id|nct_id|intervention_type|name|description
15723180|NCT05080569|Drug|Progesterone Vaginal Product|3dd200mg
15723181|NCT05080569|Drug|Placebo|3dd1 vaginal capsule
15723182|NCT05080556|Drug|Carboplatin|Treatment in both arms will be administered intravenously (IV) every 21 days (q21D) and for a maximum of 6 cycles in Arm 1 and 12 cycles in Arm 2.
15723183|NCT05080543|Drug|Albumin 20% and terlipressin|Evaluation the effect of adding 20% HSA and terlipressin on microvascular ﬂow index (MFI), flow heterogeneity index, total vessel density (TVD), and perfused vessel density (PVD) in comparison to the standard care in patient with septic shock.
15723184|NCT05080530|Drug|Cholecalciferol|Effect of Vitamin D on diabetic neuropathy symptoms
15723186|NCT05080491|Diagnostic Test|immuno analysis and neuropsychological tests|"A venous blood sample will be taken for assay in immuno-analysis including and for assay in chromatography with mass spectrometry. Patients will participate in computer neuropsychological tests: .
~Venous blood collection and the administration : the tubes are transported to the biochemistry laboratory of the University Hospital Center of Nice (CHU Nice) which prepares five aliquots (4 for assays in immuno-analysis including 2 on site, and one for assay in chromatography with mass spectrometry.
~Administration of two neuropsychological tests on computer(Attention Network Task and Tower of London)."
15723187|NCT05080478|Drug|Clopidogrel, Ticagrelor|P2Y12 inhibitors are prescribed following the PCI procedure in patients. Patients are enrolled on the study before administration of the first dose of the drug. Parameters are measured before and after drug initiation.
15723188|NCT05080465|Biological|Autologous BM MSC|A total of 100-200ml will be harvested from the subject, in either a single or multiple punctures. This will be processed for autologous MSC infusion.
15723189|NCT05080452|Diagnostic Test|Dynamic infrared thermography (DIRT)|Visualizing hot spots
15723192|NCT05080426|Behavioral|Family Supportive Supervisor Training 2.0|FSST 2.0 is a workplace intervention package designed to increase supervisors' family and leave supportive behaviors and leave supportive behaviors. The package includes Workplace Assessment tool, 2 45-60 minute online training modules (family-supportive supervisor training and supervisors' leave supportive behavior training), a webinar, behavior training, and individualized feedback reports.
15723193|NCT05080413|Device|Laser shoes|Path Finder® is a device that is fixed to the noses of the patient's shoes using a rubber strap, and laser-marks the place to be stepped on the ground of the opposite foot when walking. It is installed on both feet to relieve the symptoms of freezing of gait.
15723194|NCT05080413|Device|Metronome|The metronome, which makes a sound with a constant beat, is known to have an effect on the symptoms of Freezing of Gait in Parkinson's disease patients. At a rate of 80 beats per minute, the volume of sound that the patient can fully recognize is set to resolve the freezing of gait using the metronome sound.
15723195|NCT05080400|Dietary Supplement|White rice|Jasmine rice 179g of cooked weight
15723196|NCT05080400|Dietary Supplement|Gellan gum|Food grade hydrocolloid polysaccharide 5.5g dissolved in 356g cooking water containing 185g rice
15723197|NCT05080387|Other|Blood sample|Blood samples will obtained for measurement of neopterin level through ELIZA
15723198|NCT05080374|Other|Spinal Manipulation + exercise program|high-speed, low-amplitude spinal manipulation plus a trunk exercise program
15723199|NCT05080374|Other|Spinal manipulation + Kinesiotaping|high-speed, low-amplitude spinal manipulation plus elastic bandage (Kinesiotaping) application to the trunk area
15723200|NCT05080374|Other|spinal manipulation + respiratory exercise|high-speed, low-amplitude spinal manipulation plus a breathing exercise program for the diaphragmatic muscles
15723201|NCT05080361|Drug|BRAF inhibitor|Reports of adverse events occurring in patients treated with at least one BRAFi or MEKi as reported in the individual case safety reports.
15723202|NCT05080348|Procedure|Ropivacaine iPACK Injection|Injection of 20mL of 0.25% Ropivacaine with 1:400,000 Epinephrine between in the Interspace between the Popliteal Artery and the Capsule of the Knee (iPACK) using ultrasound guidance at the level of the femoral condyles
15723203|NCT05080348|Procedure|Normal Saline iPACK Injection|Injection of 20mL of 0.9% Normal Saline between in the Interspace between the Popliteal Artery and the Capsule of the Knee (iPACK) using ultrasound guidance at the level of the femoral condyles
15723204|NCT05080335|Other|Short videos|"As an educational RCT, the didactic content will be the same across all four arms, but its deliver will vary by:
~TRANS- vs CIS-gender female instructors
~With or without short videos of transgender youth embedded into the didactic (for the group with no embedded videos, the same videos will be shown AFTER completion of the post measures)"
15723205|NCT05080322|Drug|Fluticasone Nasal 50 Mcg/Inh Nasal Spray, Azelastine Nasal 140 Mcg/Inh Nasal Spray|on-demand INS (Fluticasone) combined with nasal spray AH1(Azelastine)
15723206|NCT05080322|Drug|Fluticasone Nasal 50 Mcg/Inh Nasal Spray|on-demand or maintenance
15723207|NCT05080309|Dietary Supplement|carbohydrate oral intake|During labor the women will have free access to water and 20 ml commercial fruit juice bricks containing between 430 or 660 kcal/l. Every 2 hours the midwife or the nurse will measure the fruit juice oral intake volume and will advise women to drink the planned volume (1 brick/2hours)
15723208|NCT05080309|Other|free water only|Women will have free access to water only
15723209|NCT05080283|Device|CP1110 Sound Processor System|Sound Processor
15723210|NCT05080283|Device|Nucleus 7 Sound Processor (model: CP1000) system|Sound Processor
15723212|NCT05080257|Device|Lung Ultrasonography|"The ultrasonography will be done using the curved probe of the SONOACE R3 SAMSUNG ultrasonography machine, SN: S0GYM3HCC00016M, manufacture date: 12-2012.
~Assessment of lung condition using the Lung Ultrasonography Score (total score calculated from the 12 standard examined areas, from 0 to 3 in each area, with a minimum of 0 up to 36)"
15723221|NCT05080205|Procedure|Bariatric surgery|Roux-en-Y gastric bypass or sleeve gastrectomy, chosen based on routine evaluation process
15723222|NCT05080192|Drug|Fenofibrate|145 mg/d of Tricor (administered as part of the parent FERMIN trial) for 10 days, or renal corrected dose equivalent (depending on renal function)
15723223|NCT05080192|Drug|Placebo|Matching placebo (once/day) for 10 days
15723224|NCT05080179|Behavioral|Self-Benefit/Social Norm|"As part of their email, they will read, It can help you determine where and when to get testing, and how to get care if you need it. and Over 650,000 Pennsylvanians have already downloaded the app!"
15723225|NCT05080179|Behavioral|Self-Benefit/No Social Norm|"As part of their email, they will read, It can help you determine where and when to get testing, and how to get care if you need it. They will not read any information about the number of Pennsylvanians who downloaded the app."
15723226|NCT05080179|Behavioral|Other Benefit/Social Norm|"As part of their email, they will read, It can help you reduce your risk of unknowingly spreading the virus to your friends, family, and larger community. and Over 650,000 Pennsylvanians have already downloaded the app!"
15723227|NCT05080179|Behavioral|Other Benefit/No Social Norm|"As part of their email, they will read, It can help you reduce your risk of unknowingly spreading the virus to your friends, family, and larger community. They will not read any information about the number of Pennsylvanians who downloaded the app."
15723228|NCT05080166|Other|Interview with Clinicians|One time, qualitative interview of clinicians for feedback on UPLYFT intervention
15723229|NCT05080166|Other|Field Test of UPLYFT with Lymphoma Survivors|6 session of UPLYFT intervention with Lymphoma Survivors for feedback
15723230|NCT05080166|Behavioral|Pilot of UPLYFT with Lymphoma Survivors|6 session of UPLYFT intervention with Lymphoma Survivors
15723231|NCT05080153|Dietary Supplement|Ocufolin forte|start of ocufolin forte 1 dd after RVP measurement, till 90 tablets are finished (3 months)
15723232|NCT05080140|Drug|Ezetimibe 10mg|Effect of ezetimibe on hyperlipidemia on patients with diabetes mellites
15723234|NCT05080114|Procedure|Modified Bakay technique (MT)|The conventional standard technique for laparoscopic hysterectomy was followed until the colpotomy. The remaining steps were as follows: A 0-Monocryl™ violet (poliglecaprone-25) or a 0-PDS-II (polydioxanone) suture with a 36-mm needle (Ethicon Inc., NJ, USA) was placed first on the right USL, proximal to the ischial spine and 1-3 cm away from its uterine insertion, then helically proceeded by 1 to 3 bite(s) (depending on the length of the ligament) for suspension/plication. The suture continued circumferentially in counter clockwise direction on the line between the cervicovaginal junction and the bladder in a full-thickness purse string fashion, at least 1 cm away to the bladder. This suture symmetrically ended in the left USL, with forming nearly an Ohm sign (Ω). Colpotomy was performed circumferentially using laparoscopic cold scissors and/or knife, maintaining a safe distance from the suture line. Following removal of the uterus, both ends of the prior suture line were knotted.
15723235|NCT05080114|Procedure|Standard technique (ST)|"The conventional standard total laparoscopic hysterectomy technique was used in this control group.
~All operations were performed under general anaesthesia with nasogastric intubation and a bladder catheter in place. Cefazolin 2 g was administered to all patients for prophylaxis 30 min prior to surgery. Operations were performed with a 10-mm laparoscope (Karl Storz, Germany) through the trocar placed usually in the umbilicus. Two lateral 5-mm trocars and one midline 10-mm trocar were used. The placement of trocars varied according to the uterine size. Haemostasis was usually performed using bipolar forceps (Karl Storz Robi, Germany), whereas dissection was performed using the LigaSure™ (Covidien, Medtronic, USA). Maryland jaw laparoscopic sealer/divider, bipolar forceps and scissors. Colpotomy was performed with electrocautery devices and sutured intracorporeally."
15723236|NCT05080101|Other|Conventional Therapy Program|Patients in control group (n=14) will receive 40-mins conventional physiotherapy session for 3-days per week, over 6 weeks. Conventional physiotherapy will consist of stretching and strengthening exercises, postural alignment exercises, as well as electrotherapy such as transcutaneous electric magnetic stimulation (TENS) which will be applied to lumbar region with a frequency of 100 Hz, 50-100 μsec current duration for 20 minutes, hotpack which will be applied to lumbar region for 20 mins, and ultrasound application which will be applied to the lumbar region with a Chattanooga Intelect Mobile device at a frequency of 1 MHz, at a dose of 1.5 W/cm2, for 6 minutes using a 10 cm2 head.
15723237|NCT05080101|Other|Basic Body Awareness Therapy Group Program|Patients in study group (n=14) will receive Basic Body Awareness Therapy (BBAT) 3 days in a week, over 6 weeks in addition to conventional physiotherapy. BBAT will consist of flexibility exercises and various cognitive exercises in supine, position, sitting position and standing position. These exercises will be consist of exercises such as body scanning, breathing, sound resonance.
15723238|NCT05080075|Biological|Platelet Rich Plasma Injection|Research participants own blood will be used to prepare the platelet rich plasma injectate, which will be injected into the affected knee using ultrasound guidance.
15723239|NCT05080062|Behavioral|Requirements and functional Schedule|An interview with the employee and the employer where the occupational worker is leading the interview and a pain rehabilitation-program
15723240|NCT05080062|Behavioral|No intervention|a pain rehabilitation-program
15723272|NCT05079763|Other|Bacterial cellulose-monolaurin hydrogel|Hydrogel containing Komagataeibacter bylines-derived bacterial cellulose, virgin coconut oil monolaurin, cucumber fragrance and distilled water
15723273|NCT05079763|Other|Placebo cream|Cream containing distilled water, white petrolatum, steady alcohol, propylene glycol, sodium laurel sulphate, methylparaben and propylparaben
15723241|NCT05080049|Drug|Erythropoietin|"Patients receive a subcutaneous injection of 40,000 IU of erythropoietin alfa, repeated weekly until Day 28 (if the hemoglobin level is <12 g/dl and the patient remains hospitalized).
~The study treatments are administered by an open-label nurse. In both groups, before each injection, iron deficiency (defined as reticulocyte Hb <29 pg, or hepcidin <41 µg/L, or ferritin <100 µg/L, or ferritin <300 µg/L with transferrin saturation <20%) is treated with intravenous iron infusion (depending on the product available at the center). A restrictive transfusion strategy is recommended as long as the patient remains in the ICU, according to recent recommendations.
~Six visits are scheduled: V1 for inclusion and the first injection, V2 at Day 7(±2 days) for the second injection, V3 at Day 14(±2 days) for the third injection, V4 at Day 21(±2 days) for the fourth injection, V5 at Day 28(±2 days) for the fifth injection."
15723242|NCT05080049|Drug|Placebo|"In the control arm, patients receive a subcutaneous injection of placebo (0.9% NaCl) according to the same schedule.
~The study treatments are administered by an open-label nurse. In both groups, before each injection, iron deficiency (defined as reticulocyte Hb <29 pg, or hepcidin <41 µg/L, or ferritin <100 µg/L, or ferritin <300 µg/L with transferrin saturation <20%) is treated with intravenous iron infusion (depending on the product available at the center). A restrictive transfusion strategy is recommended as long as the patient remains in the ICU, according to recent recommendations.
~Six visits are scheduled: V1 for inclusion and the first injection, V2 at Day 7(±2 days) for the second injection, V3 at Day 14(±2 days) for the third injection, V4 at Day 21(±2 days) for the fourth injection, V5 at Day 28(±2 days) for the fifth injection."
15723243|NCT05080036|Other|Medio-lateral imbalance|Thrust on the pelvis in the medio-lateral direction in order to create a balance perturbation
15723244|NCT05080023|Device|Enhanced External Counterpulsation (EECP)|Enhanced External Counterpulsation (EECP)
15723245|NCT05080010|Drug|3 cycles chemotherapy|Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first three months.
15723246|NCT05079997|Device|MAGNETIC RESONANCE IMAGING|s a medical imaging technique used in radiology to form pictures of the anatomy and the physiological processes of the body. MRI scanners use strong magnetic fields, magnetic field gradients, and radio waves to generate images of the organs in the body. MRI does not involve X-rays or the use of ionizing radiation, which distinguishes it from CT and PET scans. MRI is a medical application of nuclear magnetic resonance (NMR) which can also be used for imaging in other NMR applications, such as NMR spectroscopy.
15723247|NCT05079984|Behavioral|Graded exposure treatment (GET)|Graded-exposure is a theory driven, individually tailored, and evidenced based behavioral intervention for individuals with chronic pain targeting pain-related impairment by exposing patients to previously feared and avoided activities.
15723248|NCT05079971|Diagnostic Test|Group B: aEEG with concurrent multichannel (full) continuous cEEG review by clinical neurophysiology|In group B, the standart-care equivalent aEEG review is undertaken by NICU staff via a 2-channel display. In addition to the standard care, concurrent full EEG is reviewed remotely with regular feedback by a specialist trained clinical neurophysiologist. The clinical neurophysiology reports only on seizure burden, no information or direction is provided regarding clinical management.
15723249|NCT05079958|Behavioral|cognitive-behavioral education|four-week cognitive-behavioral education course
15723250|NCT05079958|Behavioral|12-week brisk walking|12-week brisk walking
15723251|NCT05079945|Procedure|Spinal cord Tractography in order to differentiate spinal tracts.|Spinal cord tractography using DTI MRI sequences of the brain and spinal cord, in order to differentiate tracts at the spinal cord level; and by performing a stitching process between Brain and Spinal cord DTI sequences.
15723254|NCT05079906|Device|Fractional Flow Reserve (FFR)|Fractional Flow Reserve (FFR) for all enrolled subjects. All interventional procedures, including FFR and HD IVUS, will be conducted in accordance with current approved User Guides and Instructions for Use.
15723255|NCT05079906|Device|High Definition Intravascular Ultrasound (HD-IVUS)|High Definition Intravascular Ultrasound (HD-IVUS) in addition to FFR for last 50 enrolled subjects. All interventional procedures, including FFR and HD IVUS, will be conducted in accordance with current approved User Guides and Instructions for Use.
15723256|NCT05079893|Other|Case control study|Observational case control study
15723257|NCT05079880|Drug|300 mg of caffeine citrate infusion|At the end of the surgery, the study drug was given intravenously over ten minutes than the sevoflurane infusion was stopped corresponding to the start of the recovery period
15723258|NCT05079880|Drug|Placebo|At the end of the surgery, the placebo was given intravenously over ten minutes than the sevoflurane infusion was stopped corresponding to the start of the recovery period
15723259|NCT05079867|Device|Cochlear implantation|Electrode surgically implanted in patient's cochlea to improve hearing
15723260|NCT05079854|Drug|Intraocular Instillation Solution|Intracameral Moxifloxacin 0.5%
15723261|NCT05079854|Drug|Moxifloxacin Ophthalmic|Topical Moxifloxacin 0.5%
15723262|NCT05079841|Device|Electric breast pump|Participants randomized to the intrapartum nipple stimulation will use electric breast pump or nipple stimulate by hand (if preferred) (intervention) to induce labor
15723263|NCT05079841|Drug|Exogenous oxytocin intravenous infusion|Participants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to induce labor
15723264|NCT05079828|Diagnostic Test|18F-PSMA-1007|PET/CT scan using 18F-PSMA-1007
15723265|NCT05079828|Diagnostic Test|68Ga-PSMA-11|PET/CT scan using 68Ga-PSMA-11
15723266|NCT05079815|Diagnostic Test|CBC and serum ferritin|take blood sample for CBC and serum ferritin
15723267|NCT05079802|Drug|Double antibiotic paste mixed with chitosan nanoparticles|Lesion sterilization and tissue repair in non-vital primary molars with double antibiotic paste mixed with chitosan nanoparticles gel
15723268|NCT05079802|Drug|Double antibiotic paste mixed with propylene glycol|Lesion sterilization and tissue repair in non-vital primary molars with double antibiotic paste mixed with propylene glycol
15723269|NCT05079789|Drug|Amiloride|Treatment with amiloride, start dose 5 mg
15723270|NCT05079789|Drug|Furosemide|Treatment with furosemide, start dose 40 mg
15723441|NCT05078255|Other|Semaglutide 1.34 mg/ml placebo|Saline
15723274|NCT05079750|Biological|ChAdOx1 biEBOV|ChAdOx1 biEBOV provided as a liquid in glass vials and administered intramuscularly into the deltoid of the non-dominant arm (preferably)
15723275|NCT05079737|Other|Mutation Burden|Subjects will have their facial samples analyzed for DNA mutation burden.
15723277|NCT05079711|Device|SavvyCheck Vaginal Yeast Test (rapid, point-of-care diagnostic test)|The SavvyCheck Vaginal Yeast Test is a lateral flow immunochromatographic qualitative test for detection of Candida antigen in vaginal secretions, sampled by a swab as an aid for identification of vulvovaginal candidiasis (VVC), as a primary cause of vaginal yeast infections. The SavvyCheck Vaginal Yeast Test is designed for use by women experiencing vaginal symptoms, including: increased vaginal discharge, vaginal itching, vaginal soreness and irritation, rash on the labia, and genital burning that may worsen during urination. The SavvyCheck Vaginal Yeast Test is indicated for OTC use.
15723278|NCT05079698|Drug|177Lu-PSMA-617|Intravenous (IV) infusion of 177Lu-PSMA-617 on Day 1 of treatment Cycles 1 and 2.
15723279|NCT05079698|Procedure|Stereotactic Body Radiotherapy (SBRT)|No later than 5 weeks (+/- 7 days) after the 2nd cycle of 177Lu-PSMA-617, patients will then undergo SBRT (900 cGy x 3 fractions).
15723282|NCT05079646|Other|class 1 and class 2 cavity preparation and restored with contemporary materials|class 1 and class 2 cavities prepared in extracted teeth after endodontic procedure and then these cavities were filled with new contemporary core buildup materials.
15723283|NCT05079633|Biological|Homologous boost schedule|1st dose mRNA 1273 , 2nd dose mRNA 1273
15723284|NCT05079633|Biological|Heterologous boost schedule|1st dose mRNA 1273 , 2nd dose MVC COV1901
15723285|NCT05079620|Drug|Ceftriaxone|If there is low risk for P. aeruginosa and/or methicillin-resistant staphylococcus aureus (MRSA), as deemed by the treating team: Ceftriaxone 2 g IV, every 24 hours for 5 days
15723286|NCT05079620|Drug|Amoxicillin clavulanic acid|At any point after 24 hours, clinicians may (but are not required to) transition stable patients on ceftriaxone to the oral agent Amoxicillin + clavulanate (Augmentin) 875 mg PO or per feeding tube, twice daily for the remainder of 5 days
15723287|NCT05079620|Drug|Cefepime|If there is significant risk of P. aeruginosa and/or MRSA as deemed by the treating team: Cefepime 2 g IV, every 8 hours for 5 days, plus vancomycin
15723288|NCT05079620|Drug|Vancomycin|If there is significant risk of P. aeruginosa and/or MRSA as deemed by the treating team: Vancomycin IV, dosed by trough or AUC/MIC (area under the curve/minimum inhibitory concentration) monitoring for 5 days, plus cefepime. Order nasal MRSA swab and consider discontinuing vancomycin if MRSA swab is negative.
15723289|NCT05079620|Drug|Levofloxacin|At any point after 24 hours, clinicians may (but are not required to) transition stable patients on cefepime to levofloxacin PO or per feeding tube, 750 mg every 24 hours for the remainder of 5 days
15723290|NCT05079607|Other|Mitopure Topical Formula 1|topical skin cream containing the low dose mitophagy activator Mitopure
15723291|NCT05079607|Other|Mitopure Topical Formula 2|topical skin cream containing the high dose mitophagy activator Mitopure
15723292|NCT05079594|Other|Mother voice|"Five minutes before the procedure, the mother's voice recording will be played to the baby and the speaker will be placed 30 cm away from the baby. The baby's comfort level will be evaluated by the researcher using the Neonatal Comfort Behavior Scale 2 minutes before the procedure begins. Physiological values of the baby will be noted by the researcher 1 minute before the procedure.As soon as the heel blood procedure is completed, the baby's physiological values and comfort level will be noted by the Newborn Comfort Behavior Scale by the researcher. After the procedure, the recording will continue to be played until the baby's mother's voice returns to the basal values. Physiological values and comfort levels of the baby will be noted by the researcher 1 minute and 2 minute after the procedure. 2 minutes after the procedure, the baby's comfort level will be evaluated by the researcher using the Neonatal Comfort Behavior Scale."
15723293|NCT05079594|Other|White noise|"Before Operation The decibel meter will be set to an average of 50-60 dB and the speakers will be played at a distance of 30 cm.
~Intervention in this group will be made at the elevation. White noise will be played five minutes before the procedure.The baby's comfort level and physiological values will be evaluated by the researcher using the Neonatal Comfort Behavior Scale 2 minutes before the procedure begins.
~Order of Operation As soon as the heel blood procedure is completed, the baby's physiological values and comfort level will be noted by the Newborn Comfort Behavior Scale by the researcher.
~Post-Processing After the procedure, white noise will continue to be listened to until the baby's physiological values return to basal values. Physiological values and baby's comfort level of the baby will be noted by the researcher 1 minute and 2 minute after the heel blood collection is completed."
15723295|NCT05079568|Device|Oculus Go VR headset|Virtual reality programs consisting of interactive games, meditation and deep breathing exercises, and passive virtual reality experiences designed to facilitate relaxation.
15723296|NCT05079568|Device|Sham Oculus Go VR headset|Virtual reality program with two-dimensional nature video
15723297|NCT05079555|Device|Robotic rehab|Patients using the robotic platform SWalker
15723298|NCT05079542|Procedure|Timepoint of Implant placement of Bonelevel tapered implants|Implant surgery on different time points
15723442|NCT05078255|Other|GIP placebo|Saline
15772292|NCT04676893|Drug|CKD-388 Tab.|1T
15723299|NCT05079542|Combination Product|Material for tooth restoration - Lithiumdisilicate glass ceramic or zirconia|Tooth restoration with a certain material
15723300|NCT05079529|Drug|β-1,3/1,6-D-Glucan From Mycelia Extract of Indonesia's Ganoderma Lucidum Group|Takes β-1,3/1,6-D-Glucan capsule 3 times daily for 90 days
15723301|NCT05079529|Drug|Placebo Group|Takes placebo capsule 3 times daily for 90 days
15723302|NCT05079516|Other|Theta burst transcranial magnetic stimulation|Real or sham continuous theta burst TMS (cTBS) will be delivered to a location on the head, determined by randomized group assignment. cTBS consists of 600 low-intensity TMS pulses delivered over 40 seconds in a pattern of 50 Hz triplets delivered at 5 Hz.
15723303|NCT05079503|Drug|GEN-001|GEN-001, Lactobacillus lactis is a live, purified facultative anaerobic gram-positive probiotic lactic acid bacterial strain. GEN-001 is orally administered once daily during total TNT periods.
15723304|NCT05079490|Behavioral|motor intervention|gross motor skill intervention combined with fitness training
15723305|NCT05079477|Behavioral|Exposure to sugar-sweetened beverage warning labels|Graphic images of the amount of sugar (randomly assigned teaspoons, packets, or cubes) and text warning labels
15723306|NCT05079477|Behavioral|Exposure to calorie information|Calories for all beverages and foods
15723307|NCT05079464|Other|tDCS|All participants randomized to tDCS will receive active tDCS
15723308|NCT05079464|Other|Exercise|Participants will exercise at Toronto Rehab.
15723309|NCT05079464|Other|Sham stimulation|The same procedure for tDCS will be used for the sham condition, except without active current.
15723310|NCT05079464|Other|Treatment as usual|Exercise education/ treatment as usual will include routine advice about physical activity.
15723313|NCT05079438|Drug|Dendrobium Huoshanense Suppository|1.7g rectal administration per day for 5 weeks
15723314|NCT05079425|Drug|NXC736|Oral administration
15723315|NCT05079425|Drug|Placebo|Oral administration
15723316|NCT05079412|Other|Chest ultrasound|Chest ultrasound will be performed to eligiable (consented) patient after being on the respiratory support (NIV-NAVA vs NIPPV) for at least 24 hours. Both diaphragmatic function and lung ultrasound score will performed. Investigator interpreting the scans will be blind to patients type of respiratory support or clinical status.
15723317|NCT05079399|Other|Blood draw|Blood samples will be collected via venipuncture
15723318|NCT05079386|Device|New Voice Prosthesis|Replacement of the current prosthesis with the experimental device and use the New Voice Prosthesis for the duration of two weeks with the option of leaving the device in situ until replaced for device failure or other reason, with a maximum of 12 months.
15723319|NCT05079360|Drug|Sabizabulin|32mg each day by mouth
15723320|NCT05079360|Drug|Exemestane monotherapy, exemestane plus everolimus, or selective estrogen receptor modulator|Subjects in the Control Treatment Group will receive an ER targeted therapy limited to exemestane monotherapy, exemestane plus everolimus, or selective estrogen receptor modulator (SERM) approved for the treatment of breast cancer and is part of the standard of care at the clinical study site until disease progression is observed and confirmed by BICR. The investigator decision of which comparator treatment will be used will be made prior to randomization.
15723321|NCT05079347|Diagnostic Test|HIV rapid test|Using a rapid test to assess a patient's HIV status
15723322|NCT05079334|Behavioral|MeTree Questionnaire|"MeTree is a patient driven risk assessment program with Clinical Decision Support (CDS) that enables collection of a three plus generation family health history (FHH) on 128 conditions. CDS is provided in a report with a pedigree and tailored evidence-based guidelines. While patient drive, MeTree also includes a provider-facing report with additional references. These reports promote engagement by both patients and providers and enhance shared decision-making.
~MeTree first generates information imported from the participant's EHR record. These data include basic demographic information, any recent lab results, and any listed diseases or conditions from the EHR. Next, MeTree gives the participant an opportunity to fill out a family history tree. The more information the participant provides on their own health and their family member's health, the better MeTree can provide recommendations from current literature."
15723323|NCT05079321|Device|Hydra-PEG|Zen™ RC scleral lenses (Hydra-PEG coated)
15723324|NCT05079321|Device|Uncoated|Zen™ RC scleral lenses (non-coated)
15723328|NCT05079282|Drug|ONO-4685|ONO-4685 is administered by IV infusion. The administration of ONO-4685 will be continued until disease progression or unacceptable toxicity is observed
15723329|NCT05079269|Other|Crystalloid Solutions|As above
15723330|NCT05079256|Device|595 nm Pulsed dye laser (Candela V-beam perfecta)|595 nm pulsed dye laser therapy. 2 treatments Fluence ~ 6 - 9 J/cm^2 Pulse duration ~ 0.45 - 3.0 ms 33% overlap.
15723331|NCT05079243|Biological|Scaffold and adipose-derived stromal cell enriched fat grafts|eight different solutions of fat, ASCs, scaffold and CO2 laser in dermis three different solutions of fat, ASCs and scaffold in the subcutaneous layer
15723332|NCT05079230|Drug|Magrolimab|Administered intravenously (IV)
15723333|NCT05079230|Drug|Venetoclax|Tablets administered orally
15723334|NCT05079230|Drug|Azacitidine|Administered according to region-specific drug labeling, either subcutaneously (SC) or intravenously (IV)
15723335|NCT05079230|Drug|Magrolimab Placebo|Administered intravenously (IV)
15723340|NCT05079152|Biological|COVAX+PPV23;COVAX+IIV4|1st dose : combined vaccination of COVAX+PPV23; 2nd dose: combined vaccination of COVAX+IIV4
15723341|NCT05079152|Biological|COVAX only (1st and 2nd dose)|1st dose: COVAX only; 2nd dose: COVAX only
15723342|NCT05079152|Biological|PPV23 for the 1st dose and IIV4 for the 2nd dose|1st dose: PPV23 only; 2nd dose: IIV4 only
15723343|NCT05079139|Procedure|surgical technique of Musset|"The one-stage rectovaginal fistula cure according to Musset is an intervention indicated in the treatment of simple post-obstetrical or simple post-surgical rectovaginal fistulas.
~The procedure consists in performing a perineal section to the perineal section to the fistula pathway in order to perform local excision followed by a repair plane by plane with rectal and anal closure, then of the external sphincter of the anus, and interposition of the deep and superficial transverse elevator and perineal muscles before closing the vagina and perineum."
15723346|NCT05079100|Other|postpartum contraception method counselling|It will be face-to-face counseling with females about the use of postpartum contraception methods within 6 weeks postpartum.
15723347|NCT05079087|Procedure|Pericapsular nerve group blockade|The PENG-block will be administered under ultrasound (US) guidance with a low frequency curvilinear probe. The probe will be placed parallel to the inguinal crease at the level of the anterior superior iliac spine. Scanning will be done with gradual caudal movement of the probe. After the anterior inferior iliac spine (AIIS) is visible, the probe will be turned slightly medial until the hyperechoic continuous shadow of the superior pubic ramus is visible. The Psoas muscle with its prominent tendon will be identified just above the pubic ramus. The target is the plane between the 2 structures. While aligning the pubic ramus in the center of the image and targeting the pubic ramus just medial to the AIIS, a 22 Go 10 cm needle will be introduced and 20 ml of anesthetic solution administered.
15723348|NCT05079087|Drug|Midazolam Ketamine arm|Patients in the second group will undergo sedation and analgesic treatment with Ketamine and Midazolam titrated to the best Verbal Rating Score without respiratory and cardiovascular depressant effect.
15723350|NCT05079061|Drug|Misoprostol|sublingual misoprostol 600 micrograms in addition routine uterotonics at third stage of labour
15723351|NCT05079048|Other|PEEK retentive elements|received implant-supported mandibular overdenture retained by PEEK retentive element and housings
15723352|NCT05079035|Biological|TTAX03|Lyophilized and Micronized Particulate Human Amniotic and Umbilical Cord
15723353|NCT05079035|Biological|Saline|2 mL Sterile, preservative free 0.9% NaCl
15723354|NCT05079022|Drug|Furmonertinib|Furmonertinib at 80mg dose will be administered orally once daily.
15723355|NCT05079009|Device|ECCO2R pulsatile configuration|Use of the pulsatile extracorporeal blood flow configuration.
15723357|NCT05078970|Behavioral|Safety Planning Intervention+ (SPI+)|SPI is focused on how the risk of suicidal crisis waxes and wanes over time. At times of heightened risk, a pre-specified and individualized plan targets the internal warning signs that become the cue to use the safety plan. SPI+ strategies focus on patient's narrative of the suicidal crisis and identifying solutions that are antithetical to progressing in a suicidal crisis. The brief structured intervention is conducted in six key steps. Youth in this condition will be offered weekly follow-up, with a minimum of 4 sessions and a maximum of 8 sessions. The goal is to create a crisis response plan to reduce risk when suicidal crises emerge. With adolescents, SPI+ consists of an individual session to elicit crisis narrative and motivation to utilize the safety plan through psychoeducation and follows six steps to achieve the adolescent's goals and return to safety when suicidal urges are high.
15723358|NCT05078970|Behavioral|Collaborative Assessment and Management of Suicidality (CAMS)|CAMS strategies focus on collaborative deconstruction and treatment of the patient-defined drivers- the problems that make suicide compelling to the patient- and utilizes these problem-focused treatment sessions to treat the drivers as directly related to wish to die. Participants will be assigned to CAMS for a minimum of 4 sessions and maximum of eight sessions. This time frame, based on initial data from our pilot work with adolescents and emerging adults (18-25), suggests that a subset of participants resolve their STB in six to eight sessions. CAMS is a clinical intervention designed to modify how clinicians engage, assess and plan treatment with suicidal patients.
15723362|NCT05078944|Device|Active acupuncture|Acupoints: Principal: GV20, EX-HN1, GV24 and bilateral PC6, HT7, ST36, KI3, SP6. Additional: CV6 and bilateral GB39, ST40, SP10 Sterile stainless steel disposable acupuncture needles (size 0.30 × 50 mm, Hwato brand, China) are used. After sterilization, a small plastic ring will be fixed over the acupuncture point with plaster to facilitate maintenance of blinding for the participant, and then the needle will be inserted through the plaster inside the ring. The electric stimulator (SDZ-Ⅲ electroacupuncture apparatus, Hwato brand, China) is applied to GV20, GV24, bilateral PC6 and HT7, dilatational wave, 10/50 Hz and tolerable electric current. Needles placed in other acupoints will be manually stimulated by rotation every 15 minutes. Each session lasts for 45 min.
15723443|NCT05078242|Device|EaseVRx|Participants will experience 7 sessions of the EaseVRx device for chronic pain.
15785565|NCT04568395|Other|ECIG|Use an ECIG
15723363|NCT05078944|Device|Sham acupuncture|"Sham acupoints: SA1 (5 cun lateral to GV5), SA2 (5 cun lateral to GV4), SA3 (1 cun lateral to BL56).
~After sterilization, pragmatic placebo needles with blunt tip (size 0.30 × 50 mm, Hwato brand, China) are used. When their tips are pressed against the skin through plastic rings, participants will feel a pricking sensation. The electric stimulator is applied to bilateral SA1 and SA2 with no current output. The mental wire has been cut off with a same outlook as the electroacupuncture group. Needles placed in SA3 will be manually rotated every 15 minutes. Each session lasts for 45 min."
15723364|NCT05078944|Drug|Donepezil Hydrochloride|Donepezil hydrochloride (5 mg/capsule, Weicai Pharmaceutical Co., Ltd, China) is to be taken 5 mg daily.
15723367|NCT05078918|Other|Comprehensive care program|Comprehensive care program includes education and re-evaluation process. Education using video-materials to help patients adapt to the new normal before and after surgery. And re-evaluation patient's needs 1 month after surgery and arrangement resources.
15723368|NCT05078918|Other|Usual care|Usual care includes encouraging deep breathing and exercise using inspirometer, postoperative early ambulation, giving information at discharge and follow up 1 month after surgery.
15723370|NCT05078866|Biological|Adenoviral Tumor-specific Neoantigen Priming Vaccine GAd-209-FSP|Given IM
15723371|NCT05078866|Biological|MVA Tumor-specific Neoantigen Boosting Vaccine MVA-209-FSP|Given IM
15723372|NCT05078866|Other|Questionnaire Administration|Ancillary studies
15723373|NCT05078853|Device|Point of care assay for thyroglobulin (POC-Tg) evaluation of a suspected cervical lymph node|"FNA Clinic: When a bloody material is seen in the needle, 100 µL of 0.9% saline is drawn via the needle into the syringe. The aspirate is then transferred into an Eppendorf tube. 40 µL is aspirated from the Eppendorf tube and dripped into the middle of the sample well of the POC-Tg kit. Two drops of the buffer are then dispensed into the middle of the sample well. The result of the POC-Tg is obtained and documented after 10 minutes. To compare the accuracy of the POC-Tg kit to the formal immunoassay for Tg, 0.9% saline is added to the aspirate that was left in the Eppendorf tube to a final volume of 0.6 mL. This volume is transferred into a gel containing tube and sent to the clinical laboratory that performs Tg measurement.
~Operating room: When an indeterminate or suspicious LN is found, the LN is dissected and evaluated by both the formal evaluation and the POC-Tg. Following dissection of the LN, the ex-vivo POC-Tg is conducted as described above."
15723374|NCT05078840|Other|Evaluation of first line treatment in patients with stage I and II LBCL|Evaluation of first line treatment in patients with stage I and II LBCL, without poor prognostic factors with treatment adapted to PET-CT after 3 R-CHOP
15723375|NCT05078827|Drug|Test Product (A): Fluorouracil Cream, 5% topical cream|Apply cream twice daily in an amount sufficient to cover the lesions. Fluorouracil should be applied preferably with a nonmetal applicator or suitable glove. If Fluorouracil is applied with the fingers, the hands should be washed immediately afterward.
15723376|NCT05078827|Drug|Reference Product (B): EFUDEX® (Fluorouracil 5%) Topical Cream of Bausch Health US, LLC, USA|Apply cream twice daily in an amount sufficient to cover the lesions. Fluorouracil should be applied preferably with a nonmetal applicator or suitable glove. If Fluorouracil is applied with the fingers, the hands should be washed immediately afterward.
15723377|NCT05078827|Drug|Placebo Product (C): Test vehicle cream for fluorouracil 5% of Encube Ethicals Pvt. Ltd., India|Apply cream twice daily in an amount sufficient to cover the lesions. Fluorouracil should be applied preferably with a nonmetal applicator or suitable glove. If Fluorouracil is applied with the fingers, the hands should be washed immediately afterward.
15723378|NCT05078814|Other|Observational research|Observational research
15723379|NCT05078801|Procedure|Endoscopic drainage|ERCP and/or EUS-guided biliary drainage
15723380|NCT05078801|Procedure|Percutaneous transhepatic biliary drainage|US or CT-guided percutaneous drainage
15723381|NCT05078788|Procedure|Laser uretherotomy|Holmium YAG Laser with pulse energy from 1-2 Joule, frequency from 10-15 Hertz and total power from 3.0 to 30.0 Watt were set up, respectively, based on the extent of the lesions. Scar tissue was incised at the position of 12-o'clock under the guidance of guidewire or ureteric catheter till fresh mucosa appeared.
15723382|NCT05078788|Procedure|Laser uretherotomy with triamcinolone|After laser urethrotomy, 80 mg of triamcinolone (diluted with normal saline to 10 ml) will be injected by using an injection needle (5 F size and 23 G needle size) at 10 sites, 1 ml each, along the site of urethrotomy and circumferentially.
15723383|NCT05078775|Other|NEAAR Medical Food|All subjects will receive NEAAR Medical Food, a standardized non-essential amino acid restricted medical food, and will also receive standard of care FDA approved chemotherapy consisting of gemcitabine and nab-paclitaxel.
15723384|NCT05078762|Other|Immersive Virtual Reality|Training in an iVR environment with Virtual Reality Goggles while using the bronchoscopy simulator, while the control group will train without VR goggles.
15723385|NCT05078749|Other|Exercise training group|A regular advanced exercise program will be given and followed.
15723386|NCT05078749|Other|Control training group|Basic exercises will be given at the beginning and will do the same exercises
15723387|NCT05078736|Other|Moderate intensity intermittent training|In group A participants will receive moderate intensity intermittent training including running of 5 km with 1-min at 70% of maximal aerobic speed with interval of 1-min passive recovery, exercises will be performed by gym trainer for 5 weeks including 3 days/week
15723388|NCT05078736|Other|Moderate intensity continuous training|In group B participants will receive moderate intensity continuous training ran continuously the same 5 km at 70% of maximal aerobic speed, exercises will be performed by gym trainer for 5 weeks including 3 days/week.
15723694|NCT05076149|Drug|Placebo (matched to IVA)|Placebo matched to IVA for oral administration.
15723389|NCT05078723|Dietary Supplement|Limonene|The investigators will ask the participants to swish 5 times and swallow 1 oz water mixed with 500mg limonene (Jarrow Formula orange peel extract). The participant will be monitored for a total of 2 hours. Breath samples will be acquired at a total of 11 time points throughout the study. Measurements include 2 baseline measurements followed by the orange peel extract consumption.
15723390|NCT05078710|Drug|Telitacicept|160mg once a week for 24 weeks
15723393|NCT05078671|Drug|Olaparib|olaparib treatment
15723394|NCT05078671|Drug|Cobicistat|Pharmacokinetic booster
15723395|NCT05078658|Other|Low-carbohydrate diet|The diet will contain age- and gender-specific recommended amount of calories but the amount of carbohydrates would be limited to provide only 15% (+/- 5%) of the recommended energy a day.
15723396|NCT05078658|Other|Recommended-carbohydrate diet|The subjects will be delivered five pre-made ready meals per day throughout the period (5 weeks). These will contain age- and gender-specific recommended amount of calories with the amount of carbohydrates equal to 45% (+/- 5%) of the recommended energy a day.
15723397|NCT05078645|Device|Maya|The Maya is a cover which can be placed over the end of the patients bed. The Maya aims to reduce light and sound nuisances and enhance patients' privacy
15723398|NCT05078632|Other|Montreal-Toulouse Test adapted in eye tracking|participant pass an eye tracking test to evaluate comprehension
15723399|NCT05078619|Procedure|No PCI|Omission of PCI of significant coronary artery disease prior to TAVI
15723404|NCT05078580|Drug|Iptacopan|Single oral dose of iptacopan
15723405|NCT05078580|Drug|Iptacopan|Single oral dose of iptacopan
15723406|NCT05078580|Drug|Iptacopan|Single oral dose of Iptacopan
15723407|NCT05078580|Drug|Iptacopan|Single oral dose of Iptacopan
15723408|NCT05078567|Device|5% Natural Lactic Acid-enriched Cream|The subjects were required to topically apply natural lactic acid-enriched cream twice daily in the morning and evening for the treatment duration of 12 weeks.
15723409|NCT05078541|Procedure|Ultrasound-guided Radiofrequency Ablation of Parotid Warthin's Tumor|"The Procedure
~Injection of local subcutaneous and pericapsular anaesthesia
~Needle radiofrequency ablation under ultrasound guidance
~Patients should communicate with operating surgeon upon excessive heat or pain
~The procedure usually lasts 30-45 minutes"
15723410|NCT05078528|Device|Multimodal Mobile Colposcope (MMC)|Women referred for colposcopy due to abnormal cervical screening or follow-up for a history of dysplasia will be recruited into the experimental group of the study. Imaging of study participants will take place during the colposcopy examination.
15723411|NCT05078515|Diagnostic Test|PREDICT score|Predictive score for local recurrence after TME for rectal cancer that includes 8 parameters
15723413|NCT05078489|Other|Action-observation therapy|Action observation therapy involves the observation and perception of human movement performed by others. the observation of actions performed by others activates in the perceiver the same neural structures responsible for the actual execution of those same actions.
15723414|NCT05078489|Other|Placebo|Participants will watch a natural landscape without any human.
15723415|NCT05078476|Other|Manchester Short Splint|3-5 days after tendon repair the patient will start with hand therapy and the described protocol.
15723416|NCT05078476|Other|Relative Motion Flexion|3-5 days after tendon repair the patient will start with hand therapy and the described protocol.
15723417|NCT05078463|Device|Microneedle|Maltose Microneedle Patch (Patch Size: 10 mm x 10 mm, 36 microneedles per patch, microneedle's height, base width and tip radius are 400 μm, 100 μm and 3 μm, respectively) will be firmly applied for 5 seconds on the 1 cm x 1 cm site for IV cannulation on the dorsal surface of the hand for blood transfusion, prior to EMLA cream application.
15723418|NCT05078463|Drug|2 Finger Tip Units (FTUs) EMLA Cream (30-minute application time)|2 Finger Tip Units (FTUs) EMLA applied for 30 minutes on the dorsal surface of the IV cannulated hand for blood transfusion
15723419|NCT05078463|Drug|2 Finger Tip Units (FTUs) EMLA (15-minute application time)|2 Finger Tip Units (FTUs) EMLA applied for 15 minutes on the dorsal surface of the IV cannulated hand
15723420|NCT05078463|Drug|1 Finger Tip Unit (FTU) EMLA (30-minute application time)|1 Finger Tip Unit (FTU) EMLA applied for 30 minutes on the dorsal surface of the IV cannulated hand for blood transfusion
15723421|NCT05078463|Device|Sham Patch|A Polyvinyl Alcohol (PVA)-containing Polyethylene Terephthalate (PET) Sham Patch will be applied for 5 seconds against the pre-specified 1 cm x 1 cm grid on the dorsal surface of the IV cannulated hand for blood transfusion.
15723424|NCT05078424|Behavioral|Cognitive Behavioural Therapy|CBT is a well-established, evidence-based intervention frequently used for easing depressive and anxiety symptoms. The intervention will be delivered for 6-7 sessions, each session lasts for 1.5 hours, in the format of a group for a period of 6-7 weeks by frontline social or youth workers trained by professional CBT clinicians. Core treatment components include mood monitoring, emotion education, behavioural activation, emotion cycle/ ABC model, identification of automatic thoughts, and cognitive restructuring. It is designed to improve youths' abilities/ skills in handling their moods to have better emotional management.
15723427|NCT05078398|Behavioral|POINT Protocol|Patients will receive counseling on risks and benefits of opioids for pain control, asked to choose whether they need opioid prescription when ready for discharge.
15723428|NCT05078398|Behavioral|Usual care|Will prescribe standardized amount of opioid for postoperative pain without patient input
15723429|NCT05078385|Drug|AGLE-102|In this protocol, 2nd degree burn wounds will receive direct application of EVs derived from bone marrow MSCs. We have observed success with this type of approach in the past using bone marrow stem cells including MSCs. We have evidence that EVs derived from MSCs are responsible for many of the healing effects produced by MSCs and may be a safer, more reliable alternative to allogeneic cell therapy. This protocol is designed to develop a safe and ideal method of administering bone marrow cell Extracellular Vesicles to wounds.
15723430|NCT05078372|Drug|ropivacaine and midazolam intraarticular administration|Patients undergoing ACL reconstruction with hamstring autograft who will receive ropivacaine and midazolam epidural administration for anesthesic technique for the procedure, and intraarticular administration of those drugs.
15723431|NCT05078372|Drug|ropivacaine and midazolam epidural administration|Patients undergoing ACL reconstruction with hamstring autograft who will receive ropivacaine and midazolam epidural administration for anesthesic technique for the procedure
15723432|NCT05078359|Diagnostic Test|Prostate Magnetic resonance Imaging|Magnetic resonance imaging (MRI) uses a magnetic field, radiofrequency pulses, and a computer to produce detailed pictures of the organ. Prostate MRI evaluate the presence and extent of prostate cancer and determine whether it has spread around the organ
15723435|NCT05078320|Behavioral|Exposure and response prevention (ERP)|"The treatment is Internet-delivered and therapist-guided, involving both the adolescent and at least one parent. The treatment consists of two separate sets of modules, one for the adolescent and one for the parent, each with separate logins. The ICBT intervention consists of 12 modules, delivered over a maximum of 14 weeks.
~The main goal of treatment is to help the young person to stop avoiding anxiety-provoking situations by undertaking exposure tasks and to stop doing unhelpful repetitive behaviours and rituals, known as response prevention. Every module also contains homework tasks that mainly consists of exposure and response prevention (ERP).
~Parents are also often involved in the patients' rituals and avoidant behaviours (known as family accommodation), which may contribute to maintain the BDD symptoms. Involving parents facilitates modification of these unhelpful patterns."
15723436|NCT05078307|Procedure|OHR VS OHV|"Control group : use of the OHR system to perform an Operative Hysteroscopy by Resection of the fibroid.
~Experimental group : use of the OHV system to perform an Operative Hysteroscopy by Vaporization of the fibroid."
15723439|NCT05078255|Drug|Semaglutide 1.34 MG/ML [Ozempic]|Semaglutide 1.34 mg/ml
15723440|NCT05078255|Drug|Glucose-dependent insulinotropic polypeptide (GIP)|GIP
15723444|NCT05078229|Behavioral|FOCUS|There will be 6 one on one sessions, either in person or via video conference. The 6 sessions will last between 45-60 minutes. Topics of the sessions will be Mindfulness for the Caregivers, Awareness of Stressors, Skillful Actions, Thoughts, Self-Care and Balance and Planning for the Future. There will be meditation during the sessions and then recommended daily at home mindfulness practice.
15723445|NCT05078229|Behavioral|Healthy Living|There will be 6 one on one sessions, either in person or via video conference. The 6 sessions will last between 45-60 minutes. Topics of sessions will be Overview of Cancer, Eating Well, Exercise, Cancer Prevention, Sleep and Finances.
15723446|NCT05078216|Other|Physical exercise intervention|"12-week supervised intervention, 90 minutes sessions twice per week All sessions had the same structure: 10 min of warm-up at 60-70% maximal heart rate (MHR), followed by 60-70 minutes of specific training and 10 minutes of stretching exercises. At least, 20% of the total session time was based on cardiovascular work over 70% of the maximum heart rate (MHR).
~Fitness work in the first eight sessions was planned following 30 min of time on cardiovascular exercise 55 min on work out in low to moderate intensity. In the next eight sessions, the time spent on cardiovascular work was slightly increased to 35 min, with 50 min focused on work out, combining moderate to high-intensity sessions. The last eight sessions presented the same structure as the first ones but combining moderate to high intensity."
15723447|NCT05078203|Behavioral|Exercise|Individuals will warm up for 3 minutes before exercising for 30 minutes at an intensity derived from their graded exercise test before cooling down for 3 minutes (36 minutes).
15723449|NCT05078177|Drug|Rituximab|All patients receive AHSCT with RIC (Cyclophosphamide, Antithymocyte globulin/Rituximab). After resolution of cytopenia (approximately from about D+12 to D+14 AHSCT), patients will receive intrathecal Rituximab.
15723450|NCT05078164|Behavioral|Bridging the Gap (BTG)|"Bridging the Gap: Bridging the Gap is a hybrid model for violence prevention which integrates a hospital-based brief violence intervention (BVI) delivered to the patient while in hospital with a wrap-around community case management prevention strategy.
~Firearm Counseling Program: The firearm counseling program was developed to be administered in the hospital alongside the 6-step intervention program, as well as in the patient's home after hospital discharge. The firearm safety counseling program includes 3 components aimed at understanding patient risk, reducing firearm-related violence risk-factors, and helping patients increase firearm safety practices."
15723451|NCT05078151|Diagnostic Test|Whole-Body Diffusion Weighted MRI|MRI at baseline, after four and eight weeks of treatment and at disease progression or treatment discontinuation.
15723452|NCT05078138|Drug|Epoetin Alfa|Subcutaneous injection of Epoetin Alfa 3 times per week for 4 weeks
15723453|NCT05078138|Other|Saline|Subcutaneous injection of saline times per week for 4 weeks
15723455|NCT05078112|Device|Sleep sensor technology|Infants will sleep on a novel device with built-in sensor technology that tracks sleep patterns and provides output based on historical sleep data.
15723456|NCT05078099|Device|CureSight|Binocular eye-tracking-based passive home treatment system delivering personalized amblyopia therapy
15723457|NCT05078086|Other|No intervention|No intervention
15723458|NCT05078073|Device|Hyperbaric oxygen therapy|Patients with aGVHD treated with HBOT every two days
15723459|NCT05078060|Biological|Quadrivalent Influenza Vaccine|Intramuscular or subcutaneous administration
15723460|NCT05078060|Biological|High-Dose Quadrivalent Influenza Vaccine|Intramuscular administration
15723461|NCT05078047|Drug|Reduced dose intensity of IO|After 6 months of treatment with standard IO, IO will be administered every 3 months (at the same dose levels) until disease progression, unacceptable toxicity, death or patient's choice or investigator's decision
15723464|NCT05078021|Diagnostic Test|Bronchoscopy|Bronchoscopy will be performed in all groups with endobronchial biopsies, brushings and bronchial washing performed.
15723465|NCT05078008|Procedure|Physiotherapy modalities|parafango in the lumbar region 20min/day; High frequency Transcutaneous Electrical Nerve Stimulation (TENS), 100 Hz, 0,04-0,2mseg, 20 min/day; lumbar flexibility self-exercise plan
15723466|NCT05078008|Procedure|Balneotherapy modalities|Immersion in a thermal pool with 15 minutes of automatic hydromassage and 15 minutes of spine flexibility exercises; thermal steam treatment to spinal column; hydromassage bath with Vichy thermal water
15723467|NCT05077995|Device|Polar M200|Participants will have to wear the activity monitors (AP and Polar M200) for at least 7 days. Minutes spent in each activity type will be summed to a total day score. Participants will be instructed to do their regular daily life activities without limitation, but to note their main activity categories in an activity diary, with a main focus on cycling and participation in structured exercise.
15723468|NCT05077982|Diagnostic Test|Spirometry|Spirometry to assess lung function
15723469|NCT05077982|Diagnostic Test|6-minute walk|Exercise tolerance
15723470|NCT05077969|Drug|Famotidine|80 mg tablet, QID for 14 days
15723471|NCT05077969|Drug|Celecoxib|400 mg (initial dose), then 200 mg capsule, BID for 5 days
15723472|NCT05077969|Drug|Placebo|tablet, QID for 14 days; capsule, BID for 5 days
15723474|NCT05077943|Behavioral|Breathing and chest mobilization exercises|Patients walk regularly 5 times per week and increase the distance day by day according to their improved ability. Patients also do breathing and chest mobilization exercise 3 times per week. It is a recorded moderated exercise for 30 minutes duration. Patients can access the video as a home-based activity through an online videos platform and will be supervised.
15723475|NCT05077943|Behavioral|Second phase cardiac rehabilitation|Independently, patients walk regularly 5 times per week and increase the distance day by day according to their improved ability without breathing and chest mobilization exercise.
15723476|NCT05077930|Biological|Convalescent plasma|The intervention group will receive 200 or 400 mL of high-titer COVID-19 convalescent plasma, ABO compatible with the patient, within 24 hours of randomization.
15723477|NCT05077930|Drug|Standard of care|The active comparator group will receive oxygen supplementation, corticoids, antiretrovirals, and/or monoclonal antibodies according to the institutional protocol.
15723480|NCT05077904|Drug|Staccato alprazolam|"Route of administration: Inhalation
~Participants will receive one dose of Staccato alprazolam during the Treatment Period."
15723481|NCT05077904|Other|Placebo|"Route of administration: Inhalation
~Participants will receive one dose placebo during the Treatment Period."
15723482|NCT05077878|Biological|DSPP level in GCF|quantification of DSPP
15723487|NCT05077826|Device|North Coast Medical Activadose II|tES device model Activadose II (North Coast Medical, Morgan Hill, CA, USA) programed to deliver tES.
15723488|NCT05077813|Combination Product|13 cis retinoic acid, Minocycline, Chicroic Acid and Vitamin D for (MDR-TB)|A) Minocycline i.v. 4,5 mg/kg gradual in 2 divided doses increases from 4,5 mg/kg from the first week to 7.5 and 10 mg/kg to the last week. In addition to Aerosolized 13 cis retinoic acid in gradual 2 divided doses increases from 0.2 mg/kg/day to 4 mg/kg/day as inhaled retinoic acid therapy for 30 days. Moreover, the patients will receive Echinacea Purpurea Extract Capsules Polyphenols Chicoric Acid. Echinacea phytochemical profile Each tablet is comprised of the equivalent of 1275 mg of echinacea root, as follows: A) Echinacea purpurea - 675 mg root yields 112.5 mg dried extract, standardized to contain 2.1mg alkamides. Each batch of tablets contain choric acid = 3.4 to 8.5 mg/tablet. Furthermore, the patients will receive Cholecalciferol(Vitamin D) Intramuscular injection of 600,000 units of Cholecalciferol for 2 doses given at week 0 and week 4
15723489|NCT05077813|Combination Product|9 cis retinoic acid, Minocycline, Chicroic Acid and Vitamin D for (MDR-TB)|A) Minocycline i.v. 4,5 mg/kg gradual in 2 divided doses increases from 4,5 mg/kg from the first week to 7.5 and 10 mg/kg to the last week. In addition to Aerosolized 9 cis retinoic acid in gradual 2 divided doses increases from 0.2 mg/kg/day to 4 mg/kg/day as inhaled retinoic acid therapy for 30 days. Moreover, the patients will receive Echinacea Purpurea Extract Capsules Polyphenols Chicoric Acid. Echinacea phytochemical profile Each tablet is comprised of the equivalent of 1275 mg of echinacea root, as follows: A) Echinacea purpurea - 675 mg root yields 112.5 mg dried extract, standardized to contain 2.1mg alkamides. Each batch of tablets contain choric acid = 3.4 to 8.5 mg/tablet. Furthermore, the patients will receive Cholecalciferol(Vitamin D) Intramuscular injection of 600,000 units of Cholecalciferol for 2 doses given at week 0 and week 4
15723490|NCT05077813|Combination Product|All trans retinoic acid , Minocycline,Chicroic Acid and Vitamin D for (MDR-TB)|Active Comparator: All trans retinoic acid , Minocycline,Chicroic Acid and Vitamin D 50 Subjects will be randomly assigned to receive A) Minocycline i.v. 4,5 mg/kg gradual in 2 divided doses increases from 4,5 mg/kg from the first week to 7.5 and 10 mg/kg to the last week. In addition to Aerosolized All trans retinoic acid in gradual 2 divided doses increases from 0.2 mg/kg/day to 4 mg/kg/day as inhaled retinoic acid therapy for 30 days. Moreover, the patients will receive Echinacea Purpurea Extract Capsules Polyphenols Chicoric Acid. Echinacea phytochemical profile Each tablet is comprised of the equivalent of 1275 mg of echinacea root, as follows: A) Echinacea purpurea - 675 mg root yields 112.5 mg dried extract, standardized to contain 2.1mg alkamides. Each batch of tablets contain choric acid = 3.4 to 8.5 mg/tablet. Furthermore, the patients will receive Cholecalciferol(Vitamin D) Intramuscular injection of 600,000 units of Cholecalciferol for 2 doses given at week 0 and week 4
15723491|NCT05077813|Combination Product|All trans retinoic acid, Minocycline, Chicroic Acid and Vitamin D For (COVID-19 and MDR-TB)|50 Subjects with confection of COVID-19 and multidrug-resistant tuberculosis (MDR-TB) will be randomly assigned to receive A) Minocycline i.v. 4,5 mg/kg gradual in 2 divided doses increases from 4,5 mg/kg from the first week to 7.5 and 10 mg/kg to the last week. In addition to Aerosolized All trans retinoic acid in gradual 2 divided doses increases from 0.2 mg/kg/day to 4 mg/kg/day as inhaled retinoic acid therapy for 30 days. Moreover, the patients will receive Echinacea Purpurea Extract Capsules Polyphenols Chicoric Acid. Echinacea phytochemical profile Each tablet is comprised of the equivalent of 1275 mg of echinacea root, as follows: A) Echinacea purpurea - 675 mg root yields 112.5 mg dried extract, standardized to contain 2.1mg alkamides. Each batch of tablets contain choric acid = 3.4 to 8.5 mg/tablet. Furthermore, the patients will receive Cholecalciferol(Vitamin D) Intramuscular injection of 600,000 units of Cholecalciferol for 2 doses given at week 0 and week 4
15723492|NCT05077813|Combination Product|13 cis retinoic acid, Minocycline, Chicroic Acid and Vitamin D For (COVID-19 and MDR-TB)|50 Subjects with confection of COVID-19 and multidrug-resistant tuberculosis (MDR-TB) will be randomly assigned to receive A) Minocycline i.v. 4,5 mg/kg gradual in 2 divided doses increases from 4,5 mg/kg from the first week to 7.5 and 10 mg/kg to the last week. In addition to Aerosolized 13 cis retinoic acid in gradual 2 divided doses increases from 0.2 mg/kg/day to 4 mg/kg/day as inhaled retinoic acid therapy for 30 days. Moreover, the patients will receive Echinacea Purpurea Extract Capsules Polyphenols Chicoric Acid. Echinacea phytochemical profile Each tablet is comprised of the equivalent of 1275 mg of echinacea root, as follows: A) Echinacea purpurea - 675 mg root yields 112.5 mg dried extract, standardized to contain 2.1mg alkamides. Each batch of tablets contain choric acid = 3.4 to 8.5 mg/tablet. Furthermore, the patients will receive Cholecalciferol(Vitamin D) Intramuscular injection of 600,000 units of Cholecalciferol for 2 doses given at week 0 and week 4
15723493|NCT05077813|Other|The standard therapy|The standard therapy 100 infected patients with confection of COVID-19 and MDR-TB will receive the standard therapy for tuberculosis for 30 days
15723494|NCT05077800|Drug|FOLFIRNINOX|Combination of 4 different drugs (5-Fluorouracil (5-FU), Oxaliplatin, Irinotecan and Leucovorin) administered by intravenous infusion
15723495|NCT05077800|Drug|Losartan|Taken Orally
15723496|NCT05077800|Drug|9-ING-41|Administered by intravenous infusion
15723497|NCT05077787|Other|Massage therapy|Massage therapy includes stroking, kneading, rolling, tapping, vibration and effleurage over the face, chest ,abdomen and back. Massage therapy will be given for 5 minutes and will be repeated twice.
15723498|NCT05077787|Other|Kinaesthetic stimulation|Kinaesthetic stimulation includes passive flexion and extension movements of shoulder joint, elbow joint, hip joint, knee joint and both lower limbs together. It will be given for 5 minutes in each intervention
15723499|NCT05077774|Device|Harmony TPV System|Harmony Transcatheter Pulmonary Valve (sizes 22 mm and 25 mm) and Harmony Delivery Catheter System (DCS)
15723500|NCT05077761|Device|Active High-intensity laser therapy|"High-intensity laser therapy will be used in the contact method, with the laser beam irradiated over the hamstring muscle. Dosage and parameters for the laser will be calculated.
~Parameters-
~Wavelength- 980 nm
~Intensity/Power density- 3W/cm2
~Emission mode- Continuous Emission
~Energy (Joules)- 490 J
~Irradiation time- 70 Sec on each point
~Peak power- 15 Watt
~Irradiation points- 09"
15723501|NCT05077761|Device|Sham High-intensity laser therapy|Sham High-intensity laser therapy will be used in the contact method, without the laser beam irradiation over the hamstring muscle.
15723502|NCT05077735|Radiation|Hypofractionated Radiation Therapy|Undergo hypofractionated radiation therapy
15723503|NCT05077735|Other|Quality-of-Life Assessment|Ancillary studies
15723504|NCT05077735|Other|Questionnaire Administration|Ancillary studies
15723505|NCT05077722|Device|Garmin|A smartwatch device that measures subjects level of activity, heartrate, respirations and quality of your sleep at night. Artificial intelligence will be applied to analyze all the data over the course of 12 weeks to monitor and attempt to predict the onset of tantrums or disruptive behavior. Subjects are required to wear the watch at least 70% of the day and night each day for 70% of days during 12 weeks of treatment.
15723507|NCT05077696|Other|Drawing a tube of blood (serum)|dosage of neurofilaments and comparison with a final diagnosis one year after sampling.
15723510|NCT05077670|Procedure|Pulmonary vein electrical isolation|Electrical isolation of the pulmonary veins from the left atrium with cryoablation therapy.
15723511|NCT05077670|Device|Atrial substrate mapping|Electro-anatomical maps will be performed with CARTO navigation system with multi-electrode catheters.
15723512|NCT05077657|Device|Early Bird® Bleed Monitoring System|The Early Bird Bleed Monitoring System is used in endovascular procedures to monitor and detect internal bleeding complications in real-time.
15723513|NCT05077657|Device|Impella®|Impella is an FDA-approved percutaneous heart pump indicated for patients with severe coronary artery disease requiring high-risk PCI.
15723514|NCT05077644|Device|Stella (TM) Mobile Application|Treatment of mild-to-moderate postpartum depression (PPD) using Cognitive Behavioral Therapy techniques.
15723515|NCT05077631|Drug|ACD856|Single oral doses of ACD856 administered in a fasted state in escalation schedule of dose 1, dose 2, dose 3, dose 4, dose 5, dose 6 and dose 7. The escalation schedule may be adapted based on evaluation by internal Safety Review Committee.
15723516|NCT05077631|Drug|Placebo|Placebo oral solution
15723517|NCT05077631|Drug|ACD856 (fed cohort)|Single oral dose of ACD856 in fed state of either dose 4 or dose 5.
15723518|NCT05077618|Other|sampling of dental plaque and blood sample during the treatment|sampling of dental plaque and blood sample analysed on day 1
15723520|NCT05077592|Drug|10% Povidone Iodine|Povidone-iodine is a topical antiseptic agent used for the treatment and prevention of infection in wounds.
15723521|NCT05077566|Other|Exercise at 60% vo2|15 minutes of exercise at 60% VO2 max.
15723522|NCT05077566|Other|Exercise at 90% vo2|15 minutes of exercise at 90% VO2 max.
15723523|NCT05077553|Dietary Supplement|TCI999 probiotic sachet|Testing product
15723524|NCT05077553|Dietary Supplement|Placebo sachet|Blank
15723527|NCT05077527|Biological|Axicabtagene Ciloleucel|Given IV
15723528|NCT05077527|Drug|Cyclophosphamide|Given IV
15723529|NCT05077527|Drug|Fludarabine|Given IV
15723757|NCT05075668|Device|High flow nasal cannula (HFNC)|Two types of CPAP therapy for OSA support are compared; CPAP face mask vs HFNC at different flow rates
15723534|NCT05077488|Device|Juvéderm® VOLIFT™ with Lidocaine|Sterile gel in disposable syringe
15723535|NCT05077475|Drug|C52R1H Tab. and C52R2 Tab.|Single oral dose C52R1H(FDC, Valsartan/Amlodipine) 160/10 mg tablet and C52R2(Chlorthalidone) 25 mg tablet taken together
15723536|NCT05077475|Drug|AJU-C52L|Single oral dose AJU-C52(Valsartan/Amlodipine/Chlorthalidone) 80/5/12.5 mg FDC 2 tablet
15723537|NCT05077462|Drug|C52R1M Tab. and C52R2 Tab.|Single oral dose C52R1M(FDC, Valsartan/Amlodipine) 160/5 mg tablet and C52R2(Chlorthalidone) 25 mg tablet taken together
15723538|NCT05077462|Drug|AJU-C52H|Single oral dose AJU-C52(Valsartan/Amlodipine/Chlorthalidone) 160/5/25 mg FDC tablet
15723539|NCT05077449|Drug|XZP-3287+Fulvestrant|XZP-3287 360 mg orally Twice daily(Q12H) of every 28-day cycle Fulvestrant 500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 for every cycle (28-day) until progressive disease
15723540|NCT05077449|Drug|Placebo + Fulvestrant|Placebo 360 mg orally Twice daily(Q12H) of every 28-day cycle Fulvestrant 500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 for every cycle (28-day) until progressive disease
15723541|NCT05077436|Drug|Vamifeport Formulation 1|Vamifeport Formulation 1 is available as 60 mg oral capsules
15723542|NCT05077436|Drug|Vamifeport Formulation 2|Vamifeport Formulation 2 is available as 60 mg oral capsules
15723544|NCT05077397|Device|StO2|InSpectra Tissue Spectrometer Model 1615 probe (Hutchinson Technology Inc. Hutchinson, MN, USA) probes will be placed on the skin area corresponding to the patients' liver lodge prior to induction of anesthesia. In addition, the probes of both devices will be placed in the renal site on the same side. Basal values will be measured with both devices and StO2 values in the devices will be recorded every 15 minutes. Probes will not be removed during surgery and for 24 hours postoperatively.
15723545|NCT05077397|Device|O3|O3TM Regional Oximeter System (O3 System, Masimo Corporation, Irvine, CA) probes will be placed on the skin area corresponding to the patients' liver lodge prior to induction of anesthesia. In addition, the probes of both devices will be placed in the renal site on the same side. Basal values will be measured with both devices will be recorded every 15 minutes. Probes will not be removed during surgery and for 24 hours postoperatively.
15723547|NCT05077371|Behavioral|Peer support program|The intervention will consist of 8 face-to-face peer social support sessions conducted by volunteers diagnosed with breast cancer who have finished their medical treatment (chemotherapy, radiotherapy, surgery) or who have been in a stable phase for at least two years and who are motivated to participate in this type of intervention.
15723548|NCT05077358|Procedure|Intracorporeal anastomosis|In this group, the anastomosis is performed inside the abdominal cavity with a laparoscopic technique. Specimen extraction will be done through Pfannenstiel incision or similar incision in lower abdomen.
15723549|NCT05077358|Procedure|Extracorporeal anastomosis|In this group, the anastomosis is performed by pulling out the bowel through a laparotomy.
15723550|NCT05077332|Drug|Famotidine|80 mg tablet, QID for 14 days
15723551|NCT05077332|Drug|Celecoxib|400 mg (initial dose) then 200 mg capsule, BID for 5 days
15723552|NCT05077332|Other|Placebo|tablet, QID for 14 days; capsule, BID for 5 days
15723553|NCT05077306|Other|music therapy group|individual bedside single session of receptive music therapy (RMT) by a certified Music therapist- GIM fellow in presence. STAI Y-1 was administered 5 min. before session (STAI Y-1 PRE) and 15 min. after session (STAI Y-1 POST) in paper form. HR and O2Sat were recorded from the bedside monitor 3 times: start session (T0), 10 min. (T1), end session (T2).Participants i were asked to fill in an optional open-ended question concerning their experience with music therapy.
15723563|NCT05077241|Device|Inspiratory muscle training|Individuals will be instructed to perform a rapid contraction of the inspiratory muscles against a load and sustain it for 2 seconds in each maneuver.
15723564|NCT05077215|Drug|EG-007|A Repurposed Drug
15723565|NCT05077215|Drug|Pembrolizumab 100 mg/ 4 ml (25 mg/ml) Injection|Pembrolizumab will be provided as a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution that requires dilution for intravenous infusion. Each vial contains 100 mg of pembrolizumab in 4 mL of solution.
15723566|NCT05077215|Drug|Lenvatinib Capsules|Lenvatinib will be provided as 4-mg and 10-mg capsules. Lenvatinib is formulated with calcium carbonate, mannitol, microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, and talc.
15723567|NCT05077202|Device|ultra sound|chest ultrasound
15723640|NCT05076617|Drug|Staccato alprazolam|"Pharmaceutical form: Inhalation powder
~Route of administration: Inhalation
~Participants will receive Staccato alprazolam during the Treatment Period."
15723570|NCT05077137|Biological|Tetanus Diptheria Vaccine|tetanus and diphtheria toxoids
15723571|NCT05077137|Biological|Polio Boost Immunization|trivalent inactivated polio vaccine
15723572|NCT05077124|Device|CytoSorb|Sorbent hemoperfusion system
15723573|NCT05077111|Procedure|Thoracic Epidural Anesthesia|Group A pre-medicated once using Midazolam 3-4mg intravenous (IV) and Fentanyl 50mcg, placed in the setting position. Using a winged 18G (Gadge), 9cm length Tuohy Epidural needle, a 20G springwound closed tip epidural catheter be inserted between T3-T4. A test dose (5ml) 2% Lidocaine given, followed by 5-8 ml Bupivacaine 0.5% and 50mcg Fentanyl as a loading dose. Further top-up dose of 5 ml Bupivicaine 0.5% after 45 minutes.
15723574|NCT05077111|Procedure|General Anesthesia with One Lung Ventilation|Group B premedicated once by 3-4mg Midazolam IV, Ranitidine 50mg, Metoclopramide 10mg and Dexamethasone 4mg. Preoxygenation with 100% O2. Induction of anesthesia with Propofol (2mg/kg) and Fentanyl (1mcg/kg). Tracheal intubation by 37-39 Fr Double Lumen Endotracheal Tube insertion facilitated with Cisatracurium 0.1mg/kg. and confirmation of its position by Fiberoptic Bronchoscopy. Selective Lung Ventilation strategy can be performed through the endobroncheal tube of the non operated lung once needed. Anesthesia maintained with Isoflurane (1-2%) and Cisatracurium (0.05mg/kg per dose). Later, anesthesia discontinued and extubation after full neuromuscular recovery after reversal of muscle relaxant by Neostigmine (0.05mg/kg) and Atropine (0.02mg/kg).
15723575|NCT05077098|Drug|ADXS-504|ADXS-504 will be administered as monotherapy at 2 dose levels. Subjects who are assigned to receive DL1 will be administered ADXS-504 at a dose of 1×107 CFU q4 weeks (±3 days) from Week 1 to Week 21. Subjects who are assigned to receive DL2 will be administered ADXS-504 at a dose of 1×108 CFU q4 weeks (±3 days; Week 1 to Week 21). All 3-6 subjects must be enrolled in DL1, and DL1 must be confirmed safe, before enrollment for DL2 may begin. If DL1 is deemed to exceed the MTD, dose reduction of ADXS-504 to DL-1 (1×106 CFU) may proceed. Dose level -1, intermediate dose levels or expansion of a cohort may also be further evaluated if recommended by the Investigator and Advaxis in future amendments.
15723584|NCT05077046|Other|Ergonomic handwriting pen|An ergonomic handwriting pen called AWP-pen designed to reduce perceived muscle fatigue, finger tip pressure and discomfort during handwriting activities.
15723585|NCT05077033|Drug|phIL12 GET|intratumoral phIL12 gene electrotransfer
15723586|NCT05077007|Procedure|Percutaneous nephrolithotomy|Endoscopic stone Extraction from the kidney by making a puncture and dilate a tract direct into the kidney through muscle wall and renal parenchyma
15723587|NCT05077007|Procedure|Extracorporeal Shock Wave Lithotripsy|Using Shock waves from outside the body targeted at a kidney stone causing the stone to fragment. The stones are broken into tiny pieces.
15723588|NCT05076994|Other|Exercise therapy|A series of home exercise videos to improve patient adherence to exercise prescription
15723589|NCT05076994|Other|Standard Care|An exercise prescription and verbal instructions in clinic
15723590|NCT05076981|Drug|human chorionic gonadotropin|once the dominant follicle reaches 17mm or above, a bolus of 6500 rhCG (Ovitrelle, Merck-Serono) will be administered subcutaneously
15723591|NCT05076968|Procedure|Complete denture fabrication|Patient satisfaction was assessed regarding dentures fabricated by students and specialists after 8 weeks of delivery
15723592|NCT05076955|Drug|vancomycin-tobramycin-itraconazole|Participants with diabetic foot ulcers will be treated with a compounded, anti-infective irrigation therapy daily until closure of the ulcer or up to a maximum of 3 months. This is an irrigating foot bath with a compounded medication of vancomycin-tobramycin-itraconazole. This medication with combined 3/4 gallon of water. Participant will soak foot in solution for 10 minutes per day. Daily until wound is healed for a minimum of 4 weeks and a maximum of 3 months.
15723593|NCT05076942|Radiation|Radiotherapy combined with cisplatin|Inguinofemoral radiotherapy combined with weekly cisplatin
15723594|NCT05076942|Drug|Cisplatin|Inguinofemoral radiotherapy combined with weekly cisplatin
15723595|NCT05076929|Diagnostic Test|ultrasound|Ultrasonographic measurement of Inferior Vena Cava Collapsibility Index
15723596|NCT05076916|Behavioral|The effectiveness of the web-based education programme among cancer patients|The web-based education program was introduced to the patients with cancer in the intervention group during face-to-face interviews. They were asked to examine the program for at least two hours a week for three months. During the follow-up period, the patients in the intervention group were called twice a week and reminded to use the education program. The researchers get in contact with the patients online via the website. The patients contact the research team by calling or writing messages via the website 24/7. An e-mail account was created by the research team using the email system of the university, and it was shared with the patients. The clinical researchers of the team answered the patients' questions via this e-mail account.
15723597|NCT05076903|Drug|OFA|Dexmedetomidine and lidocaine are administered during anesthesia, and opioid is not used. For induction, 1 μg/kg of Dexmedetomidine is administered over 10 minutes and 1mg/kg of lidocaine is administered intavenously (bolus). This is followed by continuous intravenous infusion of dexmedetomidine at a rate of 0.2-0.7 μg/kg/h and infusion of lidocaine at the rate of 1 mg/kg/h.
15723689|NCT05076149|Drug|VX-121/TEZ/D-IVA|Fixed-dose combination tablets for oral administration.
15723690|NCT05076149|Drug|ELX/TEZ/IVA|Fixed-dose combination tablets for oral administration.
15794004|NCT04500665|Drug|Placebo|Placebo
15723598|NCT05076903|Drug|Control|Remifentanil is infused during anesthesia, and target-controlled infusion (TCI) is performed according to the Minto model. During indcution of anestheisa, target concentration of remifentanil is set within 3-5 ng/mL. After intubation, target concentration is adjusted within the range of 2-8 ng/mL.
15723599|NCT05076890|Dietary Supplement|15 mg/g Full Spectrum Hemp Extract|HPMC capsules containing full spectrum standardized hemp extract in liquid form.
15723600|NCT05076890|Dietary Supplement|50 mg/g Full Spectrum Hemp Extract|HPMC capsules containing full spectrum standardized hemp extract in liquid form.
15723601|NCT05076877|Drug|Lazertinib|Lazertinib tablets will be administered orally, alone or in combination with probe substrates.
15723602|NCT05076877|Drug|Midazolam|Midazolam (cytochrome P450 3A4 [CYP3A4] substrate) will be administered orally as a syrup as a part of probe substrates.
15723603|NCT05076877|Drug|Rosuvastatin|Rosuvastatin (breast cancer resistant protein [BCRP] substrate) tablet will be administered orally as a part of probe substrates.
15723604|NCT05076877|Drug|Metformin|Metformin (organic cation transporter 1 [OCT1] substrate) will be administered orally as a syrup as a part of probe substrates.
15723605|NCT05076864|Other|No intervention|No intervention
15723606|NCT05076851|Other|placebo|placebo+ADT（Androgen Deprivation Therapy） ，Route of placebo administration: tablet, dosage：300mg , dosage form oral , frequency of administration：QD
15723607|NCT05076851|Drug|Proxalutamide|Proxalutamide +ADT（Androgen Deprivation Therapy） ，Route of Proxalutamide administration: tablet, dosage：300mg , dosage form oral , frequency of administration：QD
15723608|NCT05076838|Drug|Diazepam Nasal Spray [Valtoco]|5 mg, 10 mg, or 15 mg dose of intranasal VALTOCO will be administered based on the subject's body weight.
15723609|NCT05076825|Other|Neurodynamic Sliding|Participants supine with their cervical and thoracic spine supported in a forward flexed position. Simultaneous hip and knee flexion will be alternated dynamically with simultaneous hip and knee extension. The therapist will change the arrangement of movement depending on the tissue resistance level.
15723610|NCT05076825|Other|Static Stretching|Participent lying supine, the therapist will passively position the subject into the straight leg raise position without discomfort or pain to the point where resistance to movement will be first felt.
15723612|NCT05076799|Drug|100 ml lactulose combined with 1 L PEG|the participants were instructed to consume 100 ml lactulose combined with 1000 mL of PEG solution
15723613|NCT05076799|Drug|100 ml lactulose combined with 2 L PEG|the participants were instructed to consume 100 ml lactulose combined with 2000 mL of PEG solution
15723614|NCT05076799|Drug|200 ml lactulose|the participants were instructed to consume 200 ml lactulose alone
15723615|NCT05076799|Drug|3 L Polyethylene glycol solution|the participants were instructed to consume 3000 mL of PEG solution
15723616|NCT05076786|Drug|Chidamide|20mg, administered orally. Week 1/2: twice a week (d0, d4, d7, d11); Week 3: stop. Repeat every 3 weeks for 4-6 cycles.
15723617|NCT05076786|Drug|Etoposide + Cisplatin/Carboplatin|"Etoposide (100mg/m2; intravenous infusion; d1-3) + Cisplatin (75mg/m2; intravenous infusion; d1). Repeat every 3 weeks for 4-6 cycles.
~OR Etoposide (100mg/m2; intravenous infusion; d1-3) + Cisplatin (25mg/m2; intravenous infusion; d1-3). Repeat every 3 weeks for 4-6 cycles.
~OR Etoposide (100mg/m2; intravenous infusion; d1-3) + Carboplatin (AUC=5; intravenous infusion; d1). Repeat every 3 weeks for 4-6 cycles."
15723618|NCT05076773|Procedure|Ultrasound guided block|Giving one regional block
15723619|NCT05076773|Drug|IV morphine|given when VAS>3
15723620|NCT05076760|Biological|MEM-288 Intratumoral Injection|Intratumoral injection of MEM-288, conditionally replicative oncolytic adenovirus vector encoding transgenes for human interferon beta (IFNβ) and a recombinant chimeric form of CD40-ligand (MEM40).
15723621|NCT05076747|Behavioral|Cardiovascular training|8 weeks of cardiovascular training
15723622|NCT05076747|Behavioral|Standard Therapy|8 weeks of Standard Therapy
15723623|NCT05076734|Diagnostic Test|Redraw for analysis of blood samples from healthy pregnant women|If less than two fetal cells are recovered from maternal blood, a redraw is indicated
15723624|NCT05076721|Other|Simulation training|The participants in the simulation group will receive simulation training with high-fidelity manikin to practice and implement one-hour bundle sepsis
15723625|NCT05076721|Other|Case-based discussion training|The participants in the conventional group will only do a case-based discussion in implementing one-hour bundle sepsis
15723627|NCT05076695|Drug|Palbociclib|Palbociclib will be given at the dose of 125 mg po q.d. x 21 every 4 weeks (i.e. 1 week rest period for a total of 5 cycles)
15723628|NCT05076695|Drug|trastuzumab|8 mg/kg loading dose IV, then 6 mg/kg IV, every 3 weeks for a total of 6 administrations.
15723629|NCT05076695|Drug|pyrotinib|Pyrotinib 400mg, PO daily, continuously
15723630|NCT05076695|Drug|fulvestrant|Fulvestrant will be administered according to local prescription guidelines and will be given intramuscle at the dose of 500 mg every 4 weeks (repeat for 5 times) with an additional 500 mg dose given two weeks after the initial dose.
15723631|NCT05076682|Drug|choline|choline 300mg tid or 500mg bid, p.o
15723632|NCT05076682|Drug|PD-1 inhibitor and chemo|PD-1antibody SHR1210 200mg q2w chemo (same regimen in previous treatment)
15723633|NCT05076682|Drug|Sodium Cromoglicate|Sodium Cromoglicate 200mg qid, p.o
15723634|NCT05076669|Other|stoma follow-up|delivery and enhanced follow-up by the FSK HHN provided, in particular, by stomal therapy nurse consultants and patient-relation experts during in-person or remote appointments in addition to the routine care delivered and prescribed by the sites
15723635|NCT05076669|Other|standard of care|routine management of stoma
15723636|NCT05076656|Dietary Supplement|Lactobacillus fermentum D3|Lactobacillus fermentum D3 in a white, gelatin capsule (orally), with lyophilized L. fermentum D3 without preservatives, sugars, or additives.
15723637|NCT05076656|Biological|Fecal microbiota transplant (FMT)|Fecal microbiota transplant (FMT) in a green, gelatin capsule (orally), with lyophilized fecal material.
15723638|NCT05076656|Drug|Placebo|Placebo in a white, gelatin capsule (orally), with powder milk
15723639|NCT05076630|Other|Air pollutants|Particulate matter and gaseous pollutants
15723641|NCT05076604|Drug|Cardioplegia Solution|"The microplegia solution that is standard of care for all cardiac surgery patients, and which all study subjects will receive is:
~Induction 240 mL Baxter Cardioplegia Solution 10. 5 mL Potassium Chloride 2 meq/ml (21 meq) 250.5 mL total volume
~Maintenance 747 mL Baxter Cardioplegia Solution 3.4 mL Potassium Chloride 2 meq/ml (6.75 meq) 750.4 mL total volume
~Subjects will be randomly assigned to 4:1 cardioplegia or nondiluted microplegia.
~4:1 cardioplegia consists of 4 parts crystalloid intravenous fluid to one part human blood.
~Nondiluted microplegia consists of all parts human blood."
15723642|NCT05076604|Drug|Microplegic Solution No. 1|"The microplegia solution that is standard of care for all cardiac surgery patients, and which all study subjects will receive is:
~Induction 240 mL Baxter Cardioplegia Solution 10. 5 mL Potassium Chloride 2 meq/ml (21 meq) 250.5 mL total volume
~Maintenance 747 mL Baxter Cardioplegia Solution 3.4 mL Potassium Chloride 2 meq/ml (6.75 meq) 750.4 mL total volume
~Subjects will be randomly assigned to 4:1 cardioplegia or nondiluted microplegia.
~4:1 cardioplegia consists of 4 parts crystalloid intravenous fluid to one part human blood.
~Nondiluted microplegia consists of all parts human blood."
15723643|NCT05076591|Drug|IMM2902|a recombinant bispecific monoclonal antibody with high affinity to the dual targets, HER2 and CD47
15723644|NCT05076578|Device|Autologous Regeneration of Tissue (ARTTM) system|The ART Skin Harvesting System is intended to harvest full thickness skin microcolumns in a minimally invasive manner and scatter them at the recipient site. It consists of three components: (1) a non-sterile, reusable handheld device; (2) a sterile, single-patient use needle cartridge containing the needle array for harvesting skin micrografts from the patient donor site; and (3) a sterile, disposable handheld protective sleeve to cover the handheld device (figure 1). The sterile sleeve reduces contamination of the reusable handheld device and provides a sterile barrier between the non-sterile handheld device and the patient.
15723645|NCT05076565|Device|Airbag Belt Fall Protection System|Both versions of Airbags features different number of IMU sensors. Participant's will be randomly assigned one of the two versions. The algorithms developed in this project will help the researcher to identify the optimal performance (sensitivity and specificity values for detecting falls). Based on this information the research team will be able to choose a version for home/community deployment portion of the study. Based on the performance of the airbags in detecting true positives (falls) and true negatives (non-falls) accurately one of the airbags will be used in community deployment phase of the study.
15723646|NCT05076552|Drug|TACH101|Orally via capsules
15723647|NCT05076539|Other|Garmin GPS activity tracker|50 patients will be issued a Garmin GPS-activity tracker where they will be required to wear for 24 hours for 1 week, prior to each timepoint (pre-operatively and 6 months post surgery).
15723648|NCT05076526|Biological|Hyaluronic acid (Synolis VA)|"Synolis VA harbours the following characteristics:
~NaHA (Sodium hyaluronate): 20mg/mL, biofermantative and pharmaceutical grade origin.
~Sorbitol: 40mg/mL
~Molecular weight of 2MDa, sterilized in moist heat"
15723649|NCT05076526|Biological|Cellular Matrix platelet-rich-plasma with hyaluronic acid (CM PRP-HA)|"The CM-PRP-HA tube is under vacuum containing the following:
~2mL of hyaluronic acid gel in phosphate buffer (Sodium chloride, Dipotassium hydrogenphosphate, Potassium dihydrogenphosphate, Potassium chloride and water for injection). Not crosslinked Hyaluronic Acid (40mg per tube) is obtained from fermentation
~3g of inert cell-selector gel
~0.6mL of anticoagulant (sodium citrate 4%)"
15723650|NCT05076513|Drug|Niraparib|"In Phase 0, 300mg administered orally QD for 4 days prior to resection.
~In the Expansion cohort/Maintenance phase, niraparib will be administered as described below:
~For patients weighing <77 kg (<170 lbs) OR with a platelet count <150,000/mcL, the recommended dosage is 200 mg taken orally once daily.
~For patients weighing ≥77 kg (≥170 lbs) AND a platelet count ≥150,000/ mcL, the recommended dosage is 300 mg taken orally once daily."
15723651|NCT05076513|Radiation|Radiation therapy|Participants in Arm A who move onto the Expansion cohort will receive 6-7 weeks of radiation therapy per standard of care.
15723652|NCT05076500|Procedure|Biopsy and blood sample collection|"A pre-treatment diagnostic biopsy sample plus 1 mandatory biopsy (during/post-radiotherapy [irradiated site]) will be collected from each participant.
~Matched blood samples will be collected from participants at baseline, during/post-radiotherapy, and if radiotherapy continues after the on-treatment biopsy is taken, an additional end of treatment blood sample will be collected."
15723653|NCT05076474|Drug|Orlistat 60mg Cap|Subjects completed a 5-day run-in period (baseline) and then were randomized to receive the first of 3 treatments; each treatment period lasted 10 days followed by a 4-day washout period between treatments.
15723654|NCT05076461|Drug|Ondansetron|Ondansetron group received oral suspension of ondansetron as 0.15mg per body weight
15723691|NCT05076149|Drug|IVA|Tablet for oral administration.
15723692|NCT05076149|Drug|Placebo (matched to VX-121/TEZ/D-IVA)|Placebo matched to VX-121/TEZ/D-IVA for oral administration.
15723693|NCT05076149|Drug|Placebo (matched to ELX/TEZ/IVA)|Placebo matched to ELX/TEZ/IVA for oral administration.
15723658|NCT05076435|Drug|Isotonic crystalloids|"Types of fluids in both intervention groups:
~Fluids used for electrolyte disturbances: Fluids should be chosen to substitute the specific deficiency
~Fluids given to substitute overt loss: Isotonic crystalloids are to be used. If large amounts of ascites are tapped, then human albumin may be used.
~Blood products are only to be used on specific indications including severe bleeding, severe anaemia and prophylactic in case of severe coagulopathy."
15723664|NCT05076383|Other|Study Group (Motor relearning program)|Task-specific training based on motor relearning program will be performed for 8 weeks (3 sessions per week; 1 hr. per session; total 24 sessions). Each training session will consist of five training tasks: (1) bed mobility and sitting up over the side of the bed; (2) balanced sitting; (3) standing up and sitting down; (4) balanced standing; and (5) practice of walking.
15723665|NCT05076383|Other|Control Group (Conventional physical therapy program)|The conventional physical therapy program (CPT) exercises will be performed following a standard stroke rehabilitation program for 8 weeks (3 sessions per week; 1 hr. per session; total 24 sessions). Each CPT rehabilitation session will include the following exercises: (1) passive and active-assisted range of motion; (2) stretching; (3) strengthening exercises; (4) balance exercises; and (5) walking.
15723666|NCT05076370|Drug|CBD Day 1|CBD 400mg
15723667|NCT05076370|Drug|CBD Day 2|CBD 800mg
15723668|NCT05076370|Drug|CBD Day 3|CBD 1200mg
15723669|NCT05076357|Behavioral|Caloric Restriction|-30% of participants total energy requirements
15723670|NCT05076357|Other|Cold intervention|Sessions of 90min each every 2nd day involving cold exposure
15723671|NCT05076331|Diagnostic Test|PI-2620 tracer for Tau PET scan|Tau PET scans are obtained using PI-2620 tracer provided by Life Medical Imaging.
15723672|NCT05076318|Other|Aminoacid, alanine-infusion|During 3 hours, patient will receive alanine-infusion, while amino-acid and urea will be monitored by blood samples.
15723673|NCT05076305|Other|No specific intervention; cases are retrospective and patients have already been treated.|To assess the geographic variation that exists in the management of locally advanced and recurrent rectal cancers.
15723674|NCT05076292|Drug|GlucaGen|150 ug or 75*2 ug glucagon will be administered subcutaneously to the participants before and after exercise.
15723675|NCT05076292|Drug|Saline|Saline will be used as placebo before and after exercise.
15723676|NCT05076279|Procedure|Single port or reduced ports laparoscopic distal gastrectomy and D2 lymph node dissection|Single port or reduced ports laparoscopic distal gastrectomy and D2 lymph node dissection
15723677|NCT05076266|Other|Questionnaire|Complete the survey questions
15723678|NCT05076253|Drug|Ivermectin|Ivermectin plus standard care
15723679|NCT05076253|Drug|Placebo|Standard care
15723680|NCT05076240|Procedure|FilmArray® analysis|FilmArray® multiplex PCR analysis to diagnose ventilator associated pneumonia in COVID-19 ARDS
15723681|NCT05076227|Drug|IM injection of vaccination (mRNA vaccination)|mRNA vaccination
15723682|NCT05076227|Drug|IM injection of vaccination (vector based vaccination)|vector based vaccination
15723685|NCT05076201|Behavioral|Patients with completed rehab|The main objective is to measure the level of cocaine craving, 6 months after the end of their detoxification treatment (outpatient or full hospitalization), in patients with a diagnosis of moderate to severe dependence (DSM 5) to cocaine and co-addiction, or not, to alcohol and / or psychostimulants. To evaluate cocaïne craving,the questionnaire CCQ-Brief will be used.
15723686|NCT05076188|Diagnostic Test|Emergency radiography|The intervention is to determine how the radiographer classify emergency radiography.
15723687|NCT05076175|Drug|Ozanimod|Specified dose on specified days
15723688|NCT05076162|Diagnostic Test|PAED|Delirium positive or negative
15724268|NCT05071183|Drug|TPX-0005|Oral TPX-0005 capsules
15723695|NCT05076136|Other|Regional treatment|In reginal treatment patients were given physiotherapy exercises and manual therapies on hip joint as well as on surrounding areas of hip joint such as lumber area and sacroiliac joint.
15723696|NCT05076136|Other|Standard physiotherapy treatment|In this treatment patients were given just hip joint mobilizations and quadriceps and hamstrings stretching.
15723697|NCT05076123|Other|Modified Constraint Induced Therapy and Threshold Electrical Stimulation|M-CIMT emphasizes massed practice with the affected upper limb with restraining unaffected limb by a mitt. Threshold electrical stimulation is based on low-intensity (<100 Hz) and long-duration current and is applied with superficial electrodes.
15723698|NCT05076110|Drug|Oxycodone|5 mg tablets every 4 hours postoperatively as needed for pain control
15723699|NCT05076110|Drug|Ibuprofen|800 mg three times a day for 2 weeks postoperatively for pain control; not to exceed 3200 mg/day
15723700|NCT05076110|Drug|Gabapentin|300 mg three times a day for 5 days then wean off by day 10 postoperatively
15723701|NCT05076110|Drug|Acetaminophen|1000 mg three times a day for up to 4 weeks postoperatively for pain control; not to exceed 4 grams per day
15723702|NCT05076110|Drug|Methocarbamol|500 mg three times a week for 2 weeks postoperatively
15723703|NCT05076097|Drug|Orelabrutinib in in combination of rituximab and lenalidomide(OLR)|Induction treatment phase: Orelabrutinib: 150mg QD D1-28; Lenalidomide: Cycle 1: 15mg QD D1-21, if no dose-limiting toxicity occurred in Cycle 1, cycle 2-6: 20mg QD D1-21; Cycle 1: 375 mg/m2 d1, 8,15,22; Cycle 3, 5: 375 mg/m2 D1 Maintenance treatment phase: Orelabrutinib: 150mg QD D1-28; Lenalidomide: cycle 7-24: 15mg QD D1-21; Cycle 7, 9, 11, 13, 15, 17, 19, 21, 23: 375 mg/m2 D1. 28 days for a cycle.
15723706|NCT05076071|Genetic|NGS|Next Generation Sequencing
15723707|NCT05076058|Dietary Supplement|Tablet of silybum marianum, Pueraria lobate and salvia miltiorrhiza|"Brand names: BY-HEALTH；
~Main contents (per 100g): silibinin 2g, salvianolic acid B 0.72g，Puerarin 0.68g"
15723708|NCT05076058|Other|Placebo tablet|"Brand names: BY-HEALTH；
~Main contents : starch"
15723709|NCT05076045|Device|Personal sound amplification products|Participants will be tested with bilateral personal sound amplification products.
15723710|NCT05076032|Drug|OXO-001|OXO-001 oral administration once daily in the early morning. The treatment duration will vary depending on the woman, but it will last between 10 to 14 weeks approximately.
15723711|NCT05076032|Drug|Placebo|Placebo oral administration once daily in the early morning. The treatment duration will vary depending on the woman, but it will last between 10 to 14 weeks, approximately.
15723712|NCT05076019|Drug|Atorvastatin 80mg|Dosage: 80 mg Form: Tablets Frequency: 1 tabl. per day. Duration: From 7 to 14 days prior to surgery until 30 days postoperative
15723713|NCT05076019|Drug|Placebo|Form: Tablets Frequency: 1 tabl. per day. Duration: From 7 to 14 days prior to surgery until 30 days postoperative
15723714|NCT05076006|Drug|PF-06700841|Active study drug
15723715|NCT05076006|Drug|Placebo|placebo comparator
15723716|NCT05075993|Drug|LVGN3616 + LVGN6051 + Nab-Paclitaxel|Given by IV, Given by PO
15723717|NCT05075993|Drug|LVGN3616 + LVGN6051 + Bevacizumab + Cyclophosphamide|Given by IV, Given by PO
15723718|NCT05075993|Drug|LVGN3616 + LVGN6051 + LVGN7409 + Nab-Paclitaxel|Given by IV, Given by PO
15723719|NCT05075993|Drug|LVGN3616 + LVGN6051 + LVGN7409 + Bevacizumab + Cyclophosphamide|Given by IV, Given by PO
15723720|NCT05075980|Drug|Cisplatin|Given IV
15723721|NCT05075980|Procedure|Intensity-Modulated Proton Therapy|Undergo IMPT
15723722|NCT05075980|Other|Quality-of-Life Assessment|Ancillary studies
15723723|NCT05075980|Other|Questionnaire Administration|Ancillary studies
15723724|NCT05075967|Other|Health Equity|This community-level structural component will use a standardized, nationally replicable community coalition model (Black Treatment Advocates Networks [BTAN]) to implement an enhanced program model geared to 1) facilitate the effects of the other HPTN 096 interventions by minimizing barriers to HIV testing, PrEP use and viral suppression through sensitizing a local network of service providers (e.g., social, legal, economic sectors) to the needs of Black MSM and maintaining an online platform for exchanging information about the local network that can be used to link Black MSM to resources and services, and 2) amplify the effects of other HPTN 096 components by increasing Black MSM's receptivity to those activities through the integration and promotion of HPTN 096 into the activities of the community coalition model.
15723725|NCT05075967|Behavioral|Social Media Influencers|"In this community-level component, social media influencers (SMI) will be defined for the purposes of this study as users on social media who have established credibility, trust and access to a large audience of Black MSM, and who can persuade them by virtue of their authenticity and reach. SMI will provide tailored messaging for Black MSM in intervention communities on the topics of:
~HIV/sexually transmitted infections (STI) testing promotion
~PrEP (and general HIV prevention) awareness and promotion
~Definition and benefits of viral suppression.
~Messages may include direction towards health care facilities (HCFs) involved in the intersectional stigma reduction component and information about the virtual peer support platform or BTAN+ events."
15723726|NCT05075967|Behavioral|Intersectional Stigma Reduction|This organizational-level component will take place in HCFs and is designed to improve cultural responsiveness in the provision of HIV prevention and health care services to Black MSM. It is expected to contribute to a reduction in HIV incidence by creating an affirming and autonomy-supportive healthcare environment that supports Black MSM engagement in HIV-related care and services and that promotes increased HIV/STI testing, PrEP uptake and viral suppression rates.
15723758|NCT05075655|Device|Endobronchial ultrasound guided miniforceps biopsy and transbronchial needle aspiration|"Mediastinal node is sampled using three path of classic ultrasound guided transbronchial needle aspiration (EBUS-TBNA).
~A reduce size forceps is then inserted inside the mediastinal node via the duc EBUS-TBNA made and biopsies (EBUS-MFB) are made using real time ultrasound guidance."
15723759|NCT05075642|Other|Initial management of the urinary disorder/s identified during the screening phase|Intervention can be defined as the initial management of the LUTS identified during the screening phase; management lasts at least three months. As observation of routine clinical practice, no specific intervention is included, but any counseling/drug/rehabilitation included as first line management.
15723727|NCT05075967|Behavioral|Peer Support|"Peer support workers will be trained and compensated to provide emotional and practical support services. These peer support workers will have shared lived experiences with those whom they are supporting, be self-reflective of those experiences, and know when to share those experiences with others in an appropriate and supportive manner. Once trained, the peer-support workers will have demonstrated competencies in the following domains:
~HIV, PrEP, nPEP, other HIV prevention options and ART education
~Adherence to PrEP, ART and medical care
~HIV/STI testing
~New HIV diagnosis
~Addressing intersectional stigma (anti-Black racism, sexual stigmas, HIV-related stigma)
~Self-care
~Information about national and local resources and assistance programs, Black MSM-centered health services, and the cost and insurance coverage of medications and medical care
~Multicultural competency (as it relates to the HIV epidemic for Black MSM in the southern US)"
15723728|NCT05075967|Other|Standard-of-care|Black MSM living in standard-of-care communities will have access to standard HIV prevention and care services available in their communities.
15723730|NCT05075902|Behavioral|Aerobic training|The program consists of aerobic exercise performed three times a week on non-consecutive days for 12 weeks at an intensity of 65% to 75% of the reserve heart rate. During the first 4 weeks of training, the exercise duration was 40 minutes (5' warm up + 30 minutes in the intensity zone + 5' cool down). From the fifth week onwards, there was only an increase in volume to 50 minutes in duration (5'warm-up + 40 minutes in the intensity zone + 5'warm-up). The aerobic fitness assessment was performed on a maximal effort ergospirometric treadmill under the supervision of a qualified physician, using the Bruce protocol (adapted) to assess cardiopulmonary capacity (to assess possible cardiovascular capacity that prevents the proposed training) and for individualized training prescription.
15723731|NCT05075889|Drug|Indocyanine Green|Enrolled subjects will receive Indocyanine Green administered the day prior to surgery during their standard-of-care preoperative appointment
15723734|NCT05075863|Drug|Letrozole|Letrozole as 5mg from day 3 to 7 of menstrual cycle
15723735|NCT05075850|Device|Neuroblate System|"All subjects will undergo comprehensive neuropsychological assessment post-LITT per standard of care practice.
~Visual field testing will be conducted in a subset of enrolled patients."
15723736|NCT05075837|Biological|Virus -specific T cells|The product is obtained by leukapheresis of a family donor responsive to the virus: consists of virus- specific T lymphocytes (both CD4+ and CD8+) resuspended in PBS / EDTA buffer plus 0.5% Albumin Human. The productive process lasts two consecutive days and includes two phases: a brief activation with specific viral peptide followed by immunomagnetic separation using the CliniMACS® CCS (IFNγ) capture system which allows a fast and automated separation of IFNγ secreting lymphocytes
15723737|NCT05075824|Drug|Crovalimab|Crovalimab will be administered at a dose of 1000 mg IV (for participants with body weight between 40 kg and 100 kg) or 1500 mg IV (for participants with body weight >= 100 kg) on Week 1 Day 1. On Week 1 Day 2 and on Weeks 2, 3 and 4, crovalimab will be administered at a dose of 340 mg SC. For Week 5 and Q4W thereafter, crovalimab will be administered at a dose of 680 mg SC (for participants with body weight between 40 kg and 100 kg) or 1020 mg SC (for participants with body weight >= 100 kg). Dosing schedule will be as per Arm Description.
15723738|NCT05075824|Drug|Placebo|Matching Placebo will be administered with the same dosing schedule and equivalent IV and SC volume as weight-based Crovalimab.
15723739|NCT05075811|Drug|Ossium vBM-MSC|Vertebral bone marrow derived mesenchymal stem cells
15723740|NCT05075811|Other|Placebo|Normal Saline
15723742|NCT05075772|Drug|BI 765080|BI 765080
15723749|NCT05075733|Other|Survey|Survey was sent to all the Americas Hepato-Pancreato-Biliary Association's members
15723750|NCT05075720|Dietary Supplement|Meat with added nitrate|Prosciutto/pancetta/Parma ham/salami (all derived from pork) prepared by a commercial butcher with sodium nitrate and nitrite as an additive.
15723751|NCT05075720|Dietary Supplement|Meat without added nitrate|Pork sausages, prepared by a commercial butcher, equivalent in weight to the meat plus nitrate intervention. Nitrate is not an allowed additive in sausages.
15723752|NCT05075707|Other|Electromagnetic therapy.|Electromagnetic therapy will be applied for 20 min/ session for (3 days/ week for two months) to the group intervention.
15723753|NCT05075707|Other|Low level laser therapy (LLLT)|Low level laser therapy (LLLT) will be applied for 20 min/session laser scanner for three days each week for two months to the group intervention.
15723755|NCT05075681|Drug|Modified By/Cy conditioning regimen intensified by Ruxolitinib and Chidamide|"Drug: modified By/Cy conditioning regimen intensified by Ruxolitinib and Chidamide.
~Day -15 # Ruxolitinib 70mg bid, Chidamide 30 mg once; Day -14 # Ruxolitinib 70mg bid; Day -13 # Ruxolitinib 70mg bid; Day -12 # Ruxolitinib 70mg bid, Chidamide 30 mg once; Day -11 # Ruxolitinib 70mg bid; Day-10# Cytarabine 4g/m2/day CI (only for Haploidentical and unrelated donor), Ruxolitinib 60mg bid; Day- 9# Cytarabine 4g/m2/day CI, Ruxolitinib 60mg bid; Day- 8 # Busulfan 0.8mg/ kg Q6h iv, Ruxolitinib 50mg bid, Chidamide 30 mg once; Day- 7# Busulfan 0.8mg/ kg Q6h iv, Ruxolitinib 50mg bid; Day-6# Busulfan 0.8mg/kg Q6h iv, Ruxolitinib 40mg bid; Day-5# Cyclophosphamide 1.8 g/m2/day CI, Ruxolitinib 30mg bid, Chidamide 30 mg once; Day-4# Cyclophosphamide 1.8 g/m2/day CI,Ruxolitinib 20mg bid; Day-3# Carmustine 250mg/m2/ day iv, Ruxolitinib 10mg bid; Day-2# Ruxolitinib 5mg bid, Chidamide 30 mg/day; Day-1# Ruxolitinib 5mg qd;"
15723756|NCT05075668|Device|CPAP face mask|Two types of CPAP therapy for OSA support are compared; CPAP face mask vs HFNC at different flow rates
15796977|NCT04476303|Drug|BEY2153|Capsule
15723760|NCT05075616|Procedure|Percutaneous endoscopic gastrostomy|Percutaneous endoscopic gastrostomy (PEG) is a minimally-invasive endoscopic procedure that creates a passage from the patient's stomach to the abdominal wall via a feeding tube and provides a means of feeding if oral intake is not adequate.
15723762|NCT05075590|Diagnostic Test|Coronary Angiography|Following TAVR, the operators will attempt to selectively engage both the right and left coronary arteries. Catheter choice and engagement technique will be at the discretion of the operator.
15723765|NCT05075564|Drug|Part 1 ES002023|ES002023 is administered via intravenous infusion, once every 14 days, every 28 days as a treatment cycle for a maximum treatment duration per patient of 2 years.
15723766|NCT05075564|Drug|Part 2 ES002023|ES002023 is administered via intravenous infusion, once every 14 days, every 28 days as a treatment cycle for a maximum treatment duration per patient of 2 years.
15723770|NCT05075538|Biological|Spikevax|Third dose as per national guidelines
15723771|NCT05075525|Other|High Intensity Laser Therapy Group|High Intensity Laser Therapy (HILT) and exercises will be used.
15723772|NCT05075525|Other|Ultrasound and Transcutaneous Electrical Nerve Stimulation Group|Transcutaneous electrical nerve stimulation(TENS), ultrasound (US) will be applied.
15723773|NCT05075525|Other|Ultrasound and Interferential Current Stimulation Group|Ultrasound (US) ,interferential current stimulation and exercise will be used.
15723774|NCT05075512|Drug|anlotinib, fulvestrant|anlotinib: 12 mg once daily on days 1-14, repeated every 21 days; fulvestrant: 500 mg on days 1 and 15 of cycle one, and then on day one of each subsequent 28 days cycle
15723775|NCT05075499|Biological|COVID-19 vaccination|Blood sample obtained before, 1 , 3 and 6 months after the intervention
15723776|NCT05075486|Behavioral|Collaborative quality improvement|Hospitals will receive standardized center-specific ECLS data report with benchmarking to feedback on their performance. Evidence-based potential better practice list will be established as a reference for all hospitals. During the intervention period, the hospitals will receive training in collaborative quality improvement method and then develop, implement, and document evidence-based practice changes to reduce adverse outcomes of neonatal ECLS treatment. Compliance with practice changes and neonatal outcomes will be monitored. All hospitals will have access to implementation support and collaborative activities.
15723777|NCT05075473|Other|Segmental stabilization|Physiotherapist will perform activation of multifidus in prone position. It also includes activation of transverse abdominas in crook lying position, in sitting as well as in point kneeling position to re-establish simultaneous contraction of deep muscles synergy.
15723778|NCT05075473|Other|Generalized Lumber stabilization exercsies|It can by performed by patient him or her self under physiotherapist's assistance. Lumber neutral position is maintained. Bridging in prone as well as supine position will be maintained.
15723779|NCT05075460|Drug|Tucidinostat, Azacitidine combined with CHOP|"Azacitidine: 200 mg D1200 mg D2100 mg D3 subcutaneous injection Tucidinostat: 20mg / time, D1, 4, 8, 11; Take medicine with 200ml warm boiled water 30 minutes after breakfast.
~CHOP chemotherapy:
~Cyclophosphamide (CTX) 750mg / m2 intravenous infusion, day 1;
~Epirubicin (EPI) 70mg / m2 intravenous infusion, day 1;
~Vinoresin (VDS) 4mg intravenous infusion, day 1;
~Prednisone 100mg orally, day 1-5. Every 21 days is a course of treatment"
15723780|NCT05075447|Behavioral|Emotion Control Treatment Program|Intervention programs include Child Training and Training in real scenes
15723781|NCT05075434|Other|Conventional Treatment|This protocol will be the one prescribed by the health centre. It consists of calf stretching exercises, plantar fascia, proprioceptive exercises, ultrasound, magnetic therapy and gait re-education and proprioceptive exercises for 40-45 minutes. Participants will receive 8 treatment sessions spread over 4 weeks (2 sessions per week).
15723782|NCT05075434|Other|Diacutaneous fibrolysis|"15 minutes of the treatment technique. The FD intervention will be carried out with the same duration and protocol for all participants.
~The intervention protocol will be: Start with the point of maximum tension between the two muscle bellies of the calf and hamstring (reverse hook). Then work on the peroneus longus lateralis and soleus. Then the external calf muscle belly and soleus and the internal calf muscle belly and soleus. Then work on the tendon of the flexor hallucis proprio of the big toe and the inner edge of the Achilles tendon and peroneus longus. Then treatment of the peroneus longus with the peroneus brevis. Scraping of the insertion of the Achilles tendon, hooking of the internal and external part of the plantar fascia. Finally, longitudinal friction of the plantar fascia."
15723783|NCT05075421|Procedure|Gastrectomy|Any type of gastrectomy for gastric cancer
15723784|NCT05075408|Drug|Nemolizumab|Participants will receive 2 subcutaneous injection of 30 milligram (mg) of nemolizumab or placebo every 4 weeks (Q4W), with a loading dose of 60 mg at Baseline for period of 12 weeks with an 8 week follow-up.
15723785|NCT05075408|Drug|Nemolizumab|Participants will receive 2 subcutaneous injection of 30 mg of nemolizumab or placebo every 4 weeks (Q4W), with a loading dose of 60 mg at Baseline for a period of 12 weeks with an 8 week follow-up.
15723786|NCT05075408|Drug|Placebo|Participants will receive 2 subcutaneous injection of 30 mg of placebo-matched to nemolizumab Q4W for period of 12 weeks.
15723787|NCT05075395|Device|PARO therapy seal|PARO, a baby harp seal, is an advanced interactive, therapeutic medical robot developed by AIST, a leading Japanese industrial automation pioneer. It allows the documented benefits of animal therapy to be administered to patients in environments such as hospitals and extended care facilities where live animals present treatment or logistical difficulties.
15723788|NCT05075382|Procedure|Elbow surgery for fracture|This group will undergo a surgery in order to fix a broken elbow.
15723789|NCT05075369|Diagnostic Test|water drinking test|Water drinking test-glaucoma diagnostic test - marker for outflow facility reserve to detect IOP instability when the body ingests 800 ml of water within a 5 minute period of time
15723790|NCT05075356|Device|The intelligent total body scanner (iToBoS)|"The intelligent total body scanner (iToBoS) device will be an AI diagnostic platform for early detection for melanoma, which includes a novel total-body high-resolution scanner and a Computer Aided Diagnostics (CAD) tool. The prototype iToBoS imaging device used in this study, will not have the integrated CAD system.
~The device consists of a horizontal bed on which the participant would lie on. The bed will slide under a series of 5 arc shaped rails that have a total of 15 vision units mounted on rails (3 vision units per arc). The vision units incorporate high-resolution cameras and LED lighting system. When imaging is initiated by an operator, the vision units systematically move along the arch rails taking numerous images capturing majority of the skin surface. The imaging process will take approx. 10 minutes.
~Purpose built software will be used to stitch images together to create a body avatar on which skin lesions can be viewed and monitored with."
15723791|NCT05075343|Device|Custom foot orthoses|"3D printed custom foot orthoses (CFO) were designed by the same experimented podiatrist based on a detailed clinical and biomechanical examination and a 3D foot scan obtained for each participant. The degrees and types were adjusted at the CFO delivery according to each patient's comfort and tolerance.
~The intervention period was 7weeks. The participants were taught to wear the CFO progressively during the first two weeks to allow for the lower limbs' muscles and structures to adjust to the CFO, and to wear the orthoses for the next 5 weeks, 7 days a week as often as they could."
15723792|NCT05075330|Behavioral|Opioid Use Disorder Stigma Reduction|Billboards with destigmatizing language regarding opioid use disorder placed in the community.
15723793|NCT05075317|Behavioral|Standard cardiac rehabilitation|Standard, multi-dimensional cardiac rehabilitation program.
15723794|NCT05075317|Behavioral|Time-Restricted Eating|Counselling to restrict their eating to between 11 am and 7 pm and to consume water-only for the remaining 16 hours per day
15723795|NCT05075304|Drug|BDB-001 injection|IV infusions of Injection diluted in sodium chloride
15723796|NCT05075304|Drug|BDB-001 injection|IV infusions of Injection diluted in sodium chloride
15723797|NCT05075304|Drug|BDB-001 injection|IV infusions of Injection diluted in sodium chloride
15723799|NCT05075265|Drug|Methadone|Standard dose of 0.2 ug/kg before Cardiopulmonary Bypass.
15723801|NCT05075226|Device|Vivity Extended Depth of Focus|Cataract surgery
15723805|NCT05075200|Drug|Tranexamic acid|Participants in both groups will be given single intravenous bolus of TXA 20 mg/kg over 15 min after induction of spinal (or other regional technique) or general anesthesia as per standard of care.
15723806|NCT05075187|Diagnostic Test|Genetic Screening|Blood samples will be collected from clinically diagnosed or suspected FTD patients and will be analysed for a broad range of pathogenic variants in genes associated with FTD.
15723807|NCT05075161|Drug|Pirfenidone|From days 1-7: 801mg/day; from days 8-14:1602mg/day, from day 15 to ICU discharge 2403 mg/day. All drugs will be delivered by a nasogastric tube divided in 3 daily doses.
15723808|NCT05075161|Drug|Placebo|All drugs will be delivered by a nasogastric tube divided in 3 daily doses.
15723809|NCT05075148|Other|radiology|Interventional radiology for aneurysmal bone cyst ( percutaneous alcoholization, vascualr embolisation)
15723810|NCT05075135|Device|Swibrace 3D-splint|"The Swibrace 3D splint is a custom-made splint. For scanning of the forearms, the investigators will use the scanner HandySCAN300 and the therewith delivered software VXElements, the latter being necessary to create an accurate scan on the computer.
~Printing of the splint will be done by Materialise, Belgium."
15723811|NCT05075135|Device|Plaster cast|The conservative gold standard treatment of distal radius and scaphoid fractures is applying a plaster cast. Therefore, patients in the control group follow standard therapy procedures.
15723812|NCT05075122|Biological|UV1|UV1 vaccination (300 μg) UV1 vaccination will be applied in a dense schedule with three vaccinations during one week before initiation of pembrolizumab, followed by 5 additional vaccinations every 3 weeks on d1 of each cycle (5 cycles in total, duration of treatment will be 13 weeks in total, regular EOT at week 14)
15723987|NCT05073692|Drug|Exenatide (GLP-1RA)|Exposure to agent Exenatide (GLP1-RA)
15723813|NCT05075122|Drug|Sargramostim for Injection|75 μg GM-CSF as adjuvant per vaccination. Applied in a dense schedule with three injections during one week before initiation of pembrolizumab, followed by 5 additional injections every 3 weeks on d1 of each cycle (5 cycles in total, duration of treatment will be 13 weeks in total, regular EOT at week 14).
15723814|NCT05075122|Drug|Pembrolizumab injection|200mg flat dose iv every 3 weeks. Pembrolizumab will be administered beyond the EOT visit at physician discretion until disease progression and up to a maximum of two years (standard of care)
15723815|NCT05075109|Device|High Frequency TENS|30 minutes of high frequency TENS (100 Hz, 200 us) over the muscle belly of triceps and wrist extensors, for 5 days per week over 8 weeks combined with task related training.
15723816|NCT05075109|Device|Low Frequency TENS|30 minutes of low frequency TENS (20 Hz, 0.2 us) over the muscle belly of triceps and wrist extensors, for 5 days per week over 8 weeks. And combined with 30 minutes of TRT.
15723817|NCT05075109|Other|Task Related Training|"Each session of TRT would include:
~1. postural control, 2. shoulder mobilization, 3. weight bearing exercises 4. Functional activities that will comprise of simple tasks to more advanced movement patterns as follows:
~Reaching activities
~Forward supported reach with cane on tabletop
~Reaching against gravity
~Reaching overhead with active wrist/hand movements
~Dynamic reaching to target e.g. catch a ball
~Grasping, holding and release
~Grasp, hold and release objects with gravity minimized
~Pick up and move/release small objects on table
~Pick up and move/release large objects without proximal support
~Incorporate pinch grips in hold and release including stacking, lifting and overhead activity
~Upper limb ADL
~Brushing hair, putting on scarf
~Opening bottles, turning off water tap
~Writing, drawing
~Folding of towels, hanging towels and setting table
~Self-feeding"
15723818|NCT05075096|Other|No intervention.|No intervention observational study.
15723823|NCT05075018|Other|Observational|Individuals' musculoskeletal problems will be evaluated with the Cornell Musculoskeletal Disorder Questionnaire, quality of life, physical activity, Nottingham Health Profile physical activity International Physical Activity Questionnaire, endurance stabilizer device, functional exercise capacity 1 minute sit and stand test, shortness of breath using the Modified Borg Scale. Measurements will be made only once.
15723824|NCT05075005|Other|Treatment Cohort|Subjects will walk on a specified University of Florida Natural Area Teaching Laboratory's (NATL) nature trail for approximately 30 minutes, three times per week for 8 weeks while wearing the minimalist shoes provided by the study team. Time, distance, and GPS walking route will be recorded utilizing the MapMyRun smartphone application, which is free to download and easy to use. The study team will assist each subject with downloading the application onto their smartphone and provide a brief training on app use at their pre-trial visit. Subjects will be asked to save each training session within the app to report to the study team upon completion of the 8-week training protocol. Subjects will be instructed to walk at a comfortable pace and to stop if they begin experiencing increased pain or discomfort.
15723825|NCT05075005|Other|Control Cohort|Subjects will walk on hardscapes (e.g. sidewalk, asphalt, track, etc) for approximately 30 minutes, three times per week for 8 weeks while wearing the minimalist shoes provided by the study team. Similarly to the treatment group, subjects will be asked to utilize the MapMyRun smartphone application to record their training sessions. Subjects will be instructed to walk at a comfortable pace and to stop if they begin experiencing increased pain or discomfort.
15723826|NCT05074992|Drug|Ipilimumab|Ipilimumab is a monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.
15723827|NCT05074979|Other|telerehabilitation|While telerehabilitation sessions will be applied to the participants in the telerehabilitation group for 6 weeks, home exercise program will be given to the home exercise program group and will be applied for 6 weeks.
15723828|NCT05074979|Other|home exercise program|While telerehabilitation sessions will be applied to the participants in the telerehabilitation group for 6 weeks, home exercise program will be given to the home exercise program group and will be applied for 6 weeks.
15723829|NCT05074979|Other|informed program|will informed after COVID 19
15723830|NCT05074966|Drug|Experimental: mXELOX plus cetuximab|"Patients will receive the study drug after randomization, and those with effective efficacy evaluation (CR, PR or SD) will receive intravenous chemotherapy for up to 9 cycles, and then enter the maintenance treatment stage until PD, death, intolerable toxicity or withdrawal of informed consent (whichever occurs first)
~Cetuximab: 500 mg/m2, IV, d1, q2w; Oxaliplatin: 85 mg/m2, IV, d1,q2w; Capecitabine: 850 mg/m2, po, bid, q2w maintenance stage: Cetuximab: 500 mg/m2, IV, d1, q2w; Capecitabine: 850 mg/m2, po, bid, d1-10, q2w;"
15723831|NCT05074966|Drug|Active Comparator: FOLFOX plus cetuximab|"Patients will receive the study drug after randomization, and those with effective efficacy evaluation (CR, PR or SD) will receive intravenous chemotherapy for up to 9 cycles, and then enter the maintenance treatment stage until PD, death, intolerable toxicity or withdrawal of informed consent (whichever occurs first)
~Oxaliplatin 85 mg/m2, IV d1; Leucovorin 400 mg/m2 IV d1; 5-FU 400 mg/m2 IV bolus on d1, then 1200 mg/m2/d x 2d(total 2400 mg/m2 over 46-48 hours) IV continuous infusion; q2w maintenance stage: Cetuximab: 500 mg/m2, IV, d1, q2w; Leucovorin： 400 mg/m2 IV d1, q2w; 5-FU： 400 mg/m2 IV bolus on d1, then 1200 mg/m2/d x 2d(total 2400 mg/m2 over 46-48hours) IV continuous infusion, q2w （Cetuximab combined with capecitabine can be used according to the patient's wishes and the nursing situation of intravenous catheterization）"
15723833|NCT05074940|Drug|Amivantamab|Patients will receive amivantamab at 1050mg weekly for the first cycle and biweekly thereafter (1400mg for patients ≥80kg).
15723834|NCT05074927|Diagnostic Test|diaphragm ultrasonography|For all patients with confirmed COVID-19 who had been discharged from CHRU Hospital in Limoges (France) : diaphragm ultrasonography at 3 (M0) and 6 months (M3) after the end of his hospitalisation
15723835|NCT05074914|Procedure|oesophagectomy|removal of oesophagus
15723984|NCT05073692|Drug|GLP-1RA|Exposure to the class of drugs known as Glucagon-like peptide-1 receptor agonists (GLP-1RA)
15723836|NCT05074901|Behavioral|digital behavioral intervention|interaction with a conversational agent to implement physical and cognitive programs
15723839|NCT05074875|Other|Questionnaires and Patient Reported Outcomes (PROs)|"EuroQol 5 Dimensional Quality of Life Questionnaire (EQ-5D).
~St. George's Respiratory Questionnaire (SGRQ)
~Impact of Events Scale Revised (IES-R)
~Generalized Anxiety Disorder 7-Item (GAD-7)
~Patient Health Questionnaire (PHQ-9)"
15723840|NCT05074875|Diagnostic Test|Nasal Swab COVID-19 reverse transcription polymerase chain reaction test (RT-PCR)|If required by the local site's COVID-19 guidelines, subjects should have the COVID-19 RT-PCR Nasal Swab collected at the beginning of the visit or within 5 days prior to the scheduled visit.
15723841|NCT05074875|Genetic|Blood Samples for Biomarkers|Venous blood will be collected using pre-labeled tubes.
15723842|NCT05074875|Diagnostic Test|High Resolution Computed Tomography|Subjects will have HRCTs at Visits 1, 2, 3, and 4. Inpatient HRCT scans will be collected during the baseline visit (V0 or V1)
15723843|NCT05074875|Diagnostic Test|Physical Exam and Vital Signs|"A complete physical exam, including height, weight, general appearance, neck, lungs, cardiovascular system, abdomen, extremities, and skin will be performed at Visit 1.A brief physical exam will be completed at subsequent visits, including weight, general appearance, lungs, cardiovascular symptoms, extremities, and other body systems pertinent to the participants health status, at the discretion of the investigator.
~Blood pressure, heart rate, and oxygen saturation will be collected at all visits, prior to blood draws and after subjects have rested."
15723844|NCT05074875|Diagnostic Test|Medical Research Council Sum Score|The Medical Research Council Sum Score (MRC-SS) is used globally to detect peripheral muscle strength and to help diagnose ICU-acquired muscle weakness. The MRC-SS ranging from 0 (complete paralysis) to 60 (normal).
15723845|NCT05074875|Diagnostic Test|Hand Grip Strength|Each subject will have hand grip strength measured at each visit. This is being done in order to assess the maximum isometric strength of hand and forearm muscles.
15723846|NCT05074875|Diagnostic Test|Spirometry|Spirometry will be assessed at Visits 1, 2, 3 and 4. Each site will use its own spirometry machine. Each subject should use the same machine at each visit and conduct measurements at approximately the same time. Before any testing, the maneuver should be demonstrated to the subject. The spirometry should be reviewed by the investigator.
15723847|NCT05074875|Diagnostic Test|Diffusing Capacity of Carbon Monoxide|The site will use its own DLCO equipment for measurements at Visits, 1, 2, 3, and 4. The Single-breath DLCO maneuver will be carried out in accordance with the 2017 American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines. Subjects should use the same device at approximately that same time at each visit. The maneuver should be demonstrated to the subject prior to the test.
15723848|NCT05074875|Diagnostic Test|6 Minute Walk Test|"The 6 Minute Walk Test (6MWT) will assess exercise capacity and tolerance. 6MWTs will be conducted at Visits 1, 2, 3, and 4.
~The procedure of the 6MWT should be explained and demonstrated to the subject prior to the start of the test."
15723849|NCT05074875|Diagnostic Test|Sit to Stand (STS) Measurement|The STS will be conducted at Visits 1, 2, 3, and 4 to assess the physical functioning of the adult participants.
15723850|NCT05074862|Dietary Supplement|KetoneAid KE4 Pro Monoester|A dietary supplement containing ketone monoester.
15723851|NCT05074862|Dietary Supplement|Maltodextrin and fat-based placebo|Dosis isocaloric to the KetoneAid Arm
15723852|NCT05074849|Behavioral|A 90-minute self-care education + bi-weekly 30-minute one-on-one follow-up phone discussion|A 90-minute group session to educate patients on foot self-care strategies (daily foot hygiene and cleanliness, foot protection, use of insoles and smart watch). Follow-up Care: A biweekly 30-minute one-on-one follow-up phone discussion (i.e., daily foot hygiene and cleanliness, foot protection, use of insoles and smart watch, addressing feedback and questions regarding the intervention and prevention of foot-related complications).
15723853|NCT05074836|Dietary Supplement|Formula milk|"Brand name: Yili (QQ star formula milk);
~Type: SCI-PRO NUTRI 5+6TM formula milk designed for young children aged over 3 years;
~Dosage: 195ml*2/d;
~Intervention duration: 12 months"
15723854|NCT05074836|Dietary Supplement|Regular milk|"Brand name: Yili；
~Type: regular milk (pure milk);
~Dosage: 195ml*2/d;
~Intervention duration: 12 months"
15723855|NCT05074836|Other|Control foods|"Brand: N/A;
~Food type: grain foods (e.g., bread);
~Dosage: 20-40g * 2/d grain foods
~Intervention duration: 12 months"
15723860|NCT05074797|Diagnostic Test|laboratory|laboratory data
15723861|NCT05074784|Device|IOPI Therapy|Obtain IOPI reading at start of session, record the best of 3 readings as baseline strength. Calculate exercise resistance for session at 60% of baseline strength. Using the IOPI, participants will perform 24 sets of 5 repetition at anterior position, allowing for 30 secs rest in between sets.
15723862|NCT05074784|Device|Tongue Depressor Traditional Intervention|Using the tongue depressor, participants will be prompted to stick their tongue out as much as they can and to push hard against the tongue depressor for 10 seconds. They will be required to repeat this action 10 times, constituting one set. They will be asked to perform 3 sets, with 30 secs of rest between each set
15723884|NCT05074576|Other|Mulligan group|"Ultrasound (8minutes, 1.5 w/cm2, pulsed), conventional transcutaneous electrical nerve stimulation (TENS) (20 minutes, 60-120 Hz frequency) and hot pack application (20 minutes) and interferential current (100 rpm) as electrotherapy agents. In addition to the conventional treatments, Sustained Natural Apophysial Gliding (SNAG) a type of Mulligan mobilization technique is applied. Mobilization is performed by giving 15-20 seconds rest between 3 sets of 4-5 repetations.
~Patients were treated in a sitting position. SNAG technique was applied by the physiotherapist at each on spinal level. Active movement with using passive manual force in the direction of translation or rotation was applied to the cervical vertebrae. At the end range of the joint, overpressure was applied by the patient himself"
15724269|NCT05071183|Drug|Trametinib|Oral trametinib tablets
15723868|NCT05074706|Biological|IgG antibodies to Sars-Cov-2|Samples will be collected between 30 and 60 days after second vaccine dose.
15723869|NCT05074706|Biological|QuantiFERON SARS-CoV-2 test|Samples will be collected within 9 months after completion of the vaccination series
15723870|NCT05074693|Other|EASE app|Mobile intervention designed to reduce ongoing mental health concerns among BLAI individuals with elevated anxiety and/or depressive symptoms (Easing Anxiety Sensitivity for Everyone [EASE] App). Using a precision medicine approach, EASE targets anxiety sensitivity, a transdiagnostic individual difference factor implicated in the etiology, maintenance, and progression of anxiety and depressive symptoms. EASE includes COVID-19 symptom monitoring, exposure management skills, and psychoeducation on COVID-19-related stress and the impact of stress on susceptibility to infection and disease progression
15723871|NCT05074693|Other|Educational Videos|A series of educational videos covering topics such as meditation, mindfulness, and stress reduction techniques.
15723872|NCT05074680|Diagnostic Test|Blood sampling|Blood serum samples will be collected for analysis of COVID-19 antibody levels. For participants who consent to the optional study, a second blood sample will also be drawn into EDTA tubes (plasma)
15723875|NCT05074641|Other|Direct myofascial release treatment|Applied with Forearm and/or ulnar border of the palm. Deep Pressure will be applied and glided medially towards the base of the neck and/ or towards the upper scapular region
15723876|NCT05074641|Other|Bowen therapy|Thumb of the therapist will be placed on the top of the targeted muscle. The skin will be carried away gently from the spine without disturbing the muscle. The thumb was then hooked into the lateral aspect of the muscle to form a pressure on the muscle. Then the thumb will be flattened in the medial direction, when this happened the muscle would plop or respond in some way.
15723877|NCT05074628|Drug|Nitrofurantoin capsules|methyl cellulose powder (MC) will be added to Nit solution to get a thick paste like consistency mixture.
15723878|NCT05074615|Other|Cranio-Cervical Flexion Training|"Participants of this group will receive conventional training along with Cranio-cervical flexion training:
~The pressure cuff is placed behind the neck just next to the occiput and inflated up to a baseline pressure of 20 mmHg. The patient is asked to perform Cranio-Cervical Flexion (CCF) to sequentially reach 5 pressure targets in 2 mmHg increments from a baseline of 20 mmHg to the final level of 30 mmHg. For each target level, the patient is instructed to maintain the contraction for 10 sec for 10 repetitions with brief rest periods between each contraction i.e., 3-5 seconds. Once a set of 10 repetitions of 10 sec is achieved at one target level, the exercise is progressed to train at the next target level up to the final target level at 30 mmHg.
~Conventional therapy will be given along with home plan. Exercise protocol will consist of 30 minutes. Exercise will have total 3 sessions/week for 3 weeks."
15723879|NCT05074615|Other|Conventional Therapy|"Participants of this group will receive only conventional therapy and home plan will be given which includes;
~Hot pack placed on the posterior neck for 15 minutes.
~Transcutaneous electrical nerve stimulation (TENS) with a frequency of 80 Hz for 20 minutes with 10-30 mA intensity.
~Isometric exercises: Isometric neck flexion, extension, side bending exercises. 10 repetitions. Hold period is 10 seconds for each movement. Resistance would be provided manually by the therapist.
~Stretching exercises: Passive stretching for Sternocleidomastoid, Trapezius, Pectoralis Major. 10 reps and each stretch maintained for 10 seconds.
~Home Plan: Patients will be given a home plan of self-stretches and isometrics and instructions on how to perform and number of repetitions will be guided. Exercise protocol will consist of 25 minutes. Exercise will consist of total 3 sessions/week for 3 weeks"
15723880|NCT05074602|Drug|SHR8008|Dosing frequency: During Part 1, administered orally once daily for 2 days. During Part 2, administered orally once weekly for 11 weeks starting from Week 3, Route of administration: oral
15723881|NCT05074602|Drug|Fluconazole|Dosing frequency: During Part 1, administered orally 3 sequential doses (every 72 hours), During Part 2, administered orally once weekly for 6 Months starting from Week 3. Route of administration: oral
15723882|NCT05074589|Drug|Irinotecan liposome、5-Fluorouracil、Leucovorin|Irinotecan liposome、5-Fluorouracil、Leucovorin
15723883|NCT05074589|Drug|Placebo、5-Fluorouracil、Leucovorin|Placebo、5-Fluorouracil、Leucovorin
15723885|NCT05074576|Other|Control group|Electroterapy agents are applied in the same conditions with Mulligan Group. Active neck, shoulder and thoracic region exercises for correction postural misalignment are performed in both groups. All exercises were done in 3 sets of 10 repetitions. Stretching exercises of upper part of Trapezius, sternocleidomastoideus and pectoral muscles are done with 10 repetitions and for 15-30 seconds.
15723985|NCT05073692|Drug|SGLT2i or GLP-1RA|Exposure to either SGLT2i or GLP-1RA
15723986|NCT05073692|Drug|Linagliptin (DPP4)|Exposure to agent Linagliptin (DPP4)
15723886|NCT05074563|Other|REsOluTioN (Resilience Enhancement Online Training for Nurses)|The online REsOluTioN training involves virtual or face-to-face mentorship sessions and facilitated online interactive group sessions on four topics (Building hardiness and maintaining a positive outlook, Intellectual flexibility and Emotional Intelligence; Achieving life balance and enabling spirituality and Reflective and critical thinking). The training will be of four-week duration. Over the four-week period, the training will comprise 4x120 minute facilitated online group sessions; 4x30 minute independent learning activities; and eight 3:1 online mentoring sessions delivered between 30 and 60 minutes at flexible timings.
15723887|NCT05074563|Other|Control|Nurses randomised to the control group will only be invited to take part in the pre- and post- intervention surveys, but will not use the online training. However, after completing the survey, nurses will be given the opportunity to complete the pre-work and access the facilitated sessions of the training so that they can receive their CPD certificate.
15723888|NCT05074550|Drug|PPMX-T003|As an observation and evaluation method, for each dose, in principle, inpatient observation is performed for 1 week from the day before administration, and then safety and pharmacodynamic tests are evaluated by visiting the hospital every 2 weeks.
15723889|NCT05074537|Diagnostic Test|MRI exam|Participants who are receiving standard of care or investigational MRI exams at the Wright Center will be eligible for enrollment in this data bank.
15723890|NCT05074537|Diagnostic Test|PET/CT imaging exam|Participants who are receiving standard of care or investigational PET/CT exams at the Wright Center will be eligible for enrollment in this data bank.
15723891|NCT05074537|Diagnostic Test|CT imaging exam|Participants who are receiving standard of care or investigational CT exams at the Wright Center will be eligible for enrollment in this data bank.
15723892|NCT05074524|Device|Repetitive Transcranial Magnetic Stimulation|Active rTMS treatment will be delivered at 10 Hz, 100% resting motor threshold, 2000 pulses delivered in five seconds per train with 10-second intra-train pause, delivered once daily five days per week, Monday through Friday for 10 days (10 total treatments). This protocol is adapted from Shen and colleagues (2016), who did not report any adverse events. Liu and colleagues (2020) also used the same protocol and only reported mild side effects of dizziness, headache, and insomnia, which resolved by the 30-day follow-up. However, it is unclear whether these side effects resolved sooner than the 30-day follow-up.
15723893|NCT05074524|Device|Sham Repetitive Transcranial Magnetic Stimulation|The control group will undergo the same seat positioning and comfort measures but will not have a resting motor threshold determination. The coil will be turned 90 degrees counter-clockwise, and the side of the coil will rest on the scalp over the area of the skull corresponding to the motor cortex, so the participant will feel the coil making contact. The same treatment protocol in the active rTMS group will be initiated to mimic the sound of rTMS treatment, though no pulses will be delivered to the participant because of the coil rotation.
15723894|NCT05074498|Drug|TB006|intravenous infusion
15723895|NCT05074498|Drug|Placebo|intravenous infusion
15723896|NCT05074485|Drug|anakinra|intravenous injection of 100 milligrams anakinra
15723897|NCT05074485|Drug|Placebo|intravenous injection of 1 milliliter normal saline
15723898|NCT05074485|Other|Nociceptive pain challenge|The experimental, standardized, nociceptive pain challenge will induce a moderate level of sustained pain. The pain challenge involves a masseteric injection in the left or right jaw muscle of normal saline (0.15 ml bolus of 0.9% normal saline) over a 15 second period followed by continuous infusion via a closed loop infusion system for 20 minutes.
15723899|NCT05074472|Drug|ZB131|ZB131 will be administered once weekly by intravenous infusion with the weight at baseline used for mg/kg dose calculations.
15723902|NCT05074446|Other|stereotype threat manipulation|"Stereotype threat is the thought that a person will be negatively evaluated and judged regarding a negative stereotype that belongs to the group to which he/she belongs.
~Stereotype threat manipulation will be performed on the non-intensivist participants in the experimental group just before they are taken into the testing room. For manipulation, the following sentences will be said to the participants in the experimental group: Studies have shown that intensive care workers are more successful in cardiopulmonary resuscitation. In this study, we aim to compare the cardiopulmonary resuscitation performance between intensive care units and other branches.. The other non-intensivist participants (Control Group) will not be given any prior information."
15723903|NCT05074433|Drug|casirivimab+imdevimab|Co-administered sequentially subcutaneous (SC)
15723904|NCT05074433|Drug|Placebo|Administered SC
15723906|NCT05074394|Biological|COVI-DROPS|COVI-DROPS is a fully human monoclonal antibody that is a neutralizing antibody to SARS-CoV-2
15723907|NCT05074394|Drug|Placebo|Diluent solution
15723908|NCT05074381|Other|Dry Needling|Dry needling (DN) is a myofascial treatment technique, in which a thin, solid filiform needle is inserted directly into the MTrP. During dry needling, local twitch responses (LTR) can be elicited. These are involuntary contractions of muscle fibers, leadi
15723909|NCT05074381|Other|Sham Needling|During sham needling, a solid, filiform needle is inserted in the skin surface at the trigger point location, without penetrating the fascia and muscle tissue.
15723910|NCT05074368|Biological|ChAdOx1-nCov-19 (Astra-Zeneca)|vaccine inoculation and mixed inoculation
15723911|NCT05074368|Biological|SARS-CoV-2 messenger RNA-1273 (Moderna) vaccine|vaccine inoculation and mixed inoculation
15723912|NCT05074355|Drug|Azacitidine|Azacitidine is a hypomethylating agent that works by activating certain genes in the body to help cells mature and to kill abnormal bone marrow cells.
15723913|NCT05074355|Drug|Venetoclax|Venetoclax is a drug that blocks a protein called B-cell lymphoma (BCL2) protein from working. BCL2 is a protein that helps control whether a cell lives or dies and is thought to help cancer cells to live. Blocking BCL2 is believed to help kill cancer cells.
15723914|NCT05074329|Device|Moventis PNS|Moventis PNS is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin.
15723915|NCT05074303|Biological|Influenza Vaccine|All subjects will receive the influenza vaccine.
15723916|NCT05074303|Dietary Supplement|Beta-glucan|2 - 250 mg capsules/day of beta-glucan derived from Baker's yeast
15723917|NCT05074303|Dietary Supplement|Placebo|2 - 250 mg capsules/day of cellulose
15723918|NCT05074290|Drug|Epidiferphane|"During the phase I portion of the study, subjects will be assigned to take either two (half target dose) or four (full target dose) Epidiferphane tablets orally three times daily following a 3 + 3 design. Three subjects will be sequentially enrolled at each of the 2 dose levels (beginning with the half target dose) until at least one dose-limiting toxicity (DLT) occurs. Dosing escalation will be stopped if two or more DLTs occur at either dose level. The maximum tolerated dose will be one dose level lower than the dose level at which 2 or more DLTs occur. Dose escalation will occur separately for each of the two taxane regimens (weekly paclitaxel or docetaxel every 3 weeks).
~All subjects in the phase II portion of the study will receive the maximum tolerated dose determined in the phase I portion of the study for their taxane regimen.
~Subjects in both portions of the study will receive treatment with Epidiferphane for a maximum of three months."
15723919|NCT05074290|Drug|Taxane Chemotherapy|All subjects on both phases of the study will be concurrently treated with a taxane regimen containing either paclitaxel given weekly or docetaxel given every 3 weeks. The choice of taxane regimen will be determined by the treating physician prior to consenting to participate in this trial.
15723930|NCT05074238|Other|Zinc containing suncreen|"The study participant will be randomized via a randomization tool within the REDCap database as to which half of the wound (A or B) the patient will be asked to apply zinc containing sunscreen for the duration of the study."
15723931|NCT05074225|Other|Electrodesiccation and Curettage vs Excision|"Factorial Assignment.
~At the follow-up visit, two blinded observers will record their scores independently using the physician observer scar assessment score instrument (POSAS)."
15723932|NCT05074212|Other|Factorial Assignment|At the follow-up visit, two blinded observers will record their scores independently using the physician observer scar assessment score instrument (POSAS).
15723933|NCT05074199|Procedure|W-plasty/Linear closure|"The patient's wound will be labeled A if it is on the left or superior side of the investigator and B if it is on the right or inferior side. A predetermined, concealed randomization number will be obtained from the RedCap randomization module, which will specify how side A is to be treated. Side B will be treated the opposite way as A. Side A will always be closed first. The side assigned to be closed in a traditional straight line (SL) will have the standing cutaneous deformity (dog ear) excised in the standard manner using Burrow's triangles, resulting in an elliptical defect amenable to linear closure. The side assigned to be closed with W-plasty will have the dog ear excised in a zig-zag fashion consistent with the W plasty flap design. Both sides of the wound will receive subcuticular closure with interrupted subdermal sutures as is the standard of care, followed by a standard running cuticular closure with absorbable suture material."
15723934|NCT05074186|Device|neurological thrombectomy device is an investigational device.|Revascularization device is an investigational device.
15723936|NCT05074160|Device|OCS Liver|Multi-center, observational post-approval registry of adult primary liver transplant recipients who are transplanted with an OCS Liver-perfused DBD or DCD donor liver according to the approved indication and that match the eligibility criteria below.
15723937|NCT05074147|Drug|Reduction in the duration of antibiotic therapy 3 weeks or 6 weeks|"Drugs :
~Rifampin (IP an PO) : 10mg/Kg/12h
~Ofloxacin (PO) : 200Mg/8h
~Levofloxacin (PO) : 500mg ot 1g/ twice a day
~Ciprofloxacin : IV : 400mg/8h if Pseud spp ; 400mg/12h for others Gram-negative bacilli strains; PO : 1gr/12h if Pseud spp ; 750mg/12h for others Gram-negative bacilli strains
~Clindamycin : 600-900mg/8h
~Fusidic Acid : 500mg/8h
~Teicoplanin : 10mg/kg/12h for 5 dosis in combination, then in monotherapy.
~Ceftasidim : 2g/8h if Pseud spp ; 2g/12h for others Gram-negative bacilli strains
~Trimethoprim-sulfamethoxazole (800mg/160mg) : once per day if patient < 80Kg ; one and a half per day if patient > 80Kg.
~Doxycyclin : 200mg/day
~Minocyclin : 100mg/8h to 12h
~Ceftriaxon : 1g to 2g/day in IV, IM or SC
~Cefotaxim : 1g to 2g/day in IV
~Pristinamycin : 1g thrice a day"
15723938|NCT05074134|Drug|[14C]-TNP-2092|Subjects will receive a single intravenous (IV) dose of 300 mg/3 µCi [14C]-TNP-2092 administered over 60 minutes (± 10 minutes).
15723941|NCT05074108|Behavioral|Pilot study|Aiming for an interaction 6 week course that will discuss many aspects of health and wellness.
15723942|NCT05074095|Other|retrospective analysis|
15723943|NCT05074082|Procedure|Flap reconstruction|Formation of a (myo-/fascio-)cutaneous flap for repair of a skin and soft tissue defect
15723946|NCT05074043|Combination Product|antiviral, surgical|surgical debridment
15723947|NCT05074030|Behavioral|Personalized Normative Feedback|Normative Feedback on drinking behaviors.
15723948|NCT05074030|Behavioral|Coping-Motive Specific Personalized Feedback Intervention plus an Ecological Momentary Intervention (PFIcope+EMI)|An EMA plus EMI intervention to decrease drinking to cope behaviors among emerging adults receiving psychiatric treatment.
15723950|NCT05074004|Other|Psychoeducation|Psychoeducation sessions were conducted by two psychiatric nurses (İK, SS) who are experts in their fields and have psychoeducation and group leadership certificates. Each session was held once a week in 30-45 minutes sessions. The training was carried out interactively; approximately the first 5 minutes were spent on warm-up, the basic information of that day's session was given for 25 minutes, and the last 10 minutes were in the form of questions and answers. Two separate groups were formed according to the day hospital program of the patients, and the psychoeducation program was carried out in two separate groups to conduct psychoeducation effectively.
15723951|NCT05073991|Procedure|Lung surgery|Patients underwent lung surgery including wedge resection, lobectomy, segmentectomy, and pneumonectomy.
15723952|NCT05073991|Procedure|Open aortic surgery|Patients underwent open thoracic surgery or thoracoabdominal aortic surgery.
15723953|NCT05073991|Procedure|TEVAR|Patients underwent TEVAR.
15723954|NCT05073991|Procedure|EVAR|Patients underwent EVAR.
15723955|NCT05073978|Other|No intervention|This is an observational study without any intervention
15723956|NCT05073965|Dietary Supplement|Vitamin D|Subjects were assigned to receive a 1000IU vitamin D supplement dose
15723957|NCT05073965|Other|Placebo|Subject were assigned to receive a placebo
15723958|NCT05073952|Procedure|Connective tissue graft|Implants will be placed with a flap and a connective tissue graft.
15723959|NCT05073952|Procedure|Flapless|Implants will be placed with a flapless approach
15723962|NCT05073926|Other|No intervention is part of the study protocol|No intervention is part of the study protocol. The choice of treatment for latent tuberculosis is is made by the treating physician.
15723963|NCT05073913|Diagnostic Test|Vascular remodeling characterization|Pulse wave velocity measure High frequency ultrasonography for vascular imaging Endothelial function test Left ventricular mass by echocardiography Measurement of GFR (Glomerular Filtration Rate) with 99mTc DTPA
15723964|NCT05073900|Procedure|Rhomboid intercostal block|two regional anesthesia block techniques are applied
15723965|NCT05073887|Procedure|Current Targets|blockade and radio frequency stimulation of genicular nerves
15723966|NCT05073874|Other|Functional Near-Infrared Spectroscopy (fNIRS)|The hemodynamic response in prefrontal cortex will be measured using an Octomon+ system (Artinis). Eight emission and two detector probes will be arranged on the participant's forehead.
15723967|NCT05073861|Behavioral|STEM learning|"Classes will be randomly assigned to the experimental group and to the control group. As treatment, the experimental group will be assigned to an intervention that uses a STEM blended learning app with gamified videos for content knowledge along with hands-on experiments. The videos are fictitious educational narratives related to the content knowledge and students were asked to step into the shoes of the cartoon scientist (a chipmunk) to solve various problems during the stories. The science experiments will be completed with step-by-step video guidance on the app. The control group will be assigned to read the same content on an e-book and receive an arts-and-craft kit for each lesson that is unrelated to the content knowledge."
15723968|NCT05073835|Drug|Semaglutide 3 mg|Semaglutide 2.4 mg/week, subcutaneous injection. Treatment dose: 16 weeks of dose escalation + 52 weeks of study dose (i.e., 2.4 mg/week).
15723969|NCT05073835|Drug|Placebo|Placebo
15723971|NCT05073809|Diagnostic Test|Photoacoustic Imaging Scan|A relatively novel modality that combines exquisite spatial resolution with the ability to image multiple biological tissues, including blood, water and lipid.
15723972|NCT05073796|Device|Cochlea Implant|"examination and documentation of vital signs and concomitant medication
~application of an cochlea implant loan processor (external body surface) with varying stimulus pattern for vestibular stimulation by means of basal, medial and apical electrodes
~attraction of an special mask to determine the subjective visual vertical (SVV)
~assessment of the vertical spatial axis with all electrodes turned off
~assessment of the vertical spatial axis with all electrodes turned on
~assessment of the vertical spatial axis while using basal (12-16) and medial (6-11) electrodes
~assessment of the vertical spatial axis while using basal (12-16) and apical (1-5) electrodes
~assessment of the vertical spatial axis while using medial (6-11) and apical (1-5) electrodes"
15723973|NCT05073770|Device|Titan Condom|"The test condoms have the following specifications throughout the study:
~The plain 64mm condom (i.e., N64): Length 223 ±5mm, width 64±1mm, thickness (single wall) 0.070± 0.005mm, and beading thickness 1.25±0.05mm.
~The plain 69mm condom (i.e., N69): Length 223 ±5mm, Width 69±1mm, Thickness (single wall) 0.070± 0.005mm, Beading thickness 1.25±0.05mm."
15723974|NCT05073757|Device|Personalized guides and plates|Patients will be included in the study and then followed clinically according to the routine care of orthognathic surgery with personalized guides and plates. The only specific act this study is the completion of an OQLQ quality of life questionnaire by patients preoperatively and between 8 to 12 months postoperatively.
15723975|NCT05073744|Drug|Nalbuphine|Nalbuphine hydrochloride injection or morphine hydrochloride injection is used for perioperative tumor ablation
15723976|NCT05073744|Drug|Morphine|Morphine hydrochloride injection is used for perioperative tumor ablation
15723977|NCT05073731|Other|Telerehabilitation-based Upper Extremity Training|"Telerehabilitation has been defined as the delivery of rehabilitation services through information and communication technologies.
~Synchronized telerehabilitation provides the participant with advantages such as customized treatment, instant feedback, and a social environment such as face-to-face training."
15723978|NCT05073718|Drug|Low-dose acetylsalicylic acid|In case of being also positive for the SARS-CoV-2 PCR test, she will be randomised 1:1 to receive, additionally to LMWH for at least 10 days, daily LDASA (150 mg) or placebo, up to 36 weeks of pregnancy.
15723979|NCT05073718|Drug|Placebo|Placebo
15723981|NCT05073692|Drug|SU|Exposure to the class of drugs known as Sulfonylureas (SU)
15723982|NCT05073692|Drug|DPP4|Exposure to the class of drugs known as Dipeptidyl peptidase-4 inhibitors (DPP4)
15723983|NCT05073692|Drug|SGLT2i|Exposure to the class of drugs known as Sodium-glucose cotransporter-2 inhibitors (SGLT2i)
15723988|NCT05073692|Drug|Liraglutide (GLP-1RA)|Exposure to agent Liraglutide (GLP-1RA)
15723989|NCT05073692|Drug|Empagliflozin (SGLT2i)|Exposure to agent Empagliflozin (SGLT2i)
15723990|NCT05073692|Drug|Glimepiride (SU)|Exposure to agent Glimepiride (SU)
15723991|NCT05073692|Drug|Glipizide (SU)|Exposure to Glimepiride (SU)
15723992|NCT05073692|Drug|Glimepiride (SU) or Glipizide (SU)|Exposure to agent Glimepiride (SU) or Glipizide (SU)
15723993|NCT05073692|Drug|SU or DPP4 (excluding saxagliptin and alogliptin)|Exposure to either SU or DPP4 excluding Saxagliptin and Alogliptin
15723994|NCT05073692|Drug|Exenatide (GLP-1RA) or Liraglutide (GLP-1RA)|Exposure to either Exenatide (GLP-1RA) or Liraglutide (GLP-1RA)
15723995|NCT05073679|Drug|Naltrexone Hydrochloride|25mg x 3 days then 50mg a day thereafter
15723996|NCT05073679|Other|Control|Methylcellulose and gelatin capsule only
15723997|NCT05073666|Other|NO INTERVENTION|NO INTERVENTION
15723999|NCT05073640|Drug|Oxopurin|Subjects will receive two capsules per day.
15724001|NCT05073614|Genetic|immunohistochemical detection of Heparanase in chronic gastritis|immunohistochemical detection of Heparanase in chronic gastritis specimens.
15724005|NCT05073575|Procedure|Hyaluronic acid|"After local anesthesia, an access flap will be prepared. Scaling and root planning will be performed combining the use of metal curettes and power-driven instrumentation by means of ultrasonic scaler.
~Hyaluronic acid gel will be applied to exposed roots surface, followed by a tension-free primary closure of the surgery wound by means of 5-0 monofilament (polypropylene) non-resorbable suturing material."
15724006|NCT05073575|Procedure|No-hyaluronic acid|"An access flap will be prepared in order to perform scaling and root planning therapy with the use of metal curettes.
~After intervention, a tension-free primary closure of the interdental papillae and of the mucoperiosteal flaps by means of 5-0 monofilament (polypropylene) non-resorbable suturing materia will be performed"
15724007|NCT05073562|Dietary Supplement|Iron and folic acid (IFA) supplementation|Weekly IFA supplementation for duration of the study.
15724008|NCT05073562|Behavioral|Targeted nutrition education|Structured nutrition education package delivered at household level by trained Community Health Assistants (CHAs)
15724009|NCT05073562|Drug|Mebendazole Pill|One-time deworming treatment with mebendazole.
15724010|NCT05073562|Other|Standard nutrition services|Basic nutrition services currently provided at the health facility and at community level in Liberia
15724014|NCT05073523|Other|Diet|All intervention meals consist of five different food groups including fruits, vegetables, legumes, dairy products, and whole grains. Differences in the proportion of these foods in Meal A-C is tested.
15724017|NCT05073484|Drug|BAT6021|Ⅳ infusions
15724018|NCT05073484|Drug|BAT1308|Ⅳ infusions
15724092|NCT05072938|Drug|Mucotra SR Tablet 150mg|Rebamipide/Nizatidine Combination Therapy
15724093|NCT05072938|Drug|Axid Capsule 150mg|Nizatidine Monotherapy
15724094|NCT05072925|Other|Tobacco products|Products will be used under defined (10 puffs, 30 seconds apart) and ad libitum puffing conditions
15724095|NCT05072899|Procedure|platelet rich plasm|local injection of shoulder joint by platelet rich plasm
15724019|NCT05073471|Behavioral|Patterned Sensory Enhancement (PSE)|"Patterned Sensory Enhancement (PSE) is one of Neurologic Music Therapy (NMT) techniques. NMT is a research-guided clinical model that is driven by advances in neuroscience and the understanding of the perception, production, and performance of music and how music can influence and change non-musical brain and behavior function.
~PSE is a technique that uses the rhythmic, melodic, harmonic, and dynamic-acoustical elements of music to provide temporal, spatial, and. force cues for movements which reflect functional movements of activities of daily."
15724020|NCT05073471|Device|Transcranial Direct Current Stimulation (tDCS)|"We will apply five small electrodes to participant's head. Once the electrodes are in place, a small electrical current will be passed between the electrodes. Participants will also get sham tDCS, which means they will not receive any real stimulation from the electrodes. Most individuals do not find the procedure uncomfortable, and there are no known long-term risks of tDCS. When the current goes through the electrodes, you may feel an itching or tingling sensation under the electrodes or see brief flashes of light, or you may not feel anything at all. If the sensation is unpleasant, participant can report to co-investigator immediately. If participant finds the procedures too uncomfortable, they may stop it at any time. A trained staff member will be present throughout the procedure."
15724021|NCT05073458|Drug|parsaclisinib|parsaclisib will be administered QD orally
15724022|NCT05073458|Drug|placebo|placebo will be administered QD orally
15724023|NCT05073445|Behavioral|SDNN measurement|SDNN measurement during pediatric simulation
15724025|NCT05073419|Other|Standard of Care|Routine monitoring of post AMI patient with clinic visits
15724026|NCT05073419|Device|ICM Implantation|Implantation of ICM through small incision (2 mm) under the skin
15724027|NCT05073406|Other|Altitude exposure in hypobaric normoxic condition|Altitude exposure with oxygen supplementation to achieve normoxia at altitude
15724028|NCT05073406|Other|Altitude exposure in hypobaric hypoxic condition|Altitude exposure with air supplementation to obtain a sham comparator arm
15724029|NCT05073393|Behavioral|Sugar stress|Sucrose rinsing for 14 days (8-10 times a day) followed by 14 days without sucrose rinsing
15724030|NCT05073380|Behavioral|PRO-ECO Intervention|The PRO-ECO intervention will be tailored to individual sites. Through collection of focus group and baseline data, the intervention will be further refined to provide site-specific adjustments, such as specific materials in the built environment design modification or targeted training. Identified features of effective interventions outlined in the literature have informed the development of the intervention foundation and potential tailoring.
15724031|NCT05073380|Behavioral|Normal Daily Practice|ECECs that are randomly assigned to the control group will participate in their normal daily practice, including standard curriculum and outdoor play time. Once post-data collection is complete, control sites will be offered implementation of the PRO-ECO intervention.
15724034|NCT05073341|Other|Nurse-led family intervention|Nurse-led family intervention having three components first is infarmation about the patient's condition and guidance will be given to solve there queries and the emotional support will be given to the primary caregivers of CLD patient's admitted in HDU
15724038|NCT05073302|Procedure|Implantation of Nylon catheter (Device-less sentinel unit)|"Implantation of the Device-Less sentinel units. Ultrasound monitoring will be performed after Device-Less implantation. Standard Islet cell Transplantation: Will occur simultaneously Portal islet transplantation and subcutaneous islet transplantation in the Device-Less sentinel spaces.
~Islets are maintained for a minimum of 6 hours up to 72 hours in supplemented CMRL1066-based media until the time of transplant.
~Concomitant to portal vein infusion, islet transplantation will occur in all four (4) DL sentinel spaces.
~To explant a unit, the Surgeon will make an incision and then carefully dissect the tissue engrafted around the transplant. The entire transplant site and any adherent tissue capsule can then be removed entirely from the pocket."
15724039|NCT05073289|Behavioral|Sandplay activity|The sandplay in psychiatric care, with a creative and fun approach, makes it easier for patients to verbally express their personal life stories and feelings in a safe environment, individually or as a group.
15724040|NCT05073289|Other|Routine Care|Routine care is the care given to the control group by the nurse to the patients in the psychiatry clinic.
15724041|NCT05073276|Other|Physical Therapy|Patient is randomized to the weightbearing group the day after surgery.
15724042|NCT05073263|Other|Physical Therapy|Patient is randomized to the weightbearing group the day after surgery.
15724043|NCT05073250|Drug|IBI376|IBI376 is administered orally once daily at a dose of 20 mg for 8 weeks, followed by an oral dose of 2.5 mg once daily. Patients assessed as PR after 6 cycles of induction therapy will receive another 6 cycles of IBI376 at an oral dose of 2.5 mg once daily.
15724044|NCT05073250|Biological|Rituximab|Rituximab is administered at a dose of 375 mg/m^2 intravenously in the first 4 weeks, once a week. Subsequently, rituximab will be dosed once every 4 weeks. Patients assessed as PR after 6 cycles of induction therapy will receive another 6 cycles of rituximab at a dose of 375 mg/m^2 intravenously once every 4 weeks.
15724045|NCT05073237|Other|Placebo|Daily placebo tablet
15724046|NCT05073237|Drug|conjugated estrogens/bazedoxifene (CE/BZA)|Participants assigned to CE/BZA will receive a daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20mg.
15724096|NCT05072899|Procedure|Hyaluronic acid|local injection of shoulder joint by Hyaluronic acid
15724097|NCT05072886|Drug|AT193|Topical
15724098|NCT05072873|Drug|Topical tranexamic acid|temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid
15724395|NCT05070104|Drug|Bevacizumab|5mg/kg IV
15724051|NCT05073211|Procedure|PDT|A 630 nm red light and a 520 nm green light of the light-emitting diode (LED) device (Nouvo-GB®) with an intensity of 35 mW⁄cm2 was simultaneously illuminated for 10 minutes (a total light dose of 21 J/cm2). Participants received a total of four treatments at 1-week intervals and were followed up 1 and 4 weeks after the last treatment.
15724052|NCT05073198|Other|Education brochure|In the content of the brochure about testicular cancer and CCTM prepared in line with the literature; It includes information such as the definition of testicular cancer, testicular cancer risk factors and symptoms, the importance of early diagnosis in testicular cancer, how CCTM is performed, and what to do in case of differences after the examination. Expert opinion was obtained from three faculty members (a professor from the Department of Urology, a professor in Public Health Nursing and a physician faculty member) regarding the content validity of the educational brochure created before the research.
15724053|NCT05073172|Drug|Calendula Ointment|Applied topically
15724054|NCT05073172|Other|Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment|Applied topically
15724055|NCT05073172|Other|Polyethylene Glycol Hydrogel|Applied topically
15724056|NCT05073172|Drug|Silicone-based Film Forming Topical Gel|Applied topically
15724057|NCT05073172|Drug|Silver Sulfadiazine|Applied topically
15724058|NCT05073159|Biological|Allocating head-of-bed position|Patients would be randomized 1:1 to elevated head of bed (30-degrees or more) or flat (0-degree) position
15724059|NCT05073146|Other|interview|Starting from the user as an extended starting point, through on-site visits and interviews with relevant personnel, such as personal management, professional service teams, cases, family members, other long-term care service providers (home service assistants), etc., collect relevant information and summarize successful strategies and related elements of long-term professional services (including conditions, demand analysis, service usage, professional team interaction, payment and payment systems, characteristics of case, etc.) of model cases.
15724060|NCT05073133|Genetic|OAV101|Gene Therapy IV infusion
15724061|NCT05073120|Other|Piqray Prescriber's/HCP guide for hyperglycemia|oncologists/healthcare professionals (HCPs) prescribing Piqray in the EU/EEA will be provided with the Piqray Prescriber's/HCP Guide for hyperglycemia (educational material). The educational material aims to provide oncologists/HCPs prescribing Piqray with additional measures/guidance prior to, and during treatment with Piqray for the identification and management of hyperglycemia.
15724062|NCT05073107|Other|"Mobile Dental Application, Dental Monitoring (DM)"|"o The Test group will be required to take intra-oral videos (which will be translated into photographs) using the DM application weekly and it will be monitored by the delegated team members:
~Day 0 (To be taken at the clinic)
~Day 7 (To be taken in the evening after brushing teeth)
~Day 14 (To be taken in the evening after brushing teeth)
~Day 21(To be taken in the evening after brushing teeth)
~Day 28 (To be taken before study Visit 2) There is a window period of +1 day for the intra-oral videos."
15724063|NCT05073094|Drug|Esmolol|Esmolol injected intravenously and added to cardioplegia solution
15724064|NCT05073094|Drug|Placebo|Equivalent volume of placebo (saline) as a bolus before aortic cross-clamping and in the cardioplegic solution
15724065|NCT05073081|Other|Prehab for LSS|The 8-week prehabilitation program will be delivered online by physiotherapists, chiropractors, and kinesiologists through synchronous and asynchronous exercise sessions, along with online educational sessions.
15724066|NCT05073081|Other|Usual Care|Participants in the control group will receive usual care as per surgeons' current practice.
15724067|NCT05073068|Behavioral|Timing of exercise|An acute exercise bout of cycling performed in the morning at 9 AM or at 5 PM
15724068|NCT05073068|Behavioral|Control|No exercise
15724125|NCT05072600|Drug|Pembrolizumab|pembrolizumab 200 mg Q3W
15724746|NCT05067283|Biological|Pembrolizumab|Intravenous infusion of 200 mg
15724069|NCT05073055|Procedure|İnguinal Hernia Repair|After hemodynamic stability, the patient was placed in the lateral position and infiltration anesthesia with 2% lidocaine was applied. Following aseptic preparation of the skin and probe, a medium-frequency curvey USG transducer was first placed in the midline to visualize the transverse projection of the first lumbar (L1) vertebra, then moved 2.5 cm laterally in the parasagittal plane, after imaging the transverse process, in-plane spreading was injected. Hydrodissection was achieved on the TP of L1 by using a 5 cm, 21G peripheral nerve block needle just below the erector spina muscle with real-time imaging of the substance. Afterwards, a unilateral injection of 15 ml at T12 and L1 levels was applied to each segment with the needle directed at two different angles from the same insertion point.
15724070|NCT05073042|Behavioral|Morning exercise goal|Participants will be instructed to walk at a moderate intensity for at least 15 continuous minutes between 5 AM and 10 AM each day.
15724071|NCT05073042|Behavioral|Evening exercise goal|Participants will be instructed to walk at a moderate intensity for at least 15 continuous minutes between 5 PM and 10 PM each day.
15724072|NCT05073042|Behavioral|Time of choice exercise goal|Participants will be instructed to walk at a moderate intensity for at least 15 continuous minutes at a time of their choice each day. This time can change day-to-day.
15724073|NCT05073029|Other|nutrition program and modification of physical activity|nutrition program developed by a gastroenterologist-nutritionist and modification of physical activity (8000-10000 steps daily)
15724074|NCT05073029|Dietary Supplement|synbiotic (Fructooligosaccharides+Lactobacillus rhamnosus GG ATCC 53103, 4.0х109 colony forming units - CFU)|one synbiotic sachet (3g), BID, for 3 month traetment
15724075|NCT05073029|Dietary Supplement|vitamin D3|vitamin D3, oral, 2000IU BID, for 3 month treatment
15724091|NCT05072951|Diagnostic Test|Urine Biomarker for Kidney Transplant Rejection|Biomarker for active kidney transplant rejection.
15724099|NCT05072873|Other|normal saline|temporary uterine packing with gauze of the dimensions soaked with 2 gm placebo to tranexamic diluted in 60ml saline acid
15724100|NCT05072860|Drug|Topical tranexamic acid|temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid
15724101|NCT05072860|Other|: normal saline|temporary uterine packing with gauze of the dimensions soaked with placebo to 2 gm tranexamic diluted in 60ml saline acid
15724102|NCT05072834|Procedure|Upper Gastrointestinal Endoscopy|"Procedure Upper gastro-intestinal endoscopic procedure involves collection of intestinal samples and it can be helpful in identifying the causes of malnutrition. Upon parental approval, the child along with two relatives will be provided transportation to Karachi, accommodation and the compensation for their time and expenses.
~For this procedure the child will be admitted to the hospital a day before the procedure till one day after the procedure. This procedure takes 30 minutes, requires general anesthesia and involves insertion of a flexible tube with a small TV camera and a light on one end and an eyepiece on the other. The endoscope will allow the doctor to examine the inside of certain tube-like structures in the body. Some tissue samples for laboratory testing will be taken."
15724103|NCT05072821|Drug|Botulinum Toxin Type A Injection [Botox]|After the whole surgical procedures of keloid revision are done, the participants will receive Botulinum Toxin type A (BTA) injection. The investigators split the scar into the right side and the left side. BTA and 0.9% saline, respectively, are used for the two arms of the study. Vials containing 100 units of BTA (BotoxⓇ, Allergan) are mixed with 2mL 0.9% injectable saline. The injection depth will be the intradermal layer. Injections will be performed with a 30-gauge needle and 1 mL syringe. Just before skin closure, the entire scar was treated, with sides randomized to receive treatment with either BTA or 0.9% normal saline. The dosage is 8 units / cm based on aforementioned studies. The maximal dose won't exceed 100 units.
15724104|NCT05072821|Drug|0.9% Sodium Chloride Injection|After the whole surgical procedures of keloid revision are done, the participants will receive 0.9% saline injection. The investigators split the scar into the right side and the left side. BTA and 0.9% saline, respectively, are used for the two arms of the study. Only 0.9% saline is injected on the control side. The injection depth will be the intradermal layer. Injections will be performed with a 30-gauge needle and 1 mL syringe. Just before skin closure, the entire scar was injected, with sides randomized to receive treatment with either BTA or 0.9% normal saline. The dosage is 0.16 mL / cm.
15724105|NCT05072808|Other|View PACCI-ED and referral recommendations|Results of parent completed PACCI-ED and referral recommendations
15724106|NCT05072795|Behavioral|Trier Social Stress Task (TSST)|The TSST is a standardized psychological stress challenge which provokes a stress response in a laboratory setting. During the task, saliva samples will be collected for hormone testing along with physiological and subjective measures.
15724107|NCT05072782|Drug|Infliximab CT-P13|"Stratification 1: Infliximab-CT-P13
~Stratification 2: Infliximab-CT-P13 in combination with immunosuppressors"
15724108|NCT05072782|Drug|Immunosuppressors (Thiopurines or Methotrexate)|"Stratification 1 : No treatments
~Stratification 2 : Immunosuppressors at same dose"
15724109|NCT05072769|Dietary Supplement|Date Fruit|Within the first hour after birth, 100gr (5-6 pieces) dates will be eaten.
15724110|NCT05072756|Other|Applying a questionnaire|The participants have to answer a questionnaire addressing their opinion on menopausal hormone replacement therapy
15724112|NCT05072730|Device|Super high-pressure balloon (OPN NC)|Strategy of super high-pressure balloon angioplasty after unsuccessful lesion preparation with conventional NC balloon angioplasty. Following lesion preparation, stenting will be performed in the same setting using a latest-generation DES. Post-dilatation will be mandatory in all patients and will be performed with a super high-pressure balloon.
15724113|NCT05072730|Device|Intravascular lithotripsy (IVL)|Strategy of IVL after unsuccessful lesion preparation with conventional NC balloon angioplasty. Following lesion preparation, stenting will be performed in the same setting using a latest-generation DES. Post-dilatation will be mandatory in all patients and will be performed with a conventional NC balloon.
15724114|NCT05072717|Procedure|Perfusion with Indocyanine green|Infusion of Indocyanine green to determine perfusion in meniscal tear tissue.
15724115|NCT05072704|Drug|Sufentanil|Pre-operative injection of sufentanil 10µg in 2ml of normal saline on induction of anesthesia + per-operative injection of sufentanil 5µg in 1ml of normal saline during the surgery if needed.
15724116|NCT05072704|Drug|Dexmedetomidine|Pre-operative infusion of dexmedetomidine 1µg/kg in 100ml of normal saline before surgery + per-operative infusion of dexmedetomidine 0.4 µg/kg in 100ml of normal saline during the surgery if needed.
15724117|NCT05072691|Diagnostic Test|CSF immunoglobulin (Ig) free light chains (FLC) dosage|CSF immunoglobulin (Ig) free light chains (FLC) dosage in the peripheral blood and cerebrospinal fluid.
15724118|NCT05072665|Device|HIGH ECHOENDOSCOPY WITH THE FAST PROCEDURE|HIGH ECHOENDOSCOPY WITH THE FAST PROCEDURE
15724119|NCT05072652|Other|Neuromuscular Electrical Stimulation|Participants in this group will perform twice daily neuromuscular electrical stimulation training sessions of the quadriceps muscles (specifically, the vastus lateralis and rectus femoris) or the immobilized left leg.
15724120|NCT05072652|Other|Action Observation + Mental Imagery|Participants in this group will perform daily action observation + mental imagery training via video and audio recordings.
15724122|NCT05072626|Combination Product|high MCT formula|Alfaré(Nestlé Health Science China, including 39% of MCT) with breast milk (or infant formula). Alfaré can be fed with moderate concentration(3.45 tablespoons of 90ml water - 4 tablespoons of 90ml water), and the total energy can be increased by 7.3-16.8kcal/kg/day.
15724123|NCT05072626|Dietary Supplement|MCT powder|MCT supplement 1-2g/kg/day combined with breast milk (or infant formula), the total energy can be increased by 7.3-14.6kcal/kg/day.
15724124|NCT05072613|Other|Malaria screening|Participants are screened for malaria and a dried blood spot is collected from malaria positive cases
15724126|NCT05072587|Behavioral|Plant-based diet with no oxysterols|This group will be given 3 prepared plant-based meals a day with macronutrient content: 60% of calories from carbohydrates, 15% protein, and 25% fat. Calories: 25 kcal/kg ideal body weight (IBW). The goal is weight maintenance, but weight loss may occur. 1-5% weight loss will be acceptable and not deemed a potential confounder. Participants will be screened for food allergies and intolerances prior to receiving their research diets. All meals will include culturally familiar foods to enhance adherence. The dietary intervention will be conducted over 4 3-month periods (12 months). Meals will be packaged labeled and distributed to participants once per week. Participants will consume their meals at home.
15724127|NCT05072587|Behavioral|Standard ADA Diet (SADA)|This group will be given 3 prepared meals a day with macronutrient content: 60% of calories from carbohydrates, 15% protein, and 25% fat. Calories: 25 kcal/kg ideal body weight (IBW). The goal is weight maintenance, but weight loss may occur. 1-5% weight loss will be acceptable and not deemed a potential confounder. Participants will be screened for food allergies and intolerances prior to receiving their research diets. All meals will include culturally familiar foods to enhance adherence. The dietary intervention will be conducted over 4 3-month periods (12 months). Meals will be packaged labeled and distributed to participants once per week. Participants will consume their meals at home.
15724129|NCT05072561|Diagnostic Test|Sentinel lymph node scintigraphy|"During the surgery, right after the identification of the primary, 18-37 MBq of 99mTc-Nanocolloids in two ml will be injected at four peritumoral locations. After a brief waiting time (5-10'), the thoracic surgeon will perform the clinical intervention, including the lobectomy (the injection sites will be resected alongside the tumour) and lymphadenectomy, according to the best clinical practice. All the excised lymph nodes will be ex vivo counted using a gamma probe: those with a detectable activity (at least 10% of the hottest lymph node) will be considered as SLN. Thereafter, the mediastinum will be scanned using the gamma probe and a handheld gamma-camera (the latter will not be employed in case of robotic-assisted surgery); any further source of radioactivity will be investigated and, should further lymph nodes be identified, these will be also resected and classified in SLN or non-SLN, based on ex vivo activity."
15724130|NCT05072548|Behavioral|The ABCs of SLEEPING|"The intervention is comprised of three components. The first is a sleep check-in which is a questionnaire that is evidence based and evaluates what areas of sleep parents can work on. The second component is the sleep report which summarizes to the parent what areas they're doing well in (i.e., within the ABCs of SLEEPING mnemonic described above) and what areas they can improve on. The third component of this intervention are the sleep tips which are sleep recommendations that are customized based on the identified areas of sleep the parents are suggested to work on."
15724131|NCT05072535|Drug|HA121-28 tablet B|HA121-28 tablet B 200 mg
15724132|NCT05072535|Drug|HA121-28 tablet A|HA121-28 tablet A 200 mg
15724133|NCT05072522|Drug|SKLB1028|SKLB1028 capsules, oral, once daily in continuous 28-day cycles
15724134|NCT05072470|Device|Roger microphone|Roger (model name) microphone
15724135|NCT05072457|Device|Roger microphone|Roger microphone transmitter
15724138|NCT05072431|Other|SVVR training program|The SVVR training program is consisted of five scenarios with tasks. Before the SVVR training implementation, the research team provided 10-minute orientation session to introduce the purpose of the training. The 3D VR professional taught the participants how to wear the 3D VR helmets and select the VR scenes, so that the participants could practice multiple times.
15724139|NCT05072405|Drug|Simvastatin 20 mg (Zocor®, MSD)|Simvastatin 20 mg given once alone, once with green tea extract and once with soy isoflavones extract.
15724140|NCT05072405|Drug|rosuvastatin 10 mg (Crestor®, Astra Zeneca)|rosuvastatin 10 mg are given once alone, once with green tea extract and once with soy isoflavones extract.
15724141|NCT05072392|Device|Foley catheter|"Using a 16G Foley catheter to cover the tip of the endotracheal tube as it passes through the nose. This is done in comparison to the standard practice of directly passing an endotracheal tube through the nose without a cover.
~Both groups use warmed endotracheal tubes and the use of topical vasoconstrictor (4 sprays of 0.1% xylometazoline to each nare)."
15724142|NCT05072379|Device|colostomy self-care app|The study will use mixed methods as the study design in which content analysis will be used to identify the content suited for the App based on interviews with participants. A systematic research and development process will be utilized to design the text, videos, and images in the App's simulations to provide accurate, consistent, and complete knowledge of the skills needed for colostomy self-care and contending with any potential emergency.
15724143|NCT05072353|Device|SEFFICARE|"The SEFFI is a 5-step technique:
~Preparation: the lower/lateral abdomen is chosen as the donor site.
~Anesthesia: the donor site is injected with a local anesthetic.
~Harvesting: a 0.8 mm or 0.5 mm cannula connected to a 10-ml VacLok® syringe is used to harvest the adipose tissue. The total amount of the harvested tissue could vary from 10 to 30 mL.
~Washing: The syringe containing the lipoaspirate tissue is immediately filled with sterile physiological solution. After some minutes the syringes in the decanting stand will show a separation by the gravity of the tissue (top) from the physiological solution (bottom).
~Fluidification: the syringe containing the adipose tissue should be connected to an empty 10 ml syringe. After pushing the tissue about 3 times from one syringe to the other, a good fluidification of the tissue is obtained.
~The resulting tissue (2.5 mL per syringe) is ready for grafting the amputation wound."
15724144|NCT05072340|Behavioral|Resilience Skills Enhancement (RISE)|The RISE training was developed according to theory, empirical evidence and contextual information. The contents, components, pedagogy, and technical elements of RISE is established based on the resilience theory (Szanton & Gill, 2010) systematic review and meta-analysis, meta-synthesis, and qualitative study (Ang et al., 2021). Ethical and quality standards was assessed using the Health on the Net code of conduct and the Health-Related Website Evaluation Form respectively. The overall rating of the designed RISE is more than 75% of the total possible points to ensure quality of website by three research team members.
15724145|NCT05072327|Procedure|Mohs surgery|Mohs surgery of eyelid
15724146|NCT05072327|Procedure|cryotherapy|cryotherapy of eyelid
15724147|NCT05072314|Drug|lidocaine 2% and 10%|"Lidocaine infusion:
~Commencing with an intravenous bolus after induction of anaesthesia (2.5 mg/kg/hr),
~Followed by a 2% lidocaine intravenous infusion for the duration of surgery (3.33 mg/kg/hr)
~A post-operative subcutaneous 10% lidocaine infusion for up to 24 hours thereafter (2.22 mg/kg/hr)."
15724148|NCT05072314|Drug|Placebo|"Saline infusion:
~Commencing with an intravenous bolus after induction of anaesthesia (2.5 mg/kg/hr),
~Followed by a 2% lidocaine intravenous infusion for the duration of surgery (3.33 mg/kg/hr)
~A post-operative subcutaneous 10% lidocaine infusion for up to 24 hours thereafter (2.22 mg/kg/hr)."
15724149|NCT05072301|Behavioral|Contingency Management|The treatment group will receive a onetime offer of $80 (a reactive carrot) to forego all abstinence (contingency management) reward payments in the future.
15724150|NCT05072301|Behavioral|Control|The control group will receive contingency management payments and other monetary benefits for completing the trial.
15724151|NCT05072288|Other|Remote activity program|Participant will have to do exercise at home everyday (15min/day)
15724152|NCT05072262|Drug|Nepafenac Ophthalmic|Topical nepafenac (Nevanac) 3 mg/ml
15724153|NCT05072262|Drug|Dexamethasone Ophthalmic|Topical dexamethasone 1 mg/ml (Spersadex)
15724154|NCT05072249|Drug|Naloxone|Take Home Naloxone for reversing opioid overdose
15724155|NCT05072236|Procedure|cough score|"cough score = cough severity x times Cough severity was graded on a 5-point scale: minimal cough, 1 point; moderate cough, 2 points; severe cough, 3 points; bouts of coughing, 4 points; and series of bouts of coughing, 5 points.
~Cough score is the accumulated scores during bronchoscopic spray of local anesthetics"
15724156|NCT05072223|Procedure|Pericapsular nerve group block|A new nerve block guided by ultrasound that aims to block articular branches of the shoulder.
15724157|NCT05072223|Procedure|Interscalene block|A common and rapid-onset nerve block method guided by ultrasound for pain control of patients undergoing shoulder surgery.
15724159|NCT05072197|Device|Mobile device as a support tool for the treatment of women with breast cancer undergoing chemotherapy|This study will develop a Mobile device application providing medical care information and social support for breast cancer women during their chemotherapy treatment to help them receive individually tailored information related to chemotherapy and support from healthcare professionals and peers.
15724160|NCT05072184|Procedure|ESP block|ESP block group who will receive preoperative US-guided bilateral ESP block with 20 ml of bupivacaine 0.25% on each side
15724163|NCT05072145|Other|Telemedicine|Receiving care in a tele-ED hospital
15724166|NCT05072119|Device|Device implantation|Implantation of single chamber, dual chambers or triple chambers PM/ICD
15724167|NCT05072106|Drug|Lurbinectedin|3.2 mg/m² as a 1-hour i.v. infusion on Day 1.
15724168|NCT05072106|Drug|Bosentan|Bosentan: 125 mg (one film-coated tablet of 125 mg) orally (p.o.) twice daily in the morning and in the evening during the prior five consecutive days before the day of lurbinectedin infusion (Day 1), and once daily on Day 1 (before lurbinectedin infusion).
15724174|NCT05072067|Procedure|the sleeve gastroplasty with the endoscopic system Overstich SX|the sleeve gastroplasty with the endoscopic system Overstich SX
15724178|NCT05072028|Drug|[14C]DBPR108|[14C]DBPR108, single dose of 100 mg (radioactivity of 150 µCi), oral
15724179|NCT05072002|Other|no intervention / observational study|no intervention / observational study
15724180|NCT05071989|Behavioral|Sleep Education|A single-blind school- based randomized controlled design
15724182|NCT05071963|Device|Treatment of Intracranial Aneurysms|Embolization of aneurysms using the Pipeline™ Flex Embolization Device with Shield Technology™
15724183|NCT05071950|Other|Control period|"first 7 days, participants consumed normal meal during iftar (breaking the fast at sunset)
~participants did not allow to have added sugar/ sweetness drinks before the iftar meal
~flash continuous glucose monitoring system (FreeStyle Libre Pro) was used to measure the glucose
~food diary was used to record the iftar meal"
15724184|NCT05071950|Dietary Supplement|D-allulose period|"[started after 7 days of control period],
~participants continued with D-allulose period for 7 days continuously
~participants consumed 8.5 g of D-allulose, (dissolve in plain water normal) before start the iftar meal
~participants did not allow to have added sugar/ sweetness drinks before the iftar meal
~flash continuous glucose monitoring system (FreeStyle Libre Pro) was used to measure the glucose
~food diary was used to record the iftar meal
~a questionnaire (multiple choice anwers) was used to record the side effects of D-allulose"
15724185|NCT05071937|Drug|ZEN003694|ZEN003694 has shown promising activity in the treatment of solid tumors and hematologic (blood) cancers by reducing the multiplication of cancer cells.
15724186|NCT05071937|Drug|Talazoparib|Talazoparib kills cancer cells by inhibiting and trapping the enzyme PARP, which is known to be involved in the development of many types of cancers.
15724187|NCT05071924|Behavioral|PLH Teens Original: In-person PLH programme for parents and teens by community-based workers|This in-person intervention is delivered over 14 sessions (10 joint parent and teen sessions and 4 separate parent and teen sessions).
15724188|NCT05071924|Behavioral|PLH Teens Hybrid: Hybrid delivery for parents and teens by facilitators|The hybrid intervention delivered over 12 sessions (8 sessions delivered via WhatsApp groups to parents only and 4 sessions delivered in-person to parents and teens together).
15724189|NCT05071911|Procedure|TAD (Targeted Axillary Dissection)|Dual agent SLNB + resection of proven lymph nodes metastasis marked with clip at diagnosis
15724190|NCT05071898|Drug|Semaglutide Pen Injector [Ozempic]|Participants will receive subcutaneously injected semaglutide (0.25 mg/wk) for 4 weeks followed by semaglutide (0.5 mg/wk) for an additional two weeks.
15724191|NCT05071885|Other|games based exercise|Range of motion and strengthening exercises
15724192|NCT05071872|Device|Atherectomy/Thrombectomy|Percutaneous transluminal removal of thrombotic occlusion in arteriovenous graft
15724193|NCT05071859|Other|Whole Genome Sequencing|Saliva collection and request for banked bood and tumor samples for sequencing
15724194|NCT05071859|Other|Questionnaire Administration|Study questionnaire will include modules that collect information on maternal reproductive history, exposure to known teratogens, medical history, and previous genetic testing.
15724195|NCT05071846|Other|MVX-ONCO-2|"One administration of MVX-ONCO-2 (or vaccination) consists of the implantation of 2 capsules containing MVX-2 cells and 1 injection of 4 × 10^6 lethally irradiated autologous tumor cells. Tumor cells will have prealably been harvested from the participant through a surgical procedure.
~A full treatment course with MVX-ONCO-2 consists of a total of 6 vaccinations: 4 vaccinations 1 week apart, followed by 2 boosters 2 weeks apart. Capsules are removed 1 week after implantation."
15724196|NCT05071833|Dietary Supplement|Peppermint oil.|Peppermint oil.
15724197|NCT05071833|Other|Placebo|Placebo
15724198|NCT05071820|Other|Health U mobile application|Health U mobile application delivers daily microlearning modules and the health coach interactions within the Health U application
15724199|NCT05071820|Other|National Diabetes Prevention Program|CDC recognized National DPP that follows a set curriculum with modules delivered over 12 months
15724202|NCT05071794|Drug|Propofol|Antiemetic effect of propofol
15724203|NCT05071794|Drug|saline 0.9%|Placebo
15724204|NCT05071781|Drug|Corticotropin-release hormone|intravenous CRH (100 µg)
15724205|NCT05071781|Drug|Corticotropin-release hormone|a bolus dose (CRH 100 µg or placebo) will be administered, followed by a continuous infusion (CRH 1 µg/kg/h or placebo)
15724206|NCT05071768|Behavioral|Focused ACT|Brief acceptance and commitment therapy
15724208|NCT05071742|Genetic|2ml peripheral venous blood was collected to detect genetic genes|"Extraction of whole genome DNA: 2 mL of peripheral fasting venous blood was extracted, and edTA disodium was anticoagulant.The whole-genome DNA was extracted strictly in accordance with the instructions of the blood genomic DNA extraction kit (Beijing Tiagen Biochemical Technology Co., LTD., China), and the DNA concentration and purity were detected by nanodrop-1000 spectrophotometer (Thermo, USA). The DNA was diluted to 10 ng/μL and stored in a refrigerator at -80℃ for future use.
~(2) Primer design and synthesis: (3) Gene polymorphism detection 4) Resin purification 5) Spot chip and mass spectrometry detection"
15724210|NCT05071716|Drug|Rifaximin SSD|Rifaximin Solid Soluble Dispersion Immediate Release Twice Daily
15724211|NCT05071716|Drug|Placebo|Placebo Twice Daily
15724212|NCT05071703|Drug|Trilaciclib|"Carboplatin combined with Etoposide (ES-SCLC patients)
~plus Topotecan (second/third line ES-SCLC patients)"
15724213|NCT05071677|Procedure|Discussion|Participate in treatment planning meeting
15724214|NCT05071677|Other|Interview|Participate in interview
15724215|NCT05071677|Other|Survey Administration|Complete survey
15724216|NCT05071664|Drug|Guselkumab|Guselkumab will be administered as a SC injection.
15724217|NCT05071664|Drug|Golimumab|Golimumab will be administered as a SC injection.
15724218|NCT05071664|Drug|Placebo|Placebo will be administered as a SC injection.
15724219|NCT05071638|Biological|autologous cord blood mononuclear cells|preterm neonates less than 28 weeks who suffer BPD and also stored cord blood are assigned to receive intravenous autologous cord blood mononuclear cells infusion (5×107cells/kg).
15724220|NCT05071625|Procedure|percutaneous vertebroplasty|percutaneous vertebroplasty under combined CT/fluoroscopy guidance for non-union after posterior fixation performed for a traumatic non-neurologic thoraco-lumbar vertebral fracture.
15724221|NCT05071612|Drug|AD109|Oral administration at bedtime
15724222|NCT05071612|Drug|AD504|Oral administration at bedtime
15724223|NCT05071612|Drug|Atomoxetine Hydrochloride|Oral administration at bedtime
15724224|NCT05071612|Drug|Placebo|Oral administration at bedtime
15724227|NCT05071573|Other|Optimised electronic patient records|Viral load champions trained in the monitoring of patient on antiretroviral therapy to aid prompt identification of virological failure and institution of appropriate clinical management
15724228|NCT05071560|Other|Combined exercise training|"Before the intervention, these women will undergo an evaluation of cardiorespiratory fitness, functional fitness, psychological status and a physiatry assessment. A consent form is signed before the start.
~The physical exercise intervention was planned based on the recommendations of the American College of Sports Medicine for cancer survivors (ACSM 2019), with two supervised combined training sessions (mobility, aerobic training, strength and flexibility training) planned, and one unsupervised aerobic training session per week, interspersed with at least one rest day in between, for 8 weeks. The intensity will be individualized and defined based on the initial assessment. The structure of the training plan was based on the FITT-VP principles (frequency, intensity, time, type, volume and progression) recommended by the ACSM (2019)."
15724229|NCT05071547|Behavioral|Guided internet-delivered acceptance and commitment therapy (ACT)|ACT builds on cognitive behavioral therapy (CBT), and includes methods for experiential learning and focus on psychological flexibility
15724230|NCT05071547|Other|Interdisciplinary Pain Rehabilitation Program (IPRP)|Multimodal treatment where physio therapists, occupational therapists, psychologists and physicians give synchronized treatments to raise physical and psychological function and promote return to work
15724231|NCT05071521|Other|The Body Project: A Dissonance-Based Eating Disorder Prevention Intervention|The Body Project is a a selective dissonance-based prevention program that targets women with body image concerns. It has been developed with University and similar populations in mind, making it appropriate to the current research.The Body Project is based on a protocol, and aims to create cognitive dissonance that encourages participants to reduce pursuit of the thin-ideal. It involves the use of a scripted manual, covering four interactive weekly sessions. These involve role play, behavioural, verbal and written exercises.
15724232|NCT05071495|Device|Smartphone application|"Smartphone application named Signal, which connects patients and health providers"
15724233|NCT05071482|Drug|Flumatinib|Flumatinib 600 mg qd will be given orally along with combination chemotherapy starting day 8 of induction chemotherapy. Flumatinib will be given continuously (if it's tolerable) for 2 years since achievement of complete remission (CR) as part of consolidation chemotherapy and maintenance therapy. Patients can receive allogeneic hematopoietic stem cell transplantation (HSCT),or patients in whom MCR was achieved within 3 months after treatment and continued until transplantation can receive autologous HSCT whenever possible during their first CR. Otherwise, they will finish the consolidation and maintenance chemotherapy.
15724234|NCT05071482|Drug|Imatinib|Imatinib 600 mg qd will be given orally along with combination chemotherapy starting day 8 of induction chemotherapy. Imatinib will be given continuously (if it's tolerable) for 2 years since achievement of complete remission (CR) as part of consolidation chemotherapy and maintenance therapy. Patients can receive allogeneic hematopoietic stem cell transplantation (HSCT),or patients in whom MCR was achieved within 3 months after treatment and continued until transplantation can receive autologous HSCT whenever possible during their first CR. Otherwise, they will finish the consolidation and maintenance chemotherapy.
15724235|NCT05071469|Other|Kinesiotaping|Patients were instructed to keep the tape on for 72 hours and then to remove it and to come back to the clinic for second intervention. KT repeated every four days, twice times in two weeks. Two strips were used for KT procedure. The first strip was a Y-strip for inhibition of the supraspinatus and was applied from its insertion to origo with paper-off tension. This strip was applied with the patient in a position of combining contra-lateral cervical side bending and the arm reaching behind the back. The second strip was an I-strip with Y shape at the end of tape. It was applied from the coracoid process around the posterior deltoid with approximately 50% to 75% tension and downward pressure applied for a mechanical correction. For this technique, the shoulder was externally rotated while at the side and then moved into flexion and slight horizontal adduction as the end of the tape was applied with no stretch.
15724236|NCT05071469|Other|Mulligan Mobilization Technique|The patient performed the offending movement while the glide was sustained. This movement should now become pain-free. Passive overpressure could be given by the patient at the end of the newly available range using his/her other hand. The hand of the physiotherapist should also move along with the movement in order to sustain the glide along the treatment plane. When the patient moved his/her shoulder, rotation of the scapula allowed upward. MT was applied 10 repetitions for each session, 30 sec rest period between sets, 4 sessions with 24 hours between 2 treatment seasons.
15724238|NCT05071443|Other|Negative pressure wound therapy (NPWT)|"The therapeutic intervention being tested is the use of a negative pressure wound therapy (NPWT) device. Several medical devices are currently being used and are based on the same principle. They involve applying negative pressure, generally between -100 and -150 mmHg, to a wound using a dressing (mostly a polyurethane foam dressing with hydrophobic pores), which hermetically covers the wound's surface and is connected to a container for collecting the fluids drained off. These devices are widely available and used to treat post-operative wounds.
~Duration of treatment: the use of NPWT will be maintained until the recovery of the skin has been achieved by the skin graft. An average duration of 3 weeks' treatment is expected in the intervention group."
15724239|NCT05071443|Other|Conventional dressing|"Conventional dressings will be performed from randomization to skin grafting and applied every day based on the methods normally used in the participating centres, and also until the recovery of the skin has been achieved by the skin graft.
~This generally involves local care provided on a daily basis, ensuring gentle mechanical and chemical debridement by covering the wound with alginate type or other dressings, according to the condition of the wound. The methods used to apply these conventional dressings will be recorded."
15724240|NCT05071430|Drug|HB-01|HB-1 will be supplied as a dual active pharmaceutical ingredient tablet.
15724241|NCT05071430|Drug|Placebo|HB-1 matched placebo
15724242|NCT05071417|Drug|Semaglutide|Usual treatment with semaglutide. Dose 0.5 - 1mg weekly, subcutaneous, weekly
15724243|NCT05071391|Procedure|Roux-en-Y gastric bypass|"Gastric bypass, also called Roux-en-Y gastric bypass, is a type of weight-loss surgery that involves creating a small pouch from the stomach and connecting the newly created pouch directly to the small intestine. After gastric bypass, swallowed food will go into this small pouch of stomach and then directly into the small intestine, thereby bypassing most of your stomach and the first section of your small intestine.
~Gastric bypass is one of the most commonly performed types of bariatric surgery. Gastric bypass is done when diet and exercise haven't worked or when you have serious health problems because of your weight."
15724244|NCT05071378|Behavioral|Our Family, Our Voices|Many Men, Many Voices (3MV) is a seven-session, group-level intervention developed to prevent HIV and sexually transmitted diseases (STDs) among black men who have sex with men (MSM) who may or may not identify themselves as gay. The intervention addresses factors that influence the behavior of black MSM: cultural, social, and religious norms; interactions between HIV and other STDs; sexual relationship dynamics; and the social influences that racism and homophobia have on HIV risk behaviors. Our Family, Our Voices seeks to create an adaptation of Many Men, Many Voices specifically tailored to young people who are members of the house ball community by incorporating elements of family support and resilience afforded to participants in the intervention.
15724245|NCT05071365|Other|Early access to virtual resources|Single arm study. Participants are given access to self help videos for the management of plantar fasciitis while they are on the waiting list
15724246|NCT05071352|Drug|Nefopam|Nefopam will be administered as an initial dose of 20 mg IV dose infused over 15 minutes then, as continuous infusion of 5 mg/hr for 24 hours.
15724247|NCT05071352|Drug|Standard of care in the ICU for assessment and management of pain, sedation, and delirium.|In our protocol we use analgiosedation approach (an opioid is used before a sedative to reach the sedation goal), targeting light sedation using richmond agitation sedation scale (RASS) score -1 to 0, and assess delirium using confusion assessment method for the ICU (CAM-ICU).
15724248|NCT05071339|Drug|Ganirelix Acetate, Cetrolix Acetate|3-6 days of 0.25mg GnRH antagonist starting day 2-3 of the menstrual cycle prior to the administration of the original protocol.
15724249|NCT05071326|Behavioral|Nurse-led health coaching|This project is an 6-month program providing an initial 2-month intensive evaluation and personalized virtual individual health coaching experience that is designed to prepare and equip the participant for improved self-care capacity, motivational insight, health-related problem solving and decision-making. This intensive period will then be followed by monthly 30-minute Nurse Coach assessment and individual coaching 'check-in' virtual visits, continued use of the electronic platform tools and health tracking system, and access to group 'virtual coaching' on tailored topics of interest to the cohort.
15724253|NCT05071300|Drug|ION-682884|ION-682884 will be administered by SC injection.
15724254|NCT05071287|Other|mHealth + low-fat diet|A restricted total calorie and reduced total fat consumption.
15724255|NCT05071287|Other|mHealth + low-carb/ketogenic diet|A low-carb/ketogenic diet
15724256|NCT05071274|Device|Skinpen Prescision System|Skinpen Precision is an automated nonsurgical micro needling device designed for use by licensed health care practitioners or individuals directed by practitioners. The device incorporates a sterile Microneedle cartridge and Biosheath for single use only.
15724257|NCT05071261|Diagnostic Test|Hepatitis C Virus Screening|1-2 Blood Screenings for Hepatitis C Virus
15724258|NCT05071248|Device|VEMO (Reactive Robotics GmbH)|The robot used for early mobilization is able to verticalize the patients in their bed without transfer and to generate a movement of the legs that measures and supports the patients' own movement. The device meets the requirements for mobilizing critically ill patients in an intensive care unit, maintaining hygiene standards and providing the best possible support for the patient's own movement.
15724259|NCT05071235|Device|LG1 (LLLT group 1)|Application of LLLT (low-level laser therapy) AsGa 904 nm 10 J/cm².
15724260|NCT05071235|Device|LG2 (LLLT group 2)|Application of LLLT (low-level laser therapy) AsGa 904 nm 8 J/cm².
15724261|NCT05071235|Device|LG3 (LLLT group 3)|Application of LLLT (low-level laser therapy) AsGa 904 nm 4 J/cm².
15724262|NCT05071235|Device|CG (control group)|Application of placebo LLLT (low-level laser therapy), that is, with the device turned off.
15724263|NCT05071235|Procedure|Dressing|Application of Helianthus annuus oil dressing.
15724264|NCT05071222|Genetic|ARTEGENE drug product|Each patient will receive a single intravenous infusion of ARTEGENE drug product at D0.
15724265|NCT05071209|Drug|Elimusertib|Given PO
15724270|NCT05071170|Behavioral|Ad libitum energy intake|Investigate post meal satiety and subsequent post meal energy intake according to degree of food processing and eating behaviour
15724271|NCT05071157|Behavioral|echocardiography|"speckle tracking echocardiography
~evaluation of cardiac variability by recording heart rate as several hours (POLAR watch)
~bioimpedance
~blood test for biological assays (metabolomic analysis)"
15724272|NCT05071131|Dietary Supplement|Inulin|2 sachets à 15 grams daily for 28 days
15724273|NCT05071131|Dietary Supplement|Placebo|2 sachets à 15 grams daily for 28 days
15724274|NCT05071118|Drug|Pregabalin 150mg|pregabalin patients (group P) received capsules containing 150mg of pregabalin in the ward then transferred to OR to receive spinal anesthesia before surgery
15724275|NCT05071118|Drug|Placebo|The patients received placebo capsules in the ward Then transferred to OR to receive spinal anesthesia before surgery .
15724276|NCT05071105|Radiation|Stereotactic Body Radiation Therapy|In every group, the dose is prescribed at the edge of the PTV. To be approved, 95% of the PTV will be conformally covered by the prescription isodose surface and 99% of PTV will receive a minimum of 90% of the prescription dose.
15724277|NCT05071092|Behavioral|Dietary counselling|Participants assigned to the intervention group will receive coaching from a dietitian to improve adherence to the Dutch dietary guidelines. Several behavioral change techniques will be used.
15724278|NCT05071079|Biological|An inoculum of malaria parasitised red blood cells with whole dose blood-stage inoculum|An inoculum of malaria parasitised red blood cells reconstituted in 0.9% normal saline, to a total volume of 5 mL; challenge with whole dose blood-stage inoculum (neat)
15724279|NCT05071079|Biological|An inoculum of malaria parasitised red blood cells with 1:5 dilution blood-stage inoculum|An inoculum of malaria parasitised red blood cells reconstituted in 0.9% normal saline, to a total volume of 5 mL; challenge with 1:5 dilution blood-stage inoculum
15724280|NCT05071079|Biological|An inoculum of malaria parasitised red blood cells with 1:10 dilution blood-stage inoculum|An inoculum of malaria parasitised red blood cells reconstituted in 0.9% normal saline, to a total volume of 5 mL; challenge with 1:10 dilution blood-stage inoculum
15724281|NCT05071079|Biological|An inoculum of malaria parasitised red blood cells with 1:20 dilution blood-stage inoculum|An inoculum of malaria parasitised red blood cells reconstituted in 0.9% normal saline, to a total volume of 5 mL; challenge with 1:20 dilution blood-stage inoculum
15724282|NCT05071066|Other|ADHD+|"The group-based intervention is designed to reduce participants' ADHD and related symptoms. The content of the treatment will follow an established manual which is developed by an expert group comprised of psychiatrists and clinical psychologists. Core treatment components include internet use/addiction intervention, cognitive training, emotion management, social skills training, occupational training, emotion support/befriending, parenting training, and career guidance.
~The main intervention lasts for 3 months, and the booster intervention lasts for another 3 months. The post- intervention assessments (3-month [T1], and 6-month [T2]) will be administered to all participants. During the period of intervention, all participants shall be clean from other forms of interventions to reduce any other possible confounders."
15724283|NCT05071053|Drug|Ramucirumab (CYRAMZA®)|"Pharmaceutical Form: Concentrate for solution for infusion
~Route of Administration: Intravenous Infusion"
15724284|NCT05071053|Drug|Tusamitamab ravtansine (SAR408701)|"Pharmaceutical Form: Concentrate for solution for infusion
~Route of Administration: Intravenous Infusion"
15724285|NCT05071040|Behavioral|Home-based physical activity|Participants will follow a strength exercise program
15724286|NCT05071027|Other|Endovascular Neurosurgery|Custom Dual Antiplatelet Therapy reminders for patients receiving endovascular treatment of cerebral unruptured aneurysms. The app utilized to generate reminders is available on the Apple app store.
15724289|NCT05071001|Procedure|MRI|"This assessment will be planned in the year after the consent signAll patients will have one brain MRI performed in Henri Mondor Hospital on a 3T MR unit (Skyra, Siemens, Erlangen). The procedure will include:
~a 3D-FLAIR imaging
~a morphometric study based on a 3DT1 MPRAGE gradient echo sequence (TR / TI / TE = 2300/900 /2.9 ms)
~an analysis of the anatomic connectivity of the patient's brain assessed using a 1.5mm isotopic DTI with a high number of directions (HARDI / 65 directions / b=1500s/mm2).
~An evaluation of neuronal dysfunction using MR Spectroscopy. Spectroscopic data will be collected using a 2D CSI laser with a short TE technique.
~Magnetization transfer imaging providing information about integrity of membranes."
15724290|NCT05070988|Other|Semi-structured interview|Semi-structured interview with the investigating doctor of the study lasting 30 minutes to an hour
15724291|NCT05070975|Other|Epidemiology|Assessment of the discrepancy of clinical severity of RSV-infections between twin infants.
15724292|NCT05070962|Other|clinical population|or the general population, students of the University of Lille will be offered the opportunity to participate in a study through posters in the corridors of the faculties and announcements in the lecture halls.
15724294|NCT05070936|Other|vestibular rehabilitation|Vestibular rehabilitation consisted of a total of 4 sessions, rearranged every 15 days. These exercises were prepared gradually to increase the vestibulo-ocular reflex and vestibulospinal reflex. The following exercises were done with the patients: both sitting and standing gaze stabilization exercises, neck joint range of motion exercises, 20 minutes walks outside, walking backward both open-and-closed eyes, and walking in tandem with both open-and-closed eyes. The therapist gave the patients a home exercise program. It was emphasized that the exercises should be applied as 10 repetitions. After the session, the exercises shown to the patients were explained in written form and given as home exercises. They were also asked to do home exercises 3 times a day, 10 repetitions, for 15 days. Evaluation of the patients was done at the beginning of the first session and the 4th session. Thus, 3 separate exercise sessions and a home exercise program were applied to the patients.
15724295|NCT05070923|Behavioral|HealthyLifetime|HL augments existing case management services by focusing on building the participant's personal capacity for independence in self - care skills, health behavior change, and health decision making. The HL program coordinates and interfaces with the enrollee's primary medical provider, case managers, and caregivers as necessary
15724296|NCT05070910|Behavioral|Therapy|The intervention performed in the practicum will not be able to be influenced by the study investigators and the intervention may be different for each child based on their needs
15724297|NCT05070897|Other|Questionnaires|"Approved French version of the FCCHL scale
~Questionnaire on the use of digital tools adapted from the questionnaire on digital tools"
15724298|NCT05070884|Other|The development of new clinical AI solutions to predict treatment response to neoadjuvant chemotherapy (NAC) in breast cancer|Evaluate response to neoadjuvant treatment in advanced breast cancer
15724299|NCT05070871|Dietary Supplement|Hydrolyzed Collagen|Hydrolyzed collagen type II derived from the bone powder of Norwegian Atlantic salmon.
15724300|NCT05070871|Other|Placebo|Pure maltodextrin.
15724301|NCT05070871|Dietary Supplement|CalGo|CalGo is a natural marine collagenic bone powder from salmon. The bone powder is a 100 % microcrystalline hydroxyapatite form of calcium and collagen type 2.
15724302|NCT05070858|Drug|Pozelimab (REGN3918) + Cemdisiran|Subcutaneous administration as described in the protocol
15724303|NCT05070858|Drug|Cemdisiran|SC administration as described in the protocol
15724304|NCT05070858|Other|Placebo|SC administration as described in the protocol
15724305|NCT05070845|Biological|PF-06835375|CXCR5 inhibitor
15724306|NCT05070832|Procedure|Deep Hyperthermia|Hyperthermia is a type of treatment in which tumor is heated to as high as 40.5-43℃ to help damage and kill cancer cells with little or no harm to normal tissue.
15724307|NCT05070819|Diagnostic Test|pro-ANP|pro-ANP samples and fluid status assessment with functional tests (Teboul test) will be used 8 times intraoperatively.
15724308|NCT05070793|Behavioral|Culturally adapted interpersonal psychotherapy|Individual psychotherapy based on Brief Interpersonal Psychotherapy, culturally adapted for transgender and nonbinary individuals.
15724312|NCT05070754|Device|Floating electrode-dielectric barrier device (FE-DBD) cold atmospheric plasma (CAP)|The treatment device in this study generates cold atmospheric plasma. Cold atmospheric plasma has certain properties of plasma, such as ionized gas molecules. To create plasma, a pulse generator supplying 20 kilovolt pulse of 20-ns pulse width at 200 Hz (FPG10-01NM10, FID GmbH, Burbach, Germany) to a 5-mm diameter quartz-covered copper electrode of 10-cm length and 1 - 13mm quartz thickness. These nanosecond pulse parameters were chosen to provide sufficient treatment dose at the high level of plasma uniformity required to avoid any tissue damage. We will treat the lesions for approximately 1 to 2 minutes each, moving the electrode gently over the treatment area.
15724313|NCT05070754|Device|Cryotherapy|Cryotherapy refers to the application of liquid nitrogen using a cryospray device in order to freeze a lesion of interest. Treatment is repeated every few weeks until the lesion of interest has disappeared. It is considered SOC for the treatment of warts.
15724314|NCT05070754|Drug|Canthardin Collodion|Chemical compound that acts as a vesicant to form a blister around treatment area. The blister lifts the lesion of interest away from the skin, causing it to slough off in a few days. It is used as SOC for the treatment of Molluscum Contagiosum.
15724315|NCT05070741|Behavioral|Heat Therapy|Subjects will undergo 12 hot water immersions of 40.5 degrees Celsius for approximately 45 minutes per session over 4 weeks. Subjects will be immersed up to the shoulder in a 40°C hot tub until rectal temperature (Tre) increases by 1°C (~20 minutes). Subjects will then remain in the water bath submerged to waist level to maintain Tre between 38.5 and 39.0°C for another 30 minutes (approx. total time submerged ~50 minutes). Following hot water immersion, subjects will be monitored for another 10 min, or until Tre falls below 38.5°C. Core temperature will be monitored using either 1) a rectal probe with sterile disposable sheaths or 2) a sterile disposable rectal thermistor probe (401 A/C, Advanced Industrial Systems, Inc., Harrods Creek, KY) to be inserted ~1 inch past the anal sphincter (inserted by participant). Heart rate and blood pressure will be monitored throughout the treatment. Subjects will be continually monitored and removed from the hot bath if Tre exceeds 39.5°C.
15724316|NCT05070728|Drug|Sham Injector|Sham injection
15724317|NCT05070728|Drug|FAI Insert|FAI insert
15724318|NCT05070715|Other|Analyzing of microplastic level|Blood samples will be taken from the vein of the umbilical cord. Placental tissues will be taken from the maternal side of the placenta. Placental tissues and serum samples will be stored in the temperature set to -80 °C until analysis. Extraction methods involving chemical reactions will be used to separate and purify microplastics in placenta and cord blood samples. After the extraction process, analysis of microplastic levels in tissues and serum will be done by µ-Raman spectroscopy.
15724319|NCT05070702|Drug|CT-1500|Hard Capsule
15724320|NCT05070702|Drug|Placebo|Hard Capsule
15724321|NCT05070689|Procedure|ACCSS|A. Chohan Continuous Squeezing Suture (ACCSS)
15724322|NCT05070676|Diagnostic Test|newly developed mobile application|"The application will be developed in native Android, using Java (backend) and XML (front-end) as the programming language. The program of choice will be Android Studio®, YouTube® (video reproduction) and Firebase® (database) will be used as external APIs (Application Programming Interfaces).
~The layout of the application will be developed using:
~Adobe Illustrator® software. The logo, brand, objects, and shapes of the mobile application will be designed to enable to resize of the images without any loss of quality, due to the wide range of scales available in current smartphones"
15724323|NCT05070650|Drug|Acetylcysteine|200 mg/500 mg/10 mg granules for oral solution: one sachet three times per day
15724324|NCT05070650|Drug|Paracetamol|500 mg/10 mg granules for oral solution: one sachet three times per day
15724325|NCT05070650|Drug|Phenylephrine|500 mg/10 mg granules for oral solution
15724326|NCT05070637|Procedure|No-touch laparoscopic radical nephrectomy|We aim to determine if a laparoscopic no-touch nephrectomy with an early renal pedicle ligation can decrease CTC release during surgery.
15724327|NCT05070637|Procedure|Conventional laparoscopic radical nephrectomy|Conventional laparoscopic radical nephrectomy, which implies manipulation of the kidney, opening of the Gerota's fascia, and manipulation of peri-nephric fat during dissection, and renal pedicle isolation.
15724328|NCT05070637|Procedure|Laparoscopic total nephrectomy control arm|Control arm in which a laparoscopic total nephrectomy will be performed in non-cancer patients.
15724329|NCT05070624|Behavioral|The Virtual Peer Support Program|Training: We have previously developed and beta-tested a virtual peer mentor training program adapted from the St. Jude's Research Hospital's (Memphis, USA) program for FCs of children with cancer for adults using HMV. Content & Design of the Virtual Peer-Support Program: The program will be delivered by the aTouchAway™ App used for the LIVE program. Participants will be requested to access peer mentors ≥1 time/week. Participants can choose to interact with a peer mentor which will be assigned as well as other peer participants. Onboarding: Participants and mentors will create a personal profile of their caregiving situation (e.g., duration of care, family member age and diagnosis), to enable selection of mentors by the research team believed to be well suited to address support needs, questions, and concerns based on similar lived experience.
15724330|NCT05070611|Device|IPL-MGX|One week after lesion incision, the E-Eye machine (E-SWIN company, France) IPL treatment was administered to the skin area below the lower eyelid.13 Before treatment, the eyes were protected with opaque goggles and ultrasound gel was applied on the patient's face from tragus to tragus including the nose to conduct the light.
15724331|NCT05070598|Drug|Camrelizumab +Pyrotinib + Nab-paclitaxel + Tegafur|Camrelizumab was given in the first day of each cycle,Nab-paclitaxel was given in the first day of each cycle, Pyrotinib was given everyday of each cycle, Tegafur given in the day 1-14 of each cycle
15724333|NCT05070572|Device|Accuryn Monitoring System|Utilization of the Accuryn Monitoring System to measure intraabdominal pressure and urine output during laparoscopic inguinal hernia repair surgery.
15724334|NCT05070559|Other|Active Release Technique|"Patients in this group will receive Active Release Technique along with conventional therapy. ART will be given with patient seated, elbow flexed and resting on the treatment table, forearm in midprone & wrist in neutral position and then the therapist will work on the common extensor tendon by applying pressure to the tendon distal to their attachment at the elbow. The patient will start with the elbow bent and wrist straight. As the therapist hold the muscles, the patient will extend the elbow and pronate and flex the wrist while the therapist move the pressure proximally, attempting to release adhesions around and between muscle planes. Total of 15 repetitions for of 10 minutes.
~CONVENTIONAL THERAPY:
~Hot pack for 15 minutes
~TENS for 15 minutes
~Ultrasound (pulsed mode, 1MHz at 1.5 W/cm2 for 5 minutes)"
15724335|NCT05070559|Other|Graston Technique Group|"Patients in this group will receive IASTM along with conventional therapy. In graston technique proper application of GT3 which include application of a cream to the common extensor tendon. The GT3will be then used to common extensor tendon. In areas of increased tissue restriction, more required pressure with GT3 is applied using increased force and shorter strokes over the areas of restriction. Ice will be offered as needed for pain management after each session.
~The study includes interventional protocol of 4 weeks. The sessions will be given 3 times a week for 4 weeks.
~CONVENTIONAL THERAPY:
~Hot pack for 15 minutes
~TENS for 15 minutes
~Ultrasound (pulsed mode, 1MHz at 1.5 W/cm2 for 5 minutes)"
15724338|NCT05070533|Behavioral|Individual treatment|Participants will receive 7 home visits to implement the program.
15724339|NCT05070533|Behavioral|Groupal treatment|Subjects will participate in groups of about 8 - 12 to implement the program.
15724340|NCT05070520|Drug|Artemether-lumefantrine|Efficacy of artemether lumefantrine for the treatment of uncomplicated Plasmodium falciparum malaria in three sentinel sites in Niger (Agadez, Gaya and Tessaoua) in 2020
15724341|NCT05070507|Dietary Supplement|Enzyme containing lozenge|Subjects are instructed to take one lozenge three times daily, at least 30 minutes after a meal, for seven days. No oral health care procedures are allowed during the intervention period.
15724342|NCT05070507|Dietary Supplement|Placebo lozenge|Subjects are instructed to take one lozenge three times daily, at least 30 minutes after a meal, for seven days. No oral health care procedures are allowed during the intervention period.
15724343|NCT05070494|Biological|Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated)|study of immunologic response to different dose and duration of Egg-derived standard dose trivalent influenza vaccine (surface antigen, inactivated)
15724344|NCT05070468|Drug|Dexamethasone 0.5mg|Pregnant women with a gestational age of 38 weeks and older admitted to Labor Of Kamali Hospital, for termination of pregnancy, by accident and based on the coding done by a statistician to identify groups of users of pill A or pill B, 14 pills are used vaginally . The client and the researcher are blinded and the pharmacist delivers the dexamethasone and placebo tablets with codes A and B to the researcher.
15724345|NCT05070468|Drug|Placebo|Pregnant women with a gestational age of 38 weeks and older admitted to Labor Of Kamali Hospital, for termination of pregnancy, by accident and based on the coding done by a statistician to identify groups of users of pill A or pill B, 14 pills are used vaginally . The client and the researcher are blinded and the pharmacist delivers the dexamethasone and placebo tablets with codes A and B to the researcher.
15724346|NCT05070455|Biological|Asceniv™|Each subject will receive an intravenous infusion of Asceniv™ on Study Day 1 (required to be within 28 days of screening) and every 21 or 28 days thereafter according to their current interval of IGIV treatment. Subjects will receive Asceniv™ at the same dose or higher dose if medically appropriate (300-800 mg/kg), every 21 or 28 days for five months (seven or six doses respectively).
15724347|NCT05070442|Behavioral|Norm-based messaging and peer comparison features|"Participants are shown a version of NUSMart which includes Nutri-Score labels that are enabled and displayed besides all the products in the store. Additionally, they are shown a video that gives them background information about Nutri-Score labels and describes the following features enabled in this intervention:
~Norm-based messaging will be displayed in the form of a happy or sad emoticon based on whether the participant's current basket average Nutri-Score (weighted by number of servings) is above or below other shoppers (Nutri-Score=3.98).
~Peer comparison will be implemented as a vertical ruler display of the participant's current basket average Nutri-Score (weighted by number of servings) as well as that of their peers.
~Nutri-Score=3.98 was chosen as it is 10% better than the mean Nutri-Score of baskets purchased by participants in the Nutri-Score labelled intervention arm of a prior study."
15724348|NCT05070442|Behavioral|Financial Incentives leveraging on loss aversion|"Participants are informed that they have received an additional $5 towards their participant reimbursement. However, this amount will be forfeited if they check-out with a basket average Nutri-Score (weighted by the number of servings) that falls below the average Nutri-Score of other shoppers i.e. 3.98. An indicator on the screen that informs the participants of this potential forfeiting will be included."
15724349|NCT05070429|Other|Clinic-based audiological rehabilitative service delivery|Participants will have scheduled clinic-based visits at 6 and 12 months post-randomization to reinforce self-management strategies and perform hearing aid checks.
15724350|NCT05070429|Other|Telehealth audiological rehabilitative service delivery|Participants' scheduled clinic-based visits will be complemented with asynchronous and synchronous telehealth that will allow for routine troubleshooting of communication challenges, hearing aid technical issues, and reinforcement of self-management support strategies. At an initial session, participants will be instructed in the use of a study-provided, internet-enabled tablet device for telehealth sessions, re-introduced to the hearing loss toolkit for self-management and C2Hear Reusable Learning Objects within the context of the telehealth platform, re-evaluated on the Client Oriented Scale of Improvement (COSI) goals. Two remote follow-up sessions will be scheduled 3 and 6 weeks later to confirm participants' comfort with the telehealth platform and then completed every 6 months, in addition to scheduled 6-month clinic-based visits.
15724351|NCT05070416|Device|Lithium disilicate crowns|The study population is separated in two groups. The teeth will be etched in total etch mode with 37% phosphoric acid (Total Etch, Ivoclar Vivadent AG). After the application of Adhese Universal-adhesive (Ivoclar Vivadent AG), MultiCore Flow (Ivoclar Vivadent AG) will be applied. The crowns will be polished, then etched with IPS Ceramic Etching Gel (Ivoclar Vivadent AG) and conditioned with Monobond Plus (Ivoclar Vivadent AG). The crowns will be luted as described for group 1 or 2. A final intraoral polishing step will be done with OptraGloss (Ivoclar Vivadent AG). All required light-curing steps are conducted with Bluephase G4 (Ivoclar Vivadent AG).
15724352|NCT05070403|Drug|Afatinib 40 MG|Participants will receive 40 mg Afatinib, once daily.
15724353|NCT05070390|Drug|MK-0616|10 mg capsule administered orally
15724354|NCT05070377|Other|Physical activity|"structured physical activity sessions by physical education (school), twice a week, with twenty-minute each lesson;
~self-monitoring plus goal setting by pedometer (out-of-school), progressive goals to achieve weekly;
~healthy lifestyle guidance ( parents social support)."
15724355|NCT05070364|Drug|Peginterferon Lambda-1a|Immunomodulator
15724356|NCT05070351|Drug|PPI deprescribing|Patients currently on a proton pump inhibitor (PPI) undergoing transjugular intrahepatic portosystemic shunt (TIPS) creation as part of routine clinical care will be randomized to receive instructions to stop taking their PPI.
15724357|NCT05070338|Behavioral|Guideline-Based (Injunctive Norm) Nudges|"Surgeons in this arm will receive an email with the following content at the end of each month in which at least two of their patients are discharged with an opioid prescription that exceeds the prescribing guideline for the procedure performed.
~Dear Dr. [Name],
~In [month], at least XX of your patients were discharged with opioid prescriptions exceeding the amounts recommended by safety guidelines for these procedures.
~For patient safety, Sutter Health recommends prescribing within the ranges below for these procedures. Doing so will also meet best-practice safety guidelines for post-operative opioid prescribing.
~We will continue to send you opioid prescribing safety reports.
~Sincerely, [Signature]
~[Table displaying recommended ranges of 5mg oxycodone tablets for each procedure]"
15724358|NCT05070338|Behavioral|Peer-Based (Social Norm) Nudges|"Surgeons in this arm will receive an email with the following content at the end of each month in which at least two of their patients are discharged with an opioid prescription that exceeds the prescribing guideline for the procedure performed.
~Dear Dr. [Name],
~In [month], at least XX of your patients were discharged with opioid prescriptions exceeding the amount prescribed by YY% of your peers for these procedures.
~YY% of [specialty] surgeons at Sutter Health prescribe within the ranges below for these procedures.
~We will continue to send you opioid prescribing safety reports.
~Sincerely, [Signature]
~[Table displaying recommended ranges of 5mg oxycodone tablets for each procedure]
~The ranges of 5mg oxycodone tablets displayed will be the same as the ranges stipulated by the prescribing guidelines, but this nudge will not mention guidelines."
15724359|NCT05070325|Other|Cold application group|Cold application group (Group 1): In the children in this group, the injection site was cleaned before the injection using antiseptic cotton and then the gel pad was placed on the injection site. In line with the literature, the cold gel pad was applied to the intramuscular injection site for 30-45 seconds before the injection and then the injection was delivered. The children were told to breathe deeply and not to tense up during the injection.
15724360|NCT05070325|Other|Shotblocker group|Shotblocker group (Group 2): The injection site was cleaned using antiseptic cotton. The surface of the Shotblocker with the contact points was placed on the site just before the injection in a way not to contaminate the injection point. Injection was carried out through the opening in the middle of ShotBlocker. The children were told to breathe deeply and not to tense up during the injection. After the injection was completed, ShotBlocker was removed from the skin.
15724361|NCT05070325|Other|Control Group|Control Group (Group 3): The routine IM injection was applied to the children in this group. The injection site was cleaned using antiseptic cotton. The children were told to breathe deeply and not to tense up during the injection.
15724362|NCT05070312|Biological|MEDI3506|MEDI3506
15724363|NCT05070312|Drug|Placebo|Placebo
15724368|NCT05070260|Drug|Intravenous glenzocimab (ACT017) 1000 mg|Add-on therapy to the standard of Care in the treatment of the acute ischemic stroke symptoms
15724369|NCT05070260|Drug|Intravenous Placebo|Add-on therapy to the standard of Care in the treatment of the acute ischemic stroke symptoms
15724370|NCT05070247|Drug|TAK-500|TAK-500 intravenous infusion.
15724371|NCT05070247|Drug|Pembrolizumab|Pembrolizumab intravenous infusion.
15724372|NCT05070234|Genetic|Blood collection for genetic analysis|Genetic tests in this study are sequential testing, including MS-MLPA, whole exome sequencing, whole genome sequencing, as well as RNA-seq.
15724373|NCT05070221|Drug|Recombinant Oncolytic HSV-2 Therapeutic Injecta (Vero Cell) for Human Use (rHSV2hGM-CSF)|less than 8mL/time，Q2W，i.t.；
15724374|NCT05070221|Drug|Recombinant humanized anti-PD-1 monoclonal antibody for injection|200mg/time，Q3W，i.v.；
15724375|NCT05070221|Drug|Axitinib|5mg，bid，p.o.；
15724376|NCT05070208|Other|NOT PROVIDED|NOT PROVIDED
15724377|NCT05070195|Drug|SKLB1028|SKLB1028, capsule, oral
15724378|NCT05070195|Drug|Midazolam|Midazolam Maleate, tablet, oral
15724379|NCT05070182|Diagnostic Test|REE - Resting Energy Expenditure|"REEs represent 60-70% of the needs for a sedentary person and 50% of physically active people.
~For the measurement of REE will be used the metabolic computer (Medical Graphics, Ultima CCM, Minneapolis, USA), which with continuous recording of breath-to-breath volume (Vt), respiratory rate (RR) of ventilation per minute volume (MV) ), of inhaled and exhaled gases (O2 and CO2) has the ability to calculate the values of VO2, VCO2 and with the help of equations the values of REE and RQ.
~All patients in the study will be monitored with the metabolic computer. Their measurements will be recorded every day during their stay in the ICU."
15724380|NCT05070182|Diagnostic Test|Transcranial Doppler|"The measurement of flow velocities in the middle cerebral artery will be done with the transcranial Doppler using a low frequency (2 MHz) ultrasound head.
~All patients entering the study will be examined with the TCD every day during their stay in the ICU."
15724381|NCT05070169|Procedure|Early Surgical Fixation vs. Delayed Surgical Fixation|Evaluation of the reduction of the peri-operative blood loss in patients undergoing early surgical fixation (within 24 hours) of an intertrochanteric fracture under DOAC therapy compared to a retrospectively enrolled group of patients who underwent delayed surgical fixation (≥48 hours) of an intertrochanteric fracture under DOAC therapy.
15724382|NCT05070156|Biological|Biological/Vaccine: Low-dose group|1.0×105/kg positive CAR-T cells injection. 2-n doses will be evaluated by the investigator if participant is qualify for certain condition.
15724383|NCT05070156|Biological|Biological/Vaccine: Mid-dose group|2.0×105/kg positive CAR-T cells injection. 2-n doses will be evaluated by the investigator if participant is qualify for certain condition.
15724384|NCT05070156|Biological|Biological/Vaccine: High-dose group|3.0×105/kg positive CAR-T cells injection. 2-n doses will be evaluated by the investigator if participant is qualify for certain condition.
15724385|NCT05070143|Behavioral|RISE-UP Routine|The participants in this condition will be instructed to substitute their current sleep habits with the RISE-UP routine that has been developed by our team (Kaplan, Talavera, & Harvey, 2018). This involves instructing participants to devise an individually tailored routine that will help them get up each morning (e.g., open blinds, make the bed, head for the shower).
15724386|NCT05070143|Behavioral|Awareness Training|The participants in this condition will be instructed in dismantling/disrupting the association between the cue and the habit via awareness training from habit reversal approaches (Azrin & Nunn, 1973; Ladouceur, 1979). This condition involves instructing the participant to develop an awareness of their decisions to stay in bed and snooze.
15724387|NCT05070143|Behavioral|Vigilant Monitoring|"The participants in this condition will be instructed in vigilant monitoring which involves internal repetition of get up! and don't do it and watching carefully for slipups (Quinn, Pascoe, Wood, & Neal, 2010)."
15724388|NCT05070143|Behavioral|Implementation Intentions|"The participants in this condition will be instructed in counter habitual implementation intentions. This involves instructing the participant to engage in implementation intentions in which they imagine replacing snoozing with getting up out of bed (Adriaanse, Gollwitzer, De Ridder, De Wit, & Kroese, 2011). The structure of this implementation intention is: If I wake up in the morning and I want a sleep-in then I will get up and start my day."
15724389|NCT05070143|Behavioral|Values-based Approach|The participants in this condition will be instructed in a values-based approach (Anshel, Brinthaupt, & Kang, 2010; Anshel & Kang, 2007). This involves asking the participants to reflect on how getting up consistently at the same time each day does or does not align with their values. They are asked to compare the costs and long-term consequences of continuing to engage in the unwanted habit and clearly articulating the disconnect between the habit and their values.
15724390|NCT05070143|Behavioral|Brief Education|"In this condition, participants only receive the learning module. This condition is included as a minimal intervention comparison condition that controls for the passage of time.
~First, education about the importance of regular wake times and sleep inertia that is a normal transitional stage between sleep and wake. The education will be delivered in this video format: https://www.youtube.com/watch?v=P6zcSFA7ymo. Second, after viewing the video, the key points will be summarized. Lastly, participants will be asked to summarize the four key takeaways for good sleep habits."
15724391|NCT05070130|Device|dPR and FFR|OpSens non-hyperemic dPR and/or OpSens FFR
15724393|NCT05070104|Drug|CPI-613|250-1000mg/m2 -14 day cycle
15724394|NCT05070104|Drug|modified FFX|Irinotecan: 150mg/m2 IV over 90 min-14 day cycle Leucovorin: 400mg/m2 IV over 2hrs with Irinotecan-14 day cycle Oxaliplatin: 85mg/m2 IV over 2hrs-14 day cycle 5FU: 2400mg/m2 IV over 46-48 hrs-14 day cycle
15724397|NCT05070052|Behavioral|cognitive behavioral therapy|9 sessions of CBT weekly treatment in group setting
15724398|NCT05070052|Behavioral|mindfulness-based cognitive therapy|9 sessions of MBCT weekly treatment in group setting
15724399|NCT05070039|Genetic|Expression of Cortactin anti body|assessment of Cortactin immunohistochemical expression in invasive and non-invasive urothelial carcinoma.
15724400|NCT05070026|Other|uni-portal VATS group|patients received pulmonary lobectomy under general anesthesia by using uni-portal VATS method
15724401|NCT05070026|Other|three port VATS group|patients received pulmonary lobectomy under under general anesthesia by using three port VATS method
15724402|NCT05070013|Device|Deep Brain Stimulation|All subjects will undergo three 1-week conditions of stimulation during nighttime sleep over the course of three consecutive weeks of in-home sleep: adaptive stimulation, open-loop stimulation and no stimulation.
15724403|NCT05070000|Diagnostic Test|Radiologic examination|Patients underwent US, CT or CT after US
15724404|NCT05069987|Other|Virtual Reality Immersion|An immersive virtual reality experience will be generated by a head mounted device which shows the user pre-recorded videos (SynVR Relax & Distract, SyncVR Medical BV, Utrecht, The Netherlands). These videos are recorded in 360 degree views and matched with the users' viewing direction by the head mounted device matches. The user will not be able to see its in vivo surroundings (i.e. the Cathlab) and will be focused on the digital content. The VR immersion will be put into place throughout the entire TAVR procedure starting before femoral access obtainment and ending after access closure.
15724407|NCT05069961|Procedure|ESPB|Ropivacaine is injected near the nerves in the back
15724408|NCT05069961|Procedure|TEA|Bupivacaine is injected into the space around the spinal cord.
15724409|NCT05069948|Other|HeadOn|HeadOn is a web application which takes the participant through a 5-stage CBT programme including: (i) understanding post-concussion symptoms; (ii) sleep after a concussion; (iii) lifestyle habits and exercise; (iv) managing negative thought patterns and (v) returning to baseline. The programme is delivered through a combination of weekly tasks (such as completing symptom diary, setting exercise goals and setting up a sleep time routine), audio/video media and reading material.
15724410|NCT05069935|Drug|FT538|FT538 is an allogeneic natural killer (NK)-cell immunotherapy
15724411|NCT05069935|Drug|Cyclophosphamide|Lympho-conditioning agent
15724412|NCT05069935|Drug|Fludarabine|Lympho-conditioning agent
15724413|NCT05069935|Combination Product|Monoclonal antibody - Dose Escalation|either avelumab, trastuzumab or cetuximab
15724414|NCT05069935|Combination Product|Monoclonal antibody - Dose Expansion|either avelumab, atezolizumab, nivolumab, pembrolizumab, trastuzumab or cetuximab
15724415|NCT05069922|Other|Fresh Frozen Plasma|Fresh Frozen Plasma
15724416|NCT05069909|Procedure|Denture Fabrication technique|Each patient received two sets of dentures fabricated using the two different techniques and their satisfaction and OHIP-EDENT were compared
15724419|NCT05069883|Drug|Steroid Drug|In this group Oral steroid medication after Direct Vision Internal Urethrotomy
15724420|NCT05069883|Drug|No steroid|In this group no Oral steroid medication (palcebo medication) after Direct Vision Internal Urethrotomy
15724421|NCT05069870|Drug|SKLB1028|SKLB1028, capsule, oral
15724422|NCT05069870|Drug|Itraconazole|Itraconazole, capsule, oral
15724423|NCT05069870|Drug|Gemfibrozil|Gemfibrozil, capsule, oral
15724424|NCT05069870|Drug|Rifampicin|Rifampicin, capsule, oral
15724425|NCT05069857|Drug|Camrelizumab (anti-PD-1 inhibitor)|The patients will receive three cycles of Camrelizumab, with 14 days each. 200mg of Carrelizumab will be used intravenously on the first day of each cycle.
15724426|NCT05069857|Drug|Apatinib (anti-VEGFR inhibitor)|The patients will receive Apatinib orally 250mg once a day from the first day of each cycle until the 9th day of the third cycle.
15724429|NCT05069831|Drug|Abrocitinib|Abrocitinib daily for 4 months
15724430|NCT05069805|Procedure|PECS II block|Pacients will receive standard general anesthesia with sevoflurane and fentanil associated to PECS II block
15724431|NCT05069805|Procedure|ESP block|Pacients will receive standard general anesthesia with sevoflurane and fentanil associated to ESP block
15724432|NCT05069779|Drug|Diazepam|Oral administration of 10 mg of diazepam
15724433|NCT05069766|Other|BioXmark™|During a scheduled outpatient gastroscopy, the tumor margins will be endoscopically marked by BioXmark™. BioXmark™ will be implanted at the most proximal margin of the tumor and 5 cm proximally of the tumor border.
15724436|NCT05069740|Drug|Salsalate Pill|Salsalate acts as an NFkB inhibitor to reduce systemic inflammation
15724437|NCT05069740|Drug|Placebo|Placebo for the salsalate intervention
15724438|NCT05069727|Procedure|Regular Protocol with advanced carbohydrate counting|"Review 3 Days CGM data in Manual Mode
~Carb Ratio by formula 360 / TDD
~Finetune ICR
~Target 100 or 110 mg/dl
~AIT: 2-3 hour
~Insulin Bolus for meal (advanced carb counting)
~The parameters will be set using clinical assessment and fine-tuned if needed on F-up visits.
~Follow up visits will be scheduled Day 7, 14,28, 56 and 84 after enabling SmartGuard (AHCL use)."
15724439|NCT05069727|Procedure|Simplified Protocol with fixed carbohydrate content|"Review 3 Days CGM data in Manual Mode
~Carb Ratio by formula 360 / TDD ICR 8-10 (TDD 40-60) ICR 5-7 (TDD >60)
~Target 100 mg/dl
~AIT: 2 hours
~Insulin Bolus for meal (Thee sets of meal set of meals announcement carbs will be provided) Regular meal: Total Carbs per Day x 0.6 / 3 Large meal: Total Carbs per Day x 0.6 / 3 x 1.5 Small (Snack) meal: Total Carbs per Day x 0.6 / 3 x 1.5
~Total carbs per day will be calculated as average on 7-days Food Logbook diary, provided by participant, one week before AHCL initiation.
~The parameters will be fixed and fine-tuned only in case of hypoglycemia on F-up visits."
15724440|NCT05069714|Drug|Methotrexate|Temporary discontinuation of methotrexate for 1 week vs. 2 weeks
15724442|NCT05069688|Drug|rifampicin|Patients will receive standard TB and HIV treatment, however, for two weeks (study weeks 20-21) the dose of rifampicin will be increased from standard-dose to high-dose to assess pharmacokinetics and safety
15724443|NCT05069675|Procedure|vitrectomy|vitrectomy with gas tamponade
15724444|NCT05069662|Other|Directive Interview|One directive interview conducted by telephone
15724445|NCT05069649|Drug|Ergoferon|Tablet for oral use.
15724446|NCT05069649|Drug|Placebo|Tablet for oral use.
15724447|NCT05069636|Other|Lymphatic OMM|Patients receive lymphatic myofascial release and thoracic pump techniques.
15724448|NCT05069636|Other|Light Touch|Patients receive a series of light touch techniques.
15724451|NCT05069610|Biological|AD17002|A recombinant protein
15724452|NCT05069610|Biological|Placebo (Formulation buffer)|Formulation buffer
15724454|NCT05069584|Procedure|Biopsy|patient must have a biopsy for his prostate cancer
15724455|NCT05069571|Other|Endoangel|Collecting the colonoscopy videos and analyzing the correlation between withdrawal overspeed proportion and adenoma detection rate.
15724456|NCT05069558|Device|Investigational PFO Closure Device|Occlutech Flex II PFO Closure Device
15724457|NCT05069558|Device|Standard of Care PFO Closure Device|Amplatzer PFO Occluder and Gore Cardioform PFO Occluder
15724458|NCT05069545|Drug|Insulin degludec|Introducing a NovoPen® 6 to patients with type 1 diabetes mellitus (T1DM), who are already being treated with Tresiba® and Fiasp®
15724459|NCT05069545|Drug|Fast-acting insulin aspart|Introducing a NovoPen® 6 to patients with type 1 diabetes mellitus (T1DM), who are already being treated with Tresiba® and Fiasp®
15724460|NCT05069532|Radiation|MSCT chest|CORAD 4-5 MSCT chest
15724461|NCT05069532|Diagnostic Test|PCR|PCR positive for COVID-19
15724462|NCT05069519|Behavioral|Personalized Smartwatch|"Participants will continue with standard care, but will receive a Fitbit and be encouraged to participate in at least 150 min. moderate-to-vigorous physical activity (5 sessions aerobic exercise, 30 min. per session; and 2 sessions of strength training) per week if their body condition allows throughout the intervention period. The previously established daily and weekly exercise prescription will be offered to participants based on their previous week Fitbit data.
~PA improvements will be tailored over time based on each participant's previous week PA and they will be encouraged to increase PA by 5-10 min/week if possible depending on specific situations. Participants will save each workout and synchronize the Fitbit PA data to its app where they only share daily data and receive weekly personalized exercise prescriptions established in pilot studies."
15724463|NCT05069519|Behavioral|Facebook Health Education|Participants assigned to this condition will receive a Fitbit smartwatch, continue with standard care, but will receive health education tips developed in the investigators' previous studies from a private Facebook group in which only group members and researchers can access. Additionally, the investigators will track login counts, analyze their post activity and online sentiments via texting mining and natural language processing, and then offer weekly personalized feedback based on the data to facilitate social support
15724464|NCT05069506|Other|Glucose as reference food|Twelve subjects (male: 4 female: 8) consumed 25g glucose diluted in 150ml water, two times, in different weeks, within 5-10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
15724465|NCT05069506|Other|Goat milk as test food|Twelve subjects (male: 4 female: 8) consumed 617 g goat milk yogurt, offering 25g available carbohydrate along with 250 mL water, one time, in different weeks, within 10-15 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
15724466|NCT05069506|Other|Goat milk and currants as test food|Twelve subjects (male: 4 female: 8) consumed 308 g goat milk yogurt and 19 g currants, offering 25g available carbohydrate along with 250 mL water, one time, in different weeks, within 10-15 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
15724467|NCT05069506|Other|Currants as test food|Twelve subjects (male: 4 female: 8) consumed 37.8 g currants, offering 25g available carbohydrate along with 250 mL water, one time, in different weeks, within 10-15 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
15724468|NCT05069506|Other|Sultanina raisins as test food|Twelve subjects (male: 4 female: 8) consumed 37.5 g sultanina raisins, offering 25g available carbohydrate along with 250 mL water, one time, in different weeks, within 10-15 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
15724469|NCT05069506|Other|Goat milk yogurt as preload|Forty-five healthy subjects (male: 12, female: 33) consumed a standardized breakfast (bread and honey) and 2h after were offered a preload given as snack (200g goat milk yogurt). Three hours after, subjects were given ad libitum access to a meal (lunch and dessert). The meal consisted of rice, roasted chicken breast and chocolate vanilla cake. Foods were weighed before serving and any leftovers were weighed again after meal. Fingertip capillary blood glucose samples were taken before breakfast, 120min after breakfast; before preload, 120minand 180minpost-preload consumption; before meal (lunch and dessert), 60minand 120min post-meal consumption. Subjective appetite ratings were assessed with 100mm VAS.
15724500|NCT05069220|Drug|18F-MFBG|Patients with neuroendocrine malignancies receive 148-444 MBq (4- 12mCi) of 18F-MFBG intravenously followed by PET/CT after 60-90min of injection.
15724470|NCT05069506|Other|Milk with lactic acid as preload|Forty-five healthy subjects (male: 12, female: 33) consumed a standardized breakfast (bread and honey) and 2h after were offered a preload given as snack (200g milk with lactic acid). Three hours after, subjects were given ad libitum access to a meal (lunch and dessert). The meal consisted of rice, roasted chicken breast and chocolate vanilla cake. Foods were weighed before serving and any leftovers were weighed again after meal. Fingertip capillary blood glucose samples were taken before breakfast, 120min after breakfast; before preload, 120minand 180minpost-preload consumption; before meal (lunch and dessert), 60minand 120min post-meal consumption. Subjective appetite ratings were assessed with 100mm VAS.
15724471|NCT05069493|Procedure|simple suturing|Hiatal hernia repair by simple suturing of the diaphragmatic
15724472|NCT05069493|Procedure|mesh|Hiatal hernia repair by tension-free mesh closure
15724473|NCT05069480|Device|Virtual reality-based training equipment.|It is a functional upper extremity rehabilitation device to provide specific therapy with augmented feedback. The equipment facilitates intensive task-oriented upper extremity therapy after stroke, traumatic brain injury, or other neurological diseases and injuries. It combines adjustable arm support, with augmented feedback and a large 3D workspace that allows functional therapy exercises in a virtual reality environment.
15724474|NCT05069480|Other|Traditional physical therapy program|The traditional physical therapy program aimed for inhibition of spasticity, facilitation of muscle action, and improving the motor functions of the involved upper limbs.
15724475|NCT05069467|Device|Acupuncture|For the active acupuncture group, the acupuncturist chose standard points depending on subjects' preferred positions. In addition, up to four acupuncture points were chosen on the basis of subjects' other presenting symptoms (such as fatigue, insomnia, or erectile dysfunction). The needles (30 or 40 mm and 0.25 mm gauge; Soochow, Hwato) will be inserted and manipulated until De Qi, a sensation of soreness and tingling.
15724476|NCT05069467|Device|Sham Acupuncture|Treatment will be the same for the sham acupuncture, except for the following: the acupuncturist selected the same number of nonacupuncture, nontrigger points. Instead of eliciting De Qi, the needles will be minimally manipulated to avoid eliciting sensations other than initial contact with skin.
15724477|NCT05069454|Biological|COVID-19 vaccine Observation of individuals who receive the COVID-19 vaccine|To measure the effectiveness of COVID-19 vaccines against symptomatic laboratory-confirmed SARS-CoV-2 infection amongst hospital level health workers eligible for vaccination.
15724478|NCT05069428|Drug|Ramelteon 8mg|administered crushed, orally at 20:30
15724479|NCT05069415|Device|Eyhance IOL|Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target emmetropia OU.
15724480|NCT05069415|Device|Eyhance IOL|Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. Target mini monovision in the non-dominant eye.
15724481|NCT05069402|Dietary Supplement|Immunonutrition|diet with immunonutrients
15724482|NCT05069402|Dietary Supplement|High-protein|Oral nutrition with high-protein content
15724483|NCT05069402|Dietary Supplement|Standard ONS|Oral nutrition with standard ingredients
15724487|NCT05069363|Device|Whole-Body Photobiomodulation Therapy|"All participants entering the trial will receive a course of whole-body PBM therapy
~The NovoTHOR Whole-Body PBM therapy device consists of a hinged, clamshell design with light-emitting diodes (LEDs) arranged to emit near-infrared and visible red light therapy is delivered to the entire body at once.
~Participants will be expected to lie horizontal in the device with the lid as closed as they are comfortable with.
~18 sessions is the currently recommended and widely instituted and accepted practice with the NovoTHOR device.
~The LED equipment delivers red and near infrared light therapy to the participant
~Session 1 = 6 minutes
~Session 2 = 12 minutes
~Sessions 3-18 = 20 minutes
~Timescale: 3 treatments/week for 6 weeks
~The dosage of LED light (also known as 'fluence') will be equivalent to 25J/cm2. The device will supply a dual wavelength of red and near-infrared light with a 50:50 ratio; 660nm and 850nm respectively"
15724488|NCT05069350|Drug|bupivacaine 0.5% and oxubuprocaine|using each drug as surface anesthesia before intravitreal injections
15724489|NCT05069311|Drug|Multimodal analgesia|"Multimodal analgesia includes the combination of:
~morphine given by PCA (patient-controlled analgesia) at 1 mg/dose
~bupivacaine 0.25% and dexmedetomidine 0.5 mcg/mL (total volume of 10 mL) by epidural-catheter bolus given preoperatively
~bupicavaine 0.125% and dexmedetomidine 0.5 mcg/mL at a 5 mL/hour rate per epidural-catheter given intraoperatively
~bupivacaine 0.1% and dexmedetomidine 0.5 mcg/mL given by programmed intermittent epidural bolus (PIEB), set to be delivered every one-hour
~etericoxib 90 mg per oral give two-hours before surgery and then continued until three days post-surgery
~paracetamol 1 g (intravenously) given on the day of the surgery, continued at 10 mg/kg dose every 8 hours until three days post-surgery"
15724490|NCT05069311|Drug|Conventional intravenous analgesia|Standard analgesia includes fentanyl 2 mcg/kg (bolus) and morphine given by PCA (patient-controlled analgesia) at 1 mg/dose
15724491|NCT05069298|Dietary Supplement|Silibinin A|The compound will be administered following a 300 mg / 3 day schedule, before each main meal.
15724492|NCT05069285|Other|self-help book|information and advice given in the self-help book
15724493|NCT05069285|Other|sleep hygiene advice|information and advice given on the sheet of paper with sleep hygiene
15724494|NCT05069272|Other|Bakuchiol and Ethyl Linoleate|A synergistic combination of Bakuchiol and Ethyl Linoleate
15724495|NCT05069272|Other|Vehicle|No actives
15724497|NCT05069246|Other|Nigella Sativa oil|5ml Nigella Sativa oil mixed into 5ml water prior to use and rinsed in the mouth for 3 mins and spitted out, used twice a day; morning and evening.
15724498|NCT05069246|Drug|Chlorhexidine mouthwash|10ml of chlorohexidine mouthwash used for 3mins and spit out, used twice a day; morning and evening.
15724499|NCT05069233|Other|UGI+SB|Patients who underwent combined upper digestive tract and small intestine examination under MCE.
15724501|NCT05069207|Other|POWER breathe K5|Maximum inspiratory pressure (MIP) and volume (Volume (V)) parameters will be evaluated with the POWER breathe K5 to evaluate
15724502|NCT05069181|Other|Pilates mat exercises|"Pilates mat exercises: Each Pilates session will last for one hour and commence with a 10 minute warm up and finish with a 10 min cool down. The subjects will be taught the 5 key elements of Pilates (lateral costal breathing, centring which is a neutral position of the lumbar spine with activation of the core muscles, ribcage placement, shoulder blade placement and neutral position of the cervical spine with slight upper cervical flexion at the cranio-cervical junction).
~Pilates exercise program will consist of warm up exercises, main treatment program (10 level) and cooling down exercises."
15724503|NCT05069181|Other|cervical stabilization exercises|training of deep cervical flexor muscles with pressure biofeedback unit, 20 min/day, 3 days/week for 12 weeks.
15724504|NCT05069181|Other|conventional physiotherapy|10 min hot pack on cervical area range of motion exercises and isometric neck exercises as a home program 3 days/week for 12 weeks
15724505|NCT05069168|Diagnostic Test|Echocardiography before and after TAVR|"Evaluation of severity of aortic stenosis using :peak velocity ,peak and mean pressure gradient and aortic valve area by continuity equation.-Evaluation of left ventricular dimensions ,volumes and systolic function as assessed by ejection fraction (EF) by m-mode and biplane simpson's method at apical 4 and 2 chambers view Speckle tracking echocardiography(STE) Apical four-, three-, and two-chamber views were used to obtain longitudinal and circumferential strain before and follow-up after TAVR.
~cardiac CT :Routine full protocol before TAVR for evaluation and Detection and calculation of left ventricular fibrosis using extracellular volume.
~Coronary angiography:evaluate the presence of CAD and calculation of syntax score(SS)"
15724506|NCT05069155|Behavioral|Gamification|Each participant signs a pre-commitment contract agreeing to try their best to achieve their daily step goal. Each week over the 12 week intervention period, participants are endowed 70 points (10/day). Participants are informed they will lose 10 points for each day the step goal is not met. Points are replenished at the start of the week. At the end of the week, if the participant has 40 points or more, he/she will advance one level, or drop one level if they have less than 40 points. The levels include: blue (lowest), bronze, silver, gold, platinum (highest). Each participant begins in the middle (silver). Each participant will also select a spouse, family member, or friend that they see often to serve as a supportive sponsor that receives a weekly email participants progress including points, game level, and average step countThis supportive sponsor will help to enhance social incentives to motivate the individual towards his or her goal.
15724507|NCT05069142|Other|Rehabilitation|Pre- and post-operative exercise and education.
15724512|NCT05069103|Device|Intervention|"Similar to the original TWIST trial , patients will receive access to the online tool hosted on the ISLA platform until postoperative day 30 which is composed of two parts:
~A series of simple questions related to the detection of surgical wound infection (e.g. redness, swelling, fluid leakage, etc). These questions would be expected to be routinely asked during in-person assessment, and these questions have been previously developed and tested within the TWIST trial (the only change being the addition of questions specifically relating to the change in these symptoms).
~At least one image of their surgical wound(s)."
15724513|NCT05069090|Behavioral|Lockdown and other social distancing measures|During the study period, the Chilean Ministry of Health established a five-step process for social distancing measures. These ranged from full lockdown (step 1) to almost no restrictions (step 5). Even under full lockdown, citizens were able to obtain permits for essential activities. Citizens had a maximum of two permits per week and were obtained in a virtual station of the Chilean Police Force (Carabineros de Chile).
15724514|NCT05069077|Other|Music|In the music group, music that chosen by the participant will be played through a speaker by the nursing staff during outpatient hysteroscopy. Music will be played through a speaker instead of headphones in order to maintain good communication and interaction between the participant and the doctor.
15724515|NCT05069077|Other|No music|Participants in the non-music group will undergo outpatient hysteroscopy in the same setting and standard procedure without listening to any music.
15724516|NCT05069064|Other|music|In the music group, music that chosen by the participant will be played through a speaker by the nursing staff during outpatient hysteroscopy. Music will be played through a speaker instead of headphone in order to maintain a good communication and interaction between the participant and the doctor.
15724517|NCT05069064|Other|no music|Participants in the non-music group will undergo hysterosalpingography in the same setting and standard procedure without listening to any music.
15724518|NCT05069051|Drug|Belimumab 200 MG/ML [Benlysta]|Patients obtain belimumab treatment in combination with rituximab and venetoclax
15724519|NCT05069051|Drug|standard of care|Patients obtain the standard of care: combination rituximab and venetoclax
15724520|NCT05069038|Drug|Palbociclib 125mg|Palbociclib at a dose of 125 mg should be taken by mouth with food on 21 days on 7 days off schedule (meaning: on Days 1-21of each 28-day cycle). If a subject misses a day's dose entirely, she must be instructed not to make it up the next day but just take her regular dose at the next assigned time. If a subject vomits any time after taking a dose, she must be instructed not to retake the dose but resume subsequent dosing at the next assigned time. If a subject inadvertently takes an extra dose during a day, she must be instructed to not take the next day's dose.
15724521|NCT05069025|Other|music|In the music group, music chosen by the participant will be played through a speaker by the nursing staff during outpatient hysteroscopy. Music will be played through a speaker instead of headphones in order to maintain good communication and interaction between the participant and the doctor.
15724522|NCT05069025|Other|no-music|Participants in the non-music group will undergo outpatient hysteroscopy in the same setting and standard procedure without listening to any music.
15724523|NCT05069012|Drug|Morphine Sulfate|Morphine is administered to provide pain relief after cesarean delivery; this is an assessment of the dose-response as measured by the duration of pain relief
15724524|NCT05068999|Device|shear wave elastography|"Shear wave elastography (SWE) is an emerging technology that provides information about the inherent elasticity of tissues by producing an acoustic radiofrequency force impulse, sometimes called an acoustic wind, which generates transversely-oriented shear waves that propagate through the surrounding tissue and provide biomechanical information about tissue quality. Although SWE has the potential to revolutionize bone and joint imaging, its clinical application has been hindered by technical and artifactual challenges. Many of the stumbling blocks encountered during musculoskeletal SWE imaging are readily recognizable and can be overcome, but progressive advances in technology and a better understanding of image acquisition are required before SWE can reliably be used in musculoskeletal imaging."
15724525|NCT05068986|Behavioral|Asthma education|All the study participants were subjected to an educational asthma program for 3 months for providing parents and children with information and skills to manage their asthma ,which was presented from the the first session, through providing a written asthma action plan, information about avoiding triggers, training in the correct use of medicines, including inhaler technique, information and support to maximize adherence . All patients were followed up by a phone call every 2 weeks and follow up visit monthly to confirm compliance to the educational program
15724526|NCT05068973|Device|NOVATECH® LUCIOLA™ EB - (Fiducial Marker)|Bronchoscopic implantation in the lung of the NOVATECH® LUCIOLA™ EB fiducial marker
15724527|NCT05068960|Drug|Liposomal bupivacaine|Addition of liposomal bupivacaine to the interscalene block for extended pain control following total shoulder arthroplasty
15724528|NCT05068960|Drug|Bupivacaine|Interscalene block with bupivacaine for pain control following total shoulder arthroplasty
15724529|NCT05068947|Drug|GV101|GV101 administered once orally.
15724530|NCT05068947|Drug|Placebo|Matched placebo
15724533|NCT05068895|Other|liquid chromatography-mass spectrometry|Metabolomics is a rapidly evolving high-throughput technology that allows the measurement of the entire complement of metabolites generated by biochemical reactions under certain conditions in biological fluids or tissues. This technology has been used extensively to identify biomarkers in various cancers, nervous system diseases, cardiovascular diseases, pituitary diseases, and other diseases. The identification of biomarkers can be clinically useful for a more accurate diagnosis, prognosis, and treatment choice as well as disease monitoring. Among mass spectrometry (MS) methods, liquid chromatography-mass spectrometry (LC-MS) has been recognized as a robust metabolomics tool and has been widely applied in metabolite identification and quantification due to its high sensitivity, peak resolution, and repro- ducibility.
15724534|NCT05068882|Dietary Supplement|Immunonutrition|Oral immunonutrition containing arginine, omega-PUFAs and antioxidants
15724535|NCT05068882|Dietary Supplement|High-protein nutrition|Oral nutrition with high-protein content
15724536|NCT05068882|Dietary Supplement|Standard nutrition|Oral nutrition with standard ingredients
15724537|NCT05068869|Other|Dignio Digital Remote Care intervention group|"The intervention consists of Dignio Prevent (for healthcare professionals) and MyDignio (for patients). The system is CE marked and the system satisfies all regulatory requirements for privacy and information security. Various components can be added for an individualized follow-up of the patients.
~Elements of the digital outpatient service in Dignio include patient reported outcomes and other questionnaires, tasks, objective measures, reminders and information, in addition to a chat function for asynchronous contact with healthcare personnel and video consultations for real-time consultations."
15724538|NCT05068869|Other|Usual Care Control group|Participants in the control group will receive follow-up at the outpatient clinic as per their needs.
15724539|NCT05068856|Drug|HRS2543|"Dose-escalation part For the dose-escalation study, five dose cohorts (25 mg , 75 mg , 150 mg , 300 mg , and 450 mg ) of HRS2543 are initially set.
~Dose-expansion part After the completion of dose-escalation study, the dose-expansion study will be carried out at the recommended dose level by the SMC."
15724540|NCT05068843|Procedure|arthroscopic partial meniscectomy|In the surgery group, the orthopaedic surgeon performed an arthroscopic partial meniscectomy within 4 weeks after allocation. The surgeon removed the damaged part of the meniscus, until a stable and solid meniscus remained. All patients received written post-operative instructions. Eight weeks after surgery, patients received a consult in the outpatient orthopaedic clinic. In agreement with the Dutch Orthopaedic Association Guidelines, patients were referred to physical therapy when signs of abnormal recovery were present.
15724541|NCT05068843|Other|Physical therapy|The treatment protocol consisted of a physical therapist-led incremental exercise program over a period of eight weeks, containing 16 sessions of 30 minutes each.
15724542|NCT05068830|Drug|ExPlas|"ExPlas (plasma from fit donors) is a Investigational Medicinal Product. ExPlas is plasma drawn by plasmapheresis once a month for 4 months, from a total of 30 donors (aged 18-40, BMI ≤27 kg/m2 and VO2max >50 mL/kg/min) at the Blood Bank at St. Olavs Hospital. All unites will be virus inactivated by the Intercept method (Cerus corporation, US) in accordance with the procedures at Blood Bank at St. Olavs Hospital.
~The transfusion volume will be 200 mL at every time point.
~The main study consists of 6 rounds of examinations in addition to 12 plasma transfusions during the time span of one year (weekly transfusions in 3 four-week periods) and one round of examinations 2 years after baseline. A follow-up visit is also planned 5 years after baseline."
15724543|NCT05068830|Drug|Octaplasma|"Octaplasma is defined as a Investigational Medicinal Product. Octaplasma is human pooled plasma produced by Octapharma (Lachen, Switzerland). The transfusion volume will be 200 mL at every time point .
~The main study consists of 6 rounds of examinations in addition to 12 plasma transfusions during the time span of one year (weekly transfusions in 3 four-week periods) and one round of examinations 2 years after baseline. A follow-up visit is also planned 5 years after baseline."
15724544|NCT05068830|Drug|Saline|"Saline is provided by the hospital pharmacies in Central Norway. The infusion volume will be 200 mL at every time point.
~The main study consists of 6 rounds of examinations in addition to 12 saline infusions during the time span of one year (weekly transfusions in 3 four-week periods) and one round of examinations 2 years after baseline. A follow-up visit is also planned 5 years after baseline."
15724545|NCT05068817|Other|Pilates mat exercises|"Pilates mat exercises: Each Pilates session will last for one hour and commence with a 10 minute warm up and finish with a 10 min cool down. The subjects will be taught the 5 key elements of Pilates (lateral costal breathing, centring which is a neutral position of the lumbar spine with activation of the core muscles, ribcage placement, shoulder blade placement and neutral position of the cervical spine with slight upper cervical flexion at the cranio-cervical junction).
~Pilates exercise program will consist of warm up exercises, main treatment program (10 level) and cooling down exercises."
15724546|NCT05068817|Other|cervical stabilization exercises|training of deep cervical flexor muscles with pressure biofeedback unit, 20 min/day, 3 days/week for 12 weeks.
15724547|NCT05068817|Other|conventional physiotherapy|10 min hot pack on cervical area range of motion exercises and isometric neck exercises as a home program 3 days/week for 12 weeks
15724548|NCT05068804|Procedure|Cooling|The participants in the cooling trial put cold towels on their forehead and neck for 3 min in the shaded dugout during their offensive half innings when they were not scheduled to hit or on base. Each participant received the cooling intervention 3 to 4 times in each game. After each use, the towels were kept in a cooler that contained water mixed with ice and salt to keep the temperature at approximately 0℃.
15724549|NCT05068804|Other|control|The participants in the control trial sat in the shaded dugout without any cooling intervention.
15724552|NCT05068778|Behavioral|Artificial Intelligence Application|AI application through smart phone
15724553|NCT05068765|Other|Communication skills psychoeducation|Intervention explanations are explained in the groups section.
15724554|NCT05068765|Other|General psychoeducation|İntervention descriptions are explained in the intervention groups section.
15724555|NCT05068752|Drug|Vemurafenib|Vemurafenib 720 mg PO BID daily given with Sorafenib 400 mg PO AM and 200 mg PO PM
15724556|NCT05068752|Drug|Sorafenib|Sorafenib 400 mg PO AM and 200 mg PO PM Vemurafenib 720 mg PO BID daily
15724557|NCT05068739|Procedure|PA-EMR|Standard oval-shaped, braided wire polypectomy snare with 10 mm or 20 mm loop diameter will be used. With the duodenoscope in a semi-long position, the tip of the snare will be anchored just below the transverse fold of the ampulla and opened above-downwards fashion until the orifice will be seen. The orifice will be strictly preserved to avoid the risk of PEP and approximately the upper two-thirds of the ampullary mound will be grabbed by the snare. The direction and the depth will be controlled by combined movements of the elevator and wheels of the duodenoscope. After removal of the mucosa, the wall of choledochus will be seen clearly and standard wire-guided cannulation (WGC) will be performed. If cannulation can not be achieved with WGC, an additional incision will be performed to the wall of the choledochus with a needle knife.
15724558|NCT05068739|Procedure|NKF|The needle knife will be placed at the junction of the upper one-third and lower two-thirds of the papillary roof (bulging portion). Minimal, superficial incisions will be made in the 11-12 o'clock direction. The length of the fistulotomy will be at the endoscopist's discretion, depending on the shape of the papilla. The cut will be extended until bile juice, the pinkish bile duct mucosa, and/or the bulging of the white sphincter of the Oddi's muscle is visible.
15724560|NCT05068713|Other|Usual Care + High Target of Mean Arterial Pressure|Targeting the weaning of vasopressors to a mean arterial pressure of 85-90mmHg in the first 24h after liver trasnplant.
15724561|NCT05068713|Other|Usual Care|Targeting the weaning of vasopressors to a mean arterial pressure of 65-70mmHg in the first 24h after liver trasnplant.
15724562|NCT05068700|Device|Integrated Pulmonary Index|Medtronic Capnostream 35p monitoring parameter
15724563|NCT05068700|Device|Standard capnography monitoring|Medtronic Capnostream 35p monitoring parameter
15724564|NCT05068687|Diagnostic Test|high-resolution PET-CT specimen imaging.|"Included patients are given a single weight-dependent activity of 18F-FDG at the department of Nuclear Medicine. After administration, patients are brought to the operating room where standard of care surgical removal of the malignancy is performed.
~The resected specimen(s) are brought to the imaging lab and scanned using a preclinical PET/CT device. Following PET/CT imaging, the specimen is brought to the department of pathology, where it is sliced. Some of these slices are then rescanned using the preclinical PET/CT device. Moreover, frozen sections are made from one of these slices with macroscopically visible malignant tissue and placed on an autoradiograph overnight. Finally, the imaging results are then correlated to the results found during histopathological analysis of the specimens."
15724565|NCT05068674|Drug|Human Embryonic Stem Cell-Derived Cardiomyocyte 50M cells|50 million (M) cells delivered in a dose of 5M cells per injection over 10 injections.
15724566|NCT05068674|Drug|Human Embryonic Stem Cell-Derived Cardiomyocyte 150 cells|150M cells delivered in a dose of 15M cells per injection over 10 injections
15724567|NCT05068674|Drug|Human Embryonic Stem Cell-Derived Cardiomyocyte 300M cells|300M cells delivered in a dose of 30M per injection over 10 injections
15724568|NCT05068661|Drug|Ropivacaine 0.1% Injectable Solution|DPE
15724569|NCT05068661|Drug|Bupivacaine 0.25% Injectable Solution|CSE
15724570|NCT05068648|Other|Manual Wheelchair (MWC) backrest configuration|Wheelchair backrest fitting, postural and functional assessment
15724571|NCT05068609|Biological|Nivolumab|Participants in this study are being treated with nivolumab for SCCHN
15724572|NCT05068596|Other|expermintal|progressive resistive functional strength training in the plantigrade foot position plus designed physical therapy program
15724573|NCT05068596|Other|CONTROL|Designed physical therapy program
15724574|NCT05068583|Other|Blood Draw|Blood draw at baseline, disease evaluation time point, and pre and post surgery and/or radiation.
15724575|NCT05068570|Other|ARMEROMTERY|ARMERGOMTERY TRAINING FOR UPPERLIMB
15724576|NCT05068557|Dietary Supplement|Dietary plan along with fish oil capsules (3 capsules daily. Containing EPA+DHA: 1.8 g).|Subects within the Intervention group will be provided with a dietary plan along with fish oil capsules. Subjects will be asked to consume three capsules per day. Every capsule contains: EPA+DHA: 1.8 g.
15724577|NCT05068557|Dietary Supplement|Dietary plan along with chia/linseed oil capsules (3 capsules daily. Containing ALA 1.6 g).|Subects within the Intervention group will be provided with a dietary plan along with fish oil capsules. Subjects will be asked to consume three capsules per day. Every capsule contains: ALA 1.6 g).
15724578|NCT05068518|Other|No intervention|no intervention
15724579|NCT05068505|Behavioral|Community health worker delivered multicomponent intervention|The multi-component intervention will be centered on monthly household visits by trained CHWs for a period of one year in a rural setting in Nakaseke, Uganda, consisting of the following; (1) blood pressure and sugar monitoring; (2) BMI monitoring; (3) cardiovascular disease risk assessment; (4) Using checklists to guide monitoring and referral to clinics; (5) healthy lifestyle counselling and education. During home visits, CHWs will remind patients of follow-up visits. We will measure blood pressure at baseline and 3-monthly for the entire cohort. We will conduct individual-level mixed effects analyses of study data, adjusting for time and clustering by patient and community.
15724580|NCT05068492|Device|CT|enhanced CT with standard procedure
15724581|NCT05068492|Device|MRI|enhanced MRI with standard procedure
15724582|NCT05068492|Device|HVPG|HVPG measurements are performed by well-trained interventional radiologists in accordance with standard operating procedures
15724583|NCT05068479|Device|Bilateral Laser Scleral Microporation procedure|Partial depth scleral microporations with an Er:YAG laser in a predetermined pattern.
15724584|NCT05068466|Drug|INCB054707|Administered Orally
15724585|NCT05068466|Drug|Placebo|Administered Orally
15724586|NCT05068453|Drug|Recombinant Oncolytic HSV-2 Therapeutic Injecta (Vero Cell) for Human Use (rHSV2hGM-CSF)|OH2：less than 8mL/time，Q2W，i.t.；
15724587|NCT05068453|Drug|Recombinant humanized anti-PD-1 monoclonal antibody for injection|HX-008：200mg/time，Q3W，i.v.；
15724588|NCT05068453|Radiation|RT|3 times radiation，totally 24-30 Gy for each lession.
15724589|NCT05068440|Drug|Zanubrutinib|administered orally as capsules
15724590|NCT05068427|Drug|Chidamide|20mg or 30mg orally twice per week(BIW)
15724591|NCT05068427|Drug|Envafolimab|400mg subcutaneous infusions every 4 weeks
15724592|NCT05068414|Diagnostic Test|Blood panel|"Thrombin generation test
~Residual plasma concentration of dabigatran, rivaroxaban and/or apixaban (direct oral anticoagulants)
~International Normalized Ratio (if anti-vitamin K therapy is prescribed)
~Platelet aggregation test"
15724593|NCT05068401|Procedure|Bone Marrow Hematopoeitic Cell Transplant (HCT)|Bone Marrow stem cell graft is infused from a mismatched unrelated deceased donor on Day 0.
15724594|NCT05068401|Drug|Fludarabine|Given IV pre-transplant as part of conditioning regimen.
15724595|NCT05068401|Drug|Cyclophosphamide|Given IV pre-transplant as part of conditioning regimen.
15724596|NCT05068401|Radiation|Total Body Radiation (TBI)|Administered pre-transplant as part of conditioning regimen.
15724597|NCT05068401|Drug|Busulfan|Given IV or PO pre-transplant as part of conditioning regimen
15724598|NCT05068401|Drug|Mesna|Mesna is given in divided doses IV 30 min pre- and at 3, 6, and 8 hours post-cyclophosphamide.
15724599|NCT05068401|Drug|Post-Transplantation Cyclophosphamide|Cyclophosphamide (50 mg/kg) is administered on Day 3 and on Day 4 post-transplant.
15724600|NCT05068401|Drug|Sirolimus|Given at Day 5 with dose adjusted to maintain a level of 5-15 ng/mL through Day 180.
15724601|NCT05068401|Drug|Mycophenolate Mofetil|MMF is given at 15 mg/kg PO TID beginning on Day 5, maximum dose 1g PO TID (maximum daily dose 3g/day) through Day 35
15724602|NCT05068401|Drug|Growth Colony Stimulating Factor|G-CSF (filgrastim) or a biosimilar begins on Day 5 at a dose of 5 mcg/kg/day (according to actual body weight) IV or SC (rounding to the nearest vial dose is allowed), until the ANC is ≥ 1,000/mm3 over the course of 3 consecutive days.
15724603|NCT05068388|Drug|Z-Endoxifen|Z-Endoxifen
15724604|NCT05068388|Drug|Placebo|Placebo
15724605|NCT05068375|Diagnostic Test|Thrombophilia screening|Genetic thrombophilia and acquired thrombophilia screening
15724606|NCT05068362|Device|Auricular reconstruction|Medpor implant for treatment of microtia
15724607|NCT05068349|Drug|Butylphthalide|Butylphthalide sodium chloride injection 25mg, 2 times a day, 7-14 days, followed by 0.2g butylphthalide soft capsules, 3 times a day, 76-83 days, a total of 90 days.
15724608|NCT05068336|Diagnostic Test|desflurane anesthesia|Anesthesia maintenance of the first group will be provided with desflurane, one of the inhalation anesthetics we routinely use. Before and after the operation, blood will be taken from the patients, and the blood will be centrifuged to evaluate the heparan sulfate and syndecan levels.
15724609|NCT05068336|Diagnostic Test|sevoflurane anesthesia|Anesthesia maintenance of the first group will be provided with sevoflurane, one of the inhalation anesthetics we routinely use. Before and after the operation, blood will be taken from the patients, and the blood will be centrifuged to evaluate the heparan sulfate and syndecan levels.
15724610|NCT05068323|Diagnostic Test|Digital electroencephalography (EEG) for an hour (16 channels)|Digital electroencephalography (EEG) for an hour (16 channels)
15724611|NCT05068310|Device|Cellular resolution full-field optical coherence tomography|Device: ApolloVue® S100 Image System
15724612|NCT05068310|Device|Confocal microscopy|Device: Vivascope® will be used for skin imaging for a subset of skin lesions.
15724613|NCT05068310|Device|Optical coherence tomography imaging|Device: Vivosight® will be used for skin imaging for a subset of skin lesions.
15724614|NCT05068310|Device|Dermoscopy imaging|Device: Dermoscopy imaging will be conducted using but not limited to dermoscope DermLite FotoX®
15724617|NCT05068284|Drug|ABBV-154|Intravenous (IV) Infusion; Subcutaneous Injection
15724618|NCT05068284|Drug|Placebo|Intravenous (IV) infusion; Subcutaneous Injection
15724649|NCT05068076|Drug|Perfluorobutane|Perfluorobutane enhanced ultrasound will be done prior to ablation of HCC and after 2hours post ablation and comparison will be done with 1 month post procedure CT/MRI
15724650|NCT05068063|Drug|Bupivacaine Injection|Ultrasound-guided Femoral Triangle block with 20 mL of Bupivacaine 0.25% and IPACK block with 20 mL of Bupivacaine 0.25%
15727989|NCT05040295|Drug|ritlecitinib|30 mg spray congealed beads
15724619|NCT05068271|Behavioral|Multi-Domain Exercise Program|"The multi-domain exercise consisted of 15 min of warm-up and aerobic exercise from light to moderate intensity, 25 min of resistance exercise and flexibility exercise, 30 min of resistance exercise and coordinative exercise from the Eastern exercise perspective, 10 min of social interaction exercise, and 10 min of cool-down and meditation. Participants will be encouraged to attend the 90-min exercise program twice a week for 6 months, and to exercise at a moderate intensity for at least 20 min during each session."
15724620|NCT05068271|Behavioral|Active Control Group|"The usual physical activity group, as the active control group, will not receive an exercise program and will be informed to maintain their lifestyles. In addition, participants will be invited to attend the online educational course at a frequency of 2 sessions per week for 90 min each to eliminate the experimental expectation effect. The logs of physical activity behavior will be obtained from the participants once per month during the intervention period."
15724622|NCT05068245|Behavioral|Preselected classical music|Preselected classical music
15724623|NCT05068232|Radiation|Ablative Radiation|Ablative radiation therapy is a highly focused radiation treatment that gives an intense dose of radiation concentrated on a tumor or very specific area of the body, while limiting the radiation that affects surrounding organs.
15724624|NCT05068232|Drug|Durvalumab|Durvalumab is an immunotherapy drug -- a drug used to help boost your immune response to fight cancer.
15724625|NCT05068232|Drug|Etoposide|Etoposide is a chemotherapy drug approved for different kinds of cancer, including small cell lung cancer.
15724626|NCT05068232|Drug|Carboplatin|Carboplatin is a chemotherapy drug approved for different kinds of cancer, including small cell lung cancer.
15724627|NCT05068219|Procedure|Usual physical therapy|"Standard rehabilitation for diaphragmatic paresis
~EFA (Expiratory Flow Acceleration) at the upper thoracic level.
~PEP (Positive Expiratory Pressure).
~Expectoration if necessary (coughing up and spitting out)"
15724628|NCT05068219|Procedure|Contract-Relax technique|"The diaphragmatic CR is done in a semi-sitting position.
~The CR is composed of 4 steps :
~First maximum inspiration expiration with position of the hands of the physiotherapist on the last ribs and without resistance (Goal: taking rhythm).
~Second maximum inspiration expiration : Free inspiration, expiration with pressure on the last ribs to bring the diaphragm into internal stroke.
~Maximum inspiration against resistance, then maximum expiration with increased pressure.
~Maximum inspiration with dynamic release of resistance (Goal: hyperextension of the diaphragm) followed by maximum expiration with resistance to allow an increase in expiratory flow."
15724633|NCT05068193|Drug|BR2008-1 (R)|After fasting at least 10 hours, two tablets of BR2008-1 will be administered orally with 150mL of water around 8 a.m.
15724634|NCT05068193|Drug|BR2008 (T)|After fasting at least 10 hours, one tablet of BR2008 will be administered orally with 150mL of water around 8 a.m.
15724635|NCT05068180|Drug|low-dose neuroleptanalgesia|Droperidol 1.25 mg and fentanyl 0.025 mg (diluted with normal saline up to 5ml) is to be administrated intravenously 30 minutes before the end of the procedure.
15724636|NCT05068180|Drug|Placebo|The same volume of normal saline is to be administrated intravenously 30 minutes before the end of the procedure.
15724637|NCT05068167|Diagnostic Test|Kidney function test|Creatinine twice the baseline and urine output of fewer than 0.5 ml/kg per hour for 12 hours
15724638|NCT05068154|Diagnostic Test|Myovista® WavECG™|The MyoVista wavECG Device uses wavelet signal processing to extract frequency information from the acquired 12-lead ECG signal which is then analysed using artificial intelligence to provide information relating to left ventricular relaxation abnormalities
15724639|NCT05068141|Drug|SG001|Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection, 240 mg, i.v., q2w
15724640|NCT05068141|Drug|Nab-paclitaxel|Paclitaxel for Injection (Albumin Bound), 100 mg/m^2, i.v., D1, D8, D15 of every 4-week cycle
15724641|NCT05068128|Other|Flow MRI|"4 flow acquisitions based on the 2D cine phase contrast sequence (present on all MRI systems) will be performed.
~This sequence requires a cardiac synchronization by a plethysmograph put on the patient's finger.
~32 cardiac phases are reconstructed per acquisition. The processing of the flow MRIs and the analysis of the flow curves of the LCS and blood during the cardiac cycle will be performed using the Amiens software.
~Parameters measured via flow MRI are:
~- Cerebral vascular flow, intracranial LCS dynamic volume, extracranial LCS dynamic volume"
15724642|NCT05068128|Other|PERFUSION TEST|"The test will be performed will include:
~Inserting a needle into the lumbar space, Ommaya reservoir or valve pre-chamber, as appropriate
~Connect the needle to the pressure transducer via saline filled manometer lines connected via a 3-way valve. The other end of the 3-way connection will be connected to a saline
~Recording of the opening pressure for 10 minutes
~The infusion test is terminated either when the pressure stabilizes again on a new plateau, or when the average pressure exceeds 40 mmHg, or in case of adverse effects or symptoms such as headache, nausea/vomiting or visual disturbances.
~At the end of the test, a depletion of 30 to 50 mL of CSF will be performed.
~The pressure recording during the test is then used to calculate the parameters of the mechanical properties of the CSF circulation and reported to the neurosurgeon ordering the test."
15724643|NCT05068115|Procedure|Clinical characteristics, diagnosis and treatment, survival status|Describe the clinical characteristics, diagnosis and treatment, survival status and the trends of young breast cancer
15724651|NCT05068063|Drug|normal Saline|Ultrasound-guided Femoral Triangle block with 20 mL of Bupivacaine 0.25% and IPACK block with 20 mL of normal saline 0.9%
15724652|NCT05068050|Procedure|Horse-assisted therapy|"12 horse-assisted therapy sessions (45 mins each) for 6 weeks.
~Each session will comprise the next stages:
~Groundwork, Approachment and preparation of the horse, Warm up exercises
~Development of the main part (riding):
~Introduction - beginning: Breathing control and body awareness, maintain sitting (riding position) while walking on the horse, perceiving the movement Exercises for the postural and balance control: Variations in the walking of the horse, realize different figures in the arena (circles, serpentines, change direction…), Stopping and Walking, Arms situation combined with the movement of the horse All exercises are determined in the track design protocol Exercises for the acquisition of motion skills: Finished the riding with relaxation activities. Final part: Dismount the horse, Unsaddled and unbridle, feedback and goodbye procedure."
15724653|NCT05068050|Procedure|Physical exercise|"12 physical exercise sessions (45 mins each) for 6 weeks. Each session Each session Lessons will be held by physical activity professionals. The proposed exercises are focussed on improving the articular movements, aerobic resistance and the proprioception, always on the premises of No Pain.
~Lessons will be divided in three parts :
~1. Warmup - 2. Main part - 3. Return to calm
~Lessons will be hold online"
15724654|NCT05068037|Other|ACUPUNCTURE|standard acupuncture TCM (analgesia, vomiting)
15724655|NCT05068037|Other|ANTIEMETICS|NO ACUPUNCTURE, WITH ANTIEMETICS
15724656|NCT05068037|Other|NOTHING|NO ACUPUNCTURE, NO ANTIEMETICS
15724657|NCT05068024|Drug|FWD1509 MsOH|FWD1509 MsOH is administered orally once daily. The starting dose is 10 mg/day for dose-escalation phase, and the dose level to be investigated in the expansion study will depend on the emerging data. For dose-extension phase, the recommended Phase 2 dose will be administered.
15724658|NCT05068011|Device|Spinal Cord Stimulation|differential target multiplexed stimulation
15724659|NCT05067998|Dietary Supplement|IV Vitamin Infused Therapy Treatment|Vitamin B, C, D, E, K, liquid vitamins, antioxidants, amino acids, and minerals
15724660|NCT05067998|Drug|Herbal medicine|Herbal medicine is the use of plants to treat disease and enhance general health and wellbeing. Examples of common herbal health products and supplements include black cohosh, echinacea, garlic, ginkgo, saw palmetto, and St. John's wort just to name a few.
15724664|NCT05067959|Biological|Covid-19 vaccine|blood tests and questioners before 1st vaccine, 3 weeks before 2nd vaccine, 4 weeks after 2nd vaccine, 6 months after 1st vaccine, and 12 months after 2nd vaccine
15724665|NCT05067946|Biological|GX-19N|DNA vaccine expressing SARS-CoV-2 S-protein antigen including the Nucleocapsid protein (NP) antigen
15724666|NCT05067946|Other|Placebo|GX-19N formulation buffer
15724667|NCT05067933|Drug|VXA-CoV2-1.1-S|COVID-19 (SARS-CoV-2) E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with dsRNA Adjuvant Oral Tablet Vaccine
15724668|NCT05067933|Other|Placebo Tablets|Placebo tablets matching the active vaccine tablets
15724669|NCT05067920|Diagnostic Test|Levels of SARS-COV-2 antibodies|Study of the SARS-COV-2 antibodies of COVID-19 IgM ( day 5th and 14th) and IgG ( day 14th and 28th)
15724670|NCT05067920|Diagnostic Test|rRT-PCR SARS-Cov-2|Real time RT-PCR for COVID-19 diagnosis at day 5th,14th and 28th
15724671|NCT05067920|Diagnostic Test|Hematological and immunological biomarkers|Laboratory data measure at day 5th,14th and 28th: Hemogram, cytokine levels, ratio of CD4 + / CD8 + lymphocytes, and levels of dehydrogenase lactate, ferritin, D-dimer.
15724672|NCT05067920|Diagnostic Test|Mitochondrial DNA|One time quantification mitochondrial DNA haplogroup.
15724673|NCT05067920|Diagnostic Test|SARS-CoV-2 Viral Culturing|Probability of isolating SARS-Cov-2 in cell culture related to CT value above 32.
15724674|NCT05067920|Diagnostic Test|Sequencing COVID-19|Sequencing viral protein spike (S) COVID-19 related to CT value below 15.
15724675|NCT05067907|Procedure|Early physiotherapy|"Respiratory physiotherapy included:
~early and functional mobilization: passive and active mobilization, muscle strengthening, improving independence in activities of daily living (ADL), sitting out of bed, standing, walking;
~patient positioning to achieve better ventilation/perfusion ratio and gas exchange;
~airway clearance;
~aerosol administration;
~invasive mechanical ventilation weaning;
~use of non-invasive mechanical ventilation (NIMV) and continuous positive airway pressure (CPAP);
~tracheostomy management and weaning;
~swallowing assessment;
~management of oxygen delivery;
~lung expansion;
~patient assessment and functional scale administration."
15724676|NCT05067894|Biological|SARS-CoV-2 Protein Subunit Recombinant Vaccine|intramuscular injection
15724677|NCT05067894|Biological|SARS-CoV-2 Inactivated Vaccine|intramuscular injection
15724678|NCT05067881|Procedure|Pulmonary resection|Resection of pneumohematocele
15724679|NCT05067868|Biological|Replagal|Participants will receive Replagal 0.2 mg/kg, intravenous infusion at Day 1 and every 2 weeks.
15724680|NCT05067855|Other|Pilates exercise program group|Pilates exercise program group will do a warm-up for 10 minutes and then perform five exercises includes standing footwork, hundreds with knee straight, articulating bridge, rolling like a ball, plank for 25 minutes. For first three weeks, each player will do 8 repetitions × 3 sets of exercises and for next three weeks, each player will do 15 repetitions × 3 sets of exercises. There will be cool-down for 10 minutes after exercises. Total program will be of 45 minutes.
15724681|NCT05067842|Diagnostic Test|Circulating tumor DNA(ctDNA) level measurement|The ctDNA level will be measured using the Signatera platform developed by Natera, Inc. Signatera is a patient-specific, tumor informed custom-built ctDNA monitoring assay.
15724682|NCT05067829|Device|TOF|TOF monitoring after anesthesia induction
15724699|NCT05067660|Radiation|Current standard template-based salvage therapy|In the group receiving salvage radiotherapy according to current standard of care, radiation will be directed to the prostatic bed and pelvic lymph nodes according to the radiation oncologist's discretion.
15724700|NCT05067647|Device|ENSEAL X1 Curved Jaw Tissue Sealer|ENSEAL X1 curved jaw tissue sealer is used for transecting and sealing vessels during thoracic, urologic, or ENT procedures according to instructions for use.
15724683|NCT05067816|Behavioral|Med-South Lifestyle Program|The Med-South Lifestyle Program (MSLP) is an evidence-based behavior change intervention that translates the PREDIMED (Mediterranean) dietary pattern for a southeastern US population and includes support for increased physical activity. To promote healthy dietary intake and increased physical activity, the intervention incorporates theory-based behavioral approaches targeting self-efficacy, self-regulation, and internal motivation. The MSLP is delivered in 4 monthly counseling sessions with 3 interim phone follow-up contacts. A maintenance phase lasting 6 months follows the 4-month MSLP and includes 2 phone contacts about 2 months apart. Participants are counseled individually, with 2 in-person counseling visits (at the 1st and 4th counseling visit) and 5 total phone contacts. Each participant is provided with program materials in a participant manual, a cookbook, and a local resource manual identifying community resources to support making targeted behavior changes.
15724684|NCT05067790|Drug|Nusinersen|Administered as specified in the treatment arm
15724685|NCT05067777|Procedure|Massage Therapy|Receive SMT
15724686|NCT05067777|Other|Questionnaire Administration|Ancillary studies
15724687|NCT05067777|Procedure|Sham Intervention|Receive light touch control procedure
15724688|NCT05067764|Procedure|Aponeurectomy with grafting|"The lipofilling is performed, once the incisions are closed and is performed with the Puregraft® system.
~The fat graft is taken from the posterior, medial and anterior sides of the arm, by skin puncture. Approximately 10 cc are harvested, allowing a reinjection of about 2 cc per digital radius treated. After conditioning, the fat graft is redistributed to the curettage areas through the skin incisions."
15724689|NCT05067764|Procedure|Aponeurectomy alone|The patient is installed in dorsal decubitus position and the arm to be treated is anesthetized by axillary block. The procedure is performed in the operating room, respecting all the rules of asepsis and safety in force. A tourniquet is placed on the arm to be treated and inflated to 250mmHg. Broken incisions are then made opposite the cords to be excised, which are located by palpation. Once the noble elements have been identified, the excision of the cords and fibrous nodules can be done as completely as possible. Sometimes an arthrolysis procedure is necessary in order to restore extension to a joint that has been fixed in a flexion position for several years. Skin closure is most often possible by direct suture or by means of local fatty skin flaps. In some cases, the surgeon may use total skin grafts, or directed healing in certain areas where direct skin suture is not possible.
15724690|NCT05067751|Device|hearing aid with directionality|Hearing directionality allows users the ability to focus on voices and other signals of interest, reducing background noises that are unimportant.
15724691|NCT05067738|Other|same day discharge|same day discharge
15724692|NCT05067725|Other|CarePath|During an in-clinic patient encounter with a primary care provider (PCP) in any one of the intervention CMSL sites, the BPA is fired when any type of headache or migraine is entered as a diagnosis or chief complaint. The purpose of the headache assessment questionnaire is to assist the PCP in characterizing patients' headache. The Express Lane will help guide PCP decision-making for prescribing medications, lab/image ordering, and referrals. The Ask-a-doc button will provide timely access to a virtual treatment and diagnosis consult with a neurologist.
15724693|NCT05067712|Procedure|Open Surgical Exposure Technique|"A mucoperiosteal palatal flap is elevated off the bone from the premolar to the midline
~The bone covering the crown aspect of the canine is removed until the largest diameter of the crown is exposed
~Follicular tissue is removed from the exposed crown area
~The flap is repositioned back and sutured
~The area over the exposed canine crown is excised leaving a window with the crown uncovered.
~If the tooth is deeply embedded in the bone, a dressing is placed over the uncovered crown and kept in place with sutures.
~The extraction of the primary canine (if present) is made before or in connection with the surgical exposure.
~Ten to fifteen days later the dressing and sutures are removed and the tooth is left to erupt autonomously.
~When the canine has spontaneously erupted above the palatal mucosa an attachment is bonded to the crown and the canine is moved into alignment in the dental arch above the mucosa with orthodontic appliances."
15724694|NCT05067712|Procedure|Closed Surgical Exposure Technique|"A mucoperiosteal palatal flap is elevated off the bone from the premolar to the midline
~The bone covering the crown aspect of the canine is removed until the largest diameter of the crown is exposed.
~Follicular tissue is removed from the exposed crown area.
~An attachment with a chain is bonded to the exposed canine crown.
~The flap is repositioned back and sutured to cover the exposed crown leaving the chain through the palatal mucosa free in the oral cavity
~The extraction of the primary canine (if present) made before or in connection with the surgical exposure
~Ten to fifteen days later the sutures are removed.
~Within days, traction is applied to the canine with orthodontic appliances by means of the chain, and the canine is pulled through the palatal mucosa out to the oral cavity and into alignment in the dental arch."
15724695|NCT05067699|Diagnostic Test|Human 25-Hydroxyvitamin D3 (HVD3) ELISA Kit (96 well)|The serum will be tested by a double-antibody sandwich enzyme-linked immunosorbent assay (ELISA) to assay the level of Human 25Dihydroxy vitamin D（25-OH-D).
15724696|NCT05067673|Other|Dry needling|The dry needling will be performed using disposable stainless steel needles (AGU-PUNT needles of size 0.30x50mm or 0.30x60mm depending on the patient) that will be inserted perpendicularly at the point of major hyperalgesia using the Hong technique. The patient will be in the prone position with a pillow placed in the abdominal region. The area will be cleaned with an antiseptic and allowed to air dry for 3 minutes. After this time, the needle will be inserted at the point indicated by the evaluator before reaching the lumbar multifidus by means of echolocation. Once it is assured that it is in the right place, a total of 10 repetitions are performed. The needle will be removed by depositing it in a needle container and a compression will be removed in the treated area until hemostasis is achieved.
15724697|NCT05067673|Other|Placebo dry needling|Placebo dry needling will be performed with DongBang DB100 Acupuncture Needles which, upon contact with the patient, retract, hiding in the needle handle. The patient will be in the prone position with a pillow in the abdominal region. The area will be cleaned with an antiseptic and allowed to air dry for 3 minutes. At the point indicated by the evaluator, the placebo needle will be placed initially and the introduction of the needle and its location will be simulated with the ultrasound system. 10 repetitions will be performed. The needle will be removed by depositing it in a needle container and a compression will be made in the treated area.
15724698|NCT05067660|Radiation|Stereotactic ablative radiotherapy|Stereotactic ablative radiotherapy (SABR) is a highly focused radiation treatment that concentrates an intense dose of radiation on the recurrent tumorous lesion while limiting the dose to healthy surrounding tissues.
15724701|NCT05067634|Drug|Xcopri|Age groups 12 to <18 will enroll once dosing data is received from Cohort I of the PK analysis of YKP3089C039 study. Age groups 6 to <12 will enroll once dosing data is received from Cohort IIa of the PK analysis of YKP3089C039 study. Age groups 4 to <6 will enroll once dosing data is received from Cohort IIb of the PK analysis of YKP3089C039 study. Age groups 2 to <4 will enroll once dosing data is received from Cohort III of the PK analysis of YKP3089C039 study.
15724702|NCT05067621|Drug|Liraglutide Pen Injector|Liraglutide (Victoza) pen is a subcutaneous injection that contains 18mg of active ingredient. The injection pen can deliver doses of 0.6 mg, 1.2 mg, or 1.8 mg.
15724703|NCT05067621|Drug|Placebo|Injection pen contains excipients.
15724704|NCT05067608|Biological|Control arm receiving normal (never before frozen) platelets as per current clinical practice|Liquid platelets arm (control) and may receive multiple platelet transfusions per thrombocytopenic cycle.
15724705|NCT05067608|Biological|Treatment arm receiving cryopreserved platelets|Cryopreserved platelets arm (treatment) and may receive multiple platelet transfusions per thrombocytopenic cycle.
15724706|NCT05067595|Procedure|Colonoscopy|Undergo lower FMT via colonoscopy
15724707|NCT05067595|Biological|Fecal Microbiota Transplantation|Given upper FMT PO
15724708|NCT05067595|Biological|Fecal Microbiota Transplantation|Undergo lower FMT via colonoscopy
15724709|NCT05067595|Dietary Supplement|Nutritional Supplementation|Given dietary fiber supplementation PO
15724710|NCT05067595|Other|Survey Administration|Ancillary studies
15724711|NCT05067582|Drug|L1-79|tyrosine hydroxylase inhibitor
15724712|NCT05067569|Behavioral|SleepFix mobile application|The SleepFix app is a novel, innovative way to deliver digital brief behavioural therapy for insomnia for adults.
15724713|NCT05067569|Behavioral|Sleep Health Education|These internet-based modules provide an active control intervention consisting of 3 modules provided bi-weekly. The participant will receive a link to this information as each module is made available. Control participants will have full access to these modules for the duration of the study. They reflect basic educational information regarding sleep health for poor sleepers that is otherwise easily accessible on the internet.
15724714|NCT05067556|Behavioral|Acceptance and Commitment Therapy for chronic pain (ACT-CP)|Delivered virtually via Zoom or via telephone on an individual level; 30-minute sessions led by a trained psychologist and occur weekly for 6 weeks.
15724715|NCT05067543|Device|Tornier Perform Humeral - Stem|The PERFORM Humeral System - Stem is a non-constrained prosthesis intended for the total or partial replacement of the glenohumeral articulation.
15724716|NCT05067530|Drug|Palbociclib|CDK4/6 inhibitor
15724717|NCT05067530|Drug|Paclitaxel|Chemotherapy
15724718|NCT05067530|Drug|Carboplatin|Chemotherapy
15724719|NCT05067517|Drug|Nintedanib|Randomized in a 1:1 ratio to either oral nintedanib 150 mg (n=80) or matching placebo (n=80) twice daily.
15724720|NCT05067517|Drug|Placebo|Randomized in a 1:1 ratio to either oral nintedanib 150 mg (n=80) or matching placebo (n=80) twice daily.
15724721|NCT05067491|Behavioral|Augmented reality exposure therapy|Virtual objects will be placed in the patient's visual field, superimposed on their real environment for exposure therapy.
15724722|NCT05067478|Drug|Vibegron|Vibegron 75 milligram (mg) tablet to be administered orally once daily (as per the U.S. label)
15724723|NCT05067465|Dietary Supplement|Selected food groups|"Food groups
~Milk and dairy products
~Whole-grain products (rich in soluble fibers)
~Sausage and processed meat (pork)
~Meat-free sausage and meat alternatives (based on egg, soy)"
15724724|NCT05067452|Other|Food support|Diabetes-tailored food support. Project Open Hand will provide intervention participants twelve weeks of supplemental food support. Food support will consist of a mix of meals tailored for T2DM, and T2DM-healthy groceries, consistent with American Diabetes Association (ADA) guidelines for diabetes healthy diets under the responsibility of a registered dietitian. All food support will be home delivered.
15724725|NCT05067452|Other|Case-management|"Project Open Hand client services staff will conduct three case management sessions with the participant. The first session will initiate food services and ensure orientation to the intervention and set up delivery; the second session will support the participant with any issues related to the intervention (logistical or nutrition-related, with referral to the POH registered dietitian as needed); the third session will provide transition from the intervention, connect the participant with local food resources, and ensure a warm hand-off to nutrition"
15724730|NCT05067426|Other|Exercise|high-intensity interval training sessions
15724731|NCT05067413|Procedure|Transanterior obturator nerve gateway approach|Distal rectal transection of cases in the experimental group will be performed using transanterior obturator nerve gateway approach
15724732|NCT05067413|Procedure|Total mesorectal excision approach|Distal rectal transection of cases in the control group will be performed using total mesorectal excision approach
15724733|NCT05067387|Drug|Placebo|Oral placebo
15724734|NCT05067387|Drug|THC|Oral THC (20 mg)
15724735|NCT05067387|Drug|CBD|Oral CBD (20 mg)
15724736|NCT05067387|Drug|THC + CBD|Oral THC (20 mg) + CBD (20 mg)
15724737|NCT05067361|Procedure|Aerobic Exercise|Jogging was performed for 20 minutes. Jogging was performed by experimental group for 3 weeks and 4 sessions per week.
15724738|NCT05067361|Procedure|Ball Exercises|Ball exercises like stability ball roll, stability ball hug, stability ball catching, ball throwing and ball tapping exercises were for 10 minutes. Ball exercises was performed by both groups for 3 weeks and 4 times per week .
15724739|NCT05067348|Drug|Tocilizumab Injectable Product|Participants will receive IV tocilizumab
15724740|NCT05067335|Drug|Romosozumab|Subjects will receive romosozumab in a specified sequence during the treatment Period.
15724741|NCT05067335|Drug|Placebo|Subjects will receive Placebo in a specified sequence during the treatment Period.
15724742|NCT05067322|Device|Minecraft|A game played within the videogame Minecraft
15724743|NCT05067309|Drug|Letrozole 2.5mg|Missed abortion received letrozole then misoprostol
15724744|NCT05067296|Other|By TVS|Uses of TVS to diagnosis of Cesarean section niche in patients with abnormal uterine bleeding
15724745|NCT05067283|Drug|MK-1084|Oral dose of 25 or 50 mg tablets
15724752|NCT05067257|Drug|Resiniferatoxin|Resiniferatoxin is a compound purified from natural sources
15724753|NCT05067257|Drug|Placebo|Vehicle solution
15724754|NCT05067244|Drug|MDMA|MDMA assisted psychotherapy
15724755|NCT05067218|Device|buzzy device|bee shaped with wings could be frozen.
15724756|NCT05067218|Other|Conventinal anasthesia|normal technique of injection
15724757|NCT05067205|Procedure|Carpal tunnel release surgery|Preoperative, 3 days, 2 weeks, 4 weeks and 24 weeks postoperatively
15724758|NCT05067166|Drug|Ansuvimab|single infusion 50 mg/kg IV
15724759|NCT05067153|Drug|Fragmin 5000 UNT in 0.2 ML Prefilled Syringe|30 days postoperative prophylactic treatment.
15724760|NCT05067140|Drug|ARV-766|Daily dosages are determined by cohort review committee after initial starting dose cohort and each subsequent cohort completes 28 days of treatment.
15724761|NCT05067127|Drug|Pegcetacoplan|Complement (C3) Inhibitor
15724762|NCT05067127|Other|Placebo|Sterile solution of equal volume to active arm
15724763|NCT05067114|Device|Screening, detection and referral for atrial fibrillation|In-pharmacy cardiovascular risk assessment plus AliveCor KardiaMobile reading
15724764|NCT05067101|Procedure|Capsule Sparing Cystectomy|Adopt endoscopic enucleation technology to preserve the prostate capsule and part of the urinary control support structure to help restore urinary control and erectile functions
15724765|NCT05067101|Procedure|Conventional Radical Cystoprostatectomy|According to the consensus standard program, remove the accessory tissues including the bladder, prostate and seminal vesicles
15724767|NCT05067075|Device|Blinded CGM|CGM that records blood glucose but is not visible to patient or provider in real-time
15724768|NCT05067062|Dietary Supplement|New Zealand blackcurrant extract|Capsules taken daily or intermittent
15724769|NCT05067049|Device|Connected application arm|"patients have to respond different questionnaires about their quality of life on the mobile app.
~And follow-up visits with the physicians as usual"
15724770|NCT05067049|Device|Unconnected arm|Follow-up visits with the pysicians as usual
15724771|NCT05067023|Diagnostic Test|MRI scan|All participants will undergo 1 DCE-MRI scan.
15724772|NCT05067010|Other|Detailed ophthalmologic examination|"Visual acuity
~Eye pressure measurement
~Eye crystalline examination
~Fundus examination
~Optical coherence tomography of the retina
~Retinophotos"
15724773|NCT05066997|Drug|Active treatment arm: OCS-01 (dexamethasone)|The interventional drug OCS-01 eye drops will be dispensed in single dose containers for each subject to have enough medication until the next visit
15724774|NCT05066997|Drug|Vehicle|The vehicle drug (placebo) eye drops will be dispensed in single dose containers for each subject to have enough medication until the next visit
15724775|NCT05066984|Other|structured, multidisciplinary and personalized post-ICU care|Structured, personalized and multidisciplinary post-ICU care tailored to patients' health problems initiated by ICU clinicians and coordinated by GPs.
15724776|NCT05066971|Combination Product|Self-adjustment of medication|Each week, based on the information provided by HM (heart rate and hours of activity each day), the rate control medication is adjusted to increase the total of activity time.
15724777|NCT05066958|Biological|boost anti-viral immunity after T-cell depleted HSCT|"Registration and informed consent sign
~Screening clinical and laboratory examination, assessment of compliance with inclusion criteria
~Survey of the recipient and potential donors
~Donor selection
~The study of the immune response to relevant antigens in the donor and recipient
~Pre-transplant conditioning
~Stimulation of the donor and apheresis of peripheral blood mononuclear cells
~Graft processing
~The manufacturing of cell product
~Transplant Infusion
~Antigen-primed memory DLI infusion
~Inpatient care until day +30
~Outpatient monitoring and screening"
15724778|NCT05066945|Other|Observation|observe the association of ctDNA with efficacy of treatment
15724779|NCT05066932|Other|Additionnal blood samples|Additionnal blood samples
15724782|NCT05066906|Device|Use of Identifor assessment tool and Companion app|"Identifor pinpoints what players excel at by using objective metrics and quantifiable data to collect information relevant to employment, including Multiple Intelligence, Executive Function, and personality themes.
~Companion is a 24/7 personalized aide for teens and adults iwth special needs that uses and artificial intelligence avatar to have back-and-forth conversations with users in a meaningful way to support the user in different domains of their everyday lives including public transit, managing personal schedules, and money management."
15724783|NCT05066906|Other|Referral to employment agencies|Standard referral to employment agencies based on an individual's background, skillset, and preferences
15724784|NCT05066893|Other|telehealth visits|intensive visits with doctor
15724785|NCT05066880|Other|Exercise training|Exercise training for 8 weeks
15724786|NCT05066867|Other|Smart sharps bin - collects data on compliance|collects compliance data
15724787|NCT05066854|Procedure|integron research|"Patients with suspected UTI with fever will be screened at their admission to the pediatric ED.
~Urine samples will be sent to the laboratory for culture and integron PCR according to routine practice.
~Results of the integron search will be given to the investigator. Patients in the experimental group with a positive or uninterpretable PCR will also receive an empirical antibiotic treatment based on the usual practice of each center according to the GPIP guidelines.
~Patients in the experimental group with a negative PCR will receive a treatment with SXT at the recommended dose."
15724788|NCT05066854|Procedure|usual practice|"Patients with suspected UTI with fever will be screened at their admission to the pediatric ED.
~Patients in the control group will receive an empirical antibiotic treatment based on the usual practice of each center according to the GPIP guidelines."
15724789|NCT05066841|Drug|CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang)|CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) for 12 weeks
15724790|NCT05066841|Drug|10% CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang)|10% CM (Ma-Hsing-Kan-Shih-Tang in combination with Liu-Jun-Zi-Tang) and 90% starch for 12 weeks
15724791|NCT05066828|Other|two pieces obturator|patient received two pieces obturator connecting by magnet attachment
15724792|NCT05066815|Other|Vita Enamic (Hybrid dental ceramic)|Vita Enamic (Hybrid dental ceramic) is provided as blocks to be milled using Computer aided design/Computer aided manufacturer (CAD/CAM) technology.
15724793|NCT05066802|Drug|neoadjuvant modified FOLFIRINOX|oxaliplatin 85 mg/m2 D1 + leucovorin 400mg/m2 D1 + irinotecan 150 mg/m2 D1 + 5-FU 2,000 mg/m2 42~46h continuous infusion, every other week for 6 cycles (12 weeks) before surgery.
15724794|NCT05066789|Device|Type of stent|1:1 randomization to biodegradable polymer DES (Orsiro Mission) and polymer-free DCS (Biofreedom)
15724795|NCT05066789|Drug|Duration of DAPT|1:1 randomization to 1-month DAPT thereafter prasugrel monotherapy and 12-month DAPT (aspirin + prasugrel)
15724796|NCT05066763|Other|Non-interventional|non-interventional
15724797|NCT05066750|Behavioral|Mindful breathing|Participants watch a 10 minute mindful breathing video
15724798|NCT05066750|Behavioral|Control video|Participants watch a 10 minute control video
15724799|NCT05066737|Procedure|lateral suspension via V-NOTES surgery|pop-q, pisq-12 assesment of patients with pelvic organ prolapse before and 6 or 12 month after lateral suspension surgery performed via V-NOTES technique.
15724800|NCT05066724|Drug|Centanafadine|400 mg total daily dose Centanafadine Sustained Release, oral tablets
15724801|NCT05066698|Biological|ST266|Topical ocular application: one drop four times a day for eight weeks
15724802|NCT05066698|Other|0.67% Sodium Chloride Ophthalmic Solution|Topical ocular application: one drop four times a day for eight weeks
15724803|NCT05066698|Biological|Open-label ST266|Open label extension for non-healers after completion of double-blind treatment phase: topical ocular application of one drop four times a day for eight weeks
15724804|NCT05066685|Other|All participants|All the particpants enrolled in the brolucizumab Patient Support Services (PSS) program
15724805|NCT05066672|Drug|NV-5138|NV-5138 is a novel, orally bioavailable, selective, direct activator of mTORC1 cellular signaling
15724806|NCT05066672|Drug|matched placebo|matched placebo oral capsules
15724807|NCT05066646|Drug|CT103A|CT103A consists of autologous T lymphocytes transduced with anti-BCMA CAR lentiviral vector that containing a unique CAR structure with a fully human single-chain variable fragment (scFv).
15724808|NCT05066633|Drug|Metoprolol Succinate|Metoprolol Succinate will be in the form of tablets and will be administered orally once daily. The dose will depend on the patient's weight category. Subject should take their treatment at a consistent time each day to promote compliance. IMP will be up titrated. Every two weeks the patients will be given the higher dose of metoprolol succinate or placebo accordingly to scheme.
15724809|NCT05066633|Drug|Placebo|Placebo will be in the form of identical tablets and will be administered orally once daily.
15724810|NCT05066620|Drug|Chinese herbal medicine FYTF-919|Oral liquid 33ml TID (for patients who are unconscious or dysphagia, a dose of 25ml * Q6H will be given through nasal feeding)
15724811|NCT05066607|Drug|Isatuximab|Patient will receive the association of Isatuximab, Pomalidomide and Dexamethasone during 9 or 12 cycles.
15724812|NCT05066594|Device|Transoral incisionless fundoplication|The intervention of transoral incisionless fundoplication using the EsophyX (EndoGastric Solutions) system allows, through the endoscopic route, the creation of a cardial neovalve of approximately 270 ° by placing 20-28 polyethylene sutures on the cardial circumference, resulting in an anti-reflux plastic functionally similar to that obtained with the surgical fundoplication.
15724813|NCT05066581|Device|Live Chat|Subjects from the intervention group will be able to ask for a medical intervention if needed with the phisycians from the sleep unit. After the following period, we expect to see better sleep habits in this group when compared to the no intervention one
15724814|NCT05066568|Device|Active Tracranial Direct Current Stimulation|Site: dorsolateral prefrontal cortex. F3 anode and F4 catode. Electrode area: 35cm2 Current Intensity: 2mA Stimulation time: 20 min The current ramps up during 30 seconds reaching 2mA, staying this way until the last 30 seconds of stimulation, in wich the current slowly decreases to zero.
15724815|NCT05066568|Other|Hypnotic analgesia suggestion|The hypnotic induction protocol was standardized to be applied equally to all subjects. The protocol for hypnotic analgesia begins with an induction with a sequence of suggestions for the subjects to focus their attention on an individual stimulus, associated with progressive relaxation. After that, direct suggestions are given for comfort and pain reduction. The intervention lasts 20 minutes, with 12 minutes of induction and 8 minutes of hypnotic suggestions to reduce pain and leave the trance.
15724816|NCT05066568|Behavioral|Rest|The patient is asked to remain seated still for 20 minutes.
15724817|NCT05066568|Other|Active tDCS + Hypnotic analgesia suggestion|"Site: dorsolateral prefrontal cortex. F3 anode and F4 catode. Electrode area: 35cm2 Current Intensity: 2mA Intervention time: 20 min The current ramps up during 30 seconds reaching 2mA, staying this way until the last 30 seconds of stimulation, in wich the current slowly decreases to zero.
~The hypnotic induction protocol was standardized to be applied equally to all subjects. The protocol for hypnotic analgesia begins with an induction with a sequence of suggestions for the subjects to focus their attention on an individual stimulus, associated with progressive relaxation. After that, direct suggestions are given for comfort and pain reduction. The intervention lasts 20 minutes, with 12 minutes of induction and 8 minutes of hypnotic suggestions to reduce pain and leave the trance."
15724818|NCT05066568|Other|Sham tDCS + Hypnotic analgesia suggestion|Site: dorsolateral prefrontal cortex. F3 anode and F4 catode. Electrode area: 35cm2 Current Intensity: 0mA Intervention time: 20 min The current is turned off after 30 seconds. The hypnotic induction protocol was standardized to be applied equally to all subjects. The protocol for hypnotic analgesia begins with an induction with a sequence of suggestions for the subjects to focus their attention on an individual stimulus, associated with progressive relaxation. After that, direct suggestions are given for comfort and pain reduction. The intervention lasts 20 minutes, with 12 minutes of induction and 8 minutes of hypnotic suggestions to reduce pain and leave the trance.
15724819|NCT05066542|Behavioral|NDPP + Basketball (BB)|DPP Hoops: Participants in this arm will participate in the traditional NDPP program delivered virtually by certified NDPP coaches along with virtual fitness sessions and in-person basketball sessions. During Months 1-4, participants will attend a 60-minute virtually facilitated session of the NDPP curriculum, followed by a 30- minute virtual fitness session. During that same week, participants will meet in person, for a 90-minute BB session. During Months 5-8, virtual NDPP curriculum sessions will be held every two weeks and there will no longer be a 30-minute online fitness session succeeding the session. During this same four-month period, 60-minute, in-person BB sessions will be held weekly. During Months 9-12, participants will attend a monthly 60-minute NDPP curriculum session and biweekly 60-minute in-person BB sessions. Participants will submit a weekly weight report during the 12 month participation and will complete the ASA 24 hour food recall every 90 days.
15724820|NCT05066542|Behavioral|NDPP Standard of Care SOC|DPP: Participants in this arm will participate in the traditional NDPP program delivered virtually by certified NDPP coaches. During Months 1-4 participants will attend a 60-minute virtually facilitated session of the NDPP curriculum. During Months 5-8, virtual NDPP curriculum sessions will be held every two weeks. During Months 9-12, participants will attend a monthly 60-minute NDPP curriculum session. Participants will submit a weekly weight report during the 12 month participation and will complete the ASA 24 hour food recall every 90 days.
15724821|NCT05066529|Procedure|dry-needling|Dry needling is a technique in which a fine needle is used to penetrate the skin, subcutaneous tissues and muscles to mechanically disrupt tissue without the use of anesthesia. Treatment is often used to treat myofascial trigger points.
15724822|NCT05066516|Drug|FCDP, dapagliflozin 10mg/linagliptin 5 mg or co-administration of a single dose of dapagliflozin and linagliptin|FCDP, dapagliflozin 10mg/linagliptin 5 mg or ICs, co-administration of a single dose of dapagliflozin and linagliptin
15724823|NCT05066503|Dietary Supplement|260279 active study product|The active study product (20g per serving) contains 13.6g of amino acids and natural flavors, citric acid, malic acid, and stevia for flavoring.
15724824|NCT05066503|Dietary Supplement|260279 placebo|A drink made of flavored, sweetened water.
15724825|NCT05066490|Other|Endurance exercise|Treadmill training at moderate intensity.
15724826|NCT05066490|Other|Resistance exersises.|Resistance exercises using the 10 repetition maximum.
15724827|NCT05066477|Dietary Supplement|CalGo|CalGo is a natural marine collagenic bone powder from salmon. The bone powder is a 100 % microcrystalline hydroxyapatite form of calcium and phosphorus. Furthermore it contains collagen type 2 and is enriched with vitamin D3.
15724828|NCT05066477|Other|Placebo|Pure maltodextrin
15724829|NCT05066464|Other|Fluid Resuscitation|Fluid Resuscitation for Suspected Sepsis in Paediatric Emergency Departments
15724830|NCT05066451|Other|%5 dextrose prolotherapy|"Patients in the study group will receive a total of 3 sessions of prolotherapy solution containing 5% dextrose at the beginning(0.) 3rd week and 6th week.
~Prolotherapy was planned with the multiplanar injection technique (peppering technique) after palpating the most sensitive point on the lateral epicondyle and entering the lateral epicondyle from here and ensuring bone contact."
15724831|NCT05066451|Other|%15 dextrose prolotherapy|"Patients in the study group will receive a total of 3 sessions of prolotherapy solution containing 15% dextrose at the beginning(0.) 3rd week and 6th week.
~Prolotherapy was planned with the multiplanar injection technique (peppering technique) after palpating the most sensitive point on the lateral epicondyle and entering the lateral epicondyle from here and ensuring bone contact."
15724832|NCT05066438|Behavioral|Antenatal hand expression|Standardized counselling and provision of information/resources on the practice of antenatal hand expression to encourage milk let down and colostrum production/collection.
15724833|NCT05066425|Dietary Supplement|Soluble Corn Fiber|Participants will be asked to consume a packet of 22g Soluble Corn Fiber/day for 4 weeks
15724834|NCT05066425|Dietary Supplement|Maltodextrin|Participants will be asked to consume a packet of 22g Maltodextrin/day for 4 weeks
15724835|NCT05066412|Other|CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology|CD45RAneg cells, prepared from mononuclear cell leukapheresis by CliniMACS® technology
15724836|NCT05066386|Other|Modified RCRI risk stratification|"The objective of the study is to compare the predictive value of RCRI and substitution of the DM on insulin component with HH ratio for 30- and 90-day mortality, and postoperative acute myocardial injury(AMI) and acute kidney injury(AKI)."
15724837|NCT05066373|Drug|EDP1815 capsule A|EDP1815 capsule A is an orally administered, pharmaceutical preparation of a single strain of Prevotella histicola. The capsule is radio-labeled with approximately 4 MBq 99mTc-DTPA
15724838|NCT05066373|Drug|EDP1815 capsule B|EDP1815 capsule B is an orally administered, pharmaceutical preparation of a single strain of Prevotella histicola. The capsule is radio-labeled with approximately 4 MBq 99mTc-DTPA
15724839|NCT05066373|Drug|EDP1815 tablet|EDP1815 tablet is an orally administered, pharmaceutical preparation of a single strain of Prevotella histicola. The capsule is radio-labeled with approximately 4 MBq 99mTc-DTPA
15724840|NCT05066360|Diagnostic Test|serum antimullerian hormone|serum antimullerian hormone will be analyzed for all participants
15724870|NCT05066035|Drug|Neostigmine|"The study investigators administer neostigmine at the end of operation to reverse neuromuscular blockade, and the routine dose of the intravenous neostigmine is 0.05 mg/kg and atropine 0.02 mg/kg. The dose is given in a single syringe, and later they administer this reversal medication before extubation.
~In the case of a residual block, the neostigmine group of patients receives a rescue dose of neostigmine at a dose of 0.03 mg/kg in the operating room fifteen minutes before discharge."
15725011|NCT05064696|Other|Non-stick gauze dressing|Group 1 (Control group): surgical site will be dressed with a standard non-stick gauze dressing
15725012|NCT05064696|Device|PICO dressing|Group 2 (Treatment group): surgical site will be dressed with PICO dressing
15724841|NCT05066347|Device|Cardiophone|"Cardiophone (ER920W event recorder, Braemar Inc.) is an external loop recorder that has the monitoring and cell phone technology in one unit. Cardiophone evaluates all cardiac beats and rhythm abnormalities that are detected as per the algorithm programmed into the device. These abnormalities are then automatically and immediately transmitted to a central monitoring station in Windsor, Ontario (Canadian Cardiac Care) without the need of any patient intervention (device-triggered transmission). Additionally, the cardiac rhythm can also be transmitted to the monitoring station immediately in the event the patient experiences symptoms, by the touch of a button on the device (patient-triggered transmission).
~All patients with outpatient cardiac monitoring will be given an option of adding an external Global Positioning System (GPS) tracker device in addition to the cardiac rhythm monitoring device in the event they are incapacitated after the syncope and unable to call 911."
15724842|NCT05066334|Drug|Autologous BM-MSC|intradiscal injection of autologous bone marrow mesenchymal stromal cells
15724843|NCT05066334|Procedure|Sham|local anaesthesia, no disc injection, no placebo injection
15724844|NCT05066321|Behavioral|Mindfulness Oriented Recovery Enhancement Sessions|The MORE intervention will involve 8 weekly sessions (approximately 1 hour each), during which participants will be taught how to use mindfulness skills to regulate addiction severity, pain, and stress.
15724845|NCT05066308|Drug|CBD|Epidiolex, an agent within the anti-epileptic drug class, will be used. Epidiolex, Greenwich Biosciences Inc.'s CBD formulation, is a 100 mg/mL purified oral solution, dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring. The drug is formulated from extracts prepared from Cannabis sativa L. plants that have a defined chemical profile and contain consistent levels of CBD as the principal phytocannabinoid. Extracts from these plants are processed to yield pure (>95%) CBD that typically contains less than 0.5% (w/w) THC. Cannabidiol is the active ingredient in Epidiolex; inactive ingredients include dehydrated alcohol, sesame seed oil, strawberry flavor, and sucralose. Of note, CBD has no psychoactive properties.
15724846|NCT05066308|Other|Placebo|Placebo CBD will be identical to the active CBD, a 100 mg/mL purified oral solution, dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring, but with no CBD.
15724847|NCT05066256|Diagnostic Test|Left ventricular diastolic function|Transthoracic echocardiography Mitral E/e'
15724848|NCT05066256|Diagnostic Test|Inferior vena cava variation|Inferior vena cava variation from ultrasound
15724849|NCT05066243|Other|questionnaire|this study is to develop a questionnaire for vulval conditions
15724850|NCT05066230|Drug|KSI-301|Intravitreal injection
15724851|NCT05066230|Other|Sham injection|The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study.
15724852|NCT05066217|Drug|Clemizole HCl|Double-Blind Randomized
15724853|NCT05066217|Drug|Placebo to match EPX-100|Double-Blind Randomized
15724854|NCT05066204|Other|Sequence of teaching-/learningmethod|see: arm/group descriptions
15724855|NCT05066178|Behavioral|CAS Treatment for Minimally Verbal Children with Autism|Treatment involves principles of motor learning embedded in a naturalistic developmental milieu
15724856|NCT05066165|Genetic|Arm 1: NTLA-5001|"Autologous WT1-directed TCR T cells engineered ex vivo using CRISPR/Cas9 as intravenous infusion.
~Cyclophosphamide and Fludarabine will be administered on Day -5, -4, and -3 as intravenous infusion."
15724857|NCT05066165|Genetic|Arm 2: NTLA-5001|"Autologous WT1-directed TCR T cells engineered ex vivo using CRISPR/Cas9 as intravenous infusion.
~Cyclophosphamide and Fludarabine will be administered on Day -5, -4, and -3 as intravenous infusion."
15724858|NCT05066152|Dietary Supplement|Lactobacillus rhamnosus GG (ATCC 53103)|One probiotic drop contained a formulation of 1x109 Cfu Lactobacillus rhamnosus GG (LGG; ATCC 53103)
15724859|NCT05066152|Dietary Supplement|Placebo|Carrier material of probiotic product, not containing bacterial strain, similar appearance as the probiotic
15724860|NCT05066139|Other|EPODIG-G program (coordination of supportive care)|EPODIG-G program includes: a nutritional evaluation (laboratory tests: albumin, pre-albumin, C reactive protein and vitamin D dosage, nutritional status, Handgrip test, Simple Evaluation of Food Intake (SEFI), spontaneous food intake evaluation) ; a medication reconciliation ; physical therapy (Six Minute Walk Test)
15724861|NCT05066126|Behavioral|Mixed-Presentation of Content|Participants in the high-mixed presentation of content conditions will receive a social media feed that varies greatly between topics, so that each subsequent post is on a different topic. In the low-mixed presentation of content condition, participants will be shown posts on any given topic grouped together.
15724862|NCT05066113|Device|Radiofrequency-Based treatment|"RF-based treatments use electrothermolysis to deliver heat energy to targeted structures in the skin, such as hair follicles or glands by the use of insulated needles. The investigators will use radio frequency based treatment on a pre-selected skin area (about 3cm x 3cm or 1 ¼ x 1 ¼ inches in size) on either your left or right underarm that is eligible for assessment, study treatment, and biopsy.
~Participants will receive clinical assessments, photography, questionnaires, up to 3 treatments of RF-based selective electrothermolysis to pre-selected areas of the axillary skin, up to 2 4-mm skin biopsies for up to 5 study visits."
15724863|NCT05066100|Other|Prenatal Use of Supple Cups|For pregnant women identified with FIRN and providing consent to participate in this study, Supple Cup usage will be initiated at 32 weeks gestation to begin to elongate the nipples in preparation for breastfeeding.
15724864|NCT05066087|Behavioral|DAHLIA treatment|6 weeks; CBT/ ACT/ process-based treatment; micro-learning format with 4 digital micro-sessions per week; exposure as the core process; guidance to be OPEN, AWARE, ACTIVE; weekly contact with therapist; booster sessions after 2- and 4 months;
15724865|NCT05066087|Other|Treatment as usual|Usual pain treatment; defined post-hoc based on what patients receive
15724866|NCT05066074|Procedure|Distal Radial Vascular Access|Distal Radial Vascular Access
15724867|NCT05066061|Other|control arm|usual process
15724868|NCT05066061|Other|anxiolytic and analgesic gas|add relaxing gas
15724869|NCT05066061|Device|Virtual reality mask|use Virtual reality mask Oculus Quest with age-appropriate software
15724954|NCT05065242|Behavioral|Cognitive Behavioural Therapy|Sleep restriction, Stimulus control, sleep hygiene and cognitive techniques to handle sleep disturbing thoughts.
15725639|NCT05059509|Biological|FB825|FB825, 5mg/kg, by 1 hour IV infusion on Day 1
15724871|NCT05066035|Drug|Sugammadex|The study investigators administer the routine full-dose neostigmine reversal medication and three minutes later, they administer an intravenous bolus dose of 1 mg/kg sugammadex in a different syringe prepared earlier as a reversal agent. The anesthesia team considers using an intravenous rescue dose of 1 mg/kg sugammadex for this group of patients in the recovery room if patients do not show a complete recovery of TOF ratio equal to >0.9 in the recovery room before discharge to the ward.
15724872|NCT05066022|Biological|CT0590 CAR T Cells|Dose-escalated CAR T cells infusion
15724876|NCT05065996|Diagnostic Test|Aortic MRI + 4D flow MRI|Together with routine aortic MRI specific 4D flow MRI sequence will be done.
15724877|NCT05065983|Biological|CHIKV VLP, adjuvanted|Adjuvanted formulation includes Alhydrogel
15724878|NCT05065970|Drug|Felzartamab|anti-CD38+ monoclonal antibody
15724879|NCT05065970|Other|Placebo|Placebo comparator
15724880|NCT05065957|Drug|D07001-softgel capsules + Xeloda (or TS-1)|"D07001-softgel capsules: 3 times per week (on Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of a 21-day cycle, 9 doses per cycle).
~Xeloda (or TS-1): twice daily for 14 consecutive days followed by 7 days rest (1 treatment cycle)"
15724881|NCT05065957|Drug|mFOLFOX|intravenous infusion on Day 1 for 14-day cycle
15724882|NCT05065944|Behavioral|Telemedicine|Pre-anesthesia assessment (history and physical examination) via telemedicine. Intervention is a one-time telemedicine clinic visit for approximately 30 minutes to 1 hour. Individual patients will be randomized to telemedicine and that visit will be scheduled via the Zoom video conferencing platform.
15724883|NCT05065944|Behavioral|In Person Visit|Pre-anesthesia assessment (history and physical examination) in person at Moffitt Cancer Center (usual care)
15724884|NCT05065931|Other|Auxiliary diagnostic system by AI-CDSS|Helping clinicians to make diagnoses by using CDSS based-on AI
15724885|NCT05065918|Behavioral|sexual violence and alcohol use harm reduction text message content|The multi-target sexual violence harm reduction and alcohol use intervention will use a similar model to the alcohol use reduction intervention previous developed and implemented. Students will be: 1) queried via TM prior to typical drinking days regarding both alcohol use and SV harm reduction goal setting; 2) provided with goal reminders during drinking period; and 3) assessed for goal attainment and given feedback following drinking episodes. As with the control condition, post-drinking assessment happens weekly on Sundays. Monday thru Saturday participants will randomly receive or not receive one appropriate message pathway from the message library using the pre-determined pathways for messages.
15724886|NCT05065918|Behavioral|alcohol use reduction content|"The control condition will be a previously tested TM-delivered alcohol use reduction intervention. Prior to typical drinking occasions, individuals planning a drinking event are prompted to consider committing to a drinking limit goal, i.e.: Would you be willing to set a goal to drink less than X drinks when drinking?. Based on willingness to commit to the goal, a feedback message is provided. During typical drinking periods, individuals receive a goal reminder. Each week, the program provides goal success/failure feedback or drinking quantity feedback. For example, those occasions where an individual committed to a drinking limit goal triggers either messages to reinforce goal successes or reframe goal failures. When an individual did not commit to a drink limit goal, they are provided feedback based on alcohol quantity (e.g. high risk drinking feedback)."
15724887|NCT05065905|Drug|Interferon-Gamma|received by microbiological synthesis; specific antiviral activity on cells is 2x10*7 Units per mg of protein
15724890|NCT05065866|Drug|CC-486|"Patients will be treated at the following dose levels:
~Duvelisib CC-486 Dose Level 15 mg twice daily 100mg daily -1 25 mg twice daily 100mg daily 1 50 mg twice daily 100mg daily 2 75 mg twice daily 100mg daily 3 75 mg twice daily 200mg daily 4 75 mg twice daily 300mg daily 5
~After the first two cycles of treatment, the dose of Duvelisib will be dropped to 25 mg twice daily irrespective of the starting dose level unless the patient is at dose level -1 then they will stay on that dose level after the initial 2 cycles"
15724891|NCT05065866|Drug|Duvelisib|"Patients will be treated at the following dose levels:
~Duvelisib CC-486 Dose Level 15 mg twice daily 100mg daily -1 25 mg twice daily 100mg daily 1 50 mg twice daily 100mg daily 2 75 mg twice daily 100mg daily 3 75 mg twice daily 200mg daily 4 75 mg twice daily 300mg daily 5
~After the first two cycles of treatment, the dose of Duvelisib will be dropped to 25 mg twice daily irrespective of the starting dose level unless the patient is at dose level -1 then they will stay on that dose level after the initial 2 cycles"
15724892|NCT05065853|Diagnostic Test|urine self-sampling group|collection of urine and vaginal samples
15724893|NCT05065853|Diagnostic Test|clinician-collected cervical sample group|A clinician takes a smear from cervix according to standard routine
15724894|NCT05065840|Behavioral|CDC 4 Pillars Program|The CDC's 4 Pillars Transformation Program (4 Pillars Program) is a robust and empirically supported strategic approach that promotes the uptake of adult vaccinations and addresses facilitators and barriers at the patient, provider, and clinic level. This multi-level, evidence-based intervention has been successfully utilized to increase HPV vaccination in the general population and is primed to be tested in the high-risk HIV population, particularly PLWH in the rural South. This proposal seeks to expand the success of the 4 Pillars Program and tailor, refine, and implement in the HIV positive population who are at extraordinarily high risk for HPV-related cancers and can obtain the most benefit from the vaccine.
15725677|NCT05059171|Device|OneSahpe single file|The rotary motion of OneShape single file
15724895|NCT05065814|Other|Systemic lupus erythematosus group|Demographic information of systemic lupus erythematosus who accepted to participate in the study will be obtained, and respiratory and peripheral muscle strength and exercise capacity of the patients will be evaluated with a 6-minute walking test. Patients will be asked to complete the International Physical Activity Questionnaire, the numerical pain questionnaire, the Short Form-36, and the Hospital Anxiety and Depression Questionnaire. In addition, Modified Medical Research Council Dyspnea Scale will be applied by the interviewer.
15724896|NCT05065814|Other|Systemic sclerosis group|Demographic information of Systemic sclerosis who accepted to participate in the study will be obtained, and respiratory and peripheral muscle strength and exercise capacity of the patients will be evaluated with a 6-minute walking test. Patients will be asked to complete the International Physical Activity Questionnaire, the numerical pain questionnaire, the Short Form-36, and the Hospital Anxiety and Depression Questionnaire. In addition, Modified Medical Research Council Dyspnea Scale will be applied by the interviewer.
15724897|NCT05065814|Other|Healthy control group|Healthy individuals with no chronic diseases who agreed to participate in the study and gave their consent will be included in the study.
15724898|NCT05065801|Combination Product|GABRINOX|Patients in the experimental arm received sequential treatment: 3 cycles of GEMBRAX followed by 2 cycles of FOLFIRINOX
15724899|NCT05065801|Combination Product|FOLFIRINOX|Patients in this arm received reatment: 3 cycles of FOLFIRINOX
15724900|NCT05065788|Other|data collection|data collection
15724901|NCT05065775|Device|Dexmedetomidine|Single intranasal dexmedetomidine dose of 100 µg. Intranasal dexmedetomidine will be administered shortly after induction of anesthesia using a mucosal atomization devise (LMA MAD Nasal™)
15724902|NCT05065736|Drug|18F-Clofarabine|The participants enrolled will receive a baseline CFA PET/CT evaluation. Then, the participants will undergo the routine follow up would normally occur for their cancer and its treatment. If this routine follow up and care involves repeat imaging of the cancer, then the CFA PET/CT scan will be repeated at that time (timed according to standard-of-care follow-up imaging), which is expected between a month to about 4 months after the first CFA PET/CT scan. The study period will end 24 hours after this repeat PET/CT scan.
15724904|NCT05065697|Other|Brain MRI|Brain MRI will be scheduled within three days before the procedure and within seven days after the procedure, as well as at 6-month follow-up. MRI will be preferably performed using a 3.0-Tesla system unless patients are pacemaker-dependent after the procedure. In such case, a 1.5-Tesla system will be used. The MRI protocol consists of standardized conventional diffusion-weighted MRI (DW-MRI), T2-FLAIR (fluid-attenuated recovery inversion) and SWI (susceptibility-weighted imaging) parameters.
15724905|NCT05065671|Drug|Tolcapone 100 MG|Tolcapone 100 mg by mouth once
15724906|NCT05065671|Drug|Duloxetine 30 MG|Duloxetine 30 mg by mouth once
15724907|NCT05065658|Drug|Posaconazole|Intravenous posaconazole prophylaxis
15724908|NCT05065645|Drug|Angiotensin Converting Enzyme 2|SAD: single dose; MAD: dosage 2x daily for 7 days
15724909|NCT05065645|Drug|Sodium chloride|SAD: single dose; MAD: dosage 2x daily for 7 days
15724910|NCT05065632|Diagnostic Test|Wantai kit Elisa|to mesure antibodies against SARSCov-2 recombinant antigen
15724911|NCT05065619|Biological|MT-2766 High dose|Subjects will receive two doses of MT-2766 high dose given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once)
15724912|NCT05065619|Drug|Placebo|Subjects will receive two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once)
15724913|NCT05065619|Biological|MT-2766 Low dose|Subjects will receive two doses of MT-2766 low dose given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once)
15724914|NCT05065606|Diagnostic Test|Dual-energy computed tomography|Dual-energy scanner examinations stored in the PACS (medical imagery) at Lariboisière Hospital are to be analyzed retrospectively and prospectively
15724915|NCT05065593|Other|resistance and aerobic exercise|Resistive exercises allow loading the muscle under suitable conditions with various weights or resistances. In order to increase the level of physical fitness with the increase of muscle strength and bone mass in individuals, resistance exercises were preferred. Aerobic exercises, on the other hand, are a special type of exercise that develops both the musculoskeletal system and the cardiovascular system, which includes large muscle groups and should be performed for at least 20 minutes when the heart rate accelerates at certain rates. Aerobic exercise was preferred in order to increase cardiovascular endurance, accelerate fat burning and reduce fatigue.
15724916|NCT05065593|Other|physical activity recommendation|Patients will be informed about the importance of lifestyle change in disease management, walking training will be given to increase their physical activity level, and participants will be asked to follow a 45-minute walking program every day within their own means.
15724917|NCT05065580|Procedure|pre-test|no OMT treatment
15724918|NCT05065580|Procedure|post-test|OMT Treatment for 8 weeks
15724919|NCT05065567|Drug|Droperidol|Patients who have been diagnosed with cyclic vomiting syndrome and enrolled in the study will be randomized based on the week to either 2.5mg droperidol IV or haloperidol
15724920|NCT05065567|Drug|Haloperidol|Patients who have been diagnosed with cyclic vomiting syndrome and enrolled in the study will be randomized based on the week to either haloperidol
15724921|NCT05065554|Drug|Acalabrutinib|Dose per protocol, oral twice daily per cycle
15724922|NCT05065554|Drug|Rituximab|Premedications (including acetaminophen, an antihistamine, and a steroid) will be given per institutional guideline Dosage determined per protocol and cycle timepoint, Route IV or SQ per protocol and cycle timepoint, schedule per protocol and cycle timepoint
15724923|NCT05065541|Drug|CC-97489|Specified dose on specified days
15724924|NCT05065541|Drug|[18F]T-401|Specified dose on specified days
15724925|NCT05065541|Drug|[11C]MK-3168|Specified dose on specified days
15724926|NCT05065528|Dietary Supplement|Magnesium|Will receive symptomatic care along with 400 mg supplemental magnesium twice daily for 3 days
15725094|NCT05063968|Drug|XZP-6019 tablet|Tablet is administered orally once on Day 1 and Day 9, respectively
15725095|NCT05063968|Drug|Placebo|Tablet is administered orally once on Day 1 and Day 9, respectively
15725096|NCT05063968|Drug|XZP-6019 tablet|Tablet is administered fasted orally once on Day 1
15724927|NCT05065502|Behavioral|Academic Detailing (AD)|"The National Resource Center for Academic Detailing (NaRCAD) describes AD as an innovative, one-on-one outreach education technique that helps clinicians provide evidence-based care to their patients. Using an accurate, up-to-date synthesis of the best clinical evidence in an engaging format, academic detailers ignite clinician behavior change, ultimately improving patient health. A successful AD visit is highly interactive, always a dialogue, and assesses a clinician's individual needs, beliefs, attitudes, issues, and concerns in order to promote better.[practice]."
15724928|NCT05065502|Behavioral|LEAP|Learn. Engage. Act. Process (LEAP) program is a structured 6-month core curriculum plus 6 monthly collaborative sessions. The LEAP quality improvement program engages frontline teams in sustained incremental improvements of EBPs over a six-month period, allowing space for busy clinicians to learn and immediately apply fundamental QI skills. LEAP encompasses: 1) a structured, accessible curriculum based on the Institute for Healthcare Improvement's (IHI) Model for Improvement and Plan-Do-Study-Act cycles of change; 2) team-based, hands-on learning, and 3) coaching support and a QI network to enhance learning and accountability.
15724929|NCT05065489|Other|No intervention|No intervention
15724930|NCT05065463|Drug|AZD8233|Participants will receive a single subcutaneous (SC) dose of AZD8233 into the region of the abdomen.
15724932|NCT05065437|Other|Active (Virtual reality and spinal stimulation)|Each session is 25 minutes; 5 minutes of setup, and 20 minutes of simultaneous spinal stimulation at the cervical level and immersive virtual experience/gameplay.
15724933|NCT05065424|Drug|IV Atropine and Fentanyl Premedication Arm|"Prior to the LISA procedure, the blinded bedside nurse will infuse IV Atropine, labelled as Atropine/Placebo, over 1 minute, followed by IV fentanyl, labelled as Fentanyl/Placebo, over 20 minutes in the presence of blinded respiratory therapist and primary team provider.
~After medication infusion, a primary team member will perform Less Invasive Surfactant Administration procedure. Infant vital signs, cerebral Near Infrared Spectroscopy values, pain scores will be monitored and recorded during and for 12 hours after the procedure. Level of respiratory support, oxygen requirement and subsequent need for intubation for 24 hours after the procedure will be obtained from the electronic medical record."
15724934|NCT05065424|Drug|IV Normal Saline Placebo Arm|"Prior to the Less Invasive Surfactant Administration procedure, the blinded bedside nurse will infuse IV Normal Saline, labelled as Atropine/Placebo, over 1 minute, followed by a second infusion of IV Normal Saline, labelled as Fentanyl/Placebo, over 20 minutes in the presence of blinded respiratory therapist and primary team provider.
~After Normal Saline infusion, primary team member will perform Less Invasive Surfactant Administration procedure. Infant vital signs, cerebral Near Infrared Spectroscopy values, pain scores will be monitored and recorded during and for 12 hours after the procedure. Level of respiratory support, oxygen requirement and subsequent need for intubation for 24 hours after the procedure will be obtained from the electronic medical record."
15724935|NCT05065411|Drug|Enobosarm & Abemaciclib Combo|Subjects will receive a combo of Enobosarm & Abemaciclib
15724936|NCT05065411|Drug|non-steroidal AI, or steroidal AI (exemestane with or without everolimus) or Fulvestrant|Non-steroidal AI, a steroidal AI (exemestane with or without everolimus), OR fulvestrant
15724937|NCT05065398|Drug|HLX208|450mg bid, take orally
15724938|NCT05065385|Diagnostic Test|INTER-NDA|Neurodevelopmental Screening Test at age 2 years.
15724943|NCT05065359|Drug|Rodatristat Ethyl 300 mg BID|Tablets, oral, 300 mg, BID 14 days
15724944|NCT05065359|Drug|Rodatristat Ethyl 600 mg BID|Tablets, oral, 600 mg, BID 14 days
15724945|NCT05065359|Drug|Placebo|Tablets, oral, 0 mg, BID for 14 days
15724946|NCT05065346|Device|Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT|An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.
15724947|NCT05065333|Other|Septic Shock Clinical Decision Support|The intervention will be activating a septic shock clinical decision support tool (CDS) in the Electronic Health Record at the site, making it available to trigger and alert Emergency Department providers during clinical care. Patients will be identified when providers suspect sepsis and initiate a sepsis evaluation, using the institutional, clinically-standard, sepsis pathway/orderset. After the CDS is triggered, it will use available Electronic Health Record data to calculate the risk of septic shock, using previously-published predictive models [Ref 1, 2]. The CDS will notify providers if the patient is at elevated risk of septic shock and prompt them to follow institutional standard care for septic shock (including close monitoring, complete laboratory evaluation for organ dysfunction, and immediate clinical involvement of an attending Pediatric Emergency Physician). All clinical care decisions will be determined by the providers.
15724948|NCT05065333|Other|Clinical Diagnosis Only|Emergency Department sites in this arm will not have Clinical Decision Support for septic shock visible in the Electronic Health Record for providers at the site. Providers will follow usual institutional standards of sepsis care.
15724949|NCT05065307|Diagnostic Test|Venipuncture|Diagnostic venipuncture
15724950|NCT05065294|Drug|Psilocybin therapy|- Psilocybin administration session 10mg-25mg delivered orally with psychological support and monitoring
15724951|NCT05065281|Other|Education|Training for health care professionals on how to identify and manage cases of elder abuse among their patients
15724953|NCT05065255|Device|SpeediCath® catheters|Patients using SC catheters will be followed up in order to understand the major criteria in the choice of the catheter by the patients.
15724955|NCT05065229|Device|Oxygen saturation probe Mindray 520 N and Mindray 521 N|"Two oxygen saturation probes will be used in this study:
~Mindray 520 N is a disposable oxygen saturation sensor for neonates and adults. It is a disposable, single-use sensor that is wrapped around the infant's arm or foot. Its ends stick together giving a firm, close contact with the skin.
~Mindray 521 N is another disposable oxygen saturation sensor for neonates and adults that is used on the neonatal unit in routine practice. As Mindray 520 N and 521 N are CE marked and used within their intended purposes we do not require a letter of no objection from the MHRA for that usage. The Mindray probes will be used without modification and there are no safety issues to the patient. Therefore, a letter of no objection from the MHRA is not required and this is not a medical device study under the Medical Devices Directive."
15724957|NCT05065203|Procedure|planned or unplanned Cesarean, operative, or non operative delivery|All types of delivery
15724958|NCT05065190|Drug|nintedanib|nintedanib
15724959|NCT05065190|Drug|Placebo|Placebo
15724960|NCT05065177|Biological|Investigational live attenuated mumps vaccine|The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
15724961|NCT05065177|Biological|control live attenuated mumps vaccine|The control vaccine was manufactured by Zhejiang VACN bio-pharmaceutical Co. Ltd.
15724962|NCT05065164|Drug|Denosumab|denosumab subcutaneous injection /6 months, twice a year
15724963|NCT05065151|Other|Stimulation on|Stimulation from Percept PC DBS will be on while the patient is playing a decision-making game on a computer-based application.
15724964|NCT05065151|Other|Stimulation off|Stimulation from Percept PC DBS will be off while the patient is playing a decision-making game on a computer-based application.
15724965|NCT05065151|Behavioral|Decision Making Task|Patients will be playing a decision making task through a computer-based application.
15724966|NCT05065138|Behavioral|Standardized training on Helicobacter pylori eradication treatment|Standardized training on Helicobacter pylori eradication treatment
15724968|NCT05065112|Procedure|Pulmonary veins isolation + Cartofinder-guided ablation|The individualised mapping with Cartofinder intends to identify areas with the repetitive atrial activation patterns which are targeted with focal or linear ablation anchored on at least one end in an anatomical or electrical barrier.
15724969|NCT05065112|Procedure|Pulmonary veins isolation|Wide area circumferential pulmonary veins isolation
15724970|NCT05065099|Device|Online Treatment Recovery Assistance for Concussion in Kids (OnTRACK)|Patients and families will be provided the smartphone app on their personal mobile phone (Android, iPhone) or provided with a phone if they do not own one. The patients will view educational videos on concussion management, input their daily exertional status and weekly symptom status upon receiving pre-programmed notification prompts on their phone. Healthcare Providers will monitor symptom recovery via an HCP dashboard and make management recommendations using evidence-based algorithms regarding symptom recovery status. School personnel will monitor progress via a dashboard and provide targeted supports, they may also view educational videos on concussion management. Opportunities for communication between the HCP, parent/patient and school will be provided by the app.
15724973|NCT05065060|Other|Observation|Observation
15724974|NCT05065047|Drug|Belantamab mafodotin|Given by IV
15724975|NCT05065021|Drug|Niraparib|Niraparib works by blocking poly(ADP-ribose) polymerases (PARP) 1 and PARP 2 from working. PARP 1 and PARP 2 are proteins that are involved in cell growth, cell survival, and cell death, including cancer cells. It is believed that blocking PARP1 and PARP 2 from working will slow or stop the growth of cancer cells.
15724976|NCT05065021|Drug|Dostarlimab|Dostarlimab is a monoclonal antibody. Antibodies are proteins that are naturally found in the blood stream that fight infections. A monoclonal antibody is a special kind of antibody that is created in a laboratory that seeks out specific proteins in the body that may be involved in cancers to stop tumor growth. Dostarlimab attaches to PD-1 and inhibits the interaction of PD-L1 and PD-L2 with PD-1.
15724977|NCT05065021|Drug|Bevacizumab|Bevacizumab is a chemotherapy drug commonly used for the treatment of various cancers.
15724978|NCT05065021|Drug|Paclitaxel|Paclitaxel is a chemotherapy drug commonly used for the treatment of various cancers.
15724981|NCT05064969|Behavioral|Blended intervention based in acceptance and commitment therapy|"Blended intervention includes completing 9 e-modules consist of written material, videos, and assignments (one e-module per week) that can be completed over 9 to 12 weeks AND 9 (to 12 ) coaching sessions (telephone call). Weekly coaching will be offered by a motivational coach based in Maastricht University.
~After the post-intervention assessments, individuals will receive monthly calls from the motivational coach as booster sessions. Booster sessions will be received on monthly basis for a period of 6 months (one session per month) and until the last follow-up assessment. Communication with participants will take place online or via telephone."
15724982|NCT05064956|Biological|Ad26.ZEBOV|"Ad26.ZEBOV is a non-replicating, monovalent vaccine expressing the full-length Mayinga glycoprotein (GP) of the Ebola virus (formerly known as Zaire ebolavirus), and is produced in human cell line.
~Participants will receive a 0.5mL intramuscular injection of Ad26.ZEBOV, at a concentration of 1x10^11 vp/mL, into the anterolateral deltoid muscle."
15725009|NCT05064709|Device|Cardiac Contractility Modulation Therapy via OPTIMIZER™ Smart Mini System|Cardiac contractility modulation therapy, also known as CCM™, is a device-based therapy that may be an effective treatment modality for HF patients with a higher EF. In this study, CCM therapy will be delivered via the OPTIMIZER™ Smart Mini System. The Optimizer will be programmed to deliver 7 phases of CCM therapy per day that are distributed equally over a given 24-hour period.
15724983|NCT05064943|Diagnostic Test|2-minute step test|"The participant stands and counts for 2 minutes. The minimum height to raise the knee is determined for each participant by calculating the midpoint between the patella and the anterior superior iliac spine. They are instructed to complete as many steps as possible during the 2-minute period. A verbal command is given every 30 seconds to encourage performance: You're doing great, keep it up. If the claudication symptom becomes unbearable, the patient can stop during the test, but the time is not stopped. Patients who discontinue testing due to symptoms of claudication are encouraged to return to testing as soon as possible. An evaluator records the number of steps in the right leg."
15724984|NCT05064930|Dietary Supplement|Probiotic Bifidobacterium lactis|The probiotic will be administered orally over a period of 12 weeks.
15724985|NCT05064930|Dietary Supplement|Probiotic Bacillus coagulans|The probiotic will be administered orally over a period of 12 weeks.
15724986|NCT05064930|Dietary Supplement|Placebo|Maltodextrin as a placebo will be administered orally over a period of 12 weeks. The taste and appearance of the placebo will be similar to those of the probiotic formulation.
15724987|NCT05064917|Diagnostic Test|Blood draw|The burden for child/parents in this study is low as it is limited to a single blood draw, which is already necessary for usual diagnostic care in about 70% of the children
15724988|NCT05064904|Drug|never received RAAS blockers or received RAAS blockers before AKI.|"Enrollees who are not received renin-angiotensin-aldosterone blockers (RAAS) are randomly assigned to slow kidney function progression by adding RAAS blockers by receiving at least defined daily dose equal to Losartan 50mg or Captopril 25mg bid. The acute kidney disease (AKD) consultation should be transferred at least one time within 90 days after index hospital discharge after withdrawing from dialysis requiring AKI (AKI-D).
~All enrolled patients are randomly referred to receive comprehensive multidiscipline consultation targeting a glycated hemoglobin level of less than 7.0%, systolic blood-pressure, target, <130 mm Hg, low density lipid (LDL) less than 100mg/dL and control of hyperuricemia less than 7.2mg/deal in male as well as 6.1mg/dl in females. We suggest to adherence to low protein diet achieve the goal of hemoglobin more than 11g/L at 180 day after index discharge."
15724989|NCT05064891|Procedure|Ultrasound guided injection|Subdeltoid bursa injection, suprascapular nerve block, or posterior glenohumeral joint injection. The participants should only receive one type of the injection mentioned above.
15724992|NCT05064865|Dietary Supplement|Freeze-dried table grape powder|Consumption of 46g/day freeze-dried table grape powder
15724993|NCT05064865|Dietary Supplement|Placebo of the table grape powder|Consumption of 46g/day placebo version of the freeze-dried table grape powder
15724994|NCT05064852|Drug|Surufatinib|The study is a real-world study. According to the actual medical history of patients, the usage of Surufatinib was collected.
15724995|NCT05064839|Procedure|Bony scintigraphy|Bony scintigraphy (99mTc-Hydromethylene diphosphonate) will be performed in all patients with hypertrophy of the left ventricle
15724996|NCT05064826|Other|Observation|"Emergency Department Observation Units (EDOU) would allow the highest risk patients - those presenting for nonfatal overdose - to receive their first dose of BUP before leaving the ED.
~Operationally defined to include placement in an observation unit and/or placement under observation status with care provided by Emergency Medicine and/or other services (e.g., Internal medicine, Psychiatry)"
15724997|NCT05064813|Behavioral|Mindfulness Based Stress Reduction MBSR Intervention|MBSR is an 8-week group-based course developed by Jon Kabat-Zinn (1990) and colleagues at the University of Massachusetts' Center for Mindfulness. Weekly 2.5 hour long classes are given once a week, as well as one day-long weekend class. The classes instruct participants in the theory and practice of several forms of mindfulness meditation, breathing awareness, and mindfulness stretching exercises. Teaching of the theory of mindfulness and experiential practice are both utilized during weekly classes and at-home CD-guided practice sessions.
15724998|NCT05064813|Behavioral|Stress Education Control Condition (SE)|Stress Education (SE) was designed to provide an active comparator condition that does not include overlapping active components of mindfulness meditation with MBSR. It will also be delivered over 8-weekly, in-person, 2.5 hour group sessions of the same size (n=4 to 6). In SE, participants receive extensive information about stress and health, but will not receive any MBSR or other mind-body training. Instead, stress relevant psycho-educational information will be taught.
15725002|NCT05064787|Behavioral|Digital Health Coaching|The digital health coaching program consists of weekly calls and delivery of evidence-based content across health and wellness domains (e.g. nutrition, exercise, physical, emotional and financial health) up to 4 times weekly via text, email or mobile application. The program is 6-months in duration and designed for engagement following CAR T cell infusion.
15725005|NCT05064761|Device|Sculptra new dilution|Treatment to improve appearance of cellulite.
15725006|NCT05064748|Drug|Benvitimod|Benvitimod cream, 1%, applied twice daily for 12 weeks after enrolment.
15725010|NCT05064709|Device|Sham Therapy|No CCM therapy given after implantation of OPTIMIZER™ Smart Mini System for the first 18 months. CCM will be turned on following completion of the 18-month visit.
15725013|NCT05064683|Other|white noise|Newborns in the control group did not receive any treatment other than routine applications while receiving nasal CPAP support in the neonatal intensive care unit.The newborns in the faciliated tucking group were given supine, prone, and lateral positions for 24 hours, depending on their clinical status.The newborns in the white noise group were listened to white noise for 24 hours using an Mp3 player and a decibel measuring device to measure the sound level.
15725014|NCT05064670|Behavioral|Exercise|A 3 month supervised exercise program of resistance training (3 sets of 10-12 repetitions) using body weight and a resistance band, and moderate to high intensity aerobic activities (14-18 on the Borg scale) using callisthenic type activities. Classes are conducted live in groups through zoom. Participants will also receive exercise counselling sessions, supportive phone calls in the 3 month followup phase after the 3 month supervised exercise program.
15725016|NCT05064644|Other|Product that contains plant stanol ester|Product with active ingredient
15725017|NCT05064644|Other|Placebo product|Product without active ingredient
15725018|NCT05064631|Drug|Bacterial Lysate|Bacterial lysate medicines are made from bacterial cells that are broken down and are intended to stimulate the immune system.
15725019|NCT05064618|Drug|Am80|medicine taken internally
15725020|NCT05064579|Other|Questionnaires|Questionnaire in two parts: one part on the objectives related to taking the treatment and the objectives related to the treatment modality and a second part on the general characteristics of each participant and the characteristics of the child's asthma.
15725021|NCT05064566|Device|caries assessment|clinical visual examination (ICDAS II), digital io radiography, near infrared light transillumination (NIR-LT), and laser fluorescence (LF), and micro-CT images.
15725022|NCT05064553|Device|Study CT/MRI Imaging|Subjects with negative ultrasound will be sent for a study CT/MRI.
15725023|NCT05064553|Device|Standard of Care CT/MRI Imaging|Subjects with positive ultrasound are anticipated to have standard of care imaging follow-up as well as other procedures as needed.
15725024|NCT05064553|Diagnostic Test|Oncoguard Liver Test|Subjects will have a blood sample collected for the Oncoguard Liver Test.
15725025|NCT05064540|Device|Alto Abdominal Stent Graft System|Endovascular Abdominal Aneurysm Repair (EVAR) using commercially available, FDA approved endovascular graft systems implanted.
15725026|NCT05064540|Device|FDA Approved EVAR AAA Graft Systems|FDA approved comparator of choice
15725027|NCT05064527|Device|wearable biosensor|The E4 wristband will be worn by all groups for the duration of the study. It measures blood volume pulse, electrodermal activity, skin temperature, and movement. Patients will be asked to press the event tagging button when they feel stressed by OCD. Control will be asked to press the button when they feel anxious. Parents will be asked to press the button with they notice their child feels stressed by OCD or anxious.
15725028|NCT05064527|Device|App|The will be used for ecological momentary assessment (EMA) to assess child and caregiver emotion/arousal state at random times during the day for labelling biosensor data. It also contains forms for recording OCD symptoms on a weekly basis and a guided exposure and response prevention form.
15725029|NCT05064527|Behavioral|Treatment as usual (TAU)|Patients will receive treatment as usual at the child and adolescent mental health center. TAU can range from one session of psychoeducation to group psychotherapy, individual psychotherapy to medication.
15725030|NCT05064527|Behavioral|Exposure and response prevention (ERP)|One ERP session will be offered in Week 0 and Week 8.
15725031|NCT05064514|Device|Transcatheter Tricuspid Valved Stent Graft|All participants meeting the inclusion and none of the exclusion criteria will be enrolled. A custom-made Transcatheter Tricuspid Valved Stent Graft based on CT to define anatomic dimensions will be made. The system consists of a custom-made valved stent graft delivery system, a custom-made valved stent graft bioprosthesis and a loading system. The bioprosthesis is self-expanding and consists of a stent graft spanning from the inferior vena cava to the superior vena cava and a lateral bicuspid valve element made of thin porcine pericardial leaflets requiring a low closing pressure, and Nitinol support structures. The participants will undergo a minimally invasive, catheter-based procedure to implant the bioprosthesis which is delivered through a 24 French delivery system via transfemoral access. The device can be repositioned and is retrievable.
15725032|NCT05064501|Diagnostic Test|spirometry|Lung function test: pre and post bronchodilator spirometry
15725033|NCT05064501|Other|Asthma control test|Asthma control test
15725034|NCT05064488|Drug|Evobrutinib|Participants will receive evobrutinib film-coated tablet, twice daily under fed conditions from Days 4 to 12 in Part 1 and from Days 2 to 8 in Part 2 of the study.
15725035|NCT05064488|Drug|Digoxin|Participants will receive digoxin tablet under fed conditions, once a day on Day 1 and Day 10 in Part 1.
15725036|NCT05064488|Drug|Metformin|Participants will receive metformin oral solution under fed conditions, once a day on Day 1 and Day 10 in Part 1.
15725037|NCT05064488|Drug|Rosuvastatin|Participants will receive rosuvastatin tablet under fed conditions, once a day on Day 1 and Day 10 in Part 1.
15725038|NCT05064488|Drug|Sumatriptan|Participants will receive sumatriptan tablet under fed conditions, once a day on Day 1 and Day 8 in Part 2.
15725039|NCT05064475|Diagnostic Test|PET/CT|Patients with previous breast cancer, already treated and with clinical or biochemical suspicion of disease relapse. All patients will underwent 18F-fluorodeoxyglucose (FDG) PET/CT. In all patients, the value of CA 15.3 was compared to PET/CT. The final diagnosis of relapse will be derived from histopathological sampling As much as possible or radiological follow up for at least 6 months will be compared with PET/CT results.
15725040|NCT05064462|Other|Collection of EDTA blood sample (5 to 7 ml)|"For all the patients included in the study, the samples to measure the viral load will be taken during the transplantation, then at each of the consultations planned as part of the usual care during the first year post-transplant (at minimum once and maximum twice a month).
~These samples will be taken at the same time as those taken as part of standard care."
15725044|NCT05064436|Drug|11C-BMS-986196|Specified dose on specified days
15725097|NCT05063968|Drug|XZP-6019 tablet|Tablet is administered after a high-fat meal orally once on Day 9
15725045|NCT05064423|Behavioral|Clinical Trials Education Program|The Community Health Educator (CHE) will provide CT education and outreach to increase clinical trial knowledge and the importance of clinical trials research and participation. The clinical trials educational activities will include the use of NCI Colorectal Cancer resources and materials, including a PowerPoint presentation, clinical trials information, and online resources. The CHE will tailor the PowerPoint slides to ensure that they are culturally tailored, visually appealing, low-literacy, language appropriate and include appropriate visuals. The CTs educational sessions will be delivered in Spanish and English and will take approximately 45 minutes to 1 hour.
15725046|NCT05064410|Behavioral|Educational Intervention|The colorectal cancer (CRC) educational activities will include the use of NCI CRC resources and materials, including a PowerPoint presentation, and CRC educational models and displays. The CRC education will be delivered in Spanish and English, and will consist of pre and post knowledge assessments including screening and behavioral intention questions. The educational intervention will take approximately 45 minutes-1 hour.
15725049|NCT05064358|Drug|Belantamab mafodotin|Belantamab mafodotin will be administered.
15725050|NCT05064345|Drug|HB0034|Recombinant Humanized Anti-IL-36R Monoclonal antibody
15725051|NCT05064345|Drug|Placebo|Palcebo
15725052|NCT05064332|Drug|PF-06650833|400 mg by mouth (PO) Once daily (QD) for 11 days
15725053|NCT05064332|Drug|Ethinyl estradiol (EE) and levonogestrel (LN)|Single dose of Oral tablet containing 30 ug EE and 150 ug of LN
15725056|NCT05064306|Drug|131I-omburtamab|50 mCi 131I-omburtamab
15725057|NCT05064293|Behavioral|Navigation Arm|Families will be offered a formal assessment to ascertain the primary mental health diagnosis and any co-occurring mental health disorders. After completing the online parent/guardian self-assessment, parents/guardians will meet with a mental health clinician to review their answers, discuss diagnoses, and refer the family back to the navigator for connection to care or study-provided tele-video visits. Navigators will outreach families monthly during the 6-month study period. The navigator will inquire about the child's status and re-evaluate barriers to access. When barriers exist, the navigator will help in facilitating specialty treatment initiation and assess appropriateness of tele-video therapy sessions until ongoing MH services can be arranged. Families/patients reporting that index symptoms have resolved will be offered a 'watchful waiting' approach. Subjects accepting 'watchful waiting' will be outreached quarterly, but not beyond the end of the 6-month follow-up period.
15725058|NCT05064293|Behavioral|Control Arm|Families who agree to participate will first be offered a formal assessment in order to ascertain the primary mental health diagnosis and any co-occurring mental health disorders (e.g., substance use). After completing the online parent/guardian self-assessment, parents/guardians will meet for 30 minutes with a mental health clinician to review their answers, discuss diagnoses, and refer the family back to their primary care provider. Control arm participants do not receive navigation.
15725059|NCT05064280|Drug|pembrolizumab|Given by IV
15725060|NCT05064280|Drug|Lenvatinib|Given by PO
15725061|NCT05064267|Diagnostic Test|phlebotomy|phlebotomy will be performed to obtain coagulation labs of interest. Specifically, in addition to standard clinical labs, the following will be drawn on study participants: thrombelastography with platelet mapping, antithrombin, DIC panel, factor VIII, vWF antigen, Protein C antigen and activity, Protein S antigen and activity, and ferritin.
15725062|NCT05064254|Other|Treatment as usual (TAU)|TAU may include self-help methods, physician visit, provision of resources etc.
15725063|NCT05064254|Other|Mindful Adaptive Practice in Pregnancy Therapy|MAP teaches: a) recognition of personal maladaptive/ distressing patterns driving anxiety; b) how to relate differently; and c) cultivation of more adaptive ways of dealing with anxiety and learning how to effectively control it rapidly which allows re-engagement with life in more flexible ways.
15725064|NCT05064241|Other|Access to Genetic Counselor for answering questions|A genetic counselor answers questions posed by participants in the intervention arm on how to access genetic medicine. At the end of the study, the number of participants who were able to access genetic medicine will be assessed
15725065|NCT05064228|Behavioral|Mobile Rewarding Activity Centered Treatment (m-ReACT)|Participants will utilize m-ReACT for 12-weeks, reporting daily on substance-free activity engagement and enjoyment (EMA). m-ReACT will utilize these EMA reports to generate brief, automated, and personalized feedback about enjoyed categories of substance-free activities as well as make suggestions for increasing engagement in those rewarding, goal-oriented substance-free activities, and provide personalized suggestions of activities of interest.
15725066|NCT05064215|Procedure|anatomical examination|After injection of dye, its distribution along lymphatic clearance paths was investigated
15725067|NCT05064202|Device|Impella CP|percutaneous Mechanical Circulatory Support (pMCS), percutaneous Left Ventricular Assist Device (pLVAD)
15725068|NCT05064202|Drug|Inotropes|Enoximone, Dobutamine, Dopamine, Milrinone
15725069|NCT05064189|Device|Lacrimera|A new preservative-free formulation of eye drops consists of a novel biopolymer, chitosan-N-acetylcysteine (C-NAC; Lacrimera®, Croma-Pharma GmbH, Leobendorf, Austria), which electrostatically binds to the mucine layer of the tear film forming a glycocalyx-like structure.
15725098|NCT05063968|Drug|XZP-6019 tablet|Tablet is administered orally once daily for 14 Days continuously
15725099|NCT05063968|Drug|Placebo|Tablet is administered orally once daily for 14 Days continuously
15725100|NCT05063929|Other|Fruit (2 cup eq)|participants will receive 2 cup eq fruits
15725101|NCT05063929|Other|Fruit restriction (1/2 cup eq)|participants will receive 1/2 cups eq fruits
15725102|NCT05063916|Drug|AK104|Given By IV
15725070|NCT05064176|Other|Usual care|"Home physical therapist performs usual care and educates the patient to perform self-management
~Usual care:
~M1-6: 6 months of maintenance decongestive lymphatic therapy (DLT) (by patient and home physical therapist):
~week 1-2: no physical therapy; patient performs limb elevation, muscle contractions and wears the bandage (intervention group)/ compression garment (control group)
~week 3-4: start physical therapy, 2 days/ week: exercises, skin care & manual lymph drainage (MLD), education; self-management by patient and wearing compression garment 14-16h/day (4 sessions) M2-6: 1 day/ week physical therapist: exercises, skin care & MLD, and self-management by patient and wearing compression garment 14-16h/day (20 sessions)
~M7-12: 6 months of maintenance DLT by patient (self-management) and home physical therapist:
~- 1 day/week physical therapist: skin care, MLD, exercises (26 sessions) Month 13-18: 6 months of maintenance DLT by patient Month 19-36: 18 months of follow-up"
15725071|NCT05064176|Procedure|Reconstructive lymphatic surgery|"For the procedure of LVA:
~- Aim: making anastomoses of lymph vessels at the capillary level with a diameter of 0.3 to 0.8 mm, to redirect lymph to venous stream directly
~For the procedure of LNT:
~- Aim:
~Placed lymph nodes act as sponge to absorb lymphatic fluid and direct it into the vascular network;
~Placed lymph nodes induce lymphangiogenesis"
15725072|NCT05064137|Drug|Monomeric self - assembling peptide P11-4|Monomeric self - assembling peptide P11-4 ( Curodont Repair ) is a remineralizing agent applied to tooth surface after treating it with 3% sodium hypochlorite for 20 seconds then etching it with 37% phosphoric acid for 20 seconds followed by rinsing then dryness.
15725073|NCT05064137|Drug|Tricalcium phosphate fluoride varnish, 5% F-|Tricalcium phosphate fluoride varnish, 5% F- ( Clinpro White Varnish ) is a remineralizing agent applied on tooth surface after mixing it with a brush onto the dosage guide.
15725074|NCT05064124|Device|CADDIE - Computer Aided Detection and Diagnosis for Intelligent Endoscopy|"CADDIE assisted polyp detection
~CADDIE assisted polyp characterisation"
15725075|NCT05064111|Diagnostic Test|TRUS biopsy|The biopsy procedure will be completed using an FDA-approved ultrasound machine with the addition of an investigational (non-FDA approved) image fusion software.
15725076|NCT05064085|Drug|Cemiplimab|Participants will be given Cemiplimab 350 mg IV day 1 every 21 days
15725077|NCT05064085|Drug|Capecitabine|Participants will take Capecitabine at 2 dose levels: 800 mg/m^2 and 1000 mg/m^2 by mouth twice daily 14 days on, 7 days off starting on day 3 every 21 days.
15725078|NCT05064072|Device|Water-based barrier tape|"The infants in experiment 1 group will be applied water-based barrier tape. The area will be covered by water-based barrier tape to fix nasogastric tube and after waiting 1 minute for drying up it will be fastened by silk tape used in clinic. The silk tape will be 5 cm long and it will be changed in every 24 hours. Following the removal of silk tape on the water-based barrier tape, the pain felt by the infants evaluated through Neonatal Infant Pain Scale and the score recorded in the chart. This procedure actualized 3 min. before procedure, during and 3 min after procedure."
15725079|NCT05064072|Device|Hydrocolloid barrier tape|"As for experiment 2 group, hydrocolloid barrier tape will be used to fix the nasogastric tube. The hydrocolloid barrier tape, which was cut and shaped appropriately beforehand, will be applied to the area in order to stabilize the nasogastric tube and the tube will be stabilized with silk tape used in clinic. The silk tape will be 5 cm long and it will be changed in every 24 hours. Following the removal of silk tape on the hydrocolloid barrier tape, the pain felt by the infants evaluated with Neonatal Infant Pain Scale and the score recorded in the chart. Since the hydrocolloid barrier tape can stay on the skin for 7 days and the assessment of the pain realized in 7th day and noted down to the chart. Pain score evaluated in 7th day 3 min. before procedure, during and 3 min after procedure"
15725080|NCT05064072|Device|Silk tape|"The silk tape used in clinic routinely will be used for control group infants to fix the nasogastric tube without any barrier. The silk tape will be 5cm long and it will be changed in every 24 hours. Following the removal of silk tape on the silk tape, the pain felt by the infants evaluated through Neonatal Infant Pain Scale and the score recorded in the chart. This procedure actualized 3 min. before procedure, during and 3 min after procedure"
15725081|NCT05064059|Biological|favezelimab/pembrolizumab|Coformulated favezelimab/pembrolizumab (800 mg/200 mg), IV infusion
15725082|NCT05064059|Drug|regorafenib|Oral
15725083|NCT05064059|Drug|TAS-102|Oral
15725084|NCT05064046|Behavioral|LuCa + Health Disparity module|"The Health Disparity course will review disparities in the burden of lung cancer across racial/ethnic groups, discuss differences in smoking patterns and use of evidence-based smoking cessation, and describe emerging disparities in lung cancer screening. The course will also offer resources for providers to address common barriers to screening among underserved/underrepresented groups, including insurance information, transportation options, procedure time, and patient navigation assistance.
~Lesson 1 of the LuCa online course addresses lung cancer screening and shared decision making."
15725085|NCT05064033|Other|Pragmatic Set of intervention and posterior capsular stretch|Group 1 will receive a pragmatic set of interventions, including Serratus Anterior Stretch,Rotator Cuff Facilitation,Acromilcalavicular joint Mobilization,Stretch of Pectoralis Major and Minor,Thoracic Manipulation and posterior capsular stretch.
15725086|NCT05064033|Other|Pragmatic Set of intervention and Sleeper Stretch|Group 2 will receive a pragmatic set of interventions, including Serratus Anterior Stretch, Rotator Cuff Facilitation, Acromilcalavicular joint Mobilization, Stretch of Pectoralis Major and Minor, Thoracic Manipulation and sleeper stretch.
15725087|NCT05064020|Drug|Bictegravir/Emtricitabine/Tenofovir Alafenamide 50 MG-200 MG-25 MG Oral Tablet [BIKTARVY]|Administer BIC/FTC/TAF 50/200/25 mg tablet by mouth once a day from day 1 to168.
15725088|NCT05064007|Behavioral|A: 40 Hz music|The participant will listen to the 40 Hz music playlist one hour each day, 5 days a week for 4 weeks
15725089|NCT05064007|Behavioral|B: 40 Hz sound|The participant will listen to the 40 Hz sound playlist one hour each day, 5 days a week for 4 weeks
15725090|NCT05064007|Behavioral|C: Preferred music|The participant will listen to the preferred music playlist one hour each day, 5 days a week for 4 weeks
15725091|NCT05063994|Drug|Chronocort|Over-encapsulated hydrocortisone modified-release capsules for oral administration - 5mg and 10mg
15725092|NCT05063994|Drug|Cortef|Over-encapsulated immediate-release hydrocortisone capsules for oral administration - 5mg and 20mg
15725093|NCT05063981|Drug|Mepolizumab|Treatment with Mepolizumab could modify nasal, bronchial and systemic inflammation of patients with severe refractory eosinophilic asthma and nasal polyposis acting on disease control
15725406|NCT05061524|Drug|YH35324|Subcutaneous injection of YH35324
15725103|NCT05063903|Other|Demographic and clinical characteristics, incremental shuttle walk test, six minute walk test, hand grip strength, M. Quadriceps isometric muscle strength, body composition|"Demographic and clinical characteristics Age and complaints, post-operative follow-up, other problems, medications, ECHO and ECG findings, laboratory tests (complete blood count, liver and kidney function tests, brain natriuretic peptide (BNP) level)
~Hand grip strength Right and left hand grip strength the highest of the three measurements
~Lower extremity muscle strength Maximum isometric muscle strength of the quadriceps femoris
~Body composition Body fat ratio, lean body weight and fat weight by bioelectrical impedance analysis
~6 minute walk test The six minute walk test distance recorded in meters
~Incremental shuttle walk test The lap number, the number of laps of the last level they can reach, and the walking/running distances recorded in meters"
15725104|NCT05063890|Procedure|Muscle Specific Post Isometric Relaxation MET|3-5 reps of Post Isometric Relaxation MET targeted at muscles of the neck prone to get short
15725105|NCT05063890|Procedure|Movement Specific Post Isometric Relaxation MET|3-5 reps of Post Isometric Relaxation MET targeted at specific movements of the cervical spine
15725106|NCT05063890|Procedure|unilateral postero-anterior glide|3 sets of unilateral posteroanterior glide (10-15 oscillations) at the involved segment
15725107|NCT05063890|Procedure|Heating and TENS|Heating and TENS for 10 minutes
15725108|NCT05063877|Drug|Placebo|Matched placebo
15725109|NCT05063877|Drug|EQU-001|EQU-001 in 10 mg and 20 mg capsules
15725110|NCT05063864|Other|Nursing Support Program|"Within the scope of the nursing support program, counselling services were provided to women by making regular phone calls that lasted 15-20 minutes once a week. Within the scope of the support program, two training booklets titled Life After Hysterectomy Surgery and Women's Health During Menopause were prepared by reviewing the literature."
15725111|NCT05063851|Drug|Memantine Hydrochloride Tablets|The recommended starting dose of memantine hydrochloride/placebo is 5 mg once daily. The dose should be increased in 5 mg increments to 10 mg/day (5 mg twice daily), 15 mg/day (5 mg and 10 mg as separate doses), and 20 mg/day (10 mg twice daily). The minimum recommended interval between dose increases is one week. The dosage shown to be effective in controlled clinical trials is 20 mg/day.
15725112|NCT05063851|Drug|Placebo|The recommended starting dose of memantine hydrochloride/placebo is 5 mg once daily. The dose should be increased in 5 mg increments to 10 mg/day (5 mg twice daily), 15 mg/day (5 mg and 10 mg as separate doses), and 20 mg/day (10 mg twice daily). The minimum recommended interval between dose increases is one week. The dosage shown to be effective in controlled clinical trials is 20 mg/day.
15725113|NCT05063838|Other|Pharmacogenomic optimisation of anaesthetic medications|Personalisation of anaesthetic plan based on pharmacogenomic results and international guidelines.
15725114|NCT05063825|Behavioral|Simple cognitive task intervention|"A memory cue followed by playing the computer game Tetris (on own smartphone) with mental rotation instructions for ca. 12 minutes."
15725115|NCT05063825|Behavioral|Attention placebo|A memory cue followed by listening to a podcast (on own smartphone) for ca. 12 minutes.
15725116|NCT05063812|Other|Observational|All these patients have been enrolled in the COVID-19 remote patient monitoring program
15725117|NCT05063799|Other|pulmonary rehabilitation|pulmonary rehabilitation programs
15725118|NCT05063786|Biological|Trastuzumab|8 mg/kg IV loading dose, followed by 6 mg/kg IV every 3 weeks (3-weekly schedule), or 4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly (weekly schedule), or 600 mg SC every 3 weeks.
15725119|NCT05063786|Drug|Alpelisib|300 mg oral once daily.
15725120|NCT05063786|Drug|Fulvestrant|500 mg intramuscular every 4 weeks plus loading dose on day 15 cycle 1.
15725121|NCT05063786|Drug|Vinorelbine|Oral (60 mg/m2) or IV (25 or 30 mg/m2 per investigator preference) on days 1 and 8, every 3 weeks.
15725122|NCT05063786|Drug|Capecitabine|1250 or 1000 mg/m2 (per investigator preference) twice a day (BID) oral, 2 weeks on, 1 week off, every 3 weeks.
15725123|NCT05063786|Drug|Eribulin|1.23 mg/m2 IV on days 1 and 8, every 3 weeks.
15725124|NCT05063773|Device|Mixed reality heads up display|Physician will use a mixed reality headset for image guidance of the procedure
15725125|NCT05063760|Behavioral|aerobic-strength exercise intervention (6-months)|6 month supervised exercise intervention in TGCT survivors (1 hour sessions 3 x per week),
15725126|NCT05063747|Other|No intervention.|Observational study. No intervention.
15725127|NCT05063734|Drug|THR-687 dose level 1|3 intravitreal injections of THR-687 dose level 1, 1 month apart
15725128|NCT05063734|Drug|THR-687 dose level 2|3 intravitreal injections of THR-687 dose level 2, 1 month apart
15725129|NCT05063734|Drug|THR-687 selected dose level|3 intravitreal injections of THR-687 selected dose level, 1 month apart, possibly followed by a 4th intravitreal injection with the same dose level of THR-687 at Month 3, or Month 4, or Month 5, if any of the PRN criteria are met.
15725130|NCT05063734|Drug|Aflibercept|3 intravitreal injections of aflibercept, 1 month apart, possibly followed by a 4th intravitreal injection with aflibercept at Month 3, or Month 4, or Month 5, if any of the PRN criteria are met.
15725131|NCT05063721|Biological|autologous mesoangioblasts|intra-arterial administration of autologous mesoangioblasts in lower leg (50x10E6/kg)
15725132|NCT05063708|Device|Experimental: traditional dysphagia therapy plus Neuromuscular electrostimulation|In the present study, VitalStim equipment will be used (VitalStim Therapy; Chattanooga Group, Chattanooga, TN, USA). Therapists received additional training and information on NMES by an experienced laryngologist certified to use surface electrical stimulation.
15725133|NCT05063708|Device|Sham Comparator: Traditional dysphagia therapy plus sham Neuromuscular electrostimulation|Therapists received additional training and information on NMES by an experienced laryngologist certified to use surface electrical stimulation. The training was given according to the manual of the manufacturer, the VitalStim certification course (http://www.vitalstim.com).
15725134|NCT05063695|Other|Multimodal Erector spinae catheter protocol|Patients either received multimodal epidural or ESP protocol
15725135|NCT05063682|Biological|EGFRvIII-specific hinge-optimized CD3 ζ-stimulatory/41BB-co-stimulatory Chimeric Antigen Receptor autologous T-lymphocytes|ICV administration
15725407|NCT05061524|Drug|Placebo|Subcutaneous injection of None of active ingredient
15725408|NCT05061524|Drug|Omalizumab|Subcutaneous injection of Omalizumab
15725673|NCT05059210|Behavioral|Coach McLungs Intervention|Practices have received implementation of Coach McLungs
15725136|NCT05063669|Behavioral|Cognitive Occupational Therapy|In the sessions, activities aimed at reasoning and empathy skills, problem solving, evaluating emotional cues, evaluating events from different perspectives, providing personal control, delaying reactions, motor planning, visual perception and prolonging attention span were applied. The interventions were varied according to the personal characteristics of the individuals. In group interventions with three or four participants, group games in the form of cooperation or competition were planned to develop motor planning and cognitive strategy and it was aimed to improve children's rapid decision making and adaptation skills.
15725137|NCT05063656|Drug|Gabapentin|8 weeks of gabapentin, titrated up to 20 mg/kg in 3 divided doses daily
15725138|NCT05063643|Other|High altitude|High altitude is defined as >2000m.
15725139|NCT05063630|Procedure|Medical treatment plus intracranial stenting|This group will be both given medical treatment (aspirin 100 mg and clopidogrel 75 mg per day for 90 consecutive days and clopidogrel 75 mg per day thereafter) and performed with intracranial stenting.
15725140|NCT05063630|Drug|Medical treatment alone|This group will be given medical treatment including aspirin 100 mg and clopidogrel 75 mg per day for 90 consecutive days and clopidogrel 75 mg per day thereafter.
15725142|NCT05063604|Drug|Citalopram|20 mg tablet one or twice daily for 12 weeks
15725143|NCT05063604|Behavioral|Psychotherapy|One session weekly for 12 weeks
15725144|NCT05063591|Other|Transfusion support|Patients will be offered symptom-driven transfusion support in addition to standard hospice care
15725145|NCT05063578|Drug|Lidocaine 2% Injectable Solution|Different concentration of lidocaine, injected via axillary block for arterio-venous fistula creation surgery
15725146|NCT05063565|Device|TheraSphere Y-90 glass microsphere therapy|TheraSphere Y-90 glass microsphere therapy administered through the hepatic artery at index procedure.
15725147|NCT05063565|Drug|Durvalumab (Imfinzi) immunotherapy|1500 mg, every 4 weeks that continues for a maximum duration of 18 months or until confirmed progression.
15725148|NCT05063565|Drug|Tremelimumab immunotherapy|300 mg, single administration
15725149|NCT05063552|Biological|Atezolizumab|Given IV
15725150|NCT05063552|Biological|Bevacizumab|Given IV
15725151|NCT05063552|Drug|Carboplatin|Given IV
15725152|NCT05063552|Biological|Cetuximab|Given IV
15725153|NCT05063552|Drug|Cisplatin|Given IV
15725154|NCT05063552|Drug|Docetaxel|Given IV
15725158|NCT05063526|Device|ultrasound|ultrasound on diaphragm
15725159|NCT05063513|Biological|Autologous Hematopoietic Stem Cell Transplantation|Experimental arm will undergo mobilisation with CY 4 g/m2 (in two divided doses), followed by Autologous Hematopoietic Stem Cell Transplantation using CY (200 mg/kg body weight given in 4 daily doses) plus ATG and unmanipulated autologous graft and maintenance by Mycophenolate Mofetil (2 g/day) starting 3 months after randomization.
15725160|NCT05063513|Drug|Rituximab|Control arm will receive 4 successive weekly infusions of rituximab (antiCD20) 375 mg/m2 body surface area for four weeks and maintenance by Mycophenolate Mofetil (2 g/day) starting 3 months after randomization.
15725161|NCT05063500|Drug|bicyclol, 25mg/ tablet|Experimental group: each oral bicyclol 50mg, three times daily for 4 weeks.
15725162|NCT05063500|Drug|polyene phosphatidylcholine capsules, 228mg/ particle.|Control group: each oral polyene phosphatidylcholine 456mg, three times daily for 4 weeks.
15725163|NCT05063487|Other|Return of recent classification|As part of routine HIV case-based surveillance in Rwanda, blood samples are collected for recency testing on the Rapid Test for Recent Infection (RTRI) assay and viral load testing for all newly diagnosed people living with HIV. Results of a recent classification (i.e., having acquired an HIV infection within the last year) will be returned to study participants during a scheduled 1-month visit following initial HIV diagnosis.
15725164|NCT05063487|Other|Return of long-term classification|As part of routine HIV case-based surveillance in Rwanda, blood samples are collected for recency testing on the Rapid Test for Recent Infection (RTRI) assay and viral load testing for all newly diagnosed people living with HIV. Results of a long-term classification (i.e., having acquired an HIV infection more than one year ago) will be returned to study participants during the scheduled 1-month visit following initial HIV diagnosis.
15725165|NCT05063474|Diagnostic Test|No Intervention-Clinical Assessments only|No Intervention. Clinical Assessments include: vital signs, near infrared spectrometry, general leg strength, and 6-minute walking test.
15725166|NCT05063461|Device|tetanic stimulation|Using a standard muscle relaxometer to generate tetanic stimulation
15725167|NCT05063448|Behavioral|DadSpace|A group educational support and mentoring program for perinatal fathers.
15725168|NCT05063435|Diagnostic Test|Carotid ultrasonography|"Study takes 10 - 15 minutes to complete
~Subject will be asked to lay still and quietly during procedure
~The ultrasound probe will be placed on one side of the neck to capture images of the carotid artery. When images from one side have been captured, the probe will be moved to the other side of the neck to capture images from the other carotid artery.
~Blood pressure and heart rate will be obtained during the study
~Results will be anonymized, digitized and stored on CD with unique identifier"
15725169|NCT05063435|Diagnostic Test|Echocardiography, transthoracic|"Study takes 15 - 20 minutes to complete
~Subject will be asked to lay still and quietly during procedure
~The technician will apply an ultrasound probe to the chest. Images and movies will be acquired.
~Results will be digitized and stored on CD"
15725196|NCT05063214|Diagnostic Test|Muscle ultrasound evaluation|Muscle ultrasound evaluation will be performed in patients admitted with COVID-19 requiring invasive mechanical ventilation. The measurements of thickness and thickening fraction will occur for diaphragm, abdominal - rectus abdominis, internal oblique, external oblique and transverse abdomen - and parasternal intercostal muscles. Serial measurements of the thickness and echogenicity of the quadriceps femoris muscle will also be performed.
15725170|NCT05063435|Procedure|Venipuncture|"10 mL of blood total will be drawn (5 mL in a blue top citrate tube, 5 mL in a purple top EDTA tube). Measurements of cytokines, clusterin, lipidomics, cathepsin S protease, and elastin (previously identified potential biomarker candidates) will be performed.
~Blood will preferably be drawn via venipuncture, but if patient has a port-a-cath already implanted and is having blood drawn via port-a-cath for clinically required reasons, then study-related blood draw via port-a-cath can take place concurrently with clinically required blood draws."
15725171|NCT05063422|Drug|polymyxin b/trimethoprim ophthalmic, Carboxymethyl cellulose|3 forms of denture adhesives from each brands are used to compare the retentive strength on highly resorbed ridges
15725172|NCT05063409|Other|Treatment|Blood product transfusion at a ratio of 1:1 FFP to PRBC or 1:4 FFP to PRBC during the operative period (start of surgery to 12 hours post operatively)
15725173|NCT05063396|Procedure|opioid free anesthesia|Instead of use of large amount of opioids for intraoperative stress response and postoperative pain controlling, during the whole perioperative period patients received no opioid at all. intravenous local anesthetics and thoracic epidural were used.
15725174|NCT05063396|Procedure|Opioid-sparing anesthesia|patients will receive opioid-sparing anesthesia protocol with minimal intraoperative sufentanil, remifentanil and epidural hydromorphone.
15725175|NCT05063383|Other|This study does not involve any interventions|This study does not involve any interventions
15725178|NCT05063357|Drug|131I-Omburtamab|Omburtamab is a murine IgG1 monoclonal antibody, recognizing CD276 (also known as B7-H3).
15725179|NCT05063357|Device|Convention Enhanced Delivery|The planned intervention includes surgical placement of a small caliber cannula into the tumor located in the pons using standard stereotactic techniques followed by CED of 131Iomburtamb.
15725180|NCT05063344|Device|Diagnostic Test: NOWDx Syphilis Test|For this observational trial, the Intervention of interest is the NOWDx Syphilis Test.
15725183|NCT05063318|Drug|Lurbinectedin alone|The dose of lurbinectedin during Parts A and B will be 3.2 mg/m² for all patients when administered without itraconazole.
15725184|NCT05063318|Drug|Lurbinectedin+Itraconazole co-administration|The dose of lurbinectedin when given in combination with itraconazole for the initial three patients in Part A will be 0.8 mg/m², and in Part B is susceptible to be adjusted properly if deemed necessary based on exposure and safety experience in Part A.
15725187|NCT05063292|Procedure|Patients in Group II will receive active prewarming with an air forced blanket (full body blanket) 30 minutes prior to the operation|Core temperature and 4-points skin temperatures measurements will be recorded all over the operation. Patients will be delivered 2 Litre/minute oxygen with a nasal cannula.Iv hydration will be continued by room temperatured balanced electrolyte solution with an infusion rate of 2mL/kg/hr. Spinal anesthesia will be applied at the level of L3-L4 by a 25 Gauge Quincke needle with a dose of 12.5-15 mg hyperbaric bupivacaine in the sitting position.
15725188|NCT05063279|Other|Progressive resistance training|Progressive resistance training, performed with a target number of repetitions of 10 per set. Sets are performed to exhaustion, and external load will be adjusted to meet the target number of repetitions.
15725189|NCT05063266|Other|Deep Breathing Exercise|control groups received deep breathing exercise 6 days a week for two weeks. Deep breathing exercises includes diaphragmatic breathing and pursed lip breathing.
15725190|NCT05063266|Other|Inspiratory muscle Training|Treatment group received inspiratory muscle training 20 minutes 6 days a week for two weeks.IMT was done by using pressure threshold device.
15725191|NCT05063253|Drug|TG103|TG103 injection, SC, once weekly
15725192|NCT05063253|Drug|Placebo|Placebo, SC, once weekly
15725193|NCT05063240|Behavioral|Mobile phone text messaging plus prospective motivational interviewing|Interactive weekly mobile phone text messaging plus prospective motivational interviewing at study follow up visits
15725194|NCT05063240|Behavioral|Standard infant feeding counselling|Standard infant feeding counselling as part of routine practice at primary healthcare facility
15725195|NCT05063227|Diagnostic Test|Observational: analgesia monitoring indices and changes in heart rate|After the end of surgery (defined as the time of skin closure or wound dressing), but before awakening (BIS will still be < 60), SPI, PPI and NOL are recorded in a quiet setting without any other stimulation. Within the five minutes data acquisition period nociception indices are recorded every minute (T0, T1, T2, T3, T4, T5). The highest SPI, PPI and NOL are used for further analysis.
15725328|NCT05062122|Other|observational intervention|To evaluate the effectiveness of the first different application by comparing it with the control group.
15725674|NCT05059197|Dietary Supplement|AP collagen peptide|Health functional food
15725197|NCT05063201|Drug|Cariprazine 1.5 MG|Subjects will attend two visits per week during the 8-week Outpatient Treatment Phase. Counseling services, in the form of Medication Management (MM) will be provided weekly. A urine sample for drug testing, vitals, AEs, and COWS will be collected/assessed at each visit. At the first weekly visit attended, concomitant medications, medication compliance, AIMS and a blood sample for later analysis of plasma levels of cariprazine and its metabolites will also be collected. The TLFB, C-SSRS, CSSA, SOWS, BSCS, DTS and a UPT (females only) will be collected once weekly. On the final appointment of week 8 only, a physical exam and ECG will be performed and standard laboratory measures (blood chemistry, CBC with differential, fasting glucose and lipids, serum prolactin, medical urinalysis) will be assessed. During week 8, additional assessments will be collected, including the ASI, HAM A/D and Treatment Opinion Form (TOF).
15725198|NCT05063201|Drug|Placebo|Subjects will attend two visits per week during the 8-week Outpatient Treatment Phase. Counseling services, in the form of Medication Management (MM) will be provided weekly. A urine sample for drug testing, vitals, AEs, and COWS will be collected/assessed at each visit. At the first weekly visit attended, concomitant medications, medication compliance, AIMS and a blood sample for later analysis of plasma levels of cariprazine and its metabolites will also be collected. The TLFB, C-SSRS, CSSA, SOWS, BSCS, DTS and a UPT (females only) will be collected once weekly. On the final appointment of week 8 only, a physical exam and ECG will be performed and standard laboratory measures (blood chemistry, CBC with differential, fasting glucose and lipids, serum prolactin, medical urinalysis) will be assessed. During week 8, additional assessments will be collected, including the ASI, HAM A/D and Treatment Opinion Form (TOF).
15725199|NCT05063188|Other|Connective Tissue Massage|Connective tissue massage was started from lumbosacral region and continued lower thoracic, scapular, interscapular, and cervical regions, respectively.
15725200|NCT05063188|Other|clinical pilates exercises|Exercises were applied 3 times for 6 weeks, a total of 18 sessions. One session consisted of 10 minutes of warm-up, 40 minutes of Clinical Pilates exercises and 10 minutes of cooling down (60 minutes in total).
15725201|NCT05063175|Other|Conventional Physical Therapy Protocol|The conventional physical therapy protocol was prescribed to correct the kyphotic posture of the dorsal spine, and improve postural balance stability during standing and walking. The conventional therapeutic protocol for every child was three sessions per week for 12 successive weeks. Every treatment session was applied for two hours with a few minutes rest in between them.
15725202|NCT05063175|Other|TheraTog orthotic undergarment with its strapping system|TheraTog orthotic undergarment with its strapping system was conducted for 8 hours daily for 12 successive weeks. It is made to be fitted directly on the skin as undergarments.
15725203|NCT05063162|Drug|Rozanolixizumab|"Pharmaceutical form: Solution for infusion
~Route of administration: subcutaneous infusion
~Participants will receive pre-specified doses of rozanolixizumab."
15725204|NCT05063162|Other|Placebo|"Pharmaceutical form: Solution for infusion
~Route of administration: subcutaneous infusion
~Participants will receive placebo."
15725205|NCT05063149|Drug|Broncho-Vaxom|Broncho-Vaxom is a bacterial extract comprising lyophilised fractions of 21 different inactivated bacterial strains, which are frequently causing RTI.
15725206|NCT05063149|Other|Placebo|Placebo powder from a capsule will be given, which will be indistinguishable from the active study drug.
15725207|NCT05063136|Drug|Capecitabine+endocrine therapy|Capecitabine (500mg, tid) (for 1 year)+ standard endocrine therapy (at least 5 years)
15725208|NCT05063136|Drug|Placebo+endocrine therapy|Placebo (tid) (for 1 year)+ standard endocrine therapy (at least 5 years)
15725209|NCT05063123|Drug|Flotetuzumab|Flotetuzumab will be given after at least 2 intensive chemotherapy cycles and before the start of the conditioning regimen prior to allo-HCT.
15725210|NCT05063110|Drug|Itacitinib|Administration of 300 mg of ITACITINIB per os every day for 30 days.
15725211|NCT05063097|Other|urine test|The following illicit drugs will be evaluated for all consecutive patients by urine drug assay (NarcoCheck®, Kappa City Biotech SAS, Montluçon, France) within two hours of admission to the ICCU: i) cannabinoids (tetrahydrocannabinol [THC]), including cannabis and hashish; ii) cocaine and metabolites, including cocaine and crack; iii) amphetamines; iv) MDMA; and v) heroin and other opioids. In addition to the analysis of psychoactive drug use, the investigators will also use the NarcoCheck® urine drug assay to evaluate the associated use of the following psychostimulant drugs: barbiturates, benzodiazepines, tricyclic antidepressant drugs, methadone and buprenorphine.
15725212|NCT05063097|Other|Fagerström questionnaire|Tobacco consumption will also be evaluated for each patient using a Fagerström questionnaire.
15725213|NCT05063097|Other|Exhaled carbon monoxide (CO) measurement|Active smoking will also be systematically investigated in all patients using a standardized exhaled carbon monoxide (CO) measurement with a CO-Check Pro device (Bedfont Scientific Ltd, Kent, UK) on arrival, with a measure of > 3 parts per million (ppm) signifying active smoking.
15725214|NCT05063084|Procedure|Optiflow - HFNO|Pre-oxygenation: HFNO with a 2 L/Kg/min flow during 2 min with 100% FiO2 Oxygenation: during the tracheal intubation, HFNO with a 2 L/Kg/min flow during 2 min with 100% FiO2
15725215|NCT05063084|Procedure|Classic|Pre-oxygenation: with facemask during 2 min with 100% FiO2, flow 6 to 8L/min. No oxygenation during the tracheal intubation
15725216|NCT05063071|Drug|Tenofovir Alafenamide 25 MG|After orthotopic liver transplant, all patients will receive Tenofovir Alafenamide monotherapy without HBIG for HBV Prophylaxis.
15725217|NCT05063058|Drug|Molecular guided therapy|Biomarker-driven therapy according to recommandations of the precision oncology tumor board including MEK Inhibitors (Trametinib 2 mg/d, Selumetinib 75 mg 2/d), MET Inhibitors (Crizotinib 250 mg 2/d, or Cabozantinib 60mg/d), RAS Inhibitor (Sorafenib 400 mg 2/d), Cell cycle Inhibitor (Palbociclib 125 mg/d) and Checkpoint Inhibitor (Nivolumab 240 mg every 2 weeks).
15725218|NCT05063045|Behavioral|smart-cloth assisted home nursing care|Older persons with dementia or hip fracture were asked to wear a smart vest, which contained a coin-size monitor in a hidden inner pocket. Sensors were installed in bedrooms and living areas to receive signals from the smart clothing. The home care nurses then gave feedback from the sensor signals to family caregivers.
15725219|NCT05063032|Other|Radiofrecuency ablation|Radiofrequency ablation to treat left atrial flutter, guided by high-density mapping versus linear ablation.
15725361|NCT05061836|Drug|2.5%Dextrose equivalence|5%dextrose in normal saline (5%DNSS) infused ½ of maintenance rate
15725675|NCT05059197|Dietary Supplement|Placebo|placebo
15725223|NCT05062993|Procedure|caudal epidural pulse radio frequency|A needle is inserted into the caudal epidural space under ultrasound guidance and pulse radiofrequency is administered at 5 Hz using a 5. ms pulse width for 600 seconds at 55 V.
15725224|NCT05062980|Biological|quaratusugene ozeplasmid|Quaratusugene ozeplasmid is an experimental nonviral immunoogene therapy utilizing the TUSC2 gene, designed to target cancer cells by interrupting cell signaling pathways that allow cancer cells to grow, re-establishing pathways that promote cancer cell death and modulating the immune system response against cancer cells.
15725225|NCT05062980|Drug|Pembrolizumab Injection [Keytruda]|pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody indicated for treatment of patients with metastatic NSCLC.
15725226|NCT05062980|Drug|Docetaxel injection|docetaxel is a microtubule inhibitor indicated for locally advanced or metastatic NSCLC after platinum-based chemotherapy failure.
15725227|NCT05062980|Drug|Ramucirumab Injection [Cyramza]|ramucirumab is a human vascular endothelial growth factor receptor 2 (VEGFR2) antagonist indicated for in combination with docetaxel for treatment of NSCLC with disease progression after platinum-based chemotherapy.
15725228|NCT05062954|Dietary Supplement|Polyphenol-rich cranberry extract supplement standardized in proanthocyanidins|Participants will be randomly assigned to the consumption of one capsule of Polyphenol-rich cranberry extract standardized in PACs.
15725229|NCT05062954|Dietary Supplement|Placebo supplement|Participants will be randomly assigned to the consumption of one capsule of placebo per day for 56 consecutive days.
15725230|NCT05062941|Other|Conventional physiotherapy|Conventional therapy (CT) included application of 15 minutes of hot-pack, 20 minutes of transcutaneous electrical nerve stimulation, 5 minutes of ultrasound, 20 minutes of interference current with vacuum electrodes, and exercises.
15725231|NCT05062941|Device|High-intensity laser therapy (HILT)|"HILT stimulates oxidation of mitochondria and ATP creation by delivering high energy output inside the tissues and with this photochemistry effect, metabolism and blood circulation is increased resulting HILT to cause quick absorption of edema and removal of exudates.
~HILT (BTL 6000, BTL Industries, Inc., USA) application was to the shoulder area in the analgesic mode of the device at a frequency of 25 Hz with a power of 10 W and a dosage of 12 j/cm2 for 2 minutes: 5 sessions a week for 3 weeks and 15 sessions in total."
15725233|NCT05062915|Diagnostic Test|HINTS|HINTS (Head Impulse, Nystagmus, test of skew) V-HIT (Head impulse test google assisted) MRI: 3-4 MRI of the brain including the posterior fossa Vestibular rehabilitation for all patients with a vestibular deficit.
15725234|NCT05062902|Device|High Density Surface Electromyographic, precision botulinum neurotoxin injection guidance medical device|A personalized, precision botulinum neurotoxin injection guidance medical device, utilizing an intra-vaginal high-density surface EMG system to optimize the treatment outcomes in chronic pelvic pain (CPP) management.
15725235|NCT05062902|Drug|Botulinum Neurotoxin|Botulinum neurotoxin will be injected into the pelvic floor muscles following either a standard template (standard injection arm), or guided using high-density surface EMG (guided arm).
15725236|NCT05062889|Drug|5-Fluorouracil continuous infusion FOLFOXIRI schedule|3200 mg/sqm 48 h-continuous infusion, starting on day 1. To be repeated every two weeks for a maximum of 12 cycles.
15725237|NCT05062889|Drug|5-Fluorouracil bolus FOLFOX schedule|400 mg/sqm iv bolus, day 1. To be repeated every two weeks for a maximum of 12 cycles.
15725238|NCT05062889|Drug|5-Fluorouracil continuous infusion FOLFOX schedule|2400 mg/sqm 48 h-continuous infusion, starting on day 1. To be repeated every two weeks for a maximum of 12 cycles.
15725239|NCT05062889|Drug|Oxaliplatin FOLFOX and FOLFOXIRI schedule|85 mg/sqm iv over 2 hours, day 1. To be repeated every two weeks for a maximum of 12 cycles.
15725240|NCT05062889|Drug|Oxaliplatin CAPOX schedule|130 mg/sqm iv over 2 hours, day 1. To be repeated every three weeks for a maximum of 8 cycles.
15725241|NCT05062889|Drug|L-Leucovorin|200 mg/sqm iv over 2 hours, day 1. To be repeated every two weeks for a maximum of 12 cycles.
15725242|NCT05062889|Drug|Capecitabine|Capecitabine 1000 mg/sqm/bid per os from day 1 to day 14. To be repeated every 3 weeks until 8 cycles. Available as 500 and 150 mg tablets.
15725243|NCT05062889|Drug|Irinotecan|165 mg/sqm iv over 60 minutes, day 1. To be repeated every two weeks for a maximum of 12 cycles.
15725244|NCT05062889|Drug|Trifluridine/Tipiracil|35 mg/m2/bid per os days 1-5 and 8-12. To be repeated every 4 weeks until 6 cycles. Available as 20 and 15 mg tablets.
15725247|NCT05062863|Device|T3 dental implant system|This clinical study will evaluate patients being treated with the T3 dental implant to confirm its safety and performance (effect of treatment of edentulism). The patients treated will experience a benefit from treatment of edentulism with the T3 dental implant system. The patients will be followed prospectively from the time of exposure (dental implant placement surgery) to outcome (implant survival at 2 years).
15725248|NCT05062850|Other|observation|Our study does not involve an intervention. Chronic diseases and geriatric syndromes of the participants will be studied.
15725249|NCT05062837|Drug|Hepatectomy Combined With Camrelizumab and Apatinib|Patients with CNLC IIIb hepatocellular carcinoma will receive hepatectomy. Two to four weeks later, they will receive camrelizumab and apatinib treatments.
15725362|NCT05061836|Drug|Dextrose 5|5%dextrose in normal saline (5%DNSS) infused with maintenance rate
15725250|NCT05062824|Behavioral|Baby Feed|Baby Feed web portals can (1) Quickly and easily evaluate infant diet using a validated Infant Food Frequency Questionnaire (infant FFQ) developed by our group14. [Parental FFQ portal]; (2) Provide automatic results to healthcare professionals on nutrients and foods/beverages consumed above or below the recommended levels to discuss with parents for improving the infant's diet. Also, to provide recommendations for amounts of foods/beverages that the infant should be consuming by age [Clinician Portal]; (3) Give online access to parents to these diet recommendations to implement at home, with an easy tracking component [Parent's Portal].
15725253|NCT05062785|Drug|Intranasal insulin|"This will be given intranasally at differing doses depending on study day. A total of 11 possible doses will be tested, ranging from 0 to 1000 U insulin. Each volunteer will come for 5 visits.
~On the first treatment day participants will receive placebo (sterile water) in each nostril followed by a 4-hour observation period. After this observation period they will receive the initial dose of insulin squirted in each nostril followed by a a 4 hour observation period. Participants will have at least 7 days in between the other 4 visits. Subsequent visits will include increased doses of insulin (depending on how this is tolerated) and will take approximately 4 hours at these visits."
15725254|NCT05062772|Diagnostic Test|Ultrasound|Intraoperative ultrasound imaging
15725255|NCT05062759|Drug|Tezepelumab|210 mg SC injection Q4W.
15725256|NCT05062759|Drug|Placebo|SC injection Q4W.
15725257|NCT05062746|Other|Matrix-Rhythm Therapy|One session Matrix-Rhythm Therapy will be applied to affected body parts.
15725258|NCT05062746|Other|Conventional physiotherapy and rehabilitation|Hemiparetics wil receive one session conventional physiotherapy and rehabilitation.
15725259|NCT05062720|Radiation|Local consolidative therapy|Local Consolidative Therapy (LCT) will be defined as surgical resection or stereotactic body radiotherapy (SBRT) or a combination of both strategies
15725260|NCT05062707|Procedure|Blood sampling|Study measurements will be performed twice and consist of blood withdrawal and physical examination (weight, height, waist-hip ratio, and blood pressure).
15725261|NCT05062694|Other|Survey|It will be created a questionnaire to investigate, among Italian physiotherapists, their clinical approach to the patient with Central Sensitisation
15725262|NCT05062681|Drug|Dexamethasone|Patients will receive dexamethasone 8 mg q12hours
15725263|NCT05062681|Drug|Methylprednisolone|Patients will receive 1mg/kg/day in 2 divided doses over 30 minutes
15725264|NCT05062668|Procedure|cataract operation and istent|a cataract operation and the placement of one or two iStent inject or inject W at the same time
15725265|NCT05062668|Procedure|cataract operation only|Patients have a classic postoperative treatment after cataract.
15725266|NCT05062655|Other|Drug reconciliation|Drug reconciliation information transmission to pharmacist interview with the patient
15725267|NCT05062629|Genetic|Whole Genome Sequencing|Whole Genome Sequencing
15725269|NCT05062590|Other|Recommendations|Ressources recommendations and interventions curated to the needs of the EP such as refering them to a social activity for socially isolated EP
15725270|NCT05062577|Drug|ASP8062|oral
15725271|NCT05062577|Drug|Placebo ASP8062|oral
15725272|NCT05062577|Drug|buprenorphine/naloxone|sublingual
15725273|NCT05062564|Device|LipiFlow Thermal pulsation system|Single treatment with LipiFlow thermal pulsation system on the eyelids within two months before surgery
15725274|NCT05062564|Procedure|Eyelid warm compresses plus massages|Eyelid warm compresses plus massages twice a day for the preoperative month
15725275|NCT05062551|Procedure|three steps hysteroscopic resection of an isthmocele|removing the distal edge of the niche then the proximal edge and lastly ball cauterization of the floor of the pouch of the isthmocele. Post-operative trans vaginal ultrasound and follow up for 2 menstrual cycles.
15725276|NCT05062499|Device|Active TENS|electrical stimulation
15725277|NCT05062499|Device|Sham TENS|no stimulation
15725278|NCT05062486|Drug|Resveratrol, Quercetin, Curcumin (RQC)|100 mg resveratrol, 120 mg quercetin, 1000 mg curcumin BID
15725279|NCT05062486|Drug|Curcumin|1000 mg curcumin BID
15725283|NCT05062434|Other|Academic detailing and audit and feedback intervention|An academic detailing and audit and feedback intervention will be presented to VA cardiac electrophysiologists, and will include quantitative data about the individual physician's facilities cardiovascular implantable electronic device lead implants and national data on lead implants over the past year.
15725284|NCT05062395|Procedure|Computed Tomography|Undergo FDG PET CT
15725285|NCT05062395|Other|Fludeoxyglucose F-18|Undergo FDG PET CT
15725286|NCT05062395|Other|Low Carbohydrate High Fat Diet|low carbohydrate and high fat diet for 48-72 hours
15725287|NCT05062395|Procedure|Positron Emission Tomography|Undergo FDG PET CT
15725400|NCT05061563|Drug|Esomeprazole|Esomeprazole given orally once daily for 5 days in Period 2.
15725401|NCT05061550|Drug|Durvalumab|Participants will receive Durvalumab via intravenous route before surgery and after surgery.
15725402|NCT05061550|Drug|Oleclumab|Participants will receive Oleclumab via intravenous route before surgery and after surgery.
15725403|NCT05061550|Drug|Monalizumab|Participants will receive Monalizumab via intravenous route before surgery and after surgery.
15725288|NCT05062382|Behavioral|Complementary feeding intervention|"The study promoted two main products: 1) Cerifam, a fortified complementary food popular in Ethiopia, and 2) eggs.
~GAIN supported Faffa Food to redesign and label their Cerifam product, developed a manual for the manufacturing of complementary food and trained processors and regulators, provided Faffa Food with technical expertise to develop a business model, and financially and technically support the Ethiopian Standard Agency to develop a national standard for formulated complementary foods.
~GAIN provided training to egg farmers to increase their egg production and marketing, helped increase mother's access to eggs by making them more available in local kiosks and getting retailers to display promotional messages around eggs, conducted sensitization workshops with retailers to increase egg purchases, and employed a demand creation campaign."
15725289|NCT05062369|Device|TaskFlow Transcranial Electrical Stimulation device|The TaskFlow Transcranial Electrical Stimulation device (TaskFlow-TES) is a custom brain stimulation device developed in-house at the University of Minnesota. Each tDCS intervention will last 20 minutes of either (i) 10 active (2-mA) or (ii) 5 active and 5 sham transcranial direct current stimulation (tDCS) over the course of 10 treatment sessions.
15725290|NCT05062369|Behavioral|Executive Function Focused Cognitive Training|Working memory focused training occurs on a computer and consists of a variety of exercises selected to (i) place demands on the executive and storage functions of working memory (ii) adapt to challenge the participant's current ability level, (iii) provide ongoing feedback, and (iv) present novel stimuli across verbal, visual and spatial modalities. Training tasks are developed in-house. Tasks for each participant are delivered from and responses, audio, and video are stored on the HST server. The aim of using multiple tasks that require executive functions is to engage brain network functional connectivity in a number of different ways to promote generalization. Investigators will monitor each participant's training and customize the intervention to balance challenge and engagement. In addition, pre- and post-intervention, participants will perform 4-minute versions of a word and a spatial 3-back task identical across all weeks (but differing from the assessment versions).
15725291|NCT05062356|Drug|Bupivacaine Hydrochloride 0.25% Injection Solution_#2|40cc
15725292|NCT05062356|Drug|EPINEPHrine 1:200,000 / Prilocaine HCl 4 % 1.8 ML Cartridge|10cc
15725293|NCT05062356|Drug|Bupivacaine Hydrochloride 0.5% Injection Solution_#2|20cc
15725294|NCT05062356|Drug|Ketorolac|15mg
15725295|NCT05062343|Device|Dilapan-S|Osmotic dilator
15725296|NCT05062343|Device|Cook Cervical Ripening Balloon|Double balloon catheter for cervical ripening
15725297|NCT05062330|Drug|Reproxalap Ophthalmic Solution (0.25%)|Reproxalap Ophthalmic Solution (0.25%) administered 7 times over two consecutive days
15725298|NCT05062330|Drug|Vehicle Ophthalmic Solution|Vehicle Ophthalmic Solution administered 7 times over two consecutive days
15725299|NCT05062317|Drug|Leucovorin|Given by PO
15725300|NCT05062317|Drug|5-FLUOROURACIL|Given by IV
15725301|NCT05062317|Drug|Oxaliplatin|Given by PO
15725302|NCT05062317|Drug|Irinotecan|Given by IV
15725303|NCT05062317|Drug|Capecitabine|Given by IV
15725304|NCT05062317|Drug|Bevacizumab|Given by IV
15725305|NCT05062304|Drug|Fluticasone Furoate-Vilanterol Trifenatate|Fluticasone Furoate-Vilanterol Trifenatate dispensing claim is used as the reference group.
15725306|NCT05062304|Drug|Furoate-umeclidinium-vilanterol|Furoate-umeclidinium-vilanterol dispensing claim is used as the exposure group.
15725307|NCT05062291|Device|Merit WRAPSODY Endovascular Stent Graft|Target Lesion Primary Patency (TLPP)
15725310|NCT05062265|Device|Tight rope fixation|a traditional tight rope fixation is performed on one randomized set of subjects
15725311|NCT05062265|Device|Tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace|A tight rope fixation with an anterior inferior tibiofibular ligament (AITFL) repair augmentation with an internal brace set of subjects to compare syndesmotic volume
15725312|NCT05062252|Device|Mirror Medacta Shoulder System|Anatomic total shoulder arthroplasty system
15725313|NCT05062252|Device|Medacta Shoulder System|Anatomic total shoulder arthroplasty system - standard configuration
15725314|NCT05062239|Drug|Discontinuance of treatment with statins 7 to 14 days prior to surgery until 30 days postoperative|Discontinuance of prior statin therapy
15725315|NCT05062239|Drug|No-intervention.|Continuance of prior statin therapy
15725316|NCT05062226|Dietary Supplement|PKU/TYR GMP Protein Substitute|After a 1-day baseline period during which patients will consume their usual protein substitute, each patient will receive one the case study product for 4 weeks (28 days).
15725317|NCT05062213|Other|Moisturizer Body Lotion|Moisturizer Body Lotion
15725318|NCT05062200|Drug|JNJ-77242113|JNJ-77242113 will be administered as an oral tablet.
15725319|NCT05062200|Drug|Placebo|Matching placebo will be administered as an oral tablet.
15725320|NCT05062187|Other|Proprioseption in hemiparetics|Proprioception on balance and gait functions in hemiparetic individuals
15725321|NCT05062174|Drug|Mifepristone 200 MG|Orally, one time dosage of 200 mg
15725322|NCT05062174|Procedure|Prophylactic mastectomy|Planned prophylactic mastectomy (having one or both breasts removed).
15725323|NCT05062161|Behavioral|Sleep hygiene/extension intervention|The 60-minute sleep hygiene/extension educational session include the following: This session will consist of questionnaires, handouts, videos, and a discussion. Topic examples include information on establishing a comfortable sleep environment, including strategies on how to extend sleep duration by a maximum of 1 hour over the duration of the 8-week trial for an average of 7.5 minutes per week, not to exceed 15 minutes per week. Participants will also receive educational brochures and a sleep diary.
15725324|NCT05062161|Behavioral|Control care|The 60-minute educational session will address sleep physiology but not sleep hygiene. This session will consist of questionnaires, handouts, videos, and a discussion. Participants will receive an educational brochure.
15725325|NCT05062148|Other|Float-REST|Subjects receiving Float-REST will float for 60 minutes three times a week.
15725326|NCT05062148|Other|Photobiomodulation|Subjects receiving photobiomodulation will undergo a 20-minute therapy session three times a week.
15725327|NCT05062135|Drug|Progesterone 400 Mg Vaginal Suppository on PCOS|The same drug will be used in control group
15725329|NCT05062109|Behavioral|Multimodal geriatric prehabilitation|"Multimodal prehabilitation will be carried out over a period of 6 weeks in a day admission (once a week) and at home, and will include:
~Muscle rehabilitation developed with a physiotherapist or physical activity monitor
~Nutritional support (dietitian at the 1st, 3rd, and 6th day admission (DA))
~Cognitive and physical stimulation Exergame
~Psychological support by a psychologist
~Information in the form of videos on the main risks and important points to know and prepare before and after surgery
~Assessment of patient satisfaction, any limitations encountered, the possible performance of exercises at home and the occurrence of any adverse effects.
~One session of adapted physical activity at home of one hour per week by a physical trainer from the Siel Bleu association"
15725330|NCT05062096|Other|Blood samples|Blood samples at each protocol visit, T and NK cell analysis
15725331|NCT05062096|Other|Skin biopsy|Biopsy of the skin lesion (optional)
15725333|NCT05062070|Drug|TolaSure Topical Gel|TolaSure Topical Gel is applied once-daily for up to 10 weeks to designated Treatment Area and Suction Blister Area.
15725334|NCT05062070|Drug|Vehicle Topical Gel|TolaSure Vehicle Gel is applied once-daily for up to 10 weeks to designated Treatment Area and Suction Blister Area.
15725343|NCT05062005|Drug|Induction Chemotherapy|Induction regimens: TP (docetaxel 75 mg/m²; cisplatin 75 mg/m²) Q3w, TPF (docetaxel 60 mg/m²; cisplatin 60 mg/m²; 5-fluorouracil 600-750 mg/m² per day, continuous intravenous infusion d1-5) Q3w, or GP (gemcitabine: 1000 mg/m2 d1, d8; cisplatin 80 mg/m2) Q3w.
15725344|NCT05062005|Drug|Concurrent Chemotherapy|Cisplatin 100 mg/m², Q3w.
15725345|NCT05062005|Radiation|Definitive Radiotherapy|For all patients, the prescribed dose is 66-70 Gy (once a day, 5 times a week).
15725348|NCT05061966|Behavioral|immi|The intervention has four main content areas: 1) gender identity (the gender guide), 2) sexual orientation (the queerness guide), 3)stress and coping (the stress guide), and 4) internalized stigma (the internalized stigma guide).
15725349|NCT05061966|Behavioral|Control|The control will have access to resources on the website, but will not receive any engagement reminders, matching the conditions present in real world contexts in which web-based resource lists are available.
15725350|NCT05061953|Device|Eye-Tracking|Eye-tracking technology and algorithms used to successfully capture and track eye movements using an electronic tablet and the embedded camera of the device.
15725351|NCT05061940|Diagnostic Test|Tumor Profiling|Testing TAA and HPV expression. HLA typing.
15725353|NCT05061914|Procedure|pericardial effusion drainage|tamponading pericardial effusion is a life threatenning condition , pericardiocentesis is performed for patients who are vitally unstable and with a massive amount of effusion to prevent cardiac tamponade, Surgical drainage of pericardial effusion was classically conducted by either open thoracotomy or subxiphoid pericardiectomy. Thoracoscopy has established itself as an alternative to open thoracotomy for the management of many pericardial, pleural and pulmonary disorders
15725354|NCT05061901|Drug|Lisinopril tablet 20 mg|Lisinopril is manufactured by Pharmtechnology LLC, Belarus. Each tablet contains 20 mg of lisinopril.
15725355|NCT05061901|Drug|Zestril® tablet 20 mg|Zestril® is manufactured by Avara Reims Pharmaceutical Services, France. Each tablet contains 20 mg of lisinopril.
15725356|NCT05061888|Other|Smart Intervention for Food Waste Management and Replacing current diet with Fruits and Vegetables|Will receive a Smart Intervention on Food Waste Management and replacing less healthy foods with fruits and vegetables.
15725357|NCT05061888|Other|Smart Intervention for Stress Managment|Will receive a Smart Intervention on stress management practices and strategies.
15725358|NCT05061862|Device|cardiac implantable electronic devices (CIEDs)|Subjects will be implanted with various cardiac implantable electronic devices and followed according to their standard of care. Medical imaging will be collected at various stages of the implant procedure
15725359|NCT05061836|Drug|Ringer acetate|Patient will receive Acetate Ringer's solution (Acetar) infused at maintenance rate
15725360|NCT05061836|Drug|1.25%Dextrose equivalence|5%dextrose in normal saline (5%DNSS) infused ¼ of maintenance rate
15725363|NCT05061823|Drug|Bintrafusp alfa|Participants who are continuing treatment with bintrafusp alfa and were previously assigned to a bintrafusp alfa dose based on body weight which is (i.e.) milligrams per kilogram (mg/kg) per dose in a parent protocol, will receive an intravenous infusion of bintrafusp alfa at the dose specified based upon the participant's parent protocol once every 2 week or, 2400 mg once every 3 weeks. Participants who are entering the rollover study after discontinuation of treatment in a parent study will receive bintrafusp alfa at a dose of either 1200 or 2400 mg once every 2 weeks or 2400 mg once every 3 weeks until confirmed disease progression, death, unacceptable toxicity or study withdrawal.
15725365|NCT05061797|Dietary Supplement|Thermogenic Energy Drink - Active Study Product Formula|The Thermogenic Energy Drink is the Active Study Product (ASP). This energy drink formula combines, caffeine, guarana, Vitamins C, B3, B6, B12, Magnesium, Potassium, L-Citrulline, L-Arginine HCl, L-Glutamine, and Chlorogenic Acids from green coffee bean extract. Participants will consume an assigned amount of the beverage (355 ml), under observation. They will be monitored for the following 180 minutes with measurements of respiration for Resting Energy Expenditure (RER) and other metabolic markers as well as satiety via Visual Analog Scale (VAS).
15725366|NCT05061797|Dietary Supplement|Placebo|A carbonated soft drink with the same appearance, flavor and aroma as the active study product. Study participants will consume an assigned amount of the beverage (355 ml) under observation. They will then be monitored for the subsequent 180 minutes with measurements for respiration for Resting Energy Expenditure (RER) and other metabolic markers as well as satiety via a Visual Analog Scale (VAS).
15725367|NCT05061784|Procedure|Routine thymectomy, which has been performed|There is no intervention
15725368|NCT05061771|Drug|nomacopan (rVA576)|Nomacopan an inhibitor of complement C5 and LTB4
15725369|NCT05061771|Other|Placebo|Placebo
15725370|NCT05061758|Drug|LY3056480|LY3056480 is an inhibitor of gamma-secretase
15725371|NCT05061745|Device|Guided Meditation VR for Wellness|"Selected Modules of Commercially Available Guided Meditation VR presented on Valve Index Headset"
15725372|NCT05061745|Device|Accelerated Transcranial Magnetic Stimulation: Treatment A|MagVenture Transcranial Magnetic Stimulation (Treatment Coil Cool B70 AP)
15725373|NCT05061745|Device|Accelerated Transcranial Magnetic Stimulation: Treatment B|MagVenture Transcranial Magnetic Stimulation (Cool D-B80 AP)
15725374|NCT05061732|Drug|Rabeprazole|20mg bid
15725375|NCT05061732|Drug|Bismuth potassium citrate|0.6g bid
15725376|NCT05061732|Drug|Metronidazole|0.4g qid
15725377|NCT05061732|Drug|Clarithromycin|0.5g bid
15725378|NCT05061732|Drug|Levofloxacin|0.5g qd
15725379|NCT05061732|Drug|Amoxicillin|1g tid
15725380|NCT05061732|Drug|Metronidazole|0.4g tid
15725381|NCT05061732|Drug|Doxycycline|0.1g bid
15725382|NCT05061732|Drug|Tetracycline|0.5g qid
15725383|NCT05061719|Drug|Lumateperone|Lumateperone 42 mg capsules administered orally, once daily
15725384|NCT05061706|Drug|Lumateperone|Lumateperone 42 mg capsules administered orally, once daily.
15725385|NCT05061706|Drug|Placebo|Matching capsules administered orally, once daily.
15725389|NCT05061667|Procedure|Thoracic Paravertebral Block|Paravertebral block for postoperative analgesia in thoracic surgery
15725390|NCT05061667|Procedure|Rhomboid Block|Rhomboid block for postoperative analgesia in thoracic surgery
15725391|NCT05061654|Drug|Ceftolozane-tazobactam IV|Empiric Ceftolozane-tazobactam IV 3g over 1 hour every 8 hours. The dose will be reduced to 1.5g 8 hourly in patients with CrCl of 30-50 ml/min, and to 750mg every 8 hours in those with CrCl of 15-29 ml/min. Patients on hemodialysis will receive 2.25g loading dose followed by 450mg every 8 hours.
15725392|NCT05061641|Drug|Progesterone|The delivery outcomes of the three groups were compared, including the rate of premature delivery (<37 weeks of gestation), the rate of early premature delivery (<32 weeks of gestation), and the need for anti-tocolysis treatment. Rates of premature rupture of membranes (<37 weeks), neonatal perinatal mortality and morbidity.
15725393|NCT05061628|Drug|JS006 as Monotherapy|"JS006 as Monotherapy dose-escalation: JS006, 18/ 60/ 180/ 600/ 1800mg, IV infusion, every 3 weeks (q3w).
~JS006 as Monotherapy dose-extension: JS006, 1 or 2 specific dose, IV infusion, every 3 weeks (q3w)."
15725394|NCT05061628|Drug|JS006 in combination with Toripalimab|"JS006 in combination with Toripalimab dose-escalation: JS006, 2 or 3 specific dose, IV infusion, every 3 weeks (q3w), combined with Toripalimab, 240mg, IV infusion, every 3 weeks (q3w).
~JS006 in combination with Toripalimab dose-extension: JS006, 1 or 2 specific dose, IV infusion, every 3 weeks (q3w), combined with Toripalimab, 240mg, IV infusion, every 3 weeks (q3w).
~JS006 in combination with Toripalimab indications expansion: JS006, RP2D, IV infusion, every 3 weeks(q3w), combined with Toripalimab, 240mg, IV infusion, every 3 weeks (q3w)."
15725395|NCT05061602|Diagnostic Test|Evaluation of biomechanics and viscoelastic properties of plantar fascia|The biomechanical and viscoelastic properties of the plantar fascia will be measured with the MyotonPRO device.
15725396|NCT05061589|Procedure|permanent colostomy|An operation that creates an opening for the colon through the abdomen
15725397|NCT05061576|Behavioral|Standard of Care advice on physical activity|Oral advice on exercise from a physician.
15725398|NCT05061576|Behavioral|Structured advice on physical activity|A leaflet with instructions and images on different forms of physical activities as well as clear recommendations on when to perform these.
15725399|NCT05061563|Drug|Elinzanetant (BAY3427080)|Elinzanetant given orally as single dose capsule and intravenous as single dose in Period 1. Elinzanetant given orally as single dose capsule in Period 2.
15725409|NCT05061511|Other|Analysis of inflammasome expression|RNA isolation, spectrophotometric quantification, reverse transcription to cDNA and relative quantification of gene expression using a quantitative reverse transcription polymerase chain reaction (qRT-PCR). Specific inflammasome-related transcripts will be investigated, including ASC, caspase-1, IL-1beta, IL-18, NLRP3, NLRP2, AIM2, POP1, POP2, CARD16, CARD18, TRIM16, and TRIM20. A qRT-PCR System (e.g. StepOne Plus, Applied Biosystems) will be used for the amplification and analysis of the PCR products. Expression data will be reported as the ratio between each investigated target gene and GAPDH (used as housekeeping endogenous control).
15725410|NCT05061511|Other|Histological analysis|"gingival tissue samples will be prepared for paraffin inclusion and different stains will be used to evaluate the histological features of the tissues, distribution of inflammatory cells and alignment of collagen fibers.
~Moreover, a trained examiner will assess semi-quantitatively the inflammatory infiltrate under light microscopy.
~The expression of inflammatory/immune-related proteins such as NLRP3, ASC-2, IL-1beta and IL-18 protein expressions will be compared among the three groups by immunodetection methods"
15725411|NCT05061498|Diagnostic Test|Additional Pacing maneuvers|In order to determine the optimal setting for pacemapping in all participants additional pacing maneuvers (output and cycle length) are performed
15725412|NCT05061485|Other|Sucrose|The participants consume A) water with 75 g sucrose
15725413|NCT05061485|Other|Sucrose + protein|The participants consume B) water with 75 g sucrose + approx. 100 kcal protein
15725414|NCT05061485|Other|Sucrose + fat|The participants C) water with 75 g sucrose + approx. 100 kcal fat
15725415|NCT05061459|Genetic|circANKRD36 as a new biomarker|expression levels of circANKRD36 in the development and progression of DN
15725416|NCT05061446|Drug|Etrasimod|Etrasimod tablet by mouth, once daily for 12 weeks
15725417|NCT05061446|Drug|Etrasimod|Etrasimod tablet by mouth, once daily for 12 weeks
15725418|NCT05061446|Drug|Placebo|Etrasimod matching placebo tablet by mouth, once daily up to 12 weeks
15725419|NCT05061433|Other|Mobile Integrated Healthcare/Community Paramedicine (MIH/CP) Support|MIH/CP provider and their team will offer additional support and connection to resources after patient is discharged from hospital.
15725423|NCT05061381|Behavioral|A Lust for Life Schools Programme|A Lust for Life is a universal school-based multi-component programme whose target is to build well-being and emotional resilience in children. The programme was informed by evidence-based psychological approaches including mindfulness, cognitive behaviour therapy and positive psychology. It is delivered in six weekly lessons by the childrens' school teacher and involves classroom discussions, videos, classroom activities and homework assignments.
15725424|NCT05061368|Drug|Sildenafil Citrate|Phosphodiesterase Type 5 inhibitor. Known to potentiate nitric oxide mediated vasodilation.
15725425|NCT05061368|Other|Placebo|Placebo
15725426|NCT05061355|Procedure|Heart valve surgery|Heart valve surgery will be performed as soon as possible and preferably within 48 hours
15725427|NCT05061342|Other|No experimental interventions 1. Observation; 2. Anticancer treatments, including surgery, systemic therapy, radiotherapy, Chinese traditional medicine, or palliative/supportive care.|Any anticancer or palliative care
15725428|NCT05061316|Dietary Supplement|Nestlé Impact Advanced Recovery|Immunonutrition drink that helps support the immune system: reduces risk of prolonged hospital stay and complications after surgery.
15725429|NCT05061303|Other|Assessment of the drug concentration in the blood|The material in the study will be blood, in which tacrolimus concentrations will be measured at the following time points: 0, 2hours, 6hours, 12hours after drug administration, without taking omeprazole/famotidine and then the next day after taking the protective drug in same time points, without 12hours. Sequentially routinely in the so-called point T0 before taking the drug (12 hours after the last dose) during follow-up visits at the Transplant Outpatient Clinic.
15725430|NCT05061290|Other|Control Porridge|Maize porridge containing 54Fe as iron sulfate
15725431|NCT05061290|Other|Reference Porridge A|Maize porridge counting 58Fe as iron sulfate with ascorbic acid
15725432|NCT05061290|Other|Test Porridge B|Maize porridge containing 57Fe and fortified with Moringa leaf powder as iron source
15725433|NCT05061290|Other|Test Porridge C|Maize porridge containing 57Fe and fortified with Boabab fruit powder as iron source
15725434|NCT05061290|Other|Test Porridge D|Maize porridge containing 54Fe and fortified with Moringa leaf and Baobab fruit powder as iron source
15725435|NCT05061277|Drug|Recifercept|A lyophilized powder for solution for injection
15725436|NCT05061264|Procedure|Abdominal wall reconstruction|The repair of abdominal wall defects with polyvinylidene (PVDF) mesh
15725437|NCT05061251|Drug|BAY 2402234|Patients will receive 3 doses of 5mg each of BAY 2402234. Drug will be given Day 1 and Day 2 prior to standard-of-care craniotomy for tumor resection and 1 dose on the morning of surgery.
15725438|NCT05061238|Device|Vibrating Device|The vibrating device strapped to different parts of your leg. The device will be secured to your leg with a Velcro strap.
15725439|NCT05061225|Behavioral|Physical activity counselling|Educational content on several topics regarding physical activity and its implementation in daily living
15725440|NCT05061199|Procedure|approach of anastomosis|The approach of anastomosis
15725441|NCT05061186|Other|Resistive Expiratory muscle Training Group|"Mild Resistive Expiratory Technique [Expiratory Muscle Strength Training (EMST150)- six-week training protocol approximately 20 min per day] The EMST requires the participant to forcibly blow into the device for 5 seconds with sufficient pressure to open the one-way valve. Each blow is one repetition. The device will be set at a resistance of 30 cmH2O. Participants will be instructed to complete five sets of five repetitions (total of 25 times and approximately 20 minutes per day), any five days per week, for six weeks. Whole exercise will be done in sitting position. Rest between repetitions will be given according to comfort level of patient."
15725463|NCT05061017|Drug|Pixatimod|Pixatimod is an investigational drug that is being evaluated in studies involving melanoma, non-small cell lung cancer, and microsatellite stable colorectal cancer.
15725442|NCT05061186|Other|Conventional Breathing Exercise Group|"Breathing Exercises: (approximately 20 minutes per day)
~● Pursed lip breathing: (Sit with your back straight. Inhale through your nose for two seconds. Purse your lips like you're blowing on hot food and then breathe out slowly, taking twice as long to exhale as you took to breathe in. 4-5 times a day)
~● Diaphragmatic breathing: (Lie on your back on a flat surface, knees bent and head supported. Use pillow under knees to support your legs. Breathe in slowly through your nose Tighten your stomach muscles, letting them fall inward as you exhale through pursed lips. Practice this exercise 5-10 minutes about 3-4 times per day).
~● Incentive spirometer: (Hold in an upright position. Breathe in slowly and as deeply as possible. Hold your breath as long as possible (at least for 5 seconds). Then exhale slowly Rest for a few seconds and at least 10 times every hour)"
15725446|NCT05061160|Other|Interval Aerobic Exercise training Group|"Interval Aerobic exercise will be on upper limb Bicycle with a pause of 3 mins interval Interval Aerobic Exercises: Frequency= 3 times per week Intensity= 50% of heart rate reserve for 2 mins 80% of heart rate reserve for 1 min Type= interval aerobic exercise Time= 40 minutes
~There will be 5 minutes for warm up and 5 minutes for cool down."
15725447|NCT05061160|Other|Continuous Aerobic Exercise training Group|"Continuous Aerobic exercise will be on upper limb Bicycle Continuous Aerobic Exercise: Frequency= 3 times per week Intensity= 50% of heart rate reserve Type= continuous aerobic exercise Time= 40 minutes
~There will be 5 minutes for warm up and 5 minutes for cool down."
15725448|NCT05061147|Drug|MAX-40279-01|"Drug: AZA AZA will be administered at 75 mg/m^2 by subcutaneous injection for 7 consecutive days from D1 to D7 in 28-day treatment cycles.
~Other Name: Azacitidine
~Drug: Max-40279-01 Max-40279-01 will be administered as a combination of multiple oral capsules containing 5 and 25 mg. An alternate combination of 35 mg, 50 mg and 60 mg Max-40279-01 twice a day may be utilized.
~Other Name: NA"
15725451|NCT05061121|Other|combined effect|Compare the short- and mid-term effects of Mulligan's SNAGs, Myofascial release, and their combination on pain intensity, pain pressure sensitivity, cervical function, range of motion (ROM) and postural stability in CNSNP patients
15725452|NCT05061108|Behavioral|PAL2|Community health worked based intervention to mitigate psychosocial and life circumstance barriers to optimize health promotion coupled with high blood pressure and lifestyle disease state education
15725455|NCT05061069|Diagnostic Test|cervical vestibular evoked myogenic potentials (cVEMP)|cVEMPs are ipsilateral, short latency, inhibitory myogenic potentials that assess otolith (mainly saccular) function and the integrity of the inferior branch of the vestibular nerve.
15725456|NCT05061056|Other|Russian current 10%|Russian current with 2500 Hz, modulated in bursts of 50 Hz, 200 µs and 10% duty cycle - 2 ms bursts and 18 ms interbusrts
15725457|NCT05061056|Other|Russian current 20%|Russian current with 2500 Hz, modulated in bursts of 50 Hz, 200 µs and 20% duty cycle - 4 ms bursts and 16 ms interbusrts
15725458|NCT05061056|Other|Aussie current 10%|Aussie current with 1000 Hz, modulated in bursts of 50 Hz, 500 µs and 10% duty cycle - 2 ms bursts and 18 ms interbusrts
15725459|NCT05061056|Other|Aussie current 20%|Aussie current with 1000 Hz, modulated in bursts of 50 Hz, 500 µs and 20% duty cycle - 4 ms bursts and 16 ms interbusrts
15725460|NCT05061043|Other|Routine physical therapy treatment|Control group will receive the routine physical therapy treatment that will include EMS, Infrared and Intermittent stretching of facial muscles for 36 sessions on alternate days, each session comprise 30 minutes for 5 days a week
15725461|NCT05061043|Other|Routine physical therapy along with orofacial therapy|Experimental group will receive routine physical therapy along with orofacial therapy (36 sessions on alternate days, each session comprise 45 minutes)
15725462|NCT05061030|Biological|the ATMP Protrans|Protrans consists of Wharton's jelly derived mesenchymal stromal cells
15725524|NCT05060523|Other|Placebo|Placebo of Midodrine
15725464|NCT05061017|Drug|Nivolumab|Nivolumab is approved by the FDA for the treatment of melanoma, non-small cell lung cancer (NSCLC), malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of head/neck, urothelial carcinoma, MSI-H colorectal cancer, hepatocellular carcinoma, gastric carcinoma and gastroesophageal junction (GEJ) cancer
15725465|NCT05061017|Drug|Cyclophosphamide (low dose)|Cyclophosphamide is approved by the FDA for the treatment of acute lymphoblastic leukemia, acute monocytic leukemia, acute myeloid leukemia, breast cancer, chronic granulocytic leukemia, chronic lymphocytic leukemia, chronic myelogenous leukemia, Hodgkin lymphoma, multiple myeloma, mycosis fungoides, neuroblastoma, non-Hodgkin lymphoma, ovarian cancer, retinoblastoma. Low-dose (immunomodulatory) cyclophosphamide is being studied in combination with various types of immunotherapy including nivolumab and pembrolizumab
15725466|NCT05060991|Drug|Reduction in antimetabolite immunosuppression|Reduction in dose in mycophenolate mofetil/mycophenolic acid (MMF) or azathioprine before and after receiving 3rd dose vaccination
15725467|NCT05060978|Behavioral|Watch your Weight During the Holidays Program|Participants in this group will have two video call individual sessions and one video call group session. This intervention will include self-monitoring strategies (self-weighing, diet monitoring and physical activity), and nutrition counseling and education. In addition, participants in this group will receive a weighing scale to achieve self-monitoring of body weight from the beginning of the study intervention until the end of the 52-weeks follow-up.
15725468|NCT05060978|Other|Relative 5:2 Fasting|Participants in this group will will have two video call individual sessions and one video call group session. This intervention will receive eating recommendations to follow a 5:2 intermittent fasting. They will be given low-calorie menus of 550 kcal and 660 kcal, for women and men respectively, which the participants in this group will apply on fasting days. The fasting will be held twice a week and on the remaining five days, the participants will not have any type of caloric restriction (it will be ad libitum). They will only have the general recommendation to adhere to a healthy dietary pattern.
15725469|NCT05060978|Other|Control Group|Participants in this group will receive online information and a PDF file brochure during an individual video call session at the beginning of the 8-week period. This information will be about leading a healthy eating based on the norm for health promotion and education for healthy eating in Mexico (NOM-043-SSA2-2012).
15725470|NCT05060965|Drug|Nicotine lozenge|Nicotine replacement therapy
15725471|NCT05060965|Drug|Nicotine gum|Nicotine replacement therapy
15725472|NCT05060965|Drug|Nicotine patch|Nicotine replacement therapy
15725473|NCT05060965|Other|Maryland Quitline|Telephone-based tobacco cessation service
15725474|NCT05060965|Other|John Hopkins Tobacco Treatment Clinic|Clinic-based tobacco cessation service
15725475|NCT05060952|Diagnostic Test|Calprotectin Lateral Flow Test|Semiquantitative point of care photometric assay for the calprotectin level in joint fluid aspirate
15725476|NCT05060939|Diagnostic Test|COVID-19 vaccinated people|Patients with at least one dose of COVID-19 vaccine tested for SARS-CoV-2 infection with RT-PCR on respiratory specimen. RT-PCR, serological testing and viral sequencing will be applied on patient's samples
15725477|NCT05060926|Procedure|Awake prone positioning|Awake prone position as long as possible according to the patients' tolerance
15725480|NCT05060900|Procedure|Ligament Reconstruction with Allograft Ligament|Patients will undergo surgery for hand and wrist ligament reconstruction using allograft ligament.
15725481|NCT05060887|Biological|OVX836-003|One single administration intramuscularly at Day 1.
15725482|NCT05060887|Biological|Saline solution|One single administration intramuscularly at Day 1.
15725483|NCT05060861|Other|ChAdOx1 nCoV-19 vaccine|covid-19 vaccine
15725485|NCT05060822|Drug|HEC585|HEC585 Tablets，once daily
15725486|NCT05060822|Drug|Pirfenidone|Pirfenidone，three times a day
15725487|NCT05060822|Drug|Placebo|Placebo，once daily
15725488|NCT05060809|Drug|oral vitamin k1 (phylloquinone)|The enrolled patients received 5 mg of oral vitamin K1 (phylloquinone) three times /week for 6 months at the end of HD session to ensure compliance. We measured the serum dephosphorylated- uncarboxylated matrix Gla protein (dp-ucMGP) before and 6 months after vitamin K1 supplementation. In addition, plain lateral abdominal x-ray was conducted prior to and after 6 months of vitamin K supplementation to assess lumbar aorta calcification. The extent of aortic calcification score (AAC) was assessed by a semi-quantitative grading system developed by Kauppila.
15725489|NCT05060796|Biological|CXCR5 modified EGFR Chimeric Antigen Receptor Autologous T cells|The first dose group: 0.5 × 10^6/kg CAR positive T cells; The second dose group: 1.58 × 10^6/ kg CAR positive T cells; The third dose group: 5 × 10^6/kg CAR positive T cells. The above dose allows a 20 % error; For subjects with body weight greater than 60 kg, the number of cells can only be calculated according to 60 kg of body weight.
15725490|NCT05060783|Diagnostic Test|GaGnostic|Plasma
15725491|NCT05060783|Diagnostic Test|GaGnostic|Serum
15725492|NCT05060783|Diagnostic Test|GaGnostic|Urine
15725493|NCT05060770|Genetic|transcriptomic analysis|transcriptomic analysis on preserved tumor tissue
15725494|NCT05060757|Diagnostic Test|biotax|patients who are scheduled to undergo colonoscopy will be asked to participate and give a stool sample
15725495|NCT05060744|Device|Antacid|The tablets should be kept in the mouth without chewing or swallowing, allowing them to dissolve completely.
15725496|NCT05060744|Other|Control|The tablets should be kept in the mouth without chewing or swallowing, allowing them to dissolve completely.
15725497|NCT05060731|Drug|Oral iron supplementation|Ca. 200-300 mg of ferrous sulfate will be administered orally every day for 3 months.
15725498|NCT05060731|Drug|Intravenous iron supplementation|One dose of intravenous 1000 mg ferric carboxymaltose will be administered on the day of randomization.
15725678|NCT05059171|Device|WaveOne Gold single file|reciprocation motions of WaveOne Gold single file
15725499|NCT05060705|Drug|Efesovir|Antiviral therapy of COVID19 with Efesovir oral solution in dose 0.125 ml / kg two times per day. Duration of treatment is 5 - 10 days, depending on the severity of the disease.
15725500|NCT05060692|Diagnostic Test|Bloot testing|NFL measruments in serum
15725501|NCT05060679|Other|Systemic inflammatory response syndrome (SIRS) therapy|Therapy of SIRS patients was based on the international guidelines of the 2012 Surviving Sepsis Campaign (SSC) regarding respiratory, antimicrobial, anticoagulation, vasopressor and hydrocortisone therapy, along with adequate fluid resuscitation, sedation, ulcer prophylaxis and nutrition. Blood sampling points for SIRS patients were the first (T1) and third (T3) postoperative morning at the ICU. 23 patients were documented without SIRS, sepsis or sepsis-related acute kidney injury as a control group.
15725502|NCT05060679|Other|Sepsis therapy|Patients receiving sepsis therapy followed the international guidelines of the 2016 Surviving Sepsis Campaign (SSC) regarding respiratory, antimicrobial, anticoagulation, vasopressor and hydrocortisone therapy, along with adequate fluid resuscitation, sedation, ulcer prophylaxis and nutrition. Blood samples were collected at the ICU from this patient group at three time points (T1-3): T1: within 12 hours after admission; T2: second day morning; T3: third day morning of follow-up.
15725503|NCT05060679|Other|Sepsis-related acute kidney injury therapy|Patient management of sepsis and sepsis-related acute kidney injury followed the international guidelines of the 2016 Surviving Sepsis Campaign (SSC) regarding respiratory, antimicrobial, anticoagulation, vasopressor and hydrocortisone therapy, along with adequate fluid resuscitation, sedation, ulcer prophylaxis, nutrition and renal replacement therapy (if needed). In this patient group, blood sampling was performed at three time points (T1-3): T1: within 12 hours after admission; T2: second day morning; T3: third day morning of follow-up.
15725504|NCT05060666|Drug|Ivermectin|"2 doses of Ivermectin will be administered with 48 hours time interval.
~The dosage is based on body weight calculated as follows:
~15 mg for 40-60 kg = 5 tablets à 3 mg
~18 mg for 60-80 kg = 6 tablets à 3 mg
~24 mg for > 80 kg = 8 tablets à 3 mg each
~This corresponds to an ivermectin dose of about 300 µg / kg."
15725505|NCT05060666|Drug|Placebo|"An analogous number of tablets is administered for placebo:
~5 tablets for 40-60 kg
~6 tablets for 60-80 kg
~8 tablets for > 80 kg
~The size, appearance, smell and taste of the tablets of placebo are identical to Ivermectin."
15725506|NCT05060653|Other|SBRT followed by surgical stabilization within 24-48 hours|In a first step, patients will undergo SBRT with active sparing of the surgical site. Patients will receive high dose, single to few fractions radiotherapy consisting of a boost to the metastases exclusively. The bony compartment containing the metastatic lesion will receive an elective dose in order to treat subclinical disease. Treatment planning is performed on the pre-treatment CT and MRI data in radiotherapy position that are mutually registered to yield information on all relevant structures for planning. Dose constraints are set for the organ at risks based on institution specific guidelines. All patients will be treated with on online position verification protocol based on institution specific guidelines. Hereafter, surgical intervention will be performed to the standard of care.
15725507|NCT05060640|Procedure|Detection of anal HSIL in a routine colonoscopy.|Detection of anal HSIL in a routine colonoscopy by using acetic acid and NBI/BLI.
15725511|NCT05060614|Procedure|Hip fracture surgery|Hip fracture surgery
15725512|NCT05060601|Procedure|Gracey micro-curettes|Mechanical debridement will be performed by means of ultrasonic scalers with specific thin tips and micro-curettes, in order to minimize trauma for gingival tissues.
15725513|NCT05060601|Procedure|Standard Gracey curettes|After local anaesthesia, non surgical subgingival debridement will be performed by standard Gracey curettes
15725514|NCT05060588|Drug|Sacubitril/Valsartan 49/51mg/Tab|patients who meet the inclusion criteria are randomized to receive Sacubitril/Valsartan 24/26 mg once every 12 hours for 6 months
15725515|NCT05060588|Drug|Valsartan 80mg/Tab|Patients who meet the inclusion criteria are randomized to receive valsartan one tablet every 24 hours for 6 months.
15725516|NCT05060575|Other|Education and Telephone Counceling|"Drug use and rational drug use training will be given to hypertension patients in the experimental group.
~The patients in the experimental group twice in the 1st month (2nd and 4th weeks), once in the 2nd month (8th week) and once in the 3rd month (12th week) phone call counseling will be providedved an average of 10-15 minutes."
15725519|NCT05060549|Drug|Cariprazine|Participants will receive 6 weeks of cariprazine treatment
15725520|NCT05060536|Procedure|Removal of infrapatellar fat pad|"There is no agreed protocol for retaining or excising the infrapatellar fat pad with many surgeons routinely completely removing the fat pad to improve view of the proximal tibia while others opt to retain or minimally excise the tissue.
~We are aware of no risks involved in performing this procedure and current practice of many orthopaedic surgeons is either to routinely remove or routinely retain the infrapatellar fat pad when performing total knee arthroplasty.
~The potential benefits are that we will understand better whether removing or retaining this tissue does have a role in influencing outcomes after total knee replacement surgery. The results will be disseminated to the wider orthopaedic community to inform practice with the aim or improving outcomes from total knee arthroplasty."
15725521|NCT05060536|Procedure|No removal of infrapatellar fat pad|Retaining the infrapatellar fat pad during total knee replacement- no surgical removal.
15725522|NCT05060523|Drug|Tolvaptan Tablets|• Tolvaptan15 mg once a day for 7 days, stat with 7.5 mg and titrate to 15 mg in 24 hours max30 mg
15725523|NCT05060523|Drug|Midodrine Oral Tablet|"• Midodrine 5 mg at 0 hours and then 5 mg every 8 hours to maintain Target MAP-80"
15725525|NCT05060510|Diagnostic Test|Take home saliva kit|Saliva kits will be made available at schools for pick up to support symptomatic testing using PCR for students, staff and family members.
15725530|NCT05060471|Drug|Toripalimab|Four cycles of neoadjuvant PD-1 antibody toripalimab combined with docetaxol and cisplatin, followed by radiotherapy and two cycles of concurrent toripalimab.
15725531|NCT05060458|Other|No intervention|No intervention
15725532|NCT05060432|Drug|EOS-448|Anti-TIGIT monoclonal antibody
15725533|NCT05060432|Drug|Anti-PD1|Anti-PD-1 monoclonal antibody
15725534|NCT05060432|Drug|inupadenant|A2A receptor antagonist
15725535|NCT05060419|Drug|Meropenem- FL058|"Meropenem-FL058(Meropenem 1000mg plus FL058 1000mg)q8h
~Meropenem-FL058(Meropenem 2000mg plus FL058 1000mg)q8h"
15725536|NCT05060419|Drug|Piperacillin -tazobactam|Piperacillin-tazobactam (piperacillin 4 g plus tazobactam 0.5 g)q8h
15725537|NCT05060419|Drug|Saline|180min
15725538|NCT05060419|Drug|Saline|30min
15725539|NCT05060406|Drug|LY06006|60 mg/1 ml, once every 6 months administered subcutaneously, two injections in total
15725540|NCT05060393|Behavioral|Mindfulness-based cognitive therapy|Mobile application, mindfulness-based therapy
15725541|NCT05060380|Other|Exercise training|Progressive muscle resistive exercise will be performed by the experimental group only. Control group will maintain their normal level of daily activity.
15725542|NCT05060367|Dietary Supplement|Liposomal multivitamin/mineral|Two-capsule dose of liposomal multivitamin/mineral that is nutrient-matched to the standard multivitamin/mineral.
15725543|NCT05060367|Dietary Supplement|Standard multivitamin/mineral|Two-capsule dose of standard multivitamin/mineral that is nutrient-matched to the liposomal multivitamin/mineral.
15725544|NCT05060354|Other|Blood draw|Approximately 120 mL whole blood will be collected from each subject at each timepoint
15725545|NCT05060328|Other|Medical Device Usage and Evaluation|"Use Google Translate Conversation Mode translation application."
15725546|NCT05060328|Other|Survey Administration|Complete survey
15725547|NCT05060315|Combination Product|Remunity Pump for Remodulin|Participants on the study will receive Remodulin via the Remunity Pump with dosing and titration managed at the discretion of the prescribing healthcare professional. Dosing and titration of Remodulin will in no way be influenced by the participation in this study or this protocol.
15725548|NCT05060302|Other|transthoracic echocardiography (TTE)|the included patients have a TTE preoperatively in order to evaluate the RV systolic function. TTE will also be done at day 2 and day-15 during the follow-up surgical consultation.
15725549|NCT05060276|Biological|STI-3258|Intravenous infusion of STI-3258 will be given (one infusion every three weeks).
15725550|NCT05060263|Drug|HOT-1030|HOT-1030 is a Recombinant Humanized CD137 Monoclonal Antibody Injection
15725551|NCT05060237|Combination Product|BF-200 ALA and red light LED lamp|"Photodynamic therapy (PDT) using BF-RhodoLED® XL (ALA-PDT, Ameluz®-PDT):
~Topical application of 3 tubes BF-200 ALA on the expanded treatment field (60 cm²), followed by red light illumination with BF-RhodoLED® XL after 3 h incubation of study medication under light-tight, occlusive dressing."
15725552|NCT05060224|Device|EasyLaser: Low Level Laser therapy|
15725553|NCT05060211|Other|Vancouver symptom score for dysfunctional elimination syndroms|Validated questionnaire concerning bladder and bowel symptoms
15725554|NCT05060211|Other|Magnetic resonance imaging|Known MRI results of the patient file
15725555|NCT05060198|Drug|Artemether-lumefantrine (AL)|AL is the current first-line antimalarial in Kenya, per Kenya Ministry of Health.
15725556|NCT05060198|Drug|Dihydroartemisinin-piperaquine (DP)|DP is the current second-line antimalarial in Kenya, per Kenya Ministry of Health.
15725557|NCT05060185|Device|the Flow Diverter|Those who meet the inclusion criteria but do not meet the exclusion criteria will be enrolled through the electronic central registration system. The investigator log in to the central registration system, fill in the subject information and submit it who enroll in the study. The investigator complete the surgery and conduct relevant evaluation according to the protocol.
15725558|NCT05060172|Device|Bloomlife NST|"Bloomlife NST is a non-invasive, wireless, external monitoring system used to measure fetal heart rate, maternal heart rate, and uterine activity during antepartum (non-stress) testing on pregnant women with a singleton pregnancy.
~The system acquires biopotential signals from abdominal surface electrodes and measures the fetal electrocardiography, maternal electrocardiography and electrohysterography."
15725559|NCT05060159|Other|Hemofiltration|Postdilutional Hemofiltration
15725560|NCT05060146|Other|Structured medico-pharmaceutical collaboration|Reconciliation of drug treatments; Writing of the prescription for discharge from hospital for the pneumococcal vaccine; Pharmaceutical interview at discharge; Drafting of the discharge letter and transmission to the attending physician; Writing of the pharmaceutical discharge letter and transmission to the pharmacist; Pharmaceutical dispensing in the pharmacy; Administration of the vaccine by the attending physician or a nurse at home.
15725562|NCT05060120|Diagnostic Test|biomakers for ovarian torsion|Blood biomarkers analysis using multiplex ELISA: The Luminex system is a magnetic bead-based multiplex ELISA that enable to measure simultaneously multiple proteins within the same sample. Human magnetic Luminex assay will be used for the following analytes: D-Dimer (21.7-5,280 ng/ml), FABP4/A-FABP (0.637-155 ng/ml), GM-CSF (0.012-2.98 ng/ml), ICAM-1/CD54 (6.9-1674 ng/ml), IFN-γ (0.058-14.2 ng/ml), IL-1α (0.005-1.27 ng/ml), IL-6 (0.005-1.2 ng/ml), IL-10 (0.005-1.2 ng/ml), IL-17/IL-17A (0.012-3.1 ng/ml), Park7/DJ-1 (0.26- 63.1 ng/ml), TNF-α (0.01-2.4 ng/ml), TSLP (0.003-0.7 ng/ml), VCAM-1/CD106 (7.8-1891 ng/ml) and VEGF (0.008-2.4 ng/ml). Plasma samples stored at -70°C will be sent to accredited lab at BioTest (Israel) for performing the multiplex ELISA readout assay test using MagPix system.
15725588|NCT05059912|Biological|Humanized CD7 CAR-T cells|Patients will receive infusion of CAR T-cells targeting CD7 to confirm the safety and efficacy of CD7 CAR T-Cells in CD7+ relapsed or refractory T cell lymphoma
15725676|NCT05059184|Other|This is an observational cross-sectional study, there is no need for intervention|This is an observational cross-sectional study. There is no need for intervention
15725563|NCT05060120|Diagnostic Test|peritoneal fluid proteins analysis|"Western blot for peritoneal fluid proteins analysis
~We will look for the relative abundance of proteins involved in the protection of cells against oxidative stress and the regulation of reactive oxygen species (ROS) using western blot. Superoxide dismutase 1 (SOD1, 16kDa) scavenges superoxides (O-2) within cells. Catalase (60kDa) is hydrogen peroxide (H2O2) scavenging enzyme regulate ROS concentrations within cells by reducing H202 into O2 and water. Thioredoxin (12kDa) facilitates the reduction of proteins via cysteine thiol-disulfide exchange. Alpha smooth muscle actin (42kDa) will be used as a loading control. These four proteins will be resolved by western blot given their different molecular weights using western blot cocktail antibodies (abcam # ab179843)."
15725564|NCT05060107|Biological|Exosomes (sEVs)|Exosomes 3-5x10e11 particles/dose
15725565|NCT05060081|Other|Pilates exercise program group|Pilates exercise program group will do a warm-up for 10 minutes and then perform five exercises includes standing footwork, hundreds with knee straight, articulating bridge, rolling like a ball, plank for 25 minutes. For first three weeks, each player will do 8 repetitions × 3 sets of exercises and for next three weeks, each player will do 15 repetitions × 3 sets of exercises. There will be cool-down for 10 minutes after exercises. Total program will be of 45 minutes.
15725566|NCT05060081|Other|Traditional plank exercise program group|Traditional plank exercise program group will do a warm-up for 10 minutes and then perform five exercises includes prone bridge, side bridge, supine bridge on exercise ball, prone bridge on exercise ball, superman on exercise ball. For first three weeks, each player will do 8 repetitions × 3 sets of exercises and for next three weeks, each player will do 15 repetitions × 3 sets of exercises. There will be cool-down for 10 minutes after exercises. Total program will be of 45 minutes.
15725567|NCT05060068|Drug|S-ketamine (low dose)|Patients in the low-dose ketamine group will receive a bolus of 0.5 mg/kg S-ketamine in saline, followed by continuous infusion of 2 μg/kg/min S-ketamine in saline until 30 min prior to the end of the surgery.
15725568|NCT05060068|Drug|Placebo|Patients in the placebo group will receive a bolus of 0.9% saline, followed by continuous infusion of 0.9% saline until 30 min prior to the end of the surgery.
15725569|NCT05060068|Drug|S-ketamine (high dose)|Patients in the high-dose ketamine group will receive a bolus of 0.5 mg/kg S-ketamine in saline, followed by continuous infusion of 4 μg/kg/min S-ketamine in saline until 30 min prior to the end of the surgery.
15725570|NCT05060055|Procedure|Immediate dental implant placement|Immediate dental implant placement
15725575|NCT05060016|Drug|AMG 757|Intravenous (IV) infusion
15725576|NCT05060003|Drug|Atezolizumab|Atezolizumab is provided by Genentech.
15725577|NCT05060003|Drug|Tiragolumab|Tiragolumab is provided by Genentech.
15725578|NCT05060003|Procedure|ctDNA|Pre-screening/baseline (4-12 weeks after date of surgery), cycle 3 day 1, cycle 6 day 1, cycle 9 day 1, cycle 12 day 1, and end of treatment (optional)
15725579|NCT05059990|Other|Low Intensity Aerobic Exercises Group|Intervention Low Intensity Aerobic Exercises i.e. stationary cycle(supervised) Intensity 55-65% of HRmax Frequency 3 times a week Duration 30 min each session
15725580|NCT05059990|Other|Active Exercises Group|Intervention Upper and lower limb ROM & stretching exercises Intensity As per tolerance Frequency 12 repetition/4sets per exercise 3 times/week Duration 30 minutes each session
15725581|NCT05059977|Biological|TAK-881|Participants will receive subcutaneous infusion of TAK-881 on Day 1.
15725582|NCT05059964|Other|Circuit Training program|"The 4 weeks Circuit Training program, it will be of 3 times per week. Each CT workout includes 6 stations per circuit Training. Before the training period, all participants underwent an exercise familiarization session to ensure proper execution of technique.
~The 6 stations will be included as 40 lb. carry for 100 ft., 3-min stair climb, 45 s plank pose, 20 lb. carry with a fast walk for 100 ft., right and left single leg stands for as long as balance was maintained, and a 15 lb. carry up and down 30 stairs"
15725583|NCT05059964|Other|Continuous aerobic exercise Group|Continuous aerobic exercise Frequency 3 time per week Intensity 50% of Heart rate reserve Type continuous aerobic exercise Time 40 minutes
15725584|NCT05059951|Drug|immune checkpoint inhibitor-combined|Pembrolizumab and Sintilimab
15725585|NCT05059938|Behavioral|MyFitnessPal user|Patients will be counseled on how to use the MyFitnessPal application to help with the patient's weight loss goals. The physician will monitor the patient's weight, blood pressure, and waist circumference over up to a six month period with visits at 1, 3, and 6 months. Patients will be asked about the patient's use of the application at the end of the study.
15725586|NCT05059925|Other|Structured gym activities|"Planned and structured activities such as Strength training
~Dumbbell Exercises (1kg with 2 sets of 10 repetitions)
~Sit-ups (2 sets of 10 repetitions)
~Stair climbing, (2 sets of 10 stairs up and down)
~Squat (2 sets of 10 repetitions) Flexibility training • Tai chi (Peng. Lu, chi, an Tsai, lieh, chou, Kao (Hold each posture for 20 seconds)) • Pilates (Breathing., Shoulder bridge, Leg lifts (Hold each pose for 20 seconds)) • Stretching techniques (Neck stretch, Shoulder stretch, Side stretch Hold each stretch for 20 seconds))."
15725587|NCT05059925|Other|Traditional aerobic activities|"Activities performed such as
~Treadmill Time: 10 minutes Intensity: 60 to 80% of target heart rate
~Cycle ergometer Time: 10 minutes Intensity: 60 to 80% of target heart rate
~Elliptical exercises Time: 10 minutes Intensity: 60 to 80% of target heart rate"
15725638|NCT05059522|Drug|PF04518600|IV infusion
15725590|NCT05059886|Other|completion of a questionnaire on the practice of sports and possible injuries|completion of a questionnaire on the practice of sports and possible injuries
15725593|NCT05059860|Device|Tandem Control IQ Hybrid Closed Loop Insulin Delivery System|The Tandem Control IQ hybrid closed loop insulin delivery system is made up of an externally worn Tandem insulin pump which communicates wirelessly to the Dexcom G6 CGM worn as a patch on the skin. The CGM measures glucose levels transmitting them into the computer within the pump. The computer then calculates how much insulin is required then dose delivery completes the cycle. The Control-IQ™ advanced technology adjusts insulin delivery to avoid glycaemic excursions, while still allowing the user to manually bolus at mealtimes.
15725594|NCT05059847|Other|Training|Training routine assigned by randomized chart
15725597|NCT05059821|Biological|Peptide cancer vaccine|Vaccine content are personalized peptides vaccine separated from each patients own tumor cells, autologous heat shock protein 70 separated from tumor cells and autologous activated monocytes that administered subcutaneously monthly for six months
15725598|NCT05059782|Drug|chemotherapy, targeted therapeutics, immunotherapy|Chemotherapy drugs ,targeted drugs or Immune checkpoint inhibitors are taken throughout the body or a combination of these drugs according to clinical needs is performed when necessary.
15725599|NCT05059782|Radiation|IFRT, IMRT or SBRT|IFRT（involving field radiotherapy） IMRT （ intensity modulated radiation therapy） SBRT （stereotactic body radiation therapy）
15725600|NCT05059756|Device|PTNS|PTNS and PFR
15725601|NCT05059756|Device|Sham PTNS|Sham PTNS and PFR
15725602|NCT05059743|Drug|[14C]-Larotinib|Patients will receive single dose of orally [14C]-Larotinib on Day 1.
15725603|NCT05059730|Other|Zero Degrees Cold Environment|Participants will be exposed to zero degrees celsius environment.
15725604|NCT05059730|Other|Eight Degrees Cold Environment|Participants will be exposed to eight degrees celsius environment.
15725605|NCT05059730|Other|Ten Degrees Cold Environment|Participants will be exposed to Ten degrees celsius environment.
15725606|NCT05059730|Other|40 degrees Hot Environment|Participants will be exposed to 40 degrees celsius hot environment.
15725607|NCT05059717|Procedure|Magnetic Resonance Imaging|Undergo standard of care MRI
15725608|NCT05059717|Procedure|Magnetic Resonance Imaging|Undergo MR DENSE imaging
15725609|NCT05059704|Other|Circuit Class Training|Station 1 will include tasks for warm-up specific for upper extremity, station 2 will include shoulder exercises, station 3 will include elbow exercises, station 4 will include wrist exercises and station 5 will include hand activities and functional training. Variables such as speed, or/and resistance will progressively increase in diﬃculty according to each patient's ability.
15725610|NCT05059704|Other|Individual Task specific training|Variables such as speed, or/and resistance will progressively increase in diﬃculty according to each patient's ability.
15725611|NCT05059691|Other|Electronic Health Record Review|Review of medical records
15725612|NCT05059691|Procedure|Transbronchial Cryobiopsy Guided by Three-Dimensional Fluoroscopy|Undergo transbronchial cryobiopsy guided by three-dimensional fluoroscopy
15725613|NCT05059678|Other|Best Practice|Receive standard of care
15725614|NCT05059678|Other|Educational Intervention|Receive educational materials and attend videoconference sessions
15725615|NCT05059678|Other|Questionnaire Administration|Ancillary studies
15725617|NCT05059652|Device|Ischemic Preconditioning|The Ischemic Preconditioning (IPC) is characterized by the application of brief periods of circulatory occlusion (ischemia) and reperfusion of a limb in the minutes to hours that precede the exercise through the insufflations and deflations of a pressure cuff.
15725618|NCT05059639|Other|Almond|Consume 2 ounces of almond daily for 8 weeks
15725619|NCT05059639|Other|Pretzel|Consume comparative amount of pretzel daily for 8 weeks
15725620|NCT05059626|Drug|simvastatin 10mg|Simvastation acts as a systemic LOX inhibitor.
15725621|NCT05059626|Drug|Bazedoxifene 20/Estrogens,Con 0.45Mg Tb|Duavee is a selective estrogen receptor modulator.
15725622|NCT05059626|Drug|Placebo|Placebo for statin and SERM pretreatments.
15725623|NCT05059613|Other|probiotics|one times a day during the whole treatment
15725624|NCT05059600|Drug|ZULRESSO®|Intravenous infusion of ZULRESSO®.
15725625|NCT05059587|Drug|MBA-P01|MBA-P01 will be injected into the Glabellar line.
15725626|NCT05059587|Drug|BOTOX|Botox will be injected into the Glabellar line.
15725627|NCT05059574|Behavioral|Breast Crawling|The mother's first breast-feeding of her baby is not routine biological breast-feeding, but as a cradle to the breast.
15725628|NCT05059561|Radiation|X-ray radiograghy|Cobb angles of the patient and control groups were determined by using X-Ray radiography used in the radiological examination routinely applied to the individuals who applied for the health board examination.
15725629|NCT05059548|Other|Video-Assisted Thoracoscopic Surgery|patients receive Video-Assisted Thoracoscopic Surgery under general anesthesia
15725630|NCT05059535|Drug|standard pain relievers|Knee arthroscopy will be performed ansd patients will receive standard pain relievers in confomtity with the current practice
15725631|NCT05059522|Drug|Avelumab|oral
15725632|NCT05059522|Drug|Lorlatanib|oral
15725633|NCT05059522|Drug|Talazoparib|oral
15725634|NCT05059522|Drug|Pemetrexed|IV (intravenous) infusion
15725635|NCT05059522|Drug|Axitinib|oral
15725636|NCT05059522|Drug|CMP 001|IT (intratumoral) or SC (subcutaneous)
15725637|NCT05059522|Drug|Utomilumab|IV infusion
15725640|NCT05059496|Other|Hamstring stretching with Pressure Biofeedback Unit|Hot Pack 15 mins/1 set/ (3 days/week), Hamstring stretching with Pressure Biofeedback Unit 30 secs hold/ 15 secs rest/ 3 sets/ (3 days/week), TENS 15 mins/ 1 set/ (3 days/week). A total of 4 weeks (12 sessions, 3 days/ week) were given each consisting of 35 mins.
15725641|NCT05059496|Other|Hamstring stretching with out Pressure Biofeedback Unit|Hot Pack 15 mins/1 set/ (3 days/week), Hamstring stretching without Pressure Biofeedback Unit 30 secs hold/ 15 secs rest/ 3 sets/ (3 days/week), TENS 15 mins/ 1 set/ (3 days/week). A total of 4 weeks (12 sessions, 3 days/ week) were given each consisting of 35 mins.
15725642|NCT05059470|Drug|Pembrolizumab|Given by IV
15725643|NCT05059457|Device|Blood source: single and pooled capillary and venous blood|"A single drop of capillary blood (blood drop #3) will be placed in a microcuvette directly from a finger/heel and tested using a HemoCue 201+.
~Pooled capillary blood will be placed in a Microtainer® tube (250-500 µL) containing EDTA and then a drop of blood placed in a microcuvette and tested using a HemoCue 201+.
~Venous blood will be collected into a 3mL Vacutainer tube containing EDTA and then a drop of blood will be placed in a microcuvette and tested using a HemoCue 201+ and autoanalyzer."
15725644|NCT05059457|Device|Blood source: single capillary and venous blood|"A single drop of capillary blood (blood drop #3) will be placed in a microcuvette directly from a finger/heel and tested using a HemoCue 201+ .
~Venous blood will be collected into a 3mL Vacutainer tube containing EDTA and then a drop of blood will be placed in a microcuvette and tested using a HemoCue 201+ and autoanalyzer."
15725645|NCT05059457|Device|Blood source: pooled capillary and venous blood|"Pooled capillary blood will be placed in a Microtainer® tube (250-500 µL) containing EDTA and then a drop of blood placed in a microcuvette and tested using a HemoCue 201+.
~Venous blood will be collected into a 3mL Vacutainer tube containing EDTA and then a drop of blood will be placed in a microcuvette and tested using a HemoCue 201+ and autoanalyzer."
15725646|NCT05059444|Diagnostic Test|Guardant Reveal|Guardant Reveal is a minimal residual disease (MRD) panel for use in recurrence detection of early-stage solid tumors.
15725647|NCT05059418|Drug|Clonazepam 0.5 MG|Topical treatment of oral mucosa with lozenge pill
15725648|NCT05059418|Drug|Capsaicin Topical|Topical treatment of oral mucosa with capsaicin rinse
15725649|NCT05059418|Other|Placebo|Mouth rinse with no capsaicin
15725650|NCT05059392|Behavioral|Training for Awareness, Resilience and Action (TARA)|See arm description
15725653|NCT05059366|Device|Manual Ventilation Grip Device|Manual Ventilation Grip Device is an add-on device placed on a standard valve mask to assist ventilation.
15725654|NCT05059366|Other|2VE|the standard 2VE technique for ventilation
15725655|NCT05059353|Device|Digitally based multidomain intervention|"Education (5-10 mins). This session is to educate patients on instrumental activities of daily living such as the importance of companionship, medication, finance, home, travel, and kitchen safety. The content will be delivered using video and text-based material in English.
~Physical Activity (10 mins). This session includes activities such as brisk walking and yoga. Participants will be allowed to choose their preferred exercise option from the menu.
~Reminiscence Therapy (20 mins). This session includes recollection of events using directed questions, and a collection of photos from the past. Participants will be asked to share about any aspect related to the given topics using text or audio.
~Cognitive Games (20 mins). Participants will be asked to play games using their fingers to control characters on the screen to achieve goals. These games are designed to train different cognitive abilities, including attention, memory, executive functioning, and processing speed."
15725656|NCT05059327|Drug|Basimglurant with crossover to Placebo|Basimglurant with crossover to Placebo
15725657|NCT05059327|Drug|Placebo with crossover to Basimglurant|Placebo with crossover to Basimglurant
15725658|NCT05059314|Other|Brisk walking (moderate physical activity)|"Warm up and cool down
~Brisk walk (30 mintues each session per week 5 days)
~Week 1 to 6"
15725660|NCT05059288|Device|Investigational Non Invasive Ventilation Mask|Oronasal non invasive ventilation mask
15725661|NCT05059275|Procedure|modified ostium obstruction surgery|An ostium at the end of the site where the nerve root enters the dural sac, from which CSF could flow continuously along the subarachnoid space, was identified An appropriate amount of autologous soft adipose tissue was removed under the skin of the incision or deep in the upper part of the buttock (Iliac spine incision, for less subcutaneous fat patients). It was then trimmed to resemble a gourd or dumbbell, with a relatively small middle section and two relatively large end sections. Trimmed graft was inserted into the neck of the sac and subarachnoid space below the dural sac so that it plugs the ostium inside and outside After filling the graft, Prolene 6-0 was used to continuously suture and close the ostium and dural sac starting from the lower part of the nerve root sheath and the ostium.The residual cyst cavity filled with autologous fat and gelatin sponge
15725662|NCT05059262|Drug|vimseltinib|CSF1R inhibitor
15725663|NCT05059262|Drug|Placebo|Placebo
15725664|NCT05059249|Procedure|Hot Pack|Superficial Heating
15725665|NCT05059249|Procedure|Manual Traction|Manual Traction for 10 minutes
15725666|NCT05059249|Procedure|Mechanical Traction|Mechanical Traction for 10 minutes
15725667|NCT05059249|Procedure|Joint Mobilization|3 sets of slow gentle segmental mobilizations (unilateral and posterior-anterior) with at least 10 to 15 repetitions
15725668|NCT05059249|Procedure|TENS|TENS for 10 minutes with hot pack
15725671|NCT05059223|Drug|AXS-12 (reboxetine)|AXS-12 tablets, taken twice daily
15725672|NCT05059223|Drug|Placebo|Placebo tablets, taken twice daily
15725679|NCT05059158|Radiation|positron emission tomography (PET)|18-Flutemetamol PET (clinical indicated) is going to be performed at the visit.
15725680|NCT05059145|Drug|Chlorhexidine Gluconate|Vaginal cream 1%
15725681|NCT05059145|Drug|Fluconazole|150 mg oral capsule
15725682|NCT05059132|Behavioral|Tele-rehabilitation|The tele-rehabilitation intervention will include education, inspiratory muscle training, and behavioral support to promote walking.
15725683|NCT05059132|Other|Education only|The education only arm will receive information on the importance of general exercise following lung cancer treatment.
15725684|NCT05059106|Biological|Half dose of ChAdOx1 nCoV-19 (AZD1222)|Vaccination with reduced dose (half dose) of ChAdOx1 nCoV-19 (AZD1222), in a 2-dose schedule with an interval of 8 weeks, including all adults aged 18 to 49 years, from non-priority groups, from Viana city - Espírito Santo (ES)/Brazil.
15725685|NCT05059106|Biological|Standard dose of ChAdOx1 nCoV-19 (AZD1222)|Vaccination with standad dose of ChAdOx1 nCoV-19 (AZD1222), in a 2-dose schedule with an interval of 8 weeks, in external cohort of health workers aged 18 to 49 years.
15725686|NCT05059093|Diagnostic Test|Classification and segmentation deep learning models|Models that will be trained on retrospectively acquired data and run on the prospectively acquired data to extract biometric parameters and amniotic volume estimation.
15725687|NCT05059067|Device|Direct laryngoscopy for endotracheal intubation|Patients in operative room, intensive care unit and emergency department requiring direct laryngoscopy for endotracheal intubation
15725688|NCT05059054|Other|Strengthening exercise|"Strengthening exercise program Participants performed this protocol at home for 3 times per day. The participants progress their exercise based on the achievement of the previous level of each exercise protocol. The physical therapist recorded the level of each exercise for each participant during eight times of treatment. Total time for this section is approximately 30 minutes. Detail of the strengthening exercise is in the following.
~Toe curl exercise (toe flexors strengthening)
~Ankle evertor exercise (peroneal strengthening)
~Ankle invertor exercise (tibialis posterior strengthening)
~Heel raise exercise (high-load strength training)"
15725689|NCT05059054|Other|Insole (CFO) group|"The CFO insole group The participants will receive the foot assessment before making the CFO for each participant. The 3-quarter-length CFO will be made from thermoplastic material (rigid foot orthoses) which consists of four layers i.e. two layers of 0.5-mm polyvinyl chloride (PVC) and one layer of 1.5-mm thick fiber to increase strength of foot orthoses in the bottom layers as well as one layer of 1.2-mm genuine leather in the upper layer to increase comfort.
~The participants will be asked to use the CFO in daily life during weight-bearing activities."
15725690|NCT05059041|Device|Dilated Refraction|The dilated refraction will be a trial spectacle frame composed of lenses based upon a spectacle prescription determined from dilated measures of the eye using a wavefront aberrometer.
15725691|NCT05059041|Device|Non-Dilated Refraction|The non-dilated refraction will be a trial spectacle frame composed of lenses based upon a spectacle prescription determined from non-dilated measures of the eye using a wavefront aberrometer.
15725692|NCT05059028|Other|Oxytocin massage AND music therapy|"Oxytocin massage: It is a massage that will accelerate the work of the parasympathetic nerves in order to transmit the oxytocin production stimulus to the posterior lobe of the brain. Massage the scapula from the cervical 7th to the 5th-6th spine, spinal (vertebral), 1-2 cm around the spine, both thumbs up and then 2-3 times down, in a small circular clockwise, downward and upward movements. It is a form of massage by pressing hard.
~Music intervention: In order to decide on the type of music to be played to the mothers during breastfeeding, three samples (Pentatonic, Büzürk makam and classical music) selected by the researcher will be asked to the postpartum mother, and the music preferred by the mothers will be determined. It will be ensured that mothers listen to the music determined 5 minutes before the breastfeeding session for 7 days and continue breastfeeding while the same music is playing."
15725693|NCT05059015|Diagnostic Test|CERVICAL HPV|A screening test with an HPV test is performed by a health professional plus cytology taking, if it reports positive, colposcopy and biopsy are taken, those with a CIN2 + report are directed to receive treatment.
15725694|NCT05059015|Diagnostic Test|SELF SAMPLING HPV|A screening test is performed with an HPV test by self-testing, if it reports positive, colposcopy and biopsy are taken, those with a CIN2 + report are directed to receive treatment.
15725695|NCT05058989|Diagnostic Test|Advanced ultrasound measurements (Duplex ultrasound (DUS) and Vector flow imaging (VFI)|PPG is a non-invasive method used to evaluates the severity venous reflux by measuring the venous refiling time (VRT).The principal of PPG works by using a small light source and a photoelectric cell attached to the skin in the medial supramalleolar area of the leg (the distal lower medial area of the leg).
15725696|NCT05058989|Other|Clinical interventions and procedures|"First trimester (0-13 weeks):
~Consent
~Clinical data collection
~Blood samples (genomic+ hormonal)
~Duplex ultrasound
~Vector flow imaging (advanced ultrasound software)
~Truncated cone tool (measuring leg circumference using a tape measure)
~PPG
~AVVQ (Aberdeen varicose veins questionaire)
~Second trimester (14-26 weeks):
~Clinical data collection
~Blood sample (hormonal only)
~DUS
~VFI
~Truncated cone tool
~PPG
~AVVQ
~Third trimester (27-40 weeks):
~Same as second trimester
~Three months after giving birth:
~Same as second trimester"
15725697|NCT05058976|Drug|Romosozumab|Monthly dose: 210 mg subcutaneous injection
15725698|NCT05058976|Drug|Placebo|Monthly saline injection
15725699|NCT05058976|Drug|Zoledronic acid|5 mg IV infusion at Month 12 Visit
15725700|NCT05058976|Dietary Supplement|Calcium and Vitamin D|Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
15725701|NCT05058963|Behavioral|Mantram repetition program|"Week 1: Define and describe the characteristics of a mantram as taught by Eknath Easwaran and how it relates to posttraumatic stress (PTSD) Week 2: Identify ways to choose and use mantram repetition for training attention and targeting craving.
~Introduction to substance craving and identify triggers for use. Week 3: Describe the relationship between the PTSD/stress response, mantram repetition and the relaxation response Week 4: Describe at least two benefits of slowing down versus automatic pilot for stress reduction Week 5: Describe at least two benefits of one-pointed attention versus multitasking for stress reduction Week 6: Demonstrate how one-pointed attention and slowing down complement each other for making healthy choices Week 7: List at least five strategies for making mantram repetition a part of your life Week 8: Discuss applications of mantram repetition, one-pointed attention and slowing down for overall health and substance use"
15725702|NCT05058937|Diagnostic Test|Comprehensive genomic profiling|TSO500 (523 genes + MTB + MSI)
15725703|NCT05058924|Drug|Prophylactic low molecular weight heparin|Enoxaparin 40 mg/dalteparin 5000 U/tinzaparin 4500 U subcutaneously daily for women with weight <100 kg for 6 weeks.
15725704|NCT05058924|Drug|Low molecular weight heparin and low-dose aspirin|Enoxaparin 40 mg/dalteparin 5000 U/tinzaparin 4500 U subcutaneously daily for women with weight <100 kg for three weeks followed by ASA 81 mg orally daily for three weeks.
15725707|NCT05058898|Other|blood samples|5 mL
15725708|NCT05058898|Other|Scabs and pus samples|if available
15725711|NCT05058859|Drug|Dapagliflozin|Dapagliflozin is to lower blood sugar levels in adults with type 2 diabetes
15725717|NCT05058833|Diagnostic Test|Echocardiography|Echocardiographic grades of diastolic function was defined according to 2016 ASE/EACVI recommendations for the evaluation of LV diastolic function. Cardiac diastolic dysfunction was defined as elevated E/e'≥15.
15725718|NCT05058833|Diagnostic Test|Coronary flow reserve and index of microcirculatory dysfunction|Coronary microcirculatory dysfunction was defined as having both depressed CFR (≤2.0) and elevated IMR (≥23U).
15725725|NCT05058768|Diagnostic Test|The lungs causes and extrapulmonary factors|Acute lung injury due to internal and external pulmonary causes can be used as intervention items in this study, and intervention items can be excluded according to inclusion criteria and exclusion criteria.
15725726|NCT05058755|Drug|tislelizumab, azacytidine, lenalidomide|"tislelizumab, 200mg, iv, day 1, every 21 days.
~azacytidine, 75mg/m2, ih, days 1-7, every 21 days.
~lenalidomide, 25mg, po, days 1-14, every 21 days."
15725727|NCT05058755|Drug|tislelizumab, etoposide, pegaspargase|"tislelizumab, 200mg, iv, day 1, every 21 days.
~etoposide, 100mg, iv, days 1-3, every 21 days.
~pegaspargase, 2000U/m2, day 1, every 21 days"
15725728|NCT05058742|Device|AuriStim|Auricular vagal nerve Stimulator, which Targets the auricular branches of the vagal nerve
15725729|NCT05058716|Diagnostic Test|blood sample|weekly blood sample - coenzym q10 levels
15725763|NCT05058417|Drug|Placebo|participants will receive placebo for 8 consecutive weeks in addition to the standard therapy
15729017|NCT05032144|Drug|Placebo|Intravenous injection
15725730|NCT05058690|Diagnostic Test|Oral Glucose Tolerance Test|"Obtain blood sample for glucose assessment (time 0 sample). This may be obtained via venepuncture or after cannula insertion.
~Test a small sample using a near patient glucose testing meter. If the result on the glucose meter is greater than or equal to 11mmol/L, send the blood sample urgently to lab. If it is confirmed by biochemistry to be above 11mmol/L, there is no need to continue test.
~If the result is less than 11mmol/L on meter, give the patient the glucose solution to drink.
~Collect a further blood sample at 120 minutes.
~Send samples all together to laboratory for glucose measurement."
15725731|NCT05058677|Drug|aerosolized 2% lidocaine (20mg/ml)|The aerosolized solution to be used is 2% lidocaine (20 mg/ml) at a dose of 1.5 mg/kg with a maximum volume of 3 ml or adjusted to a volume of 3 ml with addition of NS solution.The aerosolized solution will be administered with an Aerogen ultrasonic nebulizer, which is standard of care for administering aerosolized solutions in our pediatric intensive care unit (PICU).After each treatment a 3-minute interval will be allowed prior to ETS and there will be a 4-6 hour wash out period between each treatment.
15725732|NCT05058677|Drug|instilled 0.9% sodium chloride (NS)|The instilled solution will be given with a standard 3-5 ml syringe.After each treatment a 3-minute interval will be allowed prior to ETS and there will be a 4-6 hour wash out period between each treatment.
15725733|NCT05058677|Drug|instilled 2% lidocaine solution|The instilled 2 % lidocaine solution used will be 1.5 mg/kg, with a max volume of 3 ml or adjusted to a volume of 3 ml with addition of NS solution.The instilled solution will be given with a standard 3-5 ml syringe.After each treatment a 3-minute interval will be allowed prior to ETS and there will be a 4-6 hour wash out period between each treatment.
15725734|NCT05058677|Procedure|Endotracheal Suctioning (ETS)|ETS will be performed in a single pass using a closed-system suctioning. Suction will be applied only on withdrawal of the catheter and fraction of inspired oxygen (FIO2) will remain at 100% for 60 seconds following suctioning and then returned to the preprocedural level (baseline).
15725743|NCT05058625|Device|Dry Needling plus normal volleyball training|Once the trigger point has been identified, we will use the Hong tecnique looking for a local spasm response
15725744|NCT05058625|Other|Control Group|Normal volleyball training
15725745|NCT05058612|Drug|Midodrine|10 mg PO/NG q8h
15725746|NCT05058612|Drug|Placebo|Microcrystalline cellulose PO/NG 18h
15725747|NCT05058599|Diagnostic Test|DM|A new technology based on 3D reconstruction and deep learning algorithm to irreversibly erase the biometric attributes whilst retaining the clinical attributes needed for diagnosis and management
15725748|NCT05058586|Other|The Effects of Aerobic Exercise Training on Cardiorespiratory Fitness, Functional Capacity, Balance and Ventricular Repolarization Indices in Stroke Patients|Seventy patients with history of stroke admitted to our center between July 2017 and January 2018. Subjects participated in the study were randomly assigned to anti-gravity treadmill training, underwater walking therapy and control group. We examined aerobic capacity of participants by using 6-minute walk test and cycle ergometer testing before starting the treatment along with one month follow up. Patient's balance examined by using the Berg Balance Scale (BBS).
15725749|NCT05058573|Other|Control group (n=22)|Control group will be received only medical treatment
15725750|NCT05058560|Drug|Tislelizumab|tislelizumab, 200 mg IV Q3W, up to one year.
15725751|NCT05058547|Device|SWEPPE|In the smartphone application SWEPPE the individual can create an action plan, perform daily registrations of health aspects, self-monitoring of health aspects and goals, have access to a library with evidence-based facts and a coach, and possibility to share information with the employer.
15725752|NCT05058534|Device|Multiline Neo®|Multiperfusion neonatal system
15725753|NCT05058508|Other|"Just Move Exercise"|"Subjects complete Just Move Exercises Five Times Per Week"
15725754|NCT05058508|Other|Standard of Care Exercise|Subjects exercise/move as tolerated
15725755|NCT05058495|Other|Mobile Lymphedema Self-Care Support Program|The Mobile Lymphedema Self-Care Support Program is composed of three section. First section includes the information about lymphedema and lymphedema self care. Second section includes the exercises videos which women can concurrently exercise with application and an alarm to remind to exercise. Last section is a social network form the women could chat and share anything with eachother. Patients will be told how to use the Mobile Lymphedema Self-Care Support Program and a contact number will be provided to ask questions about the program at any time.
15725756|NCT05058495|Other|standart lymphedema education|The control group will be received standart lymphedema education. The standart lymphedema education is an oral education that composed of informations about lymphedema and lymphedema self-care.
15725757|NCT05058482|Device|embolism|Cerebral arteriovenous malformation embolism
15725758|NCT05058469|Device|Tracheotomy|Tracheotomy in patients +/- antiplatelet therapy
15725759|NCT05058456|Device|Shockwave Medical Mini S Peripheral IVL Catheter|The Shockwave Medical Mini S Peripheral IVL Catheter is intended for lithotripsy-enhanced catheter dilatation of lesions, including calcified lesions found in the peripheral vasculature, such as the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. The Mini S IVL Catheter is not for use in the coronary or cerebral vasculature.
15725760|NCT05058443|Drug|Denosumab|denosumab subcutaneously /6 months twice a year
15725761|NCT05058430|Device|Electrical salivary stimulator system|SaliPen is an electrical salivary stimulator system, intended to electrically stimulate a relative increase in saliva production. It is an intraoral device indicated for use in patients with xerostomia (dry mouth).
15725762|NCT05058417|Drug|Empagliflozin 10 MG|participants will receive 10 mg Empagliflozin for 8 consecutive weeks in addition to the standard therapy
15725764|NCT05058404|Drug|Immunochemotherapy regimen: Rituximab-bendamustine (Arm A)|"Arm A (Standard arm):
~4 cycles of Rituximab-bendamustine Q28 (28-days cycles); Patients will undergo an early restaging after cycle 4: those with at least a stable disease will complete the induction treatment with 2 cycles of R-bendamustine Q28 + 2 cycles Q28 of rituximab;
~Both Arms:
~Whichever the regimen, in responding patients (Complete Remission CR, Partial Remission PR) at the end of induction a standard maintenance will follows (1 dose every 8 weeks for 2 years) with the same anti-CD20 Monoclonal Antibody (MoAb) used for induction.
~Patients in both arms with progressive disease at any time and patients in stable disease (SD) at the End Of Induction (EOI) shall be considered for salvage therapy at clinician discretion."
15725765|NCT05058404|Drug|Immunochemotherapy regimen: Rituximab-bendamustine (Arm B)|"Arm B (Experimental arm):
~4 cycles of Rituximab-bendamustine Q28 (28-days cycles);
~After cycle 4 patients will undergo an early restaging. Induction therapy shall be completed based on the response achieved and on the treatment chosen as below specified:
~if in CR: patients will receive no more chemotherapy but will complete induction with the MoAb only, in this case: 4 cycles of rituximab;
~if less than CR (PR, SD): the immunochemotherapy program will be completed as outlined for Arm A: 2 cycles of R-bendamustine Q28 + 2 cycles Q28 of rituximab;
~Both Arms:
~Whichever the regimen, in responding patients (CR, PR) at the end of induction a standard maintenance will follows (1 dose every 8 weeks for 2 years) with the same anti-CD20 Monoclonal Antibody (MoAb) used for induction.
~Patients in both arms with progressive disease at any time and patients in SD at the End Of Induction (EOI) shall be considered for salvage therapy at clinician discretion."
15725766|NCT05058404|Drug|Immunochemotherapy regimen: R-CHOP (Arm A)|"Arm A (Standard arm):
~4 cycles of R-CHOP Q21 (21-days cycles); R-CHOP = Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
~Patients will undergo an early restaging after cycle 4: those with at least a stable disease will complete the induction treatment with 2 cycles of R-CHOP Q21 + 2 cycles Q21 of rituximab;
~Both Arms:
~Whichever the regimen, in responding patients (Complete Remission CR, Partial Remission PR) at the end of induction a standard maintenance will follows (1 dose every 8 weeks for 2 years) with the same anti-CD20 Monoclonal Antibody (MoAb) used for induction.
~Patients in both arms with progressive disease at any time and patients in stable disease (SD) at the End Of Induction (EOI) shall be considered for salvage therapy at clinician discretion: these patients will be included in the analysis planned by the study."
15725767|NCT05058404|Drug|Immunochemotherapy regimen: R-CHOP (Arm B)|"Arm B (Experimental arm):
~4 cycles of R-CHOP Q21 (21-days cycles); R-CHOP = Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
~After cycle 4 patients will undergo an early restaging: induction therapy shall be completed based on the response achieved and on the treatment chosen:
~if in CR: patients will receive no more chemotherapy but will complete induction with the MoAb only, in this case: 4 cycles of rituximab;
~if less than CR (PR, SD): the immunochemotherapy program will be completed as outlined for Arm A: 2 cycles of R-CHOP Q21+ 2 cycles Q21of rituximab
~Both Arms: in responding patients (CR, PR) at the end of induction a standard maintenance will follows (1 dose every 8 weeks for 2 years) with the same anti-CD20 MoAb used for induction.
~Patients in both arms with progressive disease at any time and patients in SD at the EOI shall be considered for salvage therapy at clinician discretion: these patients will be included in the analysis."
15725768|NCT05058404|Drug|Immunochemotherapy regimen: G-bendamustine (Arm A)|"Arm A (Standard arm):
~4 cycles of G-bendamustine Q28 (28-days cycles); G-Bendamustine = Obinutuzumab and Bendamustine
~Patients will undergo an early restaging after cycle 4: those with at least a stable disease will complete the induction treatment with 2 cycles of G-bendamustine Q28 (28-days cycles);
~Both Arms:
~Whichever the regimen, in responding patients (Complete Remission CR, Partial Remission) at the end of induction a standard maintenance will follows (1 dose every 8 weeks for 2 years) with the same anti-CD20 Monoclonal Antibody (MoAb) used for induction.
~Patients in both arms with progressive disease at any time and patients in Stable Disease SD at the End Of Induction (EOI) shall be considered for salvage therapy at clinician discretion."
15725769|NCT05058404|Drug|Immunochemotherapy regimen: G-bendamustine (Arm B)|"Arm B (Experimental arm):
~4 cycles of G-bendamustine Q28 (28-days cycles); G-Bendamustine = Obinutuzumab and Bendamustine
~After cycle 4 patients will undergo an early restaging. Induction therapy shall be completed based on the response achieved and on the treatment chosen as below specified:
~if in CR: patients will receive no more chemotherapy but will complete induction with the Monoclonal Antibody (MoAb) only, in this case 2 cycles of obinutuzumab;
~if less than CR (PR, SD): the immunochemotherapy program will be completed as outlined for Arm A: 2 cycles of G-bendamustine Q28;
~Both Arms: in responding patients (CR, PR) at the end of induction a standard maintenance will follows (1 dose every 8 weeks for 2 years) with the same anti-CD20 (MoAb) used for induction.
~Patients in both arms with progressive disease at any time and patients in SD at the End Of Induction (EOI) shall be considered for salvage therapy at clinician discretion."
15725770|NCT05058404|Drug|Immunochemotherapy regimen: G-CHOP (Arm A)|"Arm A (Standard arm):
~4 cycles of G-CHOP Q21 (21-days cycles) G-CHOP = Obinutuzumab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
~Patients will undergo an early restaging after cycle 4: those with at least a stable disease will complete the induction treatment with 2 cycles of G-CHOP Q21 + 2 cycles Q21 of obinutuzumab;
~Both Arms:
~Whichever the regimen, in responding patients (Complete Remission CR, Partial Remission PR) at the end of induction a standard maintenance will follows (1 dose every 8 weeks for 2 years) with the same anti-CD20 Monoclonal Antibody (MoAb) used for induction.
~Patients in both arms with progressive disease at any time and patients in stable disease (SD) at the End Of Induction (EOI) shall be considered for salvage therapy at clinician discretion."
15725771|NCT05058404|Drug|Immunochemotherapy regimen: G-CHOP (Arm B)|"4 cycles of G-CHOP Q21 (21-days cycles) G-CHOP = Obinutuzumab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone
~After cycle 4 patients will undergo an early restaging. Induction therapy shall be completed based on the response achieved and on the treatment chosen as below specified:
~if in CR: patients will receive no more chemotherapy but will complete induction with the Monoclonal Antibody (MoAb) only, in this case: 4 cycles of obinutuzumab;
~if less than CR (PR, SD): the immunochemotherapy program will be completed as outlined for Arm A: 2 cycles of G-CHOP Q21 + 2 cycles Q21 of obinutuzumab;
~Both Arms: in responding patients (CR, PR) at the end of induction a standard maintenance will follows (1 dose every 8 weeks for 2 years) with the same anti-CD20 MoAb used for induction.
~Patients in both arms with progressive disease at any time and patients in SD at the EOI shall be considered for salvage therapy at clinician discretion."
15725799|NCT05058131|Dietary Supplement|Dietary fibre|Dietary fibre as a powder, 24 g per day for 6 weeks
15725800|NCT05058131|Dietary Supplement|Placebo compound|Maltodextrin powder, 24 g per day for 6 weeks
15725772|NCT05058404|Drug|Immunochemotherapy regimen: G-CVP (Arm A)|"Arm A (Standard arm):
~4 cycles of G-CVP Q21 (21-days cycles) G-CVP = Obinutuzumab, Cyclophosphamide, Vincristine, Prednisone.
~Patients will undergo an early restaging after cycle 4: those with at least a stable disease will complete the induction treatment with 4 cycles of G-CVP Q21;
~Both Arms:
~Whichever the regimen, in responding patients (Complete Remission CR, Partial Remission PR) at the end of induction a standard maintenance will follows (1 dose every 8 weeks for 2 years) with the same anti-CD20 Monoclonal Antibody (MoAb) used for induction.
~Patients in both arms with progressive disease at any time and patients in stable disease SD at the End Of Induction (EOI) shall be considered for salvage therapy at clinician discretion."
15725773|NCT05058404|Drug|Immunochemotherapy regimen: G-CVP (Arm B)|"Arm B (Experimental arm):
~4 cycles of G-CVP Q21 (21-days cycles) G-CVP = Obinutuzumab, Cyclophosphamide, Vincristine, Prednisone.
~After cycle 4 patients will undergo an early restaging. Induction therapy shall be completed based on the response achieved and on the treatment chosen as below specified:
~if in CR: patients will receive no more chemotherapy but will complete induction with the Monoclonal Antibody (MoAb) only, in this case: 4 cycles of obinutuzumab;
~if less than CR (PR, SD): the immunochemotherapy program will be completed as outlined for Arm A: 4 cycles of G-CVP Q21
~Both Arms: in responding patients (CR, PR) at the end of induction a standard maintenance will follows (1 dose every 8 weeks for 2 years) with the same anti-CD20 MoAb used for induction.
~Patients in both arms with progressive disease at any time and patients in SD at the End Of Induction (EOI) shall be considered for salvage therapy at clinician discretion."
15725774|NCT05058391|Biological|Elaprase|Participants will receive a single dose of Elaprase 0.5 mg/kg intravenous infusion every week on Day 1.
15725775|NCT05058378|Device|perfusion index measurement|Clip will be attached to the patient's toe for perfusion index measurement
15725776|NCT05058365|Behavioral|dots Curriculum|"dots is a mindfulness curriculum developed by Mindfulness in Schools Project (MiSP) for children aged 3-6 in pre-school settings. The program consists of 15-minute twice weekly lessons that span for fifteen weeks. dots has various suggestions for Have A Go after each session - both in the classroom and at home."
15725777|NCT05058352|Drug|HS269|Oral tablets, once daily. Dose escalation from 50 mg QD, through 100 mg, 200mg, 300 mg, 400 mg, to 500mg.
15725779|NCT05058326|Diagnostic Test|Portable endoanal manometry|Endoanal manometry values will be obtained using de Anopress® device. Fecal incontinence severity questionaries will be filled and collected.
15725780|NCT05058326|Diagnostic Test|Endoanal ultrasound|To assess the integrity of the anal canal.
15725781|NCT05058326|Other|Incontinence severity scale questionaires|Wexner and St. Mark's scales.
15725782|NCT05058313|Device|Photobiomodulation|Six weekly photobiomodulation sessions (PBMT) using the MILTA ™ GYNECO vaginal probe.
15725783|NCT05058300|Device|CT Thorax|CT Thorax (GE Revolution with chest pain algorithm)
15725784|NCT05058287|Drug|Depo-Medrol 40Mg/Ml Suspension for Injection|40mg Depo-Medrol mixed with hemostatic matrix
15725785|NCT05058287|Drug|Placebo|1 mL of sterile normal saline mixed with hemostatic matrix
15725786|NCT05058274|Device|Implant of the AT-TORBI 709 lens|Implant of the AT-TORBI 709 lens
15725787|NCT05058248|Procedure|pudendal block|general anesthesia with an intravenous analgesic protocol then oral without anesthesia regional loco
15725788|NCT05058235|Other|Active Release Technique|"Moist Hot pack 10 mins/1 set/ (6 days/ week), TENS 20 mins/1 set/ (6 days/ week), Quadriceps Isometric Strengthening 5 sec hold, 10 reps/ 1 set/(6 days/ week), Active release Technique 5 reps/ 1 set/ (6 days/ week)
~A total of 2 weeks (12 sessions, 6 sessions/ week) were given each consisting of 40 mins."
15725789|NCT05058235|Other|Bent leg raise|"Moist Hot pack 10 mins/1 set/ (6 days/ week), TENS 20 mins/1 set/ (6 days/ week), Quadriceps Isometric Strengthening 5 sec hold, 10 reps/ 1 set/(6 days/ week), Bent leg raise 5 sec hold/ 5 sec stretch/ 3 reps/ 1 min rest interval/ 1 set/ (6 days/ week).
~A total of 2 weeks (12 sessions, 6 sessions/ week) were given each consisting of 40 mins."
15725790|NCT05058222|Other|Deep Breathing Exercise after every 3hrs, each session consists of 10 deep breaths Exercise|• The control program will consist of Deep Breathing Exercises (from Morning to night every three hours; each session consisting of 10 deep breaths with a few seconds pause between each set, for 3 days) in addition with progressive Exercises.
15725791|NCT05058222|Other|Deep Breathing Exercise after every 3hrs, each session consist of 30 deep breaths Exercise|• The intervention group will perform additional Deep breathing Exercises (from Morning to night every three hours; each session consisting of 30 deep breaths with a few seconds pause between each set, for 3 days).
15725792|NCT05058209|Drug|Triamcinolone acetonide extended-release injectable suspension|Zilretta (Triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of pain due to knee OA. The most commonly reported adverse reactions (incidence ≥1%) in clinical studies included sinusitis (2%), cough (2%), contusions (2%) and joint swelling (3%). For additional details, please see Package Insert (http://www.zilrettalabel.com/PI.pdf). The website for Zilretta additionally lists: joint pain, headache, back pain, sore throat and runny nose, and bruising as common side effects of receiving a Zilretta injection.
15725793|NCT05058209|Drug|Betamethasone sodium phosphate and betamethasone acetate Injectable Suspension|Celestone (betamethasone sodium phosphate and betamethasone acetate Injectable Suspension, USP 6 mg per mL) is indicated as an intra-articular injection for the management of chronic or long-term inflammation associated with multiple conditions including severe allergies, dermatological diseases, endocrine disorders, gastrointestinal diseases, hematologic disorders, neoplastic diseases, nervous system disorders, ophthalmologic diseases, renal diseases, respiratory diseases and rheumatic disorders, and others that may not be listed. Celestone Soluspan is available in generic form. The most commonly reported adverse reactions include acne, increased hunger, and weight gain.
15725796|NCT05058183|Diagnostic Test|ctDNA|Patients with stage 1 HER2 positive and triple negative breast cancer will receive ctDNA test after surgery. Treating clinicians will receive results and may change treatment plans in event of negative test.
15725798|NCT05058144|Dietary Supplement|Drinkable solution|the volunteer will consume the volume 300 ml of water with
15725801|NCT05058118|Drug|FL058|50mg、250mg、500mg、1000mg、1500mg、2000mg
15725802|NCT05058118|Drug|Placebo|empty bottle
15725803|NCT05058105|Drug|FL058 500mg and Meropenem 1000mg（ IV 120min）|"D1 qd;
~D2~ D8 q8h;
~D9 qd"
15725804|NCT05058105|Drug|FL058 Placebo and Meropenem 1000mg（ IV 120min）|"D1 qd;
~D2~ D8 q8h;
~D9 qd"
15725805|NCT05058105|Drug|FL058 1000mg（ IV 120min）|D1 qd;
15725806|NCT05058105|Drug|FL058 Placebo （ IV 120min）|D1 qd;
15725807|NCT05058105|Drug|Meropenem 1000 mg （ IV 120min）|D4 qd;
15725808|NCT05058105|Drug|Meropenem Placebo （ IV 120min）|D4 qd;
15725809|NCT05058105|Drug|FL058 1000mg and Meropenem 1000mg （ IV 120min）|"D7 qd;
~D8~ D14 q8h;
~D15 qd;"
15725810|NCT05058105|Drug|FL058 Placebo and Meropenem 1000mg （ IV 120min）|"D7 qd;
~D8~ D14 q8h;
~D15 qd;"
15725811|NCT05058105|Drug|FL058 1000mg and Meropenem 2000mg （ IV 120min）|"D1 qd;
~D2~ D8 q8h;
~D9 qd"
15725812|NCT05058105|Drug|FL058 Placebo and Meropenem 2000m（ IV 120min）|"D1 qd;
~D2~ D8 q8h;
~D9 qd"
15725813|NCT05058105|Drug|FL058 1000mg and Meropenem 2000mg （ IV 180min）|"D1 qd;
~D2~ D8 q8h;
~D9 qd"
15725814|NCT05058105|Drug|FL058 Placebo and Meropenem 2000m（ IV 180min）|"D1 qd;
~D2~ D8 q8h;
~D9 qd"
15725815|NCT05058105|Drug|FL058 2000mg and Meropenem 2000mg（ IV 180min）|"D1 qd;
~D2~ D8 q8h;
~D9 qd"
15725816|NCT05058105|Drug|FL058 Placebo and Meropenem 2000mg（ IV 180min）|"D1 qd;
~D2~ D8 q8h;
~D9 qd"
15725819|NCT05058079|Behavioral|Intraoperative Hand Held|Intraoperative hand holding
15725820|NCT05058066|Device|Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm abutment|The control implant included the previous generation as-machined titanium Baha® flange fixture (diameter 3.75mm; length 4mm) with 6mm conically shaped abutment.
15725821|NCT05058066|Device|Baha® BIA300 Implant (diameter 4.5mm; length 4mm) with 6mm abutment|The test implant and the implant used for the 3-week loading trial included the wide diameter titanium implant (diameter 4.5mm; length 4mm) with 6mm rounded, apically converging titanium abutment developed by Cochlear Bone Anchored Solutions AB (Mölnlyncke, Sweden). This system with an additional minor change to the internal abutment connection design was later commercialized under the name Cochlear™ Baha® BIA300 Implant with abutment. In addition to the difference in abutment shape and the wider diameter, the test implant incorporates small-sized threads at the implant neck and the moderately rough TiOblast™ (Dentsply, Mölndal, Sweden) surface on the intraosseous part of the implant6-8.
15725822|NCT05058066|Procedure|Early loading|Loading the implant at 3 weeks after implantation (instead of 6 weeks after implantation)
15725823|NCT05058053|Other|Cold application|Cold application was applied a total of 12 times on the infused PVC with cold gel packs for 15 minutes at 2-hour intervals.
15725824|NCT05058040|Drug|Sodium Oligomannate Capsules|Sodium Oligomannate Capsules, each capsule contains 150 mg of sodium oligomannate. The recommended treatment is oral administration, 450 mg (3 capsules) per dose, bid, in morning and evening.
15725825|NCT05058027|Device|GUARDIX-SG®|GUARDIX-SG® 6g prefilled syringe
15725826|NCT05058027|Device|Medicurtain®|Medicurtain® 5ml prefilled syringe
15725827|NCT05057988|Behavioral|Empowered Relief class|The participants will attend the Empowered Relief class online via Zoom. The class includes pain neuroscience education, as well as cognition, emotion, and physiologic self-regulation for people with chronic pain. Class participants will learn self-management skills and develop a personalized plan to use the skills every day. Participants will receive an audio file (Relaxation Response) post-class. The class provides patients rapid access to actionable skills for symptom management and pain relief.
15725828|NCT05057975|Device|Sunrise|Use of the Sunrise device for three nights to register mandibular movements that will be automatically analysed using artificial intelligence.
15725829|NCT05057975|Device|polysomnography|Reference protocol to diagnose OSA (in-lab or outpatient PSG)
15725831|NCT05057936|Biological|COVID vaccine|The enrolled patients will received COVID-19 vaccine according to the vaccine protocol in Thailand ie The ChAdox-1 nCOV-19 vaccine (day 1, day 84, 12 weeks duration) or Corona vac 2 doses (day 2, day 21, 3 weeks duration) of the study. All the participants underwent blood drawn for antibody and cellular immunity measurement before the final dose of vaccination, with 7 days before first vaccine dose and eight weeks after the second doses
15725832|NCT05057923|Biological|Bacillus subtilis|Bacillus subtilis, a harmless intestinal commensal, has earned in recent years, great reputation as a vaccine production host and delivery vector with advantages such as low cost, safe for human consumption and straightforward administration. The technology team has succeeded engineering Bacillus subtilis with spore coat proteins resembling the proteins of the nucleus and spikes of coronal virus. This product could have a vaccine like activity within the intestinal environment.
15725833|NCT05057910|Diagnostic Test|SARS-CoV-2 IgG II Quant|3ml of blood samples are collected, contained in heparin-free tubes, and centrifuged. Blood serum samples are collected and stored at the -80 Celcius degree. SARS-CoV-2 IgG antibodies in human serum and plasma are detected using chemiluminescent microparticle immunoassay (CMIA) technology on the ARCHITECT I 1000r System. Quality Control procedures will take place once daily, with three levels: one negative control and two positive controls. Sample, SARS-CoV-2 antigen-coated paramagnetic microparticles, and assay diluent are combined and incubated. The SARS-CoV-2 IgG antibodies present in the sample bind to the antigen-coated microparticles. The resulting chemiluminescent reaction is measured as a relative light unit (RLU). There is a direct relationship between the titres of IgG antibodies to SARS-CoV-2 in the sample and the RLU detected by the system optics. Interpretation of Results: < 50.0 AU/mL, Negative, ≥ 50.0 AU/mL, Positive
15725834|NCT05057897|Biological|AZD1222|10 mM histidine, 7.5% (w/v) sucrose, 35 mM sodium chloride, 1 mM magnesium chloride, 0.1% (w/v) polysorbate 80, 0.1 mM edetate disodium, 0.5% (w/v) ethanol, at pH 6.6
15725835|NCT05057884|Behavioral|Breathing training|Slow nasal breathing with intermittent end-expiratory apnoea for 15 min twice per day over 12 weeks.
15725975|NCT05056805|Other|Dietary Intervention|Consume high protein snack/meal/shake
15725836|NCT05057871|Device|Pulse electromagnetic field therapy|"It was applied with an electromagnetic field device (ASA Pmt Quatro Pro, ASA Srl Via A.Volta 9-36057 Italia) at 50 Hz frequency, 85 Gauss (8.5 milliTesla) intensity and for 30 minutes. The treatment period was 5 days a week for 4 weeks, in total. It was applied as 20 sessions.
~Therapeutic Exercise As a therapeutic exercise program; active shoulder ROM, isometric and progressive strengthening exercises for shoulder girdle muscles, codman pendulum exercises will be performed. It was planned to implement a total of 20 sessions 5 days a week for 4 weeks, for approximately 30 minutes. Exercises will be performed by a trained (at least 5 years experienced) physiotherapist, three times a day, in 3 sets, 10 repetitions."
15725837|NCT05057871|Device|Sham pulse electromagnetic field therapy|"Sham pulse electromagnetic field therapy was applied five sessions a week for four weeks, for a total of 20 sessions a day, using electromagnetic field device (ASA Pmt Quatro Pro, ASA Srl Via A.Volta 9-36057 Italy) without current flowing through the device.
~Therapeutic Exercise As a therapeutic exercise program; active shoulder ROM, isometric and progressive strengthening exercises for shoulder girdle muscles, codman pendulum exercises will be performed. It was planned to implement a total of 20 sessions 5 days a week for 4 weeks, for approximately 30 minutes. Exercises will be performed by a trained (at least 5 years experienced) physiotherapist, three times a day, in 3 sets, 10 repetitions."
15725838|NCT05057858|Drug|co-formulated 300 mg TDF/ 200mg FTC|Participants will be randomized into 1 of 3 groups to receive a controlled number of doses of a single tablet co-formulated 300 mg TDF/ 200mg FTC
15725839|NCT05057845|Drug|Tislelizumab|Tislelizumab will be initiated on day 14 after cryoablation. Tislelizumab will be administered at 200 mg i.v. every 3 weeks
15725840|NCT05057845|Drug|lenvatinib|Lenvatinib will be initiated on day 14 after cryoablation. Lenvatinib will be administered (bodyweight ≥ 60 kg, 12 mg; < 60 kg, 8 mg) orally daily every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
15725841|NCT05057845|Combination Product|US/CT-guided Percutaneous Cryoablation|Cryoablation will be performed with a two-cycle freeze-thaw phase protocol; US or non-contrast CT images will be obtained to visualize the evolving ablation zone
15725842|NCT05057819|Drug|Empagliflozin 25 MG|Treatment naive patients with bariatric bypass surgery will be given oral empagliflozin 25mg once daily for 20 days
15725843|NCT05057819|Drug|Placebo|Treatment naive patients with bariatric bypass surgery will be given oral placebo once daily for 20 days
15725844|NCT05057806|Drug|Empagliflozin 25 MG|Empagliflozin 25MG will be administered orally once per day for 3 months
15725845|NCT05057806|Drug|Placebo|The placebo will be administered orally once per day for 3 months
15725846|NCT05057793|Device|geko|The geko device will be self-administered and deliver 12 hours of therapy daily.
15725847|NCT05057780|Other|Communication Skills Curriculum|Our novel intervention adapted curricula around effective skills used to navigate common communication challenges in clinical practice. These skills were selected after determining patterns from multiple communication sessions delivered to over 6,000 healthcare providers. Our main goal was to enhance communication with patients by helping residents gain confidence and competence using these under-utilized communication skills, regardless of the communication challenge. Over the course of three, 1-hour long sessions on communication in the 2017-2018 academic year, internal medicine residents learned three of these highly effective and often under-utilized skills; reflective listening, responding to emotion and reframing, respectively.
15725848|NCT05057767|Drug|Midazolam injection|No premedication will be given to Patients in the group undergoing a standardized anesthesia protocol which include induction with thiopental (5 mg/kg) and fentanyl (1-2 μg/kg). Atracurium will be used as a muscle relaxant. After tracheal intubation, anesthesia will be maintained with isoflurane in a concentration of 0.8%-1.2%. Ventilation will be adjusted to produce normocapnia. At the end of surgery, reversal of residual neuromuscular blockade will be accomplished using i.v. atropine 20 μg/Kg and neostigmine 40 μg/kg.
15725849|NCT05057754|Behavioral|Cooling|Participants' dominant hand and wrist will be immersed in cool water (20°C) for five minutes. The cool water will be kept to around 20°C (19 - 21°C) by frequently checking the temperature and corrected when it rises to 20.5°C
15725850|NCT05057754|Behavioral|Heating|A heat pack wrapped in a towel will be applied to participants' dominant hand for five minutes.
15725851|NCT05057754|Behavioral|Exercising|Participants will be asked to participate in moderate-intensity physical activities to induce an increase in blood pressure. The physical activity will be two sets of 30 jumping jacks, followed by 15 squats. Participants are allowed to rest for 20 seconds between the two sets.
15725852|NCT05057754|Behavioral|Typing|All participants will be asked to perform a typing task with a standard wired keyboard. All subjects will be asked to type for five minutes.
15725853|NCT05057754|Behavioral|Using a mouse|"Participants will be asked to draw as many lower-case alphabet characters from a to z as possible using a standardized scroll mouse for five minutes in the Windows Microsoft Paint software."
15725854|NCT05057754|Behavioral|Cooking|Participants will be asked to participate in a cooking trial following a prespecified cooking recipe of Rice Krispy Treat. he participant will be asked to follow the procedures as follows: (1) cut and put wax paper in the pan; (2) cut butter into 4 pieces; (3) place butter in a pot over a portable stove and stir until the butter is completely melted; (4) add four oz of marshmallows and stir until melted; (5) add cereal and the rest of marshmallows and stir until all ingredients are combined (6) transfer the ingredients to the pan and use a silicone spatula to pat the ingredients evenly into pan.
15725855|NCT05057741|Behavioral|Multimodal prehabilitation|"Patients who will receive a multimodal prehabilitation program consisting of guided self-care activities at home that include exercise, nutrition and relaxation. Information Will be share by e health. Monitored by telephone daily during the first week and three times a week between the second and fourth week.
~The final evaluation of the program will be performed one working day after the control appointment with surgery, which will be scheduled ten days after hospital discharge; and the satisfaction survey will be applied. At 30 days after surgery, a telephone follow-up will be made to inquire about complications and mortality. On that day, self-care recommendations will be given."
15725856|NCT05057728|Behavioral|Social-Emotional Prevention Program enhanced version|The intervention is provided for all children for whom parental consent is obtained. The intervention includes a classroom curriculum, teacher training and parent training.
15725857|NCT05057715|Biological|VCN-01|Intravenous administration of VCN-01
15725858|NCT05057715|Biological|huCART-meso Cells|Intravenous administration of huCART-meso cells
15725859|NCT05057702|Other|Specialized Tumor Board Treatment Plan|Specialized Treatment Plan of up to four FDA approved drugs based on participant's screening results will be assigned by PNOC specialized tumor board
15725860|NCT05057689|Drug|Intranasal Dexmedetomidine (4 mcg/kg)|Dexmedetomidine 100 mcg/mL (concentration of 200 mcg/2 mL) will be atomized for intranasal administration at a dose of 4 mcg/kg (0.04 mL/kg) according to a weight-based dosing chart prior to laceration repair. The maximum dose will be 200 mcg.
15725861|NCT05057689|Drug|Intranasal Fentanyl (2 mcg/kg)|Fentanyl 50 mcg/mL (concentration of 100 mcg/2 mL) will be atomized for intranasal administration at a dose of 2 mcg/kg (0.04 mL/kg) according to a weight-based dosing chart prior to laceration repair. The maximum dose will be 100 mcg.
15725862|NCT05057689|Drug|Intranasal Midazolam (5 mg/kg)|Midazolam 5 mg/mL (concentration of 10 mg/2 mL) will be atomized for intranasal administration at a dose of 0.3 mg/kg (0.06 mL/kg) according to a weight-based dosing chart prior to laceration repair. The maximum dose will be 10 mg.
15725863|NCT05057676|Behavioral|Immediate Autoimmune Intervention Mastery Course (AIM)|Immediate access to an on line audio and video course with education about strategies to grow and improve resilience, diet quality, exercise, stress reduction and self-care
15725864|NCT05057676|Behavioral|Immediate Question and Answer sessions. (AIM Q and A sessions)|Immediate access to videos answering common questions about the course concepts. One video released each week, 7 videos total.
15725865|NCT05057676|Behavioral|Delayed Autoimmune Intervention Mastery Course (delayed AIM course)|Delayed access to an on line audio and video course with education about strategies to grow and improve resilience, diet quality, exercise, stress reduction and self-care
15725866|NCT05057676|Behavioral|Delayed AIM Question and Answer sessions|Delayed access to videos answering common questions about the course concepts. One video released each week, 7 videos total.
15725867|NCT05057663|Drug|Bleomycin and 5-fluorouracil|"In the bleomycin-treated group, bleomycin vial will be diluted first with 5 ml distilled water At time of treatment session 2 ml of lidocaine 2% and 1 ml of the bleomycin stock solution will be taken in 100-unite insulin syringe. Thus, the working bleomycin solution will be used in treatment 1 mg/ml. The bleomycin solution will be injected intralesional till blanching of the wart will be occurred. The amount of injection ranging from 0.2, 0.5, 1 ml according to size of warts; (5 mm, 10 mm, >10 mm) maximum for 1 ml in single wart and 2ml in treatment session. Treatment session will be done every two weeks maximum four sessions.
~In 5-fluorouracil treated group, 5-fluorouracil vial ( 1 ml of 50 mg/ml 5-FU will be mixed with 0.25 ml of lidcaine 2% Every wart will be injected with 0.1 ml of the previous mixture into it base using an insulin syringe till blanching of the warts maximum 2ml of 5-FU per session. Treatment session will be done every two week for maximum 6 sessions"
15725868|NCT05057650|Dietary Supplement|Vegan diet|Provide
15725869|NCT05057637|Device|Optical coherence tomography measurements|Optical coherence tomography measurements in femoropopliteal tract
15725870|NCT05057624|Other|Placebo GC-MRT|Participants will hear music continuously throughout the trials, without regard to the faces they look at.
15725871|NCT05057624|Other|GC-MRT|Participants will hear music as a reward for looking at neutral faces and the music will stop when they focus on angry faces.
15725872|NCT05057624|Other|Exposure|Participants will hear music of their choice when they focus on angry faces, and when they look at neutral faces the music will stop.
15725873|NCT05057611|Other|CRT-targeted strategy associated with a clinical hemodynamic phenotyping to personalize initial resuscitation in septic shock patients|A combination of combine a CRT-targeted strategy with a clinical hemodynamic phenotyping that may aid to personalize initial resuscitation with potential additional fluid-sparing effects.
15725874|NCT05057611|Other|Usual care (UC)|- Patients allocated to the UC group will be managed by the clinical staff according to usual practice at their sites including decisions about hemodynamic and perfusion monitoring, and all treatments, but should follow general recommendations of the Surviving Sepsis Campaign to avoid extremes of clinical practice. This includes basic hemodynamic targets such as a MAP >65 mmHg, heart rate (HR) <120 beats per minute (BPM), arterial oxygen saturation (SaO2) >94%, Hb > 7 gr/dl, and the use of NE as the first vasopressor and crystalloids as the fluid of choice.
15725875|NCT05057598|Other|Community-based participatory research on diet and lifestyle|"The intervention use a web site that contains a section to exchange information on recipes and on strategy to comply with the recommendations, and an agenda to inform on meetings, conferences, kitchen classes, walking groups, organised by the participant themselves. The investigators are developed specific recommendations for women with different characteristics. The investigators intend to improve the specificity of information with short questionnaires on portion size of relevant items using photographs or usual container in the kitchen and develop a health application for smartphone to facilitated a more efficient and timely exchange on information.
~The participants will receive a free phone number for emergencies, active 2 hours a day for 5 days a week."
15725876|NCT05057585|Behavioral|Turning in bed, arm and leg exercises|"Turning in bed, arm and leg exercises were applied to only the experimental group for 15 minutes and 12-24 hours prior to surgery."
15725976|NCT05056805|Other|Nutritional Intervention|Receive nutritional consultation and guidelines
15725977|NCT05056805|Other|Quality-of-Life Assessment|Ancillary studies
15725978|NCT05056805|Other|Questionnaire Administration|Ancillary studies
15725979|NCT05056805|Other|Resistance Training|Complete strengthening exercise
15725980|NCT05056792|Other|NMES strength training for 8 week|Plyometric training for 8 week
15725982|NCT05056779|Drug|CD14152 placebo|Participants will receive loading dose of 60 mg (2×30 mg) SC injection of placebo at baseline. Thereafter 30 mg placebo will be administered via single SC injection Q4W up to week 12.
15725880|NCT05057533|Other|a questionnaire based on Rome IV Diagnostic criteria of IBS|"The Rome IV criteria for the diagnosis of IBS require that patients have had recurrent abdominal pain on average at least 1 day per week during the previous 3 months that is associated with two or more of the following
~Related to defecation (may be increased or unchanged by defecation)
~Associated with a change in stool frequency
~Associated with a change in stool form or appearance The Rome IV criteria (May 2016) only require abdominal pain in defining this condition; discomfort is no longer a requirement owing to its nonspecificity, and the recurrent abdominal pain. [2] Supporting symptoms include the following:Altered stool frequency Altered stool form Altered stool passage (straining and/or urgency) Mucorrhea Abdominal bloating or subjective distention."
15725881|NCT05057520|Other|Questionnaire|Completion of the questionnaire by the patient after consultation with the general practitioner
15725882|NCT05057507|Diagnostic Test|Atrial cardiac magnetic resonance imaging|To include assessment of atrial size, shape, function, fibrosis and fat
15725883|NCT05057507|Diagnostic Test|Atrial electro-anatomic mapping|To include assessment of atrial voltage and local activation time
15725884|NCT05057507|Other|Atrial fibrillation symptom questionnaire|To include assessment of atrial fibrillation symptoms and quality of life
15725885|NCT05057507|Diagnostic Test|Patch-based 2 week ambulatory monitor|To assess atrial fibrillation burden post-ablation
15725886|NCT05057494|Drug|Acalabrutinib|Dose formulation: Capsule
15725887|NCT05057494|Drug|Venetoclax|Dose formulation: Tablet
15725888|NCT05057494|Drug|Obinutuzumab|Dose formulation: Injection
15725893|NCT05057455|Procedure|cytokine hemadsorption|the laboratory and clinical results of cytokine hemadsorption as an immunomodulation therapy in ICU patients diagnosed with sepsis or septic shock.
15725895|NCT05057429|Device|Procellera Bioelectric Dressing|Procellera is single layer, broad-spectrum antimicrobial wound dressing. Embedded in the dressing are microcell batteries made of elemental silver and zinc applied in a dot-matrix pattern. The bioelectric dressing will be applied to surgical site wound with a hydrogel.
15725896|NCT05057429|Other|Standard Gauze Dressing|Standard of care non-adherent gauze dressing will be applied to surgical site with vaseline.
15725897|NCT05057416|Behavioral|Exercise Adherence|Our current study will compare three exercise groups which will all vary in intensity. Participants will be randomly assigned to one of the three groups. Two groups will be assigned to high intensity bouts of exercise with an active rest between, and one group will perform moderate intensity continuous training without resting. All groups will exercise for 20 minutes. Exercise adherence and it will be measured by a self-report online Google Document.
15725898|NCT05057390|Dietary Supplement|New Human Milk Fortifier (NHMF)|"The case study product will be added to human milk during the hospitalization and will continue after discharge for at least 1 week (7 days), to obtain community data. NHMF prescription will be specified on an individual basis by the investigating Dietitian responsible for the infant's nutritional management. The intervention period will end when the infant does not require NHMF (according to local neonatal guidelines and/or clinical indication).
~The case study product will be labelled specifically for the case study and will be available in a powder format.
~Full preparation, storage and safety instructions will be given to the parent/caregiver by the investigating Dietitian before commencing the case study product to ensure its correct and safe use."
15725899|NCT05057377|Diagnostic Test|Standard Overground Assessment|The standard overground methods to assess three main components of walking are the 10 Meter Walk Test (meters/second, used to measure speed), 5x Sit-to-Stand (seconds, used to measure strength), and the 6-Minute Walk Test (meters, used to measure endurance).
15725900|NCT05057377|Diagnostic Test|Robotic Safety-Environment Assessment|The methods for assessment of the three main components of walking in the robotic environment will be the maximum walking speed tolerated (meters/second, to measure speed), deadband resistance (kilograms, to measure strength), and the 6-minute walk test (meters, to measure endurance).
15725901|NCT05057364|Other|Heart Smart Virtual Self-Management Group|The Heart Smart Intervention is a 6 week virtual program consisting of one individual technology training session followed by 5 one hour group education sessions.
15725902|NCT05057351|Other|Isopentenyltheophylline 0.44% + Glycerin 4.56%|Application of topical cream twice a day on the area affected by Atopic Dermatitis
15725903|NCT05057351|Other|Glycerin 4.56%|Application of topical cream twice a day on the area affected by Atopic Dermatitis
15725904|NCT05057338|Behavioral|CoreDISTparticipation|CoreDISTparticipation is a thorough intervention that contains coordination of services (physiotherapy, MS-nursing and work adaptations) between the MS-OP clinic and the municipality aiming to improve function, physical activity and employment in individuals with MS.
15725905|NCT05057338|Behavioral|Standard care|The standard care group will follow regular consultations at the MS-outpatient clinic including a session with the physiotherapist. Furthermore, this group will follow usual care in the municipality which might include other forms of physiotherapy or physical activity. These will be registered.
15725906|NCT05057325|Other|Pulpectomy using single file system ( One Shape file)|Rotary file instrument for pulpectomy of primary molars ( One shape file)
15725907|NCT05057325|Other|Pulpectomy using single file system ( WaveOne Gold file)|Rotary file instrument for pulpectomy of primary molars ( WaveOne Gold file)
15725908|NCT05057312|Behavioral|Experimental arm 1|Video narrative persuasion
15725909|NCT05057312|Behavioral|Experimental arm 2|Written narrative Persuasion
15725910|NCT05057312|Other|Experimental arm 3|Enhanced Access to HPV vaccines
15725911|NCT05057312|Other|Experimental arm 4|Video narrative persuasion; Enhanced Access to HPV vaccines
15725912|NCT05057312|Other|Experimental arm 5|Written narrative Persuasion; Enhanced access to HPV vaccines
15725913|NCT05057299|Other|retrospective data analysis|chart review, analysis and reporting outcomes
15726022|NCT05056389|Drug|Oxaliplatin|Administration of oxaliplatin intraperitoneally
15729018|NCT05032144|Drug|STSA-1002 injection|Intravenous injection
15725914|NCT05057286|Procedure|Clinical crown lengthening surgery|"Clinical dental crown lengthening surgery protocol: a clinical crown lengthening surgery was performed.
~Post-operation protocol Patients were all prescribed antibiotics , anti-inflammation, analgesic, and an antiseptic mouthwash. Patients were instructed for oral hygiene and recalls.
~Botulinum Toxin A injection One hundred units (U) of botulinum toxin A (BTX-A) were diluted with 2.5ml of sterile saline solution without shaking. 1 mm syringe with a 30-gauge needle was used to get 0.25ml BTX-A for four-point injection, or 0.6ml in case injection of 6 points. Cold compress was applied extraoral 5 mins at injection site before injection.
~After local anesthesia, the doctor administered slowly 2,5 U of diluted BTX-A at each point until white cellulite appeared.
~Patients were recalled two weeks (T2), and two months (T3) after injection."
15725915|NCT05057273|Drug|BT-11 (Omilancor)|Subjects will be randomized to receive omilancor (BT-11) 1,000 mg once-daily for 12 weeks. Subjects will also be given placebo SC injections every two weeks that are identical to adalimumab in appearance.
15725916|NCT05057273|Biological|adalimumab|Subjects will be randomized to receive adalimumab SC injections at the following intervals: 160 mg at week 0, 80 mg at week 2 and 40 mg at weeks 4, 6, 8, 10 and 12. Subjects will also be given once daily oral placebo tablets that are identical to omilancor (BT-11) in appearance.
15725917|NCT05057260|Other|No drug invervention|No clinical trial
15725918|NCT05057247|Drug|Duvelisib|"Duvelisib capsules should be swallowed whole with a glass of water (approximately 8 ounces).
~Advise patients not to open, break, or chew the capsules. Duvelisib may be administered without regard to meals; however, subjects should avoid grapefruit and grapefruit juice while on duvelisib.
~continue for up to 24 months."
15725919|NCT05057247|Drug|Docetaxel|Docetaxel chemotherapy once every 21 days (by intravenous infusion) over about 30- 60 minutes at each visit. This will continue for up to 24 months
15725920|NCT05057234|Diagnostic Test|FoundationOne liquid CDx|FoundationOne liquid CDx testing
15725921|NCT05057234|Behavioral|Quality of life questionnaires|Quality of life questionnaire - EQ5D
15725922|NCT05057221|Drug|Uproleselan|Uproleselan should be administered intravenously (IV) into a peripheral line, a central catheter, or a peripherally inserted central line catheter (PICC). Infusion should take place at a steady rate over a period of 20 minutes ±2 minutes using a syringe pump or IV pump.
15725923|NCT05057208|Biological|COVID|COVID vaccination
15725924|NCT05057195|Radiation|Interstitial radiation therapy|From 30 to 50 Gy,
15725925|NCT05057195|Radiation|Postoperative external beam therapy|50 Gy and locally on the tumor bed up to 10-26 Gy, depending on the status of the resection margin
15725926|NCT05057182|Biological|BNT162b2|BNT162b2 mRNA vaccine (Cominarty®, BioNTech/Fosun Pharma), one dose (0.3mL after dilution) contains 30 micrograms of COVID-19 mRNA Vaccine embedded in lipid nanoparticles.
15725927|NCT05057169|Biological|BNT162b2|BNT162b2 is a nucleoside-modified mRNA encoding the trimerized SARS-CoV-2 spike glycoprotein. The vaccine is formulated in lipid nanoparticles that increase the efficiency of delivery of the mRNA into cells after intramuscular injection. BNT162b2 encodes the SARS- CoV-2 full-length spike, modified by two proline mutations to lock it in the prefusion conformation and more closely recreate the intact virus with which the elicited virus- neutralizing antibodies interact. mRNA vaccines use the pathogen's genetic code as the vaccine; hence they exploit the host cells to translate the code and generate the target spike protein. The protein then acts as an intracellular antigen to stimulate the immune response of the vaccinated individual. The mRNA is then degraded within days.
15725928|NCT05057169|Biological|CoronaVac|CoronaVac is a Vero cell-based, aluminium hydroxide-adjuvanted, β-propiolactone- inactivated vaccine based on the CZ02 strain. This strain of SARS-CoV-2 was isolated from the bronchoalveolar lavage of a hospitalized patient and is closely related to the 2019-nCoV- BetaCoV Wuhan/WIV04/2019 strain. Each 0.5 ml dose is composed of 3 μg of inactivated SARS-CoV-2 virus. The excipients are aluminium hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride, and water for injection.
15725929|NCT05057156|Behavioral|cognitive rehabilitation|patients have to use an app with cognitive games
15725930|NCT05057143|Device|Implants|3D printed implants
15725931|NCT05057143|Device|Plates|Titanium plates
15725932|NCT05057130|Drug|Doxorubicin, Cisplatin, Methotrexate|IV
15725933|NCT05057130|Drug|Doxorubicin, Cisplatin|IV
15725934|NCT05057117|Device|Microwave thermolysis|Baseline treatment with microwave thermolysis in one axilla and botulinum toxin A in the contralateral axilla, as allocated by randomization
15725935|NCT05057117|Drug|Botulinum toxin A|Baseline treatment with microwave thermolysis in one axilla and botulinum toxin A in the contralateral axilla, as allocated by randomization
15725936|NCT05057091|Other|Lomber roll techniques group (n=23)|Direct manipulation will be applied to the lumbar region with the lumbar Roll technique. Painful segment will be determined.
15725937|NCT05057091|Other|Posterior- anterior central vertebral manipulation techniques (n=23)|After initial assessments were made, both groups had high velocity and low amplitude (HVLA) or V. Level manipulation will be applied in the form of 2 different direct manipulation techniques
15725938|NCT05057078|Behavioral|mindfulness-based stress reduction program|groups of 10 people will be formed among the patients included in the mindfulness program group. A mindfulness-based stress reduction program will be done once a week for eight weeks and will take approximately 60-120 minutes. A plan will be made with the patients for the day and time of the session. During this process, no application will be made to the control group. Meetings will be held as an online session via Zoom Video Communications.
15725939|NCT05057052|Drug|Sintilimab|Sintilimab plus regorafenib will be initiated on day 14 after cryoablation. Sintilimab will be administered at 200 mg i.v. every 3 weeks.
15725940|NCT05057052|Drug|Regorafenib|Regorafenib will be initiated on day 14 after cryoablation. Regorafenib 80 mg was given orally once daily on days 1-21 of a 28-day cycle until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
15725941|NCT05057052|Combination Product|US/CT-guided Percutaneous Cryoablation|Cryoablation will be performed with a two-cycle freeze-thaw phase protocol; US or non-contrast CT images will be obtained to visualize the evolving ablation zone
15725981|NCT05056779|Drug|Nemolizumab|Participants will receive loading dose of 60 milligram (2×30 mg) subcutaneous (SC) injection of nemolizumab at baseline. Thereafter 30 mg nemolizumab will be administered via single SC injection once in 4 week (Q4W) up to week 12.
15725942|NCT05057026|Other|Training Program Adult Mental Health Practice Support Program|"The Adult Mental Health Practice Support Program (PSP) was designed in 2009 by the General Practice Services Committee (GPSC) to address needs expressed by the province's family physicians to improve patient care in British Colombia. Its content and delivery model has been designed using evidence-based key ingredients and implication factors understood to be important for effective stigma reduction. These include the following:
~the use of contact-based education,
~skills-building to increase confidence and provide another management option with or without drugs particularly if access to mental health support services is difficult or absent
~tools - using the principles of cognitive behavioural theory
~The training will be delivered virtually over a total of 4 sessions two weeks apart, covering an 8-week period. A two hour virtually delivered booster session will be provided to students approximately one year after the delivery of the initial training."
15725944|NCT05057000|Other|aerobic exercises + Diet|Frequency 5-6 days per week Intensity To perform moderate intensity for weight-bearing aerobic exercise Time Goal of 20-30 min per session of moderate-intensity aerobic activity per week
15725945|NCT05057000|Other|diet proram|diet program for anorexic adolescent girls
15725946|NCT05056987|Device|Lehfilcon A contact lenses|CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use
15725947|NCT05056987|Device|Senofilcon A contact lenses|CE-marked spherical soft contact lenses worn according to to the product package insert/Instructions for Use
15725948|NCT05056987|Device|AOSEPT PLUS with HydraGlyde|Hydrogen peroxide-based cleaning and disinfecting solution
15725949|NCT05056974|Biological|UB-421|10 mg/kg, weekly, Subjects will receive weekly UB-421 during the 8-week
15725950|NCT05056974|Drug|chidamide|10 mg/dose, twice a week for 8 weeks, at the interval of no less than 3 days between the two doses.
15725951|NCT05056961|Other|Multiparametric mesurements|Multiparametric assessments will necessitate the use of a plastic belt to record electro-impedancemetry tomography data; and a nano-gatsric tube fitted with esophageal and gastric low pressure balloons
15725952|NCT05056948|Other|artificial intelligence (AI) computer assisted design (CAD)|Maxillary right first molar will be removed in the computer and will be designed by artificial intelligence system
15725953|NCT05056935|Drug|LB1148|A total of 700 mL of LB1148 will be administered orally as a split dose before surgery.
15725954|NCT05056935|Drug|Placebo|A total of 700 mL of placebo will be administered orally as a split dose before surgery.
15725955|NCT05056922|Behavioral|Tele-PCIT|"Families randomized to Tele-PCIT will receive a time-limited version of PCIT via telehealth. The first 5 sessions focus on the child directed interaction (CDI) phase. The first session includes a teaching session where the parent will learn PRIDE/Do skills and Don't skills. The next 4 CDI sessions include coaching where the therapist coaches the parent on the these skills within the context of play. The first PDI session includes a teaching session where parents will be given instructions for providing commands and timeout procedures. During the 4 PDI coaching sessions, the therapist coaches the parent through timeout procedures. Handouts are emailed to families throughout therapy. The treatment period is 12 weeks to complete the 10 sessions to account for scheduling challenges. Families will be provided a Bluetooth headset for sessions. Families who do not have access to a computer, tablet, or smartphone with internet access will be provided with a tablet for therapy use."
15725956|NCT05056922|Behavioral|Treatment as Usual|Families randomized to Treatment-as-Usual (TAU) will receive brief feedback and psychoeducation during the baseline visit and will be provided with community resources and referrals as needed. The TAU procedures will reflect the level of care families receive after an ASD assessment or professional consultation in our own clinic. For addressing behavioral concerns specifically, families will be provided handouts on behavior management tips, given access to a webinar workshop reviewing basic behavioral parenting principles, and instructed to engage with available services. The Vanderbilt Treatment & Research Institute for ASD (TRIAD) Center offers a webinar series for managing challenging behaviors that parents will be directed to along with the Autism Speaks Challenging Behavior Toolkit handouts. The TAU period will be 12 weeks in length to match time specifications for the active treatment condition.
15725957|NCT05056909|Device|Kidney ACTion|AI-supported software for chronic kidney disease care
15725958|NCT05056909|Other|Standard of care|Standard of care
15725959|NCT05056896|Drug|Aspirin|Capsule taken orally
15725960|NCT05056896|Other|Placebo|Capsule taken orally
15725961|NCT05056883|Drug|K-237 0.3-0.4mg/kg (once daily)|Ivermectin 3mg tablet
15725962|NCT05056883|Drug|Placebo 0.3-0.4mg/kg (once daily)|Placebo 3mg tablet
15725963|NCT05056870|Device|ACUVUE Oasys 1-Day with HydraLuxe Technology for Astigmatism|TEST
15725964|NCT05056870|Device|ACUVUE Oasys 1-Day with HydraLuxe Technology|CONTROL
15725965|NCT05056857|Procedure|Biospecimen Collection|Undergo collection of blood sample
15725966|NCT05056857|Other|Electronic Health Record Review|Medical charts are reviewed
15725967|NCT05056844|Procedure|Contrast Enhanced Digital Mammography|Undergo CESM
15725968|NCT05056844|Procedure|Digital Tomosynthesis Mammography|Undergo DBT
15725969|NCT05056844|Drug|Iodinated Contrast Agent|Given iodine-based contrast agent IV
15725970|NCT05056844|Other|Questionnaire Administration|Ancillary studies
15725971|NCT05056831|Other|First Interview|1) needs related to psychosocial distress and health behaviors in rural patients with cancer, 2) needs related to implementing interventions within the treatment setting, 3) barriers to intervention delivery at UTHealth North Campus Tyler, and 4) preferred means/methods for referring participants and receiving information related to the intervention.
15725972|NCT05056831|Other|Second Interview|"1) needs related to psychosocial distress and health behaviors, 2) barriers and facilitators to participating in a multicomponent intervention during treatment (e.g., barriers related face-to-face vs.
~videoconference delivery, text messaging, dose, etc.), 3) preferred methods for receiving health information and the intervention (e.g., mode, delivery agent), 4) additional cultural adaptations needed for rural cancer patients and survivors, and 5) availability of support and resources that will aid participation"
15725973|NCT05056818|Other|Electronic Health Record Review|Review of medical records and past imaging examinations
15725974|NCT05056805|Other|Aerobic Exercise|Receive aerobic exercise encouragement
15725984|NCT05056753|Device|HWBV chair|vibration-actuated, saddle-seat type stool
15725985|NCT05056740|Biological|Data analysis|Analysis of the data from routine care at the end of the diagnostic work-up
15725991|NCT05056714|Other|Questionaries|The patient will answer several questionaries
15725992|NCT05056701|Other|annual follow-up during 10 years|an annual follow-up is carried out systematically for a total of 10 years in order to detect the subsequent occurrence of CKD
15725993|NCT05056688|Diagnostic Test|Testicular Model BSE/TSE Training Set|The investigators will use the Testicular Model BSE/TSE Trainer to transform individuals' routine testicular self-examination into behavior.
15725994|NCT05056675|Procedure|PENG block|All patients will undergo the same preoperative, standardized protocol. Upon arrival to the operating room, patients will be placed in supine position. Routine, standard pre-medication will be applied before induction of general anesthesia. After intubation, the PENG block is performed. Under sonographic guidance using a curvilinear probe, puncture will be performed in a lateromedial direction until the needle tip reaches the plane between the iliopsoas tendon and periosteum and between the anterior inferior iliac spine and iliopubic eminence. After a negative aspiration test, the blinded test item will be injected in the plane beneath the iliopsoas muscle. Patients will be randomly assigned to receive the test item (20 mL of ropivacaine 0.5%, Naropin). The anesthesiologist and the surgeon are blinded to the product injected.
15725995|NCT05056675|Procedure|Placebo|ll patients will undergo the same preoperative, standardized protocol. Upon arrival to the operating room, patients will be placed in supine position. Routine, standard pre-medication will be applied before induction of general anesthesia. After intubation, the PENG block is performed. Under sonographic guidance using a curvilinear probe, puncture will be performed in a lateromedial direction until the needle tip reaches the plane between the iliopsoas tendon and periosteum and between the anterior inferior iliac spine and iliopubic eminence. After a negative aspiration test, the blinded test item will be injected in the plane beneath the iliopsoas muscle. Patients will be randomly assigned to receive the placebo (20 mL of NaCL 0.9%). The anesthesiologist and the surgeon are blinded to the product injected.
15725996|NCT05056662|Diagnostic Test|Invasive functional evaluation with either Pd/Pa, FFR, iFR or contrast FFR|Enrolled patients will undergo invasive functional evaluation of coronary stenosis followed by percutaneous revascularization if appropriate. Patients in Group 3 will have target lesion re-assessed using either PdPa, FFR, iFR or contrast FFR.
15725997|NCT05056636|Diagnostic Test|Plasma α-Gal A activity; Plasma Lyso-GB3; GLA genetic sequencing.|"Screening Visit 1:
~Male patient will first screened by enzymatic assay (Cutoff: 1.3 μM /hr)
~Female patient will first screened by lyso-GB3 (Cutoff: > 5ng/ml)
~Screening Visit 2:
~If both male and female who has deficient enzymatic level (Cutoff: 1.3 μM /hr) or lyso-GB3 level (Cutoff: > 5ng/ml) respectively, those patients will be confirmed whether they have carried Fabry Disease causing mutation by whom GLA genetic sequencing."
15725998|NCT05056623|Behavioral|Dyadic pain management program|"Face-to-face part: The DPM will start with 20-30 minutes of physical exercise supervised by research assistant, followed by 20-minutes of pain management education. Communication skills regarding the practice of various pain management techniques by the participants and their caregivers will be taught. At the end of the session, the caregiver and research assistant will help the older adults to make portfolio entries on the activities of the day, to help them recall the various pain-relief methods learned in each class.
~Home-based part: An exercise book will be given to guide them in performing exercises at home. It is recommended to perform 30 minutes of exercise, 3 times a week, at home and the more frequent the exercise time, the better.
~All participants will join a WhatsApp group to receive teaching materials and videos of the physical exercises learned, for practice at home. The team will produce compact disc (CD) with the exercise video clips to the dyads for revision."
15725999|NCT05056623|Other|Usual care and pain management pamphlet|Usual care and pain management pamphlet
15726000|NCT05056610|Other|food antigens on duodenal mucosa|Administration of food antigens on duodenal mucosa and determining the response through confocal laser endomicroscopy
15726001|NCT05056584|Biological|Glucagon infusion|One hour glucagon-clamp followed by one hour of blood sampling
15726002|NCT05056584|Biological|Primed tracer infusion|Infusion of primed isotopically labelled glucose, amino acids and lipids. From 2 hours prior to glucagon infusion and throughout the test day,
15726003|NCT05056571|Behavioral|Progressive muscle relaxation|Progressive muscle relaxation exercise is a type of exercise in which tense muscles in your body gradually relax and relax. It is an application that allows you to forcefully stretch every muscle group in your body, hold it tight for 5 seconds, and then relax it. Visualize your tense muscles throughout this exercise and imagine that the feeling of relaxation spreads to all your muscles in the form of a wave and the tension is relieved. Keep breathing throughout the entire exercise.
15726004|NCT05056558|Drug|Baricitinib|Continued standard of care (SOC) together with oral 4 mg Baricitinib tablet from day 1 to day 14
15726005|NCT05056558|Drug|Placebo|Continued standard of care (SOC) together with oral placebo tablet from day 1 to day 14
15726006|NCT05056545|Behavioral|C4 Intervention|"C4 Intervention, is an innovative form of Post Partum Family Planning (PPFP). PPFP methods include: the copper intrauterine device, hormonal implant, tubal ligation, and (after 6 weeks post-partum in breastfeeding women) Depo-Provera and oral contraceptive pills. These are provided as current, standard of care in Rwanda, are procured by the government, and administered by trained nurses and doctors.
~The C4 training will occur at the 5 pilot facilities. Training will include a 2-day didactic session covering PPFP provision, follow-up, use of the C4 counseling flipchart; mock counseling sessions; and PPIUD and PP implant insertion and removal trainings. The study team will train government clinic staff in family planning, ANC, L&D, and IV to promote C4 at the selected facilities. 'Happy Clients' will be recruited from women who received promotions and selected PPFP to join a clinic-based PPFP promotions team. Women interested in PPFP will be referred to the facility by their CHW."
15726007|NCT05056532|Diagnostic Test|patient assessment|subjective and objective measurement will be performed in patients with PAH
15726008|NCT05056519|Biological|Live Attenuated Influenza Vaccine|Live Attenuated Influenza Vaccine placebo, containing H1, H3 and B type influenza Live Attenuated virus.
15726009|NCT05056519|Biological|Live Attenuated Influenza Vaccine placebo|Live Attenuated Influenza Vaccine placebo, not containing H1, H3 and B type influenza Live Attenuated virus.
15726010|NCT05056506|Procedure|EPLBD|Endoscopic papillary large balloon dilation for Choledocholithiasis
15726011|NCT05056506|Procedure|ELPBD+ESD|Endoscopic papillary balloon dilation combined with limited endoscopic sphincterotomy for Choledocholithiasis
15726012|NCT05056493|Other|Caremap app|The Caremap app is intended for organizing and tracking patient-reported health insights over time and sharing those trends and patient-centered goals with their providers, not for urgent/emergent clinical communication. Information shared with providers through the app will be used for clinical care at the discretion of their provider. Use of the app to share information and health insights will not replace usual, existing channels for patient-provider communication (e.g., MyChart, phone calls, email, pager, etc.).
15726013|NCT05056480|Other|Surveys|Parent/caregivers participants will complete multiple repeating surveys to gather family-reported perspectives on the impact of the PCCI care management program. Clinical staff participants will complete multiple repeating surveys that gather clinician perspectives on the impact of the PCCI care management program. Parent/caregiver and clinical staff participants will also be invited to participated in one-on-one semi-structured interviews with the study team.
15726014|NCT05056467|Procedure|Induction of Labor|Induction of Labor at 39 weeks of gestation
15726015|NCT05056454|Behavioral|Online therapy with coaching|Participants with moderate depressive symptoms on the CAT-MH (and no current suicidality) will be allocated to access a 3-lesson prenatal depression online cognitive-behavioral therapy course (MUMentum) or 6-lesson mixed anxiety and depression cognitive-behavioral therapy course, both from the program offerings of This Way Up. Lesson content is presented in the form of an illustrated story about two fictional characters who are anxious and depressed, but who gain mastery over their problems using CBT techniques. Following each lesson, participants download a document that summarizes the key information in each lesson and which includes practical homework exercises that reinforce the content of the lesson. Participants are encouraged to practice their lesson homework for at least one week before starting the next lesson. Participants will additionally receive up to 9 coaching sessions with a STAND coach, in addition to an initial orientation session.
15726016|NCT05056454|Behavioral|Clinical care|Participants with severe depressive symptoms or significant suicidality on the CAT-MH will be allocated to access clinical care, which entails weekly psychotherapy sessions and psychiatric care, when needed or appropriate. While clinical care will be available for the entire 6-month duration of the treatment component of the study, participants will be informed that on average therapy is completed within 13 sessions. The schedule of psychiatric care will be determined by the provider and will be comparable to that provided in the TAU arm.
15726017|NCT05056428|Behavioral|8-week mindfulness program|The .b Foundations course is an 8-week mindfulness program developed by Mindfulness in Schools Project (MiSP) for school teachers and personnel. It includes a taster session and 8 weekly sessions. Each session lasts for 1.5 hours with a specific theme (e.g. Lesson 1 waking up from autopilot). Formal and informal mindfulness practices (e.g. mindful eating, body scan, mindful walking, habit releaser etc.), psychoeducation, cognitive exercises, inquiry, and home practice are involved.
15726018|NCT05056415|Other|Everyday Life Rehabilitation (ELR)|"Everyday Life Rehabilitation (ELR) is an intervention model for integrated occupational therapy in close collaboration with housing staff in sheltered and supported housing facilities (Lindström, 2007; 2011), aiming at personal recovery and engagement in meaningful everyday activities for persons with SPD. The mediators are: personcentred, motivational, recovery- and activity-based methods, negotiation of user goal priority and expected outcome; methods for training in real-life situations; devices for collaboration; support from staff on an everyday basis; and an educational package including web-sections, manuals, and collegiate tutorial.
~The language and actions of professionals promote hope, self-discovery and shared-decision making, shaped in partnership with residents. The resident is also encouraged to access different resources outside of health and social care such as family, peer and social support, out-of-housing strategies, and sources in the open society."
15726019|NCT05056415|Other|Treatment as usual (TAU)|No standardized instructions about the efforts is given to staff at the accommodations. Usually, only short terms efforts are offered to residents, such as prescribing technical aids.
15726020|NCT05056402|Biological|3 doses of the Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)|Three doses administered intramuscularly at 0, 1 and 6 month.
15726021|NCT05056402|Biological|2 doses of theRecombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)|Two doses administered intramuscularly at 0 and 6 month.
15726025|NCT05056363|Other|Home Based Traditional Scoliosis Exercises|Patients in this group will receive posture exercises, strengthening exercises, diaphragmatic breathing exercises and stretching exercises.
15726026|NCT05056363|Other|Core Stability Training|Patients in this group will receive traditional scoliosis exercises. In addition, the training group will receive core stabilization exercises for multifidus, diaphragm,erector spines, rectus abdominis, internal and external obliques, quadratus lumborum, iliopsoas, gluteus maximus, and pelvic floor muscles.
15726027|NCT05056350|Other|Questionnaires|Quality of life questionnaires, work perception questionnaires, psychological distress questionnaire
15726028|NCT05056350|Other|back to work coaching|Back-to-work support program including an individual interview to identify patient needs and expectations, 7 coaching workshops (every 3 weeks +/- 15 days) and a final individual assessment post workshops
15726029|NCT05056337|Drug|Lenvatinib 4 MG Oral Capsule [Lenvima]|patients will be treated with lenvatinib in combination with toripalimab and TACE (on demand)
15726030|NCT05056337|Drug|Toripalimab|patients will be treated with lenvatinib in combination with toripalimab and TACE (on demand)
15726031|NCT05056337|Procedure|TACE|Hepatic arterial chemoembolization
15726032|NCT05056324|Device|Online vestibular rehabilitation tool|For those randomized to the intervention group, a 6 weeks duration vestibular rehabilitation will be delivered using an online tool (YrselTräning)
15726033|NCT05056324|Other|Standard care (written instructions leaflet)|For those randomized to the control group, a 6 weeks duration standard vestibular rehabilitation will be delivered using a written instructions leaflet
15726034|NCT05056311|Other|Decision Aid Website|The (private) decision aid website contains information in text, graphic, and video form about hypospadias and considerations for choosing surgery and no surgery.
15726035|NCT05056298|Other|Custom made insole|Custom made arch support insole with semi-rigid arch support will be made using the casting method, plaster cast of both feet in a subtalar neutral position will be taken from each subject by highly specialized orthotist. The negative casts will be placed in calcaneal vertical position and custommolded orthosis will be fabricated to positive molds obtained from the negative casts with the goal to control the pronation movement of the foot
15726036|NCT05056298|Other|Strengthening exercises of extrinsic foot muscles|Participants will perform extrinsic foot muscles strengthening exercises with both ankles 3 times per week, 20 minutes for 8 weeks. they will be trained using a progressive resistance protocol using Thera-Band elasticated bands. Subjects will be progressed weekly throughout the training period according to progressive resistance protocol for dorsiflexors, planterflexors, evertors and investors muscles.
15726037|NCT05056298|Other|Strengthening exercises of intrinsic foot muscles|The patient will assume the same position as in intrinsic foot muscle assessment, then he will be instructed to hold the position for a count of 10 seconds and attempt to maintain the MLA as steady as possible during the entire time without any compensatory extrinsic foot muscle activity. Following the 10-seconds, slowly and with eccentric control allow the foot to pronate and the MLA to lower to a relaxed state .
15726038|NCT05056298|Other|Standard insole|Patient will be instructed to wear a standard prefabricated flat insole as a placepo treatment iniside his shoes for 2 months (8 weeks), 6 to 8 hours per day, and adhere to wearing the orthoses during outdoor walking and during extrinsic foot muscle training.
15726040|NCT05056246|Drug|AMG 133|Solution for injection
15726041|NCT05056233|Other|Systane Hydration lubricant eye drops|Sterile solution indicated for the temporary relief of burning and irritation due to dryness of the eye
15726042|NCT05056220|Drug|Human albumin|20%
15726043|NCT05056220|Drug|sodium chloride|0.9%
15726044|NCT05056207|Other|Cohort I (patients receiving annual lymphedema screening|patientns who previously underwent preoperative perometer lymphedema screening
15726045|NCT05056207|Other|Cohort II (patients followed intensively for lymphedema)|patients who have recently undergone ALND
15726046|NCT05056194|Drug|Valiloxybate|XW10172 MR Granules for Oral Suspension
15726047|NCT05056194|Other|Placebo|Placebo Granules for Oral Suspension
15726048|NCT05056181|Other|Physical Activity|Physical activity
15726079|NCT05055895|Drug|Anticholinergic burden|"The anticholinergic burden (ACB) was assessed using the Anticholinergic Burden Scale.
~Higher ACB was described as equal or higher than 1."
15726080|NCT05055882|Other|children and adult with Still's disease in Auvergne-Rhône-Alpes-Limousin hospital|Comparison of Adult-Onset Still's disease phenotypes
15726050|NCT05056155|Other|Systane Complete|Propylene glycol 0.6% eye drops for replenishing deficiencies in both the lipid and aqueous layers of the tear film
15726051|NCT05056142|Procedure|Epidural Anesthesia|Patients will receive epidural analgesia with 15 ml isobaric bupivacaine 0.125% plus fentanyl 2 μg/mL.
15726052|NCT05056142|Procedure|Spinal Analgesia|Patients will receive Spinal analgesia with 5 mg bupivacaine and 25 μg of fentanyl in a 2 ml volume.
15726053|NCT05056129|Behavioral|Sensor-controlled digital game (SCDG)|"The SCDG will involve a narrative, the goal of which is to help an avatar in the game avoid rehospitalization by using game points, earned via the participant's real-time behaviors, in game tasks that help maintain the avatar's optimal HF health status. Real-time behaviors of weight-monitoring and physical activity will be tracked by an off-the-shelf sensors and app (Withings). The data from the Withings sensors will then be routed to our SCDG app.
~The digital game paired with sensors will enable objective tracking of real-time behaviors such as physical activity, and weight monitoring, and provide personalized, contextually relevant feedback (e.g., reduce fluid intake or call doctor for weight gain) to motivate engagement in and generate habit formation of heart failure related self-management behaviors."
15726054|NCT05056129|Behavioral|Sensor Only|Real-time behaviors of weight-monitoring and physical activity will be tracked by an off-the-shelf sensors and app (Withings). This group will also be provided with standardized evidence-based HF educational material.However, the data from the Withings sensors will not be routed to the SCDG.
15726055|NCT05056116|Drug|Surufatinib Toripalimab|Surufatinib at a dose of 250mg Qd, with humanized anti-PD-1 monoclonal antibody Toripalimab injected intravenously 240mg per 3 weeks until disease progresses or unacceptable tolerability occurs.
15726056|NCT05056103|Device|TrachFlush|The attending nurses activate the TrachFlush when there are secretions present in the larger airways that need to be removed. If this results into a push of airway secretions past and above the cuff of the endotracheal tube, no further action is needed. If unsuccessful, the nurse will perform a standard tracheal suctioning procedure to remove the secretions. In a subset of patients with an endotracheal tube that allows subglottal suctioning, the exact amount of airway secretions present above the cuff will be measured each time the TrachFlush is used.
15726057|NCT05056090|Procedure|Patients will receive MV in PP|Putting the patient in a prone position
15726058|NCT05056077|Other|Counseling|Receive support person coaching
15726059|NCT05056077|Other|Educational Intervention|Receive personal report and booklet on nutrition and physical activity for patients with colon or rectal cancer
15726060|NCT05056077|Behavioral|Health Education|Receive health coaching
15726061|NCT05056077|Other|Health Promotion and Education - Direct Text Messaging|Receive text messages
15726062|NCT05056077|Other|Health Promotion and Education - Digital health tool kit|Receive digital health tool kit
15726063|NCT05056077|Other|Questionnaires|Quality of Life and Behavioral Questionnaires
15726064|NCT05056064|Other|Oral exercise|exercise remain tongue
15726065|NCT05056051|Device|WATS-3D tissue sampling prior to forceps biopsies|WATS-3D is a brush-based tissue sampling technique. Abrasive brush sampling of large areas of the esophagus pick up cells to obtain trans-epithelial specimens. This technique samples much larger tissue areas than standard forceps biopsies. Analysis is then done by proprietary neural-network based computer scanning and molecular diagnostics to identify abnormal cells.
15726066|NCT05056051|Device|WATS-3D tissue sampling following forceps biopsies|WATS-3D is a brush-based tissue sampling technique. Abrasive brush sampling of large areas of the esophagus pick up cells to obtain trans-epithelial specimens. This technique samples much larger tissue areas than standard forceps biopsies. Analysis is then done by proprietary neural-network based computer scanning and molecular diagnostics to identify abnormal cells. This will be done after forceps biopsies in this arm.
15726067|NCT05056038|Procedure|Lateral Quadratus Lumborum block|Local anesthetic may spread to the T6-L1 spinal nerves and paravertebral area by spreading through the lateral QLB to the transversus abdominis plane, and posteriorly via the anterior thoracolumbar fascia.
15726068|NCT05056038|Procedure|Posterior Quadratus Lumborum Block|In posterior QLB, the local anesthetic can spread on the anterior and lateral cutaneous branches of T4-L1 spinal nerves by administration of the agent to the lateral interfascial triangle.
15726069|NCT05056025|Dietary Supplement|Postbotics and Vitamins|2 capsule 3 times a day, before meals
15726070|NCT05056025|Dietary Supplement|Vitamins|2 capsule 3 times a day, before meals
15726071|NCT05055999|Drug|First line EC/EP+Atezolizumab|Etoposide (100mg/㎡) Carboplatin (AUC=4) Atezolizumab(1200mg) ivgtt, every 21 day
15726072|NCT05055986|Device|Semiautomatic segmentation of open-source software|Semiautomatic segmentation of open-source software is accurate as of the manual segmentation of commercial software.
15726073|NCT05055960|Diagnostic Test|Stroke simulation and machine learning|Using simulation and machine learning approaches to classify the source of embolic stroke.
15726074|NCT05055947|Drug|First line EC/EP+Atezolizumab|Etoposide (100mg/㎡) Carboplatin (AUC=4) Atezolizumab(1200mg) ivgtt, every 21 days
15726075|NCT05055934|Drug|SHR-1314 injection|SHR-1314 injection
15726076|NCT05055934|Drug|placebo|placebo
15726077|NCT05055921|Device|Multi Pulse Therapy as delivered from the Cardialen External Stimulation System|"The Cardialen External Stimulation System (CESS) is the research delivery system for the proprietary Cardialen MultiPulse Therapy (MPT). The CESS is a custom designed and built research device. It is comprised of off-the-shelf commercial components (power supplies, waveform generators, laptop computer, monitor, rack, ECG system, leads, etc.) combined with a custom electrical circuit board and custom software.
~Other Names:
~Unpinning Termination Therapy
~Multi-stage therapy
~Multi-stage electrotherapy
~MultiPulse Therapy"
15726078|NCT05055908|Drug|First line EC/EP+Atezolizumab|Etoposide (100mg/㎡) Carboplatin (AUC=4) Atezolizumab(1200mg) ivgtt, every 21 days
15726081|NCT05055856|Diagnostic Test|urine sample|Each participant will give a urine sample for diagnose of asymptomatic bacteriuria
15726082|NCT05055856|Diagnostic Test|Blood and urine sample|Each participant will give a urine and blood sample for diagnose of SIADH
15726083|NCT05055843|Procedure|Magnetic Resonance Imaging|Undergo 3D MRI
15726085|NCT05055817|Other|bloody stool group|bloody stool appear in the hospitalized neonate
15726086|NCT05055817|Other|non-bloody stool group|bloody stool do not appear in the hospitalized neonate
15726087|NCT05055804|Device|ELG|"The effectiveness of ELG to standardized blood test methods (fingerstick) and comparison to AlcNOW + (or equivalence) and of laboratory test results.
~Human subject requirements during ELG study will not challenge diabetics or non-diabetics glycemic event. For example, diabetes type 1, the subject will not have to adjust their insulin or glucose. For type 2 diabetes, the subject will not have to adjust their oral hypoglycemic agent or glucose, as well."
15726088|NCT05055791|Drug|SYHX1903|SYHX1903 tablets, orally, qd
15726089|NCT05055778|Behavioral|SmokefreeTXT|"The program is identical to the publicly available program available through the National Cancer Institute Smokefree.gov Initiative but has been set up to be delivered through a research account. The program will send 3-5 messages a day over 7 weeks, with one week to prepare for a quit attempt and 6 weeks of cessation support messages. Participants can get real time support for cravings, mood, and slips by texting keywords to the program. They keywords are CRAVE, MOOD, and SLIP. Participants can also re-set their quit date by texting NEW. The program asks questions each week to ask about smoking status and about mood and cravings."
15726090|NCT05055765|Procedure|Microneedling|MN will be carried out 1mm below of the gingival margin on the gingiva of the tooth to be treated with thirty-gauge (0.255 mm) lancet needles.
15726091|NCT05055765|Procedure|injectable- platelet rich fibrin|I-PRF will be prepared according to Choukroun PRF method.
15726092|NCT05055752|Drug|Pharmaceutical-lipid aspirin (PL-ASA)|Subjects receive the first drug, followed by a 7-day washout period, then receive the second drug.
15726093|NCT05055739|Device|Rigid plate X steel wires|Compare the sternal alignment between the fixation with rigid plate X steel wires.
15726094|NCT05055726|Drug|Benzydamine Hydrochloride 0.15% w/v oromucosal solution|Benzydamine Hydrochloride 0.15% w/v oromucosal solution (mouthwash), Angelini Pharma S.p.A.
15726101|NCT05055700|Behavioral|Mobile app with prenatal genetic testing information|In the intervention group, participants will be asked to download, register, and review a mobile app on their own mobile phones before their appointment with maternal-fetal medicine specialists. This mobile app includes prenatal genetic testing information about amniocentesis, chorionic villus sampling, nuchal translucency screening, cell-free DNA, triple/quad/penta screening, anatomy ultrasound, and carrier screening.
15726102|NCT05055687|Drug|FL058|2500mg、3000mg
15726103|NCT05055687|Drug|Placebo|empty bottle
15726104|NCT05055687|Drug|FL058|500mg、1000mg、2000mg
15726105|NCT05055687|Drug|Placebo|empty bottle
15726106|NCT05055674|Behavioral|Motherly app|The Motherly app is organized in four different modules: 1) Library: a collection of brief texts on several topics related to health and pregnancy, 2) Health: journeys with varying degrees of interactivity designed to teach and engage participants in well-established psychological techniques (behavioral activation, cognitive restructuring, emotion regulation, stress management techniques, mindfulness and meditation, sleep hygiene techniques), 3) Pregnancy and motherhood: a module to help mothers keep track of their health care visits, medical exams, and their childrens' development, and 4) Profile: a module allowing participants to keep track of activities and goals completed in the Health module journeys, and to assess depression and anxiety symptoms with brief questionnaires, with results displayed graphically in a timeline and in the the form of short feedback texts.
15726631|NCT05051345|Behavioral|Telephone-Based Intervention|Receive telephone counseling sessions
15726107|NCT05055674|Behavioral|COMVC app|The COMVC displays over 30 brief psychoeducational videos on several topics related to general mental health, such as depression, anxiety, stress, sleep, problem solving techniques, among others. Psychoeducation is limited to video only (no interactivity). The content of these videos was developed by clinicians, researchers, and professors from the Psychiatry Department of the Medical School of the University of Sao Paulo and from the Federal University of Rio Grande do Sul. Mental health monitoring is delivered by means of brief questionnaires assessing depression and anxiety symptoms, which can be filled at users' discretion. Users' responses are displayed graphically in a timeline and they receive short feedback texts based on assessment results.
15726108|NCT05055661|Other|Pharmaceutical Teleconsultation|The pharmacist will apply the teleconsultation according to the elaborated workflows and will follow in seven steps: scheduling the teleconsultation; pre-consultation, in which the pharmacist will make a checklist of the adequacy of the teleconsultation environment; presentation of the professional and the objectives of the teleconsultation to the patient; search for information about the patient and their pharmacotherapy; identification of problems related to pharmacotherapy; elaboration of a care plan and appointment for the re-consultation.
15726109|NCT05055648|Radiation|Photon Radiotherapy|nCXT consists of weekly carboplatin and paclitaxel for 5 weeks, following the CROSS trial. The radiation dose will be either 41.4 Gy in 23 fractions or 50.4 Gy in 28 fractions
15726110|NCT05055648|Radiation|Proton Radiotherapy|nCPT consists of weekly carboplatin and paclitaxel for 5 weeks, following the CROSS trial. The radiation dose will be either 41.4 Gy in 23 fractions or 50.4 Gy in 28 fractions
15726111|NCT05055635|Radiation|Pencil beam proton therapy|Neo-adjuvant or definitive pencil beam proton therapy: 55 Gy(RBE)/44fx - 65 Gy(RBE)/52 fx (1.25 Gy per fraction), two fractions a day
15726112|NCT05055609|Drug|TRE-515|TRE-515 will be administered orally once daily at least 1 hour prior or 2 hours after eating at approximately the same time each day. Dosing will be continuous with no breaks between cycles. Subjects will continue to receive successive cycles of TRE-515 treatment as long as they do not demonstrate progressive disease, experience an unacceptable toxicity, and both the Sponsor and PI consider additional treatment with TRE-515 to be within the best interest of the subject.
15726113|NCT05055596|Behavioral|Tai Chi|Qigong/Tai Chi Easy is a manualized intervention with formal training for instructors through the Institute of Integral Qigong and Tai Chi (IIQTC). The protocol can be modified based on participant needs and physical abilities. Qigong/Tai Chi Easy uses a series of repeated and simple-to-learn movements (rather than long forms with complicated choreography).
15726114|NCT05055596|Behavioral|Health Coaching|The Health Education group will be adapted from a previously developed time and attention control condition used in HIV research. Additional health education material will be based on information learned in the qualitative interviews conducted prior to the start of this study. Examples of session material include the following: sleep hygiene, healthy diet, sun safety, and healthy homes.
15726115|NCT05055583|Drug|Toripalimab in Combination With Platinum-based Chemotherapy|Toripalimab will be administered at a fixed dose of 80 mg (2ml)/vial, IV, D1, with a full dose of 240 mg at one time, every 3 weeks for 3-4 cycles. Squamous cell carcinoma will be combined with cisplatin/carboplatin and Nab-paclitaxel: carboplatin, AUC=5, D1, IV, q3w, or cisplatin, 75 mg/m2, IV, q3w, and Nab-paclitaxel, 130 mg/m2, D1, IV, q3w, for 3-4 cycles. Non-squamous cell carcinoma will be combined with cisplatin/carboplatin and Pemetrexed, cisplatin/carboplatin is the same as above, Pemetrexed will be given at 500 mg/m2, D1, IV, q3w, for 3-4 cycles.
15726116|NCT05055583|Procedure|Surgical treatment stage|After the last treatment (Day 21 of Cycle 4), surgery was performed within 4-6 weeks.
15726117|NCT05055583|Drug|Adjuvant treatment stage|Postoperatively, a comprehensive evaluation will be conducted by the investigator, and the intention will receive maintenance therapy within 6-12 weeks of the MDT assessment. Toripalimab: a fixed dose of 80 mg (2ml)/vial, IV, D1, a full dose of 240 mg at one time, every 3 weeks administered until PD or intolerable toxicity, for a maximum duration of 1 year.
15726118|NCT05055570|Other|No intervention|No intervention
15726119|NCT05055544|Drug|Fosfomycin|a single dose of fosfomycin (3 g) powder dissolved in 75 ml water and 2 placebo tablets t.i.d. for 7 days (group A),
15726120|NCT05055544|Drug|Bearberry|a single dose of placebo powder dissolved in 75 ml water and 2 bearberry tablets t.i.d. for 7 days (group B).
15726121|NCT05055518|Drug|APL-102 Capsules|"Dose escalation: A total of seven dose levels (1mg, 2mg, 3mg, 5mg, 7mg, 9mg and 11mg) are planned.
~Dose extension: After RP2D determined, the RP2D dose level will be extended to enroll 6-10 subjects to further evaluated the safety and antitumor activity of APL-102."
15726122|NCT05055505|Diagnostic Test|Take home saliva kits|Saliva kits will be made available at schools for pick up to support symptomatic testing using PCR for students, staff and family members.
15726123|NCT05055492|Diagnostic Test|Take home saliva kits|Saliva kits will be made available at schools for pick up to support symptomatic testing using PCR for students, staff and family members.
15726124|NCT05055453|Device|MyPhonak Junior App|The primary objective is to evaluate the effects on speech intelligibility of resulting from the changes that children and adolescents (aged 7 to 17 years) make to the volume control, directionality and noise reduction of the hearing of the hearing aids using the myPhonak app. First, in a controlled laboratory environment under the guidance of the principal investigator is tested. Then, using sound scenarios, the child is allowed to try out two programs with the aid of using the app and the volume control, respectively. After this, the speech comprehension of sentences in noise is tested in the individual programs using the Oldenburg Sentence Test (OLSA).
15726125|NCT05055427|Drug|Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng)|"Patients take Shen Cao Gan Jiang Tang (Gan Cao Gan Jiang Tang with Ginseng), one bag of decoction (90ml) two times a day for 10 days. In additional, patients also receive the Standard of Care (SOC) for the treatment of COVID-19 based on the Vietnam Ministry of Health guideline.
~Ingredients per formula (tang): 12 grams of honey-fried Radix Glycyrrhizae, 6 grams of Rhizoma Zingiberis (stir-baked), 6 grams of Panax Ginseng. The decoction of concentrated extract is packed into aluminum foil vacuum bag, 90ml per bag, 1 formula (tang) is equivalent to 2 bags. Patients use the decoction directly from the bag.
~Daily dose: 1 bag per time, 2 times per day"
15726126|NCT05055414|Drug|UI030|Budesonide/Arformoterol dry powder inhaler, 3 inhalations b.i.d at 3 days and 2 inhalations b.i.d at 11 days
15726130|NCT05055388|Other|Multidrug-resistant bacteria|Multidrug resistance was defined as acquired non-susceptibility to at leas one agent in three or more antimicrobial categories.
15726131|NCT05055375|Other|questionnaire survey|We will conduct a questionnaire survey of outpatients.
15726132|NCT05055362|Other|Honey Spice Group|Consume baked good daily for 10 days and provide samples of saliva, urine and dietary habits and spice intake.
15726133|NCT05055349|Other|corneal ring segments|ring hard segments inserted within corneal stroma using femtolaser
15726134|NCT05055336|Other|Gastric emptying breath test|The gastric emptying breath test is used to diagnose gastroparesis. Participants ingest spirulina in a meal and samples are taken every 45 minutes for 4 hours.
15726135|NCT05055336|Other|Stomach ultrasound|Ultrasound of the fundus of the stomach will be done immediately after ingestion of the test meal, at 15 minutes, and at 30 minutes.
15726136|NCT05055323|Drug|Pyrvinium Pamoate|Given PO
15726137|NCT05055310|Diagnostic Test|MicRNAs test|plasma micRNAs concentration
15726138|NCT05055297|Device|SELUTION SLR™ DEB 014|a non-surgical procedure that uses a catheter to inflate a drug-eluting balloon to open up peripheral below-the-knee arteries that have been narrowed by chronic limb-threatening ischemia
15726139|NCT05055297|Device|Plain (Uncoated) Balloon Angioplasty (PTA)|a non-surgical procedure that uses a catheter to inflate a commercially available, non-drug-eluting balloon to open up peripheral below-the-knee arteries that have been narrowed by chronic limb-threatening ischemia
15726140|NCT05055284|Other|Electromyographic-biofeedback guided (EMG-BF) isometric quadriceps strengthening with patellar taping five days a week for six weeks.|Patellar Taping, electromyography biofeedback (EMG-BF), Strength Training
15726143|NCT05055245|Other|cycles|Patients are grouped according to the number of IVF/ICSI cycles.
15726144|NCT05055232|Drug|XZP-3621|tablets, dosage ranged from 50 mg to 600 mg, quaque die（QD）with the meal.
15726145|NCT05055206|Diagnostic Test|SPECT-CT|99m-Technetium Sulfur Colloid will be injected prior to the scan.
15726146|NCT05055193|Drug|Evaluation at 24 months corrected age: respiratory outcome, Neurodevelopmental outcome, Growth outcome|Data concerning the 24 months corrected age outcomes were collected from the medical records of the ECL'AUR preterm infants follow-up network.
15726147|NCT05055180|Diagnostic Test|Invasive hemodynamics and myocardial biopsies|Invasive hemodynamic characterization (biventricular pressure volume loop assessment) and biventricular myocardial biopsies
15726148|NCT05055167|Drug|Envafolimab|single agent, 300mg Q3W IH until disease progressed
15726149|NCT05055154|Device|Very low calorie diet|In hospital patients will eat prepared diet with 567 kcal a day during 3 weeks
15726150|NCT05055141|Other|Care to Share poster|The Care to Share poster enabled patients to share written information about who they are as people with their hospital caregivers.
15726151|NCT05055128|Drug|X842|Patients will receive X842 tablets.
15726152|NCT05055128|Drug|X842 Dummy|Patients will receive matching placebo tablets for X842.
15726153|NCT05055128|Drug|Lansoprazole|Patients will receive Lansoprazole capsule.
15726154|NCT05055128|Drug|Lansoprazole Dummy|Patients will receive matching placebo capsules for Lansoprazole.
15726155|NCT05055115|Procedure|Balloon Eustachian Tuboplasty|Balloon Eustachian Tuboplasty of the cartilaginous part of ET. The procedure is performed endonasally under general anesthesia. It is believed that BET leads to micro-bleeding in the mucosa with subsequent scarring and expansion of ET.
15726156|NCT05055102|Other|Data collection|demographics co-morbidities risk factors operative, hospital and vascular follow-up data
15726157|NCT05055076|Device|PODEYE TORIC|Patients will be contacted consecutively and will be enrolled after the patient informed leaflet has been given to them and after obtaining their consent to the scientific use of their data collected retrospectively (preoperative, surgery, postoperative routine visits). Patients will only be enrolled after the routine 4-6 months visit has been performed.
15726158|NCT05055063|Drug|Belantamab mafodotin|by vein over 30-60 minutes on Day 1 of each 56-day cycle for the first 6 cycles.
15726159|NCT05055050|Drug|UGN-201|Intravesical 200 mg /50 ml x 1 dose
15726160|NCT05055037|Other|Neurofeedback|In neurofeedback (NF), the brainwave activity is measured by an electro-encephalography and fed back to the person as an auditory or visual signal, rewarding the person each time progress is made toward normalizing dysregulated neural activity. The learning mechanism is at its base considered to be operant conditioning, where the behavior of the participant-in this case, neurological activity-is gradually changed through repeated reinforcement. In neurofeedback, this simple learning mechanism is accelerated by continuous and instant feedback, with rewards occurring as often as every second. The NF intervention included 12 NF training sessions, one session per week, off approximately 12-20 min. The protocol was a replicate of the setup of recent NF studies investigating NF as a treatment for chronic PTSD. The feedback was based on a single channel recording, rewarding brainwave frequencies associated with a calm and relaxed state and inhibiting drowsiness and hyperarousal.
15726161|NCT05055024|Drug|Mazindol|Drug: NLS-2
15726162|NCT05055011|Other|Electronic Health Record Review|Review of medical records
15726163|NCT05055011|Other|Survey Administration|Complete survey
15726164|NCT05054998|Radiation|Fludeoxyglucose F-18|Given IV
15726165|NCT05054998|Procedure|Magnetic Resonance Imaging|Undergo PET/MRI
15726166|NCT05054998|Procedure|Positron Emission Tomography|Undergo PET/MRI
15726167|NCT05054985|Device|Multi-Branched Thoracoabdominal Stent Graft System|Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with multi-branched thoracoabdominal stent graft system .
15726168|NCT05054972|Procedure|Exclusion of the aortic aneurysm.|Surgical procedure in which an aortic aneurysm is excluded.
15726169|NCT05054959|Other|consolidation chemotherapy|6 cycles CAPOX after chemoradiotherapy
15726170|NCT05054959|Other|induction chemotherapy|4 cycles CAPOX before and 2 cycles CAPOX after chemoradiotherapy
15726171|NCT05054946|Procedure|Laparoscopic cystectomy|All surgeries will be performed under general anesthesia by laparoscopically.
15726172|NCT05054933|Other|ultrasound capsule endoscopy|Healthy volunteers or patients with suspected esophageal disease will be enrolled to take ultrasound capsule endoscopy examination followed by conventional endoscopic ultrasound examination within 2 weeks.
15726176|NCT05054894|Other|Therapeutic Plasma Exchange (TPE)|"Following all necessary screening and consenting protocol, patients will be scheduled for the plasmapheresis procedure.
~Plasmapheresis
~On the days of the scheduled procedure, patients will undergo up to 1.5 hours of plasmapheresis treatment. Patients will be awake and situated in a relaxed position in a reclined chair. The plasmapheresis device to be used is the Fresenius Kabi 'Amicus', which is currently FDA approved for a variety of clinical conditions. In one treatment, roughly 60-70% of a patient's plasma can safely be replaced; by using six consecutive treatments, more of the patient's plasma (approaching 100%) will be replaced in an exponential fashion."
15726177|NCT05054881|Other|sciatic nerve blockade under ultrasound control with a peripheral nerve stimulator|"Following the ultrasound visualization of the femoral nerve, a insulated injection needle was connected to the nerve stimulator . Under ultrasound visualization guidance, the needle of the electronic nerve stimulator was positioned at the sciatic nerve (in plane) from its lateral side at a slightly superior position . A marker for LA introduction was the visualization of the needle end near the nerve, and a positive muscular response . Subsequently, the introduction of LA solution was initiated.If LA was spreading from the lateral side down to the nerve, then the needle was replaced to the upper point of the nerve and the rest of LA was introduced, and vice versa . The presence of a complete and incomplete spread of LA along the entire circumference of the nerve was assessed. Correspondingly, if the anesthetic was spreading upwardly, the needle would be downwardly replaced.
~In addition, a femoral nerve block is performed."
15726178|NCT05054881|Other|sciatic nerve blockade under ultrasound control without a peripheral nerve stimulator|"Under ultrasound visualization guidance, the needle owas positioned at the sciatic nerve (in plane) from its lateral side at a slightly superior position . A marker for LA introduction was the visualization of the needle end near the nerve. Subsequently, the introduction of LA solution was initiated. The position of the needle was corrected 1-2 times according to the type of anesthetic spread. If LA was spreading from the lateral side down to the nerve, then the needle was replaced to the upper point of the nerve and the rest of LA was introduced, and vice versa . The presence of a complete and incomplete spread of LA along the entire circumference of the nerve was assessed. Correspondingly, if the anesthetic was spreading upwardly, the needle would be downwardly replaced.
~In addition, a femoral nerve block is performed."
15726179|NCT05054868|Drug|Oxycodone|Subjects randomized to the control group will receive oxycodone for postop pain management (standard of care).
15726180|NCT05054868|Drug|Ketorolac|Subjects randomized to the treatment group will receive oxycodone and ketorolac for postop pain management.
15726181|NCT05054855|Behavioral|: Cognitive Support Technology (CST)|"Cognitive Support Technology (CST) products and strategies are used to help people with disabilities compensate for or accommodate cognitive limitations (including those related to interpersonal communication and social cognition) that present difficulties for them in the performance of desired social roles, especially education and employment.
~CSTs may be mainstream everyday technologies such as tablet computers or they may be specialized devices designed for specific goals such as step-by-step instruction in the performance of a particular task (Scherer, 2012)."
15726182|NCT05054842|Drug|Retagliptin phosphate tablets、metformin sustained-release tablets|Retagliptin phosphate tablets 100mg+ metformin sustained-release tablets 1500mg or 2000mg based on prior medication
15726183|NCT05054842|Drug|Retagliptin phosphate placebo tablets、metformin sustained-release tablets|Retagliptin phosphate 100mg placebo tablets + metformin sustained-release tablets 1500mg or 2000mg based on prior medication
15726184|NCT05054829|Behavioral|PEERS®: program for the education and enrichment of relational skills|providing evidence-based social skills treatment to preschoolers, adolescents, and young adults with autism spectrum disorder (ASD)
15726185|NCT05054816|Device|Investigational adaptive directional microphone strategy|A receiver-in-canal hearing aid developed by the Study Sponsor used with the investigational adaptive directional microphone strategy that is expected to improve sound quality of speech in a car.
15726186|NCT05054816|Device|Comparator adaptive directional microphone strategy 1|A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator adaptive directional microphone strategy 1 that is used with the default settings as specified in the manufacturer's fitting software.
15726187|NCT05054816|Device|Comparator adaptive directional microphone strategy 2|A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator adaptive directional microphone strategy 2 that is used with the default settings as specified in the manufacturer's fitting software.
15726188|NCT05054816|Device|Comparator fixed directional microphone strategy|A receiver-in-canal hearing aid developed by the Study Sponsor used with the comparator fixed directional microphone strategy that is used with the default settings as specified in the manufacturer's fitting software.
15726189|NCT05054803|Drug|WJ-MSC (XCEL-UMC-BETA)|Administration of 2 Intrathecal infusions of WJ-MSC at day 1 and at 3 months
15726190|NCT05054803|Drug|Placebo|Administration of 2 Intrathecal infusions of placebo at day 1 and at 3 months
15726191|NCT05054790|Biological|"Neo-Bladder Construct"|Subjects will undergo an open full thickness bladder biopsy from which autologous urinary bladder smooth muscle and urothelial cells will be procured and expanded ex vivo. After approximately 5 - 7 weeks, expanded cells will be seeded on a biodegradable scaffold to produce the neo-bladder construct that will be surgically implanted onto an opened native bladder during an augmentation cystoplasty.
15726192|NCT05054777|Procedure|oncoplastic breast-conserving surgery|The patients received oncoplastic breast-conserving surgery, including volume displacement or volume replacement techniques
15729019|NCT05032144|Drug|Placebo|Intravenous injection
15726193|NCT05054777|Procedure|conventional breast-conserving surgery|conventional breast-conserving surgery without any oncoplastic operations
15726194|NCT05054764|Device|Promus PREMIER BTK DES|Collect one year data of the Promus PREMIER BTK drug eluting stent in CLTI patients
15726195|NCT05054751|Drug|GB491+ Fulvestrant|"GB491: The dose of GB491 is 150 mg, which should be taken with a meal and taken twice daily at approximately the same time each day, approximately 12 hours apart.
~Fulvestrant: Intramuscular injection of flurvexine 500mg on day 1 and day 15 of the first cycle, and flurvexine 500mg on day 1 of the second and subsequent cycles Flurvexine 500mg should be given slowly (1-2 minutes per injection) on both sides of the buttocks, once 250 mg on each side."
15726196|NCT05054751|Drug|Placebo+Fulvestrant|"Placebo: The dose of Placebo is 150 mg, which should be taken with a meal and taken twice daily at approximately the same time each day, approximately 12 hours apart.
~Fulvestrant: Intramuscular injection of flurvexine 500mg on day 1 and day 15 of the first cycle, and flurvexine 500mg on day 1 of the second and subsequent cycles Flurvexine 500mg should be given slowly (1-2 minutes per injection) on both sides of the buttocks, once 250 mg on each side."
15726197|NCT05054738|Behavioral|Combined Recovery Program|A six-session treatment group designed to explore goals, values, and personal strengths about making a change for overall quality of life, health and well-being combined with skill building designed for helping to live a more stable life in their own home that will include money management for financial success and home maintenance.
15726198|NCT05054738|Behavioral|Stable & Able (S&A)|A 90-day Home Telehealth program designed to help maintain skills to stay sober.
15726199|NCT05054725|Drug|RMC-4630|RMC-4630 administered orally as a capsule
15726200|NCT05054725|Drug|Sotorasib|Sotorasib administered orally as a tablet
15726201|NCT05054699|Device|Magnetic Seizure Therapy|Subjects will receive a train of magnetic pulses (between 600 and 1400 pulses) at 100Hz under general anaesthesia using a Magventure device with a Twin Coil
15726202|NCT05054699|Device|Electroconvulsive Therapy|Subjects will receive a brief-pulse electrical stimulus (between 25 and 1008mC) under general anaesthesia using a ECT device
15726203|NCT05054686|Other|Strenghthening and Aerobic Exercise Program|In this group of knee osteoarthritis patients will be applied both strengthening and 30 minutes bicycle exercises in the same session, 2 days strecthing exercises and 30 minutes walking will be given in seperate days as home program.
15726204|NCT05054686|Other|Stretching and Aerobic Exercise|In this group of knee osteoarthritis patients will be applied both stretching and 30 minutes bicycle exercises in the same session, strengthening exercises and 30 minutes walking will be given in seperate days as home program.
15726205|NCT05054686|Other|Strengthening, stretching and Aerobic Exercise|In this group of knee osteoarthritis patients will be applied all stretching, strengthening and 30 minutes bicycle exercises in the same session, only 30 minutes walking will be given as home program.
15726206|NCT05054673|Other|universal adhesive|PALFIQUE universal adhesive
15726207|NCT05054673|Other|universal adhesive|3M™ ESPE™ single bond Universal Adhesive
15726208|NCT05054660|Other|caring chatbot|The investigators will use the developed caring chatbot to provide care to the cases and to collect case treatment data and interaction data between the case and the caring chatbot.
15726209|NCT05054647|Other|psychometric questionnaires|Perceived Stress Scale (PSS-10); Trier-Inventory on Chronic Stress; State/Trait Anxiety Inventory (STAI); AVEM-Work-related behaviour and experience pattern; Maslach Burn-out Inventory - Human Services Survey (MBI - HSS) health-related anxiety: Whiteley Index (WI)
15726210|NCT05054634|Behavioral|Psycho-oncological Intervention Based on Counselling (PIBC)|Patients in EG received a psycho-oncological intervention based on Counselling (PIBC) following the scheme proposed by Arranz and Cancio in addition to the standard treatment. The evolution of anxiety and depression was evaluated using Hospital Anxiety and Depression Scale (HADS). The aim of the study was to evaluate the effectiveness of a PIBC in reducing anxiety and depression of patients with DTC. Other QoL relevant items were also evaluated using the Short Form-36 Health Survey (SF-36) and Psychological General Well-Being Index (PGWBI) scales.
15726213|NCT05054608|Other|No intervention|Observational study. No intervention.
15726214|NCT05054595|Behavioral|Standard Pain Management|Nurses will provide psychoeducation about pain along with common pain coping strategies, such as rest, ice, and elevation, for use any time they experience intense pain or take pain medication before and after surgery.
15726215|NCT05054595|Behavioral|Audio-Recorded Mindfulness-Based Intervention|Nurses will read patients a brief (1 minute) scripted, introduction to mindfulness and then have them listen to a very brief (1 minute 30 second) guided mindfulness practice validated in our prior research to encourage focused attention on breath and body sensations and open monitoring and acceptance of discursive thoughts, negative emotions, and pain. Finally, patients will be given an audio recording of the mindful pain management technique for use any time.
15726216|NCT05054595|Behavioral|Nurse-Led Mindfulness-Based Intervention|Nurses will read patients a brief (1 minute) scripted, introduction to mindfulness and then guide them through a very brief (1 minute 30 second) mindfulness practice validated in our prior research to encourage focused attention on breath and body sensations and open monitoring and acceptance of discursive thoughts, negative emotions, and pain. Finally, patients will be given an audio recording of the mindful pain management technique for use any time.
15726217|NCT05054569|Behavioral|Cognitive-Behavioral Stress Management and Health Education|Participants will attend group sessions with a trained facilitator held over videoconference. Sessions will each last 2 hours and will be held once weekly for 10 weeks. Sessions will include Cognitive-Behavioral Stress Management and health education content.
15726218|NCT05054556|Diagnostic Test|Labaratory tests|"Estimation of serum levels of the following parameters:
~galectin-3, proBNP, TNI, proGRP, CA15-3, CK, creatinine, urea, crp, pct, leucozytes"
15726219|NCT05054543|Drug|Uproleselan|A rationally designed E-selectin antagonist used to inhibit binding of cells to E-selectin
15726220|NCT05054543|Drug|Placebo|0.9% Sodium Chloride
15728127|NCT05039203|Device|Indwelling urinary catheter|Removal of indwelling urinary catheter
15726221|NCT05054530|Drug|GMA106 Injection|GMA106 solution for injection. Subjects in each cohort will receive a single injection of GMA106 or matching placebo under fasting conditions and at the following target dose levels.
15726222|NCT05054530|Drug|GMA106 Matching Placebo|Matching Placebo for GMA106
15726223|NCT05054517|Dietary Supplement|Glutamine|Oral Supplement
15726224|NCT05054504|Device|Butterfly iQ|The primary intervention under study is the Butterfly iQ point-of-care ultrasound device, embedded in a larger program of training, iterative ANC service delivery design, and a final program evaluation.
15726226|NCT05054478|Drug|Daratumumab|Daratumumab added to induction, first consolidation and second consolidation
15726227|NCT05054465|Drug|Navitoclax|P.O 50mg QD Q28 days for 2 cycles pre-transplant Up to 50mg QD Q28 days maintnance post-transplant based on MTD
15726228|NCT05054465|Drug|Venetoclax|P.O 400mg QD Q28 days for 2 cycles pre-transplant Up to 400mg QD Q28 days maintnance post-transplant based on MTD
15726229|NCT05054452|Device|Echocardiographic assessment|At baseline before standardized volume expansion, a first set of echocardiographic measurements will be performed. Then, we will perform 15-second end-expiratory and end-inspiratory occlusions. Occlusions will be separated by 1 minute to allow the cardiac index to return to its baseline value. A last set of measurements will be performed after fluid administration. Ventilatory settings and other treatments will remain unchanged during the study period.
15726230|NCT05054439|Drug|SI-B001|Administration by intravenous infusion.
15726231|NCT05054439|Drug|Paclitaxel|Administration by intravenous infusion.
15726232|NCT05054426|Drug|Methotrexate|intravenous versus intrathecal methotrexate
15726234|NCT05054400|Drug|F18 Fluciclovine|Given by IV
15726235|NCT05054400|Other|Standard of Care|Standard of care
15726236|NCT05054387|Drug|Agalsidase beta|Powder for concentration into a solution Intravenous (IV) infusion
15726237|NCT05054374|Drug|Mirdametinib|Dose Level -2INT: 2mg PO BID, 3 weeks on/1 week off Dose Level -2: 2mg PO BID given continuously Dose Level -1INT: 3mg PO BID, 3 weeks on/1 week off Dose Level -1: 3mg PO BID given continuously Dose Level 1: 4mg PO BID given continuously Dose Level 2: 6mg PO BID given continuously Dose Level 3: 8mg PO BID given continuously
15726238|NCT05054374|Drug|Fulvestrant|"The starting dose of mirdametinib in combination with fulvestrant in each Dose Level will be as follows:
~Dose Level 1: mirdametinib 4 mg BID PO + fulvestrant
~(Only to be triggered pending DLTs on higher Dose Levels as described below)
~Dose Level -2: mirdametinib 2 mg BID PO continuous + fulvestrant, and Dose Level -2INT: mirdametinib 2 mg BID PO on 3 weeks on, 1 week off + fulvestrant"
15726239|NCT05054361|Diagnostic Test|MAIT cells analysis|For FACS analysis, MAIT cells will be identified as CD3+ CD4- CD161high Vα7.2+ T cells. Surface markers will be analyzed to determine their activation status (CD25, CD69, CD44), their exhaustion (PD1, KLRG1, TIM3), their migration capacity (CCR6), and their proliferation and survival will be analyzed by Ki67 and BCL2 expression.
15726240|NCT05054361|Diagnostic Test|MAIT cytokines production analysis|Cytokine production will be assessed after PMA-ionomycin activation, followed by intracytoplasmic staining with antibodies against IL-2, IFN-γ TNF-α, IL-2, IL-4, IL-10, IL-13, IL-17 and granzyme B. To determine the capacity of MAIT cells to response to TCR stimulation (exhaustion), in vitro stimulation will be performed in the presence of specific bacterial ligands. Activation marker expression will be analyzed by FACS and cytokines released in the supernatant by Cytometry based assay.
15726241|NCT05054361|Diagnostic Test|Lactulose/Mannitol Test|After an overnight fast, the patients will drink 50 ml solution of 5 g lactulose and 2 g mannitol. Urine will be collected during before and 5 hours later.
15726242|NCT05054361|Procedure|UGI Endoscopy|Duodenal biopsy collection and analysis. Biopsies will be analyzed by qPCR for the expression of key epithelial molecules such as the fucosyl transferase 2 (fut2), tight junction proteins (occludin, claudin4), antimicrobiol peptides (Reg3, LL37) and mucus component (mucin 2). Immune cells function will also be assessed by q-PCR for key cytokines/molecules such as IL-23, IL-17, IL-22, Foxp3, IL-10, TGFb and CVB.
15726243|NCT05054361|Diagnostic Test|Coxsackie virus B infection status|Serology against CVB and CVB specific-qPCR measurement in gut microbiota samples will be performed in all patients of the three cohorts, and analysis of the gut mucosa by qPCR and immunochemistry with anti-CVB VP1 protein mAb will be performed on a subset of patients.
15726244|NCT05054361|Diagnostic Test|Coxsackie virus B infection status|Stool samples are collected and directly kept under anaerobic condition. Within an hour the samples are processed: one fraction is aliquoted and frozen at -80°C and another fraction is used to prepared fecal supernatant for the bioassay of MAIT ligands, aliquoted and frozen. Bioassay to measure the presence of MAIT cell ligands by bioassays using WT3 cell line as well as plate bound MR117. 16S sequencing of all samples and according to the results obtained with the bioassay and 16S, 10 samples will be selected for metagenomic analysis.
15726245|NCT05054348|Biological|IO-108|IO-108 given as monotherapy
15726246|NCT05054348|Biological|IO-108 + pembrolizumab combination therapy|IO-108 and fixed dose pembrolizumab combination therapy
15726247|NCT05054335|Other|Functional Assessment|Undergo walking function assessment with optical motion capture
15726248|NCT05054335|Procedure|X-Ray Imaging|Undergo bi-plane dynamic X-ray imaging
15726249|NCT05054322|Drug|Fluticasone Propionate|Fluticasone propionate added to usual care, total dose 1000 mcg per day for 14 days
15726251|NCT05054296|Behavioral|Educational Intervention|Receive general education exercise packet
15726252|NCT05054296|Behavioral|Exercise Intervention|Participate in supervised and self-directed exercise sessions
15726253|NCT05054296|Device|FitBit|Wear FitBit for activity tracking
15726254|NCT05054296|Other|Quality-of-Life Assessment|Ancillary studies
15726255|NCT05054296|Other|Questionnaire Administration|Ancillary studies
15726317|NCT05053724|Other|Star to move Protocol|"Progressive physical therapy according to the Gosslink protocol called Start to move."
15726256|NCT05054283|Diagnostic Test|Inflamatory biomarkers|laboratuary parameters of within 24 hours of admission (levels of white blood cell (WBC), lymphocyte neutrophil, hemoglobin (Hb), platelet, fasting glucose, glycated hemoglobin, aspartate aminotransferase (AST) , c-reactive protein (CRP), ferritin, and procalcitonin) were recorded from medical records and collected by two trained fellow geriatricians.
15726257|NCT05054270|Other|Chest examination with Ultrasound device|Chest examination with Ultrasound device
15726258|NCT05054257|Drug|Autologous CAR19 T lymphocytes|First-in-human trial examining the safety and efficacy of CART19 in r/r B-ALL and B-NHL
15726259|NCT05054244|Other|standard wound treatment|Standard treatment includes dressings, debridement, antibiotics, and bacterial load relief. The dressing will be performed according to wound characteristics with change every two days including primary dressing (alginates, hydrofiber dressing, antimicrobial dressing, gelling fiber dressing), with silver if infected, and secondary protective dressing (foam with polyurethane) in wounds with formed granulation tissue. The progression of the wound and the need for specific treatment will be evaluated weekly by dermatologist and vascular surgeon specializing in wound care, and appropriate treatment conducted according to wound assessment (antibiotics, bandage, dressing change, debridement, amputations).
15726260|NCT05054244|Procedure|Hyperbaric oxygenation (HBOT)|The HBOT sessions will be performed 5 days a week, in multi-place chamber at 2.4 atm absolute (ATA) and 100% O2 with effective treatment lasting for 90 min. The sessions will be supervised by doctors trained in hyperbaric medicine.
15726261|NCT05054231|Other|Blood sample collection|Blood samples collection: at Day (D)-6 and D0 before CAR-T cells injection, post injection at Day (D)3, D5,D7, D9, D11, D14, D18, D 21, Month 2 and Month 12 post injection.
15726262|NCT05054218|Biological|mRNA-1273|Participants will receive a 0.5 mL injection of the vaccine that contains a 100-μg dose of mRNA1273. The vaccine will be administered into the deltoid muscle.
15726263|NCT05054205|Behavioral|Motivational İnterviewing|"The most current version of Motivational İnterviewing (MI) is described in detail in Miller and Rollnick (2013) Motivational Interviewing: Helping people to change (3rd edition). Key qualities include:
~MI is a guiding style of communication, that sits between following (good listening) and directing (giving information and advice).
~MI is designed to empower people to change by drawing out their own meaning, importance and capacity for change.
~MI is based on a respectful and curious way of being with people that facilitates the natural process of change and honors client autonomy."
15726264|NCT05054179|Drug|Ropivacaine 0.2% Injectable Solution|20 mL of ropivacaine 0.2% will be injected via parasternal multi-orifice catheters on each side, followed by infusion of 3 mL/h for 48 hours after Sternotomy.
15726265|NCT05054179|Other|Saline|20 mL of saline will be injected via parasternal multi-orifice catheters on each side, followed by infusion of 3 mL/h for 48 hours after Sternotomy.
15726266|NCT05054166|Other|No intervention, it was a retrospective study.|This study aimed to retrospectively investigate the efficacy of the everolimus-containing chemotherapy in metastatic breast cancer patients with PI3K/AKT/mTOR mutations.There was no intervention.
15726272|NCT05054127|Other|foiiow up patients|observational study
15726273|NCT05054114|Drug|Interferon gamma human recombinant (IFN-G)|nasal form
15726274|NCT05054101|Other|Real-time assessment using the VieCovid2020 smartphone application|a real-time assessment using the VieCovid2020 smartphone application during the first 3 months in add-on to usual psychiatric intervention
15726276|NCT05054075|Biological|Marine liquid and fluids|Marine liquid and fluids extracted from freshwater bivalve of A. cygnea (under very specific conditions)
15726277|NCT05054075|Biological|Impregnation|SARS / COVID-19 fluid/liquid - impregnation
15726278|NCT05054075|Biological|Incubation|SARS / COVID-19 fluid-bivalve-incubation
15726279|NCT05054075|Biological|Manipulation|Bivalve Manipulation - Stress inducing
15726280|NCT05054075|Biological|Refrigeration|Refrigerated fluid to check for maintained response
15726281|NCT05054062|Diagnostic Test|Sentinel node mapping using MRI|Sentinel lymph node mapping in melanoma patients using a magnetic tracer and MRI
15726282|NCT05054049|Device|Interventional Diagnostic Device Arm|Point of care testing venous blood diagnostic device.
15726283|NCT05054049|Other|Usual care|Usual care provided to patient without use of point of care testing device
15726284|NCT05054036|Drug|MoviPrep|Split-dose MoviPrep bowel preparation
15726285|NCT05054036|Drug|Golytely|Split-dose GoLYTELY bowel preparation
15726286|NCT05054023|Drug|Soulagel®|topic gel
15726287|NCT05054023|Drug|Arthrosyl®|topic gel
15726316|NCT05053737|Radiation|Stereotactic Body Radiation Therapy|SBRT will be given 3 times on non-consecutive days over the course of 5 to 7 days. Radiation will target sites of gross disease only to minimized exposure to normal tissue.
15726369|NCT05053373|Device|Sham electroacupuncture group|
15726288|NCT05053997|Behavioral|NAVIGATE|Patients' symptoms are systematically monitored by use of bi-weekly patient reported outcomes and nurse navigators will initiate appropriate actions in terms of medical treatment or guidance of self-management strategies. Nurse navigators will motivate and support patients in health behavior changes and in selfmanaging their treatment and symptoms, and, if relevant, refer to existing rehabilitation services at the hospital or at the local rehabilitation center. Physiotherapists will supervise a training program aimed at improving patients' physical function and thus potentially surgery and overall treatment adherence and outcomes.
15726289|NCT05053984|Procedure|Percutaneous Echoguided Neuromodulation|Once the nerve is located, a needle is introduced in the vicinity of the nerve and is stimulated using an electrical current with a frequency of 10 Hz, with a pulse width of 250 µs and a tolerable intensity causing a visible muscle contraction for 1.5 minutes.
15726290|NCT05053971|Drug|BET Bromodomain Inhibitor ZEN-3694|Given PO
15726291|NCT05053971|Drug|Entinostat|Given PO
15726292|NCT05053958|Other|superimposition of DICOM file from CBCT and STL file of Intraoral scanner|These files will be imported in implant planning software,and virtual implant planning will be performed.
15726293|NCT05053945|Diagnostic Test|Esophagogastroduodenoscopy|"To set up a prospective study and registry (HAR-P) for patients with H. pylori infection, atrophic gastritis or intestinal metaplasia to evaluate their clinical features and outcomes. The objectives include:
~Assess the short- and long-term patient outcomes of H. pylori patients
~Characterize factors involved in the progression or regression of pre-neoplastic lesions, namely atrophic gastritis and intestinal metaplasia
~Gather information for a better understanding on the efficacy and role of surveillance
~Potential for the development of new screening/surveillance strategies and tools for better risk stratification of patients
~Establish a biobank for H. pylori, atrophic gastritis and intestinal metaplasia patients"
15726294|NCT05053932|Other|blood collection|blood collection
15726295|NCT05053919|Device|Schumann resonance sleep device|"A Schumann resonance sleep device would stably output the composite frequency of a the Schumann resonance frequency (7.83 Hz) wave, theta wave, and delta wave.
~The subjects were asked to use the device (place it next to the bed facing the subject's head, turn it on about one hour before going to bed every night, and turn it off after getting up the next day) every night for four weeks."
15726296|NCT05053919|Device|Placebo sleep device|"A Placebo sleep device is an instrument with the same appearance and operation as the Schumann resonance sleep device, but does not output any frequency wave.
~The subjects were asked to use the device (place it next to the bed facing the subject's head, turn it on about one hour before going to bed every night, and turn it off after getting up the next day) every night for four weeks."
15726297|NCT05053906|Device|Endoscope|effect of FESS on eustachian tube function
15726298|NCT05053893|Drug|Roxadustat;Sacubitril Valsartan Sodium Tablets;|Select the appropriate dose according to the patient's situation
15726299|NCT05053893|Drug|EPO; ACEI / ARB|Select the appropriate ACEI /ARB according to the subject's situation or follow its previous medication
15726304|NCT05053854|Drug|Talazoparib|During dose escalation, doses of talazoparib that can be administered are 0.1mg, 0.25mg, 0.5mg or 1mg oral daily. Talazoparib will be given on days 2-6 of each cycle of 177Lu-DOTA-Octreotate for cycles 2-4, every 8 weeks
15726305|NCT05053841|Drug|Metformin|
15726306|NCT05053828|Drug|Antiplatelet Drug|Antiplatelet drugs and agents
15726307|NCT05053815|Other|Pharmacogenomic Testing|Pharmacogenomic testing is done via buccal swab. As this study is retrospective, data from PGx testing has already been collected as a part of routine care.
15726308|NCT05053802|Combination Product|Microwave ablation plus Camrelizumab|Tumor received treatment of microwave ablation and received no more than 16 cycles of Camrelizumab
15726309|NCT05053802|Device|Microwave ablation|Tumor received treatment of microwave ablation
15726310|NCT05053789|Device|Lacrimera|A new preservative-free formulation of eye drops consists of a novel biopolymer, chitosan-N-acetylcysteine (C-NAC; Lacrimera®, Croma-Pharma GmbH, Leobendorf, Austria), which electrostatically binds to the mucine layer of the tear film forming a glycocalyx-like structure.
15726311|NCT05053789|Device|Hylo-Vision|Preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine).
15726312|NCT05053763|Drug|Remimazolam|The study was carried out using a biased coin design up-and-down sequential method, where the dose of remimazolam administered to each patient depended on the response of the previous one with success/failure duodenoscopy insertion during ERCP are required for reliable estimates. The first patient was tested at 0.2mg/kg remimazolam (0.025mg/kg as a step size). Duodenoscopy insertion was conducted when MOAA/S≤1.The response of the patients to the duodenoscopy insertion during ERCP was categorized as either 'success (no movement)' or 'failure (movement). if a patient had a failure duodenoscopy insertion, the dose of remimazolam was increased by 0.025mg/kg in the next subject. If a patient had a successful duodenoscopy insertion the next subject was randomised to receive either a lower dose (with a decrement of 0.025mg/kg), with a probability of b = 0.11, or the same dose, with a probability of 1-b = 0.89.
15726313|NCT05053750|Drug|Paclitaxel/Bev (control)|Given by PO
15726314|NCT05053750|Drug|Paclitaxel/Bev + ZA (experimental)|Given by PO
15726315|NCT05053737|Drug|Atezolizumab|Participants will receive atezolizumab administered by intravenous (IV) infusion at a fixed dose of 1200 mg. Two doses will be given separated by 21 days (second dose can be given at at 21 + 7 -10 days).
15726370|NCT05053373|Behavioral|Pelvic floor muscle training|
15726324|NCT05053698|Other|Aqueous flare measurement|Aqueous flare was measured preoperatively and postoperatively with a laser flare-cell meter (LFCM ; Kowa FM-500, Kowa Company Ltd, Tokyo, Japan).
15726325|NCT05053685|Diagnostic Test|Measurement of Urine and plasma metanephrines|Measurement of Urine and plasma metanephrines
15726326|NCT05053672|Device|ReOxy|"ReOxy therapy is a protocol which employs passive (the patient is at rest), short (up to 10 min) mild normobaric hypoxic exposures alternated with similar duration intervals of breathing hyperoxia (up to 5 min). The gas mixtures are supplied to a patient via facial mask on continued measuring of oxygenation status of the patients, lasting about 45 min in total per treatment session.
~The hypoxic load will be individually adjusted, based on the results of a preliminary hypoxic test. The patient inhales air with low oxygen content (10-14%) at atmospheric pressure in a continuous mode through a mask withing 10-min.
~During the ReOxy - treatment session, the software automatically adjusts the gas mixture switching, based on changes in physiological parameters (blood oxygen saturation and heart rate) in response to hypoxic and hyperoxic impact (biofeedback control)."
15726327|NCT05053672|Device|Sham ReOxy|Placebo treatment with 'sham' ambient air breathing to simulate ReOxy-therapy sessions. Placebo-mode breathing set visually similar to standard breathing set but have a mask with open intake valve. The masks are chosen in a way to provide maximum degree of similarity to reduce the risk of unblinding on the patient-side.
15726328|NCT05053659|Drug|Loncastuximab tesirine|Loncastuximab tesirine 50 - 150 μg/kg will be administered as a 30 minutes IV infusion on Day 1 of each cycle for 6 cycles. On doses over 100 μg/kg, subsequent dosing (i.e. beyond 100 μg/kg) will be done at 50% of the dose that is administered on the first 2 cycles.
15726329|NCT05053659|Drug|Venetoclax|"Participants will receive venetoclax at target doses of 400 - 800mg orally on days 1 - 5 of each (21 day) cycle.
~On cycle 1, venetoclax dose will be escalated to reach the target dose over the course of 5 days for target dose 400mg, 6 days for target dose 600mg and 7 days for target dose 800mg
~Venetoclax should preferably be given after a meal and on cycle 1 should be preceded by prophylaxis for tumor lysis syndrome (TLS)."
15726330|NCT05053646|Procedure|Meniscal repair|The meniscus is trimmed with an arthroscopic punch followed by an electric shaver to expose the margins of the tear and remove damaged tissue. Vertical sutures are made using TRUESPAN™ Meniscal Repair System (DePuy Synthes) to approximate both the femoral and tibial surfaces of the torn meniscus.
15726331|NCT05053646|Procedure|Marrow venting procedure|After meniscal repair, a bone marrow venting procedure will be performed: a 45° micro-fracture awl is repeatedly penetrated through the bone of the intercondylar notch at the PCL origin until marrow elements are seen to enter the joint.
15726332|NCT05053633|Procedure|Combined spinal epidural anesthesia|Apply combined spinal epidural anesthesia
15726333|NCT05053620|Device|Calculation of the arcuate intrasomal incisions|All patients participating in the study will undergo femtosecond laser treatment for the correction of astigmatism through arcuate intrastromal incisions with the Catalys laser (Johnson & Johnson, USA, CE marked). The calculation of intrastromal arcuate incisions will be carried out using the following nomogram indicated on the laser: 9.0 mm optical zone and symmetrical incisions of 50 degrees for 0.50D, 55 degrees for 0.75D, 60 degrees for 1.00D and 65 degrees for 1.25D of corneal astigmatism. After the incisions, conventional cataract surgery will be performed using the Centurion phacoemulsifier equipment (Alcon, USA, with CE marking) in the ZCB00 monofocal intraocular lens (IOL) implant (Johnson & Johnson, USA, with CE marking). All patients will be treated according to standard clinical practice.
15726334|NCT05053607|Behavioral|Digital Health Coaching Program|consisting of weekly calls and delivery of evidence-based content across health and wellness domains (e.g. nutrition, exercise, physical, emotional and financial health) up to 4 times weekly via text, email or mobile application.
15728128|NCT05039190|Drug|HBM9161 Injection (680mg)|HBM9161 Injection
15726335|NCT05053607|Device|Fitbit|A wrist-worn activity tracker allowing for the capture of physical activity, including but not limited to step-count and minutes of activity, to be captured daily.
15726336|NCT05053594|Drug|Neostigmine 10 mcg/kg|Once the third response to TOF is obtained, neostigmine 10 mcg/kg will be administered
15726337|NCT05053594|Drug|Neostigmine 20 mcg/kg|Once the third response to TOF is obtained, neostigmine 20 mcg/kg will be administered
15726338|NCT05053594|Drug|Neostigmine 30 mcg/kg|Once the third response to TOF is obtained, neostigmine 30 mcg/kg will be administered
15726339|NCT05053594|Other|Placebo|Once the third response to TOF is obtained, saline will be administered
15726340|NCT05053581|Other|Survey|Patients will complete 7 questionnaires at inclusion (T0) and 1,3 and 6 months after start of CPAP treatment
15726341|NCT05053568|Device|CARTBox|CARTBox performs analysis of cardiac MRI scans. The result is a treatment file that displays optimal targets for left ventricular lead implantation in CRT. This file will be used as an overlay with live fluoroscopy during the implantation procedure in the intervention group.
15726342|NCT05053555|Device|high dose rate brachytherapy|diagnostic workup, staging, and treatment per the institution standard of care
15726343|NCT05053555|Device|high dose rate brachytherapy|reviewing historical patients who meet the above criteria for group A but did not receive HDRBT between 01/01/2000 and 1/01/2021
15726344|NCT05053542|Procedure|Enema|Patients in the PBP group underwent a cleansing enema procedure with a solution of monosodium phosphate and disodium phosphate (EVAC enema 118 mL/bot, Purzer Pharmaceutical Co., Ltd) before hemorrhoidectomy, whereas patients in the non-PBP group skipped the procedure.
15726345|NCT05053529|Other|Mirror therapy|Session consist of total 1hour,20 min of passive mobilization, 30 minutes for Movement mirror therapy,10 minutes standard ADL activities 5 times a week and for consecutive 3 weeks in a month.
15726346|NCT05053529|Other|CIMT group|Session consist of total 1hour ,20 min of passive mobilization, 30 min session to CIMT and 10 minutes standard ADL activities 5 times a week and for consecutive 3 weeks in a month.
15726347|NCT05053516|Other|A standardized training program for social workers|A standardized training program for social workers who work with drug addicts / drug users based on industry needs
15726348|NCT05053503|Device|Sparrow Therapy System|Transcutaneous auricular neurostimulation
15726349|NCT05053503|Drug|Lofexidine|Participants will receive lofexidine based on the clinical site's standard of care.
15726350|NCT05053503|Drug|Naltrexone Injection|Participants will receive depot naltrexone based on the clinical site's standard of care.
15726353|NCT05053477|Drug|mehylprednisolone injection|(40 mg)
15726354|NCT05053477|Device|pulsed radiofrequency (PRF)|. PRF lesion will be carried out for 120 seconds at a 2 Hz frequency and pulse width of 20 ms at 42°C
15726355|NCT05053477|Biological|platelet-rich plasma|2 ml of PRP
15726356|NCT05053451|Device|Transcranial Direct Current Stimulation|In tDCS, saline-soaked electrodes are temporarily affixed to the scalp and connected to a battery-powered current generator. A weak (2 mA) constant current is then briefly applied (20 minutes) to stimulate the targeted brain area (e.g. the DLPFC, TPJ, Occipital Cortex) depending on the phase of the study.
15726357|NCT05053438|Behavioral|Intensive Multidisciplinary Feeding Intervention (IMFI)-Standard of Care|"Standard care involves behavioral intervention delivered during admission Intensive Multidisciplinary Intervention. Patients admitted to the program will participate in four therapeutic meals per day, five days per week (Monday through Friday). The behavioral intervention involves a standard sequence of reinforcement techniques, bite persistence (a.k.a., contingency contacting, escape extinction), and stimulus fading/antecedent manipulation protocols. Parent training will be the central method for structuring meals and transferring treatment gains from the clinic to the home setting. The sequence and steps for parents training will follow a sequential, proficiency-based process, with caregivers transitioning to serve as the primary feeder by discharge.
~Management of tube wean in our standard of care involves reducing tube feeding calories based on oral intake at a 1:1 ratio."
15726358|NCT05053438|Behavioral|Intensive Multidisciplinary Feeding Intervention (IMFI) standard of care + rapid tube weaning|The experimental arm combines standard care with a rapid tube wean. On day 1, the dietitian will meet with the caregiver to determine the usual tube feeding schedule. The dietitian will then create a tube feeding plan that meets 70% of the child's caloric needs (a 30% reduction).On day 3, if a patient has moved past a rice size bite volume in therapeutic meals, the patient's tube feedings will be further reduced to meet 50% of needs. All schedules and documents will be updated accordingly. After the 50% tube wean cut, the dietitian will use a regular tube wean sheet to provide credit for oral intake for the remainder of admission.
15726359|NCT05053425|Drug|Venetoclax|given po.
15726360|NCT05053425|Drug|Azacitidine|given sc.
15726361|NCT05053425|Drug|Cladribine|given ivgtt.
15726362|NCT05053425|Drug|Cytarabine|given sc or ivgtt.
15726363|NCT05053425|Drug|Idarubicin|given ivgtt.
15726364|NCT05053412|Diagnostic Test|Helio Liver Test|A Helio Liver Test is used as the basis of performance evaluation for specificity and sensitivity for all patients enrolled in the study.
15726365|NCT05053399|Device|Model Series ZXT|Investigational intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
15726366|NCT05053386|Drug|Idarubicin Hydrochloride for Injection|After an interventional treatment, CT and/or MRI, tumor-related markers, liver and kidney function and blood routine examinations will be reviewed every 4-6 weeks, based on the patient's response to the last treatment, changes in liver function and physical fitness, and CT And (or) dynamic enhanced MRI scan to evaluate the survival of liver tumors and determine the next TACE treatment. At least 2 cycles are applied and no more than 4 cycles are applied.
15726367|NCT05053386|Drug|Epirubicin|After an interventional treatment, CT and/or MRI, tumor-related markers, liver and kidney function and blood routine examinations will be reviewed every 4-6 weeks, based on the patient's response to the last treatment, changes in liver function and physical fitness, and CT And (or) dynamic enhanced MRI scan to evaluate the survival of liver tumors and determine the next TACE treatment. At least 2 cycles are applied and no more than 4 cycles are applied.
15726368|NCT05053373|Device|Electroacupuncture group|
15726371|NCT05053360|Behavioral|Healing Touch|"Healing Touch (HT), with a foundation in holistic nursing, is a gentle therapy that uses touch to promote health and well-being by balancing the human energy system. Healing Touch (HT) is a biofield therapy in which practitioners use their hands in a heart-centered and intentional way to provide energetic balance to support physical, emotional, mental and spiritual health. It is safe for all ages and works in harmony with, is complementary to, and may be integrated with standard medical care. Healing Touch is a collection of standardized, noninvasive techniques that clear, energize, and balance the human and
~environmental energy fields."
15726372|NCT05053360|Other|Control|Quiet Time (QT) session is when a subject is provided with quiet for 15 minutes
15726373|NCT05053347|Dietary Supplement|Bread fortified with ALA|The participants were asked to take baked bread once a day. The intervention period is about 6 months separated by a two-month washout period. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.
15726374|NCT05053347|Dietary Supplement|Bread without ALA|The participants were asked to take baked bread once a day. The intervention period is about 6 months separated by a two-month washout period. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.
15726375|NCT05053334|Drug|Omalizumab Prefilled Syringe|150mg/ml of Omalizumab prefilled syringe
15726376|NCT05053321|Drug|Valbenazine|All participants will be treated with Valbenazine for 7 weeks.
15726377|NCT05053308|Drug|Intravenous Infusion|IV PCA(fentanyl) Fentanyl bolus = MME * 15%
15726378|NCT05053308|Drug|Sublingual Tablet|subligual fentanyl(Narco®) Fentanyl 100mcg/200mcg/300mcg according to the around-the-clock opioid requirement.
15726379|NCT05053295|Drug|autologous activated T lymphocyte|"Drug: Immuncell-LC IV
~Drug: Nivolumab (Opdivo®) IV"
15726380|NCT05053282|Other|endurance running exercise|regular competitive or non-competitive running of medium and/or high intensity with the duration at least 20 minutes per session
15726381|NCT05053269|Other|good body weight growth|body weight growth after birth is consistent with the growth curve
15726382|NCT05053269|Other|poor body weight growth|body weight growth after birth is inconsistent with the growth curve
15726383|NCT05053243|Device|Kardia 12L|The purpose of this study is to collect clinical validation data to support an FDA submission for a 510(k) for the Kardia 12L hardware which enables the simultaneous diagnostic quality recording of all 6 limb leads and any chest lead. We will be recording both Leads V2 and V4 in a sequential fashion along with the Limb leads and a simultaneous 12-lead ECG to validate the hardware and a Deep Neural Network model which expands the 7 leads into a complete 12-lead ECG. The 12-lead ECG used for validation of the recordings and the 12-lead synthesis model is the GE Cardiosoft System which is FDA cleared.
15726384|NCT05053230|Behavioral|IM@Home|"Participants will be enrolled into either IM@Home or enhanced usual care prior to or within 2 weeks at the start of their systemic therapies for the study duration of 12 weeks.
~IM@Home is an online mind-body program consisted of a series of virtual, synchronous classes that offer a variety of rigorously tested mind-body therapies led by an Integrative Medicine Service (IMS) clinical therapist. The virtual mind-body group therapy sessions will be conducted using Zoom video conferencing platform."
15726385|NCT05053230|Behavioral|Enhanced usual care|Patients in the enhanced usual care will receive usual care. In addition, once enrolling into the trial, they will be given a handout to encourage them to visit the MSK's multimedia page on the Integrative Medicine website to access pre-recorded, on-demand meditation videos/audios
15726386|NCT05053217|Procedure|transforaminal epidural steroid injection|In the transforaminal approach, a small amount of drug is injected into the epidural space, and in previous studies, reduction in pain and improvement in functionality were found in patients with lumbar radicular pain in the short and medium term.
15726387|NCT05053191|Behavioral|Partnership, Assessment, Care and Transition training intervention|Partnership, Assessment, Care and Transition to psychosocial resources. Nurses who participate in PACT will receive 8 hours of training in a single, full-day workshop. We will train nurses in clusters of 10-12 nurses at one time, which will allow for cross-coverage with minimal disruption to workflow, and provide a more intimate, small-group learning environment.
15726388|NCT05053178|Behavioral|Mindfulness-based mandala activity|Mindfulness-based mandala activity was applied to the intervention group via the zoom online program. Students will be divided into groups of 6-10 and mandala activities will be carried out. 3 weeks of mandala activity, breathing exercises, affirmations, etc. a therapeutic application program was created and implemented
15726389|NCT05053165|Drug|LB-P6|Healthy subjects will be randomized to receive LB-P6 once daily orally
15726390|NCT05053165|Drug|LB-P8|Healthy subjects will be randomized to receive LB-P8 once daily orally
15726391|NCT05053165|Drug|Placebo|Healthy subjects will be randomized to receive placebo once daily orally
15726392|NCT05053152|Drug|Placebo Administration|Given PO
15726393|NCT05053152|Other|Quality-of-Life Assessment|Ancillary studies
15726394|NCT05053152|Drug|Relugolix|Given PO
15726395|NCT05053152|Radiation|Stereotactic Body Radiation Therapy|Undergo SABR
15726397|NCT05053126|Drug|Pregabalin 300mg|Participant will receive an oral dose of pregabalin 300 mg
15726398|NCT05053126|Drug|pregabalin 450 mg|Participant will receive an oral dose of pregabalin 450 mg
15726399|NCT05053126|Drug|Pregabalin 300 mg with oxycodone 20 mg|Participant will receive an oral dose of pregabalin 300 mg and oxycodone 20 mg
15726400|NCT05053126|Drug|pregabalin 450 mg with oxycodone 20 mg|Participant will receive an oral dose of pregabalin 450 mg and oxycodone 20 mg
15726401|NCT05053126|Drug|oxycodone 20 mg|Participant will receive an oral dose of oxycodone 20 mg
15726402|NCT05053126|Drug|Placebo|Participant will receive an oral dose of placebo
15726403|NCT05053113|Device|Activity Monitor|Monitor physical activity with FitBit
15726404|NCT05053113|Device|Activity Monitor|Wear accelerometer
15726405|NCT05053113|Other|Educational Intervention|Receive educational newsletter
15726406|NCT05053113|Other|Survey Administration|Ancillary studies
15726407|NCT05053113|Behavioral|Telephone-Based Intervention|Receive phone call from health coach
15726408|NCT05053100|Procedure|Biospecimen Collection|Undergo collection of blood
15726409|NCT05053100|Other|Electronic Health Record Review|Undergo electronic health record review
15726413|NCT05053074|Device|Nasal High Flow (NHF)|Patients with chronic respiratory failure are treated for 1 h with NHF therapy and with individual O2 supplementation during wakefulness.
15726414|NCT05053061|Behavioral|Application program for pulmonary rehabilitation|Exercise videos for pulmonary rehabilitation
15726415|NCT05053048|Device|SL-PLUS-Stem for total hip arthroplasty|Patients undergoing primary total hip arthroplasty are randomly assigned (1:1) to receive either an uncemented NT-SL-PLUS Stem (Smith&Nephew Orthopaedics AG, Aarau, Switzerland) or a matching uncemented STD-SL-PLUS stem (Smith&Nephew Orthopaedics AG, Aarau, Switzerland) in a blinded fashion.
15726416|NCT05053035|Drug|AL001|Administered via intravenous (IV) infusion
15726417|NCT05053035|Drug|Placebo|Administered via intravenous (IV) infusion
15726418|NCT05053022|Device|Skinpen Precision System|Subjects will receive a total of 8-12 treatments with the Skinpen Precision system targeting their Vitiligo lesions.
15726419|NCT05053009|Drug|Brufen Retard|800 mg tablet of Brufen Retard will be adminstered orally one hour before local anesthesia
15726423|NCT05052983|Drug|Nemolizumab|Participants will receive either 1 [30 milligram (mg)] or 2 (2×30 mg) subcutaneous injection(s) of nemolizumab every 4 weeks (Q4W) for a period of 24 weeks (with last injection at Week 20). Participants will receive the same dosage (1 or 2 SC injections) as received in the lead-in LTE study RD.06.SPR.202699, as assigned by interactive response technology (IRT).
15726424|NCT05052983|Drug|Placebo|Participants will receive either 1 (30 mg) or 2 (2x30 mg) subcutaneous injection(s) of placebo every 4 weeks for a period of 24 weeks (with last injection at Week 20). Participants will receive the same dosage (1 or 2 SC injections) as received in the lead-in LTE study RD.06.SPR.202699, as assigned by IRT.
15726425|NCT05052970|Drug|Mitoxantrone Hydrochloride Liposome injection|Mitoxantrone Hydrochloride Liposome injection will be administered by an intravenous infusion on day 1 of each 28-day cycle
15726426|NCT05052970|Drug|Bortezomib for Injection|Bortezomib (1.3 mg/m^2) will be administered by an intravenous injection or subcutaneously on day 1,4,8,11of each 28-day cycle
15726427|NCT05052970|Drug|Dexamethasone Acetate Tablets|Dexamethasone (20 mg/d) will be taken orally on day 1,2,4,5,8,9,11,12 of each 28-day cycle
15726428|NCT05052957|Biological|P140K-MGMT|Ex Vivo Cultured P140K MGMT CD34+ Cells. The transduced cells are a biological product and production is detailed in the Cellular Therapy Lab standard operating procedures and IND 14099
15726429|NCT05052957|Drug|O6-benzylguanine|O6BG is a low molecular-weight purine analog which selectively and irreversibly inactivates the DNA-repair enzyme, O6- alkylguanine DNA-alkyltransferase.
15726430|NCT05052957|Radiation|Photon Based Radiotherapy|Standard of care, photon-based radiotherapy (60Gy in 30 fractions) will be performed in both arms without concomitant TMZ between to 6 weeks post-operatively. Radiotherapy will be performed at both UH-SCC or NIH-CC.
15726431|NCT05052957|Drug|temozolomide|Temozolomide is not directly active but undergoes rapid non-enzymatic conversion at physiologic pHto the reactive compoundMTIC. The cytotoxicity of MTIC is thought to be primarily due to alkylationof DNA. Alkylation (methylation) occurs mainly at the O6 and N7 positions of guanine
15726432|NCT05052957|Drug|Filgrastim|Filgrastim is a 175 amino acid protein manufactured by recombinant DNA technology. Endogenous filgrastim is a glycoprotein produced by monocytes, fibroblasts, and endothelial cells, which regulates the production of neutrophils within the bone marrow.
15726433|NCT05052957|Drug|carmustine|BCNU is a lipid soluble agent which has alkylating properties, plus an isocyanate metabolite which interferes with DNA and RNA synthesis.
15726434|NCT05052944|Device|Cochlear implantation|Patients who receive cochlear implant for single-sided deafness
15726435|NCT05052931|Drug|Nab-paclitaxel combined with oxaliplatin and S-1|Nab-paclitaxel 100mg/m^2, D1, Q3W; oxaliplatin 85 mg/m^2, D1, Q3W; S-1 60 mg/m^2, D1-14, Q3W; Neoadjuvant chemotherapy 2 cycles, followed by surgery, continue to receive 6 cycles of adjuvant chemotherapy.
15726436|NCT05052918|Behavioral|Exercise|1 hour of moderate-intensity aerobic exercise 3 days a week for 12 weeks
15726437|NCT05052905|Device|LibraVR|"LibraVR is a standalone VR-based rehabilitation software for use in physiotherapy. It is designed to work with standard off-the-shelf hardware that is tested and approved for use in conjunction with the software.
~LibraVR system consists of the software (LibraVR Clinic) running on a PC (database of patients, creation of protocols, uploading protocols to mobile), and the LibraVR Mobile APP that runs on commercial mobile smartphones embedded in a lightweight cardboard or plastic VR viewer that the child wears as they would eyeglasses. The software displays a range of immersive VR exercises."
15726438|NCT05052892|Diagnostic Test|Hepatic venous pressure gradient|All patients underwent measurement of HVPG under local anesthesia.
15726439|NCT05052879|Drug|Toronto association|Toronto association coated tablet, 20 mg + 30 mg or 20 mg + 60 mg, oral, 2 hours before the sexual intercourse.
15726440|NCT05052879|Drug|Tadalafil|Tadalafil coated tablet, 20 mg, oral, 2 hours before the sexual intercourse.
15726441|NCT05052879|Other|Tadalafil placebo|Tadalafil placebo coated tablet, oral, 2 hours before the sexual intercourse.
15726442|NCT05052879|Other|Toronto association placebo|Toronto association placebo coated tablet, oral, 2 hours before the sexual intercourse.
15726443|NCT05052866|Behavioral|Social Robot|Participants will interact with a social robot companionbot for a period of 8-10 weeks. The robot will stay in participants' apartments.
15726444|NCT05052853|Drug|NMDAE|Use of an NMDA enhancer for the treatment of prodromal schizophrenia .
15726445|NCT05052853|Drug|Placebo Cap|Use of placebo as a comparator
15726446|NCT05052840|Other|Muscle endurance training (MET)|Experimental group will be given MET Program, stretching & strengthening exercises and Hot packs (for 15 minutes). MET program will include warm up, endurance and cool down exercises. The warm up and cool down period will be consisted of 5-minute walking, and 10 repetitions of stretching exercises. Endurance exercises will consist of 4 levels.
15726447|NCT05052840|Other|Conventional Treatment|"Conventional treatment group will be given hot packs (for 15 minutes) and Strengthening & stretching exercise program including:
~STRETCHING EXERCISES (lumbar extensor muscles, iliopsoas muscles, hamstring muscles, gastrocnemius muscles and pectoral muscles).
~STRENGTHENING EXERCISES (rectus abdominus crunch, oblique crunch, pelvic elevation, single leg pelvic elevation, lumbal spine extension, on hands and knees position with the raise of one leg, on hands and knees position with the raise of opposite arm and leg). Each exercise will be repeated 10 times."
15726448|NCT05052827|Dietary Supplement|Milk Protein Concentrate|"Protein provided at 0.35 g/kg fat free-mass. Macronutrient and Amino Acid Content provided below.
~Per 100 g protein powder:
~Calories (Cal): 363 Carbs (g): 5.60 Protein (g): 82.60 Fat (g): 1.12 Total BCAA (g): 15.67 Total EAA (g): 34.66 Total AA (g): 83.27"
15726449|NCT05052827|Dietary Supplement|Rice Protein Isolate|"Protein provided at 0.35 g/kg fat free-mass. Macronutrient and Amino Acid Content provided below.
~Per 100 g protein powder:
~Calories (Cal): 394 Carbs (g): 6.50 Protein (g): 86.70 Fat (g): 2.39 Total BCAA (g): 14.98 Total EAA (g): 30.62 Total AA (g): 86.11"
15726450|NCT05052827|Dietary Supplement|Soy Protein Isolate|"Protein provided at 0.35 g/kg fat free-mass. Macronutrient and Amino Acid Content provided below.
~Per 100 g protein powder:
~Calories (Cal): 377 Carbs (g): 2.12 Protein (g): 88.8 Fat (g): 0.60 Total BCAA (g): 13.88 Total EAA (g): 31.74 Total AA (g): 89.39"
15726451|NCT05052814|Other|root canal medicament-calcium hydroxide|Two different root canal medicaments and their combination were placed into the root canals following the removal of previous root canal fillings and re-instrumentation. Afterward, postoperative pain scores were recorded at 6 and 12 hours and at 1, 2, 3, 4, 5, 6, and 7 days using the visual analog scale (VAS). Sensitivity on percussion, spontaneous pain, swelling, and antibiotic and analgesic requirements of the patients were married during clinical examinations performed postoperatively after 2 and 7 days.
15726452|NCT05052814|Other|root canal medicament-chlorhexidine gel|Two different root canal medicaments and their combination were placed into the root canals following the removal of previous root canal fillings and re-instrumentation. Afterward, postoperative pain scores were recorded at 6 and 12 hours and at 1, 2, 3, 4, 5, 6, and 7 days using the visual analog scale (VAS). Sensitivity on percussion, spontaneous pain, swelling, and antibiotic and analgesic requirements of the patients were married during clinical examinations performed postoperatively after 2 and 7 days.
15726453|NCT05052814|Other|root canal medicament-calcuim hyroxide &chlorhexidine ge|Two different root canal medicaments and their combination were placed into the root canals following the removal of previous root canal fillings and re-instrumentation. Afterward, postoperative pain scores were recorded at 6 and 12 hours and at 1, 2, 3, 4, 5, 6, and 7 days using the visual analog scale (VAS). Sensitivity on percussion, spontaneous pain, swelling, and antibiotic and analgesic requirements of the patients were married during clinical examinations performed postoperatively after 2 and 7 days.
15726457|NCT05052788|Device|Optical coherence tomography angiography|"OCT-A detects the motion of blood using intrinsic signals to capture the location of blood vessels. Despite its insensitivity to leakage and the relatively small field of view, the development of OCT-A has the potential to improve our knowledge of the physiology and pathophysiology of the eye.
~MRI as a stroke protocol, including T1 and T2 weighted images, diffusion weighted images (DWI), fluid attenuated inversion recovery (FLAIR), magnetic resonance angiography (MRA), and gradient recalled echo (GRE) T2* weighted images, using a machine 1.5 tesla General Electric machine ."
15726458|NCT05052775|Other|Chlorhexidine Mouthwash|Patients were given chlorhexidine mouthwash 2 times per day for 15 days
15726459|NCT05052775|Other|Morus Alba 20%|Patients were given morus alba 20% concentration 2 times per day for 15 days
15726460|NCT05052775|Other|Morus Alba 30%|Patients were given morus alba 30% concentration 2 times per day for 15 days
15726461|NCT05052762|Other|Group A: Elastic resisted training for Gluteus Maximus strength|"Subjects attended physical therapy two times per week for a total of 10 visits. In the first five sessions, subjects performed the following exercises to strengthen the gluteus maximus: bilateral bridge, unilateral bridge, and non-weight-bearing hip extension in prone with the knee flexed at 90 degrees. In the next five sessions, abduction and external rotation in a quadruped (fire hydrant exercise) and weight-bearing hip extension (known as deadlift exercise) are added. Each exercise was performed for 10 repetitions. Elastic resistance was Added to the fire hydrant, hip extension in prone and deadlift exercises to allow each subject to perform at a 10-repetition maximum. The resistance for each subject was adjusted weekly as needed. The exercise program was performed under direct supervision only during the physical therapy sessions."
15726462|NCT05052762|Other|Group B: Weight resisted training for Gluteus Maximus strength|Subjects attended p two times per week for a total of 10 visits. The participants performed PHEKF in 90° knee flexion with 30° hip abduction and 10° hip extension to increase the muscle activity of the gluteus maximus. In the prone position, the participant performed 10° hip extension until the posterior knee reached the horizontal bar. The participants maintained 90° knee flexion with 30° hip abduction and 10° hip extension in the prone position against the resistance. Sandbags (3 kg) will be used to provide resistance on the ankle through a rope and pulley. Each subject performed three sets with three repetitions of five seconds each. 1-minute break is allowed between each set.
15726463|NCT05052749|Other|High Intensity Resistance Training (HIRT)|High Intensity Resistance Exercises Supervised High Intensity Resistance Training with 15 minutes of cycling as a warm-up activity then HIRT through Quadriceps drill, Squats, Lunges, Leg press, Biceps curls and Deadlift with 120 seconds of rest interval between each set of exercise and between exercises will be performed by the participants with appropriate cool down through generalized stretching exercises. Participants will perform exercises twice weekly, 40-50 minutes/session for 12 weeks respectively.
15726464|NCT05052749|Other|Low-moderate Resistance Exercise Training|Supervised Low-moderate Resistance Training with 15 minutes of cycling as a warm-up activity then Quadriceps drill, Squats, Lunges, Leg press, Biceps curls and Deadlift with 120 seconds of rest interval between each set of exercise and between exercises will be performed by the participants with appropriate cool down through generalized stretching exercises. Participants will perform exercises twice weekly, 40-50 minutes/session for 12 weeks respectively.
15728129|NCT05039190|Drug|Placebos|Placebo Injection
15726466|NCT05052723|Drug|Cabozantinib|Cabozantinib (XL184) is a potent inhibitor of multiple receptor tyrosine kinases (RTKs) known to play important roles in tumor cell proliferation and/or tumor neovascularization.
15726467|NCT05052723|Drug|Pembrolizumab|Pembrolizumab is a potent humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD-1) receptor, thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2).
15726470|NCT05052697|Biological|mIRV|Intramuscular injection
15726471|NCT05052697|Biological|bIRV|Intramuscular injection
15726472|NCT05052697|Biological|qIRV|Intramuscular injection
15726473|NCT05052697|Biological|QIV|Intramuscular injection
15726474|NCT05052684|Device|Leaflex™ Performer|A transfemoral catheter designed to treat calcific aortic stenosis by scoring the calcification in the aortic valve leaflets.
15726476|NCT05052645|Procedure|Auricular acupuncture|Placement of acupuncture needles in specific points on the ear in two consecutive treatments spaced 7 days apart.
15726477|NCT05052619|Drug|Preventive use of advanced antibiotics|Treat patients in this group with advanced preventive usage of antibiocs: Sulperazon 3g q8h, in postoperative days 1-5.
15726478|NCT05052619|Other|Routine|Treat patients in this group with routine preventive usage of antibiocs: Cefmetazole 1g q12h, in postoperative days 1-3.
15726479|NCT05052606|Other|No intervention|This study is an observational study without treatment intervention.
15726480|NCT05052593|Other|compressive myofascial release|Patients in this group will receive treatment through CMR that includes shaking the muscle belly of vastus lateralis for 30 seconds. Then the hip is fully extended on treatment table and CMR is applied on Vastus lateralis muscle for 1 minute. Treatment consists of broad strokes applied with clinicians knuckles to release superficial restrictions, followed by more specific strokes applied with clinicians' thumb on tight muscle. Strokes are applied at a contact point of 45 degree. With pressure directed from distal to proximal.
15726481|NCT05052593|Other|conventional treatment group|Patients in this group will receive treatment of Hot pack and Tens for 20 minutes, Range of motion exercises (knee flexion and extension ROM's), Stretching exercises (3sets, 10 reps for 5 second hold)
15726482|NCT05052580|Other|COVID-19 Testing|Participants who consent to participate in this study will be tested at days 1, 3, 5, and 7 following a known COVID-19 exposure on day 0. If the COVID-19 tests are negative, the participant will remain in the school environment. A positive COVID-19 test or the development of symptoms on any day after exposure would require isolation according to school, local and state guidelines.
15726483|NCT05052567|Drug|CEND-1|The dose is specified according to the protocol. CEND-1+paclitaxel (albumin-bound type)+gemcitabine
15726484|NCT05052554|Drug|QR-504a|Intravitreal (IVT) injection
15726485|NCT05052541|Drug|THC/CBD|Oral solution containing 5mg THC and 50 mg CBD per 1 ml
15726486|NCT05052541|Drug|THC|Oral solution containing 5mg THC per 1 ml
15726487|NCT05052541|Drug|Placebo|Oral solution containing no active drug
15726488|NCT05052528|Biological|Chimeric Antigen Receptor T-Cell Therapy|Given CD19 CAR T cells IV
15726489|NCT05052528|Drug|Cyclophosphamide|Given IV
15726490|NCT05052528|Drug|Fludarabine Phosphate|Given IV
15726491|NCT05052528|Biological|Rituximab|Given IV
15726492|NCT05052515|Dietary Supplement|Choline - Vitamin C, E and Ampelopsis Grossedentata natural extracts|Patients with NAFLD will be randomly allocated to receive Choline - Vitamin C, E and Ampelopsis Grossedentata natural extracts supplementation
15726493|NCT05052515|Other|Placebo|Patients with NAFLD will be randomly allocated to receive placebo
15726494|NCT05052502|Other|Case Management and Follow-up|"Individuals will be told of their test result and a positive test result on either RDT will prompt treatment as per the national treatment guidelines.
~Individuals with P. falciparum infection will be treated with an age-appropriate course of dihydroartemisinin/piperaquine (DHAP) or artesunate-pyronaridine (Pyramax) and PQ.
~At all study sites in Thailand, patients with a P. vivax infection identified by the standard combination RDT will be tested by the VMV and Health Promotion Hospital (HPH) staff member using the quantitative G6PD RDT. G6PD normal individuals will be treated with Chloroquine (CQ) and a 14-day course of primaquine (PQ). G6PD deficient individuals will receive CQ alone and referred to the nearest health facility for further primaquine management decisions."
15726495|NCT05052502|Other|Reactive focal mass drug administration (rfMDA)|"Reactive focal mass administration (rfMDA) will be implemented around the index case household and to forest co-workers/co-travelers in Thailand. The VMV will conduct the investigation visit within 7 days after the notification of the index case. All members of the index case's household as well as all members of the nearest five households around the index case's household, including temporary visitors will be invited to participate in the study and to be treated for malaria without a malaria test. After obtaining participants' or parents/guardians' consent, the VMV will proceed with the participant questionnaire, and all consenting household members will be tested for G6PD using the G6PD quantitative test prior to administration of antimalarials.
~For rfMDA, all eligible participants will be offered artesunate-mefloquine (AS-MQ). Per national policy, a 14-day course of primaquine will be administered to G6PD non-deficient study participants."
15726496|NCT05052489|Other|registy|Children with diarrhea were registered in the hospital. Baseline information of the children was recorded and followed up to observe the distribution of disease types, clinical manifestations, treatment plans and clinical outcomes
15726497|NCT05052476|Dietary Supplement|Bactecal® D Liquid|The patients will be randomized into two arms, A and B, in function of the intervention dose
15726498|NCT05052463|Other|electrolyte imbalance analysis|ın this retrospective study we aimed to evaluate the relationship between the ıcu prognosis and the electrolyte imbalance
15726499|NCT05052450|Other|Observational|Patients data were collected throughout the following time
15726529|NCT05052177|Device|Edge to edge repair in systemic tricuspid valve regurgitation|Edge to edge repair of severe tricuspid regurgitation on a right systemic ventricle with a Mitraclip device.
15728130|NCT05039177|Drug|ERAS-007|Administered orally
15726500|NCT05052437|Drug|Utidelone Injection; capecitabine|8 patients will be assigned to utidelone plus capecitabine arm receiving utidelone plus capecitabine. Utidelone injection 30mg/m2/day, intravenously administered once a day for 5 consecutive days; capecitabine tablets, 1000mg/m2, orally, 2 times a day for 14 consecutive days. 21 days is a cycle
15726501|NCT05052437|Drug|Utidelone|8 patients will be assigned to utidelone arm and receive utidelone injection 30 mg/m2/day intravenously, once a day for 5 consecutive days in a 21-day cycle.
15726502|NCT05052424|Diagnostic Test|Analysis of cytokines and immun cell related markers|blood samples
15726503|NCT05052411|Other|App usage assessments and analytics|All participants will be given a brief overview of the purpose of the study followed by a survey on participant characteristics and barriers to accessing HIV testing and PrEP uptake and P/SUD support services. The participant will be observed downloading the JomPrEP app and instructed with a brief tutorial on the onboarding process. The participant will be told to keep the app for 3 months and encouraged to use all app components. At 30 and 60 days, the participants will be delivered brief periodic assessments and will provide a synthesis of issues that have emerged. At 90 days, the participant will complete a post-survey, to which the Systems Usability Scale will be added. App analytics will also be collected (e.g., the number of logins). Participants will be asked to provide feedback on functionality, performance, and errors encountered, motivation to use the app, overall experiences using the app, feedback for further refinement, and subjective impact of the app on HIV prevention.
15726504|NCT05052398|Drug|PSP NEURO SERUM|PSP NEURO SERUM is a topical product that contains a concentration of Paralytic Shellfish Toxins of 10 micrograms/mL of equivalent of Gonyautoxin 2/3. Each patient will apply 1 g of PSP NEURO SERUM in their hands.
15726505|NCT05052385|Drug|Ruxolitinib|As per treating physician's decision - non interventional study
15726506|NCT05052385|Device|Extracorporeal photopheresis|As per treating physician's decision - non interventional study
15726507|NCT05052385|Drug|Ibrutinib|As per treating physician's decision - non interventional study
15726508|NCT05052372|Drug|Balversa|BALVERSA® is a prescription medicine used to treat adults with bladder cancer (urothelial cancer) that has spread or cannot be removed by surgery
15726509|NCT05052359|Diagnostic Test|Lectin-histochemistry retrospectively performed|Lectin-histochemistry was performed on 37 archival paraffin wax-embedded specimens of various follicular thyroid tumours (10 follicular adenomas (FA), 10 minimally invasive follicular carcinomas (miFTC), 13 widely invasive follicular cancers (wiFTC) and 4 metastatic follicular thyroid cancers (metFTC)).
15726510|NCT05052320|Device|Audiological assessment|TO assess audiological profile in recovered covid19 subjects
15726511|NCT05052307|Drug|Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine|Pfizer/BioNTech BNT162b2 mRNA COVID-19 vaccine
15726512|NCT05052307|Drug|CoronaVac COVID-19 vaccine|CoronaVac COVID-19 vaccine
15726513|NCT05052307|Drug|ChAdOx1 nCoV-19 Covid-19 Vaccine|ChAdOx1 nCoV-19 Covid-19 Vaccine
15726514|NCT05052281|Behavioral|Mothers and Babies (MB) Course|The Mothers and Babies course (MB) is a 12-session manualized stress-reduction intervention that will be delivered to participants, prenatally, with an integrated technology suite designed for timely detection and response to maternal stress.
15726515|NCT05052281|Behavioral|Just in Time Intervention (JITI) Content|"Participants will also receive additional MB intervention content in the form of just-in-time text messages, which will be sent to participants' smartphones every other day for up to 12 weeks. During the current trial, participants will receive text message prompts with links to additional stress reduction content based on a combination of their objective (sensor) and subjective (EMA) stress responses from the previous day."
15726516|NCT05052281|Device|Biostamp nPoint Device|During the intervention period, participants will be asked to wear the BioStamp nPoint sensor, daily, while engaging in their usual activities (e.g., sleep, showering, exercise). The BioStamp Sensor is a thin, wearable patch, equipped with wireless high-range 6-axis gyroscope + accelerometer, and sEMG and ECG sensors, that adheres to the skin using a disposable medical-grade adhesive sticker (with adhesive similar to Band-Aid).
15726517|NCT05052268|Drug|XTX202|XTX202 Monotherapy
15726518|NCT05052255|Drug|RVU120|RVU120 will be administered as a single oral dose every other day for a total of 7 doses over a 3 week treatment cycle until disease progression or unacceptable toxicity.
15726519|NCT05052242|Diagnostic Test|primary angle closure disease|2 swept source OCT biometers, IOL Master700 and Anterion
15726520|NCT05052229|Drug|Nitric Oxide|Nitric oxide gas for inhalation
15726521|NCT05052229|Drug|Medical air|Medical grade air for inhalation (placebo)
15726522|NCT05052203|Other|Exposure of interest: study DNA methylation (epigenetics) and gene expression (transcriptomics) of blood leukocytes|The primary objective is to study DNA methylation (epigenetics) and gene expression (transcriptomics) of blood leukocytes between sepsis survivors at ED admission and three months after hospital discharge
15726523|NCT05052190|Behavioral|Text Message R/R with Direct Appointment Schedule Link|Participants in this arm will receive up to 3 R/R messages by text reminding them to get a flu vaccine with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment.
15726524|NCT05052190|Behavioral|Text Message R/R without Direct Appointment Schedule Link|Participants in this arm will receive up to 3 R/R messages by text reminding them to get a flu vaccine without a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment.
15726525|NCT05052190|Behavioral|Text Pre-Appointment Reminder|Participants will receive a Pre-Appointment Reminder via text when they schedule a visit during the study period advising them to get the flu vaccine at their upcoming appointment.
15726526|NCT05052190|Behavioral|Portal Message R/R with Direct Appointment Schedule Link|Participants in this arm will receive up to 3 R/R messages by portal. R/R message will be sent with a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment.
15726527|NCT05052190|Behavioral|Portal Message R/R without Direct Appointment Schedule Link|Participants in this arm will receive up to 3 R/R messages by portal. R/R message will be sent without a Direct Appointment Scheduling link and instructions to make a flu vaccine appointment.
15726528|NCT05052190|Behavioral|Portal Pre-Appointment Reminder|Participants will receive a Pre-Appointment Reminder via the portal advising them to ask their doctor for the flu vaccine at their upcoming appointment via text when they schedule a visit during the study period.
15726627|NCT05051345|Other|Media Intervention|Download and use the Wellness app
15726530|NCT05052164|Behavioral|Gluten-free nutrition plan + exercise group|Menopausal or post-menopausal celiac women will follow a physical exercise program 3/4 times per week and their dietary intake will be gluten-free isocaloric
15726531|NCT05052164|Behavioral|Gluten-free nutrition plan group|Menopausal or post-menopausal celiac women will follow a gluten-free isocaloric dietary program
15726532|NCT05052164|Behavioral|Active Comparator: Celiac controls group|Menopausal or post-menopausal celiac women in whom all the tests were measured but they did not perform an intervention program with physical exercise or special follow-up of an adapted dietary-nutritional program
15726533|NCT05052151|Other|Low dialysate temperature|35°C
15726534|NCT05052151|Other|High dialysate temperature|37°C
15726535|NCT05052151|Other|Low dialysate bicarbonate concentration|30 mmol/L
15726536|NCT05052151|Other|High dialysate bicarbonate concentration|38 mmol/L
15726537|NCT05052138|Other|Tactile massage1|Tactile massage1 will receive one 15-min tactile massages(hand massage) per week for 6 weeks
15726538|NCT05052138|Other|Tactile massage2|Tactile massage2 will receive five 15-min tactile massages (hand massage)per week for 6 weeks
15726539|NCT05052125|Drug|Oxygen|Administering oxygen to achieve the desired peripheral oxygen saturation
15726540|NCT05052112|Other|E-PR-01|Active arm
15726541|NCT05052112|Other|E- PR-02|Placebo arm
15726542|NCT05052099|Drug|mFOLFOX6, Atezolizumab and Bevacizumab|"All study medication is administered by intravenous (IV) infusion on Day 1 of each 14-day cycle:
~• mFOLFOX6 consisting of Folinic acid (Leucovorin) 400 mg/m2 (D,L racemic form) or 200 mg/m2 (L-isomer form [levo leucovorin]), 5-fluorouracil (5-FU) 2400 mg/m2 and Oxaliplatin 85 mg/m2
~combined with
~Atezolizumab 840 mg and
~Bevacizumab 10 mg/kg"
15726543|NCT05052086|Diagnostic Test|Magnetomotoric ultrasound|Nanoparticles will be injected close to the tumor. Magnetomotoric ultrasound will be performed just before scheduled standard operation, when the patient is anesthetized.
15726544|NCT05052073|Diagnostic Test|oral glucose load at rest|oral glucose load (75 g) after an 12h overnight fast at rest accompanied by blood sampling and dialysate sampling (adipose tissue and skeletal muscle), and calorimetry (canopy) over three hours.
15726545|NCT05052073|Diagnostic Test|oral glucose load and exercise|oral glucose load (75 g) after an 12h overnight fast followed by a defined (0.5 W / kg), moderate bicycle exercise i a metabolic chamber
15726548|NCT05052047|Other|Brisk Walking Group|Brisk Walk: 20 min/day (The researchers found, for most people, brisk walking could be defined as moving at a pace of 2.7 miles per hour or 100 steps per minute for adults under about age 60 or guidelines define brisk walking as occurring when individuals move at a pace that increases their heart rate to about 70% of their heart rate maximum) Patient will also perform breathing exercises as given to Control group, Positioning (lean forward when needed) Percussion coughing when needed
15726549|NCT05052047|Other|Conventional Breathing Exercise Group|"Breathing exercises: 20 min/day
~Breathing Ex includes:
~• Pursed lip breathing: Sit with your back straight, inhale through your nose for 2 seconds. Purse your lips like you rae blowing on hot food and then breath out slowly, take twice as long to exhale as you took to breath in 4-5 times a day
~• Diaphragmatic breathing: Lie on your back on a flat surface, knees bent and head supported. Use pillow under knees to support your legs . breathe in slowly through your nose tighten your stomach, letting them fall inward as you exhale through your pursed lips. Practice these exercises 5-10 minutes about 3-4 times a day.
~Positioning (lean forward when needed) Percussion coughing when needed"
15726550|NCT05052034|Other|Music|Through headphones, the patients would listen to different types of music during the intervention.
15726551|NCT05052021|Other|Recent or Peri-Operative Covid19 Infection|No intervention will be done. The groups will be differentiated based on whether they had recent or peri-operative Covid19 infection (group 1), or whether they have had no or previous Covid19 infection (Group 2)
15726552|NCT05052008|Drug|Erenumab|Erenumab is monoclonal antibody used for management of migraine
15726555|NCT05051982|Other|Sedline EEG in View|EEG monitor (Sedline) will be in full view of the Anesthesiologist during surgery.
15726556|NCT05051969|Behavioral|Remote Mindfulness-Based Stress Reduction Program|Enrolled participants will participate in a remote-delivered (online with audio and video) Mindfulness-Based Stress Reduction (MBSR) program. MBSR is a well established behavioral health intervention consisting of 10-sessions lasting 2.5 hours, with one session lasting 7.5 hours in an all-day retreat format over a 2-month period.
15726557|NCT05051956|Drug|Palbociclib 125mg and Ribociclib 600 mg|Administration of Palbociclib or Ribociclib
15726560|NCT05051891|Drug|Orelabrutinib and R-CHOP|Orelabrutinib in Combinaion with Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)
15726561|NCT05051891|Drug|R-CHOP|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP)
15726562|NCT05051878|Device|T-scan|occlusal analysis T-scan
15726563|NCT05051878|Other|articulating paper|articulating paper occlusal analysis
15726564|NCT05051865|Drug|camrelizumab|camrelizumab combined with SHR1020 for advanced melanoma
15726565|NCT05051865|Drug|SHR1020|camrelizumab combined with SHR1020 for advanced melanoma
15726566|NCT05051852|Other|Follow up|Participants will be followed up at 6, 12 and 24 months with HPV viral load tests, Thinprep cytologic tests (TCT) and vaginal secretion tests.
15726567|NCT05051839|Procedure|Implant surgery and restoration|Implants with two different transmucosal neck configuration are placed.
15726628|NCT05051345|Other|Questionnaire Administration|Ancillary studies
15726629|NCT05051345|Behavioral|Smoking Cessation Intervention|Receive Smoke-Free Homes kit
15726568|NCT05051826|Other|Resistance training that combines water and land|"Device: Swimmers in the experimental group received resistance training in water for 12 weeks, and the resistance training in the experimental group was divided into 3 categories:Resistance palm and resistance umbrella, resistance suit.
~Device: The swimmers in the experimental group underwent core strength training on land for 12 weeks, and the resistance training in the experimental group was divided into 4 types of resistance zones: Swiss ball, medicine ball and drive zone.The combination of two resistance training methods can improve teenagers' swimming performance."
15726569|NCT05051800|Behavioral|Online Program to Support Coping and Communication in Families|Parents and children will access online materials designed to support the use of effective ways to cope with the diagnosis and treatment of cancer and to support open and communication.
15726570|NCT05051787|Biological|Blood and milk samples|"2 types of samples will be taken over the same time slots in breastfeeding mothers treated with amoxicillin for at least 2 days:
~3 breast milk collections of about 20 ml each made using an electric breast pump provided to the participant.
~3 blood samples of approximately 5 ml each."
15726571|NCT05051774|Behavioral|1. Education|Three monthly face-to-face group education with 8 to10 participants using a validated educational booklet will be provided by the researcher at the study hospital.
15726572|NCT05051774|Behavioral|2. Exercise|"The exercise intervention comprised of two elements as follows:
~Three monthly hospital-based supervised group exercise consists of 8 to 10 participants. First two sessions: warm-up exercise-5 minutes, brisk walking-20 minutes at low intensity with music, and cool-down exercise-5 minutes. Third session: brisk walking for 30 minutes at moderate intensity with music.
~Twelve-weeks home-based exercise: The participants will be asked to continue the exercise performed in the previous week at the hospital with music at least five times per week."
15726573|NCT05051774|Behavioral|3. Telephone follow-up|A 20-minutes telephone follow-up at weeks 3, 7, and 11 for strengthening the volition of the participant to perform the exercise and follow the healthy diet at home.
15726574|NCT05051761|Drug|Jaktinib|Administered orally.
15726575|NCT05051761|Drug|placebo|Administered orally.
15726576|NCT05051748|Other|Opalescence™ boost™ PF 40%|40% hydrogen peroxide in-office bleaching
15726577|NCT05051748|Other|Opalustre™|6.6% hydrochloric acid and silicon carbide microparticles microabrasion paste
15726578|NCT05051748|Other|MI-Paste Plus®|casein phosphopeptide amorphous calcium fluoride phosphate (CPP-ACFP) remineralizing tooth crème
15726581|NCT05051722|Diagnostic Test|Tampon Collection|A tampon will be self-inserted by each participant prior to any exams or procedures and removed after 40 minutes..
15726582|NCT05051722|Diagnostic Test|Blood Collection|A blood sample will be collected from each participant prior to undergoing any exams or procedures.
15726583|NCT05051709|Procedure|Corrective osteotomy|First metatarsal distal corrective osteotomy
15726584|NCT05051709|Procedure|Fusion of First ray|Fusion of first ray with soft tissue procedure
15726585|NCT05051696|Drug|H101|Intra-tumor injected oncolytic viruses H101 within 5 consecutive days,3 weeks for a cycle (1-4cycles)
15726586|NCT05051683|Procedure|combined endoscopic & radiologic intervention for management of acute perforated peptic ulcer|endoscopic management using stent , clipping and sewing combined with radiologic interventional drainage was used. For duodenal ulcer only metallic stent was used due to narrow space while for gastric ulcer either stent , clipping and sewing were used due to capacious space.
15726587|NCT05051670|Procedure|da vinc SP gastrectomy|radical subtotal gastrectomy performed by da vinci SP
15726588|NCT05051657|Dietary Supplement|PKU express plus|PKU express plus is a powdered protein substitute for the dietary management of PKU. It is formulated in a variety of flavours to provide a convenient, low volume, lower calorie, pre-measured protein substitute, containing a full micronutrient profile.
15726591|NCT05051631|Other|Intervention plus 12 months maintenance|The intervention will include 2 months of data collection in the control period, 4 months of education and awareness training, and 12 months of data collection in the maintenance time period.
15726592|NCT05051631|Other|Intervention plus 10 months maintenance|The intervention will include 4 months of data collection in the control period, 4 months of education and awareness training, and 10 months of data collection in the maintenance time period.
15726593|NCT05051631|Other|Intervention plus 8 months maintenance|The intervention will include 6 months of data collection in the control period, 4 months of education and awareness training, and 8 months of data collection in the maintenance time period.
15726594|NCT05051631|Other|Intervention plus 6 months maintenance|The intervention will include 8 months of data collection in the control period, 4 months of education and awareness training, and 6 months of data collection in the maintenance time period.
15726630|NCT05051345|Other|Survey Administration|Ancillary studies
15726595|NCT05051631|Other|Intervention plus 4 months maintenance|The intervention will include 10 months of data collection in the control period, 4 months of education and awareness training, and 4 months of data collection in the maintenance time period.
15726596|NCT05051618|Behavioral|POWER-MS|"The POWER-MS intervention includes both aerobic exercise and resistance exercise:
~Aerobic Exercise:
~The goal of the aerobic exercise training is for participants to achieve three moderate-intensity walking sessions of 30+ minutes per session by the end of the 16-week intervention.
~Resistance Exercise:
~Participants will complete resistance exercise training that consists of 1-2 sets (10-15 repetitions) of 5-10 exercises targeting the lower body, upper body, and core muscle groups performed three days per week, with the sets, repetitions and number of exercises increasing based on an individualized difficulty level."
15726597|NCT05051618|Behavioral|FLEX-MS|The FLEX-MS intervention is specifically a stretching exercise prescription. All exercise movements are consistent throughout the program. At the beginning of the program, the stretching exercise sessions will take five minutes (1 set) three days per week (15 minutes per week). By the end of the 16-week program, the sessions will take about 30 minutes (2 sets) to be performed three days per week (1.5 hours per week).
15726598|NCT05051605|Biological|COVID-19 Vaccine|Severe acute respiratory syndrome- coronavirus-2 (SARS-CoV-2)vaccine according to vaccine availability in the Egyptian ministry of health.
15726603|NCT05051553|Drug|Fedratinib|Specified dose on specified days
15726604|NCT05051540|Device|Sigvaris Compreflex Inelastic Compression Wrap|Compreflex compression system using wraps to apply compression of 30-40 mmHg.
15726606|NCT05051514|Diagnostic Test|Evaluation|To examine the differences in respiratory functions, orofacial muscle tone changes, anxiety/depression, and quality of life of the patients according to the severity of Obstructive Sleep Apnea Syndrome.
15726607|NCT05051501|Dietary Supplement|Probiotics C2P|Probiotics will supplement normal diet. Unlike other products available on the market, which are usually of bovine origin, our probiotic has been manufactured using human-stemmed lines. The supplements are composed of a mixture of naturally occurring human gut bacteria.
15726608|NCT05051488|Procedure|Dynamic craniotomy|Dynamic decompressive craniotomy with semi-rigid bone flap fixation
15726609|NCT05051488|Device|Dynamic craniotomy|Dynamic decompressive craniotomy with semi-rigid bone flap fixation
15726610|NCT05051475|Procedure|Endoscopic radiofrequency ablation|Endoscopic ablation technique for Barrett's epithelium
15726611|NCT05051475|Procedure|Endoscopic hybrid argon plasma coagulation|Endoscopic ablation technique for Barrett's epithelium
15726612|NCT05051462|Behavioral|Family / systemic constellation therapy|Family / systemic constellation therapy is a short-term group counseling intervention aiming to help clients better understand and resolve their conflicts within their personal systems, which in turn might lead to a decrease in psychopathological or functional somatic symptoms. The personal system addressed is most often the family but other inter- or intrapersonal systems (e.g., ego parts, victim-perpetrator dyads) can also be the target of the intervention.
15726613|NCT05051449|Drug|Ketamine Hydrochloride|Ketamine will be administered by a nurse in a 2-week treatment phase, during which participants will receive six IV infusions of 0.5 mg/kg (over 40-50 minutes) ketamine three times per week. Infusion days for patients will be on Mondays, Wednesdays, and Fridays, +/- 1 day. Ketamine infusions will take place at the UMB General Clinical Research Center (GCRC). The GCRC nurse will deliver ketamine within a private exam room. The infusions will last 40-50 min, and the participant will be observed by the GCRC clinical staff for 2 hours post-infusion. Vital signs will be monitored throughout the treatment; specifically, blood pressure, pulse ox and heart rate will be checked prior to treatment, q20 minutes during infusion, and q30-60 minutes after infusion for up to three hours.
15726614|NCT05051436|Drug|Mirabegron 50 MG|Mirabegron 50 mg/day will be administered for 14 weeks.
15726615|NCT05051436|Drug|Tadalafil 10 MG|Tadalafil 10 mg/day will be administered for 14 weeks after baseline procedures.
15726616|NCT05051436|Drug|Placebo|Placebo will be administered for 14 weeks after baseline procedures.
15726617|NCT05051423|Diagnostic Test|Endoscopic ultrasound|"Imaging tests:
~All patients will be evaluated by EUS and CEH-EUS, using radial EUS instruments. Prior to the investigation the stomach has to be empty for at least 8 hours. During the examination biopsies will be taken from normal and tumor tissue for gene expression analysis.
~CEH-EUS procedure:
~A two panel image with the usual conventional gray-scale B-mode EUS image on the right side and with the contrast harmonic image on the left side will be used, according to pre-established presets. The starting point of the timer will be considered the moment of intravenous contrast injection (Sonovue 2,4 mL), with the whole movie (T0-T120s) recorded on the embedded HDD of the ultrasound system for later analysis
~Molecular tests:
~Blood analysis. Whole blood (1ml) will be collected before imaging procedures in an Eppendorf tube on EDTA solution.
~Biopsy samples of normal and GC tissue. Gene expression will be analyzed using qPCR with Taqman®- labeled probes."
15726618|NCT05051410|Procedure|intracanal cryotherapy using needle irrigation and EndoVac system|a cold saline will be used as final irrigant in two groups but with different irrigation systems.
15726619|NCT05051397|Biological|HYPERCAPNIA|Controlled moderate hypercapnia PaCO2 50mmHg under general anesthesia with mechanical ventilation
15726620|NCT05051397|Biological|NORMOCAPNIA|Controlled normocapnia PaCO2 40mmHg under general anesthesia with mechanical ventilation
15726621|NCT05051384|Diagnostic Test|Doppler technology|The study of tumor vascularization can help in the differential diagnosis and follow-up of tumors, and therefore can impact the management of patients with tumors
15726622|NCT05051371|Device|Train of four monitoring|Train of four monitoring in postoperative care unit
15726623|NCT05051358|Procedure|Therapeutic Endoscopic Ultrasound|Therapeutic Endoscopic Ultrasound or Interventional Endoscopy for Gastrointestinal Indications
15726624|NCT05051345|Other|Informational Intervention|Receive information on the services provided for pregnant women and smoking cessation
15726625|NCT05051345|Other|Informational Intervention|Receive tobacco cessation self-help materials
15726626|NCT05051345|Other|Informational Intervention|Receive Smoke-Free Homes mailings
15726632|NCT05051345|Behavioral|Telephone-Based Intervention|Receive a coaching call from a Baby Steps for Health counselor
15726633|NCT05051345|Other|Tobacco Cessation Counseling|Receive telephone counseling sessions
15726634|NCT05051332|Drug|Autologous Chondrocyte Implantation (CartiLife®)|CartiLife consists of small beads (1 mm in diameter) in suspension, developed from pellet culture of autologous costal chondrocytes after multiplication. The beads are implanted in an injective manner with fibrin glue through minimal arthrotomy. The dose depends on the size (volume) of the defect, recommended dose is 480 pellets/cm^3 defect
15726635|NCT05051332|Procedure|Microfracture Surgery|Microfracture surgery, performed by arthroscopy after the joint is cleaned of calcified cartilage, will be conducted using an awl or drill to create tiny fractures in the subchondral bone plate
15726636|NCT05051306|Other|High-load resistance exercise|Subjects in high-load trial performed 4 sets per exercise, 8 repetitions with load of 85%-8RM with 90 sec of rest between sets.
15726637|NCT05051306|Other|Low-load resistance exercise|Subjects in low-load trial performed 4 sets per exercise, 15 repetitions with load of 45%-8RM with 90 sec of rest between sets.
15726638|NCT05051293|Other|serum concentration of estrogen (E1 and E2) and testosterone ratio measurement|To measure the serum concentration of estrogen (E1 and E2) and testosterone ratio in all male cirrhosis patients
15726639|NCT05051280|Procedure|cone-beam computed tomography fusion image|Left Atrial Appendage Occlusion Under Cone-beam Computed Tomography Fusion Image Guidance
15726640|NCT05051267|Other|Non-Pharmacological Methods|All of the applications that increase the effectiveness of drugs when used together with analgesics and provide the elimination of pain by releasing our body's natural morphine and endorphins without the use of analgesics are called non-pharmacological treatment.
15726641|NCT05051254|Other|Esogastric pressure measurement|"Measurement of work of breathing and respiratory muscles strength using an esogastric catheter.
~One measurement or before and after (6 months and 1 year) the initiation of a pharmacological treatment in order to assess the effect of the treatment on respiratory muscle function."
15726642|NCT05051241|Drug|GFH018|Subjects will receive GFH018 orally at different dose levels following twice daily, 14-day on/14-day off regimen.
15726643|NCT05051228|Device|CardioFlux|Magnetocardiography (MCG) is a noninvasive method that measure the magnetic field that arises from the electrical activity of the heart cycle.
15726644|NCT05051202|Other|Sugars from Fiber|Proprietary blend of Sugars from Fiber baked into 50 g flapjack
15726645|NCT05051202|Other|Resistant Maltodextrin|Resistant Maltodextrin baked into 50 g flapjack
15726646|NCT05051189|Drug|Fentanyl Citrate|Ventilatory response to fentanyl in patients with OSA Specifically: respiratory changes, CO2, RR, TV
15726647|NCT05051176|Diagnostic Test|2D usg and 3D usg|IRD distance measured by a linear probe 2D usg. Occurrence of - cystocele, rectocele, and prolapse of the uterus by ultrasound and standard gynaecological examination.
15726648|NCT05051163|Drug|Ceftriaxone Sodium|7 days of once daily dosing
15726649|NCT05051163|Drug|Ampicillin|7 days of 6 hourly dosing
15726650|NCT05051163|Drug|Gentamicin|7 days of once daily dosing
15726651|NCT05051150|Drug|Epinephrin 0.03|epinephrine infusion rate of 0.03 mcg/kg/min will start from subarachnoid injection of local anesthetic until 5-min after baby delivery
15726652|NCT05051150|Drug|Epinephrin 0.05|epinephrine infusion rate of 0.05 mcg/kg/min will start from subarachnoid injection of local anesthetic until 5-min after baby delivery
15726653|NCT05051150|Drug|Epinephrin 0.07|epinephrine infusion rate of 0.07 mcg/kg/min will start from subarachnoid injection of local anesthetic until 5-min after baby delivery
15726654|NCT05051137|Biological|Infliximab|Initiation of infliximab in any dose and frequency of administration. Could be discontinued for safety reasons and replaced by etanercept.
15726655|NCT05051137|Drug|Sulfasalazine + Hydroxychloroquine|Initiation of sulfasalazine and hydroxychloroquine not more than 180 days apart, in any dose and frequency of administration. Any one of the two drugs could be discontinued. while continuing the other, or both could be replaced by cyclosporine, for safety reasons.
15726656|NCT05051124|Behavioral|Peer Delivery of Medications|The study team will adopt a novel approach of extending beyond the use of peer support in the clinical setting and implement door-to-door peer delivery of medications within patients' communities
15726657|NCT05051124|Behavioral|Health Information Technology (HIT) Platform|To support peer delivery, the study team will use a HIT platform that performs 4 core functions: 1) tailored counseling strategies through decision support; 2) teleconsultation support for clinician-peer-patient interactions; 3) tracking medication refills to enhance accountability of the peer delivery process; and 4) analytics to improve medication supply chain by generating patient-level drug consumption data. This is an innovative use of HIT to accomplish these functions to support medication adherence.
15726658|NCT05051098|Other|No intervention|No intervention
15726659|NCT05051085|Behavioral|"Internet-delivered treatment: SpilleFri."|The guided internet program consists of 8 modules over a period of 10 weeks. The content is written psychoeducation, videos with patients and experts, and exercises (encouraging reflection, cognitive restructuring, and exposure). The program is therapist-guided; hence all patients will receive support primarily from a specific therapist during the 10 weeks.
15726660|NCT05051072|Procedure|"Assessment of the trigeminal nerve by diffusion tensor MRI and in resting state in the context of essential neuralgia"|"Assessment of the trigeminal nerve by diffusion tensor MRI and in resting state in the context of essential neuralgia"
15726663|NCT05051046|Procedure|Colonoscopy under hypnosis|The hypnosis used will be of the Ericksonian type. Before the colonoscopy begins, the IDE puts the patient in a hypnotic situation.
15726664|NCT05051033|Procedure|Mitral valve repair|Patients who are randomized to the surgical arm will undergo mitral surgery. Mitral surgery will be conducted using general anesthesia and cardiopulmonary bypass. Mitral surgery may be performed via a sternotomy or a right thoracotomy approach with or without robotic assistance. Standard techniques commonly include a ring or band annuloplasty to correct and prevent annular dilatation; leaflet prolapse and redundancy may be corrected by leaflet resection techniques and / or chordal reconstruction.
15728131|NCT05039177|Drug|Encorafenib|Administered orally
15726665|NCT05051033|Device|Transcatheter edge-to-edge repair|Patients will be treated with a commercially-approved edge-to-edge mitral repair device. Before using the investigational device, each patient will undergo baseline hemodynamic assessment. The steerable guide catheter (guide) is inserted into the femoral vein and advanced across the inter-atrial septum using image guided puncture. Fluoroscopic and echocardiographic guidance will be used to visualize the devices and assess the repair. The guide is positioned over the MV and the clip delivery system is inserted into the guide and positioned over the MV in accordance with the manufacturer's instructions. The delivery catheter is advanced until the clip emerges from the tip of the guide into the left atrium. The catheter is manipulated using the control handle until the clip is correctly oriented with respect to the line of coaptation of the mitral valve. The clip is opened, and advanced across the mitral valve into the left ventricle then pulled back to grasp the leaflets.
15726666|NCT05051020|Device|Near Infrared Vein Imaging|Use of NI vein imaging device for visualization of veins during peripheral IV placement
15726667|NCT05051020|Other|Conventional IV placement|IV placement utilizing conventional methods
15726668|NCT05051007|Drug|fentanyl|patients will receive 1 mcg/kg of fentanyl (the drug will be diluted to 10 mcg/mL)
15726669|NCT05051007|Drug|Lidocaine IV|patients will receive 1 mg/kg lidocaine (the drug will be diluted to10mg/mL)
15726670|NCT05050994|Procedure|Microwave ablation|Children with symptomatic secondary splenomegaly will receive partial microwave ablation of spleen (up to 40-50% of total volume)
15726671|NCT05050981|Drug|Hormone replacement therapy|Hormone replacement therapy: menopause hormone therapy with estrogen-only or oestrogen-progestin.
15726672|NCT05050981|Drug|Selective serotonin reuptake inhibitors|Selective serotonin reuptake inhibitors: anyone in the category, e.g.: fluoxetine, sertraline, etc.
15726673|NCT05050968|Other|Physical activity|Between V1 and V2 (i.e. 12 weeks), the APAG (Adapted Physical Activity Group) will participate at a physical training program, 3 sessions of 1h30 per week consisting of endurance activities (60-75% of VO2 peak) and muscle strengthening while the CG will not perform any controlled physical training program. Then, between V2 and V3, no APA (Adapted Physical Activity) program will be offered to both groups.
15726677|NCT05050929|Radiation|Targeting All Brain Metastases|Volumetric Modulated Arc Therapy
15726680|NCT05050903|Other|Rhinovirus infection|Inoculation with rhinovirus-16
15726681|NCT05050890|Other|ctDNA level during neoadjuvant chemotherapy|ctDNA samples will be collected from patients at baseline, during neoadjuvant therapy (every 15 days) and before the surgical procedure
15726682|NCT05050864|Procedure|venous sinus stenting /neurosurgical internal ventricular shunt on papillary edema|venous sinus stenting versus neurosurgical internal ventricular shunt on papillary edema in the management of idiopathic intracranial hypertension
15726683|NCT05050851|Dietary Supplement|Measurement of nutritional parameters in children with pneumonia|measurement of Body Mass Index, head circumference, weight, length
15726684|NCT05050838|Other|Transcranial Doppler (TCD)|"TCD ultrasonography is based on the principle of the Doppler effect. According to this principle, ultrasound waves emitted from the Doppler probe are transmitted through the skull and reflected by moving red blood cells within the intracerebral vessels. The difference in the frequency between the emitted and reflected waves, referred to as the Doppler shift frequency, is directly proportional to the speed of the moving red blood cells (blood flow).
~Cerebral blood flow (in cm/s) of the middle cerebral artery will be measured with TCD in blood-injured ARDS patients before and one hour after prone positioning (normal ranges: 48 to 72 cm/s)."
15726686|NCT05050812|Device|grounding mat|Participants will sleep on an Earthing Elite sleep mat produced and sold by Earthing.com
15726687|NCT05050799|Device|Central Venous Access|The Surfacer® Inside-Out® Access Catheter System is intended to obtain central venous access to facilitate catheter insertion into the central venous system for patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods.
15726688|NCT05050786|Device|Negative Wound Pressure Therapy (Prevena(TM))|After skin closure, NPWT in the form of Prevena™ (KCI/Acelity, San Antonia, TX, USA) is applied using the following technique: The sterile foam dressing is removed from the package and placed on the incision in the entire length, on top of which the sterile dressing is placed, ensuring air tightness. An appropriate hole in the dressing is cut at the center of the dressing and the tube for the interface pad is connected and a negative pressure of 125mmHg is applied. The Prevena™ system is removed on the morning of postoperative day 3.
15726689|NCT05050786|Other|Standard Wound Dressing|After skin closure, a standard operative dressing is applied in the entire length of the incision. This operative dressing is removed in the morning of postoperative day two. Only in the case of blood or serous fluid mandating changing of the dressing, will this be done prior to postoperative day 2.
15726690|NCT05050760|Drug|Camrelizumab|Camrelizumab 200mg IV D1，Q3W,and preoperative therapy with three cycles.
15726691|NCT05050760|Drug|DCF|DCF:Oxaliplatin (85mg/ m^2, IV D1,Q3W.Docetaxel: 60 mg/m^2 intravenous infusion for 60 minutes, D1,Q3W.Tegafur:BSA<1.25^2,40 mg/time,1.25^2<BSA<1.5^2,50 mg/time,BID ,after breakfast and dinner, continuous administration for 14 days, rest for 7 days, as a treatment cycle;Repeat every 3 weeks
15726692|NCT05050747|Drug|hCG|endometrial injury by pipelle on day 8-9 of the same cycle of ovulation induction
15726693|NCT05050734|Behavioral|Comprehensive Behavioral Intervention for Tics - Enhanced (CBIT-E)|Behavioral treatment for persistent tic disorders.
15726694|NCT05050721|Other|CT imaging|clinical, radiological and biochemical parameters associated with disease progression
15726695|NCT05050708|Other|Patient interview|Patient will be interviewed pre-operatively and at 24 hrs post-opartively
15726697|NCT05050669|Other|No Intervention for this observational study|No Intervention for this observational study
15726698|NCT05050656|Drug|Duloxetine 60mg|Duloxetine is a selective SNRI prescribed in depression, anxiety, and chronic pain like diabetic neuropathy and fibromyalgia, it acts through central and peripheral pain modulation
15726699|NCT05050656|Drug|Placebo|placebo tablets identical to duloxetine tablets
15726700|NCT05050643|Other|EBQI-IC|Individual (ongoing) consultation (IC), often described as coaching or supervision, is endorsed by implementation experts as an effective implementation strategy
15726701|NCT05050643|Other|EBQI-LC|A Learning Collaborative is a systematic approach to process improvement based on the Institute for Healthcare Improvement Breakthrough Series Collaborative model. During the Collaborative, organizations will test and implement system changes and measure their impact. They will share their experiences to accelerate learning and broader implementation of best practices.
15726702|NCT05050630|Drug|TR2-ICE|Rituximab 375 mg/m2 d0; Lenalidomide 25mg/d d1-10; Ifosfamide 5g/m2 d2; Carboplatin calculate according to AUC=5 (single dose ≤800 mg); Etoposide 100mg/m2 d1-3; Tirelizumab 200mg d6.
15726703|NCT05050617|Diagnostic Test|Point-of-care echocardiography|Subjects will undergo point-of-care echocardiography at the time of presentation/enrollment to assess for evidence of right sided heart dilation/strain.
15726704|NCT05050604|Drug|Choline Alfoscerate 400mg|Choline Alfoscerate 400mg per oral 3 times a day during the entrie treatment period
15726705|NCT05050604|Drug|Placebo of Choline Alfoscerate 400mg|Placebo of Choline Alfoscerate 400mg per oral 3 times a day during the entrie treatment period
15726706|NCT05050591|Device|Patient-Specific Silicone Airway Stent|The Patient-Specific Airway Stent is a silicone stent indicated for use in adults that have stenosis of the airway. Current silicone stents have stock dimensions that do not conform to the patient's airway anatomy. The subject device takes a CT scan, thresholds out the airway from the other anatomy, and allows the physician to digitally design the stent to his/her desired dimensions. Finally, according to the physician's design, a patient-specific stent can be manufactured using additive manufacturing technology. The patient-specific stent is indicated for use with any rigid bronchoscopy/stent application system that fits the design envelope.
15726707|NCT05050578|Device|Lehfilcon A contact lenses|Commercially available, silicone hydrogel, spherical contact lenses used as indicated
15726708|NCT05050578|Device|Senofilcon A contact lenses|Commercially available, silicone hydrogel, spherical contact lenses used as indicated
15726709|NCT05050578|Device|CLEAR CARE|Hydrogen peroxide-based contact lens cleaning and disinfecting solution
15726711|NCT05050552|Device|Masimo Radical-7 Pulse CO-Oximeter|The Masimo Radical-7 Pulse CO-Oximeter is a device for the measurement of pulse oximetry, oxygen reserve index (ORi), perfusion index (PI), and pleth variability index (PVI). The device is the product of a company called Masimo Inc, Irvine, CA, USA
15726712|NCT05050539|Behavioral|Low Intensity|5 implementation strategies: formal commitments, local champions, implementation blueprint , remind educators (cutting board with WISE EBPs), task-focused facilitation.
15726713|NCT05050539|Behavioral|High Intensity|Low intensity implementation strategies with the addition of holistic individualized facilitation and tailored educational materials.
15726714|NCT05050526|Behavioral|Real-time videoconference-based Exercise program|12-week exercise program consisting of two weekly 45 minute group-based sessions, remotely supervised by a professional via real-time videoconference. Each session will consist of a warm-up (5-10 min), general strengthening (30 min) and cool-down (5-10 min). Warm-up will include general joint mobility and exercises focused on increasing heart rate. General strengthening will include 4 series of 6 exercises (2 for lower limb, 2 for upper limb and 2 for the trunk) performed with minimal equipment, combining body-weight and elastic-band exercises. Three difficulty levels will be set for each of the exercises, and progression will be made at weeks 5 and 9. Participants will be asked to work in a given rate of perceived exertion (between 3 and 6 in Borg's CR10 scale) and not to reach failure in any of the exercises. Cool-down will include stretching and breathing/relaxing exercises.
15726715|NCT05050500|Drug|Dapagliflozin 10mg/Tab|patients meeting inclusion criteria will be randomized to receive dapagliflozin 10 mg every 24 hours for 6 months
15726716|NCT05050500|Drug|Placebo|patients meeting the inclusion criteria will be randomized to receive a placebo tablet every 24 hours for 6 months.
15726717|NCT05050487|Procedure|PENG block|"The PENG block is performed under US guid¬ance, . The pa¬tient is placed in the supine position a curvilinear low-fre¬quency ultrasound probe (2-5 MHz) is initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe approximately 30-45 degrees . .
~The needle, usually a 22-G80-mm echogenic device, is inserted from lateral to medial with an in-plane approach to place the tip in the plane between the psoas tendon anteriorly and the pu¬bic ramus posteriorly .
~After needle insertion and following negative aspiration, the local anesthetic is injected . The volume used of 20 ml of(L-bupivacaine; concentration 0,25% ) . This fascial plane appeared to continue in the hip pericapsular plane."
15726990|NCT05048706|Device|Laser lithotripsy (SP TLF)|Laser lithotripsy of urinary calculi using the Super Pulse Thulium fiber laser (SP TLF)
15726718|NCT05050487|Procedure|lumbar paravertebral nerve block|"Lumbar paravertebral region is obtained after positioning the probe 3-4 cm lateral and parallel to the lumbar spinous process. After identifying of the L5 transverse process, L4,3,2 transverse processes were identified by counting from downward to upward. The trident sign is identified by the ultrasound. It presents the acoustic shadow of the transverse processes. The psoas muscle was localized by being in the space between the transverse processes shadow. Nerves of the lumbar plexus are identified as the longitudinal hyperechoic structures seen on the posterior aspect of the psoas major muscle.. Upon entry of the needle to the posterior aspect of the psoas major. After negative aspiration, the local anesthetic (20mL of bupivacaine 0.25% ) was injected slowly in the third lumbar paravertebral space, and patients were closely monitored for any signs of inadvertent intravenous injection."
15726719|NCT05050474|Biological|Recombinant SARS-CoV-2 Fusion Protein Vaccine|The product should be a milky-white suspension for injection. For prevention of SARS-CoV-2 infection.
15726720|NCT05050461|Other|Immunological analyses|Immunological analyses will be performed at inclusion in both arms
15726721|NCT05050448|Device|Sustained Acoustic Device with 2.5% Diclofenac Patch|Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours of continuous therapeutic ultrasound at 3 megahertz(MHz) frequency and 0.132 Watts/cm@ with 2.5% Diclofenac patches.
15726722|NCT05050448|Drug|1% Diclofenac Topical Gel|Topical pain-relief gel
15726723|NCT05050435|Procedure|Early extubation|Patients of the 2 groups are extubated at different moments: either immediately postoperatively, in the operating room, or after a few hours monitoring in ICU
15726724|NCT05050422|Diagnostic Test|Trunk Impairment Scale (TIS), PedsQLTM Multidimensional Fatigue Scale (PedsQL-MFS), Pediatric Balance Scale (PBS)|control/study group
15726725|NCT05050409|Behavioral|Brief mindfulness|A 15-minute guided mindfulness practice that includes focused attention on breath and body sensations and open monitoring and acceptance of thoughts, emotions, and pain.
15726726|NCT05050409|Behavioral|Mindfulness-Oriented Recovery Enhancement (MORE)|An 8-session intervention. Sessions involve: 1) mindfulness training to reduce pain and increase self-regulation over opioid use, 2) cognitive reappraisal to decrease psychological distress, and 3) savoring to augment natural reward processing, positive emotion, and esprit de corps.
15726727|NCT05050409|Other|Standard care|Preoperative Standard Care. Patients will attend a 2-hour preoperative class involving pain coping education and are offered prehabilitation services. Postoperative standard care includes (1) pain medications to minimize opioid use, including acetaminophen, lyrica, meloxicam/naproxen and celebrex, and (2) anticoagulants for 3-6 weeks postoperatively, as well as (3) ambulatory care with assistive devices 1-6 weeks after surgery. Patients see their surgeon postoperatively 2-6 weeks after surgery, 3-6 months, and yearly.
15726728|NCT05050396|Procedure|Cooled versus thermocoagulant Radiofrequency Ablation in pain relief of knee osteoarthritis|Radiofrequency (RF) ablation, or modulation of the sensory innervation surrounding the knee, specifically the genicular nerves (GNs), has emerged as a therapeutic option to treat chronic knee OA pain for patients who are unresponsive to conservative treatments or are unsuitable candidates for total knee arthroplasty (TKA). [16, 17] Similar to conventional RFA, water-cooled radiofrequency (CRF) ablation is a novel technology that utilizes thermal ablative mechanisms; however, CRF gives the ability to create a greater local neuronal lesion to increase the changes of effective denervation [20]
15726729|NCT05050383|Other|Pharyngeal Manometry|Catheters will be passed into the nose and advanced to the pharynx to measure airway pressures during drug-induced sleep.
15726730|NCT05050383|Other|Submental Ultrasound|Ultrasound of airway soft tissues
15726731|NCT05050370|Behavioral|Brief messaging and personalized support|Patients will receive (i) a face-to-face group session and a package of instant messages related to lifestyle-integrated exercise (including breathing, balance, aerobic, strength, stretching exercises), cancer-related care information and support.
15726732|NCT05050357|Device|Hormonal intrauterine device|insertion of hormonal IUD during menstrual period
15726733|NCT05050357|Drug|Progestins Norethindrone|oral ethisteron twice daily for three months
15726734|NCT05050331|Procedure|Muscle Energy Technique|Muscle energy technique (MET) is an active manipulative technique that requires patient active muscle contraction of a respective muscle from a specific position in a specific direction with 10-20 percent force exerted by the patient which is resisted by the therapist in an attempt to relax and lengthen the muscle.
15726735|NCT05050331|Procedure|Trigger Point Release|In trigger point release, a vertical downward pressure toward the trigger point for 90 seconds is applied with the therapist's thumb. Three repetitions needed to be done with 30 seconds relaxation time. After that, 3 longitudinal strokes in caudal to cranial direction are given by therapist's thumb over the taut band.
15726736|NCT05050331|Procedure|Self-Stretching of Calf and Plantar Fascia|Self-stretching will be done 5 times twice a day with 20 seconds of intermittent stretch and 20 seconds relaxation time.
15726737|NCT05050318|Biological|Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2021-2022 formulation|Suspension for injection in a pre-filled syringe Route of administration: Intramuscular (IM)
15726738|NCT05050318|Biological|Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2021-2022 formulation|Suspension for injection in a pre-filled syringe Route of administration: Intramuscular (IM)
15726739|NCT05050305|Drug|Marizomib|Intravenous Infusion
15726740|NCT05050305|Drug|Pomalidomide|Taken orally
15726741|NCT05050305|Drug|Dexamethasone|Taken orally
15726742|NCT05050292|Other|Personalized cognitive stimulation|Online gamified activities designed to stimulate cognitive functions (specifically executive function) will be carried out through a mobile application or web browser. Each day, the participants will perform a total of 4 activities. Each activity lasts approximately 3 minutes. Performance feedback will be shown after each activity.
15726743|NCT05050292|Other|Sham cognitive stimulation|Non-therapeutic online games. Each day, the participants will perform a total of 4 games. Each game lasts approximately 3 minutes. Performance feedback will be shown after each game.
15726744|NCT05050279|Drug|Delgocitinib capsule|oral capsule
15726745|NCT05050279|Drug|Placebo capsule|oral capsule
15726746|NCT05050266|Behavioral|Diabetes Prevention Program (DPP)|Virtual Diabetes Prevention Program, an evidence-based lifestyle intervention, emphasizing moderate weight loss, diet, and physical activity, that has been shown to prevent and/or delay progression to type 2 diabetes
15726747|NCT05050266|Behavioral|Reach Out, stay Strong, Essentials (ROSE)|Reach Out, stay Strong, Essentials (ROSE) an evidence-based intervention for prevention of perinatal depression that can be delivered via telehealth.
15726748|NCT05050266|Behavioral|Telephone Lifestyle Coaching Program (TLC)|Telephone Lifestyle Coaching Program (TLC), evidence-based virtual (telephone-based), individual-level, personalized health coaching focused on wellness and cardiovascular disease prevention.
15726749|NCT05050253|Device|Super-oxidized solution (SOS)|Peritoneal lavage with super-oxidized solution in patients undergoing emergency abdominal surgery for secondary peritonitis.
15726750|NCT05050253|Device|Ringer's lactate|Peritoneal lavage with Ringer's lactate in patients undergoing emergency abdominal surgery for secondary peritonitis.
15726751|NCT05050240|Other|Cooling Vest Procedure|"A cold vest will be placed on the participant (consisting of a water-perfused CFA wearable vest, size S-M or M-L with adjustable straps Polar Products, Stow, OH; attached to a small 'cooler' reservoir to circulate cold water between the vest and the cooler; Product link: https://www.polarproducts.com/polarshop/pc/CoolOR-13-Quart-System-with-Arctic-Chiller-p24757.htm This product is safe and recommended by experimental guidelines and BARCIST criteria for human BAT studies. Note, the cooling vest will be cleaned between participants according to the manufacturer's guidelines found here: https://www.polarproducts.com/polarshop/pc/catalog/pdf/Polar_CoolFlow_Manual.pdf.
~Briefly, the vest will be hand washed with a mild detergent and warm soapy water and air-dried. The vest will then be stored in a clean, dry environment with ventilation."
15726752|NCT05050227|Behavioral|cCBT Enhanced Collaborative Care|"Computerized CBT (cCBT) will be delivered supported by a depression care manger who will facilitate access to cCBT, promote and monitor cCBT use, reinforce CBT concepts (during outside CBT session homework), and monitor mental health symptoms for each participant."
15726753|NCT05050227|Behavioral|Usual Care|Primary Care Provider supported usual care typically includes medication prescription and referrals to specialty mental health, including Primary Care - Mental Health Integration services.
15726754|NCT05050214|Drug|Obinutuzumab|Each patient will be treated for 1 month and received a total of 3 doses. The first dose of Obinutuzumab (1000 mg) will be split in two separate infusions; on the first day each patient will receive 100 mg and the next day 900 mg of Obinutuzumab. Obinutuzumab (1000 mg) will be also administered at two and four weeks after the first infusion. Obinutuzumab will be administered after standard premedication.
15726755|NCT05050201|Device|Sleepio|Digital CBT application for insomnia
15726756|NCT05050188|Drug|H008|Drug administration after a minimum 10-hour overnight fasting. Subjects will be instructed to take the drugs with approximately 240 ml (8 oz) room temperature water.
15726757|NCT05050188|Drug|H008 placebo|Drug administration after a minimum 10-hour overnight fasting. Subjects will be instructed to take the drugs with approximately 240 ml (8 oz) room temperature water
15726758|NCT05050188|Drug|Lansoprazole|Drug administration after a minimum 10-hour overnight fasting. Subjects will be instructed to take the drugs with approximately 240 ml (8 oz) room temperature water
15726759|NCT05050162|Drug|Cisplatin|Given high-dose cisplatin IV
15726760|NCT05050162|Drug|Cisplatin|Given low-dose cisplatin IV
15726761|NCT05050162|Other|Quality-of-Life Assessment|Ancillary studies
15726762|NCT05050162|Other|Questionnaire Administration|Ancillary studies
15726763|NCT05050162|Radiation|Radiation Therapy|Undergo radiation therapy
15726764|NCT05050149|Drug|PTX-022|Safety and Efficacy of PTX-022 in the Treatment of Microcystic Lymphatic Malformations
15726765|NCT05050136|Drug|Volixibat|Oral capsules, administered twice daily. Volixibat is an apical sodium-dependent bile acid transporter (ASBT) inhibitor.
15726766|NCT05050136|Drug|Placebo|Capsules matched to study drug without the active pharmaceutical ingredient
15726769|NCT05050110|Other|Fruits and Vegetable increase|Increase fruits and vegetable consumption in chronic Kidney Patients to maintain Normokalemia
15726770|NCT05050097|Drug|Talquetamab|Talquetamab will be administered subcutaneously.
15726771|NCT05050097|Drug|Carfilzomib|Carfilzomib will be administered as an IV infusion.
15726772|NCT05050097|Drug|Daratumumab SC|Daratumumab will be administered subcutaneously.
15726773|NCT05050097|Drug|Lenalidomide|Lenalidomide will be self-administered orally.
15726774|NCT05050097|Drug|Pomalidomide|Pomalidomide will be self-administered orally.
15726775|NCT05050084|Drug|Bicalutamide|Anti-androgen
15726776|NCT05050084|Drug|Buserelin|GnRH agonist
15726777|NCT05050084|Drug|Darolutamide|Anti-androgen
15726778|NCT05050084|Drug|Degarelix|GnRH antagonist
15726779|NCT05050084|Drug|Flutamide|Anti-androgen
15726780|NCT05050084|Drug|Goserelin|GnRH agonist
15726781|NCT05050084|Drug|Histrelin|GnRH agonist
15726782|NCT05050084|Drug|Leuprolide|GnRH agonist
15726783|NCT05050084|Radiation|Radiation Therapy|Undergo RT
15726784|NCT05050084|Drug|Relugolix|GnRH antagonist
15726785|NCT05050084|Drug|Triptorelin|GnRH agonist
15726786|NCT05050071|Drug|Allium Sativum|Sixty-six permanent mature necrotic incisors associated with apical periodontitis in male children were selected. Teeth were randomly divided into three groups (n=22) according to intra canal medications used; group I: Ca OH2, group II: garlic extract and group III: mixture of Ca OH2 and garlic extract. After access preparation, four microbiological samples (S) were as follows; (S1): were taken before canal instrumentation and irrigation. (S2): after cleaning and shaping, Then, the third samples (S3) and forth samples (S4) were taken after placement of the tested intracanal medications into the corresponding canals, for 7 and 14 days respectively. Total DNA was extracted from microbiological samples and relative quantitive real time PCR reactions were done to quantify the relative gene expression levels (FC) for Streptococcus and Enterococcus faecalis species.
15726787|NCT05050071|Device|Polymerase chain reaction|Change in the bacterial load in response to different treatment procedures
15726991|NCT05048706|Device|Laser lithotripsy (Ho:YAG)|Laser lithotripsy of urinary calculi using the standard Holmium: Yttrium-Aluminium-Garnet (Ho:YAG) laser.
15726788|NCT05050006|Biological|ITIL-168|ITIL-168 is a cell therapy product derived from a patient's own TILs. A tumor sample is removed from each patient to make a personalized ITIL-168 product. Once ITIL-168 has been made, the patient is treated with 5 days of lymphodepleting chemotherapy including cyclophosphamide and fludarabine, followed by a single infusion of ITIL-168, and up to 8 doses of IL-2.
15726789|NCT05049993|Device|Aequalis Pyrocarbon Humeral Head|Hemi Shoulder Arthroplasty using the Aequalis Pyrocarbon Humeral Head
15726790|NCT05049980|Drug|Medical treatment with Mifégyne® and MisoOne®|When participants arrive for their uterine emptiness check-up, 12 days after treatment, patients will be asked to drop off the study questionnaire the same day in a box provided for this purpose in the department.
15726791|NCT05049980|Procedure|Endo-uterine aspiration|When patients arrive in hospital on the day of the surgery, participants will be asked to complete a questionnaire at home 1 week after surgery and return it to investigators.
15726792|NCT05049954|Other|Calorie-Restricted Healthy Ketogenic Diet|Participants in the experimental group will be advised on a Calorie-restricted Healthy Ketogenic Diet via 7 workshops. Participants will also be advised to monitor their urinary ketones to track compliance.
15726793|NCT05049954|Other|Calorie-Restricted Low Fat Diet|Participants will be advised on Calorie-restricted Low Fat diet via 7 workshops.
15726794|NCT05049941|Diagnostic Test|lactat and blood gases|observational
15726795|NCT05049928|Other|Telerehabilitation solution (m-Rehab)|"The telerehabilitation program consists of the following elements:
~Mobile applications and website usable on smartphone and tablet for the patient.
~Teleconsultation solution for the patient and the doctors.
~Video conferencing solution for professionals involved in patient follow-up: educators in adapted physical activity, physiotherapists, psychologists, dieticians, etc.
~Web interface for health professionals allowing the collection and monitoring of various parameters in physical activity and nutrition as well as progress in therapeutic education activities.
~Withings® connected objects"
15726796|NCT05049915|Device|bioglass (S53P4)|surgical procedure: Masquelet defect augmentation with bioglass
15726797|NCT05049915|Device|RIA and TCP|surgical procedure: Masquelet defect augmentation with RIA and TCP
15726805|NCT05049889|Other|Terrestrial exercise|"At visit 1 (Day 0), an exercise test will be performed (maximal incremental test), followed by a 30-minute submaximal exercise at constant load.
~During this exercise, continuous data collection will be performed:
~Continuous 12-lead electrocardiogram
~Continuous monitoring of blood pressure and ventilation."
15726806|NCT05049889|Other|Swimming exercise|"At visit 2 (Day 7), the subjects will perform a swimming exercise in the experimental pool equipped with a turbine to create a counter-current. The water speed will be constant (4 min per 100 m, i.e. 1.5 km/h). The duration of the exercise will be 30 minutes. Each diver will breathe with the help of a snorkel.
~During this exercise, continuous data collection will be performed:
~Continuous 12-lead electrocardiogram
~Continuous monitoring of blood pressure and ventilation."
15726807|NCT05049889|Device|Transthoracic cardiac ultrasound|The participants will have a transthoracic cardiac ultrasound to measure the dilatations of the cardiac cavities at visit 1 and 2.
15726808|NCT05049889|Device|Transthoracic pulmonary ultrasound|The participants will have a transthoracic pulmonary ultrasound to quantify the presence of signs of pulmonary vascular overload (comet tails) at visit 1 and 2.
15726809|NCT05049889|Biological|Blood collection|Several blood samples will be collected at visit 1 and 2.
15726810|NCT05049876|Other|urine sample taken during consultations|urine sample taken during consultations
15726811|NCT05049863|Drug|Mycophenolate Mofetil|Mycophenolate mofetil is commercially available.
15726812|NCT05049863|Drug|Allopurinol|Allopurinol is commercially available.
15726813|NCT05049863|Drug|Irinotecan|Irinotecan is commercially available.
15726814|NCT05049850|Drug|Imlifidase|Imlifidase is an immunoglobulin G (IgG)-degrading enzyme of Streptococcus pyogenes that is highly specific for IgG.
15726815|NCT05049837|Other|Group Specific Aim 1|600 cases: two normal and two tumor formalin-fixed tissue samples
15726816|NCT05049837|Other|Group Specific Aim 2|600 cases: two normal and two tumor formalin-fixed tissue samples.
15726817|NCT05049837|Other|Group Specific Aim 3|600 cases, including 150 patients who had received neoadjuvant therapy and 450 patients who had not. Two normal and two tumor formalin-fixed tissue samples
15726818|NCT05049837|Other|Group Specific Aim 4|600 cases; including 150 patients who will receive neoadjuvant chemotherapy, 150 patients who received or will receive postoperative adjuvant chemotherapy, and 300 patients who did not receive or will not receive neoadjuvant or adjuvant chemotherapy. Two normal and two tumor formalin-fixed tissue samples
15726819|NCT05049837|Other|Group Specific Aim 5|600 cases; two normal and two tumor formalin-fixed tissue samples
15726820|NCT05049837|Other|Group Specific Aim 6|210 cases (of the 600 above), one normal and one tumor formalin-fixed histology sections obtained from formalin-fixed and paraffin- embedded tissue samples.
15726821|NCT05049824|Device|Self Forming Magnetic (SFM) Anastomosis System|The SFM will be placed using an endoscope in the duodenum and laparoscopically into the ileum. A compression anastomosis will be created in each of the subjects and the diversion of enteral flow from the duodenum to ileum will create a metabolic effect that will induce weight loss and impact metabolic disease indicators
15726822|NCT05049811|Behavioral|mini program|To design, construct, and test the mini program in patients managing cancer pain
15726823|NCT05049811|Behavioral|conventional pharmaceutical care|Regular education includes medication guidance from doctors, nurses and pharmacists.
15726992|NCT05048680|Procedure|Hypoxia and/or Exercise|Hypoxia at rest versus normoxia at rest; Hypoxia during exercise versus Normoxia during exercise.
15726826|NCT05049785|Other|Counseling|Attend nutrition counseling sessions
15726827|NCT05049785|Behavioral|Exercise Intervention|Complete PA sessions
15726828|NCT05049785|Other|Informational Intervention|Receive nutrition handouts
15726829|NCT05049785|Dietary Supplement|Nutritional Intervention|Attend tasting sessions
15726830|NCT05049785|Other|Questionnaire Administration|Ancillary studies
15726831|NCT05049772|Behavioral|Telerehabilitation-based motor imagery training|10 weeks of motor imagery training and stabilization exercises.
15726832|NCT05049772|Behavioral|Stabilization exercises group|10 weeks of stabilization exercises.
15726833|NCT05049759|Behavioral|Confident, Active and Happy Youth|The three target goals of the intervention (confident, active and happy) link closely to the core symptoms of internalizing disorders. Thus, a core symptom of anxiety is a lack of confidence in one's ability to cope with a given fearful situation. The ensuing behavioral reaction is avoidance of the situation and/or enduring it with excessive discomfort. Similarly, a core symptom of a depressive disorder is lowered mood. Regarding both depression and anxiety, both disorders are associated with less physical activity, and low levels of physical activity conversely help maintain the disorders. As such, the aim is to alleviate symptoms and supplement ongoing treatment in CAMHS.
15726834|NCT05049746|Other|Discussion|Participate in discussion
15726835|NCT05049746|Other|Interview|Participate in interview
15726836|NCT05049746|Other|Questionnaire Administration|Complete questionnaire
15726837|NCT05049733|Drug|CBD 1mg/Kg|Participants will ingest soft gel tablets containing CBD 1mg/Kg
15726838|NCT05049733|Drug|CBD 2mg/Kg|Participants will ingest soft gel tablets containing CBD 2mg/Kg
15726839|NCT05049733|Drug|CBD 4mg/Kg|Participants will ingest soft gel tablets containing CBD 4mg/Kg
15726840|NCT05049733|Drug|Placebo CBD|Participants will ingest soft gel tablets containing placebo for CBD
15726841|NCT05049720|Device|Defibrillation using the Extravascular ICD|VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing.
15726842|NCT05049707|Drug|IV magnesium sulfate|10 grams magnesium in 250 cc normal saline
15726843|NCT05049707|Other|Placebo|250 cc normal saline delivered in equivalent rates as the treatment group
15726844|NCT05049694|Device|zirconia crowns|esthetic crowns for capping permanent molars with caries
15726845|NCT05049694|Device|stainless steel crowns|stainless steel crowns for capping permanent molars with caries
15726846|NCT05049681|Drug|Camrelizumab|SHR-1210（Camrelizumab） 200 mg，Intravenous injection， q2W ，A course of treatment need 28 days.
15726847|NCT05049681|Drug|Apatinib|Apatinib 250mg, q.d.po
15726848|NCT05049668|Drug|ATGAM plus CsA with or without Eltrombopag|Standard treatment with or without Eltrombopag
15726849|NCT05049655|Other|Study Formula|Babies who were fed study formula during the SS-101-18 study
15726850|NCT05049655|Other|Comparator Formula|Babies who were fed commercial formula during the SS-101-18 study
15726851|NCT05049655|Other|Human Milk|Babies who were breastfed during the SS-101-18 study
15726852|NCT05049642|Device|Lacrimera|A new preservative-free formulation of eye drops consists of a novel biopolymer, chitosan-N-acetylcysteine (C-NAC; Lacrimera®, Croma-Pharma GmbH, Leobendorf, Austria), which electrostatically binds to the mucine layer of the tear film forming a glycocalyx-like structure.
15726853|NCT05049629|Device|Lacrimera|A new preservative-free formulation of eye drops consists of a novel biopolymer, chitosan-N-acetylcysteine (C-NAC; Lacrimera®, Croma-Pharma GmbH, Leobendorf, Austria), which electrostatically binds to the mucine layer of the tear film forming a glycocalyx-like structure.
15726854|NCT05049629|Device|Hylo-Vision|Preservative-free, Hyaluronic-acid containing eyedrops (Hylo-Vision® sine)
15726857|NCT05049603|Drug|Atorvastatin 20mg|One tablet/day, given approximately at 10 pm, after dinner and before going to bed, for 24 weeks
15726858|NCT05049603|Other|Placebo|One tablet/day, given approximately at 10 pm, after dinner and before going to bed, for 24 weeks
15726860|NCT05049577|Device|Analgesia/Nociception Index (ANI)|V1 and V5 electrocardiographic positions as per the manufacturer's recommendations. The ANI was continuously recorded and displayed with a frequency of 1 Hz. ANI scores measured immediately before propofol administration, half-dose administration (1mg/kg), and full-dose administration (2mg/kg)of propofol.
15726861|NCT05049564|Procedure|keyhole microneurosurgery|microsurgical clipping via keyhole approach
15726862|NCT05049564|Procedure|conventional microneurosurgery|microsurgical clipping via conventional craniotomy
15726863|NCT05049564|Procedure|endovascular coiling|endovascular coiling via femoral approach
15726864|NCT05049538|Procedure|Biospecimen Collection|Undergo collection of blood and tissue samples
15726865|NCT05049538|Procedure|Liquid Biopsy|Undergo liquid biopsy
15726866|NCT05049538|Other|Pap Smear|Undergo Pap smear
15726867|NCT05049525|Drug|Itraconazole 400 mg/day and terbinafine 500 mg/day administered orally.|Itraconazole capsules of 100 mg, antifungal agent. Terbinafine tablets 250 mg (as terbinafine hydrochloride), antifungal agent.
15726868|NCT05049525|Drug|Itraconazole's matching placebo 400 mg/day and terbinafine's matching placebo 500 mg/day administered orally.|Matching placebo of itraconazole capsules of 100 mg, antifungal agent. Matching placebo of terbinafine tablets 250 mg, antifungal agent.
15726869|NCT05049512|Other|Multi-nut OIT|Finely ground pure peanut, almond, cashew, hazelnut, and walnut.
15726870|NCT05049486|Radiation|CT scan|Patients will undergone a pelvic CT scan.
15726871|NCT05049473|Drug|Rituximab|Rituximab 375 mg/m² IV. Day 1. Cycles: A1/A1*, B1/B1*, C1/A2*, A2/B2*, B2/A3*, C2/B3*. Two additional doses after 6 cycles in case of localized stage patients without CR after four cycles or advanced stage patients.
15726872|NCT05049473|Drug|Methotrexate|Methotrexate 1500 mg/m² IV 24h-infusion. Day 2. Cycles: A1, B1, C1 (1000 mg/m² if patient in CR) , A2 (1000 mg/m² if patient in CR), B2 (1000 mg/m² if patient in CR) , C2 (1000 mg/m² if patient in CR) Methotrexate 500 mg/m² IV 24h-infusion. Day 2. Cycles: A1*, B1*, A2*, B2*, A3*, B3*
15726873|NCT05049473|Drug|Dexamethasone|Dexamethasone 10 mg/m² PO or IV bolus. Days: 2 to 6. Cycles: A1/A1*, B1/B1*, C1/A2*, A2/B2*, B2/A3*, C2/B3*.
15726874|NCT05049473|Drug|Iphosphamid|"Iphosphamid 800 mg/m² IV in 1 hour. Days: 2 to 6. Cycles: A1, A2 (500 mg/m² if patient in CR).
~Iphosphamid 400 mg/m² IV in 1 hour. Days: 2 to 6. Cycles: A1*."
15726875|NCT05049473|Drug|Vincristine|Vincristine 2 mg IV bolus. Day 2. Cycles: A1, B1, A2, B2 Vincristine 1 mg IV bolus. Day 2. Cycles: B1*, B2*, B3*
15726876|NCT05049473|Drug|Etoposide|Etoposide (VP16) 100 mg/m² IV in 1 hour. Days: 5, 6. Cycle: A1, A2. Etoposide (VP16) 250 mg/m² IV in 1 hour. Days: 5, 6. Cycle: C1, C2. Etoposide (VP16) 60 mg/m² IV in 1 hour. Days: 5, 6. Cycle: A1*, A2*, A3*.
15726877|NCT05049473|Drug|Cytarabine|Cytarabine 150 mg/m² IV in 1 hour every 12 hours. Days: 5, 6. Cycles: A1, A2 Cytarabine 2 g/m² IV in 3 hours every 12 hours. Day: 6. Cycle: C1 (1.5 g/m² if patient in CR), C2 (1.5 g/m² if patient in CR) Cytarabine 60 mg/m² IV in 1 hour every 12 hours. Days: 5, 6. Cycles: A1*, A2*, A3*
15726878|NCT05049473|Drug|Cyclophosphamide|Cyclophosphamide 200 mg/m² IV in 1 hour. Days 1 to 5. Pre-phase. Cyclophosphamide 200 mg/m² IV in 1 hour. Days 2 to 6. Cycles: B1, B2, B1*, B2*, B3*
15726879|NCT05049473|Drug|Doxorubicin|Doxorubicin 25 mg/m² IV in 15 min. Days 5 and 6. Cycles: B1/B1*, B2, B2*, B3*
15726880|NCT05049473|Drug|Vindesine|Vindesine 3 mg/m2 (max 5 mg) IV bolus. Day 2. Cycles: C1, C2
15726881|NCT05049473|Drug|Cytarabine|Cytarabine 30 mg IT. Days 2 and 6. Cycles A1, B1, A2, B2
15726882|NCT05049473|Drug|Methotrexate|Methotrexate 12 mg IT. Day 1. Pre-phase Methotrexate 12 mg IT. Days 2 and 6. Cycles: A1, B1, A2, B2 Methotrexate 15 mg IT. Day 2. Cycles: A1*, B1*, A2*, B2*, A3*, B3*
15726883|NCT05049473|Drug|Hydrocortisone|Hydrocortisone 20 mg IT. Days 2 and 6. Cycles: A1, B1, A2, B2
15726884|NCT05049473|Drug|Prednisone|Prednisone 60 mg/m2 PO or IV bolus. Days 1 to 5. Pre-phase.
15726887|NCT05049447|Drug|Pascoflair|1 x 2 tablets (single-dose)
15726888|NCT05049447|Other|Placebo|1 x 2 tablets (single-dose)
15726889|NCT05049434|Device|Medicurtain®|Medicurtain® 5ml prefilled syringe
15726890|NCT05049434|Device|GUARDIX-SG®|GUARDIX-SG® 5ml prefilled syringe
15726891|NCT05049421|Diagnostic Test|Echocardiography|Full 2D and 3D echocardiography with special focus on right ventricular function
15726892|NCT05049408|Diagnostic Test|MMP-1 Enzyme Linked Immunosorbent assay (ELISA)|The MMP-1 ELISA is to measure salivary MMP-1 levels of participants
15726893|NCT05049395|Device|High Flow Nasal Cannula oxygen (HFNO)|The AIRVO2 is set at 30L/min, FiO2 100%, and 37℃ before anesthesia induction，and then 60L/min until the end of the procedure of sedated hysteroscopy.
15726894|NCT05049395|Device|Regular oxygen|The patients are administered oxygen of 3L-6L/min until the end of the hysteroscopy operation.
15726895|NCT05049382|Procedure|Extraction of impacted mandibular third molar|surgical extraction of impacted mandibular third molar tooth
15726900|NCT05049317|Procedure|Laparoscopic FTME surgery|Nerve plane was defined as the overlying tiny membranous tissue including the nerves, the adipose tissue and the extremely tiny capillaries around the nerve. Following the TME principles, the surgical procedure of FTME was guided by the nerve plane and dissected between the proper fascia of the rectum and nerve plane (the first gap), which could ensure completeness of the nerve plane and the proper fascia of the rectum.
15726901|NCT05049304|Other|Functional olive oil|Eleven adolescents will consume OA-enriched functional olive oil. After eating the olive oil, aliquots of cubital blood will be drawn at 2 and 5 hours of the postprandial period. During that time, free access to water intake will be allowed.
15726902|NCT05049304|Other|Olive oil|Eleven adolescents will consume olive oil. After eating the olive oil, aliquots of cubital blood will be drawn at 2 and 5 hours of the postprandial period. During that time, free access to water intake will be allowed.
15726903|NCT05049291|Behavioral|telehealth advance care planning|An education information sheet containing prognosis and outcomes of acute care and intensive treatments
15726904|NCT05049278|Drug|Norepinephrine|"Continuous drug: norepinephrine 4mg * 1@ + D5W 200 mL (20 μg/mL)
~Range: 0.03 ~ 0.09 μg/kg/min (= 0.1 ~ 0.3 mL/kg/h)"
15726905|NCT05049278|Drug|Phenylephrine|"Continuous drug: phenylephrine 10mg * 5@ + D5W 200 mL (250 μg/mL)
~Range: 0.42 ~ 1.26 μg/kg/min (= 0.1 ~ 0.3 mL/kg/h)"
15726906|NCT05049265|Biological|JS007|JS007 only
15726907|NCT05049239|Behavioral|Physical training|Medium-high-intensity physical training 3 times a week, 60 min / time for 12 weeks, consisting of fitness, strength and mobility exercises with a target level of 60-90% of maximum heart rate. Two sessions per week take place in a group led by a physiotherapist and once a week the training consists of self-chosen training individually or in group.
15726908|NCT05049239|Behavioral|Physical training combined with cognitive support.|"Medium-high-intensity physical training 3 times a week, 60 min / time for 12 weeks, consisting of fitness, strength and mobility exercises with a target level of 60-90% of maximum heart rate. Two sessions per week take place in a group led by a physiotherapist and once a week the training consists of self-chosen training individually or in group.
~The cognitive support consists of person centred individual occupational therapy with focus on daily time management skills and planning and organisation in daily life, i.e. make time for physical exercise. The number of session during the intervention period depend on the participants needs and is estimated to 4-6 sessions."
15726993|NCT05048667|Device|Shock Wave therapy (SWT)|Each SWT will administer 720 shocks in the treatment arm.
15726994|NCT05048667|Drug|Platelet Rich Plasma (PRP)|5 mL PRP will be administered via intracavernous injection
15726995|NCT05048667|Other|Sham SWT|Sham SWT will be administered in the treatment arm
15726909|NCT05049226|Biological|AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) full dose|"Astrazeneca COVID-19 (ChAdOx1 AZD1222) vaccine:
~One dose (0.5 ml) contains: COVID-19 Vaccine (ChAdOx1-S* recombinant) 5 × 10^10 viral particles (vp)
~*Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike glycoprotein. Produced in genetically modified human embryonic kidney (HEK) 293 cells.
~Administer: Intramuscular (IM) injection in the deltoid muscle"
15726910|NCT05049226|Biological|Pfizer/BioNTech BNT162b2 vaccine (PF) full dose|"Pfizer-BioNTech COVID-19 (BNT162b2) vaccine:
~Diluent: 0.9% sodium chloride (normal saline, preservative-free)
~Administer: Intramuscular (IM) injection in the deltoid muscle"
15726911|NCT05049226|Biological|AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) half dose|"Astrazeneca COVID-19 (ChAdOx1 AZD1222) vaccine:
~One dose (0.5 ml) contains: COVID-19 Vaccine (ChAdOx1-S* recombinant) 5 × 10^10 viral particles (vp)
~*Recombinant, replication-deficient chimpanzee adenovirus vector encoding the SARS-CoV-2 Spike glycoprotein. Produced in genetically modified human embryonic kidney (HEK) 293 cells.
~Administer: Intramuscular (IM) injection in the deltoid muscle"
15726912|NCT05049226|Biological|Pfizer/BioNTech BNT162b2 vaccine (PF) half dose|"Pfizer-BioNTech COVID-19 (BNT162b2) vaccine:
~Diluent: 0.9% sodium chloride (normal saline, preservative-free)
~Administer: Intramuscular (IM) injection in the deltoid muscle"
15726913|NCT05049213|Drug|Carrageenan nasal spray and 1% PVP- mouthwash and gargle|"Day1 to Day7
~Intranasal spray 3 times/day, 2~3 spray/nostril/per time
~Oral gargling 3 times/day, 20cc/per time"
15726914|NCT05049174|Behavioral|Nuse-led interview and referral to municipal healthy life-centres|Usual care treatment and written information to patients and general practitionnaires about smoking cessation and the municipal healthy life-centres
15726915|NCT05049161|Drug|Temelimab 18 mg/kg|temelimab 18 mg/kg will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total)
15726916|NCT05049161|Drug|Temelimab 36mg/kg|temelimab 36 mg/kg will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total)
15726917|NCT05049161|Drug|Temelimab 54 mg/kg|temelimab 54 mg/kg will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total)
15726918|NCT05049148|Other|Platelet count in excised tumors|Tumors excised in patients requirering a brain or medullary surgery will be assess to determine their platelet count.
15726919|NCT05049135|Device|Somnofy® sleep monitor|Registration of sleep score and apneas with radar sensor technology at time of primary investigation and 12 weeks after treatment initiation with continuous positive airway pressure (CPAP)
15726920|NCT05049122|Drug|Dupilumab SAR231893|Pharmaceutical form: solution for injection Route of administration: subcutaneous (SC)
15726921|NCT05049109|Behavioral|Integrated Telehealth After Stroke Care|"• 3 week and 8 week follow up visits with pharmacy through telehealth
~Patients will provide home blood pressure monitoring kits at discharge for the first three months. The telemonitor that can send blood pressure readings, wirelessly or through telephone, to a secure server where study staff can look at the readings. Any blood pressure readings that are not within normal range will trigger an alert to be sent to study staff who will then follow up with the patient. A trained staff member will show the patient how to use the blood pressure monitor. Patients will be asked to take blood pressure at least 3 days per week and transmit the readings to study staff.
~Patients will also be asked to wear an activity monitor starting at 4 weeks."
15726922|NCT05049109|Behavioral|Usual post-stroke follow-up care|"1-2 weeks follow up visit with primary care.
~4-6 week and 12 week follow up visit with stroke practitioner
~At the end of the study, patients will be asked questions regarding their experience with the telehealth visits, health, medication taking and quality of life"
15726923|NCT05049096|Device|focused power ultrasound mediate inferior perirenal adipose tussue modification|"This novel focused power ultrasound is an externally delivered, completely noninvasive focused therapeutic ultrasound device. It is capable of focusing the resulting ultrasound beam to a small cigar-shaped volume and monitoring the temperature of the target area, which leads to the rapid elevation of the peri-renal adipose tissue temperature and the destruction of target tissue eventually."
15726924|NCT05049096|Device|sham-control group|participants will receive the sham control therapy(including peri-renal fat ultrasonic measurement and localization,focused ultrasound treatment parameters setting),however,without initiating the focused ultrasound equipment.
15726925|NCT05049083|Drug|New Specification SHR2554 tablet、Former Specification SHR2554 tablet|New Specification, 350 mg SHR2554 tablets on study day 1 - Former Specification, 350 mg SHR2554 tablets on study day 8
15726926|NCT05049083|Drug|Former Specification SHR2554 tablet、New Specification SHR2554 tablet|Former Specification, 350 mg SHR2554 tablets on study day 1 - New Specification, 350 mg SHR2554 tablets on study day 8
15726927|NCT05049070|Diagnostic Test|Mobile medical application to self administer a subjective refraction test|GoEyes is a software as a medical device and mobile medical application, which is downloaded to a smartphone and is a self-administered subjective refraction test that measures the refractive error of the user's eyes in the home environment without any contact or help from health care professionals
15726928|NCT05049070|Diagnostic Test|Standard of care refraction test|Standard of care subjective manifest refraction test performed by a healthcare professional
15726929|NCT05049057|Drug|Erenumab 140 Mg/mL Subcutaneous Solution|Active erenumab delivered via subcutaneous injection.
15726930|NCT05049057|Drug|Placebo|Placebo delivered via subcutaneous injection.
15726931|NCT05049044|Other|Quality of Life Questionnaire-Core 30 (QLQ-C30)|The HR-QoL evaluation is based on three self-assessment questionnaires distributed to the patients according to the pre-specified data collection schedule. Patients will also complete an additional questionnaire on socio-economic and occupational outcomes
15726932|NCT05049031|Other|Questionnaire|A questionnaire will be given to patients who will ask them about their possible fractures, their bone and oncological follow-ups and their possible cardiovascular events since the end of treatment with hormone therapy.
15726933|NCT05049018|Other|Traditional Physical Therapy Program|"This intervention included:
~Strengthening and facilitation exercises for the affected upper extremity muscles.
~Stretching and mobilization exercises for the affected upper extremity muscles and joints.
~Postural reactions exercises.
~Facilitation of arm-reaching and arm-hand skills for the affected upper extremity.
~Facilitation of manipulative tasks (grasp and release activities) for the affected upper extremity.
~Training of daily living activities for the upper extremities."
15726996|NCT05048667|Other|Placebo Saline|5 mL Placebo saline will be administered via intracavernous injection
15726934|NCT05049018|Device|ArmeoSpring Virtual Reality Device (Upper Extremity Training Device with Virtual Reality Technology)|ArmeoSpring virtual Reality Equipment is a functional upper extremity rehabilitation device that provides specific therapy with augmented feedback. The ArmeoSpring instrument facilitates intensive task-oriented upper extremity therapy after stroke, traumatic brain injury, or other neurological diseases and injuries. It combines adjustable arm support, with augmented feedback and a large 3 D workspace that allows functional therapy exercises in a virtual reality environment.
15726935|NCT05049005|Behavioral|Simplified dietary tracking|Mobile-delivered nutrition program using simplified dietary monitoring with a focus on weight loss.
15726939|NCT05048966|Behavioral|Group Wellness Class 1|Twelve weekly online group wellness sessions for individuals with the disability and their support person. Each class will last for approximately 2 hours.
15726940|NCT05048966|Behavioral|Group Wellness Class 2|Twelve weekly online group wellness sessions for individuals with the disability and their support person. Each class will last for approximately 2 hours.
15726941|NCT05048953|Diagnostic Test|Muscle ultrasound measurements (the index test)|"The following parameters will be measured by muscle ultrasound
~Muscle thickness
~Muscle echogenicity
~Muscle fasciculations"
15726942|NCT05048940|Biological|Janssen vaccine|0.5 ml millilitre(s) Intramuscular use
15726943|NCT05048940|Biological|Spikevax (Moderna) vaccine|0.5 ml millilitre(s) Intramuscular use
15726944|NCT05048914|Drug|Ibuprofen|treatment of acute migraine attack
15726945|NCT05048901|Drug|Cabozantinib|Oral Cabozantinib 40-60 mg daily .every 4 weeks as a cycle
15726946|NCT05048901|Drug|Lanreotide|Lanreotide 120 mg deep SC on day 1 every 4 weeks.every 4 weeks as a cycle
15726954|NCT05048862|Diagnostic Test|Neuromuscular ultrasound|Ultrasound will be performed with the Affiniti 70 (Philips Medical Instruments, Bothell, WA). all patients following standardized methods of our hospital. All the patient would be checked the skin surface temperature before the ultrasound examination. The image would be exported from the echo machine as DICOM format.
15726955|NCT05048862|Diagnostic Test|Muscle MRI|Muscle MRI will be performed on a 3-T MR machine (Trio; Siemens, Erlangen, Germany). Each subject will lie in a supine position comfortably, supplied with ear plugs. A high resolution T1 weighted scan and Short-T1 Inversion Recovery series (STIR) of the four limbs muscle were obtained in axial and coronal plane. MR spectroscopy in interested muscle was also sampled to evaluate the composition of fat, water, lactate, and other studied molecules.
15726956|NCT05048862|Diagnostic Test|Nerve conduction studies and autonomic function tests|Nerve conduction study will be performed with a Nicolet Viking IV Electromyographer (Madison, WI) in all patients following standardized methods recommended by the Consensus Development Conference on Standardized Measures in Diabetic Neuropathy. Studied nerves include sural, peroneal, tibial, median and ulnar (motor and sensory) nerves.Autonomic functions will be assessed by the SSR and RRIV with established protocol by using Nicolet Viking IV Electromyographer (Madison, WI).
15726957|NCT05048862|Diagnostic Test|Quantitative sensory test|Quantative sensory test will be performed with a Thermal Sensory Analyzer and Vibratory Sensory Analyzer (Medoc Advanced Medical System, Minneapolis, MN). The procedure is the same as previously described 25. Briefly, the machine delivers to the patient a stimulus of constant intensity which is pre-set by the algorithm. By adjusting the intensity of stimulus (increase or decrease the intensity by a fixed ratio) according to the response of the subject (i.e. whether the subject perceives the stimulus or not), sensory thresholds of the warm, cold and vibratory modalities will be measured.
15726958|NCT05048862|Diagnostic Test|Skin biopsy|A skin specimen of 3 mm in diameter will be taken with a biopsy punch from the lateral side of the distal leg under 2% lidocaine local anaesthesia 26. No suturing is required, and the wounds are covered with a piece of gauze. Wound healing takes 7~10 days, similar to a typical abrasion wound. Informed consent will be obtained from each patient before the skin biopsy. The intraepidermal nerve fiber density and sweat gland nerve innervation will be examined.
15726997|NCT05048641|Other|Whatsapp reminder|Subjects who are allocated to the intervention group received reminder via WhatsApp Messenger at one month before the scheduled calendar month of biannual mammography follow-up.
15726998|NCT05048628|Other|Comparıson|"Only evaluation will be made at 0, 4, 6, and 8 hours after surgery without intervention in the control group.
~For other groups; Evaluation will be made at the 0th hour after the operation without application. The application will be made at the 4th, 6th, and 8th hours after the surgery and the resulting pain and hoarseness will be evaluated."
15726999|NCT05048615|Drug|Venetoclax 100 MG|Patients will receive oral Venetoclax at a fixed dose of 100mg/day from day 1 to day 21 per cycle for a maximum of 2 cycles.
15726959|NCT05048862|Diagnostic Test|Muscle and nerve biopsy|Two muscle specimens with 5 x 5 x 5 mm were collected in an open muscle biopsy or needle biopsy at studied muscles under 2% lidocaine local anaesthesia. The wound was about 2-3 cm long, and suture was required. Would healing usually takes 10-14 days. First specimen was undergoing snap freezing fixation in a longitudinal axis perpendicular to the cork with the liquid nitrogen and isopentane. The second specimen was divided into two equiponderous tissues, and one was freezed in liquid nitrogen for DNA and protein analysis. The another one was treated with RNAlater solution in 4°C overnight for RNA analysis. Sural nerve biopsies or superficial peroneal nerve were obtained from a standard site posterior to the lateral malleolus under local anesthesia. The nerves were then fixed in 5% glutaraldehyde in 0.1 M phosphate buffer (PB) at 4 °C overnight. All samples were stored in the -80°C refrigerator for further analysis.
15726960|NCT05048862|Diagnostic Test|Genomics, transcriptome, and proteomics|The DNA, RNA, and protein of the tissues (blood, muscle, nerve and skin) were retrieved and stored in the -80°C refrigerator. The next generation sequencing (whole exon sequencing or whole genome sequencing) and RNA-seq would be performed by NGS & Microarray Core lab in National Taiwan University or another professional team. The protein analysis would be performed by the Proteomics & Protein Function Core Lab in National Taiwan University.
15726961|NCT05048862|Diagnostic Test|Laboratory of blood chemical substances, metals and endocrine profiles|The methods of the measurement will follow the standards set by Department of Laboratory Medicine of National Taiwan University Hospital.
15726962|NCT05048862|Diagnostic Test|Contact heat evoked potentials|A contact heat evoked potential stimulator (Medoc, Ramat Yishai, Israel) will be used for delivering heat stimulation. Stimuli will be delivered repeatedly to the same stimulation site and the inter-stimulus interval will be randomly set to around 18~22 s. CHEP will be recorded using a Nicolet Bravo evoked potential system (Nicolet Biomedical, Madison, WI). The recording electrode was placed at the Cz and P3 of international 10-20 system. The impendence of all recording electrodes was kept below 3 kΩ. The evoked potentials were filtered with a bandpass filter at 0.1~30 Hz. Recording was triggered by the onset of each stimulus, and the sweep time was 1500 ms.
15726963|NCT05048862|Diagnostic Test|Nerve excitability study|Nerve excitability studies will be undertaken on the median, tibial, peroneal and sural nerves as per previously detailed protocols. Skin temperature will be monitored at the site of stimulation and was maintained at >32°C. Stimulation and recording will be controlled by automated computerized system (QTRAC; Institute of Neurology, London, U.K.) and the stimulus current will be administered using an isolated linear bipolar constant-current stimulator (DS5; Digitimer, Welwyn Garden City, U.K.). Responses will be amplified (ICP511 AC amplifier, Grass Technologies, West Warwick, USA) with electronic noise removed (Hum Bug 50/60 Hz Noise Eliminator, Quest Scientific Instruments, North Vancouver, Canada).
15726964|NCT05048862|Diagnostic Test|Transcranial magnetic stimulation (TMS)|In simple rTMS protocols, individual stimuli are spaced apart by identical interstimulus intervals (ISI). The stimulation protocol was in accordance with published safety recommendations. The patterned rTMS protocols included (1) Theta burst stimulation, (2) Repetitive paired-pulse TMS. All the above stimulation protocols or paradigms will follow the international guideline of the use of TMS in clinical practice and research (Rossi et al., 2009; Fitzgerald and Daskalakis, 2012; Groppa et al., 2012; Steeves et al., 2012).
15726965|NCT05048862|Diagnostic Test|fMRI acquisition and image analysis|fMRI will be performed on a 3-T MR machine (Trio; Siemens, Erlangen, Germany). Each subject's head will be positioned comfortably inside a receive-only 8-channel birdcage head coil, supplied with ear plugs, heavily padded and secured with a strap across the forehead in order to minimize head motion. All data will be processed using SPM2 (Wellcome Department of Cognitive Neurology, London UK) 36 implemented on MATLAB (Mathworks Inc. Sherborn, MA).
15726966|NCT05048849|Biological|MVC-COV1901(S protein with adjuvant)|Approximately 500 participants will receive 2 doses of MVC-COV1901(S-2P protein with adjuvant) at Day 1 and Day 29 via intramuscular (IM) injection in the deltoid region
15726967|NCT05048836|Other|Food Subsidy, 6 months|Food subsidy for 6 months
15726968|NCT05048836|Other|Food Subsidy, 12 months|Food subsidy for 12 months
15726969|NCT05048836|Behavioral|Lifestyle Support, 6 months|lifestyle support intervention delivered by community health workers for 6 months
15726970|NCT05048836|Behavioral|Lifestyle Support, 12 months|lifestyle support intervention delivered by community health workers for 6 months
15726971|NCT05048836|Other|Food Delivery, 6 months|Twice monthly delivery of healthy food for 6 months
15726972|NCT05048836|Other|Food Delivery, 12 months|Twice monthly delivery of healthy food for 12 months
15726973|NCT05048823|Other|Visceral Osteopathic Techniques|Generalized Discharge Technique of the Peritoneum and Intestinal Wings, Mobilization of the Cecum, Technique for the Root of the Mesentery, Release of the D1-D2 Angle, Technique for the Sigmoid Colon
15726974|NCT05048823|Other|Simulated visceral techniques|Simulated visceral techniques in the region of the gastrointestinal system
15726975|NCT05048810|Radiation|68Ga-DOTA-NT-20.3|In this study, all patients will receive one injection of 68Ga-DOTA-NT-20.3, a PET radiopharmaceutical selective for neurotensin receptor 1 (NTR-1). For the injection, subjects will receive a target dose of 2-4 MBq per kg of body weight as a bolus injection. 68Ga-DOTA-NT-20.3 injection will be followed by a 10 ml saline flush.
15726976|NCT05048797|Drug|Trastuzumab Deruxtecan|Trastuzumab Deruxtecan administered by intravenous infusion
15726977|NCT05048797|Drug|Cisplatin|Investigator's choice of platinum chemotherapy (cisplatin) administered by intravenous infusion
15726978|NCT05048797|Drug|Carboplatin|Investigator's choice of platinum chemotherapy (carboplatin) administered by intravenous infusion
15726979|NCT05048797|Drug|Pembrolizumab|Pembrolizumab administered by intravenous infusion
15726980|NCT05048797|Drug|Pemetrexed|Pemetrexed administered by intravenous infusion
15726982|NCT05048771|Other|Questionnaire|Patients will be surveyed through self-administered questionnaires and semidirected interviews with a psychologist
15726983|NCT05048758|Other|No intervention|No intervention
15726984|NCT05048745|Procedure|interval appendectomy|interval appendectomy
15727000|NCT05048615|Drug|Itraconazole capsule|Patients will receive oral itraconazole at a dose of 100 mg every 12 hours from day 1 to day 21.
15727001|NCT05048615|Drug|Azacitidine Injection|Patients will receive a maximum of two cycles of daily subcutaneous Azacitidine at a dose of 75 mg/m2 (maximum 100 mg) from day 1 to day 7.
15727002|NCT05048589|Drug|Standard-Dose Quadrivalent Influenza Vaccine|For the control arm, the standard-dose quadrivalent influenza vaccines Influvactetra® and Vaxigriptetra will be used.
15727003|NCT05048589|Drug|High-Dose Quadrivalent Influenza Vaccine|For the control arm, the high-dose quadrivalent influenza vaccine Efluelda®/Fluzone® High-Dose Quadrivalent will be used.
15727004|NCT05048576|Behavioral|Negative Reinforcement|"Terms to be used in negative reinforcement:
~You've got to walk faster than that. You're so slow! Why do you walk like that? Did you learn how to walk yesterday? You're doing terrible. Who walks like that? You have potential but you don't use it. You'll never amount to anything. You're not putting very much effort into this. This is the worst pace you've had yet."
15727005|NCT05048576|Behavioral|Positive Reinforcement|"Terms to be used in positive reinforcement:
~Good job, you're doing awesome! Keep up the good work! You've got this! You're almost done, just a few more minutes! That's a great pace! You're going strong! Keep it up! Nice work. Great job! Good stuff. Keep it up. You're doing an amazing job."
15727006|NCT05048576|Behavioral|Silence|No recordings will be played during this condition.
15727007|NCT05048576|Behavioral|Music|Participant's can choose their own music to play during this condition.
15727008|NCT05048550|Device|Near vision spectacles|Near vision spectacles prescribed for full time wear (Add+3.00DS to the full cycloplegic refraction). These glasses will be changed to reflect changes in refractive error or frame fit as appropriate at follow up.
15727009|NCT05048537|Radiation|18F-FACBC PET/CT|10mCi 18F-FACBC IV injection, then whole body PET/CT after 4 mins
15727010|NCT05048524|Drug|S-1, leucovorin, oxaliplatin and gemcitabine|"Gemcitabine 800 mg/m2 on day 1, oxaliplatin 85 mg/m2 on day 1, S-1 orally 80-120 mg/day [depending on patient's body surface area (BSA)] on day 1 to 7 and leucovorin 30mg BID day 1 to 7 on in a 2-week cycle. The dose of S-1 is defined as follows:
~BSA < 1.25 m2: 80 mg/day
~1.25 m2 ≤ BSA < 1.5 m2: 100 mg/day
~BSA ≥ 1.5 m2: 120 mg/day"
15727011|NCT05048511|Biological|vitamin D estimation|Serum samples to estimate vitamin D status were collected on the sixth day of stimulation
15727012|NCT05048498|Drug|NEX-18a injection|"In Treatment phase 1, NEX-18a will be given as a single subcutaneous injection.
~In Treatment phase 2, NEX-18a will be given as a single subcutaneous injection."
15727013|NCT05048498|Drug|Azacitidine Injection|In Treatment phase 1, azacitidine will be administered once daily for four days. In Treatment phase 2, azacitidine will be administered once daily for three days.
15727014|NCT05048472|Diagnostic Test|Abbott HIV-1/2 VL Point of care Device|Point of care viral load monitoring
15727015|NCT05048459|Other|Standard surveillance|Participant coming to the clinic for in-person follow-up visits and having routine endoscopy and cancer imaging procedures as needed
15727016|NCT05048459|Other|Telemedicine surveillance (tele-surveillance)|The tele-surveillance visit occurs annually after completion of therapy and consists of a phone call with or without video conferencing between the patient and the treatment team (physician, nurse, and/ or nurse practitioner). The use of video conferencing is strongly encouraged. Clinic visits, endoscopies, and imaging studies can be performed at the discretion of the treatment team for concerning patient symptoms.
15727017|NCT05048459|Other|Questionnaires|EORTC QLQ-C30 and EORTC QLQ-HN43 at 12 and 24 months
15727019|NCT05048433|Behavioral|implementation strategy for active learning to promote physical activity|The experimental arm includes using a multifaceted implementation strategy to support the use of active learning approaches. The strategy will consist of a series of skills-based staff trainings, identifying program champions to help lead efforts within the school, establishing an audit and feedback system to monitor the use of active learning, and a reinforcement system to recognize staff who are successfully implementing.
15727020|NCT05048433|Behavioral|Usual Implementation support|Usual support consists of the potential to access general resources from the district wellness department. These resources include access to funds to send staff to external trainings and general guidance for how to use active learning approaches.
15727021|NCT05048420|Procedure|surgery|ACL reconstruction and RAMP lesion repair
15727022|NCT05048407|Device|Gynaecological laparoscopic surgery (Sirius System)|"The laparoscopic procedures were done in the usual manner. The only difference was for the study participants, the Sirius System was used in place of the usual conventional laparoscope. All other procedures and instruments including the number of ports remained the same.
~For every procedure using the Sirius System, a conventional laparoscope was on immediate standby to replace the Sirius System should there be an unanticipated equipment failure so that the procedure could be completed without delay."
15727023|NCT05048394|Device|Semi-autonomous myoelectric control algorithm|The semi-autonomous myoelectric control algorithm will be implemented on a by-pass prosthetic socket with a sensorized TASKA prosthetic hand.
15727024|NCT05048394|Device|Standard-of-care myoelectric control algorithm|The standard of care myoelectric control algorithm will be implemented on a by-pass prosthetic socket with a sensorized TASKA prosthetic hand.
15727025|NCT05048381|Diagnostic Test|Next Generation Sequencing|Next Generation Sequencing of sweat and whole blood samples for non-coding miRNAs to define biomarkers that enable to differentiate between patients with active tuberculosis, a differential diagnostic disease and healthy individuals.
15727026|NCT05048368|Drug|Larotinib|Capsules, Oral, 350 mg, single dose, one day
15727027|NCT05048355|Device|Power Knee Mainstream Dynamic|Powered Microprocessor controlled prosthetic knee. The Power Knee Mainstream - Dynamic, was designed to provide powered swing dynamics to restore muscle activity and thereby attempting to mitigate this increase in metabolic cost that individuals living with TF amputation face.
15727028|NCT05048355|Device|Passive microprocessor controlled knee|Any passive microprocessor controlled prosthetic knee on the market
15727029|NCT05048342|Drug|LOU064|Arm 1: LOU064 (open label)
15727030|NCT05048329|Other|Non-invasive continuous remote monitoring with structured escalation pathway|Continuous patient monitoring through non-invasive biosensors coupled with machine learning algorithms, with a structured escalation and communication pathway for home health providers and colorectal clinical team
15727031|NCT05048329|Other|Affective Analysis of Participant Response to Continuous Remote Patient Monitoring|Surveys and interviews with enrolled participants
15727032|NCT05048316|Behavioral|Cognitive-Behavioral Stress Management and Health Education|Participants will attend group sessions with a trained facilitator held over videoconference. Sessions will each last 2 hours and will be held once weekly for 10 weeks. Sessions will include Cognitive-Behavioral Stress Management and health education content.
15727033|NCT05048303|Procedure|Arthroscopic modified individualized flexible Latarjet procedure|The modifications were as follows: (1)the coracoid graft and conjoint tendon were prepared using a mini-open technique with an incision of 2.5 cm and coracoacromial ligament were preserved. A total of 2 bone tunnels were drilled. (2)The anterior (including part of the incision used for obtaining the graft), standard antelateral, and posterior portals were set. (3) The glenoid was marked at the 4-o'clock position, and then the subscapularis muscle was split. (4)The glenoid tunnel was drilled where the suture linked to the graft was passed, and the graft was pulled to the glenohumeral joint via the sutures. A knotless suture anchor for antirotation (PushLock; Arthrex) was fixed to the glenoid to prevent rotation of the graft.
15727034|NCT05048290|Other|Communication Skills Training|Participate in communication workshops
15727035|NCT05048290|Other|Communication Skills Training|Participate in generic communication skills workshops
15727036|NCT05048290|Other|Educational Intervention|Develop a video
15727037|NCT05048290|Other|Survey Administration|Complete surveys
15727038|NCT05048277|Behavioral|Single Session Consultation|"Single-Session Consultation (SSC) is a low-intensity, goal-directed, solution-focused counseling service used for treatment of mental health problems. The intervention consists of a 60-minute session conducted through NYU ZOOM, a HIPAA compliant teleconferencing platform. Sessions will be conducted between a parent and a study consultant. The consultant will 1) identify the participant's specific modifiable goal (and associated hope); 2) the smallest-possible step taken to overcome their problem; and 3) work collaboratively in creating an Action Plan, drawing on their inner abilities and external resources. This intervention does not act as therapy but instead, to potentially jumpstart progress and facilitate hope and agency. Following completion, participants will receive their Action Plan. Additional personalized resources will be provided following completion of the follow-up assessment, which includes referrals for further services and online resources."
15727039|NCT05048264|Drug|Kenalog 40 MG|40 MG/ML Injectable Suspension
15727040|NCT05048264|Drug|Dexamethasone 4mg|4 Mg/mL Injectable Solution
15727041|NCT05048264|Drug|Celestone|6 MG/ML Injectable Suspension
15727042|NCT05048264|Drug|Depo-medrol|40 MG/ML Injectable Suspension
15727043|NCT05048251|Device|cTBS|continuous theta burst stimulation
15727044|NCT05048251|Device|iTBS|intermittent theta burst stimulation
15727045|NCT05048251|Device|sham|sham stimulation
15727046|NCT05048238|Drug|tofacitinib XR|Tofacitinib comes as an extended-release (XR) (long-acting) tablet to take by mouth. The extended-release tablet is usually taken with or without food once daily.
15727047|NCT05048238|Procedure|ultraviolet light B (UVB) phototesting|UV lamp. Phototesting will occur at the University of Michigan Department of Dermatology on Days 0 (Visit 1, prior to initiation of tofacitinib XR treatment) and Day 25 (Visit 4, upon completion of tofacitinib XR treatment).
15727048|NCT05048238|Procedure|skin biopsy|6mm-diameter punch biopsies of nonlesional skin on: Day 1 (Visit 2, prior to initiation of tofacitinib XR treatment) and Day 26 (Visit 5, upon completion of tofacitinib XR treatment).
15727052|NCT05048199|Device|pressure regulated volume-controlled mode of ventilation|"Cardiac output non-invasive monitor for measuring SV. Hemodynamic variables including heart rate (HR), mean arterial blood pressure (MAP), central venous pressure (CVP), stroke volume (SV), stroke volume index (SVI), cardiac output (COP), cardiac index (CI), systemic vascular resistance (SVR), systemic vascular resistance index (SVRI), thoracic fluid content (TFC), corrected flow time (FTC), index of contractility (ICON), and systolic time ratio (STR), Arterial oxygen saturation (Sao2), oxygen delivery (DO2) and oxygen delivery index (DO2I) will be recorded.
~These variables will be obtained before induction of anaesthesia (T1) skin incision (T2), then every 30 min till the resection of the urinary bladder (T3a, T3b, T3c, …. etc). The mode of ventilation will swift to the other mode 5 minutes after cystectomy (T4), then every 30 min till end of the urinary diversion (T5a, T5b, T5c, …. etc), end of surgery (T6), and postoperative every 4h for 24 hours( P1-P6)."
15727053|NCT05048199|Device|volume-controlled mode of ventilation|"Cardiac output non-invasive monitor will be used for measuring SV. Hemodynamic variables including heart rate (HR), mean arterial blood pressure (MAP), central venous pressure (CVP), stroke volume (SV), stroke volume index (SVI), cardiac output (COP), cardiac index (CI), systemic vascular resistance (SVR), systemic vascular resistance index (SVRI), thoracic fluid content (TFC), corrected flow time (FTC), index of contractility (ICON), and systolic time ratio (STR), Arterial oxygen saturation (Sao2), oxygen delivery (DO2) and oxygen delivery index (DO2I) will be recorded.
~These variables will be obtained before induction of anaesthesia (T1) skin incision (T2), then every 30 min till the resection of the urinary bladder (T3a, T3b, T3c, …. etc). The mode of ventilation will swift to the other mode 5 minutes after cystectomy (T4), then every 30 min till end of the urinary diversion (T5a, T5b, T5c, …. etc), end of surgery (T6), and postoperative every 4 hours for 24 hours (P1-P6)."
15727054|NCT05048186|Behavioral|Attention Deficit Hyperactivity Disorder Treatment Decision Aid|The parent pre-visit cards from the Cincinnati Children's Hospital's Attention Deficit Hyperactivity Disorder (ADHD) Treatment for School Age Children Decision Aid were used in this study. The 6 pre-visit cards provide an overview of ADHD treatment options, the respective benefits and downsides of each option, and questions to elicit goals/preferences. The four different treatment options presented were: (1) watchful waiting, (2) behavioral treatment, (3) medication treatment, and (4) combined treatment (behavioral and medication together).
15727055|NCT05048173|Procedure|Sentinel lymph node mapping and biopsy|Sentinel lymph node mapping with indocyanine green dye followed by biopsy if positive
15727056|NCT05048173|Procedure|Lymphadenectomy|Conventional lymphadenectomy
15727057|NCT05048160|Drug|Intravenous Infusion|Dose-limiting toxicity (DLT) are assessed during the first 3 weeks (21 days) after initial administration. Then, the intended dosing frequency is every 2 weeks (Q2W).
15727094|NCT05047913|Drug|18F-FTX|Given By IV
15727058|NCT05048147|Behavioral|Community Mobilization|The Community Mobilization (CM) strategy will include: (1) Community advisory board [comprising local community-based organizations, government officials, and residents], that will provide leadership support and buy-in for adoption of Clean Fuel- Clean- Stove (CF-CS) use; (2) Trained MoH community health extension workers (CHEWs), who will form community action teams (CAT) to facilitate the implementation of CF-CS use via provision of support, knowledge exchange and performance feedback to the primary cooks in participating households; (3) Community dialogues with residents and households focused on shared concerns on the significance and importance of CF-CS use.
15727059|NCT05048134|Drug|HRS2300|HRS2300 monotherapy
15727060|NCT05048134|Drug|HRS2300、 SHR-1316|HRS2300 combined with SHR-1316
15727061|NCT05048134|Drug|HRS2300、SHR-1701|HRS2300 combined with SHR-1701
15727062|NCT05048134|Drug|HRS2300、trametinib|HRS2300 combined with trametinib
15727063|NCT05048134|Drug|HRS2300、Almonertinib|HRS2300 combined with Almonertinib
15727064|NCT05048121|Other|Cosmetic Active Ingredient CLS02021|Topical, face application of the cream base with the CLS02021, two times a day in a period of 30 days
15727065|NCT05048121|Other|Placebo PLC01021|Topical, face application of the cream base, two times a day in a period of 30 days
15727067|NCT05048082|Drug|pegsitacianine|An intraoperative nanoparticle-based fluorescence imaging agent comprised of micelles covalently conjugated to indocyanine green (ICG).
15727069|NCT05048056|Drug|Placebo|Placebo subcutaneous injection every 2 weeks for 16 weeks then Crossover to AK120 Regimen 1
15727070|NCT05048056|Drug|AK120|AK120 Regimen 1- subcutaneous injection every 2 weeks.
15727071|NCT05048056|Drug|AK120|AK120 Regimen 2- subcutaneous injection every 2 weeks
15727072|NCT05048043|Behavioral|Computer-assisted Behavior Intervention|"The CABI includes a serious game called ATHEMOS that is designed to help students rehearse skills that ameliorate impairments associated with ADHD, including organization, scheduling, and note taking strategies. Once students have some experience with the game, a teacher consultee will help students actively transfer skills learned in the game to real-world classroom demands."
15727073|NCT05048043|Behavioral|Challenging Horizons Program|The Challenging Horizons Program is an established psychosocial intervention package for young adolescents with ADHD, focusing on academic and behavioral impairments.
15727074|NCT05048017|Drug|Regorafenib|Regorafenib, 120 mg, once a day, 3 weeks on/1 week off
15727075|NCT05048017|Drug|PD-1 inhibitor|"Camrelizumab: 200mg (BW ≥ 50 kg) or 3 mg/kg (BW < 50 kg) Toripalimab: 240mg is given through intravenous drip every 3 weeks on Day 1 of each course of treatment.
~Pembrolizumab: 200mg is given through intravenous drip every 3 weeks."
15727076|NCT05048004|Procedure|Pulmonary Vein Isolation|Patients undergoing different forms of pulmonary vein isolation are being monitored for microembolic signals (MES) by transcranial ultrasound. For standard ablation, a Thermocool Smarttouch SF (Biosense Webster) catheter will be used (50 W, target ablation index of 550). For comparison, 35 W on the anterior and 20 W on the posterior left atrium will be used. Furthermore, different periprocedural regimes of oral anticoagulation (continuous vs. minimally interrupted) will be compared.
15727077|NCT05047991|Drug|Irinotecan Liposome Injection|Irinotecan Liposome Injection, intravenously, over 90 min on day 1and day 15 of every 28-day cycle
15727078|NCT05047991|Drug|Fluorouracil|5-Fluorouracil (5-Fu), intravenously, over 46 h on day 1 and day 15 of every 28-day cycle
15727079|NCT05047991|Drug|Leucovorin|Leucovorin (LV), intravenously, over 30 min on day 1 and day 15 of every 28-day cycle
15727080|NCT05047991|Drug|Oxaliplatin|Oxaliplatin, intravenously, over 2 h on day 1 and day 15 of every 28-day cycle
15727081|NCT05047991|Drug|Nab paclitaxel|Paclitaxel (albumin bound), intravenously, over 30 min on day 1, day 8 and day 15 of every 28-day cycle
15727082|NCT05047991|Drug|Gemcitabine|Gemcitabine, intravenously, over 30 min on day 1, day 8 and day 15 of every 28-day cycle
15727083|NCT05047978|Other|Cow's milk protein infant formula|A routine cow's milk-based infant formula
15727084|NCT05047978|Other|Partially hydrolyzed protein infant formula|A partially hydrolyzed cow's milk protein (PHP) infant formula
15727085|NCT05047965|Procedure|Dixon MRI|Undergo Dixon MRI
15727086|NCT05047965|Procedure|Magnetic Resonance Imaging|Undergo standard MRI
15727087|NCT05047952|Drug|Vortioxetine|Participants receiving vortioxetine will be provided 10 mg/day on days 1-14 of the treatment period, and will be titrated to 20 mg/day at the start of week 3 (day 15) based on study clinician judgment. For the remaining 6 weeks, the dose of vortioxetine will be 20 mg/day, unless adjudicated otherwise by a study clinician.
15727088|NCT05047952|Drug|Placebo|A placebo pill will be taken once daily.
15727089|NCT05047939|Drug|remimazolam-based TIVA|In the remimazolam-based TIVA group, general anesthesia is induced and maintained with a continuous infusion of remimazolam using an infusion pump. In the remimazolam group, its antagonist, flumazenil, is administered at the end of surgery.
15727090|NCT05047939|Drug|propofol-based TIVA|In the propofol-based TIVA group, general anesthesia is induced and maintained with a target-controlled infusion of propofol using an infusion pump (Orchestra®; Fresenius Vial, France).
15727091|NCT05047926|Behavioral|Exercise - Physical Activity|The recommended exercise program will consist walking for 30 mins per day, 3 days per week, at any pace in any environment. In addition the subjects will be given resistance bands and instruction on following the REST program, a home-based upper and lower body strength program that uses resistance bands to improve strength and balance.
15727092|NCT05047926|Behavioral|Resiliency Training|The Resilient Living program is modified from the Stress Management and Resiliency Training (SMART) program; which has been shown to be effective in improving resiliency, perceived stress, anxiety, and overall quality of life in a variety of populations.
15727093|NCT05047926|Dietary Supplement|Protein Supplementation|Increased protein intake is recommended for persons with advance cancer due to malnutrition and low albumin levels. Protein intake recommendations are 1.2 -1.5 g/kg/day. A daily protein recommendation will be calculated at the time of enrollment and subjects will be allowed to select their preferred protein supplement.
15727096|NCT05047887|Procedure|Modified socket shield technique with autogenous dentin graft material|The crown of the hopeless tooth will be decoronated, the root will then be sectioned, the lingual root fragment will be carefully retrieved, the remaining buccal root fragment will be thinned and concaved, The coronal part of this shield will be beveled to make a lingual slope then Tooth particles will be demineralized using 2% HNO3 (El-Gomhouria CO. Egypt) for 20 minutes to expose the dentin organic matrix.
15727097|NCT05047887|Procedure|Modified socket shield technique with alloplast graft material|The crown of the hopeless tooth will be decoronated, the root will then be sectioned, the lingual root fragment will be carefully retrieved, the remaining buccal root fragment will be thinned and concaved, The coronal part of this shield will be beveled to make a lingual slope then alloplast graft will be used
15727098|NCT05047874|Behavioral|systemic methylprednisolone|short-term (3 days) high-dose (1000 mg) systemic methylprednisolone and low-dose long-term (2x 40 mg) systemic methylprednisolone
15727099|NCT05047861|Procedure|socket shield technique with autogenous dentin graft|"The crown of the hopeless tooth will be decoronated with a chamfer diamond bur and a large-head round diamond bur under copious irrigation, until the bone crest level.
~The root will then be sectioned along the long axis into buccal and palatal halves with a long shank fissure bur.
~The lingual root fragment will be carefully retrieved using microperiotome. The remaining buccal root fragment will be thinned and concaved slightly with a long shank fissure bur. The thickness of the buccal root fragment should be at least 1.5 mm to ensure resistance to fracture and resorption.
~The coronal part of this shield will be beveled to make a lingual slope for a better emergence profile with a large head round diamond bur.
~The socket shield will be checked for immobility so the implant could be inserted palatally into the socket shield.
~After the final preparation of the socket shield, Graft will be placed using autogenous dentin graft from the discarded palatal part of the tooth"
15727100|NCT05047861|Procedure|socket shield technique with alloplast graft|"The crown of the hopeless tooth will be decoronated with a chamfer diamond bur and a large-head round diamond bur under copious irrigation, until the bone crest level.
~The root will then be sectioned along the long axis into buccal and palatal halves with a long shank fissure bur.
~The lingual root fragment will be carefully retrieved using microperiotome. The remaining buccal root fragment will be thinned and concaved slightly with a long shank fissure bur. The thickness of the buccal root fragment should be at least 1.5 mm to ensure resistance to fracture and resorption.
~The coronal part of this shield will be beveled to make a lingual slope for a better emergence profile with a large head round diamond bur.
~The socket shield will be checked for immobility so the implant could be inserted palatally into the socket shield.
~After final preparation of socket shield, Graft will be placed Alloplast graft"
15727101|NCT05047848|Drug|Chidamide|chidamide 30mg orally，Biw
15727102|NCT05047848|Drug|Fulvestrant|Fulvestrant 500mg i.m. injections every 28 days (Cycle n Day 1) with 1 additional dose on Day 15 of Cycle 1
15727103|NCT05047835|Diagnostic Test|electrocardiogram|Prone position electrocardiogram
15727104|NCT05047809|Other|"Jingchuang Ointment(JCO)"|Applied once a day on the wounds
15727105|NCT05047809|Other|Regular Treatment|"Do not use the Jingchuang Ointment(JCO), as the regular treatment as usual."
15727106|NCT05047796|Other|Intervention Protocol|The intervention protocol will consist of visceral osteopathic techniques and will be performed by a professional who has 17 years of clinical experience in the field of Osteopathy.
15727107|NCT05047796|Other|Sham Protocol|The sham protocol will be performed by a professional who has 17 years of clinical experience in the field of Osteopathy. The sham protocol will consist of simulation of therapy, where the therapist will place his hands in the same regions of the intervention protocol, without therapeutic intent
15727108|NCT05047783|Drug|Masitinib Mesylate|3CL-protease inhibitor
15727109|NCT05047783|Drug|Placebo|Placebo
15727113|NCT05047757|Dietary Supplement|Test meal with 15N labeled favabean|Ingestion of a 15N labeled test meal. Subjects are equipped with a nasoileal tube. 15N is followed in biological fluids (plasma, effluents, urines).
15727114|NCT05047744|Device|Touch Dual Mobility CMC I Prosthesis|Surgery
15727116|NCT05047718|Biological|COVID-19 vaccine Pfizer (2 doses)|A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring
15727117|NCT05047718|Biological|COVID-19 vaccine Pfizer (1 dose)|A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring
15727118|NCT05047718|Biological|COVID-19 mRNA Vaccine Moderna (2 doses)|A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring
15727119|NCT05047718|Biological|COVID-19 mRNA Vaccine Moderna (1 dose)|A longitudinal analysis of the immune response post COVID-19 vaccine will be performed with a close immunomonitoring
15727121|NCT05047692|Biological|AdCLD-CoV19-1|Replication deficient adenoviral vector based COVID-19 prevention vaccine containing recombinant gene of SARS-CoV-2 spike protein
15727151|NCT05047367|Behavioral|cross-sectional survey study|Beck Depression Scale, Beck Anxiety Scale for psychological evaluation, Visual Analogue Scale and PainDETECT Questionnaire for pain, Pittsburgh Sleep Quality Scale and Epworth Sleepiness Scale for sleep quality
15727152|NCT05047341|Drug|SHR0302、[14C]SHR0302|8 mg SHR0302/ 80 µCi [14C]SHR0302, once, D1
15727387|NCT05045352|Device|echogenic needles for intravenous access|echogenic needles for intravenous access (subclavian vein) ultrasound guided procedure
15727122|NCT05047679|Behavioral|Perioperative Pain Neuroscience Education|Perioperative pain neuroscience education addresses modifiable preoperative risk factors, and in particular cognitive and emotional risk factors, such as fear of movement and pain catastrophizing (i.e., excessively negative orientation toward pain). This education is a cognitive-based therapeutic intervention which reconceptualizes pain, informs patients about what to expect from the evolution of their pain, de-emphasizes the patho-anatomical content and focuses on factors contributing to the development of pain. It explains this all within a biopsychosocial framework, which means that it aims to optimize patients' beliefs. Furthermore, it intends to reassure the patient about the decision to have surgery, to potentially decrease perioperative distress.
15727123|NCT05047679|Behavioral|Perioperative Biomedical Education|Perioperative biomedical education will discuss the anatomy, physiology and biomechanics of the lumbar spine with the patient. Additionally, the content of this education includes the expected course of postoperative back and leg pain, as well as ergonomic advice on patient-specific daily activities. This education will be given within a biomedical framework, which means that it aims to explain the patients' complaints and recovery while focusing on anatomy and biomechanics, as opposed to patients' beliefs and cognitions.
15727124|NCT05047653|Diagnostic Test|RALE score vs. severity score|RALE score vs. severity score and CORADS
15727125|NCT05047640|Biological|BNT162b2 vaccine|Single dose of 0.3 mL BNT162b2 vaccine administered intramuscularly in the deltoid muscle
15727126|NCT05047640|Biological|JNJ-78436735 Vaccine|Single dose JNJ-78436735 Vaccine administered intramuscularly in the deltoid muscle
15727127|NCT05047627|Behavioral|Smartphone-Based Digital Intervention|The digital intervention will be a prototype, and the current trial will be used to continue to both develop and refine the intervention. The current intervention will be based on a combination of cognitive-behavioral principles. As with prior research, the mobile platform will be delivered via Qualtrics, a HIPAA compliant and mobile-friendly platform. The cognitive-behavioral therapy will be primarily based on components with strongest support in digital interventions. The app will continuously collect passive sensing data on patterns in 1) sleep duration and quality;(2) light (3) location; (4) movement (5) social contact including duration and frequency of incoming and outcoming calls and text messages; (6) screen time; and (7) heart rate variability; (8) sound levels captured through passively collected smartphone The platform will deliver interactive interventions where participants will view texts and images, and it will also allow user interaction.
15727128|NCT05047614|Device|including sham|Repositiong feedback training and biofeedback pressure training unit
15727133|NCT05047575|Other|REASSURE|6 months following enrollment, survivors enrolled in REASSURE will take a patient-reported outcomes (PRO) assessment. PRO survey will be scored and a referral recommendation will be determined. Survivors' medical oncologist will make their own referral assessment and will take precedent during this pilot study. Primary care providers will be notified of survivor participation at the time of enrollment.
15727134|NCT05047562|Other|Pilates Group|16 Pilates exercise sessions twice a week for 2 months.
15727135|NCT05047562|Other|Segmental Stabilization group|16 sessions of segmental stabilization exercises, 2 times a week for 2 months.
15727136|NCT05047536|Drug|KZR-261|KZR-261 for Injection is a lyophilized drug product supplied in single-use vials delivering 75 mg of KZR-261.
15727137|NCT05047523|Drug|ALXN1840|Administered as an oral tablet.
15727138|NCT05047523|Drug|Standard of Care|Depending on the site/region, participants randomized to receive Standard of Care treatment will receive trientine, penicillamine, zinc, or a combination of these medicines, administered according to standard regimens.
15727139|NCT05047510|Drug|Anti-GPC3-IRDye800CW|Drug Injection: Anti-GPC3-IRDye800CW
15727140|NCT05047497|Diagnostic Test|questionaire and ventilatory function test|we assessed the arterial blood gases and the ventilatory functions and quality of life of whole three groups
15727141|NCT05047484|Drug|ALXN2050|Powder-in-capsule (PIC).
15727142|NCT05047484|Drug|Placebo|PIC.
15727143|NCT05047458|Drug|ALXN2050|Powder-in-capsule (PIC).
15727144|NCT05047458|Drug|Placebo|PIC.
15727145|NCT05047445|Biological|COVIDITY administered via needle-free injection (PharmaJet Tropis®; intradermal injection).|COVIDITY (intradermal) consists of two 0.2 mg doses of the plasmid DNA vaccine SCOV1 (administered on Day 1 and Day 29), followed by two 0.2 mg doses of the plasmid DNA vaccine SCOV2 (not before Days 113 and 141 [doses 4 weeks apart]).
15727146|NCT05047445|Biological|COVIDITY administered via needle-free injection (PharmaJet Stratis®; intramuscular injection).|COVIDITY (intramuscular) consists of two 1.0 mg doses of the plasmid DNA vaccine SCOV1 (administered on Day 1 and Day 29), followed by two 1.0 mg doses of the plasmid DNA vaccine SCOV2 (not before Days 113 and 141 [doses 4 weeks apart]).
15727147|NCT05047432|Other|Non-interventional trial|Non-interventional trial
15727148|NCT05047406|Dietary Supplement|Bacillus clausii Probiotic liquid|mini bottles for oral administration containing 2 million spores of Bacillus clausii
15727149|NCT05047393|Other|Current blood vitamin D level and painDetect questionairre score will be detected|PainDETECT neuropathic pain questionnaire will be used to evaluate the presence of nociceptive, mixed and neuropathic pain in patients. Patients with a total questionnaire score of 12 or less are considered nociceptive pain without a neuropathic pain component. If the total score is in the range of 13-18, the result is uncertain, but it is accepted that the neuropathic component can be found in the mixed type, and in the scores of 19 and above, it is accepted that the neuropathic pain component is present. Patients with previously obtained and finalized vitamin D levels < 20 ng/mL, 20-30 ng/mL, and ˃30 ng/mL will be grouped as deficiency, insufficiency and normal, respectively.
15727150|NCT05047380|Behavioral|Owstery Disability Scale for disability Beck Depression Scale, Beck Anxiety Scale for psychological evaluation, VAS for pain, Pittsburgh Sleep Quality Scale for sleep quality|All assessments will be made using questionairres. The Oswestry Disability Index scale will be filled in to assess the severity of disability resulting from pain in the patient. Pain severity will be evaluated with the Visual Analog Scale (VAS). Depression and anxiety assessment will be made with Beck Depression Scale and Beck Anxiety Scale, respectively. Sleep quality will be evaluated with the Pittsburg Sleep Quality Index.
15727183|NCT05047146|Other|Morphological classifications of HCC|Morphological classifications of Hepatocellular carcinoma
15727153|NCT05047328|Biological|inolimomab|"1 or 2 Induction Phases at 0.3 mg/kg/day for adults or 0.4 mg/kd/day for children over 8 consecutive days If no complete response (CR) occurs after 8 days, a second induction phase is conducted until day 16 (even if CR is obtained before completion of the second induction phase).
~Maintenance Phase: 0.4 mg/kg administered 3 times a week until Day 28 In case of a CR at day 9, the maintenance phase will start after day 9 and will be sustained until day 28.
~In case of a CR, partial response (PR) or mixed response (MR) at day 17, the maintenance phase will start after day 17 and will be sustained until day 28.
~Total duration of treatment is 28 ±2 days."
15727154|NCT05047302|Device|BlueLeaf Procedure|The device is intended to form autogenous tissue leaflets from vein walls without the use of a permanent vascular implant.
15727155|NCT05047276|Biological|AloCelyvir|Delivery of Icovir-5 by mesenchymal carrier cells in uveal melanoma patients with hepatic metastases.
15727156|NCT05047263|Drug|Finerenone (BAY94-8862)|Tablet, 10 mg or 20 mg, once daily (OD), oral
15727157|NCT05047263|Drug|Placebo|Tablet, once daily, oral
15727164|NCT05047237|Behavioral|Pharmacist-Led Optimization Intervention|Educational information mailed to participants and up to three pharmacist visits.
15727165|NCT05047224|Behavioral|Tele-assessment + in-person assessment|Participants will complete a tele-assessment using the TAP. They will complete a traditional, in-person autism spectrum disorder assessment approximately two weeks later.
15727166|NCT05047224|Behavioral|Tele-assessment only|Participants will complete a tele-assessment using the TAP. They will complete a second, shorter tele-assessment approximately two weeks later.
15727167|NCT05047211|Drug|Ferrous sulfate|one tablet 325 milligrams three times a day
15727168|NCT05047211|Drug|Iron dextran|1000 mg intravenous infusion
15727169|NCT05047198|Procedure|Control - Catheter Ablation for VT|"Currently standard of care involves surgical resection of myocardial scarring in structural heart disease. Imaging is performed to identify culprit areas for ablation, pre procedural imaging involves echocardiography, CT scanning and PET imaging to assess cardiac function, ischemia, inflammation and scarring. Radiofrequency energy is delivered via catheter to the targets and is performed under sedation or anesthesia using multiple catheters placed in the heart while the patient is anticoagulated. A conventional approach will be used advancing multiple catheters via femoral veins and/or arteries under a combination of fluoroscopic, ultrasound and electroanatomic guidance. Ablation targets include an arrhythmogenic focus or the critical isthmus of the VT circuit and/ or substrate identified on preprocedural imaging or low voltage areas, scar, identified during endocardial mapping. CA procedures for VT are often long, averaging approximately 5 hours ."
15727170|NCT05047198|Procedure|Treatment - Non-Invasive Radio Ablation for VT|Patients undergoing a non-invasive RA procedure for VT similarly require medical stabilization and multimodal imaging prior to treatment. A non-invasive electrophysiology study is performed under light sedation using ECGi mapping. This procedure requires only the placement of an IV cannula for light sedation, uses the ICD to stimulate VT which is mapped in real time using the ECGi mapping system. The multimodal imaging data is digitally fused and combined with the ECGi data to identify the VT circuit(s) and to attain the targets for radio-ablation. This analogue process is performed off-line by a physician team. The treatment plan is sent for alignment on a 4D planning CT performed with breath holding in the radiotherapy suite. Final treatment targets are reviewed by the local treating team and discussed with our collaborators remotely. Thereafter the patient is booked for a 15 minute out-patient radiotherapy treatment performed on a standard linear accelerator.
15727171|NCT05047185|Drug|PHA-022121|PHA-022121 softgel capsules for oral use (PHVS416)
15727172|NCT05047185|Drug|PHA-022121|PHA-022121 PHA-022121 softgel capsules for oral use (PHVS416)
15727173|NCT05047185|Drug|Placebo|Matching placebo capsules for oral use
15727174|NCT05047172|Drug|Ticagrelor + Aspirin|ticagrelor (180 mg loading dose, then 90mg twice daily) and aspirin (81mg daily)
15727175|NCT05047172|Drug|Rivaroxaban + Aspirin|low dose rivaroxaban (2.5mg twice daily) and aspirin (81mg daily)
15727176|NCT05047172|Drug|Clopidogrel + Aspirin|clopidogrel (600mg loading dose, then 75mg daily) and aspirin (81mg daily)
15727177|NCT05047172|Other|Risk Factor Management|Risk factors for stroke (LDL, blood pressure, non-HDL cholesterol, diabetes, smoking, weight, and physical activity) will be monitored and managed.
15727178|NCT05047159|Device|rTMS|"Stimulation will be performed for 20 working days once a day (4 weeks). Extend course to 30 sessions (6 weeks) in responders who have not achieved symptom remission.
~Frequency: 10Hz; Intensity: 110% RMT; Coil-type: F8; Sessions-pulse: 3000; Site: the left dorsolateral prefrontal cortex."
15727179|NCT05047159|Device|light therapy|Active 10,000-lux fluorescent white light box for 30 min/d in the early morning for 6 weeks.
15727180|NCT05047159|Device|ECT|The electrode placements are bifrontal (BF); the electrical intensity is 1.5 to 2.0 times the seizure threshold (ST); 3 times per week.
15727181|NCT05047159|Device|MST|A coil placement at the vertex (i.e., Cz in 10-20 electroencephalogram [EEG] system) with a frequency of stimulation of 100 Hz, pulse width of 0.2 to 0.4 ms, and stimulation duration of 10 seconds; 2 times per week.
15727182|NCT05047159|Drug|drug therapy|There is no restriction on the choice of therapeutic drugs.
15728132|NCT05039177|Drug|Cetuximab|Administered via intravenous infusion
15727184|NCT05047133|Drug|Tranexamic acid|TXA to be given at time of diagnosis in the emergency department (ED) in treatment group and at time of operation for both groups
15727185|NCT05047120|Behavioral|Hypnosis Enhanced Cognitive Therapy|in-person hypnosis enhanced cognitive therapy for pain management following SCI
15727186|NCT05047107|Other|No intervention|Non-interventional study
15727189|NCT05047081|Behavioral|Scoring Your College Goals Workshop|A two-hour virtual college readiness workshop.
15727190|NCT05047081|Other|Placebo|Placebo Treatment-As-Usual Group which does not receive the workshop intervention
15727191|NCT05047068|Device|OCS Heart|Multi-center, observational post-approval registry to compare patient and graft survival of adult primary heart transplant recipients receiving DBD donor hearts perfused and assessed on the OCS Heart System compared to adult recipients of DBD donor hearts preserved using ischemic cold storage hearts (Control) at the same Registry centers over the same time period.
15727192|NCT05047055|Drug|Isoniazid|Intensive Phase for 2 months and Continuation phase for 2 months dose: 75 mg (2 tablets for 30 - 34 Kg, 3 tablets for 35 - 49 Kg, 4 tablets for 50 - 64 Kg, 5 tablets for 65 - 75 Kg and 6 tablets for >75 Kg) as a fixed-dose combination.
15727193|NCT05047055|Drug|Rifampicin|Intensive Phase for 2 months and Continuation phase for 2 months dose: 150 mg (2 tablets for 30 - 34 Kg, 3 tablets for 35 - 49 Kg, 4 tablets for 50 - 64 Kg, 5 tablets for 65 - 75 Kg and 6 tablets for >75 Kg) as a fixed-dose combination.
15727194|NCT05047055|Drug|Pyrazinamide|Intensive Phase for 2 months only dose: 400 mg (2 tablets for 30 - 34 Kg, 3 tablets for 35 - 49 Kg, 4 tablets for 50 - 64 Kg, 5 tablets for 65 - 75 Kg and 6 tablets for >75 Kg) as a fixed-dose combination.
15727195|NCT05047055|Drug|Ethambutol|Intensive Phase for 2 months and Continuation phase for 2 months dose: 275 mg (2 tablets for 30 - 34 Kg, 3 tablets for 35 - 49 Kg, 4 tablets for 50 - 64 Kg, 5 tablets for 65 - 75 Kg and 6 tablets for >75 Kg) as a fixed-dose combination.
15727196|NCT05047055|Drug|Moxifloxacin|Intensive Phase for 2 months and Continuation phase for 2 months dose: 400 mg for 30 to 64 yrs AND 600 mg for 65 and above years of age.
15727197|NCT05047042|Behavioral|Advanced Cancer Support in Virtual Rehabilitation and Exercise|The study intervention will consist of an individualized 8-week program of online exercise modules, supervised interactive group class and one-to-one consultations with an exercise or rehabilitation specialist and a pain and symptom physician, delivered via secure live Zoom sessions.
15727198|NCT05047029|Procedure|Transjugular intrahepatic portosystemic shunt implantation|Transjugular intrahepatic portosystemic shunt is an artificial channel within the liver that establishes communication between the inflow portal vein and the outflow hepatic vein. It is used to treat portal hypertension (e.g., in liver cirrhosis)
15727199|NCT05047029|Diagnostic Test|Magnetic resonance imaging|Multiparametric cardiac and hepatic magnetic resonance imaging
15727200|NCT05047016|Other|Virtual investigational product|The virtual investigational product is a predefined text (e.g. AB123F). By entering the code into the application, the virtual 'administration' of the IP is conducted.
15727201|NCT05047003|Diagnostic Test|EyeBOX Model EBX-4 (Portable version)|The portable EyeBOX takes less than 4 minutes to complete and involves watching a video move around the perimeter of an LCD monitor positioned in front of the patient while a high-speed camera continuously records gaze positions. The Portable EyeBOX software detects subtle changes in eye movements consistent with concussion and calculates a BOX score.
15727202|NCT05046990|Diagnostic Test|Regular Arrangement of Collecting Venules|This is a prospective, multicentre, international study without a control group.
15727203|NCT05046977|Procedure|Single osteotomy|Single tibial osteotomy
15727204|NCT05046977|Procedure|Double Osteotomy|Double Tibial Osteotomy
15727205|NCT05046964|Device|Masimo Radical-7 Pulse CO-Oximeter|The Radical-7 Pulse CO-Oximeter uses photospectroscopy to non-invasively measure the total hemoglobin (SpHb) in a patient's blood throughout their C-section.
15727206|NCT05046951|Behavioral|Should I Screen website|The Should I Screen educational website, developed by our consultant, Rafael Meza, PhD, is available at no cost, is written at an 8th grade reading level, requires 15 minutes to use, and undergoes regular updates (https://shouldiscreen.com). The goal is to increase lung screening awareness and to encourage a shared decision making visit with a provider. Sections of the website include the benefits (the reduced likelihood of dying from lung cancer) and harms (false alarms, overdiagnosis, more testing, and invasive procedures) of screening, causes of lung cancer, methods to reduce lung cancer risk, and the lung cancer risk calculator. Improvements in knowledge have been demonstrated with individuals eligible for screening.
15727207|NCT05046951|Behavioral|Should I Screen print booklet|The Should I Screen print-based education will be developed in Aim 1 and compared to the Should I Screen website in Aim 2. It will also be at the 8th grade level and will require 15 minutes to read. Although it will contain the same topics as the website, there is one inherent difference - it is not possible to include the interactive risk calculator in the print version. The print-based version will list all of the risk criteria that are included in the algorithm so that participants can see which ones apply to them. However, the risk calculator requires the computer algorithm to calculate a person's 6-year risk of developing lung cancer.
15727208|NCT05046938|Behavioral|Motivational İnterviewing|Students with food addiction will be provided with motivational interviews about food addiction in 5 sessions, each of which varies between 6-8 groups.
15727209|NCT05046925|Procedure|postoperatively transferral to PACU|patients undergoing major thoracic and abdominal surgery will be transferred to PACU for postoperative care.
15727210|NCT05046925|Procedure|postoperatively transferral to ICU|patients undergoing major thoracic and abdominal surgery will be transferred to ICU for postoperative care.
15727211|NCT05046912|Behavioral|Yoga|8 weeks of online weekly yoga or chair yoga class
15727212|NCT05046912|Behavioral|Mindfulness|8 weeks of online weekly mindfulness class
15727213|NCT05046899|Device|BIOpH+ Psoriasis Medical Bath|20 min bath every day during 1 week and thereafter 20 min bath every second day for additional 7 weeks.
15727214|NCT05046899|Device|Cetaphil Moisturizing Lotion|Cetaphil Moisturizing Lotion will be applied on the affected body area on the same days as the BIOpH+ Psoriasis Medical Bath is performed.
15727215|NCT05046886|Behavioral|Social Cognitive Theory (SCT)-Based Behavioral Counseling|The behavioral counseling component is based on SCT, which focuses on the role played by self-referent thought in the maintenance of behavior change. Self-efficacy (e.g., the participant's confidence in their ability to engage in healthier behavior) is derived from four major sources of information: mastery experiences, social modeling, verbal persuasion, and physiological states.
15727216|NCT05046886|Behavioral|Isocaloric Mediterranean Diet Advice|<50% of calories from carbohydrates, <30% from fat, <10% from saturated fat
15727217|NCT05046886|Behavioral|Personalized Guidance to Minimize Postprandial Glycemic Response (PPGR)|Participants receive real-time feedback from the app on their predicted PPGR to meals and snacks at the time they enter them into their smart phone. PPGR predictions will be generated from the PNP algorithm, which will have required a stool sample, HbA1c, physical measurements, and a questionnaire.
15727222|NCT05046860|Drug|Dalbavancin|"The unit dose of dalbavancin administered via the peripheral venous route will be 1500 mg at each injection with a first injection at Day1, a second injection at Day15 and a third at Day36, which corresponds to 61 days of treatment with dalbavancin.
~In case of residual dalbavancin dosage at Day15 lower than 15 mg/L (rare situation) and a minimal inhibitory concentration for dalbavancin of 0.125mg/L (less than 5% of the strains), an injection every 14 days will be necessary, i.e. Day1, Day15, Day29, Day43 and Day57, which corresponds to 71 days of dalbavancin treatment.
~Rifampicin should be given orally at a dose of 600 mg on an empty stomach in the morning for patients weighing less than 70 kg and 900 mg on an empty stomach in the morning for patients weighing more than 70 kg."
15727223|NCT05046847|Drug|TQB3811|TQB3811 is a second-generation TrkA inhibitor.
15727224|NCT05046834|Other|cold application|Oral paracetamol 10 mg/kg, which is administered as standard 60 minutes before the procedure, will be given to patients who have decided to remove the chest tube by the physician and comply with the limitations of the study. After that, initial pain severity and vital signs of the patient will be recorded using FLACC 15 minutes before the start of the chest tube removal process (1.MEASURE). After this measurement, the cold gel package will be wrapped in gauze and placed directly on the skin, covering the area around the chest tube with a radius of about 5 cm. The cold gel package will remain on the skin surface for about 20 minutes. After 15 minutes, the cold package will be removed and the chest tube will be removed by the doctor.
15727225|NCT05046834|Other|cold application until 13.6 C|After measurements, the cold gel package, which rotates with one end open and forms a circle, will be wrapped in gauze and placed directly on the skin in a radius of about 5 cm, covering around the chest tube. 10 of the app. After the minute, the skin temperature will be measured with an infrared thermometer if the heat falls below 13.6 o C, the process will be terminated. If the skin temperature does not fall below 13.6 0 C, the application will continue, the application will be terminated when the heat falls below the specified temperature. After the cold package is removed, the chest tube will be removed by the doctor.
15727231|NCT05046795|Drug|Revefenacin 175 mcg in 3 ML Inhalation Solution|Revefenacin
15727232|NCT05046795|Drug|Placebo inhalation solution QD|Placebo
15727233|NCT05046782|Device|restriction spectrum imaging (RSI)|detect prostate cancer better than a standard-of-care MRI
15727234|NCT05046756|Device|mHealth App and wearable device|An intervention group (App+IoT device) uses a smart care application for 12 months. This application was tailored for colon cancer patients and created by reflecting the treatment process after surgery. And they also uses a wearable smart band for 12 months.
15727235|NCT05046743|Other|Colonic gas load|Colonic infusion of gas via an anal cannula
15727236|NCT05046743|Other|Sham load|Sham infusion of gas via an anal cannula
15727237|NCT05046730|Device|Ileostomy Reversal using Self Forming Magnets (SFM)|The magnets will be manually deployed into the small intestine during open surgery following creation of a mini or full laparotomy as clinically indicated. Once the desired segment of small bowel is resected, the magnet is inserted through the open ends of each bowel section. Once proper magnet position is confirmed and the bowel ends are approximated, the magnets couple to form the anastomosis.
15727238|NCT05046717|Device|ADAMTS13 Activity Assays|"In this study the measurement of ADAMTS13 activity will be assessed with three different commercial kits:
~HemosIL AcuStar ADAMTS13 Activity Assay (Instrumentation Laboratory, Bedford, Massachusetts, United States)
~ELISA, DG-EIA ADAMTS13 Activity (Diagnostic Grifols®, Spain)
~FRETS-VWF73 for ADAMTS13 Activity Assay
~Three kits will be used with all patients."
15727274|NCT05046496|Diagnostic Test|Intra-arterial digital subtraction angiography|Invasive intra-arterial angiography, with intra-arterial stent placement if a stenosis is confirmed
15728133|NCT05039177|Drug|Palbociclib|Administered orally
15727240|NCT05046691|Behavioral|8-week mindfulness program|The .b Foundations course is an 8-week mindfulness program developed by Mindfulness in Schools Project (MiSP) for school teachers and personnel. It includes a taster session and 8 weekly sessions. Each session lasts for 1.5 hours with a specific theme (e.g. Lesson 1 waking up from autopilot). Formal and informal mindfulness practices (e.g. mindful eating, body scan, mindful walking, habit releaser etc.), psychoeducation, cognitive exercises, inquiry, and home practice are involved.
15727241|NCT05046678|Diagnostic Test|Control|probing pocket depth (PPD)≤ 3 mm (presence of normal gingival sulcus), bleeding on probing (BOP) < 10%, clinical absence of periodontal inflammation, radiological bone loss, and any prior periodontal disease, additionally presence of anatomically intact periodontium and nonsmokers if they had no previous history of smoking
15727242|NCT05046678|Diagnostic Test|Smokers with periodontally healthy|probing pocket depth (PPD)≤ 3 mm (presence of normal gingival sulcus), bleeding on probing (BOP) < 10%, clinical absence of periodontal inflammation, radiological bone loss, and any prior periodontal disease, additionally presence of anatomically intact periodontium and smokers if they had smoked ≥10 cigarettes/day for ≥5 years
15727243|NCT05046678|Diagnostic Test|Non-smokers with gingivitis|without attachment and alveolar bone loss who had gingival inflammation, PD ≤ 3 mm and BOP > 30% in the full mouth and nonsmokers if they had no previous history of smoking
15727244|NCT05046678|Diagnostic Test|Smokers with gingivitis|without attachment and alveolar bone loss who had gingival inflammation, PD ≤ 3 mm and BOP > 30% in the full mouth and smokers if they had smoked ≥10 cigarettes/day for ≥5 years
15727245|NCT05046678|Diagnostic Test|Non-smokers with periodontitis|interdental clinical attachment level (CAL) ≥ 5 mm and PPD ≥ 6 mm on at least two non-adjacent teeth, bone loss involving the middle or apical third of the root radiographically, moderate ridge defect and ≥30% of teeth and nonsmokers if they had no previous history of smoking
15727246|NCT05046678|Diagnostic Test|Smokers with periodontitis|interdental clinical attachment level (CAL) ≥ 5 mm and PPD ≥ 6 mm on at least two non-adjacent teeth, bone loss involving the middle or apical third of the root radiographically, moderate ridge defect and ≥30% of teeth and smokers if they had smoked ≥10 cigarettes/day for ≥5 years
15727247|NCT05046665|Drug|89Zr-Girentuximab|Administration of 89Zr-girentuximab as per protocol.
15727248|NCT05046652|Biological|Convalescent Plasma Therapy|In this study, eight non-intubated Covid-19 patients confirmed by real-time viral RNA PCR tests were included. Four patients had been administered two doses of 200 mL convalescent plasma (CP) and another four patients had been administered one dose of CP with an antibody titer of 1:320.
15727249|NCT05046639|Drug|10 mL 2% lidocaine|Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL 2% lidocaine.
15727250|NCT05046639|Drug|10 mL preservative free saline|Image guided sciatic nerve anesthetic block of the contralateral limb with an injection of 10 mL preservative free saline.
15727251|NCT05046626|Other|Nutritional counseling|Intervention based on nutritional counseling under Cognitive Behavioral Theory and the used of strategies like self-monitoring, goals, cognitive restructuring and social support.
15727252|NCT05046613|Other|Rimegepant|75mg
15727253|NCT05046613|Other|Not taking Rimegepant|No rimegepant
15727254|NCT05046600|Device|Arthrex DX SwiveLock|fracture, instability, soft tissue impairment
15727255|NCT05046600|Device|PushLock Anchors|fracture, instability, soft tissue impairment
15727256|NCT05046600|Device|Headless Compression Screw|fracture, instability, soft tissue impairment
15727257|NCT05046600|Device|TRIM-IT Pins|fracture, instability, soft tissue impairment
15727258|NCT05046600|Device|Tenodesis Screws|fracture, instability, soft tissue impairment
15727259|NCT05046600|Device|FastTak Titanium|fracture, instability, soft tissue impairment
15727260|NCT05046600|Device|Bio-Suture Tak|fracture, instability, soft tissue impairment
15727261|NCT05046600|Device|Titanium Corkscrew|fracture, instability, soft tissue impairment
15727262|NCT05046600|Device|Bio-Compression Screw|fracture, instability, soft tissue impairment
15727263|NCT05046574|Other|Stroke rehabilitative therapy sessions with therapy dog present|Therapy dog will be present during stroke rehabilitative therapy sessions. This is expected to be at least three times a week per 7-day period.
15727264|NCT05046561|Drug|STRI Formula|STRI Formula is a combination of food based substances (botanicals, vitamins, minerals, and protein) with multiple, distinct, synergistic, direct and indirect antiviral effects against SARS-CoV-2
15727265|NCT05046561|Drug|Placebo|Placebo oral capsule
15727266|NCT05046548|Biological|Vaccine for intramuscular injection|Volunteers (10 at the Stage 1; 140 at the Stage 2; 150 at the Stage 3) will receive the vaccine twice spaced 14 days apart, intramuscularly, at a dose of 0.5 ml
15727267|NCT05046548|Other|Placebo comparator (without active ingredient) for intramuscular injection|Volunteers (5 at the Stage 1; 45 at the Stage 2; 50 at the Stage 3) will receive the vaccine twice spaced 14 days apart, intramuscularly, at a dose of 0.5 ml
15727268|NCT05046535|Behavioral|Sleep quality and physical activity|"Self-reported assessments will be used to measure the following: overall sleep quality, insomnia symptoms, Obstructive sleep apnea.
~Physical activity will be measured objectively using the 6MWT, 9HPT, and cardiorespiratory fitness using the VO2 submaximal test on the recumbent stepper."
15727269|NCT05046535|Genetic|Nicotine dependence|DNA sequencing for 20-25 subjects out of the whole sample will be performed. Sanger sequencing to all subjects will also be performed to identify related genes
15727270|NCT05046535|Diagnostic Test|Nicotine and cotinine serum levels|Cotinine serum level which is a major metabolite of nicotine and the preferred biomarker for measuring tobacco use will be measured together with nicotine levels using Liquid Chromatography-Tandem Mass Spectrometry (LC-MS/MS).
15727271|NCT05046535|Behavioral|Smoking|Surveys that measure nicotine dependence and smoking behavior
15727272|NCT05046522|Drug|Palmitoylethanolamide sold as Levagen +|Investigational product to be taken as a 700mg (2 x 350mg) dosage at onset of migraine. If unresolved at 2 hours post onset of migraine, a second dose of 700mg (2 x 350mg) is to be taken.
15727273|NCT05046522|Drug|Placebo comparator - maltodextrin and microcrystalline cellulose mix|Placebo product to be taken as a 700mg (2 x 350mg) dosage at onset of migraine. If unresolved at 2 hours post onset of migraine, a second dose of 700mg (2 x 350mg) is to be taken.
15727275|NCT05046457|Dietary Supplement|Beta-cryptoxanthin (BCX)|Subjects will be randomised into one of the three study treatment arms.
15727276|NCT05046444|Diagnostic Test|Next Generation Sequencing|NON-Interventional Observation only study comparing sequencing-only approaches to classical diagnostic methods
15727277|NCT05046431|Drug|BAT2506|50mg/0.5mL
15727278|NCT05046431|Drug|EU Simponi|50mg/0.5mL
15727279|NCT05046418|Other|Hypoallergenic formula containing synbiotics|An extensively hydrolysed formula containing synbiotics or an amino acid formula containing synbiotics.
15727280|NCT05046405|Device|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation (tDCS) has been suggested to the peripartum period combining antidepressant eﬀects with low risks. In tDCS a low intensity constant current is delivered to the scalp with sub-threshold eﬀect on neurons' resting membrane potential. Long stimulation sessions lead to lasting eﬀects and neuroplastic changes. Local tDCS eﬀects target calcium-dependent synaptic plasticity and distal eﬀects alter the networks' connectivity, synchronicity and oscillatory patterns. tDCS applications aim to counteract the hypoactivity of the frontoparietal network and the left sided hyperactivity of the default mode network associated with depressive symptoms.
15727283|NCT05046353|Drug|D-serine|Auditory remediation +/-D-serine
15727284|NCT05046353|Other|Placebo|Auditory remediation +/-D-serine
15727285|NCT05046340|Other|Passive leg raising|We perform the PLR test by adjusting the bed and not by manually raising the patient's legs. Bronchial secretions must be carefully aspirated before PLR. If awake, the patient should be informed of what the test involves. And measure the cardiac output by using certain devices at the bedside. The end-expiratory occlusion consists in interrupting the ventilator at end-expiration for 15-30 s and assessing the resulting changes in cardiac output.
15727287|NCT05046314|Biological|TK216+Vincristin|TK216 was continuously administered for 14 days，then rest for 14 days. Vincristin is given before TK216 only in the first day of each cycle, the first cycle of VCR is 0.75mg/m^2 and 1.5mg/m^2 from the second cycle，every 28 days is a study cycle.
15727288|NCT05046301|Procedure|Biospecimen Collection|Correlative studies
15727289|NCT05046301|Other|Contrast Agent|Given IV
15727290|NCT05046301|Procedure|Contrast-Enhanced Mammography|Undergo contrast-enhanced mammography
15727291|NCT05046301|Other|Questionnaire Administration|Ancillary studies
15727292|NCT05046288|Other|Virtual guided tours|The intervention is a participatory art-based activity which consists in MMFA virtual guided tours. Each virtual guided tour is performed with a group of 6 to 7 participants. They meet online one time per week for a 30 to 45 min of a guided tour during a 3-month period. Each tour is different and supervised by a MMFA trained guide.
15727293|NCT05046275|Other|Data analysis|No intervention, data analysis only
15727294|NCT05046262|Drug|Calcium chloride|Calcium electroporation
15727295|NCT05046236|Other|Interactive POWER rehabilitation|Interactive POWER rehabilitation training for twice a week, total 12 weeks, that consisted of 6 types of equipment for strength training.
15727296|NCT05046236|Other|Conventical physical training|Conventional physical training models in current clinical use for twice a week, total 12 weeks, that consisted of strength training, balance training, stretching, gait training, and etc.
15727297|NCT05046223|Procedure|The responses to bronchoscopic insertion for bronchoscopic interventions such asTBNA, Cryotherapy, etc.|cough response, the changes of BP, HR, SpO2, Trans dermal CO2 during bronchoscopic interventions
15727298|NCT05046223|Procedure|postoperative recovery|anesthetic recovery in postoperative care unit recovery of swallowing by questionnaire in POD1
15727299|NCT05046210|Behavioral|LHA intervention|The participants in the EG received 4 lessons from a LHA over 4 weeks. Four lessons were taught one-on-one once a week by a certified LHA at the participants' homes. The lessons including understand oral structure, learn oral self-care skills and oral function promotion, understand the status of oral self-care and the relationship between oral diseases and systemic diseases, understand swallowing dysfunction and safe eating skills and review.
15727300|NCT05046210|Behavioral|Oral exercise intervention|Oral exercise intervention is designed to increase the range of movement in tongue, lips, and jaw as well as salivary gland massages, which will help speech and/or swallow functioning. All participants performed oral exercise before three meals a day.
15727301|NCT05046184|Drug|Ketamine Hydrochloride|Subjects with MDD will receive 2 weeks of twice-weekly 40-minutes long IV infusion of ketamine (0.5 mg/kg). Ketamine will be dissolved in 0.9% saline in a total volume of 100 mL and administered with an infusion pump at a constant rate.
15727302|NCT05046184|Drug|Midazolam injection|Subjects with MDD will receive 2 weeks of twice-weekly 40-minutes long IV infusion of midazolam (0.02 mg/kg). Midazolam will be dissolved in 0.9% saline in a total volume of 100 mL and administered with an infusion pump at a constant rate.
15727303|NCT05046171|Other|Pharmacist-led deprescribing|A pharmacist recruited onto the study will review the patient's current medication list and develop a list of targeted recommendations for deprescribing using the 3-step potentially inappropriate medications identification method.
15727304|NCT05046171|Other|Patient education|Subjects receive a written pamphlet about deprescribing.
15727383|NCT05045391|Diagnostic Test|Aspergillus IgG detection|Aspergillus IgG will be detected among pulmonary tuberculosis patients. 5 ml of vein blood will be collected for ELISA.
15727305|NCT05046158|Device|Transforming Powder Dressing|Altrazeal transforming powder dressing is methacrylate-based powder dressing made from the same materials used in the production of contact lenses. Upon hydration, the powder transforms into a moist, non-occlusive barrier that covers and protects the wound from exogenous bacteria while helping manage exudate through vapor transpiration.
15727306|NCT05046158|Other|Standard of care topical wound agents and dressings|Standard wound dressings such as gauze or foams. Moisture regulating topical agents may also be used to prepare the wound bed.
15727307|NCT05046145|Behavioral|speech therapy for chewing + real tDCS|participants will be instructed to chew their food correctly during the tDCS session, but the participant does not know if the tdcs is real or sham.
15727312|NCT05046106|Drug|MLC1501|Powdered extract of Radix astragali, Rhizoma chuanxiong, Radix angelica sinensis, Radix polygala
15727313|NCT05046106|Other|Placebo|Caramel, chocolate brown, flavor (E_1982648), dextrin
15727314|NCT05046093|Diagnostic Test|Transbronchial cryobiopsy|"When the lung nodule is visualized by thin bronchoscope (4mm) with R-EBUS, cryobiopsy is performed. If not visualized, ultrathin (3mm) bronchoscope is used.
~Cryobiopsy is initially performed with 1.7mm cryo-probe. In case of cryo-probe insertion failure (Ex: acute angle, unparallel pathway between cryo-probe and guide sheath on fluoroscopy), 1.1mm cryo-probe is used."
15727315|NCT05046080|Other|Electronic Health Record Review|Medical records reviewed
15727316|NCT05046080|Other|Laboratory Biomarker Analysis|Correlative studies
15727317|NCT05046067|Procedure|Computed Tomography|Undergo CT
15727318|NCT05046067|Procedure|Therapeutic Conventional Surgery|Undergo surgery per standard of care
15727321|NCT05046041|Drug|Mifepristone + Misoprostol|A single 200 mg mifepristone (one tablet) to be taken orally either at home or at the hospital, followed approximately 24 - 48 hours later with administration of 400 mcg misoprostol. Repeat doses of 400 mcg (two tablets) of misoprostol will be administered buccally (buccal) every three hours until the abortion is achieved.
15727322|NCT05046028|Dietary Supplement|Oral nutritional supplements (ONS) with a cooling effect + ONS without a sensor component and taste + standard diet|ONS with a cooling effect and Red Fruits taste. 3 bottles (х 200 ml) per day X 14 days (at severe mucositis period) in addition to a standard diet and other ONS without a sensor component and taste according to protein and energy requirements based on ESPEN guidelines (protein 1.5 g/kg/day and Energy -25 and 30 kcal/kg/day)
15727323|NCT05046028|Dietary Supplement|ONS without a sensor component and taste + standard diet|Nutritional support + ONS without a sensor component and taste (cooling effect) in addition to a standard diet according to protein and energy requirements based on ESPEN guidelines (protein 1.5 g/kg/day and Energy -25 and 30 kcal/kg/day)
15727324|NCT05046028|Dietary Supplement|Standard diet|Without appropriate nutritional support - not in accordance with current ESPEN guidelines (protein and Energy intake less than 1.5 g/kg/day and 25 and 30 kcal/kg/day). (Historical retrospective control).
15727325|NCT05046015|Other|10% Urea foot lotion|"During the course of the study participants cleanse one foot (previously randomized) once daily using the mild cleanser Cetaphil® Restoraderm Body Wash and apply the product Excipial® U10 Lipolotion 10% Urea once daily in the evening by themselves."
15727326|NCT05046015|Other|10% Urea foot ointment|"During the course of the study participants cleanse one foot (previously randomized) once daily using the mild cleanser Cetaphil® Restoraderm Body Wash and apply the product Excipial® U10 ointment10% Urea once daily in the evening by themselves."
15727327|NCT05045989|Behavioral|Residence-based testing participation pilot (SARS-CoV-2 testing with relaxed social distancing restrictions)|SARS-CoV-2 asymptomatic saliva testing (as available to all students at staff at the participating university) delivered with relaxed social distancing (behavioural element) in two halls of residence.
15727328|NCT05045976|Other|Web-based interactive self-management support program|The intervention group will receive a 60-90 minute introduction to the web-based interactive self-management support program. They will be instructed to do the weekly online self-assessment on symptoms, emotion, and health behaviors and how to use the web-based program to manage their health by applying self-manage skills and behavior change techniques. The contents of the interactive colorectal cancer self-management website include the following five main components: Health Support Station, Knowledge Supply Station, Sharing Stories, My Dear Friend, and Asking a Nurse.
15727329|NCT05045963|Other|Electronic Health Record Review|Medical record reviewed
15727330|NCT05045950|Drug|Memantine -Twice Daily or Extended Release|"Both extended release memantine and twice daily memantine dosing will be allowed.
~Twice daily dosing:
~The target dose for memantine is 20 mg (10 mg divided twice daily). Dose will be escalated by 5 mg each week to a target of 10 mg twice daily (i.e., 5 mg a day on week 1, then 5 mg twice daily (BID) on week 2, then 10 mg in AM plus 5 mg in PM on week 3, followed by 10 mg in AM plus 10 mg in PM by week 4).
~Extended Release Memantine:
~The target dose for extended release memantine is 28 mg. Dose will be escalated by 7 mg per week to a target of 28 mg daily (i.e., 7 mg a day on week 1, then 14 mg a day on week 2, then 21 mg a day on week 3, followed by 28 mg a day by week 4)."
15727331|NCT05045950|Radiation|WBRT utilizing the PRDR technique|The total dose of 3000 cGy (30 Gy) will be divided 10 fractions of 300 cGy (3 Gy); each fraction will be delivered as a series of 20 cGy (0.2Gy) pulses separated by 3 min time intervals. 20 cGy / 3 min = 6.67 cGy/min (or 0.0667 Gy/min). Total time is determined by the fractionated series and time intervals, meaning 300cGy/20cGy = 15 division x 3 minutes = 45 minutes. Including time to set up, approximate total time per treatment session will be 60 minutes.
15727332|NCT05045937|Drug|Ivermectin|Ivermectin treatment of outpatients dosing at 0.4mg/kg until recovered along with supplemental treatment using a multi-modal approach.
15727333|NCT05045911|Procedure|Endoscopic Barbed-clips Suturing|Endoscopic Barbed-clips Suturing
15729020|NCT05032144|Drug|STSA-1002 injection|Intravenous injection
15727334|NCT05045898|Other|plantar massage|The patients will be given a classical massage, known as Swedish massage, consisting of euflorage and petrissage. While the patient is lying in the supine position, a classical massage will be applied to the plantar face, dorsum and toes of both feet, which will take approximately 20 minutes in total. It will last for 6 weeks, 3 days a week.
15727335|NCT05045898|Other|textured insoles|"Textured insoles will be prepared in accordance with the principles stated by Waddington et al. in 2003. In the studies of Waddington et al., ethyl vinyl acetate (EVA) textured insoles with 4 hemispherical protrusions per cm² were used. The height of each hemispherical protrusion from the EVA floor is 2 mm; The height of the insoles from the ground is 3 mm.
~The textured insoles will be prepared by an orthotic prosthesis center by cutting the EVA layer with the above-mentioned features in accordance with the patient's shoe/home shoe insoles and placing them on the shoe/home shoe insoles. Insoles will be provided free of charge to patients. Patients will be asked to wear their shoes/house shoes with insoles while performing activities inside and outside the home for 6 weeks."
15727336|NCT05045872|Drug|domestic polysaccharide superparamagnetic iron oxide nanoparticle|Patients will receive contrast-enhanced renal artery magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle before renal angiography.Patients received intravenous polysaccharide superparamagnetic iron oxide nanoparticle before magnetic resonance imaging.
15727337|NCT05045859|Behavioral|CBCT for PTSD|CBCT for PTSD is a 15-session, manualized therapy developed by Monson and Fredman, designed to simultaneously improve PTSD symptoms and enhance relationship functioning. It assumes that PTSD exists within the couple's relationship and that partners can join together to reduce the presence of PTSD in their relationship. Sessions are organized into three phases of treatment: (1) psychoeducation about PTSD and relationships; (2) behavioral interventions to enhance relationship functioning; and (3) dyadic cognitive intervention designed to contextualize trauma memories and address trauma-relevant cognitions held by either partner that keep the PTSD and/or relationship distress alive. Out-of-session assignments are designed to assist the couple in reinforcing skills learned in the sessions.
15727339|NCT05045820|Procedure|acupuncture|"Acupuncture treatment will both main and supplementary acupoints. Main points include GB30; ST36; LI11- LI4, GB34-SP6; LR3, SP10, DU24, DU20, Yin Tang, Ear Shen Men which are chosen based on the unique clinical features of sickle pain. The remaining individualized acupoints will be selected and manipulated with manual acupuncture with appropriate needling techniques based on the individual Syndrome (reinforce or reduce or Non reinforce or reduce) that is determined by TCM diagnosis. Acupuncture treatment will last 30 minutes per session and will be administered two times per week for 5 weeks, each subject will receive one course of treatment which contains 10 treatment sessions."
15727340|NCT05045820|Other|Sham|"Non-Tradition Acupuncture or a Placebo Comparator will be used as sham acupuncture which uses mock laser acupuncture approach. Laser acupuncture device VitaLaser 650 (Lhasa OMS, Weymouth, MA or similar) will be positioned 1-2cm over all of the same acupoints used in verum acupuncture treatment above. No palpation is administered prior to positioning the device and there is no physical contact between device and skin. The laser will not be turned on during the treatment. Sham treatment will also last 30 minutes per session and will be administered two times per week for 5 weeks, each subject will receive one course of sham treatment which contains 10 treatment sessions."
15727341|NCT05045807|Dietary Supplement|Meat with added nitrate|Prosciutto/pancetta/Parma ham/salami (all derived from pork) prepared by a commercial butcher with the sodium nitrate and nitrite as an additive.
15727342|NCT05045807|Dietary Supplement|Meat with added nitrate plus vegetables|"The same intervention as of intervention meat with added nitrate consumed together with mixed vegetables."
15727343|NCT05045794|Device|VitaSmart Liver Machine Perfusion System|Following donor liver retrieval, preservation using static cold storage, and back table preparation in the transplant center operating room, the organ will be flushed with Belzer UW Machine Perfusion Solution (MPS) and perfused through the cannulated portal vein using cold, actively oxygenated MPS that is circulated at low pressure for 90 minutes to 5 hours. After disconnection from the device, donor liver implantation and reperfusion will proceed in accordance with institutional care standards.
15727344|NCT05045794|Other|Static cold storage|Donor liver retrieval and preservation using standard of care cold storage methods
15727345|NCT05045781|Drug|Eptinezumab|single iv infusion
15727346|NCT05045768|Drug|(Gelsectan, Noventure)|Patients included in the study will receive for 28 days a capsule containing Xyloglucan, Pea Protein and Grape Seed Extract and a prebiotic Xylo-oligosaccharide (Gelsectan, Devintec sagl) twice daily.
15727347|NCT05045755|Biological|Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)|The bivalent HPV-16/18 vaccine was a mixture of two aluminum hydroxide adjuvant-absorbed recombinant L1 VLPs of HPV-16 and HPV-18 expressed in E. coli. A 0.5 ml dose of the bivalent HPV test vaccine comprised 40 μg of HPV-16 and 20 μg of HPV-18 L1 VLPs absorbed with 208 μg of aluminum adjuvant
15727348|NCT05045742|Other|Traditional vital sign alarms versus the BioVitals Index vs the National Early Warning Score 2|We will retrospectively compare the alarms produced from traditional vital sign alarms (thresholds set by clinicians) versus the BioVitals Index vs the National Early Warning Score 2
15727349|NCT05045716|Drug|Lecanemab|Lecanemab IV infusion.
15727350|NCT05045716|Drug|Lecanemab|Lecanemab SC injection.
15727351|NCT05045703|Dietary Supplement|Vitamin A palmitate|Vitamin A palmitate, 15,000 IU daily for 4 months
15727352|NCT05045677|Other|digital DBT skills intervention|The digital intervention consists of 6 modules that will be delivered over 6 to 10 days. The modules cover mindfulness skills, emotion regulation skills and distress tolerance skills.
15727353|NCT05045677|Other|Standard Care|Standard inpatient care includes a multi-disciplinary team approach including daily psychiatric review, medication management and in-person psychosocial interventions (social work, nursing).
15727354|NCT05045664|Radiation|Standard|12 x 2 Gy involved site radiotherapy plus Rituximab
15727355|NCT05045664|Radiation|Experimental|2 x2 Gy involved site radiotherapy plus Obinutuzumab
15727356|NCT05045664|Drug|Standard|Rituximab with 12 x 2 Gy involved site radiotherapy
15727357|NCT05045664|Drug|Experimental|Obinutuzumab with 2 x2 Gy involved site radiotherapy
15727358|NCT05045651|Procedure|Gender Solution®posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA and standard posterior stabilized NexGen® LPS Hi-Flex; Zimmer Biomet, Inc, Warsaw, IN, USA|gender specific knee prosthesis:design for female to restore Q-angle, reduce anteroposterior (AP)/mediolateral(ML) ratio for reducing overhang of femoral component, increase valgus angle of trochlea groove, and reduce thickness of anterior part of prosthesis for prevention overstuff with patella. The standard TKA or unisex knee prosthesis was design for female and male.
15727361|NCT05045625|Device|HD Study Electrode|The HD Study Electrode is an array of 8 columns of stimulation contacts arranged in 8 rows with a low-volume electrode body. This array of stimulation electrodes contact patterns of bi-poles and tri-poles may be applied to the spinal cord for assessment of dermatomal selective stimulation patterns.
15727362|NCT05045612|Other|Stop antibiotic therapy|Stop antibiotic therapy instituted by the admitting physician
15727363|NCT05045599|Behavioral|Capacity Building of Health care workers and providers to deliver integrated Family Planning and Maternal, Newborn and Child Health|Community engagement to improve awareness, and use of family planning products and services
15727364|NCT05045586|Device|The tunnel technique for root coverage with CTG without Cross-linked Hyaluronic Acid|The tunnel technique for root coverage with CTG without Cross-linked Hyaluronic Acid
15727365|NCT05045586|Device|The tunnel technique for root coverage with CTG andCross-linked Hyaluronic Acid|The tunnel technique for root coverage with CTG andCross-linked Hyaluronic Acid
15727366|NCT05045534|Drug|Comparison of TB-840 treatment with Placebo|Single dose or Multiple Dose of TB-840 treatment
15727367|NCT05045521|Other|plyometric warm up group|"participants will be asked to do 10 minutes self-paced jog on motorized treadmill.
~During the plyometric intervention, subjects will perform the 2 * 8 squat jumps, 2 * 8 scissor jumps, and 2 * 8 double leg bounds (2 sets of 8 repetitions) as a part of warm-up, and will have 60 s to recover between each set. Prior to the intervention, participants will be shown the technique to be used during jumping through use of three videos."
15727368|NCT05045521|Other|resistance warm up|"participants will be asked to do 10 minutes self-paced jog on motorized treadmill.
~After the jog participants will perform the 6*10s strides with the 15% of the weight. Velocity of the strides will be controlled by the participants.
~Warmup will be followed by the 10minutes rest"
15727369|NCT05045521|Other|control warm up group|"participants will be asked to do 10 minutes self-paced jog on a motorized treadmill.
~After the jog participants will perform the 6*10s strides without the weight. Velocity of the strides will be controlled by the participants. Warmup will be followed by the 10minutes rest The total amount of time spended in each of the three warm-up protocols will be recorded. Participants will be instructed to wear the same pair of running shoes during the three tests."
15727370|NCT05045508|Drug|OC-01 (varenicline 0.6mg/ml) nasal spray|OC-01 nasal spray which contains varenicline is being developed by Oyster Point Pharma for the treatment of signs and symptoms of DED. OC-01 (varenicline) nasal spray activates the trigeminal parasympathetic pathway and stimulates natural tear production and bathe the corneal nerve endings in a protective layer of tear film. In addition, OC-01 (varenicline) acts as a cholinergic agonist and may provide analgesia by activating the trigeminal parasympathetic pathway.
15727371|NCT05045508|Drug|Placebo (vehicle) Nasal Spray|Placebo (vehicle) nasal spray [control]
15727372|NCT05045495|Diagnostic Test|Sucrose Hydrogen Methane Breath Test|Subjects will collect 2 buccal swabs for the sucrase genetic test and then subjects will simultaneously conduct the sucrose challenge test, sucrose hydrogen methane breath test, and the 13C-sucrose following ingestion of 50-grams of sucrose (table sugar) mixed with 8 ounce of water.
15727373|NCT05045482|Drug|Saroglitazar Magnesium 1 mg|Group-8: Total of 12 subjects will be enrolled in the Group-8. Group 8A (n=3, consist of mild hepatic impairment subjects); Group 8B (n=3, consist of moderate hepatic impairment), Group 8C (n=3, consist of severe hepatic impairment and Group 8D (n=3, consist of control subjects with normal hepatic functions).
15727374|NCT05045482|Drug|Saroglitazar Magnesium 2 mg|Group-9: Total of 12 subjects will be enrolled in the Group-9. Group 9A (n=3, consist of mild hepatic impairment subjects); Group 9B (n=3, consist of moderate hepatic impairment), Group 9C (n=3, consist of severe hepatic impairment and Group 9D (n=3, consist of control subjects with normal hepatic functions).
15727375|NCT05045469|Drug|dian dao san|dian dao san and placebo will be used in the rosacea lesions twice a day for 6 weeks
15727376|NCT05045456|Device|Cardiologs Platform|Two Apple Watch recordings (one recording with the watch on the wrist and one on the left side of the abdomen) interpreted by Cardiologs AI done simultaneously with each 12-lead ECG
15727377|NCT05045443|Drug|Curcumin|Tumeric curcumin 500 mg per oral capsule of Puritans Pride company supplement
15727378|NCT05045443|Dietary Supplement|Standard of Care|As per institution protocol for Standard of nutritional Care
15727379|NCT05045430|Device|Silver II Non-Woven Dressing|"Assigned interventions Subjects will undergo treatment of their chronic and acute wounds as indicated in instructions for use with Silver II Non-Woven dressings.
~Subjects will be evaluated as follows:
~Full Patient and wound assessment, Informed consent. Wound Assessment, application of dressings, (At each scheduled dressing change.) Wound Assessment, removal of dressings, (At each scheduled dressing change.) The patients will be evaluated at each dressing change over six-week period (per Advanced Medical Solution Product) or until the wound is healed to extent that the use of Silver II Non-Woven dressing is no longer indicated from the time that the patient has been recruited.
~The assessment of the presence and reduction of the signs and symptoms of Infection."
15727380|NCT05045417|Diagnostic Test|Serum level of IL-17|"Measurement of serum level of IL-17 :
~To explore the role of IL-17 in systemic lupus erythematosus
~To determine the relation between IL-17 and lupus disease activity
~To analyze the correlation between IL-17 and internal organ affection (lupus nephritis , interstitial lung disease)"
15727381|NCT05045404|Drug|Poziotinib Hydrochloride|"1429757-68-5, HM781-36B, NOV-1201 Hydrochloride, NOV120101 Hydrochloride, Poziotinib HCl, POZIOTINIB HYDROCHLORIDE
~Given PO"
15727382|NCT05045404|Biological|1429757-68-5, HM781-36B, NOV-1201 Hydrochloride, NOV120101 Hydrochloride, Poziotinib HCl, POZIOTINIB HYDROCHLORIDE|"Biological/Vaccine Ramucirumab 947687-13-0, anti-VEGFR-2 fully human monoclonal antibody IMC-1121B, Anti-VEGFR-2 Fully Human Monoclonal Antibody IMC-1121B, Cyramza, IMC-1121B, IMC-1121B, LY3009806, Monoclonal Antibody HGS-ETR2, ramucirumab, RAMUCIRUMAB
~Given IV"
15728325|NCT05037487|Drug|20 mg CBD + 20 mg THC Cannabis|Smoked cannabis with CBD and THC
15727388|NCT05045339|Procedure|Ball Exercises|Different ball exercises which include stability ball roll, stability ball hug, catching, throwing was performed. Along with these exercises, ball tapping exercise was also performed. Exercises were performed with 55 and 65 inch gym ball and a small regular plastic ball.
15727389|NCT05045326|Behavioral|Smoking cessation program|"Participants will receive intensive treatment for smoking cessation during day hospital admission.
~The intervention is carried out individually and in an open-ended group. The treatment, provided by trained and multidisciplinary professionals (nursing, psychiatry, psychologist, occupational therapist, social work), includes psychological, psycho-educational support, and pharmacological treatment advice.
~The group intervention takes place once a week and is divided into six structured sessions that are repeated. Sessions include nicotine addiction and withdrawal, health consequences, benefits of quitting, motivation for change, triggers, coping responses, social support, decision making, pharmacological treatment advice and healthy lifestyle habits."
15727390|NCT05045326|Behavioral|Placebo Comparator: Brief Counselling|Participants will receive brief counseling on smoking cessation during their hospital stay. This brief intervention is based on motivational techniques to increase motivation to reduce tobacco use or to initiate treatment.
15727391|NCT05045313|Drug|Warfarin sodium tablets|Drug: Warfarin sodium, tablet, oral
15727392|NCT05045313|Drug|Digoxin tablet|Drug: Digoxin, tablet, oral
15727393|NCT05045313|Drug|Probenecid tablets|Drug: Probenecid, tablet, oral
15727394|NCT05045313|Drug|DBPR108 tablets|Drug: DBPR108, tablet, oral
15727395|NCT05045300|Procedure|Ultrasound guided Selective trunk block|High definition ultrasound images that were acquired during USG SeTB are routinely stored in the hard disk of ultrasound machine in DICOM (Digital Imaging and Communications in Medicine) format will be used for this review. The images of principal investigator's previous research studies with Clinical trial registration: NCT04752410 and NCT04773405 will also be retrieved. The ultrasound imaging was performed before (scout scan), during and immediately after the USG SeTB. As is the principal investigator's standard practice, all ultrasound scan was performed in a sequential manner (SUIT: Sequential Ultrasound Imaging Technique) with the orientation marker of the transducer directed laterally so as to obtain a transverse oblique view of the brachial plexus block at the supraclavicular fossa. Approximate 50 cases who had undergone USG SeTB for surgical anesthesia during upper extremity surgery since January 1 2020 to June 30, 2021 will be evaluated by two anesthesiologists.
15727396|NCT05045287|Radiation|hypofractionated radiotherapy|Undergo hypofractionated RT，obeserve reconstruction failure，cosmetic result and recurrence rate
15727397|NCT05045274|Drug|Dapagliflozin 10Mg Tab|"Dapagliflozin: It will be given in a dose of 10 mg once daily within 24 hours after PPCI.
~Reperfusion therapy: primary percutaneous coronary intervention (PPCI) after DAPT loading (aspirin 300 mg and either clopidogrel 600mg or ticagrelor 180 mg orally) in the ambulance or emergency department upon diagnosis.
~Anti-ischemic treatment: DAPT, SC-anticoagulation, beta blockers, statin or others will be individualized according to the patient condition.
~Anti-failure treatment: Angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, mineralocorticoid receptor antagonists, other diuretics will be added in case of volume overload."
15727398|NCT05045274|Drug|Placebo|"Reperfusion therapy: primary percutaneous coronary intervention (PPCI) after DAPT loading (aspirin 300 mg and either clopidogrel 600mg or ticagrelor 180 mg orally) in the ambulance or emergency department upon diagnosis.
~Anti-ischemic treatment: DAPT, SC-anticoagulation, beta blockers, statin or others will be individualized according to the patient condition.
~Anti-failure treatment: Angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, mineralocorticoid receptor antagonists, other diuretics will be added in case of volume overload."
15727399|NCT05045261|Drug|administration of SLGN in arm C|administration of 3mg SLGN weekly for 24 weeks in arm C
15727400|NCT05045261|Drug|Discontinuation of NUC treatment in arms B and C|NUC treatment will be stopped after 28 weeks in arms B and C
15727401|NCT05045248|Drug|Apraclonidine Hcl 0.5% Oph Soln|Each patient is administered 2 drops of Apraclonidine 0.5% solution to the most affected eye
15727402|NCT05045209|Other|Virtual rehabilitation|Patient who are assigned to this group will receive virtual rehabilitation
15727403|NCT05045196|Behavioral|Health promoting conversations|The Health-promoting conversations intervention is a conversation model between the patient, family members, and a trained nurse. Patients and families included in the study will, after submitting base-line-data, be randomized to
15727404|NCT05045183|Device|SoC Adhesive Bandage|On the randomized wound site, a SoC adhesive bandage will be applied.
15727405|NCT05045183|Drug|Antibiotic Ointment|On the randomized wound site, a antibiotic ointment will be applied.
15727406|NCT05045183|Drug|Antiseptic Wash|On the randomized wound site, a antiseptic wash will be applied.
15727407|NCT05045183|Device|Hydrocolloid Pad|On the randomized wound site, hydrocolloid pad will be applied.
15727408|NCT05045170|Drug|Influence of propofol sedation on memory consolidation and 'working memory'|Spinal anesthesia is performed by anesthesiologist. Memory testing is conducted immediately prior to propofol sedation (stage 1), 5-10 minutes after the start of propofol sedation (stage 2), 10 minutes after propofol sedation is finished and consciousness is restored (stage 3). Five emotionally neutral words are heard by the patients twice at each stage to assess the impact of sedation on memory consolidation. The patients repeat the memorized words after each audition. To assess the effect of sedation on the 'working memory', anesthesiologist asked the patient to remember and reproduce the memorized words five minutes after learning in the second stage. Approximately, 24 hours after the end of anesthesia, recall and recognition of the experimental words are tested. The number of words in recall and recognition testing is recorded by researcher.
15727409|NCT05045170|Drug|Influence of dexmedetomidine sedation on memory consolidation and 'working memory'|Spinal anesthesia is performed by anesthesiologist. Memory testing is conducted immediately prior to dexmedetomidine sedation (stage 1), 5-10 minutes after the start of dexmedetomidine sedation (stage 2), 10 minutes after dexmedetomidine sedation is finished and consciousness is restored (stage 3). Five emotionally neutral words are heard by the patients twice at each stage to assess the impact of sedation on memory consolidation. The patients repeat the memorized words after each audition. To assess the effect of sedation on the 'working memory', anesthesiologist asked the patient to remember and reproduce the memorized words five minutes after learning in the second stage. Approximately, 24 hours after the end of anesthesia, recall and recognition of the experimental words are tested. The number of words in recall and recognition testing is recorded by researcher.
15727410|NCT05045170|Drug|Influence of spinal anesthesia on memory consolidation and 'working memory'|Spinal anesthesia is performed by anesthesiologist. Memory testing is conducted immediately prior to operation (stage 1), 5-10 minutes after the start of operation (stage 2), 10 minutes before the end of operation (stage 3). Five emotionally neutral words are heard by the patients twice at each stage to assess the impact of sedation on memory consolidation. The patients repeat the memorized words after each audition. To assess the effect of sedation on the 'working memory', anesthesiologist asked the patient to remember and reproduce the memorized words five minutes after learning in the second stage. Approximately, 24 hours after the end of anesthesia, recall and recognition of the experimental words are tested. The number of words in recall and recognition testing is recorded by researcher.
15727411|NCT05045157|Procedure|Percutaneous A1 Pulley Release Under Ultrasound Guidance|the A1 pulley is cut off with Ultrasound guidance by a percutaneous insertion of the small needle under local anaesthesia.
15727412|NCT05045157|Drug|Corticosteroid injection|corticosteroid injection is performed
15727418|NCT05045131|Procedure|Left atrial combined pulmonary vein isolation and posterior wall isolation|
15727419|NCT05045118|Other|Digital Structured Patient Education Material|Participants of home-based Cardiac Rehabilitation Program that are included in this research will be provided with a digital Structured Patient Education Material at the beginning of the program, and will be followed up for 12 weeks duration
15727420|NCT05045105|Other|Time necessary for ICP catheter placement by Intensive Care Physician vs Neurosurgeon following indication|Time necessary for ICP catheter placement by Intensive Care Physician vs Neurosurgeon following indication and complications related to the maneuver between the two cohorts will be evaluated and compared.
15727421|NCT05045079|Procedure|Inferior Vena Caval (IVC) Occlusion maneuver|During standard of care right heart catheterization (RHC), a second catheter will be inserted next to the catheter that was placed for the RHC in the jugular vein or femoral vein to assess the degree of pericardial restraint from the severe tricuspid regurgitation that may increase left sided filling pressures.
15727422|NCT05045066|Dietary Supplement|Cholecalciferol|Given PO
15727423|NCT05045066|Other|Quality-of-Life Assessment|Ancillary studies
15727424|NCT05045053|Drug|Xiidra 5% Ophthalmic Solution|lifitegrast 0.5% ia applied twice daily after corneal collagen cross linking
15727425|NCT05045040|Behavioral|Mobile-based empathic communication support program to promote ACP discussion|Patients in the intervention group will be provided a mobile-based empathic communication support program- an app on a mobile phone. The app comprises QPL (46 questions in eight categories) and questions about the patient preferred treatment and end-of-life based on the values and goals of the patient's life. They can then proceed with the content themselves, at home or anywhere, at any time. Between app registration and the next outpatient visit, the patient will be interviewed (by phone or in person) by a nurse or by a clinical psychologist, who will help them prepare for the discussion with the physician and ask questions based on the patient's app responses for 30 minutes to an hour. During the outpatient visit, patients and their physicians will be provided a feedback based on the interview. The duration between the start of app use and the next consultation is a minimum of one week and a maximum of four weeks.
15727426|NCT05045027|Procedure|Biospecimen Collection|Undergo collection of tissue samples
15727427|NCT05045027|Procedure|Diagnostic Imaging|Undergo multinuclear metabolic imaging
15727428|NCT05045027|Procedure|Magnetic Resonance Imaging|Undergo MRI
15727429|NCT05045014|Other|Balance assessment|Romberg test and one-leg standing test will be used.
15727430|NCT05045014|Other|Unterberger test|During 50 steps, he will count in place with 45 degrees of hip flexion, and after 50 steps, the angle of rotation between the first position and the final position of the right foot will be measured with the help of a goniometer and the displacement distance.
15727431|NCT05045014|Other|Corsi Block Tapping (mobıl app)|Spatial memory will be evaluated.
15727432|NCT05045014|Other|Navigation performance|Two triangles (one equilateral, one oblique triangle, at 30°, 60° and 90° angles respectively) with route segment lengths between 150 and 300 cm will be marked on the floor and the participants will be asked to complete the task with their eyes closed. The final deviation amount will be recorded.
15727433|NCT05045014|Other|Cobb angle measurement|It will be evaluated with the help of X-ray.
15727434|NCT05045014|Other|Scolio Detector (mobıl app)|The degree of rotation will be measured with the mobile application called Scolio Detector.
15727435|NCT05044988|Drug|HS-10342|HS-10342 tablet once daily from Day 1 to 21 of a 28-day cycle
15727436|NCT05044975|Behavioral|Sleep restriction|Participants will receive sleep restriction intervention
15727437|NCT05044975|Behavioral|Stimulus control|Participants will receive stimulus control intervention
15727438|NCT05044975|Behavioral|Systematic light exposure|Participants will receive systematic light exposure intervention
15727439|NCT05044962|Drug|Cabotegravir/ Rilpivirine|"For initial injection participants will be given CABENUVA 600-mg/900-mg Kit: (single-dose vial of 600 mg/3 mL (200 mg/mL) cabotegravir , single-dose vial of 900 mg/3 mL (300 mg/mL) rilpivirin).
~For subsequent injections participants will be given CABENUVA 400-mg/600-mg Kit: (single-dose vial of 400 mg/2 mL (200 mg/mL) cabotegravir, single-dose vial of 600 mg/2 mL (300 mg/mL) rilpivirine)
~CABENUVA® is owned by or licensed to the ViiV Healthcare group of companies, GlaxoSmithKline Research Triangle Park, NC 27709"
15728326|NCT05037487|Drug|20 mg THC Cannabis|Smoked cannabis with THC
15727440|NCT05044962|Drug|Etonogestrel (ETG) implant|Contraceptive progestin implants are thin rods inserted under the skin of a woman's arm
15727441|NCT05044962|Drug|Intramuscular depo-medroxyprogesterone acetate (IM DMPA)|DMPA (150 mg of depo-medroxyprogesterone acetate (MPA)/ml IMI) is the most commonly used injectable contraceptive worldwide
15727442|NCT05044962|Drug|Levonorgestrel|Contraceptive estrogen implants are thin rods inserted under the skin of a woman's arm
15727443|NCT05044962|Drug|NNRTI, PI, or INSTI-containing 1st or 2nd line ART regimens|ART that concurrently contains combinations of non-nucleoside reverse transcriptase inhibitors (NNRTIs), such as efavirenz, and protease-inhibitors (PIs), such as atazanavir/ritonavir or lopinavir/ritonavir, or integrase inhibitors (INSTIs), such as raltegravir or dolutegravir
15727444|NCT05044949|Other|Probiotic|The study product is a probiotic strain
15727445|NCT05044949|Other|Placebo|The study product is a placebo to the probiotic strain
15727446|NCT05044936|Drug|Cannabidiol Oil|"The dose that will be used for each administration of CBD will be 0.5mg/kg of body mass. As there are no recommendations for CBD from the FDA or through previous research in humans, and especially for CBD cream, the dosage is based on the United Kingdom's governing body recommending maximal amounts of CBD ingestion being 1 mg/kg per day. Further, the practical amount that companies recommend is anywhere from a pea size to a handful, which can range from high and low amounts. Using 0.5mg/kg of body mass allows for a moderate use of the lotion, as well as leaving extra quantities throughout the day should people want to use CBD outside of their post-workout recovery strategies outside of a laboratory setting. To convert the amount of CBD to the amount of lotion, we will divide the amount of CBD (0.5 mg/kg) by 4.85 (the amount of mg of CBD per gram of lotion). This will calculate the amount (in grams) of lotion each participant will receive."
15727447|NCT05044936|Other|Resistance Exercise|Participants will complete eccentric-based leg press (4-s lowering phase and 1-s upward phase) for 10 sets of 8 repetitions at 70% 1RM in order to induce muscle damage using a leg press machine. Three minutes of rest will be permitted between sets. Following the 10th leg press, participants will complete 4 sets of 20 consecutive plyometric lunges using only their body weight. Two minutes of rest will be permitted between sets. The muscle damaging protocol will be done upon completion of the 4th set of plyometric lunges.
15727448|NCT05044923|Device|Targeted Epidural Spinal Stimulation|Two lead electrodes (Specify Surescan 5-6-5 Leads, Model 977C190 Medtronic) will be implanted epidurally over the dorsal aspect of the spinal cord through two laminotomies. Two implantable pulse generators (Intellis™ with AdaptiveStim™, Model 97715 Medtronic) will be connected to the lead electrodes and implanted in the upper buttocks of the participant.
15727449|NCT05044910|Dietary Supplement|Ready to Use supplementary food (RUSF)|Children with malnutrition will be given RUSF
15727450|NCT05044897|Drug|SI-B001|Administration by intravenous infusion.
15727453|NCT05044871|Drug|Pamiparib|40mg PO. bid.
15727454|NCT05044871|Drug|Bevacizumab|7.5mg/kg IV. D1 (q3w.)
15727455|NCT05044871|Drug|Tislelizumab|200mg IV. D1
15727456|NCT05044871|Drug|Nab paclitaxel|125mg / m2 IV. D1, 8 (q3w).
15727457|NCT05044871|Drug|Bevacizumab + Nab paclitaxel (intense dose-dense)|Bevacizumab 7.5mg/kg IV. D1, 15 (Q4w). + Nab paclitaxel 100mg / m2 IV. D1, 8, 15 (Q4w).
15727458|NCT05044858|Procedure|Midpoint transverse process block group|After marking the level of the incision by surgeon (commonly T5- T6) The patient will be situated in the lateral position, the block area will be sterilized with povidine-iodine, and high -frequency linear ultrasound probe will be placed oblique parasagittally 3 cm lateral to the spinous process at the level of skin incision. 100-mm short bevel echogenic needle (Contiplex, B.Braun, Germany) will be inserted in plane from cranial to caudal direction. The desired end point of the needle tip will be the midpoint of the line between the posterior border of transverse process and the pleura titrated bolus of 20 ml of 0.25% bupivacaine and dexamethazone 8 mg will be injected at the target site. At end of the surgery general anaesthesia will be stopped with reversal of muscle relaxation and awakening of patient
15727459|NCT05044858|Procedure|Sham group|"General anesthesia will be induced with the same protocol and MTP block will be done but with injection of placebo (2 ml normal saline) instead of local anesthetic .
~On arrival to the PACU postoperative Numerical Rating scale at rest and coughing will be recorded, analgesia will be maintained with intravenous paracetamol 1 g every 8 h and required additional rescue analgesia (morphine) at any time will be calculated."
15727461|NCT05044832|Behavioral|Personalized Music|Personalized music delivered during the perioperative and post-operative periods. Those assigned to the music group will receive music in the preoperative holding area as well as in the post-operative care unit.
15727462|NCT05044819|Drug|Cannabidiol|Oral Cannabidiol solution 100 mg/mL
15727554|NCT05043974|Other|Dry immersion|Subjects are immersed up to the neck for 5 days in a specially designed bath filled with tap water.
15727463|NCT05044806|Other|Ultrasound-guided remote ischemic conditioning|Before conducting RIC, Doppler ultrasound was used to measure the total occlusion pressure (TOP) of brachial artery, which was then determined as the cuff inflation pressure during RIC. The RIC program encompasses four main components of (1) three cycles of remote ischemic pre-conditioning which will be delivered right after the eligibility check and informed consent form signature before PCI; (2) one cycle of remote ischemic per-conditioning, which will be delivered during PCI; (3) three cycles of remote ischemic post-conditioning, which will be delivered within 10 min after PCI; and (4) two sessions per day of remote ischemic post-conditioning which will start on post-operative day 1 and last till hospital discharge. The remote ischemic pre- and post-conditioning share the RIC protocol, which comprises three 3 min cycles of RIC with 3 min intervals of reperfusion in between, while only one single 3 min cycle will be delivered for the remote ischemic per-conditioning.
15727464|NCT05044806|Other|Traditional remote ischemic conditioning|The RIC program encompasses four main components of (1)three cycles of remote ischemic pre-conditioning which will be delivered right after the eligibility check and informed consent form signature before PCI; (2)one cycle of remote ischemic per-conditioning, which will be delivered during PCI; (3)three cycles of remote ischemic post-conditioning, which will be delivered within 10 min after PCI; and (4) two sessions per day of remote ischemic post-conditioning which will start on post-operative day 1 and last till hospital discharge. The remote ischemic pre- and post-conditioning share the RIC protocol, which comprises three 3 min cycles of upper limb ischemia on the arm that is opposite to the PCI side with 3 min intervals of reperfusion in between delivered by an automated cuff inflation/deflation device, while only one single 3 min cycle will be delivered for the remote ischemic per-conditioning. The pressure applied during cuff inflation is 20 mmHg above systolic blood pressure.
15727465|NCT05044806|Procedure|Percutaneous coronary intervention|Percutaneous coronary intervention (PCI) will be performed by a cardiologist or doctor who specializes in the heart to open coronary arteries that are narrowed or blocked by the buildup of atherosclerotic plaque. PCI requires cardiac catheterization, which is the insertion of a catheter tube, and live x rays helping to guide the catheter into the heart to inject special contrast dye that will highlight the blockage. To open a blocked artery, another catheter will be inserted over a guidewire, a balloon will be inflated at the tip of that catheter, and a small mesh tube called a stent may be put in the artery to help keep the artery open. After PCI, the catheters will be removed, the opening on the wrist or groin will be closed and bandaged.
15727467|NCT05044767|Device|total hip arthroplasty|hip replacement surgery
15727468|NCT05044754|Procedure|Local treatment of the prostate (SCAP or HIFU)|Once the local involvement of the recurrent prostate cancer is confirmed, patient will undergo local treatment of the prostate (SCAP or HIFU)
15727469|NCT05044741|Procedure|Emergency surgical enterostomy|Emergency surgical enterostomy
15727470|NCT05044728|Drug|Anti-PD-1 antibody combined with Paclitaxel and carboplatin.|"Anti-PD-1 antibody, 240 mg, IV infusion for 30min (not less than 20min and not more than 60min), d1, every 3 weeks for total 2 cycles. Stratified regimen: group A, 24 hours after the end of chemotherapy; Group B will be given immunotherapy on the first day of each cycle.
~Paclitaxel, 135 mg/m2, IV, d1, q3w, for total 2 cycles. Carboplatin, AUC=5 (according to Calvert formula), IV, d1, every 3 weeks for a total of 2 cycles. Stratified regimen: group A, chemotherapy will be given on day 1 of each cycle; Group B will be given chemotherapy drugs 24 hours after the end of immunotherapy."
15727471|NCT05044728|Procedure|Surgical treatment stage|After the completion of neoadjuvant immunochemotherapy, patients will be tested again for the functional subsets of peripheral CD8 positive T cells. Alternative treatments will be sought for inoperable patients. For patients who are operable will receive minimally invasive or open surgery was performed 1 month after completion of neoadjuvant chemotherapy immunotherapy, and the functional subsets of peripheral CD8 positive T cells were detected again after surgery.
15727472|NCT05044715|Behavioral|Treatment as Usual|"Treatment as usual-TAU groups include:
~Mood Groups - General Process Groups
~Anxiety Groups - Cognitive Behavioral Therapy
~Body Image and Eating Concerns Groups
~Reconciling Faith and Sexuality Groups"
15727473|NCT05044715|Behavioral|Compassion-Focused Therapy (CFT)|The CFT protocol assumes that participants have no prior experience with meditation, mindfulness, and self-compassion and teaches principles of each as well as skills such as guided meditations.
15727474|NCT05044702|Other|Retro walking|Retro walking will be performed on treadmill for 15 min per day for 3 days per week for 4 weeks at self-paced speed.
15727475|NCT05044702|Other|conventional physical therapy|"hot pack for 10 mints and conventional exercise program Conventional physiotherapeutic exercise program which consist of exercises such as
~prone leg extension
~prone lying chest elevation
~prone extension with alternate arm and leg lift
~supine bridging, bridging with one leg lift Each exercise will be performed as 2 sets of 12 repetitions of each exercise, each exercise position maintained for 10 s, and a rest of 1 min between the sets will be perform. No external load/resistance will be provided for the exercises, and the participants will be perform the exercise within their available range of motion"
15727476|NCT05044689|Behavioral|Questionnaire|Questionnaire containing questions regarding diet, physical activity, past medical history and life style practices.
15727477|NCT05044689|Device|Bioimpedance/Body Composition Unit|Patients will provide information on body composition through the use of a bioimpedance machine which measures the body mass index, fat and total body water.
15727478|NCT05044676|Other|patients with hepatocellular carcinoma|The response of the hepatocellular carcinoma to treatment will be evaluated as part of the care
15727479|NCT05044663|Other|No intervention|This is an observational study
15727480|NCT05044650|Dietary Supplement|KOVIR hard capsule combined with background treatment|KOVIR is a hard capsule containing fine powder mixed medicinal herbs 600 mg
15727481|NCT05044637|Drug|Primaquine|7 days of unsupervised primaquine (3.5 mg/kg total dose) administered once per day (0.5 mg/kg OD).
15727482|NCT05044637|Drug|Primaquine|7 days of supervised primaquine (7.0 mg/kg total dose) administered once per day (1.0 mg/kg OD).
15727483|NCT05044637|Drug|Primaquine|14 days of unsupervised primaquine (7mg/kg total dose) administered once per day (0.5 mg/kg).
15727484|NCT05044624|Procedure|retroperitoneal mass excision|retroperitoneal mass excision
15727485|NCT05044611|Drug|Anhydrous Amiloride Hydrochloride|"Amiloride is a blocker of ENaC that is administered patients with various disorders, such as primary or secondary hyperaldosteronism. It does not have the market authorization in the indication of lithium-induced NDI.
~Dose : 5 mg Pharmaceutical form: Tablets Daily Posology : 10 mg Route of administration : oral Procedures and duration of treatment: 2 months during the double blinded phase and 10 additional months for the open label phase"
15727486|NCT05044611|Drug|Placebo|Route of administration : oral the control arm will receive a placebo twice daily during 2 months
15727487|NCT05044598|Device|RAFT-OS|RAFT-OS is an artificial tissue, populated with limbal epithelial cells and stromal cells.
15727488|NCT05044585|Other|Remote Automated Monitoring System|The subject will be monitored with conventional monitoring devices as well as the MultiSense patch.
15727489|NCT05044572|Other|Open chain kinetic exercises|Group A will perform open chain kinetic exercises Before the intervention all the participants will perform 20 minutes of warm up and 10 minutes of cool down. The Open kinematic chain exercises(Three sets of each exercise while one set of each exercise will be performed at the setup and remaining two sets will be guided to the patient as a home plan)-:Blackburn exercises ( 20 repetitions ) , Dynamic hug( 10 repetitions), W exercise(10 repetitions), lunges with dumbbells-forward(10 repetitions with half kg dumbbell), upward and diagonal, and Pectoralis minor stretching(3 to 5 stretches)will be performed
15727490|NCT05044572|Other|Forward head posture correction exercises|PatienGroup B participants will perform forward head correction exercise(22) Chin tuck Patient will Stand with upper back against a wall, feet shoulder-width apart. • Face forward, tuck your chin down, and pull head back until it meets the wall. • t
15727491|NCT05044559|Other|Continuous Positive Air Way Group|CPAP between 10 and 12 cmH2O
15727492|NCT05044559|Other|Control Group|"Day 1: Bed mobility chest physiotherapy, active assistive ROM 5 repetitions of upper and lower limb, ACBT cycle. ABGS was analyses at first minute of exercise and vital was record after exercise.
~Day 2: Active range of motion exercise progress with 5 repetitions bed to chair mobility. same exercise progress with 5 repetition and 5 minute walk( day 3rd ).walking time will increase with 10 min at 4 day and at 5th day stair climbing the ABGS was record in ICU 3 days."
15727493|NCT05044546|Behavioral|Behavioral Activation Therapy|Participate in BA counseling
15727494|NCT05044546|Procedure|Discussion|Participate in focus group
15727495|NCT05044546|Behavioral|Health Education|Participate in health and wellness education counseling
15727496|NCT05044546|Other|Questionnaire Administration|Ancillary studies
15727497|NCT05044546|Other|Tobacco Cessation Counseling|Participate in smoking cessation counseling
15727500|NCT05044494|Procedure|non-prompt surgery|
15727501|NCT05044481|Procedure|third molar surgical removal|ambulatory surgical intervention of the maxilla and / or mandible for third molar removal
15727502|NCT05044468|Drug|Lidocaine|Given via injection
15727503|NCT05044468|Drug|Liposomal Bupivacaine|Given via injection
15727504|NCT05044468|Other|Questionnaire Administration|Ancillary studies
15727505|NCT05044455|Behavioral|Cognitive Behavioural Therapy (CBT)|A 9 week CBT group, 2 hours weekly, is delivered by trained Peer Leaders to women randomized to this arm.
15727506|NCT05044442|Behavioral|moderate intensity continous training|Participants will complete 6 sessions of moderate intensity continous training during a 2 week intervention period. Participants will be asked to complete 30 minutes of continuous exercise.
15727507|NCT05044442|Behavioral|high intensity interval training|Participants will complete 6 sessions of high intensity interval training during a 2 week intervention period. The programme involves repeated 1 minute bouts of simple on the spot movements interspersed with 1 minute of rest.
15727508|NCT05044429|Drug|Intravenous Lidocaine|Patient will receive intravenous lidocaine 1.0-1.5 mg/kg/hour for 48 hours post-operatively in addition to standard of care (patient-controlled analgesia (PCA) pump)
15727509|NCT05044429|Drug|Transversus abdominis plane (TAP) block|Subject will receive 0.2% Ropivacaine at 6-10ml/hour through transversus abdominis plane (TAP) block for up to five days post-operatively in addition to standard of care (patient-controlled analgesia (PCA) pump)
15727510|NCT05044429|Drug|Quadratus Lumborum (QL) Block|Subject will receive 0.2% Ropivacaine at 6-10ml/hour through quadratus lumborum (QL) block for up to five days post-operatively in addition to standard of care (patient-controlled analgesia (PCA) pump)
15727511|NCT05044416|Device|VieScope|intubation with VieScope laryngoscope
15727512|NCT05044416|Device|Videolaryngoscopy|intubation with videolaryngoscope
15727513|NCT05044403|Procedure|Extracorporeal support with haemoperfusion|Use of extracorporeal support with haemoperfusion
15727514|NCT05044403|Procedure|Conventional treatment|Conventional treatment
15727515|NCT05044390|Procedure|Lung transplantation (single, lobar or bilateral lung transplantation)|Lung transplantation were performed for end-stage interstitial lung disease secondary to pleuroparenchymal fibroelastosis
15727516|NCT05044364|Drug|This is a randomized, single-blind, parallel-controlled clinical study with the original research clevidipine butyrate injection as the positive control drug, which is an equivalence test.|Patients with hypertensive emergency and hypertensive sub-emergency who are clinically diagnosed as unsuitable for oral antihypertensive treatment or oral antihypertensive treatment are ineffective, and require intravenous medication to quickly control their blood pressure. The qualified subjects will be randomly divided into groups according to the test protocol. The method of administration is to infuse clevidipine butyrate injection for emergency blood pressure reduction treatment to achieve rapid, effective and stable lowering of blood pressure to the target blood pressure, and prevent or reduce further damage to the target organ.
15727517|NCT05044351|Device|Fluobeam LX|See arm description
15727518|NCT05044351|Other|Conventional surgery without NIRAF assistance|Patients undergoing conventional thyroid lobectomy without NIRAF-assistance
15727552|NCT05044000|Device|Deep propioceptive stimulation|Participants will start using the blanket (of the arm name), 30 days wash-out and 15d with the other blanket
15727553|NCT05043987|Drug|CPO102|Anti-claudin 18.2 Antibody-MMAE Drug Conjugate
15727519|NCT05044338|Diagnostic Test|imaging|(1) Build the first full information big data cloud platform for diagnosis, treatment and clinical research of senile valvular disease in China (2) To establish a cohort of elderly patients with valvular disease in China and a complete database covering clinical information, functional, imaging evaluation, treatment and follow-up; (3) To analyze the clinical characteristics, functional status and imaging characteristics of senile valvular disease in China, and to understand the current situation of diagnosis and treatment; To establish a whole process standardized comprehensive evaluation system of clinical indicators of senile valvular disease combined with a variety of imaging for Chinese people.
15727522|NCT05044312|Other|Sleeping Disturbances|most common complaints of patients after surgery and may affect the ability to carry out daily activities, quality of life, and post-surgery recovery.
15727523|NCT05044299|Device|Isoped|Isoped is a mechanical device allowing movement of lower extremities in a forward and backward motion, with phone-based app to control resistance load
15727524|NCT05044286|Other|no intervention|no intervention
15727525|NCT05044273|Device|Synergy XD stent|Percutaneous coronary intervention with Synergy XD stent
15727526|NCT05044260|Procedure|Direct sinus lift with titanium reinforced PTFE membrane|Implants will be placed immediately after sinus lifting procedure and maintaining the sinus membrane in position using PTFE titanium reinforced membrane.
15727527|NCT05044247|Procedure|ESP blocks|ultrasound and fluoroscopy to identify the spread of drug
15727528|NCT05044234|Drug|Cedirogant|Capsule, Oral
15727529|NCT05044234|Drug|Placebo|Capsule, Oral
15727532|NCT05044208|Diagnostic Test|ECG monitoring|After clinical routine diagnostics an additional ambulatory ECG monitoring for 7 days is established
15727535|NCT05044182|Procedure|Decompression and drainage seton|Incision the internal sphincter over the fistula tract in intersphinteric space to achieve decompression then drainage seton will be put around external sphincter.
15727536|NCT05044182|Procedure|Cutting seton|Cutting seton is introduced from outside openning to internal openning and encircling the internal and external anal sphincter.
15727537|NCT05044169|Drug|Broncho-Vaxom|administration for 6 months after remmission
15727538|NCT05044156|Other|salivary sample|salivary sample
15727539|NCT05044143|Other|Monitoring the length of the uterine cervix using transvaginal ultrasound|Cervical length is measured with a 7-9 MHz transvaginal probe by trained obstetricians-gynecologists following the same standardized approach (Berghella 2003). Transvaginal CL measurement is largely used in current obstetric practice, and it is considered the 'gold standard' measurement when assessing the uterine cervix. In contrast to transabdominal US, the transvaginal approach is highly reproducible, and measurements are unaffected by maternal obesity, cervical position, and shadowing from fetal parts (Berghella 2003, Hassan 2000, ACOG 2012, Berghella 2012).
15727540|NCT05044130|Dietary Supplement|High-fat mixed-meal tolerance test (HF-MMTT)|The test meal consists of a standardized HF-MMTT (791 cal) with 197 g cream (38 % fat), 18 g sugar and 1 g vanilla sugar for taste (75 g fat, 25 g carbohydrate and 4 g protein)
15727542|NCT05044104|Device|Consumer-facing wearable smart watch|Wearable watch technology that has the ability to measure heart rate, respiratory rate, single-lead electrocardiography, and blood oxygen saturation.
15727543|NCT05044091|Drug|PARP inhibitor|Ovarian/fallopian tube/primary peritoneal cancer patients with PARP inhibitors according to the NCCN guideline and their instructions
15727544|NCT05044078|Other|Autogenic Inhibition MET|If a sub-maximal contraction of the muscle is followed by stretching of the same muscle it is known as Autogenic Inhibition MET.
15727545|NCT05044078|Other|Reciprocal Inhibition MET|If a submaximal contraction of a muscle is followed by stretching of the opposite muscle then this is known as Reciprocal Inhibition MET.
15727546|NCT05044065|Other|Physical exercise|The intervention group will receive an exercise program consisting of a combination of supervised and home-based exercise with a focus to induce metabolic stress during both a pre- and postoperative period consisting of a total of 5-6 weeks. Protein supplementation will be given to exclude insufficient intake.
15727547|NCT05044052|Behavioral|Emphasis on the Choosing Wisely Viral Prescription Pad|We will investigate the effects of emphasizing the use of materials developed by Choosing Wisely Canada (CWC) - namely the viral prescription pad - to help physicians act upon the feedback to reduce their prescribing.
15727548|NCT05044039|Drug|Duvelisib|Patients should take duvelisib at approximately the same time every day, with or without food.
15727549|NCT05044026|Other|Jakavi|Prospective observational study. There is no treatment allocation. Patients administered Jakavi by prescription and administered according to the SmPC.
15727550|NCT05044013|Other|Full access to JomPrEP app|All participants will receive the JomPrEP app with access to all of its features which include: customizable page (using avatars and pseudonyms); visual dashboard (track and visualize progress); HIV testing plan (create plan for HIV testing, order self-testing kits, testing site locator); PrEP Care Plan (PrEPxpress, automated reminders for follow-up care, labs, delivery); chat function and discussion forum; tailored messages and reminders; assessment center (weekly assessment on adherence to PrEP, HIV risk, mood); knowledge center (resources on HIV testing and PrEP); Mental health support (screen for P/SUD, counseling feedback, referral to support services); Integration of provider locator (provides users with a GPS enabled map for PrEP and mental health support providers in Malaysia) and Gamification (offers extrinsic motivation by rewarding points/milestones for doing activities within the app). Participants can also contact the RA using the chat function for support.
15727551|NCT05044013|Other|inactivated JomPrEP app|Only information and resources for PrEP services will be available along with access to risk assessment tools.
15729021|NCT05032144|Drug|Placebo|Intravenous injection
15727555|NCT05043961|Procedure|Palisade sacroiliac joint radiofrequency ablation using 3-tined needles|"Palisade-RF is performed using a conventional temperature-controlled RF generator generating monopolar lesions at 85°C for 150 sec, with a 30 sec ramp time. Four, 18 Gauge 3-tined, 90 mm cannulas with an active tip of 10 mm (RF Trident; Diros Technology) will be used along with a four-output radiofrequency generator configured for bipolar output.
~The RF energy is delivered, making two bipolar lesions at a time. This procedure is repeated at the remaining target sites by leapfroging the needles, until the entire length is lesioned.
~Lesioning the L5 dorsal ramus:
~o The RF needle is inserted at the inflexion between the ala of the sacrum and the S1 superior articular process. The RF energy is delivered, creating a monopolar lesion."
15727556|NCT05043948|Diagnostic Test|Blood samples|for evaluation of the genome-wide association study
15727557|NCT05043935|Procedure|L-PRF with antimicrobial photodynamic therapy|Application of L-PRF with antimicrobial photodynamic therapy in the defect
15727558|NCT05043935|Procedure|antimicrobial photodynamic therapy without L-PRF|application of antimicrobial photodynamic therapy without L-PRF in the defect
15727559|NCT05043922|Drug|CYH33|a Selective PI3Kα Inhibitor
15727560|NCT05043909|Behavioral|VR-based training|Students simulate the different physical and oral conditions of the elderly through virtual situations and provide suitable oral care methods. The whole training session took approximately two hours for each student; First, students were first given a short introduction to the VR system's use (10 minutes). Second, they were able to carry out oral care for the elderly while wearing VR goggles and using hand-controllers with the teaching and audio guides during the process (90 minutes), and an evaluation was taken after the intervention (20 minutes).
15727561|NCT05043896|Procedure|Li-ESWT|Li-ESWT twice weekly for 4 weeks
15727562|NCT05043896|Drug|Tadalafil 2.5Mg Tab|tadalafil 2.5mg once daily
15727564|NCT05043870|Drug|Infliximab and immunosuppressives|the infusion of IFX (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks, the immunomodulatory agent was azathioprine 1.5-2.5mg/kg per day or methotrexate 10-25 mg/m2 week
15727565|NCT05043870|Drug|Infliximab|the infusion of IFX (5mg/kg) were given at 0, 2, 6 weeks and then every 8 weeks
15727566|NCT05043857|Radiation|Stereotactic Body Radiotherapy (SBRT)|"Postoperative Stereotactic Body Radiation Therapy (SBRT) after tumor resection targeting 2 volumes
~CTV1 (clips+isotropic 5mm expansion, edited on anatomic barriers): receiving 40 Gy in 5 fractions of 8 Gy
~CTV2 (CTV1+ anisotropic 10-15 mm expansion including corresponding vessels, retroperitoneum posterior to the SMV/SMA or celiac axis, edited on anatomic barriers): receiving 30 Gy in 5 fractions of 6 Gy."
15727567|NCT05043844|Device|abdominal binder|Wearing an abdominal binder postoperatively
15727568|NCT05043831|Device|DSLT|Direct-SLT is applied via the limbus to the trabecular meshwork
15727569|NCT05043805|Drug|Dextromethorphan|add on therapy
15727570|NCT05043805|Other|placebo|add on therapy
15727571|NCT05043792|Drug|TT-00920|TT-00920 Tablets
15727572|NCT05043792|Drug|TT-00920 Placebo|TT-00920 Placebo Tablets
15727573|NCT05043779|Procedure|Awake Airway Nasoendoscopy|Preoperative Awake Airway Nasoendoscopy of upper airway
15727574|NCT05043766|Drug|PF614|PF614 is an oxycodone prodrug
15727575|NCT05043766|Drug|Naltrexone Hydrochloride|Naltrexone HCl tablets, 50 mg, will be used to block the opioid effects in healthy volunteers
15727576|NCT05043766|Drug|OxyContin|Bioequivalence single-dose comparison to OxyContin
15727577|NCT05043753|Other|Point of care ultrasound to measure the fetal abdominal circumference (POC-US-AC)|"Midwives perform a POC-US to measure the fetal abdominal circumference (AC) and evaluate the quantity of amniotic fluid.
~In order to identify the appropriate sonographic plane the following markers need to be identified on POC-US
~Fluid filled fetal stomach on the left.
~Umbilical vein
~Umbilical portion of left portal vein within liver, as it meets the pars transversa (horizontal portion of left portal vein) seen as a right sided  L  or  C  shape.
~Fetal spine seen in cross section Amniotic fluid volume will be evaluated determining the deepest vertical pocket (DVP). Measurement is performed by assessing a pocket of maximal depth of amniotic fluid free of umbilical cord and fetal parts. The transducer is held perpendicularly to the patient's abdomen. The absence of a pocket measuring at least 2 cm in depth and 1 cm in width is indicative of oligohydramnios, while detection of a pocket measuring 8 cm or larger is suggestive of polyhydramnios (ACOG bulletin 175, 2016)."
15727578|NCT05043740|Drug|Repatha or Praluent|Evolocumab (Repatha®) 140 mg or Alirocumab (Praluent) 75mg every two weeks, first subcutaneous injection at the time of randomization, followings during 12 months
15727579|NCT05043727|Combination Product|Exer gaming|exer gaming treatment plan will include perfect ten balance, wii skiing, wiicycling. Each Patient will receive twenty four sessions. Each treatment session was of 50 minutes with two minutes rest between each exercise.
15727580|NCT05043727|Combination Product|conventional treatment plan|it will receive conventional treatment plan which includes balance training, gait training, stretching and strengthening exercises.Each patient will receive twenty four sessions of conventional physical therapy. Treatment session will be of 50 minutes with 2 minutes rest period between each exercise.
15727581|NCT05043714|Biological|NG-641 in combination with Nivolumab|Patients will receive a first study treatment cycle consisting of one IV infusion of NG-641 on Days 1, 3 and 5 and one IV infusion of nivolumab on Day 15. Patients will then receive nivolumab monotherapy given once every four weeks on Day 15 of each 28-day cycle up to 8 cycles
15727582|NCT05043701|Drug|Personalized drug combination|A personalized drug combination will be prescribed to each patient based on the functional drug screen
15727583|NCT05043688|Drug|SHR-1210|The study perform preoperative neoadjuvant therapy, surgery and postoperative adjuvant therapy on subjects. Preoperative neoadjuvant therapy includes 3 groups: immunotherapy combined with neoadjuvant chemotherapy, immunotherapy combined with neoadjuvant radiochemotherapy, and neoadjuvant radiochemotherapy.
15727584|NCT05043675|Drug|[18F]APN-1607|Subjects will receive one injection of [18F]APN-1607 (0.1~0.15mCi/Kg), a PET radiopharmaceutical selective for fibrillar tau. [18F]APN-1607 injection will be followed by a 10 ml saline flush.
15727585|NCT05043662|Diagnostic Test|UroCAD assay, CTU examination and urine cytology|The extracted DNA from morning urine will be analyzed by UroCAD to determine the level of CNV. CTU and cytology will be performed according to the routine of clinical practice.
15727586|NCT05043649|Drug|Camsirubicin|The dose escalation of camsirubicin will start at 265 mg/m2, with dose increments of 50% until a Grade 2 non-hematologic toxicity is observed at which point subsequent dose escalations will be in increments of 25% until an MTD is identified in patients with ASTS.
15727587|NCT05043636|Device|Vagus|Cardiovascular autonomic neuropathy (Vagus) both resting heart rate variability and cardiovascular reflex tests The examination consists of 4 measures, all aimed at measuring heart rate. Measurements are taken for 5 minutes rest, change of position from lying to standing position, during deep breathing and by Valsalva (by breathing in a mouthpiece with a 40 mmHg resistance).
15727588|NCT05043636|Device|HeartsTrends|• Cardiovascular autonomic neuropathy (HeartTrends®) measurers 60-minutes heart rate variability via a chest belt electrode (a Holter monitor) and an external data acquisition device.
15727589|NCT05043636|Device|Sudoscan|Peripheral small-fiber sympathetic function (Sudoscan), measuring sudomotor function by electrochemical skin conductance in hands and feet
15727590|NCT05043636|Device|UllMeter|• Pressure pain sensitivity of the chest bone is recorded (with a device which has the size and shape as a pen)during rest as a measure for sympathetic autonomic activity of the brain (UllMeter®) (www.stressmeter.org)
15727591|NCT05043636|Device|DPN-check|Nerve conduction velocity and amplitude of the Sural nerves by DPN-check
15727592|NCT05043636|Device|Rolltemp|Cold and warm sense of foot and lower leg
15727593|NCT05043636|Device|Dexcom G6 Device|"Insertion of continuous glucose monitor ( The Dexcom G6 Device)
~After 10 days in the study the patient will return the glucose monitor and diary by prepaid mail.
~Glycemic variability and hypoglycemia duration will be calculated from CGM data. Glycemic variability will be assessed by standard deviation (SD) and Coefficient of Variance (CV). We define normo-glycemic range as sensor glucose between 4.0 and 10.0 mmol/L. Hypoglycemia will be defined in two ranges as SG ≤3.9 mmol/L or SG ≤3.0 mmol/L). An episode of hypoglycemia will be defined as at least 15 minutes with SG below 3.9 mmol/L or 3.0 mmol/L, respectively. CGM recordings with less than 72 hours of data will be excluded from analysis."
15727594|NCT05043623|Device|Rhinoswab Junior|To determine the sensitivity and specificity of the Rhinoswab compared to the standard CTDN swab, in detecting viruses on the respiratory panel
15727595|NCT05043610|Biological|Umbilical Cord-Derived Wharton's Jelly Mesenchymal Stem Cells (WJ-MSCs)|Cell Tech Pharmed Company (Tehran, Iran) will provide us with cGMP grade WJ-MSCs. 10^7 WJ-MSCs will be delivered through the intracoronary route. WJ-MSCs will be infused at a rate of 2.5 ml/min across three portions.
15727596|NCT05043610|Other|Conventional Treatment|Beta-blocker, angiotensin-converting enzyme (ACE) inhibitor, aldosterone antagonist, aspirin, ticagrelor, statin, and glyceryl trinitrate plus cardiac rehabilitation.
15727597|NCT05043597|Procedure|Thrombus aspiration|Thrombus aspiration
15727598|NCT05043584|Device|Fluobeam LX|See arm description
15727599|NCT05043571|Biological|CAR T-cell therapy|This is a single-centre, phase I study to determine the efficacy and safety of CAR T-cell therapy in patients with high-risk T-ALL, refractory or relapsed T-ALL.
15727600|NCT05043558|Drug|beprostaglandin sodium|beprostaglandin sodium
15727601|NCT05043532|Procedure|2 passes during EUS-guided fine needle biopsy|Once the pancreatic mass has been visualized on endoscopic ultrasound, a total of two passes will be performed and placed in 10% formalin for processing for molecular profiling. Onsite evaluation will be performed using a part of the sample from the first pass in order to establish onsite diagnostic adequacy in all patients.
15727602|NCT05043532|Procedure|3 passes during EUS-guided fine needle biopsy|Once the pancreatic mass has been visualized on endoscopic ultrasound, a total of three passes will be performed and placed in 10% formalin for processing for molecular profiling. Onsite evaluation will be performed using a part of the sample from the first pass in order to establish onsite diagnostic adequacy in all patients.
15727603|NCT05043519|Drug|FAM-NP41|The patients will be injected with FAM-NP41 in one dose intravenously 2 hours prior to the dural incision.
15727604|NCT05043506|Drug|Palbociclib + aromatase inhibitor|Palbociclib + an aromatase inhibitor therapy
15727605|NCT05043506|Drug|Aromatase inhibitor|Aromatase inhibitor monotherapy
15727606|NCT05043493|Procedure|Injection in the intraarticular space of glenohumeral joint|U/S guided injection of platelet rich plasma (PRP) or normal saline (NS)
15727607|NCT05043480|Device|PEMF|Participants will receive pulsed electromagnetic fields (PEMF) exposure to alternate lower limbs weekly for 16 weeks. Participants will place alternate lower limb into the PEMF machine. Each lower limb will be exposed to 1.5mT magnetic field exposure for 10 mins once a week (total 10 min each week) for 16 weeks.
15727608|NCT05043467|Drug|Duvie(Lobeglitazone) tab 0.5mg|patients with type 2 diabetes who received lobeglitazone 0.5mg for more than one year between February 1, 2014 and December 20, 2018
15727609|NCT05043454|Other|High Intensity Interval Training (HIIT) Exercise|Participants will exercise 4 days/week for 10 weeks using the High Intensity Interval Training (HIIT) protocol. Sessions can be conducted at home or at a gym with access to a cycle ergometer. Participants will undergo 2 supervised training sessions to learn the HIIT protocol. To record heart rate, session duration, and time at each exercise intensity, participants will be provided with an H10 Polar TM heart rate chest strap monitor and a Polar Beat/Polar Flow account. Participants will download the Polar Beat/Flow smart phone application to record exercise sessions and allow the researcher to conduct remote data monitoring. Research staff will contact participants twice per week to provide feedback.
15727610|NCT05043441|Behavioral|Acceptance and commitment therapy (ACT)|Caregivers assigned to this intervention group will receive individual ACT sessions guided by a trained coach for one hour per week over 10 weeks through Zoom videoconferencing with psychoeducation materials provided.
15727611|NCT05043441|Behavioral|Psychoeducation|The psychoeducation control group will receive care as usual with psychoeducation materials provided.
15727612|NCT05043428|Behavioral|The roles of peers and functional tasks in enhancing exercise training for adults with COPD: a pilot randomized controlled trial|An 8 week two-arm pilot randomized control trial aimed to evaluate the effects of an online exercise and peer support intervention for people living with COPD.
15727613|NCT05043415|Procedure|Immediate endoscopic necrosectomy|In the immediate endoscopic necrosectomy group, endoscopic ultrasound-guided drainage of the necrotic collection is performed using a lumen-apposing metal stent, immediately followed by endoscopic necrosectomy. Endoscopic necrosectomy involves removal of infected necrotic pancreatic tissue via the cystogastrostomy/cystoenterostomy tract using a variety of endoscopic accessories.
15727614|NCT05043415|Procedure|Step-up endoscopic interventions|In the step-up endoscopic interventions group, endoscopic ultrasound-guided drainage of the necrotic collection is performed using a lumen-apposing metal stent. Endoscopic necrosectomy is not performed during the index drainage session, but is performed at a later time as needed.
15727615|NCT05043402|Drug|navicixizumab|navicixizumab IV
15727616|NCT05043402|Device|Xerna™ TME Panel|RNA-seq-based biomarker platform that classifies any given patient tumor sample into phenotypes based on the dominant biology of the tumor microenvironment (TME).
15727617|NCT05043389|Other|myofunctional therapy program|Exercise oral cavity muscle
15727618|NCT05043376|Drug|Standard of care|Standard COVID-19 care as per the hospital guidelines
15727619|NCT05043376|Dietary Supplement|BLIS K12|Daily 2 oral BLIS K12 tablets for up to 14 days.
15727620|NCT05043363|Device|LumenEye X1 digital rectoscope|The LumenEye X1 is a novel digital rectoscope that introduces digital HD imaging and improved ergonomics to conventional rigid sigmoidoscopy.
15727621|NCT05043350|Drug|Loratadine|107 patients will receive standard pharmacotherapy according to the treatment protocols of the National Committee of COVID-19 in addition to oral famotidine 40 mg twice daily (Manufactured by AMOUN Pharmaceutical Company) until the day of discharge + LORATIDINE (Manufactured by AMOUN Pharmaceutical Company)Oral: 10 mg once daily.
15727622|NCT05043350|Drug|Famotidine|107 patients will receive standard pharmacotherapy according to the treatment protocols of the National Committee of COVID-19 in addition to oral famotidine 40 mg twice daily (Manufactured by AMOUN Pharmaceutical Company) until the day of discharge + LORATIDINE (Manufactured by AMOUN Pharmaceutical Company)Oral: 10 mg once daily.
15727623|NCT05043337|Behavioral|Maternal voice|"The recordings were made in a quiet and separate consultation room. For infants in the maternal voice group, mothers were recorded what they wanted to say to their baby and read an independently published children's book, Xiao Qi's yellow persimmon which describes how mothers with premature babies care for their infants. After reviewing the quality of the recordings, the maternal voice recordings were edited for 13 minutes using a sound organizer. Respiration, heart rate, oxygen saturation, and Neonatal Infant Pain Scale (NIPS) were measured and recorded 3 minutes before, during, 1 minute, 3 minutes, and 10 minutes after the puncture."
15727624|NCT05043337|Behavioral|Lullaby|The Brahms Lullaby recordings are compiled for 13 minutes. Measuring with the Respiration, heart rate, oxygen saturation, and neonatal infant pain scale (NIPS ) were recorded 3 minutes before, during, 1st, 3rd, and 10th minutes after the heel lance puncture.
15727625|NCT05043337|Behavioral|Maternal voice combined with lullaby|"The recordings were made in a quiet and separate consultation room. For infants in the  Maternal voice combined with lullaby group,  mothers were recorded what they wanted to say to their baby and read an independently published children's book-Xiao Qi's yellow persimmon , and giving mother listening to the Brahms Lullaby at the same time, the maternal voice recordings were edited for 13 minutes using a sound organizer. Measuring with the Respiration, heart rate, oxygen saturation, and neonatal infant pain scale (NIPS ) were recorded 3 minutes before, during, 1st, 3rd, and 10th minutes after the heel lance puncture."
15727626|NCT05043324|Drug|AntiCov-220|The daily maintenance, AntiCov-220 dose is to take 3 times a day, 1 tablet each time.
15727627|NCT05043311|Biological|SCTV01C|intramucular injetion
15727628|NCT05043311|Other|Placebo|intramucular injetion
15727629|NCT05043298|Drug|IBI 360 Injection|IBI 360 dose level of escalation IV Q3W Day 1
15727630|NCT05043285|Biological|SCTV01C|intramucular injetion
15727631|NCT05043285|Other|Placebo|Intramuscular injection
15727632|NCT05043272|Biological|SARS-COV-2 VACCINE|The antibody titer and adverse reactions were observed.
15727633|NCT05043259|Biological|inactive SARS-CoV-2 vaccine (Vero cell)|This vaccine contains 600 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research & Development Co., Ltd. 0.5 ml / bottle.
15727634|NCT05043259|Biological|Low dose aerosolized Ad5-nCoV|This vaccine is produced by CanSino Biologics Inc. It is a liquid dosage form, 0.1 ml / dose, contains 1×10^10 virus particles of recombinant replication defective human type 5 adenovirus expressing SARS-CoV-2 S protein, aerosol inhalation.
15727635|NCT05043259|Biological|High dose aerosolized Ad5-nCoV|This vaccine is produced by CanSino Biologics Inc. It is a liquid dosage form, 0.2 ml / dose, contains 2×10^10 virus particles of recombinant replication defective human type 5 adenovirus expressing SARS-CoV-2 S protein, aerosol inhalation.
15727636|NCT05043246|Biological|SARS-COV-2 VACCINE|the antibody titer and adverse reactions were observed.
15727637|NCT05043233|Drug|Methimazole(MMI)|Methimazole is a widely used antithyroid drug and is often used in the treatment of Graves' disease hyperthyroidism
15727638|NCT05043220|Device|PPG and PROM|description will follow
15727639|NCT05043207|Diagnostic Test|uAud|Patients will receive hearing aid treatment based on an audiometry obtained with an user-operated automated audiometry procedure
15727640|NCT05043207|Diagnostic Test|Traditional audiometry|Patients will receive hearing aid treatment based on an audiometry obtained with an traditional audiometry procedure
15727641|NCT05043194|Drug|Ursodeoxycholic Acid 250 Mg Oral Capsule|prevention
15727642|NCT05043181|Biological|Low Density Lipoprotein Receptor mRNA Exosomes|"The study consists of two phases: dose escalation phase and extension phase. Dose escalation phase：For the intervention of low-density lipoprotein receptor mRNA (LDLR mRNA) exosomes. A total of six dose groups are planned, with single dose of 0.044 mg/kg, 0.088 mg/kg, 0.145 mg/kg, 0.220 mg/kg, 0.295 mg/kg and 0.394 mg/kg, respectively. About 3 subjects are enrolled in each dose group. In the 0.044 mg/kg group, the second and third subjects are required to start exosome infusion treatment after the treatment of the previous subjects, and the other dose groups are not required to do this. There are three treatments in total, and the interval between each exosome treatment is 7±1 d.
~Extension phase: About 12 subjects are further enrolled. The subjects will receive 3 intravenous/peritoneal infusion treatment of LDLR mRNA exosomes once a week for three weeks, whose single dose is determined in the dose escalation phase."
15727737|NCT05042375|Drug|camrelizumab + famitinib|Camrelizumab for injection, 200 mg; Famitinib malate capsules, 20 mg.
15727643|NCT05043142|Diagnostic Test|ELISA test for the antibodies to COVID-2019.|Each subject will be assigned an individual number, which will be used for conduction of a rapid ELISA test for the antibodies to COVID-2019. Subjects will be notified of the test results.
15727644|NCT05043129|Biological|Biological/Vaccine: SARS-COV-2 VACCINE|The antibody titer and adverse reactions were observed.
15727645|NCT05043116|Dietary Supplement|Cholecalciferol D3|2000 IU of Vitamin D provided as oral suspension for one year
15727646|NCT05043116|Other|Oral placebo suspension|Oral suspension with no active substance tasting like the active supplement.
15727647|NCT05043103|Combination Product|Lecigon® based on European Medicines Agency (EMA) SmPC|There might be different brand names in other countries
15727648|NCT05043090|Drug|savolitinib|Tablets : 3 × 200 mg tablets once daily
15727649|NCT05043090|Drug|durvalumab|Concentrate for solution for IV infusion : 1500 mg durvalumab every 4 weeks
15727650|NCT05043090|Drug|sunitinib|Capsules : 2 x 25mg capsules once daily 4 weeks on, 2 weeks off
15727653|NCT05043064|Procedure|Wet lab tasks|Robotic-assisted internal thoracic artery harvesting, mitral annulus sutures placement and atrial closure in porcine model
15727654|NCT05043051|Device|Vagal stimulation|Vagal stimulation
15727655|NCT05043051|Device|Sham stimulation|Sham vagal stimulation
15727656|NCT05043025|Other|Identification of the cricothyroid membrane|The cricothyroid membrane is identified using a laryngeal handshake technique in different patient positions.
15727657|NCT05043012|Device|flexible AIR coil|mpMRI scan
15727658|NCT05043012|Device|endorectal coi|mpMRI scan
15727659|NCT05042999|Device|Oculus Go Virtual Reality Goggles|Oculus Go is a standalone portable Virtual Reality device that enables the user to immerse in different virtual environments. Non pharmacological technique to reduce pain and anxiety during a procedure.
15727660|NCT05042986|Drug|.[14C]-SKI-O-703|Single oral dose of 200 mg (100 μCi in 200 mg salt [0.5 μCi/mg as salt], equivalent to 100 μCi in 142 mg active [0.7 μCi/mg as active]) of [14C]-SKI-O-703 containing approximately 100 μCi of [14C]-SKI-O-703 per capsule after an overnight fast.
15727661|NCT05042973|Drug|Empagliflozin 10 MG|Patients are randomized 1:1 to receive either Empagliflozin or matching placebo for 180 days
15727662|NCT05042973|Drug|Placebo|Placebo matches the active drug in appearance, odor and labelling.
15727663|NCT05042960|Other|Brightness|Changing the colors or brightness on the device (computer screen) for one month
15727664|NCT05042947|Device|double-loop clips|a new ligation method using the double-loop clips (D-L clips) technique
15727665|NCT05042947|Device|Titanium Clip|the Titanium Clip
15727666|NCT05042934|Procedure|Fine-Needle Aspiration|Undergo fine-needle aspiration
15727667|NCT05042934|Drug|Irinotecan|Given IV
15727668|NCT05042934|Drug|Irinotecan Hydrochloride|Given IV
15727669|NCT05042934|Drug|Lurbinectedin|Given IV
15727670|NCT05042908|Drug|LBL-003Injection|LBL-003 was given every two weeks for treatment
15727671|NCT05042895|Procedure|Group A|"Office diagnostic hysteroscopy for assessment of the following:
~cervical canal: arborvitae, mucous, any abnormal pathology like a polyp.
~Endometrium cavity: vascularity, thickness, color, gland openings, any abnormal pathology.
~Darwishhysterscopic triad: shape, caliber, depth, abnormal pathology, flow patency, bubble flow patency, and peristalsis.
~Endometrial sample by a Novak's curette Histopathologic assessment: will be sent for the routine out-patient Pathology lab to comment on the endometrial pattern and abnormalities.
~Physical and laboratory examinations follicle-stimulating hormone [FSH], LH, thyroid-stimulating hormone [TSH], prolactin, and pre ovulatory LH LH levels of the patients will be measured on day 3 of the menstrual cycle."
15727672|NCT05042895|Procedure|Group B|"Office diagnostic hysteroscopy for assessment of the following:
~cervical canal: arborvitae, mucous, any abnormal pathology like a polyp.
~Endometrium cavity: vascularity, thickness, color, gland openings, any abnormal pathology.
~Darwishhysterscopic triad: shape, caliber, depth, abnormal pathology, flow patency, bubble flow patency, and peristalsis.
~Endometrial sample by a Novak's curette Histopathologic assessment: will be sent for the routine out-patient Pathology lab to comment on the endometrial pattern and abnormalities.
~Physical and laboratory examinations follicle-stimulating hormone [FSH], LH, thyroid-stimulating hormone [TSH], prolactin, and pre ovulatory LH LH levels of the patients will be measured on day 3 of the menstrual cycle."
15727673|NCT05042882|Dietary Supplement|Early enteral nutrition|Enteral nutrition via nasojejunal tube
15727674|NCT05042856|Procedure|PanOptix IOL implantation|All the patients will be bilaterally implanted with PanOptix IOL，one eye will be randomized selected for monocular analysis of each patient.
15727675|NCT05042830|Procedure|Blood sampling|Blood samples will be taken by puncture of the antecubital vein for PBMCs isolation, cytokines measurement, and flow cytometry analysis
15727676|NCT05042830|Procedure|Nasal biopsies|Nasal biopsies will be taken from the lower fringe of the inferior turbinate, approximately 1-2cm from the anterior curved edge for RNA sequencing and confocal microscopy staining
15727677|NCT05042830|Biological|Nasal specimen collection|Nasal specimen collection will be conducted. Nasosorption FXi/PU (containing a synthetic absorptive matrix (SAM)) will be obtained.
15727678|NCT05042830|Procedure|Mucosal RNA sampling|A 10 cm nasal curette will be used (Rhino-Probe, Arlington Scientific, USA). The curette is brought to lie against the mid-inferior portion of the inferior turbinate under direct visualisation. The curette is rubbed against the mucosal surface, going outwards. To ensure successful sample acquisition, this motion will be repeated 2-3 times
15727679|NCT05042830|Procedure|Intranasal challenge|The extract of birch pollen (Allergopharma, Vienna, Austria) will be freshly diluted in a 0.9 percent sterile sodium chloride solution and administered by means of a metered pump. The allergen will be administered supplying 15 μl per puff to both nostrils. Azelastine nasal spray or desloratadin 5mg will be given if the patient suffers from nasal or eye symptoms after the challenge. Equivalent amount of saline without allergens will be given to the control group.
15727738|NCT05042375|Drug|pembrolizumab|pembrolizumab 200 mg.
15727739|NCT05042375|Drug|camrelizumab|Camrelizumab for injection, 200 mg.
15727740|NCT05042362|Drug|Elinzanetant (BAY3427080)|120 mg elinzanetant orally once daily
15727680|NCT05042830|Procedure|Skin prick test|"In order to evaluate the patient's sensitization profile at the screening visit, a regular skin prick test will be conducted with commercial birch pollen extract and a panel of allergens used in routine diagnosis in the allergy clinic of the ENT department.
~Titrated skin prick test: Titrated SPT to birch pollen extract is conducted by using increasing dilutions up to 1:100 000. As a result, it is possible to determine the lowest concentration that leads in a skin reaction."
15727681|NCT05042830|Procedure|Peak Nasal Inspiratory Flow (PNIF)|The functionality and convenience of the PNIF presents a rare opportunity to rapidly obtain objective measurements of nasal peak inspiratory flow. It was also validated during other nasal allergen challenge as a study tool
15727682|NCT05042830|Biological|Pregnancy test|In female patients, a regular urine pregnancy test will rule out pregnancy. The test will be conducted at the screening visit before the first skin prick test and then once a month afterwards.
15727683|NCT05042817|Drug|Morphine|The effect of iintrathecal morphine on the vesical function after a caesarean section
15727684|NCT05042817|Drug|NaCl 0.9%|NaCl 0.9%
15727685|NCT05042817|Drug|50 mg prilocaine + 2.5 mcg sufentanil|50 mg prilocaine + 2.5 mcg sufentanil
15727686|NCT05042804|Other|Machine learning models predicting postoperative death and acute kidney injury|The machine learning display uses data from the electronic health record to predict the likelihood of postoperative death and postoperative acute kidney injury.
15727687|NCT05042791|Combination Product|radiation combined with pyrotinib and capecitabine|This study selects different radiation (SRT or WBRT) combined with pyrotinib and capecitabine to treat HER2-positive advanced breast cancer patients with brain metastases
15727688|NCT05042778|Other|Auriculotherapy|A licensed acupuncturist (holder of civil liability insurance) with more than nine years of experience with this technique will apply auriculotherapy. Indwelling fixed semipermanent needles embedded in a skin-coloured adhesive tape will be used at the actives auricular points around the vagus nerve area.
15727689|NCT05042765|Other|self-reported entheogen use|self-reported participation in therapy or a retreat in a naturalistic setting that incorporated the use of entheogens in the past five (5) years
15727690|NCT05042752|Procedure|CLINICAL ULTRASOUND|The intervention group will receive the standard care of treatment in AHF and the performance of CU.
15727691|NCT05042739|Diagnostic Test|CAARMS;SIPS; BSABS;|Comprehensive Assessment of At Risk Mental State (CAARMS); Structured Interview for Psychosis-Risk Syndrome (SIPS); Bonn Scale for the Assessment of Basic Symptoms (BSABS);
15727692|NCT05042726|Device|cTBS First|"cTBS: At 30 Hz, the stimulation intensity was 80% resting motor threshold (RMT), and the duration was 33.2 s as a group of stimulation with 600 stimulation pulses. Two groups of stimulation were repeated in each cerebellar hemisphere with an interval of 5 min in each group.
~Pseudo-stimulation: The operation system has built-in program pseudo-stimulation and other parameters are same as cTBS.
~The first course of treatment, participants are treated with cTBS for 2 weeks, a total of 10 times, then followed up for 8 weeks. The first course of treatment, participants are treated with pseudo-stimulation for 2 weeks, a total of 10 times, then followed up for 8 weeks."
15727693|NCT05042726|Device|Pseudo-stimulation First|"cTBS: At 30 Hz, the stimulation intensity was 80% resting motor threshold (RMT), and the duration was 33.2 s as a group of stimulation with 600 stimulation pulses. Two groups of stimulation were repeated in each cerebellar hemisphere with an interval of 5 min in each group.
~Pseudo-stimulation: The operation system has built-in program pseudo-stimulation and other parameters are same as cTBS.
~The first course of treatment, participants are treated with pseudo-stimulation for 2 weeks, a total of 10 times, then followed up for 8 weeks. The first course of treatment, participants are treated with cTBS for 2 weeks, a total of 10 times, then followed up for 8 weeks."
15727694|NCT05042713|Other|WaveOne Gold, One Curve, OneFlare|During the endodontic treatment of molar teeth diagnosed with irreversible pulpitis, the effect on postoperative pain when single file systems with rotational (OneCurve) and reciprocal (WaveOne Gold) kinematics are used with and without coronal flaring instrument (OneFlare) will be compared.
15727695|NCT05042700|Drug|Melatonin|Enema with 25 mg melatonin
15727696|NCT05042700|Drug|Placebo|Enema without melatonin
15727697|NCT05042687|Drug|Tc99m sestamibi|Given by IV
15727698|NCT05042674|Dietary Supplement|Placebo|after a blood draw placebo will be consumed followed by 2 additional blood draws
15727699|NCT05042674|Dietary Supplement|Ergothioneine, 25 miligrams|after a blood draw 25 miligrams of ergothioneine will be consumed followed be 2 additional blood draws
15727700|NCT05042674|Dietary Supplement|Ergothioneine, 25 miligrams, daily for 1 week|a blood draw will be administered after a week of consuming 25mg ergothioneine daily
15727701|NCT05042661|Device|acupuncture-like transcutaneous electrical nerve stimulation|The intervention group performed Al-TENS therapy 3 times a week for at least 20 minutes each time for 4 consecutive weeks. The second, fourth, and eighth week after the intervention.
15727702|NCT05042648|Drug|Buprenorphine patch|Group B will receive buprenorphine patch of 10 mg (sustained release of 10 µg/h) applied either on chest or on outer side of arm 12 h before surgery. The transdermal buprenorphine patch should be applied to intact skin on the flat surfaces of the upper outer arm, upper chest, upper back, or the side of the chest. The skin should be dry, clean, non irritated, non hairy (hair should be trimmed with scissors, not shaved), and without large scars.
15727703|NCT05042635|Drug|Ixekizumab+Jueyin Granules|"Ixekizumab：160mg was injected subcutaneously at week 0 (80mg twice), then 80mg at week 2 and 4 (once).
~Jueyin Granules：Put each bag of daily dose into the same container, pour about 50ml warm water into it, stir until the particles are basically dissolved, then add proper amount of boiling water to dilute it, take it warm in two times."
15727704|NCT05042635|Drug|Ixekizumab+Jueyin placebo Granules|"Ixekizumab：160mg was injected subcutaneously at week 0 (80mg twice), then 80mg at week 2 and 4 (once).
~Jueyin placebo Granules：Put each bag of daily dose into the same container, pour about 50ml warm water into it, stir until the particles are basically dissolved, then add proper amount of boiling water to dilute it, take it warm in two times."
15727705|NCT05042622|Device|Cytokine adsorber filter|• Intervention group #1 a cytokine adsorber will be used (30 patients): patients on ECMO - subgroup A; septic patients - subgroup B.
15727706|NCT05042622|Device|Extracorporeal hemoperfusion cartridge|• Intervention group #2 an extracorporeal hemoperfusion cartridge will be used (30 patients): patients on ECMO - subgroup C, septic patients - subgroup D.
15727710|NCT05042570|Other|Instrument Assisted Soft Tissue Mobilization|"This technique will be performed using instruments of different sizes, shapes and treatment styles.
~During the application, instruments will be applied to loosen the muscle tissue and fascia by gliding on the tissue at certain angles.
~The muscle groups to be treated with IASTM are gastrocnemius, soleus and tibialis posterior. It will also be applied to the superficial and deep fascia.
~The instrument will be sterilized before treatment.
~IASTM treatment will be applied without damaging the tissue after massaging cream is applied to the muscle fibers with the instrument."
15727711|NCT05042570|Other|Stretching Exercises|"The muscle groups to be applied stretching exercises are gastrocinemius, soleus and tibialis posterior. It will also be applied to the superficial and deep fascia.
~3 different functional stretching exercises will be applied;
~With the hands supported on the wall and with the help of the physiotherapist, the affected extremity is behind the knee in full extension m. gastrocnemius stretching exercise,
~With the hands supported on the wall and with the help of the physiotherapist, the knee is partially flexed, with the affected extremity behind. soleus stretching exercise,
~It is a stretching exercise that will be applied by asking the patient to squat without lifting his heels, with the patient's hands supported by the physiotherapist."
15727712|NCT05042570|Other|Control Group / NDT program|"Efforts to eliminate tone disorders,
~Sensory-perception-motor integrity development studies,
~Activities aimed at facilitating movements in daily life,
~Stretching and strengthening exercises due to muscle shortness and weakness,
~Studies to increase lower and upper extremity functionality,
~It will include the training of activities such as standing up, walking and balance."
15727713|NCT05042544|Diagnostic Test|Point-of-Care Testing|Participants will be offered finger-stick point-of-care testing for HCV
15727714|NCT05042531|Drug|Azacitidine|Azacitidine, 75mg/m2,d1-7;Treatment cycles every 28 days
15727715|NCT05042531|Drug|Dasatinib|dasatinib,20mg,po,qd,treatment cycles every 28 days
15727716|NCT05042518|Behavioral|Experiment|breathing control and self-talk with objectives
15727717|NCT05042518|Other|Control|The participant in the control group will receive consultations by a sport psychologist for goal setting and positive thinking. The duration is similar to the training group (4-5 minutes in each session, 4 sessions per week for 1 month)
15727718|NCT05042505|Drug|Dapagliflozin 10Mg Tab|Dapa group (n = 50): Patients with diabetes mellitus will receive Dapagliflozin 10 mg
15727719|NCT05042505|Drug|Sitagliptin 100mg|Sita group (n = 50): Patients with diabetes mellitus will receive sitagliptin 100 mg once daily
15727720|NCT05042492|Device|gekoTM|The gekoTM device is a small, transcutaneous nerve stimulator that is placed non-invasively on the skin, whereby the surface electrodes will be attached close to the peroneal nerve. Activation of the peroneal nerve causes contraction of the calf muscle pump, which will increase blood circulation that corresponds to 60% of walking. The increased blood circulation reduces the pressure difference between capillaries and the surrounding tissue and transfers the tissue fluid back into the veins and lymph fibers
15727721|NCT05042479|Other|Usual distraction and pain prevention techniques.|"For the first painful procedure, the child will benefit usual distraction and pain prevention techniques.Pain prevention and management techniques commonly used in the conduct of care:
~Application of a patch or anaesthetic cream 1 hour before the treatment
~Vigilant sedation using a premedication for lumbar punctures: Midazolam /Nalbuphine/Hydroxyzine/Morphine.
~Apart from care using VR, MEOPA can be given to the child for all assessed care on prescription.
~Apart from care using VR, the usual distraction techniques are left to the patient's choice (electronic tablet, smartphone, games, songs...)
~The presence of the parents"
15727722|NCT05042479|Other|Virtual reality|For the 2nd painful procedure, the child will use a VR (virtual reality) headset as well as pain prevention techniques (excluding oxygen-nitrous oxide mixtures). The child will choose the application he/she wishes to use according to his/her age.
15727723|NCT05042479|Other|Choice between usual distraction or virtual reality|"For the 3rd painful procedure, the child will choose his/her favorite technique between :
~Usual distraction and pain prevention techniques or virtual reality"
15727724|NCT05042466|Drug|Trauma|1 gram, every other day, 8 week trial
15727725|NCT05042453|Device|Splentis® POP Tissue Anchoring System|Anterior cervicopexy with bilateral sacrospinous ligament fixation using Splentis
15727726|NCT05042440|Drug|Efanesoctocog alfa|Solution for injection Intravenous
15727727|NCT05042440|Drug|Octocog alfa|Solution for injection Intravenous
15727728|NCT05042440|Drug|Rurioctocog alfa pegol|Solution for injection Intravenous
15727729|NCT05042427|Other|Pregnancy Weight Management Health Literacy Questionnaire|Give questionnaires to check the weight management health literacy level of primigravida women.
15727730|NCT05042414|Behavioral|High intensity interval training|Four times four minutes treadmill interval training
15727731|NCT05042414|Behavioral|Moderate intensity training|Moderate intensity treadmill training
15727732|NCT05042414|Behavioral|Resting|No training
15727733|NCT05042401|Drug|SHR-1703|SHR-1703 75 mg Q4W
15727734|NCT05042401|Drug|SHR-1703|SHR-1703 150 mg Q4W
15727735|NCT05042388|Behavioral|Mindfulness-Based Relapse Prevention - Rolling Admission (MBRP-RA)|Integrates evidenced-based practices to decrease the probability and severity of relapse for those in addiction recovery. MBRP incorporates components from CBT relapse prevention and includes training in meditation practices as a means to foster increased awareness of emotional and cognitive experiences. MBRP also includes training in brief informal meditations aimed at increasing awareness and adaptive response to drug cues and negative affect.
15727736|NCT05042388|Behavioral|Treatment-As-Usual|Standard treatment programming procedures for all individuals residing within the residential treatment program. Includes: supportive group therapy; Narcotics Anonymous/12-Step Programming; music, art, and animal therapy; psycho-education on general issues related to mental health and SUDs; and medication counseling.
15727741|NCT05042362|Drug|Placebo|Matching placebo orally once daily
15727742|NCT05042336|Drug|camrelizumab/lenvatinib combined with TACE|"Lenvatinib 4mg qd body weight≤60,8mg；body weight>60,12mg
~Camrelizumab 200mg q2w/q3w"
15727743|NCT05042323|Behavioral|TF-CBT-Short|Participants receive either 4-5 sessions of TF-CBT-Skills or TF-CBT-Narr. If the participant still has significant PTSS they are provided with step two which is the components provided in the arm they did not receive.
15727746|NCT05042297|Procedure|Combined posterior and anterior ring fixation: Active comparator. Isolated posterior ring fixation: Experimental intervention|Reduction of the posterior ring was either closed reduction in SI joint dislocations & fracture-dislocations and sacral fractures or open reduction in iliac wing fractures through the lateral window of the ilioinguinal approach. Anterior pelvic ring reduction and fixation in the combined APR fixation group was done via the classic Pfannenstiel approach or extension more lateral & completing the anterior intrapelvic approach. Fixation was via pubic rami plating.
15727747|NCT05042284|Drug|Non-enteric coated pancreatic enzyme preparation|The patients will be given a non-enteric coated pancreatic enzyme capsule containing 30000 U of protease thrice daily along with meals for 3 months.
15727748|NCT05042271|Drug|meropenem|each patient received a 1 hour infusion of a single dose of 1 g of meropenem diluted in 100 ml of normal saline solution, at the same time as the start of the first TPE and meropenem PK studies were carried out after the administration of meropenem. Blood samples (3 ml) were obtained by direct venipuncture at the following times: shortly before (time zero) and 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 6 and 8 hours after the start of the meropenem administration.
15727749|NCT05042258|Drug|Dupilumab|12 week dupilumab administration
15727750|NCT05042245|Drug|Ornithine aspartate granule|Ornithine aspartate granules in the experimental arm.
15727751|NCT05042245|Drug|Silymarin capsule|Silymarin capsules in the active comparator arm.
15727752|NCT05042245|Drug|Silymarin capsule simulant|Silymarin capsule simulant in the experimental arm.
15727753|NCT05042245|Drug|Ornithine aspartate granule simulant|Ornithine aspartate granule simulant in the active comparator arm.
15727754|NCT05042232|Other|SARS-CoV-2 Positive|Participants who have tested positive for SARS-CoV-2, both with and without symptoms
15727755|NCT05042232|Other|SARS-CoV-2 Negative|Participants who have tested negative for SARS-CoV-2
15727756|NCT05042219|Diagnostic Test|Cardiac MRI|Cardiac MRI and Echocardiography before treatment initiation of pulmonary disease and 3 months thereafter
15727758|NCT05042193|Other|SARS-CoV-2|Observational
15727759|NCT05042180|Behavioral|Virtual Reality Cognitive Behavioral Therapy (CRAVR)|Participants in the intervention group will scheduled for 14 treatment sessions based on manualized cognitive behavioral therapy assisted with alcohol-related high risk situations in virtual reality. VR-assisted gradual exposure therapy is integrated as a part of CBT. I.e. VR scenes are used in CBT to induce craving for coping strategy skill training and cognitive analysis.
15727760|NCT05042180|Behavioral|CBT|The active comparator receives 14 conventional cognitive behavioral therapy sessions with
15727761|NCT05042167|Other|Resistance exercise|4 total resistance exercises that target all major muscle groups.
15727762|NCT05042154|Device|WatchPAT|The WatchPAT One can detect the presence of OSA based on measurement of peripheral arterial tone (PAT), pulse rate, oxygen saturation, actigraphy, snoring, and body position.
15727765|NCT05042128|Drug|CEND-1|CEND-1 is a novel cyclic tumour-penetrating peptide iRGD (internalizing Arginylglycylaspartic acid) which may overcome poor drug delivery by activation of a complex trans-tissue transport pathway, providing an opportunity to overcome this mechanism of resistance in PDAC
15727766|NCT05042128|Drug|Gemcitabine Injection|Chemotherapy drug provided as solution to be administered via IV infusion.
15727767|NCT05042128|Drug|Nab paclitaxel|Chemotherapy drug provided as solution to be administered via IV infusion.
15727768|NCT05042115|Other|Education in pain neurosciences and clinical hypnosis|Will be performed education in pain neurosciences and clinical hypnosis, in 4 sessions during 4 weeks
15727769|NCT05042115|Other|Education in pain neurosciences and clinical hypnosis plus osteopathic manipulative treatment|Will be performed education in pain neurosciences and clinical hypnosis, and only for this group will be delivered osteopathic manipulative treatment, in 4 sessions during 4 weeks
15727770|NCT05042102|Combination Product|Donepezil + Cognitive remediation therapy (CRT)|Subjects in this arm will receive (1) donepezil and (2) cognitive remediation therapy (CRT). Subjects will take 5 mg/day of oral donepezil in the evening for the first 4 weeks, then 10 mg/day of oral donepezil in the evening until week 13.
15727771|NCT05042102|Combination Product|Donepezil + Placebo CRT|Subjects in this arm will receive (1) donepezil and (2) placebo CRT. Subjects will take 5 mg/day of oral donepezil in the evening for the first 4 weeks, then 10 mg/day of oral donepezil in the evening until week 13.
15727772|NCT05042102|Combination Product|Placebo medication + Cognitive remediation therapy (CRT)|Subjects in this arm will receive (1) placebo medication and (2) cognitive remediation therapy (CRT). Subjects will take placebo oral medication in the evening for the first 4 weeks, then placebo oral medication in the evening until week 13.
15727773|NCT05042102|Combination Product|Placebo medication + Placebo CRT|Subjects in this arm will receive (1) placebo medication and (2) placebo CRT. Subjects will take placebo oral medication in the evening for the first 4 weeks, then placebo oral medication in the evening until week 13.
15727774|NCT05042089|Other|No intervention will be applied.|The preoperative imaging of the participants, who were grouped according to the postoperative pathology results, will be examined.
15727775|NCT05042076|Drug|BK-specific T cells from Donor Lymphocytes|"Naturally occurring, allogeneic donor lymphocytes derived from a leukapheresis, enriched for BK-specific CD4+ and CD8+ T cells
~Suspension of BK-specific T cells in approximately 7 mL (5-10 mL range for volume of IMP) of 0.9% NaCl with 2.5% HSA at a cell dose of: ≥ 300 and ≤ 5,000 BK virus-specific CD3+ T cells/kg body weight (BW).
~IV bolus injection; IV push of IMP over approximately 2-4 minutes, resulting in an infusion rate of approximately 3 mL/min."
15728399|NCT05037006|Drug|TIVA - Neostigmine 50|Neostigmine 50 mcg/kg and atropine 25 mcg/kg when TOFc 3
15727776|NCT05042063|Device|Hyfe Cough Tracker|"Hyfe Cough Tracker is a digital acoustic surveillance system that uses an artificial intelligence system to discriminate cough from non-cough sounds. Hyfe is an AI-enabled mobile app that records short snippets (<0.5 seconds) of putative cough explosive sounds and then classifies them as cough or non-cough using a convolutional neural network (CNN) model. Briefly, the acoustic characteristics of recorded sounds are converted into an image file, which is then processed by an algorithm trained to identify graphical differences in images. This creates an adjustable prediction score, with values above it, resulting in a sound being classified as cough, and those below being classified as non-cough."
15727777|NCT05042050|Behavioral|A-iMAPS|Imagery therapy targeting Psychosis-Related PTSD
15727778|NCT05042037|Dietary Supplement|(Microbial cell preparation) probiotics|Lactobacillus acidophilus (107mg), Lactobacillus casei subsp (107mg), Lactobacillus lactis (107mg), Bifidobacterium bifidum (107mg), Bifidobacterium infantis (107mg) and Bifidobacterium longum (107mg)
15727779|NCT05042037|Other|Placebo|Placebo sachet with no microbial cell preparation
15727780|NCT05042024|Procedure|Scaling and root planing|Conventional periodontal therapy, non-surgical periodontal therapy
15727781|NCT05042024|Drug|Oral L-arginine aspartate administration|The use of L-arginine aspartate as adjuncts to local conservative treatment (scaling and root planing) of periodontitis to optimize treatment by modulating local macrophage subpopulations
15727782|NCT05042024|Drug|Oral L-ornithine aspartate administration|The use of L-ornithine aspartate as adjuncts to local conservative treatment (scaling and root planing) of periodontitis to optimize treatment by modulating local macrophage subpopulations
15727783|NCT05041998|Device|Trans-femoral prosthetic socket|"Unmodified) A custom-made check socket serving as the interface between residual limb and prosthesis
~Soft socket (Socket made from softer material than unmodified original)
~Stiff socket (Socket made from stiffer material than unmodified original)
~moderately lower brim height (Brim of the socket is lowered by 10% of socket length compared to unmodified original)
~slightly lower brim height (Brim of the socket is lowered by 5% of socket length compared to unmodified original)
~Oversized socket (The socket volume is 6% larger than the unmodified original)
~Undersized socket (The socket volume is 6% smaller than the unmodified original)
~CAT-CAM influenced geometry (The cross sectional geometry of the socket is modelled following the contoured adducted trochanteric-controlled alignment method (CAT-CAM))
~MAS influenced geometry (The cross sectional geometry of the socket is modelled following the Marlo Anatomic Socket (MAS) template)"
15727784|NCT05041985|Drug|Diazepam Tablets|Diazepam 5 mg tablet once per day (bedtime) for 7 days
15727785|NCT05041972|Drug|ARX788|ARX788 will be administered by intravenous (IV) infusion every 4 weeks (Q4W).
15727786|NCT05041959|Other|Smoking Abstinence|Participants will abstain from smoking for 24 hours
15727787|NCT05041959|Other|Ad Lib Smoking|Participants will continue smoking as usual (i.e. ad lib) in the day leading up to the scan and smoke one cigarette of their own brand immediately prior to scanning.
15727788|NCT05041946|Drug|Methylphenidate|Given PO
15727789|NCT05041946|Other|Placebo (Sugar Pill)|Given PO
15727790|NCT05041933|Drug|outsourcing of chemotherapy to Hospital at Home|outsourcing of chemotherapy to Hospital at Home
15727791|NCT05041920|Drug|famitinib、omeprazole|famitinib malate, 25 mg on study day 1; omeprazole, 40 mg, qd on study day 10-14, 16-22; famotine malate together with omeprazole, on study day 15.
15727792|NCT05041907|Drug|Favipiravir|Favipiravir 1800mg BD D0 and 800mg BD for a further 6/7.
15727793|NCT05041907|Drug|Monoclonal antibodies|Monoclonal antibodies: 1,200mg casirivimab/ 1,200mg imdevimab given once on D0
15727794|NCT05041907|Drug|Ivermectin|Ivermectin 600micrograms/kg/day for 7/7.
15727795|NCT05041907|Other|No treatment|No treatment (except antipyretics- paracetamol)
15727796|NCT05041907|Drug|Remdesivir|Remdesivir 200mg D0 and 100mg for a further 4/7.
15727797|NCT05041894|Other|tilt table|The tilt table provides passive standing for the stroke patients with tracheotomy
15727798|NCT05041881|Device|Trifocal lens AT LISA TRI, Zeiss|lens is made of hydrophilic acrylic material with square edge technology and having diffractive optic design
15727799|NCT05041881|Device|Accommodating Tetraflex HD lens, Lenstec inc.|lens is made of hydrophilic acrylic material with square edge technology and having monofocal optic design
15727800|NCT05041881|Device|Monofocal lens, Softec HD|lens is made of hydrophilic acrylic material with square edge technology and having monofocal optic design
15727801|NCT05041868|Other|Treatment|After a physical therapy evaluation, the patient underwent a booklet-guided physical exercise program that lasted three months (3 times per week with a duration of 60 minutes per session). Activities included overall stretching and strengthening (flexion, extension, adduction and abduction movements) and muscular endurance exercises (exercises involving open and closed kinetic chains), along with aerobic conditioning using a functional circuit. The patient was evaluated at 2 different timepoints (baseline and after treatment). The physiotherapist contacted the patient by phone weekly to follow the progression of the treatment.
15727802|NCT05041855|Behavioral|The Healthy Living Program/La Vida Saludable|A whole-family group childhood obesity intervention delivered at community recreation centers
15727803|NCT05041855|Behavioral|Recommended Treatment of Obesity in Primary Care|A healthy lifestyle counseling protocol that enhances usual primary care
15727804|NCT05041842|Drug|Tucatinib|300 mg orally twice daily
15727805|NCT05041842|Drug|Pertuzumab|Initial loading: 840 mg Maintenance: 420 mg, 3-weekly
15727806|NCT05041842|Drug|Trastuzumab|Initial loading: 8 mg/kg Maintenance: 6 mg/kg, 3-weekly
15727807|NCT05041842|Drug|Hormone therapy|Anastrozole (1 mg/day) or letrozole (2.5 mg/day) or fulvestrant (2x250 mg at day 1 and day 15 then every 4 weeks after the first injection)
15727808|NCT05041829|Other|Dietary sodium|Low sodium diet with sodium of <2.3 g/day (<100 mmol/day) and high sodium diet with sodium of ≥4 - <6 g/day (≥174 - <261 mmo/day)
15727809|NCT05041816|Device|Focal vibration therapy|Myovolt delivers vibration with a frequency between 60-300 Hz, and acceleration force between 1.8g to 19.1g peak to peak. Myovolt intensity will be set to ~up to 2X the participant's initial Myovolt perception threshold (however, the maximum intensity will be limited to 19.1g which is the maximum intensity the device can deliver). If the stimulation does not feel strong, the participant will be asked to manually increase the intensity until it feels strong but comfortable.
15729677|NCT05027048|Drug|Calcium chloride|See arm description above
15727811|NCT05041790|Drug|Choline Alfoscerate|Choline Alfoscerate 400mg per oral 3 times a day during the entire treatment period.
15727812|NCT05041790|Drug|Placebo|Placebo of Choline Alfoscerate 400mg per oral 3 times a day during the entire treatment period.
15727813|NCT05041777|Device|Optical Coherence Tomography|OCT is an imaging technique, which is able to produce real-time, in vivo, cross-sectional images of lesions with a depth of 1,5-2 mm. OCT imaging is based on light-interferometry, calculating the interference of an optical beam reflected by the tissue with a reference. [2] In such ways, microscopic details of lesions and tissues can be visualized. This information could be used to identify a lesion as BCC, and further specify the subtype. Therefore, the use of the OCT can reduce the number of biopsies and the accompanying morbidity.
15727814|NCT05041764|Other|NO INTERVENTION|No INTERVENTION
15727815|NCT05041751|Procedure|Acupuncture Point Injection|Receive trigger point injections
15727816|NCT05041751|Procedure|Massage Therapy|Perform myofascial release
15727817|NCT05041751|Other|Quality-of-Life Assessment|Ancillary studies
15727818|NCT05041751|Other|Questionnaire Administration|Ancillary studies
15727819|NCT05041738|Procedure|Intraoral Cryotherapy|small ice packs wrapped in sterile gauze placed in the mouth on the vestibular surface of the treated tooth
15727820|NCT05041738|Procedure|Intracanal Cryotherapy|Intracanal cryotherapy technique using 2.5°C cold saline irrigation as final irrigant
15727821|NCT05041725|Drug|Remimazolam Injection [Byfavo]|Remimazolam injection and continuous infusion for postoperative sedation, 0.2 mg/kg for 1 min and continuous infusion of 1-2 mg/kg/hour
15727822|NCT05041699|Combination Product|IPM Ring-105|DPV-LNG Ring containing xx mg of dapivirine + xx mg of levonorgestrel
15727823|NCT05041699|Combination Product|IPM Ring-106|DPV-LNG Ring containing xx mg of dapivirine + xx mg of levonorgestrel
15727824|NCT05041686|Combination Product|CADISS® System|"The CADISS® device was procured from AuXin Surgery. It consists in three elements:
~A single use disposable Remote Kit, containing a sterile cartridge, which prepares the Drug Product immediately before use, and the sterile tubing for fluid connexion. The Drug Product is a 30 ml sterile 5% mesna solution of pH 7.3+/-0.5 2.
~Reusable stainless steel noncutting mechanical instruments similar to those used in the normal practice, except for the provision of an internal irrigation channel bringing the Drug Product at the working edge.
~A pedal controlled electric motor driving the peristaltic cassette included in the disposable tubing in order to control the dispensing of the Drug Product during the procedure."
15727825|NCT05041673|Drug|Metformin|Antidiabetic drugs
15727826|NCT05041660|Other|Virtual-reality-based training|Uses virtual reality for the inhibitory control training, rather than a relatively simplistic computerized training.
15727827|NCT05041660|Other|Inhibitory Control Training|"Uses an active inhibitory control training which includes a stop signal."
15727828|NCT05041660|Other|Sham Inhibitory Control Training|"Uses an inhibitory control training which does not include a stop signal."
15727829|NCT05041660|Other|Computerized training|Uses a relatively simplistic computerized training.
15727830|NCT05041647|Drug|25:1 CBD/THC|"1 dose (1 mL) of HIGH CBD
~50 mg/ml CBD and 2 mg/ ml THC"
15727831|NCT05041647|Drug|5:1 CBD/THC|"1 dose (1 mL) of LOW CBD
~10 mg/ml CBD and 2 mg/ ml THC"
15727832|NCT05041647|Other|Placebo|"1 dose (1 mL) of PLACEBO
~No active ingredients"
15727833|NCT05041634|Behavioral|IHOPE|Integrating Healthy Habits Optimized by Community Participation and Engagled Learning
15727834|NCT05041621|Device|Sensor augmented MDI therapy plus mobile application|"Participants will use the mobile application to calculate their basal dose and to calculate their meal bolus dose by entering their glucose value, carbs (if applicable), fat composition (high fat or not), and type and timing of postprandial exercises. Participants will receive their dosing parameters weekly upon adjustments made by the reinforcement learning algorithm. Participants will be contacted by telephone on Weeks 1, 3, 5, and 7 in case of any technical difficulties or questions.
~All participants will be asked to complete the:
~(i) Diabetes treatment satisfaction questionnaire (DTSQ) and hypoglycemia fear survey-II (HFS-II) at baseline, halfway through the intervention, and post-intervention.
~(ii) mHealth usability questionnaire (MAUQ) at post-intervention."
15727835|NCT05041608|Procedure|Endoscopic Surgery|These procedures include: POEM (Peroral Endoscopic Myotomy) for Achalasia, G-POEM (Gastric Peroral Endoscopic Myotomy) for gastric outlet obstruction, Z-POEM (Peroral endoscopic myotomy for Zenker's Diverticulum), EMR (Endoscopic Mucosal Resection), ESD (Endoscopic submucosal dissection), STER (Submucosal tunneling endoscopic resection), NOTES (Natural Orifice Translumenal Endoscopic Surgery), TIF (Transoral Incisionless Fundoplication), Endoscopic Fistula Closure, Endoscopic Suturing, Capsule Endoscopy and EFTR (Endoscopic full-thickness resection).
15727836|NCT05041595|Diagnostic Test|Lyme diagnostic assay|Serological and immunoresponse assay
15727837|NCT05041582|Device|tDCS|dual tDCS with ipsilesional primary motor cortex (M1) anodal stimulation and contralesional M1 cathodal stimulation, 2 weeks after SSRI treatment
15727838|NCT05041582|Drug|Citalopram|total 3 months, since 2-4 weeks after stroke
15727839|NCT05041582|Behavioral|Rehabilitation|hospitalized rehabilitation, 3 hours daily
15727840|NCT05041569|Other|MRI sequences|perform additional sequences added by research
15727841|NCT05041556|Other|Case-control study of clinical outcomes|A case-control questionnaire will be administered at the home of cases and controls
15727842|NCT05041556|Other|Case-control study of mortality outcome|A case-control questionnaire will be administered at the home of cases and controls
15727843|NCT05041543|Drug|NTX-101|Eye drops, topical administration
15727844|NCT05041543|Drug|Placebo|Placebo as eye drops
15727845|NCT05041517|Behavioral|BOLT + PTC|BOLT is a Brief Online Training (BOLT) for Measurement-Based Care (MBC). Participants in the BOLT condition were subsequently randomized into varying amounts of post-training consultation (PTC).
15727846|NCT05041504|Behavioral|Peer navigation|Participants in the intervention group will receive ongoing support from a trained peer navigator for 3 months after completing treatment for prostate cancer via the True North Peer Navigation website. Participants will be matched with a trained peer navigator who assesses needs and barriers to care, provides practical, informational, and emotional support, and empowers them to take a proactive role in their health. Participants will also have access to a health resource library on the True North Peer Navigation website that contains local and national resources about prostate cancer.
15728400|NCT05037006|Drug|TIVA - Neostigmine 70|Neostigmine 70 mcg/kg and atropine 35 mcg/kg when TOFc 3
15727847|NCT05041504|Other|Active wait list control|Participants in the active wait list control group will receive usual care and access to a health resource library on the True North Peer Navigation website that contains local and national resources about prostate cancer. After completion of the study, patients in the active wait list control group will be matched with a peer navigator.
15727848|NCT05041491|Behavioral|BREAK|The BREAK intervention is a physical activity regimen.
15727849|NCT05041491|Behavioral|ONE|The ONE intervention is a physical activity regimen.
15727850|NCT05041478|Procedure|Cold Snare Endoscopic mucosal resection with adjuvant snare tip soft coagulation|Use of injected chromogelofusine solution to raise a lesion prior to polypectomy. Lesion then removed with a stiff thin-wired snare. Following this defect margins are treated with electrocautery to create a rim of ablated tissue.
15727851|NCT05041478|Procedure|Cold Snare Endoscopic Mucosal Resection|Use of injected chromogelofusine solution to raise a lesion prior to polypectomy. Lesion then removed with a stiff thin-wired snare.
15727852|NCT05041465|Other|Clay mask|Clay mask powders- French green, Rhassul and bentonite
15727853|NCT05041452|Diagnostic Test|Cardiac magnetic resonance scan|Multiparametric cardiac magnetic resonance, including functional and structural parameters
15727854|NCT05041439|Behavioral|Community Health Worker|Participants will receive 5 one-on-one sessions with a CHW over 6 months.
15727855|NCT05041426|Drug|Letermovir|Participants who are CMV R+ will receive LET prophylaxis for 6 months, and participants who are CMV D+/R- will receive LET prophylaxis for 12 months. The duration of prophylaxis is per current standard of care. LET will be administered at a dose of 480 mg IV or oral once daily. IV administration will occur only for those patients unable to swallow tablets. If LET is co-administered with cyclosporin A (CsA), the dosage of LET should be decreased to 240 mg once daily. All patients will be followed for 12 weeks after completion of LET for the occurrence of CMV infection or disease after prophylaxis. Participants on this protocol will receive acyclovir 400 mg orally BID for the duration of LET therapy for herpes simplex virus and varicella zoster virus prophylaxis.
15727856|NCT05041426|Drug|Valganciclovir|Historical controls will have received CMV prophylaxis with valganciclovir for 6 months for CMV R+ and for 12 months for CMV D+/R-.
15727857|NCT05041413|Behavioral|Moms Quit|Participants will receive text messages tailored on (1) current smoking status and (2) intention to quit/remain quit. Message content includes supportive messaging for child and self-care, relapse prevention, and smoking cessation. Women who are ready to quit will receive messages from the SmokeFreeText library.
15727858|NCT05041413|Behavioral|Text4Baby|Text4Baby is a free, publicly available text messaging program that provides information about nutrition, safe sleep tips, baby's milestones, signs and symptoms of labor, doctor visit and appointment reminders, breastfeeding advice, car seat safety, information on health insurance, urgent health alerts, and resource hotlines and websites.
15727859|NCT05041400|Other|Evaluation of the strength of knee flexors and extensors|Each participant will benefit from a clinical evaluation and an evaluation of the strength of knee flexors and extensors using an isokinetic dynamometer after a 10-minute warm up.
15727860|NCT05041361|Behavioral|Cognitive Behavioral Therapy (CBT)|Cognitive Behavioral Therapy (CBT) is a behavioral (psychotherapeutic) intervention for major depressive disorder (MDD). A highly trained masters' or PhD-level clinician will administer 8 weekly CBT sessions (~50 minutes each), following the standard cognitive behavioral therapy for depression protocol.
15727861|NCT05041361|Device|Whole-Body Hyperthermia (WBH)|Whole-body hyperthermia (WBH) will be administered by trained research assistants. Preparation for the WBH, the WBH session, and cool down will last 2.5 hours, with active WBH lasting up to approximately 80 minutes. WBH will take place in an infrared sauna dome, and the active heating phase will last until the participants has achieved a core (rectal) temperature of 101.3 F.
15727862|NCT05041348|Diagnostic Test|handgrip strength;physical function|low muscle strength diagnostic cutoffs of handgrip <28.0 kg for men and <18.0 kg for women.Functional disability studies define slowness as 6-m walk <1.0 m/s.
15727863|NCT05041335|Other|wet heparinzed suction|Needle flushed with 5000 Units in 10mL of heparin
15727864|NCT05041335|Other|Microsieve|A microsieve used for tissue preparation
15727865|NCT05041335|Other|No heparin flush|The needle not prepped
15727866|NCT05041335|Other|No microsieve|The tissue is placed into formalin
15727867|NCT05041322|Drug|Buspirone|Subjects take 30 mg buspirone HCl (15 mg twice a day) for 14 Days.
15727868|NCT05041322|Drug|Placebo|Subjects take Placebo pills (twice a day) for 14 Days.
15727869|NCT05041309|Biological|Axicabtagene Ciloleucel|A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously
15727870|NCT05041309|Biological|Brexucabtagene Autoleucel (KTE-X19)|A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously
15727871|NCT05041296|Diagnostic Test|Cardiac magnetic resonance scan|Multiparametric cardiac magnetic resonance including traditional and quantitative functional and structural parameters
15727872|NCT05041283|Other|Chatbot|A artificial-intelligence based chatbot is provided 3 days before colonoscopy to answer questions concerning bowel preparation and colonoscopy conduct.
15727873|NCT05041283|Other|Phone call|A phone call is performed every day starting at 3 days before colonoscopy to support bowel preparation.
15727874|NCT05041270|Drug|normal saline|"Surgery will be started under spinal anesthesia. When sensory block regress to T12 dermatome Epidural bolus dose will be given epidural bolus dose of 12ml (10ml 0.25% bupivacaine + 2ml normal saline) The onset of sensory blockade injected epiduraly with maximal cephalic spread will be assessed by bilateral pinprick method along the midclavicular line, every 5 min for 30 min and then every 30 min.
~top up dose of 8ml will be given postoperative (6ml 0.25% bupivacaine + 2ml normal saline)."
15727875|NCT05041270|Drug|Dexmedetomidine|"Surgery will be started under spinal anesthesia. When sensory block regress to T12 dermatome Epidural bolus dose will be given epidural bolus dose of 12ml (10ml 0.25% bupivacaine + 100µg dexmedetomidine in 2ml volume) The onset of sensory blockade injected epiduraly with maximal cephalic spread will be assessed by bilateral pinprick method along the midclavicular line, every 5 min for 30 min and then every 30 min.
~top up dose of 8ml will be given postoperative (6ml 0.25% bupivacaine + 20µg dexmedetomidine in 2ml volume)."
15727906|NCT05041010|Drug|Neu2000KWL group|1st infusion of 750mg in patients receiving endovascular therapy within 12 hours following ischemic stroke onset followed by 9 consecutive infusions of 500 mg at intervals of 12 ± 1 hours, twice a day.
15727876|NCT05041270|Drug|Nalbuphine|"Surgery will be started under spinal anesthesia. When sensory block regress to T12 dermatome Epidural bolus dose will be given epidural bolus dose of 12ml (10ml 0.25% bupivacaine + 10mg nalbuphine in 2ml volume) The onset of sensory blockade injected epiduraly with maximal cephalic spread will be assessed by bilateral pinprick method along the midclavicular line, every 5 min for 30 min and then every 30 min.
~top up dose of 8ml will be given postoperative (6ml 0.25% bupivacaine + 2mg nalbuphine in 2ml volume)."
15727877|NCT05041257|Drug|Mirvetuximab soravtansine|Administered by intravenous (IV) infusion on Day 1 of every 3-week cycle
15727878|NCT05041244|Device|Negative pressure wound therapy delivered through VAC|Initial cycle: Continuous first 48 hours Subsequent cycle: Consider intermittent DPC (5 min ON/2 mins OFF) for rest of the therapy Target Target Pressure: 50-175mmHg, to be titrated for more drainage Dressing change interval: every week; need for more frequent dressing need to be evaluated. More frequent change of adaptic can be considered. (Adaptic is a layer of thin dressing that will be in direct contact with the wound to reduce the risk of maceration and adherence to the dressing)
15727879|NCT05041244|Device|Standard of care|"Participants in the control arm will have their dressings changed as per the current standard of care.
~Effective management of DFU will depend on accurate diagnosis and assessment and appropriate debridement of non-viable tissues in patients from both arms Patients will be advised to continue off loading and any evidence of early infection should be promptly treated."
15727880|NCT05041231|Device|Photobiomodulation therapy (PBT)|"Any invasive procedures will be done. The treatment in question will be done by a device that looks like a bracelet, which is placed on the hand/fingers to emit light/laser and does not cause pain or temperature change. There will be 8 photobiomodulation sessions, 2 per week, 10 minutes each session.
~The dosimetric parameters of the therapy will be carried out in a standardized and personalized way, with programming of the light and all the necessary information so that the device can carry out the application of the treatment application of electromagnetic waves in the red and infrared spectral range 660-1000 nm)."
15727881|NCT05041231|Device|Sham Photobiomodulation therapy (Sham PBT)|Similar to active PBT, however, the device will not provide the active electromagnetic waves)
15727882|NCT05041218|Other|Neural Interfaces Electroencephalogram measurement on Operators|Electroencephalogram based neural interfaces acquired during the interventional procedure and during alpha attenuation protocols (AAP) and psychometric questionnaires. AAP and psychometrics are acquired at the beginning of the shift, before and after each procedure performed.
15727883|NCT05041205|Dietary Supplement|Beauty drink powder|Beauty drink powder is designed as a oral beauty product to provide benefits to skin
15727884|NCT05041205|Device|Cosmetic apparatus|This device is designed to let participants to experience brighter, softer, smoother skin and an energizing facial massage. A synergestic effect when combine with beauty drink powder is expected.
15727885|NCT05041192|Dietary Supplement|Synaquell|15.8 grams of Synaquell are mixed with 10 ounces of water two times per day and consumed.
15727886|NCT05041192|Dietary Supplement|Placebo|15.8 grams of a placebo (that looks, smells, and tastes like Synaquell) are mixed with 10 ounces of water two times per day and consumed.
15727887|NCT05041179|Dietary Supplement|Pruvin R|Combination of N-acetylcysteine an glycine
15727888|NCT05041179|Other|Isomaltulose|Placebo as comparator to intervention
15727889|NCT05041166|Drug|Hyperpolarized [13C] Pyruvate|Will be injected at a dosage of 0.43 ± 0.05 mL/kg body weight
15727890|NCT05041153|Drug|Lenvatinib|Given by PO
15727891|NCT05041153|Biological|Pembrolizumab|Given by IV
15727892|NCT05041140|Device|29-XeMRI imaging|129-XeMRI scan
15727893|NCT05041127|Biological|Cetuximab|Given IV
15727894|NCT05041127|Other|Questionnaire Administration|Ancillary studies
15727895|NCT05041114|Device|Motor Neuroprosthesis|Type of implantable brain computer interface
15727896|NCT05041101|Drug|Eribulin Mesylate|Given IV
15727897|NCT05041101|Drug|Grapiprant|Given PO
15727898|NCT05041088|Dietary Supplement|ProdromeNeuro Plasmalogen|The product being investigated in this study is the ProdromeNeuro Omega 3 oil nutritional supplement. This product contains naturally occurring fatty acids in higher concentrations than similar products that are commercially available. The purpose of this research study is to better understand the effects of ProdromeNeuro Omega-3 nutritional supplementation among participants with age-related cognitive decline.
15727899|NCT05041075|Device|Weighted Blanket|Weighted blankets provide Deep Pressure Stimulation (DPS) or Deep Touch Pressure (DTP) which has advantages in both physical and psychological domains.
15727900|NCT05041062|Drug|Nivolumab|Nivolumab is an immunotherapy drug (a type of drug that helps your immune system firght cancer) that is often used with ipilimumab as the first treatment in adults with mesothelioma whose disease cannot be removed by surgery. The drug will be given as an IV infusion.
15727901|NCT05041062|Drug|Ipilimumab|Ipilimumab is a type of immunotherapy drug known as a checkpoint inhibitor, which helps your own immune system attack cancer cells.
15727902|NCT05041049|Device|Comparing Visual Reality to High-fidelity mannequin Stimulation|"This is a prospective, randomized, non-inferiority study. VR will be compared to HFS, which will be considered the a priori gold standard for residents simulation training.
~The study will be divided into two phases. In the pre-test phase, participants will be randomly allocated to receive either a VR or HFS scenario (scenario 1, see below). In the post-test phase, all participants (regardless the initial grouping) will undergo a HFS scenario (scenario 2, see below).
~All scenarios have been chosen from critical events published by the Society of Pediatric Anesthesia48 and adult sources49.
~The study will be conducted at the McGill University Health Center - Research Institute (MUHC-RI)."
15727903|NCT05041036|Drug|Nirogacestat (Gamma Secretase Inhibitor)|Patients will receive nirogacestat tablets to be taken orally.
15727904|NCT05041023|Other|Relative section|"Relatives are assessed by phone calling with an experienced psychologist at 3 and 6 months after patient's death. Relatives answer to self-questionnaire and 3 scales.
~Furthermore, 20 of them are offered to participate in a semi-structured interview with an experienced psychologist, within 6 months to 1 year following the patient's death."
15727905|NCT05041023|Other|Caregiver section|"Caregivers are self-evaluated within 72 hours after death by questionnaire survey, whose results will remain confidential to the center that included the situation.
~Furthermore, 20 of them (10 medical staff and 10 paramedical staff and / or until saturation) are offered to participate in a semi-structured interview with an experienced psychologist."
15727988|NCT05040295|Drug|ritlecitinib|10 mg pediatric capsule
15727907|NCT05041010|Drug|Placebo group|1st infusion of the same volume of saline in patients receiving endovascular therapy within 12 hours following ischemic stroke onset followed by 9 consecutive infusions of same volume of saline at intervals of 12 ± 1 hours, twice a day
15727908|NCT05040997|Diagnostic Test|Small airways assessment|Small airways assessment
15727909|NCT05040984|Drug|Solifenacin Oral Tablet|Solifenacin 1 tablet per day
15727910|NCT05040984|Drug|Mirabegron 25mg|Mirabegron 1 tablet per day
15727913|NCT05040945|Procedure|Traditional corticotomy|Adult patients will be treated by extraction of maxillary first premolars with applying mini-screws between maxillary second premolar and first molar as temporary skeletal anchorage devices (TSADs). Then en-masse retraction associated with traditional corticotomy will be applied.
15727914|NCT05040945|Procedure|Flapless corticotomy|Adult patients will be treated by extraction of maxillary first premolars with applying mini-screws between maxillary second premolar and first molar as temporary skeletal anchorage devices (TSADs). Then en-masse retraction associated with flapless corticotomy will be applied.
15727915|NCT05040932|Drug|YH004|IV infusion once every 3 weeks (Q3W).
15727916|NCT05040919|Other|collection of medical and socio-demographic data|collection of medical and socio-demographic data
15727917|NCT05040906|Drug|H02+CHOP|"Drug:H02 375 mg/m2,administered intravenously(IV) on Day1 of each 21-day cycle for 6 cycles.
~Drug : Cyclophosphamide 750 mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle.
~Drug:Doxorubicin 50 mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle.
~Drug :Vincristine 1.4mg mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle.
~Drug: Prednisone 100 mg administered orally on Days 2-6 of each 21-day cycle."
15727918|NCT05040906|Drug|Rituxan +CHOP|"Drug: Rituxan 375 mg/m2,administered intravenously(IV) on Day1 of each 21-day cycle for 6 cycles.
~Drug : Cyclophosphamide 750 mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle.
~Drug: Doxorubicin 50 mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle.
~Drug : Vincristine 1.4mg mg/m2,administered intravenously(IV) on Day 2 of each 21-day cycle.
~Drug: Prednisone 100 mg administered orally on Days 2-6 of each 21-day cycle."
15727919|NCT05040893|Behavioral|Physiotherapy|"Interventions will include:
~Education and self-management strategies, including the use of wearable activity and real-time heart rate monitors, to safely guide pacing and activity.
~Breathing pattern education and retraining (including diaphragmatic, relaxed, and paced breathing exercises).
~Return-to-activity exercise programming (e.g., postural, aerobic, and whole-body strengthening exercises)."
15727920|NCT05040880|Drug|Telmione plus 80/12.5mg|Test drug (Fixed-dose combination drug of telmisartan 80mg and hydrochlorothiazide 12.5mg)
15727921|NCT05040880|Drug|Micardis plus 80/12.5mg|Reference drug (Fixed-dose combination drug of telmisartan 80mg and hydrochlorothiazide 12.5mg)
15727922|NCT05040867|Other|Physical exercise program|"The physical exercise programme will last 16 weeks where participants will do three weekly sessions of 60 minutes, approximately. In these training sessions, cardiovascular and strength components will be worked out, planned from moderate to high intensity in the TEG and unique high intensity in the HRVG. The training programme will be divided into three mesocycles from neuromuscular adaptation to reach, in last period, the highest loads and cardiovascular levels. Each session will include a warm-up, a main part and a cool-down with stretching and mobility exercises.
~The difference between the interventions of the HRVG and TEG will be in the planning of the intensity of the cardiovascular exercises and the weight to be lifted in the strength exercises. The first session of both programmes will have the same intensity but depending on how the heart rate variability of the HRVG patients reacts to, the weight and the intensity will be individualised each day."
15727923|NCT05040854|Genetic|HLA-DQA1*05 and DRB1|All patients will be asked to give blood samples to search for HLA-DQA1*05 and DRB1
15727924|NCT05040841|Behavioral|M1/OTR: Immediate outreach to subject due to unsuppressed viral load test result|"Standard of care viral loads are drawn at month 4, month 12 and annually thereafter. Those with a raised viral load are often not immediately recalled, but identified at their next visit (1-2 months later) and asked to attend the Risk of Treatment Failure (ROTF) clinic for adherence support when they next attend. For subjects assigned to M1 we will add a call or other outreach (e.g., text, Whatsapp, in accordance with the outreach methods subjects indicate are appropriate for them at the Enrollment visit); to the subject as soon as a raised viral load result is received (±3-5 days), thus expediting entry to existing adherence support. There are two chances to be identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M1."
15727925|NCT05040841|Behavioral|M2/PRM: Immediate outreach to subject after a missed pharmacy refill|The subject will be contacted if he/she fails to collect medication from the pharmacy. A subject who is ≥7 days late for a monthly medication pick-up or 14 days late for a 2-monthly pick-up will be notified, again expediting entry to existing adherence support. There are 8-10 chances of being identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M2.
15727926|NCT05040841|Behavioral|M3/EAM: Immediate outreach to subject after EAM-identified missed doses|The subject will be contacted if he/she misses ≥4 doses or any three consecutive doses in a 14-day period, reviewed weekly, as identified by the EAM (electronic adherence monitor). There are 52 chances of being identified as nonadherent and linked immediately to existing adherence support in the first 12 months of care with M2.
15727927|NCT05040841|Behavioral|S1/Text: Weekly check-in texts|"Subject will receive weekly check-in texts in addition to the core adherence support component in the event they are identified as nonadherent and are linked with the Risk of Treatment Failure clinics. Subjects will be sent weekly simple but supportive text messages e.g. how are you? with the offer of a follow-up voice call for 16 consecutive weeks after being identified as nonadherent."
15727928|NCT05040841|Behavioral|S2/Peer: Enhanced peer group support|"Subject will receive an enhanced form of peer group support. Standard of care Basic peer groups are led by lay counsellors and provide social support and education; this will continue to be provided to all patients who are not assigned to the enhanced version. Enhanced peer group support will replace the Basic standard of care 4 x 60 minute peer groups; and aim to improve long-term maintenance of adherence through motivational interviewing over 4-8 weeks."
15727929|NCT05040828|Behavioral|Start taking Montelukast Sodium Tablets 10mg quaque die orally two weeks before peak pollen count.|Start taking Montelukast Sodium Tablets 10mg quaque die orally two weeks before peak pollen count.Intranasal corticosteroids (mometasone furoate) 100μg was used in the group after peak pollen count.
15727930|NCT05040828|Behavioral|Montelukast Sodium Tablets 10mg quaque die orally was administered after peak pollen count.|10mg quaque die orally was administered after peak pollen count.Intranasal corticosteroids (mometasone furoate) 100μg was used in the group after peak pollen count.
15727931|NCT05040828|Drug|No oral drug therapy throughout the pollen period|Intranasal corticosteroids (mometasone furoate) 100μg was used in the group after peak pollen count.
15727932|NCT05040815|Radiation|chemo-radiation treatment|Radiotherapy (RT) with concurrent 5-fluorouracil and mitomycin-C (5FU/MMC) combination is the treatment of choice for non-metastatic locally advanced anal squam
15727933|NCT05040802|Other|Not applicable / dataset analysis|Not applicable / dataset analysis
15727934|NCT05040789|Biological|CoVLP formulation|"The Coronavirus-Like Particle (CoVLP) COVID-19 Vaccine is composed of recombinant spike (S) glycoprotein expressed as virus-like particles (VLPs).
~The 3.75 µg dose of CoVLP will be administered with the adjuvant AS03 (manufactured by GlaxoSmithKline)."
15727935|NCT05040776|Drug|EP-7041 Injection|EP-7041 infusion
15727936|NCT05040763|Diagnostic Test|Buccal Swab- Copan flocked swab|All participants will have a buccal swab sampled collected from the inside of the mouth either by themselves or by their caregiver
15727937|NCT05040763|Diagnostic Test|Standard of Care COVID-19 swab|All participants will receive a standard of care COVID-19 swab collected by a qualified healthcare professional
15727938|NCT05040750|Other|laboratory investigation|observe the relation between cardiac markers and mortality rate in critically ill COVID 19 patients
15727939|NCT05040737|Device|PS membrane versus PMMA membrane,|Patients will be dialysed according to the usual dialysis schedule of three weekly sessions. The study has a duration of 8 days in order to include 4 haemodialysis sessions. The first and third haemodialysis sessions will be dialysed with PS membrane and the second and fourth sessions with PMMA membrane, both dialysers with a surface area of 1.8 m2.
15727940|NCT05040724|Drug|Ivermectin|ivermectin placebo
15727941|NCT05040711|Behavioral|Mindfulness Coach|"This study will use Mindfulness Coach, an iOS- and Android-based app designed to deliver a mindfulness training course centered on Veteran's Affairs (VA) protocols. Developed by the VA's National Center for PTSD, the app provides an engaging introduction to MT, regardless of specific psychiatric illness or patient population. The app provides a training plan with 14 sequential levels, a practice now area with evidence-based mindfulness audio exercises, assessments using the Five-Factor Mindfulness Questionnaire Short Form (FFMQ-SF)90, and education about mindfulness. To progress to the next level, the user must interact with every element. The training plan levels include psychoeducation and exercises (guided meditations and seated practices), which increase in duration as users progress. Levels 1,7 and 14 also include an assessment with the FFMQ-SF. The practice now area has guided meditations to practice new skills."
15727942|NCT05040711|Behavioral|Active Comparator|A a widely available health and wellness app that provides users with daily content on general health, WebMD, will serve as the attention control. Similar health-based apps have been used as controls in other mHealth psychotherapy intervention trials.100,101 The control group will be instructed to access the app 4x/week (same as intervention group) and will receive an orientation and 2 booster sessions as well. I considered other control group options including treatment as usual, but attention control was selected due to the variability of treatment as usual.
15727943|NCT05040698|Drug|Fostamatinib|Open label Fostamatinib
15727944|NCT05040685|Procedure|Axillary mapping reverse|At the time of performing the ALND associate the ARM, injecting between 2-5mL of indocyanine green subcutaneously in the ipsilateral upper extremity at the medial inter-muscular and massaged for 5 min. First, identify the ARM nodes by indocyanine green, then perform conventional axillary lymphadenectomy trying to preserve the ARM nodes. And, in a second time, extract ARM nodes for their individualized anatomopathological study.
15727945|NCT05040672|Behavioral|questionare online application|questionare online application
15727946|NCT05040659|Device|AROMHA Longitudinal Smell Test|The AROMHA Longitudinal Smell Test is a self-administered, at-home smell test intended for use as a screening test by asymptomatic individuals to help prevent exposure to and spread of SARS-CoV-2, the virus that causes COVID-19, through a serial testing approach. The device consists of six versions of a smell card, each containing three unique odors.
15727947|NCT05040646|Other|Delphi exercise|"During the Delphi exercise both patients and experts will participate in two anonymous online survey rounds where different items/outcomes will be presented that are possibly related to rectal cancer and the W&W program. Both groups are asked to rate each item on a 9 point likert scale with respect to the importancy of the item.
~After the two subsequent rounds, participants will be invited to attend a consensus meeting, where final consensus about the most important outcomes will be reached."
15727948|NCT05040633|Device|BTL 4110 Smart Laser Therapy Equipment (BTL Industries Ltd, United Kingdom (UK))|Participants will receive 12 LLLT sessions during the course of the trial, thrice weekly for 4 consecutive weeks. Doses will be as per the recommendations of the Wold Association of Laser Therapy.
15727949|NCT05040633|Other|Standard Exercise Therapy|Exercise therapy will consist of strengthening and stretching exercises. At each visit, participants will perform each of the exercises under the supervision of a licensed physiotherapist.
15727950|NCT05040620|Drug|Olive Oil Topical Oil|the effect of olive oil local application in decreasing orthodontic alighment phase
15727951|NCT05040607|Other|Data Collection|"The first stage of the study:
~Retrospective data collection of pulmonary function, respiratory muscle strength, exercise capacity, physical fitness, and activities of daily living (ADL).
~The second stage of the study
~Retrospective data of pulmonary function, respiratory muscle strength, functional capacity before and after supervised inspiratory muscle training with POWERbreathe K5 device and airway clearance techniques performed for 6 weeks in PCD with decreased respiratory muscle strength (Intervention Group).
~Retrospective data of pulmonary function, respiratory muscle strength, and functional capacity before and after airway clearance techniques performed for 6 weeks as home-based therapy in PCD with decreased respiratory muscle strength (Control group)."
15727952|NCT05040607|Other|Data Collection|-Retrospective data collection of pulmonary function, respiratory muscle strength, exercise capacity, physical fitness, and activities of daily living (ADL)
15727953|NCT05040594|Device|PavéDerm J-Fill Soft Dermal Filler|Sodium Hyaluronate 20 mg with Lidocaine hydrochloride 3 mg/mL
15727954|NCT05040594|Device|Restylane® Lyft Lidocaine|Sodium Hyaluronate 20 mg with Lidocaine hydrochloride 3 mg/mL
15727955|NCT05040581|Behavioral|1-Day CBT-Based Workshop for Preventing PPD|The intervention is a 6-hour long CBT-based workshop. The intervention will be delivered in in modules and contain content on PPD etiology (with a focus on modifiable risk factors), the development of cognitive skills including cognitive restructuring, behavioural skills such as problem solving, sleep strategies, behavioural activation, assertiveness, and self-care, and the final module will involve goal setting and action planning.
15727956|NCT05040581|Other|90-Minute Information Session|Control group participants will be invited to attend a 90-minute information session about PPD.
15727957|NCT05040568|Drug|Cetuximab|Given IV
15727958|NCT05040568|Drug|CB-NK-TGF-Î²R2-/NR3C1|Given IV
15727959|NCT05040568|Drug|Fludarabine phosphate|Given IV
15727960|NCT05040568|Drug|Cyclophosphamide|Given IV
15727961|NCT05040555|Combination Product|R-CDOP|Rituximab 375mg/m2, D0; Cyclophosphamide 750mg/ m2, D1; Doxorubicin hydrochloride liposome 30-35mg/ m2, D1; Vindesine 3mg/ m2, D1; Prednisone 60mg/ m2, D1~5.
15727962|NCT05040529|Procedure|pure laparoscopic donor hepatectomy|pure laparoscopic donor hepatectomy: patients who underwent pure laparoscopic right or right extended hepatectomy for liver donation at gangnam severance hospital
15727963|NCT05040529|Procedure|conventional open donor hepatectomy|conventional open donor hepatectomy: patients who underwent conventional right or right extended hepatectomy for liver donation at gangnam severance hospital
15727964|NCT05040503|Biological|Blood sampling at inclusion|"Sampling of 2 tubes of 3 ml:
~patient: H0: 0-6h post-admission
~healthy volunteer: at inclusion"
15727965|NCT05040503|Biological|Blood sampling at 24 hours|Collection of 2 tubes of 3 ml (H24: 24-30h post-admission)
15727966|NCT05040503|Other|Data collection|clinical and biological medical data for patients and general health data for healthy volunteers
15727967|NCT05040490|Drug|sugammadex as reversal drugs|use sugammadex to reverse neuromuscular blockade
15727968|NCT05040477|Other|Muscle energy Technique|"Muscle Energy technique was used to increase the strength of weak muscles,relaxation of tightened muscles in result mobilizes the restricted joint segments.MET's group received 3-5 repetition of post isometric relaxation (PIR).
~Treatment through Facet Joint Mobilization based on 3 sets of 15 repetitions of unilateral poster-anterior glide (UPA) using initially grade I & II mobilizations followed by grade III of mitland glides on selected tender segments and 5 repetitions of extension sustained natural apophyseal glides (SNAGs) on hypo mobile segments.
~Conventional therapy comprising of stretching and isometric strengthening exercises in combination with TENS and heat therapy."
15727969|NCT05040464|Drug|AZA capsules|oral AZA capsules at a daily dose of 2.5 mg per kilogram,
15727970|NCT05040464|Drug|MTX|MTX 25 mg SC once a week
15727971|NCT05040464|Biological|blood sample|The lab tests are: serum albumin, C-reactive protein, thrombocytosis and haemoglobin.
15727972|NCT05040451|Device|Carillon Mitral Contour System|"The Carillon Mitral Contour System (XE2) consists of the following components:
~An implant intended for permanent placement in the coronary sinus (CS)/great cardiac vein (GCV)
~A delivery system which consists of a custom 9F delivery catheter and a handle assembly."
15727973|NCT05040438|Biological|Vax-NK/HCC|autologous NK cells expanded ex vivo.
15727974|NCT05040425|Drug|Zi-Yin-Liang-Ge-San|Zi-Yin-Liang-Ge-San is composed of five herb ingredients, namely Rx. Scutellariae (Huang Qin), Rx. Glycyrrhizae (Gan Cao), Hb. Dendrobii (Shi Hu), Rx. Ophiopogonis (Mai Men Dong), and Hb. Menthae Haplocalycis (Bo He). It is orally administrated trice daily from the first day to the end of RT in the treatment group, aiming to prevent and manage the OM. ZYLGS is manufactured as a concentrated herbal extract, constituted 4 g per packet, and origin from pharmaceutical companies in Taiwan with good manufacturing practice (GMP).
15727975|NCT05040412|Device|difficult laryngoscopy|Patients will be intubated with the direct laryngoscope.
15727976|NCT05040399|Other|Locking Compression Plates|Plates and screws for sternal fixation
15727977|NCT05040399|Other|Sternal Wires|sternal wires used for fixation of sternum
15727978|NCT05040386|Behavioral|ENABLE-COPD|Participants randomized to the intervention arm receive usual COPD care + ENABLE-COPD. ENABLE (Educate, Nurture, Advise, Before Life Ends) is a theory-based, rigorously tested, and multicomponent early palliative care model that improved quality of life and emotional symptoms in patients with advanced cancer. The PI adapted ENABLE to meet the specific needs of patients with COPD and their care partners. ENABLE-COPD includes a series of weekly telephone-based, nurse coach-led sessions for patients (six) and their care partners (four) aided by a manualized curriculum. Participants also complete activities geared to solving problems and making difficult decisions, attend a Supportive Care clinic visit, and complete advance directives.
15727979|NCT05040386|Other|Usual COPD Care|Participants randomized to this arm receive standard of care for COPD. This includes routine clinic visits with their clinician, medications, inhalers, vaccinations, tobacco cessation counseling, illness education, cardiopulmonary rehabilitation, specialist referrals, and other COPD therapies deemed appropriate by their clinician.
15727980|NCT05040360|Drug|Capecitabine|Given PO
15727981|NCT05040360|Drug|Temozolomide|Given PO
15727982|NCT05040347|Other|test NETs markers|NETs markers (Myeloperoxidase, Neutrophil elastase, Citrate histone H3) and anti-β2 glycoprotein I were detected in plasma using capture ELISA and specific ELISA kits.
15727983|NCT05040334|Drug|Group 1: Antibiotic receiving group|Group 1; receiving antibiotic prophylaxis; single dose of oral doxycycline (200 mg) tablet and metronidazole (500 mg) tablet 2 hours before the surgical evacuation Group B ;receiving placebo 2 hours before the surgical evacuation
15727984|NCT05040321|Drug|MIB-626|Participants will be randomized to either receive MIB-626 or matching placebo. The proposed intervention - targets multiple contributors to the pathology of AD; MIB-626 improves mitochondrial function, bioenergetics, and insulin sensitivity, inhibits A beta accumulation by reducing its synthesis and increasing its clearance, reduces neuroinflammation, exerts neuronal protective effects, and promotes neuronal regeneration and connectivity in preclinical models.
15727985|NCT05040321|Drug|Placebo|Subjects will be randomized to receive either the placebo or 500mg MIB-626 twice daily orally.
15727987|NCT05040295|Drug|ritlecitinib|30 mg intact adult capsule
15727990|NCT05040282|Device|Implanon NXT|women will be subjected to etonogestrel 68 mg implant insertion. Participants will be trained on how to fill the menstrual diary. The menstrual diary includes information about days of bleeding and spotting days.
15727991|NCT05040243|Other|Yanqing Zhitong Ointment Acupoint application|Yanqing Zhitong Ointment is a traditional external preparation of experiential prescription, which is an extract made by water extraction and concentration of Qingfengteng, Corydalis yanhusuo, Interleukin, Kansui, Asarum, etc. Clinical studies in the past ten years have preliminarily shown that it has the effects of warming meridians, promoting blood circulation, dredging collaterals and relieving pain, and has a definite effect.
15727992|NCT05040243|Other|placebo acupoint application|"The control group was combined with placebo acupoint application on the basis of conventional acupuncture treatment.
~Placebo patch: colored and drug-free patch (composition: petrolatum, food coloring) Acupuncture, application of acupuncture points and treatment course were the same as those in the treatment group."
15727993|NCT05040217|Genetic|AAV2-BDNF Gene Therapy|AAV2-BDNF is a genetically engineered adeno-associated virus serotype 2 (AAV-2) that expresses the human BDNF cDNA.
15727994|NCT05040217|Biological|AAV2-BDNF Gene Therapy|Gene therapy is a biological therapy delivering the BDNF gene to the brain
15727995|NCT05040204|Dietary Supplement|Monosaccharide Powder|Monosaccharide powder dissolved in water.
15727996|NCT05040204|Dietary Supplement|Placebo Comparator|Placebo (glucose powder)
15727997|NCT05040191|Other|Traditional Education(control)|The application was made on the model that allows nasogastric tube application and the anatomical structure in the nasogastric region is seen. The student can experience the skill of applying a nasogastric tube to the nasogastric or orgastric region on this model. In the nursing skills laboratory, students were given a demonstration of nasogastric tube application on a model.
15727998|NCT05040191|Other|Haptic interactive virtual reality simulation training|Haptic interactive virtual reality simulation technology; It functions by using haptic gloves that are interactive, visually enhanced, containing three-dimensional video and animation, wearable by students. This program has been developed by a software developer who is an expert in the field of information technologies, using the unreal program with a nine-generation computer with a game engine. All the necessary steps in the NGT application have been in simulation.
15727999|NCT05040191|Other|Haptic interactive computer-based simulation training|"Clinical tvr (tactile simulator) produced by a foreign commercial company used in nursing education was used. Clinical tvr simulation applications can be accessed online or downloaded to a computer. This simulator; It functions by using an interactive, visually enhanced 2D, animated, haptic arm that can be held by students like a pen. It includes applications such as nasogastric tube placement, urinary bladder catheter placement, heart massage. These applications can be realized through both mouse and haptic arm computer input devices. clinical tvr; It is a simulator that incorporates the enhanced benefits of haptic feedback through the use of haptic technology. This simulator provides a near-realistic sensory experience where the learner can practice a skill as it actually is. Computer-based simulation with haptic interaction was used in this study with the haptic arm in NGT application skill."
15728000|NCT05040178|Drug|Carglumic Acid|The dose of Carbaglu® prescribed will be determined by the investigator for each individual patient.
15728001|NCT05040165|Device|Iceform liner and sleeve|Subjects will be asked to use the investigational device as their primary prosthesis for up to 6 months. TPE material durability evaluated through monthly online questionnaires.
15728002|NCT05040152|Behavioral|Dietary Counseling and Surveillance|Receive dietary recommendations
15728003|NCT05040152|Other|Exercise Intervention|Complete home exercises
15728004|NCT05040152|Other|Informational Intervention|Receive education brochures
15728005|NCT05040152|Other|Questionnaire Administration|Ancillary studies
15728006|NCT05040152|Behavioral|Telephone-Based Intervention|Receive telephone-based weight loss intervention
15728007|NCT05040139|Procedure|Malone Procedure|Surgical procedure performed to obtain a percutaneous caecal access for the administration of antegrade colonic enemas. Briefly, the procedure is performed under general anesthesia. The surgeon bring the end of the appendix (or a tubulized segment of the ileum) out through the abdominal wall. The appendix is opened and sutured to the abdominal skin.
15728008|NCT05040139|Procedure|Percutaneous endoscopic caecostomy|Endoscopic procedure performed to obtain a percutaneous caecal access for the administration of antegrade colonic enemas. Briefly, a coloscopy is performed to reach the caecum. The cutaneous location of the caecostomy is determined by transillumination of the caecum. A caecopexy is performed with 3 anchors at the chosen location. A specific pig-tail catheter (Chait catheter) is placed percutaneously into the caecum in the center of the 3 anchors.
15728009|NCT05040126|Drug|Linezolid|"Participants will have a screening period of up to 14 days and will be randomized to one of the study arms in the ratio of 1:1:1, using an interactive web response system.
~Each participant will receive 26 weeks of treatment. If the participant's 16th-week sample remains culture positive, treatment will be extended up to 39 weeks.
~Participants will be followed for 48 weeks after the end of treatment"
15728010|NCT05040126|Drug|Bedaquiline|Bedaquiline will be administered as four 100 mg tablets (400 mg) by mouth once a day for 2 weeks, followed by two 100 mg tablets (200 mg) by mouth three times a week for 24 weeks in all three arms
15728011|NCT05040126|Drug|Pretomanid|Pretomanid is administered as one tablet once a day for 26 weeks in all three arms
15728012|NCT05040113|Drug|CBP-307|CBP-307 capsules oral administration
15728013|NCT05040100|Other|3D Mediastinum Model|The 3D model cohort was provided with an additional 10-minute interactive lecture reviewing the same focused mediastinal anatomical structures using the 3D model.
15728014|NCT05040087|Other|Intensification of diabetes medication based largely on HbA1c levels|Use of diabetes Rx in controls will be guided largely by HbA1c levels.
15728015|NCT05040087|Other|Intensification of diabetes medication based on glucose levels|Use of diabetes Rx in the intensive Rx groups will be guided by participants' self-monitored blood glucose levels (SMBG), with management aimed to keep glucose levels within the normal range.
15728016|NCT05040074|Device|SQ-Kyrin Transcatheter Edge-to-Edge Valve Repair System|Transesophageal echocardiography-guided, implantable mitral valve clip repair system
15728170|NCT05038852|Device|smartphone applications|app is designed to help you increase your positive feelings, behaviors, and thoughts.
15728171|NCT05038839|Drug|Cabozantinib|Given PO
15728172|NCT05038839|Drug|Pamiparib|Given PO
15728017|NCT05040061|Behavioral|SkillJoy Intervention|The savoring treatment consisted of an ecological momentary intervention (EMI) for learning and practicing savoring skills-SkillJoy. SkillJoy prompted participants to attend to positive aspects of the present moment, plan and engage in enjoyable activities, record and reflect on positive experiences, note events that turned out well, and look forward to positive events.
15728018|NCT05040061|Behavioral|Active Self-Monitoring Control Intervention|The active self-monitoring control EMI prompted participants to notice and write current thoughts and feelings, plan the day's major activities, remember and write about their daily events, and anticipate upcoming important events.
15728019|NCT05040048|Other|Clinical, biological and imaging assessment|
15728020|NCT05040035|Diagnostic Test|ACT measurement|Measurement of active clotting time (ACT)
15728021|NCT05040022|Drug|Pneumoperitoneum pressure 10 mmHg|The abdomen will be inflated with carbon dioxide to maintain the intra-abdominal pressure at 10 mmHg (group 10)
15728022|NCT05040022|Drug|Pneumoperitoneum pressure 14 mmHg|The abdomen will be inflated with carbon dioxide to maintain the intra-abdominal pressure at 14 mmHg (group 14).
15728023|NCT05040009|Behavioral|integrated foot care program|"Regular foot care and examination by an adequately trained professional: -
~Structured education:
~Educational modality will be provided to patients in a structured way. This will take many forms: one-to-one verbal education session last around 30 min motivational interviewing, video education, booklets, pictorial education via animated drawing or descriptive images structured foot care education consists of information on:
~Foot ulcers and their consequences
~Preventative foot self-care behaviors
~Wearing adequately protective footwear
~Undergoing regular foot checks
~Practicing proper foot hygiene
~Seeking professional help in a timely manner after identifying a foot problem
~3-Adequate footwear 4-Foot-related exercises and weight-bearing activity 5-Foot examination and screening 6- Instructions about foot self-management"
15728024|NCT05039996|Behavioral|education and relaxation program|randomized controlled trial
15728025|NCT05039983|Other|EGCG|EGCG use various concentrations dissolved in 0.9% saline solution three times a day. A new batch is made up each time. For esophageal application, repeated swallowing of 10 ml of the EGCG solution is indispensable to assure the prolonged presence of drug the esophageal walls.
15728026|NCT05039970|Other|WellQuest™|WellQuest™ is a mobile device-based serious health game.
15728027|NCT05039957|Other|joint preparation|fixation of fracture with joint preparation
15728028|NCT05039957|Other|without joint preparation|fixation of fracture without joint preparation
15728029|NCT05039944|Drug|SI-B001|Administration by intravenous infusion
15728030|NCT05039944|Drug|Irinotecan|Administration by intravenous infusion
15728031|NCT05039944|Drug|FOLFIRI Protocol|Administration by intravenous infusion
15728032|NCT05039944|Drug|Folfox Protocol|Administration by intravenous infusion
15728033|NCT05039931|Drug|GNC-035|Administration by intravenous infusion.
15728034|NCT05039918|Behavioral|Affective touch|Gentle stroking at CT-optimal speed
15728035|NCT05039905|Drug|99mTc-MSA-ICG|Intratumoral injection of 99mTechnetium-manosylated albumin-indocyanine green to lung cancer patients
15728036|NCT05039892|Drug|3D185|All eligible subjects will receive the RP2D regimen to be established based on the results of the ongoing phase I study from Cycle 1 Day 1 (C1D1) until disease progression, intolerable toxicity, withdrawal of consent, whichever occurs first.
15728037|NCT05039866|Biological|ST-920|No study drug is administered in this study. Subject who received ST-920 in a previous trial (ST-920-201) will be evaluated in this trial for long-term safety.
15728038|NCT05039853|Behavioral|Brief cognitive task-based intervention|Memory reminder procedure, playing the computer game, Tetris , on a smart-device using mental rotation.
15728039|NCT05039853|Behavioral|Placebo activity|Listening to a pod-cast on a smart-device for approximately 15 minutes.
15728044|NCT05039827|Other|Mobilization with movement|Heating fermentation was done for 10 minutes as baseline treatment. MWM with wrist extension was given for alternative days in a week as per 3 sessions per week for 4 weeks.
15728045|NCT05039827|Other|Soft Tissue Mobilization|Heating fermentation was done for 10 minutes as baseline treatment. Parallel and longitudinal massage was given for alternative days in a week as per 3 sessions per week for 4 weeks
15728046|NCT05039814|Other|postoperative acute kidney injury|patients suffered postoperative acute kidney injury
15728047|NCT05039814|Other|none postoperative acute kidney injury|patients did not suffered postoperative acute kidney injury
15728048|NCT05039801|Drug|Glutaminase Inhibitor IPN60090|Given PO
15728049|NCT05039801|Biological|Pembrolizumab|Given IV
15728050|NCT05039788|Other|Measurement of systolic and diastolic blood pressure, impedancemetry, weight, creatinemia and Pro-BNP measurements|"Measurement of systolic and diastolic blood pressure, impedancemetry, weight, creatinemia and Pro-BNP measurements At D30 and D90
~Measurement of systolic and diastolic blood pressure, impedancemetry, weight, 3 times a week between D30 and D90 post-transplant,"
15728052|NCT05039762|Procedure|Extracorporeal anastomosis|Laparoscopic right hemicolectomy will be carried out. The dissection is performed laparoscopically. When the right hemicolon is sufficiently mobilized and the vessels (ileocolic pedicle, right colic pedicle and the right branch of the middle colic pedicle) are ligated, a horizontal incision in the upper right quadrant is made. Through this incision the right hemicolon is extracted, the small bowel and the transverse colon are divided using staplers. The side-to-side ileocolic anastomosis is then handsewn.
15728205|NCT05038553|Other|No intervention|No intervention
15728206|NCT05038540|Procedure|Scaling and root planing|Phase 1 periodontal therapy
15728575|NCT05035654|Drug|LYR-220 Design 1|LYR-220 drug matrix (mometasone furoate 7500 µg) Design 1
15728053|NCT05039762|Procedure|Intracorporeal anastomosis|Laparoscopic right hemicolectomy will be carried out. The dissection is performed laparoscopically. The right hemicolon is mobilized and the vessels (ileocolic pedicle, right colic pedicle and the right branch of the middle colic pedicle) are ligated. The small bowel and the transverse colon are then divided using laparoscopic staplers. The side-to-side ileocolic anastomosis is formed by creating a small opening in the small bowel and the transverse colon, through which the laparoscopic stapler is used to join the bowel ends. The remaining opening is sutured laparoscopically. The specimen is retrieved through a Pfannenstiel incision.
15728054|NCT05039749|Device|Human Centric Lights|Bright light is emitted during the day from 06:00, then auto-dimmed light is used at night, beginning 19:00.
15728055|NCT05039736|Drug|Cabozantinib|Given by PO
15728056|NCT05039736|Drug|Nivolumab|Given by IV
15728057|NCT05039723|Drug|Radiesse, Xeomin, Belotero|Rejuvenation with Radiesse, Xeomin, Belotero
15728060|NCT05039697|Other|oxygen|deliver high flow oxygen (10L/min)
15728061|NCT05039671|Behavioral|Measurement-based care (MBC)|Clinicians will receive a 3-hour interactive MBC training followed by six months of post-training consultation. Training and consultation will include how to collect, score, and use student- and parent-reported progress measures with students and families to inform collaborative progress monitoring and treatment decisions.
15728062|NCT05039658|Drug|IBI110 plus sintilimab|Sintilimab is a NMPA approved high-affinity, ligand-blocking, humanized anti-programmed death-1 (PD-1) IgG4 antibody that blocks the binding of Programmed death-ligand 1 (PD-L1) and programmed death-ligand 2 (PD-L2) to PD-1.
15728063|NCT05039658|Drug|IBI110|BI110 is a high-affinity, ligand-blocking, humanized anti- Lymphocyte Activation Gene-3 (LAG-3) IgG4 antibody that blocks the binding of LAG-3 to MHCII.
15728064|NCT05039645|Behavioral|Patient specific, clinician determined Intervention|Data collected from the DFS device will be transmitted to a remote, cloud-based server for daily review using the SRI software. If a temperature difference of >2.2°C between similar points on the left and right feet is identified for 2 consecutive scans, or visible signs of skin damage are observed, the site will be notified and sent a report containing the findings. Once notified the site will contact the patient by telephone and determine the best course of action based on standard practices (e.g. offloading, attending an appointment).
15728065|NCT05039632|Other|Hafnium Oxide-containing Nanoparticles NBTXR3|Given intratumorally
15728066|NCT05039632|Biological|Ipilimumab|Given IV
15728067|NCT05039632|Biological|Nivolumab|Given IV
15728068|NCT05039632|Radiation|Radiation Therapy|Undergo Abscopal radiation therapy
15728069|NCT05039632|Radiation|Radiation Therapy|Undergo RadScopal radiation therapy
15728077|NCT05039606|Drug|Nedaplatin|Nedaplatin is a second-generation platinum-like derivative, which is a cell cycle non-specific drug, with a mechanism of action and efficacy similar to cisplatin, and a wide anti-cancer spectrum
15728078|NCT05039606|Drug|Cisplatin|Cisplatin, aka cis-dichlorodiamineplatin, is a platinum-containing anticancer drug
15728079|NCT05039593|Other|chlorhexidine|The population of the research is the patients hospitalized in the Internal Medicine intensive care unit of Aydın Adnan Menderes University Practice and Research Hospital between 01.06.2021 and 01.06.2022, and the sample is; Patients who are older than 18 years of age, who are in the first 24 hours of mechanical ventilation, who are 18 years of age and older, and whose relatives have consented.Oral care of the patients will be done with 0.12% chlorhexidine solution, and the frequency of oral care will be in three groups. Oral care will be done twice a day for the patients in the first group, 3 times a day for the patients in the second group, and 4 times a day for the patients in the third group. Oral care of the patients will be applied according to the guide used in the training given to the nurses.
15728080|NCT05039580|Drug|PD-1 monoclonal antibody|PD-1 monoclonal antibody is a new attempt treatment, and ruxolitinib and/or low-dose dexamethasone can reduce the inflammation that occur in EBV-HLH or CAEBV.
15728081|NCT05039567|Behavioral|optimal heart team protocol|Heart teams in the experimental group will be established and trained based on the optimal heart team implementation protocol. The protocol included instructions on specialist selection, specialist training, team composition, team training and formal implementation precess.
15728237|NCT05038228|Drug|Rivaroxaban|Anticoagulant
15728238|NCT05038228|Drug|Dabigatran|Anticoagulant
15728239|NCT05038228|Drug|Vitamin K antagonist (VKA)|Anticoagulant
15728086|NCT05039528|Behavioral|Personalized OSA messages|Participants will receive personalized OSA messages designed to nudge and navigate them toward evaluation and treatment for OSA. Participants will complete questionnaires at baseline and at study follow-up.
15728087|NCT05039528|Other|Control|Participants will complete questionnaires at baseline and at study follow-up. At the end of the study period, participants will receive the OSA message intervention.
15728088|NCT05039515|Drug|IPN60130|Immediate-release capsule containing high dose of the drug substance.
15728089|NCT05039515|Drug|IPN60130|Immediate-release capsule containing low dose of the drug substance.
15728090|NCT05039515|Drug|Placebo|Placebo will be supplied as powder filled hard capsules
15728091|NCT05039502|Other|Protaper Universal Retreatment|D1-D2-D3 Retreatment files were used in 500 rpm and 3 Ncm with X-Smart endomotor
15728092|NCT05039502|Other|Reciproc|R25 retratment files were used with X-Smart endomotor in reciprocal motion
15728093|NCT05039502|Other|XP-Endo finisher R|XP-Endo finisher r file were used in 1000 rpm 1 Ncm with X-Smart endomotor
15728094|NCT05039489|Drug|Antipsychotic drugs|Stable antipsychotic medication 4 weeks before and during the treatment. Chlorpromazine (CPZ) equivalent dosages were calculated for second- and first-generation antipsychotic drugs
15728095|NCT05039489|Device|cTBS（the left temporoparietal cortex as the stimulation target）|Participants received 3 daily sessions of cTBS treatment. One session of cTBS was 40 seconds in duration and consisted of 3-pulse bursts at 50 Hz repeated every 200 milliseconds (5 Hz) until a total of 600 pulses was reached. To achieve cumulative aftereffects, this protocol was repeated 3 times and (1800 pulses in total) separated by two 15 minute breaks
15728096|NCT05039489|Device|cTBS （the left cerebellum Crus II as the stimulation target）|Participants received 3 daily sessions of cTBS treatment. One session of cTBS was 40 seconds in duration and consisted of 3-pulse bursts at 50 Hz repeated every 200 milliseconds (5 Hz) until a total of 600 pulses was reached. To achieve cumulative aftereffects, this protocol was repeated 3 times and (1800 pulses in total) separated by two 15 minute breaks
15728097|NCT05039476|Dietary Supplement|Retinol face cream|Retinol face cream
15728098|NCT05039476|Dietary Supplement|Placebo face cream|Placebo face cream
15728099|NCT05039450|Drug|EFX|Investigational drug, Efruxifermin
15728100|NCT05039450|Drug|Placebo|Placebo
15728101|NCT05039437|Dietary Supplement|MGF-4|Participants were instructed to take 2 capsules of MGF-4 twice a day, and measure own blood pressure at morning everyday throughout the duration of the study.
15728102|NCT05039437|Dietary Supplement|MGF-7|Participants were instructed to take 2 capsules of MGF-7 twice a day, and measure own blood pressure at morning everyday throughout the duration of the study.
15728105|NCT05039411|Biological|Human umbilical cord mesenchymal stem cells (UC-MSCs)|All patients to receive 1st dose of 125 million UC-MSCs and the 2nd dose of 150 million UC-MSCs only if patients have no clinical improvement post 24 weeks after 1st dose
15728106|NCT05039398|Behavioral|Treatment as usual|The workplace receives dialogue and guidance during the WEA workplace inspection as per WEA standard practice.
15728107|NCT05039398|Behavioral|Dialogue and guidance over telephone|"In addition to receiving dialogue and guidance during WEA workplace inspection as standard practice by the WEA, the Dialogue and guidance over telephone receives up to 2 hours of supplemental dialogue and guidance after WEA inspection with the WEA inspector. This is conducted over the telephone."
15728108|NCT05039398|Behavioral|Dialogue and guidance at physical meeting|"In addition to receiving dialogue and guidance during WEA workplace inspection as standard practice by the WEA, the Dialogue and guidance at physical meeting receives up to 2 hours of supplemental dialogue and guidance after WEA inspection with the WEA inspector. This is conducted as a physical meeting."
15728134|NCT05039164|Behavioral|Coping Power Program (CPP)|CPP is an evidence-based intervention designed for students with externalizing behavior disorder. CPP consists of twelve 45-minute sessions. This EBP has been found to be effective at reducing aggressive behavior, covert delinquent behavior and substance abuse among aggressive boys, with gains maintained at one-year follow-up. Growth curve analyses showed that CPP had linear effects for three years after intervention on reductions in aggressive behavior and academic behavior problems.
15728316|NCT05037539|Drug|Morphine|Oral Morphine Syrup 2.5 ml ( 5 mg)
15728317|NCT05037526|Device|Dexcom G System|Continuous glucose monitoring system
15728109|NCT05039385|Other|Exercise Program focused on resistance training|"The program will be carried out by a personal trainer. To ensure correct execution, given that the groups will be of a maximum of 5 people. Each session will include:
~A) Warm up: movility exercises and coordination games B) Main part: 3 exercises will be included to strengthen different muscle groups (pull , bench press and back squat). Velocity based training (VBT) will be used to control load. 3 sets of 16-30 repetitions mantaining the speed between Light (estimated loss of speed of the series 5-10%).
~C) Cool down: feedback with patients based on the work of Stiles-Shields (2015).
~Specific training content will focus on safety, while re-educating patients on proper exercise methods, motivation-related attitudes, and transparency on health benefits and potential harms as a result of increased exercise."
15728110|NCT05039372|Behavioral|TRAINING AND CONSULTANCY|TRAINING AND CONSULTANCY
15728111|NCT05039359|Drug|Placebo|Vehicle-matched inhalation solution
15728112|NCT05039346|Other|Phone interviews|Phone interviews will be used to determine the patient's quality of life, symptoms and performance status
15728113|NCT05039333|Device|RUS(TM) software : surgical navigation|This clinical trial is a sponsor-led clinical trial, and it is intended to confirm that RUS™, a surgical navigation system certified for level 2 endoscopic imaging treatment planning software, can be applied to real people as a clinical study by using preoperative CT and to confirm the safety of surgery. In addition, the secondary research objective was to examine the accuracy of the intra-abdominal surgical navigation system provided by RUS™ including: 1) the accuracy of the undulation prediction model, 2) the accuracy of the trocar insertion position, 3) the adequacy of 3D reconstruction of the main vessels, 4) the accuracy of the major vessel branching distances, 5) the intraoperative bleeding volume and operating time, and 6) the postoperative hospitalization period and complication rate were compared with the past control group.
15728114|NCT05039320|Dietary Supplement|Bactoblis|dissolve the tablets in the mouth once a day for 4 weeks
15728115|NCT05039320|Dietary Supplement|Placebo|dissolve the tablets in the mouth once a day for 4 weeks
15728116|NCT05039307|Behavioral|Educational and motivational strategy|The intervention will focus on the following topics A) Healthy diet: food pyramid, a healthy plate distribution, type of carbohydrates and fats, healthy cooking techniques and healthy oils. B) Physical activity: definition, types of physical activity, advantages and benefits, examples, active physical activity sessions. C) Weight control: strategies, benefits and healthy weight gain during pregnancy. D) Knowledge and awareness of T2DM and GDM: definition, prevention, management and complications. These topics will be delivered through individualized education, group sessions and focus groups. Participants will be provided with printed material at baseline and also during the individual education sessions at the household containing a brief summary of the topics covered. The motivational components of goal setting and the use of a pedometer will be incorporated explained during the individual education sessions. The intervention will be primarily delivered by trained peer educators.
15728117|NCT05039294|Behavioral|School-Based Physical Activity Educational Program|The structure of the educational sessions includes physical education lectures, group discussions, videos, training sessions, physical activities diaries, short quizzes, and feedback after each session. The educational programs were conducted among students with intervention groups at two-level individually and in school. The individual-level includes classroom lectures that mainly emphasized the health benefits of physical activity and provided necessary information about physical activity fitness for 60 minutes and were given weekly for four weeks. In coordination with the school sports teacher, training sessions included moderate to vigorous physical activities for 45 minutes twice weekly for four weeks
15728118|NCT05039281|Biological|Atezolizumab|Given IV
15728119|NCT05039281|Drug|Cabozantinib|Given PO
15728120|NCT05039268|Drug|3K3A-APC Protein|3K3A-APC with intravenous dosing of five doses of either 15mg or 30mg at 12 hourly interval. The first 8 patients will receive 15mg dose, and the next 8 patients will receive 30mg dose.
15728121|NCT05039242|Other|Conventional Physical Therapy)|"Participants will receive a Hand exercise program including 8 different movements according to Flat 20 (flexion, extension, radial deviation of the fingers, dorsal flexion, palmar flexion, ulnar deviation of the fingers, and opposition and abduction of thumbs.
~Repetitions include 5 times during each session, as given in the study. Balanced resistive hand exercise with use of physio hand ball squeezes including finger abduction and adduction exercises with MCP extended and gross grip.
~Each contraction to be held for 3-5 seconds with a 20-second rest between contractions. Five repetitions of each resistive exercise will be done."
15728122|NCT05039242|Other|Kinesiotaping with I shaped application|Participants will receive Kinesiotape, by using I application technique from proximal to distal on dorsum of hand and forearm with less than 50% stretch of the subjects on both hands, once a week for a total time period of 4 weeks with 4 KT applications in total (19). Kinesiotape will be worn by the subjects for 3 days. basic hand exercises will accompny it. Weekly assessments will be completed for pain, ROM, joint stiffness, grip strength and ADLs.
15728123|NCT05039242|Other|Kinesiotaping with Fan-shaped Application|"Participants will receive exercise interventions as group A along with that the Kinesiotape will be applied, by using fan cut application technique on MCP joints involving extensor tendons of fingers on dorsal surface of both hands of subjects, once a week for a total time period of 4 weeks with 4 KT applications in total.
~Kinesiotape will be worn by the subjects for 3 days. Less than 50% stretch with space correction technique. basic hand exercises will accompny it. Weekly assessments will be completed for pain, ROM, joint stiffness, grip strength and ADLs."
15728124|NCT05039229|Other|Nozzles (NZ)|Technical intervention targeting alteration of nozzles or nozzle function along the production line, e.g. by manipulation of nozzle dimensions, alteration of operating pressure or shielding of the nozzle's output stream. How the intervention is to be carried out in detail in the respective factory is to be developed in collaboration with the factory staff. This can include local specific characteristics, specific location of intervention or others.
15728125|NCT05039229|Other|Cleaning of surfaces (CS)|Behavioural or technical intervention. This can include increased use of swabbing instead of flushing with water hoses or alterations in use of water hoses for cleaning. Examples for the latter are a reduced flushing frequency, reduction of number of employees executing the work, alterations of hose dimension or nozzles on hoses. How the intervention is to be carried out in detail in the respective factory is to be developed in collaboration with the factory staff. This can include local specific characteristics, specific location of intervention or others.
15728126|NCT05039216|Biological|Blood sampling|4 tubes of 7 mL will be sampled
15728135|NCT05039164|Behavioral|CBT for Anxiety Treatment in Schools (CATS)|CATS is an adaptation of Friends for Life (FRIENDS). The adapted protocol retains the core elements of evidence-based CBT for anxiety and the FRIENDS group format. Investigators implemented planned adaptations to the protocol based on collective experience. Changes were made to the language, cultural methods, number of sessions, and activities while maintaining the 5 essential components of the treatment. This resulted in a briefer (8-session) and more feasible, engaging and culturally appropriate protocol for urban under-resourced schools than the original FRIENDS.
15728136|NCT05039164|Behavioral|Check-in/Check-out (CI/CO)|CI/CO is a targeted, Tier 2 intervention for students at risk of developing externalizing and internalizing mental health disorders. CI/CO is designed to provide immediate feedback (i.e., at the end of each class period) to students, based on the use of a daily report card. This feedback is developmentally sensitive. CI/CO implementers meet individually with students for a brief 'check-in' in the morning and a brief 'check-out' in the afternoon. Research on the use of CI/CO has shown it to be effective in reducing externalizing and internalizing problems with elementary school students. CI/CO will be offered to individual students for a three-month period of time, which is the same time-frame needed for the implementation of CPP.
15728137|NCT05039151|Biological|interstitial fluid sampling|The sample will be taken from the patient's thigh, external third, with a subcutaneous sample using a green catheter (18G short), connected to a collection device (DrainaS). 1 to 10 ml of interstitial liquid will be collected. Any sampling will be preceded by the application of an EMLA patch at least 30 min before the procedure. A sample will be taken on D1 and D3.
15728138|NCT05039151|Biological|blood sampling|A blood sample (3 x 5 ml EDTA tubes) will be taken simultaneously. A sample will be taken on D1 and D3
15728139|NCT05039138|Other|NEUROMUSCULAR TRAINING EXERCISE|patients will receive neuromuscular training exercises in group II
15728140|NCT05039138|Other|traditional training exerises|traditional strength training exercises in group I
15728141|NCT05039125|Radiation|ultrasonic cavitation|"From a standing position, each participant's abdomen was divided transversally into three sections; resulting in a total of 6 abdominal segments.
~Part III: 3cm above the umbilicus to 2cm below the umbilicus
~After washing the skin on the anterior abdominal wall with alcohol, a conducting medium (gel) was placed to the ultrasonic instrument's cavitational head.
~The gadget was turned on, a 30-minute timer was set, and the intensity was gradually increased.
~The cavitation head then moved extremely gently in a small circular motion on each abdomen section for 5 minutes.
~After completing the ultrasonic application to the six regions of the abdomen, the skin was cleansed with a piece of cotton.
~For group (A): 40000 HZ ultrasound was delivered for 30 minutes, 3 times/week for 2 months.
~For group (B):26000 HZ ultrasound was delivered for 30 minutes, 3 times/week for 2 months"
15728142|NCT05039112|Device|Verofilcon A toric contact lenses|Soft contact lenses for optical correction of astigmatism, used as indicated
15728143|NCT05039112|Device|Stenfilcon A toric contact lenses|Soft contact lenses for optical correction of astigmatism, used as indicated
15728144|NCT05039099|Drug|AP-101|Participants receive multiple ascending doses of AP-101 by intravenous infusion (IV).
15728145|NCT05039099|Drug|Placebo|Participants receive multiple ascending doses of placebo by IV.
15728146|NCT05039086|Drug|PDE5 inhibitor|PDE5 inhibitors (sildenafil, tadalafil) claim is used as the exposure group.
15728147|NCT05039086|Drug|Endothelin Receptor Antagonists|Endothelin receptor antagonists (bosentan, ambrisentan, macitentan) claim is used as the reference group.
15728153|NCT05039060|Dietary Supplement|Modified MAC diet (3-weeks)|"Modified MAC diet to adapt reduced energy intake and increased dietary fiber consumption with appropriate nutrients component
~Dr.Kitchen Inc. directly provide home delivery service for the modified MAC diet including multigrain rice, meal kit, and snacks per day in a regular basis"
15728155|NCT05039034|Other|Advice according to primary prevention guidelines on stroke of China|
15728158|NCT05038982|Drug|Abrocitinib|During the study period, subjects will take one Abrocitinib 200 mg tablet once daily orally. Subjects will be directed to take doses of Abrocitinib at approximately the same time of day.
15728159|NCT05038969|Drug|Stomopral|1 capsule contains 40 mg Esomeprazole
15728160|NCT05038969|Drug|Nexium|1 capsule contains 40 mg Esomeprazole
15728161|NCT05038943|Device|Paragonix SherpaPak Cardiac Transport System|Transportation of cardiac allografts in a device maintaining constant optimal temperature to minimize freezing tissue injury
15728162|NCT05038930|Device|Mobilisation using the Sara Combilizer|The mobilisation with the Sara Combilizer, will be done one time either 24 or 48 hours after stable intracranial pressure
15728163|NCT05038904|Drug|Acalabrutinib|100 mg oral capsule
15728164|NCT05038891|Diagnostic Test|Digital Cervical Exam|Standard Digital Cervical Exam by an experienced OB provider
15728165|NCT05038891|Diagnostic Test|Transperineal Ultrasound|Self-administered transperineal ultrasound after instruction by a health care professional
15728166|NCT05038891|Diagnostic Test|Transvaginal Ultrasound|Self-administered transvaginal ultrasound after instruction by a health care professional
15728167|NCT05038878|Drug|Elagolix|Patients will be given Elagolix 200 mg orally twice daily for a total of 6 months
15728168|NCT05038865|Other|Malocclusion and Orthodontic Treatment|"Group 1 is exposed to malocclusion and orthodontic treatment. However, the inclusion in the study does not affect the treatment since it is an observational study.
~The exposure of group 2 is no malocclusion, no orthodontic treatment."
15728169|NCT05038852|Device|smartphone applications|app is designed to help you learn relaxation skills.
15728173|NCT05038813|Drug|Anlotinib+TQB2450|"Anlotinib: 12mg, orally once a day (orally before breakfast, the daily medication time should be as the same as possible), continuous taking for 2 weeks, stopping for 1 week, 3 weeks (21 days) as a treatment cycle, until the disease progresses or Intolerable.
~TQB2450: 1200mg, diluted to 250mL with normal saline, infusion time 60±10mins. The medication is taken on the first day of each cycle, and 3 weeks (21 days) is a treatment cycle. Until the emergence of disease progression or intolerable toxicity, the longest use time does not exceed 24 months."
15728177|NCT05038774|Other|Face to face Educational Training|"Key points of current hypertension guidelines.
~10-step checklist how to obtain standardized upper arm blood pressure readings according to guidelines.
~template of a blood pressure documentation sheet for serial documentation of blood pressure values by patients.
~checklists to assist in the diagnosis of secondary hypertension.
~Patient information leaflet about hypertension."
15728178|NCT05038774|Other|Printed Education Material|"Key points of current hypertension guidelines.
~10-step checklist how to obtain standardized upper arm blood pressure readings according to guidelines.
~template of a blood pressure documentation sheet for serial documentation of blood pressure values by patients.
~checklists to assist in the diagnosis of secondary hypertension.
~Patient information leaflet about hypertension."
15728179|NCT05038761|Device|Cascade CGM System|"Following the manner of observational study, no intervention will be used for the study.
~Participants will wear one Cascade CGM on abdomen or lower area for no longer than 14 days."
15728180|NCT05038761|Device|Blood Glucose Meter (BGM)|Calibration device
15728181|NCT05038748|Other|Psychiatric diagnosis|Kiddie Schedule for Affective Disorders & Schizophrenia (K-SADS) for DSM-5
15728182|NCT05038748|Other|ASD diagnosis|Autism Diagnostic Interview-revised (ADI-R) and Autism Diagnostic Observation Scale (ADOS)
15728183|NCT05038735|Drug|Alpelisib|Alpelisib (tablets) administered at 300mg orally once daily on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28 day cycle.
15728184|NCT05038735|Drug|Fulvestrant|Fulvestrant (prefilled syringe) 500mg administered intramuscularly at Cycle 1 Day 1 and 15 and then at Day 1 of each subsequent cycle (each cycle is 28 days).
15728185|NCT05038722|Other|Platelet transfusion|Transfusion of platelet concentrates according to routine practice.
15728186|NCT05038709|Device|The Pink Pad Hip Kit|The pad is placed between the patient and the traction table to reduce pressure to the pudendal nerve exerted by the perineal post.
15728187|NCT05038696|Biological|CAR T-cell therapy|This is a single-centre, phase I study to determine the efficacy and safety of CAR T-cell therapy in patients with high-risk B-ALL, refractory or relapsed B-ALL.
15728188|NCT05038683|Behavioral|Holbæk Obesity Treatment|"Obesity is a chronic, progressive, severe, recidivistic, and complex disease, which mandates that children and adolescents with overweight or obesity have access to a professional medical healthcare service as other pediatric chronic diseases, implying a lifelong course of treatment. The HOT method is further based on the physiological insight into the endocrine regulation of fat mass; especially on how the body adapts when it is challenged by weight loss. These insights include an understanding where the body shifts into an energy-preserving mode when the individual is initiating weight-reducing actions, such as a reduced caloric intake or an increased level of physical activity, which has numerus impacts on communication and pedagogy.
~HOT is administered by healthcare nurses and dietitians at healthcare centers in Danish municipalities. Each treatment will be conducted as face-to-face sessions totalling a range of six to 12 hours for 12 months."
15728189|NCT05038683|Behavioral|Conventional Obesity Treatment|"Obesity is viewed as a chronic disease that is ultimately thought to result from an imbalance between energy intake and energy expenditure. However, multiple factors, both environmental and genetic, are thought to influence the disease as well. As obesity reflects energy imbalances, the treatment plan should be designed to induce a slightly negative energy balance by focusing on diet, physical activity, and inactivity through behavior change. Taking one step at a time, will in the end lead to the same energy balance result (i.e. weight loss) and will be more sustainable for the participant whose motivation is absolutely pivotal in this process.
~COT is administered by healthcare nurses and dietitians at healthcare centers in Danish municipalities. Each treatment will be conducted as face-to-face sessions totalling a range of six to 12 hours for 12 months."
15728190|NCT05038670|Device|Total Knee Replacement|Participant will undergo total knee replacement performed via anterior parapatellar approach with either PERSONA PS or JOURNEY II BCS
15728191|NCT05038657|Drug|Atezolizumab|Treatment will consist of atezolizumab, by IV infusion, at a fixed dose of 1680 mg, every 28 days (day 1 of each cycle, +/- 3 days), for up to one year. Each participant will receive up to 13 doses in total.
15728192|NCT05038644|Drug|XmAb18968 - Dose level -1|0.1 mg IV C1D1, 0.3 mg IV C1D2, then 0.4 mg IV on D8, D15, and D22 in a 28-day cycle.
15728193|NCT05038644|Drug|XmAb18968 - Dose level 0 (starting dose)|0.2 mg IV C1D1, 0.6 mg IV C1D2, then 0.8 mg IV on D8, D15, and D22 in a 28-day cycle.
15728194|NCT05038644|Drug|XmAb18968 - Dose level 1|0.25 mg IV C1D1, 0.75 mg IV C1D2, then 1.0 mg IV on D8, D15, and D22 in a 28-day cycle.
15728195|NCT05038644|Drug|XmAb18968 - Dose level 2|0.4 mg IV C1D1, 0.9 mg IV C1D2, then 1.3 mg IV on D8, D15, and D22 in a 28-day cycle.
15728196|NCT05038644|Drug|XmAb18968 - Dose level 3|0.5 mg IV C1D1, 1.0 mg IV C1D2, then 1.5 mg IV on D8, D15, and D22 in a 28-day cycle.
15728197|NCT05038631|Drug|Ribociclib|50 mg and 200 mg hard gelatin capsules o tablets as individual patient supply packaged in bottles
15728198|NCT05038618|Biological|MVC-COV1901(S protein with adjuvant)|Approximately 400 participants will receive 2 doses of MVC-COV1901(S-2P protein with adjuvant) at Day 1 and Day 29 via intramuscular (IM) injection in the deltoid region
15728199|NCT05038605|Drug|Topical metronidazole|Topical application of metronidazole cream on the anal verge every 8 hours after surgery
15728200|NCT05038605|Drug|oral metronidazole|Patients received oral metronidazole 500 mg tablets every 8 hours after surgery
15728201|NCT05038592|Drug|Decitabine|Given IV
15728202|NCT05038592|Biological|Tagraxofusp-erzs|Given IV
15728203|NCT05038579|Procedure|Musiquence|The participants performed a customized cognitive stimulation program, that was implemented in an augmented reality format, using Musiquence.
15728204|NCT05038566|Device|Pointdexter|i-Digits partial hand prosthesis modified with the investigational pointdexter finger in place of the usual index finger.
15728207|NCT05038527|Device|ABM/P-15 bone graft|RCT (single blinded) where the patients will be randomized into two groups. One group receiving the standard bone graft which is a mix of locally autologous harvested bone and a morselized femoral head (allogenic) and the other group will receive bone graft of anorganic bovine bone mineral coated with a bioactive peptide (ABM/P-15).
15728208|NCT05038514|Other|musıc therapy|After the prone position was given to the patients, according to the randomization table, the intervention group was given 30 minutes by the nurse. nature-based music therapy will be applied.
15728209|NCT05038501|Other|To study comorbidities in patients undergoing Oncosurgeries|In the Preoperative Anaesthesia checkup we will study prevalence of comorbidities as Coronary artery Disease, Hypertension, Diabetes Mellitus , Hypothyroidism and prior Corona Virus Infection in patients undergoing Oncosurgeries
15728210|NCT05038488|Drug|MIB-626|Fifty participants will be randomized, stratified by sex, remdesivir use, and trial site, in a 3:2 ratio to receive either MIB-626 1.0 g orally or matching placebo twice daily for 14 days.
15728211|NCT05038488|Drug|Placebo|Subjects will be randomized to receive either the placebo or 1000-mg MIB-626 twice daily orally.
15728212|NCT05038488|Other|Home Treatment|Participants, who are discharged from the hospital before the completion of the 14-day intervention period, will be provided sufficient study medication to take home with them so they can continue to take the medication twice daily for the remaining duration of the 14-day intervention period.
15728213|NCT05038475|Diagnostic Test|COVID-19 antibody test|FDA-approved Immunoassays were used in the study. At the beginning of the study, up to 3 months, ELISA and CLIA immunoassays were adopted to analyze the antibody titers. Thereafter, CLIA was used for longitudinal analysis of antibody titers for consecutive months. Anti
15728214|NCT05038462|Dietary Supplement|Lactoferrin and DHA|The intervention consists in the maternal oral administration of 1000mg of Lactoferrin and 1000mg of DHA daily
15728215|NCT05038462|Other|Placebo|Product with the same physical appearance and taste as the main intervention but without therapeutic effect
15728216|NCT05038449|Drug|Colchicine Tablets|Colchicine Tablets (Each tablet contains colchicine 0.5mg)
15728217|NCT05038449|Drug|Standard therapy|Standard therapy for COVID-19 according to the Novel Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial 8th Edition)
15728218|NCT05038436|Device|Polyglucosamine L112|Two tablets are taken unchewed with each of two fat-containing meals daily
15728219|NCT05038423|Behavioral|5R Shared Leadership Program|"The manualised 5RS program aims to develop the leadership qualities of peer leaders by teaching them how to create, embody, advance, and embed a collective sense of 'us' in their teams. More specifically, 5RS consists of two key components that involve (1) implementing a structure of shared leadership, and (2) strengthening the identity leadership skills of the appointed peer leaders (Fransen et al., 2020).
~Fransen, K., Haslam, S. A., Steffens, N. K., Mallett, C. J., Peters, K., Mertens, N., & Boen, F. (2020). All for us and us for all: Introducing the 5R Shared Leadership Program. Psychology of Sport and Exercise, 51, 101762. https://doi.org/10.1016/j.psychsport.2020.101762 Haslam, S. A., Steffens, N. K., Peters, K., Boyce, R. A., Mallett, C. J., & Fransen, K. (2017). A social identity approach to leadership development: The 5R program. Journal of Personnel Psychology, 16(3), 113-124. https://doi.org/10.1027/1866-5888/a000176"
15728220|NCT05038423|Behavioral|12-week structured walking program|Participants engaged in an evidence-based 12-week structured walking program, which aimed to enhance participants' physical activity and aerobic fitness levels based on personalised walking schedules and weekly group walks organised by the community-based meeting points.
15728221|NCT05038410|Drug|Wobenzym®|Wobenzym®
15728222|NCT05038410|Other|Placebo|Microcrystalline cellulose
15728223|NCT05038397|Device|Theraspere|Prior to the administration of TheraSphere, the patient should undergo hepatic arterial catheterization using balloon catheterization or other appropriate angiographic techniques to prevent extrahepatic shunting. Following the placement of the hepatic catheter, 75 MBq to 150 MBq (2 mCi to 4 mCi) of Tc-99m MAA is administered into the hepatic artery to determine the extent of A-V shunting to the lungs and to confirm the absence of gastric and duodenal flow. When the possibility of extrahepatic shunting has been evaluated and the patient deemed acceptable for treatment, TheraSphere may be administered.
15728224|NCT05038384|Other|Survey Administration|Complete survey
15728225|NCT05038345|Procedure|Pull through surgery|The principal purpose of pull through surgery for Hirschsprung disease is to remove aganglionic bowel and reconstruct the intestinal tract by connecting the normally innervated bowel just above the anus so that normal sphincter function is preserved.
15728226|NCT05038332|Radiation|Ultra-hypofractionated radiation therapy|34 Gy in 5 fractions to prostate bed, every other day, M-F, ~2 weeks (25 Gy in 5 fractions to pelvic lymph nodes if included)
15728227|NCT05038332|Radiation|Moderately Hypo-fractionated Radiation Therapy|55 Gy in 20 fractions to prostate bed, daily, M-F, 4 weeks (42 Gy in 20 fractions to pelvic lymph nodes if included)
15728228|NCT05038319|Procedure|EUS|The procedures would be performed by a therapeutic endoscope with the through the scope method. The endoscope would be used to reach the site of Varices.
15728230|NCT05038293|Device|Automated mouthpiece-based toothbrush|One-time use during study visit.
15728231|NCT05038293|Device|Manual toothbrush|One-time use during study visit.
15728232|NCT05038280|Behavioral|Let's Talk about Children intervention|The LTC -intervention includes two steps: Let´s Talk about Children discussion and Let´s Talk about Children network meeting. Students, students´ parents, and a teacher take part in the LTC -discussion. The LTC logbook is used as the framework for the discussions. The LTC discussion depicts the child's ordinary day in all developmental contexts and an action plan is made with parents to enhance the identified strengths and to give support in vulnerabilities. When the action plan is difficult to carry out without further participants, the LTC-Network meeting is planned with parents (and sometimes also the child). LTC-Network meeting provides a forum for case-based cross-sectoral collaboration, including also the families and their social network.
15728233|NCT05038254|Other|Best Practice|Receive standard of care telemedicine
15728234|NCT05038254|Procedure|Patient Monitoring|Undergo remote monitoring
15728235|NCT05038254|Other|Questionnaire Administration|Ancillary studies
15728236|NCT05038228|Drug|Apixaban|Anticoagulant
15728240|NCT05038215|Behavioral|adherence promotion techniques|The experimental group will receive adherence promotion techniques in addition to routine care, including 1-additional information tailored for the spouse/partner, persons living with the patient. 2- Educational material delivered at follow up appointments and by mail at intervals agreed upon by the patient and the clinician. 3- Electronic reminder/communication system established by patient and provider. 4-Follow up communication from the dental provider of the oral appliance to the primary care physician and with patient's approval, their general dentist. 5- After the 3 month follow up visits the patient will be provided with reports about their appliance wear per week. 6-Gift card delivery, $25, at 6 month follow up if a follow up with sleep physician is scheduled.
15728241|NCT05038215|Procedure|Routine Care|The control group will receive routine care
15728242|NCT05038202|Drug|Bencycloquidium Bromide Nasal Spray|"The content of this product is a colorless and clear liquid, press the sprayer, the liquid will be sprayed out in mist.
~This product is suitable for improving the symptoms of runny nose, nasal congestion, nasal itching and sneezing caused by allergic rhinitis."
15728243|NCT05038202|Drug|Mometasone Furoate Aqueous Nasal Spray|"Mometasone furoate nasal spray is a quantitative hand-press spray device, and the content is a white to off-white suspension.
~This product is suitable for the treatment of seasonal or perennial rhinitis in adults, adolescents and children from 3 to 11 years old. For patients who have had moderate to severe seasonal allergic rhinitis symptoms, it is recommended to use this product 2-4 weeks before the start of the pollen season Preventive treatment."
15728244|NCT05038189|Diagnostic Test|Gait parameters|Trunk position sense as indicated by trunk reposition errors (TRE) and spine posture (thoracic and lumbar curvature) will be measured with a digital inclinometer. Gait analyses (cadence, stride length, swing phase duration, step duration and double stand duration) will be evaluated.
15728245|NCT05038189|Diagnostic Test|Spine posture|Trunk position sense as indicated by trunk reposition errors (TRE) and spine posture (thoracic and lumbar curvature) will be measured with a digital inclinometer. Gait analyses (cadence, stride length, swing phase duration, step duration and double stand duration) will be evaluated.
15728246|NCT05038189|Diagnostic Test|Trunk position sense|Trunk position sense as indicated by trunk reposition errors (TRE) and spine posture (thoracic and lumbar curvature) will be measured with a digital inclinometer. Gait analyses (cadence, stride length, swing phase duration, step duration and double stand duration) will be evaluated.
15728247|NCT05038176|Behavioral|MANUP|Intervention will include diabetes education, diabetes support with a focus on coping techniques (based on John Henryism concepts), physical activity engagement and motivational text messages.
15728248|NCT05038163|Other|Nutrition Facts|The nutritional information label for each beverage is enlarged.
15728249|NCT05038163|Other|Text Warning|The health risks of sugary beverages are communicated to subjects using words/text and simple images.
15728250|NCT05038163|Other|Graphic Warning|The health risks of sugary beverages are communicated to subjects using a combination of words/text and graphic images/photographs.
15728251|NCT05038150|Drug|SGN1|SGN1, will be administered as an IV infusion, via an IV catheter over 2 hours,which Unit Dose Strength is 0.9-2.0×109 cfu /vial.
15728252|NCT05038137|Behavioral|Time restricted feeding|Participants will eat all food during a self selected 8 hour eating window prior to 8:00 PM.
15728253|NCT05038137|Behavioral|Control|Participants will have a daily eating period equal to or greater than 12 hours.
15728254|NCT05038124|Radiation|Preoperative Stereotactic Body Radiotherapy (SBRT)|Target lesions will be treated with preoperative SBRT consisting of biologically effective dose (BED10) of 50.4 - 81.6 Gy delivered in either three fractions or a single fraction.
15728255|NCT05038111|Drug|Dexmedetomidine|perioperative dexmedetomidine infusion
15728256|NCT05038098|Procedure|Gastrectomy|Undergo surgery
15728257|NCT05038098|Drug|Indocyanine Green|Given peritumorally
15728258|NCT05038098|Other|Iron Conjugated Polymers in Saline Suspension|Given peritumorally
15728259|NCT05038085|Behavioral|progressive muscle relaxation exercise|"36-37 with pregnant women in the experimental group. There will be two online interviews starting from week one. Before the first interview, the PMRE video will be sent to the women, explained by the researcher. In the first meeting, basic information about postpartum depression and what to do to prevent postpartum depression and its treatment will be explained. The women will then be asked to describe the PKGE. Relaxation Exercises CD Audio Recordings belonging to the Turkish Psychological Association will be sent to women, and they will be asked to perform PMRE at least 3 days a week until delivery, accompanied by the instructions on the CD. In the second meeting; maternal attachment will be explained. In this interview, women will be asked to continue to do PMRE at least 3 days a week from the day they feel ready, starting at the latest 1 week after delivery."
15728260|NCT05038072|Drug|suprachoroidal injection of Triamcinolone Acetonide.|4 mg /0.1 ml TA was injected in the SCS using an individualized microinjector according to scleral thickness measured by anterior segment OCT (AS-OCT) at the injection point (4 mm from the limbus in the inferotemporal quadrant).
15728261|NCT05038059|Drug|ethanolic extract of sapindus mukorossi|ethanolic extract will be used as final endodontic irrigant during root canal procedures in extracted teeth.
15728262|NCT05038059|Drug|ethylene diamine tetra acetic acid|used as final endodontic irrigant in root canal therapy
15728263|NCT05038046|Other|Traditional Chinese Medicine (TCM) daycare model|Traditional Chinese Medical (TCM) daycare model provides multiple approaches of traditional Chinese medical treatment, including 5 tones of Chinese music, massage for meridians and collaterals, acupuncture, and patient education. The treatment course is one time a week, for 12 weeks (12 treatments in total).
15728264|NCT05038033|Behavioral|Interpersonal Psychotherapy (IPT)|The IPT group sessions follow three phases (initial, middle, and termination) and use the interpersonal inventory to identify interpersonal problems that might be contributing to or exacerbating disinhibited eating and anxiety symptoms. A framework of common problem areas is used to teach interpersonal problem-solving and communication skills and educate youth about risk factors and warning signs for excessive weight gain, such as eating in response to negative affect as opposed to hunger, or feeling a sense of loss-of-control while eating. IPT focuses on psychoeducation and general skill-building that can be applied to different relationships within the framework of four interpersonal problem areas: interpersonal role disputes, role transitions, interpersonal deficits, and grief.
15728318|NCT05037526|Device|Self monitoring blood glucose|Standard Care
15729678|NCT05027048|Drug|Saline placebo|see arm description above
15728265|NCT05038033|Behavioral|Cognitive Behavioral Theory (CBT)|The CBT program will be derived from Coping Cat, a manualized intervention for children and adolescents with elevated symptoms of anxiety. The group intervention builds skills for managing anxiety, in general, but with a focus on how anxiety prompts disinhibited eating, including attention to and restructuring of negative cognitions that perpetuate anxiety and behavioral exposure, rather than avoidance, of anxiety-provoking situations.
15728268|NCT05038007|Drug|Liposomal bupivacaine|As prior described
15728269|NCT05038007|Drug|Bupivacaine Hydrochloride|As prior described
15728270|NCT05037994|Procedure|Ultrasound Guided Continuous Suprascapular Nerve Block With methyl prednisolone and marcaine|"The high frequency linear ultrasound transducer (Sonosite 6-13 MHz) in a transverse orientation will be placed over the scapular Spine.
~Moving the transducer cephalad the suprascapular fossa will be identified. 18 gauge touhy needle will be inserted in plane after subcutaneous local anesthesia infiltration with 1 ml lidocaine 2% Real-time imaging will be used to direct injection of 2 ml lidocaine 2% to test perineural spread of injectate after confirmation of the position of tip of needle injection of 40mg methyl prednisolone diluted in 5 ml bupivacaine 0.5% will be done through the needle to anesthetize the nerve and create space for catheter insertion. After catheter insertion another 2 ml lidocaine 2% will be injected through the catheter to confirm position perineural in the scapular notch. Lastly Catheter will be fixed via skin tunnel and secured with skin sutures and adhesive tap."
15728271|NCT05037968|Device|MagnetOs Putty|Procedure: Instrumented Posterolateral Lumbar Fusion
15728272|NCT05037942|Other|Blood flow restriction at 40% limb occlusion pressure|A 13-cm-wide pneumatic cuff will be applied to the most proximal portion of the chosen thigh (as determined by randomisation), immediately distal to the inguinal fold, prior to a bout of lower-body resistance exercise. The cuff will be inflated to 40% of limb occlusion pressure pressure and will remain inflated throughout the exercise (total occlusion time: ~5 mins).
15728273|NCT05037942|Other|Blood flow restriction at 80% limb occlusion pressure|A 13-cm-wide pneumatic cuff will be applied to the most proximal portion of the chosen thigh (as determined by randomisation), immediately distal to the inguinal fold, prior to a bout of lower-body resistance exercise. The cuff will be inflated to 80% of limb occlusion pressure pressure and will remain inflated throughout the exercise (total occlusion time: ~5 mins).
15728274|NCT05037929|Drug|Astegolimab|Participants will receive SC astegolimab Q2W or Q4W.
15728275|NCT05037929|Drug|Placebo|Participants will receive SC placebo Q2W.
15728276|NCT05037916|Other|laser speckle contrast imaging device|laser speckle contrast imaging device will be used for measurement of burn wound depth en to be compared to the golden standard the laser doppler imaging device
15728277|NCT05037903|Behavioral|Cognitive-behavioral therapy|Cognitive and behavioral interventions aimed at increasing behavioral activation, and reducing procrastination and inattentive symptoms.
15728278|NCT05037890|Dietary Supplement|Margarine|Intake of margarine
15728279|NCT05037877|Dietary Supplement|HUM supplement|HUM supplement - 1 capsule per day
15728280|NCT05037877|Dietary Supplement|Placebo|Placebo supplement - 1 capsule per day
15728281|NCT05037851|Drug|PC945|Nebulizer suspension
15728282|NCT05037851|Drug|Standard of Care|Standard of Care
15728283|NCT05037838|Procedure|Longitudinal strain obtained thanks to transesophageal ultrasound data recorded during liver transplantation|Longitudinal strain of Left Ventricule and longitudinal strain of Right Ventricule free wall obtained thanks to TransEosophagal Ultrasound performed during the Liver Transplant
15728284|NCT05037825|Drug|Checkpoint Inhibitor, Immune|anti-PD-1, anti-PD-L1, or anti-CTLA-4 as a single agent or in combination with another checkpoint inhibitor or other treatment agent or modality (e.g., targeted therapy, chemotherapy, surgery, radiation, etc.) in accordance with FDA-labeled use of the agent
15728285|NCT05037812|Drug|Injection|Saline
15728286|NCT05037812|Drug|Injections|"5mg morphine, 500 micrograms epinephrine, and 4ml normal saline (superficial injection).
~2.5mg morphine, 40 micrograms clonidine, 15mg ketorolac, and 4ml normal saline (deep injection)."
15728287|NCT05037799|Drug|Rb-82 Radioisotope|Quadratic dosing: Rubidium-82 activity prescribed as a squared function of body-weight instead of linear function of body-weight or fixed activity independent of body-weight
15728288|NCT05037786|Behavioral|Infographic|Key themes related to pain and injury in elite players based on previous studies presented using an A3 infographic
15728289|NCT05037786|Behavioral|Powerpoint|Key themes related to pain and injury in elite players based on previous studies presented using a Powerpoint
15728290|NCT05037773|Behavioral|Intervention targeting parental reminiscing style|8-session intervention (i.e., 1 session/week) targeting 3 main aspects of parental reminiscing: the promotion of child participation, the structure of discussions about the past and the content addressed during these discussions. Different learning techniques are used: psychoeducation, modeling and supervised practice.
15728291|NCT05037760|Drug|KER-050 monotherapy|KER-050 administered (SC) for up to 13 cycles
15728292|NCT05037760|Drug|KER-050 in combination with ruxolitinib|KER-050 administered (SC) for up to 13 cycles in combination with standard of care ruxolitinib
15728293|NCT05037747|Behavioral|Time-restricted feeding(TRF)|The TRF group was asked to restrict the eating window to 8 hours a day, during waking hours and also continue a low-protein diet.
15728294|NCT05037734|Device|Persona Partial Knee System|Unicompartmental Knee Replacement
15728295|NCT05037721|Other|gargling with green tea|experimental group using 0.5% green tea gargle, control group use clear water gargle, secondary in daily use mouthwash after breakfast and lunch after 30 minutes, 15 ml each use gargle for 30 seconds, total 7 days
15728296|NCT05037721|Other|gargling with water|using water gargle, control group use clear water gargle, secondary in daily use mouthwash after breakfast and lunch after 30 minutes, 15 ml each use gargle for 30 seconds, total 7 days
15728319|NCT05037513|Behavioral|SBCM-PrEP|Multi-session SBCM intervention adapted for PrEP initiation focus
15728320|NCT05037513|Behavioral|CDC-PrEP|1 session PrEP education following CDC guidelines
15728323|NCT05037487|Drug|Placebo Cannabis|Smoked placebo cannabis
15728324|NCT05037487|Drug|20 mg CBD Cannabis|Smoked cannabis with CBD
15728297|NCT05037708|Procedure|Manual lymphatic drainage|"Subjects are randomly assigned to group 1. Group 1 receives treatment A* for 4 weeks.
~Afterwards, a period of washing or bleaching should be allowed in order to be sure that the effects of the intervention have disappeared. This period will last 2 months during which the usual treatment for LGA patients will be carried out, which consists of 2 monthly physiotherapy sessions, in this way it is intended that the subjects are in the initial state (as before the start of the first intervention). After this washout period, treatment B** was applied to group 1 for 4 weeks.
~*Treatment A consists of manual lymphatic drainage.
~**Treatment B consists of no treatment"
15728298|NCT05037708|Procedure|Manual lymphatic drainage|"Subjects are randomly assigned to group 2. Group 2 receives treatment B** for 4 weeks.
~Afterwards, a period of washing or bleaching should be allowed in order to be sure that the effects of the intervention have disappeared. This period will last 2 months during which the usual treatment for LGA patients will be carried out, which consists of 2 monthly physiotherapy sessions, in this way it is intended that the subjects are in the initial state (as before the start of the first intervention). After this washout period, treatment A* was applied to group 2 for 4 weeks.
~*Treatment A consists of manual lymphatic drainage.
~**Treatment B consists of no treatment"
15728299|NCT05037695|Drug|empagliflozin 25 MG|empagliflozin 25mg - daily
15728300|NCT05037682|Other|Dissemination and Implementation Research|The study will employ a research and implementation design that attempts to balance scientific rigor, research good practices, primary care implementation preferences and numerous limitations related to the study context. A waitlist-controlled, staggered implementation study will be conducted with three groups of 15 practices introduced to the intervention in 3-month intervals, each baseline overlapping with interim measurements of care quality and process outcomes in concurrent groups in every 3 months, followed by a final data collection at the end of the intervention in months 16 and 17, including baseline measures plus semi-structured interviews. The groups and their sequence will not be randomized, but practice characteristics will be used to distribute them among the three groups based on location, type, size and patient mix to maximize the balance of practices among the groups.
15728301|NCT05037669|Biological|PACE CART19|PACE CART19 cells are allogeneic T cells transduced with a lentiviral vector to express an anti-CD19 scFv TCRz:41BB and electroporated to temporarily express the CRISPR/Cas9 RNA system resulting in beta-2 microglobulin (B2M), Class II Major Histocompatibility Complex Transactivator (CIITA) and TCR-α chain (TRAC) targeted disruption. PACE CART19 cells will be administered by IV infusion.
15728302|NCT05037656|Behavioral|School-based curriculum|Participants will be randomized, at the school level, to receive either the e-cigarette/tobacco/areca nut use prevention curriculum or the standard of care (i.e., control). The curriculum will be implemented using 5 intensive in-class lessons over the span of 6 weeks. All sessions of the curriculum follow the same basic format: a) an introduction and/or review of the past lesson, b) a cultural wall activity, c) a video, d) 1-2 interactive activities, and e) a wrap-up activity. Lessons are designed such as to help improve knowledge about drugs and correct cognitive misperceptions and to train on skills to resist normative social influence. Participants will complete identical survey questionnaires for assessments at 3 time-points: pretest (baseline, before implementing the intervention), immediate posttest (following the end of the intervention), and six-month follow-up. The surveys will be administered in the classroom, during regular school hours.
15728303|NCT05037643|Procedure|TIPS|Transjugular Intrahepatic Portosystemic Shunt is performed to prevent / treat symptomatic portal hypertension
15728306|NCT05037604|Other|Questionnaire about associated factors|Questionnaire about age, prolonged sun exposure, intake of anticoagulants / antiplatelets, intake of oral steroids, chronic kidney disease. Maternal age> 40 years in their last child , time of lactation per pregnancy and cumulative time of lactation. Age of the first pregnancy and age of menopause onset.
15728307|NCT05037604|Diagnostic Test|Self questionnaire diagnostic tool|Self questionnaire of physical characteristics
15728308|NCT05037604|Other|Physical Examination|Physical Examination made by a dermatologist
15728309|NCT05037591|Drug|Sea grapes extract 1.68 g/70kg BW|Contains antioxidants 45.66 ± 0.55% and Caulerpin. Sea grapes are usually consumed raw without any indication of poisoning.
15728310|NCT05037591|Drug|Placebo|placebo lactose powder (1.68 g/70kg BW day-1).
15728311|NCT05037578|Behavioral|Project Grace|A multilevel church-based intervention to encourage cognitive screens and brain health.
15728312|NCT05037565|Dietary Supplement|Partially hydrolyzed guar gum|Partially hydrolyzed guar gum (PHGG) is a vegetal, water soluble, non-viscous, non-gelling dietary fiber that is derived from guar gum, a water-soluble, viscous, gelling polysaccharide found in the seeds of Cyamopsis tetragonolobus. PHGG is available over the counter as a dietary supplement as fiber.
15728313|NCT05037552|Procedure|Bipolar coagulation|"Cystectomy will be done via laparoendoscopic surgery After identifying the correct plane of cleavage, the stripping technique will be used. The cyst wall will be gently pulled down from the remaining ovary with two pairs of atraumatic forceps.
~Once the whole cyst wall will be separated from the ovary cortex, bleeding of the remaining ovarian stromal tissue will be controlled by bipolar coagulation. Then, the remnant tissue will be examined using irrigation and coagulated with minimal bipolar power (20-W current) on any sites that are bleeding."
15728314|NCT05037552|Procedure|Coagulation by FLOSEAL haemostatic agent|"Cystectomy will be done via laparoendoscopic surgery After identifying the correct plane of cleavage, the stripping technique will be used. The cyst wall will be gently pulled down from the remaining ovary with two pairs of atraumatic forceps.
~Once the whole cyst wall will be separated from the ovary cortex, bleeding of the remaining ovarian stromal tissue will be controlled by either hemostatic sealants (FloSeal). Using a laparoscopic applicator, FloSeal will be applied to the surface of bleeding sites under direct vision and the ovarian cortex was gently pressed for 2 min with small gauze."
15728315|NCT05037539|Drug|Fentanyl Citrate 50Mcg/Ml Inj_#1|Injectable Fentanyl in Sublingual Route 50 mcg
15728327|NCT05037474|Procedure|TLE group|all patients underwent a transvenous lead extraction/explantation (TLE) procedure
15728328|NCT05037461|Radiation|High-dose-high precision MR-guided radiotherapy|MR-guided radiotherapy as described in the group information
15728329|NCT05037448|Behavioral|Me & My Wishes|Me & My Wishes videos communicate residents' preferences via personalized video recorded conversations. Me & My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts.
15728330|NCT05037435|Biological|The pentavalent rotavirus vaccine (live attenuated oral, freeze-dried)|Group 1 (20 participants) - received the pentavalent live vaccine to prevent rotavirus infection Single-use orally 2.5 ml (1 dose).
15728331|NCT05037435|Other|Placebo|Group 2 (20 participants ) - received placebo orally once of 2.5 ml (1 dose).
15728332|NCT05037422|Procedure|STARR surgery|"This intervention is carried out under general anesthesia or spinal anesthesia. It consists of the circular resection of the surplus of rectal mucosa. Rectal resection and suturing is performed using automatic mechanical forceps introduced through the anus."
15728335|NCT05037396|Drug|Brolucizumab|Participants received brolucizumab injection during the index period
15728336|NCT05037383|Other|Video recordings|The surgery of the patient will be recorded by cameras placed on the top of the displays used by the operating staff. The recordings will be only carried out while the patient is draped for the surgery, thus completely covered.
15728337|NCT05037370|Device|Wave-Front Optimized (WFO) ablation vs Topography-guided (TG) ablation|Patient will undergo PRK or LASIK using WFO ablation in one eye and TG ablation on contralateral eye
15728338|NCT05037357|Diagnostic Test|Plasma EBV DNA qPCR test|Peripheral blood will be collected from each subject into an EDTA tube for the isolation of plasma.
15728339|NCT05037344|Behavioral|Cognitive-behavioral psychotherapy|The goal is to develop an internet and smart phone delivered CBT (iCBT) for the treatment of pediatric OCD on the bases of our feasibility study. This group will start directly with therapy of 16 weeks. The waiting group gets the same intervention after 16 weeks of waiting.
15728340|NCT05037318|Behavioral|Stress arousal reappraisal|Participants will read scripted instructions and summaries of scientific articles explaining that stress arousal is not harmful but rather functional and adaptive for performance in stressful situations.
15728341|NCT05037318|Behavioral|Worked examples|The worked example will be in form of brief video sequences showing a physician (played by an actor) delivering the bad diagnosis of lung cancer to an SP following the SPIKES protocol.
15728342|NCT05037305|Diagnostic Test|Pharmacogenomic Testing|"All individuals in the Arm One Pharmacogenetic Testing Cohort will be undergo pharmacogenomic testing, which will be performed in our CLIA-CAP certified clinical laboratory using the panel-based clinical pharmacogenomic assay used at Vanderbilt University Medical Center."
15728343|NCT05037292|Other|PAUSE Intervention|Standardized frailty screening and utilization of a frailty review board (PAUSE Board)
15728344|NCT05037279|Drug|Bacillus Calmette-Guerin: Strain Russian BCG-I|"Induction: 80 mg weekly for 6 weeks.
~Maintenance for intermediate AUA risk patients will be for 3 weeks at 3, 6, and 12 months.
~Maintenance for high AUA risk patients will be for 3 weeks at 3, 6, 12, 18, 24, 30 and 36 months."
15728345|NCT05037279|Drug|Bacillus Calmette-Guerin: Strain TICE|"Induction: 50 mg weekly for 6 weeks.
~Maintenance for intermediate AUA risk patients will be for 3 weeks at 3, 6, and 12 months.
~Maintenance for high AUA risk patients will be for 3 weeks at 3, 6, 12, 18, 24, 30 and 36 months."
15728346|NCT05037266|Biological|COVID-19 Vaccine Janssen (Ad26.COV2-S)|one dose (0.5mL) at D1
15728347|NCT05037253|Drug|Vitamin D|Patients will be randomised to receive either high dose vitamin D (50,000 IU weekly) on the first and second week, followed by a switch to a daily intake of 5,000 IU for 3 months or low dose vitamin D (2,000 IU weekly) for 3 months.
15728348|NCT05037240|Dietary Supplement|Quercetin|Quercetin (500 mg), 2 times a day for 3 months
15728349|NCT05037240|Combination Product|Placebo|500 mg, 2 times a day for 3 months
15728351|NCT05037188|Biological|Low dose BCD-250 injection|A recombinant viral vector AAV5-RBD-S vaccine
15728352|NCT05037188|Biological|High dose BCD-250 injection|A recombinant viral vector AAV5-RBD-S vaccine
15728353|NCT05037188|Biological|Low dose or high dose BCD-250 injection|A recombinant viral vector AAV5-RBD-S vaccine
15728354|NCT05037188|Other|Placebo injection|Placebo injection
15728355|NCT05037175|Behavioral|CPT-Text|CPT is a 12-session, trauma-focused, cognitive therapy that teaches clients to examine and change problematic beliefs about themselves and the world that were altered as a result of trauma. Each session includes psychoeducation and introduction of a new skill or module, which builds on the previous information and skills. Participants will receive psychoeducation video links via Talkspace and an electronic workbook with handouts, written explanations of the concepts and activities, and CPT worksheets, which will be embedded in the platform and sent by the therapist at the appropriate point in the protocol. Therapists encourage the client to complete each module using the provided materials and assist clients in reflecting on their beliefs through Socratic questions and feedback on their worksheets [5,6]. Clients work at their own pace, with therapists sending the skill or module after the client has practiced the previous one.
15728356|NCT05037175|Behavioral|Texting as Usual|TAU will be conducted by Talkspace therapists with a specialty in PTSD. Based on previous research and Talkspace's analysis of TAU, it is likely TAU will include supportive and client-centered interventions, problem solving, and elements from EBTs such as cognitive-behavioral therapy [5].
15728395|NCT05037006|Drug|Sevoflurane - Neostigmine 30|Neostigmine 30 mcg/kg and atropine 15 mcg/kg when TOFc 3
15728396|NCT05037006|Drug|Sevoflurane - Neostigmine 50|Neostigmine 50 mcg/kg and atropine 25 mcg/kg when TOFc 3
15728397|NCT05037006|Drug|Sevoflurane - Neostigmine 70|Neostigmine 70 mcg/kg and atropine 35 mcg/kg when TOFc 3
15728398|NCT05037006|Drug|TIVA - Neostigmine 30|Neostigmine 30 mcg/kg and atropine 15 mcg/kg when TOFc 3
15728357|NCT05037175|Behavioral|Retention Incentive|Participants will be told at baseline that they can retain their discount in subsequent months if they message with their therapist regularly. If client participants do not re-engage after 24 hours from the RAU (3 days without engagement), they will receive an automated text-message reminding them to message their therapist regularly (on average, every other business day) in order to get their 30% discount in the next month. They can choose to use the incentive themselves or donate it to Talkspace's assistance fund, which provides free therapy to individuals who demonstrate financial need.
15728358|NCT05037175|Behavioral|Reminder as Usual|As per Talkspace guidelines, therapists are available to client participants twice per day, five days per week. In the event a client participant has not engaged or messaged in 48 hours, therapists send a personalized message to the client participant to encourage them to re-engage.
15728359|NCT05037162|Diagnostic Test|Biochemistry blood test|preformed on days 1-14 and day 28. Sodium (Na), Potassium (K), Chloride (Cl), Creatinine, Glucose, Urea, Albumin, Calcium total, Alkaline Phosphatase (ALP), ALT, AST, Total Bilirubin, Direct Bilirubin, LDH, Total Protein, Uric Acid, CRP, and Lipid Profile (including Total Cholesterol, HDL,
15728360|NCT05037162|Diagnostic Test|Hematology blood test|preformed on days 1-14 and day 28. complete CBC.
15728361|NCT05037162|Diagnostic Test|D-Dimer test (coagulation)|performed on days 1,2,7,14 and 28.
15728362|NCT05037162|Diagnostic Test|Inflammatory markers|performed on days 1-7, 14 and 28. IL-6, IL-1β, IL-12, TNF α, IFN-γ
15728363|NCT05037162|Diagnostic Test|Vital signs|performed on days 1-14 and day 28. blood pressure, pulse, weight, weight, body temperature (PO), saturation, respiratory rate.
15728364|NCT05037162|Diagnostic Test|VAS scale|performed on all study visits. score: 0-10 ; a higher score indicates a higher pain level.
15728365|NCT05037162|Diagnostic Test|WHO Ordinal Score|performed on days 1,7,14 and 28. score: 0-3 ; a higher score indicates more symptoms.
15728366|NCT05037162|Diagnostic Test|COVID-19-Related Symptoms assessment|performed on days 1,7,14,21 and 28. score: 0-3 ; a higher score indicates more symptoms.
15728367|NCT05037162|Diagnostic Test|COVID-19-Impact on Quality-of-Life Questionnaire|performed on days 1,7,14,21 and 28. score: 1-5 ; a higher score indicates a lower quality of life.
15728368|NCT05037162|Diagnostic Test|POST- COVID-19 Functional Status Scale:|performed on day 28. score: 0-3 ; a higher score indicates better recovery.
15728369|NCT05037162|Diagnostic Test|Pregnancy test|performed on days 1 and 28. women of childbearing potential must undergo a urine pregnancy test.
15728370|NCT05037162|Diagnostic Test|Physical examination|performed on days 1-14 and day 28. a full examination by a doctor.
15728371|NCT05037162|Diagnostic Test|PK parameters|"performed on day 1. will be performed only on 14 patients that will agree to participate in the PK analysis (only for Brazil,Spain).
~The PK will be performed only for the first dose of drug, after patient received the first dose (5 puffs) the study staff need to follow the table below.
~For each test, approximately 5 ml of blood will be drawn (equivalent to one teaspoon)"
15728372|NCT05037162|Diagnostic Test|SARS-CoV-2 test (PCR)|performed on days 1,14 and 28.
15728373|NCT05037162|Diagnostic Test|ECG|performed on days 1 and 28.
15728374|NCT05037162|Drug|Treatment administration (twice a day)|performed on days 1 and 2. twice a day, morning, and evening 1:1:1 ratio to study drug (CimetrA-1) (Arm 1) or study drug (CimetrA-2) or to Placebo (Arm 3)
15728380|NCT05037123|Drug|Continuous ketamine infusion|Continuous ketamine infusion (0.35 mg/kg after induction, followed by 0.3 mg/kg/hr until 2 hours after surgery) plus saline IV dose in post-anesthesia care unit
15728381|NCT05037123|Drug|Ketamine + Saline|Saline dose and infusion intraoperatively, then single-dose IV ketamine (0.60 mg/kg) in post-anesthesia care unit plus 2 hours of saline administration after surgery
15728382|NCT05037123|Other|Placebo|Placebo, Saline dose and infusion intraoperatively, then saline IV dose in post-anesthesia care unit plus 2 hours of saline administration after surgery
15728383|NCT05037110|Behavioral|Physical activity|For 12 weeks, do 150 minutes of moderate-to-vigorous physical activity per week and wear a smart watch to monitor this physical activity goal. This is done remotely. Then, every two weeks, attend a remote individual meeting with a kinesiologist using a secured application (15 minutes each). Each online meeting will contain the following steps: 1) Review of health and activities recorded by the activity watch/app provided to the participant; 2) Discussion on how to reach/maintain the physical activity goal in the coming weeks according to individual health status, facilitators and barriers; 3) Elaboration of the next 2-week action plan.
15728384|NCT05037110|Other|Smell training|For 12 weeks, morning and evening, smell four odors namely eucalyptol, phenyl ethanol, citronellal, and eugenol, for a total of five minutes per session. For each smell training session, complete a short, online survey regarding the pleasantness and intensity of the smell. This is done remotely. Then, every two weeks, attend a remote individual meeting with a research professional using secured application (15 minutes each). Each online meeting will contain the following steps: 1) Review of smell training; 2) Discussion on how to reach/maintain the training protocol in the coming weeks according to individual health status, facilitators and barriers; 3) Elaboration of the next 2-week action plan.
15728385|NCT05037097|Biological|ARCT-165|Dose 3
15728386|NCT05037097|Biological|ARCT-154|Dose 2
15728387|NCT05037097|Biological|ARCT-021|Dose 1
15728388|NCT05037084|Other|no intervention|no intervention
15728389|NCT05037071|Device|Upper body graduated compression sleeve|An over the counter light compression sleeve will be worn during game training
15728390|NCT05037058|Other|Quality improvement activities|Quality improvement activities
15728391|NCT05037045|Drug|GLP-1 receptor agonist|GLP-1 RA was injected subcutaneously at standard dose and frequency for consecutive 6 months in patients with T2DM
15728392|NCT05037032|Drug|Naltrexone Pill|50 mg PO one-time only
15728393|NCT05037032|Drug|Placebo|Matching placebo for naltrexone
15728394|NCT05037019|Procedure|Radiation therapy|Women diagnosed with early stage breast cancer are given a single dose of stereotactic body radiation therapy (SBRT) prior to any other treatment in the context of delayed lumpectomy due to the COVID-19 pandemic.
15728401|NCT05036993|Behavioral|Coaching|Faculty will be paired with a certified coach who is also a faculty member and receive 6 sessions of coaching over 3 months
15728402|NCT05036980|Drug|Trans Sodium Crocetinate|Single IV bolus
15728404|NCT05036954|Device|EyeBrid Excel hybrid lenses|new lenses
15728405|NCT05036941|Device|Acteev™ Masks|Participants will wear the mask on every shift for 8 or 12 consecutive weeks. Participants in Arm 1 will be supplied adequate number of Acteev™ N95 masks YQD8008 during 8-hour shift and Acteev™ fabric masks for community use.
15728406|NCT05036941|Device|Comparison Masks|Participants will wear the mask on every shift for 8 or 12 consecutive weeks. Participants in Arm 2 will be supplied with adequate number of standard N95 masks during 8-hour shift and fabric mask for community use.
15728407|NCT05036928|Diagnostic Test|Monocyte distribution width (MDW）|All enrolled patients will receive test with MDW.
15728410|NCT05036889|Diagnostic Test|Mind.Px Report|Use of Mind.Px report as a reference for potential better matching of biologics to patients.
15728413|NCT05036863|Behavioral|Weekly questionnaires|Patients will complete weekly symptom monitoring PROMs. If a symptom exceeds the thresholds for clinical importance, a registered nurse will contact the patient, confirm the symptoms and coordinate the further clinical procedure in line with standard practice.
15728414|NCT05036837|Drug|OZOPROMAF_SEQ1|"OZOPROMAF protocol consists of: local superficial anesthesia by EMLA® cream, intra-tissue injection of a 15 ml OxigenOzone (mixture by 26Gx 1⁄2 - 0.45x13mm needle into the mucosal margin surrounding the bone exposure or around the situs already evidenced by CT scan. It is applied on 7-15 days, depending on the patient compliance, until the formation of sequestrum and clinical healing (T1).
~Pain intensity is assessed by means of a questionnaire for pain and/or other symptoms evaluation before and after the protocol, based on numerical rating scale (NRS).
~After resolution (T1), follow-up visits are scheduled to confirm the healing of MRONJ at 1 (T2), 3, 6 (T3), 12 (T4), 18- 24 months (T5).
~Radiographic evaluations of bone healing are scheduled at T3 and T4.
~Positive outcomes for the OZOPROMAF protocol are evaluated at T1 as no clinical signs of acute phlogosis and no symptoms compatible with MRONJ; at T5 as clinical healing and no radiological signs of MRONJ."
15728415|NCT05036824|Drug|tinzaparin|Daily tinzaparin administration: 8000 - 14000 Anti-Xa IU
15728416|NCT05036811|Other|data collection|data collection
15728417|NCT05036798|Drug|Tislelizumab|"Chemotherapy regimen:
~Gemcitabine 1g/m2 Oxaliplatin 100mg/m, D1, q3W2 Tislelizumab 200mg D1 Q3w Lenvatinib 4mg Po QD"
15728418|NCT05036785|Other|Timing of suture removal|Patients will either be randomized to have their sutures removed at 7 or 10 days post skin surgery
15728419|NCT05036772|Device|Virtual reality|The experimental arm will have the possibility to use a distracting virutel environment for the duration of hysterosalpingography.
15728420|NCT05036759|Drug|68Ga-FAPI|intravenously injected with 68Ga-FAPI
15728422|NCT05036733|Drug|Dupilumab|"Participants will receive 8 doses of Dupilumab. The initial loading dose (visit 1) of 600 milligrams (two 300 milligram injections) will be given subcutaneously (SQ). Then the participants will receive 300 milligrams SQ every other week (q 2 weeks) either at a study visit or self-administered at home between visits.
~Additionally, participants will complete questionnaires, have specimens collected, as well as perform breathing procedures at various timepoints."
15728423|NCT05036720|Behavioral|LTP+Dads|"LTP+Dads is a 12 - session group integrated parenting intervention which includes a pictorial calendar, consisting of stages of child development from birth to 3 years. It includes parent-child play and other activities that promote parental involvement, learning, and attachment.
~The second component of the intervention is Cognitive Behaviour Therapy (CBT) adapted from the Jeanne Miranda manual (Group CBT for Depression) focusing on three areas: thoughts and your mood, activities and your mood, people interaction and your mood.
~The third component of intervention is content taken from Ed Bader's manual (Focus on Fathers) includes importance of fathers in child development, stress management at work and home, budgeting, anger management, conflict resolution and time management."
15728424|NCT05036720|Behavioral|LTP+ Optional mother component|LTP+ is comprised of two components; Learning through play (LTP) and Cognitive Behavior Therapy (CBT). The LTP+ is a low-literacy, sustainable program intended to provide parents with information on the healthy growth and development of their young children. The LTP research-based activities enhance children's development while simultaneously promoting attachment security through building parents' ability to read and be sensitive to their children's cues and through active involvement in their children's development. Plus the Thinking Healthy Program (THP) which adopts 'here and now' problem-solving approach. THP uses cognitive behavior therapy (CBT) techniques of active listening, changing negative thinking, and collaboration with the family.
15728425|NCT05036707|Device|Xenodiagnosis Ticks|Larval ticks will be obtained from Dr. Sam Telford from a laboratory maintained tick colony at Tufts Veterinary School. These ticks are hatched from eggs laid by ticks that have fed only on specific pathogen free laboratory animals that were purchased from established vendors.
15728426|NCT05036707|Procedure|skin biopsy|2-3 mm skin punch biopsies will be performed.
15728427|NCT05036707|Procedure|blood draw|Peripheral blood draws will be performed.
15728428|NCT05036694|Device|FUJILAM KIT|Urine based test to detect LAM
15728429|NCT05036681|Drug|Futibatinib|tablets by mouth 1 time every day
15728430|NCT05036681|Drug|Pembrolizumab|Given by vein over about 30-60 minutes on Day 1 of all cycles
15728431|NCT05036668|Biological|Cryptosporidium parvum oocysts (ABO809)|ABO809 3x10^6 CE/3mL concentrate for oral suspension, single dose at Day 1
15728432|NCT05036655|Procedure|Perioperative glycemic management pathway|The PGMP is a shared-care pathway. It starts at the decision to undergo surgery, and includes preoperative planning, intraoperative management, the postoperative inpatient stay, and post-admission coordination of care to manage patients undergoing surgery based on a logic model for postoperative hyperglycemia. The PGMP identifies patients at high-risk of postoperative hyperglycemia at the time of surgical triaging using hemoglobin A1c (HbA1c) screening, based on Diabetes Canada recommendations. HbA1c screening estimates an individual's three-month average blood glucose, and is used to screen, diagnose, and titrate medications for diabetes. The PGMP then guides team members to monitor blood glucose postoperatively using POCT, and to manage hyperglycemia in high-risk patients using standardized care plans.
15728433|NCT05036642|Device|Compliant Passive Arm Support|The device is a mechanical device that consists of two linkages, elastic bands, a commercial posture brace, and a hook-and-loop fastener. The design of the device, with several compliant elements, ensures that one device fits many without joint alignment concerns. No motors or other actuators add energy into the system, meaning that it is stable.
15728434|NCT05036629|Device|MRI Protocol|"Eye-tracker Eyelink (eye movements) BIOPAC : (electrodermal resistance) INVIVO Precess : breathing, arterial pressure, pulse,
~NIRS Oxymon artinis medical system
~tES (transcranial electrical stimulation, Neuroelectrics)"
15728435|NCT05036616|Device|Combination of extracorporeal membrane oxygenation and continuous renal replacement therapy|Combination of extracorporeal membrane oxygenation and continuous renal replacement therapy
15728436|NCT05036603|Other|chest physiotherapy|diffferent chest physiotherapy methods
15728437|NCT05036590|Other|control group|The control group consisted of caregivers included during the control period, before the intervention was deployed, i.e., before the BREF program was implemented by the centers.
15728438|NCT05036590|Other|Intervention group|The intervention group consists of caregivers included during the intervention period. Caregivers in the intervention group will benefit from the BREF program.
15728443|NCT05036564|Procedure|Lumbar puncture|"A lumbar puncture (spinal tap) is performed in patient lower back, in the lumbar region.
~During a lumbar puncture, a needle is inserted between two lumbar bones (vertebrae) to remove a sample of cerebrospinal fluid (CSF). This is the fluid that surrounds brain and spinal cord to protect them from injury.
~This procedure is usually performed at the time of diagnosis for disease staging and/or repeated in the course of the disease history, only if positive or for clinical reasons (i.e. suspicious of relapse progression).
~In this study sequential CSF and peripheral blood samples of study population will be collected also at different time points, with the aim to improve diagnostics sensitivity, response assessment and monitoring early CNS relapse."
15728444|NCT05036551|Diagnostic Test|Kellgren Lawrence classification|The Kellgren Lawrence classification was used in the radiological evaluation. It is a classification method used in the staging of knee osteoarthritis. Five stages were defined according to the anteroposterior X-ray.(Stage 0-5)
15728445|NCT05036538|Device|Intervention with natural sounds administered via headphones|The preoperative intervention includes a stress-reducing relaxation phase lasting approximately 30 minutes, during which the patients are presented with nature sounds.
15728446|NCT05036538|Device|Intervention with natural sounds and binaural beats administered via headphones|The preoperative intervention includes a stress-reducing relaxation phase lasting approximately 30 minutes, during which the patients are presented with nature sounds and binaural beats.
15728447|NCT05036538|Device|Intervention with natural sounds and virtual reality administered via headphones and head mounted display|The preoperative intervention includes a stress-reducing relaxation phase lasting approximately 30 minutes, during which the patients are presented with a nature scene in a spherical 360° environment with associated nature sounds.
15728448|NCT05036538|Device|Intervention with natural sounds, binaural beats and virtual reality administered via headphones and head mounted display|The preoperative intervention includes a stress-reducing relaxation phase lasting approximately 30 minutes, during which the patients are presented with a nature scene in a spherical 360° environment with associated nature sounds and binaural beats.
15728449|NCT05036525|Device|HANBIO BarriGel|an anti-adhesive product
15728450|NCT05036512|Drug|GBT021601|Administered orally with water as a single dose in the morning.
15728451|NCT05036499|Behavioral|Personalized Feedback Intervention|Providing corrective normative feedback on alcohol use, psychoeducation on the interplay between pain and alcohol use, and providing exercises to target pain-related anxiety
15728452|NCT05036486|Genetic|next-generation sequencing|Tumor tissue will be collected from advanced BTC patients for real-time next-generation sequencing analysis
15728519|NCT05036070|Device|Model C0001|Investigational intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
15730124|NCT05023551|Drug|DSP-0390|DSP-0390 administered orally
15728453|NCT05036473|Drug|WD-1603 Carbidopa-Levodopa Extended-Release Tablets|Taking WD-1603 tablets or placebo orally three times a day, in the morning before meals, and the second and third medications will be taken after meals, once every 5 hours (±30 minutes).
15728454|NCT05036473|Drug|Placebo|placebo tablets-matching the active groups.
15728455|NCT05036460|Procedure|Ultrasonography|"The transducer will be placed over the anterior neck just above the suprasternal notch, in the transverse orientation. The position of the transducer could be adjusted to visualize both the esophagus and trachea. It will be considered as esophageal intubation if esophageal dilation or double-tract sign are noted."
15728456|NCT05036460|Procedure|Direct visualization|While performing the intubation, the intubator will report ETI if visualizing the tracheal tube passing through the glottis. Otherwise, it will be regarded as esophageal intubation.
15728457|NCT05036447|Other|Moderate-Heavy Resistance Exercise|"Leg press: 3 x 8 repetitions at 75% of 1 repetition maximum, 3 minutes rest between sets.
~Knee extension: 3 x 6 repetitions at 85% of 1 repetition maximum, 3 minutes rest between sets."
15728458|NCT05036434|Drug|Pembrolizumab / Lenvatinib|Pembrolizumab Plus Lenvatinib administration.
15728459|NCT05036421|Drug|Empagliflozin 10 MG|antihyperglycemic medication
15728467|NCT05036395|Other|The routine assessment protocol and AI-assisted cEEG Diagnostic tool|The AI-assisted cEEG diagnostic tool is an automated seizure reporting system, including a quantitively EEG neural signal processing pipeline to extract features from the original signal datasets, machine learning models based on gradient boosted model for prediction. The tool can report electrographic seizures in real time during cEEG monitoring. The neonatologists will evaluate the neonates by AI-assisted cEEG diagnostic tool, clinical conditions, real-time cEEG and amplitude-integrated EEG traces. The investigators will make a decision after review the neonates clinical conditions, AI-assisted cEEG diagnostic report, the cEEG and amplitude-integrated EEG.
15728468|NCT05036395|Other|The routine assessment protocol|The routine assessment protocol is that the neonatologists will evaluate the neonates by clinical conditions, real-time cEEG and amplitude-integrated EEG traces.
15728469|NCT05036382|Behavioral|Steps data observation|Sending more step data from the experimental group that received the incentive message
15728470|NCT05036369|Device|Vibrant capsule|The Vibrant Capsule is designed to mechanically induce a peristaltic wave in the large intestine, thus aiding in relieving constipated subjects. Constipation relief is achieved by the capsule's vibrations impinging on the gastrointestinal wall, consequently inducing peristaltic activity which promotes transit and facilitates defecation
15728471|NCT05036356|Other|Headspace App|"A mobile-application (app) focusing on teaching and sustaining mental well-being."
15728473|NCT05036330|Other|Clinical Evaluation|Undergo speech and swallow evaluation
15728474|NCT05036330|Procedure|Physical Examination|Undergo examination of TEP and laryngectomy stoma
15728475|NCT05036330|Other|Quality-of-Life Assessment|Complete questionnaires
15728476|NCT05036330|Other|Questionnaire Administration|Complete questionnaires
15728477|NCT05036317|Drug|Empagliflozin (Jardiance®;|Each tablet contains the active substance of 10 mg empagliflozin as well as the adjuvant lactose-monohydrate and is taken orally once daily in the morning.
15728478|NCT05036317|Other|Placebo Control Intervention|Placebo will be provided by Boehringer Ingelheim. It is identical to the interventional product apart from the active compound.
15728479|NCT05036304|Other|Aerobic Exercise Indoors|Each session will consist of 10 min of warm-up, 40 min of aerobic exercise, and 10 min of cool-down. Aerobic exercise will be progressive and of moderate intensity. During training, each participant will wear a heart rate monitor and will be asked to work initially at approximately 45% of his/her target heart rate (i.e., heart rate reserve (HRR)) and gradually progress to reach the target of 70% of HRR over the 12-week study period. Participants will also subjectively monitor workout intensity using the 20-point Borg's Rating of Perceived Exertion. Participants will walk or jog on treadmills or cycle on stationary bikes in the Exercise Prescription Suite of the Centre for Hip Health and Mobility.
15728480|NCT05036304|Other|Aerobic Exercise Outdoors|Each session will consist of 10 min of warm-up, 40 min of aerobic exercise, and 10 min of cool-down. Aerobic exercise will be progressive and of moderate intensity. During training, each participant will wear a heart rate monitor and will be asked to work initially at approximately 45% of his/her target heart rate (i.e., heart rate reserve (HRR)) and gradually progress to reach the target of 70% of HRR over the 12-week study period. Participants will also subjectively monitor workout intensity using the 20-point Borg's Rating of Perceived Exertion. Participants will walk or jog pre-determined routes in trails of an urban forest (Pacific Spirit Park)
15728482|NCT05036278|Biological|Damoctocog alfa-pegol (Jivi, BAY94-9027)|"Dosage Levels:
~40 IU/kg/dose two times per week
~50 IU/kg/dose every 5 days, total recommended maximum dose/infusion is 6000 IU
~60 IU/kg/dose, Less frequent dosing (e.g. every 7 days), the total recommended maximum dose/infusion is 6000 IU."
15728483|NCT05036252|Diagnostic Test|Cardiopulmonary Exercise Test|All enrolled participants will undergo a cardiopulmonary exercise test (CPET). The CPET will be conducted using an electronic motorized treadmill with 12-lead ECG monitoring performed by ACSM-certified exercise physiologists.
15728576|NCT05035654|Drug|LYR-220 Design 2|LYR-220 drug matrix (mometasone furoate 7500 µg) Design 2
15728484|NCT05036252|Diagnostic Test|Echocardiogram|Resting assessment of LVEF and GLS will be evaluated through Conventional 2D and Doppler echocardiograms will be performed per protocol using a commercially available ultrasound scanner, according to the American Society of Echocardiography (ASE) recommendations for a comprehensive examination.
15728485|NCT05036252|Diagnostic Test|Echocardiography|As soon as possible following completion of the CPET, subjects will be placed in the supine position and 2D echocardiographic images will be obtained in the apical 4-/ 3-/2-chamber views.
15728486|NCT05036239|Other|Eccentric biceps curls|10 x 5 repetitions of eccentric biceps curls, interspaced by 30 seconds of rest.
15728487|NCT05036226|Combination Product|Hydroxychloroquine, Metformin, Sirolimus|Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily
15728488|NCT05036226|Combination Product|Hydroxychloroquine, Metformin, Sirolimus, Dasatanib|Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily Dasatinib 20mg daily
15728489|NCT05036226|Combination Product|Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir|Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily Nelfinavir 1250mg twice daily
15728490|NCT05036226|Combination Product|Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir, Dasatinib|Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily Nelfinavir 1250mg twice daily Dasatanib 20mg daily
15728491|NCT05036226|Combination Product|Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir|Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily Nelfinavir 2500mg twice daily
15728492|NCT05036226|Combination Product|Hydroxychloroquine, Metformin, Sirolimus, Nelfinavir, Dasatinib|Hydroxychloroquine 600mg twice daily Metformin 500mg daily for 7 days, then increase to 1000mg daily Sirolimus 0.5mg daily Nelfinavir 2500mg twice daily Dasatanib 20mg daily
15728493|NCT05036213|Drug|BEET IT - Concentrate Beet root juice|Each bottle contains 75ml of concentrated beetroot juice with approximately 6.2mmol of inorganic nitrate. The product is provided by BEET IT, James White Drinks, Ipswich, UK.
15728494|NCT05036213|Drug|BEET IT - Concentrate Beet root juice (nitrate depleted)|Each bottle contains 75ml of concentrated beetroot juice with depleted nitrate, thus, no inorganic nitrate is found in thisbeverage. The product is also provided by BEET IT, James White Drinks, Ipswich, UK.
15728495|NCT05036200|Device|pulsed dye laser|four pulsed dye laser sessions were administered every eight weeks in the 21 patients
15728496|NCT05036187|Behavioral|Behavioral Weight Loss Intervention|Rx Weight Loss: PRIDE is a fully automated online behavioral obesity treatment that is tailored for sexual minority women and involves viewing 12 online video lessons delivered each week, self-monitoring body weight, calorie intake, and physical activity levels, and receiving personalized automated weekly feedback on progress toward goals.
15728497|NCT05036187|Behavioral|Minority Stress Intervention|The Minority Stress Intervention is designed to help sexual minority women cope with stress and stigma (e.g., due to weight, sexual orientation, gender). In this program, participants watch online video lessons that teach cognitive and behavioral strategies for coping with minority stress so that it may have less of an influence on participants' weight and well-being.
15728498|NCT05036187|Behavioral|Negative Body Image Intervention|The Negative Body Image Intervention is designed to help participants improve their body image. In this program, participants will watch online video lessons that provide education on queer women's body image and teach cognitive and behavioral strategies for improving your body image (regardless of your weight) to reduce its influence on your health.
15728499|NCT05036187|Behavioral|Social Support Intervention|The Social Support Intervention provides online opportunities for participants to receive more social support as they work toward their weight loss goals. Participants receive education on the importance of social support for weight management, they can earn badges for completing program milestones, and they gain access to a private online forum to get support and advice from other participants.
15728500|NCT05036174|Drug|Diphenhydramine 5%|Diphenhydramine 5% ointment
15728501|NCT05036174|Drug|Placebo|Placebo matched to diphenhydramine 5% ointment
15728502|NCT05036161|Other|Nasal high flow|Newborns with respiratory distress treated with NHF.
15728503|NCT05036161|Other|Continuous Positive Airway Pressure|Newborns with respiratory distress treated with CPAP.
15728504|NCT05036148|Other|Data analysis|MH registry data will be screened for MH positive diagnosis
15728505|NCT05036135|Drug|AV-101|AV-101 (imatinib) administered via dry powder inhalation
15728506|NCT05036135|Drug|Placebo|Placebo administered via dry powder inhalation
15728507|NCT05036122|Device|LabClasp|Non-invasive device that estimates blood [lactate] from interstitial fluid via a proprietary algorithm. The device is placed between the first and second knuckle of a finger and gently applies slight pressure to extract interstitial fluid from the skin. Sensors within the device quickly estimate blood [lactate] and return a value to the subject via an accompanying tablet within 20 seconds.
15728508|NCT05036109|Drug|Aspirin|by mouth every day for up to 90 days
15728509|NCT05036109|Drug|Vitamin D|by mouth every day for up to 90 days
15728510|NCT05036109|Dietary Supplement|Diet|Patients will receive counseling promoting a plant-based diet and avoidance of Western dietary patterns in a one on one session with a licensed dietitian prior to day 1.
15728511|NCT05036109|Other|Physical Activity|The exercise goal is to increase recreational physical activity from baseline by at least 10 MET hours per week, which is equivalent to 150 minutes of moderate activity weekly
15728512|NCT05036109|Behavioral|Behavioral Support Counseling Sessions|Patients will undergo a one-on-one counseling session prior to day 1
15728515|NCT05036083|Procedure|Contrast-Enhanced Mammography|Undergo CEM
15728516|NCT05036083|Procedure|Digital Tomosynthesis Mammography|Undergo DBT
15728517|NCT05036083|Other|Electronic Health Record Review|Medical records reviewed
15728518|NCT05036083|Drug|Iodinated Contrast Agent|Given IV
15728520|NCT05036070|Device|Model ZCB00|Control intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
15728521|NCT05036057|Other|Questionnaire|"Patients will do the Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD), the COPD Assesment Test (CAT), the Saint George Respiratory Disease Questionnaire (SGRQ), the Charlson Comorbidity Index, and will rate the disease and general knowledge level on a numerical scale.
~Proxies of patients will do the Individual Knowledge Statement Questionnaire of Chronic Obstructive Pulmonary Disease (COPD) and will rate the disease and general knowledge level on a numerical scale."
15728522|NCT05036018|Device|ACURATE neo2|The ACURATE neo2 valve will be implanted using a two-step mechanism during transfemoral transcatheter aortic valve implantation (TAVI). Balloon predilatation will be recommended in the ACURATE neo 2 valve group.
15728523|NCT05036018|Procedure|Isolated local anesthesia|Local anesthesia will be performed by injecting Lidocaine into the skin, subcutis, and around the femoral artery.
15728524|NCT05036018|Device|CoreValve Evolut Pro and Pro+|The Evolut Pro or Pro+ valve is positioned in a controlled manner either without pacing or under 'slow-rapid' pacing with allowance for limited repositioning and is anchored to the annulus and ascending aorta.
15728525|NCT05036018|Procedure|local anesthesia with conscious sedation|For conscious sedation remifentanil, Propofol and dexmedetomidine (alone or in combination) are allowed within a local/institutional standard operating procedure using EEG monitoring. Continuous CO2-monitoring via face mask should be established during sedation and all patients will receive supplemental oxygen by face mask. Local anesthesia will be performed by injecting Lidocaine into the skin, subcutis, and around the femoral artery.
15728526|NCT05036005|Drug|Ontruzant|All patients will receive an initial dose of Ontruzant® i.v. 8 mg/kg b.w in combination with standard chemotherapy with or without pertuzumab i.v. 480 mg followed by 5 cycles of Ontruzant® i.v. 6 mg/kg b.w. q21d in combination with standard chemotherapy with or without pertuzumab i.v. 420 mg. Addition of pertuzumab is at the discretion of investigator's decision.
15728527|NCT05036005|Drug|Chemotherapy|All patients will receive an initial dose of Ontruzant® i.v. 8 mg/kg b.w in combination with standard chemotherapy with or without pertuzumab i.v. 480 mg followed by 5 cycles of Ontruzant® i.v. 6 mg/kg b.w. q21d in combination with standard chemotherapy with or without pertuzumab i.v. 420 mg. Choice of chemotherapy is at the discretion of the investigator
15728528|NCT05036005|Drug|Pertuzumab|All patients will receive an initial dose of Ontruzant® i.v. 8 mg/kg b.w in combination with standard chemotherapy with or without pertuzumab i.v. 480 mg followed by 5 cycles of Ontruzant® i.v. 6 mg/kg b.w. q21d in combination with standard chemotherapy with or without pertuzumab i.v. 420 mg. Addition of pertuzumab is at the discretion of investigator's decision.
15728529|NCT05035979|Drug|BaidI Quzhi granule|Put each bag of medicine in one day into the same container, pour in about 50ml of warm water, stir until the granules are basically dissolved, add some boiled water to dilute, and take it twice.
15728530|NCT05035979|Drug|Ju Yin cream|Take JY cream 5g evenly applied to the face, negative ion spray at the same time acupoint massage along the meridian, apply 10min, clean the face with water, 3 times a week.
15728531|NCT05035979|Drug|Baidi Quzhi placebo granule|Put each bag of medicine in one day into the same container, pour in about 50ml of warm water, stir until the granules are basically dissolved, add some boiled water to dilute, and take it twice.
15728532|NCT05035979|Drug|Ju Yin placebo cream|Take JY placebo cream 5g evenly applied to the face, negative ion spray at the same time acupoint massage along the meridian, apply 10min, clean the face with water, 3 times a week.
15728533|NCT05035966|Other|Plasma β-amyloid 40 and 42 concentration|Plasma β-amyloid 40 and 42 concentrations were simultaneously measured by validated assay platforms from Meso Scale Discovery (MSD; Rockville, MD, USA).
15728534|NCT05035953|Drug|Edaravone Dexborneol|Edaravone Dexborneol 37.5 mg (containing Edaravone 30 mg and Dexborneol 7.5 mg), BID, 14 days, addition to thrombolysis
15728535|NCT05035953|Drug|Placebo|Edaravone Dexborneol matching injection, addition to thrombolysis
15728536|NCT05035927|Drug|TRYP-0082|TRYP-0082 will be administered in conjunction with psychotherapy in subjects with overeating disorders including but not limited to hypothalamic obesity, binge-eating disorder, and Prader-Willi Syndrome, as assessed by maximum change from baseline in body mass index at 8 weeks following the second of 2 doses. Two oral doses of psilocybin will be administered two weeks apart, ±1 day, at Week 2 and Week 4 visit. The first dose will be 25 mg. The second dose will be determined by the Safety Review Committee (SRC) based upon combined results of safety, the MEQ30 and MRS from the first dose, patient consent, and input from the PI and Monitors. The second dose may be the same or higher than the initial dose, with an allowable increase to 0.45 mg/kg (rounded to the nearest 5 mg increment), not to exceed an absolute maximum of 50 mg. Oral psilocybin will be provided in 5 and 25 mg capsules to achieve the desired dose.
15728537|NCT05035927|Behavioral|Psychotherapy|TRYP-0082 will be administered in conjunction with psychotherapy in subjects with overeating disorders including but not limited to hypothalamic obesity, binge-eating disorder, and Prader-Willi Syndrome, as assessed by maximum change from baseline in body mass index at 8 weeks following the second of 2 doses. Two oral doses of psilocybin will be administered two weeks apart, ±1 day, at Week 2 and Week 4 visit. The first dose will be 25 mg. The second dose will be determined by the Safety Review Committee (SRC) based upon combined results of safety, the MEQ30 and MRS from the first dose, patient consent, and input from the PI and Monitors. The second dose may be the same or higher than the initial dose, with an allowable increase to 0.45 mg/kg (rounded to the nearest 5 mg increment), not to exceed an absolute maximum of 50 mg. Oral psilocybin will be provided in 5 and 25 mg capsules to achieve the desired dose.
15728538|NCT05035914|Drug|Anlotinib Hydrochloride|Anlotinib Hydrochloride is a capsule in the form of 8 mg ,10 mg and 12 mg, orally, once daily, 2 weeks on/1 week off.
15728539|NCT05035901|Other|visual-perception motor-coordination integration program|Visual-perception motor-coordination integration program (CCVPMCI) is a Chinese characteristic-based VMI-focused program involving the most Chinese-handwriting-related skills training. CCVPMCI mainly emphasizes the training role of visual-motor integration. The idea of CCVPMCI program will involve (1) visual motor integration training affiliated with visual perception and motor coordination as warm-up exercise, (2) more focus on visual spatial perception in connect with unique visual structure of Chinese characters, (3) the trace or component elements of Chinese characters as the interesting practice material and (4) appropriate challenge for learning.
15728572|NCT05035680|Biological|SWE adjuvant mixed with unadjuvanted seasonal influenza vaccine shortly before dosing (SWE + QIV)|Single 0.8 mL IM injection
15728573|NCT05035680|Biological|MF59 adjuvanted seasonal influenza vaccine|Single 0.5 mL IM injection of MF59 adjuvanted seasonal influenza vaccine
15728540|NCT05035888|Drug|Phenylephrine|An initial prophylactic bolus dose of phenylephrine (37.5μg) simultaneous with spinal anesthesia. If the patient did not respond adequately to the current dose (SBP decreased to < 80% of baseline), the dose was considered to have failed and the subsequent dose for the following patient was increased to the next higher dose level. The dose administered to subsequent patients varied by increments or decrements of 12.5 μg according to the responses of previous patients according to the up-down sequential allocation.
15728541|NCT05035888|Drug|Norepinephrine|An initial prophylactic bolus dose of norepinephrine (3μg) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 1 μg according to the responses of previous patients according to the up-down sequential allocation.
15728542|NCT05035875|Device|ultrasonography|ultrasound assessment of diaphragm function
15728543|NCT05035862|Drug|Albuterol Sulfate|Participants who experience symptoms of cough, dyspnea, chest tightness or wheezing will initiate use of albuterol (2 inhalations, 90 mcg/actuation) by metered dose inhaler (MDI) every 20 minutes for up to 1 hour and then every 4 hours if necessary.
15728544|NCT05035862|Drug|Interferon gamma-primed mesenchymal stromal cells (MSCs)|IFNγ-primed bone marrow MSCs at a dose level of 2x106 cells/kg and a dose level of 5x106 cells/kg
15728545|NCT05035862|Drug|Prednisone|Prednisone is recommended if the participant uses more than 12 inhalations of albuterol in 24 hours (excluding preventive use before exercise), or if the patient has ongoing symptoms for 48 hours or longer. The recommended prednisone dose for acute exacerbations is 2 mg/kg/day (maximum 60 mg) as a single dose for two days followed by 1 mg/kg/day (maximum 30 mg) as a single dose for two days. All administered doses will be rounded down to the nearest 10 mg.
15728546|NCT05035849|Drug|sitagliptin and acarbose|One group used first sitagliptin and metformin, then used acarbose and metformin. Another group used first acarbose and metformin, then used sitagliptin andmetformin.
15728547|NCT05035836|Drug|Zanidatamab|Given IV
15728548|NCT05035836|Drug|Letrozole|Given by PO
15728549|NCT05035836|Drug|Tamoxifen|Given by PO
15728550|NCT05035823|Device|Motor Neuroprosthesis (MNP)|Type of implantable brain computer interface
15728551|NCT05035810|Behavioral|Social Incentives and Gamification to Promote Exercise|The intervention will provide social incentives and gamification to promote physical activity.
15728552|NCT05035810|Drug|Corticosteroid Injection given in A-B order|The study will compare corticosteroid injections with lidocaine to lidocaine only in a crossover design. These participants will receive the medication in A-B order.
15728553|NCT05035810|Behavioral|No Social Incentive applied|No social incentive will be applied
15728554|NCT05035810|Drug|Procedure: Corticosteroid Injection given in B-A order|The study will compare corticosteroid injections with lidocaine to lidocaine only in a crossover design. These participants will receive the medication in B-A order.
15728555|NCT05035797|Procedure|Cardiopulmonary rehabilitation|Cardiopulmonary rehabilitation program which encompasses six evidence-based components according to literature review: 1) positioning; 2) passive range of motion (PROM) training; 3) neuromuscular electronic stimulation (NMES); 4) surface electrical phrenic nerve stimulation (SEPNS); 5) PNF techniques; and 6) airway clearance techniques; Usual care normally comprises pharmacotherapy, mechanical ventilation, continuous renal replacement therapy (CRRT), intra-aortic balloon pump (IABP), and specific nursing for ECMO therapy and their original injuries, as appropriate.
15728556|NCT05035797|Procedure|Usual care|Control group will be treated with usual care and ECMO therapy. Usual care normally comprises pharmacotherapy, mechanical ventilation, continuous renal replacement therapy (CRRT), intra-aortic balloon pump (IABP), and specific nursing for ECMO therapy and their original injuries, as appropriate.
15728557|NCT05035784|Drug|Fecal supernatant|Fecal supernatant from a child registered in the specimen bank that matches the subject's age, gender, and weight .
15728558|NCT05035784|Drug|Placebo|a placebo designed to match the FMT+RCE group based on appearance including 0.9% physiological saline.
15728559|NCT05035771|Device|Pressure wire measurement in peripheral vascular disease|The aim of IMPACT PAD is to examine the safety and feasibility of intraprocedural flow, pressure and resistance rate changes to help predict the success of a peripheral endovascular intervention.
15728560|NCT05035758|Other|Transcendental Meditation|"In the beginning, the patients from group B will receive an introductory lecture about transcendental meditation (TM) which includes general information, the procedure itself and other techniques of relaxation and personal development.
~In this first session the method is learned by practice, in the following 3 meetings additional instructions are given about the correct practice of the TM technique; TM is practiced twice a day for 20 minutes. The method is easy to learn and effortless. To guarantee the right performance of TM by the patients, there will be two group meetings per week and one individual personal meeting with the TM teacher.After discharge from the rehabilitation program (after 4 weeks) there will be meetings offered according to the patients need. This will then be arranged individually."
15728561|NCT05035758|Other|Yoga|"In addition to the standard rehabilitation exercise training, the patients in this group will receive a 20-minute workshop where they learn how to do the yoga exercise. The initial yoga workshop will be held by Dr. Gilda Wüst who is a yoga expert with a lot of experience based in St. Radegund.
~After this, yoga sessions will be included (additionally to the regular/standard exercise) into their daily timetable. Two yoga sessions will be done every day, one in the morning (6:30-6:50) and one in the evening (16:30-16:50) and will last for about 20 minutes."
15728562|NCT05035745|Drug|Talazoparib|Patients will be treated with Talazoparib daily on a 4 weekly cycle (28 days)
15728563|NCT05035745|Drug|Selinexor|Patients will be treated with Selinexor once per week (3 out of 4 weeks), on a 4 weekly cycle (28 days)
15728564|NCT05035732|Radiation|18F-fluciclovine|IV
15728565|NCT05035719|Device|non-invasive cardiac output monitor|Equivalence of Caretaker cardiac output reading to reference standard
15728566|NCT05035706|Procedure|Biopsy|Undergo biopsy
15728567|NCT05035706|Procedure|Biospecimen Collection|Undergo blood and tissue sample collection
15728568|NCT05035706|Other|Electronic Health Record Review|Medical records reviewed
15728569|NCT05035706|Other|Photography|Photographs taken
15728570|NCT05035693|Device|MOVE®-C|Momo- or bisegmental implantation of MOVE®-C cervical prothesis.
15728571|NCT05035680|Biological|Unadjuvanted seasonal influenza vaccine|Single 0.5 mL IM injection
15728574|NCT05035667|Other|Questionnaire Administration|Complete questionnaires
15728577|NCT05035641|Drug|AND017|Orally, 3 times per week in Period 1 and randomize to TIW or QW group at the same dose in Period 2
15728578|NCT05035641|Drug|Placebo|Orally, 3 times per week
15728579|NCT05035628|Other|Cardiopulmonary exercise training|"Participants will follow a 2-month exercise training program, thrice-weekly trainings. The training sessions will start with a 5-min warmup, followed by an aerobic training (20 min) after which 20-min of resistance/muscular training will take place. The program will end with respiratory exercises and cool down period (10 min). Training will be adapted to individuals' baseline capacity as measured by the baseline cardiorespiratory test.
~A certified kinesiologist will supervise trainings. Heart rate, oxygen saturation and rating of perceived exertion (Borg Scale, 6-20) will be measured during training sessions."
15728581|NCT05035602|Other|Physical activity assessment|Physical activity patterns will be obtained from google location history, using an Android phone
15728582|NCT05035589|Drug|Tocilizumab|Tocilizumab administered at a dose of 8mg/kg up to a maximum of 800mg
15728583|NCT05035576|Drug|OPN-019|400 mg OPN-019, 2 sprays per nostril (one dose)
15728584|NCT05035563|Behavioral|Intervention. Early and integral communication strategy (EICS)|"This intervention will be implemented in patients since they are hospitalized in the ICU where is expected:
~Facilitate contact and communication between patients, families and the health team.
~Respond to the communication needs of family members.
~Reduce equipment overload and facilitate communication with families and patients, providing tools and timely support.
~Build a positive and trusting relationship of relatives and patients with health teams.
~The intervention considers the following actions:
~- Training in communication to the health team
~- Written material
~- Family website
~- Standardized and daily telephone information
~- Health Team Support Strategy
~- Weekly multidisciplinary virtual meeting with the family
~- ICU diaries for family members"
15728585|NCT05035550|Behavioral|Non-Deceptive Placebo|"The placebos were ordered through Amazon from Zeebo® (Zeebo, Zeebo Effect, LLC, South Burlington, Vermont, USA). The placebos in this study were blue and white capsules containing Microcrystalline cellulose (an inert fiber). Ingredients include ones that are typically used to make pills including silica, gelatin, titanium dioxide, red #3 food coloring, and blue #1 food coloring. Placebo capsules were free of any active ingredients. These bottles were not branded specifically for the experiment, including the brand name (Zeebo Relief), description of the contents, directions, and a disclaimer. The investigators chose to not include a custom label for transparency and in order to increase non-deceptive placebo effects. Participants were instructed to take two pills a day, one in the morning and one in the evening."
15728586|NCT05035537|Procedure|PGDT|The minimally invasive continuous CI monitor (Edwards ClearSight) was used to guide an optimization of preload with the use of algorithms based on fluids, inotropes and/or vasopressors to achieve a certain goal in medium arterial pressure (MAP), cardiac index (CI) and stroke volume variation (SVV)
15728587|NCT05035524|Drug|Sodium Bicarbonate Solution|Inhalation of SB 8.4% via a jet nebulizer (5 ml every 4 h) starting at 7:00 to 23:00 hours every day for 30 days together with instillation of SB 8.4% drops 4-times daily (three drops for each nostril) were offered to all patients in the study group (El-Badrawy et al., 2019).
15728588|NCT05035524|Drug|Placebo|Placebo
15728589|NCT05035511|Device|tDCS|Active-tDCS over 10 sessions in 2 weeks (once per day, for 10 consecutive working days), while performing the executive function training tasks. Also, participants will complete an online cognitive training program while they receive active tDCS stimulation for 10 training sessions. The training session will last for 20 minutes and the online cognitive training program is comprised of 5 exercises targeting at information processing speed and executive function capacities. Each exercise lasts for approximately 4 minutes, totaling approximately 20 minutes.
15728590|NCT05035498|Drug|Phenylephrine|A maintenance dose of phenylephrine (0.625 μg/kg/min) infusion simultaneous with subarachnoid block
15728591|NCT05035498|Drug|Norepinephrine|A maintenance dose of norepinephrine (0.05 μg/kg/min) infusion simultaneous with subarachnoid block
15728592|NCT05035485|Drug|Phenylephrine|A rescue phenylephrine (75μg) was given when postspinal anesthesia hypotension occurred within 30 minutes after spinal anesthesia
15728593|NCT05035485|Drug|Norepinephrine|A rescue norepinephrine (6μg) was given when postspinal anesthesia hypotension occurred within 30 minutes after spinal anesthesia
15728594|NCT05035472|Drug|Phenylephrine|An initial prophylactic bolus dose of phenylephrine (37.5μg) simultaneous with spinal anesthesia. If the patient did not respond adequately to the current dose (SBP decreased to < 80% of baseline), the dose was considered to have failed and the subsequent dose for the following patient was increased to the next higher dose level. The dose administered to subsequent patients varied by increments or decrements of 12.5 μg according to the responses of previous patients according to the up-down sequential allocation.
15728595|NCT05035472|Drug|Norepinephrine|An initial prophylactic bolus dose of norepinephrine (3μg) simultaneous with spinal anesthesia. The dose administered to subsequent patients varied by increments or decrements of 1 μg according to the responses of previous patients according to the up-down sequential allocation.
15728598|NCT05035446|Procedure|single-incision plus one-port laparoscopic surgery|The investigators use the technique of adding one operation hole on the basis of single-port laparoscopy in some patients.
15728599|NCT05035446|Procedure|conventional laparoscopic surgery|It usually requires 5 perforations ports and an auxiliary small incision to perform laparoscopic gastrectomy.
15728633|NCT05035238|Biological|Triple dose vaccination by inactivated Covid19 vaccine|triple dose intramuscular vaccine on Day 0, Day 28, and Day 120.
15728600|NCT05035433|Procedure|First lithotripsy and then EPBD|After successful selective bile duct intubation, contrast agent was injected to measure the thickness of the bile duct and the size of bile duct stones under fluoroscopy. For those meeting the inclusion criteria, sphincterotomy was performed first.Papillary sphincter incision after indwelling godet in bile duct, anti-popular character silk will be crushed stone on top into rubble after biliary tract, broken line to suitable size after the switch to expanding balloon EPBD and further kidney stones, papillary sphincter incision after indwelling godet in bile duct, anti-popular character silk will be crushed stone on top into rubble after biliary tract, broken balloon to suitable size after the switch to expansion, expansion size 10-12 mm, according to the lower bile duct diameter, expansion time of 30 seconds.Then, the stones were removed with a net basket or balloon, and the nasobiliary duct was placed to end the operation.
15728601|NCT05035433|Procedure|First EPBD and then lithotripsy|After puncture of the papillary sphincter, the guide wire was indwelled in the bile duct, and the columnar dilating balloon was inserted in exchange. The dilation size was 10-12mm, and the dilation time was 30 seconds according to the diameter of the lower end of the bile duct.At the end of the expansion, the stones were broken to a suitable size using a one-piece gravel net basket.The calculi were removed by using a stone net basket or balloon, and the nasobiliary duct was placed to end the operation.
15728612|NCT05035394|Procedure|Cataract surgery|Cataract Surgery in a standardized fashion
15728613|NCT05035394|Procedure|KDB|Goniotomy with KDB glide will be performed at the end of Cataract Surgery
15728614|NCT05035394|Procedure|Istent|Two iStent inject W will be injected into Schlemms Canal at the end of Cataract Surgery
15728615|NCT05035381|Drug|Pembrolizumab (PD-1 Inhibitor) Combined With Bevacizumab and FOLFIRI Regimen|MSI-H colorectal cancer, recurrence and metastasis within 1 year after surgery, or failure of first-line oxaliplatin and fluorouracil chemotherapy for advanced colorectal cancer, PD-1 inhibitors combined with bevacizumab and FOLFIRI regimen
15728616|NCT05035368|Drug|Ladarixin|Ladarixin will be administered orally at the dose of 400 mg twice a day at about 12-hour interval (morning and evening).
15728617|NCT05035368|Other|Placebo|Placebo is administered with the same schedule of Ladarixin.
15728618|NCT05035355|Procedure|a weaning protocol|a weaning protocol that is combined spontaneous breathing trial (SBT) with the high-flow nasal cannula (HFNC)
15728619|NCT05035342|Biological|Fecal Microbiota Transplantation (FMT) capsules|Donated fecal matter will be sequentially diluted in 80% glycerol used as bacterial cryoprotectant, blenderized, sieved and centrifuged (4°C, 4000 tr/min, 20 min). The pellet is resuspended and manually pipetted into size 0 capsules (650 μL), which are closed and then secondarily sealed in size 00 capsules (hypromellose capsules, DR caps from Capsugel®, MA). Each capsule contains 1g ± 0,1g of fecal suspension corresponding to 0.5 to 0.8g of native stool. Capsules will be stored frozen at -80°C for up to 12 months pending use. The stability of biodiversity and viability of the frozen microbiota was regularly verified to ensure the efficacy of the transplantation (personal data).
15728620|NCT05035342|Biological|Placebo capsules|"The placebo FMT capsules will be performed with the final dilution solution, ie the 80% glycerol solution used as a cryoprotectant. This solution will be double encapsulated like the FMT capsules."
15728621|NCT05035329|Other|Outcome measurements|Outcome measurements were applied.
15728622|NCT05035316|Drug|acetylsalicylic acid|Oral tablet: acetylsalicylic acid,150 mg, 1 tablet/day
15728623|NCT05035316|Drug|Calcium|Oral tablet: calcium, 1 tablet/day
15728624|NCT05035303|Procedure|Nor-Epinephrine injection versus saline during PCNL|The PCNL tract is infiltrated by Nor-Epinephrine or Normal Saline before its dilatation.
15728625|NCT05035290|Device|Negative pressure ventilation|Negative pressure ventilation - cuirass will be applied on the patient´s ches and abdomen immediately after extubation
15728626|NCT05035277|Drug|Acetylsalicylic acid|Acetylsalicylic acid 75 mg once daily is the current standard-of-care in TAVI patients without other indications for anticoagulation therapy.
15728627|NCT05035277|Drug|Apixaban|Standard dose apixaban will be one of the options for the patients in the experimental arm.
15728628|NCT05035277|Drug|Rivaroxaban|Standard dose rivaroxaban will be one of the options for the patients in the experimental arm.
15728629|NCT05035277|Drug|Edoxaban|Standard dose edoxaban will be one of the options for the patients in the experimental arm.
15728630|NCT05035264|Device|Laryngeal mask insertion|Laryngeal mask insertion in neutral position
15728631|NCT05035264|Device|Laryngeal mask insertion|Laryngeal mask insertion in sniffing position
15728632|NCT05035264|Device|Laryngeal mask insertion|Laryngeal mask insertion in beyond sniffing position
15728637|NCT05035199|Behavioral|Spiritual Distress and Resources Questionnaire (SDRQ)|The SDRQ is a validated self-rating instrument to assess spiritual distress and resources. It focuses on beliefs, attitudes, experiences and practices of various kinds (every day and extraordinary), as well as on (dis-)connectedness. It consists of 22 items covering three subscales: spiritual resources, spiritual distress, and spiritual coping (Peng-Keller et. al., 2020, submitted). We constructed five additional questions to find out more why patients want to include spiritual aspects in their treatment.
15728638|NCT05035186|Drug|Amoxicillin|Anti-H. pylori regimens
15728642|NCT05035147|Drug|albumin-bound paclitaxel|Experimental:Albumin-bound paclitaxel combined with gemcitabine was administered on the first and eighth day, a cycle of three weeks Active Comparator: Albumin-bound paclitaxel combined with gemcitabine was administered on the first, eighth, and fifteenth days, with a four-week cycle
15728643|NCT05035121|Dietary Supplement|milk supplement|Intervention groups provided 200 mL long life milk two times per day at morning and afternoon. The participants joined the resistance exercise training program, three times per week (30 min/time)
15728644|NCT05035121|Dietary Supplement|soy milk supplement|Intervention groups provided 200 mL long life soy milk two times per day at morning and afternoon. The participants joined the resistance exercise training program, three times per week (30 min/time)
15728645|NCT05035121|Behavioral|resistance exercise|The participants joined the resistance exercise training program, three times per week (30 min/time)
15728646|NCT05035108|Biological|hiHep bioartificial liver therapy|HiHep cell bioartificial liver treatment was performed 24-48 hours after extensive hepatectomy. Temporary hemodialysis tube for large vein (jugular vein or femoral vein) is indwelled before treatment. Before treatment, prepare hiHeps-BAL in a biological safety cabinet that meets clinical standards, connect the corresponding tubing to the Jianfan DX-10 blood purification machine, and prefill with heparin saline. Half an hour before treatment, the patient was pre-heparinized (heparin about 600iu) and dexamethasone to prevent allergic reactions. The patient enters the ICU, the monitor is connected to the corresponding pipeline, the arterial pump 120-160ml/min, the slurry pump 30-40ml/min, the circulating pump 75-100ml/min, the duration is 6-9h.
15728651|NCT05035069|Drug|Ciprofol|Ciprofol infusion, starting with 0.8 ~ 1mg/kg/h until BIS value below 60 (including 60), and then 0.2 ~ 0.6mg/kg/h until the end of the operation, ciprofol infusion was adjusted to keep the BIS value between 40-60.
15728652|NCT05035069|Drug|Propofol|Propofol infusion, starting with 4 ~ 5mg/kg/h until BIS value below 60 (including 60), and then 1 ~ 3mg/kg/h until the end of the operation, propofol infusion was adjusted to keep the BIS value between 40-60.
15728653|NCT05035056|Device|CT Coronary Angiogram (CTA)|Participants (150 from IMT group and 150 from UC group) will undergo CTA at the Year 3 follow-up visit at their respective enrollment study sites. Quantitative characterization of plaque analysis will be conducted at Cedars-Sinai Medical Center using Autoplaque plaque analysis software.
15728654|NCT05035043|Other|Determination of the economic burden NAFLD patients|Determination of the economic burden NAFLD patients (Healthcare costs, patient costs, burden of disease
15728655|NCT05035030|Drug|Odevixibat|Odevixibat is a small molecule and selective inhibitor of IBAT.
15728656|NCT05035004|Device|Post exercise hot water immersion|Participants will complete 30 minutes of cycling on a lode bicycle ergometer (50% of VO2max), followed by a 10-minute transfer period and then 30 minutes of whole-body hot water immersion in a hot tub (water temperature 40°C).
15728657|NCT05035004|Device|Exercise|Participants will complete 30 minutes of cycling on a lode bicycle ergometer (50% of VO2max).
15728658|NCT05035004|Device|Hot water immersion|Participants will complete 30 minutes of whole-body hot water immersion in a hot tub (water temperature 40°C), followed by a 10-minute transfer period and then an additional 30 minutes of whole-body hot water immersion in a hot tub (water temperature 40°C).
15728659|NCT05034978|Other|no intervention|evaluating the performance of a novel point-of-care test
15728660|NCT05034965|Drug|hyaluronic acid filler injection|quantitative surface electromyography before injection(baseline) and one week after injection
15728665|NCT05034939|Device|FLEX Vessel Prep System|"The FLEX Vessel Prep System™ is an over-the-wire sheathed catheter with a three-strut treatment element near the distal tip. As the device is pulled back in a retrograde fashion through the target lesion, the Treatment Element flexes providing continuous engagement along the lesion to create controlled depth micro-incisions."
15728666|NCT05034939|Device|Angioplasty|The brand and type of PTA balloon(s) used will be at the discretion of the treating physician and used according to its Instructions for Use (IFU). PTA balloons consist of an over-the-wire catheter with a balloon fixed at the distal tip. Within the lesion the balloon is inflated to a pressure that allows full effacement.
15728667|NCT05034913|Other|Digital photography measurments|"The participant will be instructed to take off any thick outer layers and leave on shirt and pants. Tops will be gathered to make cloth tight to body. The participant will stand next to an 8 ½ x 11 piece of paper taped to a wall, to use as a reference for linear regression calculations."
15728668|NCT05034900|Other|Chest physiotherapy|Programme will include diaphragmatic breathing exercise, thoracic expansion exercises, postural drainage and coughing techniques.
15728669|NCT05034900|Device|Oscillatory Positive Expiratory Pressure (OPEP) device|Shaker® device will be used.
15728670|NCT05034887|Drug|Trastuzumab Deruxtecan (T-DXd)|T-DXd will be administered at a dose of 6.4 mg/kg (decimal) by intravenous infusion every 21 days (3 weeks) for subsequent three cycles.
15728673|NCT05034861|Device|cCTG|Self-applied home computerized CTG device used twice weekly instead of standard Doppler assessment once weekly.
15728674|NCT05034861|Diagnostic Test|Doppler|Standard Doppler assessment provided once weekly in case of late FGR with positive end diastolic flow in the umbilical artery.
15728675|NCT05034848|Procedure|Assessment of BMD by DXA and HRpQCT|"DXA : BMD assessment at the left hip, rachis and both legs
~HRpQCT : Volumic Bone mineral density, cortical and trabecular parameters, at the non dominant radius and legs
~Biological samples"
15728679|NCT05034809|Drug|Melatonin 20 MG|Melatonin, also known as N-acetyl-5-methoxytryptamine will be the main intervention given to participating patients of this study. This study will use a dose of 20mg/day using the commercially available 5mg/tablet20-21. If a patient cannot be tolerate swallowing the whole tablet, it will be crushed and mixed with milk. According to the study done by Shah et al. there was no degradation in the active component of melatonin when mixed with milk or food as a medium for drug delivery.
15728680|NCT05034783|Drug|[68Ga]Ga-HBED-CC-exendin-4|Intravenous injection of one dosage of 74-111 MBq (2-3 mCi) [68Ga]Ga-HBED-CC-exendin-4. Tracer doses of [68Ga]Ga-HBED-CC-exendin-4 will be used to image lesions of insulinoma by PET/CT.
15728681|NCT05034783|Drug|[68Ga]Ga-NOTA-exendin-4|Intravenous injection of one dosage of 74-111 MBq (2-3 mCi) [68Ga]Ga-NOTA-exendin-4. Tracer doses of [68Ga]Ga-NOTA-exendin-4 will be used to image lesions of insulinoma by PET/CT.
15728682|NCT05034770|Other|major ozone autohemotherapy|This treatment is based on treating 100 ml of the pa- tient's blood with 100 ml of O3 followed by reinfusion in the donor, in a fast procedure. Each patient received 10 sessions of autohemotherapy with O3 twice a week.
15728683|NCT05034757|Other|HA only|HA injection only
15728684|NCT05034757|Other|ESWT once|ESWT of the shoulder the patient will receives STORZ Extracorporeal Shock Wave Therapy 3000 impulses (each point) of shockwaves at 24kV (energy flux density, 0.32mJ/mm2) to the affected shoulder
15728685|NCT05034757|Other|ESWT twice|ESWT of the shoulder the patient will receives STORZ Extracorporeal Shock Wave Therapy 3000 impulses (each point) of shockwaves at 24kV (energy flux density, 0.32mJ/mm2) to the affected shoulder
15728686|NCT05034718|Other|PIBIS clinical decision support|The intervention is the presence of the PIBIS physician alert and powerform, which is clinical decision support for the treating provider if a patient meets inclusion criteria for Pittsburgh Infant Brain Injury Score (PIBIS) calculation.
15728687|NCT05034718|Other|Standard of care|Standard of care, absent the PIBIS powerform and alert for providers.
15728688|NCT05034705|Device|Conventional suction system|This is the conventional method of using the dental high volume suction to contain the aerosol generated during dental procedure. The saliva ejector will also be used.
15728689|NCT05034705|Device|Dental aerosol box with modified high volume evacuation system|The dental aerosol box will be equipped with an exit for the high volume suction to be attached to contain the aerosol generated during dental procedure. The saliva ejector will also be used.
15728690|NCT05034692|Procedure|Total laparoscopic with intracorporeal anastomosis by overlap method|After the intestinal canal was dissociated and vascularized, the intestinal canal was nuded and cut off, and the distal and proximal intestinal canals were overlapped by 6 cm
15728729|NCT05034380|Behavioral|Acute exercise|All participants consumed a standardized, high carbohydrate meal (7 kcal/kg; 60% carbohydrate, 25% fat, 15% protein) and completed an exercise testing trial, expending a total of 650 kcal upon completion 4h later.
15728730|NCT05034367|Diagnostic Test|Mannitol challenge|Inhalation challenge with dry powder of mannitol with a maximal cumulative dose of 635 mg
15728691|NCT05034692|Procedure|Laparoscopic-assisted colectomy with extracorporeal anastomosis|After the corresponding colon and blood vessels were dissociated and treated, the carbon dioxide pneumoperitoneum was removed. The appropriate length of the incision was cut at the corresponding position of the abdomen, and the incision protector was placed. The tumor was lifted together with the free intestinal canal to the outside of the abdomen. The intestinal canals at the quasi-dismembered sites on both sides of the tumor were nuded, and the colon-colon functional end-to-end anastomosis was performed.
15728692|NCT05034679|Biological|Vcinated|Patients who were vacinated.
15728693|NCT05034666|Behavioral|Before the education program|Before applying the education program of the endotracheal cuff pressure inflation to the participating anaesthetists.
15728694|NCT05034666|Behavioral|After the education program|After applying the education program of the endotracheal cuff pressure inflation to the participating anaesthetists.
15728695|NCT05034653|Other|Intermittent Fasting|During fasting day, no food or drink allowed from dawn to dusk
15728696|NCT05034653|Other|Healthy Plate|Quarter-quarter-half meal concept
15728697|NCT05034640|Procedure|Conventional multiport thoracoscopic surgery|Use 2 or more incisions for multiple instrument entry during the surgery and chest tube placement at the end of the operation.
15728698|NCT05034640|Procedure|Single port site thoracoscopic surgery|Using only 1 incision for multiple instrument entry during the surgery and chest tube placement at the end of the operation. Single port - GelPOINT Mini® port (Applied Medical, Rancho Santa Margarita, California, USA)
15728699|NCT05034627|Procedure|Biopsy|Undergo biopsy
15728700|NCT05034627|Drug|Calaspargase Pegol-mknl|Given IV
15728701|NCT05034627|Drug|Cobimetinib|Given PO
15728706|NCT05034588|Diagnostic Test|Cardiac magnetic resonance scan|Multiparametric cardiac magnetic resonance, including functional and structural parameter
15728707|NCT05034575|Other|Eye Tracking Technology Sensor|Eye tracking will be performed using Tobii Pro eye tracking technology sensor (Tobii Pro Fusion, Stockholm, Sweden), providing binocular eye tracking up to 250 Hz. The sensor, positioned on the inferior aspect of the computer monitor, reflects infrared (IR) light beams off of each cornea and are subsequently captured.
15728708|NCT05034562|Procedure|Computed Tomography|Undergo PET/CT
15728709|NCT05034562|Drug|Gallium Ga 68-labeled PSMA-11|Given IV
15728710|NCT05034562|Procedure|Magnetic Resonance Imaging|Undergo PET/MRI
15728711|NCT05034562|Procedure|Positron Emission Tomography|Undergo PET/CT or PET/MRI
15728712|NCT05034549|Device|Noninvasive ventilation|The non-invasive ventilator at home (≥5h/ night)
15728713|NCT05034536|Drug|Pembrolizumab|Intravenous infusion
15728714|NCT05034536|Drug|Infliximab|Intravenous infusion
15728715|NCT05034536|Drug|Placebo|Intravenous infusion
15728716|NCT05034523|Radiation|MRI Voxel based morphometry|Voxel based morphometry through analysis of 3D T1 weighted sequence to assess total intracranial volume. All participants were scanned on the 1.5Tesla MR scanner (Achieva, Philips Medical Systems, Best, NL) with a 16-channel head coil at the diagnostic radiology department.
15728717|NCT05034510|Device|Deep Brain Stimulation|modification in stimulation parameters
15728718|NCT05034497|Drug|186RNL|"All participants will be required to have an Ommaya Reservoir and a CSF Flow Study.
~Participants will receive a single 5cc dose of 186RNL via Ommaya Reservoir."
15728719|NCT05034484|Drug|ALPN-303|Multiple dose levels will be evaluated.
15728720|NCT05034484|Drug|Placebo|Placebo matching ALPN-303 will be administered
15728721|NCT05034458|Dietary Supplement|Crohn's disease exclusion diet|Patients will receive, in addition to their normal treatment, polymeric formula + diet
15728722|NCT05034445|Diagnostic Test|Next generation sequencing|Extract DNA from sputum sample, minimum DNA amount should be over 50ng.
15728723|NCT05034432|Procedure|Intra-Op Prophylactic VT ablation|For surgical intra-operative ablation, efforts will be made to identify scarred myocardium based on methods such as cardiac magnetic resonance imaging, nuclear scans, and/or echocardiogram. Electrophysiological mapping may be obtained either pre-surgery or intra-operation. Mapping and ablation will be performed with the currently approved and updated mapping and ablation systems available at each center. Voltage mapping of the ventricle(s) to delineate scars will be carried out through electroanatomic mapping
15728724|NCT05034432|Other|Conventional Management|To ensure uniformity in control arm, a standardized AAD regimen is recommended among subjects randomized to the medical management control arm. Subjects who are already on a stable AAD regimen, such as amiodarone, sotalol or dofetilide, these should be continued
15728725|NCT05034419|Device|Parasym|Stimulation will be done under anesthesia for 30 minutes. Stimulation parameters include a pulse width of 200 μs, amplitude of 20 mA and a pulse frequency of 20 Hz. The Parasym devise (Parasym Health, London, UK) will be used for stimulation. The device will be connected to a clip electrode that will be attached to the external ear. In the active group, the ear clip electrode will be attached to tragus in the active stimulation group. This device has been deemed non-significant risk by the FDA. In the control group, no stimulation will be done.
15728726|NCT05034419|Device|Sham stimulation|Sham stimulation
15728727|NCT05034406|Drug|2% Lidocaine|6 mL of 2% lidocaine injected at the trocar insertion site.
15728728|NCT05034406|Drug|0.5% levobupivacaine|6 mL of 0.5% levobupivacaine injected at the trocar insertion site.
15728751|NCT05034146|Device|PET/CT|68Ga-FAPI PET/CT scan were performed 20~60 min after 68Ga-FAPI (1.85-3.7MBq/kg) injection intravenously.
15728731|NCT05034354|Device|Remote physiological monitoring|Participants will be provided with a Bluetooth capable weight scale (A&D Medical UC-352BLE or Beurer BY90), oxygen saturation monitor (Contec Medical Systems CMS50D-BT) and automatic blood pressure monitor (A&D Medical UA- 651BLE) to use daily for at least 10 days of a 14-day trial period. Data will be sent via the Sphygmo App to the pediatric cardiology for monitoring. Parents and healthcare providers will be asked to participate in a qualitative interview and the end of the 14-day period to provide feedback on the devices and Sphygmo™ platform.
15728732|NCT05034341|Other|Multimodal Prehabilitation|"In addition to Standard Clinical Care
~Behavioral - An exercise program focusing on aerobic exercise as well as strength training. Sessions will be supervised by a physical therapist, 2 times a week for a minimum of 6-8 weeks in addition to home exercise program. They will also participate in a single session of Cognitive-Behavioral Therapy and will receive an educational pamphlet about Pain and Neuroscience Education.
~Dietary Supplement - Protein supplements in the form of protein shakes at a dose of 1.2-1.5 gram per kg daily for 6-8 weeks. Protein supplements will be calculated based on ideal body weight and will be given to the patient with instructions on specific use. Diabetic patients will receive protein supplements that are sugar free."
15728733|NCT05034341|Other|Standard Pre-Surgical Clinical Care|"Education related to preoperative activity and home-based exercise program.
~Standard preoperative consultation with anesthesiology: Preoperative medical optimization and management, referral to medical specialties as deemed necessary with focus on preoperative cognitive assessment."
15728734|NCT05034328|Device|Healsea® Children|Children will be administered Healsea Children , one puff (1-2 sec) in each nostril twice a day for 10 days on top of conventional therapies, as needed
15728735|NCT05034328|Other|Conventional therapies for common cold|Children will receive conventional therapies for common cold, nasal irrigation excluded (antipyretics, mucolytics, decongestants, antitussives, systemic and topical corticosteroids, antibiotics)
15728736|NCT05034315|Other|Whole egg consumption|The participants in the whole egg group consumed two whole eggs immediately after exercise.
15728737|NCT05034276|Other|MORE-VR|Mindfulness-Oriented Recovery Enhancement therapy delivered over virtual reality.
15728738|NCT05034250|Diagnostic Test|Blood sample|Blood samples were taken from a peripheral vein as part of clinical routine. Subsequently, the iron status is determined.
15728739|NCT05034237|Device|ND;YAG 1064NM LASER|laser hair removal sessions
15728740|NCT05034224|Device|Swan-Ganz catheter placed in the coronary sinus - deflated|A normal Swan-Ganz catheter will be advanced in the coronary sinus. The Balloon will be kept deflated during sham intervention. The index of microvascular resistances will be measured using the Abbott Pressure Wire X as per instructions for use durng both interventions.
15728741|NCT05034224|Device|Swan-Ganz catheter placed in the coronary sinus - inflated|A normal Swan-Ganz catheter will be advanced in the coronary sinus. The Balloon will be inflated to obtain coronary sinus occlusion during the active intervention. The index of microvascular resistances will be measured using the Abbott Pressure Wire X as per instructions for use durng both interventions.
15728742|NCT05034211|Procedure|Programmed intermittent bolus epidural|one arm will receive programmed intermittent boluses of local anesthetic via the epidural catheter on fixed time intervals. Standard 27G Tuohy needle epidural set with epidural catheter insertion on L2-L3 site, with the patient either sitting or in the lateral decubitus position will be used. Local injection with 6 ml lidocaine 2% will be performed before the insertion of the epidural needle
15728743|NCT05034211|Procedure|Provider administered analgesia on patient request|one arm will receive bolus of local anesthetic via the catheter upon patient request. Standard 27G Tuohy needle epidural set with epidural catheter insertion on L2-L3 site, with the patient either sitting or in the lateral decubitus position will be used. Local injection with 6 ml lidocaine 2% will be performed before the insertion of the epidural needle
15728744|NCT05034198|Behavioral|Coping Power Program (CPP)|CPP is an evidence-based intervention designed for students with externalizing behavior disorder. CPP consists of twelve 45-minute sessions. This EBP has been found to be effective at reducing aggressive behavior, covert delinquent behavior and substance abuse among aggressive boys, with gains maintained at one-year follow-up. Growth curve analyses showed that CPP had linear effects for three years after intervention on reductions in aggressive behavior and academic behavior problems.
15728745|NCT05034198|Behavioral|Cognitive behavioral therapy (CBT) for Anxiety Treatment in Schools (CATS)|CATS is an adaptation of Friends for Life (FRIENDS). The adapted protocol retains the core elements of evidence-based CBT for anxiety and the FRIENDS group format. Investigators implemented planned adaptations to the protocol based on collective experience. Changes were made to the language, cultural methods, number of sessions, and activities while maintaining the 5 essential components of the treatment. This resulted in a briefer (8-session) and more feasible, engaging and culturally appropriate protocol for urban under-resourced schools than the original FRIENDS.
15728746|NCT05034198|Behavioral|Check-in/Check-out (CI/CO)|CI/CO is a targeted, Tier 2 intervention for students at risk of developing externalizing and internalizing mental health disorders. CI/CO is designed to provide immediate feedback (i.e., at the end of each class period) to students, based on the use of a daily report card. This feedback is developmentally sensitive. CI/CO implementers meet individually with students for a brief 'check-in' in the morning and a brief 'check-out' in the afternoon. Research on the use of CI/CO has shown it to be effective in reducing externalizing and internalizing problems with elementary school students. CI/CO will be offered to individual students for a three-month period of time, which is the same time-frame needed for the implementation of CPP.
15728747|NCT05034185|Device|Computer-aided diagnosis (CADx) support tool|"The CADx support tool operates when the Clinician switches the preconfigured CAD EYE function on using a button on the controller while the scope system is in BLI mode. This is performed after the Clinician first makes an optical prediction of polyp histology using IEE as described. The CADx support tool will make a prediction of polyp histology as hyperplastic or neoplastic."
15728748|NCT05034172|Other|Clinical follow-up|"Clinical Follow-up:
~demographic data and history,
~Retrospective interview (collection of data useful for genetic studies): -disease history (for patients only);
~Family history - Neurological examination:
~Diagnosis Clinical examination;
~Rating scales specific to the pathology under investigation;
~Cerebral MRI (optional)
~Biological samples (optional)"
15728750|NCT05034146|Drug|68Ga-FAPI|68Ga-FAPI was injected intravenously to each subject, and the dose is calculated according to body weight of subject (approximately 1.85-3.7MBq/kg).
15728752|NCT05034133|Drug|Durvalumab|Durvalumab (IV 1000mg on day 1) with chemotherapy (Etoposide and Cisplatin) for 6 cycles
15728753|NCT05034120|Drug|XZP-3621|Administer a single dose of XZP-3621 tablet after a low-fat meal.
15728754|NCT05034120|Drug|XZP-3621|Cycle1(D1-D9): Administer the XZP-3621 tablet on an empty stomach in a single dose on Day1; Cycle2(D10-D18): Administer the XZP-3621 tablet after a high-fat meal in a single dose on Day10; Cycle3(D19-D27): Administer the XZP-3621 tablet after a standard meal in a single dose on Day19.
15728755|NCT05034120|Drug|XZP-3621|Cycle1(D1-D9) : Administer the XZP-3621 tablet after a high-fat meal in a single dose on Day1; Cycle2(D10-D18): Administer the XZP-3621 tablet after a standard meal in a single dose on Day10; Cycle3(D19-D27): Administer the XZP-3621 tablet after on an empty stomach in a single dose on Day19.
15728756|NCT05034120|Drug|XZP-3621|Cycle1(D1-D9): Administer the XZP-3621 tablet after a standard meal in a single dose on Day1; Cycle2(D10-D18): Administer the XZP-3621 tablet on an empty stomach in a single dose on Day10; Cycle3(D19-D27): Administer the XZP-3621 tablet after a high-fat meal in a single dose on Day19.
15728757|NCT05034120|Drug|XZP-3621|Cycle1(D1-D9) : Administer the XZP-3621 tablet on an empty stomach in a single dose on Day1; Cycle2(D10-D18): Administer the XZP-3621 tablet after a standard meal in a single dose on Day10; Cycle3(D19-D27): Administer the XZP-3621 tablet after a high-fat meal in a single dose on Day19.
15728758|NCT05034120|Drug|XZP-3621|Cycle1(D1-D9): Administer the XZP-3621 tablet after a high-fat meal in a single dose on Day1; Cycle2(D10-D18): Administer the XZP-3621 tablet on an empty stomach in a single dose on Day10; Cycle3(D19-D27): Administer the XZP-3621 tablet after a standard meal in a single dose on Day19.
15728759|NCT05034120|Drug|XZP-3621|Cycle1(D1-D9): Administer the XZP-3621 tablet after a standard meal in a single dose on Day1; Cycle2(D10-D18): Administer the XZP-3621 tablet after a high-fat meal in a single dose on Day10; Cycle3(D19-D27): Administer the XZP-3621 tablet on an empty stomach in a single dose on Day19.
15728760|NCT05034107|Other|Aromatherapy|Approximately 6-7 drops of Ylang-ylang essential oil will be diffused in a common area estimated to be about 300 square feet with temperature of around 25 - 26 degree Celsius and humidity of 50% - 60%. Water and essential oil will be diffused twice a day, each for a duration of 20 min during the respective phases.
15728761|NCT05034094|Other|VEMP recording|"Clinical evaluation: All participants will undergo detailed medical and neurological histories and examinations.
~The severity of manifestations of PD will be assessed using the Movement Disorder Society (MDS)-sponsored new version of Unified PD Rating Scale (MDS-UPDRS)."
15728762|NCT05034081|Procedure|body contouring|any post-bariatric body contouring surgery included
15728763|NCT05034068|Drug|0.15% bezaydamine hydrochloride.|0.15% bezaydamine hydrochloride was applied in oral mucosa in Patients with head and neck cancer under RT, CT treatment.
15728764|NCT05034068|Device|low power laser with a wavelength of 870 nm|the irradiations will be done three times a week using low power laser with a wavelength of 870 nm. The irradiation mode will be punctual and in contact, perpendicular to the oral mucosa. The power will be 60 mW, energy density of 6 J/cm2. Irradiation time will be 6 seconds per point based on the laser beam spot size of 0.55cm2
15728765|NCT05034055|Drug|atezolizumab / tiragolumab|All patients will receive 1200mg atezolizumab administered by IV infusion on Day 1 of each 21-day cycle after completion of stereotactic body radiotherapy (SBRT) for 21(+5) days. No escalations or reductions in the dose of the investigational product will be allowed.Following the administration of atezolizumab, patients will receive 600mg tiragolumab administered by IV infusion on Day 1 of each 21-day cycle. The tiragolumab dose is fixed and is not dependent on body weight.
15728768|NCT05034029|Drug|Metformin hydrochloride sustained release tablets|Oral
15728769|NCT05034029|Drug|Placebo|Placebo
15728770|NCT05034016|Device|High Myopic Posterior Scleral Fixation System|Implant HM into the eye through posterior scleral reinforcement
15728771|NCT05034003|Device|Zirconia crown|Esthetic crowns for capping primary incisor with caries
15728772|NCT05034003|Device|composite strip crown|Esthetic resin restoration for primary incisor with caries
15728773|NCT05033977|Other|Exercise (center-based)|Exercise therapy with a physical therapist in a clinic.
15728774|NCT05033977|Other|Exercise (home-based)|Patients did exercises at home every day and 3 times per day.
15728775|NCT05033964|Combination Product|Percutaneous Coronary Intervention with drug eluting stents containing sirolimus (7mcg per mm of device length), argatroban and rivaroxaban at dosages of 8 mcg per mm of device length.|Coronary drug eluting stent implantation
15728776|NCT05033951|Other|Standard care|Both groups: standard care+ questionnaires
15728777|NCT05033938|Procedure|Early Mobilization Protocol|Subjects will be placed in a bulky soft dressing immediately after surgery. They will be made non-weight bearing, but active and passive motion of digits, forearm, elbow, and shoulder will be allowed with light functional tasks permitted as tolerated. Wrist motion within the soft dressing will be permitted as tolerated by patient. On postoperative day 3, patients will be advised to remove the dressing at home and begin home hand/wrist therapy. They will use a removable Velcro wrist splint for nighttime wear and strenuous activity. This splint can be removed during normal activities of daily living and therapy.
15728778|NCT05033938|Procedure|Late Mobilization Protocol|Subjects will be placed in a plaster volar resting splint. They will be made non-weight bearing, with use of digits for light functional tasks permitted. They will be given home exercises for their fingers but will not yet resume wrist motion
15728779|NCT05033925|Dietary Supplement|FADA (active fraction of Ficus septica leaf) 800 mg/day|FADA is given twice a day (total dose of 800 per day per patient)
15728780|NCT05033925|Dietary Supplement|FADA (active fraction of Ficus septica leaf) 2000 mg/day|FADA is given twice a day (total dose of 2000 per day per patient)
15728781|NCT05033925|Other|Placebo capsule|Placebo capsule is given twice a day
15728783|NCT05033899|Other|ERAS protocol|to compare between Enhanced Recovery After Surgery (ERAS) protocol and conventional care in non-insulin dependent diabetic patients undergoing lumbar spine surgery.
15728871|NCT05033145|Drug|AZVUDINE|AZVUDINE 5 tablets QD + standard treatment, for up to 14 days
15728786|NCT05033873|Other|Universal Exercise Unit Therapy (UEU)|Standing, walk standing, half standing, kneel standing, half kneel standing, quadruped position, three point quadruped , alternative quadruped , transitions, walking all these will be done in Universal Exercise Unit with a standardized protocol regimen.
15728787|NCT05033873|Other|Sling Exercise Therapt (SET)|"The patient's bilateral knee joints/feet will be suspended by a rope belt, and then the patient's pelvis will be elevated and maintained in supine or lateral position, adding flexion and extension training to lower limb if permitted.
~In supine or lateral position, with patient's head, trunk and pelvis fixed, the therapist will use appropriate elastic bands to assist patient's limbs to do passive-power assisted-power resistance training in all directions (bending, stretch, outreach, and adduction).
~The patient's chest and abdomen will be suspended by a wide elastic band, positioned him-self in the prone position with the fulcrum of bilateral elbows and knees, and then the torso swayed in all directions, therapists could assist
~Target elbow and wrist will be suspended, according to the patient's ability to do passive/active open and close chain movement"
15728788|NCT05033873|Other|Routine Physical Therapy / Control Group|"Control group will receive routine physiotherapy with duration one hour including
~Active and passive joint movement
~Muscle strength training
~Bridging exercises
~Balance training in sitting and standing positions, according to the patients' functional state.
~Weight bearing exercises on affected Limbs"
15728789|NCT05033860|Other|Read leaflets containing knowledge of COVID-19 and vaccination.|Leaflets containing knowledge of COVID-19 and vaccination were distributed, and participants are asked to read the leaflets.
15728790|NCT05033847|Biological|Recombinant COVID-19 Vaccine (CHO cell)|Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell) in the deltoid muscle of the upper arm
15728791|NCT05033847|Biological|COVID-19 vaccine (Vero cells)|Intramuscular injection of Recombinant COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm
15728792|NCT05033834|Other|covid-19 vaccines registered in Egypt|Astra Zeneka vaccine, Sinopharm vaccine, Sinovac vaccine, Jonson and Jonson vaccine, Spotnic V vaccine
15728793|NCT05033821|Behavioral|Adapted FOY+ImPACT|The Adapted FOY+IMPACT is a selective, group-level intervention designed to prevent sexual risk-taking and substance use among adolescents affected by parental drug use. There are eight sessions for youth (FOY) and one session with youth and adults (ImPACT).
15728794|NCT05033808|Drug|Epirubicin|Epirubicin is given once over 15 Minutes via a central line
15728795|NCT05033808|Drug|Placebo|NaCl is given once over 15 Minutes via a central line
15728796|NCT05033795|Dietary Supplement|Water A|2 L of water A per day
15728797|NCT05033795|Dietary Supplement|Water B|2 L of water B per day
15728798|NCT05033782|Other|questionnaire|"Each included patient will be given a paper questionnaire, with the following questions:
~Zip code of patient's iterative residences since 2018, as well as the zip code of residence at the time of the 2 confinements
~Occupational status
~Occurrence of COVID infection/date needed for hospitalization
~During the COVID-19 outbreak, did the patient: avoid seeing a doctor, avoid going to health care facilities, stop background treatment for MS. If yes to any of the questions, the reason, date and duration of the cessation will be asked.
~Other sources of data will be used together:
~Clinical data from the OFSEP registry Pollution data from approved air quality monitoring associations Data on the circulation of influenza and gastroenteritis, produced by Santé Publique France"
15728799|NCT05033769|Drug|Eribulin Injection [Halaven]|on days 1 and 8 q21d
15728800|NCT05033769|Drug|Paclitaxel injection|on days 1, 8, and 15 q21d
15728801|NCT05033756|Drug|Pembrolizumab Injection [Keytruda]|The planned dose of pembrolizumab for this study is 200 mg every 3 weeks (Q3W). Based on the totality of data generated in the Keytruda development program, 200 mg Q3W is the appropriate dose of pembrolizumab for adults across all indications and regardless of tumor type.
15728802|NCT05033756|Drug|Olaparib Oral Tablet [Lynparza]|All patients will receive olaparib treatment as an addition to pembrolizumab. The dose of olaparib used in this study is 300 mg twice daily (total daily dose of 600 mg) which is the currently approved dose.
15728803|NCT05033743|Drug|Secnidazole 2 GM Oral Granules|Once weekly 2g oral secnidazole for 18 weeks
15728804|NCT05033730|Device|Flow Controlled Ventilation|Mechanically ventilated using Flow Controlled Ventilation (FCV)
15728805|NCT05033717|Other|Tissue Flossing Technique|"Subjects will receive tissue-flossing intervention on bicep muscle for 30 sec to 2 min with an occlusion pressure of 100 mmHg.
~After removal of flossing, participants will perform bicep strengthening exercises at an intensity of 30% of 1 RM with 6-8 rep, 4 sets for a single day and 3 days per week for 2 weeks in total."
15728806|NCT05033717|Other|Static Stretching Technique|"Subjects will perform passive static stretching exercises of bicep muscle. Each stretch will last for 30 sec at 100% of stretch intensity with 4 reps for each, 1 set per day and 3 days per week for total duration of two weeks.
~After the application of static stretch, participants will perform bicep strengthening exercises at an intensity of 30% of 1 RM with 6-8 reps, 4 sets for a single day and 3 days per week for 2 weeks in total."
15728807|NCT05033704|Drug|5% human plasma protein fraction (PPF)|"Infusion of 5% human plasma protein fraction PPF. PPF 5% Octapharma 5 % is a colloid solution containing (47.6-52.5% proteins, of which 45.6-52.5 gm/L albumin and 142.5-157.5 mmol/L sodium)."
15728808|NCT05033691|Radiation|Stereotactic surgery|At two month (8 weeks) post Osimertinib start, patients will be randomized into one of the two study arms. Arm A patients will be treated with stereotactic surgery (SRS). In both arms Osimertinib treatment will continue.
15728809|NCT05033678|Device|Diagnostic algorithms|Assessors of teledermoscopy will be asked to review the results of artificial intelligence displayed differently and at different time points in their assessment.
15728810|NCT05033665|Behavioral|Increase water consumption|The underhydrated individuals will be instructed to increase their water intake for one week in order to meet the following two criteria: a) urinate at least 7 times per day and b) have straw-like color urine. A 2-mile run will be completed before and after the 7-day intervention.
15728811|NCT05033665|Behavioral|Maintain adequate water consumption|The subjects that are classified as euhydrated will be asked to maintain high water intake for one week to ensure proper hydration. A 2-mile run will be completed before and after the 7-day intervention.
15728869|NCT05033171|Diagnostic Test|EOS 2D/3D scanning|EOS Micro Dose imaging will be done on the third day after surgery, on the third, the sixth, the twelfth and twenty fourth month after surgery.
15728870|NCT05033158|Other|Blood sampling|Blood sampling before and after COVID-19 vaccination
15728812|NCT05033652|Other|WARNING KD|"Within 48h of detecting an abnormal creatinemia value (GFR<30 or AKIN2 and AKIN3), the biology laboratory will communicate the patient's information to the WARNING KD team. This team consists of one nephrologist and one clinical pharmacist who will trigger the initial management in the department and then, if the patient has a persistant warning signal during hospitalization, define the patient's course of treatment for discharge. Patients requiring special care will be oriented towards a nephrologist and the patient's GP will be alerted to the benefit of addressing the patient to a nephrologist for multidisciplinary management with a therapeutic project according to the recommendations for good therapeutic practices."
15728817|NCT05033613|Other|heart rate、arrhythmia、blood pressure、central body temperature (ear temperature) and blood oxygen saturation level.|heart rate、arrhythmia、blood pressure、central body temperature (ear temperature) and blood oxygen saturation level.
15728819|NCT05033587|Drug|Anlotinib|Anlotinib a multi-target receptor tyrosine kinase inhibitor.
15728820|NCT05033587|Drug|AK105|AK105 is a humanized monoclonal antibody that specifically binds to PD-1.
15728821|NCT05033587|Radiation|Radiotherapy|The radiotherapy regimen delivered 2.0Gy once a day, five days a week to a total dose of 60Gy.
15728822|NCT05033574|Diagnostic Test|Biochemical study of hormone levels|Biochemical study of the level of follicle-stimulating hormone, luteinizing hormone, estradiol, total testosterone, prolactin, 17-hydroxyprogesterone, dehydroepiandrosterone sulfate, cortisol, insulin, thyroid-stimulating hormone, tetraiodothyronine, thyr
15728823|NCT05033574|Diagnostic Test|Ultrasound examination|Ultrasound examination of the pelvic organs in girls and the scrotum organs in boys
15728824|NCT05033574|Radiation|Radiography of the hands|Determination of bone age using radiography of the hands
15728825|NCT05033574|Behavioral|Consultation of a medical psychologist|Consultation with a medical psychologist to determine the patient's psychological condition and level of intelligence
15728826|NCT05033561|Biological|nOPV2|Novel Oral Poliomyelitis Type 2 Vaccine
15728827|NCT05033535|Drug|Sacubatril Allisartan medoxomil|Sacubatril Allisartan medoxomil ：A randomized, double-blind, placebo and positive drug parallel controlled, multi-center phase II clinical study on the effectiveness and safety of treating mild and moderate essential hypertension
15728828|NCT05033535|Drug|Olmesartan Medoxomil|Efficacy for lowering blood pressure of Olmesartan medoxomil
15728829|NCT05033522|Biological|AlloStim® immunotherapy|3 cycles of intradermal and intravenous administrations
15728830|NCT05033522|Drug|FOLFOX regimen|Comparative arm: Physician Choice of palliative chemotherapy+best supportive care or best supportive care alone
15728831|NCT05033522|Other|Best Supportive Care|Comparative arm: Physician Choice of palliative chemotherapy+best supportive care or best supportive care alone
15728832|NCT05033509|Other|supervision the Kidney fonction on ECMO|patients who benefited from ECMO, and presented an acute kidney injury afterwards
15728833|NCT05033496|Diagnostic Test|Thyroid function test|Thyroid function test
15728834|NCT05033483|Dietary Supplement|Ferrous Fumarate|Gelatin capsule containing 200 mg ferrous fumarate and microcrystalline cellulose
15728835|NCT05033483|Dietary Supplement|Placebo|Gelatin capsule containing microcrystalline cellulose
15728836|NCT05033470|Device|Dabir Mattress Overlay System|Dabir Surface mattress overlay system consists of a controller and a low-profile alternating pressure (AP) surface (placed over a non-powered mattress) with hundreds of air-filled geometric nodes arranged in rows. . The multiple rows of nodes inflate and deflate in alternating sequence every five minutes. During deflation phase, the skin and soft tissues experience reduced pressure/loading and enhanced perfusion. In conjunction with Standard of Care: Debridement, Proper moisture balance, off-loading, reduce bacterial burden and nutritional counseling.
15728837|NCT05033457|Procedure|unilateral biportal endoscopy technique or percutaneous endoscopic transforaminal discectomy|Treatment of lumbar intervertebral disc herniation with unilateral biportal endoscopy technique in unilateral biportal endoscopy technique group.Treatment of lumbar intervertebral disc herniation with percutaneous endoscopic transforaminal discectomy in percutaneous endoscopic transforaminal discectomy group.
15728838|NCT05033444|Drug|PRV-002|Eligible participants will be randomised to receive a single ascending dose of PRV-002 on study Day 1. Dose escalation will be conducted in a total of 3 cohorts. Within each cohort, 6 participants will be randomised to receive a single dose of PRV-002. The starting dose, dose increments and dose range to be evaluated are based on available nonclinical data. PRV-002 dose levels in the range of 0.161 to 0.645 mg/kg will be investigated.
15728839|NCT05033444|Drug|Placebo|Placebo used is hydroxypropyl beta cyclodextrin (HPβCD)
15728841|NCT05033418|Behavioral|Cognitive Behavioral Therapy for Insomnia (CBT-I)|4-session CBT-I group in addition to IPRP
15728842|NCT05033418|Behavioral|Interdisciplinary Pain Rehabilitation Program (IPRP)|10-week IPRP usual care
15730125|NCT05023538|Other|Cycling|Exercise on bicycle ergometer
15728843|NCT05033405|Behavioral|NEURO-LINGUISTIC PROGRAMMING (NLP)|● One session (20-minute long) of NLP application was performed. The NLP techniques that were employed were representational systems and submodality. In this technique, the sensory, auditory, and kinesthetic feelings of the individual are learned. These emotions are modified by imagining. The NLP application was carried out by a researcher who has a certificate in this field
15728844|NCT05033392|Drug|Toripalimab Injection|A domestic PD-1 antibody
15728845|NCT05033379|Behavioral|Control|Importance of sleep
15728846|NCT05033379|Behavioral|Resilience coaching|Arena Strive
15728847|NCT05033366|Diagnostic Test|Proov Test|Rapid response urine PdG and LH test strips, Proov
15728848|NCT05033353|Diagnostic Test|Monitoring of regional cerebral oxygenation|Regional cerebral oxygenation was monitored using near-infrared spectroscopy (O3TM, Masimo, Irvine, CA) placed on the patient's forehead.
15728849|NCT05033340|Drug|Etrasimod|Study drug will be provided in induction-sealed, high-density polyethylene bottles with child-resistant screw caps.
15728850|NCT05033340|Drug|Placebo|Study placebo will be provided in induction-sealed, high-density polyethylene bottles with child-resistant screw caps.
15728851|NCT05033327|Behavioral|Nutrition and Exercise app|Personalized, home-based, interactive therapy app
15728852|NCT05033314|Drug|Rivaroxaban 10 MG|Rivaroxaban 10mg PO daily as thromboprophylaxis
15728853|NCT05033314|Drug|Placebo|matching placebo daily
15728854|NCT05033301|Device|Nurse Ned Clinic|Participants enrolled in the Nurse-led Ned Clinic will receive virtual PCa survivorship follow-up care from both their specialist and an oncology nurse for one year.
15728855|NCT05033288|Other|Electronic Health Record Review|Medical records are reviewed
15728856|NCT05033288|Other|Quality-of-Life Assessment|Complete quality of life questionnaires
15728857|NCT05033262|Other|Our Memory Care Wishes|Our Memory Care Wishes is a web-based advance care planning platform designed for persons living with dementia in nursing homes to discuss and document healthcare and daily life preferences with the help of shared decision-makers. Penn researchers meet via Zoom with PLWD and their SDMS and nursing home staff to facilitate website completion.
15728858|NCT05033249|Diagnostic Test|Immature granulocyte count|Automatically calculated immature granulocyte count in white blood cell count
15728859|NCT05033249|Diagnostic Test|Immature granulocyte percentage|Automatically calculated immature granulocyte percentage in white blood cell count
15728860|NCT05033223|Other|PTSD evaluation of emergency room staff 9 and 12 months after the end of second lockdown in France during COvid-19 pandemic|PCL-5 autoquestionnaire to make the PTSD diagnosis
15728861|NCT05033210|Behavioral|Psychological First Aid (PFA)|PFA is a WHO developed support strategy that involves humane, supportive and practical help for individuals living in a serious humanitarian crisis. PFA does not necessarily involve a discussion of the event(s) that cause the distress but aims particularly at five basic elements that are crucial to promote in the aftermath of crises, i.e. a sense of safety, calm, self- and community efficacy, connectedness, and hope (Hobfoll et al., 2007). It consists of a conversation (approximately 30-45 minutes) that a helper has with a participant which can be provided remotely (e.g. videoconferencing or telephone). It has various themes; the helper provides non-intruding practical care and support, listen to needs and concerns, helps people to address basic needs (e.g. information), listens to people without pressuring them to talk, comforts people and helps them to feel calm, helps people to connect to information, services, and social support, and protects people from further harm (WHO, 2011).
15728862|NCT05033210|Behavioral|Care as Usual (CAU)|In addition to PFA, both arms will be allowed to receive any usual care (CAU). CAU ranges from community care to specialised psychological treatments.
15728863|NCT05033210|Behavioral|Doing What Matters in Times of Stress (DWM)|DWM is based on the acceptance and commitment therapy (ACT), a form of cognitive-behavioural therapy, with distinct features (Hayes, Levin, Plumb-Vilardaga, Villatte & Pistorello, 2013). ACT is based on the concept that ongoing attempts to suppress unwanted thoughts and feelings can make these problems worse, so instead it emphasises on learning new ways to accommodate these thoughts and feelings without letting them dominate. ACT has been shown to be useful for a range of mental health issues (Tjak et al., 2015) and has been used successfully in a guided self-help format (Hayes et al., 2013). DWM includes five sections (or modules), each of which focuses on a specific skill. In this study, the DWM program will be delivered as an online intervention. The DWM intervention, i.e. both the audios and the self-help guide, will be adapted for use on a smartphone or other device with internet access.
15728864|NCT05033210|Behavioral|Problem Management Plus (PM+)|PM+ is a brief, psychological intervention program based on cognitive behavioural therapy (CBT) techniques that are empirically supported and formally recommended by the WHO (Dua et al., 2011). The manual involves the following empirically supported elements: problem solving plus stress management, behavioural activation, facing fears, and accessing social support. In these 90-minute sessions participants may talk to trained non-professional helpers (who are supervised by registered (clinical) psychologists). PM+ has four core features: it is brief (five sessions); delivered by non-specialist helpers; transdiagnostic thereby addressing depression, anxiety, PTSD, stress and problems as defined by people themselves; and originally designed for people in low-income country communities but easily adaptable to different (vulnerable) populations, cultures and languages.
15728865|NCT05033197|Behavioral|CBBS intervention|The CBBS intervention group received the 16-week intervention, including 16 CBBS lessons in basketball unit (two 40-minute lessons/week, 8 weeks) and 16 CBBS lessons in soccer unit (two 40-minute lessons/week, 8 weeks) during the 2018-2019 school year.
15728868|NCT05033171|Diagnostic Test|3D Scanning|3D scanning of the rod using Artec Eva Spider type manual 3D scanner
15728872|NCT05033145|Drug|AZVUDINE placebo|5 tablets QD + standard treatment, for up to 14 days
15728875|NCT05033106|Drug|Bevacizumab, Ranibizumab|• A dose of 0.25 mg/0.025 mL ranibizumab (Lucentis) is injected in the right eye of the infant and 0.625 mg/0.025 mL bevacizumab is injected into the vitreous cavity of the left eye 1 mm posterior to the superior/inferior temporal limbus via 30 G needle. The two injections are done sequentially on two consecutive days starting with the eye of more advanced disease.
15728876|NCT05033093|Drug|Root Canal Sealants|it is planned to conduct the research described below, on the effect of calcium silicate-based (iRoot SP), silicone-based (GuttaFlow Bioseal) and rezin-based (AH Plus) sealer on postoperative pain
15728877|NCT05033080|Drug|VX-121/TEZ/D-IVA|Fixed-dose combination tablets for oral administration.
15728878|NCT05033080|Drug|ELX/TEZ/IVA|Fixed-dose combination tablets for oral administration.
15728879|NCT05033080|Drug|IVA|Tablet for oral administration.
15728880|NCT05033080|Drug|Placebo (matched to VX-121/TEZ/D-IVA)|Placebo matched to VX-121/TEZ/D-IVA for oral administration.
15728881|NCT05033080|Drug|Placebo (matched to ELX/TEZ/IVA)|Placebo matched to ELX/TEZ/IVA for oral administration.
15728882|NCT05033080|Drug|Placebo (matched to IVA)|Placebo matched to IVA for oral administration.
15728883|NCT05033067|Behavioral|P3BC|The decisional aid will be developed to enhance patients' communication about cystectomy and urinary diversions with the clinicians, patients' decisions and preparation for self-care. Program users will be able to choose from a menu to view and print: a) summaries of their responses to inquiry questionnaire about information needed, b) selected statistics about specific side effects and self-care, and c) streamed video vignettes with patient actors of mixed cancer stages, age, sex, and race talking with a clinician about their treatment outcomes and self-care. An automatically printed 2-page output to facilitate discussion will list: 1) decision role preference; 2) the 4 highest ranked information preference sheets; and 3) a summary of personal factors plus suggested discussion topics to address with the clinician. The 2-pages will be provided to the treating physician by the research coordinator before the patient's next consultation appointment.
15728890|NCT05033028|Other|Smartphone app|SOAR (Smartphones for Opioid Addiction Recovery) system (battery + platform) as a tool for adjusting MOUD dosages to reduce treatment dropout.
15728891|NCT05033015|Procedure|Mouth rinse|To test a novel mouth rinse containing enzymes to prevent development of WSL with a control
15728892|NCT05033002|Behavioral|Labda Siku Moja stigma reduction intervention|The Labda Siku Moja stigma reduction intervention is a tailored stigma reduction intervention for women living with HIV in Tanzania. It is comprised of five ethnodramas (video stories) culturally and linguistically relevant to the Tanzanian women living with HIV.
15728893|NCT05032989|Procedure|Extraction of mandibular 3rd molar via Cowhorn forcep technique|Cowhorn forceps technique used to extract the tooth results in less post operative pain and swelling also it makes the extraction easier.
15728894|NCT05032989|Procedure|Extraction of mandibular 3rd molar via conventional technique|Conventional method of extraction uses dental elevator and forceps resulting in post operative pain and swellig.
15728895|NCT05032976|Biological|Comirnaty|"According to the approved labeling, the recommended dose of COMIRNATY is a series of two doses (1 day 1 dose, 0.3mL each) 21 days apart and administered IM.
~Individuals may not be protected until at least 7 days after their second dose of the vaccine.
~Refer to the latest local product document (LPD) for details on prescription."
15728896|NCT05032963|Behavioral|Overnight polysomnography examinations|sleep lab for overnight polysomnography examinations
15728900|NCT05032937|Drug|domestic polysaccharide superparamagnetic iron oxide nanoparticle|Patients will receive contrast-enhanced cardiac magnetic resonance with polysaccharide superparamagnetic iron oxide nanoparticle before percutaneous coronary angiography.Patients received intravenous polysaccharide superparamagnetic iron oxide nanoparticle before magnetic resonance imaging.
15728901|NCT05032924|Combination Product|PPR group with ESWT|extracorporeal shock wave (ESWT) (STORZ MEDICAL Extracorporeal Shock Wave Therapy) (3000 impulse, each point, 24 KV, 0.32 mJ/mm2) one week after PRP or HA injection
15728902|NCT05032924|Combination Product|PPR group without ESWT|PRP or HA injection only
15728903|NCT05032924|Combination Product|HA group with ESWT|extracorporeal shock wave (ESWT) (STORZ MEDICAL Extracorporeal Shock Wave Therapy)
15728904|NCT05032924|Combination Product|HA group without ESWT|PRP or HA injection only
15728905|NCT05032911|Diagnostic Test|sensorimotor control analysis using inertial sensor technology|Inertial Measurement Unit (IMU) sensors will measure sensorimotor control variables including active range of motion, movement speed, acceleration, smoothness of motion, head repositioning accuracy and motion coupling patterns
15728939|NCT05032651|Device|novel artificial intelligence assisted platform|Use of a novel artificial intelligence assisted platform
15729102|NCT05031546|Drug|Difelikefalin|IV Difelikefalin 0.5 mcg/kg administered after each dialysis session (3 times/week)
15728906|NCT05032885|Other|physiotherapy|"Patients in the intervention group will receive early physiotherapy treatment. This intervention will consist of exercises and physiotherapy techniques commonly used and aimed at improving the patient's respiratory and motor conditioning.
~At the respiratory level: diaphragmatic and costal targeted ventilation, pursed-lip breathing and bronchial hygiene techniques if required.
~At the motor level: passive, active-assisted kinesitherapy and analytical and global potentiation of the upper and lower limbs that will allow the maintenance and improvement of the articular pathway and will prevent muscle weakness; retraining of transfers and balance; gait reeducation."
15728907|NCT05032872|Behavioral|Social Exergame Treatment Group|"Physical activity tracking, walk to grow flowers and plant their own garden
~Follow workout tutorials
~Daily steps tracked by Fitbit and workout log tracked by the app
~Daily reminders to wear Fitbit, use the app, and share stories to unlock new flowers to grow
~Includes social features: like, reply, and see other's stories, and share their stories; Access to other people's gardens
~In-app rewards (unlock new flowers to grow each week) if participants post stories"
15728908|NCT05032872|Behavioral|Control Group|"Physical activity tracking, walk to grow flowers and plant their own garden
~Follow workout tutorials
~Daily steps tracked by Fitbit and workout log tracked by the app
~Daily reminders to wear Fitbit and use the app"
15728909|NCT05032859|Drug|tapinarof cream, 1%|applied topically once daily
15728910|NCT05032859|Drug|vehicle cream|applied topically once daily
15728911|NCT05032846|Procedure|Ultrasound guided laparoscopic ovarian cystectomy|Laparoscopic ovarian cystectomy to be performed under intra-operative ultrasound guidance.
15728912|NCT05032846|Other|Laparoscopic Ovarian Cystectomy|Laparoscopic Ovarian Cystectomy will be performed as standard clinical practice.
15728913|NCT05032833|Drug|5-MeO-DMT|A single dose of 5-MeO-DMT will be administered intranasally
15728914|NCT05032833|Other|Placebo|A single dose of placebo will be administered intranasally
15728916|NCT05032807|Drug|Cannabidiol standard formulation|Cannabidiol 1000mg standard formulation, single dose, oral
15728917|NCT05032807|Drug|Cannabidiol novel formulation|Cannabidiol 1000mg with lipid encapsulation, single dose, oral
15728921|NCT05032781|Drug|Intra-arterial cold saline, minocycline, and magnesium|See study design
15728922|NCT05032768|Radiation|post-operative radiotherapy|Breast cancer patients who have received reconstructive surgery will receive post-operative radiotherapy.
15728923|NCT05032755|Other|SPECTRUM NRC 102/103 investigational cigarettes|Very low nicotine content (nonmenthol/menthol) SPECTRUM investigational cigarettes
15728924|NCT05032755|Other|SPECTRUM NRC 600/601 investigational cigarettes|Normal nicotine content (nonmenthol/menthol) SPECTRUM investigational cigarettes
15728925|NCT05032742|Behavioral|mHealth parenting stress app|mHealth parenting stress app intervention to reduce parenting stress and improving youth community-based treatment engagement.
15728926|NCT05032729|Other|Trypophan, Theanine and 5'AMP|250 ml beverage consumed at 21:00 hours
15728927|NCT05032729|Other|Placebo|250 ml beverage consumed at 21:00 hours, matched in appearance and taste to the active beverages
15728928|NCT05032716|Other|Balance exrcises|the group (20 children) received traditional exercise program with instructions given to the children for 60 min aiming to improve posture control and balance. Tools of traditional physical therapy exercises were; special tools were used for traditional physical therapy exercises include vestibular board, rolls of different sizes, blocks and wedges of different heights
15728929|NCT05032716|Other|Balance exrcises and Treadmill training|the group (20 children) received the same traditional physical therapy program as the same applied in group of balance exercises, in addition to treadmill training (30 min). The child walked on the treadmill (motorized treadmill, ENTRED, Enraf-Nonius) at 75% of over-ground speed and individually prescribed low-endurance walking at 0% incline for 20 min, three times a week for 8 successive weeks. The walking area of the treadmill is made from heavy steel with a minimum 8-inch thickness and is available with cushioning in case of accidental impacts. Before the walking session, each child underwent 5 min of active stretching exercises that include prolonged and progressive stretching of the hamstrings, quadriceps muscles, and Achilles tendon.
15728935|NCT05032677|Procedure|Conventional Epidural Technique|Standard Lumbar Epidural Block using Touhy Epidural Needle (18G) at L2-3 inter-space and Epidural Catheter (20G) was inserted then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.
15728936|NCT05032677|Procedure|Dural Puncture Epidural Technique using pencil-point 25G Whitacre needle|25G Dural Puncture Epidural Block at L2-3 inter-space then bupivacaine 0.5% 15-20 ml with 50ug fentanyl was given.
15728937|NCT05032664|Other|Home-based aromatherapy programme|1 hour individualised face-to-face training to family caregivers, and 3 weeks aromatherapy intervention delivered by family caregivers (aromatherapy inhalation 2 times per day, each for 1 hour, using 2 drops of Lavandula angustifolia essential oil.
15728938|NCT05032664|Other|Control Group|Wait-list control, no intervention for 3 weeks, then provide home-based aromatherapy
15728940|NCT05032638|Behavioral|Therapist guided training|Therapist guided period delivered virtually (WebEx/Zoom). Participants will be patients associated with NYULH and will have access to Zoom. Each session will last 45 min, and will completed 3x/week by research therapists, who are part of the study.
15728941|NCT05032638|Behavioral|Upper extremity (UE) Training|The 4-week UE training is completed in the participants home on their own and communication with study staff is virtual. Participants will receive daily communication through the Expiwell app to answer survey questions related to adherence, and safety/adverse events. Participants will also complete weekly check-ins with their research therapist over Zoom to answer questions about difficulties related to UE training activities, refinement of training goals, and to receive feedback on their training performance. Each weekly check-in will be approximately 45 minutes.
15728942|NCT05032625|Procedure|Surgery|Patients who undergo surgery for NSTI will be followed in hospital and for 1- year in the office. We will asses the quality of life and there functionality. This will help us in determining the predictors of poor outcome.
15728943|NCT05032612|Device|PBM Therapy|After the endodontic treatment, PBM therapy will be performed using a 660 nm diode laser (SiroLaser Advance Plus, Dentsply Sirona Inc, Charlotte, NC, USA), with an 8mm tip diameter.The laser tip will be placed on the following external surfaces in a contact mode: mesiobuccal, distobuccal, mesiolingual and distolingual . The power output of the laser will be 50mW and will be verified by Power Meter (PM600 Power/Energy meter, Molectron Detector Inc, Portland, OR, USA). Each site will be irradiated for 25 s with an energy density of 10 J/cm2 .
15728944|NCT05032612|Device|PBM Sham|For the PBM sham similar procedure as PBM therapy will be performed without activating the laser.
15728945|NCT05032599|Biological|CD5 CART|Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: After the collection of PBMC and about 5 days before infusion, lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 250 mg/m^2/day; for prior-SCT donor-derived CAR T-cell infusion) or intensified lymphodepletion (fludarabine at 30 mg/m^2/day and cyclophosphamide at 30 mg/kg/day; for new donor-derived CAR T-cell infusion) will be administrated for 3 days.
15728946|NCT05032586|Device|wearing virtual reality headsets|"When the patient adapted to the headset and started to play games, he was taken to the dressing room with the VR headset and the application continued until the process was completed. Before starting the study, a pilot study was conducted to determine the time to wear headsets in ten children. It was observed that the children who were taken to the dressing room without wearing VR headsets refused to wear it. In order to prevent the child from experiencing anxiety in the dressing room, the child was put on VR headset in the patient room and then taken to the dressing room. After the procedure was completed, the VR headset was removed and the patient's oxygen saturation and heart rate were recorded on the Application Registration Form. The patients were asked regarding the pain and anxiety levels felt during dressing before and after the procedure and marked on the Wong Baker Scale, State-Trait Anxiety Inventory for Children and Children's Fear Scale."
15728947|NCT05032573|Dietary Supplement|Olive oil and Dietary Guideline recommendations|60 mL of olive oil and healthy diet recommendations
15728948|NCT05032573|Other|Dietary Guideline recommendations|healthy diet recommendations
15728951|NCT05032547|Behavioral|Therapist-supported digitally delivered transdiagnostic emotion regulation treatment|Please see description of experimental arm (arm one)
15728952|NCT05032547|Behavioral|Therapist-supported digitally delivered supportive treatment|Please see description of active comparator arm (arm two)
15728953|NCT05032534|Device|Cone Small, Qufora A/S|Newly developed cone in a softer material and a design matching the use for transanal irrigation.
15728954|NCT05032534|Device|Colotip, Coloplast A/S|Cone currently used for transanal irrigation at the Pediatric Ward, Aarhus University Hospital.
15728955|NCT05032521|Biological|collection of biological data|collection of biological data
15728956|NCT05032521|Other|collection of demographic, ventilatory, cardiac echocardiography, arterial and venous gas data|These data are usually measured continuously (monitoring of the resuscitation patient) and recorded on recorded on the resuscitation software.
15728957|NCT05032521|Procedure|Standard treatment|usual management based on the use of drugs according to international recommendations
15728958|NCT05032521|Procedure|stratified treatment according to algorithm|management based on arteriovenous CO2 gradient Stratification of drug use
15728959|NCT05032508|Drug|Lidocaïne Aguettant 20 mg/ml|Lidocaïne Aguettant 20 mg/ml, injectable solution, applied to the skin with an impregnated compress, applied 15 minutes before infiltration performed by an experienced operator.
15728960|NCT05032508|Drug|NaCl 0,9%|Placebo (NaCl 0,9%), applied to the skin with an impregnated compress, applied 15 minutes before infiltration performed by an experienced operator.
15728961|NCT05032495|Other|Surveys|Surveys to evaluate prior experience, opinions and intervention acceptability.
15728962|NCT05032495|Other|Focus group|To answer any questions and discuss topics covered in the standard presentation.
15728963|NCT05032482|Device|Investigational Treatment Mode (Stimulation Pattern)|Study participants will self-administer ~19-minute treatments twice daily in the home setting using non-invasive brainstem modulation device.
15728964|NCT05032469|Other|Reflexology|Reflexology is a method that creates nervous, hormonal and energetic effects in the body using pressure, rubbing and stretching applied with special hand and finger techniques to reflex points corresponding to all parts, organs and systems of the body in the ears, hands and feet
15728965|NCT05032456|Device|Oculus Quest All-in-one VR Gaming Headset (128 GB) VR system|The laboring women who enrolled in the VR group were offered to choose among several virtual environments including orange sunset, green meadows, black beginning, red savannah, blue deep, blue moon, blue ocean, white winter, and red fall. Cards printed out from the screenshots of the Nature Trek application representing these novel immersion options were provided to the patients to help them pick up their preferred environment in advance.
15728966|NCT05032443|Other|Awareness survey|The 33-item questionnaire will sent to pediatric endoscopy nurses in our country. Questionnaires will be delivered to nurses through hospital visits or electronic media.
15728967|NCT05032430|Behavioral|ATIENDE|A mix of mindfulness-based stress reduction, mindful eating, and mindful parenting strategies.
15729015|NCT05032144|Drug|Placebo|Intravenous injection
15729016|NCT05032144|Drug|STSA-1002 injection|Intravenous injection
15728968|NCT05032430|Behavioral|Modified Health Enhancement Program|Consists of strategies meant to enhance health and well-being (e.g., music therapy, health education) but does not include mindfulness as an active ingredient.
15728969|NCT05032417|Other|implementation of evidence-based nutrition practice guidelines|The comprehensive training includes the knowledge-focused training, plus access to the EBNPG virtual implementation toolkit. Due to the depth and breadth of the CKD EBNPG, which includes over 70 recommendations, consensus building discussions were conducted with key stakeholders, such as leadership from national dialysis companies and the Evidence Analysis Center guideline developers, to select five recommendations for patients on dialysis as the primary implementation focus for this project.
15728970|NCT05032404|Device|BNT103|BNT-103™ is a prescription digital therapeutic specifically designed to treat the symptoms of anxiety and depression related to cancer. There are 10 sessions provided over approximately 10 weeks.
15728971|NCT05032391|Biological|The pentavalent rotavirus vaccine (live attenuated oral, freeze-dried)|Three times orally in a volume of 2.5 ml (1 dose)
15728972|NCT05032391|Drug|Placebo|Three times orally in a volume of 2.5 ml (1 dose)
15728973|NCT05032378|Behavioral|Kinesthetic Awareness Training|One physical or occupational therapy session per week for 8 weeks during which the participant with disordered movement will attempt to perform desired movements while wearing the KAT device
15728974|NCT05032378|Behavioral|Provision of KAT-assisted physical or occupational therapy|Physical or occupational therapy professionals will provide one KAT-assisted therapy session per week for 8 weeks to one or more participants with movement disorder.
15728975|NCT05032365|Device|Close-loop FiO2 controller|Close-loop FiO2 controller software option provides automated adjustment of the ventilator Oxygen setting to maintain the patient's SpO2 in a defined target range. When using the software option, the user defines the SpO2 target range, as well as the SpO2 emergency limits, and the device adjusts the FiO2 setting to keep the patient's SpO2 in the target range.
15728976|NCT05032365|Device|Conventional|Conventional FiO2 adjustment by the clinician according to SpO2 values
15728977|NCT05032352|Drug|Adjuvant|Adjuvant treatment with a standard NSCLC platin-based doublet, 4 cycle (21-day) regimen of the investigator's choice (Arm 1) or other adjuvant therapy (Arm 1a) which can include combination of chemotherapy and targeted therapy, immunotherapy or other.
15728978|NCT05032352|Other|Observation|All patients will be observed for progression free survival and overall survival to the end of study or death, whichever occurs first.
15728979|NCT05032339|Other|IUO Plasma Cell Disorders Panel|This Investigational Panel , comprised of 2 reagents , is intended for in vitro diagnostic use for qualitative flow-cytometric immunophenotyping of plasma cell populations. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having, or suspected of having, plasma cell disorders.
15728980|NCT05032326|Drug|Follow-up study of the treated cohort|follow-up study of the patients in the treated cohort: that have been included in the otbb3 study
15728981|NCT05032326|Other|Follow-up study of the untreated cohort|follow-up study of the patients in the untreated cohort: that have NOT been included in the otbb3 study
15728982|NCT05032313|Other|IUO CLPD Limited Panel|This Investigational Panel , comprised of 2 reagents , is intended for in vitro diagnostic use for qualitative flow-cytometric immunophenotyping of mature lymphocyte populations. These reagents are used as an aid in the differential diagnosis of hematologically abnormal patients having Chronic Lymphoproliferative Disease .
15728983|NCT05032300|Device|Focused shockwave|Procedure: Focused shockwave therapy received shock wave therapy once a week: first locate, touch on the heel of the patient Tenderness points, take tenderness points as treatment points;Then ask the patient to take the lower limbs straight sitting or prone position, Target intensity will be within a range of 0.15-0.25 mJ/mm2 at maximum Hz, Total of 3000 pulses; rest for 20 minutes after the treatment
15728984|NCT05032300|Other|Home therapy|Stretching and ice massage
15728985|NCT05032287|Drug|Tamsulosin|Tamsulosin 0.4 mg once daily
15728986|NCT05032287|Drug|Placebo|Placebo once daily
15728987|NCT05032274|Other|Home-based Exercise Program|The exercise program will include chink tuck and shoulder retraction exercises. The chin tuck exercise will be performed in standing position. The shoulder retraction exercise includes activation and strengthening components. The activation component will be performed in standing position and strengthening component will be performed in prone position.
15728988|NCT05032261|Drug|Circulatory shock with norepinephrine in ICU|Circulatory shock with norepinephrine in ICU
15728989|NCT05032248|Drug|Tacrolimus ointment|oral gel
15728990|NCT05032235|Drug|Fluzoparib|Normal Renal Function:A single oral dose of Fluzoparib will be administered.
15728991|NCT05032235|Drug|Fluzoparib|Mild Renal Impairment:A single oral dose of Fluzoparib will be administered.
15728992|NCT05032235|Drug|Fluzoparib|Moderate Renal Impairment:A single oral dose of Fluzoparib will be administered.
15728993|NCT05032222|Other|Uroflowmetry|Diagnostic test
15728994|NCT05032209|Other|follow-up of children with severe asthma in adulthood|follow-up of children with severe asthma in adulthood
15728995|NCT05032196|Drug|WVE-003|WVE-003 is a stereopure antisense oligonucleotide (ASO)
15728996|NCT05032183|Drug|Cyclophosphamide|Given IV
15728997|NCT05032183|Drug|Cytarabine|Given IT
15728998|NCT05032183|Drug|Dexamethasone|Given IV or PO
15728999|NCT05032183|Biological|Filgrastim-sndz|Given SC
15729000|NCT05032183|Drug|Leucovorin|Given IV
15729001|NCT05032183|Drug|Mercaptopurine|Given PO
15729002|NCT05032183|Drug|Mesna|Give IV
15729003|NCT05032183|Drug|Methotrexate|Given IT
15729004|NCT05032183|Biological|Pegfilgrastim|Given SC
15729005|NCT05032183|Drug|Prednisone|Given PO
15729006|NCT05032183|Biological|Rituximab|Given IV
15729007|NCT05032183|Biological|Tagraxofusp-erzs|Given IV
15729008|NCT05032183|Drug|Vincristine|Given IV
15729009|NCT05032157|Drug|LOU064 (blinded)|LOU064 (blinded) active treatment
15729010|NCT05032157|Drug|Placebo|Placebo
15729011|NCT05032157|Drug|LOU064 (open-label)|LOU064 (open -label) active treatment
15729012|NCT05032144|Drug|STSA-1002 injection|Intravenous injection
15729013|NCT05032144|Drug|Placebo|Intravenous injection
15729014|NCT05032144|Drug|STSA-1002 injection|Intravenous injection
15729022|NCT05032131|Biological|ADSVF|Group 1 and 2 : Escalating dose of ADSVF injection (5 millions of cells, 10 millions of cells and 20 millions of cells).
15729023|NCT05032118|Drug|Ketamine Hydrochloride|Titratable ketamine infusion + low fixed-dose propofol.
15729024|NCT05032118|Drug|Propofol|Standard of care titratable propofol infusion.
15729025|NCT05032105|Device|Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA)|Unilateral Magnetic Resonance Imaging-guided Focused Ultrasound Ablation (MRgFUSA) of the anterior nucleus of the thalamus (ATN)
15729026|NCT05032092|Diagnostic Test|Next Generation Sequencing|Molecular analysis of liquid biopsy.
15729027|NCT05032092|Diagnostic Test|Next Generation Sequencing|Molecular analysis of tissue biopsy.
15729028|NCT05032092|Genetic|Biomarker Monitoring|Biomarker Monitoring of study patients receiving matched therapy.
15729029|NCT05032079|Procedure|cryoablation|single probe ultrasound guided cryoablation
15729030|NCT05032066|Drug|HZN-825|Two 150 mg oral tablets given in the morning with a meal and two matching placebo tablets given in the evening with a meal, total daily dose 300 mg HZN-825
15729031|NCT05032066|Drug|HZN-825|Two 150 mg oral tablets given in the morning with a meal and two 150 mg oral tablets given in the evening with a meal, total daily dose 600 mg HZN-825
15729032|NCT05032066|Drug|Placebo|Matching placebo tablets (2) given in the morning with a meal and matching placebo tablets (2) given in the evening with a meal, total daily dose 4 placebo tablets
15729033|NCT05032053|Drug|Antithrombotic drugs|The purpose of our study is to observe the effect of various antithrombotic drugs on the prognosis of ischemic stroke patients with cerebral microbleeds.
15729034|NCT05032040|Biological|XmAb20717|Monoclonal bispecific antibody
15729035|NCT05032027|Other|probiotics|recieving probiotics at the first day of chemoradiotherapy daily
15729038|NCT05032001|Drug|Biguanide, DPP4 inhibitors, SGLT2 inhibitors|Oral antidiabetic treatment during twelve weeks
15729039|NCT05031988|Other|No intervention will be used.|Determinants of physical activity and mental health among the students during Covid-19 movement restriction order will be assessed.
15729040|NCT05031975|Drug|Irinotecan|Irinotecan 100 mg/smq intravenous infusion every 14 days
15729041|NCT05031975|Drug|Temozolomide|Oral temozolomide 150 mg/sqm over days 1-5 every 28 days.
15729042|NCT05031962|Device|CELLIS Breast (Porcine Acellular Dermal Matrix, PADM)|Biological membrane used in breast reconstruction
15729043|NCT05031949|Combination Product|hyperbaric oxygen therapy plus Camrelizumab|Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody
15729044|NCT05031936|Procedure|cervical spinal injection with 0.2% ropivacaine|spinal injections performed in cervical pillar area to relieve chronic neck pain
15729045|NCT05031923|Procedure|SMV and antimicrobial photodynamic therapy|Application of SMV and antimicrobial photodynamic therapy in intrabony defects
15729046|NCT05031923|Procedure|SMV application|Application of SMV without antimicrobial photodynamic therapy in intrabony defects
15729047|NCT05031910|Other|Medical Device Usage and Evaluation|Undergo virtual reality imaging via VR/3D-CEPs
15729048|NCT05031910|Other|Best Practice|Receive standard of care
15729049|NCT05031910|Procedure|Resection|Undergo surgical resection
15729050|NCT05031897|Procedure|Hematopoietic Cell Transplantation|Undergo HSCT
15729051|NCT05031897|Drug|Mycophenolate Mofetil|Given IV
15729052|NCT05031897|Drug|Tacrolimus|Given IV
15729053|NCT05031897|Drug|Cyclophosphamide|Given IV
15729054|NCT05031897|Radiation|Total-Body Irradiation|Undergo TBI
15729055|NCT05031897|Procedure|Donor Lymphocyte Infusion|Undergo DLI
15729056|NCT05031897|Drug|Fludarabine|Given IV
15729057|NCT05031897|Drug|Melphalan|Given IV
15729058|NCT05031884|Device|MGIR3-US|MGIR3-US is an remote scanning robot which can do ultrasonic examinations.
15729059|NCT05031871|Drug|HR17031 injection ；INS068 injection；SHR20004 injection|HR17031 injection dose+INS068 injection dose+SHR20004 injection dose+(INS068+SHR20004) injection dose
15729060|NCT05031871|Drug|HR17031 injection ；INS068 injection；SHR20004 injection|INS068 injection dose+(INS068+SHR20004)injection dose+ HR17031 injection dose +SHR20004 injection dose
15729061|NCT05031871|Drug|HR17031 injection ；INS068 injection；SHR20004 injection|SHR20004 injection dose+ HR17031 injection dose +(INS 068+SHR20004) injection dose+ INS068 injection dose
15729062|NCT05031871|Drug|HR17031 injection ；INS068 injection；SHR20004 injection|(INS 068+SHR20004) injection dose+ SHR20004 injection dose+ INS068 injection dose+ HR17031 injection dose
15729063|NCT05031858|Other|Respiratory physiotherapy|Respiratory physiotherapy
15729064|NCT05031832|Diagnostic Test|HIV test|HIV test would be offered to self-reported HIV-negative / unknown HIV status MSM to confirm their HIV status
15729065|NCT05031819|Other|Nurse-led Task-Shifting Strategy for Hypertension Control (TASSH) plus Practice Facilitation.|"TASSH includes CVD risk assessment; medication initiation and titration; lifestyle counseling and patient referral to physician care for complex cases.
~Practice Facilitation includes the training of external experts to support the HIV nurses implementing TASSH"
15729100|NCT05031559|Behavioral|Compassion Training|Participants are invited to imagine themselves in someone else's situation, who is in a bad situation due to COVID-19 (e.g., ER nurse, family of someone in ICU). They are then reminded that their decisions have an impact on the occurrence of these situations.
15729070|NCT05031793|Other|TCM|TCM include oral chinese herb, laser acupuncture, tuina, nasal steam inhalation.
15729071|NCT05031793|Other|Western medicine|Western medicine include nasal spray steroid, oral antihistamine
15729072|NCT05031780|Drug|Mitapivat|Mitapivat tablets
15729073|NCT05031780|Other|Mitapivat-matching placebo|Placebo to match 50 mg or 100 mg tablets
15729074|NCT05031780|Other|Mitapivat-matching placebo|Placebo to match selected Phase 3 dose tablets
15729075|NCT05031767|Other|Usual care|"Conventional follow-up strategy with blood tests, patient-reported outcomes, and pre-scheduled visits at the hospital every 6th month.
~Continue using medical treatment with tumour necrosis factor inhibitors (TNFi). Patients will be instructed to use NSAIDs should they experience minor worsening of symptoms, but if the patients experience significant symptom worsening and suspect a severe disease worsening (flare) or adverse events, they will be instructed contact the hospital."
15729076|NCT05031767|Other|Remote monitoring|"Hospital health professionals perform remote monitoring of frequent patient-reported outcomes, blood test results, and physical activity data available on a digital platform.
~Continue using medical treatment with tumour necrosis factor inhibitors (TNFi). Patients will be instructed to use NSAIDs should they experience minor worsening of symptoms, but if the patients experience significant symptom worsening and suspect a severe disease worsening (flare) or adverse events, they will be instructed contact the hospital ."
15729077|NCT05031767|Other|Patient-initiated care|"No pre-scheduled visits or remote monitoring.
~Continue using medical treatment with tumour necrosis factor inhibitors (TNFi). Patients will be instructed to use NSAIDs should they experience minor worsening of symptoms, but if the patients experience significant symptom worsening and suspect a severe disease worsening (flare) or adverse events, they will be instructed contact the hospital."
15729078|NCT05031741|Other|Peer Leader Model|Teens will have an opportunity to interact with established peer leaders that are a part of the AccessKCTeen program. These leaders will receive a baseline training of their role, sexual and mental health. They will also receive health education and engage with a peer liason via text messages throughout the study.
15729079|NCT05031728|Behavioral|Cognitive Processing Therapy (CPT)|Cognitive processing therapy (CPT) (Resick et al., 2016) which is a specific type of cognitive behavioral therapy that has been effective in reducing symptoms of Post-Traumatic Stress Disorder (PTSD) that may have developed after experiencing a variety of traumatic events including child abuse, emotional abuse, combat, rape war, and natural disasters. CPT helps patients learn how to challenge and modify unhelpful beliefs related to the trauma and emotional pain. In so doing, the client creates a new understanding and conceptualization of the traumatic event so that it reduces its ongoing negative effects on current life.
15729080|NCT05031715|Dietary Supplement|Berberine Phytosome|2 tablets of 550 mg per day (1 before lunch and 1 before dinner)
15729081|NCT05031702|Dietary Supplement|Camellia Sinensis leaf extract|2 tablets per day of 150 mg (1 before lunch and 1 before dinner)
15729082|NCT05031702|Combination Product|Placebo|2 tablets per day of 150 mg (1 before lunch and 1 before dinner)
15729083|NCT05031689|Biological|SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract|Control Group will use SPF 30 sunscreen plus pharmaceutical formulation without green banana peel extract
15729084|NCT05031689|Biological|SPF 30 sunscreen and pharmaceutical formulation containing green banana peel extract|Study Group In addition to the SPF 30 sunscreen, a pharmaceutical formulation containing green banana peel extract will be used.
15729085|NCT05031676|Other|opioid free anesthesia|Maintenance of anesthesia was done with halothane. The incision was allowed at 1.2 MAC of halothane. This halogen was administered according to the hemodynamic parameters and the habits of the anesthesia team. Before waking up, all the patients benefited from preventive analgesia with 1 g paracetamol combined with 20 mg nefopam by slow intravenous injection over approximately 15 minutes.
15729086|NCT05031663|Dietary Supplement|Almond group|Participants in the Almond group will receive 15% of their daily energy intake in the form of almonds as a snack
15729087|NCT05031663|Dietary Supplement|Control Group|Participants in the control group will receive an isocaloric carbohydrate based commercial snack (pretzel)
15729088|NCT05031650|Procedure|openCPAP|Randomized to : Individualized high level CPAP between 8-10 cmH2O pressure
15729089|NCT05031650|Procedure|standardCPAP|Randomized to : Standard level CPAP between 6-8 cmH2O pressure
15729090|NCT05031637|Behavioral|treatment of BP by using night-time BP|titration of BP medications to target according to night-time SBP
15729091|NCT05031637|Behavioral|treatment of BP by using daytime BP|titration of BP medications to target according to daytime SBP
15729092|NCT05031624|Drug|CDX-0159|Single subcutaneous dose of one of four dosages of CDX-0159
15729093|NCT05031624|Drug|Normal saline|Single subcutaneous dose of normal saline
15729094|NCT05031611|Behavioral|Intuitive Eating Treatment|"Participants received a brief web-based intervention for disordered eating which focused on a style of eating behavior called intuitive eating. Please see arm description for more details."
15729095|NCT05031598|Other|Long-term fasting according to the Buchinger Wilhelmi fasting program|the participants will undergo a fasting program that includes the daily intake of 250 kcal under medical supervision
15729096|NCT05031585|Device|Roncoliv|The medical device with nasal spray solution should be used 1 time a day, before bedtime, for 30 days.
15729097|NCT05031585|Device|Placebo|The medical device with placebo should be used 1 time a day, before bedtime, for 30 days.
15729098|NCT05031572|Other|dietary intervention|Chronic caloric restriction diet vs intermittent fasting on energy sensing metabolites and metabolic homeostasis
15729099|NCT05031559|Behavioral|Episodic Future Thinking|Participants are invited to imagine themselves in a positive situation after COVID-19 public health restrictions and guidelines are lifted. They are then reminded that their actions are able to change how soon this future can be achieved.
15729101|NCT05031559|Behavioral|Sham|Participants are invited to reflect on some COVID-19 related news, and reminded that their actions have bearing on the COVID-19 situation.
15729103|NCT05031533|Radiation|Dose-Painting Radiation|"Radiation therapy:
~Delineation of target area:
~The primary tumor is delineated into different target areas according to the anatomical position of the tumor, including the central area tumor GTV-Tcentral and GTV-Tperipheral.
~Exposure dose:
~1) GTV-Tcentral: 2.0～2.5Gy/f, bid, 10-13d, physical dose 40-65Gy 2) GTV-Tperipheral: 3.0～4.0Gy/f, bid, 10-13d, physical dose 60-104Gy 3) GTV-N (mediastinal lymph node): 2.0Gy/f, bid, 10-13d, physical dose 40-52Gy"
15729104|NCT05031520|Procedure|Coronary computed tomography angiography (CCTA)|Participants will undergo CCTA. CCTA performed in this study will be technically identical to CCTA that is commonly performed in clinical practice, for which safety profiles are well defined. Guidelines implemented by the National Institutes of Health Radiation Exposure Committee will be followed. Major risks of CCTA include exposure to ionizing radiation, the requirement for intravenous catheter placement and contrast media administration, and side effects of beta-blockers and nitrates that may be used for vasodilation and heart rate control to optimize CCTA image quality.
15729105|NCT05031520|Drug|Isovue|CCTA requires intravenous catheter placement and the administration of iodinated contrast media (Isovue).
15729106|NCT05031520|Drug|Nitroglycerin|Medication to promote coronary vasodilation during the CCTA may be administered immediately prior to CCTA to optimize image quality
15729107|NCT05031520|Drug|Metoprolol|Medication to promote heart rate reduction during the CCTA may be administered immediately prior to CCTA to optimize image quality
15729108|NCT05031494|Drug|YH003|YH003 will be dosed at 0.3 mg/kg every 3 weeks. The first infusion of YH003 should be administered over 60 minutes.
15729109|NCT05031494|Drug|Toripalimab|Toripalimab will be administered at a dose of 240 mg every 3 weeks.
15729110|NCT05031494|Drug|Nab-paclitaxel|Nab-paclitaxel will be administered each 21-day cycle.
15729111|NCT05031494|Drug|Gemcitabine|Gemcitabine will be administrated each 21-day cycle.
15729112|NCT05031481|Drug|Venus 20 + 0,064|Venus vaginal cream 20 + 0,064, single-dose.
15729113|NCT05031481|Drug|Venus 20 + 1|Venus vaginal cream 20 + 1, single-dose.
15729114|NCT05031481|Drug|Venus 20 + 4|Venus vaginal cream 20 + 4, single-dose.
15729115|NCT05031481|Drug|Butoconazole nitrate|Butoconazole nitrate vaginal cream, 100 mg single-dose.
15729116|NCT05031468|Biological|Licensed or EUA SARS-CoV-2 vaccine|Several SARS-CoV-2 vaccines utilizing different platforms (e.g., mRNA, viral vector, etc.), are available under EUA (and soon to be licensed) and are being administered to individuals who are pregnant or postpartum who belong to high-risk priority groups for vaccination. Participants will receive the SARS-CoV-2 vaccine of their choice or the type that is available to them. The researchers anticipate including up to 4 vaccines as part of this non-interventional study.
15729117|NCT05031455|Biological|Dupilumab|"Dupilumab is a fully human monoclonal antibody that blocks the receptor component for IL-4 and IL-13, which are key drivers of type 2 inflammation.
~8 of 16 subjects will randomly receive dupilumab. All subjects will undergo an aspirin challenge/desensitization procedure. To achieve adequate steady state levels of dupilumab, the dosing regimen will be a 600mg loading dose of dupilumab followed by 300mg subcutaneous at 1 week, 3 weeks and 5 weeks. Aspirin challenge/desensitization will take place at week 6 after dupilumab loading dose."
15729118|NCT05031455|Drug|Placebo|8 of 16 subjects will randomly receive placebo. All subjects will undergo an aspirin challenge/desensitization procedure. The dosing regimen will be a 600mg loading dose of dupilumab followed by 300mg subcutaneous at 1 week, 3 weeks and 5 weeks. Aspirin challenge/desensitization will take place at week 6 after placebo loading dose.
15729124|NCT05031416|Combination Product|LTQ|The investigators will test the LTQ-Connect application and a standard 10-week course of nicotine replacement therapy (NRT) nicotine patches, and Facebook groups, which will run for a total of 3 months with research study participants
15729125|NCT05031403|Other|Telerehabilitaton|Patients will be asked to apply the rehabilitation program defined for them 3 days a week for 8 weeks. A training session will last approximately 45-60 minutes.
15729126|NCT05031403|Other|Home Exercise|Patients will be asked to apply the rehabilitation program for themselves with an exercise brochure. This therapy will last 3 days a week for 8 weeks.
15729127|NCT05031390|Procedure|Physiotherapist-led training|Patients will undergo a 12-week physiotherapist-led training program consisting of 8 supervised sessions and home-based training in between
15729128|NCT05031377|Behavioral|HE programme|Participants will receive a 12-week integrated exercise and cardiovascular health education programme (HE programme) which is constructed based on self-efficacy theory. A booster intervention in the form of SMS messaging will be given from Week 1 to Week 12.
15729129|NCT05031377|Behavioral|Usual care|Participants will receive usual care which primarily includes an education talk on basic health issues. Governmental health education leaflets will be provided for reference.
15729130|NCT05031364|Behavioral|Behavioral Interventions for Anxiety in Children with Autism (BIACA)|In the BIACA CBT program (e.g., Wood et al., 2020), clinicians work with families for 16 weekly sessions that include both the child and parent(s). In BIACA, anxiety, rigidity and inflexible routines, and irritability are all addressed using in vivo exposure therapy strategies during sessions as well as parent (and teacher) training to promote regulation across settings. ASD-related clinical needs that can impact mental health and emotion regulation such as friendship skills and social entry skills (e.g., joining games at school) are addressed with modeling, self-management, and parent- (or teacher-) implemented social coaching in daily settings. For youth with limited communication, therapy is adapted through the use of play-based representations of challenging situations and an emphasis on more action-oriented exposure therapy.
15729158|NCT05031104|Other|Physical Exercise|The control group received a standard exercise program for 40 minutes, three times a week for three successive months. The program encompassed aerobic, weight-bearing, proprioceptive, flexibility, and strengthening exercises.
15729289|NCT05030077|Drug|Gemcitabine|Gemcitabine ( 1000 mg/m2) IV days 1 and 8
15729131|NCT05031364|Behavioral|Treatment-as-Usual Supplemented by Internet-Based Self-Instruction (MEYA)|Participating clinicians are expected to have varied training in numerous psychological therapy procedures (e.g., insight-oriented procedures, cognitive interventions, family therapy, etc.), any or all of which they may choose to implement with a participating child. These practices will be characterized through the Therapy Procedures Checklist (Weersing et al., 2002). Additionally, participating clinicians will be provided with information about self-instruction resources on CBT for children with autism, namely, the Modular Evidence-Based Practices for Youth with Autism (MEYA) website developed by our research group. MEYA is freely accessible to clinicians worldwide at meya.ucla.edu. MEYA incorporates treatment elements of both BIACA (Wood et al., 2020) and SEBASTIEN (Wood et al., 2021), which was designed to address additional autism-related clinical needs (e.g., reciprocal conversation). Clinicians in this arm will provide up to 16 therapy sessions.
15729132|NCT05031351|Drug|Withania somnifera|Nuclear Factor Kappa Beta Inhibitor
15729133|NCT05031351|Drug|Placebo|Placebo Comparator
15729134|NCT05031338|Device|Carpal Tunnel Release|Carpal Tunnel Release surgery involves transecting the transverse carpal ligament (TCL) in order to reduce median nerve compression and alleviate symptoms. The carpal tunnel release surgery will be performed using the SX-One MicroKnife with ultrasound guidance.
15729135|NCT05031338|Procedure|Carpal Tunnel Release|Carpal Tunnel Release surgery involves transecting the transverse carpal ligament (TCL) in order to reduce median nerve compression and alleviate symptoms. The carpal tunnel release surgery will be performed using the traditional mini-open technique without ultrasound guidance.
15729136|NCT05031325|Device|Endoscopic submucosal dissection with Purastat|Purastat (peptidic gel) application
15729137|NCT05031312|Procedure|inferior oblique weakening|inferior oblique myectomy versus inferior oblique anterior nasal transposition in superior oblique palsy treatment
15729138|NCT05031299|Behavioral|Standard care|Participants will receive only the standard care as provided by the local and national healthcare system as well as one face-to-face counselling session for lifestyle modification to improve their risk factors.
15729139|NCT05031299|Behavioral|Health-promotion application for self-management|Participants will be provided with a health-promotion application for self-management for 3 months, additionally to the standard care.
15729140|NCT05031299|Device|Wearables and devices|Participants will be provided with wearables and devices, including a weighing scale (assessing also body composition) device and a smartwatch/wristband to assess physical activity but also sleep pattern, for 3 months, additionally to the standard care and the Health-promotion application.
15729141|NCT05031286|Other|Cutaneous thermal stimuli|Application of thermal stimuli of different intensities to the skin
15729142|NCT05031273|Behavioral|Residents moving into a congregate-living development with more features that support healthy living|Our team is making evidence-based recommendations to the developer and design team of an upcoming congregate-living development to support the physical activity, healthy eating, and social connections of residents moving into the new building(s). We hope for the developer to integrate into the new building(s) as many as possible of our team's built environment design and amenity recommendations into their site and/or building plans. Additionally, discussions with the municipality are also occuring on built environment design and amenity recommendations to improve the neighbourhood surrounding the site. Although our team has provided these recommendations, it is ulimatily up to the discretion of the developer and the municipality as to whether and what design and amenity changes are made.
15729143|NCT05031260|Device|applying COMORAL®|The individuals in the experimental group will be asked to come to the clinic to use COMORAL® three times a day, every day except Saturday and Sunday.
15729144|NCT05031247|Other|Wellbeing Program|The community navigator program was developed during a three-phase community-based participatory research project that aims to examine emotional/mental health needs and address access to mental health services among immigrants and refugees from Muslim-majority countries.
15729145|NCT05031234|Drug|anaesthesia without opiates|Anaesthesia without opiates for patients undergoing laparoscopic colectomy
15729146|NCT05031234|Drug|anaesthesia with morphine|anaesthesia with morphine for patients undergoing laparoscopic colectomy
15729147|NCT05031221|Behavioral|Yoga + behavioral weight loss|A 12-week, one-arm proof-of-concept and feasibility study will be conducted at the University of Colorado Anschutz Medical Campus (CU-AMC) to assess the processes critical for the success of future randomized trials including: a) Evaluating the feasibility and acceptability of adding a multi-component yoga program to a standard BWL intervention and b) Examining pre-post changes in relevant clinical/cardiometabolic, psychological, and energy balance/behavioral outcomes to inform the design of future trials. Participants will receive a comprehensive, group-based BWL intervention consistent with current guidelines for obesity treatment and a carefully designed multi-component yoga intervention delivered through pre-recorded videos delivered through a cloud-based platform that will be completed in-person and at-home (BWL+yoga).
15729148|NCT05031208|Diagnostic Test|Memory task|Word recognition task
15729149|NCT05031195|Other|1st tertile, 2nd tertile, 3rd tertile|Patients will be divided into 3 groups according to the preoperative NLR value.
15729152|NCT05031169|Procedure|interdental papilla surgical reconstructiion|Surgical treatment of receding interdentalpapillae
15729153|NCT05031156|Procedure|Splinting of OT Bridge system|splinting of implant abutment using titanium wire followed by pick up using the patient's denture
15729154|NCT05031143|Drug|Suprachoroidal Triamcinolone acetonide injection for serous retinal detachment in VKH disease|Suprachoroidal steroid injection for management of serous retinal detachment in VKH disease
15729155|NCT05031130|Other|Empowered program integrated with family support|The empowered program integrated with family support is an intervention consisted of five steps that will be given when pregnant adolescents on gestational age 32 or 33 weeks the second meeting will be when the pregnant adolescents on gestational age 34 or 35 weeks.
15729156|NCT05031117|Procedure|Conventional Epidural Technique|Standard Lumbar Epidural Technique at L4-5 interspace using Tuhoy needle (18G) then epidural catheter (20G) inserted, then 15ml 0.5% Bupivacane and 50ug fentanyl given.
15729157|NCT05031117|Procedure|25G Dural Puncture Epidural Technique|25G pencil point spinal needle will be inserted at L4-5 interspace through the tuhoy needle
15729159|NCT05031104|Other|Physical Exercise plus Low-energy Laser Therapy|The LLT group received the same program in addition to the application of LLT on both knees, each session before exercises.
15729160|NCT05031091|Other|standardised exposure questionnaire|A standardised exposure questionnaire will be conducted face to face or by telephone. The search for risk factors for leprosy and in particular direct or indirect contact with armadillos will be explored
15729161|NCT05031078|Biological|Gardasil|"Participants will receive 3 doses of 9-valent HPV vaccine (Gardasil 9) at D0, D60, and D180 The 9-valent HPV vaccine, or Gardasil-9, is a non-infectious recombinant vaccine prepared from the purified virus-like particles (VLPs) of the major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58.
~Gardasil-9 is supplied as a 0.5-mL single-dose vial or 0.5-mL single-dose prefilled Luer Lock syringe with tip cap."
15729162|NCT05031078|Drug|Lidocaine injections|"1-2% lidocaine injections.
~1% lidocaine, an FDA approved local anesthetic, will be injected subcutaneously to numb the area of the lymph node being sampled; whereas 2% lidocaine will be injected into the tissue surrounding the area where the bone marrow will be removed. In adults the recommended dose is 7 mg/kg with a maximum of 500 mg."
15729163|NCT05031065|Radiation|Breast Cancer Radiotherapy|4000-4250 cGy in 15-16 daily fractions
15729164|NCT05031052|Device|End-ischemic normothermic oxygenated machine perfusion|Application of end-ischemic normothermic oxygenated machine perfusion at physiological temperatures for 4 hours.
15729165|NCT05031052|Procedure|Static cold storage|Immediate implantation of kidney allograft after conventional and static preservation on ice
15729166|NCT05031026|Drug|Dexmedetomidine|dexmedetomidine infusion rule in prevention of IRI
15729167|NCT05031026|Drug|Normal Saline|normal saline infusion as a placebo
15729168|NCT05031000|Diagnostic Test|blood glucose measurement: POCT|measurement of blood glucose concentration using 5 different POCT glucometer
15729169|NCT05031000|Diagnostic Test|blood glucose measurement: reference|measurement of blood glucose concentration using 2 different laboratory analyzer
15729170|NCT05030987|Procedure|Renal Denervation|Renal denervation in patients with HFpEF and uncontrolled hypertension
15729171|NCT05030987|Procedure|Sham|Sham Treatment. After six months, cross-over is planned in all sham-treated patients and this patients will also receive a renal denervation.
15729172|NCT05030974|Biological|mRNA-1273|SARS-CoV-2 vaccination
15729173|NCT05030974|Biological|Ad26.COV2.S vaccine|SARS-CoV-2 vaccination
15729174|NCT05030961|Behavioral|Virtual team-based clinic|Virtual team-based clinic will include consultation, counseling, and education from pediatric audiology, psychology, auditory verbal therapy, and education. Each session lasts approximately 30 minutes with a total of 3 sessions within the year.
15729175|NCT05030961|Behavioral|Remote cochlear implant programming|Remote cochlear implant programming will be provided via Zoom on a study-provided encrypted laptop.
15729176|NCT05030948|Behavioral|Tiempo Juntos Intervention|"If assigned to this group, participants will take part in weekly 1-hour group sessions twice a week for 3 months. The sessions will be with a trained Community Health Worker that will involve group (5-6 participants) moderate-intensity walking. Upon completing the 3 months of physical activity sessions, for the next 3 months, they will receive motivational booster sessions delivered every other week via phone calls/text messaging."
15729177|NCT05030935|Device|mHealth App|In short, mHA contains three main functions for the user: a) a reminder for switching the patient position, b) training for preventive care habits and c) the possibility for patient evaluation in order to determine the need for the use of support surfaces.
15729178|NCT05030922|Other|Antiatherogenic diet|Participants instructed in antiatherogenic diet during pregnancy with frequent follow-ups to ensure compliance
15729179|NCT05030909|Behavioral|transdiagnostic group treatment|The individual and group sessions will integrate core principles from Motivational interviewing (provide information, address barriers), Cognitive Behavioural Therapy (psychoeducation regarding emotions, enhancing emotional awareness, cognitive restructuring, behavioural experiments, relaxation) , Acceptance Commitment Therapy (mindfulness, grounding, emotional and body awareness, enhancing cognitive flexibility), and aspects of Islamic psychology.
15729180|NCT05030896|Other|Invasive treatment and exercise therapy|The subjects of experimental group will perform therapeutic exercise program and they will be receive Percutaneous Electrolysis therapy and the subjects of experimental group will perform the same exercise program and they will be receive only needling puncture
15729181|NCT05030883|Behavioral|Source of news|The main intervention was the source of the news that was shown to participants
15729182|NCT05030870|Device|Capnography monitoring|Standard monitoring and capnographic monitoring.
15729183|NCT05030870|Device|Standard monitoring|Standard monitoring but no capnographic monitoring
15729184|NCT05030857|Drug|GLPG4716|From Day 3 to Day 14, participants will receive GLPG4716 tablets once daily in fasted state. On Day 8 GLPG4716 will be administered in fed state.
15729185|NCT05030857|Drug|Midazolam|On Days 1, 3 and 13, participants will receive a single oral dose of MDZ as an oral solution in fasted state.
15729187|NCT05030831|Drug|INZ-701|Recombinant fusion protein that contains the extracellular domains of human ENPP1 coupled with an Fc fragment from an immunoglobulin gamma-1 (IgG1) antibody (rhENPP1-Fc)
15729188|NCT05030818|Drug|Polypill of acetylsalicylic acid, ramipril and atorvastatin|Administration of acetylsalicylic acid, ramipril and atorvastatin in a polypill during 3 months more
15729189|NCT05030818|Drug|Drugs taken separately: acetylsalicylic acid, ramipril and atorvastatin|Patients will be receiving during 3 months more the same components acetylsalicylic acid, ramipril and atorvastatin than with the polypill
15729191|NCT05030779|Biological|Assigned Interventions CD19/BCMA CAR T-cells|Drug: CD19/BCMA CAR T-cells Each subject receive CD19/BCMA CAR T-cells by intravenous infusion Other Name: CD19/BCMA CAR T-cells injection
15729192|NCT05030766|Drug|Nicotine Replacement Therapy|6 weeks of Nicotine replacement patches
15729193|NCT05030766|Behavioral|Mindfulness Training Smoking Cessation Intervention|Mindfulness Training Smoking Cessation Intervention administered online via Zoom. Each session lasts 60-90 minutes, twice weekly for 4 weeks for a total of 8 sessions.
15729194|NCT05030766|Behavioral|Contingency Management Smoking Cessation Intervention|Contingency Management Smoking Cessation Intervention includes one orientation session lasting about 60-90 minutes administered via Zoom. Participants will then be required to contact the research associate about their quitting progress three times a week for 4 weeks also by zoom.
15729195|NCT05030753|Behavioral|iSIPsmarter|iSIPsmarter is a technology-based behavioral and health literacy intervention. It is comprised of six Internet-delivered Cores, an integrated short message service (SMS) strategy to engage users in tracking SSB behaviors, and the incorporation of a cellular enabled scale for in-home weight tracking. Participants will be prompted (via email or text) to self-monitor their sugar-sweetened beverage intake. iSIPsmarter is a highly interactive, structured, and self-guided program that uses strategies previously proven to promote behavior change. iSIPsmarter also incorporates a stepped care approach to re-engage users who struggle to complete components.
15729196|NCT05030753|Behavioral|Patient Education (PE)|he PE website will include scientifically accurate information that is typical of nutrition education websites and will include information about SSB recommendations, types of SSB and portion size, SSB-related health risks, energy balance information, identifying personal motivators and barriers to reducing SSB intake, interpreting SSB nutrition labels, and recognizing media influences and misclaims in SSB advertisements, as well as printable forms to track SSB and weight. Unlike iSIPsmarter, the content will not be tailored and will be presented all at once.
15729197|NCT05030727|Diagnostic Test|record of pNGAL|Preoperative (0.hour baseline), postoperative 24.,48. BUN, Creatinine, Lactate values in the blood of the patients at 1 hour, and for plasma NGAL, blood samples will be taken at the preoperative, postoperative 6th and 24th hours. And the results will be recorded.
15729198|NCT05030714|Diagnostic Test|Visual Field Testing|Visual field testing using the protocol 24-2 and/or 10-2 Threshold Test
15729199|NCT05030688|Other|Postoperative analgesia management|Intravenous 0.5 mg/kg tramodol and 400 mg ibuprofen will be administered to all patients 30 minutes before the end of the surgical procedure. In the postoperative period, patients will be administered ibuprofen iv 400 mg 3x1. If the NRS score is ≥ 4, 0.5 mg kg-1 iv meperidine will be administered as a rescue analgesic.
15729200|NCT05030675|Drug|Fostamatinib|Given PO
15729201|NCT05030662|Other|Walking stick exercise|"Education of walking stick exercise by research nurses twice before discharge (on the day before surgery and before discharge)
~The video clip of walking stick exercise is available to the patients.
~The research nurses encourage our patients to keep rehabilitation by phone calls once a week after discharge."
15729202|NCT05030649|Device|Smart glasses|The real-time ultrasound image is displayed through head-mounted display Moverio BT-300 (Epson Inc., USA) during the radial arterial cannulation.
15729203|NCT05030649|Device|Control|The real-time ultrasound image is displayed by the ultrasound machine's monitor during the radial arterial cannulation.
15729204|NCT05030636|Procedure|Acute moderate to vigorous exercise performed at a specific moment of the day|Treadmill (30 minutes) at 70% of maximal aerobic capacity
15729205|NCT05030623|Drug|Tadalafil 5Mg Tab|Tadalafil 5Mg Tab plus Fluoxetine 20 mg capsule
15729206|NCT05030623|Drug|Placebo|Placebo Tab plus Fluoxetine 20 mg capsule
15729207|NCT05030610|Behavioral|BeatIt-ASD|BeatIt-ASD, designed to be implemented with autistic individuals, is an adaptation of BeatIt. The intervention aims to improve mood and decrease depressive symptoms through an increase in meaningful engagement in recreational, domestic, and social/leisure activities.
15729208|NCT05030597|Drug|68Ga-DOTA-FAPI|Intravenous access is pre-established. Quality control is carried out to confirm the radiochemical purity of 68Ga-DOTA-FAPI by HPLC. Intravenous administration of 68Ga-DOTA-FAPI according to 1.85-3.7 MBq/kg body weight (0.05-0.1 mCi/kg), rinsed with 0.9% saline, and hydrated after drinking more water.
15729209|NCT05030597|Device|PET/CT|Each subject undergoes PET/CT imaging within 20-30 minutes after injection.
15729210|NCT05030584|Drug|Elinzanetant (BAY3427080)|120 mg elinzanetant orally once daily
15729211|NCT05030584|Drug|Placebo|Matching placebo orally once daily.
15729212|NCT05030571|Device|DPMAS|DPMAS circuit consist of Plasmaflo OP cartridge (Asahi Medical, Tokyo, Japan), Ion exchange resin hemoperfusion cartridge (BS330; Jafron, Zhuhai City, China), and Neutral adsorption resin hemoperfusion cartridge (HA330-II; Jafron, Zhuhai City, China)
15729213|NCT05030571|Other|standard treatment|standard treatment according to EASL Clinical Practical Guidelines on the management of acute (fulminant) liver failure 2017.
15729214|NCT05030558|Behavioral|Web-assisted patient education intervention designed according to the common-sense model|Implementation of patient education with the website created about fibromyalgia disease in 4 weeks according to the disease perception themes reached as a result of the qualitative research.
15729215|NCT05030558|Behavioral|The website where the Turkish Physical Medicine and Rehabilitation Association Fibromyalgia patient booklet is available as pdf.|The website where the Turkish Physical Medicine and Rehabilitation Association Fibromyalgia patient booklet is available as pdf.
15729216|NCT05030545|Drug|Eplerenone|After baseline cardiac imaging with PET and echocardiogram, participants will be treated with eplerenone for 6 months at a starting dose of 50mg daily and up to a maximally tolerated dose of 100mg daily, followed by repeat imaging with PET and echocardiogram.
15729217|NCT05030532|Behavioral|EVERYbody Project|Brief behavioral group intervention (4 hours across two meetings)
15729218|NCT05030532|Other|Video + Expressive Writing|Brief video-based group intervention (4 hours across two meetings)
15729220|NCT05030506|Drug|Belzutifan|40 mg tablet administered orally at a dose of 120 mg
15729221|NCT05030506|Biological|Pembrolizumab|25 mg/mL solution for Infusion in a single-dose vial administered intravenously at a dose of 400 mg
15729222|NCT05030506|Drug|Lenvatinib|10 mg capsule administered orally at a dose of 20 mg
15729287|NCT05030077|Drug|Cisplatin|Cisplatin (70 mg/m2) IV day 1
15729223|NCT05030493|Drug|mFOLFOX6 + panitumumab combination therapy|oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab oxaliplatin (OXA), levofolinate calcium (l-LV), panitumumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion
15729224|NCT05030493|Drug|mFOLFOX6 + bevacizumab combination therapy|oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumab oxaliplatin (OXA), levofolinate calcium (l-LV), bevacizumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion
15729225|NCT05030480|Diagnostic Test|renal functions|urea, creatinine, GFR
15729226|NCT05030467|Behavioral|REDUCE-BP Intervention|"Pre-visit:
~Providers in the intervention arm will receive dashboards which will highlight racial/ethnic differences in rates of achieving blood pressure control within their patient panel. The dashboard will also provide individual-level information for patients with poorly controlled blood pressure.
~During visit:
~Providers will receive clinical decision support within relevant patients' charts that highlight the patient's under-treated blood pressure and potential impacts of social needs.
~Providers will have the opportunity to provide enhanced patient education materials, which can be automatically ordered within the clinical decision support.
~Post-visit:
~Patient-subjects' access to the online patient portal will be streamlined by the inclusion of information about the patient portal in the patients' after-visit summary. Providers will also be able to referral patients automatically to nurse BP visits."
15729229|NCT05030441|Drug|Ivosidenib|. Patients should take ivosidenib at approximately the same time every day, with or without food, but should be instructed to avoid a high-fat meal as well as grapefruit and grapefruit products.
15729230|NCT05030428|Drug|Inclisiran sodium 300 mg|Subcutaneously injected on Day 1, Month 3 (Day 90) and every 6 months thereafter until EOS visit
15729231|NCT05030428|Drug|Placebo|Subcutaneously injected on Day 1, Month 3 (Day 90) and every 6 months thereafter until EOS visit
15729232|NCT05030415|Drug|Ixekizumab Auto-Injector|160 mg week 0 followed by 80 mg every two weeks
15729233|NCT05030402|Procedure|Maitland|An assessment is carried out at the beginning of the treatment, at the end and 2-4 weeks after finishing the treatment. The EVA ASES, DASH and SF-36 scales are included and the biomechanics study is used for the range of mobility.
15729234|NCT05030402|Procedure|Tens, exercise, SW|An assessment is carried out at the beginning of the treatment, at the end and 2-4 weeks after finishing the treatment. The EVA ASES, DASH and SF-36 scales are included and the biomechanics study is used for the range of mobility.
15729235|NCT05030402|Procedure|Conventional physiotherapy|An assessment is carried out at the beginning of the treatment, at the end and 2-4 weeks after finishing the treatment. The EVA ASES, DASH and SF-36 scales are included and the biomechanics study is used for the range of mobility.
15729236|NCT05030389|Behavioral|Adapted Physical Activity (APA)|The APA program lasts 12 weeks and consists in three one-hour at-home sessions a week (total of 36 sessions), including two aerobic dominant web-based sessions and one muscle strengthening self-guided session.
15729237|NCT05030389|Behavioral|Bright Light Exposure (BLE)|Bright light exposure (BLE) consists in using lamps for light therapy during 12 weeks, at the rate of five one-hour at-home sessions a week.
15729238|NCT05030389|Behavioral|Galvanic Vestibular Stimulation (GVS)|The GVS program lasts 2 weeks and consists in five 20-minutes at-home sessions a week (total of 10 sessions), using a portable galvanic stimulator.
15729239|NCT05030389|Behavioral|Health Education program (HE)|The HE program lasts 14 weeks and consists in one one-hour at-home session a week (total of 14 sessions). This web-based intervention includes courses on general health (sleep habits, diet, physical activity, cardiovascular diseases, etc.).
15729241|NCT05030363|Drug|ALDH enzyme supplementation|ALDH enzyme (PICOZYMEQ™)
15729242|NCT05030350|Drug|PH94B|Nasal spray
15729243|NCT05030337|Device|Closed-loop automated oxygen control (Oxygenie, SLE 6000)|The OxyGenie closed-loop oxygen saturation monitoring software (SLE) uses oxygen saturations from the SpO2 probe attached to the neonate, fed into an algorithm, to automatically adjust the percentage of inspired oxygen to maintain oxygen saturations within the target range. Manual adjustments including the percentage of FiO2 will be allowed at any point during the study if deemed appropriate by the clinical team.
15729244|NCT05030324|Drug|XC221 100 mg|Regardless of the group, all study subjects will receive the standard symptomatic therapy for influenza and other viral URIs, taking into account the latest clinical guidelines (the necessity of symptomatic therapy will be decided by the Investigator).
15729245|NCT05030324|Drug|XC221 200 mg|Regardless of the group, all study subjects will receive the standard symptomatic therapy for influenza and other viral URIs, taking into account the latest clinical guidelines (the necessity of symptomatic therapy will be decided by the Investigator).
15729246|NCT05030324|Drug|Placebo|Regardless of the group, all study subjects will receive the standard symptomatic therapy for influenza and other viral URIs, taking into account the latest clinical guidelines (the necessity of symptomatic therapy will be decided by the Investigator).
15729247|NCT05030311|Drug|LOU064 (blinded)|LOU064 (blinded) active treatment
15729248|NCT05030311|Drug|Placebo|Placebo
15729249|NCT05030311|Drug|LOU064 (open-label)|LOU064 (open-label) active treatment
15729250|NCT05030298|Radiation|Radiation Therapy|Undergo radiation therapy
15729251|NCT05030298|Radiation|Radiosurgery|Undergo radiosurgery
15729252|NCT05030298|Procedure|Stereotactic Biopsy|Undergo MRI-guided stereotactic biopsy
15729253|NCT05030298|Drug|Temozolomide|Drug
15729254|NCT05030298|Procedure|Therapeutic Conventional Surgery|Undergo surgery
15729255|NCT05030298|Procedure|Tumor Treating Fields Therapy|Undergo TTF
15729256|NCT05030285|Behavioral|Cognitive Behavioral Therapy (CBT)|The CBT intervention includes 6 sessions via video-conferencing that has been tailored for people living with cognitive impairment. The sessions incorporate the use of psychoeducation and relaxation videos to improve home-based practise for long-term outcomes.
15729288|NCT05030077|Drug|Carboplatin|If the patients can't tolerate cisplatin, they will be treated with carboplatin (AUC 4.5mg/mL·min) IV day 1
15729262|NCT05030259|Procedure|fasciotomy|To perform fasciotomy
15729263|NCT05030246|Drug|Surufatinib/Toripalimab|Surufatinib 250mg will be taken orally once daily continuously through a 21-day cycle of study treatment. Toripalimab 240mg will be intravenously administered on Day 1 of each cycle.
15729264|NCT05030233|Behavioral|Nurse-Administered Touch Intervention|The nurse-administered touch intervention is a bare-handed, comforting touch intervention administered during an episode of essential nursing care. The bedside nurse will cradle the infant's head with one hand, using the other hand to gently support the infant's lower body and legs in a flexed position. The touches will be administered for 1 minute at the start of the essential care episode, 30 seconds after the diaper change, and 1 minute at the conclusion of the care episode.
15729267|NCT05030194|Other|Electronic Cigarette|Participants engage in 30 minutes of an oral nicotine product. In those 30 minutes the product can be used as much or as little as preferred.
15729268|NCT05030194|Other|Oral Nicotine Pouch|Participants will be instructed to place a 6mg nicotine pouch in their mouth between gum and lip for up to 30 minutes.
15729269|NCT05030181|Other|kinesiotaping and exercise|kinesiotaping group, ''I'' strip kinesiotape will be applied with the space correction technique for the upper trapezius muscle, for a total of 4 sessions, 2 days a week, and the patients will be included in the 1-month home exercise program.
15729270|NCT05030181|Other|exercise|exercise
15729271|NCT05030168|Drug|Ketosteril|ketoanalogues of essential amino acid
15729272|NCT05030155|Drug|Mepolizumab|300 mg/month subcutaneous
15729273|NCT05030155|Drug|cyclophosphamide/azathioprine|Patients with FFS≥1 will receive cyclophosphamide then azathioprine
15729274|NCT05030155|Drug|Placebo|Patients with FFS=0 will receive placebo
15729275|NCT05030142|Procedure|Mechanical Thrombectomy|Mechanical thrombectomy (using a stent retriever among the following:Trevo NXT ProVue Retriever, Catchview mini, pReset Lite, Tigertriever 13) in association with the best medical treatment (usual care)
15729276|NCT05030142|Drug|Best medical treatment alone|Best medical treatment alone (usual care)
15729277|NCT05030129|Dietary Supplement|5-Hydroxytryptophan / Vitamin B6|5-hydroxytryptophan, also known as 5-HTP has a nutraceutical status and has never been approved as a drug for any indication, but as a dietary supplement has been used extensively for several disorders for many years such as in the therapy of depression, fibromyalgia, obesity, insomnia and chronic headache
15729278|NCT05030129|Drug|Ergoloid Mesylate|Ergoloid Mesylates, trade name Hydergine, is a mixture of the methanesulfonate salts of three dihydrogenated ergot alkaloids, dihydroergocristine, dihydroergocornine, and alpha- and beta-dihydroergocryptine. Ergot alkaloids are dopamine agonists which activate dopamine receptors (in the basal ganglia and other parts of the brain involved in motor function) and a prolactin inhibitor. Ergot is a strong vasoconstrictor and thus helps to reduce bleeding by narrowing of the blood vessels.
15729279|NCT05030129|Other|Placebo|Placebo capsules
15729280|NCT05030116|Drug|Shenqu Xiaoshi oral liquid|Shenqu Xiaoshi oral liquid
15729281|NCT05030116|Drug|Domperidone suspension|Domperidone suspension
15729282|NCT05030103|Device|Reading glasses, +2.0 diopters|The participants in the glasses-group are asked to wear the reading glasses during near-work.
15729283|NCT05030090|Behavioral|Nutritional consultant|The control group is to be consulted by the dietitian using communication software (Line) or telephone to evaluate the nutritional requirement and guide the cancer diet principles before starting the project.
15729284|NCT05030090|Dietary Supplement|Nutritional consultant + High-calorie, high-protein liquid nutrition supplement|At the beginning of the plan, the dietitian first calculates the patient's daily calorie intake and the ratio of the three macronutrients and guides the patients or their family members of the nutritional care plan group A to implement a daily diet with a concentrated high-calorie and high-protein liquid supplement (Commercial formula contains 425 kcal and 19.1 grams of protein).
15729285|NCT05030090|Combination Product|Nutritional consultant + Liquid supplement + Powdered supplement 1 and 2|At the beginning of the plan, the dietitian first calculates the patient's daily calorie intake and the ratio of the three macronutrients and guides the patients or their family members of the nutritional care plan group B to implement a daily diet with a concentrated high-calorie and high-protein liquid supplement (Commercial formula contains 425 kcal and 19.1 grams of protein). Meanwhile, nutrition care plan group B will be given powdered supplement 1 (containing β-glucan and gamma-aminobutyric acid) and nutritional products and powdered supplement 2 (contains water-soluble dietary fiber and probiotics).
15729286|NCT05030077|Drug|Anlotinib|Anlotinib(12mg) oral daily for days 1-14, 21 days per cycle
15729290|NCT05030064|Drug|Intestinal flora capsule|"This research group has independently researched and created a human intestinal flora capsule based on intestinal bacteria transplantation: Intestinal flora capsule, which has been declared a national invention patent (patent number: 2015103040414)."
15729291|NCT05030064|Procedure|placebo capsule|Each placebo capsule is the two-layer empty capsule shell of the Intestinal flora capsule, which is made of titanium dioxide and iron oxide yellow. It is non-toxic and has the same appearance as the authentic Intestinal flora capsule.
15729292|NCT05030051|Device|SkinPen Precision System|Microneedling is a relatively new, minimally invasive technique originally developed for skin rejuvenation. Controlled micro-injury to the dermis via the application of several small needles connected to a motorized device stimulates the wound healing process, resulting in the formation of new tissue and blood vessels. The SkinPen by Crown Laboratories is an FDA-cleared microneedling device proven to improve the appearance of acne scars This study evaluates the clinical performance of the SkinPen device for the treatment of signs of aging on the back of the hand. We hypothesize that the SkinPen device will produce a significant improvement in dorsal hand appearance at 3 month post treatment visit, when compared with baseline scores. The assessments will be based on the Clinician's Global Aesthetic Improvement Scale, and the Subject's Global Aesthetic Improvement Scale at the 3 month post treatment visit.
15729295|NCT05030025|Drug|Experimental: Abacavir, Dolutegravir and Lamivudine Dispersible Tablets, 60mg/5mg/30mg|Bioavailability
15729296|NCT05030025|Drug|Active Comparator: Triumeq Dispersible Tablets (5mg GSK1349572 [dolutegravir]/60mg abacavir/30mg lamivudine) (ViiV)|Bioavailability
15729297|NCT05030012|Device|Automated Control|The purpose of this intervention is to evaluate that the efficacy and safety during the automated performance of the Vapotherm OAM are not inferior to standard care practice (manual control) in maintaining SpO2 levels of 90-95% in preterm infants requiring oxygen adjustments while being treated with high velocity nasal insufflation (HVNI) therapy.
15729298|NCT05030012|Device|Manual Control|The purpose of this intervention is to establish an active comparator via standard care practice against which to evaluate the efficacy and safety of the automated arm of the study, for determination of non-inferiority of that automated control arm to manual control in maintaining SpO2 levels of 90-95% in preterm infants being treated with high velocity nasal insufflation (HVNI) therapy.
15729299|NCT05029999|Drug|PLD Chemotherapy|PLD chemotherapy will be administered 40 mg/m2 as intravenous injection once per cycle.
15729300|NCT05029999|Drug|CDX-1140|CDX-1140 will be administered 1.5mg/kg as intravenous injection once per cycle.
15729301|NCT05029999|Drug|CDX-301|CDX-301 will be administered 75µg/kg as subcutaneous injection daily x 5 doses per cycle for 2 cycles.
15729302|NCT05029986|Behavioral|Socialization phase|Control condition: does not involve speech-related exercises
15729303|NCT05029986|Behavioral|Speech breathing intervention|Experimental condition: involves speech-related exercises
15729304|NCT05029973|Drug|HAIC|hepatic arterial infusion (HAI) of oxaliplatin, fluorouracil/leucovorin (FOLFOX) treatment
15729305|NCT05029973|Drug|Sintilimab|200mg IV d1,Q3W
15729306|NCT05029973|Drug|Bevacizumab Biosimilar|15mg/kg IV d1,Q3W
15729307|NCT05029960|Drug|Brivaracetam|Dose of 50 mg twice daily for 6 months
15729308|NCT05029947|Procedure|Microsurgical Clipping of Unruptured Intracranial Aneurysm|Microsurgical Clipping of Unruptured Intracranial Aneurysm
15729309|NCT05029934|Procedure|use of EndoClot|deployment of EndoClot adhesive spray
15729311|NCT05029908|Diagnostic Test|Jaw Functional Limitation Scale|DC/TMD Axis I TMD Pain Screener Questionnaire and TMD Symptom Questionnaire will be administered to the participants. To determine parafunctional habits and limitation of function, the DC/TMD Axis II assessment tools 'Jaw Functional Limitation Scale-8 (JFLS-8) and Oral Behavioral Checklist (OBC) will be applied. In addition, demographic data (age, gender, education level, occupation) will be questioned.
15729313|NCT05029869|Diagnostic Test|ctDNA|The blood samples for ctDNA and other tumor markers will be first collected within 14 days before surgery, and then be tested after gastrectomy in scheduled interval
15729314|NCT05029856|Biological|SII B.1.351|"Intramuscular (deltoid) injections of 3 μg SII B.1.351 and 50 μg Matrix-M1 Adjuvant,
~1 or 2 doses:1 on Day 0 and ± 1 on Day 21."
15729315|NCT05029856|Biological|SII B.1.351|"Intramuscular (deltoid) injections of 5 μg SII B.1.351 and 50 μg Matrix-M1 Adjuvant,
~1 or 2 doses:1 on Day 0 and ± 1 on Day 21."
15729316|NCT05029856|Biological|SII Bivalent|Intramuscular (deltoid) injections of 6 μg SII Bivalent and 50 μg Matrix-M1 Adjuvant, 2 doses: 1 on Day 0 and 1 on Day 21.
15729317|NCT05029856|Biological|SII Bivalent|Intramuscular (deltoid) injections of 10 μg SII Bivalent and 50 μg Matrix-M1 Adjuvant, 2 doses: 1 on Day 0 and 1 on Day 21.
15729318|NCT05029856|Biological|SII B.1.617.2|"Intramuscular (deltoid) injections of 5 μg SII B.1.617.2 and 50 μg Matrix-M1 Adjuvant,
~1 or 2 doses:1 on Day 0 and ± 1 on Day 21."
15729319|NCT05029830|Combination Product|investigations like MRI..|• Multiple Sclerosis Quality of Life-54 (MSQOL-54) Can be considered as the most known disease-specific instrument for the evaluation of quality of life in patients with multiple sclerosis (MS). It was developed to combine generic quality of life aspects of the SF-36 with MS-targeted dimensions and ratings for the overall quality of life. Therefore, 18 disease-specific items were added to the original 36 items of the SF-36. The 54 items are divided into 12 multi-item and 2 single-item scales. The MSQOL-54 items are transformed linearly to 0-100 scores and final scores are obtained by averaging items within the scales
15729320|NCT05029804|Other|Education|This intervention will be applied to the patients in the experimental group. The education will be provided by the researcher and based on the transtheoritical model. Printed materials and PowerPoint presentations will be used for the education and the education will be conducted in a face-to-face session with each participant (10 weeks).
15729321|NCT05029791|Other|Tumor biopsy|2 cutaneous tumor biopsies before treatment initiation (D-28 to D-1) and under treatment (Month 1)
15729322|NCT05029791|Other|Blood sample|1 EDTA blood sample (8mL) before treatment initiation (D-28 to D-1)
15729323|NCT05029778|Dietary Supplement|L-arginine 3g + L-Citruline 2 g|receive L-arginine 3g + l-Citruline 2 g PO, for 24 h, until birth.
15729324|NCT05029778|Drug|Placebo|receive placebo 3g PO, for 24 h, until birth.
15729325|NCT05029765|Dietary Supplement|Mediterranean diet|"Mediterranean diet:
~22% Monounsaturated fat, 6% Polyunsaturated fat, 7% Saturated fat, 15% Protein, 50% Carbohydrates"
15729326|NCT05029765|Dietary Supplement|Healthy diet (WHO recommendations)|Recommendations according to WHO
15729327|NCT05029765|Dietary Supplement|Placebo|Placebo
15729328|NCT05029765|Dietary Supplement|Biopolis-MIX42|Biopolis-MIX42: a capsule containing 10^9 colony forming units of Lactobacillus rhamnosus and Bifidobacterium longum.
15729329|NCT05029752|Device|Vendys II Device|Using the device
15729330|NCT05029739|Device|A PAD-specific smartphone application (e-intervention) developed for patients with Peripheral Artery Disease|See description of the e-intervention group as above.
15729331|NCT05029726|Drug|Bupivacaine-Epinephrine 0.25%-1:200,000 Injectable Solution plus clonidine|Bupivacaine-Epinephrine 0.25%-1:200,000 plus clonidine 50 micrograms in 30cc syringes administered as ESPB
15729332|NCT05029726|Drug|normal saline|normal saline in 30cc syringes administered using ESPB technique
15729333|NCT05029713|Diagnostic Test|Evaluation of appendicular skeletal muscle mass (ASMM) by bioelectrical impedance analysis (BIA)|The use of handgrip dynamometer and BIA will be used to screen all liver transplanted patients for sarcopenic obesity, using a muscle strength cut-off <27 Kg in men and <16 Kg in women and a standardized muscle mass cut-off <0.789 ASMM/BMI for men and 0.512 ASMM/BMI for women.
15729334|NCT05029700|Other|Combined exercise training|Combined exercise group (CEG) performed 30 minutes of aerobic training and also received trunk stabilization training in about 30 minutes after a 10-minute resting period. CEG received treatment 2 times a week for 8 weeks. During trunk stabilization training, the participants were taught how to contract the transversus abdominis and multifidus muscles. Due to the progression protocol, endurance levels of trunk muscles were increased by holding each posture for longer periods. The training was started with theraband resistance, which could be repeated between 10-12 repetitions, and the repetition time was increased up to 20. Aerobic training (AT) was given using a treadmill. A heart rate monitor (Polar V800™, Finland) was used by each patient to follow heart rates during the AT. During AT, the target heart rate was calculated as 60-80% of maximum heart rates (MHR). Each exercise session consisted of a 5-minutes warm-up, 20 minutes of walking, and 5 minutes cool down on the treadmill.
15729335|NCT05029700|Other|Aerobic training|Control group (CG) performed 30 minutes of aerobic training.CG received treatment 2 times a week for 8 weeks. Aerobic training (AT) was given using a treadmill. A heart rate monitor (Polar V800™, Finland) was used by each patient to follow their heart rates during the AT. During AT, the target heart rate was calculated as 60-80% of maximum heart rates (MHR). Each exercise session consisted of a 5-minutes warm-up, 20 minutes of walking, and 5 minutes cool down on the treadmill.
15729338|NCT05029674|Device|Whoop|Wear WHOOP Strap, complete surveys
15729339|NCT05029661|Diagnostic Test|Carotid ultrasound|"Ultra-COMPASS measurements (longitudinal + cross-sectional) Shear wave elastography: plaque stiffness Strain elastrogaphy: plaque deformation B-mode visualization: geometry
~Intima-media thickness
~Pulse wave velocity"
15729340|NCT05029648|Other|Cohort|Cohort
15729341|NCT05029635|Drug|HMPL-523|HMPL-523 will be oral administrated once daily for 24 weeks
15729342|NCT05029635|Drug|Placebo|HMPL-523 matching placebo will be oral administrated once daily for 24 weeks .
15729343|NCT05029622|Drug|Triptorelin Pamoate|Triptorelin 6-month formulation for IM on day 1 and Month 6.
15729344|NCT05029609|Drug|Intranasal Foralumab Solution|The Aptar Unidose device will be used to deliver foralumab nasal solution intranasally. Foralumab nasal solution is prepackaged in a Type 1 glass vial inside the Unidose device.
15729345|NCT05029609|Drug|Placebo|The placebo nasal solution is the acetate buffer vehicle used for foralumab nasal solution. It will be handled in a manner identical to active drug.
15729346|NCT05029596|Drug|Normal Saline Group|A 10cc NS flush will be administered intravenously through the peripherally inserted central line catheter after administration of medication, blood products, and blood draws. In addition the peripherally inserted central line catheter will be flushed intravenously with 10cc Normal Saline every 24 hours.
15729347|NCT05029596|Drug|Heparin Group|All lumens of PICC line will be flushed w/ Heparin Flush every 8 hours. PICC line will be flushed with 10cc Normal Saline followed by 3cc Heparin Flush after administration of medication, blood products, or blood draws.
15729348|NCT05029583|Other|routine screening|routine screening for advanced NASH
15729349|NCT05029583|Other|physician-driven screening|physician-driven screening for advanced NASH
15729350|NCT05029570|Device|Conduction System Pacing (pacemaker implantation)|Conduction System Pacing (pacemaker implantation) and Atrioventricular node ablation
15729351|NCT05029557|Behavioral|Education and telephone follow ups based on the Chronic Care Model|The effects of Chronic Care Model-based education and telephone follow-up given to patients with COPD on self-efficacy and patient-reported outcomes.
15729352|NCT05029544|Other|Dynamic taping|The intervention of this experimental study was therapeutic taping (dynamic tape) on the symptomatic shoulders of the participants.
15729353|NCT05029544|Other|Kinesio taping|The intervention of this experimental study was therapeutic taping (kinesio tape) on the symptomatic shoulders of the participants.
15729354|NCT05029544|Other|Physiotherapy and Rehabilitation|exercise, manuel therapy, mobilization, massage, sensorimotor control
15729355|NCT05029531|Combination Product|the risk-adapted choice of therapy and the use of a combination of chemotherapy with immunotherapy and hematopoietic stem cell transplantation for patients with risk factors.|two-stage stratification into risk groups: Initially and According to the results of induction therapy MRD-positive patients receive a course of blinatumomab and HSCT.
15729356|NCT05029518|Drug|SMP-100|In each period, subjects will receive a single dose of SMP-100 on Day 1 (Period 1), Day 4 (Period 2), and Day 7 (Period 3), under fasting or fed conditions, followed by 48 hours of PK and safety assessments.
15729357|NCT05029492|Other|Low-calorie diet|Low-calorie diet of 1200 kcal for 3 months, modified every two weeks.
15729358|NCT05029492|Other|Visceral manipulation with diet|Visceral manipulation to the pelvic organs and their related structures (8 sessions, once per week in the first month then once every other week for two months) added to the same low-calorie diet as the group (A).
15729359|NCT05029479|Other|Bonding in NCCLs|bonding agent which can resist moisture and has shorter decalcifying and curing time
15729361|NCT05029453|Drug|Apatinib|In experimental group, the drug used with apatinib and chemotherapy.
15729362|NCT05029440|Other|Pulsed Electromagnetic Field|PEMF was administered to the whole body for PEMF groups using a 1.8×0.6m mat 30 minutes/day, 3 times/week for 3 months.
15729363|NCT05029440|Other|Exercise Program|The exercise training program included treadmill and aerobic exercises for hip and upper limb and performed for 50 minutes.
15729364|NCT05029440|Other|Pulsed High Laser Therapy|High Laser was delivered with a total dose of energy of 3000 J was delivered in two treatment phases. The initial phase was performed with fast manual scanning at 510, 610, and 710 mJ/cm2 in three successive subphases and 500 J in each subphase for a total of 1500 J. The final phase was the same as the initial phase except that the scanning was slow. The average area for the upper thigh or lower back was 200 cm2 with an average fluency of 15 J/cm2 and the application time for each area was 18 min. HILT was applied using a HIRO 3 device (ASA, Arcugnano, Vicenza, Italy).
15729368|NCT05029401|Drug|DMX-1002|Investigation of the safety, tolerability and pharmacokinetics (PK) in healthy volunteers (Stage 1 - open-label), and the efficacy, safety, tolerability and PK in opioid-dependent patients (Stage 2 - blinded)
15729369|NCT05029401|Drug|Placebo|Matching placebo to the IMP (DMX-1002) for Stage 2 (phase 2 a) only
15729370|NCT05029388|Other|Aerobic Exercise|The participants will complete three training sessions per week over 10 weeks. The aerobic training program will last for one hour. The session will include a 10-minute warm-up period, followed by a 45-minute aerobic workout, wherein the participants can choose to use either a treadmill, a cycle ergometer, or a rowing ergometer. After the workout, a five-minute period of stretching will be provided for cooling down. The intensity during the workout will be set at 40%-55% of the individual's maximum heart rate.
15729371|NCT05029388|Other|High Intensity Interval Training|The intervention will be conducted over a period of 10 weeks, while the participants will complete three training sessions per week. The HIIT training program will last for 30 minutes. The session will include a 10-minute warm-up period, followed by a 15-minute HIIT workout, and a 5-minute period of stretching to cool down. The exercises will include repeated, high-intensity intermittent bursts of vigorous activity at maximal effort. The HIIT will mainly include bodyweight exercises (e.g., push-ups, squats, lunges) that disregards equipment usage. The intensity during the workout will be set to 85%-95% of the individual's maximum heart rate. A half-day training workshop will be provided to the personal trainer to ensure that he/she knows the exercises and can demonstrate them to the participants.
15729372|NCT05029375|Behavioral|PEERS® for Preschoolers|P4P is a 16-week manualized social skills treatment program, adapted from an existing empirically supported social skills intervention for young children with autism
15729373|NCT05029362|Behavioral|SmokefreeSGM|Participants will have access to a text-based smoking cessation program tailored to sexual minority individuals (SmokefreeSGM). The text-based program will be beta-tested by these participants for a period of 2 weeks before and 10 weeks after their quit date. Messages originated from the text-based smoking cessation program will be sent by a fictitious quit coach who will offer evidence-based advice on quitting smoking based on real-life experiences of sexual minority individuals.
15729374|NCT05029349|Device|VOC analysis|VOC analysis in exhaled air with e-noses and mass spectrometry.
15729375|NCT05029336|Biological|Depletion of CD3/CD19 in an autologous stem cell transplant|The purpose of this study is to determine the safety and feasibility of CD3/CD19 depleted autologous stem cell transplant for the treatment of life threatening autoimmune disease. We will perform CD3/CD19 depletion using the CliniMACs device as a means of purging autoreactive T and B cells from the transfused autologous stem cell product, while retaining some immune function, namely natural killer cells and monocytes in the product.
15729376|NCT05029323|Diagnostic Test|Fast HUTT|Fast HUTT protocol stabilization phase of 5 min in the supine position; passive phase of 10 min at a tilt angle of 60 degrees; provocation phase of further 10 min after 300 micrograms NTG sublingual spray.
15729477|NCT05028504|Drug|Anlotinib|A multi-target receptor tyrosine kinase inhibitor
15729377|NCT05029323|Diagnostic Test|Conventional HUTT|Conventional HUTT protocol stabilization phase of 5 min in the supine position; passive phase of 20 min at a tilt angle of 60 degrees; provocation phase of further 15 min after 300 micrograms NTG sublingual spray.
15729378|NCT05029310|Drug|Patiromer Oral Product|interaction study
15729379|NCT05029297|Drug|Capsaicin|
15729380|NCT05029284|Behavioral|teleABLE|Participants will be guided to self-monitor their daily activities, schedule personally meaningful non-sedentary activities, collaboratively problem solve to overcome barriers to the activity, and self-assess their progress. Participants may be asked to self-monitor their activity levels and complete planned activities between sessions.
15729381|NCT05029271|Device|InPen with Guardian 4 System|Subjects will receive the InPen™ and InPen™ Diabetes Management App combined with the Guardian™ 4 system.
15729382|NCT05029258|Procedure|Biopsy of tumour|Cervical tumour biopsy during treatment. This will be used for gene expression (RNA) analysis against a hypoxia associated gene signature.
15729383|NCT05029258|Diagnostic Test|MRI scans|Multiple magnetic resonance imaging (MRI) scans before and during treatment using oxygen enhanced (OE) / tissues oxygen level dependent (TOLD) sequence
15729384|NCT05029245|Biological|Comirnaty®|intradermal injection or intramuscular injection
15729385|NCT05029232|Diagnostic Test|MLPA for duchenne|MLPA test for genetic testing to detect gene affection in DMD , and other tests for confirmation and follow up
15729386|NCT05029219|Device|Arm I (Virtual reality group)|"In the preparatory session, the participant is given a survey. It is about demographic information such as gender, age, and age, as well as prior experience with the procedure. The primary test is performed with a fluoroscopy guided lumbar transforaminal epidural block with a human-shaped phantom.
~After that, the test group and the control group receive the same audiovisual education for about 5 minutes. The test group receives about 60 minutes of training using a virtual reality program."
15729387|NCT05029219|Device|Arm II (Self study group)|"In the preparatory session, the participant is given a survey. It is about demographic information such as gender, age, and age, as well as prior experience with the procedure. The primary test is performed with a fluoroscopy guided lumbar transforaminal epidural block with a human-shaped phantom.
~After that, the test group and the control group receive the same audiovisual education for about 5 minutes. The control group have provided with video materials and books provided during audiovisual education and have given time for self-study for 60 minutes. Subsequently, a second test is performed with a fluroscopy-guided lumbar transforaminal epidural block with a human-shaped phantom."
15729388|NCT05029206|Procedure|Autologous hematopoietic stem cell transplantation|"The therapeutic intervention of AHSCT consists of four parts: the mobilization of hematopoietic stem cells (HSC), the harvest of HSC, the ablation (conditioning) of the immune system and the reinfusion of autologous HSCs.
~In Sweden, the mobilization of HSCs has been made by a combination of cyclophosphamide (2 g/m2) and granulocyte-colony-stimulating factor.
~A minimum of 2 × 10^6 CD34+ cells/kg is harvested and cryopreserved. No in vitro manipulation is done to the stem cells.
~Two conditioning regimens have been used in Sweden for ablation. The BEAM-ATG protocol include carmustine (BCNU) 300 mg/m2, etoposide 800 mg/m2, cytarabine arabinoside (ARA-C) 800 mg/m2 and melphalan 140 mg/m2 + rATG or hATG. The Cy-ATG protocol include cyclophosphamide 200 mg/kg + rATG/hATG with 1000 mg Metylprednisolone given day -5 to -1.
~After a minimum of 24 hours after the last administration of chemotherapy have passed, the reinfusion of autologous CD34+ cells is performed."
15729389|NCT05029193|Behavioral|Langerian mindfulness|A 3-week Langerian mindfulness intervention will be offered entirely online. The purpose of the intervention is: 1) to increase participants' mindfulness, and 2) to encourage participants to change their beliefs about the disability associated with stroke to improve their psychological state. Mindfulness refers to the act of being aware: aware of thoughts, aware of emotions, aware of physical sensations, aware of others. The intervention consists of educational texts, daily exercises, audio recordings and videos. Five different topics related to mindfulness will be introduced throughout the intervention.
15729390|NCT05029180|Other|Termination of resuscitation|Do estimate the approaches used worldwide when terminating resuscitative efforts
15729391|NCT05029167|Other|Restrictive PaO2|Patients are randomized to a PaO2 target of 9-10 kPa (open-label).
15729392|NCT05029167|Other|Low normal MAP|The patients are randomized to receive a Phillips M1006B blood pressure measuring module, offset by +10 %. All patients will target a MAP of 70, but due to the offset module, the patients will target an actual blood pressure of 63 mmHg.
15729393|NCT05029167|Other|Liberal PaO2|Patients are randomized to a PaO2 target of 13-14 kPa (open-label).
15729394|NCT05029167|Other|High normal MAP|The patients are randomized to receive a Phillips M1006B blood pressure measuring module, offset by -10 %. All patients will target a MAP of 70, but due to the offset module, the patients will target an actual blood pressure of 77mmHg.
15729395|NCT05029154|Behavioral|High intensity interval exercise|Patients in the exercise group will perform interval training (HIIT) 3 days per week, with each session consisting of four, 4-min intervals at 85-90% peak heart rate (PHR), separated by 3 min at 50% PHR. Each training session will begin with a 10-minute warm-up at 50% of PHR and end with a 5-min cool down at 50% PHR. Patients will undergo 2 initial training sessions at the exercise physiology core lab. All exercise will consist of stationary cycling to avoid discomfort associated with abdominal surgery as well as stress to the incision and help reduce fall risk. Study investigators will check in weekly with participants and remotely track exercise data and compliance via the Fitbit app.
15729396|NCT05029154|Behavioral|Attention control|Patients in the control group (physical activity education and physical activity monitoring) will receive counseling regarding the benefits of physical activity during chemotherapy treatment. During the intervention, participants will receive a weekly phone call to discuss their physical activity and remind them to engage in physical activity. Patients will be given a goal of working up to 30 minutes of exercise daily. Subjects will be urged to increase daily step counts by 250-500 steps/day. Physical activity will be objectively assessed and made available to the participant using a Fitbit.
15729436|NCT05028803|Drug|sodium phenylbutyrate|same as arm/group
15729397|NCT05029141|Drug|CAHAG regimen|"Chidamide 30mg orally twice every week for 2 weeks on days 1, 4, 8, 11, azacytidine 75mg/m2 intravenously daily for 7 days (d3-d9) and HAG regimen (cytarabine, 10 mg/m2 subcutaneously every 12 h on days 3-16; homoharringtonine, 1mg/m2 intravenously every day on days 3-16; and concurrent granulocyte colony-stimulating factor, 200mg/m2/day subcutaneously daily from days 2 to neutral granulocyte recovery. (when WBC > 20×10E9/L, G-CSF paused).
~One treatment cycle for 28 days, a total of 2 cycles. If the bone marrow assessment is MLFS on the 28th day in the first cycle, the second cycle of treatment will be started after NE<1.0×10E9/L; if the delay exceeds 2 weeks, the patient needs to withdraw from the trial."
15729398|NCT05029141|Drug|Placebo regimen|"Chidamide 0mg orally twice every week for 2 weeks on days 1, 4, 8, 11, azacytidine 75mg/m2 intravenously daily for 7 days (d3-d9) and HAG regimen (cytarabine, 10 mg/m2 subcutaneously every 12 h on days 3-16; homoharringtonine, 1mg/m2 intravenously every day on days 3-16; and concurrent granulocyte colony-stimulating factor, 200mg/m2/day subcutaneously daily from days 2 to neutral granulocyte recovery. (when WBC > 20×10E9/L, G-CSF paused).
~One treatment cycle for 28 days, a total of 2 cycles. If the bone marrow assessment is MLFS on the 28th day in the first cycle, the second cycle of treatment will be started after NE<1.0×10E9/L; if the delay exceeds 2 weeks, the patient needs to withdraw from the trial."
15729399|NCT05029128|Behavioral|Endurance exercise intervention|All participants engage in treadmill walking 4 days/week, 60 minutes/day, at 70-80% of HRmax for 4 weeks.
15729400|NCT05029115|Drug|SGLT2 inhibitor|Dapagliflozin, Empagliflozin
15729401|NCT05029102|Drug|TAS 102|35 mg/m2，per oral，twice daily, days 1-5 and 8-12 of each 28-day cycle
15729402|NCT05029102|Drug|Anlotinib|10mg，per oral，once daily，days 1-14 of each 21-day cycle
15729403|NCT05029089|Procedure|Modified Entire Papilla Preservation Technique (MEPPT) For Periodontal Regenerative Treatment Of Intrabony Defects.|Surgical approach using modified papilla preservation technique for regenerative periodontal therapy.
15729404|NCT05029089|Device|Emdogain (EMD), Biomaterials (allograft, subepithelial connective tissue graft/sCTG)|Surgical approach using modified papilla preservation technique and devices for regenerative periodontal therapy.
15729405|NCT05029089|Procedure|Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain For Periodontal Regenerative Treatment Of Intrabony Defect|Surgical approach using modified papilla preservation technique and Emdogain for regenerative periodontal therapy.
15729406|NCT05029089|Procedure|Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain and Allograft For Periodontal Regenerative Treatment Of Intrabony Defect|Surgical approach using modified papilla preservation technique and Emdogain and Allograft for regenerative periodontal therapy.
15729407|NCT05029089|Procedure|Modified Entire Papilla Preservation Technique (MEPPT) with Emdogain and Allograft and sCTG For Periodontal Regenerative Treatment Of Intrabony Defect|Surgical approach using modified papilla preservation technique and Emdogain and Allograft and sCTG for regenerative periodontal therapy.
15729408|NCT05029076|Drug|Liraglutide injection|Human glucagon-like peptides-1 analogue
15729409|NCT05029076|Drug|Victoza|Human glucagon-like peptides-1 analogue
15729410|NCT05029063|Drug|Rivaroxaban 10 MG|Identical comparator drug
15729411|NCT05029050|Drug|Dexmedetomidine|Continous intravenous infusion
15729412|NCT05029050|Drug|Clonidine|Continous intravenous infusion
15729413|NCT05029050|Drug|Natriumchlorid|Continous intravenous infusion NaCl
15729414|NCT05029037|Drug|High doses of intravenous vitamin C|Two (2) High doses of intravenous vitamin C for seven (7) days.
15729415|NCT05029037|Drug|Dextrose 500 mL|"Application of a vial of LEV in 100 mL of water for injection, which is diluted in 400mL of 5% Dextrose for a final volume of 500mL of intravenous fluids, to be applied to the chosen patient, in a drip of 0.5 grams of the placebo solution per minute, for a total of 60 minutes.
~Twice a day for seven days."
15729416|NCT05029024|Other|30-minute mindful breathing|The four exercises included identifying the in-and out-breath, following the entire length of the breath, bringing the mind back to the body and relaxing the whole body. Each exercise lasted 7.5 minutes.
15729417|NCT05029024|Other|control group|standard care alone
15729418|NCT05029011|Device|MediByte VTS|The MediByte VTS is a portable device that continuously monitors vital signs. Participants in the study will wear the MediByte VTS for 24 hours.
15729419|NCT05028972|Other|Personal Amplifier|The intervention group will receive personal amplifiers (PockeTalkers) while they receive care in the ED
15729420|NCT05028972|Other|No Personal Amplifier|The control group will not receive personal amplifiers while they receive care in the ED
15729421|NCT05028959|Other|Multidisciplinary monitoring of healthy women|Multidisciplinary monitoring
15729422|NCT05028946|Drug|Foralumab|Foralumab will be administered per dose and schedule specified in the arm description.
15729423|NCT05028933|Drug|EPCAM CAR-T|Pretreatment with fludarabine and cyclophosphamide EpCAM CAR-T Cells infusion
15729424|NCT05028907|Drug|5 mg chloramphenicol, 1 mg dexamethasone sodium phosphate, 0.25 mg tetryzoline hydrochloride, 2 mg Hydroxypropyl Methyl Cellulose, 10 mg α-tocopherol acetate and 8 mg macrogol 400).|The patients were advised to apply the drops 5 times daily for the first week, three times daily for the next two weeks and one time daily for another one week. The patients were examined before treatment, one week, one month and three months later.
15729425|NCT05028907|Drug|sodium hyaluronate, polyethylene and propylene glycol based) three times daily for three months|The patients were advised to apply the drops 5 times daily for the first week, three times daily for the next two weeks and one time daily for another one week. The patients were examined before treatment, one week, one month and three months later.
15729426|NCT05028894|Other|No intervention|No intervention
15729427|NCT05028881|Other|blood sampling|blood sampling for determining antibody responses
15729428|NCT05028855|Diagnostic Test|Cerebral autoregulation assessment|Cerebral autoregulation assessment will be conducted by specialized neurovascular ultrasound doctors during 0-3 and 10-30 days after stroke onset.The recorded data will be stored for further cerebral autoregulation analysis.
15729429|NCT05028842|Other|No intervention|None.This is an observational study
15729430|NCT05028829|Drug|Atorvastatin 20mg|Oral administration of atorvastatin 20 mg
15729431|NCT05028829|Drug|Placebo|Oral administration of placebo
15729437|NCT05028790|Device|Single vision contact lens|Subjects will wear a single vision soft contact lens only during the study visit
15729438|NCT05028790|Device|Multifocal contact lens|Subjects will wear a multifocal soft contact lens only during the study visit
15729439|NCT05028764|Diagnostic Test|Buccal Swabs, Blood Draws and Skin Punch Biopsy|Buccal Swabs - FXN and specific RNA markers; Blood Draws - Lipid panel, Protein Marker Analysis and Gene RNA Analysis; Skin Punch Biopsy - Protein Markers
15729440|NCT05028751|Drug|Lanraplenib|Orally via tablets
15729441|NCT05028751|Drug|Gilteritinib|Orally via tablets
15729442|NCT05028738|Device|Repetitive Transcranial Magnetic Stimulation|rTMS will employ the MagPro X100 stimulator equipped with the cool-B70 coil (MagVenture, Farum, Denmark). The dose will be a 120% resting motor threshold (rMT) in accordance to our latest trial using iTBS. Localization of the right and left DLPFC will follow the well-established Beam F3 procedure. Subjects will then undergo 30 sessions of rTMS, once daily on weekdays for 6 weeks. FDA-approved iTBS protocol will consist of bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz for 600 pulses total, 2 s on, 8 s off, for 3 min 9 sec, at 120% rMT. LFR will consist of 1 Hz stimulation consisting of a single train of 10min duration for 600 pulses total at 120% rMT.
15729443|NCT05028725|Device|EsophaCap Sponge|Non-invasive strategy to sample esophageal tissue
15729444|NCT05028725|Procedure|Chromoendoscopy|Lugol's iodine chromoendoscopy is a technique that is used to identify mucosal abnormalities of the esophagus
15729445|NCT05028725|Device|EsoCAN assay|Biomarker Test
15729446|NCT05028712|Behavioral|Visual Information Training|Participants in this arm will receive training to improve the use of residual vision to enhance functional performance.
15729447|NCT05028712|Behavioral|Multimodal training|Participants in this arm will receive training in integrating input from different senses to enhance functional performance.
15729448|NCT05028699|Other|Snack|Participants will consume 32 g of a common bean baked snack per day for 28 days during the intervention stage.
15729449|NCT05028686|Other|No intervention|Observational cohort
15729450|NCT05028673|Drug|Lu AG06466 Capsule|Hard capsule
15729451|NCT05028673|Drug|Lu AG06466 Tablet|Film-coated tablet
15729452|NCT05028673|Drug|Antacid|Oral suspension
15729453|NCT05028660|Diagnostic Test|GAG score|blood and urine samples to determine GAG scores
15729454|NCT05028647|Device|Virtual reality training|one hour a day for 5 days of engagement in tasks proposed by a specially crafted software through a VR device (Oculos)
15729455|NCT05028647|Device|Augmented reality training|one hour a day for 5 days of engagement in tasks proposed by a specially crafted software through a AR device (tablet)
15729456|NCT05028634|Biological|Tetanus, diphtheria, and acellular pertussis vaccine|Tdap
15729457|NCT05028634|Biological|Pneumococcal polysaccharide vaccine|PPSV23
15729458|NCT05028634|Biological|Seasonal influenza vaccine|Seasonal influenza vaccine
15729459|NCT05028621|Diagnostic Test|Genetic testing|Genetic testing of blood or tissue sample and limited medical information sent to an outside company. Database will link genome sequence data with human trait information, including cancer and other diseases, to be sent to participant's physician.
15729460|NCT05028608|Drug|Elinzanetant (BAY3427080)|Elinzanetant given orally as a single dose in Period 1 and in Period 2.
15729461|NCT05028608|Drug|Midazolam|Midazolam given orally as single dose in Period 1 and in Period 2.
15729462|NCT05028608|Drug|Carbamazepine|Carbamazepine given orally twice daily in Period 2 .
15729463|NCT05028582|Drug|ARQ-154 Foam 0.3%|ARQ-154 Foam 0.3%
15729464|NCT05028582|Drug|ARQ-154 Vehicle|Vehicle
15729467|NCT05028556|Drug|Chort 1 of Y101D|Y101D, 1mg/kg, Q2W, intravenous infusion
15729468|NCT05028556|Drug|Chort 2 of Y101D|Y101D, 3mg/kg, Q2W, intravenous infusion
15729469|NCT05028556|Drug|Chort 3 of Y101D|Y101D, 10mg/kg, Q2W, intravenous infusion
15729470|NCT05028556|Drug|Chort 4 of Y101D|Y101D, 20mg/kg, Q2W, intravenous infusion
15729471|NCT05028556|Drug|Chort 5 of Y101D|Y101D, 30mg/kg, Q2W, intravenous infusion
15729472|NCT05028543|Procedure|Conventional TLH|"Procedure: conventional Total laparoscopic hysterectomy the uterine artery will be identified close to the isthmus then coagulated at this level, close to the uterus , using bipolar diathermy. The utero-vesical fold will be dissected and the bladder will be pushed down done.. The vasculature of the uterus will now secured and this will be evidenced by the pale color of the fundus.
~Using either bipolar diathermy , the cornual pedicles on one side will be desiccated and cut. Also, both the uterosacral and cardinal ligaments will be coagulated and cut. So that, the opposite side pedicles can be taken care of.. The infundibulopelvic ligaments will be coagulatd and cut if it is necessary to remove both ovaries. A vaginal cuff was inserted into the vagina to identify the vault, which will then cut laparoscopically using a monopolar hook, where the specimen will be completely detached."
15729473|NCT05028543|Procedure|Clipping of utrine artery at its origin before bginning of TLH|"the uterine artery will be dissected using posteriorly and medially to the infundibulopelvic ligament, the ureter should be first identified. The surgeon may grab the obliterated umbilical artery at the anterior abdominal wall and retract it. The movement of the umbilical artery may be Seen at the ovarian fossa perpendicular to the ureter
~The uterine vessels will be clipped at their origin from the hypogastric vessels using aclip applier which will be introduced through 10mm trocar. clipping of the artery will be performed through application of two 5 mm size metallic clips in continuity and complete the laparoscopic hysterectomy with the same steps of the conventional method."
15729474|NCT05028517|Other|FMF Connect|The FMF Connect intervention includes cloud infrastructure and an innovative, multilayered mobile app. It incorporates tailored content for parents/caregivers of children (ages 3-12) with FASD or PAE. The app integrates five main components: 1) Dashboard; 2) Learning Modules; 3) Family Forum; 4) Library; and 5) Notebook. Weekly emails are also sent to support motivational engagement.
15729475|NCT05028517|Other|Coaching|A text-based coaching module is added to the FMF Connect app. Coaches support continued use of the app and individualized goal setting.
15729476|NCT05028504|Drug|Penpulimab|Penpulimab is a humanized monoclonal antibody targeting programmed cell death-1 (PD-1), which prevents PD-1 from binding to PD-L1 and PD-L2 receptors on tumor cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
15729478|NCT05028478|Drug|CN202|Participants will receive CN202 by IV infusion on Day 1 of each cycle (once every 2 weeks). The 4 planned dose levels are 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg
15729479|NCT05028465|Procedure|Endoscopic Papillectomy|A snare devicewas inserted via the working channel, and the endoscopist adjusted the snare to securely grasp the lesion, which was then excised by using standard electrocautery.
15729480|NCT05028465|Procedure|Endobiliary Radiofrequency Ablation|The RFA catheter was then placed under fluoroscopic guidance across the distal common bile duct. An ERBE VIO200D generator (ERBE Elktromedizin, Tubingen, Germany) was connected for RFA at 10 W for 90 seconds.
15729481|NCT05028452|Other|Internet based support|Carer eSupport is designed to prepare informal caregivers for caregiving, to decrease caregiver burden and prevent a deteriorated health.
15729482|NCT05028439|Device|radiofrequency ablation|All patients underwent biliary sphincterotomy. Cholangiogram was performed to confirm stricture location, length and diameter. The Habib Endo HPB (Hepatobiliary) probe (EMcision, HitchinHerts, UK) was then advanced over a wire at the level of the biliary stricture and ablation using ERBE generator set at 7-10 watts for a time period of 90-120 s was conducted. A 1- to 2-min resting period after energy delivery was allowed before moving the catheter along the length of the stricture to ablate the rest of the stricture. Plastic stent(s) were placed after RFA depending on the location of the malignant obstruction
15729483|NCT05028439|Drug|Chemotherapy drug|Gemcitabine 1 000 mg/m2 intravenously on day 1，8; S-1 80 mg/m2 was taken orally twice for two weeks. The curative effect was evaluated comprehensively for each 2 cycles of chemotherapy
15729484|NCT05028426|Procedure|Enhanced recovery program|Enhanced recovery programs are a multimodal approach to optimize patients' physiological and psychological states in the preoperative, intraoperative and postoperative care domains.
15729485|NCT05028413|Behavioral|Participants Shown their Breath Alcohol Content Measurement|Each time a Breath Alcohol Content (BrAC) Measurement is taken by the research team, the participant is shown the measurement before completing the paper visual analog scale scale (the Self-Reported intoxication Survey) on their perceived fitness to drive.
15729486|NCT05028400|Device|Laser speckle contrast imaging (LSCI)|LSCI videos will be recorded automatically intraoperatively in each patient before, during, and after ICGA and/or FA in the same surgical field of view to guarantee comparability of the methods.
15729487|NCT05028387|Drug|medical abortion|medical abortion
15729488|NCT05028374|Drug|"A single booster dose of the Moderna mRNA COVID-19 vaccine"|All participants will receive a single dose of the Moderna mRNA COVID-19 vaccine administered intramuscularly. This is an open label, non-randomized trial.
15729490|NCT05028348|Drug|Selinexor|Selinexor will be given as an oral dose 60 mg (3 20 mg tablets) QW on Days 1, 8, 15, and 22 of each 28-day cycle.
15729491|NCT05028348|Drug|Elotuzumab|Elotuzumab will be given IV 10 mg/kg on Days 1, 8, 15, and 22 of cycle 1 and 2 then 20 mg/kg on Day 1 of cycles ≥3 of each 28-day cycle.
15729492|NCT05028348|Drug|Pomalidomide|Pomalidomide will be given as an oral 4 mg dose QD on Days 1 to 21 of each 28-day cycle.
15729493|NCT05028348|Drug|Dexamethasone Oral|Dexamethasone will be given as an oral 40 mg dose QW on Days 1, 8, 15, and 22 of each 28-day cycle. Preferred dosing of dexamethasone is 40 mg QW for patients who are ≤75 years of age (20 mg QW for >75-year-old patients at the Investigator's discretion) before QW dosing of selinexor, however, it may be divided over 2 days at the Investigator's discretion.
15729494|NCT05028335|Other|Carbamide Peroxide (PC) 22%) + placebo gel|Application of one drop of Polanight bleaching agent (SDI, SP, Brazil) on each corresponding tooth in a tray that was used for 45 minutes a day, for a period of twenty-one days. After the bleaching treatment, the participants were instructed to wash the trays under running water and dry them. The volunteers were instructed to apply a small amount of placebo gel, without active ingredient, with color, texture and odor similar to 1.5% oxalate gel (Painless, BM4, SC, Brazil) in the spaces related to the vestibular portions of the teeth trays, which were used for 10 minutes.
15729495|NCT05028335|Other|Carbamide Peroxide (PC) 22%) + Potassium Oxalate gel 1.5%|Application of one drop of Polanight bleaching agent (SDI, SP, Brazil) on each corresponding tooth in a tray that was used for 45 minutes a day, for a period of twenty-one days. After the bleaching treatment, the participants were instructed to wash the trays under running water and dry them with absorbent paper. The volunteers applied a small amount of 1.5% potassium oxalate gel (Painless, BM4, SC, Brazil) in the spaces relative to the vestibular portions of the tray's teeth, which were used for 10 minutes.
15729496|NCT05028322|Drug|IMIQUIMOD cream|Cream to apply before intra-dermal vaccine injection
15729497|NCT05028322|Biological|HEPATITIS B SURFACE ANTIGEN|HBV Vaccine
15729498|NCT05028296|Device|WATS Sampling|WATS sampling and analysis in the stomach compartments (antrium, incisira, corpus)
15729499|NCT05028283|Procedure|Fat Grafting|This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with atrophic acne scars on the cheeks
15729500|NCT05028270|Procedure|Balloon technology;Microcatheter technology|Describe each group's intervention in sufficient detail, including how and when to give the intervention Suspend or modify the criteria for interventions that have been assigned to the subject (such as changing the dose of the drug due to hazards or subject requirements or improvement/deterioration of the condition, etc.) Strategies to improve the compliance of intervention programs, and other measures to monitor compliance (such as the return of drug tablets, laboratory inspections, etc.) Related care and interventions allowed or prohibited during the trial
15729502|NCT05028244|Diagnostic Test|venous ultrasound of lower extremity|Patients inbed are explored for deep vein thrombosis in femoral-popliteal and distal veins of the legs with ultrasound compresión and doppler flow evaluation
15729503|NCT05028231|Procedure|Neoadjuvant Immunotherapy (PD-1 / PD-L1) Combined With Chemotherapy|Each patient will complete 2 cycles of neoadjuvant therapy. After evaluating the curative effect, decide whether to operate or not. Patients with and without surgery enter the survival follow-up period.
15729504|NCT05028218|Drug|TQB3824 tablets|TQB3824 is a CDC7 inhibitor, which plays important roles in the maintenance of DNA replication forks and DNA damage response pathways.
15729505|NCT05028205|Behavioral|Prevention Plus|Families will receive a behavioral intervention for childhood obesity provided by a BHC. This will consist of three, in-person meetings (months 1, 3, and 5), and three, 20-minute phone calls (months 2,4, and 6). During in-person visits, child height and weight will be taken, and BMI will be plotted on the BMI-for-age growth chart. During these sessions, families will receive feedback on child growth and weight status. Prevention Plus materials and child and caregiver energy balance behavior goals will be reviewed. The phone calls will be with the caregiver, where caregivers will be asked to measure the height and weight of their child, calculate BMI, and plot on the BMI-for-age growth chart. The BHC will discuss the family's progress on achieving child and caregiver goals and implementation of behavioral parenting strategies. Families will receive a fruit and vegetable prescription (FVx) in addition to the standard Prevention Plus family-based behavioral weight loss treatment.
15729506|NCT05028192|Other|no intervention|no intervention
15729507|NCT05028179|Diagnostic Test|EchoGo|EchoGo Pro is an software Medical Device which is able to assess Stress Echocardiograms and provide a binary classification of risk of CAD
15729508|NCT05028166|Drug|Mirdametinib (MEK Inhibitor)|Patients will receive oral mirdametinib.
15729509|NCT05028153|Drug|Azithromycin Oral Liquid Product|10 mg/kg for 3 consecutive days
15729510|NCT05028153|Other|Placebo mixture|Placebo mixture containing no active substance
15729511|NCT05028140|Drug|PIEMONTE|Piemonte association 1 coated tablet once a day
15729512|NCT05028140|Other|PIEMONTE PLACEBO|Placebo of Piemonte association 1 coated tablet once a day
15729513|NCT05028140|Drug|EMPAGLIFLOZIN|Empagliflozin 25 mg 1 coated tablet once a day
15729514|NCT05028140|Other|PLACEBO EMPAGLIFLOZIN|Placebo of empagliflozin 25 mg 1 coated tablet once a day
15729515|NCT05028140|Drug|PIOGLITAZONE|Pioglitazone 30 mg 1 tablet once a day
15729516|NCT05028140|Other|PLACEBO PIOGLITAZONE|Placebo of pioglitazone 30 mg 1 tablet once a day
15729517|NCT05028127|Drug|Bimekizumab|Subjects will be receiving bimekizumab at pre-specified time-points.
15729518|NCT05028114|Drug|AC-1202|Tricaprilin formulated as AC-1202
15729519|NCT05028114|Drug|AC-OLE-01|Tricaprilin Formulation
15729520|NCT05028114|Drug|AC-OLE-02|Tricaprilin Formulation
15729521|NCT05028114|Drug|AC-OLE-03|Tricaprilin Formulation
15729522|NCT05028114|Drug|AC-OLE-04|Tricaprilin Formulation
15729523|NCT05028114|Drug|AC-OLE-05|Tricaprilin Formulation
15729524|NCT05028114|Drug|AC-OLE-06|Tricaprilin Formulation
15729525|NCT05028114|Drug|AC-OLE-07|Tricaprilin Formulation
15729526|NCT05028114|Drug|AC-OLE-08|Tricaprilin Formulation
15729527|NCT05028114|Drug|AC-OLE-09|Tricaprilin Formulation
15729528|NCT05028114|Drug|AC-OLE-010|Tricaprilin Formulation
15729529|NCT05028114|Drug|AC-OLE-P|Placebo to tricaprilin formulation
15729530|NCT05028101|Procedure|Delayed autologous breast reconstruction|SOC: Delayed autologous breast reconstruction
15729531|NCT05028101|Behavioral|Perioperative Functional Medicine (FM) Care|SOC plus FM: A food plan that encourages consumption of nutrient-dense whole foods. It provides adequate protein, balanced quality fats and foods which contain targeted nutrients essential to proper wound healing. Select dietary supplements will be provided as an adjunct to the food plan. Health coaching will support optimal sleep, adequate movement/exercise and stress reduction.
15729532|NCT05028088|Drug|sugammadex|This study is a prospective, double-blind, low-intervention, non-randomized controlled clinical trial involving 99 patients with American Society of Anesthesiologists Ⅰ-Ⅲ, body mass index 18.5-24.9 kg/m2, who will undergo laparoscopic radical resection of liver cancer under general anesthesia in the Wuhan Union Hospital. Ultrasonography will be applied to monitor the change rate of diaphragm thickness at different time after extubation to evaluate the recovery rate of muscle relaxant, which indirectly reflects the dose-effect relationship of SUG antagonizing against rocuronium in patients with different liver Child-Pugh grades preoperatively.
15729533|NCT05028075|Behavioral|Cobalt +|Participants will complete baseline surveys at enrollment and then complete subsequent surveys (depression, anxiety, well-being, satisfaction with access to care, work productivity) at enrollment; 0 months and then again at 6 months. The primary endpoint is assessed at 6 months. A secondary endpoint of persistence of effect is measured 3 months later-9 months post initiation. The intervention group receives usual Cobalt plus: 1) monthly automated text messaging reminders and links to Cobalt resources 2) intermittent mental health assessments which triage individuals to an opt-out appointment based on their results. For the monthly automated text messaging reminders, we will assess how well these are delivered by assessing how often: links are clicked on, text messages receive a response, and participants request to stop receiving texts. For the opt out appointments, we will assess how often appointments are fulfilled or cancelled.
15729534|NCT05028062|Drug|XR-NTX 380 mg, intramuscular injection|Two doses of XR-NTX 380 mg, intramuscular injection.
15729535|NCT05028062|Behavioral|Medical Management|All subjects will receive 8 weeks of medical management (Pettinati et al. 2004) will support subjects' efforts to reduce or stop their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the subject's drinking, and make recommendations to follow until the next visit. Men will be advised to consume no more than 3 drinks 4 times per week; women will be advised to consume no more than 2 drinks 4 times per week.
15729536|NCT05028062|Drug|Placebo intramuscular injection|Two doses of XR-NTX 380 mg, intramuscular injection.
15729537|NCT05028049|Drug|Sufentanil injection|Sufentanil 0.3 μg/kg is intravenously administrated to maintain intraoperative analgesia
15729538|NCT05028049|Drug|Remifentanil Hydrochloride|Remifentanil 0.3ug/kg/min is intravenously administrated to maintain intraoperative analgesia
15729539|NCT05028049|Other|plain areas|Patients should be long staying residents in plain areas (altitude level below 1,000 meters above sea level)
15729540|NCT05028049|Other|plateau areas|Patients should be long staying residents in plateau areas (altitude level>3000 meters above sea level)
15729571|NCT05027867|Drug|KRT-232|Administered by mouth
15729572|NCT05027854|Other|TMS or tES|Transcranial magnetic or electric stimulation
15729573|NCT05027854|Other|sham TMS or tES|Sham transcranial magnetic or electric stimulation
15730095|NCT05023798|Device|ATD (device test)|Medical device test (no intervention)
15729541|NCT05028036|Other|Personalized lifestyle treatment program|"The personalized treatment program is based on the participants symptom profile and test results and is designed in collaboration with the participant. The treatment plan that may include several of the following components:
~Dietary changes
~Supplements
~Measures to improve sleep / circadian rhythm
~Stress management
~Physical exercise
~The treatment plan is evaluated continuously by the participant and the therapist and adjusted accordingly. A total of 9 visits to the Nordic Clinic over one year is included in the treatment program."
15729542|NCT05028023|Biological|Apneic oxygenation - supplemental high flow oxygen administration by an apneic way|In pediatric patients undergoing tracheal balloon dilatation, oxygenation maintenance is essential, while induction in anesthesia, cessation of spontaneous ventilation by neuromuscular relaxant and pediatric i-gel placement are necessary for access to trachea. After i-Gel placement controlled ventilation with 100% oxygen is initiated. Pediatric bronchoscope and balloon dilatation catheter are advanced into trachea to the stenotic area. Overall dilatation duration is 2,5-3minutes, while the balloon is inflated for 60sec. Every dilatation cession consists of three dilatations. First dilatation is performed without oxygen enrichment. During second and third dilatation, a nelaton catheter, connected with high oxygen flow, is advanced into i-Gel canal, together with bronchoscope and balloon catheter. Effects of no oxygenation and apneic oxygenation in regional cerebral oxygen saturation rSO2, pulse oximetry SpO2, arterial blood gases and haemodynamics are recorded and compared.
15729543|NCT05028010|Behavioral|Capacity building|Four days of training on the promotion of maternal and child nutrition will be given. The training will be based on Pender's health promotion model. Supportive supervision will be conducted.
15729544|NCT05027997|Drug|Dipraglurant|Oral tablet
15729545|NCT05027997|Drug|Placebo|Oral matching placebo tablet
15729546|NCT05027984|Device|Optical coherence tomography|OCT images will be acquired by means of the FD C7 XR system or the OPTIS system (both St. Jude Medical, St. Paul, MN, USA) with a non-occlusive technique.(33) The acquired OCT coronary images will be analyzed on-line using a proprietary OCT console (St Jude Medical, Inc., USA). Definitions and cut-offs for OCT vulnerability parameters derived from available consensus documents and from main IVUS/OCT studies.
15729547|NCT05027984|Device|iFR/FFR/RFR|The iFR and FFR measurements will be obtained using a coronary-pressure guidewire (Pressure Wire / Certus or Aeris for FFR assessment and PressureWire™ X Guidewire/QUANTIEM™ for the RFR assessment by Abbott Vascular, Abbott Park, Illinois, U.S.A; Comet by Boston Scientific, Marlborough, MA, USA), OptoWire by Opsens, Quebec, Canada, or Verrata by Philips, San Diego, CA, USA.).
15729548|NCT05027971|Device|Flexiva Pulse High Power Single-Use Laser Fibers|Flexiva Pulse High Power Single-Use Laser Fibers are intended to be used as a device that transmits Ho:YAG laser energy from cleared laser consoles to urological anatomy.
15729566|NCT05027906|Drug|AT-1501|Investigative Arm
15729567|NCT05027893|Drug|Moxifloxacin 400 mg Oral Tablet|All used film-coated tablets (400 mg moxifloxacin) were administered for the first five days postoperatively, once a day, after the lower third molar surgery.
15729568|NCT05027893|Drug|Cefixime 400 mg Oral Tablet|All used film-coated tablets (400 mg cefixime) were administered for the first five days postoperatively, once a day, after the lower third molar surgery.
15729569|NCT05027893|Other|Placebo|All used film-coated placebo-tablets were administered for the first five days postoperatively, once a day, after the lower third molar surgery.
15729570|NCT05027880|Other|Web-based single-session growth mindset intervention for adolescent anxiety|This proposed study will use a three-arm, parallel group, randomized control trial design to evaluate the efficacy of SIGMA compared to both a web-based growth mindset SSI (SSI-GP) and an active web-based control programme. The concurrent parallel group structure assures that the different groups take part in their respective intervention at the same time.
15729574|NCT05027841|Other|Proprioseption in hemiparetics|Proprioception on balance and gait functions in hemiparetic individuals
15729576|NCT05027802|Drug|Palovarotene|Palovarotene will be taken orally once daily at approximately the same time each day.
15729579|NCT05027776|Biological|2-doses Group among 9-14 years|Subjects were planned to receive two doses of the study vaccine administered intramuscularly according to a 0, 6 month vaccination schedule.
15729580|NCT05027776|Biological|3-doses Group among 9-19 years|Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 2, 6 month vaccination schedule.
15729581|NCT05027776|Biological|3-doses Group among 20-26 years|Subjects were planned to receive three doses of the study vaccine administered intramuscularly according to a 0, 2, 6 month vaccination schedule.
15729582|NCT05027763|Behavioral|high-fiber/low fat|high fiber/low fat preoperative diet
15729583|NCT05027763|Behavioral|fermented|fermented preoperative diet
15729584|NCT05027750|Behavioral|Application of The Theory of Planned Behaviour For Weight Control|The training to be imparted to the participants was applied online in groups of 5-6 people via the Google Meet program. Obesity training consisting of a total of five sessions. Each session lasted for approximately 30 minutes. After the training given to intervention group, the women will be followed-up for 6 months. The women in the intervention group will be given counseling service by the researchers, and their status will be evaluated every month.
15729585|NCT05027737|Procedure|Early Ileostomy Closure|Following a negative leak test (CT scan with rectally-administered water-soluble contrast on post-operative day 7, 8 or 9), patients will undergo standardized reversal of their diverting loop ileostomy (stapled side-side functional end-to end anastomosis, purse-string closure of the ileostomy wound, and no use of epidural analgesia) between post-operative days 10-14.
15729586|NCT05027711|Radiation|ITV (Internal target volume)-based Stereotactic Body Radiotherapy (ITV-SBRT)|ITV (Internal target volume)-based Stereotactic Body Radiotherapy (ITV-SBRT)
15729587|NCT05027711|Radiation|MRgSBRT (Magnetic Resonance-guided Stereotactic Body Radiotherapy)|MRgSBRT (Magnetic Resonance-guided Stereotactic Body Radiotherapy)
15729588|NCT05027685|Device|The Paradise Ultrasound Renal Denervation System|The CE-marked and commercially available ReCor Medical Paradise Ultrasound Renal Denervation System (Paradise System) is a catheter-based device designed to use ultrasound energy to thermally ablate the nerves surrounding the renal artery and serving the kidney.
15729589|NCT05027672|Drug|Gam-COVID-Vac (rAd26) / Gam-COVID-Vac (rAd5)|A comparison of antibody levels against protein S will be performed using the Gam-COVID-Vac / Gam-COVID-Vac group as a control group and all other interventions as comparators.Comparisons will be made by contrasting the geometric means of antibody levels between each of the study arms. In addition, comparisons will be made as to whether or not the median antibody values of the alternative treatment groups are lower than: a) the 25th percentile of the median antibody value of the Gam COVID combination and b) whether the lower limit of the confidence interval of the differences in the GMC rate is lower than the conventional cut-off point of non-inferiority set at 0.67.
15729590|NCT05027659|Other|virtual reality glasses|Virtual reality (VR) glasses have a detachable screen frame compatible with smartphones. A VR headset has earphones and sensors that track the user's head movements, giving them the impression that they are moving around in a virtual environment. The investigators used a smartphone and VR glasses to perform the intervention. They connected the phone to the VR headset via a 360 degree VR video app. Experimental participants wore the VR glasses and watched a 360 degree VR video of nature scenes with ambiance music during colonoscopy. They put on the VR glasses right before the procedure and took them off right afterward.
15729591|NCT05027646|Drug|Sancuso - Part 1|Part 1 - A Potent anti-emetic and highly selective antagonist of 5-HT3 receptors.
15729592|NCT05027646|Drug|Sancuso - Part 2|Part 2 - A Potent anti-emetic and highly selective antagonist of 5-HT3 receptors.
15729593|NCT05027633|Drug|Pembrolizumab|given by IV
15729594|NCT05027633|Drug|Docetaxel|given by IV
15729595|NCT05027633|Drug|Cisplatin|given by IV
15729596|NCT05027633|Drug|Carboplatin|given by IV
15729597|NCT05027620|Other|Motor-cognitive exercise therapy in the home|"Participants engage in a progressive 10-week exercise program targeted at improving motor and cognitive function. Motor exercises target functional strength, gait and physical activity level. Training sessions occur 3 times weekly and supported by a digital application which has been adapted for people with Parkinson's disease. Weeks 1-2 focus solely on motor exercises. Dual-task (Motor-cognitive) exercises are introduced at week 3 and progressed until week 10. Participants are also encouraged to increase the physical activity levels during the 10 week period.
~Weekly contact is made using the video function/ telephone with clinical specialists/ researchers. Two home visits will occur, the first one week prior to the intervention and at the 5-week period. Participants receive motivational messaging and reminders via the app during the intervention period."
15729598|NCT05027607|Procedure|Bascom's pit-pick|Pit-pick procedure of simple pilonidal sinus disease in the natal cleft in a day-surgery setting.
15729599|NCT05027594|Drug|NMS-03597812|All patients will receive NMS-03597812 administered orally once daily on Days 1-21 in repeated 4-week cycles.
15729600|NCT05027594|Drug|NMS-03597812 + dexamethasone|All patients will receive NMS-03597812 administered orally once daily on Days 1-21 and Dexamethasone administered orally once a week on Days 1, 8, 15 and 22 in repeated 4-week cycles.
15729634|NCT05027412|Device|En bloc TURBT Collins Loop|En bloc TURBT Collins Loop
15729635|NCT05027412|Device|Conventional TURBT|Conventional TURBT
15729751|NCT05026541|Behavioral|Shoonya Meditation|This is a 15 minute meditation, described as a process of conscious non-doing.
15729601|NCT05027581|Drug|Bone marrow mesenchymal stem cells|The bone marrow mesenchymal stem cells (BM-MSCs) in Chondrochymal® for this study was obtained from the donor recruited in Taipei Veterans General Hospital, Taiwan. Donors aged 20 to 50 and tested negative to infection of human immunodeficiency virus type 1 and 2 (HIV-1/2), hepatitis B virus (HBV), hepatitis C virus (HCV), Cytomegalovirus (CMV), Treponema pallidum (syphilis), human T-lymphotropic virus types I and II (HTLV-I/II), and Tuberculosis (TB) were enrolled. The eligible donor's bone marrow was aspirated from the iliac crest or femur. The collected BM-MSCs were then cultured, expanded and cryopreserved in a Good Tissue Practice (GTP)-complied laboratory. The qualified cells in cryopreservation meeting the release criteria will be thawed, mixed with lactated Ringer's solution, and transferred into a sterile syringe as the final product.
15729602|NCT05027581|Drug|hyaluronic acid|(60 mg/3 mL hyaluronic acid [HA])
15729603|NCT05027568|Drug|Single ascending doses of IOA-289|Single dose, oral administration of liquid-filled capsules, with a starting dose of 30 mg
15729604|NCT05027568|Drug|Placebo single doses|Single dose, oral administration of liquid-filled capsules, matching placebo
15729605|NCT05027555|Other|Multisensory training|Multisensory training included marching on the foam with visual deprivation and treadmill training with visual deprivation
15729606|NCT05027555|Other|Conventional training|Conventional training included strengthening, balance training and gait training
15729607|NCT05027529|Device|CytoSorb|An extracorporeal cytokine hemoadsorption system is integrated in the VA-ECMO circuit
15729608|NCT05027529|Other|VA-ECMO only|only VA-ECMO; NO extracorporeal cytokine hemoadsorption system is added
15729609|NCT05027516|Drug|Rocephin|Single dose of Rocephine® (= ceftriaxone 1g + lidocaine 35mg) intramuscular injection
15729610|NCT05027516|Drug|Azithromycin|Single dose of Rocephine® (= ceftriaxone 1g + lidocaine 35mg) intramuscular injection + single dose of azithromycin 2g orally
15729624|NCT05027477|Device|Radical Prostatectomy|If you are in this group, you will get the standard of care treatment used to treat this type of cancer: radical prostatectomy. You will undergo this procedure as per standard clinical practice. A radical prostatectomy is a surgical procedure that removes the prostate gland. This is done by making a surgical incision and removing the prostate gland.
15729625|NCT05027477|Device|TULSA Procedure|If you are in this group, you will get the TULSA Procedure. The TULSA Procedure is a minimally invasive procedure that uses directional ultrasound to produce very high temperature to ablate (destroy) targeted prostate tissue. The procedure is performed in a MRI suite (the physician can see the prostate at all times throughout the procedure) and uses the TULSA-PRO system to ablate prostate tissue. The procedure combines real-time MRI with robotically-driven directional thermal ultrasound to deliver predictable, physician-prescribed ablation of the prostate. Minimally invasive here means that the procedure is performed through natural openings in your body (the urethra) instead of creating larger openings like in traditional surgery.
15729627|NCT05027451|Drug|IXT-m200|Anti-methamphetamine chimeric monoclonal antibody (mAb)
15729628|NCT05027451|Other|Placebo|Normal saline
15729629|NCT05027438|Behavioral|Cognitive Behavioral Therapy for Insomnia|A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies
15729630|NCT05027438|Behavioral|Deprescribing|The reduction or withdrawal of a medication, through gradual dose reduction, managed by a healthcare professional that aims to reduce harm and improve outcomes
15729631|NCT05027425|Drug|Durvalumab|1500 mg IV, Q4W
15729632|NCT05027425|Drug|Tremelimumab|300 mg IV, 1 dose on day 1 of only the first cycle
15729633|NCT05027425|Procedure|Liver Transplant|minimum 72-day washout from the end of immunotherapy, patients will undergo liver transplant.
15729636|NCT05027399|Behavioral|Nursing teleconsultation for lifestyle changes|Guidance on better medication adherence, monitoring of signs and symptoms of exacerbation of heart failure, guidance on the need for fluid restriction.
15729637|NCT05027386|Drug|Apatinib, Irinotecan, Temozolomide|The enrolled patients diagnosed with recurrent or refractory pediatric neuroblastoma received apatinib combined with IT regimen chemotherapy, the treatment including combination therapy phase and monotherapy maintenance phase.
15729638|NCT05027373|Drug|SSGJ-613|SSGJ-613 injection is 200mg/2mL solution in a single vial.The solution is a clear to slightly opalescent, colorless to a slightly yellow tint.
15729639|NCT05027373|Drug|Placebo|Placebo injection is 2mL excipient solution in a single vial.The solution is clear and colorless.
15729640|NCT05027360|Drug|SNP - Sodium Nitroprusside|The primary objective of our study is to assess the efficacy and safety of SNP as part of the treatment regimen of AHF patients and to identify predictors of efficacy.
15729641|NCT05027347|Diagnostic Test|plasma circulating tumor DNA|A liquid biopsy assay for identification of tumor derived mutations in plasma of gastric cancer
15729642|NCT05027334|Other|DiaMon - Mobile Application for Type 2 Diabetes mellitus and pre-diabetes|Each participant will be provided with a mobile application aimed at monitoring their clinical markers such as FBG and HbA1c. The mobile application consists of medical details and demographics as well as a section dedicated to daily glucose levels and record of physical activity.
15729643|NCT05027321|Behavioral|Preparation in Self-Hypnosis by anchoring|Preparation in Self-Hypnosis by anchoring just before examination
15729644|NCT05027321|Behavioral|Conversational Hypnosis|Conversational Hypnosis during examination
15729645|NCT05027321|Behavioral|Preparation in Self-Hypnosis by anchoring + Conversational Hypnosis|Preparation in Self-Hypnosis by anchoring just before examination combied with Conversational Hypnosis during examination
15729646|NCT05027308|Drug|Teduglutide|Teduglutide 0.05 mg/kg SC injection
15729647|NCT05027295|Drug|riboflavin ophthalmic solution|Administration of riboflavin one drop every 2 minutes during administration of continuous UVA light for 7.5 minutes.
15729648|NCT05027295|Drug|riboflavin ophthalmic solution|Administration of riboflavin one drop every 2 minutes during administration of pulsed UVA light for 15 minutes
15729649|NCT05027282|Device|CLEAR + BRILLIANT TOUCH(R) 1440-nm and 1927-nm handpieces.|CLEAR + BRILLIANT TOUCH(R) diode laser 1440-nm and 1927-nm Combination Wavelength Treatment.
15729650|NCT05027269|Drug|AOC 1001|AOC 1001 will be administered by intravenous (IV) infusion.
15729651|NCT05027269|Drug|Placebo|Placebo will be administered by intravenous (IV) infusion.
15729652|NCT05027256|Device|Entia Liberty|Home Monitoring solution
15729653|NCT05027243|Procedure|bilateral temporomandibular joint arthroscopy|The TMJ arthroscopy was performed with a 1.9-mm arthroscope including a video system, with a 2.8-mm outer protective cannula. Briefly, for TMJ arthroscopy level 1, the authors used the classic puncture with an entry point 10 mm anterior and 2 mm below the Holmlund-Hellsing (H-H) line. A second puncture with a 21-G needle was performed 30 mm anterior and 7 mm below the H-H line to wash the joint with 250-300 ml Ringer solution. After washing the joint, 1.5-2 cc of hyaluronic acid was injected into it. For level 2 TMJ arthroscopy, the second puncture was substituted by a 2.8-mm outer protective cannula with a sharp trocar until the joint was reached. The 2.8-mm cannula was used for (1) intra-articular coblation and/or (2) intrasynovial medication. Antibiotic and non-steroidal anti-inflammatory drugs were routinely prescribed. Patients were instructed to follow a soft diet for 3 days after surgery and 5 physiotherapy and 3 speech therapy exercise sessions after intervention.
15729654|NCT05027243|Drug|Xeomin® (Merz)|For tenderness grade 2, 155U of Incobotulinum toxin A was injected in the masticatory muscles and for tenderness grade 3 195U of Incobotulinum toxin A was injected. The authors used Xeomin® (Merz) in all patients.
15729657|NCT05027217|Other|No intervention|No intervention. Arms are subdivided based on patients' diagnostic status on admission to ICU.
15729658|NCT05027204|Drug|Docetaxel|Docetaxel for Injection (Albumin-bound), Q3W, i.v. 60 min
15729659|NCT05027204|Drug|Nivolumab|Nivolumab, Q3W, i.v. 30 min
15729660|NCT05027191|Diagnostic Test|Neutrophil Gelatinase-Associated Lipocalin (NGAL)|The evaluation of inhalational anesthetics (desflurane and sevoflurane) on NGAL levels in laparoscopic cholecystectomy patients.
15729661|NCT05027191|Drug|Desflurane|Desflurane
15729662|NCT05027191|Drug|Sevoflurane|Sevoflurane
15729663|NCT05027178|Other|Chiropractic Care|Chiropractic care on stroke participants
15729664|NCT05027165|Other|Non-interventional|No intervention
15729665|NCT05027152|Other|Resistance training|The resistance training group will perform traditional resistance exercises with an intensity of 30%-60% of a voluntary repetition maximum and 1 to 2 sets of 10 repetitions each exercise. The repetitive task training group will carry out exercises involving upper and lower limbs.
15729666|NCT05027152|Other|Repetitive task training|The repetitive task training group will carry out exercises involving upper and lower limbs.
15729667|NCT05027139|Drug|Zanidatamab|Administered intravenously (IV)
15729668|NCT05027139|Drug|Evorpacept|Administered IV
15729669|NCT05027126|Drug|Dexketoprofen 25 MG|Pharmaceutical Form: Tablets Dosage: 25 mg Adminstration way: Oral
15729670|NCT05027126|Drug|Fixed dose Dexketoprofen-Vitamin B Complex|Pharmaceutical Form: capsule Dosage: 25 mg of Dexketoprofen + Cyanocobalamin 500 µg, Thiamine 100 mg, Pyridoxine 50 mg. Administration way: oral
15729672|NCT05027100|Drug|Anlotinib Tislelizumab Irinotecan|Anlotinib 10mg QD 2W stop 1W Tislelizumab injection200mg Q3W Irinotecan (2 cycles) 100mg/m2,d1,d8,Q3W
15729673|NCT05027087|Dietary Supplement|Blueberry gummy|Gummy bear containing blueberry powder
15729674|NCT05027087|Dietary Supplement|Placebo gummy|Gummy bear with no active ingredients
15729679|NCT05027035|Other|Preparatory study|10 participants for surgical plication and 10 participants for nocturnal non-invasive ventilation.
15729680|NCT05027009|Procedure|Physical Examination|Undergo total body exam
15729681|NCT05027009|Other|Solar Simulated Light|Undergo exposures to simulated sunlight
15729682|NCT05026996|Drug|Pelacarsen|Single subcutaneous injection of pelacarsen
15729683|NCT05026996|Drug|Pelacarsen|Single subcutaneous injection of pelacarsen
15729684|NCT05026983|Drug|Binimetinib|Given PO
15729685|NCT05026983|Drug|Encorafenib|Given PO
15729686|NCT05026983|Other|Questionnaire Administration|Ancillary studies
15729687|NCT05026970|Combination Product|Biofeedback+Electrostimulation+Kegel|Biofeedback (3 sessions) Electrostimulation (12 weeks daily treatment) Kegel exercises (twice daily)
15729688|NCT05026970|Device|Biofeedback+Tibial Neuromodulation+Kegel|Biofeedback (3 sessions) Transcutaneous Neuromodulation (12 weeks daily treatment) Kegel exercises (twice daily)
15729689|NCT05026970|Combination Product|Biofeedback+Kegel|Biofeedback+Kegel exercises
15729690|NCT05026957|Device|SharedHeart|A smartphone application
15729691|NCT05026944|Other|Percussive massage and static stretching exercises|All the study participants will perform 15 minutes treadmill, 15 minutes stationary bicycle at day one. After 24 hours participants with positive DOMS will be treated with 5 minutes of percussive massage and 5 minutes of static stretching exercises. The group will be assessed on Numeric Pain Rating Scale and Short-Form McGill Pain Questionnaire for pain and degree of passive ankle dorsi flexion for calf muscle length at baseline before intervention and immediate 24 hours, 48 hours and 72 hours after the completion of treatment session.
15729692|NCT05026944|Other|static stretching exercises|All the study participants will perform 15 minutes treadmill, 15 minutes stationary bicycle at day one. After 24 hours participants with positive DOMS will be managed with 5 minutes of static stretching exercises only. The group will be assessed on Numeric Pain Rating Scale and Short-Form McGill Pain Questionnaire for pain and degree of passive ankle dorsi flexion for calf muscle length at baseline before intervention and immediate 24 hours, 48 hours and 72 hours after the completion of treatment session.
15729693|NCT05026931|Other|Foam rolling|Group A will be treated with foam rolling effect on quadriceps, hamstring and calf muscle length. 5 min cycle ergometry, 6 min foam rolling 3 times for 30sec.For three session per week will be given atleast for 2 months.
15729694|NCT05026931|Other|Stretching exercises|Group B will be treated with stretching exercises effect on quadriceps, hamstring and calf muscle length. 5 min cycle ergometry, 6 min foam rolling 3 times for 30sec.For three session per week will be given atleast for 2 months.
15729695|NCT05026918|Other|MCPT|Postural Drainagewith percussion and vibration
15729696|NCT05026918|Other|ACBT|ACBT includes Breathing control techniques, chest expansion exercises and Forced Expiration Technique
15729697|NCT05026905|Drug|Gemcitabine|Gemcitabine 800mg/m2 in N/S 250ml over 30 minutes (or fixed dose rate 10 mg/m2/min) IV infusion on day 1 repeated every 14 days.
15729698|NCT05026905|Drug|nab-paclitaxel|Nab-paclitaxel 125mg/m2 over 30 minutes IV infusion on day 1 repeated every 14 days, followed by Gemcitabine
15729699|NCT05026905|Drug|S-1|"S-1 orally 60-100 mg/day day 1 to 7 on in a 2-week cycle. The dose of S-1 is defined as follows:
~BSA < 1.25 m2: 60 mg/day
~1.25 m2 ≤ BSA < 1.5 m2: 80 mg/day
~BSA ≥ 1.5 m2: 100 mg/day"
15729700|NCT05026905|Drug|leucovorin|leucovorin 30mg BID day 1 to 7 on in a 2-week cycle
15729701|NCT05026905|Drug|oxaliplatin|Oxaliplatin 75mg/m2 in 250 mL of D5W over 120 minutes IV infusion on day 1 repeated every 14 days
15729702|NCT05026892|Other|no intervention|no intervention, only collection of data
15729703|NCT05026879|Biological|Inactivated COVID-19 vaccine (CoronaVac)|The adverse events due to an inactivated COVID-19 vaccine.
15729706|NCT05026853|Behavioral|PRO Integration into Clinical Practice|HCPs will document their discussion and recommendations/referrals in MiChart (Epic EMR)
15729707|NCT05026840|Procedure|GDM screening criteria|difference in risk factors and clinical outcomes between groups
15729708|NCT05026827|Other|Iyengar Yoga|Participation in Iyengar Yoga classes
15729709|NCT05026827|Other|Socialization Control|Participation in socialization control group sessions
15729710|NCT05026814|Other|Interview after one year or more from the treatment received|Questionnaires to evaluate the satisfaction with treatment, the motivations and expectations for the treatment, the general well-being, the sexual function and the genital selfimage
15729713|NCT05026775|Behavioral|Initial Medication Adherence (IMA)|"The IMA intervention is a shared-decision making intervention that promotes health literacy and patient participation in the decision making process during the recommendation and prescription of a new drug for the management of a cardiovascular disease and diabetes.
~The IMA intervention has four main components: training for healthcare professionals (general practitioners (GP), nurses and community pharmacists) on non-initiation, shared-decision making, health literacy and use of decision aids; intervention decision aids (leaflets and website); implementation of the IMA intervention during the GP's consultation; and information support provided by the nurses and community pharmacists that will use the intervention decision aids to explore the patients's doubts and harmonise and standardise the discourse between primary healthcare professionals."
15729714|NCT05026775|Other|Usual care|Health professionals in the usual care group will prescribe medication and provide information as usual.
15729747|NCT05026567|Combination Product|ZENEO® Midazolam (10 mg/0.625 mL) ventrogluteal area|ZENEO® Midazolam (10 mg / 0.625 mL) ventrogluteal area
15729748|NCT05026567|Combination Product|ZENEO® Midazolam (10 mg/0.625 mL) thigh through clothing|ZENEO® Midazolam (10 mg / 0.625 mL) thigh through clothing
15729749|NCT05026554|Genetic|Tape stripping|Optional genetic analysis for chronic hand eczema
15729750|NCT05026541|Behavioral|Nap Practitioners|Regular nappers will be given a 30 minute nap opportunity to nap for as long as they please.
15729715|NCT05026762|Other|Treatment|Following the collection of the baseline data, the study participant will be assigned to a volunteer(medical student) to begin the social phone calls. The first phone call will be scheduled to occur within one week of the consent and baseline assessments. A minimum of one social phone call will occur each week for 6-weeks. Each phone call is expected to last up to 1 hour.The calls will be unstructured and designed simply to engage in conversation with the participant. The length of the phone calls, days and times will be recorded by the volunteer along with a short journal entry describing the conversation topics and any information that stood out to the volunteer.At the end of the 6-weeks phone calls, a group session will be held with the volunteers to engage in a debriefing and narrative medicine session.
15729716|NCT05026749|Drug|AZM Group|AZM at 20 mg/kg will be given intravenous daily for 3 days once patients are consented and enrolled into the study.
15729717|NCT05026749|Other|Control Group|Saline will be given intravenous daily for 3 days once patients are consented and enrolled into the study.
15729718|NCT05026736|Other|Quality-of-Life Assessment|Ancillary studies
15729719|NCT05026736|Biological|Sintilimab|Given IV
15729720|NCT05026723|Behavioral|MTM + ILI|Weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 20-session telephone lifestyle intervention change program
15729721|NCT05026723|Behavioral|Standard MTM|Weekly home meal delivery; an explanation of the medical tailoring of the meals; and an initial consultation with a dietitian
15729722|NCT05026710|Device|Silicone (Coloplast Imajin Hydro) ureteral stent|During the end of the standard of care ureteroscopy the silicone stent will be placed.
15729723|NCT05026710|Device|Non-silicone (Polyurethane/Percuflex) ureteral stent (any manufacturer)|During the end of the standard of care ureteroscopy the Non-silicone (Polyurethane/Percuflex) stent will be placed.
15729724|NCT05026684|Other|Personalized cost handout|Patients will be given a personalized cost handout to make transparent the full costs to Veterans of different types of ambulatory visits in order to optimize the value of their health care investments.
15729725|NCT05026671|Procedure|Endotracheal Tube Alone|Intubating the trachea with an endotracheal tube alone ( without stylet).
15729726|NCT05026671|Procedure|Endotracheal Tube+ Stylet|Intubating the trachea with an endotracheal tube + stylet.
15729727|NCT05026671|Procedure|Endotracheal Tube + Video-laryngoscope|Intubating the trachea with an endotracheal tube + Video- laryngoscope
15729728|NCT05026671|Procedure|Endotracheal tube + stylet with Video-laryngoscope|Intubating the trachea with an endotracheal tube + stylet + Video-laryngoscope
15729729|NCT05026658|Device|Visibly Digital Acuity Product|"The order of testing (two VDAP home environments and ETDRS) will be randomly assigned for each subject as one of four sequences:
~V1, E, V2
~E, V1, V2
~V2, E, V1
~E, V2, V1
~Where E denotes the ETDRS assessment, V1 denotes the VDAP assessment in home environment 1, and V2 denotes the VDAP assessment in home environment 2.
~The randomization will be blocked in groups of 4 subjects to ensure balance for the VA testing sequences."
15729730|NCT05026645|Procedure|Clinical interventions performed in acute settings (contaminated environment)|Any clinical intervention performed on the patient inflicted by the chemical weapon in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic).
15729731|NCT05026645|Procedure|Protection (clinician and patient)|As interrelated competence of the clinical intervention, any protection procedure and capability applied on the patient inflicted by the chemical weapon in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic). Concerning the clinician, the protection implied for his/her own safety and for the patient to whom she/he was in closed/contact with.
15729732|NCT05026645|Procedure|Decontamination (clinician and patient)|As interrelated competence of the clinical intervention and protection, any decontamination procedure and capability applied on the patient inflicted by the chemical weapon in acute settings (from the incident site up to his/her admission to the clean zone of a emergency room or its equivalent (ie.: walking clinic). Concerning the clinician, the protection implied for his/her own safety and for the patient to whom she/he was in closed/contact with. This crucial step is usually expected prior the patient's transfer into a clean zone like the emergency room or its equivalent.
15729733|NCT05026632|Drug|NPI-002 Intravitreal Implant|Implant inserted during vitrectomy.
15729734|NCT05026619|Other|Information about age-related fertility|"The following information is provided:
~Age and fertility IVF success rates and side effects"
15729735|NCT05026619|Other|Information about policy initiatives|"The following information is provided:
~Assisted reproductive technology treatment subsidies Other fertility-related policies"
15729736|NCT05026619|Other|Information about diabetes|"The following information is provided:
~Diabetes risk factors and treatment Diabetes-related policies"
15729737|NCT05026606|Biological|Etigilimab|Given IV
15729738|NCT05026606|Biological|Nivolumab|Given IV
15729739|NCT05026593|Drug|Carboplatin|Carboplatin will be administered after completion of Sintilimab by IV infusion to achieve an initial target AUC of 5 mg/mL/min on Day 1.
15729740|NCT05026593|Drug|Cisplatin|Cisplatin 75 mg/m^2 will be administered after completion of Sintilimab by IV infusion on Day 1.
15729741|NCT05026593|Drug|Etoposide|Etoposide 100 mg/m^2 will be administered by IV infusion following carboplatin or cisplatin administration, during the induction phase on Day 1 through 3 of each cycle. On Days 2 and 3, patients will receive etoposide alone.
15729742|NCT05026593|Drug|Sintilimab|Sintilimab 200 mg will be administered by IV infusion following IBI110 on Day 1 of each 21-day .
15729743|NCT05026593|Drug|IBI110|IBI110 RP2D will be administered by IV infusion on Day 1 of each 21-day .
15729744|NCT05026580|Behavioral|Joint Academy exercise and education smart phone application|The Joint Academy® (www.jointacademy.com) program for people with hip or knee OA consists of video instructed and progressively adaptable daily exercises, patient education through text lessons and a continuous asynchronous chat function with a personal reg. physiotherapist who supervises the patient during the full participation period.
15729745|NCT05026567|Combination Product|ZENEO® Midazolam on bare skin (10 mg/0.625 mL)|ZENEO® Midazolam on bare skin (10 mg/0.625 mL)
15729746|NCT05026567|Drug|2 mL of DORMICUM® Midazolam Hydrochloride (15 mg/ 3 mL) or DORMICUM® Midazolam Hydrochloride (5 mg/ 1 mL)|Either the i.m. injection of either the reference product, DORMICUM® (15 mg/ 3mL) or the i.m injection of 2mL of the reference product, DORMICUM® (5 mg/ 1 mL) administered with a conventional syringe in the thigh on bare skin
15729752|NCT05026541|Behavioral|Shukha Kriya Practice|This is a practice of alternate nostril breathing, in which one nostril is closed by the right hand while breathing occurs slowly through the other. The open nostril is alternated after every inhalation.
15729753|NCT05026528|Other|Digital diabetes self management education and support system|Digital diabetes self management and support system
15729754|NCT05026515|Behavioral|Parents|To observe the influence of the parents/caregivers behavior on their child during dental treatment
15729755|NCT05026489|Genetic|G6PD gene deficiency|we will use tetrazolazole-blue quantitative method to detect whether the patient suffer from G6PD deficiency.
15729756|NCT05026476|Dietary Supplement|Resource Thicken up Junior|Each infant and child will be switch over to receive for a period of 7 days (new thickener)
15729757|NCT05026463|Procedure|Inspiratory support level|Inspiratory support is the pressure delivered by the ventilator during pressure support ventilation.
15729758|NCT05026437|Other|Cardiac surgery score and APACHE II scoring|Cardiac surgery score and APACHE II will calculated on the first postoperative day.
15729761|NCT05026411|Diagnostic Test|T 0 Diffusion Tensor MR|Magnetic resonance images has been taken from 20 individuals with eating disorders before fixed orthodontic treatment
15729762|NCT05026411|Diagnostic Test|T 1 Diffusion Tensor MR|Magnetic resonance images will be taken from 20 individuals with eating disorders after 12 months of orthodontic treatment.
15729763|NCT05026411|Diagnostic Test|T 2 Diffusion Tensor MR|Magnetic resonance images will be taken from 20 individuals with eating disorders 6 months after orthodontic treatment finished
15729764|NCT05026398|Drug|Fenfluramine|Fenfluramine (30mg daily) will be dispensed in a cherry flavoured aqueous solution. Fenfluramine is both a serotonin releasing agent and sigma-1 receptor agonist. Fenfluramine is FDA approved for the treatment of Dravet syndrome, a rare form of epilepsy.
15729765|NCT05026398|Other|Placebo|The placebo is a liquid designed to be identical to the interventional drug fenfluramine in terms of both taste and visual appearance. It will be administered at 30mg daily and dispensed in a cherry flavoured aqueous solution
15729766|NCT05026385|Behavioral|Intervention|Targeted nutrition advice, progressive resistance training exercise, and self-management support
15729767|NCT05026372|Behavioral|Mindfulness Compassion (MC)|The interventionist will review the tools the couples had learned over the course of this program and help them proactively identify strategies to continue to implement them into their lives. Couples will receive instructions on how to continue with this program when no longer meeting with the interventionist.
15729768|NCT05026372|Behavioral|Mindfulness Gratitude (MG)|The interventionist will review the tools the couples had learned over the course of this program and help them proactively identify strategies to continue to implement them into their lives. Couples will receive instructions on how to continue with this program when no longer meeting with the interventionist.
15729769|NCT05026372|Behavioral|Mindfulness Value-Based Living (MV)|The interventionist will review the tools the couples had learned over the course of this program and help them proactively identify strategies to continue to implement them into their lives. Couples will receive instructions on how to continue with this program when no longer meeting with the interventionist.
15729770|NCT05026359|Device|Bilateral ankle coordination training|Developed a novel bilateral ankle coordination training program with visual feedback and bilateral ankle control, based on the concept of bilateral movement therapy. The bilateral ankle coordination training includes 3 days a week, 30 minutes each time, lasting 4 weeks, and a total of 12 training sessions.
15729771|NCT05026346|Diagnostic Test|Pathologic Exercise|"In the first phase of the project, a series of 5 active shoulder mobilization exercises characterized by an adequate range of motion will be tested to verify the set up for the video recording.
~In the second phase shoulder movements will be recorder by a smartphone.
~A questionnaire will be used and adapted on the basis of which to evaluate the correctness of the exercises performed by each healthy subject / patient. This questionnaire will provide a Clinical Score (CS) which assigns a numerical value to the patient's overall performance for each repetition.
~The videos of each repetition of exercises performed by the healthy subjects / patients will then be evaluated by two different clinicians, blinded, using the questionnaire.
~The Artificial Intelligence learning algorithm will be able to output an evaluation score that will be compared with that produced by clinicians."
15729772|NCT05026333|Other|Cognitive Stress Testing|Cognitive and stress study with no product intervention and noninvasive. The high stress/anxiety group will be compared to the low stress/anxiety group in terms of changes from baseline to after the cognitive and stress tests (i.e., 4 laboratory tasks) and metabolite measures.
15729773|NCT05026320|Drug|Naproxen gel|10%, bid for 5 days (final application on morning of Day 6)
15729774|NCT05026320|Drug|Diclofenac gel|2.32% bid for 5 days (final application on morning of Day 6)
15729775|NCT05026320|Drug|Placebo gel|bid for 5 days (final application on morning of Day 6)
15729776|NCT05026307|Procedure|Excision of pterygium|Simple surgical excision of pterygium with bare sclera
15729777|NCT05026294|Other|plyometric exercises|Exercises for strength and flexibility
15729778|NCT05026294|Other|Exercises for flat feet rehabilitation|Exercises for intrinsic muscles strength
15729779|NCT05026281|Device|Quantra analyzer|one additional tube will be collected during the usual blood test at two different time and analyzed by Quantra ®
15729780|NCT05026268|Procedure|intracorporeal anastomosis|"intracorporeal stapled side-to-side isoperistaltic anastomosis"
15729781|NCT05026255|Procedure|alveolar recruitment manoeuvre by pressure step|The application of alveolar recruitment manoeuvres consists of transiently increasing alveolar pressure in order to re-open collapsed alveolar territories and to re-ventilate poorly ventilated or non-ventilated lung areas.
15729782|NCT05026242|Behavioral|Almond intervention|Participants will follow their regular Western-style diet substituting unhealthy snacks by 2-daily servings of almonds
15729783|NCT05026242|Behavioral|Control|Participants will be provided with isocaloric snacks
15729817|NCT05025956|Drug|Placebo|Fisetin appearance-matched microcrystalline cellulose placebo. 20 mg/kg taken for 8 days total.
15729784|NCT05026229|Drug|dasatinib plus consolidation chemotherapy with vincristine and prednisone|After induction therapy, the patients in the 'Dasatinib, Vincristine and Prednisone' group will receive dasatinib and consolidation chemotherapy with vincristine and prednisone.
15729785|NCT05026229|Drug|dasatinib plus consolidation chemotherapy with high-dose methotrexate and cytarabine|After induction therapy, the patients in the 'Dasatinib, Methotrexate and Cytarabine' group will receive dasatinib and consolidation chemotherapy with high-dose methotrexate and cytarabine.
15729786|NCT05026216|Drug|Qwo|Collagenase clostridium histolyticum-aaes is a combination of bacterial collagenases AUX-I and AUX-II, in an approximate 1:1 mass ratio, which are isolated and purified from the fermentation of Clostridium histolyticum bacteria. Collagenase AUX-I is a single polypeptide chain consisting of approximately 1000 amino acids. Collagenase AUX-II is a single polypeptide chain consisting of approximately 1000 amino acids.
15729787|NCT05026203|Drug|Ketamine Hydrochloride|Ketamine hydrochloride 0.5 mg/kg intravenous administer in 40 minutes per day for 3 consecutive days
15729788|NCT05026203|Drug|Midazolam|Midazolam
15729789|NCT05026190|Diagnostic Test|transrectal ultrasound|we perform trus to identify the cause of azospermia and its type either obstructive or not
15729790|NCT05026177|Drug|Simufilam|Simufilam is a novel drug candidate designed to treat and slow the progression of AD. Simufilam binds with femtomolar affinity to an altered conformation of filamin A that is present in the brain of patients with AD and critical to the toxicity of Aβ42. In this study, simufilam will be given b.i.d. for 76 weeks at a dose of 50 mg or 100 mg.
15729791|NCT05026177|Drug|Placebo|Matching placebo given b.i.d. for 76 weeks
15729792|NCT05026164|Dietary Supplement|CHI-202|Blend of cannabinoids & other ingredients
15729793|NCT05026164|Dietary Supplement|CHI-101|Placebo
15729794|NCT05026151|Other|Nutrition therapy according to ICU protocol|The study aims a verifying adherence to the ICU nutrition protocol
15729795|NCT05026125|Drug|Remifentanil Injection|Injection of 3 μg/kg (Ideal Body Weight) of Remifentanil in the induction phase of anesthesia for orotracheal intubation for bariatric surgery
15729796|NCT05026125|Drug|Remifentanil Injection plus 30%|Injection of 3 μg/kg (Ideal Body Weight) plus 30% of Remifentanil in the induction phase of anesthesia for orotracheal intubation for bariatric surgery
15729797|NCT05026112|Diagnostic Test|ECG-Imaging|ECG imaging acquisition
15729798|NCT05026112|Diagnostic Test|Cardiac MRI scan|Cardiac MRI scan
15729799|NCT05026099|Other|Boxing training|Boxing training: warm-up. Mitt hitting, sandbag hitting, in sitting, cool down, Assessment after 4 weeks boxing training: warm-up. Mitt hitting, sandbag hitting, below hips, cool down, Assessment after 6 weeks Boxing training: warm-up. Mitt hitting, sandbag hitting, both inn sitting and standing, cool down, Post assessment
15729800|NCT05026099|Other|Task Oriented Training|Task-oriented training: 6 tasks in sitting and standing position for both upper and lower limb Assessment after 4 weeks Task oriented training: 6 tasks in sitting and standing position for both upper and lower limb Assessment after 6 weeks Task oriented training: 6 tasks in sitting and standing position for both upper and lower limb Post assessment
15729801|NCT05026086|Other|pressure biofeedback|10 patients will be treated with isometric exercises and pressure biofeedback.
15729802|NCT05026086|Other|isometric exercises|10 patients will be treated with isometric exercises
15729803|NCT05026073|Behavioral|Information about clinical risk factors for endometrial cancer and endometrial hyperplasia|age, race, parity, body mass index, last menstrual period, menstrual cycle type, hypertension, type II diabetes, anovulation, polycystic ovary syndrome, indication for hysterectomy and smoking history. Other epidemiologic risk factors including tamoxifen exposure, history of breast cancer, current hormone therapy use, anticoagulant use, oral contraception use, family history of endometrial, breast or colon cancer.
15729804|NCT05026073|Procedure|Blood and endometrial tissue sampling|"All women will undergo planned hysterectomy.
~Venous blood sample will be collected prior to surgery.
~Endometrial sampling via Pipelle device will be performed immediately prior to hysterectomy
~Endometrial biopsy from the hysterectomy specimen will be obtained under direct vision
~The plasma and serum obtained from the blood samples will be analysed with ATR-FTIR and Raman spectroscopes. Spectra from both wet and dry specimens will be recorded.
~All tissue samples retrieved will be placed in Phosphate Buffered Solution for transfer to the histopathology laboratory. Spectra will be collected from the fresh samples with ATR-FTIR and Raman spectroscopes. Spectral analyses will subsequently be repeated on dry samples post fixation and processing.
~All tissue samples will undergo haematoxylin and eosin staining after spectral analysis for standard histopathological confirmation."
15729805|NCT05026073|Procedure|Lymph node sampling|"Lymph nodes will be excised if recommended as part of the standard treatment for endometrial cancer.
~Each node will be cut in half or in quarters, depending on size, to expose the core. Wet and dry spectral analysis will be performed, followed by staining for histopathological confirmation."
15729806|NCT05026060|Diagnostic Test|Imaging|4-minutes eASL sequence without injection of contrast product added to each of the clinical MRs with standard ASL sequences performed for the care of the patient for 3 years.
15729807|NCT05026047|Other|HPV self-sampling|HPV self-sampling in HIV-positive women
15729808|NCT05026034|Device|non-invasive Cardiopulmonary Management (CPM) wearable device|non-invasive Cardiopulmonary Management (CPM) wearable device with measures of congestion in heart failure
15729809|NCT05026021|Biological|Blood sample|For each patient blood (17 ml of whole blood) will be collected during a peripheral venous blood sample carried out in the the standard care at inclusion visit, M3 visit (3 months after inclusion) and M6 visit ( (6 months after inclusion)
15729812|NCT05025995|Behavioral|Serious health game|Serious health game
15729813|NCT05025982|Procedure|combination of lymphaticovenular anastomosis and liposuction|Surgeries were carried out under local anesthesia and light sedation.LVA was performed adopting supramicrosurgical technique.Liposuction was performed following completion of the LVA
15729814|NCT05025969|Other|Glioma data collection|Glioma data collection
15729815|NCT05025969|Other|Brain metastasis data collection|Brain metastasis data collection
15729816|NCT05025956|Drug|Fisetin|Oral Fisetin 20 mg/kg taken for 8 days total.
15729818|NCT05025943|Other|Diet intervention|The intervention group will receive diet counseling and information to implement a standard lifestyle intervention plus omega-3 fatty acid enriched foods Diet assessment and counseling provided throughout study.
15729819|NCT05025943|Other|Control group|The control group will receive diet counseling and information to implement a standard lifestyle intervention Diet assessment and counseling provided throughout study.
15729820|NCT05025930|Device|endoscopic surgical instrument control system (SP1000: single-port laparoscopy)|The system will be used in conjunction with other equipment during endoscopic surgery to accurately control endoscopic surgical instruments and perform delicate surgical procedures such as grasping, cutting, blunt separation, hemostasis, ligation and suture.
15729821|NCT05025930|Device|endoscopic surgical instrument control system (IS3000: multi-port laparoscopy)|The system will be used in conjunction with other equipment during endoscopic surgery to accurately control endoscopic surgical instruments and perform delicate surgical procedures such as grasping, cutting, blunt separation, hemostasis, ligation and suture.
15729822|NCT05025917|Dietary Supplement|Shatavari|Shatavari root powder
15729823|NCT05025917|Dietary Supplement|Magnesium stearate|Magnesium stearate powder
15729824|NCT05025904|Behavioral|Real-time fMRI neurofeedback (rt-fMRI NFB)|Real-time fMRI neurofeedback targeting control of the left medial prefrontal cortex. Participants continuously received visual feedback on the level of activity within the 2D region of interest corrected to the whole-slice brain volume activity. Up- and downregulation blocks were switched for better control.
15729825|NCT05025904|Behavioral|Сognitive behavioral therapy (CBT)|A combination of individual and small-group cognitive behavioral therapy by an experienced medical psychologist and a psychiatrist.
15729826|NCT05025904|Behavioral|EEG neurofeedback (EEG NFB)|EEG neurofeedback targeting frontal alpha asymmetry index. Participants continuously received visual feedback on their frontal alpha asymmetry index. Up-regulation condition only was utilized.
15729827|NCT05025891|Other|Teleconsultation|Patients are randomized into groups in which there are either teleconsultations alone or with the help of a mediator to carry out their follow-up care
15729828|NCT05025878|Dietary Supplement|[U-13C]Glucose|Patients are intravenously infused with 28g of [U-13C]glucose over a 5 hour period. Briefly, [U-13C]glucose will be provided by intravenous line containing 8g of [U-13C]glucose in 60 mL over 10 min. After 10 minutes, 4g of [U-13C]glucose will be administered over an hour. This process will continue until the patient's ascites is drained, or after 5 hours. We will monitor blood glucose levels during infusions using a continuous glucose monitor.
15729829|NCT05025865|Drug|Sodium Hyaluronate|Sodium Hyaluronate of molecular weight 35 kDa will be given in capsule form to the study participants.
15729830|NCT05025865|Drug|Placebo|A placebo will be given in capsule form to study participants.
15729831|NCT05025839|Other|No Intervention|No Intervention takes place, Patients are being observed and classified according to disease severity
15729832|NCT05025826|Other|Phycocare|Phycocare every day during 9 months (except days of chemotherapy: no Phycocare)
15729833|NCT05025826|Other|Placebo|Placebo every day during 9 months (except days of chemotherapy = no Placebo)
15729834|NCT05025813|Drug|Pembrolizumab|Delivery of neo-adjuvant Pembrolizumab
15729835|NCT05025800|Drug|CD47 Antagonist ALX148|Given IV
15729836|NCT05025800|Drug|Lenalidomide|Given PO
15729837|NCT05025800|Biological|Rituximab|Given IV
15729841|NCT05025774|Other|Physical activity|Participant Reported Physical Activity and Outcomes (completed via REDCap or on paper)
15729842|NCT05025761|Other|Personal protection package|The personal protection package will be distributed to mobile and migrant peoples in each village according to the stepped wedge design.
15729843|NCT05025748|Behavioral|Behavioral Intervention|Complete questionnaires
15729845|NCT05025722|Other|Non Interventional|This is an observational study.
15729846|NCT05025696|Other|Blacksoap(R)|Blacksoap(R)
15729847|NCT05025670|Behavioral|Supportive psychotherapy|Participants will receive monthly 30-45 minute supportive psychotherapy sessions. Supportive psychotherapy is an integrative and eclectic psychotherapeutic approach, based upon the individual's needs and symptoms. It draws from elements of a variety of psychotherapeutic disciplines, including cognitive-behavior, psychodynamic, and interpersonal therapies.
15729848|NCT05025657|Behavioral|ALLY|ALLY is a universal, school-based prevention program that takes place during the school day with individual students over 6 weeks.
15729849|NCT05025644|Drug|Pre and post-CPB Drug: Dobutamine Hydrochloride|"Pre-CPB provocation test with DBT stress test will be started (starting at 5 mcg/kg/min, increasing every 3 min, to 10, 15 and 20 mcg/kg/min) until a PG ≥ 50mmHg is achieved (DBT peak dose). The DBT peak dose (DBT-pd) will be recorded.
~Post-CPB provocation test at the DBT-pd achieved preoperatively."
15729850|NCT05025644|Drug|Post-CPB Drug: Dobutamine Hydrochloride|"Pre-CPB no intervention will be required.
~Post-CPB provocation test with DBT stress test will be started (starting at 5 mcg/kg/min, increasing every 3 min, to 10, 15 and 20 mcg/kg/min) or until postoperative provocable PG is >16 mmHg."
15729851|NCT05025605|Drug|BXCL501|Sublingual film containing 80 Micrograms BXCL501
15729852|NCT05025605|Drug|Placebo Film|Matching Sublingual Placebo film
15729853|NCT05025605|Drug|BXCL501|Sublingual film containing 120 Micrograms BXCL501
15729854|NCT05025592|Drug|Regorafenib|patients will received TACE-HAIC and regorafenib and anti-PD1 antibody or not
15729855|NCT05025592|Device|cTACE/DEB-TACE-HAIC|conventional transarterial chemoembolization(cTACE)/transarterial chemoembolization (DEB-TACE) plus hepatic artery infusion
15729856|NCT05025579|Other|Aerobic Exercise|"Since up in 2 min 10 repetitions active joint movement (while seated knee flexion and extension the ankle plantar and dorsal flexion , standing the hip flexion , extension the , abduction and adduction ) , treadmill for 3 minutes, 0.5 m / sec speed walk with and to adapt both warming bike 5 minutes, RPE ( Rating of Perceived exertion discoverable by exertion rate) will be 2/10 in a way was built.
~As aerobic exercise, the first week will be RPE 4/10 for 10 minutes, the second week with RPE 4/10 12 minutes, the third week with RPE 4/10 14 minutes, the fourth week with RPE 4/10, 16 minutes, the fifth week with RPE 5/ 2 0 will be as 18 minutes sixth week RPA 10.6 will form was done 20 minutes of exercise .
~Cooling period in the RPE 2.10 will be the 5 minute turning cycling, 5 min active range of motion exercises and stretching was done."
15729857|NCT05025566|Diagnostic Test|Cognitive (behavioural and neurophysiological) screening|"Cognitive disorders are attested at the behavioral level by the psychologist specialized in neuropsychology who makes the patient take a standardized battery of specific psychometric tests. This assessment thus makes it possible to obtain behavioral data such as reaction time, error rates and modeling parameters.
~The electroencephalogram (EEG) consists of collecting the signal of the brain's bioelectrical activity by means of electrodes placed on the scalp. The EEG is used to determine the cerebral functioning underlying cognitive functions by performing it simultaneously with the behavioral tasks of the neuropsychological assessment, thus obtaining a neurophysiological phenotyping of cognitive disorders."
15729858|NCT05025553|Dietary Supplement|Gut mobilization|Polyethylene Glycol (PEG) at the Dose of 6.9 g/d Once a Day for 6 Month. Children were observed and tested at baseline (T0), 1 month (T1) and 6 months (T2) after gut mobilization.
15729859|NCT05025540|Diagnostic Test|ultrasonic imaging|Two-dimensional ultrasound images of the patient's kidneys were obtained by ultrasound imaging.
15729860|NCT05025527|Diagnostic Test|biparametric MRI (bpMRI)|Men go for the mpMRI for PCa screening, those who had a suspicious result will go for the next confirmation test
15729861|NCT05025527|Diagnostic Test|Prostate cancer antigen (PSA)|Men go for the PSA test for PCa screening, those who had a suspicious result will go for the next confirmation test
15729862|NCT05025501|Behavioral|Family based Executive Function Training|Training the executive funtions of shcoolage ADHD children through tasks and games repeatly but with fun. Giving the parental training and support for the parenting role parents strategies to help the shcoolage ADHD childred coping the symptoms and develop EF in the reallife and improve parent-child relationship.
15729863|NCT05025488|Drug|Peptide-based vaccine|ten (10) doses of Mutant-CALR peptides with KLH as helper peptide (in the first vaccine only). Mutant-CALR vaccine will administered every 2 weeks for the first 4 doses and then every 4 weeks for additional 6 doses. Maintenance Treatment The protocol allows for a continued administration of up to four (4) additional Mutant-CALR vaccine and four (4) Poly-ICLC administrations, 12 weeks apart.
15729864|NCT05025488|Drug|Poly ICLC|ten (10) doses of Poly-ICLC. Poly-ICLC will be given on weeks 1, 3, 5, 7, 11, 15, 19, 23, 27 and 31. each Poly-ICLC dose must be given the day after the corresponding Mut-CALR vaccination.
15729865|NCT05025475|Device|NobleStitch EL|Closure of PFO using NobleStitch EL Closure System
15729866|NCT05025475|Device|Amplatzer|Closure of PFO with FDA approved Amplatazer PFO closure device
15729867|NCT05025462|Dietary Supplement|Supplement dose 15g/d|Supplementation with 15g/day of SPF or Comparator
15729868|NCT05025462|Dietary Supplement|Supplement dose 7.5g/d|Supplementation with 7.5g/d of SPF ou comparator
15729871|NCT05025436|Device|Acupoint stimulation with low energy laser (Erger laser pen)|Each subject was given the same main acupoints (5 acupoints) and physique matching acupoints (1-2 acupoints) interventional low-energy laser (Erger laser pen) acupoint stimulation, set wavelength 810nm +/-10%, The power is 200mW, and the Bahr parameter (B2: 1199 Hz; B3: 2398 Hz) module is selected according to the acupoints. The treatment time is 30 seconds per acupoint, and the treatment dose is 3 joules per acupoint three times a week. After a period of 4 weeks, after a 2-week pause, After the two groups crossed for 4 weeks, each subject was given the same main acupoints (5 acupoints) and physique matching acupoints (1-2 acupoints) with low-energy laser (Erjie laser pen) acupoint stimulation. Set wavelength 810nm +/-10%, power 200mW, select Bahr parameter (B2: 1199 Hz; B3: 2398 Hz) module according to acupoints, treatment time is 30 seconds per acupoint, and treatment dose is 3 joules per acupoint three times a week for a period of time 4 weeks.
15729873|NCT05025410|Drug|Remimazolam|Loading for anesthesia induction: Remimazolam 12 mg/kg/h until loss of consciousness Continuous infusion for anesthesia maintenance: Remimazolam 1-2 mg/kg/h under the Bispectral index monitoring
15729880|NCT05025371|Other|Systemic immune-inflammatory markers|Systemic immune-inflammatory markers used in this study: total neutrophil count, total lymphocyte count, total monocyte count, total platelet count, neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), lymphocyte-to-monocyte ratio (LMR), systemic immune-inflammation index (SII), prognostic nutritional index (PNI)
15729881|NCT05025358|Drug|LP-118 tablet|Subjects will administered orally with LP-118 tablet at the designated dose once daily, using approximately 240 mL of water during a meal or within 30 minutes after a meal, 28 days per cycle. The treatment will continue until progressive disease, unacceptable toxicity, etc.
15729882|NCT05025345|Device|Tecnis Eyhance|Investigational intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
15729883|NCT05025345|Device|Tecnis 1 piece IOL|Control intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
15729884|NCT05025332|Drug|NNZ-2591|NNZ-2591 oral solution (50mg/mL) to be administered twice daily at a weight-banded dose for 13 weeks.
15729885|NCT05025319|Radiation|X-ray image|Bedside x-ray at intensive unit.
15729886|NCT05025306|Drug|ziziphus honey|ziziphus honey obtained form ziziphus spina-christi trees also called sidr tree
15729887|NCT05025293|Drug|Zoledronic Acid 5Mg/Bag 100Ml Inj|100ml Zoledronic acid (5mg/100ml) administered intravenously
15729888|NCT05025293|Drug|sodium chloride|100ml NaCl 9mg/ml administered intravenously
15729891|NCT05025254|Other|Neurocognitive testing|"We are assessing several cognitive domains and have made minor adaptations (reducing the total number of trials or lengthening response windows) to several standard neuropsychology tests including measures of executive function, working memory, visuospatial function, declarative memory, reward processing, response inhibition.
~Overall, the tests we use follow a standard set-up: participants are shown stimuli on the screen and are asked to provide a response using either a keyboard or a mouse, based on a specific set of instructions. We always provide a detailed set of on-screen instructions and a practice phase. In some cases, information about performance is provided in the form of points, in other cases, none is provided."
15729892|NCT05025241|Drug|NNZ-2591|NNZ-2591 oral solution (50mg/mL) to be administered twice daily at a weight-banded dose for 13 weeks.
15729893|NCT05025228|Drug|Paracetamol|Paracetamol given orally or intravenously
15729894|NCT05025215|Behavioral|Precise Aerosol Inhalation Nursing Program|The precise aerosol inhalation nursing program was based on the traditional oxygen aerosol inhalation treatment, including precise body position care, time control, observation and treatment, evaluation, etc.
15729895|NCT05025215|Behavioral|Traditional Aerosol Inhalation Nursing Method|The traditional aerosol inhalation nursing method is carried out according to the operation of aerosol inhalation.
15729896|NCT05025202|Other|Isometric exercise training|A form of exercise involving static contraction against a wall, sustained for 2 minutes x4 sets per session. 3 sessions a week were required. The intensity was designed to achieve 95% of the participants maximum heart rate.
15729897|NCT05025189|Other|Table Grape Powder|Freeze Dried Whole Table Grape Powder
15729898|NCT05025189|Other|Beige Diet|Low Fiber, low polyphenol Diet
15729899|NCT05025176|Device|Non invasive arterial pressure monitoring|Non invasive arterial pressure monitoring
15729900|NCT05025163|Drug|1.23% fluoride foam application|topical application of fluoride foam every 6 months
15729901|NCT05025163|Drug|2.26% fluoride varnish application|topical application of fluoride varnish every 6 months
15729902|NCT05025137|Other|Flexi-Bar Exercise|"In the experimental group, the Flexi-Bar was adopted as the tool for active vibration exercises. Featuring light weight and ease of operation, it weighs only 460 grams and has a vibration frequency of 4-5 Hz. With diversified functions, the Flexi-Bar can improve posture, burn fat, strengthen connective tissue, enhance body shape, and increase muscle strength.
~The 12-week Flexi-Bar exercise course in this study was created by two assistant professors specializing in rehabilitation (one with an occupational therapy certificate and the other with a physical therapy certificate). The course, composed of one 60-minute class per week for a total of 12 weeks, progressed gradually from basic activities (e.g., standing with both feet) to advanced activities (e.g., standing with one foot)."
15729903|NCT05025137|Other|Multi-Component exercise|Alternatively, in the control group, the Multi-Component exercise was adopted, which included aerobic, resistance, flexibility, and balance exercises. The course was composed of one 60-minute class per week for a total of 12 weeks. The design was based on the ACSM's recommendations for the multiple-component exercise of the elderly (Chodzko-Zajko et al., 2009) and videos of the National Health Exercises for the Elderly formulated by the Ministry of Health and Welfare (Ministry of Health and Welfare, 2017). The course was created and led by a physical therapist to gradually progress from sitting postures to standing and walking postures. Additionally, the intensity of the exercises was adjusted according to the participants' physical conditions; fitness equipment was introduced when appropriate.
15729904|NCT05025124|Device|Entia Liberty|Home monitoring system
15729905|NCT05025111|Device|Entia Liberty|Home monitoring device
15729995|NCT05024500|Other|Electrical Impedance Tomography|The setting of the PEEP level above the intersection of the curves representing relative alveolar overdistention and collapse, after a modified alveolar recruitment maneuver.
15730122|NCT05023577|Drug|Clarithromycin|0.5g bid
15729906|NCT05025098|Drug|Standard therapy|"For AML patients: Venetoclax will be administered orally once daily Days 1 through 28, of a 28-day cycle, with a designated dose of 400 mg daily after ramp up in Cycle 1. During Cycle 1 Days 1 - 3, the dose of Venetoclax will ramp up from 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Day 3. Azacitidine (100 mg/m2) is given once daily following administration of venetoclax for 5 days of every cycle, starting on Day 1 of each cycle.
~For MDS patients: Azacitidine (100 mg/m2) is given once daily for 5 days of every 28 day cycle, starting on day 1 of each cycle."
15729907|NCT05025098|Drug|Precision therapy|Precision therapy for both AML and MDS patients is standard therapy + tumor board determined precision therapy. The tumor board determined precision therapy can be all available drugs with a marketing authorization in Norway.
15729910|NCT05025072|Drug|Hydroxycarbamide dispersible tablets|Hydroxycarbamide dispersible tablets (20 x 50 mg)
15729911|NCT05025072|Drug|Hydroxycarbamide film-coated tablet|Hydroxycarbamide film-coated tablet (1000 mg)
15729912|NCT05025059|Procedure|Discussion|Participate in coaching sessions
15729913|NCT05025059|Other|Exercise Intervention|Perform walking exercise
15729914|NCT05025059|Other|Exercise Intervention|Perform strength exercises
15729915|NCT05025059|Other|Informational Intervention|Receive WWE workbook and Growing Stronger Strength Training Program instruction manual
15729916|NCT05025059|Other|Informational Intervention|Maintain exercise log
15729917|NCT05025059|Other|Medical Device Usage and Evaluation|Wear fitness tracker
15729918|NCT05025059|Other|Quality-of-Life Assessment|Complete questionnaires
15729919|NCT05025059|Other|Questionnaire Administration|Complete questionnaires
15729920|NCT05025046|Diagnostic Test|Thyroscan|To evaluate the accuracy of Thyroscan in the differential diagnosis of benign and malignant thyroid nudules with abnormal ultrasound features.
15729921|NCT05025033|Drug|PD-1 antibody, paclitaxel or irinotecan, Apatinib mesylate|PD-1 antibody 200mg intravenous drip every 3 weeks; Apatinib 250mg/day; Chemotherapy: Irinotecan 150mg/m2, intravenous drip every 2 weeks, or Paclitaxel 150mg/m2, intravenous drip, once every 3 weeks.
15729922|NCT05025020|Other|interactive 3D tool|The study tool displays 3-dimensional step-by-step animations of autologous and implant-based breast reconstruction procedures.
15729923|NCT05025020|Other|BREAST-Q Reconstruction Module|The BREAST-Q Reconstruction Module1-3 has 6 domains that cover various aspects of patient satisfaction and quality of life. BREAST-Q is part of our standard of care for patients treated for breast cancer and referred for reconstruction.
15729924|NCT05025020|Other|DQI|The DQI has 3 domains that cover decision-specific questions about what it is like for a patient to make decisions about reconstruction after breast cancer treatment.
15729925|NCT05025020|Other|Ottawa Decision Regret Scale|The validated Decision Regret Scale measures distress or remorse after a health care decision by the use of 5 items to indicate the extent to which the respondent agrees or disagrees with the statements in the regret scale.
15729926|NCT05024994|Drug|E7820|100mg of E7820 QD
15729927|NCT05024981|Behavioral|Videographic feedback|Twice a week during his classic re-education sessions, the patient will be filmed for 1 minute. After transferring the video to a tablet, he will watch the video once and decide what he wants to correct. During the second viewing, he will analyse his walk, the therapist being present to provide additional information. Finally, the patient will apply his analysis while being filmed and will compare the possible differences between the 2 videos. Depending on the time available, the patient may have to repeat the recordings, analyses and exercises.
15729928|NCT05024981|Behavioral|Classic reeducation|The patient will benefit twice a day for 30 minutes from re-education sessions.
15729929|NCT05024968|Drug|Sintilimab|Given by IV
15729930|NCT05024955|Procedure|Discussion|Attend a focus group
15729931|NCT05024955|Other|Interview|Attend interview
15729932|NCT05024942|Procedure|Transfemoral TAVR (Transcatheter aortic valve replacement)|Transfemoral transcatheter aortic valve replacement (TAVR) is a minimally invasive heart procedure to replace a narrowed aortic valve that fails to open properly (aortic valve stenosis) through an incision in the groin. All FDA approved transcatheter aortic prosthesys are allowed.
15729933|NCT05024929|Procedure|Whole body scan|"Patients will receive oncogene-specific molecularly targeted therapy independently of this protocol either via commercial supply of an FDA approved agent, or as part of a separate therapeutic clinical trial/compassionate use protocol/single patient investigational new drug (IND).
~During screening, patients will undergo a baseline RAI-whole body scan (WBS) to assess RAI-avidity of their tumor per standard of care. Following approximately 1 week of targeted therapy, the WBS will be repeated to determine whether this therapy is associated with an increase in RAI-avidity of their tumor."
15729934|NCT05024916|Dietary Supplement|Intervention|26 g packets of freeze-dried blueberries (equivalent to 1 cup of fresh blueberries) will be given to participants to be consumed daily. Participants will be asked to consume 1 packet per day for 3 months.
15729935|NCT05024916|Dietary Supplement|Control|26 g packets of isocaloric carbohydrate-matched powder will be given to participants to be consumed daily. Participants will be asked to consume 1 packet/day for 3 months.
15729936|NCT05024903|Other|Serious illness medical planning plus the novel e-health platform (PWG 2.0)|"PWG 2.0 consists of the following components:
~A diagnostic questionnaire, Preparedness for the Future Questionnaire and bench-marked report that helps users assess their strengths, weaknesses and opportunities for improvement.
~A comprehensive e-workbook that helps users understand the science behind personal behavior change.
~Links to webpages with additional e-workbooks and curated content aimed to help users progress on the 30 different attitudes, behaviors, and activities that portend for a better future (topics listed in Appendix A).
~E-messages delivered via emails (via text an option for those that prefer) with tailored content designed to provide multiple nudges to guide the user to progress through our content.
~Monthly newsletter with current topics and issues related to the 30 topics and behavior change in general.
~A virtual consultation with Dr. Heyland, creator of PWG and principal investigator."
15729937|NCT05024903|Other|Standard of care|Participants are not planning for their future (PWG 2.0) or using the e-health platform
15729996|NCT05024487|Diagnostic Test|Clinical Examination|Given the most frequent causes of AD, the above-mentioned trigger stimuli will be used. All these procedures are commonly used in SCI people.
15729938|NCT05024890|Other|Splash WASH in Schools programme (Project WISE)|"The Project WISE intervention includes:
~WASH infrastructure
~Water storage tanks and water filtration systems
~Durable plastic drinking water and handwashing stations
~New/rehabilitated toilet facilities (gender-segregated, wheelchair-accessible, well-lit, ventilated, durable door and lock)
~Behaviour change promotion
~Training of focal teachers to organise student 'hygiene club'
~Annual soap drive and soap restocking
~Behavioural 'nudges' (posters and mirrors at handwashing stations, colourful vests for hygiene clubs)
~MHM services
~Toilets have water tap, bucket and waste bin
~Emergency menstrual hygiene products available at school
~Training of focal teachers to organise student 'gender club'
~Education on puberty and menstruation for all pupils above 10 and parent resource guide"
15729939|NCT05024877|Drug|Hetrombopag|Hetrombopag would be given started with 5mg/day and increased by 2.5mg/day every 2 weeks if the platelet count remains less than 20×10e9/L and reduced if the platelet count reaches over than 150×10e9/L, the maximum dosage is 15mg/day)
15729940|NCT05024877|Drug|Stanozolol Tablets|Stanozolol would be given 2mg tid.
15729941|NCT05024864|Diagnostic Test|Urea breath test|"After fasting for six hours prior to testing, the patient swallows a C13 Urea tablet or solution and waits. After 10 minutes, the patient exhales and breath is collected (breath bag). The production of 13CO2 is measured by a desktop analyzer (infrared mass spectrometry) and active H. pylori infection diagnosis is made based on previously established cut-off levels for H. pylori infection. In patients tested positive, eradication therapy according to the national society of gastroenterology guidelines will be prescribed at the caring physician's discretion.
~Control of successful H. pylori eradication 6 weeks after completed eradication therapy is recommended to the treating physician."
15729942|NCT05024851|Other|Questionnaires|Evaluation of the Psychogenic and Neurogenic Components using questionnaires
15729943|NCT05024838|Other|Machine learning methods|This is an observational study of the retrospective collection of patient data. Anesthesia-related factors such as anesthesiologist's expertise, injection site, patient position, the dosage of local anesthetics, needle size, the direction of needle bevel, and basic demographic information of the patients were used for data analysis. Patients less than 18 years old were excluded from this study. Twenty percent of the dataset was used as a testing dataset, and the remaining were used for model training. The investigators will utilize four machine learning algorithms as XGBoost (Extreme Gradient Boosting), AdaBoost (Adaptive Boosting), Random Forest (RF), and support vector machine (SVM). Model performances were evaluated visually with a confusion matrix.
15729944|NCT05024825|Drug|Gabapentin|Patients in the gabapentin arm may at any point call the Pediatric ENT clinic if pain is not adequately controlled. Patients will be prescribed hydrocodone acetaminophen solution 7.5mg-325mg/15mL 5mL for ages 12-14 yrs and 10 mL for ages 15-18yrs, q 4-6 hours as needed for pain. Patients will be informed to stop taking gabapentin.
15729945|NCT05024825|Drug|hydrocodone, acetaminophen and ibuprofen|Patients in the hydrocodone group will receive scheduled doses of hydrocodone, acetaminophen and ibuprofen at scheduled doses. Acetaminophen 15mg/kg (max 1 gm) every 4-6 hours as needed for pain, max dose 4 gm per day; Ibuprofen 4-10 mg/kg PO divided over 8 hours as needed for pain, max dose 40 mg/kg/day; hydrocodone acetaminophen solution 7.5mg-325mg/15mL 5mL for ages 12-14yrs and 10 mL for ages 15-18yrs, q 4-6 hours as needed for pain.
15729946|NCT05024812|Drug|fruquintinib＋toripalimab + SOX|phase Ib: fruquintinib (dose finding): L1: 3 mg/d，L2: 4 mg/d，L3: 5 mg/d, qd po, D1-14, Q3W toripalimab: 240mg, I.V., D1, Q3W; S-1: 40-60mg bid, D1-14, Q3W; Oxaliplatin: 130mg/m^2, ivgtt 2h, D1,Q3W. phase II: fruquintinib: RP2D toripalimab: 240mg, I.V., D1, Q3W; S-1: 40-60mg bid, D1-14, Q3W; Oxaliplatin: 130mg/m^2, ivgtt 2h, D1,Q3W.
15729947|NCT05024799|Drug|Fentanyl, propofol|The patients in this group will be administered with fentanyl and propofol
15729948|NCT05024799|Drug|fentanyl and dexmedetomindine|The patients in this group will be administered with fentanyl and dexmedetomindine
15729949|NCT05024799|Drug|Butorphanol and propofol|The patients in this group will be administered with butorphanol and propofol
15729950|NCT05024799|Drug|Butorphanol and dexmedetomindine|The patients in this group will be administered with butorphanol and dexmedetomindine
15729951|NCT05024786|Other|continuous quality improvements|We implement the continuous quality improvement strategy in CQI group, and observe the effect of the strategy on the mortality of patients supported with ECMO .
15729952|NCT05024773|Drug|ONCOFID P-B (PACLITAXEL-HYALURONIC ACID)|Schedule: once a week for 12 consecutive weeks (induction therapy). Patients who achieve a complete response at the end of the induction phase will enter the maintenance phase, during which ONCOFID-P-B is administered once a month for 12 months until recurrence or progression of the disease.
15729953|NCT05024760|Drug|Chlorhexidine|Chlorhexidine will be inserted into the dental implant internal cavity during dental implant insertion.
15729954|NCT05024760|Drug|Hydrogen Peroxide|Hydrogen Peroxide will be inserted into the internal cavity of the dental implant during dental implant insertion.
15729955|NCT05024747|Drug|NicoDerm CQ patch (GSK Dungarvan)|A single patch of a NicoDerm CQ (GSK Dungarvan) 21 mg per system of 22 centimeter square (cm^2) surface area will be placed topically.
15729956|NCT05024747|Drug|NicoDerm CQ (Alza)|A single patch of a NicoDerm CQ (Alza) 21 mg/system of 22 cm^2 surface area will be placed topically.
15729957|NCT05024734|Drug|Epirubicin|"In PDOs from patients that show highest response to Epirubicin, this drug will be instilled intravesically once weekly for 6 times.
~Epirubicin is also the default drug, in case of failure of drug prediction in the in-vitro drug screen in PDO.
~Epirubicin will be used as a concentrate for injection/instillation 2 mg/ml in total 50mg per vial. Prior to use, the concentrate for injection is diluted with 25ml of 0.9% saline solution to obtain the final Solution with 1mg/ml of Epirubicin."
15729958|NCT05024734|Drug|Mitomycin|"In PDOs from patients that show highest response to Mitomycin, this drug will be instilled intravesically once weekly for 6 times.
~Mitomycin C will be used as 20mg dry powder. Prior to use, the powder will be dissolved in 50ml of 0.9% saline solution according to the manufacturer instructions"
15729959|NCT05024734|Drug|Gemcitabine|"In PDOs from patients that show highest response to Gemcitabine, this drug will be instilled intravesically once weekly for 6 times.
~Gemcitabine will be used as 2000 mg/50ml. For intravesical application, 1000mg of gemcitabine (corresponding to 25ml) will be diluted in 25ml 0.9% saline solution, to obtain the gemcitabine concentration of 1000mg/50ml used for instillation."
15729997|NCT05024474|Other|Inspiratory muscle training (IMT)|Inspiratory muscle training (IMT) at 20-50 % of maximal inspiratory pressure (MIP), 2 x 30 repetitions, twice a day for 8 weeks.
15729960|NCT05024734|Drug|Docetaxel|"In PDOs from patients that show highest response to Docetaxel, this drug will be instilled intravesically once weekly for 6 times.
~Docetaxel will be used as 140mg/7ml solution. For intravesical application, 48.825ml of saline will be added to 1.875ml Docetaxel solution (according 37.5mg of Docetaxel). The concentration of this solution is 0.74mg/ml by a total volume of the instillation solution of 50,7."
15729961|NCT05024721|Drug|HIP2101|Test drug
15729962|NCT05024721|Drug|RLD2101|Reference drug
15729963|NCT05024721|Drug|HPP2101|Placebo drug
15729964|NCT05024721|Drug|HPP2102|Placebo drug
15729965|NCT05024708|Other|Cardiac exercises and tests|Rest ECG, rest echocardiography, cardio-pulmonary exercise test, exercise echocardiography, holter ECG monitor (48 yours), rest CMR, exercise CMR (ergocycle)
15729966|NCT05024695|Device|MINIject™ Implant|The MINIject™ SO627 is an integrated system for Minimally Invasive Glaucoma Surgery (MIGS) comprised of a glaucoma drainage implant, the MINIject™ SO627 and the SO Delivery System, designed to deliver the MINIject™ implant into the supraciliary space.
15729967|NCT05024682|Device|conventional pulsed radiofrequency|After connecting the electrode and the PRF needle, the interventionist determined whether the pudendal nerve innervation produced paresthesia in the sensory stimulation test with a frequency of 50 Hz, pulse width of 1 ms and a voltage of 0.3-0.5 V. Thereafter, the radiofrequency ablation therapy was performed in 42°C, 120 seconds pulse mode which consisted of four cycles (8 minutes)
15729968|NCT05024682|Device|pulse dosed pulsed radiofrequency|After connecting the electrode and the PRF needle, the interventionist determined whether the pudendal nerve innervation produced paresthesia in the sensory stimulation test with a frequency of 50 Hz, pulse width of 1 ms and a voltage of 0.3-0.5 V. Thereafter, the radiofrequency ablation therapy was performed in 42°C, 240 seconds pulse dose mode which consisted of two cycles (8 minutes).
15729969|NCT05024669|Combination Product|Gluma desensitiser|Gluma desensitiser was used before restoration.
15729970|NCT05024669|Combination Product|Sheildforce Plus desensitiser|Sheildforce Plus desensitiser was used before restoration.
15729971|NCT05024669|Combination Product|Telio CS desensitiser|Telio CS desensitiser was used before restoration.
15729972|NCT05024656|Other|AmnioExcel Plus Amniotic Membrane|AmnioExcel® Plus will be applied weekly, in conjunction with SOC, if the ulcer remains open, or up to and including Week 11, whichever comes first.
15729973|NCT05024656|Other|Standard of Care|The dressings, materials, and appliances used in accordance with institutional protocol or professional clinical judgement.
15729974|NCT05024643|Procedure|Endonasal endoscopy|"Complete sphenoethmoidectomy; Draf type IIa, IIb, and III according to defect location.
~Defect less than 3 mm closed by a plug of fat and facia lata or middle turbinate mucosa.
~Defect more than 3 mm closed by underlying facia lata, underlying cartilage, and overlay facia lata."
15729975|NCT05024630|Procedure|Renal artery cryoablation|Renal denervation were achieved by cryoablation of renal artery with cryoballoon.
15729976|NCT05024630|Procedure|Pulmonary vein cryoablation|Pulmonary vein isolation was achieved by cryoablation of pulmonary veins with cryoballoon.
15729977|NCT05024630|Procedure|Renal arteriography|Renal artery was examined by renal arteriography
15729978|NCT05024617|Other|conservative treatment|All patients had rehabilitation for a total of three months, including activity modification, splinting and exercises.
15729979|NCT05024604|Drug|Progesterone Only Product in Oral Dose Form|mini pills as a contraceptive method
15729980|NCT05024604|Other|office hysterscopy|office hysteroscoy
15729981|NCT05024591|Device|Lunit INSIGHT MMG CADe/x for medical imaging|• A software that detects areas suspected of breast cancer using mammographic images, marks areas suspected of malignant lesions, and displays the probability of malignant lesions to assist with the interpreting physician's diagnosis
15729982|NCT05024578|Device|DREEM2|Closed-loop EEG monitoring and auditory stimulation in which 100ms pulses of pink noise are delivered on the ascending phase of slow oscillations during N3 sleep.
15729983|NCT05024578|Device|Placebo|EEG monitoring with the same headband as in the DREEM2 intervention, but without any sound stimulation.
15729984|NCT05024565|Behavioral|prolonged intravenous infusion of β-lactams Antibiotics|(1) Carbapenems: Calculate the daily dose according to the creatinine clearance rate and divide it into 3 times. Each time, the dose is injected intravenously at 1/2 dose for 15 minutes, and the remaining 1/2 dose is injected at a constant rate for 3 hours. (2) Cephalosporins: calculate the allowable daily dose according to the creatinine clearance rate, inject at a uniform rate within 24 hours. (3) β-lactams and β-lactamase inhibitor compound: the daily dose is calculated according to the creatinine clearance rate and injected at a uniform rate within 24 hours.
15729985|NCT05024552|Drug|Gilteritinib|Gilteritinib is an oral inhibitor of FLT3-ITD and FLT3-TKD. Dose cohort 1 will receive 120mg daily on days 6-19 of induction and days 4-17 of re-induction and consolidation
15729986|NCT05024552|Drug|Vyxeos|Vyxeos is a liposomal encapsulation of cytarabine and daunorubicin. It is given as an intravenous infusion over 90 minutes on days 1, 3 and 5 of induction and days 1 and 3 of re-induction and consolidation. The induction and reinduction dose is 44mg/m2 daunorubicin and 100mg/m2 of cytarabine with each infusion. The consolidation dose is 29mg/m2 daunorubicin and 65mg/m2 of cytarabine with each dose.
15729987|NCT05024539|Other|nonintervention|
15729988|NCT05024526|Drug|edaravone dexborneol or edaravone|Edaravone dexborneol or edaravone is going to be used in two different groups to compare the efficacy.
15729989|NCT05024513|Drug|oxaliplatin and 5-fluorouracil|Intra-arterial chemotherapy consisted of Oxaliplatin (40mg/m2 for 2 hours), 5-fluorouracil (800 mg/ m2 for22 hours) on days 1-3 every 4 weeks.
15729990|NCT05024513|Procedure|Biliary Drainage|External biliary drainage, or biliary stent placement; Biliary stent placement plus Iodine-125 seed strands is allowed
15729991|NCT05024513|Other|Best Supportive Care|Nutrition support, symptomatic treatment, and other supportive treatments
15729992|NCT05024513|Procedure|External biliary drainage|External biliary drainage
15729993|NCT05024500|Other|ARDSNet table|The setting of the lowest PEEP level and FiO2 match stated by the table to achieve a goal oxygenation.
15729994|NCT05024500|Other|Driving Pressure|The setting of the lowest PEEP level by the lowest correspondent driving pressure, which is defined by the difference of plateau pressure, after a modified alveolar recruitment maneuver.
15729998|NCT05024474|Other|Physical exercise|A physical exercise program at least two times a week for 8 weeks. Including strength, aerobic and mobility exercises.
15729999|NCT05024461|Diagnostic Test|Salivary test for COVID19|"Results of nasopharyngeal and salivary samples taken at the Cayenne hospital and the Caen university center,
~Pre-analytical particularities and analytical particularities
~Cycle threeshold
~Demographic variables
~Clinical variables
~Clinical criteria
~Questionnaire on the perception of the 2 sampling methods"
15730000|NCT05024448|Drug|Prednisone|oral administration, 60mg/d for 10d
15730001|NCT05024435|Device|Surfactant Administration|Laryngoscopy, intratracheal catheter placement and surfactant administration
15730002|NCT05024422|Drug|Cabergoline|Administration of Cabergoline (one dose of 1mg, up to 24 hours postpartum, or 0.25 mg twice a day for two days)
15730003|NCT05024422|Drug|Pyridoxine|Administration of Pyridoxine (200 mg X 3 per day for a week)
15730004|NCT05024409|Device|Upper Extremity Orthotic|3D printed orthotic which uses elbow motion to facilitate finger extension
15730005|NCT05024409|Other|Occupational Therapy|6 weekly sessions of occupational therapy, without use of an assistive orthotic device
15730006|NCT05024396|Diagnostic Test|maximum jump height|Three single leg countermovement jumps were performed. The maximum jump height is measured with a sensor that is adapted at the subjects'leg and with a force plate.
15730007|NCT05024383|Other|Chemical sensitivity|Chemical sensitivity will be evaluated with paper taste strips embedded with varying concentrations of capsaicin solutions (activates TRPV1) and allyl isothiocyanate solutions (activates TRPA1) applied to the tongues of healthy subjects and site of cancer in oral cancer patients.
15730008|NCT05024383|Other|Mechanical sensitivity|Mechanical sensitivity will be evaluated via von Frey filaments applied to the tongues of healthy subjects and and site of cancer in oral cancer patients.
15730009|NCT05024357|Drug|Dasatinib|Take Dasatinib orally for 1 year or 6 months post-HSCT.
15730010|NCT05024344|Procedure|Erector Spinae Plane Block|The Anesthesiologist will use ultrasound-guided technique and inject 30mL of 0.5% ropivacaine with 4 mg of dexamethasone or saline placebo control into the erector spinae muscle, superficial to the tips of the thoracic transverse processes
15730011|NCT05024344|Drug|Ropivacaine 0.5% Injectable Solution|The Anesthesiologist will use ultrasound-guided technique and inject 30mL of 0.5% ropivacaine with 4 mg of dexamethasone or saline placebo control into the erector spinae muscle, superficial to the tips of the thoracic transverse processes
15730012|NCT05024344|Drug|Dexamethasone|The Anesthesiologist will use ultrasound-guided technique and inject 30mL of 0.5% ropivacaine with 4 mg of dexamethasone or saline placebo control into the erector spinae muscle, superficial to the tips of the thoracic transverse processes
15730013|NCT05024318|Drug|Pembrolizumab|Pembrolizumab 200 mg tobe administered as a 30 minute IV infusion every 21 days for 3 cycles
15730014|NCT05024318|Radiation|Stereotactic Ablative Radiotherapy|42Gy delivered in 3 fractions
15730015|NCT05024318|Procedure|Nephrectomy|Partial or total nephrectomy performed 9-12 weeks after first dose of Pembrolizumab
15730016|NCT05024305|Drug|TWP-102 injection|IV infusion
15730017|NCT05024279|Device|Left bundle branch area pacing|"Left bundle branch area pacing will be applied as established in the literature using commercially available equipment.
~In case of unsuccessful application of left bundle branch area pacing, cross-over to right ventricular pacing is allowed."
15730018|NCT05024279|Device|Right ventricular pacing|Right ventricular pacing as the standard, established form of pacing will be applied in the control group. No cross-over to the intervention arm is anticipated.
15730019|NCT05024266|Drug|Tislelizumab|Participants received 2 cycles Tislelizumab 200mg d1 + Albumin Paclitaxel 260mg/m2 d1 + Carboplatin AUC5 d1 every 3 weeks, and then were evaluated for surgery.
15730020|NCT05024253|Drug|Tranexamic acid injection|. TXA, a lysine analogue, reversibly binds to the plasminogen lysine receptors and thereby blocks plasminogen from binding to fibrin (tPA can only activate fibrin-bound plasminogen and produce plasmin responsible for cleaving fibrin molecule and dissolving the blood clot)
15730021|NCT05024253|Drug|Saline|mixture of sodium chloride (salt) and water in solution with 0.90% w/v of NaCl
15730022|NCT05024240|Diagnostic Test|Stabilometry|Probands will stand on stabilometric platform (double leg stance) and we will measure CoP parameters area and length. We also make this task harder by using foam and exclusion of visual control. Length of one test is 30s.
15730023|NCT05024240|Diagnostic Test|Stroop test|There are various names of colours written in non-matching font colour in this test. During this test probands are required to name the colour which is written in text not the colour of the font. We will measure reaction time and number of mistakes.
15730024|NCT05024240|Diagnostic Test|Backward counting test|In this counting test probands are given number from interval <180-200> and they are asked to subtract 7 during 30s interval of the testing. We will measure reaction time and number of mistakes.
15730025|NCT05024227|Behavioral|Experimental: nursing education interventions (including e-health platform assistance)|Nursing education intervention: Researchers use teaching, consultation and other methods to give individual cases planned learning to meet individual needs, providing 1. What is an environmental hormone-plasticizer; 2. Common types of environmental hormones (such as plasticizers) and Uses 3. Environmental hormones-sources of plasticizers 4. Environmental hormones-plasticizers harm to the human body 5. How to avoid the common environmental hormones-plasticizers and other related health education in life, and use the electronic platform to assist nursing education conduct.
15730028|NCT05024201|Behavioral|THERAPEUTİC TOUCH FOR HEMODİALYSİS PATİENTS|Therapeutic touch was applied to hemodialysis patients for 3 days every other day.
15730029|NCT05024188|Drug|Antibiotics|Ciprofloxacin, 500 mg 2/day & Metronidazole (Flagyl), 500 mg 3/day.
15730030|NCT05024188|Other|Fecal Microbiota Transplantation|Fecal Microbiota Transplantation is the process of transferring stool from a healthy donor to another.
15730031|NCT05024188|Other|Cellules Pills|7 days of cellules placebo pills.
15730032|NCT05024188|Other|Agarose Capsules|Placebo capsules consist a combination of agarose in normal saline/glycerol (the same vehicle as in a FMT capsules)
15730033|NCT05024175|Diagnostic Test|Disease assessments|CT (Computerized Tomography) scan or PET-CT (Positron Emission Tomography-Computerized Tomography) scans as per protocol
15730034|NCT05024175|Procedure|Tumor Biopsy|Tumor Biopsy per protocol
15730035|NCT05024175|Diagnostic Test|Blood test|Blood Test per protocol
15730036|NCT05024162|Diagnostic Test|MRT Accuracy|Predicted Grade Group (GG) by the MRI-based Radiomics Tool (MRT) at each Magnetic Resonance Imaging of the Prostate (MRI-P)
15730037|NCT05024162|Diagnostic Test|MRT Stability|MRT's predicted GG at second MRI-P.
15730038|NCT05024149|Other|infrared thermography (IRT)|The temperature and infrared thermography (IRT) images of the facial acupoints of three groups will be recorded by an infrared thermal-imaging camera.
15730039|NCT05024136|Device|Limon essential oil aromatherapy|Subjects receive three times 30 mins aromatherapy of Limon essential oil per time for the month. Anthropometric measurements such as blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), autonomic nerve parameters including a. SDNN (standard deviation of all normal to normal intervals index); b. HRV（heart rate variability）; c. LF（0.04-0.15 Hz）and HF（0.15-0.4 Hz）were measured every week. PSQI（Pittsburgh sleep quality index）and HADS (Hospital Anxiety and Depression Scale) were measured initial and ten ends.
15730040|NCT05024136|Device|Vetiver essential oil aromatherapy|Subjects receive three times 30 mins aromatherapy of vetiver essential oil per time for the month. Anthropometric measurements such as blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), autonomic nerve parameters including a. SDNN (standard deviation of all normal to normal intervals index); b. HRV（heart rate variability）; c. LF（0.04-0.15 Hz）and HF（0.15-0.4 Hz）were measured every week. PSQI（Pittsburgh sleep quality index）and HADS (Hospital Anxiety and Depression Scale) were measured initial and ten ends.
15730041|NCT05024123|Dietary Supplement|Placebo|"Before each study day, the participants were subjected to a reduced nitrate content diet (avoid foods such as dark chocolate, beets, garlic, nuts and seeds, bacon, ham, and hot dogs,, day-1) for 24h. All subjects took a 50 mg placebo (maltodextrin) capsule at 9 p.m. and began fasting for 12 hours, except for a small amount of water in the night before the experiment. On each study day, all subjects collected their first blood sample at 9 a.m. from the median cubital vein using the indwelling catheter method. After the first blood collection, all subjects took 50 mg placebo and 5 g of L-arginine with 250 mL water.
~Additional blood samples were collected at 0, 15, 30, 45, 60, 90, 120, 150, and 180 min for analysis of the plasma concentration of amino acids, total nitrite, nitrate, and asymmetric dimethylarginine (ADMA) content.
~All subjects collected their urine during 0 ~ 180 min to measure 1) nitrate and 2) cGMP content."
15730042|NCT05024123|Dietary Supplement|AstraGin|"Before each study day, the participants were subjected to a reduced nitrate content diet (avoid foods such as dark chocolate, beets, garlic, nuts and seeds, bacon, ham, and hot dogs,, day-1) for 24h. All subjects took a 50 mg placebo (maltodextrin) capsule at 9 p.m. and began fasting for 12 hours, except for a small amount of water in the night before the experiment. On each study day, all subjects collected their first blood sample at 9 a.m. from the median cubital vein using the indwelling catheter method. After the first blood collection, all subjects took 50 mg placebo and 5 g of L-arginine with 250 mL water.
~Additional blood samples were collected at 0, 15, 30, 45, 60, 90, 120, 150, and 180 min for analysis of the plasma concentration of amino acids, total nitrite, nitrate, and asymmetric dimethylarginine (ADMA) content.
~All subjects collected their urine during 0 ~ 180 min to measure 1) nitrate and 2) cGMP content."
15730043|NCT05024110|Other|High intensity treamill exercise training.|We used the Martti Karvonen formula to calculate the heart rate zone. Firstly, the resting heart rate (rest-HR) was detected for every participant by inviting him to lie in a prone position for 10 minutes while catching a heart rate monitor. After that, the maximum heart rate (max-HR) was calculated by utilizing this formula: maximum heart rate =220- age. Then, we calculated the heart rate reserve (HRR) by using the law: HRR= max-HR - resting HR. Exercise intensity is represented as a percentage of HRR. Finally, the target heart rate (target-HR) was calculated by using the formula: target-HR = HRR x intensity% + rest-HR. Moderate-intensity exercises are defined as the activity which uses 50% to 70% of the HRR, while high-intensity exercises use 70% to 90% of the HRR
15730044|NCT05024110|Other|Moderate intensity treamill exercise training.|We used the Martti Karvonen formula to calculate the heart rate zone. Firstly, the resting heart rate (rest-HR) was detected for every participant by inviting him to lie in a prone position for 10 minutes while catching a heart rate monitor. After that, the maximum heart rate (max-HR) was calculated by utilizing this formula: maximum heart rate =220- age. Then, we calculated the heart rate reserve (HRR) by using the law: HRR= max-HR - resting HR. Exercise intensity is represented as a percentage of HRR. Finally, the target heart rate (target-HR) was calculated by using the formula: target-HR = HRR x intensity% + rest-HR. Moderate-intensity exercises are defined as the activity which uses 50% to 70% of the HRR, while high-intensity exercises use 70% to 90% of the HRR
15730045|NCT05024097|Drug|Etrumadenant (AB928)|Patients will receive a radiation therapy dose of 25Gy in 5 fractions in combination with etrumadenant 150 mg orally, once daily as part of a continuous dose regimen.
15730046|NCT05024097|Radiation|Radiation therapy|Patients will receive a radiation therapy dose of 25Gy in 5fx
15730047|NCT05024097|Drug|FOLFOX regimen|After completing the radiation therapy, patients will receive FOLFOX regimen for 9 cycles in combination with etrumadenant and zimberelimab. All patients will be offered adjuvant zimberelimab for up to one year.
15730048|NCT05024097|Drug|Zimberelimab (AB122)|After completing the radiation therapy, patients will receive FOLFOX regimen for 9 cycles in combination with etrumadenant and zimberelimab. All patients will be offered adjuvant zimberelimab for up to one year.
15730049|NCT05024084|Procedure|Minimal flow anesthesia (fresh gas flow <0.5 l/min) using Sevoflurane|Sevoflurane will be used for the maintenance of general anesthesia which will be carried out using a fresh gas flow of less than 0,5 l/min
15730050|NCT05024084|Procedure|Minimal flow anesthesia (fresh gas flow <0.5 l/min) using Desflurane|Desflurane will be used for the maintenance of general anesthesia which will be carried out using a fresh gas flow of less than 0,5 l/min
15730051|NCT05024071|Device|Wushu athletes in the experimental group used a Swiss ball for 12 weeks of core strength training|"The experimental group was given 12 weeks of core strength training, divided into 6 types
~Static action under steady state.
~No load movement in steady state.
~Static action under unstable state.
~Movement to overcome its own resistance in an unstable state.
~Free strength exercise in unstable state.
~Core explosive power exercise under unstable conditions."
15730123|NCT05023577|Drug|Levofloxacin|0.5g qd
15730052|NCT05024071|Device|Wushu athletes in the experimental group used a balance board for 12 weeks of core strength training|"The experimental group was given 12 weeks of core strength training, divided into 6 types
~Static action under steady state.
~No load movement in steady state.
~Static action under unstable state.
~Movement to overcome its own resistance in an unstable state.
~Free strength exercise in unstable state.
~Core explosive power exercise under unstable conditions."
15730053|NCT05024058|Drug|Ligelizumab|Ligelizumab treated groups and arms
15730054|NCT05024058|Other|Placebo|Placebo treated groups and arms
15730059|NCT05024019|Drug|Nimotuzumab|The study group received nimotuzumab (200mg, weekly, for 6 weeks) in combination with radiotherapy.
15730060|NCT05024006|Drug|Remdesivir|Two intravenous loading doses, then daily infusion for 10 days
15730061|NCT05024006|Drug|Hydroxychloroquine|Two oral loading doses, then orally twice daily for 10 days
15730062|NCT05024006|Drug|Lopinavir / Ritonavir|Orally twice daily for 14 days
15730063|NCT05024006|Drug|Interferon beta-1a|Daily injection for 6 days
15730064|NCT05024006|Drug|Acalabrutinib|Orally twice daily for 10 days
15730074|NCT05023954|Diagnostic Test|Blood test|Drop of blood for RNA and metabolic analysis
15730075|NCT05023941|Drug|Acetazolamide|Start orally take acetazolamide 125mg twice daily, 2 days before entering the hypoxic chamber. Subjects will enter the hypoxic room at 9am on the third day. At that time, the subject should have taken the drug 5 times.
15730076|NCT05023941|Device|Doctormate® (twice daily for 6 days)|Start RIPC training twice daily, 6 days before entering the hypoxic chamber. RIPC will be induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®). Each training will be comprised of 5 cycles of bilateral upper limb ischemia and reperfusion, which will be induced by 2 cuffs placed around the upper arms respectively and inflated to 200mmHg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. Subjects will enter the hypoxic room at 9am on the seventh day. At that time, the subject should have finished 13 times of RIPC training.
15730077|NCT05023941|Device|Doctormate® (forth daily for 3 days)|Start RIPC training forth daily, 3 days before entering the hypoxic chamber. RIPC will be induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®). Each training will be comprised of 5 cycles of bilateral upper limb ischemia and reperfusion, which will be induced by 2 cuffs placed around the upper arms respectively and inflated to 200mmHg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation. Subjects will enter the hypoxic room at 9am on the forth day. At that time, the subject should have finished 13 times of RIPC training.
15730078|NCT05023928|Biological|Tumor antigen-sensitized DC vaccine|subcutaneous administration
15730079|NCT05023915|Drug|dexamethasone|40 mg qd for 4 days
15730080|NCT05023915|Drug|diammonium glycyrrhizinate enteric-coated capsule|150mg tid for 3 months
15730081|NCT05023902|Other|Pilates|Pilates has been performed to all participants two times a week in order to compare the effects of NIA
15730082|NCT05023902|Other|Neuromuscular Integrative Action|NIA was the experimental group of this study.
15730083|NCT05023889|Drug|patisiran|"Patients will receive 0.3 mg/kg patisiran once every 21 days administered as an IV infusion over 70 minutes (approximately 1 mL/minute for the first 15 minutes followed by approximately 3 mL/minute for the remainder of the infusion) by a controlled infusion device.
~All patients in this study will be premedicated prior to dosing with patisiran. Study drug supplied for this study must not be used for any purpose other than the present study and must not be administered to any person not enrolled in the study.
~The first dose of study drug (week 1) will be administered under the supervision of site personnel. After the first dose of patisiran, patients should return to the site for patisiran dosing once every 21 days or receive the patisiran infusions at a local infusion center by a healthcare professional trained on the Protocol, administration of premedication, and patisiran infusion. Patient must receive a dose of interventional drug within the dosing window (±3 days)."
15730084|NCT05023876|Other|IASTM+respiratory Exercise|Instrument assisted soft tissue mobilization
15730085|NCT05023876|Other|Respiratory Exercise|Respiratory Exercise
15730086|NCT05023863|Drug|Alpha Lipoic Acid 600 MG Oral Tablets|Alpha Lipoic Acid (ALA) is a drug which has been used in treatment of diabetic neuropathy . It act through enhancing nitric oxide-mediated endothelium-dependent vasodilation, thus improving microcirculation in patients with diabetic polyneuropathy. It is considered a safe drug, generally with a daily dose of 200 to 2400 mg/day is considered tolerable without significant side effects. Only gastrointestinal tracts side effects like nausea, vomiting, dyspepsia and abdominal pain have been described in some clinical trials. Also FDA experts confirm its safety and efficacy in humans
15730087|NCT05023863|Other|Placebo tablets|placebo tablets of the same generic of active drug which contain all the same ingredients as active tablets except alpha lipoic acid
15730088|NCT05023863|Radiation|radiation or concurrent chemoradiation|radiation or concurrent radiotherapy plus platinum-based chemotherapy
15730089|NCT05023850|Procedure|TLIPB|Patients will receive TLIPB with an injection of 40 ml of bupivacaine 0.25% (2 injections of 20 ml on each side) between multifidus and longissimus muscles.
15730090|NCT05023850|Procedure|ESPB|Patients will receive ESPB with an injection of 40 ml of bupivacaine 0.25% (2 injections of 20 ml on each side) between erector spinae muscle and transverse process of a vertebra.
15730091|NCT05023837|Drug|Pembrolizumab 50 MG Injection|Pembrolizumab iv 200mg q21d
15730092|NCT05023824|Drug|alpha-blocker or 5-ARI withdrawal|Withdrawal of either alpha-blocker or 5-ARI
15730093|NCT05023824|Drug|Maintenance of alpha-blocker and 5-ARI|Maintenance of alpha-blocker and 5-ARI
15730094|NCT05023811|Drug|[14C]RIST4271|[14C]RIST4271 oral solution
15730096|NCT05023785|Behavioral|Cardio-oncology Rehabilitation (CORE)|Exercise therapy, CVD risk factor management for the first 6 months (as per current standards in CR models) and behavioural support for the entire 2-year intervention period
15730097|NCT05023785|Behavioral|PAI Group (PAI)|Participants in the PAI group will be asked to download the same PAI Health application as CORE participants and be challenged to meet and maintain a weekly PAI Score ≥100 throughout the 24-month follow-up period.
15730098|NCT05023785|Behavioral|Exercise Guidelines for Cancer Survivors (ExGL)|Participants in the ExGL group will be asked to download and use the Map My Walk (Under Armour, Baltimore) application and will be challenged to meet and maintain the updated weekly physical activity guidelines for cancer survivors (i.e. 90-150 minutes of moderate to vigorous-intensity physical activity).
15730099|NCT05023772|Procedure|Stereotactic Laser Ablation|MR Guided laser ablation therapy
15730100|NCT05023772|Radiation|Stereotactic Radiosurgery|Precise delivery of radiation to spinal tumor
15730101|NCT05023772|Diagnostic Test|MRI guided laser ablation|Surgery will take place in intraoperative suite to include operating room and MRI scanner
15730102|NCT05023759|Dietary Supplement|Formula30A Full Spectrum Hemp Cannabidiol 25mg Capsules|Formula30A Full Spectrum Hemp-Derived Cannabidiol (CBD) 25mg Capsules taken once daily for 8 weeks.
15730103|NCT05023746|Diagnostic Test|Genetron lung cancer panel|Follows the principle of synchronous blinding. The enrolled cases are coded, and the enrolled samples are detected with Genetron lung cancer panel and comparison methods. The detection results are compared, and the samples that are inconsistent with the detection results of similar products on the market are reviewed by the the Sanger sequencing method, when the site detection results compared with Sanger sequencing method are inconsistent, Sanger's detection results are recognized. The results were determined independently according to the cutoff values or interpretation requirements provided by each method, and relevant statistics were used to evaluate clinical application performance of Genetron lung cancer panel.
15730104|NCT05023733|Device|CONDUIT™ Interbody Platform composed of the EIT (Emerging Implant Technologies) Cellular Titanium®|Patients undergoing 1-2 contiguous levels of interbody fixation from a transforaminal approach for spinal segments L2-S1
15730105|NCT05023720|Other|nonintervention|
15730107|NCT05023694|Other|Video recordings|"In the first phase it will proceed to completion of the registration system by collecting data revivals and video recordings.
~In a second phase, the video is displayed and analysis of the resuscitation performance will take place. We will identify and make a registration of incidents. At this point the observational descriptive analysis will take place.
~Third phase: to develop preventive measures necessary to limit the number of incidents or to contain or minimize adverse effects resulting thereof: restructure and adapt the protocol."
15730108|NCT05023694|Other|Video recordings after corrective measures in adverse events|"Fourth phase: Training department staff on improvements to optimize performance times protocol using simulation.
~Fifth stage: final implementation of corrective measures of adverse events during the performance resuscitation.
~Sixth stage: successive evaluations of impact of corrective measures. With this evaluation, it will be held another descriptive case series. With the secondary formulate hypothesis after analysis of the errors, the protocol is optimized and measured if errors are minimized: analytical observational prospective cohort study."
15730109|NCT05023681|Drug|Recombinant Staphylokinase|Intravenous injection of r-SAK is administered within 10 minutes after diagnosis of acute ST-segment elevation myocardial infarction
15730110|NCT05023681|Drug|normal saline|Intravenous injection of placebo(normal saline ) is administered within 10 minutes after diagnosis of acute ST-segment elevation myocardial infarction
15730111|NCT05023668|Other|No intervention|No intervention
15730112|NCT05023655|Drug|Tazemetostat|800mg po twice daily
15730113|NCT05023642|Other|resistance training|"Interventions will include a three-phase strengthening training protocol.
~Adaptation phase: three sessions, emphasis on learning the technique, body self-awareness, and movement coordination;
~Basic phase: 12 sessions, to increase muscle strength; and
~Specific phase: 21 sessions, to intensify the process of strength gain and muscular hypertrophy.
~Participants will perform the following exercises during the strength-training protocol intervention: pec deck/seated lever fly, adductor, pulldown, abductor strengthening, alternating dumbbell curl, leg press at a 45-angle, triceps pulley, lateral raise, knee flexion and extension, ankle joint flexion and extension in the leg press, and crunches. If the participant has difficulty performing a specific exercise, an equivalent activity will replace it. From the eighth week onwards, participants will perform additional exercises focused on strengthening the gastrocnemius and soleus."
15730115|NCT05023616|Other|Real-time home CPR training|The participants in the intervention group will have Little Anne QCPR mannequins (Laerdal, Stavanger, Norway) delivered to their homes. The participants will use an online platform specifically developed for CPR training (HEROS Remote app). The training program will provide video-based self-instruction training followed by hands-on chest compression training with the instructor. The hands-on chest compression training session provides real-time chest compression quality measurement followed by real-time feedback from the instructor. Chest compression quality will be measured by Little Anne QCPR mannequins.
15730116|NCT05023616|Other|Conventional CPR training|"Participants in the conventional CPR training program group will be provided CPR education with the Home Education and Resuscitation Outcome Study (HEROS) program that is currently provided in Seoul, Korea. The HEROS program is a 1-hour training course, consisting of a 30-minute video-based self-instruction training with a mannequin. The program also includes a bystander CPR simulation with a simulated dispatcher using the participants own cell phone. Little Anne QCPR mannequins will be provided to measure and give feedback on the participants chest compression performance."
15730117|NCT05023603|Diagnostic Test|self-report questionnaire|Individual subject factors included and self-report questionnaires will be collected through an interview process.
15730118|NCT05023590|Procedure|ablation of left atrium during mitral valve open chest intervention|open chest mitral valve surgery (reconstruction or replacement) with additional ablation of left atrium by cryo or radio frequency method
15730119|NCT05023577|Drug|Rabeprazole|20mg bid
15730120|NCT05023577|Drug|Bismuth potassium citrate|0.6g bid
15730121|NCT05023577|Drug|Metronidazole|0.4g qid
15730128|NCT05023512|Behavioral|Communication about the COVID-19 vaccination from the Massachusetts Department of Public Health|Participants will be randomized to receive one of two different versions of messages from the Massachusetts Department of Public Health. The message that participants in each experimental group receive will vary slightly and systematically. Specific content and wording of these messages were developed to address and mitigate concerns about the Covid-19 vaccination.
15730129|NCT05023499|Drug|SYMPT-X Glutamine, Oral Powder for Reconstitution|erioperative glutamine supplementation (PGS) was defined as the subjects with five-day parenteral plus one-month oral use.
15730130|NCT05023486|Drug|NP-G2-044 Monotherapy|1600 mg QD and 2100 mg QD
15730131|NCT05023486|Drug|Anti-PD-(L)1 Therapy|previously initiated per standard of care, at a dose and frequency in accordance with the package insert
15730132|NCT05023486|Drug|NP-G2-044 Combination therapy|1200 mg QD or 1600 mg QD - starting dose
15730133|NCT05023473|Procedure|Pericapsular nerve group block|patients will receive pericapsular nerve group block
15730134|NCT05023473|Drug|Morphine Sulfate|morphine will be given to both groups as patient-controlled analgesia PCA
15730135|NCT05023460|Device|Paresthesia-free (burst) ONS|Stimulation intensity target of 60% of paresthesia threshold.
15730136|NCT05023460|Device|Placebo|ONS system deactivated
15730137|NCT05023447|Behavioral|BRIDGE Intervention|Intensive clinical assessment; >16 sessions of Cognitive Analytic Therapy (CAT); Development of a shared formulation
15730138|NCT05023447|Behavioral|Service as Usual|Likely to range from social services, mental-health services, forensic services to no intervention
15730139|NCT05023434|Procedure|Intraoperative Brain Simulation - Alternate Stimulation Parameters|Additional stimulation parameters outside of standard of care during intraoperative brain stimulation to aid in motor mapping.
15730140|NCT05023421|Other|no intervention|no intervention
15730141|NCT05023408|Drug|Bleomycin Injection|Intralesional Bleomycin used for treatment of cutaneous warts.
15730142|NCT05023408|Procedure|Cryotherapy|Cryotherapy used for comparison of efficacy.
15730144|NCT05023382|Drug|Teduglutide|Teduglutide 0.05 mg/kg SC injection
15730146|NCT05023356|Device|Non-contact vital signs monitoring with camera|Monitor patients face image by non-contact vital signs monitoring with camera
15730147|NCT05023343|Drug|Ropivacaine|30 mL Ropivacaine 0,75% administered as a unilateral TQL block
15730148|NCT05023343|Other|Quadriceps muscle strength|Quadriceps muscle strength is assessed using a hand-held dynamometer. Each participant is tested pre block administration and 60 minutes after
15730149|NCT05023343|Other|Timed Up and Go|To test mobilisation the standardised Timed Up and Go test is used. Each participant is tested pre block administration and 60 minutes after
15730150|NCT05023343|Other|Single-leg 6 meter timed hop test|To test muscle strength and power the single-leg 6 meter jump test is used. Each participant is tested pre block administration and 60 minutes after
15730151|NCT05023343|Other|Temperature discrimination|Dermatomal evaluation of cold and warm discrimination of the thoracic and lumbar dermatomes Approximately 60 minutes after block administration
15730152|NCT05023343|Other|Pinprick test|"Dermatomal evaluation of pinprick/sharp sensation of the thoracic and lumbar dermatomes.
~Approximately 60 minutes after block administration"
15730153|NCT05023343|Diagnostic Test|Blood samples|As a substudy the maximum serum concentration of ropivacaine is analyzed. Blood samples are taken at 0, 15, 30, 45 and 60 minutes after block administration
15730154|NCT05023343|Diagnostic Test|Non-invasive blood pressure measurement|Non-invasive blood pressure is measured prior to block administration and 30 minutes after block administration
15730155|NCT05023317|Behavioral|Strengths-based linkage to alcohol care|SLAC is a behavioral intervention designed to link persons with substance use/misuse to care
15730156|NCT05023317|Behavioral|Usual care|Usual care consists of brief screening and intervention and/or standard referral to alcohol care
15730157|NCT05023304|Drug|Dextenza 0.4Mg Ophthalmic Insert|The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration.
15730158|NCT05023304|Drug|Topical Prednisolone|Standard of care topical drop treatment
15730159|NCT05023291|Diagnostic Test|Positron Emissie Tomografie - Computer Tomografie|In this study, the high-resolution PET-CT system will be used to evaluate the cutting edges after tumor resection. The goal is to evaluate the distance of the tumor cells from the cutting edges of the surgical piece. The patient receives an intravenous injection of radiolabeled sugar (18F-FDG). 18F-FDG is the standard PET tracer for diagnostic PET-CT research. This standard dose will always be calculated according to the formula: 3.7 x body weight + 37 Mbq.
15730160|NCT05023278|Drug|Venlafaxine 37.5 MG|venlafaxine 37.5mg daily for 7 consecutive days.
15730161|NCT05023278|Drug|Placebo|placebo filled pill daily for 7 consecutive days.
15730162|NCT05023265|Radiation|Stereotactic body radiotherapy|SBRT is a non-invasive treatment approach that delivers precise and highly conformal radiotherapy to the tumour with steep dose gradients that minimize exposure to the surrounding normal tissues.
15730163|NCT05023252|Other|mobile application|VetThrive is a mobile smartphone application that monitors and transmits mobile sensor and utilization data. This app is deployed in Veteran patients who passively self-track their behaviors and psychiatric symptoms.
15730228|NCT05022745|Other|Multimodal, multidisciplinary approach|The patient management is adapted pre-operatively, per-operatively and post-operatively
15730164|NCT05023239|Other|UG-SZM Group|The patients will be receive Ultrasound-Guided Suprazygomatic Maxillary Nerve Blocks 10 mL of a local anesthetic mixture composed of 0.25% plain bupivacaine .
15730165|NCT05023226|Procedure|RM|RM refers to that under FiO2=100% oxygen concentration and fixed inspiratory pressure (15cmH2O), the PEEP starts from 10 cmH2O and increases at a pressure of 5 cmH2O every minute until the Peak inspiratory Pressure(PIP) reaches 55cmH2O, and the level was fixed to 40 seconds in each increment. Then, the ventilator was transferred to PEEP-titration phase, the PEEP was adjusted to 25 cm H2O, and it was reduced by increments of 5 cm H2O each time. The each increment was fixed to 5 minutes till the end-maneuver PEEP.
15730166|NCT05023226|Procedure|LPVS|LPVS was used by the pressure-controlled mode and the PEEP was titrated by the level of FiO2 to keep the saturation of oxygen (SaO2) more than 90%. The level of pressure control was adjusted to maintain low tidal volume (6-8 mL/kg predicted body weight [PBW]) strategy. The respiratory rate and tidal volume were setting to avoid unstable hemodynamic data and adjusted by blood gas data and lung mechanics.
15730167|NCT05023213|Behavioral|Warna-Warni Waktu|Six videos and eighteen reinforcer activities
15730168|NCT05023187|Behavioral|SCOT|"A 8-week social and cognitive online training to improve both cognitive and social functioning, which includes 2 sessions (~45 minutes each) of individual cognitive training through the BrainHQ© program 2020 (BrainHQ© Posit Science) and a psycho-educational group session for each week (24 sessions in total).
~In the experimental intervention, all activities are focused on enhancing executive functions (working memory, processing speed, inhibitory control etc.) and social cognition abilities (identifying/recognizing facial expressions, styles attribution, drawing conclusions etc.)."
15730169|NCT05023187|Behavioral|CON|"A 8-week active control intervention consisting of 2 sessions (~45 minutes each) of cognitive stimulation exercises and a group session for each week (24 sessions in total) during which the various cognitive domains are deepened and the exercises carried out during the week are reviewed all together.
~The online control intervention has been specifically designed to increase the cognitive involvement of the subjects and to replicate the condition of exposure to social dynamics."
15730172|NCT05023161|Biological|Blood samples|Performed a 10 ml blood sample in each of the 200 patients included.
15730173|NCT05023148|Procedure|Electroacupuncture|Stimulating acupoints using electric stimulator
15730174|NCT05023148|Procedure|Thread embedded acupuncture|Stimulating acupoints using thread embedded
15730175|NCT05023135|Device|DeepView SnapShot Portable (DV-SSP)|DV-SSP assistive imaging to collect observational data
15730176|NCT05023122|Dietary Supplement|vitamin D3|vitamin D3 (cholecalciferol) 800 IU QD
15730177|NCT05023122|Dietary Supplement|calcium|calcium citrate 600 mg QD
15730178|NCT05023109|Drug|GP+PD-1+Tight|"Drug: Tislelizumab Tislelizumab 200mg IV Q3W
~Other Name:
~BGB-A317 Anti-PD-1 therapy
~Drug: Ociperlimab Ociperlimab 900mg IV Q3W
~Other Name:
~BGB-A1217 Anti-TIGIT therapy
~Drug: GP chemotherapy gemcitabine 1000mg/m2 + cisplatin 25mg/m2 Q3W"
15730179|NCT05023096|Other|Tobacco product administration and assessment|Participants are first instructed to smoke their usual brand of menthol cigarettes normally for the next 7 days and avoid using any other tobacco products. After this baseline week, participants are randomized to 1 of 3 ENDS flavor conditions, all contain 5% nicotine (Mentol+Tobacco, Tobacco, Unflavored) with equal probability and provided with a supply of their condition specific ENDS and asked to use it in place of their usual menthol cigarettes for the next 6 weeks.
15730180|NCT05023083|Other|Functional Status Questionnaire Urdu version|The FSQ instrument translated into Urdu consists of only 34 items, main sections addressed physical function in the activities of daily living, psychological function, role function, social function and variety of performance measures.(8) Scores range from a 0 - 4, 1 - 4, and 1 - 6 scale per question depending on section. It increases reliability and patients ease and comfort. Total score range from 0 to 100 higher score represents the more severe condition.
15730181|NCT05023083|Other|Original Functional Status Questionnaire|FSQ was developed to allow the comprehensive and efficient assessment of physical, psychosocial, social, and role functioning in ambulatory patients. It is a self-administered survey that takes approximately 15 min to complete. The results can be scored to produce a one-page report for clinicians to use in their practices. The responses to items within a scale are averaged and transformed to a scale with a potential range of 0 to 100.Higher score represents the more severe condition.
15730182|NCT05023070|Drug|Cannabidiol|Nanoemulsion Cannabidiol 200 mg
15730183|NCT05023070|Drug|Cannabidiol|Nanoemulsion Cannabidiol 400 mg
15730184|NCT05023070|Drug|Cannabidiol|Epidiolex 400 mg
15730185|NCT05023070|Drug|Cannabidiol|Nanoemulsion Cannabidiol 400 mg
15730186|NCT05023057|Behavioral|Multidomain intervention|For 24 weeks, participants will receive cognitive training using the tablet PC application twice a week, exercise 3 times a week, nutrition education 12 times, anthropometric measurements and alcohol and smoking monitoring every 4 weeks, motivation reinforcement training 4 times.
15730187|NCT05023031|Drug|NVP-2102|Tablet formulation for oral administration, single dose of NVP-2102 at Day 1
15730188|NCT05023031|Drug|NVP-2102-R|Tablet formulation for oral administration, single dose of NVP-2102-R at Day 1
15730189|NCT05023018|Drug|NEO100|NEO100 is a purified form of perillyl alcohol.
15730190|NCT05023005|Other|Strain-Counterstrain treatment of piriformis muscle|Participant will lay prone on table with affected leg close to edge of table. Piriformis muscle tender point is identified and palpated. Then patient leg is passively moved off table and passive hip flexion, abduction, and possible internal/external rotation is added to reduce tender point by 70% or more. This is done passively. This position is held for 90 seconds and then participant is passively returned back to neutral prone position with leg on table. Tender point is palpated again to reassess for change in pain (using subjective visual analog scale). An algometer is also used pre and post to assess objective change in pressure pain threshold.
15730191|NCT05022992|Other|Resistance Training|Both groups will perform a resistance training session consisted of 10 reps x 3 set of upper- and lower-body resistance exercises.
15730313|NCT05021991|Drug|20 mg PRAX-944|Once daily oral treatment
15730314|NCT05021991|Drug|Placebo|Once daily oral treatment
15730192|NCT05022979|Other|Observational only|"The investigator collected the patient's data from the medical record and interviewed the patient to complete the nutritional questionnaire.
~The required biological, blood and urine samples were collected during routine blood sampling upon entry and hospitalization."
15730193|NCT05022966|Other|No intervention|Individuals did not received any intervention.
15730194|NCT05022953|Other|Education, dijital storytelling|Digital story
15730195|NCT05022940|Other|Usual gold-standard multidisciplinary rehabilitation for TBI|In individual and group interventions within a holistic interdisciplinary rehabilitation program focusing on resumption of daily activities and social roles. Interventions could include physiotherapy or physical training, occupational therapy, speech therapy, and neuropsychology/psychology, which aimed at reducing the impacts of cognitive difficulties in daily life by using self-guided and environmental strategies.
15730196|NCT05022927|Drug|ERY974|ERY974 vial
15730197|NCT05022927|Drug|Tocilicumab|Tocilizumab vial
15730198|NCT05022927|Drug|Atezolizumab|Atezolizumab vial
15730199|NCT05022927|Drug|Bevacizumab|Bevacizumab vial
15730200|NCT05022901|Combination Product|Melphalan (3 mg/kg IBW) with Hepatic Delivery System (HDS)|Melphalan administered directly to the liver via the Hepatic Delivery System (HDS) infused over a 30 minute period, followed by a 30 minute washout period
15730201|NCT05022888|Device|regional tissue saturation|tissue oxygen saturation measured from 4 different regions defined on the trapezius muscle. The NIRS probe will be used in these areas.
15730202|NCT05022875|Device|Healthcare CEO app- for experimental app intervention|The app content was designed based on the results of previous qualitative and Delphi studies (Chiang et al., 2021; Chiang et al., 2020) and consists of 11 interfaces: CEO's profile, Health Tracking, CEO Knowledge Base, Barrier-free Communication, See Here: Diet and Exercise, Help Me, Detective!, CEO Chatroom, CEO's Secretary, Who's the Best CEO, SOS Calls, and Q&A
15730203|NCT05022875|Device|Healthcare CEO app-for control app intervention|consists of 2 interfaces: CEO's profile, Health Tracking.
15730204|NCT05022862|Behavioral|Usual Care|Medication is dispensed to participant at each visit in 30-60 day supplies by Baltimore City Health Department (BCHD) nurses. For study participants, medication dispensation will occur in medication bottles with MEMS Caps, supplied by the study.
15730205|NCT05022862|Behavioral|Video Directly Observed Therapy alone|Usual care plus Video-DOT using the emocha platform, a HIPAA compliant commercial platform for video based DOT. The app allows a secure/encrypted video recording to be taken as the participant ingests the medication. Electronic text reminders will be sent to the participant on the smart phone when it is time to take the medication. The participant will record a video of the pill ingestion process. Study staff will verify each video to confirm the video shows the correct person and that the pill was ingested appropriately (according to standardized approach involving visualization of the pills, ingestion and observation of an empty mouth after ingestion).
15730206|NCT05022862|Behavioral|Video Directly Observed Therapy plus Financial Incentives|Usual care plus video-DOT and financial incentives contingent on adherence verified by video DOT. The amount of the financial incentive that can be earned for future verified doses decreases after a missed dose (video). The amount of the financial incentives increases incrementally back to baseline amount after verification of medication ingestion according to the prescribed schedule for several consecutive doses.
15730207|NCT05022849|Drug|JNJ-75229414|JNJ-75229414 infusion will be administered intravenously.
15730208|NCT05022849|Drug|Bridging Therapy|Bridging therapy including Anti-AR agents (example, abiraterone, enzalutamide) will be administered orally and radiotherapy, or chemotherapy (example, docetaxel) will be administered intravenously.
15730209|NCT05022836|Diagnostic Test|four-limb blood pressure measurements|Four-limb blood pressures were measured by certificated nurses at admission.
15730210|NCT05022823|Device|Compression sleeve, worn during exercise|Participants wear their daytime compression sleeve during the DPRE program.
15730211|NCT05022823|Device|Adjustable Compression (AC) garment, worn during exercise|Participants wear an Adjustable Compression (AC) garment during the DPRE program. Participants will be fitted for an Adjustable Compression garment and instructed in its application by a physical therapist.
15730212|NCT05022823|Device|Compression sleeve, daytime wear|Compression sleeve worn for at least 12 hours per day, seven days a week.
15730213|NCT05022823|Behavioral|Decongestive Progressive Resistance Exercise program|"Supervised DPRE exercise program, twice a week for 12 weeks. Exercises will be individualized and offered in a group-based format.
~After the 12-week intervention, participants will continue the same program (independently) twice weekly for an additional 12 weeks at home or in a community-based fitness center or attend supervised group exercise sessions virtually."
15730214|NCT05022823|Behavioral|Home exercise program|Participants are provided with a home exercise program that follows the decongestive exercise sequence and instructed to perform the exercise sequence once daily for a 10-15 minute period.
15730217|NCT05022797|Drug|Glucarpidase 1000 UNT [Voraxaze]|2 vials of 1000 units per vial
15730218|NCT05022784|Drug|Nintedanib|Nintedanib
15730219|NCT05022771|Drug|PMG1015 Dose 1|Dose level 1 of PMG1015
15730220|NCT05022771|Drug|PMG1015 Dose 2|Dose level 2 of PMG1015
15730221|NCT05022771|Drug|PMG1015 Dose 3|Dose level 3 of PMG1015
15730222|NCT05022771|Drug|PMG1015 Dose 4|Dose level 4 of PMG1015
15730223|NCT05022771|Drug|PMG1015 Dose 5|Dose level 5 of PMG1015
15730224|NCT05022771|Drug|PMG1015 Dose 6|Dose level 6 of PMG1015
15730225|NCT05022771|Drug|Placebo|Placebo to match
15730226|NCT05022758|Drug|Rivaroxaban (Xarelto, BAY59-7939)|One of NOAC (Non-vitamin K antagonist oral anticoagulants)
15730227|NCT05022758|Drug|Warfarin|One of OAC (Oral anticoagulation therapy)
15730315|NCT05021978|Drug|Part A: 20 and 40 mg PRAX-944|Once daily oral treatment
15730229|NCT05022732|Dietary Supplement|Polyglucosamine L112|750 mg of chitosan for tablet formulated with ascorbic acid and tartaric acids in the relative proportions of 91-6-3% with the addition of formulating excipients
15730230|NCT05022732|Combination Product|Placebo|excipients and gum arabic
15730231|NCT05022719|Device|PillCam Colon2 procedure with MB-MMX|Subjects will undergo a bowel preparation (split dose, 4L PEG), including 200 mg Methylthioninium chloride, corresponding to eight 25 mg MB-MMX tablets. An experienced Gastroenterologist will read the CCE procedure and complete a subjective questionnaire, to evaluate mucosal enhancement during a CCE procedure, when using MB-MMX as a contrast-enhancement technique.
15730232|NCT05022706|Other|Community-based accompaniment and home visits|"Trained health promoters will accompany adolescents to their first appointments; facilitate enrollment in public health insurance and completion of other administrative requisites (e.g. obtaining a foreign identification card for migrants; transferring to a different health facility); help troubleshoot new logistical and/or social challenges; and will foster communication between the adult care providers and the patient.
~Health promoters will visit the participant's home or another mutually-agreed upon location at least monthly, to review ART adherence, identify barriers to care and adherence, remind patients of upcoming medical encounters, screen and follow-up for clinical and social problems, and offer social support."
15730233|NCT05022706|Behavioral|Directly Observed Therapy|Among adolescents who have already initiated combination antiretroviral therapy (cART), directly observed therapy (DOT) will be provided to the subset of adolescents identified as being at high risk of non-adherence, defined by meeting at least one of the following criteria: 1) identified by the pediatric health provider as having unstable adherence; or 2) having a detectable viral load at one of their two previous measurements. In adolescents newly initiating cART, there will not be an adherence precedent. This group will choose whether they wish to receive DOT. As part of this research, trained community health workers (CHWs) will deliver DOT in participant's homes or in a mutually agreed upon location. CHWs will observe ingestion of cART daily, ensure it is taken as prescribed and record each dose as DOT, self-administered, not taken or not prescribed.
15730234|NCT05022706|Behavioral|Monthly Peer Support Groups|The investigators will assign ALWH to a social support group with 9 to 11 other adolescents also participating in the research. The goal of the social support groups is to provide a venue for participants to share experiences and resources and provide encouragement and support to one another. Each group will last approximately 3 to 4 hours. Support groups will be led by adult peers or trained community health workers. The final group session will incorporate a discussion about the group experience, how it may change behavior, recommendations for improvement, and unmet needs that should be considered for a future intervention.
15730235|NCT05022693|Drug|BIO89-100|Subcutaneous Injections
15730236|NCT05022680|Behavioral|mhealth|the peer-led intervention with mHealth technology (an application (APP) and Sports bracelet)
15730237|NCT05022667|Device|PTeye|The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscle, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console, as per device functionality requirements.
15730238|NCT05022654|Drug|SI-B001|Administration by intravenous infusion
15730239|NCT05022641|Device|PTeye|The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscle, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console (see Figure 1), as per device functionality requirements.
15730240|NCT05022628|Drug|Donafenib|"Donafenib treatment regimen.
~Donafenib started on the day of the first radiation treatment.
~starting dose 0.2 g bid twice daily orally on an empty stomach (1 hour before or 2 hours after a meal).
~Surgery after at least 1 week off Donafinil; resume Donafinil dosing as soon as possible after postoperative wound healing until any of the following occurs, whichever occurs first: (i) the subject develops an intolerable toxic reaction that does not resolve after dose adjustment (see 5.3 for details); (ii) 12 months of postoperative dosing; (iii) the subject has the first imaging-confirmed recurrence of disease or withdraws from the study (whichever occurs first).
~Dose adjustment/withdrawal: Subjects are allowed up to 2 dose adjustments if they experience an adverse event related to the trial drug during treatment."
15730244|NCT05022602|Device|Imagio|Imagio - both ultrasound probe and Duplex OA probe
15730245|NCT05022589|Other|Computerized Plasticity-Based Adaptive Cognitive Training|Computerized plasticity-based adaptive cognitive training requiring a total maximum of 40 treatment sessions, 3-4 sessions per week, ~30 minutes per session.
15730246|NCT05022576|Diagnostic Test|Robotic arm assisted PSMA PET/CT guided prostate biopsy|The patients were positioned prone on PET/CT table. The regional PET/CT image of the lower pelvic region were acquired for the procedure. The images were transferred to the ROBIO™ EX workstation. The ARA workstation determined the needle trajectory, depth of the lesion and angulations. The planned trajectory was appraised for its relationship with the vital organs. Strict surgical aseptic approach was followed for the procedure under local anesthesia. An 18G x 20cm coaxial system was manually introduced through the bush and pushed with the help of robotic arm through the gluteal skin entry site to the predetermined depth in the prostate. The real-time placement of the needle was confirmed with low dose CT and the biopsy specimens were retrieved. After the procedure, patient vitals and any difficulty in micturition were observed for two hours in the recovery area. The specimens were sent for histopathological examination.
15730247|NCT05022563|Drug|Parenteral anticoagulant|Parenteral anticoagulant only
15730248|NCT05022563|Drug|Warfarin|Warfarin-based
15730249|NCT05022563|Drug|Apixaban|Apixaban
15730250|NCT05022563|Drug|Rivaroxaban|Rivaroxaban
15730251|NCT05022563|Drug|Dabigatran|Dabigatran
15730252|NCT05022563|Drug|Edoxaban|Edoxaban
15730253|NCT05022550|Device|DEEP VR|DEEP VR is a virtual reality experience (i.e., video game using a head-mounted display) wherein participants ('players') traverse through a serene underwater adventure for approximately 15 min. Movement through the environment is facilitates through the cued use of regularized, diaphragmatic breathing, captured through a respiratory belt.
15730254|NCT05022537|Device|retrograde nephrostomy|this will consist of one visit to a urologist for retrograde nephrostomy placement using a Retroperc device with lithotomy performed in the same visit and follow up at 4 weeks and 6 months.
15730255|NCT05022537|Device|antegrade nephrostomy|this will consist of two visits, first to the interventional radiologist for antegrade nephrostomy placement followed by another visit to the urologist for lithotomy with follow up at 4 weeks and 6 months
15730256|NCT05022524|Dietary Supplement|Acetate (Apple Cider Vinegar)|Consumer-grade apple cider vinegar (ACV) capsules will have extra enteric coating applied for delivery further into the GI tract.
15730257|NCT05022511|Behavioral|Screening status|Women are offered check-up on screening status in both CCU and CRC screening. If a woman is not up to date in one or both screening programmes, she will be offered a self-sampling device and/or a FIT kit.
15730258|NCT05022498|Behavioral|Exercise|60 min treadmill exercise performed at 60% of maximum oxygen uptake.
15730259|NCT05022485|Device|ZNN Bactiguard tibia|Tibia fracture fixation
15730260|NCT05022472|Behavioral|COVID-19 Individual Awareness and Education.|The 2VIDA! working group has developed culturally competent COVID-19 educational and outreach materials (available printed and electronically) in English and Spanish that are written at the 8th grade level (the average reading level of adults in the United States) that peer-health educators will distributed to community members during their visits to the participating SYH community centers, door-to-door, local supermarkets, and CBO's in the selected communities. These materials have general information on COVID-19 as well as educational information and resources regarding COVID-19 prevention, symptoms, testing, contact tracing, COVID-19 vaccine (how it works, technology used, administration [2-dose series and importance of vaccine completion]), safety concerns, benefits, dispelling common misconceptions and misinformation, and other topics identified based on community needs. This information will be updated monthly to ensure the most up to date information.
15730261|NCT05022472|Behavioral|COVID-19 Community Outreach & Health Promotion.|Peer-health educators will work with local CBO's and facilitate a combination of live broadcast sessions, pre-recorded webinars, social media posts, and other outreach activities in English and Spanish reaching community members with information on the above COVID-19 related topics as well as other identified needs such as what to do if a family member is infected and where you can get the COVID-19 vaccine. The goal is to reach 10,000 viewers (per session) in the various social media platforms in the three randomly selected communities.
15730262|NCT05022472|Behavioral|COVID-19 Individual Health Education & Linkages to Medical and Supportive Services.|SYHealth will establish a COVID-19 Resource Center within the participating health centers in the three randomly selected communities (intervention sites only) providing individual COVID-19 related health education and linkages to medical and supportive services for patients and community members in need of additional education and support regarding COVID-19 disease and COVID-19 vaccine.
15730263|NCT05022472|Biological|Pop-up community vaccination sites|We will offer the COVID-19 vaccine at the participating SYHealth community health centers and pop-up vaccination stations that will be set-up in these communities (intervention sites) as part of the interventions efforts to increase access and uptake of the COVID-19 vaccine. We have identified various open spaces (e.g., public parks) in these communities to set-up the vaccination stations. Additionally, data will be collected to assess individual, social, and contextual factors related to access, acceptance, and uptake of the COVID-19 vaccine.The survey will last approximately 10-15 minutes and will be self-administered in both English and Spanish. Following the survey participants will be offered the COVID-19 vaccine and will be made an automatic appointment for the 2nd dose (4-week follow-up) and will be asked to complete a 5 min survey during the follow-up visit.
15730264|NCT05022459|Drug|Emicizumab|Patients in this group will be on standard of care Emicizumab prophylaxis for Hemophilia A
15730265|NCT05022459|Drug|FVIII|Patients in this group will be on standard of care FVIII prophylaxis for Hemophilia A
15730266|NCT05022446|Other|Survey Administration|Complete survey
15730267|NCT05022433|Procedure|UVC insertion|To compare two formulae namely UN-1 and Shukla method to estimate the UVC insertion length in achieving optimum UVC tip position.
15730268|NCT05022394|Biological|Nivolumab|Given IV
15730269|NCT05022394|Drug|Sapanisertib|Given PO
15730270|NCT05022381|Procedure|Radiofrequency thermal coagulation of articular branches of femoral and obturator nerves|Patients are operated under sedation in the operating room. C-arm fluoroscopy device is used for imaging purposes for radiofrequency thermocoagulation process. In order to prevent vascular injury, the needle is advanced under the guidance of ultrasonography. There are target points determined in fluoroscopy for the femoral nerve and the obturatory nerve. Before the thermocoagulation procedure, local anesthetic and steroid are injected into each of the target points. Patients who do not have any complications after the procedure and who are mobilized are discharged in the 2nd hour.
15730271|NCT05022368|Device|LabraGuard|Protection of the lips and the oral commissure during transoral procedures
15730273|NCT05022329|Biological|Pfizer-BioNTech COVID-19 Vaccine|This arm receives Pfizer-BioNTech COVID-19 Vaccine
15730274|NCT05022329|Biological|MODERNA SARS-CoV-2 Vaccine|This arm receives MODERNA SARS-CoV-2 Vaccine
15730275|NCT05022316|Other|CDS Tool Access|Clinics receiving the intervention will have access to EHR-based CDS tools designed to support social risk-informed care. Prior to tool activation in participating community health centers (CHCs), clinic staff members will be oriented to the CDS tools by an EHR trainer (either on-site or remotely).
15730276|NCT05022303|Drug|Larazotide Acetate|AT1001 10 μg/kg/dose up to 500 μg/dose (rounded to the nearest 50 μg) will be administered orally four times a day (QID) to the standard of care for MIS-C.
15730277|NCT05022303|Drug|Placebo|Matching placebo will be administered orally four times a day (QID) to the standard of care for MIS-C.
15730278|NCT05022290|Procedure|Single-syringe diluted with normal saline technique|Adenosine is mixed with normal saline up to 20 ml in a single syringe before administering to the patient by the IV bolus method.
15730279|NCT05022277|Behavioral|Low tech health SMS messages|Weekly health-related SMS messages are provided to adolescents.
15730280|NCT05022277|Behavioral|Low tech health Phone + SMS messages|Weekly health-related phone calls plus SMS messages are provided to adolescents.
15730281|NCT05022264|Diagnostic Test|RIA-VS|Measuring vital signs with a new contactless camera technique
15730282|NCT05022251|Procedure|Lumbar discectomy|surgically removing a hernia
15733977|NCT04993209|Biological|NDV-HXP-S B.1351 vaccine (Group B1e)|Stage B
15730283|NCT05022225|Other|None. This is a qualitative interview study.|There is no intervention in this study. This is a qualitative research study where participants will take part in focus group discussions.
15730284|NCT05022212|Drug|LACTIN-V|administered vaginally
15730285|NCT05022212|Drug|Placebo|administered vaginally
15730286|NCT05022199|Device|SPY fluorescent angiography|This group has had SPY fluorescent angiography used intraoperatively during urinary diversion. To be compared with historic controls who did not.
15730287|NCT05022186|Drug|Cannabidiol Oil|Patients will use it with specific instructions and they will be monitored at least one time in a month
15730288|NCT05022186|Drug|Homotaurine|Patients will use it with specific instructions and they will be monitored at least one time in a month
15730289|NCT05022173|Device|Helmet Non-Invasive Ventilation|The helmet interface is a modality which is used to deliver NIV to patients with respiratory failure. A transparent hood is placed over the entire head of the patient with a seal at the neck using a soft collar.
15730290|NCT05022173|Device|Facemask Non-Invasive Ventilation|The facemask interface is a modality which is also used to deliver NIV to patients with respiratory failure. A large mask covering the mouth and nose is strapped to the patient's face to create a seal.
15730291|NCT05022160|Drug|pudendal nerve block|All patients in the study group will receive bilateral pudendal nerve block at the end of surgery, with help of landmark technique, using 0.5% bupivacaine
15730292|NCT05022147|Device|High-Frequency-Only Stimulation|Control condition, constant high-frequency DBS stimulation (130Hz)
15730293|NCT05022147|Device|Low-Frequency-Only Stimulation|Experimental condition, constant low-frequency DBS stimulation (60 Hz)
15730294|NCT05022147|Device|Alternating, 50 sec High-Frequency, 10 sec Low-Frequency Stimulation|Experimental condition where stimulation frequency is changed from high (130Hz) to low (60Hz) frequency. The time interval for each frequency is 50 seconds for high, and 10 seconds for low, respectively.
15730295|NCT05022147|Device|Alternating, 50 sec High-Frequency, 50 sec Low-Frequency Stimulation|Experimental condition where stimulation frequency is changed from high (130Hz) to low (60Hz) frequency. The time interval for each frequency is 50 seconds for high, and 50 seconds for low, respectively.
15730296|NCT05022147|Device|Alternating, 10 sec High-Frequency, 50 sec Low-Frequency Stimulation|Experimental condition where stimulation frequency is changed from high (130Hz) to low (60Hz) frequency. The time interval for each frequency is 10 seconds for high, and 50 seconds for low, respectively.
15730297|NCT05022147|Device|Alternating, 10 sec High-Frequency, 10 sec Low-Frequency Stimulation|Experimental condition where stimulation frequency is changed from high (130Hz) to low (60Hz) frequency. The time interval for each frequency is 10 seconds for high, and 10 seconds for low, respectively.
15730298|NCT05022147|Drug|OFF Dopaminergic Medication|All six device interventions will be performed in medication OFF state
15730299|NCT05022147|Drug|ON Dopaminergic Medication|All six device interventions will be performed in medication ON state
15730300|NCT05022134|Behavioral|CHOICE-AYA|Adapted contraceptive counseling specific to AYA experiencing homelessness
15730303|NCT05022108|Biological|Alpha bisabolol gel|Using alpha bisabolol gel with a concentration of 0.5%, 2,5% or 5% to treat sensitized area with histamine.
15730304|NCT05022095|Other|Questionnaires|Diverse questionnaires have to be filled in.
15730305|NCT05022082|Other|Chest Physiotherapy- Aspiration- Inhaler drugs group|In the intensive care unit where the study was conducted, the patients who have a respiratory disorder and receive supplemental oxygen therapy with non-invasive mechanical ventilation or an oxygen mask are first administered an inhaler drug therapy placed in the physician's order. It is followed by chest physiotherapy and then oropharyngeal and nasopharyngeal aspiration. However, in practice rendered by the researcher, it is suggested that when chest physiotherapy and aspiration are administered in the first place and then followed by an inhaler drug therapy, it might have a more positive impact on the patient's physiologic parameters.
15730306|NCT05022043|Diagnostic Test|Serum Presepsin|Estimation of Serum Presepsin at time of admission
15730307|NCT05022030|Drug|mCapOX plus cetuximab|capecitabine 1000mg/m2 po bid d1-7+oxaliplatin ivgtt 85mg/m2 d1+cetuximab ivgtt 500mg/m2, q2w
15730308|NCT05022030|Drug|mFOLFOX6 plus cetuximab|oxaliplatin ivgtt 85mg/m2 d1+ leucovorin ivgtt 400mg/m2 d1+ fluorouracil iv bolus 400mg/m2 d1+ fluorouracil 2400mg/m2 continuous infusion for 46h+cetuximab ivgtt 500mg/m2, q2w
15730309|NCT05022004|Drug|Brinzolamide ophthalmic suspension|dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
15730310|NCT05022004|Drug|Azopt®|dose: one drop of study medication; frequency: three times a day; route of administration: Topical ocular administration; duration of therapy: 6 weeks
15730311|NCT05021991|Drug|120 mg PRAX-944|Once daily oral treatment with titration
15730312|NCT05021991|Drug|60 mg PRAX-944|Once daily oral treatment with titration
15730316|NCT05021978|Drug|Part B: 120 mg PRAX-944|Once daily oral treatment with titration
15730317|NCT05021978|Drug|Part B: 120 mg PRAX-944 and Placebo|Once daily oral treatment with titration followed by placebo
15730318|NCT05021965|Procedure|different combined of tooth bleaching procedure|The participants will be randomly allocated into 4 groups and receive different kind of tooth bleaching protocol.
15730319|NCT05021952|Device|mHealth App and wearable device|An intervention group (App+IoT device) uses a smart care application for 12 months. This application was tailored for prostate cancer patients and created by reflecting the treatment process after surgery. And they also uses a wearable smart band for 12 months.
15730320|NCT05021939|Other|2-Dimensional Group|In the 2-Dimensional Group, 2D VR gaming training in addition to traditional vestibular rehabilitation will be employed. In this group, the 'Verti-Go' game from the Playstation 4 VR gaming device will be played in 2D for 20-25 minutes, as well as vestibular therapy for 20-25 minutes. A total of 45-50 minutes will be given over the course of 8 weeks, 3 sessions per week. The intensity of treatment will rise with each session, depending on how well the patient cooperates. Evaluation will be done at the beginning and in the 8th week.
15730321|NCT05021939|Other|3-Dimensional Group|In the 3-Dimensional Group, 3D VR gaming training in addition to traditional vestibular rehabilitation will be employed. In this group, the 'Verti-Go' game from the Playstation 4 VR gaming device with 3D glasses will be played for 20-25 minutes, as well as vestibular therapy for 20-25 minutes. A total of 45-50 minutes will be given over the course of 8 weeks, 3 sessions per week. The intensity of treatment will rise with each session, depending on how well the patient cooperates. Evaluation will be done at the beginning and in the 8th week.
15730322|NCT05021926|Device|DKL crosslinked sodium hyaluronate 26|is injected into the midface on Day 1. The volume of injection will not exceed 2 mL per side. If applicable, a touch-up of DKL crosslinked sodium hyaluronate 26 will be injected on Day 30; the volume of injection will not exceed 1 mL per side.
15730323|NCT05021926|Device|Juvéderm Voluma™ with lidocaine (Allergan, Inc)|is injected into the midface on Day 1. The volume of injection will not exceed 2 mL per side. If applicable, a touch-up of Juvéderm Voluma™ will be injected on Day 30; the volume of injection will not exceed 1 mL per side.
15730324|NCT05021913|Device|DKL crosslinked sodium hyaluronate 23|is injected into the NLF on Day 1. The volume of injection will not exceed 2 mL per side. If applicable, a touch-up of DKL crosslinked sodium hyaluronate 23 will be injected on Day 30; the volume of injection will not exceed 1 mL per side.
15730325|NCT05021913|Device|Juvéderm Volift™ with lidocaine (Allergan, Inc)|is injected into the NLF on Day 1. The volume of injection will not exceed 2 mL per side. If applicable, a touch-up of Juvéderm Volift™ will be injected on Day 30; the volume of injection will not exceed 1 mL per side.
15730326|NCT05021900|Drug|Tenalisib|Tenalisib will be administered 800mg BID, orally
15730327|NCT05021900|Drug|Tenalisib|Tenalisib will be administered 1200mg BID, orally
15730328|NCT05021887|Drug|Fluticasone Propionate 100 mcg/Blister Oral Inhalation Powder/Respirent Pharmaceuticals|2 inhalations of Test and Reference product in each study period
15730329|NCT05021887|Drug|FLOVENT DISKUS|2 inhalations of Test and Reference product in each study period
15730330|NCT05021874|Other|Four different physiotherapy treatment|Four different physiotherapy treatment will be used for, to reduce pain and tension in the masseter muscles. The assessment of pain intensity on the VAS scale will be assessed each time after the therapy. After the 10th day of therapy, it will be measured ROM.
15730331|NCT05021861|Drug|Cyproterone Acetate, Ethinyl Estradiol Drug Combination|FEMALE PATIENTS WITH PCOS ON CPA/EE DRUG REGIMEN FOR ATLEAST 6 MONTHS
15730332|NCT05021861|Diagnostic Test|FEMALE PATIENTS WITH PCOS|FEMALE PATIENTS WITH PCOS( NEWLY DIAGNOSED) ,NOT ON ANY MEDICATION,
15730333|NCT05021861|Diagnostic Test|Control group|SYSTEMICALLY HEALTHY FEMALES
15730334|NCT05021848|Other|partnered multicomponent exercises program|aerobic,strength, flexibility and balance exercises and game
15730337|NCT05021822|Procedure|Erector spinae plane block|Bilateral erector spinae plane block will be performed preoperatively under ultrasound guidance using 15 ml bupivacaine on each side
15730338|NCT05021809|Drug|Calcium hydroxide intracanal medication application|The patient will be anaesthized with Articaine hydrochloride 40 mg/ml + 1/100000 Epinephrine bitartrate solution . Then the rubber dam isolation will be conducted, the access will be opened and then cleaning and shaping will be done by using Protaper Next rotary file system and irrigation by sodium hypochlorite 2.5% by side vented needle, EDTA 17%, sodium hypochlorite and the final rinse by saline where the canal will be dried by absorbent paper point. The application of calcium hydroxide intracanal medication will be done according to the manufacturer instructions then temporization by glass ionomer will be applied .
15730339|NCT05021783|Diagnostic Test|Pressure pain threshold|The sacroiliac PPT scores will be obtained bilaterally from four measurement points; the first point is located 1 cm medially and caudally from spina iliaca posterior superior (SIPS) and 3 more laterally, medially and cranially.The left trapezius muscle will be used to evaluate distant control point .The 1 cm2 algometer probe will be placed vertically in the each selected point and pressure will be increased with 0.1 kg/sc until the participant reporting pressure became painful. The pressure value at which the pain is first felt will be accepted as the PPT of that point.
15730340|NCT05021783|Diagnostic Test|Central Sensitization Inventory|Standardized questionnaire to determine the level of central sensitization
15730341|NCT05021783|Other|Spondyloarthritis Research Consortium of Canada scoring system|SPARCC scoring consists of two subcomponents to detect sacroiliitis activation and structural damage. In the short tau inversion recovery (STIR) sequence, 6 consecutive coronal sections will be examined and the signal increase will be scored as 0 = normal signal and 1 = increased signal. In this way, the maximum score can be 12 in a single coronal section. Evaluations Total maximum score of 72 in 6 consecutive coronal sections. In structural scoring, similar to sacroiliitis scoring, the SI joint is divided into four quadrants to evaluate whether there is fatty change, erosion, backfill and ankylosis. Each lesion is scored as 0=absent or 1=present. In this way, fatty change and erosion can be scored between 0-40 and backfill and ankylosis can be scored between 0-20 in 5 consecutive sections in total scoring.
15730430|NCT05021107|Other|FDM without isometrics|FDM without isometrics will be done
15730342|NCT05021783|Diagnostic Test|Temporal Summation|TS will be evaluated over the trapezius muscle and sacroiliac joints with manuel algometer. In the evaluation of TS, a pressure as much the PPT value of each point will be applied with pain pressure algometer ten times with a 1-second interstimulus interval. Patients will be asked to rate their pain using on a 0 to 10 visual analogue scale (VAS) at 0, 5, and 10 seconds. TS will be calculated by subtracting the rating at 0 seconds from the rating at 10 seconds. The point that is located 1 cm medially and caudally from SIPS was used for SI joint TS measurement on both sides.
15730343|NCT05021783|Diagnostic Test|Conditioned pain modulation|First stimulus will be applied to trapezius with the pressure that induced a pain intensity of 4 point on a 10 point VAS as called a test stimulus. After that the right hand of the patient will be immersed in 7 Celsius water for 20 seconds to create a conditioning stimulus. Second test stimulus with the same intensity of first one will be applied to trapezius after the conditioning stimulus and patients will be asked to rate their pain. If the patients cannot hold their hand in the water for 20 seconds, the test stimulus will be applied immediately after the patients removed their hands out of water. The ratio between the first and second VAS values multiplied by 100 will be defined as CPM score
15730344|NCT05021770|Drug|Orelabrutinib|150mg or 200mg orally daily
15730345|NCT05021770|Drug|Orelabrutinib|RP2D
15730346|NCT05021770|Drug|Thiotepa|30 mg/m2 intravenously every 3 weeks (maximum 6 cycle)
15730347|NCT05021757|Device|Shockwave C2 Coronary IVL|PCI procedure using a Shockwave C2 coronary IVL catheter
15730348|NCT05021731|Drug|Rifampicin plus Isoniazid|Administration of rifampicin plus isoniazid for latent tuberculosis
15730349|NCT05021731|Drug|Rifapentine plus Isoniazid|Administration of rifapentine plus isoniazid for latent tuberculosis
15730350|NCT05021731|Drug|Rifampicin alone|Administration of rifampicin alone for latent tuberculosis
15730351|NCT05021718|Other|Strengthening exercises|Back and hip strengthening exercises. The intensity of exercises was based on the exercise tolerance and pain thresholds of the individual subjects.
15730352|NCT05021718|Drug|Pharmacological therapy|Naproxen (500 mg) and Baclofen (10 mg) tablet twice a day for three weeks
15730353|NCT05021718|Other|Hot compression|Hot moist compression from week 4 to week 6.
15730354|NCT05021718|Behavioral|Activities to daily living instructions|"Avoid forward bending.
~Avoid heavy weightlifting.
~Avoid prolong standing.
~Avoid prolong sitting.
~Use a plain firm bed.
~Lie down in a supine position."
15730355|NCT05021692|Behavioral|Web-based support program for pregnant women with preeclampsia based on the Health Promotion Model|support program
15730356|NCT05021679|Other|AMP Implementation|Each study site will implement the Johns Hopkins AMP program at different times. The AMP program includes nursing staff training on the goals of AMP, how to complete mobility-focused outcome measures, set mobility goals, and to safely mobilize/ambulate patients. The AMP program also includes embedding these outcome measures and mobility goals into electronic medical records and producing weekly/monthly reports that show how often nursing staff score patient mobility and help patients meet daily activity goals.
15730357|NCT05021666|Drug|Placebo|matching placebo
15730358|NCT05021666|Drug|PB 718|dose in the next group will be determined following a review of data from the previous group
15730359|NCT05021653|Other|no intervention|No intervention involved
15730360|NCT05021640|Drug|DCR-AUD|DCR-A1203, the drug substance of DCR-AUD, is a synthetic double-stranded (hybridized duplex) RNA oligonucleotide conjugated to GalNAc ligands that enable specific hepatic access and uptake after subcutaneous administration. DCR-AUD is a sterile solution of DCR-A1203 at a concentration of 160 mg/mL in water for injection (WFI).
15730361|NCT05021640|Drug|Placebo for DCR-AUD|0.9% saline for injection
15730362|NCT05021627|Procedure|Cardiac autonomic nerve modification|Patients with sinus bradycardia undergoing cardiac autonomic ganglion ablation. Specific anatomic ablation of the 4 major left atrial GP and aorta-superior vena cava (Ao-SVC) GP was performed. Briefly, catheter ablation was performed under the guidance of an electroanatomic mapping system (CARTO,BiosenseWebster,DiamondBar,California). After completed the electroanatomic mapping of the left atrium was complete and pulmonary vein (PV) ostia identified, presumed GP clusters were ablated 1 to 2cm outside the PV-left atrium junctions at the following sites: the left superolateral area (leftsuperior GP[LSGP]), the leftinfer oposterior area(left inferior GP[LIGP]), the right superoanterior area (rightanterior GP[RAGP]), the right inferoposterior area(right inferior GP[RIGP]), and the Ao-SVC fat pad (Ao-SVCGP), and in that sequence.
15730363|NCT05021627|Procedure|Pacemaker implantation|Patients with sinus bradycardia received pacemaker implantation. The patient lay flat on the bed, puncture the subclavian vein and insert two guide wires. Cut the skin under the guide wire to make a skin bag, and stop bleeding accurately to avoid continuous bleeding of the skin bag. The pacemaker electrode is inserted into the heart cavity by guiding the guide wire, one is placed in the ventricle and the other in the atrium, and the corresponding parameters of the electrode, such as pacing threshold, impedance, etc., are measured at the same time. If the parameters are good, fix the electrode, connect the electrode with the pacemaker, place the pacemaker in the skin bag, fix the pacemaker and electrode, suture the skin layer by layer, and the operation is completed.
15730364|NCT05021614|Device|Valveclip® Transcatheter mitral valve repair|Transcatheter mitral valve repair system
15730365|NCT05021601|Procedure|Bi-atrial ablation|This intervention includes mitral valve surgery concomitant with left atrial ablation and right atrial ablation.
15730366|NCT05021601|Procedure|Left atrial ablation|This intervention includes mitral valve surgery concomitant with left atrial ablation alone.
15730367|NCT05021588|Procedure|steroid and anticoagulants according to different protocols.|As no standard treatment for COVID-19 was approved; there are many treatment protocols for anti-inflammatory corticosteroids and anti-coagulantsfor severe COVID-19 pneumonia cases, this study aims to assess the most suitable modality in this high-risk group.
15730368|NCT05021575|Other|Data collection on outpatient care|"Outpatient data from 1 January to 30 November of the analysed year were obtained from National Health Insurance Fund under the Ministry of Health.
~Outpatient data related to cardiovascular diseases (CVD) were collected as described:
~data on visits were collected using ICD-10 codes I00-I99 and other CVD related codes (e.g., certain Z, Q codes, J81.0, R57.0)
~data were collected from CVD prevention program
~data on interventional cardiology were collected from day care facility regardless of the diagnosis.
~Date of the visit, patient age, sex and municipality, service level (primary, secondary or tertiary), type of service and main diagnosis were recorded."
15730369|NCT05021575|Other|Data collection on hospitalisation|"Hospitalisation data from 1 January to 30 November of the analysed year were obtained from National Health Insurance Fund under the Ministry of Health.
~Data on hospitalisation were collected if any of the diagnoses (principal or secondary) were in I00-I99 range. Hospitalisation data covered hospitalisation date, patient age, sex, municipality and outcome. Data on cardiovascular procedures performed during hospitalisations included date of the procedure and ACHI (Australian Classification of Health Interventions) code."
15730370|NCT05021575|Other|Data collection on cardiovascular mortality|Data on cardiovascular mortality were obtained from death certificates provided by Causes of Death Registry from Institute of Hygiene and covered the period from 1 January to 31 December of the analysed year. Death certificates were included in the study when cause of death was adjudicated to be in I00-I99 range. Date and place of death (hospital, home, other or unspecified), patient age and sex were recorded.
15730371|NCT05021575|Other|Data collection of patients presenting to the tertiary care centre with acute coronary syndrome|Demographic, clinical and percutaneous coronary intervention (PCI) related data were collected from 1st March to 30th June of the analysed year. The timing of the chest pain onset, call for medical help, first medical contact (FMC), arrival to PCI centre, and PCI procedure were analysed.
15730372|NCT05021562|Drug|Niraparib|Niraparib capsules
15730373|NCT05021549|Device|nasal prong|apneic preoxygenation group (30 patients), will receive 10 L/ min of O2 via nasal prong during preintubation apnia
15730374|NCT05021536|Other|Placebo|Matching Placebo Comparator
15730375|NCT05021536|Drug|AMX0035|Proprietary formulation of taurursodiol and sodium phenylbutyrate
15730376|NCT05021523|Other|Hot ambient conditions exposures|Participants rest or exercise for 40min to 1h daily in hot ambient conditions
15730377|NCT05021523|Other|Immobilization|Participants are wearing a walking boot (with crutches) for 2 weeks
15730378|NCT05021510|Other|Simultaneous Cervical Traction & Neural Mobilization|Simultaneously Mechanical Cervical traction with Neural Mobilization of the upper limb for 3 times a week, 45 minutes per day for 4 weeks
15730379|NCT05021510|Other|consecutive Cervical Traction & Neural Mobilization|consecutive Mechanical Cervical traction with Neural Mobilization of the upper limb for 3 times a week, 45 minutes per day for 4 weeks
15730380|NCT05021497|Other|Global Positional Re-education|A series of gentle active movements and postures aimed at realigning joints and stretching shortened muscles. GPR includes 8 therapeutic postures in lying, sitting and standing.
15730381|NCT05021497|Other|Conventional Physical Therapy Program|Axial traction will be given for 5 minutes, followed by mobilization of the muscle fascia along with static stretching of the scalene, levator scapulae, upper trapezius, sternocleidomastoid and pectoralis minor muscles.
15730382|NCT05021484|Drug|Felzartamab|Intravenous infusion in regular intervals over 6 months
15730383|NCT05021484|Drug|Placebo|Intravenous infusion in regular intervals over 6 months
15730384|NCT05021471|Other|biofeedback|Twenty nine (29) patients will be treated stretching of hamstring with pressure biofeedback.
15730385|NCT05021471|Other|hamstrings stretching|Twenty nine (29) patients will be treated stretching of hamstring without pressure biofeedback.
15730386|NCT05021458|Other|Gong's mobilization|Ten patients will be treated with Gong's mobilization.
15730387|NCT05021458|Other|SNAG|: Ten patients will be treated with SNAGs
15730388|NCT05021445|Combination Product|plates based exercises|12 elderly participants receive intervention protocol of Plates- based exercises program total 12-sessions will be given for thrice a week for four weeks for 50-minutes.
15730389|NCT05021445|Combination Product|conventional exercises|12 elderly participants,intervention protocol of Conventional balance training exercises,total 12-sessions will be given for thrice a week for four weeks for 50-minutes.
15730390|NCT05021432|Other|Virtual reality training group|This group will receive video based games
15730391|NCT05021432|Other|Circuit Training group|They will receive Task-oriented Circuit training exercise program
15730392|NCT05021419|Other|Streamlined protocol|A streamlined drug protocol for optimizing heart failure medication
15730393|NCT05021419|Other|Standard Protocol|Current standard optimization protocol as per NICE and ESC
15730394|NCT05021406|Drug|Carvedilol 12.5 MG|Carvedilol is started at a dose of 6.25 mg once per day, and will increase to a dose of 12.5 mg once per day after 1 week. Target dose will be maintained at 12.5 mg once per day if patients with systolic blood pressure not lower than 90 mm Hg and HR no less than 50 beats/min.
15730395|NCT05021393|Other|Clinical Pharmacist Intervention|Medication review, patient education, counseling, and corresponding written recommendation will be performed by clinical pharmacists for all randomized patients.
15730396|NCT05021380|Other|GROUP|Non-invasive diagnosis of dental pain, dental root canal treatment, salivary specimen collection from the first visit to next and the last during 4 weeks of dental care
15730397|NCT05021367|Drug|TQB3823 tablets|TQB3823 is a small molecule Poly ADP-ribose Polymerase (PARP) inhibitor that can inhibit the enzyme activity of PARP1/2, making it difficult to repair the DNA in cancer cells, leading to cell death and delaying or blocking tumor development.
15730398|NCT05021354|Combination Product|Lateral epicondylalgia|dry needling, stretching and eccentric exercise
15730399|NCT05021341|Dietary Supplement|Berberine|For each visit, all participants will report to the laboratory between 0600 - 1000 hours after observing an 8 - 10 hr fast. Participants will ingest the double-blinded supplement (500 mg of berberine) at specific times, the day before and morning of study visits 2 - 5. For each visit, participants will have their heart rate, blood pressure, body mass, and height measured. After final ingestion of their assigned supplementation dose, standard multiple sample phlebotomy approaches will be used to collect 10 mL of venous blood from a forearm vein at 0, 20, 40, 60, 90, and 120 minutes post-supplement ingestion. After donating baseline blood sample (0-min) a standard test meal, white bread, and glucose powder mixed in 250 mL of water. The complete nutritional breakdown of the test meal is anticipated to be 382 kcal, 3.2 grams of fat, 80.6 grams of carbohydrate, and 7.64 grams of protein.
15730426|NCT05021133|Behavioral|Tele-Navi LCS|Tele-Navi of LCS includes: telehealth coaching from a Tele-Navigator for patients undergoing LCS to access a patient portal and a video-call system.
15730427|NCT05021120|Biological|AK127|Subjects will receive AK127 by intravenous administration
15730428|NCT05021120|Biological|AK104|After AK127 infusion, on the same day subjects will receive AK104 by intravenous administration
15730400|NCT05021341|Dietary Supplement|Dihydroberberine 200|For each visit, all participants will report to the laboratory between 0600 - 1000 hours after observing an 8 - 10 hr fast. Participants will ingest the double-blinded supplement (200 mg of dihydroberberine) at specific times, the day before and morning of study visits 2 - 5. For each visit, participants will have their heart rate, blood pressure, body mass, and height measured. After final ingestion of their assigned supplementation dose, standard multiple sample phlebotomy approaches will be used to collect 10 mL of venous blood from a forearm vein at 0, 20, 40, 60, 90, and 120 minutes post-supplement ingestion. After donating baseline blood sample (0-min) a standard test meal, white bread, and glucose powder mixed in 250 mL of water. The complete nutritional breakdown of the test meal is anticipated to be 382 kcal, 3.2 grams of fat, 80.6 grams of carbohydrate, and 7.64 grams of protein.
15730401|NCT05021341|Dietary Supplement|Dihydroberberine 100|For each visit, all participants will report to the laboratory between 0600 - 1000 hours after observing an 8 - 10 hr fast. Participants will ingest the double-blinded supplement (100 mg of dihydroberberine) at specific times, the day before and morning of study visits 2 - 5. For each visit, participants will have their heart rate, blood pressure, body mass, and height measured. After final ingestion of their assigned supplementation dose, standard multiple sample phlebotomy approaches will be used to collect 10 mL of venous blood from a forearm vein at 0, 20, 40, 60, 90, and 120 minutes post-supplement ingestion. After donating baseline blood sample (0-min) a standard test meal, white bread and glucose powder mixed in 250 mL of water. The complete nutritional breakdown of the test meal is anticipated to be 382 kcal, 3.2 grams of fat, 80.6 grams of carbohydrate, and 7.64 grams of protein.
15730402|NCT05021341|Dietary Supplement|Placebo|For each visit, all participants will report to the laboratory between 0600 - 1000 hours after observing an 8 - 10 hr fast. Participants will ingest the double-blinded supplement (Maltodextrin placebo) at specific times, the day before and morning of study visits 2 - 5. For each visit, participants will have their heart rate, blood pressure, body mass, and height measured. After final ingestion of their assigned supplementation dose, standard multiple sample phlebotomy approaches will be used to collect 10 mL of venous blood from a forearm vein at 0, 20, 40, 60, 90, and 120 minutes post-supplement ingestion. After donating baseline blood sample (0-min) a standard test meal, white bread, and glucose powder mixed in 250 mL of water. The complete nutritional breakdown of the test meal is anticipated to be 382 kcal, 3.2 grams of fat, 80.6 grams of carbohydrate, and 7.64 grams of protein.
15730403|NCT05021328|Drug|Toripalimab|Toripalimab 240mg, ivgtt, d1, q3w.
15730404|NCT05021328|Drug|Anlotinib|Anlotinib 12 mg/d, d1-14, q3w.
15730405|NCT05021328|Drug|SBRT 7Gy✖️5 QD|SBRT 7Gy✖️5 QD
15730406|NCT05021315|Drug|10% povidone iodine|50 women who received preoperative vaginal cleansing with 10% povidone iodine.
15730407|NCT05021302|Procedure|NOVAMAG NT-60|The Electromagnetic stimulation consists of 15 sessions with 20 minutes duration and three times a week. The total length of therapy is five weeks.
15730408|NCT05021302|Behavioral|Kegel Exercises|Self-supporting pelvic floor muscle strengthening exercises performed at home by contracting and relaxing quickly (2 seconds of contraction and 4 seconds of rest), followed by a slow contraction (contraction for 5 seconds, and rest for 10 seconds with five times each) five sets per day. The average length of exercise for each session is 2 minutes, with total exercise per day is 50 times. Thus, the total length of exercise is 10 minutes. It was done every day for eight weeks.
15730409|NCT05021289|Behavioral|guided imagery|guided imagery
15730410|NCT05021276|Drug|Ruxolitinib|Ruxolitinib and basiliximab are both second-line treatment for grade 3-4 steroid-resistant acute graft-versus-host disease.
15730411|NCT05021263|Drug|IV Medications|IV magnesium sulfate, used to replete magnesium stores
15730412|NCT05021263|Drug|GABA agonist|Pregabalin (oral), current standard of care for ERAS
15730413|NCT05021263|Other|placebo|placebo
15730414|NCT05021250|Procedure|Lipiodol marking|HCC patients treated with TACE and the tumor marked with lipiodol.
15730415|NCT05021237|Radiation|Ultra-fractionated radiation therapy|Patients enrolled in this study are planned to receive systemic therapy. Imaging based Ultra-fractionated radiation therapy using a PULSAR technique, which is 5 pulses to gross tumor in pelvis.
15730416|NCT05021224|Behavioral|Rapidly prototype and test strategies|We will generate strategies for facilitating treatment initiation that address barriers and leverage facilitators, in partnership with a team of experts in behavioral science and implementation science. We will favor simple, established strategies with freely available resources (e.g., Caring Contacts templates) to promote scalability, but will also consider other potential strategies as indicated. We will explore both low- (e.g., manualized text messaging) and high-tech (e.g., EHR integrated patient messaging) strategies to maximize relevance across contexts. Next, prototype-strategy designs will be validated through rapid-cycle tests in this real world context and in a manner that is inexpensive and allows us to fail fast and learn quickly. After testing a given implementation strategy, the team will debrief and decide whether to refine or adjust it.
15730418|NCT05021172|Other|Best Practice|Receive usual care
15730419|NCT05021172|Other|Informational Intervention|Receive Passport to Health booklet
15730420|NCT05021172|Other|Questionnaire Administration|Complete ePrognosis
15730421|NCT05021172|Other|Survey Administration|Ancillary studies
15730422|NCT05021159|Other|MTX, (but the investigator is not using any intervention, the participants are already taking it in their treatment protocol and the investigator is just analyzing p-gp expression)|the investigator is not using any intervention, the participants are already taking it in their treatment protocol and the investigator is just analyzing p-gp expression
15730423|NCT05021146|Other|usual care and topical essential copaiba oil|All subjects will receive daily interdisciplinary - multimodular -treatment during their hospital stay including a daily 30 minute massage therapy. Both experimental groups and the placebo group patients continue to use topical treatment in the first half of the follow up period (90 days).
15730424|NCT05021146|Other|usual care and placebo treatment|All subjects will receive daily interdisciplinary - multimodular -treatment during their hospital stay including a daily 30 minute massage therapy. Both experimental groups and the placebo group patients continue to use topical treatment in the first half of the follow up period (90 days).
15730425|NCT05021146|Other|usual care|All subjects will receive daily interdisciplinary - multimodular -treatment during their hospital stay.
15730429|NCT05021107|Other|FDM with isometrics|FDM with isometrics will be done
15730431|NCT05021094|Drug|Kuntai Capsule|The instructions is pointed that each Kuntai capsule is 0.5g and the usage of Kuntai capsule is oral taking 4 capsules each time, 3 times a day, and 4 weeks is a course of treatment. The patients will taking 3 course of treatment in this study.
15730432|NCT05021094|Drug|Femoston|The estrogen and progesterone sequential regimen was adopted. The Femoston was contain estradiol tablets and estradiol didroxyprogesterone tablets. Red tablets (estradiol, 1 mg/d) were taken in the first 14 days, and gray tablets (estradiol, 1 mg/d, dydrogesterone,10 mg/d) were taken in the last 14 days. 28 days was a course of treatment, and three courses of treatment were taken. The patients will taking 3 course of treatment in this study.
15730433|NCT05021081|Device|TRP-200|JJVC Investigational Contact Lens
15730434|NCT05021081|Device|ACUVUE Oasys 1-Day|JJVC Marketed Contact Lens
15730435|NCT05021068|Other|Postural Assessment|Spinal mouse measurement
15730436|NCT05021016|Biological|EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19)|"The EpiVacCorona vaccine is intended to prevent COVID-19. The vaccine relies on chemically synthesized peptide antigens of SARS-CoV-2 proteins conjugated to a carrier protein and adsorbed on an aluminum-containing adjuvant (aluminum hydroxide).
~The vaccine induces the specific immunity against the SARS-CoV-2 coronavirus following two intramuscular injections spaced 21 to 28 days apart.
~The EpiVacCorona vaccine contributes to the development of protective immunity against SARS-CoV-2 coronavirus following two intramuscular administrations given 21 to 28 days apart."
15730437|NCT05021003|Other|pressure biofeedback|: Core stabilization training with pressure biofeedback unit
15730438|NCT05021003|Other|core stabilization exercises|: Core stabilization training without pressure biofeedback unit
15730439|NCT05020990|Device|Lens A (Test)|Test toric lens
15730440|NCT05020990|Device|Lens B (control)|Control toric lens
15730441|NCT05020977|Other|Blood pressure, physical activity, health|Observational study of work environment, leisure time, blood pressure, physical activity and health
15730442|NCT05020964|Drug|Trastuzumab and Pyrotinib|"Trastuzumab: 3-week dosing regimen, The initial load dose was 8 mg/kg. Pyrotinib: 400 mg orally once daily, take it continuously, every 21 days as a cycle.
~Use until intolerable toxicity or disease progression occurs."
15730443|NCT05020951|Other|Medidata RAVE|Data collection done exclusively through Medidata Rave. Medidata Rave is a clinical data management system being used for data collection for this trial/study. Access to the trial in Rave is controlled through the CTEP-IAM system and role assignments.
15730444|NCT05020938|Other|phone survey|A questionnaire about the current symptoms and satisfaction for received treatment will be conducted over the phone for patients.
15730445|NCT05020925|Drug|SHR-1701|Intravenous (IV) on Day 1 of each cycle
15730446|NCT05020925|Drug|Famitinib|Famitinib, po, qd
15730447|NCT05020912|Drug|ALA|At first visit, ALA applied to one BCC lesion
15730448|NCT05020912|Procedure|PDT|PDT with blue light (for 30 min (~20 mJ/cm2))
15730449|NCT05020899|Behavioral|Sessions with a trained counselor|4 sessions will be provided with a trained counselor who will discuss the participant's' smoking habits with them and strategies to help them quit. The first session is in-person, lasts for 20 minutes, and typically happens when the participant comes to the HIV clinic to pick up their medication. Sessions 2 through 4 are over the telephone and last for 15 minutes each. These occur 1 week, 4 weeks, and 8 weeks after the first session.
15730450|NCT05020899|Other|Cell phone messages|Brief messages that give tips to help quit smoking will be sent to participants' cell phones using WeChat. 3 messages per day will be sent for the first week, 2 messages per day for the next 3 weeks, 1 message per day for the next 1 week, and 1-2 messages per week for the rest of the time
15730451|NCT05020899|Other|Offered nicotine replacement therapy|Participants will be offered nicotine replacement therapy (gum or patch, depending on which one is available).
15730452|NCT05020899|Other|Self-help guide for quitting smoking|Participants will be offered a self-help guide with information about quitting smoking.
15730453|NCT05020886|Behavioral|turning task|Several trials included bilateral turning in 30, 60, 90, 120, 150, 180 degree.
15730454|NCT05020873|Other|Crizanlizumab|Prospective observational study. There is no treatment allocation. Patients administered crizanlizumab, that have started before inclusion of the patient into the study will be enrolled.
15730455|NCT05020860|Drug|Paclitaxel|80 mg/m2 IV administered on days 1, 8, 15 of each 21-day cycle
15730456|NCT05020860|Drug|Carboplatin|Carboplatin AUC 1.5 IV administered on days 1, 8, 15 of each 21-day cycle
15730457|NCT05020860|Drug|Trastuzumab|Trastuzumab 8 mg/kg loading dose, followed by 6 mg/kg maintenance dose, administered on day 1 of each 21-day cycle
15730458|NCT05020860|Drug|Pertuzumab|Pertuzumab 840 mg loading dose, followed by 420 mg maintenance dose, administered on day 1 of each 21-day cycle
15730459|NCT05020860|Drug|Doxorubicin|60 mg/m2 IV administered on day 1 of each 14-day cycle
15730460|NCT05020860|Drug|Cyclophosphamide|600 mg/m2 IV administered on day 1 of each 14-day cycle
15730461|NCT05020847|Dietary Supplement|Standard F75|F-75 contains 75 kcal and 0.9 g protein per 100 ml
15730462|NCT05020847|Dietary Supplement|Alternative F75 with CMV|Alternative F75 With CMV contains cereal flour, oil, sugar, powdered milk with complex mineral-vitamin (CMV)
15730463|NCT05020847|Dietary Supplement|Alternative F75 without CMV|Alternative F75 without CMV contains cereal flour, oil, sugar, powdered milk without complex mineral vitamin (CMV).
15730464|NCT05020834|Other|Functional Electrical Stimulation|Functional Electrical Stimulation Group received 1.5 hours of conventional physical therapy program /session - 3 sessions weekly - three successive months + 1/2 hour of the gait training program with functional electrical stimulation /session - 3 sessions weekly - three successive months.
15730465|NCT05020834|Other|TheraTogs Orthotic Undergarment|TheraTogs Arm The participating children worn TheraTogs orthotic undergarment and strapping as preparatory stage without application of any exercise program with gradually increasing the worn time till reaching the 8 hours per day.
15730466|NCT05020821|Procedure|Single-shot interscalene block with intravenous dexmedetomidine|During surgery, dexmedetomidine will be administered. After intravenous administration of 2 mcg/kg for 30 minutes, 5 mcg/kg/hr will be administered until the end of surgery. After surgery, a single-shot interscalene brachial plexus block will be performed under ultrasound guidance. 15 mL of 0.5% ropivacaine with 1:200,000 epinephrine will be administered.
15730624|NCT05019534|Drug|Camrelizumab|Camrelizumab 200mg Q2W
15730467|NCT05020821|Procedure|Continuous interscalene brachial plexus block|Continuous interscalene block will be performed under ultrasound guidance and utilize patient-controlled analgesia infusion pump with a 300 mL reservoir of ropivacaine 0.2%, and programmed the pump to deliver 6 mL per hour with an optional patient-controlled analgesia bolus of 4 mL at 30-minute lockout intervals. Patients were typically discharged home on POD 1, and block was continued until reservoir completion.
15730468|NCT05020808|Dietary Supplement|NEAA|Food grade mixture of non-essential amino acids in powdered form to be dissolved in water. Supplied by Marigot Ltd, Cork, Ireland
15730469|NCT05020808|Dietary Supplement|PPI|Food grade plant (legume - Fava) protein isolate to be dissolved in water. Supplied by Marigot Ltd, Cork, Ireland
15730471|NCT05020782|Drug|Belimumab|INTERVENTION DRUG: BELIMUMAB 10 MG/KG
15730472|NCT05020769|Drug|SI-B001|Administration by intravenous infusion
15730473|NCT05020756|Dietary Supplement|Isosource Junior Mix|Single arm study, collecting data on those who have been on Isosourcr Junior mix tube feed formula for 30 days
15730474|NCT05020743|Other|No intervention|Not applicable for a Natural History Study
15730475|NCT05020730|Drug|PTM-001|PTM-001 (400 mg) every day for 12 weeks
15730476|NCT05020730|Drug|Placebo|Matching placebo every day for 12 weeks
15730477|NCT05020704|Drug|Empagliflozin 10 MG|SGLT2inhibitor
15730478|NCT05020704|Drug|Placebo|Matched placebo
15730479|NCT05020678|Biological|NKX019|NKX019 is an investigational allogeneic CAR NK product targeting CD19 on cells. The starting dose of NKX019 in Part 1 is 3 × 10^8 NK cells (2 × 10^6/kg for patients < 50 kg) administered as 3 weekly doses. Part 2 will use the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of NKX019 as determined in Part 1.
15730480|NCT05020665|Drug|Entospletinib|Orally as tablets
15730481|NCT05020665|Drug|Placebo|Orally as tablets
15730482|NCT05020665|Drug|Cytarabine|Continuous infusion
15730483|NCT05020665|Drug|Anthracycline|Either daunorubicin or idarubicin will be administered via slow intravenous (IV) push
15730484|NCT05020652|Drug|TQ05105 tablets|TQ05105 tablet is a JAK2 inhibitor, which can be used to treat JAK2 target related diseases, such as moderate or high-risk multiple myelofibrosis.
15730485|NCT05020652|Drug|Hydroxycarbamide tablets|Hydroxycarbamide tablet is a nucleoside diphosphate reductase inhibitor.
15730486|NCT05020639|Drug|TQB3820 tablets|TQB3820 is a novel cereblon-modulating agent.
15730487|NCT05020613|Procedure|Procedure: Early removal group|Participants assigned this arm will have their urethral catheters removed at 2 days after low anterior resection of the rectum
15730488|NCT05020613|Procedure|Procedure: Late removal group|Participants assigned this arm will have their urethral catheters removed after 48.th hours after Low anterior resection of the rectum
15730489|NCT05020600|Drug|Duloxetine|First-line fibromyalgia treatment
15730491|NCT05020574|Drug|Cephalexin|Given orally (PO)
15730492|NCT05020561|Behavioral|Group life-coaching|"Group coaching sessions will be focusing on providing material and tools that guide the participants in the transition from cancer treatment to survivorship. All activities of the group session will be following the After Cancer Passport document."
15730493|NCT05020561|Behavioral|Individual life-coaching|In the individual coaching sessions, the life-coach will provide guidances that help the participants to put tools into actions. All activities are outlined in the After Cancer Passport. Participants will use their Passport for each individual coaching session to outline their objectives and indicators of success. The life coach will also assign activities, such as self-reflection, for the participants to complete between each session.
15730494|NCT05020548|Other|peak inspiratory pressure 10 cmH2O|pressure controlled mask ventilation with peak inspiratory pressure of 10 cmH2O
15730495|NCT05020548|Other|peak inspiratory pressure 15 cmH2O|pressure controlled mask ventilation with peak inspiratory pressure of 15 cmH2O
15730496|NCT05020548|Other|peak inspiratory pressure 20 cmH2O|pressure controlled mask ventilation with peak inspiratory pressure of 20 cmH2O
15730497|NCT05020535|Drug|MW189|MW189 (0.25 mg/kg) is administered within 24 hours of symptom onset and every 12 hours for up to 5 days (10 total doses) or until discharge (if earlier than 5 days)
15730498|NCT05020535|Other|Saline|Administration of saline within 24 hours of symptom onset and every 12 hours for up to 5 days (10 total doses) or until discharge (if earlier than 5 days)
15730499|NCT05020522|Diagnostic Test|Luminal Index MRI (LI-MRI)|Multiecho T2 sequence; eventual biopsy of lesion(s) detected with LI-MRI only.
15730500|NCT05020522|Diagnostic Test|LI-MRI targeted prostate biopsy|Biopsy targeted to suspicious lesions detected with LI-MRI only
15730501|NCT05020522|Diagnostic Test|Plasma methylation signature (ctMethSig)|Blood sample.
15730502|NCT05020509|Procedure|medial branch block|lumbar medial branch block
15730504|NCT05020483|Drug|FEIBA|Administered via the central line catheter after termination of cardiopulmonary bypass if bleeding related to poor clotting develops; in addition, according to conventional protocol blood products will be transfused simultaneously. Three small doses, 5 mg/kg each, will be available.
15730505|NCT05020483|Drug|Placebo|Contains no active ingredient and administered via the central line catheter after termination of cardiopulmonary bypass if bleeding related to poor clotting develops; in addition, according to conventional protocol blood products will be transfused simultaneously.
15730506|NCT05020470|Device|Virtual Auricular Point Acupressure (APA)|Participants will learn how to self-administer APA by themselves.
15730507|NCT05020470|Other|In-Person Training|Participants will receive in-person training to self-administer APA.
15730508|NCT05020470|Other|Usual Care|Participants will continue to do whatever they are instructed by theirs physicians.
15730509|NCT05020457|Drug|SI-B001|I.V injection
15730510|NCT05020444|Drug|TriPRIL CAR T Cells|Intravenous infusion
15730511|NCT05020444|Drug|Cyclophosphamide|Intravenous infusion
15730512|NCT05020444|Drug|Fludarabine|Intravenous infusion
15730625|NCT05019521|Drug|Danicopan|Oral tablet.
15730626|NCT05019521|Drug|Placebo|Oral tablet.
15730513|NCT05020431|Other|Biological measuring of collagen fragments biomarker during orthodontic tooth movement|Biological measure the levels of type I collagen fragments ICTP and CTX levels in the GCF and saliva during initial leveling and alignment in adolescent patients treated with fixed orthodontic appliances.
15730514|NCT05020418|Other|Chart Review|Intervention sites will receive a multi-faceted implementation intervention, which will include external and internal blended facilitation, education materials for providers and patients, and audit and feedback about practices and outcomes with benchmarking to non-intervention sites.
15730515|NCT05020405|Procedure|Immediate implant placement and ARS with GBR and SMV|Implant insertion and GBR for augmentation of the gap between buccal and lingual plate using bone graft mixed with SMV
15730516|NCT05020405|Procedure|Immediate implant placement and ARS with GBR|Implant insertion and GBR for augmentation of the gap between buccal and lingual plate
15730519|NCT05020379|Procedure|Perioperative and postoperative multimodal analgesia|"Patients will receive standard multimodal analgesia comprising paracetamol, tenoxicam, and tramadol.
~The pain intensity during rest and motion will be evaluated with the 0-10 Numeric Rating Scale (NRS). NRS scores for pain and postoperative opioid consumption will be evaluated at 15th and 30th minutes, 1st, 2nd, 6th, 12th, 24th hours, 2nd day."
15730520|NCT05020379|Procedure|ESP Block|Patients in the ESPB group will be placed in a sitting position. A convex probe ultrasound transducer will be placed in a longitudinal parasagittal orientation approximately 3 cm lateral to the spinous process. Local anesthetic (20 ml 0.25% bupivacaine) will be injected bilaterally into the fascial plane on the deep face of the erector spinae muscle. Standard perioperative and postoperative analgesia protocol will be given and postoperative pain levels will be determined by Numerical Rating Scale (NRS). NRS scores for pain and postoperative opioid consumption will be evaluated at 15th and 30th minutes, 1st, 2nd, 6th, 12th, 24th hours, 2nd day.
15730521|NCT05020366|Behavioral|Preventing Obesity through Parent Empowerment and the Activation of Routines|Parents will receive a report of their child's current performance and adherence to World Health Organization recommendations in each intervention area. Parents will be coached to build consistent family mealtime routines, in which children are involved in meal preparation, food exploration, and play. They will receive education on appropriate serving sizes for young children and basic information nutrition recommendations. Predictable bedtime routines will be designed to incorporate calming sensory input to improve the transition to bed. Parents will be educated on screen time recommendations and help families brainstorm alternatives to screens, including family-based routines of movement and activity. Finally, parents will be coached to incorporate play into all newly adopted routines, as young children learn though play.
15730522|NCT05020366|Behavioral|Enhanced Usual Care|For the control group, usual care will be enhanced by providing parents with a report of their child's performance and adherence to World Health Organization recommendations in the areas of healthy eating, physical activity, sedentary behavior and sleep. This report will consolidate data based on parent report, written logs, and actigraphy at baseline.
15730523|NCT05020353|Device|OraQuick® HIV Self-Test|OraQuick® HIV Self-Test in oral fluid conducted by observed intended users (non-healthcare professional and inexperienced in HIV self-testing) compared to laboratory 4th generation Ag/Ab enzyme immunoassay (EIA) results performed on venous blood.
15730524|NCT05020340|Procedure|External cephalic version|In the intervention group, ECV will be performed by two operators with one of them having experience of ≥ 5 successful ECV. The procedure will be performed by the first operator under real time continuous ultrasonographic guidance. The fetal head and buttock will be grasped by both hands and attempt to rotate the fetus to a longitudinal lie either in a clockwise or anti-clockwise fashion. The second operator will perform the ECV if the first operator fails the procedure.
15730525|NCT05020327|Drug|Graded Oral Amoxicillin Challenge|Oral amoxicillin at 45 mg/kg (maximum of 1000 mg) to be divided into two doses: 10 % initial dose and then 90% remaining dose - doses will be separated by 30 minute interval
15730526|NCT05020327|Other|De-labelling in electronic medical record|Patients with No Risk for allergic reaction will be de-labelled for allergy in the electronic medical record.
15730527|NCT05020327|Other|Referral to Allergy Immunology/Retention of Allergy Label|Patients deemed to be High Risk for allergic reaction will be referred to Allergy Immunology as outpatient and allergy label will be retained.
15730528|NCT05020314|Behavioral|Healthy Weight Clinic|Patients meet with a multi-disciplinary team over a 12 month period. In addition to the clinical visits, group visits, and phone calls, patients will also receive education materials, community resources, and an optional text messaging/social media library of messages.
15730529|NCT05020301|Device|external meditation guided audio|Examining DMN connectivity and CSF flow in external meditation state by External Meditation Instruction Audio.
15730530|NCT05020301|Device|internal meditation guided audio|Examining DMN connectivity and CSF flow in external meditation state by Internal Meditation Instruction Audio.
15730531|NCT05020288|Drug|Orelabrutinib|Orelabrutinib 50mg po qd, every four weeks for one cycle. It will be given three cycles.
15730532|NCT05020275|Diagnostic Test|Blood Samples|"Samples for ctDNA blood concentration and osimertinib plasma concentration
~Sample for genetic polymorphisms"
15730533|NCT05020262|Other|CT Image reconstruction|Retrospectively collects CT Images and reconstruct using PI/PC and Idose4/Cardiac Images to assessment the performance of the two new software functions of Incisive CT. No direct intervention to patients. And ICF is exempted by EC.
15730534|NCT05020249|Drug|bimekizumab|Study participants will receive bimekizumab administered through subcutaneous injection in a pre-specified sequence during the Treatment Period.
15730535|NCT05020249|Other|Placebo|Study participants will receive placebo administered through subcutaneous injection in a pre-specified sequence during the Treatment Period.
15730540|NCT05020223|Other|Vital pulp therapy|Vital pulp therapy different modalities for management of deep carious lesion in primary teeth
15730541|NCT05020210|Drug|Sivelestat sodium|Patients were treated with Sivelestat Sodium within 72 hours of the diagnosis of ARDS.
15730542|NCT05020197|Diagnostic Test|self-questionnaires on attachment and PTSD|The questionnaires (attachement type, PTSD symptoms) are administered face to face at the inclusion visit (at D0-D3). Validated self-questionnaires in French will be sent to the patients, either electronically or by post, according to their choice at D30 and D90. To describe the characteristics of the subjects, socio-demographic data, lifestyle, and medical history will be collected. The questionnaires will be administered three times to study the evolution of the parameters over time.
15730543|NCT05020184|Drug|Cimetidine|Oral Cimetidine 800mg twice daily.
15730544|NCT05020184|Drug|Placebo|Placebo twice daily
15730545|NCT05020171|Device|Group of strength training|2x a week during 5 weeks, strengthening of weak muscles with the intensity recommended in the literature, i.e. 3-4x15 repetition at an intensity of 50 to 80% of the maximum force combined with serious games to stimulate patient involvement in strength training
15730546|NCT05020171|Other|Group of physiotherapy not focus on strength training|2x a week during 5 weeks, active physical therapy treatment based on movement
15730547|NCT05020158|Other|Family Talk Intervention|A psychosocial family-based intervention that is designed to give support to an entire family when a child has life-threatening illness.
15730548|NCT05020145|Biological|BNT162b2 (Tozinameran)|Covid-19 Vaccine
15730549|NCT05020119|Drug|Neoantigen-expanded cell therapy.|Infusion of personalized neoantigen-expanded T (CIK) cells
15730550|NCT05020093|Procedure|Injection molding|preheated bilk-fill composite, co-cured universal adhesive, David Clark cavity design
15730551|NCT05020093|Procedure|Incremental packing|Incremental packing of conventional composite; pre-cured universal adhesive, non-beveled cavity design
15730552|NCT05020080|Other|Operant conditioning of motor evoked potentials|MEPs elicited by TMS will be applied at the hot spot for the wrist extensor carpi radialis. During training trials, participants will be asked to increase the size of their MEP response. During assessment trials, a physical therapist or occupational therapist will rate the functional level of arm impairment using FMA and ARAT.
15730553|NCT05020067|Radiation|superficial parotid lobe-sparing intensity-modulated radiotherapy|The superficial parotid lobe was contoured as an OAR, and V26 (the percentage volume receiving 26 Gy or more) in the superficial parotid lobe was constrained to be less than 30%.
15730554|NCT05020054|Device|Tecartherapy Intervention|therapeutic therapy with effective application, connected equipment
15730555|NCT05020054|Device|placebo tecartherapy|tecartherapy with equipment turned off
15730556|NCT05020041|Behavioral|Physical activity|"The schools in the intervention group will receive the online educational talk aimed at schoolchildren and a talk aimed at Physical Education teachers, given that they are fundamental for the development of habits in the school stage; besides, painted games will be implemented in the school playground.
~The implementation of painted games will consist of adapting a space destined for recreation, designing a psychomotor circuit that does not require contact between peers or manipulation of objects in order to maintain COVID-19 sanitary and safety protocols. The psychomotor circuit includes a line circuit, a jumping sequence game, and a letter spiral. All the games will be implemented in a space within the educational establishment to which the students will have access during recess. The game designs involve activities to develop motor patterns such as jumping with different supports, running, and dynamic balance."
15730557|NCT05020028|Drug|Cannabidiol (CBD)|Subjects will be dispensed enough 25mg cannabidiol (CBD) Orally Disintegrating Tablets (ODT) for a standard dose (50mg) of every 4-6 hours for 14 days.
15730558|NCT05020028|Drug|Placebo|25mg Placebo ODT looks like the cannabidiol (CBD) Orally Disintegrating Tablets (ODT), but contains no active ingredients.
15730559|NCT05020015|Biological|TAK-007|TAK-007 intravenous injection.
15730560|NCT05020015|Drug|Chemotherapy Agents|Fludarabine and cyclophosphamide as per standard of care.
15730561|NCT05019989|Behavioral|Intervention group on diet and physical activity|"The intervention wanted to increase physical activity, controlling weight, promoting healthy diet.
~Physical activity: achieve and maintain regular participation in a moderate intensity physical activity program of 210 minutes/week (30 min on average per day) over at least 3 days /week; decrease sedentary behaviors by 30 minutes/day on at least 5 days/week
~Weight control: reducing energy intake relative to expenditure is the primary dietary focus for promoting weight loss in overweight or obese participants, and maintaining a healthy energy balance is the primary focus for normal weight participants. Participants will be encouraged to include whole grains and high-fiber vegetables
~Healthy diet: reducing calorie intake, through the preferred consumptions of unrefined cereals, pulses and vegetables, reducing high glycemic index food and high insulinemic foods, such as sugar and milk; reducing sources of saturated fat and animal protein (except fish)"
15730562|NCT05019989|Behavioral|Control group: only public recommendation an lifestyle|"Invitation leaflet, explaining the rationale of the study and including basic life-style recommendations, based on the 1997 World Cancer Research Fund recommendations (to be updated in 2007) and the Italian National Institute of Nutrition food pyramid.
~Dissemination of the information on the study by media
~Yearly follow-up questionnaire on breast events and dietary and physical activity chang"
15730563|NCT05019976|Radiation|Radiation - Dose Level 0|"Dose Per Fraction (Each Radiation Treatment): 3.2Gy to 2.4Gy (minimal dose) depending on what study doctor prescribes
~Total Dose of Radiation for Treatment Period: 44.8Gy to 33.6Gy (minimal dose) depending on what study doctor prescribes
~Total Number of Radiation Treatments: 14"
15730564|NCT05019976|Radiation|Radiation - Dose Level 1|"Dose Per Fraction (Each Radiation Treatment): 4.2Gy to 3.2Gy (minimal dose) depending on what study doctor prescribes
~Total Dose of Radiation for Treatment Period: 42Gy to 32Gy (minimal dose) depending on what study doctor prescribes
~Total Number of Radiation Treatments: 10"
15730565|NCT05019976|Radiation|Radiation - Dose Level 2|"Dose Per Fraction (Each Radiation Treatment): 5.2Gy to 4.2Gy (minimal dose) depending on what study doctor prescribes
~Total Dose of Radiation for Treatment Period: 39.2Gy to 29.4Gy (minimal dose) depending on what study doctor prescribes
~Total Number of Radiation Treatments: 7"
15730566|NCT05019976|Radiation|Radiation - Dose Level 3|"Dose Per Fraction (Each Radiation Treatment): 6.8Gy to 5.4Gy (minimal dose) depending on what study doctor prescribes
~Total Dose of Radiation for Treatment Period: 34Gy to 27Gy (minimal dose) depending on what study doctor prescribes
~Total Number of Radiation Treatments: 5"
15730676|NCT05019118|Other|Experimental yogur|UNICLA yogur naturally enriched in selenium and omega-3.
15730567|NCT05019976|Radiation|Radiation - Dose Level 4|"Dose Per Fraction (Each Radiation Treatment): 10Gy to 7.8Gy (minimal dose) depending on what study doctor prescribes
~Total Dose of Radiation for Treatment Period: 30Gy to 23.4Gy (minimal dose) depending on what study doctor prescribes
~Total Number of Radiation Treatments: 3"
15730570|NCT05019950|Drug|LABP-104 250mg|"Dose escalation in the SAD part of the study (Part A) will be conducted in 5 cohorts (Cohorts 1 to 5). Seven participants will be enrolled in each cohort and randomized to receive either LABP-104 or placebo (ratio 5:2). LABP-104 will be administered to Cohort 1 participants at the starting dose of 250 mg and increased in each new cohort (500 mg, 750 mg, 1000 mg, 1500 mg).
~It is anticipated that 3 dose levels will be evaluated in Part B in a total of 3 cohorts (Cohorts 6 to 8). Seven participants will be enrolled in each cohort and will be randomized to receive a single oral dose of either LABP-104 or placebo (ratio 5:2), once daily for seven days. LABP-104 dose levels to be evaluated in Part B will be 250 mg, 500 mg, and 1500 mg."
15730571|NCT05019950|Drug|Placebo|"Dose escalation in the SAD part of the study (Part A) will be conducted in 5 cohorts (Cohorts 1 to 5). Seven participants will be enrolled in each cohort and randomized to receive either LABP-104 or placebo (ratio 5:2). LABP-104 will be administered to Cohort 1 participants at the starting dose of 250 mg and increased in each new cohort (500 mg, 750 mg, 1000 mg, 1500 mg).
~It is anticipated that 3 dose levels will be evaluated in Part B in a total of 3 cohorts (Cohorts 6 to 8). Seven participants will be enrolled in each cohort and will be randomized to receive a single oral dose of either LABP-104 or placebo (ratio 5:2), once daily for seven days. LABP-104 dose levels to be evaluated in Part B will be 250 mg, 500 mg, and 1500 mg."
15730572|NCT05019937|Behavioral|Educational meeting|The investigators will hold a full-day educational meeting. The meeting will include educating 4-5 representatives of each school, and school-district representatives about the guideline and the advantages of adhering to the guideline.
15730573|NCT05019937|Behavioral|Implementation team|The school-principal forms an implementation team that is responsible for implementing the guideline within their school. The team members (n=4-5) reflect on the implementation progress, make, and refine plans according to Plan-Do-Study-Act, share lessons learned and support each other.
15730574|NCT05019937|Behavioral|Workshops|"The investigators will hold 5 workshops. Workshops will include providing in-depth knowledge and skills on the guideline recommendations. During each workshop one of the guideline recommendations will be presented and discussed.
~Moreover, the concept of Plan-Do-Study-Act will be introduced and how it can be used to implement the guideline recommendation(s). During each workshop, the implementation team will share with the group their developed PLAN and barriers and facilitators that have influenced the execution of the PLAN."
15730575|NCT05019937|Behavioral|Plan-Do-Study-Act improvement cycles|The implementation team will implement the guideline in a cyclical manner by using Plan-Do-Study-Act. First a Plan is specified during the workshop by using SMART-goals, next the change is carried out between workshops (Do), the implementation team analyses whether it went well and what needs to be improved (Study), changes are made (Act) and finally the next cycle is planned.
15730576|NCT05019937|Behavioral|Internal facilitator|Each municipality assigns one or more internal facilitators, for example HR-strategist. The internal facilitator will meet their local implementation teams during the educational meeting and workshops. Further meeting can be scheduled based on the needs of each implementation team. The internal facilitator will create a supportive environment within which knowledge is exchanged, barriers to implementation identified, and processes or solutions to overcome those barriers developed, applied, and refined. Moreover, the internal facilitator will establish ongoing audit and feedback processes.
15730577|NCT05019924|Dietary Supplement|Semaine|The dietary supplement is designed, and marketed commercially to be taken in servings of two capsules per day, up to four times per day (a total of 8 capsules daily). Most consumers, however, will only take a serving three times per day, or one with each major meal (breakfast, lunch and dinner).
15730578|NCT05019911|Device|Polysomnography|In the cross-sectional part, the group of patients with COPD alone and the group of patients with COPD combined with sleep apnea hypopnea syndrome will be monitored by traditional sleep monitoring equipment (polysomnography) for vital signs in order to diagnose COPD combined with sleep apnea hypopnea syndrome.
15730579|NCT05019911|Device|Millimeter wave radar equipment|In the cross-sectional part, the group of patients with COPD alone and the group of patients with COPD combined with sleep apnea hypopnea syndrome will be monitored by millimeter wave radar equipment for vital signs in order to diagnose COPD combined with sleep apnea hypopnea syndrome. In the cohort part, both groups of patients will be continuously monitored by millimeter wave radar equipment for vital signs for months in order to establish a model to predict acute exacerbations of COPD combined with sleep apnea hypopnea syndrome.
15730580|NCT05019898|Diagnostic Test|pupillometry|"Step 1: The triage will be carried out by the nurse. The nurse will then perform a self-assessment of the patient's pain using a simple verbal scale.
~The nurse will then record the patient's self-assessment of his pain using the numeric scale for pain.
~Step 2: Immediately after this first assessment, eligible patients will be approached by the study investigator to be included in the study.
~Step 3: If the patient gives informed consent, the study investigator will perform
~The quantification of their anxiety
~An assessment of pain by a NeuroLight videopupillometer (iDmed, Marseille, France) using two dynamic tests, the Pupillary Unrest in Ambient Light (PUAL) and the pupillary light reflex.
~Step 4: One hour after the triage, a second pain assessment will be performed. Step 5: The same pupillometry measurements will be taken immediately after the nurse has assessed the pain."
15730583|NCT05019859|Behavioral|low carb diet|low carb diet
15730584|NCT05019846|Drug|Triptorelin Embonate|single administration before SRT starting
15730585|NCT05019846|Drug|Bicalutamide 50 mg|1 dose each day, 7 days before LHRH until 10 days after LHRH administration
15730586|NCT05019833|Device|Signals collection|A non-CE marked embedded software will be temporarily uploaded in the implanted device, in order to enable the collection of sensors signals.
15730765|NCT05018338|Device|Brain shift monitoring|For use to monitor brain shift during craniotomy
15730587|NCT05019820|Other|Knee strengthening exercises with isokinetic dynamometer|18 sessions of strengthening exercises around the knee with an isokinetic dynamometer 3 days a week
15730588|NCT05019820|Other|Strengthening around the knees with home exercise programe|18 sessions of strengthening exercises for the muscles around the knee at home, 3 days a week
15730589|NCT05019807|Other|WhatsApp group|Patients under intervention group will attend an education sessions by structured videos and images with the help of digital tool-WhatsApp group chat administered by the researcher. The group will have the objective interaction with patients and researchers to convey about their view of opinion on sight threatening diabetic retinopathy and management. The structured programme included definition of diabetes mellitus, symptoms, risk factors, awareness of DM and DR, importance of self-care about the disease (eye care and blood glucose monitoring), dietary management and importance of physical activity (Life style modification). The groups will be tracked frequently by WhatsApp/telephonic call and will be documented. Confidentiality of all participants will be maintained.
15730590|NCT05019807|Other|Control group|Patient under non-intervention group will not attend or take part in the education sessions or interaction with other patients. Will receive only the general instructions or advises from ophthalmologists about management and follow-up visit.
15730591|NCT05019794|Drug|Infigratinib|Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.
15730592|NCT05019781|Other|Therapeutic tape|Tape was applied to sternocleidomastoid, upper trapezius, deltoid, flexor palmaris longus muscles as suggested by Kase et al. (Kase, Wallis, Kase, & Association, 2003). The tape was applied to the left side of the participants while sitting position because the violin is traditionally played by placing it on the left shoulder, balancing the neck using the left hand, and bowing with the right arm.
15730593|NCT05019781|Other|Placebo tape|The placebo tape was applied transverse to the muscle groups in two levels (a point of 10 cm above to wrist and elbow) with no tension when the participants were sitting position with the shoulder flexed at 90°, and the elbow flexed at 90°.
15730594|NCT05019768|Other|accelerated custom-fast CXL|The accelerated custom fast CXL (aCFXL) has been developed on a published mathematical model that takes into consideration objective variables such as the equation governing the UVA-induced riboflavin consumption rate and the corneal thickness at its thinnest point. By knowing both values, the mathematical model allows to objectively calculate both the exact UVA irradiation value (intensity), expressed in mW/cm2, and the irradiation time
15730595|NCT05019768|Other|Standard CXL|The standard CXL procedure has been carried on following the Dresden protocol
15730596|NCT05019755|Drug|IN-A002(IN-115314) capsule|Oral Administration of IN-A002(IN-115314), single dose
15730597|NCT05019755|Drug|IN-A002(IN-115314) capsule|Oral Administration of IN-A002(IN-115314), single dose
15730598|NCT05019742|Drug|SPH3127|SPH3127 - selective renin inhibitor
15730599|NCT05019742|Drug|Placebo|Placebo
15730602|NCT05019716|Drug|BET Bromodomain Inhibitor ZEN-3694|Given PO
15730603|NCT05019716|Drug|Cisplatin|Given IV
15730604|NCT05019716|Drug|Etoposide|Given IV
15730605|NCT05019703|Biological|Atezolizumab|Given IV
15730606|NCT05019703|Drug|Cabozantinib|Given PO
15730607|NCT05019690|Drug|Apatinib Mesylate|Subjects receive Apatinib orally, Dosage form: tablet, Strength: 250 mg/tablet,QD,Q3W
15730608|NCT05019690|Drug|Albumin-Bound Paclitaxel|Subjects receive Albumin-Bound Paclitaxel,ivgtt, Strength: 125 mg/m^2,d1、7、15,Q3W
15730609|NCT05019677|Drug|GP+PD-1+Tight|"Drug: Tislelizumab Tislelizumab 200mg IV Q3W
~Other Name:
~BGB-A317 Anti-PD-1 therapy
~Drug: Ociperlimab Ociperlimab 900mg IV Q3W
~Other Name:
~BGB-A1217 Anti-TIGIT therapy
~Drug: GP chemotherapy gemcitabine 1000mg/m2 + cisplatin 25mg/m2 Q3W"
15730610|NCT05019664|Device|Humeral fracture nailing|inramedullary nailing designed for fixation and stabilization of fractures or osteotomies of the humerus
15730611|NCT05019651|Device|Apollo Wearable System|Participants will be provided with the Apollo wearable device and asked to install the study mobile application on their mobile phone. Participants will use the Apollo for at least 30 minutes after waking up in the morning and at least 30 minutes before bed on the corresponding settings for those times of day. They will be given the Apollo Device TVS (10-200 Hz) to borrow which they will be instructed to wear for 6 +/- 2 weeks. They will be asked to continue to wear the device until all study data is collected.
15730612|NCT05019638|Drug|Regional anesthesia group|bupivacaine 0.25% with epinephrine 1:400,000.
15730613|NCT05019638|Drug|Local multimodal analgesia group|5mg of morphine, 500 mg of epinephrine, 15mg of ketorolac, and 20mg of bupivacaine.
15730614|NCT05019612|Procedure|Laparoscopy: A minimal invasive surgery|A low-risk minimal invasive surgery performed in the pelvis using small incisions. With the aid of a laparoscope, the operator views the affected area in real-time. Beyond that, the camera sends images to a video monitor. The operator obtains endometriosis and biopsy samples with small surgical instruments. Before laparoscopy, individuals are provided with a general anaesthetic to relax muscles and prevent pain during surgery.
15730615|NCT05019599|Other|low protein diet|Low protein diet (<0.8g/kg/BW/day)
15730616|NCT05019586|Drug|levofloxacin, amoxicillin, clarithromycin|Triple therapy of Helicobacter pylori including two antibiotics and a proton inhibitor for 10 days
15730617|NCT05019573|Dietary Supplement|Black tea|Black tea twice a day for 4 weeks
15730618|NCT05019573|Dietary Supplement|Placebo|Placebo tea twice a day for 4 weeks
15730619|NCT05019560|Drug|Sevoflurane|IFT response, hemodynamics and BIS value were recorded during intubation period. Then the data acquisition was stopped and the isolated forearm cuff deflated. IFT values were noted by two independent observers
15730620|NCT05019560|Drug|TIVA|IFT response, hemodynamics and BIS value were recorded during intubation period. Then the data acquisition was stopped and the isolated forearm cuff deflated. IFT values were noted by two independent observers
15730621|NCT05019547|Behavioral|Determining Barriers and Facilitators of Physical Activity|Determining Barriers and Facilitators of Physical Activity
15730622|NCT05019534|Drug|Vemurafenib Oral Tablet [Zelboraf]|Vemurafenib 960mg qd or 960mg bid (2 cohorts)
15730623|NCT05019534|Drug|Cetuximab Injection [Erbitux]|Cetuximab 500mg/m2 Q2W
15730628|NCT05019482|Behavioral|University-based intervention to promote PA and reduce ST|"This intervention was realized with all college student and involved:
~Design-based innovative workshops during the first week;
~8-weeks program of Physical Activity constructed by users
~Information session focusing on the promotion of active behaviors
~Feedback provided to the users with an individualized report"
15730629|NCT05019469|Device|Rhythmic vibration cueing (lower leg)|A non-invasive wearable device worn against both gastrocnemius muscles provides rhythmic vibrations when triggered.
15730630|NCT05019456|Biological|COVID-19 Vaccine|COVID-19 Vaccine (mRNA or J&J)
15730631|NCT05019443|Device|Wedge Scoring Balloon|Scoring balloon
15730632|NCT05019443|Device|Conventional Balloon|Conventional balloon
15730636|NCT05019417|Drug|Glycerol Phenylbutyrate 1100 MG/ML|Daily adminisitraion of the study drug (three times a day) in escalting dose over 4 months
15730637|NCT05019404|Procedure|Functional temporal lobectomy (FTL)|Patients are placed in the supine position with the head contralaterally rotated 30°. The 3D model of incision and bone flap is printed prior to surgery by the slicer software based on the MRI data. Straight incision with the length of about 7 cm in the temporal region is marked according to the 3D model. Temporal craniotomy via small bone window with the diameter of about 3 cm is performed. From the temporal pole along T1 about 5 cm posteriorly, temporal horn is opened by dissecting the superior temporal sulcus. The head of temporal horn is exposed. The amygdala is resected. Then, the parahippocampal gyrus and the head and body of hippocampus are en bloc resected. The lateral temporal lobotomy is easy due to large view following the removal of mesial structures. The lateral posterior temporal lobotomy is no more than 5 cm from the temporal pole.
15730638|NCT05019404|Procedure|Anterior temporal lobectomy (ATL)|Patients are placed in the supine position with the head contralaterally rotated 30°. Large frontotemporal craniotomy is performed. Question mark-shaped incision with the length of 20- 25 cm in the frontotemporal region is marked. The size of the bone flap is approximately 5×8 cm for the exposure of lateral temporal lobe. ATL consists of en bloc resection of the anterior 5 cm of lateral temporal lobe, followed by the removal of mesial structures including the amygdala, parahippocampal gyrus, and the head and body of hippocampus.
15730639|NCT05019391|Device|transcranial doppler|it provides an accurate, noninvasive, and simple method for the diagnosis of VBI. Through the diagnosis results, it will be clear about the blood flow status of single vessel and vascular compliance, which is helpful for accurate reflection of the subtle changes of VBI
15730640|NCT05019378|Procedure|SVF treatment|autologous SVF (10E8 cells)
15730641|NCT05019352|Device|CytoSorb cytokine adsorber|device for extracorporeal hemoadsorption
15730642|NCT05019352|Device|CRRT|continuous renal replacement therapy
15730643|NCT05019339|Behavioral|Healthy HomeStyles|Comparison of 2 educational interventions
15730644|NCT05019339|Behavioral|Eat Healthy Be Active|Comparison of 2 educational interventions
15730645|NCT05019326|Drug|Andrographis Paniculata|Andrographis extract, equivalent to andrographolide 20 mg per capsule, for a total of 180 mg of andrographolide per day, dosing into 3 capsules taking before meal for 3 times per day, for 5 days.
15730646|NCT05019326|Drug|Boesenbergia|Boesenbergia extract, equivalent to pinostrobin 30 mg per capsule, for a total of 180 mg of pinostrobin per day, dosing into 2 capsules taking after meal for 3 times per day for 5 days.
15730647|NCT05019326|Other|Standard supportive treatment|as recommended by guidelines from the Ministry of Public Health, Thailand. No antivirus was given.
15730648|NCT05019313|Device|Evaluation of diaphragmatic contractility by ultrasound|Lung ultrasound is performed during mechanical ventilation weaning. The diaphragmatic thickening fraction is evaluated positioning a linear probe in midaxillary line. Inspiratory and expiratory measurements are bilateral and are M-mode images. Right diaphragmatic thickening fraction has been considered as true and reproducible measurement.
15730649|NCT05019300|Biological|Exposure: COVID-19 severity|COVID-19 severity between 4 to 7 points according the seven-category scale of clinical status reported by Huang et al. (2021) and severe to critical symptomatic levels on spectrum of disease reported by Wu and McGoogan (2020).
15730650|NCT05019287|Biological|Allogeneic human menstrual blood stem cells secretome|This COVID-19 Study intervention consists of Intravenous Allogeneic human menstrual blood stem cell (MenSC) secretome injection in addition to standard care. The MenSC were characterized as CD90+, CD73+, CD105+, and CD45-based on multiparameter flow cytometry.
15730651|NCT05019287|Other|Intravenous saline injection|Intravenous saline injection in addition to standard care
15730652|NCT05019274|Other|Culinary Medicine Intervention|Participants randomized to the Culinary Medicine intervention will complete a series of 6 virtual culinary medicine cooking classes (1 class per month for 6 months). Virtual sessions will be delivered via Zoom using a combination of large group instruction and small group break-out sessions in which participants prepare a recipe in their home kitchen with the virtual assistance from trained group facilitators. After preparing the dish, participants will enjoy the dish they prepared and report-back to the large group about their dish and experience. Classes will be conducted in English and Spanish with language-concordant instructors and facilitators.
15730653|NCT05019274|Other|Standard of Care Nutrition Visits|Participants randomized to standard of care nutrition visits will complete a series of 6 nutrition visits (1 session per month for 6 months) led by bilingual (English/Spanish) dieticians. Sessions will consist of a mix of individual and small group sessions per standard of care in the clinic.
15730677|NCT05019118|Other|Experimental fresh cheese|UNICLA fresh cheese naturally enriched in selenium and omega-3.
15730678|NCT05019118|Other|Placebo milk|Conventional milk
15730679|NCT05019118|Other|Placebo yogur|Conventional yogur
15730680|NCT05019118|Other|Placebo fresh cheese|Conventional fresh cheese
15730654|NCT05019261|Other|Multi-component Family Support Intervention|The multi-component intervention is designed to enhance the quality of clinician-family communication and help families manage the emotional and cognitive complexities of surrogate decision-making. It involves: 1) proactive clinician-family meetings; 2) use by surrogates of an interactive web-based tool throughout the ICU stay which is narrated by family members of ICU patients and includes stories and experiences from other families, self-care strategies, brief videos explaining what to expect during family meetings, a question prompt list, an interactive values clarification exercise, and an explanation of different treatment pathways for critically ill patients. 3. Prior to the proactive family meetings, the ICU team is provided with a summary of the family's main questions/concerns, their prognostic expectations, a summary of the patient's values and preferences, and surrogates' current ratings of the extent to which their psychosocial needs are being addressed in the ICU.
15730655|NCT05019248|Biological|Most recent vaccine to seasonal influenza|Seasonal Influenza vaccine: according to the latest SmPC and according to national guidelines (published by the Standing Committee on Vaccination (STIKO)).
15730656|NCT05019222|Drug|Sevoflurane based inhalation anesthesia|Sevoflurane group will be inducted with bolus of propofol 1% and maintained with sevofulrane as inhalation and TCI Minto model of remifentanil for general anesthesia.
15730657|NCT05019222|Drug|Remimazolam based total intravenous anesthesia|Remimazolam group will be inducted with remiamazolam at 6 mg/kg/h and maintained with remimazolam at 0.5-1.5 mg/kg/h and TCI Minto model of remifentanil for general anesthesia.
15730658|NCT05019209|Drug|House Dust Mite Allergen|D. pteronyssinus lyophilisate dissolved in 5% sodium chloride solution, spray dried
15730659|NCT05019209|Other|Allergen-free air|No allergen added to room ventilation of allergen challenge chamber
15730660|NCT05019196|Device|GE 3.0T MRI|using GE 3.0T MRI to obtain anatomical and functional MR images and DTI images
15730661|NCT05019183|Other|Physical training|The subjects will perform 6 indoor rower sessions (30 min each, on Day 1, 2, 3, 8, 9 and 10) with a target heart rate zone of 60%.
15730662|NCT05019183|Other|Virtual reality|The subjects will be able to move freely in virtual environments while training on the indoor rower.
15730663|NCT05019183|Device|Single-photon emission computed tomography (SPECT)|SPECT allows the measurement of cerebral perfusion, reflecting the global synaptic activity, via a 3D acquisition of 20 minutes, 15 minutes after injection of 740 MBq of radiotracers (ECD - Neurolite or HMPAo - Cerestab), with iterative reconstruction. The data will be processed at the voxel scale by the SPM12 software, with analysis of brain connectivity.
15730664|NCT05019183|Biological|Metabolomics|This qualitative approach will aim to identify pathways that are not known (or have not been explored) to optimize the chances of detecting metabolites present depending on the group (physical activity coupled or not with VR). This method is favorable for biomarker discovery.
15730665|NCT05019170|Behavioral|Smartphone-based Financial Incentives|Financial Incentives - Beginning on the quit date and extending for one week, participants will be required to submit twice daily CO samples. All samples < 6 ppm will be considered negative and those > 6 ppm will be considered positive. Participants will earn incentives for breath tests indicating smoking abstinence, and incentive values will increase with each consecutive negative sample. Following the initial quit week, the schedule of monitoring will be reduced, and incentives will be contingent on submitting a negative saliva cotinine test.
15730666|NCT05019170|Behavioral|Best Practices|Best Practices- The 2008 Clinical Practice Guidelines for smoking cessation recommends that pregnant smokers be provided with the 5As. Research staff will implement the 5As at assessments that take place during pregnancy.
15730667|NCT05019157|Other|Telerehabilitation group|Participants will undertake the first three training sessions in the outpatient clinic for familiarization with the training modalities, the wearable sensors and the data uploading. Afterwards, the participants will proceed with the telerehabilitation program at their homes. The participants will be lent the wearable sensors and will undergo an exercise - based program 3 times/week, comprising of 10' warm up exercises, 40' aerobic, resistance, balance exercises and 10' cool down.Training sessions will be monitored, in real time, by the study investigator. Participants should upload the recorded data to Polar Flow web platform after every training session and should visit the outpatient clinic every month to upload the accelerometry's recorded data to a secure personal computer) application. Educational and informational videoconferences will be held every week for upright training exercise sessions, physical activity counseling, diet/nutritional and smoking cessation counseling.
15730668|NCT05019157|Other|Centre - based rehabilitation group|Participants will attend an exercise - based cardiac rehabilitation program at the outpatient clinic's facilities under the supervision of cardiac rehabilitation specialized staff. The participants will receive an individually tailored training program on a treadmill or a cycle ergometer. Total training attendance rate will be documented by the cardiac rehabilitation centre staff. Patients will be instructed to wear a tri - axial accelerometer during the entire 12 weeks study period. Participants should upload recorded data to the local server every month. Educational videoconferences will be held every week for physical activity counseling, diet/nutritional and smoking cessation counseling.
15730669|NCT05019144|Procedure|Face-to-face burn care|If the participants are assigned to FTF care, they will receive standard burn care including a return follow-up in the burn clinic on a routine basis as prescribed by the clinical burn team (at least once per week) until the burn has healed.
15730670|NCT05019144|Procedure|Telemedicine enhanced burn care|Participants assigned to TOBI will be given instructions how to download and use TOBI on a smartphone, including how to interface with burn clinicians using text-messaging, videoconferencing, and sending photos of the child's burn(s). The participants will have scheduled video visits with the care provider at least weekly until the burn has healed. The participants will be able to use other features of the app, such as text-messaging and sending photos of the burn(s), as needed. The participants will be able to use standard FTF burn care as well. They will be given instructions how to contact the burn team through the hospital paging operator if TOBI is unavailable or there is an emergency.
15730671|NCT05019131|Behavioral|Training|trainings to reduce conscious bias and stress
15730672|NCT05019131|Behavioral|Peer support and mentorship|facilitated peer and mentorship opportunities
15730673|NCT05019131|Behavioral|Leadership engagement|Engaged leadership at the county and facility levels
15730674|NCT05019131|Behavioral|Embedded champions|Facilitate local champions to promote intervention
15730675|NCT05019118|Other|Experimental milk|UNICLA milk naturally enriched in selenium and omega-3.
15730683|NCT05019092|Diagnostic Test|Ultrasound examination of lower limb veins|Ultrasound examination will be performed by trained physicians using a commercially available ultrasound system and 5.0-15.0 MHz linear probe. The examinations consists of a comprehensive B-mode ultrasound protocol, from thigh to ankle, employing compression and color-Doppler at selected sites, according to the Consensus Conference of the Society of Radiologists in Ultrasound.
15730684|NCT05019079|Other|electroacupuncture|In the electroacupuncture group, acupoints of Lieque (+), Chize (-), Sanyinjiao (-), Zusanli (+), Tanzhong (+) and Yutang (-) will be selected for electrical stimulation. Density wave will be selected, and the current intensity should be tolerated by the patients. Conventional anesthesia operation could be started after the connection of electroacupuncture, and acupuncture point stimulation will be stopped 30min later.
15730686|NCT05019053|Behavioral|Coping Crew|Coping Crew consists of five 60-minute virtual intervention sessions coinciding with five weeks of EMI. Participants will receive psychoeducation, challenge cognitive biases or mythbust, and participate in behavioral exposure and behavioral experiments. An EMI component of this treatment will be included for the purpose of treatment monitoring and homework tracking. Participation in this EMI component involves the daily report of levels of anxiety, depression, stress, and loneliness. When participants endorse elevated levels on any of these constructs, they will receive a targeted message reminding them of the topics covered in COPING CREW. One month after the intervention session, COPING CREW participants will complete follow-up questionnaires and interview. Participants will also participate in a feedback session 3 months after the intervention.
15730687|NCT05019040|Drug|PA1010|TDF as control
15730688|NCT05019027|Drug|Beta blocker|"The intervention is a single-arm crossover withdrawal/reversal design (On vs Off) with up to 4 total periods, each period lasting between 2-6 weeks. During the On period, subjects will be on their beta blocker. During the Off period, their beta blockers will be down titrated and subsequently discontinued.
~Other Names:
~atenolol
~betaxolol
~bisoprolol
~metoprolol
~nebivolol
~nadolol
~propranolol
~acebutolol
~penbutolol
~pindolol
~carvedilol
~labetalol
~sotalol
~metoprolol succinate
~metoprolol tartrate"
15730689|NCT05019001|Procedure|Laminoplasty|A posterior approach surgical method to treat patients with Ossification of the Posterior Longitudinal Ligament
15730690|NCT05019001|Procedure|Laminectomy With Fusion|Another posterior approach surgical method to treat patients with Ossification of the Posterior Longitudinal Ligament
15730691|NCT05018988|Dietary Supplement|Oral vitamin D spray|1 spray (10µg) /day for 12 weeks
15730692|NCT05018988|Dietary Supplement|Placebo|1 spray / day for 12 weeks
15730693|NCT05018975|Drug|Tazemetostat|Tazemetostat 800mg BID PO dosing for 15 days
15730694|NCT05018962|Device|Cutting balloon followed by paclitaxel coated balloon|Cutting balloon followed by paclitaxel coated balloon
15730695|NCT05018949|Procedure|Lower limb angioplasty|Patients who have undergone LL angioplasty are enrolled in study for a medical records review.
15730696|NCT05018936|Drug|Hetrombopag|Hetrombopag starting at 5mg/day and increased by 2.5mg/day every 2 weeks if the platelet count remains less than 20×10e9/L and reduced if the platelet count reaches over than 150×10e9/L.
15730697|NCT05018923|Drug|Rabeprazole|20mg bid
15730698|NCT05018923|Drug|Bismuth potassium citrate|0.6g bid
15730699|NCT05018923|Drug|Metronidazole|0.4g qid
15730700|NCT05018923|Drug|Doxycycline|0.1g bid
15730701|NCT05018923|Drug|Tetracycline|0.5g qid
15730702|NCT05018910|Other|Skin to Skin|During routine Skin-to-skin sessions, the heart rate variability of the infant will be measured.
15730703|NCT05018897|Behavioral|To Share or Not to Share|Strategic disclosure intervention to help participants evaluate the pros and cons of disclosing suicidality and provide guidance on best way to disclose to get needs met. Six one-hour virtual sessions conducted weekly.
15730704|NCT05018897|Behavioral|Peer Support|Peer-led support group for mood disorders. Six one-hour virtual sessions conducted weekly.
15730705|NCT05018884|Procedure|Observation of surgical site infections|No intervention is done, only observation of routine clinical practice
15730706|NCT05018871|Biological|autologous adipose derived mesenchymal stem cells|cultured autologous adult adipose derived mesenchymal stem cells
15730707|NCT05018858|Biological|AlloRx|cultured allogeneic adult umbilical cord derived mesenchymal stem cells
15730708|NCT05018845|Biological|AlloRx|cultured allogeneic adult umbilical cord derived mesenchymal stem cells
15730709|NCT05018832|Biological|AlloRx|cultured allogeneic adult umbilical cord derived mesenchymal stem cells
15730710|NCT05018819|Biological|AlloRx|cultured allogeneic adult umbilical cord derived mesenchymal stem cells
15730711|NCT05018806|Drug|Placebo|Pharmaceutical form: Tablet Route of administration: Oral
15730712|NCT05018806|Drug|Rilzabrutinib|Pharmaceutical form: Tablet Route of administration: Oral
15730713|NCT05018793|Biological|autologous adipose derived mesenchymal stem cells|cultured autologous adult adipose derived mesenchymal stem cells
15730714|NCT05018780|Other|Muscle Energy Technique|"Post isometric relaxation: Patient will be asked to perform isometrics on piriformis, iliopsoas and erector spinae muscles one by one. Each isometric contraction will be held for 10 seconds. After 10 seconds, contraction will be released with an exhalation. These contractions will be repeated for 5 times in one session.
~Routine physical therapy including TENS, Hot pack and strengthening exercises will also be delivered along with Muscle Energy Technique."
15730715|NCT05018780|Other|Sacral Manipulation|"To manipulate an iliac anterior rotation displacement sacroiliac joint dysfunction and to restore posterior rotation of the ilium, participant will be positioned in side lying. Therapist will place one hand at Anterior superior iliac supine (ASIS) and the other at Ischial tuberosity. A quick thrust will be applied and ASIS will be pushed posteriorly while Ischial tberosity anteriorly. This will be maintained for 10 to 30 seconds.
~To manipulate an iliac posterior rotation displacement sacroiliac joint dysfunction and to restore anterior rotation of the ilium, participant will be in prone position. One hand of therapist will be at Posterior superior iliac supine (PSIS) and the other one at pubic rami. A quick thrust will be delivered and PSIS will be moved anteriorly while pubic rami posteriorly. This will be maintained for 10 to 30 seconds.
~Routine physical therapy including TENS, Hot pack and strengthening exercises will also be delivered along with Sacral Manipulation."
15730716|NCT05018767|Biological|AlloRx|cultured allogeneic adult umbilical cord derived mesenchymal stem cells
15730717|NCT05018754|Device|TREATMENT OF ORAL MUCOSITIS USING PLATELET-RICH-FIBRIN (PRF)|All patients were affected by oral mucositis (9 RIOM, 6 chemotherapy-related oral mucositis). They were treated with almost 2 different systemic therapies before and during platelets gel applications. Median of time before the lesions were treated with platelets gel were 7 days. Lesions affected buccal mucosa, tongue, labial commissure and lower lip. Preliminar parameters were the microbiological contamination of lesions and presence of pain. Patients refer spontaneous widespread pain worsened by swallowing and feeding. Response to treatment has been evaluated in relation to the reduction of lesions dimensions, to the involution of pain and presence of granulation tissue after every application of platelet gel.
15730718|NCT05018741|Procedure|liver transplantation|liver transplantation for chronic liver disease or acute liver failure
15730719|NCT05018728|Drug|Voxelotor|Voxelotor is taken orally once a day. Participants 12 years or older will take 1500 mg/day. Participants younger than 12 years of age will receive a dose based on their body weight to provide exposure corresponding to the adult dose of 1500 mg/day.
15730720|NCT05018715|Diagnostic Test|Machine learning model diagnosis|Machine learning model diagnosis
15730721|NCT05018702|Drug|ARX788|1.5 mg/kg IV infusion on Day 1 of each 21-day treatment cycle.
15730722|NCT05018689|Other|Aevidum curriculum|The Aevidum curriculum will be delivered to 9th grade students at participating high schools in both study arms. All school staff who plan to deliver the curriculum will participate in a web-based training workshop with the Aevidum Executive Director.
15730723|NCT05018689|Other|Club|Schools will identify ten students interested in participating in an Aevidum club. Following training of interested students, schools are asked to commit to running two Aevidum club activities during the school year.
15730724|NCT05018676|Drug|ARX788|1.5 mgkg IV infusion on Day 1 of each 21-day treatment cycle.
15730725|NCT05018663|Other|Artificial Intelligence software ROSE|Rapid on-site evaluation (ROSE) of Endoscopic Ultrasound (EUS) guided FNA/FNB (Fine Needle Aspirate/Fine Needle Biopsy) of pancreatic solid lesions (PSLs) has been shown in improve diagnostic yield. The availability and performance of ROSE at EUS performing centers is variable. With strides in Artificial Intelligence (AI) capabilities over the years, the University of Texas at Health Sciences Center at Houston in collaboration with Haystac is developing an artificial intelligence based proprietary system to analyze slides from EUS FNA/FNB samples at bedside.
15730726|NCT05018637|Drug|WJ-MSC|"Other: subcutaneous injection of 20 µg teriparatide once daily for 6 months, followed by oral administration of anti-resorptive drug for 6 months.
~Other: intramedullary injection of 4 x 107 WJ-MSCs (direct injection into the recently fractured vertebra) at baseline (day 0). subcutaneous injection of 20 µg teriparatide once daily for 6 months, followed by oral administration of anti-resorptive drug for 6 months."
15730727|NCT05018637|Drug|Teriparatide|subcutaneous injection of 20 µg teriparatide once daily for 6 months, followed by oral administration of anti-resorptive drug for 6 months.
15730728|NCT05018624|Behavioral|Alcohol brief intervention|At baseline, subjects will receive face-to-face or online alcohol brief intervention developed based on the guideline by the World Health Organisation in 5-10 minutes
15730729|NCT05018624|Behavioral|12-page health warning leaflet|Nurses will provide information about the consequences of drinking using a 12-page health warning booklet. Benefits of reducing and quit drinking will be emphasized by focusing on improving their perception towards the impacts on health, social problems, risky behaviors, academic performance and financial issues.
15730730|NCT05018624|Behavioral|Regular messages through Instant Messaging (IM)|A total of 26 e-messages will be scheduled: once daily for the first week, 3 time/week for subsequent 4 weeks and 1 time/week for the remaining 7 weeks. The frequency will be adjusted according to IM Apps conversation and subject's requests.
15730731|NCT05018624|Behavioral|Real-time chat-based support through IM Apps|The chat-based IM support is the extension of baseline ABI and regular e-messages, which aims to provide real-time behavioral and psychosocial support to reduce or quit drinking. It will be personalized according to the subjects' characteristics (gender, drinking pattern and alcoholic drinks preferences), intention to drink and specific questions regarding drinking. Through real-time chatting (text and/or voice), drinkers can acquire information on consequences of drinking and gain social support immediately to reduce intention to drink and alcohol consumption.
15730732|NCT05018624|Behavioral|General health through IM Apps|After baseline, they will receive regular e-message through IM Apps with similar frequency to Intervention group with content on general health and the reminding the importance of participating in the follow-up surveys.
15730733|NCT05018624|Behavioral|AUDIT score interpretation sheet adapted from the Department of Health of Hong Kong|"a diagram explaining drinking behaviour and potential health risks, definitions of alcohol unit and binge drinking, and advise on limiting daily drinking to 2 alcohol units for men and 1 unit for women"
15730734|NCT05018611|Behavioral|LifeSkills Mobile|A mobile app designed to facilitate the broad reach and impact of the LifeSkills intervention to reduce sexual risk behavior which drives HIV infection. The LifeSkills intervention addresses the specific structural, developmental, and interpersonal challenges to HIV prevention among YTW ages 16-29, with prior evidence of the efficacy to reduce sexual risk.
15730735|NCT05018598|Drug|Administration via pressurized metered dose inhaler (pMDI)|Either CHF5993 or CHF1535
15730736|NCT05018585|Biological|Recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel®|Recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel®
15730737|NCT05018585|Dietary Supplement|Colecalciferol 2000 IU|Colecalciferol (vitamin D3) 2000 IU (equivalent to 50 microgram vitamin D3).
15730738|NCT05018585|Biological|Placebo for recombinant human glutamic acid decarboxylase (rhGAD65) formulated in Alhydrogel®|Placebo for Diamyd, Alhydrogel® only
15730766|NCT05018325|Procedure|Colonoscopy with 6 minute withdrawal|Withdrawal time will be determined using a digital stopwatch by the nursing staff.
15730767|NCT05018325|Procedure|Colonoscopy 9 minute withdrawal|Withdrawal time will be determined using a digital stopwatch by the nursing staff.
15730768|NCT05018325|Procedure|Colonoscopy 12 minute withdrawal|Withdrawal time will be determined using a digital stopwatch by the nursing staff.
15730769|NCT05018312|Behavioral|Modified Collaborative Assessment (MCA)|The Modified Collaborative Assessment (MCA) will be assessment of the patients that Is more thoroughly-done, and which will be inspired by the school of Therapeutic Assessment and Collaborative Assessment. It will include the EASE, SCID-interview, PSE, ADOS and SCIP-interviews.
15730739|NCT05018572|Behavioral|I AM|"I am has a biopsychosocial perspective with a focus on pain management in migraines. The cognitive behavioural interventions being tested are Mindfulness, Acceptance and Commitment Therapy (ACT), Compassion Focused Therapy and Physiotherapist-led cardiotherapy. The treatment program consists of ten modules of texts, animated films with a fictional person to identify with, recorded audio exercises adapted for patients with migraines and filmed physiotherapeutic exercises with physiotherapists.The interventions in I am are personalised in that the first three modules and module 10 are for those who are being helped by a shorter treatment. The other modules, four to ten, are a more in-depth treatment for those who have frequent or chronic migraines. The participants are in contact with processors via message function as well as via phone at startup, at the middle of treatment and termination. The duration of treatment is 4-10 weeks."
15730740|NCT05018559|Behavioral|BuG lesson|Participants of the intervention group in nursing care received a co-created setting-specific intervention to promote physical activity called BuG lesson. The BuG lesson comprises a weekly 90-minute lesson for apprentices of nursing care during regular school hours, covering physical activity and health in theory and practice. Previously, the nursing teachers voluntarily underwent a qualification process as physical activity instructors, enabling them to conduct the BuG lessons independently.
15730741|NCT05018559|Behavioral|Tutoring system|Participants of the intervention group in automotive mechatronics received a co-created setting-specific intervention to promote physical activity called tutoring system. In the tutoring system, automotive mechatronics apprentices act as physical activity promotors for their fellow apprentices. In the sense of a peer-to-peer approach, apprentices voluntarily participate in a workshop to be qualified as tutors. Subsequently, the tutoring system takes place every two weeks for about ten to fifteen minutes during regular working hours, allowing the tutors to discuss the issues of physical activity and health among their peers.
15730742|NCT05018546|Procedure|Irrigation force|RIRS with different irrigation force
15730743|NCT05018533|Drug|TAKC-02|Inhalation Solution
15730744|NCT05018533|Drug|Placebo|Inhalation Solution
15730745|NCT05018520|Drug|Six Courses of R-CHOP Plus Two Courses of Rituximab|The patients will be given RCHOP (Rituximab 375mg/m2 ivgtt, D0, Cyclophosphamide 750mg/m2, ivgtt D1, doxorubicin 50mg/m2,ivgtt D1, Vincristine 1.4mg/m2（max 2mg）, ivgtt D1 Prednisone 60mg/m2 （max 100mg）,PO,D1-D5 every 21 days for total 6 courses) followed by Rituximab (375mg/m2 d1, every 21 days for total 2 courses)
15730746|NCT05018520|Drug|Four Courses of R-CHOP Plus Four Courses of Rituximab|The patients will be given RCHOP (Rituximab 375mg/m2 ivgtt, D0, Cyclophosphamide 750mg/m2, ivgtt D1, doxorubicin 50mg/m2,ivgtt D1, Vincristine 1.4mg/m2（max 2mg）, ivgtt D1 Prednisone 60mg/m2 （max 100mg）,PO,D1-D5 every 21 days for total 4 courses) followed by Rituximab (375mg/m2 d1, every 21 days for total 4 courses)
15730747|NCT05018507|Other|Data collection only|No intervention, just data collection from system machines
15730748|NCT05018494|Other|experimental treatment|This group will receive the common treatment and will be discharged with complete manual on life style modifications comprising education, exercise and diet with telerehabilitation monitoring.
15730749|NCT05018494|Other|common treatment|This group will receive the common treatment and will be discharged with home exercise plan without telerehabilitation monitoring.
15730750|NCT05018481|Drug|Sodium Hyaluronate|Sodium hyaluronate of molecular weight 35kDa will be given in capsule form to study participants
15730751|NCT05018481|Drug|Placebo|A placebo will be given in capsule form to study participants
15730752|NCT05018468|Device|Ventilation|Patients in group 1 undergo ventilation with an anatomical facial mask and 100% oxygen for three minutes. Patients in group 2 undergo ventilation with a nasal mask and 100% oxygen for three minutes. In both groups, ventilation will be performed with the controlled mode of the anesthesia machine with a volume of 8 cc/kg and a speed of 12-20/min.
15730753|NCT05018455|Other|Fall prevention program training based on Otago principles|balance and strength exercises
15730754|NCT05018429|Procedure|nerve sparing|When resect the bladder and prostate, the neurovascular bundles around the prostate will be preserved.
15730755|NCT05018416|Drug|Renal Autologous Cell Therapy (REACT)|Renal Autologous Cell Therapy consists of autologous selected renal cells (SRC) obtained from an individual subject's renal biopsy and expanded in vitro and prepared for intra-renal injection. To manufacture REACT, biopsy tissue from each enrolled subject will be sent to ProKidney, in whose Good Manufacturing Practices (GMP) facilities, renal cells will be expanded and SRC isolated. Selected renal cells will be frozen at a concentration of 100 × 106 cells/mL and shipped to the clinical site
15730756|NCT05018403|Drug|Intravenous AON-D21|AON-D21 is a Pegylated L-configured aptamer that binds and thereby neutralizes the complement component C5a from activating both C5a receptors.
15730757|NCT05018403|Drug|Intravenous placebo|Isotonic glucose solution identical in appearance to AON-D21.
15730758|NCT05018390|Other|Osteopathic manipulative treatment|Participants will be positioned on an exam table supine, seated, or decubitus. Osteopathic manipulations will consist in corrective micro-movements applied on synovial joints, on the skull, the teeth and/or visceral structures of the abdomen or the thorax. Local pressures won't exceed a few tens of grams/cm². Practitioners will realize between 15 and 25 technical gestures per participant. Treatment will last 30 minutes (plus or minus 5 minutes) on average. The technical gestures are referenced in the Glossary of Osteopathic Terminology published by the American Association of Colleges of Osteopathic Medicine (2017).
15730759|NCT05018390|Other|Sham Osteopathic manipulative treatment|Participants will be positioned on an exam table supine, seated, or decubitus. They will receive 20 gestures that will be standardized and different from actual osteopathic manipulations (but not identifiable as sham manipulations by the participants). The duration of the sham treatment will be the same as the actual treatment.
15730760|NCT05018377|Procedure|Racz adhesolysis|adhesiolysis in failed back surgery
15730761|NCT05018377|Device|NAVI adhesolysis|adhesiolysis in failed back surgery
15730762|NCT05018364|Diagnostic Test|Serum erythropoietin level|Evaluate serum erythropoietin level in neonates exposed to hypoxia compared to control group
15730763|NCT05018351|Behavioral|Integrated Care|Participants receive integrated physical and mental health care from their usual provider.
15730764|NCT05018351|Behavioral|Peer Navigation|Peer navigators will meet individually and face-to-face with participants to address their health and weight goals (i.e. working on health-related goals, attending health care appointments. and facilitating follow-up activities related to healthcare appointments).
15730876|NCT05017480|Drug|CBP-201|CBP-201 subcutaneous(SC) injection.
15730770|NCT05018312|Behavioral|Assessment as Usual (AAU)|Assessment as usual is the standard assessment the patients will receive in the clinic. It includes one or more interviews with a mental health professional in the clinic.
15730771|NCT05018299|Biological|FB704A placebo|lacebo
15730772|NCT05018299|Biological|FB704A|Anti-IL-6 antibody
15730773|NCT05018286|Drug|Apraglutide|Apraglutide is a synthetic peptide analogue of GLP-2 under development for treatment of SBS-IF, which acts as a full agonist at the GLP-2 receptor with in vitro potency and selectivity comparable with native GLP-2
15730774|NCT05018273|Biological|VB10.NEO|The personalized vaccine VB10.NEO vaccine is given in combination with the PD-L1 inhibitor atezolizumab.
15730775|NCT05018260|Behavioral|Attention Bias Modification|Feedback according to participants' viewing patterns, in order to modify their attention bias to threat
15730776|NCT05018260|Behavioral|Attention Control|Feedback according to participants' viewing patterns, in order to strengthen their attention control
15730777|NCT05018247|Procedure|Revascularization by Coronary Artery Bypass Graft or Percutaneous Coronary Intervention|Urgent revascularization via CABG or PCI combined with Optimal Medical Treatment
15730778|NCT05018234|Device|Noval Oral Appliance|A scan of the mouth will be performed to make the oral device. The device will be 3D printed with Asiga UV Max printer using FDA 510(k) cleared VeriSplint OS Resin.Subjects will be will be asked to wear the oral device at night for 3 nights and fill out a survey reviewing their experience wearing the device.
15730787|NCT05018208|Other|Computer-Assisted Intervention|Use smartphone app
15730788|NCT05018208|Procedure|Patient Monitoring|Wear Biofourmis wearable device(s)
15730789|NCT05018208|Other|Questionnaire Administration|Complete questionnaires
15730790|NCT05018195|Procedure|Excise adipose tissue|Perform partial omentectomy to obtain one 5*5 cm omental fat and excise one 3*3 cm subcutaneous adipose tissue( 2 finger width above the pubic symphysis) during surgery
15730791|NCT05018182|Drug|Oxaliplatin|Oxaliplatin 85 mg/m² Q2w(2 h) before surgery rection and 130 mg/m² Q3w (2 h) after surgery
15730792|NCT05018182|Drug|Irinotecan|Irinotecan 150 mg/m² ivgtt(1.5 h) Q2w before surgery rection
15730793|NCT05018182|Drug|Folinic Acid|Folinic acid 400 mg/m² ivgtt(2 h) Q2w before surgery rection
15730794|NCT05018182|Drug|5FU|5-FU 2800 mg/m² civ(46 h) Q2w before surgery rection
15730795|NCT05018182|Drug|Capecitabine|Capecitabine 1000mg/m² d1-14 po Q3w after surgery rection
15730796|NCT05018169|Behavioral|BA-A|Session 1 focuses on the treatment rationale, structure, and expectations, and includes psychoeducation on depression. Session 2 focuses on working with parent(s) to help them support their teen through treatment. Session 3 focuses on the (situation)/behavior/feeling cycle and how teens individuals can get trapped in a cycle of depression and inactivity. Session 4 focuses on the assessment of values and choosing preferred activities to target. Session 5 focuses on teaching skills for in-person and electronic communication. Session 6 focuses on identifying barriers to treatment success. Session 7 focuses on teaching teens to handle disagreements. Session 8 focuses on the utilization of adaptive coping skills. Sessions 9-11 are meant to be used flexibly and should include review of any challenging concepts. Session 12 is the termination session and focuses on maintaining treatment gains. Between every session, teens will track their activity for homework.
15730797|NCT05018156|Behavioral|Default Genetics Referral Process|Patients and their oncology providers will be notified of their eligibility for a cancer genetics referral, with an option to opt out if they are not interested in proceeding. Everyone else will be automatically referred to their local hospital's cancer genetics program for contact and scheduling. Standard genetic counseling, testing, and results disclosure will take place, including usual methods of payment and insurance coverage for testing.
15730798|NCT05018143|Behavioral|STARS|This intervention will use an online mobile application for teach life skills, coupled with peer mentoring to support the use of safety planning.
15730799|NCT05018143|Behavioral|Control condition|In this intervention, participants will receive the safety planning intervention.
15730800|NCT05018130|Procedure|Calcaneus Osteotomy (Metallic)|Calcaneus Displacement Osteotomy using two metallic screws
15730801|NCT05018130|Procedure|Calcaneus Osteotomy (Bio-integrative)|Calcaneus Displacement Osteotomy using two bio-integrative screws
15730802|NCT05018117|Drug|Nicotine gum|The effects of over-the-counter nicotine gum will be compared to a placebo gum
15730803|NCT05018117|Other|Placebo gum|The effects of over-the-counter nicotine gum will be compared to a placebo gum
15730804|NCT05018104|Other|This is not an interventional study|This study utilizes data from the St. Paul's Hospital Peripheral Nerve Block Database.
15730808|NCT05018078|Biological|Coronavirus vaccine|Coronavirus vaccine was inoculated on day 0 and day 25±3, respectively
15730809|NCT05018065|Behavioral|Women sexual dysfunctions were screened using Female Sexual Functioning Index (FSFI)|sexual dysfunction assesment
15730810|NCT05018039|Other|Collaborarive Care Model|"Collaborative care involves three professionals: a physical health care provider (physiotherapist or occupational therapist), a mental health care provider and a case manager. The case manager will work closely with the patient to identify the mental health support necessary. This may involve appointments with a psychologist or psychiatrist as part of their musculoskeletal treatment.
~The case manager will define a treatment plan and organise appointments with the patients and monitor their progress using validated questionnaires, adjusting their mental or physical care support when required. This professional will also monitor patients' attendance and support managing their appointments and routinely update the clinical team on patient progress, and relaying information back to the clinical team. This model of care will work in parallel to the regular musculoskeletal appointments (usual care)."
15730811|NCT05018026|Behavioral|Nutri-Grade labels|All beverage products in the arm are displayed with the Nutri-Grade label. This label was proposed by the Ministry of Health in Singapore to be implemented at the end of 2021. It will apply to all pre-packaged non-alcoholic beverages sold in Singapore. It will have four color-coded grades wherein Grade A, corresponding to the lowest sugar and saturated fat thresholds, will be in green and Grade D, corresponding to the highest sugar and saturated fat thresholds, will be in red.
15730812|NCT05018013|Drug|Ammoxetine hydrochloride enteric-coated tablets|Ammoxetine hydrochloride enteric-coated tablets
15730813|NCT05018013|Drug|Duloxetine hydrochloride enteric-coated capsules|Duloxetine hydrochloride enteric-coated capsules
15730814|NCT05018013|Drug|Placebo to Ammoxetine|Placebo to Ammoxetine
15730815|NCT05018013|Drug|Placebo to Duloxetine|Placebo to Duloxetine
15730816|NCT05018000|Behavioral|Financial navigation|The CAFÉ intervention is a financial navigation intervention. During the Intervention, a CAFÉ financial navigator will provide information support and resources to people with cancer after diagnosis. CAFÉ intervention components include: (1) proactive assessment of patient financial questions and concerns (e.g., acute financial need or inability to pay for household expenses; deciding between care options depending on cost; uncertainty around planning for out of pocket costs and/or when patients will need to pay), (2) proactive, personalized support and referrals.
15730817|NCT05018000|Behavioral|Enhanced usual care|The financial resource sheet lists and describes existing internal and community resources available to KP members
15730818|NCT05017987|Drug|ATB-101, ATB-1011, ATB-1012|"Test drug
~- Code name: ATB-101
~Control drug1
~Code name: ATB-1011
~Active ingredient: Olmesartan
~Control drug2
~Code name: ATB-1012
~Active ingredient: Dapagliflozin"
15730819|NCT05017974|Behavioral|Mindfulness-Based Stress Reduction plus Prenatal Sleep supplement|MBSR+PS
15730820|NCT05017974|Other|Treatment as Usual|TAU
15730821|NCT05017961|Device|Autograft|An autograft bone will be harvested from proximal tibia or posterior superior iliac crest. First the bony landmarks of the posterior iliac crest or proximal tibia are palpated. The skin is then injected down to and including the periosteum with 1% lidocaine without epinephrine. After 1 cm skin incision and gentle dissection of subcutaneous soft tissue, the bone harvesting device inserted through the skin and subcutaneous tissues until it reaches the cortical bone. Then, manual pressure is used to position the bone harvesting device against the dense cortical bone. A battery-powered power instrument is then will be used to drill the harvesting device into the medullary cavity. After the harvesting device insertion the cancellous strips of bone will be harvested and applied to the fracture site gap.At the conclusion of autograft bone harvesting procedure, the wound will be closed with 3-0 Nylon and a sterile dressing will be applied to the harvest site.
15730822|NCT05017961|Device|Allograft only|The jar containing allograft tissue and cryopreservation solution will be placed in a sterile basin containing a warm (35°C to 39°C; 95°F to 102.2°F) sterile irrigant (Normal saline or 5% Dextrose in Lactated Ringer's Solution). The jar containing the allograft will remain in this solution until the contents of the jar flows freely upon inversion. The jar will be removed from the warm solution once free-flowing. Sterile gauze or the optional strainer will be used to decant the cryopreservation solution into a waste container. 5% Dextrose in Lactated Ringer's Solution will be added to the indicated fill line to immerse the allograft tissue. The cap will be replaced and inverted twice to suspend tissue until ready for use. 5% Dextrose will be decanted in Lactated Ringer's Solution prior to use. Implant will be used within 2 hours of thawing.
15730823|NCT05017961|Device|Allograft combined with BMAC|A bone marrow aspiration kit will be used for bone marrow aspiration. First the bony landmarks of the posterior iliac crest and sacroiliac joint are palpated. The skin is then injected down to and including the periosteum with 1% lidocaine without epinephrine. Then, the bone marrow aspiration trochar and needle are percutaneously inserted through the skin and subcutaneous tis- sues until it reaches the posterior iliac crest. The trajectory of the needle will be parallel to the iliac crest, or perpendicular to the Anterior Superior Iliac Spine (ASIS) or Posterior Superior Iliac Spine (PSIS), depending on the harvest site used. After the trochar is inserted into the posterior iliac crest but prior to aspiration, 1 mL of heparin (1,000 U/mL) will be preloaded into the syringe. Approximately 60 mL of bone marrow will be aspirated, which requires the use of two 30-mL syringes. At the conclusion of BMAC harvesting, a sterile dressing will be applied to the harvest site.
15730825|NCT05017935|Device|Renal Denervation|Renal angiogram and renal denervation (Paradise Renal Denervation System)
15730827|NCT05017909|Behavioral|Face to face education|Face to face education techniques on the acquisition of the mothering Role
15730828|NCT05017909|Behavioral|Web based education|web based education techniques on the acquisition of the mothering Role
15730829|NCT05017909|Behavioral|No education|Control group will not be educated
15730830|NCT05017896|Diagnostic Test|Normal CT Renal Perfusion imaging indexes|A CT imaging which indicates the status of renal perfusion is normal.
15730831|NCT05017896|Diagnostic Test|Low CT Renal Perfusion imaging indexes|A CT imaging which indicates the status of renal perfusion is low.
15730832|NCT05017883|Drug|TAA05 cell injection|"Chimeric antigen receptor T cells (car-t)
~Chimeric antigen receptor T cells (car-t) is one of the most effective therapies for malignant tumors (especially hematological tumors). Like other immunotherapies, the basic principle is to use the patient's own immune cells to clear cancer cells. Chimeric antigen receptor (car) is the core component of car-t, which endows T cells with the ability to recognize tumor antigens in an independent manner,which enables car modified T cells to recognize a wider range of targets than natural T cell surface receptors (TCR). The basic design of car includes a tumor associated antigen binding region (usually derived from scFv segment of monoclonal antibody antigen binding region), transmembrane region and intracellular signal region. The selection of target antigen is a key determinant for the specificity and effectiveness of car and the safety of genetically modified T cells."
15730833|NCT05017870|Drug|KSR-001|(0 day) eye drops received one drop to both eyes once a day (1~5 day) eyedrops recieved one drop to both eyes four times a day
15730834|NCT05017870|Drug|KSR-004|(0 day) eye drops received one drop to both eyes once a day (1~5 day) eyedrops recieved one drop to both eyes four times a day
15730835|NCT05017870|Drug|KSR-001-02|KSR-001-02
15730836|NCT05017870|Drug|KSR-001-03|KSR-001-03
15730839|NCT05017844|Drug|KSR-001-04|One drop to both eyes four times a day for 12 weeks
15730840|NCT05017844|Drug|KSR-001-02|One drop to both eyes four times a day for 12 weeks
15730841|NCT05017844|Drug|KSR-001-03|One drop to both eyes four times a day for 12 weeks
15730842|NCT05017831|Behavioral|Family Based Treatment|Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
15730843|NCT05017831|Behavioral|Cognitive Remediation Therapy|Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition. CRT is a behavioral treatment that presents tasks to participants in a standardized order within each session. Each task has a number of levels. Participants stay at the same task-based level until mastered. They then move up a level on that task. participants can be at different levels on different tasks within each session. After completion of tasks, participants are asked to reflect on their thought processes in solving the tasks. Standard prompts are used to guide the discussion.
15730844|NCT05017818|Other|Retrospective Study|This is a retrospective medical cart review. We are not treating any patients.
15730845|NCT05017805|Biological|COVID-19 Vaccines|One dose (0.5 mL) of coronavirus vaccine was inoculated on day 0 and day 25±3, respectively.
15730846|NCT05017792|Biological|Astrazenica vaccine|COVID-19 vaccines should be administered by intramuscular (IM) injection, preferably into the deltoid muscle of the upper arm. Individuals who have minimal muscle mass in the deltoid area of the upper arm, or a particular reason to avoid immunization in the deltoid muscle, can be given their vaccine in the vastuslateralis muscle in the thigh if necessary.
15730849|NCT05017766|Other|analysis of antimicrobial resistance|"In samples from patients infected with one of the focus pathogens (E. coli, Klebsiella species, S. aureus, P. aeruginosa) will be:
~(i) isolated and pathogenic bacteria characterized; (ii) pathogen in-situ properties at single-cell and bulk average determined; (iii) human metabolites, proteins and cells determined (iv) antibiotic concentration determined (v) bacterial growth monitored
~Deducted from the data will be:
~relevant human components and pathogen properties that are common to most patients with similar indication
~underlying regulatory networks and triggers in pathogen cells and human tissues.
~Clinical outcomes (survival/mortality) and treatment response (response or failure) will be correlated to the in vitro retrieved host and bacterial data."
15730850|NCT05017753|Procedure|Thoracentesis|Thoracentesis will be performed according to local practice, either at the ward or at the radiology department, in addition to standard-of-care medical treatment.
15730851|NCT05017753|Drug|Standard-of-care medical treatment|Standard-of-care medical treatment
15730852|NCT05017740|Procedure|ICSI or PICSI|In ICSI, the sperm is chosen based on motility and gross morphology to be inseminated directly into the cytoplasm of the oocyte; where as in PICSI, the sperm is selected via hyaluronic binding before insemination as per ICSI procedure.
15730877|NCT05017480|Drug|Placebo|subcutaneous(SC) injection
15731052|NCT05016154|Behavioral|Mood Flow|Group of participants make use of the Mood Flow app
15735787|NCT04978584|Drug|Vincristine|Given IV
15730853|NCT05017727|Device|Closed-loop automated oxygen control with Oxygenie Auto-O2 software (SLE6000)|The 'Oxygenie' is a closed loop automated oxygen control system that has been incorporated into a software module for the SLE6000 infant ventilators. This software control system allows targeting SpO2 values by controlling FiO2.
15730854|NCT05017714|Drug|Recombinant cytokine gene derived protein injection|"Aerosolized Novaferon, given 20 ug BID, daily for 7 days, plus Standard of Care.
~Inhaled Saline (placebo), given BID, daily for 7 days, plus Standard of Care."
15730855|NCT05017688|Procedure|Blood and stool sample collection|Collection of blood samples (10 mL) Collection of fecal samples (10g)
15730856|NCT05017675|Other|High fructose diet|"4 week high fructose diet.
~Intended composition (En%):
~Carbohydrates: 60-70 Fat: 20-30 Protein: 10-15 Fructose: 20 SFA: 5"
15730857|NCT05017675|Other|High saturated fat diet|"4 week high saturated fat diet.
~Intended composition (En%):
~Carbohydrates: 35-45 Fat: 40-50 Protein: 10-15 Fructose: 5 SFA: 20"
15730859|NCT05017649|Biological|Blood sample|Blood sampling.
15730860|NCT05017636|Device|shock wave therapy|The participants received the treatment protocol established by the manufacturer of the Thork Shock Wave® device, IBRAMED- Industria Brasileira de Equipamentos Electromédicos, Amparo, São Paulo approved by Anvisa No. 10360310036. (Figure 1). The parameters were, 4,000 thousand shots with energy of 180mJ and frequency of 15Hz with 15mm stainless steel tip and 2,000 shots with energy of 100mJ and frequency of 15Hz with 15mm plastic tip, and for the tip slip, Neutral Thork® Lotion, RMC was used. Seven ESWT sessions were held, the average time of each was seven minutes, twice a week and the seventh session was held minutes before the surgical procedure of bariatric surgery, therapy was performed in an area of 150cm² on the left side of the abdominal region following the midline. The right side of the participants' abdomen did not receive ESWT and was termed as control.
15730861|NCT05017623|Drug|YH003|All subject will receive YH003 intravenously as single agent every three weeks (Q3W) for up to 1 years, until intolerable toxicity, confirmed disease progression, withdrawal of consent, or Investigator decision, whichever comes first.
15730862|NCT05017610|Drug|Liothyronine|Given PO
15730863|NCT05017610|Drug|Lomustine|Given PO
15730864|NCT05017610|Drug|Methimazole|Given PO
15730865|NCT05017597|Other|Rehabilitation|Exercises completed, and rate of perceived exertion (RPE) will be reviewed during & after each exercise session. Exercises will be modified by either increasing or decreasing the intensity. Decisions will be made based RPE, physical symptoms & any identified barriers or supports. Weeks 1, 3, 5, & 7, Cancer-related fatigue (CRF) education will be assigned. During weeks 2, 4, 6, & 8, CRF education will be reviewed and a plan for how to apply the information will be developed. Participant will be guided through 6 steps of problem solving to address one occupational performance problem identified by participant within Canadian Occupational Performance Measure. Goal & action plan for the week will be shared with the participant electronically. At the beginning of each session, participant will describe progress on previous week action plan. Based on participant's response, either a new goal will be developed or the current one modified..
15730866|NCT05017584|Drug|Hyperbaric bupivacaine|"The dose for the first subject (A#X) will be 12 mg 0.75% hyperbaric bupivacaine. Two possible outcomes will be recorded: satisfactory or unsatisfactory anesthesia which is determined by occurrence of intraoperative pain and the need for intraoperative analgesia supplementation. Satisfactory analgesia will be defined as a sensory block to the T8 dermatome and the patient shall require no further supplementation for discomfort during her procedure. Unsatisfactory analgesia will be defined as a block not achieving a T8 dermatomal level or when a patient requests additional medication for discomfort at any time during her procedure.
~The dose for the next (A#X+1) will be adjusted based on the outcome from previous subjects respectively using up-down sequential allocation method with a biased-coin design. This process will continue in similar fashion with dose adjustments for next subjects to be based on outcome from subjects immediately prior."
15730869|NCT05017558|Diagnostic Test|point of care|"HIV-1 infected women will benefit from a viral load measurement by POC (Cepheid GenXpert HIV-1 viral load) at the time of delivery.
~Newborns will benefit :
~Antiretroviral preventive treatment differentiated according to their risk of infection in accordance with national recommendations:
~High risk (maternal VL ≥1000 cp/ml): AZT/NVP for 12 weeks.
~Low risk (maternal VL <1000 cp/ml): NVP for 6 weeks.
~virological screening for HIV by qualitative POC (Cepheid GenXpert HIV-1 qual) from birth (for high-risk newborns) at 6 weeks, at 9 months and at any time in the event of clinical manifestations suggestive of HIV infection.
~In the event of a positive HIV test, the child will initiate immediately AZT/3TC/LPV/r
~support from volunteers to improve retention in care, promotion of exclusive breastfeeding and family nutritional support"
15730873|NCT05017532|Behavioral|The program Remédiation Cognitive de la Cognition Sociale en Schizophrénie (RC2S+)|The program Remédiation Cognitive de la Cognition Sociale en Schizophrénie (RC2S+) is a personalized CR treatment targeting social cognition (e.g. theory of mind, emotion recognition) using virtual reality to emulate daily social interactions
15730874|NCT05017506|Other|A survey will be made.|A survey will be made.
15730875|NCT05017493|Combination Product|Xagrotin|A group of patients were treated with Xagrotin with or without standard of care, the control group received stadard of care
15730878|NCT05017467|Drug|undefinedCentella Asiatica Extract|"All patients were asked about scar hypertrophy, scar tenderness, and pillar pain.
~The scar assessment was performed using the Vancouver Scar Scale (VSS) at the one, three and 6 months after surgery.
~Patients were asked to complete pre- and postoperative functional evaluations. The VAS score and QuickDASH test was used"
15730879|NCT05017454|Drug|the optimized sodium valproate-loaded nanospanlastic dispersion|participants will apply the optimized sodium valproate-loaded nanospanlastic dispersion twice daily, on the affected areas of the scalp for 3 months
15730880|NCT05017454|Drug|mometasone furoate lotion|participants will apply marketed mometasone furoate lotion twice daily on the affected areas of the scalp for 3 months
15730881|NCT05017428|Dietary Supplement|Spermidine|Spermidine in the form of a 0.1% spermidine wheat germ extract
15730882|NCT05017428|Dietary Supplement|Nicotinamide|Nicotinamide given as niacinamide
15730883|NCT05017428|Dietary Supplement|PEA|Palmitoylethanolamide given at 98% purity
15730884|NCT05017428|Dietary Supplement|OEA|Oleoylehtanolamide given at 90% purity
15730885|NCT05017428|Dietary Supplement|Wheat Flour|Wheat flour given as a placebo control
15730888|NCT05017402|Drug|Alglucosidase Alfa|Standard dose: 20-25 mg/kg every other week; Higher dose: >25 mg/kg every other week.
15730889|NCT05017389|Diagnostic Test|Griffiths development scales|Griffiths development scales Chinese Edition (gds-c) was used to evaluate the development levels of children up to 6 years and WISC for children more than 6 years.
15730890|NCT05017376|Procedure|small incision lenticular extraction|In patients with the same degree of myopia, different optical zones were designed for operation
15730891|NCT05017363|Procedure|ENGAGE|Goal-setting approach and strategies including the Perceived Efficacy and Goal Setting Tool (PEGS) and the Pediatric Activity Card Sort (PACS), which are established goal setting tools for children aged 5-9 and 5-14, respectively. Goal Attainment Scaling and administration of the Canadian Occupational Performance Measure (COPM), the most widely used goal setting tool in paediatric rehabilitation that has been used with children as young as seven years. Introducing simple strategies to assist children in identifying goals and to ensure ongoing focus on goals using principles of motivational interviewing, strategies to assess and nurture perceived competence (self-efficacy), and child-friendly feedback strategies on goal-related performance.
15730892|NCT05017350|Procedure|radiofrequency ablation|Under the ultrasound guidance, the electrode is inserted into the bleeding focus of the liver and the bleeding focus is ablated.
15730893|NCT05017324|Device|WGS DST strategy|WGS DST strategy for diagnosing the TB drug resistance profile and an algorithm-determined individualised RR-TB treatment recommendation
15730894|NCT05017311|Drug|Escitalopram|All patients will receive open-label escitalopram (10-20 mg/d) for the entire study duration (12 weeks).
15730895|NCT05017311|Drug|Brexpiprazole|Depending on the initial randomization process, patients will either receive blinded brexpiprazole (0.5-2 mg/d) for the entire study duration (12 weeks) or for the last 4 weeks of the study if they received the placebo during the first 8 weeks of the study and were non-responders.
15730896|NCT05017298|Biological|Autologous adipose-derived stem cells|Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue
15730897|NCT05017285|Procedure|HoLEP with median lobe preservation|Enucleation of the lateral lobes and preservation of the medial tissue between the bladder neck and Veru montanum
15730898|NCT05017285|Procedure|HoLEP classic|Standard HoLEP prostate resection procedure with enucleation of all three lobes (3-lobe, 2-lobe or monobloc technique).
15730899|NCT05017272|Other|Opioid Addiction Recovery Support Software Platform|OARS (Opioid Addiction Recovery Support) is used by providers of MAT programs to improve insight into a patient's recovery progress while promoting ownership and adherence to treatment plans. OARS also provides extensive tools to support patients with recovery from Opioid Use Disorder.
15730900|NCT05017259|Dietary Supplement|calorie restriction diet|The 7-day low-calorie diet contained 15.8 ± 0.4 kcal/kg/d in both trials, divided into three meals a day.
15730901|NCT05017246|Drug|Bupivacaine|-Epidural bupivacaine 0.1% 2-6ml/hr based on MAP within 10% of patient's baseline MAP
15730902|NCT05017246|Drug|Morphine|-Preservative-free intrathecal morphine (duramorph) 150mcg injection (0.15ml or a 0.5mg/0.5ml prepared solution)
15730903|NCT05017246|Drug|Lidocaine|-Lidocaine infusion 1 mg/kg ideal body weight (IBW)
15730904|NCT05017233|Device|Spectral CT|Using Spectral CT to scan Breast
15730905|NCT05017220|Other|Nature-based sensory stimuli|A program based on stimulation using nature-based sensory stimuli will be implemented
15730906|NCT05017220|Other|Control group intervention|An activity based on a placebo intervention will be implemented
15730907|NCT05017207|Procedure|Pancreaticoduodenectomy|Pancreaticoduodenectomy with one of 3 type of pancreatic-duodenal reconstructions
15730908|NCT05017194|Drug|Emodepside|Treatment with ascending doses of emodepside (from 5 mg to 30 mg) or albendazole (400 mg) or placebo.
15730909|NCT05017168|Drug|CT-P63|CT-P63 will be administered
15730910|NCT05017168|Drug|Placebo|Placebo-matching CT-P63
15730911|NCT05017155|Drug|Mexiletine|Mexiletine is a sodium channel blocker shown to be effective in reducing myotonia in a multi-centre randomised trial.
15730912|NCT05017155|Drug|Lamotrigine 25Mg Oral Tablet, Extended Release|Lamotrigine is an alternative sodium channel blocker that has been shown to be effective in one randomised controlled trial. It is currently used as a licensed medication for other neurological conditions.
15730913|NCT05017129|Behavioral|Inmates Care|The single intervention is a computer-based learning program.
15730914|NCT05017116|Drug|RBD1016|subcutaneous injection
15730915|NCT05017116|Drug|Placebo|subcutaneous injection
15730916|NCT05017116|Drug|Entecavir|Take orally.
15730917|NCT05017103|Biological|Sintilimab|Given IV
15730918|NCT05017090|Procedure|M-TAPA block|After tracheal intubation, a high-frequency linear probe will placed in the sagittal direction at the 10th costal margin, and transversus abdominis, internal oblique, and external oblique muscles will be identified. A block needle will inserted with in-plane technique and 25 ml 0.25 bupivacaine will be applied to the lower aspect of the chondrium. The same procedure will be repeated on the contralateral side.
15730919|NCT05017090|Other|Standard perioperative and postoperative multimodal analgesia|The pain intensity during rest and motion will be evaluated with the 0-10 Numeric Rating Scale (NRS). Patients will receive standard multimodal analgesia comprising paracetamol, tenoxicam, and tramadol.
15730920|NCT05017077|Device|DynaVision System|Telemonitoring for pediatric heart failure
15730921|NCT05017064|Device|Cryotherapy group|The use of intraoral ice pack during root canal treatment
15730922|NCT05017064|Other|Control group|No cryotherapy will be used
15730923|NCT05017051|Behavioral|Chocolate cake|The participants will have to make a chocolate cake following an imposed recipe at 4 visits (initially (M0), after 12 months (M12), after 24 months (M24) and after 36 months (M36)).
15730924|NCT05017051|Behavioral|Lego model|The participants will have to build a Lego model at 4 visits (M0, M12, M24 and M36).
15730925|NCT05017051|Device|Measurement of sensorimotor abilities|The measurement of sensorimotor abilities is based on a multi-sensor device called Smart Flat specifically designed for this study at 4 visits (M0, M12, M24 and M36).
15730926|NCT05017051|Other|Measurement of facial expression of emotions|Participants will have to evoke an emotionally charged autobiographical story by modulating facial expressions through a mirror at 4 visits (M0, M12, M24 and M36).
15730927|NCT05017025|Drug|Aurora A Kinase Inhibitor LY3295668|Given PO
15730928|NCT05017025|Drug|Osimertinib|Given PO
15730937|NCT05016999|Dietary Supplement|Garlic and onion concentrate|Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion)
15730938|NCT05016986|Other|Standard clinical management|outcomes in GSW cardiac injuries
15730939|NCT05016973|Drug|RC48-ADC|2.0mg/kg, Intravenous drip on days 1 every 21 days
15730940|NCT05016973|Drug|Triplizumab|240mg, Intravenous drip on days 1 every 21 days
15730941|NCT05016960|Behavioral|Sleep-SMART|Sleep-SMART will be a treatment for insomnia that will follow the standard 6 session 50-minute CBT-I format and will deliver CBT-I treatment along with training in select CogSMART strategies to enhance intervention learning and adherence. It will be delivered via video-based telehealth.
15730945|NCT05016934|Biological|A vaccine composed of a recombinant S1 antigen|Two applications of three different doses of a vaccine composed of a recombinant S1 antigen, a subunit of SARS-CoV-2 virus S protein
15730946|NCT05016921|Device|TcMS|Transcutaneous magnetic stimulation targeting the stellate ganglion
15730947|NCT05016895|Drug|Single-dose azithromycin|Bi-annual mass, community-based distribution of single-dose azithromycin to children ages 1 to 11 months.
15730954|NCT05016869|Drug|fruquintinib plus capecitabine|"Ⅰb: capecitabine: 1000 mg/m²，PO BID, d1-14，Q3W; fruquintinib 3mg/4mg/5mg, d1-14, PO QD, Q3W.
~ⅠⅠ: fruquintinib RP2D, d1-14, PO QD, Q3W, capecitabine: 1000 mg/m²，PO BID, d1-14，Q3W"
15730955|NCT05016856|Behavioral|Adherence Promotion With Person-centered Technology (APPT) System|A personalized and adaptive text message reminder system.
15730956|NCT05016856|Behavioral|Standard Reminder System (Active Control)|A typical text message reminder system.
15730957|NCT05016843|Behavioral|Treatment condition: Internet-administered Unified protocol|"Treatment condition:
~The cognitive, behavioral treatment Unified protocol is a transdiagnostic treatment for anxiety and depression. Participants are taught five techniques in order to find new and more helpful ways to react to hindering thoughts and feelings: mindfulness, cognitive flexibility, identify and reduce behavioral avoidance, increase willingness to experience physiological sensations and exposure. The intervention is delivered online through a secure platform. Modules consist of text and the participants can work with the material whenever they wish to. Participants gain access to a new treatment modul every week."
15731049|NCT05016154|Behavioral|Online Group CBT intervention|Group of participants complete 10 weeks of Online Group CBT intervention
15730958|NCT05016843|Behavioral|Treatment condition: Internet-administered Affect phobia treatment|The aim of psychodynamic Affect phobia treatment is for the patient to reach an intellectual and emotional understanding of his/hers problems. The goal of the treatment is for participants to decrease emotional avoidance and start to approach emotions and increase emotional awareness. Participants are taught this through linking their symptoms to their emotional avoidance, observe frequent and maladaptive patterns in relationships and see how these are linked to emotional avoidance. The intervention is delivered online through a secure platform. Modules consist of text and the participants can work with the material whenever they wish to. Participants gain access to a new treatment modul every week.
15730959|NCT05016843|Other|Treatment condition: Waitlist control|The waitlist condition is a control condition without any intervention.
15730960|NCT05016843|Other|Treatment length: 8 weeks|Participants will partake in their treatment condition for 8 weeks.
15730961|NCT05016843|Other|Treatment length: 16 weeks|Participants will partake in their treatment condition for 16 weeks.
15730962|NCT05016843|Other|Access to a moderated forum|During their treatment, participants will have access to a discussion forum moderated by a clinician. Participants are encouraged to discuss questions and experiences related to their treatment condition.
15730963|NCT05016843|Other|No access to a moderated forum|Participants will not have access to a moderated forum, hence their treatment is self-guided.
15730964|NCT05016830|Device|Bilateral transcranial direct current stimulation|A direct current is applied with two electrodes (cathode and anode) in specific parts of the skull. In this case the anode was over the occipital area to target the amblyopic cortex, while the cathode was over the contralateral side, targeting the fellow cortex.
15730965|NCT05016817|Biological|AlloRx|cultured allogeneic adult umbilical cord derived mesenchymal stem cells
15730966|NCT05016804|Biological|AlloRx|cultured allogeneic adult umbilical cord derived mesenchymal stem cells
15730967|NCT05016791|Device|Apple Watch-based heart rhythm monitoring|"For the duration of the study, participants in the active arm will be asked to make ECG recordings in three circumstances:
~Routinely once per day from the day of randomisation till the 12-month visit after AF CA (they will be encouraged to do so at the same time each day with the option to set a reminder on the watch).
~If the AW requests them to do so (the automatic AF-notification algorithm will be active throughout the study period and if AF is suspected based on the tachogram, it will trigger notification for the participant to make an ECG recording). This will be till the 12-month time point.
~If the patient has symptoms of palpitations, pre-syncope or syncope. This will be till the 12-month time point. Monitoring should continue even if AF has been diagnosed to characterise arrhythmia burden and profile. Participants will be given the contact details of a dedicated email inbox to which to send ECGs recorded through the AW."
15730968|NCT05016791|Device|FreeStyle Libre Continuous Glucose Monitoring biosensor (CGM)|Participants in the active study arm with paroxysmal AF will be asked to wear the CGM patch for 14 days, commencing from 10 days prior to their AF CA date. They will be asked to repeat the administration of this patch again at their 6 month follow-up appointment
15730969|NCT05016778|Drug|GPRC5D-CAR-T|After enrollment, subjects complete the PBMC apheresis, then complete the Lymphocyte clearance, and then receive the dose climbing test: 1×10e6/kg，3×10e6/kg，6×10e6/kg.
15730971|NCT05016739|Device|CADISS|"The CADISS® device was procured from AuXin Surgery. It consists in three elements:
~A single use disposable Remote Kit, containing a sterile cartridge, which prepares the Drug Product immediately before use, and the sterile tubing for fluid connexion. The Drug Product is a 30 ml sterile 5% mesna solution of pH 7.3+/-0.5
~Reusable stainless steel non-cutting mechanical instruments similar to those used in the normal practice, except for the provision of an internal irrigation channel bringing the Drug Product at the working edge.
~A pedal controlled electric motor driving the peristaltic cassette included in the disposable tubing in order to control the dispensing of the Drug Product during the procedure."
15730972|NCT05016726|Device|Intravascular Lithotripsy|Intravascular Lithotripsy and/or Rotational Atherectomy and/or Orbital Atherectomy to the target vessel prior to placing a coronary stent.
15730973|NCT05016713|Combination Product|Chlorhexidine mouthwash|"Chlorhexidine mouthwash is added to the oral hygiene protocol being used beside fluoride-based toothpaste and interdental brushes. CHX mouthwash is used by patients according to the manufacturer's instructions 15 min after tooth-brushing: 5 mL of 0.2% CHX was applied for 60s in the morning and at bedtime. The patients will be instructed not to consume any liquid or food at least 30 min after using the prescribed mouthwash. All patients are asked to bring the mouthwash bottle, so we could determine patient compliance based on how much liquid was left.
~If any participant shows any signs of CHX hypersensitivity, the intervention will be discontinued."
15730974|NCT05016713|Device|Interdental brush|Fluoride-based toothpaste is used for tooth-brushing beside using interdental brushes.
15730975|NCT05016713|Other|Fluoride-based toothpaste|Regular tooth-brushing is carried out using fluoride-based toothpaste supplied only.
15730976|NCT05016700|Diagnostic Test|blood sample|we want to identify a diagnostic option to identify patients, who have a neuropathological distraction of their ganglia cells in the bowel
15730977|NCT05016687|Drug|CUR-N399|CUR-N399 will be administered as oral capsules.
15730978|NCT05016687|Drug|Placebo|Placebo capsules matching CUR-N399 will administered.
15730979|NCT05016674|Device|LipoLife system|Abdominal Laser-Assisted Liposuction
15730980|NCT05016661|Drug|ABP-450|ABP-450 (prabotulinumtoxinA) contains a 900 kDa botulinum toxin type-A complex produced by the bacterium Clostridium botulinum.
15730981|NCT05016622|Biological|BNT162b2 vaccine|administer an additional dose of the BNT162b2 mRNA vaccine to patients with cancer who have a negative SARS-CoV-2 Spike IgG at least 14 days after 2 doses of the mRNA vaccines (BNT162b2/mRNA-1273) or 28 days after the adenoviral based Ad26CoV2.S vaccine.
15731050|NCT05016154|Behavioral|SilverCloud guided|Group of participants make use of the SilverCloud guided app
15731051|NCT05016154|Behavioral|SilverCloud Unguided|Group of participants make use of the SilverCloud Unguided app
15730982|NCT05016609|Device|OraQuick HCV Antibody test (OraSure Technologies, Inc)|The OraQuick HCV test is a point of care antibody test for detecting HCV antibodies in fingerstick blood. The test takes 20 minutes to provide a result. Appropriate pre- and post-test counselling will be provided to participants.
15730983|NCT05016609|Device|Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid)|Xpert® HCV VL Fingerstick is an in vitro reverse transcription polymerase chain reaction (RT-PCR) assay for the detection and quantification of Hepatitis C Virus (HCV) RNA in human venous and capillary fingerstick EDTA whole blood. Only participants who return a reactive OraQuick HCV Antibody test will be offered the Xpert® HCV VL Fingerstick test. Appropriate pre- and post-test counselling will be provided to participants.
15730984|NCT05016609|Drug|Sofosbuvir/Velpatasvir (Gilead)|Participants with a detectable HCV antibody will be offered treatment with sofosbuvir/velpatasvir.
15730985|NCT05016596|Dietary Supplement|turmeric|High bioavailable turmeric supplement (300mg)
15730986|NCT05016583|Other|Paula Method|12 weeks of Paula Method of Exercises
15730990|NCT05016557|Dietary Supplement|Protein ingestion|Bolus ingestion of 25g protein
15730991|NCT05016544|Drug|inetetamab|All dose levels will receive 8 mg/kg loading dose for cycle 1, followed by 6 mg/kg in subsequent cycles, every 3 weeks.
15730992|NCT05016544|Drug|Pytotinib|"Starting pytotinib Dose of 240mg:
~Cohort 1: pyrotinib 240mg p.o. d1 to d21, q3w; Cohort 2: pyrotinib 320mg p.o. d1 to d21, q3w; Cohort 3: pyrotinib 400mg p.o. d1 to d21, q3w."
15730993|NCT05016531|Device|Low Intensity Focused Ultrasonic Stimulation|Brain stimulation using ultrasonic stimulation in a sequence of increasing intensity (sham, 1 W/CM2, 2 W/CM2, 4 W/CM2, 6 W/CM2, 8 W/CM2)
15730994|NCT05016531|Device|Low Intensity Focused Ultrasonic Stimulation Frequency|Brain stimulation using ultrasonic stimulation of intensity level determined from intervention 1 at progressively increasing frequency levels (0.35 MHz; 0.5 MHz; 0.75 MHz, 1.0 MHz and 1.5 MHz)
15730995|NCT05016518|Drug|Arm I (Propofol group)|Propfol group will be started and maintained total intravenous anesthesia with propofol and remifentanil under target controlled infusion (TCI) model.
15730996|NCT05016518|Drug|Arm II (Remimazolam group)|Remimazolam group will be started total intravenous anesthesia with remiamazolam at 6 mg/kg/h for induction, and maintained at 0.5-1.5 mg/kg/h and remifentanil under TCI model.
15730997|NCT05016505|Behavioral|Relocation & Cessation|Individual-level. COW to provide cessation and/or relocation support.
15730998|NCT05016505|Behavioral|Resident Endorsement|Building-level. COW to conduct building-level sessions.
15730999|NCT05016492|Device|Visual-perceptual interactive game system|Subjects received 30-min interactive digital game training session per week. The game system contain 7 skills training, each of which was named according to the corresponding TVPS-3.
15731000|NCT05016492|Behavioral|standard rehabilitation|Subjects received the standard 4-week course of rehabilitation delivered in one 30-min session per week. The course of rehabilitation included: sensory integration therapy, cognitive function training and visual perception/auditory attention training.
15731002|NCT05016466|Other|Standard Care|Patients will followed during 5 years, and only 2 visits , baseline and 5 years
15731003|NCT05016466|Other|Standard Care plus oxidative stress study plus inflammation biomarkers study|Patients will followed during 5 years, Annual follo-up visits will be carried out during this period
15731004|NCT05016440|Drug|Lisinopril|10mg Lisinopril daily for 6-8 weeks postpartum
15731005|NCT05016427|Biological|VT301|VT301 is off-white suspension of regulatory T cells (Tregs) (1.7x10^5 cells/kg±15%) for injection diluted with sterile saline solution and supplied in clear, colorless, polypropylene vials.
15731006|NCT05016414|Other|Lower body negative pressure|lower body negative pressure at -20mmHg delivered via a custom designed sleeping sack
15731007|NCT05016401|Device|KONTACT PERIO LEVEL (KPL)|The Kontact™ Perio Level is an implant with a transgingival neck that facilitates one-step surgery.
15731008|NCT05016388|Other|Collaborative Multidimensional Model (CMD)|The teams enrolled in the CMD intervention will have a 22-hour training that integrates current knowledge of depression with skills for the management of functional variables, interpersonal, social, emotional regulation, and history of biographical adversity from childhood considering the trauma informed care paradigm. After the training, the PHC teams will implement the depression treatment according to a collaborative model.
15731009|NCT05016388|Other|Standard Model (SM)|The teams enrolled in the SM intervention will have a 22-hour training that integrates the current national clinical guide for Depression in Chile. This guide offers a staggered treatment according to the severity of the depression. After the training, the PHC teams will implement the depression treatment according to the SM.
15731010|NCT05016375|Other|Interview|Interview with individuals with T2DM
15731011|NCT05016362|Procedure|medial fat preservation upper blepharoplasty|medial fat preservation upper blepharoplasty increasing volumetric upper eyelid skin fold
15731012|NCT05016349|Drug|All trans-retinoic acid|Vesanoid will be supplied orally at the total dosage of 45mg/m2/d (two daily administrations of 22.5 mg/m2 each). Treatment will last 28 days
15731013|NCT05016349|Drug|13-Cis Retinoic Acid plus Tocopherol|13-Cis Retinoic Acid (50 mg/m2/d) Tocopherol (800 mg/day) supplied orally at the total dosage of 50 mg/m2/d (two daily administrations of 25 mg/m2 each). Treatment will last 28 days
15731014|NCT05016349|Drug|Mifepristone|Mifepristone 200mg capsules daily for 28 days
15731015|NCT05016349|Drug|Cannabidiol|Liquid taken orally for daily for 28 days
15731016|NCT05016349|Drug|9 cis retinoic acid|9 cis retinoic acid will be supplied orally at the total dosage of 45mg/m2/d (two daily administrations of 22.5 mg/m2 each). Treatment will last 28 days
15731017|NCT05016349|Drug|Tamoxifen|Patients will be given 10mg Tamoxifen twice a day. Treatment will last 28 days
15731018|NCT05016349|Drug|Standard therapy|Patients will receive the approved standard therapy tamoxifen
15731019|NCT05016336|Other|Social interaction combined with cognitive training based on mnemonic strategies.|In the first six sessions, participants in the experimental group learned and practiced six different mnemonic strategies: Story-Formation strategy, Face-Name strategy, Peg-Word strategy, Chunking strategy, Key-Word strategy and the Method of Loci. In the following six sessions, in order to assimilate the strategies they learned, participants practiced the same tasks.
15731020|NCT05016336|Other|Social interaction group|In the control group, each session also began with a conversation between the participants. The sessions then dealt with the content of interpersonal communication and the acquisition of tools for creating interpersonal relationships. Participants were asked to share the way they used the tools they acquired between sessions and received feedback from the other participants
15731021|NCT05016323|Drug|HR19042 Capsules|HR19042 Capsules
15731022|NCT05016323|Drug|Placebo|Placebo
15731023|NCT05016310|Drug|High Dose Vitamin D|High dose vitamin D: Subjects will receive 50,000 IU vitamin D2 weekly x 16 weeks followed by 4,000 IU of vitamin D3 daily with a goal 25(OH)D level of ≥45 but ≤80 ng/mL.
15731024|NCT05016310|Drug|Standard of Care Vitamin D|Standard of Care Vitamin D: Vitamin D will be supplemented to 25(OH)D levels, with a goal 25(OH)D level of >30 ng/mL according to Endocrine Society Practice Guidelines.
15731025|NCT05016297|Drug|Baricitinib|baricitinib 4mg per day
15731026|NCT05016297|Drug|Hydroxychloroquine|Hydroxychloroquine 200mg twice a day
15731029|NCT05016271|Behavioral|Air purifier and fresh air ventilation systems with high-efficiency particulate air (HEPA) filters|This group will receive an intervention of true air purifiers. The air purifiers in classroom (air purifiers and fresh air ventilation systems with HEPA filters) will operate during the school time and the air purifiers in bedrooms (air purifiers with HEPA filters) operate during the home time in the intervention period (4 months anticipated).
15731030|NCT05016271|Behavioral|Air purifier and fresh air ventilation systems without high-efficiency particulate air (HEPA) filters|This group will receive an intervention of sham air purifiers. The air purifiers in classroom (air purifiers and fresh air ventilation systems without HEPA filters) will operate during the school time and the air purifiers in bedrooms (air purifiers without HEPA filters) operate during the home time in the intervention period (4 months anticipated).
15731031|NCT05016258|Device|KONTACT MB|Dental implant surgery
15731034|NCT05016232|Behavioral|PrEP N' Shine: Strength Based Case Management (Stage 1)|Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.
15731035|NCT05016232|Behavioral|PrEP N' Shine: Stepped Adherence Training and Counseling (Stage 2)|"Initially TGW in this arm will receive daily 2-way gender-affirming text message reminders, and
~Then those continuing to have poor adherence will receive the 4 (once per week for 3 to 4 weeks) more intensive counseling session with a clinical interventionist."
15731036|NCT05016219|Device|Circadian-Effective Light|Narrowband blue light
15731037|NCT05016219|Device|Rhythmic Light|40 hertz (Hz) flicker
15731038|NCT05016219|Device|Placebo Light|Narrowband red light
15731039|NCT05016219|Device|Placebo Rhythmic Light|Random flicker for placebo rhythmic effect
15731040|NCT05016206|Drug|Danicopan|Danicopan tablets administered as a single oral dose.
15731041|NCT05016206|Drug|Moxifloxacin-matching Placebo|Moxifloxacin-matching placebo was administered as a single oral dose.
15731042|NCT05016206|Drug|Danicopan-matching placebo|Danicopan-matching placebo was administered as a single oral dose.
15731043|NCT05016206|Drug|Moxifloxacin|Moxifloxacin 400 mg was administered as a single tablet oral dose.
15731044|NCT05016193|Device|Axem Home Prototype Device|The Axem Home prototype device is a rehabilitation system designed to be used independently by a stroke survivor to facilitate physical rehabilitation exercises in their home environment. The device uses a functional near-infrared spectroscopy (fNIRS) headband that measures the hemodynamic response to rehabilitation exercises and displays this brain activity information to the user.
15731045|NCT05016193|Behavioral|Rehabilitation Exercise Program|Individual exercise program prescribed by a therapist in the Early Supported Discharge Program.
15731046|NCT05016180|Drug|Ropivacaine|Before the induction of anesthesia, ropivacaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side
15731053|NCT05016141|Behavioral|digital fall prevention program|The participants will receive a digital fall prevention program consisting of fall risk reduction education (modified Matter of Balance), Otago Exercise Program, Personalized S.M.A.R.T Goals, and will use the app to keep track of their health and health events, including falls.
15731054|NCT05016128|Drug|S-ketamine|S-ketamine is used for preventing postoperative hyperalgesia,thus reducing the patient's acute postoperative pain
15731055|NCT05016128|Drug|saline|saline is used for control
15731056|NCT05016115|Behavioral|survey|The Turkish reworded student version of the Jefferson scale of physician empathy was used. Empathy scores were compared related to study years and gender.
15731057|NCT05016102|Other|Exercise type|Aerobic exercise and Resistance exercise
15731058|NCT05016089|Other|The 16-style simplified Pilates exercise programme|The 16-style simplified Pilates exercise programme was developed by a group of experienced Pilates and rehabilitation experts from our completed pilot work.
15731059|NCT05016076|Drug|Dexamethasone 8 mg|In the designated patients, 8 mg of dexamethasone or placebo will be given intravenously within 10 minutes after the induction of anesthesia.
15731060|NCT05016076|Diagnostic Test|Applied inspiratory pressure (10, 15, 20, or 25 cmH2O)|A two-handed head-tilt jaw-thrust maneuver will be performed to establish an open airway. Once apnea determined by end-tidal capnography occurs, a mechanical ventilation with the assigned peak inspiratory pressure will be initiated. The pressure-controlled mode will be used with an inspiratory-to-expiratory ratio of 1:2 and no positive end-expiratory pressure (PEEP), at a frequency of 15 breath·min-1 and with 100% oxygen, by the ventilator (Carestation 620, Datex-Ohmeda, Inc., Madison, WI, USA).
15731061|NCT05016076|Device|Tracheal intubation using video intubating stylet, video laryngoscopy, or direct laryngoscopy|In video intubating stylet group, a tracheal tube (ConvaTec, Berkshire, England, UK) in appropriate sizes is preloaded over the Trachway® video intubating stylet (TVI-4050, Markstein Sichtec Medical Corp, Taichung, Taiwan), which is introduced into oral cavity to visualize the epiglottis and guided to glottis via a monitor after full neuromuscular blockade is achieved. In video laryngoscopy group, a tracheal tube is preloaded over a GlideRite® stylet, which is specifically designed to work with GlideScope® video laryngoscope (Verathon Medical, Bothell, WA, USA). GlideScope® blade size 3 (GS-3) or 4 (GS-4) is used in all patients. In direct laryngoscopy group, tracheal tubes are prepared with a hockey stick-shaped stylet, and direct laryngoscopy is performed using a size-3 or -4 Macintosh blade (Rüsch Inc., Duluth, GA, USA).
15731062|NCT05016076|Device|Goal-directed hemodynamic therapy targeting cardiac index|Subjects of the GDHT group will be managed according to the ERAS algorithm utilizing ProAQT® parameters to maintain the cardiac index ≥ 2.5 l·min-1·m-2. In brief, if cardiac index < 2.5 l·min-1·m-2, a bolus of 150 ml of crystalloid fluid will be given until the stroke volume variation is < 10%. If cardiac index < 2.5 l·min-1·m-2 despite the stroke volume variation of ≥ 10% following fluid challenge, continuous intravenous infusion of dopamine 5-10 μg·kg-1·min-1 will be administered. If mean arterial pressure is < 70 mmHg despite cardiac index ≥ 2.5 l·min-1·m-2, intravenous infusion of norepinephrine 2-10 μg·min-1 will be used.
15731063|NCT05016076|Drug|Placebo (0.9% sodium chloride)|Placebo of 0.9% sodium chloride will be given intravenously within 10 minutes after the induction of anesthesia.
15731064|NCT05016063|Drug|Fludarabine|recommendation: 30mg/m2 (D-5~D-3),determined by tumor burden at baseline.
15731065|NCT05016063|Drug|Cytoxan|recommendation: 300-500mg/m2 (D-5~D-3),determined by tumor burden at baseline.
15731066|NCT05016063|Biological|Dual CD33-CLL1 CAR-T cells|CD33-CLL1 CAR-T infusion (starting at dose level 1 [DL1]: 0.5 x 106 transduced CAR-T cells/kg) on Day 0.
15731067|NCT05016050|Device|HPDT-DA-013|Digital program with therapeutic interventions based on Cognitive Behavioral Therapy (CBT).
15731068|NCT05016037|Behavioral|Lexically based speech recast|a child's spontaneous or elicited production containing phonological errors is immediately followed with a clinician model that corrects the error(s) at the word level rather than the isolated phoneme level. As an example, a speech recast of child's production of the word bake as [be] would be the whole lexeme bake [bek] rather than production drill on [k] in isolation.
15731069|NCT05016024|Device|Colilen IBS|Patients will take Colilen IBS in First or Second Period
15731070|NCT05016024|Other|Placebo|Patients will take PlaceboS in First or Second Period
15731071|NCT05016011|Biological|Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs)|Human umbilical cord-derived mesenchymal stem cells
15731072|NCT05016011|Procedure|Marrow cellution|Patients will undergo marrow cellution surgical procedure.
15731074|NCT05015985|Other|Music-Care|music relaxation by a specific hardware and software program application (MUSIC-CARE)
15731075|NCT05015985|Other|control group|music relaxation using a music playlist supply (control group)
15731076|NCT05015972|Biological|CTA30X UCAR-T injection|CTA30X UCAR-T injection is an allogeneic CAR-Ttargeted CD19 . A single infusion of CART cells will be administered intravenously.
15731077|NCT05015959|Other|observation|quality
15731078|NCT05015946|Behavioral|Small-sided team handball training|60 minutes small-sided team handball training. Initial 20 minutes of warm-up including exercises for strength, aerobic, balance, coordination, and mobility. Hereafter 20 minutes of handball specific exercises including dribbling, running and shooting. Final 20 minutes of small-sided handball matches.
15731079|NCT05015933|Procedure|Pump refill procedure at home|Implantable pump refill is performed at home
15731080|NCT05015920|Genetic|BD211 Drug Product|Transplantation of Autologous CD34+Stem Cells Transduced to BD211 finished Product with a Lentiviral Vector coding βA-T87Q-Globin.
15731081|NCT05015907|Drug|Ropivacaine|The nerve involved in the operation of Hickman catheter, chemoport, and Perm cath is the supraclavicular nerve. Therefore, it is judged that if only this nerve is selectively blocked, pain control can be effectively performed with a small amount of local anesthetic, and relatively few side effects occur.
15731082|NCT05015907|Other|Control (without intervention)|No intervention
15731083|NCT05015894|Drug|NNC0480-0389|"A single dose of 18 mg NNC0480 0389 administered subcutaneously (under the skin).
~Total duration of study participation for each participant is 38 to 66 days"
15731084|NCT05015881|Dietary Supplement|"Ketone Ester (R)-3-hydroxybutyl (R)-3-hydroxybutyrate"|Drink a single dose of ketone ester 1.9 kcal/kg
15736494|NCT04972513|Procedure|Spirometry|Undergo spirometry
15731085|NCT05015881|Drug|FDG|Echocardiogram, and 2-Deoxy-2-[18F] fluoro-D-glucose (FDG) PET scan.
15731086|NCT05015868|Diagnostic Test|Standard of care|"Enrollment of patients afferent to our Center with cryptogenic drug-resistant epilepsy with onset in pediatric age, subject to informed consent;
~acquisition and updating of Electroencephalogram polygraphic data of wakefulness and sleep and neuroradiological data (previous negative brain magnetic resonance imaging);
~execution of a complete neuropsychological assessment for the classification of cognitive aspects and evaluation of executive functions;
~execution of genetic tests through Next generation sequencing epilepsies panel or exome sequencing"
15731087|NCT05015868|Diagnostic Test|Functional magnetic resonance imaging-Electroencephalogram combined analysis|"A functional brain magnetic resonance imaging is executed analysing blood oxygenation level dependent signal.
~During the functional recording, a contemporary electroencephalogram is registered in order to analyse the space-time relationship between the epileptic discharges and the bold abnormalities."
15731088|NCT05015868|Diagnostic Test|High density- electroencephalogram or 7 Tesla magnetic resonance imaging|"In the event that neither the cause nor the epileptogenic area has been identified, we will evaluate the execution of further tests, such as:
~execution of High Density-electroencephalogram recording at IRCCS Medea di Conegliano (TV, Italy) (approximately 3 patients / year) for a further electrophysiological definition;
~7 Tesla brain magnetic resonance imaging performed at IRCCS Stella Maris in Calambrone (PI, italy) (approximately 3 patients / year expected), to obtain greater spatial resolution and better neuroradiological definition."
15731089|NCT05015855|Other|NP-PC PrEP|All participating providers will be provided standard education around PrEP and HIV prevention, but half of the providers will be randomized to also partner with a nurse practitioner who will provide additional consultation to patients.
15731090|NCT05015855|Other|OBGYN-PrEP|"OBGYN-PrEP is based on PC4PrEP (R01MH107297) that has four steps: announce the policy that PrEP counseling is the responsibility of OBGYN providers to address the purview paradox; train providers to manage patients on PrEP; use a screening tool to identify women appropriate for PrEP; and implementation coaching to monitor and encourage PrEP counseling"
15731091|NCT05015842|Other|Conventional Physical Therapy|This is a combine protocol of different therapeutic exercises and heat therapy.
15731092|NCT05015842|Other|Kinesio Tapping|Kinesio Tapping is an adhesive and elastic fiber used for different outcomes like pain and swelling reduction among physical therapists.
15731093|NCT05015829|Diagnostic Test|Dobutamine Stress Echocardiography|Change in echocardiographic 2D and doppler measurements during infusion with Dobutamine 5 µg/kg/min till max dosage of 20 µg/kg/min.
15731094|NCT05015816|Diagnostic Test|Total body photography|3 monthly TBP imaging
15731095|NCT05015803|Combination Product|CBTi (with sleep diary app/dashboard + IoT)|Participants randomized to this study arm will experience an attempted enhancement of standard video conferencing CBTi, that is facilitated with electronic device-based intervention (IoT) and data resources to the clinician. Noninvasive ambulatory worn and nearable devices deliver real-time feedback of objective data to the clinician on an application interface. Subjective data collected using the application are available live to both the clinician and patient. This information will be used to inform the therapeutic approach. Environmental cues and notifications are programmed into IoT devices to remind patients of their behavioral prescription, to permit live clinician updates and clinician-patient communication, and to create a living-space environment that is conducive to effective therapy.
15731096|NCT05015803|Behavioral|CBTi|Participants randomized to this study arm will experience standard CBTi that is delivered via video conferencing by a clinician. They will use a typical paper-based sleep diary, without intentional enhancement by our electronic application/dashboard, nor environmental and prescription reminder cues, nor live ambulatory device feedback for the clinician.
15731097|NCT05015803|Other|Sleep Hygiene education|Participants randomized to this study arm will experience sleep hygiene education and training, without CBTi. Sleep hygiene education discussion with the clinician may include sharing and review of the NIH's free accessible booklet, Sleep and Older Adults.
15731098|NCT05015790|Device|virtual reality Bliss Solution|use virtual reality Bliss Solution
15731099|NCT05015777|Other|Emil Jaques-Dalcroze's Eurhythimcs Exercise Program|"Training sessions took place twice a week for 45 minutes each over a period of 12 weeks. Each training included rhythmic exercises using the Jaques-Dalcroze Eurhythmics (JDE) method with piano accompaniment and electronically played music. Training sessions were conducted by a JDE specialist.
~Exercises with the use of this method consist mainly in the repetition of preset musical sequences using body movements. In addition to the physical layer, the cognitive layer was equally important: while performing a given movement exercise, participants often had to focus in order to react appropriately to additional tasks, such as changes in sound pitch and rhythm of the piece."
15731100|NCT05015764|Other|Fluid Management|Removal of excess extracellular fluid using diuretics
15731101|NCT05015764|Device|Reprieve Cardiovascular System|System with Fluid Management Module
15731102|NCT05015751|Device|Thermal Anisotropy Measurement Device|A wireless device for non-invasively assessing CSF shunt flow.
15731103|NCT05015738|Other|Traditional education|Diabetes education will be given by the trainer for 10 weeks, 2 hours of presentation.
15731104|NCT05015738|Device|Diabetes Education supported by digital tools|Diabetes education will be given for 10 weeks with 2-minute animations. At the end of the course, learners' knowledge was measured with a knowledge test using the Kahoot app.
15731105|NCT05015725|Diagnostic Test|Quality of life assessment, biochemical measures|"Psychological tests: ThyDQol, ThySRQ and the Somatosensory Amplification Scale (SASS) adding up to ~50 items including demographic variables.
~Recording of basic anthropometric data. Blood draw Laboratory tests: TSH, T3, FT3, FT4, aTPO, rT3, serum cholesterol, CK, GOT, GPT, creatinine and sodium levels."
15731136|NCT05015569|Device|COVR Medical Garment|"COVR undergarments are available in a Half Short design for unilateral lower extremity procedures and a Bilateral (brief) style garment designed for bilateral lower extremity procedures. Either style may be worn for upper extremity, trunk, spine procedures, etc. where an undergarment would be preferred along with a standard hospital gown. The garments are available in a variety of sizes. The COVR garments can be released at the hip(s)/waistline for improved access to the lateral hip and include retractable panels for procedural access to the groin and genitals if needed by the care team."
15731137|NCT05015569|Other|Standard Patient Gown|The standard patient gown is provided to all patients in a hospital setting.
15736495|NCT04972513|Other|Survey Administration|Complete survey
15731106|NCT05015712|Behavioral|moderate intensity continuous training|Moderate intensity continuous training was scheduled 3 times per week for 3 months. Every sessions included warm-up (<50% target intensity for 2 min then gradually increasing load 1-10 W/min up to 100% target intensity for 5-10 min), exercise phase (100% target intensity (heart rate at anaerobic threshold±5) starting with 20 min and gradually lengthening up to 45 min in the 1 month as well as 45 min in another 2 months), cool down with gradual reduction of load within 3 min. The target intensity will be determined by the heart rate at anaerobic threshold measured by cardiopulmonary exercise test (CPET). The intensity will be adjusted after implementation of CPET and will keep at a minimum intensity, gradually increasing to the maximum intensity every month. Moreover, patients will be instructed to complete 2 supervised sessions and 1 home-based session during the 1 month and then to continue 3 home-based session for a further 2 months.
15731107|NCT05015699|Device|HT Supreme|HT Supreme ( R&D by Sinomed, Tianjin, China)
15731108|NCT05015686|Biological|Live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd|live varicella-zoster virus in 0·5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection
15731109|NCT05015686|Biological|Live attenuated varicella vaccines manufactured by Changchun BCHT Biotechnology Co.,Ltd|live varicella-zoster virus in trehalose,human serum albumin,sodium glutamate,sucrose,glucose,carbamide,arginine and injection water per injection
15731110|NCT05015686|Biological|Live attenuated varicella vaccines manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd|live varicella-zoster virus in 0·5 mL of sucrose, sodium glutamate,sodium chloride,potassium chloride,sodium dihydrogen phosphate, potassium dihydrogen phosphate and injection water per injection
15731111|NCT05015686|Biological|Placebo|Sodium chloride and distilled water
15731112|NCT05015673|Drug|SEP363856|
15731113|NCT05015673|Drug|Placebo|
15731114|NCT05015660|Device|Left bundle branch pacing lead (Select Secure 3830 lead)|Implantation of a left bundle branch pacing lead via sheath, to perform selective or non-selective pacing
15731115|NCT05015660|Device|Right ventricular active fixation lead|Active fixation lead (standard)
15731116|NCT05015647|Dietary Supplement|LP group|LP group patients replaced pasta, bread, biscuits etc. with low protein substitutes. We allowed them to consume more animal products than NP, preferring white meat to red meat and trying to limit cold cuts as much as possible. Furthermore, they were advised to prefer fresh or frozen fish, instead of dried or smoked one as well as to prefer fresh cheeses to seasoned ones. As for legumes, we advised to combine them with bread or normal cereals, for protein complementarity.
15731117|NCT05015647|Other|NP group|NP group was given the indication to try to eat the second dish only once a day or to split the portion of the second plate between lunch and dinner, if they wanted to keep the habit of making the meal complete. It was also given the indication to prefer, among protein sources, those of plant origin. We also indicated to alternate or replace cow's milk with plant substitutes such as: rice, almonds' or oats' drinks. Furthermore, we suggested to prefer white meat and to avoid offal and processed meat. Moreover, we indicated to substitute dried or smoked fish with fresh or frozen one.
15731118|NCT05015634|Other|Active Arm|Patient develops possible cardiac symptoms, takes an ECG, BP and oxygen saturation as per their training. Patient will receive a phone call by the trial cardiologist who will have access to a high-quality ECG trace, as well as blood pressure and oxygen saturations, and coupled with the clinical history, can decide on the most appropriate course of further management. With remote follow up over the phone at 3, 6 and 9 months.
15731119|NCT05015634|Other|Control Arm|Standard routine clinical care will be carried out, with remote follow up over the phone at 3, 6 and 9 months.
15731120|NCT05015621|Drug|Surufatinib plus Toripalimab|Surufatinib is a tablet in the form of 50mg, oral, once a day; Toripalimab is an injection in the form of 240mg, intravenous, once three weeks.
15731121|NCT05015621|Drug|5-fluorouracil, Calcium folinate and Irinotecan|Irinotecan 180 mg/m^2, Calcium folinate 400 mg/m^2, 5-FU total 2800 mg/m^2 will be administrated once two weeks.
15731122|NCT05015608|Drug|Savolitinib + Osimertinib|Subjects will receive Savolitinib orally once per day (QD) + Osimertinib orally QD,21day cycles (every 3 weeks) until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
15731123|NCT05015608|Drug|Pemetrexed + Cisplatin /Carboplatin|Pemetrexed combined with platinumon on Day 1 of 21day cycles (every 3 weeks)
15731124|NCT05015595|Drug|Memantine Oral Tablet|Thirty-two-week double-blind up-titration treatment period (from T0 to T4): patients will be randomly assigned to one of two arms (Memantine or placebo) in a 1:1 ratio and will receive a daily administration of Memantine/placebo up to 20mg/day. Eight-week double-blind down-titration treatment period (from T4 to T5): At T4, the dose of Memantine/placebo will be reduced at 10mg/day due to safety reasons before the end of treatment (T5).
15731125|NCT05015595|Drug|Placebo|Thirty-two-week double-blind up-titration treatment period (from T0 to T4): patients will be randomly assigned to one of two arms (Memantine or placebo) in a 1:1 ratio and will receive a daily administration of Memantine/placebo up to 20mg/day. Eight-week double-blind down-titration treatment period (from T4 to T5): At T4, the dose of Memantine/placebo will be reduced at 10mg/day due to safety reasons before the end of treatment (T5).
15731126|NCT05015582|Device|Pre op upper body forced air warming (32˚C)|Use of upper body forced air warming at ambient (32˚C) for at least 30 minutes
15731127|NCT05015582|Device|Pre op lower body forced air warming (32˚C)|lower body forced air warming at ambient (32˚C) for at least 30 minutes
15731128|NCT05015582|Device|Pre op fluids (45˚C)|fluids from warmed cabinet set at 45˚C
15731129|NCT05015582|Device|Intra op upper body forced air warming (32˚C)|Use of upper body forced air warming intra-operative at ambient (32˚C)
15731130|NCT05015582|Device|Intra op fluids at room temperature|IV fluids at room temperature
15731131|NCT05015582|Device|Intra op upper body forced air warming at (32˚C)|upper body forced air warming intra-operative at ambient (32˚C)
15731132|NCT05015582|Device|Intra op upper body forced air warming at (42˚C)|upper body forced air warming intra-operative at ambient (42˚C)
15731133|NCT05015582|Device|Intra op lower body forced air warming at (32˚C)|Lower body forced air warming intra-operative at ambient (32˚C)
15731134|NCT05015582|Device|Intra op lower body forced air warming at (42˚C)|Lower body forced air warming intra-operative at ambient (42˚C)
15731135|NCT05015582|Device|Intra op fluid (42˚C)|IV fluids with hotline fluid warmer set at 42˚C
15731138|NCT05015556|Procedure|Minimal invasive volar plating|Muscle sparing osteosynthesis, no casting postoperatively
15731139|NCT05015543|Other|Personal Training Program|One training sessions includes an interval training on a bicycle ergometer. The second one is a strength training with exercise machines. Both trainings are supplemented by coordinative aspects.
15731140|NCT05015530|Device|Healsea® Chronic, hypertonic seawater-based nasal spray supplemented with natural Symbiofilm® extract|Healsea® Chronic nasal spray will be administered twice daily (1 puff, 1-2 sec) in each nostril during 30 days
15731141|NCT05015517|Procedure|Erector spinae plain block|Patients will be placed in the lateral position.Ultrasonography will be performed by an experienced anesthetist.The 4th lumbar vertebral level will be determined using the conventional method (imaginary line between two iliac crests). The low frequency convex probe (2-5MHz) will then be placed at the mid-vertebral line in the sagittal plane. It will be shifted from the midline, 3.5-4 cm lateral to the side of the surgery to visualize the erector spinae muscle and transverse process. Using the out-plane technique a 22G/80-mm block needle will be advanced until it reaches the transverse process. After negative aspiration, 0.5-1 ml of the prepared local anaesthetic solution (20 ml bupivacaine 0.5%, 10 ml lidocaine 2%) and 10 ml normal saline will be administered for hydrodissection to confirm correct location. The needle will be repositioned by pulling back a few millimeters if resistance occurred when injecting local anesthesia
15731142|NCT05015517|Procedure|Fascia Iliaca block|"Patients will be placed in supine position. Ultrasonography will be performed by an experienced anesthetist using ultrasound device equipped with a low frequency (2-5 MHz) convex probe and an echogenic 21 G/ 10 cm needle will be used.
~The probe will be placed in the inguinal crease. Scan will be started laterally from the femoral artery and nerve in the inguinal crease to identify the Sartorius muscle. The muscle will then be traced until its origin at the anterior superior iliac spine is identified and the shadow of the bony of iliac crest & iliacus muscle will be seen. Injection will be performed at the plane deep to the fascia iliaca and above the lateral part of the iliacus muscle. After negative aspiration, the prepared local anaesthetic solution (15 ml bupivacaine 0.5%, 15 ml normal saline) will be injected incrementally, aspirating every 5 ml."
15731143|NCT05015504|Behavioral|Time restricted feeding|In Phase II the study subjects will be placed on time-restricted fasting (feeding between 4 AM - 4 PM, fasting in the rest of the day) for one week.
15731144|NCT05015491|Behavioral|Noom Healthy Weight Program|"The Healthy Weight program follows guidelines from the Obesity Society's 2013 Guidelines for the Management of Overweight and Obesity in Adults NIH Practical Guide on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults. Users are encouraged to log their weight (Weight Logging) at least 1x/week and log their food and beverages (Food Logging) daily. Exercise logging (steps via automatic collection or manually added) is done daily. The Noom Food color grading system is founded on calorie-density (Volumetrics diet, Barbara Rolls) and is a simple and effective method for creating long lasting changes in diet and food choice. Coaches are contacted via In-app messaging or phone communication."
15731145|NCT05015478|Device|Tailored Rhythmic Lighting Intervention|40 hertz (Hz) rhythmic lighting (RL) for a duration of 1 hour. The flicker frequency of the 40 Hz RL will be 40 Hz and the stimulation will be a square wave with a 50 % duty cycle (i.e., 12.5 milliseconds light- on and 12.5 milliseconds light-off). The RL will provide a 30 lux of red light on a vertical plane at the eye level.
15731146|NCT05015478|Device|Placebo Rhythmic Lighting Intervention|Placebo rhythmic light (RL) for a duration of 1 hour. In the placebo RL condition, the duty cycle will be delivered with a random interval determined by a Poisson process with an average interval of 40 hertz (Hz). The placebo RL conditions will provide a 30 lux of red light on a vertical plane at the eye level.
15731147|NCT05015465|Diagnostic Test|Anterior Segment OCT|AS-OCT for juvenile SLE patients and compare them with normal subjects
15731148|NCT05015452|Device|Transcatheter Aortic Valve Implantation|Interventional replacement of the aortic valve
15731149|NCT05015439|Drug|Cannabidiol|The study intervention will be supplied as a softgel capsule containing cannabidiol.
15731150|NCT05015439|Drug|Placebo|The study intervention will be supplied as a softgel capsule containing inert filler.
15731151|NCT05015426|Biological|Gamma Delta T-Cell Infusion|Donor cells will be processed in a laboratory, where T-cell subtype called γδ (gamma delta) T-cells will be isolated and expanded in number. These T-cells expanded in a laboratory will be infused in participants who are otherwise at high risk of AML recurrence after alloHCT.
15731152|NCT05015413|Device|Shockwave|Shock wave master 500 Germany
15731153|NCT05015400|Other|Plain Water|To increase water fluid intake, an additional 1.89 L, during phase 1 of the menstrual cycle (days 1-5).
15731154|NCT05015387|Procedure|Subgingival instrumentation|Under local anesthesia subgingival instrumentation with ultrasonic and hand instruments and magnification (4.5x) was performed.
15731155|NCT05015387|Combination Product|Subgingival application of collagen hydrogels with proanthocyanidins|Patients received collagen hydrogel chips with proanthocyanidins from Pelargonium sidoides root extract, placed subgingivally in periodontal pockets with PPD≥4mm after subgingival instrumentation.
15731156|NCT05015387|Diagnostic Test|Collection of saliva samples|For MMP-3/TIMP-1 detection, the collection of saliva samples was performed using Salivette (SARSTEDT AG and Co, Germany) saliva sample collection kit. Saliva samples were collected at the baseline for all patients and 6 weeks after treatment. Samples were centrifuged at 3500 rpm (2 min), aliquoted and protease inhibitors cocktail (1 mg/ml) was added to each sample. All samples were stored at -80oC. MMP-3, TIMP-1 concentration in saliva samples was examined using commercial ELISA kits (Elabscience, USA) and Multiskan Microplate Photometer (Thermo Fisher Scientific) at 450 nm wavelength. Saliva MMP-3/TIMP-1 samples were collected before treatment and 6 weeks after treatment.
15731157|NCT05015374|Dietary Supplement|Astaxanthin|350 mg/capsule (2mg Astaxanthin)
15731158|NCT05015374|Dietary Supplement|Placebo|Placebo
15731159|NCT05015361|Drug|Remimazolam Tosilate|Treatment group A: Remimazolam Tosilate; high dose Treatment group B: Remimazolam Tosilate; low dose
15731160|NCT05015361|Drug|Propofol Injection.|Treatment group C: Propofol Injection.
15731161|NCT05015348|Other|fish oil with omega-3 PUFA|3.6g per day fish oil with omega-3 PUFA (EPA+DHA)
15731162|NCT05015348|Other|placebo|palm oil as placebo
15731165|NCT05015322|Drug|bupivacaine and methylprednisolone|5 mL of 0.25% bupivacaine containing 20 mg methylprednisolone was administered to the subacromial area
15731166|NCT05015322|Drug|bupivacaine and methylprednisolone|5 mL of 0.25% bupivacaine containing 20 mg methylprednisolone was administered to the subacromial area for the subacromial+acromioclavicular joint injection. In addition, 2 mL of 20 mg methylprednisolone and the same concentration of local anaesthetic were injected into the acromioclavicular joint
15731167|NCT05015322|Drug|bupivacaine and methylprednisolone|suprascapular nerve block was administered with a mixture of 10 mL of 0.25% bupivacaine and 40 mg methylprednisolone
15731168|NCT05015309|Drug|SH3765 tablet|Starting dose 2.5mg, oral administered once daily. If tolerated subsequent cohorts will test increasing doses (5mg, 10mg, 15mg, 20mg, 25mg, 30mg) of SH3765.
15731169|NCT05015283|Procedure|The laparoscopic One-anastomosis gastric bypass will consist of:|gastrointestinal anastomosis: anterior colon and posterior stomach gastrointestinal anastomosis size: diameter < 1.5cm, linear anastomosis length 2.5cm biliary and pancreatic branches 200cm, food branches 100cm exact relationship with mesangial defect
15731170|NCT05015283|Procedure|The laparoscopic Roux-en-Y gastric bypass will consist of:|the laparoscopic Roux-en-Y gastric bypass gastric sac size < 30ml gastrointestinal anastomosis: anterior colon and posterior stomach gastrointestinal anastomosis size: diameter < 1.5cm, linear anastomosis length 2.5cm biliary and pancreatic branches 50cm, food branches 150cm exact relationship with mesangial defect
15731171|NCT05015270|Diagnostic Test|Medications or percutaneous coronary intervention|In this study, we will for the first analyze the correlation of proteins concentration with coronary artery disease burden. Next, the prediction of proteins for one-year clinical events will be further analyzed
15731172|NCT05015257|Dietary Supplement|Standard F100|100 kcal and 3 g protein per 100 ml
15731173|NCT05015257|Dietary Supplement|Standard F75 + Plumpynut|Standard F75 with ready to-use therapeutic food (Plumpynut)
15731174|NCT05015257|Dietary Supplement|Alternative F75 with CMV + Plumpynut|Alternative F75 containing CMV with ready to-use therapeutic food (Plumpynut)
15731175|NCT05015257|Dietary Supplement|Alternative F75 without CMV + Plumpynut|Alternative F75 with no CMV with ready to-use therapeutic food (Plumpynut)
15731176|NCT05015244|Procedure|3T (Tesla) Magnetic Resonance Imaging (MRI)|Neurological evaluation using MRI and neuropsychological tests
15731177|NCT05015231|Diagnostic Test|Echocardiography and MRI|Echocardiography and renal MRI before and after fistula closure
15731178|NCT05015218|Diagnostic Test|Vacular Ultrasound|To visualize the right internal jugular vein ( RIJV) a linear transducer with a 5-10 MHz linear probe was placed over the neck, and the IJV was measured just below the bifurcation of the sternal and clavicular heads of the muscle. The IJV measurements were performed on the transverse axis over a single respiratory cycle. Patients with evidence of IJV thrombosis were excluded. RIJV measurements included the antero-posterior maximum diameter at the end of expiration (RIJVmax), the antero-posterior mimimum diameter at the end of inspiration (RIJVmin), the RIJV collapsibility index (RIJV-CI) during spontaneous, quiet, breathing, [(RIJVmax - RIJVmin diameter)/RIJVmax] and the ratio (R) of RIJVmax-to-RIJV-CI.
15731179|NCT05015205|Other|Muscle Energy Technique|Post isometric relaxation technique MET was applied in two muscle groups; Lumbar Extensors (Erector Spinae) and Hip Flexors (Iliopsoas). The muscle was positioned in position and patient was asked to apply 20% force isometrically and hold the isometric contractions for 7-10 seconds. Then the patient was asked to relax for about seconds. On exhalation, therapist takes muscle to new restriction barrier. Hold this position for 30 seconds at the end barrier as an end-stretch with 3 repetitions.
15731180|NCT05015205|Other|Postural Correction Exercises|: Postural Correction Exercises was applied to one group. Exercises performed included stretching and strengthening exercises. Hip flexors and back extensors were stretched while hip extensors and abdominals were strengthened. Seated hip flexion used to stretch back extensors while lunge position used to stretch hip flexors. The abdominals were strengthened by using curl up exercises while hip extensors were strengthened by resisted contractions in prone lying.
15731181|NCT05015192|Drug|NH102|tablets, orally
15731182|NCT05015192|Drug|Placebo|tablets, orally
15731183|NCT05015179|Procedure|mixed reality technology in laparoscopic partial nephrectomy|All patients undergo contrast-enhanced computed tomography before surgery. DICOM files are converted to a 3D model. This model is then sent to HoloLens 2 smart glasses using HLOIA software
15731184|NCT05015166|Behavioral|Experimental: Internet delivered self-help program with therapist support|During 8 weeks of treatment participants are taught how emotional conflicts may underlie and perpetuate symptoms of social anxiety. They are also taught how to observe their own anxiety and emotional avoidance (i.e. defenses) and how to gradually approach previously warded off feelings. The final part of the program contains material on how one may express previously warded off emotions to improve important relationships. The treatment program consists of text, videos and a series of experiential exercises which a therapist gives feedback on.
15731185|NCT05015166|Behavioral|Internet delivered self-help program without therapist support|During 8 weeks of treatment participants are taught how emotional conflicts may underlie and perpetuate symptoms of social anxiety. They are also taught how to observe their own anxiety and emotional avoidance (i.e. defenses) and how to gradually approach previously warded off feelings. The final part of the program contains material on how one may express previously warded off emotions to improve important relationships. The treatment program consists of text, videos and a series of experiential exercises.
15731186|NCT05015153|Other|Pulmonary rehabilitation (PR)|20 sessions of PR in respiratory rehabilitation centre will be performed over a period of 3 months
15731187|NCT05015140|Other|musıc therapy|calm music with nature sounds set by the music therapist
15731188|NCT05015127|Drug|HBM9161 680 mg qw|HBM9161 680 mg qw
15731189|NCT05015127|Drug|Placebo|Placebo
15731190|NCT05015127|Drug|HBM9161 680 mg qw by q2w|HBM9161 680 mg qw by q2w
15731191|NCT05015114|Other|Sarcopenia Assessment|Sarcopenia Assessment
15731192|NCT05015101|Other|Cohort observation|Cohort observation
15731193|NCT05015088|Other|No interventions will be performed in this study|This study will not include any intervention
15731194|NCT05015075|Behavioral|cardiac rehabilitation|cardiac rehabilitation after pacemaker implantation
15731195|NCT05015062|Behavioral|Mobile-based HIV-related educational message delivery|HIV/AIDS awareness-raising and behavior-related cyclic messages will be delivered by the village doctors on a biweekly basis for 18 months.
15731915|NCT05009381|Device|Stylage XXL at Month 6|Injection in the chin 6 months after randomization
15731196|NCT05015062|Behavioral|Incentive policies evaluation|village doctors in Intervention A and B will receive different types of monetary compensation. Doctors in Intervention A will receive standardized compensation for completing their assigned tasks. Doctors in Intervention B will receive performance-based compensation whose amount depends on how well the participants perform on the follow-up questionnaires.
15731197|NCT05015036|Procedure|ERAS|Minimally invasive surgery of the lumbar spine with Enhanced Recovery After Surgery (ERAS)
15731198|NCT05015036|Procedure|Minimally invasive surgery|Classic Minimally invasive surgery of the lumbar spine
15731199|NCT05015023|Behavioral|Behavioral intervention|A cluster-randomized controlled trial will be conducted.
15731200|NCT05015010|Drug|Alectinib|600 mg p.o. (four 150 mg capsules) twice daily with food (within 30 minutes after a meal, in the morning and evening).
15731201|NCT05014997|Other|no intervention|this study was designed as retrospective observational study
15731202|NCT05014984|Behavioral|mental contrasting with implementation intentions|"To deliver MCII, Dr. Oettingen developed a step-wise procedure called WOOP (Wish, Outcome, Obstacle, Plan; Figure 1).36 In a quiet setting, patients identify an important wish (e.g., losing weight) and then name and vividly imagine the best outcome (e.g., feeling healthier). Next, they name a current internal obstacle (e.g., urge to eat when feeling stressed) and try to vividly imagine their experience when they encounter this obstacle. Finally, they address their obstacle with an if-then plan specifying when, where, and how to overcome it (e.g., If I have the urge to eat when feeling stressed, I will go for a walk) and then imagine themselves experiencing the obstacle and carrying out the action of surmounting it. To facilitate use of the WOOP technique, Dr. Oettingen developed a free, publicly available WOOP app"
15731203|NCT05014984|Behavioral|telephone-delivered MOVE!|MOVE! is a national VA weight management and health promotion program to improve the quality of life of Veterans.6,75 This effective program encourages healthy eating behavior and increased physical activity. MOVE! will be delivered via telephone (16 sessions) by existing staff consistent with national MOVE! program guidelines. The program has 16 modules and will offered weekly, but Veterans will be able to make up sessions at their own pace if they miss one. MOVE! staff use the MOVE! facilitator guide that provides instruction on delivering the program via telephone.
15731204|NCT05014984|Behavioral|Information About Diet, Physical Activity, and Weight Management (Baseline Visit - 10 minutes): All|All participants will receive handouts that they review with a lay educator on weight management, adapted from the educational materials developed for our FIReWoRk Study.Topics include losing weight at a healthy rate, setting a 6-month weight loss goal of 5-10%, limiting sugar-sweetened beverages and portion sizes, making better choices when eating at restaurants, self-monitoring diet and weight, and participating in at least moderate-intensity physical activities.
15731205|NCT05014984|Behavioral|Telephone MCII Check-ins (30 minutes at 3 days, 4 weeks, and 2 months after baseline visit)|The lay educator will review and practice the WOOP technique based on protocols from prior studies.12 To probe Veterans' comprehension, the lay educator will ask for their four steps and ask about their WOOP use and experiences. If needed, the lay educator will help the Veteran to create a new WOOP for the next month and address any questions and concerns about using WOOP.
15731206|NCT05014971|Behavioral|Tele-neurohub|Interdisciplinary care delivered using telemedicine (zoom) technology which includes neurologist, physical, occupational and speech therapy, social worker and dietician.
15731207|NCT05014958|Other|Exercise training on whole body vibration|Participants will be included in the 6-week exercise training on whole body vibration
15731208|NCT05014945|Procedure|(atelocollagen group)|Epidural nerve block and atelocollagen injection into the multifidus muscle were performed sequentially. The target level is determined by the clinician by combining the pre-MRI and the patient's symptoms. All procedures are performed under the guidance of fluroscopy. For epidural nerve block, use 10cc of 0.9% normal saline mixed with 3000IU of hyaluronidase to be injected. After the epidural nerve block, a solution of 1 mL of atelocollagen mixed with 1 mL of 1% lidocaine is injected into the multifidus muscle to complete the entire procedure.
15731211|NCT05014906|Drug|Minocycline 45 MG|45 mg oral minocyclineonce daily vs 45mg oral minocycline once daily in combination with use of 15% azelaic acid
15731212|NCT05014906|Drug|Azelaic acid|45 mg oral minocyclineonce daily vs 45mg oral minocycline once daily in combination with use of 15% azelaic acid
15731213|NCT05014893|Combination Product|multi-modal targeted intervention (e.g., cognitive training, exercise, games)|The Intervention group will be given recommended interventions tailored to individuals based on their risks (e.g., physical exercise programs, cognitive training, dietary advice, control of blood pressure and cholesterol, healthy diet, control obesity, stop smoking,reduce alcohol excess)
15731214|NCT05014880|Behavioral|ICR (Intensive Cardiac Rehabilitation)|Participants in this arm will not have to adopt a 10-hour eating window while taking part in UCSD's 9-week ICR program.
15731215|NCT05014880|Behavioral|ICR x TRE (Intensive Cardiac Rehabilitation x Time-Restricted Eating)|Participants in this arm will adhere to a daily, consistent 10-hour eating window while undergoing UCSD's 9-week ICR program to see if there is an improvement on cardiometabolic parameters.
15731216|NCT05014867|Procedure|Embryo transfer method|"Sequential embryo transfer on day 3 and day 5 in a frozen cycle
~Sequential embryo transfer on day 3 and day 5 in a fresh cycle
~Sequential embryo transfer on day 3 and day 5 after performing PGS
~Conventional Day 5 frozen embryo transfer"
15731217|NCT05014854|Device|Usage of the SensoGrip-System comprised of the SensoGrip pen and a tablet app.|Intervention consists of the usage of the SensoGrip-System in at least 6 and up to 8 therapy session together with the participating child. It is assumed that the standard frequency of therapy sessions is once a week, resuming in a span of 6-8 weeks. 10 minutes of every therapy session during the intervention phase must involve the application of the SensoGrip-System. Sample exercises are made available, therapists can freely choose which exercises are used.
15731218|NCT05014841|Behavioral|Speech Tasks|Listen to 20-minutes of speech sounds in English, Spanish, and/or Mandarin.
15731219|NCT05014828|Drug|lenvatinib|Capsules administered orally
15731220|NCT05014828|Drug|Tislelizumab|intravenous (iv) infusion
15731225|NCT05014789|Device|Control-IQ technology 2.0|All subjects wearing the t:slim X2 insulin pump with Control-IQ technology 2.0, and wearing the Dexcom G6 sensor
15731226|NCT05014776|Drug|Tadalafil|Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Tadalafil (20 mg) will be administered orally every day on days 3-21 for cycles 1-6.
15731227|NCT05014776|Drug|Pembrolizumab|Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Pembrolizumab (200 mg) will be administered IV on Day 1 of cycles 1-6.
15731228|NCT05014776|Drug|Ipilimumab|Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (50mg) will be administered IV on Day 1 of Cycles 1, 3, and 5.
15731229|NCT05014776|Drug|CRS-207|Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 [1 × 109 colony forming units (CFU) in 100ml NS] will be administered IV on Day 2 of Cycles 1-6.
15731230|NCT05014763|Procedure|connective tissue graft|Connective tissue graft surgery will be done for increasing soft tissue volume. In this methods connective tissue will be harvested from lateral palate or tuberosity area.
15731231|NCT05014750|Other|None intervention|There is no intervention included in this study.
15731232|NCT05014737|Other|no intervention|this is an abservational study and no intervention will be involved
15731233|NCT05014724|Drug|Rozanolixizumab|Rozanolixizumab is dosed weekly at 10 mg/kg. Patients should continue to receive the dose they were receiving in the CIDP04 (NCT04051944) trial.
15731234|NCT05014711|Drug|Remifentanil|Before infusion, remifentanil is given 0.3 g/kg slowly intravenous injection more than 60 seconds, and the initial dose is 0.025ug/kg/min. The dosage is adjusted to achieve the target depth of analgesia and sedation (CPOT < 3, RASS -2 to 1), with each change 0.025ug/kg/min and the maximum dose 0.15ug/kg/min.
15731235|NCT05014711|Drug|Fentanyl|Before infusion, fentanyl is given 0.3 g/kg slowly intravenous injection more than 60 seconds, and the initial dose is 0.025ug/kg/min. The dosage is adjusted to achieve the target depth of analgesia and sedation (CPOT < 3, RASS -2 to 1), with each change 0.025ug/kg/min and the maximum dose 0.15ug/kg/min.
15731236|NCT05014698|Genetic|WGS|Whole Genome sequencing
15731237|NCT05014685|Drug|Rabeprazole|20mg bid
15731238|NCT05014685|Drug|Bismuth potassium citrate|0.6g bid
15731239|NCT05014685|Drug|Metronidazole|0.4g tid
15731240|NCT05014685|Drug|Amoxicillin|1g tid
15731243|NCT05014659|Dietary Supplement|Creatine monohydrate|4 x 5g doses daily for 5 days, followed by 1 x 5g dose daily for 23 days.
15731244|NCT05014659|Dietary Supplement|Placebo|4 x 5g doses daily for 5 days, followed by 1 x 5g dose daily for 23 days.
15731245|NCT05014646|Drug|Cholestyramine|Given PO
15731246|NCT05014646|Drug|Leflunomide|Given PO
15731247|NCT05014633|Other|EI skills training|EI training sessions were held and managed by two experienced instructors selected from medical education specialists with sufficient experience in conducting EI training. Both instructors attended the sessions, presented the content, videos, slides, and brochures with the help of each other, and managed related scenarios in each session.
15731248|NCT05014620|Other|Semi-directive interview|semi-structured exploratory interview
15731249|NCT05014607|Biological|Personalized multi-peptide vaccine|"Peptide vaccine: Personalized multi-peptide vaccine cocktails consisting of 200-300µg each of 5-10 tumor-associated peptides selected individually based on the patient-individual HLA allotypes and HLA ligandome analysis of tumor cells Peptides are synthesized in the GMP-certified Wirkstoffpeptidlabor at the University of Tübingen and will be formulated at the GMP-Center of the University Hospital Tübingen.
~Peptides will be administered subcutaneously (s.c.) together with the TLR1/2 ligand XS15 emulsified in Montanide ISA 51 VG as adjuvant.
~Vaccination will take place every 6 weeks. A total of two to five vaccinations are planned.
~Treatment schedule:
~Vaccination will take place every 6 weeks. A total of two to five vaccinations are planned, depended on the induction of peptide-specific T-cell responses."
15731250|NCT05014594|Drug|Dapagliflozin (10Mg Tab) along with standard medical therapy|Oral Dapaglifozin (10 mg/day) along with standard medical therapy will be given to Group A while a placebo of dapaglifozin along with standard medical therapy will be used in Group B
15731251|NCT05014594|Drug|Placebo of dapaglifozin along with standard medical therapy|Standard medical therapy will include dietary restriction of sodium, treatment with diuretics, repeated LVP as needed and other supportive care. Patients on non-selective beta blockers will continue to do so with dose modifications/withdrawal as per Baveno VI guidelines.
15731252|NCT05014581|Drug|Noradrenaline|Pre-emptive continuous infusion of noradrenaline during the peri-intubation period
15731253|NCT05014568|Drug|tapinarof cream, 1%|applied topically once daily
15731254|NCT05014568|Drug|Vehicle cream|applied topically once daily
15731255|NCT05014555|Biological|COVID-19 Vaccine|Two-dose mRNA COVID-19 vaccine per standard of care
15731256|NCT05014542|Procedure|Acupuncture|Acupuncture treatment includes pricking the skin with acupuncture needles 0.3 x 40 millimetres in size, in the places of prescribed acupuncture points. Placed needles should be manipulated three times, every ten minutes, three times in total. The complete time of treatment is 30 minutes. All treatments will be equal.
15731257|NCT05014542|Drug|Conventional Medical Treatment|Participants could take their standard conventional medical treatment or analgesics. Analgesics therapy is prescribed by their general practitioner. The dose of analgesics could be modified according to participants' symptoms intensity.
15731258|NCT05014516|Drug|129Xenon gas|Observational
15731291|NCT05014269|Procedure|Phacoemulsification in eyes with corneal opacities|senile cataract extraction using lens emulsification under the slit illuimnation of the surgical microscope
15731292|NCT05014256|Behavioral|STEPS Health System Outreach intervention|STEPS Transplant Social Worker Education and Outreach, STEPS Transplant Coordinator Outreach
15731293|NCT05014230|Dietary Supplement|Open Placebo|Zeebo
15731294|NCT05014230|Other|Opioid medication as part of standard care|Opioid medication as prescribed by prescriber. This is not impacted by being in the research study.
15731840|NCT05009784|Other|Medium Traffic and Bird Sound|Experimental: Medium Traffic and Bird Sound (Played through speakers)
15731841|NCT05009784|Other|Long Traffic and Bird Sound|Experimental: Long Traffic and Bird Sound (Played through speakers)
15731259|NCT05014503|Other|Adaptive Therapeutic gaming|All children will be asked to use the adaptive version of the therapeutic game for three months, during their free time, at home or at the special school where they stay. They will be asked to play the game minimally three times per week between 20-30 minutes per session. The researchers will install the game on a device of choice for the children. Back-up devices are available from the study team to ensure that children having no suitable device can participate in the study. The parent and/or caretaker will be asked to support the child in starting the program, but not to intervene during the actual game time. The game is designed to ensure that children can play independently. Therefore, children will be able to play at home, at school or during their free time. The program will not replace their regular therapy program, but will be provided additionally. The number of regular therapy hours will however be registered.
15731260|NCT05014503|Other|Non-adaptive Therapeutic gaming|All children will be asked to use the non-adaptive version of the therapeutic game for three months, during their free time, at home or at the special school where they stay. They will be asked to play the game minimally three times per week between 20-30 minutes per session. The researchers will install the game on a device of choice for the children. Back-up devices are available from the study team to ensure that children having no suitable device can participate in the study. The parent and/or caretaker will be asked to support the child in starting the program, but not to intervene during the actual game time. The game is designed to ensure that children can play independently. Therefore, children will be able to play at home, at school or during their free time. The program will not replace their regular therapy program, but will be provided additionally. The number of regular therapy hours will however be registered.
15731261|NCT05014490|Drug|Exib 120 mg etoricoxib film-coated tablets|Oral, COX-2 highly selective, non-steroidal anti-inflammatory generic drug
15731262|NCT05014490|Drug|Arcoxia® 120 mg etoricoxib film-coated tablets|Oral, COX-2 highly selective, non-steroidal anti-inflammatory innovative drug
15731263|NCT05014477|Procedure|Removal or leaving of LAA occluders|After LAA device embolization there are different approaches to dealing with the occluder dislocation. The aim is to find out which way leads to the best outcomes.
15731264|NCT05014464|Drug|Crizotinib|Crizotinib 250mg po bid
15731265|NCT05014438|Drug|BMS-986166|Specified dose on specified days
15731266|NCT05014438|Drug|Branebrutinib|Specified dose on specified days
15731267|NCT05014438|Other|Placebo|Specified dose on specified days
15731268|NCT05014425|Procedure|pancreaticoduodenectomy|
15731270|NCT05014386|Procedure|Ahmed Glaucoma Valve Implantation in secondary pediatric glaucomas.|A 7-0 silk traction suture was placed through the clear cornea.A conjunctival incision was made 4 mm posterior to the limbus in the supratemporal quadrant. After dissecting conjunctiva and Tenon's primed FP7 or FP8 AGV was inserted into the subconjunctival space and sutured to sclera using two interrupted 7-0 silk sutures 8-10 mm posterior to the limbus. A 23-gauge needle was used to enter the anterior chamber from the surgical limbus. The tube then was cut beveled up and inserted into the anterior chamber through the tunnel. Finally, conjunctiva and Tenon were approximated using a running 8-0 Vicryl suture.At the close of surgery, subtenon antibiotic and steroids were injected in all cases.
15731271|NCT05014386|Procedure|Ahmed Glaucoma Valve Implantation with Ologen augmentation in secondary pediatric glaucomas|A 7-0 silk traction suture was placed through the clear cornea.A conjunctival incision was made 4 mm posterior to the limbus in the supratemporal quadrant. After dissecting conjunctiva and Tenon's primed FP7 or FP8 AGV was inserted into the subconjunctival space and sutured to sclera using two interrupted 7-0 silk sutures 8-10 mm posterior to the limbus. A 23-gauge needle was used to enter the anterior chamber from the surgical limbus. The tube then was cut beveled up and inserted into the anterior chamber through the tunnel. a round 12 × 1 mm circular Ologen disc will be placed over the FP7 or FP8 AGV-plate immediately before conjunctival closure. Finally, conjunctiva and Tenon were approximated using a running 8-0 Vicryl suture.At the close of surgery, subtenon antibiotic and steroids were injected in all cases.
15731272|NCT05014373|Combination Product|Favipiravir + Standard of Care|"1800 mg twice daily for one day, followed by 800mg (4 tablets) twice daily
~Plus Standard of Care"
15731273|NCT05014373|Procedure|Standard of Care|Best supportive care includes Standard treatment included oral or intravenous rehydration, electrolyte correction, antipyretics, analgesics, antibiotics and antiemetic drugs & the medication any patient is on due to any concomitant diseases.
15731274|NCT05014360|Drug|JNJ-64251330|JNJ-64251330 tablets will be administered orally.
15731275|NCT05014334|Drug|Berberine|berberine 500 mg, twice daily for 14 days
15731276|NCT05014334|Drug|Vonoprazan|Vonoprazan 20 mg, twice daily for 14 days
15731277|NCT05014334|Drug|Amoxicillin|amoxicillin 1000mg, twice daily for 14 days.
15731278|NCT05014334|Drug|Rabeprazole|Rabeprazole 10mg, twice daily for 14 days.
15731279|NCT05014334|Drug|Bismuth|Bismuth 220mg, twice daily for 14 days.
15731280|NCT05014334|Drug|Clarithromycin|clarithromy 500mg, twice daily for 14 days.
15731281|NCT05014321|Device|EC16 medical device (CE marked)|Application on brown spots located on the face (1 treatment during the study).
15731282|NCT05014321|Device|device prototype (810A-v1)|Application on brown spots located on the face (4 treatments during the study).
15731283|NCT05014321|Device|device prototype (810B-v1)|Application on brown spots located on the face (4 treatments during the study).
15731284|NCT05014321|Device|device prototype (810C-v1)|Application on brown spots located on the face (4 treatments during the study).
15731285|NCT05014308|Procedure|Piezoelectric Alveolar Decortication, fibrotomy|
15731286|NCT05014295|Other|Accessing personal medical records online via online portals|The participants will receive details on accessing personal medical records online via online portals, for each of the major hospital systems
15731842|NCT05009784|Other|Short Traffic and Water Sound|Experimental: Short Traffic and Water Sound (Played through speakers)
15731295|NCT05014217|Behavioral|Mentalization-based Treatment|An empirically-validated intervention for personality disorders based on the attachment theory and on knowledge from developmental psychology and cognitive neuroscience (Bateman and Fonagy, 2004). Patients assist psychoeducative group meetings beforehand, along with a pretreatment of four to six individual meetings (over four to eight weeks), followed by bi-weekly individual follow-ups and weekly group follow-ups. The treatment lasts two years. Patients have an assessment meeting with their individual therapist and one of the group therapists at the end of each session. Psychiatric follow-up appointments are on an as-needed basis and every patient has a treatment contract with specific and measurable treatment objectives.
15731296|NCT05014217|Behavioral|Dialectical Behavior Therapy-inspired Treatment|A psychotherapy developed by M. Linehan for patients with borderline personality disorder that combines cognitive behavioral therapy techniques (emotional regulation, practical exercises) with Buddhist meditation principles (stress tolerance, acceptance, open-mindedness) (Linehan, M. M. & Dimeff, L., 2001). As opposed to Linehan's model, individual meetings are bi-weekly, no emergency phone service is offered, the mindful meditation module is reorganized into life habits modules, and every module includes mindfulness exercises. Patients assist psychoeducative group meetings beforehand, along with a pre-treatment of 4-6 individual meetings (over 4-8 weeks), followed by bi-weekly individual follow-ups and weekly group follow-ups. The treatment lasts one year, but can be extended to two years for eligible patients who are interested. Psychiatric follow-up appointments are on an as-needed basis. Every every patient has a treatment contract with specific and measurable treatment objectives.
15731297|NCT05014178|Diagnostic Test|Sodium-23 MRI|Participants will lay in the MRI bed for approximately 60 minutes during scanning while the MRI technologist takes detailed pictures of their kidneys.
15731298|NCT05014165|Other|Cord blood Sample Collection|Obtain banked cord blood samples from consecutive childhood leukemia patients
15731299|NCT05014165|Other|Case identification and recruitment|Cases meeting eligibility and who have given consent through APEC14B1 for future contact for non-therapeutic studies
15731300|NCT05014165|Other|Questionnaire Administration|The family will be given an option to complete questionnaire on paper, online, or over the telephone.
15731301|NCT05014152|Device|Q-temp-w1|Q-temp-w1 is a contact type body temperature patch developed by Quanta Computer Co., Ltd. It is mainly used to measure the body temperature of the human body. It can be used for general body temperature measurement, home temperature measurement records and medical tracking.
15731302|NCT05014152|Device|Omron thermometer(MC-171W)|Omron thermometer(MC-171W) is mainly used to measure the body temperature of the human body. The reference temperature patch used in this study is the OMRON thermometer, model: MC-171W.
15731303|NCT05014139|Drug|Enfortumab vedotin|Given into the bladder (intravescially)
15731304|NCT05014126|Behavioral|Pain, Stress and Emotions|2-hour, zoom-delivered, group intervention focused on teaching patients how pain is processed in their brain and learning about the role of psychosocial factors in their pain conditions.
15731305|NCT05014113|Device|DELTA-ST cup in combination with MINIMA stem|Advance articular destruction generated by primary degenerative or post-traumatic arthrosis or reumatoid arthritis; fracture or avascular necrosis; congenital or acquired deformity.
15731306|NCT05014100|Drug|Orelabrutinib tablet|Subjects received orelabrutinib150mg orally once daily for a 28-day cycle. Throughout the study period, all subjects continued treatment until one of the following conditions occurred: disease progression, intolerable toxicity, death, withdrawal of informed consent, or loss of follow-up
15731307|NCT05014100|Drug|Lenalidomide|"Lenalidomide 25mg once daily for 21 days and rituximab 375mg/m2 for 7 days
~Throughout the study period, all subjects continued treatment until one of the following conditions occurred: disease progression, intolerable toxicity, death, withdrawal of informed consent, or loss of follow-up"
15731308|NCT05014087|Drug|Intravenous digoxin|"Loading dose: the total loading dose of digoxin will be determined using the Loading nomogram. The FDA-recommended total IV digoxin loading dose range is 8 to 12 mcg/kg. The lowest recommended dose of 8 mcg/kg was used in constructing the digoxin Loading nomogram that will be used in this trial.
~Maintenance dose: the maintenance dose will be started approximately 24 hours after initiation of digoxin loading. The post-loading digoxin trough will be reviewed prior to starting maintenance dosing.
~Subjects on P-gp inhibitors or spironolactone, will have an additional digoxin level performed 12-hours after any dose adjustment. Once digoxin levels are stable, 24-hour blood draws will be performed."
15731309|NCT05014074|Other|Theater/Pilot Testing|Participants will take part in a theater/pilot testing in order to receive adequate feedback and make substantive change in the intervention
15731310|NCT05014061|Drug|Adenosine|Adenosine infusion 70 µg/kg/min for 6 hours
15731311|NCT05014048|Dietary Supplement|Vitamin D3|20 mikrog vitamin D3 daily
15731312|NCT05014048|Dietary Supplement|Placebo|Placebo
15731313|NCT05014035|Behavioral|Resistance Exercise|This is an 8-week exercise program, delivered using a hybrid approach of in-person, in-home supervised exercise, and virtual delivery of exercise via zoom. Individuals will participate in resistance exercise 3 days per week for 8 weeks.
15731314|NCT05014022|Diagnostic Test|Multiparametric renal MRI|10 patients in the cohort will undergo MRI scanning at day 30 and 90
15731315|NCT05014009|Behavioral|FIFA11+ and multidirectional training (MD)|"This intervention initially contains a shortened version of the FIFA11+ injury prevention program including running (straight, hip out, hip in, jump-run-ups), strengthening (planks, squats, nordic hamstring curls), and single-leg balance exercises. The initial part is followed by COD technique modification training, which contains exercises aimed at improving COD technique (safer and more effective body re-direction, use of penultimate step, avoiding knee valgus) and COD braking and re-acceleration impulse.
~The duration of each training session is 25-30 minutes. The training is carried out twice per week under supervision with supervisors providing feedback to participants regarding their COD technique. Participants are encouraged to complete a third training session in their own time."
15731345|NCT05013775|Diagnostic Test|Computed tomography|Computed tomography to gauge response after preoperative chemotherapy cycles and excluded the development of interval metastases or irresectable disease
15731346|NCT05013775|Diagnostic Test|Diagnostic laparoscopy with peritoneal lavage|Diagnostic laparoscopy lavage to exclude (small-volume) metastases and determine local resectability
15731843|NCT05009784|Other|Medium Traffic and Water Sound|Experimental: Medium Traffic and Water Sound (Played through speakers)
15731949|NCT05009082|Drug|Paclitaxel|175 mg/m², intravenous, on day 1 every 3 weeks for 6 cycles
15731316|NCT05014009|Behavioral|FIFA11+ and linear sprint training (MD)|"This intervention initially contains a shortened version of the FIFA11+ injury prevention program including running (straight, hip out, hip in, jump-run-ups), strengthening (planks, squats, nordic hamstring curls), and single-leg balance exercises. The initial part is followed by a linear sprint training, which contains exercises aimed at improving sprint technique (e.g. sagittal arm and leg movement, trunk lean), use of the stretch-shortening cycle, leg stiffness and propulsive impulse .
~The duration of each training session is 25-30 minutes. The training is carried out twice per week under supervision with supervisors providing feedback to participants regarding their sprinting technique. Participants are encouraged to complete a third training session in their own time."
15731317|NCT05013996|Behavioral|MIDSA|Multidimensional Inventory of Development, Sex, and Aggression
15731318|NCT05013996|Behavioral|Usual methods of evaluation|Usual methods of evaluation of each of the participating centers (CMP / CRIAVS / private practitioners, etc.).
15731319|NCT05013983|Biological|Recombinant COVID-19 vaccine (Sf9 cells)|This vaccine is made by using baculovirus as a vector and expressing SARS-CoV-2 S-RBD in Sf9 cells, which is purified
15731320|NCT05013983|Other|Placebo control|Except for the absence of study vaccine antigen, all other components (aluminum hydroxide, sodium chloride, sodium
15731321|NCT05013970|Other|Clinical assessment|Clinical assessment including Visual Analog Scale (VAS) for Knee Pain, and Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
15731322|NCT05013970|Other|Radiographic imaging|MRI of the knee
15731323|NCT05013957|Diagnostic Test|Methylation analysis|Methylation analysis
15731324|NCT05013918|Other|Observational study|No intervention
15731325|NCT05013905|Drug|PRA023 IV|PRA023 administered at timepoints as directed by the protocol
15731326|NCT05013905|Device|Companion diagnostic (CDx)|CDx+ or CDx-
15731327|NCT05013892|Radiation|NTS-WBRT (normal tissue sparing whole brain radiation therapy)|Radiation
15731328|NCT05013892|Radiation|HA-WBRT (hippocampal avoidance whole brain radiation therapy)|Radiation
15731329|NCT05013892|Drug|Memantine|Capsule, taken orally
15731331|NCT05013866|Procedure|Repair resin composite proximal|Repair proximal composite resin restoration, removing the defective material and then restoring it with another composite resin
15731332|NCT05013853|Procedure|Restoration teeth|Remove caries and restore with resin composite
15731333|NCT05013840|Behavioral|Filling in an online survey|Physicians are asked to fill in an online survey regarding 1) goals to treat patients with neuromodulation for pain, 2) factors that respondents expect to change according to neuromodulation for pain and 3) their definition of success of neuromodulation for pain.
15731334|NCT05013827|Behavioral|Filling in an online survey|Company representatives are questioned about three aspects: 1) goals in treating patients with neuromodulation for pain, 2) factors that respondents expect to change according to neuromodulation for pain and 3) their definition of success of neuromodulation for pain.
15731335|NCT05013814|Diagnostic Test|Semmes-Weinstein monofilament test|Tactile function was evaluated mainly as tactile registration by using 20-item Semmes-Weinstein monofilament (SWM) kit. The monofilament was applied three times with a pseudorandom order to distal pad of the thumb, index, 4th and 5th digits (C6, C7 and C8 dermatomes). The lowest value of monofilament was recorded which the child was able to correctly identify at least one touch out of three
15731336|NCT05013814|Diagnostic Test|Box and Block Test|Box and Block Test (BBT) was used for dexterity assessment. The BBT measures unilateral gross manual dexterity. The child was asked to move, one by one, the maximum number of blocks from one compartment of a box to another of equal size within 60 seconds
15731337|NCT05013814|Diagnostic Test|9-Hole Peg Test|9-Hole Peg Test (9-HPT) is used to measure finger dexterity. Firstly, the child takes the pegs from a container, one by one, and place them in the holes on the board; then participant removes the pegs from the holes and replaces them back into the container. The total time taken to complete the test is recorded in seconds.
15731338|NCT05013814|Diagnostic Test|Duruöz Hand Index (DHI)|Duruöz Hand Index (DHI) is an 18-item self-report questionnaire regarding ability to carry out manual tasks. Individual items are scored on a 6-point Likert scale where 0=without difficulty and 5=impossible. The total score ranges from 0-90 with higher scores indicating poorer hand function.
15731339|NCT05013814|Diagnostic Test|Jamar hand dynamometer|Hand grip strength was measured by using Jamar hydraulic hand dynamometer. Measurement was done with the participant in sitting position and the elbow at 90 degrees of flexion. The force has most commonly been measured in kilograms according to the amount of static force that the hand can squeeze around the dynamometer.
15731340|NCT05013814|Diagnostic Test|Hydraulic pinch gauge|Hydraulic pinch gauge is used for evaluation of finger grip strength. The evaluation method was the same as Jamar hand dynamometer.
15731341|NCT05013801|Other|Cosmetic facial serum Q69|Cosmetic facial serum
15731342|NCT05013801|Drug|2% Hydroquinone|2% Hydroquinone cream
15731343|NCT05013788|Other|Social Media Enhanced Education|Along with usual asthma education received,participants will receive asthma education via various social media platforms ,Facebook, Twitter, Instagram, and/or Snapchat. Topics of education will include background on asthma and pathophysiology, asthma severity classification, asthma triggers, different medications and indications for when to take them, how to use an inhaler technique, and symptom monitoring.Online resources from the American Lung Association and the National Asthma Education and Prevention Program will also be posted.
15731344|NCT05013788|Other|Usual Asthma Education|For patients who are admitted to Children's Memorial Hermann for asthma exacerbation, asthma education is provided to patients and families on the day of discharge by the nurse and respiratory therapist on triggers, Signs & Symptoms, Medication Use, Medication Delivery, Peak Flow, Zones and how to respond to each, and Cleaning equipment.Nursing staff are responsible for printing out education sheets to give to patients and showing an education video that is 20 minutes long. An asthma action plan are given to families on discharge. Patients that are discharged from the emergency room are given the same educational materials by the nurses and/or respiratory therapists except for the asthma video. Patients receive a variable amount of asthma education when going to usual clinic visits. The education provided is dependent on the provider, and usually limited in length to the time of the visit
15731347|NCT05013762|Behavioral|Fast intervention|This intervention is based on recent body of evidence that high-speed movements during training are effective at improving arm movements in individuals with chronic stroke.Participants will be rewarded for movements performed within a short amount of time.
15731348|NCT05013762|Behavioral|Active Monitoring|This is an observation-only group. The training received in this group will be dose equivalent to the active group.
15731349|NCT05013749|Procedure|Hysterectomy|Hysterectomy: An incision will be made above the level of the placenta, delivering the newborn. Uterotonics will be administered, and spontaneous delivery of the placenta will be awaited using gentle traction. The absence of spontaneous separation of the placenta will confirm the diagnosis of PAS, the patient will undergo to hysterectomy. The complete removal of the uterus will be attempted, including the cervix, the duration of the intervention and intraoperative blood loss will be recorded, as well as the damage to organs neighboring the uterus. In this arm of the study, to hysterectomy will be performed in 100% of patients
15731350|NCT05013749|Procedure|Partial Myometrial Resection|Partial myometrial resection: The technique described by Palacios-Jaraquemada et al5. will be followed. Briefly, the uterus will be dissected to free it from the posterior wall of the bladder to the cervix. The vesico-uterine vessels will be ligated and the parametrial space will be visualized. The hysterotomy will be performed in the upper segment, immediately above the area of invasion of the myometrium. The entire invaded myometrium and the entire placenta will be removed. The uterus will repair itself in one or two layers. Intrauterine balloon tamponade will be used if indicated.
15731353|NCT05013723|Other|Surveys|Mental health validated psychometric surveys: Depression (PHQ-9), Anxiety (GAD-7), PTSD (PC-PTSD-5) Quality of Life surveys: Post COVID-19 Function Status Scale, Quality of life (SF-12)
15731354|NCT05013710|Other|Complete Clinical Interaction|The intervention consists of a completed interaction with the mobile health clinic during the study periods, on which adequate evaluative data was collected on the patient visit (e.g. staff was able to note their visit and reason for visit, the patient met with an healthcare professional, etc)
15731355|NCT05013697|Drug|Paclitaxel + Cisplatin + TQB2450 injection+ Anlotinib|TQB2450 injection: 1200 mg, i.v.gtt , d1;Anlotinib 10mg, po.qd , d1-14；Paclitaxel 135mg/m2, i.v.gtt , d1; Cisplatin 60-75mg/m2, i.v.gtt , d1-d3; The above schemes are repeated every three weeks. After 4-6 cycles, the regimen is changed to Anlotinib (10mg, po.qd , d1-14)+TQB2450 injection（1200 mg, i.v.gtt , d1）. The regimen is repeated every 3 weeks until the disease progresses.
15731356|NCT05013697|Drug|Paclitaxel + Cisplatin + TQB2450 injection|TQB2450 injection: 1200 mg, i.v.gtt , d1;Paclitaxel 135mg/m2, i.v.gtt , d1; Cisplatin 60-75mg/m2, i.v.gtt , d1-d3; The above schemes are repeated every three weeks. After 4-6 cycles, the regimen is changed to TQB2450 injection（1200 mg, i.v.gtt , d1）. The regimen is repeated every 3 weeks until the disease progresses.
15731357|NCT05013684|Other|Particle Repositioning Maneuver|treatment with Particle Repositioning Maneuver
15731358|NCT05013671|Other|repositioning maneuvers|The calcium crystals floating in the endolymphatic fluid will put back in place by putting the patient in several sitting and lying positions during specific repositioning maneuvers. During these maneuvers the calcium crystals will float from the semicircular canals back into the utriculus, after which the dizziness symptoms should disappear
15731359|NCT05013671|Other|balance|compare the balance of residents with BPPV with residents without BPPV
15731360|NCT05013658|Behavioral|pressure measurement|pressure measurement with pilot balloon palpation
15731361|NCT05013645|Other|Sterilized probiotic LfQi601|Sterilized probiotic topically administered.
15731362|NCT05013645|Other|Placebo|Gel control product
15731363|NCT05013632|Drug|Monoclonal antibody|Medications indicated for the treatment of mild to severe COVID-19
15731364|NCT05013619|Other|Circumstances of pain|It will be questioned in which situations the pain occurred in the previous week (at rest from spasms, at rest from splints, on feeding, on moving, on dressing, at night, on exercise, on other treatments, on botulinum toxin application) and record as yes/no.
15731365|NCT05013619|Other|Pain Questionnaire|"Participants will be asked to respond to the initial question Over the past month, have you experienced physical pain? (yes or no). Those responding yes will be asked Please indicate how severe your pain was over the past month, on average, with response options from 1 (very little pain) to 10 (extremely painful). They will be also asked to indicate How much the pain gets in the way of your daily activities over the past month from a low of 1 (does not get in the way at all) to 10 (unable to carry out activities because of the pain). Finally, they will be asked to indicate the body regions in which they experienced pain."
15731366|NCT05013619|Other|Gross Motor Functional Classification System|Severity of CP will be determined based on the Gross Motor Functional Classification System (GMFCS). GMFCS is a standardised measure that classifies gross motor functions in children with CP. Children in level I are very independent in motor functions while those in level V are the least independent
15731367|NCT05013619|Other|The subtypes of Cerebral palsy|The subtypes of CP will be classified, using the Swedish classification, into spastic (tetraplegia, diplegia and hemiplegia), ataxic, dyskinetic and mixed
15731368|NCT05013606|Dietary Supplement|Hydrogen water|This is an over the counter pill supplement that is dissolved in water.
15731434|NCT05013008|Drug|Placebo|Matching placebo to be taken orally, once daily.
15731844|NCT05009784|Other|Long Traffic and Water Sound|Experimental: Long Traffic and Water Sound (Played through speakers)
15732181|NCT05007418|Biological|STI-1492|Anti-CD38 A2 KOKI DAR T cells
15731369|NCT05013593|Dietary Supplement|Red Clover Extract (RCE)|Red clover extract containing isoflavones Formononetin and biochanin A together with a heterogenous culture of probiotic lactic acid bacteria, and a natural sugar free raspberry/orange flavor. Isoflavone amount is 57.45 mg isoflavones daily (55.84 mg aglycones daily), in 70 ml red clover extract (35 ml twice daily, morning and evening together with a meal)
15731370|NCT05013593|Other|Placebo (PL)|Placebo containing water, brown coloring, and natural sugar free raspberry/orange flavor.
15731371|NCT05013580|Procedure|Guided bone regeneration (GBR)|Bone grafts will be placed in the patient's jawbone, along with a membrane to cover the bone grafts. A horizontal incision over the edentulous ridge crest will be made along with vertical incisions if indicated. Buccal and lingual full thickness mucoperiosteal flaps will be reflected to expose the alveolar bone. Intra-marrow penetration (decortication of the alveolar bone to increase vascular supply to the bone grafts) at the surgical site alveolar bone will be made with a high-speed hand piece and diamond bur. Bone allograft material will be placed to fill the alveolar bone defect. The bone graft will then be covered with a membrane and secured with sutures.
15731372|NCT05013567|Drug|Ibuprofen gel|Ibuprofen gel 5% topically four times a day
15731373|NCT05013567|Other|Placebo|Placebo gel topically four times a day
15731374|NCT05013554|Drug|SAR443216|Solution for infusion: IV infusion
15731375|NCT05013541|Other|No intervention|Observational study, standard record of need to void during cystometry
15731376|NCT05013528|Other|Bal-A-Vis-X training|"Bal-A-Vis-X training Performed thrice a week for 10 minutes after baseline assessment Standard Physical therapy treatment along with following exercises.
~ball Rectangle
~ball rectangle and 2 ball drop/pass/catch two-foot jumping forward, tandem walking on ground and tandem walking on the balance beam. ."
15731377|NCT05013528|Other|Aerobic Training Group|"Aerobic training group performed exercises thrice a week for 10 minutes after baseline assessment.
~Standard Physical therapy treatment along with aerobic training as Running is performed"
15731378|NCT05013515|Drug|Surufatinib|"Patients receive oral Surufatinib at a dose of 300mg/d (once-daily dosing continuously, every 28-day treatment cycle), A total of 2 cycles were performed, and efficacy evaluation was performed at the end of each cycle or was determined to be required by the investigator. If disease progression or unacceptable toxicity occurred during the period, induction therapy was terminated early, and after corresponding treatment, surgical treatment was entered as early as possible.
~Surufatinib treatment was interrupted 4-7 days before surgical treatment to maintain organ function; Note: Postoperative radiotherapy or chemoradiotherapy is permitted after radical surgery at the discretion of the investigator."
15731379|NCT05013502|Drug|Empagliflozin 10 MG|empagliflozin 10mg by mouth daily
15731380|NCT05013489|Behavioral|Mindfulness and intercare based intervention|"Eight week online program based on mindfulness, compassion and intercare intervention. A two hour synchronic online session every week plus daily homework based on meditation and journaling exercises.
~The topics covered in the program are mindfulness meditation, cognitive behavioral therapy exercises, gratitude and acceptance, compassion and self compassion exercises, conservation of resources theory and intercare."
15731381|NCT05013476|Combination Product|Butterfly handheld ultrasound machine|Both arms of study will utilize the Butterfly ultrasound machine. Only the virtual learners will utilize zoom for their virtual education
15731382|NCT05013463|Drug|Hydroxychloroquine and Indapamide|Oral Hydroxychloroquine, 200mg BID Oral Indapamide, 2.5 mg OD
15731383|NCT05013450|Drug|Dupilumab|three q3w cycles
15731384|NCT05013450|Drug|PD-1/PD-L1 blockade|SOC immunotherapy with PD-1/PD-L1 blockade
15731385|NCT05013437|Drug|Evomela|16 mg/m^2 Evomela administered one time via a central line
15731386|NCT05013437|Device|Next Generation Sequencing|Next Generation Sequencing
15731387|NCT05013437|Drug|Prochlorperazine|10mg once intravenous (IV) within 30 minutes before Evomela
15731388|NCT05013437|Drug|Acetaminophen|650 mg once orally within 30 minutes before Evomela
15731389|NCT05013437|Drug|Diphenhydramine|50 mg once intravenously within 30 minutes before Evomela
15731390|NCT05013424|Drug|OnabotulinumtoxinA|Intramuscular Injection
15731391|NCT05013411|Other|Qualitative study|Individual interviews and focus groups will be conducted to explore current strengthens and barriers in obtaining patient observations. Views on use of technology in assisting with patient observations will also be discussed and documented.
15731392|NCT05013398|Behavioral|The Together Webinar Programme|"The TTP-Webinar consists of six hour-long sessions. Each session focuses on psychoeducation and self-management strategies for supporting veteran mental health difficulties as well as self-management tools to enhance partners' own wellbeing.
~The TTP-Webinar treatment protocol incorporates a range of techniques used in Cognitive Behavioral Therapy (CBT), Dialectical Behavioral Therapy (DBT), Compassion Focused Therapy (CFT), and Acceptance and Commitment Therapy (ACT)."
15731393|NCT05013385|Drug|Spesolimab|Spesolimab
15731394|NCT05013385|Drug|Placebo|Placebo
15731395|NCT05013372|Drug|CD147- CAR T cells|CAR T cells targeting CD147
15731396|NCT05013359|Other|No treatment given|No treatment given
15731397|NCT05013346|Other|No intervention needed|No intervention required. Not a clinical trial
15731398|NCT05013333|Device|AED 3 with Uni-padz|Use of AED 3 with Uni-padz by lay rescuer
15731399|NCT05013320|Drug|Glycopyrrolate + dexmedetomidine|Intravenous glycopyrrolate before anesthetic induction. Dexmedetomidine administration during the surgery.
15731400|NCT05013320|Drug|Dexmedetomidine|Dexmedetomidine administration during the surgery.
15731401|NCT05013307|Other|CASE|"Cognitive testing will be completed on iPad. Across all tasks, users are instructed to respond to visual and audial stimuli by touching the screen in the correct location within preset time constraints. The assessment will consist of seven tasks designed to measure core cognitive function.
~The Clinical Assessment for Sports Exertion (CASE) addresses the physical performance of athletes by quantifying physiological and symptomatic responses to dynamic exertion. It was developed by clinicians at the Baylor Scott and White Sports Concussion Program in an effort to identify specific system impairments in athletes who were unable to successfully demonstrate readiness for return to play protocols."
15731402|NCT05013294|Other|Intervention|Text messages through a basic phone or smart phone
15731759|NCT05010291|Behavioral|Altruism framed text message reminder to attend clinic appointment|Altruism framed one-way text message reminding recipient of care to either 1) attend a scheduled clinic appointment or 2) visit the clinic after a missed appointment.
15731403|NCT05013281|Procedure|Suprachoroidal hemorrhage associated with pars plana vitrectomy|SCH has a higher incidence rate after a second intraocular surgery in a vitrectomized eye which is associated with the lack of vitreous support and easier fluctuation of intraocular pressure. SCH associated with PPV is more localized and has a relatively good prognosis; high myopia and aphakic/ pseudophakic eyes are risk factors. Active treatment can effectively improve visual prognosis.
15731404|NCT05013268|Drug|Tislelizumab, paclitaxel/docetaxel, cisplatin/carboplatin|"Drug: Tislelizumab 200mg, d1, ivgtt, every 3 weeks, for 3 cycles
~Drug: Paclitaxel; docetaxel Dose: 175mg/m2 d1; 75mg/m2 d1, every 3 weeks, for 3 cycles Other Name: none
~Drug: Cisplatin; Carboplatin Dose: 75mg/m2 d1; AUC=5, d1, every 3 weeks, for 3 cycles Other Name: none"
15731405|NCT05013255|Drug|Pioglitazone 15mg|PIO 15mg orally once daily for 2 weeks
15731406|NCT05013255|Drug|Pioglitazone 30 mg|PIO 30mg orally once daily for 2 weeks
15731412|NCT05013216|Drug|KRAS peptide vaccine|"KRAS peptide vaccine will be administered on Prime week 1, 3, and 5. Boost vaccinations with will be administered at week 13.
~Drug: 1.8 mg KRAS peptide vaccine + 0.5mg Poly-ICLC"
15731413|NCT05013203|Diagnostic Test|Tissue culture|Discarded tissue collected during surgery will be sent to the hospital microbiological lab for aerobic and anaerobic
15731414|NCT05013203|Diagnostic Test|Next Generation Sequencing|Discarded tissue collected during surgery will be sent to an outside lab for testing using next generation sequencing (NGS)
15731415|NCT05013190|Other|No intervention|This is a non-interventional study.
15731416|NCT05013164|Drug|Folinic Acid|Folinic Acid was given at the dose of 2mg/kg per day in two divide doses( maximum 50 mg per day) given for 12 weeks
15731417|NCT05013151|Dietary Supplement|Dates|Consumption of 6 dates a days until 41 weeks of gestation
15731418|NCT05013151|Dietary Supplement|Castor oil|One time consumption of 60 CC Castor oil
15731419|NCT05013138|Behavioral|Training for ACEs and study procedures|"The providers will lead a resilience-based conversation discussion regarding the impact of caregiver ACEs, after receiving training for ACEs and study procedures.
~The first training component will provide an overview of ACEs using the ACE Interface Training. The second training component will address the implementation of the caregiver ACEs screening in the clinic."
15731420|NCT05013138|Behavioral|Training on study procedures|Instead of ACEs training, standard of care providers will undergo training on study procedures including obtaining survey instruments from caregivers and proper storage of survey instruments. This training will stress the importance of not reviewing caregiver ACE scores and minimizing possible treatment contamination.
15731421|NCT05013125|Diagnostic Test|ENDO-AID CADe assisted Colonoscopy|ENDO-AID is a dedicated endoscopy Computer-Aided Diagnosis (CADe) system where suspicious lesions are automatically detected and highlighted on the main monitor in real-time, alerting the endoscopist during the procedure.
15731422|NCT05013112|Drug|SGLT2 inhibitor|Empagliflozin 20mg once daily from discharge
15731423|NCT05013112|Drug|Metformin|Metformin 500mg twice daily from discharge
15731424|NCT05013112|Other|Placebo|Placebo group
15731425|NCT05013099|Biological|89Zr-Df-Crefmirlimab|Up to three 89Zr-Df-crefmirlimab PET scans (up to 1.0 mCi ± 20% at 1.5 mg API per scan, for a total of up to 3.0 mCi ± 20% and 4.5 mg API) as an IV infusion as follows: First (PETbaseline) within 14 days prior to the onset of IOT, and a second (PETEOC1) 4 to 6 weeks after start of immunotherapy. The second 89Zr-Df-crefmirlimab infusion and scan (PETEOC1) should be completed prior to the start of the third cycle of IOT. Subjects who are determined by the treating physician to have PD on immunotherapy can receive the optional third 89Zr-Df-crefmirlimab PET scan at the principal investigator's (PI's) discretion.
15731427|NCT05013073|Other|ASTHMAXcel ED Application|A mobile application designed to assist patients in asthma symptom recognition, treatment best practices, and trigger identification.
15731428|NCT05013060|Dietary Supplement|Probiotics and microcapsulated sodium butyrate|The patients who give their consent to take part in this study, will receive an oral microencapsulated sodium butyrate and a mixture of probiotics formulation 2 times a day for a period of 12 weeks.
15731429|NCT05013060|Dietary Supplement|Maltodextrin|The patients who give their consent to take part in this study will receive an oral maltodextrin as placebo 2 times a day for a period of 12 weeks.
15731430|NCT05013034|Drug|Basiliximab Injection|Subjects will be given IV dosing with basiliximab up to a maximum of 2 treatments (day 0 and day 4) for all patients on study. Treatment for patients may stop for unacceptable side-effects, the Investigator's, or patient's decision to discontinue treatment or other reasons. Exclusion for second dose is first dose returned patient to SpO2 ≥94% on room air.
15731431|NCT05013034|Drug|Placebo|Subjects will be given IV dosing with placebo (1/2 normal saline) up to a maximum of 2 treatments (day 0 and day 4) for all patients on study. Treatment for patients may stop for unacceptable side-effects, the Investigator's, or patient's decision to discontinue treatment or other reasons. Exclusion for second dose is first dose returned patient to SpO2 ≥94% on room air.
15731432|NCT05013021|Other|Sprint Interval Training|"The Sprint Interval Training (SIT) training consists of 3 successive blocks of 5 training sessions each. The sessions are 24 to 48 hours apart.
~. One block lasts two weeks. After the end of one block, the following block begins the day after.
~The Sprint Interval Training lasts 6 weeks.
~Each session consists of a series of sprints, the number of which varies from 8 to 14. Thus a session will last from 30 to 45 min approximately
~So, the time frame of this study is Baseline, Block 1, Block 2 and Block 3 (Not in day or week or month)"
15731433|NCT05013008|Drug|Finerenone (BAY94-8862)|10 mg or 20 mg finerenone tablet to be given orally, once daily.
15731435|NCT05012982|Device|AirBand|The AirBands will be placed at each of the two training sessions and inflated while an ultrasound probe is placed over the femoral artery. The cuff will be inflated until the artery reaches 60% occlusion. The force will be applied using a wireless Bluetooth signal; participants will not be asked to adjust the device. Participants will be observed by a certified Personal Therapist throughout the training session in order to determine compliance and ensure safety as is standard protocol for a physical therapy session.
15731436|NCT05012982|Device|uninflated AirBand|Uninflated AirBand will be used as the control intervention during the session in which BFR is not performed
15731437|NCT05012969|Device|Hipstop bandage|12 weeks use of a bandage to prevent hip dislocations in patients with previous dislocations
15731438|NCT05012956|Procedure|Laparoscopic sacrocolpopexy|During laparoscopic sacrocolpopexy, the anatomical position of the vaginal vault and cervix (if present) is restored by suturing a surgical mesh to the vaginal cuff or cervix and variable portions of the anterior and posterior vagina, while connecting the other end of the mesh to the anterior longitudinal ligament over the sacrum.
15731439|NCT05012956|Procedure|gynecologic laparoscopic surgery|Gynecologic laparoscopic surgery at UZ Leuven, other than sacrocolpopexy
15731442|NCT05012930|Other|Baby Foods - Meat|Commercially available baby foods
15731443|NCT05012930|Other|Baby Foods - Dairy|Commercially available baby foods
15731444|NCT05012930|Other|Baby Foods - Plant|Commercially available baby foods
15731445|NCT05012930|Other|Foods from the home|Caregiver will provide participant with usual foods from the home
15731446|NCT05012917|Other|Patient/Proxy-SSPedi|"SSPedi and Mini-SSPedi: SSPedi is a symptom assessment scale for children 8-18 years of age that includes 15 symptoms considered most important by children receiving cancer treatment or HSCT, their parents and healthcare professionals. Each symptom is rated on a 5-point Likert scale consisting of 0=not at all bothered, 1=a little, 2=medium, 3=a lot and 4=extremely bothered. The recall period is yesterday or today.
~Mini-SSPedi was developed for children 4-7 years of age and is comprised of the same 15 symptoms. Mini-SSPedi has a recall period of today with a 3-point Likert scale consisting of 0=not at all bothered, 2=medium and 4=extremely bothered'. So, the anchors and mid-point are identical to SSPedi. A faces-type scale accompanies the response options and the symptom descriptions are simplified.
~Proxy-SSPedi: Proxy-SSPedi is identical to SSPedi except that the leading question refers to your child rather than you. It is designed for children 2-18 years of age."
15731447|NCT05012917|Other|Co-SSPedi|"Co-SSPedi: Co-SSPedi is based upon either SSPedi (age 8-18) or mini-SSPedi (age 4-7).
~Co-SSPedi is meant to be completed by both child and parent together. The format and wording is identical to self-report SSPedi and mini-SSPedi (depending on child age) to maximize the ability of the child to participate in symptom reporting.
~The approach uses written instruction that asks the dyad who will hold the device and enter the agreed-upon scores. The instruction then asks one member to read the leading question, each symptom and response options out loud. The child answers how bothered they are by that symptom out loud. The parent then states if they agree or they can offer a different answer. If the answer is different, the instruction asks the dyad to discuss until they agree upon an answer. The agreed-upon answer is then entered into co-SSPedi. This process is repeated for the remaining 14 symptoms."
15731448|NCT05012904|Behavioral|parent support application|To provide support, parents held children on their laps, holding the extremity from which the blood was drawn, holding the children's hands, and communicating with their children during the process in the child's room.
15731449|NCT05012891|Other|OneStep Smartphone Application|"OneStep technology is a smartphone application (app) utilizing smartphone sensors to provide ongoing gait diagnostics. The eligible study participants will be asked to download and install the app on their own smartphones and carry the smartphone in their front pants pocket at all times.
~The app will collect the required gait parameters but, will not present them (or any summary thereof) to the study participants or their physiotherapists, in order not to influence the rehabilitation plan."
15731450|NCT05012878|Behavioral|Cardiac rehabilitation - high intensity interval training (HIIT)|During cardiac rehabilitation (12-weeks, 3 sessions/week), exercise training will comprise of 4x4-min high intensity aerobic intervals at a rating of perceived exertion 15-17 (hard to very hard), interspersed by a 3-min active recovery at a rating of perceived exertion 11-13 (fairly light to somewhat hard). Warm-up (4-min) and cool-down (3-min) at a light intensity.
15731451|NCT05012878|Behavioral|Cardiac rehabilitation - moderate intensity continuous training (MICT)|During cardiac rehabilitation (12-weeks, 3 sessions/week), exercise training will comprise of 34-min of continuous aerobic exercise at a rating of perceived exertion 11-13 (fairly light to somewhat hard). Warm-up (3-min) and cool-down (3-min) at a light intensity.
15731452|NCT05012878|Behavioral|Cardiac rehabilitation - control|Participants will receive exercise advice in line with usual hospital discharge procedures. This involves exercise physiologists providing verbal and written information on achieving the national physical activity guidelines (150min/week of moderate intensity exercise) 60 and range of movement exercises for surgical patients with sternotomy. However, no structured or supervised exercise training program or other contact with participants will be provided after hospital discharge, to reflect the usual care process for patients that decline cardiac rehabilitation.
15731453|NCT05012865|Drug|avelumab|as provided in real world practice
15731454|NCT05012865|Drug|axitinib|as provided in real world practice
15731455|NCT05012852|Device|VagiVitalAC|In the Pilot part, the single intervention used is VagiVitalAC treatment for 30 days. In the randomized part, patients in the Interventional arm are treated with VagiVital AC for up to 90 days.
15731456|NCT05012839|Other|impact of COVID-19 on Health-Seeking Behaviors|The impact of the coronavirus disease 2019 (COVID-19) pandemic on medical services is overwhelming due to limited medical resources. During its initial surge in 2020, Taiwan's government rapidly established diverse public actions, which helped maintain the medical supply without travel restrictions. However, whether the fear of being infected with COVID-19 interfered with health-seeking behavior (HSB) remains unclear. Therefore, this study aimed to elucidate whether acute complicated appendicitis (ACA) rates in adults were affected by the COVID-19 pandemic.
15731760|NCT05010278|Procedure|Latarjet|Patients followed up 6 months after a Latarjet procedure
15732185|NCT05007392|Other|Dotinurad Matched Placebo|Dotinurad matched placebo oral tablets.
15731457|NCT05012826|Other|Osteopathic Manipulative Treatment in addition to Physiotherapy|Participants in this group will receive OMT in addition to the same interventions of PT group. The frequency of treatment will be decided based on the clinical judgment of the osteopath who is accompanying each case, not exceeding 7 consultations in total. At each visit, the participants will receive a full-body osteopathic examination which include clinical exams, observation, screening tests, palpation, and motion testing. The OMT entail direct (high-velocity low-amplitude; muscle energy; and myofascial release), indirect (functional techniques and balanced ligamentous tension), visceral, and cranial techniques(Giusti, 2017). Selection of specific OMT will follow the 'TART' criteria-Tissue texture changes, Asymmetry, Restriction of motion, Tenderness (Basile et al., 2017; Cerritelli et al., 2011; Giusti R., 2017; Pizzolorusso et al., 2011; Seffinger M.A, 2018).
15731458|NCT05012826|Other|Physiotherapy|Participants in this group will receive physiotherapy sessions with a maximum frequency of 2 weekly sessions, as defined by the physiotherapist, according to personalized therapeutic plans for a period of 8 weeks. The physiotherapy approach for patients with long COVID includes motor and respiratory rehabilitation aiming at maintaining and/or improving joint mobility, muscle strength, and functional exercise capacity (Thomas et al., 2020). At each visit, the participants respond by self-report about their general condition. Depending on the case, the physiotherapist will perform a reevaluation with specific tests. The PT group will receive physiotherapy treatment offered by five physiotherapists, with more than 5 years of experience each, duly registered with their class council.
15731459|NCT05012813|Other|Aromatherapy with Essential Oils and Virtual Reality|Participate in SFIT this is one intervention with Virtual Reality (VR) and aroma therapy with essential Forest oils
15731460|NCT05012800|Biological|COVID-19 Vaccine|Coronavirus vaccine was inoculated on day 0 and day 21, respectively.
15731461|NCT05012787|Biological|CpG 1018/Alum-adjuvanted SCB-2019 vaccine|Participants will receive 1 intramuscular (IM) injection of 30 microgram (mcg) SCB-2019 with CpG 1018/Alum adjuvant on Day 1 and on Day 22.
15731462|NCT05012787|Biological|Havrix|Participants will receive Havrix (Hepatitis A vaccine) containing 1440 Enzyme-linked Immunosorbent Assay (ELISA) units (EL.U.) in 1.0 mL dose on Day 1.
15731463|NCT05012787|Other|Placebo; 0.9% saline|Participants will receive 1 IM injection of SCB-2019-matching placebo on Day 22.
15731464|NCT05012774|Behavioral|Speech Recognition Training|Training for each training arm takes place over 10 sessions carried out at home. on the participant's own computer without experimenter direct supervision. Pre- and post-training tests are carried out under experimenter supervision.
15731465|NCT05012761|Drug|SR419 capsules|Ascending single and multiple doses of SR419 orally
15731466|NCT05012761|Drug|Placebo|Ascending single and multiple doses of placebo orally
15731467|NCT05012748|Other|Ketogenic diet|The ketogenic diet will consist of 75% fat, 20% protein and 5% carbohydrates. The diet will be standardised and matched to the energy consumption of each participant. The diet does not dictate time of consumptions. The food regime will be strictly followed every day for 3 weeks, where the investigator will contact the participants every day to secure adherence.
15731468|NCT05012735|Drug|Study Cleanser (Neutrogena Ultra Gentle Daily Cleanser with Pro Vitamin B5)|Participants will wash their face with the study cleanser (Neutrogena Ultra Gentle Daily Cleanser with Pro Vitamin B5) for up to 14 days.
15731469|NCT05012735|Device|Prototype Ultrathin Hydrocolloid Bandage|Participants will cover their closed and popped pimples in the evening with one or two bandages from Days 0 through 6.
15731470|NCT05012722|Other|No intervention|No intervention, all patients included in this study will have a pulse wave velocity measurement measured using SphygmoCor cardiovascular management system (CVMS) (Atocr Medical, Sydney Australia) which is a tonometry-based device used to noninvasively obtain vital cardiovascular data.
15731471|NCT05012709|Behavioral|multisensory stimulation therapy|The intervention group received six 30-minute MST sessions. During MST session, participants can choose their preferred sensory stimuli such as essential oil diffuses, music and so on.
15731472|NCT05012696|Device|Non-invasive ventilation (NIV)|Non-invasive ventilation will be provided through a mechanical ventilator (Carina, Dräger) through a facial interface (Fitlife Respironics, Philips). A PEEP level between 5 and 10 cmH2O, minimal pressure-support level of 5 cm H2O targeting a tidal volume around 6 to 8 ml/kg and at the same FiO2 applied during the spontaneous breathing trial.
15731473|NCT05012696|Device|High-flow nasal cannula|High flow nasal cannula will be provided through a commercial device (AIRVO2 + Optiflow nasal cannula, Fisher & Paykel), at 50 LPM and at the same FiO2 applied during the spontaneous breathing trial.
15731474|NCT05012683|Device|Point Partial|Patient is fit with Point Partial partial finger prosthetic system
15731475|NCT05012670|Drug|[14C]-Paxalisib Capsule|Each subject will receive a single dose 15 mg (NMT 3.5 MBq), administered orally in the fasted state with with 240 mL water.
15731476|NCT05012657|Device|Point Partial|The Point Partial partial finger prosthetic system consists of 1-4 ratcheting mechanical partial digits and mounting brackets
15731477|NCT05012644|Drug|Palbociclib + aromatase inhibitor|Palbociclib + aromatase inhibitor
15731478|NCT05012644|Drug|Aromatase inhibitor|Aromatase inhibitor
15731479|NCT05012631|Drug|Losartan|Losartan dosing for participants <16 years will be 0.7 mg/kg (maximum of 50 mg) once daily. The dose can be increased to 1.4 mg/kg (maximum of 100 mg once daily) after 2 weeks if the dose was tolerated (no hypotension or hyperkalemia). For patients ≥16 years, the starting dose will be 50 mg once daily which can be increased to 100 mg daily if tolerated after 2 weeks.
15731480|NCT05012618|Drug|LUNA18|LUNA18 Capsule
15731481|NCT05012605|Other|Observation|Observe physical function and sleep disorder symptoms following stroke
15731515|NCT05012254|Drug|Ipilimumab|"Patients will receive Ipilimumab 1mg/Kg administered by IV infusion every 42 days (Q6W) until disease progression, unacceptable toxicity, loss of clinical benefit as judged by the investigator or up to a maximum of 2 years of treatment.
~Structure: is a fully human monoclonal antibody with two heavy chains and two kappa light chains linked together by way of disulfide bonds. The molecular weight is approximately 148 kDa and it exists in solution at a physiologic pH of 7.0.
~Route of administration: Intravenous infusion."
15731761|NCT05010265|Other|Clinician Questionnaire|Surveys will serve to identify preferences, expectations and concerns among clinicians and researchers surrounding data-sharing of uncertain diagnostic data generated through investigative neurotechnologies which will then be systematically evaluated.
15732186|NCT05007392|Other|Febuxostat Matched Placebo|Febuxostat matched placebo oral tablets.
15731482|NCT05012592|Behavioral|Health Awareness Program TO Reduce Malnutrition and Helminth Infestation among Primary School children|This interventional study period will be started from August 2021 up to September 2022 (14 months) by school nurses to implement HAPSC. After completing four to five months of the educational session the school nurse will collect midline follow-up data and the endline data will be collected at the end of the interventional study. In this period a total of nine months (except annual leave) will be considered as an interventional education period. The intervention group will receive one educational session per week every month. Two school nurses will be assigned for each class to provide health education. Each session will be conducted for a maximum of 45 minutes. The community worker will be assigned to assist the school nurse and they will communicate with the child's parents about their child's healthy nutrition and good hygiene practice. The significance of healthy eating and hygiene behavior for the children will be shared with the child's parents or guardians properly.
15731483|NCT05012579|Device|Cala Device|transcutaneous afferent patterned stimulation (TAPS)
15731484|NCT05012566|Device|Juvederm|"Juvederm Volbella: 15mg/ml, it is injected 1.5ml per patient per treatment (a total of 3ml per patient split in 2 treatment sessions at a 4 months interval);
~Juvederm Volifit: 17.5mg/ml, it is injected 3ml per patient per treatment (a total of 3ml per patient split in 2 treatment sessions at a 4 months interval);
~Juvederm Voluma: 20mg/ml, it is injected 5ml per patient per treatment (a total of 3ml per patient split in 2 treatment sessions at a 4 months interval)"
15731485|NCT05012566|Drug|Vistabex|Vistabex: 50U/vial, it is injected up to 80U per patient per treatment (2 treatment sessions at a 4 months interval)
15731486|NCT05012553|Other|education of self and peer assesment|Stoma care skill achievement is expected to be higher in the group that received self- and peer-assessment training compared to the group that did not receive training.
15731487|NCT05012514|Device|LLLT RED|"Participants received seven sessions of PBMT LED twice a week, the last session being about twenty minutes before the surgical procedure of bariatric surgery. The therapy was performed on the left side of the abdominal region following the linea alba of all research participants and the right side was considered as control, for application they will receive eye protection, using goggles for safety, the abdomen of the participants will be cleaned by using a neutral cleansing soap. A cluster applicator was used using the parameters described in table 1.
~For therapy, the equipment Antares® was used, IBRAMED- Indústria Brasileira de Equipamentos Eletromédicos EIRELI [EIRELI Brazilian Industry of Electromedical Equipment], approved by Anvisa Nº 10360310037. Figure 1."
15731488|NCT05012501|Diagnostic Test|test NETs markers|NETs markers (Myeloperoxidase, Neutrophil elastase, Citrate histone H3), tissue factor, endotoxin, factor X, TAT complex, and anti-β2 glycoprotein I were detected in plasma using capture ELISA and specific ELISA kits.
15731490|NCT05012475|Behavioral|Modified Virtual Reality Gaming|Investigators customize each gaming session based on the motivators and interests of each participant. The intervention facilitates independent hand separations (minimizing stereotypies) and encourages independent arm/hand movement that serves to activate or control the computer-generated activities.
15731491|NCT05012462|Device|CM-1500|The CM-1500 is a U.S. FDA cleared non-invasive monitoring device that simultaneously monitors five (5) parameters of a patient's body. A combination of these parameters is represented by a single number known as the Relative Index value. This value is indicative of relative changes in fluid volume.
15731492|NCT05012449|Procedure|Arthrography-assisted joystick technology.|Arthrography-assisted joystick technology.
15731493|NCT05012436|Drug|YHD1119 75mg|A single oral dose
15731494|NCT05012423|Drug|Placebo|"Matching Placebo
~Placebo will be administered as oral capsules."
15731495|NCT05012423|Drug|ECC0509|"ECC0509 1 mg and 10 mg capsules
~ECC0509 will be administered as oral capsules."
15731496|NCT05012423|Drug|Placebo|"Matching Placebo
~Placebo will be given orally during each dosing day."
15731497|NCT05012423|Drug|ECC0509|"ECC0509 1 mg and 10 mg capsules
~Placebo will be given orally during each dosing day."
15731498|NCT05012410|Behavioral|Immediate treatment group with High-Intensity Prompts|Caregivers in the immediate treatment group with high-intensity prompts will use the WeCareAdvisor tool for 6 months. Caregivers will receive telephone and email prompts to use the tool.
15731499|NCT05012410|Behavioral|Immediate treatment group with Low-Intensity Prompts|Caregivers in the immediate treatment group with low-intensity prompts will use the WeCareAdvisor tool for 6 months. Caregivers will receive email prompts to use the tool.
15731500|NCT05012410|Behavioral|Waitlist Control after three months with High-Intensity Prompts|After 3 months, caregivers will use the WeCareAdvisor tool for 3 months. Caregivers will receive telephone and email prompts. Once the caregiver receives the WeCareAdvisor tool, they will receive a weekly automated email as well as a weekly telephone call from study staff to prompt them to use the tool.
15731501|NCT05012410|Behavioral|Waitlist Control after three months with Low-Intensity Prompts|After 3 months, caregivers will use the WeCareAdvisor tool for 3 months. Caregivers will receive email prompts.
15731502|NCT05012397|Drug|RAIN-32|260 mg once daily orally on Days 1 to 3 and Days 15 to 17 of each 28-day cycle
15731503|NCT05012384|Other|Vergence exercises (Orthoptic exercises)|Vergence exercises as described by the Convergence Insufficiency Treatment Trials Group (CITT)
15731504|NCT05012384|Genetic|Placebo|Generic management plan with non-visual elements
15731505|NCT05012371|Drug|Cabozantinib|Given PO
15731506|NCT05012371|Drug|Everolimus|Given PO
15731507|NCT05012371|Drug|Lenvatinib|Given PO
15731508|NCT05012371|Other|Questionnaire Administration|Ancillary studies
15731509|NCT05012345|Procedure|Below Elbow cast|below-elbow cast ( 4 or 6 weeks )
15731510|NCT05012332|Procedure|Erector Spinae Plane Block|All volunteers receive an Erector Spinae Plane Block and an MRI.
15731511|NCT05012319|Drug|to be given as a treatment|"Nitric Oxide Nasal Spray Enovid"
15731512|NCT05012293|Other|Baseline|5-min urban park video clip (Presented on a TV)
15731513|NCT05012293|Other|Fatigue Manipulation|20-min 2-back task (Presented on a computer)
15731516|NCT05012254|Drug|Nivolumab|"Patients will receive Nivolumab 360 mg administered by IV infusion every 21 days (Q3W) until disease progression, unacceptable toxicity, loss of clinical benefit as judged by the investigator or up to a maximum of 2 years of treatment.
~Structure: Nivolumab is a soluble protein consisting of 4 polypeptide chains, which include 2 identical heavy chains and 2 identical light chains.
~Route of administration: Intravenous infusion."
15731517|NCT05012254|Drug|Carboplatin|"Patients will receive Carboplatin AUC 5 or 6 administered by IV infusion every 21 days (Q3W), for 2 cycles.
~Structure: The cis-diamino (cyclobutane-1, 1 dicarboxylate) platin. Stability: 24 hours at ambient temperature in 5% glucose, glucosa or physiologic saline. It is recommended not to dilute with chlorinated solutions since this could affect the carboplatin.
~Route of administration: Intravenous infusion. Guidelines of Carboplatin administration: According to the standard of each center."
15731518|NCT05012254|Drug|Cisplatin|"Patients will receive Cisplatin 75mg/m2 administered by IV infusion every 21 days (Q3W), for 2 cycles.
~Structure: (CAS No. 15663-27-1, MF-Cl2H6N2Pt; NCF-119875), cisplatinum, also called cis-diamminedichloroplatinum(II), is a metallic (platinum) coordination compound with a square planar geometry. It is a white or deep yellow to yellow-orange crystalline powder at room temperature.
~Stability: Do not store above 25°C. Do not refrigerate or freeze. Keep container in the outer carton to protect from light. Following dilution in 0.9% sodium chloride injection, chemical and physical in-use stability has been demonstrated for up to 14 days at 20°C.
~Route of administration: Intravenous infusion. Guidelines of Cisplatin administration: According to the standard of each center."
15731519|NCT05012254|Drug|Paclitaxel|"Patients will receive Paclitaxel 200mg/m2 administered by IV infusion every 21 days (Q3W), for 2 cycles.
~Structure: A diterpene whose composition is: 5b, 20-epoxy-1, 2a, 4,7b, 10b, 13a-hexahidroxytax-11-en 9 one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)- N-benzoyl-3-phenylisoserine.
~Stability: Concentrations of 0.3-1.2 mg/ml in 5% dextrose or normal saline have demonstrated chemical and physical stability for more that 27 hours at ambient temperature (25ºC approximately). The intact vial must be stored between 15º and 25ºC.
~Guidelines of Paclitaxel administration: Paclitaxel must be administered by infusion over 3 hours in dextrose (D5W) or normal saline (NS). The concentration must not exceed 1.2 mg/ml."
15731520|NCT05012254|Drug|Pemetrexed|"Patients will receive Pemetrexed 500mg/m2 administered by IV infusion every 21 days (Q3W), for 2 cycles.
~Structure: Pemetrexed disodium (ALIMTA®, pemetrexed) is a novel pyrrol [2,3 d]-pyrimidine based folic acid analogue.
~Route of administration: Intravenous infusion. Guidelines of Pemetrexed administration: According to the standard of each center"
15731521|NCT05012241|Diagnostic Test|Nine Hole Peg Test|At first, each patient will be asked to fill in the questionnaire. Then he/she will be tested by the Nine Hole Peg Test according to the new Czech version of extended manual for this test. Audio recording of verbal instructions will be used.
15731522|NCT05012215|Procedure|Paravertebral|Ultrasound-guided paravertebral block
15731523|NCT05012215|Procedure|Caudal block|Caudal block
15731525|NCT05012189|Drug|Oseltamivir|Nursing home residents and staff 18 years and older are allocated to receive oseltamivir for treatment and chemoprophylaxis for influenza.
15731526|NCT05012189|Drug|Baloxavir|Nursing home residents and staff 18 years and older are allocated to receive baloxavir for treatment and chemoprophylaxis for influenza.
15731527|NCT05012176|Behavioral|Behavioral Intervention|Participate in EFT
15731528|NCT05012176|Behavioral|Behavioral Intervention|Participate in ERT
15731529|NCT05012176|Other|Quality-of-Life Assessment|Ancillary studies
15731530|NCT05012176|Other|Questionnaire Administration|Ancillary studies
15731531|NCT05012163|Behavioral|Reminder|Letter, short message service (SMS) text, phone, and/or email
15731532|NCT05012163|Behavioral|Financial incentive|Letter, SMS, phone, and/or email
15731533|NCT05012163|Behavioral|Lottery|Letter, SMS, phone, and/or email
15731534|NCT05012137|Procedure|Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block (SASIS-FICB) with 0.5% ropivacaine|all the patients received Ultrasound-guided Supra-anterior Superior Iliac Spine Fascia Iliaca Compartment Block (SASIS-FICB)
15731535|NCT05012137|Drug|different volume of 0.5% ropivacaine|According to the subject's response to the injection dose, the next subject will be injected with a different volume of the drug according to the preset rules
15731536|NCT05012124|Other|Best Practice|Receive u-CoCM
15731537|NCT05012124|Other|Interview|Participate in interview
15731538|NCT05012124|Other|Media Intervention|Use t-CoCM digital platform
15731539|NCT05012124|Other|Survey Administration|Complete survey
15731541|NCT05012085|Other|Investigation of Global Interest in Global Surgery|"The investigators searched the terms global surgery and global health on Google Trends (Google Inc., CA, USA) from January 2004 to May 2021. The investigators identified time trends and compared the two search terms using SPSS v26 (IBM, WA, USA) to run summary descriptive analyses and Wilcoxon rank-sum tests."
15731542|NCT05012072|Behavioral|The Mastery Lifestyle Intervention|Combination cognitive behavioral intervention of phase 3 CBT using ACT and PST
15731546|NCT05012033|Other|No intervention - prednisolone is taken as part if routine clinical care.|Prednisolone given orally prior to taking timed samples for levels
15731547|NCT05012020|Device|mHealth Remote Monitoring platform|Clinic Portal and Mobile Application for remote monitoring of Chronic Kidney Disease patients and patients on Peritoneal Dialysis
15731548|NCT05012007|Other|Reminder Phone|Standard reminder via phone (audiocare)
15731549|NCT05012007|Other|Reminder Text|reminder via text (VEText)
15731916|NCT05009368|Drug|Drug: Treatment A|CTL0901, single dose, daily, repeated oral administration for 4 days
15731550|NCT05011994|Behavioral|Maintenance intervention|"The intervention consists of action planning, text messages, and coordinator support.
~At onset, each participant creates an action plan for physical activity with the help of a health professional:
~What types of physical activities?
~When and how often?
~Where and with who?
~2 auto-generated text messages are sent weekly for a duration of 12 weeks. The first prompts physical activity. The second asks if plans were reached. If yes, an automatic reply with positive reinforcement is generated. If no, an automatic reply asks if the participant wants to be contacted.
~Participants are contacted by a coordinator either by answering text messages or if not answering the texts for a period of 2 weeks or more. Coordinator functions:
~Call participants replying to texts that they wish to be contacted
~Help participants establish contact to local activities involving physical activity
~Follow-up on and adjustment of action plan
~Offer guidance in physical activity"
15731551|NCT05011981|Device|Left Atrial Appendage Occlusion|Interventional left atrial appendage occlusion with the Amulet or Watchman device
15731552|NCT05011968|Dietary Supplement|Lettuce with not biofortification|Lettuce without any biofortification was assigned to each participant belonging to the control group which ate 100gr every day for 10 days
15731553|NCT05011968|Dietary Supplement|Lettuce biofortificated with Iodine|Lettuce with Iodine biofortification was assigned to each participant belonging to the intervention group which ate 100gr every day for 10 days
15731554|NCT05011955|Behavioral|Mindfulness, compassion and intercare based Intervention|"The mindfulness based intervention was a short version of the Mindfulness based intercare program (IBAP). The intervention consists of four synchronic group sessions via ZOOM of one hour each, one peer week and home practice. A total of four groups were conducted of 15 students each.
~The IBAP program was inspired by first and second generation mindfulness based interventions, such as Mindfulness based cognitive training, Self-Compassion and Cognitive based Compassion training. Also compassionate communication, conservation of resource theory and habits theory.
~Each module consists in meditation practices, inquiry and self or group reflections on different topics such as mindfulness, automatic pilot, mind wandering , acceptance, gratitude and compassion, care resources and intercare."
15731555|NCT05011955|Behavioral|Psychoeducational based intervention|Four week, one hour peer week, online group intervention plus home work base on psychoeducation about stress, anxiety, selfcare and effective communication. Plus general curricular intervention. Delivered by psychologist.
15731556|NCT05011955|Other|General curricular intervention|"All participants were offered psychological sessions if a high score on depression or anxiety symptoms were detected. Psychological sessions consists of 4 to 8 sessions with specific objectives and then referral to continue the mental health process according to the student's welfare system.
~Participants also have academic breaks of two week per semester, apart from holidays, and academic flexibility in submitting work, attending practical activities and taking exams."
15731557|NCT05011942|Device|Irrisept Irrigation solution|ii. Irrigation (Irrisept vs control of normal saline) used after initial skin inicision prior to coming through fascia, after placement of instrumentation (screws, hooks), prior to placement of bone graft, and after fascial closure iii. Irrigation exposure/soak time to be 1 min for each irrigation time point. iv. 1 bottle (450 mL) Irrisept irrigation to be used during case with normal saline rinse to follow at each irrigation time point in study subjects v. Normal saline irrigation will be used alone in control subjects at the same time points.
15731558|NCT05011929|Behavioral|Cognitive behavioral therapy|refer to the arm description
15731559|NCT05011916|Drug|KDR2-2 suspension eye drops|All patients were instructed to instill one drop four times per day in the study eye for 6 weeks.
15731560|NCT05011903|Behavioral|Cross-tailored Dynamic Feedback|Dynamic, technology-delivered weekly feedback on weekend diary self-reports of first-year college student behavior related to alcohol use and related sexual behaviors.
15731561|NCT05011903|Behavioral|Personalized Feedback Intervention|Technology-delivered personalized feedback on first-year college student behavior related to alcohol use and related sexual behaviors.
15731562|NCT05011890|Device|Moovcare® use|Moovcare® performs symptom monitoring by automatically delivering ePRO surveys on common symptoms experienced by lung cancer patients. Results are stored in a secure web-based portal for provider review. Providers will manage ePRO responses through a combination of reports graphically displaying responses over time and e-mail alerts about concerning levels or combinations of symptoms.
15731563|NCT05011877|Device|High-flow nasal cannula therapy|High-flow nasal cannula therapy (HFNC) (from 25 - 60 L/min based on patient's tolerance) will be used in 21 participants during one additional sleep study to investigate its acute impact on reducing sleep abnormalities. Inspired fraction of oxygen will be titrated to maintain patient SpO2 similar to the levels during standard oxygen therapy.
15731564|NCT05011864|Behavioral|Behavioral Activation|In BA, depressive symptoms are viewed as depressive behaviors. Compared to those without depression, people with depression engage in fewer overt behaviors that provide positive reinforcement and pleasure/enjoyment and in more behaviors that function to escape or avoid aversive stimuli (e.g., staying in bed all day).55-59 Thus, BA is aimed at increasing and reinforcing meaningful, healthy, and enjoyable behaviors while decreasing depressive behaviors and is well-suited to help depressed, disabled older adults increase mood-enhancing activities, self-care management skills, and social connectedness.
15731565|NCT05011864|Behavioral|Fall Prevention|Following FP psychoeducation based on the Centers for Disease Control and Prevention (CDC)'s STEADI tool kits, lay coaches will assist clients in implementing evidence-based FP strategies that have been adapted for low-income homebound seniors. These include referrals to healthcare providers as needed, home safety checks, practice of safe ambulation/transfer and mobility aid use, medication review, and in-home exercise routines with an innovative, gamified tablet-based exercise app for balance and strength building.
15731566|NCT05011864|Other|Telephone support|Subjects in this arm will receive 9 weekly support calls last 30 minutes each. These calls are intended to provide an opportunity for social support and check safety.
15731567|NCT05011851|Drug|NNZ-2591|NNZ-2591 oral solution (50mg/mL) to be administered twice daily at a weight-banded dose for 13 weeks.
15731596|NCT05011682|Behavioral|10-point nutrition plan|controlled portions of low glycemic index carbohydrates, avoidance of rapidly absorbed carbohydrates, adjustment of timing of meals and snacks, and attention to personal and cultural barriers to implementation
15731597|NCT05011669|Drug|Lurasidone|Oral administration with a meal or within 30 min after eating in the evening. The dosage could be adjusted from Day 8.
15736965|NCT04968769|Other|kinesio taping|elastic therapeutic taping
15731568|NCT05011838|Other|1. Health Services Redesign|"1.1. Healthy Hearts service: a nursing station providing blood pressure measurement, cardiovascular risk assessment, preventive counselling and effective follow-up in extended opening hours.
~1.2. Hypertension screening: All adults attending health care facilities who did not have their blood pressure measured in the previous year will be referred to the Healthy Hearts Service for screening.
~1.3. Clinical management: 1.3.1. Creation of the cardiovascular risk team: a group of doctors supervising hypertension management and coordinating improvement.
~1.3.2. Guideline-based standardized diagnostic and treatment protocols: a simplified diagnostic and treatment algorithm will identify a core set of primary and secondary antihypertensive medications.
~1.3.3. Availability of antihypertensive medications: it will be assured through procurement mechanisms and its availability will be communicated to clinicians at the beginning of each week and ad hoc in case of stock-outs."
15731569|NCT05011838|Other|2. Clinical Staff Training|"2.1. Training on good clinical management of hypertension: focused on correct blood pressure measurement, use of evidence-based guidelines, cardiovascular risk assessment, use of a standardized diagnostic and treatment algorithm, correct prescription of pharmacological and non-pharmacological treatment, patient counselling, and how to tackle clinical inertia.
~2.2. Training on communication skills and patients' needs assessment for all health workers involved in hypertension care. This training will be designed under the patient-centred medicine framework, aiming at equipping health providers with tools for understanding patients' feelings and experience of illness, and to improve their capacity to address social, psychological, and behavioural dimensions of hypertension care."
15731570|NCT05011838|Other|3. Patient and Community Engagement|"3.1. Patient empowerment: expert hypertensive patients , under the supervision of a social worker, will provide support and transmit their know-how to other patients in need, particularly those newly diagnosed or non-adherent to treatment or presenting uncontrolled hypertension.
~3.2. Community engagement: a Community Hypertension Outreach Group will be set up, composed of existing voluntary community health workers, who will be trained and certified. This group will conduct blood pressure measurements in selected public areas of the commune, referring those with positive screening to the nearest health facility for diagnosis confirmation. It will also provide health information with emphasis on healthy lifestyles. Existing local communication channels such as the community radio and the local newspaper will be engaged."
15731571|NCT05011825|Behavioral|Pregnant Moms' Empowerment Program|The first session introduces women to the group, seeks to build an alliance and sense of group cohesion, and provides safety planning. The second session addresses intergenerational patterns of violence and how such violence contributes to psychopathology in both the prenatal and postnatal period, focusing on violence prevention. Information regarding cognitive restructuring, behavioral activation, and coping styles is provided in session three, as well as the role of healthy relationships and social supports in promoting resilience. This session begins with discussion on health in pregnancy, labor/delivery, and coordinating care across providers. This session also provides psychoeducation related to post-delivery parenting, including infant safety, care and breastfeeding. In the final session, group leaders assist mothers with identification, sensitivity, and responsiveness to infant cues.
15731572|NCT05011812|Drug|PBI-0451 Dose 1|Dose level 1 of PBI-0451
15731573|NCT05011812|Drug|PBI-0451 Dose 2|Dose level 2 of PBI-0451
15731574|NCT05011812|Drug|PBI-0451 Dose 3|Dose level 3 of PBI-0451
15731575|NCT05011812|Drug|PBI-0451 Dose 4|Dose level 4 of PBI-0451
15731576|NCT05011812|Drug|Ritonavir|Ritonavir will be co-administered with the study drug in Treatments J and K
15731577|NCT05011812|Drug|Midazolam|Midazolam will be co-administered with the study drug in Treatment L
15731578|NCT05011812|Drug|Placebo|Placebo to match
15731579|NCT05011812|Drug|PBI-0451|Dose level of PBI-0451 with a projected exposure
15731580|NCT05011799|Behavioral|Cancer Educational Materials|Receive prostate cancer educational materials
15731581|NCT05011799|Other|Questionnaire Administration|Ancillary studies
15731582|NCT05011799|Other|Educational Intervention|Attend peer-led education sessions
15731583|NCT05011786|Procedure|hernia repair/ligation of the hernial sac|the inguinal hernia sac is ligated using sutures at the level of internal ring throught an inguinal incision in the open group and using laparoscopic instruments in the laparoscopic group
15731584|NCT05011773|Device|Deep brain stimulation|Electrical pulses from implanted generator that has already been implanted for therapeutic reasons
15731585|NCT05011760|Radiation|Baseline [C-11]NPA PET Scan|Radiotracer
15731586|NCT05011760|Drug|d-amphetamine|Oral, 0.5 mg/Kg
15731587|NCT05011760|Radiation|Post-amphetamine [C-11]NPA PET Scan|Radiotracer
15731588|NCT05011747|Procedure|single-site rigid probe viscotrabeculotomy (VT)|single-site VT by the rigid probe trabeculotome is performed through a superonasal triangular scleral flap.
15731589|NCT05011747|Procedure|two-site rigid probe viscotrabeculotomy (VT)|Two-site VT by the rigid probe trabeculotome is performed through a superonasal and an inferotemporal triangular scleral flap.
15731590|NCT05011734|Other|Fast Track recovery pathway|Multidisciplinary approach alongside the orthopedic surgeon
15731591|NCT05011721|Device|Activity tracker|"Participants will receive a Withings Steel HR activity tracker (Withings, Issy-les-Moulineaux, France), which they will be asked to wear 24 hours per day throughout the whole intervention (12 months). At baseline, the Withings Health Mate mobile phone application will be downloaded onto each participant's smartphone or tablet. The clinical research assistant will instruct the participant in the use of the activity tracker. The participant will then accept and activate the sharing of the data collected with the secure server dedicated to the NeoFit study at the Institut Curie. Participants will be asked to synchronize the activity tracker regularly (ideally daily) via Bluetooth with the Withings Health Mate application, for automatic transfer of the data to the secure NeoFit space."
15731592|NCT05011708|Device|I-DROP MGD|I-DROP MGD are eye drop produced by I-MED PHARMA for the management of moderate to severe Dry Eye Disease.
15731593|NCT05011708|Device|Thealoz Duo|I-DROP MGD are eye drop produced by Laboratoires Thea for the management of Dry Eye Disease.
15731594|NCT05011695|Other|physiotherapy|The 1st group will be given ESWT therapy, the 2nd group will be given transverse friction massage, and the 3rd group will be given exercises that are used in the treatment of plantar fasciitis and have proven effectiveness
15731595|NCT05011682|Behavioral|Regular diet|participant's usual diet during 2 weeks
15731655|NCT05011188|Biological|Enzalutamide|Given orally (PO)
15731598|NCT05011656|Device|Seraph-100 + State of the Art Care|Seraph® 100 Microbind® Affinity Blood Filter (Seraph 100) manufactured by ExThera Medical Corporation in Martinez, CA. The Seraph 100 filter has been designed and manufactured to reduce residual risks as much as possible to ensure safe usage. Literature search results concluded that heparin-coated medical devices are safe and decrease platelet adhesion without affecting the adsorption of major adhesive proteins. The efficacy, safety, and risk-benefit data of the studies suggest that Seraph 100 is also safe and potentially beneficial by reducing the rate of thrombosis, without its use entailing a risk for patients. The achieved results from the above-mentioned testing and studies support the performance and safety of Seraph 100 consistent with the intended use. ExThera Medical concludes that the known and potential benefits of Seraph 100, when used to treat patients with pathogen associated shock, outweigh the known and potential risks when used according to the intended use.
15731599|NCT05011656|Device|State of the Art Care|"State of the Art careis defined as the treatment algorithms outlined in the Surviving Sepsis Campaign for the treatment of septic shock, available at https://www.sccm.org/SurvivingSepsisCampaign/Home"
15731600|NCT05011643|Other|Moderate-intensity exercise|Participants will walk either 30km, 40km or 50km for four consecutive days during the Nijmegen Four Days Marches. Measurements will be performed after the finish of the first, second and third walking day.
15731601|NCT05011630|Other|Pancreaticoduodenectomy|The incidece of IAA after pancreaticoduodectomy; to validate the risk factors of IAA
15731602|NCT05011617|Device|Non-intubation and monitoring anesthesia care (MAC)|Non-intubation and monitoring anesthesia care (MAC) consisted of non-intubation technique, local anesthesia at the site of sternotomy, sedation with dexmedetomidine, analgesia with remifentanil/sufentanil, and electroacupuncture.
15731603|NCT05011604|Device|Full-Digital Workflow in Single-Tooth Implant Rehabilitation|"For all patients included in the study, a digital impression was taken using an intraoral scanner. A CBCT exam was performed on the mandibular or maxillary jaw with the missing tooth. The stl. and the dicom. files were then superimposed to allow the surgical planning.
~Then it was elevated and reflected to increase the volume on the buccal side and exposed the bone surface. After this point, the implant was inserted, and another digital impression was taken.
~Sutures 6.0 were positioned after healing abutment positioning to stabilize the soft tissues.
~The final abutment and the provisional were designed and manufactured using cad-cam technology. One week thereafter, definitive abutment was positioned. Provisional restoration was then cemented using provisional cement removing all the possible occlusal contacts both in protrusive and in lateral positions. Three months thereafter, once osteointegration was obtained, definitive zirconia restoration was positioned and cemented."
15731604|NCT05011591|Other|Swimming economy|Detailed in arm's section
15731605|NCT05011578|Radiation|Radiographic assessment|Radiographic assessment after at least 10 years after radiocapitellar surgical treatment
15731606|NCT05011565|Other|Demographic and Clinical Characteristics, Maximal Exercise Capacity, Submaximal Exercise Capacity, Hemodynamic Parameters, Muscle Strength, Muscle Oxygenation, Vascular Function|Demographic and Clinical Characteristics, Maximal Exercise Capacity, Submaximal Exercise Capacity, Hemodynamic Parameters, Muscle Strength, Muscle Oxygenation, Vascular Function
15731607|NCT05011552|Behavioral|Self-Compassion, Health, and Empowerment (SHE)|The SHE intervention includes 8 weekly sessions and 24-hour access to the intervener for any additional support needed. The first and last sessions will be delivered over the phone with the woman based on a brochure. The brochure describes the four major components: a) IPV information, b) Danger Assessment, c) Safety Planning, and d) Resources. It will be discussed with the woman in an interactive manner so that the woman is encouraged to describe her experiences and choose her options as they proceed. Session 2-7 focus on providing mental health self-care resources, which are deep breathing, progressive muscle relaxation, visualization, general introduction and overview of self-compassion, mindfulness, and loving-kindness.
15731608|NCT05011552|Behavioral|The Control Condition|Women randomized to the control group will be provided with the same brochure and mental health care resources.
15731609|NCT05011526|Biological|MVC-COV1901|Approximately 471 participants will receive 2 doses of MVC-COV1901(S-2P protein with adjuvant) at Day 1 and Day 29 via intramuscular (IM) injection in the deltoid region
15731610|NCT05011526|Biological|AZD1222|Approximately 471 participants will receive 2 doses of AZD1222 at Day 1 and Day 29 via intramuscular (IM) injection in the deltoid region
15731611|NCT05011513|Drug|PF-07321332|PF-07321332 (tablet)
15731612|NCT05011513|Drug|Ritonavir|Ritonavir (capsule)
15731613|NCT05011513|Drug|Placebo|Placebo (tablet)
15731614|NCT05011513|Drug|Placebo|Placebo (capsule)
15731615|NCT05011500|Radiation|Radiotherapy with Closed Mask|Radiotherapy for head and neck cancer, using a closed mask (full thermoplastic mask) to restrict patient movement.
15731616|NCT05011500|Radiation|Radiotherapy with Open Mask and Surface Scanning|Radiotherapy for head and neck cancer, using an open mask to restrict patient movement. Surface Scanning is used to monitor patient movement/positioning.
15731617|NCT05011500|Radiation|Radiotherapy with No Mask|Radiotherapy for head and neck cancer, without using a mask to restrict patient movement. Surface Scanning is used to monitor patient movement/positioning.
15731618|NCT05011487|Drug|Osimertinib|80mg/qd oral for 60 days
15731619|NCT05011487|Drug|Cisplatin|Cisplatin (75mg/m2) to be administered with pemetrexed on Day 1 of every 3-week cycle for 2 cycles.
15731620|NCT05011487|Drug|Pemetrexed|Pemetrexed (500 mg/m2) to be administered with cisplatin on Day 1 of every 3-week cycle for 2 cycles
15731621|NCT05011474|Biological|administered an autologous adipose-derived mesenchymal stem cell spheroid pretreated with matrillin 3|Adipose-derived mesenchymal stem cells isolated from subject's adipose tissue are pretreated with matrillin 3 and produced in spheroid form.
15731622|NCT05011461|Other|Almond Oil|Almond Oil Pressed Cold
15731656|NCT05011175|Other|Survey|Participants responded to questions about their exercise habits and perceived levels of intensity as well as demographic information.
15731762|NCT05010265|Other|Semi Structured Interviews|Semi-structured interviews will further serve to identify preferences, expectations and concerns among patients, surrogates, clinicians and researchers surrounding data-sharing of uncertain diagnostic data generated through these investigative neurotechnologies which will then be systematically evaluated.
15731623|NCT05011448|Other|Music Therapeutic Interaction and Verbal Interaction|"In both sessions (the Verbal Interaction and the Music Therapeutic Interaction) participants will be asked to perform three piano playing exercises in a fixed order: (1) playing a musical scale, (2) playing a short excerpt from a familiar song, and (3) free improvisation. Both sessions will also include a protocol of verbal instructions given by the therapist before each exercise. In session A ('Verbal Interaction') participants will perform these exercises alone while the therapist is only interacting with them verbally (asking them questions, commenting regarding their performance etc.). In session B ('Music Therapeutic Interaction') participants will perform these exercises while the therapist is interacting with them musically, using various music therapy techniques that are matched and attuned to each patient's playing dynamics and style. This is to reflect the dynamics of the music therapeutic interaction as it occurs in the real world of music therapy practice."
15731624|NCT05011435|Device|web-application for burnout|Use of burnout advisor web-application for detection of professional burnout
15731625|NCT05011422|Biological|αβ-TCR/CD19 cell depleted haploidentical hematopoietic stem cell graft|Once pheresed, the product will be washed to remove platelets and the cell concentration will be adjusted per laboratory and ClinicMACS technology recommendations. It is then labeled using the CliniMACS αβ-TCR Biotin Kit and CD19+ immunomagnetic microbeads. After labeling, the cells are washed to remove unbound microbeads. The partially processed product is loaded on the CliniMACS device where labeled cells are depleted and the negative fraction is eluted off the device. The negative fraction is centrifuged and volume reconstituted to obtain the final product
15731628|NCT05011383|Drug|High dose testosterone|High dose testosterone is administered subcutaneously once monthly until progression or toxicity
15731631|NCT05011344|Other|Blood sample|Seroneutralization and Elisa tests
15731632|NCT05011331|Device|MedCline Shoulder Relief System|Patients will receive a customized pillow to aid with sleep
15731633|NCT05011318|Other|Baseline|5-min urban park video clip (Presented on a TV)
15731634|NCT05011318|Other|Fatigue Manipulation|20-min 2-back task (Presented on a computer)
15731635|NCT05011305|Drug|Saroglitazar Magnesium 2 mg|Patients randomly assigned to this group will receive Saroglitazar Magnesium 2 mg tablet orally once daily in the morning before breakfast without food, for the duration of treatment (76 weeks).
15731636|NCT05011305|Drug|Saroglitazar Magnesium 4 mg|Patients randomly assigned to this group will receive Saroglitazar Magnesium 4 mg tablet orally once daily in the morning before breakfast without food, for the duration of treatment (76 weeks).
15731637|NCT05011305|Drug|Placebo|Patients randomly assigned to this group will receive Placebo tablet orally once daily in the morning before breakfast without food, for the duration of treatment (76 weeks).
15731638|NCT05011292|Behavioral|Educational Video about SCB|3-4 minutes video about SCB.
15731639|NCT05011292|Behavioral|Survey on child feeding and related knowledge and practices|Short survey about infant feeding practices (3-4 minutes). No identifying information will be collected. The general scope of topics covered in the surveys will be attitudes toward the sugar-containing beverage reduction (SCB) videos played at the clinic as well as SCB knowledge and practices of parents and their children.
15731640|NCT05011292|Behavioral|Educational Video other than SCB|Educational video about a topic other than infant SCB consumption.
15731642|NCT05011266|Drug|Buprenorphine/naloxone|4 mg buprenorphine/1 mg naloxone daily
15731643|NCT05011266|Drug|Placebo|placebo sub-lingual tablet daily
15731644|NCT05011253|Other|Electronic Trigger Microhematuria Alert|To evaluate the effectiveness of an InBasket Results message in prompting providers to place appropriate follow up orders. The message will notify users that a patient has clinically significant microscopic hematuria and is at high risk for underlying malignancy and will include the official recommendations (imaging with a CT urogram, urology evaluation with cystoscopy).
15731645|NCT05011240|Behavioral|Paediatric Autism Communication Therapy (PACT)|PACT is a parent-mediated therapy that aims to improve children's social-communication development. During PACT, a therapist uses video-feedback of parent-child play interactions to coach the parent in how to improve their sensitivity and responsiveness to their child's social-communication and interaction behaviours and to implement evidence-based strategies that facilitate social-communication development.
15731646|NCT05011240|Behavioral|Psychoeducation|Control participants will receive monthly psychoeducation sessions led by a developmental specialist
15731647|NCT05011227|Drug|Camrelizumab|2 cycles before endoscopic surgery and one year after
15731648|NCT05011227|Drug|Chemotherapy|2 cycles before endoscopic surgery, with or without after surgery
15731649|NCT05011227|Procedure|endoscopic surgery|standard endoscopic surgery for recurrent nasopharyngeal carcinoma
15731650|NCT05011214|Drug|Sevoflurane|All patients received 0.1 mg/kg atropine and 1ug/kg dexmedetomidine iv as premedication.
15731651|NCT05011214|Drug|Esketamine|All patients received 0.1 mg/kg atropine and 1ug/kg dexmedetomidine iv as premedication.
15731652|NCT05011201|Device|Dual Joint Visual Feedback without Scoring|Participants will walk on the treadmill while given instantaneous anterior and posterior foot position and immediate scoring information using the DJVF interface. A pediatric physical therapist will provide (1) verbal encouragement and redirection of attention to the task as needed (2) verbal cueing to assist if difficulty in interpreting the feedback and appropriate modification is noted.
15731653|NCT05011201|Device|Dual Joint Visual Feedback with Scoring|Participants will walk on the treadmill using the same DJFB with additional visual cumulative scoring on their performance. A pediatric physical therapist will provide (1) verbal encouragement and redirection of attention to the task as needed (2) verbal cueing to assist if difficulty in interpreting the feedback and appropriate modification is noted.
15731654|NCT05011188|Biological|FOR46|Given intravenously (IV)
15731658|NCT05011149|Drug|Ibuprofen|"Pharmacotherapy, when indicated (ie, for severe PDA on echocardiography, irrespective of clinical symptoms, or a moderate PDA on echocardiography with at least moderate clinical illness), will be provided in the form of ibuprofen as first line agent at a standard dosing of 10 mg/kg followed by 2 doses of 5mg/kg every 24 h. The route of administration may be intravenous or enteral, as determined by the treating team.
~For treated infants, follow-up echocardiography will be conducted at the end of the 3-day course and second course of treatment will be initiated if they still fulfill study treatment criteria as mentioned above. If any treatment-eligible infant has a contraindication to ibuprofen, use of acetaminophen will be permitted as an alternative agent."
15731659|NCT05011136|Other|No intervention. This is a qualitative study|US nephrologists who care for dialysis patients will be asked to complete an internet based survey evaluating the time and effort required for home dialysis patient care.
15731660|NCT05011123|Biological|Yellow fever vaccine (produced on serum-free Vero cells)|Powder and diluent for suspension for injection - Subcutaneous
15731661|NCT05011123|Biological|Yellow fever vaccine|Powder and diluent for suspension for injection - Subcutaneous
15731662|NCT05011110|Device|Graduated compression stockings|Both GraduSOX and Sigvaris are graduated compression stockings. These exert the greatest degree of of compression at the ankle, and the level of compression gradually decreases up the garment.
15731663|NCT05011097|Drug|Y150|Subjects will receive an intravenous infusion of Y150 in a dose escalation once a week for a 28-day treatment cycle until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.
15731664|NCT05011084|Device|Game Ready Cryotherapy with Compression Group|Instead of using the traditional ice-pack cryotherapy (without compression), patients randomized into this group will use the Game Ready device, which uses cryotherapy with compression, during their post-operative treatment care.
15731665|NCT05011084|Other|Control Cryotherapy Group|Patients randomized to the control group will use the standard of care, which is using traditional cryotherapy (i.e., an ice pack without compression)
15731666|NCT05011058|Drug|Nanatinostat in combination with valganciclovir|"Drug: Nanatinostat, 20 mg orally once daily, 4 days per week in 28 day cycles
~Other name: VRx-3996
~Drug: Valganciclovir, 900 mg orally once daily in 28 day cycles"
15731667|NCT05011045|Procedure|Magnetic Resonance Imaging|Undergo MRI
15731668|NCT05011045|Other|Neurocognitive Assessment|Undergo neurocognitive function assessment
15731669|NCT05011045|Other|Quality-of-Life Assessment|Complete questionnaires
15731670|NCT05011045|Other|Questionnaire Administration|Complete questionnaires
15731671|NCT05011032|Diagnostic Test|Homocysteine|It is an amino acid which is synthesized by the demethylation of dietary methionine. It is a highly reactive, Sulfur-containing amino acid as a by-product of metabolism of essential amino acid specifically methionine. It was proved to be a strong risk factor causing many cardiovascular diseases, neurological disturbances and other health related issues
15731672|NCT05011019|Drug|AL2846 capsules|AL2846 is a multi-target receptor tyrosine kinase inhibitor.
15731673|NCT05011006|Diagnostic Test|NT3 blood draw|blood draw
15731677|NCT05010980|Other|CMR|clinical indication
15731678|NCT05010980|Other|scintigraphy|clinical indication
15731679|NCT05010967|Other|High intensity interval training|"HIIT 3 times a week for 8 weeks. For week 1 to 4 , Warm up 5 minutes jogging in place, 6 series of 30 seconds Burpees, 30 seconds recovery, 30 seconds skipping, 30 seconds recovery, 30 seconds lunge, 30 seconds recovery, 30 seconds 1-legged squats, 30 seconds recovery, 30 second leg levers, 30 seconds recovery. the series will have 3 minutes rest in between. Cool down of 10 minutes with gentle stretches.
~For week 5 to 8 , Warm up 5 minutes jogging in place, 6 series of 45 seconds Burpees, 45 seconds recovery, 45 seconds skipping, 30 seconds recovery, 45 seconds lunge, 30 seconds recovery, 45 seconds 1-legged squats, 30 seconds recovery, 45 second leg levers, 30 seconds recovery. the series will have 3 minutes rest in between. Cool down of 10 minutes with gentle stretches."
15731680|NCT05010967|Other|Yoga Training|Yoga 3 times a week for 8 weeks. 30-50 minutes session, 5 minutes breathing, 15-35 minutes yoga poses (Cat-cow, child's pose, downward dog, plank, Cobra), followed by 10 minutes supine meditation.
15731681|NCT05010954|Drug|LXI-15028 50mg group|The investigational products are administrated orally, once in the morning every day, and each dose includes 2 tablets of investigational products (LXI-15028 50mg active agent + Lansoprazole 30mg matching placebo). If the investigational product is not taken in the morning, subjects can take it before 6:00 p.m. on the same day. The duration of treatment is 4 or 6 weeks
15731682|NCT05010954|Drug|Lansoprazole 30mg group|The investigational products are administrated orally, once in the morning every day, and each dose includes 2 tablets of investigational products ( LXI-15028 50mg matching placebo + Lansoprazole 30mg active agent ). If the investigational product is not taken in the morning, subjects can take it before 6:00 p.m. on the same day. The duration of treatment is 4 or 6 weeks.
15731683|NCT05010941|Device|Hypotension Prediction Index|Hypotension Prediction Index monitored via radial arterial line
15731684|NCT05010928|Combination Product|mouthwash with tea|Using tea as a base, supplemented with licorice to make mouthwash to relieve stomatitis.
15731685|NCT05010915|Device|Transcranial magnetic stimulation|Transcranial magnetic stimulation
15731686|NCT05010889|Procedure|Peroral endoscopic myotomy (POEM)|POEM is performed as previously described by Inoue et al (Endoscopy 2010), including four main steps mucosal incision, submucosal tunneling, myotomy and mucosal entry closure.
15731687|NCT05010876|Drug|C1 Inhibitor Human|standard care + 1000 units of C1 inhibitor during 2 slow infusions of 500 units
15731688|NCT05010876|Drug|Icatibant Injection|a single injection of 30 mg subcutaneously
15731689|NCT05010876|Other|Placebo|The placebo will be physiological serum presented in forms mimicking the C1-Inhibitor and the icatibant.
15731690|NCT05010863|Other|Blood collection|The subject will be drawn a 5ml blood sample
15731836|NCT05009784|Other|Short Traffic Sound|Active Comparator: Short Traffic Sound (Played through speakers)
15736966|NCT04968769|Other|exercise|posture exercises
15731691|NCT05010837|Other|Kinesio taping with abdominal exercises|"Experimental group was given kinesio taping along with abdominal exercises. Kinesio taping was applied in I-band technique. the first band is applied on rectus abdominis from origin to insertion starting from pubic symphysis till the xiphoid process. the second band is applied bilaterally on the left and right side external oblique muscles.
~Abdominal exercises consist of 2-3 sets of 8 to 12 repetitions of head lift with bracing, head lift with pelvic tilt, pelvic clock, bridging, knee rolling and deep breathing exercises for 1 to 4 weeks.
~From 5 to 8 weeks Same abdominal exercises with 5 sets and 15 to 20 repetitions were performed along with kinesio taping."
15731692|NCT05010837|Other|Abdominal exercises|"Abdominal exercises consist of 2-3 sets of 8 to 12 repetitions of head lift with bracing, head lift with pelvic tilt, pelvic clock, bridging, knee rolling and deep breathing exercises for 1 to 4 weeks.
~From 5 to 8 weeks Same abdominal exercises with 5 sets and 15 to 20 repetitions were performed."
15731693|NCT05010824|Behavioral|Sleep hygiene practices and behavioural intervention|The first session will involve the provision of sleep-related psycho-education (e.g. sleep hygiene practices) and specific strategies to tackle problematic sleep-related behaviours, as well as collaborative goal setting and development of management plan tailored to the child's sleep problem. The second and third session will involve a review of the sleep diary and a reinforcement of learned strategies, and focus on problem-solving to tackle any issues that have emerged from implementing the behavioural strategies at home. Follow-up phone calls provide parents with an opportunity to ask any further questions and to consolidate learned strategies and further troubleshoot.
15731694|NCT05010785|Procedure|Immediate implant placement and alveolar ridge splitting with GBR and i-PRF|Implant insertion and GBR for augmentation of the gap between buccal and lingual plate using bone graft mixed with i-PRF
15731695|NCT05010785|Procedure|Immediate implant placement and alveolar ridge splitting with GBR|Implant insertion and GBR for augmentation of the gap between buccal and lingual plate
15731696|NCT05010772|Drug|Decitabine and Cedazuridine|Given PO
15731697|NCT05010772|Drug|Enasidenib|Given PO
15731698|NCT05010772|Drug|Gilteritinib|Given PO
15731699|NCT05010772|Drug|Ivosidenib|Given PO
15731700|NCT05010772|Drug|Venetoclax|Given PO
15731701|NCT05010759|Device|NanoTherm Ablation|Iron nanoparticles are instilled into the prostate cancer lesion and then the particles are heated using a magnetic field and this heating ablates the prostate cancer lesion.
15731702|NCT05010746|Device|Innovalve TMVR system|Innovalve TMVR system
15731703|NCT05010733|Device|Total hip arthroplasty using the Exeter V40 cemented femoral stem|Consists of applying a cement layer of at least 2 millimeters surrounding an undersized prosthetic stem, so that this layer of cement fits between the femoral medullary canal and the prosthetic's femoral stem.
15731704|NCT05010733|Device|Total hip arthroplasty using the Müller Straight Stem|Consists of applying a thin layer of cement, so that the prosthetic's femoral stem fills as much as possible the femoral medullary canal.
15731705|NCT05010707|Drug|Transdermal patch|Participants will be prescribed the medication and dosed based on their hormonal profile. Goal is achieve estradiol level between 100-200 pg/mL and to suppress testosterone to cisgender female levels
15731706|NCT05010707|Diagnostic Test|Pro-thrombotic markers|Once participants are started on gender affirming hormone therapy, pro-thombotic markers will be checked at baseline and every 6 months. Pro-thrombotic markers will include: Factor II, Factor IX, Factor XI, Von Willebrand factor, Protein C, Protein S, activated Protein C resistance.
15731707|NCT05010707|Diagnostic Test|Metabolic markers|Once participants are started on gender affirming hormone therapy, metabolic markers will be checked at baseline and every 6 months. Markers will include: Insulin level, fasting glucose, body mass index, waist circumference.
15731708|NCT05010707|Diagnostic Test|Hormone Profile|Once participants are started on gender affirming hormone therapy, hormonal levels will be checked every 4 weeks until estradiol and testosterone levels are within goal as established by standard of care.
15731709|NCT05010707|Drug|Sublingual Tablet|Participants will be prescribed the medication and dosed based on their hormonal profile. Participants will take dose as once daily medication. Goal is achieve estradiol level between 100-200 pg/mL and to suppress testosterone to cisgender female levels
15731710|NCT05010707|Drug|Sublingual Tablet|Participants will be prescribed the medication and dosed based on their hormonal profile. Participants will take dose as twice daily medication. Goal is achieve estradiol level between 100-200 pg/mL and to suppress testosterone to cisgender female levels
15731711|NCT05010707|Drug|Spironolactone|All patients will also receive spironolactone. Spironolactone will be started at 50 mg daily and will increase to standard dose.
15731712|NCT05010694|Drug|GH35 Tablet|GH35 for oral administration at doses of Dose A, Dose B, Dose C, Dose D, Dose E and Dose F.
15731713|NCT05010681|Drug|Sintilimab|Sintilimab will be administered at 200 mg i.v. every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
15731714|NCT05010681|Drug|Lenvatinib|Lenvatinib will be administered (bodyweight ≥ 60 kg, 12 mg; < 60 kg, 8 mg) orally daily every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
15731715|NCT05010668|Drug|cryoablation|Cryoablation treatment starts at day 0.
15731716|NCT05010668|Drug|Sintilimab|Sintilimab plus a bevacizumab biosimilar will be initiated on day 14 after cryoablation. Sintilimab will be administered at 200 mg i.v. every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
15731717|NCT05010668|Drug|lenvatinib|Lenvatinib will be initiated on day 14 after cryoablation. Lenvatinib will be administered (bodyweight ≥ 60 kg, 12 mg; < 60 kg, 8 mg) orally daily every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
15731718|NCT05010655|Device|Use of Eko DUO Electronic Stethoscope|Auscultation of heart sounds using electronic stethoscope
15731719|NCT05010642|Device|Use of Eko DUO electronic Stethoscope|Auscultation of heart sounds using electronic stethoscope
15731758|NCT05010291|Behavioral|Social norms framed text message reminder to attend clinic appointment|Social norms framed one-way text message reminding recipient of care to either 1) attend a scheduled clinic appointment or 2) visit the clinic after a missed appointment.
15731722|NCT05010616|Device|Fixed orthodontic appliances|"Visual presentation of patient's predicted teeth alignment at the end of orthodontic treatment:
~Presenting predicted teeth alignment after orthodontic treatment to patients before treatment starts, by using photos and videos of dental digital set-up.
~Predicted teeth alignment can be described as: well-leveled and aligned patient's dental arches, well engaged posterior teeth and normal frontal teeth relationships."
15731723|NCT05010603|Genetic|Blood Draw|Collection of blood samples for genetic testing
15731724|NCT05010603|Other|Late Onset Alzheimer's Disease (LOAD) Neuropsychological Battery Test|Memory Test
15731725|NCT05010590|Drug|Romosozumab|Monthly romosozumab
15731726|NCT05010590|Drug|Denosumab|Every 6 months denosumab
15731727|NCT05010577|Drug|BX004-A|Combination of nebulized bacteriophages targeting Pseudomonas aeruginosa
15731728|NCT05010577|Drug|Placebo|Nebulized placebo
15731729|NCT05010564|Genetic|Autologous TriCAR T-cells and lymphodepletion chemotherapy|"Three dose levels will be evaluated with the opportunity to dose de-escalate (dose level -1) for toxicity.
~DL-1: 3x10^6 cells/m2
~DL1: 1×10^7 cells/m2
~DL2: 3×10^7 cells/m2
~DL3: 1×10^8 cells/m2
~Lymphodepletion chemotherapy consisting of Fludarabine 30 mg/m2 IV once daily x 4 doses; and Cyclophosphamide 500mg/m2 IV once daily x 2 doses (starting with the first dose of fludarabine)must be completed greater than or equal to 48 hours prior to infusion of CAR-T cells.
~The protocol will allow for up to three additional infusions of the CAR-T product for subjects who meet criteria for retreatment."
15731730|NCT05010538|Drug|Sarecycline|60 mg sarecycline tablets will be given for subjects with a body weight of 33 to 54 kg, 100 mg sarecycline tablets will be given for subjects with a body weight of 55 to 84 kg, and 150 mg tablets will be given for subjects with a body weight between 85 and 136 kg.
15731731|NCT05010525|Drug|ATG-016|48 patients enrolled, orally, each 3 week (21-day) a cycle
15731734|NCT05010499|Drug|Levobupivacaine|femoral nerve block receives 20 ml of levobupivacaine 0.25%
15731735|NCT05010499|Drug|Levobupivacaine|Fascia iliaca block receives 40 ml of levobupivacaine 0.25%
15731736|NCT05010486|Procedure|rectal surgery|
15731737|NCT05010473|Behavioral|Speech and non-speech sound stimulation|Listening to repetitive and extended sound presentation induces specific neural and physiological activity that we will measure via electroencephalography and pupillometry
15731738|NCT05010460|Drug|Roxadustat|orally 100mg every other day for 5-8 days prior to CABG
15731739|NCT05010460|Drug|Placebo|orally 100mg every other day for 5-8 days prior to CABG
15731740|NCT05010447|Device|Virtual Coach App|The avatar-guided app aims to deepen the user's understanding of Acceptance and Commitment Therapy (ACT) and promote application of ACT skills in every-day-life. Event-Sampling-Methodology (ESM) is used to capture the user's progress as it unfolds.
15731741|NCT05010434|Drug|Sintilimab and Bevacizumab Combined with Radiotherapy|Before radiotherapy: Bevacizumab+Sintilizumab, Q3w, 2 cycles in total. Radiation therapy: 30-50Gy/10 fractions. After radiotherapy: Bevacizumab+Sintilizumab, Q3w until disease progression or toxicity is intolerable.
15731744|NCT05010408|Other|Flavored carbonated soft drink (CSD) at different sweetness levels|Beverage
15731745|NCT05010395|Behavioral|Letter intervention|Letter intervention
15731746|NCT05010382|Procedure|Implant placement surgery|Under local anaesthesia, full-thickness mucoperiosteal flaps were elevated, the alveolar ridge measured, and a proper implant dimension (3.75 mm and 4.25 mm diameter; 8 mm, 10 mm and 11.5 mm length) and position selected. After site preparation, each patient was randomly allocated to the test or the control group. Patients in the test group received a modified implant design with the coronal third presenting a machined surface (hybrid surface (HS) group), while in the control group the same implant design with a titanium rough surface up to the implant shoulder was used (rough surface (RS) group). Implants were placed 1 mm sub-crestally. In the case of dehiscence or fenestrations around the implant, the patient was excluded from the study. Once inserted, healing abutments (ranging between 3 -5 mm) were placed, and flaps sutured around the abutments to allow for a transmucosal healing.
15731747|NCT05010369|Diagnostic Test|spectroscopic measurement|measurement of the tissue with spectroscopy
15731748|NCT05010369|Diagnostic Test|FNA biopsy|a fine needle aspiration (FNA) biopsy will be taken
15731749|NCT05010369|Diagnostic Test|histopathology and cytology|Histopathology and cytology will be performed on the samples
15731750|NCT05010356|Drug|Insulin|Hyperinsulinemic euglycemic clamp
15731751|NCT05010343|Radiation|carbon ion irradation|All patients will receive carbon ion irradiation with 65.6 GyE in 16 fractions to the prostate with or without seminal vesicle
15731752|NCT05010343|Radiation|Carbon Ion Irradiation With SIB|All patients will receive carbon ion irradiation with 65.6 GyE in 16 fractions to the prostate with or without seminal vesicle, and with simultaneous integrated boost (SIB) to the gross tumor in the PSMA PET/CT and mpMRI
15731753|NCT05010317|Behavioral|Mindfulness and acceptance based therapy|This is a six session behavioral intervention that is aimed at building psychological flexibility among adolescents. It involves careful use of language, metaphors, experiential learning and mindfulness to develop skills that support values guided living. Participants learn to relate with their inner thoughts, feelings and urges in an open and elaborative way as conscious human beings and make choices that improve their lives even in the presence of such difficult experiences.
15731754|NCT05010317|Behavioral|Standard of care|Usual clinic based counselling offered as routine care to adolescents
15731756|NCT05010291|Behavioral|Standard of Care (SOC) text message reminder to attend clinic appointment|SOC one-way text message reminding recipient of care to either 1) attend a scheduled clinic appointment or 2) visit the clinic after a missed appointment.
15731757|NCT05010291|Behavioral|Loss aversion framed text message reminder to attend clinic appointment|Loss aversion framed one-way text message reminding recipient of care to either 1) attend a scheduled clinic appointment or 2) visit the clinic after a missed appointment.
15731763|NCT05010252|Behavioral|Cycled light Experimental|The preliminary plan of this study is to carry out empirical evidence and expert advice to confirm precise lighting and develop care intervention strategies for preterm infants based on evidence. It is planned to be in the Neonatal Intermediate Care Nursery, National Taiwan University Children's Hospital, and the subjects are premature babies born 32 weeks old. Divided into two groups of light intervention group and control group, longitudinal tracking intervention effect and six-weeks and three-months delay effect.
15731764|NCT05010239|Other|30-minute Mindfulness-Based Supportive Therapy|The MBST consists of a session that involves interviewing patients with open-ended questions on suffering experiences. During the session, the practitioner will practice mindful breathing simultaneously while listening to patients. The practitioner will acknowledge the distress of patients when it is appropriate, but without losing their attention on mindful breathing.
15731765|NCT05010239|Other|30-minute supportive listening|Patients in the control group will receive a 30-minute supportive listening session by a palliative care physician who has no experience in mindfulness practice. The session involves interviewing patients with the same open-ended questions on suffering experiences. The practitioner will acknowledge the distress of patients when it is appropriate. Outcomes will be measured at baseline and at minute 30.
15731766|NCT05010213|Other|Educational intervention|Educational intervention
15731767|NCT05010200|Biological|PGV-001|personalized genomic peptide vaccine
15731768|NCT05010200|Biological|Poly-ICLC|immune modulator
15731769|NCT05010200|Biological|CDX-301|soluble recombinant human protein to work on stem cell
15731770|NCT05010187|Behavioral|Behavioral: Motivational Interview (MI)|Single-session, brief motivational interview.
15731771|NCT05010187|Behavioral|Behavioral: Health Coaching (HC)|Single-session health coaching.
15731772|NCT05010148|Drug|Lidocaine IV|Intravenous lidocaine will be given at 1.33mg/kg/hr (adjusted body weight) for 48 hours following major spinal surgery
15731773|NCT05010148|Drug|Placebo|D5 water given at an equivalent ml/hr as intravenous lidocaine (treatment arm) for 48 hours following major spinal surgery
15731774|NCT05010135|Device|Zebris Gait System assessment for gait weight distribution + EMG evaluation of Quadriceps, Hamstrings, Tib Anterior and Calves + Positional Sense assessment|To measure the above parameters and to compare between the healthy subjects and the vertebral fracture subjects
15731775|NCT05010122|Drug|Decitabine and Cedazuridine|Given PO
15731776|NCT05010122|Drug|Gilteritinib|Given PO
15731777|NCT05010122|Drug|Venetoclax|Given PO
15731778|NCT05010109|Other|6 Minute Walk Functional Test|Participate in 6 MWT
15731779|NCT05010109|Procedure|Biospecimen Collection|Undergo blood and urine sample collection
15731780|NCT05010109|Procedure|Computed Tomography|Undergo SPECT/CT
15731781|NCT05010109|Procedure|Echocardiography|Undergo echocardiogram
15731782|NCT05010109|Procedure|Exercise Cardiac Stress Test|Undergo stress test
15731783|NCT05010109|Other|Questionnaire Administration|Complete questionnaires
15731784|NCT05010109|Procedure|Single Photon Emission Computed Tomography|Undergo SPECT/CT
15731785|NCT05010096|Drug|Copanlisib|Given IV
15731786|NCT05010096|Drug|Elimusertib|Given PO
15731787|NCT05010083|Behavioral|diet and lifestyle program|See description of main arm.
15731788|NCT05010070|Behavioral|diet and lifestyle program|See description of main arm.
15731789|NCT05010057|Dietary Supplement|New Zealand blackcurrants (NZBC)|NZBC capsules containing anthocyanin-rich blackcurrant extract
15731790|NCT05010057|Dietary Supplement|Placebo (PLA)|Placebo capsules containing microcrystalline cellulose
15731791|NCT05010044|Behavioral|mindfulness-based cognitive therapy (MBCT)|Mindfulness- Based Cognitive Therapy (MBCT) It involves practicing to be present 'in the moment' and an attitude of non- judgmental acceptance with the aim to maintain awareness, disengaging oneself from strong attachment and thereby developing a greater sense of emotional balance and well-being.
15731792|NCT05010044|Other|Antipsoriatic treatment|The routine drug therapy for psoriasis.
15731793|NCT05010031|Radiation|Palliative radiotherapy|The first cohort of 26 evaluable patients will be treated with 4Gyx2, followed by a 6 month observation period post-RT to assess for treatment failures. If 7 or more failures are observed, cohort 1 will be closed and 4Gyx3 will be explored in the second cohort. If at most 6 failures are detected in the first cohort, dose will be further reduced to 4Gyx1 for the second cohort. Radiation therapy will be delivered according to department standards, including normal tissue constraints per hypofractionated guidelines. All techniques including conventional, 3D-CRT, or IMRT technique may be used. Image guidance at the time of treatment delivery to verify patient positioning may be chosen at the discretion of the treating radiation oncologist according to department standards.
15731794|NCT05010018|Behavioral|Web-based application connecting small food store owners and suppliers of healthier foods and beverages|The primary intervention is a web-based app that connects small food store owners in low income Baltimore with suppliers of healthier foods and beverages. To reduce costs associated with small purchasing quantities by corner stores, and high delivery charges, the BUD app uses collective purchasing and shared delivery strategies. BUD will be implemented in four stages, where each stage promotes different food/beverage items and introduces new features. The app will be bundled with a small subsidy in stages 1-2 to encourage initial use, increase familiarity with the app and reduce risk. Trainings in the use of the app will take place at the beginning of each phase. BUD will use collective purchasing at stage 2 of implementation (BuddyUp!). The BuddyLift! feature will start in stage 3, enabling small store owners to deliver BuddyUp! deals to other stores for an additional discount. Participating stores and wholesalers will receive point of purchase materials to promote BUD products.
15731795|NCT05010005|Drug|Ruxolitinib|Ruxolitinib 20mg BID
15731796|NCT05010005|Drug|Duvelisib|Duvelisib 25mg, 50mg, or 75mg BID
15731837|NCT05009784|Other|Medium Traffic Sound|Active Comparator: Medium Traffic Sound (Played through speakers)
15731838|NCT05009784|Other|Long Traffic Sound|Active Comparator: Long Traffic Sound (Played through speakers)
15731839|NCT05009784|Other|Short Traffic and Bird Sound|Experimental: Short Traffic and Bird Sound (Played through speakers)
15731806|NCT05009953|Drug|Irinotecan Liposome Injection|Irinotecan Liposome Injection, intravenously, over 90 min on days 1 of every 14-day cycle, 43mg/10mL
15731807|NCT05009953|Drug|SG001|Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection, intravenously, over 60 min on days 1 of every 14-day cycle, 100mg/10mL
15731808|NCT05009953|Drug|Fluorouracil|5-Fluorouracil (5-Fu), intravenously, over 46 h on days 1 of every 14-day cycle
15731809|NCT05009953|Drug|Leucovorin|Leucovorin (LV), intravenously, over 30 min on days 1 of every 14-day cycle
15731810|NCT05009940|Device|Graduated compression stockings|Both GraduSOX and Sigvaris are graduated compression stockings. These exert the greatest degree of of compression at the ankle, and the level of compression gradually decreases up the garment.
15731811|NCT05009927|Drug|Imatinib tablets|Imatinib interruption
15731812|NCT05009914|Procedure|cardiac denervation|Excision of Marshall ligament and Waterstone fat pad during CABG.
15731813|NCT05009901|Drug|Alpha Lipoic Acid 600 MG Oral Tablet|Alpha lipoic acid 600 mg daily for 8 weeks
15731814|NCT05009901|Drug|Placebo|Placebo one tablet daily for 8 weeks
15731815|NCT05009875|Other|Medical Food SBD111|One capsule administered twice daily with morning and evening meals for 52 weeks
15731816|NCT05009875|Other|Placebo|One capsule administered twice daily with morning and evening meals for 52 weeks
15731817|NCT05009862|Drug|Rivaroxaban 2.5 Mg Oral Tablet|rivaroxaban 2.5 milligrams twice daily
15731818|NCT05009862|Drug|Placebo|placebo
15731819|NCT05009862|Drug|Aspirin 81Mg Ec Tab|aspirin 81 milligrams
15731820|NCT05009849|Other|Yoga Exercises|The exercises in the Exercise I arm (Yoga and conventional exercises) will be upgraded to Phase II. Patients will be allowed to attend a minimum of four out of seven days in Phase I and II. Patients will be assessed at 6-9 months for compliance to phase II exercises. Only if patients are fulfilling the criteria for accuracy, sequence and duration of phase II exercises, will they be taught phase III exercises. Patients who are unable to do phase II exercises accurately or demonstrate non compliance to the exercise routine at first follow up visit/ 6-9 months will be re taught phase II exercises. These patients will be upgraded to phase III only if able to perform phase II adequately at assessment. Six months after completion of phase III exercises, patients will be assessed for compliance to phase III exercises. These women's will be assessed at the subsequent 6-9 month follow up and compliance will be evaluated.
15731821|NCT05009836|Drug|Savolitinib|Subjects will receive Savolitinib orally once per day (QD) + Osimertinib orally QD,21day cycles (every 3 weeks) until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
15731822|NCT05009836|Drug|Placebo|Subjects will receive placebo orally once per day (QD) + Osimertinib orally QD,21day cycles (every 3 weeks) until disease progression, death, adverse
15731823|NCT05009823|Dietary Supplement|Standard F75|F-75 contains 75 kcal and 0.9 g protein per 100 ml.
15731824|NCT05009823|Dietary Supplement|Alternative F75 With CMV|Cereal flour, oil, sugar, powdered milk with complex mineral-vitamin.
15731825|NCT05009823|Dietary Supplement|Alternative F75 Without CMV|Cereal flour, oil, sugar, powdered milk without complex mineral-vitamin.
15731826|NCT05009823|Dietary Supplement|F100|100 kcal and 3 g protein per 100 ml if the test of appetite at the end of the stabilization phase is negative (the child does not accept the Plumpynut)
15731827|NCT05009823|Dietary Supplement|Standard F75 + RUTF|Standard F75 with ready to-use therapeutic food (Plumpynut) if the test of appetite at the end of the stabilization phase is positive
15731828|NCT05009823|Dietary Supplement|Alternative F75 with CMV + RUTF|Alternative F75 + CMV with ready to-use therapeutic food (Plumpynut) if the test of appetite at the end of the stabilization phase is positive and the child received Alternative F75 + CMV during the stabilization phase
15731829|NCT05009823|Dietary Supplement|Alternative F75 without CMV + RUTF|Alternative F75 - CMV with ready to-use therapeutic food (Plumpynut) if the test of appetite at the end of the stabilization phase is positive and the child received Alternative F75 - CMV during the stabilization phase
15731830|NCT05009810|Dietary Supplement|astaxanthin 4 mg|They will take astaxanthin 4 mg 1 capsule once daily for 2 months.
15731831|NCT05009810|Dietary Supplement|astaxanthin 6 mg|They will take astaxanthin 6 mg 1 capsule once daily for 2 months.
15731832|NCT05009810|Dietary Supplement|Placebo|They will take placebo 1 capsule once daily for 2 months.
15731833|NCT05009797|Procedure|atrial fibrillation catheter ablation|The ablation is performed under local anesthesia or general anesthesia. A transseptal puncture will be performed to access the left atrium. Pulmonary vein isolation will be performed as a first step. Additional lesions will be made at the discretion of the operators. Patients will receive anticoagulation for at least 3 months after the ablation. Treatment thereafter will be extended at the discretion of the treating physician.
15731834|NCT05009784|Other|Baseline|5-min urban park video clip (Presented on a TV)
15731835|NCT05009784|Other|Fatigue Manipulation|20-min 2-back task (Presented on a computer)
15741429|NCT04930653|Biological|Mogamulizumab|Given IV
15731845|NCT05009771|Drug|Intravenous patient-control analgesia|At the two trial sites, IV-PCA is commonly used with morphine. The device is installed after delivery and removed within 3 days.
15731846|NCT05009771|Drug|Dinalbuphine sebacate|Dinalbuphine sebacate is a prodrug of nalbuphine. With oil-based formulation, the active ingredient releases slowly and the effect lasts longer than nalbuphine. After delivery, a single 150 mg dose of dinalbuphine sebacate is administered intramuscularly.
15731847|NCT05009758|Procedure|Blood sampling|Blood collection for PBMC isolation, measurement of cytokines in serum, and mass cytometry
15731848|NCT05009758|Procedure|Nasosorption|Nasosorptions will be applied for the collection of nasal secretions (Nasosorption FX-I, Hunt Developments (UK) Limited, Midhurst, West Sussex, United Kingdom). Under visualization, the device will be inserted into the nasal cavity and be placed along the lateral wall against the inferior turbinate. The index finger of the patient will be used to press onto the external aspects of the alar and lateral nasal cartilages to hold the device in place. After 1 minute, the devices will be removed.
15731849|NCT05009758|Procedure|Oral sampling|For oral sampling, saliva collection devices (SuperSAL or PureSAL, Oasis Diagnostic Corporation, USA) will be applied followed by elution. Then swabs optimized for the collection of specimens will be applied (CLASSIQSwabs, Copan Diagnostics Inc. Murietta, CA, USA) to the dorsum of the tongue.
15731850|NCT05009758|Procedure|Bronchoscopy|The bronchoscopy will be performed in the outpatient clinic of the Department of Pulmonology. Bronchial alveolar lavage (BAL): the bronchoscope is wedged in the segmental or subsegmental bronchus of the middle lobe. Up to 300 ml sterile normal saline is injected stepwise via handheld syringe and then gradually withdrawn back into the syringe. BAL fluid (BALF) will be prepared and further analyzed in the lab. Transbronchial biopsy (TBLB): performed by forceps in the lung periphery under fluoroscopy guidance. Up to 4 biopsies are taken in two different lobes of one lung with a distance of 1-2 cm to the pleura. TBLB is only performed in patients who have got not contraindications.
15731851|NCT05009758|Procedure|Nasal biopsy|Nasal biopsies will be taken during routine endoscopy performed to score CRSwNP. Patients will receive local anesthesia and decongestants prior to obtaining the biopsy. Samples will either be embedded in OCT or processed for cellular analysis
15731852|NCT05009758|Procedure|Nasal sampling|Swabs optimized for the collection of specimens will be applied (CLASSIQSwabs, Copan Diagnostics Inc. Murietta, CA, USA) to the anterior naris and middle meatus of each nostril
15731853|NCT05009758|Procedure|Nasal mucosa mRNA sampling|Mucosal mRNA sampling will be performed using a 10cm nasal curette (either Rhino-Probe, Arlington Scientific, USA or Cellskim, Hunt Developments, UK). Under direct visualization, the curette will be brought to lie against the mid-inferior portion of the inferior turbinate. The curette will be pressed against the mucosal surface moved outwards 2-3 times. This motion will be repeated 2-3 times to ensure good sample collection. This curette and technique have been shown to cause no significant discomfort to patients and thus it has the advantage of no requirement for local anesthetics.
15731854|NCT05009758|Diagnostic Test|Pregnancy test|In female patients, pregnancy will be excluded with a standard urine pregnancy test at the beginning of the main visit.
15731855|NCT05009758|Other|Medical history of patients, demographic data, concomitant medication, questionnaire|Patients will be asked for their medical history including demographic data and concomitant medication. Details will be noted in the source data file. Furthermore, patients will receive a questionnaire including tools to assess QOL impairment by CRS and asthma
15731856|NCT05009758|Diagnostic Test|UPSIT smell test|University of Pennsylvania Smell Identification Test (UPSIT) smell test will be performed by the patients during the study. It consists of 40 questions in 4 different booklets. The patient needs to scratch a sniff strip with the microencapsulated odorant using a pencil and mark his choice on four-choice multiple-choice questions. The test is then scored by the study team out of the 40 items.
15731857|NCT05009758|Procedure|Spirometry|Lung function will be measured by spirometry in the lung function unit of the Department of Pulmonology. Spirometry will be performed according to American Thoracic Society/European Respiratory Society (ATS/ERS) guidelines by authorized and properly certified personal.
15731858|NCT05009758|Procedure|FeNO|Airway inflammation will be evaluated using a standardized single-breath FeNO test in accordance with the lung function unit of the Department of Pulmonology. A single exhalation technique recommended by the manufacturer will be followed. The FeNO measurements will not be performed within 2 weeks of a respiratory infection. The FeNO test will be performed prior to spirometry. Subjects should not eat or drink 1 hour prior to having the FeNO test. Subjects should not use their rescue SABA medication (e.g., albuterol/salbutamol) within 6 hours of the measurement. Inhaled bronchodilators (including ICS/LABA) should be withheld for the effect duration specific to the bronchodilator. If not, the assessment should be postponed till after the required time has passed since the meal or drink or bronchodilator inhalation. The NIOX VERO® Airway Inflammation Monitor will be used to measured FeNO in the lung function unit of the Department of Pulmonology.
15731859|NCT05009758|Procedure|Lung X-Ray|After the bronchoscopy, a lung x-ray will be performed and patients will stay overnight in the ward of the Department of Pulmonology.
15731860|NCT05009745|Procedure|PGT-A Strategy|PGT-A strategy involves trophectoderm biopsy, comprehensive chromosome screening (CCS) using Next Generation Screening (NGS), freezing of embryos and replacement in a frozen-thawed embryo transfer cycle.
15731861|NCT05009732|Drug|GT0918|300mg once daily orally for 14 days or until discharge per investigators' discretion whichever occurs later
15731862|NCT05009732|Drug|Standard of care|Local standard of care per written policies or guidelines
15731863|NCT05009732|Drug|Matching placebo|Matching placebo
15731864|NCT05009719|Biological|Prophylactic Donor lymphocytes infusions|"Donor lymphocytes is taken by apheresis or dose of blood from allogeneic donor. After apheresis lymphocytes arel freezed for next using. DLI is transfused to patients IV using central venous access.
~Donor lymphocytes infusion start from D+60 - D+100 and continue with escalating doses every 1.5-3 months during first year after HSCT up to appearance of GVHD or signs of disease. First dose is 1*10*6 CD3+/kg. Subsequent doses increases by 0.5 log for haploidentical and unrelated donor and 1 log for sibling donor up to 1*10*8 CD3+/kg."
15731896|NCT05009498|Other|Placebo|Placebo capsule, identical in appearance to the Vitamin D3 supplement capsule Dosing intervals identical in duration and quantity as Vitamin D3 supplement group
15731913|NCT05009394|Procedure|Standard neuroma treatment, neuroma excision and muscle burying|Surgical procedure without any nerve reconstruction, where the injured nerve is buried in an adjacent deep muscle.
15731865|NCT05009719|Biological|Preventive Donor lymphocytes infusions|"Donor lymphocytes is taken by apheresis or dose of blood from allogeneic donor. After apheresis lymphocytes freeze for next using. DLI are transfused to patients IV using central venous access.
~Donor lymphocytes infusion continue with escalating doses every 1.5-3 months up to achieving MRD negative status or appearance of GVHD or signs of active disease.
~First dose is 1*10*6 CD3+/kg for patients without previous GVHD and 1*10*5 CD3+/kg for patients with previous GVHD. Subsequent doses increases by 0.5 log for haploidentical and unrelated donor and 1 log for sibling donor up to 1*10*8 CD3+/kg."
15731866|NCT05009706|Other|Self-care in Older frail Persons with Heart failure Intervention (SOPHI)|Patients who are randomized to the Self Care group will receive oral and written information, advice and support on following activities: excercise (from physiotherapist), nutrition (dietician) and symptom management (nurse), based on patient´s individual needs and abilities. The Self Care group will perform the activities daily at home. Once a week, patients come to the hospital to exercise with the support of a physiotherapist. Once a week or every other week patients will meet (at hospital or by phone) the dietician and nurse to solve possible problems and to follow-up food/nutrition intake and symptoms/symptom management.
15731867|NCT05009693|Other|White Light Application|White Light Therapy
15731868|NCT05009680|Drug|GB1211|GB1211 is a galectin-3 inhibitor an orally available small molecule anti-fibrotic. It is administered orally twice a day
15731869|NCT05009680|Drug|Placebo|Placebo is administered orally twice a day
15731870|NCT05009667|Device|Angiography-derived Index of Microcirculatory Resistance|"caIMR will be measured by pressure sensors which are produced by Suzhou Rainmed Medical Technology Co., Ltd.
~caIMR is calculated based on angiography images and Hyperemic Pa estimated from resting Pa according to prespecified equation."
15731871|NCT05009667|Device|Pressure wire-based Index of Microcirculatory Resistance|"IMR will be measured by thermodilution method with pressure wire and arterial physiological detector which are produced by St. Jude Medical.
~IMR = Pd ∙Tmn"
15731872|NCT05009654|Dietary Supplement|L-carnitine|
15731873|NCT05009654|Dietary Supplement|L-leucine|
15731874|NCT05009641|Dietary Supplement|L-carnitine|
15731875|NCT05009628|Procedure|automated oxygenation with a sitting patient position in the ICU|Oxygenation will be done with the Free O2 device via oxygen goggles or a face mask and with an O2 prescription to obtain a SpO2> 94%. The patient's position in the ICU will be a sitting position with the chest raised at an angle greater than 45°.
15731876|NCT05009628|Procedure|Automated oxygenation with the patient lying down in the ICU|Oxygenation will be done with the Free O2 device via oxygen goggles or a face mask and with an O2 prescription to obtain a SpO2> 94%. The patient's position in the ICU will be a recumbent position with the head elevated to a maximum of 10
15731877|NCT05009628|Procedure|Oxygenation is controlled with the patient in a sitting position in the ICU.|ICU. Oxygenation will be done via the same interface in manual mode where the post-interventional monitoring room nurse modifies the flow to maintain oxygen saturation above 94%. The patient's position in the ICU will be a sitting position with the chest raised at an angle greater than 45°.
15731878|NCT05009615|Dietary Supplement|Green coffee extract|150 mg polyphenols from green coffee, twice daily
15731879|NCT05009615|Dietary Supplement|Beta glucan|2.5 g BG twice daily
15731880|NCT05009615|Dietary Supplement|Green coffee + beta-glucan|150 mg polyphenols from green coffee + 2.5 g BG, twice daily
15731881|NCT05009602|Diagnostic Test|Toe Brachial Pressure Index (TBPI)|TBPI will be measured using the photoplethysmography (PPG) method, employing an infrared sensor placed on the hallux and index finger.
15731882|NCT05009602|Diagnostic Test|Ankle Brachial Pressure Index (ABPI)|A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery.
15731883|NCT05009602|Diagnostic Test|Exercise Ankle Brachial Pressure Index (ABPI)|A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the dorsalis pedis and posterior tibial artery, following the participant completing 50 consecutive repetitions of active dorsiflexion whilst standing.
15731884|NCT05009602|Diagnostic Test|Audible handheld Doppler|Audible CW Doppler interrogation of the dorsalis pedis and posterior tibial artery.
15731885|NCT05009602|Diagnostic Test|Visual handheld Doppler|Visual CW interrogation of the dorsalis pedis and posterior tibial artery was performed using the handheld Huntleigh Digital Dopplex device.
15731886|NCT05009602|Diagnostic Test|Podiatry Ankle Duplex scan (PAD-scan)|"Podiatry ankle duplex scan (PAD-scan) involves using an ultrasound machine to visualise the anterior and posterior tibial arteries at the ankle.
~To be used in 4 participating centers only."
15731887|NCT05009576|Other|silver alginate|silver alginate hydrofiber dressing
15731888|NCT05009576|Other|VAC dressing without silver alginate|vaccum assisted dressing
15731889|NCT05009563|Radiation|FDG-PET/CT|whole-body F-18-fluoro-deoxy-glucose positron emission tomography/computed tomography
15731890|NCT05009550|Procedure|Group ESP|Single-shot ultrasound guided ESP block is performed at the T8 vertebral level before the procedure to all patients in ESP block Group
15731891|NCT05009550|Other|Non-blocked Group|This Group is received no intervention.Patients will be sedated as standard and radiofrequency procedure will be applied.
15731892|NCT05009524|Device|iPACES (interactive Physical and Cognitive Exercise System)|"iPACES involves a pedal-to-play neuro-exergame in which physical and mental exercise are combined in an interactive way. In this condition a person will pedal to control forward motion in a tablet-based game, such as when pedaling along a virtual path and steering to different assigned errand locations."
15731893|NCT05009524|Device|PACE (Physical and Cognitive Exercise)|"PACE involves a pedal-while-play experience in which physical and mental exercise are combined in a simultaneous, but not fully interactive way. In this condition a person will pedal while also separately steering in a tablet-based game, such as when pedaling while automatically progressing along a virtual path to different assigned errand locations."
15731894|NCT05009511|Behavioral|Learning through feedback|The goal of this investigation is to examine the influence of feedback timing on learning and brain function.
15731895|NCT05009498|Dietary Supplement|Vitamin D3 supplementation|Vitamin D3 in 50,000 IU capsules Loading dose of 150,000 IUs (3 capsules) Interval dosing of 50,000 IUs (1 capsule) every 2 weeks for 1 year
15731914|NCT05009381|Device|Stylage XXL at enrollment|Injection in the chin at enrollment
15731897|NCT05009485|Device|Current Health platform|A remote patient monitoring system which includes a small footprint device and tablet, combined with an AI-powered, cloud-based system driving advanced real-time and predictive analytics related to a patient's clinical condition. The wearable records heart rate, respiratory rate, oxygen saturation, skin temperature and step count.
15731898|NCT05009472|Device|expander with deferential opening and petit face mask|bonded expander with two screws and vertical hooks for attachment face mask. adjustment face mask with forehead and chin anchorage
15731900|NCT05009446|Procedure|endoscopic surgery|endoscopic surgery or endoscope-assisted surgery open surgery
15731901|NCT05009446|Radiation|intensity-modulated radiation therapy or volume of rotating intensity-modulated radiotherapy or Proton or heavy ion radiation therapy|radiotherapy was administrated before surgery
15731902|NCT05009446|Drug|Chemotherapy drug|Chemotherapy was administrated before surgery. Chemotherapy may also be administrated after surgery in selected cases.
15731903|NCT05009433|Behavioral|High intensity interval training program for pregnant women|"Pregnant women will participate in 8-week HIIT cycles until the day of delivery, 3 times a week, in a volume of each session of 60 minutes. The main part (15-20 min) will be conducted in a form of high intensity intervals, approx. 85-90% of maximum exercise capacity. The intervals will consist of performing exercises for 30-60 seconds, alternating with a 30-60 second rest break, in the ratio of exercise time to rest 1:2, 1:1 or 2:1, according to the individual possibilities of the participant and taking into account the training progression and stage of pregnancy. The exercise intensity will be monitored with the use of heart rate monitors, the Borg Rating of Perceived Exertion (RPE) and the Talk Test.
~After birth, women will participate in 3-month HIIT cycles from the moment of achieving postpartum readiness to training until one year postpartum. Classes will be carried out stationary or online, depending on the pandemic situation and the availability of the woman."
15731904|NCT05009433|Behavioral|Moderate intensity continuous training program for pregnant women|"Pregnant women will participate in 8-week MICT cycles until the day of delivery, 3 times a week, in a volume of each session of 60 minutes. The main part (20-25 min) will be conducted in a form of moderate intensity continuous exercise, of 70-80% of the maximum exercise capacity, e.g. in the form of high- and low-impact aerobics choreography with music. The sessions will also include resistance, neuromotor, body posture and flexibility exercises (25 min), breathing exercises, relaxation and visualization of pregnancy or childbirth (10 min). The exercise intensity will be monitored with the use of heart rate monitors, the Borg Rating of Perceived Exertion (RPE) and the Talk Test.
~After birth, women will participate in 3-month MICT cycles from the moment of achieving postpartum readiness to training until one year postpartum. Classes will be carried out stationary or online, depending on the pandemic situation and the availability of the woman."
15731905|NCT05009433|Behavioral|Standard obstetric care with extended education on healthy lifestyle|Pregnant women will get standard obstetric care according to the national law. They will attend educational sessions on a healthy lifestyle, physical activity in the perinatal period and selected aspects of pregnancy and motherhood. Educational classes will be conducted online in real time, at least once every two weeks, until one year postpartum.
15731906|NCT05009433|Behavioral|High intensity interval training program for nonpregnant women|"Nonpregnant women will participate in 8-week HIIT cycles for a period of 8 months, 3 times a week, in a volume of each session of 60 minutes. The main part (15-20 min) will be conducted in a form of high intensity intervals, approx. 85-90% of maximum exercise capacity. The intervals will consist of performing exercises for 30-60 seconds, alternating with a 30-60 second rest break, in the ratio of exercise time to rest 1:2, 1:1 or 2:1, according to the individual possibilities of the participant and taking into account the training progression. The exercise intensity will be monitored with the use of heart rate monitors, the Borg Rating of Perceived Exertion (RPE) and the Talk Test.
~For the next 12 months of the project, women will participate in 3-month HIIT cycles. Classes will be carried out stationary or online, depending on the pandemic situation and the availability of the woman."
15731907|NCT05009433|Behavioral|Moderate intensity continuous training program for nonpregnant women|"Nonpregnant women will participate in 8-week MICT cycles for a period of 8 months, 3 times a week, in a volume of each session of 60 minutes. The main part (20-25 min) will be conducted in a form of moderate continuous intensity exercise, of 70-80% of the maximum exercise capacity, e.g. in the form of high- and low-impact aerobics choreography with music. The sessions will also include resistance, neuromotor, body posture and flexibility exercises (25 min), breathing exercises and relaxation (10 min). The exercise intensity will be monitored with the use of heart rate monitors, the Borg Rating of Perceived Exertion (RPE) and the Talk Test.
~For the next 12 months of the project, women will participate in 3-month MICT cycles. Classes will be carried out stationary or online, depending on the pandemic situation and the availability of the woman."
15731908|NCT05009433|Behavioral|Standard health care with extended education on healthy lifestyle|Nonpregnant women will get standard health care according to the national law. They will attend educational sessions on a healthy lifestyle, physical activity and selected aspects of preparation to pregnancy and motherhood. Classes will be conducted online in real time, at least once every two weeks, for a period of 20 months.
15731909|NCT05009420|Other|Avocado|avocado served with crackers as breakfast
15731910|NCT05009407|Biological|Immunohistochemistry and clinical analyses on patients and corneas|Immunohistochemistry and clinical analyses on patients and corneas
15731911|NCT05009394|Procedure|Targeted Muscle Reinnervation (TMR)|Surgical procedure used to rewire injured proximal nerves to motor nerves directly innervating an otherwise redundant target muscle.
15731912|NCT05009394|Procedure|Regenerative Peripheral Nerve Interface (RPNI)|Surgical procedure where the injured nerve is split into fascicles and wrapped in free muscle grafts.
15731917|NCT05009368|Drug|Drug: Treatment B|CTL0902, single dose, daily, repeated oral administration for 7 days
15731918|NCT05009368|Drug|Drug: Treatment C|CTL0901 and CTL0902, single dose, daily, repeated oral administration for 7 days
15731919|NCT05009355|Drug|Vitamin C|antioxidant
15731920|NCT05009342|Device|below-knee soft resin cast|Patients have soft resin boot between day 0 (inclusion visit) and day 21 (follow-up visit n°1)
15731921|NCT05009342|Device|Below-knee rigid resin cast|Patients have rigid resin boot between day 0 (inclusion visit) and day 21 (follow-up visit n°1)
15731922|NCT05009329|Drug|JAB-21822|JAB-21822 will be administered orally
15731923|NCT05009329|Drug|JAB-21822|JAB-21822 will be administered orally
15731924|NCT05009316|Other|Questionnaires|Online-based questionnaires
15731925|NCT05009303|Device|OneStep Smartphone App and C-Mill Treadmill|OneStep technology is a smartphone application that utilizes smartphone sensors to provide ongoing gait diagnostics. Each participant will have two sessions, during which, they will walk on a C-Mill smart treadmill for up to 15 minutes (with a minimum of 2 minutes), while carrying 2 smartphones and being recorded via two video cameras. The second walking session, conducted under similar conditions, will be used for test-retest reliability.
15731926|NCT05009290|Drug|SHR3680|"Treatment group: SHR3680 240 mg orally once daily before or after breakfast, 28 days per cycle for a total of 12 treatment cycles (6 cycles before and 6 cycles following radical prostatectomy).
~Goserelin acetate sustained-release depot: 10.8 mg administered subcutaneously into the anterior abdominal wall once every 3 cycles (12 weeks) for a total of 12 cycles."
15731927|NCT05009290|Drug|Placebo|"Treatment group ：Placebo 240 mg orally once daily before or after breakfast, 28 days per cycle for a total of 12 treatment cycles (6 cycles before and 6 cycles following radical prostatectomy).
~Goserelin acetate sustained-release depot: 10.8 mg administered subcutaneously into the anterior abdominal wall once every 3 cycles (12 weeks) for a total of 12 cycles."
15731928|NCT05009277|Device|Device|LINDA thermal device
15731929|NCT05009264|Procedure|OMT|OMT will be performed on identified areas of trapezius trigger points
15731930|NCT05009251|Behavioral|Reminder|Mailed letter, short message service (SMS) text, and/or patient portal message
15731931|NCT05009251|Behavioral|Risk reduction|Mailed letter, SMS, and/or patient portal message
15731932|NCT05009251|Behavioral|Medical records-based recommendation|Mailed letter, SMS, and/or patient portal message
15731933|NCT05009251|Behavioral|Algorithm-based recommendation|Mailed letter, SMS, and/or patient portal message
15731934|NCT05009238|Other|lumbar stabilization exercises|selected exercises will taught to participant and practiced 3 times per week for 6 weeks
15731936|NCT05009212|Procedure|Endoscopic stricturotomy|Endoscopic stricturotomy for bowel stricture (<5 cm)
15731937|NCT05009212|Procedure|Endoscopic balloon dilatation|Endoscopic balloon dilatation for bowel stricture (<5 cm)
15731938|NCT05009199|Drug|[18F]MNI-444|Subjects will undergo PET imaging using [18F]MNI-444.
15731939|NCT05009186|Other|PSA value|We measure PSA value during and after covid-19 infection
15731940|NCT05009173|Procedure|Lumbar puncture using the stylet-in technique|This method consists of inserting the needle with the stylet-in, then only remove the stylet once the desired depth is achieved and CSF flow is expected. If no CSF comes back, the stylet is replaced before continuing to advance the needle until the subarachnoid space is entered. This is the technique generally used in our emergency department and will serve as the control treatment group.
15731941|NCT05009173|Procedure|Lumbar puncture using the stylet-out technique|This method consists of inserting the needle through the epidermis and the dermis, which is estimated as a 0.5 to 1 cm length in children, then remove the stylet before progressing through the other structures until the subarachnoid space is entered. This approach will be used in the experimental technique group.
15731942|NCT05009160|Device|dreaMS App R2.1|dreaMS App will be downloaded by all participants and all participants (PwMS and HC) will follow the same schedule
15731943|NCT05009147|Other|Home-based massage by caregivers for dementia|A total of 40 patients with dementia and their family caregivers will be included and randomly allocated to experiment (n=20) or control group (n=20). The experiment and control group will receive whole body manual massage and placebo intervention (30 minutes once per week for 8 continuous weeks), respectively.
15731944|NCT05009134|Biological|There is no intervention in this study.|There is no intervention in this study.
15731945|NCT05009121|Diagnostic Test|Box and Block Test|"At first, each person will be asked basic questions about present feelings according to their condition using a questionnaire. Than he/she will be tested by the Box and Block Test according to the Czech version of extended manual for this test in only one session. Audio recording of verbal instructions will be used.
~The results will be used only for establishing of the variability and inter-rater reliability of the Box and Block Test, not for patients' other interventions."
15731946|NCT05009108|Diagnostic Test|Purdue Pegboard Test|"At first, each person will be asked to fill in the informed agreement and answer short questionnaire. Than he/she will be tested by the Purdue Pegboard Test according to the Czech version of extended manuals for those tests in only one session. Audio recording of verbal instructions will be used and whole testing process will be video recorded which is necessary for establishing the internal variability and variability of results of the Purdue Pegboard Test.
~The results will be used only for establishing of the variability and inter-rater reliability of the Purdue Pegboard Test, not for patients' other interventions."
15731947|NCT05009095|Device|The Listening Program® with bone conduction headphones|The Listening Program method of Music-Based Auditory Stimulation is enhanced with the addition of bone conduction technology with the ABT Bone Conduction System. Bone Conduction combines the experience of listening to music through modified headphones adding subtle, synchronized acoustic vibration of the skin and skeletal system, engaging the whole body and brain in the listening process. This multi-sensory approach accelerates and expands the benefits of The Listening Program.
15731948|NCT05009082|Drug|Carboplatin|Area under curve (AUC) 5, intravenous, on day 1 every 3 weeks for 6 cycles
15731950|NCT05009082|Drug|Bevacizumab|7.5 mg/kg or 15 mg/kg (according to local standard), intravenous, on day 1 every 3 weeks starting from cycle 2 in combination with chemotherapy and thereafter for up to 1 year
15731951|NCT05009082|Drug|Niraparib|200 or 300 mg capsules once daily for up to a total of 3 years
15731957|NCT05009056|Device|Postsurgical computer guided functional appliance|After achieving ideal condylar poison by computer guided surgery. The distal extension of the final occlusal wafer will be cut and the appliance will be fitted to be utilized as a postsurgical functional appliance for condylar adaptation. Patients will be instructed to wear the splints continuously for 3 months, only being allowed to remove them when eating and brushing their teeth.
15731958|NCT05009030|Drug|COVID-19 vaccine|Lung cancer patients will receive an anti-COVID19 vaccine approved by the European Medicines Agency according to the guidelines approved by the regulatory authorities
15731959|NCT05009017|Drug|Bevacizumab|Patients with colorectal cancer or lung cancer who use originator or biosimilar of bevacizumab
15731960|NCT05009004|Behavioral|text messages to support medication adherence|text messages to support medication adherence
15731961|NCT05008991|Device|Spirometry|Spirometry assesses the integrated mechanical function of the lung, chest wall, respiratory muscles, and airways by measuring the total volume of air exhaled from a full lung (total lung capacity [TLC]) to maximal expiration (residual volume [RV]). This volume, the forced vital capacity (FVC) and the forced expiratory volume in the first second of the forceful exhalation (FEV1), should be repeatable to within 0.15 L upon repeat efforts in the same measurement unless the largest value for either parameter is less than 1 L. In this case, the expected repeatability is to within 0.1 L of the largest value.
15731962|NCT05008978|Other|Test 1|25g of available carbohydrates from White bread with 25g of available carbohydrates from Banana consumed simultaneously at time 0 min
15731963|NCT05008978|Other|Test 2|25g of available carbohydrates from Banana consumed at time -15 min and 25g of available carbohydrates from white bread consumed at time 0 min
15731964|NCT05008978|Other|Test 3|25g of available carbohydrates from White bread consumed at time 0 min and 25g of available carbohydrates from Banana consumed at time 15 min
15731965|NCT05008978|Other|Test 4|25g of available carbohydrates from White bread with 25g of available carbohydrates from Papaya consumed simultaneously at time 0 min
15731966|NCT05008978|Other|Test 5|25g of available carbohydrates from White bread with 25g of available carbohydrates from Apple consumed simultaneously at time 0 min
15731967|NCT05008965|Biological|FB825|A humanized monoclonal immunoglobulin G1 (IgG1) targeting the CεmX domain on human B lymphocytic cells expressing membrane-bound IgE (mIgE).
15731968|NCT05008965|Other|Placebo|Formulation buffer
15731969|NCT05008952|Other|High-fat shake|All participants will be given a high-fat test meal to examine their postprandial triglyceride response.
15731970|NCT05008939|Drug|Sevoflurane|Patients receive 1% sevoflurane and 30% oxygen for 1 hour.
15731971|NCT05008939|Drug|Placebo|Patients received 30% oxygen for 1 hour.
15731972|NCT05008926|Drug|Naloxegol|Administration of Naloxegol 25 mg per day by nasogastric tube (SNG) or orogastric tube (SOG). The administration should be started within the first 24 hours after the patient is admitted to intensive care and continued for the duration of the administration of the morphine derivative and until 48 hours after its discontinuation.
15731973|NCT05008926|Drug|Placebo|Administration of the placebo according to the same procedures as the experimental arm.
15731975|NCT05008900|Radiation|Salvage radiotherapy|Standard of care salvage radiotherapy to the prostate bed which may include the lymph nodes.
15731976|NCT05008887|Drug|Methotrexate|Fractional CO2 laser-assisted cutaneous delivery of methotrexate solution in stable, non-segmental vitiligo
15731977|NCT05008887|Drug|5-fluorouracil|Fractional CO2 laser-assisted cutaneous delivery of 5-fluorouracil solution in stable, non-segmental vitiligo
15731978|NCT05008887|Device|Fractional CO2 laser|Fractional CO2 laser-assisted cutaneous delivery of methotrexate and 5-fluorouracil solution in stable, non-segmental vitiligo
15731979|NCT05008874|Other|Natural History Observation|Data collection on progression of disease
15731980|NCT05008861|Procedure|Capsulized Fecal Microbiota Transplant|Capsules contained washed fecal microbiota.
15731981|NCT05008861|Drug|Anti-programmed cell death protein 1/programmed death-ligand 1 monoclonal antibody|Standard dose of one of anti-PD-1/PD-L1 mAbs administered as a 1 hour infusion every 3 weeks.
15731982|NCT05008861|Drug|Platinum based chemotherapy|Standard dose of Platinum based Chemotherapy every 3 weeks.
15731983|NCT05008848|Behavioral|Smoking Cessation Intervention|Participate in schedule gradual reduction program
15731984|NCT05008848|Other|Health Promotion and Education|Receive cessation support messages
15731985|NCT05008848|Other|Informational Intervention|Receive NCI's Clearing the Air booklet
15731986|NCT05008848|Other|Questionnaire Administration|Ancillary studies
15731987|NCT05008835|Drug|ACP-044 Dose A|Oral dose of ACP-044 Dose A
15731988|NCT05008835|Drug|ACP-044 Dose B|Oral dose of ACP-044 Dose B
15731989|NCT05008835|Drug|Placebo|Placebo
15731990|NCT05008822|Other|Motor Imaginary Training Group|After the baseline assessment, the participant will receive Motor Imaginary Program
15731991|NCT05008822|Other|Task oriented Training Group|After the baseline assessment, the participant will receive MRP and CIMT training
15731994|NCT05008783|Drug|AK104|AK104 (administered on Day 1 of each cycle, Q3W)+Oxaliplatin (130 mg/m2 intravenous infusion for 2-6 hours on Day 1, Q3W,up to 6 cycles)+ Capecitabine(1000 mg/m2, p.o., Bid, Q3W,up to 6 cycles) . Afterward, AK104 will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W)
15731995|NCT05008783|Drug|Placebo|Placebo (administered on Day 1 of each cycle, Q3W)+Oxaliplatin (130 mg/m2 intravenous infusion for 2-6 hours on Day 1, Q3W,up to 6 cycles)+ Capecitabine(1000 mg/m2, p.o., Bid, Q3W,up to 6 cycles) . Afterward,Placebo will be used for maintenance treatment (administered on Day 1 of each cycle, Q3W)
15731996|NCT05008770|Other|No intervention|No intervention
15731997|NCT05008757|Other|no drug|no intervention
15731998|NCT05008744|Procedure|Fetoscopic laser ablation|"Under ultrasound guidance, a 2 mm skin incision will be made and a 10Fr Cook Check Flow valve cannula and trocar will be introduced into the amniotic cavity.
~The communicating vessels will be located endoscopically using a Storz straight or curved semirigid fetoscopes in a fetoscopic sheath, a Humanitarian Use Device, used with permission of the Federal Drug Administration under a Humanitarian Device Exemption agreement with Karl Storz, Inc, and will be ablated with a diode laser fiber that is passed through the operating channel of the endoscope."
15731999|NCT05008731|Drug|Botulinum toxin|100 units (0.5ml) in 1 injection
15732000|NCT05008731|Other|Placebo|Placebo 0.5 ml in 1 injection
15732001|NCT05008718|Other|38% SDF group|Participants will be randomized and will receive either 38% SDF treatment or 5% NaF treatment
15732002|NCT05008718|Other|5% NaF group|Participants will be randomized and will receive either 38% SDF treatment or 5% NaF treatment
15732003|NCT05008705|Dietary Supplement|Protein supplementation|Patients will receive diary 2 doses of the protein supplement
15732004|NCT05008705|Device|Neuromuscular electrostimulation.|Patients will receive diary sessions of neuromuscular electrostimulation.
15732005|NCT05008705|Dietary Supplement|Placebo (isocaloric supplement)|Patients will receive diary 2 doses of the isocaloric supplement
15732006|NCT05008705|Device|Sham for neuromuscular electrostimulation.|Patients will not receive neuromuscular electrostimulation.
15732007|NCT05008679|Drug|Oseltamivir|at a dose of 75 mg twice daily
15732008|NCT05008666|Drug|Sintilimab|"To evaluate the short-term objective efficacy of sintilimab Sequential combined with chidamide and azacitidine in the treatment of ENKTL-HLH patients.
~To evaluate the long-term efficacy and safety of sintilimab Sequential combined with chidamide and azacitidine in the treatment of ENKTL-HLH patients.
~Exploring biomarkers that may have predictive effects."
15732009|NCT05008666|Drug|Chidamide|"To evaluate the short-term objective efficacy of sintilimab Sequential combined with chidamide and azacitidine in the treatment of ENKTL-HLH patients.
~To evaluate the long-term efficacy and safety of sintilimab Sequential combined with chidamide and azacitidine in the treatment of ENKTL-HLH patients.
~Exploring biomarkers that may have predictive effects."
15732010|NCT05008666|Drug|Azacitidine|"To evaluate the short-term objective efficacy of sintilimab Sequential combined with chidamide and azacitidine in the treatment of ENKTL-HLH patients.
~To evaluate the long-term efficacy and safety of sintilimab Sequential combined with chidamide and azacitidine in the treatment of ENKTL-HLH patients.
~Exploring biomarkers that may have predictive effects."
15732011|NCT05008666|Drug|L-DEP|L-DEP
15732012|NCT05008640|Device|TrueLoo™|TrueLoo™ is an Internet-connected, smart toilet seat that uses computer vision technology to log and capture daily bowel movements and urinations. This data is then categorized by physical excreta characteristics to train and develop machine learning algorithms that are intended to eventually identify significant changes in stool and urine in real-time.
15732013|NCT05008614|Procedure|Erector spinae plane block group|"Before surgery, an anesthesiologist will perform unilateral ESP block with catheterization under ultrasound guidance in the procedure room.
~Drug: Ropivacaine 0.75% Injectable Solution 0.2% ropivacaine is continuously infused to the erector spinae plane at T5 level via 18G 85 mm perineural catheter (Silverstim, Vygon, Ecouen, France) (basal infusion: 10ml/hr, bolus 5ml, lockout time: 20min)"
15732014|NCT05008614|Procedure|Thoracic epidural analgesia group|"Before surgery, an anesthesiologist will perform unilateral ESP block with catheterization under fluoroscopy guidance in the procedure room.
~Drug: Ropivacaine 0.75% Injectable Solution 0.2% ropivacaine is continuously infused to the erector spinae plane at T5 level via 17-gauge catheter (FlexTip Plus®, Teleflex Medical, USA) (Silverstim, Vygon, Ecouen, France) (basal infusion: 3ml/hr, bolus 1ml, lockout time: 20min)"
15732015|NCT05008601|Device|Wrist-word optical heart rate and ECG measurement device|Aino ECG: wrist-word optical heart rate and ECG measurement device
15732016|NCT05008588|Biological|Conditioned Medium|Intranasal of 160 μl of conditioned medium
15732017|NCT05008588|Biological|Umbilical Cord Mesenchymal Stem Cells|Intra-parenchymal transplantation of 1-2x10^6 UC-MSCs
15732018|NCT05008588|Procedure|Neurologic and Neutrophic Drugs|Such as clopidogrel, piracetam, citicoline
15732019|NCT05008575|Biological|anti-CD33 CAR NK cells|1-3×10^6 /KG, 3-6×10^6 /KG, 0.6-1.2×10^7/KG Treatment follows a lymphodepletion
15732020|NCT05008575|Drug|Fludarabine|recommendation: 30mg/m2 (D-5~D-3),determined by tumor burden at baseline.
15732021|NCT05008575|Drug|Cytoxan|recommendation: 300-500mg/m2 (D-5~D-3),determined by tumor burden at baseline.
15732022|NCT05008562|Other|COVID-19 RELATED MUSCLE MASS CHANGE IN THE INTENSIVE CARE UNIT|there is no interventions to the patients.
15732023|NCT05008549|Dietary Supplement|Cranberry Juice Product|"The cranberry juice product contains 100 % cranberry juice (ingredients: water, cranberry juice concentrate)
~The cranberry juice + lemon balm extract product contains 100 % cranberry juice (ingredients: water, cranberry juice concentrate) + lemon balm extract (300 mg, Robertet Groupe)
~The cranberry juice + tart cherry juice product contains 100 % cranberry juice (ingredients: water, cranberry juice concentrate) + 3 g tart cherry powder (Cherry PURE)
~The cranberry juice + L-theanine product contains 100% cranberry juice (ingredients: water, cranberry juice concentrate) + 200 mg L-theanine (Suntheanine, Taiyo International)
~L-theanine + placebo product contains L-theanine (200 mg, Suntheanine, Taiyo International) + placebo (see 5.2.1)
~The placebo product contains water, dextrose, citric acid, malic acid, fumaric acid, natural flavor, Red #40, xanthan gum, Blue #1, gum Arabic, Reb M, Steviol glycosides, and ester gum."
15732024|NCT05008536|Biological|Anti-BCMA CAR-NK Cells|1-3×10^6 /KG, 3-6×10^6 /KG, 0.6-1.2×10^7/KG Treatment follows a lymphodepletion
15732025|NCT05008536|Drug|Fludarabine|recommendation: 30mg/m2 (D-5~D-3),determined by tumor burden at baseline.
15732026|NCT05008536|Drug|Cytoxan|recommendation: 300-500mg/m2 (D-5~D-3),determined by tumor burden at baseline.
15732027|NCT05008523|Behavioral|Opioids and Police Safety Occupational Risk Reduction Training (OPS)|Potential participants are provided with a flyer with directions to enroll online. Groups are randomized by zip code (all participants with the same zip code receive the same training to avoid contamination by precinct) Both the experimental and control groups first take the online GetNaloxoneNow.org First Responder training; then the experimental group takes the online OPS training and the control group takes the online COVID training. Both groups take a pre-survey prior to both trainings and a post-survey after they complete both trainings. Both groups also receive (via email) a resource list with information that was provided in their respective trainings plus additional resources re: occupational risk reduction appropriate to each training. Every quarter for one year, participants are emailed a reminder to get back online to take the survey again.
15732028|NCT05008523|Behavioral|Opioids and Police Safety Occupational Risk Reduction Training (COVID)|Potential participants are provided with a flyer with directions to enroll online. Groups are randomized by zip code (all participants with the same zip code receive the same training to avoid contamination by precinct) Both the experimental and control groups first take the online GetNaloxoneNow.org First Responder training; then the experimental group takes the online OPS training and the control group takes the online COVID training. Both groups take a pre-survey prior to both trainings and a post-survey after they complete both trainings. Both groups also receive (via email) a resource list with information that was provided in their respective trainings plus additional resources re: occupational risk reduction appropriate to each training. Every quarter for one year, participants are emailed a reminder to get back online to take the survey again.
15732032|NCT05008497|Other|Questionnaire|Questionnaire
15732033|NCT05008484|Device|NMES|Subjects will undergo 4.5 months of open kinematic chain resistance training followed by 4.5 months of closed kinematic chain using simple rowing approach
15732034|NCT05008484|Drug|Vitamin D|2000IU oral vitamin D supplementation daily for 9 months
15732035|NCT05008484|Procedure|Passive movement|Subjects will perform simple passive movement exercise for their legs while sitting in their wheelchairs at their home. The frequency of the training will be twice weekly. .
15732036|NCT05008471|Dietary Supplement|Formula nutrition|The target energy of radiotherapy patients is recommended to be 25-30kcal/(kg·d), and the target energy of the intervention group should be increased by an additional 50% daily from the beginning of radiotherapy. Specifically, under the condition of ensuring the daily target energy 14kcal/(kg·d), formula nutrition should be added daily.
15732037|NCT05008458|Diagnostic Test|von willebrand factor and copeptin|biomarkers increase in children with febrile seizures
15732038|NCT05008445|Biological|LM-102 Injection|LM-102 Injection with dose escalation stage of 3mg/kg up to 40mg/kg, as well as dose expansion stage with recommended dose level from dose escalation stage.
15732039|NCT05008445|Combination Product|LM-102 Injection combined with SOC|LM-102 Injection with appropriate dose level(s), combined with SOC.
15732040|NCT05008432|Diagnostic Test|Home sleep apnea testing|Participants will be monitored with a WatchPAT device for home based diagnosis of OSA
15732041|NCT05008419|Behavioral|Narrative discourse treatment|The protocol will incorporate elements from prior treatment studies that showed some promise: 1) hierarchical training, 2) variety of discourse stimuli, 3) development of skills and strategies for discourse processing, 4) structured training prompts, 5) meta-cognitive and meta-linguistic strategies, and 6) integration of learning principles. Novel treatment elements will include: 1) targeting both story content and story organization, 2) use of a discourse model to guide treatment, and 3) functional communication training. Treatment will be delivered twice a week over 8 weeks. There will be four treatment phases: education, story organization, story content, and integration of story organization and content.
15732042|NCT05008406|Other|Satisfaction|Students Satisfaction
15732043|NCT05008393|Drug|PJS-539 Dose 1|Patients will receive PJS-539 dose 1 daily for 10 days.
15732044|NCT05008393|Drug|PJS-539 Dose 2|Patients will receive PJS-539 Dose 2 daily for 10 days.
15732045|NCT05008393|Drug|Placebo|Patients will receive placebo daily for 10 days.
15732046|NCT05008380|Procedure|prone positioning|3-6 hours of prone-positioning twice a day
15732047|NCT05008367|Drug|Dexamethasone|24 mg intravenous Dexamethasone (6 ml)
15732048|NCT05008367|Drug|Isotonic saline|6 ml of isotonic saline
15732049|NCT05008354|Drug|Pyridoxine|Pyridoxine tablet 40mg once daily
15732050|NCT05008354|Drug|Placebo|Placebo tablet once daily
15732051|NCT05008341|Drug|Solriamfetol 150 mg Oral Tablet|Single-dose 150 mg tablet orally administered.
15732052|NCT05008328|Other|Music therapy plus standard care during an SBT|If the participant is randomly assigned to standard care plus music therapy, a music therapist will enter the room five minutes prior to the start of the breathing trial and begin to play quiet music on a guitar. The nurse will reduce medicine to bring the participant to an alert state. The music therapist will introduce themselves and the music intervention, and will continue to play quiet guitar music and sing softly while the respiratory therapist begins the breathing trial. The music therapist will continue playing and singing for 20 minutes into the breathing trial.
15732053|NCT05008328|Procedure|Standard care during an SBT|The patient's nurse will reduce sedatives so the patient is alert and awake. The respiratory therapist will introduce themselves to the patient and inform them of the SBT, stating they will turn off the ventilator machine and allow the patient to breathe independently. The respiratory therapist will switch off the ventilator and leave the room. The respiratory therapist and nurse will both be available throughout the SBT, and the ventilator will automatically turn on if the patient stops breathing. The SBT will last for 30-60 minutes.
15732054|NCT05008315|Other|Myofascial abdominal diaphragm release|Myofascial abdominal diaphragm release
15732055|NCT05008315|Other|Direct focused scar release technique|Direct focused scar release technique
15732056|NCT05008315|Other|Direct manipulations to visceral structures|Direct manipulations to visceral structures
15732057|NCT05008315|Other|pelvic anatomy education|pelvic anatomy education
15732058|NCT05008315|Other|sham|sham
15732059|NCT05008302|Procedure|hand motor coordination in a sitting positin|Before each test, the patient was instructed on how the exercise should be done. The test consisted of two motor tasks, carried out in two different starting positions: sitting and lying down (supine). During the first examination, the subject sat on the therapeutic table (without back support), feet resting on the floor. The upper limb was to be examined in adduction, with the elbow bent in the intermediate position between pronation and supination of the forearm. In the supine position, the upper limb was stabilized at the subject's body (adduction in the humeral joint, elbow flexion in the intermediate position).
15732060|NCT05008289|Device|Magnetic transcutaneous spinal cord stimulation|In the active group, non-invasive spinal cord stimulation will be applied by placing a circular magnetic coil (Magventure®️ MagPro®️ R20) on the skin, in the upper thoracic region (thoracic level T2-T3). The intensity of stimulation will represent 100% of the motor threshold, which is determined by abdominal muscle contractions, found from single pulses, gradually applied every 10 seconds until the onset of contractions. The intermittent theta burst stimulation protocol will consist of 20 stimulation trains, with an interval of 8 seconds between trains, each train will have 20 bursts, and each burst will have 3 pulses at 50 Hertz repeated at 5 Hertz. In total 1200 pulses will be applied for 3 minutes and 58 seconds.
15732061|NCT05008289|Device|Transcutaneous electrical nerve stimulation|"To create a sensation of muscle contraction and impression of active stimulation, both the placebo and active groups will be subjected to the sensory effect of transcutaneous electrical neurostimulation (TENS). The surface electrodes of TENS (model Neurodyn®️, Ibramed®️) will be placed in parallel at the height of the thoracic level T2-T3, with the following parameters: 80Hertz, 150ms, approximately at 60 miliampère.
~In the placebo group, a coil will be allocated in the thoracic region T2-T3, however this coil will not be connected to the stimulation device, and another active coil will be positioned about 15cm behind, away from its field of view, to provide the idea from the sound stimulus that it is being stimulated."
15732062|NCT05008276|Drug|Aminohippurate Sodium Inj 20%|Diagnostic aid/agent used to measure effective renal plasma flow (ERPF)
15732063|NCT05008276|Drug|Iohexol Inj 300 MG/ML|Diagnostic aid/agent used to measure glomerular filtration rate (GFR)
15732064|NCT05008276|Drug|Dextran 40|Diagnostic aid/agent used to measure glomerular size and selectivity
15732065|NCT05008263|Diagnostic Test|Liver elastography (2D-SWE)|All patients were referred for 2D-SWE liver elastography and liver liver scintigraphy with 99mTc-mebrofenin prior to liver biopsy.
15732066|NCT05008263|Diagnostic Test|Liver scintigraphy with 99mTc-mebrofenin|All patients were referred for 2D-SWE liver elastography and liver liver scintigraphy with 99mTc-mebrofenin prior to liver biopsy.
15732067|NCT05008250|Drug|Tongmai Yangxin Pill (TMYXP)|"TMYXP is a Chinese patent medicine developed by many years of clinical practice experience. The ingredients of TMYXP are Radix Rehmanniae, Caulis Spatholobi, Polygonum Multiflorum, Colla Corii Asini, Ophiopogonis, Tortoise Shell (vinegar), Radix Codonopsis, Cassia Twig, Jujube, Schisandra Fruit, and Licorice Root. It has the effect of invigorating Qi, nourishing Yin, dredging the pulse, and relieving pain. It is used in treatment of Qi and Yin deficiency syndromes caused by coronary heart disease, angina pectoris, and arrhythmia.
~Metoprolol tartrate (a heart-selective β-blocker) is a class II antiarrhythmic medication that decreases the ventricular rate of supraventricular tachyarrhythmias by inhibition of atrioventricular conduction."
15732068|NCT05008250|Drug|metoprolol tartrate|metoprolol tartrate (a heart-selective β-blocker) is a class II antiarrhythmic medication that decreases the ventricular rate of supraventricular tachyarrhythmias by inhibition of atrioventricular conduction.
15732069|NCT05008250|Drug|placebo|simulated pills
15732070|NCT05008237|Drug|docetaxel plus Cisplatin|D1, D8 Docetaxel 35 mg/m2 + D5W 100mL MIV over 1hr D1 Cisplatin 70mg/m2 + NS 150mL MIV over 1hr every 3 weeks Treatment will be continued until disease progression or unacceptable toxic effects.
15732081|NCT05008211|Other|Information-Motivation-Behavioral skills (IMB) model-based intervention|A six-week programme
15732082|NCT05008211|Other|Control - usual care|he nurse will provide an one-hour face-to-face session to introduce the choices of domiciliary NIV and teach the patient or his/her family on how to operate and maintain the ventilator, interface and accessories, and also how to handle the common problems
15741430|NCT04930653|Other|Quality-of-Life Assessment|Ancillary studies
15732083|NCT05008198|Other|Transcranial Magnetic Stimulation|Transcranial Magnetic Stimulation is delivered as part of routine care and is not managed by this observational study.
15732086|NCT05008172|Procedure|Splenic Artery Embolization|The decision for proximal or distal (selective) embolization is at the discretion of the Interventional Radiologist. For patients with angiographically evident injury, the choice of embolization site will be left to the discretion of the operator. For patients without angiographically evident injury, proximal splenic embolization will be performed with approved materials (coils or plugs for most patients) within the main splenic artery. The embolization endpoint will be hemostasis in the main splenic artery.
15732087|NCT05008159|Behavioral|3 month community-based mobility and health intervention|"12 weekly GROUP (10-15 adults per cohort) sessions + 3 INDIVIDUAL tailored system navigation sessions at beginning, midpoint, and end of program.
~The 3-month GROUP program will include the following fixed components:
~i) weekly interactive group-based health education sessions focused on:
~increasing knowledge, skills, and behaviours related to physical activity, healthy eating, and available community supports for older adults;
~socialization to foster peer and community connections, co-learning, and decrease social isolation
~skill-building to support independence and quality of life; and
~ii) INDIVIDUAL tailored system navigation support"
15732088|NCT05008146|Radiation|Baseline [C-11]NOP-1A PET Scan|Radiotracer
15732089|NCT05008146|Drug|Hydrocortisone|Intravenous, 1mg/Kg
15732090|NCT05008146|Radiation|Post-hydrocortisone [C-11]NOP-1A PET Scan|Radiotracer
15732091|NCT05008133|Behavioral|Bicycle exercise|Stepwise increased exercise for 5 minutes at 0, 50, 100 and 150 Watts. One series lying flat in prone position, after 15 minutes of rest, series repeated at 70 degrees head up tilt.
15732092|NCT05008120|Other|No intervention|No intervention
15732093|NCT05008107|Other|Virtual reality|Using VR goggles to watch peri-operative instructional video.
15732094|NCT05008094|Diagnostic Test|Whole-exome sequencing|Whole-exome sequencing with the focus on Parkinson's disease loci.
15732095|NCT05008094|Diagnostic Test|Microbiota sequencing|Next generation sequencing of microbiota from stool and saliva samples.
15732096|NCT05008094|Diagnostic Test|Magnetic resonance imaging|Magnetic resonance imaging of the brain focused on detection of free water in Substantia Nigra using a novel protocol.
15732097|NCT05008094|Diagnostic Test|Transcranial ultrasound and Electroencephalography|Transcranial ultrasound of Substantia Nigra, as well as high resolution EEG.
15732098|NCT05008094|Diagnostic Test|ELISA (Enzyme-Linked Immunosorbent Assay)|ELISA (Enzyme-Linked Immunosorbent Assay) will be used to assess the inflammatory state, glial functions, and disease progression will also be determined through specific markers in the participant's serum and plasma samples
15732099|NCT05008094|Diagnostic Test|Fluorescent correlation spectroscopy (FCS)|Fluorescent correlation spectroscopy (FCS), more specifically, ThT fluctuating intensity fluorescent analysis (FIFA) will be used to determine the existence of pathological conformation protein forms and their relation to the disease's grade and therapy.
15732100|NCT05008068|Drug|Simvastatin|Simvastatin with PRF at site of osteotome
15732101|NCT05008055|Drug|Capivasertib|Capivasertib will be given twice a day, intermittently.
15732102|NCT05008042|Drug|Mecobalamin 5 MG|The Active substance of vitamin B12 is Mecobalamin 5 mg/ml is given intramuscularly
15732103|NCT05008042|Other|Placebo Comparator : NaCl 9 mg/ml|Sodium Chloride (NaCL) 9 mg / ml 2 ml, isotonic solution for parenteral use (Baxter) is given intramuscularly.
15732104|NCT05008029|Procedure|In situ immobilization|Immobilization with an above-elbow cast. A 2, 3, or 4-year orthopedic resident or pediatric orthopedic fellow supervised by a pediatric orthopedic surgeon will perform the procedure without reduction, sedation, or anesthesia. Analgesia will be administered with paracetamol at doses of 10-15 mg/kg/dose or tramadol 0.5-1mg/kg/dose. Supposing immobilization is not satisfactory, or the patient or family member does not authorize the procedure to be carried out by staff in training. In that case, the procedure will be supported or carried out by the pediatric orthopedic surgeon.
15732105|NCT05008029|Procedure|Reduction under general anesthesia|The participants will receive paracetamol at 10-15 mg/kg/dose or tramadol 0.5-1 mg/kg/dose for pain control until the time of surgery. Under general anesthesia, radius closed reduction, and above-elbow casting will be performed. After the reduction maneuvers, the radius reduction is satisfactory if the translation in the coronal and sagittal planes of less than 50% and angulation in the same planes is less than 10 °. If the radius does not remain reduced, it is unstable. Unstable fractures require percutaneous fixation with K-wires, a sugar tong splint immobilization, and a nerve block. The procedures will be carried out by a 2, 3, or 4-year orthopedic resident or pediatric orthopedic fellow under the supervision of a child orthopedist. Suppose reduction is not satisfactory or the patient or parent doesn´t authorize the procedure performed by personnel in training. In that case, the procedure will be supported or carried out by the pediatric orthopedic surgeon.
15732106|NCT05008003|Drug|Standard of care|Standard of care treatment as per the hospital guidelines
15732107|NCT05008003|Dietary Supplement|combination of curcumin, quercetin and Vitamin D|Soft capsule of the investigational treatment that contain 42 mg curcumin, 65 mg quercetin and 90 units Vitamin D. 4 capsules per day for 14 days.
15732108|NCT05007977|Drug|ZT-01 low dose|Single subcutaneous (SC) injection of ZT-01 3 mg during hypoglycemic clamp
15732109|NCT05007977|Drug|ZT-01 high dose|Single SC injection of ZT-01 20 mg during hypoglycemic clamp
15732110|NCT05007977|Drug|Placebo|Single SC injection of placebo during hypoglycemic clamp
15732111|NCT05007964|Device|Spatz4 Adjustable Balloon System|The Spatz4 Adjustable Balloon System is designed to assist weight loss by partially filling the stomach and inducing satiety. The intragastrical balloon is implanted endoscopically for up to 12 months.
15732114|NCT05007938|Drug|Icotinib|Icotinib is a EGFR ihibitior.
15732402|NCT05005780|Device|1 Hz rTMS|MagVenture MagPro X100: Contralesional 1 Hz rTMS.
15732115|NCT05007938|Drug|Befotertinib|An orally available, irreversible, third-generation，mutant-selective epidermal growth factor receptor（EGFR）inhibitor. Befotertinib combine with icotinib means that both drugs will be given together until disease progression or meet the discontinuation criteria.
15732116|NCT05007925|Device|Intravascular Lithotripsy|Localized peripheral intravascular lithotripsy
15732117|NCT05007912|Procedure|Esophagojejunostomy type|Use of either circular or linear stapler
15732118|NCT05007899|Drug|Ferrous sulfate|Alternate day dosing of ferrous sulfate
15732119|NCT05007873|Drug|Dasatinib|Given PO
15732120|NCT05007873|Drug|Decitabine and Cedazuridine|Given PO
15732121|NCT05007860|Biological|PCV13 vaccine and any of the FDA-approved COVID-19 vaccine products (BNT162b2, mRNA-1273, or Ad26.COV2.S) based on local availability.|Vaccines administered per standard of care
15732122|NCT05007847|Device|Apple Watch-based heart rhythm monitoring|"For the duration of the study, participants in the active arm will be asked to make ECG recordings in three circumstances:
~Routinely once per day from the day of randomisation till the 12-month visit after AF Catheter Ablation (they will be encouraged to do so at the same time each day with the option to set a reminder on the watch).
~If the AW requests them to do so (the automatic AF-notification algorithm will be active throughout the study period and if AF is suspected based on the tachogram, it will trigger notification for the participant to make an ECG recording). This will be till the 12-month time point.
~If the patient has symptoms of palpitations, pre-syncope or syncope. This will be till the 12-month time point. Monitoring should continue even if AF has been diagnosed to characterise arrhythmia burden and profile. Participants will be given the contact details of a dedicated email inbox to which to send ECGs recorded through the AW."
15732123|NCT05007821|Drug|Linezolid 600 mg|One 600mg tablet taken orally once daily (QD) in the morning during weeks 1-26
15732124|NCT05007821|Drug|Linezolid 1200 mg (QD)|Two 600mg tablets taken orally once daily (QD) in the morning during weeks 1-4
15732125|NCT05007821|Drug|Linezolid 1200 mg (TIW)|Two 600mg tablets taken orally three times per week (TIW; Mon-Wed-Fri) in the morning during weeks 5-26
15732126|NCT05007821|Drug|Bedaquiline 200 mg|Two 100mg tablets taken orally once daily in the morning during weeks 1-8
15732127|NCT05007821|Drug|Bedaquiline 100 mg|One 100mg tablet taken orally once daily in the morning during weeks 9-26
15732128|NCT05007821|Drug|Delamanid 300 mg|Six 50mg tablets taken orally once daily in the morning during weeks 1-26
15732129|NCT05007821|Drug|Clofazimine 300 mg|Three 100mg capsules taken orally once daily in the morning during weeks 1-2
15732130|NCT05007821|Drug|Clofazimine 100 mg|One 100mg capsule taken orally once daily in the morning during weeks 3-26
15732131|NCT05007808|Drug|G001 Topical Gel|Non-steroidal anti-inflammatory drug for topical administration
15732132|NCT05007808|Drug|Vehicle|Vehicle Gel for topical administration
15732133|NCT05007795|Diagnostic Test|Targeted sequencing using the GenoScreen Deeplex assay|Targeted sequencing to be performed on DNA extracted directly from clinical sputum samples using an on-demand strategy to generate a drug resistant profile. Clinicians treating the patients will have access to this and prescribe 5 or more effective drugs to the patients within 14 days of diagnosis.
15732134|NCT05007782|Drug|GS-1811|Administered intravenously
15732135|NCT05007782|Drug|Pembrolizumab|Administered intravenously
15732136|NCT05007769|Drug|Ramucirumab|Will be supplied by Lilly Oncology, free of charge to the participant
15732137|NCT05007769|Drug|Atezolizumab|Atezolizumab will be commercially available.
15732138|NCT05007769|Drug|N-803|Will be supplied free of charge to the participants by ImmunityBio
15732140|NCT05007743|Device|Transcutaneous vagus nerve stimulation|"Frequency of 30 Hz, biphasic, rectangular pulses with a pulse width of 250 µs and an intensity of 20 mA.
~Device: Easy Tens+ device (body clock, London, UK)"
15732141|NCT05007730|Dietary Supplement|Transitional-state food therapeutic nutrition supplement|"Participants will consume at least one snack-sized package of the transitional-state food supplements per day across the intervention trial."
15732142|NCT05007717|Behavioral|Data-informed Stepped Care (DiSC)|"The DiSC intervention is comprised of a data-driven system to assign adolescents to care based on their health needs and the different levels of care for each assignment group.
~The trajectory of services moves from a relative position of ALHIV autonomy to more intensive service provision. Intervention steps start with 1) multi-month refills or community treatment delivery (differentiated care); 2) a standard of care level for those with medical needs such as pregnancy or opportunistic infections or patient choice; 3) patient reminders/tracking and counseling and referral services for mental health needs; 4) case management of unsuppressed individuals, including enhanced counseling and case conference problem-solving"
15732143|NCT05007704|Behavioral|Global Experts Consensus opinion using Delphi Methodology|The Investigators will conduct iterative Delphi Rounds with Global experts to achieve consensus on Competencies required for Anesthesiologists to manage critically ill medical and surgical patients in ICU
15732144|NCT05007691|Device|Occlusal splint|Occlusal splints are hard, made of polymer biocompatible material using digital additive technology.
15732145|NCT05007678|Drug|leflunomide|leflunomide administered orally; daily loading dose of 100mg for 3 days, followed by a daily maintenance dose 10-20mg daily, to a total course of 10 days
15732146|NCT05007665|Biological|SARS-COV-2 VACCINE|the antibody titer and adverse reactions were observed.
15732147|NCT05007652|Drug|KRN125(pegfilgrastim), PLR001(plerixafor)|7.2 mg of KRN125 in Day 1 Single subcutaneous administration The concomitant drug PLR001 is administered subcutaneously once daily at a dose of 0.24 mg/kg when meets the criteria. The dosing period is 12-9 hours before apheresis on the following day.
15732148|NCT05007652|Drug|KRN8601(filgrastim), PLR001(plerixafor)|400 ug/m2 of KRN8601 from Day 1 to the end date of the Apheresis Once daily subcutaneous administration The concomitant drug PLR001 is administered subcutaneously once daily at a dose of 0.24 mg/kg when meets the criteria. The dosing period is 12-9 hours before apheresis on the following day.
15732182|NCT05007405|Other|Groups/Cohortes|Retrospective study on medical file of patients with osteoarticular infections diagnose (date of the positive bacteriological sample) between January 1, 2010 and December 31, 2020
15732183|NCT05007392|Drug|Dotinurad|Dotinurad oral tablets.
15732184|NCT05007392|Drug|Febuxostat|Febuxostat oral tablets.
15732149|NCT05007639|Other|Public Health intervention programme|The public health intervention programme combined 3 actions : a simple dissemination of information via the regional Unions of private practice physicians and the local correspondents of the regional networks (action 1), an action in the form of oral communication during regional meetings of professionals (action 2) and an action focused on each surgeon for whom the pathologist has diagnosed soft tissue sarcoma (action 3).
15732150|NCT05007639|Other|No public Health intervention programme|
15732151|NCT05007626|Other|axial length and refractive error|Comparing the correlation between heterophoria and refraction, even after age adjustment.
15732152|NCT05007613|Drug|Cabozantinib 40 MG|Cabozantinib (Cabometyx) 40 MG PO QD
15732153|NCT05007613|Drug|Atezolizumab Injection|atezolizumab (Tecentriq) 1200mg IVF 30-60mins Q3W
15732154|NCT05007600|Other|Online Interactive Courses|In the experimental group, after consensus was reached in the expert meeting (consisting of a doctor specializing in occupational therapy, a doctor specializing in nursing, and a doctor specializing in public health), a 5-days-per-week (Monday to Friday) 8-week intensive online interactive course was designed. The course was made accessible to the participants through a social network app (Line) from 12:00 to 20:30.
15732155|NCT05007587|Drug|Lenvatinib|8mg lenvatinib (weight<60kg) or 12mg lenvatinib (weight>60kg) QD
15732156|NCT05007587|Drug|mFOLFOX regimen|HAIC was performed every 3 weeks. The mFOLFOX regimen was administered via hepatic artery: oxaliplatin , 85mg/m2 , from hour 0 to 2 on day1 ; leucovorin , 400mg/m2 , from hour 2 to 3 on day 1 ; fluorouracil , 400mg/m2 , bolus at hour 3 ; and 2400mg/m2 over 46 hours on days 1 and 2.3mg/m2 , from hour 4 to 5 on day 1.
15732157|NCT05007587|Drug|ROX regimen|HAIC was performed every 3 weeks. The ROX regimen was administered via hepatic artery: oxaliplatin , 100mg/m2 , from hour 0 to 4 on day1 ;raltitrexed , 3mg/m2 , from hour 4 to 5 on day 1.
15732158|NCT05007574|Device|Microphone MI-305|Remote data collection
15732159|NCT05007561|Drug|Naltrexone Hydrochloride|oral naltrexone
15732160|NCT05007561|Drug|Placebo|oral sugar pill
15732161|NCT05007548|Drug|Ga68-Dolacga Injection|Ga68-Dolacga Injection, 2.0±1.0 mCi, single dose, iv bolus
15732162|NCT05007522|Drug|Ketotifen/Indomethacin|2 mg tablet, 75 mg SR tablet
15732163|NCT05007522|Drug|Placebo|Matching placebo tablet
15732164|NCT05007509|Biological|COVID-19 vaccine HIPRA 10|One sentinel subject and 4 additional subjects will be assigned to COVID-19 vaccine HIPRA 10 µg
15732165|NCT05007509|Biological|COVID-19 vaccine HIPRA 20|One sentinel subject and 9 additional subjects will be assigned to COVID-19 vaccine HIPRA 20 µg
15732166|NCT05007509|Biological|COVID-19 vaccine HIPRA 40|One sentinel subject and 9 additional subjects will be assigned to COVID-19 vaccine HIPRA 40 µg
15732167|NCT05007509|Biological|Commercial COVID-19 vaccine|One subject in cohort 1 and 2 subjects in Cohort 2 and 3 will be assigned to Commercial COVID-19 vaccine
15732168|NCT05007496|Biological|AV-COVID-19|DCL previously loaded with varying quantity of S-protein
15732169|NCT05007483|Dietary Supplement|BodyBio Balance Oil|nutraceutical supplement
15732170|NCT05007483|Dietary Supplement|Kirunal Fish Oil|nutraceutical supplement
15732171|NCT05007483|Dietary Supplement|BodyBio PC|nutraceutical supplement
15732172|NCT05007483|Behavioral|Modified Paleolithic Elimination diet|"Complete elimination of all gluten-, dairy-, and egg-containing foods.
~Increase fruit and vegetable intake to 6-9 servings/day comprising of 2-3 servings each of the following categories: intensely colored, sulfur-rich, and leafy greens.
~Consume 6-12 ounces/day protein including organ meats and fatty fish.
~Consume fermented foods daily.
~Consume daily servings of algae, seaweed, and nutritional yeast."
15732173|NCT05007483|Behavioral|Time Restricted Olive Oil Based (TROO) Ketogenic Diet|"Restriction of dietary carbohydrates to < 50 grams/day.
~Use olive oil (cold-pressed extra virgin preferred) to increase fat intake to >160 grams/day.
~Consume <100 grams/day protein.
~Limit dairy to 2 servings/day of whole fat options (completely exclude reduced fat dairy).
~Consume at least 3 servings/day non-starchy vegetables."
15732174|NCT05007483|Behavioral|Dietary Guidelines for Americans Diet|"Limit sodium to < 2,300 mg/day.
~Limit added sugar and saturated fat intake to <10% of kcal/day, respectively.
~Consume 5 servings of fruits and vegetables per day.
~Consume 6-9 ounce equivalents/day of grains, making at least half whole grain options.
~Consume 3 servings of reduced fat dairy per day.
~Consume 6 ounces/day protein foods."
15732175|NCT05007470|Drug|VSL #3 112.5 Capsule|VSL#3 is a commercial probiotic mixture consisting of eight bacterial strains: Four strains of Lactobacillus (Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, and Lactobacillus delbrueckii subspecies bulgaricus), three strains of Bifidobacterium (Bifidobacterium breve, Bifidobacterium longum, and Bifidobacterium infantis), and one strain of Streptococcus (Streptococcus salivarius subspecies thermophilus).
15732176|NCT05007470|Other|Placebo|100 mg sugar
15732177|NCT05007457|Other|Telerehabilitation|"Patients belonging to the experimental group will receive the brochure and, weekly a telematic comparison will take place lasting about 30 minutes, with a physiotherapist to be asked questions. The physiotherapist will be able to evaluate and modify the training program based on the patient's response.
~The tele-rehabilitation sessions will take place: once / week for the first month, once every 2 weeks for the second month and from the third month from the third month the patient can contact the professionals in case of doubts or questions regarding the exercises he is taking place at home."
15732178|NCT05007444|Drug|P2Et (Caesalpinia spinosa extract)|Patients who meet inclusion criteria will begin taking 4000mg daily, distributed in 2 doses with meals of 2000mg of P2Et extract during neoadjuvant treatment. In case of presenting toxicity, it will be lowered to the next dose level, that is, 2000 mg under the same dosage schedule and 1000 mg following the same principle. The taking of the phytomedicine will only be suspended 3 days before each cycle of standard neoadjuvant therapy and will restart 3 days after having passed the cycle. That is, in the anthracyclines and cyclophosphamide (AC) phase, the patient will start taking the phytomedicine 3 days after having received their standard chemotherapy cycle and will suspend it 3 days after the next cycle begins. For the taxane phase, the patient will take the P2Et without suspension during the treatment cycles.
15732179|NCT05007444|Drug|Placebo|After determining the optimal biological dose (OBD), the patients will be divided into the placebo arm or the treatment arm. In the anthracyclines and cyclophosphamide (AC) phase, the patient will start taking according to the asignation as stated in the drug intervention.
15732180|NCT05007431|Other|Questionnaires|Data collection will be carried out by hetero-questionnaire carried out in the presence of the questioned.
15732187|NCT05007366|Behavioral|Real-time gait biofeedback|The RTGBF interventions will include eighteen step gait training sessions. The intervention will gradually increase to 3,000 steps at the 9th and 10th session with 100% feedback. During the remaining sessions, the intervention will include 3,000 steps, but the feedback will be gradually tapered off starting with the 11th session.
15732188|NCT05007366|Behavioral|Sham real-time gait biofeedback|The Sham RTGBF interventions will include eighteen step gait training sessions. The intervention will gradually increase to 3,000 steps at the 9th and 10th session with 100% feedback. During the remaining sessions, the intervention will include 3,000 steps, but the feedback will be gradually tapered off starting with the 11th session.
15732189|NCT05007353|Behavioral|Structured Lifestyle Intervention|Structured Lifestyle Intervention (SLI) involves providing participants with intensive structure and support by a team of trainers to increase physical exercise, adhere to a healthy diet, cognitive training, increase intellectual/social stimulation, and better manage vascular risk factors.
15732190|NCT05007353|Behavioral|Self-Guided Intervention|In the Self-Guided Intervention (SGI), education about the importance of a healthy lifestyle as a preventive strategy and support to encourage change will be provided.
15732191|NCT05007340|Other|Blood draws|Blood draws will be performed by personnel that are both qualified and authorized by their employer/institution to perform the procedures. The procedures will be performed with standards expected in the context of clinical care. 40 mL (2-3 tbsp) of blood will be drawn in order to collect DNA, RNA, serum and PBMCs. Blood tubes will be sent to the Bank as per the SOP for patient blood sampling and processing. The blood will be processed, centrifuged and stored by a trained laboratory technician.
15732192|NCT05007340|Other|Other biological samples to biobank (skin, lung and muscle biopsies; bronchoalveolar lavage (BAL fluid)|If the patient's medical care or their participation in a research project involves a biopsy or surgery to remove tissue, the tissue not required for diagnosis (excess tissue) or hospital archives will be included in the biobank. This may include healthy tissue as well as tissue affected by the patient's health condition. The Investigators will not conduct extra procedures in order to obtain samples for the sole purpose of this study and will only operate on what's available. These may include blood samples, skin, lung and muscle biopsies, and bronchoalveolar lavage, all of which will be obtained from the pathology department.
15732193|NCT05007340|Other|Clinical data collection|Participant's relevant medical information from medical records, general health questionnaires and clinical assessments. The data includes gender, date of birth, race/ethnicity, habits, height, weight, vital signs, medical history, family history, pregnancy history, imaging data pertinent to ILDs and SARDs, results of routine blood tests, environmental exposures, medication and treatment exposures and adherence, function and quality of life, patient's assessment of their own health, clinical symptoms.
15732194|NCT05007340|Other|Genetic data/DNA/RNA|Results of the DNA or RNA sequencing, conducted for the Biobank and will be made available to future research; possible single nucleotide polymorphism (SNP) assays (including single SNP, low-plex or microarray-based assays).
15732195|NCT05007327|Other|Exposure to pollen and air pollution|For all subjects of the cohort, we will follow exposure to pollen and air pollution.
15732196|NCT05007314|Behavioral|Biocriminological Evidence|Participants in each of the two main groups see a case with and a case without a neurobiological explanation for criminal offending.
15732197|NCT05007288|Other|Restorative Eye Treatment (RET) cream|RET cream will be applied topically to either the left of right eyelid once daily for 4 consecutive weeks.
15732198|NCT05007288|Other|INhance with Trihex Technology|INhance will be applied topically to both eyelids once daily for 10 consecutive days after the SOC blepharoplasty surgery.
15732199|NCT05007275|Biological|1x10^9 vp AZD1222|A single dose of 1x 10^9 vp AZD1222
15732200|NCT05007275|Biological|5x10^9 vp AZD1222|A single dose of 5x 10^9 vp AZD1222
15732201|NCT05007275|Biological|1x10^10 vp AZD1222|A single dose of 1x10^10 vp AZD1222
15732202|NCT05007262|Drug|Tangningtongluo tablets|Four pills each time and three times a day after meals.
15732203|NCT05007262|Drug|Calcium dobesilate capsules|1 capsule at a time, tid,po.(morning, midday, and evening), used on an empty stomach.
15732204|NCT05007249|Procedure|Use of the Chalaxie pedagogical evaluation tool|Use of the Chalaxie pedagogical evaluation tool during two visits
15732205|NCT05007236|Drug|RP7214 + Standard of care (SOC)|RP7214 tablets will be administered orally twice a day for 14 days
15732206|NCT05007236|Drug|Placebo + Standard of care (SOC)|Placebo will be administered orally twice a for 14 days
15732207|NCT05007223|Drug|Doxycycline|200mg/day for 28 days(Given doxycycline to patients with Hailey-Hailey disease)
15732208|NCT05007210|Other|Prenatal massage therapy|Pregnant women in the intervention group had a whole body prenatal massage therapy every week between 30th and 34th gestational weeks (once a week, 5-weeks in total and 60-minutes each).Session content for the prenatal massage therapy group was created by the researcher who was 640-hours trained massaging midwife.It included 12 different massage techniques (Osborne 2015, Osborne 2021).Also, the session, which included deep tissue and Sweden massage methods, had been applied.Each session began with the pregnant woman in a side-lying position with standart special pillows (30-minutes for left, 30-minutes for right).EFM, BPP, vital signs, FHR evaluation were carried out for all participants per visiting the hospital for the study.BPP before and after prenatal massage therapy was evaluated by an obstetrician.A phone number was set for the study, and this phone number was used by the massaging midwife.The service has been provided for pregnant women to reach her whenever they want.
15732209|NCT05007197|Behavioral|The Effect of Diabetes Education Based on Learning Modality|"After controlling the metabolic values of the individuals in the intervention group, the education were carried out according to the learning modality of the people; Visual learners; education booklet, brochure, slides (enriched with pictures and videos), lecture, insulin injector-pen, glucose meters, introduction and demonstration of blood glucose tracking book Auditory learners; education booklet, slides, videos, lecture, question-answer, group work, peer group discussion, experience sharing Tactile learners; education booklet, slides, demonstration, insulin injector-pen, glucose meter doing the application of tools and equipment such as on the model, on himself, on his friend, filling in the blood glucose tracking book.
~Group-specific diabetes trainings were completed in 2 training sessions. Each training session lasted an average of 1.5 hours The learning modality of the control group were determined and standard group training was provided with the education booklet."
15732401|NCT05005780|Device|Negative peak triggered 100 Hz triplet burst TMS|MagVenture MagPro X100: Ipsilesional negative peak triggered 100 Hz triplet burst TMS.
15732210|NCT05007184|Behavioral|Chilean Warning Labels|These labels were implemented in Chile in 2016. They are shown on those less-healthy food and beverage products that do not fall within thresholds that are defined for the following nutrients: sugar, sodium, calories and saturated fats. The original labels are in Spanish but the ones that we displayed were in Arabic.
15732211|NCT05007184|Behavioral|Nutri-Score Labels|These labels were implemented by the French government in 2017. They are shown on all food and beverage products and range from A to E with the corresponding colours moving from Green to Red (symbolizing best to worst). The scores and grades are calculated based on 7 different nutrients grouped into 2 categories i.e. nutrients to consume (such as fibre) and nutrients to avoid (such as sugar). We modified the labels by adding % sugar per serving on the right side of the labels.
15732212|NCT05007171|Device|Very low calorie diet|During 3 weeks in hospital patients will eat prepared very low calorie diet composed of 50-60% complex carbohydrates with low carbo-glycemic index, 20-25% proteins and 25-30% fat
15732213|NCT05007158|Other|procalcitonin blood test|blood samples of all participants were analyzed for procalitonin levels, using a commercially available procalitonin testing kit
15732214|NCT05007145|Drug|PD-1 inhibitor|PD-1 Inhibitor 200mg D1 Q3W
15732215|NCT05007145|Drug|Albumin-Bound Paclitaxel|125 mg/m^2 D1/D8 Q3W
15732216|NCT05007145|Drug|Cisplatin|75 mg/m^2 D1 Q3W
15732217|NCT05007145|Radiation|Radiation|40Gy/2.0Gy
15732218|NCT05007132|Biological|Panitumumab 20 milligram/ML|Participants receive Panitumumab at 6mg/ kg intravenously (IV) on Day 1 and 15 of each 28-day cycle. Treatment is continued until occurrence of progression according to RECIST 1.1 criteria as evaluated by the investigator or unacceptable toxicity.
15732219|NCT05007132|Biological|Bevacizumab|Participants receive bevacizumab at 5 mg/ kg intravenously (IV) on Day 1 and 15 of each 28-day cycle. Treatment is continued until occurrence of progression according to RECIST 1.1 criteria as evaluated by the investigator or unacceptable toxicity.
15732220|NCT05007132|Drug|Trifluridine/Tipiracil Hydrochloride|Participants receive Trifluridine/tipiracil at 35 mg/m² BSA, twice daily, orally on days 1-5 and 8-12
15732221|NCT05007119|Procedure|Mckenzie Extension Protocol|"Moist Heat Pack for 10 mins McKenzie Extension Protocol Sequence
~Static:
~Lying Prone
~Lying prone in extension
~Sustained extension
~Posture correction
~Dynamic:
~Extension in lying
~Extension in lying with clinician overpressure
~Extension mobilization
~Extension in standing"
15732222|NCT05007119|Procedure|Cupping|Cupping with blood letting
15732229|NCT05007093|Drug|Anlotinib hydrochloride|If intolerance occurs, the dose can be downregulated
15732230|NCT05007080|Biological|Ad26.COV2.S|Ad26.COV2.S will be administered as intramuscular (IM) injection.
15732231|NCT05007080|Other|Placebo|Placebo will be administered as IM injection.
15732232|NCT05007067|Device|DELTA Multihole TT|Advance articular destruction generated by primary degenerative or post-traumatic arthrosis or reumatoid arthritis; fracture or avascular necrosis; congenital or acquired deformity.
15732233|NCT05007054|Procedure|PCI or CABG|The PCI performed following current standard guidelines. All patients were pre-treated with aspirin and clopidogrel before catheterization. Thereafter, heparin (70-100 IU/kg) was administered before PCI, however, the use of glycoprotein IIb/IIIa inhibitors was at the physician's discretion. Dual-antiplatelet medication was administered to the patients after PCI for at least 12 months. For CABG, the left internal mammary artery was routinely used to graft to the left anterior descending artery and completed by venous grafts to other coronary branches with standard bypass techniques. The procedure was performed by surgeons experienced in on-pump or of-pump surgery at the operator's discretion.
15732234|NCT05007041|Biological|FLUAD® Quadrivalent|Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
15732235|NCT05007041|Biological|Fluzone® HD Quadrivalent|Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
15732236|NCT05007041|Biological|SHINGRIX®|Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
15732237|NCT05007028|Drug|EMONO|Exposure to 1 hour of EMONO via facial mask
15732238|NCT05007028|Drug|Medical Air|Exposure to 1 hour of Medical Air via facial mask
15732239|NCT05007015|Procedure|Transanal Irrigation|Each participant will receive a mailed package of TAI materials, given access to the eLARS app, and have two scheduled virtual visits with a trained research nurse to learn how to use TAI once assigned to the intervention arm. These sessions will include one on one session with the nurse for review of the material, discussion of the device and any questions. TAI involves introducing an applicator into the anus for irrigation. An initial volume of 1000 mL will be suggested but can be increased to 1500mL or reduced to 500 mL as per patient preference and tolerance. Applicators are single-use instruments that can be disposed of into standard waster receptacle after each treatment. The irrigation system is multiple-use and can be used for the duration recommend by the manufacturer manual. Daily irrigation can take anywhere between 20 and 90 minutes depending on individual patient experience.
15732240|NCT05007002|Device|Robot-based therapy|Active and passive therapy tasks for proprioception and sensory processing, with use of the Kinarm End-Point Lab (BKIN Technologies Ltd., Canada)
15732241|NCT05006989|Other|Blueberry Powder|Administered 10 grams/day
15732242|NCT05006989|Other|Placebo Powder|Administered 10 grams/day
15732243|NCT05006976|Other|NSAC health only|"NSAC is an outpatient service delivered under the auspices of the specialist health care sector to patients currently on sick leave or at risk for long-term sickness absence. The service is staffed by medical doctors specialising in musculoskeletal health, physiotherapists, psychologists and welfare sector counsellors, and aims to provide patients with multi-disciplinary treatment with the intent of functional recovery. In NSAC health only, clinicians are provided survey information on potential health problems only."
15732244|NCT05006976|Other|NSAC health + MBW|"NSAC is an outpatient service delivered under the auspices of the specialist health care sector to patients currently on sick leave or at risk for long-term sickness absence. The service is staffed by medical doctors specialising in musculoskeletal health, physiotherapists, psychologists and welfare sector counsellors, and aims to provide patients with multi-disciplinary treatment with the intent of functional recovery. In NSAC health + MBW clinicians are provided survey information on potential health problems as well as information on motivation for work, barriers for return to work and work environment factors."
15732245|NCT05006963|Other|manual therapy and therapy by exercise|In general, patients will receive extra-oral massage and intraoral massage, myofascial release in the cranio-cervical musculature, mobilization of the hyoid bone and may also receive unspecific joint mobilization. Will bemouth opening exercise was also performed with the tongue on the palate, proprioceptive lateralization and protrusion exercises with hyperboloid and exercises with combinations of movements of laterality and opening, or protrusion and opening.
15732246|NCT05006950|Device|Stryker1688 Fluorescence imaging system|The purpose of this study is to use SPY fluorescence imaging systems and indocyanine green (ICG) as a tool for developing intelligent peri-operative imaging by determining the percentage of successful critical anatomy recognition and to describe complications associated with intra-operative decision making in patients undergoing laparoscopic cholecystectomy.
15732247|NCT05006937|Procedure|Dusting|Dusting is when a laser is used to break a stone down into tiny fragments that are able to pass through the urine.
15732248|NCT05006937|Procedure|Basket extraction|Basket extraction is when a small wire basket is used to remove stone fragments.
15732249|NCT05006911|Drug|Pilocarpine, brimonidine, oxymetazoline, hyaluronic acid, bromfenac (PBOHB) compound|To determine the safety and efficacy of a PBOHB compound in near vision of presbyopic patients.
15732250|NCT05006898|Combination Product|PBO to control presbyopia symptoms|Low dose PBO to control presbyopia symptoms
15732251|NCT05006885|Drug|ALT-801|Injected subcutaneously (SC)
15732252|NCT05006885|Other|Placebo|Injected subcutaneously (SC)
15732253|NCT05006872|Device|DIABE-TEXT|Participants will receive 170 text messages in their mobile phones during twelve months.
15732254|NCT05006859|Other|Cohorte|Assessment of postural wheelchair disorders, as well as PW pain, and pressure ulcers associated with sitting
15732255|NCT05006846|Other|Opioid Addiction Recovery Support Software Platform|OARS (Opioid Addiction Recovery Support) is used by providers of MAT programs to improve insight into a patient's recovery progress while promoting ownership and adherence to treatment plans. OARS also provides extensive tools to support patients with recovery from Opioid Use Disorder.
15732256|NCT05006833|Behavioral|Brief Provider Training - Bundled Approach|At each clinic randomized to bundled training, providers will be invited to participate in one, in-clinic, group-based training. Each training will last one-hour and providers will receive continuing medical education (CME) credit for participating. Trainings will focus on introducing the HPV vaccine in a bundle of the other two adolescent vaccines (Tdap and MenACWY).
15732257|NCT05006833|Behavioral|Brief Provider Training - Benefits Approach|At each clinic randomized to benefits training, providers will be invited to participate in one, in-clinic, group-based training . Each training will last one-hour and providers will receive continuing medical education (CME) credit for participating. Trainings will focus on providers presenting the HPV vaccine as safe, best if received at 11- to 12-years of age, and prevents cancer.
15732258|NCT05006833|Behavioral|Parent Interactive Text Message - Bundled Approach|Text messages sent to parents will focus on receiving all three adolescent vaccines.
15732259|NCT05006833|Behavioral|Parent Interactive Text Message - Benefits Approach|Text message will state that the HPV vaccine prevents cancer, is safe and effective, and is recommended for 11- to 12-year-olds.
15732260|NCT05006807|Device|Mechanomyograph Twitch Monitor|Measurement of train-of-four count and ratio and post tetanic count
15732261|NCT05006807|Device|Stimpod Twitch Monitor|Measurement of train-of-four count and ratio and post tetanic count
15732262|NCT05006807|Device|TetraGraph Twitch Monitor|Measurement of train-of-four count and ratio and post titanic count
15732263|NCT05006807|Device|TwitchView Twitch Monitor|Measurement of train-of-four count and ratio and post tetanic count
15732264|NCT05006807|Device|Nihon Kohden Twitch Monitor|Measurement of train-of-four count and ratio and post tetanic count
15732265|NCT05006807|Other|Palpation of twitch count|The train-of-four count is determined by manual palpation of the evoked twitch response
15732266|NCT05006794|Drug|GS-9716|Tablet(s) administered orally
15732267|NCT05006794|Drug|Docetaxel|Administered intravenously
15732268|NCT05006794|Drug|Sacituzumab Govitecan-hziy|Administered intravenously
15732269|NCT05006794|Drug|Gemcitabine|Administered intravenously
15732270|NCT05006781|Drug|DAOIB|The DAOIB dose in each group will be fixed during the 24 weeks duration
15732271|NCT05006768|Drug|Barcimiant|1 tablet contains 4 mg Barcitinib
15732272|NCT05006768|Drug|Olumiant (first dose)|1 tablet contains 4 mg Barcitinib
15732273|NCT05006768|Drug|Olumiant (second dose)|1 tablet contains 4 mg Barcitinib
15732274|NCT05006755|Combination Product|Mineral Trioxide Aggregate|Mineral Trioxide Aggregate stimulates cementoblasts to produce matrix for cementum formation and is biocompatible with the periradicular tissues thus shows a superior sealing ability when used in perforation repair
15732275|NCT05006755|Combination Product|Biodentine|Biodentine has a good sealing ability, high compressive strengths, short setting time, biocompatibility, bioactivity and biomineralization properties that make it available to be used in endodontic repair procedures
15732276|NCT05006742|Procedure|CB study arm|Included patients are randomized to receive cryobiopsy
15732277|NCT05006742|Procedure|FB-CB study arm|Included patients are randomized to receive forceps biopsy and cryobiopsy within the same session
15732391|NCT05005858|Procedure|Alveolar ridge splitting|Patients with Kennedy Class I. and II. mandibles with insufficient bone width were included in this study. Ridge splitting was carried out with the use of a piezoelectric surgery device by preparing osteotomies and after mobilization of the buccal cortical by placing an autologous bone block harvested from the retromolar region as a spacer between the buccal and lingual cortical plates. Block-grafts were stabilized by osteosynthesis screws. Implant placement was carried out after a 3-month healing period.
15732279|NCT05006703|Behavioral|Breathe4T|A digital, self-management intervention for adolescents to control their asthma using breathing retraining. The mobile-friendly website provides information about asthma and how it affects the lungs, as well as how breathing patterns can be dysfunctional. Information is presented using short (30sec-2min) video clips featuring physiotherapists, researchers and adolescent role models. Users are given tips about their practice, including choosing a suitable time and place and building up gradually. Users can plan their practice, log how their practice went and record their confidence in using the breathing techniques. There are 8 sessions including peer-led videos demonstrating breathing exercises with voiceovers and step-by-step instructions. All features and sessions can be accessed via a main dashboard where users can tailor the intervention to allow parental involvement, reminders and a preferred format for notifications (email/text). Other features include FAQs and a progress chart.
15732280|NCT05006690|Other|Spinal stabilization exercise|Spinal stabilization exercises aim at controlling the position of the trunk over the pelvis to provide optimal energy production and energy transfer to distal segments and involve the cocontraction of muscles, which may restore stability to the spine.
15732281|NCT05006677|Drug|non-vitamin K antagonist oral anticoagulants (NOACs)|Collecting information of patients with VT who received NOACs
15732282|NCT05006677|Drug|vitamin K antagonists (VKAs)|Collecting information of patients with VT who received VKAs
15732283|NCT05006677|Drug|antiplatelet agents|Collecting information of patients with VT who received antiplatelet agents
15732284|NCT05006677|Other|non-antithrombotic therapy|Collecting information of patients with VT without any antithrombotic therapy
15732285|NCT05006664|Drug|Adcetris 50 MG Injection|Treatment by study drug Brentuximab Vedotin (Adcetris) in combination with CHEP.
15732286|NCT05006664|Drug|Endoxan|Treatment by study drug Cyclophosphamide (Endoxan) in combination.
15732287|NCT05006664|Drug|Doxorubicin|Treatment by study drug Doxorubicin in combination.
15732288|NCT05006664|Drug|Etoposide|Treatment by study drug Etoposide in combination.
15732289|NCT05006664|Drug|Prednisone tablet|Treatment by study drug Prednisone in combination.
15732290|NCT05006651|Device|McGrath MAC|Intubaion with McGrath MAC
15732291|NCT05006651|Device|Trachway|Intubaion with Trachway
15732292|NCT05006638|Drug|Lipid Emulsion, Intravenous|Lipid emulsion is a mixture of soybean oil, egg phospholipids, glycerine, and is available in 10%, 20%, and 30% strengths. It has been used for decades as parenteral nutrition and for caloric supplementation and essential fatty acid deficiency. It has also been used as a carrier for lipid soluble medications
15732293|NCT05006638|Drug|Atropine|a drug used as an antidote for some types of pesticides
15732294|NCT05006638|Drug|Toxogonin|a drug used as an antidote for some types of pesticides
15732295|NCT05006638|Drug|Sodium Bicarbonate Powder and ondansetron|standard of care for treatment of aluminuim phosphide is provided for patients poisoned with aluminuim phosphide
15732296|NCT05006625|Other|Collaborative Care Model|Use of the collaborative care model to screen and deliver care for depression in adolescents and young adults aged 15-24 years seeking HIV prevention and treatment services
15732297|NCT05006612|Procedure|Serratus Anterior Plane Block|"SAPB Technique; U/S probe will be placed on the patient's midaxillary line in the transverse plane, at the level of the fifth rib, Then, using U/S guidance, A 38-mm 22-gauge regional block needle is advanced in-plane at an angle of approximately 45 degrees towards the fifth rib. After aspiration to avoid IV injection 30ml of levobupivacaine 0.25% is injected anteriorly to the rib and deep to the serratus anterior muscle.
~SAPB combined with Modified Pectoral Nerve Block :
~SAPB with injection of 20 ml levobupivacaine 0.25% as discussed before. Modified Pectoral Nerve Block:After identification of the axillary vessels, the U/S probe will turned inferolaterally till the serratus anterior and the two pectoralis muscles are detected in one plane. 10 ml of levobupivacaine 0.25%was injected between the two pectoralis muscles. After that,10 mL of levobupivacaine 0.25%is injected above this muscle."
15732298|NCT05006599|Drug|Insulin (Humulin® R U-100)|Participants will administer 40 IU of Humulin® U-100 insulin four times per day with an intranasal delivery device.
15732299|NCT05006599|Drug|Placebo|Participants will administer placebo (insulin diluent) four times per day with an intranasal delivery device.
15732300|NCT05006599|Device|Aptar Pharma CPS Intranasal Delivery Device|Participants will be assigned to receive Humulin® insulin or placebo administered through the Aptar Pharma CPS intranasal delivery device.
15732303|NCT05006560|Other|Pulmonary Rehabilitation (usual care)|Participants receive the standard inpatient pulmonary rehabilitation (PR) in a specialized German Rehabilitation Clinic. PR is a comprehensive, multidisciplinary intervention implemented by an interdisciplinary rehabilitation team. PR is based on a patient assessment followed by a combination of patient-tailored therapies. PR includes the following obligatory main components: Checking and, if required, adjusting the current COPD medication according to current guidelines; physical training (endurance training, strength training, whole body vibration muscle training); structured education; respiratory physiotherapy. PR lasts on average 25 days.
15732304|NCT05006560|Other|Pulmonary Rehabilitation (usual care) + familiarization with components of the aftercare program|Participants receive the standard inpatient pulmonary rehabilitation (PR) in a specialized German Rehabilitation Clinic. PR is a comprehensive, multidisciplinary intervention implemented by an interdisciplinary rehabilitation team. PR is based on a patient assessment followed by a combination of patient-tailored therapies. PR includes the following obligatory main components: Checking and, if required, adjusting the current COPD medication according to current guidelines; physical training (endurance training, strength training, whole body vibration muscle training); structured education; respiratory physiotherapy. PR lasts on average 25 days. Additionally, participants use several functions of the aftercare program's mobile application. This includes using the application during endurance and strength training (as part of usual care) and using a consumer activity monitor to count daily steps.
15732392|NCT05005858|Device|Creating osteotomies with piezoelectric device|Osteotomies were carried out with piezoelectric surgery device (NSK Variosurg3 Ultrasonic Bone Surgery System, NSK Europe GmbH, Eschborn, Germany)
15732393|NCT05005845|Drug|NFX-179 gel|NFX-179 topical gel is the active investigational product being studied
15732305|NCT05006560|Other|After care: Exercise and physical activity promotion|"Participants will agree with their therapist on an exercise plan (endurance and resistance training) that are made available for participants through the study's mobile app. Frequency and duration of endurance and strength training are prescribed in accordance with exercise guidelines for persons with COPD. However, they can be adjusted according to participants needs.
~Next to the exercise, participants receive physical activity counseling. This consists of phone or video calls with a therapist, group video calls with a therapist, a complementary e-learning course as well as complementary functions of the study's mobile app."
15732306|NCT05006547|Other|Electromyograph Biofeedback training of the peroneal muscle|The exercise will be performed with the subject sitting in front of a computer monitor, on an elevated chair, and his feet will be in the air. The examiner will ask the subject to perform a maximum contraction of the paronal muscles, in an open kinematic chain. After reference, the subject will begin a five-minute practice. The practice will be divided into rounds of: eight seconds of muscle work and 15 seconds rest.
15732307|NCT05006521|Drug|KN-002|KN-002 dry powder inhaler
15732308|NCT05006508|Behavioral|Lifestyle tool|Regular use of the digital Lifestyle tool
15732309|NCT05006495|Procedure|C3 laminectomy|C3 laminectomy preserving semispinalis cervicis inserted into the axis.
15732310|NCT05006495|Procedure|C3 laminoplasty|Conventional C3-6 laminoplasty, resulting in injury of semispinalis cervicis.
15732311|NCT05006482|Other|Best Practice|Receive usual follow-up survivorship care
15732312|NCT05006482|Other|Comprehensive Geriatric Assessment|Complete geriatric assessment
15732313|NCT05006482|Other|Educational Intervention|Participate in survivorship health education sessions
15732314|NCT05006482|Other|Exercise Intervention|Participate in EXCAP program
15732315|NCT05006482|Other|Questionnaire Administration|Ancillary studies
15732316|NCT05006482|Procedure|Tailored Intervention|Participate in GEM consultation
15732317|NCT05006469|Drug|Bendamustine|Bendamustine 70-90mg/m2, d1, d2 Liposome Adriamycin 15-20mg/m2, d1 or Adriamycin 10mg d1-d4 Dexamethasone 40mg qw po. (20mg, >70 years old) There is a course of treatment every 28 days, and a total of 6 courses are completed.
15732318|NCT05006456|Device|Catheter ablation|Subjects will undergo catheter ablation using the new technologies, including THERMOCOOL SMARTTOUCH® SF catheter with Visitag SURPOINT, QDOT catheter and HELIOSTAR catheter when they are used in conjunction with Carto system for AF ablations.
15732319|NCT05006443|Diagnostic Test|Cardiac Magnetic Resonance|a non-invasive assessment to determine severity of tricuspid regurgitation
15732320|NCT05006430|Biological|Fecal Microbiota Transplantation|It's an intestinal microbial suspension prepared form stool obtained from carefully and thoroughly screened healthy human donors.
15732321|NCT05006430|Other|Placebo|Placebo will be identical to the investigational product but will not contain fecal material.
15732322|NCT05006417|Drug|Botox|reconstituted at 100 units/mL, dosage will be based upon the affected muscles
15732323|NCT05006404|Device|Pulmonary Valve Replacement Surgery|Pulmonary valve replacement surgery with the Autus Valve
15732324|NCT05006391|Other|Tele-Coaching (Online) Community-Based Exercise|"PHASE 1-Intervention Phase (6 months): Participants will engage in an individual tailored home-based exercise program involving aerobic, resistance, balance and flexibility training ~60min, 3 times per week for 24 weeks. Intervention will include: Component 1) biweekly 60 min personal online coaching with a certified trainer from the YMCA (13 sessions) who will monitor and progress exercise intensity; Component 2) weekly online group-based exercise classes ~60 min each led by a trainer at YMCA; Component 3) monthly online evidence-based self-management education sessions focused on topics related to self-management and health, and physical activity living with HIV; and Component 4) a wireless physical activity monitor (WPAM) to self-monitor steps, distance, calories burned, and active minutes.
~PHASE 2: Post-Intervention (6 months): Participants will be encouraged to continue with unsupervised home / outdoor-based exercise 3 times per week and to continue using their WPAM throughout."
15732325|NCT05006378|Dietary Supplement|Chamomile Tea|Chamomile tea bags consumed by subjects as described in study arms section.
15732326|NCT05006378|Dietary Supplement|Chamomile Extract Capsule|"Chamomile extract capsules consumed by subjects as described in Experimental: Chamomile Extract Capsule study arms section."
15732327|NCT05006378|Dietary Supplement|Placebo Capsule|"Placebo capsules consumed by subjects as described in Placebo Comparator study arms section."
15732328|NCT05006365|Device|Transcranial Pulse Stimulation|A total of 30 participants (both TPS group and the waitlist control group) will receive six 30 minute-TPS sessions (300 pulse in each session, total: 1800 pulse) in 2 weeks' time (i.e., 3 sessions (Monday, Wednesday, Friday) per week, total: 3 hours), on a 1: 1 allocation ratio. Participants will be followed up at 3-month period after the intervention. A 2-week TPS intervention alongside with 3-month follow-up is sufficient enough to test the effects of TPS on depressive symptoms.
15732329|NCT05006352|Drug|DNL343|Oral repeating dose
15732330|NCT05006352|Drug|Placebo|Oral repeating dose
15732331|NCT05006339|Device|Dental Monitoring|Patients in this arm are not required to attend in-office retention appointments except if they have any problems with their retainers and when data collection is necessary. Instead they are required to submit scans of their teeth through the DM mobile application at the designated intervals.
15732332|NCT05006339|Other|Clinic Review|Patients in this arm are required to attend in clinic appointments for their retention review
15732333|NCT05006326|Drug|68Ga-PSMA|Intravenous access is established in advance, intravenous bolus injection, 68Ga-PSMA dose is about 1.85-3.7 MBq/kg body weight (0.05-0.1 mCi/kg). Patients were encouraged to drink water after injection and asked to empty their bladder before PET scan.
15732334|NCT05006326|Device|PET/MR|Each subject undergoes PET/MR imaging within 40-60 minutes after injection.
15732335|NCT05006326|Device|PET/CT|Each subject undergoes PET/CT imaging within 40-60 minutes after injection.
15732336|NCT05006313|Device|Intraoperative fluorescence angiography|Intraoperative fluorescence angiography will be used to assess tissue perfusion following initial debridement of wound.
15732337|NCT05006300|Other|Topialyse Baume Barrière|Evaluation of the efficacy of the cosmetic product SVR TOPIALYSE Baume Barrière on the reduction of topical corticosteroid consumption in children from 3 months to 17 years old presenting mild to moderate atopic dermatitis after 28 and 56 days of use, at one or two apllications /day.
15732394|NCT05005845|Drug|Vehicle gel|NFX-179 vehicle gel is the placebo comparator for this study
15732338|NCT05006287|Drug|Non-vitamin K oral anticoagulants (NOACs)|"NOAC Group (Intervention):
~Patients randomized to the NOAC group will receive a NOAC dosed according to the Canadian monograph for the respective indication. Patients receiving a NOAC before cardiac surgery will resume the same NOAC as pre-operatively, whereas patients not previously receiving a NOAC will preferentially receive apixaban according to local practice. The NOAC will be started no earlier than post-operative day 5 and based on the standard protocol depending on whether the patient has a pre-existing indication for anticoagulation or new indication (e.g. post-operative atrial fibrillation).
~Patients at high risk of thrombosis and low risk of bleeding will receive a standardized bridging protocol as early as post-operative day 3 with unfractionated heparin infusion or low molecular weight heparin until the NOAC is initiated."
15732339|NCT05006287|Drug|Warfarin|"Warfarin Group (Comparator):
~Patients randomized to the warfarin group will receive warfarin titrated to achieve a target International Normalized Ratio (INR) of 2.5 (range 2.0 to 3.0). Warfarin will be started as early as post-operative day 1 and based on the standard protocol depending on whether the patient has a pre-existing indication for anticoagulation or new indication (e.g. post-operative atrial fibrillation).
~Patients at high risk of thrombosis and low risk of bleeding will receive a standardized bridging protocol as early as post-operative day 3 with unfractionated heparin infusion or low molecular weight heparin until INR is 2.0 or above."
15732340|NCT05006274|Device|Persona Trabecular Metal Tibia|Total knee arthroplasty
15732341|NCT05006274|Device|Verasense technology|Instrumented tibial trial component
15732342|NCT05006274|Device|MUVR|Knee motion and gait sensing wearable device
15732343|NCT05006261|Device|Tele-Tai Chi|12-week simplified TC program using the Tele-TC platform at home, with recommended training sessions at least three times a week, and two or more supplementary live sessions.
15732347|NCT05006235|Drug|Epinephrine Inhalation Solution|
15732348|NCT05006235|Drug|Salbutamol|
15732349|NCT05006235|Drug|Saline Inhalants|
15732350|NCT05006222|Drug|Enzyme Replacement Agent|Enzyme replacement therapy is one such treatment and used for the management of some subtypes of MPS disease. Enzyme replacement therapy (ERT) is based on the concept of replacing the missing enzyme in the circulation to prevent the build-up of glycosaminoglycan (GAG) in the tissues
15732351|NCT05006209|Other|One visit root canal treatment|
15732352|NCT05006209|Other|Two visit root canal treatment|
15732353|NCT05006196|Diagnostic Test|Outpatient MRI|"Participation in the study includes up to a maximum of 2 study visits. The visits will include clinical measurements (height, weight, blood pressure), blood tests, MRI scan and patient symptoms and experience questionnaires.
~There will be no medical interventions as part of the study. All participants will receive standard-of-care by their healthcare provider/s. With the participant's consent, the participant's primary care physician will be made aware of their participation in the study. Furthermore, participants will be informed of any structural abnormalities found in the MRI scan (e.g. abnormal vessels, haemangioma, tumour, cyst, among others) and abnormal blood test results as these may have clinical implications. These will be managed by the routine clinical care team as part of standard care."
15732354|NCT05006183|Procedure|PCI|Percutaneous coronary intervention with Drug-Eluting Stents
15732355|NCT05006170|Drug|DTG DT 20 mg|Give 2 tabs of MYLTEGA DT (10mg) PO once daily
15732356|NCT05006170|Drug|DTG DT 25 mg|Give 2.5 tabs of MYLTEGA DT (10mg) PO once daily
15732357|NCT05006157|Device|ViaOne device|ViaOne device is designed to allow percutaneous subxiphoid pericardial access utilizing a proprietary mechanism of entry into the pericardial sac.
15741431|NCT04930653|Other|Questionnaire Administration|Ancillary studies
15732361|NCT05006131|Other|Screening for pancreatic cancer|Screening for pancreatic cancer using EUS or MRI
15732362|NCT05006118|Drug|Radio-labeled rodatristat ethyl 600 mg|Single dose of rodatristat ethyl 600 mg as an oral suspension containing a mixture of [12C]-rodatristat ethyl and [14C]-rodatristat ethyl to contain approximately 600 microcuries (uCi) of radioactivity
15732363|NCT05006105|Device|seven-day ECG Holter|Participants receive a seven-day ECG Holter after hospital discharge.
15732364|NCT05006105|Device|24-hour blood pressure monitor|Participants receive a 24-hour blood pressure monitor, approximately four weeks after hospital discharge.
15732365|NCT05006105|Other|Questionnaire: vision of mHealth|Participants receive a questionnaire concerning their vision of mHealth, approximately four weeks after hospital discharge.
15732366|NCT05006105|Other|Questionnaire: user experience & feeling of safety|Participants receive a questionnaire concerning their user experience and feeling of safety of using mHealth, after using mHealth for six months.
15732367|NCT05006105|Device|Insertable loop recorder|Participants receive an insertable loop recorder, approximately six weeks after hospital discharge.
15732368|NCT05006092|Device|ENDOMIND|CADe system for Polyp detection
15732369|NCT05006079|Drug|Morphine|immediate release oral 15mg dose
15732370|NCT05006079|Drug|Alprazolam|oral 0.25mg dose
15732371|NCT05006079|Drug|Placebo|Lactose
15732372|NCT05006066|Other|Temporal Summation|4 type of stimulations applied on the right arm
15732373|NCT05006053|Other|Interviews/Focus groups|Qualitative study (no intervention delivered)
15732374|NCT05006040|Device|Hybrid Closed Loop System|Participants will utilize the Tandem Control-IQ Professional Hybrid Closed Loop artificial pancreas system [25, 26]. This device consists of the Dexcom G6 Continuous glucose monitor (or a more recent interoperable CGM), the Tandem t:slim X2 continuous subcutaneous insulin infusion pump, and the Control-IQ professional hybrid closed loop control algorithm. The CGM is generally replaced by parents or patients and then replaced after sensor expiration or if it falls off. This CGM, like all future iCGMs, is factory calibrated and approved for direct dosing of insulin. In addition, while the system is in use, patients will conduct blood glucose level checks at least four times a day with a fingerstick and calibrate the CGM if the measurements differ by more than 20 mg/dL of fingerstick blood glucose level. The t:slim X2 insulin pump delivers rapid acting insulin via a subcutaneous cannula which is placed by parents or patients and then replaced every 3 days [30].
15732375|NCT05006027|Procedure|Percutaneous coronary intervention via the snuffbox approach|Percutaneous coronary intervention using a 7-Fr thin wall sheath (Prelude IDeal, MERIT MEDICAL, South Jordan, UT, USA) via the snuffbox approach
15732376|NCT05006014|Procedure|Tooth guided immediate implant placement|The technique of implant insertion consisted of a progressive preparation of the implant site using the anatomy of the root of the single rooted teeth to be extracted as a reference and as aid for apical engagement
15732377|NCT05006001|Drug|Colchicine and NSAID|Colchicine and nonsteroidal anti-inflammatory drug combination therapy
15732378|NCT05005988|Behavioral|Actions for Empowered Maternal Neonatal Care|"The intervention includes three 30-minute face-to-face sessions:
~Session 1. Recognizing prematurity and the NICU environment: includes definitions of prematurity, characteristics of premature infants, equipment and dynamics of NICU care. Mothers are encouraged to identify their own and contextual resources that can help empower them.
~Session 2. Identifying the care of a premature baby: aspects related to the kangaroo method, feeding, thermoregulation, among others, are presented. Knowledge is presented as an empowerment resource.
~Session 3: Preparation for the return home. Aspects related to the discharge process and transition to home are described. Includes information on the transition home, warning signs, emergency situations, physical burden, and recognition of sources of personal and professional support.
~Session on admission to the out-of-hospital kangaroo program: presents the dynamics of the kangaroo program, as well as the goals in the new care setting."
15732379|NCT05005975|Drug|MT-7117|MT-7117
15732380|NCT05005962|Device|Neurothrombectomy|Neurothrombectomy device will be used to treat patients experiencing the AIS due to large intracranial vessel occlusion within 8 hours of last known well to collect real-world data and to access clinical outcomes associated with the use of these devices.
15732381|NCT05005949|Device|Arctic Front™ Cardiac Cryoablation Catheter System|Pulmonary vein isolation will be performed with the Arctic Front™ Cardiac Cryoablation Catheter System
15732382|NCT05005936|Procedure|Ultrasonography|Undergo ABUS
15732383|NCT05005936|Procedure|Ultrasonography|Undergo WBUS
15732384|NCT05005923|Procedure|Non-surgically performed scaling and root planing|Treatment of patients with periodontitis was performed using manual and ultrasonic instruments.
15732385|NCT05005910|Drug|Vonoprazan|Vonoprazan 20 mg oral every 12 hours (total 72 hours)
15732386|NCT05005910|Drug|PPIs IV infusion|Pantoprazole 80 mg IV loading then 8 mg/hr
15732387|NCT05005897|Biological|Cyanocobalamin|Intramuscular injection of 400 µg cobalamin to children with elevated thcy at enrollment
15732388|NCT05005884|Drug|Oral intake of medication|Prescription of oral phenolics 250 mg two times daily
15732389|NCT05005884|Drug|Placebo|Prescription of oral phenolics 250 mg two times daily
15732396|NCT05005819|Drug|[18F] APN-1607|Subjects will undergo PET imaging using [18F]APN-1607.
15732397|NCT05005806|Drug|Omega 3 fatty acid|omega 3 fatty acid soft gel
15732398|NCT05005806|Drug|Placebo|placebo soft gel
15732399|NCT05005793|Drug|Sodium bicarbonate|Oral sodium bicarbonate at 0.5 mEq/kg-lean body weight/day
15732400|NCT05005793|Drug|Placebo|Placebo at 0.5 mEq/kg-lean body weight/day
15732403|NCT05005767|Procedure|scaling and root planing|will receive scaling and root planing only
15732404|NCT05005767|Procedure|Frankincense extract gel natural herbal product|will receive Scaling and root planing then. Subgingival application of Frankincense extract gel
15732405|NCT05005754|Dietary Supplement|Probiotics|During the study period, subjects are instructed to take one capsule of probiotics daily for a total of 3 months. Aside from the probiotic supplement, all participants are instructed to continue their normal routine and not make any changes to their habitual diet or exercise habits.
15732406|NCT05005754|Dietary Supplement|Placebo control|During the study period, subjects are instructed to take one capsule of placebo control daily for a total of 3 months. Aside from the probiotic supplement, all participants are instructed to continue their normal routine and not make any changes to their habitual diet or exercise habits.
15732407|NCT05005741|Drug|Beinaglutide|Patients received beinaglutide subcutaneously three times a day for 16 weeks, the dose of beinaglutide escalate from 0.06mg to 0.2mg per 3-7 days according to subject's specific situation.
15732408|NCT05005741|Drug|Dulaglutide|Patients received 1.5mg Dulaglutide subcutaneously once-weekly for 16 weeks.
15732409|NCT05005728|Combination Product|XmAb20717 + carboplatin + cabazitaxel|Subjects will receive XmAb20717 10 mg/kg IV every 2 weeks plus carboplatin target AUC 4 IV every 3 weeks and cabazitaxel 20 mg/m2 IV every 3 weeks
15732410|NCT05005728|Combination Product|XmAb20717 + olaparib|Subjects will receive XmAb20717 10 mg/kg IV every 2 weeks plus olaparib 300 mg orally twice daily
15732411|NCT05005728|Biological|XmAb20717 monotherapy|Subjects will receive XmAb20717 10 mg/kg IV every 2 weeks
15732412|NCT05005715|Drug|Dexmedetomidine|Patients were randomly assigned to the dexmedetomidine or control group. Dexmedetomidine group received intravenous dexmedetomidine and control group received intravenous normal saline during surgery.
15732413|NCT05005715|Drug|normal saline|Patients were randomly assigned to the dexmedetomidine or control group. Dexmedetomidine group received intravenous dexmedetomidine and control group received intravenous normal saline during surgery.
15732414|NCT05005702|Other|Inspiratory Muscle training|"Patients received IMT for 30-minute per day, 3 days per week for 3 weeks using the Threshold Inspiratory Muscle training device (product Phillips). During training, patients were instructed to maintain diaphragmatic breathing, and try to maintain 10-15 breaths, and rested 5-10 between breaths. As soon as the patients managed; they were encouraged to maintain 25-30 breaths at each workload. All patients wore nose-clip during training.
~Inspiratory muscle training diaries were checked weekly. The inspiratory load was set at 40%of maximal inspiratory pressure."
15732415|NCT05005689|Drug|Fluoride mouthwash (0.05%; 225ppm).|Mouthwash
15732416|NCT05005689|Drug|Tooth Mousse Plus|Tooth Mousse
15732417|NCT05005676|Diagnostic Test|acceleromyography|Simultaneous measurement of the time course of a neuromuscular block with 2 acceleromyographs
15732418|NCT05005663|Other|surgical management of incisional hernia|surgical repair of the incisional hernia
15732419|NCT05005650|Procedure|debulking surgery|debulking surgery as primary debulking surgery or interval debulking surgery
15732420|NCT05005637|Drug|Anti Tuberculosis Drug|ATT will be given in the form of fixed drug combination (FDC). Each patient will get a regimen of 2RHZE (2 months of FDC intensive phase, which contains of Rifampicin, Isoniazide, Pirazinamide, Ethambutol) + 4RH (4 months of FDC continuation phase, which contains of Rifampicin and Isoniazid). The dosage will be according to body weight, 30-37 kg: 2 tablets, 38-54 kg: 3 tablets, 55-70 kg: 4 tablets, more than 70 kg: 5 tablets. FDC drugs have to be consumed daily during intensive phase and three times a week during continuation phase.
15732421|NCT05005637|Drug|Prednisone tablet|Oral prednisone will be given at the dose of 1 mg/kgBW/day (max 60 mg/day) until the uveitis is controlled or up to 4 weeks of administration, after that the dose will be tappered off gradually.
15732422|NCT05005624|Other|ADL performance|"All validation groups address the following ten ADL tasks in 9 different combinations of light temperature (in Kelvins - K) and light intensity (in foot candles - fc) in order possible differences to be revealed among the validation groups and light combinations:
~1. Phone Book Search (PBS), 2. Supermarket receipt (SupRe), 3. Book reading (BR), 4. Cellular message (CM), 5. Cellular entry search (CES), 6. Reading computer screen (RCS), 7. Drops bottle reading (DR), 8. Subtitles reading (SubRe), 9. Open door test (ODT), and, 10. Screwdriver test (ST).
~The 9 light combinations are the following:
~3000 K - 25 fc, 3000 K - 50 fc, 3000 K - 75 fc 4000 K - 25 fc, 4000 K - 50 fc, 4000 K - 75 fc 6000 K - 25 fc, 6000 K - 50 fc, 6000 K - 75 fc"
15732423|NCT05005611|Dietary Supplement|Placebo|"A pack of powder without probiotics.
~1 pack / day"
15732424|NCT05005611|Dietary Supplement|Probiotics-1|"A pack of powder with probiotics-1
~1 pack / day"
15732425|NCT05005611|Dietary Supplement|Probiotics-2|"A pack of powder with probiotics-2
~1 pack / day"
15732426|NCT05005611|Dietary Supplement|Probiotics-3|"A pack of powder with probiotics-3
~1 pack / day"
15732427|NCT05005598|Other|catheter dysfunction|prevalence of catheter dysfunction
15732428|NCT05005585|Procedure|immediate implant|immediate implant placement with VST technique versus early implant placement with contour augmentation technique
15732429|NCT05005572|Other|Payment adjustment for home dialysis and transplant|The ETC model makes two types of payment adjustments for facilities and managing clinicians, an adjustment to the reimbursement rate for home dialysis, and a performance adjustment. The first adjustment, Home Dialysis Payment Adjustment (HDPA), raises the reimbursement rate for home dialysis for the first three years of the program; the amount of increase is 3% in 2021, and reduces to 2% in 2022, and 1% in 2023. The second adjustment, Performance Payment Adjustment (PPA), is an increase or decrease in the reimbursement rate based on the home dialysis rate and the transplant rate attributable to the participating facility or clinician.
15732430|NCT05005559|Biological|SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant|SARS-CoV-2 recombinant spike protein (25 µg) with Advax-SM adjuvant (15 mg) in two doses with a 21-day interval administered with intramuscular injections in the deltoid muscle of the non-dominant arm
15732431|NCT05005559|Biological|Saline placebo|0.9% sodium chloride (1 mL) injection in two doses with a 21-day interval administered with intramuscular injections in the deltoid muscle of the non-dominant arm
15732432|NCT05005546|Behavioral|Yoga|Yoga will be applied to mothers in the yoga group
15732433|NCT05005546|Behavioral|Laughter Yoga|Laughter Yoga will be applied to mothers in the yoga group
15732604|NCT05004116|Drug|Irinotecan and temozolomide|Irinotecan and temozolomide will be given as per institutional standard.
15732434|NCT05005533|Other|Observational|Chronic Obstructive Pulmonary Disease Severity of Individuals by Chronic Obstructive Pulmonary Disease Assessment Test, shortness of breath Modified Medical Research Council scale, cough related quality of life Leicester Cough Questionnaire, respiratory muscle strength with Maximum Inspiratory and Expiratory Pressure, Posture with Spinal Mouse device, pain with Visual Analog Scale, severity of fatigue Fatigue Physical performance of the lower extremities will be evaluated with the Short Physical Performance Test, functional mobility will be evaluated with the Time Up and Go Test, and balance will be evaluated with the Biodex Balance System
15732435|NCT05005520|Drug|DTRI-031|Investigational drug
15732436|NCT05005520|Drug|Placebo|Matching placebo to DTRI-031
15732437|NCT05005507|Drug|JNJ-73763989|JNJ-73763989 will be administered subcutaneously once every 4 weeks.
15732438|NCT05005507|Drug|PegIFN-alpha-2a|PegIFN-alpha-2a will be administered subcutaneously once weekly.
15732439|NCT05005507|Drug|Tenofovir disoproxil|Tenofovir disoproxil film-coated tablet will be administered orally once daily.
15732440|NCT05005507|Drug|TAF|TAF film-coated tablet will be administered orally once daily.
15732441|NCT05005507|Drug|ETV|ETV film-coated tablet will be administered orally once daily.
15732442|NCT05005494|Drug|Magnesium sulfate IV|Infusion of magnesium sulphate 50 mg/kg (eq. 0.5ml/kg of magnesium sulphate 100mg/ml)
15732443|NCT05005494|Drug|Placebo|Infusion of NaCl (sodium chloride) 0.9% (placebo eq. 0.5ml/kg of NaCl 0.9%)
15732444|NCT05005481|Other|NIL intervention|NIL intervention will be performed on patients.
15732445|NCT05005468|Drug|Camrelizumab|Camrelizumab is given on the first day of each cycle, intravenous drip.
15732446|NCT05005468|Drug|Famitinib|Famitinib is administered orally, once a day.
15732447|NCT05005455|Drug|bevacizumab with new manufacturing process.|3mg/kg,I.V.,single dose
15732448|NCT05005455|Drug|bevacizumab with old manufacturing process.|3mg/kg,I.V.,single dose
15732450|NCT05005429|Drug|Bintrafusp alfa|"Bintrafusp alfa (M7824) is a bifunctional fusion protein composed of the extracellular domain of the transforming growth factor β (TGF-β) receptor II (a TGF-β trap) fused to a human immunoglobulin G1 antibody blocking programmed death-ligand 1 (PD-L1).
~Day 1 of week 1 of treatment will start within 1-5 days from enrollment. Cycles will be administered every 2 weeks (±3 days) until progression or other reason to discontinue. If a pseudoprogression is suspected patient is allowed to continue treatment until loss of clinical benefit as judged by principal investigator and after the permission from the trial chair is granted.
~On Day 1 of each cycle (QW2), all eligible patients will receive:
~Bintrafusp alfa (M7824): 1200mg, IV infusion over 60 minutes Current experience revealed that IRRs to bintrafusp alfa occur seldomly and are generally mild to moderate in severity. Therefore, administration of a premedication is generally not required."
15732451|NCT05005416|Behavioral|GOALS Intervention|Weekly treatment sessions are comprised of a graded activity program focused on goal setting in 4 treatment domains: therapeutic exercise, aerobic activity, functional activity, and pain coping skills. Instruction in cognitive behavioral coping skills for pain include: explaining pain (pain neuroscience education), pacing, soliciting positive social support, cognitive restructuring, present mindedness, and symptom self-management planning.
15732452|NCT05005416|Behavioral|Usual Care Physical Therapy|Usual care will be characterized by extracting the following variables from participants' electronic health record: date of physician referral to physical therapy for neck or low back pain diagnosis (index referral), attendance of at least one PT visit (adherence), dates of first and last PT visits for index referral (duration of care), number of PT visits attended across an 8-week episode of care for the index referral (number of visits), clinic where PT services were provided (service location), and CPT billing codes issued during the episode of care for the index referral (type and frequency of treatments provided).
15732453|NCT05005403|Drug|ABBV-514|Intravenous (IV) Infusion
15732454|NCT05005403|Drug|Pembrolizumab|IV Infusion
15732455|NCT05005403|Drug|Budigalimab|IV Infusion
15732456|NCT05005390|Device|TTIP ventilation then mask ventilation|In TTIP ventilation, an endotracheal tube is inserted via the nostril or oral cavity and subsequently advanced until the tip of the tube reaches approximately the level of the glottis.
15732457|NCT05005390|Device|Mask Ventilation then TTIP ventilation|In mask ventilation, a mask is placed over the nose and mouth.
15732458|NCT05005377|Procedure|Socket Preservation with Platelet-Rich Fibrin|10cc of blood was drawn from each patient and centrifuged at 2700 revolutions per minute (rpm) for 12 minutes to obtain PRF. The extraction socket was filled with PRF and covered using a membrane made of PRF.
15732459|NCT05005377|Procedure|Socket Preservation with Freeze-Dried Bone Allograft|The extraction socket was filled with FDBA (CenoBone®; Tissue Regeneration Corp., Kish Island, Iran) without flap elevation. The socket was covered using a free palatal mucosal graft obtained by the pouch technique.
15732463|NCT05005338|Drug|BIIB122 (DNL151)|Oral doses
15732464|NCT05005338|Drug|[14C] BIIB122 ([14C] DNL151)|Intravenous doses
15732465|NCT05005325|Other|Experimental group(Male)|Hurdle steps Deep squats Inline lunges Shoulder Clearing Active straight leg raise Trunk stability pushup Rotary stability Spinal extension exam Spinal flexion exam
15732466|NCT05005325|Other|Experimental group(Female)|Hurdle steps Deep squats Inline lunges Shoulder Clearing Active straight leg raise Trunk stability pushup Rotary stability Spinal extension exam Spinal flexion exam
15732469|NCT05005299|Drug|Venetoclax|Venetoclax is administered as an oral tablet once daily.
15732470|NCT05005299|Drug|Fludarabine|Fludarabine is administered as an intravenous infusion at a dose of 30mg/m2 daily, to be administered over 30 minutes.
15732471|NCT05005299|Drug|Cyclophosphamide|Cyclophosphamide is administered as an intravenous infusion at a dose of 750mg/m2 daily, to be administered over 30 minutes and to commence 1 hour after fludarabine infusion.
15732472|NCT05005286|Other|Past history of vaginal Infections|With or without vaginal infection during pregnancy
15732473|NCT05005273|Drug|Nivolumab|Specified dose on specified days
15732474|NCT05005273|Drug|Ipilimumab|Specified dose on specified days
15732475|NCT05005273|Drug|BMS-986207|Specified dose on specified days
15732476|NCT05005273|Other|Placebo|Specified dose on specified days
15732477|NCT05005260|Drug|Bupivacaine HCl|Subjects randomized to the continuous interscalene nerve block group will receive a loading dose of 15-20 mL bupivacaine HCl 0.5% followed by a continuous catheter infusion of bupivacaine 0.2% at 8 mL per hour for 72 hours.
15732478|NCT05005260|Drug|Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj|Subjects will receive a one-time interscalene nerve block injection of 5 mL of bupivacaine 0.5% (25 mg) admixed with 10 mL of liposomal bupivacaine (133 mg).
15732479|NCT05005247|Biological|GBS-NN/NN2|GBS-NN/NN2 containing 50 μg of GBS-NN and 50 μg of GBS/NN2
15732480|NCT05005234|Drug|GFH925|Administered as an oral tablet formulation
15732481|NCT05005221|Behavioral|Automated text messages|Automated text messages will be used to facilitate blood sample collection at home for therapeutic drug monitoring of tacrolimus and mycophenolate. Participants will collect dried blood samples on 4 occasions. Two days in the clinical with simultaneous venipuncture (one sample) and two days at home with 4 samples collected at specified time points over 8 hours.
15732482|NCT05005208|Other|rehabilitation program with the support of the technological platform SI-ROBOTICS|"A 16-treatment session will be conducted, divided into 2 training sessions per week, for 8 weeks. The therapy sessions last 60 minutes; each session will involve 2 patients at time. Cardiac and respiratory activity monitoring is planned during robotic treatments in order to detect the heart rate during physical activity. Individual participants must complete at least 80% of the sessions. Recovery of 2 sessions will be possible.
~Each session involves the following activities:
~Breathing, relaxation and postural harmonization exercises;
~Active mobility and stretching exercises;
~Irish dance with the SI-ROBOTICS system;
~Relaxation exercises."
15732483|NCT05005195|Radiation|Low dose abdominal computed tomography scan|A policy of invitation to a targeted community-based non-contrast CT screening of the abdomen in those at risk of kidney cancer
15732484|NCT05005182|Drug|Hydroxyurea|Given PO
15732485|NCT05005182|Biological|Luspatercept|Given SC
15732486|NCT05005169|Diagnostic Test|SGB PCR|"This is a multi-center, randomized cluster and crossover study, and is open-label. The cluster is defined by the hospital center. Each center will therefore experiment with both strategies and the hospital centers will be randomized according to two arms:
~Arm n°1 : 1st period with SGB culture strategy and 2nd period with SGB PCR strategy.
~Arm n°2 : 1st period with SGB PCR Strategy and 2nd period with SGB culture Strategy Each inclusion period will last 6 weeks, with a 1-month wash-in period before each of the two inclusion periods of the study (training of the teams in intrapartum PCR detection). A wash-out period is not necessary in this study because the PCR machine will be removed from the centers when switching to the GBS culture strategy.
~During these two periods, all patients meeting the inclusion and non-inclusion criteria will be included in the study after presentation of the study and oral consent."
15732487|NCT05005169|Diagnostic Test|SGB culture|"This is a multi-center, randomized cluster and crossover study, and is open-label. The cluster is defined by the hospital center. Each center will therefore experiment with both strategies and the hospital centers will be randomized according to two arms:
~Arm n°1 : 1st period with SGB culture strategy and 2nd period with SGB PCR strategy.
~Arm n°2 : 1st period with SGB PCR Strategy and 2nd period with SGB culture Strategy Each inclusion period will last 6 weeks, with a 1-month wash-in period before each of the two inclusion periods of the study (training of the teams in intrapartum PCR detection). A wash-out period is not necessary in this study because the PCR machine will be removed from the centers when switching to the GBS culture strategy.
~During these two periods, all patients meeting the inclusion and non-inclusion criteria will be included in the study after presentation of the study and oral consent."
15732488|NCT05005156|Biological|Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) (Ad5-nCoV)|All participants will receive two doses vaccine and will be followed to monitor vaccine candidate safety, immunogenicity, and efficacy for a duration of 52 weeks. Fifty four days after the first vaccination, all participants will receive a second injection.
15732489|NCT05005130|Other|TASKPEN|"The package of integrated HIV/NCD services:
~WHO PEN protocols, algorithm, & training materials adapted for Zambia
~Access to cardio-metabolic condition screening & laboratory monitoring
~Non communicable disease-focused electronic medical record module
~Integrated non-communicable/HIV care (one stop shop for services)
~Trained non-physician providers able to provide integrated care"
15732490|NCT05005117|Procedure|Laparoscopic operation|Operation
15732491|NCT05005117|Procedure|Open operation|Operation
15732492|NCT05005091|Dietary Supplement|Oral carbohydrate|100 ml oral carbohydrate two hours ago preoperatively
15732493|NCT05005078|Drug|WST-057|WST-057 topical solution
15732494|NCT05005065|Drug|IN-C005 X mg|Oral capsule
15732495|NCT05005065|Drug|IN-A001 Y mg|Oral tablet
15732496|NCT05005065|Drug|IN-C005 Y mg|Oral capsule
15732497|NCT05005065|Drug|IN-C005 Z mg|Oral capsule
15732498|NCT05005052|Drug|Vessel|Sulodexide has protective effect on the endothelium, antithrombotic, fibrinolytic and anti-inflammatory effects. In the last 20 years, it has been well established in the common practice and its efficacy and safety have been demonstrated notably in the treatment of venous diseases such as post-thrombotic syndrome of the lower extremities, secondary prevention of deep and superficial venous thrombosis, supportive treatment of leg venous ulceration, ischemic disease of the lower limbs; symptomatic therapy of intermittent claudication, treatment of diabetic ulcers and microcirculation disorders of various aetiology. Patients with CVD were shown to respond quickly to sulodexide therapy in single arm observational studies. Sulodexide seems to provide both symptomatic and causal therapy.
15732499|NCT05005052|Drug|Placebo|Placebo and no compression or venopharmaceutical regimen
15732562|NCT05004506|Drug|Adductor Canal Block|The anesthesia provider will identify the adductor canal using ultrasound guidance and inject 15ccs of 0.5% marcaine with epinephrine around the saphenous nerve.
15732563|NCT05004506|Drug|Intra-articular Injection|receive 20ccs of 2% lidocaine with epinephrine as an intra-articular injection
15732502|NCT05005013|Other|Transcranial Direct Current Stimulation (tDCS)|tDCS is noninvasive brain stimulation device that modulates brain activity by delivering a low-intensity electrical current (2.0 mA) through sponge electrodes placed on the scalp.
15732503|NCT05005013|Other|Sham - Transcranial Direct Current Stimulation (tDCS)|The tDCS device is programmed to mimic active tDCS.
15732504|NCT05005013|Other|Mindfulness|Participants will follow an audio track for guided mindfulness during the stimulation.
15732505|NCT05005000|Biological|Micro-Fragmented Adipose Tissue (MFAT)|1ml of autologous micro-fragmented adipose tissue will be used.
15732506|NCT05005000|Drug|Triamcinolone Acetonide 10mg/mL|The control group will receive a 1ml intraarticular injection of triamcinolone acetonide 10mg/ml.
15732507|NCT05004987|Drug|Escitalopram Oxalate|The daily dose of ESC/PBO will be 10 mg for the first 2 weeks, then increase to 20 mg as tolerated, with an option to reduce back to 10 mg if necessary.
15732508|NCT05004987|Drug|Placebo|Daily dose of placebo will mimic that of ESC.
15732509|NCT05004974|Drug|Sintilimab|Sintilimab is administered every 3 weeks (200mg, IV).
15732510|NCT05004974|Drug|Pemigatinib|Pemigatinib 13.5 mg once daily (QD) orally, continuous administration.
15732511|NCT05004948|Other|Exercise training|The first group conducted a resistance exercise program (REP, 50-60% of 1RM, for 40-50 min) combined with metformin, the second group conducted an aerobic exercise program (AEP, 50-70% maxHR, for 40-50 min) combined with metformin, and the third group received only metformin without exercise intervention (Met group). The study program was conducted thrice weekly for consecutive twelve weeks.
15732512|NCT05004935|Dietary Supplement|beetroot juice|single intake of beetroot juice containing 800mg nitrates
15732513|NCT05004935|Other|nitrate|single intake of 800mg nitrates
15732514|NCT05004922|Other|Embryo transfer into upper cavity|Transfer of embryos in upper cavity
15732515|NCT05004922|Other|Embryo transfer into midcavity|Transfer of embryos in mid cavity
15732516|NCT05004909|Drug|0.05% Tretinoin|Topical 0.05% tretinoin cream applied daily every night by the subjects according to assigned randomization
15732519|NCT05004883|Behavioral|Regulation of Cues Enhanced|ROC is based on the Behavioral Susceptibility Theory and designed to incorporate psychoeducation, cue-exposure treatment, appetite awareness training, coping skills, and self-monitoring of satiety and cravings to treat high Food Responsiveness and low Satiety Responsiveness. BWL and ROC will be integrated for this arm, to capitalize on the strengths of both treatments. All participants will be taught to decrease caloric intake and increase physical activity, and to use all of the behavioral skills provided in BWL. However, they will also be taught models of hunger and satiety and about food cue reactivity, and will learn skills to manage these. This arm will include an experiential component, including hunger monitoring during dinner and participating in exposure exercises.
15732520|NCT05004883|Behavioral|Behavioral Weight Loss|The BWL program includes dietary, physical activity, and behavioral change recommendations. All participants will be instructed on how to consume a balanced deficit diet of conventional foods; individual goals for energy intake will be based on initial body weight. Participants will be instructed in measuring portion sizes, counting calories, and self-monitoring food intake. The physical activity program will focus on increasing both lifestyle activity and structured exercise programs. Behavior change recommendations include stimulus control, self-monitoring, goal setting, managing high-risk situations, meal planning, slowing eating, problem solving, social support, cognitive restructuring, lapse and relapse prevention skills, and maintaining weight loss.
15732521|NCT05004883|Behavioral|Nutrition Education, Stress Management and Social Support|Topics included will be stress management/relaxation, social support, and nutrition education. There will be a strong mindfulness component to this group.
15732522|NCT05004870|Device|Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine)|The ultrasound device used is cleared for HCP-supervised use in environments where healthcare is provided by trained HCPs. No changes to the design or manufacture have been made for this study.
15732564|NCT05004480|Device|Treadmill|Electronic treadmill, Hammer T-2000 Treadmill, 2,5 HP - 140 Kilograms
15732675|NCT05003544|Procedure|Group A|PENG BLOCK
15732676|NCT05003544|Procedure|Group B|Intra-articular
15732677|NCT05003544|Procedure|Group C|Quadratus lumborum block
15743470|NCT04913311|Other|Quality-of-Life Assessment|Ancillary studies
15732524|NCT05004844|Diagnostic Test|Viscoelastic assays and aggregometry tests|Viscoelastic assays and aggregometry tests performed with ROTEM will allow us to characterize the clot forming abilities and platelet functions of our patients. ROTEM is used routinely for aiding clinicians in choosing the appropriate blood products for patients ROTEM requires samples of whole blood in an amount that does not entail additional burden or risk for patients. In our study, viscoelastic assays and aggregometry will be performed upon arrival, and 24-,48-,72-hours post-admission.
15732526|NCT05004818|Procedure|GVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocol|GVS stimulation coupled with inverse phase rotatory chair stimulation at sinusoidal harmonic acceleration protocol
15732527|NCT05004818|Procedure|Sham procedure|Participants with severe motion sickness were sited in the the rotatory chair with the videonystagmography recorder masking their eyes, while two galvanic vestibular stimulation electrodes were connected to the mastoid processes. No active stimulus was given.
15732528|NCT05004805|Drug|Methylene Blue|MB administered topically as a 0.02% solution nasal spray in COVID-19 patients requiring hospitalization.
15732529|NCT05004805|Drug|Saline nasal spray|Saline administered topically as nasal spray in COVID-19 patients requiring hospitalization.
15732530|NCT05004792|Other|DermLoop Learn|DermLoop Learn is our AI augmented digital educational platform with case training on a library of 18,000+ benign and malignant skin lesion as well as written learning modules for the most common skin lesion diagnosis.
15732531|NCT05004779|Procedure|human stem cell conditioned media was applied after non-ablative laser therapy|After laser treatment on hypertrophic scars, human stem cell media was applied to one side
15732532|NCT05004779|Procedure|normal saline was applied after non ablative laser therapy|physiological saline was applied to the other side.
15732533|NCT05004766|Other|Robot assisted gait training with virtual reality|Using the VR system during robot training, the auditory stimulation of VR was applied along with the image of walking of a forest road or coastal road at the same speed as the robot walking speed. The VR programs are a composition of scenic beaty with sounds of nature. Each program is a blend of scenes such as the ocean, desert, forest, flowers, waterfalls, and wildlife.
15732534|NCT05004753|Dietary Supplement|Artemisinin|a herbal supplement
15732535|NCT05004753|Drug|Dexamethasone|corticosteroids
15732536|NCT05004740|Other|Vaccinated Pregnant or Lactating persons|vaccinated lactating persons from Sinai Health System or the general public
15732541|NCT05004675|Biological|lerodalcibep|300 mg
15732542|NCT05004675|Drug|Inclisiran|284 mg
15732547|NCT05004636|Drug|Adding Magnesium as an adjuvant to the adductor canal Block (ACB) for same-day discharge total knee arthroplasty|Post-operatively all patients will have an ultrasound-guided adductor canal block (ACB) with 30cc of 0.25% bupivacaine. Half of the patients (selected randomly using random number table) will receive 150mg of magnesium sulfate (0.3mL) in the block and the other half will receive 0.3 mL of saline in the block.
15732548|NCT05004623|Device|Sentinel Lymph Node Biopsy|Detection of sentinel lymph nodes by indocyanine green (ICG) fluorescent dye technique, using a prototype of the Easy Light device.
15732549|NCT05004610|Drug|Sodium Lactate Solution|continuous intravenous infusion of half-molar sodium lactate
15732550|NCT05004597|Other|three dimensional photography using a 3dMDHead System (3dMD, Atlanta, GA, USA)|A series of 3D craniofacial photos were captured using a 3dMDHead System (3dMD, Atlanta, GA, USA) within 7 days before or after the age of 1, 2, 4, 6, 9, and 12 months.
15732551|NCT05004584|Other|Wheat home-based appetite assessment|Home-based appetite assessment with diet based on wheat cereal products.
15732552|NCT05004584|Other|Rye home-based appetite assessment|Home-based appetite assessment with diet based on rye cereal products.
15732553|NCT05004584|Other|Wheat clinic-based appetite assessment|Clinic-based appetite assessment with diet based on wheat cereal products.
15732554|NCT05004584|Other|Rye clinic-based appetite assessment|Clinic-based appetite assessment with diet based on rye cereal products.
15732555|NCT05004584|Other|Rye/Wheat clinic-based appetite assessment with blood sampling|Clinic-based appetite assessment with diet based on rye or wheat cereal products and continuous blood sampling.
15732556|NCT05004571|Drug|EQU-001|EQU-001 in 10 and 20 mg capsules
15732557|NCT05004571|Drug|Placebo|Matched placebo
15732558|NCT05004558|Other|Remote-based Resistance Exercise Training|All participants enrolled in the trial will receive supervised remote-based resistance exercise training. The exercises will be performed with the use of Therabands and will include 8-10 exercises performed for 1 set of 15 repetitions, performed 3 days per week for 24 weeks.
15732559|NCT05004545|Drug|Propofol|Propofol infusion according to body weight will be compared with sevoflurane acording to MAC % to see the lactate level and hemodynamic parameters of CABG patients
15732560|NCT05004519|Drug|Dexmedetomidine Injection [Precedex]|dexmedetomidine or remifentanil during laparoscopic gastric bypass
15732561|NCT05004519|Drug|Remifentanil|dexmedetomidine or remifentanil during laparoscopic gastric bypass
15732565|NCT05004467|Other|Mobilization With Movement Technique|The researcher explains cervical movements to the patient to be done while the technique is performed. This movements will be the painful and limited movements detected in goniometric intervention before the treatment and movements done actively and in all range of motion.
15732566|NCT05004454|Dietary Supplement|Bacillus subtilis BS50 spore preparation|Subjects will consume 1 capsule containing 2x10⁹ CFU of a Bacillus subtilis BS50 spore preparation once daily for 42 days.
15732567|NCT05004454|Dietary Supplement|Maltodextrin|Subjects will consume 1 capsule containing maltodextrin once daily for 42 days.
15732568|NCT05004441|Drug|Fruquintinib Combined With mFOLFOX6/FOLFIRI|Fruquintinib (3mg) will be given p.o. daily
15732569|NCT05004428|Other|No intervention|Retrospective population-based study utilizing administrative data without any intervention.
15732570|NCT05004415|Drug|AT-527 (R07496998)|Study participants will receive a single radiolabeled dose of 550 mg AT-527.
15732571|NCT05004389|Diagnostic Test|MRI|white matter integrity and brain structural connectivity metrics
15732572|NCT05004389|Diagnostic Test|blood draw|post-stroke serum/plasma levels of BDNF, VEGF, IL-6, IL-10, CRP, TNFalpha, MMPs, IGF-1, cGP
15732573|NCT05004389|Other|Clinical assessments|measures of strength, balance, and mobility
15732574|NCT05004376|Behavioral|Text Messaging|Text messages based on behavioral theory to encourage scheduling colorectal cancer screening.
15732575|NCT05004363|Drug|Lokelma Oral Product|Potassium binder
15732576|NCT05004350|Drug|Encorafenib|oral capsule
15732577|NCT05004350|Drug|Cetuximab|intravenous infusion
15732578|NCT05004350|Drug|FOLFIRI|"Combination of:
~irinotecan ( also known as: Camptosar, Camptothecin-11 and CPT-11) intravenous infusion, folinic acid (also known as: 5-formyl tetrahydrofolic acid and leucovorin) intravenous infusion, and 5-FU (also known as; fluorouracil) intravenous bolus/intravenous infusion"
15732579|NCT05004324|Biological|FURESTEM-AD® inj. 5.0 X 10^7 cells/1.5 mL|the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions)
15732580|NCT05004324|Biological|Placebo|the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions)
15732581|NCT05004311|Drug|Cenerimod|A single oral dose of 0.5 mg cenerimod will be administered as a film-coated tablet in the morning of Day 1 under fasted conditions
15732582|NCT05004298|Other|Animal Assited therapy|The intervention will be structured in 10 group sessions, with a weekly frequency and one hour duration.
15732583|NCT05004285|Drug|[F-18]Florastamin|A single dose of [F-18]Florastamin at 10 ± 1 mCi is IV administered at Visit 2, and [F-18]Florastamin PET/CT images are obtained from the head to thigh after 110 ± 10 minutes.
15732584|NCT05004272|Procedure|Massage|20-minute manual full-body massage
15732585|NCT05004272|Procedure|Gymnastics|20-minute moderate body workout
15732586|NCT05004272|Other|Lecture|20-minute lecture on medicinal herbs
15732587|NCT05004259|Drug|Daratumumab / Hyaluronidase Injection|Subcutaneous injection of daratumumab and hyaluronidase
15732588|NCT05004233|Biological|Blood collection before antiplatelet treatment|Blood sample (17ml) will be collected in the neurovascular department to be processed for platelet ultrastructural analysis before the onset of an antiplatelet treatment
15732589|NCT05004233|Biological|Blood collection after antiplatelet treatment|"A follow-up will be carried out 5 to 8 days after the initiation of the treatment.
~A blood test will be taken in the NeuroVascular Unit"
15732590|NCT05004220|Procedure|Plasmapheresis|Procedure whereby plasma is separated and extracted from anticoagulated whole blood and the red cells retransfused to the donor.
15732591|NCT05004207|Diagnostic Test|99mTc Scintigraphy|"After fasting for at least 8 to 12 hours, standardized meal mixed with 99mTc-sulfur colloid radiolabeled test will be administered as quickly as possible, optimally within 10 min. Imaging will be obtained with Siemens SYMBIA E dual head (SPECT) scanner in a format of at least 128 x 128 pixels. Anterior and posterior planar images (or a single left anterior oblique image) with the distal esophagus, stomach, and proximal small bowel in the field of view will be obtained for 1 min immediately after ingestion of the test meal and repeated images will be obtained in the same projections with 2 min static images at hourly intervals up to 6 h and at 24 hours as was used for the initial images.
~Next day LHBT will be performed after at least 12 hours of fasting. Following administration of test substrate (Lactulose 10 grams) with one cup of water, breath samples will be analyzed for hydrogen every 15 minutes for 1 hour followed by every half hour for next 2 hour with LACTOFEN 2 device."
15732592|NCT05004194|Procedure|Vestibular Caloric Stimulation|Irrigation of the right external ear canal
15732593|NCT05004181|Biological|BNT162b2|Intramuscular (IM)
15732594|NCT05004181|Biological|BNT162b2 (B.1.1.7 + B.1.617.2)|Intramuscular (IM)
15732595|NCT05004181|Biological|BNT162b2 (B.1.1.7)|Intramuscular (IM)
15732596|NCT05004181|Biological|BNT162b2 (B.1.617.2)|Intramuscular (IM)
15732597|NCT05004168|Other|Day Gel-0120|Two milligrams of test article applied to the test area. The test products are Day Gel-0120C and Day Gel-0120-D. The products are applied together on the test area with
15732598|NCT05004168|Other|P5 Reference Standard (SPF 35 reference)|The reference product is P5 according to ISO 24444:2019. The application of reference product is similar with test product.
15732599|NCT05004155|Diagnostic Test|24 hour pH & impedance monitoring|24 hour pH impedance monitoring will be done on healthy subjects so that normative data specific to indian population can be generated.
15732600|NCT05004142|Drug|FCN-437c+Fulvestrant|FCN-437c 200mg, oral administration under fasting conditions, QD, for 21 days, with 7-day discontinuation, 28 days for 1 cycle; Fulvestrant, C1D1 and C1D15 and Day 1 of each cycle, 500mg/day, intramuscularly.
15732601|NCT05004142|Drug|FCN-437c+Letrozole+Goserelin|FCN-437c 200mg, oral administration under fasting conditions, QD, for 21 days, with 7-day discontinuation, 28 days for 1 cycle; Letrozole 2.5 mg, QD, for continuous dosing; Goserelin 3.6 mg, subcutaneously, once every 28 days.
15732602|NCT05004129|Drug|Tideglusib|All subjects will receive weight-adjusted 1000 mg tideglusib following a titration period of 2 weeks at a weight-adjusted dose of 400 mg and 2 weeks at a weight-adjusted dose of 600 mg tideglusib.
15732603|NCT05004116|Drug|Repotrectinib|TPX-0005 (Repotrectinib) will be taken orally twice daily in 28-day cycles without regard to food and will be administered orally before administration of irinotecan and temozolomide (exception: C1, TPX-0005 (Repotrectinib) will be administered once daily x 14 days, then twice daily D15-D28).
15732605|NCT05004103|Other|Cosmetic products application|Female healthy volunteers applied cosmetic products (cleanser and moisturizer) in the morning and afternoon for 1 month. Seven days wash out period will be conducted prior study starts. The evaluation will be conducted before, two weeks after treatment starts, and at the end of the study.
15732606|NCT05004090|Diagnostic Test|DNA methylation analysis|Genomic DNA will be extracted from 0.4 ml aliquots of each saliva sample using the kit manufacturer's suggested protocol, quantified with Qubit 2.0 (Invitrogen), and stored at -20°C. Aliquots of 250 ng of each DNA will be edited for methylation analysis with the EZ DNA Methylation Lightning kit (Zymo Research). Amplification of samples and their preparation for NGS sequencing will be performed as described. Samples will be sequenced on NextSeq 500 (Illumina). Individual processed sequences (PE reads) will be independently aligned to reference sequences using a parallel Smith-Waterman algorithm. Only reads that consistently align to the same reference sequence will be retained. At each CpG site in each analyzed sequence, the frequencies of the four bases will be evaluated and tabulated.
15732607|NCT05004090|Diagnostic Test|Proteomics analysis|Urine samples are collected using non-invasive methods and are prepared according to a procedure preparatory to quantitative recovery of exosomes: once thawed and centrifuged at 17,000 x g for 10 min at 4°C, the recovered supernatants are separated and centrifuged at 200,000 x g for 1 hr at 4°C. Exosome pellets are separated, washed repeatedly and resuspended in buffer (NH4HCO3, 0.1 mM ph=7.8). Protein concentration is estimated with the SPNTM Protein Assay kit and each sample (50 ± 0.5 μg protein) is digested with trypsin using a 1:50 (w/w) enzyme/substrate ratio at 37 °C over night (o/w). A second tryptic digestion is performed with an enzyme:substrate ratio of 1:100 (w/w) for 4h. Digested samples, centrifuged at 13,000 × g for 10 min, are purified and concentrated using PepClean C-18 columns. The samples obtained are analyzed by reversed-phase liquid chromatography coupled to high-resolution mass spectrometry.
15732608|NCT05004090|Diagnostic Test|Still Face Paradigm|During an observational session, a short video recording of the mother-child interaction of approximately 10 minutes will be made in a semi-structured setting to assess the child's emotional regulation and social behavior. The interaction will be structured in 5 different phases according to the Still Face paradigm (Tronick et al., 1978): Play, Still#1, Reunion#1, Still#2, Reunion#2. Play: Mothers will be invited to interact with their babies for 10 minutes; Still: mothers will be asked to remain still while maintaining an unresponsive expressionless face and not to smile, touch, or talk to the child for 2 minutes (Still#1: 2 minutes; Still#2: 2 minutes); Reunion: mothers will be asked to resume the play activity with their own for an additional 2 minutes (Reunion#1: 2 minutes; Reunion#2: 2 minutes).
15732609|NCT05004077|Drug|AMIODARONE|Assess the effectiveness of different dosing strategies of amiodarone.
15732610|NCT05004064|Drug|Acalabrutinib|Patients will receive acalabrutinib 100mg twice daily for up to six 28 day cycles. Patients can receive 100mg once daily for cycle 1, day 1 to day 7, according to the investigator's discretion.
15732611|NCT05004064|Drug|Rituximab|Patient will receive rituximab 375 mg/m2 IV on day 1 (+/- 3 days) of each cycle, for a maximum of 6 cycles
15732612|NCT05004051|Other|ViTAA Analysis|Imaging Analysis Software
15732613|NCT05004038|Biological|BCG Vaccine AJVaccines|Single intradermal injection of BCG Vaccine according to published Summary of Product Characteristics
15732614|NCT05004025|Device|Novocure Optune|Novacure Optune with Opdivo and Yervoy
15732615|NCT05004025|Drug|Opdivo|Novacure Optune with Opdivo and Yervoy
15732616|NCT05004025|Drug|Yervoy|Novacure Optune with Opdivo and Yervoy
15732617|NCT05004012|Device|Magnetically Controlled Capsule Endoscopy|This is a diagnostic device for gastric disorders used to diagnose mucosal abnormalities. In this study it will be evaluated for use in gastric motility.
15732618|NCT05003999|Device|HPC - SpeediCath ®|The investigators measure the time taken to perform intermittent catheterization using a 13 step pre-determined intermittent catheterization protocol using a hydrophilic catheter
15732619|NCT05003999|Device|Non-HPC - Self-Cath ®|The investigators measure the time taken to perform intermittent catheterization using a 13 step pre-determined intermittent catheterization protocol using a non-hydrophilic catheter; Lubrication jelly (MUKO ®, 3.5g package, Cardinal Health Canada Inc, Toronto, ON, Canada) was provided
15732620|NCT05003986|Drug|Sparsentan|Population 1: 800 mg Sparsentan
15732621|NCT05003986|Drug|Sparsentan|Population 2: 400 mg Sparsentan
15732622|NCT05003973|Behavioral|home-based anti-resistance exercise|It is a 12-week, middle-level, home-based, anti-resistance exercise. Exercise was recommended 1-2 times per day for 15-20 mins per session.
15732623|NCT05003973|Behavioral|usually care|The leaflet of the lymphedema self-care, including skin care and manual lymphatic drainage
15732624|NCT05003960|Biological|AlloRx|cultured allogeneic adult umbilical cord derived mesenchymal stem cells
15732625|NCT05003947|Biological|AlloRx|cultured allogeneic adult umbilical cord derived mesenchymal stem cells
15732626|NCT05003934|Biological|AlloRx|cultured allogeneic adult umbilical cord derived mesenchymal stem cells
15732627|NCT05003921|Biological|AlloRx|cultured allogeneic adult umbilical cord derived mesenchymal stem cells
15732628|NCT05003908|Biological|AlloRx|cultured allogeneic adult umbilical cord derived mesenchymal stem cells
15732632|NCT05003882|Other|Commercially available, orally ingestible CBD product|botanically-derived CBD extract product
15732633|NCT05003869|Procedure|Scar tissue is removed|The patients were divided into two groups according to whether the scar tissue was removed during TCRA operation: study group: resection of uterine scar tissue during TCRA operation;In the control group, the scar tissue covering the anterior, posterior and lateral walls of the uterine cavity was ploughed longitudinally into several narrow strips using needle-like electrodes, and the scar tissue was not excised.
15732634|NCT05003856|Other|Quality-of-Life Assessment|Ancillary studies
15732635|NCT05003856|Procedure|Radiofrequency Ablation|Undergo RFA
15732636|NCT05003843|Device|Indigo Aspiration System|Indigo Aspiration System
15732678|NCT05003531|Drug|IBI112 dose 2|Participants will receive placebo or dose 2 IBI112 SC
15732679|NCT05003531|Drug|IBI112 dose 4|Participants will receive placebo or dose 4 IBI112 SC
15732637|NCT05003830|Device|PET/MR|18F-FDG, 11C-PIB and 18F-PM-PBB3 injection are radiopharmaceuticals used for positron emission tomography (PET) imaging. 18F-FDG dose is about 3.7-5.4 MBq/kg (0.1 -0.15 mCi/kg), and used in the assessment of brain glucose metabolism. 11C-PIB dose is about 5-10mCi, and used in the assessment of amyloid deposition. 18F-PM-PBB3 dose is about 5-10mCi, and used in the assessment of tau deposition. Use PET/MR equipment for simultaneous PET and MR collection.
15732638|NCT05003817|Device|Percutaneous left ventricular unloading|Percutaneous left ventricular unloading involves the placement of a mechanical pump which draws blood from the left ventricle and returns it into the aorta at flow rates approaching native cardiac output.
15732641|NCT05003778|Other|Traditional equipment resistance training|Participants will undergo 6 weeks of traditional equipment resistance training
15732642|NCT05003778|Other|Minimal equipment resistance training|Participants will undergo 6 weeks of minimal equipment resistance training
15732643|NCT05003778|Other|Blood flow restriction training|Participants will undergo 6 weeks of blood flow restriction training
15732644|NCT05003765|Drug|Bupivacaine 0.25% Injectable Solution|Injection of Bupivacaine 0.25% Injectable Solution for SPIP Nerve Block.
15732645|NCT05003765|Drug|Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg|Injection of Bupivacaine 0.25% Injectable Solution for SPIP Nerve Block. Addition of 200mg of magnesium sulfate as adjuvant.
15732646|NCT05003765|Drug|Bupivacaine 0.25% Injectable Solution, Magnesium Sulfate 200 mg, Buprenorphine 300 mcg|Injection of Bupivacaine 0.25% Injectable Solution for SPIP Nerve Block. Addition of 200mg of magnesium sulfate and 300 mcg buprenorphine as adjuvants.
15732647|NCT05003752|Radiation|External beam radiation therapy, High-dose-rate brachytherapy|Combined hypofractionated external beam radiation therapy (EBRT) plus high dose-rate brachytherapy (HDR-BT) schedule (total dose of EBRT 36 Gy/ in 12 fractions of 3 Gy plus HDR-BT with a total physical dose of 14 Gy in a single fraction)
15732648|NCT05003752|Drug|Goserelin 10.8 mg|Androgen deprivation will be administered based on NCCN guidelines in patients with unfavorable intermediate/high risk organ-confined prostate cancer
15732649|NCT05003739|Procedure|Hip arthroplasty with Logica Mirror femoral stem|Total or partial hip arthroplasty with implant of Logica Mirror femoral stem
15732650|NCT05003726|Procedure|non-pharmacological treatment|This is a pragmatic setting, and specific intervention is not determined prior to the study. Non-pharmacological treatment including Korean medicine, such as acupuncture, electroacupuncture and chuna, etc, will be chosen by professional physician according to the medical condition of each subject.
15732651|NCT05003726|Procedure|pharmacological treatment|This is a pragmatic setting, and specific intervention is not determined prior to the study. The pharmacological treatment will be chosen by professional physician according to the medical condition of each subject.
15732652|NCT05003713|Drug|CORT125236|CORT125236 Lipid Capsule Formulation 10-60 mg for oral administration
15732653|NCT05003713|Drug|Placebo matching CORT125236|Placebo matching CORT125236 Lipid Capsule Formulation 10-60 mg for oral administration
15732654|NCT05003713|Drug|Prednisone|Prednisone tablet 25 mg (20 mg + 5 mg tablets) for oral administration
15732655|NCT05003700|Procedure|Hepatic arterial infusion chemotherapy|administration of oxaliplatin and raltitrexed via the tumor feeding arteries every 3 weeks.
15732656|NCT05003700|Drug|Lenvatinib|8 mg once daily (QD) oral dosing.
15732657|NCT05003700|Drug|Camrelizumab|200mg intravenously every 3 weeks.
15732658|NCT05003687|Drug|Lu AG06474|solution, orally (Parts A and B)
15732659|NCT05003687|Drug|Placebo|solution, orally (Part A only)
15732660|NCT05003674|Device|Focused stimulation strategy|Investigational focused stimulation strategy
15732661|NCT05003674|Device|ACE stimulation strategy|Standard of care stimulation strategy
15732662|NCT05003661|Behavioral|Parents' Voice|the intervention is recording of parents voice of reading children's book.
15732663|NCT05003648|Drug|Pramipexole|Participants will be started on 0.125 mg pramipexole for the first week. If this dose is well tolerated but not effective, the dose can be increased to 0.25 mg for the following week. If this dose is well tolerated but not effective, the dose can be further increased to 0.5 mg for the remainder of the 2-month period.
15732664|NCT05003648|Drug|Placebo|Matching placebo
15732665|NCT05003635|Device|EVEBRA device|Wear 2 weeks pre-operatively for a total duration of 200 hours. Wear 2 weeks post-operatively for 10 hours a day.
15732666|NCT05003622|Drug|Encorafenib|oral capsule
15732668|NCT05003596|Drug|Methylprednisolone Tablet|Subjects will take a quantity 21 4mg tablets over a 6 week taper.
15732669|NCT05003596|Other|Standard Mobilization Treatment|standard treatment of hand injuries with focus on mobilization. No anti-inflammatory medications. Pain management via Tylenol or narcotics if deemed necessary.
15732670|NCT05003583|Behavioral|Speaking after viewing pictures with negative valence|10 age-appropriate pictures from the International Affective Picture System (IAPS; Lang, Bradley & Cuthbert, 2005) will be shown to participants. These pictures are classified as high arousal, negative valence stimuli. Participants will be asked to repeat a simple phrase between picture presentations.
15732671|NCT05003583|Behavioral|Speaking after viewing blank screen pictures|A blank screen will be shown to participants in place of pictures. This condition is classified as low arousal, neutral valence. Participants will be asked to repeat a simple phrase between blank screen picture presentations.
15732672|NCT05003570|Drug|Remifentanil|Dosage forms and strengths: 3 mL Vial/1 mg lyophilized powder. Manufacturer: Yichang Humanwell Pharmaceutical Co.,Ltd
15732673|NCT05003570|Drug|Fentanyl|Dosage forms and strengths: 50 mcg/mL Fentanyl base/10 mL ampules. Manufacturer: Yichang Humanwell Pharmaceutical Co.,Ltd
15732674|NCT05003557|Other|Questionnaire administration|"3 different questionnaires are going to be administered to each participant,
~concerning the current health situation
~the SF 36
~the IPQ-R questionnaire"
15732680|NCT05003531|Drug|IBI112 dose 1|Participants will receive placebo or dose 1 IBI112 SC
15732681|NCT05003531|Drug|IBI112 dose 3|Participants will receive placebo or dose 3 IBI112 SC
15732682|NCT05003531|Drug|placebo|Participants will receive placebo SC
15732683|NCT05003518|Behavioral|ParentText|ParentText delivers content, aligning with children's developmental stages (0-23 months, 2-9 years, 10-17 years). ParentText content is delivered through text messages, images, audio and video for parents/ caregivers and their children. Parents receive parenting content surrounding three themes: 1) relationship building by spending time together, 2) positive reinforcement, 3) stress reduction for parents and caregivers. Further supportive content is available for parents of children living with disabilities, child development, online child safety, talking about COVID-19 with children, family budgeting, family harmony, helping with schoolwork and sexual violence prevention.
15732684|NCT05003505|Other|Follow up|Participants will be followed up at 6, 12 and 24 months with the test of enous blood, vaginal secretions, faeces, and cervical exfoliated cells.
15732685|NCT05003492|Combination Product|Combination therapy plus Standard therapy|"Methylene Blue 1 mg/kg water solution. Participants will orally receive Methylene Blue solution of 1 mg/kg concentration one time if any. After 3 hours of Methylene Blue administration irradiation of chest using 650 nm laser source with 18 J/cm^2 energy dose will be performed.
~Patients will be administered study medication (Inhaled 100-150 mg phenformin per day; or, if broken into 3 doses/day, 30-50 mg/dose. this dose well be once daily for 5 days, for a maximum of 7 days for those who remain hospitalized.
~Patients will receive an Enriched Grape Juice containing 234.5 mmol microcrystalline KCl (a total of 6000 mg of K in 2 EGJ, but split into 2 intakes daily)
~Patients received will receive Zinc gluconate capsule 15 mg x 2 per day during 14 days"
15732686|NCT05003492|Radiation|Photodynamic therapy|After 3 hours of Methylene Blue administration irradiation of chest using 650 nm laser source with 18 J/cm^2 energy dose will be performed.
15732687|NCT05003492|Drug|Standard therapy|Infected patients will receive the standard therapy for COVID-19 for 14 days
15732688|NCT05003479|Biological|SARS-CoV-2 Vaccine (Vero Cells), Inactivated|2 doses of SARS-CoV-2 Vaccine (Vero Cells), Inactivated should be administered as an intramuscular injection into the lateral deltoid of the upper arm with a 28-day interval.
15732689|NCT05003479|Biological|Placebo|2 doses of Placebo should be administered as an intramuscular injection into the lateral deltoid of the upper arm with a 28-day interval.
15732690|NCT05003466|Biological|SARS-CoV-2 Vaccine (Vero Cells), Inactivated|"2 doses of SARS-CoV-2 Vaccine (Vero Cells), Inactivated with a 28-day interval constitute a primary immunization course. The third dose on 6 months after primary course is the booster dose.
~Administer as an intramuscular injection into the lateral deltoid of the upper arm."
15732691|NCT05003466|Biological|Placebo|2 doses of Placebo should be administered as an intramuscular injection into the lateral deltoid of the upper arm with a 28-day interval.
15732692|NCT05003453|Drug|1.5% Palmitoylethanolamide (PEA) sold as Levagen+|A topical cream containing 1.5% PEA applied to the affected site 2-3 times daily, liberally to coat and cover affected area.
15732693|NCT05003453|Drug|Placebo Comparator|A comparator placebo topical moisturiser cream (an unscented moisturising base cream) applied to the affected site 2-3 times daily, liberally to coat and cover affected area.
15732694|NCT05003440|Drug|NNC0385-0434|Participants will get 1 tablet (oral use) of NNC0385-0434 per day for 10 days in either 15, 40 or 100 mg
15732695|NCT05003440|Drug|Placebo|Participants will get 1 tablet (oral use) of placebo per day for 10 days
15732696|NCT05003427|Drug|68Ga-FAPI-04|68Ga-FAPI-04 were injected into the patients before the PET/CT scans
15732697|NCT05003414|Device|GMK Sphere cementless Knee Replacement|Performance of Total Knee Arthroplasty (TKA) with GMK Sphere cementless Knee Replacement
15732699|NCT05003388|Biological|AlloRx|cultured allogeneic adult umbilical cord derived mesenchymal stem cells
15732700|NCT05003375|Behavioral|High-challenging cognitive protocol to provoke stress and (cognitive) fatigue|"Baseline measurement is done in two parts: 1) resting for five minutes (no talking, no movement) and 2) speaking at normal pace (2 minutes).
~This is immediately followed by a measurement of the physiological response variables during the testing, in which the following protocol is performed in the order presented: 1) SDMT-NBack task-SDMT*-NBacktask**, 2) NBack task-SDMT-NBack task-SDMT. Participants will run either sequence to check for effects of the previous testing. During the conduct of the study, it will be ensured that half of the participants in each group followed Sequence 1 and the other half of the group followed Sequence 2.
~During all these measurements, the participant will sit at a table with a computer on which the tests are performed.
~*SDMT: Symbol Digit Modalities Test: see description in outcome measures
~**N-Back Task: see description in outcome measures"
15732701|NCT05003362|Behavioral|ACT|mindfulness intervention for patients with pain/migraine
15732708|NCT05003336|Drug|Xiangshao Granules|dissolve 1 sachet (4 g) in water to be drank 3 times a day after meal for 8 weeks
15732709|NCT05003336|Drug|Xiangshao Granules Placebo|Xiangshao Granules Placebo
15732714|NCT05003297|Other|hemogram inflammatory parameters|Neutrophil to Lymphocyte Ratio (NLR) and Platelet to Lymphocyte Ratio (PLR)
15732715|NCT05003284|Device|acupressure wristband|acupressure after surgery
15732716|NCT05003284|Device|placebo wristband|acupressure after surgery
15732717|NCT05003271|Other|Exercise program (virtual/remote)|Intervention (8 weeks): using the participants' initial assessment and personal characteristics, the therapist will provide personalized recommendations (e.g. maximum heart rate, minimum SpO2), explain the educational materials, and instruct patients on safety precautions.
15732718|NCT05003258|Device|Intravitreal injection of Dexamethasone implant|Intravitreal injection of Dexamethasone implant
15732719|NCT05003245|Drug|HLX04-O，recombinant anti-vascular endothelial growth factor (VEGF) humanized monoclonal antibody ophthalmic injection|0.05mL solution at a 4-week interval for intravitreal injection
15732720|NCT05003245|Drug|Lucentis|0.05mL solution at a 4-week interval for intravitreal injection
15732721|NCT05003232|Device|Near-infrared spectroscopy (NIRS) and ICM+|The intervention group will be given continuous NIRS and invasive blood pressure monitoring at same time. The correlation curve between the brain oxygenation index or the brain hemoglobin index (ORI/THx) and the blood pressure will be obtained through continuous monitoring. According to the correlation curve, the optimal blood pressure will be determined which provides the optimal CPP. Then the goal of blood pressure (within 5 mmHg of CPPopt) will be maintained as the target of blood pressure management for the intervention group during ICU stay.
15732722|NCT05003206|Other|Functional magnetic resonance imaging|Preoperative and postoperative functional magnetic resonance imaging (fMRI) scanning. fMRI is a new neuroimaging method. Its principle is to use magnetic resonance imaging to measure the changes of hemodynamics caused by neuronal activity.
15732723|NCT05003206|Device|Deep Brain Stimulation|For PD patients treated with DBS, the neurologist will turn off the stimulator before MRI scan
15732724|NCT05003193|Device|pedometer|2000 steps per day in 20 minutes for 90 days, guided by a pedometer after a kidney transplantation
15732725|NCT05003180|Procedure|Surgical stabilization with posterior fixation|The surgical stabilization can be either open or minimally invasive. The procedure will be posterior fixation with pedicle screws and rods. Both short and long segment fixation are allowed in the study. It is up to the treating surgeon to decide on fusion or decompression. If feasible, pedicle screws are inserted in the fractured vertebra.
15732726|NCT05003167|Device|Expiratory Muscle Strength Training (EMST-150)|All participants will forcefully breathe out into an Expiratory Muscle Strength Training device (EMST-150) 25 times per day for 6 weeks. The EMST device will be set at a moderate intensity level (50% of each participant's maximum expiratory pressure).
15732727|NCT05003154|Other|Digitalized management|"In addition to conventional management, Patients also receive digitalized management, which provides personalized guidance in diet, excercise, prenatal visit, blood glucose monitoring,etc., from artificail intelliegence (AI) supevised by obstetricians, through a smartphone application and some werable devices (like sports bracelet).
~The pivotal AI are based on clinical experience from obstetricians, therapeutic principle from official Guidelines and abundant data in previous work, and it will works under strict supervision."
15732728|NCT05003141|Drug|PSB202|PSB202 is an antibody combination product comprised of two full-length monoclonal antibodies, PSB102 and PSB 107, respectively targeting CD20 and CD37. PSB202 is manufactured to work as a single product.
15732729|NCT05003128|Device|LED screen (InnoLux, Taiwan)|Participants watch a short movie on an LED screen (InnoLux, Taiwan) for 15 minutes in a bright room. The viewing distance was approximately 1.5 meters.
15732731|NCT05003102|Drug|Dexmedetomidine Hydrochloride - Cycling|Dexmedetomidine Hydrochloride infusion at 0.5 mcg/kg titrated to 0.3 mcg/kg/hr up to a max drip rate of 2 mcg/kg/hr.
15732732|NCT05003102|Drug|Fentanyl - PICU Standard|fentanyl infusion at 1 mcg/kg/hr up to a max drip rate of 5 mcg/kg/hr
15732733|NCT05003102|Drug|Dexmedetomidine Hydrochloride - PICU Standard|Dexmedetomidine Hydrochloride infusion at 0.3 mcg/kg titrated to 0.5 mcg/kg/hr up to a max drip rate of 2 mcg/kg/hr
15732734|NCT05003089|Drug|BAY1834845|Tablet, oral.
15732735|NCT05003089|Drug|BAY1830839|Tablet, oral.
15732736|NCT05003089|Drug|Prednisolone|Tablet, oral.
15732737|NCT05003089|Drug|Placebo|Tablet, oral.
15732738|NCT05003076|Drug|Methamphetamine|Participants will be given 20 mg of Methamphetamine.
15732739|NCT05003076|Drug|Placebo|Participants will be given a placebo capsule that will only contain lactose.
15732740|NCT05003063|Drug|Donepzil|Test
15732741|NCT05003063|Drug|Placebo oral tablet|Test
15732742|NCT05003050|Other|Meditation|Holistic natural therapy
15732743|NCT05003050|Other|Pranic Healing|Energy therapy
15732744|NCT05003037|Drug|Surufatinib,Toripalimab,Pemetrexed,Carboplatin/Cisplatin|Surufatinib at the dose determined in phase safety lead-in，250 mg，qd，po，every 3 weeks(q3w) ; Toripalimab at the dose 240mg，iv, d1, given every 3 weeks (q3w); Pemetrexed at the dose 500 mg/m2，iv，d1，given every 3 weeks (q3w); Carboplatin at the dose AUC=5~6，iv，d1，given every 3 weeks (q3w) or Cisplatin at the dose 75 mg/m2，iv ,d1，q3w; Maintenance treatment：After the end of the first-line treatment, patients with CR, PR, and SD can continue to maintenance treatment with Surufatinib RP2D，d1-21，q3w＋Toripalimab 240mg，d1，q3w+Pemetrexed 500mg/m2，d1，q3w was taken until the disease progressed.
15732745|NCT05003024|Device|TOF SCAN|"For each included patient, 2 monitorings (TOF Scan and ITF device) will be placed, one on each hand.
~Once 2 contractions of the adductor pollicis muscle will be observed on the TOF Scan side following train of four stimulation, 2 mg/kg sugammadex will be injected. Train of four ratio (delivered every minute) will be recorded.
~This sequence (tetanus 100 Hz followed by tetanus 50 Hz) will be repeated 5 times For each tetanus stimulation, the ratio between the residual force and the maximum force generated by the adductor pollicis muscle will be recorded (this ratio illustrates the fade phenomenon). At the end of this period lasting 23 minutes after sugammadex administration, anesthetic drug delivery will be stopped and the patient wil be allowed to recover."
15732746|NCT05003024|Device|ITF|"For each included patient, 2 monitorings (TOF Scan and ITF device) will be placed, one on each hand.
~On the ITF device side, 3 minutes after sugammadex administration, a tetanus 100 Hz stimulation will be done followed 2 minutes later by a tetanus 50 Hz stimulation.
~This sequence (tetanus 100 Hz followed by tetanus 50 Hz) will be repeated 5 times For each tetanus stimulation, the ratio between the residual force and the maximum force generated by the adductor pollicis muscle will be recorded (this ratio illustrates the fade phenomenon). At the end of this period lasting 23 minutes after sugammadex administration, anesthetic drug delivery will be stopped and the patient wil be allowed to recover."
15732747|NCT05003011|Device|Cardiospire|Non-invasive hemodynamic monitoring
15732748|NCT05002998|Drug|Teprotumumab|"Teprotumumab is a fully human anti-IGF-1R mAb. Teprotumumab will be provided in single-dose 20-mL glass vials as a freeze-dried powder containing, in addition to the drug substance, 20 mmol/L histidine-histidine chloride, 250 mmol/L trehalose and 0.01% polysorbate 20 (w/w).
~Prior to administration, each vial containing 500 mg teprotumumab freeze-dried powder will be reconstituted with 10 mL of sterile water for injection. The resulting solution will have a concentration of 47.6 mg/mL teprotumumab-trbw antibody. The reconstituted teprotumumab solution must be further diluted in 0.9% (w/v) sodium chloride (NaCl) solution prior to administration"
15732749|NCT05002998|Drug|Placebo|Placebo will consist of a normal saline (0.9% NaCl) solution and will be administered in 100 mL or 250 mL infusion bags, as appropriate, per weight-based dosing volumes.
15732750|NCT05002985|Behavioral|walking group led by a community organizer|Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market.
15732751|NCT05002972|Behavioral|walking group led by a community organizer|Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market.
15732752|NCT05002959|Device|Anatomic TESS V3|Implantation of the T.E.S.S.® V3 Modular Total Shoulder System, Anatomic configuration.
15732753|NCT05002959|Device|Reverse TESS V3|Implantation of the T.E.S.S.® V3 Modular Total Shoulder System, Reverse configuration.
15732754|NCT05002946|Drug|SP-104|single oral dose
15732755|NCT05002946|Drug|Naltrexone Hydrochloride 50Mg Oral Tablet|single oral dose
15732756|NCT05002933|Drug|Insulin glargine 300 U/ml|Solution for injection Subcutaneous injection
15732757|NCT05002920|Procedure|alveolar bone grafting|the surgery of alveolar bone graft for alveolar defect in cleft patients
15732758|NCT05002907|Other|Questionnaire|After signing the informed consent sheet, a standardized face-to-face questionnaire will be conducted by the doctor, nurse or coordinator to collect socio-demographic data, lifestyle data, sex life and other potential risk factors and knowledge about viral hepatitis.
15732759|NCT05002907|Other|Biocollection|After answering the questionnaire, the nurse or the doctor will take a sample of capillary blood from the fingertip on the side of the distal phalanx of a middle or ring finger. The puncture site will be prepared by warming and massage to optimize blood flow and disinfected with a disposable 70% alcohol wipe. After drying, the puncture will be performed using a single use safety lancet. A total of 7 capillary blood spotswill be collected and deposited on the filter paper (each spot is about 50µL of capillary blood), 5 for the study and 2 for the biological collection.
15732760|NCT05002907|Other|Delivery of results|After receiving the individual biological analysis results, in coded form (results only identified by the anonymity number), at the investigation center and lifting the anonymity by the coordinator of the study in each study center (in Cayenne or Paramaribo depending the country where the inclusion took place) with the help of the correspondance list, the participants' results will be delivered to the referral doctor of each health centre and the infectious disease specialist responsible for each area of inclusion. All positive participants will be contacted if they do not spontaneously come to retrieve their results (within approximately 1 month after result's availability), and invited to come to the health centre to retrieve their results individually and be oriented towards the heathcare circuit.
15732761|NCT05002907|Other|Results and advices on transmission prevention methods|The results will be revealed by the health centre's doctor/infectiologist, individually and confidentially, with an explanation of the results and advices on transmission prevention methods.Non-immunized patients against HBV will be offered a status determination (Anti-HBs Ab quantification on whole blood sample) and if necessary a catch-up vaccination according to the national immunization schedule.
15732762|NCT05002907|Other|Confirmation of results on a blood test (In the event of a positive result)|In case of a positive result, the doctor will explain the need to confirm these results on a blood test, prescribe the initial assessment and take an appointment with the infectious disease specialist. He will guide the patient towards accompaniment for the opening of medical coverage rights if necessary and support by an association if desired.
15732763|NCT05002907|Other|Information for care|A document with all contact information for a comprehensive and specialized care (professionals and associations for access to medical coverage and support, associations proposing support, general practitioners and specialists) will be given to positive participants. Patient monitoring and treatment will be carried out according to the national guidelines in each country.
15732764|NCT05002907|Other|Monitoring and treatment|Consequently, all positive participants will be able to be monitored and treated by a specialist of the disease. They will give post-test counselling and will conduct patient follow-up and treatment according to the usual standards of care of each country.
15732765|NCT05002894|Other|Pilates exercises|Pilates exercises for flexibility and stability
15732766|NCT05002894|Dietary Supplement|medical standard care for fatigue|supplements and medical care
15732769|NCT05002868|Drug|RP12146|starting dose of 100 mg QD
15732770|NCT05002855|Other|Enhanced Recovery After Surgery (ERAS)|Multidisciplinary approach to perioperative care.
15732771|NCT05002842|Behavioral|LovingKindess Meditation|Participants will have access to a recording of a script to guide them through meditation
15732772|NCT05002829|Other|Restricted Duration of SOC Antibiotic Use|Standard of Care Antibiotic use will be restricted to none or up to 24 hours of post-operative antibiotics.
15732773|NCT05002829|Other|Liberal Duration of SOC Antibiotic Use|Standard of Care Antibiotic use will be permitted for 24 hours or up to 4 days of post-operative antibiotics.
15732776|NCT05002803|Other|Otago Exercise Program|A Home-based Exercise Program to improve strength and balance and prevent falls.
15732777|NCT05002790|Diagnostic Test|Data collection group|"Magnetic resonance imaging (MRI) allows measurement of the axes described to suggest which head and neck position would provide best anatomical alignment to reduce anterior impingement.
~All the MRI scans will be conducted using 3.0 Tesla (Optima 750w, GE Medical, Milwaukee, WI, USA) using the cervical spine section of the coil. T2-weighted images in the sagittal plane will be acquired using a fast recovery fast spin echo (FRFSE) technique. The scans will take around two and half minutes and a member of the anaesthetic investigator team will be present to facilitate positional changes and maintain consistency. MRI scanning will be performed in following 3 head and neck positions:
~Neutral position, Sniffing position and the Extension position."
15732778|NCT05002777|Drug|rilzabrutinib|Pharmaceutical form: Tablet Route of administration: Oral
15732779|NCT05002751|Other|UCSD Vaginal Dilator Questionnaire|14 question survey
15732780|NCT05002751|Other|EORTC Sexual Health Questionnaire|22 question survey
15732781|NCT05002738|Drug|Desogestrel and Ethinyl Estradiol Tablets|Combined oral contraceptive pill
15732782|NCT05002725|Drug|Lidocain|300mg (20ml) will be injected
15732783|NCT05002712|Other|Heavy resistance training|Their training program included 4 resistance exercises with heavy weight lifting of the leg muscles. 3 sets of 6-8 repetitions of 80-90 % of maximal load were performed with a barbell squat (range of 0 to 90º knee flexion), lying leg curl, seated calf raises, and leg extension. The rests between the sets and the exercises lasted 5 minutes.
15732784|NCT05002712|Other|Contrast strength training|Their resistance training program contained the same exercises as the high resistance training group, but with different intensity. Athlete performed each exercise for the first time with 5-7 reps with 80 % of the 1RM load followed by 15-20 reps with 40 % of the maximal load to complete the 3 sets for each exercise. The rest period between series was 60 seconds and the rest period between exercises was 5 minutes. For example, 5 heavy barbell squats followed immediately by 20 squat with lighter weight to complete 3 sets.
15732785|NCT05002712|Other|Elastic resistance training|During the intervention, the group conducted a 'elastic resistance training' with the same muscle groups. External resistance was provided by blue thera-band latex-free exercise bands in this training. Each exercise was performed three times for a total of 15-25 repetitions. In between sets, a 5-minute rest period was given and there was a 25-second rest period in between exercise performance. The intensity of each exercise was increased with the black thera band at the midpoint (start of week 7) of the training. The following figure shows the resistance of the blue and black bands to 100 percent elongation. Following figure shows the resistance offered by blue and black band at 100% elongation.
15732786|NCT05002699|Diagnostic Test|Alzheimer's disease CSF biomarkers|Measurement of amyloid beta peptide 1-42, amyloid beta peptide 1-40, and total tau in cerebrospinal fluid.
15732787|NCT05002686|Drug|Sintilimab|200 mg Q3W on Day 1 by IV infusion
15732788|NCT05002686|Drug|Albumin-Paclitaxel|200 mg/m^2 Q3W on Day 1 by IV infusion
15732789|NCT05002686|Drug|Capecitabine|1000 mg/m^2 orally according to Body Surface Area (BSA) BID Q3W on Days 1-14
15732790|NCT05002686|Drug|Oxaliplatin|130 mg/m^2 Q3W on Day 1 by IV infusion
15732791|NCT05002686|Radiation|Radiation|Radiotherapy for gastric lesions and high-risk areas of retroperitoneal lymph node before sugery, 45Gy*25.
15732792|NCT05002686|Procedure|Radical gastric cancer surgery|Radical gastric cancer surgery with D2 lymph node dissection
15732793|NCT05002673|Device|DENTAL LOCAL ANESTHESİA|doing local and topical anesthesia with two different device
15732794|NCT05002660|Behavioral|Group 1 (Intervention)|The investigators will evaluate the efficacy of the CC curriculum in a 24-months community-based randomized controlled trial. They will compare changes in CVD-related anthropometric, physiologic, behavioral, and psychosocial parameters between subjects in 6 intervention and 6 control communities.
15732795|NCT05002660|Behavioral|Group 2 (Control)|Group 2 will be offered the same activities as Group 1 after the conclusion of the research study.
15732796|NCT05002647|Other|NO intervention|There is no intervention
15732797|NCT05002634|Dietary Supplement|undenatured collagen type II (UCII) supplement|The undenatured collagen type II (UCII) supplement 40 mg will be taken once daily for 2 months.
15732798|NCT05002608|Behavioral|Health Insurance Navigation Program|The program will be delivered via videoconferencing by a navigator over a 2-month period and will consist of 4 sessions. The navigation intervention sessions will be as follows: Session 1- Learning About Survivorship Healthcare Needs; Session 2- Learning About Your Plan in Relation to Policy; Session 3- Navigating One's Own Plan and Overcoming Obstacles; Session 4- Managing Care Costs.
15732799|NCT05002595|Drug|H. pylori eradication|Antimicrobial agents for H. pylori eradication
15732800|NCT05002569|Biological|Nivolumab|Specified dose on specified days
15732801|NCT05002569|Biological|Relatlimab|Specified dose on specified days
15732802|NCT05002556|Diagnostic Test|Urinary Biomarkers|Prior to each examination, participating patients will produce a urine sample of approximately 20 to 40 ml in total dedicated to the determination of the marker proposed by your urologist, done by medical analysis laboratory. At each follow-up endoscopic examination scheduled in the patient's personalized care plan, the investigating urologist will record its date and endoscopic findings (white light bladder fibroscopy). The name and result of the urine test will also be recorded by the investigating urologist. The performance of the test will be evaluated from these data by calculating sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) and by means of an analysis of variance (ANOVA) to explore possible differences within the test by tumor grade and stage, and according to previous endovesical treatments received
15732803|NCT05002530|Drug|Aerosolized All trans retinoic acid|Patients with Post COVID-19 Anosmia (Loss of Smell) will receive one dose daily of Aerosolized All trans retinoic acid in gradual doses increases from 0.2 mg/kg/day to 4 mg/kg/day as inhaled All trans retinoic acid therapy for 3 weeks.
15732804|NCT05002530|Drug|Placebo/Control|Patients randomized to this arm will also be instructed to take two of the softgels they received per day for 6 weeks. They will receive placebo vitamin A softgels that are indistinguishable from those containing aerosolized all-trans retinoic acid.
15732805|NCT05002517|Drug|Tociliziumab group|Tocilizumab is a humanized recombinant IgG1 monoclonal antibody to human interleukin-6 (IL-6) receptor, produced in Chinese hamster ovary cells by recombinant DNA technology.
15732806|NCT05002517|Drug|Methylprednisolone group|Methylprednisolone belongs to a group of medicines called corticosteroids (it works at the cellular level by reducing the production of substances that cause inflammation or allergy).
15732807|NCT05002504|Diagnostic Test|A series of questions were asked to the children's parents in a virtual questionnaire|A series of questions were asked to the children's parents in a virtual questionnaire on physical characteristics, previous health assessments and observations of their balance and coordination in front of their children
15732808|NCT05002504|Diagnostic Test|"neurobehavioral aspects of the students using the Battelle Developmental Inventory (BDI)"|"the school teachers examined neurobehavioral aspects of the students using the Battelle Developmental Inventory (BDI), which evaluates five areas of development (personal/social, adaptive, motor, communicative and cognitive) between 2 and 8 years of age. The results are assigned in age-adjusted percentages, classified as: low (0-49%), normal (50-79%) and high (80-100%). Low and high values are considered impairments in one or more of the areas evaluated. Evaluation of the Battelle scale was carried out before and after the therapy sessions."
15732809|NCT05002504|Procedure|Therapy sessions|Seven treatment sessions were carried out with the balance and coordination therapeutic exercise techniques (group 3) most frequently used for the treatment of these pathologies; seven sessions of craniosacral therapy (group 2) as corrective and preventive in possible alterations during infant neurodevelopment and finally seven sessions simulating craniosacral therapy on a placebo group (group 1) as a control of the treatments used.
15732810|NCT05002491|Other|High protein diet|Normal vs high protein dietary feeding
15732811|NCT05002478|Other|Prone positioning|Turn patient in prone position after surfactant administration.
15732812|NCT05002465|Drug|68Ga-PSMA-11|Injection of 68Ga PSMA-11
15732813|NCT05002465|Procedure|Positron Emission Tomography/Computed Tomography|PET/CT scan after 68Ga PSMA-11 injection
15732814|NCT05002452|Other|Search of factors predicting therapeutic effects and prognosis|There factors are collected in preoperative routine blood examination, preoperative radiological imaging and pathological examination.
15732816|NCT05002413|Diagnostic Test|Resistell AST|The Resistell AST is intended for rapid antibiotic susceptibility testing of most common clinically relevant Gram-negative bacteria causing bloodstream infections (BSI) (bacteremia). In the scope of this study, the device will be used to test the susceptibility of Gram-negative bacteria, in particular Escherichia coli, Klebsiella spp., and other Enterobacteriaceae to antibiotics: ceftriaxone, meropenem and ciprofloxacin and Pseudomonas aeruginosa to ceftazidime, meropenem, ciprofloxacin and piperacillin-tazobactam (combination antibiotic).
15732817|NCT05002387|Device|NanoScope™ Operative Arthroscopy (Arthrex, Inc)|Needle arthroscopy will be performed in the operating room to visual the medial, lateral, and patellofemoral compartments prior to undergoing either unicompartmental or total knee arthroplasty
15732818|NCT05002374|Other|Vestibular rehabilitation with optokinetic stimulation|Vestibular rehabilitation incorporated with optokinetic stimulation in virtual reality environment for five consecutive days
15732819|NCT05002374|Other|Vestibular rehabilitation|Customized vestibular rehabilitation for five consecutive days
15732820|NCT05002361|Drug|Dexamethasone|24 mg intravenous Dexamethasone (6 ml)
15732821|NCT05002361|Drug|Isotonic saline|6 ml of isotonic saline
15732889|NCT05001854|Drug|Fludrocortisone|100 μg every 6 hours of fludrocortisone per os
15732890|NCT05001854|Drug|Placebo|100 μg every 6 hours of placebo per os
15732891|NCT05001841|Procedure|Lung Transplantation|Double lung transplant
15732822|NCT05002348|Device|Laser acupoint stimulation(Laser pen)|Select 5-7 acupuncture points according to physical fitness. Each acupoint is performed once a day. The acupuncture point stimulation process takes about 3-5 minutes. The patient wears goggles and observes the patient's vital signs (blood pressure, heartbeat and blood oxygen) with a physiological monitor. , If the patient has any discomfort, the procedure will be stopped for a maximum of 10 days.
15732823|NCT05002335|Device|Medacta Shoulder System|Performance of Total Shoulder Arthroplasty (anatomic/reverse) with Medacta Shoulder System
15732824|NCT05002322|Other|Systems Analysis and Improvement Approach|"Intensive phase: district MOH supervisors receive a one-week training on SAIA-HTN. The first year of implementation will be mentored by INS study personnel who will accompany and support district MOH supervisors as they implement at the facility level. Over the first week of each iterative cycle, facility teams populate and interpret the HCAT, develop process maps, define one to two micro-interventions and indicators to monitor these modifications. Facility teams receive bi-weekly mentorship visits by district supervisors and study personnel for the first two months, followed by monthly visits throughout intensive implementation.
~Sustainment phase (zero, one or two years, depending on implementation wave allocation): district supervisors will independently lead implementation, with financial support for travel to clinics and to hold meetings, but without intensive support from study personnel."
15732825|NCT05002309|Behavioral|Cognitive-Behavioural Therapy|"20 sessions of individual CBT are offered over 16 weeks, conducted 1-on-1, with a trained and supervised therapist. Participants will learn about the cognitive, behavioural, emotional, and environmental factors which contribute to maintaining their depression. They will apply skills to interrupt unhelpful cognitive and behavioural patterns and engage in guided exploration to improve self-understanding. CBT is a structured and collaborative treatment. Weekly homework will be used to maximize opportunities for practice and consolidation of new skills. The individual sessions can be combined with optional family/parent/partner sessions, depending on the situation and preferences of the participant. All sessions will be video-recorded to allow high-quality supervision, fidelity- and quality-assurance. This corresponds to evidence available for CBT for adolescents and young adults that is established as the best practice through rigorous trials."
15732826|NCT05002309|Drug|Antidepressant medication|The choice of antidepressants follows best-established evidence for treating depression in adolescents and young adults. We will offer treatment with fluoxetine, starting at 10mg a day, increasing to 20mg a day after 1 week if tolerated; a protocol established as safe and effective in adolescents and adults in multiple trials. Additional increases to 40 or 60mg will be possible based on positive effects and side-effects and clinical judgement, as recommended in this age group. In cases of intolerance or adverse reaction to fluoxetine, we will switch to sertraline (25-200mg) or escitalopram (5-20mg), two antidepressants licensed by the FDA for major depressive disorder in adolescents. Treatment will be optimized over 16 weeks, a time-frame comparable to the CBT arm. Pharmacotherapy will be managed and prescribed by qualified psychiatrists when starting treatment and reviewed after 1 week, 2 weeks and then in 2-weekly intervals for the remainder of the 16 weeks acute treatment period.
15732827|NCT05002296|Procedure|upper cervical manipulation|rotatory upper cervical manipulation to both sides. The treatment program was conducted for twelve sessions (three sessions per week). Assessment procedures were performed before and after treatment through visual analogue scale (VAS)
15732828|NCT05002283|Other|patient specific guide|harvesting palatal free gingival graft using the patient specific guide
15732829|NCT05002270|Drug|JAB-21822 (KRAS G12C inhibitor)|Administered orally
15732830|NCT05002270|Drug|JAB-21822 (KRAS G12C inhibitor)|Administered orally
15732831|NCT05002270|Drug|JAB-21822 (KRAS G12C inhibitor)|Administered orally
15732832|NCT05002270|Drug|Cetuximab (EGFR inhibitor)|Administered IV
15732833|NCT05002257|Other|music therapy|Patients included in the intervention arm with music therapy will choose among 3 possible music: music from elsewhere, classical music, today's music. These 3 music thearpy will have an identical duration of 20 minutes.
15732834|NCT05002257|Other|No music therapy|Usual care
15732835|NCT05002244|Drug|CTL0801 (Azilsartan)|CTL0801 (Azilsartan), single dose, daily, repeated oral administration
15732836|NCT05002244|Drug|CTL0802 (Rosuvastatin)|CTL0802 (Rosuvastatin), single dose, daily, repeated oral administration
15732837|NCT05002244|Drug|CTL0801 (Azilsartan) + CTL0802 (Rosuvastatin)|CTL0801 (Azilsartan) + CTL0802 (Rosuvastatin), single dose, daily, repeated oral administration
15732838|NCT05002231|Drug|Losmapimod 15 mg oral tablet|Subjects will receive one losmapimod 15 mg tablet by mouth under fasted conditions.
15732839|NCT05002231|Drug|Losmapimod two 7.5 mg oral tablets|Subjects will receive two losmapimod 7.5 mg tablets by mouth under fasted conditions.
15732840|NCT05002231|Drug|Losmapimod one 15 mg oral tablet|Subjects will receive one losmapimod 15 mg tablet by mouth under fed conditions.
15732841|NCT05002218|Behavioral|Aerobic Training|Aerobic training on stationary bike 5x a week for 30 minutes a day.
15732842|NCT05002218|Behavioral|Balance Training|Balance training 5x a week for 30 minutes as instructed by a therapist. Standard of care.
15732843|NCT05002205|Other|Questionnaires|Participants will be followed up by means of online surveys and 2 study visits.
15732844|NCT05002205|Other|spirometry|During two study visits, the lung function will be measured (FVC, FEV1)
15732845|NCT05002205|Other|ECG|During two study visits, the presence of arrhythmia will be explored.
15732846|NCT05002205|Other|1 minute sit to stand test|Physical endurance is tested during 2 study visits.
15732847|NCT05002205|Other|Vital parameters|blood pressure, pulse, weight
15732848|NCT05002192|Drug|Eucalyptol, Limonene and Pinene Enteric Soft Capsule|Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP_ONLY and EXP_ONLY cohort
15732849|NCT05002192|Drug|Ambroxol injection|Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP+AMB and cohort EXP+AMB Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP+AMB and AMB_ONLY cohort Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP+AMB and AMB_ONLY cohort
15732850|NCT05002192|Drug|Other oral mucolytic drugs|Compare the efficacy, safety and economic evaluation of pneumonia expectorant treatment in the cohort of ELP_ONLY and EXP_ONLY cohort
15732892|NCT05001828|Drug|ADI-PEG 20|ADI-PEG 20 in combination with venetoclax and azacitidine
15732851|NCT05002179|Drug|Echinaforce Chewable tablets|"Preventive treatment: 3X2 EC tablets daily during 2 + 2 months of prevention after run-in of 1 week and intermittent treatment break of 1 week without treatment + 1 month of voluntary follow-up prevention.
~Acute treatment: 5 X 2 EC tablets daily for max. 10 days per individual vRTI or until symptom resolution."
15732852|NCT05002166|Other|labortatory such as fecal calprotectin ,CRP,CBC,ESR. Endoscopic examination of the gastrointestinal tract Histological examination of the biopsies retrieved during gastrointestinal endoscope.|labortatory such as fecal calprotectin ,CRP,CBC,ESR. Endoscopic examination of the gastrointestinal tract Histological examination of the biopsies retrieved during gastrointestinal endoscope.
15732853|NCT05002153|Other|Fecal microbiota transplantation (FMT)|FMT is the process of transferring stool from a healthy donor to another.
15732854|NCT05002153|Other|Placebo|Placebo capsules consist a combination of agarose in normal saline/glycerol (the same vehicle as in a FMT capsules)
15732855|NCT05002140|Drug|XRD-0394|Single ascending dose
15732856|NCT05002140|Radiation|Palliative radiotherapy|4 Gy × 5 daily fractions
15732857|NCT05002127|Drug|Evorpacept (ALX148)|IV Q2W
15732858|NCT05002127|Drug|Trastuzumab|IV Q2W
15732859|NCT05002127|Drug|Ramucirumab|IV Q2W
15732860|NCT05002127|Drug|Paclitaxel|IV Days 1, 8, and 15 of a 28-day cycle
15732861|NCT05002114|Drug|Cannabidiol|Topical CBD cream - special formulation
15732862|NCT05002114|Other|Placebo|Not the drug
15732863|NCT05002101|Dietary Supplement|zinc|The zinc syrup was prepared with a concentration of 7 mg zinc in each 5 ml solution. Accordingly, children with weight more than 10 kg were asked to take 5 ml syrup daily, while children with weight less than 10 kg were asked to take 2.5 ml daily.
15732864|NCT05002101|Drug|Placebo|Children with weight more than 10 kg were asked to take 5 ml syrup daily, while children with weight less than 10 kg were asked to take 2.5 ml daily.
15732866|NCT05002075|Other|m-health cardiac rehabilitation|Participants randomized to m-Health cardiac rehabilitation will receive a 24-week home-based exercise program delivered via a previously validated, commercially available smartphone platform called Movn (Moving Analytics, California). This app includes a patient-facing iOS and Android compatible smartphone app and an integrated hospital-facing online dashboard for remote monitoring and care coordination by a trained coach
15732867|NCT05002062|Device|"RehaCom computer-based cognitive training in addition to Conventional physical therapy program"|"Rehacom procedure: It is a computer-based intensive cognitive rehabilitation test used to assess patient's cognitive functions. It includes 32 assessment tasks for attention, memory , logical reasoning& executive functioning. It composes of regular PC , 1G RAM , DVD drive, 100 GB hard drive with windows XP SP3, 128 MB RAM direct 3D graphic card , Screen at least 19 , regular PC keyboard or Rehacom panel & printer .The Rehacom software version is (patient enpult (1990-1997) EN/ISO-13485-certified). It is characterized by easy handling, close to reality , motivating for patients."
15732868|NCT05002062|Other|Conventional physical therapy program|Conventional physical therapy program for MS patients include aerobic training, resistive training and flexibility program
15732869|NCT05002049|Behavioral|Intervention Group|Teenagers with leadership skills from intervention schools (called ambassadors) and stakeholders will participate in focus groups to gain insights on the barriers and facilitators for healthy lifestyles of teenagers, and how science could help address these. Building on the information of the focus groups, ambassadors, stakeholders and other peers will participate in a collaborative competition event where the SEEDS intervention(s) will be designed. The intervention(s) will be implemented at intervention high-schools during 6 months. Outcomes in health behaviours and science literacy will be assessed by validated questionnaires at the start and end of the project.
15732870|NCT05002036|Device|Trium eyedrops|given three times daily from day 1 after surgery to end of Week 4
15732871|NCT05002010|Device|Echo|Measure the Left ventricle (LV): IVS (interventricular septum), LVEDD(left ventricle end diastolic dimension ),LVESD((left ventricle end systolic dimension ), PWD(posterior wall dimension), LV systolic dysfunction and LV diastolic dysfunction.
15732872|NCT05001997|Dietary Supplement|Lactose free probiotic yogurt|Probiotics are non-pathogenic, live microbes that when eaten or administered In adequate amount, it confer health benefits to host. Only lactose free probiotic yogurt containing cultures such as Lactobacillus acidophilus and Bifidobacterium lactis will be selected.
15732873|NCT05001984|Drug|Alirocumab|Alirocumab 75mg subcutaneously every 2 weeks for a total of 26 weeks.
15732874|NCT05001971|Drug|Anlotinib Plus Penpulimab|Anlotinib: 10mg orally daily on day 1 to 14 of a 21-day cycle. Penpulimab: 200mg by intravenous drip on day 1 of a 21-day cycle.
15732875|NCT05001958|Behavioral|Action observation|Participants will view a video of a task performed by a non-disabled actor and then the participants perform the task from the video with their weaker arm & hand.
15732876|NCT05001945|Drug|MLS-101|MLS-101 tablet(s) by mouth once or twice daily.
15732877|NCT05001945|Other|Placebo|Placebo tablet(s) by mouth once or twice daily.
15732878|NCT05001932|Procedure|Cataract surgery|Randomized Clinical Trial
15732879|NCT05001919|Procedure|GTR|intrabony defects treated by surgery and bone graft +collagen membrane
15732880|NCT05001919|Procedure|concentrated growth factor|intrabony defects treated by surgery and bone graft +concenrated growth factor membrane
15732881|NCT05001906|Behavioral|Exercise group|The exercise program comprises static and dynamic breathing exercises, muscle stretching exercises and muscle strength exercises, exercises to strengthen the abdominal wall muscles, exercises to strengthen the thigh muscles - quadriceps femoris (lat. musculus quadriceps femoris), to strengthen gluteal muscles, exercises to increase pelvic mobility, exercise to improve circulation, as well as pelvic floor muscle training with relaxation techniques.
15732882|NCT05001893|Device|S53P4 bioactive glass putty|Bonalive putty/putty MIS paste is a synthetic, bioactive, osteoconductive, osteostimulative bone void filler for filling, reconstruction, and regeneration of bone defects.
15732893|NCT05001815|Device|Continuous subcutaneous insulin infusion (CSII)|The CSII device used in this study has access to mobile phone, however, without CGM enhanced function
15732894|NCT05001815|Device|Multiple daily insulin injection (MDI)|Patients with indication will receive MDI treatment with at least one basal insulin injection plus 2 to 3 prandial insulin injection.
15732895|NCT05001802|Procedure|transverse scan, in-plane, posterior- anterior quadratus lumborum block|transverse scan, in-plane, posterior- anterior quadratus lumborum block The patients will receive the transmuscular quadratus lumborum block before surgery using the transverse scan, in-plain, posterior to anterior approach. 0.6ml/kg 0.375% ropivacaine is injected when the correct needle location is confirmed.
15732896|NCT05001802|Procedure|paramedian sagittal longitudinal scan, in-plane, caudal-cranial quadratus lumborum block|The patients will receive the transmuscular quadratus lumborum block before surgery using the paramedic sagittal longitudinal scan, in-plain, caudal-cephalic approach.0.6ml/kg 0.375% ropivacaine is injected when the correct needle location is confirmed.
15732897|NCT05001789|Other|CogMed|20 sessions of Cogmed working memory training
15732898|NCT05001776|Procedure|Endovenous laser ablation|Laser ablation of the great saphenous vein close to sapheno-femoral junction
15732899|NCT05001776|Drug|Fondaparinux Sodium|Fondaparinux sodium for 7 days or 45 days
15732900|NCT05001763|Drug|Prucalopride|Prucalopride, 2mg, tablet. First given 2 days before surgery beginning on POD 1, until defecation or for a maximum of 7 days of postoperative treatment
15732901|NCT05001763|Drug|Placebo|Glucose, 2mg, tablet.
15732902|NCT05001750|Drug|long term prophylactic antibiotics|VRIs in patients who also receive a pre-procedural dose of antibiotics with continued dosing of antibiotics for the duration of the external ventricular drain IRB NUMBER: 2021-12680 IRB APPROVAL DATE: 06/14/2021 NOABX in EVD Study 3 (EVD).
15732903|NCT05001737|Drug|Emapalumab|Emapalumab iv infusion
15732904|NCT05001724|Biological|KN046|KN046 is 5 milligram per kilogram, every 2 weeks.
15732905|NCT05001724|Drug|Lenvatinib|Lenvatinib is RP3D milligram per day, every day.
15732906|NCT05001724|Drug|Docetaxel|Docetaxel is 75 milligram per Square meter, every 3 weeks.
15732907|NCT05001711|Device|Aria CV Acute PH System|The Aria CV Acute PH System is indicated for evaluation of hemodynamic responses (e.g. pulmonary arterial compliance, cardiac output, and effective arterial elastance) to an intravascular Balloon catheter temporarily placed in the pulmonary artery in symptomatic adult patients with WHO Group 2 or WHO Group 3 pulmonary hypertension and right ventricular dysfunction.
15732908|NCT05001698|Biological|Anifrolumab|intravenous infusion (IV)
15732909|NCT05001672|Drug|Tenofovir alafenamide|Tenofovir alafenamide (TAF, brand name: Vemlidy) is a hepatitis B virus nucleotide reverse transcriptase inhibitor oral medication for the treatment of chronic hepatitis B virus infection. It is a prodrug of tenofovir. Closely related to the commonly used reverse-transcriptase inhibitor tenofovir disoproxil fumarate, TAF has greater antiviral activity and better distribution into lymphoid tissues than that agent. Vemlidy was approved by the U.S. Food and Drug Administration (FDA) in November 2016 and the TAIWAN Food and Drug Administration (TFDA) in April 2017.
15732910|NCT05001659|Other|computer simulator and mannequin simulator|compared two different training simulators with respect to training effectiveness in ACLS training.
15732911|NCT05001646|Device|In-home resonance-based electromagnetic field protection device|Participants will have an in-home EMF protection device
15732912|NCT05001633|Behavioral|modified media content paradigm|media content
15732913|NCT05001633|Behavioral|control|media content experience
15732914|NCT05001620|Other|Palliative Care Consultation|"The PC provider conducts the structured PCC-PAC via videoconference or telephone with the PLWD and/or their care partner and the social work (SW) champion in the NH. The SW and PC provider will set up a mutually agreed upon consultation day/time with the PLWD and/or care partner, within 5 business days of NH admission and follow up visits will occur no more than 30 days later (if needed).
~Note: a PLWD who receives the intervention will not be in the stakeholder engagement plan."
15732915|NCT05001607|Device|Bronchial Blocker|Trial of four methods of pulmonary blockade; one novel method and three published methods.
15732916|NCT05001594|Device|Active vibratory knee device|The active, wearable device is placed above and below the knee joint. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide vibratory feedback to the subject.
15732917|NCT05001581|Procedure|Arthroscopic partial repair of massive rotator cuff tear|Surgery relies on arthroscopic reconstruction of the rotator cuff tendons. Because of irreparability of Supraspinatus tendon ( always) and infraspinatus tendon ( sometimes) surgeon performed partial repair to cover humeral head by the tendons
15732918|NCT05001581|Procedure|Arthroscopic partial repair of rotator cuff with biceps augmentation|Surgery relies on arthroscopic reconstruction of the rotator cuff tendons. Because of irreparability of Supraspinatus tendon ( always) and infraspinatus tendon ( sometimes) surgeon performed partial repair to cover humeral head by the tendons and because of good quality of the long head of the biceps tendon, its uses as biological reinforcement of the reconstruction to achieve better clinical and radiological outcome
15732919|NCT05001568|Device|Immediate in-brace correction: Conventional Brace|The trunk surface will be scanned to reconstruct a numerical model of the patient's trunk, this reconstruction will help to produce the optimized brace. The patient skeletal will also be reconstructed from a bilateral radiograph using an EOS imaging system. Each patient will try both the control and the test brace. Radiographic (supine position) and patient-reported data will be gathered and analyzed to observe changes between the immediate correction of the braces. The SRS-22r will be collected. The study protocol requires no additional visits beyond the standard of care. There will be one additional radiograph compared to the standard of care.
15732920|NCT05001568|Device|Immediate in-brace correction: Optimized Brace|The trunk surface will be scanned to reconstruct a numerical model of the patient's trunk, this reconstruction will help to produce the optimized brace. The patient skeletal will also be reconstructed from a bilateral radiograph using an EOS imaging system. Each patient will try both the control and the test brace. Radiographic (supine position) and patient-reported data will be gathered and analyzed to observe changes between the immediate correction of the braces. The SRS-22r will be collected. The study protocol requires no additional visits beyond the standard of care. There will be one additional radiograph compared to the standard of care.
15732984|NCT05000970|Other|Telehealth Consult|Telehealth consult with an RN
15732921|NCT05001568|Device|Long-term bracing: Conventional Brace|After comparing the immediate correction of the braces, each patient will be using either the test or the control brace for a period of two years. There will be follow-up visits, between 6 months and 1 year depending on the patient growth. The brace will be renewed using the same procedure to adapt to the patient's growth. The study protocol requires no additional visits beyond the standard of care. There will be no additional radiograph compared to the standard of care. Compliance monitors are installed in each brace.
15732922|NCT05001568|Device|Long-term bracing: Optimized Brace|After comparing the immediate correction of the braces, each patient will be using either the test or the control brace for a period of two years. There will be follow-up visits, between 6 months and 1 year depending on the patient growth. The brace will be renewed using the same procedure to adapt to the patient's growth. The study protocol requires no additional visits beyond the standard of care. There will be no additional radiograph compared to the standard of care. Compliance monitors are installed in each brace.
15732923|NCT05001555|Drug|Dexketoprofen/Vitamin B|1 capsule containing 25 mg of dexketoprofen / vitamin B (thiamine mononitrate 100 mg, Pyridoxine hydrochloride 50 mg, Cyanocobalamin 0.50 mg), orally, every 8 hours, for 7 days.
15732924|NCT05001555|Drug|Dexketoprofen|1 tablet of dexketoprofen 25 mg, orally, every 8 hours, for 7 days.
15732925|NCT05001542|Other|Educational moral injury video|Educational video that addresses the identification of moral injury and distress in frontline healthcare workers during COVID-19; offers available interventions at the levels of individual, team and organization
15732926|NCT05001529|Biological|anti IL5 receptor antibodies|Subjects with severe uncontrolled asthma will be assigned to treatment with Omalizumab (anti Ig E antibodies) or Mepolizumab (anti IL-5 antibodies) according to medical advice and standardized protocols for asthma treatment.
15732928|NCT05001503|Device|Stability UO|STABILITY UO is a standalone software, based on a Bayesian model, which quantifies the risk of an individual patient developing severe oliguria (0.3mg/kg/hr for 6 hours). The model identifies at risk patients by predicting future urine output, using only previously recorded urine output values for that individual, allowing clinicians to see the predicted risk of a patient developing severe oliguria in real time.
15732929|NCT05001490|Other|Smartphone application based reminder|Brushing reminders were given to the patients in experimental group through a smartphone application twice daily
15732930|NCT05001477|Device|TULSA Procedure|Transurethral ultrasound ablation procedure
15732931|NCT05001464|Device|reflectance pulse oximeter|Wearing reflectance pulse oximeter at the same time on the night of PSG examination
15732933|NCT05001438|Procedure|Hidro|Guided by ultrasonography under anesthetic blockage of the circumflex nerve and the supraescapular nerve. The hidrodilatation is achieved by insuflating the articulation with 2 cc of trigon depot + 10 cc 1% mepivacain + 11 cc saline serum.
15732934|NCT05001438|Procedure|MUA|Movilization under anesthesia
15732935|NCT05001412|Drug|Camrelizumab; apatinib; carboplatin; etoposide|2 cycle chemotherapy (carboplatin and etoposide), and then 2 cycle chemotherapy (carboplatin and etoposide) combine with Camrelizumab and apatinib, finally maintenance therapy with Camrelizumab and apatinib
15732936|NCT05001399|Behavioral|Holographic Memory Resolution® (HMR)|Clients will participate in Holographic Memory Resolution® (HMR) administered by a trained HMR practitioner. Clients will be introduced to relaxation techniques and safe scene identification. This exercise encourages the client to identify a place in which they feel safe and where nobody can be there without client's invitation. Clients will then describe the place and associated colors of the experience, how the colors move in their body, and how they move through their safe scene. The subsequent 2-3 sessions will continue to explore safe scene and color therapy.
15732937|NCT05001386|Biological|Blood collection for the evaluation of the anti-drugs sensitivity|The M.D investigators and the medical team identify the patients ( index cases and healthy volunteers) in a medical appointment. They inform them, collect the non-opposition right and the blood samples: 5 mL heparin tube and 5 mL dry tube for each person , one time.
15732938|NCT05001373|Biological|Core-g28v2 60mer mRNA Vaccine|100µg, Intramuscularly
15732939|NCT05001373|Biological|eOD-GT8 60mer mRNA Vaccine|100µg, Intramuscularly
15732941|NCT05001347|Drug|TJ004309|Antibody to CD73
15732942|NCT05001334|Behavioral|Kangaroo care training|During perinatal period, mothers are given extra training (other than routine newborn care) about kangaroo care. Baby-mother diad is called for weight check-ups.
15732943|NCT05001321|Radiation|The whole abdomen contrast-enhanced CT scan|All the participants were measured by the whole abdomen contrast-enhanced CT scan.
15732944|NCT05001321|Other|H&E stained sections and slides|HE pathological examination was performed on all specimens of enrolled patients.
15732945|NCT05001295|Procedure|Physical Activity|Following the guidelines of NICE, the program to be followed by the IG is designed so that the intervention lasts 5 weeks, divided into 4 levels of progressive intensity, in which sessions of 30 to 45 minutes of aerobic exercise will be carried out 2 days a week. week.
15732946|NCT05001282|Drug|ELU001|Folic-acid functionalized C'Dot-Drug-Conjugate (FA-CDC)
15732947|NCT05001269|Drug|nedosiran|Monthly subcutaneous dosing throughout study period
15732949|NCT05001243|Drug|Compound Pilocarpine, Brimonidine, Oxymetazoline, Hyaluronic acid, Bromfenac|PBOHB to improve uncorrected near vision in healthy presbyopic patients
15732950|NCT05001243|Drug|Pilocarpine Hydrochloride|Apply in the fellow eye
15732951|NCT05001243|Drug|Brimonidine Tartrate|Apply in the fellow eye
15733598|NCT04996186|Other|Clinical interviews|Semi-qualitative interviews and questionnaire STAR-Q
15732952|NCT05001217|Drug|Conventional medication|Levodopa, dopamine agonist, Monoamine oxidase-B inhibitors, Catechol-O-methyltransferase inhibitors, etc.
15732953|NCT05001217|Drug|Chinese herbal medicine treatment|"Huanglian Wendan Decoction
~Jin Gui Shen Qi Pill
~Qi Ju Dihuang Pill plus Zhen Gan Xi Feng Decoction
~Bu Yang Huan Wu Decoction Combined Chang Yuan Wendan Decoction"
15732954|NCT05001204|Drug|68Ga-NOTA-RM26|68Ga-NOTA-RM26 were injected into the patients before the PET/CT scans
15732955|NCT05001191|Other|Gentle Human Touch|Gentle human touch, which has a pain and stress-reducing effect, is a sensitive tactile stimulus applied to the skin, without caress or massage, which provides a kind of relaxation.
15732956|NCT05001165|Other|Proactive Panel Management Clinics for HFrEF|Novel clinic based on review of panel HFrEF data and impromptu telephone or video patient contacts/visits.
15732957|NCT05001152|Drug|Ozanimod|Taste assessment
15732959|NCT05001126|Behavioral|HIFT 1x/week|HIFT is a time-efficient modality of exercise combining high-intensity aerobic and resistance training using minimal equipment. HIFT 1x/week represents a dose of one HIFT workout per week.
15732960|NCT05001126|Behavioral|HIFT 2x/week|HIFT is a time-efficient modality of exercise combining high-intensity aerobic and resistance training using minimal equipment. HIFT 2x/week represents a dose of two HIFT workouts per week.
15732961|NCT05001126|Behavioral|HIFT 3x/week|HIFT is a time-efficient modality of exercise combining high-intensity aerobic and resistance training using minimal equipment. HIFT 3x/week represents a dose of three HIFT workouts per week.
15732962|NCT05001113|Procedure|the subxiphoid approach thoracoscopic thymectomy|A 2-cm straight incision was made in the middle of the xiphoid process, the incision was used as a thoracoscope hole, and the xiphoid process could be removed if necessary. The surgeon used the oval forceps to release the left and right soft tissue gaps behind the sternum, from the anterior mediastinum tunnel. Two 0.5 cm extrapleural thoracic ports under the bilateral costal arches were created, and this incision was used as an operation hole. The thread puncture cone with a diameter of 0.5 cm was placed under the guidance of the finger.
15732963|NCT05001113|Procedure|the lateral intercostal approach thoracoscopic thymectomy|"Right-side approach: Use the left supine position. The observing port was created at the right axillary midline line in the fourth intercostal space, and the other two ports were made as to the operation hole along the anterior axillary lines in the third and fifth intercostal spaces.
~Left-side approach: Use the right supine position. The observing port was created at the left axillary midline line in the fourth intercostal space, and the other two ports were made as to the operation hole along the anterior axillary lines in the third and fifth intercostal spaces."
15732964|NCT05001100|Other|rehabilitation|rehabilitation
15732965|NCT05001087|Other|Observation|Not applicable-Observational study
15732966|NCT05001074|Drug|Extended release tacrolimus|de novo cohort: participants are randomised for extended release tacrolimus or immediate release tacrolimus direct post-lung transplantation Conversion cohort: participants are randomised for extended release tacrolimus or immediate release tacrolimus when >1 year post-lungtransplantation and with stable graft function
15732967|NCT05001074|Drug|Immediate release tacrolimus|de novo cohort: participants are randomised for extended release tacrolimus or immediate release tacrolimus direct post-lung transplantation Conversion cohort: participants are randomised for extended release tacrolimus or immediate release tacrolimus when >1 year post-lungtransplantation and with stable graft function
15732968|NCT05001061|Drug|Misoprostol Pill|sublingual versus vaginal Misoprostol in termination of first trimester missed abortion
15732969|NCT05001048|Drug|Phenylephrine Hydrochloride|Series of three incremental bolus injections to observe α1-adrenoreceptor mediated vasoconstriction.
15732970|NCT05001048|Other|Cold Pressor Test|Standardized sympathetic stressor involving submersion of the hand in ice-cold water for 3-minutes, aiming to elicit endogenous neurotransmitter release and blood pressure increases.
15732971|NCT05001048|Other|Isocapnic Acute Hypoxia|During low altitude assessment, participants will be exposed to isocapnic hypoxia equivalent to 3,800m to assess responses to acute exposure.
15732972|NCT05001048|Other|Hyperoxia|During high altitude assessments, participants will breathe an oxygen concentration comparable to their end-tidal values at low altitude for the assessment of the influences of acclimatization.
15732973|NCT05001035|Other|Time of assessment|Immediate and after one month and after two months
15732974|NCT05001022|Drug|ALG-020572|Single or multiple doses of ALG-020572
15732975|NCT05001022|Drug|Placebo|Single or multiple doses of Placebo
15732976|NCT05001009|Behavioral|Clinician Implementation Strategy Stage 1|"A booster of the established LSTDI implementation strategy. Clinicians will be presented with summary written/electronic materials on the LSTDI developed for the study. Online training options and when and how to complete goals of care conversations and documentation will be highlighted."
15732977|NCT05001009|Behavioral|Clinician Implementation Strategy Stage 2|"This includes two components:
~Team facilitation to help the primary care team (advance practice provider, nurse, social worker) work together to create roles and responsibilities for accomplishing goals of care conversations with patients
~A patient list trigger of patients potentially eligible for goals of care conversations (the patient study population) will be sent to the primary care clinicians."
15732978|NCT05001009|Behavioral|Low patient engagement|Patients will be sent information about goals of care conversations, including the PREPARE website.
15732979|NCT05001009|Behavioral|High patient engagement|Patients will be sent information about goals of care conversations, including the PREPARE website. Follow-up phone calls to discuss goals of care conversations and the PREPARE website will be made.
15732980|NCT05000996|Procedure|Bariatric Surgery|Roux-en-Y gastric bypass (RYGB) and vertical sleeve gastrectomy (VSG)
15732981|NCT05000983|Drug|PluroGel|A 0.5 cm layer of PluroGel® followed by the above standard dressing. In addition, this will be covered with moistened gauze, kept moist twice daily. (The additional factors are the use of PluroGel® and moistened gauze. Standard dressing will continue to be used.)
15732982|NCT05000983|Drug|Standard dressing|Topical antibiotic ointment (Polysporin™ or formulary equivalent) and non-adherent petrolatum fine-meshed gauze (ADAPTIC™) applied every Monday, Wednesday and Friday (or equivalent).
15732983|NCT05000970|Device|blood pressure cuff PLUS tablet|all arms
15733003|NCT05000944|Other|breakfast omission (BO)|this group will not be provided with a breakfast until lunch time (at 12:30).
15733004|NCT05000944|Other|early-morning breakfast consumption (EM-BC)|this group will be provided with an early morning breakfast (at 08:30).
15733005|NCT05000944|Other|mid-morning breakfast consumption (MM-BC)|this group will be provided with a mid (late) morning breakfast (at 10:30).
15733006|NCT05000931|Device|Osia 2 System|Osia 2 System in a pediatric population aged 5 - 11 years by quantifying the type, frequency and severity of adverse events.
15733007|NCT05000918|Dietary Supplement|Okara protein hydrolysate (OPH)|Okara protein hydrolysate (OPH) was a pack of dried beige powder. It can be stored at room temperature, but it must be exposed to direct sunlight.
15733008|NCT05000905|Behavioral|Adaptive Attention Training|The training is comprised of a time-based titration of rich audiovisual and sparse audio interactive environments. Training progressively transitions the participants from an immersive and rapid reward setting to a less immersive, sensory impoverished, and slower reward setting. Further, the participants' actions require delayed gratification decisions to accomplish play in the sparse setting, building fronto-parietal control through sustained attention and suppression of ventral-striatal reward impulses.
15733009|NCT05000892|Drug|Sintilimab , Carboplatin, Nab-paclitaxel|Patients receive Sintilimab IV on day 1, paclitaxel IV on day 1 and carboplatin IV on day 1 . Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity.
15733010|NCT05000879|Behavioral|MMB for Moms|12-week program that emphasizes mindfulness and cognitive behavioral skills
15733011|NCT05000866|Behavioral|Communication skills training video|The communication skills training video component is designed to be self-delivered. Four couples are depicted in separate scenes discussing HIV testing, drug use, sexual agreements, and drug use during sex. Each scene is viewed twice. In the initial viewing, the couple in the video makes one or more communication errors. The scene is subsequently viewed a second time and the couple utilizes more effective communication skills, resulting in a more adaptive resolution. Each scene is introduced by a narrator who points out communication errors and orients viewers to skills utilized in adaptive versions of each scene.
15733012|NCT05000866|Behavioral|Drug use module|The substance use module is administered after step 5 of CHTC and prior to the delivery of rapid HIV-test results. The couple was first asked to fill in a calendar for the past 30 days, indicating each day on which either member used drugs or consumed alcohol. Completion of the calendar is done through an ACCESS database to facilitate remote intervention delivery. After completion of the calendar, the HIV tester asked a series of debriefing questions designed to elicit the couples' perspective on their use, establish the couple's goals and limits for drug use, and make plans to achieve these goals.
15733013|NCT05000853|Drug|Iron Carboxymaltose|Iron supplementation when is needed according to usual care
15733015|NCT05000827|Device|PSMA-PET/CT|In the intervention arm patients will only undergo ePLND in addition to robot-assisted radical prostatectomy (RARP) in case of suspected LNI on PSMA PET/CT (miN1), whereas ePLND will be omitted in those without PSMA positive lymph nodes (miN0).
15733016|NCT05000827|Other|Nomogram|Current standard of care includes performing extended pelvic lymph node dissection (ePLND) in all patients with primary prostate cancer and a nomogram-based risk of LNI >5%
15733017|NCT05000814|Device|DLT|VDLT versus the use of DLT with fiberoptic bronchoscope
15733018|NCT05000801|Biological|DC vaccine|Autologous/or HLA-matched donors' DCs loaded with WT1/TERT/survivin
15733019|NCT05000788|Behavioral|Qigong|Eight-Section Brocades Practice: The treatment group will undergo an 8-week Eight-Section Brocades intervention program consists of a total of 16 group training sessions with two 1-hour sessions per week. The treatment group participants will be provided with health qigong exercise in a group format led by qualified qigong instructors. All the health qigong instructors will be trained by a certified Traditional Chinese Medicine (TCM) practitioner with an expertise in health qigong and they are required to pass the certification examination before delivering health qigong intervention at the clinical settings. The Eight-Section Brocades protocol will be used in this study because it is easy to learn by the participants and the clinical effects on psychosocial health were evidenced in previous RCTs. A complete cycle of the Eight-Section Brocades took 12 minutes for completion, which consists of eight sequential and simple forms of movements.
15733020|NCT05000788|Behavioral|Exercise|Exercise Program: Participants in the control group will attend a physical exercise program for 8 weeks (1-hour sessions, 2 times a week). The exercise program will incorporate aerobic fitness, strength training, body weight workouts, balance training, flexibility and stretching into the training plan. The exercise program is provided in a group format, which will be led by qualified physical trainer.
15733021|NCT05000775|Dietary Supplement|G-Niib|G-NiiB®, a patent-protected microbiome immunity formula, composed of naturally occurring food-grade bacteria approved by health authorities, has been developed by a group of CUHK gastroenterology experts.
15733022|NCT05000775|Dietary Supplement|Placebo|Placebo
15733023|NCT05000762|Dietary Supplement|Zinc|Zinc gluconate 30 mg/day orally
15733024|NCT05000749|Behavioral|DBT-SG|Dialectical Behavior Therapy Skills Group (DBT-SG) in addition to VHA treatment as usual. Group is 24 weekly sessions teaching skills in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness.
15733025|NCT05000749|Behavioral|VHA treatment as usual|VHA treatment as usual for Veterans at risk for suicide attempt
15733026|NCT05000736|Drug|palbociclib + aromatase inhibitor|palbociclib + aromatase inhibitor therapy
15733027|NCT05000736|Drug|fulvestrant|fulvestrant monotherapy
15733028|NCT05000723|Other|Standard of care|"Standard of care consisting of
~clearance of infection
~treatment with antibiotics (antisuppressive, DAIR) or surgery (1 stage, 2 stage Girdlestone)
~Radiology: X-ray pelvis and hip, X-ray pelvis with kingmark, CT scan pelvis/hip"
15733029|NCT05000710|Drug|Durvalumab|Durvalumab administered IV over 60 minutes at a dose of 1500 mg every 4 weeks
15733030|NCT05000710|Drug|Tremelimumab|Tremelimumab administered IV over 60 minutes at a dose of 300 mg , twice: at C1D1 and C4D1
15733031|NCT05000710|Radiation|Low dose irradiation|21 days after the first immunotherapy treatment 11 fractions of 3 Gy will be administrated to metastatic or primary lesion/s over 2 weeks and one day
15733032|NCT05000697|Drug|Oxaliplatin|Patients will receive 5FU + Oxaliplatin during the consolidation chemotherapy after long course chemoradiation
15733033|NCT05000697|Drug|5FU|Patients will receive 5FU during the consolidation chemotherapy after long course chemoradiation
15733034|NCT05000684|Drug|JS004 in combination with toripalimab|Usage and dosage: Inject 200mg once every 3 weeks
15733035|NCT05000671|Drug|STC314 injection or Placebo(rate=58.3 mg/hr)|To receive continuous infusion of STC314/Placebo injection at rate 58.3mg/hr up to 3 days (72hours). Also to receive appropriate standard of care.
15733036|NCT05000671|Drug|STC314 injection or Placebo(rate=87.5 mg/hr)|To receive continuous infusion of STC314/Placebo injection at rate 87.5mg/hr up to 3 days (72hours). Also to receive appropriate standard of care.
15733037|NCT05000658|Drug|Dexamethasone phosphate|HSC injection of 4mL
15733038|NCT05000645|Behavioral|Grocery delivery|Each food delivery will contain approximately $35 worth of fresh fruits, vegetables, dairy products, and whole grain foods. These foods are not meant to supplant regular meals, rather make healthy eating more convenient.
15733039|NCT05000645|Behavioral|Unsweetened beverage delivery|Participants will receive unsweetened beverages to replace normal sugar-sweetened beverage intake.
15733040|NCT05000632|Behavioral|Smoke Free SafeCare|SFSC is the systematically braided curriculum which combines both SafeCare and STBO programs, but in a new delivery format. To take full advantage of the home delivery mechanism of SafeCare, the content delivery of STBO has been adapted so that original mailings will be delivered in the SafeCare sessions. STBO has been fully braided into the Health and Safety modules. One of these interventions will be delivered first throughout the course of the study. The Smoke Free SafeCare intervention will involve 25 providers receiving training for the SFSC program. They will each recruit 10 mothers and conduct the SFSC program for each family. Overall, 250 families will receive the SFSC intervention.
15733075|NCT05000398|Other|Short foot|While standing , the medial arch will be raised by trying to bring the metatarsal heads closer to the heel . The patient will be asked to move the big toe closer to the heel without bending the toes and without lifting the heel off the ground.2 sets will be performed as 10 repetitions. 30 seconds of rest will be given to prevent fatigue between sets.
15733041|NCT05000632|Behavioral|Standard SafeCare|SafeCare is a brief parenting intervention that is highly effective in reducing child maltreatment perpetration and improving behavioral outcomes for CPS-involved parents of young children (0 to 5 years) as the result of child physical abuse or neglect (the two most common forms of substantiated maltreatment). The Standard SafeCare intervention will involve 25 SafeCare providers delivering the SafeCare program as usual. They will each recruit 10 mothers and conduct SafeCare for each family. Overall, 250 families will receive the standard SafeCare.
15733042|NCT05000619|Behavioral|Outreach mailer|Postcard or letter
15733043|NCT05000619|Behavioral|Humor/Salience|Funny cartoon
15733044|NCT05000619|Behavioral|Doctor's authority|Letter from a doctor
15733045|NCT05000619|Behavioral|Information|Information about benefits of the appointment
15733046|NCT05000606|Other|A home visit program|A home visit program including education and counseling was applied. A total of five home visits over three months were performed.
15733047|NCT05000593|Other|normal saline|Intra-articular injection of normal saline
15733048|NCT05000593|Other|Cord Blood Mononuclear Cells (UCB-MNCs)|Intra-articular injection of Cord Blood Mononuclear Cells (UCB-MNCs)
15733049|NCT05000580|Procedure|Surgical|Conservative vs surgical management
15733050|NCT05000567|Other|12 week nordic hamstring exercise program|12 weeks progressive eccentric strength training program targetting the hamstring muscles.
15733051|NCT05000554|Procedure|Neoadjuvant Therapy|"Drug:
~Camrelizumab 200mg,d1，Repeat every 21 days for 3 courses； Oxaliplatin 130mg/m² ,d1;S-1 40-60mg,Bid, d1-14; S-1: bsa<1.25m2,40mg/time，twice a day；bsa1.25~1.5m2，50mg/time，twice a day；bsa≥1.5m2,60mg/次，twice a day，d1-d14；
~Procedure: Gastric cancer resection Distal gastrectomy combined with D2 lymph node dissection"
15733052|NCT05000528|Other|therapeutic education|In groups of 5-6, patients will have a one-day therapeutic training session comprising 4 workshops: how to create a sleep agenda; normal sleep; sleep hygiene; medical treatments.
15733053|NCT05000528|Other|Actimetry|once from inclusion for 2 weeks, second for 2 weeks starting 2 weeks after intervention
15733057|NCT05000489|Other|No intervention being administered|No intervention will be administered. Each patient will participate in a qualitative focus group discussing their beliefs/attitudes about their reproductive health and birth control
15733058|NCT05000476|Other|eye mask and earplugs|Materials similar to those offered on long commercial flights
15733059|NCT05000476|Other|Nurse Education and Environmental Regulation|providing orientation to the patient (frequent orientation of the patient to the place, time and person), cognitive stimulation (objects such as clocks and calendars in the patient's field of view), reducing noise and light (minimizing monitors and fluid infusion pump alarms at night), providing early mobilization ( passive-active joint movements, sitting and walking in bed), reducing social deprivation (receiving visitors, telephone calls)
15733060|NCT05000463|Drug|Ozone|The participants will lay flat and the area of injection will be prepared with antiseptic. Maintenance of ultrasonography probe sterility was also guaranteed using a sterile barrier. Under sonographic guidance, superficial peroneal nerve, deep peroneal, sural , asphenous, and tibila nerves will be injected An ozone/oxygen mixture ( 25μg/ml) will be injected in each nerev
15733061|NCT05000463|Drug|Convtrol group|The medical treatment included optimal glycemic control, vitamin B complex, a lipoic acid, selective serotonin reuptake inhibitors, and pregabalin.
15733062|NCT05000450|Genetic|ALLO-605|ALLO-605 is an anti-BCMA, TRAC/CD52 allogeneic edited, intracellular cytokine signaling containing, CAR T cell product
15733063|NCT05000450|Biological|ALLO-647|ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
15733064|NCT05000450|Drug|Fludarabine|Chemotherapy for lymphodepletion
15733065|NCT05000450|Drug|Cyclophosphamide|Chemotherapy for lymphodepletion
15733066|NCT05000437|Other|HIIT|3x/week high intensity interval training for 12 weeks
15733067|NCT05000424|Other|Clary Sage Massage Oil|This massage oil contains clary sage oil. Five drops will be used daily.
15733068|NCT05000424|Other|Inert Massage Oil|This massage oil consists entirely of plant based oils. Five drops will be used daily.
15733069|NCT05000411|Drug|Compound Danshen Dropping Pills (CDDP)|The patients in this group are treated with 20 tablets of Compound Danshen Dropping Pills (CDDP) before primary Percutaneous Coronary Intervention (pPCI) and 10 tablets three times a day after pPCI.
15733070|NCT05000411|Drug|Placebo|The patients in this group take 20 tablets of placebo before primary Percutaneous Coronary Intervention (pPCI) and 10 tablets three times a day after pPCI .
15733071|NCT05000398|Other|Stretching the intrinsic muscles|Participants will be asked to dorsiflex the foot and stretch for 30 seconds. It will be done with 5 repetitions.
15733072|NCT05000398|Other|Thumb Abduction with MTF Joint Traction|participants will be held for 30 seconds by passively abducting the thumb within the limits of pain, and will be applied with 5 repetitions.
15733073|NCT05000398|Other|Thumb active extension exercise|An elastic band will be placed around the thumb, stretching enough to ensure proper alignment of the thumb and passively correct the position. It will be desired to move the feet away from each other without moving the heels from the ground and the extension movement of the thumbs.2 sets will be performed as 10 repetitions. 30 seconds of rest will be given to prevent fatigue between sets.
15733074|NCT05000398|Other|Toe spread out|In the first stage, active finger extension and abduction will be requested while the heel and metatarsal heads are in contact with the ground. In the second stage, while the other fingers are in extension, the smallest finger will be brought laterally and flexed to contact the ground. In the third stage, while in the second stage position, the thumb will be brought into abduction and flexion slowly and contact with the ground will be requested. These 3 phases will be repeated sequentially.2 sets will be performed as 10 repetitions. 30 seconds of rest will be given to prevent fatigue between sets.
15733076|NCT05000398|Other|Heel rise|After taking a 5 cm high tape measure against the wall, the person will be asked to stand up on her heel by at least 5 cm.2 sets will be performed as 10 repetitions. 30 seconds of rest will be given to prevent fatigue between sets.
15743471|NCT04913311|Other|Questionnaire Administration|Ancillary studies
15733077|NCT05000398|Other|Towel toe curl|Patients will be asked to place their feet on the edge of the towel on the floor. An elastic band will be placed around the thumb, stretching enough to ensure proper alignment of the thumb and passively correct the position. Next, they will be asked to grasp the towel with their fingers, flexing their toes, and forcefully dragging them under their feet.2 sets will be performed as 10 repetitions. 30 seconds of rest will be given to prevent fatigue between sets.
15733078|NCT05000398|Other|Gastrocnemius active static stretching exercise|The patient will be placed on the wall at eye level, 50 centimeters away from the wall. The leg that is desired to be stretched will be brought back, while the knee is straight, it will be requested to flex the front leg. During the test, it will be requested that the back heel does not rise from the ground and wait 30 seconds. 5 repetitions to be done
15733079|NCT05000398|Other|Plantar fascia and gastrocnemius stretching exercise on step|The patient will be asked to place both feet on the step and slowly stretch the heel downwards until a stretch is felt in the arch of the foot and wait 30 seconds. 5 repetitions will be done
15733080|NCT05000385|Other|Assesment of masticatory efficiency with optical scanning method|Participants will chew a standardized silicone tablet controlled by the examiner for 20 masticatory strokes. By scanning the comminuted particles, data on each particle size will be obtained. Enhanced masticatory performance is presented by a decrease in the chewed particle areas and an increase in the number of chewed particles.
15733081|NCT05000385|Diagnostic Test|body mass index|as an indication of nutritional status
15733082|NCT05000372|Drug|68Ga-grazytracer|68Ga-grazytracer PET/CT: after intravenous injection of 2.96 MBq/kg body weight of quality-controlled 68Ga-grazytracer, a Siemens Biograph PET/CT scan will be applied within 1 h, and the scan range will be from the top of the head to 1/3 of the upper thigh.
15733083|NCT05000359|Behavioral|text messaging intervention|Ten AYA survivors will be recruited to participate in the expanded 12-week text messaging intervention.
15733084|NCT05000346|Drug|Drug, inhalation|Solution administered by inhalation
15733085|NCT05000333|Other|Self-questionnaire|The study will be proposed to caregivers who work at Centre Hospitalier Intercommunal de Villeneuve-Saint-Georges, who agree to answer the questionnaire anonymously
15733086|NCT05000320|Diagnostic Test|Neuronal Injury Panel|A panel of neuronal and astroglial assays that may be a marker of brain injury.
15733087|NCT05000307|Diagnostic Test|Blood sample|Analysing blood samples for the presence of antibody against SARS-CoV2. When impossible to collect sufficient B-cells for further typing, leucapheresis will be performed if the patient agrees.
15733088|NCT05000294|Drug|Atezolizumab|Subjects on both the phase Ib and phase II portions of this study will receive 1680 mg intravenously of atezolizumab on Day 1 of each 28 day cycle.
15733089|NCT05000294|Drug|Tivozanib|Subjects in both the phase Ib and phase II portions of the study will take tivozanib orally once daily on Days 1-21 of each 28 day cycle. Subjects on the phase Ib will be assigned to receive either 1.34 mg/day (Dose level 0) or 0.89 mg/day (Dose level -1). Subjects in the phase II portion of the study will receive the recommended phase 2 dose determined in the phase Ib portion of the study.
15733090|NCT05000281|Drug|Ibuprofen|600 mg Ibuprofen 3 times a day for up to six weeks.
15733091|NCT05000268|Other|Progressive Myofascial Relaxation Exercise|"Participants will be given telerehabilitation methods, progressive myofascial relaxation techniques and simple posture correction exercises every other day for 2 weeks. The exercises will be performed as follows:
~First, focus on creating tension in the body by contracting all your body muscles and feeling the body tension by holding this tight position for 3-5 seconds. Then relax and relax and focus on feeling the relaxed position of the muscles for 10-15 seconds. Then, the same contraction and relaxation movements will be applied in the feet, legs, hips, waist, chest, shoulders, arms and face areas, respectively. They will be asked to do these exercises in the morning and evening while lying in bed."
15733092|NCT05000255|Behavioral|Intervention 1: According to DGP|The first intervention is designed according to a current recommendation of the Deutsche Pneumologen Gesellschaft e.V. Its approach is resource-oriented, psychoeducational and is expected to have a positive effect on the symptomatology of depression and anxiety in the short and medium term. An additional focus was added to the intervention: planning more physical activity in daily life after discharge. The DPG intervention focuses more on the current state and aims to activate patients' resources in the short and long term. To ensure randomization of study participants, interventions will alternate weekly.
15733093|NCT05000255|Behavioral|"Intervention 2: According to Cacioppo E.A.S.E."|"The second intervention, E. A. S. E. according to Cacioppo and Patrick (2008), addresses the social action radius of patients (here assuming that loneliness is a predictor of depression). This intervention is about planning social activities against loneliness. Cacioppo's intervention aims to encourage more social activity in the long term."
15733100|NCT05000203|Behavioral|Online prenatal specific education|"The sessions will start around 30 weeks of gestation with the intention that around 35-37 weeks all pregnant women have had the opportunity to attend all the sessions.
~Five specific online group sessions have been established for the fear of childbirth, each divided into three parts, and lasting approximately 60 minutes. In the first part, the aspects that are most relevant according to the reported experience of women with fear of childbirth will be discuss. In a second part, videos will be displayed starring midwives who will collaborate in specific intrapartum support with the aim of presenting the personnel involved in the care of women during delivery and immediate postpartum, and where the procedures and options available in the obstetric service of HUMIC. The session will end with brief therapy tasks. After each session, written documentation on the topics discussed will be made available to the participants."
15743472|NCT04913311|Procedure|Spirometry|Under lung spirometry tests
15733101|NCT05000203|Behavioral|Intrapartum specific support|"At first, a group of expert midwives will be formed in support of pregnant women with fear of childbirth. The objective is that three midwives from each work group shift will include the women from the experimental group in the intrapartum support team. The working group will receive a seminar given by the researcher where the study protocol and an update on fear of childbirth will be explained, which will include information on: concept and prevalence, risk factors, consequences, diagnosis and treatment.
~For the follow-up of the participants, an instant messaging group will be formed where the collaborating midwives and the main researcher will be able to find out the existence of a participant within the emergency area or in the maternity ward, facilitating continued care in the changes of guard"
15733102|NCT05000203|Behavioral|Prenatal usual education|The participants in this group will follow the development of the usual interventions by midwives and obstetricians according to the established protocol for monitoring the pregnancy and / or by the private care system, as well as additional consultations for complications in pregnancy or consultations on demand that are considered necessary Group maternal education is offered in primary care center starting at week 28 of gestation. Although its content is supported by the Affective-Sexual and Reproductive Health Care Program, midwives are responsible for preparing the sessions according to their criteria to adapt them to the population. In addition to group interventions, pregnant women in the intervention environment also receive individualized educational attention in follow-up and control visits. After delivery, an inquiry will be made about the maternal education received by pregnant women during their current pregnancy.
15733103|NCT05000203|Behavioral|Intrapartum usual support|A routine detection of fear of childbirth or a protocolized practice for this problem is currently not contemplated in the trial setting. The different professionals who pay their attention to the pregnant woman can detect the fear of childbirth thanks to their experience or different indicators such as the expression of fears by the pregnant woman, being able to offer individualized attention and resources for the approach, according to their awareness of the problem .
15733104|NCT05000190|Dietary Supplement|Active capsule|1 capsule daily for 28 days
15733105|NCT05000190|Other|Placebo capsule|1 capsule daily for 28 days
15733106|NCT05000177|Other|30-minute computer typing task|The subject sits in front of a computer screen and perform computer typing tasks for 30 minutes. The same computer table and chair were used for all subjects. The height of the table and screen, and the distance of the keyboard from the subject were adjusted according to their familiar and comfortable position.
15733107|NCT05000177|Other|30-minute rest|Rest for 30 minutes
15733108|NCT05000164|Device|Bausch + Lomb Ultra® Multifocal for Astigmatism|Study Lens
15733109|NCT05000138|Diagnostic Test|FDG PET/CT|Patients with suspected giant cell arteritis, of which FDG PET/CT is indicated for diagnosis of large vessel involvement, will have the small cranial arteries analyzed for involvement.
15733110|NCT05000125|Diagnostic Test|Hologic's Genius Digital Diagnostics System|Genius Digital Diagnostics is a digital cytology platform to combine a new artificial intelligence (AI) algorithm with advanced volumetric imaging technology to help cytotechnologists and pathologists identify pre-cancerous lesions and cancer cells in women.
15733111|NCT05000099|Other|video calls|A tablet for video-calls will be available for patients and families. Two video-calls of maximum 15' will be organized every week; in addition, patients will be allowed to do video-call upon request. Video-calls will be performed using Skype or WhatsApp video or Face-time
15733112|NCT05000086|Drug|99Tc methylene diphosphonate|22mg qd，Once a day for 7 consecutive days
15733113|NCT05000073|Other|dialysis and socio-aesthetic care|dialysis and socio-aesthetic care
15733114|NCT05000073|Other|dialysis|dialysis
15733115|NCT05000060|Other|Timing/1 week|Time of restart of antiplatelet therapy is one week after injury
15733116|NCT05000060|Other|Timing/3 weeks|Time of restart of antiplatelet therapy is left to treating clinician discretion
15733117|NCT05000047|Device|Natus Otoscan 3D ear scanner|A commercially-available ear scanning device used according to standard of care.
15733118|NCT05000047|Other|Conventional silicon ear impressions|A two part silicon impression material that is used to fill the ear and produce a physical cast of the ear canal. The procedure is standard of care.
15733119|NCT05000034|Procedure|Weaning protocol|Application of a weaning protocol from the mechanical ventilation
15733120|NCT05000021|Behavioral|Telemedicine-Delivered Cognitive Behavioral Therapy|Treatment and control arm participants will wear CGM throughout the CBT intervention period of 12 weeks plus 2-week run-in and 2-week post-intervention periods for a total of 6 months of CGM wear. Ecological momentary assessments (EMA) of DD, mood states, and self-management behaviors will be paired with CGM during the 2-week run-in and post-intervention periods. During the 2-week run-in and post-intervention periods, EMA surveys will be elicited daily to assess for certain domains of diabetes distress and diabetes self-management, which may vary on a daily basis. During the intervention period of 12 weeks, EMA will be delivered once per week prior to CBT sessions to allow for integration with CGM review during therapy. These intensive longitudinal assessments during the 12-week intervention period will guide treatment tailoring and during the first 6 months will facilitate examination of within-person change in diabetes distress, self-management, and CGM glucose over time.
15733121|NCT05000008|Other|Exercises|Moderate aerobic and resistance exercise programe
15733122|NCT04999982|Other|Screening|Parent-report screening for remediable, unmet social needs.
15733123|NCT04999982|Other|Resource Packet|"Provision of packet of resource sheets (Family Resource Booklet) detailing local community-based resources to address these needs, with needs that respond to family's requests highlighted."
15733124|NCT04999982|Other|Resource Navigation|Navigation to resources, care coordination, and parent support provided by a trained bachelors-level interventionist.
15733125|NCT04999982|Other|Care as usual|Screening for social needs annually at well-child visits as recommended by the AAP followed by provision of information as needed by the family.
15733126|NCT04999969|Drug|AZD0171|AZD0171
15733127|NCT04999969|Drug|Durvalumab|Durvalumab
15733128|NCT04999969|Drug|Gemcitabine|Chemotherapy (Standard-of-Care)
15733129|NCT04999969|Drug|Nab-paclitaxel|Chemotherapy (Standard-of-Care)
15733130|NCT04999956|Procedure|dynamic navigation|immediate implant placement using dynamic navigation
15733131|NCT04999956|Procedure|freehand|immediate implant placement using freehand
15733651|NCT04995653|Drug|SER-155 Placebo|Once daily dosing with SER-155 placebo
15733132|NCT04999943|Biological|DC vaccine|EDC cell therapy collection and administration process. Collection of PBMC for preparation of DC cells for patients with autologous DC cells, patient PBMC was collected 10-16 weeks before administration for the preparation and large-scale culture of DC cells. For the patients with matched DC cells, a small amount of peripheral blood was taken for HLA typing 4 weeks before administration, and then the matched DC cells were cultured on a large scale.
15733133|NCT04999930|Device|Aerochamber|efficacy and patients satisfaction
15733134|NCT04999917|Diagnostic Test|high-resolution PET-CT specimen imaging.|"A single intravenous injection of 18F-FDG (0.80 MBq/kg) is given between 30 minutes and 3 hours before tumor resection.
~Surgical resection of the breast tumor (= main specimen) under general anesthesia.
~The main specimen is imaged using the Aura 10 PET-CT Specimen Imager (XEOS Medical, Ghent, Belgium). In case of positive margins, the surgeon will perform oriented cavity shaving. The cavity shaves and lymph nodes (if any) are also imaged using the Aura 10 PET-CT Specimen Imager (for scientific purposes only).
~The main specimen and if applicable the cavity shaves and lymph node(s) are processed following standard-of-care routine: from tissue samples to HE-stained and IHC-stained sections. The histopathological margin status shall be reported according to the ASCO-CAP guidelines, and shall be compared to the PET-CT images of the resected specimens."
15733135|NCT04999904|Other|Uneven Treadmill Intervention|Progressive proprioceptive training on the uneven treadmill with up to twelve training sessions. Subjects will be advanced through activities with progression pragmatically assessed by the physical therapists for the benefit and tolerance of the individual subject. Activities may include: slow walking, fast walking, inclined/declined walking, head turning, vision obstruction, dual task walking, fatigued walking, load carriage. Standard of care physical therapy is still provided.
15733136|NCT04999904|Other|Standard of Care Physical Therapy|Standard of Care Physical Therapy
15733137|NCT04999891|Other|Neurocognitive tests|Battery of neurocognitive tests and questionnaires including MoCA, PHQ-9, Falls History, FIFE, STOPBANG, Nutritional Survey, Global Physical Activity Questionnaire, Brief Pain Index, NuDESC, 3D-CAM.
15733138|NCT04999878|Drug|Ruxolitinib, Etoposide, Dexamethasone, Gemcitabine, Pegaspargase, cis-platinum|"All enrolled patients will receive a regimen containing Ruxilitinib, Etoposide, Dexamethasone, Gemcitabine, Pasparase and Platinum for 28 days. The specific medication is as follows:
~Ruxilitinib 10 mg, bid, d1-28, P.O. Etoposide 100mg per week, two weeks, ivgtt Dexamethasone, 15mg/(m²·d)，d1-12，10 mg/ (m²·d) ，d13-14，5 mg/ (m²·d) ，d15-21，2.5mg/(m²·d)，d22-28，ivgtt or P.O.
~Gemcitabine, 0.5 g/m², d8, ivgtt Pegaspargase, 2500IU/m², d9, im Platinum, 20mg/m² d10 d11, ivgtt After the treatment, patients will be given disease specific chemotherapy regimen to treat lymphoma according to patient's different lymphoma subtype."
15733139|NCT04999865|Other|4-part educational program to build patient-engagement methodology capacity|We created four online training sessions. Our first training for patients/caregivers only (Research 101) was an exception, however, in which we produced a 25-minute asynchronous, self-directed learning seminar intended to be viewed before the subsequent interactive PCOR sessions. Of the three following synchronous interactive training sessions, two included both learner working groups (patients/caregivers and researchers/providers) together (PCOR 101 and PCOR Team Dynamics) and one session (PCOR Study Design) was for researchers/healthcare providers only.
15733146|NCT04999826|Procedure|Biospecimen Collection|Undergo biospecimen collection
15733147|NCT04999826|Other|Quality-of-Life Assessment|Ancillary studies
15733148|NCT04999826|Other|Questionnaire Administration|Complete questionnaires
15733149|NCT04999813|Combination Product|Comprehensive intensive intervention|"Health education ② Medication guidance: antihypertensive therapy, hypoglycemic therapy, lipid-lowering therapy
~Diet guidance: A healthy diet requires low-salt, low-oil, more fruits and vegetables, more cellulose, appropriate amount of protein, restricted fat and cholesterol foods, etc. Quit smoking, drink less alcohol, and limit alcohol intake.
~Exercise guidance: Do aerobic exercises of medium and low intensity at least 5 times a week, and exercise for at least 30 minutes each time.
~Weight loss guidance."
15733150|NCT04999800|Drug|Pembrolizumab|Pembrolizumab (formerly lambrolizumab, brand name Keytruda) is a humanized antibody used in cancer immunotherapy. This includes to treat melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, an stomach cancer
15733151|NCT04999800|Drug|Anlotinib|Anlotinib is an oral small molecule multi-target receptor tyrosine kinase inhibitor
15733152|NCT04999787|Drug|HSK21542|HSK21542-0.3 μg/kg，HSK21542-0.6 μg/kg
15733153|NCT04999787|Drug|Placebo|Placebo
15733154|NCT04999774|Diagnostic Test|Different diagnostic tests|Each SAC will be tested with all tests
15733155|NCT04999761|Drug|AB122|AB122 will be administered with 240 mg/body given by infusion over 60 minutes Q2W.
15733156|NCT04999761|Drug|AB122|AB122 will be administered with 360 mg/body given by infusion over 60 minutes Q3W.
15733157|NCT04999761|Drug|AB122|AB122 will be administered with 240 mg/body given by infusion over 60 minutes Q2W.
15733158|NCT04999761|Drug|TAS-116|TAS-116 will be administered orally in 5-day on and 2-day off schedule on an empty stomach at least 1 hour before or 2 hour after eating.
15733159|NCT04999761|Drug|AB122|AB122 will be administered with 240 mg/body given by infusion over 60 minutes Q2W.
15733160|NCT04999761|Drug|TAS-116|TAS-116 will be administered orally in 5-day on and 2-day off schedule on an empty stomach at least 1 hour before or 2 hour after eating.
15733161|NCT04999735|Behavioral|CHDR Monitoring Remotely (MORE)|CHDR MORE is a highly customizable platform which allows remote monitoring of patients and trial subjects, data ingestion, and data management. The current infrastructure includes an Android app to unobtrusively collect data from smartphone sensors, and a connection to the Withings Health online platform to collect wearable data. Data is stored on a secure server in a structured data scheme ensuring clear data management processes, forming a prerequisite for comprehensive data analysis. The Android app enables data collection from multiple smartphone sensors (e.g. location data, accelerometer and ambient light) as well as phone usage logs (e.g. app usage, calls and texts).
15733162|NCT04999735|Behavioral|Withings Steel HR|The Withings Steel HR is a commercially available smartwatch that combines various sensors to measure activity (steps, sleep, etc.) and heart rate (HR). HR is measured using a PPG (photoplethysmogram, i.e. optically obtained volumetric measurement) based on a commercially available sensor (AS7000) incorporating low-noise and high-sensitivity analogue circuitry. The manufacturer supplies the algorithm for converting the PPG signal into HR values. Data is transferred from the watch to the smartphone using the Withings Health Mate app from where it will be uploaded to the output server.
15733163|NCT04999735|Behavioral|Withings Body+ scale|Body composition (weight, BMI and Skeletal Muscle Mass) can be assessed with the Withings Body+ smart scale at home. A smart phone is required to store data and send collected data to the output server. The device does not require charging.
15733164|NCT04999735|Behavioral|Withings Blood Pressure Monitor|Blood pressure can be assessed with the automated Withings Blood Pressure Monitor at home. A smart phone is required to store data and send collected data to the output server. The device does not require charging
15733165|NCT04999722|Behavioral|Traditional mode of management|Traditional model management of Diabetes Mellitus patients
15733166|NCT04999722|Behavioral|Mobile APP management|Management of diabetic patients with mobile phone APP
15733167|NCT04999709|Device|VeNS|The VeNS device utilizes a technology called galvanic vestibular stimulation (GVS) (sometimes termed vestibular nerve stimulation (VeNS)). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day.
15733168|NCT04999696|Procedure|radical hysterectomy|To compare disease-free survival and overall survival of patients with early stage cervical cancer undergoing total laparoscopic radical hysterectomy versus total abdominal radical hysterectomy
15733169|NCT04999683|Dietary Supplement|ITIS diet|anti-inflammatory diet for 14 days
15733170|NCT04999670|Procedure|Fascial closure method during caesarean section via pfannenstiel incision.|Comparison of three different methods of fascial closure.
15733171|NCT04999657|Device|Non-invasive low-frequency tibial nerve stimulator (TNS-01)|The investigational device is a transcutaneous electrical nerve stimulation (TENS) device that is designed to provide stimulation to the nerves at the site of application via surface electrodes temporarily adhered to the skin.
15733172|NCT04999644|Drug|Full Nicotine Cigarettes|A full nicotine tobacco cigarette that will be smoked by participants
15733173|NCT04999644|Drug|Reduced Nicotine Cigarettes|A reduced nicotine tobacco cigarette that will be smoked by participants
15733174|NCT04999644|Behavioral|Average Nicotine Expectancy|"Participant instructed the cigarette is the same level of nicotine as your usual brand."
15733175|NCT04999644|Behavioral|Very Low Nicotine Expectancy|"Participant instructed the cigarette is a very low level of nicotine compared to your usual brand."
15733177|NCT04999618|Drug|Haemoblock|Delivering with transdermal patches
15733178|NCT04999605|Drug|AK112 low dose|AK112 injection low dose+ olaparib (Lynparza®) PARP inhibitor
15733179|NCT04999605|Drug|AK112 medium dose|AK112 injection medium dose+ olaparib (Lynparza®) PARP inhibitor
15733180|NCT04999605|Drug|AK112 high dose|AK112 injection high dose+ olaparib (Lynparza®) PARP inhibitor
15733181|NCT04999592|Drug|Standard of care without prophylaxis|Administer antibiotics in response to infection
15733182|NCT04999592|Drug|Antibiotic prophylaxis|Ceftriaxone 2 gm IV q12h for 3 days
15733183|NCT04999579|Device|T scan|Occlusal load analysis
15733184|NCT04999553|Device|Repetitive Transcranial Magnetic Stimulation|rTMS will employ the MagPro X100/R30 stimulator equipped with the cool-B70 as we used a cool-B70 in our past non-inferiority trial. The dose will be a 120% rMT in accordance to our latest trial using iTBS. The target area to stimulate will be the right dorsolateral prefrontal cortex (DLPFC) for LFR and the left DLPFC for iTBS as established in prior clinical trials. The localization of both targets will follow the well-established procedures for either R-DLPFC or L-DLPFC using a heuristic method.
15733185|NCT04999553|Device|Intermittent Theta Burst Stimulation (iTBS)|Intermittent Theta Burst Stimulation (iTBS)
15733186|NCT04999553|Device|Low Frequency Right (LFR)|Low Frequency Right (LFR)
15733187|NCT04999540|Drug|Tucidinostat|30 mg, administered orally twice per week (BIW)
15733188|NCT04999540|Drug|Fulvestrant|Fulvestrant was supplied as a castor oil based solution in clear neutral glass pre-filled syringes. Each syringe will contain 250 mg of fulvestrant in 5 ml.
15733191|NCT04999514|Behavioral|Mindful Parenting, Tuning in to Kids|The Mindful Parenting program consists of 8 weekly 2.5-hour group sessions and 3 weekly individual telephone interview sessions (each lasts for around 15-20 minutes). Program materials are translated into Chinese by local partners of the program developer. The Tuning in to Kids program consists of 8 weekly sessions, each lasting for 2.5 hours. Program materials are translated into Chinese.
15733192|NCT04999501|Other|Prolonged resistance-type exercise training|All volunteers will be subjected to 12 weeks of whole-body resistance-type exercise training (3x/wk).
15733193|NCT04999488|Drug|BPM31510|A total of 3200 mg of BPM 31510 or placebo will be self-administered daily by subjects before the morning, afternoon, and evening meals, with no fewer than 4 and no more than 6 hours elapsed between doses during the daytime.
15733194|NCT04999488|Other|Placebo|A total of 3200 mg of BPM 31510 or placebo will be self-administered daily by subjects before the morning, afternoon, and evening meals, with no fewer than 4 and no more than 6 hours elapsed between doses during the daytime.
15733195|NCT04999462|Other|Full-fat fermented dairy|Subjects assigned to the full-fat fermented dairy condition will consume 1 serving/d each of full-fat yogurt (plain or reduced sugar varieties) and full-fat fermented cheese.
15733196|NCT04999462|Other|Low-fat fermented dairy|Subjects assigned to the low-fat fermented dairy condition will consume 1 serving/d each of low-fat yogurt (plain or reduced sugar varieties) and lower-fat fermented cheese (e.g., reduced-fat or low-fat fermented cheese).
15733277|NCT04998799|Behavioral|Current clinical practices of participating physicians|Current clinical practice of participating physicians on management of antithrombotics for COVID-19 during hospitalisation and post-discharge
15733197|NCT04999462|Other|Non-dairy, non-fermented foods|Subjects assigned to the control condition will consume 2 servings/d of nondairy, nonfermented foods with a macronutrient composition that is similar to that of the low-fat fermented dairy condition.
15733198|NCT04999449|Drug|Scopolamine|Intranasal scopolamine at 0.2 mg or 0.4 mg
15733199|NCT04999449|Drug|Placebo|Intranasal saline placebo
15733200|NCT04999436|Behavioral|APOL1 Counseling Training Program|The APOL1 counseling training program is designed for transplant nephrologists who evaluate live kidney donor candidates of African ancestry who are at risk for having APOL1 risk variants and kidney failure post-donation. The training program aims to increase transplant nephrologists' practical knowledge, self-efficacy, and skills in counseling live donor candidates about APOL1 in a culturally competent manner. The program will include training in: current APOL1 data; the value of APOL1 testing and meaning of positive test results for living donor clinical evaluation; risks of having two APOL1 gene variants on the donor's kidney health; how to engage in shared decision making about donation; how to address cultural concerns about genetic testing; and how to protect donor candidates' privacy and confidentiality with APOL1 test results. The APOL1 counseling training program will be delivered by a genetic counselor through webinars and other interactive modalities and last 2-4 hours.
15733201|NCT04999423|Device|LVIS EVO and HydroCoil Embolic System|Stent assisted Coiling
15733202|NCT04999410|Behavioral|High Intensity Interval Training|Interventions will contrast alternative training protocols
15733203|NCT04999397|Other|standards clinical management|outcomes seen in cardiac injuries post clincal care
15733210|NCT04999371|Behavioral|Brief Alcohol Intervention|"The participants in the treatment group received free three-time counsel and constant multi-media messages about the topic of alcohol consumption for three months. One-to-one counseling services will be provided via a telephone call, which is based on World Health Organization (WHO) recommendations. A total of three counsels are conducted, which are set on the second week, sixth and tenth week after the baseline survey.
~Brief intervention counselors are from the team of this study and trained by Hongkong University. All counselors are required to attend a full-day workshop before participant recruitment. The contents of the workshop include (1) knowledge of excessive drinking harms and benefits of controlling drinking; (2) overview of AUDIT; (3) alcohol reduction advice; (4) a standard procedure of brief intervention."
15733211|NCT04999371|Behavioral|Financial Incentive Intervention|The participants in financial Incentive intervention group were conducted by deducting money. Firstly, a certain amount of vouchers were given to the participants, which was equivalent to the reward for passing seven tests. Then, the voucher would be deducted according to every test result. Finally, the participants will receive cash according to the vouchers.
15733212|NCT04999358|Behavioral|Protein education|The protein education session is pre-recorded and will describe in lay terms: the health issues associated with low protein intake, the amount of protein to eat in a day, and provide useful information to increase protein intake. This information will focus on the quality and amount of protein eaten, primarily using a whole-food approach. For example, the education sessions will give ideas for everyday foods that can be added to regular meals, favouring plant proteins, fish, lean meat, poultry, low fat dairy and eggs. The education session has been provided in conjunction with an NHS dietitian.
15733213|NCT04999358|Behavioral|Standard education|Dietary advice provided as part of standard cardiac rehabilitation will be pre-recorded and provided to the control group. This education session will be in addition to usual care.
15733214|NCT04999345|Other|Rehabilitation|Progressive resistance exercise and graded aerobic exercise will be provided for those in the experimental group.
15733215|NCT04999345|Other|Health education|Health education and gross joint range of motion exercise for bilateral upper and lower extremities will be provided for those in the control group.
15733216|NCT04999332|Drug|leucovorin, oxaliplatin, docetaxel, S-1|Perioperative chemotherapy with LOTS
15733217|NCT04999319|Procedure|PVB|Paravertebral block will be performed before the surgery with 20 mL of %0.5 bupivacaine at T4 level.
15733218|NCT04999319|Procedure|ESPB|Erector spinae plane block will be performed before the surgery with 20 mL of %0.5 bupivacaine at T4 level.
15733219|NCT04999306|Behavioral|Hypnosis|one weekly session during 6 weeks (6 sessions of 30min/1 hour).
15733220|NCT04999306|Behavioral|CBT|one weekly session during 6 weeks (6 sessions of 1 hour).
15733221|NCT04999293|Drug|Ticagrelor|Patients were survivors and treated with DAPT (aspirin [100 mg once daily], cilostazol, or indobufen)combined with a P2Y12 receptor antagonist [clopidogrel (75 mg once daily) or ticagrelor (90 mg twice daily)]) at the time of hospital discharge.All patients were followed for 1 year in the outpatient clinic after hospital discharge.
15733222|NCT04999280|Other|Fiber Croissant (FIBCRO) Group|Subjects will consume for 2 weeks at breakfast a fiber-enriched sourdough croissant. All subjects will be requested not to change other dietary habits and their physical activity during the 2 week intervention period.
15733223|NCT04999280|Other|Control Croissant (CONCRO) Group|Subjects will consume for 2 weeks at breakfast a sourdough croissant. All subjects will be requested not to change other dietary habits and their physical activity during the 2 week intervention period.
15733224|NCT04999267|Other|INVEST|The intervention will consist of 3 primary components: 1) school nurse training and technical support for promoting adolescent vaccination (Tdap, MenACWY, HPV) and strengthening existing school nursing vaccination programming, 2) caregiver-targeted educational materials that are disseminated via school nurses, and 3) tools and resources to facilitate linkage to vaccination providers in the local community. Existing materials will be used in the intervention such as resources available from the Centers for Disease Control and Prevention and Middle School Health Starts Here tool kit from the National Association of School Nurses and the National HPV Roundtable. Technical support includes the study team working with local school nurses to identify educational materials available from national and statewide sources.
15733278|NCT04998786|Drug|Ixazomib|Ixazomib 3 mg/day (days 1, 8, 15) cycle 1 to until progress
15733279|NCT04998786|Drug|Iberdomide|Iberdomide 1.6 mg / day (day 1 to 21) cycle 1 to until progress
15733225|NCT04999254|Other|Medical treatment|"Medical treatment will be based on functional treatment and the doctor will prescribe the RICE protocol. For this, the patient will have to :
~place an ice pack on the sprain
~apply sports rest for three weeks
~compress the sprain with a compression stocking when standing in order to prevent phlebitis. In addition, to avoid this complication, the doctor will prescribe an anticoagulant.
~raise the foot with crutches during the day
~elevate the foot at night or when doing an activity in a sitting position, using a cushion for example.
~In addition, the doctor will prescribe anti-inflammatory drugs to ease the pain and physiotherapy to establish proprioception, muscle strength, joint range and dynamic postural balance of the sprain."
15733226|NCT04999254|Other|osteopathic treatment|Each patient will be treated as a whole and within a time limit of 45 minutes. The consultation will start with a medical history followed by medical tests. Then, the osteopath will perform osteopathic tests and manual treatment.
15733227|NCT04999241|Combination Product|exclusive enteral nutrition|Administration of a liquid formula diet with the exclusion of all other regular food for 8 weeks, then patients can administration of regular food.
15733228|NCT04999241|Combination Product|regular food|Administration of regular food in the induction phase and the later time.
15733229|NCT04999228|Drug|Infliximab|Infliximab will be administered intravenously at a dose of 5 mg/kg for 0, 2, and 6 weeks, then every 8 weeks for 1 year.
15733230|NCT04999228|Drug|Corticosteroids|Corticosteroid will be given at a dose of 1-2mg/kg/day (maximum 60 mg/kg/day),oral or intravenously for 12 to 14 weeks.
15733231|NCT04999215|Drug|F-choline intravenous injection|Participants will receive one injection of F-choline before undergoing hybrid PET/CT imaging per standard procedures. F-choline PET examinations may be repeated, if this judged to be in the patient's best interest by his referring physician and the study staff, up to a maximum 4 examinations per year.
15733232|NCT04999202|Drug|BAY2416964|Oral, twice daily.
15733233|NCT04999202|Drug|Pembrolizumab|Administered as a dose of 200 mg using a 30-minute IV infusion every 3 weeks
15733234|NCT04999189|Other|Mobile app forDiabetes (Tessera Multimedia, 2020)|Patients will use a mobile app forDiabetes (Tessera Multimedia, 2020) to manage their disease.
15733235|NCT04999176|Drug|Rivaroxaban|Patients will be submitted to an initial screening evaluation during hospitalization. At discharge, they will be randomized and enrolled to be treated with oral rivaroxaban (10 mg once daily, for 30 days), once randomized to this group. A mandatory lower limb Doppler ultrasound will be carried out on day 30±4 as part of the primary efficacy endpoint. A final follow-up phone call visit will be performed on day 60 postoperative.
15733236|NCT04999176|Drug|Enoxaparin|Patients will be submitted to an initial screening evaluation during hospitalization. At discharge, they will be randomized and enrolled to be treated with subcutaneous enoxaparin (40 mg once daily, for 30 days), once randomized to this group. A mandatory lower limb Doppler ultrasound will be carried out on day 30±4 as part of the primary efficacy endpoint. A final follow-up phone call visit will be performed on day 60 postoperative.
15733237|NCT04999163|Device|Aortix System|Aortix is indicated as a partial circulatory support device to increase renal perfusion and reduce the incidence of acute kidney injury (AKI) in patients undergoing abdominal or cardiac surgeries who are at heightened risk of developing AKI.
15733238|NCT04999150|Procedure|Micro-Osteoperforations|"MOPs were performed with a stainless-steel manual drill tip that had 1.6mm diameter with an adjustable depth set to 5mm (Excellerator® RT; Propel Orthodontics, Milpitas, CA).
~Six perforations were made along 2 parallel vertical lines (each line with 3 holes spaced ~2mm apart) distal to the canine and perpendicular to the buccal cortical bone.
~The mini-screws were placed. A NiTi closed-coil spring was placed and secured with a 0.014SS ligature wire at the canine and mini-screw. A Dontrix gauge was used to measure the force (150g)"
15733239|NCT04999150|Procedure|Corticotomy|"A full-thickness labial mucoperiosteal flap was reflected. Two vertical corticotomies (1 mesial and 1 distal to the canine) were performed. The cortical bone was cut 2 to 3 mm below the alveolar crest towards the apex, until bone marrow was exposed.
~Cortical-cancellous bone grafts (0.5cc; PuraGraft, Kingwood, TX) were placed at the corticotomy sites.
~The mini-screws were placed. A nickel-titanium (NiTi) closed-coil spring was placed and secured with a 0.014SS ligature wire at the canine and mini-screw. A Dontrix gauge (Orthopli Corp., Philadelphia, PA) was used to measure the force (150g)"
15733240|NCT04999137|Drug|Vitamin C|Vitamin C (ascor), infused intravenously in 50 mls sodium chloride (NaCl) over 30 minutes every 6 hours for 16 doses
15733241|NCT04999137|Drug|Vitamin B1|Vitamin B1 (200 mg) administered intravenously every 12 hours for 8 doses
15733242|NCT04999124|Other|Screening and studying characteristics|Type 2 diabetes patients have a high risk of developing NAFLD. This was confirmed during previous research, a high prevalence of NAFLD among type 2 diabetes mellitus patients was found. Now we want to determine the characteristics of this population.
15733244|NCT04999098|Drug|Echinaforce Forte tablets|"Tincture of fresh Echinacea purpurea (L) MOENCH: Herba rec. T. aerial part DER = 1:12-13 (Drug to extraction solvent ratio) extraction solvent = ethanol 65.1 % (V/V) = 57.3 % (m/m)* with an approx. dry plant equivalent of 32 mg per tablet Dry weight content in 1 tablet: 5.9 mg
~Echinacea purpurea: (L) MOENCH: Radix rec. root part DER = 1:11-12 (Drug to extraction solvent ratio) extraction solvent = ethanol 65.1 % (V/V) = 57.3 % (m/m)* with an approx. dry plant equivalent of 1.8 mg per tablet Dry weight content in1 tablet: 0.3 mg
~the tablet contain additional excipients"
15733245|NCT04999098|Drug|Echinaforce Chewable tablets|"Tincture of fresh Echinacea purpurea (L) MOENCH: Herba rec. T. aerial part DER = 1:12-13 (Drug to extraction solvent ratio) extraction solvent = ethanol 65.1 % (V/V) = 57.3 % (m/m)* with an approx. dry plant equivalent of 32 mg per tablet Dry weight content in 1 tablet: 5.9 mg
~Echinacea purpurea: (L) MOENCH: Radix rec. root part DER = 1:11-12 (Drug to extraction solvent ratio) extraction solvent = ethanol 65.1 % (V/V) = 57.3 % (m/m)* with an approx. dry plant equivalent of 1.8 mg per tablet Dry weight content in1 tablet: 0.3 mg
~The tablets contain additional excipients"
15733246|NCT04999098|Drug|Echinaforce tincture|"Tincture of fresh Echinacea purpurea (L) MOENCH: Herba rec. T. aerial part DER = 1:12-13 (Drug to extraction solvent ratio) extraction solvent = ethanol 65.1 % (V/V) = 57.3 % (m/m)
~Echinacea purpurea: (L) MOENCH: Radix rec. root part DER = 1:11-12 (Drug to extraction solvent ratio) extraction solvent = ethanol 65.1 % (V/V) = 57.3 % (m/m)"
15733280|NCT04998786|Drug|Dexamethasone Oral|Cycle 1 and 2 Dexaméthasone 20 mg/day on days 1, 8, 15, 22 Cycle 3 to 6 Dexamethasone 10 mg/day on days 1, 8, 15, 22
15733248|NCT04999072|Procedure|Colectomy for colon cancer|Segmental or total colectomy was performed for colorectal cancer.
15733249|NCT04999059|Other|Safety and Efficacy Assessments|Safety evaluations, disease-specific assessments, and other assessments to monitor for long-term complications of gene therapy intervention.
15733250|NCT04999046|Device|NaviFUS System|FUS treatment will be conducted with following exposure parameters: intracranial spatial-peak temporal-average intensity (ISPTA) ceiling level: 2.8 W/cm2 (the focused ultrasound intensity in brain area considering transcranial attenuation), burst length: 3 ms, duration: three consecutive 5-minute FUS exposures with two 5-minute intermission intervals.
15733251|NCT04999033|Other|no intervention|This is a cross-sectional study, and no intervention will be included
15733252|NCT04999020|Drug|Ravulizumab|Intravenous dosing will consist of a loading dose followed by maintenance doses administered every 8 weeks (q8w). The maintenance dosing will be initiated 2 weeks after the loading dose is administered.
15733253|NCT04999020|Drug|Placebo|Intravenous dosing will consist of a loading dose followed by maintenance doses administered q8w. The maintenance dosing will be initiated 2 weeks after the loading dose is administered.
15733254|NCT04999007|Other|Artificial intelligence algorithm|Temporary ileostomy will be performed in the patients with high-risk of anastomotic leakage and not performed in the patients with low-risk of anastomotic leakage.
15733255|NCT04998994|Dietary Supplement|wheat sprouts supplement|Maiji tablets, a wheat sprouts supplement, were used to treat 26 patients during the progress of chemotherapy
15733256|NCT04998981|Drug|K-877 0.1 mg tablet|K-877 0.1 mg tablet x 2 twice daily
15733257|NCT04998981|Drug|Fenofibrate 200 mg capsule|Fenofibrate 200 mg capsule once daily
15733258|NCT04998981|Drug|Placebo tablet|Placebo tablet x 2 twice daily
15733259|NCT04998981|Drug|Placebo capsule|Placebo capsule once daily
15733260|NCT04998981|Drug|K-877 0.1 mg tablet|K-877 0.1 mg tablet twice daily
15733261|NCT04998981|Drug|Placebo tablet|Placebo tablet twice daily
15733262|NCT04998955|Behavioral|Maximal strength training|Exercise intervention utilizing 4 x 4 repetitions heavy resistance training
15733263|NCT04998942|Behavioral|virtual cardiac wellness program|Participants assigned to this arm will participate in the experimental intervention.
15733264|NCT04998942|Behavioral|Placebo comparator|Participants assigned to this arm will participate in a placebo intervention.
15733265|NCT04998929|Other|complementary therapy|traditional techniques of treatment including, (a)cupping therapy, (b)Backstroke for young people, (c)Sitting on all fours while the other person holds both knees firmly with the hands, the patient is asked to bend at the back so that the abdominal muscles are stretched, (d)taking a nerve that passes under the armpit with two index fingers and thumbs and applying intense pressure to the extent that the patient goes unconscious due to the severity of the pain, (e)Hanging the patient from the horizontal bar and stretching the abdominal muscles, (f)Tie an onion-sized object such as, a bag of wheat or salt, with a scarf on the navel for one hour, (g) taking the gum of mountain pistachio tree which is the same as turpentine and halve a walnut and fill it with raw turpentine and put it inside the navel for 72 hours, and then move it in the umbilical region by twisting hand movements, (h)cupping therapy.
15733266|NCT04998916|Device|Real TBS to the mPFC|This will be delivered with the Magventure Magpro system; 600 pulses of continuous theta burst stimulation with the active sham coil (double blinded using the integrated active sham system).
15733267|NCT04998916|Device|Sham TBS to the mPFC|This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the integrated active sham system). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the scalp. The electrodes are placed on the left frontalis muscle under the coil for both the real and sham stimulation sessions.
15733268|NCT04998903|Procedure|Fiberoptic Bronchoscopy|Fiberoptic bronchoscopy done under conscious sedation
15733269|NCT04998890|Other|adventure-based cognitive behavioral intervention|"The adventure-based cognitive behavioral intervention is a combination of cognitive behavioral therapy and adventure training. The intervention program is delivered in a 39-hour general education course entailed Improving Mental Health for University Success in a public university in Hong Kong. The program includes 6 lectures, 5 workshops, 5 adventure games and an adventure day camp. Students are divided into two groups in workshop to practise CBT skills to deal with their own issues."
15733270|NCT04998864|Device|Magnetic Resonance guided Focused ultrasound (MRgFUS)|FUS involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct body targets.
15733272|NCT04998838|Drug|Tenofovir Disoproxil Fumarate 300 mg daily; HBV birth dose vaccine; hepatitis B immune globulin (HBIG)|Antenatal screening for HBV, anti-viral treatment with tenofovir according to treatment eligibility criteria, and birth dose vaccination at delivery to prevent mother-to-child transmission of HBV
15733273|NCT04998838|Drug|Regular Myanmar treatment|Treated according to normal Myanmar processes for HBV positive patients
15733274|NCT04998825|Dietary Supplement|Proteoglycan F|Salmon proteoglycan (Proteoglycan F) was extracted from salmon (Oncorhynchus keta) nasal cartilage. Salmon cartilage PG (Proteoglycan F) was manufactured in the form of a hard capsule by Ichimaru Pharcos, Co., Ltd. (at 318-1 Asagi, Motosu-shi, Gifu 501-0475 Japan) and consisted of 50 mg proteoglycan.
15733275|NCT04998825|Other|Placebo product|The placebo capsule contained only dextrin powder (Ichimaru Pharcos, Co., Ltd.).
15733276|NCT04998812|Drug|Ocrelizumab|Post-partum dosing and treatment duration are at the discretion of the physicians, in accordance with local clinical practice and local labelling.
15733281|NCT04998773|Device|Theta Burst Transcranial Magnetic Bilateral Stimulation|TMS protocol of 22 sessions of bilateral active 1800 pulses.
15733282|NCT04998773|Device|Theta Burst Transcranial Magnetic Sham Stimulation|TMS protocol of 22 sessions of sham bilateral 1800 pulses.
15733283|NCT04998773|Device|Theta Burst Transcranial Magnetic Unilateral Stimulation|TMS protocol of 22 sessions of left active 1800 pulses and right sham 1800 pulses.
15733284|NCT04998760|Drug|ATG-008|ATG-008 will be orally administered at 30 mg QD combined with chemotherapies. And about 8-12 subjects plan in each cohort.
15733285|NCT04998760|Drug|ATG-010|ATG-010 will be orally administered at 30 mg QD and 80 mg QW combined with chemotherapies. And about 8-12 subjects plan in each cohort.
15733288|NCT04998734|Diagnostic Test|ASI-SR|Psychometric properties of ASI-SR
15733289|NCT04998721|Behavioral|Promoting First Relationships-Brief|A brief version of the evidence based Promoting First Relationships (PFR) parenting intervention in which a parent is supported in appropriate interpretation of infant cues and in developing skills to effectively parent an infant. Sessions consist of reflective content (observing and reflecting back to the mother on patterns of dyadic interaction) and informational handouts. Reflective content will be delivered in person, and text messaging protocol will deliver informational content at developmentally appropriate times. PFR-B sessions are delivered in primary care settings beginning in the third trimester and continuing postpartum.
15733290|NCT04998721|Combination Product|Perinatal Collaborative Care|Collaborative Care (CC) is an integrated care model that is effective in the treatment of perinatal depression. CC provides team driven, population focused, measurement guided and evidence based care to improve access and outcomes, control costs, and increase patient satisfaction.
15733291|NCT04998708|Other|Relaxation technique|The intervention group performed two types of relaxation techniques, that have shown their positive effects on immune functions, including progressive muscle relaxation exercise (PMRs)16 and cognitive-behavioral stress management (CBSM)32. We used two types of relaxation techniques to produce maximum effects of relaxation techniques within the limited period of COVID-19 quarantine (2 weeks). the control groups did not receive any treatment during the study; however, they were treated afterwards.
15733292|NCT04998695|Other|Olive pomace oil|Volunteers consumed during 4 weeks 45 g/d of olive pomace oil as the only source of dietary fat, used for cooking, salad dressing, toasts, etc.
15733293|NCT04998695|Other|Sunflower oil|Volunteers consumed during 4 weeks 45 g/d of sunflower oil as the only source of dietary fat, used for cooking, salad dressing, toasts, etc.
15733294|NCT04998682|Procedure|Axillary Dissection|A surgical procedure that opens the armpit (axilla) to identify, examine, or remove lymph nodes. Axillary dissection will be performed during SoC breast cancer surgery.
15733295|NCT04998669|Drug|Loncastuximab tesirine|"Induction Phase (Cycles 1 through 4):
~150 μg/Kg of loncastuximab tesirine administered via intravenous infusion (given as per treatment guidelines) on Days 1 of a 3-week cycle during Cycles 1 and 2.
~75 μg/Kg of loncastuximab tesirine administered via intravenous infusion (given as per treatment guidelines) on Days 1 of a 3-week cycle during Cycles 3 and 4.
~Maintenance Phase 1 (Cycle 5): For participants achieving CR or PR, 75 μg/Kg of loncastuximab tesirine administered via intravenous infusion (given as per treatment guidelines). on Day 1 on Week 1, 4, 7 of a 8-week cycle.
~Maintenance Phase 2 (Cycle 6 & 7): For participants achieving PR, 75 μg/Kg of loncastuximab tesirine administered via intravenous infusion (given as per treatment guidelines) on Day 1 on Week 1, 4, 7 of a 8-week cycle."
15733296|NCT04998669|Drug|Rituximab|"Induction Phase (Cycles 1 through 4): 375 mg/m2 rituximab on days 1, 8, 15 of cycle 1 and day 1 of cycle 2 via intravenous infusion (given as per treatment guidelines) or subcutaneous 1400 mg/23,400 units hyaluronidase during Cycles 1 and 2, per discretion of treating physician. Rituximab will not be administered during Cycles 3 and 4.
~Maintenance Phase 1 (Cycle 5): Participants achieving a response of PR or CR will receive 375 mg/m2 rituximab during week 7 or 8 of a 8-week cycle via intravenous infusion (given as per treatment guidelines) or subcutaneous 1400 mg/23,400 units hyaluronidase, per discretion of treating physician.
~Maintenance Phase 2 (Cycles 6 and 7): Participants achieving a response of PR or CR will receive 375 mg/m2 rituximab during week 7 or 8 of each 8-week cycle via intravenous infusion (given as per treatment guidelines) or subcutaneous 1400 mg/23,400 units hyaluronidase, per discretion of treating physician."
15733297|NCT04998656|Device|Werewolf FLOW 50|Use of Werewolf FLOW 50 electrocautery device during surgical treatment for ACL injury. This device is often used as standard of care when our other standard of care approach (use of no electrocautery device) is not used.
15733298|NCT04998656|Other|Control|Use of no electrocautery device during surgical treatment for ACL injury. This approach is often used as standard of care when our other standard of care approach (use of Werewolf FLOW 50 electrocautery device) is not used.
15733299|NCT04998643|Diagnostic Test|Muscle ultrasound to estimate lean body mass|The investigators will perform serial muscle ultrasounds in the postoperative period to estimate lean body mass.
15733300|NCT04998630|Device|Extracorporeal shockwave therapy|Treatment Location: Painful Area Treatment intensity: 2000 pulses, low energy (0.08~0.28 mJ/m2) the degree to which the subject can tolerate
15733301|NCT04998617|Other|Toothpaste with curcumin|Subjects will be given toothpaste to be used during this study with 0.5% curcumin
15733302|NCT04998617|Other|Toothpaste without curcumin|Subjects will be given toothpaste to be used during this study without curcumin
15733303|NCT04998604|Drug|Dupilumab|solution for injection subcutaneous
15733304|NCT04998604|Drug|Omalizumab|solution for injection subcutaneous
15733305|NCT04998604|Drug|Placebo|solution for injection subcutaneous
15733306|NCT04998591|Behavioral|Fasting|fasting for 7 days (caloric intake <500 kcal in liquid form)
15733307|NCT04998578|Device|Comparison of aesthetic techniques|Comparison of aesthetic techniques for rejuvenation and glazing of the genital region
15733308|NCT04998565|Other|Routine care|Reverse pressure applied to the areola
15733309|NCT04998565|Procedure|Electrical Acupuncture|Acupuncture on Hegu, Sanyinjiao, Zusanli and Taichong with electrical stimulation
15733310|NCT04998565|Procedure|Transcutaneous Electrical Nerve Stimulation|Transcutaneous electrical nerve stimulation over bil breasts
15733311|NCT04998552|Radiation|Cyberknife|5-10 Gy/fraction.Average of 45 minutes every other day for a total of 5 sessions (1.5-2 weeks).
15733312|NCT04998539|Other|Wheelchair forward direction|Participants will move the wheelchair over 5 meters of a soft surface (gym mats) in the forward direction. Participants will push the wheelchair when moving forward.
15733313|NCT04998539|Other|Wheelchair backward direction|Participants will move the wheelchair over 5 meters of a soft surface (gym mats) in the backward direction. Participants will pull the wheelchair when moving backwards.
15733314|NCT04998539|Other|Upright technique|Participants will move the wheelchair across the 5 m soft surface using the upright technique. The upright technique involves the wheelchair being moved with all 4 wheels on the ground.
15733315|NCT04998539|Other|Wheelie technique|Participants will move the wheelchair across the 5 m soft surface using the wheelie technique. The wheelie technique involves the wheelchair being tipped backward and balanced on the rear wheels. Participant wheelchair occupants will always be upright when being moved using the wheelie technique.
15733316|NCT04998539|Other|Wheelchair occupant upright body position|The participant occupying the wheelchair (wheelchair occupant) will be seated with a body position that is upright (back is leaning against the wheelchair back rest and arms on wheelchair arm rests) while the wheelchair is being moved.
15733317|NCT04998539|Other|Wheelchair occupant forward body position|The participant occupying the wheelchair (wheelchair occupant) will be seated with a body position that is leaning forwards (trunk resting on thighs and hands holding lower legs) while the wheelchair is being moved.
15733318|NCT04998526|Other|Experimental group|The cold gel pack will be applied to the nape.
15733319|NCT04998526|Other|Placebo group|The gel pack kept at room temperature will be applied to the nape.
15733320|NCT04998513|Drug|Medical Management Alone Arm|"The medical intervention consists of intravenous dexamethasone (10 mg if bodyweight < 70 kilograms, 20 mg if bodyweight > 70 kilograms), intravenous cefazolin 2 grams, intravenous metronidazole 500 mg, oral probenecid 2 grams, and 1 liter of intravenous crystalloid fluid given over 1 hour.
~If, during the initial post-enrolment day 1 follow-up, patients report a failure of signs and symptoms to improve since their medical therapy, a second round of intravenous crystalloid fluid, cefazolin, probenecid, metronidazole and dexamethasone will be given at the same dose as the initial medical therapy. Failure to improve patient signs and symptoms over a two-hour observation window will prompt surgical intervention to be performed in the same fashion as the surgical intervention group."
15733321|NCT04998513|Procedure|Surgical Arm|"Surgical intervention consists of attempted incision and drainage of the abscess. Specific procedure steps and details are at the discretion of the treating surgeon. In general, incision and drainage consists of topical and submucosal local anesthetic followed by a mucosal incision along the palatoglossal arch and soft palate junction, and blunt dissection of the abscess cavity to evacuate pus. Some surgeons may first perform a needle aspiration. For purposes of the trial, positive aspiration of pus on needle aspiration must be followed by attempted incision and drainage. Failed needle aspiration or surgical drainage will be considered as a failed attempt at surgical intervention.
~Patients randomized to receive surgical intervention will also receive medications as per the medical management arm."
15733322|NCT04998500|Biological|Growth hormone, saline and GH receptor blockade (Pegvisomant)|This study aims to uncover physiological effects of growth hormone (GH). The intervention with GH and GH receptor blockade (Pegvisomant) will therefore be used as tools to activate a well-known physiological response. Thus, this study is not a drug trial.
15733323|NCT04998487|Drug|LY3471851|Administered SC.
15733324|NCT04998474|Biological|FRAME-001 personalized vaccine|Patients will receive personalized peptide vaccine FRAME-001 based on frame-shift mutations (Frames) detected by Whole Genome Sequencing (WGS)/Ribonucleic Acid sequencing (RNAseq) in a tumor biopsy. FRAME-001 vaccine will be administered in four sequential cycles at 3-week interval (Q3W), along standard maintenance monotherapy of pembrolizumab (administration Q3W or Q6W). Each cycle will be consisting of up to four subcutaneous injections at up to four different sites in the upper and lower limbs.
15733325|NCT04998461|Biological|urine collection|To isolate urine stem cells, a sample of 30ml minimum an 100ml maximum as a function of the patient, will be collected in a single time in a sterile flask during collection for the nephrologic exams. A transcriptome analysis of USC will be performed.
15733326|NCT04998435|Procedure|Erector Spinae Plain Block|"Using aseptic technique, ultrasound-guided ESPB will be performed with the patient in sitting position. The spinous process of the vertebra and a point 3 cm lateral to it will be marked before performing the block. The needle will be inserted and advanced under sono-visualization to contact the transverse process of the vertebra. After negative aspiration, LA will be deposited into the fascial plane deep to erector spinae muscle.
~30 ml of Bupivacaine 0.25% will be used as LA, injected using a 22-gauge spinal needle at the level of T10 which will be identified by counting 3 spinous processes below T7 which is at the level of the inferior angle of the scapula and also rechecked by counting down from C7.
~Patients will then receive general anesthesia. All patients will receive paracetamol (1gm/8hrs IV) as a regular analgesia. IV morphine (0.02mg/kg) will be given as a rescue analgesia if the Visual Analogue Scale for pain is ≥ 4."
15733327|NCT04998435|Procedure|Paravertebral Block|"Using sterile technique, ultrasound scanning of thoracic paravertebral space will be done in sitting position. The transverse process will be identified as hyperechoic structure while pleura will be identified as a mobile hypoechoic structure. The needle will be inserted cranio-caudal and advanced under sono-visualization to the identified thoracic paravertebral space. After negative aspiration, LA will be deposited displacing the pleura.
~30 ml of Bupivacaine 0.25% will be used as LA, injected using a 22-gauge spinal needle at the level of T10 which will be identified by counting 3 spinous processes below T7 which is at the level of the inferior angle of the scapula and also rechecked by counting down from C7.
~Patients will then receive general anesthesia. All patients will receive paracetamol (1gm/8hrs IV) as a regular analgesia. IV morphine (0.02mg/kg) will be given as a rescue analgesia if the Visual Analogue Scale for pain is ≥ 4."
15733328|NCT04998422|Drug|HG381|HG381 is available as white to off-white cake or powder for solution for injection at a unit dose strength of 5 mg per vial. HG381 will be administered as IV injection.
15733329|NCT04998409|Device|Monofocal lens|not applicable as patients are already implanted with the monofocal lens
15733330|NCT04998396|Biological|AAV9 BBP-812|Sterile solution for injection for 1-time use via volumetric infusion pump
15733360|NCT04998110|Other|Ambulatory Supportive Care|Ambulatory supportive care visits monthly for six months - a monthly visit with an ambulatory palliative care provider educated in kidney disease
15733682|NCT04995354|Drug|Hydrogel|Non-medicated self-healing hydrogel to be applied three times a day for 1 week
15733331|NCT04998383|Device|HVNI|High velocity nasal insufflation (Fisher &Paykel, Auckland, New Zealan High-velocity nasal insufflation (Precision Flow;Vapotherm, Inc, Exeter, NH) (Figure 2) using a smallborenasal cannula was initiated with a flow rate set to 35 L/min, with a starting temperature between 35C and 37C and FiO2 at 1.0. Adjustments in flow (up to 40 L/min) and temperature (typically between 35C and 37C) were made to alleviate respiratory distress and optimize comfort.
15733332|NCT04998357|Other|Endovascular autologous mitochondrial transplantation|During standard-of-care endovascular reperfusion procedure, subjects will have autologous mitochondria infused via microcatheter into ischemic brain.
15733333|NCT04998344|Biological|Inactivated influenza vaccine|Vaccines will be administered as a single dose regimen for the pregnant women and two doses for children at 28-day interval as recommended by the vaccine manufacturers.
15733334|NCT04998344|Biological|Inactivated polio vaccine|Vaccines will be administered as a single dose regimen for the pregnant women and two doses for children at 28-day interval as recommended by the vaccine manufacturers.
15733335|NCT04998331|Other|No Intervention|This is a non-interventional study.
15733336|NCT04998318|Device|Pocket Colposcope|Both arms will receive treatment in order to prevent cervical cancer. However, the intervention using the pocket colposcope device will be used on half the enrolled subjects.
15733337|NCT04998318|Procedure|Standard of Care Colposcopy|VIA and VILI as previously described,
15733338|NCT04998305|Drug|TJ-68|For two periods (one period = 2 weeks) during the 11-week participation, participants will take 2.5 g of TJ-68 for three times per day before meals. It will be administered by dissolving 2.5 g of TJ-68 powder in 1 oz. of lukewarm water.
15733339|NCT04998305|Drug|Placebo|For two periods (one period = 2 weeks) during the 11-week participation, participants will take 2.5 g of placebo for three times per day before meals. It will be administered by dissolving 2.5 g of the placebo powder in 1 oz. of lukewarm water.
15733340|NCT04998292|Device|Piezo-surgery with low level laser therapy|Low level laser therapy
15733341|NCT04998292|Device|Piezo-surgery only|Piezo-surgery only
15733342|NCT04998279|Drug|Granulocyte Colony-Stimulating Factor|Granulocyte-colony stimulating factors (G-CSF) is synthesized in the reproductive tract naturally, it is a hematopoietic lineage-specific cytokine which is known for its specific effects on the activation of intracellular signaling pathways that are associated with the cell proliferation, differentiation, and stimulation of hematopoietic cells of the neutrophilic granulocyte lineage; which act on macrophages of decidual cells and finally affect implantation
15733343|NCT04998279|Other|placebo|mock test without injection of G-CSF
15733344|NCT04998266|Other|Performing following WHO (World Health Organization)|The CLA group will perform exercises following WHO (World Health Organization) prescription
15733345|NCT04998266|Other|Performing on their needs|The IND group will perform strength, aerobic or flexibility exercises depending on their needs observed during the first assessment.
15733346|NCT04998253|Drug|Effects in oxygenation and hypoxic pulmonary vasoconstriction|"Determination of the anti-inflammatory effect. The anti-inflammatory effect is assessed with serum measurement of interleukin 6 (IL-6), C-reactive protein (CRP), ferritin, DHL (lactic dehydrogenase), taken by venipuncture on admission, at 24 and 48 hours.
~The following measurements will be performed: pulmonary artery systolic and diastolic pressure (PASP, PADP respectively), central venous pressure (CVP), pulmonary artery occlusion pressure (PAOP), pulmonary vascular resistance (PVR), systemic vascular resistance (SVR), right ventricular stroke work (RVSW) and left ventricular work (LVSW). Stroke volume (and cardiac output) will be computed using the thermodilution technique averaging three consecutive injections with 10 ml of 0.9% saline solution."
15733347|NCT04998240|Biological|BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell)|"The Inactivated SARS-CoV-2 vaccine (Vero cell)- BBIBP-CorV manufactured by Beijing Institute of Biological Products (BIBP), China National Biotec Group (CNBG), Sinopharm, Beijing, People's Republic of China
~Dose formulation: A liquid formulation containing 4μg total protein with aluminum hydroxide adjuvant (0·45 mg/mL) per 0·5 mL (2-dose schedule followed by a booster dose).
~Mode of Administration:
~Intramuscular
~Storage Conditions: 2 to 8' C"
15733348|NCT04998240|Biological|AZD1222 (replication-deficient Ad type 5 vector expressing full-length spike protein)|"AZD1222 (replication-deficient Ad type 5 vector expressing full-length spike protein), manufactured by Oxford University-AstraZeneca in United Kingdom
~Dose formulation: One dose (0.5ml) contains 5 x 1010 ChAdOx1-S (recombinant) viral particles. .
~Mode of administration: Intramuscular
~Storage Conditions: 2 to 8' C"
15733349|NCT04998214|Diagnostic Test|liver function , prothrombin time , INR , US .|analytic
15733350|NCT04998201|Drug|ARO-APOC3|ARO-APOC3 Injection
15733351|NCT04998201|Drug|Placebo|Sterile Normal Saline (0.9% NaCl)
15733352|NCT04998188|Procedure|Collagen|Patients will be treated with a single injection of collagen (2 ml) in the knee joint affected by osteoarthritis
15733353|NCT04998188|Procedure|Placebo (saline solution)|Patients will be treated with a single injections of saline solution (2 ml) in the knee joint affected by osteoarthritis
15733354|NCT04998175|Procedure|ventriculo-peritoneal shunt|A ventriculoperitoneal shunt is a tube that drains excess cerebrospinal fluid into abdomen
15733355|NCT04998162|Procedure|SVF injection|Patients with ankle osteoarthritis will be treated with a single injection of 5 cc of SVF (stromal vascular fraction), obtained from patient's abdominal adipose tissue and concentrated through OPTYFAT device. Infiltration of the ankle, occurs from the safest portal, that is, from the antero- medial, between the tibialis anterior and the saphenous vein and nerve at the level of the articular rima.
15733356|NCT04998149|Device|Peanut Ball positioning device|Peanut Ball manufactured by Clinton industries at graylinemedical.com https://www.graylinemedical.com/products/clinton-industries-peanut-ball-peanut-ball-40-cm-yellow-8540?_pos=3&_sid=d6e52e63c&_ss=r
15733357|NCT04998136|Drug|Semaglutide 2.4 mg|Administered subcutaneously (s.c., under the skin) as well as reduced-calorie diet and increased physical activity for 44 weeks. Doses gradually increased to 2.4 mg
15733358|NCT04998136|Drug|Placebo (semaglutide 2.4 mg)|Administered s.c. as well as reduced-calorie diet and increased physical activity for 44 weeks
15733359|NCT04998123|Device|SeizureStop Device|Intersectional Short Pulse (ISP) Stimulation will be performed using SeizureStop Device. The ISP stimulation method proposed in this study is to increase the intensity of stimulation delivered to targeted brain regions, while minimizing the peripheral effects of stimulation. For sham stimulation, no settings will be modified.
15733743|NCT04994873|Behavioral|STEP|Behavioral intervention to increase positive affect
15733361|NCT04998097|Device|repetitive transcranial magnetic stimulation (rTMS)|Investigators adopted the iTBS protocol which follows the standard TBS protocols, with 3-pulse 50-Hz bursts given every 200 ms (at 5 Hz) and an intensity of 80% motor threshold. In each session, a 2-s train of bursts will be repeated every 10 s for a total of 570 s (1800 pulses) to the left dorsolateral prefrontal cortex (DLPFC). TBS sessions will be scheduled daily in a 5-day sequence, for a total of 10 sessions in 2 weeks.
15733362|NCT04998097|Device|sham repetitive transcranial magnetic stimulation (rTMS)|no stimulation, Sham TBS sessions will be scheduled daily in a 5-day sequence, for a total of 10 sessions in 2 weeks.
15733363|NCT04998071|Drug|Bupivacaine hydrochloride|Analgesic efficiency comparison between two concentration of bupivacaine hydrochloride using for posterior quadratus lumborum block in LPEC
15733364|NCT04998058|Procedure|Maxillary sinus floor elevation grafting with synthetic bone substitute.|Bone augmentation at the floor of the maxillary sinus with bone substitutes.
15733365|NCT04998045|Behavioral|Screening and brief intervention for substance use|Screening will be done using the WHO Alcohol Smoking and Substance Involvement Screening Test (ASSIST). The brief intervention will be delivered based on ASSIST risk scores: low risk - verbal positive reinforcement and brief advice on harmful consequences of substance use (ii) moderate risk - brief motivational interviewing (BMI) (iii) high risk - BMI and referral to child psychiatry out-patient clinic. The BMI will be delivered in a single session (approximately 15 minutes) using Feedback Listen Options model (15): (i) providing feedback on screening results (ii) exploring pros and cons of substance use, enquiring about importance of change (iii) exploring options for change.
15733366|NCT04998032|Biological|supaglutide injection+metformin|supaglutide subcutaneous injection under RP3D dose combined with metformin treatment
15733367|NCT04998032|Other|placebo+metformin|placebo subcutaneous injection combined with metformin treatment
15733368|NCT04998019|Behavioral|PositiveLinks|"The PositiveLinks (PL) patient mobile app delivers appointment reminders, daily queries (check-ins) of mood, stress and medication adherence, tailored educational resources, access to the PL team for individualized assistance, and the opportunity to interact with other users on a secure, anonymous community message board (CMB)."
15733369|NCT04998006|Drug|Alcohol and Cannabis vs. Alcohol only|Self-directed (ad-libitum) cannabis and alcohol vs. self-direct (ad-libitum) alcohol
15733371|NCT04997980|Drug|Amiodarone Injection|
15733372|NCT04997967|Drug|Ketamine/Propofol|The level of sedation was assessed at 1-3 min intervals, and the infusion rate was adjusted accordingly to achieve a Ramsay Sedation Scale (RSS) score of 5. Any movement of the patient was treated by increasing infusion rate and the infusion was discontinued at the end of the procedure. The total propofol consumed was calculated and the recovery time was recorded and calculated as the time from discontinuation of infusion of the study drug till achievement of RSS score of 3. Then patients were discharged to post-anesthesia care unit (PACU) after attaining an Aldrete Recovery Scale Score of 9- 10 [19]. Time taken to achieve this score was also recorded.
15733373|NCT04997967|Drug|Propofol|Sedation was initially started by bolus dose of 0.5 mg/kg propofol IV over 3 minutes then, infusion was started at the rate of 50 µg /kg/min till RSS score of 5.
15733374|NCT04997954|Drug|MediCabilis CBD oil|"The investigational product (MediCabilis 5% (50mg/ml) CBD Oil) will be supplied by BOD Australia, an Australian licensed manufacturer of medical grade cannabis.
~The main components of MediCabilis 5% (50 mg/mL) CBD extract in MCT Oil are:
~Cannabis sativa L. dry extract
~Medium chain triglycerides (Ph Eur 0868) which are added in order to adjust the active constituent (cannabidiol) to the target content.
~Each mL of MediCabilis provides:
~50 mg of Cannabidiol (CBD+CBDA)
~Less than 2 mg tetrahydrocannabinol (THC)
~Non-active ingredient: Medium Chain Triglycerides (MCT) oil sourced from coconut"
15733375|NCT04997941|Drug|Tamoxifen Oral Product|Experimental arm will have tamoxifen 40mg and active comparator arm will have tamoxifen 20mg for 14 days.
15733376|NCT04997941|Diagnostic Test|Assessment of Ki-67|Paired biopsies (before and after tamoxifen therapy) will be required for the assessment of Ki-67.
15733377|NCT04997941|Procedure|Surgery|The surgery date should be fixed before randomization. The surgery is to be performed within 1 day after the last dose of study treatment.
15733378|NCT04997928|Other|Serum PAI-1 alpha analysis.|After all four groups of patients have given their consent for the study, a sample of 5cc blood will be obtained once for the PAI-1 analysis.
15733379|NCT04997915|Other|Observational study exploring the epidemiology and outcomes of AKI in critical COVID-19 patients admitted to the ICU|Critical COVID-19 patients admitted to the ICU
15733380|NCT04997902|Drug|Tipifarnib|Oral administration
15733381|NCT04997902|Drug|Alpelisib|Oral administration
15733382|NCT04997889|Combination Product|Artificial salivary containing cumin and ginger extract|The artificial salivary containing cumin and ginger extract will be used 2 g/time (3 times/day) into the mouth for 6 days. Then, the artificial salivary containing cumin and ginger extract will be stopped for 7-10 days. After that, the artificial salivary containing cumin and ginger extract will be used 2 g/time (3 times/day) into the mouth for 3 days.
15733383|NCT04997889|Other|Commercial artificial salivary|The commercial artificial salivary will be used 2 g/time (3 times/day) into the mouth for 6 days. Then, the commercial artificial salivary will be stopped for 7-10 days. After that, the commercial artificial salivary will be used 2 g/time (3 times/day) into the mouth for 3 days.
15733384|NCT04997876|Other|Biomarker analysis|Biomarkers from presurgical OCTs are assessed
15733385|NCT04997863|Device|Sericin hydrogel sheet impregnated with EBN extract|Sericin hydrogel sheet impregnated with EBN extract will be used as a primary dressing for preventing scar development at one-half of the STSG donor site. Then, the donor site will be covered with adhesive tape (secondary dressing). The application of primary and secondary dressings will be done once daily after shower in the morning or evening. Both dressings will be recommended to wear over the donor site for 8-12 hours per day. Patients will be advised to remove both dressings before shower to clean the donor site and the surrounding skin, and then replace them with new wound dressing sheets in the next day. The duration of the dressing application will be 6 months.
15733409|NCT04997707|Drug|Propofol Abbott|in a rate of 75-100 μg/kg/min in P group, and 25μg/kg/min in BA group
15733410|NCT04997707|Drug|Sevoflurane Inhalation Solution|in BA group will be calculated by age-adjusted end - tidal MAC as follows: for age of 18-25 years, 26-40 years and ≥40 years MAC will be 2.6%, 2.2% and 1.8% respectively then final concentration to be delivered will be 0.2% lower than calculated half MAC.
15733386|NCT04997863|Device|Placebo hydrogel sheet|Placebo hydrogel sheet will be used as a primary dressing for preventing scar development at another half of the STSG donor site. Then, the donor site will be covered with adhesive tape (secondary dressing). The application of primary and secondary dressings will be done once daily after shower in the morning or evening. Both dressings will be recommended to wear over the donor site for 8-12 hours per day. Patients will be advised to remove both dressings before shower to clean the donor site and the surrounding skin, and then replace them with new wound dressing sheets in the next day. The duration of the dressing application will be 6 months.
15733387|NCT04997850|Drug|lenvatinib + sindilimab/carrelizumab|4-6 weeks after the first TACE treatment, the resectability criteria were evaluated. If not, the next treatment cycle was carried out. The trial was terminated if the drug was stopped for more than 28 days due to adverse drug reactions or other reasons. Patients with PD after 6 cycles of sindilimab/carrelizumab treatment were terminated. The follow-up treatment was based on the principle of individualization, multidisciplinary discussion and patients' willingness.
15733388|NCT04997850|Procedure|TACE|"TACE treatment is strictly in accordance with the Chinese guidelines for clinical practice of transcatheter arterial chemoembolization (TACE) for hepatocellular carcinoma (2018 Edition).
~The patients with HCC were selected according to the inclusion criteria (referring to the conditions of the subjects). The subjects who met the inclusion criteria could enter the study after they signed the informed consent. 4-6 weeks after the first TACE treatment, the resectability criteria were evaluated. If not, the next cycle of TACE treatment was carried out. The general principle is to reduce the number of interventional treatment and extend the interval of interventional operation as far as possible under the condition of controlling the tumor and the survival of patients with tumor."
15733389|NCT04997837|Drug|PD-1 inhibitor|Nivolumab/Toripalimab 240mg solution intravenously once daily, Q2W. OR Nivolumab/Toripalimab 360mg solution intravenously once daily, Q3W; OR Pembrolizumab/Tilelizumab/Sintilimab/Carrelizumab, 200mg solution intravenously once daily, Q3W.
15733390|NCT04997837|Drug|Oxaliplatin|"CapeOx: 130 mg/m2 (body surface area) solution intravenously once-daily, followed by 20 days off.
~FOLFOX: 85 mg/m2 (body surface area) solution intravenously once-daily, followed by 13 days off."
15733391|NCT04997837|Drug|Capecitabine|CapeOx: 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.
15733392|NCT04997837|Drug|Tegafur-gimeracil-oteracil potassium|SOX: 40 - 60 mg bid orally in 14 days, followed by 7 days off
15733393|NCT04997837|Drug|5-FU|FOLFOX：2400-2800mg/m2/d continuous intravenous pumping for 48h, Q2W
15733394|NCT04997837|Radiation|Radiotherapy|1.8 Gy/Fx, 45-50.4 Gy
15733395|NCT04997837|Drug|Chemotherapy|Capecitabine 625mg/m2 bid orally with radiotherapy; ORegafur-gimeracil-oteracil potassium combination drug 40-60mg bid orally with radiotherapy
15733396|NCT04997824|Procedure|Artificial Intelligence-based atrial fibrillation catheter ablation|"Patient selection for Atrial Fibrillation Catheter Ablation(AFCA)
~AI-guided prediction for poor responder of AFCA in the outpatient clinic
~Sharing information on the AI prediction with the patient and family member
~Consideration of rate control in patients who were predicted as poor responders.
~AFCA after consent to the procedure after excluding potential poor responders
~Pulmonary vein isolation and additional treatment for non-pulmonary vein triggers
~Monitoring esophageal temperature
~Post-procedure rhythm follow-up is carried out according to the study design above."
15733397|NCT04997824|Procedure|typical atrial fibrillation catheter ablation|"Patient selection for Atrial Fibrillation Catheter Ablation(AFCA)
~Decision for AFCA based on clinical guidelines and the experience of the attending physician
~AFCA after consent to the procedure
~Pulmonary vein isolation and additional treatment for non-pulmonary vein triggers
~Monitoring esophageal temperature
~Post-procedure rhythm follow-up is carried out according to the study design above."
15733398|NCT04997811|Drug|Sodium Valproate, Bezafibrate, Medroxyprogesterone|"Sodium Valproate 200mg bd, increasing to 500mg bd after 2 weeks. Bezafibrate 200mg tds, then from Week 4 increasing fortnightly in 200mg increments to 400mg tds.
~Medroxyprogesterone 400mg bd"
15733399|NCT04997811|Drug|Danazol|Danazol 1 x 200mg capsules tds, (starting 1 x 200mg od)
15733400|NCT04997798|Drug|Trastuzumab Pyrotinib Dalpiciclib Letrozole|Neoadjuvant Study of Dalpiciclib in Combination With Letrozole and Trastuzumab plus pyrotinib in early ER+ HER2+ Breast Cancer
15733401|NCT04997785|Procedure|Ultrasound-guided Pericapsular Nerve Group (PENG) Block|PENG blocks is performed by Emergency Medicine board-certified emergency physicians (EPs) with standard training program. PENG block is performed using a spinal needle (NIPRO® 21G × 70 mm) at the level of of anterior superior iliac spine, parallel to the inguinal crease, with real-time ultrasound guidance, according to the steps published by Girón-Arango et al in 2018. The investigators use 20 ml of 1% lidocaine for nerve block because this drug has a short onset time, which is adequate to relieve pain before surgical intervention.
15733402|NCT04997772|Device|Digital Gaucher Platform|Digital platform specified for Gaucher patients.
15733403|NCT04997759|Drug|Neostigmine and Sugammadex|Compare both groups efficacy of reverse the neuromuscular blocking agent
15733404|NCT04997746|Behavioral|Multiprofessional educational interventions|Preventive educational interventions
15733405|NCT04997746|Other|Measurement of anthropometric measurements|Measurement of height (in meters), weight (in kilograms), knee height, arm circumference and calf circumference (in centimeters)
15733408|NCT04997720|Other|Training|"Each course will consist of:
~Initial evaluation
~Theoretical tutorial
~Training with exercises of increasing complexity.
~Final evaluation."
15733463|NCT04997252|Drug|Apalutamide|apalutamide as neoadjuvant therapy
15733411|NCT04997707|Diagnostic Test|transcranial motor evoked potential(Tcm|using NIM-SPINE™ SYSTEM (2005 Medtronic Sofamor Danek USA, Inc.). The stimulation used is a train-of-five square wave stimulation, 2ms inter-stimulus interval, 500 μs width and 40-220 mA intensity which can be increased with 10 mA steps till muscle answer potential is recorded.
15733412|NCT04997694|Procedure|Pre Heating|Before anesthesia was given, the participants were warmed for 20 minutes with prewarming techniques. Presence of postoperative hypothermia, vital signs and temperature comfort level were evaluated.
15733413|NCT04997681|Behavioral|Combined Aerobic Exercise and Resistance Training (AE + RT)|AE + RT will be conducted via a video-conferencing platform under the direct supervision and coaching of a certified exercise physiologist with certification from the Canadian Society for Exercise Physiology (CSEP; or equivalent certification). These certified trainers will administer the exercise interventions in a one trainer to one participant ratio. AE + RT includes a set of warm up exercises, which will be completed in approximately 5 minutes, followed by a break. Next, 6 strength training exercises (that progressively increase in resistance intensity over time) will be completed followed by a break. Aerobic exercises that safely increase the participant's heart rate will follow for 30 minutes followed by a break and a set of cool down exercises for 5 minutes. In total the AE + RT exercise session is approximately 65 minutes.
15733414|NCT04997681|Behavioral|Cognitive Training (NeuropeakTM)|NeuropeakTM is a program which will be completed by participants remotely using a tablet or computer. It consists of cognitive training including dual-task training that requires participants to maintain and prepare for many response alternatives (working memory) and to share attention between two concurrent tasks (divided attention). Difficulty of cognitive training is tailored to their individual functioning level. During each session, participants perform one of two different visuo-motor tasks, which include sets of visual stimuli (e.g., letters, numbers, animals, vehicles, fruits, celestial bodies) and respective hand-button correspondences (i.e., keys that are to be tapped on either the right or the left side of the screen). Participants are instructed to perform these tasks as fast as possible, while maintaining accuracy. Training also includes online feedback and a histogram of daily performance to encourage improvement. NeuropeakTM takes approximately 30 minutes to complete.
15733415|NCT04997681|Behavioral|Control Cognitive Training of Website Searching and Video Watching (WS+V)|During the WS + V task, participants alternate between 2 different tasks (touristic searching using internet and video watching). For the touristic searching using internet, participants are required to find 3 hotels, 3 touristic places, and 3 restaurants of their own preference in a city assigned by the instructor (a new city will be selected each session). They will also need to include the respective addresses of those places on their log sheet. For the video watching task, participants watch a National Geographic video on YouTube selected by the instructor with a different video selected for each session. They will watch the video for 20 minutes and during the remaining 5 minutes they will answer the following questions on their log sheet: 1) What is the video about? 2) What is the most important information in your opinion? 3) Create a question based on the video and answer your own question. WS + V sessions take approximately 30 minutes to complete.
15733416|NCT04997681|Behavioral|Control Balance and Toning Exercise Training (BAT)|BAT exercises will be conducted via a video-conferencing platform under the direct supervision and coaching of a certified exercise physiologist with certification from the Canadian Society for Exercise Physiology (CSEP; or equivalent certification). These certified trainers will administer the exercise interventions in a one trainer to one participant ratio. BAT includes a set of warm up exercises, which will be completed in approximately 5 minutes, followed by a break. Next, 6 balance and toning exercises will be completed followed by a break. Stretching exercises will follow for 30 minutes followed by a break and a set of cool down exercises for 5 minutes. In total the BAT exercise session is approximately 65 minutes.
15733417|NCT04997668|Procedure|Percutaneous nephrolithotomy|Patients will be undergoing surgery to remove kidney stone, and will be randomized to 1 of two standard of care methods. THe two groups are routinely FDA approved lasers - Soltive and Ho:Yag
15733418|NCT04997655|Diagnostic Test|Ultrasound measurement|In the patient group who will undergo elective laparoscopic cholecystectomy, the diaphragmatic thickness values measured and recorded routinely at the pre-operative, post-extubation and post-operative 30th minute, at the end of inspiration and expiration, and the inspiratory amplitude in m-mode in the ultrasound measured from the right anterior axillary line subcostal area were observed as observational data. will be saved in our file.
15733419|NCT04997642|Behavioral|neuropsychiatric and cognitive testing questionnaires|"Demographic data such as race, sex, age Family History Risk Factor Questionnaire Hoehn and Yahr Stage UPDRS Parkinson's symptom checklist Medication list Neuropsychological Test Battery Behavioral Exams
~Geriatric Depression Scale Quality of Life Questionnaire
~PDQ-39, SF-12"
15733420|NCT04997616|Dietary Supplement|Happy Lane Hemp Extract/CBD soft gels (25 mg/capsule)|Half of the study participants (5 women and 5 men) will be taking one gel capsule per day (25 mg/day dose), while the other half (5 women and 5 men) will be taking 2 gel capsules per day (50 mg/day dose). Study participants will be taking gel capsules for 10 consecutive days. At the end of this 10-day regimen, study participant will return to the TRI where blood specimen (up to 15 mL) will be collected within 2 to 6 hours after the last dose. Major plant cannabinoids and cannabinoid metabolites in each blood specimen will be determined using liquid chromatography-mass spectrometry.
15733421|NCT04997603|Other|Accelerometer|Fitbit brand
15733422|NCT04997590|Biological|Umbilical cord blood mononuclear cells|injection of CB-MNCs (cell count 1×108 cells/time) was performed once every 2 week for a total of 3 times.
15733423|NCT04997590|Drug|Staphylococcal Enterotoxin C|injection of staphylococcal enterotoxin C was performed once every 2 week for a total of 3 times.
15733424|NCT04997577|Behavioral|Auditory-cognitive training paradigm|The investigators developed an American English version of the Nottingham (UK) PLUS training paradigm in which listeners are asked to focus and listen to one speaker while ignoring another speaker. The paradigm is designed to optimally enhance the possibility of benefit: an adaptive procedure is employed to train each individual at their own level to make the task challenging. A short-term memory component, in which listeners are asked to remember what a designated speaker said two sentences prior, was added to the auditory training paradigm to make the task more challenging. Participants will be asked to recall the keywords of the to-be-attended speaker. The sentences will be presented in a two-down one-up adaptive procedure in which the ratio of the levels of the to-be-attended and to-be-ignored speaker will be adjusted based on the correctly recalled key words.
15745267|NCT04898673|Device|CP1000|Sound Processor
15733425|NCT04997577|Behavioral|Auditory training paradigm|The investigators developed an American English version of the Nottingham (UK) PLUS training paradigm in which listeners are asked to focus and listen to one speaker while ignoring another speaker. The paradigm is designed to optimally enhance the possibility of benefit: an adaptive procedure is employed to train each individual at their own level to make the task challenging. Participants will be asked to recall the keywords of the to-be-attended speaker. The sentences will be presented in a two-down one-up adaptive procedure in which the ratio of the levels of the to-be-attended and to-be-ignored speaker will be adjusted based on the correctly recalled key words.
15733426|NCT04997577|Behavioral|Active Control of Informational videos|Individuals are asked to watch informational videos and answer questions related to the content of the videos.
15733427|NCT04997564|Drug|Tenofovir Alafenamide 25 MG|All the patients will use prophylactically TAF for 4 weeks before using SOF/VEL once daily for 12 weeks. Group 1 patients will be discontinued TAF once daily therapy at the end of week 28 if no HBV reactivation occurs during treatment .
15733428|NCT04997564|Drug|Sofosbuvir / Velpatasvir|All the patients will use prophylactically TAF for 4 weeks before using SOF/VEL once daily for 12 weeks. Group 2 patients will be received TAF once daily for 64 weeks. In this study, after week 64.
15733429|NCT04997551|Drug|Colchcine|"In patients not taking lopinavir / ritonavir or any other CYP3A4 or P-glycoprotein inhibitor drugs:
~Day 1: 1 single dose of 1 mg orally, in a single dose.
~Days 2 to 6: 0.5 mg every 12 hours v.o.
~Days 7 to 14: 0.5 mg / 24 hours v.o. In patients taking drugs that inhibit the CYP3A4 system or the P-glycoprotein, these drugs will be attempted to be discontinued. The dose in these cases will be: o 0.5 mg every 72 hours v.o. while taking the drug that interacts.
~or 0.5 mg every 24 hours v.o. when, after suspending the interacting drug, at least 5 half-lives of the suspended drug have elapsed, from the last intake of said drug (in the case of lopinavir / ritonavir this would be a total of 24-30 hours) until the 14th day.
~In patients older than 80 years or patients with CKD-EPI estimated glomerular renal failure filtration rate between 30 and 50 ml / min / 1.73 m2), the colchicine / placebo dose will be:
~o Days 1 to 14: 0.5 mg / day"
15733430|NCT04997525|Drug|Estradiol Tablets|Combined with progesterone
15733431|NCT04997525|Drug|Progesterone|Combined with estradiol
15733432|NCT04997525|Drug|Follitropin Alfa|Combined with hCG
15733433|NCT04997525|Drug|Chorionic Gonadotropin, Alpha|In etiher natural cycle or combined with Follitropin Alfa
15733434|NCT04997512|Device|Freestyle libre|A glucose sensor (flash) which measures interstitial blood glucose every 15 minutes or on demand.
15733435|NCT04997512|Other|Nurse led structured intervention - hypoglycaemia education and diabetes treatment modification modification|An education programme surrounding avoidance of hypoglycaemia at baseline. Regular review (weeks 2, 4, 12 and 24) and adjustment of diabetes medications based on freestyle libre data.
15733436|NCT04997499|Behavioral|watch an instructional video|watch instructional video and then perform self injection of subcutaneous depot-medroxyprogesterone based on the video teaching
15733437|NCT04997486|Behavioral|Time restricted eating|Participants will be asked consume all meals/snacks during a ~9-h daily eating period (~15-h fasting).
15733438|NCT04997473|Behavioral|W8L2G mobile health (mHealth) app|Weight loss phone app based on addiction principles. This intervention has been validated in two prior studies. Participants will also interact with coaches throughout the intervention
15733439|NCT04997447|Behavioral|Step-reduction/Exercise Rehab|2-week limited daily steps (<2000), and then 4 weeks of typical strength+endurance exercise for older adults
15733440|NCT04997434|Behavioral|Art-therapy in the emergency department|"The intervention will begin with a 5-10 minute interview with the patient to define his or her tastes and contraindications to certain techniques. Since the art-therapeutic intervention that will be proposed seeks to generate pleasant feelings, it will be important to rely on the patient's tastes. At the end of the interview, modern art therapy will be presented to the patient and several artistic activities will be proposed (origami, drawing, creative writing).
~Once the activity has been chosen, the patient will have 15 to 20 minutes to carry it out, accompanied by the art therapist according to his/her needs. During the activity, verbal exchanges will continue. After the 15 to 20 minutes of the session, 5 minutes will be devoted to the patient's self-evaluation of the past moment, of his level of anxiety, of the intensity of his pain and of his feelings in relation to his passage in the Emergency Department and the art therapy session."
15733441|NCT04997421|Device|Combined HA380 hemoadsorption and continuous veno-venous hemodiafiltration (CVVHDF) with Oxiris®-AN69 membranes|Combined HA380 hemoadsorption and continuous veno-venous hemodiafiltration (CVVHDF) with Oxiris®-AN69 membranes (intervention arm)or mere CVVHDF using the Oxiris®-AN69 membrane (control arm).
15733442|NCT04997421|Device|Continuous veno-venous hemodiafiltration (CVVHDF) with Oxiris®-AN69 membranes|Continuous veno-venous hemodiafiltration (CVVHDF) with Oxiris®-AN69 membranes (control arm)
15733443|NCT04997408|Device|Customized exercise app|A Wearable Device-Based Assisted Post-Stroke Rehabilitation system
15733444|NCT04997408|Other|In-person therapist-supervised rehabilitation|In-person therapist-supervised rehabilitation
15733445|NCT04997395|Drug|Full spectrum cannabidiol dominant medicinal cannabis|Full spectrum cannabidiol dominant medicinal cannabis
15733446|NCT04997382|Drug|Alectinib|Alectinib Cap 600 mg po bid
15733448|NCT04997356|Behavioral|Hostile Bias Modification Training|Volunteers will complete a novel computer-based hostile bias modification training where they are instructed to respond to word fragments (words with missing letters) based on whether the word fragments can be completed to form aggressive or positive/neutral words. They will refrain from making words that can only form aggressive words.
15733449|NCT04997356|Behavioral|Other training|Volunteers will complete a computer-based task where they are instructed to respond to word fragments (words with missing letters) regardless of whether the fragments can make hostile or ambiguous words.
15733599|NCT04996173|Device|Spray cryotherapy|A novel FDA cleared technique that allows for Liquid nitrogen (LN2) to be delivered in a metered fashion via a catheter through a flexible bronchoscope.
15733450|NCT04997343|Other|Neurophysiological assessment|EMG will be recorded from the Abductor pollicis brevis muscle (APB) with surface electrodes. EEG will be recorded with a 32-channel elastic cap via a TMS compatible system. TMS will be performed using a Magstim 200 stimulator with a 90 mm figure-of-eight coil localized on motor and non-motor areas using a neuronavigation system together with an optical tracking system. Coordinates for neuronavigation will be calculated in the MNI space and fit of each participant's anatomical MRI. Three minutes of continuous-EEG will be recorded with subjects at rest. Single-pulse neuronavigated TMS (sp-TMS) will be delivered at rest below the resting motor threshold intensity (RMT) over the APB hotspot on M1 during concurrent EEG recording. In a final block, the subject will maintain a voluntary muscle contraction (50% of the maximal voluntary contraction) of the left APB, and sp-TMS will be delivered at 130% RMT over the ipsilateral APB hotspot in order to record the lpSP.
15733451|NCT04997343|Other|clinical assessment|"Clinical evaluation, performed at each time point, will include:
~The assessment of clinical disability using EDSS score
~The multiple sclerosis functional composite (MSFC), a three-part quantitative objective measure of neurologic function, measuring lower limbs (timed 25-foot walk [T25FW]), upper limbs (nine-hole peg test [9HPT]) and cognitive (three-second paced auditory serial addition test [PASAT3]) function.
~In order to reduce inter-rater variability, the same physician/technician with adequate training will administer all three tests. The patient should feel comfortable with the situation. Examiner should explain the instructions in a professional but friendly way and let the patient ask any questions before starting the tests. Examiner should write down the test results, as well as any situation that disturbs the performance of patient. Examiner should not provide direct feedback to the patient about his/her performance"
15733452|NCT04997330|Device|Active rTMS|Bilateral high frequency (20Hz) rTMS will be delivered (over dorsolateral prefrontal cortex), at two daily sessions (left side on the morning and right side on the afternoon), 10 consecutive days on working day, 1500 pulses/session, 110% of motor threshold determined, 30 trains, 50 pulses per train and 15s inter train. A session will typically last around 10 minutes. Alcohol cues consisted of a selection of 60 alcohol-related pictures (beverage, drinking-related behaviors, alcohol-related cues) from the Geneva Appetitive alcohol Pictures will be presented during each rTMS session.
15733453|NCT04997330|Device|Sham rTMS|Sham rTMS will be delivered (over dorsolateral prefrontal cortex) , at two daily sessions (left side on the morning and right side on the afternoon), 10 consecutive working days. A session will typically last around 10 minutes. Alcohol cues consisted of a selection of 60 alcohol-related pictures (beverage, drinking-related behaviors, alcohol-related cues) from the Geneva Appetitive alcohol Pictures will be presented during each rTMS session.
15733454|NCT04997317|Drug|177Lu-DOTA-JR11 (Phase 0); Cycle 1 and Cycle 2 (cross-over)|177Lu-DOTA-JR11 has three main components, namely the somatostatin analogue JR11, the chemical chelator group DOTA and the beta emitter 177Lutetium (177Lu). In the Phase 0 part of the study 177Lu-DOTA-JR11 will be administered once intravenously. The activity of the first 2 cycles will be capped at 4.5 GBq (range: 4.2-4.6 GBq).
15733455|NCT04997317|Drug|177Lu-DOTATOC (Phase 0); Cycle 1 and Cycle 2 (cross-over), Cycle 3 and 4|177Lu-DOTATOC is a therapeutic medicinal product and has 3 main components (a) 177Lutetium (177Lu), a beta-emitting radionuclide with a half-life of 6.64 days; (b) DOTA, a chemical chelator group; and (c) TOC (= [Tyr]3-octreotide) an agonistic somatostatin analogue which binds to sstr2 and sstr5 receptors. In the Phase 0 part of the study 177Lu-DOTATOC will be administered once intravenously. The activity of the first 2 cycles will be capped at 4.5 GBq (range: 4.2-4.6 GBq). The remaining 2 cycles will be performed with an activity of 7.4 GBq 177Lu-DOTATOC (total number of cycles = 4).
15733456|NCT04997317|Drug|177Lu-DOTA-JR11 (Phase I/II)|In the phase I/II part of the study: 3 cycles of 177Lu-DOTA-JR11 will be administered with an activity of 4.5-7.4 GBq. Two additional 177Lu-DOTA-JR11 treatment cycles can be performed if clinically indicated
15733457|NCT04997304|Combination Product|AirDuo Digihaler|"Patients will receive the AirDuo® Digihaler™ at a dose that is equivalent to the patients current inhaled therapy dose. Most patients will likely require the high dose inhaler: 232/14 device. This medication will be administered twice daily. The study and treatment will last 1 year.
~Participants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis."
15733458|NCT04997304|Combination Product|ProAir Digihaler|Patients will receive the ProAir® Digihaler™ 90mcg at a dose that is equivalent to the patients current inhaled therapy dose. Most patients will likely require the high dose inhaler: 232/14 device. The ProAir® Digihaler™ will be utilized up to six times per day as needed for acute asthma symptoms. The study and treatment will last 1 year.
15733459|NCT04997291|Drug|Dexrazoxane|Twelve enrollees will be consecutively assigned to a dosing regimen of 400 mg/m2/dose. The medication will be administered in the operating room 30 minutes prior to starting cardiopulmonary bypass (dose #1), prior to aortic cross clamp removal (dose #2), and on the morning after surgery in the cardiac intensive care unit (dose #3).
15733460|NCT04997278|Device|Coordinated Reset spinal cord stimulation|"Abnormal neuronal synchrony in terms of enhanced 4-9 Hz theta oscillations in EEG/MEG recordings appears to be an important pathophysiological finding in patients with neurogenic pain. To specifically counteract abnormal neuronal synchrony, we here set out to perform Coordinated Reset (CR)-Spinal Cord Stimulation (SCS). CR stimulation (Tass, 2003) aims at an anti-kindling, i.e. an unlearning or resetting of abnormal neuronal synchrony and abnormal synaptic connectivity, and, hence, long-lasting, sustained therapeutic effects that persist following cessation of stimulation (Tass & Majtanik, 2006)."
15733461|NCT04997265|Other|Low intensity anticoagulation|Participants assigned to the low intensity anticoagulation strategy will receive anticoagulation at doses used for DVT prophylaxis in critically ill patients. The choice of agent (e.g. heparin or enoxaparin) and specific dosing will be at the discretion of the treating clinicians and will be prospectively recorded.
15733462|NCT04997265|Other|Moderate Intensity Anticoagulation|"Patients assigned to the moderate intensity anticoagulation strategy will receive anticoagulation targeting a PTT goal of 40-60 seconds or anti-Xa level of 0.2 to 0.3 IU/mL. Choice of anticoagulant and monitoring strategy (PTT or anti-Xa level) will be at the discretion of the treating clinicians and will be prospectively recorded. Anticoagulant drips will be titrated according to institutional protocols. For patients who survive to decannulation, the infusion will be stopped one hour prior to decannulation.
~This approach to anticoagulation reflects the current approach for patients receiving V-V ECMO at Vanderbilt University Medical Center and is similar to protocols widely adopted for patients receiving V-V ECMO at other centers."
15733466|NCT04997226|Device|tDCS or tACS over the left DLPFC with adaptive memory game|This intervention is described in arms 1 and 3.
15733467|NCT04997226|Device|Sham tDCS or tACS over the left DLPFC with adaptive memory game|This intervention is described in arms 2 and 4.
15733468|NCT04997213|Other|Biofeedback exercises|Biofeedback system is a center of pressure-controlled video game-based exercise system designed for patients with neurological and orthopedic diseases and provides balance training using auditory, visual, and pressure biofeedback. The system contains several games, each designed to focus on a different component of balance. Biofeedback is provided by means of a monitor in front of the patient. The balance exercises program was involved a total of 18 sessions, each lasting 20 min, three times a week for six weeks, and was individually tailored based on the patient's tolerance and current motor and sensorial capacities. All patients performed conventional exercises.
15733469|NCT04997213|Other|Conventional Exercises|Classic balance exercises were performed (two-leg stance, semi-tandem stance, tandem stance, standing on one leg, tandem walking, turning completely around, heel-to-toe stance, and standing with the eyes closed). Patients with balance disorder first could be commenced balance training in a seated position before progressing to standing exercises, to the extent that these could be tolerable.
15733470|NCT04997200|Behavioral|One night's sleeplessness|A night without sleep. No daytime sleeping the day before the test. Participants are observed by staff at the trial unit during the night before the test.
15733474|NCT04997161|Drug|Sodium Zirconium Cyclosilicate (SZC)|Participants in the active arm will receive SZC dosed as per the local label to control hyperkalaemia and maintain normokalaemia.
15733475|NCT04997161|Other|Enhanced dietary advice|Participants will receive enhanced dietary advice in addition to taking SZC. This will include advice from dietitians to consume fruit and vegetables. Participants will be encouraged to consume up to 70 mmol K+ per day.
15733476|NCT04997161|Other|Standard dietary advice including K+ restriction.|Participants randomised to the SoC arm of the Diet Comparison Phase will receive standard dietary advice including K+ restriction.
15733477|NCT04997122|Other|Olive pomace oil|Volunteers consumed during 4 weeks 45 g/d of olive pomace oil as the only source of dietary fat, used for cooking, salad dressing, toasts, etc.
15733478|NCT04997122|Other|High oleic acid sunflower oil|Volunteers consumed during 4 weeks 45 g/d of oleic acid-rich sunflower oil as the only source of dietary fat, used for cooking, salad dressing, toasts, etc.
15733479|NCT04997109|Other|APPLES-tele|"The APPLES-tele intervention is 5 weekly telehealth sessions of therapist-demonstrated tasks, delivered over a 6 week period. Infant participants wear a soft-constraint harness (C-Mitt) on their less affected arm for 6 hours per day, while their parent encourages them to use their more affected arm to reach for objects with a sticky-mitt. As the infant experiences success, heavier objects are provided. During times when the C-Mitt is not worn, parents engage therapist-demonstrated bimanual play of increasing difficulty."
15733480|NCT04997109|Behavioral|Parent-centered Approach (PCA) Support Intervention|The PCA support intervention is 5 weekly telehealth sessions delivered over a 6 week period. The PCA curriculum includes 5 basic principles of positive parenting from Triple P: ensuring a safe engaging environment, creating a positive learning environment, using assertive discipline, having reasonable expectations, and looking after yourself as a parent. All of these elements, when taught to parents in an individualized manner, can help promote responsivity, structure and expectations that are tailored to their child's condition and developmental stage. In addition, a curriculum of CP-specific knowledge will address the challenges unique to parents of children with CP, such as understanding principles of infant learning of new movements, challenges and solutions for self-directed activity in infants with CP.
15733481|NCT04997109|Behavioral|Standard of Care|Participants receiving the usual care from being followed in high-risk infant follow-up (HRIF) programs in the Early Detection and Intervention (EDI) Network. This includes referrals for state early intervention services, therapy and specialty screening for co-morbidities, and access to psychologists to help parents adjust to the new diagnosis of cerebral palsy.
15733482|NCT04997096|Other|Exercise|16-week, virtually supervised, technology-based, aerobic and resistance exercise program performed 3 days per week which starts at least 4 weeks after surgery
15733483|NCT04997096|Other|Attention Control|Home-based stretching program consisting of one set of 4 static stretching exercises held for 30 seconds and performed 3 days/week. Participants will be shown how to use the booklet and instructed on how to complete the stretching exercises by an exercise trainer.
15733484|NCT04997083|Device|Maxillary Expander with Differential Opening (EDO)|The EDO is designed with two expansion screws positioned transversely. When more expansion is required between the canines, the anterior screw can be further activated. Both expansion screws can be activated to open in a parallel configuration. Pivoting corner screws allow for different amounts of expansion without significant risk of binding during activation.
15733485|NCT04997083|Device|Petit face mask|The face mask is anatomical, multi-adjustable, lightweight and an ideal therapeutic alternative for the correction of Class III malocclusion. It consists of forehead cap, chin cap, and cross bar.
15733486|NCT04997057|Dietary Supplement|Probiotics mixture|"12 weeks of daily supplementation with 1 g of probiotics mixture (4.10exp9 colony forming unit/g) containing:
~Bifidobacterium longum LA 101
~Lactobacillus helveticus La 102
~Lactococcus lactis LA 103
~Streptococcus thermophilus LA 104"
15733514|NCT04996771|Drug|Surufatinib,Etoposide,Cisplatin,Toripalimab|"In dose escalation, Surufatinib and will be administered orally (PO) once daily (QD) ,d1-21，q3w+Toripalimab 240mg,d1,q3w+Etoposide 100mg/m2,d1-3,q3w+Cisplatin 75mg/m2 , d1, q3w,4 cycles in total.
~At the indication-specific expansion portion of the study, patients will receive surufatinib RP2D,d1-21，q3w+Toripalimab 240mg,d1,q3w+Etoposide 100mg/m2,d1-3,q3w+Cisplatin 75mg/m2 , d1, q3w,4 cycles in total. After the end of the first-line treatment, patients with CR, PR, and SD can continue to maintenance treatment with Surufatinib RP2D,d1-21，q3w＋Toripalimab 240mg,d1,q3w was taken orally until the disease progressed."
15733490|NCT04997018|Radiation|Radiation Therapy|"Patients enrolled in this study will undergo ultra-hypofractionated radiation utilizing MR guided, daily online adaptive planning. Patients will receive a standard dose of 8 Gy/fraction for five fractions for a total dose of 40 Gy to the prostate with a simultaneously-delivered boost of 9 Gy for five fractions (clinically non-standard dose of 45 Gy total) to a single dominant lesion with a maximum dimension of at least 0.5 cm, as determined on the pretreatment diagnostic T2 MRI imaging. In the setting of two similarly-sized dominant lesions, both will be boosted."
15733491|NCT04997005|Device|AMIStem-P|Performance of Total Hip Arthroplasty (THA) with AMIStem-P femoral stem implant
15733492|NCT04996992|Procedure|MR-guided focused ultrasound|MR-guided focused ultrasound pallidothalamic tractotomy is a minimally invasive and effective procedure for thetreatment of Parkinson's disease(PD) patients.
15733493|NCT04996979|Drug|Ropivacaine 0.5% Injectable Solution|Local anaesthetic solution composed of ropivacaine 0.5%(intervention group)
15733494|NCT04996979|Drug|Placebo|Standard care
15733495|NCT04996966|Biological|human umbilical cord-derived mesenchymal stem cells|In the MSCs injection group, 1×10^6/kg human umbilical cord-derived mesenchymal stem cells were intravenously injected to the patient immediately after the surgery and at day 3 after the surgery.
15733496|NCT04996966|Other|saline|In the control group, saline containing 2% albumin (2ml/kg) were intravenously injected to the patient immediately after the surgery and at day 3 after the surgery.
15733497|NCT04996940|Device|E-cigarette product|Participants will then be randomized 1:1 to e-cigarette flavor order (tobacco e-cigarette, menthol e-cigarette). They will complete a 30-minute ad libitum session with each flavor, based on randomization. Throughout each session, puff topography will be measured via a pressure sensor attached to the e-cigarette device.
15733498|NCT04996914|Procedure|TACE|1-2 session TACE before SBRT according to the preference of the interventional radiologist. Goal of TACE is the complete emnbolization of the HCC-nodules. It is allowed to use both conventional TACE (cTACE) and drug-eluting beads TACE (DEB-TACE) according to the interventional radiologist preference.
15733499|NCT04996914|Radiation|SBRT|"SBRT should be 1 month after last TACE. This can be extended till 2 months if indicated. However, prolongation of the gap between TACE and SBRT is not encouraged.
~Treatment center should choose one of fractionation schedule mentioned allowed in the study, in order to achieve a balance between dose applied for tumor control and constraints for OAR PTV Dose in 5 / 8 fractions (Gy) BED (α/β 10Gy) 5x 10 Gy @ 83% isodose = 50 Gy (100 Gy) 8 x 7.5 Gy @ 83% isodose = 60 Gy (105 Gy)"
15733500|NCT04996901|Other|no intervention|no intervention
15733501|NCT04996888|Device|AI based preoperative automatic reminder system|the patients in the experimental group will be sent a message and a phone call by AI system on the day before colonoscopy, which will emphasize the importance of bowel preparation, the directions for use and side effects of purgatives, the proper food type, and the start time. The system is an non-invasive AI system.
15733502|NCT04996875|Drug|CGT9486 tablets|CGT9486 is supplied as tablets to be taken orally, continuously in 28-day cycles.
15733503|NCT04996849|Other|Data Capture|Data collected
15733504|NCT04996849|Other|Questionnaire Administration|Ancillary studies
15733505|NCT04996836|Biological|Next Generation Sequencing and Network Analysis|Next Generation Sequencing and Network Analysis will profile genetic and epigenetic abnormalities in blood from patients with BC.
15733506|NCT04996823|Drug|Ipilimumab|Participants will receive ipilimumab 3mg/kg IV every 3 weeks for up to 4 doses.
15733507|NCT04996823|Drug|Axitinib|Participants will take 5 mg Axitinib twice daily by mouth for up to 35 cycles (24 months)
15733508|NCT04996810|Biological|PROTOXIN|Botulinum toxin Type A
15733509|NCT04996810|Biological|Botox®|Botulinum toxin Type A
15733510|NCT04996797|Drug|PRA023 IV|PRA023 administered by IV infusion
15733511|NCT04996797|Device|Companion Diagnostic (CDx) Testing|PRA023 CDx Genotyping Assay
15733512|NCT04996797|Other|Placebo|Placebo administered by IV infusion
15733513|NCT04996784|Other|Capillary blood sampling|The capillary blood sample will be obtained by pricking the fingertip using contact-activated lancet (BD Microtainer). A total of five blood drops (10 μL each) will be collected by a micropipette and will be dropped off on the blotting paper 903 S&S (Whatman).
15733596|NCT04996199|Drug|Oxcarbazepine|oxcarbazepine 150mg BD initial dose , followup will be done at 15days, 6weeks, 10 weeks interval
15733515|NCT04996771|Drug|Surufatinib,Etoposide,Cisplatin|"In dose escalation, Surufatinib and will be administered orally (PO) once daily (QD) ,d1-21，q3w+Etoposide 100mg/m2,d1-3,q3w+Cisplatin 75mg/m2 , d1, q3w,4 cycles in total.
~At the indication-specific expansion portion of the study, patients will receive surufatinib RP2D,d1-21，q3w+Etoposide 100mg/m2,d1-3,q3w+Cisplatin 75mg/m2 , d1, q3w,4 cycles in total. After the end of the first-line treatment, patients with CR, PR, and SD can continue to maintenance treatment with Surufatinib RP2D,d1-21，q3w was taken orally until the disease progressed."
15733516|NCT04996758|Drug|Toripalimab and Anlotinib|Toripalimab 240 mg iv.drip d1; Anlotinib 12mg po qd d1-14.
15733517|NCT04996745|Behavioral|Tablet-based educational intervention|"POSNA's Orthokids website and the article on pediatric forearm fracture will be provided on a tablet. The article provided has two separate tabs, labeled Condition and FAQs, that caregivers will be able to read through. Those who speak Spanish will have the Spanish translated version of Orthokids."
15733518|NCT04996732|Procedure|hospitalization|Including various treatments such as surgery, radiotherapy, chemotherapy and immunotherapy during hospitalization
15733520|NCT04996693|Diagnostic Test|Imaging on Scanner with Spectral Imaging Capabilities|Patients will undergo imaging on a modern CT scanner with spectral imaging capabilities. A dose neutral spectral acquisition mode will routinely be used. Contrast material protocol and scan ranges are similar in all three arms.
15733521|NCT04996693|Diagnostic Test|CT Scan using an Energy-Integrating Detector CT (128 slice MDCT)|Patients will undergo imaging on a modern 128-slice CT scanner (Siemens Healthineers) with energy-integrating detector and without spectral acquisition mode. Contrast material protocol and scan ranges are similar in all three arms.
15733522|NCT04996693|Diagnostic Test|CT Scan using an Energy-Integrating Detector CT (20-slice MDCT)|Patients will undergo imaging on a modern 20-slice CT scanner (Siemens Healthineers) with energy-integrating detector and without spectral acquisition mode. Contrast material protocol and scan ranges are similar in all three arms.
15733523|NCT04996680|Device|Blood Flow Restriction (by using smart-cuff pro devices, acting as pressurized tourniquet) combined low load strengh training|This group will undergo standard, traditional low load strength training consisting of calf, thigh, glute and core exercises, combined with optimal pressurized blood flow restriction
15733524|NCT04996680|Other|Standardised low load strength training|This group will undergo standard, traditional low load strength training consisting of calf, thigh, glute and core exercises
15733525|NCT04996680|Device|Sham-BFR (by using smart-cuff pro devices, acting as pressurized tourniquet) combined with low load strength training|This group will undergo standard, traditional low load strength training consisting of calf, thigh, glute and core exercises, combined with blood flow restriction, but pressurized so the occlusion cuff has no significant effect on the lower limb blood flow.
15733526|NCT04996667|Drug|inhaled nitric oxide (iNO)|"Inhaled nitric oxide (iNO), which is known mainly from the pulmonary hypertension literature for its therapeutic role in pulmonary arterial hypertension, has been proposed as a potential pharmacologic adjunct to standard anticoagulation in acute PE.
~Inhaled nitric oxide (iNO) will be administered at 30 ppm for 3 minutes. The measurements will be obtained/calculated before, during iNO administration, and after iNO has been withheld for 2 minutes."
15733527|NCT04996654|Behavioral|Exergame|According to the training concept, each participant is instructed to train 5x/week for 21 min per session resulting in a weekly exercise volume of 105 min. All training sessions are planned to take place at participant's homes using the exergame training system Dividat Senso (Dividat AG, Schindellegi, Switzerland; CE certification).
15733528|NCT04996654|Behavioral|Usual Care|An active control group will proceed with usual care as provided by the memory clinics where the patients are recruited.
15733530|NCT04996628|Diagnostic Test|Quantitative Sensory Test 1|Subject will give pain rating (on Visual Analogue Scale (VAS) 0-10) of single as well as multiple stimulation with round-tip non-invasive pin-prick device. Difference is recorded as Temporal Summation Score.
15733531|NCT04996628|Diagnostic Test|Quantitative Sensory Test 2|Subject will state when they first detect pain and pain detection threshold in response to pressure administration with pressure algometer. Pressure threshold recorded in kilopascals(kP). Stimulation will be repeated in pancreatic and control dermatomes. Subject will then state pain tolerance threshold at same locations. Sensitization will be characterized by ratio of pancreatic vs. control dermatome scores.
15733532|NCT04996628|Diagnostic Test|Quantitative Sensory Test 3|Subject will apply dominant hand to ice-chilled water bath (36F) for up to 2 minutes. Pain score (VAS 0-10) will be assessed each 10 seconds. Pain tolerance threshold (in kP) will be assessed with algometer on non-dominant thigh before and after water bath to determine change in threshold. Difference in pain tolerance recorded as Conditioned Pain Modulation Score.
15733533|NCT04996615|Other|no intervention|no intervention
15733534|NCT04996602|Drug|1.85GBq of 177Lu-EB-PSMA-617|Patients were intravenous injected with the dose about 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles.
15733535|NCT04996602|Drug|7.40GBq of 177Lu-PSMA-617|Patients were intravenous injected with the dose about 7.40GBq (200 mCi) of 177Lu-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles.
15733536|NCT04996576|Procedure|infrazygomatic approach sphinopalatine ganglion block|"A lateral fluoroscopic view of the face will be obtained with the C-arm by superimposing the mandibular rami on top of each other spinal needle with a slightly bent tip is inserted with lateral fluoroscopic guidance. superiorly and medially toward the sphinopalatine fossa.
~(AP) view intermittently obtained to check the depth 0.2 mL of contrast material will be injected to rule out intravascular spread and confirm spread of the dye within the sphinopalatine fossa .Local anesthetic, such as 2 mL of 1% lidocaine will be slowly injected"
15733537|NCT04996576|Procedure|intranasal injection approach of sphinopalatine ganglion block|method 2 ml Lidocaine with Epinephrine 1/200000 will be injected posterior to meatus of middle concha to block terminal nerve branches of sphinopalatine ganglia
15747695|NCT04878536|Dietary Supplement|Blank|Placebo drink
15733538|NCT04996563|Other|Video|A brief educational video, approximately 9 minutes in duration, on pelvic organ prolapse is sent electronically to patients to view prior to their initial visit in order to provide early access to information. The video was created to educate patients on the following key components of prolapse: the clinical condition, associated symptoms, common risk factors, evaluation and diagnosis, non-surgical treatment options, and surgical treatment options. Simple drawings and animations are included as visual aids to enhance the ability to conceptualize prolapse and its management options.
15733539|NCT04996550|Drug|Carvedilol|To compare the efficacy of carvedilol and metoprolol succinate on all-cause mortality or first hospitalization for worsening heart failure in patients with heart failure with reduced ejection fraction with an indication for treatment with beta-blockers.
15733540|NCT04996550|Drug|Metoprolol Succinate|To compare the efficacy of carvedilol and metoprolol succinate on all-cause mortality or first hospitalization for worsening heart failure in patients with heart failure with reduced ejection fraction with an indication for treatment with beta-blockers.
15733541|NCT04996537|Other|Micro-video digiral learning|On the digital platform, you can accept courses anytime, anywhere, and repeat learning, answering, leaving messages, or interacting with lecturers.
15733542|NCT04996524|Drug|epidural analgesia|Patients recieving epidural analgesia instead of systemic analgesia for acute pain in the intensive care unit
15733543|NCT04996511|Device|PulseOn|Postoperative HRV measurement
15733544|NCT04996498|Drug|Oxytocin|intrauterine Instillation of oxytocin in distention media used during Hysteroscopic Myomectomy
15733545|NCT04996498|Other|sterile bacteriostatic water ampule|a placebo drug similar in shape to oxytocin ampules
15733546|NCT04996485|Drug|Secukinumab Injection|Pathogenetic therapy with biologic drugs
15733547|NCT04996485|Drug|Ustekinumab Injection|Pathogenetic therapy with biologic drugs
15733548|NCT04996485|Drug|Dupilumab Injection|Pathogenetic therapy with biologic drugs
15733549|NCT04996485|Other|Symptomatic therapy|Active external agents, Emollients, systemic retinoids if needed
15733550|NCT04996472|Behavioral|Sensitivity to phonological rules: Adults|Assess whether adults are sensitive to different phonological patterns that are predicted to align with development of morphosyntax or the lexicon.
15733551|NCT04996472|Behavioral|Sensitivity to semantic category cues: Adults|Assess whether adults show improved learning of OR or family resemblance rules when a semantic category cue is used.
15733552|NCT04996459|Drug|Tislelizumab|Tislelizumab 200mg iv q3w
15733553|NCT04996446|Drug|Tislelizumab|In experimental group, patients who meet the inclusion criteria will receive ALPPS stage I surgery, treated with Tislelizumab 2-4 weeks after stage I surgery, and receive ALPPS stage II surgery 2-4 weeks after Tislelizumab treatment, and treated with Tislelizumab q3W 6-12 months after stage II surgery.
15733554|NCT04996446|Procedure|ALPPS surgery|In experimental group, patients who meet the inclusion criteria will receive ALPPS stage I surgery, and receive ALPPS stage II surgery 4-8 weeks after stage I surgery; In control group, patients who meet the inclusion criteria will receive ALPPS stage I surgery, and receive ALPPS stage II surgery 3-6 weeks after stage I surgery.
15733555|NCT04996433|Behavioral|inpatient CBASP individual therapy|During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 2 individual CBASP therapy sessions (duration: 50 min per session).
15733556|NCT04996433|Behavioral|inpatient CBASP group therapy|During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 2 CBASP group therapy sessions (duration: 100 min per session).
15733557|NCT04996433|Behavioral|inpatient CBASP nurse contact|During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 1 CBASP nurse contact (duration: 30 min per session).
15733558|NCT04996433|Behavioral|inpatient CBASP exercise therapy|During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 1 CBASP exercise therapy (duration: 75 min per session).
15733559|NCT04996433|Behavioral|outpatient CBASP group therapy|During the 6-week outpatient treatment all patients in this arm will receive 1 CBASP group therapy session (duration: 100 min per session).
15733560|NCT04996433|Behavioral|inpatient BA individual therapy|During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 2 individual BA therapy sessions (duration: 50 min per session).
15733561|NCT04996433|Behavioral|inpatient BA group therapy|During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 2 BA group therapy sessions (duration: 100 min per session).
15733562|NCT04996433|Behavioral|inpatient BA nurse contact|During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 1 BA nurse contact (duration: 30 min per session)
15733563|NCT04996433|Behavioral|inpatient BA exercise therapy|During the 5-week inpatient phase I and the 5-week inpatient phase II / dayclinic treatment all patients in this arm will receive 1 BA exercise therapy (duration: 75 min per session).
15733564|NCT04996433|Behavioral|outpatient BA group therapy|During the 6-week outpatient treatment all patients in this arm will receive 1 BA group therapy session (duration: 100 min per session).
15733565|NCT04996433|Drug|algorithm-based study medication|"All patients will receive an optimized, algorithm-based antidepressant medication following the current S3-Guidelines on Unipolar Depression. In case of nonresponse:
~1st line dose escalation (if appropriate)
~2nd line lithium augmentation
~3rd line augmentation with 2nd generation antipsychotics or evidence-based combinations of antidepressants
~4th line change of antidepressant."
15733566|NCT04996420|Device|Clearsight non invasive hemodynamic monitoring|Goal directed fluid therapy fuided by Clearsight monitoring
15733567|NCT04996407|Device|survival thermal blanket|patients were given a thermal blanket
15733568|NCT04996407|Device|draping fabric|Patients were given a draping fabric
15733569|NCT04996381|Diagnostic Test|Scanning Chest X-rays and performing AI algorithms on images|Chest X-Rays; AI CNNs; Results
15733570|NCT04996368|Drug|Tranexamic acid injection|Randomized comparison of two doses of tranexamic acid as prophylactic before start of incision in open heart surgery use for prevention of bleeding.
15733597|NCT04996199|Drug|Carbamazepine|carbamazepine 100mg BD initial dose, follow up will be done 2weeks, 6 weeks & 10weeks
15733571|NCT04996355|Other|comprehensive treatment after MDT discussion|"The comprehensive treatment plan was determined through MDT discussion, which was completed by the Department of Gastrointestinal Surgery, Peking University People's Hospital.
~The following regimens will be tested with organoids-on-a-chip：
~5-FU
~Oxaliplatin
~Irinotecan
~5-FU+ Oxaliplatin
~5-FU+ Irinotecan
~5-FU+ Oxaliplatin+ Irinotecan
~5-FU+Cetuximab
~Cetuximab
~Regorafenib"
15733572|NCT04996329|Other|early health warning intervention|early health warning intervention is to tell the subjects that smoking leads to the rapid decline of their lung function, and they are at the high risk of developing COPD.
15733573|NCT04996316|Other|Electronic Health Record Review|Health record reviewed
15733574|NCT04996316|Other|Interview|Participate in interview
15733575|NCT04996316|Other|Media Intervention|Use MammoScreen
15733576|NCT04996316|Other|Survey Administration|Complete survey
15733577|NCT04996316|Other|Training and Education|Undergo training
15733578|NCT04996303|Drug|Routine steroid administration group|Steroid administration with routine dose - Methylprednisolone 1 mg/kg 7 days → 0.5 mg/kg 7 days → 0.25 mg kg 7 days
15733579|NCT04996303|Device|Steroid pulse therapy group|Steroid administration with pulse dose - Methylprednisolone 10 mg/Kg (500 mg ~ 1g) pulse 3 days -> Methylprednisolone 1 mg/kg 7 days → 0.5 mg/kg 7 days → 0.25 mg/kg 7 days
15733580|NCT04996290|Procedure|PENG + LFCN block|Regional anesthesia technique
15733581|NCT04996290|Drug|Ropivacaine injection|Local anesthetic used for peripheral nerve block.
15733582|NCT04996277|Procedure|angiography|All STEMI patients will be treated according to the hospital's standard procedures and the plaque will be monitored for 7-30 days to stabilize. Treatment options for STEMI include: March thrombus aspiration without balloon or stent implantation; Stabilization with drug therapy in a relatively small hospital that does not provide PCI, and transfer to a tertiary hospital for further evaluation; Thrombolytic therapy.
15733583|NCT04996277|Procedure|Thrombus suction|All STEMI patients will be treated according to the hospital's standard procedures and the plaque will be monitored for 7-30 days to stabilize. Treatment options for STEMI include: March thrombus aspiration without balloon or stent implantation; Stabilization with drug therapy in a relatively small hospital that does not provide PCI, and transfer to a tertiary hospital for further evaluation; Thrombolytic therapy.
15733584|NCT04996277|Procedure|Fibrinolytic therapy|All STEMI patients will be treated according to the hospital's standard procedures and the plaque will be monitored for 7-30 days to stabilize. Treatment options for STEMI include: March thrombus aspiration without balloon or stent implantation; Stabilization with drug therapy in a relatively small hospital that does not provide PCI, and transfer to a tertiary hospital for further evaluation; Thrombolytic therapy.
15733585|NCT04996277|Behavioral|Medication stabilized the condition|All STEMI patients will be treated according to the hospital's standard procedures and the plaque will be monitored for 7-30 days to stabilize. Treatment options for STEMI include: March thrombus aspiration without balloon or stent implantation; Stabilization with drug therapy in a relatively small hospital that does not provide PCI, and transfer to a tertiary hospital for further evaluation; Thrombolytic therapy.
15733586|NCT04996264|Drug|Varespladib Methyl|Varespladib-methyl (LY333013) is an IR, oval, white, film-coated tablet at a dosage strength of 250 mg for oral administration. Scaled pediatric doses of varespladib-methyl (LY333013) are supplied as 50 mg IR capsules for oral administration.
15733587|NCT04996264|Drug|Placebo|"The oral placebo is supplied as a white film-coated oval tablet to match the appearance of the varespladib-methyl 250 mg tablet and contains a subset of the excipients present in the active tablet formulation: lactose monohydrate, microcrystalline cellulose, and magnesium stearate.
~Placebo for scaled pediatric dosing is supplied as an IR capsule to match the varespladib-methyl 50 mg capsule, and contains the excipients lactose monohydrate, microcrystalline cellulose, and magnesium stearate."
15733588|NCT04996264|Drug|Standard of care (SOC)|SOC (including antivenom) will continue to be administered throughout the subject's participation in the study according to the protocol and the judgment of the Investigator.
15733589|NCT04996251|Drug|Bupivacaine Injection|0.25% Bupivacaine being used as local anesthetic to inject into incision sites of tracer sites during a laparoscopic/robotic-assisted sacrocolpopexy
15733590|NCT04996238|Procedure|Blood and nasal fluid sampling before and after COVID-19 vaccination|Blood and nasal fluid sampling take place just before the first COVID-19 vaccination and at 14-30 days after the second dose with the same vaccine. At both moments, a questionnaire is filled in.
15733591|NCT04996225|Other|Aerobics exercises, Balance exercises|Aerobic exercise, or endurance exercise, is a subdivision of physical exercise that improves cardiovascular and respiratory health. Additionally, it is generally assumed to increase well-being and reduce negative mood states such as anxiety and depression.
15733592|NCT04996212|Procedure|Educational Group|"The subjects that make up this first group will receive health education and regular follow-up from their health center or referral hospital.
~They will be provided, via email, a dossier with updated information on COVID-19 and persistent covid; as well as some general recommendations on the management of COVID-19 and its sequelae. Participants will be asked to fill out a physical activity diary, in which the exercise performed each week is recorded. Each individual must write down the number of exercise sessions performed; its duration; the type of activity carried out (aerobic or strength exercise); the intensity of work; and the degree of perceived exertion"
15733593|NCT04996212|Procedure|Respiratory physiotherapy group|"The intervention of this group will be based on two breathing exercises (abdominal-diaphragmatic breathing and pursed-lip breathing), which will be combined during the work sessions.
~Participants must perform the proposed exercises, 5 days a week, once a day In addition to the respiratory physiotherapy guideline, they will be given the health education manual."
15733594|NCT04996212|Procedure|Walking Group|"Participants assigned to this group will perform a progressive walking protocol and breathing exercises (abdominal-diaphragmatic breathing and pursed-lip breathing), in addition to receiving the health education manual.
~Patients should go for a walk 3 times a week15,88,91,92,93, thus leaving a minimum of 24 hours between sessions94.
~The duration of the walk will vary every two weeks, ranging between 25 and 45 minutes15"
15733595|NCT04996212|Procedure|Functional exercise group|The randomized subjects in this last group will follow a therapeutic program that will combine functional exercise and respiratory exercises.Functional training will consist of performing 10 different exercises, which involve the activation and performance of the large muscle groups
15747696|NCT04878523|Dietary Supplement|multi berries juice|Testing product
15733600|NCT04996173|Device|Ballon Dilation|An endoscopic balloon that is inflated with water to pressures between 45 and 131 psi (3 to 9 atm) using a syringe and pressure manometer.
15733601|NCT04996173|Device|Radial Incision|Carbon dioxide (CO2) laser or Monopolar electrocautery knife
15733602|NCT04996160|Drug|Palbociclib|Oral
15733603|NCT04996160|Drug|Dexamethasone|8 mg/m2/day divided BID, PO, NG, or IV
15733604|NCT04996160|Drug|Bortezomib|1.3 mg/m2/dose, IV (preferred) or SC
15733605|NCT04996160|Drug|Doxorubicin|25 mg/m2/dose IV
15733606|NCT04996134|Drug|Domperidone Oral Product|10-30 mg of oral domperidone administered QID.
15733607|NCT04996121|Drug|XZP-5955 tablets|"Phase I dose escalation:
~For each dose cohort, XZP-5955 tablet will be administered orally, single dose for day 1 and then from day 4, administered for continuous cycles of 21 consecutive days for each cycle
~Phase I dose expansion:
~XZP-5955 tablet will be administered orally, once daily for continuous cycles of 21 consecutive days for each cycle. Some patients for PK sample collection, the drug will be administered single dose for day 1, then from day 4, administered for continuous cycles of 21 consecutive days for each cycle
~Phase II:
~XZP-5955 tablet will be administered orally, once daily for continuous cycles of 21 consecutive days for each cycle"
15733609|NCT04996056|Drug|TNX-1300|TNX 1300 200 mg Intravenous injection
15733610|NCT04996056|Other|Usual Care|Usual Care per the Emergency Department protocol for Cocaine Intoxication
15733611|NCT04996043|Dietary Supplement|Collagen Peptide Drink|Testing product
15733612|NCT04996043|Dietary Supplement|Placebo drink|Blank
15733613|NCT04996030|Drug|SY-2101|SY-2101 will be administered per dose and schedule specified in arm description.
15733614|NCT04996030|Drug|Arsenic Trioxide|IV ATO will be administered per dose and schedule specified in arm description.
15733615|NCT04996017|Drug|Atezolizumab 1200 mg in 20 ML Injection|Atezolizumab will be supplied as sterile liquid in 20-mL glass vials. The vial is designed to deliver 20 mL (1200 mg) of atezolizumab solution but may contain more than the stated volume to enable delivery of the entire 20 mL volume. For information on the formulation and handling of atezolizumab, refer to the Atezolizumab Investigator's Brochure.
15733616|NCT04996017|Drug|Placebo|Placebo will be supplied as sterile liquid in 20ml vials. the vial is designed
15733617|NCT04996004|Drug|TTI-621|TTI-621 will be administered by intravenous infusion.
15733618|NCT04996004|Drug|Doxorubicin|75 mg/m^2 by intravenous infusion on Day 1 of each 21-day cycle for a maximum of 6 cycles.
15733619|NCT04995991|Behavioral|RRT rhythm only|RRT is a child-friendly computerized reading training program designed for Italian students with DD aged 8-14 yrs. The main feature of this intervention is the integration of a traditional remediation approach (sublexical treatment) with rhythm processing. Therefore, all reading exercises are characterized by a rhythmic accompaniment with gradually increasing speed. In this condition, the RRT activities comprise only a rhythm accompaniment and no visual cue.
15733620|NCT04995991|Behavioral|RRT rhythm + visual cue|RRT is a child-friendly computerized reading training program designed for Italian students with DD aged 8-14 yrs. The main feature of this intervention is the integration of a traditional remediation approach (sublexical treatment) with rhythm processing. Therefore, all reading exercises are characterized by a rhythmic accompaniment with gradually increasing speed. In this condition, the rhythmic accompaniment is synchronize with a visual cue (the verbal stimuli are highlighted using a red font in synchrony with the rhythm).
15733621|NCT04995978|Drug|Pioglitazone 30 mg|"Subjects will self-administer a 30 mg pioglitazone oral tablet daily for 6 months.
~For patient taking a diabetic regimen of gemfibrozil, the dose will be 15 mg daily."
15733622|NCT04995978|Drug|placebo tablet|Subjects will self-administer an oral placebo tablet containing cellulose daily for 6 months.
15733623|NCT04995952|Behavioral|Gross motor training|Gross motor training activity (1 hour session, 3 times a week for 3 months). Pre ad post assessments will be taken. The Gross motor training activity will include: sit to stand, step-ups and walking. The sit to stand will be performed for 20 minutes involving 20 repetitions. We will progress from high seat sit to stand to low seat sit to stand. The step up will progress initially from a bench having low height to high height and then to stepping of stairs for 20 minutes involving 30 repetitions. The walking will occur from 3m walk and then increasing the distance
15733624|NCT04995952|Behavioral|Trunk targeted training|"Trunk targeted training (1hour session, 3 times a week for 3 months). Pre and Post assessment will be evaluated. The trunk targeted training will include: weight supported treadmill walk, specific trunk exercises with vibration therapy and reaching forward to the limits of stability.
~Specific trunk exercises will involve stride sitting to standing, sitting on a roll and moving the roll in diagonal and forward backward directions along with giving vibrational therapy on wobble board, side sitting. This activity will be performed for 30 minutes with 30 repetitions. Reaching forward to the limits of stability exercises will be performed. Asking the children to hold objects from right hand while reaching for an object on left side and vice versa. This will be performed for 20 minutes having 20 repetitions."
15733625|NCT04995939|Procedure|Laboratory parameters and Scoring systems|Neutrophil/ Lymphocite ratio, albumin level and scoring systems has been evaluated.
15733626|NCT04995926|Procedure|Labial mucosal epithelium grafting for corneal limbus substitution|Labial mucosa epithelium grafting for corneal limbus substitution will be used to treat limbal stem cell deficiency by way of corneal surface re-epithelization
15733627|NCT04995913|Other|Online cognitive behavioral therapy|The intervention includes 9 online modules, 3 face-to-face/online/telephone counseling sessions, and 2 sessions of virtual reality exposure therapy. Participants will learn and practice a variety of the cognitive behavioral skills to cope with their social anxiety. The functions of the EASE Online Program include animation briefing and debriefing, case demonstration videos, assignment and feedback, forum, internal messaging, reminder, online assessment, online booking and progress checking. The duration of the intervention is 14 weeks.
15733628|NCT04995900|Other|Community education|Heart Matters coordinators will deliver heart health education to the community using HM materials and Partner resources.
15733649|NCT04995653|Drug|Vancomycin Placebo|Four times daily dosing with Vancomycin Placebo
15733650|NCT04995653|Drug|SER-155|Once daily dosing with SER-155
15733629|NCT04995887|Device|Jada® System|The Jada® System is intended to provide control and treatment of abnormal postpartum uterine bleeding or hemorrhage when conservative management is warranted. It is a teardrop-shaped, soft silicone ring that is placed into the uterus, where gentle suction is applied to cause the uterus to contract and shrink in size, compressing the blood vessels so the bleeding stops.
15733630|NCT04995874|Dietary Supplement|KOKOPlus protein and micronutrient powder|KokoPlus, a complementary food supplement was formulated by using linear programming methodology to improve the protein quality as well as the micronutrient and macronutrient content of commonly consumed traditional complementary (baby) foods in Ghana . It contains soya powder, sugar and oil along with the essential amino acid lysine and a micronutrient mix. It complies with WHO's complementary feeding guidelines, FAO/WHO recommended micronutrient intake (RNI) and the WHO's guidelines for protein and essential amino acid intake for children in the age group of 6 to 24 months. A daily supply of KokoPlus achieves 30% of the total recommended energy, 60% of total protein and 40% of total fat requirements from complementary foods. It also meets 35-55% of minimum intake of essential amino acids and 50-150% RNI based on the total daily requirements.
15733631|NCT04995861|Procedure|Adductor canal block and IPACK block|Peripheral nerve blocks
15733632|NCT04995848|Other|Telepalliation|Telepalliation platform Telepal.dk
15733633|NCT04995835|Drug|Cefiderocol|After receipt of Cefiderocol, blood samples will be collected at various time points to determine the pharmacokinetics of Cefiderocol
15733634|NCT04995822|Device|hip arthroplasty|Hip prosthesis surgery
15733635|NCT04995796|Other|Surveys for Research Purposes|"VISIT #1:
~Pre-Testing:
~Pre Knowledge Test
~Pre SURE (decisional conflict) test
~Independent DSI/DA Interaction
~Post-Testing:
~Post Knowledge Test
~Post SURE (decisional conflict) Test
~Acceptability Index
~Modified Single Item Literacy Screen
~Additional Demographics
~VISIT #2: Check-In Call 1 week later:
~After viewing the DSI/DA and completing the post-test components above, the subjects will also complete a 5 minute debrief interview about 1 week later via phone or video conference with a team member to give feedback on their experience using the DSI/DA, including its strengths and weaknesses. This will allow for further improvement and refinement of the DSI."
15733636|NCT04995783|Diagnostic Test|Coral FRS test|A novel clinical test to predict autoimmune medication response
15733637|NCT04995770|Behavioral|Praise Text Messages|Texting messages with praise content, to positive reinforce medication adherence
15733638|NCT04995757|Device|Stent Retriever|Stent Retriever for acute ischemic stroke
15733639|NCT04995744|Procedure|Pectoralis Major Pedicle Bone Graft|It is aimed to restore the integrity of the medial cortex with the bone pedicle from the insertion region of the pectoralis major muscle in middle-aged patients with Neer type 4 proximal humerus fractures. Researchers aim to reduce the risk of avascular necrosis with a vascular living bone tissue, as well as providing mechanical support with this method. The investigators aim to reduce the risk of avascular necrosis with a vascular living bone tissue, as well as providing mechanical support with this method.
15733640|NCT04995731|Behavioral|Information about clinical risk factors for endometrial cancer and endometrial hyperplasia (EH)|Bleeding type, age, race, parity, early menarche or late menopause, body mass index, body composition, hypertension, type II diabetes, anovulation, polycystic ovary syndrome and smoking history. Other epidemiologic risk factors including tamoxifen exposure, history of breast cancer, current hormone therapy use, anticoagulant use, oral contraception use, family history of endometrial, breast or colon cancer.
15733641|NCT04995731|Procedure|transvaginal ultrasound examination|All patients will undergo a standard transvaginal ultrasound examination followed by power Doppler endometrial vascularity assessment. After ultrasound examination, all patients will undergo endometrial sampling either through hysteroscopy or dilatation and curettage operation (D, C) or will have histopathological evaluation of biopsy specimens obtained by hysterectomy. Histopathological evaluation will serve as a gold standard for the ﬁnal diagnosis.
15733642|NCT04995718|Other|Intelligent Physical Exercise Training (IPET)|Wind technicians performed 1-hour weekly individualized physical exercise training during working hours. The specific content of the exercise program was based on the specific job exposure profile, the physical capacity profile and the physical health profile of the employee.
15733643|NCT04995705|Behavioral|Acceptance and Commitment Therapy (ACT)|"ACT is a psychological intervention. ACT encourages individuals to remain open to internal experiences (positive, negative and neutral), rather than attempting to control or ameliorate them (which may only serve to increase pain and suffering). It also encourages individuals to focus on committing to a life that is congruent with their core values, regardless of the experiences that show up for them. The premise of this model is to learn to modify the relationship one has with their internal experiences (thoughts, feelings, physical sensations etc.), rather than change the experiences per se. This is achieved through different processes including mindfulness, acceptance, defusion and exploration of values. These core tenets of ACT help to cultivate psychological flexibility.
~This ACT intervention is delivered as a 5-week group for stroke survivors and adults with brain injury. It comprises of experiential and didactic components."
15733644|NCT04995692|Behavioral|Telehealth Education for Asthma Connecting Hospital and Home|TEACHH aims to provide educational support to families managing childhood asthma throughout the transition from hospital to home, and includes several core components: 1) Health literacy-informed inpatient teaching for child and caregiver including pictorial materials, hands-on demonstration, and use of teach-back/show-back techniques; 2) Facilitated identification of rescue and controller medications using color- and shape-coded medication labels and a pictorial asthma action plan; and 3) A pair of virtual follow-up visits after discharge to reinforce inpatient teaching and support families during the shift from acute exacerbation to preventive care management. Virtual visits will be completed using the Zoom platform on smartphones or other compatible devices, 2-4 days after discharge (first visit) and 3 weeks after discharge (second visit). All intervention activities will be completed within 1 month of discharge.
15733645|NCT04995692|Behavioral|Standard Care (SC) Comparison Group|Patients in the SC group will receive standard impatient management, including pre-recorded asthma education videos shown prior to discharge and the hospital action plan. PCP follow-up with be scheduled within a week of discharge. All SC measures will also be provided to subjects randomized to TEACHH.
15733646|NCT04995679|Procedure|Implant of metaphyseal sleeves in Total knee arthroplasty|Implant of metaphyseal sleeves in Primary and revision TKA
15733647|NCT04995666|Device|Phonak Audeo hearing aid|Rechargeable hearing aid
15733648|NCT04995653|Drug|Vancomycin Pre-Treatment|Four times daily dosing with Vancomycin
15733652|NCT04995640|Procedure|open cardiovascular repair or endovascular treatment (TEVAR)|Surgery type: open cardiovascular repair and endovascular treatment (TEVAR)
15733653|NCT04995627|Dietary Supplement|Salt (NaCl)|12 grams of salt (NaCl) per day
15733654|NCT04995627|Other|Placebo|Placebo
15733655|NCT04995614|Drug|Radium-223|Prospective observational cohort study investigating patient-reported outcomes
15733656|NCT04995601|Device|RF Health MAC|The RF Health MAC is a novel device that is applied to the lower legs of patients that provides intermittent active compressions to the calf muscles which results in increased blood flow in the veins, moving blood towards the direction of the heart and reducing the risk of clot formation.
15733657|NCT04995588|Other|Blood test|Unique blood draw of 45mL for all the participants
15733658|NCT04995575|Procedure|collection of the biopsy, blood samples|"for the patients recruited retrospectively collection of biopsy is not considered intervention, as the relapse samples were collected according to standard of care in the participating hospitals.
~For the prospective collection of samples, the relapsed patients will be asked to donate tissue and blood samples"
15733659|NCT04995562|Drug|129Xe|Inhaled contrast for MRI
15733660|NCT04995549|Device|Cutiscan® CS 100|Repeated measures on healthy volunteers skin (forearm) are performed using Cutiscan® CS 100 device
15733661|NCT04995536|Biological|CpG-STAT3 siRNA CAS3/SS3|Given intratumorally
15733662|NCT04995536|Radiation|Radiation Therapy|Undergo radiation therapy
15733663|NCT04995523|Drug|AZD2936|Anti-TIGIT/Anti-PD-1 Bispecific Antibody
15733664|NCT04995510|Other|Observational|To evaluate your chronic obstructive pulmonary disease with Chronic Obstructive Pulmonary Disease assessment test, respiratory muscle strength with intraoral pressure measurement device, respiratory muscle endurance with increasing threshold load respiratory muscle endurance test, diaphragm thickness with ultrasound device, cardiorespiratory fitness with 6 Minute Walk Test, flexibility trunk lateral flexion test , back scratch test and sit and lie down test, muscle strength and endurance will be evaluated with push-up test, sit-up test, sit and stand test and hand grip strength, body composition will be evaluated by bioelectrical impedance analysis, physical activity will be questioned with the International Physical Activity Assessment Questionnaire, shortness of breath with the Mmrc Dyspnea Scale, and perception of fatigue and shortness of breath with the Modified Borg Scale.
15733665|NCT04995497|Drug|Intravenous Administration of Lidocaine Post Cardiac Surgery|Lidocaine will be administered via intravenously. Initial dose will be at 2 mg/kg ideal body weight followed by dosing at 2 mg/kg/hr for 48 hours
15733666|NCT04995497|Drug|Administration of Lidocaine Post Cardiac Surgery via ESP Catheter|Lidocaine will be administered via ESP catheter. Initial dose will be at 2 mg/kg ideal body weight split between two catheters followed by dosing at 2 mg/kg/hr for 48 hours
15733667|NCT04995484|Drug|Belzutifan|Three 40 mg tablets given as a single oral 120 mg dose.
15733668|NCT04995471|Behavioral|In presence RRT - prototype software|Rhythmic Reading Training (RRT) is a prototype software which includes reading exercises presented simultaneously with a rhythmic stimulation with gradually increasing speed.
15733669|NCT04995471|Behavioral|In presence RRT - online platform|"RRT is a web application with a client-server structure developed in javascript/php language using open-source support libraries. The server-side system uses a LAMP stack (Linux, Apache, Mysql, Php) on Server Cloud. The application can also be activated as a desktop application through portable web server installation systems, available for linux, windows and OS operating systems. In this form, the application can also be used in contexts without an Internet connection. The system is also accessible from tablets. RRT consists of a module of progressive reading exercises. The exercises are organized according to different types (syllables, words, non-words, short texts) and accompanied by a rhythmic-melodic stimulation, which is coordinated with a visual cue. Both remote (Rhythmic Reading Tele-Training, RRTT) and in presence administration (RRT) are available."
15733670|NCT04995471|Behavioral|Tele-RRT - prototype software|Rhythmic Reading Training (RRT) is a prototype software which includes reading exercises presented simultaneously with a rhythmic stimulation with gradually increasing speed.
15733671|NCT04995471|Behavioral|Tele-RRT - online platform|"RRT is a web application with a client-server structure developed in javascript/php language using open-source support libraries. The server-side system uses a LAMP stack (Linux, Apache, Mysql, Php) on Server Cloud. The application can also be activated as a desktop application through portable web server installation systems, available for linux, windows and OS operating systems. In this form, the application can also be used in contexts without an Internet connection. The system is also accessible from tablets. RRT consists of a module of progressive reading exercises. The exercises are organized according to different types (syllables, words, non-words, short texts) and accompanied by a rhythmic-melodic stimulation, which is coordinated with a visual cue. Both remote (Rhythmic Reading Tele-Training, RRTT) and in presence administration (RRT) are available."
15733672|NCT04995458|Procedure|composite-ceramic|To assess the clinical performance of composite-ceramic crowns
15733673|NCT04995458|Procedure|Monolithic zirconia|To assess the clinical performance of monolithic z¡irconia crowns
15733674|NCT04995419|Drug|Enfortumab vedotin|Intravenous Infusion
15733675|NCT04995406|Diagnostic Test|ISIT-TB prototype|Diagnostic assay able to identify active tuberculosis using a patient blood sample processed on an automatized system within an hour
15733676|NCT04995393|Procedure|Heating with a disposable glove containing water|Heating of the infants heel with a glove before blood sampling.
15733677|NCT04995393|Procedure|Heating with a blanket|Heating of the infants heel with a blanket before blood sampling.
15733678|NCT04995393|Procedure|Heating with a gel pack|Heating of the infants heel with a gel pack before blood sampling.
15733679|NCT04995380|Procedure|Early Cholecystectomy|Cholecystectomy performed within 10 days from onset of symptoms
15733680|NCT04995367|Device|Implementation of a BCI system integrated to the T-FLEX lower-limb exoskeleton in post-stroke patients.|The participants will carry out 4 tasks with a BCI system integrated to the T-FLEX device. The task consists of 1 session that includes 4 conditional experiments: Active ankle movement, passive ankle movement, Motor Imagery Detection with Visual cue, and Motor Imagery Detection with Tactile Stimulation and visual cue.
15733681|NCT04995354|Drug|EGF loaded Hydrogel|Patients will receive 25 Ug/day of EGF. This is the estimated daily dose that will be obtained when the patient applies the gel thrice daily. Patients will receive the treatment for one week
15747697|NCT04878523|Dietary Supplement|Placebo drink|Blank
15733683|NCT04995341|Device|Investigational ultracompact OCT and OCTA system|Handheld bedside retinal OCT and OCT angiography imaging with an investigational portable system with ultracompact handpiece
15733684|NCT04995341|Device|retinal photographs|retinal photographs with a commercial portable bedside widefield fundus camera system
15733685|NCT04995328|Other|Radiation Care Gel|The investigational medical product of this study is a hydrogel, Radiation Care® gel which increases moisturizing and it can be applied to the target areas including skin folds and creases.
15733686|NCT04995302|Procedure|Microoneedling and Amnion Bilayer|Microneedling is conducted following a three-week application of tretinoin cream. Then, scar tissue that has been treated with microneedling is covered with amnion bilayer for 72 hours.
15733687|NCT04995302|Procedure|Microoneedling|Microneedling is conducted following a three-week application of tretinoin cream. Then, scar tissue that has been treated with microneedling is covered with an antibacterial gauze dressing.
15733688|NCT04995289|Other|Prone position on ECMO patient|blood gas analysis before and after PP
15733689|NCT04995263|Behavioral|Sueña component 1: Sleep Hygiene Promotion|The nursery staff will be instructed to promote sleep hygiene. Nurse technicians will: inform patients of the efforts to ensure a healthy sleep environment, verify the minimization of light and noise after 23:00 PM, favour natural light after 07:00 AM, and foment patient's activities and participation in group therapy. Nurses will: reduce sleep interruptions to a minimum, to only perform actions (i.e. blood testing, clinical controls, medicine administration) deemed strictly necessary between 23:00 PM and 07:00 AM. A list of commonly used medications with their pharmacodynamic and pharmacokinetic properties tailored by a pharmaceutical chemist will be provided, to ensure optimal medication administration while protecting the guaranteed sleep hours, to be coordinated with the treating physician.
15733690|NCT04995263|Behavioral|Sueña component 2: Periodic Anxiety and Pain Screening|Every night, nursery staff will include anxiety and pain screenings as part of vital signs assessments, using visual analog scales for each one. If any screening is altered, clinical actions will be performed to alleviate symptomatology if deemed necessary, using clinical judgement.
15733691|NCT04995263|Behavioral|Sueña component 3: Hypnotics and Caffeine Regulation|The use of hypnotics will be standardized to be administered no later than at 22:00 PM; in the case of melatonin, its administration will be suggested at sundown, at 20:00 PM. Caffeinated drinks will be prohibited after 15:00 PM.
15733692|NCT04995263|Behavioral|Sueña component 4: Sleep Masks and Ear Plugs|Sleep masks and ear plugs will be available to all patients if they wish to use them. The nursery team will reinforce its use between 23:00 PM and 07:00 AM.
15733693|NCT04995263|Other|Sueña component 5: Personalized Psychoeducation|Two individualized, nurse-led psychoeducation PowerPoint presentations on sleep hygiene will be presented to patients, supported by educational material aimed at the patient and their families.
15733694|NCT04995263|Device|Sueña component 6: Sleep Reports|Objective and subjective reports of sleep quality will be handed to attending psychiatrist, using data gathered with wearable devices (Fitbit Charge 4) and self-report questionnaires regarding perceived sleepiness and overall sleep. The psychiatrist in charge uses said information in the routine case management
15733695|NCT04995250|Other|corrective exercise training for knee|All patients received 12 weeks (3 days per week) physiotherapy sessions with hot pack, TENS and Ultrasound session for 10 mints and knee isometric, quad strengthening, adductor and abductor strengthening, calf stretch, hamstring stretch, Maitland mobilization, Unconventional Corrective knee exercise protocol treatment: standing on one extremity, up and down on bosu exercise, walking to lateral direction, walking to anterio-posterior direction, walking to anterio-posterior and lateral for 20 mints. Data were collected at baseline, at week 4 and at post treatment (week 12).
15733697|NCT04995224|Other|Assessment of Psychophysiological factors|Investigating the presence of psychophysiological factors (depression, anxiety, catastrophizing) by questionnaires.
15733698|NCT04995224|Biological|Assessment of Biological factors|Investigating autonomic nervous function using heart rate recording, colon biopsy samples, microbiota, and blood cytokines levels. (Colon biopsy samples are obtained when colonoscopy is performed for clinical reasons. Blood samples and stool samples will be taken when participants come to the hospital for colonoscopy)
15733699|NCT04995224|Genetic|Assessment of Genetics|Genetic data investigated by another cohort study (IBD BioResource study) will be utilized in the analysis of this study.
15733700|NCT04995224|Behavioral|Assessment of Quality of Life|Investigating QOL by questionnaires.
15733701|NCT04995224|Biological|Assessment of Biological factors|Investigating colon biopsy samples (Colon biopsy samples are obtained when colonoscopy is performed for clinical reasons).
15733702|NCT04995211|Device|Assessment of resting energy expenditure|We will assess the resting metabolic rate and respiratory exchange ratio of twenty healthy adults, with every metabolic cart on two days in the morning. The assessment will last 30 minutes on each metabolic cart, with 15-minute breaks between measurements. The order of the metabolic carts will be randomly selected and replicated the second day.
15733703|NCT04995185|Radiation|(18)F-fluoromisonidazole (FMISO)|Patients do not need to be fasted prior to intravenous injection of 370MBq ± 10% (18)F-fluoromisonidazole. Scanning will be performed two hours after the injection. Patients will be scanned with their thermoplastic shell used in routine radiotherapy treatment for 10 minutes, followed by approximately 5 minutes scan of the upper chest.
15733704|NCT04995172|Procedure|Computed Tomography|Undergo mobile CT-assisted bronchoscopy
15733705|NCT04995172|Other|Electronic Health Record Review|Patients' medical records are reviewed
15733706|NCT04995172|Procedure|Endobronchial Ultrasound Bronchoscopy|Undergo radial probe EBUS
15733707|NCT04995159|Drug|Single anti-platelet therapy|Aspirin in combination with a P2Y12 receptor antagonist (either clopidogrel or ticagrelor will be selected by investigators according to the degree of ischemia) in the first year after PCI. Aspirin will be discontinued one year after surgery and clopidogrel will be continued until 5 years after surgery.
15733744|NCT04994873|Behavioral|Enhanced TAU|Standard care plus a phone app with a personalized safety plan
15733745|NCT04994860|Drug|BIA 5-1058|Oral BIA 5-1058 (Zamicastat) 100 mg tablets
15733746|NCT04994860|Drug|Sildenafil|Oral Sildenafil ( Revatio) 20 mg film coated tablets
15733708|NCT04995159|Drug|Dual anti-platelet therapy|Aspirin in combination with a P2Y12 receptor antagonist (either clopidogrel or ticagrelor will be selected by investigators according to the degree of ischemia) in the first year after PCI. Patients continue to take dual antiplatelet (DAPT) drugs, including aspirin and clopidogrel, for 2 more years; then aspirin will be used alone from the 4th year to the 5th year.
15733709|NCT04995146|Other|Clinical stroke extended management pathway|"Extracranial imaging
~ECG in 2-7 days
~DVT prophylaxis
~Stroke educational material for patient and family Removal of Foley's catheter and start bladder management
~Discharged on: Antithrombotic therapy OR Anticoagulation therapy▸ Antihypertensives ▸ Statins/cholesterol lower agent ▸ Antidiabetic agent
~Fasting lipid profile, HbA1c
~Holter monitor
~Specialized workup for young stroke
~PFO Study, MES Study
~Referral to: ▸ Rehabilitation specialist ▸ Speech therapist ▸ Dietician ▸ Occupational therapist ▸ Medical team
~Follow-up: CTA, CT angiography; HbA1c, glycated haemoglobin; MRA, MR angiography
~Follow-up plan and 90 day mRS"
15733710|NCT04995133|Drug|Colistin|intravenous administration
15733711|NCT04995120|Drug|chemotherapy TP regimen combined with Toripalimab|"Induction chemotherapy TP regimen combined with Toripalimab for 3 cycles: Toripalimab 240mg d1, Paclitaxel 175mg/m2 d2 or Nab-Paclitaxel 260mg/m2 d2，Cisplatin 25mg/m2 d2-4 q3w.
~Response rate of primary tumor is evaluated using laryngoscopy and head and neck MRI after 3 cycles of induction therapy. If overall response rate of primary tumor is complete response or partial response, then chemoradiation is conducted, followed by maintenance therapy of Toripalimab for 1year. Otherwise, surgery is conducted (laryngeal preservation surgery is preferred), followed by adjuvant radiation/chemoradiation and then maintenance therapy of Toripalimab for 1year."
15733712|NCT04995107|Device|Electro Press needle|"Body acupoints will be stimulated by the press needles 0.25mm in diameter and 2mm in length and ear acupoints will be stimulated by the press needles 0.25mm in diameter and 0.9mm in length (all from ZhenXing Brand, Hangzhou Yuanli Medical Appliance Factory, China). After sterilization of the local skin, the needle will be pressed to the acupoints and the tape will be sticked to the skin. Then, the electric device (φ44×15.8mm Type ZXHPAMDZB-02C) together with the electrode patch will be sticked to the surface of skin (on top of the sticky tapes of the press needle) in the area of CV4 and bilateral EX-CA1, and bilateral SP6 respectively. The electric device will be switch to the mode of dense intermittent wave, and the current intensity will be increased gradually till the muscles around jumps slightly.All the needles on the body acupoints will be removed after each session, while those on the auricular acupoints can be kept for as long as 6 hours (removed before going to bed)."
15733713|NCT04995094|Biological|Imprime PGG|Imprime PGG is a soluble, β-1,3/1,6 glucan isolated from the cell wall of a proprietary Saccharomyces cerevisiae yeast strain. Imprime PGG acts as a Pathogen-Associated Molecular Pattern (PAMP). Imprime will be administered at a dose of 4 mg/kg IV over a 2-hour infusion time on Days 1, 8 and 15 of each 3-week treatment cycle.
15733714|NCT04995094|Biological|Pembrolizumab|Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 (PD-1) protein. Pembrolizumab will be administered at 200 mg IV Q3W for 9 weeks.
15733715|NCT04995081|Biological|Biological/Vaccine: Allogeneic HB-adMSCs|HB-adMSCs will be administered intravenously to study participants who qualify.
15733716|NCT04995081|Other|Placebo|Sterile Saline Solution 0.9%
15733717|NCT04995068|Radiation|Head CT to determine presence of traumatic intracranial lesion|Head CT to determine presence of traumatic intracranial lesion
15733718|NCT04995042|Drug|SHR7280|Drug: SHR7280 All participants receive SHR7280 alone.
15733721|NCT04995016|Drug|Pembrolizumab|PD-1 inhibitor，Pembrolizumab 200mg IV, every 3 weeks.
15733722|NCT04995016|Drug|Axitinib|Tyrosine kinase inhibitor，licensed for use in treatment of renal cell carcinoma. Oral treatment Axitinib given 5 mg PO BID.
15733723|NCT04995003|Genetic|cells|HER2 CAR T cells infused in combination with lymphodepletion chemotherapy
15733724|NCT04995003|Drug|Pembrolizumab Injectable Product|2 mg/kg/dose (max 200 mg/dose) every 3 weeks
15733725|NCT04995003|Drug|Nivolumab Injectable Product|3 mg/kg/dose (<40kg) or 124 mg (≥40 kg) every 2 weeks
15733726|NCT04995003|Drug|Lymphodepletion Chemotherapy|Fludarabine plus Cyclophosphamide
15733727|NCT04994990|Drug|AbobotulinumtoxinA|Half of face will receive standard dose of Botox
15733728|NCT04994990|Drug|AbobotulinumtoxinA|Half of face will receive double the standard dose of Botox
15733729|NCT04994977|Drug|Melphalan|Given at 0.5 mg/ml.
15733730|NCT04994977|Drug|Carboplatin|Given at 5 mg/ml.
15733731|NCT04994977|Drug|Topotecan|Given at 0.2 mg/ml.
15733732|NCT04994964|Diagnostic Test|Electromyography|Needle vocal cord electromyography using Medtronic NIM monitor
15733733|NCT04994951|Drug|Triamcinolone Acetonide Acetate and Urea Cream.|10g/tube and CalcipotriolOintment,10g/tube are used alternately.
15733734|NCT04994951|Drug|Qing-Re-Liang-Xue Decoction.|One dose of granules is mixed, poured into 500ml of boiling water, and taken twice in the morning and afternoon. Women stop taking Chinese medicine during the first 3 days of menstruation.The period of treatment will be 10 weeks.
15733735|NCT04994938|Other|Diet Intervention|Participants will engage in discussions about healthy eating one time per week led by a trained peer leader for 12-weeks.
15733736|NCT04994938|Other|Exercise Intervention|Participants will participate in a group exercise session led by a trained peer leader 2-times per week for 12-weeks.
15733737|NCT04994925|Other|Control ready meal|Supermarket brand lasagne ready meal
15733738|NCT04994925|Other|Test ready meal|The Slimming World lasagne ready meal
15733739|NCT04994912|Drug|EI-001|EI-001 IV infusion
15733740|NCT04994912|Other|Placebo|Placebo IV infusion
15733741|NCT04994899|Other|Aiberry Depression Detection AI Platform|Aiberry is a next-generation artificial intelligence (AI) company that leverages deep tech to screen for mental health and brain-related disorders.
15733742|NCT04994886|Procedure|Device implantation|The intervention involves the insertion of 2 lead electrodes (Specify Surescan 5-6-5 Leads, Model 977C190 Medtronic) epidurally over the dorsal aspect of the spinal cord through 2 laminectomies and two implantable pulse generators (Intellis™ with AdaptiveStim™, Model 97715 Medtronic) in the abdomen of the participant.
15733747|NCT04994847|Drug|Amyloid and Tau PET|NAV4694 and MK6240 PET scans completed every two years
15733748|NCT04994834|Dietary Supplement|Probiotics|Once a day daily intake of probiotics for at least 28 consecutive starting within 24 hours after birth
15733749|NCT04994821|Device|transcranial direct current stimulator (tDCS)|"Patients will have two electrodes applied (one anode, one cathode) administering active (real) or sham (placebo, not real) tDCS stimulation.
~Stimulation will last 20 minutes per day, three days per week, for 5 weeks"
15733750|NCT04994821|Behavioral|Cognitive Reappraisal|Emotion regulation therapy
15733751|NCT04994808|Drug|Clofarabine|Given IV
15733752|NCT04994808|Drug|Fludarabine|Given IV
15733753|NCT04994808|Procedure|Hematopoietic Cell Transplantation|Undergo HCT
15733754|NCT04994808|Radiation|Total-Body Irradiation|Undergo TBI
15733755|NCT04994808|Drug|Treosulfan|Given IV
15733756|NCT04994795|Other|Predictive models (data collection)|Machine learning predictive models
15733757|NCT04994782|Behavioral|GAME-EOL|The GAME-EOL involves Hello game booklets as well as meetings with an interventionist. Players (ICD recipient and their family member or friend dyad) take turns asking the questions in their booklet and providing their answers to the question. The gameplay continues until all questions are answered or the dyad wishes to stop. Following the completion of the game play, participants will be offered the opportunity to complete advance directives using the conversation guide and advance directive form included in the conversation guide that accompanies the questionnaire booklet.
15733758|NCT04994769|Device|Epitomee Capsule|Epitomee Capsule combined with lifestyle counseling.
15733759|NCT04994756|Procedure|Stroke/Thrombectomy/Aneurysm-specific surgical procedures|Participants are retrospectively and/or prospectively entered into registry based on disease indication and respective surgical procedure.
15733760|NCT04994743|Drug|CORT113176|CORT113176 lipid capsule formulation for oral administration
15733761|NCT04994743|Drug|Placebo matching CORT113176|Placebo matching CORT113176 lipid capsule formulation for oral administration
15733762|NCT04994730|Behavioral|Quality of life according to the reconstruction technique|"For this retrospective analysis, 118 patients could be included, 17 of whom had undergone ante-brachial free flap reconstruction, 16 of whom had undergone this reconstruction within the last 2 years.
~The primary endpoint: Analysis of the quality of life score according to the reconstruction technique (free ante-brachial flap versus others) will be performed by a Wilcoxon-Mann-Whitney test."
15733766|NCT04994704|Drug|Propfol group|Propfol group will be started and maintained total intravenous anesthesia with propofol and remifentanil under target controlled infusion (TCI) model.
15733767|NCT04994704|Drug|Remimazolam group|Remimazolam group will be started total intravenous anesthesia with remiamazolam at 6 mg/kg/h for induction, and maintained at 0.5-1.5 mg/kg/h and remifentanil under TCI model.
15733768|NCT04994691|Other|No Message|No messages are sent
15733769|NCT04994691|Other|Standard message|2 MyChart reminders that child is overdue for well child check visit
15733770|NCT04994691|Other|Tailored message|2 MyChart reminders that child is overdue for well child check visit with date of last WCC and age
15733771|NCT04994678|Other|Virtual Reality Training|The Virtual reality based training group will receive a game based virtual reality training via XBOX 360or wii fit balance games. Player will be required to rapidly leaning away, squat to avoid overhead obstacles and try small jump to avoid lower obstacles, single leg stance, in addition person will required to do half squatting, side to side jumps and vertical jumps. Treatment will be provided 3 times a week or 6 weeks with each session lasting for 30-50 minutes. Progressively challenge will be increased.
15733772|NCT04994678|Other|Moderate Aerobic Exercise Training|Moderate intensity continuous Aerobic exercises (Recombinant/Stationary cycling for 10-15 min with progression followed by treadmill walking for 10-15 min with progression, as well as stepping and Jogging). The session will be preceded by 5-7 minute warm-up &amp; 7-10 min cool-down.
15733773|NCT04994665|Procedure|sleeve gastrectomy|The sleeve gastrectomy is a surgical weight-loss procedure, about 80% of the stomach is removed
15733774|NCT04994665|Procedure|sleeve gastrectomy with omentopexy|After sleeve gastrectomy procedure, the omentopexy involves suturing the omentum back to the greater curvature of the stomach in several locations, depending on the length of the greater curvature
15733775|NCT04994652|Device|Videolaryngoscopy|Indirect laryngoscopy using the C-MAC videolaryngoscope
15733776|NCT04994652|Device|Direct laryngoscopy|Direct laryngoscopy with a standard laryngoscope
15733777|NCT04994639|Device|BP management with HPI guidance|The hemodynamic condition of the HPI group will be managed by HPI guidance which is derived by arterial pressure waveform information, including Eadyn, SVV, dP/dt.
15733778|NCT04994626|Drug|Ibrutinib Combined With Rituximab|"Drug: ibrutinib ibrutinib 560mg administered orally once daily. Other Name: Imbruvica
~Drug: rituximab rituximab 375mg/m² administered intravenously (IV)"
15733779|NCT04994613|Other|Sensory adaptive environment|A dedicated, private room that is set up in accordance with the patient's coping plan and individual needs regarding sound, light, activity level, and other stimuli.
15733780|NCT04994600|Other|Reduces number of question items|The number of alarm fatigue questions are reduced to about 15 in the CFA_2nd_phase group.
15733781|NCT04994574|Drug|tiotropium/olodaterol|From Visit 2(Baseline), test subjects will be use tiotropium/olodaterol inhaler once a day for 4 weeks. After that, visit the hospital at 4 weeks to receive examination and terminate participation.
15733808|NCT04994405|Procedure|Tourniquet Pressure|"The procedural intervention will be inflation of a pneumatic tourniquet to a lower than standard pressure as determined by the patient's SBP in hand and upper extremity surgery. The control will be inflation of a pneumatic tourniquet at a standard pressure of 250 mmHg in hand and upper extremity surgery.
~The tourniquet used will be the standard tourniquet used for hand and upper extremity surgery at our institutions - a tourniquet 18 inches in length and 3 inches in width manufactured by Stryker (Kalamazoo, MI) used in conjunction with a protective sleeve matched to the size of the tourniquet cuff which is provided by the manufacturer. Both pieces are supplied in a sterile packaging. No other tourniquets will be used."
15733782|NCT04994561|Drug|Study Drugs and Nutritional Supplements|"Step 1: 500 mg of metformin and increase their dose 500 mg every 2 weeks up to 2000 mg or until tolerable.
~Step 2: Once at tolerable daily metformin dose, subjects will take 140 mg of dasatinib along with 58 mg to 174 mg (based on body weight) bio-quercetin and 44.5 mg bio-fisetin. Subjects will take dasatinib, bio-quercetin and bio-fisetin for 2 consecutive days as described 4 times over one year (every 3 months) while participating on this study.
~Step 3: Two weeks after the first dasatinib dose is complete, subjects will start taking daily nutritional supplements of 1,500 mg glucosamine, 600 mg nicotinamide riboside and 500 mg trans-resveratrol.
~Step 4: Two weeks after starting daily supplements in Step 3, subjects will take a once weekly 6 mg dose of rapamycin.
~Once subject is taking rapamycin, they will continue on this intervention for 12 months."
15733783|NCT04994548|Procedure|Endosocpic resection of early esophageal tumor|under general anesthesia, by mucosectomy or endoscopic submucosal dissection
15733784|NCT04994535|Drug|OnabotulinumtoxinA|Injection
15733785|NCT04994535|Drug|Placebo|Injection
15733786|NCT04994522|Drug|Belzutifan|Three 40 mg tablets given as a single oral 120 mg dose.
15733795|NCT04994496|Behavioral|Two-week web-based self-help intervention based on principles of positive psychology|"The web-based self-help intervention consists of 14 exercises based on the following positive psychology domains: personal strengths, pleasure, gratitude, engagement (flow, mindfulness) and positive relationships.
~The (partly interactive) exercises are created to be implemented by the participants themselves without support of a therapist.
~Before starting the intervention, the participants are told that they will receive a daily email with an instruction for a short exercise over the period of two weeks. The participants are instructed to complete the exercises every day and are told that they will be asked to evaluate these exercises at the next appointment (post-test, week 2)"
15733796|NCT04994496|Behavioral|Two-week web-based text messages containing fun facts|"The web-based sham intervention consists of 14 text messages containing random interesting facts (fun facts).
~Before starting the sham intervention, the participants are told that they will receive a daily email with a text message to read every over the period of two weeks. The participants are instructed to read these text messages every day and are told that they will be asked to evaluate these exercises at the next appointment (post-test, week 2)"
15733799|NCT04994470|Behavioral|Two-week web-based self-help intervention based on principles of positive psychology|"The web-based self-help intervention consists of 14 exercises based on the following positive psychology domains: personal strengths, pleasure, gratitude, engagement (flow, mindfulness) and positive relationships.
~The (partly interactive) exercises are created to be implemented by the participants themselves without support of a therapist.
~Before starting the intervention, the participants are told that they will receive a daily email with an instruction for a short exercise over the period of two weeks. The participants are instructed to complete the exercises every day and are told that they will be asked to evaluate these exercises at the next appointment (post-test, week 2)."
15733800|NCT04994470|Behavioral|Two-week web-based text messages containing fun facts|"The web-based sham comparator consists of 14 text messages containing random interesting facts (fun facts).
~Before starting the sham comparator, the participants are told that they will receive a daily email with a text message to read every over the period of two weeks. The participants are instructed to read these text messages every day and are told that they will be asked to evaluate these exercises at the next appointment (post-test, week 2)."
15733801|NCT04994457|Device|Virtual Reality Visual Field|A head-mounted perimeter with a wireless remote connected to a laptop that monitors responses
15733802|NCT04994457|Diagnostic Test|Standard Automated Perimetry|Standard of care perimeter
15733803|NCT04994444|Drug|Nicoderm CQ 21Mg/24Hr Transdermal System|Nicoderm CQ patch started 3 weeks prior to quit date. Starting on quit date, patch/gum or patch/lozenge will be used for 8 weeks. Patch will be tapered over the 8 week period.
15733804|NCT04994431|Drug|Tamsulosin Hydrochloride|0.4mg orally nightly for the two days immediately prior to surgery and the morning of surgery.
15733805|NCT04994418|Dietary Supplement|Recommended sodium and low fructose diet|Upon completion of a 7 day dietary intervention of consuming the daily recommended sodium and low fructose contents we will investigate changes in ambulatory blood pressure, urinary sodium excretion, heart rate variability, secretion of inflammatory cytokines, and reactive oxygen species.
15733806|NCT04994418|Dietary Supplement|High sodium and low fructose diet|Upon completion of a 7 day dietary intervention of consuming the daily high sodium and low fructose contents we will investigate changes in ambulatory blood pressure, urinary sodium excretion, heart rate variability, secretion of inflammatory cytokines, and reactive oxygen species.
15733807|NCT04994418|Dietary Supplement|High sodium and high fructose diet|Upon completion of a 7 day dietary intervention of consuming the high sodium and high fructose contents we will investigate changes in ambulatory blood pressure, urinary sodium excretion, heart rate variability, secretion of inflammatory cytokines, and reactive oxygen species.
15733809|NCT04994379|Device|1 mA tDCS|One session with stimulation intensity of 1 mA.
15733810|NCT04994379|Device|1.5 mA tDCS|One session with stimulation intensity of 1.5 mA.
15733811|NCT04994379|Device|Sham tDCS|One session of sham stimulation.
15733812|NCT04994366|Other|Thank you card|A card thanking the patient for choosing NYU and entrusting us with their care. The card notifies the patient that they may receive a patient satisfaction survey after discharge.
15733813|NCT04994353|Dietary Supplement|No supplementation|1st Week: No supplementation
15733814|NCT04994353|Dietary Supplement|High Performance (HP) Inulin|2nd Week: Subjects consumed 20% v/v HP Inulin. Ingredients: 20 gram HP-Inulin diluted with 100 ml distilled water.
15733815|NCT04994353|Dietary Supplement|Isomalto-oligosaccharide (IMO)|3rd Week: Subjects consumed 20% v/v Isomalto-oligosaccharide (IMO). Ingredients: 20 gram IMO diluted with 100 ml distilled water.
15733816|NCT04994353|Dietary Supplement|Combination HP-Inulin and IMO|"4th Week: Subjects consumed20% v/v combination of HP-Inulin and Isomalto-oligosaccharide (IMO).
~Ingredients: 20 gram IMO-HP Inulin Mix diluted with 100 ml distilled water."
15733817|NCT04994353|Dietary Supplement|Dextrose solution|5th Week:Subjects consumed20% v/v Dextrose solution. Ingredients: 20 gram Dextrose powder diluted with 100 ml distilled water.
15733818|NCT04994353|Dietary Supplement|Glucose solution|6th Week:Subjects consumed 20% v/v Glucose solution. Ingredients: 20 gram glucose diluted with 100 ml distilled water.
15733819|NCT04994327|Other|Beta-glucan bread|Frozen bread is administered to the participants for home storage. Bread is thawed at home before consumption. Dosage: At least 3 slices of bread 6 days per week for 16 weeks
15733820|NCT04994314|Drug|nCaF2 primer|Calcium fluoride nanoparticles was added to conventional orthodontic primers to develop bioactive primer. This primer was examined previously for its biological and physical properties
15733821|NCT04994314|Drug|Control primer|Conventional orthodontic primer
15733822|NCT04994301|Diagnostic Test|Lung T1 MRI|Evaluation of lung T1 MRI to Assess Lung Disease
15733823|NCT04994288|Biological|Supaglutide injection|Supaglutide 1mg/0.5ml , 2mg/0.5ml ,3mg /0.5ml
15733824|NCT04994288|Other|placebo injection|placebo injection 0.5ml
15733825|NCT04994275|Procedure|Major elective surgery|This is an observational study regarding patients admitted to undergo a major elective surgery supposed to last more than an hour. Investigators will analyzed the incidence of postoperative infections up to 90 days after surgery according to the preoperative iron-stock status.
15733826|NCT04994262|Other|Menthol Lozenge|"In the study, Oka Menthol, a herbal lozenge produced by Otacı, will be used. Its formula contains: menthol 0.26%, eucalyptol 0.065%, thymol 0.0002%, camphor 0.0002%, anise oil, thyme oil, coltsfoot, marshmallow flower, bovine tail flower extracts, glucose and sucrose.
~Medical properties: Otacı Oka Menthol Pastil shows antibacterial and fungicidal properties with eucalyptol in its composition. Menthol is effective against local anesthetic, local antitussive and irritation. It also plays a mild analgesic role with camphor in its content. It has an antibacterial and antifungal effect with thymol, a phenolic antiseptic. Otaco Oka Menthol Pastilles also contain extracts of coltsfoot, cow's tail flower and marshmallow flower which are anti-irritant and expectorant."
15733827|NCT04994236|Drug|Hepatic artery infusion chemotherapy with FOLFOX regimens (oxaliplatin, fluorouracil, and leucovorin)|The FOLFOX regiments were given via hepatic artery catheterization, including oxaliplatin 85 mg/m2, leucovorin 400 mg/m2, fluorouracil bolus 400 mg/m2, followed by fluorouracil infusion 2400 mg/m2 for 46 hours. If no severe adverse events occurred, the treatment will be repeated every 3 weeks.
15733828|NCT04994223|Drug|Rivaroxaban 10 MG Oral Tablet [Xarelto]|rivaroxaban has shown improved results after revascularization for PAD in terms of limb survival
15733829|NCT04994210|Drug|Sintilimab|"To evaluate the short-term objective efficacy of sintilimab combined with chidamide in the treatment of newly diagnosed ENKTCL patients
~To evaluate the long-term efficacy and safety of sintilimab combined with chidmide in the treatment of newly diagnosed ENKTCL patients.
~Exploring biomarkers that may have predictive effects."
15733830|NCT04994210|Drug|Chidamide|"To evaluate the short-term objective efficacy of sintilimab combined with chidamide in the treatment of newly diagnosed ENKTCL patients
~To evaluate the long-term efficacy and safety of sintilimab combined with chidmide in the treatment of newly diagnosed ENKTCL patients.
~Exploring biomarkers that may have predictive effects."
15733831|NCT04994197|Other|Observational study only - no intervention|Observational study only - no intervention
15733832|NCT04994158|Combination Product|Drugs, procedures|standard of care only. non interventional registry.
15733838|NCT04994119|Drug|BIA 5-1058|Oral BIA 5-1058 (Zamicastat) 100 mg tablets
15733839|NCT04994119|Drug|Warfarin|Oral Warfarin (Coumadin) 5 mg film coated tablets
15733840|NCT04994106|Drug|AZD5462|Participants will receive AZD5462, at dose levels of 1 to 5 in part A and at 1 to 4 in part B, respectively.
15733841|NCT04994106|Drug|Placebo|Participants will receive Placebo matched to AZD5462.
15733842|NCT04994093|Other|Collection of blood (PBMC), biopsy (FFPE) and stool samples.|Patients receiving routine treatment financed by the Polish National Health Fund (NFZ).
15733843|NCT04994080|Drug|Paricalcitol|Treatment group A: Paricalcitol 1μg QD Treatment group B: Paricalcitol 2μg TIW
15733844|NCT04994080|Drug|Placebo|Treatment group C: Placebo to match Paricalcitol，QD or TIW
15733845|NCT04994054|Dietary Supplement|silkworms (Bombyx mori L.) pupae extracts group|silkworms (Bombyx mori L.) pupae extracts 2,400 mg/day for 12 weeks
15733846|NCT04994054|Dietary Supplement|Placebo group|Placebo 2,400 mg/day for 12 weeks
15733847|NCT04994041|Other|Pelvic floor muscle plus adductor strengthening|20 sessions of pelvic floor muscle strengthening plus adductor is strengthening
15733848|NCT04994041|Other|Pelvic floor muscle exercises|20 sessions of pelvic floor muscle strengthening
15733849|NCT04994028|Other|Conventional treatment|Behavioral and life style modification and dyspnea prevention education i.e. Sitting: Sit upright with back against chair, feet wide apart, leaning forward with arms on bedside table or on knees. Standing: Lean back against wall with feet slightly apart with head and shoulder relaxed. In Bed: Elevate head of the bed, support and elevate arms with pillow. Stairs: Lean forward with on banister when climbing stairs.
15733850|NCT04994028|Other|conventional treatment with volume Spirometry and deep breathing|Group B or interventional group was received conventional treatment along with volume Spirometry and deep breathing exercise, total 5 breaths with 3sec inhalational breath hold for each breath at one session per day for volume Spirometry and for deep breathing exercise 10 times with breath hold 2sec at every session for 5 minutes 3 times per week for total duration of two weeks.
15747773|NCT04878003|Drug|KRT-232|KRT-232, administration by mouth
15733851|NCT04994015|Device|Lab Assay for seven genetic variants for Parkinson's Disease|Counseling provided to participant by site clinician/physician/genetic counselor.
15733852|NCT04994002|Drug|CERC-006|Oral solution
15733853|NCT04993989|Drug|Iberogast (STW5, BAY98-7411)|Survey without any intervention assigned in the study.
15733854|NCT04993976|Other|Resistant training (Prehabilitation)|Resistance training (10-15 repetitions: major muscle groups of upper and lower limbs [eg, shoulder overhead press, biceps curl, knee lift, and quadriceps extension in sitting and hamstrings curl exercises], one to three sets each) for 20-60 minutes five days a week.
15733855|NCT04993976|Other|Active Comparator: Control group|Conventional physiotherapy group followed basic pre-operative respiratory physiotherapy including deep breathing exercises, instructions in coughing techniques, mobilization, and active exercises of the upper limbs and thorax. Walk 30 m in the hospital ward.
15733856|NCT04993963|Other|Cycle Ergometery Training (Prehabilitation)|Interval training on cycle ergometer: between 40% and 60% Vo2max, perceived exertion <13 on Borg scale 20-30 min/session/day (intermittent of exercise 2-3 mint, followed by 1-2 min of active recovery) Cool down (5 minutes) AROM +Body stretch
15733857|NCT04993963|Other|Control Standard Group|Breathing exercise 15 Reps and Walk (10-15 minutes)
15733858|NCT04993950|Other|sustained natural apophyseal glides|SNAGS will be applied in flexion, extension and rotation for a few seconds with 3 repetitions on the first day and 10 repetitions from the next visit.
15733859|NCT04993950|Other|SNAGS with thoracic postural correction techniques|thoracic extension in sitting, Wall angle stretch and Corner stretch, while the therapist-facilitated stretches will be seated mid-thoracic stretch and prone mid thoracic stretch. Stretches will be maintained for 15-20 seconds with 10 repetitions of each stretch per session
15733860|NCT04993937|Other|Intervention|Interventional group will receive 6 weeks of plyometric training and receive training for week and three sessions in a week.
15733861|NCT04993937|Other|Control Group|Control group will follow their daily routine activities and may involve in any other exercise program rather than plyometric exercises.
15733862|NCT04993924|Drug|Cetrorelix Acetate, Ganerelix Acetate|3-6 days of 0.25 mg starting on day 2-3 of the menstrual cycle
15733867|NCT04993885|Drug|Avatrombopag|The subjects will receive avatrombopag treatment with an initial dose of 40mg once a day. Platelet counts will be obtained weekly during the first 4 weeks and then every 2 weeks until week 12 after treatment. The dose adjustment range is 20 mg per week to 40 mg per day to maintain the platelet level between 30×10^9/L and 200×10^9/L. If the platelet count does not reach to 30×10^9/L after taking avatrombopag 40mg once a day for 4 consecutive weeks, the treatment will be stopped.
15733868|NCT04993872|Drug|Biktarvy Tab|Multicenter Pilot study aiming to assess the safe use of BIC/FTC/TAF in HIV-KTR, using a single-arm design.
15733869|NCT04993859|Diagnostic Test|Non-invasive Urodynamic Test (niUDS)|A noninvasive urodynamics is a simple test used to evaluate urinary flow.
15733870|NCT04993859|Diagnostic Test|Urinary proteomic screen|Urine proteomics is a powerful platform to identify urinary excreted proteins and peptides in different stages of disease or therapy and to determine their quantity, functions, and interaction.
15733871|NCT04993859|Other|Dysfunctional Voiding Symptom Score Survey (DVSS)|The Dysfunctional Voiding Symptom Score provides accurate and objective grading of voiding behaviors of children.
15733872|NCT04993846|Diagnostic Test|Dental plaque sampling|Dental plaque sampling
15733873|NCT04993846|Diagnostic Test|qPCR|qPCR
15733874|NCT04993833|Device|NPi-200 and NPi-300 pupillometers|Device which measures PLR.
15733875|NCT04993820|Behavioral|Physical activity|The goal for week one will be to increase moderate-to-vigorous PA (MVPA) by 90 weekly/mins, and by 120 weekly/mins on week two. This amount of time will provide the participant with an adaptation period. The goal for weeks 3-12 will be to increase MVPA by at least 150 weekly/mins. The prescribed aerobic activities can be performed either: 1) outdoors (e.g., walking or cycling), 2) at home (e.g., in-place jogging, dancing, aerobics), or 3) with available exercise equipment if the participant already has this access. Participants will perform a series of 6 to 8 muscle strengthening (MS) exercises for the major muscle groups using elastic bands and their own bodyweight 3 times per week. All MS activities will be depicted in instructional videos available through the app. Participants will be asked to perform 2 sets of 8 to 12 repetitions (reps) per exercise during weeks 1-3, 3 sets of 8 to 12 reps per exercise during weeks 3-7, and 4 sets of 8 to 12 reps per exercise during weeks 8-12.
15733910|NCT04993586|Biological|AG0302-COVID19 for Intradermal Injection|Vaccination 1 mg of AG0302-COVID19 twice at 4-week intervals
15733876|NCT04993820|Behavioral|Education control|Participants in the education CON group will be asked to perform their usual activities and to not engage in additional PA during the intervention. Participants will receive weekly brochures and reading materials including topics related to living with HIV, healthy eating, stress management, and current Federal PA guidelines for Americans. The brochures and reading materials will be available through the BluejayEngage health web-based platform app.
15733877|NCT04993807|Other|Shared decision-making tool|Participants will use an interactive web page intended to aid patient decision-making (i.e., a decision aid) while undergoing consultation for atrial fibrillation ablation.
15733878|NCT04993794|Drug|XueBiJing Injection|XueBiJing, specification 10mL/ampule, packaging 10 ampules/container, concentration 0.1g/mL, were manufactured by a Good Manufacturing Practice certified company in China (Tianjin Chase Sun Pharmaceutical Co., Tianjin, China; China lot number 1304291, 1401091 and, 1501261). Generally, the treatment duration of the study was at least 5 days.
15733879|NCT04993794|Drug|Normal saline|Same saline dose as XueBiJing injection is taken intravenously.
15733880|NCT04993781|Behavioral|eSTEPS CDS|Primary care clinics at Brigham and Women's Hospital and Essentia Health will be randomized to receive the eSTEPS CDS or usual care
15733881|NCT04993768|Drug|TPN-101, 100 mg/day|100 mg/day of study investigational drug TPN-101 once daily for 24 weeks (double-blind treatment) followed by 400 mg/day TPN-101 for 24 weeks (open-label treatment).
15733882|NCT04993768|Drug|TPN-101, 200 mg/day|200 mg/day of study investigational drug TPN-101 once daily for 24 weeks (double-blind treatment) followed by 400 mg/day TPN-101 for 24 weeks (open-label treatment).
15733883|NCT04993768|Drug|TPN-101, 400 mg/day|400 mg/day of study investigational drug TPN-101 once daily for 24 weeks (double-blind treatment) followed by 400 mg/day TPN-101 for 24 weeks (open-label treatment).
15733884|NCT04993768|Drug|Placebo|Placebo once daily for 24 weeks (double-blind treatment) followed by 400 mg/day TPN-101 for 24 weeks (open-label treatment).
15733885|NCT04993755|Drug|TPN-101, 400 mg/day|400 mg/day of study investigational drug TPN-101 once daily for 24 weeks (double-blind treatment) followed by 400 mg/day TPN-101 for 24 weeks (open-label treatment).
15733886|NCT04993755|Drug|Placebo|Placebo once daily for 24 weeks (double-blind treatment) followed by 400 mg/day TPN-101 for 24 weeks (open-label treatment).
15733887|NCT04993742|Behavioral|MOMS Intervention|Behavioral: Mentors Offering Maternal Support (M-O-M-S) 10, 1 hour, structured classes meeting every-other-week in person beginning in the first trimester of pregnancy and unlimited access to mentor support.
15733888|NCT04993729|Drug|T89 capsule|"T89 capsule (trade name Dantonic®) is a botanical drug containing 75mg active substance which is the water extract of Danshen and Sanqi.
~T89 capsules, p.o. TID."
15733889|NCT04993729|Drug|Placebo capsule|Placebo capsules, p.o. TID.
15733890|NCT04993716|Other|observational|Collect from a bank of biological samples, identification of prognostic factors associated with survival without serious neurological heavy sequelae
15733891|NCT04993703|Other|Kinesiotaping|A total of 21 sessions physiotherapy sessions including hot pack, ultrasound therapy, transcutaneous electrical nerve stimulation (TENS), kinesiotaping and a home exercise program (tendon and nerve gliding, hand and wrist exercises=2 times per day 3sets of ten repetitions) will be applied.
15733892|NCT04993703|Other|Night Splinting|A total of 21 sessions physiotherapy sessions including hot pack, ultrasound therapy, transcutaneous electrical nerve stimulation (TENS), night splinting and a home exercise program (tendon and nerve gliding, hand and wrist exercises=2 times per day 3sets of ten repetitions) will be applied.
15733893|NCT04993703|Other|Control Group|A total of 21 sessions physiotherapy sessions including hot pack, ultrasound therapy, transcutaneous electrical nerve stimulation (TENS) and a home exercise program (tendon and nerve gliding, hand and wrist exercises=2 times per day 3sets of ten repetitions) will be applied.
15733894|NCT04993690|Drug|LP-168 tablet|Subjects to take LP-168 orally with 240mL water, without food, Once daily or twice daily
15733899|NCT04993664|Drug|Pelacarsen (TQJ230)|The first group will receive pelacarsen. Blood samples from all patients will be drawn for laboratory measurements and genetics determination. Ultrasound measurement of endothelium-dependent dilatation of the brachial artery and beta stiffness of carotid arteries will be measured.
15733900|NCT04993664|Drug|Placebo|The second group will receive placebo. Blood samples from all patients will be drawn for laboratory measurements and genetics determination. Ultrasound measurement of endothelium-dependent dilatation of the brachial artery and beta stiffness of carotid arteries will be measured.
15733901|NCT04993651|Device|CPAP|CPAP is a form of noninvasive positive pressure ventilation (NPPV). CPAP works to maintain adequate levels of PO2 and PCO2 through improved alveolar ventilation and maintenance of upper-airway patency.
15733902|NCT04993638|Device|hip arthroplasty|Hip prosthesis surgery
15733903|NCT04993625|Procedure|avoid axillary sentinel lymph node biopsy after neoadjuvant chemotherapy|Selective Omission of Sentinel Lymph Node Biopsy after Neoadjuvant Chemotherapy In HER-2 positive/Triple Negative Breast Cancer Patients with Excellent Radiologic Response to the Breast and Axilla
15733904|NCT04993612|Diagnostic Test|Blood gas analysis|"Two blood samples will be drawn from the wedge position, behind the inflated balloon, during the right heart catheterization, and blood gas analyses will be performed. First sample will be drawn directly after inflating the ballon, and the second one 2 minutes later."
15733905|NCT04993599|Device|Social robot interaction|The participants interact with the social robot which is controlled by the researcher behind the scene (wizard of oz. method).
15733906|NCT04993586|Biological|AG0302-COVID19 for Intramuscular Injection|Vaccination 2 mg of AG0302-COVID19 three times at 2-week intervals
15733907|NCT04993586|Biological|AG0302-COVID19 for Intramuscular Injection|Vaccination 4 mg of AG0302-COVID19 twice at 4-week intervals
15733908|NCT04993586|Biological|AG0302-COVID19 for Intramuscular Injection|Vaccination 8 mg of AG0302-COVID19 twice at 4-week intervals
15733909|NCT04993586|Biological|AG0302-COVID19 for Intradermal Injection|Vaccination 1 mg of AG0302-COVID19 three times at 2-week intervals
15733911|NCT04993573|Other|Questionnaire|Questions about the impact of COVID-19 in their works
15733912|NCT04993573|Other|Individual interview|Discussion between the searcher and the participant about representations of COVID-19 and experiences about confinement.
15733915|NCT04993547|Other|Parent and peer presence|Does the presence of fellow pupils and parents improves a pupil's resistance to undergo a nasopharyngeaal swab test?
15733916|NCT04993534|Behavioral|Stepped-care DWM/PM+|"The DWM program consists of a self-help guide that is complemented with pre-recorded audio exercises. The audio material imparts key information about stress management and guides participants through individual exercises. Additionally, participants are guided by a briefly trained helper. DWM includes five sections (or modules), each of which focuses on a specific skill. In this study, the DWM program will be delivered as an online intervention. The DWM intervention, i.e. both the audios and the self-help guide, have been adapted for use on a smartphone or other device with internet access.
~PM+ is a new, brief, psychological intervention program based on cognitive-behavioral therapy (CBT) techniques. The manual involves the following empirically supported elements: problem solving plus stress management, behavioral activation, facing fears, and accessing social support."
15733917|NCT04993534|Other|Psychological First Aid + usual care (CAU)|All participants, both in the treatment and the comparison group, will be offered individual Psychological First Aid (PFA) through a face-to-face or teleconferencing meeting. In addition to PFA, both the treatment and the comparison group will receive care-as-usual (CAU); they will be allowed to receive any usual care. CAU may include community care, social/legal support, and psychoeducation.
15733918|NCT04993521|Procedure|Block type|Regular block type
15733919|NCT04993508|Diagnostic Test|PSA test|testing for blood levels of PSA
15733920|NCT04993508|Device|multiparametric prostate Magnetic Resonance Imaging (mpMRI)|mpMRI acquisition and reporting will be performed according to the current version of the Prostate Imaging-Reporting and Data System (PI-RADS). MpMRI will be performed at the different study centers on a 3 Tesla MR scanner using multi-phased array surface coil. MpMRI includes T1-weighted and T2-weighted imaging (T1WI, T2WI), diffusion-weighted imaging (DWI), and dynamic contrast-enhanced imaging (DCE-MRI). Hyoscine butyl bromide will be administered to optimize image quality. Prostate imaging quality will be assessed by the prostate imaging quality score (PI-QUAL). In case of contraindications to MRI contrast agents, DCE will be omitted. In case of contraindications to hyoscine butyl bromide, it will be omitted. Lesions with a PI-RADS score of ≥ 4 and 3 with PSAD > 0.15 will considered suspicious for csPCa.
15733921|NCT04993508|Procedure|targeted MRI/US fusion-guided biopsy|Targeted MRI/US fusion-guided biopsy (TB) are performed using transrectal ultrasound (max. 6 cores from 3 targets). MRI/US fusion-guided biopsies can be performed transrectally or transperineally. Ultrasound-guided biopsies will be performed with a 3-D probe and with local or general anesthesia. Coverage with antibiotics has to be provided as per local standard of care for all biopsies.
15733922|NCT04993508|Procedure|combined prostate biopsy (systematic biopsy plus targeted MRI/US fusion-guided biopsy)|The combined biopsy comprises systematic biopsy (SB) and targeted MRI/US fusion-guided biopsy (TB). They are performed using transrectal ultrasound (number of cores: SB 12 cores, TB max. 6 cores from 3 targets). MRI/US fusion-guided biopsies can be performed transrectally or transperineally. Ultrasound-guided biopsies will be performed with a 3-D probe and with local or general anesthesia. Coverage with antibiotics has to be provided as per local standard of care for all biopsies.
15733923|NCT04993508|Procedure|MRI inbore biopsy|MRI inbore biopsies will be offered after negative initial MRI/US fusion-guided biopsy or diagnosis of only clinically insignificant PCa in initial biopsy in arms A or B. Before performing MRI inbore biopsy the PI-RADS scoring will be re-confirmed. The number of cores will be 2 per target. In case of inaccurate needle position additional cores are allowed to ensure correct targeting. Needle position will be verified in 2 planes. Coverage with antibiotics has to be provided as per local standard of care.
15733924|NCT04993482|Other|No intervention|This project contains a longitudinal observational study design. The investigator will collect data out of a group with type 2 diabetes mellitus patients and out of group with control adults on three time points (baseline, follow-up after one year, and follow-up after two years). Therefore, the investigator will only collect observational data and the participants will not be exposed to a certain intervention.
15733925|NCT04993469|Diagnostic Test|Semmes-Weinstein monofilament testing and questionnaires|Semmes-Weinstein test for the assessment of genital sensation Battery of questionnaires assessing sexual function, voiding function, quality of life and patient satisfaction
15733926|NCT04993456|Procedure|Caridac surgery|Cardiac surgery
15733927|NCT04993443|Drug|LQ036|For Each part of the study, a staggered dosing schedule may be used for the first dose level, in each cohort including 2 sentinel subjects (1 active and 1 placebo) initiating dosing first and the remaining 6 subjects initiating dosing no sooner than the next day. Cohorts will be dosed sequentially in an ascending fashion. Each study part (A, B and C) will be completed sequentially, but with partial overlapping. Part B and C may only be initiated after review of the safety, tolerability, and PK data following dosing of the SAD Cohort 3 or 4.
15733928|NCT04993443|Other|Matching Placebo|Matching Placebo for LQ036: Matching Placebo
15733929|NCT04993430|Drug|HRS8807|HRS8807 monotherapy
15733930|NCT04993430|Drug|HRS8807|HRS8807 monotherapy
15733931|NCT04993430|Device|HRS8807、SHR6390|HRS8807 in combination with SHR6390
15733932|NCT04993430|Drug|HRS8807、SHR6390|HRS8807 in combination with SHR6390
15733933|NCT04993417|Other|Motor imagery technique along with EMS|All the subjects carried out the treatment process for a total of 3 months. During this treatment duration, the sessions were administered 3 times per week for 45 minutes, depending upon the subject's ability to focus and tiredness. The patients were mentioned to play out the emotional facial appearances for non-verbal correspondence i-e pleasure, misery, interest, appall, dread, irritation and shock. Patients were then requestedto envision himself winking, for instance, envisioning himself in a wonderful and natural social setting, at that point the patient cognitively addresses, with his eyes shut, the movement of decaying the recognized central issues, without creating any specific movement.
15733974|NCT04993209|Biological|NDV-HXP-S parental vaccine simple dose (Group B1d) - 60 years old or more|Stage B - 60 years old or more
15733975|NCT04993209|Biological|Active vaccine control simple dose (Group B1d)|Stage B - 60 years old or more
15733934|NCT04993417|Other|Mime Therapy along with EMS|All the subjects carried out the treatment process for a total of 3 months. During this treatment duration, the sessions were administered 3 times per week for 45 minutes, depending upon the subject's ability to focus and tiredness. Mime treatment incorporates self kneading of face and neck, breathing and relaxation works out, activities to synchronize the two sides and diminish synkinesis and for eye and lip closure per the myofascial way to deal with recovery, letter and word practices and expressive activities.
15733935|NCT04993404|Drug|Jaktinib Hydrochloride Tablets|A single oral dose of 100 mg Jaktinib Hydrochloride Tablets will be administered.
15733936|NCT04993391|Drug|JS111(AP-L1898 Capsules)|40 mg, QD
15733937|NCT04993391|Drug|JS111(AP-L1898 Capsules)|80 mg, QD
15733938|NCT04993391|Drug|JS111(AP-L1898 Capsules)|160 mg, QD
15733939|NCT04993391|Drug|JS111(AP-L1898 Capsules)|240 mg, QD
15733940|NCT04993391|Drug|JS111(AP-L1898 Capsules)|320 mg, QD
15733941|NCT04993378|Device|EV-array|"Collect peripheral blood sample of 40 gastric cancer patients pre-treatment. Blood samples will be transferred to central lab to detect EV-score by EV-array. Tumor response evaluation will be performed after two cycles of chemotherapy by CT/MRI based on RECIST.
~Clinical data, including tumor stage, metastastic organ, regimen, objective response, progression free survival, overall survival, etc, will be collected according to study protocol."
15733942|NCT04993365|Biological|Experimental Group1|The COVID-19 vaccine was manufactured by Sinovac Research & Development Co., Ltd,and the quadrivalent influenza vaccine and the 23-valent pneumococcal polysaccharide vaccine(PPV23) were manufactured by Sinovac Biotech Co. The COVID-19 vaccine:600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection;The quadrivalent influenza vaccine:15ug hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection;PPV23:capsular polysaccharides of 23 serotypes of pneumococcus in 0.5 mL of Sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.
15733943|NCT04993365|Biological|Experimental Group 2|The COVID-19 vaccine was manufactured by Sinovac Research & Development Co., Ltd,600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
15733944|NCT04993365|Biological|Experimental Group 3|The quadrivalent influenza vaccine and the 23-valent pneumococcal polysaccharide vaccine(PPV23) were manufactured by Sinovac Biotech Co,the quadrivalent influenza vaccine:15ug hemagglutinin (HA) of each of the four influenza strains in 0.5 mL of sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection;PPV23:capsular polysaccharides of 23 serotypes of pneumococcus in 0.5 mL of Sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate per injection.
15733945|NCT04993352|Drug|recombinant anti-vascular endothelial growth factor (VEGF) humanized monoclonal antibody ophthalmic injection|0.05mL (12.5mg/0.5mL/vial) HLX-04-O solution at a 4-week interval for intravitreal injection
15733946|NCT04993339|Drug|OOC|The OOC will be mixed with autologous 5cc of platelet rich plasma (PRP), and then injected using a syringe into both tibia and femoral tunnels
15733947|NCT04993326|Behavioral|emPOWERed To Change Program|Online Diabetes Self-Management Education and Support along with COVID-19 prevention and protection (vaccination) education and resource information
15733948|NCT04993313|Other|Counseling|Undergo verbal counseling
15733949|NCT04993313|Other|Educational Intervention|View photo guide
15733950|NCT04993313|Behavioral|Questionnaire|Complete questionnaires
15733951|NCT04993300|Device|transcranial magnetic stimulation (TMS)|The methamphetamine user will undergo a one-month TMS intervention. In Week 1, subjects will attend continuously 5 daily TMS sessions. From Week 2 to Week 4, subjects are treated once a week. Each session will have 40 repeats of 4-second train and 15-sec train interval.
15733952|NCT04993287|Other|Non-invasive continuous remote monitoring with structured escalation pathway|Continuous patient monitoring through non-invasive biosensors coupled with machine learning algorithms, with a structured escalation and communication pathway for home health providers and HF care team
15733953|NCT04993287|Other|Affective Analysis of Participant Response to Continuous Remote Patient Monitoring|Surveys and interviews with enrolled participants
15733954|NCT04993274|Diagnostic Test|PASS-MS|protocol using short motor tasks performed by the subject and recorded by a depth camera, motion analysis by visuo-perceptive computing
15733955|NCT04993261|Procedure|Dual-Energy Computed Tomography|Undergo dual energy CT scan
15733956|NCT04993248|Other|Dialog Circle|"The intervention will offer participants the opportunity to share feelings and needs with people who are in a similar situation to their own.
~Each intervention consists of 3 dialogue circles per group. Each group is composed of 10 participants and a facilitator, in all interventions the facilitator will be the principal investigator."
15733957|NCT04993235|Behavioral|NEPSY-II|Participants with SS and BWS are administered with selected subtests assessing six different neuropsychological domains
15733958|NCT04993235|Behavioral|CBCL and AQ questionnaires|Parents of participants with SS and BWS are administered with questionnaires assessing behavioral problems and autistic traits
15733959|NCT04993235|Behavioral|BUT questionnaire and experimental tasks|A questionnaire, a computer-based task, a body-illusion paradigm and two psychophysical tasks assessing diverse levels of body perception and representation. These tasks are administered to adolescents of the three groups
15733960|NCT04993222|Drug|Amphotericin B liposome for injection|IV infusion
15733961|NCT04993222|Drug|AmBisome®|IV infusion
15733962|NCT04993209|Biological|NDV-HXP-S 1μg (Stage A)|Stage A
15733963|NCT04993209|Biological|NDV-HXP-S 3μg (Stage A)|Step A
15733964|NCT04993209|Biological|NDV-HXP-S 10μg (Stage A)|Stage A
15733965|NCT04993209|Biological|NDV-HXP-S parental vaccine in 3 consecutive lots (Group B1a)|Stage B
15733966|NCT04993209|Biological|Active vaccine control (Group B1a)|Stage B
15733967|NCT04993209|Biological|NDV-HXP-S parental vaccine (Group B1b)|Stage B
15733968|NCT04993209|Biological|Active vaccine control (Group B1b)|Stage B
15733969|NCT04993209|Biological|NDV-HXP-S parental vaccine (Group B1c)|Stage B
15733970|NCT04993209|Biological|Active vaccine control (Group B1c)|Stage B
15733971|NCT04993209|Other|Placebo (Stage A)|Placebo as a control (Stage A).
15733972|NCT04993209|Biological|NDV-HXP-S parental vaccine simple dose (Group B1d)|Stage B.
15733973|NCT04993209|Biological|Active vaccine control (Group B1d)|Stage B
15733976|NCT04993209|Biological|NDV-HXP-S P.1 vaccine (Group B1e)|Stage B
15733978|NCT04993209|Biological|NDV-HXP-S vaccine based in variant / 3 consecutive lots (Group C1a)|Stage C
15733979|NCT04993209|Biological|NDV-HXP-S vaccine based in variant (Group C1b)|Stage C
15733980|NCT04993209|Biological|NDV-HXP-S vaccine based in variant (Group C1c)|Stage C
15733981|NCT04993209|Biological|NDV-HXP-S vaccine based in variant (Group C1c) - 60 years old or more|Stage C - 60 years old or more
15733982|NCT04993209|Biological|NDV-HXP-S P.1 vaccine (Group B2a)|Stage B
15733983|NCT04993209|Biological|NDV-HXP-S P.1.351 vaccine (Group B2a)|Stage B
15733984|NCT04993209|Biological|NDV-HXP-S vaccine based in variant / 3 consecutive lots (Group C2a)|Stage C
15733985|NCT04993209|Biological|Active vaccine control (Group C2a)|Stage C
15733986|NCT04993209|Biological|NDV-HXP-S vaccine based in variant (Group C2b)|Stage C
15733987|NCT04993209|Biological|Active vaccine control (Group C2b)|Stage C
15733988|NCT04993209|Biological|NDV-HXP-S vaccine based in variant (Group C2c)|Stage C
15733989|NCT04993209|Biological|Active vaccine control (Group C2c)|Stage C
15733990|NCT04993209|Biological|NDV-HXP-S parental vaccine simple dose (Group C2d)|Stage C
15733991|NCT04993209|Biological|Active vaccine control simple dose (Group C2d)|Stage C
15733992|NCT04993209|Biological|NDV-HXP-S parental vaccine simple dose (Group C2d) - 60 years old or more|Stage C - 60 years old or more
15733993|NCT04993209|Biological|Active vaccine control simple dose (Group C2d) - 60 years old or more|Stage C - 60 years old or more
15733994|NCT04993196|Diagnostic Test|T1rho imaging|Magnetic Resonance Imaging using T1rho
15733995|NCT04993183|Behavioral|3-day PLUS Convention|Participants will participate in a 3-day PLUS Convention, comprising an inclusivity education workshop, a service-learning seminar, a disability simulation workshop, and two community contact sessions which will consist of a 60-minute interview with an older adult with a physical disability and an outdoor experience. Discussion sessions will be facilitated throughout to consolidate learning.
15733996|NCT04993170|Diagnostic Test|Bleeding assessment tool|The standardized application of the questionnaire serves to identify patients at risk of bleeding at an early stage and to adapt and optimize perioperative coagulation management accordingly by initiating targeted diagnostics and therapy
15733997|NCT04993157|Drug|FIA586|FIA586 capsule
15733998|NCT04993144|Device|continuous theta burst stimulation|stimulatory protocol
15733999|NCT04993131|Procedure|Liver transplant|Liver transplant.
15734000|NCT04993118|Other|Integrated Neuromuscular Inhibition technique|Integrated Neuromuscular inhibition technique At first ischemic compression was given using a pincer grip over the active trigger point till the tissue barrier was felt .The process was repeated till the tension reduced for 90 seconds.Ischemic compression was followed by the application of strain counterstrain. Once the position of ease was identiﬁed, it was held for 90 seconds and repeated for three to ﬁve repetitions. Muscle energy technique was applied as last part of integrated neuromuscular inhibition technique . Each isometric contraction was held for 7-10 seconds and was followed by further contralateral side bending, ﬂexion, and ipsilateral rotation to maintain the soft tissue stretch. Each stretch was held for 30 seconds and was repeated three to ﬁve times per treatment session
15734001|NCT04993118|Other|Ischemic Compression,Hotpack,TENS|Control group received conventional physical therapy. It included HOT Packs ( 20 minutes) , TENS (10 minutes) ,Ischemic compression .Using a pincer grasp, we identified the trigger point. Once the trigger point was identiﬁed we applied ischemic compression by placing the thumb and index ﬁnger over the active TrP. Slow, increasing levels of pressure was applied until the tissue resistance barrier was identiﬁed. Pressure was maintained until a release of the tissue barrier was felt. At that time, pressure was again applied until a new barrier was felt. This process was repeated until tension/tenderness is unable to be identiﬁed
15734002|NCT04993105|Other|Exercise + Graston.|"In graston + exercises treatment will be same but after exercises added with proper application of graston which included application of a cream to the posterior calf and plantar foot from the knee to the toes to reduce friction on the skin.The Graston tools will be then used to mobilize the tissues of the triceps surae and plantar foot. In areas of increased tissue restriction, more aggressive pressure with graston was applied using increased force and shorter strokes over the areas of restrictionIce was offered as needed for pain management after each session. This will be continued for three sessions. NPRS score, score on FADI and dorsiflexors range will be assessed after treatment of two weeks. Along with conventional treatment.
~."
15734003|NCT04993105|Other|exercise only|gastrocnemius and plantarstretching
15734004|NCT04993092|Other|muscle energy technique|Post facilitation stretch Patient perform isometrics for 15 seconds then therapist rapidly move the shoulder to the end range
15734005|NCT04993092|Other|mulligan mobilization technique|Sustain Posterolateral glide with belt and then told Patient to move in following pattern (internal rotation, external rotation, abduction, wall sliding)
15734006|NCT04993079|Device|Clotild®|Use of Clotild® as neurovascular guidewire
15734007|NCT04993066|Device|GentleMax Pro Plus|The GentleMax Pro Plus laser system to be used in this study received 510(k) market clearance from the U.S. Food and Drug Administration (FDA) under K201111 on May 26, 2020
15734008|NCT04993040|Drug|Oraxol|"HM30181 methanesulfonate monohydrate
~Oral paclitaxel capsules"
15734009|NCT04993027|Drug|Vancomycin Powder|Vancomycin is a bactericidal aminoglycoside antibiotic which inhibits cell wall synthesis. It is effective against gram positive bacteria. Though most commonly administered intravenously, it can be delivered orally or directly into surgical incisions and wounds in certain indications.
15734010|NCT04993014|Drug|Pertuzumab|Adjuvant trastuzumab + pertuzumab (arm B of the 2 cohorts: 1: HER2 positive CTCs at baseline and 2: HER2 negative/absent CTCs at baseline)
15734011|NCT04993014|Drug|Trastuzumab|Adjuvant trastuzumab (arm A of the 2 cohorts: 1: HER2 positive CTCs at baseline and 2: HER2 negative/absent CTCs at baseline) Association with pertuzumab in arm B of the 2 cohorts
15734012|NCT04993014|Other|Circulating tumor cells|Blood sample collection for examination of CTCs at baseline of neoadjuvant therapy. Tests for HER2 positivity will be done.
15734039|NCT04992741|Other|education and motivational interview|The control group will remain subject to the routine process without any intervention.
15734067|NCT04992507|Drug|General Anesthesia Procedure|Given inhaled volatile anesthetics
15734068|NCT04992507|Procedure|Resection|Undergo surgical resection
15747774|NCT04878003|Drug|TL-895|TL-895, administration by mouth
15734015|NCT04992988|Drug|Toripalimab|Toripalimab 240mg every 3 weeks with a total of 3 cycles as concurrent anti-PD-1 immunotherapy; Toripalimab240mg every 3 weeks with a total of 9 cycles as adjuvant anti-PD-1 immunotherapy 2 weeks after CCRT
15734016|NCT04992975|Other|MRI at 7T|MRI at 7T
15734017|NCT04992962|Drug|CBD/CBN|A water-soluble sublingual tablet containing 10 mg of CBD and 10 mg of CBN.
15734018|NCT04992962|Drug|CBD/THC|A water-soluble sublingual tablet containing 10 mg of CBD and 5 mg of THC.
15734019|NCT04992962|Drug|Placebo|An inactive compound.
15734020|NCT04992949|Drug|CPX-351|"Induction : patients will receive induction treatment with CPX-351 100 U/m2 on days 1, 3, and 5. Patients who fail to achieve CR/CRi after the induction cycle will be offered a second induction course of CPX-351 100 U/m2 on days 1 and 3, at the investigators' discretion. If CR/CRi is not achieved following the second induction cycle, patients will go off study
~Consolidation : patients in CR/CRi after induction cycle will receive up to 2 course of consolidation therapy with CPX-351 65 U/m2 on days 1 and 3. CPX351 doses could be reduced to 65 U/m2 on day 1 in case of unacceptable toxicity following the previous course.
~Allo-SCT : patients for whom an allo-SCT is planned will receive a maximum of one consolidation cycle"
15734021|NCT04992936|Dietary Supplement|Dry wine from the lees of Cabernet variety (VLC)|The product will be presented in powder format in a single container and with a measuring spoon of the daily dose.
15734022|NCT04992936|Dietary Supplement|Placebo|The product will be presented in powder format in a single container and with a measuring spoon of the daily dose.
15734023|NCT04992910|Device|Functional electrical stimulation through medical device|"The patient will receive in addition to conventional therapy offered in the usual clinical practice of the Hospital, a therapy with functional electrical stimulation. For this, a device called Fesia Grasp will be used.
~Duration: 180 min a week spread over 3 alternate days, for 6 weeks."
15734024|NCT04992910|Other|Standard therapy|Physical and occupational therapy applied to the subject. Duration: 180 min a week spread over 3 alternate days, for 6 weeks.
15734025|NCT04992897|Device|Remote Electrical Neuromodulation (REN)|Acute migraine treament
15734027|NCT04992858|Drug|CT053PTSA|CT053PTSA will be administered orally once a day
15734028|NCT04992845|Device|Anterior Vertebral Body Tethering|The SCOLI-TETHER (MIScoli) System is intended for anterolateral vertebral body fixation and internal fastening of the convex side of the thoracic curvatures thereby reducing the deformity and preventing the progression of idiopathic scoliosis in growing children/adolescents at high risk for curve progression while preserving motion.
15734029|NCT04992832|Biological|human umbilical cord mesenchymal stem cells|Human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group.
15734030|NCT04992832|Other|human serum albumin|Saline solution containing 1 percent human serum albumin will be infused to the control group.
15734031|NCT04992819|Procedure|Chronobiological Approach Nutrition Model|In the intervention group, a label containing the time of expressed breastmilk will be affixed. In the milk preparation room, breast milk will be stored in a separate refrigerator as 08:00-19:59 day milk and 20:00-07:59 night milk.
15734032|NCT04992806|Procedure|hip arthroscopy|Use epidural anesthesia or general anesthesia. The patient lies on the orthopedic traction bed to protect the perineum and perform traction of the lower limbs on the surgical side. Under arthroscopy, check the labrum, acetabular articular surface and femoral head cartilage, and round ligament in turn. The acetabular labrum with tear degeneration was treated with labrum suture or labrum revision surgery according to the injury. Perform femoral head and neck plastic or acetabular plastic surgery, osteoid osteoma debridement, etc.
15734033|NCT04992793|Combination Product|Congenital heart surgery|Paediatric congenital heart surgery
15734034|NCT04992780|Radiation|Hypo-Fractionation|62.5 Gy in 25 fractions of 2.5 Gy/fraction
15734035|NCT04992780|Radiation|Standard-Fractionation|60 Gy in 30 fractions of 2 Gy/fraction
15734036|NCT04992767|Behavioral|Sunnyside|The Sunnyside intervention is an online intervention(an interactive website with didactic material and interactive tools) targeting skills to manage mood during and after pregnancy. The Sunnyside intervention will consist of 6 weeks of online lessons during pregnancy and booster sessions at 2 weeks, 4 weeks, and 6 weeks postpartum. Each lesson takes approximately 10 minutes to complete.
15734037|NCT04992767|Behavioral|Sunnyside Flex|Sunnyside Flex consists of 8 weeks of online lessons during pregnancy and booster sessions at 2 weeks, 4 weeks, and 6 weeks postpartum. Sunnyside Flex builds upon the same Sunnyside intervention by providing the original 6-week Sunnyside program (described above), followed by an additional 2 weeks of trauma-specific prenatal intervention designed to reduce symptoms of PTSD, using evidence-based content that has been tailored specifically to the perinatal period.
15734038|NCT04992754|Behavioral|psychotherapy, lifestyle counseling|psychotherapy, lifestyle counseling
15734040|NCT04992728|Other|Restricted Spectrum Magnetic Resonance Imagining|Restriction Spectrum Magnetic Resonance Imaging (RS-MRI), which uses magnetism instead of x-rays to build up a picture of the inside of the body. The scan is completely painless but can be rather noisy and requires the patient to lie very still inside the center of a large, doughnut-shaped magnet for approximately 30-60 minutes complete the imaging.
15734041|NCT04992715|Diagnostic Test|[99mTc]-NM01 SPECT/CT|Technetium-99m radiolabelled anti-PD-L1 single-domain antibody (NM01) single-photon emission computed tomography (SPECT)/computed tomography (CT)
15734042|NCT04992702|Behavioral|Animated Video|Animated video to improve learning and motivation
15734043|NCT04992676|Diagnostic Test|Polysomnograpy|Home polysomnography will be conducted using the scalable, modular Embletta system. Trained staff will instrument the participants in the evening and perform biocalibration to ensure optimal data quality
15734044|NCT04992676|Diagnostic Test|actigraphy|A water resistant accelerometer with light sensor and event marker will be worn on the nondominant wrist for approximately 7 days. Activity counts from the device will be analyzed by proprietary software algorithms for determination of the following: sleep onset, sleep offset, total sleep time, total wake time, and sleep efficiency.16 Daytime sleep periods will be also scored to determine frequency and duration of naps. Daily data will be averaged across the 7-day period, as well as separately for weekdays and weekend, to compute measures of habitual sleep patterns.
15734045|NCT04992663|Device|PICO glasses and controller with BirthVR|"PICO glasses will be used for VR in the intervention group. BirthVR is a guided meditation VR application designed by qualitative research (VIREL study) performed by this study group.
~The BirthVR application contains the following components:
~Information/introduction video (including a virtual reality tour through the labour ward of the Zuyderland MC)
~Fase 1: Beach environment, guided meditation/breathing exercise (1 session: 25 minutes)
~Fase 2: Underwater environment, guided meditation/breathing exercise (1 session: 25minutes)
~Fase 3: Mountain environment, breathing technique exercise on demand by using the controller (1 session: 30 minutes)
~Counseling video (cesarean section, epidural anesthesia)"
15734046|NCT04992650|Procedure|Fat grafting|Fat grafting
15734047|NCT04992637|Behavioral|ClockWork|ClockWork is a behavioral weight loss intervention comprised of coaching sessions as well as digital monitoring and feedback tools. It addresses 4 key behaviors related to the CTS, weight, and health and their Amount, Regularity & Timing-the ART of ClockWork. Women will receive 12 tailored coaching sessions to review their digital monitoring of each key behavior, learn intervention content, and set goals, which are delivered in-person, by phone, or web to fit women's needs postpartum. Coaches will use women's baseline responses to tailor sessions around the key behaviors. The investigators will protocolize real-time monitoring to increase engagement and adherence, and to facilitate just-in-time adaptive reminders, recommendations, and coaching sessions.
15734048|NCT04992637|Other|Usual Care|Usual Care consists of an e-newsletter on maternal health, postpartum weight loss, and general calorie guidelines for lactating/nonlactating women.
15734049|NCT04992624|Drug|Placebo|"Placebo drug will be taken similarly to the THC and CBD and be matched to keep the trial blinded.
~Participants will be instructed to eat a meal or snack greater than one hour after taking study drug."
15734050|NCT04992624|Drug|Cannabidiol (CBD)|"Epidiolex doses will be 0.37 milliliter (mL) for seven days of treatment and then 0.75 mL two times a day (b.i.d) for the remaining days of this treatment.
~Participants will be instructed to eat a meal or snack greater than one hour after taking study drug."
15734051|NCT04992624|Drug|Tetrahydrocannabinol (Marinol® or generic equivalent (e.g., dronabinol)|"Dronabinol Capsules doses will be 2.5 mg b.i.d. for seven days of treatment and then 5 mg b.i.d. for the remaining days of this treatment.
~Participants will be instructed to eat a meal or snack greater than one hour after taking study drug."
15734052|NCT04992611|Behavioral|Sleep Extension (Early)|Following a periods of time meant to stabilize their sleep patterns and to induce mild sleep restriction, participants will be randomly assigned to one of two sleep extension conditions, both of which are designed to allow recommended sleep duration. The Early Sleep Extension condition does so by keeping rise time the same as the sleep restriction period, but extending sleep by going to bed earlier. This produces a sleep extension that is aligned for Morning Larks and misaligned for Night Owls.
15734053|NCT04992611|Behavioral|Sleep Extension (Late)|Following a periods of time meant to stabilize their sleep patterns and to induce mild sleep restriction, participants will be randomly assigned to one of two sleep extension conditions, both of which are designed to allow recommended sleep duration. The Early Sleep Extension condition does so by keeping bedtime the same as the sleep restriction period, but extending sleep by rising later. This produces a sleep extension that is misaligned for Morning Larks and aligned for Night Owls.
15734056|NCT04992585|Device|Percutaneous transhepatic implantation of self-expandable metal stent|A self-expandable metal stent is inserted into the extrahepatic bile duct which is obstructed by malignant disease
15734057|NCT04992572|Drug|Propofol Injection|25mg Propofol administered by injection
15734058|NCT04992572|Drug|Lidocaine Hydrochloride, Injectable|Licocaine administered locally via injection.
15734059|NCT04992559|Drug|Consolidation Toripalimab|Toripalimab consolidation therapy after radiotherapy or chemoradiotherapy, 240mg IV, every 3 weeks, until progressive disease (PD), start new anti-cancer therapy, intolerable toxicity, withdraw informed consent or other conditions that require study treatment discontinuation. Toripalimab will be given at a maximum of 12 months.
15734060|NCT04992546|Drug|PRN473 (SAR444727)|White to off-white gel suspension
15734061|NCT04992546|Drug|Placebo|White to off-white gel suspension
15734062|NCT04992533|Procedure|Long-duration tourniquet|Tourniquet is used in arthroscopic exploration and high tibial osteotomy
15734063|NCT04992533|Procedure|Short-duration tourniquet|Tourniquet is only used for arthroscopic exploration
15734064|NCT04992520|Biological|S. sonnei 53G|Shigella sonnei strain 53G (Lot 1794) Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast
15734065|NCT04992520|Biological|S. flexneri 2a 2457T|Shigella flexneri strain 2457T (Lot 1617) Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast.
15734066|NCT04992507|Procedure|Anesthesia Procedure|Given TIVA
15747775|NCT04877990|Drug|BMS-986165|Specified dose on specified days
15734069|NCT04992494|Behavioral|MBCT-Telephone|"Mindfulness-based cognitive therapy (MBCT) comprised of 8 weekly classes delivered via telephone by a licensed clinical psychologist certified to teach MBCT, following treatment fidelity guidelines from NIH's Behavioral Change Consortium.
~The program involves a commitment of 1 hour per week for 8 weeks. During the sessions, subjects will learn cognitive and mindfulness skills to help manage and cope with depression. Each weekly session consists of: check-in, instruction, skill building, discussion, and a home-based practice assignment."
15734070|NCT04992494|Behavioral|MBCT-Video|"Mindfulness-based cognitive therapy (MBCT) comprised of 8 weekly classes delivered via WebEx video-conferencing by a licensed clinical psychologist certified to teach MBCT, following treatment fidelity guidelines from NIH's Behavioral Change Consortium.
~The program involves a commitment of 1 hour per week for 8 weeks. During the sessions, subjects will learn cognitive and mindfulness skills to help manage and cope with depression. Each weekly session consists of: check-in, instruction, skill building, discussion, and a home-based practice assignment."
15734071|NCT04992481|Procedure|PMTC|In patients from the study groups I, II, III, IV a professional mechanical tooth cleaning (PMTC) including air-polishing was proceeded on every visit using a glycine-based prophylaxis powder (Air-Flow Soft, EMS, Switzerland).
15734072|NCT04992481|Procedure|fluoride varnish|In patients from groups I, II, III, IV a fluoride varnish of 5% NaF (Profluorid Varnish, Voco, Germany) was applied with a microbrush. Every patient was instructed to stop from drinking and eating for the next two hours (as recommended by the manufacturer).
15734073|NCT04992481|Procedure|gaseous ozone therapy|Patients from groups II and IV were additionally subjected to in-office ozone therapy using OzonyTron-OZ (Mymed, Germany). Ozone was applied on a silicone double-jaw tray of a proper size (allowing even ozone distribution in the oral cavity) following professional mechanical tooth cleaning. A Full Mouth Desinfection program lasting 5 minutes was used.
15734074|NCT04992481|Procedure|domestic octenidin mouth rinse|Patients from groups III and IV received a domestic mouthrinse (Octenidol MD, Schülke, Germany) and were recommended to use 15 ml of the liquid for 30 seconds after evening toothbrushing.
15734075|NCT04992468|Drug|Ovulation triggering with GnRH-a+rhCG|recombinant follicle stimulating hormone (rFSH) 225-300 IU (Gonal-F®/Puregon®/ Ovaleap®/Rekovelle®) Micronized progesterone 200mg (Utrogestan®) Ovulation trigger: Triptorelin 0.2 mg (Decapeptyl®) + Recombinant human chorionic gonadotropin (rhCG) 250μg (Ovitrelle®)
15734076|NCT04992468|Drug|Ovulation triggering with GnRH-a|rFSH 225-300 IU (Gonal-F®/Puregon®/Ovaleap®/ Rekovelle®) Micronized progesterone 200mg (Utrogestan®) Ovulation trigger: Triptorelin 0.2 mg (Decapeptyl®)
15734077|NCT04992455|Other|Older Patients Receiving Chemotherapy|No Intervention
15734078|NCT04992442|Drug|TAK-935 Oral Tablet|TAK-935 tablet
15734079|NCT04992442|Drug|[14C]TAK-935 IV Infusion|[14C]TAK-935 IV infusion
15734080|NCT04992442|Drug|[14C]TAK-935 Oral Solution|[14C]TAK-935 oral solution
15734081|NCT04992429|Procedure|SphinkeeperTM|The SphinkeeperTM includes up to 10 self-expandable prostheses, which get inserted into the intersphincteric place. They are made of inert Hyexpan (polyacrylonitrile)
15734082|NCT04992416|Procedure|immediate implant placement with ATBG and SMV|immediate implant placement using ATBG as a graft material, with SMV
15734083|NCT04992416|Procedure|immediate implant placement with ATBG|immediate implant placement using ATBG as a graft material without SMV
15734084|NCT04992390|Behavioral|Brief digital imagery-competing task intervention|"First session guided by a researcher: A memory cue followed by playing the brief digital imagery-competing task with mental rotation instructions.
~Option to engage in self-administered/guided sessions after the first session and record their intrusive memories (symptom monitoring)."
15734085|NCT04992377|Drug|R-EPOCH in Combination With Ibrutinib|"Induction:
~(21-day per cycle) Ibrutinib:420mg given orally , once daily.
~Details of R-DA-EPOCH are as follows:
~Rituximab: 375 mg/m2 given intravenously (IV) on day 0 Etoposide: 50 mg/m2 given CIV from day 1-4 Doxorubicin: 10 mg/m2 given CIV from day 1-4 Vincristine: 0.4 mg/m2 given CIV from day 1-4 Cyclophosphamide: 750 mg/m2/day IV on day 5 Prednisone: 60 mg/m2 given orally bid on days 1-5. Patients who achieve CR after 4 cycles enter the consolidation treatment ; Patients with PR after 4 cycles would receive another 2 cycles of R-EPOCH + ibrutinib induction therapy, they could enter the consolidation treatment if they achieve CR ,withdrawn from the study if they achieve ≤ PR; Patients with SD/PD after 4 cycles of treatment are withdrawn from the study.
~Consolidation:
~2 cycles of R-EPOCH + Ibrutinib (dose as before) treatment
~Maintenance:
~Ibrutinib 420 mg/day for 24 months or until disease progression or intolerable toxicity"
15734086|NCT04992364|Other|Burnout and Clinical performances questionnaires|Subjects were given questionnaires to assess burnout score and clinical performances
15734087|NCT04992351|Procedure|WALANT|WALANT as anesthesia method for upper and lower limb palstic surgery operations
15734088|NCT04992338|Device|Mobile app|The CarpeDiem application is a mobile application, designed in collaboration with the Health and Nutrition Technology Unit (UTNS, Eurecat) and the translational research group on respiratory medicine of the Institut de Recerca Biomèdica de Lleida. The application is available for devices with Android as the operative system and its advanced interface allows the user to monitor their physical activity, sleep and diet and motivate them to meet personalized goals through gamification. To do this, the user must answer the questionnaires that they will find on the main page of the application with a predetermined frequency, as well as perform missions that will help them acquire healthier habits. In addition, the user will receive motivational messages and recommendations through notifications that will help and guide them to achieve their missions and achieve their goals, and as a result of changing habits.
15734089|NCT04992325|Diagnostic Test|Anterior segment-optical coherence tomography|Each subject underwent anterior segment -optical coherence tomography to evaluate the total corneal, epthelium and stromal thicknesses.
15734091|NCT04992299|Behavioral|Mindfulness-Based Intervention|6-week mindfulness-based intervention of 6 weekly 1 hour group sessions
15734092|NCT04992299|Behavioral|Cognitive-Behavioral Therapy|6-week cognitive-behavioral therapy intervention of 6 weekly 1 hour group sessions
15734093|NCT04992299|Behavioral|Health Education|6-week health education didactic program of 6 weekly 1 hour group sessions
15734094|NCT04992286|Other|questionnaire|questionnaire to evaluate fragility
15734095|NCT04992286|Other|accelerometer|To evaluate physical activity level
15734097|NCT04992260|Biological|Inactivated COVID-19 Vaccine|The inactivated COVID-19 vaccine was manufactured by Sinovac Research& Development Co., Ltd..600SU Inactivated SARS-COV-2 virus in 0·5 mL of aluminium hydroxide solution per injection
15734098|NCT04992260|Biological|Controlled vaccine|The placebo was manufactured by Sinovac Research& Development Co., Ltd.The composition is aluminium hydroxide,The appearance of the placebo is consistent with the vaccine, which is a milky-white suspension.
15734099|NCT04992247|Biological|COVI-MSC|"2, 4 or 6 MSC vials (approximately 15 million cells/vial) will be intravenously infused on Day 0, Day 2, or Day 4 depending on assignment to treatment group.
~Group A: 2 MSC vials infused on D0 and 2 vials of placebo on D2 and D4
~Group B: 2 MSC vials infused on D0 and D2 and 2 vials of placebo on D4
~Group C: 2 MSC vials infused on D0 and D4 and 2 vials of placebo on D2
~Group D: 2 MSC vials infused on D0, D2 and D4"
15734100|NCT04992247|Biological|Placebo|6 vials of placebo will be intravenously infused on Day 0, Day 2, or Day 4.
15734101|NCT04992221|Procedure|arterial line|arterial line inserted for invasice mointroing and sampling
15734103|NCT04992195|Diagnostic Test|Laboratory tests and Montreal Cognitive Assessment|Laboratory tests at baseline and 16 weeks (+/-4 weeks) after 2nd dose of vaccine and serological testing for IgG antibody. Participants who have a scheduled vaccination date shall undergo an MRI brain 16 weeks (+/-4 weeks) after the second dose of COVID-19 vaccination (either SinoVac or BioNTech). A face-to-face assessment 16 weeks (+/-4 weeks) will also be conducted after the 2nd dose of COVID-vaccine for evaluation of any clinical events, followed by a phone visit every 6 months. Cognitive assessment by MoCA will be performed at baseline, 16 weeks (+/-4 weeks) then every 12 months after the 2nd dose of COVID-19 vaccine.
15734104|NCT04992195|Diagnostic Test|Laboratory tests and Montreal Cognitive Assessment|Laboratory tests at baseline and serological testing for IgG antibody to exclude past COVID-19 infection. The timing of the second MRI brain, laboratory tests, clinical and cognitive assessment will be matched with the timing in the vaccination group are available.
15734105|NCT04992182|Biological|Placebo|0.3 mL IM saline solution
15734106|NCT04992182|Biological|Inactivated vaccine booster|0.5 mL IM
15734107|NCT04992182|Biological|mRNA vaccine booster|0.3 mL IM
15734108|NCT04992182|Drug|Viral vector vaccine booster|0.5 mL IM
15734109|NCT04992169|Behavioral|Smartphone-App Parent Training in Pivotal Response Treatment|Parents are trained in Pivotal Response Treatment, Pivotal Response Treatment is a well-known, scientifically supported treatment that focuses on using child motivation, play-based lessons, and parent involvement to target the language skills and social engagement of children with autism. The core smartphone app will offer eight interactive lessons in PRT, consisting of video examples, slides, and brief quizzes.
15734110|NCT04992156|Drug|Palbociclib|Palbociclib 125mg/d
15734111|NCT04992143|Procedure|TACE|TACE first ,and more TACE could be performed when it is necessary.
15734112|NCT04992143|Drug|Tilelizumab|Tilelizumab 240mg per 3weeks ivgtt within 1 week after the first TACE
15734113|NCT04992143|Drug|Sorafenib|Sorafenib should be administered 400 mg twice /day orally within 1 week after the first TACE
15734114|NCT04992130|Behavioral|Pre-season supplementary neurologic training program|A two-month standardized, pre-season, supplementary multi-modal training program will be prescribed to 200 athletes (intervention cohort) by a team of experienced sport science and medicine professionals targeting the specific intrinsic risk factors of interest identified in the current concussion and ACL prevention literature.
15734115|NCT04992117|Other|NO INTERVENTION|NO INTERVENTION
15734116|NCT04992091|Other|constructive debriefing|Constructive debriefing was applied to an interventional group Traditional debriefing was applied on noninterventional group
15734117|NCT04992078|Device|NAVIO/CORI Surgical System|Unicompartmental knee replacement with robotic assistance
15734118|NCT04992078|Procedure|Non-robotic conventional instrumentation|Unicompartmental knee replacement with non-robotic conventional instrumentation
15734126|NCT04992052|Device|Bone wax|The surgeons will apply the bone wax to the exposed cancellous bone after the implant has been cemented in place in patients randomized to the treatment arm.
15734127|NCT04992039|Other|WHO HEARTS technical package|"Components of WHO HEARTS technical package are
~Universal BP screening via A&D arm-in BP device.
~Training of Medical Officers and Nurses on BP measurement using standard techniques.
~Training of the nurses on screening, registration data collection via the Simple mobile smart-phone digital clinical hypertension information application.
~Use of a drug and dose specific hypertension treatment protocol.
~Standardized inventory and procurement practice to ensure a reliable supply of protocol medications.
~Training and support for team-based model of hypertension care delivery.
~Access to the Simple data dashboard for program monitoring.
~Standardized procedure for patient follow-up.
~Community-based prescription refilling."
15734128|NCT04992026|Procedure|robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection|Robot assisted laparoscopic prostatectomy + enlarged pelvic lymph node dissection will be performed.
15734129|NCT04992026|Drug|1.Abiraterone Acetate Tablets|1000mg(4 tablets, 250mg per tablet) daily for 6 cycles
15734130|NCT04992026|Drug|Prednisone Acetate Tablets|5 mg oral low dose prednisone taken along with Abiraterone Acetate Tablets
15734131|NCT04992013|Drug|Niraparib|Capsule taken by mouth
15734132|NCT04992000|Other|4-free app + PHN intervention|same mentioned in groups
15734133|NCT04991974|Behavioral|Patient Navigation|A Patient Navigator will work with participants to facilitate their entry into OUD treatment in the community (e.g., by selecting a program, scheduling intake appointments, and addressing barriers to facilitate successful treatment linkage).
15734134|NCT04991974|Drug|Buprenorphine|"Buprenorphine is an FDA-approved medication for opioid dependence, and will be used in this study consistent with its approved use (but will be initiated in the novel setting of sexual health clinics in this health services study).
~Participants will meet with an sexual health clinic provider who holds a waiver to prescribe buprenorphine. Participants will initiate buprenorphine treatment via a home induction under the direction of the provider. Because barriers to transfer may take some time to overcome, participants will be able to receive additional bridge buprenorphine up to two times (up to 15 days' supply at a time) until successful transfer to OUD treatment in the community."
15734135|NCT04991961|Diagnostic Test|withdraw antihypertensive drugs|patients need to withdraw of all antihypertensive drugs or change therapy to Doxazosin/Diltiazem for 2-4 weeks prior
15734136|NCT04991948|Drug|CYAD-101|Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells
15734137|NCT04991948|Drug|FOLFOX|5-FU, leucovorin and oxaliplatin
15734138|NCT04991948|Drug|Pembrolizumab|Humanized immunoglobulin G4 (IgG4) monoclonal antibody (mAb)
15734139|NCT04991935|Drug|CC-93538|CC-93538
15734140|NCT04991909|Drug|HRS4800|HRS4800
15734141|NCT04991909|Drug|Placebo|Placebo
15734142|NCT04991896|Drug|Flecainide Injectable Product|Flecainide is given as an IV infusion of 1.5 mg/kg (max 150 mg) in DW 5% over 10 min under continuous monitoring. Concomitant administration of a b-blocker is also applied in all patients. The dose and type of b-blocker are selected according to heart rate during the AF and patient's medical history.
15734143|NCT04991883|Other|case series review of clinical and histological data|We will review all the medical records, radiological imaging, and histological data of these cases. The immunohistochemical analysis of the principal alterated genes identified in this tumor will be performed.
15734144|NCT04991870|Biological|Cord Blood-derived Expanded Allogeneic Natural Killer Cells|Given CB-NK-TGF-betaR2-/NR3C1- intratumorally
15734145|NCT04991870|Procedure|Resection|Undergo surgical resection
15734146|NCT04991857|Other|T-FAME-HF|16-week program adopts a hybrid approach to combine nurse-led home visits, an Apps, tele-care and optimized family support to enhance post-discharge disease management, disease monitoring, and patients' access to the nurse, and telephone visits
15734147|NCT04991857|Other|Control group - HF education program|For patients assigned to the control arm will receive HF education program, the care dyad will receive a 16-week HF education program that comprises a home visit by the team nurse, five bi-weekly online training on self-care through videos on Whatapps/ WeChat with two subsequent telephone follow-up.
15734148|NCT04991844|Behavioral|Intervention Group|Intervention group participants met once a week, for 2.5 hours, over a period of six weeks for the HES workshops. The HES workshops followed a scripted curriculum that incorporated information from the USDA's MyPlateTM, and the USDA 2015-2020 dietary guidelines. Participants were also taught goal-setting, problem-solving through brainstorming, group support, self-assessment and management of dietary and physical activity patterns.
15734149|NCT04991831|Device|Unilateral thalamotomy|Unilateral thalamotomy using focused ultrasound for the treatment of medication-refractory tremor dominant idiopathic Parkinson's Disease.
15734151|NCT04991792|Other|Intervention Group 1: Infant Formula with synbiotics|Infants will receive infant formula during the first 6 months of life
15734152|NCT04991792|Other|Intervention Group 2: Infant Formula with prebiotics|Infants will receive infant formula during the first 6 months of life
15734153|NCT04991792|Other|Control Group 1 and 2: Infant Formula without synbiotics|Infants will receive infant formula during the first 6 months of life
15734154|NCT04991779|Diagnostic Test|AI-assisted cEEG detection tool|"This study is an observational study to evaluate the accuracy of AI-assisted cEEG diagnostic tool with routine care. All patients from the cohort accept cEEG monitoring and AI-assisted cEEG detection tool.
~The tool included a quantitive EEG neural signal processing pipeline to extract features from the original signal datasets, machine learning models based on gradient boosted model for prediction.
~The reference standard is the electrographic seizures interpreted by 3 clinicians who had attended the uniformly training program and were certified by the Chinese Anti-Epilepsy Association."
15734155|NCT04991766|Drug|[¹⁴C]-LY3484356|Administered orally.
15734156|NCT04991766|Drug|LY3484356|Administered orally.
15734157|NCT04991766|Drug|[¹⁴C]-LY3484356 (IV)|Administered IV.
15734160|NCT04991740|Drug|JNJ-78306358|JNJ-78306358 will be administered.
15747885|NCT04877288|Drug|Corticosteroids|Specified dose on Specified days
15734161|NCT04991727|Behavioral|recruitment maneuvers|"Immediately after endotracheal intubation is completed
~First RM (pulmonary retraction), maintain pressure at 40cmH2O for 30s, and then
~Mechanical ventilation was maintained with 7cmH2O PEEP, and the RMS was repeated every 30 minutes until the end of surgery"
15734162|NCT04991714|Drug|Lactisole|sweet taste inhibitor (decreases sweetness)
15734163|NCT04991714|Drug|Rebaudioside M|Sweetener (increases sweetness)
15734164|NCT04991714|Other|Sucrose|10% Sucrose corresponding to a regular soft drink
15734165|NCT04991688|Drug|BOTOX-A|10 injections of 20 U of toxin will be made into the rectum 5, 10 and 15 cm above the pectinate line. At each level, 3 injections of 20 U will be performed in the submucosa, circumferentially.The last injection is made 20 cm above the pectinate line. Total does not exceed 200U of Botox-A
15734166|NCT04991675|Behavioral|pelvic floor muscle exercises|During the first visit, the anatomy of the pelvic floor and the purpose of the program were explained. Exercises were taught in the supine position, as described by Kegel (1948), it was confirmed that the women learned to use the correct muscles with vaginal palpation. During the exercise, the participants were informed not to pull the abdomen inwards, not to tighten their legs and hip muscles, and not move their pelvis.
15734167|NCT04991675|Behavioral|diaphragmatic breathing exercises|During the first visit, the anatomy of the diaphragm and abdominal wall and the purpose of the program were explained. Diaphragmatic breathing exercise was taught in supine position. The movement of the symphysis pubis was examined to confirm that the pelvic floors' movement was also involved breathing. Abdominal palpation was used to elicit unawareness of the diaphragmatic breathing and to assess whether contractions were performed correctly.
15734168|NCT04991662|Drug|metaraminol|Infusion of metaraminol adjusted according to body weight to obtain higher pH value of fetal umbilical artery blood.
15734169|NCT04991662|Drug|Phenylephrine|Infusion of Phenylephrine adjusted according to body weight to obtain higher pH value of fetal umbilical artery blood.
15734170|NCT04991662|Drug|Norepinephrine|Infusion of Norepinephrine adjusted according to body weight to obtain higher pH value of fetal umbilical artery blood.
15734171|NCT04991649|Behavioral|Acceptance and Commitment Therapy-based Asthma Management Training Program|In addition to the routine pediatric asthma outpatient service as received with the TAU group, participants in the ACT group will additionally receive a two-weekly 2-hour Positive Parenting Program (Triple-P) and a four-weekly 2-hour ACT program (a total of six weekly sessions, 6-8 parents per group). The Triple-P aims to increase parental self-regulation and positive parenting practices to promote child cooperation, lead to consistent discipline and promote routines in childhood asthma management. On the other hand, The ACT sessions foster parents' psychological flexibility to cultivate non-judgmental acceptance of difficult parenting experiences, be mindful in daily parenting, develop an observer-self, and promote commitment to one's values.
15734172|NCT04991649|Behavioral|Treatment-as-usual Group|Participants in the treatment-as-usual (TAU) group will receive routine pediatric asthma outpatient services. These services include regular follow-up appointments once every 3-6 months for reviewing the child's health conditions by pediatricians, refilling medications and asthma education (1.5-2 hours every 3-4 weeks) by Advanced Practice Nurse specialized in pediatric respiratory care, and referrals to community care/welfare services by psychiatrist/medical social worker for parental training in ADHD care.
15734173|NCT04991636|Procedure|Angioscan|"La procédure d'étude prévoit de prendre des images pendant une inspiration profonde ainsi que pendant une expiration profonde. Cette deuxième mesure ne nécessite pas l'administration d'une quantité supplémentaire de produit de contraste. Cependant, le temps d'exposition aux rayonnements ionisants est doublé. L'examen utilise une acquisition hélicoïdale en mode rapide. La durée de l'hélice est de l'ordre de 2 secondes en phase d'inspiration, puis il y a un délai de 5 secondes de machine ( demi-tour ) et à nouveau 2 secondes d'exposition en phase d'expiration, soit 4 secondes d'exposition effective aux rayonnements ionisants, le temps de la prise d'image et 9 secondes le temps total de l'examen. l'image et 9 secondes la durée totale de l'examen."
15734174|NCT04991623|Device|Kinesiology taping|We used kinesiology taping in abdominal muscles
15734175|NCT04991623|Other|Conventional physiotherapy|We used conventional physiotherapy to comparate
15734176|NCT04991610|Radiation|computed tomography|CT scans will be obtained from patients lying in a supine position using 120 kV tube voltage, 150 effective mA and 1 mm slice thickness parameters.
15734177|NCT04991597|Other|Cold Compress Pack|Palmar aspect of forearm will have a cold compress pack placed on it.
15734178|NCT04991597|Other|Room Temperature Compress Pack|Palmar aspect of forearm will have a room temperature compress pack placed on it.
15734179|NCT04991597|Drug|Lidocaine Epinephrine|Lidocaine with epinephrine will be buffered 3:1 with sodium bicarbonate
15734180|NCT04991597|Drug|Lidocaine Epinephrine|Lidocaine with epinephrine will be buffered 9:1 with sodium bicarbonate
15734181|NCT04991584|Drug|Amoxicillin,Tetracycline,Furazolidone,Levofloxacin,Vonoprazan fumarate, Esomeprazole ,|Patients will go through a gastroscopy and antimicrobial susceptibility test. Liver and kidney function will be monitored by blood test before and after the treatment.
15734182|NCT04991571|Drug|Zibotentan (Treatment A)|Zibotentan capsule will be administered orally as multiple doses in Part 1 and as single dose in Part 2.
15734183|NCT04991571|Drug|Dapagliflozin (Treatment A)|Dapagliflozin tablet will be administered orally as single dose in Part 2.
15734184|NCT04991571|Drug|Zibotentan/Dapagliflozin - Formulation 1 (Treatment B)|Zibotentan/Dapagliflozin tablet will be administered orally as single dose in Part 2.
15734185|NCT04991571|Drug|Zibotentan/Dapagliflozin - Formulation 2 (Treatment C)|Zibotentan/Dapagliflozin tablet will be administered orally as single dose in Part 2.
15734186|NCT04991545|Device|Application of Infrared (Active IRD/ IRRIS) device|"The first operator experienced with video-laryngoscopy intubation will do Before inducing anesthesia, the second operator will open the randomization envelope and adhere IRRIS/IRD device to the anterior skin of the neck above the sternal notch according to the group of patients After confirming lack of discomfort during application of the IRRIS/IRD device,
~After complete relaxation, Laryngoscopy will be performed by the first operator using video laryngoscope (Glidescope Verathon Medical, BC, Canada or C-Mac Storz, Germany) to insert the tracheal tube. The endotracheal tube will be armed with a malleable stylet and to be molded to a curved 'hockey stick or the same curve of the laryngoscopic blade's shape. We will divide the patient according to device into two groups:
~Group A: control group
~Group B: Intervention group using Infrared"
15750110|NCT04859075|Other|Bifidobacterium longum 35624|1 capsule daily
15734189|NCT04991493|Drug|Tramadol hydrochloride|"pre-tramadol group: 1mg/kg of tramadol will be injected intravenously 15 minutes before anesthesia.
~post-tramadol group: 1mg/kg of tramadol will be injected intravenously 15 minutes before anesthesia."
15734190|NCT04991493|Other|Normal Saline|"pre-tramadol group: Normal Saline will be injected intravenously when the incision was washed and sutured.
~post-tramadol group: Normal Saline will be injected intravenously 15 minutes before anesthesia."
15734191|NCT04991480|Drug|ART4215|Participants will receive ART4215 by mouth daily in 21 day cycles.
15734192|NCT04991480|Drug|Talazoparib|Talazoparib will be administered at a dose of 1 mg or 0.75 mg by mouth daily in 21 day cycles.
15734193|NCT04991467|Behavioral|CARE Program and Valera Application with care manager functionality|Participant will take part in 12 week CARE program and receive the Valera health application which will provide parent education materials as well as the ability to connect to their child's treatment team via care manager.
15734194|NCT04991467|Behavioral|Valera Application with care manager functionality|Participant will receive the Valera health application which will provide parent education materials and the ability to connect to their child's treatment team via care manger.
15734195|NCT04991467|Behavioral|CARE Program|Participant will take part in 12 week CARE program.
15734196|NCT04991467|Behavioral|Valera Application|Participant will receive the Valera health application which will provide parent education materials.
15734197|NCT04991467|Behavioral|CARE Program and Valera Application|Participant will take part in 12 week CARE program and receive the Valera health application which will provide parent education materials.
15734198|NCT04991454|Drug|129Xe Hyperpolarized|Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC), as is the case for all protocols currently carried out under IND 109,490.
15734199|NCT04991441|Dietary Supplement|Controlled Dietary Sodium Restriction|Participants will be provided with 2 meals and snacks daily, for 30 days (days 1-30) and 1 meal and snacks daily, for 30 days (days 31-60). These meals should meet KDQOI guidelines for energy and protein (30-35 kcal/kg & 1.2 g/kg) as well as low phosphorus, potassium, and sodium. The meals are formulated to less than 600-800 mg sodium each (<2,000g/day) and will be ordered and delivered through momsmeals.com
15734200|NCT04991441|Dietary Supplement|Control Diet & Controlled Dietary Sodium Restriction|Participants will follow a Observational Control Diet (CON) diet (Months 1-5) followed by an Controlled Dietary Sodium Restriction (INT) diet (Months 6-7).
15734201|NCT04991428|Other|Transcranial direct current stimulation|tDCS is a form of non-invasive brain stimulation. tDCS is an established research tool for non-invasive modulation of neuroplasticity. It uses low-intensity DC currents to modulate spontaneous neuronal network activity by altering the resting membrane potential. Anodal tDCS has been shown to increase cortical excitability, reduce regional levels of GABA enhance LTP and synaptic plasticity.
15734202|NCT04991415|Other|Manual Therapy|
15734203|NCT04991402|Device|Dolutegravir-based antiretroviral therapy|"This study focuses on the impact of Dolutegravir (DTG)-based antiretroviral therapy (ART) on metabolic health of women and children in pregnancy, delivery and beyond. In order to understand the potential adverse effects of DTG, pregnant women living with HIV- both those initialing DTG-based ART in pregnancy as well as those who were established on DTG-based ART prior to pregnancy, will be less than or equal to 14 weeks' gestation at enrollment to allow for detection of metabolic abnormalities as they begin to develop during the course of pregnancy.
~This is considered standard of care."
15734204|NCT04991389|Drug|129-Xe|Inhaled contrast for MRI
15734205|NCT04991376|Diagnostic Test|Blood-specific miRNA levels|Blood-specific miRNA levels associated with renal tubular damage change in patients treated with vancomycin or gentamicin compared to septic patients treated with other antimicrobials.
15734206|NCT04991363|Procedure|Bleaching|Digital images for each patient will be taken once with the camera fixed on the classic tripod and again when the camera was fixed on the ISD , then horizontal and vertical measurements of the canines will be recorded by using a computer software on the digital images, then bleaching will be fine for all patients, then a second set of images will be taken again with the tripod and then with ISD, then measurements will be repeated and compared with the first set of images
15734207|NCT04991350|Drug|Intravitreal ranibizumab|Intravitreal injection of 0.3 mg/0.05 ml ranibizumab will be performed monthly for 3 months.
15734208|NCT04991350|Drug|Intravitreal bevacizumab|Intravitreal injection of 1.25 mg/0.05 ml bevacizumab will be performed monthly for 3 months.
15734209|NCT04991337|Behavioral|Low-intensity excercize group|Low intensity excercize (heart rate below 75% of maximum heart rate) for a period of 16 weeks
15734210|NCT04991337|Behavioral|High-Intensity excersize group|at least three weekly sessions of high intensity training, corresponding to a HR above 85% of HRmax, and otherwise continue endurance exercise as usual.
15734211|NCT04991324|Drug|Vitamin D3|24,000 IU cholecalciferol
15734212|NCT04991311|Drug|Glepaglutide|Glepaglutide will be delivered in a single-use autoinjector.
15734213|NCT04991298|Drug|Oral premedication|Oral anesthesia premedication for congenital Cardiac surgery
15734214|NCT04991272|Other|prewarming and warmed fluid infusion|prewarming with forced air warming system and warmed fluid infusion.
15734215|NCT04991259|Procedure|Continuous Renal Replacement Therapy (CRRT)|Continuous renal replacement therapy will be administered as continuous venovenous hemodiafiltration (CVVHDF) using Prisma and Prismaflex (Gambro) devices, with blood flows ranging from 150-180 mL/hr and target effluent rates of 20 - 25 mL/kg/hr. Anticoagulation was not used during dialysis. CRRT would be continued until resolution of cerebral edema and in decrease in ammonia levels below 150 ug/dl or in those who develop adverse effects of therapy.
15734216|NCT04991259|Other|Standard Medical Treatment|In the L- ICU, patients will be managed by a multidisciplinary team. Intubation and ventilation will be undertaken for standard indications in addition to the development of grade 3 encephalopathy or evidence of cerebral edema on CT-scan. Fluid management will be done with crystalloids, with the use of colloids (5% albumin) in patients with severe hypoalbuminemia (serum albumin less than 2.5gm/dl). Norepinephrine will be the primary vasopressor used to target a mean arterial pressure of 65-70 mm of Hg. with adjunctive use of intravenous low dose hydrocortisone and vasopressin in patients not responsive to initial therapy.
15734217|NCT04991246|Other|Antigenic tests (on saliva samples)|SARS-CoV-2 screening tests: two massive antigenic tests campaigns (on salivary samples).
15734218|NCT04991246|Other|Individual electronic sensor port|Individual electronic sensor recording contacts but not their location (in the form of a bracelet, a key ring or a badge) Contact data collection points (5 maximum, located at compulsory passage points for participants). When a sensor is close to one of these terminals, it discharges its contacts in seconds.
15734219|NCT04991246|Other|Atmospheric measurements of CO2|Atmospheric measurements of CO2 in the relevant closed places of the faculty (lectures / practical work / BU / refectory): battery operated sensors. When a sensor is installed in a place, the ventilation conditions (number of open windows, etc.) as well as the number of people present will be noted.
15734220|NCT04991233|Procedure|Endoscopic surgery|The endoscopic surgery will be conducted to evacuate the hemorrhage within 24 hours after SCH.
15734221|NCT04991233|Procedure|Suboccipital craniotomy surgery|The suboccipital craniotomy surgery will be conducted to evacuate the hemorrhage within 24 hours after SCH.
15734222|NCT04991220|Procedure|Preoxygenation|Taking 8 deep breaths at 10 l/min of 100% oxygen for 1 minute with forced inspiration for pre-oxygenation
15734223|NCT04991207|Drug|BIA 5-1058|Oral BIA 5-1058 (Zamicastat) 100 mg tablets
15734224|NCT04991207|Drug|bosentan|Oral Tracleer (bosentan) 125 mg film coated tablets
15734225|NCT04991194|Drug|BIA 5-1058|Each subject was administered either 1200 mg (Part 1) or 400 mg (Part 2) BIA 5-1058 od for 10 days, in fasting conditions for 8 hours [Day (D)2 to D9] or 10 hours (D1 and D13), and remained fasted for 2 hours (D2 to D9) or 4 hours (D1 and D13) post-dose. The formulation was tablets 100 mg and the mode of administration was oral.
15734226|NCT04991181|Drug|400 mg BIA 5-1058|Capsules, oral administered to subjects between 08:00 and 09:00 hours in the morning of Day 1after an overnight fast of at least 10 hours. The study drug was swallowed together with 240 mL tap water (room temperature).
15734227|NCT04991168|Other|Questionnaire|Two questionnaires used to assess the state of knowledge and practices in oral health. An oral assessment will be carried out for voluntary patients.
15734228|NCT04991155|Drug|BIA 5-1058|BIA 5-1058 (tablets 100 mg) was administered orally with 240 mL (Part 1) or 270 mL (Part 2 and Part 3) of water, in one period in the morning under fasting conditions (after at least a 10-hour overnight fast), in one period in the morning after a moderate meal, and in the other period at lunch after a moderate meal.
15734229|NCT04991129|Drug|WJ01024|5mg: WJ01024, Q4W, twice per week
15734230|NCT04991129|Drug|WJ01024|10mg: WJ01024, Q4W, twice per week
15734231|NCT04991129|Drug|WJ01024|20mg: WJ01024, Q4W, twice per week
15734232|NCT04991129|Drug|WJ01024|40mg: WJ01024, Q4W, twice per week
15734233|NCT04991129|Drug|WJ01024|60mg: WJ01024, Q4W, twice per week
15734234|NCT04991129|Drug|WJ01024|80mg: WJ01024, Q4W, twice per week
15734235|NCT04991129|Drug|WJ01024|100mg: WJ01024, Q4W, twice per week
15734236|NCT04991129|Drug|WJ01024|120mg: WJ01024, Q4W, twice per week
15734237|NCT04991129|Drug|WJ01024|140mg: WJ01024, Q4W, twice per week
15734238|NCT04991129|Drug|WJ01024|1600mg: WJ01024, Q4W, twice per week
15734239|NCT04991116|Drug|TILD sub-cutaneous (SC) injection|1 mL injection of study medication
15734241|NCT04991090|Radiation|escalation dose of LLNs|The lymph nodes (SA ≥ 5 mm) existed at the internal iliac and obturator would be delineated, named as GTVnd, and received a radiation dose boost of 58Gy.
15734242|NCT04991077|Biological|analyse of angiogenic, vasoactive and VEGF systems|the angiogenic, vasoactive and VEGF systems will be analysed through blood and urine sampling. These samples will be collected at the time of malignant hypertension diagnosis and repeated one month later, in 30 patients (patients group). The same tests will be performed once in 15 patients with severe non-malignant hypertension, constituting the control group.
15734243|NCT04991064|Other|Complete denture base modified by Titanium dioxide nanoparticles.|Titanium dioxide nanoparticles will be mixed with resin powder of the denture base before mixing the powder and liquid of the heat cure denture base material.
15734244|NCT04991038|Device|DAISe Device|Thrombectomy using the DAISE device
15734245|NCT04991038|Device|Trevo or Solitaire|Thrombectomy using TREVO or Solitaire device
15734246|NCT04991025|Drug|Cisplatin|Participants with lung adenocarcinoma will receive standard of care neoadjuvant cisplatin 75mg/m2 + pemetrexed 500mg/m2 intravenously on day 1 of a 21 day cycle. Participants with squamous cell lung carcinoma will receive cisplatin 75mg/m2 IV on day 8 of a 21 day cycle + gemcitabine 1000mg/m2 IV days 1 and 8 of a 21 day cycle.
15734247|NCT04991025|Drug|Pemetrexed|Participants with lung adenocarcinoma will receive standard of care neoadjuvant cisplatin 75mg/m2 + pemetrexed 500mg/m2 intravenously on day 1 of a 21 day cycle
15734248|NCT04991025|Drug|Gemcitabine|Participants with squamous cell lung carcinoma will receive cisplatin 75mg/m2 IV on day 8 of a 21 day cycle + gemcitabine 1000mg/m2 IV days 1 and 8 of a 21 day cycle.
15734249|NCT04991025|Drug|Carboplatin|Participants not eligible for cisplatin (per treating physician discretion) may receive carboplatin at AUC = 5 instead of cisplatin.
15734250|NCT04991025|Drug|Certolizumab|Certolizumab 400mg subq will be administered in clinic within 1 hour before the start of chemotherapy on day 1 of a 21 day cycle.
15734251|NCT04991012|Device|PDT Therapy|the olp was photosensitized with methylen blue and was irradiated with a semiconductor laser with a wavelength of 650 nm, using a dose of 120 J / cm2 and power density
15734252|NCT04991012|Drug|Triamcinolone (Substance) therapy side|th The OLP on the other side was treated by daily sticking a cut-to-size carrier with 0.05% triamcinolone acetonide for 8 days
15734253|NCT04990999|Procedure|Vestibular Root Extraction|a 1-cm long vestibular access incision was cut, 3-4 mm apical to the mucogingival junction of the involved tooth, then pushing the vestibular pouch in an incisal direction exposing the apical root area, and allowing direct undisturbed access to the root surface
15734254|NCT04990999|Procedure|Atraumatic extractions using periotomes followed by conventional forceps|a sulcular releasing incision suing a micro scalpel was made to detach the surrounding tissues, followed by applying the periotome interproximally into the PDL space, widening the attached periodontal ligaments space.
15734255|NCT04990986|Other|Complex intervention|Will be co-developed during the study.
15734256|NCT04990973|Behavioral|Average American Diet (AAD)|"Participants will follow specified diet requirements.
~Macronutrient targets for the AAD will be approximately 35-37% of energy from fat (13.5% from saturated fat), 15% from protein, and 48-50% from carbohydrates (10 g fiber/d for an average 2000 kcal/d diet)."
15734257|NCT04990973|Behavioral|Mediterranean Diet|"Participants will follow specified diet requirements.
~Macronutrient targets for the Mediterranean diet will be approximately 40% of energy from fat (8.5% from saturated fat), 20% of energy from protein, and 40% from carbohydrates (40 g fiber/d for an average 2000 kcal/d diet)."
15734258|NCT04990960|Other|Physiotherapy|During each session (45 minutes)the patient was assessed and trained in self-treatment exercises assigned to treat their cords. This later method was chosen to ensure regular participation in their exercises and early correction of any inaccuracies in the implementation of the exercises regarding AWS treatment . Or the Physiotherapist worked actively on cords with soft or vigorous stretching.
15734259|NCT04990947|Other|lifestyle / RYGB|No intervention, just 2 different groups will be included
15734260|NCT04990934|Behavioral|Semistructured Interview|Patients with breast cancer (Stage I-III) will be interviewed about their experiences of telemedicine.
15734261|NCT04990921|Combination Product|Palliative Radiation and Pembrolizumab|Stereotactic radiation therapy will be administered as clinically indicated.
15734262|NCT04990895|Other|Electronic Tumour-Specific Patient-Reported Outcomes (ePRO) questionnaires|A web-based portal that prompts participants to enter tumour-specific ePROs at regular intervals in between clinic visits
15734263|NCT04990882|Other|Interpretation of FAPI-PET/CT scans|Each observer's Group will be asked to review FAPI-PET/CT scans of patients with representative cancer types.
15734264|NCT04990869|Dietary Supplement|Nicotinamide Riboside|The patients will receive 1 g of Nicotinamide Riboside or placebo orally every morning and evening for 6 weeks.
15734265|NCT04990869|Dietary Supplement|Placebo|Placebo
15734266|NCT04990856|Procedure|Exercise|Tumor blood flow after acute exercise
15734267|NCT04990830|Drug|Inhaled Low molecular weight heparin|Application with Soft Mist Inhaler
15734268|NCT04990830|Drug|Standard Treatment|Control Group
15734269|NCT04990817|Other|Average American Diet With SoFAS Replaced With Avocado|Replacing energy from solid fats and added sugars (SoFAS) with Avocado as part of an average American diet
15734270|NCT04990817|Other|Average American Diet|Average American diet based on macronutrient analyses from the most recent Nutrition and Health Examination Survey.
15734271|NCT04990804|Drug|Opioid Analgesic|Patients will be provided a prescription for low dose opioids for 5 days postoperatively (Hydrocodone/Acetaminophen 5/325mg or Oxycodone/Acetaminophen 5/325mg) to be taken every 6 hours as needed for pain. Refills may be provided (Hydrocodone/Acetaminophen 5/325mg or Oxycodone/Acetaminophen 5/325mg) if requested by the patient at the providers discretion. In addition, patients will also be prescribed Gabapentin 300mg q8 hours or Pregabalin 75mg twice daily and a muscle relaxer (Methocarbamol 750mg BID or Flexeril 5-10 mg TID) as needed for spasms. Alternative muscle relaxers (Metaxalone 800 mg TID or Tizanidine 2-6 mg TID) may be utilized if contraindications to methocarbamol and cyclobenzaprine exist.
15734272|NCT04990804|Drug|Opioid-Free Postoperative Pain Regimen|Patients will receive no opioids. Pain will be managed with Acetaminophen 1000mg q8 hours, Ketorolac 10mg every 6 hours (for 5 days), Gabapentin 300mg q8 hours or Pregabalin 75mg twice daily, and a muscle relaxer (Methocarbamol 750mg BID or Cyclobenzaprine 5-10 mg TID) all to be taken as scheduled for the first 2 weeks (except Ketorolac - 5 days) postoperatively as side effects permit. Other NSAIDS (Naprosyn 500 mg BID or Ibuprofen 800 mg TID) may be utilized if contraindications to Ketorolac exist. Famotidine (20mg BID) or Omeprazole (20mg daily) will be prescribed along with NSAIDS for GI prophylaxis. Alternative muscle relaxers (Metaxalone 800 mg TID or Tizanidine 2-6 mg TID) may be utilized if contraindications to methocarbamol and cyclobenzaprine exist.
15734273|NCT04990791|Drug|Aspirin 75mg|Aspirin 75mg OD for 14 days
15734274|NCT04990791|Drug|Aspirin 20mg|Aspirin 20mg BD for 14 days
15734275|NCT04990791|Drug|Rivaroxaban 2.5 mg|Rivaroxaban 2.5mg BD
15734276|NCT04990778|Drug|Eprenetapopt|Given IV
15734277|NCT04990778|Drug|Venetoclax|Given PO
15734278|NCT04990765|Behavioral|Virtual Reality Cognitive Behavioral Therapy (CRAVR)|Participants in the intervention group will scheduled for 3 weekly treatment sessions based on manualized cognitive behavioral therapy assisted with alcohol-related high risk situations (6 different scenes from a restaurant) in virtual reality. From scene 1 to scene 6, alchol-related cues increase in intensity in order to perform gradual exposure therapy as a part of CBT. Furthermore, VR scenes are used in CBT to induce craving for coping strategy skill training and cognitive analysis.
15734279|NCT04990765|Behavioral|CBT|The active comparator receives 3 conventional cognitive behavioral therapy sessions with 1 week intervals.
15734280|NCT04990752|Drug|ulinastatin|In the ulinastatin group, early application of ulinastatin was performed for inflammation management and organ protection before ECMO initiation.The recommended clinical routine dosage of ulinastatin is 300,000 IU, q8h (continuous administration for more than 5 days).
15734281|NCT04990739|Drug|MTB-9655|"MTB-9655 is an orally available investigational product that is highly potent as it exhibits selectivity as an ACSS2 inhibitor when tested against a panel of related enzymes. MTB-9655 is formulated as a powder blend in a hydroxypropyl methylcellulose (HPMC) capsule and is presented as 25 mg and 100 mg strengths for oral administration.
~Patients will receive MTB-9655, by mouth daily in 21-day treatment cycles,either 1 hour before mealtime or 2 hours after mealtime."
15734282|NCT04990726|Behavioral|Assessment|Undergo medical assessments
15734283|NCT04990726|Procedure|Biospecimen Collection|Undergo collection of blood samples
15734284|NCT04990726|Other|Quality-of-Life Assessment|Ancillary studies
15734285|NCT04990726|Other|Questionnaire Administration|Complete questionnaires
15734286|NCT04990713|Procedure|Serratus Plane Block (Local Anesthetic) and Intercostal Block (Local Anesthetic)|Patients will receive local anesthetic via serratus plane block as opposed to saline placebo
15734287|NCT04990713|Procedure|Serratus Plane Block (Placebo) and Intercostal Block (Local Anesthestic)|Patients will receive saline placebo via serratus plane block
15734288|NCT04990700|Procedure|Partial rib resection|1 cm partial rib resection during thoracotomy opening
15734695|NCT04987437|Device|Friendly short stem|Total Hip Arthroplasty with Friendly Short stem
15734289|NCT04990687|Device|gammaCore™|"Implantable VNS (iVNS), the electrical stimulation of the nervous system to modulate or modify function, has been FDA approved in the United States since the late 1990s. Implantable VNS therapy has been approved for use in epilepsy and depression.
~When treating major depression with implanted VNS, the widely held belief is that chronic stimulation is required for therapeutic effect. In trials of implantable VNS in major depression, more patients respond at 12 months than at 3 months. Once depressed patients respond to VNS, the effects have been demonstrated to continue for up to five years with continued stimulation. This finding suggests that VNS gradually changes brain function through neuroplasticity."
15734290|NCT04990674|Behavioral|REMOTION|REMOTION is an internet-based program focusing on emotion regulation and aimed at reducing patient symptom severity and improving emotion regulation. It consists of six modules and the structure is based on the extended process model of emotion regulation by Gross (2015). The intervention is currently being studied in an outpatient psychotherapy setting (Bielinski et al., 2020).
15734291|NCT04990674|Behavioral|TAU|Treatment as usual (TAU), refers to standard treatment in an acute inpatient care setting at the Universitäre Psychiatrische Dienste Bern. This treatment includes different standard inpatient psychiatric care components (integrative psychiatric care).
15734292|NCT04990661|Behavioral|intradialytic massage|intradialytic massage for lower extremity ( the massage included both feet and legs up to and including the knee) applied to the intervention group in three sessions a week and a total of six sessions for two weeks
15734293|NCT04990648|Device|Buzzy|Buzzy ® device (Buzzy ® Mini Healthcare) has been used to reduce pain by using local cold application and vibration effect. Buzzy ® was developed by Dr. Amy Baxter in 2009. The size of the Buzzy ® device measures 2⅞ꞌꞌ x 1⅞ꞌꞌ x ⅞ꞌꞌ (7,2 cm x 4,8 cm x 2,2 cm). It is a bee-shaped device made of hard plastic with a vibrating motor (2 settings - fixed and pulsed), powered by a 2AAA battery. There are 4 ice packages and elastic fastening strap. On the part where the device touches the skin, there is an ice package in the shape of a wing. When the button on the device is pressed, it vibrates.
15734294|NCT04990622|Dietary Supplement|Flavonoid-rich diet|Inclusion of foods rich in flavonoids.
15734295|NCT04990609|Device|Endoscopic Ultrasound (EUS)-Guided Radiofrequency Ablation (RFA)|Endoscopic Ultrasound (EUS)-guided Radiofrequency Ablation (RFA) consists of the application of alternating current with a frequency of 350-500 kilohertz (kHz) to the target tissue via a special electrode located at the tip of an echoendoscope. The alternating current causes the vibratory movement of ionic particles in the abutting and adjoining tissue and results in the generation of heat. However, RFA induces not only local disruption of the tumor by heat, but it also produces localized coagulation necrosis of the tumor which induces the release of large amounts of cellular debris which represent a source of tumor antigens that can trigger a host adaptive immune response against the tumor.
15734296|NCT04990609|Drug|Neoadjuvant chemotherapy (NAC)|The NAC regimen will be determined clinically by the participant's physician [possible regimens are either mFOLFIRINOX or Gemcitabine Nab-Paclitaxel +/- Cisplatin (GemAbraxane)].
15734297|NCT04990596|Biological|additional blood sample|One sample per patient will be taken 1 to 3 hours after clopidogrel administration. Four additional tubes of 3 mL each will be collected for the study, for a total volume of 12 mL.
15734298|NCT04990583|Behavioral|Face-to-Face PrEP Adherence Intervention Based on LifeSteps|This single session intervention, based on LifeSteps, will occur with a study adherence coach either in-person or remotely via HIPAA compliant videoconferencing software. The topics covered during the session will include: experience taking PrEP, risk behavior education, mental health and substance use as barriers to adherence, other barriers to adherence, formulating a dosing schedule, storing and transporting medications, and response to slips in adherence. Participants assigned to the Carium condition will also receive an introduction to the Carium app.
15734299|NCT04990583|Behavioral|Adherence Coaching Facilitated by Carium Adherence App|The Carium app will be used to deliver medication reminders to participants, track medication adherence, engage in two-way secure messaging with participants, and connect with participants through a secure video feature. The adherence coach will use the secure messaging feature to support the participant with their adherence
15734300|NCT04990570|Other|Telemedicine in the form Virtual clinic via video consultation|"Pediatric patients, with age ranging from 1 month-14 years, with surgical problems, encountered during the era of Covid-19 pandemic.
~Some of them seen at the OPD clinic, while the majority failed to attend because of Covid-19 associated lock-down and Curfew, thus, rendering their approach to the service.
~Telemedicine, in the form of Virtual clinic, was utilized to address the distressing problem of difficult approach of patients to the pedia surgery OPD because of Covid-19 pandemic restrictive regulatory precautions, to aid in conveying their concerns and bridge the gap in surgeon-patient relationship & encounter."
15734301|NCT04990557|Drug|PD-1 and ACE2 Knockout T Cells|Autologous lymphocytes are collected and both PDCD1 and ACE2 gene knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment
15734302|NCT04990557|Drug|PD-1 and ACE2 Knockout T Cells|Autologous lymphocytes are collected and both PDCD1 and ACE2 gene knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment
15734303|NCT04990557|Drug|PD-1 and ACE2 Knockout T Cells|Autologous lymphocytes are collected and both PDCD1 and ACE2 gene knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment
15734304|NCT04990544|Biological|202-CoV low adjuvant dose|standard dose of 202-CoV with low dose CpG / alum adjuvant
15734305|NCT04990544|Biological|202-CoV low antigen dose|low dose of 202-CoV with CpG / alum adjuvant
15734306|NCT04990544|Biological|202-CoV standard dose|standard dose 202-CoV with CpG / alum adjuvant
15734307|NCT04990544|Biological|Placebo|Normal saline solution
15734308|NCT04990531|Diagnostic Test|Low-field magnetic resonance imaging|Imaging of lung parenchyma by LF-MRI
15734346|NCT04990206|Behavioral|TranS-C|"TranS-C will be provided in eight weekly, one-on-one 50-minute sessions delivered remotely by two-way video conferencing. Each week will include goal setting and homework assignments which will be reviewed in the following session.
~The sessions will include information on sleep and circadian rhythms, behavioral change and motivation, and goal setting. The topics covered in the sessions include establishing regular sleep-wake times, learning a wind-down route, learning a wake-up routine, improving daytime functioning, correcting unhelpful sleep-related beliefs, and maintenance of behavior change."
15735312|NCT04982354|Drug|Busulfan|0.8 mg/kg/dose every six hours x 12 doses administered intravenously
15734309|NCT04990505|Diagnostic Test|lung ventilation/perfusion scintigraphy|"Chest CT-scan will be performed with blocked inspiration.
~Lung ventilation/perfusion scintigraphy imaging will be performed within 24hrs after CT pulmonary angiography, 410MBq of Technegas will be inhaled by patients and ventilation tomography performed thereafter. Then, 185MBq 99mTc-macroaggegates will be injected intravenously followed by the perfusion tomography.
~A combined CT acquisition will be performed.
~The day following lung ventilation/perfusion scintigraphy, 740MBq of Tc99m labeled albumin will be intravenously administered.
~Cardiac gated-blood-pool scintigraphy will be then performed in best septal left anterior oblique and left profile according to specific parameters.
~45-60 min after injection, a non-gated tomographic acquisition over the lungs will be done, with the same parameters than for PS SPECT, resulting in a late albumin acquisition."
15734310|NCT04990492|Diagnostic Test|Paper GAD 7|The paper based GAD 7 that is commonly accepted at clinics
15734311|NCT04990492|Diagnostic Test|Voice Administered GAD 7|This is the voice based GAD 7 that is administered through a Mirror device equipped with Amazon Alexa software.
15734312|NCT04990479|Biological|GAd-PEV|Priming phase including 1 GAd-PEV administration with Standard of Care pembrolizumab (cycle 4).
15734313|NCT04990479|Biological|MVA-PEV|Boosting phase including 3 boosting administrations of MVA-PEV with Standard of Care pembrolizumab (cycles 5, 6 and 7).
15734314|NCT04990466|Drug|IIBR-100|Administration of IIBR-100 vaccine
15734315|NCT04990466|Drug|Active Comparator|Administration of a currently-approved vaccine for COVID-19
15734316|NCT04990453|Other|RPD frameworks fabricated from PEEK material|extracoronal precision attachment RPD frameworks fabricated from PEEK material using milling machine (CAD/CAM technology)
15734319|NCT04990427|Drug|CLBS201|1 x 10^6 to 300 x 10^6 autologous CD34+ cells
15734320|NCT04990427|Drug|Placebo|Isotonic solution with autologous serum and human serum albumin
15734321|NCT04990414|Other|Cognitive Behavioural Therapy|Sessions 1-4 were focused on engagement, assessment of presenting problems, identification of treatment goals and normalization/ psychoeducation. Sessions 5- 14, focused on techniques to manage dissociative responses and/or increase perceived controllability of dissociation. Although further work on dissociation and/or trauma was encouraged, the targets for intervention in subsequent sessions (15-22) and the strategies selected depended on individual formulation of clients' difficulties and negotiation with the client. This could include re-appraisals on negative beliefs about dissociative experiences, cognitive and/or behavioural change strategies targeting core appraisals of voices leading to related distress, trauma-related techniques (e.g., imagery techniques,), or consolidation of a developmental/longitudinal psychological formulation of the client's difficulties. The final two sessions focused on plans for relapse prevention and maintenance of gains.
15734322|NCT04990401|Behavioral|Behavioral Activation Teletherapy|A total of 10 teletherapy sessions to be delivered over 12-14 weeks, designed to increase physical activity among depressed individuals.
15734323|NCT04990388|Biological|UX053|mRNA-based biologic
15734324|NCT04990388|Other|Placebo|consists of the same components as the formulation buffer for UX053
15734325|NCT04990388|Drug|Antipyretic|subjects will receive oral premedication prior to infusion
15734326|NCT04990388|Drug|H2 Blocker|subjects will receive oral premedication prior to infusion
15734327|NCT04990388|Drug|H1 Blocker|subjects will receive oral premedication prior to infusion
15734328|NCT04990375|Device|tDCS|5 sessions of 20-minute tDCS at 2 mA over the dorsolateral prefrontal cortex (35cm² sponge)
15734329|NCT04990362|Dietary Supplement|Pomegranate oil, Mediterranean Diet|Dietary Supplement: Pomegranate oil in a glass bottle of 0.15ml per day +Mediterranean dietary protocol Dietary Supplement: Mediterranean dietary protocol
15734330|NCT04990362|Dietary Supplement|Mediterranean Diet|Dietary Supplement: Mediterranean dietary protocol
15734331|NCT04990349|Drug|Oxygen gas|Targeted PO2 postoxygenator is obtained by modulating ECMO Membrane oxygen fraction.
15734332|NCT04990336|Combination Product|Dachaihu decoction compound|Dachaihu decoction compound includes Bupleurum, Rhubarb, Citrus aurantium, Scutellaria, Pinellia, White Peony, Jujube, Ginger.
15734333|NCT04990336|Drug|Rhubarb single medicine|Rhubarb single medicine
15734334|NCT04990336|Combination Product|Regular therapies|Regular therapies, such as fluid therapy, for acute pancreatitis
15734335|NCT04990323|Biological|ECT-001-CB (UM171-Expanded Cord Blood Transplant)|Single UM171-Expanded CB transplant (CD34+: 2.5-50x10^5/kg, CD3+>1x10^6/kg)
15734336|NCT04990310|Drug|[14C]-CORT113176|[14C]-CORT113176 450 mg lipid formulation capsule for oral administration containing not more than 3.37 megaBequerel 14C.
15734337|NCT04990284|Drug|Opicapone|50 mg hard capsules. Oral administration, once-daily at bedtime, at least 1 hour before or after L-DOPA/carbidopa or benserazide (L-DOPA/DDCI).
15734338|NCT04990284|Drug|L-DOPA/DDCI|L-DOPA/carbidopa or benserazide (L-DOPA/DDCI), 100/25 mg, oral administration
15734339|NCT04990271|Drug|Conbercept ophthalmic injection|Monthly injection of Conbercept from 0~5 months
15734340|NCT04990258|Drug|Subcutaneous infliximab CT-P13 Remsima®SC|Patients will be switched from IV infliximab into subcutaneous infliximab Remsima®SC 120 mg.
15734341|NCT04990245|Diagnostic Test|endoscopic biopsies|patients with planned endoscopy for ulcerative colitis have endosocpic data recorded aswell as biopsy sampling and blood tests
15734342|NCT04990232|Drug|Anakinra or rhIFNγ|In hyper-inflammation anakinra three times daily (every eight hours) for 15 days and sc 0.5 ml N/S 0.9% every other day for 15 days. In immunoparalysis IV 20 ml N/S 0.9% (10ml for patients with creatinine clearance lower than 30ml/min) three times daily (every eight hours) for 15 days and sc rhIFNγ every other day for 15 days.
15734343|NCT04990232|Drug|Placebo|20ml (10ml for patients with creatinine clearance lower than 30ml/min) intravenous (IV) 0.9% saline (N/S) three times daily (every eight hours) for 15 days and 0.5 ml subcutaneous (sc) 1ml 0.9% N/S every other day for a total of 15 days
15734752|NCT04986943|Device|Using ABTHERA Advance without a Wittmann Patch|In this group, patients will be receiving only the ABTHERA Advance product, without the use of the Wittmann Patch
15734347|NCT04990193|Other|Conventional Physical Therapy Protocol|The conventional physical therapy protocol was designed to improve axial stability and trunk steadiness during standing and walking. The conventional therapeutic protocol for every child was 3 sessions/week for 12 consecutive weeks. Every treatment session was conducted for 2 hours with a 15-minutes rest between the two training hours.
15734348|NCT04990193|Other|TheraTog orthotic undergarment with its strapping system|TheraTog orthotic undergarment with its strapping system was applied for eight hours every day for twelve consecutive weeks.
15734349|NCT04990180|Behavioral|Shared Decision Making Intervention|Decision coaching will be provided to the Pulmonary Rehabilitation Specialists to provide the skills needed to facilitate shared decision making between themselves and patients (and carers). The patient decision aid will be an informational booklet which describes the available Pulmonary Rehabilitation options at the University Hospitals of Leicester. It will detail the risks and benefits of each option and provide interactive sections to engage patients with the content, guide them through it, encourage them to attribute personal meaning and preference to each one so they can make an informed and values-based decision about PR.
15734350|NCT04990167|Drug|Tiotropium Bromide|Using Tiotropium as a single agent asthma controller medication
15734351|NCT04990154|Behavioral|a 12-week intradialytic exercise|a 12-week intradialytic exercise (supine lower-limb ergometer, 30 minutes/session, 3 sessions/week)
15734354|NCT04990128|Combination Product|Emcyte PureBMC|The Emcyte PureBMC will be used to concentrate bone marrow aspirate that will be injected into the hip.
15734355|NCT04990128|Drug|Triamcinolone|40 mg (1 mL) triamcinolone and 4 cc of lidocaine 1%
15734356|NCT04990115|Other|root canal shaping|root canal treatment
15734357|NCT04990102|Drug|CPX-351|Daunorubicin 8.8mg/m2 + cytarabine 20mg/m2
15734358|NCT04990089|Device|VIVO|VIVO is a per-procedural planning tool designed to non-invasively identify the origin of a ventricular arrhythmia.
15734359|NCT04990076|Procedure|Hysterectomy|Surgery includes different types of hysterectomy: vaginal hysterectomy, total abdominal hysterectomy and laparoscopic or Robotic hysterectomy. The type of hysterectomy does not influence histological outcome, as long as the uterus is removed in one part (no power morcellation). Indications for surgery and the type of surgery are according to the departments' protocols. If the patient is deemed to be inoperable due to the extent of the disease, a representive biopsy (e.g. trucut biopsy) will be accepted if sufficiently motivated by the oncology team.
15734360|NCT04990063|Drug|Chemotherapy|Standard chemotherapy drug
15734361|NCT04990063|Biological|Adoptive TKC transfer therapy|TKC: co-cultured autologous NK cells and γδT cells
15734362|NCT04990037|Drug|CAN04|Administered intravenously
15734363|NCT04990037|Drug|FOLFIRINOX|Administered intravenously
15734364|NCT04990024|Other|Dietary Intervention Med Diet|The diet will consist of a calorie-restricted Med diet, with 500 Kcal/d energy restriction. The intervention consists of individual and group educational sessions on Med diet. During the group sessions, the RA will go over the benefits of Med diet, what composition it should have, and how to make appropriate choices for meal planning, in addition to providing food lists, by season. The individual sessions with subjects will also allow to individualize the diet plan.
15734365|NCT04990024|Other|Dietary Intervention HP/LC Diet|This is a non-ketogenic diet consisting of ad libitum intake of proteins, fat, and vegetables, with restriction of daily carbohydrates to <130 g/d. The intervention consists of group educational sessions on HP/LC, same as with Med diet (above). The individual sessions with subjects will also allow to individualize the diet plan.
15734366|NCT04990024|Other|Dietary Intervention LF Diet|In this arm, participants will be advised to follow a calorie restricted LF diet with 500 Kcal/d energy restriction. Group and individual educational sessions will be held at the same frequency as the Med and HP/LC diets, and will have a similar content but targeting LF diet.
15734367|NCT04990011|Procedure|BioXclude amnion chorion membrane|The OAC will be closed by the Bioxclude ACM Amnion chorion membrane which is applied over the extraction socket then supported with a buccal advanced flap.
15734368|NCT04989998|Device|Hip7 Software on Kick/ CORI platforms|Total hip arthroplasty surgery using Hip7 software on Kick or CORI platforms using R3 Polarstem implants.
15734369|NCT04989998|Device|Conventional surgical procedures|THA surgery using standard, manual instrumentation and digital templating techniques using R3 polarstem implants.
15734370|NCT04989985|Drug|Oxaliplatin+S-1|"Drug: Oxaliplatin Oxaliplatin: 130mg/m2，iv drip for 2h，d1, q3w
~Drug: S-1 S-1: 40~60mg Bid，d1~14, q3w"
15734371|NCT04989985|Drug|Sinitilimab+oxaliplatin+S-1|"Drug: Sintilimab Sintilimab, recombinant humanized anti-PD-1 monoclonal antibody for injection; 200mg ivdrip, d1, q3w.
~Other Name: PD-1 antibody
~Drug: Oxaliplatin Oxaliplatin: 130mg/m2，iv drip for 2h，d1, q3w
~Drug: S-1 S-1: 40~60mg Bid，d1~14, q3w"
15734372|NCT04989972|Drug|PSIL428|1 mg of psilocybin
15734373|NCT04989972|Dietary Supplement|Oyster mushroom|1 mg of oyster mushroom
15734374|NCT04989972|Drug|PSIL428|1 mg psilocybin
15734375|NCT04989959|Drug|[18F]PT2385|[18F]PT2385 infusion
15734376|NCT04989959|Procedure|Positron Emission Tomography/Computed Tomography|PET/CT scan after [18F]PT2385 infusion
15734377|NCT04989959|Procedure|Biopsy|CT-guided tumor biopsy
15734381|NCT04989933|Procedure|Ultrasound-guided erector spinae plane block|Ultrasound-Guided erector spinae plane block with 0.25% bupivacaine
15734382|NCT04989920|Behavioral|Experimental group: CIMT group (Constraint-Induced Movement Therapy)|2 weeks of intensive therapy delivered 5d/week for 6 hrs/day
15734383|NCT04989881|Device|da Vinci Simulator|Single training session
15734384|NCT04989881|Device|Laparascopic training box|Single training session
15734585|NCT04988334|Other|Wait Control|usual activities
15734385|NCT04989868|Procedure|Trans-Nasal Afferent Loop Decompression|A 14Fr silicon tube with multiple side holes within the range of 15 cm from the tip will be placed into the afferent jejunal limb with its end close to the pancreaticojejunostomy (<3 cm) during the surgery. Continuous closed negative-pressure suction will be applied to that tube for 72 hours and after that the nasogastric tube will be removed. No nasogastric tube will be placed, or the nasogastric tube will be removed immediately after extubation.
15734386|NCT04989868|Procedure|Without Trans-Nasal Afferent Loop Decompression|No decompression tube will be placed. No nasogastric tube will be placed, or the nasogastric tube will be removed immediately after extubation.
15734387|NCT04989855|Drug|Fruquintinib plus Tislelizumab|2 cycles of Fruquintinib(F) 5mg QD d1-d14 + Tislelizumab(T) 200mg IV d1, Q3W as preoperative therapy, and F +T after TME as postoperative therapy for 6 months
15734388|NCT04989842|Behavioral|Curriculum Hannover|The methodology uses a natural variation design within the Dr. Becker Clinical Group. The interventions consist of a face-to-face or a digital psychosomatic aftercare basing upon the concept of the Curriculum Hanover. A control group is included that does not receive these two interventions (but receives a similar rehabilitation treatment to the intervention groups).
15734389|NCT04989829|Drug|SHR6390、Omeprazole|SHR6390 tablet single dose、Omeprazol single dose.
15734390|NCT04989816|Drug|Trastuzumab Deruxtecan|Trastuzumab deruxtecan (T-DXd) by intravenous infusion
15734391|NCT04989803|Drug|Cyclophosphamide|Lymphodepleting chemotherapy administered intravenously
15734392|NCT04989803|Drug|Fludarabine|Lymphodepleting chemotherapy administered intravenously
15734393|NCT04989803|Biological|KITE-363|A single infusion of CAR-transduced autologous T cells administered intravenously
15734394|NCT04989790|Other|PICU Up!|PICU Up! incorporates the screening process for determining a patient's appropriate activity level into the daily rounding workflow for all PICU patients, with a tiered activity plan based on clinical parameters to individualize goals based on each child's unique needs. While the patient's PICU Up! level is based on objective criteria, the interprofessional team collectively determines the daily activity goal(s) through shared decision-making which is documented in the medical record on morning rounds. The intervention facilitates daily discussion of 1) analgesia; 2) extubation readiness testing; 3) sedation level and goal; 4) delirium screening and management; 5) mobility goal including physical and occupational therapy consultation by PICU Day 3; 6) sleep promotion; and 7) family engagement in mobility.
15734395|NCT04989777|Device|IABP (Intra-aortic balloon pump ) implantation|Eligible AMI patients in SCAI-B stage will receive IABP implantation from the femoral artery
15734396|NCT04989751|Diagnostic Test|Electromyography|Electromyography (EMG) would be used at the baseline for dignoisis and furtue analysis.
15734397|NCT04989751|Diagnostic Test|IDEAL MRI|Muscle-speciifc sequences (e.g. IDEAL) would be used to scan patients at baseline and follow-up stages to characterize the fat fraction and atrophy in different muscles.
15734398|NCT04989738|Behavioral|THRIVE intervention|Parents learn responsive parenting skills, such as a) recognizing infant hunger and satiety cues and using feeding more selectively in response to hunger only, b) recognizing other reasons for crying or fussy behavior and using alternative soothing strategies when these other reasons apply, c) learning to lay the foundation for healthy infant sleep and respond to nighttime awakenings to promote self-soothing, and d) learning to introduce complimentary foods at 6 months, provide repeated exposure to a variety of healthy foods using positive role modeling, and allow infants to determine the amount consumed.
15734399|NCT04989738|Behavioral|Active Control|Parents learn about development, safety, and positive parenting without a specific emphasis on feeding, sleep, and soothing.
15734400|NCT04989725|Other|Standard arm|Patients on the standard arm will be treated as per standard of care in our institution. Treatment options could include switching to next systemic therapy line, best supportive care or continuing on current systemic therapy.
15734401|NCT04989725|Radiation|Experimental arm|SABR to all oligoprogressive lesions + continuation of current systemic therapy
15734402|NCT04989712|Other|Exposure|Participants randomised to one of the three exposures
15734403|NCT04989699|Drug|OTX-TKI/Sham|OTX-TKI is one dose so subsequent visits will be sham to maintain the mask
15734404|NCT04989699|Drug|Aflibercept/Sham|Aflibercept administered every 8 weeks
15734405|NCT04989686|Other|Microsampling|Volumetric absorptive microsampling (VAMS) with Tasso-M20 devices allows for the accurate and precise collection of a fixed small volume of blood from a capillary needle without the need for phlebotomy.
15734406|NCT04989673|Other|Biological sampling and collection (serum)|Detection of the dengue virus during the next scheduled biological assessment as part of normal pregnancy monitoring (additional tube of blood) among women from GNES and GNEF groups
15734407|NCT04989673|Other|Biological sampling and collection (placenta)|Detection of dengue virus in the placenta of GE patients (additional tube of placenta)
15734408|NCT04989673|Other|Questionnaire|Questionnaire on the patient's socio-economic conditions (10-minute interview with the Clinical Research Associate, CRA).
15734409|NCT04989673|Other|Data collection|Case Report Form will be completed by a Clinical Research Associate (CRA) from the medical file of the patient concerned and of her child at the 3 visits carried out (Pre inclusion V0 or Inclusion V1, Childbirth V2 and Maternity leave V3).
15734410|NCT04989660|Drug|6% aqueous phenol|1.5 mL of 6% aqueous phenol will be injected at each target genicular nerve under ultrasound guidance.
15734411|NCT04989660|Drug|Isotonic saline|1.5 mL of isotonic saline will be injected at each target genicular nerve under ultrasound guidance.
15734412|NCT04989647|Radiation|No adjuvant therapy|Patients will not receive any type of adjuvant therapy.
15734413|NCT04989647|Radiation|Adjuvant radiotherapy|Patients will receive adjuvant treatment composed of either pelvic radiotherapy external beam radiotherapy ± brachytherapy or concomitant chemoradiotherapy (pelvic radiotherapy + chemotherapy).
15734414|NCT04989634|Behavioral|Intensive dietary and weight management|health education , nutritional analysis and individualized dietary guidance
15734415|NCT04989634|Behavioral|Standard care|Standard prenatal education on diet, nutrition and physical activity
15734416|NCT04989621|Drug|Orelabrutinib and Rituximab|Orelabrutinib 150mg po qd d1-28; Rituximab 375mg/m2 iv.drip d1.
15734417|NCT04989621|Drug|Orelabrutinib|Orelabrutinib 150mg po qd
15734418|NCT04989608|Other|Neuroimaging|realization of a neuroimaging 1 and 3 years after the transient ischemic accident
15734420|NCT04989582|Other|The trauma recovery nursing intervention program|The trauma recovery nursing intervention program was for adults who had experienced trauma and consisted of eight sessions, each lasting 30 min. It included a spoken audio track that was accompanied by visual prompts to provide knowledge on traumatic stress and introduce trauma recovery methods. Its online format made it convenient and widely accessible, and allowed for a low-intensity, cost-effective educational program. The program focused on providing self-help guidelines for clients to develop their mental and physical well-being.
15734421|NCT04989569|Dietary Supplement|Nutritional intervention|In the intervention group, the body composition data (of day 1, 3, 8) will be given to the dietitians for adjusting the diet formula. The diet formula will be adjusted on the discretion of the dietitian caring for the septic patients based on clinical judgement. The policy adopted by the dietary treatment guidelines for sepsis is to adjust the dietary concentration when there is too much extracellular water under the premise of gastrointestinal tolerance. When the skeletal muscle mass loss is too fast, the dietitians will increase the protein intake by 1.2g/kg of body weight. For patients with acute renal failure and excess extracellular water accumulation and muscle loss, the dietitians will adjust the protein, sodium, potassium, calcium and phosphorus content in the formula. The dietitians will give appropriate nutrition prescriptions based on clinical signs, disease diagnosis and biochemical values.
15734422|NCT04989556|Other|Interview|Participate in interview
15734423|NCT04989556|Other|Palliative Therapy|Receive standard symptom management by palliative care team
15734424|NCT04989556|Other|Palliative Therapy|Receive provider initiated remote contact
15734425|NCT04989556|Other|Quality-of-Life Assessment|Ancillary studies
15734426|NCT04989556|Other|Questionnaire Administration|Complete questionnaire
15734427|NCT04989543|Diagnostic Test|vaginal swabs|"Nugent score: Vaginal swabbing with the dry swab, make two smears on slides.
~Cytobacteriological examination: swabbing at the exo-endocrine junction using the swab
~Evaluation of the vaginal microbiota: swabbing at the exo-endocrine junction using the swab"
15734428|NCT04989530|Device|Extracorporeal Shock Wave Therapy|different energy levels of ESWT
15734429|NCT04989517|Drug|AT193|Topical
15734430|NCT04989504|Other|Best Practice|Receive standard of care
15734431|NCT04989504|Device|Wound Dressing Material|Apply Mepitel Film
15734432|NCT04989504|Other|Quality-of-Life Assessment|Ancillary studies
15734433|NCT04989504|Other|Questionnaire Administration|Ancillary studies
15734434|NCT04989491|Drug|Rituximab|One single dose of rituximab intravenously (IV)
15734435|NCT04989491|Other|control group|No treatment
15734436|NCT04989478|Other|Fasting|After the standardized breakfast meal, all participants will only consume water for 24 hours
15734437|NCT04989465|Biological|Investigational 23-valent PPV|The investigational vaccine was manufactured by Sinovac Biotech Co., Ltd.25μg each for serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in 0·5 mL of sodium chloride, sodium dihydrogen phosphate and disodium hydrogen phosphate per injection
15734438|NCT04989465|Biological|Control 23-valent PPV|The control vaccine was manufactured by Chengdu Institute of Biological products Co., Ltd. 25μg each for serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F in 0·5 mL of light disodium phenol phosphate, sodium hydrogen phosphate and sodium chloride per injection
15734439|NCT04989452|Diagnostic Test|Recordings of cough sounds from adults|Smartphone recordings of the cough sounds of participants who enrol in the study and obtain a COVID-19 rt-qPCR result.
15734440|NCT04989439|Other|Electrical impedance tomography and ultrasonography of the lung|Both EIT and LUS are non-invasive methods and do not pose any additional risk for the patient. The LuMon System with pediatric EIT belts (LuMon Belt, Sentec, Landquart, Switzerland) will be used. The belt will be placed on the thorax circumference of the infant and connected to the LuMonConnector (Sentec, Landquart, Switzerland). Small electrical currents (3 mA, 198 kHz) will be repetitively injected in rotation through adjacent electrode pairs, and voltage changes will be measured by all passive electrodes pairs (scan rate 48 Hz). Changes in lung electrical impedance will be continuously recorded for 5 minutes. EIT data will be analyzed off-line using Matlab (Mathworks, Natick, Massachusetts, USA). The regional tidal volume distribution, the homogeneity of tidal ventilation distribution, regional respiratory system compliance, and alveolar overdistension and collapse will be assessed. LUS will be performed by experienced users, with a 10 MHz linear transducer.
15734441|NCT04989426|Other|the state of health of newly arrived migrant patients in the year following their arrival in France|the state of health of newly arrived migrant patients in the year following their arrival in France
15734442|NCT04989413|Drug|Placebo oral drops|use of placebo for 12 weeks
15734443|NCT04989413|Drug|Cannabidiol + Cannabigerol + Tetrahydrocannabinol 133/66/4mg|use of cannabidiol + canabigerol + thc for 12 weeks
15734444|NCT04989400|Drug|Ulipristal Acetate|Group A: received Ulipristal acetate 30mg, starting misoprostol 12 hours later 100µg every 6 hours buccal. Then women in had rest for 24 hours after 5 doses of misoprostol and restarted misoprostol-only in both groups with the same above regimens, repeating the same sequence for two weeks unless there was excessive bleeding or infection or uterine contractions or cervical changes. If failed, patient proceeded to hysterotomy. If patient aborted, an obstetric US was done to assess the presence of remnants in the uterine cavity. Patient with remnants of conception proceeded suction evacuation.
15734445|NCT04989400|Drug|Misoprostol|Group A: received Ulipristal acetate 30mg, starting misoprostol 12 hours later 100µg every 6 hours buccal.Group B: received placebo tablet of same shape , texture of that of ulipristal then 12 hours later start misoprostol 100µg every 6 hours buccal. Then women in both groups had rest for 24 hours after 5 doses of misoprostol and restarted misoprostol-only in both groups with the same above regimens, repeating the same sequence for two weeks unless there was excessive bleeding or infection or uterine contractions or cervical changes. If failed, patient proceeded to hysterotomy. If patient aborted, an obstetric US was done to assess the presence of remnants in the uterine cavity. Patient with remnants of conception proceeded suction evacuation.
15734446|NCT04989387|Drug|INCA00186|INCA00186 will be administered every 2 weeks or 4 weeks as per protocol
15734447|NCT04989387|Drug|Retifanlimab|Retifanlimab will be administered every 4 weeks as per protocol
15734448|NCT04989387|Drug|INCB106385|INCB106385 will be administered orally once or twice a day.
15735313|NCT04982354|Drug|Melphalan|70 mg/m2/day x 2 doses administered intravenously
15734449|NCT04989361|Procedure|Soluble Hyaluronic Acid Microneedle|The soluble hyaluronic acid microneedle eye mask is a nanometer-sized microneedle made of water-soluble hyaluronic acid, which can directly inject the active ingredients into the dermis, and after being absorbed and dissolved by the skin, it can achieve the purpose of improving the water content and elasticity of the skin.
15734450|NCT04989361|Procedure|Non-fractional laser|he non-ablative fractional laser use 1565nm fiber laser, which acts on the target base in the dermis-water. The beam penetrates the epidermis and acts on the dermis. Using the principle of focal light and heat, the tissue cells are heated to initiate the repair process, which promotes increased collagen synthesis, thereby Achieve the effect of firming the skin and improving wrinkles.
15734451|NCT04989348|Procedure|Gonadotrophin releasing hormone antagonist protocol|Women will receive antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger or
15734452|NCT04989348|Procedure|Progestin-primed ovarian stimulation protocol|Women will receive oral medroxyprogesterone 10 mg daily or Duphaston 10mg bd from Day 3 till the day of ovulation trigger.
15734453|NCT04989335|Drug|Bisantrene|Combined escalated dose chemotherapy
15734454|NCT04989335|Drug|Fludarabine|Combined escalated dose chemotherapy
15734455|NCT04989335|Drug|Clofarabine|Combined escalated dose chemotherapy
15734456|NCT04989322|Drug|Pembrolizumab|200 mg Q3W
15734457|NCT04989322|Drug|Lenvatinib|8 mg daily
15734458|NCT04989322|Drug|Pemetrexed|500 mg/m2 Q3W
15734459|NCT04989322|Drug|Carboplatin|AUC5 Q3W
15734460|NCT04989309|Device|Transcranial Magnetic Stimulation|TMS will be delivered in 10 Hz pulses for 2.5 seconds, with behavioral measures of speech perception and object categorization immediately following each pulse. TMS at this schedule is thought to temporarily disrupt activity at the stimulation site.
15734461|NCT04989296|Diagnostic Test|Peripheral blood samples were obtained following the standard procedures.|Taking 4 ml of peripheral blood from patients on an empty stomach.
15734470|NCT04989270|Procedure|General Anesthesia|General anesthesia with intubation, ventilation, intravenous and inhalational anesthetics, opioids and muscle paralysis
15734471|NCT04989270|Procedure|Regional Anesthesia|Spinal Anesthesia, Epidural Anesthesia
15734472|NCT04989257|Drug|Ticagrelor-based dual-antiplatelet therapy|Aspirin with ticagrelor
15734473|NCT04989257|Drug|Clopidogrel-based dual-antiplatelet therapy|Aspirin with clopidogrel
15734474|NCT04989244|Behavioral|Weight loss program|Women with obesity were included to the weight loss program which included physical exercise and dietary guidelines
15734475|NCT04989231|Biological|Investigational sIPV|Three intramuscular injections of the investigational vaccine (0.5 ml) at 0 month ,1 month and 2 months respectively; Single intramuscular injection of the investigational vaccine (0.5 ml) at 18 months
15734476|NCT04989231|Biological|Control IPV|Three intramuscular injections of the control vaccine (0.5 ml) at 0 month ,1 month and 2 months respectively;Single intramuscular injection of the control vaccine (0.5ml) at 18 months
15734477|NCT04989218|Drug|Novel combination of chemotherapy and immunotherapy|This is a study of the combination of platinum based chemotherapy (gemcitabine and cisplatin) and doublet immunotherapy (durvalumab and tremelimumab) in the preoperative setting for intrahepatic cholangiocarcinoma with high risk features. Gemcitabine and cisplatin are chemotherapy agents used in the management of locally advanced and metastatic cholangiocarcinoma. Durvalumab is a programmed cell death ligand 1 (PDL1) blocking antibody, that improves the immune response against cancer. Tremelimumab is an antibody that targets cytotoxic T cell lymphocyte-associated protein 4 (CTLA4) on regulatory T cells. It also improves the immune response against cancer cells
15734478|NCT04989205|Behavioral|Cannabis cessation Program|Lundqvist and Ericsson developed the 'Cannabis Cessation Program' (CCP, Nordic abbreviation: HAP) in Sweden in the 1990s. The method uses a combination of cognitive therapy and psychoeducation and covers the normal withdrawal period for cannabis smoking cessation (up to 8 weeks), comprising ~15 individual sessions. It describes a medical, a psychological, and a social phase, in which the participant is helped to recognize and address typical problems related to each phase, e.g., physical and psychological withdrawal problems. The overarching aim of the program is to help cannabis users to reorganize thinking patterns that developed while they were using cannabis and increase their social and psychological coping skills in relation to quitting cannabis use. The CCP manual has been translated into eight languages, e.g., Norwegian.
15734479|NCT04989192|Diagnostic Test|Scan at CT scanner 1|Patients will undergo imaging on a modern CT scanner with spectral imaging capabilities. A dose neutral spectral acquisition mode will routinely be used. Contrast material protocol and scan ranges are similar among all three arms.
15734480|NCT04989192|Diagnostic Test|Scan at CT scanner 2|Patients will undergo imaging on a modern 128 slice CT-scanner without spectral imaging capabilities. A standard acquisition protocol will be used. Contrast material protocol and scan ranges are similar among all three arms.
15734481|NCT04989192|Diagnostic Test|Scan at CT scanner 3|Patients will undergo imaging on a modern 20 slice CT-scanner without spectral imaging capabilities. A standard acquisition protocol will be used. Contrast material protocol and scan ranges are similar among all three arms.
15734482|NCT04989166|Dietary Supplement|Nano-curcumin|Nano-curcumin soft gels
15734483|NCT04989166|Drug|Placebo|Placebo
15734484|NCT04989153|Diagnostic Test|pepsinogen|serum pepsinogen diagnosed gastric cancer and precanceous lesion
15734485|NCT04989140|Drug|Drug: Ixazomib Drug:pomalidomide Drug:dexamethasone|Treatment was continued until disease progression, unacceptable toxicity
15734486|NCT04989127|Diagnostic Test|Diagnosis|All of the patients withstand a radiological examination, including panoramic radiography, and all were handled by the same surgeon and assistant.
15734487|NCT04989127|Procedure|traditional osteotomies|In all groups the flap incision was triangular in shape which avoids muscle involvement (Archer flap).
15734488|NCT04989127|Biological|Platelet Rich Fibrin|Platelet rich fibrin (PRF), is an example and popular procedure for accelerate healing of soft and hard tissue because of the presence of various growth factors.a blood sample was taken without anticoagulant in 10 mL glass-coated plastic tubes that were immediately centrifuged (Elektro-mag M415P) at 3,000 rpm for 10 min (approximately 400 g) (13). The platelet-poor plasma that accumulated at the top of the tubes was discarded.PRF was dissected approximately 2 mm below its contact point with the red corpuscles situated beneath, to include any remaining platelets that may have localized below the junction between the PRF and red corpuscles.
15734489|NCT04989127|Drug|Antibiotics, Penicillin|Antibiotics are prescribed for the patients.
15734490|NCT04989127|Drug|Analgesic|Analgesics are prescribed for the patients.
15734491|NCT04989127|Drug|Antibiotic|Patients with penicillin allergy
15734492|NCT04989114|Device|nasal continuous positive airway pressure|positive end expiratory pressure will be applied by nasal continuous positive airway pressure
15734493|NCT04989101|Drug|Nigella|The candidate must take one capsule / day of nigella 5 for 21 days (1 bottle). Follow-up should be done weekly for 1 month.
15734494|NCT04989088|Device|ProComp5 Infiniti System w/BioGraph Infiniti Software|Left theta/beta NF training in combination with right beta/theta NF training in temporo-parietal regions, for 40 minutes (with a 20-minute break period)
15734495|NCT04989088|Device|ProComp5 Infiniti System w/recorded videos|Sham NF training using pre-recorded videos, for 40 minutes (with a 20-minute break period)
15734496|NCT04989075|Other|Oral prophylactic intervention|The oral prophylactic intervention will consist of the provision of specific package including a soft-bristled manual toothbrush, toothpaste, and a kit of calibrated interdental brushes (IDBs)(Curaprox CPS; Curaden) of sizes corresponding to the diameter of their interdental spaces. The participants will be instructed to brush their teeeth twice-daily and to realise a daily interdental brushing until delivery. The instructions for the use of the toothbrush and IDBs comprised verbal instructions supported by practical demonstration. The first use of the material will be conducted under the supervision of a qualified public health professor.
15734497|NCT04989062|Diagnostic Test|Fibroscan|Controlled attenuation parameter and liver stiffness measurement are measured.
15734498|NCT04989062|Diagnostic Test|Bioelectrical impedance analysis|Body composition measures including fat mass, fat-free mass, percentage body fat in total body and body segments are obtained.
15734499|NCT04989062|Diagnostic Test|Urine unclear magnetic resonance metabolomics|Metabolites in the urine are estimated by 600 MHz nuclear magnetic resonance.
15734500|NCT04989062|Diagnostic Test|Hand grip strength|Hand grip strength in both hands is measured by hand-held dynamometer.
15734501|NCT04989049|Drug|Folic Acid 5 MG|folic acid tablet of 5mg will be placed on the ulcers 2 times per day for 7 days
15734502|NCT04989049|Other|placebo|an inactive drug looking exactly like active drug will be given, patients will be asked to put it on ulcers 2 times per day
15734503|NCT04989036|Procedure|pulpotomy|Pulpotomy refers to the removal of the entire coronal pulp to the level of the root canal orifice(s) or as much as 2-3 mm apical to the orifices. Pulpotomy has indications similar to those of a partial pulpotomy except that the pulp in question is likely to have more extensive inflammation. Since pulpal inflammation is unlikely to extend past the canal orifices, pulpotomy is similar to a partial pulpotomy except that the entire mass of coronal pulp tissue is removed
15734504|NCT04989023|Other|Blood flow restriction (BFR) with low load resistance training|Combination of low load resistance exercise in the upper or lower limb with the addition of blood flow restriction or sham-blood flow restriction.
15734505|NCT04989010|Drug|89Zr-NY005|89Zr-NY005 injection followed by 89Zr-NY005 PET scan
15734506|NCT04988997|Drug|Vurolenatide 50mg/PBO|Vurolenatide - 50 mg biweekly SC administration, PBO alternate weeks
15734507|NCT04988997|Drug|Vurolenatide 100mg/PBO|Vurolenatide - 100 mg biweekly SC administration, PBO alternate weeks
15734508|NCT04988997|Drug|Vurolenatide 50/50 mg|Vurolenatide - 50 mg weekly SC administration
15734509|NCT04988997|Drug|Placebo|PBO - weekly SC administration
15734510|NCT04988971|Drug|a compound glutamine capsule|A compound glutamine capsule was taken orally from the first day of chemotherapy, orally 3 times a day after meals, 3 tablets each time, the course of treatment is 3 weeks.
15734511|NCT04988971|Drug|a compound glutamine capsule simulated placebo|a compound glutamine capsule simulated placebo was taken orally from the first day of chemotherapy, orally 3 times a day after meals, 3 tablets each time, the course of treatment is 3 weeks.
15734512|NCT04988958|Procedure|hydatid cyst resection|radical resection of hydatic cyst
15734513|NCT04988945|Procedure|TACE|Procedure of TACE will be standardized.
15734514|NCT04988945|Radiation|SBRT|SBRT screening and planning will be performed by radiation therapists, medical physicists, and oncologists.
15734515|NCT04988945|Drug|Durvalumab|1500mg Durvalumab administered IV over 60 minutes on Day 1 of each immunotherapy treatment every 4 weeks until disease progression (PD)
15734516|NCT04988945|Drug|Tremelimumab|300mg Tremelimumab administered over 60 minutes on Day 1 of cycle 1.
15734517|NCT04988932|Drug|Inhaled nitric oxide|Each increase of iNO dose is followed by a 10-minute monitoring period and a DSA examination. After reaching the highest effective dose of iNO or the maximum of 40 ppm another DSA is performed. iNO is going to be continued until normalisation of CVS or for a maximum period of 5 days. During iNO treatment a DSA will be performed every 24 hours, followed by a decrease of iNO to the next-lower level. If tapering the iNO concentration is associated with increasing vasospasm, iNO is going to be increased again to the last effective dosage. For cessation of iNO administration, dosage will be tapered every 30 minutes using the same dosage steps as for initiation of iNO treatment. If the duration of iNO treatment will be more than 32 hours, tapering intervals are prolonged to 4 hours. Cessation of iNO will be followed by a DSA.
15734518|NCT04988919|Dietary Supplement|4D|multi-ingredient supplement mixed with 24 ounces of water
15734519|NCT04988919|Dietary Supplement|placebo|taste-matched placebo mixed with 24 ounces of water
15734520|NCT04988906|Device|Zoll Accuvent Ventilation Monitor|Provides real-time ventilation quality monitoring (rate and volume)
15734691|NCT04987463|Drug|Rapamycin|Rapamycin in liquid administered orally, in the morning, every other day or daily depending on the patient's body weight. The starting dose of rapamycin will be calculated according to the body weight of the patient measured at V1.
15735314|NCT04982354|Drug|Fludarabine|25 mg/m2/day x 5 doses administered intravenously
15734521|NCT04988880|Other|Multiple Sclerosis Expert Patient Program of Catalonia|It is intended to constitute 12 groups of patients (6 with relapsing and 6 for progressive MS; one of each type per unit). The study will be conducted virtually due to the current pandemic situation. Throughout 9 sessions (1 per week for 9 sessions), participants in the group will share knowledge and lived experiences on all aspects related to MS and their self-management. In each session there is a theoretical part to focus on the topic, conducted by the EP. Immediately afterwards, the EP will encourage interaction, facilitating the expression of doubts, questions or experiences about the contents. Its resolution will be sought among the group, resulting in empowerment and control over the health situation. The knowledge acquired will be based on the information provided by the EP and on the knowledge resulting from the life experiences regarding MS of all the people involved. In all sessions, a healthcare professional will act as an observer, providing help and support to the EP.
15734523|NCT04988854|Behavioral|Facial expression video|Children are randomly allocated to one of three conditions: positive, neutral or no-food control, where they will watch either a positive, neutral, or no-food control video.
15734530|NCT04988828|Device|Whole body vibration|vertical vibration platform with the frequency of 30Hz, amplitude of 4mm. The intervention will last for 5 weeks, twice /week.
15734531|NCT04988815|Drug|Ropeginterferon alfa-2b|Eligible subjects will receive Ropeginterferon alfa-2b subcutaneously (SC) every 2 weeks at the starting dose of 250µg at week 0, 350 µg at week 2, then 500µg at a fixed dose from week 4 onwards
15734534|NCT04988789|Drug|Paclitaxel Drug Coated Balloon|Failing AVF/AVGs treated with Paclitaxel Drug Coated balloons are captured in this database
15734535|NCT04988776|Other|ultrasUltrasound-guided Intercostobrachial nerve block supplemental to supraclavicular block with 30 ml 0.25% bupivacaine (15 ml 0.5% bupivacaine will be added to 15 m|patients recieved ultrasound-guided Intercostobrachial nerve block with 10 ml 0.25% bupivacaine (5 ml 0.5% bupivacaine will be added to 5ml 0.9% normal saline ) supplemental to supraclavicular block with 30 ml 0.25% bupivacaine (15 ml 0.5% bupivacaine will be added to 15 ml of 0.9 %Nacl ) .
15734536|NCT04988776|Other|ultrasound-guided pectoral nerves block type II supplemental to supraclavicular block|Patients received ultrasound-guided pectoral nerves block type II with 10 ml 0.25% bupivacaine (5 ml 0.5% bupivacaine will be added to 5ml 0.9% normal saline ) supplemental to supraclavicular block with 30 ml 0.25% bupivacaine (15 ml 0.5% bupivacaine will be added to 15 ml of 0.9 %Nacl )
15734537|NCT04988763|Other|Opinions about tele-rehabilitation for consulting a clients with neurological impairments|Opinions about telerehabilitation for consultation purpose
15734538|NCT04988750|Device|NaviFUS System|Using the neuronavigator to precisely guide the ultrasound energy to brain tissues in real-time and intraoperatively.
15734539|NCT04988737|Other|Electronic Clinical Decision Support Application|Robust, real-time medication-related clinical decision support application for use in the operating room. The application is fully integrated with existing clinical systems. It provides visual alerts for medication errors and adverse medication events at the point-of-care.
15734540|NCT04988724|Behavioral|Exercise training|Exercise training with aerobic and strength training, 30 min per session
15734541|NCT04988711|Diagnostic Test|Hb Oxymeter|Measurement of Hb Oximeter
15734542|NCT04988698|Other|none intervention|none intervention
15734543|NCT04988685|Device|Sirolimus Eluting Balloon|PTCA with either a Sirolimus eluting balloon or Paclitaxel eluting balloon
15734544|NCT04988659|Other|Exposures|Exposures
15734545|NCT04988646|Drug|Acyclovir 200 MG|Administered with 240 mL of water
15734546|NCT04988646|Drug|Acyclovir 400 MG|Administered with 240 mL of water
15734547|NCT04988646|Drug|Zovirax 200 MG Tablet|Administered with 240 mL of water
15734548|NCT04988646|Drug|Zovirax 400 MG Tablet|Administered with 240 mL of water
15734549|NCT04988633|Behavioral|Intervention CFG App|Online healthy lifestyle education through an App. The intervention will consist of viewing educational videos on diet and exercise through an App. Videos will be uploaded to the app on a weekly basis, lasting 2-3.
15734550|NCT04988633|Behavioral|Control Group|Standard tips for healthy lifestyles that are carried out in regular Primary Care practice. After day 1, where standard advice is received, follow-up visits are conducted at week 2, week 4, month 3, and month 6.
15734551|NCT04988620|Other|Whole Blood transfusion|In this study the effect of storage time of whole blood will be investigated. Intervention is storage of whole blood.
15734552|NCT04988607|Drug|Osimertinib|osimertinib plus bevacizumab arm is dosed at osimertinib 80 mg orally once every day combined with bevacizumab 15mg/kg by intravenous drip infusion on day 1 of a 21-day (within 3 days) cycle
15734553|NCT04988607|Drug|Bevacizumab|osimertinib plus bevacizumab arm is dosed at osimertinib 80 mg orally once every day combined with bevacizumab 15mg/kg by intravenous drip infusion on day 1 of a
15734554|NCT04988607|Drug|Osimertinib|Osimertinib is dosed orally at 80 mg once per day
15734555|NCT04988594|Dietary Supplement|Lactobacillus acidophilus 207, Bifidobacterium lactis B420/205|Cultures containing 3.7 × 10 ^ 9 CFU/mg
15734556|NCT04988594|Dietary Supplement|Lactobacillus bulgaricus and Streptococcus thermophillus|Cultures containing 3.7 × 10 ^ 6 CFU/mg
15734557|NCT04988594|Dietary Supplement|No culture|No probiotic cultures
15735274|NCT04982653|Procedure|Surgical Procedure|Undergo hepatectomy using small bites fascial method for abdominal wall closure
15734558|NCT04988581|Other|Intensively integrated care of microvascular risk factors in the intervention group|The intensively integrated care, which will provide a standardized, combined, multi-component intervention according to clinical guideline treatment for diabetes and comorbidities in a primary care setting, will be delivered by trained primary care physicians, health managers and diabetes specialists. Diabetic microvascular risk factors (glycated hemoglobin [HbA1C], urinary albumin-to-creatinine ratio [ACR], blood pressure [BP], estimated glomerular filtration rate [eGFR], uric acid [UA] and low-density lipoprotein cholesterol [LDL]) will be tested every 3 month for the intervention group and clinical treatment decisions based on the test results will be implemented accordingly when necessary. The intensively integrated care intervention will last for 36 months. HbA1C, ACR, BP, eGFR, UA, LDL, other variables and co-morbidities will be measured at baseline and follow-up visits every 3 month.
15734559|NCT04988568|Other|None. This is a qualitative interview study.|There is no intervention in this study. This is a qualitative research study where patients will be interviewed.
15734560|NCT04988555|Drug|DSP-5336|DSP-5336 orally
15734561|NCT04988542|Dietary Supplement|Circadian Wellness sleep SL strip|Participants in the intervention group will be asked to begin Circadian Wellness sleep SL strip nightly for 30 days. Participants will continue the supplementation for the 30 days.
15734562|NCT04988529|Behavioral|Smartphone-based serious game intervention|Smartphone-based serious game intervention consists in the use of a serious game designed specifically to improve depressive symptoms. The psychological content consists of CBT intervention with the following psychotherapeutic components: Motivation for change, Psychoeducation, Cognitive Flexibility, Behavioural Activation, and positive psychotherapeutic strategies. To encourage physical activity, the serious game incorporates a mixed reality through physical activities such as taking a walk in real life affects aspects inside the game.
15734563|NCT04988516|Device|Virtual reality|Virtual reality goggles and a video game (Imagine) developed by PaperPlane Therapeutics will be used. It is an interactive game that presents to the child the process of an MRI by slowly introducing every steps when inside an MRI.
15734564|NCT04988516|Other|Standard protocol|MRI technicians will use the standard treatment normally used to help reduce anxiety that is to explain to the child the procedure for an MRI.
15734565|NCT04988503|Device|Coil embolization|coil embolization for ruptured intracranial aneurysm with bare platinum coils or second-generation hydrogel coils
15734566|NCT04988477|Behavioral|Chronic care management|Quarterly brief provider intervention (the 5As) and 3 quarterly outreach calls over 3 months.
15734567|NCT04988464|Behavioral|Sleep Scholar|A single-session, internet-based insomnia intervention for college students
15734568|NCT04988464|Behavioral|Building Healthy Habits|A single-session, self-guided, internet-based intervention focused on healthy eating and exercise
15734569|NCT04988451|Behavioral|ASL Services|ASL specialist meets with participants and provides ASL instruction
15734570|NCT04988425|Drug|TNFα Monoclonal Antibody|Subcutaneous injection of 50mg of TNFα monoclonal antibody immediately after admission before surgery.
15734571|NCT04988425|Drug|Methylprednisolone|Injection of 500mg of methylprednisolone immediately after admission before surgery.
15734572|NCT04988425|Drug|Saline|Injection of the same volume of saline immediately after admission before surgery
15734573|NCT04988412|Dietary Supplement|Investigational product 1|Test group 1 will receive investigational product 1 containing collagen (5 g/ 25 mL), MSM (1.5 g/ 25 mL) and vitamin C (80 mg/ 25 mL); continuous administration of investigational product for 12 weeks.
15734574|NCT04988412|Dietary Supplement|Placebo syrup|Placebo group will receive placebo syrup without active ingredients. (daily dose 25 mL: collagen: 0 mg, MSM: 0 mg, vitamin C: 0 mg; continous administration of placebo product for 12 weeks.
15734575|NCT04988412|Dietary Supplement|Investigational product 2|Test group 2 will receive investigational product 2 containing collagen (10 g/ 25 mL) and vitamin C (80 mg/ 25 mL); continuous administration of investigational product for 12 weeks.
15734576|NCT04988412|Dietary Supplement|Investigational product 3|Test group 3 will receive investigational product 3 containing collagen (10 g/ 25 mL), MSM (1.5 g/ 25 mL) and vitamin C (80 mg/ 25 mL); continuous administration of investigational product for 12 weeks.
15734577|NCT04988399|Other|Reiki|Reiki is a wellness practice of energy healing that began in Japan and is now practiced throughout the world. The principle of Reiki is that everything in the universe consists of energy including the human body, and deviations of this energy can lead to disease (Doğan 2018). Reiki does not have a religious doctrine and is accepted by people of all backgrounds and belief systems (McManus, 2017, p. 1056). Reiki is considered by practitioners to be a great tool for stress reduction and relaxation (International Association of Reiki Practitioners). Many people use Reiki for wellness. Reiki is not a cure for a disease or illness, but it may assist the body in creating an environment to facilitate healing. According to the Center for Reiki Research, Reiki is an effective approach for reducing pain, depression, and anxiety. Tinnitus is a pain percept, and it is likely Reiki may reduce pain and anxiety in patients with tinnitus.
15734578|NCT04988386|Drug|Acoramidis (AG10)|Acoramidis (AG10) twice daily
15734579|NCT04988373|Device|Modified aligner appliance|Patients will be treated using a single aligner appliance with NiTi Springs in order to align their crowding teeth.
15734580|NCT04988373|Device|Traditional fixed appliance|Patients will undergo typical orthodontic treatment using an MBT-prescription of metallic brackets.
15734581|NCT04988360|Device|HMD: Immersive VR|"Participants with dementia will view 360-degree films using a commercially-available Virtual Reality head mounted display (HMD) that has built-in speakers. While wearing the HMD, participants with dementia will be able to visually explore the virtual environments by turning their head to face different directions. Caregivers-participants will take part in the VR experience concurrently by viewing a tablet that is connected to the HMD through the screen mirroring function."
15734582|NCT04988360|Device|Tablet: Non-immersive VR|Participants with dementia will view 360-degree films on a commercially-available tablet that has built-in speakers. Participants with dementia will be able to visually explore the virtual environment using the touch screen (dragging the view around with one's finger). Caregiver-participants will take part in the VR experience concurrently by viewing the tablet while sitting or standing beside the participant with dementia.
15734583|NCT04988347|Combination Product|Spirulina platensis|Active treatment with Spirulina platensis in capsules containing 530 mg, 1 capsule orally each 8 hours, for 60 days
15734584|NCT04988347|Other|Placebo comparator|Placebo in capsules, 1 capsule orally each 8 hours, for 60 days
15734586|NCT04988321|Procedure|Prolonged continuous theta burst stimulation (pcTBS)|Non-invasive brain stimulation (transcranial magnetic stimulation or TMS) which consists of a stimulating coil being held over the head. When this coil delivers a painless magnetic pulse, it feels like a quick, light tap on the head. Two different coils will be used to perform TMS. One coil will be used to determine stimulation parameters for the pcTBS protocol. The second coil will be used to implement pcTBS, which is a repetitive non-invasive brain stimulation protocol which feels like many quick, light taps on the head. Participants will receive two procedures during one session, one with active stimulation and one with inactive stimulation.
15734590|NCT04988295|Drug|Lazertinib|Lazertinib will be administered orally.
15734591|NCT04988295|Drug|Amivantamab|Amivantamab will be administered as an IV infusion.
15734592|NCT04988295|Drug|Pemetrexed|Pemetrexed will be administered as an IV infusion.
15734593|NCT04988295|Drug|Carboplatin|Carboplatin will be administered as an IV infusion.
15734594|NCT04988282|Drug|Methylprednisolone Tablet|Methylprednisolone, oral, 0.5 mg/kg/day, 4 weeks
15734595|NCT04988269|Diagnostic Test|Blood sampling|Assessment of circulating levels of plasma ACTH, plasma aldosterone and serum interleukin -6 levels at day 1
15734596|NCT04988269|Diagnostic Test|Saliva sampling|Assessment of diurnal variation of cortisol and DHEA levels in the saliva at 4 different time points during the day (0.800, 12.00, 18.00, 22.00) at day 2.
15734597|NCT04988256|Drug|Cyclosporine|"Patients randomized to cyclosporine will be treated as mentioned under Arm/Group Description"
15734598|NCT04988256|Drug|Methylprednisolone and Prednisone|All patients randomized to steroids will initially be treated with IV methylprednisolone and eventually started on an oral prednisone taper.
15734599|NCT04988243|Other|All aortic valve products on the market|"Subjects with severe aortic valve stenosis
~Subjects who plan (or have) to use the transcatheter aortic valve replacement system for percutaneous aortic valve replacement
~The patients agreed to join the study, voluntarily signed the informed consent and completed the follow-up;
~Be able to contact the subjects or their legal guardians / relatives;
~The medical record records the subjects who have died and can't get any contact information of the subjects（ (for dead cases only)
~Sign the informed consent form, then check the inclusion and exclusion criteria, register after meeting the criteria, obtain the registration number, perform aortic valve replacement surgery, follow-up 24 hours, discharge, 30 days, 1 year, 2 years, 3 years, 4 years and 5 years after operation according to the test requirements, and carry out relevant follow-up according to the scheme requirements to collect data"
15734600|NCT04988230|Behavioral|Time restricted feeding|Participants will receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women during a window of 8 h/d (8 am to 4 pm).
15734601|NCT04988230|Behavioral|Continuous Energy Restriction|Participants will follow receive a diet of 1500-1800kcal/ d for men and 1200-1500kcal/d for women, without restriction on feeding time.
15734602|NCT04988217|Drug|Interferon-Alpha2B|Nebulized interferon alpha 2B
15734603|NCT04988217|Drug|Placebo|Nebulized placebo
15734604|NCT04988204|Behavioral|Diabetes Prevention Program|The Diabetes Prevention Program is a 1 year validated program to prevent the development of type 2 diabetes. Participants with NAFLD will engage will work with a CDC certified DPP certified lifestyle coach and other participants in a group setting during the study focusing on lifestyle changes to achieve weight loss and improvement in NAFLD.
15734605|NCT04988191|Drug|Toripalimab|"Neoadjuvant therapy: Toripalimab is given by intravenous infusion at 3mg/kg d1 every 2 weeks for 3 cycles.
~Adjuvant therapy: Toripalimab is given by intravenous infusion at a dose of 240mg every 3 weeks for up to 9 cycles."
15734606|NCT04988191|Drug|Bevacizumab|Neoadjuvant therapy: Bevacizumab is given by intravenous infusion at 5mg/kg d1 every 2 weeks for 3 cycles.
15734607|NCT04988191|Drug|Irinotecan|Neoadjuvant therapy: Irinotecan is given by intravenous infusion at 180mg/m2 d1 every 2 weeks for 2 cycles.
15734608|NCT04988178|Other|Data extraction from medical files|Data extraction from medical files
15734609|NCT04988165|Drug|Traditional Chinese Medicine|It is a common prescription used in traditional Chinese medicine to treat diarrhea with remarkable efficacy.
15734614|NCT04988139|Other|individualized educational training|50 min per session, one session per week, 4 sessions per month, of individualized educational training to preschool children with developmental delays under traditional rehabilitation programs
15734615|NCT04988126|Other|Interventions|Observational study, not applicable
15734616|NCT04988100|Procedure|splenic artery ligation|Splenic artery will be ligated just after takeoff from coeliac trunk at the level of body of pancreas
15734617|NCT04988100|Procedure|No intervention|Splenic artery is not ligated despite the presence of portal hyperperfusion
15734618|NCT04988087|Drug|MHV370|MHV370 for 24 weeks
15734619|NCT04988087|Drug|Placebo|Placebo for 24 weeks
15734620|NCT04988074|Drug|Cemiplimab|Cemiplimab for 9 weeks +/- Carboplatin + Paclitaxel
15734621|NCT04988061|Other|counselling|Educating and Counselling with personal communication for 10-15 minutes and written information about the importance of early identification and intervention for hearing loss are provided by a physician. Also, the information about hearing screening results and an appointment date are provided by a physician.
15734652|NCT04987814|Radiation|Biphotonic X-ray absorptiometry|Dual X-ray absorptiometry (DEXA) is considered the most effective procedure to date for assessing muscle mass and confirming the diagnosis of sarcopenia. DEXA is the same examination as bone densitometry (to assess osteoporosis) and through body composition analysis, it measures skeletal muscle mass index (SMMI in kg/m2, skeletal muscle mass/height2), percentage of muscle mass, fat mass and fat distribution (android/gynoid). Whole-body DEXA measurement is fast (3-10 minutes depending on the device), non-invasive, accurate, and minimally technician dependent. It induces an irradiation of 2-5 µSv, which is low compared to the daily natural irradiation (5-7 µSv).
15751803|NCT04845035|Drug|Methotrexate and Cytarabine|Intrathecal
15734622|NCT04988048|Biological|COVID-19 vaccines|"Gam-COVID-Vac Gamaleya National Center for Epidemiology and Microbiology - Russia. Non-replicative viral vector. Multi-dose vial (5 doses in 3 mL) Single-dose vial (1 dose in 0.5 mL). Intramuscular T° less than -18 ° C
~BBIBP-CorV Beijing Institute of Biological Products - People's Republic of China. Inactivated viruses. Single-dose vials (1 dose in 0.5 mL) or multi-dose vial (2 doses per vial). Intramuscular T° 2 to 8 ° C
~ChAdOx1 nCoV-19 vaccine AZD1222 AstraZeneca-Oxford - United Kingdom. Non-replicative viral vector. Multi-dose vial (10 doses in 5 mL). Intramuscular T°: 2 to 8 ° C
~mRNA-1273 or Spikevax Moderna Switzerland GmbH and the National Institute of Allergy and Infectious Diseases (NIAID) of the United States. mRNA. Multi-dose vial (maximum 15 doses per 0.5ml vial). Intramuscular. T°-15 ° to -50 °"
15734626|NCT04988022|Drug|Dupilumab|300 mg prefilled syringe
15734627|NCT04988022|Drug|Placebo|Matching placebo
15734628|NCT04988009|Other|Electronic Health Record Review|Review of medical chart
15734629|NCT04988009|Other|Survey Administration|Complete survey
15734630|NCT04987996|Drug|GR-MD-02|Patients will receive up to seventeen doses of GR-MD-02 intravenously over 85 Days.
15734631|NCT04987996|Drug|Placebo|Patients will receive up to seventeen doses of placebo intravenously over 85 Days.
15734632|NCT04987996|Drug|Pembrolizumab|Patients will receive 200mg doses of pembrolizumab intravenously over 85 Days.
15734633|NCT04987983|Other|Experimental SLP-R|SLP-R will be given to the infant during bottle-feeding.
15734634|NCT04987983|Other|Experimental SLP-L|SLP-L will be given to the infant during bottle-feeding.
15734635|NCT04987970|Drug|CKD-386(2)|QD, PO
15734636|NCT04987970|Drug|D013, D326, D337|QD, PO
15734637|NCT04987957|Other|Music Therapy|Classical Music, Turkish Classical Music, Turkish Folk Music and Sufi Music
15734640|NCT04987931|Drug|Talazoparib|This retrospective chart review study focuses on patients with HER2- ABC with gBRCA1/2m initiating talazoparib on or after October 16, 2018 and ≥18 years of age at initiation of talazoparib.
15734641|NCT04987918|Diagnostic Test|Applied Biosystems TaqPath COVID- 19 Combo Kit|Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)
15734642|NCT04987905|Other|Mindfulness|"In the study, for 60 minutes once a week for 8 weeks MIND-BE program will be applied to nurses. The program includes formal and informal practices of mindfulness (Getting started, Introduction to MIND-BE, Noticing the autopilot, Power of attention, Simple awareness, Eating awareness, Body awareness, Breath awareness, Sitting awareness, Stress and reactions, Vision awareness, Challenging emotions and situations in business life, Awareness in business life, Awareness and communication, Awareness and compassion, Developing your own practice)."
15734643|NCT04987892|Device|UroLift System|Prostatic lift
15734644|NCT04987892|Drug|Tamsulosin Hydrochloride|Tamsulosin HCl 0.4mg
15734645|NCT04987879|Behavioral|Exercise|Aerobic exercise can be completed by walking, jogging or running or by using cardio equipment (e.g., recumbent bike). Each session will begin with a warm-up with walking (30-40% target HR for 5-min) and dynamic exercises (knee-to-chest, 10-yd lateral shuffle, bent over twist, calf sweeps, leg swings). A 5-min walking cool down will end the session (30-40% target HR).
15734646|NCT04987866|Device|vibration device , Beauty bar facial massaging device, T-Shape Electric Sign Face Massage Tools, Dangshan, China|The vibration device is a reusable, handheld device with a battery-powered motor and a vibration frequency of approximately 6000 times per minute (Beauty bar facial massaging device, T-Shape Electric Sign Face Massage Tools, Dangshan, China)
15734647|NCT04987853|Diagnostic Test|Clinical and functional analysis|"General blood analysis - Complete blood count on an analyzer with differentiation of 5 classes of cells, the ratio of neutrophils to lymphocytes; Blood chemistry - ALT, AST, total bilirubin, direct, LDH, CRP, alpha-amylase, creatinine, urea, glucose, ferritin, glycosylated hemoglobin, vitamin 25 - OH vitamin D, vitamin B12; Coagulogram - D-dimers, fibrinogen, INR, APTT; Other - NT-pro BNP, Homocysteine, IL 6, Troponin, blood group determination; Linked immunosorbent assay - Determination of IgG and IgM antibodies to SARS-CoV-2 coronavirus (COVID-19) in blood serum, RBD; Functional diagnostics • ECG
~EchoCG + strain
~CT scan of the lungs
~Holter
~SMAD
~Kidney ultrasound
~Ultrasound
~Doppler ultrasonography of veins and arteries
~Chalder Scale, EQ Questionnaire"
15734648|NCT04987853|Diagnostic Test|Neurological analysis|"Neurological examination with the isolation of neurological syndromes (motor, cognitive impairments, sleep disorders, asthenic-depressive syndromes, etc.).
~2. Neuropsychological methods - research on the scales of anxiety and depression, MMSE, etc.
~3. Instrumental method - EEG, polysonography, ultrasound of the neck vessels, CT perfusion.
~4. Laboratory research methods:
~The study of antibodies to some neurospecific antigens - myelin basic protein (MBP), neurospecific enolase (NSE).
~Study of cellular immunity (CD3 +, CD4 +, CD8 +) and general indicators of humoral immunity (IgG, IgA, IgM, circulating immune complexes)."
15734649|NCT04987853|Diagnostic Test|Immunological analysis:|A comprehensive immunological analysis will be carried out to determine the level of the immune response. Calculation of the level of CD4 +, CD8 + and NK cells. The level of antibodies of the IgG and IgM classes to the proteins of the coronavirus S1, RBD and N was determined
15734650|NCT04987853|Diagnostic Test|Genetic analysis:|Isolation (extraction) of DNA will be performed from whole blood using commercial kits according to the manufacturer's instructions. To analyze a large number of genetic markers, it is planned to carry out genome-wide sequencing followed by analysis of genetic polymorphisms of candidate genes encoding coronavirus receptors and immunological factors.
15734651|NCT04987827|Other|No intervention|No intervention
15734653|NCT04987801|Other|Drug Toxicity|Patients who took over dose of Drugs
15734692|NCT04987463|Drug|Placebo|Placebo in liquid administered orally, once daily, in the morning. The starting dose of placebo in liquid will be calculated according to the body weight of the patient measured at V1.
15734693|NCT04987463|Drug|Placebo|Placebo in granules administered orally, initially once daily in the evening,and after reaching the targeted dose administered two times daily.
15734654|NCT04987788|Behavioral|Motívate|The Motívate app can be used in English or Spanish and involves four sequential phases. 1) The engaging phase uses videos to welcome participants. 2) Patients willing to discuss the decision to have a screening colonoscopy will answer multiple-choice questions on colorectal cancer prevention - completing the focusing phase. Optional videos will offer additional information. 3) The evoking phase consists of interactive Motivational Interviewing exercises to help participants elicit motivations to get a screening colonoscopy. 4) During the planning phase, participants will view a video that will discuss the steps needed to prepare for the colonoscopy.
15734655|NCT04987788|Behavioral|Video link|General health information video link
15734656|NCT04987775|Drug|N-Acetyl Cysteine|900mg 2x daily
15734657|NCT04987775|Drug|Placebo|Matching placebo bid
15734659|NCT04987749|Device|intermittent theta burst stimulation|stimulatory protocol
15734660|NCT04987736|Diagnostic Test|RT-PCR|COVID 19 diagonostic test
15734661|NCT04987723|Other|Holter monitoring|Assessment of HRV shall be performed in all enrolled patients. Ventricular HRV will be derived from a continuous 24-hour period of a 48-hour ambulatory Holter recording during AF. Participants will be requested to avoid alcohol and caffeine from 24-hours prior to fitting and any activity more strenuous than walking for the recording duration. After initial fitting, a 20-minute high-resolution ECG recording will be performed lying supine at rest.
15734662|NCT04987723|Other|stress echocardiography|Echocardiography will be performed using a GE Vivid 9 echocardiography machine (Vingmed-General Electric, Horten, Norway) equipped with a phased-array 3.5 MHz transducer. All measurements will be made according to the guidelines set by the British Society of Echocardiography.
15734663|NCT04987723|Other|Cardiac MRI|Contraindications to MRI will be excluded using the appropriate departmental screening forms. A trained scanner operator or radiographer will co-ordinate and supervise the scan. Cardiac MRI will be performed at 1.5T (Aera, Siemens Healthineers, Erlangen, Germany) with a protocol consisting of cine imaging, stress and rest perfusion, and late gadolinium enhancement (LGE).
15734664|NCT04987723|Other|Patient questionnaires|Two validated Health Related Quality of Life (HRQoL) surveys designed for patients with AF will be used; the AF Effect on Quality of Life (AFEQT) and Barts AF Patient reported objective measure (PROM).
15734665|NCT04987710|Device|intracranial rescue stenting|use of intracranial rescue stenting as re-perfusion technique after failed thrombectomy
15734666|NCT04987697|Behavioral|counseling|nine 90-minute weekly psychoeducational group sessions facilitated by a licensed mental health counselor (LMHC).
15734667|NCT04987684|Diagnostic Test|SCINSEV and PECAP|To measure PECAP and SCINSEVs. To find whether electrodes are outside of the cochlear or within dead regions within the cochlear.
15734669|NCT04987658|Drug|OLZ/SAM|Olanzapine and Samidorphan taken once daily over a max period of 21 days
15734670|NCT04987645|Procedure|Water-only infusion technique|During a routine colonoscopy, a resident in the study will use water only infusion technique for this intervention. This intervention is used to look at the impact that water assisted colonoscopy has on resident learning.
15734671|NCT04987645|Procedure|Water infusion and air insufflation|During a routine colonoscopy, a resident in the study will use water infusion and air insufflation technique for this intervention. This intervention is used to look at the impact that water assisted colonoscopy has on resident learning.
15734672|NCT04987632|Drug|Letrozole|Letrozole, an aromatase inhibitor, is considered to be the first-line drug for ovulation induction in PCOS.
15734673|NCT04987632|Device|acupuncture|Domestic and foreign studies suggest that acupuncture and electroacupuncture can improve the menstrual cycle of PCOS and reduce the level of total testosterone; Acupuncture can regulate glucose homeostasis by stimulating the autonomic nervous system of PCOS patients. Our previous studies and a large number of literatures have proved that acupuncture can improve insulin resistance in PCOS, and acupuncture can improve the pregnancy rate in PCOS.
15734674|NCT04987632|Other|Governor vessel moxibustion|It can warm the kidney, promote digestion and absorption, remove dampness and promote blood circulation
15734675|NCT04987619|Dietary Supplement|Beetroot juice|Subjects will drink juice 120 minutes before each visit
15734676|NCT04987619|Other|Capri-Sun|70 mL of blackcurrant beverage, which is depleted of NO3- will be taken 120 min before each visit.
15734677|NCT04987593|Dietary Supplement|Probiotics|Once a day daily intake of probiotics, at least for 28 consecutive days before giving birth and for at least 28 consecutive days after giving birth
15734678|NCT04987567|Dietary Supplement|ANTIOXIDANT DHA TRIGLYCERIDE (TRIDOCOSAHEXAENOINE-AOX®)|Pearls of DHA (BrudyNen)
15734679|NCT04987567|Dietary Supplement|PLACEBO (OLIVE OIL)|Pearls manufactured to mimic DHA (BrudyNen).
15734680|NCT04987554|Dietary Supplement|glycophosphopeptical AM3|3 g/day of AM3
15734681|NCT04987554|Other|Placebo|3 g/day of placebo
15734682|NCT04987541|Device|intermittent theta burst stimulation|stimulatory protocol
15734683|NCT04987528|Diagnostic Test|Aminoterminal type III peptide of procollagen|Serial Measurement of PIIINP in serum and/or BAL
15734684|NCT04987528|Diagnostic Test|Lung computed tomography|Screening for the presence of reticulation or bronchiectasia within lung parenchyma
15734685|NCT04987515|Procedure|fenestration decompression combined with stage II curettage|first，fenestration decompression was performed. then, patients return every 3 months for follow up. If the cystic cavity area was gradually reduced after 6 months of follow-up, patients should be considered for Ⅱ stage curettage surgery.
15734686|NCT04987502|Other|Virtual Reality|8 sessions of virtual reality with 3D audio and visual rendering
15734687|NCT04987502|Behavioral|Standard treatment|counselling, relaxation techniques, sound enrichment
15734688|NCT04987489|Drug|Etavopivat tablets|Etavopivat 400 mg once daily
15734689|NCT04987476|Biological|analyzes in singles cells|genome expression analyzes in single cells
15734690|NCT04987463|Drug|Vigabatrin|Vigabatrin in capsules administered orally, initially (between V1 and V2) once daily in the evening,and starting from V2 administered two times daily.
15734694|NCT04987450|Drug|Methylprednisolone, prednisone|The patients receive intravenous pulses of methylprednisolone 20-30 mg/kg/day for three consecutive days followed by oral prednisone 0.8-1.0 mg/kg/day.
15734696|NCT04987424|Diagnostic Test|Development and validation of Lymphedema levels diagnostic|A single intervention was carried out in which the patients were summoned for an interview and anthropometric measurements of the upper limbs, thus calculating the arm volume for a lymphedema primary diagnosis .
15734697|NCT04987411|Diagnostic Test|Measurement of methane concentrations in exhaled breath|To measure methane concentrations, a near-infrared laser technique-based photoacoustic apparatus will be attached to the exhalation outlet of the ventilator upon arrival of severely injured patients. Exhaled methane levels will be monitored continuously during the first 72 in-hospital hours and will be recorded at pre-determined time points (directly upon arrival, 6 hours post-admission, 12 hours post-admission, 24 hours post-admission, 48 hours post-admission and 72 hours post-admission).
15734698|NCT04987411|Diagnostic Test|Videomicroscopy of the sublingual microcirculation|Orthogonal polarization spectral imaging technique (Cytoscan A/R, Cytometrics) will be used to visualize the microcirculation of the sublingual mucosa of the patients. The OPS technique utilizes reflected, polarized light at the wavelength of the isobestic point of oxyhemoglobin and deoxyhemoglobin (548 nm). The diminution of sublingual microcirculation can refer to circulatory redistribution due to hemorrhage. Sublingual microcirculation of the patients will be visualized and evaluated at pre-determined time points (directly upon arrival, 6 hours post-admission, 12 hours post-admission, 24 hours post-admission, 48 hours post-admission and 72 hours post-admission) during the first 72 in-hospital hours.
15734699|NCT04987411|Diagnostic Test|Blood gas and laboratory analysis|Arterial blood gas analysis and laboratory testing of venous blood are routine examinations in clinical practice. Base deficit and lactate are considered as global markers of blood loss and shock, and can be obtained rapidly with blood gas analysis. Hemoglobin and hematocrit values can correspond to the severity of blood loss, and are measured routinely both from arterial and venous blood. Sampling of arterial and venous blood for blood gas and laboratory analyses will be performed at pre-determined time points (directly upon arrival, 24 hours post-admission, 48 hours post-admission and 72 hours post-admission) during the first 72 in-hospital hours.
15734700|NCT04987411|Diagnostic Test|Hemodynamic monitoring|Hemodynamic monitoring is an essential part of emergency trauma care. Non-invasive monitoring of blood pressure, heart rate and respiratory rate of patients will be started immediately upon arrival. After patients are stabilized, invasive arterial blood pressure (IABP) monitoring can be started. IABP is considered as the gold standard of blood pressure measurement in critical care as it reflects the fluctuations of blood pressure in real time. Blood pressure and heart rate values will be recorded at pre-determined time points (directly upon arrival, 6 hours post-admission, 12 hours post-admission, 24 hours post-admission, 48 hours post-admission and 72 hours post-admission) during the first 72 in-hospital hours.
15734701|NCT04987385|Dietary Supplement|Protein supplementation|Patients will receive a box with 7 sealable of 90-gram protein containers and will be instructed to consume 1 container mixed with 200ml of liquid every day for the following 7 days, while keeping their usual meal composition and usual fluid intake. A wash-out period of minimum 7 days between Protein supplementation and Oral urea will be performed.
15734702|NCT04987385|Dietary Supplement|Oral urea|Patients will receive a box with 7 30-grams urea sealable containers and will be instructed to consume 1 container mixed with 200ml of liquid every day for the following 7 days, while keeping their usual meal composition and usual fluid intake.
15734703|NCT04987372|Drug|Dexmedetomidine|The use of multimodal painkillers pre, per and postoperative
15734704|NCT04987359|Behavioral|Multimodal Lifestyle Program|The multimodal lifestyle program will utilize intensive behavioral therapy with structured exercise training and nutritional counseling.
15734705|NCT04987346|Other|Walking on an instrumented treadmill|Participants will be asked to walk at different gait velocities for 1 minute. The treadmill speed will be increased incrementally at 0.1m/s intervals until just before running.
15734706|NCT04987333|Drug|Efavaleukin alfa|Administered as a single dose SC injection.
15734707|NCT04987320|Drug|Olpasiran|Subcutaneous injection
15734708|NCT04987307|Drug|Efavaleukin alfa|Efavaleukin alfa will be administered by subcutaneous (SC) injection.
15734709|NCT04987307|Drug|Placebo|Placebo will be administered by SC injection.
15734710|NCT04987294|Drug|ALLN-346|ALLN-346 (Engineered Urate Oxidase) is an orally administered, novel urate oxidase; provided as capsules for oral administration
15734711|NCT04987294|Drug|Placebo|Matched placebo capsules are similar in weight and appearance to the ALLN-346 capsules
15734712|NCT04987281|Procedure|Computed Tomography|Undergo CT
15734713|NCT04987281|Drug|Indocyanine Green Solution|Given via injection
15734714|NCT04987281|Device|Therapeutic Bronchoscopy|Undergo bronchoscopy using Ion robotic bronchoscope
15734715|NCT04987268|Genetic|clonal hematopoiesis of indeterminate potential|Whole-exome sequencing is performed to detect the presence of clonal hematopoiesis of indeterminate potential (CHIP)
15734716|NCT04987255|Other|Free visit|The persons with sedentary (healthy) in this group will have to visit the museum freely (without a guide) for a period of 75 minutes.
15734717|NCT04987255|Other|Guided visit|The persons with sedentary (healthy) in this group will have to visit the museum with a guide for a period of 75 minutes.
15734718|NCT04987255|Other|Guided visit (stroke)|The persons with motor disability after stroke in this group will have to visit the museum with a guide for a period of 75 minutes.
15734719|NCT04987242|Drug|ALLN-346|ALLN-346 (Engineered Urate Oxidase) is an orally administered, novel urate oxidase; provided as capsules for oral administration
15734720|NCT04987242|Drug|Placebo|Matched placebo capsules are similar in weight and appearance to the ALLN-346 capsules
15734722|NCT04987216|Device|IOL implantation experimental|Mono- or bilateral implantation of toric intraocular lenses PODEYE TORIC. If only one eye qualifies for toric lens implantation due to small amount of pre-existing corneal astigmatism, one eye will be implanted with PODEYE TORIC and the contralateral eye will be receive an implantation with the monofocal parent lens PODEYE (PhysIOL sa/nv, Liège, Belgium).
15734723|NCT04987203|Drug|Tivozanib|Tivozanib will be administered orally.
15734724|NCT04987203|Drug|Nivolumab|Nivolumab will be administered via intravenous infusion.
15734725|NCT04987190|Procedure|alveolar bone graft|alveolar bone graft with Scarpa fascia done when patients were at 9 year of age
15735275|NCT04982653|Procedure|Surgical Procedure|Undergo hepatectomy using conventional fascial method for abdominal wall closure
15734727|NCT04987164|Dietary Supplement|Feminabiane CBU|EXTRACTS OF CRANBERRY, CINNAMON AND MICROBIOTIC STRAINS
15734728|NCT04987151|Other|Experimental-Strength training|Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to strength training exercise involving the major muscle groups
15734729|NCT04987151|Other|Experimental-Aerobic training|Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to brisk walking.
15734730|NCT04987151|Other|Experimental-Strength/Aerobic training|Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching), 15 minutes are allocated to brisk walking and 25 minutes are allocated to strength training involving the major muscle groups.
15734733|NCT04987125|Behavioral|Dyspnea Neuroscience education|"Patients will follow an online therapeutic education course about dyspnea. Education about the cognitive and emotional aspects of dyspnea processing, with the goal of changing maladaptive cognitions and behaviors.
~The course will be group-based (5 participants). The frequency will be of 1 session per week for 4 weeks, each session will have a duration of 1 hour."
15734734|NCT04987125|Behavioral|Usual care|General health advice, physiotherapy treatment. The frequency will be of 1 session per week for 4 weeks, each session will have a duration of 1 hour.
15734735|NCT04987112|Drug|CAN1012|CAN1012 IT injection (once every 4 weeks)
15734736|NCT04987099|Dietary Supplement|550 mg/day Choline|Choline chloride (550 mg) is a water soluble choline salt that will be provided in a grape juice cocktail solution to participants for daily consumption.
15734737|NCT04987099|Dietary Supplement|25 mg/day Choline|Choline chloride (25 mg) is a water soluble choline salt that will be provided in a grape juice cocktail solution to participants for daily consumption.
15734738|NCT04987086|Diagnostic Test|PSMA PET|PSMA PET may have influence on the clinical decision-making of the patients with renal cancer
15734739|NCT04987073|Procedure|skin biopsy|A skin biopsy to cultivate fibroblasts.
15734740|NCT04987060|Device|Intrastromal Fresh Human Lenticule Implantation|The stromal pocket diameter was set 8.0 mm and cap thickness was set to 140 μm from corneal surface and a 2mm superior incision. Hinge position flap was set at 90°, angle 50° and width 4 mm, side cut angle 90°. The pocket was dissected using a blunt spatula washed with normal saline. The lenticule was held with lenticule forceps and gently inserted into the pocket through the 2 mm superior incision. Incision position changed according to the position of the highest K values.
15734741|NCT04987047|Biological|Blood collection|A blood sample will be collected at enrollment to perform pharmacogenetics analyses.
15734742|NCT04987047|Other|Questionnaires|Several questionnaires will be filled by the participants or by the clinicians at every study visits: Hospital anxiety depression scale (HAD), Post Traumatic Stress Disorder Checklist for DSM-5 (PCL-5), Quick inventory of depressive symptomatology - self rated (QiDS), Beck's Anxiety Inventory (BAI), World Health Organization Quality Of Life (WHOQOL-BREF), EuroQol Group questionnaire (EQ5D), Frequency, intensity, burden of side effects rating (FIBSER), Udvalg for Kliniske Undersøgelser - Side Effects Rating Scale - for Patients (UKU-SERS-PAT), Clinical Global impression (CGI), Montgomery and Asberg Depression Rating Scale (MADRS).
15734743|NCT04987047|Other|Cognitive test battery (optional)|"For patients participating in the ELAN ancillary study : the participants will undergo a battery of neurocognitive tests assessing vital impetus (élan vital in French)."
15734744|NCT04987034|Device|EchoTip® Insight™|Patients will undergo procedure where HVPG is obtained under mild sedation, next the patients will undergo anesthesia and mechanical intubation where HVPG measurements will be obtained simultaneously with the EchoTip Insight measurement. For patients receiving a transjugular intrahepatic portosystemic shunt (TIPS), direct portal vein pressure measurements will be obtained by the EchoTip® Insight™ and compared to the transjugular direct portal vein measurement obtained during the interventional radiology (IR) procedure.
15734746|NCT04986995|Drug|Opicapone|Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI
15734747|NCT04986982|Drug|Opicapone 50 mg|Opicapone (BIA 9-1067) 50 mg hard capsules. Oral administration, once daily, at least 1 hour before or after the last daily dose of levodopa (L-dopa) plus a dopa decarboxylase inhibitor (DDCI) (L-dopa/DDCI).
15734748|NCT04986982|Other|Matching placebo|Matching placebo hard capsules. Oral administration, once daily, at least 1 hour before or after the last daily dose of L-dopa/DDCI
15734749|NCT04986969|Behavioral|Online cognitive behavioral therapy|online cognitive behavioral therapy delivered using one of two active methods
15734750|NCT04986956|Dietary Supplement|Whole coffee cherry extract|200mg WCCE
15734751|NCT04986956|Dietary Supplement|Placebo|Placebo for comparison to WCCE
15734753|NCT04986930|Radiation|SBRT+mFOLFIRINOX|Stereotactic body radiotherapy: 3500 cGy (5 fractions) mFOLFIRINOX, every 2 weeks Oxaliplatin, 85 mg/m2, intravenous, day 1 Leucovorin, 400 mg/m2, intravenous, day 1 Irinotecan, 150 mg/m2, intravenous, day 1 fluorouracil, 2,400 mg/m2, intravenous, day 1-2
15734754|NCT04986930|Drug|mFOLFIRINOX|mFOLFIRINOX, every 2 weeks Oxaliplatin, 85 mg/m2, intravenous, day 1 Leucovorin, 400 mg/m2, intravenous, day 1 Irinotecan, 150 mg/m2, intravenous, day 1 fluorouracil, 2,400 mg/m2, intravenous, day 1-2
15734755|NCT04986917|Device|Hernia repair surgery using the Su2ura® approximation device|. The hernia defect will be measured and the Su2ura® approximation device will then be used to close the defect, placing stainless steel implantable anchors threaded on a Polyethylene braided surgical suture.
15734756|NCT04986917|Diagnostic Test|Physical Examination|All subjects will undergo a standard physical examination by an authorized physician. The physician's evaluation will include diagnosis and documentation of any significant clinical abnormalities or diseases.
15734757|NCT04986917|Diagnostic Test|Vital Signs|Vital signs include blood pressure, pulse, temperature, body weight and height, body mass index (BMI).
15734758|NCT04986917|Diagnostic Test|Blood Tests|"All subjects will undergo Hematology and Biochemistry blood tests. Blood Hematology test will include a complete CBC. Blood Biochemistry test will include the following measures: Sodium (Na), Potassium (K), Chloride (Cl), Creatinine, Glucose, Urea, Albumin, Calcium total, Alkaline Phosphatase (ALP), ALT, AST, Total Bilirubin, Direct Bilirubin, LDH, Total Protein, Uric Acid, CRP, and Lipid Profile (including Total Cholesterol, HDL, LDL, Triglycerides).
~5 ml of blood (equals to 1 spoon) will be taken for each test."
15734759|NCT04986917|Diagnostic Test|Urine Pregnancy Test|Urine pregnancy test will be performed during the screening visit (for WOCBP).
15734760|NCT04986917|Diagnostic Test|Abdominal Ultrasound imaging|All subjects will undergo an abdominal ultrasound (US) imaging at 12 Months visit. The US will be performed to verify an absence of hernia recurrence.
15734761|NCT04986917|Other|EuraHS-QoL|patients will be asked to fill a questionnaire assessing patient-reported satisfaction and function. questionnaire score range: 0-180; higher score indicates higher pain and discomfort
15734762|NCT04986917|Other|Visual Analouge Scale (VAS)|A validated, subjective measure measuring acute and chronic pain. questionnaire score range: 0-10; higher score indicates higher pain level.
15734763|NCT04986917|Diagnostic Test|Clinical evaluation for hernia recurrence and clinical bulging|"The procedure includes:
~Clinical examination to determine the presence of hernia recurrence and clinical bulging, in an inconclusive physical exam a radiological imaging will be performed such as US or CT.
~SAE's and SADE's evaluation of the seroma.
~Taking a photograph of the surgery area without disclosing the subject's identity."
15734764|NCT04986904|Behavioral|SHUTi (Sleep Healthy Using the Internet)|Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program
15734765|NCT04986878|Procedure|single-shot adductor canal block|An ultrasound machine (Philips; Model: OTD020, AcBel Polytech Inc., Taiwan) with a 5-10 MHz linear probe was used to perform the adductor canal block immediately postoperatively.
15734766|NCT04986865|Drug|ATG-101|ATG-101 will be administered intravenously once every 21 days. The dose levels will be determined by the starting dose and the escalation steps taken in the trial. The Dose Expansion Phase will begin at the defined MTD, RP2D, or biologically optimal dose.
15734767|NCT04986852|Drug|Olinvacimab|Treatment with Olinvacimab and Pembrolizumab is to be continued until disease progression, the development of unacceptable toxicity or patient's withdrawal of consent. Maximum duration of treatment will be 35 cycles (approximately 2 years).
15734770|NCT04986813|Drug|Tranexamic acid injection|1 g of TXA in 100 ml of normal saline
15734771|NCT04986813|Other|Normal Saline|100 ml
15734772|NCT04986800|Behavioral|PROACTIVE Parent|PROACTIVE Parent will educate parents about their child's mental health symptoms and treatment, how to talk to the child's therapist to support treatment goals at home and in the community. PROACTIVE Parent will teach parents the function of child behavior, the role of symptomatology in child behaviors, and strategies to promote effective behavior management and healthy coping. Parents will also learn skills to manage their own emotional dysregulation to promote calm parental responding and promote healthy parent-child interaction and communication.
15734773|NCT04986787|Device|tACS|a non-invasive brain stimulation technique that allows interaction with endogenous cortical oscillatory rhythms
15734774|NCT04986787|Device|TMS|a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain, it will be specifically cerebellar stimulation
15734775|NCT04986774|Procedure|Rescue intracranial stenting|Rescue Intracranial Stenting in Acute Ischemic Stroke caused by intracranial large vessel occlusion
15734776|NCT04986761|Procedure|Treatment of implant single crown|Digital or Conventional Workflows for treatment of implant single crown and materials used.
15734777|NCT04986735|Drug|Empagliflozin|All subjects will have a baseline assessment and be prospectively followed up for 52 weeks to examine their outcome after receiving empagliflozin for neutropenia and neutrophil dysfunction.
15734778|NCT04986709|Device|Open repair|Open repair of the aortic arch and descending aorta with or without involvment of the ascending aorta using a hybrid graft.
15734779|NCT04986696|Device|FLASH therapy|Dose escalation of high dose rate radiotherapy (FLASH therapy) as single dose treatment for skin melanoma metastases that progress locally despite systemic treatments.
15734780|NCT04986683|Diagnostic Test|Brain magnetic resonance imaging|Brain magnetic resonance imaging (MRI) will be done using multiple sequences to evaluate the presence, type, and severity of brain abnormalities in enrolled subjects.
15734781|NCT04986683|Behavioral|Neuro-psychology testing|Participants will undergo age-appropriate neuro-psychology testing to assess motor, language, and other neurocognitive functions potentially affected by drug-resistant epilepsy.
15734846|NCT04986163|Device|Non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDASENSE monitor|The patients are monitored with two monitors under anesthesia: one monitor attached to the left hand and one monitor to the right hand. When one monitor is connected to the patient, the other monitor will be disconnected. The first monitor is ANSPEC-PRO and the second monitor used is MEDASENSE.
15735276|NCT04982640|Behavioral|Iyengar yoga|60 minute group-classes of Iyengar yoga delivered twice weekly for 12 weeks
15734782|NCT04986670|Behavioral|Nutritional Counseling|Medical oncology providers will refer participants to oncology RDs for remotely-delivered motivational interviewing-based nutrition counseling to address participants individualized nutritional needs. After baseline visits, participants assigned to the NutriCare group will be contacted by a RD for a phone-based orientation where the RD will discuss nutrition assessment results, and assess participant values, ambivalence, readiness to change, and arrive at a mutually agreeable nutrition care plan. Participants will be contacted weekly during the first 6 months of the intervention (Active Phase) and contacted every other week during the next 2 months of the intervention (Maintenance Phase).
15734783|NCT04986670|Other|Medically Tailored Meals (MTMs)|Medically tailored meals will be provided to participants in the intervention group for a total of 24 weeks. During the first 8 weeks of the intervention, 3 meals/day will be provided each week for a total of 168 meals per participant. It will be followed by less frequent meal provision during the subsequent 16 weeks following this schedule: 3 meals/day will be provided every other week for the next 8 weeks (a total of 84 meals per participant); and 3 meals/day will be provided every four weeks during the last 8 weeks (a total of 42 meals per participant). Upon the completion of the meal provision, the RD team will continue providing nutrition counseling for another 8 weeks that aims to promote self-efficacy in home meal preparation and adherence to the evidence-based dietary pattern guidelines.
15734784|NCT04986670|Behavioral|Nutrition Prescription|Oncology providers will advise participants with lung cancer to follow evidence-based nutrition recommendations using a Nutrition Prescription. The Nutrition Prescription aims to enhance providers' role in communicating basic nutrition advice to participants with lung cancer. It contains seven recommendations, adapted from the newly released Cancer Prevention Recommendations by WCRF/AICR with strong evidence-base.
15734785|NCT04986670|Other|Nutrition Assessment|Oncology care providers will assess the nutritional status of patients with lung cancer using PG-SGA Short Form (the Scored Patient-Generated Subjective Global Assessment). PG-SGA is an interdisciplinary patient assessment in oncology and other chronic catabolic conditions. The short form contains four patient generated historical components (weight history, food intake symptoms, and activities and function).
15734786|NCT04986670|Behavioral|Nutrition Toolkit|Patients will receive a printed copy of a Nutrition Toolkit from providers. Evidence-based nutrition recommendations have been compiled for cancer survivors from 4 sources into a Nutrition Toolkit. The sources include: (1) AmericanCancer Society (ACS) Nutrition and Physical Activity Guidelines for Cancer Survivors; (2)World Cancer Research Fund / American Institute for Cancer Research (WFRF/AICR) Cancer Nutrition Guide; (3) National Cancer Institute (NCI) Eating Hints; and (4) National Comprehensive Cancer Network (NCCN) Guidelines for Cancer Survivors. The Nutrition Toolkit outlines topics about the impact of cancer treatment on dietary intake patterns and quality, strategies to manage treatment-related eating issues, maintaining a healthy weight post treatment, and evidence-based recommendations and practical. Nutrition Toolkit strategies for improving diet quality and maintaining an optimal weight for cancer survivors.
15734787|NCT04986670|Behavioral|Monthly Emails|Monthly emails will be sent to participants to encourage the use of the toolkit with healthy recipes and general nutrition information.
15734788|NCT04986657|Device|ChromoSeq|Novel, streamlined whole genome sequencing approach
15734789|NCT04986644|Device|Hioxifilcon A standard hydrogel contact lens with Hyaluronic Acid (HA)|Daily disposable contact lens wear for 1 week
15734790|NCT04986631|Drug|Topiramate Tablets|Topiramate intervention
15734791|NCT04986618|Other|One-way Nordic Exercise|Participants in this group will be given the standard Nordic Hamstring exercise.
15734792|NCT04986618|Other|Two-way Nordic Exercise|In addition to the standard Nordic Hamstring exercise, participants in this group will do the same exercise backwards for the quadriceps.
15734793|NCT04986605|Other|Extracorporeal Photopheresis (ECP) with Methoxsalen|"Drug Intervention using a medical device. The phase II aspect of the study refers to the drug, methoxsalen. Methoxsalen is being used off label from the currently approved indications in the monograph. The study is proposing to use methoxsalen in combination with with extracorporeal photopheresis for the treatment of diffuse cutaneous systemic sclerosis. The ECP device is already licensed in Canada. License No.7703.
~ECP treatment, using the drug UVADEX, will be given on 2 consecutive days every 4 weeks for a total of 26 treatment days (48 weeks).
~Treatment will be given in addition to standard of care medications for SSc."
15734794|NCT04986579|Device|Paxman Scalp Cooling System|Cap attached to coolant lines connected to a refrigeration unit placed on scalp
15734795|NCT04986579|Drug|Eribulin|Intravenous Infusion
15734796|NCT04986579|Drug|Sacituzumab govitecan|Intravenous Infusion
15734797|NCT04986579|Drug|Trastuzumab deruxtecan|Intravenous Infusion
15734798|NCT04986566|Other|Best Practice|Use standard reporting procedures
15734799|NCT04986566|Behavioral|Health Education|Use Aetonixx app
15734800|NCT04986566|Other|Medical Device Usage and Evaluation|Wear Vivofit 4
15734801|NCT04986566|Other|Quality-of-Life Assessment|Complete questionnaires
15734802|NCT04986553|Device|Arthrex Clavicle Plates|Arthrex Clavicle Plate for treatment of clavicle fractures
15734803|NCT04986540|Drug|SHR-1906；Placebo|"Drug: SHR-1906 IV, single dose
~Drug: Placebo IV, single dose"
15734804|NCT04986527|Procedure|Chest tube suction|The chest tubes will be inserted using our institutional standard chest tube insertion tray. The chest tubes used will be our institutional standard and will range from 14 to 32Fr in size. After chest tube placement, an Atrium Oasis Dry Suction Water Seal Chest Drain (Getinge USA Sales, LLC) will be used.
15734805|NCT04986514|Other|Bio-banking without genetic analysis|For patients included in SCLERO-BIOBANK study, 2 blood samples will be collected at each SSc evaluation (usually once a year), in addition to the routine care blood collection.
15734806|NCT04986501|Device|MucoPEG|Experimental
15734807|NCT04986501|Device|Biotene|Active Comparator
15734808|NCT04986475|Other|Music Therapy|Music therapy was performed by listening to the ney sound during the non-stress test procedure.
15734809|NCT04986462|Procedure|shoulder arthroscopy|Patients underwent ubacromial bursectomy and acromioplasty , cuff debridement and cuff repair, side to side suture of rotator cuff combined with suture anchor.
15734945|NCT04985331|Device|W-GenZD|"W-GenZD is a program that delivers evidence based therapy for the symptoms of mild-moderate depression and anxiety in adolescents in brief conversations with a fully automated relational agent."
15734946|NCT04985318|Drug|Cablivi®|Intervention with Cablivi® take place outside of the study
15734810|NCT04986449|Behavioral|nutritional and culinary intervention|"Each family will attend a total of 4 culinary-nutritional workshops between April and June 2021. Workshops 1 and 2 will be held in the kitchen located at the Science Building of the University of Navarra and will be given individually to each family.
~Workshops 3 and 4 will be online (Zoom) and will be held in groups of 5 families. These workshops will be held from 5.30 pm to 7.30 pm on Fridays or from 11.30 am to 1.30 pm on Saturdays.
~Finally, a meeting will be organized with all the families (parents and children) where the recipes prepared by the children for the n-CHEF challenge will be shared and prizes will be awarded."
15734811|NCT04986436|Drug|HS-10360|Single or multiple dose(s) of HS-10360
15734812|NCT04986436|Drug|Placebo|Single or multiple dose(s) of Placebo
15734813|NCT04986423|Drug|ZEN003694|72 mg PO QD
15734814|NCT04986423|Drug|Enzalutamide|160 mg PO QD
15734815|NCT04986410|Diagnostic Test|CCTA, CT-MPI, CT-FFR, SPECT-MPI|Subjects undergo CCTA, CT-MPI, CT-FFR or SPECT-MPI
15734816|NCT04986397|Device|Cold Therapy|A Breg Polar Care Cube with WrapOn Polar Pad, Back will be filled with ice chips and water per manufacturer instructions and applied to the abdomen.
15734817|NCT04986397|Other|Standard of Care|Standard post-operative analgesia without the use of cryotherapy.
15734818|NCT04986384|Drug|Atoderm SOS spray Aerosol 200ml|A bottle of 200ml topical spray was used on the eczematous skin lesions for itch relief.
15734819|NCT04986371|Drug|Niraparib|Usage following drug insert is recommended
15734820|NCT04986358|Other|Follow up at 2 years|The patients will have a follow-up to carry out 2 years after their intervention in addition to their traditional care
15734821|NCT04986345|Other|High-intensity interval training (HIIT)-4|4 intervals of 4 minutes at 90% of maximum cardiac frequency, interspersed with 3-minute rests at 70% of maximum cardiac frequency. The session will last 32 minutes, including warm-up and cooldown.
15734822|NCT04986345|Other|High-intensity interval training (HIIT)-10|10 intervals of 1 minutes at 90% of maximum cardiac frequency, interspersed with 1-minute rests at 70% of maximum cardiac frequency. The session will last 34 minutes, including warm-up and cooldown.
15734823|NCT04986345|Other|Rest|Participants are to stay seated for 30 minutes while reading or watching television.
15734824|NCT04986332|Behavioral|Physical activity program|24-weeks moderate-intensity physical activity program
15734825|NCT04986332|Other|Global therapeutic remodeling|Re-assessing and therapeutic optimization of the whole burden of chronic pathologic conditions
15734826|NCT04986319|Diagnostic Test|Serum vitamin D assay|"Trained phlebotomists will collect 10 cc of a Blood sample. Specimen will be preserved at -40ºc for batch analysis.
~S Vitamin D, S iPTH, S Calcium, S Alkaline Phosphatase, S PO4, S Mg, S Albumin and S Creatinine will be done in BIRDEM laboratory. Vitamin D will be assayed by The ARCHITECT 25-OH Vitamin D assay system: Vitamin D will be assayed by The ARCHITECT 25-OH Vitamin D assay system: The ARCHITECT 25-OH Vitamin D assay is a chemiluminescent micro-particle immunoassay (CMIA). This technology is used for the quantitative analysis of 25(OH) D and aid in the assessment of vitamin D sufficiency."
15734827|NCT04986306|Procedure|SLNB + ALND|Patients who received neoadjuvant chemotherapy will undergo SLNB+ALND to evaluate the feasibility of SLNB
15734828|NCT04986293|Device|CPAP|Different settings of CPAP and BiPAP will be tested using a home mechanical ventilator
15734829|NCT04986280|Diagnostic Test|[18F]PSMA-1007|PSMA PET/CT using the intervention.
15734830|NCT04986267|Other|ACL Rupture|Female, aged 18-40 years of age with an acute ACL rupture of the knee that occurred within the last 3 months, who presented to a sports or orthopaedic clinic
15734831|NCT04986254|Other|Blood sampling|During a single dosing interval, each participant will have 1 - 8 blood samples taken for each antibiotic. Blood samples (3 mL each) will be drawn from an existing arterial line or central venous catheter. Blood samples will be collected on 2 separate occasions; Occasion 1, between Days 1 - 3 of antibiotic therapy and Occasion 2, between Days 3 - 6 of antibiotic therapy.
15734832|NCT04986254|Other|Epithelial lining fluid sampling|Epithelial lining fluid will be sampled using either a bronchoalveolar lavage (BAL) or mini-BAL technique, in accordance with the preferred procedure in participating sites. 3 BAL or mini-BAL samples will be collected over 2 separate occasions; Occasion 1, between Days 1 - 3 of antibiotic therapy and Occasion 2, between Days 3 - 6 of antibiotic therapy.
15734833|NCT04986254|Other|Urine sampling|The total urine volume over the duration of the dosing interval will be collected on the two sampling occasions for a calculated urinary creatinine clearance measurement.
15734834|NCT04986254|Drug|Study antibiotics include benzylpenicillin, ceftriaxone, meropenem, and piperacillin/tazobactam|Antibiotic dose and dosing interval will be determined by the treating clinician in accordance to standard prescribing practices based on clinical assessment of the patient. This study aims to recruit at least 20 participants per antibiotic.
15734835|NCT04986241|Drug|Statin|Chronic use of statin prescribed previously by the assistant physician.
15734836|NCT04986241|Other|Physical activity|Physically active participants
15734837|NCT04986241|Other|Sedentary|Physically inactive or sedentary participants.
15734838|NCT04986228|Other|Digital aftercare|The intervention group will receive a digital aftercare service, consisting of video calls and an app, for a period of up to eight weeks after discharge. These enable an uncomplicated and yet intensive exchange with the clinic from the comfort of the participants' own homes. To enable to optimally plan the treatment and assess its success, all participants complete questionnaires on multiple time points about different topics.
15734839|NCT04986228|Other|TAU|The control group will receive the regular follow-up consultations in the clinic (treatment-as-usual, TAU). This includes at least one consultation with the case-leading therapist from the previous inpatient stay about 6 weeks after discharge. The assessment consisting of questionnaires at multiple time points about different topics is the same as in the intervention group.
15734840|NCT04986202|Drug|AZD4831|AZD4831
15734841|NCT04986202|Other|Placebo|Placebo
15734842|NCT04986189|Diagnostic Test|Low dose CT thorax|A low dose CT scan of the thorax to screen for lung cancer
15734843|NCT04986176|Drug|HC-1119|oral
15734844|NCT04986176|Drug|Placebo|oral
15734845|NCT04986163|Device|Non-invasive analgesia monitoring with ANSPEC-PRO monitor and MEDSTORM monitor|The patients are monitored with two monitors under anesthesia: one monitor attached to the left hand and one monitor to the right hand. When one monitor is connected to the patient, the other monitor will be disconnected. The first monitor is ANSPEC and the second monitor used is MEDSTORM.
15734847|NCT04986163|Device|Non-invasive analgesia monitoring with MEDSTORM monitor and MEDASENSE monitor|The patients are monitored with two monitors under anesthesia: one monitor attached to the left hand and one monitor to the right hand. When one monitor is connected to the patient, the other monitor will be disconnected. The first monitor is MEDSTORM and the second monitor used is MEDASENSE.
15734849|NCT04986124|Other|treatment as usual|No inervention. Treatment regime remains unchanged.
15734850|NCT04986111|Procedure|Linear skin closure with wound drain|"An oval incision is made around the ileostomy and the continuity of the intestinal tract is restored after adhesion division.
~Methods of anastomosis include either side-to-side or end-to-end, hand-sewing or stapling.
~Linear suture of the rectus abdominis fascia layer by layer. A Jackson-Pratt drainage tube is placed in the subcutaneous tissue and vertical mattress suture is performed with a non-absorbable thread."
15734851|NCT04986111|Procedure|Purse-string skin closure with negative pressure wound therapy|"Recover the intestinal continuity after adhesion division by making a circular incision along the ileostomy Methods of anastomosis include either side-to-side or end-to-end, hand-sewing or stapling.
~Linear suture of the rectus abdominis fascia layer by layer. Negative pressure wound therapy is performed after suturing the subcutaneous tissue using absorbable thread."
15734852|NCT04986098|Device|TurboHawk|Directly remove the diseased plaque in the blood vessel to increase the effective lumen in the blood vessel
15734853|NCT04986098|Drug|Paclitaxel|Paclitaxel
15734854|NCT04986072|Drug|Sodium Nitroprusside|Half of participants will receive Intravenous Sodium Nitroprusside (0.5 μg/kg/min) for 4 hours.
15734855|NCT04986072|Drug|5% Dextrose solution|Half of participants will receive intravenous 5% Dextrose solution for 4 hours.
15734856|NCT04986059|Other|Pre-event massage|Five minutes massage, combining superficial and high-frequency techniques of massage applied with the therapist hands on gastrocnemius and hamstring muscles
15734857|NCT04986046|Other|Home Plate Lite|Home Plate Lite comprises electronic educational content (e.g. recipes, instructional videos) disbursed at least weekly.
15734858|NCT04986046|Other|Virtual Home Plate|Virtual Home Plate comprises two, 45-minute weekly sessions where parents work together with a study staff member to discuss the themes and prepare the components of a meal, including entrees, side dishes, and desserts.
15734859|NCT04986046|Other|Fruit and Vegetable prescription|All families will receive FVRx over two months; FVRx can be redeemed for fresh, frozen, or canned produce at participating retailers in Philadelphia
15734860|NCT04986020|Diagnostic Test|MRI|Identification of novel biomarkers from MRI
15734861|NCT04986007|Behavioral|Digital Cognitive Behavioral Therapy for Insomnia|Digital cognitive behavioral therapy for insomnia is an automated, internet-based delivery system for the core components of cognitive behavioral therapy for insomnia (CBT-I). For this trial, dCBT-I will be delivered using Sleep Healthy Using the Internet (SHUTi), which delivers the core content of CBT-I in 6 interactive lessons called Cores: Getting Ready; Sleep Scheduling; Sleep Practices; Thinking Differently; Sleep Hygiene; and Moving On. The primary therapeutic approaches deployed through these cores are stimulus control and sleep restriction. The minimum acceptable dose for this study is completion of 4 out of 6 cores; completion of fewer than 4 cores will be considered a dropout.
15734862|NCT04985968|Drug|Cobitolimod 250 mg|Rectal administration
15734863|NCT04985968|Drug|Cobitolimod 500 mg|Rectal administration
15734864|NCT04985968|Drug|Placebo|Rectal administration
15734866|NCT04985942|Drug|Lumateperone|Lumateperone 42 mg capsules administered orally, once daily.
15734867|NCT04985942|Drug|Placebo|Matching capsules administered orally, once daily.
15734868|NCT04985929|Drug|Sildenafil 50 mg|Sildenafil is a phosphodiesterase type-5 inhibitor, which augments/prolongs the naturally occurring nitric oxide mediated vasodilatory pathway. Sildenafil pill is over-encapsulated to be identical in appearance to the placebo intervention.
15734869|NCT04985929|Drug|Placebo|Medical-grade placebo pill, over-encapsulated to be identical in appearance to the sildenafil intervention.
15734870|NCT04985916|Biological|Vehicle|topical liniment without investigational product
15734871|NCT04985916|Biological|botulinum toxin, Type A|ET-01 topical liniment
15734872|NCT04985903|Behavioral|Clinician Communication Intervention|The focus of the communication program is to help clinicians increase their use of the 5 A's by improving knowledge, self-efficacy, outcome expectations, and communication skills. Training modules include didactic information with video clips of sample conversations showing specific communication skills, feedback on clinician's usage of the 5A's, and audio clips from their Pre-Intervention recorded conversations.
15734873|NCT04985903|Other|5A's lecture|a lecture on general information about smoking cessation for pregnant patients and smoking cessation counseling.
15734874|NCT04985890|Biological|UB-421|UB-421 will be used 10mg/kg weekly intravenous infusion for 8 weeks. Antiretroviral therapy will be interrupted during entire study.
15734875|NCT04985890|Other|UB-421+chidamide|10 mg/kg UB-421 weekly intravenous infusion combined with oral 10 mg chidamide twice a week for 8 weeks. The dates of taking chidamide will be on the one day and three days after the first administration of UB-421.Antiretroviral therapy will be interrupted during entire study.
15734876|NCT04985877|Dietary Supplement|Yakult light 300|2 bottles of fermented Milk containing Lactobacillus casei Strain Shirota per day, Intervention for 12 weeks.
15734877|NCT04985864|Device|Brain stimulation|tDCS brain stimulation on leg motor areas was applied to stroke patients.
15734878|NCT04985864|Device|Treadmill gait training|Lokomat robot training was applied to stroke patients.
15734947|NCT04985305|Behavioral|Teaching material|The GPs receive a power-point slide show to use at the nursing home. The slide show includes a description of BPSD symptoms, what the mechanism, effect and adverse events of antidepressants and a rationale for deprescribing.
15751921|NCT04844021|Behavioral|Nudge|"EHR-based nudge"
15734881|NCT04985838|Behavioral|HEADS: UP (Helping Ease Anxiety and Depression)|A group-based Mindfulness Based Stress Reduction (MBSR) course adapted for people affected by stroke and delivered online using a video communication platform. An introductory session in the first week is followed by 8 weekly sessions (2.5 hours, incorporating 30-minute comfort breaks). A 6-hour silent retreat is offered in week 7. An optional follow-up session is offered six-eight weeks after completion of the 9-week course. Course materials include a manual (provided after the introductory session), weekly pre/post-session emails with instructions and information about joining the sessions and engaging in personal practice, including links to audio files to complement class-based sessions.
15734882|NCT04985825|Drug|Imgatuzumab|Imgatuzumab administered as an intravenous infusion on Day 1 and Day 8 of the first 21-day cycle, and on Day 1 of each subsequent 14-day cycle.
15734885|NCT04985799|Device|Gynecare TVT Exact Continence System|Participants will have placement of Gynecare TVT Exact sling.
15734886|NCT04985799|Device|Neomedic KIM (Knotless Incontinence Mesh)|Participants will have placement of retropubic Neomedic KIM (Knotless Incontinence Mesh) sling
15734887|NCT04985786|Behavioral|Cognitive Behavioral Therapy for reducing risk behaviors|Cognitive Behavioral Therapy to reduce risk behaviors and increase risk perception that combines a standardised face-to-face group therapy before discharge from in-patient treatment and a standardised ecological momentary intervention delivered by mobile phones during the four weeks after discharge. For SZ the target risk behavior is medication non-adherence and for AUD and AUD & SZ it is alcohol use.
15734888|NCT04985786|Behavioral|Cognitive Behavioral Therapy for increasing non-risk behaviors|Cognitive Behavioral Therapy to increase non-risk behaviors that combines a standardised face-to-face group therapy before discharge from in-patient treatment and a standardised ecological momentary intervention delivered by mobile phones during the four weeks after discharge. In this control intervention for patient groups the target behavior is cognitive exercises.
15734890|NCT04985760|Biological|Trimer 4571 vaccine 100mcg with 500mcg alum adjuvant|Investigational vaccine composed of Trimer 4571 100mcg, alum (aluminum hydroxide suspension) adjuvant 500mcg, and phosphate buffered saline diluent
15734891|NCT04985760|Biological|Placebo control for Trimer 4571 vaccine 100mcg with 500mcg alum adjuvant|Volume matched control for Trimer 4571 vaccine 100mcg
15734892|NCT04985760|Biological|Trimer 4571 vaccine 500mcg with 500mcg alum adjuvant|Investigational vaccine composed of Trimer 4571 500mcg, alum (aluminum hydroxide suspension) adjuvant 500mcg, and phosphate buffered saline diluent
15734893|NCT04985760|Biological|Placebo control for Trimer 4571 vaccine 500mcg with 500mcg alum adjuvant|Volume matched control for Trimer 4571 vaccine 500mcg
15734894|NCT04985747|Other|Polished palatal surface|Polishing of the anterior palatal surface using a polisher
15734895|NCT04985747|Other|Roughened palatal surface|Roughening of the anterior palatal surface using a sandblaster
15734896|NCT04985747|Other|Opened palatal surface|Opening of the anterior palatal surface using acrylic bur
15734897|NCT04985734|Diagnostic Test|Specific diagnostic work-up for ATTR-CM patients|Technetium-scintigraphy
15734898|NCT04985721|Drug|Pamiparib|40 mg orally twice a day
15734899|NCT04985721|Drug|Tislelizumab|200 mg IV every 21 days
15734900|NCT04985708|Other|data collection of clinically available procedures|when to place Impella related to PCI in patients with AMICS
15734904|NCT04985682|Biological|ADVATE|Antihemophilic factor (AHF) activity expressed in international units (IU) per vial.
15734905|NCT04985669|Drug|Prucalopride 2mg|one group of patient will receive prucalopride once daily one group of patient will receive lubiprostone twice daily
15734906|NCT04985656|Drug|Pevonedistat|Pevonedistat IV infusion
15734907|NCT04985656|Drug|Decitabine|Decitabine tablets
15734908|NCT04985656|Drug|Cedazuridine|Cedazuridine tablets
15734909|NCT04985630|Dietary Supplement|Mitopure|Fruit flavored sachet containing fixed dose of Mitopure™ (Proprietary Urolithin A)
15734910|NCT04985630|Dietary Supplement|Pomegranate Juice|100% Pomegranate juice
15734911|NCT04985617|Other|Warmed Fluids|The IV fluid given to the patients in the intervention group was heated to 36ºC using the medical heating device.
15734913|NCT04985591|Procedure|Liposuction|A small, inconspicuous incision was made in the liposuction group to dislodge fat out of the body.
15734914|NCT04985591|Procedure|Other plastic surgery|Other plastic surgery like blepharoplasty or keloid excision.
15734915|NCT04985578|Other|Dry needling|The therapist will located the TrP that refers the most pain and will apply manual compression until the participant will reported pain. After that, dry needling technique will be performed on the TrP for 60 seconds.
15734916|NCT04985578|Other|Sham dry needling|The therapist will located the TrP that refers the most pain and will apply manual compression until the participant will reported pain. After that, dry needling technique will be performed on the TrP for 60 seconds with a sham needle without tip.
15734917|NCT04985565|Other|Dietary Intervention|Participate in Mediterranean diet
15734918|NCT04985565|Procedure|Radical Prostatectomy|Undergo standard of care radical prostatectomy
15735051|NCT04984525|Drug|SYNB1618|SYNB1618 is formulated as a nonsterile solution intended for oral administration
15751922|NCT04844021|Behavioral|Nudge+|"EHR-based nudge plus facilitation"
15734919|NCT04985552|Procedure|DIEP Breast Reconstruction|All patients enrolled in the study will undergo DIEP breast reconstruction and have their abdominal incision sutured according to routine clinical practice: 3-0 VICRYL ® suture (Ethicon, USA) for deep fascia closure, 4-0 MONOCRYL® suture (Ethicon, USA) for deep dermal closure, and 5-0 MONOCRYL® suture (Ethicon, USA) for subcuticular closure.
15734920|NCT04985552|Device|ciNPT|Following closure of the abdominal donor site, the closed incision will be dressed with the ciNPT system [V.A.C.ULTA™ Negative Pressure Wound Therapy System (KCI, USA)] applied by the operating surgeon in a sterile fashion. The ciNPT device will be set at -125mmHg of continuous negative pressure for a period of 7 days or until patient discharge from hospital. Removal of the ciNPT dressing will be performed by the surgical team at the time of discharge. Following removal, no additional dressings will be applied to the abdominal incision unless clinically indicated secondary to dehiscence.
15734921|NCT04985552|Other|Conventional Tape Dressings|Following closure of the abdominal donor site, the closed abdominal incision will be dressed with 1-inch Micropore™ Surgical Tape (3M, USA) with an alcohol swab applied to the tape for additional adhesion, by the operating surgeon in a sterile fashion. This dressing will remain in-situ for up to 7 days or until patient discharge from hospital. Removal of the traditional tape dressing will be performed by the surgical team at the time of discharge. Following removal, no additional dressings will be applied unless clinically indicated secondary to dehiscence.
15734922|NCT04985539|Device|Verily Study Watch|Participants wear the Verily Study Watch for 2 years, for longitudinal data collection.
15734923|NCT04985526|Other|Octeniderm (octenidine dihydrochloride, 1-propanol, 2- propanol)|Administering Octeniderm (octenidine dihydrochloride, 1-propanol, 2- propanol) or 0,9% sodium chloride (as control agent) to the skin
15734924|NCT04985513|Procedure|Ventilation during cardiopulmonary bypass|Ventilation was performed using an inhaled oxygen fraction of 20% and a tidal volume of 5ml/kg at the time of cardiopulmonary bypass.
15734925|NCT04985500|Procedure|ESP block|peripheral nerve block
15734926|NCT04985500|Procedure|PIF block|peripheral nerve block
15734927|NCT04985500|Procedure|Ultrasound|Ultrasound guidance
15734928|NCT04985500|Drug|Bupivacain|10-20 mL of 0.25% bupivacaine
15734929|NCT04985487|Other|brolucizumab|Prospective observational study. There is no treatment allocation. Patients administered brolucizumab, that have started before inclusion of the patient into the study will be enrolled.
15734930|NCT04985474|Other|questionnaires|
15734931|NCT04985461|Device|dental occlusion ties maxillo-mandibular fixation|"This research study is being done to determine if dental occlusion ties can adequately align and stabilize jaw fractures. The chief goal of jaw fracture repair is to ensure that the teeth align normally. Traditionally, alignment has been accomplished by using steel wires and bars (having the jaw wired). Dental occlusion ties are newer devices similar to cable ties or zip ties that are wrapped around and/or between some of the teeth and secured. This procedure is intended to hold the teeth in similar alignment as wires, yet with less application time and less damage to the gums."
15734932|NCT04985435|Drug|Filgotinib|200 mg tablet once daily or 100 mg once daily
15734933|NCT04985435|Drug|Anti-Tumor Necrosis Factor Alpha Drug (Product)|Adalimumab subcutaneous injections 40 mg once every two weeks Etanercept subcutaneous injections 50 mg weekly
15734934|NCT04985435|Behavioral|50 patients will have a Free Choice between Filgotinib and anti TNF|50 patients will be given the opportunity to choose between either TNFi (etanercept 50 mg SC once a week or adalimumab 40 mg SC once every two weeks) or filgotinib, an oral JAKi, 200 mg once a day while another group of 50 patients will be randomized to the same treatment arms.
15734935|NCT04985422|Behavioral|Smartphone-based Daily Ecological Momentary Intervention|Interventions are delivered through smartphones (SMS text message + Qualtrics) at a low cost with high accessibility. Participants are prompted 6 random times a day over the set intervention period (4 weeks) to complete brief EMA and EMI intervention actions) across contexts in daily lives for the reduction of depressive symptoms, as well as rumination distress, and improve functioning.
15734936|NCT04985422|Behavioral|Smartphone-based Weekly-delivered Information|Information with simple actions for reducing depressive symptoms are delivered through smartphones (SMS text message + Qualtrics) at a low cost with high accessibility. Participants are prompted weekly with a new set of information, together with a 5-min assessment. The information includes intervention actions provided in the EMI group.
15734937|NCT04985409|Behavioral|Feedback|The system uses Sonifi health (TV content and visualizations) and Fitabase (3rd party server to process Fitbit data and export to Sonifi). The system utilizes the patient's TVs to engage the patient and multidisciplinary team in monitoring ambulation status.
15734938|NCT04985396|Drug|Platelet Rich Plasma (PRP) group|Platelet Rich Plasma (PRP) group will be intervened with PRP injection. The collection of 30 ml blood of patients into acid citrate dextrose tube under aseptic condition will be done and subjected for centrifugation at 2000 rpm (soft spin) through digital centrifuge machine speed control (REMI, R-8C PLUS). There will be three layers of blood, among them the supernatant layer and buff coat of plasma will be again subjected to centrifuge at 3000 rpm (hard spin). The upper two thirds of the tube containing platelet poor plasma will be discarded and finally, the lower one third concentrated platelet plasma superficial buffy coat will be injected into medial calcaneal tuberosity at the most tender point.
15734939|NCT04985383|Device|AKST1210|Procedure: Hemodialysis
15734940|NCT04985370|Other|Pain neuroscience education|Three sessions of pain neuroscience education based on explaining patients: characteristics of acute versus chronic pain, function of acute pain, how acute pain is originated within the nervous system, how acute pain progress to chronic pain, and factors that contribute to central sensitization (e.g., emotions, stress, disease and pain beliefs, behaviors regarding pain...). All the explanations will be conducted using easy-understandable examples and metaphors.
15734941|NCT04985370|Other|Exercise|Progressive resistance exercise program based on isometric, concentric, eccentric, and pliometric contractions.
15734942|NCT04985344|Drug|Propranolol Oral Product|Child will receive oral propranolol (syrup). The dose of propranolol will increase gradually over the first 3 treatment sessions in order to assess tolerance.
15734943|NCT04985344|Drug|Placebo|Child will receive oral placebo (syrup). The dose of placebo will increase gradually over the first 3 treatment sessions in order to match propranolol intervention.
15734944|NCT04985344|Other|memory reactivation|90 minutes after the propranolol take, a trained psychologist will ask the child to recount his trauma.
15734948|NCT04985305|Behavioral|Pre-visit reflection tool|The GPs receive a checklist and an email template to ensure; 1) The home visit is planned on a day where the staff at the nursing home that knows the patient best is at work. 2) The staff at the nursing home contacts the relevant relatives and informs about the home visit. 3) The symptom assessment scale is complete by the nursing home staff and returned to the GP prior to the home visit
15734949|NCT04985305|Behavioral|Dialogue tool|The dialogue tool includes a list of questions to help the GP explore the nursing home staffs', patients' and relatives' concerns and views on deprescribing antidepressants, as well as information on when to contact the GP. The intervention has been developed during a tailoring process involving GPs, nursing home staff, interviews with patients and other experts in the field.
15734950|NCT04985305|Behavioral|Educational session for GPs|Before randomization all participating GPs receive a ½-day course on the evaluation and treatment of neuropsychiatric symptoms that occur in patients with dementia. Elaborate information about antidepressants to this population and reasons to discontinue use. A sSpecialists in general practice, pharmacology and geriatrics/gerontopsychiatrics teaches the course. The course is mandatory for the participating GPs, but voluntary for the staff at the GPs office. The course is preferably held with actual attendance, but may be converted to an online meeting due to the COVID-19 pandemic.
15734951|NCT04985305|Behavioral|Symptom assessment scale|An email template containing 12 screening questions from the Neuropsychiatric Inventory Nursing Home Edition is given to the GPs to distribute to the nursing home prior to the home visit and 1 month after the home visit
15734952|NCT04985292|Dietary Supplement|Probiotic, Lactobacillus|10^10 colony-forming units of a Lactobacillus strain, packaged in a capsule, once daily
15734953|NCT04985292|Dietary Supplement|Placebo|Inactive substance packaged to be identical to active treatment
15734954|NCT04985279|Device|Position and Angle Marking System|Position and Angular Marking System (PAMS) attaches on to the ultrasound probe. When the desired insertion site is identified by ultrasound, the doctor gently presses PAMS into the patient's back to create skin indentations demarcating the needle insertion point. These indentations are not affected by skin sterilisation, and may improve accuracy and reduce the time taken to perform the epidural procedure. Next, the angle between the ultrasound probe and the patient's back can be measured using PAMS, and this angle can be maintained using a needle guide during the epidural procedure.
15734955|NCT04985279|Device|Standard clinical practice|When the desired insertion site is identified by ultrasound, the doctor demarcate the needle insertion point using marker pens.
15734956|NCT04985266|Drug|Palbociclib 125Mg Tab|Palbociclib Tablets, 125 mg orally once daily, beginning on Cycle 1, on Days 1-21 of each 28-day cycle.
15734957|NCT04985266|Drug|Fulvestrant injection|Fulvestrant Intramuscular injections, 500 mg as two injection of 250mg fulvestrant in 5ml solution at each visit. No fulvestrant dose reductions are permitted. Administered on days 1, 15 (plus or minus 3 days), 29 (plus or minus 3 days), and every 28 (plus or minus 3 days) days thereafter.
15734958|NCT04985266|Drug|Tamoxifen|As per clinical guidelines
15734959|NCT04985266|Drug|Letrozole|As per clinical guidelines
15734960|NCT04985266|Drug|Exemestane|As per clinical guidelines
15734961|NCT04985266|Drug|Anastrozole|As per clinical guidelines
15734962|NCT04985253|Other|prediction of overall survival using Web based PREDICTV2.0 portal|"Predict is an online prognostication and treatment benefit tool developed in the UK, using cancer registration and survival data recorded by the Eastern Cancer Registration and Information Centre (ECRIC) for 5694 women diagnosed in East Anglia from 1999-2003.
~The model was validated in a second cohort of 5468 women from the West Midlands Cancer Intelligence Unit and is available online (www.predict.nhs.uk) providing 5-and 10-year survival estimates and treatment benefit predictions. Wong et al, tested the predictive accuracy of PREDICT V1.0 in the southeast Asian population. There were 67% Chinese patients while 13% were Indians. They showed concordance in observed and predicted OS in most subgroups except for women whore less than 40 years of age."
15734963|NCT04985240|Dietary Supplement|Lettuce with no biofortification|Lettuce without any biofortification was assigned to each participant belonging to the control group which ate 100gr every day for 10 days
15734964|NCT04985240|Dietary Supplement|Intervention Molibdenum group|Lettuce with Iodine biofortification was assigned to each participant belonging to the intervention group which ate 100gr every day for 10 days
15734965|NCT04985227|Other|Home weight monitoring|Parents will be provided with weighing scales to weigh their infant at home and plug in the weight in the patient portal for review by their primary care provider.
15734966|NCT04985214|Other|Questionnaire|Questionnaire on the quality of life
15734967|NCT04985201|Drug|Irinotecan|Irinotecan intravenous infusion was administered at a dose of 60 mg/m^2 on Day 1,8 of each 21-day cycle.
15734968|NCT04985201|Drug|Simvastatin|Simvastatin 40 mg daily oral tablet taken.
15734969|NCT04985188|Diagnostic Test|Quantitative ultrasound (QUS) technique|Measurement of quantitative ultrasound parameter using clinical US machine (RS85)
15734970|NCT04985175|Behavioral|Question prompt list|The specific QPS was a one page leaflet for chronic kidney disease which developed by applied literature and public QPL from the National Health Agency. It contains 3 domains 25 questions related to treatment, dialysis, and Kidney transplant. The QPL group participants were asked to read and mark those questions they concerned or write down additional problems.
15734971|NCT04985162|Other|Intervention group|Differential learning based physiotherapy to improve torso control, balance and gait
15734972|NCT04985162|Other|Control group|Ordinary physiotherapy program
15734973|NCT04985149|Other|Electromyographic measurement:|"Nerve conduction studies; assesses nerve function and includes motor, sensory, and mixed nerve tests.
~Micromed (Italy 2020) EMG device will be used in the electrophysiological examination. Sensory and motor conduction studies will be performed in the lower and upper extremities by paying attention to the extremity temperatures of the cases.
~Nerve conduction studies will be performed by another physician who is unaware of the diagnosis of the patients. Bilateral lower extremity sural sensory responses of the patients will be taken.
~In the antidromic method in sural nerve conduction examination, the bipolar superficial electrode is placed behind the lateral malleolus; stimulation will be made with bipolar surface electrodes 12-15 cm proximal to the recording site. Initial latency should be < 3.8 ms, amplitude > 10 Mv, and conduction velocity > 36 m/sec in sensory response of the sural nerve."
15735052|NCT04984512|Drug|Mitizodone Phosphate tablets|Mitizodone Phosphate tablets will be administered with food.
15734974|NCT04985149|Other|Ultrasonographic measurement:|Sural nerve ultrasonography (US) will be performed by another clinician (Merve Akdeniz leblebicier) who is experienced in musculoskeletal ultrasonography and unaware of clinical evaluation, using a 6-18 Mhz linear probe. (Mindray -UMT 200, United States) Both sural nerve joints of the patients will be evaluated. The patient will lie on the stretcher in the prone position, the ankle will be out of the bed. The 14 cm above the malleolus will be marked as the main line, the nerve will be detected in the lateral of the tendon of the gastrocnemius muscle and the proximal of the saphenous vein. Nerve diameter measurement will be measured 3 times in mm2 and the average will be taken. Then, possible inflammatory pathologies will be ruled out by providing clinical confirmation using the Doppler mode (11).
15734979|NCT04985123|Device|Pre-Formed Penile Silicone Block Implant|Implantation of Pre-Formed Penile Silicone Block Implant
15734980|NCT04985110|Drug|Cotrimoxazole|The treatment group will receive Cotrimoxazole Forte 960 mg PO q.d. 4 hours before the biopsy procedure.
15734981|NCT04985110|Drug|Placebo|The placebo group will receive placebo q.d. 4 hours before the biopsy procedure.
15734982|NCT04985097|Procedure|Implantation of trifocal diffractive intraocular lenses|Postsurgical monocular and binocular assessment of corrected and uncorrected near, intermediate and distance visual acuity and near and distance mesopic contrast sensitivity before and after the assigned vision training
15734983|NCT04985084|Behavioral|The intervention group|The intervention will last for 6 weeks and target 6 dietary behaviors that are relevant to gastric cancer. The intervention components include 3 sessions of online group education with 10-12 participants in each group and 3 sessions of individual telephone counselling.
15734984|NCT04985084|Other|Usual care|General dietary advice provided as routine by the nurses in the hospital.
15734985|NCT04985071|Procedure|Pancreaticoduodenectomy|Patient with periampullary cancer will be underwent pancreaticoduodenectomy in 2 types of pancreatic-jejunal anastomosis reconstructions. We describe the postoperative complications (pancreatic fistula and bleeding) and analysis the risk factors relate to those complications
15734986|NCT04985058|Drug|abemaciclib|treatment with abemaciclib
15734987|NCT04985045|Other|Evaluation|Individuals' menstrual status, pain, menstrual symptoms and genital hygiene behaviors will be evaluated.
15734988|NCT04985032|Radiation|stereotactic body radiation therapy|Treatment technique used to deliver a highly focused and accurate radiation dose to a defined target volume outside the brain; the entire course of therapy delivered in five fractions or less
15734989|NCT04985019|Procedure|Arm I (Prepectoral)|Participants followed the Self-Guided Virtual Reality-based Cognitive Behavioral Therapy for 4 weeks.
15734990|NCT04985019|Other|Arm II (Subpectoral)|Participants followed the Self-Guided Virtual Reality-based Cognitive Behavioral Therapy for 4 weeks.
15734991|NCT04985006|Behavioral|running at moderate intensity|intensity was determined by calculating the subject's heart rate reserve using the formula: ((resting heart rate maximal - resting heart rate) x % of target intensity) + resting heart rate. At moderate intensity, the subject will be asked to run at 50-59% Heart rate reserve (HRR) for 30 minutes from the time the target intensity is reached.
15734992|NCT04985006|Behavioral|running at high intensity|intensity was determined by calculating the subject's heart rate reserve using the formula: ((resting heart rate maximal - resting heart rate) x % of target intensity) + resting heart rate. At moderate intensity, the subject will be asked to run at 70-75% HRR for 30 minutes from the time the target intensity is reached.
15734993|NCT04984993|Device|MED3000|Gel formulation
15734994|NCT04984993|Drug|Tadalafil 5mg|Tablets
15734995|NCT04984980|Drug|Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab|Combination of Gemcitabine, Oxaliplatin, Sintilimab and Bevacizumab
15734996|NCT04984967|Device|Insertion of peripheral venous catheter with micro-guide|After antisepsis, the vein is punctured using a needle. Then the micro-guide is inserted to the first landmark, which indicates the passage of the micro-guide beyond the end of the needle. After the needle removed, the peripheral venous catheter is placed on the micro-guide. The guide is then removed, the peripheral venous catheter can be used.
15734997|NCT04984967|Other|Classic insertion of peripheral venous catheter, without micro-guide|After antisepsis, the catheter is introduced into the vein by a needle which is subsequently removed while the catheter remains in place.
15734998|NCT04984954|Drug|MUSK pill|This is a multicenter, randomized, double-blind, placebo-controlled clinical trial. Patients were treated with the trial drug or placebo in a 1:1 ratio. The experimental group was treated with MUSK pill (4 pills / day, 3 times / day) on the basis of conventional treatment until the end of follow-up
15734999|NCT04984902|Device|Extracorporal therapy|Extracorporal therapy
15735000|NCT04984889|Drug|TAK-662|Lyophilized, sterile concentrate of human protein C
15735001|NCT04984876|Drug|ligelizumab|Subcutaneous injection once every 4 weeks
15735002|NCT04984876|Drug|Placebo|Subcutaneous injection once every 4 weeks
15735003|NCT04984863|Device|Magnetically controlled capsule endoscopy|Magnetically controlled capsule endoscopy (MCE) is a non-invasive detection method independently developed in China that covers the whole digestive tract (except colon) mucosa.
15735004|NCT04984850|Other|Oral chemotherapy information and support|Multimodal intervention : (1) handouts and videos presenting information and supportive resources for common oral chemotherapy related issues, (2) phone call(s) from a nurse in oncology, and (3) e-reminders to take medication. The intervention will be available to experimental group participants on mobile platform.
15735005|NCT04984837|Drug|Lacutamab|750 mg/IV
15735006|NCT04984837|Drug|Gemcitabine|1000 mg/m²
15735007|NCT04984837|Drug|Oxaliplatine|100 mg/m²
15735008|NCT04984824|Behavioral|Nap duration|A cognitive battery which will be repeated at 1505, 1530, 1600 and 1900. Material for the picture encoding task will be learned at 1630 and will be tested at 2000.
15735053|NCT04984512|Drug|Placebo-matching tablets|Placebo will be administered with food.
15752700|NCT04837118|Other|Quality-of-Life Assessment|Ancillary studies
15735011|NCT04984798|Drug|Vitamin E|Twice daily oral supplementation with Vitamin E for 6-9 weeks.
15735012|NCT04984759|Drug|Primaquine|Primaquine GPO® (Government Pharmaceutical Organization (GPO), Thailand) 0.5 mg/kg will be given once daily with food for 14 days. This is the dose recommended for radical cure of P. vivax in tropical areas with high rates of relapse, such as the study design setting. Doses will be directly supervised (DOT).
15735013|NCT04984759|Drug|Tafenoquine|Tafenoquine (Kodatef, Biocelect Pty Ltd.) 300 mg will be given as a directly observed single dose with food. This is the standard dose recommended globally for radical cure of P. vivax.
15735014|NCT04984746|Dietary Supplement|No Intervention: (control group)|Lettuce without any biofortification was assigned to each participant belonging to the control group which ate 100gr every day for 10 days
15735015|NCT04984746|Dietary Supplement|Experimental: intervention group|"Molybdenum Iodine group
~Lettuces with Iodine and Molybdenum biofortification was assigned to each participant belonging to the intervention group which ate 100gr of each type of lattuce every day for 10 days"
15735016|NCT04984733|Drug|Temozolomide|"Metronomic TMZ 50mg/m2/day orally for 3 months then nivolumab 240mg IV +/- TMZ until progression.
~Patients who don't progress on TMZ will commence with combination treatment; TMZ + Nivolumab at 3 mths. Patients who progress on TMZ will start monotherapy with nivolumab. Patients will remain on monotherapy with nivolumab or combination therapy until progression or up to a maximum of 24mths."
15735017|NCT04984733|Drug|Temozolomide 50mg/m2/day|Metronomic TMZ 50mg/m2/day orally until progression then nivolumab 240mg IV until progression
15735018|NCT04984733|Drug|Temozolomide 3 month|Metronomic TMZ 50mg/m2/day orally for 3 months, then nivolumab 240mg IV and TMZ until progression.
15735019|NCT04984733|Drug|Temozolomide 24month|Metronomic TMZ 50mg/m2/day orally for 3 months, then nivolumab 240mg IV and TMZ until a maximum of 24 months
15735020|NCT04984720|Behavioral|Smartphone based digital application|Smartphone Based Digital Application to Track Migraine, Offer Pill Reminders for Medication Adherence and Community Blog
15735021|NCT04984707|Drug|KX0826|AR antagonist
15735022|NCT04984707|Other|Placebo|Placebo of KX-826
15735023|NCT04984694|Behavioral|Computerized virtual reality training programs group (Hot-Plus group)|"In this study, the investigators utilised interactive-video games called Xavix Hot Plus(Hot-plus, Shinsedai[SSD] Co. Ltd, Shiga Japan), which was designed specifically for rehabilitation and reported high participant motivation and enjoyment while playing."
15735024|NCT04984694|Behavioral|Social interaction group|The social interaction group will get together as a group for social interaction one hour weekly for 12 weeks.
15735025|NCT04984681|Behavioral|Mindfulness|The traditional mindfulness intervention consists of the following: (1) orientation; (2) a series of eight weekly session of 2.5 to 3 hours; (3) a silent retreat during the between weeks 4 and 6; (4) daily home assignments including formal and informal mindfulness practices; and (5) didactic presentations on stress and the consequences of stress.
15735026|NCT04984681|Other|Usual Care|The control condition will continue receiving usual care or standard of care.
15735027|NCT04984668|Drug|GT90001+KN046|GT90001 7.0mg/Kg， KN046 5mg/Kg
15735028|NCT04984668|Drug|GT90001+KN046|GT90001 7.0mg/Kg ， KN046 3mg/Kg
15735029|NCT04984668|Drug|GT90001/KN046|GT90001 4.5mg/Kg / KN046 5mg/Kg
15735030|NCT04984668|Drug|GT90001+KN046|GT90001 4.5mg/Kg， KN046 3mg/Kg
15735031|NCT04984668|Drug|GT90001+KN046|GT90001 3mg/Kg ， KN046 3mg/Kg
15735032|NCT04984655|Device|30-minute Virtual Reality (VR) Experience delivered through Oculus Quest 2 VR headset|All participants will go through the same intervention described above
15735033|NCT04984642|Other|diet|have OGTT,normal diet, high fat diet, low calorie diet, and ketogenic diet in turn
15735034|NCT04984629|Device|HYDRAFIL|The ReGelTec HYDRAFIL System is comprised of delivery system, 17G delivery needle and a syringe prefilled with HYDRAFIL Implant - Figure 1. Each delivery system is a Single Use Device that will be used for a single implant, then disposed of after injection. A new delivery system is required for each implant, as deemed necessary based on the screening MRI to target the degenerative discs in the lumbar spine.
15735038|NCT04984603|Procedure|PLR in patients under VA-ECMO|After securing the VA-ECMO tubing, PLR is realized using an automatic bed elevation technique. The lower limbs are raised to a 45° angle while the patient's trunk is lowered in supine position
15735039|NCT04984577|Drug|Compound Edaravone Injection-Low dose|Compound Edaravone Injection 30mg/dose (Edaravone 30mg, Taurine 600 mg), one dose every 12 hours, continue for 14 days
15735040|NCT04984577|Drug|Compound Edaravone Injection-High dose|Compound Edaravone Injection 50mg/dose (Edaravone 50mg, Taurine 1000 mg), one dose every 12 hours, continue for 14 days
15735041|NCT04984577|Drug|Edaravone Injection|Edaravone Injection 30mg/dose, one dose every 12 hours, continue for 14 days
15735042|NCT04984577|Drug|Placebo injection|Placebo injection, one dose every 12 hours, continue for 14 days
15735043|NCT04984564|Other|None. As this was an observational study.|Observational study.
15735044|NCT04984551|Other|Extension of Community Health (ECHO) Telementoring Clinic|Participate in ECHO clinics presenting cases for guidance and feedback
15735045|NCT04984551|Other|In-Country Workshops|In-Country Workshops Participate in hands-on training and workshops
15735046|NCT04984551|Other|Professional Oncology Educations Programs|Receive 5 core online lectures
15735047|NCT04984551|Other|Medical Chart Review|Medical charts are reviewed for data collection
15735048|NCT04984551|Other|Questionnaire Administration|Complete questionnaire(s)
15735049|NCT04984538|Other|Pharmacogenomic Testing|Cheek swab as a part of routine care
15735050|NCT04984525|Drug|SYNB1934|SYNB1934 is formulated as a nonsterile solution intended for oral administration
15735054|NCT04984499|Device|Dental implant|"The procedure used to accomplish its intended use is as follows :
~The recipient implant site is prepared using a drilling sequence, then the implant is placed at the crestal level After a period of osseointegration of the implant, a transgingival healing screw is placed to allow the healing of soft tissues. After this healing phase, the final prosthesis will be loaded on the implant."
15735055|NCT04984486|Device|dental implant|"The procedure used to accomplish its intended use is as follows :
~The recipient implant site is prepared using a drilling sequence, then the implant is placed at the crestal level
~After a period of osseointegration of the implant, a transgingival healing screw is placed to allow the healing of soft tissues. After this healing phase, the final prosthesis will be loaded on the implant."
15735056|NCT04984473|Device|Inspiratory muscle training|Inspiratory muscle training for 12 weeks at 40% maximal inspiratory pressure
15735057|NCT04984460|Diagnostic Test|Fluorescence morphological detection of liquid-based thin-layer film-making fungi|"Samples from outpatient or inpatient clinics to be tested for fungal vaginitis. A sample of one or more of the following characteristics. Symptoms: vulva pruritus, burning pain, but also accompanied by pain in urine and sexual pain and other symptoms; Leucorrhea increased.
~Physical signs: Vulva flushing, edema, visible scratches or chaps, white membrane attached to the inner side of the labia minora and the vaginal mucosa, more white bean residue like secretions can be seen in the vagina, which can be curd.
~Samples are human vaginal secretions. Each sample should be the amount on one swab.
~The sample is not in menstrual period. The sample subjects did not have vaginal irrigation, medication or sexual intercourse within 3 days."
15735058|NCT04984447|Device|TNIB Catheter|Subjects will be asked to fast for 8 hours prior to study procedure and no liquids 2 hours prior to study procedure. Lidocaine jelly will may be used to help insert the TNIB Catheter through the Nares. Once inserted past the pharynx, imaging will begin. We will attempt to image the duodenum within 3 hours of study procedure starting.
15735059|NCT04984434|Drug|F182112|Eight dose cohorts: 0.01, 0.1, 0.3, 1, 3, 10, 20 and 30 μg/kg) d1 treat every weeks.
15735060|NCT04984421|Behavioral|Healthy School Start|The Healthy School Start program is a universal 4-component family support program for children starting school (5-7 years of age) promoting healthy dietary habits and physical activity in the home environment to prevent childhood obesity and parents' risk of developing type 2 diabetes. It is targeting both children and parents.
15735061|NCT04984408|Biological|BBIBP-CorV - Inactivated SARS-CoV-2 vaccine (Vero cell)|"The Inactivated SARS-CoV-2 vaccine (Vero cell)- BBIBP-CorV manufactured by Beijing Institute of Biological Products (BIBP), China National Biotec Group (CNBG), Sinopharm, Beijing, People's Republic of China
~Dose formulation: A liquid formulation containing 4μg total protein with aluminum hydroxide adjuvant (0·45 mg/mL) per 0·5 mL (2-dose schedule followed by a booster dose).
~Mode of Administration: Intramuscular
~Storage Conditions: 2 to 8 degree Celsius"
15735062|NCT04984408|Biological|influenza season quadrivalent Influenza Vaccine (Flu Quadrivalent)|"The southern hemisphere for the 2021 influenza season quadrivalent Influenza Vaccine (Flu Quadrivalent)
~Dose formulation: Purified Inactivated Influenza Virus Antigen H1N1, H3N2, Yamagata and Victoria (single dose, 0.5ml for adults)
~Mode of Administration: Intramuscular
~Storage Conditions: 2 to 8 degree Celsius"
15735063|NCT04984395|Diagnostic Test|Post-treatment CT-guided bone marrow biopsy|At post-treatment, 12 +/- 3 weeks after initiating treatment, patients will undergo a CT guided bone marrow biopsy of the same lesion as baseline.
15735064|NCT04984382|Behavioral|Standardized training on Helicobacter pylori eradication treatment|Standardized training on Helicobacter pylori eradication treatment
15735065|NCT04984369|Drug|HLX208|HLX208 450mg bid po
15735066|NCT04984369|Drug|Cetuximab Injection [Erbitux]|Cetuximab 500 mg/m2 IV Q2W
15735067|NCT04984356|Biological|WU-CART-007|A single IV infusion of WU-CART-007 Cells on Day 1
15735069|NCT04984330|Drug|Selinexor|Selinexor will be given orally at a dose of 60mg once weekly on the first day of the week (day 1, 8, 15, and 22) for Cycle 1 and up to Cycle 12.
15735070|NCT04984330|Drug|Dexamethasone|Dexamethasone will be given orally at a dose of 20mg, if tolerated, or at a reduced dose if required, 30 to 60 minutes prior to selinexor for first 2 days of each week only (days 1, 2, 8, 9, 15, 16, 22, and 23 of each cycle).
15735072|NCT04984304|Behavioral|Lifestyle modifications and Antireflux diet|Patients in Arm 1 - mild cough only slightly worsening the quality of life (VAS 1-3) will undergo treatment using lifestyle modifications and an Antireflux diet for 3 months.
15735073|NCT04984304|Diagnostic Test|Extraesophageal reflux diagnostic|Patients in Arm 2 - moderate and severe cough that significantly worsen the quality of life (VAS 4-10) will undergo extraesophageal reflux diagnostics consisting of esophageal 24-hour pH/Impedance Reflux Monitoring and peptest study on fasting
15735074|NCT04984291|Device|Alliance Glenoid|Alliance Glenoid used in Primary or Revision Total Shoulder Arthroplasty
15735075|NCT04984278|Drug|Nabiximols|oromucosal spray
15735076|NCT04984278|Drug|Placebo|oromucosal spray
15735077|NCT04984265|Radiation|Stereotactic Body Radiation Therapy|SBRT targeting the area of the circuit of Ventricular Tachycardia
15735078|NCT04984252|Behavioral|Self-compassion comprising compassionate body scan-1, compassion body scan-2 and short noticing practice|This intervention includes 3 short meditations that are identified as the active component in the previous study (ID: NCT04665167)
15735079|NCT04984252|Behavioral|Self-compassion comprising self-compassion break, loving kindness meditation, and breathing exercise.|This intervention includes 3 short meditations that are identified as the inactive component in the previous study (ID: NCT04665167)
15735080|NCT04984252|Behavioral|Distraction group|Participants will be asked to listen recording on irrelevant topic.
15735184|NCT04983394|Other|Virtual Realty Exercises|motion-controlled video game
15735081|NCT04984239|Behavioral|Acceptance and Commitment Therapy for aphasia|The intervention will consist of Acceptance and Commitment Therapy modified to meet the needs of stroke survivors with aphasia, combined with communication strategy training.
15735082|NCT04984226|Drug|Veverimer|Veverimer is an orally administered, non-absorbed polymer selectively binding hydrochloric acid from the gastrointestinal tract safely elevating endogenous serum bicarbonate levels.
15735083|NCT04984226|Drug|Sodium bicarbonate|Standard baking soda delivering an exogenous alkali load to increase serum bicarbonate.
15735084|NCT04984226|Drug|Veverimer placebo|microcrystalline cellulose, National Formulary Grade
15735085|NCT04984226|Drug|Sodium bicarbonate placebo|Cornstarch
15735086|NCT04984213|Device|Karma Posterior Fixation Device|Posterior Fixation
15735087|NCT04984200|Procedure|Retinal imaging|Subjects will undergo retinal imaging before and/or after administration of mydriatic agent
15735088|NCT04984200|Drug|Mydriatic Agent|Subjects will be administered mydriatic medication to dilate their pupils.
15735089|NCT04984187|Other|high intensity laser plus exercise|high intensity laser plus exercise
15735090|NCT04984187|Device|high intensity laser only|high intensity laser only
15735091|NCT04984187|Other|exercise|exercise only
15735092|NCT04984161|Other|education|The aim of this project is to examine the effect of stoma care education on the knowledge and skill levels of pediatric surgery nurses about stoma care.
15735093|NCT04984148|Diagnostic Test|CT|Contrast-enhanced thoracic computed tomography
15735094|NCT04984135|Procedure|Percutaneous coronary intervention|All patients were treated with a loading dose of clopidogrel 300 or 600 mg before the procedure followed by maintenance clopidogrel 75 mg daily for 6 months. 100 U/ kg of unfractionated heparin was injected intravenously to maintain an activated clotting time ≥ 250 s during the procedure. For DCB treatment, the patient underwent predilation with an optimal-sized balloon (non-compliant balloon or cutting balloon) based on angiography (balloon-to-vessel ratio of 1.0), with the standard balloon shorter than the intended DCB size. The DCB was sized at 1:1 balloon-to-vessel ratio, delivered rapidly (median of 15 s) and inflated at nominal pressure for 60 s.
15735095|NCT04984122|Procedure|LEEP|According to the size of the cervix, a loop electrode size was selected. The electrical power for the loop electrode was set to 50 W cut and 45 W coagulation in blended mode. LEEP was performed by carefully passing the loop around the transformation zone from 12 o'clock to 6 o'clock. An additional top-hat excision was performed in patients with a lesion deep in the cervical canal. After completion of the excision, hemostasis was exclusively obtained using the ball electrode in spray coagulation mode. No suturing or other methods were used for hemostasis.
15735096|NCT04984109|Procedure|Sham PENG block|The regional block will be performed with the patient in the supine position in operative area with adequate groin exposure. The probe will first be placed at the anterior superior iliac spine in transverse plane, and then will be moved caudally to identify anterior inferior iliac spine (AIIS). The probe will be then rotated to align the AIIS and iliopubic eminence (IPE). This will reveal the iliopsoas tendon and muscle together with femoral vessels superficially. A 22-G 100-mm echogenic needle will be inserted in-plane from lateral to medial, and the tip will be kept at the midpoint of AIIS and IPE deep to psoas tendon. After lifting of psoas tendon by hydrolocation, the patients in PENG group will receive 1 mL of normal saline.
15735097|NCT04984109|Procedure|Real PENG block|The regional block will be performed with the patient in the supine position in operative area with adequate groin exposure. The probe will first be placed at the anterior superior iliac spine in transverse plane, and then will be moved caudally to identify anterior inferior iliac spine (AIIS). The probe will be then rotated to align the AIIS and iliopubic eminence (IPE). This will reveal the iliopsoas tendon and muscle together with femoral vessels superficially. A 22-G 100-mm echogenic needle will be inserted in-plane from lateral to medial, and the tip will be kept at the midpoint of AIIS and IPE deep to psoas tendon. After lifting of psoas tendon by hydrolocation, the patients in PENG group will receive 20 ml of (0.25%) bupivacaine with 0.2 mg/mL dexamethasone that will be injected in 5 ml aliquots after negative aspiration.
15735098|NCT04984083|Dietary Supplement|vitamin k|patients will take vitamin k 10 mg/ml once daily orally or IM between four and 96 hours before elective cesarean section
15735099|NCT04984070|Drug|Oral Contraceptives, Combined|One of the three medications like ethinylestradiol (35 μg) and cyproterone acetate, drospirenone and ethinylestradiol tablets (I) and (Ⅱ) will be used as an antiandrogen.
15735100|NCT04984070|Drug|Metformin Pill|Metformin is used to lower insulin resistance or to modulate hyperinsulinism.
15735101|NCT04984070|Other|lifestyle intervention|Weight control including calorie restriction and moderate exercise will be recommended to obese PCOS patients
15735102|NCT04984057|Drug|PS is stopped when the pressure is equal between bPDA and aPDA.|PS is given and stopped when the pressure is equal between bPDA and aPDA. the pressure is measured using ultrasound
15735103|NCT04984057|Drug|PS is given according to the 2019 European RDS management guideline|PS is given according to the 2019 European RDS management guideline
15735104|NCT04984044|Dietary Supplement|Vitamin D3|"Dietary supplement:Vitamin D3
~1 capsule of Vitamin D3 (40,000IU) weekly for 8 weeks with antidiabetic drug"
15735105|NCT04984044|Dietary Supplement|Placebo|1 capsule weekly for 8 weeks with antidiabetic drug
15735106|NCT04984031|Diagnostic Test|ELISA assessment of apoptosis markers in gingival crevicular fluid|Gingival crevicular fluid (GCF) samples will be collected to assess the level of caspase-3,8,9 and apoptosis inducing factor (Aif)
15735107|NCT04984018|Drug|chidamide + camrelizumab|Pts received 200 mg camrelizumab intravenously every 2 weeks and Chidamide 30mg orally twice (biw) per week for 4 consecutive weeks every 6 weeks until disease progression, unacceptable adverse events (AEs) or withdrawal of consent.
15735108|NCT04984005|Behavioral|Low intensity exercise training|The exercise method is broadcast gymnastics and sports dance. Through the design of different exercise intensities, This arm receives a low-intensity exercise training.
15735109|NCT04984005|Behavioral|Moderate intensity exercise training|The exercise method is broadcast gymnastics and sports dance. Through the design of different exercise intensities, This arm receives a moderate-intensity exercise training.
15735110|NCT04984005|Behavioral|Intermittent high intensity exercise training|The exercise method is broadcast gymnastics and sports dance. Through the design of different exercise intensities, This arm receives a high-intensity exercise training.
15735185|NCT04983394|Other|Aerobic exercises|cycling activity
15735111|NCT04983992|Procedure|extracapsular release of lateral retinaculum|A new kind of surgery releases the lateral retinaculum from outside the knee capsular, maintaining the structure of the knee capsular.
15735112|NCT04983979|Drug|Sodium Zirconium Cyclosilicate|sachets of 5g or 10g given OD titrated to serum potassium
15735113|NCT04983979|Drug|Placebo|matched placebo given titrated according to potassium at a dose to 5 or 10g
15735114|NCT04983966|Drug|Desﬂurane|"General anesthesia for patients will be inducted and maintained with desflurane inhalation and remifentanil infusion.
~Remimazolam group will be started with remiamazolam at 6 mg/kg/h and TCI Minto model of remifentanil for the time of anesthesia induction, and maintained at 0.5"
15735115|NCT04983966|Drug|Remimazolam|"General anesthesia for patients will be inducted and maintained with desflurane inhalation and remifentanil infusion.
~Remimazolam group will be started with remiamazolam at 6 mg/kg/h and TCI Minto model of remifentanil for the time of anesthesia induction, and maintained at 0.5"
15735116|NCT04983953|Device|cHS|Clinical decision support system for diagnosing intracranial haemorrhage
15735117|NCT04983940|Drug|Jatenzo|237 mg soft gel capsule taken twice a day by mouth with food.
15735118|NCT04983927|Device|cASPECTS|Clinical decision support system for scoring ASPECTS score
15735119|NCT04983914|Device|Transcorneal Electrostimulation via OkuStim System|Transcorneal electrostimulation, usually applied once per week for 30 min (home-use).
15735120|NCT04983901|Drug|Cefepime|Given IV
15735121|NCT04983901|Drug|Imipenem/cilastatin-relebactam|Given IV
15735122|NCT04983901|Drug|Daptomycin|Given IV
15735123|NCT04983901|Drug|Linezolid|Given IV or PO
15735124|NCT04983901|Drug|Meropenem|Given IV
15735125|NCT04983901|Drug|Piperacillin-Tazobactam|Given IV
15735126|NCT04983901|Drug|Vancomycin|Given IV
15735128|NCT04983875|Behavioral|BAC-Enhanced Letter|The BAC-Enhanced Letter intervention includes enhancing the standard mammography results letter with a few additional lines of text informing patients of their personal BAC status.
15735129|NCT04983875|Behavioral|Waitlist Control|Patients randomized to this group will receive a standard post-mammography results letter which does not include any information about their personal BAC status. However, participants randomized to this group will be informed of their personal BAC findings at the end of their study participation (approximately 6 months after mammography).
15735132|NCT04983849|Drug|metronidazole hydrogel|scaling and root planning in adjunct to the use of metronidazole in the periodontal pocket
15735133|NCT04983849|Procedure|scaling and root planning|scaling and root planning
15735134|NCT04983836|Procedure|Serratus anesthesia technique|locoregional anaesthesia allowing analgesia of the hemi-thorax by ultrasound guided single injection of naropeine 5mg/ml
15735135|NCT04983836|Procedure|Paravertebral anesthesia technique|Ultrasound guided single injection of of naropeine 5mg/ml dose into the paravertebral space next to the thoracic spine
15735136|NCT04983823|Other|Heart Failure intervention (Cardiac COVID Disease Management Plan (CC-DMP)|A clinical review to ensure optimal risk factor control and cardioprotection along with exercise intervention.
15735137|NCT04983823|Other|Usual care|This will be provided by participants' usual healthcare professional(s).
15735138|NCT04983810|Drug|Fadraciclib|Fadraciclib is a highly selective, orally- and intravenously- available, 2nd generation amino-purine inhibitor of CDK2 and CDK9.
15735139|NCT04983797|Device|OPTRELL Mapping Catheter|Participants scheduled to have a clinically-indicated catheter mapping and ablation using OPTRELL mapping catheter for the management of Atrial procedure (Scar-related Atrial Tachycardia, Persistent Atrial Fibrillation, Paroxysmal Atrial Fibrillation) and Ventricular procedures (Ventricular Tachycardia, Premature Ventricular Complex).
15735140|NCT04983784|Behavioral|walking|walking for 12 weeks at home
15735141|NCT04983784|Other|Routine care|Routine care
15735142|NCT04983771|Device|Annotate ultrasound scans|Each expert will be asked to hand-labelled anatomical structures on relevant ultrasound images
15735143|NCT04983758|Other|Oral Rehabilitation with dental implants|Patients have been treated with oral dental implants supporting fixed dental prostheses
15735144|NCT04983745|Drug|Combination drug|niraparib and dostarlimab combination
15735145|NCT04983732|Drug|FL-101-Intravenous|150 mg administered via the IV route
15735146|NCT04983732|Drug|FL-101-Subcutaneous|150 mg administered via the SC route
15735147|NCT04983706|Procedure|MRI/Ultrasound Fusion Saturation Biopsy|MRI/Ultrasound fusion saturation biopsy: the core number and location are designed according to the lession condition.
15735148|NCT04983693|Behavioral|Dementia-friendly Worship Service|Key elements of dementia-friendly worship services include familiar hymns, prayers and bible stories and short sermons. Participants can attend the worship services either in person or through online video streaming. Participant dyads should watch the six worship services together, over a span of 6 to 8 weeks.
15735149|NCT04983680|Behavioral|MBCT|Mindfulness-Based Cognitive Therapy (MBCT) is an 8-week group intervention (1.5-hour weekly sessions) that combines cognitive-behavioral therapy and mindfulness training. In this study, MBCT has been adapted to include education about cardiac health and fear of recurrence, and the intervention is delivered remotely via synchronous group videoconference. There is 15-20 minutes of daily mindfulness practice between sessions. Participants are provided a home practice record form and asked to submit the completed form to study staff each week.
15735150|NCT04983667|Dietary Supplement|Zn-AA|Oral supplementation of either 30 mg daily or Zinc-AA complex or placebo, from the study recruitment during first trimester of pregnancy, all through pregnancy and up to the sixth month after giving birth.
15735186|NCT04983394|Other|conventional exercises|stretching, strengthening and endurance exercises
15735277|NCT04982640|Behavioral|Standard Exercise|60 minutes, twice weekly for 12 weeks, group-based walking program
15735151|NCT04983654|Diagnostic Test|patients with limb ulcers|"For patients with limb ulcers : at inclusion visit and after healing or at 6 months if ulcer does not heal:
~Microvascular analysis (laser doppler, TcPO2),
~Neurological analysis ( sensitivity testing with thermal and mechanical test),
~Analysis of physical characteristics of red blood cells and inflammatory marks,
~Analysis of cytokine and metalloproteases in the wound fluid,
~Assessment of healing according usual treatment"
15735152|NCT04983654|Diagnostic Test|For patients without limb ulcers|"For patients without limb ulcers : at inclusion visit only
~Microvascular analysis (laser doppler, TcPO2),
~Neurological analysis (sensitivity testing with thermal and mechanical test),
~Analysis of physical characteristics of red blood cells and inflammatory marks"
15735153|NCT04983641|Other|Pre-Visit Messages|"Patients in both experimental arms (E-mail and Digital Patient Portal MyChart) were sent pre-visit messages regarding PROMIS form completion via each respective modality at 1 week and also 3 days prior to their respective Orthopaedic clinic visits"
15735154|NCT04983628|Other|Tumor molecular profiling|targeted DNA NGS
15735155|NCT04983615|Drug|fentanyl-based sedation|fentanyl-based sedation instead of midazolam-based sedation in ventilated patients
15735156|NCT04983615|Drug|midazolam-based sedation|midazolam-based sedation
15735157|NCT04983602|Other|Comprehensive Geriatric Assessment arm|The intervention will involve a comprehensive geriatric assessment which will be provided by a geriatric doctor, physiotherapist, occupational therapist, social worker, pharmacist and specialist nurse.,
15735158|NCT04983602|Other|EDPLUS|EDPLUS involves a 6 week physiotherapy led community based intervention involving 3 home visits and weekly telephone support.
15735161|NCT04983576|Procedure|spinal fusion|patients undergoing spinal fusion
15735162|NCT04983563|Device|Actigraphy, eTact|Actigraphy will be realized twice a day during 30 minutes and Lipsitz scoring system will be realized at the same moment to analyze the correlation between Lipsitz scoring system and actigraphy.
15735163|NCT04983550|Drug|SG001|Recombinant Anti-PD-1 Fully Human Monoclonal Antibody Injection, 240 mg q2w
15735164|NCT04983550|Drug|Doxorubicin hydrochloride liposome injection|Doxorubicin hydrochloride liposome injection 40mg/m ^2 q4w
15735165|NCT04983537|Drug|Gam-COVID-Vac / Gam-COVID-Vac|A comparison of antibody levels against protein S will be performed using the Gam-COVID-Vac / Gam-COVID-Vac group as a control group and the Gam-COVID-Vac / ChAdOx1 nCoV-19 and Gam-COVID-Vac / BBIBP-CorV groups as comparators.Comparisons will be made by contrasting the geometric means of antibody levels between each of the study arms. In addition, comparisons will be made as to whether or not the median antibody values of the alternative treatment groups are lower than: a) the 25th percentile of the median antibody value of the Gam COVID combination and b) whether the lower limit of the confidence interval of the differences in the GMC rate is lower than the conventional cut-off point of non-inferiority set at 0.67.
15735166|NCT04983524|Dietary Supplement|propolis|resinous product of honeybees
15735167|NCT04983524|Drug|Calcium Hydroxide|Gold standard control intracanal medicament
15735168|NCT04983511|Diagnostic Test|Electrical Epidural Stimulation Test (EST)|EST measures sensory/motor responses
15735169|NCT04983498|Drug|Ondansetron 4 MG|PONV prophylaxis for participants with an apfel score of 2 or greater (ondansetron 4 mg IV), an additional dose of ondansetron 4mg IV will be available in recovery if the patient has nausea/vomiting despite prophylaxis.
15735170|NCT04983498|Drug|Lactated Ringers, Intravenous|Goal directed IV fluids to be administered starting preop per the NMH Colorectal ERAS protocol (LR @ 5mL/kg/hr).
15735171|NCT04983498|Other|Early Mobilization|Patient transferred up to the chair (within 5-30 minutes of admission to the recovery room) based on nursing parameters and patient safety.
15735172|NCT04983498|Other|Early PO Intake|Patient will be offered PO intake within 15-30 minutes of admission to the recovery room post-procedure based on nursing parameters and patient safety.
15735173|NCT04983485|Other|Observational|Respiratory muscle electromyographic activations of individuals will be evaluated during the test while breathing rapidly and deeply from the beginning of the constant threshold load endurance test and the increasing threshold load endurance test until the end of the test, and at rest. Respiratory muscle endurance will be evaluated with constant threshold load endurance test and increasing threshold load endurance test, respiratory functions with pulmonary function test, respiratory muscle strength with intraoral pressure measurement device, health condition disorder with Chronic Obstructive Pulmonary Disease Assessment Scale, dyspnea with Modified Medical Research Council Dyspnea Scale and Modified Borg Scale. Participants' names, anthropometric measurements, demographic data, contact information and medical history will be collected and recorded with the patient anamnesis form.
15735174|NCT04983472|Other|Observational|Respiratory muscle electromyographic activations of individuals will be taken during supine, normal sitting and dyspnea reduction positions. Individuals with chronic obstructive pulmonary disease will be asked to perform normal breathing, pursed lip breathing, and breathing control during these positions. Respiratory muscle activation measurement of individuals will be taken during different breathing patterns in each position. Respiratory functions will be evaluated with pulmonary function test, respiratory muscle strength, intraoral pressure measurement device, respiratory muscle activation with surface electromyographic device, health status disorder with Chronic Obstructive Pulmonary Disease Assessment Scale, dyspnea with Modified Medical Research Council Dyspnea Scale and Modified Borg Scale. Participants' names, anthropometric measurements, demographic data, contact information and medical history will be collected and recorded with the patient anamnesis form.
15735175|NCT04983446|Drug|Foralumab|Foralumab is a second generation fully human anti-CD3 antibody
15735176|NCT04983446|Other|Placebo|Placebo will be the vehicle for the foralumab nasal solution without active drug (25 mM sodium acetate/125 mM sodium chloride/0.02% polysorbate 80, pH 5.5 buffer).
15735177|NCT04983420|Other|non-alcoholic Pilsner|intake of 1 L non-alcoholic Pilsner per day for 2 weeks
15735178|NCT04983420|Other|non-alcoholic wheat beer|intake of 1 L non-alcoholic wheat beer per day for 2 weeks
15735179|NCT04983420|Other|apple spritzer|intake of 1 L apple spritzer per day for 2 weeks
15735180|NCT04983420|Other|lemonade|intake of 1 L lemonade per day for 2 weeks
15735181|NCT04983407|Drug|AVB-S6-500|AVB-S6-500 is experimental drug
15735182|NCT04983407|Drug|Nab paclitaxel|Nab paclitaxel is active comparator
15735183|NCT04983407|Drug|Gemcitabine|Gemcitabine is active comparator
15735187|NCT04983381|Other|Multimedia education video|The multimedia education video was a 30 minutes information-based patient education program and contained information about pelvic anatomy and how to practice vaginal examination. The same gynecologist (M.S.) (male) who 15 years of experience explained details of vaginal examination, who told about vaginal examination in this video to the study participants, also did the gynecologic examination. The gynecologic examination which contained pelvic ultrasound scan and vaginal examination lasted approximately 20 minutes practice.
15735191|NCT04983355|Dietary Supplement|Fish Hydrolysate|"The participants take 4 capsules/day of the study product. Two capsules should be consumed orally every morning with breakfast and/or with a glass of (plain, not sparkling) water and not with fruit juice or hot food/drink while ingesting the capsules; and two capsules should be consumed orally every evening with their dinner and/or with a glass of water.
~Participants receiving the fish hydrolysate the fourth first weeks will then receive the placebo during another 4 weeks. A wash-out period of 4 weeks is included between each phase of supplementation."
15735192|NCT04983355|Dietary Supplement|Placebo|"The participants take 4 capsules/day of the study product. Two capsules should be consumed orally every morning with breakfast and/or with a glass of (plain, not sparkling) water and not with fruit juice or hot food/drink while ingesting the capsules; and two capsules should be consumed orally every evening with their dinner and/or with a glass of water.
~Participants receiving the Placebo the fourth first weeks will then receive the fish hydrolysate during another 4 weeks. A wash-out period of 4 weeks is included between each phase of supplementation."
15735193|NCT04983342|Device|Apollo Armband|The Apollo armband is approximately the size of an Apple Watch and can be worn on the ankle, wrist, or arm with two adjustable fabric straps. Apollo vibrations activate touch receptors in the skin and are perceived as safety signals by the brain resulting in decreased stress, improved recovery, focus, and energy, combatting fatigue and pain. In addition to the wearable, Apollo is a software system that curates music for the body, rather than for the ears.
15735194|NCT04983329|Other|Telemedicine intervention|Following education, the telemedicine center will subsequently monitor operating rooms included in this trial for protocol adherence for three-months. The telemedicine center is staffed by attending anesthesiologists, resident anesthesiologists, certified registered nurse anesthetists (CRNAs) and student registered nurse anesthetists (SRNAs) and is currently providing evidence-based support to clinicians in a subset of operating rooms and post-anesthesia care unit (PACU) beds at BJH.
15735195|NCT04983303|Other|TICK-B group|These interventions will distract the child during venipuncture
15735196|NCT04983290|Dietary Supplement|weancare-domus|Participants belonging to the experimental group will receive at home a set of foods that allows to receive the right amount of proteins and energy in a modified texture form to be prepared by themselves or by their caregivers
15735197|NCT04983277|Other|no intervention|no intervention
15735198|NCT04983264|Drug|GBT021601|Tablets and capsules which contain GBT021601 drug substance
15735199|NCT04983238|Drug|BYON5667 & SYD985|Ocular administration: BYON5667, Intravenous administration: SYD985
15735200|NCT04983238|Drug|Placebo & SYD985|Ocular administration: Placebo, Intravenous administration: SYD985
15735201|NCT04983225|Drug|Human Dental Pulp Stem Cells|Investigational drugs: based on initial periodontal therapy (supragingival cleansing, subgingival scaling and root planning), human dental pulp stem cell injection will be given for a single local injection;
15735202|NCT04983225|Other|Saline solution|Blank control: initial Basal periodontal therapy (supragingival cleansing, subgingival scaling and root planning) followed by a single local injection of normal saline.
15735203|NCT04983212|Other|periodontal control|patient were called and visited in the dentistry department and gingival sulcus were gentle probed to assess gingiva and peri-implant tissues status
15735204|NCT04983199|Device|Hexoskin Medical System|Hexoskin is a smart shirt that can detect heart rates, lung function and physical activity of patients before and after radiotherapy.
15735205|NCT04983186|Device|Wearable sensor and smartphone application|Empatica E4 wearable sensor and custom-made headache smartphone application
15735206|NCT04983173|Drug|Ovarian Stimulation with CC+rFSH|: CC 50 mg/day (Omifin®) + rFSH 150 IU (Ovaleap®) GnRH antagonist: ganirelix 0.25 mg (Orgalutran®) Recombinant human chorionic gonadotropin (rhCG) 250 μg (Ovitrelle®) micronized progesterone 200 mg 3id (Utrogestan®)
15735207|NCT04983173|Drug|Ovarian Stimulation with rFSH|rFSH 300 IU rFSH (Ovaleap®) GnRH antagonist: ganirelix 0.25 mg (Orgalutran®) Recombinant human chorionic gonadotropin (rhCG) 250 μg (Ovitrelle®) micronized progesterone 200 mg 3id (Utrogestan®)
15735208|NCT04983160|Drug|Allopurinol|Allopurinol
15735209|NCT04983160|Drug|Placebo|Placebo
15735210|NCT04983147|Other|Obesity Training Based on Health Belief Model|Trainig was given with initiatives for cognitive and affective learning areas within the framework of health belief model.7 weeks.This application will only be made in the experimental group.
15735211|NCT04983147|Other|Post-training follow-up|"After 7 weeks of training to women were completed, women were included in the follow-up program.For 6 mounts. This application will only be made in the experimental group.It will be made by phone call.
~This follow-up will increase motivation and answer questions regarding obesity management.
~It was made by calling every 15 days."
15735212|NCT04983134|Behavioral|Enhanced CHW Intervention|community-based intervention
15735243|NCT04982913|Drug|HEC116094|Part B：Mulltiple doses up to 5 days； Part C：Each cycle was administered for 5 days
15735278|NCT04982640|Behavioral|Nutrition Counseling|One, 30-minute session with registered dietitian
15735279|NCT04982627|Behavioral|BNI Chatbot|The BNI Chatbot is a web application that guides participants through a brief motivational intervention that motivates them to engage in treatment for opioid use disorder.
15735280|NCT04982627|Behavioral|OUD Education & Treatment Resources|The OUD Education & Treatment Resources intervention is a web application that provides OUD education and treatment resources.
15735315|NCT04982354|Biological|CD34+ selected allogeneic stem cell transplant from an HLA-compatible donor|Allogeneic stem cell transplant infused intravenously
15735213|NCT04983121|Drug|Next-generation Site-specific human epidermal growth factor receptor 2 (HER2)-targeting Antibody-drug Conjugate (ARX788)|The subjects who sign an informed consent will enter the treatment period after screening. Each eligible subject will receive pyrotinib, 320 mg once a day, with 21 days as a session, for 6 sessions in total before operation. Next-generation Site-specific human epidermal growth factor receptor 2 (HER2)-targeting Antibody-drug Conjugate (ARX788) will be intravenously injected at a dose of 1.5 mg/kg, once every 3 weeks, with 21 days as a session, for 6 sessions before surgery. Breast MRI and other imaging examinations will be reviewed every 2 sessions to evaluate the curative effect, and the patient's baseline will be defined based on the imaging report at the time of enrollment. If a definite effect (complete response/partial response) is achieved, surgical treatment will be performed within 4 weeks (> 2 weeks) after completion of 6 sessions of neoadjuvant therapy.
15735214|NCT04983108|Other|No Intervention|No intervention. This is an observational Study
15735215|NCT04983095|Radiation|stereotactic body radiotherapy|30 Gy in 3 fractions alternatively 40 Gy in 5 fractions delivered with stereotactic radiotherapy-principles
15735216|NCT04983095|Drug|androgen deprivation therapy|Medical castration
15735217|NCT04983095|Radiation|Radiotherapy|RT to the prostate for de novo patients
15735218|NCT04983056|Procedure|Necrotesectomy associated with cleanleness stoma|Excision of all necrotised tissues after stool diversion and wound dressing using
15735219|NCT04983043|Drug|Low dose Qishenyiqi Dripping Pills 3 bags|Low dose Qishenyiqi Dripping Pills contain Qishenyiqi dripping pills 2 bags(0.52g dripping pills per bag) and Qishenyiqi dripping pills placebo 1 bag(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks
15735220|NCT04983043|Drug|High dose Qishenyiqi Dripping Pills 3 bags|High dose Qishenyiqi Dripping Pills contain Qishenyiqi dripping pills 3 bags(0.52g dripping pills per bag),take orally after meals, 3 times a day for 12weeks
15735221|NCT04983043|Drug|Qishenyiqi Dripping Pills placebo 3 bags|Qishenyiqi Dripping Pills placebo contain Qishenyiqi dripping pills placebo 3 bags(0.52g dripping pills placebo per bag),take orally after meals, 3 times a day for 12weeks
15735222|NCT04983030|Biological|Ad26.Mos4.HIV|Ad26.Mos4.HIV is a tetravalent vaccine containing Mos1.Env, Mos2S.Env, Mos1.Gag-Pol, and Mos2.Gag-Pol HIV-1 proteins.
15735223|NCT04983030|Biological|MVA-BN-HIV|MVA-BN-HIV is a monovalent vaccine comprising a single Modified Vaccinia Ankara - Bavarian Nordic (MVA-BN®) vector encoding Mos1.Env, Mos2S.Env, Mos1.Gag-Pol, and Mos2.Gag-Pol HIV-1 proteins.
15735224|NCT04983030|Biological|PGT121|PGT121 is a human mAb that targets the HIV-1 V3 glycan, centered on N332.
15735225|NCT04983030|Biological|PGDM1400|PGDM1400 is a human mAb that targets the HIV-1 V2 glycan, centered on N160.
15735226|NCT04983030|Biological|VRC07-523LS|VRC-HIVMAB075-00-AB (VRC07-523LS) is a human monoclonal antibody (mAb) that targets the HIV-1 CD4 binding site.
15735227|NCT04983017|Dietary Supplement|Dietary supplement|caffeine, iron bisglycinate, manganese chloride, vitamin D2, niacin, guar gum, indole-3-carbinol, L-methionine, piceatannol, biotin, beta-carotene, zinc sulfate
15735228|NCT04983017|Other|Placebo|Matched Placebo to Intervention
15735229|NCT04983004|Behavioral|tele-rehabilitation|According to the pre-arranged case service schedule, the researcher is asked to push the computer and cart to the case ward for installation, and use the communication software to interact with each other in real time. The intervention method directly plays the recorded video to demonstrate the action according to the action needs of the case. The therapist can observe the video demonstration and the actual action execution of the case at the same time from the screen.
15735230|NCT04983004|Behavioral|bedside rehabilitation|The bedside therapist and the case work together to set an activity schedule. The case is asked to establish and record daily routine activities, provide basic exercise and activity schedules to avoid degradation and reduce the lack of active participation in activities. The protection is to wear personal protective equipment, including protective clothing, gloves, masks, and face shields, and wash hands and disinfect before and after treatment.
15735231|NCT04982991|Drug|RIPK1 inhibitor|Capsule Oral
15735232|NCT04982978|Behavioral|PMT Threat Appraisal|"The first half of the PMT present video will include narration by Science Insider producer, Benji Jones, including dialogue regarding the risks associated with vaping by Chief Pediatric Pulmonology at the NYU Winthrop Hospital, Dr. Melodi Pirzada, and information on nicotine by the Director of Pediatric Pulmonology at NYU's Langone Hassenfeld Children's Hospital, Dr. Mikhail Kazachkov. The second half of the PMT present video will include personal experiences and narratives by students at the University of Utah with information regarding our current knowledge of vaping health effects through research by Dr. Sean Maddock and Dr. Sean Callahan from the University of Utah to highlight the susceptibility of vaping for a population of young adults in university."
15735233|NCT04982978|Behavioral|General Nutrition and Lifestyle|The first half of the PMT absent video will be presented by the Alliance for Aging Research, including an immersive video design, explaining the impact that nutrition may have as the participants age, reviewed by Dr. Steven Austad and Senior Nutritionist Johanna Dwyer. The second half of the PMT absent video will be presented by TED-Ed with narration by Addison Anderson, including a similar immersive video design, explaining how the food the participants eat may affect our brain and overall health. The nutrition and lifestyle information design will be administered as a control because it provides informative lifestyle choices regarding nutrition that can help promote the participants overall health without having an underlying link to vaping behaviour and its subsequent effect on the status of health.
15735234|NCT04982965|Drug|Active Cannabis|400 mg of vaporized and inhaled active cannabis (5.1%)
15735235|NCT04982965|Drug|Placebo Cannabis|400 mg of vaporized and inhaled placebo cannabis (<.1%)
15735236|NCT04982952|Behavioral|Contingency Management - Increasing|Increasing incentive payment for abstinent participant
15735237|NCT04982952|Behavioral|Fixed payments|Fixed payments for attending study visits
15735238|NCT04982939|Drug|Sintilimab|Sintilimab, 200mg IV d1 Q3W
15735239|NCT04982939|Drug|S-1|S-1, 40-60mg BID d1-14 Q3W
15735240|NCT04982939|Drug|Oxaliplatin|Oxaliplatin，130mg/m2 d1 Q3W
15735241|NCT04982926|Drug|TAS2940|Study participants with solid tumors and EGFR or HER2 aberrations will receive TAS2940 tablets daily at increasing doses until MTD is reached.
15735242|NCT04982926|Drug|TAS2940|Study subjects with select solid tumors characterized by EGFR or HER2 aberrations will receive TAS2940 at the dose identified during Dose Escalation phase.
15735273|NCT04982653|Other|Quality-of-Life Assessment|Ancillary studies
15735244|NCT04982900|Drug|furmonertinib|AST2818 is an irreversible and highly selective EGFR inhibitor independently discovered and developed by Allist. It has the potential to become the best-in-class drug in the third-generation EGFR-TKIs. Data from the preclinical studies and the completed clinical studies show that AST2818 has the following advantages: 1) AST2818 has good target selectivity and tissue distribution specificity; 2) The objective response rate of AST2818 for the patients with locally advanced or metastatic NSCLC with EGFR T790M mutation is outstanding, reaching 74.1% in the key registration clinical study; 3) AST2818 has a good safety profile and is well-tolerated; 4) AST2818 and its active metabolites have a superior ability to penetrate the blood-brain barrier, and have a good therapeutic efficacy on brain metastases frequently seen in patients with NSCLC.
15735245|NCT04982900|Drug|Placebo|The placebo has the same appearance, weight, and physical and chemical properties as the study drug, and is provided by the researcher to the subjects in control group.
15735246|NCT04982887|Other|Exercise|The cervical region is one of the most affected regions of the musculoskeletal system due to the intensive proprioceptors. Studies have shown that many position sense proprioceptors are over the deep group cervical muscles such as longus colitis and longus capitis. The deep group cervical muscles, which perform a dynamic ligament function, have an important role in maintaining the stability of the spine as well as the proprioceptive sense. In particular, proprioceptive receptors, which are commonly found in the deep suboccipital muscles; There are cervical and reflex connections with vestibular, visual and postural control systems.
15735247|NCT04982874|Drug|Furosemide 40 mg|Administered with 240 mL of water
15735248|NCT04982874|Drug|Lasix® 40 mg Tablet|Administered with 240 mL of water
15735249|NCT04982861|Drug|Cefixime Trihydrate 100 mg/5 mL Dry Syrup|Participants received a single dose of 5 mL of cefixime dry syrup with 240 mL of water
15735250|NCT04982861|Drug|Suprax 100 MG in 5 mL Oral Suspension|Participants received a single dose of 5 mL of Suprax with 240 mL of water
15735251|NCT04982848|Drug|Talzenna|Talzenna treatment under Korea regulatory approval indication/dosage
15735252|NCT04982835|Device|M6-C Artificial Cervical Disc|An incision will be made in the front of the neck and the damaged disc located between cervical vertebrae (neck bones) will be removed so that the M6-C artificial cervical disc can be placed into the space where the damaged disc was removed. This procedure will be performed using x-ray technology (fluoroscopy) guide the surgeon in placement of the M6-C in between the cervical vertebrae. This process will be repeated to replace the second damaged disc.
15735253|NCT04982835|Device|ACDF|One of three FDA approved cervical plate systems will be used for the ACDF. An incision will be made in the front of the neck and the damaged disc located between cervical vertebrae (neck bones) will be removed. Then, a piece of donor bone will be placed in the space where the damaged disc was removed and a metal plate will be screwed into the bones above and below the disc. This procedure will be performed using x-ray technology (fluoroscopy) guide the surgeon in placement of the cervical plate system. This process will be repeated to treat the other damaged disc.
15735254|NCT04982809|Drug|Betamethasone, Dexamethasone, Prednisolone|Corticosteroids
15735255|NCT04982796|Drug|Psilocybin|See description of psilocybin-enhanced psychotherapy arm.
15735256|NCT04982796|Behavioral|Treatment-as-usual|See description of treatment-as-usual arm.
15735257|NCT04982770|Other|Survey|Reading of ethical guidelines.
15735258|NCT04982757|Device|MagVenture MagPro System with Brainsight neuronavigation device|10x daily sessions of 1200 pulses of theta-burst stimulation lasting approximately ten minutes.
15735262|NCT04982705|Drug|[Part 1.1] IDG-16177|[Part 1.1] Subjects will receive a single oral dose of IMP. Dose strenght for each cohort (Cohort 1-5) is planned as 0.5, 1, 2, 5, 10mg, respectively.
15735263|NCT04982705|Drug|[Part 1.1] Placebo of IDG-16177|[Part 1.1] subjects will receive a single oral dose of IMP.
15735264|NCT04982705|Drug|[Part 2] Sitagliptin|Administration of Sitagliptin 100mg once daily for 4 weeks.
15735265|NCT04982705|Drug|[Part1.2] IDG-16177|[Part 1.2] Administration once daily for 14 days; Dose strenght for each cohort (Cohort 6-8) is planned as ≤ 2, ≤ 4, ≤ 8mg, respectively.
15735266|NCT04982705|Drug|[Part 2] IDG-16177|[Part 2] Administration once daily for 4 weeks.
15735267|NCT04982705|Drug|[Part 1.2] Placebo of IDG-16177|[Part 1.2] Administration once daily for 14 days.
15735268|NCT04982705|Drug|[Part 2] Placebo of IDG-16177|[Part 2] Administration once daily for 4 weeks.
15735269|NCT04982692|Drug|intravaginal prasterone|6.5 mg of Intravaginal prasterone once daily at bedtime with a finger to insert the vaginal suppository into the vagina for a treatment cycle of 12 weeks.
15735270|NCT04982692|Drug|Placebo ovules|Placebo ovules once daily at bedtime with a finger to insert the vaginal suppository into the vagina for a treatment cycle of 12 weeks.
15735271|NCT04982666|Other|Whole-Food, Plant-Based Diet|This diet is focused on nutritional needs with natural, minimally-processed plant foods.
15735272|NCT04982666|Other|FODMAP Diet|An elimination diet of fermentable, oligosaccharides, disaccharides, monosaccharides and polyols
15735281|NCT04982614|Biological|Gardasil ® 9|"GARDASIL 9 is a vaccine indicated in girls and women 9 through 45 years of age for the prevention of the following diseases: Cervical, vulvar, vaginal, and anal cancer, and Genital warts (condyloma acuminata) caused by Human Papillomavirus (HPV).
~0.5-mL suspension for intramuscular injection as a single-dose vial and prefilled syringe at the following regimen/schedule: 9 through 14 years - 2-dose at 0, 6 to 12 months OR 3-dose at 0, 2, 6 months 15 through 45 years - 3-dose at 0, 2, 6 months"
15735282|NCT04982601|Other|Yoga Exercises|Yoga-based exercises are Hatha yoga-based sessions consisting of breathing exercises, warm-up exercises, relaxation, asanas exercises.
15735283|NCT04982588|Device|Medtronic CoreValve™ Evolut™ PRO System|"The system comprised of the following three components:
~CoreValve™ Evolut™ PRO Transcatheter Aortic Valve (TAV)
~EnVeo™ PRO Delivery Catheter System (DCS)
~EnVeo™ PRO Loading System (LS)"
15735284|NCT04982575|Drug|Semaglutide 2.4 mg|Semaglutide administered s.c. (subcutaneously, under the skin) once weekly. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks
15735285|NCT04982575|Drug|Cagrilintide 2.4 mg|Cagrilintide administered s.c. (subcutaneously, under the skin) once weekly. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks
15735286|NCT04982575|Drug|Placebo (semaglutide)|"Placebo (semaglutide) administered s.c. (subcutaneously, under the skin) once weekly.
~Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks"
15735287|NCT04982575|Drug|Placebo (cagrilintide)|"Placebo (cagrilintide) administered s.c. (subcutaneously, under the skin) once weekly.
~Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 32 weeks"
15735288|NCT04982562|Other|7T MRI|Seven tesla brain MRI (7T MRI) at day 7 in patients suffering from post concussionnal symptoms after mild traumatic brain injury admitted to emergency departement of Poitiers CHU (University Hospital
15735289|NCT04982549|Drug|Durvalumab|Durvalumab (intravenous infusion)
15735290|NCT04982549|Drug|Carboplatin/ Paclitaxel|Carboplatin /Paclitaxel, as per standard of care
15735291|NCT04982549|Drug|Pemetrexed/ Cisplatin|Pemetrexed / Cisplatin, as per standard of care
15735292|NCT04982549|Drug|Pemetrexed/ Carboplatin|Pemetrexed / Carboplatin , as per standard of care
15735293|NCT04982549|Radiation|Radiation|5 fractions/ week for ~6 weeks (±3 days) (Total 60 Gy)
15735294|NCT04982536|Device|VMCore Biopsy System|Prostate Examine
15735295|NCT04982536|Device|Standard of Care Biopsy Needle|Prostate Examine
15735296|NCT04982523|Behavioral|Online Mental Health Program|The proposed program consisted of eight sessions conducted twice per week, consisting of 5 minutes of introductory material, 12-15 minutes of main content, and 5 minutes of concluding content. The main content intended to improve the control processes and each of the four adaptive modes of the RAM. The eight sessions were uploaded on the web. Links and passwords for each session were provided to the participants through SNS. The program was accessible from any electronic device with Internet access
15735297|NCT04982510|Device|complete denture|3D printed complete denture
15735298|NCT04982497|Behavioral|Video game based intervention|The intervention will be administered via an online graphic-adventure video game. It includes 3 components: depression prevention, cognitive stimulation, and healthy habits promotion. The depression prevention component will be adapted from an indicated prevention program based on the model by Lewinsohn et al. (1985). The cognitive stimulation component is based on cognitive reserve (Tucker & Stern, 2011) and neuroplasticity (Shapiro, 2001), the cognitive stimulation model by Spector et al. (2006), and the causes of age-related memory failures (Light, 1991) (e.g., decrease in the processing resources, semantic coding deficit, difficulties in deliberate information retrieval). The healthy habits promotion component is based on the social learning and social cognitive theories (Bandura, 1986; Spiegler, 2016).
15735299|NCT04982497|Other|Control group|The active control group will have access to a platform of online therapeutically inactive information related to active aging.
15735300|NCT04982458|Diagnostic Test|68Ga-FAPI|68Ga-FAPI injection is a radiopharmaceutical used for positron emission tomography (PET) diagnosis. This product is used for PET, qualitative and localized diagnosis and evaluation of abnormal expression of fibroblast-activated protein in focus-associated fibroblasts.
15735301|NCT04982445|Drug|CABENUVA|CABENUVA will be administered IM at infusion centers.
15735302|NCT04982432|Drug|Orismilast|Orismilast is a next generation PD4 inhibitor with demonstrated broad anti inflammatory properties
15735303|NCT04982419|Device|Remote ischemic preconditioning|3 cycles of blood pressure cuff inflations to occlusive pressure of 200 mmHg for 5 minutes and deflation for 5 minutes
15735304|NCT04982419|Device|Sham remote ischemic conditioning|3 cycles of blood pressure cuff inflations to non-occlusive pressure of 60 mmHg for 5 minutes and deflation for 5 minutes (Control)
15735305|NCT04982406|Device|Transcatheter aortic valve replacement|Transcatheter aortic valve replacement
15735306|NCT04982380|Drug|Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, Live|Patients will be instructed to continue current antidiabetic treatment, which should be kept unchanged throughout the trial, and start treatment with Bifidobacterium, Lactobacillus, Enterococcus and Bacillus Cereus Tablets, Live (Siliankang) 3 tablets p.o. tid for 12 weeks.
15735307|NCT04982380|Drug|Siliankang simulating tablets|Patients will be instructed to continue current antidiabetic treatment, which should be kept unchanged throughout the trial, and start treatment with Siliankang simulative tablets 3 tablets p.o. tid for 12 weeks.
15735308|NCT04982367|Device|Sirolimus-eluting balloon catheter|Sirolimus-eluting balloon catheter designed and produced by Acotec
15735309|NCT04982367|Device|Paclitaxel-eluting balloon catheter|Paclitaxel-eluting balloon catheter (trade name:DHALIA)
15735310|NCT04982354|Drug|CPX-351|For this trial, patients will be treated with CPX-351 100 (daunorubicin 44 mg/m2 and cytarabine 100 mg/m2) for 3 doses on days 1, 3 and 5 of one and on days 1 + 3 of a second cycle of induction therapy, depending on response obtained following the first induction. Thereafter, up to 2 cycles of consolidation therapy of 2 doses on days 1 and 3 of daunorubicin 29 mg/m2 and cytarabine 65 mg/m2 will be administered to the patients.
15735311|NCT04982354|Drug|Midostaurin|The FLT3 directed inhibitor, midostaurin, will be given at a dose of 50mg twice daily, starting on day 8 through day 21 of each cycle of CPX-351 until admission for allogeneic stem cell transplant.
15735316|NCT04982341|Procedure|prone position|patients are returned from prone to supine position while receiving oxygenation through HFNC
15735317|NCT04982328|Diagnostic Test|Th17 cytokine profile|Screening for the components of metabolic syndrome
15735318|NCT04982328|Diagnostic Test|Screening for the components of metabolic syndrome|Anthropometric measures including height, weight, waist circumference and hip circumference will be measured in all patients. Results of the routine laboratory tests as part of the standard diagnostic procedure will be collected: CRP, leukocyte count, ratio neutrophils and lymphocytes, hemoglobin, platelet count, urea, creatinine, bilirubin, AST, ALT, GGT, ALP, albumins, fasting glucose.
15735319|NCT04982328|Diagnostic Test|Evaluation of the degree of steatosis|The degree of steatosis will be estimated using the ultrasound and a method for grading steatosis will be measuring the degree of ultrasound attenuation by hepatic fat using a process based on simultaneous transient elastography (TE) which measures the degree of steatosis.
15735320|NCT04982315|Procedure|Standard Acupuncture|The standard acupuncture intervention is based on classical Chinese acupuncture therapy. Participants randomized to standard acupuncture will receive up to 15 acupuncture treatments over 3 months with the total number being determined by the patient and acupuncturist together. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.
15735321|NCT04982315|Procedure|Enhanced Acupuncture|The enhanced acupuncture intervention includes the 3 months of standard acupuncture plus an additional 3 months of maintenance acupuncture. Participants randomized to enhanced acupuncture will receive up to 21 acupuncture treatments over 6 months. The maintenance acupuncture treatment sessions are expected to consist of the same intervention used in the first 3 months of care described in the standard acupuncture arm, plus up to 6 treatments during the maintenance phase. All treatments will include acupuncture needling only. They will be provided at medical facilities or in private acupuncturists' offices.
15735322|NCT04982302|Procedure|Non-surgical periodontal treatment|Subgingival instrumentation with ultrasonic devices and curettes of all periodontal pockets
15735323|NCT04982289|Drug|ALXN1830|Administered as an SC infusion.
15735324|NCT04982289|Other|Placebo|Administered as an SC infusion.
15735325|NCT04982276|Biological|AK104 and AK109|Subjects will receive AK104 and AK109 by intravenous administration.
15735326|NCT04982276|Drug|PTX|Subjects will receive AK104 and AK109 in combination with PTX.
15735327|NCT04982263|Diagnostic Test|Blood coagulation profile|Venous blood sample for measurement of blood coagulation profile
15735328|NCT04982250|Behavioral|formal peer PrEP referral + HIVST delivery|After a brief training, young female PrEP users are encouraged to refer 4 peers using PrEP educational materials (developed in formative research) and HIVST kits (2 kits/peer = 8 kits total)
15735329|NCT04982237|Biological|AK104|IV infusion
15735330|NCT04982237|Drug|paclitaxel|IV infusion
15735331|NCT04982237|Drug|carboplatin|iv infusion
15735332|NCT04982237|Drug|cisplatin|iv infusion
15735333|NCT04982237|Drug|bevacizumab|iv infusion
15735334|NCT04982237|Drug|Placebo|iv infusion
15735335|NCT04982224|Drug|REGN5093-M114|Administered by intravenous (IV) infusion
15735336|NCT04982211|Drug|Propranolol|Oral propranolol hydrochloride capsules, dosed per participant weight
15735337|NCT04982211|Drug|Placebo|Oral placebo capsules, dosed per participant weight
15735338|NCT04982198|Procedure|ROSA assisted TKA|Robotic assisted total knee arthroplasty
15735339|NCT04982172|Drug|Infliximab|Infliximab (Inflectra® [Pfizer]), dosage determined using model-informed precision dosing, intravenously administered
15735340|NCT04982172|Drug|Infliximab|Infliximab, dosage following a dose de-escalation algorithm at the physician's discretion, intravenously administered
15735341|NCT04982159|Other|There is no intervention. This is an observational study.|There is no intervention. This is an observational study.
15735342|NCT04982146|Drug|Bromelin|0.5mg per mL of total tumor volume calculated, administered percutaneously
15735343|NCT04982146|Drug|N-Acetylcysteine|20mg per mL of total tumor volume calculated, administered percutaneously
15735344|NCT04982133|Dietary Supplement|Protein supplementation based on plasma urea concentration every other week or human milk analysis on experiment|"At the time that the doctor decides to start fortification, it will be done according to urea levels in active comparator arm or human milk analysis on experimental group.
~In Group A, fortification at 4% is started, and according to plasma urea control every 15 days the fortification is modified.
~In Group B, fortification is adjusted based on the macronutrient analysis of breast or donated milk."
15735345|NCT04982120|Device|Repris Needle|Injection of Botox
15735346|NCT04982094|Behavioral|Mental Health First Aid and Relationship Building Training|"Relationship Building Training (RBT) is a 2 hour training session conducted live over zoom, that aims to equip business advisors the communications skills they need to enhance trustworthiness and quality of the relationship with their clients.
~Mental Health First Aid (MHFA) is a certified training program. It requires 5-7 hours of online course work followed by 2 x 2.5 hour live zoom sessions, that aims to enhance mental health literacy and teach the skills needed to identify the signs of mental health conditions and to have a conversation with a person who may need professional help.
~Two Booster sessions are delivered 1- and 3-months after the last MHFA session that aims to give participants the opportunity to consolidate their learning and share experiences applying the knowledge/skills gained.
~Participants will also invite 2-3 of their small-business entrepreneur (SME) clients to join the study and complete 3 surveys to provide feedback on the success of the program."
15735347|NCT04982094|Behavioral|Mental Health First Aid|"Mental Health First Aid (MHFA) is a certified training program. It requires 5-7 hours of online course work followed by 2 x 2.5 hour live zoom sessions in addition to online reading, that aims to enhance mental health literacy and teach the skills needed to identify the signs of mental health conditions and to have a conversation with a person who may need professional help.
~MHFA online training is conducted two-weeks before the two MHFA sessions (with a 1 day break in between each MHFA). Two Booster sessions are delivered 1- and 3-months after the last MHFA session. The Booster sessions aims to give participants the opportunity to consolidate their learning and share experiences applying the knowledge/skills gained.
~Participants will also invite 2-3 of their small-business entrepreneur (SME) clients to join the study and complete 3 surveys to provide feedback on the success of the program."
15735414|NCT04981587|Procedure|Strength exercise|Strength exercise protocol for upper and lower limbs, using weights and elastic bands
15735348|NCT04982081|Biological|hiPSC-CM therapy|20 patients with congestive heart failure who met the inclusion and exclusion criteria will be recruited. After being fully informed and signed the informed consent, the patients will be randomly divided into two dosage groups: 100 million cells (10 patients) and 400 million cells (10 patients). Human iPSC-derived cardiomyocytes will be injected into the myocardium through a transcatheter endocardial injection system.
15735349|NCT04982068|Biological|202-CoV low adjuvant dose|standard dose of 202-CoV with low dose CpG / alum adjuvant
15735350|NCT04982068|Biological|202-CoV low antigen dose|low dose 202-CoV with CpG / alum adjuvant
15735351|NCT04982068|Biological|202-CoV standard dose|standard dose 202-CoV with CpG / alum adjuvant
15735352|NCT04982068|Other|Placebo|Normal saline solution
15735353|NCT04982055|Drug|Nadroparin (intravenous Infusion)|Intravenous route of administration over a 4-hours infusion of nadroparin 3800 IU
15735354|NCT04982055|Drug|Nadroparin (subcutaneous group)|Subcutaneous route of administration of nadroparin 3800 IU
15735355|NCT04982042|Other|Pulmonary Rehabilitation|The Pulmonary Rehabilitation Program consists of a combination of aerobic and strengthening exercises, lasting 12 weeks, with a frequency of 3 times a week, always in the morning. Each session consists of active warm-up exercises, upper and lower limb strengthening, aerobic conditioning and stretching exercises. The warm-up phase consists of intercalated calisthenic exercises for different muscle groups, according to each patient's tolerance.
15735356|NCT04982029|Drug|Cannabidiol 100 MG/ML [Epidiolex]|600mg
15735357|NCT04982029|Drug|Placebo|Matching placebo
15735358|NCT04982016|Other|crystal therapy|Infusion of 250ml crystal solution before anesthesia induction
15735359|NCT04982016|Other|colloid therapy|Infusion of 250ml colloid solution before anesthesia induction
15735360|NCT04982003|Other|exercise|10 weekly hour-long classes of drumming to music using large-amplitude, whole-body movements
15735361|NCT04981990|Procedure|Single lung ventilation by double lumen endotracheal tube|Single lung ventilation using double lumen endotracheal tube and isolation of the operated lung during surgery to create ideal surgical field
15735362|NCT04981990|Procedure|Two lung ventilation by conventional single lumen endotracheal tube|Intermittent two lung ventilation so that no significant hypoxia occurs with creating optimum surgical field
15735363|NCT04981977|Behavioral|Care Transitions Intervention|CTI is delivered by a trained Care Transitions Coach (Coach) who works closely with patients to ensure a smooth transition from hospital to home following an acute hospitalization. The patient, caregiver, and Coach work together to maximize the involvement of interdisciplinary experts, ensuring that the appropriate professionals are involved, issues are addressed, goals are understood, and the discharge care plan is executed correctly. There are three aspects to CTI; the first is the initial hospital visit, followed by an in-home visit, concluding with telephone follow-up over a 28-day period. During these visits, the Coach focuses on four conceptual areas, referred to as pillars (i.e., Personal Health Record, Medication Management, Red Flags, and Physician Follow up). The Coach ensures the patient understands and utilizes the Personal Health Record to facilitate communication and ensure continuity of care plan across providers and settings.
15735364|NCT04981977|Behavioral|Care Transitions Intervention and Peer Support|The PS intervention for this study is based upon the principles of motivational interviewing, which is a person-centered, goal-directed method to enhance intrinsic motivation for change by exploring and resolving ambivalence. A recent meta-analysis found the mean effect size for MI to be significantly larger for racial and ethnic minority samples (0.79 vs. 0.26) as compared to non-Hispanic Whites, highlighting its potential benefit and cultural relevance for minority populations. Patients in this arm of the study will receive the 28-day CTI intervention with a 2-month long Peer Support (PS) intervention provided by trained peer educators (PEs).
15735365|NCT04981977|Other|Usual Care|The researchers will follow a control group of patients who meet study inclusion criteria. These older adults will participate in the traditional discharge case-management offered by the hospital where they were admitted and discharged. UC at our three partner hospitals consists of: (1) routine inpatient nurse intake that includes screening about housing, substance abuse, and functional status; (2) medication reconciliation performed by treating practitioners; (3) discharge patient education provided by inpatient nurses; (4) a list of resources for safety-net clinics and community-based services; and (5) for patients with severe chronic illness (e.g. heart failure) there may be a planned home visit by a nurse practitioner.
15735366|NCT04981964|Procedure|Exercise training|both groups received conventional physiotherapy training program, for one hour, three sessions per week, for three successive months, based on neurodevelopmental treatment, composed of approximation of the upper and lower limbs in a regular and rhythmic manner, facilitation of righting, equilibrium and protective reactions, training of postural stability and equal weight shift especially on the affected side, stretching, strengthening exercises for upper and lower limbs and back muscles
15735367|NCT04981951|Drug|Dexmedetomidine|Highly selective α2-adrenergic receptor agonist. With sedative, analgesic, peri-operative sympatholytic and hemodynamic stabilizing properties.
15735368|NCT04981938|Procedure|Lobectomy with pulmonary artery reconstruction|"Lobectomy with pulmonary artery reconstruction under general anesthesia with selective intubation, by postero-lateral thoracotomy in the fifth intercostal space
~Subgroups : different types of pulmonary artery reconstruction such as :
~Tangential vascular reconstruction with direct suture
~Circumferential resection and end-to-end anastomosis
~bypass reconstruction with heterologous biografts, synthetic grafts, or pericardium patch"
15735369|NCT04981925|Behavioral|MBSR treatment|"Participants will complete pre-treatment surveys followed by 8-weekly 2-hour group sessions and one 6-hour retreat (may take place virtually or in-person). Participants will also be asked to practice daily formal mindfulness at home using assigned audio recordings of 30-45 minute guided mindfulness exercises. Participants will complete surveys during treatment as well as after treatment and then at 2 months follow-up."
15735370|NCT04981912|Drug|HDMP + rituximab as a means of debulking prior to initiating venetoclax.|"Patients will receive HDMP + Rituximab for 1 cycle, followed by reassessment of Tumor Burden,
~If Tumor Burden classification is low after HDMP + Rituximab (lymph nodes < 5cm in diameter AND absolute lymphocyte count < 25k/uL), patients will initiate venetoclax dose ramp-up, with ramp-up schedule according to venetoclax package insert.
~Patients who still have a disease burden (lymphadenopathy > 5 cm or ALC > 25k/iL) that meets criteria for medium or high risk of TLS after 1 cycle of HDMP + Rituximab are given the option to repeat a 2nd cycle of HDMP + Rituximab prior to venetoclax dose ramp-up."
15735371|NCT04981899|Drug|Nivolumab|6 infusions of nivolumab at a fixed dose of 40 mg, 14 days apart, and infusion of nivolumab on day 0 of the NICE-40.
15735372|NCT04981899|Drug|Ifosfamide|5000 mg / m2, 24-hour infusion on day 2 of the NICE-40.
15735373|NCT04981899|Drug|Carboplatin|Optimized to get AUC = 5 (max. 800 mg) on day 2 of the NICE-40.
15735374|NCT04981899|Drug|Etoposide|100 mg / m2 intravenously on 1-3 days of the NICE-40.
15735375|NCT04981886|Drug|Netarsudil Ophthalmic|Subjects will be randomly assigned to this group
15735376|NCT04981886|Drug|Bimatoprost Ophthalmic|Subjects will be randomly assigned to this group
15735377|NCT04981860|Drug|Betadine|One drop of 5% Betadine will be administered to the inferior conjunctiva of the eye
15735378|NCT04981860|Drug|Avenova|One drop of 0.01% Avenova will be administered to the inferior conjunctiva of the left eye
15735379|NCT04981847|Behavioral|Dietary Intervention Meetings|Participants will attend classes once per week for 3 months.
15735384|NCT04981821|Behavioral|GO-EXCAP Mobile App|A mobile app delivery platform to deliver an exercise program [Exercise for Cancer Patients (EXCAP©®)]. EXCAP©®) is a progressive walking and resistance exercise program
15735385|NCT04981821|Behavioral|Behavioral Placebo Control|Participants will meet with an oncology nurse (for approximately 60 min) to review the NCI booklet Chemotherapy and You: Support for People With Cancer, which includes facts about chemotherapy and its side effects. They will be provided with NCI online resources to review at home.
15735386|NCT04981808|Device|Telemonitoring|Telemonitoring of CGM and insulin pen data
15735387|NCT04981782|Other|No study specific intervention, regular care.|Chiropractic care (regular care)
15735388|NCT04981769|Diagnostic Test|Covid-19 test|PCR Covid-19 test
15735389|NCT04981756|Other|observation|This observational study does not have any intervention.
15735390|NCT04981743|Dietary Supplement|Nigella Sativa capsule twice daily|investigate the safety and efficacy of Nigella Sativa versus Vitamin D3 versus Nigella Sativa / vitamin D3 combination as supplement for management of COVID-19 .
15735391|NCT04981730|Behavioral|Guided web-based intervention|The guided web-based intervention participants will follow the website's orientation, the curriculum of modules, and professional feedback to complete the intervention during the 10 weeks.
15735392|NCT04981730|Behavioral|Self-guided web-based intervention|The self-guided web-based intervention participants will follow the website's orientation and curriculum of modules to complete the intervention during the 10 weeks.
15735393|NCT04981717|Drug|REGN1908-1909|Subcutaneous (SC) for a total of 5 administrations
15735394|NCT04981717|Drug|Matching Placebo|SC for a total of 5 administrations
15735395|NCT04981704|Drug|Poziotinib|Poziotinib Tablets
15735396|NCT04981704|Drug|Itraconazole|Itraconazole Oral solution
15735397|NCT04981704|Drug|Phenytoin|Phenytoin Capsules
15735398|NCT04981704|Drug|Paroxetine|Paroxetine Tablets
15735399|NCT04981691|Biological|anti-MESO CAR T cells|Autologous genetically modified anti-MESO CAR T cells
15735400|NCT04981678|Drug|Buprenorphine|Patients randomized to this group will stop their buprenorphine prior to surgery.
15735401|NCT04981678|Drug|Buprenorphine|Patients randomized to this group will continue their buprenorphine at a reduced dose.
15735402|NCT04981665|Drug|Tislelizumab|Tislelizumab 200mg IV Q3W
15735403|NCT04981665|Drug|TACE|TACE will be performed after curative resection (4±1w)
15735404|NCT04981652|Dietary Supplement|Whole Milk|Participants will consume twice daily whole milk beverages in addition to a standardized diet.
15735405|NCT04981652|Dietary Supplement|Skim Milk|Participants will consume twice daily skim milk beverages in addition to a standardized diet.
15735406|NCT04981652|Dietary Supplement|Almond Beverage|Participants will consume twice daily almond beverages in addition to a standardized diet.
15735407|NCT04981639|Procedure|IVPCA|Intravenous patient controlled analgesia will be performed.
15735408|NCT04981639|Procedure|TAP|Transversus abdominis plane block will be performed.
15735409|NCT04981639|Procedure|IMS|Intramuscular electrical stimulation will be performed.
15735410|NCT04981626|Other|Clinical and experimental session|"Psychologic profile with standardized interview and scales (see below for details: SCID, BDI, STAI, BPQ, EDE Q, Pictorial Body Image Scale (PBIS) and EDI).
~Measure the stomach-brain synchrony during EEG/EGG resting state, the distribution of voluntary actions across the respiratory phase, and the distribution of saccadic eye movements across the cardiac-cycle."
15735411|NCT04981613|Drug|Kunxian capsule|Kunxian capsule (2# tid or 2# bid) + irbesartan tablet (150mg qd or 300mg qd) for 48 weeks
15735412|NCT04981600|Device|Radiofrequency ablation|Patients in the RF group will be first examined under anesthesia at the beginning of the procedure in lithotomy position. Approximately 3-6 ml of 20 mg/ml Lidocaine (Jetokaine, Adeka İlaç Sanayi, Samsun) solution will be injected between the cushion and the internal anal sphincter to minimize heat conduction to the surrounding tissues during the procedure. The HPR45i probe (F Care Systems, Antwerpen, Belgium) connected to the Rafaelo ® EVRF machine (F Care Systems, Antwerpen, Belgium) will be placed inside the cushion and 25 watts of RF energy will be transmitted. Care will be taken by not exceeding the dentate line caudally. The recommended Joule value for each operation is 1200-3000 J. Then cold is applied on the cushion, reducing the temperature of the tissue and preventing damage to the surrounding tissues. The same procedure will be performed for other pathologic cushions as well.
15735413|NCT04981600|Device|Laser|"The same preoperative preparations will be done for the laser group as well. The NeoV 1470 (neoLaser, Israel) device will be used in this group. Following routine placement of the patient in lithotomy position and determining the cushion to be treated, a 12 W laser beam with a wavelength of 1470nm will be inserted into the cushion above the dentate line and advanced to the apex and approximately 3 laser shots are delivered throughout the course caudally, the number of which can be altered according to the size targeted cushion. Finally the procedure will be completed after gentle cold application.
~An enema will be given to the patients in both study groups in the morning of the operation and patients will be discharged with analgesics on the same day."
15735904|NCT04977505|Device|gryphon|The surgery procedure was performed with Gryphon for fixation
15735415|NCT04981587|Other|Usual treatment|The usual treatment is based on activities to enhance brain functions: attention, memory, executive functions, language and orientation.
15735418|NCT04981561|Drug|GATE-251|Single dose of GATE-251
15735419|NCT04981561|Drug|Placebo|Placebo
15735420|NCT04981548|Other|no intervention|no intervention
15735421|NCT04981535|Device|Head box during upper gastrointestinal endoscopy|"็Head box is an acrylic box over a patient's head who undergoing upper gastrointestinal endoscopy."
15735422|NCT04981522|Behavioral|Indigenously adapted problem management plus (IA-PM+)|The IA-PM+ manual would be comprised of the following evidence-based techniques: (a) problem solving, (b) stress management, (c) behavioral activation and (d) accessing social support. The IA-PM+ intervention consisting of five sessions, will teach the participants techniques to manage their emotional problems.
15735426|NCT04981483|Procedure|conservative surgery for uterus in placenta accreta|After removal of the placenta, grasping the cervix from the both lips and one from each side of the cervical canal at the level of the internal os, each uterine angle and grasped the remaining lower uterine segment and Nelaton catheter was inserted inside the cervical canal to avoid closing the cervix with sutures of the uterine incision.Closing the uterine incision;taking suture at the lateral angle of the cervix and suturing it to the lower edge of the uterine angle, then another continuous suture was attached to the upper edge of the uterine incision angle[outside in-in out then out in-in out] and the same technique was repeated on the other side (cervico-isthmic sutures). controlling bleeding from the inner surface of the remaining lower uterine segment was done by 2-3 interrupted sutures between the lower uterine segment and the anterior cervical lip. closing of the uterine incision in continuous non-locking manner
15735427|NCT04981470|Device|baroloop System|vagal nerve stimulation
15735428|NCT04981457|Drug|Misoprostol and iso sorbide mononitrates|drug
15735431|NCT04981418|Device|customised pelvic support shorts|"These apply targeted compressive forces to the pelvic girdle through selective precisely positioned reinforced lycra panels that aim to stabilize and align body segments to improve function and reduce unwanted movements. The construction material (Nylon and Elastane) is durable and breathable, and its mechanical properties enable it to provide dynamic stability and support (rather than the rigid support provided by off-the-shelf belts) during movement/functional activities. This aims to optimise comfort and movement to increase wear compliance, which is crucial as any benefits gained rely upon this."
15735432|NCT04981418|Other|Exercise|Women will be provided with up to a maximum of 4 exercises from a pre-defined list of exercises. Suggested dosages are referred to in the protocol. The exercise programme contains a range of exercise focused around the pelvic girdle and hips (including movement control and strengthening
15735433|NCT04981418|Other|advice|standardised advice on management of pelvic girdle pain, through a discussion centred around 'Guidance for Mothers-to-be and New Mothers: Pregnancy-related Pelvic Girdle Pain' booklet (https://pogp.csp.org.uk/system/files/pogp-pgppat_3.pdf). This publicly available, specialist physiotherapy approved, standardised leaflet, provides information reflective of current best practice. The participant can use this as an ongoing resource.
15735434|NCT04981405|Biological|COVID-19 Vaccines|"Gam-COVID-Vac EpiVacCorona COVIVAC"
15735435|NCT04981392|Behavioral|Health System Vaccination Text Messages|"The participating healthcare systems will implement the intervention in a fashion that is consistent with other healthcare system patient reminders. Patients not vaccinated for COVID-19 will be sent a series of text messages including a message from their PCP, information on how and where to schedule a vaccination, and a link to online educational materials that they can access if they choose. Subjects will be given the option to STOP the text messages.
~Providers will be asked to participate in an educational session, during which they will be introduced to the study and presented with underlying research supporting message content, as well as the importance of provider recommendations for vaccination. Providers will also be given the opportunity (separate from participation in the session) to request a modification to text message wording and content, to decline to have text messages sent to their patients, and/or to identify specific patients to not send text messages to."
15735436|NCT04981379|Drug|Hydroxychloroquine|Hydroxychloroquine (200 mg), as two tablets per day for 5-day interval + Placebo [Favipiravir (1600 mg)], as two tablet per day at the first day and then Favipiravir (600 mg) as two tablet per day for the remaining 4-day interval.
15735437|NCT04981379|Drug|Favipiravir|Favipiravir (1600 mg), as two tablet per day at the first day and then Favipiravir (600 mg) as two tablet per day for the remaining 4-day interval + Placebo [Hydroxychloroquine (200 mg)], as two tablets per day for 5-day interval.
15735438|NCT04981379|Drug|Favipiravir + Hydroxychloroquine|Favipiravir (1600 mg), as two tablet per day at the first day and then Favipiravir (600 mg) as two tablet per day for the remaining 4-day interval + Hydroxychloroquine (200 mg), as two tablets per day for 5-day interval.
15735439|NCT04981379|Drug|Placebo|Placebo [Favipiravir (1600 mg)], as two tablet per day at the first day and then Placebo Favipiravir (600 mg) as two tablet per day for the remaining 4-day interval + Hydroxychloroquine (200 mg), as two tablets per day for 5-day interval.
15735440|NCT04981366|Dietary Supplement|Protein supplement|40g of whey protein in the breakfast;
15735441|NCT04981366|Dietary Supplement|isocaloric supplement|42g of isocaloric supplement in the breakfast;
15735442|NCT04981353|Procedure|bilateral erector spinae plane block at T11|A real-time high-frequency linear ultrasound will be used to do the thoracic (ESP) at the level of T11 by visualizing the transverse process of T11 thoracic vertebrae and erector spinae muscle and injecting a 20 ml of bupivacaine 0.25% bilaterally using an in-plane technique, a 20-gauge, 70-mm needle (Tuoren, Henan, China) will be advanced into the plane below (ESM) after injecting lidocaine 1% 2ml at the site of injection, Needle will be advanced with a cranial to caudal directio
15735443|NCT04981340|Behavioral|Diaphragmatic breathing|Same as previously described
15735444|NCT04981340|Behavioral|Standard urotherapy|Same as previously described
15735445|NCT04981327|Drug|Apixaban 2.5 MG Oral Tablet [ELIQUIS]|Apixaban 5 MG BID versus Apixaban 2.5 MG BID
15735446|NCT04981314|Drug|Equinacea Arkopharma|Echinacea hard caplets
15735447|NCT04981314|Other|Placebo|Placebo hard caplets
15735448|NCT04981301|Drug|Quadratus Lumborum Block|The block procedure will be applied after the surgery and before extubation with patients in the prone position by using US (Vivid Q, GE Healthcare, US). Under aseptic conditions using 10% povidone iodine, the convex probe will be covered with a sterile sheath and a 22G, 100 mm block needle (Braun Stimuplex Ultra 360, Germany) will be used. After visualizing the abdominal muscles with the anterior approach, the needle will be punctured in the Petit triangle and 5 ml of saline will be injected into the anterolateral border of the quadratus lumborum muscle. After the block location is confirmed, 15 ml of 0.25% bupivacaine will be injected. The same process will be applied to the opposite side (30 ml totally).
15735449|NCT04981275|Other|No intervention study|This observational study will only collect data, not provide any intervention to participants.
15735450|NCT04981262|Dietary Supplement|Stimulance|Intervention with Prebiotic supplement
15735451|NCT04981236|Procedure|Pericapsular nerve group block|A curvilinear 2-5MHz ultrasound probe will be initially placed in a transverse plane over the anterior superior iliac spine and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the iliopubic eminence, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be observed. A 22-gauge, 80-mm needle will be inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. A total volume of 20 ml of ropivacaine 0.3% will be injected.
15735452|NCT04981236|Procedure|Periarticular block|The periarticular injection solution contained 20mL of 7.5 mg/mL ropivacaine, 30mg of ketorolac, and 0.3mL of 1.0 mg/mL epinephrine. These agents were mixed with normal saline to a combined volume of 50mL. The surgeon injected this mixture into the tensor fascia lata, subcutaneous tissues, abductors, short external rotators muscles, and structures in the capsule.
15735453|NCT04981223|Device|ExactVu|clinical micro-ultrasound, imaging Device, Manufacturer; Exact Imaging
15735454|NCT04981197|Behavioral|Baduanjin exercise|Patients in the intervention group underwent a 12-week Baduanjin exercise programme consisting of 12 weeks of Baduanjin exercise, a 35-min Baduanjin exercise demonstration video, a picture-based educational brochure, and a performance record form.
15735455|NCT04981184|Device|Gait and balance measurement|Virtual gait training procedures are included. Balance training procedures with Biodex Balance system are included too.
15735456|NCT04981171|Procedure|Electro-thumbtack Needle Therapy|Each treatment session starts with sterilizing acupoints. Dazhui (GV14), bilateral Wangu (GB12), bilateral cervical Jiaji (at C4 and C6 level), two Ashi points and bilateral Houxi (SI3) have been selected in accordance with the principle of acupuncture prescription making and the consensus of experts on treating neck pain. Electro-thumbtack needles (0.25×2 mm) will be held by the acupuncturist between thumb and forefinger, vertically inserted into skin instantly and taped well on skin. Then assemble the gel electrodes to the surface of the conductive adhesive tape, also assemble the portable stimulation devices, adjust the current intensity from level 1 to a proper level that the participant can tolerate. Participants will receive three 30-min treatment sessions per week every other day for 4 consecutive weeks.
15735457|NCT04981171|Procedure|Sham electro-thumbtack needle therapy|Each treatment session starts with sterilizing acupoints. Sham electro-thumbtack needles (0.25×0.2 mm) will be held by the acupuncturist between thumb and forefinger, taped well on skin without penetration. The adhesive tape of needles are also produced with conductive material, after assembling the gel electrodes and the portable stimulation devices, adjust the current intensity to level 1 for a minimal stimulus which will last for only 30 seconds. By this time the acupuncturist will turn the device off to cut the current. Participants will receive three 30-min treatment sessions per week every other day for 4 consecutive weeks.
15735458|NCT04981158|Procedure|(Epidural /GA using tolerable endotracheal tube (TET) group, group II|patients will undergo a single shot epidural bupivacaine (15 ml with 0.25% concentration) followed by a standard general anesthetic technique in which the trachea was intubated using TET, through its side port 2mg/kg , lidocaine 2% will be sprayed immediately after intubation when the patient is in flat supine position then the same dose of lidocaine will be repeated 10 minutes before anesthetic discontinuation.
15735459|NCT04981158|Procedure|standard general anesthetic technique, control group, group I|patients will undergo standard general anesthesia with classic endotracheal tube
15735460|NCT04981145|Drug|Iguratimod Tablets|Participants are treated with Iguratimod Tablets 25 mg Twice a day for 24 weeks.
15735461|NCT04981145|Drug|Hydroxychloroquine Sulfate Tablets|Participants are treated with Hydroxychloroquine Sulfate Tablets 200 mg Twice a day for 24 weeks.
15735462|NCT04981132|Behavioral|Pain Neuroscience education|The education group will have a comprehensive patient education which includes; description, transmission, representation of pain, central sensitization, neuroplasticity, its relation to body systems, psychosocial and emotional factors affecting pain, pain behavior, and lifestyle changes to cope with pain, etc.
15735463|NCT04981132|Behavioral|Progressive therapeutic exercise training|The exercise group will have exercise prescription according to participants' assessment and evaluation results. Exercise training will be supervised.
15735467|NCT04981106|Other|Elastic Band Exercise|"The participants were asked to do exercise 4 times a day with a minimum of 2 hours interval between the sessions. The participants were instructed to avoid elastic band exercise 1 hour before or after the meals in order to prevent a physical impairment and to adopt a moderately progressive approach in order to prevent lower extremity pain after exercise and to increase the sense of success and confidence.
~Through phone calls, researchers asked the participants in intervention group if they do the elastic band exercises at home and if they had any difficulty while doing these exercises, as well as the reasons if they haven't done the exercises. When the participants in control and intervention groups returned to hospital after 4 weeks, the knee joint movement, lower extremity strength, knee joint pain, quality of life, kinesiophobia, and depression levels and physical functions of these groups were compared."
15735468|NCT04981093|Drug|Dexamethasone Injection|"Intravenous injection after induction of anesthesia
~Injection 0.15mg/kg dexamethasone (2ml)"
15735469|NCT04981093|Drug|Normal saline|2ml of normal saline was injected intravenously after induction of anesthesia
15735470|NCT04981080|Diagnostic Test|Urodynamic study|The urodynamic assessment, including noninstrumented uroflowmetry, filling cystometry with 35°C distilled water at a rate of 60 mL/sec, a pressure flow study, and urethral pressure profilometry, was performed with the patient in a sitting position according to the recommendations by the International Continence Society.
15735471|NCT04981067|Other|Maintain the concentration of ropivacaine as same as those used in the previous participant|Maintain the same concentration of ropivacaine used in the previous participant with an 89% chance through a random assignment
15735472|NCT04981067|Other|Decrease the ropivacaine concentration by 0.05% from the concentration used in the previous participant|Decrease ropivacaine concentration by 0.05% from the concentration used in the previous participant with an 11% chance through a random assignment
15735473|NCT04981067|Other|Increase the ropivacaine concentration by 0.05% from the concentration used in the previous participant|Increase ropivacaine concentration by 0.05% from the concentration used in the previous participant.
15735474|NCT04981054|Procedure|Cystocele repair|Repair of endopelvic fascia and anterior colporrhaphy
15735475|NCT04981041|Drug|Prasugrel or Ticagrelor|Escalated antiplatelet therapy with a potent P2Y12- inhibitor for one month in patients with atrial fibrillation and indication for treatment non-vitamin K antagonist oral anticoagulants (NOACs)
15735476|NCT04981041|Drug|Clopidogrel|Clopidogrel and NOAC
15735477|NCT04981028|Other|Questionnaires (including PHQ-9, TYM and SF-36)|For the acute group, a questionnaire is completed on neurological symptoms at presentation plus specific questions to include brain imaging performed, treatments received and whether they survived the hospital admission (AQ1). There will be a healthcare practitioner led questionnaire (AQ2) and 3 patient led questionnaires (PHQ-9, TYM and SF-36) plus a supplementary questionnaire (AQ3) completed at 1 week, 1 month, 3 months, 6 months and 12 months following diagnosis. For the chronic TTP group, participants will have a questionnaire completed (CQ1) and 3 patient-led questionnaires (PHQ-9, TYM and SF-36) plus a supplementary questionnaire (CQ2). Where neurological symptoms are present, questionnaires will be completed 6 monthly; where there are no neurological symptoms questionnaires are completed every 12 months. The healthy volunteers will complete participant led questionnaires (namely PHQ-9, TYM, SF-36) plus a supplementary baseline questionnaire at two time points 12 months apart.
15735478|NCT04981015|Diagnostic Test|Three-day bladder diary|A three-day bladder diary for recording voiding-flow pattern of a women
15735479|NCT04981002|Other|Telemedicine Consultation with self orthopedic exam|Brief telemedicine consultation, with self orthopedic exam,blinded to subsequent face-to-face evaluation.
15735480|NCT04981002|Other|Face-to-face Consultation|Direct face-to-face evaluation (without telemedicine consultation before).
15735481|NCT04980989|Device|Mobile software for follow-up of early breast cancer|The patients were randomized to use mobile software or telephone calls as the follow-up modality for early breast cancer
15735482|NCT04980976|Device|Blind insertion technique|Transesophageal echocardiography probe will be inserted using a conventional blind insertion technique.
15735483|NCT04980976|Device|C-MAC videolaryngoscope insertion technique|Transesophageal echocardiography probe will be inserted using a C-MAC videolaryngoscope insertion technique
15735484|NCT04980963|Behavioral|Cognitive Support Technology (CST)|Cognitive Support Technology (CST) products and strategies are used to help people with disabilities compensate for or accommodate cognitive limitations (including those related to interpersonal communication and social cognition) that present difficulties for them in the performance of desired social roles, especially education and employment. CSTs may be mainstream everyday technologies such as tablet computers or they may be specialized devices designed for specific goals such as step-by-step instruction in the performance of a particular task (Scherer, 2012).
15735485|NCT04980950|Dietary Supplement|Impact Oral Nestlé Health Science, Cubitan® Nutricia, Nutridrink® Nutricia, Resource 2.0 Nestlé Health Science|Gastric and colorectal cancer patients will receive 1 bottle of immunonutrition or standard nutrition for 10 days. The aims of this study is to assess the effects of these immunonutrition on gut microbiota, intestinal permeability as well as inflammation of intestines in gastric and colorectal cancer patients.
15735486|NCT04980937|Procedure|Microsurgical reconstruction of peroneal nerve with or w/o nerve grafts.|
15735487|NCT04980924|Other|no intervention|no intervention
15735488|NCT04980898|Device|WoundEL medical device|"The WoundEl system is composed by: a class IIa device , a class IIb dressing electrode and a class I disperser electrode.
~Applied to the leg ulcer, WoundEL® reproduces the endogenous electrical current to stimulate all the factors contributing to healing. Electrical current is evenly spread over the Dressing Electrode which also maintains a moist wound healing environment."
15735489|NCT04980898|Other|Standard cares|Cleaning and monitoring
15735490|NCT04980885|Drug|AK117|Subjects receive AK117 intravenously.
15735491|NCT04980885|Drug|Azacitidine|Subjects receive Azacitidine subcutaneously.
15735673|NCT04979455|Other|Stool collection|Stool samples will be collected at baseline and on the day of exercise
15735493|NCT04980859|Drug|Zebutinib&BR or Zebutinib&FCR|Introduction period: Zebutinib 160 mg bid oral treatment for 3 months;Joint stage :6 sessions of Zebutinib FCR( under 60 years of age,Fludarabine 25 mg/m² Q3W, Cyclophosphamide 250 mg/m² Q3W,Rituximab 375 mg/m² Q3W) or BR (over 60 years of age, )(28 days and 1 cycle);Maintenance treatment: after the end of the combined phase, continue the treatment of zebutinib.
15735494|NCT04980846|Other|Driving under the influence of alcohol with a driving simulator|"Participants will drive in three different states (sober, drunk above and below the legal limit) on designated circuits using a driving simulator. After the initial sober driving session, participants are administered pre-mixed alcoholic beverages (e.g., vodka orange). Participants are expected to achieve a target BrAC of 0.35 mg/l (legal limit in Switzerland is 0.25 mg/l BrAC) before the second driving session starts. Finally, the third driving session starts when the participants' BrAC drops to 0.15 mg/l. Heart rate, skin conductance, accelerometer, eye movement, radar, facial expression, and speech will be recorded by a smart-watch, an eye-tracker, microphones and an onboard camera, respectively.
~Participants will be blinded to their alcohol levels during the study. They will have to rate their symptoms and their performance via questionnaires before and after each driving session. Further, capillary blood and oral fluid samples will be collected."
15735496|NCT04980820|Other|No mask|The participant is asked to wear no mask for 10 minutes.
15735497|NCT04980820|Device|Filtering face mask 2 (FFP2)|The participant is asked to wear a FFP2 mask for 1 hour during work.
15735498|NCT04980820|Device|Filtering face mask 3 (FFP3)|The participant is asked to wear a FFP3 mask for 1 hour during work.
15735499|NCT04980794|Behavioral|Parent-child intervention|Families (two adult caregivers, child between 4 and 17) receive four interactive, asynchronous psychoeducation modules to review on their own paired with weekly contact with a communication coach and two live sessions with a communication coach to discuss psychoeducation, receive feedback on their interactions, and practice a communication technique.
15735500|NCT04980794|Behavioral|Self-study Intervention|Families (two adult caregivers) receive information in a newsletter format to review on their own, paired with weekly contact from a communication coach to answer questions and direct their attention toward specific topics in the newsletter.
15735501|NCT04980781|Behavioral|Physical exercise and dietary therapy (PED-t)|Behavioral therapy: Physical exercise and dietary therapy (PED-t) is a treatment of bulimia nervosa and binge eating disorder, relying on guided, progressive resistance exercise therapy and dietary therapy (dietary education and group discussions) following a designed therapy manual.
15735502|NCT04980781|Procedure|Implementation program for PED-t in ERC|Participating in a training program for therapists in PED-t; to increase knowledge of eating disorders and to be able to implement and run the PED-t. Training program consists of a therapy manual, digital lectures, and 3 work shops.
15735503|NCT04980768|Procedure|Root canal treatment|Patients with apical periodontitis will undergo root canal treatment.
15735504|NCT04980755|Other|Body Reprogramming|An educational intervention originally designed for patients with fibromyalgia.
15735505|NCT04980742|Procedure|acute normovolemic hemodilution|acute normovolemic hemodilution
15735506|NCT04980729|Device|Acetabular reconstruction after tumor resection.|In the template-guided group (n = 10), a navigation template was designed and applied to assist acetabular reconstruction. In the traditional operation group (n = 14), the patients underwent the same surgery but without the navigation template. To compare the displacement of the hip rotation center before and after surgery between the two groups, an innovative method based on pelvic CT was developed and a validation group of cases was used to assess the effectiveness of this measurement approach. In the validation group (n = 12), patients undergoing periacetabular puncture or curettage without hip joint reconstruction were included. The displacements for the validation group were calculated and compared with 0 cm, the theoretical value. Subsequently, the displacements between the template-guided group and the traditional operation group were compared.
15735507|NCT04980716|Drug|"Multiple cardiovascular drugs related to Golden Triangle"|Based on impedance cardiography results at each timepoints, cardiovascular drug treatment and exercise plan will be given in the intervention group.
15735508|NCT04980703|Device|Grain moxibustion|Take Baihui(GV20), apply vaseline on the acupoint, knead moxa villi into grain size, put it on GV20, and ignite it with incense. When the patient feels burning or a little pain, put out moxa with gauze and keep for 10 seconds, so as to ensure enough heat to be penetrated into the acupoint. There are 3 cones for the first six times and 5 cones for the last six times . After the treatment of GV20, the patient will be in prone position. Select bilateral Xinshu(BL15) and Pishu(BL20) and operate the same as that of GV20. 3 times a week, 12 times in all. During the trial, patients with severe sleep disorders will be allowed to take the sedative-hypnotic drug eszopiclone 0.5-2mg orally (Sinopharm approval H31021534, Shanghai Shangyao Xinyi Pharmaceutical Co., Ltd.).
15735509|NCT04980703|Device|Sham grain moxibustion|Take Baihui(GV20), apply vaseline on the acupoint, knead moxa villi into grain size, put it on GV20, and ignite it with incense. When the moxa burns to half （the patient hasn't feel hot or feel a little hot）, take the moxa away with tweezers. There are 3 cones for the first six times and 5 cones for the last six times . After the treatment of GV20, the patient will be in prone position. Select bilateral Xinshu(BL15) and Pishu(BL20) and operate the same as that of GV20. 3 times a week, 12 times in all. During the trial, patients with severe sleep disorders will be allowed to take the sedative-hypnotic drug eszopiclone 0.5-2mg orally (Sinopharm approval H31021534, Shanghai Shangyao Xinyi Pharmaceutical Co., Ltd.).
15735510|NCT04980703|Other|Standard care|Participants in the wait-list control with severe sleep disorders will be allowed to take the sedative-hypnotic drug eszopiclone 0.5-2mg orally (Sinopharm approval H31021534, Shanghai Shangyao Xinyi Pharmaceutical Co., Ltd.). And after waiting for 12 weeks, these patients will be treated with the same grain moxibustion as the grain moxibustion group.
15735511|NCT04980690|Biological|IBC0966|IBC0966 is an investigational product.
15735592|NCT04980118|Behavioral|Nutrition and physical activity group|A nutritional and physical activity intervention program that consisted of two individual nutritional consults and five nutritional group lectures.
15735593|NCT04980105|Biological|Platelet-rich plasma|Two intra-articular injections of autologous platelets-rich plasma (PRP) in two weeks intervals between the first and the second injection.
15736492|NCT04972513|Procedure|Nitric Oxide Breath Test|Undergo nitric oxide breath testing
15735512|NCT04980677|Device|Tangiball|"To enable baseline scores comparison, children will be matched according to age and score on the four-strand Hands-On assessment tool which takes 30 minutes to complete. Children will then play with the Smart Toy during a 20 minute session. Sessions will be recorded using an SD card within the Smart Toy which captures information on user speed and accuracy of placement of the detachable segments of the toy when placed into the main hub of the toy, allowing comparison between neuro-typical children and children with Autism. The intervention will run either in clinic (preferred option) or in children's homes-and in this case will be sent to them via post with the Standard Operating Procedure which can then be employed when children are taking part in the intervention via online video link (not recorded)."
15735513|NCT04980664|Other|Integrated intervention strategies|Implementation of integrated intervention strategies to reduce the proportion of indicated-but-not-treated CHB patients.
15735514|NCT04980651|Procedure|Remote ischemic conditioning|Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg.
15735515|NCT04980651|Procedure|Sham remote ischemic conditioning|Sham remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg.
15735516|NCT04980638|Biological|ER004|Intra-amniotic route 100 mg/kg of estimated fetal weight per injection. 3 injections, approximately 3 weeks apart starting from gestational week 26
15735517|NCT04980625|Procedure|Remote ischemic conditioning|Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mm Hg.
15735518|NCT04980625|Procedure|Sham remote ischemic conditioning|Sham remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 60 mm Hg.
15735519|NCT04980612|Behavioral|Mindfulness Based Pain Reduction|40 participants will participate in a MBPR program. It will be an optimized mindfulness program specifically designed for treating cLBP that we will develop and test in this project. The format is the same as MBSR: 8 weeks of weekly 2½-hour group sessions and a daylong retreat.
15735520|NCT04980612|Behavioral|Mindfulness Based Stress Reduction|10 participants will participate in MBSR program. MBSR is a standardized and manualized 8-week program, delivered once a week in 2½-hour group sessions and a daylong retreat. It trains individuals in several mindfulness practices, e.g. focus on breath, varying degrees and directions of object orientation, open monitoring of awareness of intero- and exteroceptive stimuli and thoughts, de-reification (i.e. the notion that thoughts and perceptions are not always true to reality), and meta-awareness (i.e., awareness of thinking) in addition to focused attention.The program typically includes audio-recordings and a workbook for home practice and has shown benefits in patients with cLBP.
15735521|NCT04980599|Dietary Supplement|probiotic drink with Lactobacillus paracasei K56|Probiotic drink (K56 10^11CFU) 350ml/d for 60days
15735522|NCT04980599|Dietary Supplement|maltodextrin powder|maltodextrin powder 3g/d ,for 60days
15735523|NCT04980599|Dietary Supplement|Probiotic powder E3|Probiotic powder 3.0g/d (K56 10^10cfu) 60days;
15735524|NCT04980599|Dietary Supplement|Probiotic powder E5|probiotic powder 8g/day for 60days
15735525|NCT04980599|Dietary Supplement|probiotic capsule E7|probiotic k56 capsule, 2capsules/d (10^7cfu) for 60days
15735526|NCT04980599|Dietary Supplement|probiotic capsule E9|probiotic k56 capsule, 2capsules/d (10^9cfu) for 60days
15735527|NCT04980599|Dietary Supplement|probiotic capsule E10|probiotic k56 capsule, 2capsules/d (10^10cfu) for 60days
15735528|NCT04980599|Dietary Supplement|probiotic capsule E11|probiotic k56 capsule, 4capsules/d (10^11cfu) for 60days
15735529|NCT04980586|Diagnostic Test|CASA score protocol to Non-obstructive sleep apnea Group|CASA score observe the cheeks appearance: volume of the cheeks (0, 1, 2 or 3) and flaccidity, (0, 1, 2 or 3). The final score is volume + flaccidity score to have the CASA score (0-6). A photography was captured to enable the blinded evaluation of three evaluators of each participant. Ultrasonography was positioned in the face of the participant and slide to capture the muscle image (masseter muscle, buccinator and the tongue). Tongue and cheeks pressure were assessed with a device with a small bulb. Inside the mouth in the tongue, the participant is instructed to press the bulb against the hard palate. In the cheeks, the bulb is placed between the cheek and the teeth and the participant press the bulb with the cheek. Swallowing evaluation with an endoscope that enters in the nose of the participant to observe the the oropharynx; while the participant is eating liquid consistency, pureed consistency and solid food.
15735530|NCT04980586|Diagnostic Test|CASA score protocol to Mild obstructive sleep apnea Group|CASA score observe the cheeks appearance: volume of the cheeks (0, 1, 2 or 3) and flaccidity, (0, 1, 2 or 3). The final score is volume + flaccidity score to have the CASA score (0-6). A photography was captured to enable the blinded evaluation of three evaluators of each participant. Ultrasonography was positioned in the face of the participant and slide to capture the muscle image (masseter muscle, buccinator and the tongue). Tongue and cheeks pressure were assessed with a device with a small bulb. Inside the mouth in the tongue, the participant is instructed to press the bulb against the hard palate. In the cheeks, the bulb is placed between the cheek and the teeth and the participant press the bulb with the cheek. Swallowing evaluation with an endoscope that enters in the nose of the participant to observe the the oropharynx; while the participant is eating liquid consistency, pureed consistency and solid food.
15735531|NCT04980586|Diagnostic Test|CASA score protocol to Moderate obstructive sleep apnea Group|CASA score observe the cheeks appearance: volume of the cheeks (0, 1, 2 or 3) and flaccidity, (0, 1, 2 or 3). The final score is volume + flaccidity score to have the CASA score (0-6). A photography was captured to enable the blinded evaluation of three evaluators of each participant. Ultrasonography was positioned in the face of the participant and slide to capture the muscle image (masseter muscle, buccinator and the tongue). Tongue and cheeks pressure were assessed with a device with a small bulb. Inside the mouth in the tongue, the participant is instructed to press the bulb against the hard palate. In the cheeks, the bulb is placed between the cheek and the teeth and the participant press the bulb with the cheek. Swallowing evaluation with an endoscope that enters in the nose of the participant to observe the the oropharynx; while the participant is eating liquid consistency, pureed consistency and solid food.
15735532|NCT04980586|Diagnostic Test|CASA score protocol to Severe obstructive sleep apnea Group|CASA score observe the cheeks appearance: volume of the cheeks (0, 1, 2 or 3) and flaccidity, (0, 1, 2 or 3). The final score is volume + flaccidity score to have the CASA score (0-6). A photography was captured to enable the blinded evaluation of three evaluators of each participant. Ultrasonography was positioned in the face of the participant and slide to capture the muscle image (masseter muscle, buccinator and the tongue). Tongue and cheeks pressure were assessed with a device with a small bulb. Inside the mouth in the tongue, the participant is instructed to press the bulb against the hard palate. In the cheeks, the bulb is placed between the cheek and the teeth and the participant press the bulb with the cheek. Swallowing evaluation with an endoscope that enters in the nose of the participant to observe the the oropharynx; while the participant is eating liquid consistency, pureed consistency and solid food.
15735533|NCT04980573|Other|Aromatherapy|The aromatherapy intervention consists of inhaling a fragrant oil extracted from citrus peels, plant resins, and leaves.
15735534|NCT04980573|Other|Placebo|The placebo intervention consists of inhaling an oil extracted from inert plant matter.
15735535|NCT04980547|Device|ACUMED® Scapholunate Repair System Group|To address the technical difficulties associated with the RASL procedure, Dr. Mel Rosenwasser developed an external over-the-top jig that in theory enables accurate and easy scapholunate-axis screw placement. The Acumed Scapholunate Repair System was designed treat patients with acute or chronic, static or dynamic scapholunate instability in the absence of significant capitolunate osteoarthritis, scapholunate ligament repair, scapholunate reduction, lunotriquetral ligament repair, lunotriquetral reduction, and carpal instability. This new Scapholunate Repair System features a targeting guide designed to enable the surgeon to reproducibly place the implant in optimal position. The implant allows physiologic intercarpal scapholunate rotation by means of a free rotation design. The procedure can forestall progressive osteoarthritis and the need for secondary salvage procedures.
15735538|NCT04980521|Other|The radon app|Participants will be asked to use the radon app.
15735539|NCT04980521|Other|Print brochure|Participants will receive print brochures.
15735540|NCT04980508|Diagnostic Test|corpus cavernosum electromyography|Cc-EMG was performed by using the cc-EMG module of Ellipse 4 device (Andromeda, Germany), which comprises of a 2-channel electromyography amplifier with a row sampling rate of 16 kHz, filtered sampling rate of 166.67 Hz and a band width of 0.5-30 Hz with the speed of the thermo-writer paper set at 5 mm/s. Measurements of the electrical activity of the corpus cavernosum (EACC) were done for 10 minutes using coaxial needle electrodes during the flaccid state and after intracavernous papaverine (60 mg) injection.
15735541|NCT04980495|Biological|Efgartigimod concentrate for solution for infusion 20 mg/mL|Patients receiving efgartigimod IV treatment in a continuous treatment regimen
15735542|NCT04980495|Biological|Efgartigimod concentrate for solution for infusion 20 mg/mL|Patients receiving efgartigimod IV treatment in a cyclic treatment regimen
15735543|NCT04980482|Drug|AB-729|subcutaneous injection
15735544|NCT04980482|Drug|Peg-IFNα-2a|subcutaneous injection
15735545|NCT04980469|Other|Vitex negundo + Zingiber officinale|200 mg/ Capsule
15735546|NCT04980469|Other|Placebo (MCC)|200 mg/ Capsule
15735547|NCT04980456|Device|Lehfilcon A contact lenses|Investigational silicone hydrogel contact lenses
15735548|NCT04980456|Device|Comfilcon A contact lenses|Commercially available silicone hydrogel contact lenses
15735549|NCT04980456|Device|CLEAR CARE|Hydrogen peroxide-based cleaning and disinfecting solution
15735550|NCT04980443|Diagnostic Test|CELTiC test|The CELTiC test is a blood-based test consisting of four mRNA markers and the risk factor age.
15735551|NCT04980430|Device|Virtual Reality|Virtual Reality Demonstration
15735552|NCT04980417|Procedure|concomitant cholecystectomy|delayed cholecystectomy
15735553|NCT04980404|Drug|Inqovi|Tablet combination of drugs decitabine and cedazuridine, given orally.
15735554|NCT04980391|Biological|RSV MAT|Single dose of the RSV MAT vaccine reconstituted with NaCl solution, administered intramuscularly in the non-dominant arm, at Day 1.
15735555|NCT04980391|Drug|Placebo|Single dose of placebo, administered intramuscularly in the non-dominant arm, at Day 1.
15735556|NCT04980378|Device|Simplify Disc|The Simplify Disc is a cervical artificial disc manufactured from polyether ether ketone (PEEK) endplates and a mobile, zirconia-toughened alumina ceramic core.
15735557|NCT04980365|Behavioral|Mindfulness|Participants will be asked to use the app Mindfulness Coach daily for 10 minutes. Participants will follow app instructions for brief guided meditation sessions for 14 days.
15735558|NCT04980365|Behavioral|Gratitude|Participants will be asked to use the app Grateful daily for 10 minutes. Participants will follow app instructions and will be answering to prompts related to gratitude provided by the app daily, for 10 minutes for 14 days.
15735559|NCT04980365|Behavioral|Food Journal|Participants will be asked to use the app Day One daily for 10 minutes. Participants will be writing a daily journal entry describing what they ate during the previous day for 14 days.
15735560|NCT04980352|Other|real world treatment by doctors|real world treatment by doctors
15735561|NCT04980326|Behavioral|Doing What Matters (DWM)|The original DWM program consists of a self-help guide called 'Doing What Matters in Times of Stress', that is complemented with pre-recorded audio exercises. The audio material imparts key information about stress management and guides participants through individual exercises. Additionally, participants are guided by a briefly trained helper. In this study, DWM will be delivered as an online intervention. The DWM intervention, i.e. both the audio recordings and the self-help guide, will be adapted for use on a smartphone or other device with internet access during Phase 1 of RESPOND. The format of DWM is innovative in that it seeks to ensure that key intervention components are delivered as intended through the use of pre-recorded audio, without the burden of extensive training and supervision. In the online application tool a new module is released every week so participants will be asked to go through the entire DWM intervention within 5 weeks with weekly guidance from a helper.
15735594|NCT04980105|Drug|Hyaluronic acid|Two intraarticular injections of hyaluronic acid (60 mg) in two weeks intervals between the first and the second injection
15735562|NCT04980326|Behavioral|Problem Management Plus (PM+)|PM+ is a new, brief, psychological intervention program based on cognitive behavioral therapy (CBT) techniques. The manual involves the following empirically supported elements: problem solving plus stress management, behavioral activation, facing fears, and accessing social support. Across the five 90-minute sessions participants may talk to trained non-professional. PM+ has four core features, and it is brief. In this study, the delivery mode of the PM+ intervention will be flexible, with remote delivery in phases of the pandemic when physical distancing rules apply. This is a future-oriented attempt towards a more holistic mental health care system that can flexibly switch between modes of delivery (e.g. remotely (e.g. Zoom) or face-to), depending on the needs and the specific containment measures that apply, and the specific preferences and needs of the participant.
15735563|NCT04980326|Behavioral|Psychological First Aid (PFA)|PFA is a brief intervention consisting of providing basic information for peer support in times of emotional distress
15735564|NCT04980313|Device|Xenogenic collagen matrix|Use of xenogenic collagen matrix for the maintenance of buccal soft tissues around immediate dental implantes into extraction sockets.
15735565|NCT04980313|Device|Autogenous connective tissue graft|Use of connective tissue graft for the maintenance of buccal soft tissues around immediate dental implantes into extraction sockets.
15735566|NCT04980300|Behavioral|Expanded Intervention|Participants in the Expanded Intervention arm will receive five virtual consultation sessions, delivered by a physical therapist over 12 weeks (at Weeks 1, 2, 4, 7, and 10) and lasting approximately 45-60 minutes each. Each session will focus on lower extremity strengthening exercises, physical activity (i.e., walking), and education about knee osteoarthritis. Participants will be provided with an exercise manual, tracking log, educational manual, and a step counter. Participants will be prescribed up to 6 exercises (quadriceps, hip abductor/gluteal, hamstrings/gluteal, calf, balance) and daily walking step goals. Progression will be a joint decision by the participant and physical therapist. Education will include information on knee osteoarthritis, managing pain, being active, weight loss, dealing with setbacks, and progressing activity. The physical therapist will also discuss barriers and facilitators to meeting and progressing goals as appropriate.
15735567|NCT04980300|Behavioral|Brief Intervention|Participants in the Brief Intervention arm will receive access to a study-specific website that navigates them to a variety of web-based resources on knee osteoarthritis. Topics for the various resources include an overview of knee osteoarthritis, brief anatomy of the knee and how that is related to pain, different types of arthritis pain and how to manage it, and how to be active with arthritis. Sessions range from 20 - 70+ minutes.
15735568|NCT04980274|Other|Intervention focused on identified organ dysfunction(s)|Intervention focused on identified organ dysfunction(s)
15735569|NCT04980261|Procedure|ORIF + autograft|Patients will undergo a standard open reduction internal fixation (ORIF) procedure with autograft implantation (from the iliac crest).
15735570|NCT04980261|Procedure|ORIF + FD BHA/Secretome|Patients will undergo an ORIF procedure and subsequently receive freeze-dried bovine hydroxyapatite/secretome composite implantation.
15735571|NCT04980248|Biological|ALXN1850|ALXN1850 will be administered as an IV infusion and via the SC route.
15735572|NCT04980235|Diagnostic Test|transperineal 3D ultrasound|All ultrasound volumes were acquired 7days after delivery and another examination 6weeks post-delivery by one experienced sonographers using a GEVoluson p8 (GE Healthcare) equipped with a 4-8-MHz curved array 3Dultrasound transducer
15735580|NCT04980209|Device|ultrasound evaluation|According to the sequential test, the enrolled patients were divided into ultrasound evaluation group and no ultrasound evaluation group.
15735581|NCT04980196|Diagnostic Test|urodynaemic studies|The Urodynamic studies carried out were : uroflowmetry and cystometry. The Uroflowmetry was performed by the gravimetric method Detrusor over activity was diagnosed when the patient has involuntary detrusor contractions during filling with or without leakage which may be spontaneous or provoked,
15735582|NCT04980183|Device|Arthroscopic surgical robot|The surgeon performs cruciate ligament bone canal positioning and ligament reconstruction with the assistance of an arthroscopic surgical robot
15735583|NCT04980183|Device|Conventional arthroscopic cruciate ligament reconstruction|The surgeon performs conventional arthroscopic cruciate ligament reconstruction surgery without other auxiliary equipment
15735584|NCT04980170|Drug|Clindamycin 300 mg|patients will be given clindamycin 300 mg twice daily for 5 days after dental implant
15735585|NCT04980170|Drug|Amoxicillin with Clavulanic Acid 635mg|patients will be given Amoxicillin with Clavulanic Acid 635mg, three times daily for 5 days after dental implant
15735587|NCT04980144|Drug|3% Diquafosol tetrasodium|3% Diquafosol tetrasodium eye drops will be used to assess its usefulness in diabetic dry eye symptoms
15735588|NCT04980144|Drug|0.1% hyaluronate|0.1% hyaluronate eye drops will be used to assess its usefulness in diabetic dry eye symptoms and compared to 3% Diquafosol tetrasodium eye drops.
15735589|NCT04980131|Device|Pointed lotus root regulator and guide template aided PPSF|20 patients in group C received PPSF with pointed lotus-style regulator
15735590|NCT04980131|Device|Flat ended lotus root regulator and guide template aided PPSF|20 patients in group B received PPSF with flat ended lotus-style regulator
15735591|NCT04980118|Behavioral|Control group|A nutritional intervention program that consisted of two individual nutritional consults.
15735595|NCT04980105|Drug|Methylprednisolone acetate injectable suspension (DEPO-MEDROL®)|Single methylprednisolone acetate intraarticular injection (DEPO-MEDROL® pfizer 80 mg) mixed with 3cc of (xylocaine 2% concentration)
15735596|NCT04980092|Other|one-year follow-up|patients will be followed during the year after ICU discharge, in order to assess kidney function, and muscle and bone health
15735597|NCT04980079|Procedure|Primary ureterscopy URS|Ureteral dilatation will be done when the stone size exceeds 10 mm to facilitate the extraction of the fragments. Ureteroscopic lithotripsy will be done using a 6.5:7.5 Fr semi-rigid ureteroscope and holmium laser. The ureteric stent will last for one week after lithotripsy
15735598|NCT04980079|Procedure|deferred ureteroscopy URS|insertion of a double -J stent or percutaneous nephrostomy (PCN) at first , then a deferred ureteroscopy URS will be done .
15735599|NCT04980066|Procedure|Sticky bone and EDTA|treatment using Sticky bone after EDTA root surface biomodification
15735600|NCT04980066|Procedure|Sticky bone|treatment using Sticky bone
15735601|NCT04980053|Other|massage|Intervention group Control group
15735602|NCT04980040|Drug|Alogliptin Benzoate|Alogliptin benzoate tablets
15735603|NCT04980027|Drug|Insulin glargine (U300)|Pharmaceutical form:Solution for injection in a prefilled pen Route of administration: Subcutaneous
15735604|NCT04980014|Drug|NesinaAct® Tablet|NesinaAct® tablet is a fixed dose combination (FDC) of alogliptin benzoate with pioglitazone HCl.
15735605|NCT04980001|Behavioral|Families OverComing Under Stress Trauma Informed Care in Childhood Obesity among Minorities (FOCUS TIC-COM)|FOCUS TIC-COM is a program that helps doctors coach families to recognize how emotions or feelings about various life stressors may affect a child's dietary choices and physical activity. FOCUS TIC-COM is for families of children who have been identified by their doctor as overweight or obese. The goal of the program is to help children and their families understand how their mental health may impact their physical health and develop strategies to address their mental health needs.
15735606|NCT04979988|Drug|Lortlatinib|as provided in real world practice
15735607|NCT04979975|Other|Placebo|PBO- placebo matching to UB-621
15735608|NCT04979975|Biological|UB-621 low-dose|fully human anti-HSV mAb
15735609|NCT04979975|Biological|UB-621 high-dose|fully human anti-HSV mAb
15735610|NCT04979962|Device|EW10-EC02 (Endoscopy Support Program)|EW10-EC02 is intended to automatically detect the location of suspected polyps in colonoscopy exams. Identified polyps are highlighted to the clinician in real-time during the exam, as a video image superimposed on the endoscope monitor. EW10-EC02 is limited to the detection of suspected findings, and should not be used in lieu of full patient evaluation or relied upon to make or confirm a diagnosis.
15735613|NCT04979936|Procedure|laparoscopic cholecystectomy|
15735614|NCT04979936|Procedure|percutaneous cholecystostomy|
15735615|NCT04979923|Drug|Lidocaine|Lidocaine will be used for nebulization of the covid-19 patients and will be compared with other two drugs
15735616|NCT04979910|Drug|Ixekizumab|a monoclonal antibody (mAb) against interleukin 17A (IL-17A)
15735617|NCT04979910|Drug|Placebo|matching placebo
15735618|NCT04979897|Other|Intensive care unit stay during the COVID-19 pandemic|Patients will be screened daily for a potential ICU discharge. Each site coordinator, which is a clinician physiotherapist responsible for the site, will check that the patient is delirium-free (CAM-ICU negative) and cooperative (i.e. using 5 standardised questions: open [close] your eyes; look at me; open your mouth and stick out your tongue; nod your head; raise your eyebrows when I have counted up to five) within 72 hours from ICU discharge. Every patient deemed eligible will be invited to participate through a face-to-face visit by the assigned evaluator, receiving verbal and written information about the study
15735619|NCT04979884|Drug|cyclosporine|Dose of Cyclosporine oral capsule of 6 mg/kg/day divided into two doses with normal kidney function for 8-14 days
15735620|NCT04979871|Procedure|Venous bleeding|Blood samples collected 5 times with approx. 2-4 weeks interval
15735621|NCT04979858|Device|Focal Mask|The treatment group will receive and use the focal mask.
15735622|NCT04979845|Other|Telerehabilitation|Patients will receive telerehabilitation sessions for 12 weeks including aerobic and strengthening exercises
15735623|NCT04979845|Other|Video exercise|Patients will receive video instructions for home based exercises
15735624|NCT04979832|Drug|GM-CSF, fosfomycin and metronidazole|GM-CSF 50 micrograms Fosfomycin 400 milligrams Metronidazole 100 milligrams applied as a gel in the pouch
15735625|NCT04979819|Other|Upper extremity endurance test (UULEX)|Patients will lift 5 bars consecutively rhythmically until they feel fatigued. The bars will weigh 200 grs 500 gr 1kgs and 2 kgs respectively. The duration of the test will be measured to determine the endurance levels of the patients.
15735626|NCT04979806|Drug|Cefepime-zidebactam (FEP-ZID)|3 g (2 g FEP + 1 g ZID) IV q8h
15735627|NCT04979806|Drug|Meropenem|1 g IV q8h
15735628|NCT04979793|Drug|L-citrulline|3 gram sachet, L-citrulline
15735629|NCT04979793|Drug|Placebo|Milk powder placebo
15735630|NCT04979780|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Retrospective cohort analysis using US Optum De-Identified EHR data.
15735631|NCT04979780|Drug|Low molecular weight heparin (LMWH)|Retrospective cohort analysis using US Optum De-Identified EHR data. LMWH (dalteparin, enoxaparin, tinzaparin)
15735632|NCT04979780|Drug|Direct Oral Anticoagulants (DOAC)|Retrospective cohort analysis using US Optum De-Identified EHR data. DOAC (apixaban, dabigatran, edoxaban, rivaroxaban).
15735633|NCT04979754|Other|standard of care|retrospective study : standard of care
15735634|NCT04979741|Other|No interventions|Observational study, no intervention is required
15735635|NCT04979728|Other|Fingerstick collection of dried blood spots|Directly observed self-collection of dried blood spots via fingerstick at home
15735636|NCT04979715|Procedure|physitherapy follow-up|Physiotherapy meeting will be held every 2 weeks for 3 months
15735637|NCT04979715|Other|control|no intervention
15735638|NCT04979702|Behavioral|Active Control|Participants will complete a 3-month exercise and physical activity intervention supported by online recourses
15735639|NCT04979702|Behavioral|mHealth technology assisted exercise counselling|Participants will complete a 3-month exercise and physical activity intervention supported by online recourses, exercise counselling sessions and mHealth technology
15735640|NCT04979689|Other|Intensive physical therapy|Intensive physical therapy treatment protocol was given for 3 months 3 times a week including 1.5- 2-hour session. Pre and post treatment assessments were taken. It included stretching for 20 min, Proprioception on ball for 20 minutes, quadruped for 10 min, vibration therapy for 20 min, tapping twice a month for 5 days, sensory therapy with beans for 20 min, supine lying with hand below head for 10-15 min, texturing for 15 min and activity of making tower with cups and hitting in outward direction for 15-20 min.
15735641|NCT04979689|Other|Non intensive physical therapy|Non intensive therapy included 45 min session 3 times a week for 3 months. Pre and post treatment assessments were taken. The protocol included stretching for 20 min, cross friction massage for 15 min, Ball catch and throw for 15 min. progression was made from light to heavy weight ball.
15735642|NCT04979676|Behavioral|Cognitive Therapy|Experimental psychotherapy based on the cognitive model for social anxiety disorder, applied individually and remotely to participants fulfilling inclusion criteria.
15735643|NCT04979676|Behavioral|Compassion-focused Therapy|Experimental psychotherapy based on the principles of the compassion-focused model, applied individually and remotely to participants fulfilling inclusion criteria.
15735644|NCT04979676|Behavioral|Acceptance and Commitment Therapy|Experimental psychotherapy based on the principles of the acceptance and commitment model, applied individually and remotely to participants fulfilling inclusion criteria.
15735645|NCT04979663|Combination Product|Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab|Combination of Gemcitabine, Oxaliplatin, Donafenib and Tislelizumab every 3 weeks
15735646|NCT04979650|Drug|Methylprednisolone succinate|1 gram of methylprednisolone succinate within 500 ccs of normal saline
15735647|NCT04979650|Drug|Normal saline|500 g of normal saline without methylprednisolone succinate
15735648|NCT04979611|Drug|68Ga-NOTA-exendin-4|A single dose of 37-111 Mega-Becquerel (MBq) 68Ga-NOTA-exendin-4 will be injected intravenously
15735649|NCT04979598|Other|Home exercise program|A home exercise program is provided but this is an observational study. The effect of the exercise program is not under investigation.
15735650|NCT04979585|Drug|Camrelizumab|200mg ,IV,d1,Q3W.
15735651|NCT04979585|Drug|Anlotinib|8mg,oral, d1-14,Q3W.
15735652|NCT04979585|Drug|nab-Paclitaxel|260mg/m2,IV,d1,Q3W.
15735653|NCT04979572|Drug|TS-172|"Single doses of TS-172 10 mg, 30 mg, 90 mg, 270 mg before breakfast in each period (only 30 mg administered before breakfast and fasting)
~Multiple dose of TS-172 90 mg before breakfast and dinner"
15735654|NCT04979572|Drug|Placebo|"Single doses of TS-172 placebo before breakfast in each period (only placebo administered before breakfast and fasting in step 2)
~Multiple dose of TS-172 placebo before breakfast and dinner"
15735655|NCT04979559|Device|Mobile health apps|Mobile health application intervention including screening and early intervention such as diet and physical activity suggestion
15735656|NCT04979559|Other|Standard care|Regular practice for screening and early intervention for prediabetes patient in primary health cares setting
15735657|NCT04979546|Other|Intensive Use of Patient Reported Outcome Measures and Open PROM Availability to Treating Neurologist|"Baseline, 6 months, and 12 months administration of HADS, EQ5D, MFIS, PDDS, PHQ-9 questionnaires in addition to Open ended text response to (limit 280 characters) What are the top 3 things you would like your MS Neurologist to know about you right now?
~Additionally, the treating neurologist will be prompted to view the text response to the 3-item prompt in addition to the PROM questionnaire scores for participants in the interventional group."
15735658|NCT04979546|Other|Conservative Use of Patient Reported Outcome Measures and Blinded PROM Availability to Treating Neurologist|"Baseline and 12 months administration of HADS, EQ5D, MFIS, PDDS, PHQ-9 questionnaires in addition to Open ended text response to (limit 280 characters) What are the top 3 things you would like your MS Neurologist to know about you right now?
~Additionally, the treating neurologist will only be prompted to view the text response to the 3-item prompt, and will not be able to access the PROM questionnaire scores for participants in the control group."
15735659|NCT04979533|Device|Insufflator oxygen tubing|high flow, low pressure oxygen with pressure relief valve and luer Lock connections delivered at 15 L/min through surgeon's laryngoscope.
15735660|NCT04979520|Drug|Brodalumab|Subcutaneously Brodalumab/Siliq, 210mg/1.5ml once a week
15735661|NCT04979507|Other|Uninterrupted sleep followed by functional neuroimaging.|2 within-subject sleep conditions: uninterrupted sleep; selective REM sleep reduction, followed by functional neuroimaging with emotion reactivity and regulation tasks the following morning
15735662|NCT04979481|Behavioral|BRAVE|The BRAVE campaign included 3-5 text messages per week for 8 weeks, including 1 role model video per week and a related image. The role model videos (1-3 minutes each) featured relatable characters experiencing and addressing violent behavior, alcohol misuse, and suicidality (through the eyes of a perpetrator, an intimate partner violence survivor, and a peer bystander), intended to demonstrated important coping and help-seeking skills.
15735663|NCT04979481|Behavioral|STEM|The STEM campaign included 3-5 text messages per week for 8 weeks, including 1 role model video per week and a related image. The series promoted STEM career pathways and highlighted Native professionals in Science, Technology, Engineering, Math, and Medical careers.
15735664|NCT04979468|Drug|DOVATO|Dovato is a medicine for treating infection with human immunodeficiency virus type 1 (HIV-1), a virus that causes acquired immune deficiency syndrome (AIDS).
15735665|NCT04979455|Other|Core temperature monitoring|Core temperature will be monitored on the day of exercise
15735666|NCT04979455|Behavioral|Questionnaires|Questionnaires will be completed at baseline and on the day of exercise
15735667|NCT04979455|Other|Heart rate monitoring|Heart rate will be monitored on the day of exercise
15735668|NCT04979455|Other|Urine collection|Urine samples will be collected at baseline and on the day of exercise
15735669|NCT04979455|Other|Sleep monitoring|Sleep will be monitored at baseline and on the day of exercise
15735670|NCT04979455|Other|Blood collection|Blood samples will be completed at baseline
15735671|NCT04979455|Other|Saliva collection|Saliva samples will be collected at baseline and on the day of exercise
15735672|NCT04979455|Other|Throat swab collection|Throat swab samples will be collected at baseline and on the day of exercise
15735676|NCT04979429|Behavioral|Perioperative Pain Self-management (PePS)|4 sessions of telephone CBT-based pain self-management.
15735677|NCT04979416|Behavioral|Video messages|video messages aimed at increasing vaccination
15735678|NCT04979403|Other|Physiotherapy|Participants from each group will receive 8 intervention sessions (45 min) over 11 weeks by a physiotherapist. For both groups, each intervention will be tailored to the patient's profile and the choice of interventions and parameters will be at the judgment of the physiotherapist.
15735679|NCT04979390|Drug|SHR-1316|SHR-1316 administrated intravenously (IV) at protocol defined dose levels
15735680|NCT04979377|Other|Clinical hyperandrogenism assessment|Modified Ferriman-Gallwey scale
15735681|NCT04979377|Diagnostic Test|Total testosterone (ng/dL)|Circulating total testosterone (LC-MS/MS or IQL-CDC method) at follicular phase
15735682|NCT04979377|Diagnostic Test|A1c (%)|High Performance Liquid Chromatography (HPLC)
15735683|NCT04979377|Diagnostic Test|Total cholesterol|Determined by enzymatic methods
15735684|NCT04979377|Other|Body mass index (BMI) (kg/m2)|Defined as body weight divided by the square of body height, and expressed in kg/m2
15735685|NCT04979377|Diagnostic Test|Frequency of chronic vascular complications [n (%)]|Retinopathy, nephropathy, neuropathy, and macrovascular disease.
15735686|NCT04979377|Diagnostic Test|Polycystic ovary morphology|Sonographic assessment
15735687|NCT04979377|Diagnostic Test|Cardiovascular autonomic reflex tests (CARTs)|Cardioautonomic function assessement by Vital scan HW7-HW6T:
15735688|NCT04979377|Diagnostic Test|Sex hormone-binding globulin (SHBG) (nmol/L)|Circulating SHBG (IQL) at follicular phase
15735689|NCT04979377|Diagnostic Test|Dehydroepiandrosterone-sulphate (IQL) (ng/mL)|Circulating DHEAS (IQL) at follicular phase
15735690|NCT04979377|Other|Waist circumference (cm)|Waist circumference measurement made at the top of the iliac crest
15735691|NCT04979377|Other|Waist-to-hip ratio|Waist circumference divided by hip circumference (measurement should be taken around the widest portion of the buttocks)
15735692|NCT04979377|Other|Body composition|Vital Scan HW7-HW6T
15735693|NCT04979377|Diagnostic Test|Mean glucose (mg/dL)|Continuous glucose monitoring (GCM) records
15735694|NCT04979377|Diagnostic Test|Time in target range (hours)|Continuous glucose monitoring (GCM) records
15735695|NCT04979377|Diagnostic Test|Time in hyperglycemia (hours)|Continuous glucose monitoring (GCM) records
15735696|NCT04979377|Other|Insulin dose (UI/Kg)|Daily insulin dose divided by body weight
15735697|NCT04979377|Other|Insulin sensitivity|Equation that relies on routine clinical measures: A1c, presence of hypertension, and waist circumference
15735698|NCT04979377|Diagnostic Test|High-density lipoprotein (HDL) (mg/dL)|Enzymatic methods after precipitation of serum with phosphotungstic acid and Mg2+
15735699|NCT04979377|Diagnostic Test|Low-density lipoprotein (LDL) (mg/dL)|Estimated by the Friedewald's equation.
15735700|NCT04979377|Diagnostic Test|Triglycerides (mg/dL)|Determined by enzymatic methods
15735701|NCT04979351|Other|Abdominal Massage|Abdominal massage will be applied twice a day.
15735702|NCT04979338|Other|Ultrasound guided Continuous Infraclavicular Brachial Plexus Block|20cc of 0.25% bupivacaine + 1:200K epinephrine will be administered at start of case, 20cc of 0.25% bupivacaine + 1:200K epinephrine at end of case, and 6cc/hr of 0.25% bupivacaine at post-op [administered by anesthesiologist]
15735703|NCT04979338|Other|Ultrasound guided Continuous Femoral Nerve Block|20cc of 0.25% bupivacaine + 1:200K epinephrine will be administered at start of case, 20cc of 0.25% bupivacaine + 1:200K epinephrine at end of case, and 6cc/hr of 0.25% bupivacaine at post-op [administered by anesthesiologist]
15735704|NCT04979338|Other|Ultrasound guided Pudendal Nerve Block|20-40cc of 0.25% bupivacaine + 1:200K epinephrine [administered by anesthesiologist, pre-incision]
15735705|NCT04979338|Drug|Bupivacaine|0.25% or 0.5% with or without 1:200K epinephrine
15735706|NCT04979338|Other|Bilateral ultrasound guided Transversus Abdominis Plane Block|40-60cc of 0.25% bupivacaine + 1:200K epinephrine [administered by anesthesiologist post-op or at end of surgery]
15735707|NCT04979338|Other|Bilateral spermatic cord block|10cc per spermatic cord of 0.5% bupivacaine [administered by surgeon @ intraop]
15735708|NCT04979338|Other|Pecs I & II Block|0.25% bupivacaine: 15-30mL per side for Pecs I-III
15735709|NCT04979338|Other|Local anesthetic|0.25% or 0.5% bupivacaine into the appropriate surgical site
15735711|NCT04979299|Other|Wheelchair|Patient will be asked to sit in a wheelchair, and a 5-minute video recording of spontaneous speech capturing the semi-structured iCGI interview is made.
15735712|NCT04979286|Other|Kinesiotaping|"Y strip kinesiotaping will be applied to both the gastrocnemius muscles while keeping the participant's ankle in full dorsiflexion. The tape will start from the plantar surface of the toe and continue proximally. The medial Y tail will be applied along the medial border of the gastrocnemius and the lateral Y tail along the lateral border of the gastrocnemius, at approximately 20% tension from the resting length. End points will end just below the popliteal crease."
15735713|NCT04979286|Other|Placebo Kinesiotaping|Placebo kinesiotaping, approximately 5x5 cm in size, will be applied to the body of both gastrocnemius muscles without any tension.
15735714|NCT04979273|Drug|Dextrose 40 % in Water|injection of adrenaline 1:20.000, followed by dextrose 40% spray
15735715|NCT04979273|Drug|Adrenaline 1 Mg/mL Solution for Injection|injection of adrenaline 1:20.000, followed by thermocoagulation or hemoclip
15735716|NCT04979273|Procedure|argon plasma coagulation|Thermocoagulation
15735717|NCT04979273|Procedure|Hemoclip|Hemoclip
15735718|NCT04979247|Drug|Oliceridine|Near the end of surgery, patients will be given ≤1.5 mg of oliceridine as a bolus. Postoperatively, patient-controlled analgesia (PCA) will be started with no background infusion, demand doses of 0.35 mg, with a 6 minute lock-out. Additional boluses (≤1 mg) of oliceridine will be given as deemed necessary (based on NRS score and clinical assessment of the patient) as soon as 15 minutes after the initial 1.5 mg loading dose. In addition to supplemental 1 mg bolus doses, the PCA demand dose can be increased to a maximum of 0.5 mg oliceridine.
15735719|NCT04979234|Device|Endomina- Endoscopic Sleeve Gastroplasty|Endoscopic gastric reduction
15735720|NCT04979234|Behavioral|Diet|Multidisciplinary follow up
15735721|NCT04979221|Drug|Cyproheptadine|Cyproheptadine 8mg three times a day during 10 days
15735722|NCT04979195|Other|Patients with stable normal kidney function|Covid-19 patients with stable kidney function will represent group 1.
15735723|NCT04979195|Other|Patients with unstable kidney function|Covid-19 patients with unstable kidney function will represent group 2.
15735724|NCT04979169|Behavioral|Text Messaging|A series of theory-informed text messages encouraging them to contact their primary care provider and the UR LCS Program's Patient Navigator to coordinate screening, along with contact information to do so.
15735725|NCT04979156|Procedure|SOLTIVE™ Thulium Laser Fiber En Bloc Resection of Bladder Tumors|SOLTIVE™ Thulium Laser Fiber En Bloc Resection of Bladder Tumors
15735726|NCT04979143|Procedure|Surgical Approach|The surgical laser used will be randomized. All lasers used during this trial are all FDA approved devices and used per routine clinical care.
15735727|NCT04979130|Drug|Semaglutide|Semaglutide 1.34 mg/mL solution for injection in 1.5 mL pre-filled PDS290 pen-injector provided by Novo Nordisk.
15735728|NCT04979130|Drug|Placebo|Semaglutide placebo, solution for injection, 1.5 mL pre-filled PDS290 pen-injector provided by Novo Nordisk.
15735729|NCT04979117|Device|Superb Microvascular Imaging (SMI) (Toshiba)|to determine whether there is a diagnostic value of SMI in Plantar Fasciitis and whether there is a superiority when compared Power Doppler and Color Doppler modalities.
15735730|NCT04979104|Procedure|Hip arthroplasty with SL Cementless|Total or partial hip arthroplasty with implant of SL cementless femoral stem.
15735731|NCT04979091|Diagnostic Test|Sex Hormones|A panel of 13 hormones was measured in plasma samples of COVID-19 patients (total testosterone, free testosterone, dihydrotestosterone, androstenedione, 17-β-estradiol, estrone, sex hormone-binding globulin, thyroid-stimulating hormone, free triiodothyronine (T3), free thyroxine (T4), luteinizing hormone, follicle-stimulating hormone and cortisol).
15735732|NCT04979078|Device|Photobiomodulation therapy (PBMT)|Patients will receive PBM on the sole of their feet and palms of their hands
15735733|NCT04979065|Dietary Supplement|Probiotics, Vitamin D|Combination of two supplement that given separately
15735734|NCT04979065|Other|Placebo|Placebo with inactive ingredient
15735735|NCT04979052|Drug|Interferon Gamma-1B|100 microgram per day, three times a week, subcutaneous. The duration of the treatment is twelve days or until hospital discharge.
15735736|NCT04979039|Other|analgesia nociception index (ANI) monitoring|The ANI monitor starts lying on the bed in the waiting area before entering the operating room, and the monitoring period should be at least 15 minutes. After entering the operating room, monitoring begins again and is maintained during the operation.
15735737|NCT04979026|Device|active ankle pumping with a regular watch alarm|In addition to the active ankle pumping exercise for the operative limb, the patients were reminded to exercise at specific time points with a vocal alarm and vibration through a wrist watch during the hospitalization period and at home after discharge.
15735738|NCT04979026|Device|intermittent pneumatic compression|In this group, intermittent pneumatic compression was applied to the operative low limb during hospitalization, while active ankle pumping exercise was adopted without any reminder after discharge.
15735739|NCT04979013|Other|Smoking Abstinence|Smokers will be switched to smoking abstinence for 14 days
15735740|NCT04978974|Behavioral|Stress Management Program|Stress management program includes different techniques such as relaxation technique, psycho-education, laughing, emotional freedom technique, referenting, cognitive restructuring, rational emotive imagery, time management, anger management, assertiveness and social support
15735741|NCT04978961|Behavioral|Focused Acceptance & Commitment Therapy (FACT)|FACT is a brief form of Acceptance and Commitment Therapy and in this study, FACT focused on increasing patient functioning through connection with valued activities and increased acceptance.
15735742|NCT04978961|Behavioral|Enhanced Treatment as Usual (ETAU)|This active control intervention included 4 handouts focused on pain management based on cognitive behavioral science.
15735743|NCT04978935|Other|Care protocol|"Before starting the application, the investigator (DS) will fill out the Introductory Characteristics Form of all patients, the Pre-thoracotomy Pulmonary Function Test (PFT) section of the Patient Results Form. The PFT section will be re-evaluated on the 1st, 5th day and on the day of discharge after thoracotomy.
~Nursing interventions will be applied to the study group (n=40), starting from the 0th day (the first day spent in the intensive care unit) after the thoracotomy in line with the prepared care protocol application steps until discharge. Care protocol consists of patient's position, mobilization, use of spirometer and shoulder exercises."
15735744|NCT04978922|Device|Machine Learning: ML (Artificial Intelligence System)|To applicate an artificial intelligence system (Machine Learning: ML) on an active telemonitoring programme of readmitted COPD patients (TelEPOC)
15735745|NCT04978896|Device|Self-guided program on stress coping|This is an 8-day program that provides psychoeducation on the negative effects of stress and effective stress-management skills to combat stress. Guided by principles of CBT, the program targets the thoughts and behaviours of participants and equips them with skills to alter negative cognitions pertaining to stress. Participants are engaging with a series of exercises involving reflection and mindfulness where they are required to spot and write down their stressors, the negative thoughts associated with the stressors, as well as positive affirmations. Participants will also be taught breathing exercises and are encouraged to practice them during 2 check-ins.
15735746|NCT04978896|Device|Self-guided program on cooperation|The 8-day program on cooperation aims to provide psychoeducation for participants to understand and improve collaboration and interpersonal relationships. Short quizzes and practice exercises on feedback-giving will be included. The time and duration of the cooperation SGA is matched to the stress-coping SGA to ensure that participants spend a similar amount of time and effort across both the intervention and active-control conditions.
15735747|NCT04978883|Other|No intervention|No intervention
15735748|NCT04978857|Other|autobiographic movie|viewing an autobiographic film through a virtual reality headset
15735749|NCT04978844|Behavioral|IWOTCH|Arm 1
15735750|NCT04978844|Behavioral|Dyadic therapy|Arm 2
15735779|NCT04978597|Drug|Placebo|Capsule of to matching placebo, Oral. Swallow whole with water, once daily at bedtime at least 1 hour after L-DOPA/DDCI
15735780|NCT04978584|Drug|Acalabrutinib|Given PO
15735781|NCT04978584|Drug|Cyclophosphamide|Given IV
15735782|NCT04978584|Drug|Doxorubicin Hydrochloride|Given IV
15735783|NCT04978584|Drug|Lenalidomide|Given PO
15735784|NCT04978584|Drug|Prednisone|Given PO
15735751|NCT04978831|Device|PEP Device|The breathing exercise device is a device that simulates pursed lip breathing by creating positive expiratory pressure (PEP). Before starting to use the device, it will be explained that they need to put the mouthpiece on the device and put the nose clip on their nose, and the participants will be shown how it is done. The device will be used at 5 cmH2O pressure. A single exercise session consists of 3 exercise cycles, and a single exercise cycle will consist of 15 inhale-exhale activities. The blood pressure, heart rate and saturation values of the participants will be monitored with the smart watch.
15735752|NCT04978831|Other|Reading Aloud|Participants will be asked to read the given books aloud for 15 minutes, three times a day, sitting upright on a chair or armchair. Participants will read aloud as in the instructions given to them. The blood pressure, heart rate and saturation values of the participants will be monitored with the smart watch.
15735753|NCT04978818|Drug|Vaxelis|Eligible infants will be block randomized to one of two study arms.
15735754|NCT04978818|Drug|PedvaxHIB|Eligible infants will be block randomized to one of two study arms.
15735755|NCT04978805|Behavioral|Progressive Relaxation Exercise|In the progressive relaxation technique, the tension and anxiety in skeletal muscles are relatively relieved.
15735756|NCT04978792|Behavioral|Online self-compassion intervention|An online self-guided intervention that uses widely available exercises and information.
15735757|NCT04978792|Behavioral|Active Control|Participants will complete written exercises and breathing exercises that are not associated with self-compassion
15735758|NCT04978779|Drug|VIP152|Weekly IV infusion (30 minute) for 21 day cycles.
15735759|NCT04978766|Behavioral|Interactive Book Reading|"The intervention is a package including five children's books and information on how to practice interactive book reading. Information includes 36 audiovisual products delivered via text messaging over a 12-week period. Products include:
~An introductory video about interactive book reading, along with a written list of recommendations on how to practice interactive book reading.
~Two videos of child development experts explaining the benefits of interactive reading.
~Thirty written text messages strengthening content provided in the videos.
~Three audio messages guiding the progress of the intervention.
~Based on Abraham and Michie's (2008) taxonomy of behavior change techniques, one audiovisual product prompts specific goal settings, 13 provide instruction, one provides information on consequences, 10 prompt practice, three use follow-up prompts, one prompts self-monitoring of behavior, one models or demonstrates the behavior and six prompt barrier identification."
15735760|NCT04978753|Drug|Anlotinib|"Anlotinib: 12mg/time (BSA≥1.6 m2) or 10mg/time (BSA<1.6 m2), once a day orally, taking two weeks and stopping for one week;
~Almonertinib: 110mg, orally once a day;"
15735761|NCT04978740|Other|Ophthalmological examination|"Eye examination :
~Ocular tonometry to determine intraocular pressure Refraction assessment Retina examination Slit lamp examination Visual acuity Schirmer's test Corneal topography Funduscopic examination Optical coherence tomography"
15735762|NCT04978727|Biological|SurVaxM for patients with relapsed or progressive MB, HGG or ependymoma ages ≥10 and ≤21 years|500 mcg (1 mL) SurVaxM emulsion with Montanide ISA 51. Sargramostim dose is 3.33 mcg/kg/dose for patients < 30 kg, and 100 mcg for patients ≥ 30 kg.
15735763|NCT04978727|Biological|SurVaxM for patients with relapsed or progressive MB, HGG or ependymoma ages ≥1 and <10 years|500 mcg (1 mL) SurVaxM emulsion with Montanide ISA 51. Sargramostim dose is 3.33 mcg/kg/dose for patients < 30 kg, and 100 mcg for patients ≥ 30 kg.
15735764|NCT04978727|Biological|SurVaxM for patients with non-relapsed DIPG post radiation-therapy ages ≥1 and ≤21 years|500 mcg (1 mL) SurVaxM emulsion with Montanide ISA 51. Sargramostim dose is 3.33 mcg/kg/dose for patients < 30 kg, and 100 mcg for patients ≥ 30 kg.
15735765|NCT04978714|Procedure|Cystocele repair|Fascial repair for endopelvic fascia and anterior colporrhaphy
15735766|NCT04978688|Drug|Relugolix|Administered as an oral tablet once daily.
15735767|NCT04978688|Drug|E2/NETA|Administered as an oral tablet once daily.
15735768|NCT04978675|Drug|Fluorine F 18 rhPSMA-7.3|Given IV
15735769|NCT04978675|Procedure|Magnetic Resonance Imaging|Undergo PET/MRI
15735770|NCT04978675|Procedure|Positron Emission Tomography|Undergo PET/MRI
15735771|NCT04978649|Drug|Allisartan Isoproxil|Allisartan Isoproxil 240mg daily will be used to lower BP to below 120 mm Hg systolic.
15735772|NCT04978649|Drug|Amlodipine|Amlodipine 5mg daily will be added to Allisartan Isoproxil and afterwards increased to 10mg daily, if necessary to reach the blood pressure goal (below 120 mm Hg systolic).
15735773|NCT04978636|Other|Continuous low-tidal volume ventilation with using FiO2 of 0.21|The continuous low-tidal volume ventilation with using FiO2 of 0.21 will be defined as the tidal volume of 3 mL/kg IBW (up to maximum 200 mL), 0.21 of FiO2, respiratory rate of 5 per minute, and PEEP 5 cm H20). A recruitment maneuver with 30 cm H2O for 10 seconds will be performed before starting the selected ventilation mode in all patients.
15735774|NCT04978636|Other|Continuous low tidal volume ventilation with using FiO2 of 1.0|The continuous low-tidal volume ventilation with using FiO2 of 1.0 will be defined as the tidal volume of 3 mL/kg IBW (up to maximum 200 mL), 1.0 of FiO2, respiratory rate of 5 per minute, and PEEP 5 cm H20). A recruitment maneuver with 30 cm H2O for 10 seconds will be performed before starting the selected ventilation mode in all patients.
15735775|NCT04978636|Other|Apnea During CPB|There will be no ventilation used
15735776|NCT04978623|Other|high frequency ultrasound|high frequency ultrasound in subgroups of patients with CIDP, anti-MAG, NMMBC and L-S syndrome
15735777|NCT04978610|Behavioral|Virtual Acceptance Commitment Therapy|"For a period of 6 continuous weeks, participants will meet weekly in a virtual group ACT session with a licensed psychologist hosted on a secure, HIPAA compliant, Zoom account. Each session is 1.5 hours will focus on one ACT concept including Acceptance, Values, Mindfulness, Cognitive Defusion, Experiential Avoidance, and Willingness and Committed Action. Subjects will be given the opportunity to share their thoughts as well as their responses to the exercises at various points throughout the sessions.
~At the beginning of each session, each participant will be required to fill out a short survey on their stress and pain the preceding week. Participants in the control group will not complete weekly measures. All measures will be completed online via a REDCap survey web link. Follow up measures will mirror initial baseline measures in order to measure the within group and between group changes in study outcomes."
15735778|NCT04978597|Drug|Opicapone 50 mg|Capsule, 50 mg, Oral. Swallow whole with water, once daily at bedtime at least 1 hour after L-DOPA/DDCI
15735785|NCT04978584|Biological|Rituximab|Given IV
15735786|NCT04978584|Biological|Tafasitamab|Given IV
15735788|NCT04978571|Device|percutaneous electrical nerve-field stimulation, PENFS|A novel, FDA approved for commercial use, cleared device that delivers field stimulation with alternating frequencies to the external ear
15735789|NCT04978571|Device|percutaneous electrical nerve-field stimulation, PENFS (sham device)|A novel, FDA approved for commercial use, cleared device that delivers field stimulation with alternating frequencies to the external ear. The sham device will not deliver field stimulation to the ear.
15735790|NCT04978558|Other|Continuous assessment of cerebrovascular autoregulation with NIRS and TCD|Continuous monitoring of MAP, cerebral oxygenation, and cerebral blood flow velocity before, during, and after surgery to calculate two cerebrovascular autoregulation indices Cox and Mx.
15735791|NCT04978545|Other|calciumhydroxide, intracanal medicament|In the CH group, calcium hydroxide powder (Calxyl; OCO Products, Dirnstein, Germany) was mixed with saline in a ratio 1:1 and the paste was inserted into the canal by using lentulo spirals (Malleifer-Dentsply).
15735792|NCT04978545|Other|chlorhexidine, intracanal medicament|, chlorhexidine gel 2% (Gluco-Chex 2% gel, Cerkamed, Stalowa Wola, Polland) was placed into the root canals of this group with an Ultradent Capillary Tip (Ultradent products).
15735793|NCT04978532|Other|Guided Imagery|The children in the guided imagery group listened to a voice recording named 'Stroll in the Forest' before and during venipuncture. One minute before venipuncture, children wore an earphone and voice recording started. Children closed their eyes, imagined the text content, and focused on the voice recording while listening to the voice. It is a voice recording that helps the children in the guided imagery group to imagine that they are strolling in a forest and guides them.
15735794|NCT04978532|Other|Control Group|No intervention was made in the children.
15735795|NCT04978519|Procedure|Cryotherapy|Cryotherapy is administered by using perineal needles, placed under ultrasound guidance to freeze the target tissue.
15735796|NCT04978506|Drug|BI 1569912|BI 1569912
15735797|NCT04978506|Drug|Placebo|Placebo
15735798|NCT04978493|Drug|BI 706321|BI 706321
15735799|NCT04978493|Drug|ustekinumab|ustekinumab
15735800|NCT04978493|Drug|Placebo|Placebo
15735802|NCT04978467|Device|Exoskeleton|Participants will receive assistance to move finger joints away from the compensatory coordination (compensation avoidance), toward the desired trajectories (task assistance), both, and none in different days.
15735805|NCT04978428|Drug|Cannabidiol|Epidiolex oral solution (2.5 mg/kg and 5 mg/kg)
15735806|NCT04978415|Procedure|peribulbar block versus subtenon's block|"Sixty patients undergoing vitreoretinal surgery were randomized to receive either peribulbar or sub-Tenon's capsule injection of 8 ml of a 20:80 mixture of 2% lidocaine and 0.75% bupivacaine with 60 IU hyalouronic acid.
~two groups 30 patient each (group p and group s) after connecting the patient to the monitor, we give him sedation 50 mg propofol, apply a nasal cannula group P: receives 2 injection peribulbar block group S: receives single injection subtenon Patients rate their pain sensation in both groups using an 11-point (0-10) numerical visual analogue scale immediately after surgery."
15735807|NCT04978376|Behavioral|Time restricted eating|We will compare the effects of time restricted eating alone and combined with resistance exercise of endurance exercise versus a no intervention control group.
15735808|NCT04978363|Device|BOOT|A walking boot is a common type of brace/boot that restricts ankle and foot movement.
15735809|NCT04978363|Device|HFC|The Hands Free Crutch (HFC) by iWalkFree, Inc. is a novel, ambulatory assistive device that prevents foot and ankle loading while also allowing free use of the arms and hands.
15735810|NCT04978363|Device|SAC|Standard axillary crutches (SAC) are ambulatory assistive devices, commonly used for lower extremity injuries or surgeries.
15735811|NCT04978363|Device|HFC+BOOT|The Hands Free Crutch (HFC) by iWalkFree, Inc. is a novel, ambulatory assistive device that prevents foot and ankle loading while also allowing free use of the arms and hands. A walking boot is a common type of brace/boot that restricts ankle and foot movement.
15735812|NCT04978363|Device|SAC+BOOT|Standard axillary crutches (SAC) are ambulatory assistive devices, commonly used for lower extremity injuries or surgeries. A walking boot is a common type of brace/boot that restricts ankle and foot movement.
15735813|NCT04978350|Behavioral|Educational Workbook|"Let's Talk is an educational workbook on Lynch Syndrome and the benefits of cascade screening containing a series of lessons and activities on the following topics:
~What is Lynch Syndrome? Why should a patient tell a patient's family members about Lynch Syndrome? Create a list of the patient's first-degree relatives at risk for inheriting Lynch Syndrome What should a patient tell family members about Lynch Syndrome? Create a script for the patient to use in discussing Lynch Syndrome with family What are common concerns the patient might hear from family members? How should the patient tell family members about Lynch Syndrome? Create a plan and goals for the patient to reach out to family members What the patient should do if conversation with family is difficult What are common terms and questions about Lynch Syndrome? How can the patient manage having Lynch Syndrome? Where can the patient find additional information about living with Lynch Syndrome?"
15735814|NCT04978337|Drug|Rilematovir|Rilematovir 250 mg will be administered orally.
15735815|NCT04978337|Drug|Placebo|Placebo matching to rilematovir will be administered orally.
15735816|NCT04978324|Biological|leukocyte platelet rich fibrin (L-PRF)|Participants blood will be spun to obtain L-PRF strips and liquid L-PRF. Pockets will receive insertion of small L-PRF strips followed by liquid L-PRF injections to fill the 5-8mm pockets of the test side.
15735817|NCT04978324|Procedure|Scaling and Root Planing|Scaling and root planing, which is the standard of care, will be performed on the control side using Cavitron and hand scalers on test and control sides under local anesthesia.
15735865|NCT04977882|Procedure|abdominal drainage|19 Fr abdominal drainage placed intraoperatively in right colic gutter
15735866|NCT04977882|Drug|Postoperative antibiotico-prophylaxis|Ceftriaxone 2 gr and Metronidazole 1.5 gr per day for 2 days postoperatively
15735818|NCT04978311|Behavioral|Mirror therapy (MT) priming with task-specific training|In the regimen, participants will perform MT first followed by task-specific training. After completion of MT, participants will practice task-specific training that emphasizes on restoration of essential skills for daily activities. After that, the contents of home practice will be designed corresponding to treatment principles of the clinic-based intervention.
15735819|NCT04978311|Behavioral|Mirror therapy priming with impairment-oriented training|In the regimen, participants will perform MT first followed by impairment-oriented training. After completion of MT, participants will practice impairment-oriented training that emphasizes on restoration of movement. After that, the contents of home practice will be designed corresponding to treatment principles of the clinic-based intervention.
15735820|NCT04978311|Behavioral|Control therapy|The control group will receive therapeutic training equivalent in duration to the two experimental groups. The control intervention will include practice of gross/fine motor activities, training of activities of daily living, practice to increase range of motions, muscle strengthening, as well as use of adaptive or compensatory technique to alleviate functional deficits. After that, the contents of home practice will be designed corresponding to treatment principles of the clinic-based intervention.
15735825|NCT04978285|Other|Anemia|Depends on Day 3 Hb result
15735826|NCT04978272|Drug|Dihydroartemisinin-piperaquine (DP)|Duo-Cotecxin 20mg/160mg tabs by Holley-Cotec, Beijing, China Each treatment with DP will consist of half-strength tablets given once a day for 3 consecutive days according to weight-based guidelines.
15735827|NCT04978272|Other|DP Placebo|Placebos will be identical appearance to DP.
15735828|NCT04978259|Drug|Remdesivir|Intravenous remdesivir during hospital stay up to 10 days in addition to standard care.
15735829|NCT04978246|Behavioral|Neuropsychometric Test|Participants' global cognitive skills were measured by the Montreal Cognitive Assessment Test (MoCA), the Clock Drawing Test and memory functions, the Öktem Verbal Memory Processes Test (Ö-SBST), the attention functions by the Digit Span Forward and Digit Span Backwards Test, the executive functions by Categorical Fluency, Phonemic Fluency, the Stroop Test, Trail Making Test A and B, visuospatial skills were evaluated with the Rey-Osterrieth Complex Figure Test (ROCF), and behavioral symptoms were evaluated with the Neuropsychiatric Inventory (NPI).
15735830|NCT04978233|Other|sociodemographic and health, daily self-assessment, and feasibility of using the Opal app for COVID|The intervention consists of having confirmed COVID-19 infected participants register for the Opal app and complete a daily questionnaire on symptoms related to their physical and mental health as well as on certain key vital signs (e.g., oxygen saturation, heart rate, temperature). A nurse will check the questionnaire results each day and determine the need for a teleconsultation with an infectious disease physician. Participants will be followed up for a minimum of 14 days, depending on their symptoms.
15735831|NCT04978207|Behavioral|A Faithful Response to COVID-19|See previous description
15735832|NCT04978194|Other|University-based intervention to promote better management of emotions and learning|It included 9 video capsules (that take place over 9 weeks), with the following themes: stress information, learning information, emotion and stress regulation strategies, cognitive and metacognitive learning strategies, motivation for learning, physical activity, diet, sleep, and managing worry and uncertainty. It is based on previous online student mental health intervention studies. It presents two innovative aspects: elements and examples specific to the COVID-19 pandemic and the addition of modules focused on learning strategies. The different modules were designed by 5 associate professors, 2 Master students in clinical psychology and 2 undergraduate students in psychology. For the control group, the videos will be posted every week on a You Tube channel and broadcast on a private discord group. For the hybrid group, student will have to attend 10 lessons of 2 hours. These courses include the viewing of videos and a time for discussion between students and the teacher.
15735833|NCT04978181|Drug|Alteplase Injection|thrombolytic therapy for acute ischemic stroke in time window
15735834|NCT04978168|Behavioral|Core Intervention|Staff are provided with a core set of implementation strategies to facilitate interorganizational linkages between probation agencies and local community treatment providers.
15735835|NCT04978168|Behavioral|Peer Support Specialists (PSS)|Participants randomized to PSS will meet with a PSS for 12 months. Contact scheduled is flexible and based on the participant's needs and wants, plus written guidance for PSS-participant interactions.
15735836|NCT04978168|Behavioral|Treatment as Usual (TAU)|Participants randomized to TAU will receive the services that will be offered at the time the Core Implementation intervention is completed.
15735837|NCT04978155|Diagnostic Test|Duplex ultrasound performed by the surgeon after locoregional anesthesia|Just after locoregional anesthesia, the surgeon perform a duplex ultrasound to determinate if the target vessel chosen to create the arterio-venous fistulae match with the pre-operative duplex performed during the consultation. So the plan can be changed such as more distal, more proximal creation, changing vein or artery target.
15735838|NCT04978142|Device|transcranial Direct Current Stimulation (tDCS)|Non-invasive neuromodulation employing a direct current, applied using a DC STIMULATOR PLUS manufactured by NeuroConn Technology by NeuroCare. This is a micro-processor-controlled constant current source. It meets the highest safety standards thanks to (hardware- and software-based) multistage monitoring of the current path. By continuously monitoring electrode impedance it can detect insufficient contact with the skin and automatically terminate stimulation. This is a reliable method of avoiding any injury to the patient.
15735839|NCT04978129|Behavioral|Online and Text Messaging Intervention|The online and TM intervention, and its delivery, will be designed and adapted based on the results of the formative focus groups and cognitive interviews and is meant to be non-confrontational in tone, seeks to increase motivation to increase the quality use of PBS and decrease motivations for non-use of PBS.
15735867|NCT04977869|Procedure|Remote ischemic conditioning|Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg.
15735868|NCT04977869|Procedure|Sham remote ischemic conditioning|Sham remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg.
15736493|NCT04972513|Procedure|Oscillometry|Undergo airwave oscillometry
15735840|NCT04978116|Diagnostic Test|Chest X-Ray (CXR)|"The 3 following imagings will be performed in the emergency room: chest X-Ray (CXR), low-dose CT scan (LDCT) and lung ultrasonography (LUS) will be performed for all included patients, but only one will be available to the clinician in charge of the patient according to the allocation arm.
~The blinding will be maintained during the first 5 days, and hence will not influence the diagnosis and the treatment of the patient.
~The clinician in charge will be asked to assess on a 3-level Likert scale the probability of pneumonia (high, intermediate, low level) while considering all available clinical and biological data, plus the imaging modality according to the randomization arm."
15735841|NCT04978116|Diagnostic Test|Low-dose CT scan (LDCT)|See above in CXR paragraph
15735842|NCT04978116|Diagnostic Test|Lung ultrasonography (LUS)|See above in CXR paragraph. LUS will be performed by another clinician than the one in charge of the patient
15735843|NCT04978103|Drug|Gum Arabic|A dietary supplement (Powdered exudates of Acacia Senegal (Gum Arabic E-414))
15735844|NCT04978090|Device|3D printed EAF management device|Participants will receive a customized 3D printed device based on the EAF's output, size, shape, location, depth, and the participant's wound bed.
15735845|NCT04978077|Other|Test meal (high fat = Nutricia Calogen®, or high carbohydrate = Nutricia preOp®)|After a night fast participants will drink the test meal
15735847|NCT04978051|Drug|Firazyr|Icatibant 10 MG/ML Prefilled Syringe
15735848|NCT04978051|Other|SoC|The SoC could include respiratory support measures, fluid therapy, antipyretic treatment, postural measures, low-molecular-weight-heparins, corticosteroids, such as dexamethasone, remdesivir and other therapeutic options
15735849|NCT04978038|Drug|MRNA-1273|Moderna COVID-19 Vaccine (mRNA-1273) .5ml dose administered intramuscularly
15735850|NCT04978038|Drug|Prevnar13|Pfizer Prevnar-13 pneumococcal vaccine .5ml dose administered intramuscularly
15735851|NCT04978025|Drug|Colloidal Silver|"Orally: colloidal silver 1 dose of 30ml, 3 times a day for 5 days (use a plastic measuring cup and not a measuring cup or a metal spoon)
~and By inhalation: nebulization of 5ml of colloidal silver solution once, 3 times a day for 5 days."
15735852|NCT04978025|Drug|Placebo|Orally: EPPI 1 dose of 30 ml, 3 times a day for 5 days By inhalation: nebulization of 5ml of EPPI solution once a day, 3 times a day for 5 days.
15735853|NCT04978012|Drug|Fluzoparib and Camrelizumab|Maintenance therapy of Fluzoparib and Camrelizumab, until disease progression or intolerable adverse effect.
15735854|NCT04977999|Other|Exercise|Both arms/conditions use varying forms of exercise as the intervention.
15735857|NCT04977973|Behavioral|Self-guided programme on body image|"Participants will download the application from the App store or Google Play store for free. In both programs, participants engage in content learning and short activities daily on the phone application. The anticipated time participants will spend on each program is comparable, of about less than five minutes per day.
~Participants complete the same set of questionnaires immediately after completing the program (post-intervention measure), and again at 4 weeks after completing the program (follow-up measure).
~At the end of the six weeks data collection period, all participants will be debriefed about the purpose of the study. Participants in the active wait-list control condition will be given access to the body image program."
15735858|NCT04977973|Behavioral|Self-guided programme on cooperation|"Participants will download the application from the App store or Google Play store for free. In both programs, participants engage in content learning and short activities daily on the phone application. The anticipated time participants will spend on each program is comparable, of about less than five minutes per day.
~Participants complete the same set of questionnaires immediately after completing the program (post-intervention measure), and again at 4 weeks after completing the program (follow-up measure).
~At the end of the six weeks data collection period, all participants will be debriefed about the purpose of the study. Participants in the active wait-list control condition will be given access to the body image program."
15735859|NCT04977960|Drug|Potassium Canrenoate|potassium canrenoate for 7 days in addition to maximal medical treatment
15735860|NCT04977947|Behavioral|Healthy Eating for My Infant|The intervention targets problem solving to overcome barriers, behavioral rehearsal and practice of healthy behaviors, promoting readiness to change, goal setting, self-monitoring, and behavioral tracking. Two standard treatment modules will be provided to each family by a study interventionist focusing on infant nutritional requirements, responsive feeding, and mealtime behaviors. Two additional treatment modules will be selected to address the unique needs articulated by each family (e.g., food insecurity, eating healthy on a limited income, emotional eating, engaging other caregivers, maternal mental health). Modules will consider the influence of maternal trauma history and mental health on feeding and eating behavior. The intervention also includes two peer counselor-led sessions during which families can discuss implementation of recommendations and barriers to change with a member of their community who can problem solve and support change.
15735861|NCT04977921|Other|lab session|assign students to clinical modules for study the clinical lab scope of practice
15735862|NCT04977908|Device|CamAPS HX|Fully automated closed-loop system (CamAPS HX) with ultra-rapid Lispro insulin
15735863|NCT04977908|Device|Standard insulin pump therapy with CGM|Participants usual insulin pump therapy with Dexcom G6 CGM
15735864|NCT04977895|Diagnostic Test|Minimal residual disease (MRD) monitoring|Minimal residual disease (MRD) assay using IgH-V(D)J NGS and FCM
15735869|NCT04977856|Behavioral|Behavioral activation (BA)|The main goal of the BA is to increase engagement in values-based activities and decrease avoidant behaviors that serve to maintain depression. The adolescent will learn about depression, how behavioral activations works, monitor their own activities, plan and do more values-based activities and deal with obstacles to getting in touch with positive reinforcement, such as avoidance behaviors.
15735870|NCT04977856|Other|Regular care within primary or secondary mental health care for children|Regular care (supportive therapy, waitlist, psychological treatments, drugs, or a combination of different interventions)
15735871|NCT04977843|Procedure|EARLY BRONCHOALVEOLAR LAVAGE|E-BAL done with instillation of 100cc normal saline and sucked out
15735872|NCT04977830|Device|Xenon-129|Patients will undergo a hyperpolarized MRI with administered Xenon gas
15735873|NCT04977817|Dietary Supplement|Similac Probiotic Tri-Blend|Probiotic dietary supplement, Similac Probiotic Tri-Blend
15735874|NCT04977804|Other|Exercise|The interventions are a form or exercise, specifically resistance exercise.
15735875|NCT04977804|Other|Eccentric plus blood-flow restriction|Eccentric plus blood-flow restriction
15735876|NCT04977791|Drug|Anti-PD-1/PD-L1 monoclonal antibody|Observe a situation before and after immunotherapy
15735877|NCT04977778|Drug|Fatty Acids Compounds (F.A.G.) Mouthwash|Fatty Acids Compounds (F.A.G.) Mouthwash
15735878|NCT04977778|Drug|Stannous Fluoride (SF) Mouthwash|Stannous Fluoride (SF) Mouthwash
15735879|NCT04977739|Diagnostic Test|No intervention|No intervention
15735880|NCT04977726|Behavioral|STRIVE curriculum|STRIVE is adapted from the Road to Mental Readiness curriculum, developed by the Department of National Defence in Canada. It is comprised of a 4-hour formal education session where participants are provided knowledge, skills and resources specific to self-assessment for mental wellness and effective mindfulness strategies. High fidelity simulation sessions are then utilized to reinforce and apply mindfulness techniques learned in the formal session.
15735881|NCT04977713|Other|Acupressure|A researcher sat behind the women to comfortably access the sacral area and be in the appropriate position. The researcher then applied deep rotational pressure on the BL32 points until her nail bed colour changed to prevent any discomfort in the participants
15735882|NCT04977713|Other|Shower|During uterine contractions, these participants took a shower while standing, with a researcher on hand to assist her (average time: 20 minutes). The water's temperature was between 22°C and 26°C.
15735883|NCT04977700|Behavioral|Intervention Group|Test the developed algorithm that delivers location-based, tailored sun safety advice to Strava users through Strava comments for acceptability, ways of interacting with it, and barriers/willingness to allowing access.
15735884|NCT04977674|Drug|Naltrexone|Pre-treatment with naltrexone 45 min before the ketamine infusion.
15735885|NCT04977674|Drug|Placebo|Pre-treatment with placebo 45 min before the ketamine infusion.
15735886|NCT04977674|Drug|Ketamine|Participants receive intravenous ketamine infusion (0.5 mg/kg over 40 min) at both study visits.
15735887|NCT04977661|Drug|Vitamin E|Vitamin E is one of the body's most effective chain-breaking antioxidants that has shown to delay the pathogenesis of NASH.
15735888|NCT04977661|Drug|Ursodeoxycholic acid|is a metabolic by-product of intestinal bacteria and has been proven to be useful in the non-surgical treatment of cholesterol gallstones and primary biliary cirrhosis (PBC)
15735889|NCT04977661|Drug|Pentoxifylline|"it is a well-tolerated medication that improves blood
~viscosity and erythrocyte rheological characteristics in individuals with peripheral vascular disease 20. In addition, PTX is a nonspecific phosphodiesterase inhibitor that increases cyclic adenosine monophosphate (cAMP) levels while decreasing TNF-a gene transcription"
15735890|NCT04977609|Behavioral|VR+MUSIC|A novel VR intervention designed for upper limb motor rehabilitation in post-stroke hemiparetic patients consisting in 10 daily sessions of 30 minutes, over 2 weeks, supervised by a physical therapist.
15735891|NCT04977609|Behavioral|VR|A novel VR intervention designed for upper limb motor rehabilitation in post-stroke hemiparetic patients consisting in 10 daily sessions of 30 minutes, over 2 weeks, supervised by a physical therapist.
15735892|NCT04977609|Behavioral|TAU|Traditional post-stroke upper limb motor rehabilitation under the supervision of a physical therapist, for 0 daily sessions of 30 minutes, over 2 weeks.
15735893|NCT04977596|Other|No intervention|Retrospective study without intervention
15735894|NCT04977583|Behavioral|Unmet Need Screening|"Participants are screened by phone for unmet social needs (e.g., utility insecurity, social isolation), hereafter referred to as the index screen. The index screen occurs prior to randomization."
15735895|NCT04977583|Behavioral|Unmet Need Referral - Resource Sheet|Participants receive a Resource Sheet(s) tailored to the unmet need(s) identified in the index screen. For each unmet need, a Resource Sheet will include the names of available resource within the VA and/or the local community that can help address the unmet need and contact information (address, phone, website, email) and hours of operation.
15735896|NCT04977583|Behavioral|Unmet Need Referral Assistance|Participants receive assistance from a Social Worker (SW) to facilitate connection to resources that can help to address unmet need(s) identified in the index screen. Assistance includes 1) conducting a standardized bio-psychosocial assessment; 2) motivational interviewing methods to uncover details of the Veteran's unmet needs and identify barriers to resolving the unmet needs, and; 3) developing an action plan for the Veteran to connect with resources and address needs. The SW will conduct initial follow-up by phone one week after the interview/action plan development, with planned subsequent phone outreach every two weeks for up to seven weeks.
15735897|NCT04977570|Drug|SYHA1805 tablets|Oral tablets of SYHA1805 with three pre-designed doses
15735898|NCT04977570|Drug|Placebo|Oral tablets of placebo with matching doses
15735899|NCT04977557|Dietary Supplement|Thiamine|Injection Thiamine 200 mg daily intravenously for 1 week followed by Tablet Thiamine 100mg bid for remaining 11 weeks
15735900|NCT04977544|Device|vert|On the basis of sertraline drug treatment, phobia patients were given 2d/times from the 5th week, each 35-45min VR exposure treatment, 15 times as a course of treatment.
15735901|NCT04977544|Drug|Sertraline|Sertraline was given as a single drug, with an initial dose of 50 mg/d, and gradually increased to the maximum dose of 200 mg/d after 2 weeks. The treating physician will determine the specific dose adjustment according to the patient's condition.
15735902|NCT04977518|Other|no intervention|no intervention
15735903|NCT04977505|Device|pushlock|The surgery procedure was performed with pushlock for fixation
15735905|NCT04977492|Procedure|extracapsular release of lateral retinaculum|A new kind of surgery which releases the lateral retinaculum from outside the knee capsular, maintaining the structure of the knee capsular.
15735906|NCT04977479|Biological|Pfizer-BioNTech COVID-19 Vaccine (comirnaty)|mRNA vaccine for the prevention of COVID-19. Single dose (0.3mL) via IM.
15735907|NCT04977479|Other|Placebo|Commercially available sterile, preservative-free 0.9% Sodium Chloride Injection, USP. Volume to match active vaccine controlling for and delivered as a single dose via IM.
15735908|NCT04977453|Drug|GI-101|Recommended phase 2 dose of GI-101 will be administered via IV infusion Q3W up to 2 years (approximately 35 years).
15735909|NCT04977453|Drug|Pembrolizumab|Pembrolizumab will be administered at a dose of 200 mg as IV infusion Q3W.
15735910|NCT04977453|Drug|Lenvatinib|Lenvatinib will be administered at an approved dose orally.
15735911|NCT04977453|Radiation|Local Radiotherapy|Patients will receive SBRT prior to the first dose of GI-101
15735912|NCT04977440|Dietary Supplement|Whey protein|"Patients were randomly divided into two groups: Group (A): Enteral feeding with normal protein intake ( 1.0 gm pin /kg/day ) Group (B): Enteral feeding with high protein intake ( 1.5- gm open /kg/day ) -Patient's- nonprotein- caloric intake was calculated according to REE :(25xactual body weight in kg ) and received it as follow : 1/2 the calculated amount of caloric intake in DAY 1 3/4 of the calculated amount of caloric intake in DAY 2
~-Full calculated caloric amount in DAY 3
~This regimen was followed long as the patient was tolerating the amount of feeding, and in case of intolerance:
~The volume of feeding boluses was decreased or Increase the time interval between boluses or IV metoclopramide or erythromycin was given"
15735913|NCT04977427|Drug|Dextenza 0.4Mg Ophthalmic Insert|Dexamethasone inserted into lower punctum at the end of cataract surgery in order to control inflammation in the eye for the following 30 days after surgery.
15735914|NCT04977427|Drug|Prednisolone Acetate 1% Oph Susp|Standard Prednisolone taper following cataract surgery, QID for one week, followed by TID for one week, BID for one week, and QDaily for one week, then stop.
15735915|NCT04977414|Behavioral|Making Data Count Training intervention|The Making Data Count training intervention was designed by NHS-Improvement to improve knowledge about SPC charts and to increase their uptake. Training sessions are tailored for two sets of attendees: board members and data analysts. Board member and analyst training sessions are delivered as close as possible in time, typically within the same month. Training sessions for board members are usually delivered over about one-and-a-half hours and focus more heavily on the benefits of control charts compared to other charts. Training sessions for analysts are usually delivered over three hours and focus more heavily on the structure and interpretation of the individual and moving range charts (X-mR charts).
15735916|NCT04977401|Procedure|Endoscopic submucosal dissection|Dissecting superficial gastric or rectal lesion/polyp after injection of the submucosa for lifting, using a electrosurgical knife through the endoscope
15735917|NCT04977401|Device|use of Orise Gel as lifting agent for endoscopic submucosal dissection|Injection of some colloidal solution (ORISE gel) in the submucosal layer in order to obtain long lifting effect and thus allowing the endoscopist to dissect under the lesion.
15735918|NCT04977401|Device|use of glycerol as lifting agent for endoscopic submucosal dissection|Injection of some colloidal solution (glycerol) in the submucosal layer in order to obtain long lifting effect and thus allowing the endoscopist to dissect under the lesion.
15735919|NCT04977388|Drug|Droxidopa|Subjects will self-administer capsules of Droxidopa by mouth twice daily for six weeks.
15735920|NCT04977388|Other|Placebo|Subjects will self-administer capsules of placebo by mouth twice daily for six weeks.
15735921|NCT04977375|Drug|Pembrolizumab|Pembrolizumab 400mg administered intravenously on Day 1, and then beginning 6 weeks post-surgery, subjects will receive 400 mg pembrolizumab every 6 weeks
15735922|NCT04977375|Radiation|Stereotactic Radiation Therapy|Standard of care stereotactic radiation of 24 grays over 3 days, administered beginning on Day 7
15735923|NCT04977375|Procedure|Surgical Resection|Standard of care surgical resection of tumor on Day 10-28
15735924|NCT04977362|Other|Enhanced Recovery After Surgery|Enhanced recovery after surgery is a multimodal, transdisciplinary care approach for patients undergoing surgical procedures. It is implemented in various surgical specialties, among others in cardiac surgery. The care approach aims at promotion of recovery of the patients throughout their perioperative process, reduction of complications, and early return to normal activities.
15735925|NCT04977362|Other|Treatment as Usual|treatment as usual according to standard care in heart valve surgery
15735926|NCT04977349|Other|Manual Therapy|This group will be treated by manual therapy: suboccipital inhibition, myofascial extracavitary treatment in (superior trapezius fibers, ECOM, masseter and temporalis) and intracavitary muscles (medialis and lateral pterygoid muscles).
15735927|NCT04977349|Other|Exercise program|Isometric exercises for: cranial protrusion, mouth opening, laterality cervical movement and cervical coordination by laser assessment. And the manual therapy from the Active Comparator group.
15735928|NCT04977336|Drug|VX-548|Tablets for oral administration.
15735929|NCT04977336|Drug|HB/APAP|Capsules for oral administration.
15735930|NCT04977336|Drug|Placebo (matched to VX-548)|Placebo matched to VX-548 for oral administration.
15735931|NCT04977336|Drug|Placebo (matched to HB/APAP)|Placebo matched to HB/APAP for oral administration.
15735932|NCT04977323|Other|TICK-B group|These interventions will use as distraction techniques.
15735933|NCT04977310|Device|CardioMEMS|Cardio-MEMS-guided Post-LVAD cardiac unloading and recovery
15735934|NCT04977297|Behavioral|Move to Music Intervention (M2M)|The move to music (M2M) intervention pairs exercise with only music (no video), providing only audio stimulation. The intervention will be provided via an audio playlist that can be played on a phone, tablet, or computer. Each session lasts 10-15 minutes.
15735935|NCT04977297|Behavioral|Move to Music -Video (M2M-V) Intervention|The move to music video (M2M-V) intervention pairs exercise with both music and video, thus providing both audio and visual stimulation. The intervention will be provided via an audio and video playlist that can be played on a phone, tablet, or computer. Each session lasts 10-15 minutes.
15735936|NCT04977284|Device|DS7R, Digitimer, UK|Non-surgical spinal cord stimulation will be applied and electrical activity of muscles will be recorded.
15735937|NCT04977271|Drug|Venlafaxine|The Immediate Release generic formulation of this drug will be used due to its ability to be crushed for those patients who rely on parenteral administration of medications.
15735938|NCT04977258|Other|Treadmill aerobic exercise without water intake|The volunteers will be submitted to a cardiovascular rehabilitation session with 40 minutes of treadmill aerobic exercise followed by 60 minutes of recovery at the supine position.
15735939|NCT04977258|Other|Treadmill aerobic exercise with water intake of a predetermined amount.|The volunteers will be submitted to a cardiovascular rehabilitation session with 40 minutes of treadmill aerobic exercise and water intake followed by 60 minutes of recovery at the supine position.
15735940|NCT04977258|Other|Treadmill aerobic exercise with water intake according to the desire to drink|The volunteers will be submitted to a cardiovascular rehabilitation session with 40 minutes of treadmill aerobic exercise and water intake followed by 60 minutes of recovery at the supine position.
15735941|NCT04977245|Other|Mindfulness-Based Stress Reduction|Eight MBSR sessions of 1.5 hours per week
15735942|NCT04977245|Other|Self-Guided Mindfulness eCourse|Six weeks of a mindfulness ecourse, and two weeks of coping skills training led by a licensed neuropsychologist
15735943|NCT04977232|Drug|Escitalopram|Selective serotonin reuptake inhibitors (SSRI) were most commonly used first line pharmacotherapy for depression.
15735944|NCT04977232|Behavioral|Game intervention|"Dancing Line is a commercial music game. It is simple for participants to operate and there is no need for prior gaming experience. Participants will be instructed to play the game for about 30-60 minutes at least three times per week."
15735945|NCT04977219|Behavioral|Prism Adaptation Training|Therapists administering PAT followed the protocol developed by the Kessler Foundation (2014).PAT sessions lasted approximately 30 minutes during which patients with left sided neglect don 20 diopter prism goggles deviating their visual field to the right while aiming their finger at a series of visual targets.
15735946|NCT04977206|Other|Mutual Goal-Setting Education|Nurses will receive both written and verbal instruction on mutual goal-setting with patients using SMART methodology
15735947|NCT04977193|Biological|LY011|CAR-T
15735948|NCT04977180|Drug|Cardioprotection|Preventive beta blocker (metoprolol or carvedilol) and an ACE inhibitor (lisinopril)
15735949|NCT04977167|Drug|HG146|HG146 is available as Capsule at a unit dose strength of 5 mg and 10 mg.
15735950|NCT04977167|Drug|PD-(L)1 antibody|PD-(L)1 Antibody is available as solution for infusion or lyophilized powder for reconstitution to be administered Q3W. It will be administered as an IV infusion for 30 minutes.
15735951|NCT04977154|Other|Primary prevention|The primary prevention that the trainers put in place for the hockey players
15735952|NCT04977141|Other|Decisional Conflict Scale|Decisional Conflict Scale
15735953|NCT04977128|Drug|89Zr-KN035|Patients will receive a tracer (10 mg, IV) dose of Zr-89 (2-3mCi) labelled KN035 (89Zr- KN035)
15735954|NCT04977115|Procedure|Intraocular caliper-assisted capsulotomy|Intraocular caliper is a modified intraocular caliper with standard calibration on the rinse needle.
15735955|NCT04977115|Procedure|Verion navigation system-assisted capsulotomy|Verion Image Guided System (Alcon Laboratories, Inc.) is a digital image guidance system consisting of a diagnostic reference unit and a surgery pilot for intraoperative surgical assistance. The device can be used to align toric intraocular lens during surgery as well as support manual creation of a capsulorhexis with a predefined target diameter.
15735956|NCT04977102|Procedure|Intraocular caliper-assisted capsulotomy|Intraocular caliper is a modified intraocular caliper with standard calibration on the rinse needle.
15735957|NCT04977102|Procedure|Verion navigation system-assisted capsulotomy|Verion Image Guided System (Alcon Laboratories, Inc.) is a digital image guidance system consisting of a diagnostic reference unit and a surgery pilot for intraoperative surgical assistance. The device can be used to align toric intraocular lens during surgery as well as support manual creation of a capsulorhexis with a predefined target diameter.
15735958|NCT04977089|Diagnostic Test|lipid profile test .|Assesment of lipid profile of patients (cholesterol level ,TG ,VLDL )
15735959|NCT04977076|Other|Uninterrupted NOAC use|Continuing NOAC use in advance of elective CAG or PCI.
15735960|NCT04977076|Other|Interrupted NOAC use|Usual care, interruption of NOAC prior to procedure.
15735961|NCT04977063|Device|Atmo gas capsule|The Atmo Gas Capsule measures the capsules location and motility/transit times through gas sensing capabilities
15735962|NCT04977063|Device|SmartPill|The SmartPill measures the capsules location and motility/transit times through pH sensing
15735963|NCT04977050|Diagnostic Test|Quidel quickvue antigen test for COVID-19|rapid antigen test on nasal swab specimen for COVID-19
15735966|NCT04977024|Biological|COVID-19 Vaccine|Receive EUA SARS-CoV-2 vaccine IM
15735967|NCT04977024|Other|Diagnostic Laboratory Biomarker Analysis|Correlative studies
15735968|NCT04977024|Biological|Synthetic MVA-based SARS-CoV-2 Vaccine COH04S1|Given IM
15735969|NCT04977011|Other|relaxing music|30 minutes relaxing music for continuity 3 days since admission
15735970|NCT04976998|Diagnostic Test|imaging|imaging by ultrasonography and nerve conduction studies will be done for both grups
15735971|NCT04976985|Procedure|Osteopathic Manipulative Therapy (OMT)|"Osteopathic Manipulative Therapy (OMT) is a non-pharmacological, noninvasive form of manual medicine. Osteopathic physicians receive special training in the musculoskeletal system to detect somatic dysfunction. Osteopathic physicians then move a patient's muscles and joints using techniques that include stretching, gentle pressure and resistance to improve muscle tonicity, treat structural abnormalities, relieve joint restriction, and decrease activation of the pain proprioception pathway.
~OMT Standardized Protocol A:
~Occipital- Alanto release
~Muscle energy and soft tissue to mid trapezius muscle
~Muscle energy to cervical spine in all three planes of flexion/extension, rotation and side bending
~Screening for tender points of C2-C6 at transverse and spinous processes and treatment with counterstain if tender point identified
~Soft tissue to cervical paraspinal muscles
~Myo-fascial release of frontal forehead
~CV4 cranial technique"
15735972|NCT04976985|Other|Standard of care|Receiving standard of care for migraine headaches with pharmacological medications, with no more than two prophylactic medications during the study period. Participants may also take abortive migraine medications.
15735973|NCT04976972|Device|NAVIO/CORI Surgical System|Total knee replacement with robotic assistance
15735974|NCT04976972|Procedure|Non-robotic conventional instrumentation|Total knee replacement with non-robotic conventional instrumentation
15735975|NCT04976959|Drug|High Fiber supplement|The supplement consists of a mixture of soluble fibers (from inulin and fibersol-2) and insoluble fibers (from oat bran, corn bran, wheat bran and sorghum bran) and it will be consumed as a drink.
15735976|NCT04976946|Other|Comprehensive questionnaire|Multi-staged, international Delphi study that aims to establish criteria for standardised complication reporting in Urology.
15735978|NCT04976920|Diagnostic Test|Overture Metabolomics Embryo Selection|Patients will have their embryos selected for transfer based on morphology alone. The embryo transfer outcome will be compared to the metabolomics result to determine the NPV and PPV of metabolomics vs implantation.
15735979|NCT04976907|Device|Contactless vital sign information collection|Collection of facial blood flow and temperature information via conventional and infrared/thermal video of the face for the purpose of estimating vital signs using machine learning-based computational models.
15735980|NCT04976894|Other|open|open
15735981|NCT04976881|Behavioral|Medication Reconciliation (MedRec) Tool|Patients will receive a print MedRec tool, generated via the EHR, which includes a list of medications prescribed according to the patient record. Patients are asked to review this list, to add/remove drugs to reflect actual use, to note how they are taking each medication, and to describe any concerns.
15735982|NCT04976881|Behavioral|Provider Alert and Decision Support|During the clinic visit, an automated, EHR alert will notify the provider that the patient is a woman of reproductive age with T2DM and should receive counseling on the importance of glycemic control, the use of contraception until glycemic control is achieved, and the benefits of folic acid.
15735983|NCT04976881|Behavioral|PREPSheet|When patients leave an encounter, they will receive a patient-friendly educational material (a.k.a. the PREPSheet) that reviews potential risks of pregnancy in the context of T2DM and highlights the importance of: 1) achieving glycemic control through diabetes self-care, 2) using effective contraception until glycemic control is achieved and pregnancy is desired, 3) discussing medication use with a provider if planning or becoming pregnant, and 4) taking folic acid daily to reduce increased risk of neural tube defects.
15735984|NCT04976881|Behavioral|Text Messaging|Within ~5 days of their index clinic visit, intervention patients will begin to receive daily, unidirectional text messages to reinforce diabetes self-care behaviors.
15735985|NCT04976868|Drug|Pimecrolimus 1% Top Cream|Elidel® as prescribed within routine clinical practice
15735986|NCT04976855|Drug|INDV-2000|Capsule for oral administration
15735987|NCT04976855|Drug|Placebo|Capsule for oral administration
15735988|NCT04976855|Drug|SUBOXONE® sublingual film|Administered either under the tongue (sublingual) or between the gum and cheek (buccal)
15735989|NCT04976842|Device|OFA|Anesthesiology technique based on Mulier protocol. Before induction, loading dose of dexmedetomidine 0,25mcg/kg (max 20mcg). Induction with dexmedetomidine 0,1mcg/kg, lidocaine 1mg/kg, ketamine 0,1mg/kg plus propofol 2mg/kg plus rocuronium1mg/kg IBW (if required). Maintenance with dexmedetomidine 0,1mcg/kg/h, lidocaine 1mg/kg/h, ketamine 0,1mg/kg/h and propofol infusion adjusted according to bispectral index indication ( BIS maintained 40-60). 15 minutes prior to end of surgery, the dose of drugs is reduced to dexmedetomidine 0,05mcg/kg/h, lidocaine 0,5mg/kg/h, ketamine 0,05mg/kg/h.
15735990|NCT04976842|Drug|OBA|Total intravenous anesthesia with propofol for maintenance of anesthesia. Fentanyl 2mcg/kg only at induction and infusion of propofol and remifentanil for maintenance, with doses adjusted according to bispectral index indication ( BIS maintained 40-60).
15735991|NCT04976829|Device|Antibiotic stewardship and healthcare-associated infections surveillance assisted by computer|Implementation - in our tertiary care university hospital - of a computerized-decision support system (CDSS) facilitating antibiotic stewardship and of an electronic surveillance software (ESS) facilitating infection prevention and control activities
15735992|NCT04976816|Procedure|peri-levator betamethasone injection|The injection dose will be 1.5 ml of betamethasone suspension (1 ml contains 5 mg betamethasone dipropionate &2 mg betamethasone sodium phosphate). The needle will be introduced percutaneously superior to the globe and advanced towards the orbital roof to a depth of approximately 15 mm where the injection is delivered. The injection will be repeated every 4-6 weeks according to the clinical response up to 3 injections.
15735993|NCT04976816|Procedure|peri-levator triamcinolone injection|The needle will be introduced percutaneously superior to the globe and advanced towards the orbital roof to a depth of approximately 15 mm where 1ml (40mg/ml) triamcinolone acetate is injected. The injection will be repeated every 4-6 weeks according to the clinical response up to 3 injections.
15735994|NCT04976816|Procedure|peri-levator and retrobulbar betamethasone injection|In addition to peri-levator betamethasone injection for UER, a retrobulbar injection for proptosis will be given with the needle introduced through the skin of the lateral one-third of the lower eyelid and passed posteriorly, medially, and upward to reach the retrobulbar space.
15735995|NCT04976816|Procedure|peri-levator and retrobulbar triamcinolone injection|In addition to peri-levator triamcinolone injection for UER, a retrobulbar injection for proptosis will be given with the needle introduced through the skin of the lateral one-third of the lower eyelid and passed posteriorly, medially, and upward to reach the retrobulbar space.
15735996|NCT04976803|Other|Determination of ATM alteration status.|ATM alterations identified using NGS profiles with ATM protein expression levels from tumor tissue assessed by IHC.
15736059|NCT04976192|Combination Product|XOLAIR® Injection|XOLAIR (omalizumab) injection is supplied as a single dose PFS. Each PFS of XOLAIR contains 150 mg of omalizumab in 1 mL of solution.
15736060|NCT04976179|Drug|Ferric carboxymaltose|Ferric carboxymaltose to be given as an intravenous infusion
15736061|NCT04976179|Drug|Ferrous sulfate|Ferrous sulphate tablet to be taken orally
15736062|NCT04976166|Behavioral|Education|More informed and detailed education
15736063|NCT04976166|Behavioral|Education|Shared decision making
15735997|NCT04976790|Behavioral|Chinese Tuina therapy|Firstly, the patient is in the prone position, and the doctor use the method of rolling or kneading the Bladder meridians on both sides of the spine. The waist will be focused on to manipulate preferentially and then using the same technique on the patient's back, buttocks and lower limbs. Secondly, the physician will perform the manipulation on the patient's waist and the posterolateral side of the lower limbs by pressing, kneading, plucking. The doctors press the acupoints, including Mingmen(DU04),Shenshu(BL23),Yaoyangguan(DU03),Huantiao(GB30), Weizhong(BL40),Chengshan(BL57),and Ashi points, with the elbow or the thumb to achieve Deqi sensation. Thirdly, the The doctor uses the method of pressing acupoints, including Tianshu(ST25),Qichong(ST30),Chongmen(SP12),Daimai(GB26),Jingmen(GB25) on both sides. Fourthly, the patient is required to face the doctor in a lateral position for pulling manipulation on the both sides of lumbar vertebrae.
15735998|NCT04976790|Drug|Flurbiprofen Cataplasms group (FCG).|One Flurbiprofen Cataplasm was applied to the left and right sides of the waist, twice daily, for 14 days
15736001|NCT04976751|Drug|Percutaneous electrical nerve stimulation treatment|Using the percutaneous electrical nerve stimulation instrument to different points of the body
15736002|NCT04976738|Drug|Cybis™ 10:25 THC:CBD oil|Cybis™ 10:25 containing 10 mg/mL of D9-THC and 25 mg/mL of CBD, formulated in medium chain triglycerides (MCT)
15736003|NCT04976725|Other|Osteopathic Manipulative Therapy|"75 individuals will be included in our study, including 3 groups: control group (N= 25), osteopathic manipulative technique (n= 25), myofascial relaxation group (n=25). Which group of individuals will be determined by randomizing them with closed envelope method.
~Osteopathic Manipulative Therapy and myofascial relaxation treatment applications will be applied 2 days a week, for periods of 30 min for 4 weeks."
15736004|NCT04976686|Other|Diet modification|Participants will reduce their carbohydrate consumption to 80g daily
15736005|NCT04976673|Drug|Triamcinolone Acetonide|The OLP on the other side was treated by daily sticking a cut-to-size carrier with 0.05% triamcinolone acetonide for 8 days
15736006|NCT04976673|Procedure|Photodynamic Therapy|the olp was photosensitized with methylen blue and was irradiated with a semiconductor laser with a wavelength of 650 nm, using a dose of 120 J / cm2 and power density
15736007|NCT04976660|Drug|TT-4|TT-4 orally administered QD starting at 200 mg and will be increased to 800 mg (dosing may be increased to BID, if appropriate based on emerging safety, PK or PD data).
15736008|NCT04976647|Drug|HLX10+chemo|HLX10 300mg IV Q3W; carboplaitin (AUC5 or 6) IV Q3W + nab-paclitaxel (260mg/m2) IV Q3W for 4-6 circle
15736009|NCT04976647|Drug|HLX10+HLX07+chemo|HLX07 1500mg IV q3w; HLX10 300mg IV Q3W; carboplaitin (AUC5 or 6) IV Q3W + nab-paclitaxel (260mg/m2) IV Q3W for 4-6 circle
15736010|NCT04976647|Drug|HLX10+HLX07|HLX07 1500mg IV q3w; HLX10 300mg IV Q3W;
15736017|NCT04976582|Device|dry needle|modalities including transcutaneous electrical nerve stimulation (TENS); electrical muscle stimulation (EMS); and interferential current (IFC). Physical agents including ultrasound, hot packs, and cold packs. Exercise including McKenzie exercises) will be administered.
15736018|NCT04976569|Device|STN-DBS stimulation pattern change|Deep brain stimulation (DBS) is an elective surgical procedure in which electrodes are implanted into certain brain areas.We use specific STN-DBS stimulation pattern to regulate sleep architecture.
15736019|NCT04976556|Device|Histolog Scanner|imaging of fresh lumpectomy specimens with the Histolog Scanner, confocal microscopy scanning medical imaging device
15736020|NCT04976543|Drug|low molecular weight heparin and/or warfarin|low molecular weight heparin and/or warfarin was given. When using warfarin, international normalized ratio (INR) was detected every 3-4 days and adjusted carefully by 0.75mg dosage until achieve the target level of 2-3.
15736023|NCT04976504|Device|Oxygen reserve index|This is an observational study of the routine clinical practice with no specific additional interventions required. The investigators enrolled the ASA physical status I to III patients scheduled for elective surgery with planned arterial catheter placement before induction. ORi and standard monitors were placed. The patients were preoxygenated and received anesthesia induction as routine clinical practice. Intubation was done by video-laryngoscope. The endotracheal tube was not connected to the breathing circuit to avoid apneic oxygenation. Ventilation was resumed when SpO2 fell to 90%. ORi and SpO2 were recorded every ten seconds.
15736024|NCT04976491|Dietary Supplement|CD-C-Food|CD patients combined with the characteristics of Chinese diet, remove the refined food, and combined with food intolerance detection method to check the corresponding food
15736025|NCT04976478|Drug|Nimotuzumab|Patients receive Nimotuzumab: 200mg, intravenous infusion, weekly for 6 weeks.
15736064|NCT04976166|Behavioral|Education|education as usual
15736065|NCT04976153|Biological|aSMDC|Autologous Muscle Derived Cells for injection into the external anal sphincter
15736026|NCT04976478|Radiation|EBRT combined with brachytherapy|"IMRT/VMAT are adopted. A total dose of 45-50.4 Gy, 1.8~2.0Gy/f, 25~ 28F in pelvic and/or extension filed. For patients with metastasis in pelvic lymph node and abdominal para-aortic lymph node, the dose of radiation in local lesion will be increased to 60~66Gy. For patients at stage IIIB, concurrent radiation will be given in parametrial extension or in the late course the dose will be increased to 60Gy.
~Brachytherapy: Three dimensional high dose rate brachytherapy is used with HR-CTV D90 cumulative dose of 80~85Gy (EQD2); If the tumor diameter is ≥4cm, HR-CTV D90 cumulative dose is ≥87Gy (EQD2). Brachytherapy combined with external beam radiotherapy will be completed within 8 weeks."
15736027|NCT04976465|Drug|Anticoagulation|"Drug:
~Prednisone 5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response Other Names: Pred
~Hydroxychloroquine 100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.
~Other Names: HCQ
~Aspirin 100mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response to 32 weeks of pregnancy. 75mg po, once per day (Qd) to 34 weeks of pregnancy. 50mg po, once per day (Qd) to 36 weeks of pregnancy.
~Other Names: Asp
~Low molecular weight heparin Enoxaparin 40-60mg, ih, Subcutaneous injection, once per day (Qd) or twice per day (Bid) if needed and adjusted due to patient response.
~Other Names: LMWH"
15736028|NCT04976465|Drug|Without Anticoagulation|"Drug:
~Prednisone 5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response Other Names: Pred
~Hydroxychloroquine 100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.
~Other Names: HCQ"
15736029|NCT04976452|Other|Multi-component teaching content|The students assigned to Group 1 will undergo interactive module training by the American Medical Association which outlines how to properly measure blood pressure manually following the American Heart Association guidelines. Following completion of the module, students will be presented with a powerpoint lecture by the Primary Investigator on Blood Pressure. Students will then undergo a competency examination that assesses their ability to measure blood pressure following the guidelines of the American Heart Association.
15736030|NCT04976439|Other|co-occuring mutation|APC, TP53, PIK3CA, KRAS APC, TP53, PIK3CA, MLH1 APC, TP53, PIK3CA, KRAS, and MLH1 APC, TP53, PIK3CA
15736031|NCT04976413|Behavioral|Eye Movement Desensitization and Reprocessing (EMDR) psychotherapy|Experimental arm will receive eight phase EMDR treatment using manualized standard protocol. Selection of targets for reprocessing through EMDR will be made according to adaptive information processing model's postulations, that links traumatic events with the symptoms of depression and anxiety. Time period allocated to EMDR treatment is 12-14 weeks.
15736032|NCT04976413|Behavioral|Counselling as usual|Control arm will receive counseling as usual for 12-14 weeks
15736033|NCT04976400|Procedure|semi-individualized total knee replacement treatment with a gender-specific design|Patients in the experimental group received a semi-individualized total knee replacement treatment with a gender-specific design.
15736034|NCT04976400|Procedure|Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA)|Patients in the control group received imported Zimmer total knee replacement prostheses (Zimmer, Warsaw, IN, USA).
15736038|NCT04976374|Drug|Dexmedetomidine and Gabapentin|Administration of intravenous dexmedetomedine for post operative analgesic purposes in combination with gabapentin
15736039|NCT04976374|Other|Saline|Intravenous Saline 0.9% for placebo purposes
15736040|NCT04976361|Other|PRP was done using visulas green laser machine (Carl Zeiss Meditec AG Geoschwitzer Str. 51-52,07745 jena, Germany)|PRP was done using visulas green laser machine (Carl Zeiss Meditec AG Geoschwitzer Str. 51-52,07745 jena, Germany)
15736041|NCT04976335|Device|Versawrap membrane|Versawrap membrane will be placed between distal radius plate and flexor tendons
15736043|NCT04976309|Drug|Lu AG09222|Single dose
15736044|NCT04976309|Drug|Placebo|Single dose
15736045|NCT04976296|Diagnostic Test|MRD detection|The Geneplus OncoMRD lung assay is used to detect the MRD status.
15736046|NCT04976283|Drug|Pioglitazone|Pioglitazone with (or without) metformin and/or DPP4 inhibitor (no SGLT2 inhibitor). The maximum dose for metformin would be 2.5 g/day, while for pioglitazone would be 45mg/day. The maximum dose for DPP4 inhibitor would be 100mg/day.
15736047|NCT04976283|Drug|Empagliflozin|Empagliflozin with (or without) metformin and/or DPP4 inhibitor (no pioglitazone). The maximum dose for metformin would be 2.5g/day, while for empagliflozin would be 25mg/day depending on follow up blood sugar levels and tolerability. The maximum dose 100mg daily.
15736048|NCT04976283|Drug|Pioglitazone + Empagliflozin|Pioglitazone with (or without) metformin and/or DPP4 inhibitor, plus empagliflozin. The maximum dose for metformin would be 2.5g/day; for pioglitazone would be 45mg/day and 25mg/day for empagliflozin, and 100mg daily for DPP4 inhibitors (depending on follow up blood sugar levels and tolerability).
15736049|NCT04976270|Drug|GLPG3667|GLPG3667 capsules
15736050|NCT04976270|Drug|Placebo|Matching placebo capsules
15736055|NCT04976244|Procedure|Intravitreal injection|Intravitreal injection to the regimen pro re nata
15736056|NCT04976218|Biological|TGFβR-KO CAR-EGFR T Cells|Enrolled patients will be administered TGFβR-KO CAR-EGFR T Cells in 3+3 based escalation manner.
15736057|NCT04976205|Radiation|Total Marrow (Lymph-node) Irradiation|To the standard procedure for TMI/TMLI target definition, based on simulation WB-CT acquired 10/15 days before BMT, we acquire: WB- magnetic resonance imaging (MRI) the same day of the simulation WB-CT. A verification WB-CT will be performed 3/4 days before the delivery. Plans will be optimized with Volumetric Modulated Arc Therapy (VMAT) technique.
15736058|NCT04976192|Combination Product|TEV-45779|TEV-45779 (Omalizumab) solution for injection 150 mg/mL prefilled syringe
15736066|NCT04976153|Other|Placebo|Placebo control is the vehicle solution used for the study product
15736067|NCT04976140|Biological|PN-101|"PN-101: human umbilical cord mesenchymal stem cell (UC-MSC) derived allogeneic mitochondria
~3 or 6 subjects are enrolled in each dose group in line with the traditional 3+3 rule-based method, and the investigator intravenously administers a single-dose of the investigational product according to the planned dose."
15736068|NCT04976127|Drug|Talineuren|Talineuren is a liposomal formulation of the GM1 Ganglioside for intravenous administration
15736069|NCT04976114|Procedure|Story book with information about surgery techniques|Presurgery use of Story book. The parents with the child read a book with information about surgery techniques the days before surgery.
15736070|NCT04976114|Procedure|Video with information about surgery techniques|Presurgery use of video. The parents with the child watch a video with information about surgery techniques the days before surgery.
15736071|NCT04976114|Procedure|Story book and Video with information about surgery techniques|Presurgery use of video and story book. The parents with the child watch a video and read a book (both) with information about surgery techniques the days before surgery.
15736072|NCT04976101|Device|Sinosuidal Galvanic Vestibular Stimulation|stimulus will be given by applying paste electrodes over the mastoid processes and plugging the leads into a battery driven-stimulus box, which when activated by a switch, will provide a very low frequency (VLF) bipolar, ± 2 mA, 0.025 Hz oscillating current sGVS between the mastoids
15736073|NCT04976101|Device|Placebo|When assigned to placebo arm of the study, the patients will undergo same procedure as the treatment, only current will not be passed. (the device will still be placed on the mastoid process)
15736074|NCT04976088|Drug|Diclofenac Sodium 140 mg medicated plaster|Test product: Diclofenac Sodium 140 mg medicated plaster, topical application once a day
15736075|NCT04976088|Drug|Diclofenac epolamine (DIEP) 180mg medicated plaster, Flector|Reference product: Active-comparator, Diclofenac epolamine (DIEP) 180 mg medicated plaster, Flector®, topical application once a day
15736076|NCT04976088|Drug|Placebo|Placebo: Placebo plaster, topical application once a day.
15736077|NCT04976075|Other|no interventions|no interventions
15736078|NCT04976062|Diagnostic Test|Combined near-infrared spectroscopy and intravascular ultrasound imaging (NIRS-IVUS)|The NIRS-IVUS technique is an intravascular imaging technique, combining morphological information derived from intravascular ultrasound (IVUS) and molecular information on plaque composition, namely its respective lipid-core burden, using spectral differences between cholesterol and collagen, detected by near-infrared spectroscopy (NIRS). A combined NIRS-IVUS pullback results in a color-coded map indicating the probability of lipid-rich plaque presence in yellow, co-registered to the corresponding IVUS cross-sections.
15736079|NCT04976049|Procedure|Imaging using 5-Aminolevulinic Acid (5-ALA) during surgery|Patients will be administered FDA approved oral 5-ALA and imaged by a FDA approved surgical fluorescence imaging device (Spy Elite) which is 0.5 meter away from the subject.
15736080|NCT04976036|Drug|Nintedanib|150 mg oral nintedanib soft caps, once a day for 2 weeks and twice a day for 10 weeks (12 hours interval)
15736081|NCT04976036|Drug|Placebo|150 mg oral placebo soft caps, once a day for 2 weeks and twice a day for 10 weeks (12 hours interval)
15736082|NCT04976023|Drug|Yupingfeng Powder granules|14.5 5 g twice daily for 8 weeks
15736083|NCT04976023|Other|Placebo|14.5 5 g twice daily for 8 weeks
15736084|NCT04976010|Other|No intervention|There will be no intervention in the separate goups, as this is an observational study
15736091|NCT04975984|Diagnostic Test|qualitative hCG levels and ultrasound criteria|detect upper limit of qualitative hCG levels associated with successful expectant management of ectopic pregnancy
15736092|NCT04975971|Drug|Dextenza 0.4Mg Ophthalmic Insert|DEXTENZA is a corticosteroid intracanalicular insert placed in the punctum, a natural opening in the eye lid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives.
15736093|NCT04975958|Drug|AN2025|oral administration
15736094|NCT04975958|Drug|AN0025|oral administration
15736095|NCT04975958|Drug|Atezolizumab 1200 mg in 20 ML Injection|infusion
15736096|NCT04975945|Drug|Ceftriaxone Sodium|Intravenous vs local action
15736097|NCT04975932|Other|TACE+ICIs|TACE plus ICIs ( with or without molecular targeted therapies)
15736098|NCT04975932|Procedure|TACE|TACE without combination of ICIs ( with or without molecular targeted therapies)
15736099|NCT04975919|Drug|Decitabine and Cedazuridine|Given PO
15736100|NCT04975919|Drug|Venetoclax|Given PO
15736101|NCT04975893|Biological|mRNA-1647|No investigational product will be administered in this extension study.
15736102|NCT04975880|Device|SC+ Hemodialysis System|Following the in-clinic training phase and one week transition, the intervention of self or care partner hemodialysis delivered in the home setting will occur for 8 weeks.
15736103|NCT04975867|Other|Targeted therapeutic hypothermia|Targeted therapeutic hypothermia is then performed at a body temperature of 33±0.5 °C during 24 h using a surface cooling device as soon as possible after the HBO and research consent. After TH ended, rewarming is done slowly between 0.2℃ - 0.5℃/h for 12 hours. After rewarming, it will be held at 36.5 ℃ for 36 hours.
15736104|NCT04975867|Other|Targeted therapeutic normothermia|Targeted therapeutic normothermia will be held at 36.5±0.5 ℃ for 72 hours using a surface cooling device after the HBO and research consent.
15736129|NCT04975659|Behavioral|Placebo and Nocebo effect|Positive suggestion and words is used on Placebo group Negative suggestion and words is used on Nocebo group
15736105|NCT04975854|Behavioral|Exposure Therapy (Virtual Reality)|Virtual reality scenarios consists of increasingly intense exposures to phobic stimuli (e.g., looking over railings from various floor levels) with the support of the therapist. The goal of VRET is sufficient reduction in anxiety to allow the patients to expose themselves to heights in everyday situations.
15736106|NCT04975854|Other|Information Session|This includes 20-minute information session about general principles of exposure therapy before the start of the study.
15736107|NCT04975841|Device|Adipose Derived Regenerative Cells|"The Cytori Celution technology is an automated version of the process and techniques used in the research laboratory to isolate regenerative cells from adipose tissue. The Cytori Celution System uses a proteolytic enzyme blend (Celase) to disrupt the adipose tissue matrix and release the entrapped adipose derived regenerative cells (ADRCs), also referred to in the literature as stromal vascular fraction cells. Once digested, the digestate is separated into fractions (buoyant adipocytes (fat cells) and pelleted ADRCs) by centrifugation. The non-buoyant cell pellet (ADRCs) is then washed and centrifuged through several cycles to remove residual enzyme reagent and cellular debris. Although the Cytori Celution technology replicates known laboratory techniques, it offers significant improvements to the manual laboratory technique by controlling the processing in a closed system that has been validated for safety, performance, and reproducibility."
15736108|NCT04975828|Diagnostic Test|albumin creatinine ratio -EGFR-fundus examination- coronary angiography.|albumin creatinine ratio and EGFR to assess. diabetic nephropathy. fundus examination to assess. diabetic retinopathy. assess of coronary artery disease by coronary angiography. assess diabetic nephropathy by neurologic examination.
15736109|NCT04975802|Other|Placebo|10 oz (296 ml) cherry flavored still beverage
15736110|NCT04975802|Dietary Supplement|Coffeeberry|10 oz (296 ml) cherry flavored still beverage
15736111|NCT04975802|Dietary Supplement|Caffeine|10 oz (296 ml) cherry flavored still beverage
15736112|NCT04975789|Other|InfoViz|The pain InfoViz tool is a two-page paper tool that consists of an explanation of how to use the tool in both Hmong and English, a culturally-appropriate Faces pain severity scale, pain body diagram, and 13 pain qualities in the form of icons representing each pain quality metaphor. The interpreter explains the instructions in Hmong, then marks the body areas corresponding to the location of pain reported by the participant, and marks the pain qualities expressed by the metaphors selected by the Hmong patient. In the clinic appointment, the interpreter communicates to the physician, in English, the pain location and qualities identified by the participant, using the medical terms identified on the InfoViz tool.
15736113|NCT04975776|Behavioral|Sleep restriction therapy|The intervention includes psychoeducation and sleep restriction therapy, sleep restriction instructions, problem-solving, and support for participants in adjusting sleep restriction instructions to their individual needs and life circumstances. At the final session, participants create an individual plan for maintaining new sleep habits and coping with insomnia relapse. During the intervention, participants are free to seek and receive standard care for insomnia.
15736114|NCT04975776|Behavioral|Sleep hygiene|The control condition will include written, general information about sleep and lifestyle and environmental factors that could improve or disturb sleep. The participants will be free to seek and receive standard care for insomnia.
15736115|NCT04975763|Other|Soybean Oil Foods|Three food product containing 10g of soybean oil each will be consumed each day for a today of 30g of soybean oil consumed each day
15736116|NCT04975763|Other|Palm Oil Foods|Three food product containing 10g of palm oil each will be consumed each day for a today of 30g of palm oil consumed each day
15736117|NCT04975750|Behavioral|Problem solving intervention|The intervention focuses on the individual employee and his/her work situation and work-private life balance. The following steps are implemented: inventory and prioritization of problems; brainstorming options and solutions; formulation of an action plan; evaluation, and follow-up. The intervention is carried out in about 3 planned meetings (30 - 45 min) between the manager and the employee. However, given the lack of research regarding the intervention delivered to this specific population and which dose that should be considered as beneficial as well as the complexities of the identified problems, the number of meetings is not specified
15736118|NCT04975750|Behavioral|Care as usual|The managers and the employee have meetings regarding the employee and his/her work situation and work-private life balance. However, the managers are not educated in and do not use the problem solving intervention. They are instead instructed to use their usual procedures.
15736119|NCT04975737|Biological|GamTBvac|The subunit recombinant tuberculosis vaccine GamTBvac (lyophilisate for preparation of solution for subcutaneous administration, 5.35 mg / dose)
15736120|NCT04975737|Biological|Placebo|Placebo for subcutaneous administration
15736121|NCT04975724|Drug|Liposom Forte|Liposom Forte 28mg/2ml solution for injection contains a mixture of purified hypothalamic phospholipids (PLs) from swine brains. The key components of the phospholipid mixture are phosphatidylcholine (PC), phosphatidylethanolamine (PE) and phosphatidylserine (PS).
15736122|NCT04975724|Drug|Citalopram|The medicinal product Citalopram Aurobindo contains citalopram as active ingredient available on the market in 20 mg film coated tablets. The tablets are divisible in two equal part of 10 mg as reported in the SmPC
15736123|NCT04975711|Drug|HIP2105|Test drug
15736124|NCT04975711|Drug|RLD2104|Reference drug
15736125|NCT04975698|Drug|Busulfan|Busulfan dose will be 3.2 mg/kg administered as a single daily dose IV on days -8 through -5 with dosing adjusted using targeted pharmacokinetics.
15736126|NCT04975685|Behavioral|SMART|SMART (Strengthening Mental Abilities Through Relational Training) is a web-based cognitive training program that directly trains 'relational skills' - skills necessary to understand how concepts relate to one another, which underpin complex cognition.
15736127|NCT04975685|Behavioral|Sham brain training (Sudoku)|Sudoku was selected to control for expectancy effects based on popular conceptions that it broadly improves cognitive functions, coupled with little evidence supporting this notion, and its use as an active control in similar trials.
15736130|NCT04975646|Behavioral|Prescribed exercise program|Active or passive exercises for the spastic upper limb, including functional electrical stimulation (FES), performed regularly for two weeks.
15736131|NCT04975633|Device|Bodyport Cardiac Scale|Patients will be instructed to take daily measurements for 90 days. Data will be transmitted to Bodyport and concerning findings (weight gain, change of impedance, elevated heart rate) will be repoted back to the medical team. The medical team with either choose to act on the information given or contine to observe trends. Interventions may include titration of therapy, change in therapy, fluid restriction, sodium restriction or lifestyle modification
15736132|NCT04975620|Device|Fine needle biopsy|Taking biopsy from solid pancreatobiliary mass lesions with 8 back and forth movement of the needle within the lesion with slow withdrawal of the stylet
15736134|NCT04975581|Biological|Allograft Patch|Rotator Cuff repair with Allograft Patch (Graftjacket Now)
15736135|NCT04975568|Other|App and face-to-face physical therapy|Patients will use an app with health tests, general information about the study, personalized HTEP based in McGill's Program after their evaluations, and several online materials related with healthcare and healthy habits linked to social media sites. During the app used they will have 6 face-to-face sessions in 6 people groups with a physical Therapist in a 3 months period
15736136|NCT04975568|Other|App physical therapy|Patients will use an app with health tests, general information about the study, personalized HTEP based in McGill's Program after their evaluations, and several online materials related with healthcare and healthy habits linked to social media sites.
15736137|NCT04975555|Drug|Siltuximab|Siltuximab is administered at the dose of 11mg/kg via intravenous infusion over 1 hour. If no resolution of CRS is achieved then a repeat dose of siltuximab at the dose of 11mg/kg via intravenous infusion over 1 hour will be given.
15736138|NCT04975542|Other|Osteopathic Manipulative Medicine|Manipulative therapies based on Osteopathic principles.
15736139|NCT04975542|Other|Sham|Light touch techniques to mimic to osteopathic treatment.
15736140|NCT04975529|Behavioral|Game on Philly: Engaging Underserved Middle School Youth in Out-of- School Time Sports and Nutrition Education|Two-group quasi experimental intervention with schools assigned to intervention or comparison.
15736141|NCT04975516|Drug|Chemotherapy|Given chemotherapy
15736142|NCT04975516|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15736143|NCT04975503|Other|Observing cardiovascular risk factors|Documenting the presence or absence of CVD risk factors in each participant.
15736144|NCT04975477|Procedure|Esophagogasrtoduodendoscopy and liver stiffness|Time frame between elastography measurement and esophagogastroduodendoscopy is within 6 months.
15736145|NCT04975477|Procedure|hepatic venous pressure gradient|A method was used to evaluate portal pressure.
15736146|NCT04975451|Drug|Anlotinib|Anlotinib plus DCb
15736147|NCT04975438|Drug|GSK1070806|GSK1070806 will be administered
15736148|NCT04975438|Drug|Placebo|Placebo will be administered
15736149|NCT04975425|Diagnostic Test|Fractional Flow Reserve|Comparison between FFR and NHPR before and after guiding catheter disengagement
15736150|NCT04975412|Diagnostic Test|Whole blood zinc level|whole blood zinc levels determined through ashing acid digestion-inductively coupled plasma (ICP) using Shimadzu ICPS-7510, an inductively coupled plasma emission spectrometer.
15736152|NCT04975386|Device|Transthoracic echocardiogram|Transthoracic echocardiogram will be performed before the operation and at certain time intervals during the operation.
15736153|NCT04975373|Drug|Intrauterine injection of hyaluronic acid|operative hysteroscopy - as a part of treatment in cases with retained placenta after delivery diagnostic hysteroscopy - as a routine evaluation after removal of placenta
15736154|NCT04975360|Dietary Supplement|Caffeine|The 160 mg caffeine pulsatile-release formulation was manufactured using a drug layering process. Caffeine and the excipients are dispersed in the coating media and then sprayed onto inert microcrystalline cellulose spheres using a fluid bed through a Wurster tube with continuous inlet air that dries the liquid in the dispersion, to obtain various layers consisting of caffeine and release-controlling polymers. The applied release-controlling polymeric system is based on methacrylate copolymers, which control the release of caffeine in pH-dependent and pH-independent manner. The release mechanism of the polymeric system is mainly driven by the swellability and permeability of the copolymers. The final micropellets are then encapsulated into hydroxypropylmethylcellulose capsules.
15736155|NCT04975360|Other|Placebo|Identical hydroxypropylmethylcellulose capsules without containing caffeine micropellets.
15736156|NCT04975347|Drug|kisspeptin 112-121|Six IV doses of kisspeptin 112-121
15736157|NCT04975347|Drug|GnRH|Two IV doses of GnRH
15736158|NCT04975347|Drug|Naloxone|One bolus and one infusion of naloxone
15736159|NCT04975334|Drug|kisspeptin, GnRH, naloxone|Six IV doses of kisspeptin 112-121
15736160|NCT04975334|Drug|GnRH|Two IV doses of GnRH
15736161|NCT04975334|Drug|Naloxone|One bolus and one infusion of naloxone
15736162|NCT04975321|Procedure|Placement of an anterior primary crown restoration with the Nu Smile Zirconia device|Placement of an anterior primary crown restoration
15736166|NCT04975295|Drug|LY3361237|Administered SC
15736167|NCT04975295|Drug|Placebo|Administered SC
15736168|NCT04975282|Device|Bottle feeding|Bottle was used as an alternative oral feeding method for preterm infants.
15736169|NCT04975282|Device|Cup feeding|Cup was used as an alternative oral feeding method for preterm infants.
15736170|NCT04975269|Drug|Acetazolamide|Target dose: 500 mg / day
15736171|NCT04975269|Drug|Placebo|Placebo
15736172|NCT04975256|Drug|MRTX849|KRAS G12C inhibitor
15736173|NCT04975256|Drug|BI 1701963|SOS1 Inhibitor
15736405|NCT04973267|Behavioral|Attention-Matched Control Lifestyle Habits Videos|Web-based videos providing information on sleep hygiene and proper diet.
15736174|NCT04975243|Device|GentleMax Pro Plus 755nm and 1064nm laser system|The GentleMax Pro Plus is a 755nm and 1064nm laser system. The GentleMax Pro PlusTM is indicated for stable long-term or permanent hair reduction using varying spot sizes and fluences.
15736175|NCT04975230|Behavioral|Sleep Self-Management|Intervention delivered by a sleep coach will include 1) initial in-person 50 min consultation; 2) brief 5 min weekly follow ups in a format TBD; and 3) in-person 30 min booster sessions every 3 weeks (total 13 sessions).
15736176|NCT04975217|Procedure|Fecal Microbiota Transplantation|Undergo FMT
15736177|NCT04975217|Drug|Fecal Microbiota Transplantation Capsule|Given PO
15736178|NCT04975217|Other|Questionnaire Administration|Ancillary studies
15736179|NCT04975217|Procedure|Resection|Undergo standard of care resection
15736180|NCT04975217|Procedure|Therapeutic Colonoscopy|Undergo colonoscopy
15736182|NCT04975191|Behavioral|Resources|Participants will be provided a list of resources available at VCU that are intended to support student success
15736183|NCT04975191|Behavioral|Personalized Feedback Program (PFP)|Participants will complete an interactive online program that explores their personality-related traits to provide personalized recommendations for success
15736184|NCT04975191|Behavioral|Substance Use Feedback Program (BMI)|Participants will complete an online program based on brief motivational intervention (BMI) content/principles that explores their current substance use patterns to make personalized recommendations for success
15736185|NCT04975178|Biological|MTBVAC|MTBVAC is a novel TB vaccine candidate based on an attenuated M. tuberculosis clinical isolate of the Euro-American lineage. Attenuation is based on two independent, stable genetic deletions of the genes phoP and fadD26 coding for two major virulence factors, the transcription factor PhoP and the cell-wall lipids PDIM, respectively. We hypothesize that MTBVAC will provide improved protection, as individuals latently infected with live M.tuberculosis have an 80% lower chance of developing TB, and as MTBVAC contains most of the genes deleted from BCG and presents a wider collection of antigens to the host immune system. Preclinical studies in different animal models indicated that MTBVAC is safe and is able to induce an improved protection compared to BCG.
15736186|NCT04975178|Biological|BCG|BCG is a live attenuated M. bovis strain developed 100 years ago and is used as a preventive vaccine against tuberculosis. It is administered at birth.
15736187|NCT04975165|Procedure|Total knee arthroplasty|Bilateral surgery in one arm and staged surgery in another arm during total knee arthroplasty
15736188|NCT04975152|Drug|Cemiplimab-Rwlc|Flat dose of cemiplimab-rwlc 350 mg IV every 3 weeks, up to 9 cycles.
15736189|NCT04975139|Device|RS-fMRI|Advanced imaging method that can identify the spatiotemporal distribution of the intrinsic functional networks within the brain
15736190|NCT04975126|Other|CatInfo tool|Presentation about cataract surgery
15736191|NCT04975113|Other|progressive neuromuscular exercise program|The exercises to be performed in the following week at the beginning of each week were explained by the researcher physiotherapist on the brochure and given as a home program and continued for a total of 12 weeks. The researcher physiotherapist saw the patients every week and carried out exercise compliance and control.
15736192|NCT04975113|Other|Exercise and Taping|"I taping for accurate positioning of the tissue was applied to the patients to neutralize the patellofemoral joint. During the knee flexion in the supine position, the tape was adhered to the skin with a moderate-to-extreme stretch (50%-75%) . Clinical therapeutic applications of the Kinesio taping methods (Tokyo, Japan: Ken Ikai Co Ltd.). In addition to the patellar taping, correction taping to neutralize the subtalar joint by elevating the midtarsal joint and medial arch was applied. The patients were positioned in prone lying and knee flexion position, the taping was started at the 5th metatarsal level on the dorsal side of the finger and finished extending towards the medial of the tibia . Tapings were renewed at the beginning of each week for 6 weeks."
15736195|NCT04975087|Other|Patients group|Patients will complete the mentioned questionnaires.
15736196|NCT04975074|Drug|Iron|One of each type of iron was taken orally according to the instructions and followed every two weeks
15736197|NCT04975061|Drug|YY-20394|YY-20394 is a small molecule inhibitor.
15736198|NCT04975048|Dietary Supplement|Egg yolks|Two egg yolks/day was designed for the study. However, uneven egg sizes during period 1 made the intervention unable to achieve the protocol's recommended cholesterol intake level, and the intervention was modified in period 2 to be 0.8 g egg yolk/day/kg body weight. This dosage was calculated by dividing the 35 g egg yolk with the lightest weight among the volunteers, which was 45 kg. This provides a more consistent cholesterol intake between persons as the egg yolk dosage is standardized for persons with different weights.
15736199|NCT04975048|Dietary Supplement|Macronutrients equivalent control|The macronutrients equivalent control group was served 42 g egg white cooked with 10 g olive oil, designed to best imitate the energy and macronutrients of 35 g egg yolk (energy 119 kcal, protein 5 g, fat 10 g, carbohydrate 1 g) since the average weight of two large egg yolk was presumed to be 35 g. As an egg yolk dose of 0.8 g egg yolk per kg body weight per day was served during the intervention period 2, the macronutrients equivalent control was likewise adjusted as follow: subjects who weighed less than 55 kg were served 51 g egg white cooked with 12 g olive oil, which is equivalent to 40 g egg yolk; those who weighed from 55 kg to 65 kg were served 61 g egg white cooked with 14 g olive oil, which is equivalent to 48 g egg yolk; and those who weighed more than 65 kg were served 71 g egg white cooked with 17 g olive oil, which is equivalent to 56 g egg yolk.
15736200|NCT04975035|Drug|Zolodine|Collect 200 patients who meet the criteria into the group. After enrollment, according to the principle of cross dressing change, the attending physician can decide the dressing change method according to the patient's condition, individual condition and other factors; within 2-4 weeks, the original antipsychotics should be gradually stopped, and Zoladine capsules will be gradually added to the target The dose is 120-160mg/d, orally 1-2 times a day, with meals.
15736201|NCT04975022|Drug|N11005|oral insulin N11005, 300IU, p.o.
15736202|NCT04975022|Drug|Novolin R|reference preparation Novolin R, 0.1 IU/Kg, i.h.
15736406|NCT04973254|Drug|CAB-RPV LA delivered in community settings|Monthly delivery of injectable HIV medication within community-based settings
15736203|NCT04975009|Behavioral|Fear conditioning|Participants will learn to associate neutral stimuli with a mildly uncomfortable electrical stimulation to the wrist. The intensity of the electrical stimulus is calibrated prior to the start of the experiment to a level deemed highly annoying but not painful by the participant.
15736210|NCT04974983|Other|Observation of neurological deficits|Observation of neurological deficits
15736211|NCT04974970|Drug|Peanut Immunotherapy|Treatment will be injected peanut extract every 2 weeks for a period of 3 months.
15736212|NCT04974957|Drug|SHR-1701；BP102|"Drug: SHR-1701 IV infusion
~Drug: BP102 IV infusion"
15736213|NCT04974944|Drug|Camrelizumab|IV injection
15736214|NCT04974944|Drug|Apatinib|Oral
15736215|NCT04974944|Drug|Paclitaxel|IV injection
15736216|NCT04974944|Drug|Cisplatin|IV infusion
15736217|NCT04974944|Drug|Carboplatin|IV infusion
15736218|NCT04974944|Drug|Bevacizumab|IV infusion
15736219|NCT04974931|Device|PREVENA Incision Management System|Eligible participants, i.e. participants meeting inclusive criteria, will be randomised in equal proportions and divided into two arms. The PREVENA dressings will be applied to the
15736220|NCT04974918|Procedure|Facial Artery Perforator-Based Nasolabial Flaps in The Reconstruction of large Lip defects post traumatic or post tumor resection.|A perforator near the defect was selected to accomplish a sufficient arc of rotation without tension. The flap was designed to cover the defect based on one perforator and to hide the donor site in the nasolabial fold. An incision on one side of the flap was made to the subcutaneous tissue. Undermining of the flap until the perforators were identified. After the perforators were identified, the flap was redesigned and an incision was made circumferentially. Dissection of the pedicle was performed until tension-free transposition was done to cover the defect, and the distal perforators were sacrificed to help flap movement.
15736221|NCT04974905|Procedure|retrograde access for re-canalization of infra-inguinal arterial occlusive disease|after failed antegrade approach for re-canalization of infra-inguinal arterial occlusive disease( failed reentry into the distal true lumen), the retrograde approach will be attempted
15736222|NCT04974892|Diagnostic Test|Blood test|Blood tests will be taken at 12, 20, 28 and 36 weeks gestation to assess the immune profile and omic profile.
15736223|NCT04974879|Drug|Osimertinib Oral Tablet|bevacizumab (avastin), intravenously
15736224|NCT04974866|Drug|EGFR-TK Inhibitor|epidermal growth factor receptor tyrosine kinase inhibitors
15736225|NCT04974853|Combination Product|Cardio-complement|Ayurvedic combination of Terminalia Arjuna, Withania Sominifera, Garcinia Cambogia and piperine (as bioenhancer) in pre-specified dosage.
15736226|NCT04974840|Behavioral|Treadmill training combined with/ without thera-band|Treadmill walking training with thera-band Treadmill walking training without thera-band
15736227|NCT04974827|Drug|Camrelizumab|200mg/3weeks
15736228|NCT04974827|Drug|Cisplatin or Carboplatin|Cisplatin (40mg/m²), every week Carboplatin(AUC 2)
15736229|NCT04974814|Drug|Rosuvastatin 40mg|patients in active arms will be preloaded with a single 40 mg rosuvastatin in ER before PCI
15736230|NCT04974814|Drug|Atorvastatin 80mg|patients in active arms will be preloaded with a single 80 mg atorvastatin in ER before PCI
15736231|NCT04974814|Drug|Control Test|patients in control arm will not preloaded with statin in ER before PCI
15736232|NCT04974801|Device|Provox Life|Use of Provox Life range of HMEs for different situations and their attachments (adhesives and laryngectomy tubes)
15736233|NCT04974801|Device|Usual Care|Continued Usual Care routines.
15736234|NCT04974788|Other|Low Intensity Respiratory Muscle Training|Respiratory muscle training will be performed at 30% (low intensity) of the maximum inspiratory pressure, which indicates respiratory muscle strength. The training will consist of 2 sessions in total; Each session will last 15 minutes. There will be a break of at least 30 minutes between training sessions.
15736235|NCT04974788|Other|Medium Intensity Respiratory Muscle Training|Respiratory muscle training will be performed at 60% (medium intensity) of the maximum inspiratory pressure, which indicates respiratory muscle strength. The training will consist of 2 sessions in total; Each session will last 15 minutes. There will be a break of at least 30 minutes between training sessions.
15736236|NCT04974788|Other|High Intensity Respiratory Muscle Training|Respiratory muscle training will be performed at 80% (high intensity) of the maximum inspiratory pressure, which indicates respiratory muscle strength. The training will consist of 2 sessions in total; Each session will last 15 minutes. There will be a break of at least 30 minutes between training sessions.
15736237|NCT04974775|Diagnostic Test|Blood collection|Sampling on admission to ICU (all patients)
15736238|NCT04974775|Diagnostic Test|Blood collection, serial sampling|"Additional sampling to admission samples in
~the Cardiac Arrest group after 12 and 48 hours
~the Covid-19 group on day 2 and 7 while in the ICU
~the Covid-19 group after 3 and 12 months."
15736239|NCT04974762|Procedure|Wound infiltration|Surgical wound infiltration by proceduralist
15736240|NCT04974762|Procedure|Truncal blocks|Truncal blocks provided by anesthesiology team for device placement
15736241|NCT04974749|Biological|REPLAGAL|Participants will receive REPLAGAL infusion intravenously.
15736242|NCT04974736|Behavioral|iEHR + Navigator|"The iEHR + Navigator intervention consists of an iEHR part of the intervention in the pediatric primary care setting which will include routine screening of families for tobacco use and treatment delivery to parents who smoke and will be linked to the child's electronic health record.
~The enrolled parents will also be offered support from Community Health Navigators, who will work with offices to provide customized cessation support to tobacco users, ensuring access to medications and services."
15736243|NCT04974723|Drug|Abaloparatide|Abaloparatide subcutaneous (abaloparatide SC [ABL]; Tymlos®)
15736244|NCT04974723|Drug|Teriparatide|Teriparatide subcutaneous (TPTD; Forteo®)
15736245|NCT04974710|Diagnostic Test|Outpatient MRI|All participants will undergo a standardised imaging protocol in a MRI scanner. This will take place during the same visit or following the transvaginal ultrasound (TVUS) and in advance of any surgical procedure (laparoscopy).
15736246|NCT04974684|Device|HeartMate 3|Patients implanted with HeartMate 3 will be randomized in 2:1 ratio in interventional and control group. Patients in interventional group will be switched to therapy with apixaban instead of warfarin.
15736247|NCT04974684|Drug|Apixaban|Patients implanted with HeartMate 3 will be randomized in 2:1 ratio in interventional and control group. Patients in interventional group will be switched to therapy with apixaban instead of warfarin.
15736248|NCT04974671|Radiation|Stereotactic Body Radiation Therapy|1-5 fraction Stereotactic Body Radiation Therapy to all sites of progression
15736249|NCT04974658|Procedure|Inter-semispinal plane block|Ultrasound Inter-semispinal plane block
15736252|NCT04974632|Procedure|localization|small, deep or ground-glass opacity (GGO) lung tumor, Mobile 3D C-arm CT assisted pre-operative localization, video-assisted thoracic surgery(VATS)
15736253|NCT04974619|Behavioral|Online survey|Aim 1 Participants will be asked to complete an online survey to identify knowledge gaps, health beliefs, attitudes, and educational learning preferences in this high-risk population.
15736254|NCT04974619|Behavioral|Interviews|In-depth individual interviews will be conducted with key healthcare stakeholders (i.e.,healthcare clinical leadership, providers and staff, community-based organization staff) to inform educational intervention content and delivery methods and potential facilitators and barriers to implementation of the educational intervention.
15736255|NCT04974619|Behavioral|Focus groups|Focus groups will be conducted in-person or remotely to evaluate the newly created educational materials about HPV vaccination. 4-6 focus groups with 24 young Latino men who have sex with men (YLMSM) (12 in each site) will be conducted to obtain feedback on the intervention, using an iterative process, whereby researchers conduct 1 focus group in FL and a complementary focus group in Puerto Rico and then revise the content based upon feedback from those focus groups, prior to proceeding to the next round of focus groups.
15736256|NCT04974606|Dietary Supplement|Cherry-flavored still beverage|10 oz bottle
15736257|NCT04974606|Other|Placebo cherry-flavored still beverage|10 oz bottle
15736258|NCT04974593|Other|low fat diet|A trained dietitian will provide instruction of the LFD according to standard practice.
15736259|NCT04974580|Drug|Nicotine patch|NRT will be discussed and dosed by the study quit coach during coaching calls per quitline dosing protocols. NRT treatment will consist of up to an 8 week supply of nicotine patch, gum, and/or lozenge. NRT will be sent in two 4 week shipments. Participants may be dosed for a single form of NRT or combination NRT (patch plus gum or lozenge) based on coach assessment of nicotine use and participant preference.
15736260|NCT04974580|Behavioral|Phone Counseling|Participants in all four arms of the study will receive two proactive phone-based behavioral coaching calls for quitting vaping, which will include making a quit plan, learning to cope with urges to vape, and education on strategies for quitting and staying quit. Calls utilize the quitline evidence-based protocol. The first call lasts approximately 20 minutes, the second calls lasts approximately 10 minutes, and participants are encouraged to call in for ad hoc calls if they would like additional support.
15736261|NCT04974580|Behavioral|Digital Coaching|Intervention descriptionText-based vaping cessation program that utilizes evidence-based content from the quitline tobacco cessation protocol, as well as links directing participants to additional online educational content (brief videos, audio content, quizzes, and educational activities).
15736262|NCT04974567|Other|Melody®|Melody® is a tear-based screening assay for breast cancer developed and validated by Namida Lab, Inc., a high complexity CLIA certified lab. Melody® consists of two parts: tear sample collection and clinical lab test. Melody® is a high-complexity lab-developed test for breast cancer screening.
15736263|NCT04974554|Behavioral|FIT|FIT Families is a home-based intervention that works with youth and caregivers to lose weight and improve their health. The intervention lasts 6 months. Sessions are held twice a week for the first 3 months and then once a week for the second 3 months. These sessions will take place in home with a community health worker. In addition, participants will have the opportunity to earn prizes for completing certain intervention related tasks.
15736264|NCT04974554|Behavioral|Home-Based Family Support|Home-Based Family Support Group will receive six months of weekly family counseling in the home. The weekly visits have 3 goals: 1) provide basic education in nutrition and physical recommendations for adolescent and adult obesity; 2) assess and monitor weight, physical activity, and diet via logs; and 3) offer opportunities to discuss barriers they identify to adherence to weight loss recommendations. The HBFS CHW will also address non-weight related problems such as peer or family relationship problems during the visits.
15736265|NCT04974541|Other|Heart Health Yoga|Yoga-based digital intervention
15736266|NCT04974541|Other|Psychosocial education|Standard psychosocial education component
15736270|NCT04974515|Device|eXciteOSA|eXciteOSA is a device for improving genioglossus endurance through electrical stimulation
15736271|NCT04974502|Procedure|Nonsurgical periodontal treatment|Oral hygiene instructions, scaling and root planning.
15736277|NCT04974450|Dietary Supplement|Trigona honey|composition : vitamin C 0.15%, Protein 1.32%, lipid 0.23%, carbohydrate 64.12%, beta carotene 10.61 ppm, Calcium 273,23, magnesium 338.94, zinc 12.49 ppm, and acidity 5.76. Total polyphenol 133.52 ppm, total flavonoid 159.62 ppm. This liquid has a sour profile
15736278|NCT04974450|Dietary Supplement|control|Artificial honey with fructose, Glucose, pure honey (2,271%), citric acid, and lime extract (0,076%).
15736279|NCT04974411|Other|infection|this study had two observation cohorts, one that observed sepsis in the presence of infection; the other cohort was monitored during sepsis until septic shock appeared
15736280|NCT04974411|Other|sepsis|this study had two observation cohorts, one that observed sepsis in the presence of infection; the other cohort was monitored during sepsis until septic shock appeared
15736281|NCT04974398|Drug|Penpulimab|Group A: Penpulimab (200 mg, administered on Day 1 of each cycle, Q3W) + cisplatin (80 mg/m2, administered on Day 1 of each cycle, Q3W, up to 6 cycles) + gemcitabine (1000 mg/ m2, administered on Days 1 and 8 of each cycle, Q3W, up to 6 cycles), 3 weeks (21 days) per treatment cycle. Afterward, penpulimab will be used for maintenance treatment (200 mg, administered on Day 1 of each cycle, Q3W).
15736282|NCT04974398|Drug|placebo|Group B: Placebo (200 mg, administered on Day 1 of each cycle, Q3W) + cisplatin (80 mg/m2, administered on Day 1 of each cycle, Q3W, up to 6 cycles) + gemcitabine (1000 mg/m2, on Days 1 and 8 of each cycle, Q3W, up to 6 cycles), every 3 weeks (21 days) per treatment cycle. Afterward, a placebo will be used for maintenance treatment (200 mg, administered on Day 1 of each cycle, Q3W).
15736283|NCT04974385|Drug|Liposomal bupivacaine|Validate the analgesic efficacy of admixed LB + bupivacaine compared with plain bupivacaine when injected for ISNB for total shoulder arthroplasty.
15736284|NCT04974385|Drug|Bupivacaine|Active comparator as standard of care.
15736285|NCT04974359|Drug|Lu AG06466|Lu AG06466 - capsules
15736286|NCT04974359|Drug|Placebo|Placebo - capsules
15736287|NCT04974346|Radiation|Paraaortic prophylactic irradiation and pelvic definitive concurrent chemoradiation|The para-aortic area, from left renal vein level to abdominal aorta bifurcation level，will be prophylactic irradiation. The other intervention is the same as control arm.
15736288|NCT04974346|Radiation|Pelvic definitive concurrent chemoradiation|Pelvic definitive concurrent chemoradiation, including external beam radiotherapy, concurrent chemotherapy and brachytherapy.
15736289|NCT04974333|Device|Mobile health application on phone|Patients will use a mobile app on their smart phones
15736290|NCT04974320|Biological|blood biomarkers|All patients were obtained blood biomarkers: troponin, ST2, copeptin
15736291|NCT04974307|Device|OrCam MyEye 2|The study uses the OrCam MyEye 2, a 22.5-g portable, eyeglass-mounted device that converts camera-captured inputs to auditory outputs. Its advertised functions include text reading, facial recognition, and product identification. The study participants and parents/guardians will be trained on how to use the device. Evaluations for primary and secondary endpoints will be done following 1 week and 1 month of device use.
15736292|NCT04974294|Biological|PPV23|random allocation 1:1:1 IM injection
15736293|NCT04974294|Biological|PCV13|random allocation 1:1:1 IM injection
15736294|NCT04974294|Other|Saline for injection|random allocation 1:1:1 IM injection
15736295|NCT04974281|Combination Product|PD-1 and Lenvatinib Plus TACE|PD-1 Antibody and Lenvatinib Plus Transarterial chemoembolization(TACE )： Patients were recommended to receive TACE once every 6 weeks. Patients were recommended to begin oral administration of Lenvatinib 3 days after the first TACE treatment, and meanwhile to start intravenous drip of PD-1 antibody 3 days after the first TACE treatment, once every 3 weeks.
15736296|NCT04974268|Other|Specific supervised exercise and weight loss program|Intervention group that receives supervised exercise and weight loss program based on individual and group intervention with Mediterranean diet and substitute for a daily meal, manual lymphatic drainage and compression garment if there is more than 600 ml of excess volume in the limb affected.
15736297|NCT04974255|Other|Measuring of fibrosis in thyroid specimen and measuring of Anti-tTG in serum samples|Examination of pathology specimen and laboratory measuring
15736298|NCT04974242|Other|Physiotherapist-led exercise|A programme of physiotherapist-led exercise over approximately 12 weeks.
15736299|NCT04974229|Other|In line with the Dutch guideline for non-specific low back pain, Standard usual care for non-specific low back pain was applied.|In line with the Dutch guideline for non-specific low back pain, Standard usual care or non-specific low back pain was applied.
15736300|NCT04974216|Drug|Tafasitamab|Administration : IV at 12mg/Kg C1 to C3: D1, D8, D15, D22 C4 to C6: D1, D15 C7 to C12: D1
15736301|NCT04974216|Drug|Lenalidomide|Oral administration: hard capsule C1 to C6: 20mg/day C7 to C12: 15mg/day
15736302|NCT04974216|Drug|Rituximab|Administration: IV at 375mg/m2 C1 to C6: D1
15736303|NCT04974203|Device|AptameX|DNA aptamer-based test using patient's saliva
15736304|NCT04974190|Device|Nasal Spray Device|A Nasal Spray apparatus containing a liquid
15736306|NCT04974151|Drug|Amlodipine besylate tablets|The amlodipine used in this study is a listed product. All drugs used in the Randomized Treatment Period of this study will be packed into bottles with the same outer appearance and corresponding labels of the clinical trial (100 tablets/bottle).
15736307|NCT04974151|Drug|Amlodipine besylate And Folic Acid Tablets|The amlodipine besylate and folic acid tablets have been approved for listing by the China Food and Drug Administration, approval number: Zhunzi H20180020. All drugs used in the Randomized Treatment Period of this study will be packed into bottles with the same outer appearance and corresponding labels of the clinical trial (100 tablets/bottle).
15736486|NCT04972552|Other|Watermelon diet|Participants will be asked to eat watermelon at a minimum of one meal per day 3-5 days a week
15736308|NCT04974151|Drug|Folic Acid Tablets|The folic acid used in this study is a listed product. All drugs used in the Randomized Treatment Period of this study will be packed into bottles with the same outer appearance and corresponding labels of the clinical trial (0.4mg/tablet, 200 tablets/bottle).
15736309|NCT04974138|Drug|Amlodipine besylate tablets|The amlodipine used in this study is a listed product. All drugs used in the Randomized Treatment Period of this study will be packed into bottles with the same outer appearance and corresponding labels of the clinical trial (100 tablets/bottle).
15736310|NCT04974138|Drug|Amlodipine besylate and folic acid tablets|The amlodipine besylate and folic acid tablets have been approved for listing by the China Food and Drug Administration, approval number: Zhunzi H20180020. All drugs used in the Randomized Treatment Period of this study will be packed into bottles with the same outer appearance and corresponding labels of the clinical trial (100 tablets/bottle).
15736311|NCT04974125|Procedure|Drain|A 10 mm suction drain is placed through a trocar in the right hypochondrium (liver).
15736312|NCT04974125|Procedure|Manual exsufflation|Exsufflation through the trocar opening.
15736313|NCT04974112|Other|Apply SGA and NRS2002|Special researchers appointed by the research unit apply SGA and NRS2002 and other data measurement tools to collect patient information
15736315|NCT04974086|Other|Sexual and reproductive health (SRH) services|The intervention, called the SRH services CDS tool, includes integrating sexual and reproductive health guideline prompts into the electronic health record (EHR). The prompt guides clinicians to assess and broadly respond to adolescents' SRH behaviors through EHR survey data. Through the CDS tool, clinicians will be prompted to provide comprehensive and evidence-based sexual health care for teens including, for example: providing patient-facing education about sexual preventative health topics; facilitating clinician decision-making regarding and prescription of contraception or human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP); facilitating ordering of HIV and sexually transmitted infection (STI) laboratory tests to improve both risk-based and routine annual preventative screening; linking youth to health preventative services such as PrEP navigators or sexual health educators; and providing external referrals to adolescents, if needed.
15736316|NCT04974073|Drug|PHY606|Danggui Buxue Tang is a well-known TCM formula indicated for anemia through immune modulation and increase energy metabolism
15736317|NCT04974060|Drug|Remifentanil Injection|Dilute 2mg Remifentanil with normal saline to 50 ml (40ug/ml) and continuously intravenous infused at the doses of 0.02, 0.04, 0.06, and 0.08 μg/kg/min for each lasting 30 minutes.
15736318|NCT04974047|Drug|Tislelizumab|Administered intravenously as specified in the treatment arm.
15736319|NCT04974021|Drug|Ferric carboxymaltose|Intravenous ferric carboxymaltose for the treatment of iron deficiency in HFrEF as per 2016 European Society of Cardiology Heart Failure guidelines.
15736320|NCT04974008|Drug|OST31-164|Patients who will receive OST31-164 as a single agent every 3 weeks for 48 weeks with 4 doses constituting 1 treatment cycle (12 weeks per cycle). Each patient will receive treatment at a dose of 1x109 CFU until week 48 or until disease progression, unacceptable toxicity, or the patient meets any other treatment discontinuation criteria.
15736321|NCT04973995|Behavioral|several physical examinations|By using physical examinations, the incidence of these physical examinations corresponding to shoulder muscls injury
15736322|NCT04973982|Drug|Envarsus|3 month treatment, given once daily, oral tablet. Dose titrated according to levels target 6-10ng/ml
15736323|NCT04973982|Drug|Adoport|3 month treatment, given twice daily, oral tablet. Dose titrated according to levels target 6-10ng/ml
15736324|NCT04973969|Other|Decapeptyl|diagnosis of predictio value
15736325|NCT04973956|Other|Relaxation|This group will perform the APMR. This intervention consists of a standardized 20 min session in which subjects are asked to sequentially tense and relax various muscle groups. To do so, participants will listen to an audio with relaxation instructions while seated in a reclining seat and dimmed lighting.
15736326|NCT04973956|Other|Control|This group will perform the control intervention, in which the participants will listen to a content-neutral audio for 20 minutes and will be seated in an un-reclined chair with normal lighting.
15736327|NCT04973943|Diagnostic Test|Donor-derived cell Free DNA|Measurement of dd-cfDNA and comparison against grade of rejection as determined by endomyocardial biopsy, taken simultaneously
15736328|NCT04973930|Behavioral|Interpersonal Psychotherapy|Time-limited, affect-focused, empirically supported psychotherapy
15736329|NCT04973930|Drug|Venlafaxine HCl ER|FDA-approved antidepressant medications
15736330|NCT04973917|Procedure|respiratory support|respirators for invasive mechanical ventilation
15736331|NCT04973904|Drug|Toripalimab|IV infusion
15736332|NCT04973904|Drug|Paclitaxel|IV infusion
15736333|NCT04973904|Drug|Cisplatin|IV infusion
15736334|NCT04973904|Drug|Bevacizumab|IV infusion
15736336|NCT04973878|Procedure|EGD first|In this group, patients receiving an EGD followed by a colonoscopy during a same-day bidirectional endoscopy. Patients receive deep sedation with propofol and fentanyl.
15736337|NCT04973878|Procedure|Colonoscopy first|In this group, patients receiving a colonoscopy followed by EGD during a same-day bidirectional endoscopy. Patients receive deep sedation with propofol and fentanyl.
15736338|NCT04973865|Other|Validation & reliability|Translated version of IPAQ(SF) validation & Reliability
15736339|NCT04973852|Device|Ekso|Exoskeleton walking
15736340|NCT04973839|Behavioral|Video optimizing expectations before PMR (unguided) + Progressive Muscle Relaxation (PMR)|Participants watch a video aiming to optimize participants' expectations before undergoing a single PMR session without personal support of the experimenter (unguided). The PMR session involves learning to monitor tension in each specific muscle group in the body by deliberately inducing tension in each group. This tension is then released, with attention paid to the contrast between tension and relaxation.
15736372|NCT04973605|Drug|BGB-11417 + Dexamethasone + Carfilzomib|BGB-11417 orally at recommended dose in combination with dexamethasone or dexamethasone and carfilzomib intravenously
15736341|NCT04973839|Behavioral|Video optimizing expectations before PMR (guided) + Progressive Muscle Relaxation (PMR)|Participants watch a video aiming to optimize participants' expectations before undergoing a single PMR session with the personal support of the experimenter (guided). The PMR session involves learning to monitor tension in each specific muscle group in the body by deliberately inducing tension in each group. This tension is then released, with attention paid to the contrast between tension and relaxation.
15736342|NCT04973839|Behavioral|Neutral video before PMR (unguided) + Progressive Muscle Relaxation (PMR)|Participants watch a neutral video (not aiming to optimize participants' expectations) before undergoing a single PMR session without personal support of the experimenter (unguided). The PMR session involves learning to monitor tension in each specific muscle group in the body by deliberately inducing tension in each group. This tension is then released, with attention paid to the contrast between tension and relaxation.
15736343|NCT04973839|Behavioral|Neutral video before PMR (guided)+ Progressive Muscle Relaxation (PMR)|Participants watch a neutral video (not aiming to optimize participants' expectations) before undergoing a single PMR session with the personal support of the experimenter (guided).The PMR session involves learning to monitor tension in each specific muscle group in the body by deliberately inducing tension in each group. This tension is then released, with attention paid to the contrast between tension and relaxation.
15736344|NCT04973826|Drug|Aztreonam-Avibactam|500/167 mg ATM/AVI loading infusion, followed by 1500/500 mg ATM/AVI extended loading infusion, then 1500/500 mg ATM/AVI maintenance dose infusion every 6 hours
15736345|NCT04973813|Behavioral|Guideline + Active Choice + action&coping planning (GA+)|Web-based intervention consisting of information and assignments, including: completing a decision balance sheet; indicating the importance of personal values and the time, effort and energy spent on these personal values; action planning; identifying barriers to physical activity; coping planning
15736346|NCT04973813|Behavioral|Guideline + Active Choice (GA)|Web-based intervention consisting of information and several assignments, including: completing a decision balance sheet; indicating the importance of personal values and the time, effort and energy spent on these personal values; identifying barriers to physical activity.
15736347|NCT04973813|Behavioral|Guideline + information (GI)|Web-based information about the national physical activity guideline, pros and cons of physical activity, and possible barriers to physical activity.
15736348|NCT04973813|Behavioral|Guideline (G)|Web-based information about the national physical activity guideline.
15736349|NCT04973800|Drug|Simvastatin 20mg|Simvastatin 20mg ON PO for 28-30 days
15736350|NCT04973800|Drug|Placebo|Sucrose placebo ON PO for 28-30 days
15736351|NCT04973787|Biological|biological disease-modifying antirheumatic drugs (bDMARDs)|bDMARD therapy (TNF inhibitors), according to the Portuguese recommendations for the use of biological therapies in patients with axSpA and RA
15736352|NCT04973761|Other|Zirconium crowns|Prefabricated pirmary anteroir teeth zirconium crowns
15736353|NCT04973761|Other|Strip composite crowns|Strip composite crowns
15736354|NCT04973748|Behavioral|Open Label Conditioning|a. Conditioning therapy in OLC group: Patients in the OLC group will receive conditioning therapy with all doses of opioids and placebo. Placebo will be formulated to have the same physical appearance as liquid oxycodone and will be dispensed by the Weinberg inpatient pharmacy and administered by the nursing staff. Given reduced sense of smell and taste and administration of medications via nasogastric or gastric tube, taste of the medication will not be a consideration for formulation of placebo. At all times that oxycodone or placebo medication is administered, the patient will undergo conditioning therapy. As described here, the patient will 1) be given time to note the similar color and appearance of the medications and 2) be given simultaneous exposure to a clove oil Sniffin' sticks, which has been shown to stimulate both olfactory and trigeminal chemoreceptors.
15736355|NCT04973735|Drug|LY-CovMab|single IV infusion
15736356|NCT04973722|Drug|LY06006|60 mg/1 ml, once every 6 months administered subcutaneously
15736357|NCT04973722|Drug|Prolia|60 mg/1 ml, once every 6 months administered subcutaneously
15736358|NCT04973709|Diagnostic Test|Confussion assessment method (CAM)|Participants enrolled in the Delirium group according to the CAM.
15736359|NCT04973709|Diagnostic Test|Dementia diagnosis|Participants enrolled in the Dementia group according to the CDR scores and MMSE scores and DSM4/5 criteria
15736360|NCT04973696|Behavioral|Toolkit for Optimal Recovery after Orthopedic Injury|The Toolkit (TOR) is a 4-session, individual, live video, synchronous program developed specifically for patients with orthopedic acute injuries who are at risk for chronic pain and disability. The program teaches evidence-based mind-body skills (e.g., relaxation and mindfulness; myths about pain; activity pacing; acceptance and values based goal setting). Participants gain access to a website downloaded on their phones as an app. The website included explainer videos of skills and recordings of mindfulness and relaxation exercises. In addition, participants will receive usual care as determined by medical team.
15736361|NCT04973696|Other|Minimally Enhanced Usual Care (MEUC)|The MEUC is educational material, in the form of a physical hard-copy pamphlet and website downloaded as an app on their phones. In addition, participants will receive usual care as determined by medical team.
15736362|NCT04973683|Drug|AL101|Given IV
15736363|NCT04973683|Procedure|Therapeutic Conventional Surgery|Undergo standard of care surgery
15736364|NCT04973670|Drug|Sivelestat sodium|Sivelestat sodium 0.2mg/kg.h for at least 48h
15736365|NCT04973670|Drug|Placebo|The same amount of NS containing only sivelestat sodium excipients
15736366|NCT04973657|Drug|VK0214|API in capsule
15736367|NCT04973657|Other|Placebo|API in capsule
15736368|NCT04973644|Device|Remote monitoring devices+Internet management platform|Remote monitoring devices collects blood glucose, total cholesterol, serum ketones and serum uric acid,then upload data to the platform.
15736369|NCT04973631|Genetic|Sex, Age|Evaluate the effect of sex and age on the incidence and survival of GC.
15736370|NCT04973618|Biological|APVO436|"APVO436
~Dosage: APVO436 will be administered at a fixed dosage of 18 mcg after a weekly ramp up during Cycle 1 (Step-up dosing: C1D15: 6 mcg over 22 hours, C1D22: 12 mcg over 8 hours, C2D1: 18 mcg over 6 hours, C2D8: 18 mcg over 4 hours), totaling 18 µg in Cycle 1 and 72 µg/cycle for Cycles 2-4 for a total of 234 µg for the projected 4-cycle treatment course.
~Dosage Form: IV Solutions for Intravenous Administration
~Frequency: Weekly"
15736371|NCT04973605|Drug|BGB-11417 + Dexamethasone|BGB-11417 orally at escalating doses administered in combination with dexamethasone
15736373|NCT04973579|Procedure|Simutaneous (single anaesthesia) carotid artery stenting with MicroNet covered stent (CGuard) and cardiac surgery (CABG or surgical valve replacement / repair procedure)|"The registry enrolls patients qualified for treatment with the methods evaluated in the registry, using routinely applicable procedures and devices.
~In cardiac surgery - surgical treatment systems for advanced ischemic heart disease and/or valvular disease (including - mechanical/biologic heart valves - regulatory approved for routine use and typically used at the Facility.
~In the simultaneous treatment of stroke-threatening carotid artery atherosclerosis - temporary neuroprotection systems (proximal, distal, according to medical indications and local experience) - regulatory approved for routine use and typically used at the center (for over 20 years).
~CGuard anti-embolic mesh stent system - a self-expanding nitinol carotid stent wrapped in MicroNet, which prevents fragments of atherosclerotic plaque from entering the lumen of the carotid artery - approved for routine use and typically used at the Center (over 5 years)."
15736377|NCT04973553|Other|upper limb rehabilitation|the intervention consisting of two components: a) Upper limb training protocol; b) Technology-assist training.
15736378|NCT04973540|Device|Iron Bioresorbable Scaffold System (IBS Angel)|Subjects in this arm will be implanted with IBS Angel.
15736379|NCT04973527|Drug|Efficacy of LCAR-T2C CAR-T cells|CD4-directed CAR-T cells administered with lymphoid depletion, and to obtain the preliminary efficacy results in subjects who have been diagnosed with relapsed or refractory CD4 positive T lymphocyte tumor
15736380|NCT04973514|Procedure|Cardiac surgery in grown-up congenital heart disease patients|Analysis of patient blood management, influence on 30 day and 6 month outcome
15736381|NCT04973501|Behavioral|Manual physiotherapeutic correction (MFK) Method|Patients undergo ambulatory physiotherapy :1-hour duration, twice a week for one month and once a week for next two months (16 therapies in total). Therapy was undertaken at the ambulatory section of the Department of Neurology, Kralovske Vinohrady University Hospital in Prague.
15736382|NCT04973501|Behavioral|Dynamic Neuromuscular Stabilization (DNS) Method|Patients undergo ambulatory physiotherapy :1-hour duration, twice a week for one month and once a week for next two months (16 therapies in total).Therapy was undertaken at the Department of Rehabilitation and Sport Medicine, Motol University Hospital.
15736383|NCT04973488|Other|Therapeutic plasma exchange|The intervention is a combination between the procedure of Therapeutic plasma exchange and biological transfusion of convalescent plasma from donors that have have COVID-19
15736384|NCT04973475|Drug|Indocyanine Green|Laparoscopic distal gastrectomy with lymph node dissection for early gastric cancer using Indocyanine Green Tracer
15736385|NCT04973462|Drug|standard treatment COVID-19 + Triazavirin|to evaluate the efficacy and safety (side effects and / or adverse effects) of Triazavirin and Oseltamivir as treatment of Coronavirus Disease 2019
15736386|NCT04973449|Biological|AZD1222|10 mM histidine/histidine hydrochloride, 7.5% (w/v) sucrose, 35 mM sodium chloride, 1 mM magnesium chloride, 0.1% (w/v) polysorbate 80, 0.1 mM edetate disodium, 0.5% (w/v) ethanol, at pH 6.6.
15736387|NCT04973449|Biological|AZD2816|10 mM histidine/histidine hydrochloride, 7.5% (w/v) sucrose, 35 mM sodium chloride, 1 mM magnesium chloride, 0.1% (w/v) polysorbate 80, 0.1 mM edetate disodium, 0.5% (w/v) ethanol, at pH 6.6
15736388|NCT04973436|Behavioral|Dialectical Behavioral Therapy Skills Training|Dialectical behavioral therapy skills training adapted for patients with metastatic lung cancer
15736389|NCT04973423|Radiation|MRI|2 additional MRI will be done for the CALM + MRI group
15736390|NCT04973410|Diagnostic Test|Coronary Physiology|Invasive coronary physiology measurements during diagnostic CAG with thermodilution method with the CoroFlow® (Coroventis, Uppsala, Sweden)
15736391|NCT04973410|Diagnostic Test|15O-H2O-PET scan|Myocardial blood flow (MBF) measured with oxygen-15 (O-15) labelled water used as a tracer molecule with positron emission tomography (PET)
15736392|NCT04973371|Diagnostic Test|Home-based point-of-care (POC) TB testing using GeneXpert device + MTB/RIF test|Those who screen positive for TB using the standard 4-question screener will be offered a GeneXpert® [Cepheid, Sunnyvale, CA] MTB/RIF test in their home with referral for clinic-based TB treatment initiation for those who receive a positive MTB/RIF test result.
15736393|NCT04973358|Other|buccotherm mouthwash|twice a day for 14 weeks
15736394|NCT04973358|Other|placebo mouthwash|twice a day for 14 weeks
15736395|NCT04973345|Drug|Terbutaline|management of asthma symptoms
15736397|NCT04973319|Drug|Pyrotinib|Each subject in the test group will receive the test drug (pyrotinib) for 52 weeks, and will be followed up for at least 3 years from the start of randomization, until disease recurrence, intolerable toxicity, withdrawal of informed consent, or termination of the medication as per the investigator's judgment.
15736398|NCT04973319|Drug|Trastuzumab|Each enrolled subject will complete at least ≥ 24 weeks (8 drug delivery cycles) of trastuzumab combined with pertuzumab in the neoadjuvant and/or adjuvant treatment phase.
15736399|NCT04973306|Procedure|Neoadjuvant Chemoradiotherapy|"Chemotherapy: carboplatin (AUC 2 mg/mL per min) and paclitaxel (50 mg/m2 of body-surface area) were administered intravenously for five cycles, starting on days 1, 8, 15, 22, and 29. For each cycle, Carboplatin and paclitaxel were administered 30 minutes apart.
~Radiotherapy: A total radiation dose of 41.4 Gy was given in 23 fractions of 1.8 Gy, 5 days per week (Radiotherapy was performed on the 2nd, 3rd, 4th, 5th, and 6th day in each cycle, and only 3 times in the 5th cycle)"
15736400|NCT04973306|Drug|Tislelizumab|"Tislelizumab (200mg/time) was administered intravenously on the 1st and 22nd day.
~The intravenous injection lasts about 30 minutes (micropump is recommended, intravenous bolus is prohibited, duration should be not less than 20 minutes and not more than 60 minutes);"
15736401|NCT04973306|Procedure|Ivor-Lewis or Mckeown Esophagectomy(Mckeown Esophagectomy recommended)|After neoadjuvant therapy, patients in groups receive Ivor-Lewis or Mckeown Esophagectomy (Mckeown Esophagectomy recommended)
15736402|NCT04973293|Drug|sintilimab|Sintilimab 200 mg, 4 cycles of treatment before surgery
15736403|NCT04973293|Drug|bevacizumab|bevacizumab 15 mg/kg, 4 cycles of treatment before surgery
15736404|NCT04973267|Behavioral|Game Plan for PrEP|See arm description.
15736407|NCT04973254|Other|Standard treatment within an HIV clinic|Standard of care for HIV positive patients will be provided in the HIV clinic that may include HIV medication or may include oral medications.
15736408|NCT04973241|Radiation|OPG & CBCT|panoramic images , cone beam computed tomography
15736409|NCT04973228|Drug|ARQ-154 - Active|ARQ-154 Foam 0.3% - Active
15736410|NCT04973228|Drug|ARQ-154 Vehicle|ARQ-154 Foam - Vehicle
15736411|NCT04973215|Other|no intervention|this is not an intervention study
15736413|NCT04973189|Drug|SHR-1707|A single dose of SHR-1707 by intravenous (IV) infusion in healthy young adults.
15736414|NCT04973189|Drug|Placebo|A single dose of matching SHR-1707 placebo by intravenous (IV) infusion in healthy young adults.
15736415|NCT04973189|Drug|SHR-1707|A single dose of SHR-1707 by intravenous (IV) infusion in elderly subjects.
15736416|NCT04973189|Drug|Placebo|A single dose of matching SHR-1707 placebo by intravenous (IV) infusion in elderly subjects.
15736417|NCT04973176|Device|Standard Bougie|Standard Bougie for endotracheal intubation
15736418|NCT04973176|Device|Flexi-tip Bougie (P3 Medical Bristol,UK)|Flexi-tip Bougie for endotracheal intubation
15736419|NCT04973163|Drug|BI 1823911|BI 1823911
15736420|NCT04973163|Drug|BI 1701963|BI 1701963
15736421|NCT04973163|Drug|Midazolam|Midazolam - only administered in Part B (dose confirmation) of the Monotherapy Arm
15736422|NCT04973150|Behavioral|To explore whether pretreatment with eye covering can reduce the incidence of acute delirium and the score of delirium after general anesthesia in ophthalmology pre-age children.|To explore whether pretreatment with eye covering can reduce the incidence of acute delirium and the score of delirium after general anesthesia in ophthalmology pre-age children. Methods A total of 300 preschool-age children who underwent general anesthesia of selective ophthalmic surgery in a 3A grade hospital from August 2019 to July 2020 were selected as the research object, who were divided into experimental group and control group with 150 cases each by random number table. Children in the control group received regular education on cartoon animation videos before surgery; children in the experimental group received eye-covering pretreatment on the basis of cartoon animation videos. The differences in preoperative anxiety degree score, postoperative acute delirium incidence, delirium degree score, and postoperative nursing care difficulty score were compared between the two groups.
15736426|NCT04973124|Drug|Dexmedetomidine|These participants will receive intraoperative dexmedetomidine.
15736427|NCT04973124|Drug|Placebo|These participants will not receive intraoperative dexmedetomidine.
15736428|NCT04973111|Drug|CT-868 as SC Injection|CT-868
15736429|NCT04973111|Drug|Placebo as SC Injection|Placebo
15736430|NCT04973111|Drug|Active Comparator as SC Injection|Active Comparator
15736431|NCT04973098|Biological|CT0181 Cells|5 dose levels each with or without lymphocyte clearance were tentatively determined.
15736432|NCT04973085|Device|Cold or body temperature circulated water|"Water will be circulated through an adhesive wrap, applied to the front of the participant's neck, for 2 hours in either the cold (experimental) or body temperature (active comparator) study arm.
~Subject's will be randomized to one study arm, then cross over to the other study arm after completion of their first intervention."
15736433|NCT04973072|Behavioral|One large reward treatment|Participants will be awarded S$300 for reaching the PBF goal at the end of 12 weeks.
15736434|NCT04973072|Behavioral|Small wins treatment|The cash rewards that participants will receive are capped by $300 and depend on which IGs they achieve and whether they maintain their progress at the end of the 12 weeks. Specifically, given the PBF goal, the Loss Target (LT) is the difference between the initial PBF measured at the first visit and the PBF goal, i.e., LT = initial PBF - PBF goal. Then, the IG1 is to achieve 25% of the LT, the IG2 is to achieve 50% of the LT, and the IG3 is to achieve 75% of the LT. Participants will earn $75 credits to their accounts on the programme website for reaching each intermediate goal. Also, when they miss IG1 and/or IG3, they can earn the previous missing $75 credits if they reach the IG2 and the LT. At the end of the 12 weeks, they will lose some or all the credits that they have accumulated if they fail to maintain the progress, and they will only receive the corresponding amount in cash
15736435|NCT04973059|Device|SmartDrive Summer|The SmartDrive is a power assist accessory for a manual wheelchair
15736436|NCT04973059|Device|SmartDrive Winter|The SmartDrive is a power assist accessory for a manual wheelchair
15736437|NCT04973033|Drug|Tofacitinib|patients enrolled were prescribed tofacitinib 5mg twice a day orally.
15736438|NCT04973020|Drug|SHR6390、efavirenz|SHR6390 tablet single dose；Efavirenz single dose.
15736439|NCT04973007|Drug|Gadoxetate disodium|Gadoxetate disodium is now mainly used for the purpose of HBP liver MR imaging to save MR scanner time and total examination time.
15736440|NCT04973007|Drug|Gadobenate dimeglumine|The most commonly used MR contrast agent in abdominal imaging is gadobenate dimeglumine, which has mainly the characteristics of an extracellular agent used for most indications of MR examinations.
15736441|NCT04972994|Procedure|laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies|laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies in management of colonic cancers
15736442|NCT04972981|Drug|ADCT-901|Intravenous infusion
15736446|NCT04972955|Device|Libre Freestyle Pro IQ|Participants will wear a flash glucose monitoring device, the Libre Freestyle Pro IQ, for two weeks following delivery.
15736447|NCT04972942|Drug|Daratumumab|"Total body irradiation (TBI)-based myeloablative allogeneic hematopoietic stem cell transplantation (HCT) using best available donor.
~Daratumumab (DARA) treatment post-HCT
~Induction: DARA 16 mg/kg IV weekly x 8 doses (Weeks 1-8)
~Consolidation: DARA 16 mg/kg IV every 2 weeks x 8 doses (Weeks 9-24)
~Maintenance: DARA 16 mg/kg IV every 4 weeks x 5 doses following start of treatment (Weeks 25-44)"
15736448|NCT04972929|Other|Spinal Manipulation|Diversified (i.e. crossed bilateral hypothenar contact) chiropractic technique will be administered at levels of identified spinal joint restriction/dysfunction (derived from thoracic spine x-rays, static and motion palpation, and confirmed or provoked localized tenderness in paraspinal soft tissues).
15736449|NCT04972929|Other|Sham Spinal Manipulation|Sham-SM will be delivered by setting the expansion control knob on an Activator II (Activator Methods®, Phoenix AZ) device to the zero position (off; no thrust) and placed onto the dorsal thumb surface of the clinician (no actual instrument contact with study participant). At a setting of zero, no excursion of the Activator II stylus occurs, despite the device delivering an audible clicking sound, with no biomechanical force being imparted to the participant.
15736450|NCT04972916|Other|Patient navigation-based tobacco harm reduction intervention|At the first intervention interview, the patient navigators will educate participants about the benefits of quitting, introduce smoking cessation resources, motivate participants to link with treatment, help participants attend smoking cessation treatments, and assess barriers that prevented them from being able to consider smoking cessation. The cessation treatment resources will be discussed include PennState Health Smoking Cessation Clinic, Pennsylvania Quitline, or visiting their primary care provider (PCP) to discuss cessation, prescription medications, and/or nicotine replacement therapy. A follow-up call will be made 1 month later to further assist and motivate to use tobacco treatment services, and assess interim tobacco treatment engagement outcome.
15736451|NCT04972890|Biological|stem cells|Using umbilical cord stem cells 15x10^6 cells in 2 cc saline/NaCl 0,9% solution
15736452|NCT04972890|Other|placebo|using 2 cc saline/NaCl 0,9% solution
15736453|NCT04972877|Other|Treatment group protocol|"For treatment group, two groups of acupoints will be used alternatively. The first group consists of some acupoints. The patients will be asked to stay in supine position. Disposable sterilized needles (Size: 0.25*40/50 mm) will be inserted into a depth of 15~35 mm and stimulated manually to evoke needle sensation. And then some acupoints will be thereafter connected to electrical stimulators and stimulated with low-frequency and the maximum tolerated intensity of the patients. The other needles without electrical stimulators will be manually stimulated to evoke Deqi every 10 minutes.
~The second group consists of other acupoints. Patients will be asked to stay in prone position. The stimulation will be in the same way as the first group."
15736454|NCT04972877|Other|Control group protocol|"For control group, four pseudo-acupoints are used, with two points on each shoulder and the two on each upper arm, which are not located on any meridians. The patients will be asked to stay in supine position and keep the whole body relaxed and comfortable. Disposable sterilized needles (Size: 0.18*25 mm) will be inserted superficially to a depth of < 5 mm without any manual stimulus and the needle sensation (Deqi in TCM) should not be evoked. Electrodes are connected to the needles, but the stimulators should be turned on at an intensity of zero. Each intervention lasts for 30 minutes."
15736455|NCT04972864|Other|Exercise training group|A regular advanced exercise program was given and followed.
15736456|NCT04972864|Other|Control training group|Basic exercises was given at the beginning and did the same exercises
15736457|NCT04972851|Behavioral|Self-Determined Learning Model of Instruction (SDLMI)|"SDLMI is a teaching model that enables providers to teach students to:
~make choices and decisions about setting a goal
~develop action plans for academic or other goals
~self-monitor and self-evaluate progress toward goal attainment
~adjust the goal or plan"
15736458|NCT04972838|Behavioral|Remaking Recess (RR)|Remaking Recess is a flexible, school-based social engagement intervention for students with autism and their peers. The research team will work with school personnel to deliver RR during recess. RR is tailored based on the needs of schools, students, and staff.
15736459|NCT04972825|Behavioral|Mind the Gap|This intervention will help parents with children newly diagnosed with autism or other neurodevelopmental disorders learn how to navigate the system of acquiring services for their child. These parents will be assisted by a coach, an employee at the child's agency, that will help them through this process.
15736460|NCT04972799|Other|injection of autologous fat at Day 0 and injection of saline at 6 months|injection into the intersphincter space
15736461|NCT04972799|Other|injection of saline at Day 0 and injection of autologous fat at 6 months|injection into the intersphincter space
15736462|NCT04972786|Device|Repetitive Transcranial Magnetic Stimulation|TMS pulses will be delivered through an air-cooled coil in either a figure-eight or double-cone shape, with the latter being particularly useful for targeting deeper structures such as dACC. The first phase of the TMS protocol will involve a standardized motor-thresholding procedure, wherein peripheral responses evoked by single TMS pulses are recorded via an electromyographic recording device. In this phase, the TMS coil's stimulation intensity is titrated to a level that is comfortable yet effective at reliably exciting neuronal populations orthogonal to the coil (50% motor-evoked potentials ≥50 microvolts; typical duration≈20-40 mins). Then repetitive TMS (rTMS) will be administered to a pre-determined cortical target based on the individual's pre-TMS fMRI scan using a Localite Neuronavigation system (duration≈10-20 mins). The rTMS protocol will involve the delivery of a train of TMS pulses over a cortical target prior to performance of behavioral tasks during a post-rTMS fMRI scan.
15736463|NCT04972773|Behavioral|Mindfulness meditation (MM)|"Towards this additional MM practice, participants will be able to use any combination of the MM apps: Insight timer, which focuses on community/group-like therapy, Healthy minds, which focuses on resilience that is essential in disability adjustment, and Smiling mind, that reminds patients of their family/support structures. These three options were chosen for delivering free MM with different focuses that would cater to the variety of SCI patients needs. Participants will be alerted if they are not achieving 30 minutes of additional MM per week. This will guarantee that the treatment group have a higher time spent on MM for dose-response analysis. Participants will receive a reminder email (see attached) on the Sunday evening of a week with <30 minutes of additional MM encouraging them to use their mindfulness app."
15736464|NCT04972760|Drug|Baricitinib|Baricitinib, 4 mg/d, oral route for 24 weeks
15736465|NCT04972760|Drug|Placebo|Placebo, 4 mg/d, oral route for 24 weeks
15736487|NCT04972552|Other|Usual Diet|Participants will be asked to eat a usual diet but not eat any watermelon as part of their usual diet
15736488|NCT04972552|Other|Placebo|Participants will be asked to take 800-1200 mg of a placebo capsule per day
15736489|NCT04972539|Drug|AJU-A51 Tab.|Single oral dose AJU-A51(Dapagliflozin/Linagliptin) 10 mg / 5 mg FDC tablet
15736490|NCT04972539|Drug|A51R1 Tab. and A51R2 Tab.|Single oral dose A51R1(Dapagliflozin) 10 mg tablet and A51R2(Linagliptin) 5 mg tablet taken together
15736466|NCT04972747|Other|skin care with sunflower oil|The application will be carried out twice a day during the maintenance hours of the service. In skin care applications, body baths are applied not more than three times a week, as it may cause hypothermia in preterm babies in the ward routine. In daily skin care, body cleaning with cotton, changing the fixation points such as orogastric probe, and changing the monitor probe locations are among the routine practices. In order to hydrate and moisturize the skin in preterm and term babies, baby oil in the service is used. Skin care applied in the service routine will be applied to the preterm babies included in the study, and only sunflower oil and coconut oil will be used as moisturizers.
15736467|NCT04972734|Biological|premature newborns developing a NEC|weekly Blood sample and daily Stools sample during 12 weeks + Blood and stool sample during NEC
15736468|NCT04972734|Biological|premature newborns without NEC|weekly Blood sample and daily Stools sample during 12 weeks
15736469|NCT04972721|Other|No treatment given|The study is non-interventional with no study-specific treatment during the study and the patients will be treated as per Treating Physician's and patient's own discretion.
15736470|NCT04972708|Genetic|Cross-sectional genetics study|Cross-sectional genetics study
15736471|NCT04972695|Diagnostic Test|Fundus Photographs (retinographies)|Fundus photographs under mydriasis
15736473|NCT04972669|Device|Electrical Acupuncture Stimulation|Participants received acupuncture at bilateral Baliao. After skin disinfection, sterile adhesive pads were placed on bilateral Baliao, and acupuncture needles were inserted through the adhesive pads. Following needle insertion, small, equal manipulations of twirling, lifting, and thrusting were performed on all needles to reach de qi. Electrodes from the electroacupuncture apparatus were attached transversely to the needle handles. The electroacupuncture stimulation lasted for 30 minutes with a continuous wave of 2-15 Hz. Participants received 3 treatment sessions per week (ideally every other day) for 6 consecutive weeks, 18 sessions in total.
15736474|NCT04972669|Device|sham Acupuncture|Participants received sham acupuncture at locations one inch besides bilateral Baliao without needle insertion. Electrodes from the electroacupuncture apparatus were attached transversely to the needle handles. The electroacupuncture stimulation lasted for 30 minutes with a continuous wave of 2-15 Hz. Participants received 3 treatment sessions per week (ideally every other day) for 6 consecutive weeks, 18 sessions in total.
15736475|NCT04972656|Drug|Ambrisentan|"Titration:
~Monotherapy using ambrisentan will be initialized at a beginning dose of 5 mg (once daily). Drug intake is scheduled at the morning. After 4 weeks monitoring, the dose of ambrisentan will be uptitrated to 10 mg once daily. Otherwise, if intolerability is indicated, a dose of 5 mg (once daily) will be maintained through the study duration.
~Maximum dose allowed: not to exceed 10 mg/day.
~Administration:
~Ambrisentan will be administered orally with or without food intake."
15736476|NCT04972656|Drug|Placebo|"Placebo tablet (one to two tablets corresponding to one to two verum tablets).
~Administration:
~Placebo will be administrated orally with or without food intake in the morning."
15736477|NCT04972643|Dietary Supplement|EPA|EPA 2000mg Soft capsules
15736478|NCT04972643|Dietary Supplement|DHA|DHA 2000mg Soft capsules
15736479|NCT04972643|Dietary Supplement|Placebo|Placebo Soft capsules
15736480|NCT04972630|Behavioral|Pal-Care|"Pal-Care intervention participants will receive a 6-month intervention based upon the WHO toolkit and it will be delivered by the community health workers (CHWs). The goal of this pragmatic clinical trial is to test and evaluate a home-based palliative care intervention for utilizing community health workers to facilitate the delivery of palliative care to cancer patients in rural India. More details provided in the intervention arms section. After the intervention, clinicians, CHWs and a purposefully selected set of patients/caregivers, who were involved in the Pal-Care will be interviewed to understand their experiences, needs, expectations, barriers, facilitators and strategies."
15736481|NCT04972630|Behavioral|Control-Usual Care|"The control group will receive usual care palliative services in which the patient or caregiver (by proxy) must visit the Tata Medical Center (TMC) cancer center for care. TMC services include consultation with a multi-disciplinary team (oncologist, nurse, psychologist), a 21-day morphine supply at reduced cost (as morphine is regulated in use),basic training on medication usage, catheter and wound care, other topics as relevant,and psychological counseling. Patients (or their proxy) must return to the cancer center as needed for follow up care and they are provided a 24/7 hotline to call in case of emergency."
15736482|NCT04972617|Diagnostic Test|albumin function analysis (ABIC)|After centrifugation (10 minutes at 4000 rpm), the plasma is aliquoted and stored at minus 80° C until further analysis. The free as well as the total furosemide concentration is determined by HPLC. In addition to the characterisation of the albumin function by means of the ABiC, these samples can also be used for the determination of the albumin concentration (prerequisite for the determination of the ABiC) and free furosemide concentration as well as for the determination of further parameters relevant for the albumin function.
15736483|NCT04972578|Device|Suture Button vs Screw Fixation|Syndesmotic fixation utilizing suture button fixation versus Screw Fixation (placing one or two screws across the syndesmosis)
15736484|NCT04972565|Behavioral|Usual Care plus Inspiratory Muscle Training (IMT)|Participants will receive usual care and will also be provided with a personalized prescription for an IMT program for 8 weeks. Participants will perform two daily IMT sessions of 30 breaths (< 5 minutes/session), 5 days per week in their home environment. IMT intensity will be progressed weekly by 5-10% of the baseline maximal inspiratory pressure if the Borg Dyspnea score is < 7.
15736485|NCT04972552|Dietary Supplement|coenzyme Q10|Participants will take 800-1200 mg of coenzyme Q10 capsule per day
15736491|NCT04972513|Procedure|Biospecimen Collection|Undergo collection of blood
15736496|NCT04972513|Procedure|Endothelial function|Endothelial function will be assessed with the EndoPAT device, which measures changes in pressure from sensors placed on the fingertip
15736497|NCT04972500|Dietary Supplement|Nutricia Pre-op, 400 milliliters, per os|After 10 hours of fasting participants will receive per os 400 milliliters of Nutricia Pre-op
15736498|NCT04972487|Drug|Tofersen|Administered as intrathecal bolus injection
15736499|NCT04972474|Other|Smartphone app in-app components|Insightful notification text, data visualisation, research team contact details.
15736500|NCT04972435|Diagnostic Test|Contrast sensitivity|All subjects performed the contrast sensitivity measurement preoperatively and one time at 2 months postoperatively.
15736501|NCT04972422|Drug|ZN-c3|ZN-c3 is a study drug
15736502|NCT04972396|Drug|ALT-801|Injected subcutaneously (SC)
15736503|NCT04972396|Drug|Metformin|Taken by mouth (PO)
15736504|NCT04972396|Drug|Atorvastatin|Taken by mouth (PO)
15736505|NCT04972396|Drug|Warfarin|Taken by mouth (PO)
15736506|NCT04972396|Drug|Digoxin|Taken by mouth (PO)
15736507|NCT04972396|Drug|Ethinylestradiol and Levonorgestrel|Taken by mouth (PO)
15736508|NCT04972383|Combination Product|Platelet Rich Plasma|In the Platelet Rich Plasma group, 4mL Platelet Rich Plasma was given.
15736509|NCT04972383|Combination Product|Hyaluronic Acid|In the Hyaluronic group, 3mLHYAJOINT Plus was given.
15736510|NCT04972370|Other|Patients with Unilateral Cleft Lip with or without Cleft Palate|2 dimensional Photographs of patients with unilateral cleft lip with or without cleft palate
15736511|NCT04972344|Diagnostic Test|Ionized magnesium|Assessment of ionized magnesium level
15736512|NCT04972331|Procedure|Arthroscopic Partial Meniscectomy|"Arthroscopic partial meniscectomy was performed by three senior surgeons using two standard portals, no outflow cannula, a 5.5-mm 30° arthroscope, and a pressure-controlled irrigation system.
~A standard surgical protocol was used to document possible findings in the cartilage, ligaments, synovium, and medial and lateral meniscus. In each case, surgery was limited to resection with limited debridement of the articular surface lesion, preserving as much of the meniscus as possible. Patients who underwent additional procedures, such as removal of loose bodies or subchondral drilling for any articular lesions, were excluded from this study (Figure 1). No patients underwent total meniscectomy or meniscal repair."
15736513|NCT04972331|Procedure|Platet- Rich-Plasma|Peripheral venous blood was collected from all patients, which was then centrifuged to isolate red blood cells from the upper plasma layer. We used the Arthrex® kit APC®. The upper plasma layer was carefully collected with a serological pipette and placed in a new centrifuge tube or set aside for injection. The 5 mL remaining upper plasma layer was centrifuged again to separate platelet-poor plasma from PRP for 7 min. We activated the PRP sample by adding calcium chloride through ultraviolet irradiation, and then a 4- to 8-mL sample was used for two injections. One injection was performed intra-articularly with a supero-lateral approach. One ultrasound-guided injection was performed at the meniscal wall. Our protocol allowed us to have < 1% blood cells and <1% white cells in the injection.
15736514|NCT04972331|Other|Post-intervention|All patients were discharged the day after surgery with no limitation of mobility but with restrictions on sports for four weeks. Interruption of work was given for 10-45 days. The same analgesics and NSAIDs were administered in both groups for two weeks. All patients then received a rehabilitation program conducted by a physiotherapist, using the same protocol as in the PRP group for four weeks.
15736515|NCT04972318|Procedure|Positive end-expiratory pressure titration with driving pressure control|Positive end-expiratory pressure will be tailored during a decremental maneuver (without a formal alveolar recruitment maneuver). The best positive end-expiratory pressure will be defined as the one associated with the higher respiratory system compliance, up to 20 cmH2O. Plateau pressure limit will be 30 cmH2O. If driving pressure remains elevated after optimal PEEP setting, tidal volume will be reduced to keep driving pressure below 14 cmH2O.
15736516|NCT04972318|Procedure|ARDSNet ventilatory strategy|Positive end-expiratory pressure will be set according to fixed inspired oxygen fraction values.
15736517|NCT04972305|Other|Exercise and ergonomics|12 week exercise and fit bike
15736518|NCT04972305|Other|Ergonomics|Fit bike
15736519|NCT04972292|Drug|FDC of codeine 30 mg/dipyrone 500 mg|Group 1: receive one (1) experimental drug tablet (FCD of codeine 30mg/dipyrone 500mg) + one (1) Tylex® placebo.
15736520|NCT04972292|Drug|Tylex|Group 2: receive one (1) Tylex® tablet (codeine 30 mg/paracetamol 500 mg) + one (1) FDC placebo tablet
15736521|NCT04972279|Behavioral|Digital message (text + image)|"Messages can be up to 256 characters of text with an image. Move more and sit less messages were written to target established cognitive and affective constructs associated with physical activity (e.g., prompts to action plan, guidance for maximizing pleasure by regulating intensity)."
15736522|NCT04972266|Device|AcumenTM Hypotension Prediction Index software|The AcumenTM HPI Feature Software provides the clinician with physiological insight into a patient's likelihood of trending toward a hypotensive event. The AcumenTM HPI Feature Software suite is enabled by the minimally invasive Acumen IQ sensor.
15736523|NCT04972253|Drug|Infigratinib|Oral, dosage per protocol
15736524|NCT04972240|Other|customization of abutment|we will customize abutment for every patient not ready made
15736525|NCT04972227|Drug|CY6463|oral tablets
15736526|NCT04972227|Drug|Placebo|oral tablets
15736527|NCT04972201|Device|Multi-cancer early detection test|Blood collection and multi-cancer early detection test
15736528|NCT04972188|Drug|ZYIL1 Capsule|NLRP3 inflammasome inhibitor
15736529|NCT04972175|Drug|50-Hour Intervention - Rapid Insulin lispro|Subcutaneous-delivery of insulin lispro using pump therapy.
15736530|NCT04972175|Drug|50-Hour Intervention - BC LisPram|Subcutaneous-delivery of BC LisPram using pump therapy.
15736531|NCT04972136|Device|Active Bilateral Theta Burst Stimulation|A total of 30 active BL-TBS sessions. Stimulation will begin with right DLPFC (cTBS) followed by left DLPFC (iTBS)
15736532|NCT04972136|Device|Sham Bilateral Theta Burst Stimulation|A total of 30 sham BL-TBS sessions. Stimulation will begin with right DLPFC (cTBS) followed by left DLPFC (iTBS)
15736533|NCT04972123|Drug|CPC - Capsaicin, Phenylephrine, Caffeine|CPC is a combination of Capsaicin, Phenylephrine and Caffeine
15736698|NCT04970953|Procedure|Right heart catheterization|Right heart catheterization will be performed via a brachial access under sonographic guidance and hemodynamic measurements will be performed in a semi-supine position.
15736534|NCT04972123|Diagnostic Test|Tilt Table Test|Participant will undergo tilt tablet testing using the Italian protocol (see reference section). The Italian protocol includes 20 minutes of passive tilt at 70 degrees (Passive Phase) followed by nitrogylcerin (NTG) administration and tilt testing for another 15 minutes (NTG Phase).
15736535|NCT04972123|Drug|Placebo|Placebo for CPC
15736536|NCT04972110|Drug|RP-3500|RP-3500 (ATR inhibitor) in combination with Niraparib or Olaparib (PARP inhibitors)
15736537|NCT04972097|Device|Irreversible Electroporation|IRE of the prostate is typically performed with the subject in the lithotomy position, with 2-6 monopolar probes placed through the perineum using a brachytherapy grid and ultrasound or CT guidance. IRE supplies the targeted tissue with high voltage (2-3 kV) direct current pulses lasting up to 100 microseconds through the electrode probes.
15736538|NCT04972084|Device|Powerscope group|Treatment of Class II malocclusions using Powerscope appliance
15736539|NCT04972071|Other|Knowledge translation (KT) of the CSRS based practice recommendations|The components of the practice recommendations include: 1) evidence-informed systematic clinical evaluation with appropriate history, physical examination and in-ED investigations (e.g., troponin testing, work-up for pulmonary embolism and CT head) for detecting serious underlying conditions and predicting 30-day serious outcomes; 2) application of the CSRS for risk-stratification at the end of ED visit after no serious underlying conditions for the syncope were identified; 3) use of patient information materials to aid in disposition; and 4) the use of 15-day outpatient cardiac monitoring for CSRS medium and high-risk patients upon ED discharge. All the components of the practice recommendations will be applied by the ED physician treating the patient.
15736540|NCT04972045|Drug|CuminUP60®|4 capsules, 400 mg / capsule
15736541|NCT04972045|Drug|Curcumin capsules|4 capsules, 400 mg / capsule
15736542|NCT04972032|Device|Estrogen Intrauterine Stent System|A Estrogen Intrauterine Stent System（E-IUS）will be introduced post-operatively. The E-IUS will be removed 60 days after surgery with continuous dydrogesterone administration for 5 days at 20 mg/d, and routine management.
15736543|NCT04972032|Device|Foley balloon combined with self-cross-link sodium hyaluronate gel|Foley balloon combined with self-crosslinking sodium hyaluronate gel will be introduced post-operatively，2 cycles of estrogen-progestin sequential therapy comprised of continuous estrogen and progestin added in the second half of the cycle or continuous estradiol valerate for 60 days, followed by dydrogesterone for 10 days
15736544|NCT04972019|Device|Telerehabilitation Experimental Group|"Experimental training will occur in the home. The experimental training will last 8 weeks, each week having up to 4 sessions of therapeutic game play (based on tolerance). Each session will start with vitals being measured and logged.
~Experimental group will wear a wearable computer system modified with biosensors, then do motor and cognitive baselines. Subsequently, participants in that group will play an increasing number of games, targeted to the major cognitive domains of executive function (primary), memory and attention.
~At the end of every other week participants and their caregivers in the experimental group will fill a subjective evaluation questionnaire aimed at gauging perceived benefits and possible technical difficulties when using the experimental system. Questions will be scored on a 5-point Likert scale."
15736545|NCT04972019|Other|Telerehabilitation Sham Control Group|"Sham control group will train playing web games while wearing a biosensor connected to a laptop provided, showing the web games. However biosensor data will not be used to control game difficulty.
~Sham group controls will play the same frequency and duration of sessions, however those will consist of web games training the same domains (memory, focusing, executive function). Interaction will be through a mouse, and data will be downloaded to the same server as that used for the experimental group."
15736546|NCT04972006|Behavioral|Remote, intensive intervention for injection phobia|The intervention consists of a 1.5 hour session that provides youth with education about anxiety and a 3 to 4 hour session consisting of graduated exposure to injection fear.
15736547|NCT04971993|Device|Wearable Cardiac Monitor|Participants will be fitted with a wearable cardiac monitor placed on their skin that measures physiological signals.
15736548|NCT04971980|Drug|hUC-MSC infusion (BC-U001)|The participants are intravenously administered a single infusion of hUC-MSC at 0.5x10^6 cells/kg body weight, 1.0x10^6 cells/kg body weight, 1.5x10^6 cells/kg body weight for low-dose cohort, medium-dose cohort and high-dose cohort respectively.
15736549|NCT04971967|Combination Product|Crowdsourced partner services intervention|The intervention includes the provision of provider referral and dual referral services, crowdsourced materials such as postcards and an HTML aiming to promote PS, as well as free take-home HIV self-testing kits.
15736550|NCT04971954|Other|Nicotine gum|Nicotine (6 mg) will be administered in the form of polacrilex gum that is available as an over-the-counter medication
15736551|NCT04971954|Other|Placebo gum|The placebo will also be a commercially available gum that resembles the nicotine gum in flavor, size, shape, color, and texture.
15736552|NCT04971941|Device|Dental Vibe|Use of Dental Vibe during dental anesthesia intervention
15736553|NCT04971928|Drug|GSK3228836|GSK3228836 will be administered
15736554|NCT04971915|Other|minimalist footwear|The intervention consists of wearing the minimalist footwear in recommended progression during the interventional period (3months). The using progression will start at around one hour a day in the first week, then will be increased to fully use (if possible) over the final period according to the participant´s tolerance rate to the footwear wearing. The consultation about the subjective effect of footwear will take place after the first month of wearing. Also, there will be the opportunity to consult any issue connected with footwear or their wearing through the duration of research.
15736555|NCT04971902|Other|Pharmacogenetic Test|Cheek swab sample with PGx results lab analysis
15736556|NCT04971889|Behavioral|Diabetes MNT|Group-based MNT sessions that provide evidence-based dietary self-care information, behavioral skills, and goal setting related to managing carbohydrate and fat intake
15736557|NCT04971889|Behavioral|Motivational Interviewing|Group-based support for dietary self-care motivation using culturally-adapted motivational interviewing exercise
15736558|NCT04971876|Device|HLR-1|Initial injection of HLR-1 and optional TU after 4 weeks. Maximum injection volume for each treatment session is 3mL.
15736559|NCT04971876|Device|HLR-2|Initial injection of HLR-2 and optional TU after 4 weeks. Maximum injection volume for each treatment session is 3mL per NLF.
15736560|NCT04971876|Device|HLR-3|Initial injection of HLR-3 and optional TU after 4 weeks. Maximum injection volume for each treatment session is 4mL per cheek.
15736561|NCT04971850|Other|Sleep study|"Procedures added by research during PSG :
~SDB screening questionnaires
~Electromyography (EMG) of accessory and abdominal muscles
~Cerebral oxygenation
~Mandibular movements
~Sleep headband (pre-teens and teens) or other connected device
~Automatic PSG analyzes
~Psychological and neuropsychological assessment The recordings of the study will be repeated at one year if the patient needs a treatment (surgery or noninvasive ventilation) following the results of the PSG."
15736562|NCT04971837|Dietary Supplement|Cannabidiol (CBD) powder formulation|T-P-S-10 Caliper powder - 30 mg CBD in the form of 300 mg of 10% CBD isolate
15736563|NCT04971837|Dietary Supplement|Cannabidiol (CBD) Oil based tincture formulation|30 mg CBD isolate in MCT oil (1:1 ratio of CBD to Medium Chain Triglycerides oil)
15736564|NCT04971837|Dietary Supplement|Cannabidiol (CBD) Gum Arabic, maltodextrin base formulation|10% CBD Gum Arabic, maltodextrin base
15736565|NCT04971837|Dietary Supplement|Cannabidiol (CBD) Gum Arabic, sorbitol base formulation|10% CBD Gum Arabic, sorbitol base
15736566|NCT04971837|Dietary Supplement|Cannabidiol (CBD) Isolate in water formulation|formulation
15736567|NCT04971837|Dietary Supplement|CBD matching Placebo|Matching Placebo
15736568|NCT04971824|Procedure|Physiotherapeutic intervention|The physiotherapy consists in performing visceral manipulation of the pelvic and abdomen organs as well as doing special exercises (volunteers get a handout with instructions on how to exercise). The exercises include ones from the Mojzis´s method, Dynamic neuromuscular stabilisation, yoga or other therapeutic methods used by physiotherapists.
15736571|NCT04971798|Biological|Cell-free Stem Cell-derived Extract Formulation (CCM)|Intraarticular injection
15736576|NCT04971759|Drug|Levobupivacaine|Levobupivacaine 5%
15736577|NCT04971759|Drug|Dexmedetomidine Hydrochloride|Levobupivacaine 5% + 1 µg/kg dexmedetomidine.
15736578|NCT04971759|Drug|Fentanyl|Levobupivacaine 5% + 1µg/kg fentanyl
15736579|NCT04971746|Drug|Pirfenidone|On Days 1 and 13, participants will receive an oral dose of pirfenidone.
15736580|NCT04971746|Drug|GLPG4716|From Day 3 to Day 14, participants will receive GLPG4716 daily.
15736581|NCT04971746|Drug|Nintedanib|On Days 1 and 13, participants will receive an oral dose of nintedanib.
15736582|NCT04971733|Drug|E2814|E2814 intravenous infusion.
15736583|NCT04971720|Drug|Sacubitril-Valsartan 49 Mg-51 Mg Oral Tablet|The subject will be randomized, in a double-blind manner to sacubitril/valsartan 49/51 mg once in the morning or once in the evening for a period of 7 days.
15736584|NCT04971720|Drug|Valsartan 80 mg Oral Tablet|The subject will be randomized, in a double-blind manner to valsartan 80 mg once in the morning or once in the evening for a period of 7 days.
15736585|NCT04971720|Other|Standardized Study Diet|The standardized diet consisted with eucaloric meals of 4.5 gm sodium per day for 14 days.
15736586|NCT04971707|Other|Standardized exercise training|HRV index will be measured every morning during 5 min. This group will benefit from the standard cardiovascular rehabilitation program combining both continuous moderate exercise sessions (MICT) and high intensity interval exercise sessions (HIIT). MICT sessions will be performed 2 times per week and HIIT sessions will be performed once a week.
15736587|NCT04971707|Other|HRV-guided exercise training|HRV index will be measured every morning during 5 min. This group will benefit from the individualized cardiovascular rehabilitation program. Daily exercise (MICT, HIIT, or active recovery) will be prescribed according to the HRV-index measured on the morning of the session.
15736588|NCT04971694|Other|No interventions or procedures|This is a retrospective observational study and data will be collected from the subject's existing medical record. No interventions or procedures will be required for this study.
15736589|NCT04971681|Device|Low frequency repetitive transcranial magnetic stimulation (rTMS)|Subjects will receive one session of low frequency repetitive transcranial magnetic stimulation (rTMS) targeting the medial prefrontal cortex (mPFC), within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 110% of motor threshold (MT), for a total of 1200 pulses
15736590|NCT04971681|Device|Sham|The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding.
15736591|NCT04971668|Other|Aromatherapy|Three drops of the designated blend aromatherapy (ginger & lavender) will be placed on a 2-inch by 2-inch impermeable, backed gauze pad and patient will be asked to inhale deeply and simulate like chewing gum for 5 minutes.
15736592|NCT04971668|Other|Gum Chewing|Patients will chew gum (sugar free) and inhale deeply with inert gauze for 5 minutes.
15736593|NCT04971668|Other|Controlled|Patients will inhale deeply with inert gauze and simulate like chewing gum for 5 minutes.
15736594|NCT04971655|Other|Music therapy|Music therapy will be applied throughout diabetes education. Turkish Folk, Classical, Turkish Art and Sufi Music genres will be offered to individuals as an option and will be listened to throughout the process. Instrumental works will be uploaded to the computer by the researchers and will be played on the loudspeaker during the training.
15736595|NCT04971642|Device|Intraoral ultrasound|Intraoral ultrasound scanning of the periodontium complex
15736596|NCT04971616|Other|Demographic data and range of motion.|The body parameters (BMI, age, gender), daily activities (daily steps, sedentary), work and rest time (sleep time, quality) were collected through wearable devices. The range of motion of neck and waist was collected through hand-held devices.
15736649|NCT04971265|Behavioral|Low SES/ Low Supports|Participants will read the following scenario: Michael and Kim are a young couple living with their 2-year-old child. Michael works as a janitor in a residential building, while Kim works as a cashier in a supermarket. Where they live, parents have 1 week of paid parental leave, full-day center-based daycare for children aged 0 to 3 is available for around $900 per month, full-day preschool for children aged 3 to 5 (early education programs to prepare for kindergarten) is available for around $1400 a month, and they can take parenting classes for $50 per hour.
15736597|NCT04971603|Other|Acupuncture|"All acupuncture operations were done by registered Chinese medicine practitioner. Sterile, disposable acupuncture needles (0.25mmin diameter and 40mmin length) were used, which were purchased from HuaTuo acupuncture instrument.
~Principal points: Neiguan (PC 6) *, Sanyinjia (SP 6) *, Weizhong (BL 40) *, Baihui (GV 20), Shuigou (GV 26) *, Zusanli (ST 36) *, Quchi (LI 11) *, Waiguan (TE 5) *, Hegu (LI 4) *, Huantiao (GB 30) *, Yanglingquan (GB 34)* (Grading of recommendation: C, level of evidence: IV).
~Supplementary points: If upper limbs hemiplegia occurs, add Jianliao (TE 14) and Shousanli (LI 10); if lower limbs hemiplegia occurs, add Xuanzhong (GB 39) and Taichong (LR 3); if a deviation of the mouth or tongue occurs, add Dicang (ST 4) and Jiache (ST 6)."
15736598|NCT04971590|Other|Participant completed survey|Participants will be required to complete the participant survey.
15736599|NCT04971590|Other|Medical chart review|Data will be collected from medical charts of participants.
15736600|NCT04971577|Drug|Simvastatin 40mg|participants will receive a capsule containing 4 tablets simvastatin 10 mg (40 mg total) every 24 hours at night
15736601|NCT04971564|Other|Blood sampling|Blood sampling will be made to Day 0, Day 3 and to 3 month after inclusion
15736602|NCT04971551|Drug|Jaktinib Hydrochloride Tablets|Oral on an empty stomach
15736603|NCT04971538|Diagnostic Test|OraQuick® HCV Self-Test|The OraQuick® HCV Self-Test is a lateral flow rapid diagnostic that can detect anti-HCV antibodies in oral fluid. Instructions for Use (IFU) for OraQuick® HCV Rapid Antibody Self-Test have been developed in Georgian for the previous 2 studies conducted in Georgia using the OraQuick® HCV Rapid Antibody Self-Test. The IFU has been optimized taking in the feedback on the IFU resulting from the aforementioned studies. As this HCV test is not approved for self-test use in Georgia, all tests will be labelled as Research Use Only (RUO) and test results will not be used for patient management.
15736604|NCT04971512|Drug|EDP-721|Oral administration (Part 1)
15736605|NCT04971512|Drug|Placebo (Part 1)|Placebo to match EDP-721, oral administration (Part 1)
15736606|NCT04971512|Drug|EDP-721 (Part 2)|Oral administration (Part 2)
15736607|NCT04971512|Drug|Placebo (Part 2)|Placebo to match EDP-721 (Part 2)
15736608|NCT04971512|Drug|EDP-514|Oral administration
15736609|NCT04971512|Drug|Placebo (Part 2)|Placebo to match EDP-514
15736610|NCT04971499|Drug|Dapansutrile|500 mg tablet
15736611|NCT04971499|Drug|Pembrolizumab|Single-use vial containing 100 mg/4 mL of pembrolizumab
15736612|NCT04971486|Behavioral|Motor Sequence Task|"Participants will be seated at a laptop with the right hand on a standard joystick. The movement of the joystick will move a cursor on the computer screen. Targets will appear on the laptop screen as a circle in one of twelve spatially distinct locations. The learner must move the joystick cursor to inside the target before the next target will appear."
15736613|NCT04971473|Biological|rhTSH|Scanning was done 48 hours after the radioiodine administration. Each patient was scanned first following rhTSH and then scanned after thyroid hormone withdrawal.
15736614|NCT04971447|Drug|gender affirming hormonal treatment in transgender men|testosterone enanthate
15736615|NCT04971447|Drug|gender affirming hormonal treatment in transgender women|GnRH agonists + estrogen
15736616|NCT04971434|Device|laser stimulation for acupoints|In fatty liver patients (30 patients), a daily application of 4-minute laser (for one month, except Fridays) on acupoint number 25,40,36 of stomach meridian, acupoint number 3 of liver meridian, acupoint number 6 of spleen meridian,acupoint number 9,12,4 of conception vessel meridian, acupoint number 14 of governor vessel meridian, acupoint number 4, 11 of large intestine meridian, acupoint number 34 of gall bladder meridian
15736617|NCT04971434|Other|cupping with scarification|In fatty liver patients (30 patients),every-two-week applied cupping (with scarification) session within one month on back of upper thorax
15736618|NCT04971421|Diagnostic Test|ctDNA - circulating tumor DNA|lcWGS and WGS of circulating tumor DNA
15736619|NCT04971421|Diagnostic Test|TEP - Tumor Educated Platelets|sequencing miRNA from TEPs
15736620|NCT04971408|Other|passive heat stress|as above
15736621|NCT04971408|Other|control|participant engage in activity as usual
15736622|NCT04971395|Drug|XTMAB-16 2mg/kg|Biological XTMAB-16 IV infusion single dose
15736623|NCT04971395|Drug|Placebo|Placebo; IV infusion single dose
15736624|NCT04971395|Drug|XTMAB-16 4mg/kg|Biological XTMAB-16 IV infusion single dose
15736625|NCT04971382|Drug|Curcumin|Curcumin (1,7-bis(4-hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5-dione) or diferuloylmethane is an important bioactive constituent and hydrophobic polyphenol that isolated from the rhizome of the turmeric plant (Curcuma longa) . Curcumin will be used in combination with xenograft after ridge splitting surgery
15736626|NCT04971369|Diagnostic Test|89Zr-NY001|89Zr-NY001 injection followed by 89Zr-NY001 PET scan
15736627|NCT04971356|Drug|Aspirin 100mg for 1-month (immediately after PCI)|Aspirin for 1-month immediately after PCI to be a part of medication treatment in the Experimental arm
15736628|NCT04971356|Drug|Ticagrelor 90mg for 6-month (immediately after PCI)|Ticagrelor for 6-month immediately after PCI to be a part of medication treatment in the Experimental arm
15736629|NCT04971356|Drug|Aspirin 100mg for 6-month (6-month post PCI)|Aspirin for 6-month at 6 months post-PCI (after the discontinuation of the 6-month Ticagrelor treatment) to be a part of medication treatment in the Experimental arm
15736630|NCT04971356|Drug|Aspirin 100mg for 12-month (immediately after PCI)|Aspirin for 12-month immediately after PCI to be a part of medication treatment in the Reference arm
15736631|NCT04971356|Drug|Ticagrelor 90mg for 12-month (immediately after PCI)|Ticagrelor for 12-month immediately after PCI to be a part of medication treatment in the Reference arm
15736632|NCT04971343|Diagnostic Test|Access HIV_blood donor|"Samples will be tested with both reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective IFU to determine non-reactive, initially reactive, and repeatedly reactive. Reference assay will be Roche - Cobas - Elecsys® HIV Duo .
~All initially reactive specimen results will be tested in duplicate per IFU .
~All RR specimens will be confirmed using testing including ImmunoBlot, Western Blot or HIV-1/HIV-2 differentiation test and HIV-1 PCR, RNA (if Immunoblot, WesternBlot or differentiation test is negative or indeterminate; if Immunoblot, WesternBlot or differentiation test is positive for HIV-2 then HIV-1 PCR will not be tested)."
15736699|NCT04970940|Drug|Treatment A|AJU-A51R1: Farxiga 1 Tab., Q.D., single dose, for 5 days
15736700|NCT04970940|Drug|Treatment B|AJU-A51R2: Trajenta 1 Tab., Q.D., single dose, for 11 days
15736633|NCT04971343|Diagnostic Test|Access HIV_Hospitalized patient|"All samples will be tested with both reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective IFU to determine non-reactive, initially reactive, and repeatedly reactive. Reference assay will be Abbott Architect HIV Ag/Ab combo assay for hospitalized patient.
~All initially reactive specimen results will be tested in duplicate per IFU .
~All RR specimens will be confirmed using testing including ImmunoBlot, Western Blot or HIV-1/HIV-2 differentiation test and HIV-1 PCR, RNA (if Immunoblot, WesternBlot or differentiation test is negative or indeterminate; if Immunoblot, WesternBlot or differentiation test is positive for HIV-2 then HIV-1 PCR will not be tested)."
15736634|NCT04971343|Diagnostic Test|Access HIV_known HIV-1 antibody positives|"Samples will be tested with both reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective IFU to determine non-reactive, initially reactive, and repeatedly reactive. Reference assay will be Abbott Architect HIV Ag/Ab combo assay .
~All initially reactive specimen results will be tested in duplicate per IFU .
~For the known positive cohorts (sensitivity cohorts), samples will be identified as positive at enrollment/time of testing according to inclusion criteria prior to testing or in parallel of testing with Access and Reference HIV Ag/Ab combo assays.
~In case of discrepant results or concordant negative results between Access and Reference HIV Ag/Ab combo assay among known HIV-1 antibody positive patients, the IB/WB test will be repeated by the site to confirm sample status. If this IB/WB result is negative or indeterminate, the sample will be excluded from the statistical analysis"
15736635|NCT04971343|Diagnostic Test|Access HIV_known HIV-2 antibody positives|"Samples will be tested with both reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective IFU to determine non-reactive, initially reactive, and repeatedly reactive. Reference assay will be Abbott Architect HIV Ag/Ab combo assay.
~All initially reactive specimen results will be tested in duplicate per IFU .
~For the known positive cohorts (sensitivity cohorts), samples will be identified as positive at enrollment/time of testing according to inclusion criteria prior to testing or in parallel of testing with Access and Reference HIV Ag/Ab combo assays."
15736636|NCT04971343|Diagnostic Test|Access HIV_known HIV-1 p24 Ag positive|"All samples will be tested with both Reference HIV Ag/Ab combo assay and Access HIV Ag/Ab combo assay according to respective IFUs/study guide to determine non-reactive (NR), initially reactive (IR), and repeatedly reactive (RR). Reference assay will be Abbott - ARCHITECT HIV Ag/Ab Combo Assay.
~Due to volume constraints, all known HIV-1 p24 Ag positive samples that will be tested during the EU HIV clinical trial will be tested in singulare only with the Reference HIV Ag/Ab combo assay, and in singulare and then in duplicate if IR with Access HIV Ag/Ab combo assay.
~For the known positive cohorts (sensitivity cohorts), samples will be identified as positive at enrollment/time of testing according to inclusion criteria prior to testing or in parallel of testing with Access and Reference HIV Ag/Ab combo assays"
15736637|NCT04971343|Diagnostic Test|Access HIV_Canada's requirements_Blood donor|"To fit with Canada's requirements:
~4,000 additional blood donor samples from geographically distinct regions will be collected and tested. Blood donor sample testing will be equally distributed over three blood donor sites, using 3 different lots of reagents: the first 2,000 blood donor samples from CE-marking study (out of the 6,000 tested) will be used plus the 4,000 additional blood donor samples.
~Retesting of 1000 blood donor samples will be done internally with 1 lot close to expiration to satisfy Canadian requirements"
15736638|NCT04971343|Diagnostic Test|Access HIV_Canada's requirements_HIV positive|"To fit with Canada's requirements:
~o HIV positive samples will be equally distributed and tested at leat three (3) testing sites, using 3 lots of reagents."
15736639|NCT04971343|Diagnostic Test|Access HIV_Canada's requirements_P24 Positive|"To fit with Canada's requirements:
~HIV positive samples will be equally distributed and tested at leat three (3) testing sites, using 3 lots of reagents.
~Collection and testing of maximum 210 additional HIV-1 Ag positive sample beyond the 50 required by CTS"
15736640|NCT04971330|Diagnostic Test|Access HCV|"All samples were tested with both reference anti-HCV assay and Access anti-HCV assay according to respective instructions for use (IFU) or study guide, as applicable, to determine non-reactive (NR), initial reactivity, and repeat reactivity. Reference assay was Abbott Architect anti-HCV assay. For blood donors, Abbott PRISM HCV was used as reference.
~For the specificity cohorts (blood donor and hospitalized patient samples), all HCV Ab positive results will have supplemental confirmation testing with HCV Immunoblot for final HCV Ab status"
15736641|NCT04971317|Behavioral|Sugar-Sweetened Beverage (SSB) Video|Participants will watch a video showing the decay of an egg in various SSBs (Coca-Cola, Sprite, Gatorade, and apple juice), followed by the evaporation of these beverages over a heat source, revealing their sugar content.
15736642|NCT04971317|Behavioral|Water Video|Participants will watch a video showing an egg maintaining its shell in water, followed by the evaporation of water.
15736643|NCT04971317|Behavioral|Control|Participants will watch a video of an egg maintaining its shell in rubbing alcohol, followed by the evaporation of rubbing alcohol.
15736644|NCT04971304|Drug|Receipt of granulocyte-colony stimulating factor|Receipt of originator or biosimilar
15736645|NCT04971291|Drug|AXS-05|AXS-05 taken twice daily for 6 weeks
15736646|NCT04971291|Drug|Bupropion SR|Bupropion taken twice daily for 6 weeks
15736647|NCT04971278|Behavioral|Supportive care program|Community Health Workers, a home visiting doctor service, a supportive care nurse, and behavioral health specialist engage the population to address a range of biopsychosocial needs with end goal in increasing support in the community and engaging palliative and hospice care when appropriate to prevent hospital readmissions, shorten length of stay, reduce hospital utilization, and decrease overall patient cost with a focus on hospital spend.
15736648|NCT04971265|Behavioral|Low SES/High Supports|Participant will read the following scenario: Michael and Kim are a young couple living with their 2-year-old child. Michael works as a janitor in a residential building, while Kim works as a cashier in a supermarket. Where they live, all parents have 12 weeks of paid parental leave, access to free full-day center-based daycare for children aged 0 to 3, free full-day preschool for children aged 3 to 5 (early education programs to prepare for kindergarten), and free parenting classes.
15736650|NCT04971265|Behavioral|High SES/High Supports|Participants will read the following scenario: Michael and Kim are a young couple living with their 2-year-old child. Michael works as a lawyer in a private company, while Kim works as a manager at a bank. Where they live, all parents have 12 weeks of paid parental leave, access to free full-day center-based daycare for children aged 0 to 3, free full-day preschool for children aged 3 to 5 (early education programs to prepare for kindergarten), and free parenting classes.
15736651|NCT04971265|Behavioral|High SES/Low Supports|Participants will read the following scenario: Michael and Kim are a young couple living with their 2-year-old child. Michael works as a lawyer in a private company, while Kim works as a manager at a bank. Where they live, parents have 1 week of paid parental leave, full-day center-based daycare for children aged 0 to 3 is available for around $900 per month, full-day preschool for children aged 3 to 5 (early education programs to prepare for kindergarten) is available for around $1400 a month, and they can take parenting classes for $50 per hour.
15736652|NCT04971252|Diagnostic Test|Hematologic tests for patients with diabetes mellitus and chronic kidney disease|Study basic coagulation profile and platelet indices among diabetic patients with chronic kidney disease
15736653|NCT04971239|Drug|topical methotrexate micoemulsion|The selected microemulsion composition consists of 40% Jojoba oil, 45% Tween-80 and Span-85 at a ratio of 3:1 as surfactant and co surfactant, respectively and 15% water. The chosen concentration was based on preliminary studies conducted which delineated that these ratios provided the best skin deposition based on factorial skin modelling.The prepared microemulsions contains 0.1% methotrexate
15736654|NCT04971239|Device|Excimer light|the excimer laser will be done twice weekly for a total treatment course of 12 weeks.
15736655|NCT04971239|Device|Narrow band ultraviolet B|the Narrow band ultraviolet B will be done twice weekly for a total treatment course of 12 weeks.
15736661|NCT04971213|Device|Non invasive ventilation|Emergency and transport ventilator (Monnal T60, Airliquide, Antony, France)
15736662|NCT04971213|Device|High-flow nasal cannula heated and humidified oxygen|AirVO2 device (Fisher and Paykel, New Zealand)
15736663|NCT04971200|Drug|Tildrakizumab|2 100mg subcutaneous injections Q4W
15736664|NCT04971187|Drug|Bintrafusp Alfa|Given IV
15736665|NCT04971187|Drug|Pemetrexed|Given IV
15736666|NCT04971187|Drug|Carboplatin|Given IV
15736667|NCT04971187|Drug|Cisplatin|Given IV
15736670|NCT04971148|Other|HFNC flow set at patient peak tidal inspiratory flow|HFNC flow will be set at the level equal to patient peak tidal inspiratory flow
15736671|NCT04971148|Other|HFNC flow set at 1.33 times of patient peak tidal inspiratory flow|HFNC flow will be set at 1.33 times of patient peak tidal inspiratory flow
15736672|NCT04971148|Other|HFNC flow set at 1.67 times of patient peak tidal inspiratory flow|HFNC flow will be set at 1.67 times of patient peak tidal inspiratory flow
15736673|NCT04971148|Other|HFNC flow set at 2 times of patient peak tidal inspiratory flow|HFNC flow will be set 2 times of patient peak tidal inspiratory flow
15736674|NCT04971135|Drug|SAN711|SAN711 liquid formulation
15736675|NCT04971135|Other|Placebo|Matching placebo
15736677|NCT04971109|Drug|TPOXX|Study is based on Animal Regulatory Rule
15736678|NCT04971109|Other|TPOXX Placebo|Does not apply
15736679|NCT04971096|Dietary Supplement|PS23 live|PS23 belongs to Lactobacillus paracasei group.Probiotic capsules contain 10 billion CFU (colony forming units) of PS23
15736680|NCT04971096|Dietary Supplement|PS23 heat-treated|The PS23 heat-treated probiotic capsule contain 10 billion of PS23 cells.
15736681|NCT04971096|Dietary Supplement|Placebo|The placebo capsule contains microcrystalline cellulose.
15736682|NCT04971083|Behavioral|Intervention Group|This study is designed to provide patients a tool with which they can record the nutrition related symptom burden (NRSB) they are experiencing in real time. A pre-defined algorithm then provides them with tailored nutrition information and behavioural tipps based on the severity grade of the symptom recorded. The aim is to increase the chances that such symptoms, when clinically relevant, are addressed in a timely matter and thus the nutrition status is stabilized.
15736683|NCT04971070|Other|Observation and follow-up|Observation and follow-up study
15736684|NCT04971057|Other|multimedia information program of renal biopsy|Multimedia information program is based on self-efficacy theory. The multimedia videos contain the information associated with renal biopsy, which including the purpose, indications, preparations for the examination, process, patient experience sharing, complications, precautions, home care and stress adjustment strategies.
15736687|NCT04971031|Drug|Reproxalap Ophthalmic Solution (0.25%)|Reproxalap Ophthalmic Solution (0.25%) administered 7 times over two consecutive days.
15736688|NCT04971031|Drug|Vehicle Ophthalmic Solution|Vehicle Ophthalmic Solution administered 7 times over two consecutive days.
15736689|NCT04971018|Device|Auricular vagus nerve stimulation|Patients will have 20-minutes stimulation sessions at home twice a day during 3 months.
15736690|NCT04971018|Device|Sham Auricular vagus nerve stimulation|Patients will have 20-minutes stimulation sessions at home twice a day during 3 months.
15736691|NCT04971005|Drug|Autologous Hematopoietic Stem Cell Transplantation|Autologous Hematopoietic Stem Cell Transplantation
15736692|NCT04971005|Drug|Ocrelizumab|600 mg every 6 months continuously
15736693|NCT04971005|Drug|Alemtuzumab|12 mg/day for 5 consecutive days and again after 365 days for 3 days
15736694|NCT04970992|Drug|DZ-002|DZ-002 Injection
15736695|NCT04970979|Other|survey|questionnaire about the influencing factors of home-based cardiac rehabilitation
15736696|NCT04970966|Device|PuraSinus|A randomized ethmoid cavity in the patient will have PuraSinus applied to the ethmoid cavity after completion of an endoscopic total ethmoidectomy.
15736697|NCT04970966|Device|Bioresorbable Nasal Dressing|PosiSep X will be applied to the ethmoid cavity after completion of an endoscopic total ethmoidectomy.
15736701|NCT04970940|Drug|Treatment C|AJU-A51R1 1 Tab. and AJU-A51R2 1 Tab., Q.D., co-administration for 5 days
15736702|NCT04970914|Drug|Anlotinib|12mg, continuous oral 2 weeks stop for 1 week, 21 days for a treatment cycle.
15736703|NCT04970914|Drug|Penpulimab|Penpulimab 200 mg administered intravenously every 3 weeks.
15736704|NCT04970901|Drug|Loncastuximab Tesirine|Intravenous (IV) infusion
15736705|NCT04970901|Drug|Gemcitabine|Intravenous (IV) infusion
15736706|NCT04970901|Drug|Lenalidomide|Orally via capsules
15736707|NCT04970901|Drug|Polatuzumab Vedotin|Intravenous (IV) infusion
15736708|NCT04970901|Drug|Umbralisib|Orally via tablets
15736709|NCT04970888|Other|Cognitive training|"The cognitive training will involve attention control training and memory training, with thrice-weekly 30-min sessions.
~Two of these sessions will involve computer or tablet-based attentional control training targeting dual-tasking, updating and working memory, as well as inhibition and switching. Difficulty of cognitive training will be tailored to participants' performances. The remaining session will consist of memory training. Participants will be instructed mnemotechnic, as well as be taught about memory in aging in general."
15736710|NCT04970888|Other|Exercise training|Participants will follow a 20-week physical training program, with 60-min thrice-weekly trainings. The training sessions will start with a 5-min warm-up, followed by an aerobic training (20 min) after which 20-min of resistance/muscular training will take place. The program will end with a 10-min cool-down. Training will be adapted to individuals' baseline capacity as measured by the baseline cardiorespiratory test. For home-training sessions, participants will have access to a complete exercise training program. A certified kinesiologist will supervise trainings. With the Heart rate sensor Polar H10, all the characteristics of the activities will be recorded (type of the activity, intensity, heart rate, duration). A kinesiologist will call participants every week to ensure the smooth running of the exercises training sessions and individualize the care according to the patient's level.
15736711|NCT04970888|Other|Usual care|All patients will receive usual care and be treated according to evidence-based treatments. This will include optimal medical therapy, systematic information regarding dietary and fluid management, and a recommendation for regular physical activity consistent with the latest update of the Canadian Cardiovascular Society Guidelines for the Management of Heart Failure. Moreover, patients who benefit from a prescription for a cardiovascular rehabilitation program will be able to follow it, but they will not receive other forms of intervention for the duration of the study.
15736712|NCT04970875|Other|Questionnaire|QoL questionnaire
15736713|NCT04970862|Procedure|reversion surgery|reversion surgery
15736714|NCT04970849|Other|observation|IBD doctors who perform the endoscopy perform the questionnaire
15736715|NCT04970836|Biological|recombinant hepatitis B vaccine|Hepatitis B vaccine (Engerix-B) will be administered to the eligible participants by 4 groups. Each case will be tracked for 12 months, at 0, 7-10 days, 28 days, 24-28 weeks, 48-52 weeks anti-HBs titer concentration and 4 follow-up questionnaires.
15736716|NCT04970823|Device|The somatosensory interactive game for preschool children|The somatosensory interactive game, an independent nursing intervention, promotes pain relief for preschool children.
15736717|NCT04970823|Device|A VR (virtual reality) game for school-age children|A VR (virtual reality) game environment promotes pain relief for school-age children.
15736718|NCT04970810|Behavioral|My Diabetes Goal|Subjects enrolled in the MDG arm will receive surveys at baseline, 6 months and 12 months, followed by monthly diabetes care management phone calls.
15736719|NCT04970810|Behavioral|My Diabetes Goal + CommunityRx|"Subjects enrolled in the MDG arm + CRx will receive surveys at baseline, 6 months and 12 months, followed by monthly diabetes care management phone calls. Participants will also receive a HealtheRx (personalized resource prescriptions) for community organizations."
15736720|NCT04970797|Drug|Xinglouchengqi decoction|the composition of Xinglouchengqi decoction: 9 g raw rhubarb, 9 g mirabilite, 6 g dananxing, 30 g quangualou decoction was uniformly prepared by the pharmacy department of our hospital. Decoction form was adopted, one dose per day, one dose of 200 mL decoction, and the decoction was taken in morning and evening twice and half an hour after meals. The observation period was 5 days: from 72 hours to 7 days after onset.
15736721|NCT04970784|Other|Activities of Daily Living (ADL) questionnaire (The Katz index )|"For patients cared for by the geriatric sector, questionnaire will be filled in at admission D0 and by phone at D30, for the classic emergency patients questionnaire will be submitted by phone the day following the consultation D1, and D30."
15736722|NCT04970771|Behavioral|Solving Wellness platform|Interactive wellness resources available include a wide range of curated content and resources including fitness and yoga classes, cooking classes, webinars on sleep and various mental health topics including resilience, stress management, relationships and mindfulness, and resources including e-books, videos and guided meditations. Online discussion groups will foster awareness for specific issues and allow casual discussion. A curated collection of links to additional resources including the Solving Healthcare podcast will also be provided.
15736723|NCT04970745|Other|Transcranial parenchymal color Doppler ultrasound (TCS)|tracing the nigrostriatal echogenic area
15736724|NCT04970745|Other|Electromyography (EMG) tremor analysis|observed 1, frequency 2, amplitude (amplitude) 3, correlation between the two sides 4, load and post-drug test differences
15736725|NCT04970732|Procedure|Gum chewing|The patients in the experimental group returned to the ward for general anesthesia, started to wake up for 2 hours, chewed xylitol gum, and the professional nurses distributed it on time every 2 hours on the operation day, then 3 times / day, 15-20 minutes / time, 2 tablets / time. Body position: lateral position. The first anal exhaust stop chewing, normal sleep at night (8 p.m.), do not chew gum. Gum waste must be identified
15736726|NCT04970719|Drug|Baricitinib|4 mg of baricitinib administered as 2 tablets taken orally daily while hospitalized for up to a 14-day total course
15736727|NCT04970719|Drug|Dexamethasone|and 6 mg* of dexamethasone administered as an intravenous injection daily while hospitalized for up to a 10-day total course
15736728|NCT04970719|Drug|Remdesivir|200 mg of remdesivir administered intravenously on Day 1, followed by a 100 mg once-daily maintenance dose of remdesivir while hospitalized for up to a 5-day total course
15736729|NCT04970706|Procedure|ACL reconstruction|All patients will undergo a standardized single-bundle technique with a hamstring or bone-patellar tendon-bone autograft.
15736769|NCT04970381|Drug|Rivaroxaban|Patients with ventricular mural thrombus in the study receive rivaroxaban anticoagulant therapy for 12 weeks
15736730|NCT04970693|Drug|Furmonertinib|The different dose of furmonertinib will be given according to the generation of EGFR-TKI used as the first-line therapy. The doses and target volume of radiotherapy will be decided according to the oligoprogressive sites.
15736731|NCT04970680|Procedure|glossopharyngeal nerve block|glossopharyngeal nerve block either blindly or using the ultrasonic technique
15736732|NCT04970667|Drug|Flupentixol melitracen tablets|Patients were treated with Flupentixol and melitracen tablets for 12 weeks
15736735|NCT04970641|Behavioral|Three Good Things (3GT) Positive Psychology journaling activity|Evening journaling activity each day to reflect on three good things that the subject has noticed about their day's events.
15736736|NCT04970628|Other|Medical records collection|Patient's medical records before and after surgery.
15736737|NCT04970615|Device|Three-dimensional printed model|Three-dimensional printers are able to print physical objects in real size and colours. As a respresentative of the real tumor, a personalized three-dimensional model enables visualization of the patient-specific tumor and eloquent areas.
15736738|NCT04970602|Drug|Methylene Blue|Once the patient meets inclusion criterial, the interventional group will receive 2mg/kg methylene blue infusion within 20min, followed by 0.5mg/kg/h for 4 hours.
15736739|NCT04970589|Other|Mango|400g of mango/day
15736740|NCT04970589|Dietary Supplement|Probiotics|1 probiotics capsule/day
15736741|NCT04970589|Other|Placebo|1 Placebo capsule/day
15736742|NCT04970576|Drug|Rivaroxaban|Dose of 20 mg once a day for three months followed by transthoracic echocardiographic assessment for presence/absence of LV thrombus after 4 weeks and 12 weeks
15736743|NCT04970576|Drug|Warfarin|Dose as per the target INR of 2 to 3 with transthoracic echocardiographic assessment for presence/absence of LV thrombus after 4 weeks and 12 weeks
15736744|NCT04970563|Other|Body odor samples|Participants will provide six body odor samples (mask and sweat samples) at inclusion
15736745|NCT04970563|Other|Body odor samples|Participants will provide six body odor samples (masks and compresses) at inclusion. A 7-day follow-up will be carried out to check, respectively, the absence of symptoms and the persistence of negativity on the SARS-COV-2 PCR test
15736746|NCT04970550|Other|Non intervention|Non intervention
15736747|NCT04970524|Procedure|Comparison of conventional free gingival graft versus partial free gingival graft|"Conventional free gingival graft was applied to the area of the patient with attached gingival insufficiency determined by randomization.
~Clinical and aesthetic comparisons were made in the postoperative 1st, 3rd and 6th months."
15736748|NCT04970524|Procedure|Comparison of conventional free gingival graft versus partial free gingival graft|"Partially de-epithelialized free gingival graft was applied to the other region of the patient with attached gingival insufficiency determined by randomization.
~Clinical and aesthetic comparisons were made in the postoperative 1st, 3rd and 6th months."
15736749|NCT04970511|Behavioral|BBAT (Basic Body Awareness Therapy)|The group I: BBAT Face-to-Face Training (60 min) will be provided.
15736750|NCT04970511|Behavioral|Online BBAT training|The group II: Online BBAT training (60 min) will be provided.
15736751|NCT04970498|Diagnostic Test|MRI|MRI including T1WI, DWI sequence and IDEAL-IQ sequence before radiotherapy, 1-2 weeks after radiotherapy and 90 days after radiotherapy were performed
15736752|NCT04970498|Diagnostic Test|blood routine test|The blood routine was collected before radiotherapy, 1 week, 2 weeks and 90 days after radiotherapy.
15736753|NCT04970485|Behavioral|Talking Matters|Group-level, facilitator-led behavioral intervention for 14-19 year old Black and African American adolescents with an intergenerational component to reduce teen pregnancy, strengthen protective factors to improve optimal health, and increase access to trusted adults.
15736754|NCT04970472|Biological|collection of blood, urines, stool and tumor samples|blood, urines, stool will be collected during routine cares. Tumor samples from surgery will also be stored.
15736755|NCT04970459|Biological|collection of samples of blood and urine|extra samples of blood and urine will be collected and stored for research utilisation
15736756|NCT04970446|Drug|Antibiotics|All patients will receive a one week course of antibiotic therapy.
15736757|NCT04970446|Dietary Supplement|Dietician designed diet|All patients will be recommended dietary modification 3 weeks prior to, and during, the study.
15736758|NCT04970446|Drug|FMT|Anaerobically prepared stool. Dosing will vary according to mode of administration.
15736759|NCT04970446|Other|Placebo|Placebo will contain food colourant, 0.9% normal saline and glycerol.
15736760|NCT04970433|Procedure|Electroacupuncture (EA)|Acupuncture at Hegu (LI4), Neiguan (PC6), Zusanli (ST36), Sanyinjiao (SP6) and Sishencong (EX-HN1). Electrical stimulation with a pair of electrodes connecting on LI4/PC6 and ST36/SP6.
15736761|NCT04970433|Procedure|Laser acupuncture (LA)|The laser applies to each point for 40 seconds, which delivers 3 J of energy at each of the acupoints as those in electroacupuncture group.
15736762|NCT04970433|Procedure|Sham laser acupuncture (SLA)|The laser device without any laser output applies on the acupoints the same as those in the LA group.
15736763|NCT04970420|Other|Health Responsibility and Family Planning ın Immigrant Women (Ahıska Turks).|In this study, individual training, training via mobile application and telephone counseling will be given to the experimental group. During the meetings, attention will be paid to the pandemic rules.
15736764|NCT04970420|Other|Control group|Individual training, mobile application and telephone counseling will be given to the control group after the study data is collected.
15736765|NCT04970407|Biological|Botulinum toxin type A|Intramuscular Injection, concentration 300 units (U)
15736766|NCT04970407|Biological|Botulinum toxin type A|Intramuscular Injection, concentration 50 U
15736767|NCT04970407|Biological|Botulinum toxin type A|Intramuscular Injection, concentration 50 U
15736768|NCT04970394|Behavioral|Cervical Screening Reminder|Verbal reminder and if seen face-to-face, a written appointment booking slip.
15736770|NCT04970368|Procedure|Sentinel node procedure|Excision of ALL mapped nodes and other suspicious nodes regardless of mapping and label by anatomic location
15736771|NCT04970368|Procedure|Selective staging|Intraoperative consultation (IOC)
15736772|NCT04970355|Biological|Erenumab|Pre-filled syringe; s.c. injection
15736773|NCT04970355|Drug|Placebo|Pre-filled syring; s.c. injection
15736774|NCT04970342|Drug|Placebo (Lactose) Capsule|Single dose on two of the three study visits, orally administered 40 minutes prior to cannabis dose
15736775|NCT04970342|Drug|0.75 mg Alprazolam Capsule|Single dose on one of the three study visits, orally administered 40 minutes prior to cannabis dose
15736776|NCT04970342|Drug|Cannabis (6.18% THC / <0.025% CBD)|Cannabis vapor is produced from 500 mg of dried plant material (6.18% THC / <0.025% CBD). Subjects will inhale using the Foltin Puff Procedure over 10 minutes. Single inflated bag/dose consumed via inhalation 40 minutes after alprazolam dose on one of the three study visits.
15736777|NCT04970342|Drug|Cannabis (0%/ THC / 0% CBD)|Cannabis vapor is produced from 500 mg of dried plant material (0% THC / 0% CBD). Subjects will inhale using the Foltin Puff Procedure over 10 minutes. Single inflated bag/dose consumed via inhalation 40 minutes after alprazolam dose at two of the three study visits.
15736778|NCT04970329|Drug|Polyethylene Glycol 400 0.4%-Propylene Glycol 0.3%. and Dextran 0.1%Hypromellose 0.3%,|Drugs will be given to two group and third group will kept on placebo.
15736779|NCT04970303|Drug|Methylphenidate|Retina or Concerta
15736781|NCT04970277|Other|drinking water group|Those randomized to drink water group were asked to drink 200 mL colorless water every 10 minutes, starting at the time of capsule ingestion until three times in total.
15736782|NCT04970277|Other|control group|Those randomized to control group were asked not to drink extra water after capsule ingestion.
15736783|NCT04970251|Drug|Aflibercept Ophthalmic|Panretinal photocoagulation and intravitreal aflibercept (2 mg/0.05 ml) injection were given, and trabeculectomy with mitomycin C was performed within 2 weeks after intravitreal aflibercept injection.
15736784|NCT04970238|Drug|Levosimendan|Test drug: drug preparation method: 5ml (12.5mg) levosimendan injection was mixed with 500ml 5% glucose injection, the initial loading dose was 6 µg / kg for 10 minutes, followed by continuous infusion of 0.1 µg/ kg / min for 24 hours.
15736785|NCT04970238|Other|placebo|Control drug: 5% glucose injection, intravenous injection method is the same as the experimental group pump dose, the initial load dose of treatment is 6 µg / kg for 10 minutes, followed by continuous infusion of 0.1 µg / kg / min for 24 hours.
15736786|NCT04970225|Other|1 blood sample|4 tubes of 7 ml per sample (a single sample)
15736787|NCT04970225|Other|2 blood samples|4 tubes of 7 ml per sample / 2 samples : before / after antibiotic treatment
15736788|NCT04970212|Device|BioTraceIO Lite|The BioTraceIO software will analyze the ultrasound images, and provide the physician with an estimated tissue damage map.
15736789|NCT04970199|Device|laser application on acupoints|laser acupuncture
15736790|NCT04970173|Other|use of a very low-volume 1L-PEG plus ascorbate (plenvu) or low-volume 2L-PEG plus ascorbate (moviprep) for bowel preparation in open access colonoscopy|Patients are free to choice the kind of BP in an open access booking system colonoscopy. The safety of BPs was assessed by reviewing the clinical and laboratory data of patients who attended the Emergency Department (ED) of the five Hospitals of our Digestive Endoscopy Unit in the 7 days following the colonoscopy. This was feasible since the electronic reporting system is the same across our five Hospitals.
15736791|NCT04970160|Procedure|TSARP|We make four different surgical operations for female patients with rectovestibular fistula
15736792|NCT04970160|Procedure|PSARP|Posterior sagittal anorectoplasty
15736793|NCT04970160|Procedure|Classic ASARP|Anterior Sagittal anorectoplasty
15736794|NCT04970160|Procedure|Modified ASARP|External anal sphincter preservation
15736795|NCT04970147|Other|Gastrostomy care bundle|Gastrostomy care bundle
15736796|NCT04970134|Other|Immunohistochemistry (IHC)|VENTANA pan-TRK technique (EPR17341) Assay, with Optiview DAB-detection kit and Optiview amplification kit. Using FFPE slices
15736797|NCT04970134|Other|Fluorescence In-Situ Hybridization (FISH)|FISH using FFPE slices for genes: Neurotrophic tyrosin kinase 1 (NTRK1), Neurotrophic tyrosin kinase 3 (NTRK3) and rearranged during transfection (RET)
15736798|NCT04970134|Other|Oncomine Focus Assay Platform with 52 genes|Oncomine Focus Assay Platform with 52 genes (35 Hotspot genes, 19 Copy number variants and 23 Gene fusions). Using FFPE slices
15736799|NCT04970121|Drug|Duloxetine|"Duloxetine, tablets, 20mg as starting dose and up to 60mg as maximum dose, once daily.
~Taxanes is used according to manual instruction and patient condition."
15736800|NCT04970108|Drug|Egito|EGITO Egito coated tablet. EMPAGLIFLOZIN PLACEBO Empagliflozin placebo coated tablet. TELMISARTAN PLACEBO Telmisartan coated tablet.
15736801|NCT04970108|Drug|Empagliflozin + telmisartan|Drug: EMPAGLIFLOZIN Empagliflozin 25 mg coated tablet. Drug: TELMISARTAN Telmisartan 40/80 mg coated tablet. EGITO PLACEBO Egito placebo coated tablet.
15736802|NCT04970095|Device|Maxillary Expander with Differential Opening (EDO)|The EDO is designed with two expansion screws positioned transversely. When more expansion is required between the canines, the anterior screw can be further activated. Both expansion screws can be activated to open in a parallel configuration. Pivoting corner screws allow for different amounts of expansion without significant risk of binding during activation.
15736803|NCT04970095|Device|Petit Face Mask|"The face mask is anatomical, multi-adjustable, lightweight and an ideal therapeutic alternative for the correction of Class III malocclusion.
~consist of forehead cap chin cap cross bar"
15736804|NCT04970082|Diagnostic Test|FFR DWP|FFR will be measured twice in the same lesion : 1 measurement of each method, one with the standard method and the other with the DWP method.
15736805|NCT04970082|Diagnostic Test|FFR|FFR will be measured twice in the same lesion : 1 measurement of each method, one with the standard method and the other with the DWP method.
15736806|NCT04970069|Other|Video on analgesic education|A four minute video informing the patient about opioids.
15736807|NCT04970069|Other|Video on general perioperative education|A four minute video informing the patient about general perioperative process.
15736808|NCT04970043|Drug|Camrelizumab+ pemetrexed + platinum|"Induction period: (4-6 cycles) Camrelizumab: a fixed dose of 200 mg, intravenous drip for 30-60 minutes, the first day, every 3 weeks as a cycle.
~Pemetrexed: 500 mg / m2, given on the first day, every 3 weeks as a cycle; Carboplatin: AUC = 4-5, given on the first day, every 3 weeks as a cycle; After 4-6 cycles of treatment, the patients entered the maintenance treatment period of carrizumab combined with pemetrexed.
~Maintenance treatment period:
~Camrelizumab: a fixed dose of 200 mg, intravenous drip for 30-60 minutes, the first day, every 3 weeks as a cycle.
~Pemetrexed: 500 mg / m2, given on the first day, every 3 weeks as a cycle; Every 3 weeks is a treatment cycle, and the drug is maintained until the following conditions occur: disease progression, intolerable toxicity, or receiving immunotherapy for no more than 35 cycles (2 years)."
15736809|NCT04970030|Procedure|ML lithotripsy|we will proceed under fluoroscopic vision with TTS mechanical lithotripter (Trapezoid, RX Wireguided Retrieval Basket, Boston Scientific) with mechanical fragmentation of the stone and subsequent complete cleaning of the biliary tract using the fluoroscopic technique.
15736810|NCT04970030|Procedure|EHL lithotripsy|after administration of IV antibiotic therapy, we will proceed to cholangioscopy with SpyGlass ™ DS (Boston Scientific Corporation, USA), treatment of difficult biliary lithiasis with electrohydraulic lithotripsy with Autolith probe (Northgate Technologies Inc USA) and subsequent complete cleaning of the biliary tract using the fluoroscopic technique
15736811|NCT04970017|Radiation|Cardiac MRI, Echocardiography|Magnetic resonance imaging, Echocardiography
15736812|NCT04970004|Other|No intervention|No study intervention will be administered as part of this study.
15736813|NCT04969991|Drug|Varespladib|250 mg immediate-release oblong, white, film-coated tablet for oral administration
15736814|NCT04969991|Drug|Placebo|Oral formulation matched to the oral varespladib tablet
15736815|NCT04969978|Behavioral|Enhanced Academic Detailing|"Group training of clinic staff prior to activation of the eReferral system and 12 months post-activation
~Follow-up booster sessions
~Monthly performance audit and feedback
~Written training materials for all providers and staff"
15736816|NCT04969978|Other|Informational Intervention|Receive overview of Quitline services and use of Quitline eReferral via online materials
15736817|NCT04969965|Drug|aumolertinib|EQ143 tablet is an oral solid dosage form manufactured at a strength of 55 mg. Each EQ143 tablet contains EQ143 drug substance, microcrystalline cellulose (KG802), anhydrous lactose (21AN), sodium carboxymethyl starch (type A), sodium stearyl fumarate and magnesium stearate (MF-2-V). EQ143 is orally administered once at a dose of 110 mg (two tablets) for each single dose.
15736818|NCT04969952|Other|For interventional module|Using vedio to assist physicians introducing advance care planning to cancer patients
15736823|NCT04969900|Other|Placebo oil|The placebo group will receive placebo oil.
15736824|NCT04969900|Other|Lavender oil.|Investigational Product. This group will receive Lavender oil.
15736825|NCT04969887|Drug|Ipilimumab|CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) is a key regulator of T cell activity. Ipilimumab is a CTLA-4 immune checkpoint inhibitor that blocks T-cell inhibitory signals induced by the CTLA-4 pathway, increasing the number of tumor reactive T effector cells which mobilize to mount a direct T-cell immune attack against tumor cells. CTLA-4 blockade can also reduce T regulatory cell function, which may lead to an increase in anti-tumor immune response.
15736826|NCT04969887|Drug|Nivolumab|A fully human immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death-1 (PD-1,PCD-1) with immune checkpoint inhibitory and antineoplastic activities. Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs (antigen presenting cells). This results in the activation of T-cells and cell-mediated immune responses against tumor cells or pathogens. Activated PD-1 negatively regulates T-cell activation and and plays a key role in in tumor evasion from host immunity.
15736827|NCT04969874|Other|Remote follow-up|"The feeling of swallowing will be assessed at the end of the stay at the rehabilitation center, which corresponds to the first visit, and then every month for 5 months during remote interviews and on discharge with the Deglutition Handicap Index (DHI), a self-assessment questionnaire for the swallowing handicap.
~The quality of life will be assessed at the firs visit and 6 months after using the EORTC QLQ 30 quality of life scale and the H&N annex, a self-assessment questionnaire on the quality of life for people with cancer of the head and neck.
~The satisfaction of users and the interest of city health professionals in the use of the MAX Educ tool as part of a monthly monitoring will be collected via the TUQ questionnaire, through the MAX platform at Month 6."
15736830|NCT04969848|Other|Wearable sensor|IMU sensor (as part of eMSGait device) worn at the hip during T25FW
15736832|NCT04969822|Device|iDAScore®|A system that studies time lapse images obtained from the embryo culture system, Embryoscope, throughout the development to blastocyst. The system uses data acquired from a sequence of embryo images and has taught itself to identify the embryos with the highest likelihood of implanting and leading to fetal heart-beat detection.
15736833|NCT04969809|Diagnostic Test|Ultrasound of the jugular veins|Ultrasound of the jugular veins to assess the thickness of the carotid intima media
15736834|NCT04969809|Dietary Supplement|addition of phenylalanine-free protein substitutes|addition of phenylalanine-free protein substitutes for sufficient daily intake of essential amino acids and other vitamins and minerals and nutritional plan
15736835|NCT04969796|Other|REACH Hope|REACH VA (Resources for Enhancing All Caregivers Health in Department of Veterans Affairs) and the DoD's Virtual Hope Box. For REACH Hope, as the caregiver and interventionist work on strategies one-on-one, these will be integrated into the Hope Box for the caregiver to use between and after sessions.
15736836|NCT04969783|Other|Ventilated Cigarette Filter|Ventilated Cigarette Filter
15736837|NCT04969783|Other|Unventilated Cigarette Filter|Unventilated Cigarette Filter
15736838|NCT04969770|Other|Ultrasound elastography (USE)|"Visualization of the vertebral disc and the para-vertebral muscles.
~Intra and inter observer reproducibility analysis carried out for each of the measurements made, by two operators.
~Patients with instrumented neuromuscular scoliosis: 5 elastographies : preoperatively, then during the usual follow-up consultations with the surgeon every 6 months for 2 years.
~Patients with neuromuscular pathologies without instrumented scoliosis: 4 elastographies during the usual follow-up consultations with the surgeon every 6 months for 2 years.
~Healthy control patients without neuromuscular pathology or scoliosis :
~1 elastography during an usual consultation."
15736839|NCT04969757|Device|Predigraft group|"Patients in the interventional arm will use Predigraft (Class 1 medical device under MDD 93/42/EEC Cibiltech Society) to receive therapeutic education content (videos, facts sheets, short messages, questionnaires), exchange documents with their doctors and interact via messaging with them.
~Physicians will be able to calculate their iBox score to predict their patients' allograft survival at 3, 5 and 7 years."
15736840|NCT04969744|Device|ICE|Intermittent Cooling Exposure using cooling garment for 1-2 hours
15736841|NCT04969731|Drug|Immuncell-LC|IV
15736842|NCT04969731|Drug|Gemcitabine|IV
15736843|NCT04969718|Other|LEADS Plus educational posters|This intervention covers depression and its symptoms, the link between depression and suicide, the risk and protective factors associated with suicide, the warning signs of suicide, seeking help and overcoming barriers to seeking help, and school and community suicide prevention resources. Six educational posters will also be displayed in class rooms
15736844|NCT04969718|Other|Question, Persuade, and Refer Plus educational posters|It is a manualised programme for gatekeepers, originally developed in the USA which to train teachers/school staff to identify the suicide risk in students and encourage students at risk of suicide to seek professional help. Six educational posters will also be displayed in classrooms.
15736845|NCT04969718|Other|Screening by Professionals programme plus educational posters|This is an indicated or selective intervention which is based on students' responses to the baseline questionnaires. Participating health professionals review students' responses to the questionnaires used in the study and students whose scores meet pre-established cutoff points will be invited to participate in a professional mental health clinical assessment and if needed, referred to clinical services. Six educational posters will also be displayed in classrooms.
15736846|NCT04969718|Other|educational posters|Six educational posters will be displayed in all schools in this cluster.
15736847|NCT04969705|Drug|Dexmedetomidine|"60 Patients will be randomly divided into three equal groups:
~Group A (n=20) : spinal anesthesia with Dexmedetomidine (5µg ) added to local anesthetic (bupivacaine Hcl ) (10 mg) given intrathecally .
~Group B (n=20) : spinal anesthesia using local anesthetic( bupivacaine Hcl) (20 mg) combined with TAP block using Dexmedetomidine (20µg ) after the cesarean section
~Group C (n=20) (controlled group ) : Spinal anesthesia using only local anesthetic (bupivacaine Hcl ) (10 mg) ."
15736848|NCT04969692|Procedure|warming to increase local skin (puncture site) temperature|According to the group of participants, investigator applies the warmer to the hands and wrists of the participants, makes a local temperature of 40℃ gradually, and maintains it for about 10 minutes in warming group (which is divided in to warming-palpation (WP) and warming-US (WU) group).
15736849|NCT04969679|Drug|E. coli Nissle 1917 (Mutaflor®)|Take 1 capsule per day in the morning from the first day to the fourth day and take 2 capsules per day from the fifth day to the end of the testing period.(for 8 weeks)
15736850|NCT04969679|Drug|Placebo|Take 1 capsule per day in the morning from the first day to the fourth day and take 2 capsules per day from the fifth day to the end of the testing period.(for 8 weeks)
15736851|NCT04969666|Drug|IPED2015|Active treatment
15736852|NCT04969666|Drug|Placebo|Placebo
15736853|NCT04969653|Other|Exposure of venous thromboembolism|Composite of pulmonary embolism and deep vein thrombosis
15736854|NCT04969640|Other|Optical coherence tomography|Anterior segment optical coherence tomography examination of corneas with infective keratitis
15736855|NCT04969627|Drug|Metformin|Use Metformin for 3 months to treat PCOS
15736856|NCT04969627|Drug|Exenatide|Use Exenatide for 3 months to treat PCOS
15736857|NCT04969601|Biological|vaccine COMIRNATY® (BNT162b2)|two injections of COMIRNATY® (BNT162b2) vaccine 21-28 days apart, of either 10, 20, 30 µg of vaccine, depending on the observed responses of previous children
15736858|NCT04969588|Diagnostic Test|Microsoft Azure Kinect Developer Kit|3D images and 3D joint coordinates are obtained.
15736859|NCT04969588|Diagnostic Test|Bioelectrical impedance analyzer|Fat mass, fat-free mass and percentage body fat in total body and body segments are estimated.
15736860|NCT04969588|Diagnostic Test|Dual Energy X-ray Absorptiometry|Skeletal length and body composition are estimated.
15736861|NCT04969575|Other|Insemination and culture|All MII oocytes will be inseminated by ICSI 39-41 hours post final oocyte maturation trigger.
15736862|NCT04969575|Other|Media refreshment Group 1|Zygote scoring on day 1 (18-20hpi). Culture medium refreshment will be done 67-69 hours post insemination (Day3).
15736863|NCT04969575|Other|Culture media preparation and refreshment|"30µL of culture medium (Global total LP is added to each well of the 8 wells of LifeGlobal GPS Dish (EGPS-010) and 50µL to the center 3 drops.
~Dishes will be equilibrated overnight in a CO2 incubator."
15736864|NCT04969575|Other|Embryo grading|Should be done prior to media refreshment. For group 2, embryo grading and media refreshment is done prior to blastocyst biopsy.
15736865|NCT04969575|Other|Media refreshment Group 2|Zygote scoring on day 1 (18-20hpi). Culture media refreshment will be done 114-118 hours post insemination (Day5).
15752701|NCT04837118|Other|Questionnaire Administration|Ancillary studies
15736866|NCT04969562|Behavioral|Emotional Freedom Technique|Emotional Freedom Technique (EFT, Emotional Freedom Technique) is a psychophysiological interpretation that combines elements of cognitive behavioral therapy (CBT), exposure therapy, and somatic stimulation using acupuncture points.
15736867|NCT04969549|Other|Theta burst stimulation|It consists of 20 sessions of iTBS over the dlPFC.
15736868|NCT04969536|Dietary Supplement|Branched Chain Amino Acids|Supplementation with 8 g Nutrex Research Amino Acid Drive BCAA in 8 ounces of water once each immediately pre-exercise and after 30 minutes of exercise
15736869|NCT04969536|Other|Placebo|Supplementation with 2.0 milliliters of a sucralose-based drink mix with 8 ounces of water once each immediately pre-exercise and after 30 minutes of exercise
15736870|NCT04969523|Procedure|lobectomy|Intravenous es-ketamine 0.5mg/kg or saline during lobectomy
15736871|NCT04969510|Drug|10 mg PRAX-114|Once daily oral treatment
15736872|NCT04969510|Drug|20 mg PRAX-114|Once daily oral treatment
15736873|NCT04969510|Drug|40 mg PRAX-114|Once daily oral treatment
15736874|NCT04969510|Drug|60 mg PRAX-114|Once daily oral treatment
15736875|NCT04969510|Drug|Placebo|Once daily oral treatment
15736876|NCT04969497|Drug|"Treatment A: M207 3.8 mg MiniMac"|"Treatment A: M207 3.8 mg administered as two 1.9 mg patches 30 minutes wear time (upper arm application) - made on a MiniMac coater and packaged in foil cups"
15736877|NCT04969497|Drug|"Treatment B: M207 3.8 mg MACAP"|"Treatment B: M207 3.8 mg administered as two 1.9 mg patches 30 minutes wear time (upper arm application) - made on a MACAP coater and packaged in foil cups"
15736878|NCT04969497|Drug|Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0|Treatment C: 5.0 mg Intranasal Zolmitriptan administered at time = 0 and 2 hours post time 0
15736879|NCT04969484|Other|Telehealth visit|ImPACTT Telehealth visit with the PC provider
15736880|NCT04969471|Device|enVast stent|In addition to conventional treatment, the treating physician will deploy as the first measure to obtain reperfusion, a enVast stent at the occlusion site in order to withdraw the clot.
15736881|NCT04969471|Procedure|conventional treatment|Treatment strategies may include balloon angioplasty, manual aspiration thrombectomy and/or coronary stenting.
15736882|NCT04969458|Other|survey application|"Data collection tools used in the study;
~Clinic and Demographic Evaluation Form
~Oswestry Low Back Pain Disability Index (ODI)
~Patterns of Activity Measure Pain (POAM-P)
~Roland-Morris Disability Questionnaire (RMDQ)
~Hospital Anxiety and Depression Scale (HADS)
~Graded Chronic Pain Scale Version 2.0 (GCPS 2.0)"
15736883|NCT04969445|Biological|Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)|The bivalent HPV-16/18 vaccine was a mixture of two aluminum hydroxide adjuvant-absorbed recombinant L1 VLPs of HPV-16 and HPV-18 expressed in E. coli. A 0.5 ml dose of the bivalent HPV test vaccine comprised 40 μg of HPV-16 and 20 μg of HPV-18 L1 VLPs absorbed with 208 μg of aluminum adjuvant
15736884|NCT04969432|Other|Client-centered|Rehabilitation
15736885|NCT04969419|Other|Exposure of skin cancer of interest|Melanoma and nonmelanoma skin cancers: squamous cell carcinoma, basal cell carcinoma and actinic keratoses.
15736886|NCT04969406|Other|Brillouin Spectroscopy via BOSS System|Biomechanical Imaging of the Cornea and Lens
15736887|NCT04969393|Device|High intensity laser therapy|"Fifteen treatment sessions with pulsed Nd: YAG laser were applied to the subjects of the study group, three sessions per week, over 5 weeks in succession via EXAND MY 1064 nm Laser system, Mectronic Medicale, Italy. Patients in group (A) received HILT along with the conventional physical therapy program. The session involved 3 subphases: (1) The Initial phase Analgesic phase, (2) In the intermediate phase Trigger point phaseand (3)The final phase Bio-stimulation phase was applied for 6 minutes with a slow scanning in several parallel longitudinal lines."
15736888|NCT04969393|Other|Conventional Physical Therapy|Fifteen treatment sessions that involved using a neutral custom volar splint alongside neural and tendon gliding exercises. the splint was used at night and while performing strenuous activities during the day for 5 weeks. While nerve and tendon gliding exercises was repeated 10 times at each session and patients were encouraged to apply exercise 3-5 times per day for 5 weeks.
15736889|NCT04969380|Device|Sofwave|The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues.
15736890|NCT04969367|Other|Medical Device Usage and Evaluation|Wear activity monitor (Fitbit)
15736891|NCT04969367|Procedure|Biospecimen Collection|Undergo collection of blood samples
15736892|NCT04969367|Other|Questionnaire Administration|Complete questionnaires
15736893|NCT04969367|Other|Quality-of-Life Assessment|Complete questionnaires
15736894|NCT04969354|Biological|CAR-T cell immunotherapy|This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at CAIX antigen.
15736895|NCT04969341|Other|Survey Administration|Complete survey
15736896|NCT04969341|Other|Electronic Health Record Review|Review of medical records
15736897|NCT04969328|Other|ParTNer-STEPs|"The intervention is a transfer program (ParTNer-STEPs), offered to the parents 1½ - ½ year before their child´s transfer to adult care.
~ParTNer-STEPs consist of
~an informative website available for parents from recruitment until follow-up.
~online educational events for parents. The teaching events are offered twice a year as a web based seminar with short presentations on different topics. The seminars will not be available for parents after their child has transferred to adult care.
~transfer consultations across the paediatric and adult department. The transition consultations consist of:
~a preparatory consultation (3-6 months before transfer) with the paediatric nurse.
~a farewell consultation with the paediatric nurse (0-3 months before transfer).
~a joint consultation (at transfer) where both the pediatrician and the adult physician will be present.
~a welcoming consultation with the nurse from the adult care (0-3 months after transfer)."
15736898|NCT04969315|Drug|TT-10|TT-10 orally administered BID starting at 10 mg and will be increased to 200 mg (additional dose levels maybe explored, if appropriate based on emerging safety, PK or PD data).
15736929|NCT04969029|Drug|Tirelizumab|In the immunotherapy group, the treatment regimen was Tirelizumab 200mg, intravenously infused once every 3 weeks until the end of 12 months of treatment, with a total of 17 infused times.
15736930|NCT04969016|Procedure|LSA (liquid skin adhesive)|surgical wound closure with liquid skin adhesive (LiquiBand®)
15736931|NCT04969016|Procedure|stapler|surgical wound closure with stapler
15753489|NCT04830449|Drug|HCP1904-2|Take it once daily for 8 weeks orally.
15736900|NCT04969289|Behavioral|Dr. Eric Digital Health Intervention|Dr. Eric is a user-informed, theory-based, digital health intervention that aims to improve adolescent male SRH. This ED-based intervention consists of two parts-an interactive, tailored app and 3 months of personalized, two-way text messaging. It is based on an evidence-based sexual health curriculum we developed using established behavioral theories, prior literature, input from key stakeholders, qualitative patient interviews, and our prior ED-based work.
15736901|NCT04969276|Biological|Quadrivalent Inactivated Influenza High Dose|Sterile suspension for injection in a pre-filled syringe Intramuscular injection
15736902|NCT04969276|Biological|COVID-19 mRNA Vaccine (nucleoside modified)|Sterile suspension (white to off-white) in multidose vial Intramuscular injection
15736903|NCT04969263|Biological|mRNA-1273 vaccine (Pfizer/BioNTech)|30 microgram dose
15736904|NCT04969263|Biological|mRNA-1273 vaccine (Moderna)|100 microgram dose
15736907|NCT04969237|Diagnostic Test|Vitamine D in blood samples|vitamine D values
15736910|NCT04969211|Drug|VHX-896 and iloperidone|oral tablet
15736911|NCT04969211|Drug|Iloperidone and VHX-896|oral tablet
15736913|NCT04969172|Drug|Exosomes overexpressing CD24|The suggested therapeutic agent here is based on an existing therapeutic platform that uses exosomes that were engineered to overexpress CD24 that can directly suppress the cytokine storm. The exosomes will be isolated and purified from human embryonic kidney T-REx™-293 cells that constitutively express high levels of human CD24.
15736914|NCT04969159|Other|no intervention|standard treatment in the clinical routine
15736915|NCT04969146|Behavioral|Dyadic Intervention|The patient and caregiver dyads will complete and return baseline questionnaires and then be randomized to Modified CBTi Dyadic Intervention. The patient and caregiver in the dyadic intervention will have 5 sessions of Modified CBTi. Upon completion of the intervention, the patient and caregiver will complete the follow up assessments at approximately 3 months and 6 months after the baseline questionnaires.
15736916|NCT04969146|Behavioral|Patient Only Intervention|The patient and caregiver dyads will complete and return baseline questionnaires and then be randomized to Modified CBTi Patient Only Intervention. The patient in the Patient Only Intervention will have 5 sessions of Modified CBTi. Upon completion of the intervention, the patient and caregiver will complete the follow up assessments at approximately 3 months and 6 months after the baseline questionnaires.
15736917|NCT04969133|Drug|Levobupivacaine Hydrochloride 2.5 MG/ML|To compare TAP block versus local infiltration of the trocar wounds with levobupivacaine 2.5 mg/ml for post operative pain relief after laparoscopic appendicectomy in children
15736918|NCT04969120|Drug|Metoclopramide 10mg|this group receive 10mg intravenous metoclopramide slowly over 2 minutes the medication will be repeated every 2 hours for a maximum three doses
15736919|NCT04969120|Drug|Placebo (0.9 sodium chloride)|this group receive 10mg intravenous placebo(0.9 sodium chloride) slowly over 2 minutes the medication will be repeated every 2 hours for a maximum three doses
15736920|NCT04969107|Procedure|taTME|Resection of rectal cancer with preparation of the mesorectal plane along the TME-plane in a rendezvous procedure of an abdominal and a transanal approach.
15736921|NCT04969107|Procedure|abdTME|Resection of rectal cancer with preparation of the mesorectal plane along the TME-plane in an abdominal Approach.
15736922|NCT04969094|Other|Neuromuscular electrical stimulation (NMES)|Participants will receive NMES to the hip abductors while performing strength training 3 times per week for 3-months
15736923|NCT04969094|Other|Multi-Modality Balance Intervention (MMBI)|Participants will attend a group balance class that focuses on movement and obstacle negotiation 3 times per week for 3-months
15736924|NCT04969081|Behavioral|referral to work focused program|referral to Incentive Therapy or to Other Therapeutic and Supported Employment Services
15736925|NCT04969081|Other|treatment as usual|usual treatment
15736926|NCT04969068|Drug|Remimazolam|Interventions:The dose of remimazolam for each patient was determined by the response of the previously tested patients using the modified Dixon's up-and-down method.The first patient was tested at 0.2mg/kg remimazolam (0.025mg/kg as a step size). Duodenoscopy insertion was conducted when MOAA/S≤1.The response of the patients to the duodenoscopy insertion during ERCP was categorized as either 'success (no movement)' or 'failure (movement).' Movement was defined as difficult duodenoscopy insertion ,gross purposeful muscular movement, coughing, vomiting, or laryngospasm occurring during or after insertion of duodenoscopy .No movement was depicted when the reactions mentioned earlier were absent.
15736927|NCT04969055|Other|Not|Not
15736928|NCT04969042|Device|Pins Medical G122 RS|G122RS model implanted spinal cord stimulation device, which could give closed-loop functional stimulation in the epidural space
15736963|NCT04968782|Other|Patients with acute appendicitis|No intervention, single survey
15736964|NCT04968769|Other|ischemic compression|manual therapy
15736932|NCT04969003|Behavioral|Short videos|Intervention videos will each be of 90-second duration and feature four underage professionals (ages 16) acting as simulated patients. All videos will focus on an empowered presenter with depression sharing their personal story regarding depression and describe how social supports from family, friends, and community, as well as professional help assisted them in overcoming symptoms of their illness. The actors will include a transgender male, a cis-gender male, a transgender female, and a cis-gender female.
15736933|NCT04968990|Device|Proton Beam Radiation (PBRT)|The treatment approach with radiation therapy prescribed in this trial is designed to deliver highly conformal radiation therapy (proton beam radiation or intensity modulated photon radiation) to target volumes that are based on the burden of disease.
15736934|NCT04968990|Drug|DD-4A Chemotherapy Regimen|Patients will receive standard of care chemotherapy based on diagnosis and stage.
15736935|NCT04968990|Procedure|Complete Surgical Resection|Participants will undergo complete surgical resection at diagnosis or after 6-12 weeks of induction chemotherapy
15736936|NCT04968990|Procedure|Surgical Resection|Participants will undergo surgical resection at diagnosis or after 6-12 weeks of induction chemotherapy.
15736937|NCT04968990|Procedure|Partial Nephrectomy|Participants will undergo partial nephrectomy after 6-12 weeks of induction chemotherapy.
15736938|NCT04968977|Procedure|PCI vs. CABG|PCI vs. CABG
15736941|NCT04968951|Drug|Metronidazole|Antibiotic treatment - 250 mg every 6 hrs for 5 days
15736942|NCT04968951|Drug|Placebo|Placebo treatment
15736943|NCT04968951|Drug|Vancomycin|Antibiotic treatment - 125 mg every 6 hrs for 5 days
15736944|NCT04968951|Biological|Fecal Microbiota Transplantation|Encapsulated biologically active human fecal material (donor stool) is provided in capsule form. The fecal material is homogenized with sterile saline, then pelleted and re-suspended in sterile saline/40% glycerol. Participants will receive 15 FMT capsules per day for 3 consecutive days. Capsule are to be swallowed under direct supervision.
15736945|NCT04968938|Drug|3,4-methylenedioxymethamphetamine|Behavioral: Therapy
15736946|NCT04968925|Device|ACUVUE Oasys 1-Day|TEST
15736947|NCT04968925|Device|Precision 1|CONTROL
15736951|NCT04968899|Drug|Neofordex®|Oral dexamethasone (Neofordex®) 40 mg (Day1 to Day 4), ± an additional 4-days cycle of dexamethasone between days 10 and 21.
15736952|NCT04968899|Drug|Intravenous immunoglobulins|IVIg (1g/kg D1-D2) plus oral prednisone (1 mg/kg/day x 21 days (3 weeks))
15736953|NCT04968886|Diagnostic Test|Diagnostic Test: viability test on sputum and comparision with culture results (reference test)|Diagnostic Test: viability test on sputum and comparision with culture results (reference test)
15736954|NCT04968873|Procedure|Cholecystectomy and common bile duct exploration|During elective open cholecystectomy, a basal commcn dile duct (CBD) manometry was obtained immediately after cholecystectomy, with a 10 Fr. silicone T tube introduced into the cystic duct and connected to a glass manometer.
15736955|NCT04968860|Other|This study is observational|"Clinical evaluation of the oral health condition
~Microbiota evaluation by analyzing the collected saliva
~Application of questionnaires of quality of life"
15736956|NCT04968847|Device|FemaSeed Localized Directional Insemination|Subjects undergoing FemaSeed Artificial Insemination
15736957|NCT04968834|Genetic|Genomic profiling|Genomic profiling using CLIA assay
15736958|NCT04968821|Behavioral|Physical activity intervention|Participants randomized to the physical activity intervention will receive a Fitbit and be enrolled in Fitabase (Fitbit tracking system). Participants will also participate in 8 tele-health sessions with a physical therapist. Sessions will involve setting weekly physical activity goals and reviewing the participant's physical activity on the Fitbit tracking system.
15736959|NCT04968821|Other|Usual care|Usual postoperative care includes surgeon-directed lifting restrictions, advice to stay active, and oral analgesics as needed. Physical therapy referral will be at the discretion of the surgeon. However, physical therapy is not typically started until 12 weeks after surgery.
15736960|NCT04968808|Procedure|Staged in-hospital complete revascularization|Patients with non-ST-segment elevation myocardial infarction and multivessel disease will be randomized after percutaneous coronary intervention (PCI) for infarct-related artery (IRA). All patients will be randomized to immediate complete revascularization group or staged revascularization group by 1:1 fashion. Staged in-hospital complete revascularization group will receive staged PCI for non-IRA in other day (during hospitalization) after PCI for IRA. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without fractional flow reserve (FFR) evaluation. Non-IRA lesion with diameter stenosis 50-69% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.
15736961|NCT04968808|Procedure|Immediate complete revascularization|Patients with non-ST-segment elevation myocardial infarction and multivessel disease will be randomized after percutaneous coronary intervention (PCI) for infarct-related artery (IRA). All patients will be randomized to immediate complete revascularization group or staged revascularization group by 1:1 fashion. Immediate complete revascularization group will receive simultaneous PCI for both IRA and non-IRA during index PCI. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without fractional flow reserve (FFR) evaluation. Non-IRA lesion with diameter stenosis 50-69% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.
15736962|NCT04968795|Other|Heartfulness Meditation|A four-week Heartfulness Wellness seminar, where people are exposed to Heartfulness Meditation and its meditation tools. Participants experience: Heartfulness Guided Relaxation, Heartfulness Meditation and Heartfulness Unwinding/Rejuvenation Technique.
15736967|NCT04968756|Device|Selective retina therapy SPECTRALIS CENTAURUS device|Microsecond laser microsurgery by using the SPECTRALIS CENTAURUS device
15736968|NCT04968743|Device|Transcranial magnetic stimulation (TMS)|TMS will be administrated with a Magstim 70mm figure-8 coil allowing for focal stimulation. Single-pulse TMS will be applied at different phases, (0, 90, 180, 270 degrees - 4 stimulation conditions), of the ongoing mu-rhythm. Positioning of the TMS coil will be neuronavigated based on individual MRI scans. Stimulation will be applied in a closed-loop fashion while the participant is at rest and their EEG activity is recorded.
15736969|NCT04968730|Other|Postoperative rehabilitation nursing|Make postoperative rehabilitation plan according to nursing experience for group A Develop rehabilitation process according to the activity plan for group B
15736970|NCT04968704|Other|3D photography and computer modelling|3D photography is available at our unit department of clinical photography. Photos will be taken and the associated NHS software (Canfield Imaging scientific, inc) used to sit down with the patients and model their reconstruction, thereby reducing anxiety and improving awareness of their treatment plan.
15736971|NCT04968691|Other|Telerehabilitation based exercise treatment|The telerehabilitation group will be shown how to do the exercises online by the researcher before each session, 3 sessions a week for 6 weeks, with mobile telecommunication applications, and it will be ensured that the patients do the exercises correctly and are followed up. In addition, at the beginning of each week, videos with the exercise content of that week will also be sent.
15736972|NCT04968691|Other|Home based exercise treatment|n the study, exercise cards were given to the control group and the exercise treatment they were asked to do at home 3 sessions a week for 6 weeks
15736973|NCT04968678|Diagnostic Test|P-wave duration measurement on 12 lead ECG with standard parameters|Hospital records will be used in order to obtain baseline characteristics and the most recent 12-lead ECG in sinus rhythm prior to ablation will be used to calculate PWD. Measurement of the PWD will be obtained at standard surface ECG recording settings of 25mm/s and 10mm/mV and measured accordingly to our previous protocol. In brief, all ECGs obtained will subsequently be anonymised and randomised by an Independent Clinical Investigator (ICI) before measured by the main clinical investigators blinded to initial results. If a dispute of the measurements arouse, consensus will be used to resolve it after consulting the Chief Investigator (CI) blinded to the results. Bland-Altman plots to minimise bias will be used
15736974|NCT04968665|Diagnostic Test|gait testing, functional MRI|diagnostic tests including the gait testing and functional MRI
15736975|NCT04968626|Radiation|PI-LL|The pelvic parameters were collected including PI, pelvic tilt (PT), sacral slope (SS) and LL ,and compared between IS patients and the AS group. Besides, spinopelvic malalignment was defined as an absolute value of PI-LL greater than 10.In the IS group,the clinical symptoms were assessed with the Japanese Orthopaedic Association (JOA) score and the visual analogue scale (VAS). We compared spinopelvic parameters between the asymptomatic adults and the IS patients. Additionally, we investigated correlations between spinopelvic parameters and clinical symptoms.
15736976|NCT04968613|Drug|Madopar monotherapy|In addition to basic treatment, the patient also received Madopar treatment
15736977|NCT04968613|Drug|senfrol monotherapy|In addition to the basic treatment, the patient also received the rofosson treatment
15736978|NCT04968613|Drug|placebo monotherapy|In addition to basic treatment, the patient also received selegiline treatment
15736979|NCT04968600|Procedure|total knee arthroplasty|Posterior-cruciate-ligament is retained in one arm and sacrificed in another arm during total knee arthroplasty
15736980|NCT04968587|Procedure|Sustained Low-Efficiency Dialysis|All patient requiring Renal replacement Therapy in the intensive care unit will be randomized in open order (cross-over) with either Regional Antigoagulation with Citrate or Regional Anticoagulation by Decalcification without Citrate
15736981|NCT04968574|Drug|taladegib|hedgehog pathway inhibitor dosed once daily
15736982|NCT04968574|Drug|placebo|identical tablets to the experimental arm with no active ingredient
15736983|NCT04968548|Procedure|Blood collection|Peripheral blood will be collected via routine venipuncture procedure
15736984|NCT04968535|Device|StimaWELL|mid frequent electrotherapy mat covering the whole spinal cord with different stimulation protocols installed
15736985|NCT04968522|Drug|Methylphenidate Hydrochloride|This study is a N-of-1 RCT of currently prescribed stimulant medications for treatment of ADHD symptoms in children with FASD, relative to matched placebo capsules. The Ritalin 10 will be administered at the child's prescribed dose and may include a half tablet (5mg) increment. Ritalin 10 will be encapsulated in full tablet (10mg) or half tablet (5mg) dose.
15736986|NCT04968522|Drug|Placebo|The placebo is Maize Starch and Pregelatinised Maize Starch. The placebo will be encapsulated using the same capsule that is opaque so that participants cannot distinguish the two visually. Where the active mediation amount is small for the capsule, there will be additional Starcke 1500 (Maize Starch and Pregelatinised Maize Starch) added to fill the capsule so that the active drug and capsule also weigh approximately the same. The dose of placebo will be matched to the participants currently prescribed stimulant medication.
15736987|NCT04968522|Drug|Methylphenidate hydrochloride|This study is a N-of-1 RCT of currently prescribed stimulant medications for treatment of ADHD symptoms in children with FASD, relative to matched placebo capsules. The Ritalin LA will be administered at the child's prescribed total dose. Ritalin LA will be encapsulated.
15736988|NCT04968522|Drug|Methylphenidate Hydrochloride 18 MG|This study is a N-of-1 RCT of currently prescribed stimulant medications for treatment of ADHD symptoms in children with FASD, relative to matched placebo capsules. The Concerta (18mg) will be administered at the child's prescribed total dose. Concerta will be encapsulated.
15736989|NCT04968522|Drug|Dexamphetamine sulfate|This study is a N-of-1 RCT of currently prescribed stimulant medications for treatment of ADHD symptoms in children with FASD, relative to matched placebo capsules. The Dexamphetamine (10mg) will be administered at the child's prescribed total dose. Dexamphetamine will be encapsulated.
15736990|NCT04968509|Drug|PCSK9 inhibitor and Statin|Patients in experimental group were treated with PCSK9 inhibitors (140mg with Evolocumab or 75mg with Alirocumab subcutaneously every two weeks) and conventional intensive lipid-lowering therapy(Atorvastatin 40-80mg or Rosuvastatin 20-40mg or Atorvastatin 20mg+ Ezetimibe 10mg or Rosuvastatin 10mg+ Ezetimibe 10mg).
15736991|NCT04968509|Drug|Statin|Patients in control group were only treated with conventional intensive lipid-lowering therapy(Atorvastatin 40-80mg or Rosuvastatin 20-40mg or Atorvastatin 20mg+ Ezetimibe 10mg or Rosuvastatin 10mg+ Ezetimibe 10mg).
15736992|NCT04968496|Other|Food Secure Group|Weekly meals (five breakfast and five lunch meals) will be provided to all children randomized to this group to prevent the onset of summertime food insecurity
15736993|NCT04968483|Other|Data collection|The general data, data of postoperative complications, data of nutritional assessment and nutritional support will be collected.
15736994|NCT04968444|Other|Physiotherapy|"Physiotherapy helps to restore movement and function when someone is affected by injury, illness or disability. It can also help to reduce your risk of injury or illness in the future.
~This can take the form of
~advice and education
~manual therapy
~exercise prescription
~relaxation"
15736995|NCT04968444|Other|Back Pain Workshop|Back workshop is an intervention protocol consisting of an educational program and skills acquisition program, including physical exercises. The session is supervised by a specialist physiotherapist.
15736996|NCT04968431|Other|2D Echocardiography|Mitral valve area will be determined by 2 D echo-Doppler methods
15736997|NCT04968431|Other|3D Echocardiography|Patients included in the study will undergo 3D Echo after being evaluated with 2D Echo. Mitral valve area will be determined by real time 3D.
15736998|NCT04968418|Device|APDM OPAL system wearable IMU|The OPAL system contains wearable IMUs with a sampling rate of 128 Hz and a resolution of 17.5 bits. Each IMU has a size of about 44mm 40mm 14mm × × and weighs less than 25 gm.
15736999|NCT04968405|Device|Catalyst CSR Total Shoulder System|The Catalyst CSR Shoulder System is a bone preserving total shoulder prosthesis designed for use in patients where the humeral head, neck and glenoid vault are of sufficient bone stock and there is an intact or reconstructable rotator cuff. The design requires minimal bone resection, thus giving the patient an alternative to other total shoulder designs where more bone is removed.
15737000|NCT04968392|Drug|Dexmedetomidine Hydrochloride|20 mL of 0.25% levobupivacaine plus 0.5 µg/kg dexmedetomidine
15737001|NCT04968392|Drug|Levobupivacaine|20 mL of 0.25% levobupivacaine plus 1 mL normal saline
15737002|NCT04968379|Drug|Ferric carboxymaltose|Intravenous
15737003|NCT04968366|Biological|Autologous dendritic cells pulsed with multiple neoantigen peptides.|Each dosage of Dendritic Cells (DC) vaccine contains 2-10 million DC cells, loaded with 5-20 tumor neoantigen peptides. DC vaccine will be administered (i.d) around lymph nodes of the groin and Axillary at 2nd, 3rd, 4th, 7th and 11th week after the completion of concurrent Temozolomide chemoradiation. After 5 injections, the investigator will review subject's tolerance and compliance; and, decide whether to administer more DC vaccines up to 8 injections. For certain patients with good tolerance and clinical response of the DC vaccine, peripheral blood is extracted after completion of Temozolomide adjuvant chemotherapy to assess the patient's immune response. According to the result, investigators will decide whether to perform 1-2 more treatment cycles (5-8 injections/cycle) to strengthen the effectiveness
15737004|NCT04968366|Drug|Temozolomide adjuvant chemotherapy|Temozolomide is administered as the standard-of-care adjuvant chemotherapy, in combination with the DC vaccines to treat the enrolled patients.
15737005|NCT04968353|Device|Incisally-beveled attachment|Incisally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
15737006|NCT04968353|Device|Gingivally-beveled attachment|Gingivally-beveled attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
15737007|NCT04968353|Device|Optimized attachment|Optimized attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
15737008|NCT04968353|Device|Horizontal attachment|Horizontal attachments will be bonded to teeth before or during orthodontal treatment with clear aligners
15737009|NCT04968340|Procedure|conventional cs|opening the lower uterine segment with introduction of the surgeon hand below the fetal head during its extraction
15737010|NCT04968340|Procedure|external pop out teqnique|support of lower uterine segment without introduction of the surgeon hand below the fetal head during its extraction
15737011|NCT04968327|Other|Micro-osteoperforations (MOPs)|MOPs included shallow perforations of the buccal cortical plate surrounding the tooth that requires orthodontic tooth movement, with no flap reflection was performed using a surgical bur using the special calibrated device called PROPEL
15737012|NCT04968327|Other|Conventional canine retraction|using nickel-titanium (NiTi) closed coil-springs delivering a force of 150 grams per side
15737013|NCT04968314|Behavioral|Chicago Parent Program|Chicago Parent Program (ChiPP) is a 12-session group-based parenting skills program
15737014|NCT04968301|Device|ultrasound Doppler|A cross-sectional study:the development of the hip joint was studied by measuring the anatomical circumference of the capsular muscle of the iliac joint with ultrasound Doppler
15737015|NCT04968275|Behavioral|CHAMPS|CHAMPS provides personalized feedback on participants' cannabis use behaviors and supports strategies to change such behaviors. It comprises six modules measuring the use of cannabis protective behavioural strategies, exploring the possible benefits of changing cannabis practices and setting and monitoring the reach of a SMART cannabis use goal.
15737016|NCT04968262|Other|Sepsis therapy|Patients receiving sepsis therapy followed the international guidelines of the 2016 Surviving Sepsis Campaign regarding fluid resuscitation, feeding, vasopressor, respiratory, anticoagulation and hydrocortisone therapy, along with ulcer prophylaxis and sedation. Blood and urine samples were collected at the intensive care unit from this patient group at three time points (T1-3): T1: within 24 hours after admission; T2: second day morning; T3: third day morning of follow-up. 24 patients were documented without sepsis and acute kidney injury as a control group.
15737017|NCT04968262|Other|Sepsis-related acute kidney injury therapy|Patient management of sepsis and sepsis-related acute kidney injury followed the international guidelines of the 2016 Surviving Sepsis Campaign regarding fluid resuscitation, feeding, vasopressor, respiratory, anticoagulation and hydrocortisone therapy, along with ulcer prophylaxis, sedation and renal replacement therapy (if needed). In this patient group, blood and urine sampling was performed at three time points (T1-3): T1: within 24 hours after admission; T2: second day morning; T3: third day morning of follow-up.
15737018|NCT04968249|Other|Observational|Observational Cohort to understand risk factors for early COPD.
15737022|NCT04968197|Device|Vestibular Intervention via Portable Electrical Stimulator (VIPES) system|A small, lightweight device able to deliver stochastic vestibular stimulation (SVS) using a comfortable electrode set on the back of the head as well as other proven modes of galvanic vestibular stimulation (GVS) related vestibular correction when required to mitigate motion sickness or provide auxiliary vestibular cueing.
15737023|NCT04968184|Drug|Placebo|Participants will orally receive placebo matching to KBP-5074 tablets QD.
15737024|NCT04968184|Drug|KBP-5074|Participants will orally receive KBP-5074 tablets, from 0.25 mg to a maximum dose of 0.5-mg QD.
15737025|NCT04968158|Drug|Etoricoxib 90 mg / Tramadol 50 mg|One packet diluted in 100 ml of water, every 24 hours of 90 mg/50 mg.
15737026|NCT04968158|Drug|Acetaminophen 325 mg / Tramadol 37.5 mg|One tablet, every 8 hours of 325 mg/ 37.5 m
15737027|NCT04968145|Other|Home To Stay Mobile Health Application|"Home to stay is an integrated discharge monitoring system with a mobile application. Features of the application include a Daily Health Check to report on post-operative recovery, picture taking capability to photograph incisions/wounds and educational information on post-operative care at home.
~Patients will complete a Daily Health Check on post-discharge Day #1-14, #21 and #30. The Daily Health Check consists of a series of questions specific to colorectal surgery as well as the Quality of Recovery (QoR-15) questionnaire. After completion, the participant will receive a list of recommendations tailored to their responses including relevant education modules, to contact the surgical team or in urgent cases to go to the nearest emergency room. The participants' responses will be monitored daily via a secure web site. Any participants' responses in the extreme ranges are automatically red flagged and notify the health care team that a follow up telephone call is required."
15737028|NCT04968132|Other|Multicomponent opioid reduction and pain management pathway|Pre-operative pain education and expectation setting, identification and modification of risk factors in high risk patients, postoperative individualized analgesic prescriptions, and continued support for pan control and recovery facilitated by an interventions coordinator.
15737029|NCT04968132|Other|Standard care|Standard perioperative care, surgical treatment, and pain medications.
15737030|NCT04968119|Other|Exercise Intervention|Participate in telehealth exercise sessions
15737031|NCT04968119|Other|Quality-of-Life Assessment|Ancillary studies
15737032|NCT04968119|Other|Questionnaire Administration|Ancillary studies
15737033|NCT04968106|Drug|Doxorubicin|Doxorubicin will administered by intravenous infusion on day 1 every 3 weeks (75 mg/m²) up to 4 cycles
15737034|NCT04968106|Drug|Ifosfamide|Ifosfamide will be administered by intravenous infusion over 3 days every 3 weeks (9 g/m²) up to 4 cycles
15737035|NCT04968106|Drug|INCMGA00012|Retifanlimab will be administered by intravenous infusion on day 1every 3 weeks (375 mg) up to 4 cycles
15737036|NCT04968093|Behavioral|Mindfulness-based therapy.|"Educational. Patients are given recommendations on the approach to the use of drugs for acute treatment of migraine headache and on lifestyle issues. Patients will be encouraged to restrict use of acute medications to headaches and to engage in regular physical activity, avoiding skipping meals, remain well hydrated, maintain a regular sleep.
~Mindfulness therapy. The intervention is delivered in small groups and consisted of 7 weekly group sessions. It was aimed to teach and make direct practice with skills intended to enhance sustained, non-judgmental present moment awareness. Each session was conducted by a neurologist and a psychologist. To patients were asked to close their eyes and focus their attention on the breathing so that they can concentrate on the present moment and on all the sensations. Intervention's main topics: posture education; breath use and control; guided body scan; work with sounds; tension release; guided imagery; decentralization of thoughts."
15737037|NCT04968080|Device|Infrared Cameras Inc. (ICI) FMX 400 Infrared (IR) Camera System|Infrared thermal camera
15737038|NCT04968080|Device|Welch Allyn SureTemp Plus 690|Oral thermometer
15737039|NCT04968080|Device|Welch Allyn ThermoScan PRO 6000|Ear thermometer
15737040|NCT04968080|Device|Infrared Cameras Inc. (ICI) HotSpot Infrared (IR) NonContact Infrared Thermometer|Forehead temperature gun
15737041|NCT04968067|Device|App group|In addition to the usual care, the participant will receive a health talk related to CHD care, a CHD app and a briefing from a trained research nurse (A). The app provides features such as structured e-educational contents and supportive features such as knowledge platform and member area.
15737042|NCT04968067|Device|Nursing telephone advice (NTA) group|All subjects will continue their usual care with prescribed medical treatments and follow-ups if any. By appointment, a trained nurse will provide a health talk related to the CHD care. In addition to the above usual care, three monthly 20-minute telephone follow-ups supplemented by take home leaflet will be provided by a trained research nurse for up to 3 months. Patients can ask about their related health problems, if any. The team has set up a telephone advice guide to support the research nurse in giving phone advice and text messages. .In summary, all two groups will receive from a nurse similar educational content as that related to their CHD and care. The only difference will be the re-enforcement and continual support provided through an app, telephone nursing advice and leaflet.
15737043|NCT04968054|Drug|Arm I (Propofol)|Propofol group will be inducted and maintained total intravenous anesthesia with propofol 2% and remifentanil under Shinider and Minto target controlled infusion (TCI) model, respevtively.
15737044|NCT04968054|Drug|Arm II (Remimazolam)|Remimazolam group started total intravenous anesthesia with remiamazolam at 6 mg/kg/h at the time of anesthesia induction, and maintained at 0.5-1.5 mg/kg/h.
15737045|NCT04968041|Behavioral|Motivational Interviewing-Cognitive Behavioral Therapy Ketogenic Nutrition Adherence Program|The intervention using strategies from motivational interviewing and cognitive behavioral therapy to promote motivation and adherence to ketogenic nutrition in older adults at high risk for Alzheimer's disease. The program is a 6-week, group program led by a psychologist and nutrition expert.
15737071|NCT04967820|Other|resilience and institutional support|psychological inherent resilience and institutional support during COVID-19 outbreak
15737072|NCT04967807|Diagnostic Test|Cardiac PET/MRI|An imaging technique that combines the strengths of both MRI and PET into one comprehensive study. This technique allows for detailed myocardial tissue characterization with MRI (including assessment of myocardial edema and fibrosis) and metabolic changes (including myocardial inflammation).
15737046|NCT04968028|Procedure|ACAF|(1)A standard right-side Smith-Robinson approach is performed. (2) The involved disc tissues are removed. The posterior longitudinal ligament is cut down at the levels cephalic and caudal to OPLL. (3) The anterior portion of the middle vertebral bodies is removed according to the thickness of ossification. Suitable cages are placed into each intervertebral space. (4) On the left side of the vertebra, a 2-mm-wide groove is created at the medial border of the transverse foramina. After that, an curved plated is fixed with screws. (5) On the right side of the vertebrae, a similar groove was also created. (6) Finally, tightening the screws to achieve a gradual evaluation of the vertebrae with OPLL.
15737047|NCT04968028|Procedure|Laminoplasty|(1) In the prone position, the skin and nuchal ligament were cut through the posterior median incision, and the paravertebral muscles were stripped layer by layer to expose the bilateral vertebral lamina, lateral mass and articular process.（2) Part of spinous process were removed with bone biting forceps. The side with more severe symptoms was selected as the open side, bone groove was performed at 2-3 mm of the medial edge of bilateral facet joints with the medial cortex was reserved at the shaft side.（3) Slowly lift the lamina and maintained.（4)Determining the opening width of each segment by trial, and selecting the appropriate size Arch miniplate, and fixed with screws.
15737048|NCT04968015|Drug|Cytarabine-Venetoclax Association|Consolidation treatment with cytarabine + venetoclax
15737049|NCT04968015|Drug|Cytarabine-Idarubicin Association|Consolidation treatment with cytarabine + idarubicin
15737050|NCT04968002|Drug|pablizumab combined with apatinib and neoadjuvant chemotherapy|The patients with stage IIa-IIIa non-small cell lung cancer are treated with pablizumab combined with apatinib and neoadjuvant chemotherapy
15737051|NCT04967989|Procedure|Low Energy SLT|SLT performed at low energy
15737052|NCT04967989|Procedure|Standard Energy SLT|SLT performed at standard energy
15737053|NCT04967976|Procedure|TiLoop Bra mesh in expander-implant breast reconstrution|The tissue expander is inserted with TiLoop Bra mesh in the first stage of reconstruction immediately after nipple/skin-sparing mastectomy. The tissue expander is placed sub-pectoral.
15737054|NCT04967976|Procedure|sub-pectoral expander-implant breast reconstruction|The tissue expander is inserted without TiLoop Bra mesh in the first stage of reconstruction immediately after nipple/skin-sparing mastectomy. The tissue expander is placed sub-pectoral and covered by muscle/fascia.
15737055|NCT04967963|Procedure|HAM|Transplantation of HAM
15737056|NCT04967950|Drug|Secukinumab 300 MG|Secukinumab 150 mg s.c. with loading dose at baseline, week 1,2,3,4 and then every 4 weeks from week 5 up to 12 weeks. After which, if MASEI ultrasound enthesitis score improvement is less than 50%, Secukinumab 150 mg will be with a switch to 300 mg.
15737057|NCT04967950|Drug|Secukinumab 150 MG|Methotrexate 15 mg po. every week up to 12 weeks. After which, if MASEI ultrasound enthesitis score improvement is less than 50%, methotrexate with a switch to Secukinumab 150 mg at 12 weeks.
15737058|NCT04967950|Drug|Methotrexate|methotrexate
15737059|NCT04967937|Other|Strengthening, resistance exercise, plyometric and dynamic movement training|(1) balance training and hip/pelvis/trunk strengthening, (2) plyometrics and dynamic movement training, and (3) resistance training.
15737060|NCT04967924|Other|neuromuscular training|Treatments will be provided in 30 mins per week for 3 consecutive weeks Proprioceptive Neuromuscular Facilitation (PNF)
15737061|NCT04967924|Other|Sports specific training|Treatments will be provided in 30 mins per week for 3 consecutive weeks. Weight programs include closed chain exercises (squats, pushups) and open chain exercises (leg press, chest fly using dumbbell) Stretch shortening cycle (enhances performance through storage of elastic energy during eccentric phase and activation of stretch reflex).
15737062|NCT04967911|Other|Rhythmic stabilization exercises|"PNF techniques and Conventional Treatment:
~Experimental group received rhythmical Stabilization Technique on shoulder joint on all shoulder movements up to 1 minute in supine position For stability of joint ,re-establish dynamic rotator cuff stability and to enhance MS strength and decrease pain.
~Conventional Treatment: heating pad for 15 minutes, TENS (Transcutaneous Electrical Nerve Stimulation) and after that shoulder stretching of upper trapezius muscle, pectorals and levator scapule and isometric exercises of rotator cuff muscles performed in supine .( 10 sec hold and 10 to 15 reps).."
15737063|NCT04967911|Other|conventional treatment|Conventional Treatment: heating pad for 15 minutes, TENS (Transcutaneous Electrical Nerve Stimulation) and after that shoulder stretching of upper trapezius muscle, pectorals and levator scapule and isometric exercises of rotator cuff muscles performed in supine .( 10 sec hold and 10 to 15 reps)..
15737064|NCT04967898|Other|bowen technique|Bowen technique is a soft tissue mobilization technique. This medical care involves short mild rolling moves over the muscles, nerves, ligaments, and tendons of flesh utilizing the hands, fingers and thumb. Sequence of receiving bilateral rolling moves over segments of the erector spinae from the lumber toward cervical spine, latissimus dorsi, the gluteal, the hamstring muscles proximally and distally, tensor facia Lata and a medial hip striated muscle move.
15737065|NCT04967898|Other|sustained stretching|static stretching is one of the most common and safest technique used for hamstring tightness. A static stretch is performed by inserting muscles at their greatest attainable length and holding that position for an amount of your time.
15737066|NCT04967885|Behavioral|Ecological Momentary Implementation Intentions Intervention (EMI-II)|To reduce smoking, this text messaging intervention will use a self-regulatory strategy, Implementation Intentions (II) to deliver appropriate alternative responses to cigarette smoking. Participants will create personalized II messages before starting the two-week intervention period. Then during the intervention period, after receiving Ecological Momentary Assessments (EMAs), participants will be micro-randomized to receive the EMI-II. During the EMA + EMI-II period, participants will complete five daily EMAs. After approximately 40% of these EMAs, participants will also receive the personalized EMI-II by text messaging.
15737067|NCT04967872|Other|Implementing risk management and control plan for the elderly during perioperative period|Visualization technology is used for preoperative evaluation, anesthesia management, bedside real-time monitoring and intervention, etc., to achieve accurate perioperative management of elderly patients and whole-process whole-person management
15737068|NCT04967859|Drug|0.1% gentamicin|Patient using 0.1% gentamicin ointment at the exit site of the hemodialysis catheter
15737069|NCT04967859|Drug|Placebo|Patients using placebo ointment at the exit site of the hemodialysis catheter
15737070|NCT04967833|Biological|Tumor Infiltrating Lymphocytes (TIL)|Biological: Tumor Infiltrating Lymphocytes (TIL) Adoptive transfer of 1x10^9-3x10^11 autologous TILs to patients i.v. in 30-120 minutes.
15737073|NCT04967807|Diagnostic Test|Blood Biomarkers|Markers of cardiac damage, inflammation, circulating microRNA profiles, and COVID antibody levels will be evaluated in patients after COVID-19 vaccination.
15737074|NCT04967794|Other|Teleorientation and Tooth Brushing Orientation|Guide children in toothbrushing with a preventive purpose during the COVID-19 pandemic
15737075|NCT04967781|Behavioral|autoimmunity|autoimmunity is characterized as self attacking from self immune system, which may involve in the severe progression of COVID-19.
15737076|NCT04967768|Other|Questionnaire about impact of the COVID-19 pandemic on orthopaedic resident training|Answers were collected for the effects of the COVID-19 pandemic on the real-life experiences of orthopaedic residents
15737077|NCT04967755|Drug|Jing-Si-Herbal-Tea|Eligible patients were randomized to receive routine treatment alone based on the Novel Coronavirus Interim Guidelines for Clinical Management of SARS-CoV-2 Infection (Eleventh edition 2021) (control group) or the combination of routine treatment and JSHT (1 drink thrice daily for 7 days) (JSHT group) at the discretion of the attending clinicians. Routine treatment generally consisted of the supportive treatment such as oxygen therapy, antiviral medications and symptomatic therapies. Adherence to the study medications, clinical outcomes, the use of concomitant medications and adverse events were recorded. The following data were collected at admission: demographics, body mass index, smoking history, comorbidities, CURB-65 Score for pneumonia. Hemogram, laboratory testing, chest X-ray, and nucleic acid assays of SARS-CoV-2 were evaluated at admission and after randomization and on 7th day.
15737078|NCT04967742|Biological|UB-612|UB-612 includes a designer S1-RBD-sFc fusion protein formulated with designer Th and CTL epitope peptides selected from immunodominant M, S2 and N regions known to bind to human MHC I and II.
15737079|NCT04967729|Device|Device: Butterfly iQ|The Butterfly iQ is an ultrasound system that enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients. It is a non-invasive device and does not impose any health hazards.
15737080|NCT04967716|Other|basic information|Demographic data registration, medical history inquiry, physical examination; electromyography, nerve conduction velocity examination; CMT nerve function score;
15737081|NCT04967716|Other|venous blood test|The specific method is as follows: 12ml of peripheral blood is drawn from the peripheral vein, and EDTA is used for anticoagulation. No fasting is required before blood draw, and there is no time limit. Part of the specimens submitted for inspection are sent to a qualified genetic testing company for examination, and the fees are charged in accordance with the corresponding charging standards set by the hospital. The remaining part of the sample will be stored or accumulated for a period of time, and the DNA will be extracted and stored in the sample library.
15737082|NCT04967703|Procedure|Group A|Patients received ultrasound therapy protocol with the following parameters (1 MHz frequency, intensity of 1.5 W/cm2 and use of continuous mode of ultrasound for 5 minutes), in addition to a conventional physiotherapy program consisting of calf muscles stretching and plantar fascia stretch for 3 sessions per week, for 4 weeks
15737083|NCT04967703|Procedure|Group B|Patients received radial shock wave therapy protocol with the following parameters (1) the energy level was 0.12 mJ/mm2 equivalent to 2.5 bar intensity, (2) the number of shoots was 2000, (3) the frequency was 8 Hz, in addition to the same conventional physiotherapy program given for group A
15737084|NCT04967703|Procedure|Group C|Patients received both ultrasound and radial shock wave therapy, in addition to the same conventional physiotherapy program given for group A
15737085|NCT04967690|Drug|SI-053|SI-053 will be used as an add-on to SoC for newly diagnosed GBM.In conjunction with surgical resection, SI-053 will be applied intracranially (i.c.) into the cavity that is formed after tumor resection. Post-operative chemoradiotherapy (including concomitant and adjuvant TMZ or following the CeTeG protocol) will be initiated at least 21 and no later than 35 days after SI-053 administration.
15737086|NCT04967677|Diagnostic Test|Nine Hole Peg Test, Purdue Pegboard Test, Box and Block Test|At first, each person will be asked to fill in the questionnaire. Than he/she will be tested by the Nine Hole Peg Test, Purdue Pegboard Test and the Box and Block Test according to the Czech version of extended manuals for those tests. Audio recording of verbal instructions will be used.
15737087|NCT04967664|Drug|Qutenza (capsaicin) 8% topical system|High concentration capsaicin
15737088|NCT04967664|Drug|capsaicin 0.04% topical system|Low-dose capsaicin control
15737089|NCT04967638|Procedure|tumor resection and mandible reconstruction|The patients who underwent primary ablative tumor resection with segmental mandibulectomy and immediate VFF reconstruction were retrieved from the database
15737090|NCT04967625|Drug|Sintilimab|A humanized anti-PD-1 monoclonal antibody
15737091|NCT04967625|Drug|Anlotinib hydrochloride|A tyrosine kinase inhibitor selectively targeting VEGFR-2
15737093|NCT04967599|Behavioral|Phenotype Feedback Intervention|Online session providing information on health-related risk associated with alcohol consumption and alcohol metabolism gene variations plus personalized feedback on flushing phenotype and associated risks.
15737094|NCT04967599|Behavioral|Genotype Feedback Intervention|Online session providing personalized feedback on alcohol metabolism genotypes and associated health-related risks.
15737095|NCT04967586|Other|No intervention, questioner only|questioner only
15737096|NCT04967573|Drug|Rivaroxaban|Rivaroxaban 20 mg or 10 mg for 3 months
15737098|NCT04967547|Other|Self-care PD ability assessment form|Subjects will be evaluated using the self-care PD feasibility assessment tool within 7 days after randomization. The evaluation results will be provided to the patient on the same day
15737099|NCT04967547|Other|Education|Education on renal replacement therapy and dialysis
15737121|NCT04967391|Procedure|Tumescence During STSG Harvest|Tumescence injections performed prior to STSG harvest
15737122|NCT04967378|Behavioral|HEPPI|10 weekly individual sessions, 90 minutes each, at the participants' homes. The content of sessions includes psychoeducation, cognitive training, psychotherapeutic intervention, and compensatory strategy training.
15753490|NCT04830449|Drug|RLD2001-2|Take it once daily for 8 weeks orally.
15737100|NCT04967534|Behavioral|WB-EMS|Simultaneous, individually adjustable stimulation of 12 muscle groups using an interval approach with a duty cycle of 6s impulse/4s rest, bipolar electric current (impulse -frequency 85Hz, -width 350μs, rectangular pattern) will be applied. After a 4-week conditioning period, 1.5x 20 min/week WB-EMS will be conducted for 12 weeks (total training duration 8 weeks). Easy to perform functional exercises focusing on balance, transfer ability, stepping, and lower extremity strength will be done during WB-EMS. Exercise intensity will be individually prescribed and adjusted by the rate of perceived exertion (RPE-Borg CR10 scale 4 (moderate) to 7 (hard)). WB-EMS will be fully supervised one-on-one.
15737101|NCT04967534|Behavioral|social contact control group|Psycho-social intervention with participants randomized to the control group receiving (if wanted) the same social contact time (20-30 minutes/week) as the WB-EMS group. Depending on personal preferences and Covid-19 restrictions this will be done by phone or in-person one-on-one. Health-related topics and/or general chatting will be offered.
15737102|NCT04967521|Drug|Abemaciclib|Abemaciclib will be administered 200mg orally twice a day. Each cycle is 28 days.
15737103|NCT04967521|Drug|Placebo|Placebo will be administered orally twice a day. Each cycle is 28 days.
15737104|NCT04967508|Drug|Stelara® (Ustekinumab)|Subjects randomised into Stelara® group will receive Stelara® (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks up to Week 40.
15737105|NCT04967508|Drug|SB17 (Proposed Ustekinumab Biosimilar)|"Subjects randomised into SB17 group will receive SB17 (45 mg) via subcutaneous injection at Week 0, 4, and then every 12 weeks up to Week 40.
~Starting at Week 28, subjects transited from Stelara® to SB17 will receive SB17 via subcutaneous injection."
15737106|NCT04967495|Procedure|TACE combined with sorafenib/lenvatinib and iodion-125 seeds brachytherapy|TACE will be performed for the patients after randomization. Either sorafenib (400mg P.O. BID) or lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight < 60 kg, 8mg P.O. QD) will be started at 3-7 days after the first TACE according to the patients' own will and last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first. Iodion-125 seeds will be implanted into the PVTT under CT guidance within 14 days after the first TACE. TACE and iodion-125 seeds implantation can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination.
15737107|NCT04967495|Procedure|TACE combined with sorafenib/lenvatinib|TACE will be performed for the patients after randomization and it can be repeated on demand during follow-up based on the evaluation of laboratory and imaging examination. Either sorafenib (400mg P.O. BID) or lenvatinib (body weight ≥ 60 kg, 12mg P.O. QD; body weight < 60 kg, 8mg P.O. QD) will be started at 3-7 days after the first TACE according to the patients' own will and last until disease progresses, intolerable toxicity, withdrawal of informed consent, loss of follow-up, death, or other circumstances that require termination of treatment, whichever occurs first.
15737108|NCT04967482|Procedure|Drug-eluting bead transarterial chemoembolization (DEB-TACE)|The patients will receive DEB-TACE if they choose DEB-TACE as the primary treatment. DC Bead loaded with epirubicin (1 vial of DC Bead loaded with 60 mg of epirubicin) is used for chemoembolization. During follow-up, TACE will be repeated on demand based on the evaluation of the follow-up laboratory and imaging examination, and the technique method of each TACE procedure (i.e. DEB-TACE) for the same patient should be consistent.
15737109|NCT04967482|Procedure|Conventional transarterial chemoembolization (cTACE)|The patients will receive cTACE if they choose cTACE as the primary treatment. An emulsion of epirubicin in lipiodol wiil be injected into the tumor feeding artery. Afterwards, microspheres or polyvinyl alcohol particles mixed with contrast agent will be administered intraarterially until arterial flow stasis was achieved. Generally, the dose of lipiodol and epirubicin should not exceed 30 mL and 60 mg for each procedure. During follow-up, TACE will be repeated on demand based on the evaluation of the follow-up laboratory and imaging examination, and the technique method of each TACE procedure (i.e. cTACE) for the same patient should be consistent.
15737110|NCT04967469|Drug|Calcitriol|end-stage renal failure patients who is hyperparathyroid with ESRD take calcidol preoperative Parathyroidectomy
15737111|NCT04967469|Drug|Alfacalcidol 0.5 MCG Oral Capsule|end-stage renal failure patients who is hyperparathyroid with ESRD take alfacalcidol preoperative Parathyroidectomy
15737112|NCT04967456|Diagnostic Test|Measurement of pulpal blood flow of traumatised tooth|"Measurement of the blood flow of the dental pulp will be performed, using a laser doppler flow monitor mVMS-LDF2TM (Moor Instruments Ltd Millwey Axminster Devon, UK), emission wavelength 785nm±10nm, dual-channel laser Doppler monitoring option. Two probes will be used, each consisting of one afferent and one efferent optic fiber to conduct the light to and from the tooth surface. The probe is stainless steel needle-like tube, which is 10-80 mm long and 1.5 mm in the diameter. The utilised parameter settings will be: Average power - 1.0 mV; Diameter of the probe - 1.5 mm; Frequency - 40 Hz; Monitoring time-180 seconds (sec)"
15737116|NCT04967430|Drug|Peginterferon Lambda-1A|"Peginterferon lambda is a covalent conjugate of human recombinant non-pegylated IFN lambda (IFN L) and a 20-kDa linear PEG chain.
~Peginterferon lambda Injection is a sterile, nonpyrogenic, ready-to-use solution (0.4 mg/mL) that is clear to opalescent, colorless to pale yellow, and essentially free of particles. Lambda Injection is provided in a 1-mL long Type I glass syringe (0.18 mg/syringe) with a staked 29-gauge, 1/2- inch, thin-walled needle. The syringe has a rigid needle shield and is stoppered with a plunger stopper. Syringes are prefilled with a solution of Peginterferon lambda Injection, mannitol, L-histidine, polysorbate 80, hydrochloric acid, and water for injection; they are intended for a single use at adjustable doses. The syringe is marked with dose indicator lines, which are used as a reference point for administering the correct dose."
15737117|NCT04967430|Other|Placebo|The placebo will be 0.9% sodium chloride (normal saline) solution. A plastic 1 mL syringe will be prefilled by the study pharmacy. Each syringe will contain 0.5 mL (0.45 mL to match the volume of the Interferon plus 0.05 mL overfill) to allow for needle priming by the unblinded study nurse.
15737118|NCT04967417|Drug|Pemetrexed, Carboplatin, Pembrolizumab|"Pemetrexed 500mg/m2
~Carboplatin AUC 5.0
~Pembrolizumab 200mg"
15737119|NCT04967417|Drug|Paclitaxel, Carboplatin, Pembrolizumab|"Paclitaxel 200mg/m2
~Caboplatin AUC 6.0
~Pembrolizumab 200mg"
15737120|NCT04967404|Dietary Supplement|Phosphatidylserine|800 mg per day for 10 days
15737123|NCT04967339|Device|Foot deformity correcting insoles|Foot deformity correcting insoles (e.g. insoles with medial arch support for plano-valgus deformity)
15737124|NCT04967339|Device|Lateral wedge insoles|Lateral wedge insoles
15737125|NCT04967326|Drug|Optimizing therapy with antiepileptic drugs (carbamazepine, phenytoin, valproic acid)|
15737126|NCT04967313|Behavioral|Behavioral Change Techniques|"Four behavioral changes techniques (BCTs) will be administered to participants in random order. The BCTs are defined as follows:
~Goal setting: set or agree on a goal defined in terms of behavior to be achieved. Example: Set the goal of walking 2,000 steps more per day.
~Action planning: prompt detailed planning of performance of behavior (must include a setting [walking to the mailbox], frequency, duration, and intensity. Example: Develop a plan to walk today.
~Self-Monitoring of behavior: establish a method for person to monitor and record their number of steps based on their Fitbit. Example: Did you check your Fitbit and record daily total number of steps?
~Feedback on behavior: Monitor and provide informative or evaluative feedback on performance of the behavior (e.g. form, frequency, duration, intensity). Example: You walked 6,000 steps today. This is 1,000 steps above your baseline."
15737127|NCT04967300|Procedure|Dental treatment|bilateral restorative treatment on the mandibular primary first molars
15737130|NCT04967274|Procedure|Startling acoustic stimulus|StartReact: involuntary triggering of a planed movement by a loud acoustic stimulus.
15737131|NCT04967248|Other|Alpelisib|Prospective observational PASS study. There is no treatment allocation. Patients recruited on or before their first prescribed dose of alpelisib in combination with fulvestrant will be enrolled.
15737132|NCT04967248|Other|Fulvestrant|Prospective observational PASS study. There is no treatment allocation. Patients recruited on or before their first prescribed dose of alpelisib in combination with fulvestrant will be enrolled.
15737133|NCT04967235|Other|Conventional Exercise-based Cardiac Rehabilitation Session|"This session will be composed of:
~I.10 minutes of initial rest in the supine position; II. 15 minutes of warm-up through stretching and global exercises; III. 30 minutes of treadmill aerobic exercise at an intensity of 60-80% of the heart rate reserve for those without diabetes Mellitus and 40-70% of the heart rate reserve for those diagnosed with diabetes mellitus; IV. 1 minute passive recovery in orthostatic position; V. 30 minutes of passive recovery in the supine position."
15737134|NCT04967235|Other|Dance-based Cardiac Rehabilitation Session|I.10 minutes of initial rest in the supine position; II. 15 minutes of warm-up through stretching and global exercises; III. 30 minutes of dance therapy. The intensity of the choreography will be set at the same range as the conventional exercise-based session. (60-80% of the heart rate reserve for those without diabetes Mellitus and 40-70% of the heart rate reserve for those diagnosed with diabetes mellitus); IV. 1 minute passive recovery in orthostatic position; V. 30 minutes of passive recovery in the supine position.
15737135|NCT04967222|Behavioral|Cognitive Reappraisal by Distancing|Reappraisal-by-distancing treatment. Participants meet 2 times a week for 6 weeks to learn reappraisal by distancing through repeated practice with negative emotional pictures. The therapist will help model and shape the technique. .
15737136|NCT04967222|Behavioral|Control Downregulate Condition|Participants either meet 2x a week for 6- weeks to gain added practice, under the guidance of a therapist, using their customary emotion regulatory strategies to downregulate their negative reactions to aversive pictures.
15737137|NCT04967196|Biological|Ipilimumab|Given via DoseConnect device or IV
15737138|NCT04967196|Biological|Nivolumab|Given IV
15737139|NCT04967183|Diagnostic Test|Annual FIT|"Patients will be offered an annual FIT and colonoscopy will be performed if fecal hemoglobin concentration is ≥10µg / g of feces. After performing a colonoscopy the FIT will be sent to the patient:
~After one year if the unscheduled colonoscopy has been incomplete or a lesion requiring endoscopic surveillance has been completely resected.
~After five years if the colonoscopy has evaluated the entire mucosa, it is normal or with lesions that do not require endoscopic surveillance (1-2 non-advanced adenomas)."
15737140|NCT04967183|Procedure|Endoscopic surveillance.|First surveillance colonoscopy will be performed in three-year time. If an advanced adenoma or at least three non-advanced adenomas are detected, colonoscopy will be repeated after 3 years. In contrast, if colonoscopy is normal or 1-2 non-advanced adenomas are detected, colonoscopy will be repeated after 5 years.
15737141|NCT04967170|Biological|Autologous Platelet-Rich Plasma (PRP)|Two intralesional injections of approximately 5-6mL given approximately 6 weeks apart
15737142|NCT04967170|Other|Sham Procedure|Intralesional needle insertion without any injectate.
15737143|NCT04967157|Dietary Supplement|Placebo supplement|Cellulose
15737144|NCT04967157|Dietary Supplement|Citicoline supplement|Cognizin®
15737145|NCT04967144|Diagnostic Test|Nerve conduction study|"Participants with carpal tunnel syndrome will consist of individuals whose diagnosis has been confirmed by an electrophysiological study.
~Participants in the control group will consist of those who have been confirmed not to have carpal tunnel syndrome by nerve conduction study."
15737146|NCT04967144|Diagnostic Test|Montreal Cognitive Assessment Test|Montreal Cognitive Assessment Test evaluates eight separate cognitive functions. Thirty is the highest score. The scores equal to or above 26 are considered normal cognitive function.
15737147|NCT04967131|Other|PNF exercises|PNF exercises were applied in 3 sets of 15 repetitions based on movement in the diagonal plane, using head, neck and chin patterns. Contractions were sustained for at least 10 seconds.
15737148|NCT04967118|Behavioral|Skin-to-skin contact|Diaper clad baby will be placed ventral position on bare chest of mother 30 minute prior to the heel lance
15737149|NCT04967118|Behavioral|Mother's heartbeats as sound and vibration|The mother's heartbeat will be recorded and the heartbeat sounds will be saved to the platform. The platform will be placed under the infant's mattress and the heartbeat will be started 30 minute prior to the heel lance.
15737150|NCT04967118|Drug|30% oral glucose|The infant will be given 30% oral glucose solution 2 minutes before the injection
15737151|NCT04967105|Device|Near-infrared spectroscopy|Before the induction of anesthesia, NIRS sensors were placed on both sides of the flank area that overlies the kidney to monitor renal SO2, whose alteration trends over time during operation will be recorded and evaluated in later analysis.
15737152|NCT04967092|Drug|Modified Xiao-Feng Powder + Antiallergics|Modified Xiao-Feng Powder granules twice daily for 12 weeks plus Bilastine 20mg once daily for the first 6 weeks, and on-demand for the following 6 weeks.
15737153|NCT04967092|Other|Placebo + Antiallergics|Placebo granules twice daily for 12 weeks plus Bilastine 20mg once daily for the first 6 weeks, and on-demand for the following 6 weeks.
15737154|NCT04967079|Drug|Trametinib|Trametinib 2 mg given orally, once daily
15737155|NCT04967079|Drug|Anlotinib|Anlotinib capsules given orally, dose ranging from 8 mg to 12 mg once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21). Initial dose is 10 mg. If there are no patients with DLT in first treatment cycle , begin to explore dose of 12 mg. If there are 2 or more patients in 3 patients with DLT, 8 mg dose is to explore.
15737156|NCT04967066|Diagnostic Test|Serum Levels of Adipocytokines|Serum leptin, adiponectin, and IL6: venous blood samples (3 ml) will be obtained from children with FS (within 3 hours of seizures) as well as the two control groups. Serum will be obtained by centrifugation at 3,500 rpm for 5 min at 4 ℃. The serum will be immediately separated and stored at -70 ℃. Serum leptin, adiponectin, and IL6 will be assessed through enzyme-linked immunosorbent assay (ELISA) kits according to the manufacturer's instructions.
15737157|NCT04967053|Procedure|sleeve gastrectomy|Laparoscopic sleeve gastrectomy gives long-standing improvement or resolution of obesity-related conditions and also survival benefit. It is highly cost-effective. Surgical procedures for the treatment of obesity.
15737158|NCT04967040|Procedure|medial plantar artery flap|Medial plantar artery flap is a fasciocutaneous island flap raised from the non-weightbearing instep of the plantar foot. The dominant vascular pedicle of the flap consists of the medial plantar artery and venae comitantes
15737159|NCT04967040|Procedure|Distally based sural artery flap|Distally based sural artery flap is a fascio-cutaneous island flap taken from the posterior aspect of the middle third of the leg and fed by the lower peroneal septo-cutaneous perforators in reverse fashion. Its vascular basis is the close association between the median superficial sural artery and peroneal artery perforators
15737160|NCT04967027|Device|ASCLU-300 TTF|BM treated by continuous TTFields treatment (ASCLU-300, approved by Chinese FDA)
15737161|NCT04967014|Drug|HIP2101|Test drug
15737162|NCT04967014|Drug|RLD2101|Reference drug
15737163|NCT04967001|Diagnostic Test|PSMA PET|68Ga-PSMA PET
15737164|NCT04966975|Other|neoadjuvant chemotherapy|The patients receive neoadjuvant chemotherapy for 2-4 cycles before surgery.
15737165|NCT04966962|Diagnostic Test|serum and urine metabolomics|serum and urine samples will be collected for metabolomics analysis
15737166|NCT04966949|Procedure|lateral prostate capsule sparing or neurovascular bundles sparing|When resect the bladder and prostate, the lateral prostate capsule or neurovascular bundles will be preserved.
15737167|NCT04966936|Other|questionnaires for clinical assessments|Amputee Mobility Predictor, Locomotor Capacity Index, visual analog scale (VAS)
15737168|NCT04966936|Other|2 minute walking test|the individual is asked to walk in his natural course within 2 minutes on a track whose distance is measured beforehand, and at the end of two minutes, the distance he walks will be recorded in meters (m).
15737169|NCT04966936|Other|The gait analysis at the motion analysis laboratory.|Temporo-spatial parameters (gait speed (m/s), cadence (step/s), other foot contact (%), double support time (second), single support time (second), stance phase time (sec), swing phase time (sec), stride length (meters)) and kinematic parameters (hip, knee, ankle joint angles (frontal, sagittal, transverse plane), maximum knee flexion angles in the stance and swing phase, velocity-dependent maximum knee flexion angles in the swing phase, knee flexion moments will be compared
15737170|NCT04966923|Other|No intervention in this study|Analyses of pathogenic variant TP53 and variants in genetic test
15737171|NCT04966910|Behavioral|Stay Connected|Stay Connected is a menu-driven set of strategies to combat loneliness, anxiety and depression in older adults based on behavioral activation principles.
15737172|NCT04966910|Behavioral|Treatment as usual|Regular check-ins, resource/referral provision
15737173|NCT04966897|Dietary Supplement|GlycosBio Nutritional Supplement + PERT placebo|"The lipid (fat) in the GlycosBio Nutritional Supplement (GBNS) was provided in the form of a re-structured lipid monoacylglyceride (MAG) produced by the study sponsor. MAGs are readily absorbed by enterocytes without the need of digestion by pancreatic lipases. The MAG oil is produced enzymatically from almond oil. The product also contains essential amino acids, carbohydrates as simple sugars and fat-soluble vitamins and minerals. The GBNS to be administered in a volume sufficient to supply 0.5 g of MAG per kg of body weight"
15737174|NCT04966897|Dietary Supplement|Standard Nutritional Supplement + PERT|A 5.9% fat triacylglycerol-based commercially available nutritional supplement (Boost Plus®, Nestlé Health Science, Bridgewater, NJ) in a volume sufficient to supply 0.5 g of TAG per kg of body weight over the same time period and PERT capsules (24,000 iu/capsule) at a dose of 2,500 iu of lipase activity per gram of fat ingested.
15737175|NCT04966884|Drug|JAK Inhibitor|"Prednisone 0.8-1.0 mg/kg/d, the dose was gradually reduced, and after 4 weeks, the dose was reduced by 5mg every two weeks, and then reduced to 10mg/d for 4-6 months after oral administration for 3 months, and then reduced to 7.5mg/d for maintenance therapy until 12 months;
~Tofacitinib 5 mg twice daily for 12 months."
15737176|NCT04966871|Biological|PfSPZ Vaccine|Metabolically active, non-replicating, radiation attenuated, aseptic, purified, cryopreserved NF54 P. falciparum (Pf) sporozoites (PfSPZ Vaccine)
15737177|NCT04966871|Biological|PfSPZ Challenge (7G8) for CHMI|Live, infectious, aseptic, purified, vialed, cryopreserved, Plasmodium falciparum sporozoites, strain 7G8
15737178|NCT04966871|Other|Normal Saline|normal saline placebo control
15737179|NCT04966858|Other|Individualized Caloric Refeeding (ICR)|Meal-based refeeding in hospital, starting at 50 calories per kilogram of body weight, and increasing by 200 calories per day until caloric goal achieved
15737180|NCT04966858|Other|Higher Calorie Refeeding (HCR)|Meal-based refeeding in hospital, starting at 2000 calories per day, and increasing by 200 calories per day until caloric goal achieved
15737181|NCT04966845|Diagnostic Test|measurement of concentration on exhaled Carbon Monoxide|Εxhaled carbon monoxide (eCO) concentration [parts per million (ppm) was measured by a specific device [Bedfont Scientific, Maidstone, Kent UK]
15737182|NCT04966832|Drug|XW10508|XW10508 capsules or tablets
15737183|NCT04966832|Other|Placebo|Placebo capsules or tablets
15737245|NCT04966312|Other|Preoperative educational videos plus routine education|Mothers receiving routine education plus digital video disk before their children receiving congenital heart disease surgery. The content was the same as the routine education but was presented audio-visually, and the video was easy to understand by the general public.
15737184|NCT04966819|Other|Survivorship Care Initiative|"The survivorship initiative will consist of:
~(A) Regular meetings with the rectal cancer oncology pivot nurse (IPO). These meetings present an opportunity for patients to discuss any treatment-related distress or late and long-term side-effect.
~(B) Identification of a primary care physician. If the patient is not known to a Primary care physician (PCP), the IPO will add the patient to an accelerated waitlist.
~(C) Development of an individualized survivorship plan. During meetings with the oncology pivot nurse, a survivorship care plan will be populated, included information on patient risk factors, treatments completed, pathology findings, and future surveillance planned. This document will be reviewed by the treating colorectal surgeon, and will be subsequently shared with the oncology team, the PCP and the patient (if the patient desires).
~(D) Educational resources for patients. Patients will be offered educational materials to help address their specific needs."
15737185|NCT04966806|Procedure|LASIK refractive surgery|laser vision correction for myopic eyes
15737186|NCT04966780|Procedure|acute abdominal surgery|Acute surgery for acute abdominal disease
15737187|NCT04966741|Drug|Setmelanotide|All patients will begin treatment at a dose of 0.5 mg of setmelanotide per day. Patients will then increase their dose by 0.5 mg increments, every 2 weeks. The dose of setmelanotide used in this study will be based on the weight bands for the 2- to <6-year-old patients to ensure the exposure is similar to that observed for adults dosed at 2 to 3 mg setmelanotide once daily. The highest dose in this study for patients who weigh <20 kg, 20 to <30 kg, 30 to <40 kg and ≥40 kg will be 0.5 mg, 1.0 mg, 1.5 mg and 2.0 mg per day.
15737188|NCT04966728|Diagnostic Test|conventional ultrasound diagnosis of the hip joint, contrast-enhanced ultrasound, and high-resolution single hip MRI|conventional ultrasound diagnosis of the hip joint, contrast-enhanced ultrasound, and high-resolution single hip MRI
15737189|NCT04966715|Procedure|Epigastric lymph node biopsy|epigastric lymph node biopsy and analysis to evaluate rate dissemination of colorectal carcinomatosis by this way
15737190|NCT04966702|Drug|Albendazole Pill|Using a MDA approach, fieldworkers will admister albendazole using directly observed treatment methodology to participants
15737191|NCT04966702|Drug|Ivermectin Pill|Using a MDA approach, fieldworkers will admister ivermectin using directly observed treatment methodology to participants
15737192|NCT04966702|Drug|Ivermectin Injectable Product|Veterinary ivermectin injectable will be given to livestock in the relevant cluster
15737193|NCT04966689|Behavioral|combined speech and music therapy|he telerehabilitation intervention that include both speech therapy and music therapy at the same time
15737194|NCT04966689|Behavioral|speech therapy|A behavioural speech therapy program including breathing exercises, loudness, pitch, and intelligibility which are adapted from Lee Silverman Voice Treatment (LSVT) and voice exercises Which is delivered through telerehabilitation
15737195|NCT04966689|Behavioral|music therapy|music exercises Will be designed based on the music therapy protocols of previous studies Which is delivered through telerehabilitation
15737196|NCT04966676|Diagnostic Test|cfDNA blood test|Blood sample will be taken for cfDNA testing
15737197|NCT04966676|Drug|Nivolumab|Antineoplastic agent
15737198|NCT04966676|Drug|Ipilimumab|Antineoplastic agent
15737199|NCT04966676|Combination Product|Platinum-based Chemotherapy|May include carboplatin with gemcitabine, or paclitaxel or pemetrexed
15737200|NCT04966663|Drug|Nivolumab|Antineoplastic agent
15737201|NCT04966663|Drug|Pemetrexed|Antineoplastic agent
15737202|NCT04966663|Drug|Gemcitabine|Antineoplastic agent
15737203|NCT04966663|Drug|Cisplatin|Antineoplastic agent
15737204|NCT04966663|Drug|Carboplatin|Antineoplastic agent
15737205|NCT04966663|Procedure|ctDNA blood test|Blood will be collected for ctDNA testing
15737206|NCT04966650|Behavioral|5-mins brief nursing advice incorporating with Social Cognitive Theory (SCT)|The protocol is about the relationship between exercise and mental health, the advantages of increase physical activity and regular exercise, and highlight the consequence if not deal with the depressive symptoms.
15737207|NCT04966637|Other|COPD cohort|as this a retrospective descriptive study no intervention will be administered to study participants
15737208|NCT04966624|Procedure|"LUVS ventilatory strategy composed of a bundle of measures"|Ventilation in APRV mode early prone sessions, adjustment of positive expiratory pressure according to the patient's BMI and no curarization
15737209|NCT04966624|Procedure|Ventilatory management according to international recommendations (Société de Réanimation de la Langue Française)|Ventilatory management according to international recommendations (Société de Réanimation de la Langue Française)
15737210|NCT04966611|Drug|Anlotinib|This is an observational study
15737211|NCT04966585|Drug|Posaconazole Delayed Release Oral Tablet|Three 100mg delayed-release tablets twice a day on the first day, then three 100mg delayed-release tablets once a day, starting on the second day. Duration of therapy will be 12 weeks.
15737212|NCT04966585|Drug|Matching Placebo Tablet|Three matching placebo tablets twice a day on the first day, then three tablets once a day, starting on the second day. Duration of therapy will be 12 weeks.
15737213|NCT04966572|Device|Presurgical vacuum formed nasoalveolar molding aligners|at first visit, the infants will receive this appliance which is a maxillary vacuum plate incorporated with palatal screw, the infant's parents will be instructed to activate the screw and apply horizontal tap which will be placed at the base of nose in order to approximate lip segments and to change tape daily. After that, The infants will be recalled one week after the first visit to add the nasal stents into the appliance.
15737214|NCT04966572|Device|Conventional Grayson acrylic formed nasoalveolar molding appliances|"at first visit, the infants will receive this appliance which is a maxillary acrylic plate without adding taping, the infants will be recalled bi weekly for activating the appliance.
~When the cleft alveolar gap is reduced to 6mm or less, a pair of nasal stents will be added to mold the nasal cartilage. the infants will be followed up for 4-6 months."
15737215|NCT04966559|Drug|Placebo treatment|Active drug/placebo is handed out equivalent of 1 tablet of 0,2 mg Naldemedine or placebo daily for 365 days.
15737216|NCT04966559|Drug|Naldemedine 0.2 MG Oral Tablet|Active drug/placebo is handed out equivalent of 1 tablet of 0,2 mg Naldemedine or placebo daily for 365 days.
15737217|NCT04966546|Drug|Memantine Hydrochloride|Active drug arm
15737218|NCT04966546|Drug|Placebo|Simple syrup with peppermint oil added to match the commercial solution and make it indistinguishable
15737470|NCT04964349|Drug|Corticosteroids Acting Locally|topical application of jessener solution
15737219|NCT04966520|Other|Accelerated repetitive intermittent theta-burst transcranial stimulation (iTBS)|"Accelerated iTBS will be used to stimulate the regions of interest of mPFC and L-DLPFC nodes in cancer survivors or patients.
~Accelerated iTBS will be administered in a single half-day period to allow for a 50minutes interval between any two treatments to minimize interference effects between treatments. Thus, there will be ~10 minute sessions of stimulation x 2 applications per node x 2 nodes (L-DLPFC, mPFC) = 40 total minutes of daily stimulation - each session delivers 1800 pulses in a 5 Hz triplet burst frequency, 2 second trains with intertrain interval of 8 seconds; triplets occur with 50 Hz frequency, as per standard iTBS protocols for depression treatment. The treatment will be offered for five consecutive days."
15737220|NCT04966507|Drug|Listerine Antiseptic Mouthwash Product|COOL MINT LISTERINE® Antiseptic Mouthwash will be used as the 'active' study drug condition. This is a commercially available, over the counter mouthwash product. Active ingredients for this product include Eucalyptol 0.092%, Menthol 0.042%, Methyl salicylate 0.060%, Thymol 0.064%. This product also contains 21% alcohol. Participants will be asked to rinse and gargle their mouth with 20mL of mouthwash daily.
15737221|NCT04966507|Drug|Biotene Mouthwash|Biotène Rinse is designed with a moisturizing formula to help relieve dry mouth symptoms and is specifically designed to have a pH similar to saliva. This is a commercially available, over the counter mouthwash product. Biotène Mouthwash Ingredients include: Purified Water, Propylene Glycol, Hydrogenated Starch Hydrolysate, Poloxamer 407, Hydroxyethylcellulose, Sodium Benzoate, Flavor (Peppermint Oil), Benzoic Acid, Disodium Phosphate, Zinc Gluconate, Lactoferrin, Lysozyme, Lactoperoxidase, Potassium Thiocyanate, Aloe Vera Gel, Calcium Lactate, Glucose Oxidase. Participants will be asked to rinse and gargle their mouth with 20mL of mouthwash daily.
15737222|NCT04966494|Dietary Supplement|BOSB|BOSB consisted on a oats (26 %), common beans (30 %), water and emulsifier-based snack bar, administered daily (50 g/day) during 8 weeks.
15737223|NCT04966481|Drug|Palbociclib|Administered on an outpatient basis
15737224|NCT04966481|Drug|Cetuximab|Given intravenously over approximately 60 minutes
15737225|NCT04966468|Device|Virtual Reality|The Lenovo Mirage Solo Headset will be kept at home by the patient for the duration of the study (4 days). The VR headset will be equipped with 10 non-interactive videos and a short interactive game. The videos and the game are characterized by relaxing scenarios. The game will require the active interaction of the patient. At the end of the observational period, the investigator will download the usage data to detect information about the patient's use. Before and after each use of the VR headset, the patient will be asked to fulfil the Edmonton Symptom Assessment Scale (ESAS). On T0, the patient will be asked to wear a wearable device, the Empatica E4 wristband measuring physiological parameters. On day T1, the patient will return the VR headset and the wristband to the investigator and will fulfil again the HADS and BPI questionnaires.
15737226|NCT04966468|Other|Control|"The investigator will illustrate to the patient how to use the tablet for watching videos, suggesting using it especially in moments of psycho-physical discomfort. The tablet will be given to the patient for the duration of the study (four days). The tablet will be equipped with 10 non-interactive 2D videos characterized by relaxing settings with natural or artistic scenarios, giving a passive use to the patient. Before and after each use of the tablet, patient has to fullfil the ESAS digitally inserted into the tablet. Patient can answer by selecting the answer on the touchscreen. Without filling the scale, the patient will not be able to access the videos inserted in the tablet. On day T1, patient will return the tablet to the investigator and fill out the HADS and BPI questionnaires."
15737227|NCT04966455|Dietary Supplement|Raisins|Daily supplementation of 50 g of rainsins for 3 months
15737228|NCT04966442|Behavioral|GrandAides|Enhanced post acute care for patients recently admitted for congestive heart failure
15737229|NCT04966429|Drug|Maraviroc|Tablets
15737230|NCT04966416|Dietary Supplement|Pyrophosphate|50 mg/kg bwt once daily in gelatine capsules.
15737231|NCT04966416|Dietary Supplement|Placebo|Glucose in gelatine capsules.
15737232|NCT04966403|Other|Standard physical therapy|building strength, enhancing developmental skills, boosting balance, coordination, and postural control
15737233|NCT04966403|Other|trampoline-based stretch-shortening cycle exercises|muscle strength
15737234|NCT04966377|Behavioral|Nurse Navigation Program Based On Health Belief Model In Breast Cancer Screening (NaHeB-CaS)|Nurse Navigation Program Based On Health Belief Model In Breast Cancer Screening (NaHeB-CaS), increasing awareness of Syrian women under temporary protection against breast cancer, decreasing their perception of barriers to screening tests, developing early diagnosis behaviors (such as BSE, CBE and mammography), increasing their self-efficacy and breast cancer fears are expected to be reduced.
15737235|NCT04966364|Device|hypotension prediction index guided|patients receiving hypotension prediction index monitoring and let the anesthesiologist' alerted the coming intraoperatiobe hypotension
15737236|NCT04966364|Device|without hypotesion prediction index guided|patients receiving usual care without hypotension prediction index monitoring but with usual arterial line care
15737237|NCT04966351|Behavioral|Time-restricted feeding|Each subject will participate in both conditions (CM and CM+TRF)--one in which food is allowed during the nighttime period and one in which food will be restricted to the daytime only. Food intake will be matched across conditions and designed to keep participants weight stable.
15737238|NCT04966351|Behavioral|Circadian Misalignment|Healthy lean subjects will undergo circadian misalignment induced using a simulated night shift-work protocol in both conditions of the study. Each condition will last approximately 6 days.
15737239|NCT04966338|Biological|Ocrelizumab (CinnaGen, Iran)|Ocrelizumab (CinnaGen, Iran) will be administered via intravenous (IV) infusion.
15737240|NCT04966338|Biological|Ocrelizumab (Roche, Switzerland)|Ocrelizumab (Roche, Switzerland) will be administered via intravenous (IV) infusion.
15737241|NCT04966325|Drug|LC350189 200mg|Subject will receive an LC350189 200mg as single-dose on Day 1(Period 1) or Day 5(Period 2) or Day 9(Period 3) or Day 13(Period 4)
15737242|NCT04966325|Drug|Placebo|Subject will receive a Placebo as single-dose on Day 1(Period 1) or Day 5(Period 2) or Day 9(Period 3) or Day 13(Period 4)
15737243|NCT04966325|Drug|Moxifloxacin 400mg|Subject will receive a Moxifloxacin 400mg as single-dose on Day 1(Period 1) or Day 5(Period 2) or Day 9(Period 3) or Day 13(Period 4)
15737244|NCT04966325|Drug|LC350189 600mg|Subject will receive an LC350189 600mg as single-dose on Day 1(Period 1) or Day 5(Period 2) or Day 9(Period 3) or Day 13(Period 4)
15737246|NCT04966312|Other|Preoperative routine education|Mothers receiving routine education before their children receiving congenital heart disease surgery
15737247|NCT04966299|Dietary Supplement|Eryhtritol|Eryhtritol-sweetened beverages twice a day (36g erythritol/day) with main meals during 5 weeks
15737248|NCT04966299|Dietary Supplement|Sucrose|Sucrose-sweetened beverages twice a day (25g sucrose/day) with main meals during 5 weeks
15737249|NCT04966286|Other|multimedia education|The MLEP intervention was based on a literature review of prior research on the content and format of self care related multimedia education programmes
15737250|NCT04966273|Device|Microcatheter|Only to be used if Biosensor Microcatheter does not perform accordingly
15737251|NCT04966260|Other|Standardized Virtual Reality|This is a one session intervention, where participants will be asked to wear a VR headset and view a three-dimensional standard VR video. The activity session will be approximately 15 minutes in length. Prior to starting the intervention, the therapeutic recreation staff will explain the activity and familiarize participants with the VR headset.
15737252|NCT04966260|Other|Control|This is a one session intervention, where participants will be asked to view a two-dimensional video on an iPad. The activity session will be approximately 15 minutes in length. Prior to starting the activity session, the therapeutic recreation staff will explain the activity.
15737253|NCT04966260|Other|Personalized Virtual Reality|This is a one session intervention, where participants will be asked to wear a VR headset and view a three-dimensional personalized VR video. The activity session will be approximately 15 minutes in length. Prior to starting the intervention, the therapeutic recreation staff will explain the activity and familiarize participants with the VR headset.
15737254|NCT04966247|Other|Microdialysis|Monitoring real-time cerebral biomarkers using microdialysis method
15737255|NCT04966234|Drug|Posaconazole 100 MG [Noxafil]|"Posaconazole is a lipophilic, highly permeable triazole, which is practically insoluble in water. Posaconazole inhibits the enzyme CYP51a (also known as Erg11p or lanosterol demethylase). This enzyme is required for catalysation of an essential step in biosynthesis of ergosterol in filamentous fungi and yeasts.
~Posaconazole is favoured over itraconazole and voriconazole with respect to palatability, tolerability and toxicity profile"
15737256|NCT04966234|Drug|Posaconazole 40 MG/ML|"Posaconazole is a lipophilic, highly permeable triazole, which is practically insoluble in water. Posaconazole inhibits the enzyme CYP51a (also known as Erg11p or lanosterol demethylase). This enzyme is required for catalysation of an essential step in biosynthesis of ergosterol in filamentous fungi and yeasts.
~Posaconazole is favoured over itraconazole and voriconazole with respect to palatability, tolerability and toxicity profile"
15737257|NCT04966221|Diagnostic Test|Lung MRI scan|Participants will have a combination of structural and functional lung MRI scans. These scans will involve lying in a conventional MRI scanner while free breathing and may include additional breathing manoeuvres such as temporarily holding breath.
15737258|NCT04966208|Procedure|xenogeneic collagen matrix|xenogeneic collagen matrix called mucoderm used for root coverage for treatment of gingival recession instead of harvesting from the patients connective tissue
15737259|NCT04966195|Radiation|stereotactic body raiotherapy|stereotactic body radiotherapy of hepatocellular carcinoma patients with portal vein tumor thrombosis
15737260|NCT04966169|Device|GentleWave System|The GentleWave hydrodynamic cavitation system is a 510k FDA-approved multisonic energy system that is used in complex root canal procedures.
15737261|NCT04966156|Behavioral|CaRE-4-alloBMT plus usual care group|CaRE-4-alloBMT uses emerging eHealth technologies to reduce barriers to accessing and providing cancer rehabilitation which includes: 1) Individualized progressive exercise prescriptions that allows customizable exercise prescriptions, tracking of exercise completion, and video tutorials; 2) Individualized nutrition plans and stepped stratified care such as education, counselling, intervention based on nutritional status and delivered by registered dietitians; 3) On-line e-modules provide interactive education to promote self-management skills for stress management, nutrition, managing common symptoms, etc.; 4) Remote monitoring using FitbitTM devices to monitor patients physical activity, caloric intake, and sleep for duration of the program. CRS and alloBMT clinicians will have access to real-time Fitbit data through our clinical dashboard; 5) Remote clinical support: check-ins and health coaching sessions with a member of the CRS team (phone or MS Teams video).
15737262|NCT04966143|Biological|LY011|Targeting CLDN 18.2 Car-T injection
15737263|NCT04966117|Behavioral|Risk-Guided DMP|"Patients will be assigned a cardiac nurse to help manage their heart condition who will:
~develop a care plan and communicate with the patients' General Practitioner (GP) and cardiologist about management, particularly medications to help control risk factors.
~provide health coaching at pre-specified times over 12 months via telehealth (phone or video call) to ensure that patient's take their medications as prescribed and to give health education and guidance on lifestyle changes.
~facilitate cardiac rehabilitation via a smart phone or tablet app (called SmartCR). This app monitors health and physical activity, has prompted tasks to do and delivers education via video, audio and written articles. The information from this app can be used by the cardiac nurse during telehealth follow-up.
~invite participation to a supervised 6-week group exercise program which will require using our on-site gym."
15737264|NCT04966117|Behavioral|Usual Care|Usual care patients will receive standard cardiology care as scheduled that includes adherence to guideline-based care (medications and physical activity), education (self-care), a treatment plan to manage co-morbidities, early post-discharge follow-up/support and routine preventative care.
15737265|NCT04966104|Behavioral|ODYSSEE-vCHAT|Automated digital counselling program with social network support
15737266|NCT04966091|Other|Completion of questionnaires|The quality of life questionnaire will be completed before starting the treatment and then during the embryo transfer and will be followed up at each embryo transfer over a maximum period of 18 months. We will also evaluate by means of a specific questionnaire the importance of work/life interactions management and consequences of absenteeism at work, consequences on professional evolution, anxious repercussions in the professional and private domains).
15737267|NCT04966078|Procedure|liposuction|suction-assisted liposuction
15737268|NCT04966078|Procedure|surgical excision|periareolar surgical excision
15737269|NCT04966065|Device|Parietex Parastomal mesh|Laparoscopic Modified Sugarbaker technique for repair of parastomal hernias in end-colostomies
15737270|NCT04966052|Other|No intervention|No intervention
15737271|NCT04966039|Other|No intervention.|There was no intervention.
15737272|NCT04966026|Other|No inervention|No inervention
15737275|NCT04966000|Behavioral|Prism Adaptation Therapy|Participants wear goggles with built-in prisms (a 20-diopter lens) that shift the visual scene to the right. While wearing the googles they reach to and cross out 60 lines/circles, requiring them to learn to reach more leftward than the visual targets appear. Participants can only see the end of their movements.
15737276|NCT04965987|Drug|Oxaloacetate|Oxaloacetate (OAA) is a four-carbon molecule involved in many metabolic pathways, including gluconeogenesis, citric acid cycle, glyoxylate cycle, urea cycle, and amino acid metabolism. In the glyoxylate and citric acid cycles, oxaloacetate is formed as the result of the catalysis by malate dehydrogenase. In this reaction, the hydrogen atoms from malate are transferred to NAD+, forming NADH, H+ and oxaloacetate. Oxaloacetate can be converted to citrate with the addition of acetyl-CoA by the enzyme citrate synthase. Oxaloacetate is a critical component in the production of ATP and must be constantly regenerated in order for the citric acid cycle and the electron transport chain to continue
15737277|NCT04965987|Drug|Placebo|Placebo
15737278|NCT04965974|Device|Digital blue light blocking filter|digital blue light blocking filter will be given to 80 dry eye subjects in mobile phones and laptops and 80 individuals will be without filters digital devices users
15737279|NCT04965961|Drug|EPO|Please refer to the arm description
15737280|NCT04965961|Other|Control group - saline injection|Please refer to the arm description
15737281|NCT04965948|Other|Novel food snack|Consumption of snack enriched with camelina sativa oil, twice a day for 12 weeks
15737282|NCT04965948|Other|Placebo snack|Consumption of placebo snack (no enriched with camelina sativa oil), twice a day for 12 weeks
15737283|NCT04965935|Drug|Dapagliflozin 10 MG Oral Tablet|Dapagliflozin will be administered in a dose of 10 mg/day for 12 weeks.
15737284|NCT04965935|Drug|Placebo Matching Dapagliflozin Oral Tablet|Placebo will be administered for 12 weeks.
15737285|NCT04965922|Behavioral|Multimodal intervention|"The intervention consists of identifying the individual needs of each caregiver and patient and identifying sources of improvement in the management of daily life, including the optimization of social support. This optimization requires the involvement of people in the environment (family, friends, neighbours) who can provide help, support of any kind, recurrent or punctual, minimizing negative family interactions and maximizing positive contributions by each in supporting and supporting the individual.
~The intervention is personalized in the sense that the content of each session seeks to adapt itself to the specificities of the couple situation and its surroundings.
~interviews/meetings involving a psychologist social worker."
15737287|NCT04965896|Other|Control meal|Participants will receive plain white rice (75g of available carbohydrate) alongside a snack with crackers and cheese. The meal is similar in energy and macronutrients to the test meal.
15737288|NCT04965896|Other|Nut meal|Participants will receive plain white rice (75g of available carbohydrate) alongside a portion of 30g of nuts. The meal is similar in energy and macronutrients to the control meal.
15737289|NCT04965883|Procedure|Excision and Grafting|reconstruction of deep burn by grafting
15737290|NCT04965883|Procedure|dressing then delayed grafting|multiple dressing and delayed grafting
15737291|NCT04965870|Drug|Trifluridine/Tipiracil|Trifluridine/ Tipiracil is an oral combination of an antineoplastic thymidine-based nucleoside analogue, trifluridine, and the thymidine phosphorylase (TPase) inhibitor, tipiracil hydrochloride.
15737292|NCT04965857|Diagnostic Test|Hologic's Genius Digital Diagnostics System|Genius Digital Diagnostics is a digital cytology platform to combine a new artificial intelligence (AI) algorithm with advanced volumetric imaging technology to help cytotechnologists and pathologists identify pre-cancerous lesions and cancer cells in women.
15737295|NCT04965831|Drug|Furmonertinib|Furmonertinib 80mg/d as neoadjuvant therapy for 8 weeks before surgery, then as adjuvant therapy for 3 years after surgery.
15737296|NCT04965818|Drug|Futibatinib and Binimetinib|Patients will receive futibatinib once daily in combination with binimetinib twice daily by oral administration on a 21-day cycle
15737297|NCT04965805|Device|cold plasmaJet kINPen Med|experimental, non-inferiority
15737298|NCT04965805|Device|Best practice wound dressings|comparative,
15737299|NCT04965792|Other|Screening|Blood test
15737300|NCT04965779|Device|Abdominal Binder|Women in the intervention group use an abdominal binder from postpartum hour 1 to 48, and will be checked every 6 hours. The abdominal circumference of the women is measured at the anterior superior iliac spine and umbilicus level with a tape measure before the application, and the binder size is adjusted to be 5% smaller (approximately 0.5-1 cm) than the measurement obtained.
15737301|NCT04965779|Other|Postpartum nursing care|Postpartum nursing care the follow-up protocol includes the evaluation and record between postpartum 1. and 48. hours of pain level, analgesic administration, follow-up of the puerperal bleeding, and uterine tone, measure of hemodynamic parameters measuring, hemoglobin level and hematocrit ratio, and assessment breastfeeding.
15737302|NCT04965766|Drug|U3-1402|First infusion for 90 minutes and then infusion duration can be decreased to 30 minutes if participant didn't experience infusion related reactions (IRR)
15737303|NCT04965753|Drug|FHD-609|FHD-609 as a single, intravenously administered agent given biweekly
15737304|NCT04965740|Drug|Cannabis|Recreational Cannabis
15737306|NCT04965714|Biological|Nivolumab|Given IV
15737307|NCT04965714|Biological|Pegargiminase|Given IM
15737308|NCT04965714|Procedure|Resection|Undergo surgical resection
15737309|NCT04965701|Drug|Osimertinib 80 MG|Osimertinib is administered according to clinical practice at the recommended dose of 80 mg, orally, once a day.
15737310|NCT04965688|Drug|Drug determined by treating oncologist based on recommendation from systems biology analysis.|All patients will have a biopsy at the beginning of the trial. The biopsy will be sent for DNA sequencing through FoundationOne(clinical test) and RNA profiling at Fulgent(research test) for determination of activation of various oncogenic pathways and phenotypes. The results will be analyzed and a treatment recommendation will be made to the treating physician based on an algorithm.
15737313|NCT04965662|Drug|Maraviroc|Maraviroc 300 mg, TWO tablets once daily.
15737314|NCT04965662|Drug|Truvada|Truvada one tablet once daily
15737315|NCT04965649|Genetic|Phenotyping of total and innate CD8+T cells by flow cytometry|"Blood samples from patients in the active file of the Clinical Cytology and Cytogenetics Laboratory at Nîmes University Hospital will be analyzed (diagnosis already known). Samples will be representative of the different stages of the pathology.
~For patients with a confirmed diagnosis of Chronic Myeloid Leukemia and Philadelphia+ Acute Lymphoblastic Leukemia), the remaining whole blood sample taken as part of the usual management will be sent for phenotyping of CD8+ TL (total and innate) by flow cytometry. Phenotyping will be performed on samples pooled at the end of the recruitment period."
15737316|NCT04965636|Drug|Mepolizumab|Mepolizumab will be provided in pre-filled safety syringe
15737317|NCT04965623|Device|Atrial Shunt|Transcatheter treatment of symptomatic left heart failure patients
15737318|NCT04965610|Other|Preoxygenation with High Flow Nasal Cannula|Preoxygenation for 5 minutes via High Flow Nasal Cannula. After induction of anaesthesia apnoeic oxygenation with HFNC
15737319|NCT04965610|Other|Preoxygenation via face mask|Preoxygenation for 5 minutes via face mask. After induction of anaesthesia apnoeic oxygenation with tight fitting face mask
15737320|NCT04965597|Drug|Treosulfan|Given IV
15737321|NCT04965597|Drug|Fludarabine|Given IV
15737322|NCT04965597|Drug|Tacrolimus|Given IV
15737323|NCT04965597|Drug|Methotrexate|Given IV
15737324|NCT04965597|Biological|Thymoglobulin (Rabbit Anti-thymocyte Globulin; rATG)|Given IV
15737325|NCT04965571|Genetic|genetic test|Sanger sequencing and multiplex ligation-dependent probe amplification (MLPA)
15737326|NCT04965558|Other|No intervention|No intervention
15737327|NCT04965545|Dietary Supplement|low copper diet|All patients with wilson disease should receive low copper diet
15737328|NCT04965532|Drug|sevoflurane anesthesia|Sevoflurane enhances the effects of rocuronium and significantly prolongs the duration of action of rocuronium and the time to recovery.
15737329|NCT04965532|Drug|Propofol Injection|Propofol is most commonly used for intravenous anesthesia. In contrast to sevoflurane, propofol has no effects on rocuronium.
15737330|NCT04965519|Drug|RC48-ADC|2.0mg/kg IV every 2 weeks
15737331|NCT04965506|Drug|IBI362|IBI362 administered subcutaneously (SC) once a week.
15737332|NCT04965506|Other|placebo|placebo administered subcutaneously (SC) once a week.
15737333|NCT04965506|Other|Dulaglutide|Dulaglutide administered subcutaneously (SC) once a week.
15737334|NCT04965493|Drug|Pirtobrutinib|Oral
15737335|NCT04965493|Drug|Venetoclax|Oral
15737336|NCT04965493|Drug|Rituximab|Intravenous (IV)
15737337|NCT04965467|Diagnostic Test|Screening for Fabry disease|A questionnaire specifically designed to assess Fabry disease-associated phenotypes in infancy, childhood and adolescence: pain in the hands and feet, angiokeratomas, hypohidrosis, corneal whorls, unexplained renal failure, unexplained hypertrophic myocardiopathy and unexplained early onset stroke. The questionnaire consisted mainly of quantitative, closed questions with pre- defined response options.The diagnosis of FD will be performed by standard procedures following international recommendations. These require the search for a deficiency of alphagalactosidase A activity on leucocytes in males and genetic analysis of the GLA gene in females (Germain et al. 2010). In females plasma Gb3, globotriaosyl- sphingosine (lyso-Gb3) will be measured for screening.
15737338|NCT04965454|Combination Product|Fluorine-18 fluorocholine|18F-fluorocholine is a radiopharmaceutical imaging agent intended for use only with positron emission tomography (PET) imaging. PET with in-line computed tomography imaging of the torso will be performed following intravenous administration of a single unit dose of this investigational new drug.
15737339|NCT04965441|Procedure|Computer-assisted surgery|Preoperative head and neck computed tomography (CT) and lower extremity CT angiography were acquired for all patients. In the CAS group, CT images (slice thickness<1 mm) were imported into a 3D surgical planning software (Proplan, Version 2.0/3.0 Materialise, Leuven, Belgium). Virtual surgical planning was performed to determine the mandibular and fibular resection and cut margins with localization of the optimal angles for performing osteotomies. After that, surgical guides were designed utilizing a 3D designing software (3-Matic, Version 9.0-13.0, Materialise, Leuven, Belgium). The generated virtual templates were exported in Standard Tessellation Language (STL) format and printed with a professional 3D printer (Connex 350, Stratasys, Eden Prairie, MN, USA). The reconstructive plates were pre-bent on a 3D printed planned mandibular model.
15737340|NCT04965428|Behavioral|Fear-focused Self-Compassion Therapy|The Fear-focused Self-Compassion Therapy will be delivered as a group format. The intervention consists of eight group face-to-face sessions (60-90 minute for each session) and will be delivered by three trained therapists for eight weeks (sessions are weekly). Each intervention group involves 10 patients.
15737341|NCT04965415|Behavioral|Health Links + Leadership Training|Help businesses undergo transactional (i.e., business management practices) and transformational (i.e., business leadership and culture) change. Transactional change component: Health Links is an existing community-based intervention that seeks to help businesses - especially small and medium-sized businesses - incorporate Total Worker Health (TWH) programming into their business practices through assessment, advising, and certification. There is evidence that this consultation intervention is effective at helping businesses develop and implement policies and programs.Transformational change component: The experimental arm includes TWH leadership training for small business owners and other senior leaders. This is a three-month training that includes assessments, in-person training, and virtual training transfer activities. The goal is to help the leader understand their organization's current approach to TWH, identify areas for improvement, and to take action.
15737342|NCT04965415|Behavioral|Health Links|Health Links is an existing community-based intervention that seeks to help businesses - especially small and medium-sized businesses - create a culture of both safety and health. Health Links does this by helping businesses incorporate Total Worker Health (TWH) programming into their business practices through assessment, advising, and certification. There is evidence that this consultation intervention is effective at helping businesses develop and implement policies and programs.
15737343|NCT04965402|Drug|BMS-986166|Specified dose on specified days
15737344|NCT04965402|Other|Placebo|Specified dose on specified days
15737345|NCT04965389|Drug|Oral solution|Specified dose on specified days
15737346|NCT04965389|Drug|[14C]BMS-986177 Solution for Infusion|Specified dose on specified days.
15737347|NCT04965389|Drug|BMS-986177 Spray-dried Dispersion Capsules|Specified dose on specified days
15737348|NCT04965376|Procedure|Glenohumeral joint steroid injection|Ultrasound guided steroid injection into the glenohumeral joint (10mls of 1% lidocaine with 40mg depo-medrone)
15737349|NCT04965376|Procedure|Suprascapular nerve block steroid injection|Ultrasound guided steroid injection as a suprascapular nerve block at the spinoglenoid notch adjacent to the nerve as it traverses under the spinoglenoid ligament (10mls of 1% lidocaine with 40mg depo-medrone)
15737350|NCT04965350|Biological|Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Pichia pastoris)|sterile solution for intramuscular injection
15737353|NCT04965324|Other|Anaesthesia Depth|
15737354|NCT04965311|Biological|Botulinum Toxin Type A|Given via endoscopic injection into intraduodenal sphincter of Oddi segment
15737355|NCT04965298|Drug|Lansoprazole|Lansoprazole 30mg (as 2 x 15mg capsules) twice daily, 12 hours apart, for 12 months. IMP should be taken at least 30 minutes before food.
15737356|NCT04965298|Other|Matched placebo|Matched placebo 2 capsules twice daily, 12 hours apart, for 12 months. Treatment should be taken at least 30 minutes before food.
15737357|NCT04965285|Behavioral|quality assesment|"For each time-out procedure observed, the investigators will record compliance for each element of the time-out. Elements that are clearly verbalized by the member of the operating room team performing the time-out were considered compliant.
~As each step of the time-out is verbalized by a team member, the operating room team members are expected to respond. The observations will be conducted by trained study staff using a standardized Checklist/ Proforma to assess surgical team compliance with the time-out protocol and to record general observations of the operating room environment. Any non-routine events that occurred during the time-out process will be recorded.
~In each phase, the Checklist coordinator must be permitted to confirm that the team has completed its tasks before it proceeds onward."
15737362|NCT04965246|Behavioral|Physical Activity|The physical activity program will focus on increasing physical activity, starting with a target of 100 minutes per week. The session durations will build over time to 150 minutes per week. Participants will be instructed to walk, or engage in other forms of light-intensity physical activity to achieve these goals. Participants will be instructed on the use of the ratings of perceived exertion scale (6-20). As the participants' health and fitness status improves, frequency, intensity, and session duration will be modified accordingly during weekly support calls. As participants will enter the study engaging in varying levels of physical activity, goals will be responsive to the most recent week's achieved minutes.
15737363|NCT04965246|Other|Usual Care|Participants in the usual care group will receive no intervention
15737364|NCT04965233|Behavioral|DNA reports|The personalized DNA lifestyle reports cover the following topics: Healthy weight, Vitamin D, Alcohol, Lactose, Injuries, Caffeine, Fitness, Carbohydrates, The mind, Vitamin B, The senses, and Omega.
15737365|NCT04965233|Behavioral|Information reports|Reports containing general information on eczema
15737366|NCT04965220|Drug|HLX 208|take orally
15737367|NCT04965194|Procedure|erector spinae plane block|Superficial probe will be placed 2-3 cm lateral to the spine using a sagittal approach at the level of T8. After identification of erector spinae muscle and transverse processes, the needle will be inserted deeply into the erector spinae muscle. Correct position of the needle tip is confirmed with administration of 0.5-1 ml of local anesthetic (LA), and 20 ml of 0.25% bupivacaine will be administered to perform ESP block. LA spread to both cranial and caudal directions will be seen.
15737368|NCT04965194|Procedure|Quadratus lumborum plane block|"A curved array transducer for the transmuscular QL (TQL) nerve block is placed in the axial plane on the patient's flank just cranial to the iliac crest. The shamrock sign is visualized: The transverse process of vertebra L4 is the stem, whereas the erector spinae posteriorly, QL laterally, and psoas major anteriorly represents the three leaves of the trefoil. The target for injection is the fascial plane between the QL and psoas major muscles. The needle is inserted using an in-plane technique from the posterior end of the transducer through the QL muscle. The injectate (20ml of bupivacaine 0.25%) should ideally spread from the injection site inside the fascial plane between the QL and psoas major muscles to the thoracic paravertebral space with a goal to accomplish segmental somatic and visceral analgesia from T4 to L1."
15737369|NCT04965194|Other|placebo|patients received no regional block
15737370|NCT04965181|Behavioral|Mindfulness-Based Addiction Treatment|Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly virtual 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation.
15737371|NCT04965181|Drug|Nicotine Replacement Therapy|"Patch therapy (beginning quit day) for participants who smoke >10 cigarettes/day will consist of 4 weeks of 21 mg patches, 2 week of 14 mg patches, and 2 week of 7 mg patches. Patch therapy for participants who smoke less than 10 cigarettes/day will consist of 4 weeks of 14 mg patches and 4 weeks of 7 mg patches.
~Lozenge therapy (beginning quit day) for participants who smoke first cigarette within 30 minutes of waking up will consist of 8 weeks of 4mg lozenges. Lozenge therapy (beginning quit day) for participants who smoke first cigarette 30 minutes of more after they wake up will consist of 8 weeks of 2mg lozenges."
15737403|NCT04964947|Drug|Tobramycin Injection|80 milligrams of tobramycin diluted in 40 milliliters of normal saline
15737404|NCT04964947|Drug|Saline|40 milliliters of normal saline
15737372|NCT04965181|Behavioral|Self-help materials|"Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al., 2008) and include the Clearing the Air booklet developed by the National Cancer Institute (NCI) and a referral to the Tobacco Cessation Quitline (1-800-QUIT-NOW)."
15737373|NCT04965181|Behavioral|iQuit Mindfully|iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.
15737375|NCT04965155|Drug|Isatuximab-dexamethasone|Isatuximab 10 mg/kg IV: 1,8,15 and 22 at cycle 1; days 1 and 15 at cycles 2-3 Dexamethasone 40 mg OS: 1,8,15 and 22 at cycle 1; days 1 and 15 at cycles 2-3
15737376|NCT04965142|Behavioral|Exercise Training|The intervention group will be asked to complete aerobic exercises 3 to 5 times per week (≥ 150 minutes of at least moderate aerobic intensity) and resistance training at least twice a week over a 12-week period.
15737377|NCT04965129|Drug|Placebo|Drug: Placebo olive oil pill manufactured to mimic fish oil. Other Names: • Placebo
15737378|NCT04965129|Drug|Fish oil|All subjects will be given fish oil with a dose of of 2.100 mg of EPA and 924 mg of DHA, in four tablet twice daily for four mounths.
15737379|NCT04965116|Drug|Progestin Only Contraceptive Pills|Daily pill (placebo or active tablet)
15737380|NCT04965103|Procedure|SCR|Superior Capsule reconstruction
15737381|NCT04965103|Procedure|Bridging|Tendon repair with graft interposition
15737382|NCT04965090|Drug|Amivantamab|Amivantamab 1050mg IV once weekly for the first 28 days (Cycle 1) and every other week thereafter. For subjects who weigh ≥80 kg, they will receive 350mg IV on C1D1 and 1050 mg on C1D2. They will continue to receive amivantamab 1400 IV once weekly for the first 28 days and every other week thereafter. Each cycle is 28 days in length.
15737383|NCT04965090|Drug|Lazertinib|Lazertinib 240 mg orally once daily and take this continuously, starting C1D1. For patients who weigh <80 kg, on C1D1, patients will receive amivantamab 350 mg IV, with 700 mg given on C1D2.
15737384|NCT04965077|Drug|Recombinant Humanized Monoclonal Antibody MIL97 for Injection|"Dose escalation phase: The patients confirming to the eligibility criteria will be assigned to the 6 dose groups (0.01mg/kg, 0.03mg/kg, 0.1mg/kg, 0.2mg/kg, 0.3mg/kg 0.45mg/kg, respectively) based on the sequence of inclusion. Each patient will receive an intravenous infusion of MIL97 every 3 week on Day 1 of each cycle. Additional 1 or 2 dose cohorts will receive an intravenous infusion of MIL97 every 2 week on Day 1 of each cycle after last patient finishes DLT observation period.
~Dose expansion phase: One or two recommended expansion doses (either Q3W or Q2W) will be selected from 6 dose groups (0.01mg/kg, 0.03mg/kg, 0.1mg/kg, 0.2mg/kg, 0.3mg/kg 0.45mg/kg) based on results of dose escalation phase. MIL97 will be administered via intravenous infusion for 60 to 90 minutes on Day 1 of each cycle."
15737385|NCT04965064|Drug|Capecitabine and Neratinib.|Neratinib 240 mg PO QD Daily On-going Capecitabine 750 mg/m2 PO bid Days 1-14, 7 days off On-going
15737386|NCT04965051|Drug|insulin degludec/insulin aspart (IDegAsp)|To evaluate the efficacy and safety of the IDegAsp in T1DM
15737387|NCT04965051|Drug|basal insulin plus pre-prandial insulin|To evaluate the efficacy and safety of basal insulin plus pre-prandial insulin in T1DM
15737388|NCT04965038|Drug|Alteplase|Intravenous thrombolysis with alteplase within 4.5 hours of symptom onset
15737389|NCT04965025|Procedure|Multi-stage urethroplasty with graft inlay in first stage|Herein, the graft will be used in the first stage and the second stage will solely consist of retubularizing the urethra.
15737390|NCT04965025|Procedure|Multi-stage urethroplasty with graft inlay in second stage|Herein, the graft will be used in the second stage and the first stage will solely consist of opening the urethra longitudinally.
15737391|NCT04965012|Behavioral|Online CBT with MET treatment|The CBT with MET treatment condition will begin with an MET-therapist guided introduction to the program and first module. After this guided introduction, they will have access to the remaining 7 treatment modules and have 6 weeks to complete them. The content of all modules is derived from Cognitive Behavioural Therapy and Motivational Interviewing. Through module engagement, participants will identify goals related to cannabis use, learn strategies to cope with cravings, triggers, and social pressures, and learn to how prevent relapse. Participants will work through modules sequentially.
15737392|NCT04965012|Behavioral|CBT without MET treatment|The CBT without MET treatment condition will begin with a brief non-MET trained research assistant welcome to the program, and will not include working through the first module together. After this welcome, they will have access to the 8 treatment modules and have 6 weeks to complete them. The content of all modules is derived from Cognitive Behavioural Therapy and Motivational Interviewing. Through module engagement, participants will identify goals related to cannabis use, learn strategies to cope with cravings, triggers, and social pressures, and learn to how prevent relapse. Participants will work through modules sequentially.
15737393|NCT04964999|Other|Exercise|Participants will undergo an exercise program during the 2-week bed rest period.
15737394|NCT04964986|Drug|Apraglutide|Apraglutide is a synthetic peptide analogue of GLP-2 under development for treatment of SBS-IF, which acts as a full agonist at the GLP-2 receptor with in vitro potency and selectivity comparable with native GLP-2.
15737395|NCT04964973|Device|Control|Post-surgical physiotherapeutic activity.
15737396|NCT04964973|Device|Experimental|Post-surgical physiotherapeutic activity with the application of the technique
15737397|NCT04964973|Device|Placebo|Post-surgical physiotherapeutic activity with the application of the non-activated technique
15737398|NCT04964960|Drug|Pembrolizumab|Pembrolizumab is an immunotherapy that can help fight certain cancers.
15737399|NCT04964960|Drug|Nab paclitaxel|Nab-paclitaxel is a taxane derivative that is an albumin-bound paclitaxel nanoparticle formulation that promotes microtubule assembly.
15737400|NCT04964960|Drug|Paclitaxel|Paclitaxel is a taxane derivative that promotes microtubule assembly by enhancing the action of tubulin dimers, stabilizing existing microtubules, and inhibiting their disassembly, interfering with the late G2 mitotic phase, and inhibiting cell replication.
15737401|NCT04964960|Drug|Pemetrexed|Pemetrexed is an antifolate agent that disrupts folate-dependent metabolic processes essential for cell replication.
15737402|NCT04964960|Drug|Carboplatin|Carboplatin is a platinum compound alkylating agent which covalently binds to DNA and interferes with the function of DNA by producing interstrand DNA cross-links.
15737414|NCT04964921|Other|Device: ANSiScope Plus|Heart rate variability measurement and vital signs monitoring will be performed on all subjects.
15737416|NCT04964882|Diagnostic Test|ultrasound examination of air insufflation in the upper esophageal region and stomach|Presence of air insufflation is assessed using ultrasound in the upper esophageal region and stomach during face mask ventilation
15737417|NCT04964869|Procedure|epinephrine solution injection|epinephrine solution injection at least 1 ml to the post- sphincterotomy wound
15737418|NCT04964856|Behavioral|ERAS exercise|Take ERAS exercise twice a day from hospitalization to 30 days after surgery
15737419|NCT04964856|Behavioral|No ERAS exercise|Don't take ERAS exercise in perioperative period
15737422|NCT04964830|Device|Orthodontic treatment with functional appliance (MAD)|Expansion plate and z-activator (MAD)
15737423|NCT04964804|Procedure|real-time ultrasound-CT fusion imaging|selective lumbar nerve root block puncture under real-time ultrasound-CT fusion imaging
15737424|NCT04964804|Procedure|ultrasound alone|selective lumbar nerve root block puncture under the guidance of ultrasound alone
15737425|NCT04964778|Device|SKED©|A SKED device is lightweight plastic stretcher used for moving patients through difficult terrain.
15737428|NCT04964752|Device|continuous glucose-monitoring|Continuous glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients with diabetes.
15737429|NCT04964739|Behavioral|Cognitive Behavioral Therapy (CBT4CBT)|Participants will receive one therapist-led motivational interviewing/goal setting session followed by 7 sessions of computerized CBT4CBT.
15737430|NCT04964726|Behavioral|Real-time fMRI dyadic neurofeedback|Participants will attempt to regulate their partner's brain activation in a specified brain region via real-time fMRI neurofeedback.
15737431|NCT04964700|Drug|Natalizumab|Monthly Infusions
15737432|NCT04964687|Procedure|Liver transplantation|Liver transplantation
15737433|NCT04964674|Behavioral|Behavioral Measurement|Take measurements of behavioral performance
15737434|NCT04964661|Other|Medical Imaging|MRI imaging
15737435|NCT04964648|Device|shear wave elastography|Shear wave elastography (SW-EG), a form of ultrasound elastography used in transabdominal ultrasonography, can measure tissue elasticity by generating shear waves inside the organ using the acoustic radiation force impulse (ARFI) The ultrasound machine monitors shear wave propagation and measures the velocity. The shear wave velocity, displayed in kilopascals (kPa) or meters per second
15737436|NCT04964635|Device|TetraGrip II system|"This main aim of this whole research project is to evaluate the performance of the TetraGrip II system in improving the upper limb functions in people with C4-C7 tetraplegia i.e. people who have damaged their spinal cord in the neck resulting in loss of function in all four limbs. The Tetragrip system uses a technique called Functional Electrical Stimulation (FES) in which small electrical impulses are used to activate paralysed muscles and hence provide movement. The stimulation is controlled by sensors which measure the movement of the other shoulder and enable the person to regain the use of their hand via stimulating electrodes placed on the skin over the relevant muscles.
~The feasibility of using this FES based system in restoring the upper arm functions will be evaluated by clinically trying the device on participants with C4-C7 tetraplegia."
15737437|NCT04964622|Drug|Advil|tablet
15737438|NCT04964596|Diagnostic Test|colonoscopy|colonoscopy
15737439|NCT04964596|Diagnostic Test|FIT test|faecal immunochemical test
15737440|NCT04964596|Diagnostic Test|CT colonography|noninvasive medical imaging technique that uses computed tomography to visualize the interior of the colon and rectum especially to screen for polyps or cancerous growths
15737441|NCT04964583|Drug|Hydroxychloroquine with Azithromycin|Fixed combination of Hydroxychloroquine with Azithromycin 200 mg / 250 mg one tablet every 12 hours for five days and continue with Hydroxychloroquine 200 mg one tablet every 12 hours for 5 more days.
15737442|NCT04964570|Behavioral|Video _ behavioral change module|"A short video (primary outcome) that aimed at reducing stigma towards treatments and increasing help seeking intentions.
~The behavioral change module (secondary outcome) is aimed at changing behaviors of sleep, exercise and social support."
15737446|NCT04964531|Other|speckle tracking echocardiography|before and after closure of the PDA , echocardiographic loops of the apical 4, 3 , and 2 chamber will be acquired then processed by special software for measuring the speckle movements in the longitudinal and short axis views
15737447|NCT04964518|Drug|APG 2575 ramp up arm|APG2575 ramp up + Azacitidine
15737448|NCT04964505|Drug|Azacitidine|Given IV or SC
15737449|NCT04964505|Drug|Uproleselan|Given IV
15737450|NCT04964505|Drug|Venetoclax|Given PO
15737451|NCT04964479|Drug|TQB2450 injection|1200mg injection once every 3 week
15737452|NCT04964479|Drug|Anlotinib Hydrochloride Capsules|12mg capsule once daily
15737453|NCT04964479|Drug|Pembrolizumab injection|200mg injection once every 3 week
15737454|NCT04964479|Drug|Placebo|Placebo capsule once daily
15737455|NCT04964466|Biological|Amount of PDGF-BB in PRF preparation vs. GEM21|The quantification will be performed at 60 minutes, 8 hours, 1 day, 3 days, and 10 days. The samples will each be placed in a cell incubator at 37°C to allow for growth factor release into a phosphate-buffered saline. At each desired time point assessment, 2 ml of the sample will be collected, frozen, and replaced with 2 ml of additional phosphate-buffered saline. The protein quantification will be carried out using ELISA assay according to manufacturer's protocol.
15737456|NCT04964466|Biological|Amount of PDGF-BB available in PRF + bone substitutes vs. rhPDGF-BB+ bone substitutes following preparation|Growth factor release assessments will be made to determine the PDGF-BB present in the six prepared samples of the following: 1) PRF + mineralized freeze-dried corticocancellous allograft, 2) PRF + xenograft, and 3) PRF + B-TCP. Assessments will also be made for one sample of each of the following: 1) rhPDGF-BB + freeze-dried bone allograft, 2) rhPDGF-BB + xenograft, and 3) rhPDGF-BB+ B-TCP preparation. This assessment will be made at 60 minutes following the incorporation of the bone graft materials. During this time period, the samples will each be placed in a cell incubator at 37°C to allow for growth factor release into a phosphate-buffered saline. At 60 minutes after preparation, 2 ml of the sample will be collected, frozen, and replaced with 2 ml of additional phosphate-buffered saline. The protein quantification will be carried out using ELISA assay according to manufacturer's protocol.
15737457|NCT04964466|Biological|Release kinetics of PDGF-BB in PRF + bone substitutes vs. rhPDGF-BB + bone substitutes|The release kinetics of PDGF-BB will be assessed for six preparations of each of following: 1) PRF+ mineralized freeze-dried corticocancellous allograft, 2) PRF + bone xenograft, and 3) PRF + B-TCP. The release kinetics of PDGF-BB will also be assessed for one preparations of each of following: 1) rhPDGF-BB + mineralized freeze-dried corticocancellous allograft, 2) rhPDGF-BB + bone xenograft, 3) rhPDGF-BB + TCP. The quantification will be performed at 60 minutes, 8 hours, 1 day, 3 days, and 10 days. The samples will each be placed in a cell incubator at 37°C to allow for growth factor release into a phosphate-buffered saline. At each desired time point assessment, 2 ml of the sample will be collected, frozen, and replaced with 2 ml of additional phosphate-buffered saline. The protein quantification will be carried out using ELISA assay according to manufacturer's protocol.
15737458|NCT04964466|Biological|Release kinetics of PDGF-BB in rhPDGF-BB + PRF + bone substitutes|The quantification will be performed at 60 minutes, 8 hours, 1 day, 3 days, and 10 days. The samples will each be placed in a cell incubator at 37°C to allow for growth factor release into a phosphate-buffered saline. At each desired time point assessment, 2 ml of the sample will be collected, frozen, and replaced with 2 ml of additional phosphate-buffered saline. The protein quantification will be carried out using ELISA assay according to manufacturer's protocol. The samples will each be placed in a cell incubator at 37°C to allow for growth factor release into a phosphate-buffered saline. At each desired time point assessment, 2 ml of the sample will be collected, frozen, and replaced with 2 ml of additional phosphate-buffered saline. The protein quantification will be carried out using ELISA assay according to manufacturer's protocol.
15737459|NCT04964453|Drug|BI 474121|BI 474121
15737460|NCT04964453|Drug|Placebo|Placebo matching BI 474121
15737461|NCT04964440|Device|Pure-EP|Advanced Signal Acquisition and Processing
15737462|NCT04964427|Drug|Methylphenidate|A single dose of 5-10 mg of immediate release MPH (Ritalin®) will be administered in line with NICE and AIFA (Agenzia Italiana del Farmaco) guidelines for ADHD treatment.
15737463|NCT04964427|Device|anodal tDCS|Anodal electrode will be positioned over the left dlPFC, according to the 10-20 EEG on the sites corresponding F3, whereas the reference electrode will be placed above the contralateral supraorbital area, corresponding to Fp2. In the active tDCS condition, the current will increase slowly during the first 30 seconds to 1 mA (ramp-up) and, at the end of the stimulation, the current will decrease slowly to 0 mA during the last 30 seconds (ramp-down). Between the ramp-up and ramp-down constant current will be delivered for 20 minutes, with a density of 0.04 mA/cm2.
15737464|NCT04964427|Device|sham tDCS|In the sham tDCS condition, the stimulation will be delivered by using the same active tDCS montage, respectively left-anodal dlPFC and right-reference electrode over Fp2. Stimulation intensity will be set at 1 mA, but the current will be applied for 30 seconds and will be ramped down without the participants' awareness.
15737465|NCT04964414|Other|Smell Retraining|Smell practice with household scented items
15737466|NCT04964414|Drug|Budesonide|Nasal irrigation with liquid steroid
15737467|NCT04964401|Procedure|Thoracic paravertebral block vs Erector spinae plane block|Thoracic paravertebral block and erector spinae plane block will be performed unilaterally, under US guidance, before the surgical operation, after the induction of anesthesia, when the patient is placed in the lateral decubitus position.
15737468|NCT04964388|Drug|GLP-1 receptor agonist|Diabetes medication
15737469|NCT04964375|Drug|ABSK043 oral capsule|ABSK043 is a novel, oral small molecule inhibitor of PD-L1
15753908|NCT04826978|Behavioral|Auditory environment|Auditory environment
15737471|NCT04964336|Other|Analysis of B cells|B cells from blood and cerebrospinal fluid will be analyzed using RNA-seq
15737472|NCT04964310|Genetic|genetic polymorphism|Observe the genetic polymorphism frequency difference between case and control groups
15737473|NCT04964297|Device|Obtaining bowel gas samples|"The Perf-AlertTM prototype consists of a 15 x 13 x 7 unit containing gas sensors and valves, a small box containing a one-way, ultra-low pressure pump, user controls (buttons), and software algorithms, which control the operation of the device. It is used in conjunction with a single-use, disposable kit of sterile tubing and filters used for sample collection. The sensing unit will be connected via a sterile tube/filter set to any trocar port in use during the procedure. At specific time points during surgery, a one-way valve will be opened, and the unit's pump turned on and withdrawing a small amount of gas from the abdominal cavity. The system is configured that sample collection, transport, analysis, and feedback occur in a single step such that sample collection and sensor feedback occur in real-time. A standard laptop running an analytical software program is connected to the unit to record and log sensor readings."
15737474|NCT04964284|Biological|rhTSH|rhTSH (0.9 mg) was administered intramuscularly (IM) once daily (qd) for 2 days. Twenty-four hours following the second dose of rhTSH
15737475|NCT04964284|Radiation|Radioiodine (131I)|Patients were given an ablative dose of 131I (30 mCi±1.5 mCi).
15737476|NCT04964258|Drug|TAK-105|TAK-105 subcutaneous solution.
15737477|NCT04964258|Drug|TAK-105 Placebo|TAK-105 placebo-matching solution.
15737478|NCT04964245|Device|accelometer|the respiration parameters are measured using an accelometer.
15737479|NCT04964245|Device|thermographic camera|the respiration parameters are measured using an thermographic camera.
15737480|NCT04964245|Device|Electrical Impedance Tomography|the respiration parameters are measured using an electrical impedance tomograhy.
15737481|NCT04964245|Device|Mattress Sensor|the respiration parameters are measured using an Mattress pressure
15737482|NCT04964232|Device|Infrared Camera|The core-temperature is simultaneously measured by esophageal body temperature measurement methods, skin surface body temperature measurement methods, and thermal imaging camera.
15737483|NCT04964232|Device|Esophageal Temperature Probe|In patients undergoing general anesthesia, the Esophageal temeperature parameters are measured using an Esophageal probe.
15737484|NCT04964232|Device|Skin temperature probe|In patients undergoing general anesthesia, the skin spot temeperature parameters are measured using an skin adhesive probe.
15737485|NCT04964219|Drug|S-ketamine|"After anesthesia induction, a bolus of 0.15 mg/kg S-ketamine is injected intravenously about 30 min before incision; this is followed by a continuous infusion at a rate of 0.15 mg/kg/h until 1 hour before the end of surgery.
~After surgery, patient-controlled analgesia is provided. The pump is established with S-ketamine 25 mg, dexmedetomidine 100 microgram, and sufentanil 100 microgram, diluted with normal saline to 100 ml. The pump is programmed to deliver 2-ml boluses with a background infusion rate at 1 ml /h and a 10-min lockout interval."
15737486|NCT04964219|Drug|Placebo|"After anesthesia induction, a bolus of placebo (normal saline) in the same volume is injected intravenously about 30 min before incision; this is followed by a continuous infusion of placebo at the same rate until 1 hour before the end of surgery.
~After surgery, patient-controlled analgesia is provided. The pump is established with placebo, dexmedetomidine 100 microgram and sufentanil 100 microgram, diluted with normal saline to 100 ml. The pump is programmed to deliver 2-ml boluses with a background infusion rate at 1 ml /h and a 10-min lockout interval."
15737487|NCT04964206|Procedure|Neuraxial labor analgesia|Epidural or combined spinal-epidural labor analgesia will be performed according to the routine practice of each study center.
15737488|NCT04964206|Procedure|No neuraxial labor analgesia|Neuraxial analgesia will not be performed. Analgesics will be prescribed by the obstetricians according to routine practice.
15737489|NCT04964193|Drug|Elzsa film-coated tablet|Administered with 240 mL of water
15737490|NCT04964193|Drug|Diane-35 Sugar-coated tablet|Administered with 240 mL of water
15737491|NCT04964180|Drug|Indomethacin suppository|two 100 mg indomethacin rectal suppositories 2 hours prior to surgery
15737492|NCT04964180|Drug|Lidocaine 2% Injectable Solution|200 ml saline containing 200 mg 2%lidocaine intraperitoneal insilltation
15737493|NCT04964167|Combination Product|Plant extract|Natural plant extract
15737494|NCT04964154|Behavioral|Protect Your Elders Campaign|This is a behavioral intervention where participants will receive cultural appropriate educational information about COVID-19 testing and vaccination.
15737495|NCT04964128|Device|MiniMed™ 780G insulin pump with Klue Health app utilizing meal gesture micro insulin dosing (meal gesture dosing)|The AHCL system with Meal Gesture Dosing evaluated in this study includes a commercial/CE-Marked insulin pump with investigational software, and the Klue Health mobile app with investigational software (installed on Apple Watch) for meal gesture detection and micro dosing.
15737496|NCT04964115|Other|Cohort study|This cohort study does not involve an intervention
15737497|NCT04964102|Behavioral|Workshop of Enhancing Interpersonal Effectiveness, Emotional Regulation and Clinical Communication Skills|Workshop of Enhancing Interpersonal Effectiveness, Emotional Regulation and Clinical Communication Skills
15737498|NCT04964089|Drug|KSI-301|Intravitreal Injection
15737499|NCT04964089|Drug|Aflibercept|Intravitreal Injection
15737500|NCT04964089|Other|Sham Procedure|The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
15737501|NCT04964076|Other|No intervention|No intervention
15737502|NCT04964063|Other|Potassium Nitrate + Sodium Fluoride|Potassium Nitrate 5% weight/weight (w/w) and Sodium Fluoride 0.15% weight/volume (w/v) fluoride ion.
15737505|NCT04964037|Other|No intervention|No intervention
15737506|NCT04964024|Diagnostic Test|SARS-CoV-2 antibodies|Analysis of the results of the serological response to COVID-19 and/or Vaccine
15737507|NCT04964011|Other|Board game intervention|In this study, the two groups, the Board game group (12-week board game intervention) and Health promotion group (12-week general health promotion intervention).
15754734|NCT04819906|Drug|Placebo|Five placebo tablets orally once
15737508|NCT04963998|Device|Application of Wound Dressings with Copper Oxide|Application of Wound Dressings with Copper Oxide on chronic foot wounds in diabetic patients
15737509|NCT04963985|Drug|Tafamidis Pill|Oral
15737510|NCT04963972|Behavioral|Behavioral Intervention|Participate in Lucid Lane therapy program
15737511|NCT04963972|Other|Best Practice|Receive standard of care opioid education
15737512|NCT04963972|Other|Questionnaire Administration|Ancillary studies
15737513|NCT04963959|Device|Peripheral blood mononuclear cell apheresis|mononuclear cell donation for tumor immunotherapy study of UCAR-T cells
15737514|NCT04963946|Drug|Stop ACA|discontinuation of acalabrutinib after 18 months in treatment-naïve CLL patients
15737515|NCT04963946|Drug|ACA Continuation|continuation of acalabrutinib at the same dose
15737516|NCT04963933|Device|Nautilus endovascular device|Patients will be treated with the Nautilus Endovascular device followed by treatment follow up for up to 6 months
15737517|NCT04963920|Device|Cytosorb® 300 ml|patients wiil receive CytoSorb therapy in addition to standard of care therapy according to applicable guidelines
15737518|NCT04963907|Device|Active Alpha-Stim CES|Active Alpha-Stim devices will be randomly assigned to participants for use daily for 8 weeks.
15737519|NCT04963907|Device|Sham Alpha-Stim CES|Sham Alpha-Stim devices will be randomly assigned to participants for use daily for 8 weeks.
15737520|NCT04963894|Other|Home functional balance physiotherapy|Experimental physiotherapy program is carried out at home to improve the balance of people with Parkinson's disease through exercises that simulate everyday functional contexts.
15737521|NCT04963894|Other|Conventional physiotherapy|Conventional control physiotherapy program is carried out face-to-face in a rehabilitation gym and in groups of 6 people. The conventional program of physiotherapy includes conventional therapeutic goals of rehabilitation in people with Parkinson's disease.
15737522|NCT04963881|Diagnostic Test|Antibody testing|Blood samples were taken and analyzed for APS antibodies
15737523|NCT04963868|Procedure|Stent removed by the novel strategy|The stent was removed during the last necrosectomy when the endpoint of necrosectomy was achieved；
15737524|NCT04963868|Procedure|Stent removed by the conventional strategy|The stent was removed after the last necrosectomy when clinical symptoms were relieved and fluid was nearly completely resolved confirmed by CT image.
15737525|NCT04963855|Drug|GT300|SIngle oral dose
15737526|NCT04963855|Drug|Microcrystalline cellulose|placebo
15737527|NCT04963842|Behavioral|Use of bio-plastic food packaging material and avoidance of plastic food packaging material|The bio-plastic food packaging material will be used by the study participants for 5 days and no plastic packaged food will be consumed.
15737528|NCT04963829|Biological|gel combined with lemongrass (Cymbopogon citratus) oil at 0.1% concentration|It is a gel that was used in chronic ulcers healing
15737529|NCT04963829|Biological|Collagenase ointment|Participants who were subjected to a standardized treatment (collagenase ointment)
15737530|NCT04963829|Biological|Gel with 10% peel powder of unripe banana|Participants who used a gel made of 10% peel powder of unripe banana (M. sapientum),
15737531|NCT04963816|Procedure|ultrasound guided quadratus lumborum block|Ultrasound guided quadratus lumborum block will be done to all groups using curved array transducer 5_2 MHz with the patient in supine position and the block will be done by anterior approach
15737532|NCT04963816|Drug|Dexamethasone Phosphate 4 MG/ML Injectable Solution intravenously|Using dexamethasone as an adjuvant to bupivacaine in ultrasound guided quadratus lumborum block which will be given intravenously in group A
15737533|NCT04963816|Drug|Bupivacaine Injection|Bupivacaine will be given to all groups locally with QLB
15737534|NCT04963816|Drug|Dexamethasone Phosphate 4 MG/ML Injectable Solution locally|Using dexamethasone as an adjuvant to bupivacaine in ultrasound guided quadratus lumborum block which will be given locally in Group B
15737535|NCT04963803|Device|Active transcranial direct current stimulation (tDCS)|Active transcranial direct current stimulation will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 20 minutes/session for 10 sessions.
15737536|NCT04963803|Device|Sham transcranial direct current stimulation (tDCS)|Sham transcranial direct current stimulation will be delivered using a Soterix mini-CT device. Participants receiving this treatment will be administered 2 milliamperes (mA) of current for 1 minute to simulate the experience of tDCS, after which the current will be ramped down to zero for the remaining 19 minutes of the session. Participants in this arm will receive sham stimulation for 10 sessions.
15737537|NCT04963803|Behavioral|Language Specific Attention Treatment|This is a specific type of speech-language therapy that focuses on simultaneously improving auditory comprehension and behavioral attention. All study participants will receive 10 sessions of this treatment.
15737538|NCT04963790|Behavioral|Tailored COVID-19 vaccine messages|Survey responses from participants will be aggregated to create hesitant patient segments. Then, specific content messages will be created following the health belief model, in a way that is meaningful to the recipients in the different segments, to persuade them to receive the COVID-19 vaccine.
15737539|NCT04963790|Other|Other health messages|Other health messages unrelated to COVID-19 will be sent to participants in the control arm
15737540|NCT04963777|Dietary Supplement|Prebiotic|Chicory root derived inulin-type fructan (8 g/day for ages 8-13 years; 16 g/day for ages ≥14 years)
15737541|NCT04963777|Dietary Supplement|Placebo|Maltodextrin (isocaloric; 3.3 g/day for ages 8-13 years; 6.6 g/day for ≥14 years)
15737542|NCT04963764|Drug|Amoxicillin|Participants will be randomized to receive oral amoxicillin for a standard course (10 days)
15737543|NCT04963764|Drug|Placebo|Participants will be randomized to receive oral placebo for a standard course (10 days)
15737548|NCT04963712|Drug|Zadaxin|1.6 mg subcutaneous injection, once a day in the first 2 weeks, and 1.6 mg subcutaneous injection, twice a week in the second 22 weeks.
15737549|NCT04963673|Other|calcineurin inhibitor dosage|The dosage of calcineurin inhibitors will be done as usual by the toxicology pharmacology laboratory of the CHU Amiens-Picardie. If the patient does not object, the determination of protein-bound uremic toxins from the rest of the collected blood tube will be performed using high performance liquid chromatography.
15737550|NCT04963647|Diagnostic Test|Adult subjects diagnosed with IS or TIA|From the moment the person decides to participate, the patient will undergo the first 24-hour cycle of monitoring with a high-resolution 12-lead Holter. The following day, the Holter report generated will be analyzed by an expert electrocardiographic. After the removal of the first Holter, the study subject will undergo a second monitoring with a 3-lead Holter device for a duration of 6 days, followed by decontamination of the device and archiving of data The electronic data relating to the monitoring periods with Holter will be analyzed with various high-sensitivity AF detection algorithms in order to identify the outcome of the study.
15737551|NCT04963634|Other|Biobanking|For patients included in BRADYDIAG study, 2 blood samples will be collected at enrollment (for group 1: bradykinin angioedema and for group 2: histamine-mediated angioedema) and at 1 year visit (for group 1 only: bradykinin angioedema).
15737552|NCT04963621|Behavioral|Child-Adolescent Emotion and Stress Intervention Program|Intervention programs include Emotion and Stress Intervention for children with emotional and stress problems
15737553|NCT04963608|Drug|Inetetamab|8mg/kg iv day 1 followed by 6mg/kg iv day 1, cycled every 21 days
15737554|NCT04963595|Drug|Pyrotinib|400 mg once daily
15737555|NCT04963595|Drug|Vinorelbine|Initial dose 70 mg/m2 on days 1 and 8 (capsules) If well tolerated, subsequently 90 mg/m2 on days 1 and 8. Capsules on day 1 to be taken at the hospital, and on day 8 at home.
15737556|NCT04963595|Drug|Inetetamab|8mg/kg iv day 1 followed by 6mg/kg iv day 1, cycled every 21 days
15737557|NCT04963582|Procedure|Acupuncture|LI4 is located on the dorsum of the hand, midway between the 1st and 2nd metacarpal bones, approximately in the middle of the 2nd metacarpal bone on the radial side. Acupuncture is practiced by using 0,25x25mm sized needles. LI4 point is punctured perpendicularly 2cm in the direction of the palm center.
15737558|NCT04963556|Dietary Supplement|Red Bull|Drinking of Red Bull before exercise
15737560|NCT04963530|Procedure|Treatment with monolithic zirconia restorations|Treatment with monolithic zirconia restorations on teeth (single crowns). The sample (75 patients) will be divided into three groups according to the ceramic material used: monolithic zirconia, lithium disilicate and metal ceramic.
15737561|NCT04963530|Procedure|Treatment with lithium disilicate restorations|Treatment with lithium disilicate restorations on teeth (single crowns). The sample (75 patients) will be divided into three groups according to the ceramic material used: monolithic zirconia, lithium disilicate and metal ceramic.
15737562|NCT04963530|Procedure|Treatment with metal ceramic restorations|Treatment with metal ceramic restorations on teeth (single crowns). The sample (75 patients) will be divided into three groups according to the ceramic material used: monolithic zirconia, lithium disilicate and metal ceramic.
15737563|NCT04963530|Procedure|No intervention|No intervention.
15737564|NCT04963517|Behavioral|Exercise therapy|8 weeks personalized, multi-modal exercise with focus on lower extremity
15737565|NCT04963517|Other|Information|"Initial consultation with recommendations for general physical activity
~Brochure with exercise recommendations."
15737566|NCT04963504|Diagnostic Test|Rest-to-exercise|Pulmonary diffusing capacity is assessed at rest and during exercise (70% of VO2max on a bicycle ergometer)
15737567|NCT04963504|Diagnostic Test|Sitting-to-supine|Pulmonary diffusing capacity is assessed in the sitting and supine position
15737568|NCT04963491|Device|Personalized TKA prosthesis|TKA prosthesis that is designed and manufactured according to the patient's knee joint anatomy
15737569|NCT04963491|Device|Zimmer NexGen prostheses|Commercial products used on a large scale
15737570|NCT04963478|Other|exercise|exercise testing
15737571|NCT04963465|Diagnostic Test|Ferning on microscopy|Amniotic fluid ferning will be assessed in the cohort before known rupture of membranes and after known rupture of membranes
15737572|NCT04963452|Other|Dural puncture epidural|Parturients, between 18 and 45 years of age, with cervical dilation less than 5 cm were consented to receive a DPE technique, with a single dural puncture with a 26-gauge spinal needle. After successful placement of the epidural catheter and puncturing the dura; 20 mL of bupivacaine 0.25% was administered through the epidural catheter and a patient-controlled epidural infusion of bupivacaine was initiated.
15737573|NCT04963439|Drug|Macitentan|Macitentan dispersible tablets will be administered orally as per assigned treatment sequence.
15737574|NCT04963426|Behavioral|Behavioral interventions targeting multiple risk behaviors as well as protective factors|Depending on the baseline data and prioritization of actions, behavioral interventions related to the following topics will be implemented: alcohol use, dietary behaviors, drug use, hygiene, mental health, physical activity, protective factors, sexual behaviors, tobacco use, violence and unintentional injury.
15737575|NCT04963426|Other|School-level interventions targeting the school environment and system|Depending on the baseline data and prioritization of actions, and based on the Global Standards for Health Promoting Schools, school-level interventions related to the following will be implemented: school policies and resources, school governance and leadership, school and community partnerships, school curriculum, school social-emotional environment, school physical environment, school health services
15737576|NCT04963413|Biological|Autologous DCs derived from PBMC loaded with RNA encoding the human CMV matrix protein pp65-flLAMP plus GM-CSF|Autologous DCs derived from PBMC loaded with RNA encoding the human CMV matrix protein pp65-flLAMP plus GM-CSF
15737577|NCT04963400|Diagnostic Test|Analysis of hs-cTnT serum concentration at hospitalization|Analysis of the hs-cTnT serum concentration in the blood drawn at the day of hospitalization
15737578|NCT04963400|Diagnostic Test|Analysis of hs-cTnT serum concentration after discharge|Analysis of the hs-cTnT serum concentration in the blood drawn after discharge (60 days after hospitalization)
15737579|NCT04963387|Other|Whole body vibration|Balance and muscle strengthening exercises with whole-body vibration, strengthening exercise included straight leg raise with weights, and balance training including walking heel to toe for 20 steps. In this study frequency of 30Hz (4 weeks), with 0.9 mm vertical displacement was used.
15737580|NCT04963387|Other|Balance and Strengthening exercise|Balance and strengthening exercises includes straight leg raise with weights 10 reps. and tandem walk 20 steps 3 days in week for 4 weeks
15737581|NCT04963374|Other|risk evolution scale|Padua score、Caprini score、Prime score
15737582|NCT04963361|Other|patients were exposed to fear of movement|Patients completed the questionnaires independently
15737583|NCT04963361|Other|patients were not exposed to fear of movement|Patients completed the questionnaires independently
15737584|NCT04963348|Other|convolutional neural networks (CNNs)|CNN architecture named U-Net architecture
15737585|NCT04963335|Behavioral|Exergame Training|The individualized exergames were designed for a pressure sensitive plate connected to a personal computer and a frontal screen. The pressure-sensitive plate allows a precise analysis of the user's movements. This concurrent motor-cognitive training aims to improve motor and cognitive functions in an ecological valid setting. The cognitive functions are triggered by specific stimuli in the game scenarios. The video games are controlled via specific (whole body) movements as steps, weight shifting, jumps, and arm movements. The training focus is mainly on multi-tasking, balance and coordination as well as executive functions and attention. Furthermore, the meaningful games (colorful and appealing visuals) were designed to motivate the players to move. As the exergame will automatically adapt (individual progression) during play time, participants are challenged at their individual motor and cognitive level.
15737586|NCT04963322|Other|extracorporeal membrane oxygenation therapy|Extracorporeal membrane oxygenation for the management of severe refractory heart and lung dysfunction
15737587|NCT04963309|Other|endotracheal tube extubation in the operating room|endotracheal tube extubation in the operating room
15737588|NCT04963296|Drug|Obinutuzumab|Obinutuzumab will be administered by IV infusion at a dose of 1000 mg on Day 1 and Weeks 2, 24 and 26.
15737589|NCT04963296|Drug|Placebo|Placebo matching obinutuzumab will be administered by IV on Day 1 and Weeks 2, 24 and 26.
15737590|NCT04963296|Drug|Acetaminophen/Paracetamol|Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.
15737591|NCT04963296|Drug|Diphenhydramine hydrochloride|Diphenhydramine 50 mg will be administered as premedication prior to infusions.
15737592|NCT04963296|Drug|Methylprednisolone|Methylprednisolone 80 mg IV will be administered as premedication prior to infusions.
15737593|NCT04963283|Drug|Cabozantinib|Cabozantinib is a multi-targeted inhibitor of RTKs. The targets of cabozantinib include several RTKs known to play important roles in tumor cell proliferation and/or tumor neovascularization, namely MET, VEGFR2 (also known as KDR), AXL, and RET. Other recognized targets of cabozantinib include ROS1, TRKA, TRKB, TIE2, TYRO3, and MER, two additional members of the VEGFR family (VEGFR1, VEGFR3), and the closely related RTKs KIT and FLT-3. The mode of action for cabozantinib is similar to other drugs targeting RTKs: binding in a fully reversible manner to a region of the kinase domain (including the ATP-binding site) which forces the kinase activation loop into a pseudo-inactive conformation, thereby inhibiting subsequent catalytic activity.
15737594|NCT04963283|Drug|Nivolumab|Nivolumab is a human monoclonal antibody that targets the programmed death-1 (PD-1) cluster of differentiation 279 (CD279) cell surface membrane receptor. Nivolumab binds specifically to the human PD-1 receptor and inhibits the interaction of PD-1 with its ligands, programmed death ligands-1 (PD-L1) and 2 (PD-L2), which promotes immune responses and antigen-specific T-cell responses to foreign- and self- antigens. Nivolumab is expressed in Chinese hamster ovary (CHO) cells and is produced using standard mammalian cell cultivation and chromatographic purification technologies.
15737595|NCT04963270|Drug|Satralizumab|Satralizumab will be administered as a subcutaneous injection
15737596|NCT04963270|Other|Placebo|Satralizumab placebo will be administered as a subcutaneous injection
15737597|NCT04963257|Drug|sertraline fluvoxamine|the initial dose of sertraline was given 50mg/d and the initial dose of fluvoxamine was 50mg/d, and the target dose of sertraline was gradually increased to 200mg/ d and the target dose of fluvoxamine was 200-300mg/d within 2 weeks, and the specific dose adjustment process was determined by the doctors on the basis of patients' conditions
15737598|NCT04963257|Drug|sertraline|The initial dose of sertraline was 50mg/d and the initial dose of aripiprazole was 5mg/d. The target dose of sertraline was 200mg/ d and the target dose of aripiprazole was 5-20mg/d within 2 weeks, and the specific dose adjustment process was determined by the doctors on the basis of patients' conditions
15737599|NCT04963231|Drug|Setmelanotide|Subcutaneous injection
15737600|NCT04963231|Drug|Placebo|Subcutaneous injection
15737601|NCT04963218|Diagnostic Test|AI Algorithm to detect LVEF in ECG|A clinical decision support software as a medical device that detects whether a patient has LVEF less than or equal to 40% based upon the input of one or more ECG vectors at the point-of-care.
15737602|NCT04963205|Device|Adjustable bed backrest|The adjustable bed backrest facilitates for the individual high lying with a fowler (90 degrees raised head and trunk) and/or semi fowler position (30-45 degrees raised head and trunk) which enables patient's lung expansion. The diaphragm is pulled downwards by the gravity allowing for lung expansion and improved ventilation. In addition, the upper airways are stretched in order to prevent upper airway narrowing during sleep (flow limitation, snoring, obstructive sleep apnea). The position relaxes the tension of the abdominal muscles, allowing for improved breathing. Patients can define their own most comfortable position during the night. Elevated body position over 30 degrees from supine position is a requirement for the intervention group. No sleeping time restrictions will be applied. One week washout period between the interventions will be used.
15737603|NCT04963205|Other|Standard bed|Sleeping in a standard bed, in a position below 30 degrees from supine position. No sleeping time restrictions will be applied. One week washout period between the interventions will be used.
15737604|NCT04963192|Device|Connected actimeter to measure physical activity in OSA patients|Connected actimeter worn for one week before initiation of treatment, at M3 and at M6, to measure average daily steps for OSA patients
15737605|NCT04963192|Device|Connected BORA Band to measure physical activity in COPD patients only|Connected BORA Band worn for one week before initiation of treatment, at M3 and at M6, to measure average daily steps for COPD patients only
15737895|NCT04960696|Diagnostic Test|OSDI|Change of OSDI in distance education
15737606|NCT04963192|Other|IPAQ to evaluated physical activity|Physical activity evaluated by IPAQ (International Physical Activity Questionnaire) at the inclusion, M3 and M6
15737607|NCT04963192|Device|Connected scale to measure weight|Weight measured by a connected scale, before CPAP or NIV treatment, at M3 and M6
15737608|NCT04963192|Device|Connected tensiometer to measure arterial pressure|Arterial pressure measured by a connected tensiometer, before CPAP or NIV treatment, at M3 and M6
15737609|NCT04963192|Device|Connected BORA Band to measure oxygen saturation in COPD patients only|Daily oxygen saturation measured by the connected BORA Band for COPD patients only during 6 months
15737610|NCT04963192|Device|Connected BORA Band to measure heart rate in COPD patients only|Daily heart rate measured by the connected BORA Band for COPD patients only during 6 months
15737611|NCT04963192|Device|Connected BORA Band to measure respiratory rate in COPD patients only|Daily respiratory rate measured by the connected BORA Band for COPD patients only during 6 months
15737612|NCT04963192|Other|EXASCORE to evaluated COPD severity|COPD severity evaluated by the EXASCORE questionnaire at inclusion, M3 and M6 for COPD patients only
15737613|NCT04963192|Other|Epworth scale to evaluate sleepiness|Sleepiness evaluated by the Epworth scale at baseline, M3 and M6
15737614|NCT04963192|Other|Pichot scale to evaluate fatigue|Fatigue evaluated by the Pichot scale at inclusion, M3 and M6
15737615|NCT04963192|Other|Usability questionnaire|Subjective assessment of each device by means of usability questionnaire at M6
15737616|NCT04963192|Other|SF36 questionnaire|Quality of life evaluated by the SF36 questionnaire at inclusion and M6
15737617|NCT04963179|Device|Womed Leaf|"Womed Leaf™ device is composed of a uterine anti-adhesion film pre-loaded inside a flexible inserter.
~Womed Leaf™ is inserted in the uterine cavity by the gynecologist surgeon as a film folded into a 5 mm diameter flexible inserter. Once released, the film will unfold and swell into the uterine cavity to keep uterus walls separated during approximately 5 days. It is degraded and discharged naturally through the cervix and vagina in less than 30 days."
15737620|NCT04963140|Other|Optimized self-management of asthma|Short-term increase of asthma medication (as prescribed by the study doctor at enrolment) if an increased risk of asthma exacerbations is detected by the home monitoring device
15737621|NCT04963140|Other|Conventional self-management of asthma|Short-term increase of asthma medication (as prescribed by the study doctor at enrolment) is based on subject's self-perception of symptoms
15737622|NCT04963127|Diagnostic Test|Computed Tomography of the skeleton using a Dual-Energy-/Multi-Energy-/Spectral acquisition mode|CT acquisition using a Dual-Energy / Multi-Energy / Spectral acquisition mode
15737623|NCT04963127|Diagnostic Test|Computed Tomography of the skeleton using a conventional single-energy / non-spectral acquisition mode|CT acquisition using a standard single energy / non-spectral acquisition mode
15737624|NCT04963114|Behavioral|art therapy|guided art tour and workshop
15737625|NCT04963088|Drug|BGB-A317|Subjects will be treated with BGB A317 200 mg IV on Day 1 during each 21-day cycle. BGB A317 will be administered until disease progression, intolerable toxicity, or treatment discontinuation for any other reason
15737626|NCT04963088|Drug|Anlotinib|oral administration daily d1-d14, q3w;
15737627|NCT04963088|Drug|Oxaliplatin|30 mg/m² IV on Day 1 during each 21-day cycle. during each 21-day cycle
15737628|NCT04963088|Drug|Capecitabine|1000 mg/m² orally twice daily (bid) Days 1 through 14 (14 days total) during each 21-day cycle. Capecitabine will be administered until disease progression, intolerable toxicity, or treatment discontinuation for any other reason.
15737629|NCT04963075|Device|multisensory rehabilitation paradigm|"In initial (training) sessions, subjects will be exposed (and respond) to spatiotemporally congruent pairs of visual-auditory stimuli presented within their blinded field, with occasional probes of unisensory visual stimuli on both sides of space. Once recovery of visual responsiveness in the contralesional field is observed, sessions will alternate between training/testing and testing only sessions in which performance on the visual battery will be re-assessed."
15737630|NCT04963062|Device|Holmium laser with Moses lasers|The holmium laser with Moses is FDA approved. It emits two separate laser pulses with a short time interval between them. The first pulse divides the water between the laser fiber tip and the stone and the second pulse hits the stone unobstructed. The goal is to increase stone ablative volume and decrease retropulsion of the stone.
15737631|NCT04963062|Device|Holmium laser with thulium lasers|The holmium laser with thulium laser is FDA approved. It has a different wavelength then the holmium laser with Moses and thus has slightly different energy properties. It has also been shown to increase ablative volume and decrease retropulsion without any safety concerns
15737632|NCT04963049|Other|Protocol with Mask|Look at differences in group with facemask and no mask
15737633|NCT04963036|Other|Entropy and NOL-Guided Goal Directed Anesthesia|Entropy-guided Anesthesia (Propofol infusion in order to maintain Entropy between 45 and 55) and NOL-guided Analgesia (Remifentanil infusion in order to maintain NOL-Index between 10 and 25).
15737634|NCT04963036|Other|Standard of Care Group (Entropy and blinded NOL)|"Entropy-guided Anesthesia (Propofol infusion in order to obtain Entropy between 45 and 55) and Remifentanil infusion at the discretion of the anesthetist in charge, based on current practice: patient vitals (Heart Rate, Blood Pressure, Respiratory Rate…), movements, spontaneous breathing, experience....
~In this group, nociception monitor screen will be concealed and the NOL index will not be available for guidance of remifentanil dosing)."
15737635|NCT04963023|Other|Physical examinations|BPCO physical examinations
15737636|NCT04963023|Diagnostic Test|blood test|blood test in order to study immunologic markers
15737637|NCT04963010|Diagnostic Test|second forward view|second forward view examination of the proximal colon
15737665|NCT04962750|Device|Low level laser therapy|Low level laser therapy from suitable machine
15737666|NCT04962750|Other|Sham device|The device wasn't working
15737722|NCT04962308|Biological|The SARS-CoV-2 Inactivated Vaccine|600SU inactivated virus in 0·5 mL of aluminiumhydroxide solution per injection
15737723|NCT04962295|Other|No intervention|No intervention
15737896|NCT04960696|Diagnostic Test|tear break up time|Change of tear break up time in distance education
15737638|NCT04962997|Other|Data collection|"Investigator will ensure the completion of a hetero-administered questionnaire which will be carried out in French, English, Portuguese or Spanish depending on the language spoken by the participant, including informations related to Demography and socio-economic conditions, Addictions, Work and studies, Housing, Health coverage, Gender and sexuality, Vulnerabilities and violence, Recourse to care, State of physical health, Mental Health, Prevention and Sexually Transmitted Infections (STIs), Checkup, Transition path and clinical complications and Dermatological problems.
~Investigator will collect the data relating to the clinical examination, dermatological examination and the search for STIs (blood and / or urine) carried out in the routine care of the participant in a case report form (CRF).
~The estimated duration of the interviews and the consultation is approximately 1 hour per patient."
15737639|NCT04962984|Procedure|blood sampling|additional blood sampling for coagulation tests
15737640|NCT04962971|Dietary Supplement|Exocyan Cran 40SD|INGREDIENTS PER 1 CAPSULE (414 mg): Exocyan Cran 40SD 404 mg (Vaccinium macrocarpon Aiton, hydroxide magnesium, tricalcium phosphate), stearate. Original capsule vegetable (HPMC)
15737641|NCT04962971|Dietary Supplement|Exocyan Cran 40G|NGREDIENTS PER 1 CAPSULE (383 mg): Exocyan Cran 40G 373 mg (Vaccinium macrocarpon Aiton), stearate. Capsule plant-based (HPMC)
15737642|NCT04962971|Dietary Supplement|Exocyan Cran FG|INGREDIENTS PER 1 CAPSULE (428 mg): Exocyan Cran FG 418 mg (Vaccinium macrocarpon Aiton, hydroxide magnesium, tricalcium phosphate), stearate. Original capsule vegetable (HPMC)
15737643|NCT04962958|Procedure|Hepatic arterial infusion chemotherapy|administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
15737644|NCT04962958|Drug|Folfox Protocol|Oxaliplatin , fluorouracil, and leucovorin
15737645|NCT04962958|Drug|Donafenib|administration of Donafenib
15737646|NCT04962945|Procedure|Oblique-axis approach group|The first two attempts via the oblique-axis approach will be performed . If the first two attempts failed, the subsequent attempts of venipuncture were performed using the long-axis approach.
15737647|NCT04962945|Procedure|Long-axis approach group|The first two attempts via the long-axis approach will be performed . If the first two attempts failed, the subsequent attempts of venipuncture were performed using the oblique-axis approach.
15737648|NCT04962932|Behavioral|Internet-deliviered exposure-based CBT|The intervention lasts for 10 weeks and include: Education, Interoceptive exposure, exposure in-vivo, combining in-vivo exposure with interoceptive exposure, behavioral activation and relapse prevention. Include the guidance of a minimum weekly contact with a CBT psychologist.
15737649|NCT04962932|Behavioral|Internet-delivered stress management treatment|The intervention last for 10 weeks and include: Internet-SMT include life-style advice (e.g., exercise, sleep advice), relaxation and problem-solving skills to reduce stress. Patients are offered regular online contact with a psychologist with the same frequency and intensity as in the CBT arm.
15737650|NCT04962906|Drug|Gam-COVID-Vac / Gam-COVID-Vac|A comparison of antibody levels against protein S will be performed using the Gam-COVID-Vac / Gam-COVID-Vac group as a control group and the Gam-COVID-Vac / ChAdOx1 nCoV-19 and Gam-COVID-Vac / BBIBP-CorV groups as comparators.
15737651|NCT04962893|Biological|SARS-CoV-2 VLP Vaccine-Wuhan|Alum adsorbed, CpG ODN adjuvanted VLP vaccine expressing HexaPro-S, M, N, E proteins of the virus
15737652|NCT04962893|Biological|SARS-CoV-2 VLP Vaccine-Alpha (British) variant|Alum adsorbed, CpG ODN adjuvanted VLP vaccine expressing HexaPro-S, M, N, E proteins of the virus
15737653|NCT04962893|Biological|SARS-CoV-2 VLP Vaccine-Wuhan+Alpha variant|Alum adsorbed, CpG ODN adjuvanted VLP vaccine expressing HexaPro-S, M, N, E proteins of the Wuhan or Alpha variants
15737655|NCT04962841|Other|Nutraceuticals|To observe the effect on cognitive and physical impairment.
15737656|NCT04962828|Other|Vocabulary based intervention- Non Collaborative|List of 10 words functional words Therapy 3 times a week for 20 minutes Duration = 9 weeks Only with SLP
15737657|NCT04962828|Other|Vocabulary based intervention - Collaborative|List of 10 words functional words Therapy 3 times a week for 20 minutes Duration = 9 weeks With SLP and to be reinforced by teachers in class over the week
15737658|NCT04962815|Device|Electroencephalogram (EEG) Test|EEG test and delirium assessments will be performed on subjects experiencing delirium in the ICU.
15737659|NCT04962802|Behavioral|Manhood 2.0|Manhood 2.0 engages young men in questioning, challenging, and transforming harmful gender norms, with the goal of reducing intimate partner and sexual violence and unintended teen pregnancy. Manhood 2.0 is a male-only group-level intervention, based on social cognitive theory, social norm theory, theory of gender and power, and the theory of reasoned action. Activities include group discussion, role playing, knowledge sharing, and skill-building; their purpose is to challenge young men to think critically about social expectations and restrictive norms, engage in dialogue about these gender norms, and then assess the way rigid norms affect their attitudes and behaviors toward key issues, including intimate relationships, gender-based violence, substance abuse, sexually transmitted infections, and early pregnancy. Sessions are two hours long and occur once a week for seven weeks.
15737660|NCT04962802|Behavioral|Post-High School Readiness|Post-High School Readiness program helps young men prepare for life after high school. This includes helping them prepare resumes, learning how to apply to jobs or colleges, providing interview prep, and other life skills. It is a male-only group-level program that includes discussion, feedback, knowledge sharing, and skill-building; their purpose is to prepare young men for life after high school. Sessions are two hours long and occur once a week for seven weeks.
15737661|NCT04962789|Diagnostic Test|transvaginal ultrasound on the uterus|"Transvaginal ultrasound measurement to record endometrial thickness 2 times in each cycle:
~In case of fresh cycles: 1)Day of ovulation triggering 2)Day of embryo transfer In case of frozen thawed cycles : 1)End of estrogen phase 2)Day of embryo transfer"
15737897|NCT04960696|Diagnostic Test|schirmer|Change of schirmer in distance education
15737667|NCT04962737|Device|Non-invasive Neuromodulation|The electrodes will be placed with the help of gloves and adapted socks for 1 hour, twice a week, until 10 intervention sessions are completed. In addition, depending on the session, an adhesive electrode will be placed at the level of C7. Characteristics of microcurrents: pulsed monophasic rectangular wave with a pulse of 1.3 s and pause of 300 ms, voltage 3 mV and intensity 0.5 μA.
15737671|NCT04962711|Other|Heart Failure intervention (Cardio-Oncology Disease Management Plan (CO-DMP)|A clinical review to ensure optimal risk factor control and cardioprotection along with exercise intervention.
15737672|NCT04962711|Other|Usual care|provided by participants' usual healthcare professional(s)
15737673|NCT04962698|Behavioral|Visual motor imagery (MI)|Subjects will relax their muscles and perform conventional visual mental imagery (MI). With the guidance of audio instruction, the subjects will imagine the grasp and release motions with the right arm for 2 s in each motion in their mind. There will be no proximal muscle contraction.
15737674|NCT04962698|Behavioral|Kinesthetic MI|The same MI procedure as Visual MI will be performed, except that the subjects will focus on the kinesthetic sensation that they would feel with the imagined motions.
15737675|NCT04962698|Behavioral|Robotically augmented practice|Subjects will perform robotically augmented mental practice for grasp and release motions with the activation control of the proximal muscles. During this task, subjects will also imagine the kinesthetic sensation that they would feel with the corresponding motions with the right arm.
15737676|NCT04962698|Behavioral|Robotically augmented practice without MI|Subjects will perform the robotically augmented practice without MI.
15737677|NCT04962698|Behavioral|Proximal muscle contraction|Subjects will perform the robotically augmented practice with visual feedback of virtual robot actions on a monitor.
15737678|NCT04962698|Behavioral|Robotic action observation|Subjects will relax their muscles and focus on observing the computer-controlled grasp and release actions of the robotic prosthesis.
15737679|NCT04962698|Behavioral|Rest|Subjects will rest without a task.
15737681|NCT04962672|Drug|Propofol group|20 patients scheduled for the elective craniotomy for suspected high-grade gliomas resection will be enrolled and further randomized to receive total intravenous anesthesia (propofol group). Standard fasting and monitoring guidelines will be instituted. All patients will be induced and intubated after administration of intravenous boluses of fentanyl, propofol and rocuronium. For the maintenance phase of anesthesia, patients in the propofol group will receive continuous infusions of propofol and remifentanil. No patients will receive nitrous oxide. Anesthesia will be titrated to keep depth of anesthesia between 35- 55. All patients will be maintained on oxygen in air mixture (40%) and titrate the End Tidal Carbon Dioxide (ETCO2) concentration between 25-30 mm Hg.
15737682|NCT04962672|Drug|Sevoflurane group|20 patients scheduled for the elective craniotomy for suspected high-grade gliomas resection will be enrolled and further randomized to receive Volatile (sevoflurane group) agent for the maintenance phase of anesthesia. Standard fasting and monitoring guidelines will be instituted. All patients will be induced and intubated after administration of intravenous boluses of fentanyl, propofol and rocuronium. For the maintenance phase of anesthesia, patients in the volatile inhalational anesthesia group received a volatile inhalational agent (sevoflurane) and remifentanil infusion. No patients will receive nitrous oxide. Anesthesia will be titrated to keep depth of anesthesia between 35- 55. All patients will be maintained on oxygen in air mixture (40%) and titrate the End Tidal Carbon Dioxide (ETCO2) concentration between 25-30 mm Hg.
15737683|NCT04962659|Behavioral|Mindfulness-Based Music and Songwriting|The Mindfulness-Based Music and Songwriting (MBMS) program involves up to 8 weekly sessions (~1 hour each) delivered via telehealth. During sessions, the participant works with a therapist (e.g., board-certified music therapist) to learn and apply mindfulness practices via music-based meditations and mindful songwriting. Supported by the therapist, participants write two songs during the program.
15737684|NCT04962646|Procedure|Carbon dioxide flooding|Once the thoracic cavity is opened a flow of carbon dioxide of 5L/min will be initiated into the surgical wound and proceed until there is no connection between the cardiac or aortic cavity and surrounding air.
15737685|NCT04962633|Other|Probiotic Pasta|Subjects will consume for 4 weeks 80 g per day of probiotic durum wheat pasta. All subjects will be requested not to change the other daily dietary habits and their physical activity levels during the 4 week intervention period.
15737686|NCT04962633|Other|Control Pasta|Subjects will consume for 4 weeks 80 g per day of conventional durum wheat pasta without probiotics. All subjects will be requested not to change the other daily dietary habits and their physical activity levels during the 4 week intervention period.
15737687|NCT04962620|Drug|Bovhyaluronidase azoximer|Rectally or vaginally 1 suppository of Longidaze every 2 days. The main course of treatment - 10 suppositories (for 30 days). Then (according to the doctor's decision) supportive therapy is prescribed for 1 suppository 1 time in 7 days. Course of supportive treatment - 17 suppositories for another 120 days. The patients took dienogest according to the instructions for use.
15737721|NCT04962308|Biological|SARS-CoV-2 Inactivated Vaccine|600SU inactivated virus in 0·5 mL of aluminiumhydroxide solution per injection
15738124|NCT04958772|Biological|Granulokine|Granulokine 5 μg/Kg/day, subcutaneous single dose
15737688|NCT04962607|Other|Neo-Putty® as dressing agents in pulpotomized primary molars|"Following removal of the coronal pulp with a round bur and hemostasis, the pulp stumps in the study group will be covered with Neo-Putty ® according to the manufacturer's instructions. Neo-Putty will be placed in the prepared cavity, and then covered with Vitrebond® and with a reinforced Zinc Oxide-Eugenol (IRM, Bayer-Leverkussen, Germany).
~In the control group, a cotton pellet moistened with full-strength FC will be placed for 5 minutes on the amputated pulp, after reaching hemostasis. The pulp stumps will be then covered by IRM"
15737692|NCT04962568|Diagnostic Test|DTEE|endexpiratory diaphragm thickness in mm
15737693|NCT04962568|Diagnostic Test|DTEI|endinspiratory diaphragm thickness in mm
15737694|NCT04962568|Diagnostic Test|DEx|diaphragm excursion during rest and diaphragmatic excursion during maximal inspiration in mm
15737695|NCT04962555|Procedure|Meniscus Suture|Patients with knee joint meniscus injury undergoing meniscus suture
15737696|NCT04962555|Procedure|Partial meniscus resection|Patients with knee joint meniscus injury undergoing partial meniscus resection
15737697|NCT04962555|Procedure|Subtotal meniscus resection|Patients with knee joint meniscus injury undergoing subtotal meniscus resection
15737698|NCT04962555|Procedure|Complete meniscectomy|Patients with knee joint meniscus injury undergoing complete meniscectomy
15737699|NCT04962542|Other|ventilation|low volume positive pressure ventilation is better than continuous positive airway pressure and passive deflation on arterial oxygenation and PPD after CPB in pediatrics undergoing cardiac surgeries for non-cyanotic congenital heart defects.
15737700|NCT04962529|Procedure|Blood Draw|Blood will be drawn from each patient to check the concordance between liquid and tissue biopsy
15737701|NCT04962516|Device|single-use precision filtered infusion sets|single-use precision filter infusion set (Dalian JMS Medical Apparatus Co., Ltd.)
15737702|NCT04962516|Device|single-use precision filter infusion set with needle|single-use precision filter infusion set with needle (Shandong Zhongbao Kang Medical Apparatus Co., Ltd.)
15737703|NCT04962503|Drug|Afamelanotide|Six adult patients with clots located in the higher segments of the brain and who are ineligible for alternative treatments will be enrolled in the study and evaluated for six weeks. The study will assess patients' brain injury with computed tomography (CT) scans and magnetic resonance imaging (MRI), as well as using recognised methods of clinical evaluation to measure changes in patients' neurological and cognitive function following treatment.
15737704|NCT04962490|Procedure|Repair: suture, reinsertion, tendon graft, surgery in two stages (Hunter, Paneva Holevich)|Repair tendon flexor sections in the hand: Suture, reinsertion, tendon graft, surgery in two stages (Hunter, Paneva Holevich). The surgery depends on the anatomical area of the tendon section and the time between the injury and the operation.
15737705|NCT04962477|Other|Nasal brush sampling|Nasal brush samples will be collected from the inferior turbinate using standardized techniques after local anesthetic application. After clearing the mucus from the nasal cavity by asking the patient to blow their nostrils twice followed by local anesthetic spray application, nasal brush samples will be collected from the inferior turbinate of each nostril with dedicated soft cytology brushes and pooled together for molecular biological experiments. Simultaneously, 10 mL of peripheral blood will be collected for immunophenotyping.
15737706|NCT04962464|Dietary Supplement|Peak Human Labs calorie mimetic supplement|Supplement
15737707|NCT04962464|Behavioral|Fasting Mimicking Diet|Diet
15737708|NCT04962451|Drug|ticagrelor + ASA|On day 1, ticagrelor loading dose (2 tablets, ticagrelor 90mg) was given, followed by ticagrelor 90mg, twice daily Basic treatment: the first day received ASA loading dose, 300-325mg, and the server received ASA 75-100mg, once a day
15737709|NCT04962451|Drug|Placebo+ASA|Placebo loading dose on day 1 (2 tablets, matched with ticagrelor 90mg), followed by placebo twice daily (matched with ticagrelor 90mg) Basic treatment: the first day received ASA loading dose, 300-325mg, and the server received ASA 75-100mg, once a day
15737710|NCT04962438|Drug|Anti-VEGF|Anti-tumor drugs targeting the vascular endothelial growth factor (VEGF) signaling pathway
15737711|NCT04962425|Drug|Trastuzumab|Trastuzumab [Herceptin] is a recombinant DNA-humanized monoclonal antibody that selectively targets the HER-2 receptor on the surface of tumor cells.
15737712|NCT04962412|Other|"Standard care bundle"|"The management for AKI patients were performed by implementing a standard care bundle suggested by the Kidney Disease Improving Global Outcome (KDIGO) guideline."
15737713|NCT04962399|Diagnostic Test|Enzyme linked immunosorbent assay|Serum N / OFQ and IL-6 levels were detected，and the genotype and allele frequencies of rs1800796 in IL-6 gene were determined.
15737714|NCT04962386|Drug|Hormone replacement therapy|HRT women were treated with an estrogen-progesterone combination therapy packaged with estradiol tablets/estradiol and dynamic progesterone (Abbott Health Products BV, Weesp, the Netherlands).Take this medicine once a day.A course of treatment was defined as 28 days of continuous treatment.One white tablet containing 1mg of estradiol was taken daily for the first 14 days and one gray tablet containing 1mg of estradiol and 10 mg of dynamic progesterone was taken daily for the remaining 14 days.
15737715|NCT04962373|Other|Semi-structured interviews|Each participant will attend a 30-60 minute semi-structured interview conducted by the CI
15737716|NCT04962360|Dietary Supplement|Nutritional supplementation standardized formula|Powder added to water, containing about 25% of recommended Daily Recommended Intake (DRI) for calories, high protein (25% of calories) and multivitamin and mineral (25%-100% of DRI for recommended daily allowance (RDA) or adequate intake
15737717|NCT04962360|Dietary Supplement|Placebo|Low caloric formula (Powder added to water) without added vitamins and minerals
15737718|NCT04962334|Dietary Supplement|Nutritional supplementation standardized formula.|Powder added to water, containing about 25% of recommended daily recommended intake (DRI) for calories, high protein (25% of calories) and multivitamin and mineral (25%-100% of DRI for recommended daily allowance (RDA) or adequate intake
15737719|NCT04962334|Dietary Supplement|Placebo|Low caloric formula (powder added to water) without added vitamins and minerals
15737724|NCT04962282|Other|Follow-up by telephone|Studies have shown that the compliance of patients at 8-12 weeks reaches a peak, so this time node is the most suitable time node to investigate compliance. Telephone follow-up is irreplaceable convenience, so the telephone follow-up survey of patient compliance with exercise prescriptions is The most feasible method The purpose of the telephone follow-up is to 1. Investigate the compliance of the patients; 2. Make the patients fill out a self-made research compliance scale influencing factors through the telephone.The purpose of the telephone follow-up is to 1. Investigate the compliance of the patients; 2. Make the patients fill out a self-made research compliance scale influencing factors through the telephone.
15737725|NCT04962269|Diagnostic Test|MRI|monoexponential model, intravoxel incoherent motion (IVIM) model and stretched exponential model
15737726|NCT04962256|Procedure|Enhanced recovery after surgery|ERAS management includes 3 parts: (1) Preoperative analgesia and airway evaluation. (2) The protection and reconstruction of the musculo-ligamentous complex during the surgery, the safe intubation, and the local infiltration anesthesia during surgery. (3) Collar free, multimodal analgesia, airway management, and early recovery after surgery.
15737727|NCT04962243|Procedure|Repair surgery for Achilles tendon rupture|Repair surgery for Achilles tendon rupture
15737731|NCT04962217|Other|Semi-structured interviews|Each participant will attend a 30-60 minute semi-structured interview conducted by the CI
15737733|NCT04962191|Diagnostic Test|Idylla EGFR Mutation Test|This diagnostic test is performed on the BioCartis Idylla System for qualitative detection of exon mutations.
15737734|NCT04962178|Procedure|Primary PCI|The patients assigned to early invasive strategy group will receive the primary PCI.
15737735|NCT04962178|Other|Optimal medical therapy with primary PCI not performed|The patients assigned to conservative strategy group will receive optimal medical therapy before primary endpoint accomplished.
15737736|NCT04962165|Device|Mandibular Advancement Device|The device maintain opened upper airway by moving the lower jaw slightly forward while sleeping.
15737737|NCT04962152|Drug|Nalbuphine Sebacate or Sesame oil (placebo)|ultrasound-guided intramuscular injection after the induction of anesthesia immediately
15737738|NCT04962139|Drug|ON101 Cream|Active ingredients: Extracts of Plectranthus amboinicus and Centella Asiatica
15737739|NCT04962139|Other|Vehicle Cream|ON101 Cream Placebo
15737740|NCT04962126|Drug|Obinutuzumab 25 MG/1 ML Intravenous Solution|"For intravenous infusion during:
~Induction phase: Day 1, 8 and 15 of cycle 1 & Day 1 of cycle 2-6 (q3/52); Maintenance phase: Day 1 of each cycle (q8/52) for up to 12 cycles."
15737741|NCT04962126|Drug|Atezolizumab 1200 MG/40mL Intravenous Solution|For intravenous infusion during induction phase only day 1 of each cycle q3/52 for up to 6 cycles.
15737742|NCT04962126|Radiation|4 Gy in 2 fractions|Involved site radiotherapy will only be administered to participants to achieve a PR/SD after at restaging after cycle 2, treatment will be between cycle 3 and 4 of induction treatment.
15737743|NCT04962113|Other|TUBE BATH|Wrap Tube Baht (immersion)
15737744|NCT04962100|Other|Analysis of capacitation-associated tyrosine phosphorylation in human sperm by flow cytometry|"After the assessment of the macroscopic and microscopic characteristics of the sample, we will wash the sample and process it using three layers of density gradients.
~In the case of samples for diagnostic analysis, the remaining volume will be incubated in at 37ºC, and 0.1-0.2 ml aliquots will be taken from the end of the processing at t0 (just before introducing the sample in the incubator), at t1 (after one hour of incubation) and at t3 (after 3 hours of incubation). Additionally, a sample will be taken after washing, prior to processing the sample with the density gradients. In the case of samples processed for insemination, an additional aliquot will be taken at the exact moment in which the insemination is carried out and the elapsed incubation time will be noted.
~The evaluation of the capacitation will be carried out by analyzing the state of phosphorylation of tyrosines by flow cytometry."
15737745|NCT04962087|Behavioral|Experimental: Health enSuite Insomnia|Health enSuite: Insomnia has been designed based on established cognitive behavioural treatments for insomnia and adapted to fit an automated interactive platform available via an internet enabled device. The program is divided into a series of treatment modules or levels that will be delivered over the course of 6-8 weeks. The content of these 6 levels includes the following components, a sleep diary, sleep restriction clock, sleep hygiene, relaxation techniques, sleep related thoughts and beliefs, and involving a support person.
15737746|NCT04962087|Behavioral|Experimental: Health enSuite Insomnia - Deprescribing|All participants in Trial 2 will be initiating a gradual medication tapering schedule recommended to them by their physician. The module physicians use to refer their patients to the study includes a section where they fill out a brief drug history for sleep medications. This information is then used to generate a tapering schedule that the health care provider will review with their patient. Health care providers are responsible for providing appropriate medication counselling and follow-up care to supervise deprescribing. This study does not place any restriction on the usual care participants will receive.
15737747|NCT04962074|Device|Microfluidic sperm sorting chip|Fertile Ultimate® (Koek Biotechnology, Turkey) microfluidic sperm sorting chips
15737748|NCT04962074|Device|Density gradient|Density gradient centrifugation
15737749|NCT04962061|Other|Cognitive Training|Participants will be encouraged to perform sessions of cognitive training 3 times per week (30 minutes/session). Two of these sessions will involve computer- or tablet-based attentional control training targeting dual-tasking, updating and working memory, as well as inhibition and switching. Difficulty of cognitive training will be tailored to participants' performances. The remaining session will consist of memory training. Participants will be instructed mnemotechnic, as well as be taught about memory in aging in general.
15737808|NCT04961541|Biological|ICC Vaccine|Intramuscular (deltoid) injections of in-clinic mix of various doses of qNIV2, SARS-CoV-2 rS, and 50 μg Matrix-M1 Adjuvant (ICC Vaccine) on Day 0 and Day 56.
15737750|NCT04962061|Other|Aerobic and resistance exercises|Participants will follow a periodized exercise training program with thrice-weekly 60 minutes trainings. The sessions will start with a 5-10mins warm-up, followed by aerobic and resistance trainings, and ends with a 5-10mins cool-down and stretching period. Intensity of aerobic sessions will be monitored with heart rate chest strap and should match with the moderate to vigorous intensity zone as defined by the ACSM (65% of Heart Rate maximum or more and a Perceived Exertion higher than 12 on the 6 to 20 Borg scale). Exercise intensity and duration will be gradually increased during the program. After aerobic training, a 15-20mins resistance training will be performed with a gradual progression of higher intensities and/or numbers of sets. The one maximal repetition (1RM) will be assessed for each RT movements at baseline, during (each 3 months) and at the end of the program. RT intensities will go from 40 to 70% of 1RM, with 8 to 10 forms of exercise involving majors muscle groups.
15737751|NCT04962061|Other|Stretching and Toning|Participants in the active control condition will take part in three 60 minutes stretching and toning sessions per week. Each session will start with a five-minutes warm-up, followed by fifteen min of body stretching exercises mainly in a seated position and finish with a five-minutes cool down. Participants will engage in four muscle-toning exercises (light intensity) using dumbbells or resistance bands, two exercises designed to improve balance, one yoga sequence, and one exercise of their choice. Intensity of stretching and toning sessions will be monitored with heart rate chest strap and should not exceed the light intensity zone as defined by the ACSM (64% of Heart Rate maximum or less and a Perceived Exertion lower than 11 on the 6 to 20 Borg scale).
15737752|NCT04962048|Device|pulse-synchronized negative pressure (PSNP) device|The machine consists of four components: an electrocardiograph (ECG), a vacuum pump, a software computing the timing of suction and drainage, and an individual suction cap for each patient. One leg will be treated with the PSNP-device. The treatment course with PSNP will be applied twice a day (with 4h +/- 2h in between) for two consecutive days.
15737753|NCT04962048|Other|Control - no intervention|The other leg serves as non-treated control
15737754|NCT04962035|Other|Neurocognitive Follow-up|Standard clinical and parent-reported outcomes on cognitive development, temperament and overall health conditions.
15737755|NCT04962022|Drug|PF-07321332/ritonavir|Administered orally every 12 hours for days for a total of 5 doses from Day 1 through Day 3
15737756|NCT04962022|Drug|Itraconazole|Administered orally once daily for 8 days from Days 1 through 8
15737757|NCT04962022|Drug|PF-07321332/ritonavir|Administered orally BID for 3 day for a total on 5 doses starting on Day 4 through Day 6
15737761|NCT04961983|Behavioral|Comprehensive Travel Health Education Model|"The comprehensive travel health education model consists of:
~Online training: 10 hours (2 days) online education via Zoom. The topics that will be delivered during the training includes:
~The potential roles of tour guides in tourists' health,
~The importance of travel health information for tourists,
~Assessment of tourist's health risks,
~Prevention and first aid of various travel health problems Topics related to tour guides will be delivered by the tourism experts, while topics related to travel health will be provided by travel medicine experts, Faculty of Medicine, Udayana University. Participants will also receive a travel health guide book.
~Weekly travel health Information sharing through WhatsApp group for 2 months."
15737762|NCT04961970|Drug|oxaliplatin , fluorouracil, and leucovorin|administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
15737763|NCT04961970|Drug|gemcitabine and cisplatin|administration of gemcitabine and cisplatin via vein
15737764|NCT04961957|Device|Waterproof padding|Apply waterproof padding to allow for normal bathing and water activities
15737765|NCT04961957|Device|Non-waterproof padding|Apply standard padding that does not allow for normal bathing and water activities
15737766|NCT04961944|Other|Disease assessment|"A comprehensive evaluation of the disease's extension, its impact on function, quality of life, and the search for phenotype/endotypes will be performed.
~The association between endotypes and disease progression will be tested."
15737767|NCT04961931|Drug|Empagliflozin 10 MG|After qualifying for the study all subjects received oral empagliflozin 10 mg once daily for 7 days.
15737768|NCT04961918|Procedure|Hepatic Arterial Infusion Chemotherapy (HAIC) Combine Lenvatinib and Durvalumab (HILL)|Hepatic Arterial Infusion Chemotherapy (HAIC) Combine Lenvatinib and Durvalumab (HILL)
15737769|NCT04961905|Drug|NVP-2002-R1+NVP-2002-R2|NVP-2002-R1 1 tablet, once daily and NVP-2002-R2 1 tablet, once daily
15737770|NCT04961905|Drug|NVP-2002|NVP-2002 is a combination of NVP-2002-R1 and NVP-2002_R2 NVP-2002, 1 tablet, once daily
15737771|NCT04961892|Procedure|surgical treatment|Anatomical contraction and termination reconstruction of the lateral ligament
15737772|NCT04961892|Procedure|conservative treatment|Rehabilitation intervention training
15737773|NCT04961879|Procedure|Reversed Cross Finger Flap|"distal dorsal finger defect will be reconstructed by reversed cross finger flap
~- reversed cross finger flap is a modified cross finger flap harvested from an adjacent finger ."
15737774|NCT04961879|Procedure|reversed island homo-digital flap|"distal dorsal finger defect will be reconstructed by reversed island homo-digital flap
~- this flap is harvested from the same finger ."
15737775|NCT04961866|Dietary Supplement|parenteral protein 1 g/kg|patients received 1 g/ kg of protein
15737776|NCT04961866|Dietary Supplement|Parenteral nutrition 2 g/kg|Patients received 2 g/ kg of protein
15737777|NCT04961853|Radiation|Ultrasound and MRI|Ultrasound examination and magnetic resonance imaging on the hand
15737781|NCT04961801|Drug|Acalabrutinib, tacrolimus, methotrexate|For Graft-Versus-Host Disease Prophylaxis in Allogeneic Hematopoietic Stem Cell Transplantation in Lymphomas and Leukemia
15737782|NCT04961788|Drug|Gemox combimed PD1 antibody|"Toripalimab (240mg) intravenously, the administration time is 60 (+15) minutes, Q3W is administered once.
~Gemox chemotherapy D1: oxaliplatin 85mg/m2, gemcitabine 1g/m2 D8: Gemcitabine 1g/m2 Three weeks is a course of treatment, a total of 6-8 courses."
15737783|NCT04961775|Drug|Perflubutane Microspheres for Injection|16 µL as perflubutane microbubbles (1 vial) is reconstituted with 2 mL of attached water for injection; usually, once for an adult, 0.015 mL/kg as dispersion is administered intravenously.
15737785|NCT04961749|Other|Whole body vibration training|Whole-body vibration training applies a vibration stimulus to an individual as they are standing on a side-alternating platform. The vibration creates small muscle contractions in the lower extremity musculature which has been shown to improve function and ambulatory function.
15737786|NCT04961736|Other|no intervention|This is an observation study, with no intervention
15737787|NCT04961723|Diagnostic Test|(OraQuick® HCV Self-Test|The OraQuick® HCV Self-Test is a lateral flow rapid diagnostic that can detect anti-HCV antibodies in oral fluid. Instructions for Use (IFU) for OraQuick® HCV Rapid Antibody Self-Test have been developed in Georgian for the previous 2 studies conducted in Georgia using the OraQuick® HCV Rapid Antibody Self-Test. The IFU has been optimized taking in the feedback on the IFU resulting from the aforementioned studies. As this HCV test is not approved for self-test use in Georgia, all tests will be labelled as Research Use Only (RUO) and test results will not be used for patient management.
15737788|NCT04961710|Drug|Hetrombopag Olamine|Hetrombopag Olamine; once daily
15737789|NCT04961710|Drug|Placebo|Placebo; once daily
15737790|NCT04961697|Behavioral|Hospital diaries|Diaries will be used by family members, PICU staff or even the patient himself. They will take daily notes expressing feelings and thoughts and describing events that might help chronologically to better understand the course of disease and PICU stay. Photographs and other important PICU memories may also be used in the diary.
15737791|NCT04961684|Device|Solver Pen|One application per day for 3 months
15737792|NCT04961684|Drug|Loceryl 5%|One application per week for 3 months
15737796|NCT04961658|Biological|GEM00220|Cryopreserved allogeneic, enhanced MSCs administered as a single intravenous infusion
15737797|NCT04961645|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|"TMS is a safe and noninvasive method for affecting brain function relying on the properties of electromagnetic induction. Action potentials are triggered in neurons, along with a subsequent period of deactivation. Normal ongoing brain activity is disrupted providing a way for investigators to produce a transient and reversible period of brain disruption.
~Participants will be seated comfortably in a chair and asked to complete either a simple computer-based task or a simple behavioral task that will require them to walk around in a small room. During or just before each of these tasks, participants will receive rTMS. In rTMS, a small plastic coil is placed next to the participant's head. The coil will be placed over the relevant brain region identified during the participant's fMRI scan. The coil will then generate a magnetic pulse, and stimulation will occur. The entire visit will last about one and a half hours."
15737798|NCT04961632|Drug|Tamoxifen|Patients taking 20mg tamoxifen will receive dose increments of 10mg every 8 weeks until endoxin threshold of >30nM or the maximum dose of 40mg/day is reached. The escalated dose will be taken for 1 year before reverting back to 20mg.
15737799|NCT04961632|Drug|Tamoxifen|Patients will take tamoxifen at the ascribed genotype-determined dose as determined in the dose-determination phase.
15737800|NCT04961619|Drug|dabrafenib|There is no treatment allocation. Patients administered dabrafenib by prescription that have started before inclusion of the patient into the study will be enrolled.
15737801|NCT04961619|Drug|trametinib|There is no treatment allocation. Patients administered trametinib by prescription that have started before inclusion of the patient into the study will be enrolled.
15737802|NCT04961606|Other|interview|semi-structured individual interview
15737807|NCT04961554|Other|loco-regional anesthesia|demonstrate that the mouth opening (measured in millimeters) of a patient treated for mandibular surgery with a very limited opening (defined by a threshold less than 20mm, not allowing the passage of a video laryngoscope blade per route buccal) is more important after locoregional anesthesia of the V3 than before anesthesia.
15737865|NCT04960982|Diagnostic Test|blood test|blood sample is taken in first, second and third trimester of pregnancy
15737809|NCT04961541|Biological|qNIV Nanoparticle Vaccine2 in-clinic mixed with Matrix-M1 Adjuvant|Intramuscular (deltoid) injections of 60 μg qNIV Nanoparticle Vaccine2 in-clinic mixed with 75 μg Matrix-M1 Adjuvant on Days 0, Day 56, and an additional dose on Day 70.
15737810|NCT04961541|Biological|SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with Matrix-M1 Adjuvant|Intramuscular (deltoid) injections of 5 μg SARS-CoV-2 rS Nanoparticle Vaccine in-clinic mixed with 50 μg Matrix-M1 Adjuvant on Days 0 and Day 56.
15737811|NCT04961528|Drug|Tranexamic Acid 500 MG|"Jet nebulization (a device connected by tubing to compressed air or oxygen to flow at high velocity through a liquid medicine to turn it into an aerosol, which is then inhaled by the patient).
~The nebulization lasts 10 minutes. Posology: 500 mg x 3/day (= 500 mg / 8 hours) Treatments duration: 5 days"
15737812|NCT04961528|Drug|Terlipressin|"Jet nebulization (a device connected by tubing to compressed air or oxygen to flow at high velocity through a liquid medicine to turn it into an aerosol, which is then inhaled by the patient).
~The nebulization lasts 10 minutes. Posology: 1 mg x 3/day (= 1 mg / 8 hours) Treatments duration: 5 days"
15737813|NCT04961528|Drug|Placebo|"Jet nebulization (a device connected by tubing to compressed air or oxygen to flow at high velocity through a liquid medicine to turn it into an aerosol, which is then inhaled by the patient).
~The nebulization lasts 10 minutes. Posology: 5ml x 3/day (= 5 ml / 8 hours) Treatments duration: 5 days."
15737814|NCT04961515|Drug|Orelabrutinib|Orelabrutinib dose escalation will occur using a standard 3+3 dose-escalation approach to determined the maximum tolerated dose(MTD) of orelabrutinib dose in combined regimen, beginning at dose level I (150 mg daily) and potentially escalating to dose level 2 (200mg) and dose level 3 (250mg) with rules for escalation and de-escalation. If the DLT is not found, the dose of 250mg qd will be used for phase II trial.
15737815|NCT04961515|Drug|Orelabrutinib|Orelabrutinib: orally maximum tolerated dose from phase 1b daily (150 mg or 200 mg or 250mg)
15737816|NCT04961515|Drug|Sintilimab|The dose of sintilimab is fixed dose. 200 mg intravenously every 3 weeks
15737817|NCT04961502|Biological|Blood test to describe the humoral and cellular response to vaccination BNT162b2 in the elderly|3 blood samples taken to compare the immunization response of the elderly with that of younger adults (priority caregivers): the first carried out before the anti-Coronavirus Disease 2019 (COVID-19) vaccination; the second shortly before the vaccination booster injection and the third approximately two months after the first vaccine injection
15737818|NCT04961476|Dietary Supplement|1-MNA|1-MNA supplementation
15737819|NCT04961463|Behavioral|psychoeducation|
15737820|NCT04961437|Other|Diaphragmatic ultrasound and electrical impedance tomography|"A diaphragmatic ultrasound in a half sitting position. The diaphragmatic excursion and the thickening fraction of the right hemi-diaphragm will be measured.
~- Acquisition of 10 minutes of regional pulmonary ventilation by electrical impedance tomography."
15737821|NCT04961411|Procedure|operation or non-operative treatment|type of operation or if possible non-operative treatment
15737822|NCT04961385|Biological|Immunogenicity after first dose of participants who received first dose of ChAdox-1 n COV-19 vaccine|Blood samples were taken from the vaccinated participants for antibody testing against SARS-CoV-2
15737823|NCT04961372|Other|Survey|PHQ9 Depression Scale for evaluating depression, GAD7 Anxiety Score for evaluating anxiety, WSAS Score for evaluating Work and Social Adjustment
15737824|NCT04961359|Biological|Recombinant new coronavirus vaccine (CHO cell) group|Intramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
15737825|NCT04961359|Biological|Recombinant new coronavirus vaccine (CHO cells) placebo group|Intramuscular injection of deltoid muscle of upper armof 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells) placebo.
15737826|NCT04961346|Device|Ultrapro® mesh|large-pore, lightweight polypropylene mesh
15737827|NCT04961346|Device|Premilene® mesh|small-pore, heavyweight polypropylene mesh
15737828|NCT04961333|Behavioral|Multidisciplinary Rehabilitation|Body therapies to improve breathing, normalise dysfunction in the autonomic nervous system, relaxation, mindfulness, in some part Acceptance and Commitment Therapy given preferably through body therapies.
15737829|NCT04961320|Behavioral|Occupational Therapy|Participate in OT session
15737830|NCT04961320|Other|Questionnaire Administration|Complete questionnaires
15737831|NCT04961307|Drug|Trastuzumab|30 female breast cancer patients using trastuzumab, collected demographic and clinical information of all patients before chemotherapy, performed echocardiography (conventional echocardiography, three-dimensional spot tracking technology), and collected blood samples to detect plasma biology Markers (TnT, BNP, GDF-15, topoisomerase
15737832|NCT04961294|Device|Electro-Acupuncture|Acupuncture used for thousands years is part of traditional Chinese medicine. We use electro-acupuncture to treat our patients because it is more sufficient than traditional acupuncture and proved effectively treating protracted withdrawal syndrome of opioid use disorder. Paired alligator clips of the EA apparatus will be attached to the needle holders of Shenmen and Neiguan points on both sides. EA stimulation will last for 30 min with a continuous wave of 2/100Hz and intensity of 10-15 mA which patients can stand. All needles will be removed in 30 min and use a dry sterilised cotton ball to press the points in case of bleeding.
15737833|NCT04961281|Drug|Dexmedetomidine|injection of Dexmedetomidine ( 10 microgram/kg) + 10 cc saline injection nearby median nerve as hydro-dissection
15737834|NCT04961281|Drug|Triamcinolone|injection of triamcinolone ( 40 mg) + 10 cc saline injection nearby median nerve as hydro-dissection
15737835|NCT04961268|Drug|TraMADol 50 Mg Oral Tablet|The patients were randomly given the medication by mouth 60 min before administering IANB.
15737836|NCT04961268|Drug|Tramadol 100 MG Oral Tablet|The patients were randomly given the medication by mouth 60 min before administering IANB.
15737837|NCT04961268|Drug|Ibuprofen 600Mg Tab|The patients were randomly given the medication by mouth 60 min before administering IANB.
15737838|NCT04961268|Drug|ibuprofen 600 mg/acetaminophen 1000 mg|The patients were randomly given the medication by mouth 60 min before administering IANB.
15737839|NCT04961268|Drug|Placebo|The patients were randomly given the medication by mouth 60 min before administering IANB.
15737866|NCT04960969|Other|Time-restricted feeding for 4 weeks|Participants in this group will follow a time-restricted diet for 28 days. Consumption of only non-energy drinks will be allowed for 16 hours. During the 8-hour eating period, there will be no restriction on the content of the diets.
15738521|NCT04955327|Drug|A. Paniculata and A. Chilensis|Combination of A. Paniculata and A. Chilensis
15737840|NCT04961242|Device|Together for Wellness digital mental health website|The intervention is a digital mental health resources website that includes multiple, free resources for broad public use. Different categories of resources include information on COVID-19 from CDC, multi-language versions of the UCLA Mindfulness App and other meditation programs, resources for families and social connection, including addressing discrimination or equity, and resource links.
15737841|NCT04961229|Biological|The Pfizer mRNA-based BNT162b2 vaccine|"participants who gave informed consent to participate in either the prospective non-randomised study or RCT will receive a single vaccine dose.
~In addition, participants in the RCT will be randomised into two groups:
~Third booster dose of BNT162b2 (one standard dose) with no change in immunosuppression protocol
~Third booster dose of BNT162b2 (one standard dose) with immunosuppression reduction according to protocol (mycophenolic temporary cessation 4 days before (5 half-lives) and one week (expected antibody response) after vaccination (to allow for antibody response)."
15737842|NCT04961216|Behavioral|OPTIMISE|Self-regulation intervention
15737843|NCT04961190|Behavioral|Prolonged Exposure Therapy|A form of cognitive-behavioral psychotherapy focused on imaginal exposure to trauma memories and in vivo exposure to trauma reminders
15737844|NCT04961190|Drug|Pharmacotherapy with paroxetine or venlafaxine XR|Standard dosing with paroxetine, a selectiveserotonin reuptake inhibitor that is FDA approved to treat PTSD and depression, or venlafaxine extended-release, a serotonin-norepinephrine reuptake inhibitor that is FDA approved to treat anxiety and depression
15737845|NCT04961177|Other|EITC & ACEs Training|We will deliver up to 56 trainings to 65 frontline health workers and 25 staff of our partner organizations. The training will include: 1.) Information about what ACEs are, and the risk and protective factors associated with ACEs and 2.) Information regarding EITC benefits, eligibility, application procedure and logistics, referrals for free tax preparation assistance, and use of EITC tools., and 3.) frontline health workers will receive additional training in protocols for reporting to support Objective #2.
15737846|NCT04961177|Other|EITC Outreach & Screening|"Our partners will screen and refer a minimum of 5200 clients (65 CHWs x 10 clients per quarter x 2 years) for EITC. Our evaluation team will track the number of individuals screened, the number found to be eligible/not eligible, the number referred out and to which free tax prep service, and if available, the number who use the free tax prep service, the number who file a tax claim for EITC, the number who receive EITC benefits, and the amount of the benefit.
~We will conduct community-level EIT outreach by integrating EITC outreach and education into planned community events in the neighborhoods and service areas of our partners. The events will provide information about the EITC to the public. We will have a minimum of 48 events to reach a minimum of 480 potential filers (48 events x 10 participants each)."
15737847|NCT04961177|Other|Assistance with EITC|"We will conduct a statistical analysis of the impact of EITC funds on ACEs risk and protective factors in the lives of EITC benefit recipients. Project CHW team members will invite 200 clients who qualify to receive EITC benefits to participate in the study using an approved recruitment script. With those who agree to participate, the CHW team member will obtain consent and administer a baseline survey. A post-survey will be administered at 4 months.
~In addition, we will gather qualitative data to help us understand impacts of this project. The post-survey will contain an open/qualitative response question asking participants to describe how the EITC benefit impacted them, how they felt when they received it, how important it was, and what they did with the funds. In Y2, the Research Team will conduct interviews with a subset of 20 clients who participated in the pre/post survey."
15737850|NCT04961151|Other|Multimodal therapeutic warming w/ esophageal d/c|In order to evaluate the ability to reliably raise patient temperature to a target of 39.0°C, patients will be warmed with forced air warming, surface conductive warming, and esophageal core warming. After 4 hours at target temperature, esophageal warming will be discontinued.
15737851|NCT04961151|Other|Multimodal therapeutic warming w/ conductive d/c|In order to evaluate the ability to reliably raise patient temperature to a target of 39.0°C, patients will be warmed with forced air warming, surface conductive warming, and esophageal core warming. After 4 hours at target temperature, conductive warming will be discontinued.
15737852|NCT04961138|Procedure|Transhepatic Arterial Chemotherapy And Embolization (TACE)|Receiving TACE and lenvatinib before surgery.
15737853|NCT04961138|Procedure|Surgery|Removing tumor by surgery.
15737854|NCT04961125|Genetic|germline variants|Variants of 139 genes associated with different hereditary cancers and polyposis were screened by next-generation sequencing.
15737855|NCT04961112|Device|Cranial Electrotherapy Stimulation|Participants will receive cranial electrotherapy stimulation stimulation on one of two separate visits (within-subjects).
15737856|NCT04961112|Device|Sham Cranial Electrotherapy Stimulation|Participants will receive sham stimulation on one of two separate visits (within-subjects).
15737857|NCT04961099|Drug|HY01|low-dose group: HY01 10mg（20mg/ml）, administrated on D1, D4 and D7 high-dose group: HY01 20mg（40mg/ml）, administrated on D1, D4 and D7
15737858|NCT04961086|Other|energy drink|An easily available 250 ml branded energy drink will be randomized to the partcipants after informed consent. Before and thirty minutes after drinking the given energy drink the participant cognition, heart rate, blood pressure and blood glucose will be measured.
15737859|NCT04961047|Behavioral|Digital neurotherapy (DNT) Treatment|The experimental group will have 8 weeks of DNT 4 times a week for 30 minutes in the participant's home. The computer-presented training will be done on the participants' tablets or personal computers with the Rejuvenate brain training program
15737860|NCT04961047|Behavioral|Wait list control group|Waiting-list control group participants will be offered 8 weeks of DNT training at the completion of the final outcome assessment.
15737862|NCT04961021|Procedure|Strabismus surgery|Strengthening of medial rectus muscle or strengthening of medial rectus muscle with weakening of the lateral rectus muscle
15737863|NCT04961008|Other|Bottle-PEP|A device that gives positive pressure from a bottle with the help of a non deflating tube
15737864|NCT04961008|Other|Routine physiotherapy|Routine pulmonary physiotherapy
15738522|NCT04955327|Drug|Microcrystalline cellulose|Placebo comparator
15737867|NCT04960943|Drug|Pyrotinib with or without trastuzumab|After enrollment, patients of all the three cohorts were given 400 mg/d oral pyrotinib continuously, every 21 days as a cycle; Cohort 1 and 2 : Patients with gastric cancer or esophageal adenocarcinoma were combined with paclitaxel 80 mg/m2, intravenously, once on the first and eighth day. Cohort 3: Patients with colorectal cancer were given trastuzumab at an initial load dose of 8 mg/kg followed by 6 mg/kg every 3 weeks.
15737868|NCT04960930|Drug|FMX101|topically once daily
15737869|NCT04960917|Behavioral|Evaluation of ehealth literacy workshop|Intervention components will include a three session workshop, enabling participants to raise their knowledge of the different available health resources and how to find them, their ability to determine which health resource is reliable, their ability to use the health information online to make health decisions, their knowledge of the online services offered by HMOs/Ministry of Health, and their ability to navigate HMO and preform actions such as set an appointment, find a doctor, and find contact information
15737870|NCT04960904|Device|Dental implant surgery with implants|Adult patients who have had dental implant surgery.
15737871|NCT04960891|Biological|Tebentafusp|Concentrate solution for intravenous infusion
15737872|NCT04960878|Dietary Supplement|Synbiotic|Synbiotics sachet mainly contained Lactobacillus rhamnosus HN001, Bifidobacterium lactis HN019, and fructooligosaccharides.
15737873|NCT04960878|Dietary Supplement|Placebo|Maltodextrin
15737874|NCT04960865|Other|Kinesio Taping under tension.|Kinesio tape will be applied to participants under tension.
15737875|NCT04960865|Other|Kinesio Tape without tension|Kinesio tape will be applied to participants without any tension.
15737876|NCT04960865|Other|Rigid Taping|Rigid Taping will be applied.
15737877|NCT04960852|Other|a single shade structurally colored universal resin composite|Omnichroma is a single shade composite that is claimed to have blending effect with the tooth color, thus eliminate shade matching procedures during restorative treatment
15737878|NCT04960839|Radiation|Prophylactic contralateral breast irradiation|The whole contralateral breast will be irradiated once daily, 5 days a week, for 5-6 weeks, using 1.8-2 Gy/fx to a total dose of 45-50 Gy.
15737879|NCT04960813|Behavioral|Structured games|"Camp Kidpower - Structured Games is an interactive, child-friendly camp and is comprised of short, game-like exercises taught by camp counselors to groups of approximately 4-6 children. In total, 15 different exercises will be taught. Children will attend 5 three-hour playgroup sessions over a 4-week period (twice the first week, and then only once per week for the subsequent 3-week period) to match the Playgroup intervention.
~Parents will be asked to attend an approximately one-hour group meeting, during which information is presented regarding child anxiety, effortful control and the rationale for this treatment. Parents are asked to continue to utilize the intervention at home every day if possible with the child and will receive texts or emails to track the games that are played at home."
15737880|NCT04960813|Behavioral|Playgroup|"Camp Kidpower - Playgroup includes structured play activities. This will include art activities, dramatic play props, and a story time. Children will attend 5 three-hour playgroup sessions over a 4-week period (twice the first week, and then only once per week for the subsequent 3-week period) to match the Kidpower intervention.
~During the first week parents will attend an approximately one-hour group meeting, during which information is presented regarding the positive benefits of child-led play and special time with caregivers.
~Parents well be asked to complete homework with their children during the week between sessions, and are shown how to track time spent in this activity. Parents will receive a daily text (or email) to to measure frequency of homework practice between sessions."
15737881|NCT04960800|Other|Specific exercises|Specific exercises which aims to contract the recti abdominis combined with functional exercises with the aim to contract all the layers of the anterior abdominal wall. Strengthening dosage will be applied with 3 sets, containing between 8 and 12 repetitions of maximal load.
15737882|NCT04960787|Other|Educational Intervention|Watch online educational videos
15737883|NCT04960787|Behavioral|Patient Navigation|Meet with CENTS counselor and PAF case manager
15737884|NCT04960787|Other|Quality-of-Life Assessment|Ancillary studies
15737885|NCT04960787|Other|Questionnaire Administration|Complete questionnaires
15737886|NCT04960774|Other|Observational study, no intervention|Observational study, no intervention
15737887|NCT04960761|Other|İntervention Group|"In the experimental group, pre-operative anxiety and quality of life scales will be applied to the child and their parents before and after the operation with audio and picture books, the preoperative quality of life scale will be made, the postoperative anxiety and quality of life scale will be repeated and the early mobilization scale will be made.
~The control group will be routinely informed before the operation, an anxiety scale will be given to the child and their parents before the operation, a quality of life scale will be given to the child, the postoperative anxiety and quality of life scale will be repeated, and early mobilization form will be applied."
15737889|NCT04960735|Other|VOICE intervention|"The intervention consists of four stages:
~S1, Value identification and description of current care processes: Needs are detected from two perspectives: feedback from patients and mapping of healthcare processes. ICHOM questionnaires are reviewed. Patient surveys and clinical forms are developed. The methodology for cost analysis is set up.
~S2, Intervention implementation: Patients are recruited according to the eligibility criteria. Their care follows the current healthcare pathway and information is collected at different time points.
~S3, Assessment of outcomes and continued benchmarking: Data and costs are analysed at both local level and Community level (benchmarking). Interviews and focus groups are held (optional). Root cause analysis is performed.
~S4, Model construction: Based on the process mapping and on root cause analysis, the multidisciplinary team designs the new care pathway. Professionals are trained in those tasks allocated according to the new care process."
15737890|NCT04960722|Device|OIF/β-TCP|bone graft implantation
15737898|NCT04960683|Device|Lokomat training|"Control group will receive the routine conventional physiotherapy treatment and the treatment for this group consists of the following:
~Conventional therapy protocol:
~5 sessions of 45 minutes a week, each session includes:
~5 minutes of stretching exercise
~20 minutes of strengthening exercise
~10 minutes of balance exercise
~10 minutes of gait training
~Experimental group will receive 45 min of Lokomat in addition to the conventional approach (as explained above). Since Lokomat appointments can be only 8 per day, it is planned to have two groups of 8 participants for 4 weeks each. The Lokomat training include the following:
~5 sessions of 45 minutes of conventional therapy (same as above) per week
~5 sessions of 45 minutes on Lokomat per week"
15737899|NCT04960670|Other|Evaluation of microbiome and maternal/infant lifestyle|Identification of the longitudinal interplay between the intestinal microbiome and infant/maternal nutritional and lifestyle habits, environmental factors exposure and anthropometric measurements, in children with adiposity rebound vs children with early adiposity rebound.
15737900|NCT04960657|Drug|glibenclamide|Oral administration of glibenclamide/placebo. To investigate the role of PACAP38 on cranial arteries in healthy volunteers after glibenclamide/placebo administration .
15737901|NCT04960657|Drug|PACAP38|PACAP38 infusion
15737902|NCT04960644|Drug|MTX|MTX (5-10 mg/day,Dmax 10mg/day) was given on days 1, 3, and 8, and repeated weekly until aGVHD was CR
15737903|NCT04960644|Drug|Corticosteroid|corticosteroid Methylprednisolone 1 mg/kg/day was given for 10 days and then the dosage was gradually reduced according to patient's response
15737904|NCT04960631|Diagnostic Test|Double site CT guided needle biopsy|Double site CT guided needle biopsy
15737905|NCT04960618|Drug|Gemcitabine|Participants will receive gemcitabine 1000 mg/m2 on days 1 and 8 on 21-days cycles for up to 6 cycles
15737906|NCT04960618|Drug|Pembrolizumab|Pembrolizumab 200 mg will be introduced with cycle 2 and will be given on day 1 of each 21-day cycle for up to 35 cycles
15737907|NCT04960605|Procedure|Dental implants|Treatment of the toothless regions with dental implants
15737908|NCT04960592|Device|Spinal Cord Stimulation|Temporary implantation of a clinical available neurostimulator.
15737909|NCT04960579|Biological|P-BCMA-ALLO1 CAR-T cells|Allogeneic BCMA-targeted chimeric antigen receptor (CAR) T-cell therapy
15737910|NCT04960579|Drug|Rimiducid|Safety switch activator
15737911|NCT04960566|Other|Cognitive Behavioral Therapy|The CBT intervention is based on the theoretical framework that under stress (reflux symptoms) a person makes a rapid cognitive appraisal of the potential threat (automatic thoughts), leading to both emotional and physical responses in the body, thereby reacting behaviorally (avoidance, increased HCU) in an attempt to mitigate unpleasantness. CBT is a collaborative, present-focused treatment that utilizes a skills-based approach with home practice exercises. CBT targets automatic thoughts and appraisals of threat via education, self-monitoring of stressors and symptoms, and strategies to reframe problematic thinking patterns to more adaptive ones. Resonance frequency breathing (RFB) is achieved when a person breathes at a pace, typically 4 to 6 breaths per minute, that engages the body's baroreflex to modulate arousal. Prior research demonstrates 4 to 6 weeks of RFB training is sufficient to significantly increase baseline HRV with enduring effects for up to 6 months.
15737912|NCT04960566|Other|Sham-SOC Lifestyle Coaching|Sham-SOC Lifestyle Coaching
15737913|NCT04960553|Device|Exufiber® and Mepilex® Border Flex|Post Market Clinical Follow-up Investigation applying Exufiber® and Mepilex® Border Flex to 102 subjects who meet the study criteria for up to 12 weeks
15737914|NCT04960540|Other|MRI,|"In this project, multi-modal brain imaging methods, such as resting-state functional MRI, task-state functional MRI, structural MRI and diffusion tensor imaging, will be used to analyze brain structure, gray matter morphology, white matter fibrous brain functional activation mode and brain functional connectivity network, and other dimensions.
~In particular, combined with the brain functional activities of ALS patients in the cognitive processing task of language understanding and language use, the brain network damage of ALS patients in motor and executive function was compared, and the neural activities and network mechanism of specific changes in language cognitive processing in ALS patients were investigated. Combined with the clinical neuropsychological behavior evaluation data"
15737915|NCT04960527|Dietary Supplement|Tart cherry juice|250 mL tart cherry juice (30 mL tart cherry concentrate [CherryActive, UK] diluted with 220 mL water) is consumed on a single occasion by each participant. This will be consumed immediately following the baseline measurements one laboratory visit.
15737916|NCT04960527|Other|Water|250 mL water is consumed on a single occasion by each participant. This will be consumed immediately following the baseline measurements one laboratory visit.
15737917|NCT04960514|Diagnostic Test|KidneyIntelX|KidneyIntelX is a blood-based clinical diagnostic tool that assesses the risk of progressive kidney function decline in chronic kidney disease patients with type 2 diabetes.
15737918|NCT04960501|Procedure|New type of tension band or patellar tension reduction band for treatment of lower pole fracture of patella|New type of tension band or patellar tension reduction band for treatment of lower pole fracture of patella
15737919|NCT04960488|Procedure|carotid endarterectomy and coronary artery bypass grafting|carotid endarterectomy and coronary artery bypass grafting
15737920|NCT04960475|Other|Hospital Anxious and Depression(HADS)|The assessment content in the scale is divided into two parts: anxiety and depression. Anxiety is an unexplained state of restlessness, manifested as tension, fear, and panic all day long. Depression is manifested as depression, slow thinking, decreased volition and physical symptoms. The two parts are scored separately. A total score of 0-7 means normal, a total score of 8-10 means mild depression/anxiety, a total score of 11-14 means moderate depression/anxiety, and a total score of 15-21 means severe depression/ anxiety.
15737921|NCT04960475|Other|Fear-Avoidance Belief Questionnaire (FABQ)|FABQ is a self-assessment questionnaire with 16 options. Each option has 7 levels of 0-6 points, representing totally disagree, uncertain, and totally agree; there are 2 subscales, and one subscale measures the fear-avoidance in physical activity, another subscale measures fear-avoidance of work. The final score of FABQ is the superposition of the value of each item. A high score indicates a high level of fear-avoidance beliefs.
15737922|NCT04960475|Other|The MOS 36-Item Short From Health Survey (SF-36)|The SF-36 is a multi-purpose survey designed to capture adult patients' perceptions of their own health and well-being. The SF-36 has 36 items grouped in 8 dimensions: physical functoning, physicial and emotional limitations, social functioning, bodily pain, general and mental health.
15738062|NCT04959279|Other|ED-TREAT|Patients will be assessed and treated based on a clinical decision support system.
15737923|NCT04960462|Procedure|nerve root sleeve reinforcement|treatment of sacral cysts in patients with sacral cysts by using nerve root sleeve reinforcement
15737924|NCT04960449|Procedure|shoulder arthroscopy|Patients underwent ubacromial bursectomy and acromioplasty , cuff debridement and cuff repair, side to side suture of rotator cuff combined with suture anchor.
15737925|NCT04960436|Procedure|Meniscus Allograft Transplantation|patients received surgery of Meniscus Allograft Transplantation
15737926|NCT04960436|Procedure|Meniscectomy|patients received surgery of Meniscectomy
15737927|NCT04960423|Procedure|Long Segment Fixation and Fusion|Long Segment Fixation and Fusion
15737928|NCT04960410|Combination Product|Types and exposure of different air pollutants|Types and exposure of different air pollutants in COPD patients' living and working environment
15737931|NCT04960384|Drug|FGF-2|The FGF-2 method of use comprises a pledget of gelatin sponge, with human fibroblast growth factor-2 (FGF-2) added to the pledget just before topical application to the tympanic membrane, and the use of fibrin glue used for applications in ear surgery. The concentration of the FGF-2 solution will be 100μg of FGF-2 per 1 mL with an estimated dose of about 20 μg in 0.2ml. Fibrin glue will be applied to secure gelatin sponge after placement according to the size of the membrane perforation. Application of the study treatment will occur at Visit 1 and may be repeated at each follow up visit as needed for a maximum of three treatments in the Randomized Treatment Phase (Visit 1, Visit 2, and Visit 3).
15737932|NCT04960384|Drug|Placebo|FGF-2 will be replaced with sterile water to saturate a pledget of gelatin sponge. The method will be otherwise identical to the FGF-2 intervention.
15737933|NCT04960371|Diagnostic Test|coronary flow reserve (CFR)|Coronary flow velocity profiles in the left anterior descending artery were obtained using colour-guided pulse wave Doppler. We measured peak diastolic coronary flow velocity of the diastolic coronary waveform at rest and after ATP infusion (140 µg/kg. min) for 2 min. The CFR was calculated as the ratio of hyperaemic peak diastolic velocity to resting baseline diastolic velocity. All patients abstained from caffeine-containing drinks for at least 24h before testing.
15737934|NCT04960358|Procedure|Surface Electromyography|will be applied Surface Electromyography to assess Flexion Relaxation Response
15737935|NCT04960345|Device|Brainlab Knee 3|Brainlab knee 3 navigation system is a kind of imageless computer-assisted navigation system.
15737936|NCT04960332|Device|Prevena|RCT (no blinding) where the patients will be randomized to wound closure with staples and either Negative Pressure Wound Therapy (PREVENA PLUS™ Incision Management System) for 7 days or a conventional wound dressing.
15737937|NCT04960319|Device|Intravascular Lithotripsy|Coronary Angiography. When the anatomic inclusion criteria are met, traverse the lesion with a guidewire. If traversal fails, assign the subject to the registry. After wire traversal has been documented by cine angiography, angiographic, OCT-defined or balloon expansion criteria are met, subject is enrolled. Blood sample for Troponin (hs TnT) baseline measurement has to be taken. The subjects will be randomized in a 1:1 fashion to treatment with either IVL or RA.
15737938|NCT04960306|Biological|Fecal filtrate transplantation|"Patients will receive 5-8 encapsulated lyophilized fecal filtrate transplantations in enterosolvent, size 0 capsules. Before intervention patients will receive proton pump inhibitors and prokinetics. After the preparation, the participants will be instructed to swallow the capsules one by one within 5 minutes with fluid to help to swallow the capsules."
15737939|NCT04960306|Biological|Conventional fecal microbiota transplantation|"Patients will receive 5-8 encapsulated lyophilized conventional fecal microbiota transplantations in enterosolvent, size 0 capsules. Before intervention patients will receive proton pump inhibitors and prokinetics. After the preparation, the participants will be instructed to swallow the capsules one by one within 5 minutes with fluid to help to swallow the capsules."
15737940|NCT04960293|Procedure|uterine artery embolization using spherical gelfoam|Uterine artery embolization is performed using spherical gelfoam. All other processes are same.
15737941|NCT04960293|Procedure|uterine artery embolization using tri-acryl gelatin microsphere|Uterine artery embolization is performed using tris-acryl gelatin microsphere. All other processes are same.
15737942|NCT04960280|Device|©CompuSteth stethoscope|Computerized auscultation detects both infrasound and audible sounds and is capable of amplifying auscultated sounds by a factor of thirty.
15737943|NCT04960267|Device|Use of pre-peritoneal drainage after rTAPP|Use of pre-peritoneal drainage after rTAPP
15737944|NCT04960254|Behavioral|internet gaming addiction|"The Strengths and Difficulties Questionnaire (SDQ) parent versionIt is 25 questionnaires to screening behavioural in children about 4-17 year-olds. It divided into 5 scales (the emotional symptoms, conduct problems, hyperactivity/inattention symptoms, peer relationship problems and prosocial behaviour).
~Socioeconomic Scale:It contains four main variables:1-The educational level of the father and mother.2-The occupation of the father and mother. 3-Total family income. 4-life style of the family.
~Emotional Avoidance Strategy Inventory for Adolescents (EASI):The EASIA is a 17-item (Kennedy & Ehrenreich-May 2017) measure assessing the use of emotionally avoidant strategies in adolescents.
~The internet gaming addiction scale : t is used to evaluate internet gaming addiction."
15737945|NCT04960241|Procedure|Homebased telerehabilitation|The telerehabilitation intervention is based on sensor technology, developed by ICURA. The technology consists of motion sensors that can measure and analyse the quantity and quality of the exercises, and a mobile application that can guide the patients with visual response. A unique feature of ICURA trainer allows the physiotherapist to remotely supervise the individual patients exercise adherence and progress. The patients will receive a suitcase with five sensors (to be placed bilaterally on lower legs, thighs and one around the waist), a smartphone to record the exercises and a charging station free of charge during the 6-week intervention. At the end of the intervention the material will be returned at the first follow-up (t1). For more information please visit https://icura.dk.
15738063|NCT04959266|Drug|Adavosertib|Patients will receive a single dose of Adavosertib orally in arm A, B, and C.
15738064|NCT04959266|Drug|Itraconazole|Patients will receive Itraconazole orally once daily for 7 days in arm A.
15740447|NCT04938869|Other|Medical Device Usage and Evaluation|Use CGM device and app
15737946|NCT04960241|Procedure|Homebased rehabilitation|The unsupervised rehabilitation group will receive a written exercise program in order to perform daily exercises at home. The exercise program will be made using Exorlive (for more information about Exorlive please visit https://www.exorlive.com). In addition to the written program, patients will able to use a link provided to see small video-instructions on the internet of each exercise on the program. No feedback or supplementary instructions will be given after the initial face-to-face appointment.
15737947|NCT04960241|Procedure|No physical rehabilitation|Patients allocated to the no intervention group will receive encouragement to stay active and be encouraged to gradually return to activities of daily living. This will be the only exercise-encouragement given to the no-intervention group.
15737950|NCT04960215|Drug|Coenzyme Q10|Coenzyme Q10 (myoquinon) capsule 100mg, 5 capsules a day.
15737951|NCT04960215|Drug|Placebo|A soft gelatin capsule containing α-tocopherol, 5 capsules a day.
15737955|NCT04960189|Procedure|Acupuncture|Acupuncture will be performed bilateral on fibular aspect of the leg, in the depression anterior and distal to the head of the fibula by using 0,25x50mm needles.
15737956|NCT04960176|Procedure|Acupuncture|Acupuncture will be applied by using 0,25x25mm needles.
15737957|NCT04960176|Procedure|Non-invasive Sham Acupuncture|Non-invasive sham acupuncture will be applied by using blunted 0,25x25mm needles.
15737958|NCT04960163|Other|No intervention|No intervention
15737959|NCT04960150|Device|Press tack needle|"Press tack needle acupuncture using Seirin Pyonex sized 0.20x1.2mm"
15737960|NCT04960150|Device|Plesterin|Plesterin
15737961|NCT04960137|Device|button plates fixation system|The button plates fixation system consists of fixing plate, prefabricated mix, button and fuse. In the process of use, the fuse plays the role of guiding the fixed plate through, pulling the button and shortening the distance between the button and the fixed plate. The prefabricated mix is pre-worn between the button and the fixed plate, and the lead pulls the distance between the fixed plate and the button after tightening and fixing. Prefabricated mix, make mix tight and knot. Finish the preliminary work of fixing.
15737962|NCT04960137|Device|Non-absorbable Suture Anchor|A conventional device used in surgery for shoulder dislocation.
15737964|NCT04960111|Device|RSA|application of tantalium microsphere around knee prosthesis and RSA X-ray post operative to detect early mobilization in follow up.
15737965|NCT04960098|Procedure|arthroplasty|patient with hip and knee osteoarthritis underwent hip and knee arthroplasty
15737966|NCT04960085|Device|echocardiography|philips IE33
15737967|NCT04960072|Biological|Tumor Infiltrating Lymphocytes (TIL)|Adoptive transfer of 1x10^9-3x10^11 autologous TILs to patients i.v. in 30-120 minutes.
15737968|NCT04960059|Other|No intervention|This is an observational study
15737969|NCT04960046|Procedure|Placement of an infraclavicular perineural catheter using a costoclavicular approach|"The high-frequency linear probe will be used to image the axillary artery in the long axis and nearby nerve structures of interest, namely the posterior, lateral and medial bundles. The plane chosen will be located inferior to the clavicle, also in its distal third. The needle will be inserted with a latero-medial orientation in the plane. The initial injection will be a single injection laterally to the axillary artery, where the three nerve bundles are still joined together.
~The catheter will then be positioned and its location verified by injecting an additional 5 mL of ropivacaine into the catheter under direct ultrasound visualization. Catheter fixation will be standardized to minimize the risk of accidental displacement and the point of entry of the catheter to the skin will be covered with an opaque dressing."
15737970|NCT04960046|Procedure|Placement of an infraclavicular perineural catheter by paracoracoid approach|"The high-frequency linear probe will be used to image the axillary artery in the short axis and nearby nerve structures of interest, namely the posterior, lateral and medial bundles. The plane chosen will be located inferior to the clavicle, in its distal third. The needle will be inserted with a cranio-caudal orientation in the plane. The initial injection will be a single injection posterior to the axillary artery, the expected distribution being a U distribution around the artery.
~The catheter will then be positioned and its location verified by injecting an additional 5 mL of ropivacaine into the catheter under direct ultrasound visualization. Catheter fixation will be standardized to minimize the risk of accidental displacement and the point of entry of the catheter to the skin will be covered with an opaque dressing."
15737971|NCT04960033|Behavioral|FRAX|The 10-year MOF probability and the 10-year HF probability were calculated using the FRAXs of different regions (mainland China, Hong Kong, Taiwan, and Asia-America). Subjects were deemed as high-risk for osteoporotic fracture if the 10-year probability of MOF was ≥20% or the 10-year probability of HF was ≥3%.
15737972|NCT04960020|Other|Retrospective Data Review|Retrospective Data Review
15737973|NCT04959994|Device|Novel Motorized Spiral Enteroscopy|All the patients with suspected small bowel disease and an indication to undergo total enteroscopy and satisfying inclusion criteria will undergo novel motorized spiral enteroscopy
15737974|NCT04959981|Drug|ERAS-007|ERAS-007 will be administered orally as specified in Arm description.
15737975|NCT04959981|Drug|osimertinib|80 mg orally once daily
15737976|NCT04959968|Device|eye patch and earplug|The use of eye patch and ear plugs in post-operative intensive care in craniotomy cases.
15738065|NCT04959266|Drug|Rifampicin|Patients will receive Rifampicin orally once daily for 13 days in arm B.
15738066|NCT04959266|Drug|Omeprazole|Patients will receive Omeprazole orally once daily for 5 days in arm C.
15737977|NCT04959942|Other|scapular stabilization exercise|In the supine position, the subject will instruct to take a deep breath to relax the body. In croock-lying position, the subject will raise his dominant arm to 90° shoulder flexion with full elbow extension and scapular protraction. In the quadruped position, the subject lifts up his arms alternatively with shoulder abduction and 120 ° flexion. In a sitting position with 90° knee flexion on a stool or bed without back support, the subject held a pair of dumbbells (2 kg) in each hand and laterally lifted them up while maintaining the height of scapulae below 80°. Each stage will instruct to be held for 10 seconds before returning to the starting position and three laps of 10 repetitions with a 30-second break in between will perform. In the sitting position, a mirror will place in front of the patient. The subject will instruct to check and correct his posture by him
15737978|NCT04959942|Other|postural correction exercise|The program consisted of two strengthening (deep cervical flexors and scapular retractors) and two stretchings: cervical extensors (sub-occipital muscles) and pectoral muscles). The program was based on a program by Harman and Kendall.
15737979|NCT04959942|Other|advice|all subjects will be instructed to maintain normal alignment of the cervical vertebry
15737980|NCT04959929|Device|Focal vibration therapy|Myovolt is a wearable rehabilitative device that delivers vibration with a frequency between 60-300 Hz, and acceleration force between 1.8g to 19.1g peak to peak. Myovolt intensity will be set to ~up to 2X the participant's initial Myovolt perception threshold. If the stimulation does not feel strong, the participant will be asked to manually increase the intensity until it feels strong but comfortable. During the first 3 weeks of the study, participants will be asked to use the device for 2 individual 0.5-hour sessions daily, once in the morning and once in the evening. During the second 3 weeks of the study, participants will be permitted to continue using the device for 2 individual 0.5 hour sessions per day, or to wear the device so that it automatically alternates between 0.5-hour treatment and 0.5-hour rest periods for up to 2 hours of stimulation daily before locking out.
15737982|NCT04959903|Biological|Allogeneic T cell progenitors, cultured ex-vivo|Injection of T cell progenitors at [Day 4-Day 10] after T cell depleted allogeneic HSCT
15737983|NCT04959890|Other|Retroviral Insertion Site Analysis|Shearing extension primer tag selection ligation-mediated polymerase chain reaction (S-EPTS/LM-PCR) retroviral insertion site (RIS) analysis on samples previously collected from subjects treated with Strimvelis
15737984|NCT04959877|Behavioral|health education|data collect / Telemedicine
15737985|NCT04959864|Dietary Supplement|Isitol®|"1 sachet of Isitol® (2,1g) contains :
~1000 mg of myo-inositol ;
~300 mg of N-acetyl-cystein ;
~48.5 mg of zinc citrate (equivalent zinc pure element : 15 mg) ;
~35 mg of D-a-tocopherol (equivalent vitamin E pure element : 12 mg) ;
~16 mg of vitamin B3 ;
~1.8 mg of pyridoxin hydrochloride (equivalent vitamin B6 pure element : 1.4 mg) ;
~1.4 mg of vitamin B2 ;
~0.37 mg of (6S)-5-methyltetrahydrofolic acid, glucosamine salt (equivalent vitamin B9 pure element : 0.2 mg).
~Sachets are packaged in box of 30."
15737986|NCT04959864|Other|Placebo|"1 sachet of placebo (2,1g) contains :
~1765.1 of maltodextrin ;
~300 mg of magnesium carbonate ;
~40 mg of citric acid ;
~5.3 mg of beta-carotene ;
~2.16 mg of silicon dioxide ;
~1.44 mg of sucralose.
~Sachets are packaged in box of 30."
15737987|NCT04959838|Behavioral|Impact of prolonged work|Evaluate the impact of prolonged work (up to 60 consecutive hours) on the surgical capacities evaluated on a simulator, as well as on stress markers (questionnaires, saliva assays, skin conductance, quality of sleep) compared to a standard day.
15737988|NCT04959825|Drug|Melatonin 5 mg|study the effect of preoperative oral melatonin 5mg on isoflurane consumption and postoperative pain
15737989|NCT04959825|Drug|Sugar Coated Tablets|the control group patients will receive placebo tablets one hour before induction of anesthesia
15737990|NCT04959812|Drug|Sufentanil|Subjects will receive Sufentanil while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.
15737991|NCT04959812|Other|Placebo|Subjects will receive a placebo pill while the effects of this placebo on tolerance to a hemorrhagic insult will be assessed.
15737992|NCT04959799|Drug|Dalbavancin|Adult diabetic patients suffering from infections who received the last dose of dalbavancin according to the current standard clinical practice at least 30 (+7) days before enrolment in the study.
15737993|NCT04959786|Drug|Ivermectin,ribavirin ,nitazoxanide and zinc|oral intake of the 3 drugs ivermectin ,ribavirin and nitazoxanide plus zinc
15737994|NCT04959760|Diagnostic Test|The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2.|The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2 in fingestick capillary blood and plasma samples.
15737995|NCT04959747|Other|acupuncture|"Body acupuncture will choose eight acupoints as Yingxiang (LI20),Shangxing (GV23), BiTong, Yintang, Hegu. Disposable acupuncture needle (0.25 mm in diameter and 25-30mm in length) are inserted at a depth of 10-25 mm obliquely into scalp acupuncture points (ShangXing, YinTang) and straightly into face/body acupuncture points (Yingxiang, BiTong, Hegu).
~We will also deliver electro-acupuncture will be applied to the face points at fast and dispersed waves through electric needle stimulator which is provided by Chinese Medicine Clinic (ES-160 6-Channel Programmable electro-acupuncture) for 30 minutes."
15738021|NCT04959487|Other|Food support|1. Diabetes-tailored food support. Project Open Hand will provide intervention participants six months of supplemental food support meeting on average 75% of their daily energy requirements. Food support will consist of a mix of meals tailored for T2DM, and T2DM-healthy groceries, consistent with American Diabetes Association (ADA) guidelines for diabetes healthy diets under the responsibility of a registered dietitian.
15738067|NCT04959253|Combination Product|Psilocybin assisted therapy|A package of psychological therapy and a single dosing session of psilocybin.
15740448|NCT04938869|Other|Survey Administration|Ancillary studies
15737996|NCT04959721|Combination Product|Injection with triamcinolone acetonide, bupivacaine, and normal saline|"Triamcinolone acetonide is a synthetic corticosteroid medication used intra-articularly to treat various joint conditions. Bupivacaine is a medication used to decrease feeling in a specific area. In nerve blocks, it is injected around a nerve that supplies the area, or into the spinal canal's epidural space. Saline is most commonly used as a sterile 9 g of salt per litre (0.9%) solution, known as normal saline.
~The procedure will be performed with the patient in a prone position under a C-arm fluoroscopy scanner, with the thorax rests on 2 pillows, flexing the neck maximally, and the head turns 60-90° away from the side of injection. The C-arm tube will be angled cephalad, until it was at a tangent to the cervical facet joint space. A 26-gauge, 90 mm spinal needle will be inserted parallel to the C-arm beam. To confirm intra-articular placement of the needle tip, an arthrogram of the cervical facet joint will be performed by injecting 0.3 mL of contrast."
15737997|NCT04959708|Other|Insula treatment|he intervention will consist of twelve individual treatments. Insula method consists of the facilitation and activation of self-regulation resources, relational regulation through breathing, movement, contact, sensory stimulation and posture
15737998|NCT04959695|Behavioral|PE Coach|PE Coach is a treatment companion mobile application designed with features to support the tasks of prolonged exposure psychotherapy and the homework between sessions.
15737999|NCT04959695|Behavioral|Prolonged exposure without PE Coach|Standard PE treatment protocol without PE Coach
15738000|NCT04959682|Other|Music Intervention|After rating levels of fatigue and relaxation, the professional health care musicians will play 30 minutes of patient-tailored, pleasant instrumental music with a combination of relaxing (on average 60-80 bpm) and lively, slightly more up-beat tempo to regulate arousal-levels
15738001|NCT04959669|Other|DeSSBack|The DeSSBack (Decision Support System for Low Back Pain) is a decision support tool developed in the University of Malaya Medical Centre's (UMMC) electronic medical record system by adopting and re-packaging the STaRT system to suit the local context. It stratifies patients with low back pain to low, medium or high risk, which are then managed differently. The DeSSBack has also been incorporated the local clinical practice guidelines and feedback from local experts.
15738002|NCT04959630|Behavioral|Clinical decision making based on visualizing liver 3D models in Virtual Reality (VR) environment or via a Desktop Interface (DI)|Visualizing 3D models of livers for preoperative surgical planning via two different environment: DI and VR in sequential order
15738003|NCT04959617|Device|Quantitative Fecal Immunochemical Test (qFIT)|The study only included quantitative FIT examination in the general physical examination population over 30 years old.
15738004|NCT04959604|Procedure|ICG-marking endoscopically|Preoperatively the participants will receive an endoscopic marking at four points around the tumour with the fluorescent dye indocyanine green.
15738005|NCT04959591|Drug|intravenous acetaminophen|experimental(pre): administration of IV acetaminophen
15738006|NCT04959591|Drug|intravenous acetaminophen|experimental(post): administration of IV acetaminophen
15738007|NCT04959591|Drug|Placebo|placebo comparator: administration of normal saline
15738008|NCT04959578|Drug|Recombinant human erythropoietin|Dose, route and schedule was kept same as previous erythropoietin dose at randomization; adjusted as necessary (+/- 25% of the starting dose) to maintain Hb within 11 - 12 g/dL.
15738009|NCT04959578|Drug|Darbepoetin Alfa|Dose conversion (100U erythropoietin = 0.42 mcg darbeopoetin). DA dose was kept once weekly (QW) if previously receiving rHuEpo ≥2 times a week, or Q2W if previously receiving rHuEpo <2 times a week. Dose was adjusted as necessary (+/- 25% of the starting dose) to maintain Hb within 11 - 12 g/dL.
15738010|NCT04959565|Behavioral|Nutritional behavioral intervention|The participants will get access to an online platform where the FUEL recovery program will be initiated with session 1 immediately after baseline testing and the athletes are requested to follow the lectures lead by highly experienced sports dietitians for the respective weeks. Every other week for 16 weeks (8 sessions in total) participants will be offered individual nutrition counselling (one intervention group) by highly experienced sports nutritionists in each country, based on Motivational Interviewing, the individual's environmental and biological prerequisites, and the Transtheoretical Model, focusing on the individual's readiness to act on a new healthier behavior
15738011|NCT04959565|Behavioral|Nutritional behavioral intervention|The participants will get access to an online platform where the FUEL recovery program will be initiated with session 1 immediately after baseline testing and the athletes are requested to follow the lectures lead by highly experienced sports dietitians for the respective weeks.
15738012|NCT04959552|Device|FreeStyle Libre 2|The FreeStyle Libre 2 Flash Glucose Monitoring
15738013|NCT04959539|Procedure|endoscopic transcanal tympanoplasty with attico-antrostomy|Transcanal approach followed by atticotomy to remove the attic cholesteatoma sac
15738014|NCT04959539|Procedure|endoscopic assisted canal wall up mastoidectomy|traditional canal wall up mastoidectomy followed by endoscopic evaluation of the attic to exclude any remnant cholesteatoma
15738015|NCT04959526|Diagnostic Test|Shear-wave elastography|Ultrasound based imaging of diaphragm muscle activity
15738016|NCT04959513|Procedure|LPRF bone block|Guided bone regeneration using an L-PRF bone block (composite graft composed of a xenograft, a membrane from the patient's blood and a collagenous membrane) after a short healing period of 6 to 8 weeks after tooth extraction
15738017|NCT04959500|Drug|Anlotinib Hydrochloride|Drug: Anlotinib Hydrochloride Anlotinib hydrochloride will be given with a daily dose of 12 mg for 14 days of a 21-day cycle up to 2 cycles, initiated on the first day of radiation therapy and followed by adjuvant treatment with the same dosing schedule until patients have disease progression or intolerable toxicities.
15738018|NCT04959500|Drug|Placebo|Drug: Placebo Placebo will be given with a daily dose of 12 mg for 14 days of a 21-day cycle up to 2 cycles, initiated on the first day of radiation therapy and followed by adjuvant treatment with the same dosing schedule until patients have disease progression or intolerable toxicities.
15738019|NCT04959500|Radiation|Radiation Therapy|Radiation: Radiation therapy Radiation therapy will be delivered in daily fractions of 1.8-2.0 Gy given 5 days a week for a total of 54-60 Gy.
15738020|NCT04959500|Drug|Temozolomide|Drug: Temozolomide Temozolomide will be administered at a daily dose of 75 mg/m2 until the completion of radiation therapy. Four weeks after the completion of radiation therapy, patients will be given with adjuvant chemotherapy with temozolomide at a dose of 200 mg/m2 for 5 days of a 28-day cycle for a total of 6 cycles.
15738117|NCT04958811|Drug|Atezolizumab|1200mg IV administered every 3 weeks.
15738022|NCT04959487|Other|Nutritional Counseling and education|2. Nutritional counseling and education: The registered dietitian will provide individual nutritional counseling two times (at baseline and month 5-6) during the intervention. In addition, group-based DM nutrition education will be conducted over four 1-hour-long sessions. The nutrition education will be conducted by a POH dietitian, and the curriculum will be consistent with published diabetes self- management education principles, utilizing effective strategies in lower wealth, lower literacy populations.
15738023|NCT04959474|Other|Best Practice|Given standard dietary recommendations
15738024|NCT04959474|Radiation|Stereotactic Body Radiation Therapy|Undergo SABR
15738025|NCT04959474|Procedure|Sentinel Lymph Node Biopsy|Undergo sentinel lymph node biopsy
15738026|NCT04959474|Other|Questionnaire Administration|Ancillary studies
15738027|NCT04959474|Other|Quality-of-Life Assessment|Ancillary studies
15738028|NCT04959474|Procedure|Resection|Undergo surgical resection
15738029|NCT04959474|Other|Dietary Intervention|Undergo a caloric restriction diet
15738030|NCT04959461|Behavioral|webCHAT|A self-guided, single session web intervention that utilizes a motivational interviewing style to prevent impaired driving
15738031|NCT04959461|Behavioral|Usual Care|6 hours of driver education
15738032|NCT04959448|Drug|DUPIXENT®|No investigational agents will be provided. All treatments will be prescribed at the discretion of the study physician and other healthcare providers.
15738033|NCT04959435|Other|biological samples collection|samples of blood, faeces, saliva, dental plaque, oral mucosa, genital mucosa
15738034|NCT04959422|Other|Active scheduling|Active scheduling, tracking and rescheduling, if necessary.
15738035|NCT04959409|Drug|Topical analgesia (EMLA or AMETOP)|Whether topical analgesia has or has not been administered to each child prior to them receiving an inhalational induction of anaesthesia
15738036|NCT04959396|Device|IUB SEAD|The investigative device, the IUB SEAD™, is a novel spherical endometrial ablation device developed to allow for simple, office-based chemical EA to treat benign causes of the symptom of HMB
15738037|NCT04959383|Other|Low complexity Exergaming group|This group will receive 30 minutes of Exergame Balance Training on Modified wobble board 3 times a week for 8 weeks. Wobble board will be able to rock in all direction with Weight Transfer. Wobble board based exergame balance training group game complexity will be kept low for this group.
15738038|NCT04959383|Other|Moderate complexity Exergaming group|This group will receive 30 minutes of Exergame Balance Training on Modified wobble board 3 times a week for 8 weeks. Wobble board will be able to rock in all direction with Weight Transfer. Wobble board based exergame balance training group game complexity will be kept moderate for this group.
15738039|NCT04959383|Other|High complexity Exergaming group|This group will receive 30 minutes of Exergame Balance Training on Modified wobble board 3 times a week for 8 weeks. Wobble board will be able to rock in all direction with Weight Transfer. Wobble board based exergame balance training group game complexity will be kept high for this group.
15738040|NCT04959383|Other|Control Group|This group will receive 30 minutes of Exergame Balance Training on Modified wobble board 3 times a week for 8 weeks. This group will receive exergame balance training on Wii fit. Participants in this group will play Soccer Heading, Ski Slalom, Ski Jump, Table Tilt, Tightrope Walk, Balance Bubble, Penguin Slide and Snowboard Slalom game.
15738041|NCT04959370|Device|internal fixation implantation of dynamic hip screw|Dynamic hip screws (DHS) are a femoral head-sparing orthopedic device used to treat femoral neck fractures.
15738042|NCT04959370|Device|internal fixation implantation of cannulated compression screw|Cannulated Screw is designed to provide a minimally invasive method of anatomical fixation.
15738043|NCT04959357|Diagnostic Test|Two dimensional speckle tracking imaging|lobal longitudinal strain and strain rate, subendocardial LS and subepicardial LS were quantified by two dimensional speckle tracking imaging
15738044|NCT04959344|Biological|Kleb4V target dose|Two doses of the non-adjuvanted Kleb4V target dose will be administered intramuscularly 2 months apart
15738045|NCT04959344|Biological|Kleb4V target dose + AS03|Two doses of the adjuvanted Kleb4V target dose will be administered intramuscularly 2 months apart
15738046|NCT04959344|Biological|Kleb4V low dose|Two doses of the non-adjuvanted Kleb4V low dose will be administered intramuscularly 2 months apart
15738047|NCT04959344|Biological|Kleb4V low dose + AS03|Two doses of the adjuvanted Kleb4V low dose will be administered intramuscularly 2 months apart
15738048|NCT04959344|Biological|Placebo|Two doses of the Placebo will be administered intramuscularly 2 months apart
15738049|NCT04959331|Drug|Fosfomycin Trometamol Salt|Fosfomycin 3 g 2 sachets, taken orally, once daily for two days
15738050|NCT04959331|Drug|Nitrofurantoin|Nitrofurantoin 50 mg pills, taken orally, two pills/8 hours, for five days
15738051|NCT04959331|Drug|Pivmecillinam|Pivmecillinam 400 mg pills. taken orally, one pill/8 hours, for three days
15738052|NCT04959331|Drug|Fosfomycin Trometamol Salt|Fosfomycin 3 g one sachet, taken orally, for one day
15738053|NCT04959318|Other|Professional nutrition counseling|Published multi-cohort genome-wide association studies provided genes and genetic variants that are credibly associated with aspects of metabolic syndrome (MetS), CVD, overweight/obesity, and vitamin D metabolism. Registered dietitian (RD) counseling will review potentially harmful and protective variants for risk of MetS with subjects and make evidence-based recommendations to improve diet quality and achieve weight loss goals. Each of the 6 weekly sessions covered a specific component of MetS. Counseling will take place once a week either in-person or via phone/virtual platform based on preference and availability of the subject. Counselors will review digital app data entries for food intake prior to this interaction for the first 2 weeks.
15738054|NCT04959318|Other|No professional nutrition counseling|Participants receive pamphlets with evidence-based general health, healthy nutrition, exercise and sleep content. They receive information on genetic variants related to MetS at end of study period.
15738055|NCT04959305|Drug|HCP1803-3|Take it once daily for 8 weeks orally.
15738056|NCT04959305|Drug|RLD2003|Take it once daily for 8 weeks orally.
15738057|NCT04959305|Drug|RLD2004|Take it once daily for 8 weeks orally.
15738058|NCT04959305|Drug|RLD2005|Take it once daily for 8 weeks orally.
15738059|NCT04959305|Drug|HPP2003-3|Placebo drug. Take it once daily for 8 weeks orally.
15738060|NCT04959305|Drug|HPP2005|Placebo drug. Take it once daily for 8 weeks orally.
15738061|NCT04959292|Diagnostic Test|arthroscopy|arthroscopy
15738068|NCT04959253|Combination Product|Placebo assisted therapy|A package of psychological therapy and a single dosing session of placebo.
15738069|NCT04959240|Drug|Velmanase Alfa|
15738070|NCT04959227|Other|Sema activity|sema activity 3 days a week for at least a year
15738071|NCT04959214|Behavioral|progressive relaxation egzersize|Performing exercises in a quiet environment for 45 minutes with the Turkish Psychologists Association CD. Filling the PSQI and FSS before and 1 month after the application
15738072|NCT04959201|Drug|NMDAE plus AO|Use of an NMDA enhancer plus a drug with antioxidant property for the treatment of schizophrenia.
15738073|NCT04959201|Drug|NMDAE plus Placebo Cap|Use of an NMDA enhancer plus placebo as a comparator.
15738074|NCT04959175|Drug|Mycophenolate Mofetil|15 mg/kg orally or IV three times daily (max 1000 mg/dose) starting on day +5, continued through day +35. May be continued beyond the protocol specified stop date if there is GVHD or mixed chimerism.
15738075|NCT04959175|Procedure|Allogeneic HSCT|Stem cell transplant
15738076|NCT04959175|Drug|Fludarabine|30 mg/m2 IV infusion over 30-60 minutes once daily for 5 days (Pre-Transplant days -6 through -2).
15738077|NCT04959175|Drug|Sirolimus|Loading dose of 6 mg orally given on day +5 (calculated based on actual body weight, max initial dose 6 mg), then maintenance dose starting at 2 mg orally daily on day +6 with dose adjustments to maintain a trough of 5-12 ng/ml, continued through day +60 with no taper. May be continued beyond the protocol specified stop date if there is GVHD or mixed chimerism.
15738078|NCT04959175|Drug|Filgrastim|begins on day +5 at a dose of 5 mcg/kg/day (actual body weight) IV or subcutaneously, until the absolute neutrophil count is > 1,000/mm3 over the course of three days or > 5,000/mm3 on one day. Rounding to the nearest vial is allowed. G-CSF may be stopped early or not administered if required by the clinical circumstance. Additional G-CSF may be administered as warranted.
15738079|NCT04959175|Drug|Cyclophosphamide|Pre-transplant: 14.5 mg/kg/day IV daily for 2 days pre-transplant (Pre-Transplant days -6 and -5). Post-transplant: 25 mg/kg/day or 35 mg/kg/day (Post-transplant days +3 and +4).
15738080|NCT04959175|Drug|Mesna|25 or 35 mg/kg (equal to the cyclophosphamide dose) as IV infusion concomitant with cyclophosphamide. Mesna may or may not be given with the pre-transplant cyclophosphamide depending on institutional practice.
15738081|NCT04959175|Procedure|Total Body Irradiation (TBI)|400 centigray (cGy) to be delivered in 2 fractions as 200 cGy per fraction twice daily. Pre-Transplant Day -1 (or Day 0 prior to graft administration)
15738082|NCT04959162|Device|E-learning|Development of theoretical knowledge using a E-learning platform before attending a hands-on course in musculoskeletal ultrasound
15738083|NCT04959162|Device|Conventional preparation|Attending a hands-on course in musculoskeletal ultrasound with no preparation before course start
15738084|NCT04959149|Device|AirTraq videolaryngoscope|intubation of morbidly obese patient using Airtraq videolaryngoscope
15738085|NCT04959136|Device|Ambulatory Monitoring Solution|Aim is to evaluate PR; RR; NIBP, cNIBP, SpO2 and arterial blood pressure with investigational Ambulatory Monitoring Solution (AMS)
15738086|NCT04959123|Other|pharmacokinetic analysis|Non-compartmental descriptive pharmacokinetic analysis (i.e. without the need for mathematical modelling), with determination of the pharmacokinetic parameters of interest either directly from the experimental points (Cmax, Tmax), or from simple mathematical equations (calculation of the area under the curve (AUC) by the trapezoidal method, calculation of the terminal slope of elimination)
15738087|NCT04959110|Diagnostic Test|Pharmacokinetic study|"Start CVVH session with isotonic citrate solution (13.3 mmol/L) as predilution, targeting citrate dose at 3 mmol/L
~Blood samples collection at pre-filter for citrate concentration, blood gas, electrolyte and ionized calcium and magnesium
~In addition, 10 minutes after the end of citrate infusion, blood samples were taken simultaneously from both pre-filter and post-filter to calculate citrate clearance by filter"
15738088|NCT04959084|Other|Laser acupuncture therapy and pelvic floor training|The laser will be applied directly to the skin over acupuncture points and each point receive a shoot of 65 seconds followed by Pelvic floor exercises for 15 min.
15738089|NCT04959071|Procedure|Vacuum assisted closure VAC vs conventional dressing|"In participants undergoing vacuum assisted closure a drainage tube was placed in the wound followed by dressing with sterile foam sheet and application of occlusive transparent film over the whole assembly. The drainage tube was connected to a suction machine. Intermittent negative pressure of -125mmHg was applied every 15 minutes; the suction was stopped for 10 minutes. The dressing was changed every 48 hours.
~In participants with conventional dressings, after wound wash, pyodine soaked gauze pieces were used for initial 48 hours followed by dressings of normal saline soaked gauze pieces, twice daily."
15738090|NCT04959058|Device|Volunteer|An ultrasound machine will be used to calculate the elastographic value of the brachial plexus in three different positions.
15738091|NCT04959045|Other|intervention group (Flipped Teaching Method Group)|"Students will be given skill training with the Flipped Teaching method, which consists of outside and in-class applications.
~Out-of-Class Practice: A Learning Management System-Web-Based Distance Education System will be created for the Flipped Teaching method. Theoretical course topics and skill training videos will be uploaded to the system 7 days before the course day. Students will be able to watch the video tutorials in the number and frequency they want until the day of the lesson. At the end of the lesson, the mini-exam will be uploaded to the system.
~In-class practice: The researcher will come to the lesson prepared for classroom activities such as question and answer. Theoretical lectures and skill demonstrations will not be made by the researcher. The researcher will only guide the students. Then, the students will be provided to perform the skill under the guidance of the researcher in the clinical skills laboratory."
15738092|NCT04959032|Drug|Lumateperone 42 mg|Lumateperone 42 mg capsules administered orally, once daily.
15738093|NCT04959032|Drug|Placebo|Matching capsules administered orally, once daily.
15738118|NCT04958811|Drug|Bevacizumab|15mg/kg IV administered every 3 weeks.
15738119|NCT04958798|Behavioral|Culturally Centered MOUD Implementation Intervention|Support clinical sites to culturally center the delivery of medications for opioid use disorder through evidence-based implementation strategies tailored to local needs
15738123|NCT04958772|Biological|Filgrastim Megalabs|Filgrastim Megalabs 5 μg/Kg/day, subcutaneous single dose
15738094|NCT04959019|Behavioral|Supervised combined endurance and resistance training (CERT)|Subjects will undergo up to 18 supervised sessions of a structured exercise program of combined endurance and resistance training (CERT). Supervised CERT will occur for 3 days/week, approx. 1 hr per session. Endurance training will start at 15 minutes and progress to 30 minutes of cycling on a stationary recumbent bicycle at 65-85% of heart rate reserve by week 3. Resistance training volume and intensity (baseline determined from strength tests) will progress over the first four sessions to 3 sets of 8-12 repetitions to volitional fatigue for 8 movements, with alternating upper-body and lower-body movements during the session. Progression will be incorporated throughout the trial for both endurance and resistance training to maintain relative intensity.
15738095|NCT04959019|Behavioral|Delayed supervised combined endurance and resistance training (CERT)|After a 6-week delay period (no-exercise control), subjects will undergo up to 18 supervised sessions of a structured exercise program of combined endurance and resistance training (CERT). Supervised CERT will occur for 3 days/week, approx. 1 hr per session. Endurance training will start at 15 minutes and progress to 30 minutes of cycling on a stationary recumbent bicycle at 65-85% of heart rate reserve by week 3. Resistance training volume and intensity (baseline determined from strength tests) will progress over the first four sessions to 3 sets of 8-12 repetitions to volitional fatigue for 8 movements, with alternating upper-body and lower-body movements during the session. Progression will be incorporated throughout the trial for both endurance and resistance training to maintain relative intensity.
15738096|NCT04959006|Dietary Supplement|Antioxidant supplement|Short term (16d) supplementation of either the antioxidant supplement (Oliphenolia) or placebo. Participants required to consume 2x25ml drinks, one mid-morning, one mid-afternoon between meals.
15738097|NCT04959006|Dietary Supplement|Placebo|Placebo
15738098|NCT04958993|Drug|Anlotinib hydrochloride capsule Combined With Concurrent Chemoradiotherapy|radiotherapy (five days a week to accept chest radiotherapy, once per day, every time 1.8-2.0 Gy, total dose 54-66 Gy) AND chemotherapy (Squamous cell carcinoma selective platinum + docetaxel and Adenocarcinoma selective platinum + Pemetrexed) AND Anlotinib Hydrochloride capsule (12mg QD PO d1-14, 21 days per cycle)
15738099|NCT04958980|Behavioral|Specific and educational guidelines on care for pathology (diabetes mellitus) according to each profession involved in the research|"Physician: Guidance on pathology, sequelae and treatment, as well as guidance on the importance of medical monitoring.
~Dental surgeon: guidance on oral health, demonstration of brushing techniques and daily flossing and periodontal changes resulting from diabetes mellitus.
~Nurse: Guidance on pathology prioritizing pathophysiology, self-care and skin care and wound prevention (vascular sequelae).
~Nutritionist: nutritional guidelines on diabetes mellitus and healthy eating habits.
~Physiotherapist: guidance on prevention of falls and injuries and health promotion.
~Physical educator: guidance on the importance of practicing physical activities for general health, encouraging self-care and body awareness and demonstrating basic physical activities that can be performed at home."
15738104|NCT04958928|Procedure|Catheter ablation|All patients received radiofrequncy ablation.
15738105|NCT04958915|Diagnostic Test|Knee joint 30° flexion scan|The patient was placed in the supine position, and the knee joint was naturally placed in the knee joint special coil, and the knee joint 30° flexion position scan.
15738106|NCT04958902|Behavioral|RESTORE: Recovering from Extreme Stressors Through Online Resources and E-health|RESTORE (www.restoreonline.ca) includes eight e-modules anticipated to be approximately 30-40 minutes each in length and intended to be completed over 4-8 weeks. The modules address cognitive and behavioural factors posited to cause and maintain psychological distress related to the COVID-19 pandemic. These include cognitions about the cause and meaning of stressors related to the pandemic, including self-blame, other blame and hindsight bias, as well as problematic beliefs related to safety, trust, and control. The modules also address the importance of: (1) expressing emotions that are natural to the events of the pandemic (e.g., sadness in the face of loss), (2) working through, rather than avoiding, thoughts, feelings and grief related to the pandemic, and (3) utilizing social supports. The modules consist of written materials, brief videos, and practice assignments delivered through the platform. RESTORE includes guidance via direct messaging and/or brief telephone calls.
15738107|NCT04958889|Other|No intervention|(observational study)
15738108|NCT04958876|Drug|SP-104|oral capsule once daily
15738109|NCT04958876|Drug|Naltrexone immediate release oral capsules|oral capsule once daily
15738110|NCT04958863|Other|Surgical mask|Use of a surgical mask during test
15738111|NCT04958863|Other|Polyester reusable mask|Use of a polyester reusable mask during test
15738112|NCT04958850|Other|a cross-sectional survey|Collect the data of this year and compare it with that of ten years ago
15738113|NCT04958837|Other|FIFA 11+ protocol with additional Core training exercises|Slow paced running exercises of 8 minutes' duration (2 rounds each), followed by Strength, plyometric and balance exercises including 3 sets of 20-30 sec of The Bench, Sideways Bench each side, Nordic Hamstring strengthening, single leg stance balance training, squatting and high speed running. The protocol will end with additional core training exercises including leg raises, crunches, superman, plank hip twist, and supine bridge. Each exercise plan will be progressively increased. Core training will be followed by 30 sec stretch of major muscle groups.
15738114|NCT04958837|Other|FIFA 11+ protocol|Slow paced running exercises of 8 minutes' duration including running straight, running with hip out, running hip in, running circling partner, running shoulder contact and running quickly forward and backwards (2 rounds each), followed by Strength, plyometric and balance exercises including The Bench, Sideways Bench each side, Nordic Hamstring strengthening and single leg stance balance training, squatting and jumping. All exercises will be progressively increased as per established protocol. The final phase of the study includes fast running for 2 minutes.
15738115|NCT04958824|Diagnostic Test|Pharmacogenetic test|Pharmacogenetic test results for Cytochrome P450 genes are examined for markers of variant metabolism.
15738116|NCT04958811|Drug|Tiragolumab|600mg IV administered every 3 weeks.
15738125|NCT04958759|Other|Functional Inspiratory Muscle Training|The inspiratory muscle training program will be consist of 4 weeks of foundation inspiratory muscle training and 6 weeks of functional inspiratory muscle training
15738126|NCT04958759|Other|Inspiratory Muscle Training|The inspiratory muscle training program will be consist of 10 weeks of foundation inspiratory muscle training
15738127|NCT04958759|Other|Breathing exercises|The program will be consist of 10 weeks of breathing exercises
15738128|NCT04958746|Drug|Ciprofol|intravenous bolus
15738129|NCT04958746|Drug|Propofol|intravenous bolus
15738130|NCT04958733|Procedure|Autologous bone grafting|Autologous bone grafting is the excess bone obtained from graft preparation and the coring reamer
15738131|NCT04958733|Procedure|Absence of autologous bone grafting|Donor sites will be left unfilled
15738132|NCT04958720|Procedure|Surgery|Surgery
15738133|NCT04958720|Drug|Chemotherapy, anti-targeted agents and immunotherapy|Chemotherapy, anti-targeted agents and immunotherapy
15738134|NCT04958720|Radiation|Radiotherapy|Radiotherapy
15738135|NCT04958707|Other|Information including knowledge and skills related to dementia patient care|The intervention will be administered to the participants via a smartphone app (Zalo app). Weekly, the investigator will post one of the eight topics identified in Phase 1 in the chat room. After posting the topic, one investigator will call the participants to ensure they read and understand the contents.
15738136|NCT04958694|Behavioral|CEDARS|This intervention is intended to help adolescents cope with stress.
15738137|NCT04958681|Other|exercise|The participants were subsequently asked whether the pandemic had altered their physical activity status and rate the severity of reduction in mobility level compared to the period before the Covid-19 with the following options: none, 0; mild, 1; moderate, 2; severe, 3. Then, the participants were also asked whether they perform a physical exercise in a home setting. We recorded regular outdoor physical activity and home-based exercises (only after the pandemic) as a dichotomous variable (yes or no). The number of physical activity days per week was also obtained.
15738138|NCT04958668|Other|Post-operative intensive care using volatile sedation|Patients admitted after valve surgery are receiving intensive care using volatile sedative per anaesthetic conserving device. The subject of the study is medical and nursing time management..
15738139|NCT04958655|Behavioral|Tetris Task|a visual task where participants are asked to play 'tetris' i.e. attend to and manipulate shapes and positions on screen
15738140|NCT04958655|Behavioral|Mental Imagery for Craving Reduction|a behavioural mental imagery intervention where participants are asked to generate a specific future mental image to reduce cue-induced craving for alcohol
15738141|NCT04958642|Drug|Adrabetadex|Mallinckrodt test formulation, adrabetadex (VTS-270), administered via lumbar intra-thecal infusion
15738142|NCT04958629|Other|familial hypercholesterolemia|Among the selected patients with hyperlipidemia, those who met the diagnostic criteria of FH were included in the study cohort as FH group.
15738143|NCT04958616|Diagnostic Test|Skin prick test.|Skin prick test: for (Dermatophagoides pteronyssinus and Dermatophagoides Farina). Through the use of specific allergen extracts, positive and negative controls, then interpretation after 15-20 minutes of maneuver, a wheal ≥3 mm diameter is considered positive [9]. Before the test, we checked that the patient has not taken medications that might interfere with the test and antihistamines had stopped using before the skin prick test (2 days for the first generation and 7 days for the second generation)
15738144|NCT04958603|Procedure|"L type release surgery"|Lateral release of the lateral support belt
15738145|NCT04958590|Radiation|whole spine X-ray|Group 1 underwent whole spine X-ray in standing and sitting positions.
15738147|NCT04958564|Device|DCP|"Dynamic compression plating to compress the fracture
~Intramedullary device to share the load."
15738148|NCT04958551|Other|No intervention|No intervention
15738149|NCT04958538|Drug|Methotrexate|Methylprednisolone 2 mg/kg/day MTX (5-10 mg/day) was given on days 1, 3, and 8, and repeated weekly until aGVHD was less than grade II
15738150|NCT04958525|Procedure|Keyhole neuroendoscopic transfrontal ultrasound-guided hematoma removal|Keyhole neuroendoscopic transfrontal ultrasound-guided hematoma removal in basal ganglia region:According to the brain CT scan and reconstruct the operation plan, choose a side by 2 cm before the coronal suture line 4 cm and 3 cm center longitudinal incision formation of 2 cm bone drilling the hole, ultrasonic measurement and the size of hematoma puncture depth, and guide the puncture direction, the transparent channel under endoscopic direct placement hematoma backend, after entering the hematoma cavity, under the neural endoscopic removal of hematoma,Wash the hematoma cavity with warm salt water.Bipolar electrocoagulation hemostasis for active bleeding.An indwelling drainage tube was placed in the hematoma cavity, and ultrasonography determined that the hematoma was cleared satisfily without active bleeding.
15738151|NCT04958525|Procedure|Small bone window craniotomy for hematoma removal under microscope|Small bone window craniotomy for hematoma removal under microscope:Small bone window craniotomy in frontotemporal region, no blood vessels and non-functional areas of the hematoma nearest to the cortex was cut open, the hematoma was removed under the microscope and the cavity of the hematoma was washed with warm saline, and bipolar electrocoagulation hemostasis was performed for active bleeding.An indwelling drainage tube was placed in the hematoma cavity and the operation was completed without active bleeding.
15738152|NCT04958512|Drug|Yangxue Qingnao pill|The treatment group (20 cases) was treated with Yangxue Qingnao pill (2.5g / time, 3 times / day, orally for 6 months
15738153|NCT04958512|Drug|Hydergotoxine mesylate tablets|The control group (n = 20) was treated with hidezhen 3 mg per day before meals for 6 months
15738154|NCT04958512|Other|blank control group|There were 20 cases in the blank control group.Outpatient consultation at any time was prescribed.
15738303|NCT04957212|Drug|Carboplatin|A dose of AUC6 (area under the plasma concentration-time curve) every 3-weeks
15738304|NCT04957212|Drug|Docetaxel|75 mg/m2 every 3-weeks
15740449|NCT04938856|Drug|Lamotrigine tablet|Lamotrigine 100 mg immediate release Tablet
15738155|NCT04958499|Behavioral|Bio-healthy Park|Experimental group will receive the exercise program on bio-healthy machinery with a frequency of 2 sessions per week of 55 minutes for 8 weeks. Experimental group 1 will perform the intervention program using machinery designed for self-loading use. The machines used will be rider, low gemini, high gemini, walk, bottoms, flywheels circles, flywheels rotation, twin swing, surf, swing press and rowing. Intensity will be controlled by subjective perception of effort and heart rate (Polar 420). There will be a warm-up 8-10 minutes, a main part 40-45 minutes and a return to calm 5-10 minutes. The intervention programs will be developed by a graduate in Physical Activity and Sport Sciences. The load will be progressed every 2 weeks.
15738156|NCT04958486|Drug|5-Azacytidine and trastuzumab infusion|Patients will receive once weekly 10 mg intraventricular 5-Azacytidine infusions for six consecutive weeks followed by observation in the infusion suite for a minimum of 30 minutes and once weekly 21 mg intraventricular trastuzumab infusions for six consecutive weeks followed by observation for a minimum of 2 hour after each infusion for the first 2 infusions. During this monitoring period, temperature, blood pressure, heart rate, and oxygen saturation will be measured. Patients will also have a neurological examination performed to observe for neurological changes. All patients will undergo an MRI of the brain and total spine with and without gadolinium within 7 days after the final 5-AZA and trastuzumab infusion to determine treatment response and to assess for any signal changes in the brain or spine caused by the infusions and they will have a 30 day and a 90 day follow-up assessment by telephone or in person for assessment of outcome measures and safety
15738157|NCT04958473|Drug|Sintilimab|PD-1 inhibitor，Sintilimab 200mg IV, every 3 weeks.
15738158|NCT04958473|Drug|Axitinib|Tyrosine kinase inhibitor，licensed for use in treatment of renal cell carcinoma. Oral treatment Axitinib given 5 mg PO BID.
15738159|NCT04958460|Drug|Placebo|Administrated 1 packet of maltodextrin (as placebo of Bf-688) in the morning and evening
15738160|NCT04958460|Other|BF688|Administrated 1 pack each morning and evening (5×109 CFUs per day)
15738161|NCT04958434|Drug|TST005|TST005 is a bifunctional human immunoglobulin G1 (IgG1) monoclonal
15738162|NCT04958421|Device|PiCSO Impulse System|After blood flow restoration, the subjects meeting all eligibility criteria will be enrolled into the study and randomized either to PiCSO Group or Control Group. If the subject is randomized to PiCSO Group, the coronary sinus (CS) will be cannulated through the femoral vein and the PiCSO Impulse Catheter will be placed in the CS. Once PiCSO Impulse Catheter is placed into CS, PiCSO treatment is started followed by stenting. The physician shall target a PiCSO treatment of 45 minutes whereas the treatment should be continued during and post stent insertion. At the end of the PiCSO treatment, the PiCSO Impulse Console is stopped and the PiCSO Impulse Catheter is removed.
15738163|NCT04958395|Diagnostic Test|FFR and d-FFR|Measure FFR and d-FFR
15738164|NCT04958382|Drug|ciprofol|intravenous infusion of ciprofol at 0.12 mg/kg, followed by 0.4-1.6 mg/kg/h for maintenance
15738165|NCT04958382|Drug|medium/long chain fat emulsion injection (C8-24Ve)|at the infusion rate of 25-30 mL/h
15738166|NCT04958369|Device|Ultrasound-guided axillary venous access|Venous access is obtained through ultrasound-guided axillary vein puncture and Seldinger technique.
15738167|NCT04958369|Device|Cephalic venous access|Venous access is obtained through cephalic vein cut-down.
15738168|NCT04958343|Procedure|pelvic reconstruction|After radical cystectomy, the pelvic reconstruction including the ligation of dorsal vascular complex and posterior reconstruction will be performed on patients.
15738169|NCT04958330|Procedure|lateral prostate capsule sparing|When resect the bladder and prostate, the lateral prostate capsule will be preserved.
15738170|NCT04958317|Other|Early exercise|Participants will exercise for 30 minutes prior to an evening meal.
15738171|NCT04958317|Other|Late exercise|Participants will exercise for 30 minutes after an evening meal.
15738172|NCT04958291|Drug|CC-99677|CC-99677
15738173|NCT04958291|Other|Placebo|Placebo
15738174|NCT04958265|Drug|Crovalimab|Crovalimab will be administered at a dose of 1000 mg intravenously (IV) (for participants weighing 40 to <100 kg) or 1500 mg IV (for participants weighing >=100 kg) on Week 1 Day 1. On Week 1 Day 2 and on Weeks 2, 3 and 4, crovalimab will be administered at a dose of 340 mg subcutaneously (SC). On Week 5 and Q4W thereafter, it will be administered at a dose of 680 mg SC (for participants weighing 40 to <100 kg) or 1020 mg SC (for participants weighing >=100 kg). Enrollment of participants weighing <40 kg will be staggered using two weight-based dose confirmation groups (Group 1 participants weighing >=20 kg to <40 kg, followed by Group 2 participants weighing >=5 kg to <20 kg). All participants will receive an initial IV loading dose, which will be followed by SC dosing at either Q2W or Q4W intervals (depending on body weight), until study completion.
15738175|NCT04958252|Drug|BI 1569912|BI 1569912
15738176|NCT04958252|Drug|Placebo|Placebo
15738177|NCT04958239|Drug|BI 765179|BI 765179
15738178|NCT04958239|Drug|Ezabenlimab|Ezabenlimab
15738179|NCT04958226|Drug|Capivasertib|Capivasertib (tablet) will be given as an intermittent schedule (4 days on/3 days off) from Cycle 1 Day 2 until discontinuation. Capivasertib will be administrated in both Part A and Part B.
15738180|NCT04958226|Drug|Midazolam|Single doses of midozalom (syrup, 1 mg) will be given on cycle 1 Days 1, 8, and 12.
15738181|NCT04958213|Drug|Dextrose prolotherapy injection|15% dextrose prolotherapy injection into the knee and 15% dextrose prolotherapy injection will be applied to the painful adhesions of the ligaments around the knee.
15738182|NCT04958213|Combination Product|conventional physical therapy|4 weeks (20 sessions) physical therapy (Hotpack, TENS and Ultrasound) and home exercise program (isometric and isotonic exercises).
15738183|NCT04958200|Behavioral|mhealth-pc for alcohol and pain|Smartphone-based intervention that includes in-person initial session and 8 video lessons, daily activities, and weekly check-ins.
15738184|NCT04958200|Behavioral|Treatment As Usual|psychoeducation on pain and alcohol use and treatment resource information
15738185|NCT04958187|Drug|ANG-3777|Arm assigned to this intervention will receive 2 mg/kg, IV
15738186|NCT04958174|Device|web-application|web application for monitoring children's development
15738305|NCT04957186|Other|Collection of postoperative information|The EORTC BR45 questionnaire will be used to gather information from patients regarding possible post-operative complications recorded via electronic patient-reported outcomes (pain, swelling, hypersensitivity etc.) as well as via the interviews with the state-registered coordinating nurse.
15755470|NCT04813718|Dietary Supplement|Placebo|Placebo
15738187|NCT04958161|Other|Exercise Therapy|Each exercise session will involve 5 to10 minutes of stretching and slow walking followed by a 30 minute stimulus phase of aerobic exercise. Exercise intensity during the stimulus phase will be prescribed based on the graded exercise test results and will be gradually increased with the goal of the participant exercising continuously for 30 minutes at 50% to 85% of symptom-limited maximum heart rate, or maintained at a level below that which causes symptomatic or silent ischemia. Following the aerobic phase of exercise, participants will complete one set of 8 to 12 repetitions of muscle-strengthening activities for all major muscle groups (legs, hips, back, abdomen, chest, shoulders, and arms). Participants will be provided with a home based aerobic exercise program. They will be encouraged to perform this home-based program twice a week on days when they are not attending the center-based program.
15738188|NCT04958148|Dietary Supplement|Salt pills|Subjects will supplement salt pills with meals.
15738189|NCT04958148|Dietary Supplement|Placebo pills|Subjects will supplement placebo pills with meals.
15738190|NCT04958135|Drug|Acoramidis|Film-coated immediate release oral tablet.
15738191|NCT04958122|Drug|Cefixime 400mg|Oral cefixime 400 mg, one capsule, twice a day for 10 days
15738192|NCT04958122|Drug|benzathine penicillin|Standard of care benzathine penicillin G, one intramuscular injection, 2.4MU
15738193|NCT04958109|Diagnostic Test|Oral Glucose Tolerance Test|Administration of a 75 gm oral glucose tolerance test
15738194|NCT04958109|Drug|Kisspeptin|Intravenous administration of kisspeptin 112-121 x 16 hours
15738195|NCT04958109|Drug|Placebo|Intravenous administration of Placebo 16 hours
15738196|NCT04958096|Device|Standard Therapeutic Deep Brain Stimulation|DBS to the standard subcortical targets (anterior limb of the internal capsule- ALIC) will be used to treat OCD
15738197|NCT04958096|Device|Cortical Stimulation for PFC|Patients enrolled in this study will have a second pair of leads placed in the prefrontal cortex (PFC) bilaterally as well the surrounding white matter tracts and stimulation will be delivered through these leads to improve OCD symptoms
15738198|NCT04958096|Device|Cortical Stimulation for ACC|Patients enrolled in this study will have a second pair of leads placed in the anterior cingulate cortex (ACC) bilaterally as well the surrounding white matter tracts and stimulation will be delivered through these leads to improve OCD symptoms
15738199|NCT04958083|Diagnostic Test|multiphase ECG-gated contrast-enhanced CT|Compared with current standard CT imaging, the dynamic CT protocol provides incremental functional information, which is potentially helpful to the individuals under study (such as early awareness for future complications and potential prediction of outcomes). Due to the nature of the acquisition, a wider R-R acquisition window will result in a higher radiation burden than a standard protocol. However, the study protocol will replace the standard routine CT image protocol as it contains both the routine anatomic information and incremental functional information. The time required for the image acquisition and associated radiation will be slightly higher; the additional information from multiple reconstructed phases will justify a slightly higher radiation burden in a usually elderly population. The estimated radiation dose for the standard imaging protocol is approximately 8 mSv. The estimated radiation dose for the modified dynamic CT image acquisition is approximately 18 mSv.
15738200|NCT04958070|Other|MPS I|MPS I, symptoms of disease onset , ERT
15738201|NCT04958057|Behavioral|SAIL|6 monthly group sessions with the study nurse with a background in prenatal care and the PI that will include each group will include preeclampsia education, coaching on stress management, resource navigation, and training in problem solving.
15738202|NCT04958044|Drug|Calcium Gluconate|Calcium electroporation
15738203|NCT04958031|Drug|CVL-871 1.0 mg|CVL-871 1.0 mg, oral (tablet), once per day for 12 weeks (stepped up-titration of dose days 1-7)
15738204|NCT04958031|Drug|CVL-871 3.0 mg|CVL-871 3.0 mg QD oral (tablet), once per day for 12 weeks (stepped up-titration of dose days 1-21)
15738205|NCT04958031|Drug|Placebo|Placebo QD, oral (tablet), once per day for 12 weeks
15738209|NCT04957992|Other|Control Infant Formula|Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age
15738210|NCT04957992|Other|Control Toddler Drink|~ 16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age
15738211|NCT04957992|Other|Experimental Infant Formula|Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age
15738212|NCT04957992|Other|Experimental Toddler Drink|~ 16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age
15738213|NCT04957979|Other|Nursing/Medical Model of Care Coordination|"No social worker on the clinic's care coordination team.
~Services provided:
~Coordinated medical care for patients
~Patient education
~Assistance in developing care plan
~Support for patient self-management
~Referrals for continuing care
~Referral to community resources
~Referral to mental health services if needed or requested
~Referral to interventional counseling for behavioral health issues"
15738214|NCT04957979|Other|Medical/Social Model of Care Coordination|"Social worker is part of the clinic's care coordination team.
~Need not be licensed as a social worker
~Must have time dedicated to care coordination for a specific clinic or clinics
~Must interact with individual patients to provide them with services
~Must interact with individual clinicians about their individual patients in care coordination
~Services provided:
~Coordinated medical care for patients
~Patient education
~Assistance in developing care plan
~Support for patient self-management
~Assistance with referrals for continuing care
~Assessment and plan to address social and resource needs including housing, transportation or financial needs; Assist patient in locating and obtaining needed community resources
~Assistance with identifying and addressing psychological/emotional issues and referrals as needed
~Interventional counseling for behavioral health issues or referrals to interventional counseling, depending on licensure"
15738215|NCT04957966|Behavioral|self-selected relaxing music|20 minutes music listening
15738339|NCT04956822|Other|Functional scores|depending on the diseases enrolled, ALS and KD chose ALS-FRS functional scores and CMT chose CMTNS2 functional scores
15738220|NCT04957940|Drug|SMOFlipid|Intravenous fish-oil-based lipid (SMOF lipid 20%) (Fresenius Kabi, Bad Homburg, Germany) emulsion supplementation to standard enteral nutrition in a dose of 100 ml/day at a rate of 12.5 ml/h over 8 h daily for 5 days.
15738221|NCT04957940|Other|0.9% saline|Receive standard enteral nutrition plus 100 ml/day 0.9% normal saline at a rate 12.5 ml/h over 8 h for 5 days
15738222|NCT04957927|Drug|Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age|Effectiveness of Montelukast Versus Intranasal Fluticasone Propionate in the Management of Allergic Rhinitis Among Children 02 to 05 Years of Age
15738223|NCT04957914|Drug|Insulin Glargine|Administered SC
15738224|NCT04957914|Drug|LY3209590|Administered SC
15738225|NCT04957901|Drug|modified BFM-95 protocol|Clinical stage system, risk stratification and treatment for pediatric mature B-NHL were according to the modified BFM-95 protocol. The tumor tissue (FFPE) and plasma samples (bone marrow or cerebrospinal fluid samples if necessary) from the newly diagnosed patients were collected and sequenced by 475 genes panel before, during and post treatment.
15738226|NCT04957888|Other|none intervention|none intervention.
15738227|NCT04957875|Device|emergency endoscopic therapy|When cirrhotic patients presented with AVB to the emergency department, emergency physicians consulted gastroenterologists on duty to assess the patient for suitability for endoscopy, usually after initial stabilization. Performance of endoscopy and its timing was at the discretion of the gastroenterologist on call. Therapeutic endoscopy for AVB was performed within 24 hours after consultation by an experienced attending endoscopist, using standard forward-viewing upper gastrointestinal video endoscopes at individual centers. Written informed consent for endoscopy was obtained before each procedure. The standard of care at all hospitals was to administer a vasoactive agent and antibiotics upon the patient's presentation. Packed red blood cells were transfused at the discretion of the attending gastroenterologist.
15738228|NCT04957862|Procedure|Robotic Assisted Evacuation|Perform robotic minimally invasive puncture and aspiration. On the one hand, it reduces the pressure of hematoma on the peripheral functional fiber bundles, while minimizing iatrogenic damage; on the other hand, it reduces the killing of peripheral nerve cells by the deposition of hemosiderin after the disintegration of red blood cells.
15738229|NCT04957849|Procedure|The Neuroendoscopic, Trans-occipital Approach Evacuation of Acute Hypertensive Cerebral Hemmorrhage Combined Low-drainage Surgery|The Neuroendoscopic, Trans-occipital Approach Evacuation of Acute Hypertensive Cerebral Hemmorrhage Combined Low-drainage Surgery
15738230|NCT04957849|Procedure|Endoscopic Evacuation of Acute Hypertensive Intracerebral Hemorrhage via Trans-frontal keyhole approach|Endoscopic Evacuation of Acute Hypertensive Intracerebral Hemorrhage via Trans-frontal keyhole approach
15738231|NCT04957836|Other|reversal with sugammadex|reversal with sugammadex for immediate extubation in the operating room
15738232|NCT04957810|Behavioral|WeChat Mini Program|Through the WeChat applet, it provides services such as visit content configuration, self-image configuration, self-image measurement configuration, and visit reminders.
15738233|NCT04957797|Procedure|round tunnel|reamed with round tunnel
15738234|NCT04957797|Procedure|flat tunnel|reamed with flat tunnel
15738235|NCT04957784|Other|questionnaire survey|Understand the current situation of hypertension management in a poor county in Shanxi Province through questionnaire surveys, and explore the factors that affect patients' blood pressure control based on local conditions
15738236|NCT04957771|Other|Supervise and guide regular exercise|Aerobic exercise, evaluated by cardiopulmonary exercise test, 3-5 times a week
15738237|NCT04957758|Drug|OC-01 (varenicline) nasal spray 1.2 mg/ml|OC-01
15738238|NCT04957758|Drug|Placebo (vehicle) nasal spray|Placebo (vehicle)
15738239|NCT04957745|Other|Visual confusion|We will show peripheral target images on a background motion in a stereoscopic display. For the binocular visual confusion condition, the target peripheral image will be displayed on only one eye. For unilateral and bilateral monocular visual confusion conditions, the half-transparent peripheral image will be displayed on only one eye and both eyes, respectively.
15738240|NCT04957732|Device|Standard of Care (SoC)|SoC consisted of irrigation with normal saline, using the same proprietary abscess irrigation tip as the Irrisept arm. SoC was used at the initial visit and at each subsequent 48-hour visit interval until abscess healing.
15738241|NCT04957732|Device|Irrisept Delivery System|Irrisept is a manual, self-contained irrigation device capable of producing 7-8 psi of pressure for effective wound cleansing and irrigation. Irrisept contents include the Chlorhexidine Gluconate (CHG) solution, a 450 mL bottle, and Irriprobe applicator or an abscess irrigation tip. The bottle design allows users to control the pressure of the solution through manual bottle compression. The device had an option for use with an Irriprobe applicator or an abscess irrigation tip. Irrisept was used at the initial visit and at each subsequent 48-hour visit interval until abscess healing.
15738306|NCT04957186|Other|Analysis of postoperative information collected from patients|All post-operative complications recorded via electronic patient-reported outcomes (pain, swelling, hypersensitivity etc.) as well as via the interviews with the state-registered coordinating nurse will be analyzed with the aim of proposing an appropriate care pathway.
15739122|NCT04949867|Drug|Glucagon|Glucagon is filled in the pump and given automatically in case of hypoglycemia or pending hypoglycemia.
15738242|NCT04957719|Combination Product|Selatogrel|"Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. Selatogrel will be administered as a liquid formulation in a sealed prefilled syringe in an autoinjector forming an integral ready-to-use, single-dose drug delivery system.
~Participants will self-administer 16 mg of selatogrel subcutaneously with the autoinjector upon occurrence of symptoms suggestive of an acute myocardial infarction. Self-administration encompasses the use of the autoinjector by another person (e.g., partner, close relative, friend, caregiver) who may be called for help during the emergency situation of a suspected AMI."
15738243|NCT04957719|Combination Product|Placebo|"Placebo will be administered as a liquid formulation in a sealed prefilled syringe in an autoinjector forming an integral ready-to-use, single-dose drug delivery system.
~Participants will self-administer placebo subcutaneously with the autoinjector upon occurrence of symptoms suggestive of an acute myocardial infarction. Self-administration encompasses the use of the autoinjector by another person (e.g., partner, close relative, friend, caregiver) who may be called for help during the emergency situation of a suspected AMI."
15738244|NCT04957706|Diagnostic Test|anterior drawer test at 90° of hip flexion|anterior drawer test at 90° of hip flexion
15738245|NCT04957706|Diagnostic Test|Lachman test|Lachman test
15738246|NCT04957706|Diagnostic Test|anterior drawer test|anterior drawer test
15738247|NCT04957706|Diagnostic Test|pivot-shift test|pivot-shift test
15738248|NCT04957693|Behavioral|vegan diet and lifestyle changes|vegan diet and lifestyle changes
15738249|NCT04957680|Behavioral|CCBT|computer-based treatment program for depressed adolescents
15738250|NCT04957654|Other|VST with collagen plug soaked in blood|-A sub mucoperiosteal tunnel will be created, a membrane shield will be trimmed to fit the facial wall of the socket and introduced through the tunnel lying over the facial bone plate, and the facial gap will be filled with collagen plug soaked in blood
15738251|NCT04957654|Other|VST with Allograft Demineralized bone matrix Grafton|-A sub mucoperiosteal tunnel will be created, a membrane shield will be trimmed to fit the facial wall of the socket and introduced through the tunnel lying over the facial bone plate, and the facial gap will be filled with Allograft Demineralized bone matrix Grafton
15738252|NCT04957654|Other|VST with a particulate bone graft composed of two thirds autogenous cortical chips harvested from the surgical site and one third of bovine deprotinzed particles|-A sub mucoperiosteal tunnel will be created, a membrane shield will be trimmed to fit the facial wall of the socket and introduced through the tunnel lying over the facial bone plate, and the facial gap will be filled with a particulate bone graft composed of two thirds autogenous cortical chips harvested from the surgical site and one third of bovine deprotinzed particles
15738253|NCT04957628|Behavioral|Harmful alcohol use treatment|Patients identified through routine hospital screening as having a potentially harmful alcohol use (AUDIT-C 4-6 points (men) / 3-5 points (women) will receive information about the possible harmful effects of their drinking and will be advised to reduce their consumption. Patients identified with more excessive drinking patterns (AUDIT-C > 6 (men) / > 5 (women) will be assessed with blood sample analysis of relevant alcohol biomarkers, psychological assessments for alcohol addiction and withdrawal symptoms, and if necessary referral to alcohol addiction treatment. Patients with severe withdrawal symptoms will be put in CIWA-Ar observation.
15738254|NCT04957628|Behavioral|Non-prescribed psychoactive medicinal use treatment|Patients with prescription on psychoactive medicinal drugs are pharmacologically assessed using serum sample analysis. Patients identified with discrepancy in prescribed doses and serum concentrations will have doses adjusted, or be referred to addiction treatment. Patients identified with psychoactive medicinal drugs other than those prescribed will be advised to quit those medications, or be referred to addiction treatment.
15738255|NCT04957615|Biological|Nivolumab|Given IV
15738257|NCT04957589|Dietary Supplement|Very Low Calorie Diet|"A dietary intervention consisting of four meals (provided by LighterLife®), totaling approximately 600kcal/day (each meal comprising approximately 150kcal/day). Participants are provided with a choice of one of six meal protocols, which consist of a pre-set combination of meals that arrive at approximately 52g protein, more than 15g fibre and less than 20g sugar per day."
15738258|NCT04957589|Dietary Supplement|Protein supplementation|200kcal/day whey protein (approximately 38g protein), provided to the intervention arm.
15738259|NCT04957589|Other|High Intensity Interval Training|The HIIT training will consist of a five-exercise approach across three movements (star jumps, standing squats, on-the-spot-sprinting, standing squats and star jumps), which are collectively described as a cycle in this context. Each exercise is performed for 60 seconds with a 90 seconds recovery period. Each training session will begin with a two minute warm-up and cooldown (on-the-spot-jogging) followed by five minutes of static stretching. Volunteers would aim to exceed the initial number of star jumps and standing squats in the subsequent attempt per cycle. A total of three training sessions per week are to be completed, preferably non-consecutive but may be consecutive on no more than two training sessions per week. Progression is through a gradual increase in volume (repetitions of star jumps and standing squats) on a per-session basis.
15738260|NCT04957576|Behavioral|Visuo-tactile stimulation|The patient will place both hands on a table in front of him/her, seeing only the left one disown. A visuo-tactile stimulation will be done, with the right (out of view, but perceiving the tactile stimulation) and left (in full view, but with somato-sensory deficits, therefore not feeling the stimulation) hands touched with a paintbrush for five minutes.
15738261|NCT04957563|Behavioral|olfactory rehabilitation|treatment for improve olfactory function
15738262|NCT04957550|Drug|SHR0302 tablets、Placebo|SHR0302 tablets dose 1 for 48 weeks
15738263|NCT04957550|Drug|SHR0302 tablets、Placebo|SHR0302 tablets dose 2 for 48 weeks
15738264|NCT04957550|Drug|Placebo|SHR0302 tablets blank preparation for 24 weeks then SHR0302 tablets dose 1/dose 2 for 24 weeks
15738307|NCT04957173|Other|Lifestyle intervention|"The intervention includes a total of 15 virtual meetings and aims to achieve a weight loss of 0.8 to 1% of the initial weight per week.
~This will include 3 successive phases:
~A significant calorie restriction (800 kcal / day) for a period of 4 weeks;
~A moderate calorie restriction (minimum deficit of 500 kcal / day) for a period of 4 weeks;
~A maintenance phase of weight loss for 16 weeks."
15738308|NCT04957147|Other|12 months of guideline-directed heart failure therapy|Standard guideline-directed heart failure drug +/- device therapy
15738265|NCT04957537|Behavioral|semantic therapy and semantic re-education|"Patients will be followed over two periods Phase A (randomized, 6 to 8 weeks) - Phase B (5 weeks).
~Phase A : Baseline Phase A, which constitutes the control period of semantic therapy, will be composed of lexico-phonological training exercises (Piroux-Davous, 2018). This phase will last 6 to 8 weeks (i.e. 18 to 24 sessions) depending on the randomisation, at the rate of 3 speech therapy sessions of 45 minutes per week.
~Phase B : Semantic re-education The sessions will consist of training based on the analysis of semantic traits (Coustaut, 2019). This phase will last 5 weeks (i.e. 15 sessions), at the rate of 3 speech therapy sessions of 45 minutes per week.
~In accordance with the application of the SCED methodology, repeated measurements will be carried out every second session during phases A and B. They will consist of proposing the oral naming task (lasting 10 minutes)."
15738266|NCT04957524|Device|iStim TENS unit and Transvaginal Probe|"iStim TENS unit and Transvaginal Probe are both commercially available products. TENS units work by delivering small electrical impulses through electrodes either attached to the skin or through a transvaginal probe.
~iStim transvaginal probe will be inserted vaginally to provide transvaginal electrical stimulation."
15738267|NCT04957498|Behavioral|Guided Self-Help for Family Based Treatment|A online website provided to parents containing information learned in Family Based Treatment and up to 12 coaching sessions with a therapist.
15738268|NCT04957498|Behavioral|Family Based Treatment|Standard Family Based Treatment provided for up to 15 sessions.
15738269|NCT04957485|Biological|JYNNEOS + TPOXX|biologic + drig
15738270|NCT04957485|Biological|JYNNEOS + TPOXX PLACEBO|biologic + drug placebo
15738271|NCT04957472|Device|fabian HFO, fabian +nCPAP evolution and fabian Therapy evolution with PRICO function|24 hours of automated control of FiO2
15738272|NCT04957472|Other|Manual Control|24 hours of manual control of FiO2
15738273|NCT04957459|Other|No intervention|No intervention
15738274|NCT04957446|Device|Sculptra Aesthetic|Injectable implant containing microparticles of poly-L-lactic acid (PLLA)
15738275|NCT04957446|Other|Placebo|Saline solution
15738276|NCT04957433|Diagnostic Test|Blood Specimen|Blood and Sputum Specimen Samples
15738277|NCT04957420|Drug|Neupro|Rotigotine Patches
15738278|NCT04957407|Other|pepsinogen|diagnostic value of pepsinogen for severe atrophy and gastric cancer
15738279|NCT04957394|Behavioral|Family Partner|"The Family Partner intervention is based on well-known elements for preventing child abuse and neglect, such as 1) high intensity intervention with home visitations, 2) coordination of services, 3) an ecological perspective, 4) parental guidance, and 5) an emphasis on a therapeutic relationship with parents to create trust, change and agency.
~Family Partners must have relevant professional background and education, such as social work, child welfare services and other health/welfare occupations. They must have a personal attitude for relation-based service delivery in a home-setting, a long work experience and in-depth knowledge of municipal welfare services.
~Each practitioner will follow five families. The estimated duration of the intervention is 12 months, but might go over longer stretches of time if it is considered beneficial for the families. The minimum duration of the intervention is 3 months."
15738280|NCT04957381|Behavioral|Group exercises|Group exercises including aerobic, resistance and stretching exercise. Once a week for 8-12 weeks.
15738281|NCT04957368|Drug|Nitrous Oxide 99 %|Nitrous oxide will be administered at an inspiratory concentration of 50% with concurrent intravenous saline (100ml) for one hour.
15738282|NCT04957368|Drug|Oxygen + Midazolam|Oxygen will be administered at 50% with intravenous midazolam (0.02mg/kg in 100ml) for one hour
15738283|NCT04957355|Device|Neuromuscular electrical stimulation (NMES) or Functional electrical stimulation (FES)|"Stance and Walk-Perturbation Training Protocol ActiveStep and Surefooted Protocol: Perturbation training protocol with and without FES Participants will be asked to perform a postural disturbance protocol in the stance position and walk in the form of 7 slips and 7 trips with two retention trials after the training using the ActiveStep treadmill system while fitted in a safety harness. All perturbations will be delivered at each participant's comfortable walking speed. Similar slip and trip training in walking will be conducted on the surefooted platform with and without FES.
~Gait Training Protocol and Surefooted protocol Participants will be asked to perform a 10m walking test (walking for a distance of 45 feet) in a laboratory environment six times (three times with and without FES) and in an outdoor environment located in the parking lot of the Applied Health Science building (1919 W. Taylor St., Chicago, IL)"
15738284|NCT04957342|Biological|amnion-chorion membrane|allograft to be placed on palate
15738285|NCT04957342|Procedure|Sutures|Sutures (e.g. interrupted, crisscross compression) to be placed on palate
15738286|NCT04957329|Drug|Xalatan|Eye drop
15738287|NCT04957329|Drug|Monoprost|Eye drop
15738288|NCT04957316|Device|Triple-effect blood purification filter|Blood purification using the oXiris filter to remove endotoxin, cytokines, and uremic toxins.
15738289|NCT04957303|Device|sublingual microcirculation video recording|The sublingual microcirculation videos were recorded by video microscope
15738290|NCT04957290|Drug|NOX66|NOX66 800 mg daily (400 mg suppository twice daily [BID]).
15738291|NCT04957290|Drug|NOX66|NOX66 1200 mg daily (600 mg suppository BID).
15738292|NCT04957290|Drug|NOX66|NOX66 1600 mg daily (800 mg suppository BID).
15738293|NCT04957290|Drug|NOX66|NOX66 2400 mg daily (1200 mg suppository BID).
15738294|NCT04957290|Drug|NOX66|NOX66 RP2D
15738295|NCT04957290|Radiation|EBRT|The dose levels of EBRT will be either 8 Gy as a single fraction, or 20/25 Gy as 5 fractions given over 5 to 10 days.
15738296|NCT04957277|Other|load modulation|Adding body weight (BW) up to 20% BW and subtracting body weight down to -20% BW
15738297|NCT04957251|Procedure|anterior approach to the hip|anterior hip hemiarthroplasty
15738298|NCT04957251|Procedure|posterior approach to the hip|posterior hip hemiarthroplasty
15738299|NCT04957238|Other|ARBORea decision-making tool|Online ARBORea decision-making tool will guide the use of physical restraints in ICU patients based on objective information on neurological status, level of equipment related to critical illness, and patient's family presence and involvement in patient's surveillance.
15738300|NCT04957225|Behavioral|MIRAA (Multimodal Intensive Rehabilitation of Aphasia and Apraxia of speech)|Multimodal intensive treatment of aphasia and AOS
15738301|NCT04957212|Drug|Trastuzumab|An initial dose of 8 mg/kg, followed by 6 mg/kg every 3-weeks
15738302|NCT04957212|Drug|Pertuzumab|An initial dose of 840 mg, followed by 420 mg every 3-weeks
15738309|NCT04957134|Device|Electro-acupuncture with lifestyle intervention|"The acupoints of electro-acupuncture will be selected as Zusanli ,Sanyinjiao ,Zhongwan , Tianshu , Shuifen , Daheng ,Daimai , Shuidao ,Huaroumen and Fujie . We will deliver electrical stimulation with dense-disperse waves at 50 Hz and 10 V through the electrical acupuncture stimulation instrument to the abdominal points. The bodily needles will be retained for 30 minutes . Electro-acupuncture treatment will be applied 3 times a week, once every other day, for 8 consecutive weeks.
~Lifestyle intervention will help participants establish healthy living habits. The exercises will be taken for 35~40 minutes everyday, 7 times a week, for 8 weeks. All patients will be instructed to follow a good living habits which will last 12 weeks including the treatment period of 8 weeks and the follow-up period of 4 weeks."
15738310|NCT04957134|Device|Sham electro-acupuncture with lifestyle intervention|"The acupoints of sham electro-acupuncture will be selected as nonacupoints .A superficial skin penetration (2-3 mm in depth) will be performed at nonacupoints , without needle manipulation for De qi. The internal output power cord of the electrical acupuncture stimulation instrument will be interrupted. The bodily needles will be retained for 30 minutes . Sham acupuncture treatment will be applied 3 times a week, once every other day, for 8 consecutive weeks.
~Lifestyle intervention will help participants establish healthy living habits. The exercises will be taken for 35~40 minutes everyday, 7 times a week, for 8 weeks. All patients will be instructed to follow a good living habits which will last 12 weeks including the treatment period of 8 weeks and the follow-up period of 4 weeks."
15738311|NCT04957121|Other|on-hours|"If the begin time of anesthesia was between 8:00 to 17:59, it was defined as on-hours."
15738312|NCT04957121|Other|off-hours|"If the start time of anesthesia was between 18:00 to 7:59 or the end time of anesthesia was later than 20:00, it was defined as off-hours."
15738313|NCT04957108|Other|Device identification using Xray.|PMIDa and CRMD-f applications were used to identify CIED
15738316|NCT04957082|Behavioral|Culturally Targeted SARS-CoV-2 Communication|SARS-CoV-2 video tutorial includes a one minute video based messaging adjunct meant to enact a culturally targeted framing of health information presented to African Americans.
15738317|NCT04957082|Behavioral|General SARS-CoV-2 Communication|SARS-CoV-2 video tutorial is for general consumption and does not include culturally targeted information
15738318|NCT04957069|Procedure|fixation|double row fixation with 3-4 wire anchors
15738319|NCT04957069|Procedure|primary repair|end-to-end repair
15738320|NCT04957056|Procedure|Hospitalization|Hospitalization
15738321|NCT04957030|Diagnostic Test|ULDCT group|underwent ultralow-dose chest CT
15738322|NCT04957017|Behavioral|Training|"After the data was collected, the women in the intervention group were trained on Hand-Washing and Nutrition during the COVID-19 period. The training on hand-washing and nutrition was given using the Hand-Washing and Nutrition Training Guide prepared by the researchers, and the Hand-Washing and Nutrition Training Manual covering the content of the training, was distributed to the women at the end of the training"
15738323|NCT04957004|Device|CPAP|CPAP ventilator was worn at nigh
15738324|NCT04956978|Other|Patient Decision Support Tool|Patient decision support tool is a web based educational material that informs a patient on the risk and benefits of oral anticoagulation. In addition, such a tool aims to assess patient values and preferences in the decision making process for oral anticoagulation for stroke reduction.
15738325|NCT04956965|Radiation|Cardiac electro-mapping|Perform an high-resolution three-dimensional maps of cardiac electrical activity using EnSite Precision system.
15738326|NCT04956952|Device|EECP|1 hour of treatment with EECP
15738327|NCT04956939|Drug|Low dose levodopa|Low frequency is defined as ≤ 3 LD doses a day
15738328|NCT04956939|Drug|High dose levodopa|High frequency dosage is defined as ≥ 5 LD doses per day
15738329|NCT04956926|Drug|JS201|JS201 is administered intravenously Q3W at the corresponding dose.
15738330|NCT04956913|Device|Mac Grath|Patients of this group were intubated using Mac Gath videolaryngoscope
15738331|NCT04956913|Device|Macintosh|Patients of this group were intubated using the Macintosh Laryngoscope
15738332|NCT04956900|Drug|Aurase Wound gel|Aurase Wound Gel is reconstituted from Aurase Component A (a hydrogel) and Aurase Component B (stabilised solutions of Aurase enzyme). By diluting different strengths of Aurase Component B with Component A, specific concentrations of Aurase Wound Gels with differing Aurase contents are yielded.
15738333|NCT04956887|Behavioral|AKL-T01|The study intervention, AKL-T01 (Akili Interactive), is a digital, app-based intervention designed to target and improve cognition through an engaging video game-based software experience delivered on an iPad.
15738334|NCT04956887|Other|Control Group|Patients assigned to the control group will receive no intervention, as is typical for those with Covid-19 with respect to cognitive functioning
15738335|NCT04956874|Behavioral|FL-REACH|The FL REACH intervention is a 6-session intervention designed to facilitate transition to care following delivery of a memory disorders diagnosis by a MDC team. The intervention focused on an approach that used a toolbox of strategies to tailor skills-based learning, knowledge transmission, and self-care strategies to dementia caregivers. This pilot study focuses on adapting the established REACH II intervention for translation to the clinical setting, with a focus not only on implementation of the key components of the program, but also on feasibility and sustainability. This is part of a stepped-care model that is being developed at the AdventHealth-Orlando MDC. Caregivers of patients will be referred to the FL REACH intervention for foundational training and skills-development.
15738336|NCT04956861|Behavioral|Individualized Targeted Sleep|The investigators will employ an 8-week individualized targeted sleep intervention. Individualized targeted interventions have the advantage of improving adherence, reducing attrition, and making the strategy personally meaningful.
15738337|NCT04956848|Device|iDAScore®|Images of all the embryos reaching at least developmental stage of 3BB will be analyzed by iDAScore®. The embryo with the highest iDAScore® will be proposed for transfer.
15738338|NCT04956822|Other|Basic information|Demographic data registration, medical history taking, physical examination. Electrocardiogram. Pulmonary function tests.
15739167|NCT04949464|Other|Questionnaire Administration|Ancillary studies
15738340|NCT04956822|Device|MINUX|MUNIX examination was performed on all subjects. A total of eight bilaterally symmetrical muscles were selected, bilateral abductor little finger or abductor pollicis brevis, bilateral biceps or deltoid muscles, bilateral tibialis anterior muscles, and bilateral femurs. For quadriceps, choose a muscle with less muscle atrophy.
15738343|NCT04956796|Behavioral|Airway Video Library Training|A video airway library consisting of real-life clinical videos of laryngoscopy and endotracheal intubation was developed by the study investigators. This library consists of video clips of normal and easy airways, pediatric airways as well as pathological or difficult airways that is devoid of patient identifying data. The participants of the study group will be exposed to the video library by two learning sessions. Each learning session consists of 1 hour of interactive & immersive learning of 30 airway videos. At the end of the session, the participants will be oriented to the airway and identify key airway structures, learn to troubleshoot and navigate difficult anatomy, optimize visualization, and use accessory airway equipment.
15738344|NCT04956796|Behavioral|Conventional Airway Training|The endotracheal intubation training Anesthesiology students currently receive routinely as part of their education.
15738345|NCT04956770|Procedure|Implantation surgery|"The intervention involves the implantation of:
~a neurostimulator: the Activa® RC from Medtronic
~a stimulation electrode paddle array: the Specify™ SureScan® 5-6-5 from Medtronic"
15738346|NCT04956757|Other|Exercise Intervention|Scapula retraction exercises at varying shoulder abduction angles will be applied
15738347|NCT04956744|Biological|IMS001|IMS001 is a human embryonic cell derived (hESC) mesenchymal stem cell (MSC).
15738348|NCT04956731|Other|Pharmacist Provision of Medication Abortion|Pharmacists providing start to finish medication abortions
15738351|NCT04956705|Dietary Supplement|Vitamin D and calcium|Either as tablets, droplets or sprays. Preferably daily doses of 20 µg of vitamin D and 800-1000 mg of calcium as recommended.
15738359|NCT04956679|Diagnostic Test|carbon 13 breath test|Patients with positive Helicobacter pylori infection were determined by carbon 13 breath test ,The diagnosis and treatment of positive patients were followed up without other intervention.
15738360|NCT04956666|Drug|Lyophilized S95014|"Each patient will be administrated, over 1 to 2 hours, every 2 weeks Lyophilized S95014 intravenously at the dose of 1000, 2000 or 2500U/m2, as per investigator's judgement.
~In total, 9 infusions of lyophilized S95014 will be administrated (at week 7, 9, 11, 15, 17, 19, 23, 25 and 27).Patients will receive other backbone chemotherapy agents as per ALL-MB 2015."
15738361|NCT04956653|Other|Without additional intervention|Only patients' information was collected
15738362|NCT04956640|Drug|LY3537982|Oral
15738363|NCT04956640|Drug|Abemaciclib|Oral
15738364|NCT04956640|Drug|Erlotinib|Oral
15738365|NCT04956640|Drug|Sintilimab|Intravenous
15738366|NCT04956640|Drug|Temuterkib|Oral
15738367|NCT04956640|Drug|LY3295668|Oral
15738368|NCT04956640|Drug|Cetuximab|Intravenous
15738369|NCT04956627|Drug|BMS-986166|Specified dose on specified days
15738370|NCT04956627|Drug|Itraconazole|Specified dose on specified days
15738371|NCT04956627|Drug|Extended Phenytoin Sodium|Specified dose on specified days
15738372|NCT04956627|Drug|Gemfibrozil|Specified dose on specified days
15738373|NCT04956614|Device|immobilisation duration|immobilisation duration of 2,4,6 week after suture of Achilles tendon
15738374|NCT04956601|Radiation|vaginal brachytherapy/pelvic external beam radiotherapy|high-dose-rate vaginal brachytherapy; pelvic external beam radiotherapy
15738375|NCT04956588|Combination Product|surgical robot|The surgical robot completed the screw placement according to the surgical plan, and the researchers closely monitored the screw placement process.
15738376|NCT04956588|Combination Product|controlled approach|The screw placement was performed using a controlled approach according to the surgical plan.
15738377|NCT04956575|Biological|mRNA-1010|Sterile liquid for injection
15738378|NCT04956575|Biological|Placebo|0.9% sodium chloride solution for injection
15738379|NCT04956549|Behavioral|Physical activity program|Supervised group sessions will be held twice per week for approximately 52 weeks. Each physical activity session will last slightly approximately 80 minutes and will consist of aerobic, strength, flexibility, and balance training. The 80 minutes of activity consists of a 5 minute warm-up, 45 minutes of aerobic training, 15 minutes of strength training, 10 minutes of balance training, and a 5 minute cool-down. The physical activity group will target 150 minutes of moderate to vigorous aerobic physical activity and two days of strength training, consistent with the current physical activity recommendations.
15738380|NCT04956549|Behavioral|Successful Aging|The successful aging group will be based on a low-intensity activity program and a healthy aging educational component. Sessions will be approximately 60 minutes in duration and will occur once per week for the first 6 months and then every other week for the remainder 6 months of the study. The physical activities will include stretching, balance training, flexibility, relaxation, and practicing activities of daily living. The successful aging education component will cover topics including avoiding scams, fall prevention, living wills, and dementia awareness.
15739168|NCT04949464|Behavioral|Smoking Cessation Intervention|Use Positively Smoke Free - Mobile
15738381|NCT04956536|Other|Demographic data and MRI images were extracted and analyzed|Demographic data and MRI images were extracted and analyzed. Related factors for anterior tibial subluxation were examined in anterior cruciate ligament-injured patients.
15738382|NCT04956510|Other|Evaluation|health status and quality of life were evaluated
15738383|NCT04956497|Device|extracorporeal membrane oxygenation (ECMO)|ECMO under ongoing cardiopulmonary resuscitation (eCPR) in patients with refractory cardiac arrest
15738384|NCT04956484|Biological|Belimumab|Belimumab 10 mg/kg plus standard therapy
15738385|NCT04956484|Drug|Standard of care|Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.
15738386|NCT04956471|Other|interview|A sample method: convenience sampling, selecting A 3 armour hospital between September 2019 and January 2020 neurology hospital patients with swallowing disorder after stroke, about 15 cases.
15738387|NCT04956458|Procedure|Lumbar motion style acupuncture treatment|Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle created in Jaseng Hospital. This treatment involves patients with musculoskeletal pain to move the part of their body actively during acupuncture treatment under physicians' observation
15738388|NCT04956458|Procedure|Korean medical treatment|acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine
15738389|NCT04956432|Drug|SHR4640|SHR4640 Dose 1 ,tablets, QD
15738390|NCT04956432|Drug|Allopurinol|Allopurinol 300mg, tablets, QD
15738391|NCT04956419|Drug|SHR8008 capsule|once daily for 2 days(Day 1 and Day 2),oral
15738392|NCT04956419|Drug|Fluconazole capsule|once daily for 2 days(Every 72 hours) ,oral
15738393|NCT04956406|Behavioral|Motivational Interviewing for Adult Kidney Transplant Recipients|Motivational interviewing with individual sessions are planned to be conducted 3 times. Planned motivational interviews will be implemented the intervention group who are within 3th month, 4th month, 5th month and 6th month. Motivational interviewing will planned last 15-30 minutes with an interval of 10 days. The first interview will be performed face-to-face at the transplant outpatient clinic and the second and third ones will be phone interviews
15738394|NCT04956406|Other|Routine care|The control group will be provided with routine care( face-to-face care standard training) by the nurse educator at the transplant outpatient clinic.
15738395|NCT04956393|Behavioral|Immediate 8-Week SOAR Program|"This is an 8-week, virtually delivered, exercise-based, knee health program delivered to knee injury participants by trained physiotherapists. The program has 3 components:
~Knee Camp: This includes an interactive education session about knee health, 1:1 knee exam, and 1:1 counseling session to identify Specific, Measurable, Attainable, Relevant, and Time-bound (SMART) weekly home-based exercise-therapy and physical activity goals, Participants are asked to wear Fitbit's® 24-hours/day.
~Weekly Home-based Exercise-Therapy and Physical Activity, with Tracking: At home, participants work to meet their exercise-therapy and physical activity goals. Exercises are tracked with an online bespoke form and activity, with a Fitbit.
~Weekly PT-guided Exercise-Therapy and Physical Activity Counseling Sessions: Each week participants will attend a 1:1 virtual physiotherapist counseling session to modify SMART goals and have the option to attend a group exercise class."
15738396|NCT04956393|Behavioral|Delayed 8-Week SOAR Program|"This is an 8-week, virtually delivered, exercise-based, knee health program delivered to knee injury participants by trained physiotherapists. The program has 3 components:
~Knee Camp: This includes an interactive education session about knee health, 1:1 knee exam, and 1:1 counseling session to identify Specific, Measurable, Attainable, Relevant, and Time-bound (SMART) weekly home-based exercise-therapy and physical activity goals, Participants are asked to wear Fitbit's® 24-hours/day.
~Weekly Home-based Exercise-Therapy and Physical Activity, with Tracking: At home, participants work to meet their exercise-therapy and physical activity goals. Exercises are tracked with an online bespoke form and activity, with a Fitbit.
~Weekly PT-guided Exercise-Therapy and Physical Activity Counseling Sessions: Each week participants will attend a 1:1 virtual physiotherapist counseling session to modify SMART goals and have the option to attend a group exercise class."
15738397|NCT04956380|Other|Self-administered Triage|Self-assessment including a self-administered patient joint count and a self-administered Early Inflammatory Arthritis Detection Tool
15738398|NCT04956367|Procedure|Ablative fractional carbon dioxide laser combined with autologous platelet-rich plasma|Carbon dioxide laser (Smaxel.878.4810) was FDA-approved device used in dermatology practice. PRP was described as having growth factors to be used to promote healing.
15738399|NCT04956367|Device|CO2 laser with PRP|CO2 laser with PRP
15738400|NCT04956367|Device|CO2 laser with placebo|CO2 laser with placebo
15738430|NCT04956120|Device|Citrate Dialysate|Dialysate is generated during dialysate from two concentrates (acid concentrate and bicarbonate concentrate) mixed with treated water. When used, citrate is provided in the acid concentrate. The acid concentrate with citrate is approved for this use by the FDA and will be used according to standard procedures without altered dialysis machine settings.
15738724|NCT04953377|Behavioral|PFMT educational intervention|an educational intervention to learn about the pelvic floor and how to train it
15738403|NCT04956341|Device|Auricular acupuncture|Auricular acupuncture treatments will be utilizing ASP needles. The needles will stay in and fall out on their own (usually 3-10 days). For some patients who are acupuncture naïve, Seirin 15mm needles will be placed and allowed to remain for 45 minutes. This option will be provided to all subjects for their first treatment. Auricular acupuncture treatment possible locations will be as defined as: Master Cerebral/Prefrontal cortex, Amygdala, Hippocampus, Hypothalamus, Point Zero, Shen Men, Insomnia 1,Insomnia 2 OR Prefrontal Cortex, Reticular formation, Pineal gland, Hypothalamus, Point zero. In acupuncture parlance, the patient will be treated with ATP plus sleep I on first visit, then the acupuncturist will continue to use that treatment for each subsequent visit with the potential to add ATP plus sleep II. Both ears will be treated unless the patient requests that one be left open. The acupuncturist may use sleep I in one ear and sleep II in the other.
15738404|NCT04956341|Other|Standard treatment|Standard treatment from Primary Care Manager (PCM) or Mental Health or both
15738405|NCT04956328|Drug|Obeticholic Acid Tablets|Obeticholic Acid：Once a day (QD) by mouth (PO).
15738406|NCT04956328|Drug|UDCA|UDCA：continue prestudy dose
15738407|NCT04956328|Drug|Placebo|Placebo
15738408|NCT04956315|Diagnostic Test|Side-to-side difference (reproducibility)|The experienced examiner performed tests on 20 healthy subjects
15738409|NCT04956315|Diagnostic Test|Side-to-side difference (availability)|Two examiners performed the test on one healthy subject with both devices for ten consecutive days.
15738410|NCT04956315|Diagnostic Test|Side-to-side difference (Accuracy)|200 ACL rupture and 200 healthy subjects were recruited as contrast to compare the accuracy of the devices in diagnosing ACL rupture.
15738411|NCT04956302|Drug|Bortezomib|Given SC
15738412|NCT04956302|Drug|Daratumumab and Hyaluronidase-fihj|Given SC
15738413|NCT04956302|Drug|Dexamethasone|Given PO or IV
15738414|NCT04956302|Drug|Panobinostat Lactate|Given PO
15738415|NCT04956289|Drug|Viltolarsen|Received during weekly intravenous infusions
15738416|NCT04956276|Drug|ALXN1830|Administered as an SC infusion.
15738417|NCT04956276|Drug|Placebo|Administered as an SC infusion.
15738418|NCT04956263|Drug|YG1699|"YG1699 is a novel investigational dual inhibitor of sodium-dependent glucose cotransporters, SGLT1 and SGLT2, indicated as an adjunct to diet and exercise to improve glycemic control and weight loss in adults with T2DM. A subsequent indication will be developed for YG1699 to improve glycemic control in adults with T1DM.
~The proposed dosage form is a yellow, film-coated tablet for oral administration. The proposed tablet strengths for the current clinical research are 5 mg and 25 mg. The tablets are packaged in high-density polyethylene (HDPE) bottles with HDPE caps and desiccant inserters. Each HDPE bottle contains 30 tablets of drug product.
~The study drug YG1699 is manufactured by Youngene Therapeutics Inc., Ltd., China."
15738419|NCT04956263|Drug|Dapagliflozin|Farxiga® is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. Faxiga® is available as a film-coated tablet for oral administration containing the equivalent of 5 mg dapagliflozin as dapagliflozin propanediol and the following inactive ingredients: microcrystalline cellulose, anhydrous lactose, crospovidone, silicon dioxide, and magnesium stearate. In addition, the film coating contains the following inactive ingredients: polyvinyl alcohol, titanium dioxide, polyethylene glycol, talc, and yellow iron oxide.
15738420|NCT04956250|Other|Traffic Calming Curbs|Temporary curb extensions, placed at intersections.
15738421|NCT04956250|Other|In-Street Pedestrian Sign|Yield sign placed in middle of road at intersection.
15738424|NCT04956211|Procedure|Periodontal therapy|Patients will receive a standard regimen of scaling and root planing of the root surfaces under local analgesia (depending on the severity in one or two sessions within 2 days) with curettes and ultrasonic instruments.
15738425|NCT04956172|Device|NeuroCatch Platform 2|To elicit the ERP components of interest in this study (N100, P300, N400), proprietary auditory stimulus sequences will be administered using the NeuroCatch Platform 2, an investigational medical device. Each sequence consists of tones and word pairs to elicit the various components of interest. The NeuroCatch Platform 2 consists of a computerized acquisition software which presents the stimulus, acquires the data and presents the amplitude and latency values of the ERP components (N100, N400, P300)
15738426|NCT04956159|Device|iTBS repetitive Transcranial Magnetic Stimulation (rTMS)|rTMS is a non-invasive procedure in which cerebral electrical activity is influenced by a rapidly changing magnetic field. The magnetic field is created by a plastic-encased coil which is placed over the patient's scalp. The magnetic field can be directed onto specific areas of the brain. rTMS can modulate cerebral activity by low or high frequencies. Over time, the magnetic field pulses can gradually change the activity level of the stimulated brain region and help symptoms of depression and anxiety.
15738427|NCT04956159|Device|Sham rTMS|Sham rTMS involves a click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.
15738428|NCT04956146|Drug|Fruquintinib，Sintilimab，Pemetrexed，Carboplatin|Fruquintinib,fruquintinib at the dose determined in phase safety lead-in,5mg-intermittent (2 weeks on/ 1 week off) ，po，every 3 weeks(q3w) ; Sintilimab at the dose 200mg，iv, d1, given every 3 weeks (q3w); Pemetrexed at the dose 500 mg/m2，iv，d1，given every 3 weeks (q3w); Carboplatin at the dose AUC=4~5，iv，d1；given every 3 weeks (q3w); Maintenance treatment：After 4~6 cycles of carboplatin treatment, Sintilimab 200mg, iv, d1, q3w；Fruquintinib RP2D intermittent(2 weeks on/1 weeks off), po，q3w； pemetrexed 500mg/m2, d1,iv, q3w until progressive disease, death from any cause, unacceptable toxicity or informed consent withdrawal
15738429|NCT04956133|Behavioral|Physical Activity|Participants will receive the IMPACT program, which includes a combination of aerobic, resistance, balance, and flexibility exercises conducted 1:1 and delivered online by a physical activity specialist via Zoom. The IMPACT program follows basic physical activity progression principles (i.e., principles of frequency, intensity, time, type, overload and progression). Tailoring will be used to promote fitness and wellness benefits, while ensuring safety. In addition, prominent behaviour change techniques will be provided by physical activity specialists within each 1:1 session. Discussions and worksheets will be provided, depending on participants needs.
15738519|NCT04955327|Drug|A. Paniculata|Extract from A. Paniculata
15738431|NCT04956120|Device|Standard Dialysate|Dialysate is generated during dialysate from two concentrates (acid concentrate and bicarbonate concentrate) mixed with treated water. The acid concentrate without citrate is approved for this use by the FDA and will be used according to standard procedures without altered dialysis machine settings.
15738432|NCT04956094|Diagnostic Test|GGT/Uric Acid|Standard laboratory blood testing for GGT and uric acid levels.
15738433|NCT04956081|Device|Neuro-navigated Transcranial Magnetic Stimulation (TMS)|TMS delivered to a target within the left- dorsolateral prefrontal cortex (L-DLPFC)
15738434|NCT04956068|Combination Product|PIPAC|A novel drug delivery system using the CapnoPen device which allows the aerolisation of chemotherapeutic agents within the peritoneal cavity. PIPAC procedure will be carried out with either oxaliplatin or doxorubicin/ cisplatin.
15738435|NCT04956055|Other|Reflexology|The patient will be kept in a lying position. First, the patient will be given four minutes of hand reflexology on each hand with warming and stimulation techniques.Reflexology will be applied to the left hand with the thumb of the right hand, the thumb of the left hand and the special points in the right hand. It will be applied to the fingers, palm, back of the hand, and finally the wrists, respectively, starting with the fingertips and using special reflexology techniques (a total of six minutes for each hand separately). By sending a moderate stimulus, a total of 20 minutes of reflexology session will continue.Since the patient reveals and uses his own internal energy at the end of the session, nobody should talk to the patient until five minutes after the procedure. Survey questions and vital signs would be examined five minutes after the session and the research with the participant would end.
15738436|NCT04956042|Drug|Fosciclopirox|Fosciclopirox, 900 mg/m2 administered as a 20-minute IV infusion once daily on D1-D5 of each 21-day treatment cycle
15738437|NCT04956042|Drug|Fosciclopirox + Cytarabine|"Fosciclopirox - 900 mg/m2 administered as a 20-minute IV infusion once daily on D1-D5 of each 21-day treatment cycle
~Cytarabine - 1g/m2 once daily on D1-D5 of each 21-day treatment cycle"
15738438|NCT04956029|Other|There are no any interventions. This is to observe and test hospital cleanliness.|There are no any interventions. This is to observe and test hospital cleanliness.
15738439|NCT04956016|Device|classic rTMS using the 8-shaped coil|20 rTMS sessions are planned (5 sessions per week)
15738440|NCT04956016|Device|deep rTMS using the H-shaped coil|20 rTMS sessions are planned (5 sessions per week)
15738441|NCT04956003|Behavioral|45-minute daily physical activity|45-minute daily physical activity session as an integral part of learning (during regular school sessions)
15738442|NCT04955990|Drug|PAH Therapies|PAH therapies will be administered in a real-world clinical setting and data will be collected from participants who newly initiate any PAH therapy(ies). Participants will receive PAH therapies such as Macitentan, Ambrisentan, Bosentan, Tadalafil, Sildenafil, Riociguat, Selexipag, Epoprostenol, Iloprost, andTreprostinil.
15738443|NCT04955977|Other|Physical exercise program|"Step 1 • Diaphragmatic reeducation: • Aerobic capacity: Intensity: zone 2, 60% HRMax, 4-6 / 10 Borg Scale; Charge: 20 m.
~Step 2 • Aerobic capacity: Intensity: zone 2, 65% HRMax, 4-6 Borg Scale; Charge: 25 m. • Muscular strength: Method: Pyramidal; Intensity: 3-4 / 10 Omni-Res; Load: 20% 1RM; Series: 3; Reps: 1. • Flexibility and elasticity: Intensity: 31-60 Perflex Scale; Charge: 10 - 20 s.
~Step 3 • Aerobic capacity: Intensity: zone 3, 70% HRMax, 5-6 / 10 Borg scale, Load: 25 m. • Muscular strength: Method: Pyramidal; Intensity: 4-5 / 10 Omni-Res; Load: 30% 1RM; Series: 4; Reps: 10. • Flexibility and elasticity: Method: active stretching; Intensity: 31-60 Perflex Scale; Charge: 10 - 20 s.
~Step 4 •Aerobic capacity: Intensity: zone 3, 75% HRMax, 6-7 / 10 Borg scale, Load: 30 m. • Muscular strength: Intensity: 5-6 / 10 Omni-Res; Load: 40-50% 1RM; Series: 4 s; Reps: 13. • Flexibility and elasticity: Method: active stretching; Intensity: 31-60 Perflex Scale; Charge: 10 - 20 s."
15738444|NCT04955977|Other|Health education in COPD|Week 1-2: Health education: COPD and respiratory care at home. Week 3-4: Importance of daily physical activity in COPD. Week 5-6: Early Signs of COPD Exacerbation and Action Plan Week 7-8: Use and care of respiratory devices at home.
15738445|NCT04955951|Device|polarized light|A Bioptron light therapy phototherapeutic device (Bioptron AG, Wollerau, Switzerland) with 5 cm treatment diameter (BIOPTRON MedAll®, 480-3400 nm, polarization level of 95%, power density 40 mW/cm2, energy density 2,4 J/cm2 per minute
15738446|NCT04955951|Drug|Topical corticosteroid ointment|corticosteroid 1 %.
15738447|NCT04955938|Drug|Ivosidenib|A drug used to treat acute myeloid leukemia that has a mutated (changed) form of a gene called isocitrate dehydrogenase-1 (IDH1).
15738448|NCT04955938|Drug|Enasidenib|A drug used to treat acute myeloid leukemia (AML) that has recurred (come back) or has not gotten better after treatment with other anticancer therapy.
15738449|NCT04955938|Drug|Fedratinib|This medication is used to treat a certain type of cancer (myelofibrosis). Fedratinib belongs to a class of drugs known as JAK (janus kinase) inhibitors. It works by slowing or stopping the growth of cancer cells.
15738450|NCT04955925|Diagnostic Test|Ultrasound examination of the optic nerve sheath diameter|The optic nerve sheath diameter is examined using ultrasonography.
15738451|NCT04955912|Other|music medicine|To reduce premenstrual symptoms by applying music medicine to people with premenstrual syndrome
15738453|NCT04955886|Drug|Surufatinib(HMPL-012)|Surufatinib(250mg) will be orally administered within 1 hour after breakfast once a day (QD) , Toripalimab was administered intravenously at a fixed dose of 240 mg, and the infusion time was 60 ± 5 min, once every 21 days. The cumulative longest medication period is 2 years. Until disease progression, death, intolerable toxicity or other protocol specified end-of-treatment criteria is met .
15738454|NCT04955873|Device|Treatment of the dental extraction socket using newly-released biomaterials|Treatment of the dental extraction socket with the combined use with the combined use of a newly-released xenogenic bone granules and a resorbable collagen membrane.
15738455|NCT04955873|Device|Treatment of the dental extraction socket using well-known biomaterials|Treatment of the dental extraction socket with the combined use of a well-known xenogenic bone granules and a resorbable collagen membrane
15738456|NCT04955860|Other|Dental model analysis|No interventional treatment intervention will be made for individuals. Digital dental models taken for orthodontic recording will be examined.
15738457|NCT04955834|Drug|Insulin degludec injection|long-acting insulin
15738458|NCT04955834|Drug|Tresiba®|long-acting insulin
15738520|NCT04955327|Drug|A. Chilensis|Extract from A. Chilensis
15738459|NCT04955821|Diagnostic Test|mNGS diagnose of VAP|This study is an observational study to evaluate the accuracy of pathogens in children with VAP tested by mNGS with no intervention. All patients from the cohort accept mNGS test and bacterial culture or virus PCR detection. A double sputum specimens are used for test.The reference standard is bacterial culture or virus PCR detection.
15738460|NCT04955808|Procedure|Biospecimen Collection|Undergo collection of tissue and blood samples
15738461|NCT04955808|Other|Laboratory Biomarker Analysis|Correlative studies
15738462|NCT04955795|Behavioral|Alcohol Brief Intervention (BI)|The BI we will use was based on CETA's substance use module and was designed for one-on-one delivery. It is comprised of 6 elements (i.e. assessment, understanding impacts, exploring change, goal setting, identifying the reasons, and skill building) including a 2-week alcohol timeline follow back assessment, which is completed by the therapist. BI will be provided by a trained research assistant who has completed consent, enrollment, and randomized procedures with the client.
15738463|NCT04955795|Behavioral|Common Elements Treatment Approach (CETA) via Telemedicine|CETA consists of nine key elements (i.e. engagement and education; safety assessment and planning; psychoeducation/introduction; substance use reduction; behavioral activation; cognitive coping/restructuring; relaxation; exposure; and problem solving) that address common mental health problems such as trauma, PTSD, depression, and anxiety. Participants randomized to CETA will be assigned to a CETA provider (clinical psychology or social work graduate student or master's degree substance abuse counselor). Enrolled participants will be discussed at weekly supervision meetings. An individualized treatment plan will be designed for each participant including type and order of CETA modules. The counselor will contact the participant by phone to schedule CETA sessions and follow up any missed appointments. Counselors, who will also be given a unique ID# for documentation and analysis, will carry 3-10 active CETA cases at a time depending on their experience level.
15738464|NCT04955782|Behavioral|samples will be analyzed for semen volume, pH, count, concentration, motility, morphology and viability|"The volume will be measured by weighing the sample in the container in which it has been collected, it will be a pre-weighed container. The volume will be assessed by aspirating the sample using a non-toxic pre scaled surgical pipette.
~The samples will be liquified in an incubator at 37 C. Complete ejaculate liquefaction is normally achieved within 15-30 minutes at room temperature (WHO2010).
~pH will be analyzed 30 minutes after collection. pH test strips in range of 6.0-10.0 will be used. A value under 7.0 will indicate lack of alkaline seminal vesicular fluid (pH-Fix 0-14 from Macherey-Nagell,Germany).
~The samples concentration and motility will be analyzed in laboratory by Neubauer chamber, morphology will be assessed by RAL Diff-Quik kit (3x0.5L) from RAL Diagnostics, France as per the manufacturers' recommendation.
~Vitality will be analyzed by Vital screen, FertiPro N.V. Belgium,as per guidelines of manufacturer"
15738465|NCT04955756|Diagnostic Test|mNGS|Participants will be randomized to receive mNGS or multiplex PCR for diagnosis at enrollment.
15738466|NCT04955756|Diagnostic Test|Multiplex PCR|Participants will be randomized to receive mNGS or multiplex PCR for diagnosis at enrollment.
15738467|NCT04955743|Drug|Pembrolizumab|200 mg intravenous (IV) is administered every 3 weeks
15738468|NCT04955743|Drug|Lenvatinib|20 mg orally (PO) is administered daily
15738469|NCT04955730|Device|Negative Pressure Wound Therapy|Negative Pressure Wound Therapy is a single use NPWT that produces a negative pressure at -80 mmHg. Participants will have their fascia and skin closed in the same manner as the control arm participants, and will wear the NPWT dressing for 7 days after surgery.
15738470|NCT04955717|Diagnostic Test|Chlamydia trachomatis and Neisseria gonorrhoeae testing using the GeneXpert|Chlamydia trachomatis and Neisseria gonorrhoeae testing using the GeneXpert
15738471|NCT04955704|Device|InferRead CT Pneumonia.AI|InferRead CT Pneumonia.AI reads chest CT DICOM images from medical imaging storage devices and triages cases by detecting pneumonia lesions and then flagging suspected cases in the study list. InferRead CT Pneumonia.AI is a tool to assist clinicians and it does not replace the interpretation and diagnosis by clinicians.
15738472|NCT04955691|Other|low carbohydrate diet|Participants will engage in a diet that limits carbohydrate intake to 15% of total daily calories for 2 weeks.
15738473|NCT04955691|Other|standard carbohydrate diet|Participants will engage in a diet that recommends standard carbohydrate intake with respect to total daily calories for 2 weeks.
15738474|NCT04955678|Drug|Calcium, hydrolysed divinylbenzene-Me 2-fluoro-2-propenoate-1, 7-octadiene polymer sorbitol complexes|ZG-801 is powder for suspension. In Run-in period, ZG-801 is taken once a day for 4 or 5 weeks. In Double-blind period, ZG-801 is taken once a day for 4 weeks.
15738475|NCT04955678|Drug|Placebo|Placebo is powder for suspension. In Double-blind period, Placebo is taken once a day for 4 weeks.
15738476|NCT04955665|Procedure|bone block procedure|a 20 × 15 × 3 mm3 bone block was cut from the lateral malleolus, rotated backwards 45°, and sutured back to the periosteum of the lateral malleolus using non-absorbable sutures.
15738477|NCT04955665|Procedure|Reattachment of the superior peroneal retinaculum|two suture anchors (Mini Quickanchor,DePuy Mitek) were inserted into the postero-lateral ridge of the lateral malleolus without damaging the cartilaginous ridge, after which the SPR was reattached to the lateral malleolus with the anchored suture. The inner layer of the false pouch was incised, and the outer layer (periosteum) was sutured with the SPR in a pants-over-vest style.
15738478|NCT04955652|Behavioral|Health Maintenance Topic|Alert
15738479|NCT04955652|Behavioral|Actionable Sidebar Item|Alert
15738480|NCT04955652|Behavioral|Best Practice Alert|Alert
15738481|NCT04955639|Other|Control|Standard of Care - Control Smoking Cessation Program
15738482|NCT04955639|Other|Pivot|Pivot Program Smoking Cessation Program
15738485|NCT04955613|Device|MyMove/VR system|"The treatment system consists of two lightweight MyMove bands and Virtual-Reality (VR) gear. Proprietary software and content allow tracking of performance in real-time, with feedback to both the patient and treating - personnel.
~MyMove is a wearable device that allows patients with loss of upper limb function to operate computers, cellular phones, and similar devices. The technology is non-invasive and does not involve risk to the patient.
~Virtual-Reality (VR) gear is a wearable computer running within goggles that project content and allow for interaction using controllers."
15738486|NCT04955613|Device|Mirror therapy|Mirror therapy or mirror visual feedback is a therapy for pain or disability that affects one side of the patient more than the other side
15738487|NCT04955600|Other|Implementation Study|Implementation of digital technology in two different care settings from both patients, informal caregivers, and healthcare professional's perspective.
15738488|NCT04955574|Other|SH-DS01 + Antibiotic Placebo|Participants will be instructed to take 2 capsules of SH-DS01 probiotic once daily (at lunch) from cycle day 1 to the day of ovulation/day of luteal progesterone initiation, followed by 2 capsules of SH-DS01 probiotic once daily (at lunch) and 1 capsule of placebo for antibiotic twice daily (at breakfast and dinner) from the day of ovulation/day of luteal progesterone initiation to the day of frozen embryo transfer.
15738489|NCT04955574|Drug|SH-DS01 + Metronidazole|Participants will be instructed to take 2 capsules of SH-DS01 probiotic once daily (at lunch) from cycle day 1 to the day of ovulation/day of luteal progesterone initiation, followed by 2 capsules of SH-DS01 probiotic once daily (at lunch) and 1 capsule of 500mg metronidazole twice daily (at breakfast and dinner) from the day of ovulation/day of luteal progesterone initiation to the day of frozen embryo transfer.
15738490|NCT04955574|Other|Probiotic Placebo + Antibiotic Placebo|Participants will be instructed to take 2 capsules of placebo for probiotic once daily (at lunch) from cycle day 1 to the day of ovulation/day of luteal progesterone initiation, followed by 2 capsules of placebo for probiotic once daily (at lunch) and 1 capsule of placebo for antibiotic twice daily (at breakfast and dinner) from the day of ovulation/day of luteal progesterone initiation to the day of frozen embryo transfer.
15738491|NCT04955561|Other|Oxygen therapy|Supplemental O2 at rest of 10 l/min for ten minutes followed by supplemental O2 at the prescribed exercise O2-flow rate during ESWT.
15738492|NCT04955561|Other|Medical Air|Supplemental O2 at rest of 10 l/min for ten minutes followed by medical Air at prescribed O2 flow rate during ESWT.
15738493|NCT04955561|Other|10L/min O2|Supplemental O2 at rest of 10 l/min for ten minutes followed by 10L/min O2 during ESWT.
15738494|NCT04955548|Procedure|arthroscopic micro-fracture with autologous adipose gel|Fully cut the adipose tissue taken out under the arthroscopy, transfer the cut adipose tissue to a syringe connected with a double pass, push back and forth through the syringe to physically emulsify the adipose, and centrifuge to obtain the autologous adipose gel, and inject it into the lesion
15738495|NCT04955548|Procedure|arthroscopic micro-fracture|Surgeons routinely perform international standard micro-fracture surgery to repair cartilage damage
15738496|NCT04955535|Procedure|Arthroscopic synovectomy|Arthroscopic synovectomy
15738497|NCT04955522|Diagnostic Test|radiomics|Differential diagnosis of spinal myeloma and metastases by radiomics
15738498|NCT04955509|Other|MRI|conventional MRI and diffusion MRI
15738499|NCT04955496|Procedure|Enhanced recovery after surgery|ERAS management includes 3 parts: (1) Preoperative analgesia and airway evaluation. (2) The protection and reconstruction of the musculo-ligamentous complex during the surgery, the safe intubation, and the local infiltration anesthesia during surgery. (3) Collar free, multimodal analgesia, airway management, and early recovery after surgery.
15738500|NCT04955483|Diagnostic Test|Virtual single energy combined with MAR reconstruction group|combined with MAR reconstruction group
15738501|NCT04955470|Drug|Ketamine Injectable Solution|A 10 mg/mL solution of ketamine will be infused over a 40 minute period at a dose of 0.05mg/kg.
15738502|NCT04955470|Drug|Midazolam Injectable Solution|A 5 mg/mL solution of midazolam will be infused over a 40 minute period at a dose of 0.02 mg/kg.
15738503|NCT04955470|Drug|Normal Saline 0.9% Injectable Solution|A 0.9% normal saline solution will be infused over a 40 minute period.
15738504|NCT04955457|Other|Healthy women active teachers|The neuropsychological testing data, psychometric measure, demographic, clinical and lifestyle information and blood samples were collected at similar time points. This group not received any intervention.
15738505|NCT04955444|Other|Quality improvement bundle|The quality improvement bundle consists of (1) patient education, (2) provider education, and (3) EHR enhancements including order sets and best practice alerts.
15738506|NCT04955431|Behavioral|Sleep Restriction|Participants will be allowed ~4 hour sleep opportunity during the restricted night of sleep prior to reporting to lab for a simulated firefighting session.
15738507|NCT04955431|Behavioral|Normal Sleep|Participants will be allowed ~8 hour sleep opportunity the night of sleep prior to reporting to lab for a simulated firefighting session.
15738508|NCT04955418|Device|Epi-No®|evaluation, 10 sessions (twice a week for 5 weeks) of perineal preparation with the Epi-No device and revaluation six months after delivery.
15738509|NCT04955418|Diagnostic Test|Evaluation|evaluation (anamnesis, childbirth data, perineometry, International Consultation on Incontinence Questionnaire - Short Form, Female Sexual Function Index) six months after vaginal delivery.
15738511|NCT04955392|Other|Osteopathic treatment protocol|"The intervention protocol consists of 4 techniques that will be performed according to the following order:
~Inhibition of the suboccipital muscles.
~Parietal Lift.
~Sutherland Technique of Sphenobasilar Synchondrosis.
~Compression technique of the fourth ventricle (CV4)."
15738512|NCT04955392|Other|Sham technique|Sham technique that consists of placing the hands on top of the skull without any therapeutic intention for five minutes.
15738513|NCT04955379|Device|EQ103|Ophthalmic Refractometer with a measurement and background channel
15738514|NCT04955366|Drug|Belatacept|Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg monthly
15738515|NCT04955366|Drug|Abatacept|Abatacept is an immunosuppressive medication and will be given SQ at a dose of 125 mg s.c. weekly
15738516|NCT04955353|Dietary Supplement|AVC-H2|A total of 2.5g AVC-H2 daily (2 tablets in the morning and 2 in the evening)
15738517|NCT04955353|Dietary Supplement|Placebo|A total of 2.5g placebo daily (2 tablets in the morning and 2 in the evening)
15738518|NCT04955340|Drug|[14C]-resminostat|1 single dose of 400 mg [14C]-resminostat
15738523|NCT04955314|Other|PA vertebral mobilization|A PA mobilization is a technique in which one vertebra slides over another due to a force applied with the hands of the physiotherapist
15738524|NCT04955301|Behavioral|Priming intervention|The priming manipulation will be embedded in one discrete choice experiment to test the effect of three priming interventions: priming with health benefits, environment benefits, and co-benefits of having sustainable diets, respectively, on consumers' preference for sustainable foods, and the relative importance of proximal attributes (e.g. taste and price) and distant attributes (e.g., attributes related to environmental sustainability) in determining food choice preference, as well as testing whether the effects of these three priming interventions can be modified by consumers' social orientation values. The cueing manipulation will be achieved by asking participants to complete a word-search exercise.
15738525|NCT04955288|Procedure|Aortic balloon assisted resuscitation|On the basis of the traditional resuscitation mode, the aortic balloon occlusion technology is used, that is, at the same time when the cardiopulmonary resuscitation starts, the aortic balloon catheter is quickly punctured to the distal end of the aortic zone I (septum level) through ultrasound assistance, and then Continue to inflate the balloon to block the aortic blood flow until the end of the cardiopulmonary resuscitation to deflate the balloon and remove the balloon catheter.
15738526|NCT04955288|Procedure|Traditional cardiopulmonary resuscitation|"Use the traditional manual chest compression mode, that is, refer to the latest version of the CPR Guidelines.
~Artificial chest compressions are performed under the monitoring of the pressure quality feedback device to ensure that the compression depth is 5-6cm, the frequency is 100-120 times/min, the compression position is fixed, and the chest wall fully rebounds."
15738527|NCT04955288|Procedure|Esophageal cooling|The new transesophageal cooling method is adopted, that is, the esophageal cooling catheter is indwelled after resuscitation in patients with cardiac arrest, and then connected to a small temperature-controlled water circulation system to continuously infuse 4℃ cold water. After the patient's body temperature reaches the target temperature of 33℃, the temperature-controlled water circulation system is adjusted Maintain the target body temperature of (33±0.5)°C for 24 hours, and then rewarm to (37±0.5)°C normal body temperature at a rate of 0.25-0.5°C/h and maintain it for 24 hours.
15738528|NCT04955288|Procedure|traditional cooling|The traditional body surface ice blanket cooling method is adopted, that is, the patient with cardiac arrest lies on the temperature control blanket after resuscitation, and then uses the ice blanket host to continuously infuse the temperature control blanket with 4℃ cold water, and wait until the patient's body temperature reaches the target temperature of 33℃. The temperature of the circulating water is controlled by adjusting the ice blanket host to maintain the target body temperature of (33±0.5)°C for 24 hours, and then reheat to the normal body temperature of (37±0.5)°C at a rate of 0.25-0.5°C/h and maintain it for 24 hours.
15738529|NCT04955275|Other|Cognitive Remediation Therapy Program (Lumosity)|Lumosity games involving training cognitive abilities like memory and attention, made up of adapting tasks or creating our own.
15738530|NCT04955262|Biological|Bempegaldesleukin (NKTR-214)|Specified dose on specified days
15738531|NCT04955262|Biological|Nivolumab|Specified dose on specified days
15738532|NCT04955262|Drug|⁸⁹Zr-Df-IAB22M2C|Specified dose on specified days
15738533|NCT04955249|Drug|Dexmedetomidine|Patients in this group receive dexmedetomidine-supplemented patient-controlled analgesia for up to 3 days after surgery. The formula is a mixture of dexmedetomidine (1 microgram/ml) and sufentanil (1 microgram/ml), diluted with normal saline to 200 ml. The analgesic pump is programmed to administer a background infusion at a rate of 1 ml/h, with a bolus dose of 2 ml at each time and a lockout interval of 8 minutes.
15738534|NCT04955249|Drug|Placebo|Patients in this group receive routine patient-controlled intravenous analgesia for up to 3 days after surgery. The formula is a mixture of placebo and sufentanil (1 microgram/ml), diluted with normal saline to 200 ml. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with a bolus dose of 2 ml at each time and a lockout interval of 8 minutes.
15738537|NCT04955223|Drug|Yinhu Qingwen Granules|For mild and common patients, take 1 bag 2 times a day. For severe patients, take 1 bag 3 times a day.
15738539|NCT04955197|Diagnostic Test|exfoliated cytology|Micronuclei (MN) are small chromatin bodies in the cytoplasm formed by chromosome fragments or whole chromosomes that fail to be included in the nuclei during cell division. They are considered as a sensitive indicators of genetic damage. They are usually found in the basal cells of epidermis and are shed as exfoliated cells on maturation. Hence micronuclei assay can be used as monitoring of genetic damage, as it is increased in oral neoplastic conditions. Consequently, an increase in the number of micronuclei in exfoliated cells indicates an increased risk for cancer
15738540|NCT04955184|Device|non-invasive monitoring|non-invasive measurements of cardiac output
15738541|NCT04955171|Drug|BEOVU intravitreal injection|BEOVU intravitreal injection
15738542|NCT04955158|Drug|Dexmedetomidine|75 µg dexmedetomidine soaked pharyngeal pack (Group D) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.
15738543|NCT04955158|Drug|Ketamine|50 mg ketamine soaked pharyngeal pack (Group K) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.
15738544|NCT04955158|Other|saline 0.9%|20 ml 0.9% saline soaked pharyngeal pack (Group C) putted in the posterior pharyngeal wall after induction of anesthesia and ETT.
15738545|NCT04955145|Drug|RUTA C 60|Rutin known as vitamin p or rotoside and C-retard is Ascorbic acid
15738547|NCT04955119|Diagnostic Test|Fusion imaging contrast-enhanced ultrasound|"Fusion imaging contrast-enhanced ultrasound will be performed for patients with invisible lesion at conventional ultrasound.
~Drug: SonoVue"
15738548|NCT04955106|Diagnostic Test|SEM Scanner|They will perform 2 sets of 3 measures (1 on sacrum, 1 on the right heel and 1 on the left heel)for each patients
15738549|NCT04955093|Device|Biofeedback|Technology to provide Heart Rate Variability Biofeedback
15738550|NCT04955067|Diagnostic Test|Diagnositic test|The results of hip arthroscopy were taken as the gold standard, and MRI examination was taken as the research object
15738551|NCT04955054|Diagnostic Test|diagnose|Patients from UAP and AMI meet the criteria of UAP or STEMI.
15738552|NCT04955041|Other|MRI|T2* MRI
15738553|NCT04955015|Procedure|carotid endarterectomy|patients with carotid atherosclerosis refering to CEA
15738554|NCT04955002|Other|No intervention|No intervention
15738555|NCT04954989|Biological|Experimental Erythropoietin subcutaneous injection single dose of 4,000 IU|Recombinant Human Erythropoietin: single dose of 4,000 IU (syringe filled with 0.4 mL with 4,000 IU) of the experimental drug should be administered subcutaneously
15738556|NCT04954989|Biological|Active comparator Erythropoietin Eprex® subcutaneous injection single dose of 4,000 IU|Recombinant Human Erythropoietin: single dose of 4,000 IU (syringe filled with 0.4 mL with 4,000 IU) of Eprex® should be administered subcutaneously
15738557|NCT04954976|Other|Orthodontic retention procedures survey|The survey was composed of eight parts, about sociodemographic status, retention system selection, choice of fixed and removable retention system, retention period, supervision, given instruction and needs for practice guidelines.
15738558|NCT04954963|Diagnostic Test|Reduce metal artifacts examination|patients undergo reduce metal artifacts examination
15738559|NCT04954950|Other|no intervention|no intervention
15738560|NCT04954924|Other|standardized physiotherapy program and Kinesio tape|
15738561|NCT04954898|Device|Study Lens: TECNIS Multifocal Toric 1-piece lens, Model ZMT|Surgeons will perform standardized, small-incision, cataract surgery and implant the study lenses using a JJSV-validated insertion system qualified for use with TECNIS Multifocal Toric 1-Piece IOL.
15738562|NCT04954885|Procedure|Biospecimen Collection|Undergo stool sample
15738563|NCT04954885|Other|Physical Performance Testing|Undergo short physical performance battery
15738564|NCT04954885|Other|Physical Performance Testing|Perform 6-minute walk test
15738565|NCT04954885|Other|Questionnaire Administration|Complete questionnaires
15738566|NCT04954872|Behavioral|Standard Problem Management Plus training (training as usual)|10-day training on Problem Management Plus.
15738567|NCT04954872|Behavioral|Equip-based Problem Management Plus training|Training and supervision for Problem Management Plus in which the trainers and supervisors use the EQUIP platform for competency assessment and feedback.
15738569|NCT04954846|Dietary Supplement|OMNi-BiOTiC SR-9|"The Probiotic contains the following ingredients:
~Maize Starch, Maltodextrin, Inulin, Potassium Chloride, Hydrolysed rice protein, Magnesium Sulphate, Fructooligosaccharides, Amylase, Manganese Sulphate
~Additionally, the following bacterial strains are included:
~Lactobacillus Casei W56, Lactobacillus Acidophilus W22, Lactobacillus Paracasei W20, Bifidobacterium lactis W51, Lactobacillus salivarius W24, Lactococcus lactis W19, Bifidobacterium lactis W52, Lactobacillus plantarum, Bifidobacterium bifidum W23"
15738570|NCT04954846|Dietary Supplement|Placebo|The Placebo contains no bacterial strains, only the prebiotic ingredients found in OMNi-BiOTiC SR-9.
15738571|NCT04954820|Drug|Lutathera|2 additional infusions of Lutathera®
15738572|NCT04954807|Dietary Supplement|human milk fortified|HMF will be given 6 scoops a day
15738573|NCT04954807|Dietary Supplement|placebo|Placebo will be given six scoops a day
15738574|NCT04954794|Drug|Sintilimab|Sintilimab will be administered at 200 mg i.v. every 3 weeks plus a bevacizumab biosimilar at 15 mg/kg i.v. every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
15738575|NCT04954794|Combination Product|TACE|TACE is performed by using drug-eluting beads or using microspheres combined with Lipiodol-pirarubicin emulsion per Investigator's decision. TACE treatment starts at day 0. Sintilimab plus a bevacizumab biosimilar will be initiated on day 14 after TACE.
15738576|NCT04954781|Drug|Tislelizumab|Tislelizumab will be initiated on day 14 after the first TACE session. Tislelizumab will be administered at 200 mg i.v. every 3 weeks until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
15738577|NCT04954781|Combination Product|TACE|TACE is performed by using drug-eluting beads. TACE treatment starts on day 0. The second TACE will be repeated on day 28 (± 5 days) if necessary per Investigator's decision.
15738578|NCT04954742|Drug|Riociguat|Treatment will be initiated and individually adjusted according to systolic blood pressure and tolerability. During the titration phase, each patient will be asked to measure their peripheral systolic blood pressure and the heart rate at home three times per day and document the values in the patient diary. The results will be examined by the investigator during each visit/phone call-visit. Provided that the systolic blood pressure is ≥ 95 mmHg measured at trough before intake of each dose and the patient has no signs or symptoms of hypotension, the dose of study medication will be titrated by +0.5 mg tid every 2 weeks until maximal tolerated dosage (maximal permitted dose: of 2.5 mg tid). After the titration period, blood pressure should be measured upon signs or symptoms of hypotension. Maintenance dose: The established individual dose should be maintained unless signs and symptoms of hypotension occur.
15738579|NCT04954716|Other|Deep Neck Flexor Massage|Deep friction massage is a specific connective tissue massage that was given across the affected fibers.The therapist's fingers and patient's skin must move as one, otherwise moving subcutaneous fascia against muscle or ligament could lead to blister formation or subcutaneous bruising.The friction massage must have sufficient sweep and be deep enough.
15738860|NCT04952116|Other|Eyelid reconstruction|Assessment of differrent techniques in anterior and posterior lamella reconstruction after periocular defects
15738580|NCT04954716|Other|Post-Isometric Relaxation Technique|The PIR technique is performed as follows.The hypertonic muscle is taken to a length just short of pain, or to the point where resistance to movement is first noted.A submaximal (10-20%) contraction of the hypertonic muscle is performed away from the barrier for between 5 and 10 seconds and the therapist applies resistance in the opposite direction . The patient should inhale during this effort.After the isometric contraction the patient is asked to relax and exhale while doing so.Following this a gentle stretch is applied to take up the slack till the new barrier.Starting from this new barrier, the procedure is repeated two or three times.
15738581|NCT04954703|Other|Muscle energy technique of gluteus maximus and tensor fascia lata|it is used for lengthening of hypertonic muscles for relief of pain and range of motion.Position of patient is supine lying and therapist is at side of table .The patient leg is fully adducted to stretch IT band and then patient attempts to abduct the leg against resistance contracting the muscles being stretched at approximately 25% of maximum effort for 10 seconds. They then relax and the therapist lengthen it.
15738582|NCT04954703|Other|Myofascial release of iliotibial band syndrome|Myofascial release of IT band Syndrome. Therapist fingers track up and down your ITB with fingertips to find the most tender spots and use a tennis ball to apply small, circular, light release in those places.
15738583|NCT04954690|Behavioral|Structured Program of exercise for Recipients of Kidney Transplantation (WC)|Structured Program of exercise for Recipients of Kidney Transplantation (weekly coaching)
15738584|NCT04954690|Behavioral|Structured Program of exercise for Recipients of Kidney Transplantation (WC + CG)|Structured Program of exercise for Recipients of Kidney Transplantation (weekly coaching + caregiver participation)
15738585|NCT04954690|Behavioral|Usual Care|Usual Care
15738586|NCT04954677|Other|AI-box|Automatic quality-control system（AI-box）could real-time measure endoscopic inspection completeness, evaluate gastric cleanliness.
15738587|NCT04954664|Biological|Allograft particles hydrated with rhPDGF|Allograft particles should be hydrated with GEM21S for 20 minutes prior to grafting. The graft sites will be covered with a resorbable barrier membrane.
15738588|NCT04954664|Biological|Allograft particles hydrated in a conventional way with saline.|Allograft particles should be hydrated with saline for 20 minutes prior to grafting. The graft sites will be covered with a resorbable barrier membrane
15738589|NCT04954651|Biological|Approved vaccines against Sars-Cov2|Subjects who voluntarily are vaccinated against Sars-Cov-2 with any of the approved vaccines by EU
15738590|NCT04954638|Other|endodontic desinfection|"outcome assessment of the retreatment of endodontically treated teeth presenting chronic apical periodontitis
~effectiveness of hyperpure chlorine dioxide compared with sodium hypochloride
~using microbiological methods
~outcome assessed by radiological method and clinical evaluation"
15738591|NCT04954625|Procedure|Autologous Blood Patch|All patients will be assessed on the morning of postoperative Day 3 and 4 for the presence of an air leak. If an air leak is present, 60-100 ml of autologous blood will be drawn from a peripheral vein and immediately instilled into the chest tube. The individual who draws blood is that the discretion of the site principal investigator. The tubing will be elevated over an IV pole while the patient remains in bed, moving position every 15 minutes for 1 hour to distribute the blood throughout the pleural cavity. The tubing support will then be removed, allowing the chest tube to drain. After ABP intervention, the chest tube will remain to water seal, as long as the patient tolerates it.
15738592|NCT04954625|Procedure|Standard of Care (per Physician)|Patients randomized to Standard of Care will be treated as their surgeon would as routine. This may mean postoperative observation, of another type of intervention.
15738593|NCT04954612|Other|Questionnaire study (Cross-sectional analytical clinical research)|Questionnaire study (Cross-sectional analytical clinical research)
15738594|NCT04954599|Drug|CP-506|CP-506 is a hypoxia-activated DNA alkylating agent specifically designed to have a bystander effect, aqueous solubility, oral bioavailability, and no off-mechanism activation by the human aerobic reductase AKR1C3
15738595|NCT04954599|Drug|Carboplatin|Antineoplastic agent, ATC Code: LO1X A02
15738596|NCT04954599|Drug|Immune checkpoint inhibitor|Drug that blocks immune checkpoint proteins: PD-1, PD-L1, CTLA-4
15738597|NCT04954586|Other|PainCare Yoga|Participants will attend a twice weekly exercise program.
15738598|NCT04954573|Radiation|infrared-A (wIRA)|Local-water filtered infrared-A (wIRA) irradiation
15738599|NCT04954560|Drug|losartan and eprosartan|. Each study drug was given in a random order as a single morning dose (50 mg of losartan or 600 mg of eprosartan) for two periods each lasting 3 months separated by 2-week wash-out time.
15738600|NCT04954547|Behavioral|Subsidy Treatment|Participants will be awarded $50 for reaching the PBF goal at the end of 12 weeks. Regardless of goal-attainment, participants will be reimbursed 50% of approved health-improving expenses up to a cap of $300 in the 12 weeks. The subsidy is voluntary and flexible, with no direct intervention from researchers - participants will submit receipts and simply be reimbursed at the end of the experiment (subject to approval from the research team).
15738601|NCT04954547|Behavioral|Cash Treatment|Participants will be awarded $350 for reaching the PBF goal at the end of 12 weeks.
15738602|NCT04954534|Biological|human umbilical cord blood derived mesenchymal stem cells|High dose: 3 x 10^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4-week intervals
15738603|NCT04954521|Drug|Anlotinib|This is an observational study
15738604|NCT04954508|Diagnostic Test|The hug-up test|It is a new physical test used to detect supraspinatus tear
15738605|NCT04954508|Diagnostic Test|EC test|It is a traditional physical test used to detect supraspinatus tear
15738606|NCT04954508|Diagnostic Test|FC test|It is a traditional physical test used to detect supraspinatus tear
15738607|NCT04954508|Diagnostic Test|Neer impingement sign|It is a traditional physical test used to detect supraspinatus tear
15738608|NCT04954508|Diagnostic Test|Hawkins-Kennedy impingement sign|It is a traditional physical test used to detect supraspinatus tear
15738633|NCT04954274|Drug|Cyclic peptide Fertiline|"Upon retrieval, the oocyte will be decoronized and incubated prior to ICSI procedure into CSCC-M medium supplemented with the molecule.
~After ICSI, the zygote will be incubated in CSCM-C medium supplemented with the peptide."
15738634|NCT04954261|Diagnostic Test|CAPD|CAPD evaluation every day per 12hours during their stay in PICU
15738609|NCT04954508|Diagnostic Test|diagnostic arthroscopy|The arthroscopic operation involved complete inspection of the supraspinatus. Supraspinatus tears were categorized as fullthickness tears (FTTs), which were classified as small (≤1 cm), moderate (≤3 cm), large (≤5 cm), and massive (>5 cm), on the basis of the largest dimension, and partial-thickness tears (PTTs), which were classified as bursal-sided, articular-sided,and intra-tendinous. Other combined diseases including acromioclavicular joint derangement, infraspinatus lesions, subscapularis lesions, superior labrum anterior and posterior (SLAP) lesions, biceps disorders, and Bankart lesions were recorded as well to assess the specificity of the tests.
15738610|NCT04954482|Other|No Intervention|This is an observation study, with no intervention
15738611|NCT04954469|Biological|CoVAC-1|Peptide vaccination should be started as soon as possible after the screening visit.
15738612|NCT04954456|Drug|QLS31901|QLS31901 is a bispecific antibody specifically targeting PD-L1 and TGF-β.In part 1,the QLS31901 will be administered in sequential cohorts on day 1 of every 21-day cycle (3 weeks) via IV infusion.In part 2,the QLS31901 will be administered in parallel cohorts(selected dose and dosing frequency ) on day 1 of every 2week or every 3week via IV infusion
15738613|NCT04954443|Procedure|Removing urinary catheter|Removing urinary catheter after vaginal surgery of pelvic organ prolapse
15738614|NCT04954430|Diagnostic Test|pupillometer|The dynamic changes of PLR were measured using the PLR-3000 pupillometer (NeurOptics, CA, USA), a hand-held portable device. Determination of PLR with automated pupillometry can be performed with a rubber cup covering the measured eye and the subject's hand covering the non-measured eye. A flash of visible white light with a duration of 0.8 sec and a pulse intensity of 50 µW is delivered to induce a pupillary reflex, and repeated video images at more than 30 frames/sec are stored for 6.65 sec. The device provided the examiner with maximum and minimum pupil size (Init and End), constriction percentage (%PLR), latency (LAT), constriction and dilation velocity (CV and DV), and T75.
15738615|NCT04954417|Diagnostic Test|Radiological scanning|The collected specimens subject to normalized Micro-CT and MSCT image acquisition, image reconstruction using standard algorithms, and bone structure observation using bone algorithms to obtain high-quality, standardized axial images.
15738616|NCT04954417|Other|Deep learning|We will use a conditional generation adversarial network-based image mapping technique to train the mapping model between MSCT images and Micro-CT images, find the correspondence between the image information contained in each of MSCT and Micro-CT, and finally obtain high-resolution micro-CT-like images.
15738617|NCT04954417|Procedure|Bio-mechanical testing|we will cut a standardized cubic sample from the vertebral cancellous bone , obtain the bio-mechanical performance index of this cancellous bone sample by mechanical experiments, and analyze the correlation between bone structure of Micro-CT-like images and bio-mechanical index.
15738618|NCT04954404|Device|transcatheter mitral valve repair/transcatheter mitral valve replacement|transcatheter mitral valve repair/transcatheter mitral valve replacement
15738619|NCT04954391|Procedure|Pulsed radiofrequency neuromodulation of the suprascapular nerve only|"PRF stimulation of the suprascapular nerve under ultrasound navigation in the notch of the scapula using the Cosman G4 apparatus with the introduction of stimulation: sensory: 50 Hz; 1 ms; up to 0.5 V; motor: 2 Hz; 1 ms; voltage - twice the sensory threshold, but not less than 1V; after introduction of 1 ml of 0.75% ropivacaine, PRF is performed: 42 С, 45V, 2Hz, 20 ms, 1 cycle - 480 sec. Before removing the cannula, local administration of 0.75% ropivacaine 2 ml, dexamethasone 4 mg.
~Under the US navigation, an RF cannula will be placed sequentially at the axillary nerve in the quadrilateral foramen and at the lateral pectoral nerve. After confirmatory sensory and motor stimulation and local administration of 0.75% ropivacaine 1 ml PRF session imitation lasting 480 sec will be carried out. After that local administration of 0.75% ropivacaine 2 ml, dexamethasone 4 mg will follow. The total dose for the entire procedure is ropivacaine 0.75% - 9 ml, dexamethasone 12 mg"
15738620|NCT04954391|Procedure|Pulsed radiofrequency neuromodulation of the suprascapular, axillary, and articular branch of the lateral pectoral nerves|Under ultrasound navigation an RF cannula will be placed sequentially at the suprascapular nerve, at the axillary nerve and at the lateral pectoral nerve. After confirmatory sensory and motor stimulation from RF generator and local administration of 0.75% ropivacaine 1 ml to each nerve, PRF neuromodulation session will be carried out: 42 С, 45V, 2Hz, 20 ms, 1 cycle - 480 sec to each nerve. After that local administration of 0.75% ropivacaine 2 ml, dexamethasone 4 mg will follow to each nerve. The total dose for the entire procedure is ropivacaine 0.75% - 9 ml, dexamethasone 12 mg
15738621|NCT04954378|Diagnostic Test|radiomics|
15738622|NCT04954365|Drug|Rescue Post-Operative Nausea and Vomiting (PONV) treatment according to the standard of care (SOC)|Rescue Post-Operative Nausea and Vomiting (PONV) treatment
15738623|NCT04954365|Drug|Amisulpride|Rescue Post-Operative Nausea and Vomiting (PONV) treatment with Amisulpride
15738624|NCT04954339|Drug|Aatezolizumab plus Bevacizumab|Two cycles of naeoadjuvant atezolizumab (1200 mg) plus bevacizumab (15 mg/kg) prior to surgical resection and four cycles of adjuvant atezolizumab (1200 mg) plus bevacizumab (15 mg/kg) after the surgery will be administered.
15738625|NCT04954326|Drug|Lyophilized S95014|"Lyophilized S95014 will be intravenously administered over 1 hour at the dose of 2500 U/m2 at Day 3 of the induction phase.
~Patients will receive other backbone chemotherapy agents as per ALL-MB 2015 protocol."
15738626|NCT04954326|Drug|Liquid S95014|"Liquid S95014 will be intravenously administered over 1 hour at the dose of 2500 U/m2 at Day 3 of the induction phase.
~Patients will receive other backbone chemotherapy agents as per ALL-MB 2015 protocol."
15738627|NCT04954313|Drug|Subgingival chlorhexidine irrigation|The dose information for the Chlorhexidine gluconate will be 0.12% with 1 mL in each dental pocket at a frequency of every 3 months for the duration of the study (18 months).
15738628|NCT04954313|Other|Dental Supplies|Subjects in the Treatment Group will receive a commercial electric toothbrush (Colgate hum), toothpaste (Colgate Renewal), mouthwash (Colgate Zero), proxabrush (Colgate), and floss (Colgate Palmolive brand) to be used at home along with instructions on their use. Brush heads for the electric toothbrush will be replaced every 3 months and products (toothpaste, mouthwash, proxabrush, and floss) will be replenished at every site visit.
15738629|NCT04954313|Other|Periodonal Treatment|Initial periodontal treatment consisting of a pre-procedural rinse and scaling & root planing (SRP).
15738630|NCT04954300|Other|no intervention|No intervention
15738631|NCT04954287|Biological|CVXGA1 low dose|see arm/group description
15738632|NCT04954287|Biological|CVXGA1 high dose|see arm/group description
15738652|NCT04954131|Other|Placebo|Saline solution (0.9%)
15738635|NCT04954248|Diagnostic Test|Injected radiotracer with PET Insert|"Informed consent will be obtained before beginning any study procedures.
~Participants will receive a small quantity of an FDA approved radiotracer. The PET insert is placed within a 3T MRI scanner, where PET and MRI imaging will be completed."
15738636|NCT04954209|Other|Physical activities in hospital|3 month in a resumption program of physical activity in hospital
15738637|NCT04954209|Other|Physical activity outside hospital|3 month in a resumption program of physical activity outside hospital with discovery sessions
15738638|NCT04954196|Drug|Amlodipine 5mg|"HRT administration: On Day 1 of the cycle, HRT is planned in accordance with the department's standard practice.
~The frozen embryo transfer will be performed 6 days after progesterone initiation.
~The HRT will be maintained until the pregnancy test is performed: If the test is positive,HRT will be continued for up to 12 weeks of amenorrhea at the same doses and then gradually stopped. If the test is negative,HRT will be stopped gradually
~Amlodipine administration: On the day of the first monitoring Dm (corresponding to D13 D16 of the cycle), a single per os dose of amlodipine 5 mg is taken at night, neither the patient nor the investigator knows what drug is the patient getting. Monitoring is systematically performed the next morning.The treatment will be maintained until the pregnancy test is performed then if the test is positive, the treatment will be maintained for a total duration of 7 weeks."
15738639|NCT04954196|Drug|Placebo|"HRT administration: On Day 1 of the cycle, HRT is planned in accordance with the department's standard practice.
~The frozen embryo transfer will be performed 6 days after progesterone initiation.
~The HRT will be maintained until the pregnancy test is performed: If the test is positive, HRT will be continued for up to 12 weeks of amenorrhea at the same doses and then gradually stopped. If the test is negative, HRT will be stopped gradually
~Placebo administration:On the day of the first monitoring Dm (corresponding to D13-D16 of the cycle), a single per os dose of placebo (Microcrystalline cellulose) is taken at night, neither the patient nor the investigator knows what drug is the patient getting. Monitoring is systematically performed the next morning.. The treatment will be maintained until the pregnancy test is performed, then if the test is positive, the treatment will be maintained for a total duration of 7 weeks."
15738640|NCT04954170|Diagnostic Test|IRRTM|IRRT at maximal 90° abduction and maximal external rotation is performed with the shoulder at maximal 90° rotation and the elbow flexed to 90° (Fig. 2). The patient is then asked to resist the external rotation force applied perpendicular to the forearm by the investigator. The test is considered positive if the patient could not hold the position or if he or she showed weakness of resisted internal rotation compared with the other side. It should be noted the maximal 90° abduction and maximal external rotation is active range of motion. Passive motion may affect the result of the test because of severe pain.
15738641|NCT04954170|Diagnostic Test|the lift-off test|The lift-off test is performed by placing the hand of the affected arm on the back (at the position of the midlumbar spine) and asking the patient to internally rotate the arm to lift the hand off the back [9]. The test is considered positive if the patient is unable to lift the arm posteriorly off the back or if he or she performs the lifting manoeuvre by extending the elbow or the shoulder. Weakness is also as a positive result.
15738642|NCT04954170|Diagnostic Test|the belly-press test|The belly-press test is performed with the arm at the side and the elbow flexed to 90°, by having the patient press the palm into his or her abdomen by internally rotating the shoulder [3, 5]. The test is considered positive (1) if the patient shows a weakness in comparison with the opposite shoulder or (2) the patient pushes the hand against the belly by wrist flexion, despite instruction to the contrary.
15738643|NCT04954170|Diagnostic Test|the IRLS test|IRLS test is evaluated with the affected arm of the patient was held by the examiner at maximum internal rotation [10]. The back of the hand is then passively lifted away from the body until almost full internal rotation is reached. Then, the patient is asked to actively maintain this position. The test is considered positive when the patient fails to maintain the position and the hand lagged.
15738644|NCT04954170|Diagnostic Test|the bear-hug test|The bear-hug test is performed with the palm of one side placed on the opposite shoulder and fingers extended and the elbow positioned anterior to the body [3]. The patient is then asked to hold that position when the examiner tried to pull the patient's hand from the shoulder with an external rotation force applied perpendicular to the forearm. The test is considered positive if the patient could not hold the hand against the shoulder or if he or she showed weakness compared with the other side.
15738645|NCT04954170|Diagnostic Test|IRRT 0°|IRRT at 0° abduction and 0° external rotation is performed with the arm at the side and the elbow flexed to 90° (Fig. 1). The patient is then asked to resist the external rotation force applied by the investigator. The test is considered positive if the patient could not hold the position at the side or if he or she showed weakness of resisted internal rotation compared with the other side. The test is negative if patients only complain of pain.
15738646|NCT04954170|Diagnostic Test|Diagnostic arthroscopy|At the time of surgery, general anaesthesia was administered and the patient was placed in beach-chair position. A complete arthroscopic exploration of the glenohumeral joint and the subacromial space was performed through a standard posterior portal. The senior author performed a complete arthroscopic exploration. Arthroscopic evaluation of the rotator cuff was considered the gold standard for making the definitive diagnosis. Evaluation of the SSC was carried out with both a 30° arthroscope and a 70° arthroscope.
15738647|NCT04954157|Diagnostic Test|Phase-1: Breath Holding Test|In this phase of the study, each subject will be asked to hold their breath for up to 60 seconds or until they can longer hold it. While they are holding their breath, subjects will be hooked up to a monitor that will measure their Peripheral oxygen saturation (SpO2) respiratory rate (RR), and heart rate (HR).
15738648|NCT04954157|Diagnostic Test|Phase 2: 6-Minute Walk Test (6MWT)|In this phase of the study, each subject will be asked to walk for 6 minutes in their hospital room or hallway. Their rate of perceived exertion will be measured while also hooked up to a monitor that will measure their Peripheral oxygen saturation (SpO2) respiratory rate (RR), and heart rate (HR).
15738649|NCT04954144|Device|Leap Motion Sensor|As a virtual reality treatment method, leap motion sensor was integrated with laptop computer and participants played object capture, firefly, bee-batting games to improve performance based hand skills.
15738650|NCT04954144|Other|Neurodevelopmental Treatment Approach|It is a method that tries to control sensorimotor components of muscle tone, reflexes, abnormal movement patterns, postural control, sensory-perception and memory problems with special techniques.
15738651|NCT04954131|Biological|Candidate Vaccine, SCB-2019|30 μg of SCB-2019 antigen, and 1.5 mg CpG 1018 and 0.75 mg Alhydrogel as adjuvants
15738653|NCT04954118|Procedure|Internal jugular vein cannulation|The clinicians performed an internal jugular vein cannulation using personal protective equipment (PPE) or both of the aerosol box and PPE provide insertion of a central venous catheter in COVID-19 patients.
15738654|NCT04954092|Biological|Gam-COVID-vac M|The vaccine consists of two components: component I and component II. Component I includes a recombinant adenoviral vector based on human adenovirus serotype 26 carrying the gene for the S-protein of the SARS-CoV-2 virus, component II includes a vector based on human adenovirus serotype 5 carrying the protein S gene of the SARS-CoV-2 virus
15738655|NCT04954092|Biological|Placebo|Composition without active ingredients
15738656|NCT04954040|Drug|Hydroxychloroquine Pill + Azithromycin Pill|"Hydroxychloroquine. 1st day 200mg 2-0-2; 2nd to 5th day 200mg 1-0-1 Azithromycin.
~1st day 500m 0-1-0, 2nd to 5th day 250mg 0-1-0"
15738657|NCT04954040|Drug|SOC|Acetaminophen or Metamizole. Antitussives if needed.
15738658|NCT04954027|Behavioral|Questionnaires|"5 visits are planned during the study :
~the inclusion visit : during this visit the patient's non-opposition is obtained and then the patient answer to self-administered questionnaires online
~4 telephone interviews for follow-up by investigator"
15738659|NCT04954014|Drug|Bevacizumab|Patients will receive best available treatment (BAT) for COVID-19 plus a single dose of bevacizumab calculated as 7,5 mg/kg diluted in 250cc of saline solution during 90 minutes.
15738660|NCT04954014|Drug|BAT|Patients will receive best available treatment for COVID-19.
15738661|NCT04954001|Drug|FCN-159|FCN-159 is administered orally in once daily schedule for 28 days a cycle.
15738662|NCT04953988|Procedure|Robotic TKA|Robotic TKA
15738663|NCT04953988|Procedure|Manual operation|Manual operation
15738664|NCT04953962|Drug|CBP501 (16)|16 mg/m2
15738665|NCT04953962|Drug|CBP501 (25)|25 mg/m2
15738666|NCT04953962|Drug|Cisplatin|60mg/m2
15738667|NCT04953962|Drug|Nivolumab|240 mg
15738668|NCT04953949|Device|NU-MAX®|Topical Hemostat
15738669|NCT04953936|Dietary Supplement|HMB-enriched Nutritional Supplements|The participants will receive oral HMB-enriched nutritional supplements (65 g, once daily), which include soybean isolate protein, flaxseed oil powder, yam powder, whey protein, oligomeric isomaltose powder, cocoa powder, medium-chain fatty acid powder, calcium beta-hydroxy-beta-methylbutyrate, sunflower seed oil powder, L-glutamine, wheat germ powder, membrane isolated casein, wheat oligopeptide, konjac flour, vitamin E, vitamin D, stevioside, edible flavors.
15738670|NCT04953936|Dietary Supplement|Placebo|Placebo (maltodextrin 65 g once daily) with the same package as the intervention.
15738671|NCT04953936|Behavioral|Caloric Restrition Diet|Caloric restriction diet with individualized nutritional guidance from professional dietitians by video regarding caloric restriction strategies
15738672|NCT04953923|Drug|Cedazuridine|Tablet for oral administration
15738673|NCT04953923|Drug|Placebo|Capsule for oral administration
15738674|NCT04953923|Drug|Moxifloxacin|Tablet for oral administration
15738675|NCT04953910|Drug|ASTX727|Multiple-dose oral administration of once-daily decitabine (35 mg) and cedazuridine (100 mg)
15738676|NCT04953897|Drug|ASTX727|Multiple-dose oral administration of once-daily decitabine (35 mg) and cedazuridine (100 mg)
15738677|NCT04953884|Drug|wilate|wilate is a plasma-derived, stable, highly purified, double virus inactivated concentrate of freeze-dried active VWF and factor VIII (FVIII) prepared from cryoprecipitate and intended for the treatment of patients with von Willebrand disease (VWD) and/or haemophilia A
15738678|NCT04953871|Drug|TNF Inhibitor|TNF inhibitors are widely used in patients with spondyloarthritis
15738679|NCT04953858|Other|Social network strategy (SNS)|SNS utilizes peers to reach and recruit their network members into HIV services, therefore having the advantage that recruiters with different behavioral risks and HIV statuses are likely to have access to a wide variety of HIV at risk populations
15738680|NCT04953832|Behavioral|Cognitive Training|Participants are asked to remember a series of items while solving puzzles.
15738681|NCT04953819|Other|Revascularization|Percutaneous coronary intervention and/or coronary bypass grafting for coronary artery disease
15738682|NCT04953819|Other|Medical therapy|Optimal medical therapy for coronary artery disease
15738683|NCT04953806|Behavioral|Step-CBT|Participants will complete Step-CBT, an integrative 12-week physical activity and cognitive behavioral therapy (CBT) intervention, delivered by a licensed clinical psychologist. Sessions will take place once per week for 60 minutes using VA Video Connect. Each session will include core components 1) Reviewing physical activity goals, prescribing new step count goal, and problem-solving barriers and 2) The weekly CBT intervention module.
15738684|NCT04953793|Behavioral|TAY SUCCESS|TAY SUCCESS stands for transition age youth supported, comprehensive cognitive enhancement and social skills. The cognitive-behavioral intervention teaches a number of strategies for executive functioning, social cognitive functioning and social communication.
15738685|NCT04953793|Other|Usual Care|Usual care involved the typical vocational supportive education program delivered in the educational setting
15738686|NCT04953780|Drug|Calaspargase pegol-mknl|Calaspargase pegol-mknl
15738687|NCT04953767|Device|Blue light therapy|Blue light therapy has been proved its efficacy and safety is treatment circadian rhythm disorder as well as other diseases.
15738688|NCT04953767|Other|White light|White light is used as sham control.
15738689|NCT04953754|Dietary Supplement|Melatonin|The melatonin group will receive 5mg melatonin nightly
15738690|NCT04953754|Device|Phillips Actiwatch Spectrum Plus|Both groups will be monitored by the FDA-cleared Actigraph
15738691|NCT04953741|Drug|Fluticasone propionate inhaled aerosol|The study consists of two stages and include three groups. Three groups include: Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped Fluticasone propionate Inhaled Aerosol and continuation of montelukast once a day; Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug once a day; Stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug twice daily, and then Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day. The scheme of every group is divided into two stages. Only those whose asthma are well controlled at the end of the first phase will be allowed to proceed to the next phase.
15738692|NCT04953728|Device|Transcutaneous Electrical Acustimulation (TEA)|Each participant will undergo 5 sessions total at two different frequencies (25 Hz and 100Hz) with electrodes placed at two different locations (wrist and knee) and a placebo session.
15738693|NCT04953715|Other|collection of body microbioma|A prospective, observational microbiome study of adult kidney transplant recipients receiving mycophenolate mofetil and tacrolimus maintenance immunosuppression. Participants will be studied post-transplant for mycophenolate pharmacokinetics and microbiome samples collected. Clinically measured tacrolimus trough concentrations will also be evaluated. Associations among mycophenolic acid enterohepatic recycling and metabolite formation, tacrolimus troughs, immunosuppression adverse effects, diarrhea and microbiome will be studied.
15738694|NCT04953689|Behavioral|Conscientiousness Coach|Participants will use the Conscientiousness Coach app to organize their goals and assist them in engaging in more conscientious behaviors. The participant will also be educated about Conscientiousness as it relates to healthy living and accomplishing life goals and values. Participants will receive brief phone calls during weeks 1, 2, 6, and 10 from the research assistant, tracking progress, answering queries, and return visits to the clinic/teleconference will be scheduled for further assistance during week 4 and week 8. These mid-study visits (or 'Booster Sessions') will last approximately 50 minutes and will involve a brief discussion of goal and value progress and app usage; at this in-person meeting/teleconference, similar questions and topics will be covered as in the bi-monthly phone calls. At week 12, there is a treatment termination visit with the principal investigator and research assistant.
15738695|NCT04953676|Procedure|round tunnel technique|Both the femoral tunnel and tibial tunnel were drilled by 8-mm cannulated drill
15738696|NCT04953676|Procedure|flat tunnel technique|Both the femoral tunnel and tibial tunnel were dimension of 5×11-mm rounded-rectangular, which was created by initially drilling a round tunnel with a 5-mm cannulated drill and reshaped by use of a bone rasp and custom-made dilator.
15738697|NCT04953663|Biological|it-hMSC|Different doses of it-hMSC
15738700|NCT04953637|Other|Physiotherapy|Participants in the physiotherapy group will receive gait and balance focused physiotherapy at One Step Ahead Mobility physiotherapy clinic for 1-hour per day, 3 times/week for 8 weeks.
15738701|NCT04953624|Diagnostic Test|Appetite rating scale CNAQ|Chinese version of Appetite rating scale CNAQ
15738702|NCT04953598|Diagnostic Test|Ultrasonography|Patient undergoes diagnostic ultrasound examination
15738703|NCT04953585|Procedure|radical gastrectomy|According to the size and location of the tumor, the appropriate surgical method was selected for radical gastrectomy
15738704|NCT04953572|Genetic|autologous peripheral blood mesenchymal stem cell|Transplantation of autologous peripheral blood mesenchymal stem cell
15738705|NCT04953572|Procedure|Microfracture|Microfracture
15738706|NCT04953572|Combination Product|Microfracture + collagen membrane|Microfracture plus collagen membrane transplantation
15738707|NCT04953572|Procedure|Autologous osteochondral transplantation|Autologous osteochondral transplantation
15738708|NCT04953559|Device|Active cTBS|Active continuous theta burst (cTBS) transcranial magnetic stimulation (TMS)
15738709|NCT04953559|Device|Sham cTBS|Sham continuous theta burst (cTBS) transcranial magnetic stimulation (TMS)
15738710|NCT04953546|Other|No Intervention|This is an observation study, with no intervention
15738711|NCT04953533|Other|no intervention|
15738712|NCT04953520|Procedure|ultrasound-CT fusion imaging|The patient undergoes lumbar nerve root block guided puncture needle placement under the guidance of ultrasound-CT fusion imaging
15738713|NCT04953520|Procedure|pure ultrasound guidance|The patient undergoes lumbar nerve root block guided puncture needle placement under the guidance of pure ultrasound guidance
15738714|NCT04953507|Procedure|Thermal Radiofrequency|Radiofrequency lesioning at level of T2, T3 using 80°c for 60-90 seconds
15738715|NCT04953507|Procedure|Chemical Neurolysis|injection of 2 to 3 ml of the chemical neurolytic agent (phenol in glycerin 6%)
15738716|NCT04953494|Diagnostic Test|Patient information collection, exon sequencing and follow-up.|Clinical baseline data, disease characteristics, auxiliary examination results, EMG examination results, drug use and other information were collected. 4-6ml peripheral blood was collected for exon sequencing. The patients were followed up every three months by a specialist in the form of outpatient or telephone.
15738717|NCT04953481|Other|survey|The general information, home care status and functional status of ALS patients and family caregivers were collected.
15738718|NCT04953468|Diagnostic Test|expression level of ANXA2 protein|The expression level of ANXA2 protein in glioma and PTBE was detected by immunohistochemistry
15738719|NCT04953455|Other|no intervention|no intervention
15738720|NCT04953442|Behavioral|Fit 24|This 12-week goal-setting intervention will test the feasibility of using a Fitbit watch and motivational text messaging to improve physical activity and sleep in Hispanic youth (14-16 years of age) with obesity. Youth will be prompted to set weekly steps per day and hours of sleep per night goals. Text messages will be grounded in the Self-Determination Theory and will provide evidence-based strategies, support, and motivation to encourage youth to meet their goals.
15738721|NCT04953429|Behavioral|workload|Mental needs, physical needs, time needs, self performance, effort, frustration, technical autonomy, decision-making autonomy and work needs of nursing work
15738722|NCT04953416|Device|1565nm non ablative fractional laser|The ResurFX module contains Erbium:Glass Fiber Laser Technology with wavelength of 1565 nm, which is transferred to the ResurFX handpiece via a fiber.
15738723|NCT04953390|Device|Hearing Aid|Commercially available hearing aid with different microphone directionality settings
15739169|NCT04949451|Dietary Supplement|Whey protein supplement|Participants consume whey protein at the beginning of the eating period.
15738725|NCT04953364|Behavioral|SMART|SMART includes mental and physical wellness, residual/prosthetic limb managements, use of a prosthesis and weekly peer-support calls or video call over Zoom, hosted by University of British Columbia, depends on participant's preference, promoting motivation and establishing goal setting and action planning. The tablet will also allow asynchronous contact with trainers through a secure website.
15738726|NCT04953364|Behavioral|Control|The control group will receive a care booklet and weekly contacts.
15738727|NCT04953351|Procedure|Cognitive registration targeted biopsy and TRUS-system biopsy|Cognitive registration is a visual guidance technique in which the surgeon samples a visually estimated location on ultrasound that corresponds to the MRI suspicious regions location. TRUS-system biopsy includes 12 biopsy cores.
15738728|NCT04953351|Procedure|MRI-ultrasound fusion targeted biopsy and TRUS-system biopsy|MRI-ultrasound fusion targeted biopsy is conducted with an mpMRI-TRUS biopsy system that provides realtime fusion of TRUS images and MRI images to guide the biopsy needles. TRUS-system biopsy includes 12 biopsy cores.
15738729|NCT04953338|Other|Exposure of mental health condtion of interest|Common mental health conditions consist of depressive episodes, recurrent depressive disorder and anxiety disorder.
15738730|NCT04953325|Biological|Inactivated COVID-19 Vaccine|600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection
15738731|NCT04953325|Biological|23-valent pneumococcal polysaccharide vaccine|25μg each of the following serotypes/each dose (0.5ml): 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F
15738732|NCT04953325|Biological|Inactivated Hepatitis A Vaccine|500SU inactivated Hepatitis A virus in 1 mL of aluminium hydroxide solution per injection.
15738733|NCT04953312|Biological|Blood samples|blood
15738734|NCT04953299|Behavioral|Functional Imagery training|Behavioural intervention focused upon motivation and reaching achievable goals.
15738735|NCT04953299|Behavioral|NHS 12 week weight loss programme|The plan is designed to help individuals lose weight at a safe rate of 0.5kg to 1kg (1lb to 2lb) each week by sticking to a daily calorie allowance and introducing exercise.
15738736|NCT04953286|Other|Measure of visual acuity|ETDRS and Parinaud scale
15738737|NCT04953286|Other|Interferometry|Non-contact exam measuring N.I.B.U.T (Non-invasive break-up time), quantitative and qualitative evaluation of the meibomian glands and quantitative evaluation of the tear meniscus
15738738|NCT04953286|Other|Samples of basal tears|Collection of basal tears without instillation of anesthetic with a Schirmer strip for 5 minutes and by microcapillary
15738739|NCT04953286|Other|Central corneal sensitivity|Central corneal sensitivity using a Cochet-Bonnet esthesiometer (Luneau©)
15738740|NCT04953286|Other|Slit lamp examination and undilated fundus|Slit lamp examination and undilated fundus
15738741|NCT04953286|Other|Conjunctival impression|Conjunctival impression with anesthetic instillation
15738742|NCT04953286|Other|Evaluation of the corneal innervation|Contact corneal confocal microscopy
15738743|NCT04953273|Other|Vigitrauma|Case management algorithm using early phone contact
15738744|NCT04953260|Other|APRF|20ml venous blood was collected from the elbow before operation and centrifuged with a special centrifuge. One piece of APRF gel was chopped and mixed with Bio-oss, and the other piece was pressed into a thin film; the mixture of APRF and Bio-oss was filled into the bone defect, covered with a properly trimmed Bio-gide film, and then covered with APRF film
15738745|NCT04953260|Other|CGF|20ml venous blood was collected from the elbow before operation and centrifuged with a special centrifuge. One piece of CGF gel was chopped and mixed with Bio-oss, and the other piece was pressed into a thin film; the mixture of CGF and Bio-oss was filled into the bone defect, covered with a properly trimmed Bio-gide film, and then covered with CGF film
15738746|NCT04953234|Device|NovoTTF-100L|Patients receive continuous TTFields treatment using the NovoTTF-100L device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the thorax. The treatment enables the patient to maintain regular daily routine.
15738747|NCT04953221|Drug|YJ001|Skin spray
15738748|NCT04953208|Device|active tDCS|Treatment will be applied daily 5 days/week for a period of 6 weeks, which equals a tDCS stimulation for a total of 30 treatment sessions. Every treatment session consists of 30 minutes of intervention.
15738749|NCT04953208|Device|sham tDCS|sham stimulation for a total of 30 treatment sessions. Every treatment session consists of 30 minutes of intervention.
15738750|NCT04953208|Behavioral|cognitive and emotional control video game|a video game targeting cognitive and emotional control. total of 30 treatment sessions. Every treatment session consists of 30 minutes of intervention.
15738751|NCT04953208|Behavioral|sham video game|a video game which does not target cognitive control, played for total of 30 treatment sessions. Every treatment session consists of 30 minutes of intervention.
15738752|NCT04953195|Drug|Levothyroxine Sodium Tablets|Levothyroxine Sodium(50ug/Tablets,dosage form 25ug,once a day) was administered to patients with autoimmune thyroiditis with mild subclinical hypothyroidism,
15738753|NCT04953182|Other|Pain scale registry|The nurses ask the patient about the pain filling every two hours during the hospitalization.
15738754|NCT04953169|Other|Biobank Video|The video describes the process of biobanking with visuals
15738755|NCT04953169|Other|Non-Video|The non-video group will receive a written informed consent
15738756|NCT04953156|Drug|Nitroglycerin|data will be retrieved from intraoperative medical records for the period from May 2020 to May 2021 for patients meeting the eligibility criteria who developed uncontrolled elevation of their blood pressure and received nitroglycerine infusion
15738757|NCT04953156|Drug|Dexmedetomidine|All patients who develop uncontrolled elevation of their blood pressure and meeting the eligibility criteria from July 2021 to July 2022 will receive dexmedetomidine bolus of 1mic/kg over 20 minutes and then continuous infusion of 0.2-0.7 mic/kg/hour adjusted according to each patient hemodynamic response.
15738758|NCT04953143|Behavioral|LiverPal Intervention|"Inpatient longitudinal palliative care intervention
~- Patients will complete baseline assessments and will be followed by the palliative care clinicians delivering the LiverPal intervention during each of their hospitalizations over a 3 month period
~LiverPal intervention domains include the following:
~Therapeutic relationship
~Symptom management
~Coping with illness
~Prognostic awareness and illness understanding
~Treatment decision-making
~End-of-life care"
15739170|NCT04949451|Dietary Supplement|Ketogenic aid|Participants consume ketogenic aid upon waking.
15738759|NCT04953130|Biological|Gardasil® HPV vaccine|Single dose 4-valent HPV vaccine in males. Gardasil®, manufactured by MSD, consists of a licensed prophylactic virus-like particle (VLP) vaccine that protects against 4 HPV genotypes (HPV 6, 11, 16, 18).
15738760|NCT04953117|Device|DCB of Lepu Medical(dimeter≥2.00 mm)|subjects receiving DCB of Lepu Medical(dimeter≥2.00 mm)
15738761|NCT04953117|Device|Restore DEB|subjects receiving Restore DEB
15738762|NCT04953117|Device|DCB of Lepu Medical(dimeter<2.00 mm)|subjects receiving DCB of Lepu Medical(dimeter<2.00 mm)
15738763|NCT04953104|Other|Diagnostic Laboratory Biomarker Analysis|Correlative studies
15738764|NCT04953104|Biological|Nivolumab|Given IV
15738765|NCT04953078|Biological|Baiya SARS-CoV-2 Vax 1|Intramuscular injection in the deltoid region of 0.5 mL/dose of Baiya SARS-CoV-2 Vax 1 (recombinant SARS-CoV-2 receptor-binding domain fused with FC region of human IgG1 vaccine)
15738766|NCT04953065|Other|COVID-19 vaccine hesitancy and acceptance survey|Participants will be provided with a COVID-19 vaccine hesitancy and acceptance survey developed by the study team.
15738769|NCT04953026|Diagnostic Test|Diagnositic test|The results of shoulder arthroscopy were taken as the gold standard, and MRI examination was taken as the research object.
15738770|NCT04953013|Drug|sodium bicarbonate|Drug exposure
15738771|NCT04952987|Drug|Diquafosol|Diquafosol (Diquas) is a P2Y2 receptor agonist which improves mucin and tear secretion
15738772|NCT04952961|Behavioral|Training in Vulval Self-Examination|Face-to-face training in vulval self-examination Supplemented with use of aids ( hand mirror, mobile phone with selfie-stick), patient information leaflet, reminders to self-examine
15738773|NCT04952948|Other|PILATES Training|During the PILATES sessions, the practitioner received orientations to to perform slow movements, aware, and combined with the respiratory cycle. The exercises program was performed on a soft ground covered with tatamis. During the program, a set of swiss balls of 45, 55, and 65 cm in size and elastic bands of very moderate resistance were used. Each exercise session was divided into 3 stages, namely (a) global initial static and dynamic stretching (10 minutes); (b) general conditioning (45 minutes) and; (c) relaxation (5 minutes). The amount of series and repetitions per set in exercises, in addition to the intensity required in each session in PILATES is presented in Table 2 of Melo et al. (2020) - Vide reference.
15738774|NCT04952935|Procedure|True Acupuncture|Delivery of four acupuncture seeds (no needles involved) to the head and neck area at true acupuncture points.
15738775|NCT04952935|Procedure|Sham Acupuncture|Delivery of four acupuncture seeds (no needles involved) to the head and neck area at non-acupuncture points.
15738776|NCT04952922|Other|Treatment for recurrent oropharyngeal cancer (curative/ palliative)|Open salvage surgery, transoral robotic surgery, palliative chemotherapy, immunotherapy.
15738777|NCT04952909|Device|ShortCut™|Splitting bioprosthetic aortic valve leaflets
15738778|NCT04952896|Diagnostic Test|Patient Comprehensive Rating Scale|Patient subjective rating scale
15738779|NCT04952870|Other|Inhaled NO|Newborn or young infants (< 3 months) receiving inhaled NO as part of their treatment for severe respiratory failure
15738780|NCT04952870|Other|routine care|Patients treated for respiratory failure
15738781|NCT04952857|Drug|cholecalciferol 6 lakh IU|vitamin D levels and serum calcium will be assessed at day 3,7, 14.
15738782|NCT04952831|Other|diffusion MRI (dMRI)|All participants underwent dMRI scan at baseline
15738783|NCT04952818|Diagnostic Test|RANK/RANKL(RANK: Receptor Activator of Nuclear factor Kappa-Β /RANKL:Receptor Activator of Nuclear factor Kappa-Β Ligand)|Immunohistochemical staining was performed using the following antibodies: anti-RANK antibody from Bioss Company (No.bs-2695R) and anti-RANKL antibody from Abcam (No.ab222215).
15738784|NCT04952805|Drug|MAD0004J08|MAD0004J08 is a human monoclonal Antibody (mAb), 2.5 mL 2R vial available in two dose: 100 mg and 400 mg. The pharmaceutical form is solution for intramuscular injection.
15738785|NCT04952805|Other|Placebo|Placebo matching to MAD0004J08, 2.5 mL 2R vial. The pharmaceutical form is solution for intramuscular injection.
15738786|NCT04952792|Drug|Apixaban 2.5 milligram Oral Tablet|Apixaban 2.5mg/12h, oral, 28 days
15738787|NCT04952779|Drug|Xultophy® (insulin degludec/liraglutide)|"Xultophy® is a fixed ratio combination of the long-acting basal insulin, insulin degludec, and the glucagon-like peptide 1 receptor agonist (GLP-1 RA), liraglutide, administered under the skin.
~Patients will be treated according to routine clinical practice at the discretion of the treating physician according to the label approved by MFDS.
~The assignment of the patient to Xultophy® is not decided in advance by the protocol but falls within current practice and the prescription of Xultophy® is clearly separated from the decision to include the patient in the study."
15738788|NCT04952766|Biological|Biological samples|"Immunocompromised subjects and healthy subjects groups will have collection of biological samples (blood with/without nasopharyngeal swabs) at Month-0, -1, -2, -3, -6, with associated data for the study of the kinetics of antibodies anti COVID-19.
~Biological samples :
~Serum and plasma from each participant for the purpose of performing the SARS-CoV-2 serologic tests
~Nasopharyngeal samples (not mandatory)
~Associated data :
~Demographic data
~Description of clinical manifestations related to vaccination
~Description of clinical manifestations related to SARS-CoV-2 infection, if any Blood Fractioning
~Serum and plasma aliquoted and stored under 250, 500 and 1000 µL (at -80°C)"
15738789|NCT04952753|Drug|NIS793|Investigational drug NIS793 will be administered intravenously (IV) at the dose and schedule determined in the safety run-in part.
15738790|NCT04952753|Drug|Bevacizumab|Bevacizumab will be administered IV
15738791|NCT04952753|Drug|Modified FOLFOX6|5-fluorouracil [continuous infusion], leucovorin [administered IV] (or levoleucovorin [administered IV]), and oxaliplatin [administered IV]
15738792|NCT04952753|Drug|FOLFIRI|5-fluorouracil [continuous infusion], leucovorin [administered IV] (or levoleucovorin [administered IV]), and irinotecan [administered IV]
15738793|NCT04952740|Procedure|IPC+PCI|Routine PCI operations (including thrombus aspiration, stent injection, application of GPIIb/IIIa, etc.) + immediate post-ischemic adaptation: 30 seconds balloon inflation and 30 seconds deflation for 3 cycles
15738794|NCT04952740|Procedure|No IPC|Routine PCI operations (including thrombus aspiration, stent injection, application of GPIIb/IIIa, etc.
15739171|NCT04949451|Other|Control group - time restricted feeding only|Time restricted feeding.
15738795|NCT04952727|Biological|Recombinant SARS-CoV-2 Ad5 vectored vaccine|This vaccine contains 5×10^10 virus particles of recombinant replication defective human type 5 adenovirus expressing SARS-CoV-2 S protein, which is produced by CanSino Biologics Inc. It is a liquid dosage form, 0.5 ml / bottle.
15738796|NCT04952727|Biological|Inactive SARS-CoV-2 vaccine (Vero cell)|This vaccine contains 600 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research & Development Co., Ltd. 0.5 ml / bottle.
15738797|NCT04952714|Device|Oxiris|Through a previously established and standardized management protocol, the treating team will prescribe renal replacement therapy by hemodiafiltration (CVVHDF) in the PrismaFlex device, at a dose of 25 mL / Kg of PrismaSate dialysis solutio and the removal filter oXiris® cytokines (Baxter) vs. the standard filter.
15738798|NCT04952701|Device|Control lenses|Control Multifocal lenses
15738799|NCT04952701|Device|Test lenses|Test Multifocal lenses
15738800|NCT04952688|Other|OCT- Angiographie|Ophthalmological examinations
15738801|NCT04952662|Genetic|Genetic variants|COL1A1 rs1800012, COL1A2 rs412777, COL5A1 rs12722, ACTN3 rs1815739, ACE rs1799752, ESR1 rs2234693, MMP3 rs679620, VDR rs2228570 and GDF5 rs143383
15738802|NCT04952636|Procedure|arthroscopic Cuistow|peforming the Cuistow Procedure under arthroscopy
15738803|NCT04952636|Procedure|open Cuistow|peforming the Cuistow Procedure with the traditional open process
15738804|NCT04952623|Other|Rotator Cuff Related Shoulder Pain E-Learning Program|The RCRSP e-learning program is designed according to the ADDIE Instructional Design Model in light of current literature.
15738805|NCT04952610|Drug|Etripamil NS 70 mg|Etripamil will be administered via the Aptar Pharma Nasal Spray Bidose System.
15738806|NCT04952610|Device|Aptar Pharma Nasal Spray Bidose System|Aptar Pharma Nasal Spray Bidose System will be supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.
15738807|NCT04952597|Drug|Ociperlimab|Ociperlimab is a monoclonal antibody formulated for intravenous injection.
15738808|NCT04952597|Drug|Tislelizumab|Tislelizumab is a monoclonal antibody formulated for intravenous injection.
15738809|NCT04952597|Drug|Concurrent Chemoradiotherapy|Cisplatin and carboplatin, intravenous therapy
15738810|NCT04952584|Biological|CD30.CAR-EBVST cells|"The dose is based on the number of CD30.CAR-expressing cells. In our previous study the highest dose was 2 × 10^8 cells/m2 and we did not reach a MTD.
~There will be a gap of 4 weeks between the first and second patient on each dose level.
~On Day 0 of study, patients will receive their planned single dose of investigational T cell product by IV infusion over approximately 1 to 10 minutes in an expected volume of 1 to 50 mL."
15738811|NCT04952571|Drug|Camrelizumab and Bevacizumab|"Stage 1: Targeted therapy induction phase: bevacizumab 5mg/kg, intravenous infusion, once every two weeks, 2 cycles in total.
~Phase 2: Targeted combined immunotherapy: once every three weeks with the following drugs: (1) bevacizumab 7.5mg/kg intravenously;(2) Carrelizumab: 200mg/ time, intravenous infusion."
15738812|NCT04952545|Drug|ALXN2050|Oral tablet.
15738813|NCT04952545|Drug|Placebo|Oral tablet.
15738815|NCT04952519|Drug|Amantadine|Patients are treated with high doses of amantadine.
15738816|NCT04952506|Drug|CKD-349 F1 Tab.|1T Single does
15738817|NCT04952506|Drug|CKD-349 F2 Tab.|1T Single does
15738818|NCT04952506|Drug|D113 Tab.|1T Single does
15738819|NCT04952493|Drug|Anlotinib hydrochloride|Anlotinib hydrochloride may stop the growth of tumor cells and improve iodine uptake.
15738820|NCT04952493|Drug|Sodium Iodide I 131|RAI treatment may shrink the tumor
15738821|NCT04952480|Radiation|Dose-escalated adaptive radiotherapy|Adaptive planning of Radiation Therapy with two re-plans of the treatment field through course of therapy with the shrinking treatment fields according to tumor response to escalate dose, as allowed by dose to organs-at-risk.
15738822|NCT04952480|Drug|Chemotherapy|Concurrent standard of care platinum doublet based therapy
15738823|NCT04952467|Drug|14C-XEN1101|Subjects will receive a single oral administration of a capsule containing 20 mg XEN1101
15738824|NCT04952454|Procedure|External Dacryocystorhinostomy|The resistance of the lacrimal drainage is lowered by creating a new ostium between the lacrimal sac and nasal cavity via skin incision.
15738825|NCT04952454|Procedure|Endonasal Dacryocystorhinostomy|The resistance of the lacrimal drainage is lowered by creating a new ostium between the lacrimal sac and nasal cavity via endonasal route.
15738826|NCT04952454|Procedure|Transcanalicular Dacryocystorhinostomy|The resistance of the lacrimal drainage is lowered by creating a new ostium between the lacrimal sac and nasal cavity via transcanalicular route.
15738827|NCT04952441|Behavioral|RISE Program|Psychoeducational sessions designed to impact Resilience, Insight, Self-Compassion, and Empowerment
15738828|NCT04952428|Behavioral|"Re-examination visit (today visit)"|"Re-examination visit (today visit) A guidebook will be prepared to standardize procedures throughout the protocol, step by step, for all questionnaires and evidence collection. The data will be transferred to a computerized database.
~The clinician will review with the patient the Information and Medication History Forms and record the anthropometric, socio-demographic and clinical information. Candidates will undergo an oral pathology examination and a full-mouth manual probing using a periodontal probe SONDA PA_ON (Orange Dental®, Aspachstr, Biberach, Germany) to determine their periodontal and peri-implant status. Clinical and radiographic examination will be performed. Moreover, signs as presence of suppuration, bleeding, redness, probing depth must be recorded at 6 sites per implant applying. As well, a specific survey about tobacco habits including modification of Fagestrom & Richmond test will be conducted."
15739212|NCT04949113|Drug|Adjuvant nivolumab|Upfront total lymph node dissection followed by 12 cycles of nivolumab (480mg) every 4 weeks.
15738838|NCT04952363|Device|A vertical vibration platform PowerVibe Zen Pro 5900|Subjects received the interventions twice a week for 8 weeks. HFCWO+WBVT group received additional 30 minutes WBVT treatment. In every WBVT session, three rounds of 3 minutes of vibration (amplitude: 2 mm; frequency: 20 Hz) were provided, with a 60-second rest between rounds.
15738839|NCT04952363|Device|HFCWO|Subjects received the interventions twice a week for 8 weeks. The HFCWO was delivered by a respiratory therapist using a percussive vest at 10-13 Hz oscillating frequency and at a pressure setting of 2 cm H2O. The treatment duration was 25 minutes, and the participants remained in a sitting position.
15738842|NCT04952324|Other|Blood sampling and determination of MTHFR mutation,vitamin B12, folic acid, homocystein and HS CRP|Periferal Blood sampling and determination of MTHFR mutation,vitamin B12, folic acid, homocystein and high sensitive CRP
15738843|NCT04952311|Drug|Tagrelor combined with aspirin|Combination of ticagrelor (first 180mg a day, 90mg/ d, 2 times/d) with aspirin (first 75 to 300mg/ d, 75mg/ d, 2 days/d) for 21 days followed by ticagrelor (90mg/ d, 2 times/d) alone for 3 months
15738844|NCT04952311|Drug|Clopidogrel combined with aspirin|Clopidogrel (first dose 300mg daily, 75mg/ d from day 2) was combined with aspirin (first dose 75-300mg/ d, 75mg/ d from day 2) for 21 days, followed by clopidogrel (75mg/ d) alone for up to 3 months
15738845|NCT04952298|Procedure|Mesial temporal lobe epilepsy surgery|"Medial temporal lobe epilepsy surgery including
~selective Amygdalohippocempectomy (SAH) including anterior parahippocampal gyrus / entorhinal cortex
~anteromedial temporal lobe resection including amygdalohippocampectomy
~anterior temporal lobe resection"
15738846|NCT04952272|Combination Product|CpG-ODN|CAR-T cells secreting scFv against OX40
15738847|NCT04952259|Drug|Shexiang Tongxin Dropping Pills + routine treatment|oral+percutaneous coronary intervention
15738848|NCT04952259|Procedure|routine treatment|percutaneous coronary intervention
15738849|NCT04952220|Device|ultrasound|Describe the sonographic abnormalities observed at Day 0, Day 10, 6 weeks, 3 months, 6 months, during native septic arthritis of the knee
15738850|NCT04952207|Drug|Direct-acting antiviral agents|The initial DAA treatment and its dose for all patients is determined by the infectionist or hepatologist based on the clinical diagnosis and treatment routine. The administration dose in the instructions for use for current DAAs marketed in China Mainland unnecessary to combine with any IFN is shown but not limited as follows: Sofosbuvir, Ombitasvir/Paritaprevir/Ritonavir, Dasabuvir, Daclatasvir, Asunaprevir, Elbasvir/Grazoprevir, Sofosbuvir/Velpatasvir and Ledipasvir/Sofosbuvir.
15738851|NCT04952194|Drug|Stalevo|The dose of Stalevo initially ranges from (Levodopa/Carbidopa/Entacapone) 50/12.5/200 mg 3 times a day to a target dose of 100/25/200 mg 5 times a day, with an interval of 3 hours. No other anti-Parkinson's disease drugs are added.
15738852|NCT04952194|Drug|Carbidopa and Levodopa Controlled Release Tablets|The dose of Carbidopa and Levodopa Controlled Release Tablets initially ranges from (Levodopa/Carbidopa) 50/12.5mg 3 times a day to a target dose of 100/25 mg 5 times a day, with an interval of 3 hours. No other anti-Parkinson's disease drugs are added.
15738853|NCT04952181|Device|optical biometry|optical biometry is a fast, noncontact method it uses the method of partial coherence interferometry (PCI) to measure the axial length (AXL), based on reflection of the interference signal of the retinal pigment epithelium.
15738854|NCT04952181|Device|ultrasonic biometry|ultrasonic biometry is contact method depends on ultrasonic transducer producing thin sound beam travelling through different media of the eye when it faces interface of substance dissimilar from that it is travelling through part is reflecting and the other travel through the different substance
15738855|NCT04952168|Drug|Almonertinib|All patients were treated with Almonertinib 110 mg once a day for 3 months. Patients evaluated as CR, PR and SD were given concurrent chemoradiotherapy. The dose of radiotherapy was 60-66Gy/30-33F, After the end of concurrent chemoradiotherapy, the patients were treated with 110 mg of ametinib once a day until the disease progressed or the side effects were intolerable.
15738856|NCT04952155|Drug|IL-2|The administration period was divided into 6 courses. 6 cycles of IL-2 were administered subcutaneously at a dose of 1 million IU every other day for 2 weeks, followed by a 2-week break in treatment. The adminstration course was 24 weeks.. The 24-week follow-up period was followed after the treatment.
15738857|NCT04952142|Other|minimal water exchange|Use a new technique, minimal water exchange colonoscopy, which adds the infusion of modest amounts of water by constant pressure on the air-water valve button of the endoscope to achieve intubation.
15738858|NCT04952129|Drug|Selenomethionine|Seleno-amino acid
15738859|NCT04952129|Drug|Methylselenocysteine|Seleno-amino acid
15740815|NCT04935788|Dietary Supplement|micellar casein|micellar casein supplement
15738861|NCT04952103|Other|no intervention|The patient's treatment is determined by the physician in charge according to the patient's clinical situation and relevant guidelines, without additional intervention.
15738862|NCT04952077|Device|MRI|Magnetic Resonance Imaging (MRI)
15738863|NCT04952064|Drug|Monosialoganglioside GM1|Monosialoganglioside GM1 diluted with 0.9% normal saline 100ml, iv, daily for 12-14 days
15738864|NCT04952051|Drug|Enalapril Folic Acid Tablets Combined With amlodipine|Enalapril Folic Acid Tablets 10.8mg Combined With amlodipine 5 or 10mg
15738865|NCT04952051|Drug|Enalapril Folic Acid Tablets Combined With hydrochlorothiazide|Enalapril Folic Acid Tablets 10.8mg Combined With hydrochlorothiazide 12.5 or 25mg
15738866|NCT04952038|Behavioral|sleep disorder|ALS patients with or without sleep disorder
15738867|NCT04952025|Diagnostic Test|Diagnostic criteria|Diagnostic criteria of ALS
15738868|NCT04952012|Drug|LT4|LT4 is used to improve the thyroid function of pregnant women.
15738869|NCT04951999|Other|Blood sampling|For 10 visits (out of the 12 of the protocol), ~40 ml of blood is sampled for research purposes in addition to care sampling.
15738870|NCT04951986|Drug|Rifampin|Rifampicin up to 35 mg/kg/day for 14 days
15738871|NCT04951986|Drug|Levofloxacin|Levofloxacin 750mg daily (for weight <50kg) or 1 g daily (for weight >50 kg) daily for 14 days
15738872|NCT04951986|Drug|Rifampicin, Pyrazinamide, Ethambutol and Isoniazid|Rifampicin 10 mg/kg; Isoniazid 5 mg/kg; Pyrazinamide 15 mg/kg; Ethambutol15 mg/kg in fixed dose combination administered per weight band. Standard of care control arm
15738873|NCT04951986|Drug|Prednisone|Prednisone 1.5mg/kg/day for 14 days
15738874|NCT04951986|Drug|Placebo|Placebo identical to Prednisone
15738875|NCT04951973|Diagnostic Test|Deep Learning Based Early Warning Score (DEWS)|DEWS use 4 vital signs (systolic blood pressure, HR, respiratory rate, and body temperature) to predict in-hospital cardiac arrest. Deep-learning approach facilitates learning the relationship between the vital signs and cardiac arrest to achieve the high sensitivity and low false-alarm rate of the track-and-trigger system (TTS).
15738876|NCT04951960|Other|Higher PEEP setting|PEEP levels are determined according to the higher PEEP-FiO2 tables set plateau pressure less than 30 cmH2O. The duration of measurement at each PEEP levels is 1 hour.
15738877|NCT04951960|Other|Lower PEEP setting|PEEP levels are determined according to the lower PEEP-FiO2 tables set plateau pressure less than 30 cmH2O. The duration of measurement at each PEEP levels is 1 hour.
15738878|NCT04951947|Drug|JS201 combine with Lenvatinib|JS201 300mg i.v Q2wLenvatinib 8mg po. Qd
15738879|NCT04951934|Device|EmoLED|This treatment consists of irradiation with the blue light emitted by the device for one minute on the injured area. If the wound has a greater extension than the irradiated area, multiple repeated applications will be performed on adjacent areas, until the entire wound is covered.
15738880|NCT04951934|Procedure|Standard treatment|"The standard treatment consists of: cleansing and possible debridement of the wound, application of the topical treatment indicated for that phase of the wound, intended as the standard of care of the structure, and subsequent bandaging."
15738881|NCT04951921|Drug|Hyperpolarized 13C Pyruvate|Procedure: Magnetic Resonance Imaging Undergo 1H-MRI of DWI/MRF/CEST for tumor cite following by 13C DNP-MRI for spleen for 3-5 minutes after hyperpolarized 13C pyruvate injection
15738882|NCT04951908|Diagnostic Test|MRI|MRI of TMJ
15738883|NCT04951895|Diagnostic Test|MRI|MRI of TMJ
15738884|NCT04951882|Biological|human derived umbilical cord derived mesenchymal stem cells|intravenous transplantation of human derived umbilical cord derived mesenchymal stem cells
15738885|NCT04951869|Drug|Protescal gel|Protescal gel (0.5 mL) was again applied over the subcutaneous tissue prior to skin closure in Protescal group
15738886|NCT04951856|Drug|Evolocumab 140 MG/ML|Evolocumab (Repatha®) 140 mg every two weeks: first subcutaneous injection at the time of randomization, before PCI, followings during 12 months.
15738887|NCT04951856|Drug|Standard of care (SOC)|management as recommended in ESC/EAS 2019 guidelines, within reimbursement criteria
15738888|NCT04951843|Dietary Supplement|Black soybean koji product|Black soybean koji product
15738889|NCT04951830|Diagnostic Test|MRI|MRI of TMJ
15738890|NCT04951817|Drug|Ga-68 PSMA ligand|For PET/CT PSMA scan, the subject will have catheter(s) placed for intravenous administration of [68Ga]PSMA-11. Subjects will receive a single intravenous bolus of 2-5 mCi [68Ga]PSMA-11 and received PET/CT scan 60 minutes later.PSMA PET-CT scan was performed on a GE Discovery MI PET/CT system.
15738891|NCT04951804|Procedure|EUS-CPN without bupivacaine|Under conscious sedation, an echoendoscope is advanced into the stomach, just distal to the gastro-esophageal junction. The region of the celiac plexus is identified around the takeoff of the celiac artery from the aorta. Then, under real-time ultrasound guidance, a 19g needle is used to inject a neurolytic agent such as absolute alcohol around the base of the celiac artery.
15738892|NCT04951804|Procedure|EUS-CPN with bupivacaine|Under conscious sedation, an echoendoscope is advanced into the stomach, just distal to the gastro-esophageal junction. The region of the celiac plexus is identified around the takeoff of the celiac artery from the aorta. Then, under real-time ultrasound guidance, a 19g needle is used to firstly inject bupivacaine and secondly a neurolytic agent such as absolute alcohol around the base of the celiac artery.
15738893|NCT04951791|Drug|SMOFlipid|will receive intravenous infusion of 2ml\kg of smoflipid 20%, in the internal jugular vein 10 minutes before removal of aortic cross clamp in a constant speed
15738894|NCT04951791|Other|Normal saline 0.9%|will receive intravenous infusion of 2ml\kg of normal saline 0.9%, in the internal jugular vein 10 minutes before removal of aortic cross clamp in a constant speed.
15738895|NCT04951778|Drug|CC-91633|Administered orally according to the assigned treatment schedule
15738896|NCT04951765|Drug|XZP-3287|Cycle1 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast
15738897|NCT04951765|Drug|XZP-3287|Cycle1 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 before starting a low-fat breakfast
15738898|NCT04951765|Drug|XZP-3287|Cycle1 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast
15740816|NCT04935788|Dietary Supplement|pea protein|pea protein supplement
15738899|NCT04951765|Drug|XZP-3287|Cycle1 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast
15738900|NCT04951765|Drug|XZP-3287|Cycle1 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle2 Day 1: one dose of XZP-3287 before starting a low-fat breakfast Cycle3 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast
15738901|NCT04951765|Drug|XZP-3287|Cycle1 Day 1: one dose of XZP-3287 after finishing a low-fat breakfast Cycle2 Day 1: one dose of XZP-3287 after finishing a high-fat breakfast Cycle3 Day 1: one dose of XZP-3287 before starting a low-fat breakfast
15738902|NCT04951752|Drug|Ropivacaine injection|Transmuscular quadratus lumborum block - active
15738903|NCT04951739|Procedure|Peroral endoscopic myotomy|Peroral endoscopic myotomy involves an initial incision on the internal lining of the oesophagus. This permits entry of the endoscope to within the wall of the oesophagus, where the muscle will be exposed. The inner layer of the muscle near the lower oesophagal sphincter will be cut (this is termed myotomy). At the conclusion of the procedure, the oesophagal incision will be closed with standard endoscopic clips.
15738904|NCT04951726|Drug|Neostigmine|cholinesterase inhibitor
15738905|NCT04951713|Drug|XZP-3287 combined with clarithromycin|Drug: XZP-3287, oral, 120 mg once daily for day 1 and day 12 Drug: clarithromycin, oral, 500 mg twice daily for day 8 to day 21
15738906|NCT04951713|Drug|XZP-3287 combined with rifampicin|Drug: XZP-3287, oral, 360 mg once daily for day 1 and day 14 Drug: rifampicin, oral, 600 mg once daily for day 8 to day 19
15738907|NCT04951700|Other|Other|This is not an intervention study
15738908|NCT04951687|Dietary Supplement|Ecologic Barrier©|5x10^9 CFU/ 2g per day of Ecologic Barrier©
15738909|NCT04951687|Dietary Supplement|Placebo powder|matched placebo
15738910|NCT04951674|Other|High fiber diet|30 grams of fiber per day
15738911|NCT04951674|Other|Control diet|No diet education and change in diet
15738912|NCT04951661|Device|Virtual Reality|Participants will be set up in the VR equipment. They will engage and follow along with a 10-20 minute guided meditation through the VR. The meditation program may include simulated movement, relaxing music, and the voice of a meditation guide. The research team member will supervise the session, ensuring safety of the subject is maintained.
15738913|NCT04951648|Drug|Almonertinib|Almonertinib 165 mg，orally once a day Treatment can continue until disease progression, unacceptable toxicity or other discontinuation criteria are met.
15738914|NCT04951648|Drug|chemotherapy|Pemetrexed (500mg/m2) plus Carboplatin (AUC5)or Pemetrexed (500mg/m2) plus Cisplatin (75mg/m2) on Day 1 of 21day cycles (every 3 weeks) for 4~6 cycles, followed by pemetrexed mainten-ance therapy every 3 weeks until disease progress-ssion, unacceptable toxicity or other discontinuation criteria are met.
15738915|NCT04951635|Drug|Almonertinib|"The initial dose of Almonertinib 110 mg daily can be reduced to 55 mg daily under specific conditions.
~Treatment can continue until disease progression, unacceptable toxicity or other discontinuation criteria are met. The 2:1 ratio (Almonertinib to placebo)."
15738916|NCT04951635|Drug|Placebo Almonertinib|"The initial dose of Placebo Almonertinib 110 mg daily can be reduced to 55 mg daily under specific conditions.
~Treatment can continue until disease progression, unacceptable toxicity or other discontinuation criteria are met. The 2:1 ratio (Almonertinib to placebo)."
15738917|NCT04951622|Drug|Nipocalimab|Nipocalimab will be administered as an IV infusion.
15738918|NCT04951622|Drug|Placebo|Matching placebo will be administered as an IV infusion.
15738921|NCT04951596|Other|Investigate the current situation|Investigate the current situation of infusion treatment for acute and critical patients in 2 hospitals in the province
15738922|NCT04951583|Combination Product|FMT + ICI|"This study will include 3 cohorts of patients: (1) Patients with advanced or unresectable NSCLC, (2) patients with advanced or unresectable melanoma, and (3) patients with unresectable or advanced uveal melanoma. Patients with NSCLC, melanoma, uveal melanoma and will be analyzed in three separate subgroups given their differing clinical outcomes.
~Each group will be treated with ICI as per their respective first line options, in combination with investigational FMT capsules."
15738923|NCT04951557|Procedure|Transsphenoidal resection|Transsphenoidal resection of pituitary adenoma
15738924|NCT04951544|Other|LetSync v1.0|Study B will entail a pilot randomized, controlled trial (RCT) of an mHealth behavioral intervention, LetSync, with 80 couples (N=160) to assess its acceptability, feasibility, and preliminary impact on retention in care and ART adherence as measured by antiretroviral concentrations in hair. Participants in the intervention arm will use LetSync v1.0 for 6 months and provide acceptability and feasibility data. Participants will then continue to use LetSync v1.0 while the Waitlist-Control group begins to use LetSync v2.0.
15738925|NCT04951544|Other|LetSync v2.0|LetSync v2.0 will be developed by taking feedback from participants regarding LetSync v1.0. Participants in the waitlist-control group will be given LetSync v2.0 to use during the last 6 months of the trial.
15738926|NCT04951531|Procedure|BPTB double-bundle allograft|The patient underwent surgery of arthroscopic double-bundle anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone (BPTB) allograft．
15738927|NCT04951531|Procedure|BPTB single-bundle allograft group|The patient underwent surgery of arthroscopic single-bundle anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone (BPTB) allograft．
15738928|NCT04951531|Procedure|BPTB single-bundle autograft group|The patient underwent surgery of arthroscopic single-bundle anterior cruciate ligament (ACL) reconstruction with bone-patellar tendon-bone (BPTB) autograft．
15738929|NCT04951518|Other|VAN Stroke Scale|V.A.N Stroke Assessment measures unilateral weakness with visual deficits, aphasia, and neglect in possible stroke patients
15738930|NCT04951505|Drug|cefepime-taniborbactam|IV infusion
15738931|NCT04951492|Drug|Olaparib|Given PO
15738966|NCT04951141|Biological|anti-GPC3 CAR-T cells|A single arm, open-label pilot study is designed to determine the safety and efficacy of anti-GPC3 CAR-T cells in patients with GPC3-positive advanced liver cancer.
15738967|NCT04951128|Drug|Tranexamic acid injection|Tranexamic acid (100 mg/mL concentration; 0.5 mL) will be added to local anesthetic mixture of 2% lidocaine with epinephrine (2.25 mL) and 0.5% bupivacaine with epinephrine (2.25mL).
15738932|NCT04951479|Device|Gel-Bead embolization|OptiSphere is FDA approved for the embolization of hypervascular tumors. The product is crosslinked with glutaraldehyde, which improves the mechanical strength of the spheres and provides controlled degradation after implant. The spherical shape provides smooth embolic delivery and even, predictable distribution. In this study the Optispheres will be used for Geniculate artery embolization (GAE) which is a minimally-invasive procedure that has historically been performed for treatment of patients with recurrent knee hemarthrosis. Embolization is a procedure in which material is used to block small blood vessels. Angiogenesis, or growth of new vessels, has been implicated in the initiation and maintenance of joint inflammation. GAE has been applied to patients with moderate osteoarthritis-related pain refractory to maximal medical management with preliminary studies demonstrating a reduction in patient pain.
15738933|NCT04951466|Behavioral|Mindfulness-based therapy for insomnia (MBTI)|Participants randomly assigned to either the MBTI or healthy lifestyle intervention will receive 2 hours weekly session of mindfulness meditation and behavioral sleep strategies for 8 weeks.
15738934|NCT04951466|Behavioral|Healthy lifestyle intervention|Participants randomly assigned to either the MBTI or healthy lifestyle intervention will receive 2 hours weekly session of mindfulness meditation and behavioral sleep strategies for 8 weeks.
15738936|NCT04951440|Drug|Nitrate ketone oxazine|Intervention group: 30min intravenous point. Drop qiu was given 1400 mg of injected sichuan nitrone I bed, and the drug was given 100 mL at day F Set 12 h, and at odds with another 7 days, that is, about 14 times in total.
15738937|NCT04951414|Diagnostic Test|ICF core set|KOA rehabilitation regimen based on the complete core combination of ICF was accepted
15738938|NCT04951401|Other|lipid profile|lipid profile
15738939|NCT04951401|Other|ECG|ECG
15738940|NCT04951388|Biological|MVC-COV1901(S protein with adjuvant)|Approximately 330 participants will receive 2 doses of MVC-COV1901(S-2P protein with adjuvant) at Visit 2 (Day 1) and Visit 4 (Day 29) via intramuscular (IM) injection in the deltoid region
15738941|NCT04951388|Biological|MVC-COV1901(Saline)|Approximately 55 participants will receive 2 doses of MVC-COV1901(Saline) at Visit 2 (Day 1) and Visit 4 (Day 29) via IM injection in the deltoid region
15738942|NCT04951375|Procedure|arthroscopic repair|arthroscopic repair
15738943|NCT04951362|Drug|ivermectin nasal spray|intranasal spray of ivermectin and corticosteroid
15738944|NCT04951349|Drug|GX-03|Same dosage used in Bactroban Nasal studies.
15738945|NCT04951349|Drug|Petrolatum ointment|Viscous ointment similar in form to study drug.
15738947|NCT04951323|Drug|anti-COVID19 mRNA-based vaccine (BNT162b2, Comirnaty®, commercialized by Pfizer)|Participants will receive the COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®). The vaccine is administered intramuscularly after dilution as a series of two doses at least 21 days apart.
15738948|NCT04951310|Behavioral|Philly Vax Sweepstakes|"The Philly Vax Sweepstakes is a citywide sweepstakes designed to motivate Philadelphians to get vaccinated against COVID-19. A total of 36 vaccinated Philadelphians will win among three cash prize packages, distributed from the total cash pool. These 36 will be chosen over three drawings, with 12 residents chosen in each drawing."
15738949|NCT04951297|Other|None, just observation|None ,just observation test
15738950|NCT04951271|Behavioral|Solution focused approach|The SFA intervention consists of seven sessions, one preparation and six solution-oriented sessions. Each session lasted 55 minutes. Filling in the applied scales was excluded from this period. Sessions were held once a week in two groups (Grade 10 and Grade 11 students).
15738951|NCT04951258|Other|Multicomponent exercise|The intervention is a 60-minute session, 3 times/week, totaling 9 weeks. Multicomponent exercise included strengthening, balance training, aerobic dance, and stretching
15738952|NCT04951258|Other|Video home exercise group|The intervention is a 60-minute session, 3 times/week, totaling 9 weeks. Video home exercise included four limbs mobility exercise, stretching, strengthening, and aerobic exercise
15738953|NCT04951245|Procedure|Ultrasound guidance|Initial location of the sentinel lymph nodes identified by ultrasound is performed by the surgeon before surgery. Sentinel lymph nodes are defined according to their anatomical location. The probe was moved from the upper outer quadrant of the breast to the axilla along the lymphatic drainage pathway. After careful examination, the lymph node anatomically closest to the breast in the area from the outer margin of the breast to the lateral edge of the pectoralis minor muscle was detected and marked. A line was drawn as a surgical incision site to identify the marked lymph nodes under ultrasound guidance.
15738954|NCT04951232|Drug|Cinepazide Maleate|The experimental group: guipiprazitel maleate injection (klingo): 320mg (4), dissolved in 500ml of normal saline, and injected in a medium vein at a rate of 100ml/h, once a day, and administered for 14 days.
15738955|NCT04951232|Other|Placebo|Placebo: 4 pieces, dissolved in normal saline 500ml, intravenous drip, the speed is 100ml / h, once a day, continuous administration for 14 days
15738956|NCT04951219|Drug|Resmetirom|Tablet
15738957|NCT04951206|Device|Fractionated CO2-laser|All women will be undergoing FxCO2-laser therapy as this treatment is a criterion for enrollment.
15738958|NCT04951206|Drug|Clobetasol Propionate 0.05% Ointment|Clobetasol propionate 0.05% will be compounded and prepared by a licensed pharmacist using clobetasol propionate powder (micronized, USP; manufactured by Letco Medical, LLC; NDC# 62991-1492-01) combined with base ointment (over-the-counter good neighbor pharmacy petroleum jelly, NDC# 24385-0092-27).
15738959|NCT04951193|Behavioral|Behavioral Activation Therapy app|Goal2QuitVaping focuses on tracking daily activities, recording daily mood, and identifying new activities to complete that may help improve mood. Participants will be asked to complete questionnaire measures weekly for 4 weeks following study enrollment.
15738960|NCT04951193|Behavioral|Treatment as Usual|Participants will be provided educational material about quitting vaping nicotine with the suggestion to discuss questions with their PCP. Participants will be asked to complete questionnaire measures weekly for 4 weeks following study enrollment.
15738961|NCT04951180|Other|Demographic data and MRI images extraction|The data were retrospectively extracted pre- and postoperatively after hip arthroscopy. The prognosis of the surgery was evaluated through MRI images.
15738962|NCT04951167|Drug|Norepinephrine|in the form of infusion
15738963|NCT04951167|Drug|Norepinephrine|in the form of bolus
15756022|NCT04809389|Biological|Matching placebo|0.9% NaCl solution
15738968|NCT04951128|Other|Local anesthetic control|Local anesthetic mixture without tranexamic acid consisting of 2% lidocaine with epinephrine (2.5 mL) and 0.5% bupivacaine with epinephrine (2.5 mL).
15738969|NCT04951115|Drug|Carboplatin|AUC = 5-6 mg/mL per min on Day 1 of each 21-day cycle, for 4 cycles
15738970|NCT04951115|Drug|Cisplatin|75-80 mg/m2 on Day 1 of each 21-day cycle, for 4 cycles
15738971|NCT04951115|Drug|Etoposide|80-100 mg/m2 on Day 1, Day 2, and Day 3 of each 21-day cycle, for 4 cycles
15738972|NCT04951115|Drug|Durvalumab|1500 mg on Day 1 of each 21-day cycle, for 4 cycles. Following this, 1500 mg once every 4 weeks until disease progression
15738973|NCT04951115|Radiation|Stereotactic Body Radiotherapy|6 Gy of radiotherapy targeting multiple sites of intrathoracic disease on Days 1-5 of cycle 1.
15738974|NCT04951102|Behavioral|Electronic Asthma Shared Decision-Making App|The electronic Asthma SDM App will ask questions related to medicine-related, non-medicine-related, and COVID-19-related concerns about patients' asthma, the patients' personal goals for asthma control and expectation for their upcoming visit, and the patients' preferred level of details and involvement in coming to a decision about their asthma treatment. They may also use the Asthma SDM app to find information about asthma, medication management, COVID-19 and COVID-19 vaccines.
15738975|NCT04951102|Behavioral|Shared Decision Making Physician Training Video|Training video to educate physicians on Shared Decision-Making and the use of Shared Decision-Making tools.
15738976|NCT04951102|Behavioral|Electronic Asthma Shared Decision-Making App- Patient Data|Data from the pre-visit electronic Asthma SDM app completed by the patients. Data includes medicine-related, non-medicine-related, and COVID-related concerns about patients' asthma, the patients' personal goals for asthma control and expectation for their upcoming visit, and the patients' preferred level of details and involvement in coming to a decision about their asthma treatment.
15738977|NCT04951102|Behavioral|Standard Care|Standard Care for asthma.
15738978|NCT04951089|Device|i-gel Supraglottic device insertion|i-gel insertion for oxygenation
15738979|NCT04951089|Device|Air- Q SP Supraglottic device insertion|Air-Q SP insertion for oxygenation
15738980|NCT04951076|Drug|BNC210|BNC210 900 mg twice daily (b.i.d.) for 12 weeks
15738981|NCT04951076|Drug|Placebo|Placebo twice daily (b.i.d.) for 12 weeks
15738982|NCT04951063|Drug|Concurrent chemotherapy and single radiation dose climbing|"Dose climbing process:
~The maximum single radiotherapy dose is defined as the maximum dose level at which ≤2 patients have ≥grade 3 toxicity, and ≤1 patient has ≥grade 4 toxicity. If a patient has multiple toxicities, only the highest level toxic event will be recorded.
~When one of the following two conditions are met, it can climb to the next gradient:
~The dose gradient has treated 6 patients, and at least 3 patients have been followed up for more than 3 months after radiotherapy, and no ≥ grade 3 toxicity occurred.
~The dose gradient has treated 6 patients and followed up for more than 3 months after radiotherapy. ≤2 patients had ≥grade 3 toxicity, and ≤1 patient had ≥grade 4 toxicity.
~If 1) and 2) are not satisfied, the enrollment will be terminated.
~Chemotherapy: docetaxel 25 mg/m2 was infused intravenously on D1 of weekly radiotherapy, the infusion time was 1 hour, and cisplatin 25 mg/m2."
15738984|NCT04951037|Behavioral|Fully Asynchronous Online Savvy Program|"The intervention is a fully online, self-administered psychoeducational program designed to enhance caregiver mastery for family and friends providing unpaid care for living with Alzheimer's and similar dementia disorders. Participants will be asked to engage with a fully online version of Tele-Savvy for 42 days.
~Participants will receive a series of daily video lessons related to caregiving. These lessons are generally 8-15 minutes in length and are emailed to participants. Participants can watch the lessons whenever and as often as they wish over the course of the study. There will also be self-guided learning strategies and exercises to accomplish skill and mastery related to the caregiving role. The lessons cover a variety of topics including:
~Facts about dementing Illnesses
~Caregiving Strategies - guiding the person through days that are as safe, calm, and pleasant as possible
~Self-Care for the Caregiver"
15738985|NCT04951024|Procedure|Thoracolumbar interfacial plane (TLIP) Block|TLIP Block: Bilateral 20 ml 0.25 % Bupivacaine injected between multifidus and longissimus muscle with Ultrasound guidance.
15738986|NCT04951024|Procedure|Erector Spinae Plane (ESP) Block|ESP Block: Bilateral 20 ml 0.25 % Bupivacaine injected between the erector spinae muscles and transverse process with Ultrasound guidance.
15738987|NCT04951011|Diagnostic Test|Serum beta HCG|Raising numbers of S BHCG or decreasing with different management of tubal Ectopic Pregnancy
15738989|NCT04950985|Other|Observational Study|Observational study
15738991|NCT04950933|Drug|Huolingshengji Granules|1 bag of Huolingshengji Granules each time + 1 tablet of Riluzole tablet simulation agent each time, twice a day, orally;
15738992|NCT04950933|Drug|Riluzole tablet|Huolingshengji granules simulation agent 1 bag each time + Riluzole tablet 1 tablet each time, 2 times a day, orally.
15738993|NCT04950920|Drug|Y-2 sublingual tablets|OR， Qd
15738994|NCT04950907|Diagnostic Test|vats|Use uniportal tubeless VATS to obtain the biopsy
15738995|NCT04950907|Diagnostic Test|CT-guided fine needle biopsy|Use CT-guided fine needle to obtain the biopsy
15738996|NCT04950894|Device|Hypoglossal Nerve Stimulation|Hypoglossal Nerve Stimulation started at Month 1 compared to no Stimulation (Control group will start stimulation at M7+1Day)
15739090|NCT04950153|Behavioral|Testing Peer Navigation|Peer navigators will conduct HIV testing outreach and linkage to care to at-risk youth
15738997|NCT04950881|Procedure|Ultrasound guided vagus nerve block|Before the operation starts, patients received the ultrasound guided vagus nerve block. A 50mm Braun nerve stimulation needle is guided by the ultrasonic beam to insert into the carotid sheath and 10ml of lidocaine is injected.
15738998|NCT04950881|Drug|Bradycardia Treatment|If the OVR happens because the surgical stimulation, the operation suspends and atropine (0.01-0.02mg/kg) or isoproterenol (1-2 μg/per time)is given intravenously to increase the heart rate.
15738999|NCT04950868|Drug|Quetiapine|They will initially be given 25 mg of quetiapine per day. The dose may be increased by 25-50 mg per week, to a maximum dose of 150 mg per day by week 6 of the study.
15739000|NCT04950855|Diagnostic Test|Optical Coherence Tomography,Optical Coherence Tomography Angiography(Topcon)|Optical coherence tomography optical coherence tomography angiography
15739001|NCT04950842|Biological|JB-101|induced T cell with suppressive function
15739002|NCT04950829|Device|Conventional brackets|These brackets are used in a conventional way, where the orthodontist used to apply elastic parts to engage the arch to the slot of the brackets.
15739003|NCT04950829|Device|Self-ligating brackets|These brackets do not need to use elastic parts to engage the arch to the brackets. The orthodontist can use sliding caps to open and close the slots of these brackets.
15739004|NCT04950829|Procedure|Self-Ligating Brackets with flapless corticotomy|"These brackets do not need to use elastic parts to engage the arch to the brackets. The orthodontist can use sliding caps to open and close the slots of these brackets.
~Flapless corticotomy will be performed in order to stimulate acceleration in tooth movement during the orthodontic treatment in this group only."
15739005|NCT04950816|Behavioral|tailored MBI (.b)|The session will include brief didactic presentations, videos, and mindfulness practice followed by inquiry. We anticipate that sessions will take place twice a week. Sessions will be held on site at the Covenant House Texas (CHT) shelter in a quiet, designated learning space to ease access to sessions for the participants and to assure access to shelter staff (e.g., social workers and case managers) and services (e.g., food and shelter). CHT has onsite, weekday clinical and mental health care and established protocols for accessing needed resources 24/7. Selection criteria for the interventionist include maintaining a personal mindfulness practice for at least two years, trained in .b, and prior experience working with high-risk youth. The interventionist will receive additional training in Trauma-Informed Care as well as study procedures.
15739006|NCT04950816|Behavioral|attention control condition|Participants will receive no training in MBI or meditation. Topics covered may include physical activity, nutrition, managing weight, understanding adolescence, personal care, avoiding tobacco, alcohol, and drugs though this will be finalized in YR-1 with the HYWG and advisory panel. The HT program will be led by a positive adult instructor with training in health education or a related field and experience working with YEH.
15739007|NCT04950803|Dietary Supplement|Microbiome immunity formula|Microbiome immunity formula contains probiotics blend (3Bifidobacteria, 10 billion CFU per sachet)
15739008|NCT04950803|Dietary Supplement|Active placebo|Active placebo contains active vitamin
15739009|NCT04950790|Drug|Shuxinin injection|Shuxuening injection : 5ml/ injection, intravenous infusion, 20ml each time, once a day, diluted 250ml with normal saline, 15-30 drops/min.
15739010|NCT04950790|Drug|Basic treatment|Give oral aspirin enteric soluble tablets 150-300mg/d as early as possible after the onset of the disease, which can be changed to a prophylactic dose (50-325mg/d) after the acute phase. For those who cannot tolerate For those who cannot tolerate aspirin, clopidogrel can be used.
15739011|NCT04950790|Drug|Placebo|sterilized water for injection，5ml/ injection, intravenous infusion, 20ml each time, once a day, diluted 250ml with normal saline, 15-30 drops/min.
15739012|NCT04950777|Behavioral|patient education document|The patient education will be designed to address and investigate the four domains of physical literacy including, knowledge and understanding, motivation and confidence, daily behavior, and physical competence, (i.e., referral based training/PT (passive), self-motivated/directed exercise choice (speaks to child ownership/motivation), simple play outside 60 minutes/day (middle)).
15739015|NCT04950751|Biological|candidate vaccine, SCB-2020S|a recombinant SARS-Co-2 trimeric S-protein (from B.1.351 variant) subunit vaccine for COVID-19
15739016|NCT04950738|Other|pess tack acupuncture|Patients enrolled will receive intervention in a form of either press tack acupuncture needles or press tack placebos. Three total intervention sessions will be taken place on day 1,3,5 from patient's enrolment. Needles/placebos skin withdrawal will be done 48 hours after treatment by an acupuncture doctor or by a trained ICU nurne. In cases when a patient will be transferred from the ICU, the 3 study interventions will be continued in the new ward.
15739017|NCT04950738|Other|pess tack placebo|pess tack stickers without a needle
15739018|NCT04950725|Behavioral|Strength RMT|2 sets of 10 breaths twice per day using the breather or 3 sets of 10 breaths, twice per day using the Breather Fit
15739019|NCT04950725|Behavioral|Strength RMT and nasal breathing|2 sets of 10 breaths twice per day using the Breather or 3 sets of 10 breaths twice per day using the Breather Fit. Subjects will also be asked to complete 2 sets of 10 nasal breathing exercises either before or after the RMT exercise.
15739020|NCT04950725|Behavioral|Endurance RMT|15 breaths twice per day using the Breather or 20 breaths twice per day using the Breather Fit
15739021|NCT04950725|Behavioral|Endurance RMT and nasal breathing|15 breaths twice per day using the Breather or 20 breaths twice per day using the Breather Fit at a lower intensity for a longer duration without break. Subjects will also perform 2 sets of 10 nasal breathing exercises either before or after the RMT exercise.
15739022|NCT04950725|Behavioral|Low dose RMT|10 breaths, 3 times per week, at an intensity of 3 to 4 out of 10 using the Breather device.
15739025|NCT04950699|Genetic|Single-nucleotide Polymorphism of genes related with Dyslipidemia|This study is an observational study to study the effect of different genotypes on the incidence of myocardial infarction
15740817|NCT04935788|Dietary Supplement|milk/pea protein blend|milk/pea protein supplement
15739026|NCT04950686|Behavioral|Media Aware for Young Adults|Media Aware for Young Adults is a web-based sexual and relationship health promotion program designed for young adults that uses a media literacy education (MLE) approach.
15739027|NCT04950686|Behavioral|Health Aware for Young Adults|Media Aware for Young Adults is a web-based sexual and relationship health promotion program designed for young adults.
15739028|NCT04950673|Device|Cognivue|Computerized Cognitive Assessment Device
15739031|NCT04950647|Drug|Nitrofurazone Group 1|Test group 1: Nitroketazine tablet 600 mg group (Nitroketazine 300 mg tablet X2 + placebo 300 mg tablet ×2 tablets each time; If the subject progresses and cannot take 300mg tablets, Nitroketazine 100mg tablets x6 + placebo 100mg tablets x6) can be replaced.
15739032|NCT04950647|Drug|Nitroketazine Group 2|Test group 2: Nitroketazine tablets 1200 mg group (each oral Nitroketazine 300 mg tablets x4 tablets; If the subject progresses and cannot take 300 mg tablets, Nitroketazine 100mg tablets x12 tablets can be taken instead).
15739033|NCT04950647|Drug|placebo group|Control group: placebo group (placebo 300mg tablets x4 tablets each orally; If subjects progress and cannot take 300mg tablets, they may take placebo 100 mg tablets x 12 tablets instead).
15739034|NCT04950621|Drug|remimazolam|Remimazolam will be administered during induction and maintenance for general anesthesia.
15739035|NCT04950621|Drug|propofol|Propofol will be administered during induction and maintenance for general anesthesia.
15739036|NCT04950608|Drug|Psilocybin|Oral, single administration, dosage 25 mg orally
15739037|NCT04950608|Behavioral|Psychotherapy|The treatment regimen consists of a single administration of psilocybin orally combined with a supportive psychotherapy including 2 preparation sessions and 2 integration sessions
15739038|NCT04950595|Other|Plant-based mince|Spaghetti bolognaise meal made with plant-based mince
15739039|NCT04950595|Other|Beef mince|Spaghetti bolognaise meal made with beef mince
15739040|NCT04950582|Diagnostic Test|Spectral characteristics assessment|Urine sample analysis for evidence of urinary tract infection
15739041|NCT04950569|Drug|levosimendan|On the basis of standard conventional anti-heart failure treatment, levosimendan was used for 24 hours. The first load was 12 μg/kg, intravenous injection for 10 minutes, followed by intravenous infusion of 0.1 μg/Kg/min for 24 hours.
15739042|NCT04950556|Other|Exercise|Pelvic floor muscle exercise will be given to the exercise group
15739043|NCT04950556|Other|Control|No intervention
15739044|NCT04950543|Behavioral|Meditation|An online survey will be offered to participants who have enrolled in a 21-day meditation online course. The survey will be conducted using mobile website technology before and after the online course and additionally after 3 and 6 months.
15739045|NCT04950530|Drug|BIKTARVY 50Mg-200Mg-25Mg Tablet|A three-drug fixed dose combination tablet containing 50mg of bictegravir, 200mg of emtricitabine, and 25mg of tenofovir alafenamide taken once daily, orally
15739046|NCT04950504|Drug|CNP-201|CNP-201 is comprised of purified peanut extract (PPE) drug substance dispersed within a negatively charged polymer matrix of poly (lactic-co-glycolic acid) (PLGA) particles at a target concentration of ~5 μg of PPE per mg of PLGA.
15739047|NCT04950504|Drug|Placebo|CNP-201 Placebo
15739048|NCT04950491|Other|Modified Dental Anxiety Score (MDAS) questionnaire|MDAS was used to measure the patients' anxiety toward dental treatment before implant surgery (Humphris, Dyer, &Robinson, 2009). Originally, the MDAS questionnaire included five questions answered with a 5-category Likert scale. The original MDAS questionnaire does not cover anxiety toward implant surgery. Therefore, a question enquiring about patients' feelings towards implant surgery was added.
15739049|NCT04950491|Other|Pain questionnaire|Patients were asked to describe the worst pain feeling using a standard 10 cm Visual Analog Scale (VAS) and the proportion of time spent in severe pain using a 5 category Likert scale. The number of analgesics taken per day was also asked.
15739050|NCT04950491|Other|Oral Health-Related Quality of Life (OHRQoL) questionnaire|The OHRQoL comprises 14 questions covering problems the patient may in three main categories: oral function, daily activity, and post-operative symptoms (Chaushu, Becker, Zeltser, Vasker, & Chaushu, 2004). Patients answered using a 5-category Likert scale.
15739051|NCT04950478|Other|Virtual Reality|5 minutes before the procedure, they were recorded on 'Child and Parent Information Form', State-Trait Anxiety Inventory for Children and FPS-R. Their heart rate and oxygen saturation values were read and recorded. Children wore the virtual reality headset and game was started one minute before the venipuncture. As soon as the injector inserted, the researcher turned on a stopwatch and read and recorded heart rate and oxygen saturation values. When the injector was removed, the researcher stopped the stopwatch and recorded the duration of the procedure.When the injector was removed, the stopwatch was stopped and heart rate and oxygen saturation were recorded. The children took off the virtual reality headset and were asked to evaluate their pain level through FPS-R and their responses were recorded.
15739052|NCT04950465|Other|Sensodyne Sensitivity & Gum|Sensodyne Sensitivity & Gum toothpaste containing 0.454% SnF2.
15739053|NCT04950465|Other|Crest Cavity Protection Fresh Lime|Crest Cavity Protection Fresh Lime is containing 1150 parts per million fluoride as Sodium fluoride.
15739054|NCT04950465|Other|Sensodyne Repair and Protect|Sensodyne Repair and Protect dentifrice containing 5.0% weight/weight calcium sodium phosphosilicate.
15739055|NCT04950452|Behavioral|Exercise Training|Supervised exercise training
15739056|NCT04950439|Other|Collect blood sample|A blood sample dedicated to the study and necessary for routine care is taken. The pulse wave velocity and systolic pressure index are measured. A myocardial CT scan coupled with a computed tomography is performed. The patient collects stools at his home, simply conditions them and sends them by mail to the centre, which stores them.
15739057|NCT04950426|Drug|Propranolol|One administration of propranolol, once a week during six weeks. Reading by the participant of his/her traumatic story, 75 minutes (+/- 15 min) after propranolol intake.
15739058|NCT04950413|Other|Conventional physical therapy program|Infrared, Exercises, Stretching exercise of Suboccepital muscle
15740871|NCT04935320|Drug|HTL0016878.HCl Solution 10 mg|Oral solution fasted
15739059|NCT04950413|Other|IASTM by M2t blade|A lubricant (Vaseline) will be applied to the skin around the neck area prior to treatment and the M2t blade will be cleaned with an alcohol pad. First, the M2T blade will used to ﬁnd the exact areas of restriction in affected muscles. Then the M2T blade will use at an angle of 45 to apply slow strokes along the muscle. Changes in soft tissue consistency will detected by the clinician through vibrations of the instrument when it slides on areas of irregular fibrosis of the underneath connective tissue. Once an adhesion is discovered, strokes are repeated for 5 min.
15739060|NCT04950413|Device|Phonophoresis|It will be consisted of 1 MHz pulsed mode with an intensity set at 1.5 W/cm2 and. A 5 cm2 crystal head with an effective radiating area of 4.0 cm2 ±1.0 wills utilized for 5 Min for each trigger point of neck. lidocine gelwill applied instead of coupling US gel used for transmission.
15739061|NCT04950400|Drug|Carrelizumab + chemotherapy + apatinib|Subjects will receive 200 mg of karizumab every three weeks，Pemetrexed 500 mg / m2 was given on the first day of each cycle,Every three weeks was a period of administration,Carboplatin AUC 5 was given on the first day of each cycle and every three weeks was a cycle，Paclitaxel 175 mg / m2 was given on the first day of each cycle, and every three weeks was an administration cycle，with intravenous drip，Apatinib, 250 mg, oral, once a day (PO, QD), every 3 weeks as a cycle.
15739062|NCT04950387|Other|Breathing exercises|Based in yoga, common load
15739063|NCT04950374|Other|Moisturizer Body Lotion|The body lotion product is a moisturizing formulation intended for topical use on the whole body and face. It will be applied at least twice daily.
15739064|NCT04950374|Other|Lip Moisturizer|The lip product is a moisturizing formulation intended for topical use on the lips. It will be applied at least twice daily.
15739065|NCT04950361|Other|talocalcaneal coalition|patients with talocalcaneal coalition
15739066|NCT04950348|Device|Personalized TKA prosthesis|TKA prosthesis that is designed and manufactured according to the patient's knee joint anatomy
15739067|NCT04950348|Device|Zimmer NexGen prostheses|Commercial products used on a large scale
15739068|NCT04950335|Procedure|AOPT|The Osteochondral Autograft Transplant System (Arthrex) was used to create donor plugs. Osteoperiosteal grafts were harvested from the ipsilateral anterior superior iliac spine.
15739069|NCT04950335|Procedure|AOCT|Osteochondral grafts were harvested from the non-weight-bearing zone of the ipsilateral anterolateral distal femur.
15739070|NCT04950322|Drug|SHR-1701、CAPOX/FOLFOX|"SHR-1701 with CAPOX/FOLFOX (CAPOX:Oxaliplatin,Capecitabine;FOLFOX:Oxaliplatin,Leucovorin,Fluorouracil
~)"
15739071|NCT04950322|Drug|Placebo、CAPOX/FOLFOX|"Placebo with CAPOX/FOLFOX (CAPOX:Oxaliplatin,Capecitabine;FOLFOX:Oxaliplatin,Leucovorin,Fluorouracil
~)"
15739074|NCT04950296|Other|Group I: L. plantarum UALp-05TM,|One capsule to be taken orally before lunch with a glass of water. In case the dose is missed, advise participant to take before dinner.
15739075|NCT04950296|Other|Group II: L. plantarum UALp-05TM,|One capsule to be taken orally before lunch with a glass of water. In case the dose is missed, advise participant to take before dinner.
15739076|NCT04950296|Other|Microcrystalline cellulose|One capsule to be taken orally before lunch with a glass of water. In case the dose is missed, advise participant to take before dinner.
15739077|NCT04950283|Diagnostic Test|magnetic resonance examination, anthropometric and metabolic characterization|Participants undergo a magnetic resonance examination, anthropometric characterization and metabolic characterization via oral glucose tolerance test.
15739078|NCT04950270|Biological|Blood copeptin monitoring|Blood copeptin monitoring during the first 6 days of ICU stay with PRES
15739079|NCT04950270|Other|phone interview|Structured phone interview at 3 months to collect vital status and modified Rankin Scale score
15739080|NCT04950257|Device|digital CBT self-help including specific intervention elements to target worry and rumination.|The self-help app includes self-monitoring, psychoeducation and active self-help exercises. The self-monitoring includes daily mood ratings and an ecological momentary assessment option (MoodTracker) for more detailed analysis of mood, worry, activity and situational context. The digital self-help provides psychoeducation, tips, advice, exercises and training for each individual focused on reducing worry and rumination, using strategies from the proven rumination-focused CBT intervention. The app includes text, pictures, audio-recordings, animations, audio-exercises to practice (e.g., self-compassion, relaxation, concreteness exercises), and questionnaires with tailored feedback. The app is designed for iOS and Android use.
15739082|NCT04950231|Other|The questionnaire survey|Questionnaires were issued and collected by 6 competent nurses with strict training, data entry by 2 researchers, statistical analysis by 1 researcher, and quality control by the other 2 researchers throughout the process.
15739083|NCT04950205|Drug|Sevoflurane inhalant product|propofol plus 1% sevoflurane after open Carotid artery until the end of surgery
15739084|NCT04950192|Device|ICE Image guidance|ICE image guidance will be used on all patients undergoing planned cardiac catheterization procedures
15739085|NCT04950179|Other|PDRI patients|The study was conducted by retrospective data collection from medical records of 135 continuous ambulatory peritoneal dialysis (CAPD) patients at Phramongkutklao Hospital from January 1, 2016 to December 31, 2020.
15739087|NCT04950153|Behavioral|Peer navigation|Peer navigators will navigate youth with HIV to provide assistance and support to optimize adherence to antiretroviral treatment (ART)
15739088|NCT04950153|Behavioral|SMS Text messaging|Short Message System (SMS) text messages to remind and encourage youth to adhere to their ART
15739089|NCT04950153|Behavioral|Social Media Engagement|HIV testing outreach using social media platforms to promote HIV testing.
15739091|NCT04950140|Procedure|Robot Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia|Robot Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient
15739092|NCT04950140|Procedure|Laparoscopic Surgery for the Treatment of Parastomal Hernia|Laparoscopic Surgery for the Treatment of Parastomal Hernia in Cancer Patients
15739093|NCT04950127|Drug|Linerixibat|Participants will receive linerixibat.
15739094|NCT04950127|Drug|Placebo|Participants will receive placebo.
15739095|NCT04950114|Drug|GFB-887|GFB-887 is a potent, small molecule inhibitor of TRPC5.
15739096|NCT04950101|Other|anal sampling|anal sampling will be performed both in men without HIV and men having HIV in order to see if they have HPV or not
15739097|NCT04950088|Other|Hand-held video game device|
15739100|NCT04950062|Other|High Intensity Interval Training|"Warming up period for 5 min at an intensity corresponding to 65-75% of heart rate maximum (HRmax).
~Training phase for 30 min divided into four sets of 4-min length each at intensity equals 80-90% of HRmax interspersed by 3 minutes low intensity walking at the level of 65-75% of HRmax.
~Cooling down period for 5 min of at 50-60% of the HRmax. All subjects will be trained at the lower intensity limit for the first 2 weeks of the program before increasing the intensity levels toward the upper limit."
15739101|NCT04950062|Other|Intermittent Fasting 16/8 Protocol|Every subject will be instructed to fast a fixed 16 hours followed by 8 hours of eating every day through the whole study period based on their life and sleeping style. During fasting, zero-calorie coffee, tea and water intake will be permitted. Beverages containing calories were consumed during the feeding hours each day. All subjects will be instructed about their optimum caloric requirement based on their basal metabolic rate that will be calculated in advance to avoid over consumption of food on severe caloric restriction as we like to investigate the effect of this way of fasting on reducing weight and improving functional capacity.
15739102|NCT04950049|Drug|Dexamethasone|receive 2ml dexamethasone (5mg/ml)
15739103|NCT04950049|Other|Diluted dexamethasone 5ml|receive 5ml dexamethasone (2mg/ml) diluted with 5% glucose
15739104|NCT04950049|Other|Diluted dexamethasone 10ml|receive 10ml dexamethasone (1mg/ml) diluted with 5% glucose
15739105|NCT04950049|Other|Diluted dexamethasone 20ml|receive 20ml dexamethasone (0.5mg/ml) diluted with 5% glucose
15739106|NCT04950036|Diagnostic Test|Diagnostic Test|The results of hip arthroscopy were taken as the gold standard and MRI examination was taken as the research object.
15739107|NCT04950010|Behavioral|High-Intensity Interval Training|HIIT is a type of training in which short periods of high-intensity anaerobic exercise (1-4 minutes at 80-95% of VO2peak) are alternated with less intense aerobic recovery periods (1-3 minutes at 50-60% VO2peak). Individually-tailored exercise prescriptions will be developed based upon each participant's baseline maximal graded exercise test (heart rate corresponding with %VO2 peak) and symptom limitation. Sessions will be progressive in nature such that the volume of exercise (i.e., number and intensity of intervals) increases across weeks. Intervals will progress from a heart rate corresponding with 75% VO2peak in Week 1 to 90-95% VO2peak in Weeks 9-12. Sessions will be ~30 minutes in length. Indoor cycling is the primary mode of exercise.
15739108|NCT04950010|Behavioral|Moderate-Intensity Exercise|Individually-tailored exercise prescriptions will be developed based upon each participant's baseline maximal graded exercise test (heart rate corresponding with %VO2 peak) and symptom limitation. Sessions will be progressive in nature such that the volume of exercise increases across weeks. Indoor cycling is the primary mode of exercise. Sessions will include moderate-intensity cycling that progresses from a heart rate corresponding with 55-60% VO2peak for 30 minutes in Week 1 to 65-70% VO2peak for 45-50 minutes in Weeks 9-12.
15739109|NCT04949997|Other|diagnose|HF was divided into HF with preserved ejection fraction, HF with median ejection fraction and HF with reduced ejection fraction.
15739110|NCT04949984|Device|Bright light therapy|BLT consisted of 30-minute morning sessions with an intensity of 10,000 lux, five days a week (Monday to Friday), for 4 weeks.
15739111|NCT04949971|Behavioral|High volume group|Thea High tidal volume of the exposed group was 10ml/kg ideal body weight
15739112|NCT04949958|Other|Exercise Based Manual (Supervised)|Exercise Based Manual for Pre Diabetic subjects will consist of two components; Exercise, Exercise and Education. The exercise will be supervised while other component will be home based.
15739113|NCT04949958|Other|Exercise Based Manual (Home Based)|Exercise Based Manual for Pre Diabetic subjects will consist of two components; Exercise and Education. All two components will be home based.
15739114|NCT04949958|Other|Control|General advice to be active
15739115|NCT04949945|Behavioral|Self Help Culturally Cognitive Behavioral Therapy|Experimental group (CHF patients)will be screened on PHQ9 questionnaire for depression after receiving guided self help culturally adapted cognitive therapy they will be reassessed for their depression,improvement in functional disability ,improvement in classification of NYHA,reduction in hospital admission as compare to control group.
15739116|NCT04949932|Other|Mixed powder of Lens culinaris, Curcuma longa, Mentha arvensis, Azadirachta indica, and Trigonella foenumgraecum.|Study subjects were prescribed either PHP or placebo once daily at night for 3 weeks consecutively. A dose of 1-2 tea spoonfuls powder had to mixed with water to make paste. Then it was applied on face (except around the eyes) and had to wait for 20-30 minutes until it dries.Then they were washed face by using normal water.
15739117|NCT04949932|Other|Cicer arietinum powder|Study subjects were prescribed either PHP or placebo once daily at night for 3 weeks consecutively. A dose of 1-2 tea spoonfuls powder had to mixed with water to make paste. Then it was applied on face (except around the eyes) and had to wait for 20-30 minutes until it dries.Then they were washed face by using normal water.
15739118|NCT04949919|Other|aerobic training by a cycle ergometer and Biodex system 4 pro|cyclic aerobic training in moderate-intensity and high-intensity interval training plus isokinetic resistance training prior to HD. 60 training sessions in 6 months.
15739119|NCT04949906|Drug|Raise serum brain granules|Should Yangseronao granules be used in patients undergoing intravenous thrombolysis for the diagnosis of acute ischemic stroke
15739120|NCT04949906|Drug|No nourishing serum brain granules are used|No nourishing serum brain granules are used
15739121|NCT04949880|Device|Drug-Eluting Balloon Dilatation Catheter|The catheter consists of a tip, a drug-coated balloon, a mark, a catheter and a catheter hub. The main component of the drug coating was sirolimus, and the coating was evenly distributed on the effective length surface of the balloon.
15739123|NCT04949867|Device|Closed-loop System|Closed-loop system comprise of two DANA RS (R) insulin pumps (FiAsp-GlucaGen vs FiAsp-saline), one DexCom G6 sensor, and a smartphone for the control algorithm.
15739127|NCT04949828|Drug|CREON|Oral Capsules
15739128|NCT04949802|Device|Vialase laser|create an aperture through the trabecular meshwork
15739134|NCT04949776|Diagnostic Test|Mammograms|"In the women participating in the study, two strategies for reading mammograms will be carried out:
~Strategy 1: Standard reading of the program. Double independent and non-consensual reading of all cases, without any artificial intelligence system (standard strategy).
~Strategy 2: Reading strategy based on the global Score granted by Transpara® (strategy based on artificial intelligence):
~In studies with a Score <8 (studies with a low probability of cancer): They will not be evaluated by any radiologist.
~In studies with a Score> 7 (studies with a high probability of cancer): double reading will be carried out, assisted by Transpara®."
15739135|NCT04949763|Other|rehabilitation|Patients underwent ususal rehabilitation treatment
15739136|NCT04949750|Other|Paper - based cognitive training|Cognitive training
15739137|NCT04949737|Biological|Helicobacter Pylori detection|"Biopsies will be sent to the referral anatomopathology laboratory. The search for Helicobacter pylori will be performed by immunohistochemistry. An additional blood sample for serological testing will be taken during the initial workup.
~Additional data will be collected through a questionnaire."
15739138|NCT04949724|Other|translation and adaptation study|translation and adaptation study
15739141|NCT04949698|Device|plasma exchange|Plasma exchange was performed daily for five times or until platelet level returned to normal
15739142|NCT04949685|Procedure|plantar plate repair|surgical repair via dorsal approach of lesser metatarsophalangeal joint general anesthesia
15739143|NCT04949659|Procedure|Laparoscopic appendectomy|Laparoscopic appendectomy performed with defined, randomized to level of pressure for pneumoperitoneum
15739144|NCT04949646|Other|Pelvic Intraoperative Neuromonitoring|Pelvic Intraoperative Neuromonitoring (pIONM) allows mapping of the pelvic autonomous plexus during total mesorectal excision (TME).
15739147|NCT04949620|Behavioral|REThink therapeutic game|REThink is a online therapeutic game developed by David and collaborators (2018), proved to be an efficient intervention for the reduction of emotional symptoms in children and adolescents.
15739148|NCT04949620|Behavioral|Online parenting program|The online parenting intervention consists of a newly developed parenting program, including rational emotive behavioral therapy and schema therapy principles
15739149|NCT04949607|Dietary Supplement|Inulin fructooligosaccharide|Subjects will be administered inulin at a starting dose of 1g twice daily (2g/day) and ramping up an additional 2g/day until the final dose of 4g twice daily (8g/day), which will continue on until the end of month 3 (week 12). After the month 3 study visit, inulin dosing will begin to ramp down over the next week.
15739151|NCT04949581|Other|bioelectric therapy|the patient will receive microcurrent therapy from a supine lying position. the negative electrode on the incision area and the positive electrode proximal. the intensity will be less than 20 microamperes and frequency at 20 HZ.
15739152|NCT04949581|Other|cardiac rehabilitation program|the patient will receive cardiac rehabilitation program
15739153|NCT04949568|Behavioral|Objective. data|Objective data: Continuous glucose monitoring and physical activity.
15739154|NCT04949568|Device|Physical activity|actigraphy.
15739155|NCT04949555|Other|Primary congenital glaucoma evaluation|long term evaluation of primary congenital glaucoma management
15739156|NCT04949542|Behavioral|Bolster|Bolster is a native mobile app that provides on-demand content to caregivers of young adults with early psychosis to support their caregiving skills and knowledge of psychosis.
15739157|NCT04949542|Behavioral|Control|Exemplar resources provided in the control arm will include a selection from the National Alliance on Mental Illness and Mental Health America designed to support caregivers helping loved ones access care.
15739158|NCT04949516|Drug|Aspirin|Aspirin is discontinued the day after drug-eluting stent implantation
15739159|NCT04949516|Drug|Colchicine|Colchicine is started the day after drug-eluting stent implantation
15739160|NCT04949503|Drug|nimotuzumab|Patients in the study group were received nimotuzumab on the basis of chemoradiotherapy (control group).
15739161|NCT04949490|Biological|BNT162b2s01|intramuscular (IM) injection
15739162|NCT04949490|Biological|BNT162b2|IM injection
15739163|NCT04949477|Drug|Dexmedetomidine|the patient will receive intranasal dexmedetomidine at a dose of 1 μg/kg to the patient 45 min. before the procedure.
15739164|NCT04949477|Drug|paracetamol|the patient will receive paracetamol orally [Rx paracetamol 250 mg/ml] at a dose of 20 mg/kg given to the patient 45 min before the procedure by drinking.
15739165|NCT04949464|Procedure|Computed Tomography|Undergo LDCT
15739166|NCT04949464|Drug|Nicotine Replacement|Given nicotine replacement therapy
15739172|NCT04949438|Drug|AZD4831|Participants will receive a single dose of AZD4831 administered with 240 mL of water after an overnight fast of at least 10 hours.
15739173|NCT04949425|Drug|Adavosertib|Patients will receive Adavosertib orally.
15739174|NCT04949412|Diagnostic Test|Vitamin D|serum vitamin D level
15739177|NCT04949386|Drug|S-1226 (8%)|S-1226 has two components delivered by inhalation. It is a mixture of perfluorooctylbromide (PFOB) delivered in gas/aerosol/vapor form within a medical gas mixture containing 8% CO2.
15739178|NCT04949386|Other|Placebo|Placebo will delivered by inhalation of saline (0.9% NaCl) and Medical grade air.
15739179|NCT04949373|Device|High-intensity laser therapy (HILT)|"High intensity laser therapy-Patients will receive pulsed laser treatment, using a HIRO 3 device (ASA Laser, Arcugnano, Italy), five times a week for a period of three weeks, and one session per day for a total of 15 sessions. A 3-phase treatment program will be performed on each session.
~Other: Tendon and nerve gliding exercises will be performed three times a day with 10 repetitions each time for 3 weeks. Exercises will be performed by a trained physiotherapist.
~Other: Rest splint(at night) Participants will be splinted in neutral position with standard cotton-polyester splints.The patients will be encouraged to use the splints during nighttime for 12 weeks."
15739180|NCT04949373|Device|Sham High-intensity laser therapy (sham HILT)|"Sham high intensity laser therapy-Participants will receive pulsed laser treatment, using a HIRO 3 device (ASA Laser, Arcugnano, Italy), five times a week for a period of three weeks, and one session per day for a total of 15 sessions.
~Other: Tendon and nerve gliding exercises will be performed three times a day with 10 repetitions each time for 3 weeks. Exercises will be performed by a trained physiotherapist.
~Other: Rest splint(at night) Participants will be splinted in neutral position with standard cotton-polyester splints.The patients will be encouraged to use the splints during nighttime for 12 weeks."
15739181|NCT04949360|Behavioral|Online Cognitive-Behavioral Therapy for Insomnia and complementary therapies|The CBTi-O and CBTi-O+ interventions are based on real life user experience. The users will have access to different versions of the platform. The intervention will last eitght weeks.
15739182|NCT04949360|Behavioral|Regular Cognitive Behavioural Therapy for Insomnia|This is the gold standard behavioral treatment for insomnia and will be performed by independent board-certified sleep psychologists. The treatments will last eight weeks and the appointments will be made by video-calls.
15739183|NCT04949360|Behavioral|Sleep hygiene - minimal intervention|It is composed by educational material about normal sleep pattern and sleep hygiene. It will be delivered by regular mail and email.
15739184|NCT04949347|Biological|glaucoma drainage device implantation|Glaucoma drainage device implantation, a 350 mm2 Baerveldt (BG 101-350) GDD (Johnson and Johnson, Santa Ana, CA, USA) was performed using glycerin-preserved, human-donor, corneoscleral tissue ( the remaining from a heterologous, human-donor corneal button, obtained from the International Eye Bank of Thailand, after a clear corneal graft had been used for penetrating keratoplasty.) The tissue had been preserved in glycerin using the sterile technique and kept in a medical refrigerator for no longer than 6 months.
15739185|NCT04949334|Device|Dofin Breathing Strength Builder|"If the patient's condition is stable, respiratory muscle training will be performed under Dofin Breathing Strength Builder 7 days after stroke. The patient will receive respiratory muscle training by repetition of 30 times, two courses per day, x 7 days, for three weeks.
~The initial load was set at 30% of the participants' maximal baseline strength and increased weekly at intervals of 2 cmH2O."
15739186|NCT04949321|Other|Magnetic Resonance Imaging with Single dose of gadobutrol (Gd-DO3A-butrol, Gadovist® 0.1 mmol/kg, 1 mmol/mL)|Magnetic Resonance Imaging with Single dose of gadobutrol (Gd-DO3A-butrol, Gadovist® 0.1 mmol/kg, 1 mmol/mL)
15739187|NCT04949295|Device|ocular surface analyzer|Using ocular surface analyzer for Inspection
15739188|NCT04949282|Drug|Lutetium [177Lu] oxodotreotide/dotatate|Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)
15739189|NCT04949282|Device|Lutetium [177Lu] oxodotreotide/dotatate|Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)
15739190|NCT04949269|Drug|Deucravacitinib|Specified dose on specified days
15739191|NCT04949269|Drug|Famotidine|Specified dose on specified days
15739199|NCT04949243|Behavioral|Behavioral questionaires|Behavioral surveys and questionaires
15739200|NCT04949230|Other|No Intervention Used|There is no intervention in this study
15739201|NCT04949217|Procedure|Inlay Bristow|A modified Bristow procedure
15739202|NCT04949217|Procedure|Bristow|Traditional Bristow procedure
15739203|NCT04949204|Procedure|Wearable sensor detection|Empatica E4 wearable wrist sensor
15739204|NCT04949191|Drug|Pemigatinib|Pemigatinib tablets taken by mouth once daily as per protocol
15739205|NCT04949191|Drug|Retifanlimab|Retifanlimab is administered over 60 minutes once every 4 weeks (Day 1 of a 28-day cycle)
15739206|NCT04949191|Drug|Pembrolizumab|Commercially labeled products
15739207|NCT04949178|Other|No intervention|This is an observational study.
15739208|NCT04949165|Dietary Supplement|Iron Supplementation|low dose ferrous sulphate (65mg elemental iron) supplements
15739209|NCT04949139|Drug|Dextrose 5% in water|Reducing the sodium concentration
15739210|NCT04949126|Behavioral|questionnaire|questionnaires of precarity, dental anxiety, self medication, pain
15739211|NCT04949113|Drug|Neoadjuvant ipilimumab + nivolumab|2 cycles ipilimumab (80mg) + nivolumab (240mg) every 3 weeks followed by total lymph node dissection
15739213|NCT04949100|Device|Microcurrent Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief|"Duration: 60 minutes.
~Electrode placement: There will be one lead placed on the back of the neck and one placed on lower abdomen.
~Frequency: Each lead delivers a dual channel microcurrent of 10 and 40 Hz simultaneously.
~Amperage: Adjusted according to BMI: 100 μA for an underweight BMI less 20, 300μA for an overweight BMI greater than 30, and 200μA for normal BMI (20-30). Amperage may be adjusted to 20-300 μA according to comfort.
~Positioning: The patient remains seated for the first 10 minutes with the investigator watching for any side effects. The patient may stand, sit, lie supine, et cetera for the remainder of treatment."
15739214|NCT04949100|Device|PLACEBO Microcurrent Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief|"Duration: 60 minutes.
~Frequency: None
~Electrode placement: There will be one lead placed on the back of the neck and one placed on lower abdomen.
~Amperage: None
~Positioning: The patient remains seated for the first 10 minutes, again, with the investigator watching for any side effects. The patient may stand, sit, lie supine, et cetera for the remainder of treatment."
15739215|NCT04949087|Procedure|Glenohumeral Injection|Patients who enroll will be randomized into an injection group, and then will undergo the specified injection at one time point only.
15739216|NCT04949074|Other|saliva sampling|when the patient goes to the laboratory for a covid 19 diagnostic from a routine nasopharingeal sample, an additionnal sample of saliva is asked
15739217|NCT04949061|Behavioral|Culturally Adapted Cognitive Behavioral Intervention (CA-CBI)|CA-CBI is an intervention based on Culturally Adapted Cognitive Behavioral Therapy (CA-CBT) which was developed by Devon Hinton. This trans-diagnostic intervention has a structured manual which can be culturally adapted and it will be used to decrease psychological distress and increase quality of life by targeting cognitive and behavioral changes.
15739218|NCT04949061|Other|Enhanced Treatment as Usual (ETA-U)|Participants who receive ETAU will be provided a brief psychoeducation via online leaflets and will be informed about centers where they can receive free psychosocial support.
15739219|NCT04949048|Device|Magneto PE Kit|All enrolled patients will be treated with Magneto PE Kit
15739220|NCT04949035|Diagnostic Test|Assessment of mental state and quality of life|Patients qualified for rehabilitation will be assessed for stress levels as well as symptoms of anxiety and depression and quality of life before rehabilitation began
15739221|NCT04949022|Device|Medronic 780G insulin pump|Commercial hybrid closed loop system Medronic 780G
15739222|NCT04949009|Drug|Avatrombopag|Avatrombopag is an orally bioavailable, small molecule thrombopoietin receptor agonist that has been developed by Dova Pharmaceuticals for the treatment of thrombocytopenic disorders.
15739223|NCT04948996|Behavioral|El Buen Consejo Móvil- Group (EBCM-G)|"Psycho-education and Information using a CBT toolbox approach.
~Self-Assessment to track, label and describe moods by daily prompts to state or text level of mood on the mood tracker (termómetro de animo).
~Symptom Identification and Management: after identifying a label for type of thinking from a pull-down list, a corresponding short 1-3-minute recorded strategy such as Thought Stopping, Increasing Pleasurable Activity, Mindfulness or Priming will be provided.
~Monitoring of treatment engagement and response to treatment: Reminders to engage will include text messages and phone calls from the facilitator to encourage use of the app according to a scripted protocol.
~Additionally, participants in the Group Intervention will be able to communicate with and respond to one another through the group chat rooms within the app."
15739224|NCT04948996|Behavioral|El Buen Consejo Móvil- Individual (EBCM-I)|"Psycho-education and Information using a CBT toolbox approach.
~Self-Assessment to track, label and describe moods by daily prompts to state or text level of mood on the mood tracker (termómetro de animo).
~Symptom Identification and Management: after identifying a label for type of thinking from a pull-down list, a corresponding short 1-3-minute recorded strategy such as Thought Stopping, Increasing Pleasurable Activity, Mindfulness or Priming will be provided.
~Monitoring of treatment engagement and response to treatment: Reminders to engage will include text messages and phone calls from the facilitator to encourage use of the app according to a scripted protocol."
15739225|NCT04948983|Other|Decision aid (DA) for breast cancer screening|The online DA for breast cancer screening is a web-based education material to inform women about the benefits and risks associated with the screening. The contents of the DA are: 1) Assessing breast cancer; 2) What is breast cancer screening?; 3) What will happen if I diagnosed with breast cancer?; 4) What is overdiagnosis?; 5) What is false positive?; 6) the statistics of breast cancer screening; 7) Now is my turn, do I want to take it?
15739226|NCT04948983|Other|Standarised information for breast cancer screening|Information provided by the Chilean Ministry of Health in regards to access to breast cancer screening (Age, frequency and costs)
15739227|NCT04948957|Drug|Esmolol|
15739228|NCT04948957|Drug|Nitroglycerin|
15739229|NCT04948944|Device|transcranial direct current stimulation|the tDCS stimulator delivers very low (2mAmp) current with surface electrodes to the skull
15739230|NCT04948931|Other|Lavender aromatherapy|The application will be once a day, every day for four weeks. Each session will take five minutes.
15739231|NCT04948931|Other|Rosemary aromatherapy|The application will be once a day, every day for four weeks. Each session will take five minutes.
15739232|NCT04948931|Other|Control|The application will be once a day, every day for four weeks. Each session will take five minutes.
15739233|NCT04948918|Procedure|Anatomically optimized distal renal denervation|Bilateral radiofrequency renal denervation will be performed using Symplicity Spyral renal denervation system. Generally, at least two separate applications of radiofrequency energy will be performed in each segmental branch of renal artery. Each application will be done through 4 electrodes deployed in helical manner according to the design of the catheter
15739264|NCT04948619|Biological|Vaccine|Patients will have lab evaluations for immune function at baseline, 3, 6, 12, and 24 months post completion of treatment. At 3 months off therapy, patients with abnormal vaccine antibody titers will be randomized to receive either single booster vaccines or to begin a full revaccination series that models post-hematopoietic stem cell transplant vaccination strategies.
15739265|NCT04948606|Drug|Diroximel Fumarate|Administered as specified in the treatment arm.
15739266|NCT04948593|Procedure|Native kidney biopsy|
15739267|NCT04948580|Behavioral|Interaction Competencies with Children - for Teachers (ICC-T)|Core training components include teacher-student interaction, maltreatment prevention, effective discipline strategies, identifying and supporting burdened students and implementation of the training materials into the school setting
15739234|NCT04948905|Other|Evaluation using the Self-Defining Memory Questionnaire|"This questionnaire consists of 3 pages. Page 1 gives a clear, concise definition of a memory that defines the self. This enlightens the subject on what is expected and helps him/her consider the phenomenological characteristics of the Self-Defining Memory. Page 2 recalls the 6 essential characteristics of the Self-Defining Memory. Page 3 allows the practical application of what has been understood about the questionnaire. At least 3 memories are asked of the participants. Each memory is rated as follows : On a scale of 0 - 6 for each of the following emotions, participants note how they feel when recalling each memory. Happy, Sad, Angry, Fearful, Surprised, Ashamed,Disgusted,Guilty, Interested, Embarrassed, Contemptful, Proud. 0 = not at all, 3 = Moderately and 6 = Extremely.
~Participants must then use the same scale to indicate the vividness and importance of the memory.
~They must also note the approximate number of years ago the memory took place (to the nearest whole number)."
15739236|NCT04948879|Procedure|Vascular resection/reconstruction|The resection of a major blood vessel with or without reconstruction
15739237|NCT04948866|Behavioral|ADRD-PC Program|Included in arm/group descriptions
15739238|NCT04948853|Behavioral|Individual Placement Support - Supported Employment|Individual, person-centered intervention designed to help individuals living with mental illnesses obtain and sustain meaningful employment. This is an evidence-based practice for individuals with severe mental illnesses.
15739239|NCT04948840|Biological|Blood sampling|Blood sample of 7 mL whole venous blood in an EDTA citrate tube (4.5 mL) and a PAXgene Blood RNA tube (2.5 mL).
15739240|NCT04948827|Drug|SBP-9330|SBP-9330 oral capsules
15739241|NCT04948827|Drug|Placebo|Placebo oral capsules
15739242|NCT04948814|Biological|Fecal microbiota transplantation|FMT utilizing stool from healthy children
15739243|NCT04948814|Drug|Vancomycin|40mg/kg/day
15739244|NCT04948801|Drug|Epclusa (sofosbuvir and velpatasvir)|Epclusa (sofosbuvir and velpatasvir) is a nucleotide analog polymerase inhibitor and pan-genotypic NS5A inhibitor fixed-dose combination for the treatment of chronic genotype 1-6 hepatitis C virus (HCV) infection.
15739245|NCT04948788|Drug|SHR1459 ；YY-20394|SHR1459 plus YY-20394
15739246|NCT04948788|Drug|SHR1459 ；YY-20394|SHR1459 plus YY-20394
15739247|NCT04948788|Drug|Gemcitabine-Oxaliplatin|Gemcitabine-Oxaliplatin
15739248|NCT04948775|Other|Cervical stabilization exercises|Cervical stabilization exercises are aimed to train deep stabilizer muscles of the cervical spine and improve coordination between superficial and deep cervical muscles. These exercises have been increasingly used in recent years. These exercises require patients to control neutral spinal alignment with stabilizer muscle activations in various conditions, beginning with gentle craniocervical nods and proceeding through increased levels of extremity loading.
15739249|NCT04948749|Procedure|Drug Eluting Stent implantation|The Maurora ® Sirolimus Eluting Stent System for intracranial PTA treatment comprises of a balloon expandable sirolimus eluting stent and a delivery catheter that features a rapid exchange catheter design with a semi-compliant balloon located at its distal end.
15739250|NCT04948749|Drug|Aggressive medical treatment|Aggressive medical treatment consists of dual antiplatelet treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 per day mg, or ticagrelor 90 mg twice per day for 6 months after enrollment).
15739251|NCT04948749|Behavioral|Risk factor management|Intensive management of the primary risk (systolic blood pressure and low density lipoprotein [LDL]), and management of secondary risk factors (diabetes, non-high-density lipo- protein [non-HDL], smoking, weight, and exercise).
15739252|NCT04948749|Drug|Standard medical treatment|Standard medical treatment consists of dual antiplatelet treatment (aspirin 100 mg per day for the entire follow-up, clopidogrel 75 per day mg, or ticagrelor 90 mg twice per day for 3 months after enrollment).
15739255|NCT04948710|Diagnostic Test|Sonography|Sonographic Venous Doppler Imaging
15739256|NCT04948697|Drug|Ociperlimab|900 mg intravenously once every 3 weeks (dosed in 21-day cycles)
15739257|NCT04948697|Drug|Tislelizumab|200 mg intravenously once every 3 weeks (dosed in 21-day cycles)
15739258|NCT04948697|Drug|BAT1706|15 mg/kg intravenously once every 3 weeks (dosed in 21-day cycles)
15739259|NCT04948671|Other|there will be no intervention, this is an observational study|this is an observational study
15739262|NCT04948632|Other|Complete LeoMed application|Installation of the complete LeoMed application on the participant's smartphone during a visit at the preoperative clinic. The day before surgery, participants will receive notifications encouraging them to use the platform to help prepare for their surgery. Safety instructions will also be sent. Postoperatively, notifications will be sent to the participants every day during the first 4 days and on the 14th day. These notifications will direct them to online forms that aim to assess their condition. On the 30th postoperative day, the platform will send a final follow-up form. The platform will collect this information and classify it for appropriate management of their condition.
15739263|NCT04948632|Other|Basic LeoMed application|Installation of a partial version of the LeoMed application on the patient's smartphone during a visit to the preoperative clinic. Before surgery, participants will receive a phone call to be summoned to the hospital and to remind them of the safety instructions. Postoperatively, their follow-up will not be standardized and will vary depending on their surgeon. On the 30th postoperative day, the platform will send a final follow-up form. In the event of an emergency, they will receive the contact details of the Centre d'Optimisation des Flux Réseau (COFR) to ensure the continuity of their care.
15739268|NCT04948567|Other|split-dose of Magnesium Sulfate solution|purgative for bowel preparation
15739269|NCT04948567|Other|split-dose of PEG|purgative for bowel preparation
15739272|NCT04948541|Combination Product|osa treatment|different treatments can be included
15739273|NCT04948541|Other|no treatment|no treatment was undergone
15739274|NCT04948528|Other|Active Comparator: Surgery Pathology or Cystoscopy|Case group will be followed up with surgery pathology or cystoscopy.
15739275|NCT04948528|Other|Active Comparator: Clinical Diagnosis|Control group will be diagnosed in clinical.
15739276|NCT04948515|Diagnostic Test|laboratory test|genotyping of IL 17 and IL23
15739277|NCT04948515|Diagnostic Test|laboratory test|estimation of serum level of IL 17
15739278|NCT04948502|Device|SaExten Vena Cava Filter System|Subjects will undergo intervention, be implanted with a SaExten IVCF. IVCF will be retrieved within 90 days or indwelled permanently, depending on the existence of thrombosis and the evaluation of the operator.
15739279|NCT04948502|Device|Denali inferior vena cava filter|Subjects will undergo intervention, be implanted with a Denali IVCF. IVCF will be retrieved within 90 days or indwelled permanently, depending on the existence of thrombosis and the evaluation of the operator.
15739280|NCT04948489|Drug|norethindrone acetate (NETA)|5mg of the NETA capsule by mouth daily for 12 months
15739281|NCT04948489|Drug|Placebo|Placebo capsule everyday for 12 months
15739282|NCT04948476|Other|Standardized Dialysis and Structured Discontinuation (S2D2)|"Prescription to minimize dialysis-induced ischemia
~Cool dialysate (35.0◦C)
~Dialysate sodium of 145mmol/L
~Dialysate calcium of 1.5mmol/L
~Maximum ultrafiltration rate of 10mL/kg/hour (if no weight, maximum is 500mL/hour)
~Note: If dialysis machines cannot get to the specified values, values closest to these are acceptable.
~Structured dialysis discontinuation (all criteria met)
~Most recent pre-dialysis potassium <6mmo/L and bicarbonate >12mmol/L
~Most recent urine volume ≥1L/day OR last ultrafiltration on dialysis <1L/session
~If available, timed urine collection with result for mean creatinine and/or urea clearance >12mL/min"
15739283|NCT04948476|Other|Usual Care|Dialysis prescription ordered by their clinical team. Decisions on dialysis discontinuation will be left to individual clinicians and will not be guided by a standard protocol.
15739284|NCT04948463|Drug|Piperacillin and Tazobactam for Injection|Given if patient has no known allergies, until ANC recovery at 100mg/kg (max 4g) 6 hourly.
15739285|NCT04948463|Drug|Cefepime Injection|Given if patient has non life-threatening hypersensitivity (preferred option), until ANC recovery at 50mg/kg (max 2g) 8 hourly.
15739286|NCT04948463|Drug|Ceftazidime Injection|If non life-threatening hypersensitivity (second option), given until ANC recovery at 50mg/kg (max 2g) 8 hourly
15739287|NCT04948463|Drug|Vancomycin Injection|If life-threatening hypersensitivity given with ciprofloxacin, given until ANC recovery at 15mg/kg (max 500mg) 6 hourly
15739288|NCT04948463|Drug|Amikacin Injection|Given until ANC recovery at 18-22.5mg/kg (max 1.5g) daily in combination with other antibiotic/s.
15739289|NCT04948463|Drug|Ciprofloxacin|If life-threatening hypersensitivity given with vancomycin, given until ANC recovery at 10 mg/kg (max 400 mg) 12 hourly
15739290|NCT04948463|Drug|Piperacillin and Tazobactam for Injection|Given if patient has no known allergies at 100mg/kg (max 4g) 6 hourly, stopping 48 hours post-fever resolution.
15739291|NCT04948463|Drug|Cefepime Injection|If non life-threatening hypersensitivity (preferred option) at 50mg/kg (max 2g) 8 hourly, stopping 48 hours post-fever resolution
15739292|NCT04948463|Drug|Ceftazidime Injection|If non life-threatening hypersensitivity (second option) at 50mg/kg (max 2g) 8 hourly, stopping 48 hours post-fever resolution
15739293|NCT04948463|Drug|Vancomycin Injection|If life-threatening hypersensitivity given with ciprofloxacin at 15mg/kg (max 500mg) 6 hourly, stopping 48 hours post-fever resolution
15739294|NCT04948463|Drug|Amikacin Injection|At 18-22.5mg/kg (max 1.5g) daily in combination with other antibiotic/s, stopping 48 hours post-fever resolution
15739295|NCT04948463|Drug|Ciprofloxacin|If life-threatening hypersensitivity given with vancomycin at 10 mg/kg (max 400 mg) 12 hourly, stopping 48 hours post-fever resolution
15739296|NCT04948450|Behavioral|Physical activity intervention|Individual progressive resistance training with physiotherapists
15739297|NCT04948450|Behavioral|Cognitive stimulation intervention|Cognitive Stimulation Therapy with rehabilitation experts.
15739298|NCT04948450|Other|Reduce of metabolic and vascular risk factors|Metabolic and vascular risk factors of the intervention group will be evaluated by cardiologists and endocrinologists. The study subjects will be provided with information on the importance of reducing risk factors, guidance on lifestyle changes and prescribing treatment if necessary by cardiologist and endocrinologists. The targets for blood pressure is less than 120/90 mmHg and the targets for HbA1c is less than 7 %
15739299|NCT04948398|Drug|Guselkumab|Guselkumab 100 milligrams (mg) will be administered subcutaneously once every 8 weeks.
15739300|NCT04948385|Drug|Propofol|deep sedation with propofol +/- adjuvants such as midazolam, sufentanil, lidocaine and/or dehydrobenperidol
15739301|NCT04948385|Procedure|No sedation|No sedation
15739302|NCT04948372|Drug|Terlipressin treatment|Patients in the terlipressin group received a fixed dose of terlipressin added to usual care. Terlipressin was intravenously pumped at a fixed dose of 1.3μg/kg/hour for 24 hours.
15739303|NCT04948372|Drug|Usual care|Patients in the usual care group were treated with standard care, according to the international guidelines for the management of sepsis and septic shock.
15739304|NCT04948359|Other|Group I (The patients intubated with cuffed ETT of ID number 4.5)|Groups are classified according to endotracheal tube ID numbers. Inflating the endotracheal tube cuff with more than normal volume leads to decreased capillary blood flow and mucosal damage, while inflating the endotracheal tube cuff with less than normal volume leads to insufficient ventilation of the patient and an increase in the risk of pulmonary aspiration. The cuff pressure safety range is recommended between 20-30 cmH2O to prevent gas leakage and the risk of aspiration. We aimed to determine the optimal cuff volume that ensures airway safety in pediatric patients intubated with a 4.5 size inner diameter (ID) endotracheal cuff tube. Choosing the appropriate tube for endotracheal intubation is of great importance, especially in children. In our study, the transverse diameter of the subglottic airway will be measured by USG for the selection of the appropriate ETT to be used for each patient (the formulas for the selection of ETT in the literature will be used)
15756330|NCT04806919|Drug|Progesteron TID|increasing the dose
15739305|NCT04948359|Other|Group II (The patients intubated with cuffed ETT of ID number 5.0)|Groups are classified according to endotracheal tube ID numbers. Inflating the endotracheal tube cuff with more than normal volume leads to decreased capillary blood flow and mucosal damage, while inflating the endotracheal tube cuff with less than normal volume leads to insufficient ventilation of the patient and an increase in the risk of pulmonary aspiration. The cuff pressure safety range is recommended between 20-30 cmH2O to prevent gas leakage and the risk of aspiration. We aimed to determine the optimal cuff volume that ensures airway safety in pediatric patients intubated with a 5.0 size inner diameter (ID) endotracheal cuff tube. Choosing the appropriate tube for endotracheal intubation is of great importance, especially in children. In our study, the transverse diameter of the subglottic airway will be measured by USG for the selection of the appropriate ETT to be used for each patient (the formulas for the selection of ETT in the literature will be used)
15739306|NCT04948359|Other|Group III ( The patients intubated with cuffed ETT of ID number 5.5)|Groups are classified according to endotracheal tube ID numbers. Inflating the endotracheal tube cuff with more than normal volume leads to decreased capillary blood flow and mucosal damage, while inflating the endotracheal tube cuff with less than normal volume leads to insufficient ventilation of the patient and an increase in the risk of pulmonary aspiration. The cuff pressure safety range is recommended between 20-30 cmH2O to prevent gas leakage and the risk of aspiration. We aimed to determine the optimal cuff volume that ensures airway safety in pediatric patients intubated with a 5.5 size inner diameter (ID) endotracheal cuff tube. Choosing the appropriate tube for endotracheal intubation is of great importance, especially in children. In our study, the transverse diameter of the subglottic airway will be measured by USG for the selection of the appropriate ETT to be used for each patient (the formulas for the selection of ETT in the literature will be used)
15739307|NCT04948346|Other|diagnosed with ALS|diagnosed with ALS
15739308|NCT04948333|Drug|ABL001 40mg BID|One tablet of 40 mg will be taken orally twice a day (BID)
15739309|NCT04948333|Drug|ABL001 80mg QD|Two tablets of 40 mg will be taken orally once a day (QD)
15739310|NCT04948333|Drug|ABL001 200mg QD|Five tablets of 40 mg will be taken orally once a day (QD)
15739311|NCT04948307|Device|OXD01 digital therapy|OXD01 digital therapy, 1-2 times per week 15-30 minutes each time.
15739312|NCT04948307|Other|Standard of Care|sublingual buprenorphine/naloxone Medication-assisted treatment, the current standard for opioid addiction; the use of medications in combination with counseling
15739313|NCT04948294|Device|Channeled blade|In the present group, a tracheal tube was launched in the channel of the blade before tracheal intubation
15739314|NCT04948294|Device|Non-channeled blade|In the present group, a tracheal tube was not launched in the videolaryngoscope blade before tracheal intubation
15739315|NCT04948281|Other|no intervention|no intervention
15739316|NCT04948268|Behavioral|Adaptive messaging intervention|Psychological content and messages delivered regularly over an 8-week period via SMS. Psychological content will center on a single psychological strategy each week. Content and messages will be tailored using machine learning.
15739317|NCT04948268|Behavioral|Static messaging intervention|Psychological content and messages delivered regularly over an 8-week period via SMS. Psychological content will center on a single psychological strategy each week. There will not be any tailoring of messaging and content based on group or individual level data.
15739318|NCT04948268|Behavioral|Coaching|Human coaching to support intervention use and engagement via telephone calls, text or email
15739319|NCT04948268|Behavioral|Psychoeducational links|URLs containing brief psychoeducational information (one link per week).
15739320|NCT04948255|Other|Health and Safety Executive's (HSE) Management Standards Indicator Tool (MSIT) to measure work-related stress|Questionnaire
15739321|NCT04948229|Other|Blood serum samples|Blood serum samples will be taken.
15739322|NCT04948216|Other|No intervention|No intervention
15739323|NCT04948203|Drug|Sirolimus|Triangular-shaped tablet
15739324|NCT04948190|Behavioral|Testing with medical detection dogs|Participants will be screened by medical detection dogs. In phase 2, participants may be asked to wear clothing samples collected in phase 1, as part of dog training procedures. In subsequent study parts, participants will wear their own clothing.
15739325|NCT04948164|Drug|sumatriptan 85mg and naproxen sodium 500mg|Subjects took 1 tablet of the study drug (each containing sumatriptan 85mg and naproxen sodium 500mg) within 1h of an acute migraine attack of mild severity, and if the headache progressed to moderate severity within 2 hours, they could take the remedial drug phenol chai (each containing acetaminophen 500mg and caffeine 65mg).
15739326|NCT04948164|Drug|Placebo|"subjects were given one tablet of placebo within 1 h of an acute migraine attack with mild severity, and if the headache progressed to moderate severity within 2 hours, they were given the remedial drug phenol chai (each tablet contains acetaminophen 500 mg and caffeine 65 mg)."
15739327|NCT04948151|Drug|Sildenafil|Patients will apply 2-gram applications up to 9 times per month.
15739328|NCT04948151|Drug|Placebo|Patients will apply 2-gram applications up to 9 times per month
15739329|NCT04948138|Dietary Supplement|Glutamine oral supplementation|Oral supplementation with 10-15 g/day of glutamine (adjusted for weight and plasma concentrations).
15739330|NCT04948125|Drug|camrelizumab|200 mg intravenous (IV) camrelizumab on Day 1 and Day 15 of each 28-day cycle.
15739331|NCT04948125|Drug|Apatinib Mesylate|250 mg qd
15739334|NCT04948099|Drug|VIB1116|VIB1116
15739335|NCT04948099|Drug|Placebo|Placebo
15739336|NCT04948073|Other|Dynamic neuromuscular stabilization approach|The experimental group will follow a DNS exercise protocol based on previous procedure for a whole period of 6 weeks (three 50-min sessions per week) in addition the conventional treatment.
15739337|NCT04948073|Other|Conventional treatment|Patients from both groups will receive a conventional 6-week treatment programme (18 treatment sessions, three a week, for 30-40min duration).
15739392|NCT04947514|Other|Placebo (topical saline)|The untreated breast will receive topical saline.
15739417|NCT04947306|Device|Tetragraph® (Senzime, Uppsala, Sweden)|The Tetragraph® is a recently marketed electromyographic neuromuscular monitor that uses a disposable electrode array (TetraSens) that combines stimulating and recording electrodes
15739338|NCT04948060|Other|Enhanced lung cancer screening services|A theoretically sound and evidence-based, multi-component implementation strategy will be applied which includes care quality benchmarking and regular performance feedback, academic detailing provided by specially trained primary care clinicians, practice facilitation provided by trained and certified Practice Facilitators (PFs), health information technology (HIT) support, and facilitated professional networking to promote the cross-pollination and rapid dissemination of solutions and best practices in primary care settings
15739339|NCT04948047|Diagnostic Test|Pathological examinations as the golden diagnosis criteria|Pathological diagnosis, as the golden standard for diagnosing pulmonary nodules, is achieved by two experienced pathologists and validated by the third senior pathologist.
15739340|NCT04948047|Diagnostic Test|Breath test combined with computed tomography|"Exhaled breath of each participant will be collected with Tedlar bags. The volatile organic compounds will be detected by a high-resolution high-pressure photon ionization time-of-ﬂight mass spectrometry (HPPI-TOFMS).
~The Imaging markers of pulmonary nodules, including the size, three-dimensional shape, and appearance characteristics, are derived from the chest computed tomography within 2 weeks before surgery resection."
15739341|NCT04948034|Radiation|Stereotactic Ablative Radiotherapy (SABR)|"We plan to irradiate as many metastatic lesions as possible, in the precondition that normal tissues can tolerate.
~Target dose will be adjusted depending on site of the lesion and organs at risk (BED > 100Gy).
~Treatment schedule is once per day and five days per week. Sequence of irradiation for multiple metastases is at the discretion of the investigators based on their experience."
15739342|NCT04948034|Drug|Fruquintinib|Starts within two weeks upon SABR completion: 5mg, d1-14, qd; Continued until disease progression, unacceptable toxicity or patient withdrawal.
15739343|NCT04948034|Drug|Tislelizumab|Starts within one week upon SABR completion: 200mg, d1, q3w; the dosing will continue for up to two years until disease progression, unacceptable toxicity or patient withdrawal.
15739344|NCT04948008|Biological|IBI306|IBI306 is a kind of Proprotein convertase subtilisin/kexin 9
15739345|NCT04947995|Device|ctDNA multi-omics test|The ctDNA multi-omics test for gastric cancer will be built based on low-pass WGS, methylation, and target region sequencing.
15739346|NCT04947982|Other|carbon dioxide|carbon dioxide insufflation pressure
15739347|NCT04947969|Device|laser acupuncture|This study will use German-made low-level laser pen (Al-Ga-As diode laser, 810nm, NIR, Physiolaser Olympic Basic, RJ laser). The parameters are power of 100mW, frequency of Bahr, apply on acupoint. Well will irradiate each point for 2 J. Each patient will receive this treatment six times for one week.
15739348|NCT04947956|Drug|Camrelizumab|The camrelizumab-based treatment will be determined by the investigator.
15739349|NCT04947917|Procedure|SpotTM Tattoo Ink|Ink injection
15739350|NCT04947904|Other|Reduction of the patient's fluid intake during the first 7 days|The volume of fluids infused to the patient will be reduced by the doctor in charge of the patient for the first 7 days of the patient's stay in the intensive care unit according to a protocol with instructions to reduce fluid intake as far as possible in terms of maintenance fluids, dilution of medication and artificial nutrition. This protocol will be begun immediately following the patient's inclusion on Day 1 and pursued for 7 days after inclusion (i.e. from Day 1 - to Day 7). The fluid restriction strategy does not involve the administration of any medication (i.e. diuretics). A clinical pharmacist will help the intensive care teams apply the fluid restriction protocol with a daily check. If the restrictive strategy leads to hypovolemia and / or a electrolyte anomaly (sodium, potassium, chloride, etc.), the physician in charge will be authorised to treat these anomalies in conformance with the protocol recommendations.
15739351|NCT04947891|Procedure|Intensive recovery management|Intensive recovery management includes 3 parts: (1) Preoperative analgesia and airway evaluation. (2) The protection and reconstruction of the musculo-ligamentous complex during the surgery, the safe intubation, and the local infiltration anesthesia during surgery. (3) Collar free, multimodal analgesia, airway management, and early recovery after surgery.
15739352|NCT04947878|Other|Prompt list|The patients in the intervention group will review a prompt list before their visit.
15739353|NCT04947865|Other|Peripheral nerve stimulation|Electrical stimulation of peripheral nerves to measure resulting gait kinematics and surface muscle activity
15739354|NCT04947865|Device|Commercial knee brace|Knee brace used to limit knee mobility in healthy individuals to imitate stroke survivors and measure resulting gait kinematics and surface muscle activity.
15739355|NCT04947852|Device|Investigation Mask|Oronasal bilevel continuous positive airway pressure mask fitted by the investigational staff
15739356|NCT04947852|Device|Comparator Mask|Oronasal bilevel continuous positive airway pressure mask fitted by the investigational staff
15739357|NCT04947826|Procedure|HAIC (Hepatic arterial infusion chemotherapy)|For the HAIC procedure, a 5F catheter was introduced using the Seldinger technique through the femoral artery or the radial artery. Then, angiographic surveys of the celiac trunk and superior mesenteric artery were performed. According to tumor size, location, and arterial supply, the catheter or a 2.7F microcatheter was advanced into the hepatic artery at the level of selective segmental, lobar, or whole liver. The catheter or microcatheter was connected to an external infusion pump. The following regimen of modified FOLFOX was administered: oxaliplatin, 85mg/m2 for 2 hours; leucovorin, 400mg/m2; and 5-fluorouracil, 2400mg/m2 for 44-46 hours. After HAIC treatment, the catheter or microcatheter, and the sheath were removed.
15739358|NCT04947826|Drug|HLX10 (PD-1 antibody)|PD-1 antibody with proven efficacy in advanced hepatocellular carcinoma
15739359|NCT04947826|Drug|HLX04 (VEGF antibody)|Combination of PD-1 antibody and VEGF antibody might promote the efficacy of HAIC in hepatocellular carcinoma with major portal vein thrombosis.
15739360|NCT04947826|Drug|Placebo|Placebo
15739361|NCT04947800|Device|Pulmonary rehabilitation program + EA Lung Mu-Shu+ St36|Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lung Mu-Shu points and St36 points
15739362|NCT04947800|Device|Pulmonary rehabilitation program + Lv7/Gb26|Standard of care pulmonary rehabilitation program plus electro-acupuncture with mA electricity at varying frequencies to the Lv7/Gb26 points
15739415|NCT04947332|Procedure|Auto-inoculation|A wart will be excised from the body, minced and will be inoculated in a subcutaneous pocket on forearm.
15739416|NCT04947319|Drug|Tirabrutinib|Tirabrutinib 480 mg, taken orally, once a day on an empty stomach. Tirabrutinib treatment may be continued until disease progression or clinically unacceptable toxicity is observed.
15739363|NCT04947787|Behavioral|Physical activity referral scheme (PARS)|Participants of the intervention group will receive brief physician advice and be referred to an exercise professional (e.g., physiotherapist, sports therapist) for a more intensive counseling intervention. The counseling intervention consists of an initial assessment, individual physical activity counseling (360'), a final assessment after 12 weeks, and a follow-up assessment after 24 weeks.
15739364|NCT04947787|Behavioral|Physical activity advice (PAA)|Participants of the control group will only receive brief physician advice regarding the promotion of physical activity and as an information sheet with tips on how to adopt a more physically active lifestyle.
15739365|NCT04947774|Radiation|Prophylactic Cranial Irradiation|The extensive-stage SCLC patients will receive prophylactic cranial irradiation ±immunotherapy after standard first-line chemotherapy combined with immunotherapy, until disease progression or death
15739366|NCT04947761|Drug|modified Tian Wang Bu Xin Dan hydrogel patch|modified Cheonwangbosimdan hydrogel patch (one patch/24 hours) applied to Shenque point for 4 days (1 patch daily beginning 2 days preoperative, and continued at 1 patch daily until 2 days postoperatively)
15739367|NCT04947761|Other|placebo patch|placebo patch (one patch/24 hours) applied to Shenque point for 4 days (1 patch daily beginning 2 days preoperative, and continued at 1 patch daily until 2 days postoperatively)
15739368|NCT04947748|Other|Oral versus intravenous administration of antibacterial treatment|Mode of administration of antibacterial treatment
15739369|NCT04947735|Device|Novel spectacle lens design|Use of single vision, impact resistant spectacle lenses may reduce the rate of progression of juvenile myopia
15739370|NCT04947735|Device|Spectacle lenses|Single vision, impact resistant spectacle lenses
15739371|NCT04947722|Behavioral|PREVENT Program|A standardized PREVENT educational program will be offered to each intervention LTC home and health-care staff. The curricula includes video modules with fracture-prevention care recommendations and an orientation to the Fracture Prevention Toolkit. Using the Fracture Risk Scale (i.e., a clinical decision support tool embedded in the RAI-MDS 2.0), the LTC team will identify residents at high-risk for fracture and will implement the fracture prevention recommendations into care plans on an individual resident basis.
15739372|NCT04947709|Behavioral|Physical Activity|The main structure of the physical activity program will focus on increasing physical activity. Physical activity will initially start at a duration of 15-30 minute bouts, and at rate of perceived exertion levels of ≥12 (somewhat hard). Over the course of the intervention, goals will be set to progress to 60 minutes of continuous physical activity, at a rate of perceived exertion level of 12-14 (somewhat hard). Participants will be instructed on the use of the ratings of the perceived exertion scale (Borg's RPE 6-20 scale). Participants will be instructed to walk, or engage in other forms of leisure-time physical activity to achieve these goals (cycling, running, swimming, etc). As the adolescent and young adults' health and fitness status improve, frequency, intensity, and session duration will be modified accordingly during weekly support calls. Moreover, goals will be responsive to the most recent week's achieved minutes and rate of perceived exertion.
15739373|NCT04947696|Diagnostic Test|Blood sampling|Blood sampling preoperatively and sequentially up to 30 days post op
15739374|NCT04947670|Procedure|Renal arteriography followed by renal denervation|Renal arteriography followed by renal denervation
15739375|NCT04947670|Procedure|Sham Renal arteriography|Renal arteriography only
15739376|NCT04947644|Procedure|Thoracic epidural analgesia|After negative response, 10 ml of 0.25% bupivacaine will be injected as a bolus dose in the epidural catheter in 5ml divided aliquots at 5min intervals, 30 min before the induction of general anesthesia and the patient will be turned to the supine position. Sensory block will be assessed in operated side by loss of pinprick sensation in midclavicular line every 2 min. After 15min, if the sensory block level was still below T5, an additional 5ml bupivacaine was given. Then followed by continuous infusion of bupivacaine 0.125% at a rate of 6 ml/h that will be started before skin incision and the dose was increased in 2 ml/h increments up to 10 ml/h for 24 hours. Rate adjustment according to pain score and side effects
15739377|NCT04947644|Procedure|Ultrasound guided continuous erector spinae plane block|After verifying the correct space with hydrodissection by 5mL of saline 0.9%, lifting erector spinae muscle off the bony shadow of the transverse process, a catheter was inserted was inserted 3 cm beyond the needle tip and 10 ml of 0.25% bupivacaine will be injected as a bolus dose in the epidural catheter in 5ml divided aliquots at 5min intervals, 30 min before the induction of general anesthesia and the patient will be turned to the supine position. Sensory block will be assessed in operated side by loss of pinprick sensation in midclavicular line every 2 min. After 15min, if the sensory block level was still below T5, an additional 5ml bupivacaine was given. Then followed by continuous infusion of bupivacaine 0.125% at a rate of 6 ml/h that will be started before skin incision and the dose was increased in 2 ml/h increments up to 10 ml/h for 24 hours. Rate adjustment according to pain score and side effects
15739378|NCT04947631|Drug|DKF-313|Combination of dutasteride 0.5 mg and tadalafil 5 mg once daily for 48 weeks
15739379|NCT04947631|Drug|Dutasteride|Dutasteride 0.5 mg once daily for 48 weeks
15739380|NCT04947631|Drug|Tadalafil|Tadalafil 5 mg once daily for 48 weeks
15739381|NCT04947631|Drug|DKF-313 placebo|Once daily for 48 weeks
15739382|NCT04947631|Drug|Dutasteride placebo|Once daily for 48 weeks
15739383|NCT04947631|Drug|Tadalafil placebo|Once daily for 48 weeks
15739384|NCT04947592|Drug|Fluconazole 150 mg|fluconazole 150 MG once daily for 14 days
15739387|NCT04947566|Drug|Comparison of Efficacy of Naproxen versus Ibuprofen|Comparison of Efficacy of Naproxen Versus Ibuprofen in the Management of Post-Operative Endodontic Pain in Teeth with Irreversible Pulpitis
15739388|NCT04947553|Drug|AXS-05 (dextromethorphan-bupropion)|AXS-05 tablets, taken twice daily
15739389|NCT04947527|Drug|Test varnish|A maximum of 0.2 mL will be applied to the teeth with a dental brush. Test or control varnish will be applied topically 4 times per year following enrollment and at each 3 to 4-month intervals.
15739390|NCT04947527|Drug|Placebo|A maximum of 0.2 mL will be applied to the teeth with a dental brush. Test or control varnish will be applied topically 4 times per year following enrollment and at each 3 to 4-month intervals.
15739391|NCT04947514|Drug|Tranexamic acid|Topical tranexamic acid (1000mg) will be administered to the raw surface of the breast prior to closure of the incisions.
15757510|NCT04797767|Drug|Venetoclax|Given PO
15739393|NCT04947501|Drug|Cyclophosphamide|"Administration of CTV - cycles 1 and 4
~Days 1 & 2: Cyclophosphamide 70 mg/kg/day (2100 mg/m2/day for patients >10 years old), IV over 6 hrs.
~Mesna 70 mg/kg (2100 mg/m2/day for patients >10 years old) , by 24-hr IV infusion, starting with the cyclophosphamide infusion.
~Days 1-4: Topotecan 2 mg/m2/day, IV over 30 minutes. Day 1: Vincristine 0.067 mg/kg (or 2 mg/m2, whichever is less) by IV piggyback; maximum dose is 2 mg.
~******* Administration of CDV - cycle 3 Days 1 & 2: Cyclophosphamide 70 mg/kg/day ((2100 mg/m2/day for patients >10 years old), IV over 6 hrs.
~Mesna 70 mg/kg ((2100 mg/m2/day for patients >10 years old), by 24-hr IV infusion, starting with the cyclophosphamide infusion.
~Days 1-3: Doxorubicin 25 mg/m2/day, by 24-hr IV infusion (total dose over 72 hr is 75 mg/m2).
~Days 1-3: Vincristine 0.67 mg/m2/day or 0.022 mg/kg/day (whichever is less), by 24-hr IV infusion (total dose over 72 hr is 2 mg/m2 or 0.067 mg/kg); maximum dose is 0.67 mg/day, or 2mg over 72 hr."
15739394|NCT04947501|Drug|Topotecan|"Administration of CTV - cycles 1 and 4
~Days 1 & 2: Cyclophosphamide 70 mg/kg/day (2100 mg/m2/day for patients >10 years old), IV over 6 hrs.
~Mesna 70 mg/kg (2100 mg/m2/day for patients >10 years old) , by 24-hr IV infusion, starting with the cyclophosphamide infusion.
~Days 1-4: Topotecan 2 mg/m2/day, IV over 30 minutes. Day 1: Vincristine 0.067 mg/kg (or 2 mg/m2, whichever is less) by IV piggyback; maximum dose is 2 mg."
15739395|NCT04947501|Drug|Vincristine|"Administration of CTV - cycles 1 and 4
~Days 1 & 2: Cyclophosphamide 70 mg/kg/day (2100 mg/m2/day for patients >10 years old), IV over 6 hrs.
~Mesna 70 mg/kg (2100 mg/m2/day for patients >10 years old) , by 24-hr IV infusion, starting with the cyclophosphamide infusion.
~Days 1-4: Topotecan 2 mg/m2/day, IV over 30 minutes. Day 1: Vincristine 0.067 mg/kg (or 2 mg/m2, whichever is less) by IV piggyback; maximum dose is 2 mg."
15739396|NCT04947501|Drug|Doxorubicin|"Administration of CDV - cycle 3 Days 1 & 2: Cyclophosphamide 70 mg/kg/day ((2100 mg/m2/day for patients >10 years old), IV over 6 hrs.
~Mesna 70 mg/kg ((2100 mg/m2/day for patients >10 years old), by 24-hr IV infusion, starting with the cyclophosphamide infusion.
~Days 1-3: Doxorubicin 25 mg/m2/day, by 24-hr IV infusion (total dose over 72 hr is 75 mg/m2).
~Days 1-3: Vincristine 0.67 mg/m2/day or 0.022 mg/kg/day (whichever is less), by 24-hr IV infusion (total dose over 72 hr is 2 mg/m2 or 0.067 mg/kg); maximum dose is 0.67 mg/day, or 2mg over 72 hr."
15739397|NCT04947501|Drug|Ifosfamide|"Administration of ICE - cycle 2
~Days 1-5: Ifosfamide 1500 mg/m2/day, IV over 6 hrs. Mesna 1500 mg/m2/day, by 24-hr IV infusion, starting with the ifosfamide infusion.
~Days 1-2: Carboplatin 400 mg/m2/day, IV over 1 hr. Days 1-5: Etoposide 100 mg/m2/day, IV over 2 hrs."
15739398|NCT04947501|Drug|Etoposide|"Administration of ICE - cycle 2
~Days 1-5: Ifosfamide 1500 mg/m2/day, IV over 6 hrs. Mesna 1500 mg/m2/day, by 24-hr IV infusion, starting with the ifosfamide infusion.
~Days 1-2: Carboplatin 400 mg/m2/day, IV over 1 hr. Days 1-5: Etoposide 100 mg/m2/day, IV over 2 hrs."
15739399|NCT04947501|Drug|Carboplatin|"Administration of ICE - cycle 2
~Days 1-5: Ifosfamide 1500 mg/m2/day, IV over 6 hrs. Mesna 1500 mg/m2/day, by 24-hr IV infusion, starting with the ifosfamide infusion.
~Days 1-2: Carboplatin 400 mg/m2/day, IV over 1 hr. Days 1-5: Etoposide 100 mg/m2/day, IV over 2 hrs."
15739400|NCT04947501|Drug|Mesna|"Administration of CTV - cycles 1 and 4 Mesna 70 mg/kg (2100 mg/m2/day for patients >10 years old) , by 24-hr IV infusion, starting with the cyclophosphamide infusion.
~Administration of ICE - cycle 2 Mesna 1500 mg/m2/day, by 24-hr IV infusion, starting with the ifosfamide infusion.
~Administration of CDV - cycle 3 Mesna 70 mg/kg ((2100 mg/m2/day for patients >10 years old), by 24-hr IV infusion, starting with the cyclophosphamide infusion."
15739401|NCT04947488|Dietary Supplement|Bioarginina C|Dietary supplement vials
15739402|NCT04947475|Behavioral|SBIRT|First, the BI is designed to inform potential participants on the risks of substance misuse, abuse, and dependency by illustrating the potential hazards and adverse health consequences. Second, the BI aims to motivate potential participants to reduce risky behavior (e.g., continued drug use) and seek treatment for their substance dependence disorder. In our BI, we will provide evidence-based information on Opioid Agonist Therapy (OAT) that is available to them in the community upon release. We will inform them of the risks and benefits of OAT and explain to them how OAT can be accessed in the community. OAT is provided at no cost to Ukrainian citizens with opioid dependence. The BI will last approximately 20 minutes and time will be made available for them to ask questions. The BI will not be audio recorded.
15739403|NCT04947462|Device|Chronically Implanted Neural and Muscular Interface|Participants will be chronically implanted with neural and muscular interfaces to characterize proprioceptive sensations using Functional Electrical Stimulation (FES).
15739404|NCT04947449|Device|fractional CO2 laser|Standard of care laser treatment of burn-related injuries will be performed. This protocol assesses the effects of those treatments on skin blood flow and sweating responses.
15739405|NCT04947436|Device|High Frequency Chest Wall Oscillation|The HFCWO aims to mobilize the secretions to the pharynx to allow the patient to expel the secretions. However, many ALS patients are unable to expel their secretions due to atrophied expiratory muscles. The HFCWO device uses a small air compressor with a vest that wraps around the chest to induce airflows that pull secretions from the walls of the airways, thin the secretions and move them up the airways towards the larger airways and pharynx.
15739406|NCT04947436|Device|Mechanical insufflation/exsufflation|A noninvasive therapy, removes secretions in patients who have an ineffective cough because their peak cough flows are less than 270 L/min. This device applies a positive pressure to the airway and rapidly switches to a negative pressure applied to the airway. The rapid switch between the two types of pressure simulates a natural cough, thus assisting with expulsion of the secretions.
15739407|NCT04947423|Drug|DPI-386 Nasal Gel|Subjects will self-administer DPI-386 Nasal Gel or Placebo
15739408|NCT04947423|Drug|Placebo|Subjects will self-administer DPI-386 Nasal Gel or Placebo
15739409|NCT04947410|Device|CPAP or nasal dilators|CPAP = active comparator nasal dilators = placebo comparator
15739410|NCT04947397|Diagnostic Test|Pupillometry|Pupillometry prior to extubation
15739411|NCT04947384|Diagnostic Test|To discern micro-RNA specific for right and left heart induced PH|While undergoing other procedures, the investigators will be collecting a total of three blood samples. The first sample will be obtained on arterial cannulation before the initiation of the intervention, the second sample will be collected upon the end of the procedure prior to leaving the procedure room, and the third sample will be collected on the day of discharge from the hospital.
15739412|NCT04947371|Drug|Anlotinib Hydrochloride|Oral anlotinib hydrochloride 12 mg/d
15739413|NCT04947345|Drug|Remimazolam Besylate|Remimazolam Besylate are used as sedatives for subjects in this arm.
15739414|NCT04947345|Drug|Propofol|Propofol are used as sedatives for subjects in this arm.
15739418|NCT04947306|Device|TOF Watch® SX (Organon Teknika B.V., Boxtel, Holland)|The TOF Watch® SX is a common used neuromuscular monitor
15739419|NCT04947293|Other|Physical activity|Both groups will practice a physical activity adapted to their motor skills. They will have two group sessions (maximum 5 people per group) in a face-to-face setting, and one independent session at home supported by a video, each week. These programs last 12 weeks, and will be supervised by the same person, a physiotherapist.
15739420|NCT04947280|Radiation|Fractionated Stereotatic Radiation Therapy|Participants prescribed to receive 9 Gy x 3 or 10 Gy x3 image-guided fractionated stereotatic radiation therapy.
15739421|NCT04947267|Drug|3% Mepivacaine Hydrochloride|1.8 ml of 3% mepivacaine (3% Scandonest, Septodont) was administered to Group B patients. Inferior alveolar nerve block was administered to both the groups. Rubber dam was then placed in the desired quadrant. Selected carious mandibular was restored and seven pulpal oxygen saturation spot readings were taken for an hour.
15739422|NCT04947267|Drug|2% Mepivacaine with 1:100,000 epinephrine|1.8 ml of 2% mepivacaine with 1:100,000 epinephrine (2% Scandonest Special, Septodont) was administered to Group A patients. Inferior alveolar nerve block was administered to both the groups. Rubber dam was then placed in the desired quadrant. Selected carious mandibular was restored and seven pulpal oxygen saturation spot readings were taken for an hour.
15739423|NCT04947254|Drug|Abiraterone Acetate|Given PO
15739424|NCT04947254|Drug|Antiandrogen Therapy|Given ADT
15739425|NCT04947254|Drug|Apalutamide|Given PO
15739426|NCT04947254|Procedure|Biopsy|Undergo biopsy
15739427|NCT04947254|Drug|Niraparib|Given PO
15739428|NCT04947254|Drug|Prednisone|Given PO
15739429|NCT04947254|Radiation|Radiation Therapy|Undergo radiation therapy
15739430|NCT04947241|Drug|PD-1 inhibitor+ Gemcitabine + Cisplatin|"Before surgery, patients will receive therapy as follows:
~PD-1 inhibitor: 240mg (day1) , intravenous, Q3W, 2cycles; cisplatin: 80 mg/m2(day1), intravenous , intravenous, Q3W, 2cycles Gemcitabine: 1000mg/m2(day1and day8), intravenous, Q3W, 2cycles"
15739431|NCT04947228|Device|trackPAD|TrackPAD is a smartphone app to provide PAD-specific support for SET
15739432|NCT04947215|Diagnostic Test|stress biomarkers|used to estimate the reference values of putative biomarkers of birth stress such asCTnT, CTnI, copeptin, NT-proBNP and hs-CRP in the cord blood of full term neonates
15739433|NCT04947202|Device|Hernioplasty|Hernioplasty is the repair of the defect using mesh patches.
15739434|NCT04947189|Drug|Seviteronel-D (Seivteronel in combination with dexamethasone)|Use of Seviteronel-D (Serivteronel and dexamethasone) in the treatment of androgen receptor positive solid tumours.
15739435|NCT04947189|Drug|Docetaxel|Use of docetaxel chemotherapy for solid tumours
15739436|NCT04947176|Dietary Supplement|Supplement|200mg C15:0 once daily
15739437|NCT04947176|Other|Placebo|Matching placebo once daily
15739438|NCT04947163|Device|Inspiratory Muscle Training|Participants will perform home-based IMT twice daily [once in the morning (between 7:00 and 12:00 am) and once in the evening (between 16:00 and 21:00 pm)], for 8 consecutive weeks, using a mechanical pressure threshold loading device. In addition, participants in this group will try to increase the inspiratory resistance when the participants feel that 30 breaths are achievable with ease or if the paeticipants could reach 35 consecutive breaths.
15739439|NCT04947163|Device|Sham IMT|Participants will perform 60 slow breaths once daily at a load setting of 0 (corresponding to ~15% [baseline] MIP), using the same device as the IMT group. For the sham group, the ability to adjust the training load will be prevented using sticky tape applied to the device's load adjuster.
15739440|NCT04947150|Behavioral|Location-triggered notification|"If participants are randomized to have this component ON, the app will send the notification when the participant's smartphone is within a 50-meter geofence around designated grocery stores. No more than one notification will be sent per week. Mindfulness of program goals in the moment of decision making is expected to facilitate program-consistent food purchasing behaviors. Participants assigned to have location-triggered message delivery OFF will receive their weekly recommendations and reminders messages at standard times throughout the week. The content of the messages will not differ according to whether this component is ON vs. OFF."
15739441|NCT04947150|Behavioral|Reflections on benefits of change|Participants will reflect on anticipated benefits of purchasing healthy foods, consistent with motivational interviewing and self-determination theory. Message content will be personalized as follows: During the initial workshop, all participants will complete an exercise identifying benefits of healthy eating that are important to them. Message content will then be programmed to be personalized according to anticipated rewards important to that participant. Participants assigned to have this intervention component OFF will not have content about anticipated benefits of change added to any messages.
15739442|NCT04947150|Behavioral|Coach monitoring|Coaches will monitor participant food purchases via a dashboard for viewing purchase data, and send messages designed to provide feedback and enhance supportive accountability for program goals. The messages will provide reinforcement for purchases consistent with program goals and express concern for areas in which adherence is low. Participants assigned to have this component OFF will not receive these extra messages or phone calls, and their food purchases will only be viewed by research staff for research outcome assessment purposes.
15739443|NCT04947150|Behavioral|Household support|If participants are assigned to have household support ON, one adult in the household will receive weekly text messages designed to elicit support for changing food purchases. In addition, the index participant and household member will be invited to participate in one extra workshop session and three brief coaching calls focused on household support. If participants are assigned to have this OFF, household members will have no program involvement.
15739444|NCT04947137|Drug|Tc99m tilmanocept|Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
15739482|NCT04946825|Behavioral|Continue electronic cigarettes|Participants will receive instruction and text message support to continue using electronic cigarettes after they quit combustible cigarettes.
15739483|NCT04946812|Other|Split-belt treadmill training|18 sessions of SB-TM training, where the velocity of the belt will be adjusted to the over-ground speed of the subject, and will be reduced on the least affected side by 25%.
15761080|NCT04767984|Drug|Atorvastatin Calcium|Given PO
15739447|NCT04947111|Diagnostic Test|Estimate the distribution of antibodies by serotype by Dengue virus in areas of low and high incidence of dengue|"Indirect IgG ELISA to estimate seroprevalence: The seropositivity will be evaluated with the Indirect IgG ELISA following the instructions of the Panbio E-DEN 01 G manufacturer, which has a specificity of 98% and a sensitivity of 100%. In brief, 10 microliters of participant serum will be used for each assay. Each kit provides a positive and negative control, as well as three calibrators, with the respective values for quality control. Samples will be classified as positive, negative or indeterminate according to the cut-off point for each ELISA kit.
~Neutralizing antibody titers serotype-specific: To establish the type of humoral immunity that the selected city presents, the measurement of the neutralizing antibody titers will be carried out by means of the neutralization test by reducing the number of lytic plaques to 50% (PRNT50%) , using Vero cells and the following reference strains for each serotype: DENV-1 (HAWAI), DENV-2 (NEW GUINEA), DENV-3 (H-887) and DENV-4 (H-24)"
15739450|NCT04947072|Procedure|Erector Spinae Plane Block|The block will be performed at the level of T9 on the site that will be operated and patient will be given Bupivacaine isobaric 0.5% 25 ml with epinephrine 1:200.000
15739451|NCT04947072|Procedure|Spinal anesthesia|Patient will be given bupivacaine hyperbaric 0.5% 16-18 mg at the level of L3-L4 or L4-L5
15739452|NCT04947059|Drug|Gemcitabine Hydrochloride combined with continuous saline irrigation|Immediate single intravesical instillation with gemcitabine combined with continuous saline irrigation in bladder cancer patients who are treated with a transurethral resection of the tumor
15739453|NCT04947059|Drug|Epirubicin Hydrochloride combined with continuous saline irrigation|Immediate single intravesical instillation with epirubicin combined with continuous saline irrigation in bladder cancer patients who are treated with a transurethral resection of the tumor
15739454|NCT04947033|Drug|TJ210001 Injection|The test drug TJ210001 will be preset with 5 escalation dose levels: 0.3mg/kg, 1mg/kg, 3mg/kg, 10mg/kg and 15mg/kg, administered once a week.
15739455|NCT04947020|Drug|Metformin|Metformin use before operation due to previously diagnosed diabetes.
15739456|NCT04947007|Drug|Bupivacaine hydrogen chloride (HCl) 0.025 % in 15+15 ML Injection|In this group, US guided suprascapulary and axillary block will be performed with 15 ml +15 ml 0.025% bupivacaine for each block site using a 22 gauge 10 mm block needle.
15739457|NCT04947007|Drug|Bupivacaine HCl 0.025 % in 10+10 ML Injection|In this group, US guided suprascapulary and axillary block will be performed with 10 ml +10 ml 0.025% bupivacaine for each block site using a 22 gauge 10 mm block needle.
15739458|NCT04947007|Drug|Bupivacaine HCl 0.025 % in 5+5 ML Injection|In this group, US guided suprascapulary and axillary block will be performed with 5 ml +5 ml 0.025% bupivacaine for each block site using a 22 gauge 10 mm block needle.
15739459|NCT04947007|Drug|Isotonic solution|In this group, US guided suprascapulary and axillary block will be performed with isotonic solution
15739460|NCT04946994|Behavioral|HIIT|The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
15739461|NCT04946994|Behavioral|CME|The participant will walk/jog for 50 continuous minutes at 55% VO2peak. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 4 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
15739462|NCT04946981|Dietary Supplement|Turmipure Gold®|TPG: Turmipure GOLD® - 1 capsule per day - as prescribed
15739463|NCT04946981|Dietary Supplement|Placebo|Placebo: colored acacia gum - 1 capsule per day - as prescribed
15739464|NCT04946968|Drug|Oral Dacomitinib|All subjects will receive the open-label Dacomitinib as tablets for oral self-administration on a continuous daily basis at a dose of 30 mg for one cycle. For subjects eligible for dose titration after Cycle 1, and after shared patient and investigator decision, these subjects will receive Dacomitinib 45 mg orally on a continuous daily basis.
15739466|NCT04946942|Behavioral|Collaborative Healthcare Encounters with Caregivers (CHEC)|CHEC is a brief checklist designed to identify family caregivers' unmet needs and concerns.
15739467|NCT04946942|Behavioral|Usual Care|Attendance at primary care appointments as usual.
15739468|NCT04946929|Drug|Ticagrelor Oral Tablet [Brilinta]|Ticagrelor, 2-3mg/kg, 12h, p.o.
15739469|NCT04946929|Drug|Low molecular weight heparin|half amount low molecular weight heparin
15739470|NCT04946916|Diagnostic Test|blood sample taken|Comparaison of Neurofilament light chain serum concentration between the arms
15739471|NCT04946903|Drug|RLD2007|Take it once per period.
15739472|NCT04946903|Drug|RLD2008|Take it once per period.
15739473|NCT04946903|Drug|HCP1902|Take it once per period.
15739474|NCT04946890|Drug|MRX2843|MRX2843 is treated at 80mg/d, 120mg/d and 180mg/d respectively
15739475|NCT04946877|Diagnostic Test|IQ assessment using Wechsler intelligence scale for children third edition (WISC-III)|IQ assessment using Wechsler intelligence scale for children third edition (WISC-III): is consists of several subtests, each classified into a verbal or performance scale .
15739476|NCT04946864|Drug|APG-2575|APG2575 monotherapy
15739477|NCT04946864|Drug|Palbociclib|combination APG2575+pablociclib
15739478|NCT04946838|Device|DS5 electrical stimulator|TENS
15739479|NCT04946825|Drug|Nicotine replacement therapy patch|The nicotine patch is attached to the participant's skin and provides a slight constant stream of nicotine. The smaller dose is meant to reduce nicotine dependence.
15739480|NCT04946825|Drug|Nicotine replacement therapy lozenge|The nicotine lozenge contains small amounts of nicotine, which a participant slowly dissolves in their mouth. Like the patch, the smaller dose is meant to reduce nicotine dependence.
15739481|NCT04946825|Behavioral|Quit electronic cigarettes|Participants will receive instruction and text message support to quit electronic cigarettes when they quit combustible cigarettes.
15739484|NCT04946799|Behavioral|Low-intensity training combined with blood flow restriction (LI-BFR)|Participants (n=20) receives low intensity exercise intervention on a cycle ergometer (at 40% of heart rate reserve), with compression belts attached on both thighs, during exercise the belts are inflated with 50% of the participant's arterial occlusion pressure. Exercise is conducted during daytime, 3 times per week, for 12 weeks at Nanjing Maigaoqiao Community Health Service Center. Each exercise session contains 6 sections, each section lasts for 5 minutes, followed with a 1-minute rest period. The compression belt is deflated during the rest period. At least two trained research assistants supervise the exercise in each session. Instant heart rate during exercise is measured with heart rate monitor for each participant.
15739485|NCT04946799|Behavioral|High-intensity aerobic exercise (HI)|Participants (n=20) receives high intensity aerobic exercise intervention on a cycle ergometer (at 70% of heart rate reserve). Exercise is conducted during daytime, 3 times per week, for 12 weeks at Nanjing Maigaoqiao Community Health Service Center. Each exercise session contains 6 sections, each section lasts for 5 minutes, followed with a 1-minute rest period. At least two trained research assistants supervise the exercise in each session. Instant heart rate during exercise is measured with heart rate monitor for each participant.
15739486|NCT04946799|Behavioral|Low intensity exercise (LI)|Participants (n=20) receives low intensity exercise intervention on a cycle ergometer (at 40% of heart rate reserve). Exercise is conducted during daytime, 3 times per week, for 12 weeks at Nanjing Maigaoqiao Community Health Service Center. Each exercise session contains 6 sections, each section lasts for 5 minutes, followed with a 1-minute rest period. At least two trained research assistants supervise the exercise in each session. Instant heart rate during exercise is measured with heart rate monitor for each participant.
15739487|NCT04946786|Diagnostic Test|Laboratory investigations, pelvi-abdominal US, fibroscan, and in body analysis|"Complete history taking.
~Thorough clinical examination :Assessing for buffalo hump, double chin, acanthosis nigricans, skin tags or acrochordon and xanthelasma and anthropometric measurements as measuring height m, weight Kg, waist circumference (WC) Cm, hip circumference (HC) Cm.
~3. Pelvi-abdominal ultrasound. 4. Fibroscan examination will be done for all subjects to assess steatosis by measuring the CAP score.
~5. Body composition analysis: to detect water, muscle and fat percentage in the body.
~6. Laboratory investigations:All samples wil be analyzed for fasting blood glucose (FBG), and post-prandial (2hrs after meals) blood glucose, total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), very low-density lipoprotein (VLDL-C), alkaline phosphatase (ALK), aspartate transaminase (AST),alanine transaminase (ALT).
~• Fasting insulin levels will be measured using ELISA kits"
15739488|NCT04946760|Other|Sham Manipulation|The sham protocol will consist of examination of the subject's active and passive range of motion in the spine and extremities, in the joints that would have been treated with OMT. The subject will be positioned in sitting, supine and lateral recumbent in a similar manner to that of the OMT group, but without providing an active intervention.
15739489|NCT04946747|Device|Modern microelectrical mechanical systems (MEMS) head-impact sensors|Both groups will wear our smart head-impact sensor system (MEMS head-impact sensors) to measure their response to training.
15739490|NCT04946747|Other|Virtual Reality (VR) Goggle Use with consistent timing of Conditioned Stimulus and Unconditioned Stimulus|The Trained group will have the conditioned stimulus (CS, images of opposing players approaching) and the unconditioned stimulus (US, a voice cue to stiffen the neck by the coach) always being delivered with a consistent timing relationship (e.g. a 250 msec delay between the CS and the US), causing the conditioned response (neck stiffening) to emerge.
15739491|NCT04946747|Other|Virtual Reality (VR) Goggle Use with inconsistent timing of Conditioned Stimulus and Unconditioned Stimulus|The Control group will also receive the same CS and the same US as trained group, but the CS and the US will bear no consistent timing relationship, therefore never causing any CR to emerge.
15739492|NCT04946734|Device|PFO closure device|Device PFO closure.
15739493|NCT04946734|Drug|Aspirin and clopidogrel|Aspirin 100mg qd for 6 months and clopidogrel 75mg qd administered for 1month after device implanted.
15739494|NCT04946734|Drug|Triptans|If migraine recurred, Triptans would be administered during the acute phase.
15739496|NCT04946708|Other|Exercise program (virtual/remote)|Intervention (8 weeks): using the participants' initial assessment and personal characteristics, the therapist will provide personalized recommendations (e.g. maximum heart rate, minimum SpO2), explain the educational materials, and instruct patients on safety precautions. All participants (and immediate caregiver if necessary) will receive training in: 1) basic device management (join a zoom meeting, watch a YouTube video), 2) use of the portable spirometer and its associated app, 3) use of finger pulse oximeter and 4) recording of the values in a dairy.
15739497|NCT04946695|Other|Telefisio India|Implement telephysiotherapy programmes in low-resource areas.
15739498|NCT04946682|Diagnostic Test|Types of etiological diagnostic methods|In Group of mNGS, all patients will be tested by meta next generation sequncing on admission, while patients in Group of PCR will be tested by polymerase chain reaction in accordance with the method in the guidelines.
15739499|NCT04946669|Drug|Abatacept|Abatacept is a CTLA-4 fusion protein that inhibits T cell activation by competitively binding to CD80/CD86 and blocking the second signal. To date, Abatacept has been approved by the FDA for the treatment of three types of rheumatoid immune diseases (refractory rheumatoid arthritis, juvenile idiopathic arthritis, and active psoriatic arthritis). The international consensus of experts recommends abacepil as a second-line regimen for the treatment of refractory dermatomyositis based on the evidence of case reports. However, to date, there is no relevant report or clinical study registration information of Abatacept in the treatment of dermatomyositis.
15739501|NCT04946630|Device|PreciseInhale|Three different settings of the medical device PreciseInhale will be used in the study; PreciseInhale Whole Lung Exposure, PreciseInhale Bronchial Bolus/Breath hold Exposure and PreciseInhale Alveolar Bolus/Breath hold Exposure.
15739502|NCT04946630|Other|Seretide Evohaler forte|Single dose of Seretide Evohaler forte (fluticasone propionate/salmeterol 250 µg/25 µg) administered according to SmPc or via the PreciseInhale system.
15739503|NCT04946617|Drug|undefined|Rinsing with mouthwashes
15739504|NCT04946604|Behavioral|Ashtangayoga|This is an active and intense type of yoga, focused on physical activity and breath control
15739505|NCT04946578|Dietary Supplement|Prebiotic|6 weeks of prebiotic supplementation twice a day
15739506|NCT04946578|Other|Placebo|6 weeks of maltodextrin supplementation twice a day
15739507|NCT04946565|Diagnostic Test|Semen analysis|Semen analysis according to WHO laboratory manual for the examination and processing of human semen, Fifth edition
15739508|NCT04946552|Diagnostic Test|PET Scan|Participants will come to the PET Center to undergo the whole body [11C]MRB PET scan. An intravenous bolus dose of MRB (~20mCi) will be injected by an infusion pump. PET data will be acquired dynamically for 120 min using the Siemens mCT-X whole-body PET/CT scanner using continuous bed motion to image multiple PET bed acquisitions from the top of the head to the lower abdominal region.
15739509|NCT04946552|Dietary Supplement|Mixed Meal Test|High Carbohydrate Mixed Meal Test (MMT): participants will be studied after a 10-hour overnight fast. A nurse will insert an intravenous (IV) catheter and subjects will ingest a liquid meal (65% carbohydrate, 20% fat, and 15% protein, corresponding to 40% of daily energy expenditure, in ~16 ounces) to be prepared by the Hospital Research Unit Metabolic Kitchen. Blood samples will be collected at -10, 0, 15, 30, 60, 90, and 120 min) for measurement of glucose, insulin and C-peptide concentrations. Plasma samples will be drawn at baseline and throughout the MMT for measurement of additional hormones (such as thyroid hormones, and catecholamines) and free fatty acids (FFA) levels.
15739510|NCT04946552|Diagnostic Test|Muscle sympathetic nerve activity (MSNA)|Recording of multiunit postganglionic muscle sympathetic nerve activity (MSNA) will be made from the common peroneal nerve as it winds around the fibular head with the subject in the supine position with the subject's thigh comfortably supported. This procedure requires to first trace the course of the nerve using small electrical stimuli applied to the surface of the skin over the nerve or use of ultrasound to visually assist.
15739511|NCT04946552|Diagnostic Test|Oral Glucose Tolerance Test|Following a 10-hour overnight fast, a nurse will insert an intravenous (IV) catheter. Subsequently, subjects will ingest 7.5 oz of Glucola, which contains 75 g of dextrose in orange flavored water. Blood samples will be taken at -15, 0, 10, 20, 30, 60, 90 and 120 minutes (after glucola ingestion) for the measurement of plasma glucose, insulin, and C-peptide concentrations, and calculation of measurements of insulin sensitivity index (Matsuda Index). Approximately 40 mL of blood will be drawn at this visit.
15739512|NCT04946552|Other|Body Composition, Percent Body Fat & Percent Body Water (Tanita scale)|will be assessed using bioelectrical impedance analysis Tanita® scale; which is a special multi frequency segmental body composition analyzer that delivers a very mild electrical current that allows measurement of fat mass, percent body fat, fat free mass, total body water, and percent body water. This test will be performed at screening visit.
15739513|NCT04946552|Diagnostic Test|CT Scan|A CT scan will be performed for attenuation correction and to help delineate the BAT and other regions of interest (ROIs). Images will be reconstructed with an ordered subset expectation maximization algorithm using point spread function correction and time-of-flight information. To delineate fat (WAT, BAT) and skeletal muscle regions of interests (ROIs), CT images are first resliced to match the resolution and location of PET images. As performed in previous studies 2, a supraclavicular ROI is first manually drawn on the CT images. Within that area, the fat ROI is segmented using the CT images and an intensity window from -200 to -50 HU. Subsequently the fat ROI is segmented into WAT and BAT ROIs by using the 11C-MRB PET images: Standardized Uptake Value (SUV) ≥ 1.25 for BAT, SUV < 1.25 for WAT.
15739514|NCT04946552|Other|Body Composition, Percent Body Fat & Percent Body Water (DXA Scan)|For better accuracy, measurement of percent fat and percent body water will be obtained with whole body Dual X-Ray Absorptiometry (DXA) scan (Hologic®) on screening-OGTT visit. The scanner arm will move over the participant's body from feet to head. The machine uses a small amount of radiation (one tenth of the amount of radiation from a chest x-ray) to measure body fat, muscle and bone density.
15739515|NCT04946539|Diagnostic Test|Ultrasonography|Enthesitis assessment via ultrasonography
15739516|NCT04946526|Dietary Supplement|Broccoli seed extract|2 capsules, one dose
15739517|NCT04946526|Dietary Supplement|Broccoli seed extract with mustard seed powder|2 capsules, one dose
15739518|NCT04946513|Other|Muscle volumes were measured on pre- and postoperative MRI scans.|Muscle volumes were measured on pre- and postoperative MRI scans.
15739519|NCT04946487|Procedure|total laminectomy|Total laminectomy removes the posterior ligamentous complex (PLC) at the fusion and superior levels.
15739520|NCT04946474|Drug|Xingnaojing injection + Shuxuetong oral liquid|Xingnaojing injection (administered immediately after joining the group, once a day, treatment for 10 days) + Naoxueshu oral liquid treatment (administered on the 4th day of onset, 3 times a day, treatment for 30 days ).
15739521|NCT04946461|Drug|Dexamfetamine Sulfate 5 Mg Oral Tablet|The dosage is set based on the recommendation of the practitioner. Dexamphetamine is administered twice a day, with an interval of 4 hours.
15739522|NCT04946461|Drug|Lisdexamfetamine Dimesylate|The dosage is set based on the recommendation of the practitioner. Lisdexamphetamine is only administered once a day.
15739523|NCT04946461|Biological|blood samples|The blood samples will be taken at set times: 0, 2, 4, 6, 9 and 12 (hours)
15739524|NCT04946448|Other|FIT diet|Dietary intervention as add-on therapy to biologicals
15739525|NCT04946435|Combination Product|Antibiotic Irrigation|The first 30 patients will be assigned to the control group to collect data on common nasal packing colonization and appropriate antibiotic selection for the experimental group. The following 30 patients will be assigned to the experimental group. Immediately following surgery, the control group will receive nasal packing alone and the experimental group will receive nasal packing with antibiotic irrigation
15739526|NCT04946422|Procedure|Arthroscopy|Discharge diagnosis of patients with sports injury-related injuries
15739527|NCT04946409|Other|no intervention|no intervention
15739528|NCT04946396|Drug|dexmedetomidine intravenous infusion|Dexmedetomidine intravenous infusion during laparoscopic cholecystecthomy
15739529|NCT04946396|Drug|0.9%sodium chloride|0.9%sodium chloride intravenous infusion during laparoscopic cholecystecthomy
15739530|NCT04946383|Drug|Dasatinib plus Quercetin|Dasatinib plus Quercetin
15739531|NCT04946370|Drug|225Ac-J591|Alpha-emitter Actinium-225 conjugated to the anti-PSMA antibody J591.
15739532|NCT04946370|Drug|Pembrolizumab|Pembrolizumab will be administered intravenously, 400mg every 6 weeks. Patients may receive maximum 18 cycles of therapy, approximately 2 years.
15739533|NCT04946370|Drug|Androgen receptor pathway inhibitor|Patients will receive an oral androgen receptor pathway inhibitor (ARPI). Examples include enzalutamide and apalutamide. Dosing will be the standard dosing, as described by the package insert.
15739534|NCT04946370|Diagnostic Test|68Ga-PSMA-11|[185 ±74 MBq or 5 ±2 mCi] intravenous during screening and 12 weeks. Imaging agent for PSMA PET/CT.
15739535|NCT04946357|Radiation|Protons|proton irradiation with a total dose of 39 Gy(RBE) in 3 Gy(RBE) fractions
15739536|NCT04946357|Radiation|carbon ions|carbon ion irradiation with a total dose of 39 Gy(RBE) in 3 Gy(RBE) fractions
15739537|NCT04946344|Behavioral|Diet & Exercise|Participants will attend exercise and diet classes.
15739538|NCT04946344|Behavioral|Attention Control|Participants will attend healthy living classes and receive phone calls/emails/texts.
15739539|NCT04946331|Device|Electrical impedance tomography system|Which can use the applied current and measurement voltage through the body surface electrode group, and use the reconstruction algorithm to construct an image imaging system that exceeds the cross-sectional, which can provide images of the internal physiological changes of the chest contour, in order to quantify the changes in lung function caused by rib fractures.
15739542|NCT04946305|Other|Lutathera|Prospective observational study. There is no treatment allocation. Patients administered Lutathera by prescription that have started before inclusion of the patient into the study will be enrolled.
15739543|NCT04946292|Behavioral|Theory-derived intervention|The intervention will be delivered through multimedia materials and group activities, as appropriate. Participants will spend approximately 30-45 minutes for the intervention. Intervention materials and activities will be carefully designed to address all the constructs/ domains of the selected theoretical model(s). The effectiveness of the interventions will be evaluated using behavioural outcomes (diet, brushing, flossing) and clinical outcomes (oral hygiene, caries and periodontal conditions).
15739544|NCT04946292|Behavioral|Conventional health education|The conventional health education will be delivered through an oral health talk and oral health booklet. Topics covered are: (i) common oral diseases and its consequences; (ii) common dental problems among older adults; (iii) importance of oral health measures (healthy diet, toothbrushing and dental flossing); and (iv) proper techniques for toothbrushing and dental flossing.
15739545|NCT04946279|Other|Best Practice|Receive usual/standard of care
15739546|NCT04946279|Other|Informational Intervention|Receive conversation tool
15739547|NCT04946279|Other|Questionnaire Administration|Ancillary studies - Baseline and follow-up questionnaires
15739548|NCT04946266|Procedure|Surgical intervention|Surgical intervention with collection of tissue material
15739549|NCT04946253|Behavioral|DOCC: Evidence-based treatment for disruptive behavior and ADHD|Practices will learn and then deliver DOCC in treatment sessions with caregivers and/or children. The content covers key topics related to the treatment of behavior problems (e.g., self-management, positive parenting) and ADHD (e.g., psychoeducation, medication).
15739550|NCT04946253|Behavioral|TEAM: Implementation support strategies at the care team level following standard implementation of DOCC|Practices will learn and then deliver DOCC in treatment sessions with caregivers and/or children. Coaching and consultation will be provided to the provider care team to support the use of collaborative care for behavior problems and ADHD. The TEAM intervention includes regular virtual meetings or calls with the providers (about once/month, on average) that cover core chronic care model functions, including registry use, case-finding, collaborative care team roles, and workflows outlining how DOCC is delivered in the practice.
15739551|NCT04946253|Behavioral|Implementation support strategies at the leadership level following standard implementation of DOCC|Practices will learn and then deliver DOCC in treatment sessions with caregivers and/or children. Practice facilitation will be provided to practice leaders to help them support the care team's use of collaborative care for behavior problems and ADHD. The LEAD intervention includes regular virtual meetings or calls with practice leaders (about once/month, on average) that cover the assessment of practice capacity/barriers, ways to overcome organizational barriers and support staff use of DOCC, promoting innovation, and leveraging practice resources to support DOCC delivery and maintenance in the practice.
15739552|NCT04946240|Other|Supervised (BRACE) Group|Supervised (BRACE) protocol include static, dynamic and anticipatory balance exercises, chair rise, stair climbing and floor transfer comes under the category of resistance exercises. 6 minutes walk test, marching in space and cycling comes in aerobic. count reverse for 50 remember 5 words, 5 animals, repeat 5 words, spell forward and backwards and cont even numbers comes in cognitive exercises.
15739553|NCT04946240|Other|Conventional Balance Exercises Group|The home plan included Balance and Resistance exercises of BRACE protocol were provided to the control group but that was not supervised. Control group participants were also same assessed as the S-BRACE group. Before giving the training plan for home, it was elaborated in detail. For the convenience of participants, the BRACE protocol was also translated into Urdu and was given in the printed form. The data were collected at baseline, after 3 weeks, 6, 9 and then after 12 weeks of training
15739554|NCT04946227|Drug|Pembrolizumab 200mg +Paclitaxel 80mg/m2|Pembrolizumab 200mg +Paclitaxel 80mg/m2
15739555|NCT04946214|Behavioral|Smart Water Bottle|Patients will be given a smart water bottle and coached on its use. The device is a 24 oz non-bisphenol A acrylic water bottle with the ability to track water consumption from the bottle, alert its users via a smartphone-based notification system, as well as visually remind patients with a light-emitting diode in the device. Participants will be alerted to drink patient-specific volumes of room temperature water 45 minutes prior to daily standard of care radiotherapy.
15739556|NCT04946188|Device|Opuz NICGM|A wearable and non-invasive prototype device that allows for measurement of bioimpedance data with the aim to help develop a mathematical model to predict blood glucose levels.
15739557|NCT04946162|Drug|Tadalafil Pill|Each patient will be given tadalafil 40 mg one time
15739558|NCT04946136|Other|Gait modification|Individualized gait modifications guided by real-time visual feedback of knee load
15739559|NCT04946123|Dietary Supplement|L-carnitine+Selenium|Supplementation with L-carnitine and Selenium
15739664|NCT04945161|Other|Placebo|Placebo
15739561|NCT04946097|Other|gross Myofascial Release|Gross Myofascial Release : is amanual technique in form of Stretch of the Posterior Cervical Musculature and Gross stretch of gross Myofascial Release upper quarter: Arm Pull for duration of 10-15 min per session each stretch position was healed for 90sec
15739562|NCT04946097|Other|conventional selected exercise program|stretching exercises for cervical muscles and pectoralis major and source of heat in form of hot packs for 15 minutes
15739563|NCT04946097|Device|Transcutaneous electrical nerve stimulation (TENS)|Transcutaneous electrical nerve stimulation (TENS) is a method of pain relief involving the use of electrical current, the electrode placement on the course of pain for 15 minutes
15739564|NCT04946084|Procedure|Tympanocentesis|When acute otitis media is diagnosed, local anesthetic applied, small hole placed in eardrum, middle ear fluid extracted.
15739565|NCT04946084|Other|Nasal Phalangeal Swab and Wash|Nasal phalangeal swab used to retrieve sample. Nasal wash used to retrieve sample.
15739566|NCT04946084|Other|Blood Draw|Venipuncture
15739567|NCT04946071|Behavioral|Arts-based HIV stigma intervention|The intervention will consist of 2-hour weekly sessions offered to students in participating schools. HIV-related stigma will be addressed by providing key information related to HIV and stigma, facilitating the acquisition of coping skills, and utilizing local cultural practices facilitated by Elders using creative methods to shift existing social and cultural norms that produce and perpetuate stigmatization. Specific intervention activities will include three interrelated activities. The core 2-hour weekly session will cover (1) transformative educational activities; (2) arts-based activities; (3) a summative activity consisting of (3) participatory theatre events.
15739568|NCT04946058|Procedure|hyebrid Mathieu Urethroplasty|incision of the urethral plate during the procedure
15739569|NCT04946045|Other|Sensorimotor Interventions (Tactile/Kinesthetic Stimulation+Nonnutritive Sucking)|"Sensorimotor interventions were applied to in preterm infants between 30-33 weeks of age for 10 days. After that, preterms were included in the Six-phase feeding progression protocol."
15739570|NCT04946032|Other|Epidural catheter|The epidural catheter length will vary, either 4 cm or 5 cm into the epidural space.
15739571|NCT04946019|Combination Product|Unity-based MR-Linac guided FSRT|The FSRT was delivered using the Unity-based MR-Linac treatment machine, with a total dose of 30Gy in 5 fractions.
15739572|NCT04946006|Drug|Oxytocin|Oxytocin will be prepared in a 1L bag of Ringer's lactate, to be infused at a rate of 125 ml/h.
15739573|NCT04945993|Device|Endomethasone N|Endomethasone N is a powder intended to be mixed extemporaneously with a eugenol-based liquid (i.e, Endomethasone Liquid) to obtain a permanent root canal sealer. After selection of dentists, they will screen consecutively and systematically eligible patients, will send them the Patient Information Letter and will enroll them in the clinical investigation if non opposition from the patient. Patient clinical data will be recorded in an electronic Case Report Form. Pseudonymized retro-alveolar radiographies at baseline consultation and at 5 and 10 years post-obturation consultations will be recorded in the e-CRF. These radiographies will be examined by 2 independent endodontists and the results of these examinations will be recorded in the e-CRF. Site data will be collected on a Site Questionnaire with Visual Analog Scales.
15739574|NCT04945980|Dietary Supplement|Ground beef|Ground beef naturally low in monounsaturated fatty acids or naturally high in monounsaturated fatty acids
15739575|NCT04945967|Procedure|New Method|Physiological flexion in therapeutic positioning, oromotor stimulation (will be repeated 3 times for each regio), stimulation of synergistic movements, and stimulation for non-nutritive sucking by using special designed pacifier for premature infant.
15739576|NCT04945967|Procedure|Fucile Method|Oral stimulation and non-nutritive sucking stimulation using usual pacifier.
15739577|NCT04945954|Other|Drug: Cyclophosphamide|"Administer 14.5mg/kg of Cyclophosphamide once a day for 4days. (intravenously)
~Blood sampling of pharmacokinetics(PK) of cyclophosphamide will be performed in all patients who have taken the investigational drug for at least 4 days (For 2 days, It will be administered for pretreatment of transplant, for the other 2 days, It will be administered for Post-transplant treatment for the prevention of GVHD)"
15739578|NCT04945928|Procedure|Surgery|Participants having been evaluated as operable after receiving first-line treatment (first-line chemotherapy, targeted therapy, immunotherapy, chemotherapy combined with immunotherapy, etc.) will receive surgery.
15739579|NCT04945915|Other|blood sampling|There was no intervention because this reasearch is observational study.
15739580|NCT04945902|Behavioral|Synchronous Intervention|Weekly one-hour support groups. These support groups will meet virtually using a restricted WebEx channel and will be recorded. In this support group, students will discuss the weekly activities and build connection and support with each other. This group will be led by advanced doctoral students in counseling psychology and overseen by a counseling psychology faculty member, who is also a licensed psychologist.
15739581|NCT04945902|Behavioral|Asynchronous Intervention|The asynchronous intervention will provide access to information and resources for mental health support via Brightspace. The intervention will be six weeks long and each week will have a topic. The weekly topics include: (1) identifying feelings; (2) biology of emotions; (3) mindfulness; (4) recognizing and responding to stress; (5) mental health stigma; and (6) self-care/self-advocacy. Each week, you will be required to complete four types of activities: education, reflective exercises, an activity, and a short assessment. All of these resources will be provided on Brightspace to be completed on your own time but the activities must be completed during the week they are assigned. You will not have to interact with other international students if you are in the asynchronous intervention group.
15739582|NCT04945889|Diagnostic Test|Quick Sequential Organ Failure Assessment (qSOFA)|Clinical bedside tool that evaluates three vital parameters, scoring one point each if altered: respiratory rate (RR) ≥22 breaths/minute, systolic blood pressure (SBP) ≤100 mmHg and altered mental status (defined in our study as either Glasgow Coma Scale (GCS) score <15 or any worsening in the Italian Oriented, Disoriented, Agitated, Sleepy scale). A qSOFA score ≥2 points is considered indicative of sepsis.
15739583|NCT04945889|Diagnostic Test|Modified Early Warning Score (MEWS)|Clinical bedside tool that evaluates five vital parameters, with multiple scoring according to alteration: respiratory rate (0-3 points), heart rate (0-3 points), systolic blood pressure (0-3 points), body temperature (0-2 points), mental status (0-3 points, evaluated using the Alert, Verbal, Pain, Unresponsive - AVPU scale). A MEWS score ≥5 points is considered indicative of an acute condition at risk of sudden clinical deterioration.
15740749|NCT04936321|Behavioral|Internet-delivered Sleep Education|The program delivers publicly available information about sleep.
15739584|NCT04945889|Diagnostic Test|National Early Warning Score (NEWS)|Clinical bedside tool that evaluates seven parameters, with multiple scoring according to alteration: respiratory rate (0-3 points), oxygen saturation (0-3 points), need for any supplemental oxygen (0-2 points), body temperature (0-3 points), heart rate (0-3 points), systolic blood pressure (0-3 points), mental status (0-3 points, evaluated using the Alert, Verbal, Pain, Unresponsive - AVPU scale). A NEWS score ≥7 points is considered indicative of an acute condition at risk of sudden clinical deterioration.
15739585|NCT04945876|Behavioral|Digital follow-up|"Participants will receive:
~One session of individual exercise and diet guidance focusing on goals and motivation.
~An activity tracker and instructions on how to use it both for motivation, daily activity tracking, logging of specific exercise and using the wristbands heart rate monitor to control intensity level during exercise.
~Monthly digital follow-up to provide support and address questions and goals regarding nutrition, daily energy expenditure and exercise.
~Opportunity to send sms with questions regarding nutrition and exercise. Participants who are malnourished, or at risk of malnutrition will be offered a total of two hours of additional individualized, digital guidance on nutrition as needed."
15739586|NCT04945837|Other|self administered questionnaire|longitunidal descriptive study
15739587|NCT04945824|Drug|Dexamethasone Ophthalmic|Insertion Device: A handheld mechanical device used by the clinician to dilate the punctum and deliver the DEXTENZA insert into the canaliculus; designed to be single-use and pre-loaded with a single DEXTENZA insert.
15739588|NCT04945824|Device|Dilator|Intracanalicular Dilator Device
15739589|NCT04945811|Diagnostic Test|Interlukein 6 and procalcitonin serum levels|Blood tests
15739590|NCT04945798|Other|OMT|OMT: direct myofascial release, pedal pump
15739591|NCT04945785|Other|No intervention|no intervention
15739592|NCT04945772|Biological|Gene Therapy Product-vMCO-010|The vMCO-010 is an adeno-associated virus serotype 2-based vector carried multi-characteristic opsin (MCO) gene expression cassette
15739593|NCT04945772|Procedure|Sham Injection|Sham Injection
15739594|NCT04945759|Device|Isokinetick Exercise, Aussie Current, Russion Current, Plasebo Electirical Stimulasyon|Evaluation and treatment will be done with the Cybex humac device.
15739595|NCT04945746|Procedure|AF ablation|"AF ablation using the Volta Medical VX1 CE marked software and a new criteria to establish a priority of the dispersed zones according to the stability of the core algorithm's response (thanks to the new software module under study named stability)."
15739596|NCT04945733|Drug|Amivantamab|Amivantamab will be administered intravenously.
15739599|NCT04945707|Drug|Ferric Derisomaltose 1000 Mg in 100 mL INTRAVENOUS SOLUTION [Monoferric]|Ferric derisomaltose (Monoferric) 1000 mg X1 (for subject <50 kg, 20 mg/kg
15739600|NCT04945707|Drug|Placebo|Normal saline
15739601|NCT04945694|Other|Ultrasound-guided bilateral pecto-intercostal fascial block|- PATIENT IN SUPINE POSITION, SKIN WILL BE DISINFECTED, A HIGH-FREQUENCY LINEAR PROBE WILL BE PLACED PARALLEL TO LONGITUDINAL AXIS OF STERNUM ON LATERAL BORDER AND SCANNED LATERALLY TO IDENTIFY 4TH AND 5TH COSTAL CARTILAGE. THE PECTORALIS MAJOR MUSCLE (PMM), INTERNAL INTERCOSTAL MUSCLE (IIM), TRANSVERSUS THORACIS MUSCLE (TTM), RIBS, AND PLEURA WILL BE IDENTIFIED. COLOR DOPPLER ULTRASONOGRAPHY WILL BE USED TO DETERMINE PERFORATING BRANCHES OF INTERNAL THORACIC ARTERY, WHICH TRAVEL ANTERIORLY THROUGH THE ANTERIOR CHEST WALL, PIERCING THE INTERCOSTAL MUSCLE AND PMM. A 22G NEEDLE WILL BE INSERTED IN PLANE WITH PROBE, IN CAUDAL-TO-CRANIAL DIRECTION UNTIL THE TIP IS POSITIONED IN INTER- FASCIAL PLANE BETWEEN THE PMM AND IIM. NORMAL SALINE WILL BE USED TO DETERMINE CORRECT PLACEMENT OF NEEDLE TIP IN INTER-FASCIAL PLANE, AS SHOWN BY SEPARATION OF FASCIAL LAYERS THEN LOCAL ANESTHETIC WILL BE INJECTED
15739602|NCT04945694|Drug|Intravenous fentanyl|In this group, patients will receive only incremental doses of intravenous fentanyl
15739603|NCT04945694|Drug|Propofol|Propofol anesthesia
15739604|NCT04945694|Drug|Sevoflurane|Sevoflurane anesthesia
15739605|NCT04945694|Drug|Atracurium|Intravenous atracurium
15739606|NCT04945694|Device|ultrasound|ultrasound-guided block
15739607|NCT04945681|Biological|Pneumococcal conjugate vaccine|Mass campaign offering simultaneous pneumococcal conjugate vaccination to all children aged below 15 years of age living in Digaale camp, Somaliland. Children aged below 12 months receive 2 doses of vaccine, spaced 4 weeks apart. All other children receive one dose.
15739608|NCT04945668|Procedure|Modified technique for pericapsular nerve group block|with the patient in the supine position, ultrasound probe in a transverse plane over the anterior inferior iliac spine (AIIS) and then aligned with the pubic ramus. In this view, the ilio pubic eminence (IPE), the iliopsoas muscle and tendon will be observed. A spinal needle will be inserted from lateral to medial in an in-plane approach to place the tip between the psoas tendon and the pubic ramus. Fluoroscopic image will be taken to confirm the needle tip position in the target site. Following negative aspiration, 15 ml dye will be injected in 5-mL increments while observing for adequate spread using fluoroscopy followed by 15ml local anesthetic
15739609|NCT04945655|Other|Adolescents and parents' education and motivation at school (component 1)|"The component 1 includes first an information group session (duration: 1h30) on HPV infection and vaccination for parents. This session starts with a webconference delivered by two medical experts on HPV, using a standardized presentation. Then, a discussion is open for parents' questions and/or comments.
~Second, adolescents participate during the school time to two educational group sessions on HPV infections and vaccination, using a pedagogy based on active learning. These sessions (duration: 2h each) are delivered by the school staff (e.g., nurse, teacher in life sciences) using an educational package comprising: a guide that describes activities that should be implemented during each session; one video and a fact sheet developed by health students; a serious video game that promotes HPV vaccination and accessible on an internet website. Before the sessions, the school staff is encouraged to attend an e-learning training course (duration: 1 hour)."
15739665|NCT04945148|Drug|Metformin|Metformin 2000 to 3000mg/day daily will be started by 6 weeks after histological diagnosis and 7 days before the start of RT-TMZ and will continue until progression.
15740750|NCT04936308|Drug|Guselkumab|Participants will receive guselkumab as SC injection.
15739610|NCT04945655|Other|General practitioners' training (component 2)|The component 2 consists of an individual e-learning training session for general practitioners (GPs) that is accessible on computer and smartphone. Lasting 3 hours, GPs are able to access to the training whenever they want and then to progress at their own pace. The training includes three main parts: up-dated information on HPV infection and vaccination; an introduction to the use of motivational interviewing techniques in the field of vaccination; and a presentation of the decision aid tool developed as part of the intervention and explanation of how to use it during consultations. GPs may ask questions to the consortium team by using a dedicated chat.
15739611|NCT04945655|Other|Access to vaccination at school (component 3)|The component 3 aims at enhancing access to HPV vaccination for adolescents by offering them the first free-of-charge injection at school, without any medical prescription. For each concerned school, we organise a vaccination day inside the school premises where health professionals (one physician and one nurse) from the local vaccination centre initiate HPV vaccination with Gardasil-9® (in accordance with the French recommendations) for all eligible adolescents.
15739612|NCT04945642|Radiation|High-Dose Rate Brachytherapy|Undergo HDR-BT
15739613|NCT04945642|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15739614|NCT04945629|Drug|Alveolar ridge preservation with a PRP (PRGF-Endoret)|Filling of the alveolus with PRGF clot and fibrin plug.
15739615|NCT04945629|Drug|Blood clot and simple suture|Filling the alveolus with blood clot
15739616|NCT04945616|Drug|Aspirin、clopidogrel、placebo or SHR2285|groupA： Aspirin + clopidogrel + placebo or SHR2285 (dose 1) ；
15739617|NCT04945616|Drug|Aspirin、clopidogrel、placebo or SHR2285|groupB： Aspirin + clopidogrel + placebo or SHR2285 (dose 2)
15739618|NCT04945616|Drug|Aspirin、ticagrelor、placebo or SHR2285|groupC： Aspirin + ticagrelor + placebo or SHR2285
15739619|NCT04945603|Other|Standard management according to international/national guidelines|Standard management according to international/national guidelines. Observational study
15739620|NCT04945590|Behavioral|Virtual Intervention Program|Four separate virtual individual and group interviews (via telephone or online), which will be scheduled with the help of champions and leaders of the Latino community who will collaborate as companions to improve the commitment and experience of families.
15739621|NCT04945577|Diagnostic Test|Inflammatory Parameters|Laboratory measurement of patient's inflammatory status in unit of % and mg/dl
15739622|NCT04945577|Other|25 OH Vitamin D Level|Laboratory measurement of patient's 25 OH vitamin D level in unit of ng/dl
15739623|NCT04945564|Procedure|Oxygen therapy and physical therapy|Patients receive oxygen therapy and physical therapy
15739624|NCT04945564|Device|Oxygen therapy|Patients receive oxygen therapy
15739625|NCT04945551|Behavioral|Aerobic exercise training|12 weeks intervention period consisting of aerobic exercise training 3 sessions/week, 45 min/session. All training sessions are supervised. Aerobic training is conducted as ergometer bicycle training at an intensity of 70% of maximal oxygen uptake (x2/wk.) and rowing ergometer exercise at 70% of maximal heart rate (x1/wk.). In week 3, 6 and 9 VO2 max is measured to ensure sufficient adjustment of the workload during the training sessions.
15739626|NCT04945538|Other|Scatter radiation exposure measurement|Scatter radiation exposure of the operator and sterile assistant is recorded with digital live dosimeters at 3 locations of the operator (frontal head at eye level, left lateral head, below the left shoulder) and at 2 locations of the sterile assistant (left neck and below the left shoulder)
15739627|NCT04945525|Other|Care Continuity Program|The Care Continuity Program is an online patient self-assessment tool used by prescribers of opioids to better identify patient risk factors and opioid therapy benefit. This tool is completed by the patient, outside of the office, using an internet enabled device and follows a compliance driven protocol developed by analyzing case law against physicians in mis-prescribing opioid cases. Results, in the form of a date and time stamped legal report, are instantly transmitted to the prescriber's electronic health records, mitigating the prescriber's civil and criminal risk. A brief of findings is displayed within the software through a dashboard and on the summary page of the report. Prescribers may use the summary page to help them identify the appropriateness of initiating opioid therapy and/or continuing opioid therapy.
15739629|NCT04945499|Drug|d-glucose|using d-glucose as an contrast agent on CEST MR Imaging
15739630|NCT04945486|Other|Peer-mentor intervention|Peer-mentor support for up to 6 months
15739631|NCT04945473|Procedure|Endoscopic placement of additional sutures|A new endoscopic suture will be performed in case of a BMI≥30 or total weight loss (TBWL) less than 10%, and relaxation of gastric tubulization during the regular endoscopic follow-up after 6 months from the ESG. The same endoscopic suture technique of the primary ESG will be applied.
15739634|NCT04945447|Other|Systematic pharmacist intervention|Already described in the arm group intervention group for patient level
15739635|NCT04945434|Device|S53P4 bioactive glass (BonAlive)|Surgical implantation of S53P4 in a bone defect created during debridement for chronic osteomyelitis.
15739636|NCT04945421|Drug|Sintilimab|(IBI310 3 mg/kg IV d1, Q3W combined with sintilimab 100 mg IV d1, Q3W) or( IBI310 1 mg/kg IV d1, Q3W combined with sintilimab 200 mg IV d1, Q3W) for up to 4 cycles, and then sintilimab 200 mg IV d1, Q3W until progressive disease, intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.
15739637|NCT04945421|Drug|IBI310|(IBI310 3 mg/kg IV d1, Q3W combined with sintilimab 100 mg IV d1, Q3W) or( IBI310 1 mg/kg IV d1, Q3W combined with sintilimab 200 mg IV d1, Q3W) for up to 4 cycles, and then sintilimab 200 mg IV d1, Q3W until progressive disease, intolerable toxicity, start of a new antitumor treatment, withdrawal of informed consent, loss to follow-up, death or other situations requiring termination of treatment specified in the protocol, whichever occurs first.
15740751|NCT04936308|Drug|Placebo|Participants will receive matching placebo as SC injection.
15739638|NCT04945395|Device|FES and Conventional training|The experimental group will be fitted with the Functional electrical stimulation system L300 Go to be used during 4 weeks of inpatient rehabilitation in the subacute phase after hemiplegic stroke. Settings will be adjusted continuously to enhance dorsiflexion of the affected foot during walking and mobility training.
15739639|NCT04945395|Device|AFO and Conventional training|The control group will be fitted with an ankle-foot-orthosis (AFO) according to clinical practice to enhance dorsiflexion of the foot while taking part in conventional rehabilitation interventions during 4 weeks of inpatient rehabilitation including walking and mobility training in the subacute phase after hemiplegic stroke
15739640|NCT04945382|Device|Scotchbond Universal 3M|The occlusal surfaces will be cleaned using water, a brush and a low-pressure handpiece; they will wash and dry; then deproteinization will be done with sodium hypochlorite (5.25%) for 60 seconds, it will be washed with a water / air spray for 30s; it will dry up; The tooth will then be etched using a 37% orthophosphoric acid gel for 15 seconds, rinsed with a water / air spray for 30 seconds, and dried with cotton balls. Scotchbond universal 3M to the etched surface will be dried under a gentle air flow for 2-3 s, and light cured for 11 s using an LED curing unit with an output of 1500 mW / cm2 (Balloon.).
15739641|NCT04945382|Device|Single Bond 3M|The occlusal surfaces will be cleaned using water, a brush and a low-pressure handpiece; they will wash and dry; then deproteinization will be done with sodium hypochlorite (5.25%) for 60 seconds, it will be washed with a water / air spray for 30s; it will dry up; The tooth will then be etched using a 37% orthophosphoric acid gel for 15 seconds, rinsed with a water / air spray for 30 seconds, and dried with cotton balls. Single Bond 3M to the etched surface will be dried under a gentle air flow for 2-3 s, and light cured for 11 s using an LED curing unit with an output of 1500 mW / cm2 (Balloon.).
15739642|NCT04945369|Other|clinical and biological measurements and questionnaires|"Blood and urinary samples collection for evaluation of insulin resistance and of renal function analysis.
~Assessment of body composition by BOP-POD and by impedancemetry. Assessment of pulse wave by popmetre. Questionnaires for analysis of eating behaviour and of neuropsychological development."
15739643|NCT04945356|Other|upper limb training|The 6-week exercise program will consist of evidence-based exercises covering the breadth and depth of rehabilitation interventions. The therapist will choose the appropriate exercises for each participant's level of function from more than 15,000 exercises implemented within the Physiotec app and developed by rehabilitation experts. Personalized upper limb exercises will be based on the therapist initial assessment of participants, using the TERA+ telerehabilitation platform, and their goals. After each training session, participants will have to rate their perceived level of effort on a Borg scale (/10). The Borg scores will be monitored by the therapist as a precautionary measure to ensure safety and appropriateness of intensity of exercises. Participants will be instructed to train at a target score of around 7/10 (somewhat hard) on the Borg scale.
15739644|NCT04945343|Procedure|Growing Rods|Growing Rods(GR), are implants used to correct pediatric scoliosis deformity. They attempt to allow the growth of the spine and thorax while controlling curve progression to preserve normal lung volume.
15739646|NCT04945317|Other|ROSE (presence of cytotech)|Standard of care EBUS will include presence of trained cytotechnologist providing on-site cytopathology feedback to bronchoscopist during the procedure
15739647|NCT04945317|Other|NO-ROSE (absence of cytotech)|Standard of care EBUS will NOT include presence of trained cytotechnologist providing on-site cytopathology feedback to bronchoscopist during the procedure
15739648|NCT04945304|Procedure|magnetic bariatric surgery|Perform a roux-en-y gastric bypass, sleeve gastrectomy, nissen-sleeve or revisional bariatric procedure with magnetic assistance
15739649|NCT04945304|Procedure|Magnetic gastric bypass|Using the magnetic assistance to perform a gastric bypass
15739650|NCT04945291|Behavioral|New way of counting calories using the hands|The participants will learn how to estimate the portions and calories content of food using their hands as a measurement tool;
15739651|NCT04945291|Behavioral|Mobile applications|the participant will use a mobile application to log their calories
15739652|NCT04945278|Other|Double mirror device ALTER-EGO|"The patient and his matched healthy volunteer will be placed on each side of the double mirror device ALTER-EGO. Both sides will be lightened alternatively or at the same time by lights, so according to the light intensity, the subject will see himself in a mirror or the other person throw a classic window. The light intensity will vary from 0 to 100% and to 100% to 0% alternatively from each side of the mirror. At each 10% variation of one side, both patient and volunteer will have to answer that question : who do you see more : him/her or yourself ?"
15739653|NCT04945278|Other|EASE test|The patient will have to answer the EASE test which is a specific test to detect patient with high risk of psychosis or schizophrenia
15739654|NCT04945252|Diagnostic Test|Signpost caries|Identify carious lesion according to ICCMS visual criteria
15739655|NCT04945239|Behavioral|Amplification of Positivity Training (6 Sessions)|6 one-hour, clinician-administered treatment sessions focused on presenting rationale and instructions for completing positive activity exercises (e.g., gratitude, acts of kindness) designed to increase positive emotions, cognitions, and behaviors.
15739656|NCT04945239|Behavioral|Stress Management Training (6 Sessions)|6 one-hour, clinician-administered treatment sessions focused on presenting rationale and instructions for activity exercises designed to decrease stress.
15739657|NCT04945226|Drug|Finasteride 1mg Tablet|Propecia Tablet 1mg
15739658|NCT04945226|Drug|IVL3001|Finasteride long acting injection
15739661|NCT04945187|Other|Nurse-led consultations based on electronic patient-reported outcomes|The patients will weekly answer electronic patient-reported outcomes during chemotherapy and the answers will be used proactive in nurse-led consultations.
15739662|NCT04945174|Behavioral|Cardiorespiratory exercise combined with patient education and individual follow-up sessions|6 weeks of cardiorespiratory exercise combined with patient education at the hospital, followed by 6 weeks of cardiorespiratory exercise in the local municipality. Subsequently individual follow-up sessions with the aim to facilitate the patients to stay physically active in their everyday life
15739663|NCT04945161|Drug|ON101 Cream|Active ingredients: Extracts of Plectranthus amboinicus and Centella Asiatica
15739666|NCT04945148|Radiation|Radiation IMRT|2 Gy x 5 days for 6 weeks to be started 7 days after first administration of Metformin and by 7 weeks after histological diagnosis
15739667|NCT04945148|Drug|Temozolomide|75 mg/m² daily from first to last day of radiation (IMRT) and then 150 to 200 mg/m² x 5 days every 28 days cycle for 12 cycles
15739668|NCT04945122|Drug|Pitavastatin|Pitavastatin 4mg Qn
15739669|NCT04945122|Drug|Atorvastatin|Atorvastatin 20mg Qn
15739672|NCT04945096|Drug|decitabine|Decitabine (20mg/m2 intravenously from day -10 to day -8 of conditional regimen)
15739673|NCT04945096|Drug|Acetylcysteine|Acetylcysteine: 1.2g twice a day, oral administration, from day -10 to day 365 after HSCT.
15739674|NCT04945096|Drug|Semustine|Semustine: 250 mg/m2/day on day -9.
15739675|NCT04945096|Drug|Cytarabine|Cytarabine: 2 g/m2 every 12 hours on day -8.
15739676|NCT04945096|Drug|Busulfan|Busulfan: 3.2mg/kg/day on day -7 to -5.
15739677|NCT04945096|Drug|Cyclophosphamide|Cyclophosphamide: 1.8g/m2/day on day -4 to -3.
15739678|NCT04945096|Drug|Cyclosporin A|Cyclosporin A: 3mg/kg/d from day -8.
15739679|NCT04945096|Drug|Anti-thymocyte globulin|Anti-thymocyte globulin (2mg/kg/d on day -5 to day -2) will be added for transplants with unrelated donor or HLA mismatched donor.
15739680|NCT04945096|Drug|Mycophenolate|Mycophenolate (500mg, oral, twice a day from day -8) will be added for transplants with unrelated donor or HLA mismatched donor.
15739681|NCT04945083|Other|Experimental Nutritional Pudding|High Calorie, High Protein pudding
15739682|NCT04945070|Drug|IGlarLixi|Switching T2DM subjects from MDI to iGlarLixi
15739683|NCT04945070|Drug|MDI - Multiple dose insulin injection|Continuing with established MDI regimen
15739684|NCT04945057|Device|Mindpax monitoring system|All participants will use the Mindpax mobile application, wear the wrist accelerometer and fill in weekly self-assessments. All participants will obtain weekly health tips (general psychoeducation) and additional individualized targeted tips when the system detects deviation from individual mood, activity and sleep patterns
15739685|NCT04945044|Device|Computed adenoma detection system (CADe)|This is a computed system that helps the endoscopist to increase the detection of colorectal polyps
15739686|NCT04945044|Behavioral|Control group (regular colonoscopy)|It is exclusively the endoscopist in charge of the detection of the polyps (usual practice)
15739687|NCT04945031|Other|cannabis|This study is observational study, we recorded history of substance used, symptoms and medication in a medical chart.
15739688|NCT04945018|Biological|HS-001 CS|Human (allogeneic) iPS-cell-derived cardiomyocyte spheroids suspension
15739689|NCT04945018|Device|HS-001-D needle, HS-001-D Adaptor|Cardiomyocyte spheroids Dedicated Needles for Implantation and Guided Adaptors
15739690|NCT04945005|Procedure|Transesophageal guidance of lead implantation|In patients undergoing lead implantation including transesophageal echocardiography for clinical reasons (e.g. intraprocedural cardioversion), echocardiography was also used for guidance of lead implantation to reduce lead-leaflet interactions
15739693|NCT04944979|Biological|Kedrion IVIG 10%|Kedrion intravenous immunoglobulin (IVIg) 10%
15739694|NCT04944966|Drug|Maytenus Senegalensis|"Maytenus senegalensis (Malherbal) has a very long history of safe medicinal use in Africa in adult as well as infants and children. It will be administered orally at a dose of 800mg 8 hourly for 4 days.
~Artemether 20mg/lumefantrine 120mg"
15739695|NCT04944953|Drug|Botulinum Toxin Type A Injection [Botox]|Single administration, Day 0, 20 units
15739696|NCT04944953|Drug|Botulinum toxin type A injection [HG-102]|Single administration, Day 0, 20 units
15739697|NCT04944927|Other|Recording of clinical parameters and electrocardiogram parameters|Retrospective recording of demographic information (age, sex, age at diagnosis), genetic information, cardiological information, pharmacological treatments, electrocardiogram data. All above data will be deidentified.
15739698|NCT04944914|Drug|camrelizumab|Patients receive camrelizumab(200mg, iv drip for over 60min) every 2 weeks from 2 weeks before radiotherapy
15739699|NCT04944914|Radiation|stereotactic body radiotherapy|Patients receive stereotactic body radiotherapy for all oligometastatic lesions as radical therapy to control the disease and reduce any potential adverse impact to living quality. The dosage is based on published clinical studies.
15739700|NCT04944901|Drug|SB-121|SB-121 is a formulation of L. reuteri
15739701|NCT04944901|Drug|Placebo|Placebo oral formulation
15739704|NCT04944875|Procedure|Group headphone|The patients in the first group wore the headphones but did not listen the music or maternal voice. The standard sedation method was applied to all patients.
15739705|NCT04944875|Procedure|Group music|The patients in the second group listened to classical music (Vivaldi's The Four Seasons violin concertos) by sound- isolating headphones through the procedure.The standard sedation method was applied to all patients.
15739706|NCT04944875|Procedure|Group maternal voice|The patients in the third group listened to maternal voice by sound- isolating headphones through the procedure.The standard sedation method was applied to all patients.
15739709|NCT04944849|Diagnostic Test|Reaction Time Tests|While doing our research, the reaction time test in the Human Benchmark application, where the reaction time to many different stimuli on the computer can be evaluated, the Aim Trainer test and the auditory reaction time tests at https://playback.fm/audio-reaction-time will be applied.
15761919|NCT04761341|Drug|NUTROF TOTAL|1 per day over a course of 3 months
15739710|NCT04944836|Drug|Clomiphene Citrate|All patients will receive non-labeled pills identical in appearance from our pharmacy, to be taking once every other day. In the study group, these will contain 50 mg of clomiphene citrate. In the control group, these will be placebo. These will be taken every other day for seven months beginning four week prior to surgery and extending for six months after surgery. After enrollment patients will be randomized. Patient will be assigned to the 2 groups using a permuted block randomization scheme with blocks of size 2, 4, and 6. Prior to initiation of the study opaque sealed envelopes will be prepared and thoroughly shuffled and then used sequentially during the study. These randomization assignments will be available to the pharmacy in a web-based format or by cards in sealed envelopes. A nonparticipant in the study (the pharmacy at our institution) will administer this process.
15739711|NCT04944836|Procedure|Rotator Cuff Repair|The operative protocol will be standardized in all patients. Both the operative protocol and post-operative rehabilitation protocol will be per our standard of care, without alteration. An arthroscopic approach will be used. In all cases a double-row rotator cuff repair using triple-loaded anchor(s) on the medial row will be used. Post-operatively all patients will be placed in a sling for six weeks. Active range of motion exercises will begin at six weeks post-operatively and strengthening will be delayed until 12 weeks post-operatively. In all phases of care our peri-operative and post-operative protocol for study patients will be similar to our current clinical practice to ensure generalizability.
15739712|NCT04944823|Other|Clinical follow-up for 24 months|Sampling and clinical follow-up for 24 months
15739713|NCT04944810|Procedure|Magnetic Gastric Bypass|Perform a gastric bypass with the magnetic grasper to do the liver retraction, upper retraction of the stomach, upper retraction of the jejuno-jejunal anastomosis, upper retraction of the mesocolon to close petersen defect or the jejuno-jejunal anastomosis to close the intermesenteric defect also to do the retraction of the omega limb and perform the section of the limb and finish the gastric bypass
15739714|NCT04944810|Procedure|Magnetic Sleeve Gastrectomy|Perform a sleeve gastrectomy with the magnetic grasper performing the liver retraction and the upper retraction of the stomach
15739715|NCT04944810|Procedure|Revisional Bariatric Surgery|Perform liver retraction and also steps of the surgery like upper retraction of the stomach, upper retraction of the jejuno-jejunal anastomosis, upper retraction of the mesocolon to close petersen defect or the jejuno-jejunal anastomosis to close the intermesenteric defect also to do the retraction of the omega limb, upper retraction of the stomach
15739716|NCT04944810|Procedure|Nissen/Sleeve Gastrectomy with Magnetic Assistance|Perform a nissen-sleeve gastrectomy with the magnetic grasper performing the liver retraction and the upper retraction of the stomach, retraction of the stomach to close the hiatal defect and perform a nissen funduplication before do the sleeve gastrectomy
15739717|NCT04944810|Procedure|Mangetic General Surgery|Use the magnetic grasper to do the gallbladder retraction in cholecystectomies and upper retraction of the stomach to close the defect on hiatal hernia cases.
15739720|NCT04944771|Drug|Capivasertib|Participants will receive single oral dose of capivasertib on Day 1 for Treatments A, B and C.
15739721|NCT04944771|Drug|Rabeprazole|Participants will receive twice daily oral doses of rabeprazole for 3 days (Days -3 to -1) and a single dose on the morning of Day 1 for Treatment C.
15739722|NCT04944758|Device|Light therapy|Light therapy
15739723|NCT04944745|Other|Myofascial Release|Moderate pressure manual treatment to the pectoral fascia.
15739724|NCT04944745|Other|Soft-touch Control|No pressure manual treatment to the pectoral fascia.
15739725|NCT04944732|Diagnostic Test|laboratory examination, auxiliary examination, pathological results|Personal information (sex, age), medical history of present disease, past medical history, family history, symptoms and signs, supplementary examination items (including laboratory examination, impact examination)
15739726|NCT04944719|Diagnostic Test|nasopharyngeal aspirate|nasopharyngeal aspirate to determinate colonization by streptococcus pneumoniae
15739727|NCT04944706|Drug|Qishen Yiqi dripping pills 2 bags/time + Qishen Yiqi dripping pills placebo 2 bags/time|Take 3 times a day after meals,24 weeks
15739728|NCT04944706|Drug|Qishen Yiqi dripping pills 4 bags/time|Take 3 times a day after meals,24 weeks
15739729|NCT04944706|Drug|Qishen Yiqi dripping pills placebo 4 bags/time|Take 3 times a day after meals,24 weeks
15739730|NCT04944693|Other|Different ATS values.|"Observational, different ATS values were measured on MRI images and were regarded as interventions for different cohorts."
15739731|NCT04944680|Behavioral|Transcranial Direct Current Stimulation therapy|Transcranial Direct Current Stimulation with two saline-soaked electrodes (5cm x 7cm) is applied by our occupational therapist. The anode is placed on the ipsilesional primary motor cortex (C3/C4). The cathode is placed on the contralesional shoulder. The current is 1.5 milliampere and lasts 20 minutes.
15739732|NCT04944680|Behavioral|Motor imagery therapy|Stroke patients are asked to watch a video about the upper extremity movement. The video lasts 20 minutes. The contents are as follows: the patients are asked to relax the muscles for the first 2 minutes; the action refers to shoulder flexion and extension, elbow flexion and extension, forearm pronation and supination, wrist flexion and extension, finger flexion and extension, and corresponding daily functional activities for 16min; the patients are asked to relax their mind and body for the last 2 minutes.
15739733|NCT04944680|Behavioral|Transcranial Direct Current Stimulation and motor imagery therapy|The treatment parameters are the same as the above. It should be emphasized that the participants sit and perform the motor imagery task while receiving Transcranial Direct Current Stimulation.
15739734|NCT04944667|Diagnostic Test|TAVR planning|TAVR planning without VR vs after VR
15739735|NCT04944654|Drug|BIKTARVY 50Mg-200Mg-25Mg Tablet|Combination single tablet anti-retroviral therapy: bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg
15739736|NCT04944641|Behavioral|education on epilepsy|education on epilepsy, including epilepsy diary, pamphlet，discussion between patients and phone visits and so on
15739737|NCT04944641|Drug|routine and proper antiepileptic drugs|routine and proper antiepileptic drugs
15739738|NCT04944628|Dietary Supplement|Probiotic|Probiotic in liquid format (oil suspension) administered 10 drops once daily for 2 weeks (2x10^9 cfu/day)
15739796|NCT04944108|Procedure|LISA approach|Participants will be randomized to administer surfactant in a preterm manikin by using the LISA approach (thin catheter) or the INSURE approach (tracheal tube)
15739739|NCT04944615|Procedure|The guidewire successfully passed the CTO lesion|"The successful passage of the guide wire through the CTO lesion was defined as: the guide wire successfully passed through the CTO lesion and reached the distal true lumen as confirmed by angiography.
~Aspirin load dose (300 mg), clopidogrel load dose (300 mg), or ticagrelor load dose (180 mg) is recommended for all subjects prior to stent implantation and is recommended to be taken at least 6 hours prior to surgery."
15739740|NCT04944602|Biological|SYN008|injection of 300 mg
15739741|NCT04944602|Biological|Omalizumab for injection|injection of 300 mg
15739742|NCT04944589|Procedure|ROOT CANAL TREATMENT|Clinical endodontics involved in the goal of preventing and treating microbial contamination of pulps comprises of a number of treatments. Root canal endodontic therapy has one specific set of aims: to cure or prevent peri-radicular periodontitis, to conserve their natural teeth in function and aesthetics.
15739743|NCT04944576|Device|Total Ankle Prosthesis, EasyMove®|Patients who will be implanted with a total ankle prosthesis, EasyMove.
15739744|NCT04944563|Procedure|Segmentectomy|Patients receive segmentectomy
15739745|NCT04944563|Procedure|Lobectomy|Patients receive lobectomy
15739746|NCT04944537|Other|No Intervention|No Intervention
15739747|NCT04944524|Drug|Tofacitinib|"Tofacitinib 5mg twice a day for 12months;
~Basic treatment with prednisone. (1) the initial dose of prednisone (or equivalent): 0.8mg/kg/day. (2) Glucocorticoids tapering: after two weeks' usage of initial glucocorticoids dose, glucocorticoids can be tapered if there's no disease activity (BVAS/WG=0) or at least 50% reduction of BVAS/WG and no new manifestations. Prednisone (or equivalent) was reduced to 10mg/d at the time of randomization."
15739748|NCT04944524|Drug|Methotrexate|"Methotrexate (15 mg/week initially and progressively increased every week by 2.5 mg, to a maximum and optimal dose of 20 mg/week)
~Basic treatment with prednisone. (1) the initial dose of prednisone (or equivalent): 0.8mg/kg/day. (2) Glucocorticoids tapering: after two weeks' usage of initial glucocorticoids dose, glucocorticoids can be tapered if there's no disease activity (BVAS/WG=0) or at least 50% reduction of BVAS/WG and no new manifestations. Prednisone (or equivalent) was reduced to 10mg/d at the time of randomization."
15739749|NCT04944511|Drug|Toripalimab Injection|Toripalimab Injection used for mixed chimerism between 80%-95% in HLH patients. Dose: 240mg toripalimab Injection, two weeks later, the same dose will be repeated if patients have some improve in the chimeric rate.
15739750|NCT04944498|Procedure|Modified Tarsorrhaphy|A combination of levator recess, lateral tarsorrhaphy of 10 mm, and lateral canthopexy/lateral tarsal strip
15739751|NCT04944498|Procedure|Gold Weight Implant|Installation of 1,5 gram gold weight implant above tarsal plate and underneath levator recess
15739752|NCT04944485|Other|(FIT SA F03, SHOFU, USA)|Self adhesive giomer containing nanohybrid flowable composite
15739753|NCT04944485|Other|(Neo Spectra™ ST, Dentsply, Sirona, USA)|Conventional technique using putty nanohybrid resin composite
15739754|NCT04944472|Behavioral|HDKQ questionnaire|Studying the possibilities of perceiving information on the primary prevention of cardiovascular diseases in persons suffering from hypertension through the social network Instagram
15739755|NCT04944459|Device|Muse-S headband; InteraXon Inc., RRID:SCR_014418|"Muse-S is used as a technology-supported Mindfulness Training (tsMT) device as a way to introduce meditation as a method for managing chronic pain in individuals as it facilitates the learning process, requires minimal training to use and provides mechanisms to enhance compliance and track progress. The availability of direct feedback data from Muse-S may encourage the participant to perform meditation sessions and may increase time spent in the calm brain state."
15739756|NCT04944446|Other|Treatment|Myofascial release of various muscle groups Treatment of mobilization of the shoulder joint
15739757|NCT04944420|Behavioral|Health enSuite Caregivers|"Advice within Health enSuite Caregivers is organized into 5 priority areas: Taking Care of Yourself (Self-care), Support for You (Support), Supporting the Person Living with Dementia (Characteristics of Persons Living with Dementia), Communication, and Time Management.
~Under My Priority Areas, participants will see these in order from highest to lowest need, based on their answers to the needs assessment. Each priority area contains small subtopics and specific tips for things to Try or Avoid. Navigation through the priority areas is user directed and at the participant's discretion. The goal is to make the information they need easy to access."
15739758|NCT04944407|Procedure|LHP|A skin microincision of 3 mm was made about 1 to 1.5 cm of distance from the anal verge at the base of each hemorrhoidal node. The probe (1.85 mm of diameter) was driven through the incision in the submucosal tissue until reaching the area underneath the distal rectal mucosa. Then, ten to twelve effective pulses (adjusted to respective node dimensions), 8 watt per 3 seconds each, of approximately 24 Joule using a 1470-nm diode laser generator (LEONARDO® DUAL 45 Biolitec® Jena, Germany) were fired. Half of them were fired in the submucosal tissue, the others in the intra-nodal compartment determining the shrinkage of the hemorrhoidal piles. The anal wounds were left open. At the end of the procedure an anal tampon was positioned.
15739759|NCT04944407|Procedure|MM|The hemorrhoidectomy was performed by radiofrequency (LigaSure TM Small Jaw® Covidien®, Colorado, USA) or ultrasound (Focus® Ultracision® harmonic scalpel; Ethicon Endo-Surgery®, Inc., Cincinnati, Ohio). The anodermal wedge was incised, eventually removing external fibrosis and/or skin tags when present. Upward dissection started at this level with en-bloc excision of mucosal and submucosal layers from the underlying internal anal sphincter up to the anorectal ring. A compressive haemostatic sponge was left in place for 12-24 hours.
15739760|NCT04944394|Other|online questionnaire|"Administration of an online questionnaire (Limesurvey platform) at M0
~- This questionnaire includes a characterization of the professional (center, profession, usual department and department during the health crisis, family situation). Generic stress factors, the traumatic impact of the crisis and collective and individual coping strategies are also collected."
15739761|NCT04944394|Other|questionnaire survey|A questionnaire survey of the chief physician of the intensive care unit of each hospital will make it possible to characterize the support provided by the institution and how it changed over time
15739762|NCT04944381|Biological|SARS-Cov-2 mRNA vaccine immunization|The 98 participants will be inoculated with one dose SARS-Cov-2 mRNA vaccine from Stemirna Therapeutics Co., Ltd and .
15739763|NCT04944381|Biological|Inactivated SARS-Cov-2 vaccine immunization|The 14 participants will be inoculated with one dose inactivated SARS-Cov-2 vaccine from institute of medical biology, Chinese academy of medical sciences(IMBCAMS).
15740810|NCT04935801|Biological|LD vehicle-GNP|Two intradermal injections in the upper arm spaced 21 days apart
15739764|NCT04944368|Biological|SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant|SARS-CoV-2 recombinant spike protein (25 µg) with Advax-SM adjuvant (15 mg) in two doses with a 21-day interval administered with intramuscular injections in the non-dominant arm
15739765|NCT04944368|Biological|Saline placebo|0.9% sodium chloride (1 mL) injection in two doses with a 21-day interval administered with intramuscular injections in the non-dominant arm
15739766|NCT04944355|Other|ultrasound|diagnosis of morbid adherent placenta and incidence of urinary tract injuries during surgery
15739767|NCT04944342|Other|No intervention.|No intervention.
15739768|NCT04944329|Procedure|Hip fracture surgery|Hip fracture surgery
15739769|NCT04944316|Behavioral|Dietary intervention|Low-fat, plant-based diet
15739770|NCT04944316|Behavioral|Dietary intervention|Portion-controlled diet (compliant with ADA guidelines)
15739771|NCT04944303|Drug|Sugammadex|Sugammadex is a modified γ-cyclodextrin designed selectively to reverse the effects of the neuromuscular blocking agents (NMBAs) rocuronium and vecuronium
15739772|NCT04944303|Drug|Normal saline|Equal doseage of normal saline was injected to reverse the NMB.
15739773|NCT04944290|Drug|Brinzolamide/brimonidine ophthalmic suspension|Test product
15739774|NCT04944290|Drug|Simbrinza 0.2%/1% Ophthalmic Suspension|Reference product
15739775|NCT04944277|Other|ThoughtFullChat Application|A subscription-based mobile platform that empowers users to proactively engage with their mental health via self-serve tools and 1-on-1 daily bite-sized coaching with certified mental health professionals.
15739776|NCT04944264|Behavioral|Stress Management and Resiliency Training (SMART) program|The Stress Management and Resiliency Training (SMART) program (bensonhenryinstitute.org) is well validated comprehensive stress management program. It is designed to cultivate both the early recognition of stress in the mind and body, develop skills to mitigate stress and evoke the relaxation response and cultivate resiliency. It is an 8 session program, typically run in a live group setting. In this study's case it was delivered via a videoconferencing platform.
15739777|NCT04944251|Behavioral|Regular Exercise|the third month, for 30 minutes or 1 hour, 3 days a week
15739778|NCT04944238|Device|Ankoris|Implantations of test lens using standard phaco surgical technique, with aim for in-the-bag implantation.
15739779|NCT04944225|Other|Opiod Reduction Strategy|The intervention will involve a multi-faceted 3 component approach involving 1) opioid prescription caps (default maximum number of tablets for discharge prescriptions, as defined by evidence-based guidelines) 2) patient education tools (e.g. What is a normal pain trajectory? How to manage the pain? Benefits and potential harms of pharmacologic analgesia. Non-pharmacologic analgesia management? What to do if pain is excessive?), 3) provider education tools (e.g. including procedure-specific evidence-based recommendations for multi-modal analgesia; comparison of local baseline prescribing patterns with exemplary prescribing patterns; defining targeted reduction if baseline prescribing is at odds with best evidence; review of best evidence about optimal analgesia perioperatively), and 4) bi-weekly cumulative prescriber feedback on opioid prescribing patterns post-intervention and until end-of-study.
15739780|NCT04944212|Diagnostic Test|Measuring vitamin D serum level using ELIZA|Venous blood will be obtained from pregnant women at the time of admission and from the umbilical cord veins of the newborns immediately after their delivery. The quantitative measurement of 25OHD in serum will be performed using ELIZA.
15739781|NCT04944199|Other|Physical Activity|Intervention group participants will be enrolled in a standardized step-based program to gradually increase their physical activity. Daily steps will be measured via a pedometer application on a smartphone or wearable device, with a gradual increase in the goal on a weekly basis, with a target intervention of around 4-6 weeks in total. The first week's step count will be used to calculate a baseline step count for the week. At the start of each week, the participants will be asked to increase their daily step counts by 1,000.
15739782|NCT04944186|Procedure|Structured Pressure Injury Patient Education|It consists of PI education topics which include four main topics; 1) Pressure Injury: Why Me, which will be covering the basic information that patient need to know about PI; 2) Look After Your Skin, in this topics, patient will be thought about how skin checking was done and why it need to be done; 3) Preventing pressure injury, in this topic, patient will be emphasized on the suitable repositioning for them and the benefit of support surfaces and preventive wound dressing; 4) Help your PI heal, in this topic patient will be guided on what are condition that help PI healing and dietary needs to support wound healing
15739783|NCT04944186|Procedure|Standard Patient Education|No fixed content/ duration of patient education. Basically, patient repositioning emphasized verbally after wound dressing completed.
15739784|NCT04944173|Drug|Durvalumab|Subjects will receive durvalumab 1500mg IV every four weeks for four cycles, undergo assessment for residual disease, then a subset of subjects will receive an additional eight cycles of durvalumab.
15739785|NCT04944173|Radiation|Stereotactic Body Radiotherapy|Subjects will receive stereotactic radiation therapy concurrent with cycle 2 of durvalumab to a dose of 48Gy in four fractions. Fractionation may be modified for central tumors.
15739786|NCT04944173|Diagnostic Test|Circulating Tumor DNA assay|After four cycles of durvalumab, subjects will be evaluated at the MRD Landmark for residual ctDNA to determine subsequent treatment assignment.
15739787|NCT04944160|Other|Medical records analysis|To review of medical records to describe diagnosis and severity of the disease.
15739788|NCT04944160|Other|Comparison of cohorts|To compare pre and post Covid-19 epidemics in terms of numbers of admissions, and proportion of severe disease.
15739789|NCT04944147|Device|Anodal tDCS|Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (2 mA)
15739790|NCT04944147|Device|Sham tDCS|Sham transcranial direct current stimulation (tDCS), 9 sessions with 30 sec stimulation each (2 mA) to ensure blinding of participants
15739791|NCT04944147|Behavioral|Intensive cognitive training|Intensive cognitive training of a letter memory updating task, 9 sessions
15739792|NCT04944147|Behavioral|Progressive muscle relaxation (PMR)|Standardized instructed PMR training, 9 sessions
15739793|NCT04944134|Biological|COVID-19 Vaccination|Receipt of full COVID-19 vaccination
15739794|NCT04944121|Drug|RSLV-132|10 mg/kg RSLV-132 administered by intravenous infusion
15739795|NCT04944121|Drug|Sodium Chloride 0.9%|0.9% sodium chloride administered by intravenous infusion
15739797|NCT04944108|Procedure|Insure approach|Participants will be randomized to administer surfactant in a preterm manikin by using the INSURE approach (tracheal tube)
15739798|NCT04944095|Other|Change in SARS-CoV-2 Antibody Levels|Changes in plasma antibody levels over 12 months will be determine post-vaccination with one of the authorized SARS-CoV-2 vaccines.
15739799|NCT04944082|Drug|Ivermectin|(The same remdesivir dose as mentioned + ivermectin 4 tablet (6mg) once daily before meal for four days)
15739800|NCT04944069|Drug|Almonertinib|110 mg oral once daily
15739801|NCT04944069|Drug|Bevacizumab|15 mg/kg intravenous on Day 1 of 21 day cycles (every 3 weeks)
15739802|NCT04944056|Other|conventional physiotherapy|"Ultrasound therapy 3-4 minutes.
~Tibiofemoral AP and PA glides 1 set x10reps x 3 sets.
~Patellar glides 1 set x 5 reps x 3 sets.
~Quads isometrics 1 set x 10 reps.
~Hams self stretching 1 sets x 10 reps.
~Home plan:
~Quads isometrics 1 set x 10 reps.
~Hams self stretching 1 sets x 10 reps.
~Active range of motion."
15739803|NCT04944056|Other|compression mobilization|"Ultrasound therapy 3-4 minutes.
~Tibiofemoral AP and PA glides 1 set x10reps x 3 sets.
~Patellar glides 1 set x 5 reps x 3 sets.
~Quads isometrics 1 set x 10 reps.
~Hams self stretching 1 sets x 10 reps.
~Compression mobilization 1 set x 10 reps x 3sets.
~Home plan:
~Quads isometrics 1 set x 10 reps.
~Hams self stretching 1 sets x 10 reps.
~Active range of motion."
15739804|NCT04944043|Drug|TQ05105 Tablet|TQ05105 tablet is a JAK inhibitor, which can inhibit the abnormal activation of JAK2-V617F mutation, thereby inhibiting the sustained abnormal activation of JAK / STAT pathway.
15739805|NCT04944030|Procedure|Metastasis biopsy|Metastasis biopsy will be performed for multi-omic analysis Biological/Vaccine: Biomarkers blood, urine and microbiota samples Biomarkers blood, urine and microbiota samples for multi-omic analysis Behavioral: Patient Reported Outcome (PRO) Patient Reported Outcome (PRO) will be collected throughout the study duration to assess quality of life, anxiety, depression distress, physical activity and food habits.
15739806|NCT04944017|Drug|Ketamine Infusion|Participants will receive 6 infusions of ketamine (0.5 mg/kg IV, up to 60 mg total) , administered over 40 minutes while on continuous cardiac monitoring and oximetry
15739807|NCT04944017|Other|Placebo - Saline Infusion|Participants will receive 6 infusions of saline administered over 40 minutes while on continuous cardiac monitoring and oximetry
15739808|NCT04944004|Other|CogniPlus|The CBCT programmes proposed in this study is called CogniPlus. This software package offers training of scientifically proven trainable cognitive functions. According to the user manual, the lifelike interactive system and its automatic adaptability to client's ability level made CogniPlus feasible in community settings.
15739809|NCT04944004|Other|Training As Usual (TAU)|Training As Usual (TAU)
15739810|NCT04943991|Diagnostic Test|blood sampling (alpha-Galactosidase & LysoGb3)|"A blood sample will be taken. Alpha-Galactosidase level and LysoGb3 will be measured.
~Amendment: Offering of genetic testing for fabry specific GLA-gene"
15739811|NCT04943965|Diagnostic Test|Ultrasound imaging|"The intervention is non-invasive, chest wall, echocardiographic image acquisition in the cardiac operating room prior to a scheduled cardiac surgery. Echocardiographic images will be taken at three, key, timepoints in the operating room prior to cardiac surgery:
~Pre-induction.
~Post-induction / Pre-PAC
~Post-induction / Post-PAC"
15739812|NCT04943952|Drug|Asparaginase Erwinia Chrysanthemi (recombinant)|Participants will receive JZP458 via intramuscular injection.
15739815|NCT04943913|Biological|Tumor Infiltrating Lymphocytes (TIL)|Adoptive transfer of 1x10^9-3x10^11 autologous TILs to patients i.v. in 30-120 minutes.
15739816|NCT04943900|Drug|BMS-986416|Specified dose on specified days
15739817|NCT04943900|Drug|Nivolumab|Specified dose on specified days
15739818|NCT04943887|Behavioral|eSupport Health Weekly Group Sessions for PwMS|A formal semi-structured program of psychoeducational support delivered in an online weekly small group format by health coaches (licensed therapists) who specialize in MS.
15739819|NCT04943874|Device|Technology Based Intervention Group 1|Participants will be blinded to the two specific groups. They will not be aware of the technology used in the group they are not assigned too.
15739820|NCT04943874|Device|Technology Based Intervention Group 2|Participants will be blinded to the two specific groups. They will not be aware of the technology used in the group they are not assigned too.
15739823|NCT04943848|Biological|rHSC-DIPGVax|Off-the-shelf, neoantigen heat shock protein vaccine
15739824|NCT04943848|Drug|Balstilimab|BALSTILIMAB is a human monoclonal antibody that targets programmed cell death 1 (PD1)
15739825|NCT04943848|Drug|Zalifrelimab|ZALIFRELIMAB is a human monoclonal immunoglobulin G1k subclass (IgG1k) antibody that specifically recognizes cytotoxic T lymphocyte-associated protein 4 (CTLA-4, also known as CD152)
15739826|NCT04943835|Other|Observational - No intervention|
15739827|NCT04943822|Other|A new APP|A new APP for prevention and treatment of complications of intestinal peristomal skin
15739828|NCT04943809|Device|POD 26P AY FT|Routine cataract surgery
15739829|NCT04943809|Device|POD 26P AY F|Routine cataract surgery
15739830|NCT04943783|Drug|Atorvastatin 20mg|One with the intervention (Atorvastatin, 20mg OD), 20 patients for this arm.
15739831|NCT04943770|Procedure|Spinal cord stimulator implant|"Patients will undergo spinal cord implant procedures as per standard of care and be implanted with the WaveWriter™ Alpha Spinal Cord Stimulator (SCS) system.
~Implant Procedures will be followed by a healing period (4-6 weeks) during which patients will be offered therapy (up to one 1Khz). Patients will then be randomised to receive therapy at four different rates (A, B, C, D) in no particular order for 3-6 weeks each. Patients will then be followed up at 3 and 6 months after the last randomization visit."
15739832|NCT04943770|Diagnostic Test|Healing period|Acute opioid pain medications may be continued. No additional scheduled assessments will be completed during this period.
15739897|NCT04943237|Drug|Anti-TNF agents|Group of patients using anti-TNF for the last 5 years.
15740811|NCT04935801|Biological|LD PepGNP-Dengue|Two intradermal injections in the upper arm spaced 21 days apart
15739833|NCT04943770|Device|WaveWriter™ Alpha Spinal Cord Stimulator (SCS) system|Patients will then be randomised to receive therapy (up to 1KHz) at four different rates in no particular order for 3-6 weeks each. Patients will then be followed up at 3 and 6 months after the last randomization visit.
15739834|NCT04943757|Drug|Bendamustine Hydrochloride|50 mg/m2 iv Days +3 through +4 after allogeneic hematopoietic stem cell transplantation
15739835|NCT04943757|Drug|Cyclophosphamid|25 mg/kg iv Days +3 through +4 after allogeneic hematopoietic stem cell transplantation
15739836|NCT04943744|Device|Entero-tracker|Esophageal STRING test (Entero-tracker)
15739837|NCT04943731|Device|Provox Life|Phase 1: Like for like transition, Phase 2: Provox Life day/night regimen
15739838|NCT04943718|Biological|personalized vaccine|Based on genetic and transcriptional sequencing information, personalized peptide vaccines would be designed and produced; patients would be vaccinated on day 1, 4, 8 ,15, 22 and then on week 12, 20.
15739839|NCT04943705|Device|Yin and Yang Regulating Moxibustion|Before making Wenyang Yishen moxibustion, the width and length of the patient's moxibustion site were evaluated by the same body measurement method. Take about 700g of fresh ground ginger with moderate dryness and wetness, and place it on the treatment towel to make a round cake with a diameter of about 20cm and a thickness of about 2.5cm. Spread 25g of moxa moxa with a diameter of about 18cm on top of ginger and light it. When the bottom temperature reaches about 37 degrees, the door can be placed on the patient's waist for treatment. According to the patient's tolerance, the temperature should be controlled at 43-45 degrees. It is better to replace the moxa biscuit every time when the moxa biscuit is burned for about 10 minutes. The patient's local skin has a slight redness and burning. The moxibustion time is 60 minutes. Peiyuan Guben moxibustion is centered on Shenque, and the operation is the same as that of WenYang and Yishen moxibustion.
15739840|NCT04943692|Drug|Metformin glycinate|1050 mg, tablets Administered orally, twice a day, for 12 months.
15739841|NCT04943692|Drug|Metformin Hydrochloride|850 mg, tablets. Administered orally, twice a day, for 12 months.
15739842|NCT04943679|Drug|Anti-PD-1/PD-L1|Intravenous injection for up to 2 years
15739843|NCT04943679|Drug|PEG-Interferon Alfa|3 µg/kg every week by subcutaneous injection for up to 2 years
15739844|NCT04943666|Other|Hemorrhoid Disease Questionnaire|a new patient specific questionnaire (HDQ) with appropriate sensitivity and specificity to use for screening of patients with haemorrhoids in Russia in clinical practice for wider screening of haemorrhoids in population and for increasing patients' awareness of the disease and prompting them to seek professional advice.
15739845|NCT04943653|Drug|Paclitaxel|"intraperitoneal paclitaxel
~20mg/BSA(Body Surface Area), 40mg/BSA, 60mg/BSA (phase I)
~recommended dose (phase II)"
15739846|NCT04943640|Other|kinesio taping|Kinesio tape was developed by Kenzo Kase in the 1970s. It is an elastic tape, and its adhesive face is sinusoidal wavy. This feature has been shown to increase daily living activities and functions, as it supports the tissue while also allowing movement [12]. Kinesio tape lifts the skin and subcutaneous soft tissues of the fascia, which are painful and inflamed regions upon contractions seen in the tissue after tense adhesion to the skin. Therefore, it has been reported to reduce oedema and inflammation by creating more space and providing blood and lymphatic fluid flow.
15739847|NCT04943640|Other|rigid taping|The tape material used in rigid (athletic) tape application is hard. It is used to position and unite the soft tissue, to protect the tissue from impact and to prevent local swelling.There are studies in the literature supporting the sensorimotor and proprioceptive sensation-enhancing effect of the athletic band, which provides a very good sensory input through the skin.
15739848|NCT04943640|Other|placebo taping|Placebo taping was applied to the patients in this group, using betafix, an elastic fixation band, as the material. The patient was told that taping would be applied. A straight line betafix was applied to the non-painful scapular inferior level of the spine on the right and left sides of the standing patient.
15739849|NCT04943627|Drug|Balstilimab (BAL)|Anti-PD-1 Monoclonal antibody
15739850|NCT04943627|Drug|Topotecan|Chemotherapy
15739851|NCT04943627|Drug|Vinorelbine|Chemotherapy
15739852|NCT04943627|Drug|Gemcitabine|Chemotherapy
15739853|NCT04943627|Drug|Irinotecan|Chemotherapy
15739854|NCT04943627|Drug|Pemetrexed|Chemotherapy
15739855|NCT04943614|Other|Biodex balance system|BIODEX stability system (BIODEX Medical Systems Inc; Shirley, New York) offers a system that can deliver particular hip and ankle postural training strategy with external biofeedback as a monitor to enhance the reduced subclinical limitations of patients with diabetic neuropathy
15739856|NCT04943614|Other|conventional exercises|balance board exercises, walking on different surfaces, Wobble board exercise and parallel bars for ambulatory training, range of motion exercises, foot care as a home program. Same duration treatment
15739857|NCT04943601|Other|action observation therapy|The participants will be three meters from the screen onto which the videos will be projected. The initial posture will vary depending on each movement, lying down, sitting, or standing and ensuring a clear field of vision. The sessions will be performed in groups of three to four patients
15739858|NCT04943601|Other|conventional physical therapy|Verbal instructions will be given to perform and correct the movements requested. The sessions will be conducted in groups of three to four patients and all participants will have 3 to 4 assistants in the session, they will help them achieve their active-assisted range of motion requested in the exercises, when necessary.
15739859|NCT04943588|Diagnostic Test|HCV RNA (PCR)|We will test HCV positive patients after treatment to observe if they achieve SVR
15739860|NCT04943588|Diagnostic Test|HCV Antibody test (Point of care)|HCV antibody test used to establish if patients have had or are actively infected with HCV
15739861|NCT04943588|Diagnostic Test|AST/ALT and platelets measurement|AST/ALT and platelets to determine APRI score
15739862|NCT04943575|Dietary Supplement|EZC Pak|After the onset of common cold symptoms, participants will take one pill (EZC Pak) each day for a period of 5 days.
15739863|NCT04943575|Dietary Supplement|EZC Pak +D|After the onset of common cold symptoms, participants will take one pill (EZC Pak +D) each day for a period of 5 days.
15739864|NCT04943575|Dietary Supplement|Placebo|After the onset of common cold symptoms, participants will take one pill (Placebo) each day for a period of 5 days.
15739865|NCT04943562|Diagnostic Test|ACT+EEG|Combination of ACT+EEG. This is not an intervention, but rather a combination of devices to be tested regarding its diagnostic validity.
15740872|NCT04935320|Drug|HTL0016878.Citrate Capsule 10 mg|Oral capsule fed or fasted
15739866|NCT04943549|Drug|Bupivacain|Patients will be placed in left lateral position. A low-frequency curved array ultrasound transducer will be used. The ultrasound transducer will be placed in a longitudinal orientation 2-3 cm lateral to the midline to identify the hyperechoic line of the transverse process. After identification of muscles superficial to the transverse process and local infiltration of anesthesia into the superficial tissues, a block needle will be inserted in a craniocaudal direction until contact will be achieved with the transverse process where the tip will lay in the interfascial plane below the erector spinae muscle. A small bolus of local anaesthetic should be given through the block needle; the erector spinae muscle should be visualized, separating from the transverse process. A total of 20 mL bupivacaine 0.25% will be injected into the interfacial plane deep to the erector spinae muscle bilaterally. Forty minutes after the ESPB, the cutaneous sensory block will be assessed.
15739867|NCT04943536|Drug|bicalutamide|localized anti-androgen therapy
15739868|NCT04943536|Radiation|Stereotactic body radiation therapy|localized radiation therapy
15739869|NCT04943523|Dietary Supplement|Krill Oil|Krill oil supplements 4g/day
15739870|NCT04943523|Dietary Supplement|Vegetable Oil|vegetable oil supplements 4g/day
15739871|NCT04943510|Other|Physical exercices|"surface EMG: surface electrodes will be positioned on the muscles to evaluate the level of muscle activation
~non invasive muscular neurostimulations : application of a percutaneous electrical stimulation of the motor nerve of the considered muscle and a direct electrical stimulation of the muscle"
15739872|NCT04943497|Other|ribociclib|There is no treatment allocation. Patients administered ribociclib by prescription that have started before inclusion of the patient into the study will be enrolled.
15739873|NCT04943497|Other|aplelicib|There is no treatment allocation. Patients administered aplelicib by prescription that have started before inclusion of the patient into the study will be enrolled.
15739874|NCT04943497|Other|mono endocrine therapy|There is no treatment allocation. Patients administered mono endocrine therapy by prescription that have started before inclusion of the patient into the study will be enrolled.
15739875|NCT04943497|Other|chemotherapy|There is no treatment allocation. Patients administered chemotherapy by prescription that have started before inclusion of the patient into the study will be enrolled.
15739876|NCT04943484|Procedure|imaging fluorescence NIR/ICG|"Preoperative upper GI endoscopy (UGE) UGE with submucosal injection of 2ml of ICG 0.125mg/ml solution to four peritumoral sites 15-20 hours before surgery Surgery D2 Distal gastrectomy with dissection of 1, 3, 4sb, 4sd, 5, 6, 7, 8a, 9, 11p, 12a lymph node stations (LNS) D2 Total gastrectomy with dissection of 1, 2, 3, 4sa, 4sb, 4d, 5, 6, 7, 8a, 9, 11p, 11d, 12a LNS Intraoperative NIR/ICG technology, change of surgical conduct (CSC) A visualization of the operative field (OF) with NIR/ICG technology is performed at the beginning of surgery and before to dissect each LNS. Subsequently, surgery is performed with the naked eye.
~At the end, a visualization of the OF is performed using NIR/ICG technology to verify whether residual lymph nodes in each D2 nodal station exist. CSC is defined as the occurring of the following situation: in case of persistence of nodal fluorescence in D2 nodal stations, the completion of the dissection of the residual nodal fluorescent structures."
15739877|NCT04943471|Other|Big Five Questionnaire, Patient health questionnaire-9 and generalised anxiety disorder -7 questionnaire|Questionnaire
15739878|NCT04943458|Other|Monitoring of cerebral autoregulation|Patients will be monitored for cerebral autoregulation using a Vittamed 505 monitor to identify the dynamics of the autoregulation index VRx (t). Intracranial pressure (ICP) will also be measured by non-invasive ultrasound using a robotic TCD device, Dolphin4D (Israel), which simultaneously records MCA blood flow in both hemispheres of the brain. APAs will be assessed using mathematical models.
15739882|NCT04943432|Behavioral|Behavioral Activation|8 sessions of harm reduction-focused Behavioral Activation for Substance Use
15739883|NCT04943419|Diagnostic Test|Level of Myeloid-Derived Suppressor Cells|Establishing of levels of all MDSC, PMNMDSC, MMDSC, EMDSC, M/PMN MDSC ratio on the day before operation.
15739884|NCT04943393|Other|nointervention|Nointervention
15739885|NCT04943380|Diagnostic Test|Cxbladder|The Cxbladder Detect test, developed by Pacific Edge Ltd (O'Sullivan 2012; Holyoake 2008; National Health Committee 2015b) is a molecular diagnostic test, which consists of five mRNA transcripts measured in a small volume of urine.
15739886|NCT04943367|Device|TEAS|Transcutaneous electrical acupuncture stimulation
15739887|NCT04943354|Behavioral|Taking a person's venous blood|Collection of 5 ml of the patient's venous blood, carried out according to standard rules.
15739889|NCT04943328|Device|Total Hip Arthroplasty|cemented hip arthroplasty
15739890|NCT04943315|Procedure|Monolithic zirconia|posterior crowns
15739891|NCT04943315|Procedure|Metal-ceramic|posterior crowns
15739892|NCT04943302|Drug|Bendamustine Hydrochloride|To be given by IV at 70mg/m2 on cycle days 1 and 8 for up to 6 cycles
15739893|NCT04943302|Drug|Isatuximab|To be given by IV at10mg/kg IV on cycle 1 days 1,8,15, and 22; cycle 2-6 days 1,8; and cycle 7-12 days 1
15739895|NCT04943276|Device|Embr Device|The Embr thermal device will be worn at all times from study start to the study endpoint.
15739896|NCT04943263|Other|Tracheal Temperature|Temperature measured from the endotracheal tube compared with the esophageal temperature
15739898|NCT04943237|Drug|Conventional therapy users for the last 5 years|Group of patients not using anti-TNF. Group of patients using conventional therapy (non -steroid anti-inflammatory drugs and/or salazopyrin) for the last 5 years
15739899|NCT04943224|Drug|Trametinib|< 6 lat 0,032mg/kg, ≥ 6 lat 0,025mg/kg,
15739900|NCT04943211|Drug|fluorodeoxyglucose (18F-FDG)|max 6 MGBq/kg, no more than 100
15739901|NCT04943198|Drug|Vemurafenib|20 mg/kg/day
15739902|NCT04943185|Device|XEN gel microstent implantation|"Two differents implantation :
~Ab interno : Operative intervention Ab externo : Slit lamp intervention"
15739905|NCT04943146|Drug|Prednisone 10 MG+aspirin 100MG|Discontinue medication based on early pregnancy outcome
15739906|NCT04943133|Device|Blood pressure measurement and collection of the oscillometric curve for later SFATI analysis|Brachial systolic arterial blood pressure will be systematically taken with acquisition of the oscillometric curve for analysis and measurement with the SFATI system and simultaneous electronic recording of the Korotkoff sound (auscultatory method) and a search for SFATI arterial stiffness markers for all patients. Brachial systolic arterial blood pressure will be measured with the help of a cuff equipped with a Biopac SS30L electronic stethoscope and a MA-300 phonocardiographic microphone, placed side-by-side immediately downstream from the brachial occlusion cuff. The various signals (pneumatic cuff, oscillometric signal and Korotkoff sounds) will be digitalized by an MP35 system.
15739907|NCT04943133|Device|Blood pressure measurement with the usual equipment used in the department|Brachial systolic blood pressure will be taken via the conventional oscillometric method, only for hospitalized women. Blood pressure will be measured on the same arm with the help of a conventional Dinamap-type automat (GE), with at least 2 minutes between the end of the first measurement and the start of the second inflation.
15739908|NCT04943133|Device|systematic measurement of pulse wave velocity (aortic and brachial)|"Carotid to femoral and carotid to radial pulse wave velocity (Complior) will be systematically determined for hospitalized women and offered to all women seen for consultation.
~Pulse wave velocity will be measured with the help of a Complior tonometric system (Alam Medical, Vincennes, France), with which the aorta and the arterial axes of the upper limb used to measure blood pressure can also be measured."
15739909|NCT04943120|Procedure|"Snow-plow technique"|In class II cavities, application of X-tra Base bulk fill flowable composite (VOCO) in 1 mm thickness without curing followed by X-tra Fill bulk fill packable composite (VOCO) to restore the proximal wall. Polymerization as one unit for 20 seconds.
15739910|NCT04943120|Procedure|Bulk fill technique|In class II cavities, application of 4 mm increment of X-tra Fill bulk fill packable composite (VOCO) to restore the proximal wall. then the restoration id fully polymerized.
15739911|NCT04943107|Other|no intervention|no intervention, only measurement of blood pressure, intraocular pressure, hypertensive history questionnaire, retinal imaging, optical coherence tomography examination etc..
15739912|NCT04943094|Other|Urodynamic examination|A urodynamic examination is performed in all patients four to six weeks following TURBT and repeated six months later in order to obtain bladder function and possible changes.
15739913|NCT04943081|Procedure|Percutaneous nephrolithotomy|Percutaneous nephrolithotomy (PCNL) is a technique used to remove complex renal stones, or stones resistant to shockwave lithotripsy. A tube is placed through the incision in the kidney, under X-ray guidance, and renal stones are extracted by using nephroscope
15739914|NCT04943068|Drug|Bremelanotide|Subjects will self-administer a fixed dose (1.75 mg) of bremelanotide (BMT) subcutaneously (SC) via auto-injector.
15739915|NCT04943068|Drug|Placebo|Subjects will self-administer a Placebo subcutaneously (SC) via auto-injector.
15739916|NCT04943055|Procedure|Low temperature plasma lacrimal duct obstruction ablation combined with lacrimal duct catheterization|The operation used a tear point dilator to expand the patient's upper and lower tear points, YAG laser/low-temperature plasma knife was used to clear the obstructed site of the patient, and normal saline was used to rinse to ensure the patency of the lacrimal passage. The silicone lacrimal duct drainage tube was selected to put the lacrimal duct drainage tube in the upper and lower lacrimal dots of the patient, and the metal probe was removed after using a crochet, and the drainage tube was moderately pulled upward from the center of the upper and lower lacrimal dots to facilitate the smooth passage of the drainage tube through the whole lacrimal duct and achieve the purpose of dredging the blocked site again. Adjust the length of the drainage tube in the nasal vestibule and leave it in the nasal cavity.
15739917|NCT04943055|Procedure|YAG lacrimal duct laser combined with lacrimal duct catheter|The operation used a tear point dilator to expand the patient's upper and lower tear points, YAG laser/low-temperature plasma knife was used to clear the obstructed site of the patient, and normal saline was used to rinse to ensure the patency of the lacrimal passage. The silicone lacrimal duct drainage tube was selected to put the lacrimal duct drainage tube in the upper and lower lacrimal dots of the patient, and the metal probe was removed after using a crochet, and the drainage tube was moderately pulled upward from the center of the upper and lower lacrimal dots to facilitate the smooth passage of the drainage tube through the whole lacrimal duct and achieve the purpose of dredging the blocked site again. Adjust the length of the drainage tube in the nasal vestibule and leave it in the nasal cavity.
15739918|NCT04943042|Drug|Avatrombopag|According to prescription
15739919|NCT04943029|Drug|Carrelizumab|Camrelizumab: 200mg, IV, day 1 of each 21-day cycle, neoadjuvant therapy : 3 cycles; Adjuvant therapy: 16cycles.
15739920|NCT04943029|Drug|Pemetrexed (Nonsquamous NSCLC) or Nab-paclitaxel(Squamous NSCLC)|Nab-paclitaxel: 260mg/m^2, IV, day 1 of each 21-day cycle, 3 cycles; Pemetrexed: 500 mg/m^2, IV, day 1 of each 21-day cycle, 3 cycles.
15739921|NCT04943029|Drug|Carboplatin|Carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 5 i.v. on day 1 of each 21-day cycle for 3 cycles.
15739922|NCT04943029|Procedure|Surgery|Surgery must be done within the 4th-6th week from day 1 cycle 3 of neoadjuvant treatment (4-6 weeks after day 1 of cycle 3)
15739972|NCT04942626|Drug|Capecitabine|Capecitabine will be administered using a 3+3 dose escalation design (500 mg/m2 bid, 650 mg/m2 bid and 825 mg/m2 bid po, respectively) from day 1 to day 40 of RT including weekends.
15740812|NCT04935801|Biological|HD vehicle-GNP|Two intradermal injections in the upper arm spaced 21 days apart
15739923|NCT04943016|Drug|CD19 Chimeric Antigen Receptor (CAR) T Cells|This study seeks to examine the feasibility and safety of the administration of autologous T cells that have been modified through the introduction of a chimeric antigen receptor targeting the B cell surface antigen CD19 following administration of chemotherapy lymphodepletion regimen in children and adults with relapsed/refractory B cell malignancies. The overall goal of this study is to validate the safety profile of administration CD19 CAR T cells and describe the toxicities in children and adults with relapsed/ refractory B cell malignancies. Each patient implements leukapheresis 2 weeks after enrollment and infuse CD19 CAR-T cell around 2 weeks after leukapheresis, and administrated chemotherapy lymphodepletion regimen 1 week before infusion. Furthermore, the treated subject would be following up around 2 years.
15739924|NCT04943003|Device|Transcranial Direct Current Stimulation (tDCS)|"Initially, a measuring tape will be used to make the markings and measurements necessary for placing the electrodes.
~Regarding neurostimulation, the tDCS device is simple and portable, consisting of four main components: two electrodes (anode and cathode), an ammeter (electric current intensity meter), a potentiometer (voltage controller between electrodes) and a set of batteries. We will use the TCT-Research Neurostimulator, developed by Trans Cranial Technologies (Hong Kong, China), Regarding the protocols, the Active tDCS group will receive active tDCS for 30 minutes and for 5 consecutive days, in two weeks, with an anode positioned on the left DLPFC and a cathode electrode placed on the right supraorbital area. The 10-20 International EEG system will be taken as a reference. The current intensity will be defined from computational modeling, using Nuclear Magnetic Resonance (NMR) to estimate and individualize the dose to be administered."
15739925|NCT04942990|Other|calisthenic exercises|these exercises are a kind of exercise for increasing cardiovascular endurance
15739926|NCT04942977|Device|telemonitoring|"The system consists of the following elements:
~Professional website at the hospital, which allows:
~To set up an individualised care plan
~To establish the patient's risk profile and targets for improvement.
~Long-term monitoring of the evolution of cardiovascular risk factors and events that occurred
~Advise the patient on self-management strategies.
~Mobile application software with the following functions:
~Scheduled exercise sessions
~Medication reminder
~Measurement reminder (weight, blood pressure, heart rate, waist circumference, etc.)
~Messages: Inbox folder for system messages and messages generated by professionals for a specific patient or video conference.
~Training monitor: guides the patient in the performance of their exercise.
~Access to certified health information for patients"
15739927|NCT04942977|Other|Centre-based cardiac rehabilitation|The physical activity consisted of a workout routine and aerobic cycling training. Patients are instructed to perform 150 minutes per week of moderate physical activity when the hospital phase finishes.
15739928|NCT04942964|Drug|Bocidelpar|Oral
15739929|NCT04942951|Diagnostic Test|Gynecological examination|Gynecological examination was performed to the whole pregnant cohort included in the study to diagnose either the pelvic organ prolapse according to the POP-Q system or to be sure that they have no findings of pelvic organ prolapse.
15739930|NCT04942951|Other|Pelvic Organ Prolapse Quantification (POP-Q)|Gynecological examination was performed to the whole pregnant cohort included in the study to diagnose either the pelvic organ prolapse according to the POP-Q system or to be sure that they have no findings of pelvic organ prolapse.
15739931|NCT04942951|Other|Incontinence Consultation Questionnaire-Short Form (ICIQ-SF) questionnaire|ICIQ-SF questionnaire was applied to the Study group to determine the severity of urinary incontinence.
15739932|NCT04942951|Other|Pregnancy-Related Anxiety Questionnaire-Revised 2 (PRAQ-R2) questionnaire|PRAQ-R2 questionnaire was applied to the whole pregnant cohort included in the study to determine their anxiety status.
15739933|NCT04942938|Device|NeuBie|The NeuBie is a direct current neuromuscular electrical stimulation device. This system uses an exponential wave pattern to mimic the natural pattern neurologically to lengthen fibers of the sarcomere and engage force velocity of muscle with minimized protective co-contraction of nearby muscle groups. The golgi tendon and muscle spindles code for joint position and muscle/tendon stretch with 66% of fibers being intrafusal. Impacting these structures has direct impact on reticulospinal tract fibers and proprioceptive central fibers modulation of levels of spasticity. The NeuBie direct current is designed to improve positioning of these stretch receptors.
15739934|NCT04942925|Device|Verofilcon A contact lenses|Commercially available silicone hydrogel contact lenses for daily disposable wear
15739935|NCT04942925|Device|Kalifilcon A contact lenses|Commercially available silicone hydrogel contact lenses for daily disposable wear
15739936|NCT04942899|Drug|letrozole|concurrent capecitabine 500 mg three times daily in combination with letrozole 2.5 mg orally once daily.
15739937|NCT04942886|Drug|Entecavir|The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after hematopoietic stem cell transplantation.
15739938|NCT04942873|Other|adherence|PDC value and MMAS-8 scale were used to evaluate the compliance of patients with dabigatran, rivaroxaban and wafarin
15739939|NCT04942860|Drug|1% Methotrexate gel|1% methotrexate gel applied onto a predefined limb
15739940|NCT04942860|Drug|0.5% Methotrexate gel|0.5% methotrexate gel applied onto a predefined limb
15739941|NCT04942847|Device|Sucking trainer|Repeated sucking for tongue flexibility training can improve the tongue muscle's ability to control and transmit food, and improve the swallowing function.
15739942|NCT04942847|Device|Cognitive card|To measure the patient's ability to focus, to calculate, to remember and to judge
15739943|NCT04942834|Drug|Antiarrhythmic drug including Propafenone, Sotalol, Dronedarone and Amiodarone|Class I or III antiarrhythmic drug, including sotalol
15739944|NCT04942834|Device|cryoballoon ablation|Pulmonary vein isolation by cryoballoon ablation using Medtronic Arctic Front Advance™ Cardiac CryoAblation Catheters (23mm and 28mm)
15739945|NCT04942821|Procedure|Platelet rich fibrin and coronally advanced flap|CAF were used in treatment arms. Root planning was performed on the exposed part of roots to provide more biocompatible surface for re-attachment. Two 10 cc tubes with clot activator were used to collect blood from the patient; blood was centrifuged at 2700 rpm for 12 min. PRF box was used to form fibrin clots into membranes. PRF was positioned at the level of the cemento-enamel junction (CEJ), and sutured on the periosteum bed with 6/0 absorbable sutures. Gingival margins on the flap were placed at least 1 mm coronally of the CEJ and sutured with 5/0 absorbable sutures. Sutures were removed at 2nd week.
15739973|NCT04942626|Radiation|Radiotherapy|PTV: 1.8 Gy to 45 Gy (#28 fractions) to the primary tumor and pelvic lymph nodes; followed by a sequential boost of 1.8 Gy to 9 Gy (#5 fractions) to the gross tumor volume
15739946|NCT04942821|Procedure|Connective tissue graft and coronally advanced flap|Control sites were treated by coronally advanced flap (CAF) combined with connective tissue graft (CTG). CAF were used in both treatment arms. Root planning was performed on the exposed part of roots to provide more biocompatible surface for re-attachment. CTG was obtained with single incision method. CTG was positioned at the level of the cemento-enamel junction (CEJ), and sutured on the periosteum bed with 6/0 absorbable sutures. Gingival margins on the flap were placed at least 1 mm coronally of the CEJ and sutured with 5/0 absorbable sutures. Sutures were removed at 2nd week.
15739947|NCT04942808|Radiation|Periapical radiographs|Periapical radiographs on reevaluation
15739948|NCT04942795|Device|Compliant balloon|Use of a compliant balloon when ADAPT fails to reach the clot site
15739949|NCT04942782|Other|lumbopelvic stabilization exercises|the patients will receive lumbopelvic stabilization in the form of three parts: 1 Segmental control over primary stabilizers (mainly TrA, deep multifidus, pelvic floor and diaphragm) 2-Exercises in closed chain, with low velocity and low load 3-Exercises in open chain, with high velocity and load
15739950|NCT04942782|Other|pilates exercise|the patient will receive pilates exercise in the form of Breast stroke prep, Side leg lift series, One leg circle, Hundreds, Shoulder bridge, and Spine stretch forward
15739951|NCT04942782|Other|conventional therapy|Patients will received strengthening exercises for the abdominal, back, and hip muscles. The patients performed an average of three series of ten repetitions of each exercise. Increases in the number of exercises performed in each session (or load progression) occurred according to individual tolerance
15739952|NCT04942769|Drug|Selenium|selenium 100ug ，take it orally twice daily
15739953|NCT04942756|Device|Continuous Glucose Monitoring|"FSL2 is an integrated continuous glucose monitoring (CGM) system that provides continuous glucose measurements every minute to provide glucose levels, trends and alerts. It is composed by a sensor and a reader. The Sensor, to apply on the back of the arm, continuously measures glucose concentration in interstitial fluid and has an 8-hour memory capacity. The Sensor is factory calibrated, does not require finger stick calibration and can be worn for up to 14 days.
~The reader is a small handheld device that monitors glucose values in real-time to provide alerts and alarms which, when enabled, warn the user of Low Glucose, High Glucose or Signal Loss and prompt the user to scan the Sensor.
~The FSL 2 System is CE mark, it is commercially available and in the current study it is being used in accordance with approved labeling. No modifications of FSL2 System have been performed for the utilization in the current study."
15739954|NCT04942756|Device|Standard Care|"The control group is represented by the usual standard way for blood glucose (BG) monitoring. The control group will use a lancing device for finger samples for collection of blood drop to be put in the test strips to be read in the Glucose meter. Lancing devices, lancets and test strips used in the comparison groups are CE marked and are used according to the user's instructions.
~Monitoring and/or self-monitoring of blood glucose using glucose meters and test strips provides quantitative measurements of fingerstick blood glucose at a single point in time for patients and their healthcare providers to monitor the effectiveness of glycemic control and make more immediate treatment with the right dosage of insulin. The usual standard routine for blood glucose monitoring in patients with DM and with insulin therapy is represented by at least three finger pricks/die according to the usual standards routine of each center."
15739955|NCT04942743|Diagnostic Test|MRI|MRI OF TMJ
15739956|NCT04942730|Drug|Fludarabine|30 mg/m2/day iv x 6 days, days -7 through -2 of HSCT
15739957|NCT04942730|Drug|Bendamustine Hydrochloride|130 mg/m2 iv x 2 days, Days -7 through -6 of HSCT
15739958|NCT04942730|Drug|Busulfan|1 mg/kg po qid x 3 days, Days -5 through -3
15739959|NCT04942730|Drug|Cyclophosphamide|50 mg/kg iv x 2 days, Days +3 through +4
15739960|NCT04942730|Drug|Mycophenolate Mofetil|45 mg/kg/day, maximum 3 g/day, iv or po x 30 days, Days +5 through +35
15739961|NCT04942730|Drug|Tacrolimus 5Mg Cap|0.03 mg/kg/day iv or po, Days +5 through +100 with with further correction by concentration. Target concentration 5-15 ng/ml.
15739962|NCT04942717|Behavioral|CONVO intervention|The CONVO intervention consists of oncology nurse-led discussions exploring patients' health-related values as part of routine oncology care for all patients, from the beginning of oncologic care. Nurses will use the Nurse's Values Discussion Guide. At these sites, chemotherapy nurses will deliver the CONVO discussion, as patients at these sites do not have primary nurses assigned and because oncology doctors, BPs and PAs do not work one-on-one as a pair with a unique nurse.
15739963|NCT04942704|Other|Non interventional Imaging - MRI|MRI Scanning using short protocols
15739964|NCT04942691|Other|physical activity|training with trampoline. Each session lasted sixty minutes. Organization: a 5 minutes warm-up with breathing and mobility exercises from upper to lower body, central phase with jumping exercises involving the total body and 5 minutes of cool-down phase with total body active stretching exercise.
15739965|NCT04942678|Behavioral|10-minute visit with therapy dog and child life specialist handler|A visit from a therapy dog and child life specialist will occur which will last for approximately 10 minutes. Parents and patients will be asked to sanitize their hand prior to the visit. The child life specialist will be instructed to have ad lib conversation with the family. The dog will remain on a leash during the visit. The patient will be free to pet the therapy dog if they wish.
15739966|NCT04942665|Drug|Indocyanine green|Low dose or standard dose ICG will be administered by the anesthesiologist as guided by the study coordinator at the beginning of the case, at two points during the operation (1- prior to the dissection of the biliary tract and 2- upon completion of the dissection and establishment of the critical view of safety).
15739967|NCT04942665|Device|PINPOINT Endoscopic Fluorescence|The PINPOINT Endoscopic Fluorescence Imaging System (Stryker Corporation, Kalamazoo, Michigan) will be used. This device enables the surgeon to simultaneously see real-time, high-definition visible-range and NIR fluorescence videos and to superimpose them. It is currently approved by the FDA for intraoperative near-infrared fluorescence imaging.
15739968|NCT04942652|Drug|Itraconazole 200 mg|Itraconazole 100 mg capsule x 2
15739969|NCT04942652|Drug|Esomeprazole 40 mg|Esomeprazole 40 mg tablet x 1
15739970|NCT04942639|Device|JOE|Audiovisual support by the robot when taking maintenance treatments at home.
15739971|NCT04942626|Drug|Kineret 100 MG in 0.67 ML Prefilled Syringe|Anakinra 100 mg s.c. (Kineret) will be administered from day -10 (i.e. 10 days before initiation of RT) to the last day of RT.
15740556|NCT04937881|Drug|Tenofovir alafenamide|Daily DOT fixed dose combination of 200 mg emtricitabine (FTC) and 300 mg tenofovir disoproxil fumarate (TDF)
15739974|NCT04942626|Procedure|Watch and Wait (cCR) or TME surgery (non-cCR)|Restaging to evaluate tumor response will be conducted 10 weeks after completion of CRT. For patients achieving a clinical complete response (cCR), a Watch and Wait (W&W) option with close follow-up is scheduled. In case of non-cCR, immediate total mesorectal excision (TME) surgery is recommended. According to the current German S3-guidelines, adjuvant chemotherapy is optional.
15739975|NCT04942613|Behavioral|Motivational Interviewing Techniques|Motivational Interviewing Techniques including but not limited to open-ended questions, reflection, affirmations, and summary will be used to build participant rapport, support behavior change (physical activity), and facilitate program engagement.
15739976|NCT04942613|Other|Physical Therapy Interventions|strengthening, balance, functional activities, stretching, breathing, aerobic endurance exercise
15739977|NCT04942613|Other|Education|Education on general health topics which may include the following: basic nutrition, stress reduction, sleep hygiene
15739978|NCT04942600|Device|MagStim Rapid2 Transcranial Magnetic Simulation|A non-invasive method of brain stimulation
15739979|NCT04942587|Behavioral|LISTENING TO THE RECORDINGS SAYING BY PARENTS|The baby was made listen to the lullaby recorded in the voice of parents starting with, during and after the care for 10 minutes.
15739980|NCT04942574|Other|Total sleep deprivation|Participants will perform repeatedly : task of reading with voice acquisition before each MSLT, KSS, VAS-Anxiety, VAS-Fatigue and PVT during the day after a night of total sleep deprivation.
15739981|NCT04942574|Other|Normal sleep|Participants will perform repeatedly : task of reading with voice acquisition before each MSLT, KSS, VAS-Anxiety, VAS-Fatigue and PVT during the day after a night of normal sleep.
15739982|NCT04942561|Device|Samsung Gear VR|Participants 13 -21 years old can use the Samsung Gear VR. The VE is mobile based (Samsung with the Gear VR) and has active matrix LCDs with high pixel resolution, creating a bright, vibrant color and a quality image. Participants will engage with BearBlast (appliedVR™), a multi-sensory VR game in which users travel on a pre-set path through a colorful, highly-interactive 3-D environment filled with animated landscapes, buildings, and clouds, during which the user's gaze controls the direction of a firing cannon to knock down teddy bears. The VR game is equipped with a head-tracking system, enabling the player to look around the VE. Therefore, the child will be receiving distraction via 3-D visual and auditory sensory, thus supplying a multi-sensory immersive experience. While wearing these glasses, the children only can see the HMD screen so that the immersion and presence will be increased. The VR glasses will be sanitized before every use to minimize chance of infection.
15739983|NCT04942561|Device|Merge VR|Participants 10-21 years can use the Merge. The VE to be used in this study is mobile based (Pixel with the Merge) and has active matrix LCDs with high pixel resolution, creating a bright, vibrant color and a quality image. Participants will engage with BearBlast (appliedVR™), a multi-sensory VR game in which users travel on a pre-set path through a colorful, highly-interactive 3-D environment filled with animated landscapes, buildings, and clouds, during which the user's gaze controls the direction of a firing cannon to knock down teddy bears. The VR game is equipped with a head-tracking system, enabling the player to look around the VE. Therefore, the child will be receiving distraction via 3-D visual and auditory sensory, thus supplying a multi-sensory immersive experience. While wearing these glasses, the children only can see the HMD screen so that the immersion and presence will be increased. The VR glasses will be sanitized before every use to minimize chance of infection.
15739984|NCT04942548|Other|Ketogenic Diet|Ketogenic diet intervention that is high in fat and low in carbohydrates, causing the body to induce a state of metabolic ketosis, whereby fat is broken down into ketones to provide an energy source for the body.
15739985|NCT04942535|Behavioral|Social Incentive Gamification|"Participants enroll as a family team. They are asked to use a Fitbit activity tracker daily. Each participant sets a daily step goal based on their baseline step count.
~Each participant signs a pre-commitment contract. Participants are entered into a game with their family members. Each family receives 70 points weekly. Each day, a family member is selected at random to represent the family. If that person's step goal was achieved on the prior day, the family keeps its points; if not, they lose 10 points.
~At the end of the week, if the family has 40 points or more, they advance one level. If they have less than 40 points, the family drops down one level. Each family team starts in the middle of 5 levels.
~At the end of the intervention period, families in the top 2 levels receive a small physical gift.
~In the 6 month follow-up period, participants receive a daily text message stating whether or not they achieved their step goal on the prior day."
15739986|NCT04942535|Behavioral|Social Goals through Incentives to Charity|"Participants enroll as a family team. They are asked to use a Fitbit activity tracker daily. Each participant sets a daily step goal based on their baseline step count.
~Families select a charity at the beginning of the intervention. They are informed that $20 is available each week to be donated to a charity of their choice. Each day, a family member is selected at random to represent the family. If that person's step goal was achieved on the prior day, the family gets credit for meeting their goal; if not, the entire family does not get credit.
~If the family achieves their goal on at least 4 of 7 days in a week, $20 is donated to charity.
~In the 6 month follow-up period, participants receive a daily text message stating whether or not they achieved their step goal on the prior day."
15739987|NCT04942535|Behavioral|Daily Performance Feedback|"Participants enroll as a family team. They are asked to use a Fitbit activity tracker daily. Each participant sets a daily step goal based on their baseline step count.
~Participants receive a daily text message stating whether or not they achieved their step goal on the prior day."
15739988|NCT04942522|Biological|probiotics PS128|6×10^10 CFU/capsule
15739989|NCT04942522|Drug|placebo (Microcrystalline cellulose )|450 mg/capsule
15739990|NCT04942509|Behavioral|Coloring as a brief mindfulness-based intervention|Participants watched an instructional video on mindful coloring at the beginning of the intervention and colored mindfully for at least 5 days or 100 minutes in total during a 10-day period. The intervention included a coloring booklet that contained mandala patterns for coloring.
15739991|NCT04942496|Drug|Chlorhexidine Gluconate|Antimicrobial Skin Wash
15739992|NCT04942496|Device|Hibi Universal Bathing System|Cloths used for patient bathing
15739993|NCT04942496|Other|0.1% SLS|Positive control
15739994|NCT04942496|Other|Distilled Water|Negative Control
15740280|NCT04940156|Device|Confirm Rx (Implantable Cardiac Monitor)|Confirm Rx implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED)
15739995|NCT04942483|Diagnostic Test|Blood eosinophil count|Peripheral blood eosinophil count will be measured from a finger prick blood sample, using the Haemocue machine, allowing a result in approximately 2 minutes. The test will allow to assess the presence or not of eosinophilia and if it can predict future wheezing exacerbations and response to inhaled corticosteroids (ICS).
15739996|NCT04942483|Diagnostic Test|Atopic sensitization|Skin prick tests will be performed to: (a) house dust mite, (b) grass pollen, (c) tree pollen, (d) cat hair, (e) dog hair, as well as normal saline and histamine which will act as negative and positive controls respectively. In addition, skin prick tests will allow the assessment of which aeroallergen is the most useful predictor of outcomes in preschool children.
15739997|NCT04942483|Diagnostic Test|FeNO (offline method)|The child will breathe normally into a sample bag that will be collected for later analysis of FeNO levels. The test will be performed twice.
15739998|NCT04942470|Other|Aloe vera and propolis applied|Suitable of sterile pads containing aloe vera and propolis to the area with pressure sores
15739999|NCT04942457|Behavioral|Fasting|Prolonged fasting for 7-10 days (caloric intake <500 kcal in liquid form)
15740000|NCT04942457|Behavioral|Weight-loss|8 x dietary counselling for weight-loss
15740001|NCT04942457|Behavioral|Counselling on nutrients|1 x dietary counselling on important nutrients while trying to conceive, usual diet should be maintained
15740002|NCT04942444|Other|Dry needling|One-hour weekly session of DN in the 18th tender points during 6 weeks in the DNG, apart from continuing their medical treatment. The CG continue with the habitual medical treatment.
15740003|NCT04942431|Behavioral|Rebirth active SCHOOL 2.0 movement program|60 Minutes of physical activity per day integrated in every school-day.
15740004|NCT04942418|Other|Multicolor hybrid ceramic laminate veneers.|Multi shaded blocks have been recently introduced to the market, due to lack of evidence in clinical performance evaluating marginal adaptation and shade matching of the polychromatic newly introduced blocks comparing their different color gradient. Multicolor hybrid ceramic laminate veneers.
15740005|NCT04942418|Other|Multicolor fieldspathic ceramic laminate veneers.|the feldspathic ceramic blocks display the highest translucent properties of all ceramic blocks which make them the first choice in the esthetic zone. esthetic and translucency with polychromatic feature and resilience properties.
15740008|NCT04942392|Device|Digital dance for PD|The digital dance class was held via Zoom. The class was scheduled once a week for 60 min and consisted of 10 sessions. A professional, certified Dance for PD and experienced dance instructor was teaching the dance class. The dance classes followed the Dance for PD protocol yet was adjusted to fit the digital zoom format.
15740009|NCT04942379|Other|Asthma Link|Providers enroll patients in school nurse supervised daily controller asthma medication delivery
15740010|NCT04942379|Other|Enhanced Usual Care|Providers counsel patients on behavioral strategies to improve medication adherence. Patients also receive an asthma workbook outlining behavioral strategies for asthma medication adherence.
15740011|NCT04942366|Other|High intensity interval training|HIIT using treadmill four sets of 4 minute interval session (at 90%-95% of the individual HR max calculated by using the karvonen method) and each set will be followed by three minute of moderate intensity exercise (at 70% of individual HR max).
15740012|NCT04942366|Other|Strength training|Strength training will be performed thrice a week, each session will consist of eight dynamic drills.
15740013|NCT04942353|Behavioral|Home-based Exercise Rehabilitation.|Based on physical therapist or exercise physiologist assessment, subjects will receive an individualized exercise prescription for frequency, duration, and intensity of walking and strength training (including exercises using light-weight hand-weights and upper and lower body exercises using resistance bands). Research team will provide updated exercise prescription based on Garmin watch/Datos app activity data and Datos app data (including Borg scale).
15740014|NCT04942353|Behavioral|Usual Care|Patients receive a standardized recommendation to increase their walking activity to 30 minutes 5 days/week.
15740015|NCT04942340|Drug|Atipamezole & Caffeine|In this arm, subjects will be infused with Atipamezole (2 g/kg) and caffeine (15 mg/kg) across 5 minutes
15740016|NCT04942340|Drug|Dexmedetomidine Hydrochloride & Saline|In this arm, subjects will be infused with Precedex & Saline at 15 mg/kg across 5 minutes
15740018|NCT04942301|Drug|Endostar|This product combined with other combined chemotherapeutics is used to treat patients with stage III/IV NSCLC who are newly treated or relapsed
15740019|NCT04942301|Device|use the vein pump to pump drugs|During the first 14 days of the first cycle, the experimental drug was pumped daily with an intravenous pump. During cycles 2-4, subjects in group A were pumped with experimental drugs for 3 days and subjects in group B were pumped with experimental drugs for 7 days.
15740020|NCT04942301|Combination Product|combination therapy|Combination therapy with chemotherapy drugs was used
15740021|NCT04942288|Other|The first group is acupressure and massage, the second group is massage|In the study, acupressure + massage will be applied to one group during 3 menstrual cycles and in the first 3 of the menstrual cycles, and only to the other group by the researcher in the experiment groups with dysmenorrhea.
15740022|NCT04942275|Drug|Pre-therapeutic imaging test|The radiopharmaceutical used for lung perfusion PET consists in human albumin macroaggregates labeled with Ga-68 (68Ga-MAA). 68Ga- MAA are administrated intravenously.
15740023|NCT04942262|Drug|denture adhesive (Polident®, GlaxoSmithKline, Ireland)|cream-type denture adhesive available as an over-the-counter product in Thailand
15740024|NCT04942249|Other|No intervention|No intervention
15740063|NCT04941976|Drug|Single 3 mg lozenge of benzydamine hydrochloride (mint flavour)|"Single 3 mg lozenge of benzydamine hydrochloride (mint flavour). Drug applications will be performed at the investigational site, on the morning of Visit 0.
~In case of persistent sore throat patients will continue the assigned treatment at home, according to the local SmPC and up to one week, until the symptoms' resolution."
15740025|NCT04942223|Device|guided bone regeneration|After local anesthesia, the surgery started with a mid-crestal incision with vertical releasing cuts followed by the full-thickness buccal and lingual/palatal flaps raising to expose the bone defect completely. The flaps were coronally extended to assure a complete closure with a passive suture above the titanium. Subsequently, an intra-oral mandibular ramus bone cortical block was harvested in the molar zone. The bone block was milled and mixed with freeze-dried. The particulate graft was put to fill the deficit above the mesh until its perfect stability and unity with the defect's borders. Two or three titanium mini-screws were used to stabilize the device , and the flaps were carefully sutured. Ceftriaxone was administered intravenously at a loading dose of 2 g; together with a non-steroidal analgesic, it was continued at two g/die per os beginning the day after surgery and continuing for six days.
15740026|NCT04942210|Biological|Yellow fever vaccine (produced on serum-free Vero cells)|Powder and diluent for suspension for injection Subcutaneous injection
15740027|NCT04942210|Biological|Yellow fever vaccine|Powder and diluent for suspension for injection Subcutaneous injection
15740028|NCT04942197|Other|use pregnancy management application|Pregnant women who used pregnancy management application, which tells patients what she need to know during pregnancy, when to perform tests, and what precautions to take for your baby.
15740029|NCT04942184|Behavioral|Memory strategies in Arm 1|Memory strategies will consist of daily at-home exercises lasting between 20 minutes to 1 hour depending on the memory tasks assigned to each participant. At the start of week 1 participants will be taught the memory strategies to use while completing the daily memory tasks. In week 1 and 2, subjects will be reminded daily to use the memory strategies. At the start of week 3, subjects will be advised to use the memory strategies however they will not be given daily reminders.
15740030|NCT04942184|Device|Electroencephalogram (EEG) headset in Arm 1|A cap that measures brain activity using a 16-sensor wireless dry (no gel applied) EEG device designed by BrainWaveBank Ltd., that uses Bluetooth technology to securely transmit EEG signals to an Android tablet. The cap will be used during week 1,2,3 and 4.
15740031|NCT04942184|Other|Tablet in Arm 1|A computer tablet will be provided to each participant that will have daily reminders about the memory strategies during week 1 and 2, while no reminders will be present in week 3 and 4. The tablet software includes a user-friendly interface that provides feedback and instructions that help the participant properly wear the EEG headset. At the end of each session the tablet stores behavioral and EEG data on a secured server accessible by the research staff.
15740032|NCT04942184|Behavioral|Memory strategies in Arm 2|Memory strategies will consist of daily at home exercises lasting between 20 minutes to 1 hour depending on the memory tasks assigned to each participant. During weeks 1 and 2, participants will be completing the memory tasks without being instructed to use any specific strategy. At the end of week 2 subjects will be taught the memory strategies and during week 3 and 4, they will be reminded daily to use the memory strategies while completing the memory tasks.
15740033|NCT04942184|Device|Electroencephalogram (EEG) headset in Arm 2|A cap that measures brain activity using a 16-sensor wireless dry (no gel applied) EEG device designed by BrainWaveBank Ltd., that uses Bluetooth technology to securely transmit EEG signals to an Android tablet. The cap will be used during week 1,2,3 and 4.
15740034|NCT04942184|Other|Tablet in Arm 2|A computer tablet will be provided to each participant. During week 3 and 4, the tablet will present daily reminders to use memory strategies while completing the memory tasks. The tablet software includes a user-friendly interface that provides feedback and instructions that help the participant properly wear the EEG headset. At the end of each session the tablet stores behavioral and EEG data on a secured server accessible by the research staff.
15740035|NCT04942171|Procedure|Atrial fibrillation catheter ablation group|"Pulmonary vein isolation
~Additional treatment for lesions caused by non-pulmonary veins
~Esophageal temperature monitoring to prevent damage to the esophagus
~Evaluation of procedure time and radiofrequency ablation time
~Evaluation of complications after the procedure
~Rhythm follow-up after the procedure is conducted in accordance with the above study design.
~Conduct a survey on cognitive function and emotion before and 12 months after the procedure"
15740036|NCT04942171|Drug|Medical therapy group|"Use of beta-blockers or calcium channel blockers for pulse rate control
~Antiarrhythmic drugs are administered to patients with highly symptomatic atrial fibrillation symptoms even after pulse rate control.
~If symptoms are not controlled even with antiarrhythmic drugs, electrical conversion to restore sinus rhythm.
~To prevent cerebral infarction, maintain optimal anticoagulant therapy according to the risk score for cerebral infarction.
~Conduct a questionnaire on cognitive function and emotion before and 12 months after the procedure"
15740039|NCT04942145|Device|virtual reality in dental patients|"The behavioral anxiety response of dental patients (with and without virtual reality) related to psychological factors is studied.
~Participants self-complete the questionnaires"
15740064|NCT04941963|Other|No intervention|Patients will undergo ultrasound scanning, no actual intervention
15740065|NCT04941950|Behavioral|PlaySmart|PlaySmart is designed to provide players with behavioral skills and knowledge through repetitive and engaging videogame play to target adolescent perception of risk of harm from initiating opioid misuse.
15740040|NCT04942132|Behavioral|Cognitive-behavioral (CBT)|Treatment includes a smartphone-delivered CBT program designed to improve the quality of life of individuals with chronic pain. The treatment is condensed in nine weeks, and contains the following modules or units of treatment: sleep quality, anxiety management, pain coping, medication use, physical conditioning, mood regulation, problem solving, decision-making and relationships with others. All the content and settings are written in Spanish.
15740041|NCT04942119|Other|Multifactorial intervention|"Correction of magnesium and/or potassium deficit and the underlying disease.
~Education reinforcing optimal diet and exercise, in addition to, post-nutrition assessment , diabetes self-care activities and adherence will be given at each follow up visit by a specialized dietitian.
~Comprehensive medication therapy management by clinical pharmacist, and medication adherence will be measured by adherence questionnaire as well as fixed medication possession ratio (FMPR)."
15740042|NCT04942106|Other|Arm 1 - Side-lying position followed by Supine position|Infants will be observed for two bottle feedings in a single day when they are receiving at least 30% and no more than 50% of feedings orally. In this arm, infants will be bottle-fed in the side-lying position first followed by the supine position. In the side-lying feeding position, the infant will be placed on the caregiver's lap with one ear and hip facing the ceiling at a 45 to 60 degree angle. In the supine feeding position, the infant will be placed facing the caregiver in a reclining position at a 45 to 60 degree angle. In both feeding positions, the infant's head, neck, and upper body will be supported by the caregiver to maintain a neutral straight alignment with the chin tilted down slightly without the neck being extended or in excessive flexion. The infant will also be loosely swaddled with a single blanket so their legs, shoulders, and elbows are supported in a flexed position but with the lower arms free to move.
15740043|NCT04942106|Other|Arm 2 - Supine position followed by Side-lying position|Infants will be observed for two bottle feedings in a single day when they are receiving at least 30% and no more than 50% of feedings orally. In this arm, infants will be bottle-fed in the supine position first followed by the side-lying position. In the side-lying feeding position, the infant will be placed on the caregiver's lap with one ear and hip facing the ceiling at a 45 to 60 degree angle. In the supine feeding position, the infant will be placed facing the caregiver in a reclining position at a 45 to 60 degree angle. In both feeding positions, the infant's head, neck, and upper body will be supported by the caregiver to maintain a neutral straight alignment with the chin tilted down slightly without the neck being extended or in excessive flexion. The infant will also be loosely swaddled with a single blanket so their legs, shoulders, and elbows are supported in a flexed position but with the lower arms free to move.
15740044|NCT04942093|Dietary Supplement|With low-calorie, high-protein diet|A low-calorie, high-protein diet will be prescribed to the patient for a period of 4 weeks. The diet will be done the 4 weeks before the bariatric surgery
15740045|NCT04942093|Dietary Supplement|Without low-calorie, high-protein diet|A low-calorie, high-protein diet will not be prescribed to the patient for a period of 4 weeks.
15740046|NCT04942080|Biological|CALR allele burden quantification|"DNA extraction from blood sample for CALR mutation quantification (fragment analysis)
~at diagnosis and follow-up (inclusion period: 3 years)
~max 1 sample/year
~secondary outcome: mutational landscape by Next Generation Sequencing (NGS) analysis at diagnosis"
15740047|NCT04942067|Drug|APG2575+ Pd|APG 2575 + Pomalidomide 4mg QD x 21 days + dexamethasone (40 mg for patients ≤ 75 years old or 20 mg for patients > 75 years old) on Days 1, 8, 15, and 22 of a repeated 28-day cycle
15740048|NCT04942067|Drug|APG2575 + DRd|APG2575+ Lenalidomide administered at a dose of 25 mg orally (PO) on Days 1 through 21 of each 28-day cycle, dexamethasone will be administered at a dose of 40 mg (or 20 mg for patients > 75 years old) once weekly, and daratumumab will be administered intravenously at a dose of 16 mg/kg (or 1800 mg administered subcutaneously if commercially available) weekly in cycles 1 and 2 and then every 2 weeks in cycles 3 to 6 and every 4 weeks thereafter.
15740052|NCT04942041|Other|Simulation based quality program|Stroke team simulation. Virtual reality task training simulation.
15740053|NCT04942028|Behavioral|Exposure|Systematic confrontation with stimuli associated with symptom-related distress, to achieve therapeutic changes in cognitions or behavior
15740054|NCT04942028|Behavioral|Standardized education|Standardized routine care education for individuals suffering from distress related to somatic symptoms, primarily focusing on healthy lifestyle behaviors such as sleep, diet, and exercise
15740055|NCT04942028|Behavioral|Prolonged assessment|Patients are encouraged to keep a rudimentary symptom diary to track if and how their symptoms interact with mood and lifestyle behaviors
15740056|NCT04942015|Drug|Honghuaruyi Wan|Honghuaruyi Wan is the traditional Tibetan prescription, clinical research has proved that Honghuaruyi Wan can significantly reduce risk mouse dysmenorrhea caused by oxytocin, improve dysmenorrhea model of mice body torsion times and improve the estrogen and progestogen operator Netherlands rat pituitary estradiol and prolactin level, at the same time also can reduce the amount of TNF alpha, thus improving endometriosis dysmenorrhea.(Pill (15 pills/plate ×2 plates/box))
15740057|NCT04942015|Drug|Placebo of Honghuaruyi Wan|Honghuaruyi Wan simulation agent. Made of starch,dextrin and edible pigment from Tibet Qizheng Tibetan Medicine Co.,Ltd. ( Pill (15 pills/plate ×2 plates/box))
15740058|NCT04942002|Drug|Methylprednisolone Acetate 40 MG/ML [Depo-Medrol]|Retrobulbar injection performed by care provider
15740059|NCT04942002|Drug|Placebo Comparator: Standard treatment + placebo|Intravenous Methylprednisolone succinate (1 g daily for 5 days) + paraocular injection of 0.9% saline solution by care provider
15740060|NCT04941989|Drug|HTL0022562|HTL0022562
15740061|NCT04941989|Drug|Placebo|Placebo
15740062|NCT04941976|Drug|0.3% benzydamine hydrochloride spray oromucosal solution|"Single application of 0.3% benzydamine hydrochloride spray oromucosal solution. Drug applications will be performed at the investigational site, on the morning of Visit 0.
~In case of persistent sore throat patients will continue the assigned treatment at home, according to the local SmPC and up to one week, until the symptoms' resolution."
15740066|NCT04941950|Other|Video Game Control|Participants in the control group will play another video game with no intended effect similar to PlaySmart.
15740281|NCT04940156|Device|Reveal LINQ (Implantable Cardiac Monitor)|Reveal LINQ implanted in patients with atrial fibrillation detected on their cardiac implantable electronic device (CIED)
15740067|NCT04941937|Drug|Selinexor|Selinexor (ATG-010# is a first-in-class, oral selective exportin 1 (XPO1) inhibitor (1,2). Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus along with inhibition of translation of oncoprotein mRNAs. Selinexor 60mg/d QW
15740068|NCT04941937|Drug|Thalidomide|100mg/d, Po. on day1-28
15740069|NCT04941937|Drug|Lenalidomide|PO,Lenalidomide 25mg once daily from D1-21
15740070|NCT04941937|Drug|Pomalidomide|Pomalidomide will be given at 4mg once daily for 21 days in a 28-day cycle, PO.
15740071|NCT04941937|Drug|Dexamethasone|Dexamethasone will be given at a dose of 40mg orally once a week for 4 weeks (D1,8,15,22).
15740072|NCT04941924|Procedure|Intraductal Radio-Frequency Ablation|"The electrode employed in this study is the STARmed ELRA™ (Endo Luminal Radiofrequency Ablation) electrode; this is a CE marked device. The selected electrode will be connected to the VIVA™ Combo generator (also a CE marked device) and advanced over the guide wire.
~The power of the generator should be set at either 7 or 10 W depending on the electrode used per manufacturer instructions. An ablation should then be applied at a temperature of 70 to 80℃ for 2 minutes. For longer length strictures or stent occlusions, the RFA probe is withdrawn from proximal to distal in a step by step fashion in respect to the access method used."
15740073|NCT04941924|Device|Biliary Stent Placement|Taewoong Niti-S™ LCD Biliary stents (CE marked uncovered self-expanding metal stents) placed according to standard local practice.
15740074|NCT04941911|Drug|Octreotide Acetate|Octreotide syringes will contain 50ml of octreotide acetate at 20mcg/ml in 0.9% w/v sodium chloride in water.
15740075|NCT04941911|Other|Placebo|Sodium chloride 0.9% w/v
15740076|NCT04941898|Biological|PEGylated Recombinant Factor VIII|Polyethylene glycol (PEG)-ylated full-length recombinant FVIII (rFVIII)
15740077|NCT04941885|Drug|Inetetamab Plus Cyclophosphamide Metronomic Chemotherapy Plus AI|Each participant receives Inetetamab plus cyclophosphamide metronomic chemotherapy plus AI.
15740078|NCT04941872|Diagnostic Test|68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2 PET/CT|Each subject receive a single intravenous injection of 68Ga-DOTA-FAPI-46 and 68Ga-DOTA-2P(FAPI)2, and undergo PET/CT imaging within the specified time.
15740079|NCT04941859|Behavioral|acupoint massage and application|Patients in the experimental group were treated with acupoint application combined with acupoint massage on the basis of standard treatment for acute poisoning. When the patient began to launder the stomach, the acupoint was applied to Shenque (umbilical). After the end of the gastric launder, Shenque acupoint and Zusanli diarrhea method (referring to counterclockwise and strong stimulation) were massaged for 15 minutes, and the massage frequency was Q8H.
15740080|NCT04941846|Drug|nimodipine and euvolemia|administered nimodipine to prevent vasospasm, and euvolemia was maintained via intravenous hydration
15740081|NCT04941833|Drug|Desogestrel Oral Tablet|Cerazette is the brand name of the desogestrel which contain of 0.075 mg of desogestrel
15740082|NCT04941820|Other|clinical pharmacist intervention|clinical pharmacist intervention
15740083|NCT04941807|Device|Platelet-rich plasma|Blood will be drawn from a vein in the patient's arm into an 11 ml Eclipse platelet-rich plasma Tube. The blood is processed using a centrifuge machine from eclipse medical. After centrifugation, the platelet poor portion will be separated from the platelet-rich portion. The proximal nail folds are cleansed with alcohol. Using a 1ml syringe and 30g needle, 0.1-0.2 ml of platelet-rich plasma is injected into 8 proximal nail folds.
15740084|NCT04941807|Device|Platelet-poor plasma|Blood will be drawn from a vein in the patient's arm into an 11 ml Eclipse platelet-rich plasma Tube. The blood is processed using a centrifuge machine from eclipse medical. After centrifugation, the platelet poor portion will be separated from the platelet-rich portion. The proximal nail folds are cleansed with alcohol. Using a 1ml syringe and 30g needle, 0.1-0.2 ml of platelet-poor plasma is injected into 2 proximal nail folds.
15740085|NCT04941781|Drug|PIPE-307|"Each dose cohort will receive a single oral dose of PIPE-307. Doses to be tested in subsequent cohorts will be determined by the analysis of the exposure from PK data and the PET scans with [11C] PIPE-307.
~Subjects will receive an intravenous dose of the radioligand [11C] PIPE-307 prior to PET imaging."
15740086|NCT04941755|Drug|BMS-986256|Specified dose on specified days
15740087|NCT04941755|Drug|Famotidine|Specified dose on specified days
15740088|NCT04941729|Device|OR3O™ - Dual Mobility System|OR3O™ Dual Mobility System is comprised of a diffusion-hardened, oxidized zirconium acetabular liner (OR3O™ Liner), and an insert of highly cross-linked polyethylene (OR3O™ XLPE Insert).
15740089|NCT04941729|Device|Conventional|A conventional, single-bearing design Total Hip System comprised of R3™ Acetabular Shell with XLPE liner and a Smith & Nephew Oxinium (Ox) femoral head.
15740090|NCT04941716|Drug|Acalabrutinib|Given PO
15740091|NCT04941716|Drug|Venetoclax|Given PO
15740092|NCT04941703|Drug|Magnesium Citrate plus probiotic|296 ml magnesium citrate
15740093|NCT04941690|Other|A questionnaire method was used.|The questionnaire included general population information, International Index of Sexual Function-5 (IIEF-5), Premature Ejaculation Diagnostic Tool (PEDT), General Anxiety Disorder-7 and CPSI.
15740094|NCT04941677|Other|no intervention|no intervention in this study
15740095|NCT04941664|Drug|0.5% levobupivacaine|"This study adopts a Modified Narayana rule (MNR), a sequential up-and-down pharmacodynamics method (UDM) to estimate the minimum effective local anesthetic volume of 90% (MELVA90) of cases of the aforementioned local anesthetic (LA), in order to produce the surgical anesthesia of the patients scheduled for shoulder surgeries. Based on the principal investigator's clinical experience, the initial volume of 8ml will be used. Depending on the success or failure of the superior trunk block, which is defined as the readiness for surgery at 30 minutes after the block, the volume for the next patient will be adjusted up or down by 2ml. The upper dose limit of the study to minimize the potential for local anesthetic systemic toxicity will be 16ml and the lower dose limit will be 4ml, which will be of no clinical importance."
15740121|NCT04941482|Device|Functional near-infrared spectroscopy|The fNIRS devices as an effective monitoring and therapeutic tool, evaluating the evolution of neural activity and stroke rehabilitation and recovery. Moreover, the cortex hemodynamic measure by fNIRS may detect early various mental disorders such as depression, anxiety, schizophrenia... through cognitive tasks.
15740450|NCT04938843|Dietary Supplement|F. prausnitzii and D. piger|Dietary supplementation with capsules containing F. prausnitzii and D. piger once daily for 12 consecutive weeks
15740096|NCT04941651|Behavioral|OBE-COACH program|"OBE-COACH works through private exchanges between the user and an automatic generator of recommendations, advice and messages of encouragement. Web focus groups are propoposed by specialist to respond to the questions of the participants and a tele-interview at 6 months with a dietetician to encourage and assist the patient to make the best use of the program.
~The program is divided into missions to perform. These missions are grouped into 10 families. The completion of each mission and the correct answers to the quiz offer points and bonuses.
~To promote better adherence to the program, missions are not repetitive. They are proposed to surprise the user and constantly renew his desire to connect to the program and achieve goals.
~The intensity level of the program is selected by the user at any time."
15740097|NCT04941651|Device|Connected devices|"Connected devices provide to patient are auto-tensiometer and balance. These devices will not be connected to the OBE-COACH program.
~The auto-tensiometer (Tensio-screen, Terraillon) is a connected tensiometer allowing the patient to measure by himself with an armband his systolic and diastolic blood pressure and his heart rate.
~The balance (Web coach premium, Terraillon) is a connected scale to collect body weight."
15740098|NCT04941651|Device|Connected Activity Tracer|The Activity Tracer (activi-T band, Terraillon) is a a wristband connected activity tracer worn on the wrist that tracks the patient's physical activity and calculates the number of steps, distance traveled and calories burned. The Activity Tracer will not be connected to the OBE-COACH program.
15740099|NCT04941651|Behavioral|e-learning program|e-learning program with free access via the web to advice sheets, a menu generator and a catalog of physical activity (resources made available by the site www.mangerbouger.fr ; Public Health France, Ministry of Health)
15740100|NCT04941638|Procedure|Distal radial access|Vascular access for primary PCI in patients with STEMI
15740101|NCT04941625|Diagnostic Test|serum cystatin C|blood sampling
15740102|NCT04941625|Diagnostic Test|serum beta-microglubulin|blood sampling
15740103|NCT04941625|Diagnostic Test|urine|neutrophil gelatinase-associated lipocalin
15740104|NCT04941612|Device|Activa IM-Nail|PLGA bioabsorbable intramedullary nail
15740105|NCT04941599|Drug|2-Hydroxybenzylamine|2-Hydroxybenzylamine (2-HOBA) 250 mg three tabs TID (po) for 6 weeks.
15740106|NCT04941599|Other|Placebo|Placebo 250 mg three tabs TID (po) for 6 weeks.
15740107|NCT04941586|Other|Education in pain, Manual Therapy and Exercises|twice a week, lasting 60 minutes, for one month
15740108|NCT04941586|Other|Manual Therapy and Exercises|twice a week, lasting 40 minutes, for one month
15740109|NCT04941573|Combination Product|Hyperpolarized 129-Xenon (MagniXene) MRI of the lung|Hyperpolarized xenon is a contrast imaging agent for lung MR imaging. Inert noble gas xenon is hyperpolarized using Xemed developed technology. The gas is administered to the human subjects as a short seconds-long breath-hold while inside the MRI scanner. Once the gas is inhaled, lung images of HP Xenon distributed within the lung spaces can be acquired. Additionally, xenon follows a similar path to oxygen, dissolving in lung tissue and further in bloodstream.
15740110|NCT04941560|Other|No intervention|No intervention
15740111|NCT04941521|Drug|Exenatide 2 mg [Bydureon]|Exenatide will be purchased commercially as Bydureon® for subcutaneous (SC) injection and administered at a dose of 2 mg once a week for a total of 6 weeks. Each single-dose, dual-chamber pen contains 0.65 mg of diluent and 2 mg of exenatide, which remains isolated until mixed.
15740112|NCT04941521|Behavioral|Drug Counseling|Once weekly drug counseling sessions for cocaine use with trained masters-level therapists.
15740113|NCT04941508|Behavioral|the mother's recorded voice|Children will be assigned to listen to the mother's recorded voice at 2 times (in the holding area 3 minutes before induction of anesthesia till induction of anesthesia is ended) and (during emergence from anesthesia till complete recovery).
15740114|NCT04941508|Drug|Dexmedetomidine|Children will be given a single bolus of dexmedetomidine 0.2 µ/kg IV at 2 times (in the holding area 3 minutes before induction of anesthesia) and (at the end of surgery).
15740115|NCT04941508|Other|saline 0.9% placebo|Children will be given the same volume of saline at 2 times (in the holding area 3 minutes before induction of anesthesia) and (at the end of surgery).
15740116|NCT04941495|Other|conventional physiotherapy|"TENS for 15 minutes on Constant Mode according to patient comfort.
~Infrared for 15 minutes.
~Isometric exercises: Isometric neck flexion, extension, side bending exercises were given. 3 sets of 10 repetitions each were given. And resistance was given for 6-8 seconds for each movement.
~Stretching exercises: Passive stretching for Sternocleidomastoid, short sub occipital muscles, Trapezius & Scalene, Pectoralis Major was given. 3 sets of 10 reps were given and each stretch was maintained for 10 seconds.
~Home Plan: self stretches and isometrics.
~Postural Education: posture correction in daily life activities in sitting, walking, lying."
15740117|NCT04941495|Other|Cervical proprioceptive training|"TENS for 15 minutes on Constant Mode according to patient comfort.
~Infrared for 15 minutes.
~Isometric exercises: Isometric neck flexion, extension, side bending exercises were given. 3 sets of 10 repetitions each were given. And resistance was given for 6-8 seconds for each movement.
~Stretching exercises: Passive stretching for Sternocleidomastoid, short sub occipital muscles, Trapezius & Scalene, Pectoralis Major was given. 3 sets of 10 reps were given and each stretch was maintained for 10 seconds.
~Home Plan: self stretches and isometrics.
~Postural Education: posture correction in daily life activities in sitting, walking, lying.
~The patients wearing a cap with a laser pointer attached to it were seated three feet away from the target A, B and C. Start Chart A with a 3 cm, chart B 2cm and chart C 1cm narrow pathway were presented to the patients. The time taken by the patient to complete the pathway without any error was noted."
15740118|NCT04941482|Behavioral|Periodic health check program for post-stroke|The stroke survivors will be assessed their physical and mental health, recurrence risks, and harmful behaviors at 0, 1, 3, and 6 months by specific scales.
15740119|NCT04941482|Behavioral|Guiding the appropriate rehabilitation exercises|The appropriate rehabilitation exercises will be designed and guided for each patient and they will be followed up by the daily online report.
15740120|NCT04941482|Behavioral|Motivational Interviewing|Motivational Interviewing will carry out on post-stroke patients in the first three months (one time per week in the first month and one time per the second and third month). This intervention method aims to discover and resolve patient's conflicts by a standardized communication skill to improve their mental health and change negative behaviors.
15740207|NCT04940754|Procedure|osteosynthesis|Closed reduction, internal fixation
15740208|NCT04940741|Drug|VER-01|standardised cannabis extract (containing 21 mg THC per gram drug product)
15740122|NCT04941469|Device|Specifically optimized off-the-counter foot orthosis (Medical grade foot orthosis)|"The study device is a specifically optimized off-the-counter foot orthosis modified by an additional wedging added onto the original Formthotics (Original Dual Hard) with standard arch fill reduction to achieve a foot orthosis that is tailored for the management of mechanical foot pains in the Subtle Cavus foot type. The original Formthotics (Original Dual Hard) is currently in use and is considered a Class A medical device according to the Health Science Authority of Singapore risk classification system. At the moment, the original Formthotics (Original Dual Hard) is also available in the retail market, abeit, without assessment guided optimisations for specific feet types."
15740123|NCT04941469|Device|Plain off-the-counter foot orthosis (Medical grade foot orthosis)|The control device for this study would be the plain original Formthotics (Original Dual Hard).
15740124|NCT04941456|Other|Open Tracheostomy|Participants will perform the six minute walk test with an open tracheostomy. Participants will complete 3 session over approximately three-weeks.
15740125|NCT04941456|Device|PMV in place|Participants will perform the six minute walk test with a PMV in place. Participants will complete 3 sessions over approximately three-weeks.
15740126|NCT04941443|Drug|Methadone Pill|All participants will be given a 5mg methadone tablet to be taken immediately following the misoprostol dose.
15740127|NCT04941443|Drug|Ibuprofen|All participants will be provided additional analgesics (ibuprofen 800mg x4 tabs) available for use as needed every eight hours.
15740129|NCT04941417|Drug|PD-1 inhibitor|Two to three cycles of neoadjuvant chemotherapy in combination with PD-(L)1 inhibitor will be administered before surgery, followed by another one to two cycles of neoadjuvant chemotherapy in combination with PD-(L)1 inhibitor and PD-(L)1 inhibitor monotherapy for up to 1 year.
15740130|NCT04941404|Drug|TQ05105 tablets|Participants began oral administration of TQ05105 tablets at 10 mg twice daily (BID),followed by 5 mg or 15 mg BID depending on the situation of the study. twice daily in 28-day cycle until disease progression/intolerance occurs or the sponsor terminates the study.
15740132|NCT04941378|Drug|OTL38|One time infusion of OTL38
15740133|NCT04941378|Device|intraoperative imaging camera system|intraoperative imaging camera system
15740134|NCT04941365|Diagnostic Test|single arm|Blood samples will be collected at baseline(Visit 1), and during therapy at visit 2 (around one month after the treatment starting) and at Visit 3 (around three months after the treatment starting. And, optionally, in case of a disease progression (PD).
15740135|NCT04941352|Behavioral|6-session Interpersonal Relations Theory-based Motivational Interviews and 3 month follow-up.|6-session Interpersonal Relations Theory-based Motivational Interviews were applied to the individuals in the study group. All sessions were conducted face-to-face in the form of individual interviews. Each interview lasted an average of 30-40 minutes. With this intervention, it was aimed to increase treatment cooperation and motivation in individuals with schizophrenia, to increase insight, to improve adherence to treatment, daily living skills and social functionality.Study data were collected using a personal information form, the Functional Remission of General Schizophrenia Scale (FROGS) and the Scale for Assessing the Three Components of Insight (SAI). The data were analyzed on the basis of pre-intervention, post-intervention and 3 months after the intervention.
15740136|NCT04941339|Drug|MRG002|Administrated intravenously
15740137|NCT04941326|Other|Diaphragmatic stimulation treatment with PNF techniques|Thumbs and palms are placed along the cartilage edges of the lower ribs. At the end of the expiration, pressure and stretching are given as far into the chest and upwards as possible and a deep inspiration is requested immediately after the pressure. Both sides can be stimulated by repeated contraction technique. Hand holding positions may differ according to the patient's preference. If the patient's physical condition is not suitable, the application can be done with the thumbs, the thumb of the left hand for the right rib, and the thumb of the right hand for the left rib in the same lying position. The patient will be asked to do the application 2 times in a day with 10 repetitions for 4 weeks.
15740138|NCT04941326|Other|Costal mobilization|In the supine position, the individual will place both hands around the 10-12th ribs and alternately apply an oblique push from the right and left sides to the opposite side. The exercise will be taught to the patient as training, and he will be asked to apply it 2 times a day with 20 repetitions for 4 weeks.
15740139|NCT04941326|Other|Breathing exercises|It is done to increase the diaphragm activity of the individual and to suppress chest breathing. While lying in the supine position, the legs are placed in a hooked position, with one hand on the abdomen and the other on the chest, and the deep breath that is taken from the nose in 2 seconds is asked to exhale through the mouth in 4 seconds, while revealing as little movement in the chest as possible, the main movement is requested to be around the abdomen. The application will be given to the patient as a home program and he will be asked to do it 2 times a day with 5 repetitions for 4 weeks.
15740140|NCT04941326|Other|Spinal mobilization|T12 vertebrae will be found by following the 12th rib in the prone position of the individual and spinous of L1 and L2 vertebrae will be determined with this reference. Then, small amplitude rotational movements in the vertebrae will be revealed by pushing in the anterior direction over the transverse processes. This application will be applied once a week for an average of 10 minutes for 4 weeks.
15740141|NCT04941326|Other|Sham mobilization|Sham pressures will be applied to the lumbar region of the patient, away from the vertebrae. This application will be applied once a week for an average of 10 minutes for 4 weeks.
15740142|NCT04941313|Drug|3D229|3D229 is an investigational drug.
15740143|NCT04941313|Other|Placebo|Matching placebo
15740209|NCT04940741|Other|Placebo|comparator without active ingredient
15740327|NCT04939883|Drug|Placebo|Patients will receive placebo in a presumed staggered and progressive manner similar to the intervention group. The placebo will ideally be maintained for up to 30 days after the end of chemotherapy.
15740149|NCT04941274|Drug|Abemaciclib|An initial dose of 200 mg twice daily and at an MTD dose will be administered orally every day of each 28-day cycle.
15740150|NCT04941261|Biological|low-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine|Intramuscular injection of low-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine in the deltoid muscle of the upper arm
15740151|NCT04941261|Biological|high-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine|Intramuscular injection of high-dose Norovirus Bivalent (GI.1 / GII.4) Vaccine in the deltoid muscle of the upper arm
15740152|NCT04941261|Biological|placebo|Intramuscular injection of placebo in the deltoid muscle of the upper arm
15740153|NCT04941248|Device|total-body PET/CT(uEXPLORER , United Imaging Healthcare, China)|This prospective study will enroll sixteen patients, including three healthy volunteers, four patients with moderate or mild decreased EF values, and nine patients with aortic stenosis . All of them will have a whole-body PET/CT(uEXPLORER , United Imaging Healthcare, China) in our department, Renji Hospital.
15740154|NCT04941235|Device|ultrasound and nerve stimulator|nerve stimulator and ultrasound guided interscalene brachial plexus block
15740155|NCT04941222|Other|"With robotic seal PARO"|The PARO robot will be made available to the patient by the caregiver in charge of the patient for 5mn before a toilet and during the duration of the care (about 10mn), at the frequency of twice a week for 16 weeks
15740156|NCT04941209|Device|imPulse™ Una infrasound-to-ultrasound e-stethoscope|The imPulse™ System is an every/anywhere-point-of-care cardiopulmonary functional state assessment platform designed to capture normal and abnormal, audible and inaudible cardiopulmonary sounds, rhythms and patterns, via a real-time, intelligent, full-spectrum phonocardiogram obtained from direct to skin coupling or through a layer of clothing.
15740157|NCT04941209|Diagnostic Test|(PPA >95%) FDA EUA RT-PCR|Real-time RT-PCR that detects amplified SARS-CoV-2 genome in sputum, nasopharyngeal or oropharyngeal swabs, bronchoalveolar lavage fluid, nasal or nasopharyngeal aspirate, and lower respiratory tract aspirates.
15740158|NCT04941209|Radiation|HR-CT-scan|High-resolution computer tomography, or CT/CAT, is an X-ray scan that produces images of the chest and is used as a confirmatory test in symptomatic patients that have a negative PCR test.
15740159|NCT04941196|Drug|Anplag (Ticagrelor 90 mg)|Ticagrelor 90 mg Immediate Release tablet
15740160|NCT04941196|Drug|Brilinta (Ticagrelor 90 mg)|Ticagrelor 90 mg Immediate Release tablet
15740161|NCT04941183|Drug|NTR-441|NTR-441
15740162|NCT04941183|Drug|Placebo|Placebo
15740163|NCT04941170|Drug|Bupivacain|Ultrasound-guided oblique subcostal transversus abdominis plane block will be performed in the supine position under strict aseptic precautions. placing a linear high-frequency ultrasound probe obliquely near the costal margin and xiphoid process On confirming the placement of the needle in the correct target space, 1 mL of 0.25% bupivacaine will be injected to hydro-dissect the fascia layer between the RA and TA. After confirming the separation of the transversus abdominis fascia plane, the remaining 19 mL of 0.25% bupivacaine will be administered, advancing the needle infero-laterally parallel to the subcostal margin. A similar procedure will be performed on the contralateral side of the abdomen with an injection of another 20 mL of 0.25% bupivacaine.
15740164|NCT04941170|Drug|Bupivacaine|Ultrasound-guided erector spinae plane block will be performed in the sitting position. T7 spinous process will be located To perform the block. The tip of the T7 transverse process will be then identified using the ultrasound probe that is placed in a transverse orientation The ultrasound transducer will then be placed in a longitudinal orientation 2-3 cm lateral to the midline in a longitudinal orientation to identify the hyperechoic line of the transverse process with its associated acoustic shadow. After local anaesthetic infiltration, the block needle will be inserted in a craniocaudal direction until contact will be achieved with the T 7 transverse process where the tip will lay in the inter-fascial plane below the erector spinae muscle. A small bolus of local anaesthetic should be given through the block needle to confirm the proper needle position. A total of 20 mL bupivacaine 0.25% will be injected into the interfacial plane deep to the erector spinae muscle bilaterally.
15740165|NCT04941157|Procedure|Cerebrospinal Fluid Drain Placement|Prophylactic CSF Spinal Drain to be placed prior to surgery in patients randomized to the experimental arm of the study
15740166|NCT04941144|Biological|COVID-19 Vaccine|COVID-19 Vaccine Intramuscular Injection
15740167|NCT04941131|Drug|Chlorhexidine digluconate, povidone iodine|This is a mouth wash that can be used over the counter.
15740168|NCT04941118|Drug|Injection of dextrose, local anesthetic and saline to the myofascial trigger point|An injection of 5 ml of 5% dextrose prolotherapy using 2.5 ml 10% dextrose, 1 ml 2% local anesthetic (lidocaine), 1.5 ml 0.9% saline will be administered to the active group from at least 10 trigger points.
15740169|NCT04941118|Drug|Local anesthetic and saline injection to the myofascial trigger point|A total of 5 ml of solution created by using 4 ml of 0.9% saline and 1 ml of 2% local anesthetic (lidocaine) will be administered to the control group, with at least 10 trigger points.
15740170|NCT04941105|Drug|Evolocumab|A single subcutaneous administration of 140 mg evolocumab
15740171|NCT04941105|Drug|Saline solution|A single subcutaneous injection of 1ml of 0,9% saline solution
15740172|NCT04941092|Other|no intervention|no intervention, retrospective comparison
15740173|NCT04941079|Other|no intervention|no intervention
15740174|NCT04941066|Behavioral|Active neurofeedback|The session will be done on an individual basis. The active group will receive neurofeedback training from the rumination-related brain functional connectivity.
15740175|NCT04941066|Behavioral|Sham neurofeedback|The session will be done on an individual basis. The sham group will receive neurofeedback training from an artificially generated random feedback signal.
15740176|NCT04941053|Diagnostic Test|laboratory test|seroprevalnce
15740279|NCT04940169|Procedure|anterior cruciate ligament recontruction|Firstly graft is harvested with help of arthroscopy femoral and tibial tunnels created then graft placed into tunnels
15740179|NCT04941014|Behavioral|Light Physical Activity|The guidelines from Rapid Assessment of Physical Activity (RAPA) participants were asked to perform Leisure Walk for 35 minutes
15740180|NCT04941014|Behavioral|Moderate Physical Activity|The guidelines from Rapid Assessment of Physical Activity (RAPA) participants were asked to perform Brisk Walk for 30 minutes
15740181|NCT04941014|Behavioral|Vigourous Physical Activity|The guidelines from Rapid Assessment of Physical Activity (RAPA) participants were asked to perform jogging for 15 minutes
15740182|NCT04941001|Device|ReferID|The ReferID tool is a digital tool which can be used to facilitate a review of asthma in primary and secondary care (Accident and Emergency).
15740183|NCT04940988|Other|Real-time benefits check|Prescribers practicing in outpatient departments assigned to the intervention arm will be shown popup alerts with their patient's insurance benefit design-specific out-of-pocket cost for the drug being ordered as well as out-of-pocket costs for up to 3 lower-cost alternatives if available. Alternatives will only be shown when available and when the patient and his or her benefit design information can be matched by the electronic health record system to accurately query out-of-pocket cost information.
15740184|NCT04940975|Behavioral|Occupation-based sleep intervention program|A program composed of four occupation-based interactive workshops on sleep, insomnia, lifestyle, and change strategies, plus two individual coaching sessions on lifestyle and sleep hygiene.
15740185|NCT04940975|Behavioral|Insomnia Education Program at Integrated Mental Health Clinic (IMHC)|A program composed of four educational sessions on sleep and insomnia, plus relaxation training, plus two individual review sessions on sleep hygiene with participant.
15740186|NCT04940962|Procedure|Sampling of adipose tissue|Removal of less than 1 cm3 of adipose tissue during visceral surgery
15740187|NCT04940949|Drug|Lu AF90103|Lu AF90103 - powder for solution for infusion
15740188|NCT04940949|Drug|Placebo|Placebo - powder for solution for infusion
15740189|NCT04940936|Behavioral|A Patient Decision Aid|The Patient Decision Aid informs about the pros and cons of each option
15740190|NCT04940923|Diagnostic Test|MRI|"T2 weighted and DTI MRI images of brachial plexus and wrist. Quantitative sensory tests include warm and cold detection and pain thresholds, paradoxical heat sensation, mechanical detection thresholds, mechanical pain sensation and thresholds, wind up ratios, vibration thresholds and pressure pain thresholds.
~Clinical tests include standard neurological tests and test for heightened nerve mechanosensitivity.
~Blood serum to analyse inflammatory proteins. Questionnaires include neck disability index, painDETECT, PTSD8, pain catastrophising scale, eq-5D-5L, DASS 42 and global perceived recovery"
15740191|NCT04940910|Dietary Supplement|Black rice bran extract|2 times a day, 2 capsule for 1 time, after breakfast/dinner meal, for 8 week
15740192|NCT04940910|Dietary Supplement|Placebo|2 times a day, 2 capsule for 1 time, after breakfast/dinner meal, for 8 week
15740194|NCT04940884|Behavioral|Supervised exercise training|SET Participants underwent 24 sessions of moderate-intensity exercise training (MICT) at 70% maximum predicted heart rate for 30 min in each session
15740195|NCT04940884|Behavioral|Aerobic exercise training|All recruited subjects were instructed to walk >=8000 steps per day in the community. Part of the participants were randomly assigned to underwent additional 24 sessions of supervised aerobic exercise training (SET) with the intensity at 70% of maximum predicted heart rate and the remaining participants follow the above home exercise training (HET) instruction without additional supervised exercise training.
15740196|NCT04940871|Drug|Favipiravir HU 200 mg hard capsules|Drug substance: Favipiravir Dose: 200 mg Administration: oral Formulation: capsules
15740197|NCT04940871|Drug|Placebo HU|Name: Placebo clinical sample Drug substance: placebo Dose: - Administration: oral Formulation: capsules
15740198|NCT04940845|Drug|HS-20090-2|Subcutaneously injection of HS-20090-2 (60mg/1mL) once on the first day
15740199|NCT04940845|Drug|Prolia|Subcutaneously injection of Prolia® (60mg/1mL) once on the first day
15740200|NCT04940832|Device|pulsed radiofrequency modulation|a percutaneous needle electrode to apply pulsed RF signals that modulate the activity of sensory nerves. The pulsing of the RF signal permits a maximum temperature to be achieved - usually 42 Celsius. This helps prevent collateral damage from occurring during the procedure and should help reduce procedural complications.
15740201|NCT04940819|Behavioral|Mobile Application for Dietary Management|A mobile application developed by a multi-disciplinary team will be used in the dietary management of CKD patients. The application is patient orientated. It has 4 core features including food searching, dietary logging, personalized key nutrient intake feedback and patient-caregiver interaction.
15740202|NCT04940793|Device|POD FT|Cataract surgery
15740203|NCT04940780|Other|Acupuncture|Acupuncture points will be selected on an individualized and symptom-directed basis, with the incorporation of points shown in clinical research to be effective for specific symptoms
15740204|NCT04940780|Other|Touch Therapies|Touch therapies are to include Reflexology, Shiatsu and Therapeutic Touch
15740205|NCT04940767|Drug|Isotretinoin|Isotretinoin is a retinoic acid analogue (13-cis-retinoic acid) supplied as oral capsules. and was approved in the US for the treatment of severe acne vulgaris in 1982 under the brand name Accutane®.
15740206|NCT04940767|Drug|Amzeeq 4% Topical Foam|AMZEEQ® is a topical lipophilic foam containing 4% minocycline that was approved in the US for the treatment of acne vulgaris in 2019
15740210|NCT04940728|Other|Creative thinking techniques intervention program|The intervention program based on creative thinking techniques was designed to consist of four stages: preparation, theoretical briefing, skill development and evaluation. In the first stage of the program, acquaintance and information meeting, in the second stage, the theoretical part lasts for two weeks, in the third stage, various creative thinking techniques are applied for four weeks to gain creative thinking skills.
15740211|NCT04940715|Other|Passive joint mobilization|Dosage: 5 sets of 2 minutes with 30 seconds of rest were applied, with a strong force (>50% of maximum therapist strength), according to patient's irritability and severity.
15740212|NCT04940715|Other|Mobilization with movement|Dosage: 3 sets of 10 repetitions were performed, with 1-2 minutes of rest between sets.
15740213|NCT04940702|Other|Focal Vibration|"Training with Focal Vibration on rectus anterior, vastus medialis and vastus lateralis muscles with an intensity of 120 Hz and an amplitude of 1.2 mm. Time of training 20-25 min.
~The exercise is the same than traditional training group."
15740214|NCT04940702|Other|Blood Flow Restriction|Training with Blood Flow Restriction, the restriction is in the proximal part of the lower limb. The exercise is the same than traditional training group.
15740215|NCT04940702|Other|Traditional Training|Warm up, aerobic training, stenght training, balance and coordination training and return to calm
15740216|NCT04940689|Drug|Dexmédétomidine 0.5 g/kg + lidocaine 1.5 mg/kg|The patient will be anesthetized with Dexmedetomidine 0.5 g / kg + lidocaine 1.5 mg / kg for the induction instead of morphin.
15740217|NCT04940689|Drug|Remifentanil|The patient will be anesthetized with morphin.
15740218|NCT04940676|Drug|Huzhangxiefei Decoction|Huzhangxiefei Decoction, 50ml, Oral Administered or Nasal Feeding 5 minutes after breakfast and dinner for 7 days
15740219|NCT04940676|Drug|10% Huzhangxiefei Decoction|10% Huzhangxiefei Decoction, 50ml, Oral Administered or Nasal Feeding 5 minutes after breakfast and dinner for 7 days
15740220|NCT04940663|Behavioral|EMA|Participants will complete surveys about their feelings and social habits through a smartphone app (EMA)
15740221|NCT04940650|Diagnostic Test|exercise testing|To define the strenuous physical exercise in this study, each participant will be asked to perform at least two hours of high intensity (HIT)-effort during the endurance exercise of at least 6 to 7 hours. Therefore all participants will have exercise testing approximately 1 week before the physical exercise to set aerobic and anaerobic gas exchange thresholds, as well as VO2max.
15740222|NCT04940650|Diagnostic Test|Echocardiography|Measurements of mass, volumes and function will be obtained of both the left and right ventricles at rest enabling comparisons with cardiac MRI and traditional echo measures.
15740223|NCT04940637|Drug|niraparib and dostarlimab|niraparib 300 mg/die and dostarlimab 500 mg day 1 Q3 weeks for the first 4 cycles followed by 1000 mg day 1 Q6 weeks
15740226|NCT04940598|Other|high intensity interval exercise|HIIT training will be delivered two times per week for 16 weeks (32 sessions). Each session will be separated by at least 24-hrs. Participants will be allowed to choose the days and times that they feel exercise will fit into their schedule. The HIIT protocol will be determined based on peak anaerobic power measures during an arm crank Wingate Cycle test. HIIT will consist of 20 minutes of exercise consisting of four minutes of arm crank exercise at 5% of peak anaerobic power followed by 30 seconds at 30% of the peak anaerobic power; this cycle will be repeated four times, ending with two minutes of recovery at 5% of peak anaerobic power.
15740227|NCT04940598|Other|No-exercise control group|No-exercise control group
15740228|NCT04940585|Other|ROSE Program|The program includes 6 group sessions and an individual session 4-6 weeks after birth. Each session will last 60 minutes and will be conducted over Webex. The key areas that will be discussed during the sessions include: Psychoeducation, Adjusting to life with baby, Effective communication, Asking for what you need, and Planning for the future.
15740229|NCT04940572|Drug|Depakine|Refer to arm description.
15740230|NCT04940559|Drug|Danicopan - Tablet|Oral tablet.
15740231|NCT04940559|Drug|Danicopan - Softgel|Oral softgel capsule.
15740232|NCT04940559|Drug|Danicopan - LFC|Oral LFC.
15740233|NCT04940546|Drug|Sintilimab|Mode of administration: Intravenously
15740234|NCT04940546|Drug|Oxaliplatin|Mode of administration: Intravenously
15740235|NCT04940546|Drug|Capecitabine|Mode of administration: Orally
15740236|NCT04940546|Drug|Bevacizumab|Mode of administration: Intravenously
15740237|NCT04940520|Biological|Drug recommended by the Brazilian Society of Dermatology|Using a drug recommended by the Brazilian Society of Dermatology, twice a day.
15740238|NCT04940520|Combination Product|Alpha bisabolol product and laser|Using alpha bisabolol-based product associated with low-level laser therapy. Alpha bisabolol-based product will be used twice a day, and laser therapy used once every fortnight.
15740239|NCT04940520|Biological|Alpha bisabolol product|Using alpha bisabolol-based product twice a day
15740240|NCT04940507|Procedure|Magnetic Resonance Guided Focused Ultrasound Tumor Ablation and Liquid Biopsy Acquisition|Partial ablation of tumor using ExAblate Neuro 4000 device (InSightec Ltd, Tirat Carmel, Israel) and blood and CSF draws for liquid biopsy
15740241|NCT04940507|Procedure|Magnetic Resonance Guided Focused Ultrasound Thalamotomy|Ablation of VIM nucleus of thalamus with MRgFUS using ExAblate Neuro 4000 Device (InSightec Ltd, Tirat Carmel, Israel) and blood draws.
15740242|NCT04940494|Other|collection of data|collection of data for all Obstetrical Anal Sphincter Injury women (score of quality of life, experimenting anal incontinence...)
15740243|NCT04940468|Other|Diet Intervention|The dietary fiber intake target will be 19 g/d for ages 9-18 and females age 19 and older and 23g/d for males age 19 and older.
15740244|NCT04940455|Other|Educational digital platforms|The digital educational platforms will be implemented through games of questions and answers, simulated cases sent via google forms about the nurse's performance in a critical care unit facing the patient with signs and symptoms of sepsis. The questions in the games will aim to develop clinical judgment and quick decision-making in nursing students in order not to compromise the health care of the patient in sepsis.
15740245|NCT04940442|Behavioral|Outreach|Active: Outreach offering FIT or colonoscopy. Sequential: Outreach offering FIT first, and then offering colonoscopy to those still unscreened
15740328|NCT04939870|Diagnostic Test|Biochemical parameters evaluation|selected biochemical parameters
15740246|NCT04940429|Device|Neurofit|This involves sitting on a chair with a head and chin rest to maintain stability. Patients will then follow a moving object on the computer screen with their eyes which allows estimation of individual oculometrics along with a composite score. No physical contact or placement of invasive devices will be performed.
15740247|NCT04940429|Diagnostic Test|Psychometric hepatic encephalopathy score|During the number connection tests, the participant is asked to join dots between numbers or numbers and letters in a timed fashion and the number of seconds required is the outcome. In the line tracing test, participants are required to trace a line between two parallel lines and the time required is noted. Also, the number of times the subject strays outside the line (line tracing test error) is captured. In the digit symbol test, participants are required to pair numbers with special symbols. An individual's score reflects the number of correct pairs achieved in 120 seconds. In the serial dotting test, participants are asked to dot the center of a group of blank circles and the time required to complete the test is the outcome. Psychometric tests will be completed at their post-operative visits.
15740248|NCT04940416|Device|Neurofit (oculometric testing)|The Neurofit test involves sitting on a chair with a head and chin rest to maintain stability. Patients will then follow a moving object on the computer screen with their eyes which allows estimation of individual oculometrics along with a composite score. No physical contact or placement of invasive devices will be performed. The total time for completion of all the tests is estimated at 30 minutes.
15740249|NCT04940403|Device|Burt|18 one-hour sessions of unimanual upper-limb tasks during robot-assisted training with the Burt.
15740250|NCT04940403|Device|Burt + BurtVision|18 one-hour sessions of combination of unimanual and bimanual upper-limb tasks during robot-assisted training with the BurtVision.
15740251|NCT04940390|Drug|Dihydroergotamine|Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
15740252|NCT04940390|Drug|Placebo|Placebo for STS101
15740253|NCT04940364|Drug|Pozelimab|Administered intravenous (IV) or subcutaneous (SC) per protocol
15740254|NCT04940364|Drug|Cemdisiran|Administered SC per protocol
15740255|NCT04940351|Procedure|GROUP - A: PIEZOCISION GROUP|This group will receive piezocisions after placement of initial arch wire, in between the roots of mandibular anteriors (in a vertical line) i.e., between mandibular canine and lateral incisors bilaterally, lateral incisors and central incisors bilaterally and between two cental incisors with the help of piezotome. These piezocisions will be performed on the labial cortical bone only, 4mm below the interdental papilla under 2% lidocaine with 1:100,000 epinephrine and with standard asepsis, and gingival overlying will be incised first with blade number 15 in a Bard Parker handle. A piezosurgical microsaw with piezosurgical drill will be placed over that incision with irrigation. Then, vertical 5- to 8-mm and 3mm deep corticotomies will be perform using periapical radiographs as a guide to avoid penetrating into the adjacent roots. No subsequent sutures required.
15740256|NCT04940351|Procedure|GROUP- B: MICRO-OSTEOPERFORATION GROUP|This group will receive MOPs after initial arch wire placement. These MOPs will be performed under local anesthesia with standard asepsis, using a self drilling 1.6mm x 8mm orthodontic mini-implants and mini-implant screw driver and no flap will be raised. MOP's will be placed on three sites i.e., interproximally between mandibular canine and lateral incisors bilaterally and between two central incisors. Each site will receive two MOP's, first 2mm apical to alveolar crest and second 2mm below the first in a vertical line and 2mm deep into the bone. Then the mini-implant will be removed by rotating the screw driver anticlockwise and pressure will be applied to achieve hemostasis.
15740257|NCT04940338|Drug|Bromfenac Ophthalmic 0.09% Ophthalmic Solution|topical bromfenac (0.9 mg/mL) 2x daily 7 days before the surgery
15740258|NCT04940338|Drug|Dexamethasone Ophthalmic|topical dexamethasone (1 mg/mL) 3x daily 7 days before the surgery
15740259|NCT04940338|Drug|Placebo|topical placebo (artificial tears substitute) 2x daily before the surgery
15740260|NCT04940338|Procedure|Phacoemulsification surgery (PHACO)|About 0.1-0.2 mL of aqueous humor will be collected at the beginning of the cataract surgery (PHACO) through paracentesis, aqueous will then be transported in dry ice with a dedicated box to the laboratory and stored at -80C until the analysis. IL6 concentration will be analyzed with Human IL6 Quantikine Elisa kit (R&D System).
15740261|NCT04940325|Drug|DS-1062a|First infusion for 90 minutes and then infusion duration can be decreased to 30 minutes if participant didn't experience infusion related reactions (IRR)
15740262|NCT04940312|Behavioral|App-based physical activity coaching|Individualized app-based coaching via a smartphone
15740263|NCT04940299|Biological|Ipilimumab|Given IV
15740264|NCT04940299|Biological|Nivolumab|Given IV
15740265|NCT04940299|Biological|Tocilizumab|Given SC
15740266|NCT04940286|Biological|Durvalumab|Given IV
15740267|NCT04940286|Drug|Gemcitabine|Given IV
15740268|NCT04940286|Drug|Nab-paclitaxel|Given IV
15740269|NCT04940286|Biological|Oleclumab|Given IV
15740270|NCT04940273|Drug|Remifentanil Injection [Ultiva]|Continuous infusion of remifentanil at a dose of 0.02、0.04、0.06、0.08 ug/kg/min for 30 minutes in sequence.
15740271|NCT04940260|Diagnostic Test|Renal function|measure eGFR at one year post partum
15740272|NCT04940260|Diagnostic Test|proteinuria|measure urine protein creatinine ratio at one year postpartum
15740273|NCT04940234|Behavioral|Exposure to a Photo|We plan to recruit subjects and randomly assign them to one of four treatments. In each treatment arm, the subject will view a photo of a man. We experimentally vary treatment along two dimensions: whether the man is wearing expert vs. layperson attire and whether the man is white vs. black. We will survey participants' beliefs about the actors' educational attainment and perceived quality as measured by subjects' willingness to accept medical advice for non-urgent health issues or participate in a clinical trial being led by the individual in the photo.
15740274|NCT04940221|Behavioral|Shared Decision Making|Telephone delivered non-persuasive shared decision-making for lung cancer screening.
15740275|NCT04940208|Other|Pain and neuropsychological questionnaires|Patient-reported outcomes, listed in the Secondary Outcome Measure Section
15740276|NCT04940208|Diagnostic Test|Quantitative Sensory testing|Summation pain threshold test and Heat pain threshold skin test
15740277|NCT04940182|Drug|XC221|Participants will receive XC221 100 mg 2 times a day during 14 full days
15740278|NCT04940182|Drug|Placebo|Participants will receive Placebo 2 times a day during 14 full days
15740329|NCT04939857|Drug|Trimetazidine|The experimental group will be treated with trimetazidine, and the control group will not be intervened
15740282|NCT04940143|Drug|Botulinum toxin type-A (Onabotulinum toxin type-A)|Botulinum toxin-A (Onabotulinum toxin type-A/Botox®) injection will be administered from three different points, two on the medial head of the gastrocnemius muscle and one point on the lateral head with total 3-6 units/kg dose, under the guidance of electrical stimulation for the detection of the target neuromuscular junction.
15740283|NCT04940143|Other|Physical Therapy|After the botulinum toxin-A injection, the patients will be included in the comprehensive physiotherapy program thrice a week for a total of 12 weeks. The physiotherapy program will be consisted of the ankle range of motion and stretching, strengthening of the antagonist muscles, proprioception exercises, functional walking training and static and dynamic balance training.
15740284|NCT04940130|Biological|Sanaria® PfSPZ Vaccine|non-adjuvanted, live (metabolically active), radiation-attenuated, non-replicating, whole sporozoite (SPZ) vaccine designed to prevent malaria infection caused by Plasmodium falciparum (Pf).
15740285|NCT04940130|Other|Normal Saline|placebo control- saline
15740286|NCT04940117|Dietary Supplement|Eefooton oral solution|Check eGFR value, liver and kidney function every month
15740287|NCT04940104|Drug|Botox Injectable Product|Botox is a well known neurotoxin that is derived from the bacterium clostridium botulinium. Its therapeutic applications are variable and well documented, alongside its cosmetic applications. There are seven known serotypes of Botox, from A to G, but only two types; A &B, are available for medical and cosmetic uses.
15740288|NCT04940091|Drug|Epidural analgesia|Epidural analgesia is performed with a mixture of local anesthetics (ropivacaine) and opioids (sufentanil).
15740289|NCT04940078|Drug|Cagrilintide|Once weekly doses of cagrilintide gradually increased to 1.7 mg over 14 weeks and 2.4 mg s.c. for 2 weeks
15740290|NCT04940078|Drug|semaglutide|Once weekly doses of semaglutide gradually increased to 1.7 mg over 14 weeks and 2.4 mg s.c. over 2 weeks
15740291|NCT04940078|Drug|Cagrilintide and semaglutide|Cagrilintide and semaglutide combined and administered using the DV3384 manual syringe
15740293|NCT04940052|Drug|Dabrafenib|Dabrafenib will be administered orally twice daily
15740294|NCT04940052|Drug|Trametinib|Trametinib will be administered orally once daily
15740295|NCT04940052|Drug|Trametinib placebo|Trametinib will be administered orally once daily
15740296|NCT04940052|Drug|Dabrafenib placebo|Dabrafenib placebo will be administered orally twice daily
15740306|NCT04940026|Drug|amcenestrant|Tablet Oral
15740307|NCT04940026|Drug|[14C]-SAR439859 microtracer|Solution for infusion Intravenous
15740308|NCT04940026|Drug|[14C]-SAR439859|Powder for oral solution Oral
15740309|NCT04940013|Drug|Misoprostol|Study participants are given misoprostol alone for menstrual regulation.
15740310|NCT04940000|Other|Patient managed at the IUCT-O and by a private speech therapist (near the patient's home).|"Each patient included will have a video-assisted remote speech therapy consultation with a private speech therapist (near the patient's home) and the expert speech therapist of IUCT-O center.
~At the end of this video consultation, the patient and the private speech therapist will be asked to complete a satisfaction questionnaire."
15740319|NCT04939974|Dietary Supplement|probiotic|The probiotic preparation selected for this study will contain use three species of probiotic bacterias namely Lactobacillus rhamnosus - ATCC 21052, Lactobacillus plantarum - ATCC 8014 and Bifidobacterium longum subsp. Infantis-ATCC 15707 at the dose of one billion (10 9 ) CFU/g of product (Total 3x10 9 CFU/g).
15740320|NCT04939961|Dietary Supplement|Hericium erinaceus|6 capsules per day, 3 times two after breakfast, lunch and dinner
15740321|NCT04939961|Dietary Supplement|Placebo|6 capsules per day, 3 times two after breakfast, lunch and dinner
15740322|NCT04939935|Drug|Metformin XR|Extended release metformin.
15740323|NCT04939935|Other|Control|Placebo is inactive tablets that is identical to the intervention Metformin tablets.
15740324|NCT04939909|Drug|Botulinum toxin type A|Patients were treated with Botulinum toxin type A applications on the Orbicularis oculi and glabellar complex
15740325|NCT04939896|Other|observation|Observed patients' compliance with rehabilitation at different time
15740326|NCT04939883|Drug|Carvedilol|Carvedilol will be dispensed in a staggered and progressive manner, initially from 6.25 mg twice daily, then increased to 12.5 mg twice daily, until maximum dose of 25 mg twice daily or development of contraindications
15740330|NCT04939844|Drug|Isatuximab, bortezomib, lenalidomide, dexamethason|All participants will receive the same treatment as described under arm.
15740331|NCT04939831|Other|Total Laparoscopic or Robotic Radical Hysterectomy|Radical hysterectomy with bilateral pelvic lymph node dissection is performed as standard type C RH by Q-M classification, including cardinal ligaments divided at pelvic sidewall and uterosacral ligaments divided at near the sacral origin and the upper 1/4 to 1/3 of the vagina.
15740332|NCT04939831|Other|Total Abdominal Radical Hysterectomy|Radical hysterectomy with bilateral pelvic lymph node dissection is performed as standard type C RH by Q-M classification, including cardinal ligaments divided at pelvic sidewall and uterosacral ligaments divided at near the sacral origin and the upper 1/4 to 1/3 of the vagina.
15740333|NCT04939805|Device|Selective CRP apheresis using the PentraSorb®-CRP system|Selective CRP apheresis as an adjunct to standard of care. Apheresis using the PentraSorb®-CRP system will be performed at day 1, 2 and 3 after PCI.
15740334|NCT04939792|Drug|Vitamin D|Capsules ingested orally
15740335|NCT04939792|Drug|Placebo|Capsule ingested orally
15740336|NCT04939792|Drug|Vitamin D + L-cysteine|Capsule ingested orally
15740337|NCT04939792|Drug|L-cysteine|Capsule ingested orally
15740338|NCT04939779|Drug|LCB01-0371 tablet 400mg (Test drug, Batch# 3183817R)|Oral administration
15740339|NCT04939779|Drug|LCB01-0371 tablet 400mg (Reference drug, Batch# 1650006)|Oral administration
15740340|NCT04939766|Device|Activation of a closed loop device in an insulin pump device with GCM|After a run-in period of 20 days to co,firm eligibility, the closed loop is activated and patients are followed for 6 months by their diabetologists.
15740341|NCT04939753|Drug|Sevoflurane|Sevoflurane administration to sedate the patient
15740342|NCT04939727|Other|OUD-CDS + Suicide Risk Model associated CDS|Access to OUD-CDS + Suicide Risk CDS
15740343|NCT04939714|Behavioral|Psychoeducational Intervention|The intervention is an online course providing education and training to caregivers over an 8 week period. The self-paced course provides information on caregiving for a PLWD during a pandemic, navigating the health care system for a PLWD, and managing daily life (including self-care).
15740344|NCT04939701|Drug|ASP0739|Intravenous (IV)
15740345|NCT04939701|Drug|Pembrolizumab|Intravenous (IV)
15740346|NCT04939688|Radiation|Conventional dose AND ultra low-dose CT scanning in the search for cranial lesions|As well as undergoing the usual, conventional radiation dose CT scan, these patients will also undergo ultra low-dose CT scanning in the search for cranial lesions.
15740347|NCT04939675|Drug|Zonisamide 100mg|Only one ASM will be used. The drug choice depends on patients tolerance and basic condition. Twice daily
15740348|NCT04939675|Drug|Levetiracetam 500mg|Only one ASM will be used. The drug choice depends on patients tolerance and basic condition. Twice daily
15740349|NCT04939675|Drug|LamoTRIgine 50mg|Only one ASM will be used. The drug choice depends on patients tolerance and basic condition. Twice daily
15740350|NCT04939662|Drug|Olaparib+Bevacizumab to SCLC patients|"Olaparib 300 mg bid per os every 12 hours D1-21 administered in each cycle days. One cycle consists of 21 days.
~Bevacizumab 15 mg/kg via IV administered on Day1 of each cycle. One cycle is consisted of 21 days.
~The subject's body weight criterion is based on C1D1 (first dose date), and if more than 10% of BW is increased and decreased, the drug dose is changed to that BW."
15740351|NCT04939649|Drug|Ketamine|A sub-anaesthetic dose of ketamine will be administered for up to a four-week course of twice-weekly infusions.
15740352|NCT04939649|Drug|Midazolam|A sub-anaesthetic dose of midazolam will be administered for up to a four-week course of twice-weekly infusions.
15740353|NCT04939636|Dietary Supplement|Vitamin D3 capsules 4000IU/100µg.|Vitamin D3 supplementation
15740354|NCT04939636|Dietary Supplement|Vitamin D3 capsules 600IU/15µg.|Vitamin D3 supplementation
15740355|NCT04939623|Drug|Probenecid|The Investigators aim to recruit 40 participants who will be followed for 12 weeks in duration. Participants will be randomized in a 2:2:1 ratio to one of probenecid 500 mg, 1000 mg, or placebo PO BID for 12 weeks. Justification for use of a non-active placebo comparator includes the fact that this trial is meant to identify tolerability and safety of probenecid in a population of patients living with chronic pain, this will be best measured by comparing to a non-active placebo.
15740356|NCT04939610|Drug|68Ga-FAP-2286|68Ga-FAP-2286 IV administered as imaging agent for PET scan.
15740357|NCT04939610|Drug|177Lu-FAP-2286|Patients with positive uptake of 68Ga-FAP-2286 will receive a fixed dose of 177Lu-FAP-2286 IV administered every 6 weeks for a maximum of 6 doses. Doses range between 3.7 and 9.25 GBq (100-250 mCi).
15740358|NCT04939610|Drug|177Lu-FAP-2286|Patients with positive uptake of 68Ga FAP 2286 will receive a fixed dose of 177Lu FAP 2286 IV administered at the RP2D and schedule determined in Phase 1 dose escalation.
15740359|NCT04939597|Procedure|Cognitive Assessment|Complete cognitive testing
15740360|NCT04939597|Drug|Memantine Hydrochloride|Given PO
15740361|NCT04939597|Drug|Placebo Administration|Given PO
15740362|NCT04939584|Device|MultiPulse Therapy|Electrical Stimulation
15740363|NCT04939571|Other|Registry of preterm born infants with treatment-requiring ROP|All prematurely born infants who develop treatment requiring ROP and are treated (independent of the kind of treatment modality) at a center that participates in the registry are eligible for database entry.
15740364|NCT04939558|Device|N-Tidal C handset|Participants are to use the 'N-Tidal C' handset every day for 14 days. This will ideally be two times a day (once in the morning and once in the evening, before using any regular inhalers). Each breath record requires the participant to breathe through the mouthpiece for 75 seconds in a relaxed manner.
15740386|NCT04939389|Diagnostic Test|Orthelligent Pro|The sensor is attached to the knee of the participant and eight different movement exercises are performed
15740387|NCT04939376|Procedure|IVF|In vitro fertilization
15740367|NCT04939532|Behavioral|Text-Messaging (TM)|"Patients in the TM condition will receive HIPAA-compliant bidirectional text messages. Texts will include a brief message regarding COVID-19 risk and will screen the participants for COVID symptoms or close contact. Participants who reply yes to symptoms or exposure will receive additional messages with a recommendation to be tested, testing locations/hours/phone, and resources about what to do if they test positive. Patients who reply no will receive a text with the clinic phone number and a note to call if anything changes."
15740368|NCT04939532|Behavioral|Patient Navigation (PN)|Patients in the PN condition, who respond YES to symptoms, exposure, or contact, will receive a notice via text message that a Community Health Worker will contact them for patient navigation. At this time, patients will will have the option to opt-out of the phone call from the patient navigator. The Patient Navigation includes advice from navigators to address practical barriers to COVID testing such as logistics, transportation, and expenses as well as behavioral barriers such as hesitancy, fear, and uncertainty.
15740369|NCT04939519|Behavioral|Text-Messaging (TM)|"Participants in the TM condition will receive HIPAA-compliant bidirectional text messages. These texts will include a brief message alerting patients that they are eligible to receive the vaccine and asking participants if they would like to schedule a vaccine. Participants who reply yes will receive an additional message with information about how and where to register for the vaccine. This information will vary depending on local availability. Participants who reply no will receive a text requesting they contact their local clinic when they decide to receive the vaccine."
15740370|NCT04939519|Behavioral|Patient Navigation (PN)|Participants in the PN condition will receive a message alerting them that a Community Health Worker will contact them to assist with the process of scheduling a vaccine. At this time the participant has the option to opt-out of this follow up phone call. The patient navigation from the Community Health Worker includes practical advice in addressing barriers to vaccination such as logistics and transportation, as well as fear, skepticism, and hesitancy.
15740371|NCT04939506|Behavioral|COVID-19 Vaccine Education at the Point of COVID-19 Testing|A rapid vaccination education model to be delivered at the point of COVID-19 testing by pharmacy students, pharmacy technicians, nurse's aides and other health care personnel. The intervention will include: 1) 15 minute vaccine counseling, 2) print material 3) referral to a dedicated vaccine website with feedback forums and 4) opportunity to sign-up for one-on-one vaccine counseling with a clinical pharmacist
15740372|NCT04939493|Other|Rhythmic Auditory Cueing|"Patients will perform the same movement sequence in time with the metronome beat. The frequency of the rhythmic auditory stimulation will be matched to the participants preferred movement speed, which will be assessed prior to the start of the trial, and participants typically started moving after they had heard the metronome beat two to three times. Participants will be given sufficient practice trials to ensure full understanding before the actual recording of data, and will be given 3-minutes break between trials.
~On the 3rd and 5th week, the rhythm frequency was increased by 5%."
15740373|NCT04939493|Other|Bilateral arm training|Training will consist of 20 minutes of bilateral arm training In each session, patients will be seated comfortably at a table in the following limb positions: ankles in neutral dorsiflexion, knees and hips placed at 90°, shoulders in 0° flexion, elbows in 60° flexion, and wrists in neutral position of flexion/extension
15740374|NCT04939493|Other|Conventional physical therapy program|Scapular mobilization. Thoracic spine mobilization. Mechanical assisted (active and passive) exercises. Therapeutic positioning as weight bearing on the paretic arm. Opening and closing closed fist. Strengthening exercise. Stretching of spastic muscles.
15740375|NCT04939480|Drug|Atezolizumab|Atezolizumab 1200 mg intravenous solution
15740379|NCT04939454|Procedure|quadricipital biopsy|The primary endpoint will be evaluated by histological examination only. The technique of percutaneous biopsy using the modified Bergström needle technique is currently considered the best alternative in the context of research, as it allows sufficient material to be obtained for various analyses and is much less invasive than the reference technique (surgical biopsy). Indeed, unlike surgical biopsy which requires an operating room and is a relatively heavy procedure (two suture planes, skin incision of several centimeters, resting for 48 hours after the procedure...), percutaneous biopsy by the modified Bergström technique can be performed in a consultation room, requires only one stitch, and allows resumption of walking 30 minutes after the end of the procedure.
15740380|NCT04939441|Drug|Tenofovir alafenamide|Subjects will be treated for 96 weeks with TAF [Vemlidy® 25mg QD] monotherapy
15740383|NCT04939415|Drug|mQFPD|The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
15740384|NCT04939415|Drug|organic brown rice|The dosage of mQFPD is 8 capsules three times a day for 14 consecutive days. It does not need to be consumed with food. It is best taken at least 30 minutes before OR at least 60 minutes after meals, in the morning, noon and evening. Accidentally missed doses will not need to be taken at a later time but will be recorded in a daily diary.
15740385|NCT04939402|Diagnostic Test|Serological testing|Antibody testing for Sars-CoV-2 specific antibodies in blood + T cell immunity
15762519|NCT04756492|Drug|sandimmun|follow up for treatment response
15740388|NCT04939363|Combination Product|Obinutuzumab with Ibrutinib and Venetoclax|"Obinutuzumab intravenous infusion:
~Ibrutinib PO 560mg daily starting on cycle 1 day 1 for 12 cycles.
~Venetoclax with an accelerated ramp-up and close inpatient Tumor Lysis Syndromes (TLS) monitoring starts on cycle 1 day 15 to the target dose of 400mg daily for a total of 12 cycles:"
15740389|NCT04939350|Other|questionnaire|patients will complete a vaccination questionnaire
15740390|NCT04939337|Drug|TH-SC01|Allogeneic Umbilical Cord-derived Mesenchymal Stem cells perilesional injection. Human TH-SC01 cell injection (human umbilical cord mesenchymal stem cells for injection, 5 million cells / ml, 6.0-10.0ml / bottle)
15740391|NCT04939324|Biological|Blood samples at 2 sites: peripheral vein and tumor-draining vein|"D0: surgery (inclusion): oncological lung resection
~Blood samples at 2 sites: peripheral vein and tumor-draining vein
~Resected tumor analysis Standard clinical and radiological follow-up during 2 years (medical consultation or phone call)"
15740392|NCT04939311|Drug|VB-201|One dose of VB-201 80 mg (1 tablet) will be administered orally once daily for 52 weeks.
15740393|NCT04939311|Drug|Placebo|One dose of placebo 80 mg (1 tablet) will be administered orally once daily for 52 weeks.
15740394|NCT04939298|Device|Ultrasound|Ultrasound evaluation of the variation of thickness of abdominal muscles after 7 days of mechanical ventilation.
15740395|NCT04939285|Procedure|PEEP|The patients who met the withdrawal screening criteria were randomly divided into low pressure support level PSV spontaneous respiration test.The duration of the spontaneous breathing test was 30 minutes, and the results of the spontaneous breathing test were evaluated at the end of the test.
15740396|NCT04939272|Drug|Copanlisib Hydrochloride|"Patients receive copanlisib hydrochloride IV over 1 hour on days 1, 8, and 15 for each cycle.
~Copanlisib will be given at 30mg, 45mg, or 60 mg depending on the assigned dose level."
15740397|NCT04939272|Drug|Venetoclax|Patients receive venetoclax PO QD on days 1-28 for each cycle. Venetoclax will have a weekly dose ramp up in cycle one from 20mg, 50mg, 100mg, 200mg, and then 400mg daily thereafter starting from cycle 2.
15740398|NCT04939259|Device|New Music Program|A mini behind-the-ear hearing aid that amplifies sounds and directs them into the ear. The music program within the hearing aid will provide amplification specifically tuned for listening to music.
15740399|NCT04939259|Device|Standard Listening Program|A mini receiver-in-the-ear hearing aid that amplifies sounds and directs them into the ear. The standard listening program within the hearing aid will provide amplification specifically tuned for listening to speech and daily general sounds in the environment.
15740400|NCT04939246|Radiation|Stereotactic ablative body radiation therapy|Single-fraction of stereotactic ablative body radiation (SABR) therapy will be delivered with an integrated magnetic resonance imaging (MRI)-guided radiotherapy delivery system (ViewRay MRIdian Linac). The prescription dose is dependent on the anatomic location of the lesion and based on previously published safety data.
15740401|NCT04939233|Device|Exoskeleton glove|A robotic hand orthosis (exoskeleton glove) will have been developed that is able to naturalistically bend the finger joints of the individuals based on intuitive voice commands
15740402|NCT04939220|Procedure|TEE with SGA|SGA Placement and maintenance with inhalational anesthetic or propofol
15740403|NCT04939220|Procedure|TEE with Deep Sedation|Deep sedation with propofol and natural airway
15740404|NCT04939207|Diagnostic Test|CT-FFR|CT-images will be processed by an algorithm to calculate FFR-values of the full coronary tree
15740405|NCT04939207|Diagnostic Test|Angiography-derived FFR|FFR-values are calculated during coronary angiography based on the acquired images of the coronary arteries
15740406|NCT04939207|Diagnostic Test|Angiography with invasive FFR-measurements|during coronary angiography, a specialized pressure wire is passed through the coronary stenosis to calculate FFR based on the difference between the actual pressure and the expected pressure in the hypothetical healthy coronary artery.
15740407|NCT04939194|Behavioral|Fast Track Protocol|We will apply 22 items of ERAS society
15740408|NCT04939181|Device|Non-invasive Neuromodulation|"The electrodes will be placed with the help of gloves and adapted socks for 1 hour, twice a week, until 10 intervention sessions are completed. In addition, depending on the session, an adhesive electrode will be placed at the level of C7. Characteristics of microcurrents:
~pulsed monophasic rectangular wave with a pulse of 1.3 s and pause of 300 ms, voltage 3 mV and intensity 0.5 μA."
15740409|NCT04939181|Device|Placebo Non-invasive Neuromodulation|The same protocol described for the experimental group will be applied, but microcurrents device which will be previously manipulated and tested with an oscilloscope so that they do not emit electrical currents.
15740410|NCT04939155|Biological|SARS-CoV-2 mRNA vaccine|mRNA vaccine for COVID
15740411|NCT04939142|Drug|ATG-010|"Randomized into two treatment Arms in a 2:1 allocation (SVd Arm or Vd Arm):
~SVd Arm (~100): ATG-010 + (Once a week, QW) + bortezomib (QW) + dexamethasone (BIW)
~Vd Arm (~50): Bortezomib (Cycles 1-8 [BIW], Cycles ≥ 9 [QW]) + dexamethasone (Cycles 1-8 [Four times a week], Cycles ≥ 9 [BIW])"
15740412|NCT04939129|Diagnostic Test|The research is terminated by calculating the percentage of PVI changes with SAB formed by LRM after fluid challenge.|Measurements will begin after a hemodynamically stable period in the supine position.Heart rate, central venous pressure, systolic, diastolic and mean arterial pressure, peripheral oxygen saturation, PVI and BIS baseline values (baseline 1) will be recorded.LRM will be automatically adjusted in the mechanical ventilator(30 cm H2O/30 seconds) and all hemodynamic parameters where the maximum change at the end of 30 seconds, will be recorded(after LRM), and the differences initial baseline values will be calculated and recorded as percentages.After the recording of the second values, the crystalloid infusion at 10ml/kg will be made to the patient through the peripheral venous line within 15minutes, new baseline values will be taken before the test(baseline 2).After fluid replacement, LRM will be repeated in the same way. The values after LRM(Fluid Challenge-FC) will be recorded and differences between basal 2 values will be calculated and recorded as percentages.
15740413|NCT04939116|Drug|ANG-3070|Orally administered tyrosine kinase inhibitor capsule
15740414|NCT04939116|Drug|Placebo|Orally administered placebo capsule
15740415|NCT04939103|Device|EUS-FNA|transrectal ultrasound-guided core needle biopsy of rectal tumor
15740416|NCT04939090|Drug|Olanzapine|Given PO
15740417|NCT04939090|Drug|Megestrol Acetate|Given PO
15740418|NCT04939090|Other|Questionnaire Administration|Ancillary studies
15740446|NCT04938869|Other|Educational Intervention|Receive basic diabetes mellitus education
15740419|NCT04939077|Biological|Allogeneic Human Umbilical Cord Mesenchymal Stem Cells|In CABG with hUC-MSC treatment group, 1×10^7 Human Umbilical Cord Mesenchymal Stem Cells were injected at the edge of the myocardial infarction area at 20 points at the same time in CABG
15740420|NCT04939051|Biological|Obeticholic Acid|Given PO
15740421|NCT04939051|Drug|Placebo Administration|Given PO
15740422|NCT04939038|Procedure|Revascularization|Depending on the condition of the patients, patients will have either endovascular or surgical revascularization
15740423|NCT04939038|Procedure|Standard wound care|Standard wound care according to guidelines
15740424|NCT04939025|Procedure|Multi-interventional program|"Preoperative oral antibiotics and antibiotic enema of the rectal stump prior to the surgery
~Routine and tailored lengthening measures of the mesentery
~Intraoperative control of pouch vascularization using ICG
~Early diagnosis and active assessment of the integrity of the anastomosis.
~Routine CRP-measurements at day 4 and 6 (after removal pouch catheter) in the non-diverted pouches with CT-scan with rectal contrast if any suspicion on a leak (elevated or rise in CRP. symptoms).
~Routine CRP-measurements at day 4 in the diverted pouches with endoscopy 10-14 days after pouch creation.
~Endosponge vacuum assisted closure (EVAC) of the anastomotic defect aiming to close the defect within 10-14 days after diagnosis.
~MRI assessment of the pouch after stoma closure preferably at one year to rule out chronic sepsis mimicking pouchitis or Crohn's disease."
15740427|NCT04938999|Behavioral|Music-visual guided physical activity (MVgPA)|"The MVgPA adopts the information-motivation-strategy model to address the personal and environmental challenges in PA initiation and maintenance of adults with intellectual disability.
~To support the staff of residential care facilities in implementing 24 sessions of MVgPA in 12 weeks, the first six sessions will be led by the RA1 and co-facilitated by the staff, while the subsequent sessions will be conducted by the staff only. At week 6, another set of MVgPA will be implemented to increase the participant's interest; two sessions will be co-facilitated by RA1. At weeks 6 and 9, the RN and RA1 will hold a meeting with the staff of the residential care facilities to acknowledge the achievement of the staff and adults with ID, as well as to address any of their concerns related to the implementation of MVgPA, and to identify the facilitators and tackle barriers to the implementation of the MVgPA."
15740428|NCT04938999|Behavioral|Usual care|As control group, residential care facilities will conduct their usual activities during the study period. A trained RA will record the activities conducted by the residential care facilities during the study period.
15740429|NCT04938986|Diagnostic Test|IMMUNOSCORE®|recommendation for patient care according to the result of the IMMUNOSCORE®
15740430|NCT04938973|Procedure|Robotic Assisted Minimally Invasive Esophagectomy (RAMIE)|Robotic Assisted Minimally Invasive Esophagectomy (RAMIE) will be performed using the Da Vinci Robotic Surgical Platform.
15740431|NCT04938973|Procedure|Open Transthoracic Esophagectomy (OTE)|Open Transthoracic Esophagectomy (OTE) is the current standard of care.
15740432|NCT04938973|Device|Robotic Assisted Minimally Invasive Esophagectomy (RAMIE)|Robotic Assisted Minimally Invasive Esophagectomy (RAMIE) will be performed using the Da Vinci Robotic Surgical Platform.
15740433|NCT04938960|Diagnostic Test|blood draw|blood will be drawn at pre-operation, 1 month (+/- 1 week), between 2-11 months (optional; we will collect a sample if the patient returns to Mayo Clinic for any other non-study related visit), 1 year (+/- 1 month)
15740434|NCT04938947|Device|Blood Flow Restriction Cuffs|This intervention consists of inflatable cuffs that are designed to partially occlude veinous blood return from the lower extremities during resistance training.
15740435|NCT04938947|Other|Low-Intensity Resistance Training|This intervention consists of performing low-intensity bilateral (both legs at the same time) leg extensions using 30% of a participants 1 repetition maximum (the maximum weight an individual can complete 1 repetition with, but not 2) to volitional failure.
15740436|NCT04938947|Other|High-Intensity Resistance Training|This intervention consists of performing high-intensity bilateral (both legs at the same time) leg extensions using 80% of a participants 1 repetition maximum (the maximum weight an individual can complete 1 repetition with, but not 2) to volitional failure.
15740437|NCT04938934|Behavioral|Lipids infusion|Lipids infusion via intestinal tube
15740438|NCT04938934|Behavioral|Sham infusion|Sham infusion via intestinal tube
15740439|NCT04938908|Drug|Ophthalmic Probiotic|Phospholipid from bacterial lysate of Lactobacillus sakei
15740440|NCT04938908|Drug|Placebo|Placebo contains complete formulation of the active drug except for bacterial lysate of Lactobacillus sakei
15740441|NCT04938895|Behavioral|Exposure to a Photo|We plan to recruit subjects and randomly assign them to one of four treatments. In each treatment arm, the subject will view a photo of a man. We experimentally vary treatment along two dimensions: whether the man is wearing expert vs. layperson attire and whether the man is white vs. black. We will survey participants' willingness to participate in a vaccine clinical trial or research study and how their initial response is impacted by other characteristics such as employment by the pharmaceutical industry or publication history.
15740442|NCT04938882|Drug|Normal saline|Before the induction of anesthesia, normal saline is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side
15740443|NCT04938882|Drug|Ropivacaine|Before the induction of anesthesia, 0.375% ropivacaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side
15740444|NCT04938882|Drug|Compound lidocaine at low concentration|Before the induction of anesthesia, 0.4% compound lidocaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side
15740445|NCT04938882|Drug|Compound lidocaine at high concentration|Before the induction of anesthesia, 0.6% compound lidocaine is used for bilateral transversus abdominis plane block in a volume of 20 mL of each side
15740451|NCT04938843|Dietary Supplement|Placebo|Dietary supplementation with placebo capsules identical to those containing F. prausnitzii and D. piger once daily for 12 consecutive weeks
15740458|NCT04938804|Device|Low-dose computed tomography|The Low-dose computed tomography is conducted according to the guideline suggested by American College of Radiology.
15740460|NCT04938778|Other|PNF|PNF Participants will engage in 8 weeks of 14 hours per night fasting
15740461|NCT04938765|Drug|Magnesium sulfate|Effect of 40mg/kg Magnesium sulfate bolus dosed to ideal body weight on intraoperative neuromonitoring
15740462|NCT04938765|Drug|Normal Saline|20 ml of normal saline bolus will be administered to the control group over 10 mins.
15740463|NCT04938752|Drug|DA-2811|single dose administration (one tablet once a day)
15740464|NCT04938752|Drug|DA-2811-R|single dose administration (one tablet once a day)
15740465|NCT04938739|Other|Cognitive Behavioral Therapy|"The first 6 sessions: the cognitive part was explained with the support of a PowerPoint presentation using diagrams, images, and texts. The therapist explained the lumbar engine behavior, the neurophysiologic basis of pain, the importance of the participant's involvement in the treatment (e.g., coping and motivation), and the maintenance of good ergonomics which was aimed at modifying the physiologic response to the pain system.
~The second 12 sessions: concepts viewed in the first session were revised; as well, the operant and respondent parts were explained."
15740466|NCT04938739|Other|Home program exercises|Each session will include 10 minutes of aerobic activity (walking or stationary bicycle), followed by five types of muscle stretches and eight types of ground exercises aimed at strengthening the lumbar muscles responsible for stabilization.
15740468|NCT04938713|Drug|Ketamine 50 MG/ML|Intravenous Ketalar® 0,30 mg/kg in 1 hour.
15740469|NCT04938713|Drug|Esketamine 25 MG/ML|Intravenous Vesierra® 0,15mg/kg in 1 hour.
15740470|NCT04938700|Drug|probiotics|Probiotics as granules can be used for infants and adolescents
15740471|NCT04938700|Drug|conventional medical treatment|Treatment for allergic diseases includes anti-allergic drugs, nasal spray hormones, inhaled hormones, external hormones, etc
15740472|NCT04938674|Device|ultrasonic guidance|Standard process for blood collection using Ultrasonic Guided puncture
15740473|NCT04938661|Other|Center-Based Cardiac Rehab|36 center-Based Cardiac Rehab Sessions
15740474|NCT04938661|Other|mHealth|Mobile Health Platform
15740475|NCT04938661|Other|Home-Based Cardiac Rehab|Encouraged to exercise 3 times per week at home
15740476|NCT04938648|Behavioral|Pharmacist-led deprescribing intervention|1) direct-to-consumer deprescribing educational materials designed to activate the care partner and people living with dementia PLWD; 2) a telehealth visit in which a clinical pharmacist discusses benefits and harms of the patient's medications with the patient and care partner in the context of their goals and preferences; and 3) pharmacist-PCP communication in which the pharmacist provides tailored deprescribing recommendations designed to be useful and actionable for the PCP
15740477|NCT04938635|Drug|VIT-2763 60 mg QD|Participants receive one VIT-2763 60 mg capsule plus one Placebo capsule orally in the morning, and 2 Placebo capsules orally in the evening, for 24 weeks.
15740478|NCT04938635|Drug|VIT-2763 60 mg BID|Participants receive one VIT-2763 60 mg capsule plus one Placebo capsule orally, twice daily for 24 weeks.
15740479|NCT04938635|Drug|VIT-2763 120 mg BID|Participants receive two VIT-2763 60 mg capsules orally, twice daily for 24 weeks.
15740480|NCT04938635|Drug|Placebo|Participants receive two Placebo capsules matching VIT-2763 orally, twice daily for 24 weeks.
15740481|NCT04938622|Other|Sedentary Control|Diet: Participants consumed meals in the General Clinical Research Center metabolic kitchen that had calories sufficient to maintain body weight. Diet composition was 55 percent carbohydrates, 30 percent fat, and 15 percent protein.
15740482|NCT04938622|Other|Exercising control|Exercise: Participants engaged in supervised exercise training in Noll Laboratory Diet: Participants consumed meals in the General Clinical Research Center metabolic kitchen that had calories sufficient to maintain body weight and additional calories to remain in energy balance. Diet composition was 55 percent carbohydrates, 30 percent fat, and 15 percent protein.
15740483|NCT04938622|Other|15 percent energy deficit|"Exercise: Participants engaged in supervised exercise training in Noll Laboratory that was equal to 15 percent of the participants' daily caloric needs.
~Diet: Participants consumed meals in the General Clinical Research Center metabolic kitchen that had calories to meet metabolic needs (before 15 percent deficit exercise). Diet composition was 55 percent carbohydrates, 30 percent fat, and 15 percent protein."
15740484|NCT04938622|Other|30 percent energy deficit|"Exercise: Participants engaged in supervised exercise training in Noll Laboratory that was equal to 30 percent of the participants' daily caloric needs.
~Diet: Participants consumed meals in the General Clinical Research Center metabolic kitchen that had calories to meet metabolic needs (before 30 percent deficit exercise). Diet composition was 55 percent carbohydrates, 30 percent fat, and 15 percent protein."
15740485|NCT04938622|Other|30 percent energy deficit (15/15)|"Exercise: Participants engaged in supervised exercise training in Noll Laboratory that was equal to 15 percent of the participants' daily caloric needs.
~Diet: Participants consumed meals in the General Clinical Research Center metabolic kitchen that had 15 percent less calories than those needed to meet metabolic needs. Diet composition was 55 percent carbohydrates, 30 percent fat, and 15 percent protein."
15740486|NCT04938622|Other|60 percent energy deficit|"Exercise: Participants engaged in supervised exercise training in Noll Laboratory that was equal to 30 percent of the participants' daily caloric needs.
~Diet: Participants consumed meals in the General Clinical Research Center metabolic kitchen that had 30 percent less calories than those needed to meet metabolic needs. Diet composition was 55 percent carbohydrates, 30 percent fat, and 15 percent protein."
15763276|NCT04750551|Device|EStim|EStim will applied for 10 to 20 minutes.
15740487|NCT04938609|Drug|Pembrolizumab|Pembrolizumab is a humanized anti-PD-1 mAb of the IgG4/kappa isotype with a stabilizing S228P sequence alteration in the Fc region.
15740488|NCT04938609|Radiation|Stereotactic Body Radiation Therapy (5 days)|8Gy x 3 (Mon-Fri) GTV+3mm
15740489|NCT04938609|Procedure|Surgical Resection|Surgical Resection of Tumor
15740490|NCT04938596|Combination Product|Respiratory bundle|"Provision of N95 masks and strong recommendation of use to all household contacts and the index case when sharing a room together, for 2 weeks
~Recommendation to index case to sleep in a room alone, with the door closed and avoid sharing room with others during 2 weeks
~Promotion of strategies to improve house ventilation during 2 weeks
~Provision of a TB leaflet and nurse education about TB transmission."
15740491|NCT04938583|Biological|Oregovomab|"Oregovomab will be administered on day1 cycle 1, 3, 5, and 9 until DLT or disease progression. A minimum of 3 patients will be enrolled into each cohort.
~2 mg, dissolved in 2 mL of 0.9% Sodium Chloride Injection USP, then added to 50 mL of Sodium Chloride Injection USP infused over 20 ± 5 minutes"
15740492|NCT04938583|Drug|Bevacizumab|15mg/Kg Day 1 (every 21 days) until progression
15740493|NCT04938583|Drug|Paclitaxel|175 mg/m^2, Day 1 x 6 cycles (every 21 days)
15740494|NCT04938583|Drug|Carboplatin|AUC 5 IV Day 1 x 6 cycles (every 21 days)
15740495|NCT04938557|Device|Automated closed-loop insulin delivery (AiD)|Closed-loop systems are designed to deliver insulin in response to CGM glucose levels and may help to improve glucose control above and beyond what is currently achievable using insulin pumps, injections and CGM without AiD.
15740496|NCT04938557|Device|A standard insulin delivery system|Self-directed insulin delivery for pregnant women with T1D, which is insulin pump or MDI.
15740497|NCT04938531|Other|Exercise|Participants will perform an entry passive exercise test within 48 hours of onset of severe sepsis. Patients then will perform 30-60 min supine passive cycle ergometry exercise 5 days/week.
15740498|NCT04938492|Behavioral|Cognitive Behavioral Therapy for loneliness (CBT-L)|6 sessions focused on addressing thoughts, emotions, and behaviors that maintain feeling alone as a way to reduce loneliness and substance use.
15740499|NCT04938492|Behavioral|Physical Health Education Training (PHET)|Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.
15740500|NCT04938479|Biological|blood sample|D-dimer measurement in blood sample
15740501|NCT04938466|Drug|Long-Acting Growth Hormone (LAGH)|Long-acting growth hormone (LAGH) treatment
15740502|NCT04938453|Drug|nintedanib (formulation A, test treatment)|nintedanib (formulation A, test treatment)
15740503|NCT04938453|Drug|nintedanib (formulation B, reference treatment)|nintedanib (formulation B, reference treatment)
15740506|NCT04938414|Diagnostic Test|Lumbar puncture|Lumbar puncture to obtain the cerebrospinal fluid and for diagnostic test
15740507|NCT04938388|Drug|Semaglutide Pill|All participants will start at a 3 mg dose of OS or matched Placebo. If this minimum dose is not tolerated, the participant will be withdrawn from the study. After 4 weeks, the OS dose (or Placebo) will be adjusted to 7 mg. After a further 4 weeks of study and thereafter, the OS dose (or Placebo) will be adjusted at the study physician's discretion to 14 mg. At each study visit, the current dose of OS (or Placebo) will be maintained, unless participants report moderate-to-severe nausea or vomiting for 3 or more days in the week before the scheduled visit.
15740508|NCT04938388|Dietary Supplement|Fresh organic vegetables|Prescriptions of organic vegetables
15740509|NCT04938362|Other|FDG-PET|[18F]Deoxyglucose-positron emission tomography at 0-10 years after brain abscess
15740510|NCT04938349|Behavioral|Dual task perturbation training|Participants will play six cognitive games targeting working memory, executive functioning, visuomotor reactions, and language fluency provided in standing. Following which they will receive 12 slips without performing cognitive task (Single task training) at the highest intensity and 12 slips during standing while performing a cognitive task (dual task). Also, they will then undergo 12 dual task walking trials (at self-selected speed) followed by 12 walking slips.
15740511|NCT04938336|Behavioral|Delphi Procedure and interviews|Delphi procedure with expert healthcare professionals and interviews with patients, healthcare professionals and informal carers
15740512|NCT04938323|Drug|BCG Vaccine|.1 mL of reconstituted BCG vaccine given intradermally at baseline.
15740513|NCT04938323|Drug|Placebo|.1 mL of diluent (saline) given intradermally at baseline
15740514|NCT04938310|Procedure|sleeve gastrectomy|sleeve gastrectomy
15740515|NCT04938310|Device|support garment|A custom made support garment
15740516|NCT04938297|Drug|Rituximab, Lenalidomide, Zanubrutinib|Induction therapy: Rituximab 375 mg / m2, day 1, Zanubrutinib 160 mg bid, orally, Lenalidomide 25mg QD, orally on day 1-21, 28 days as a course of treatment, 8 courses of treatment.
15740517|NCT04938297|Drug|Lenalidomide, Zanubrutinib|Maintenance therapy: Lenalidomide: 25mg qd (adjusted according to hectogram condition) or Zanubrutinib 160 mg bid. Continuously use for 2 years or until disease progression
15740518|NCT04938297|Drug|Lenalidomide|Maintenance therapy: Lenalidomide: 25mg qd (adjusted according to hectogram condition) . Continuously use for 2 years or until disease progression
15740519|NCT04938284|Device|PAS|Paired associative stimulation is a combination of non-invasive transcranial magnetic stimulation (TMS) and non-invasive peripheral nerve stimulation (PNS)
15740520|NCT04938284|Device|VNS|Non-invasive vagus nerve stimulation delivered through cymba concha & cymba cavum of the ear.
15740553|NCT04937907|Drug|Hydroxychloroquine Sulfate 100 milligram (mg) Tab|Patients administered HCQ by oral at a dose of 6.5mg per kilogram twice a day at least 6 months.
15740554|NCT04937907|Drug|Benazepril hydrochloride 10 milligram (mg) Tab|Patients administered Benazepril by oral at a dose of 5mg or 10mg once a day at least 6 months.
15740555|NCT04937894|Drug|Tigecycline|Efficacy and safety of Tigecycline
15740522|NCT04938258|Behavioral|Intensive Case Management|Participants will receive an intensive Case Management (CM) intervention conducted by a multidisciplinary team (Psychiatry, Social Work, Nursing) during 2 months. The intervention will encompass attending weekly or biweekly appointments with the CM team, the interviews will last approximately 30 minutes. This CM intervention will include referral to Hospital Clínic de Barcelona Addiction Outpatient Clinic and a personalised assessment of the medical, psychiatric and social situation of each individual by the CM team. An individualised care plan will be established and periodically reviewed by the multidisciplinary team in response to a better understanding of patient needs or to a change in patient health condition. The intervention will offer motivational interviewing psychotherapy to enhance motivation to reduce or to quit alcohol use, in crisis intervention, coordination of care, patient education and self-management support, and assistance to navigate in the healthcare system.
15740523|NCT04938245|Device|Spinal Cord Stimulation|"Intraoperatively, stimulation at 12 Hz will be performed as the leads are moved into the targeted position. Amplitude will be increased to 15 mA maximum total until a response is seen on any electrode and held for 10 seconds. Stimulation and recording will be performed using the Neuralynx stim/record system.
~Post-operatively, the electrodes will be tested for impedance by the clinical system and then they will be connected to the Neuralynx stim/record system. Electrode stimulation patterns will be applied with increasing amplitude until ECAPs responses are seen on recording electrodes. 42 Hz stimulation will be performed with an amplitude sweep of 0mA-10mA. At each amplitude, stimulation will be applied for 4 seconds followed by 2 seconds of rest. Pulse width will be varied from 30-450 microseconds to test effective amplitude. Bursting stimulation will be applied to detect differences in ECAPs as above."
15740524|NCT04938232|Drug|Nivolumab|Intravenous infusion
15740525|NCT04938232|Drug|Ipilimumab|Intravenous infusion
15740526|NCT04938219|Other|Gloves filled with warm tap water|The intervention in the treatment group will consist of nonsterile gloves, filled with regular tap water at a comfortable warm temperature and sealed with a plastic clip. The temperature of the water will not be measured, the investigators will take a temperature that feels comfortable in their hands
15740527|NCT04938206|Procedure|The Clinical Decision Rule|The Clinical Decision Rule will be applied to all patients included in the study at different times depending on the type of cancer: at H12-H24 of admission for patients with solid tumor; at H24-H48 for patients with hematological cancer. Patients classified as being at low risk of severe infection by the DRC were then randomized to a control group under standard management or to an experimental group with therapeutic relief. Treatment reduction for the experimental group was started immediately after randomization, in hospital. Discharge was proposed 24 hours later, with follow-up every two days, by telephone or in
15740528|NCT04938193|Diagnostic Test|68Ga-citrate PET/CT|PET/CT Imaging with 68Ga-citrate PET/CT injection
15740529|NCT04938180|Biological|AMB-05X|A fully human monoclonal immunoglobulin (IgG2) directed against c-fms
15740530|NCT04938167|Other|95% - 99% SpO2 target|If the infant is randomized to the intervention arm, the oxygen saturation goal will be changed from the standard goal of 91% - 95% to the experimental goal of 95%-99%. The treating medical team will then adjust the oxygen and respiratory support to maintain these goals (SpO2 alarm levels will be set at 93% and 100%).
15740531|NCT04938154|Device|DBS ON|The DBS system will be turned on and the patient will be left on their best setting for 3 months.
15740532|NCT04938154|Device|DBS OFF|The DBS system will be turned off, and will be left off for 3 months.
15740533|NCT04938128|Device|CPAP|Gold standard treatment for obstructive sleep apnea. In this group, patients will be prescribed CPAP treatment according to local policy.
15740534|NCT04938115|Biological|CD7 CART|Biological: CD7 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis
15740535|NCT04938102|Drug|Botulinum Toxin Type A Injection [Botox]|Injection of 100 units of botulinum toxin into the lower esophageal sphincter (25 units in each quadrant).
15740536|NCT04938089|Other|Maintenance|Regular compliant individual is defined in the study as a subject attending 100% of his/her recall visits with a maximum interval of 6 months. Irregular compliant individual is defined as a subject who missed at least one of the recall visits but continued to appear on an irregular basis with a maximum interval of 18 months, non-smoker individual is defined as a subject who never smoked, and lastly, smoker individual is defined as a subject who is smoking > 9 cigarettes per day.
15740537|NCT04938076|Device|Transcranial direct current stimulation|Transcranial direct current stimulation on motor cortex
15740538|NCT04938063|Other|Assessing the correlation between Functional Impairment and Parenting Stress|Association Between Functional Impairment and Parenting Stress Among Children Diagnosed With Diplegic Cerebral Palsy
15740539|NCT04938050|Diagnostic Test|Ultrasound|Ultrasound evaluation, with grayscale and color Doppler imaging.
15740540|NCT04938037|Procedure|US guided, SSNB with 1ml methylprednisolone acetate (1ml / 40mg) and 5 ml 0.5% bupivacaine|nerve block
15740541|NCT04938024|Dietary Supplement|Vitamin C|Vitamin C is a commercially available over-the-counter food supplement.
15740542|NCT04938011|Drug|progesterone|the transfer of day 6 blastocyst on the 6th day of progesterone supplementation
15740543|NCT04938011|Drug|progesterone|the transfer of day 6 blastocyst on the 7th day of progesterone supplementation
15740544|NCT04937998|Procedure|Autologous PRP injection|Patients will be treated with a single injection of Autologous PRP (5 ml) in the knee joint affected by patellofemoral osteoarthritis
15740545|NCT04937998|Procedure|HA injection|Patients will be treated with a single injections of Hyaluronic Acid (5 ml) in the knee joint affected by patellofemoral osteoarthritis
15740546|NCT04937985|Other|Performance Tests|Performance tests consist of Six Minute Pegboard Ring Test, 30-Second Push-Up Test and Arm, Shoulder and Hand Injury Questionnaire (DASH), Neck Disability Index, New York Posture Rating Chart and Short Form-36 Health Survey.
15740547|NCT04937972|Drug|SHR-1701 Combined With Fluazopalil|SHR-1701 +fluzoparib
15740548|NCT04937946|Drug|Fentanyl|Fentanyl will be administered as an intravenous loading dose of 1 microgram/kg in 30 minutes, followed by a continuous intravenous infusion of 1μg/kg/hour. The infusion will be administered through a peripheral line. Fentanyl infusion will be initiated within 24 hours after the start of mechanical ventilation and will be continued until the end of mechanical ventilation, and not longer than 5 days .
15740549|NCT04937933|Drug|Coolant spray (Cryos ®Spray, Phyto Performance, Italy)|The coolant spray treatment method is a cryotherapy non-pharmacological treatment choice.
15740550|NCT04937933|Drug|Saline solution|saline solution
15740557|NCT04937881|Drug|Tenofovir Disoproxil Fumarate|Daily DOT fixed dose combination of 200 mg emtricitabine (FTC) and 25 mg tenofovir alafenamide (TAF)
15740558|NCT04937868|Other|There are no interventions associated with this study|This study is purely observational, there will be no interventions or changes in care related to patient inclusion in this study.
15740559|NCT04937855|Other|no intervention|no intervention
15740560|NCT04937842|Biological|microtransplantation, HLA-mismatched donor peripheral stem cell infusion|infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC)
15740561|NCT04937829|Drug|BI 1569912|BI 1569912
15740562|NCT04937829|Drug|Placebo|Placebo
15740563|NCT04937816|Drug|Placebo|Placebo
15740564|NCT04937816|Drug|Empagliflozin|Empagliflozin once daily
15740565|NCT04937803|Device|Drug-coated balloon|Drug-coated balloon is a fast-exchange balloon dilatation catheter, used to treat coronary artery stenosis lesions and improve myocardial blood flow.
15740566|NCT04937803|Device|Zotarolimus-Eluting Coronary Stent|Zotarolimus-Eluting Coronary Stent is treated for coronary artery stenosis lesions .
15740567|NCT04937790|Behavioral|Core stabilization group(CSG)|Exercises training of this group occurs from 3 stages. In the stage 1 covering the first two weeks, core stabilization exercises are going to be applied 3 sets of 10 repetitions except side plank. Side plank is going to be performed 3 sets of 10 seconds. Stage 2 is going to include from 3 to 5 weeks. In this stage, exercises are going to be performed 3 sets of 12 repetitions except bride dog, plank and side plank. These exercises are going to be applied 3 sets of 15 seconds. Patients are going to perform exercises of stage 3 from 6 to 8 weeks. Exercises of stage 3 are going to be practiced 3 sets of 15 repetitions except bride dog, side plank and plank exercises which are going to be applied 3 set of 20 second. All stages include the same exercises except modified push-up exercise includes instead of plank exercise in stage 1. All of the exercises are going to practiced 3 days a week for 8 weeks. One of the sessions is estimated to take approximately 45-60 minutes.
15740568|NCT04937790|Behavioral|Wobble board group (WBG)|Patients in this group are going to perform exercise on computerized wobble board. This device is going to provide unstable surface to patient and offer visual feedback about their movement qualities. The 8 weeks program consists of 3 stages and each stage includes six exercises. In the first stage covering the first two weeks, repetitive exercises are going to be practiced 3 sets of 10 repetitions; time controlled exercises are going to be practiced 3 sets of 20 seconds. Stage 2 is going to include from 3 to 5 weeks. In this stage, repetitive exercises are going to be performed 3 sets of 12 repetition and time controlled exercises are going to be performed 3 sets of 25 seconds. Stage 3 is going to last from 6 to 8 weeks. In this stage, repetitive exercises are going to be practiced 3 sets of 15 repetitions and time controlled exercises are going to be practiced 3 sets of 30 seconds. One of the sessions is estimated to take approximately 45-60 minutes.
15740569|NCT04937751|Diagnostic Test|biomarkers|galactomannan, betaDglucan, resistance markers
15740570|NCT04937738|Drug|Docetaxel|50mg/m2, d1, i.v., every 2 weeks
15740571|NCT04937738|Drug|Oxaliplatin|85 mg/m², d1, i.v., every 2 weeks
15740572|NCT04937738|Drug|Leucovorin|200 mg/m², d1, i.v., every 2 weeks
15740573|NCT04937738|Drug|Fluorouracil|2600 mg/m²d1 i.v. every 2 weeks
15740574|NCT04937738|Drug|Capecitabine|1000 mg/m² two times per day (BID), d1-14
15740575|NCT04937738|Drug|Oxaliplatin|130 mg/m² d1 i.v. every 3 weeks
15740576|NCT04937725|Diagnostic Test|eye tracking|Eye tracker will be used to evaluate study parameters
15740577|NCT04937712|Other|RT-PCR SARS-COV2 in urine|proteinuria/renal phosphate leak/uricosuria/glycosuria/ aminoaciduria)
15740578|NCT04937699|Drug|Standard-Does Ticagrelor plus aspirin|ticagrelor 90mg bid plus aspirin 100mg qd, for 12months after randomization
15740579|NCT04937699|Drug|Low-Does Ticagrelor monotherapy|Ticagrelor 60mg bid+Aspirin 100mg qd for 1 month after randomization, then ticagrelor 60mg bid for 5 months; clopidogrel 75mg qd, for another 6 months.
15740580|NCT04937673|Drug|Camrelizumab+Albumin bound paclitaxel+Cisplatin|"Camrelizumab: intravenous drip, fixed dose 200 mg, D1, repeated once every 3 weeks.
~Albumin bound paclitaxel: 130 mg / m2, intravenous drip for 30 minutes, D1, D8, repeated every 3 weeks.
~Cisplatin: 75 mg / m2, intravenous drip for 120 minutes, D1, repeated every 3 weeks."
15740581|NCT04937673|Drug|Camrelizumab+ Paclitaxel+ Cisplatin|"Camrelizumab: intravenous drip, fixed dose 200 mg, D1, repeated once every 3 weeks.
~Paclitaxel: 80 mg / m2, intravenous drip for 180 minutes, D1, D8, repeated every 3 weeks.
~Cisplatin: 75 mg / m2, intravenous drip for 120 minutes, D1, repeated every 3 weeks."
15740582|NCT04937647|Other|collection of endoscopic images and videos|collection of endoscopic images and videos
15740583|NCT04937634|Drug|Melphalan|The subject receives conditioning regimen including melphalan as a part of hematopoietic stem cell transplantation. Dosage of melphalan is 50mg/m^2/day. Infuse Melphalan over 30 minutes.
15740584|NCT04937621|Diagnostic Test|ECG data analysis|Baseline ECG as well as follow-up ECG are analysed
15740585|NCT04937621|Drug|Treatment data collect|Baseline treatment data as well as follow-up treatment data are collected
15740586|NCT04937621|Biological|Biological check-up data collect|Baseline Biological check-up data as well as follow-up data are collected
15740587|NCT04937621|Other|Collection of clinical events of interest|Clinical events of interest at the baseline as well as follow-up clinical events are collected
15740588|NCT04937608|Diagnostic Test|Sperm analysis|Routine sperm analysis including analysis of sperm concentration, motility, vitality and morphology. Sperm DNA integrity will also be assessed.
15740589|NCT04937582|Diagnostic Test|Cognitive assessment|Complete cognitive and psychological assessment
15740590|NCT04937582|Diagnostic Test|Imaging|"Brain MRI
~Optional: Brain FDG PET (Brain positron emission tomography with F-18 fluorodeoxyglucose)"
15740591|NCT04937582|Diagnostic Test|Routine care|"Electroencephalogram (EEG)
~Optional: polysomnography, lumbar puncture"
15740592|NCT04937582|Other|Psychiatric evaluation|Psychiatric consultation if necessary
15740593|NCT04937582|Other|Psychiatric evaluation|Psychiatric consultation if necessary (before the end of their participation in the study)
15740594|NCT04937569|Drug|Ivermectin Tablets|4-days course of Ivermectin 400 microgram/kg body weight maximum 4 tablets (6mg / tablet) once daily dose before breakfast
15740630|NCT04937309|Device|sham stimulation|Stimulation twice a day, beginning the day before until the fourth day after chemotherapy, for the three first chemotherapy cycles, with a sham device
15740595|NCT04937556|Dietary Supplement|Probiotic: Lactobacillus salivarius + Vit D + Zinc|A mixture of 1*10E9 colony forming unit (CFU) of Lactobacillus salivarius + Vit D + Zinc citrate in 1 capsule will be daily administrated during 28 days.
15740596|NCT04937556|Dietary Supplement|Placebo|Placebo in 1 capsule will be daily administrated during 28 days.
15740597|NCT04937543|Drug|inhaled beclametasone|Adding belcamethasone to standard of care for Covid 19 positive patients
15740598|NCT04937543|Drug|Inahaled beclomethasone / formoterol / glycopyrronium|Adding belcametasone/ formoterol / glycopyrronium to standard of care for Covid 19 positive patients
15740599|NCT04937530|Drug|RT001|RT001 8.64 g/d (3 capsules TID) for 1 month followed by 5.76 g/d (3 capsules BID) for an additional 11 months
15740600|NCT04937530|Drug|Placebo|Placebo Comparator: Placebo Inactive comparator capsule 960 mg/capsule: 3 capsules TID for 4 weeks, followed by 3 capsules BID for the remaining 44 weeks.
15740601|NCT04937504|Behavioral|STAIR-PC Group|Skills Training in Affective and Interpersonal Regulation for Primary Care (STAIR-PC) is a face-to-face, individual, brief (5 session) therapy adapted from the STAIR program. STAIR-PC is an appropriate treatment for individuals who have experienced traumatic stressors, and addresses symptom targets by teaching skills to improve coping with emotions and strengthen interpersonal relationships.
15740602|NCT04937504|Behavioral|WebSTAIR Group|WebSTAIR is a web-based self-help program adapted from the STAIR program for individuals who have experienced traumatic stressors. WebSTAIR contains 10 self-guided interactive modules that teach skills to improve coping with emotions and strengthen interpersonal relationships.
15740603|NCT04937491|Device|New medical device (ReBalans)|Body worn, battery powered bioimpedance measuring patch device.
15740604|NCT04937478|Other|Observation|Only observational study, no intervention.
15740605|NCT04937465|Other|No intervention done|No intervention was done. This was an observational study.
15740606|NCT04937452|Drug|Rotigotine 4Mg/24Hrs Patch|Rotigotine 4 mg/24Hrs administration for 24 weeks
15740607|NCT04937452|Drug|Rotigotine 6Mg/24Hrs Patch|Rotigotine 6 mg/24Hrs administration for 24 weeks
15740608|NCT04937452|Drug|Placebo|Placebo administration for 24 weeks
15740609|NCT04937439|Other|Traditional Physical Therapy program|"Facilitation of head control will be conducted.
~Facilitation of trunk control will be applied
~Facilitation of rolling
~Facilitation of righting, protective and equilibrium reactions from supine, prone and sitting on a ball
~Stretching exercises for the muscles liable to be tight
~Facilitation of sitting"
15740610|NCT04937439|Other|Segmental trunk training A|Group (A) will wear an external segmental trunk support extended from the level of pelvis to a level just below the rib cage.
15740611|NCT04937439|Other|Segmental trunk training B|Group (B) will receive the same program given to (group A) while wearing an external segmental trunk support extended from the level of pelvis to a level just below the inferior angle of scapula.
15740612|NCT04937439|Other|Segmental trunk training C|Group (C) will receive the same program given to (group A and B) while wearing an external segmental trunk support extended from the level of last rib to the level of the inferior angle of scapula.
15740613|NCT04937426|Diagnostic Test|Fluorescent-labeled Urease Inhibitor Marker to Detect Helicobacter Pylori|Diagnostic laboratory test for detection of helicobacter pylori
15740614|NCT04937413|Drug|Evolocumab|Evolocumab subcutaneous injection
15740615|NCT04937400|Other|Daily screening for delirium|Each child will be screened twice daily for delirium throughout the transplant hospitalization
15740616|NCT04937387|Drug|FF/VI|FF/VI will be administered.
15740617|NCT04937387|Drug|FF/UMEC/VI|FF/UMEC/VI will be administered.
15740618|NCT04937387|Device|ELLIPTA|FF/UMEC/VI and FF/VI will be administered via ELLIPTA inhaler.
15740621|NCT04937361|Other|rectal swab|collection of rectal swabs
15740622|NCT04937348|Diagnostic Test|Acquisition and analysis of milk samples|"In order to ensure reproducible results, breast milk samples were collected using a breast pump. Samples were taken in the morning, after the newborn was breastfed. The entire breast was emptied. In order to ensure the stability of the microbiological and nutritional composition, the milk samples were cooled immediately after collection, and then divided into test tubes and frozen (-80 C) until the laboratory tests were made.
~The concentrations of macronutrients (protein, fat, carbohydrate) in breast milk were determined using a Human Milk Analyzer (HMA; Miris, Uppsala). Tissue hormones, e.g. adipokines: visfatin, omentin-1 were determined by ELISA method using commercial reagent kits."
15740623|NCT04937348|Diagnostic Test|Collection, preparation and analysis of mother's blood samples.|Blood samples were collected from the mothers (fasting if possible) on the day the milk samples were taken. After collection, fasting glucose and insulin, as well as glycated hemoglobin were marked, and the other samples were centrifuged and frozen until analyzed (-80 C). Determination of adipokines was performed by ELISA method, using commercial reagent kits.
15740624|NCT04937348|Diagnostic Test|Body composition assessment|The body composition of newborns was determined by a non-invasive electrical bioimpedance method using the body composition analyzer.
15740625|NCT04937348|Other|Anthropometric measurements|"Based on the mother's medical records, maternal height and pregnancy weight changes were recorded. On the day the biological material is collected, the mother was weighed.
~From the baby's documentation, measurements of the length, head circumference and body weight taken after delivery and during the hospitalization were recorded. These measurements were repeated on the days of the body composition analysis."
15740626|NCT04937335|Other|intratumoral hemorrhage|Patients who were recognized as craniopharyngioma pathologically with tumoral hemorrhage observed during the operation were enrolled in the hemorrhage group.
15740627|NCT04937322|Procedure|Interventional Endoscopy procedures|• All patients who have had Interventional Endoscopy procedures done which involved radio frequency ablations and stent insertion(s) for pancreatico-biliary disorders.
15740628|NCT04937309|Device|non invasive auricular vagal stimulation|Stimulation twice a day, beginning the day before until the fourth day after chemotherapy, for the three first chemotherapy cycles
15740629|NCT04937309|Drug|usual medical treatment|Standard anti emetic treatments to prevent emesis due to chemotherapy
15740631|NCT04937296|Behavioral|Physical activity|Participants will be asked to perform resistance exercises 3-times a week on alternating days for 12 weeks. Exercises will be performed with a TheraBand and will include the squat, lunge, press-up, cross body reach, reverse fly, lateral raise, biceps curl, triceps extension, frontal raise and bridge. In addition to the resistance exercises, the participants will perform aerobic exercise. They will be asked to download a specific exercise app to record the number of steps on day 1 of the intervention and participants who do not possess the required phone technology will be provided with a pedometer. They then will be asked to add 2000 steps on to their daily steps; this amount will then become their daily step goal. Once they have reached this goal on 4 out of 5 days, they will be asked to increase their new step step goal by an extra 500 per day.
15740632|NCT04937296|Other|Usual care|Usual care.
15740633|NCT04937283|Procedure|Segmentectomy with systemic lymph node dissection|Segmentectomy with hilar and mediastinal lymph node dissection is performed. If the tumor located at inter-segment plane and without sufficient resection margin distance, a combined segmentectomy will be performed. Systemic or selective lymph node dissection is mandatory, and nodal sampling is not allowed. At least three stations of mediastinal lymph node from 2R, 4R, 7, 8, 9 for the right side and 5, 6, 7, 8, 9 for the left side, respectively. The distance from the dissection margin to the tumor edge must be evaluated intra-operatively. If the distance is either less than the maximum tumor diameter or 20 mm, the absence of cancer cells in the resection margin must be histologically or cytologically confirmed before finishing surgery.
15740634|NCT04937283|Procedure|Lobectomy with hilar and mediastinal lymph node dissection|Lobectomy with hilar and mediastinal lymph node dissection is performed. Segmentectomy with hilar and mediastinal lymph node dissection is performed. Systemic or selective lymph node dissection is mandatory, and nodal sampling is not allowed. At least three stations of mediastinal lymph node from 2R, 4R, 7, 8, 9 for the right side and 5, 6, 7, 8, 9 for the left side, respectively. The distance from the dissection margin to the tumor edge must be evaluated intra-operatively. If the distance is either less than the maximum tumor diameter or 20 mm, the absence of cancer cells in the resection margin must be histologically or cytologically confirmed before finishing surgery.
15740635|NCT04937270|Device|High frequency therapy (5 minutes)|The high-frequency therapy device (radio frequency therapy, WINBACK, Villeneuve Loubet France) used in this study was used to treat deep heat for 5 minutes using a 300 kHz capacitive electrode (CET) and a 500 kHz resistive electric transfer (RET). transmit
15740636|NCT04937270|Device|High frequency therapy (7 minutes)|The high-frequency therapy device (radio frequency therapy, WINBACK, Villeneuve Loubet France) used in this study was used to treat deep heat for 7 minutes using a 300 kHz capacitive electrode (CET) and a 500 kHz resistive electric transfer (RET). transmit
15740637|NCT04937270|Device|High frequency therapy (9 minutes)|The high-frequency therapy device (radio frequency therapy, WINBACK, Villeneuve Loubet France) used in this study was used to treat deep heat for 9 minutes using a 300 kHz capacitive electrode (CET) and a 500 kHz resistive electric transfer (RET). transmit
15740638|NCT04937257|Other|Virtual Reality|The training included the following in the specified order: (1) A tutorial with an introduction to the program and a overview of the correct donning and doffing sequence, based on Center for Disease Control (CDC) guidelines, (2) a training mode to practice the correct sequences with step-wise feedback, and (3) a testing mode that repeated until the sequence was completed perfectly without any mistakes. A study member was present to assist with the device and record the duration of training.
15740639|NCT04937257|Other|E-module|The instructional video included step-by-step instruction and demonstration of adequate donning and doffing procedures. The 14-slide presentation contained the same content as used by the home institution for competency training, based on Center for Disease Control (CDC) guidelines. Participants were instructed to review the material however they liked and their duration of training was recorded.
15740640|NCT04937244|Diagnostic Test|5ALA exoscopic fluorescence filter|Visualization of tumor tissue with 5ALA will be done in the operating room to localize neoplastic tissue. The operation will be conducted in a standard fashion uninfluenced by the imaging on the ORBEYE exoscope. The ORBEYE exoscope will be used with the blue light filter after tacking up dura upon first visualization of tumor tissue prior to direct resection. Images will be taken prior to, during and at the end of the planned resection. The ORBEYE exoscope will be set up at constant distances from the target and incident light intensities. The focal distance and light intensity settings will be recorded from the data displayed on the microscope. The ORBEYE exoscope or standard operating microscope (depending on surgeon preference) will then be used in the standard fashion of an operative microscope with a fluorescent filter, to assist with surgical resection as per the surgeon's preference. Resection will proceed according to current standard of care.
15740644|NCT04937218|Behavioral|Egg demand creation campaign|Egg demand creation campaign including 14 months of above-the-line and below-the-line messaging.
15740645|NCT04937205|Behavioral|MOVE|The MOVE physical activity support program is based on the Self-Determination Theory and targets autonomous motivation for physical activity by encouraging 1) choice in physical activity type (e.g. walking, household chores, yoga), 2) a meaningful, value-based rationale for engaging in physical activity, and 3) physical activity that is intrinsically enjoyable. MOVE was delivered during two, 60-75 minute group-based classes and one, 45 minute individualized 1:1 support session to enhance adherence to physical activity recommendations within a lifestyle weight loss program. The group-based classes included a combination of PowerPoint slides, participant handouts, and group-based discussions. All MOVE content was delivered by trained study staff.
15740646|NCT04937192|Other|No intervention|No intervention
15740647|NCT04937179|Procedure|Ischemic Conditioning Low - Sham Comparator|The use of a Hokanson rapid inflator cuff to restrict blood flow at 25mmHg for 5 minutes followed by a 5 minute reperfusion period, repeated for 5 cycles.
15740648|NCT04937179|Procedure|Ischemic Conditioning High - Active Comparator|The use of a Hokanson rapid inflator cuff to restrict blood flow at 225mmHg for 5 minutes followed by a 5 minute reperfusion period, repeated for 5 cycles.
15740649|NCT04937166|Biological|DSP107|DSP107 (SIRPα - 4-1BBL) is a bi-functional, trimeric, fusion protein.
15740650|NCT04937166|Drug|Azacitidine|Azacitidine is an analog of the pyrimidine nucleoside cytidine.
15740651|NCT04937166|Drug|Venetoclax|Venetoclax is a B-cell lymphoma (BCL)-2 inhibitor
15740652|NCT04937153|Biological|GEN1046|GEN1046 will be administered intravenously once every 21 days. The dose levels will be determined by the starting dose and the escalation steps taken in the trial.
15740653|NCT04937140|Diagnostic Test|14-3-3 η (eta) protein antibodies in the serum of rheumatoid arthritis patients|assessment of 14-3-3 η (eta) protein antibodies in the serum of rheumatoid arthritis patients and Carotid Doppler ultrasound (for measurement of carotid intima media thickness and detection of plaques)
15740654|NCT04937127|Behavioral|I-LEARN training|Training of psycho-behavorial disorders care in neurodegenerative diseases: including a theoretical part in e-learning and a practical part
15740655|NCT04937127|Other|usual care|usual care
15740656|NCT04937114|Procedure|Barbed suture|Experimental: Wound will be closed using unidirectional barbed sutures in muco-gingival surgeries Active Comparator: Wound will be closed using conventional sutures in muco-gingival surgeries
15740657|NCT04937101|Drug|Chlorpheniramine-Codeine|When the filter tester is sensitive, he opened the random letter group envelope to the notification letter manager and jointly confirmed the classification of the message group. The test group used the chlorpheniramine beacon, the physiological surface was used, and the local lesions of fine particles were used in the focus. Injection therapy. No form of anesthesia is used during injection. A total of injection treatment, at intervals, each treatment and the last treatment, treatment and safety after 1 month.
15740658|NCT04937088|Drug|ASA|Liquid aspirin formulation
15740659|NCT04937075|Other|No intervention|No intervention
15740660|NCT04937062|Drug|Glycerol Phenylbutyrate 1100 MG/ML [Ravicti]|"The investigator will rapidly titrate to a goal dose of 11.2 mL/m2 (12.4 g/m2) in three equally divided doses given enterally (by mouth or if necessary by g-tube) for 6 weeks, followed by a 2-week taper. This dose is consistent with the dosing guidelines in the FDA approved Medication Guide. Families will have the option to continue phenylbutyrate therapy at the goal dose of 11.2 mL/m2 (12.4 g/m2) in three equally divided doses given enterally for one additional year.
~(https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/203284s005lbl.pdf)."
15740661|NCT04937049|Other|EMAeHealth digital tool|eHealth intervention to support Maternal Education
15740662|NCT04937036|Diagnostic Test|Polysomnography|Each of the patients will undergo polysomnography
15740663|NCT04937023|Drug|Ursodeoxycholic acid gel|Following scaling and root planing in intrabony defects UDCA gel will be injected
15740664|NCT04937010|Procedure|Occipital nerve stimulator implant|Implantation of occipital nerve stimulator and different stimulation parameters
15740665|NCT04936997|Biological|SARS-COV2 Pfizer Vaccine|Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).
15740666|NCT04936984|Combination Product|abaloparatide-sMTS (Patheon)|single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes
15740667|NCT04936984|Combination Product|abaloparatide-sMTS (Kindeva)|single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes
15740668|NCT04936984|Combination Product|abaloparatide-sMTS (Patheon)|single-dose administration of abaloparatide 300 μg applied to the thigh for 4 minutes
15740669|NCT04936984|Combination Product|abaloparatide-sMTS (Patheon)|single-dose administration of abaloparatide 300 μg applied to the thigh for 7 minutes
15740670|NCT04936971|Drug|Switch from Mycophenolate Mofetil to Everolimus manteinance treatment in Active Comparator Arm|Switch from Mycophenolate Mofetil in Active comparator Arm if assymptomatic Cytomegalovirus viremia >1000-<5000 copies/mL observed
15740671|NCT04936971|Other|no intervention|Manteinance of assigned Arm treatment even if assymptomatic Cytomegalovirus viremia >1000-<5000 copies/mL observed
15740672|NCT04936958|Other|patients having had an osteomyelitis since 2017|description of osteomyelitis and their management
15740673|NCT04936945|Procedure|Temporomandibular joint arthroscopy plus intra-articular injection|patients with TMJ degenerative joint diseases Wilkes stages IV, V not responding to conservative treatment will undergo operative diagnostic arthroscopic treatment then at the end of the procedure intra-articular injection of platelet rich plasma or hyaluronic acid will be done.
15740674|NCT04936932|Device|1064 nm long-pulse Nd:YAG laser|BCC lesion will be treated with long-pulse 1064 laser
15740675|NCT04936932|Device|1064 nm long-pulse Nd:YAG laser|BCC lesion will be treated with long-pulse 1064 laser
15740676|NCT04936919|Device|BroadBand Light|Treatment arm will receive Broadband light treatment
15740677|NCT04936906|Behavioral|Extra Care (EC) Intervention|The EC intervention includes pre- and post- procedure calls from the surgeon, written educational material, personalized music during the operation, post-procedure skin cancer protection education, and are allowed to bring a guest into the procedure room.
15740678|NCT04936906|Other|Usual Care (UC)|Standard of care pre and post surgery management provided to patients undergoing Mohs Surgery.
15740679|NCT04936893|Behavioral|Mindfulness Practice|10-15 mins of daily mindfulness practice using HeadSpace, for 3 weeks
15740680|NCT04936893|Behavioral|Cognitive training|10-15 mins of cognitive games using Lumosity, for 3 weeks
15740681|NCT04936880|Device|Experimental : Virtual reality + analgesia-sedation|Use of a virtual reality device + analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure
15740682|NCT04936880|Drug|Control: Analgesia-sedation|Use of analgesia-sedation drugs according to SFMU/SFAR 2010 guidelines during reduction procedure
15740683|NCT04936854|Drug|Sirolimus 1 mg Oral Tablet|2 mg Sirolimus (two 1 mg tablets) on the first day, followed by 0,5 mg Sirolimus (half 1 mg tablet) per day for 12 weeks.
15740684|NCT04936854|Drug|Methylprednisolone|500 mg Methylprednisolone intravenously once a week for 6 weeks, followed by 250 mg once a week for 6 weeks. Total period of treatment 12 weeks.
15740685|NCT04936841|Drug|NKTR-214|Bempegaldesleukin (NKTR-214) is an immunotherapeutic protein prodrug specifically designed to activate the patient's immune system for the treatment of cancer by providing a controlled, sustained signal to the interleukin-2 (IL-2) receptor pathway (pharmacological classification: immunostimulatory interleukin cytokine)
15740686|NCT04936841|Drug|anti-PD-1 therapy|immunotherapy drug, monoclonal antibody
15740687|NCT04936841|Radiation|Palliative Radiation|radiation to relieve symptoms
15740688|NCT04936828|Other|iCBT-based EMI|Consists of brief iCBT for psychological support (mandatory), stroke care education (optional), and nurse-led real-time chat-based support messages, delivered according to participants' preferences.
15740689|NCT04936815|Diagnostic Test|Transthoracic echocardiography|Transthoracic echocardiography for the detection of congenital or acquired structural heart disease.
15740690|NCT04936802|Device|Transcatheter tricuspid valve repair system (Trialign)|To assess the Trialign System to treat subjects with moderate to severe tricuspid regurgitation
15740691|NCT04936789|Device|IMES|Surgical implantation of IMES
15740692|NCT04936776|Behavioral|Text messaging|Text parents of children (age 0-2yrs) who are due and due soon for a vaccine across the entire NYU-Brooklyn FHC network to increase vaccination rates.
15740693|NCT04936763|Device|Janesse 20 (Cross-linked Hyaluronic Acid)|Janesse 20 will be administered at baseline (visit 2, day 0) and, if the Investigator will evaluate necessary, also at day 30 (visit 3). The Investigational device will be injected with retrograde technique (moving backward) with homogeneous amount on the length of each side of Labia Majora. The Janesse 20 dosage administered will be 1 ml in left labia and 1 ml in right labia for each session.
15740694|NCT04936750|Other|Analysis of body composition|The cross section of the third lumbar spine in the CT scan images of the patients was analyzed to obtain the parameters related to the body composition of the patients
15740695|NCT04936737|Dietary Supplement|Beta-alanine supplementation|The supplementation will be administrated in the dosage of 20mg.kg-1. On the first and the sixth (last one), one dose of beta-alanine will be taken. On the other four days of supplementation, the volunteers will take 2 doses (20mg.kg-1) of Beta-alanine.
15740696|NCT04936737|Other|High intensity interval exercise|The HIIE sessions will consist of 10 series of 1 min of effort, divided into two blocks of 5 series each. There will be an interval of 5 min of passive recovery; within each block, the interval between sets will be 1 min of active recovery. The exercise will be conducted in a mechanical brake cycle ergometer, with load applied by placing washers on a load plate (Biotec 2100, Cefise, Brazil).
15740697|NCT04936724|Other|Pictorial Warning Labels|Participants will be randomized to one of two conditions and will view 4 pictorial warning labels from the assigned group for an eye-tracking task.
15740698|NCT04936711|Device|Resteck Shiatsu Neck and Back Massager|back massager device sold on the market that can readily be purchased online or in store
15740699|NCT04936711|Drug|Marcaine|Marcaine spray at incision site after closure
15740700|NCT04936698|Drug|PTU 50 MG Oral Tablet|to treat if the patient has hyperthyroidism
15740701|NCT04936698|Drug|Levothyroxin|to treat if the patient has hypothyroidism
15740702|NCT04936685|Biological|Meningococcal Polysaccharide (Serogroups A, C, W, and Y) Tetanus Toxoid Conjugate Vaccine|Liquid solution for injection Intramuscular
15740703|NCT04936672|Behavioral|Brisk walking and Tai Chi Chuan|This study includes four groups, the three experimental groups are brisk walking group, Tai chi chuan group, brisk walking combined with Tai chi chuan group, and control group. Among the three experimental groups and exercise time, exercise intensity and exercise frequency are the same over time.
15740704|NCT04936659|Other|neuromodulation|Palpatory neuromodulation of the V1 and V2 branches of the trigeminal nerve where they exit onto the face.
15740705|NCT04936646|Device|RepetitiveTranscranial Magnetic Stimulation (rTMS)|The rTMS protocol consist of one session per day for five days during the first week, then three sessions the second week and then one session the third week, followed by two monthly sessions.
15740706|NCT04936633|Other|Intervention by medical staff based on a cloud system|"Remote intervention by medical staff (between Visit 1 and Visit 2; Week 2, 4, 6, 8, 10) : analyzing continuous glucose monitoring data for last two weeks in the cloud system
~- Intervention contents
~Diet, exercise pattern
~Causes of hypoglycemia
~Causes of hyperglycemia
~Causes of glycemic variability
~Counseling for improvement plans for the cause
~Counseling to strengthen lifestyle modification
~Counseling for insulin administration
~Counseling for Insulin dose adjustment (adjusted dose)
~Counseling for how to use a FSGM"
15740707|NCT04936620|Procedure|Duroplasty|Expansion Duroplasty
15740708|NCT04936620|Procedure|Spinal surgery|Spinal surgery including laminectomy
15740709|NCT04936607|Procedure|Personalized hydration strategy|In the experimental group, NS infusion rate will be adjusted based on LVEDP for the whole duration of the procedure (<13 mmHg: 5 ml/kg/h; 13-18 mmHg: 3 ml/kg/h; >18 mmHg: 1.5 ml/kg/h), or for one hour, whichever is the longest. After the procedure, and for a duration of 4 hours, the hydration rate will be adjusted based on the (contrast volume:estimated glomerular filtration rate (eGFR)) ratio, according to the following scheme: 1.5 ml/kg/h if contrast volume/eGFR ratio <2.0; 3 ml/kg/h for contrast volume/eGFR ratio 2.0-2.9; 5 ml/kg/h for contrast volume/eGFR ratio ≥3.0.
15740710|NCT04936607|Procedure|Standard of care|In the control group, infusion rate will be of 1.5 ml/kg/h during the procedure, and for the 4 following hours.
15740711|NCT04936594|Device|iTBS|1800 pulses of iTBS
15740712|NCT04936594|Device|Sham TMS|Sham TMS
15740713|NCT04936581|Procedure|Open Total Mesorectal Excision|Open approach for Total Mesorectal Excision
15740714|NCT04936581|Procedure|Laparoscopic Total Mesorectal Excision|Laparoscopic approach for Total Mesorectal Excision
15740715|NCT04936581|Procedure|Robotic Total Mesorectal Excision|Robotic approach for Total Mesorectal Excision
15740716|NCT04936581|Procedure|Transanal Total Mesorectal Excision|Transanal approach for Total Mesorectal Excision
15740717|NCT04936568|Other|Palliative Care Referral System - PCRS|Implementation of a system to help oncologists to identify criteria for referring patients to specialized outpatient palliative care (Palliative Care Referral System - PCRS)
15740718|NCT04936555|Other|Self-Acupressure|Acupressure is a therapy method performed with an instrument or hand, fingertip, palm, elbow, knee, thumb relaxation and wrist bands on various points representing the waist organs in order to ensure the continuation and balance of the energy in our body.
15741881|NCT04926844|Drug|Midazolam|Intravenous midazolam 0.2 mg/kg (maximum 10 mg) over 2 minutes
15740721|NCT04936529|Dietary Supplement|β-glucan|"Group 1 participants receive oral β-glucan (40 mg/kg/day) starting week 1 and continue with ~2 weeks on, ~2 weeks off, up to 1 cycle after vaccination #7, then 1 cycle with each subsequent vaccination (#8-#14). This schedule includes annual booster vaccinations, with a 2-week cycle of β-glucan, administered at months 36 (3 years), 48 (4 years), and 60 (5 years).
~Group 2 participants receive oral β-glucan (40 mg/kg/day) starting week 1 and continue with ~2 weeks on, ~2 weeks off, up to 1 cycle after vaccination #7, then 1 cycle with each subsequent vaccination (#8-#14).
~Group 3 participants will be treated as in Group 1."
15740722|NCT04936529|Drug|GM-CSF|"Group 1 participants will not receive GM-CSF.
~Group 2 participants will receive GM-CSF (250 mcg/m2/day) x3 days with vaccinations #1-#3; x7 days with vaccinations #4-#11; and x5 days with vaccinations #12-#14.
~Group 3 participants will be treated as in Group 1."
15740723|NCT04936529|Biological|OPT-821|Vaccine injections must occur a minimum of 6 days apart. After the first four vaccine injections, vaccines can be administered up to two weeks earlier or later than indicated without representing a protocol violation.
15740725|NCT04936503|Diagnostic Test|Resting electrocardiogram|An ECG at rest is performed for all participants at Day 0. A centralized reading is performed by one of the 6 expert cardiologists participating in the research.
15740726|NCT04936503|Diagnostic Test|Stress test|In case of positive COVID-19 serology and/or positive COVID-19 RT-PCR and/or new ECG abnormality and/or positive questionnaire, a stress test is performed.
15740727|NCT04936503|Diagnostic Test|Cardiac echocardiography|In case of positive COVID-19 serology and/or positive COVID-19 RT-PCR and/or new ECG abnormality and/or positive questionnaire, a Cardiac echocardiography is performed.
15740728|NCT04936503|Diagnostic Test|Cardiac rhythm monitoring|In case of positive COVID-19 serology and/or positive COVID-19 RT-PCR and/or new ECG abnormality and/or positive questionnaire, a Cardiac rhythm monitoring is performed.
15740729|NCT04936503|Other|Questionnaire|To determine the rhythmic risk of athletes
15740730|NCT04936503|Device|Injected Cardiac MRI|"High resolution MRIs is performed on 200 athletes :
~100 athletes without rhythmic abnormalities (50 individuals with positive COVID-19 status and 50 individuals with negative COVID-19 status)
~100 athletes with rhythmic abnormalities (50 individuals with positive COVID-19 status and 50 individuals with negative COVID-19 status)"
15740731|NCT04936503|Biological|Blood sampling for biobank|"For all athletes included at the D0 inclusion visit, a centralized COVID-19 serology is performed to search for biomarkers associated with the occurrence of myocardial fibrosis: analysis of genetic determinants in relation to cardiac damage.
~For athletes who have performed MRI: Search for biomarkers associated with the occurrence of myocardial fibrosis: analyses of low-grade inflammation markers (cytokine assay and fibrosis markers)."
15740734|NCT04936477|Other|Calculation of ventilation-perfusion ratio|"Three to five paired measurements of fraction of inspired oxygen and peripheral oxygen saturations.
~Insertion of mainstream capnograph with combined pressure and flow sensor to perform end-tidal capnography measurement.
~Echocardiogram to assess intra-cardiac shunting."
15740735|NCT04936464|Device|transcutaneous tibial nerve stimulation (TTNS)|TTNS is a non-invasive, surface electrode therapeutic stimulation technique available for home administration that has been proposed as a treatment for overactive bladder.
15740736|NCT04936464|Device|transcutaneous electrical stimulation (TENS)|The sham intervention is designed to appear almost identical to the TTNS intervention.
15740737|NCT04936451|Device|TENS (transcutaneous electrical nerve stimulation)|"Patients will benefit from screening for refractory pain, neuropathic or not, with myofascial syndrome, between 3 and 12 months after surgery.
~The healthcare professional will determine 4 trigger points. TENS is applied twice 45 min every day for 2 months. Pain treatment will be done by using the P6 program in alternative mode: 2hz / 100Hz.
~The time between 2 electrostimulations will be a minimum of 4 hours and a maximum of 15 hours."
15740738|NCT04936451|Device|TENS (transcutaneous electrical nerve stimulation) ECOMODYN|"TENS ECOMODYN® is applied to 4 treatment points, 5 minutes per point 2 times a day for 2 months.
~A minimum rest period of 4 hours between 2 sessions on the same point must be respected Stimulation is performed directly with the bipolar probe of the TENS ECOMODYN® device on the painful area by fixed stimulation of 4 active pain points in 77Hz mode."
15740739|NCT04936425|Device|OTSC Stentfix|The OTSC stentfix will be placed during upper endoscopy after a self-expanding metal stent has been deployed.
15740740|NCT04936412|Device|Rehabilitation brace|Rehabilitation brace
15740741|NCT04936399|Biological|Nivolumab|Participants will receive Nivolumab after prior chemotherapy as part of an early access to medicines scheme (EAMS) program in the United Kingdom (UK)
15740742|NCT04936386|Behavioral|Survey|The survey is composed of 4 different sections: the first section included questions about demographic data of participants; the second part evaluated responders' knowledge about FGM; the third section focused on participants' working experience with patients affected by FGM and personal attitude related to this topic.
15740743|NCT04936360|Other|questionnaires for clinical assessments|questionnaires for clinical assessments
15740744|NCT04936347|Procedure|cold knife|Transcervical resection of adhesions is performed with scissors to restore the shape of uterine cavity, promote the regeneration and repair of endometrium, and ultimately improve the reproductive prognosis of patients.
15740745|NCT04936347|Procedure|hot knife|Transcervical resection of adhesions is performed with bipolar electric cutting to restore the shape of uterine cavity, promote the regeneration and repair of endometrium, and ultimately improve the reproductive prognosis of patients.
15740746|NCT04936334|Diagnostic Test|68Ga-PSMA-11 PET Scan|Patients will undergo injection of 68Ga-PSMA-11 at the time of their pre treatment PSMA PET scan and followed until 12 months post surgery.
15740747|NCT04936321|Behavioral|Internet-delivered CBT for Insomnia|The program delivers the core components of CBT for insomnia including sleep hygiene, stimulus control, and sleep restriction. Treatment duration is 6 weeks.
15740748|NCT04936321|Behavioral|Internet-delivered CBT for Pain Management|The program delivers the core components of CBT for pain management including: pain education, training in behavioral and cognitive pain coping skills, instruction in increasing activity participation, and training in parental operant and communication strategies. Treatment duration is 6 weeks.
15765223|NCT04734678|Drug|Infliximab|5 mg/kg/day IV for 2 doses 12-24 hours
15740752|NCT04936295|Drug|Fulvestrant plus Anlotinib|Each patient receives Fulvestrant (500mg delivered by intramuscular injection every 4 weeks) plus Anlotinib(20mg taken orally for 14 days and stop for 7 days in one cycle)
15740753|NCT04936282|Drug|Grafalon|When Borderline lesions are present in protocol biopsy, administer Grafalon ® 6 mg/kg/day in a single day.
15740754|NCT04936282|Drug|Normal Treatment: Steroids, tacrolimus and mycophenolate|When Borderline lesions are present in protocol biopsy, administer treatment according to routine clinical practice
15740755|NCT04936256|Device|Clareon|Clareon monofocal intraocular lens (IOL)
15740756|NCT04936243|Behavioral|FOLLOW UP VISIT-TELEMEDICINE|Routine follow up care conducted remotely with video-conferencing tools
15740757|NCT04936243|Behavioral|FOLLOW UP VISIT-FACE TO FACE|Routine follow up care conducted in person
15740762|NCT04936217|Other|Data collection|For each patient, the following data will be collected and analyzed: age at operation, sex, Body Mass Index (BMI), ASA score, ASIA score, type of bladder dysfunction assessed by urodynamic evaluation, urinary abnormalities assessed by morphological examination (ultrasound and / or computed tomography) and cystoscopy, creatinine clearance, operative indications, initial mictional mode, surgical assembly, immediate and later complications.
15740763|NCT04936217|Other|Interview using a validated questionnaire|A telephone survey will be conducted by means of a questionnaire in order to evaluate the patient's quality of life.
15740764|NCT04936204|Device|ConnettivinaBio Plus cream|The Un-blinded Investigator will perform the first application of medication. He will also instruct the patient or his/her caregiver to the self-application of the treatment which will be covered by a secondary dressing according to the site's standard care.
15740765|NCT04936204|Device|ConnettivinaBio cream|The Un-blinded Investigator will perform the first application of medication. He will also instruct the patient or his/her caregiver to the self-application of the treatment which will be covered by a secondary dressing according to the site's standard care.
15740766|NCT04936191|Device|DynamX Bioadaptor Drug-eluting Stent|Patients received percutaneous coronary intervention in a similar way to a traditional DES. Patients first receive radial artery or femoral artery cannulation with anticoagulation during the intervention. All coronary angiograms are carefully measured by at least 2 orthographic views and performed under the same standard conditions. After adequate predilatation of the target lesion, the coronary stenting will be performed. All patients will receive a loading dose of acetylsalicylic acid and a P2Y12 inhibitor pre-procedure followed by dual antiplatelet therapy for at least 6 months.
15740767|NCT04936178|Drug|NB003 tablets|NB003 tablets will be administered orally twice daily for repeated 28-day cycles until discontinuation criteria are met.
15740768|NCT04936165|Procedure|Low-Level Laser Therapy|Use 810-nm-photosource to irradiate the participants' brain and forearm for 10 minutes with a water-cooling radiator to keep it at 25 ± 0.5 ℃.
15740769|NCT04936152|Other|mime therapy using tablet PC mirror application|"After the baseline assessment, The patient in the experimental group will receive mirror therapy and mime therapy.
~Exercises time period is 30 min/session
~Mime Therapy Using Tablet PC:
~Mirror therapy using tablet PC mirror application We will use a tablet PC mirror application that can convert images from right to left. In the mirror group, the mirror application was used during the exercise. Patients watched the tablet PC screen. The mirror application converts the image from right to left.
~• Mime therapy include Mime therapy will consists of auto massage- effleurage and kneading for 10 to 15minutes on both the sides of the face, stretching exercises of the muscles of the affected side followed by facilitation, specific low intensity exercises to co-ordinate both the halves of the face, active assisted exercises for affected side of the face, exercises of mouth and eye with simultaneous inhibition of synkinesis if present."
15740770|NCT04936152|Other|the control intervention including the mime therapy|After the baseline assessment, The patient in the experimental group will receive mime therapy Mime therapy include Mime therapy will consists of auto massage- effleurage and kneading for 10 to 15minutes on both the sides of the face, stretching exercises of the muscles of the affected side followed by facilitation, specific low intensity exercises to co-ordinate both the halves of the face, active assisted exercises for affected side of the face, exercises of mouth and eye with simultaneous inhibition of synkinesis if present.
15740771|NCT04936139|Behavioral|Art Therapy|"During the 12 planned sessions, different artistic disciplines will be used: visual arts, music, play, narrative, dramatization, movement and body expression.
~Each session is structured in 3 phases:
~i. A first part of encounter and contextualization, to make contact with oneself, with the art therapist and with the group through a relaxation or meditation activity (35 minutes).
~ii. A second part, where the session continues with the work of artistic elaboration and production with the different materials and the different artistic languages (50 minutes).
~iii. A third part where the participants will be invited to make a closing, a moment to welcome and share whoever wishes, the experiences that have been experienced. A dialogue is created between Work-Patient-Art Therapist (35 minutes)."
15740772|NCT04936126|Drug|Quetiapine|Quetiapine XR 100 mg/day augmentation to the ongoing Sertraline treatment for the study period
15740773|NCT04936126|Drug|Amantadine|Amantadine 200 mg/day (in two divided doses) augmentation to the ongoing Sertraline treatment for the study period
15740774|NCT04936126|Drug|Pramipexole|Pramipexole 0.375 mg/day (in three divided doses) augmentation to the ongoing Sertraline treatment for the study period
15740776|NCT04936100|Device|"Assessment of distance and near visual acuity using Vision Screening module of Easy Vision application"|"The presenting visual acuity will be assessed using the Vision Screening module of the Easy Vision application."
15740777|NCT04936100|Device|"Assessment of distance and near visual acuity using Test Yourself module of Easy Vision application"|"The presenting visual acuity will be assessed using the Test Yourself module of the Easy Vision application."
15740778|NCT04936100|Device|"Assessment of distance and near visual acuity using Peek Acuity application"|"The presenting visual acuity will be assessed using the Peek Acuity application."
15740813|NCT04935801|Biological|HD PepGNP-Dengue|Two intradermal injections in the upper arm spaced 21 days apart
15740814|NCT04935788|Dietary Supplement|milk protein|milk protein supplement
15740779|NCT04936100|Other|Assessment of distance and near visual acuity using the conventional methods|"The presenting visual acuity will be assessed using the conventional methods [Chart: Tumbling E optotype for assessing distance visual acuity and Handheld chart: Tumbling E Near Point Vision Chart for assessing near visual acuity]"
15740780|NCT04936087|Other|The World Health Organization 8 steps for manual wheelchair service delivery|"All study participants were provided with a new wheelchair, a wheelchair cushion, and wheelchair services, delivered by trained wheelchair service providers, according to the WHO 8-step wheelchair service delivery process including assessment, fitting, and a 30-minute individual or group training on 7 wheelchair skills, device care, and pressure injury prevention techniques. Additionally, wheelchair maintenance reminders were sent through a text message service (SMS) to a sub-cohort of participants.
~Wheelchair users were provided with one of three different, International Standards Organization (ISO) tested, wheelchair models according to the users' needs and availability: standard, active, and all-terrain models. All wheelchairs were provided with a basic contour cushion made of polyurethane foam. However, whenever a risk of pressure injury was identified for a study participant, wheelchair providers fabricated a pressure-relief cushion."
15740781|NCT04936074|Procedure|Muscle preserving selective laminectomy|Muscle-preserving selective laminectomy differ from traditional laminectomy by the spinous process split that preserves the deep extensor muscles. The bilateral facet joints are not exposed. After the laminectomy is finished the split fragments of the spinous process are sutured together so that the deep extensor muscles are restored.
15740782|NCT04936074|Procedure|Posterior decompression with instrumented fusion|A traditional laminectomy is complemented with lateral mass and/or pedicle screws connected with rods.
15740783|NCT04936061|Device|CoolStat active device|The CoolStat active device will administer a therapeutic flow of dry air into the nostril.
15740784|NCT04936061|Device|CoolStat sham device|The CoolStat sham device will administer a sham flow of ambient air into the nostril.
15740785|NCT04936048|Behavioral|Music Therapy|Music therapy will use rhythmic cues, music instruments (piano, drums, djembe, xylophone, harmonica), songs, and stories accompanied by songs or musical instruments to target common goals.
15740786|NCT04936048|Behavioral|Play therapy|Play therapy is designed as a play-based active comparison condition to control for factors such as support, therapist attention, positive expectancies, and emotional engagement. It will use verbal interaction, toys (Lego, finger puppets, Play Doh, puzzles), and the same stories as in MT, but without a musical component, to target common goals.
15740789|NCT04936022|Other|Isometric Exercise|Prescribed 6 months of isometric exercise training (three sessions per week, comprised of 4 x 2-minute bouts with 2-minute recovery periods in-between).
15740790|NCT04936022|Behavioral|Standard care lifestyle advice|Healthy lifestyle advice for hypertension, given by a healthcare professional.
15740791|NCT04936009|Behavioral|Transcranial Magnetic Stimulation (TMS)|Subjects will receive both active and sham TMS in a randomized crossover assignment involving two study sessions
15740792|NCT04935996|Device|Pleuropulmonary echography|Pleuropulmonary echography is performed, in addition of the chest X-ray already performed in routine care
15740793|NCT04935983|Other|High CHO|Diet with high carbohydrate content
15740794|NCT04935983|Other|Low CHO|Diet with low carbohydrate content
15740795|NCT04935970|Diagnostic Test|diagnostic blood test|vitamin D deficiency/insufficiency reveal, hyperhomocysteinaemia reveal
15740796|NCT04935970|Diagnostic Test|neuropsychological test|neuropsychological test, including tas-26 scale, Beck's Depression Inventory, Spielberg-Hanin'scale.
15740798|NCT04935931|Drug|Naltrexone|naltrexone 50 mg PO x 1
15740799|NCT04935918|Device|ACT|Implantation of ACT balloon, Uromedica (Irvine, CA, USA) periurethrally at the bladder neck. The ACT system is a permanent implant designed for the correction of incontinence in patients.
15740800|NCT04935905|Device|Mechanical Insufflator-Exsufflator|This device augments a cough by applying a positive pressure via the upper airway or tracheostomy to increase lung volume to maximal inspiratory capacity, followed by a rapid and quick change to negative pressure to increase expiratory flow and simulate normal cough mechanism
15740801|NCT04935892|Behavioral|Slippers|Patients in the intervention group wear slippers when out of bed
15740802|NCT04935879|Drug|Inclacumab|Inclacumab will be supplied in single use 10 mL vials at a concentration of 50 mg/mL. One vial contains 500 mg of inclacumab. This is a liquid concentrate for IV infusion.
15740803|NCT04935879|Drug|Placebo|Placebo will be supplied in single use 10 mL vials containing the same ingredients without the active drug. Placebo will be prepared as a liquid concentrate for IV infusion and administered in the same manner as active study drug
15740804|NCT04935866|Other|Near-infrared spectroscopy (NIRS)|Non invasive brain oxygenation monitoring with Near-Infrared Spectroscopy (NIRS) technology. Patients enrolled in the NeurO2 study will have bilateral NIRS sensors applied to the forehead according to manufacturer recommendations. Data will be monitored continuously throughout the study intervention in the parent trials (HEMOTION and SAHaRA trials) in the neurocritical care unit. Data will be extracted from the device at the end of the study period.
15740805|NCT04935840|Dietary Supplement|FertyBiotic Pregnancy|DHA, folic acid, Iodine, iron, Lactobacillus rhamnosus, Lactobacillus reuterii, magnesium, zinc, vitamin D3, Vitamin C, Vitamin E, Group B vitamins and Biotin
15740806|NCT04935840|Other|Control|400 mcg of folic acid
15740807|NCT04935827|Other|Season of Year|"We stratify patients into 4 groups based on the season of the year (between 12/1/2007-11/30/2017)
~Winter: December, January, February
~Spring: March, April, May
~Summer: June, July, August
~Fall: September, October, November"
15740808|NCT04935827|Other|Hospitalized 14 days prior to dialysis|"We further stratify patients into 3 groups based on whether they were hospitalized within 14 days prior to dialysis
~Group 1: No hospitalization prior to dialysis
~Group 2: Hospitalized within 14 days prior to dialysis for an acute infectious respiratory condition or one of the following acute cardiac conditions (arrhythmia, myocardial infarction, stroke, or fluid overload)
~Group 3: Hospitalized within 14 days prior to dialysis for a condition not in Group 2"
15740809|NCT04935814|Drug|Vasopressin, Arginine|Once vasopressin infusion started, patients positions will be randomized: Trendelenburg (-30°), anti Trendelenburg (+30°) and supine position (0°).
15740820|NCT04935749|Device|Ultra wide-field retinal imaging|Diabetic patients will be imaged with an ultra wide-field retinal imaging device (Optos, California). Patients will be imaged either with or without mydriasis.
15740821|NCT04935736|Device|root canal sealer : CORTISOMOL SP|The participant will be treated with CORTISOMOL SP sealer in combination with gutta percha.
15740822|NCT04935736|Device|root canal sealer : SEALITE REGULAR|The participant will be treated with SEALITE REGULAR sealer in combination with gutta percha.
15740823|NCT04935723|Other|Reiki|The study was conducted as a three-group interventional randomized controlled trial to examine the effect of Reiki touch therapy on surgical fear, pain, anxiety and vital signs in patients undergoing open abdominal surgery. Reiki was applied to the first group and sham reiki to the second group. Group 3 formed the control group.
15740826|NCT04935697|Device|nVNS|3x daily treatment of nVNS + SOC
15740827|NCT04935697|Other|SOC|Standard of care patient management.
15740828|NCT04935684|Drug|Fecal Microbiota Transplantation|"Patients randomized in the FMT group will received FMT within 4 weeks following neutrophils recovery after the allo-HSCT procedure. The stool transplant will be done by enema. The day before FMT, patient will undergo bowel cleansing by ingestion of two liters of polyethylene glycol solution. The day of FMT, a colon cleanse enema will be performed in the morning and FMT will be delivered around two hours after the cleanse enema. This colic preparation is essential to optimize the results of FMT.
~The enema (50g of stools diluted in 250mL of NaCl 0.9%) will be performed by a qualified member of the study team (nurse) by using a rectal cannula (within 6 hours of thawing). The enema will have to be kept by the patient for as long as possible and at least 30 minutes."
15740829|NCT04935671|Dietary Supplement|chamomile tea n saffron|20 mg of chamomile and 1 mg saffron in a teabag given twice daily for a month in combination with allopathic treatment for depression.
15740830|NCT04935658|Device|Hypnotic relaxation induced by virtual reality (device)|A virtual reality device will be install on the patient 3-5 minutes before the beginning of the oocyte retrieval. The device will be wearing by the patient during the entire intervention and 2 minutes after the end of the ponction.
15740831|NCT04935658|Drug|local anesthesia|standard anesthesic procedure
15740832|NCT04935645|Behavioral|Progressive Muscle Relaxation|PMR is a technique that provides relaxation in the whole body by voluntary and regular relaxation of large muscle groups in the human body, which is included in mind-body applications.
15740833|NCT04935632|Behavioral|prevention training|Evaluate the impact of hypothermia prevention training on the proportion of patients hypothermic patients in the operating room
15740834|NCT04935619|Behavioral|Contingency Reinforcement|Subjects will be randomly assigned on a 1:1 ratio to either the Contingency Reinforcement or Non-Contingency Reinforcement Intervention prior to their in-person screening visit.
15740835|NCT04935619|Behavioral|Non-Contingency Reinforcement|Subjects will be randomly assigned on a 1:1 ratio to either the Contingency Reinforcement or Non-Contingency Reinforcement Intervention prior to their in-person screening visit.
15740836|NCT04935606|Behavioral|Usual Care|Usual Care participants will receive their standard medical care as usual and all study assessments. Providers will not receive information about their drug use. To reduce Hawthorne effect biases and to mask the study's purpose, RAs will provide the Usual Care arm patients with a cancer screening booklet and have them view a cancer screening Video Doctor. Participants will receive re-contact calls (5 min) to provide attentional control for the Usual Care arm, motivate continued trial participation by reminding next research assessment and study incentives, update contact information, and address participation barriers, but do not provide intervention. At study end, Usual Care will receive the QUIT video doctor and drug use reduction booklet materials including overdose prevention materials and a list of clinic/community resources to help them reduce substance use.
15740837|NCT04935606|Behavioral|QUIT Intervention (doctor brief advice, video doctor, health coaching sessions at 2- and 6-weeks)|"QUIT's core components include:
~patient screening with the WHO Alcohol Smoking and Substance Involvement Screening Test (ASSIST, score 4-26);
~face-to-face brief clinician advice on reducing drug use (2-3 minutes);
~video doctor reinforcing the clinician message;
~drug use reduction brochure;
~2- and 6-week telephone health coaching sessions to enhance self-efficacy in reducing drug use, via motivational interviewing and cognitive behavior therapy (CBT) techniques (20-30 minutes)."
15740838|NCT04935606|Behavioral|QUIT-Mobile (QUIT Intervention plus weekly mobile-web app or text message weekly self-monitoring, automated feedback over 12 months)|"The QUIT-Mobile intervention includes QUIT's core components and adds:
~SMS/IVR/mobile-app self-monitoring survey prompts twice-weekly during the QUIT coaching through 6 weeks, and then weekly self-monitoring and automated feedback via SMS/IVR/app through 12-months.
~Web-based dashboards will be used by coaches for monitoring of patients' self-monitoring data to enhance 2- and 6-week coaching sessions and for monitoring during the post-coaching self-management and monitoring period from 7-weeks to 12-months and intervening accordingly. The mobile platform will provide the same intervention functions (self-monitoring surveys and feedback messages) and robust data transfer protocols across three mobile technology platforms."
15740839|NCT04935593|Other|The RENEW Intervention|An game-based intervention that will provide lessons and activities in social-awareness, self-management, self-awareness, relationships and decision making in effort to strengthen social, emotional and behavioral competence. The intervention will be administered tri-weekly for 20 minutes each session.
15740840|NCT04935580|Biological|GC012F injection|GC012F injection is an autologous dual CAR-T targeted BCMA and CD19. A single infusion of CAR-T cells will be administered intravenously.
15740841|NCT04935567|Other|Statistical model for the prediction of VNS efficacy|statistical model for the prediction of VNS efficacy based on a mathematical and statistical analysis of scalp EEG data
15740842|NCT04935554|Other|Person centred care|physical activity, nutrition, motivation, health competence, psychosocial.
15740843|NCT04935541|Drug|Dexmedetomidine infusion|After Dexmedetomidine infusion was given for 10 minutes, local anesthesia was applied by the surgeon. Peribulbar block and periorbital infiltration application were performed by applying a mixture of lidocaine (Jetokain, Adeka, Turkey) and 1/200000 adrenaline. After the local anesthetic agent was applied by the surgeon, orbital compression was provided for 5 minutes with maximum pressure to block the eyelid movements. Cataract surgery procedures of all patients included in the study were performed by the same surgeon.
15740844|NCT04935541|Drug|Remifentanil infusion|After Remifentanil infusion was given for 10 minutes, local anesthesia was applied by the surgeon. Peribulbar block and periorbital infiltration application were performed by applying a mixture of lidocaine (Jetokain, Adeka, Turkey) and 1/200000 adrenaline. After the local anesthetic agent was applied by the surgeon, orbital compression was provided for 5 minutes with maximum pressure to block the eyelid movements. Cataract surgery procedures of all patients included in the study were performed by the same surgeon.
15740845|NCT04935528|Biological|serology and ELISPOT test|27 mL blood sample to study the humoral and the cellular immune response
15740846|NCT04935528|Biological|serology|7 mL blood sample to study the humoral response
15740847|NCT04935515|Drug|Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins|Oral Azithromycin , Cetirizine, Paracetamol, Zinc, Vitamin C, Vitamin D
15740848|NCT04935515|Drug|Oral low dose steroid|Low dose oral methyl prednisolone was added.
15740849|NCT04935515|Drug|Intravenous Antibiotics with Low dose steroid.|Intravenous ceftriaxone with either oral methyl prednisolone or intravenous dexamethasone was given
15740850|NCT04935515|Drug|Oral anti-coagulant|Rivaroxaban was given for minimum 4 weeks depending on D dimer levels
15740851|NCT04935502|Other|Home based exercises with postural and ergonomic training|Group A will be treated with stretching and strenghtening exercises for 40 minutes along with postural and ergonomic training for 15 minutes session 3 days/week for 4 week.
15740852|NCT04935502|Other|Home based exercises|Group B will be given stretching and strengthening exercises for 40 minutes, every alternate day (3 days per week) for 4 weeks.
15740853|NCT04935489|Device|Intermittent Theta Burst Stimulation (form of repetitive transcranial magnetic stimulation) given in an accelerated form|The intervention is used regularly for patients with treatment resistant depression, however, in this trial it will be given multiple times per day and over less days than the usual protocol
15740854|NCT04935476|Drug|Dapsone 85 mg PO BID|Participants will receive standard of care and study medication Dapsone 85 mg per os (PO) twice daily for 21 days. If a dose is missed, it will not be replaced.
15740855|NCT04935476|Drug|Placebo 85 mg PO BID|Placebo oral tablet, twice daily for 21 days.
15740856|NCT04935450|Diagnostic Test|Bronchoalveolar lavage|Low volume Broncho alveolar lavage. During optic flexible bronchoscopy through the tracheal tube or the tracheostomy cannula a maximum of 4 aliquots of 20 ml normal saline will be instilled in a wedged position in the right medium lobe of the patients and then aspirated untill reaching a total of 25ml of fluid (BALF) for analysis
15740857|NCT04935437|Other|Supervised rehabilitation program.|The program includes aerobic exercise, strengthening exercises, physiotherapy, psychological support and dietary advice.
15740858|NCT04935424|Device|ApolloVue® S100 Image System (Apollo Medical Optics)|The device is an in vivo non-invasive optical coherence tomography and will be used to obtain at least 6 medical images of normal and lesional skin, respectively, for both experimental group and control group. The ApolloVue S100 image system is a high resolution OCT imaging system that provide real-time visualization of human skin tissue microstructure. The system provides cellular level, two-dimensional, cross-sectional (B-scan) and en face (E-scan) that can assist clinical diagnosis.The system is also equipped with imaging guiding system that could assist in position scanning skin area.
15740859|NCT04935411|Other|nAMD|patients diagnosed with Neovascular Age-Related Macular Degeneration
15740860|NCT04935398|Other|Physiotherapy|The aim is to test two treatment techniques against each other to see how effective they are.
15740861|NCT04935385|Other|Collecting blood specimens|Blood samples will be collected from all study participants at different required timelines
15740862|NCT04935372|Other|Observational|"Cross sectional analyses The two main variables for the analysis will be: Values of biomarker concentrations in blood and their correlations with CSF biomarkers and the development of prodromal AD for the cognitively unimpaired SCD population. Other variables of interest for the study are, among others, risk factors, cognitive status, measurements of brain structure and function, mental health, chronic diseases, environmental exposures, age and sex.
~Longitudinal analyses Longitudinal analyses will estimate the association between the intensity of the subjective complaint and the rate of progression between the diagnostic categories; The association of biomarkers, risk factors and other clinical variables with the rate of progression between the diagnostic categories; The association of cognitive and neuroimaging variables with the rate of progression between the diagnostic categories; The evolution of the complaint itself and its relation to the other variables described."
15740867|NCT04935346|Other|no intervention group|The awareness of medical and nursing students were evaluated. there is no intervention
15740868|NCT04935333|Procedure|Collection of Leiomyoma samples|"Peripheral blood will be collected from the candidate patient with suspected myometrial tumours, prior to the surgery already planned form medical indication in accordance with routine clinical practice.
~A sample of tumour tissue will be collected during surgery and sent to pathologists for diagnosis in accordance with the usual clinical practice. The tumour paraffin block/sections will be requested for the study only after the diagnosis."
15740869|NCT04935333|Procedure|Collection of Leiomyosarcoma samples|"Peripheral blood will be collected from the candidate patient with suspected myometrial tumours, prior to the surgery already planned form medical indication in accordance with routine clinical practice.
~A sample of tumour tissue will be collected during surgery and sent to pathologists for diagnosis in accordance with the usual clinical practice. The tumour paraffin block/sections will be requested for the study only after the diagnosis."
15740870|NCT04935333|Procedure|Collection of control samples|Peripheral blood will be collected during an analysis or gynaecological consultation already planned by routine clinical practice. The sample will be sent to Igenomix for molecular analysis.
15740873|NCT04935307|Diagnostic Test|MRI and paraclinical tests|The patients and controls will be evaluated using MRI and furthermore a large test battery of questionnaires and paraclinical tests. Including the following test: MCS checklist, BDS-Checklist, Symptom Checklist-92 (SCL-92), Whiteley-8, SF-36, Major Depression Inventory (MDI), GAD-10 anxiety scale, and related questionnaire, behavioral olfactory test (TDI), habituation test, pain measurement thresholds tests, Heart Rate Variability and cognitive testing.
15740874|NCT04935294|Drug|Danicopan|Oral tablet.
15740875|NCT04935281|Other|percutaneous repair with an intraoperative assisted ultrasound|Under general or regional anesthesia, the patient laid in prone position In group A, an intraoperative ultrasound was done by a radiologist before the repair .
15740876|NCT04935281|Other|percutaneous repair without an intraoperative assisted ultrasound|For patients in group B, the course of the sural nerve was determined according to the technique described by Blackmon et al.The medial and lateral borders of both stumps were outlined by palpation with identification of the gap in-between. We used the technique described byMaffulli et al with six stab incisions, one cm each. Four incisions were on medial and lateral edge of the proximal stump and the other two were around distal stump.
15740877|NCT04935255|Other|Blood sampling - Pharmacokinetic assessment|Two pharmacokinetic assessments will be performed (on day 2 and day 4). Each pharmacokinetic assessment consists of 10 samples (5 ml blood).
15740878|NCT04935229|Drug|SD-101|SD-101 doses will be delivered via hepatic artery infusion using pressure enabled drug delivery using the TriNav device
15740879|NCT04935229|Biological|Nivolumab|During Cohort B, nivolumab will be administered together with SD-101 and during Cohort C, it will be administered with ipilimumab and SD-101
15740880|NCT04935229|Biological|Ipilimumab|During Cohort C, ipilimumab will be administered together with nivolumab and SD-101
15740881|NCT04935216|Procedure|Laparoscopic|Laparoscopic resection of the pancreas has become widely accepted in the treatment of lesions which are benign or of low-grade malignancy
15740882|NCT04935203|Behavioral|Priming intervention|The priming manipulation will be embedded in one computerized experiment to test the effect of three priming interventions on people's emotional reaction and their subsequent sustainable food selection. The priming conditions include priming with health benefits, environment benefits, and co-benefits of having sustainable diets, respectively. The cueing manipulation will be achieved by asking participants to complete a word-search exercise. Brief introduction will be provided to guide participants to choose words/statements that can indicate having a health and sustainable diet can have one of the three benefits: health benefits, environmental benefits or both benefits. The exercise will take ~2 min.
15740883|NCT04935190|Diagnostic Test|Vitalpercept|Comparison of resting heart and respiratory rate measurements acquired by contactless radar sensors, electrocardiography, and capnography
15740890|NCT04935164|Other|Psychiatric evaluations|At different time points, several psychiatric evaluations will be performed on patients and volunteers for study purposes
15740891|NCT04935151|Procedure|holmium laser enucleation of the prostate|cystoscopic transurethral enucleation of the prostate using Holmium laser
15740892|NCT04935151|Procedure|Bipolar resection of the prostate|cystoscopic transurethral resection of the prostate using bipolar energy
15740893|NCT04935138|Genetic|cfDNA analysis|sequencing data from cfDNA analysis
15740894|NCT04935125|Procedure|Standard Program + Endurance and Strength training|Sessions of strength training added to a standard inpatient multidisciplinary programme
15740895|NCT04935125|Procedure|Standard Program|Standard inpatient multidisciplinary programme (including endurance training)
15740896|NCT04935112|Drug|Sitravatinib|100 mg sitravatinib on Day 1
15740897|NCT04935112|Drug|Pantoprazole|40 mg QD on Day 1 to Day 7 of Period 2 in Group 1
15740898|NCT04935112|Drug|Famotidine|40 mg PO 2 hrs after sitravatinib in Period 2 of Group 2
15740899|NCT04935099|Dietary Supplement|Wild blueberry powder|22 g freeze-dried wild blueberry (Vaccinium angustifolium) powder, mixed with 250 ml water, and served in an opaque container.
15740900|NCT04935099|Dietary Supplement|Placebo powder|22 g placebo powder matched for macronutrients and flavor, mixed with 250 ml water, and served in an opaque container.
15740901|NCT04935073|Drug|Prescription of traditional Chinese Medicine named Er Zhi Wan combined with Si Wu Tang|The medicines used in this study including Radix et Rhizoma Ligustrum 15 g, Radix Morindae Sinensis 12 g, Fructus Lycii 15 g, Semen Cuscutae 20 g, Radix Rehmanniae 15 g, Radix Angelicae Sinensis 10 g, Radix Paeoniae Alba 10 g, Ligusticum wallichii 6 g, Poria cocos 15g, Polygonatum 15g, eclipta 10g. which will be taken for 10-15days.After the ET, the treatment group will continue to take Chinese herbal medicine, changing to Shou Tai pills ( Morinda officinalis 15 g, Teasel 15g，Cuscutae 20 g, Eucommia ulmoides 15 g, Rehmannia 15 g, Cornus officinalis 15 g, loranthus parasiticus 20 g, Ligustrum lucidum 15g, Salvia miltiorrhiza 10g, Scutellaria baicalensis 10g, Atractylodes macrocephala 15g); which will be taken for 14days. The hospital will be responsible for the decoction of 200 mL per dose, 1 dose per day, divided into 2 doses in the morning and in the evening.
15740902|NCT04935073|Drug|Recombinant Human Follitropin Alfa for Injection、Fructose Injection、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate Powder for Injection|The intervention starts from the 5th day of the menstrual cycle and lasts to the day before IVF-ET.
15740926|NCT04934852|Drug|Ephedrine|When elderly patients had hypotension (invasive blood pressure drops >20% from the baseline value or <100 mmHg, or MAP <70mmHg) 20 minutes after anesthesia induction, 12 mg ephedrine in 10 ml saline was usd Intravenously
15740905|NCT04935047|Other|Multilingual Support|Multilingual Support is a classroom intervention, which is designed to be delivered in classes of adult learning of a new language. The intervention involves the use of a language assistant, who is at minimum independent user (B1) in the language to be learned (in this case Norwegian), according to the language proficiency scale of the Common European Framework of Reference (CEFR) for languages, learning, teaching, assessment (Little, 2006). The language assistant will be in the classroom for seven hours a week, collaborating with the teacher in providing language training. In classrooms where participants have different primary languages, the language assistant(s) must cover all languages represented in the classroom.
15740906|NCT04935034|Dietary Supplement|Vitamin D supplement|This intervention will compare the effect of changing the lipid component of a vitamin D enriched dairy drink on postprandial change in 25OHD concentrations.
15740907|NCT04935021|Drug|ATTR-CM|Current treatment
15740908|NCT04935008|Diagnostic Test|The recruitment maneuver|Recruitment maneuver will be performed by applying 30 cm H2O positive pressure support for 30 seconds in patients with ARDS or in patients with decreased oxygen saturation due to postoperative atelectasis. The effect of the recruitment maneuver on intracranial pressure will be investigated by measuring the optic nerve sheath diameter with the help of ultrasonography before and after the recruitment maneuver. Optic nerve diameter with a linear probe on the eyeball before and after the recruitment maneuver will be evaluated by taking the value 3mm from the eyeball. If the optic nerve sheath diameter is over 5 mm, the intracranial pressure will be considered increased.
15740909|NCT04934995|Other|Blood Pressure Cuff|"After obtaining consent and confirming eligibility, Blood Pressure cuffs will be used as specified below:
~Cuff size: large BP cuffs will be the default size for both arm and ankle measurements, but can be changed as clinically indicated based on circumferences of limbs Cuff location: BP cuffs will be placed on the contralateral arm to the main peripheral IV following standard procedures. Left ankle cuff will be placed underneath intermittent pneumatic compression cuffs Ankle blood pressure monitor screen will be covered. Thus, anesthesia providers will not be able to make any clinical decisions based on ankle blood pressures but arm blood pressure (standard) instead."
15740910|NCT04934982|Other|Total Laparoscopic or Robotic Radical Hysterectomy|Stage IA1 with lymphovascular interstitial infiltration and IA2 surgical approach was type B (modified radical hysterectomy plus bilateral pelvic lymph node dissection, i.e., resection of 1~2 cm of the parametrium and 1~2 cm of the vagina) with abdominal para-aortic lymph node dissection if necessary (surgical staging according to FIGO 2018 and surgical staging according to Querleu-Morrow staging).
15740911|NCT04934982|Other|Total Abdominal Radical Hysterectomy|Stage IA1 with lymphovascular interstitial infiltration and IA2 surgical approach was type B (modified radical hysterectomy plus bilateral pelvic lymph node dissection, i.e., resection of 1~2 cm of the parametrium and 1~2 cm of the vagina) with abdominal para-aortic lymph node dissection if necessary (surgical staging according to FIGO 2018 and surgical staging according to Querleu-Morrow staging).
15740912|NCT04934969|Dietary Supplement|Adjunctive use of lavender and peppermint essential oils|passive inhalation aromatherapy following joint surgery
15740913|NCT04934956|Other|Split-belt walking|These will be used in all experiments and consists of a time period during which the legs move at different speeds (0.5 m/s vs. 1 m/s). The investigators select those speeds since the investigators have observed in our preliminary data and published study (Sombric et al. 2017) that older individuals adapted at these speeds exhibit large deficits at motor switching when transitioning to overground walking. This large reference signal will facilitate the detection of a change in motor switching (Aim 2) following the Intervention.
15740914|NCT04934956|Other|Multiple transitions between split-belt and tied-belt walking|This intervention consists of multiple short adaptation blocks (i.e., 6 blocks of 200 strides each) interleaved with short de-adaptation blocks (i.e., 5 blocks of 200 strides of tied-belt walking each). It was designed based on several studies showing improvements in adaptation rate in young adults with a similar protocol (Malone et al. 2011; Day et al. 2018; Leech et al. 2018).
15740915|NCT04934943|Diagnostic Test|mini_FC|100 ml of Crystalloids infused over 1 minute - data recording and new baseline - FC 4 ml/kg in 10 minutes - data recording
15740916|NCT04934930|Drug|Bendamustin|Chemotherapy
15740917|NCT04934930|Drug|Obinutuzumab|Immunotherapy
15740918|NCT04934917|Device|Magnetic Resonance Imaging|Magnetic Resonance Imaging. Pain testing: Temporal summation, Pain thresholds. Assessment of symptoms: Questionnaires. All interventions are made at baseline only (1 time/subject).
15740919|NCT04934904|Drug|Ropivacaine injection|On the first day of inclusion, performed T8 bilateral ultrasound-guided erector spinae plane block and indwelling tube will be left + 0.375% ropivacaine 20ml to both sides. Patients will be given injections every 12 h for 7 days.
15740922|NCT04934878|Biological|Referral information|first visit to our hospital/transfer from another hospital
15740923|NCT04934865|Device|Patients treated for their lung cancer.|"In addition to the weekly Moovcare® Lung follow-up, patients will benefit from standard oncological follow-up at the discretion of their oncologist according to standard recommendations for 2 years. Questionnaires will be completed at different times as mentioned below on the global study scheme and Flowchart.
~In an active treatment situation, the pace of consultations will be adapted to the pace of treatment administration, according to standard recommendations. It may be lengthened in the absence of a clinical application or biological alert at the discretion of the investigator."
15740924|NCT04934852|Drug|Ephedrine|When elderly patients had hypotension (invasive blood pressure drops >20% from the baseline value or <100 mmHg, or MAP <70mmHg) 20 minutes after anesthesia induction, 4 mg ephedrine in 10 ml saline was usd Intravenously
15740925|NCT04934852|Drug|Ephedrine|When elderly patients had hypotension (invasive blood pressure drops >20% from the baseline value or <100 mmHg, or MAP <70mmHg) 20 minutes after anesthesia induction, 8 mg ephedrine in 10 ml saline was usd Intravenously
15740927|NCT04934839|Diagnostic Test|Test of standing balance (Equitest System). Test of walking in tied and split conditions on a force-sensorized split-belt treadmill.|"Tests of standing balance will be performed using the EquiTest System posturographic platform. Individuals will be requested to perform three tasks within the EquiTest battery: Sensory Organization test, Motor Control test backward/forward, Adaptation Test upward/downward.
~Gait analysis will be performed on a force sensorized split-belt treadmill. Participants will walk at increasing velocities from 0.2 m/s to the highest sustainable velocity in tied-belt condition. Velocity will be increased by 0.1 m/s every 20 consecutive strides.
~During gait analysis in the split-belt condition, participants will walk for 30 seconds with both belts at 0.4 m/s. Then, the velocity of the belt under the prosthetic limb will be increased to 1.2 m/s. After 6 minutes, the velocity of the faster belt will be restored at 0.4 m/s for 6 more minutes. Different combinations of velocities could be tested based on the patients' characteristics, maintaining a ratio of 3:1 between the velocities of the 2 belts."
15740928|NCT04934826|Dietary Supplement|Hydrolyzed Proteins|Patients in experimental arm will receive a test meal based on marked hydrolyzed proteins
15740929|NCT04934826|Dietary Supplement|Intact proteins|Patients in active comparator arm will receive a meal based on intact marked proteins.
15740930|NCT04934813|Other|Alveolar ridge preservation|application of different bone graft and sealing means after tooth extraction
15740932|NCT04934787|Device|ENMS-BSF assisted gait training|"ENMS-BSF will correct the foot-drop and foot inversion during post-stroke walking.
~Each participant will receive 20 sessions device assisted training, with an intensity of 3-5 sessions/week, 1 hr/session.
~In each session, a participant will complete the device-assisted walking on flat ground with a natural speed and with the aid of a four-pronged cane."
15740933|NCT04934774|Biological|CD7 CAR T cells|Non-gene edited anti-CD7 CAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.
15740934|NCT04934761|Procedure|Fluid challenge strategy|Patients received 2ml/kg of succinylateol gelatin within 10 min for fluid shock therapy after grouping, taking SVV as the management target. If SVV< 13% after shock therapy, the shock therapy was stopped and the infusion was maintained with 4ml/kg/h of crystal solution. If SVV ≥ 13% and ΔSV <10%, the individual would be excluded from the experiment. If SVV ≥ 13% but ΔSV≥10%, 2ml/kg of succinylateol gelatin was given again within 10 min for liquid shock therapy until SVV<13%, and 4ml/kg/h of crystal solution was maintained after reaching the target. If SVV≥ 13% after two shock treatments, they were excluded from the experiment. We excluded patients whose intraoperative bleeding ≥400ml and operative time ≥5 hours from the group.
15740935|NCT04934761|Procedure|conventional strategy|4ml/kg/h of crystal solution was maintained. We excluded patients whose intraoperative bleeding ≥400ml and operative time ≥5 hours from the group.
15740936|NCT04934748|Drug|Phenylephrine|Phenylephrine will be infused at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial.
15740937|NCT04934748|Drug|Norepinephrine|Norepinephrine will be infused at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial.
15740938|NCT04934748|Drug|Phenylephrine|Phenylephrine will be infused at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial.
15740939|NCT04934748|Drug|Norepinephrine|Norepinephrine will be infused at a rate sufficient to maintain the intraoperative MAP designated in the underlying GUARDIAN trial.
15740940|NCT04934735|Procedure|Rehabilitation program group|"The case-management rehabilitation program was conducted by a clinical social worker within the occupational medicine clinic and included several components:
~Intake by a case manager
~Referral to an occupational physician was within one week of the intake.
~Charting an occupational rehabilitation program and timing the RTW date
~Coordinating between the patients and their family, treating physicians, the employer, community services, and meeting with the patient's family - all on a needful basis.
~Provision of a guidance booklet for employers on the RTW of cardiac patients.
~The psychosocial intervention was tailored to the patient's emotional state, occupational needs, and specific requests.
~Intensive follow-up sessions aimed to ensure that the rehabilitation program was carried out as planned."
15740941|NCT04934722|Biological|Pembrolizumab|Pembrolizumab is administered as an IV infusion at 200 mg on Day 1 of each 21-day cycle for up to 35 cycles.
15740942|NCT04934722|Drug|Enzalutamide|Enzalutamide is administered orally as capsules/tablets at a dosage of 160 mg daily. Enzalutamide is administered continuously until criteria for discontinuation are met.
15740943|NCT04934722|Procedure|Androgen Deprivation Therapy (ADT)|Stable regimen of ADT (LHRH agonist or antagonist) at a dose and frequency of administration that is consistent with the local product label.
15740944|NCT04934722|Other|Placebo|Placebo infusion solution is administered as an IV infusion on Day 1 of each 21-day cycle for up to 35 cycles.
15740945|NCT04934709|Device|Active PBMT-sMF|PBMT-sMF was applied employing the Multi Radiance Medical Super Pulsed Laser MR4 console (Solon, Ohio, USA) with a LaserShower cluster probe as emitter. Six different sites of the knee extensor muscles (two medial, two lateral and two central points) were irradiated at the same time.
15740946|NCT04934709|Device|Placebo PBMT-sMF|Placebo PBMT-sMF was applied employing the Multi Radiance Medical Super Pulsed Laser MR4 console (Solon, Ohio, USA) with a LaserShower cluster probe as emitter, but without any emission of therapeutic dose. Placebo PBMT-sMF was applied at six different sites of the knee extensor muscles (two medial, two lateral and two central points).
15740947|NCT04934696|Drug|BMS-986166|Specified dose on specified days
15740948|NCT04934696|Drug|Oral contraceptive|Specified dose on specified days
15740949|NCT04934683|Procedure|Routine blood pressure control|Routine blood pressure control.
15740950|NCT04934683|Procedure|Tight blood pressure control|Tight blood pressure control.
15740951|NCT04934683|Drug|Etomidate|Anesthetic induction with etomidate.
15740952|NCT04934683|Drug|Propofol|Anesthetic induction with propofol.
15740953|NCT04934670|Drug|T-Guard|T-Guard will be administered intravenously inpatient over 4 hours every 2 calendar days on Days 0, 2, 4, and 6, at a dose of 4mg/m2 Body Surface Area (BSA).
15741260|NCT04932044|Other|Routine care|Receives routine care and provide general discharge care and nursing guidance.
15740954|NCT04934670|Drug|Ruxolitinib|Ruxolitinib will be administered orally twice a day starting on Day 0 through Day 56, at a dose of 10mg. Ruxolitinib taper can be initiated starting on Day 56 for participants responding to treatment, tapering will be done according to institutional practices.
15740955|NCT04934657|Other|no intervention|no intervention
15740956|NCT04934644|Procedure|Hyperbaric oxygen treatment|Hyperbaric oxygen treatment 90 min from start to start of decompression. The chamber is pressurized to 2,4 ATA and the patients will be breathing 100% oxygen. Treatments will be given once daily, five days a week (no treatments on weekends and holidays).
15740957|NCT04934631|Other|Recording of CBT-ED session.|Therapists will deliver treatment as usual (CBT-ED) to eating disorder patients. Therapy session will be audio recorded.
15740958|NCT04934631|Other|Assessment of CBT-ED clinician competence.|Independent raters will assess CBT-ED competence using the Cognitive-Behavioural Therapy Scale for Eating Disorders (CBTS-ED).
15740959|NCT04934618|Drug|Carelizumab Combined With Irinotecan and Apatinib|Three-drug regimen was used in second-line treatment of Advanced gastric cancer
15740960|NCT04934605|Procedure|Cochlear implantation|Cochlear implantation
15740961|NCT04934579|Drug|Rituximab|375mg/m2 intravenous infusion d1, every 3 weeks for 1 cycle, 6 cycles will be prescribed for induction therapy. 375mg/m2 intravenous infusion d1, every 8 weeks for 1 cycle, 4 cycles will be prescribed for maintenance therapy.
15740962|NCT04934579|Drug|Lenalidomide|25mg orally d1-10 every 3 weeks for 1 cycle, 6 cycles will be prescribed for induction therapy. 25mg orally d1-14,d29-42 every 8 weeks for 1 cycle, 4 cycles will be prescribed for maintenance therapy.
15740963|NCT04934579|Drug|Methotrexate|3.5g/m2 intravenous infusion for 4 hours in d1, every 21 days for 1 cycle, 6 cycles will be prescribed.
15740964|NCT04934566|Other|ECMO flow|Dynamic changes in ECMO flow and SvO2 measurement at the 3 different sites.
15740965|NCT04934553|Behavioral|Amplification of Positivity Training|12 90-minute, clinician-administered treatment sessions focused on presenting rationale and instructions for completing positive activity exercises (e.g., gratitude, acts of kindness) designed to increase positive emotions, cognitions, and behaviors.
15740966|NCT04934553|Behavioral|Cognitive-behavioral Therapy|12 90-minute, clinician-administered treatment sessions focused on strategies to alter cognitions and behavior related to alcohol use.
15740967|NCT04934540|Procedure|En bloc resection of bladder tumour|En bloc resection of bladder tumour (ERBT) is a novel surgical technique in which the bladder tumour is resected in one piece
15740968|NCT04934527|Drug|Cytotect|"The inclusion visit is conducted by the investigating nephrologist and the patient will receive their first infusion of anti-CMV Ig.
~Patients with positive CMV serology at transplantation will receive 6 infusions of 100 units per kilogram of body weight every 15 days with the first injection on the day of transplantation, i.e. at visits D0, S2, S4, S6, S8 and S10. CMV infection will be monitored by quantitative PCR on whole blood every week during 3 months and then every 2 weeks until 4 months and then at months 5 and 6, 9 and 12."
15740969|NCT04934514|Biological|IAH0968|IAH0968 is an investigational product.
15740970|NCT04934514|Drug|Gemcitabine|Gemcitabine 1000 mg/m^2 intravenous infusion
15740971|NCT04934514|Drug|Cisplatin|Cisplatin 75 mg/m^2 intravenous infusion
15740972|NCT04934501|Diagnostic Test|High-frame-rate contrast-enhanced ultrasound measurements (echoPIV)|Patients will undergo high-frame-rate contrast-enhanced ultrasound measurements, within 6 to 8 weeks after the endovascular procedure, at the vascular center of Rijnstate hospital. Prior to these measurements a venous cannula will be placed to ensure venous access for the contrast administration.
15740973|NCT04934501|Diagnostic Test|Computed tomography angiography (CTA) scan|Patients will undergo a CTA scan of the lower extremities at the Radiology dept. of Rijnstate hospital the same day as the echoPIV measurements. This CTA scan serves as a reference for the vessel geometry and stent location.
15740974|NCT04934488|Behavioral|Online Peer-Delivered 1-Day CBT-Based Workshop|It is a day-long intervention delivered in 4 modules. Each participant is given a professionally designed manual to facilitate learning. The 1st contains information on PPD etiology with a focus on modifiable cognitive risk factors (e.g., negative thoughts, maladaptive core beliefs). The 2nd module focuses on cognitive skills including cognitive restructuring. The 3rd builds behavioural skills such as problem solving, behavioural activation, assertiveness, sleep strategies, and using supports. The final module provides an opportunity for goal setting/action planning. Teaching methods include didactic sections, group exercises, and role-plays.
15740975|NCT04934475|Drug|Isatuximab|treatment with Isa-KRD during induction and consolidation , with revlimid or Iberdomide +isatuximab during maintenance phase
15740976|NCT04934475|Procedure|ASCT|ASCT for ams B, C and D during consolidation
15740977|NCT04934462|Procedure|physiotherapy|Six months physiotherapy aimed at hip stability.
15740978|NCT04934462|Procedure|arthroscopy|Arthroscopic plication of hip joint capsule.
15740979|NCT04934449|Device|Occlusal splint|Using occlusal splints during sleep for 6 weeks
15740980|NCT04934436|Other|sleeping glasses and earplug|In this study, the effect of the chronotype-appropriate nursing care on the intervention group will be examined.
15740981|NCT04934423|Device|Direct Current Transcranial Stimulation - tDCS|Active intervention
15740982|NCT04934423|Device|Sham Intervention|Direct Current Transcranial Stimulation - Sham intervention
15740986|NCT04934397|Other|Study Infant Formula|Powdered partially hydrolyzed whey (WPH) based infant formula with oligosaccharides
15740987|NCT04934384|Diagnostic Test|prehospital extended focused assessment sonography for trauma|Sonographic procedure performed in the prehospital environment aiming at evaluating peritoneal free fluid in trauma patients
15741010|NCT04934176|Other|Psychosocial scales/questionnaires|We will use three psychosocial scales/questionnaires for this patient population to gauge patients' perceptions of the impact of their paralysis and their recovery. The questionnaires will be completed by the patients at baseline, and 18 months after surgery. Moreover, we also will compare patient perceptions to the patient-related responses with clinical scoring made by the surgeons using the eFACE,6 Face-Gram/Emotrics12 software, and the 3D dynamic measures.
15740988|NCT04934371|Device|Transcranial Direct Current Stimulation (tDCS)|TDCS is a procedure that sends weak electrical currents between points on the scalp. Some of this current flows through the brain, and may induce temporary changes in brain activity lasting 30-60 minutes beyond the time of stimulation. TDCS is believed to be very low risk. TDCS has been applied in more than 4900 studies and hundreds of people to treat various neurological and psychiatric conditions, including depression, epilepsy, chronic pain and Parkinson's. In this study we will use tDCS to suppress symptom of tinnitus and hyperacusis.
15740989|NCT04934371|Device|Sham TDCS|Sham control will be administered to the same area as active TDCS
15740990|NCT04934358|Behavioral|Physical and motivational follow-up treatment|Physical and motivational follow-up treatment
15740991|NCT04934358|Behavioral|Usual care|Usual rehabilitation program
15740992|NCT04934345|Diagnostic Test|Fluid challenge|The fluid challenge consists of a bolus of 4 ml/kg of crystalloids, administered over 10 minutes.
15740993|NCT04934332|Procedure|Ultrasound|Ultrasound examination at 1 week and 5 weeks after admission.
15740994|NCT04934332|Procedure|CT scan|CT scan at 5 weeks after admission. CT scan reader will be blinded to clinical data.
15740995|NCT04934332|Procedure|Clinical examination|Weekly clinical examination from week-2 to week-5.
15740996|NCT04934319|Behavioral|Balance and Proprioceptive Training|"Step-by-step training (5 levels)
~30 minute per training
~3 times per week
~Four weeks"
15740997|NCT04934306|Other|Nasometry|Repetition of several stimuli (syllables, sentences ) in the microphones of the Nasometer
15740999|NCT04934280|Diagnostic Test|sonohysterography|saline infusion transvaginally followed by 2D transvaginal ultrasound imaging
15741000|NCT04934267|Other|Eccentric Exercise for subjects with JHS|There will be two groups, an experimental group with hypermobile individuals, and a control group with individuals that are not hypermobile with normal ranges of motion. All participants will take part in an exercise session with eccentric bicep curls based on their 1 repetition maximum (1-RM), which is the highest amount of weight that they can lift concentrically once. The independent variables are the two groups and the dependent variables are girth, resting arm angle, Pain, McGill Pain Questionnaire, and pressure pain threshold. This groups will perform 1 set of standing eccentric bicep curls order to induce DOMS.Each rep will include a timed 5 second long eccentric component without an concentric component,. The exercise will stop when the participant cannot volitionally keep up with the 5 second count. Prior to exercise, baseline measurements will be taken for all dependent variables. These measures will be taken every day at the same time of day,for the next 4 days.
15741001|NCT04934267|Other|Eccentric Exercise for Controls|There will be two groups, an experimental group with hypermobile individuals, and a control group with individuals that are not hypermobile with normal ranges of motion. All participants will take part in an exercise session with eccentric bicep curls based on their 1 repetition maximum (1-RM), which is the highest amount of weight that they can lift concentrically once. The independent variables are the two groups and the dependent variables are girth, resting arm angle, Pain, McGill Pain Questionnaire, and pressure pain threshold. This groups will perform 1 set of standing eccentric bicep curls order to induce DOMS.Each rep will include a timed 5 second long eccentric component without an concentric component,. The exercise will stop when the participant cannot volitionally keep up with the 5 second count. Prior to exercise, baseline measurements will be taken for all dependent variables. These measures will be taken every day at the same time of day,for the next 4 days.
15741002|NCT04934254|Other|Attitude Scale|26-item related to scale will construct and apply to nurses for creating scale
15741003|NCT04934241|Other|Self-Acupressure|Acupressure is a therapy method performed with an instrument or hand, fingertip, palm, elbow, knee, thumb relaxation and wrist bands on various points representing the waist organs in order to ensure the continuation and balance of the energy in our body
15741004|NCT04934228|Drug|Hydrochlorothiazide 12.5Mg Tab|"Will receive 4 week supply (35 days) of Hydrochlorothiazide Pills (12.5 mg twice a day)
~Planned use in this study
~Condition/disease indication(s): Hypertension
~Subject population: Hypertension
~Dose(s): 25 mg/day
~Administration: Oral
~Dosing regimen: 12.5 mg twice per day"
15741005|NCT04934228|Drug|Clonidine Pill|"Will receive 4 week supply (35 days) of Clonidine Pills (0.1 mg twice/day)
~Planned use in this study
~Condition/disease indication(s): Vascular function and blood flow
~Subject population: Hypertension
~Dose(s): 0.1 mg (oral)
~Administration: Oral
~Dosing regimen: 0.1 mg twice daily by mouth"
15741006|NCT04934228|Drug|Placebo|Will receive a 4 week supply (35 days) of Placebo Pills; has no active ingredients but is made to look like the study drug.
15741007|NCT04934202|Other|Teleconsultation|"Teleconsulting physicians will subject patients to a standardized questionnaire that will look for the following symptoms:
~General signs: Anorexia, fatigue, new hospitalization, weight loss,
~Respiratory signs: recent dyspnoea, chest discomfort, chest pain, new cough, abnormal lung CT scan since discharge
~Neurological signs: headache, paraesthesia, anosmia, limb paralysis
~Digestive signs: abdominal pain, diarrhoea, constipation, nausea, vomiting
~Edition 2021
~◌ Cognitive signs using the Q3PC questionnaire (10): memory loss, slowness in reasoning, activity planning or problem solving, concentration, attention difficulties"
15741008|NCT04934202|Other|Outpatient clinic|"During a day hospitalization planned during the teleconsultation, patients will benefit from the following multidisciplinary assessment.
~General clinical examination
~Assessment of the state of health
~Respiratory assessment
~Pulmonary CT assessment
~Cognitive evaluation
~Cardiological evaluation
~Renal assessment
~Immunological evaluation"
15741009|NCT04934189|Behavioral|Empowerment Self Defense Training|We have contracted with Prepare, Inc., the New York City chapter of IMPACT International to deliver the tailored ESD violence prevention intervention. IMPACT is an international ESD violence prevention organization with chapters across the United States. Prepare, Inc. will provide facilitators who have completed IMPACT's nationally standardized ESD violence prevention program requirements that include receipt of over 100 hours of training. IMPACT training is open to trans and cisgender women. The extensive training of IMPACT facilitators promotes intervention efficacy, while the risk of potential bias conferred by their experience with a pre-existing curriculum is mitigated by our community-engaged approach (i.e.,TW community members, service providers, and scientists [PI and Co-I] collectively shape the content of the final tailored ESD intervention, and TW co-facilitators will be present in every training session).
15741011|NCT04934176|Other|3D Facial Measurements|3D dynamic (objective) facial movement data will be collected first (estimated time 1 hour), followed by static 3D photographic data (estimated time 15 minutes), and then video data of the different facial animations (estimated time 15 minutes).
15741012|NCT04934163|Other|Flow rate setting of high-flow nasal cannula (initially 60L/min)|"The flow rates of HFNC(high-flow nasal cannula) is set as 60L/min(temperature:34°C).
~Initial FiO2 is 100%, which would be titrated down to the minimal level to keep SpO2 ≥ 92% within 30 minutes after extubation.
~After that, the flow rate setting is fixed for 24hrs +/- 6 hrs; then, is tapered to 30 L/min and kept for 12 more hours. Afterwards, HFNC would be changed to conventional oxygen therapy to keep SpO2≥ 92%."
15741013|NCT04934163|Other|Flow rate setting of high-flow nasal cannula (initially 40L/min)|"The flow rates of HFNC(high-flow nasal cannula) is set as 40L/min(temperature:34°C).
~Initial FiO2 is 100%, which would be titrated down to the minimal level to keep SpO2 ≥ 92% within 30 minutes after extubation.
~After that, the flow rate setting is fixed for 24hrs +/- 6 hrs; then, is tapered to 30 L/min and kept for 12 more hours. Afterwards, HFNC would be changed to conventional oxygen therapy to keep SpO2≥ 92%."
15741014|NCT04934150|Device|navigated repetitive Transcranial Stimulation|High frequency nrTMS over 13 sessions (1800-2000 pulses per session) over DLPFC and M1 cortical areas.
15741015|NCT04934137|Behavioral|WiSAT|The WiSAT system uses a force-sensing mat installed under the wheelchair cushion that connects via Bluetooth to a mobile app. The mobile app displays information about weight shifts, goal-setting functions, and feedback on performance/outcomes.
15741016|NCT04934137|Behavioral|AW-Shift|The AW-Shift system uses a pressure-sensing mat installed on top of the wheelchair cushion that connects via Bluetooth to a mobile app. The mobile app displays visual representation of the seating surface and can set reminders for weight shifts.
15741017|NCT04934124|Drug|ITI-333|ITI-333 oral solution
15741018|NCT04934124|Other|Placebo|Matching placebo
15741019|NCT04934111|Drug|LNP-nCOV saRNA-02 Vaccine|a self-amplifying ribonucleic acid (saRNA) vaccine encoding the S glycoprotein of SARS-CoV-2, the causative agent of COVID-19
15741020|NCT04934098|Device|Adjustable Compression Wrap|The material will be delivered, adapted, and oriented for the daily use of the adjustable compression wrap (Ready Wrap®). The wrap allows for easy use because it is the pre-molded system in inelastic material with self-adjusting compressible components according to the size and shape of the upper limb. Due to its compression properties, it can be used as a therapy to control lymphedema. The material composition is: 61% Nylon, 33% Polyurethane, 6% Elastane (Spandex)). The institutional protocol for the control of the lymphedema phase will be respected, in which the orthosis is used at home for the longest period possible, with the only removal for bathing and sleeping; in addition, skincare and therapeutic exercises for the upper limbs should be performed daily.
15741021|NCT04934098|Device|Compression Bandage|Evaluation, skincare, compression bandaging, and guidance on therapeutic exercises for upper limbs. The material used for binding is tubular mesh, foam, elastic compression bandage. Therapy will be followed according to the institutional protocol for the lymphedema reduction phase, in which it will be reassessed twice a week for 30 days.
15741024|NCT04934059|Drug|Yuxuebi tablet|0.5g/ tablet
15741025|NCT04934059|Drug|Placebo tablet|0.5g/ tablet
15741026|NCT04934046|Other|Additional acquisition|Additional SPECT acquisition (30min added time approximately), with no added radiation
15741027|NCT04934033|Other|Neurological assessments|The participants will have a MRI, and language and cognitive assessments.
15741028|NCT04934020|Other|Pre-pandemic stroke related metrics|De-identified data from selected stroke metrics identified by ICD-10 codes will be abstracted from medical records of stroke patients in about 200 stroke centers in 6 continents.
15741029|NCT04934020|Other|Stroke related metrics during the pandemic|De-identified data from selected stroke metrics identified by ICD-10 codes will be abstracted from medical records of stroke patients in about 200 stroke centers in 6 continents.
15741030|NCT04934007|Device|rTMS Treatment|1 Hz rTMS
15741031|NCT04933994|Device|computed Tomography|All cases were detected with computed Tomography
15741032|NCT04933981|Diagnostic Test|Nasopharyngeal swab for SARS-CoV-2|in the interventional group, regular, i.e. twice to three times weekly, SARS-CoV-2 testing was offered to health-care workers and visitors of nursing homes
15741033|NCT04933968|Biological|ALVR106|Infusion, visually identical to placebo
15741034|NCT04933968|Biological|Placebo|Infusion, visually identical to ALVR106
15741035|NCT04933955|Procedure|vital pulp therapy|pulpotomy
15741036|NCT04933942|Drug|Lomustine|Oral administration of Lomustine
15741037|NCT04933942|Drug|Romiplostim|Subcutaneous administration of Romiplostim
15741038|NCT04933929|Behavioral|Post-hospitalization nutritional monitoring|Post-hospitalization nutritional monitoring, carried out by dieticians from Saveurs & Vie. Consultations are done remotely, by phone only. Dietitians have gained experience in home nutritional monitoring of elderly people over the phone during the first wave of Coronavirus disease 2019 (COVID-19) .
15741039|NCT04933916|Drug|EMB-001|Combination product metyrapone and oxazepam
15741040|NCT04933903|Drug|Ipilimumab|1mg/kg IV on day 1 (1 dose total)
15741041|NCT04933903|Drug|Nivolumab|3mg/kg (to a maximum of 240mg) IV on days 1, 15, 29 (+/- 3 days) (3 doses total)
15741042|NCT04933903|Radiation|SBRT|1 fraction or 2 fractions delivered to the gross primary tumor and nodal disease, following the first treatment with ipilimumab + nivolumab on days 1-3.
15741043|NCT04933890|Device|Use of Eko DUO electronic stethoscope|Auscultation of heart sounds using electronic stethoscope
15741044|NCT04933877|Procedure|Fascial plane block|Serratus anterior plane block
15741081|NCT04933604|Procedure|laparoscopic partial nephrectomy|Nephron sparing minimally invasive surgery
15741082|NCT04933604|Procedure|Laparoscopic radical nephrectomy|Completely removal of kidney by using laparoscopic surgery
15741083|NCT04933591|Drug|Diosmin / Hesperidin|Venoactive drugs are used for patients with varicose veins as a tool for alleviating symptoms
15741882|NCT04926844|Drug|Placebo|Intravenous isotonic saline (1.2 ml/kg) over 5 minutes
15741045|NCT04933864|Drug|Methylene Blue and Photodynamic Therapy|"Treatment group. Methylene blue (SamaraMedProm, Russia, Registration number: MP-001834, 13.09.2012) 1 mg/kg concentration orally one time were added to the current therapy of the participant (e.g., azithromycin, hydroxychloroquine, aminodihydrophthalazinedione sodium, levofloxacin, etc.), if any, and irradiation of the participant's chest was performed by 650 nm laser source (UFPh-675-01-BIOSPEC, BIOSPEC, Russia, Registration number: 2009/04648, 26.03.2009) with 18 J/cm^2 energy dose.
~For critically ill participants: Inhalation by 0.2 mg methylene blue (SamaraMedProm, Russia, Registration number: MP-001834, 13.09.2012) 10 ml water solution and irradiation of pharynx and nasal cavity by 650 nm laser source (UFPh-675-01-BIOSPEC, BIOSPEC, Russia, Registration number: 2009/04648, 26.03.2009) with 36 J/cm^2 energy dose were performed."
15741046|NCT04933851|Behavioral|ACT1VATE|ACT1VATE, informed by Acceptance and Commitment Therapy (ACT), will consist of five, 90-minute group-based telemedicine therapy sessions delivered by a Behavioral Health Provider.
15741047|NCT04933851|Behavioral|DSME/S|Diabetes self-management education and support (DSME/S) will be delivered by a Certified Diabetes Care and Education Specialist via one-on-one telemedicine format.
15741048|NCT04933838|Device|atelocollagen|"This collagen-contained product is used to supplement tendon, ligament, muscle, and (biological) membrane that is missing or damaged during internal/surgical treatment and surgery.
~Patients with chronic low back pain are randomized after obtaining informed consent for the study.
~Participants are divided into group A (atelocollagen) and group B (control). A physical examination for lumbar pain was performed and evaluated trigger points in multifidus, erector spinae, and quadratus lumborum muscles.
~After physical exam, cross sectional area of each muscle is measured by ultrasound in both gorup.
~Group A will receive atelocollagen mixture (atelocollagen 3 mL + 1% lidocaine 3 mL) and group B will receive local anesthetics only (Normal saline 3 mL + 1% lidocaine 3 mL).
~Each participants will be injected 1 mL of injectate into each muscle on both sides (total 6 mL)."
15741049|NCT04933825|Biological|ET-02|A conditioning therapy with cyclophosphamide and fludarabine will be conducted before ET-02 injection.
15741050|NCT04933812|Behavioral|Facebook discussions and Virtual group meetings|Participants must join a study-specific private Facebook group and engage in discussion. Once the discussion is complete, participants have the opportunity to join virtual group sessions via Zoom
15741051|NCT04933799|Drug|PF-06650833|"PF-06650833 is an investigational, highly potent and selective, reversible inhibitor of IRAK4. IRAK4 is a serine, threonine kinase that is a key intracellular signaling node downstream of the myddosome-associated Toll-Like Receptors (TLR) 1, 2, 4, 5, 6, 7, 8, 9 and 10, and the interleukin (IL)-1 family receptors (IL-1R, IL-18R and IL-33R) that mediate much of the innate immune signaling.
~As an inhibitor of TLR signaling, PF-06650833 targets a different part of the immune system from the Janus kinase (JAK) inhibitors. Given the partial redundancy of innate immune signaling through IRAK4-independent TLR pathways and the lack of direct suppression of T- and B-cell signaling, PF-06650833 is unlikely to lead to exaggerated immunosuppression."
15741052|NCT04933799|Drug|Matching Placebo|Placebo will match the study drug in dose, formulation, route and frequency.
15741053|NCT04933786|Behavioral|Digital Health Nudging|Short daily text messages with information and motivation concerning physical activity.
15741054|NCT04933773|Other|Movement artifact - knocking|60 seconds motion artifact simulation - knocking with sensors
15741055|NCT04933773|Other|Movement artifact - tremor|60 seconds motion artifact simulation - tremor with sensors
15741056|NCT04933773|Other|Artifact - ambient light|60 seconds artifact simulation - ambient light using sensor opening
15741057|NCT04933773|Other|Artifact - low perfusion|60 seconds artifact simulation - reduced perfusion using a cuff
15741058|NCT04933773|Other|SpO2 measurement|Two SpO2 measuring devices are active simultaneously on one hand during measurement.
15741059|NCT04933760|Diagnostic Test|Cytovale IntellipSep test|The Cytovale IntelliSep test measures a series of physical properties that indicate activation of leukocytes obtained from a venous K2-EDTA anti-coagulated whole blood sample.
15741062|NCT04933721|Drug|berotralstat|BCX7353 capsules administered orally once daily
15741063|NCT04933708|Behavioral|Labor Podcast|"Listening to podcasts.
~Topics include:
~Labor Anesthesia, Induction of Labor, Second Stage of Labor, Reasons for Cesarean Section, Postpartum Recovery, Complications of Labor and Birth"
15741064|NCT04933695|Drug|Sotorasib|Oral tablet
15741065|NCT04933682|Drug|ALXN2050|Oral tablet.
15741066|NCT04933682|Drug|Fluconazole|Oral tablet.
15741067|NCT04933682|Drug|Rifampin|Oral capsule.
15741068|NCT04933669|Drug|Imatinib|Imatinib neoadjuvant therapy
15741069|NCT04933656|Dietary Supplement|one 24 hr cycle of meals at a 2000 kcal level|50g added sugar
15741070|NCT04933656|Dietary Supplement|one 24 hr cycle of meals at a 2000 kcal level + one serving sugar sweetened beverage|90 grams added sugar
15741071|NCT04933656|Dietary Supplement|one 24 hr cycle of meals at a 2000 kcal level + two servings sugar sweetened beverage|130 grams added sugar
15741072|NCT04933656|Dietary Supplement|one 24 hr cycle of meals at a 2000 kcal level + three serving sugar sweetened beverage|170 grams added sugar
15741073|NCT04933630|Drug|FDA-approved selective-serotonin reuptake inhibitors (SSRIs) and selective-norepinephrine reuptake inhibitors (SNRIs)|Participants exiting the TRAIT study will have received a 90-day supply of their current protocol-approved antidepressant treatment (ADT) if clinically appropriate, prior to entering the TRAIT-RS study, in addition to a continuity of care letter to be given to their medical provider to facilitate a refill of that medication as desired. (See NCT04748276 for specific formulary and prescribing guidelines).
15741084|NCT04933578|Behavioral|Dental anxiety scales|"The Faces Version of Modified Child Dental Anxiety Scale (MCDASf), which is a psychometric dental anxiety scale for children with eight questions, was used to determine the dental anxiety levels of the children. The scores of each question are represented by varying cartoon faces according to emotions ranging from 1 'relaxed' to 5 'very anxious'. The total scores range from 8 to 40. The scores were categorized as not anxious (>9), slightly anxious (9-16), fairly anxious (17-24), very anxious (25-32), and extremely anxious (33-40).
~the Modified Dental Anxiety Scale (MDAS) was administered to parents, differently from children. The MDAS has five questions. The scores of each question range from 1 'relaxed' to 5 'very anxious.' The total score ranges from 5 to 25."
15741085|NCT04933565|Drug|ORG-129|ORG-129 oral capsules
15741086|NCT04933565|Drug|Placebo|Placebo oral capsules
15741091|NCT04933526|Drug|Flumatinib|Flumatinib 600mg QD orally form 1 to 12 months
15741092|NCT04933526|Drug|Dasatinib|Dasatinib 100mg QD orally form 1 to 12 months
15741093|NCT04933513|Behavioral|pre DBS patients responding to the DBS-PS scale|we propose to parkinson's disease patients selected for subthalamic deep brain stimulation to complete the DBS-PS scale preoperatively
15741094|NCT04933500|Device|Whitacre spinal needle|25G Whitacre spinal needle
15741095|NCT04933487|Device|IOL implantation experimental|Monolateral implantation of toric intraocular lenses Ankoris. (Manufactured by PhysIOL sa/nv, Liège, Belgium).
15741096|NCT04933474|Behavioral|painTRAINER®|PainTRAINER is among the most widely validated mHealth interventions for pain management.18-25 Originally developed by members of our team at Duke and Northwestern University under NIH funding, the app teaches evidence-based pain coping skills using a self-administered, home-based software program. The system delivers eight sessions via any web-connected platform, including Android or iOS smartphones, tablets, or personal computers. The digital curriculum covers progressive muscle relaxation, activity/rest cycling, pleasant activity scheduling, recognizing negative automatic thoughts, pleasant imagery/distraction, problem solving, and monitoring for maintenance. Patients complete one session per week in a pre-determined order. The program can be completed in a flexible manner to accommodate life and medical events.
15741097|NCT04933474|Device|PICO G2 4k|Prior research has shown that daily use of VR for 10 to 15 minutes is effective in managing pain, plus use as needed for breakthrough flares of pain. The skills-based VR therapy program, EaseVRx, is a standardized 56-day program consisting of scheduled daily virtual experiences. Each VR treatment experience lasts between 2-16 minutes, with an average duration of 6 minutes. To minimize the risk of cybersickness, participants are instructed to complete one VR treatment experience at a time. Given the low-risk nature of VR, they also may repeat experiences such as relaxation, breathing exercises, and games at other times during the day, in response to their pain. After the 56-day program is completed, participants in this arm are instructed to continue daily use, choosing from among the treatment experiences.
15741098|NCT04933461|Device|Safety lancet|There are sterile, single-use safety lancets designed for the sampling of capillary blood from the fingertip of patients.
15741099|NCT04933448|Other|Ketogenic Diet|The ketogenic diet (KD) is an alternative feeding regimen that has been in use since 1921. It is a high-fat, low carbohydrate, and moderate protein diet. There are various forms of the KD. The classic KD consists of long-chain triglycerides with a fat-to-combined-protein-and-carbohydrate ratio that can vary. At the investigating institution, it is standard of care to initiate a ketogenic diet at a ratio of 2:1, and to increase the ratio to 3:1 or 4:1 as needed to achieve ketosis.
15741100|NCT04933435|Other|Quality of life questionnaires|European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (QLQ-C30) and Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep)
15741101|NCT04933422|Drug|CM93|oral capsule of CM93 administered once daily
15741102|NCT04933409|Procedure|3D printed replica of the donor tooth|3D printed replica of the donor tooth.
15741103|NCT04933409|Procedure|Conventional Autotransplantation of tooth|Conventional Autotransplantation of tooth without using the 3D printed guide
15741104|NCT04933396|Diagnostic Test|ultrasound diagnostic criteria|evaluate using the recent consensus based definition for FGR using biometric and Doppler parameters to identify fetuses at risk of adverse perinatal outcomes compared to using solely biometric based parameter (EFW <10th percentile according to the Hadlock growth standard).
15741105|NCT04933383|Drug|AQ001S 0.125 mg/ml|administered by nebulization once daily
15741106|NCT04933383|Drug|Budesonide 0.125 mg/ml inhalation suspension|administered by nebulization once daily
15741107|NCT04933370|Other|Stimulation parameters|Different device stimulation parameters
15741108|NCT04933357|Radiation|Dose escalation|Dose escalation to poor responders to achieve dose equivalent more than 80 Gy using SBRT boost
15741109|NCT04933357|Radiation|Standard dose|Standard dose to good responders to achieve dose equivalent of 70 Gy.
15741110|NCT04933344|Other|patients having had BJI or PJI treated with daptomycin|patients having had BJI or PJI treated with daptomycin who developped an adverse event : eosinophilic pneumonia and/or elevation of CPK
15741111|NCT04933331|Drug|Curodont Repair Fluoride Plus|Self-assembling peptide that integrates calcium and phosphate ions into the same hydroxyapatite that the enamel is made of through biomimetic re-mineralization. Amino acid sequence: CH3,COQQRFEWEFEQQ,NH2.
15741112|NCT04933331|Device|Silver Diamine Fluoride|Silver diamine fluoride 38% is indicated for the treatment of dentinal hypersensitivity. SDF works by killing pathogenic organisms and hardens softened dentin making it more acid and abrasion resistant. The ADA recommends the use of SDF in treating early lesions.
15741196|NCT04932577|Biological|Faecal microbiota trnasplantation|All participant will receive three applications of either FMT or placebo and afterwards followed for 1 year.
15741197|NCT04932577|Biological|Placebo|Placebo
15741113|NCT04933331|Device|Glass Ionomer Sealant|A hydrophilic type of sealant material made with water, polymeric acid, and glass power. These sealants release fluoride over time which also helps protect against and repair initial caries lesions. The ADA recommends the use of sealants in treating occlusal early lesions.
15741114|NCT04933331|Device|Fluoride varnish|2.5% Sodium Fluoride Varnish which reduces dentinal hypersensitivity by occluding dentinal tubules.
15741115|NCT04933331|Drug|Fluoride toothpaste|Prescription sodium fluoride toothpaste medicament used in place of regular toothpaste. It works by making the teeth stronger and more resistant to caries.
15741116|NCT04933318|Other|TENS|Transcutaneus electrical nerve stimulation (TENS)- analgesic current therapy
15741117|NCT04933318|Other|shamTENS|shamTranscutaneus electrical nerve stimulation (shamTENS)- analgesic current therapy
15741118|NCT04933318|Other|IFC|Interferential current therapy (IFC)- analgesic current therapy
15741119|NCT04933318|Other|shamIFC|shamInterferential current therapy (shamIFC)- analgesic current therapy
15741120|NCT04933305|Procedure|Roux-en-Y Gastric Bypass|Laparoscopic surgical procedure
15741121|NCT04933292|Drug|Methylprednisolone and Mycophenolate mofetil|Methylprednisolone combination of mycophenolate mofetil
15741122|NCT04933292|Drug|Methylprednisolone and azathioprine|Methylprednisolone combination of azathioprine
15741123|NCT04933279|Dietary Supplement|iodine-containg spareribs soup|administrated a 150 ml - 200 ml of iodine-containg spareribs soup delivering ≈ 600 µg or 1200 µg iodine
15741124|NCT04933279|Dietary Supplement|intrinsic iodine in natural kelp|administrated 45 g or 80 g natural kelp delivering ≈ 600 µg or 1200 µg iodine (intrinsic iodine). The natural kelp will be approximately produced in an experimental barn feeding supplementary iodine to reach a final iodine intake of ≈ 600 µg or 1200 µg. The iodine intake of natural kelp will be adjusted to the required dose by determing iodine content in the natural kelp.
15741125|NCT04933266|Procedure|Subpectoral plexus block (low dose)|It is one type of peripheral nerve blocks for surgery over the chest. Patients will have an ultrasound scan and nerve block with local anesthetic (LA) agent (0.25% levobupivacaine 10ml) injected 2 target sites through one skin puncture. One at the myofascial plane between the pectoralis major and minor (5ml of LA) and then under direct ultrasound visualization, the needle will be redirected and the remaining 5ml of LA will be injected at the plane between the pectoralis minor and the serratus anterior muscle, close to the origin of thoracoacromial artery from the axillary artery at the level of the third rib.
15741126|NCT04933266|Procedure|Subpectoral plexus block (High dose)|It is one type of peripheral nerve blocks for surgery over the chest. Patients will have an ultrasound scan and nerve block with local anesthetic (LA) agent (0.25% levobupivacaine 20ml) injected 2 target sites through one skin puncture. One at the myofascial plane between the pectoralis major and minor (10ml of LA) and then under direct ultrasound visualization, the needle will be redirected and the remaining 10ml of LA will be injected at the plane between the pectoralis minor and the serratus anterior muscle, close to the origin of thoracoacromial artery from the axillary artery at the level of the third rib.
15741127|NCT04933253|Procedure|Saline irrigation|Mediastinal irrigation with 2 L of 37 degree Celsius saline prior to chest closure
15741128|NCT04933240|Drug|Tamoxifen Citrate 10Mg Tab|nonsteroidal antiestrogen for oral administration in 10 mg tablets. Each tablet contains 15.2 mg of tamoxifen citrate which is equivalent to 10 mg of tamoxifen.
15741129|NCT04933240|Drug|Estradiol|estradiol tablets for oral administration contains 1 mg of micronized estradiol per tablet.
15741130|NCT04933240|Drug|Placebo|A sugar tablet that does not contain any active medicine
15741131|NCT04933227|Drug|Atezolizumab|Atezolizumab 1200 mg will be administered intravenously (IV) on Day 1 of each 21-day cycle.
15741132|NCT04933227|Drug|Tiragolumab|Tiragolumab 600 mg will be administered IV on Day 1 of each 21-day cycle.
15741133|NCT04933227|Drug|Oxaliplatin|Oxaliplatin 130 mg/m^2 will be administered IV on Day 1 of each 21-day cycle during Cycles 1-4.
15741134|NCT04933227|Drug|Capecitabine|Capecitabine 1000 mg/m^2/d will be administered orally (PO) twice daily (bid) on Days 1-14 during Cycles 1-4.
15741135|NCT04933201|Other|Music|Perioperative musical intervention
15741136|NCT04933201|Other|Routine perioperative treatment|Routine perioperative treatment
15741137|NCT04933188|Diagnostic Test|Myocardial work was estimated from left ventricular pressure-strain loop derived from speckle tracking echocardiography and non-invasive brachial artery cuff pressure|Baseline and follow-up examination of echocardiography is to be performed on study subjects.
15741138|NCT04933175|Drug|Fluzoparil|Fluzoparil: 150 mg, P.O, BID, d1-14, Q3W; Treatment until disease progression or intolerable side effects occur.
15741139|NCT04933175|Drug|Anlotinib|Anlotinib: 8mg, P.O, qd, d1-14, Q3W; Treatment until disease progression or intolerable side effects occur.
15741140|NCT04933162|Dietary Supplement|High Protein and Low Fiber Diet|Protein intake will be increased to be >40% calories from protein, and the fiber intake will remain <15gm/day.
15741141|NCT04933162|Dietary Supplement|Low Protein and High Fiber Diet|Increase fiber intake up to 40gms of fiber with a requirement to increase at least 15gms above baseline fiber, with 50-75% of total fiber intake from psyllium husk. Subjects will be allowed to slowly increase fiber every two days to reach goal by end of week 1. The total protein will be reduced to <10% total calories from protein.
15741142|NCT04933149|Drug|Ketamine Infustion|Intravenous infusion at 0.5 mg/kg/hr from induction to emergence from anesthesia during the subject's brachial plexus reconstruction surgery. In addition, subjects will receive postoperative ketamine infusion of 0.1-0.3 mg/kg/hr for 24 hours titrated to side effects while patients are admitted to the hospital following surgery.
15741143|NCT04933136|Device|Terry2 Band|Hemostasis protocol following radial or cubital approach catheterization using the dual artery hemostasis device Terry2Band.
15741144|NCT04933123|Device|indirect restorative treatement with a glass ceramic|Inlays and onlays of glass ceramic for molars and premolars are adhesively luted.
15741145|NCT04933097|Device|Microfet2®|"Conducting a day hospitalization including analyses:
~Quantitative muscular analysis by measuring the DEXA of the whole body, the reference method for measuring body compartments and allowing the diagnosis of sarcopenia (IMMA<7 in men and 5.5 in women)
~Qualitative muscular analysis:
~isokinetic measurement of muscular strength carried out on 3 muscle groups using a manual measurement sensor such as Microfet2 ® : quadriceps, triceps brachii, biceps
~measurement of grip strength using Jamar® equipment validated as recommended by the EWGSOP
~a walking test to assess the functional impact of sarcopenia and its severity"
15741146|NCT04933084|Behavioral|Pre-operative Opioid Education|"The pre-operative education in the text handout and pre-recorded video will include the topics of:
~Description of expected postoperative pain after robotic prostatectomy and typical opioid consumption after RARP.
~Efficacy of non-opioid multimodal analgesia and recommendation to take nonopioid alternatives prior to prescribed opioids.
~Adverse short- and long-term effects of opioids including nausea, vomiting, sedation, hypoventilation, hypotension, dizziness, constipation, depression, and addiction."
15741147|NCT04933071|Behavioral|Podcast|A list of podcasts that are specified for each rotation
15741148|NCT04933058|Drug|IV acetaminophen|Pain management
15741149|NCT04933058|Drug|IV fentanyl|Pain management
15741150|NCT04933045|Device|Arthrex InternalBrace|Placement of Arthrex InternalBrace for anatomic distal tibiofibular ligament augmentation to stabilize the ankle syndesmosis during surgery.
15741151|NCT04933019|Genetic|Detection of Clinclidamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR|Detection of Clindamycin Resistance Antibiotic Genes among Staphylococcus Isolates by Using Real Time PCR
15741152|NCT04933006|Diagnostic Test|Pulsevelocity|arterial stiffness evaluation with pulsewave velocity
15741153|NCT04932993|Behavioral|Writing down goals|Patient will write their health goals down before the visit.
15741154|NCT04932980|Drug|Aflibercept|administration of anti-VEGF Aflibercept (Eylea)
15741155|NCT04932980|Drug|Brolucizumab|administration of anti-VEGF Brolucizumab (Beovu)
15741156|NCT04932980|Procedure|early treat and extend (T&E)|extension of treatment intervals (T&E) from the beginning of treatment
15741157|NCT04932941|Drug|MP1032|Hard gelatin capsules for oral administration.
15741158|NCT04932941|Drug|Placebo|Placebo capsules matched to MP1032 for oral administration.
15741159|NCT04932928|Device|FreeStyle Libre|Flash glucose monitoring + Education on lifestyle modification
15741160|NCT04932928|Device|Blood glucose meter|Self monitoring of blood glucose + Education on lifestyle modification
15741163|NCT04932889|Other|Survey|A detailed anamnesis was retrospectively recorded about age, gender, body mass index, education, working, the presence of any chronic disease (diabetes mellitus, hypertension, chronic obstructive pulmonary disease, cardiac disease, cancer, rheumatological disease…), smoking, duration of symptoms, usage of supplementing vitamins such as vitamin D,C, zinc…, treatment place (home quarantine, hospital, intensive care unit), duration of home quarantine and hospital treatment, the number of months since the onset of Covid-19 symptoms, usage of anticoagulants, treatment drugs such as hydroxychloroquine, favipiravir. Also the symptoms during the period of Covid-19 infection were recorded from patient files; cough, fever, dyspnea, chest pain, loss of smell and taste, sore throat, headache, no symptom, musculoskeletal symptoms such as: muscle, low back, back, joint pain.
15741164|NCT04932889|Other|Laboratory parameters|The laboratory values of 182 patients, presence of chest computed tomography findings of 206 patients and symptoms of all patients during the period of Covid-19 infection, were retrospectively recorded. Laboratory values of hemoglobin, leucocyte, lymphocyte, platelet, C-reactive protein, erythrocyte sedimentation rate, ferritin, d-dimer, were recorded.
15741165|NCT04932889|Other|chest computed tomography|Typical findings of chest CT were; bilateral, multifocal, peripheral ground glass opacities with/without consolidation, including the fissures, close to visceral pleural surfaces. Covid-19 Reporting and Data System (CO-RADS) was used for chest CT. CO-RADS assigns scores from 1 (very low suspicion of Covid-19) to 5 (very high suspicion of Covid-19).
15741166|NCT04932876|Biological|SARS - COV 2 VACCINE|Vaccination for SARS - COV 2
15741167|NCT04932863|Biological|BNT162b2 mRNA Covid-19 Vaccine|Two injections, 21 days apart, of the BNT162b2 vaccine 30 μg per dose in the deltoid muscle.
15741168|NCT04932850|Biological|MAD0004J08|Human mAb 100 mg / 2.5 mL solution for injection
15741169|NCT04932850|Other|Placebo|Placebo matching to MAD0004J08 2.5 mL solution for injection
15741170|NCT04932837|Biological|Blood and Saliva collection|Serological, viral RNA and antigenic test
15741171|NCT04932824|Biological|SCB-2019|a Recombinant SARS-CoV-2 Trimeric S-Protein Subunit Vaccine for COVID-19.
15741172|NCT04932798|Diagnostic Test|Resting ECG (if first visit is done on site only)|"The standard 12-lead electrocardiogram is a representation of the heart's electrical activity recorded from electrodes on the body surface.
~This test requires around 15 minutes of the participant's time."
15741173|NCT04932798|Diagnostic Test|24-hour ambulatory electrocardiographic monitoring (Holter) (if first visit done on site only)|The Holter monitor is a type of portable electrocardiogram (ECG) worn continuously for 24 hours.
15741174|NCT04932798|Diagnostic Test|3-month AF detection monitoring using the Apple Watch|Patients with irregular heart rates will be notified by the Apple Watch and instructed to confirm the rhythm by using the integrated ECG recording system. This simply requires touching the watch with a finger from the opposite hand and provides a 30 seconds one-lead ECG recording of diagnostic quality. These tracing will be transferred to the study team for analysis using a dedicated email.
15741175|NCT04932785|Other|Regular diet|Regular diet
15741176|NCT04932785|Other|Clear Liquid Diet|Clear Liquid Diet
15741177|NCT04932772|Other|Kinesiotaping|Technique: Include Rectus Abdominas Muscles (RAM), Oblique Abdominal Muscles (OAM). Tape will be applied on RAM using muscles technique from origin to insertion of muscle with a tension between15-35%. Band will be start on symphysis pubis with no tension and then women make stretch on the abdominal region by deep abdominal inspiration and will end at xyphoid process. Finally will perform on the right and left external oblique muscles the procedure will be start with no tension from bottom and of 6-12 ribs and then the hip will be place in flexion and rotation to opposite direction and the band will tape on pubic bone with tension between 15-35% (Kase et al., 2003).
15741178|NCT04932772|Other|Abdominal Exercises|Women in group B will receive abdominal muscles exercise (2 sessions/ week) for eight weeks. This program will be applied in both group A and B. The women will repeat the same exercise program on other days as home routine. This program is proposed by Kamel and Yousif, 2017, as based on the literature (Kamel and Yousif, 2017), there is no golden standard exercise program for DRAM. Illustrations of the exercises will be provided, so that the women could repeat the same exercise program on other days as a home routine. All the exercises will be performed while the subject tied a scarf around her abdomen. The following proposed one included sit ups, reverse sit-ups, reverse trunk twists, and U-seat exercises (Fig. 5). Each exercise was repeated 20 times and was increased by four repetitions each week throughout the interventions. In addition, a respiratory rehabilitation maneuver to involve the abdominal muscles, especially the transverse abdominis will be performed.
15741179|NCT04932759|Behavioral|music listening|music listening during dental treatment
15741180|NCT04932746|Drug|Dexmedetomidine|"Infusion syringes are supplied with a concentration of 0.25 mcg / mL (dexmedetomidine or placebo) either 80 mcg / 20 mL, 200 mcg / 50 mL, or 400 mcg / 100 mL.
~It begins with infusion of 4 ml within 10 minutes and then continues infusion, depending on the child's weight, at 1.6 ml / kg / h.
~All injections will be prepared randomly by a doctor who did not participate in the study, and then placed in unmarked infusion pumps, given to an anesthesiologist (more than 10 years experience in pediatric anesthesia) without knowledge of the infusion content. The randomization process is carried out via sealed envelope technique.
~The injections in both groups will be stopped before the skin is closed. Both patients and anesthesiologists blinded the study drug (dexmedetomidine or placebo) by infusion of solution (dexmedetomidine or placebo). Depending on the size in ml, to ensure that there is no bias and blindness to the medical team about what the drug is."
15741181|NCT04932746|Drug|Placebo|The same anesthesia, the same amount of Saline solution will be administered, instead of dexmedetomidine, with the same protocol
15741182|NCT04932733|Other|Exercises|The participants in the experimental group underwent a single session of 5-minute quadriceps isometric exercise. The participant was asked to take rest 10 minutes before performed the exercise. After that, the exercise was performed from a long-sitting position.
15741183|NCT04932733|Other|Active exercise|The participants in the control group received a single session of 5-minute quadriceps active range of motion exercise. The participant was asked to take a rest of 10 minutes before participating in the exercise program. Then, the exercise was performed from a short-sitting position.
15741184|NCT04932720|Behavioral|chıld yoga programme|"Yoga sessions were in the form of 6 sessions and were held as 2 sessions per week. The program was given by an expert yoga instructor who has an international Yoga Alliance approved child and adolescent yoga certificate.Consisting of the components of Hatha Yoga (HY), one of the yoga types known and widely practiced all over the world; Sessions consisting of asanas (yoga postures), pranayamas (breathing techniques), relaxation, relaxation exercises and meditation were prepared. Sessions are 45 minutes; For those who are new to yoga for the first 15 minutes; mental and physical preparation; asanas, pranayamas were taught, drama followed by breathing exercises and asanas in the next 30 minutes, relaxation techniques (imaginary journey) and meditation in the last 15 minutes."
15741185|NCT04932707|Other|sub-occipital muscle inhibition technique|this technique will be conducted from a supine lying position. The therapist stretches the suboccipital, placing the hands beneath the patient head applying pressure up and backward, pressure was maintained till tissue relaxation was occurred flexes the head of the patient to get the chin to the manibiurim sternii, plus the passive stretch exercise
15741186|NCT04932707|Other|Neural slump sliding stretch|Patient in a comfortable short sitting position at the edge of the bed with the trunk in an military straight position then ask the patient to slump; flex her neck and street the knee joint in complete extension the at the end of the procedure do active dorsiflexion at the tested foot plus the passive stretch exercise
15741187|NCT04932707|Other|control (passive stretch exercises)|The patient in a comfortable supine lying position, the patient was asked to flex his hip joint with complete knee extension and ankle in neutral position. The therapist stretches the hamstring of the dominant side
15741188|NCT04932694|Other|Core stabilization training|Exercise training will be given to the participants in the study group in the form of core training exercises for 8 weeks.
15741189|NCT04932668|Other|Feasibility and Impact of Home-based Electrical Stimulation Program|"Home-based NMES program on spastic leg. The NMES pre-programmed dosage (locked):
~NMES waveform is biphasic PC, Frequency 50Hz, pulse width 400µs, ON:OFF 10s:20s and current amplitude: individual maximum tolerated to achieve ankle dorsiflexion."
15741190|NCT04932655|Drug|simufilam|Simufilam 100 mg oral tablets: the Phase 3 oral tablet for the first 3 arms and the Phase 2 tablet for the 4th arm.
15741191|NCT04932642|Behavioral|HIIT+RT experimental group|Each experimental group will be compared with their another contrast order session group
15741192|NCT04932642|Behavioral|RT+HIIT experimental group|Each experimental group will be compared with their another contrast order session group
15741193|NCT04932629|Biological|Ex-vivo cultivated Allogeneic limbal stromal stem cells|n this prospective intervention study patients with unilateral superficial corneal scars will undergo a surgical procedure and in the second procedure, the eligible patients will undergo corneal transplant surgery, when the central corneal epithelium will be removed using a surgical sponge. 0.1ml of stromal cells in a concentration of 0.5x10*6 cells/µl diluted in the thrombin component of fibrin glue (TISEEL, Baxter) will be applied to the debrided corneal stroma. A soft bandage contact lens will be placed over the cornea at the end of the procedure. The patient will receive topical antibiotic and steroid eye drops in the post-operative period. Periodic comprehensive ophthalmic evaluation along with anterior segment optical coherence tomography (ASOCT) scanning and slit-lamp photography will be done at Day 1, Day 7, Day 30, Day 90, Day 180 and Day 360 and 720 Days post-surgery
15741194|NCT04932603|Other|Standard of care, with intervention of the multidisciplinary team|Patients with AF, aged of 75 years or more, with evaluation of their antithrombotic treatment by the multidisciplinary team. The review of patient's file by the multidisciplinary team is based on physician decision. These patients are hospitalized in one of the 6 geriatrics units participating in the study and / or are hospitalized in another ward but their clinical file is reviewed by the multidisciplinary team.
15741195|NCT04932590|Other|End-expiratory occlusion test|The test consists in interrupting the ventilator at end-expiration for 15 seconds and assessing the resulting changes in cardiac output. Delays necessary to allow sufficient pulmonary transit time to allow good pulmonary venous return and therefore an increase in cardiac preload.
15741198|NCT04932564|Drug|Leflunomide tablet|"Leflunomide will be given at standard dose (100 mg OD x 3 days followed by 20 mg OD) in adults and weight based dose in children.
~The dosing for children will be as follows:
~<20 kg - 100 mg x 1 day followed by 10 mg every alternate day
~20-40 kg - 100 mg x 2 days, followed by 10 mg daily
~>40 kg - Usual adult dose.
~This is scheduled to be continued for 1 year from the time of attaining complete response of musculoskeletal GVHD."
15741199|NCT04932551|Other|Questionnaire|physicians will participate in the questionnaire via WeChat. The questionnaire included six main items: physician demographic characteristics, awareness, diagnosis, medical prescription, assessment/education, and proposal.
15741200|NCT04932538|Other|Kİnesio Taping|Kinesio Taping® (KT) is used for pediatric rehabilitation to reduce pain, facilitate or inhibit muscle activity, prevent injuries, reposition joints, aid the lymphatic system, support postural alignment, and improve proprioception
15741201|NCT04932525|Procedure|Biopsy|Blood and tumor samples for Genetic Profiling research
15741204|NCT04932499|Other|Standard of Care|Participants randomly assigned to this intervention will receive standard of care given to all patients undergoing total knee arthroplasty at our institution as outlined in the Common Care Pathway for Total Joint Replacement. Outcome assessments will be completed pre-operatively, each day while in hospital and 7 and 14 days postoperative.
15741205|NCT04932499|Other|Mindfulness Meditation|"In addition to standard of care, participants randomly assigned to the treatment group will be given a 45-60 minute teaching session on mindfulness meditation. Upon completion of this session, participants will be given homework recordings of a body scan exercise and asked to listen to the recording daily for the two-week period prior to surgery. Participants will be asked to listen to their recording immediately prior to their surgery and daily while in hospital. In addition, participants assigned to mindfulness intervention will receive standard of care as outlined in the control group. Outcome assessments will be completed pre-operatively, each day while in hospital and 7 and 14 days postoperative."
15741206|NCT04932486|Device|Transcutaneous electrical stimulation|Transcutaneous electrical stimulation of the upper airway muscles
15741207|NCT04932486|Device|Inactive transcutaneous electrical stimulation|Inactive transcutaneous electrical stimulation of the upper airway muscles
15741208|NCT04932460|Procedure|CEUS|CEUS is performed before neoadjuvant treatment and surgery to evaluate the status of axillary lymph node and locate the sentinel lymph node.
15741209|NCT04932460|Procedure|blue dye|Before operation, blue dye is injected for sentinel lymph node mapping.
15741211|NCT04932434|Drug|Psilocybin therapy|"Psilocybin administration session 1: 10mg delivered orally with psychological support and monitoring
~Psilocybin administration session 2: 25mg delivered orally with psychological support and monitoring"
15741212|NCT04932421|Behavioral|Emotion Detectives: Unified protocol for transdiagnostic treatment of emotional disorders in children (UP-C)|"UP-C is a transdiagnostic and emotion-focused cognitive-behavioral group intervention for children aged 6-12 years old with emotions disorders (i.e., anxious and/or mood disorders) and their parents. UP-C unifies cognitive-behavioral, contextual (eg. mindfulness) and parental training techniques aiming to reduce the intensity and frequency of children's clinical symptomatology.
~The intervention consists of 15 weekly group sessions (90 minutes per session; 5-8 children and parents per group) conducted by at least two clinical psychologists trained in the UP-C. The sessions start with the parents and children together (15 minutes); then, one psychologist conduct the session with the group of children while the other psychologist conduct the session with the group of parents, simultaneously (60 minutes); finally, the session ends with the group together (15 minutes). This is a structured and manualized intervention with a manual for the therapist and a workbook for the child and parents."
15741213|NCT04932421|Other|ABC of Emotions|"ABC of Emotions is a psychoeducational group intervention for children with anxiety and/or mood disorders, aged between 6 to 12 years. ABC of Emotions consists of 5 group psychoeducation sessions (about 90 minutes per session; 5-8 children per group). This is a structured and manualized intervention, with a manual for the therapist and a workbook for the child.
~The contents of the sessions were developed by the researchers of this study and are based on classic psychoeducational cognitive-behavioral therapies (CBT) strategies. Since anxiety disorders are more frequent in childhood than mood disorders (e.g., Merikangas et al., 2009), this program is essentially based on psychoeducation materials focused on emotions such as anxiety and fear. However, the same materials are available in an attachment, adapted for use with children to whom the main emotion is not fear/anxiety, but sadness (as in mood disorders)."
15741214|NCT04932408|Other|Evaluation of the feasibility, psychosocial effects, influence and perception of exercise selection an experimental design of exercises performed at the hip and chest region.|A single exposure feasibility study using elastic resistance bands in older adults to challenge stability. Exercises with an elastic resistance band anchored from the ground and placed at the hip and chest region will be trialled. A semi- structured interview will identify the impact and practicalities of the intervention. The information will be used in the development of an evaluation process with key consideration of the planning phase of the intervention. Questions with verbal cues to provide perceptions of the exercise selection such as likes/dislikes, safety, confidence, difficulty, enjoyment and band placement will be asked to determine the acceptability, accessibility, appropriateness and usability of the protocol and build insights into the participant preferences.
15741215|NCT04932395|Drug|Anshen Buxin Liuwei Pill|15 capsules/time, 2 times/day, orally.
15741216|NCT04932395|Drug|Placebo|Placebo simulated as the Anshen Buxin Liuwei Pills with same appearance，smell and taste,15 capsules/time, 2 times/day, orally.
15741217|NCT04932382|Drug|Misoprostol|will be used 3 h before IUD insertion
15741218|NCT04932382|Device|IUD|a copper T380A IUD
15741219|NCT04932369|Behavioral|Emotion Regulation training based on DBT|trained about emotion regulation and problem solving during eight 90-min group sessions
15741259|NCT04932044|Behavioral|Early Sleep Facilitation Program|It is divided into two stages. The first stage is to provide sleep circadian rhythm training for preterm infants during hospitalization, and the second stage is to give the caregiver the nursing guidance to promote preterm infants' sleep before preterm infants discharged from the hospital. Moreover, continue to give nursing guidance and follow its implementation status within two months after discharge.
15741220|NCT04932356|Other|Therapeutic education by phone|The patients who participate in the intervention group, after their face-to-face visit, will undergo a fortnightly reinforcement by telephone of diabetes education (review of diet, physical exercise, doubts about insulin or oral medication and the registry of blood glucose controls). In addition, emotional support will be provided to the patient, along with a semester calendar with scheduled calls to carry out the intervention, at a specific time.
15741221|NCT04932356|Other|Therapeutical education traditional|The patients participating in the study will be visited in person every six months where the control group will follow the usual protocol of the health center in the face-to-face visits, with their respective analyzes and pertinent tests, together with health education and adherence to pharmacological treatment.
15741222|NCT04932343|Diagnostic Test|cohort study|no intervention
15741223|NCT04932304|Device|Transcranial direct current stimulation (tDCS)|
15741224|NCT04932304|Device|Sham Transcranial direct current stimulation (tDCS)|Sham Transcranial direct current stimulation (tDCS)
15741225|NCT04932291|Drug|vafidemstat|1.2mg capsule
15741226|NCT04932291|Drug|Placebo|placebo capsule
15741227|NCT04932278|Procedure|Osteopathic manipulative treatment|Osteopathic manipulative treatment (OMT) is hands-on care provided by an osteopathic physician (D.O.). During osteopathic manipulative treatment, an osteopathic physician may move participants' muscles and joints using osteopathic techniques including stretching, gentle pressure and resistance, as well as thrust techniques that apply a quick, therapeutic force of brief duration that travels a short distance.
15741228|NCT04932278|Procedure|Usual care|Routine concussion managements with sports medicine physicians.
15741229|NCT04932265|Dietary Supplement|HRG80™ Red Ginseng|Capsules containing red ginseng preparation HRG80 capsules, 200 mg - reference product
15741230|NCT04932265|Combination Product|HRG80™ Red Ginseng + gamma cyclodextrin|Chewable tablets containing red ginseng preparation HRG80 (100 mg) incorporated in gamma-cyclodextrin (GCD) - experimental modified product
15741231|NCT04932252|Drug|A4368 or placebo tablet|orally administered
15741232|NCT04932239|Other|first aid education|To teach commercial motorcyclists first aid for post-crash while waiting for medical team to reach the scene
15741233|NCT04932226|Device|cloth mask|Buff bandana double layer worn over nose and mouth
15741234|NCT04932226|Device|surgical mask|standard surgical mask
15741235|NCT04932226|Device|FFP2 respirator|filtering facepiece 2 respirator
15741236|NCT04932213|Drug|Tropicamide Ophthalmic|Tropicamide eye drops are used for dilating pupils (mydriasis) to do comprehensive fundus examination.
15741237|NCT04932187|Drug|Capecitabine, Camrelizumab|This is a single-arm study with all patients receiving these two drugs.
15741238|NCT04932174|Other|High-intensity Interval Training|"Consisting of the following program:
~Warming up period for 10 minutes at 60-70% of HR max.
~Training phase 4x4 min intervals at 85-90% of HRmax with a 3 min active recovery at 70% of HRmax between each interval.
~Duration of HIIT 4 minute
~Number of interval per session 4
~Duration of rest interval 3 minute 3-10 min cool-down period, giving a total of 60 min."
15741239|NCT04932174|Other|Low-intensity Continuous Training|"Consisting of the following program:
~Warming up period for 10 minutes.
~Training phase for 60-minute walking on a treadmill at intensity 40-50% HRR (1- 6) weeks then 60-70% HRR (7-12) weeks.
~cooling down period for 10 minutes."
15741240|NCT04932161|Procedure|Titanium Granules|After degranulation of the intrabony defect, titanium particles will be placed in the defect and will be sutured.
15741241|NCT04932161|Procedure|Hydroxyapatite|After degranulation of the intrabony defect, hydroxyapatite will be placed in the defect and will be sutured.
15741242|NCT04932148|Other|Incremental HD|Starting haemodialysis at twice weekly frequency
15741243|NCT04932148|Other|Conventional HD|Starting haemodialysis at thrice weekly frequency
15741244|NCT04932135|Diagnostic Test|Continuous heart rate monitoring|Continuous heart rate monitoring with a wrist worn fitnesstracker
15741245|NCT04932122|Procedure|Dorsal wrist ganglion alone (DWG)|Patients assigned to this arm will undergo dorsal wrist ganglion cyst excision alone.
15741246|NCT04932122|Procedure|DWG/PIN|Patients assigned to this arm will undergo dorsal wrist ganglion excision and the addition of a partial wrist denervation by resecting the common terminal sensory branch of the posterior interosseus nerve (PIN)..
15741247|NCT04932109|Other|No intervention|No intervention in this group
15741248|NCT04932096|Dietary Supplement|melatonin|melatonin supplementation
15741249|NCT04932096|Behavioral|sleep management plan|Participants randomized to the intervention will receive an age-based sleep management plan created from American Academy of Pediatrics and American Academy of Sleep Medicine guidelines for healthy sleep in children.
15741250|NCT04932096|Dietary Supplement|placebo|cellulose filled capsule
15741251|NCT04932083|Drug|Bupivacaine|"patients will be put in the sitting position and lean forward. After sterilization, Dural puncture will be performed at L4-L5 interspace or L3-L4 with a 25 gauge Quincke spinal needle.
~patients will receive the local anesthetic dose of 0.5% heavy bupivacaine (12.5 mg) and 0.5 ml of sterile water will be added."
15741252|NCT04932083|Drug|Fentanyl|"patients will be put in the sitting position and lean forward. After sterilization, Dural puncture will be performed at L4-L5 interspace or L3-L4 with a 25 gauge Quincke spinal needle.
~patients will receive the local anesthetic dose of 0.5% heavy bupivacaine (12.5 mg) and 0.5 ml of fentanyl (25µg) will be added."
15741253|NCT04932083|Drug|Nalbuphine|"patients will be put in the sitting position and lean forward. After sterilization, Dural puncture will be performed at L4-L5 interspace or L3-L4 with a 25 gauge Quincke spinal needle.
~patients will receive the local anesthetic dose of 0.5% heavy bupivacaine (12.5 mg) and 0.8 mg nalbuphine hydrochloride in 0.5 ml sterile water will be added."
15741254|NCT04932083|Drug|Midazolam|"patients will be put in the sitting position and lean forward. After sterilization, Dural puncture will be performed at L4-L5 interspace or L3-L4 with a 25 gauge Quincke spinal needle.
~patients will receive the local anesthetic dose of 0.5% heavy bupivacaine (12.5 mg) and 0.4 ml of midazolam (2mg) + 0.1 ml of sterile water will be added."
15741255|NCT04932070|Dietary Supplement|Berberine|2 daily oral doses (one before lunch and one dinner) of 550 mg of berberine tablets
15741951|NCT04926181|Drug|Apalutamide|240 mg once daily, for a 28 day cycle
15741261|NCT04932018|Behavioral|Virtual Community of Support|The 6-month virtual community will consist of self-directed learning modules that will vary in content from worker and family relationships, collaboration and skill acquisition to self-care habits; problem-solving; monthly sessions will include a positive psychology exercise.
15741262|NCT04932018|Behavioral|Mentorship Incubator|The 6-month incubator intervention will consist of monthly interactive time with an assigned study facilitator/farmer mentor.
15741263|NCT04932005|Drug|DZD2269|Part A: A single oral dose at 5mg, 10mg, 20mg, 40mg, 80mg. Part B: A single oral dose at one selected dose level given in two treatment periods. Part C: Once or twice daily dosing for 7 days at two selected dose levels .
15741264|NCT04932005|Drug|placebo|Part A: A single oral dose. Part C: Once or twice daily dosing for 7 days.
15741265|NCT04931992|Other|No intervention|Retrospective analysis
15741266|NCT04931979|Drug|Pembrolizumab Injection [Keytruda]|Up to 17 cycles of pembrolizumab until disease progression, toxicity, death, or withdrawal of IC (whichever occurs first)
15741267|NCT04931979|Radiation|Salvage Radiation Therapy (SRT)|SRT according to standard of care (SRT with at least 66 Gy)
15741268|NCT04931966|Procedure|block|Adductor canal block
15741269|NCT04931966|Procedure|adductor canal block|adductor canal block bupivacain
15741270|NCT04931966|Procedure|Adductor Canal Block plus IPACK Block|Adductor Canal Block plus IPACK Block using bupivacaine
15741271|NCT04931966|Procedure|adductor Canal Block plus PAI Block|Adductor Canal Block plus PAI Block using bupivacaine
15741272|NCT04931953|Other|Intermittent theta burst stimulation (iTBS)|The localisation of the left dorsolateral prefrontal cortex (DLPFC) target will be identified using effective connectivity of the left caudate to identify the maximally-connected locus in the left DLFPC. Following this the iTBS will be administered to the target coordinates identified using the neuronavigation software available with the system. Connectivity-guided iTBS is then administered using a 70mm Double Air Film Coil (Magstim, Whitland, Dyfed, UK), connected to a Magstim Super Rapid-2 Plus-1 stimulator. The administration comprises bursts of 3 pulses at 50Hz with a power of 80% motor threshold at a burst frequency of 5 Hz (i.e., every 200ms) for 2 seconds, repeated every 10 seconds for a total of 190 seconds (600 pulses). Blocks are repeated a total of 3 times, with 5-minute rest intervals between blocks. During left DLPFC stimulation, the TBS coil is held by a support tangentially to the skull, with the axis of the coil angled approximately 90 degrees from the midsagittal axis.
15741273|NCT04931953|Other|Sham Intermittent theta burst stimulation (iTBS)|The sham iTBS administration is performed under the same conditions and with an identical protocol and equipment to the full administration, except that it uses a commercially available sham iTBS coil designed for use in double-blind trials. This sham coil looks like the real coil and connects to the iTBS unit but delivers only a very weak and shallow stimulation thus simulating the sounds made by the real iTBS coil.
15741274|NCT04931940|Dietary Supplement|Usual Care|Patients will receive the usual protein dosage at ≤1.2 g/kg/day for up to 28 days in the ICU
15741275|NCT04931940|Dietary Supplement|Higher Protein/Amino Acid Group|Patients will receive high protein dosage at ≥2.2 g/kg/day for up to 28 days in the ICU
15741276|NCT04931927|Behavioral|Making Connections Intervention-Telehealth (MCI-T)|Single session telehealth engagement intervention plus telehealth treatment as usual (TAU) [MCI-T +TAU]
15741277|NCT04931927|Behavioral|Treatment as usual (TAU)|Telehealth treatment as usual without the single session telehealth engagement intervention
15741278|NCT04931914|Other|Clinical pharmacy sharing in the patient care regimen|antibiotic regimens will be directed by a trained clinical pharmacist recommendation and supported by intensivist.
15741279|NCT04931901|Device|EMG TOF device|Use of Stimpod NMX450X as an electromyographic neuromuscular monitor
15741280|NCT04931888|Behavioral|EMPOWER|EMPOWER is an adapted social emotional learning (SEL) and wellness education initiative delivered to a community of refugee families that was developed through a pre-pilot in the New Haven Afghan refugee community in 2020. Unlike traditional school-based SEL curricula, EMPOWER partners with community organizations to provide translated and trauma-informed wellness education to family units. The program combines in-person (socially distant) and remote delivery of culturally-informed physical, emotional, and medical wellness tools adapted from evidenced-based behavioral medicine, refugee trauma and recovery, and community health research.
15741281|NCT04931875|Device|Total body PET/CT (uExplorer)|A total-body PET/CT scanner (uEXPLORER) with a 194-cm scan range will be applied in patients affected with lymphoma.
15741282|NCT04931862|Drug|WVE-004|WVE-004 is a stereopure antisense oligonucleotide (ASO)
15741283|NCT04931862|Drug|Placebo|Artificial cerebrospinal fluid (aCSF)
15741284|NCT04931849|Drug|Avatrombopag|Avatrombopag is a small molecule thrombopoeitic receptor agonist (TPO-RA) that mimics the biological effects of thrombopoeitin (TPO)
15741285|NCT04931836|Behavioral|Physical Activity Intervention|Three walking sessions/week for a total of 8 weeks (24 total sessions) - Walking sessions will either take place on new commercial treadmills in the Epidemiology Clinical Research Center or remotely at or around a participant's home. Regardless of the walking location, walking sessions will be 30 min in duration during intervention weeks 1 through 4 and a minimum of 45 min each during intervention weeks 5 through 8.
15741286|NCT04931823|Drug|CPO-100|Docetaxel albumin-bound
15741287|NCT04931810|Behavioral|All Nations Breath of Life|Same.
15741288|NCT04931797|Behavioral|video decision aid|advance care planning video decision aid
15741289|NCT04931797|Behavioral|control arm ACP information sheet|control arm ACP information sheet
15741290|NCT04931784|Drug|Nitrate|Administration of intra-coronary nitrate before percutaneous coronary intervention
15741291|NCT04931771|Device|vFFR guided revascularization|3D-angio-based vessel FFR (CAAS, Pie Medical Imaging, Maastricht, The Netherlands) uses 3-Dimensional Quantitative Coronary Angiography (3D-QCA) for functional assessment of coronary stenosis. vFFR is calculated using two angiographic views with at least 30 degrees difference in rotation/angulation to generate the 3D reconstruction of the coronary artery.
15741292|NCT04931771|Device|FFR guided revascularization|Fractional flow reserve (FFR) is a technique used in coronary catheterization to measure pressure differences across a coronary artery stenosis (narrowing, usually due to atherosclerosis) to determine the likelihood that the stenosis impedes oxygen delivery to the heart muscle (myocardial ischemia)
15741293|NCT04931758|Other|Pain Questionnaire|Subjects will take the FreBAQ questionnaire at Day 0 and a subgroup of 35 controls and 15 patients will take the same questionnaire at Day 7
15741297|NCT04931732|Biological|ctDNA analysis|ctDNA analysis of patients with suspected primary glioma tumors and in patients with suspected recurrence.
15741298|NCT04931719|Combination Product|PRP+Artz group|The patients in the PRP+Artz group received one intraarticular Artz injection (2.5 ml) followed consecutively by one intraarticular injection of PRP (3ml).
15741299|NCT04931719|Combination Product|PRP+ HYAJOINT Plus group|The patients in the PRP+HYAJOINT Plus group received one intraarticular HYAJOINT Plus injection (3ml) followed by one intraarticular injection of PRP (3ml).
15741300|NCT04931706|Other|Magnetics Assisted by Singe port|Use of magnet for assistance through the surgery, and a novel approach as it is single port
15741301|NCT04931693|Drug|paracetamol|iv post operative analgesia
15741302|NCT04931693|Procedure|modifiedPECs block|sonar guided pectoral nerve block
15741303|NCT04931680|Other|Data collection|During the follow-up consultation, six weeks after inclusion (S6), data will be collected using a standardized digital questionnaire, including clinical features, economic, social and cultural characteristics, housing conditions and therapeutic details (type of environmental decontamination and treatment received). Data will then be compared between patients with therapeutic success or failure. A urine test strip will also be used during the S6 consultation to screen for proteinuria. The prevalence of post-streptococcal glomerulonephritis will be extrapolated from that of proteinuria.
15741304|NCT04931667|Drug|Lorecivivint|Healthcare professional-administered intra-articular (IA) injection into one or both knees as clinically indicated. Bilateral injections of 0.07 mg of LOR are allowed. IA injection performed on Day 1. Additional IA injections of LOR to same knee (with at least a 6 month separation) between Day 1 and Month 33.
15741306|NCT04931641|Dietary Supplement|Galacto-oligosaccharides|Prebiotic galacto-oligosaccharides (GOS)
15741307|NCT04931641|Other|Maltodextrin|Maltodextrin (placebo)
15741308|NCT04931641|Dietary Supplement|Ferrous fumarate|50 mg iron as ferrous fumarate
15741309|NCT04931628|Drug|Salvianolic Acid|salvianolic acid, injection, 100mg+0.9%NaCl 250ml, qd, 14 days
15741310|NCT04931628|Drug|0.9% NaCl|0.9% NaCl
15741311|NCT04931615|Drug|ARTISS 4mL Fibrin Sealant Topical Solution (Frozen)|Wound seallant
15741312|NCT04931615|Other|no ARTISS|Wound closed without seallant
15741313|NCT04931602|Diagnostic Test|Biochemical markers i.e. Serum Ca, PTH, CTX, Albumin, Phosphate, Vitamin D and Bone mineral density Scan|investigations for secondary causes of osteoporosis
15741314|NCT04931576|Procedure|no drainage tube applied|No drainage tube implacement after TOETVA
15741317|NCT04931550|Device|Pacemaker implantation|Different pacing sites will be chosen according to the patients condition.
15741318|NCT04931524|Drug|carbon-14-[14C]-ANG-3777|Arms assigned to this intervention will receive 240 mg, IV and not more than 5.2 MBq, Fasted
15741319|NCT04931511|Drug|Compound betamethasone Injection(Gluteal muscle injection)|Gluteal muscle injection(Compound betamethasone 1ml + Sodium Chloride Injection 4ml) + Subacromial Ultrasound Guided injection(Sodium Chloride Injection 5ml)
15741320|NCT04931511|Drug|Compound betamethasone Injection(Subacromial Ultrasound Guided injection)|Gluteal muscle injection (Sodium Chloride Injection 5ml)+ Subacromial Ultrasound Guided injection (corticosteroid 1ml+Sodium Chloride Injection 4ml)
15741321|NCT04931511|Behavioral|Physical therapy|paticipant will be teached by the Physicaltherapist to reduce the shoulder pain at home
15741322|NCT04931498|Other|Questionnaire|Medical history, demographics and lifestyle factors will be assessed by the participant.
15741323|NCT04931498|Other|Anthropometric measurements: height, weight, and body fat|Height measured by stadiometer. Weight and body fat measured by Tanita scale bioelectrical impedance analysis.
15741324|NCT04931498|Other|Blood pressure and heart rate|Parameters will be measured using a validated, automated device while seated and again after 3-5 min standing. All measurements will be done in triplicate.
15741325|NCT04931498|Procedure|Venepuncture (GMPR)|"A blood sample of approximately 50 ml of venous blood will be taken. From the obtained blood sample, measurements will include a full blood count and the following phenotyping tests:
~Flow cytometry to quantify cell surface expression of key erythroid markers
~Proteomic analysis of isolated erythrocytes using mass spectrometry"
15741326|NCT04931498|Procedure|Venepuncture (SWAP70)|"A blood sample of approximately 50 ml of venous blood will be taken. From the obtained blood sample, measurements will include a full blood count and the following phenotyping tests:
~Flow cytometry to quantify cell surface expression of key markers
~Fluorescence-Activated Cell Sorting (FACS) to assess B-cell receptor signalling and to isolate cell type-specific RNA for transcriptome analysis
~Immunoglobulin isotype titre analysis in plasma
~Isolation of monocytes for subsequent use in phagocytosis assays"
15741327|NCT04931485|Other|Fluid management according to the REDUCE Fluid Protocol|Fluid management according to the protocol will be guided by pre-defined clinical signs for impaired perfusion and fluid overload.
15741328|NCT04931485|Other|Standard of care|Fluid resuscitation and de-resuscitation will be managed according to the standard of care
15741331|NCT04931446|Procedure|Biopsy/surgical tissue and peripheral blood|Retrieve specimens stored in the tissue bank, the main types of samples are RNAlater specimens, liquid nitrogen frozen specimens and peripheral blood specimens
15741332|NCT04931433|Drug|Lignocaine|Group A will receive 1.5mg/kg IV lignocaine bolus prior to induction followed by 2mg/kg/hour of lignocaine infusion throughout surgery until wound closure in which the infusion will be halved to 1mg/kg/hour until the end of surgery. The same rate will be infused in the recovery room for another half an hour before participant is discharge.
15741333|NCT04931433|Drug|Normal saline|Group B will receive saline of similar volume and rate as Group A
15741389|NCT04930991|Drug|Omeprazole|Treatment will consist of Omeprazole 2 weeks prior to surgical therapy of pancreatectomy.
15741334|NCT04931420|Drug|Standard of Care Chemotherapy|"If you have cancer of the stomach or food pipe (esophagus): the preferred chemotherapy regimen includes two or three medications. These drugs include Cisplatin or Oxaliplatin and 5-fluorouracil (5 FU) in combination with Docetaxel.
~If you have cancer of the pancreas or ampulla: the preferred chemotherapy medicines include Gemcitabine or a three-drug combination chemotherapy called FOLFIRINOX, which includes 5FU, Leucovorin, Irinotecan, and Oxaliplatin.
~If you have bile duct cancers: a combination of Gemcitabine, platinum agents, or fluoropyrimidine will be considered."
15741335|NCT04931420|Procedure|Video-Assisted Thoracic Surgery (VATS)|If you have lung cancer, you may receive video-assisted thoracic surgery (VATS): a type of minimally invasive thoracic surgery of the chest, performed with a thoracoscope (small videoscope) using small incisions and special instruments to minimize trauma.
15741336|NCT04931420|Procedure|Lobectomy|"If you have lung cancer, you may receive a lobectomy:
~A major/invasive surgical procedure where an entire lobe of your lung is removed."
15741337|NCT04931420|Radiation|Consolidative Radiation|A type of radiation treatment used to kill any cancer cells that may be left in the body. It may also include a stem cell transplant or treatment with drugs that kill cancer cells.
15741338|NCT04931420|Radiation|Ablation Treatment|"Depending on the location of you cancer and the state of your cancer after chemotherapy, you may receive on the the following ablation treatments:
~-Microwave or Radiofrequency Ablation: Radiofrequency ablation (RFA) and microwave ablation (MWA) are treatments that remove liver tumors by placing a needle through the skin into the tumor. In RFA, high-frequency electrical currents are passed through an electrode in the needle, creating a small region of heat. In MWA, microwaves are created from the needle to create a small region of heat. The heat destroys the liver cancer cells.
~-General Tumor Ablation Treatment: a minimally invasive surgical method to treat solid cancers. Special probes are used to burn or freeze cancers without the usual surgery. Doctors use images of your tumor to guide where they place the needle. This requires only a tiny hole, usually less than 3 mm via which the probe is introduced."
15741339|NCT04931420|Procedure|Resection or Excision|Depending on the type of GI cancer you have and the state of your cancer after chemotherapy, you may receive a resection or excision: a surgical procedure that focuses on removing all or part of a tumor/organ/body using a sharp knife (scalpel) or other cutting instrument.
15741340|NCT04931420|Procedure|Peritonectomy|Peritonectomy is a surgery used to remove peritoneal tumors (tumors in the lining of the abdomen/stomach) from a patient. Following surgery, a heated chemotherapy bath (HIPEC) is commonly administered.
15741341|NCT04931420|Other|Transarterial Radioembolization|"If you have cancer in your biliary tract (gallbladder, pancreas or liver), you may receive transarterial radioembolization known as TARE.
~TARE allows doctors to deliver radiation treatment directly to the liver using a minimally invasive technique that is designed to cause few side effects. TARE allows doctors to thread a catheter through a small incision in the participant's upper thigh through the artery that goes directly to the liver."
15741342|NCT04931407|Other|A 12-week interdisciplinary complex intervention|"The intervention will last for 12 weeks and includes four components; patient education, physical exercise, cognitive behavioral program and nutritional counseling.
~The patient education will include an online 2-hours group-based patient-education sessions in week 1.
~The physical exercise program includes two weekly exercise sessions, one supervised by a physiotherapist and one unsupervised, including aerobic exercise, resistance exercise and psychometric physiotherapy. Half of the intervention group (N=7) will perform the supervised exercise session individually with a physiotherapist in the municipality, while the other half (n=8) will exercise in online groups lead by physiotherapists.
~The cognitive behavioral program will begin in week 3 and include six group-based online sessions every week lead by a clinical psychologist.
~The nutritional counseling will include three individual digital nutrition counselling sessions in week 2, 6 and 10 by a clinical dietitian."
15741343|NCT04931394|Other|Adjuvant chemotherapy guided by organoid drug sensitivity test|Adjuvant chemotherapy guided by organoid will be given to pancreatic cancer patients.
15741344|NCT04931381|Other|Chemotherapy guided by organoid drug sensitivity test|Chemotherapy guided by organoid will be given to advanced pancreatic cancer patients.
15741345|NCT04931368|Drug|Experimental Treatment: one course Rituximab/HD-Methotrexate, two courses of MATRix|De-escalated induction treatment with R/HD-MTX and two courses of MATRix
15741346|NCT04931368|Drug|Control intervention: four courses of MATRix|Patients receive four courses of MATRix as induction treatment.
15741347|NCT04931355|Other|Acupuncture|The Acupuncture intervention（Zhongwan、Qihai、Guanyuan、Zhongji、Guilai、Shenshu、Ciliao、Xuehai、Sanyinjiao、Taixi.） will start on the 5th day of menstruation cycle, which will be carried out 1 time per day, at least 5 times a week, lasts for 10-15days. All operations were performed by experienced acupuncturists. After ET, both the control group and the treatment group will be treated with conventionally with no TCM intervention.
15741348|NCT04931355|Other|Western medicine|Western medicine
15741349|NCT04931342|Drug|Ipatasertib|Ipatasertib 400 mg will be administered by mouth once a day on Days 1-21 of each cycle. (Cycle length = 28 days)
15741350|NCT04931342|Drug|Cobimetinib|Cobimetinib will be administered by mouth at a dose of 60 mg once a day on Days 1-21 of each cycle. (Cycle length=28 days)
15741351|NCT04931342|Drug|Trastuzumab Emtansine|Trastuzumab Emtansine will be administered intravenously at a dose of 3.6 mg/kg on Day 1 of each cycle. (Cycle length=21 days)
15741352|NCT04931342|Drug|Atezolizumab|Atezolizumab will be administered intravenously at a dose of 1200 mg on Day 1 of each cycle. (Cycle length=21 days)
15741353|NCT04931342|Drug|Bevacizumab|Bevacizumab will be administered intravenously at a dose of 15 mg/kg on Day 1 of each cycle. (Cycle length=21 days)
15741354|NCT04931342|Drug|Paclitaxel|Paclitaxel will be administered intravenously at a dose of 80 mg/m2 on Days 1, 8, and 15 of each cycle. (Cycle length=28 days)
15741355|NCT04931316|Other|antiglaucoma|use antiglaucoma in ocular hypertension
15741356|NCT04931290|Procedure|Supracapsular Ahmed Glaucoma Valve plate delivery technique|incision of the perilimbal superior temporal conjunctiva with separation of the conjunctiva from the Tenon's capsule till reaching the encapsulated valve plate. Incision of the capsule in a z pattern will be done then the plate is dissected from the tissues and delivered out of the capsule through the opening to the subconjunctival space.The mobility of AGV and its tube will be evaluated and refixation of the plate will be done if needed. The plate will be covered with ologen implant sizing 12mm width and 1 mm thickness. The conjunctiva will be closed by 10/0 nylon sutures.
15741428|NCT04930653|Procedure|Extracorporeal Photopheresis|Undergo ECP
15741357|NCT04931277|Procedure|cataract surgery|stepped surgery in the form of primary phacoemulsification and secondary posterior chamber intraocular lens (PCIOL) implantation in patients with uveitis.
15741358|NCT04931264|Diagnostic Test|YuWell YE660D Electronic Sphygmomanometer|Measurement blood pressure by YuWell YE660D Electronic Sphygmomanometer and Desk Mercury Sphygmomanometer
15741361|NCT04931225|Drug|Landiolol|Intravenous Landiolol injection (from 0.5 to 10 µg/kg/min during 12 hours) up to a 15% decrease in HR on microcirculatory vascular reactivity.
15741362|NCT04931212|Procedure|FETO with Smart-TO balloon|Fetal endoscopic tracheal occlusion using the Smart-TO balloon Unplug procedure by peripheral course around the MR scanner
15741363|NCT04931199|Behavioral|Cognitive Behavioral Therapy (CBT)|The standard of care procedures for children with clinically elevated anxiety, depression, and PTSD is traditional CBT from their mental health provider.
15741364|NCT04931199|Behavioral|CBT+App|Participants receive CBT as usual enhanced with a simple, HIPAA compliant, web-based application to help mental health providers implement homework during CBT with children with elevated PTSD, anxiety, and/or depression, and their caregivers. The three major components of the app help providers to (1) Practice interactive, digitized CBT exercises with patients in-session; (2) Remind patients to practice CBT exercises for homework, and (3) Review homework during the next session.
15741365|NCT04931186|Other|retrospective analyis|retrospective analysis of data
15741366|NCT04931173|Other|IVA+OA versus IVA+MBP+OA|Non-inferiority RCT comparing IVA+OA+MBP vs IVA+OA to reduce surgical site infection following colon surgery
15741367|NCT04931160|Other|Blood, fluid, sells and urine samples|Blood, fluid, sells and urine samples will be collected.
15741368|NCT04931147|Drug|RXC007|RXC007 will be administered in the form of oral capsules at selected doses starting at 2 mg to 4 of the 6 participants within each cohort in Part A and Part B. For Part A, dosing frequency is one single dose on one occasion and for Part B, dosing frequency is single doses once daily for 14 days. If required, following dose escalation data review, dosing frequency and duration may be modified in Part B.
15741369|NCT04931147|Drug|RXC007 Matching Placebo|The matching placebo for RXC007 will be administered in the form of oral capsules matched to the number of active RXC007 capsules at each dose level to 2 of the 6 participants within each cohort in Part A and Part B. For Part A, dosing frequency is one placebo dose on one occasion and for Part B, dosing frequency is single placebo doses once daily for 14 days. If required, following dose escalation data review, dosing frequency and duration may be modified in Part B.
15741370|NCT04931134|Device|Trigeminal nerve stimulation - active|Active trigeminal nerve stimulation
15741371|NCT04931134|Device|Trigeminal nerve stimulation - sham|Sham trigeminal nerve stimulation
15741372|NCT04931121|Drug|Viscosupplements|Synovial fluid is collected as part of a conventional injection of viscosupplement
15741373|NCT04931108|Drug|Nitrendipine/Atenolol|Nitrendipine/Atenolol 5mg/10mg single-pill combination, oral tablet, one pill daily.
15741374|NCT04931108|Drug|Nitrendipine|Nitrendipine 5mg, oral tablet, one pill daily.
15741375|NCT04931108|Drug|Atenolol|Atenolol 25mg, oral tablet, one pill daily.
15741376|NCT04931095|Drug|Cannabis|Cannabis will be orally ingested via a brownie
15741377|NCT04931095|Drug|Alcohol|Alcohol will be orally ingested via a flavored drink
15741378|NCT04931082|Dietary Supplement|Probiotics|Capsule
15741379|NCT04931082|Dietary Supplement|Placebo|Capsule
15741380|NCT04931069|Other|Microbiota analysis|Microbiota analysis will be carried out on different samples: blood, stool and saliva samples will be collected during the surgery, between 5 and 10 days after surgery and at 3 and 6 months after the surgery. Bile, pancreatic and intestinal mucosa samples will only be collected during the surgery.
15741385|NCT04931030|Other|Dietary advice|Subjects are provided dietary advice by the dietitians as part of the research team/ investigators
15741386|NCT04931017|Drug|Extended Release Metformin Hydrochloride|Given PO
15741387|NCT04931004|Drug|Mouthwash Product|Commercially over-the-counter Colgate mouthwashes will be administered according to standard package instructions. Viral load will be measured prior to and after mouth rinse using serial face mask and saliva samples.
15741388|NCT04931004|Other|Water rinse|30-second water rinse will occur in the control group. Viral load will be measured prior to and after water rinse using serial face mask and saliva samples.
15741390|NCT04930965|Behavioral|Community health worker engagement|3-4 in-person or virtual engagements (individual or group sessions) over 1 month, each engagement lasting 30 minutes to 1 hour
15741391|NCT04930952|Drug|Ethanol-amine Oleate Sclerotherapy Injection|Intralesional Sclerotherapy Injection
15741392|NCT04930939|Other|Aerobic training cardiac rehabilitation program|Moderate continuous training sessions and high intensity interval training sessiones were used to carried out aerobic training
15741393|NCT04930913|Diagnostic Test|Three-dimensional Ultrasound|women suspected of having adhesions will perform 3D US
15741394|NCT04930900|Drug|ARS-1 with URTI|ARS-1
15741395|NCT04930900|Drug|ARS-1 without URTI|ARS-1 without URTI
15741396|NCT04930887|Drug|Exparel (Bupivacaine Liposome)|Non-opioid postsurgical analgesic used in the management of postsurgical pain; 133 mg/10 mL (13.3 mg/mL) single-dose vial (per Pacira), study administers 3cc bilaterally
15741397|NCT04930887|Drug|Saline|Prescription medicine used for fluid and electrolyte replenishment for intravenous administration; Exparel-matched Placebo treatment
15741398|NCT04930874|Other|NIRS (Near-Infrared Spectroscopy)|NIRS assessment of cerebral autoregulation and cerebral blood flow
15741399|NCT04930861|Drug|Covidir injections|administration of the investigational product CODIVIR at a dose of 20 mg twice a day subcutaneously.
15741400|NCT04930861|Diagnostic Test|One Step Test|rapid test for the diagnosis of COVID-19 based on the detection of anti-SARS-CoV-2 in the blood.
15741401|NCT04930861|Diagnostic Test|IgM and IgG dosage|blood collection for dosage of Anti SARS-CoV-2 antibodies.
15741402|NCT04930861|Diagnostic Test|RT-PCR SARS-CoV-2|detection of viral RNA in nasopharyngeal and oropharyngeal samples by the Real Time Protein Chain Reaction technique.
15741403|NCT04930861|Diagnostic Test|Screening blood test|complete blood count, urea, creatinine, uric acid, sodium, potassium, chloride, calcium, glucose, glycated hemoglobin, alkaline phosphatase (FA), alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubins and fractions ( BTF), total proteins and fractions (PTF), lipid profile (total cholesterol, fractions and triglycerides); coagulogram (TP, aPTT); D-dimer; C-reactive protein; HIV, HBV, HCV serology; Ferritin; fibrinogen, Pregnancy test for non-sterile women.
15741404|NCT04930861|Diagnostic Test|ECG|12-lead electrocardiogram with report.
15741405|NCT04930861|Diagnostic Test|Medical evaluation|evaluation by the principal investigator or assistant physician with a complete physical examination.
15741406|NCT04930861|Diagnostic Test|NEWS-2 score|assessment of the participant by the NEWS-2 score.
15741407|NCT04930861|Diagnostic Test|WHO score|assessment of the participant by the score of the World Health Organization.
15741408|NCT04930848|Other|Euphorbia hirta (Dudhiya)|Duration of the intervention was 2 consecutive weeks or 14 days. In each evening, one teaspoon full (3gm) powder should be mixed with two cups of water and boiled. When it becomes half(one cup), have to add one teaspoon of sugar and drink it as tea.
15741409|NCT04930848|Other|PBO(Combined powder of Terminalia arjuna and Terminalia bellerica)|Duration of the intervention was 2 consecutive weeks or 14 days. In each evening, one teaspoon full (3gm) powder should be mixed with two cups of water and boiled. When it becomes half(one cup), have to add one teaspoon of sugar and drink it as tea.
15741410|NCT04930835|Procedure|Implant supported dentures|Placement of dental implants with different loading protocols for supporting full arch dentures.
15741411|NCT04930822|Other|Table Top Visual Intervention|Table top visual interventions and exercises.
15741412|NCT04930822|Device|Bioness Integrated Therapy System Visual Intervention|Digital visual interventions and exercises.
15741413|NCT04930809|Drug|VER-01|standardised cannabis extract (containing 21 mg THC per gram drug product)
15741414|NCT04930796|Drug|VER-01|standardised cannabis extract (containing 21 mg THC per gram drug product)
15741415|NCT04930783|Drug|CDX-301|Administered as an injection given underneath the skin
15741416|NCT04930783|Biological|NEOVAX|Personalized neoantigen vaccine administered as an injection given underneath the skin
15741417|NCT04930783|Drug|Nivolumab|Administered intravenously (IV)
15741418|NCT04930770|Drug|MRNA-1273|Renal or renopancreatic transplant's patient will receive a third dose of mRNA 1273 (Moderna) vaccine from 28 days after administration of the second dose and after the seronegativity has been verified.
15741419|NCT04930744|Drug|Isoniazid|Isoniazid, dose prescribed by participant's physician, will be taken by mouth daily. Isoniazid, is in a combination pill pack with the other standard ATT medications.
15741420|NCT04930744|Drug|Rifampicin|Rifampicin, dose prescribed by participant's physician, will be taken by mouth daily. Rifampicin is in a combination pill pack with the other standard ATT medications.
15741421|NCT04930744|Drug|Ethambutol|Ethambutol, dose prescribed by participant's physician, will be taken by mouth daily. Ethambutol is in a combination pill pack with the other standard ATT medications.
15741422|NCT04930744|Drug|Pyrazinamide|Pyrazinamide, dose prescribed by participant's physician, will be taken by mouth daily. Pyrazinamide is in a combination pill pack with the other standard ATT medications.
15741423|NCT04930744|Drug|Metformin hydrochoride|Metformin hydrochloride 500 mg tablet once daily starting one week after the initiation of TB treatment, then increasing to study twice daily through study week-12 (11 weeks total metformin treatment).
15741424|NCT04930718|Other|Thumb active Exercises|Active específico exercises; Reeducation program
15741426|NCT04930692|Diagnostic Test|Contrast-enhanced CT lymphography with the periareolar injection of iopamidol|"Patients who meet the inclusion/exclusion criteria will undergo the CT lymphography with periaoreolar injection of a mixture of 4 mL iopamidol and 2 mL of 1% lidocaine hydrochloride. Computed tomographic images will be obtained 1, 3, 5, and 10 minutes after administration of the iopamidol. Following enhancement of the lymphatic duct, the first lymph node to show enhancement will be defined as the SLN.
~No later than 10 days after the CT lymphography patients will receive surgical treatment. During breast cancer surgery identification of the SLN using the ICG-fluorescence method with injection of 2 ml indocyanine green into the skin of the areola and the biopsy of identified SLN will be performed. The comparison of the results of CT lymphography and SLN biopsy will be administrated by the investigator."
15741427|NCT04930679|Drug|Andiabet|Each hard capsule includes: 200mg Gynostemma Pentaphyllum Leaf, 200mg Largerstroemia Speciosa Leaf, 133mg Anemarrhena Asphodeloides Whole
15741432|NCT04930640|Dietary Supplement|SGF200 group|1 times a day, 1 capsule for 1 time, before breakfast meal, for 8 week
15741433|NCT04930640|Dietary Supplement|Placebo|Placebo for 8 week
15741434|NCT04930627|Drug|Empagliflozin|dosis depending on body weight: <20 kg 5 mg 1x/day; 20-40 kg 2 x 5 mg; >40 kg 2 x 10 mg
15741435|NCT04930614|Other|Survey on socio-demographic variables and healthcare-seeking, sexual and drug-using behaviour|Digital survey to estimate the associated risk factors for HIV infections in transgender and non-binary people in Flanders and Brussels (Belgium)
15741436|NCT04930575|Other|Muscle Energy Technique|A biomechanical correction approach can lead to the normalization of spinal curvatures and a decrease in the compressional and tensional stress on joints and soft tissues of the body.
15741437|NCT04930575|Other|Mulligan Technique|"The patient will be in a supportive low back chair, thus cervical region will be in a vertical position (Weight-bearing position) with the therapist position will be behind the patient.
~Then the therapist will move the spinous process up in the direction that must follow the apophyseal joint plane under treatment, that is, toward the eye ball. While sustaining this pain-free accessory glide, the patient will be instructed to actively perform the physiological movement gradually until the end ROM with over pressure at the end of the range."
15741438|NCT04930562|Drug|BN101|BN101 is an orally ROCK2 selective inhibitor
15741445|NCT04930536|Drug|Acalabrutinib capsule|The recommended dose of Acalabrutinib is 100 mg given per oral (PO) twice daily
15741446|NCT04930523|Other|Elongation Longitudinaux Avec Decoaption Osteo Articulaire|"Pre physiotherapy treatment
~Gym (treadmill ,cycling,vibrator) according to ability and condition of patient Shortwave diathermy SWD for atleast 10 mins Decompression treatment i.e. Neuro-oxy motorized lumbar spinal decompression therapy for 25 minutes.
~Post physiotherapy treatment
~Conventional Tens and infrared heat for 10 minutes at low back region. TENS is modality to reduce pain and tension,by stimulating large diameter afferent fiber .IR give superficial heat for circulation and relaxation of muscles.
~No exercises or walk were guided for home (till 24 hrs) Low back exs guided i.e knee to chest, pelvic rolling, bridging, SLR, pirformis exs is guided for home plan along with precautions.
~No exertion ,drive carefully Avoid stairs climbing ,twisting ,bending ,weight lifting"
15741447|NCT04930523|Other|Decompression|"Pre physiotherapy treatment
~Gym (treadmill ,cycling, vibrator) according to ability and condition of patient Shortwave diathermy SWD for at least 10 minutes. ELDOA positions are guided and performed by patients before decompression Low back exercises guided i.e. knee to chest, pelvic rolling, bridging, SLR, piriformis exercises is guided for home plan along with precautions.
~Decoarctation of (C0/C1/C2),(C4/C5),(C5,C6),(C6/C7),(T4/T5),(T6/T7),(T8,/T9),(L4/L5),(L5/S1) Neuro-oxy motorized lumbar spinal decompression therapy for 25 minutes. Post physiotherapy treatment Tens and infrared heat for 10 minutes at low back region. TENS is modality to reduce pain and tension, by stimulating large diameter afferent fiber .IR give superficial heat for circulation and relaxation of muscles.
~ELDOA exercises(positions)are guided for home plan after session (after 24 hrs) No exertion ,drive carefully Avoid stairs climbing, twisting bending, weight lifting"
15741448|NCT04930497|Procedure|vestibular socket technique with bone grafting|a vestibular horizontal incision was made then a subperiosteal tunnel was created and a facial bone membrane was placed. The facial gap was filled with a mixture of autogenous bone and deproteinized bovine bone mineral
15741449|NCT04930497|Procedure|vestibular socket technique without bone grafting|the vestibular incision was done horizontally about 3 to 4 mm apical to the mucogingival junction and extending 5 to 10 mm horizontally. A submucoperiosteal tunnel was created labially from the socket orifice till the vestibular access incision
15741450|NCT04930471|Drug|Metformin|Treatment with Metformin as prescribed by the treating physician.
15741451|NCT04930458|Other|Nanosilver fluoride|Nanosilver fluoride will be applied to the affected tooth in single application and then follow up after one and three months
15741452|NCT04930458|Other|Sodium fluoride with casein phosphopeptides amorphous calcium phosphate|Sodium fluoride with casein phosphopeptides amorphous calcium phosphatewill be applied to the affected tooth in single application and then follow up after one and three months
15741453|NCT04930458|Other|Sodium fluoride varnish|Sodium fluoride varnish will be applied to the affected tooth in single application and then follow up after one and three months
15741454|NCT04930445|Drug|Oxbryta® (voxelotor) 500mg Tablets|Participants will receive treatment with Oxbryta as prescribed by their physician, as part of their usual care. Participants will be treated and evaluated per standard of care (SOC) and at the physician's discretion. There are no pre-defined treatment requirements.
15741455|NCT04930432|Drug|MCLA-129|MCLA-129 will be administered by intravenous infusion.
15741456|NCT04930419|Device|Videolaryngoscopy group|Tracheal intubation will be performed using Videolaryngoscope in first intention and will be performed using standard pre-hospital intubation procedures : preoxygenation before intubation, maintenance of oxygenation throughout procedure, standard sedation technique (using rapid sequence intubation (RSI)), correct position confirmation using a capnogram and conditioning (hemodynamic monitoring, respirator settings, securing). If the first attempt at intubation is unsuccessful, further management will be left to the discretion of the clinician according to the procedures and algorithm of usual standard care
15741485|NCT04930250|Other|Beverage powder with 12% oat bran processed with method C|50g of beverage powder to be reconstituted with 330ml of water. Subjects will orally consume one of the five test products in a random order over the five test visits.
15741712|NCT04928274|Other|telescopic attachment to retain mandibular over denture|each patient in group receive 3 telescopic attachment for over denture retention
15741457|NCT04930419|Device|Direct laryngoscopy group|Tracheal intubation will be performed using Direct laryngoscopy with Macintosh blades in first intention. and will be performed using standard pre-hospital intubation procedures : preoxygenation before intubation, maintenance of oxygenation throughout procedure, standard sedation technique (using rapid sequence intubation (RSI)), correct position confirmation using a capnogram and conditioning (hemodynamic monitoring, respirator settings, securing). If the first attempt at intubation is unsuccessful, further management will be left to the discretion of the clinician according to the procedures and algorithm of usual standard care
15741458|NCT04930406|Other|Physical therapy|Had to receive 10 or more visits of physical therapy during the cancer treatment period to qualify for intervention group.
15741459|NCT04930393|Procedure|Nerve Block - either PECS II or axillary ring|In addition to an interscalene nerve block, one of these two interventions will be administered to assess pain control after a biceps tenodesis
15741460|NCT04930380|Other|phone interview|Cases and controls will receive a phone interview
15741461|NCT04930367|Behavioral|Radio Ads|Engaging radio mini shows that address community stigma and medical literacy through busting common myths with humor and building empathy with heartfelt storytelling.
15741462|NCT04930367|Behavioral|Community Sensitization Campaign|Large-scale, infographic billboards and posters located in public areas and secondary schools to address stigma, medical literacy and promote community support for AYAHIV.
15741463|NCT04930367|Behavioral|Informational Posters|Large-scale, infographic posters located in clinic waiting areas to normalize HIV and build confidence in treatment.
15741464|NCT04930367|Behavioral|Motivation Walls|Interactive, patient-generated posters located in the consultation room where patients can post words and phrases about themselves and their futures.
15741465|NCT04930367|Other|Pill Container|A discreet pill container to support ART adherence.
15741466|NCT04930367|Other|CombinADO-specific training for healthcare workers|Comprehensive in-service training for healthcare workers focused on the needs of adolescents and young adults living with HIV
15741467|NCT04930367|Other|One Stop Shop Model of Care|Model of care that allows adolescents and young adults living with HIV to access a complete set of services, including HIV care, in one central location.
15741468|NCT04930367|Other|Treatment Toolkit|A guide to clinic visits and discussions on ART and viral load monitoring to help healthcare workers better communicate with patients.
15741469|NCT04930367|Other|Self-reflection Kit|A simple handout for healthcare workers to help patients reflect on their ART progress and understand the concept of viral load as a measure of ART success.
15741470|NCT04930367|Behavioral|Peer Support|Peer exposure to examples of adolescents and young adults openly living with HIV (AYAHIV) and; opportunities to share their experiences with HIV in one-on-one interactions with other AYAHIV during clinic visits.
15741471|NCT04930367|Behavioral|Informational and motivational Video|An informational and motivational video that in simple language with engaging graphics that a) demystifies and simplifies HIV, ART, and viral load and; b) emphasizes that people can live long, healthy lives.
15741472|NCT04930367|Behavioral|Support groups- caregivers of adolescents and young adults living with HIV|A learning, support, and empowerment group for caregivers of adolescents and young adults living with HIV (AYAHIV). Through monthly gatherings, the program aims to foster confidence, and equip caregivers with strategies to support AYAHIV adherence journey.
15741473|NCT04930367|Behavioral|Support groups- adolescents and young adults living with HIV|A peer-to-peer learning, support, and empowerment group to address loss of hope and improve medical literacy. Through biweekly gatherings, the program aims to foster belonging and confidence, equipping young people and caregivers with strategies to navigate the adherence journey.
15741474|NCT04930367|Behavioral|Mental health screening and linkage to adolescent-focused mental health support|HCWs will be trained in the use of a brief mental health screening tool focusing on depression, anxiety, and post-traumatic stress disorder. Mental health service providers at each facility will be trained and supported to provide diagnostic and mental health support to youth with positive screens who agree to further evaluation.
15741475|NCT04930354|Drug|ECP-1014|Patients will be selected who (1) have failed all standard of care therapy (relapsed/refractory) or (2) have relapsed and are not a candidate for an available standard of care therapy as assessed by the investigator (such as, but not limited to, colorectal cancer (CRC), Non-Small Cell Lung Cancer (NSCLC), head and neck, etc.) with COX-2 overexpression, ultimately resulting in elevated production of prostaglandin E2 (PGE2).
15741476|NCT04930341|Other|Self-Acupressure|Acupressure is a therapy method performed with an instrument or hand, fingertip, palm, elbow, knee, thumb relaxation and wrist bands on various points representing the waist organs in order to ensure the continuation and balance of the energy in our body.
15741478|NCT04930315|Drug|Apatinib Mesylate|250mg, po, qd, q2w in neoadjuvant and adjuvant group, before surgery
15741479|NCT04930315|Drug|Camrelizumab|200mg, iv, d1, q2w, both in two groups
15741480|NCT04930289|Device|LungGuard|The LUNGguard is an FDA cleared and is a CE-marked medical device intended to be used for the static hypothermic preservation of lungs during transportation and eventual transplantation into a recipient using cold storage solutions indicated for use with the lungs. The intended organ storage time for the LUNGguard is up to 8 hours.
15741481|NCT04930276|Other|Diet intervention|Professionals will guide participants to have a standard diet and require them to monitor blood glucose by themselves.
15741482|NCT04930263|Behavioral|walking exercise|The intervention was 24 weeks walking exercise program. Participants exercised frequency at 5 sessions a week for 30 minutes per section with moderate-intensity and wearable device assisted. Each session consisted of a 5 minutes warm-up, moderate-intensity walking exercises and 5 minutes cool-down.To monitor participant's compliance, we will provide diary book, biweekly phone call, and monthly home visit.
15741483|NCT04930250|Other|Beverage powder with 12% oat bran processed with method A|50g of beverage powder to be reconstituted with 330ml of water. Subjects will orally consume one of the five test products in a random order over the five test visits.
15741484|NCT04930250|Other|Beverage powder with 12% oat bran processed with method B|50g of beverage powder to be reconstituted with 330ml of water. Subjects will orally consume one of the five test products in a random order over the five test visits.
15741486|NCT04930250|Other|Placebo Comparator: Minimally-processed oat bran (Positive Control)|50g of beverage powder to be reconstituted with 330ml of water. Subjects will orally consume one of the five test products in a random order over the five test visits.
15741487|NCT04930250|Other|Placebo Comparator: Readily-digestible carbohydrate (negative control)|50g of beverage powder to be reconstituted with 330ml of water. Subjects will orally consume one of the five test products in a random order over the five test visits.
15741488|NCT04930237|Drug|Relistor Injectable Product|12-mg RELISTOR to be administered as once-daily subcutaneous injections for 4 to 7 days
15741489|NCT04930237|Drug|Docusate Calcium|Standard of care
15741490|NCT04930237|Drug|Bisacodyl|Standard of Care
15741491|NCT04930237|Drug|Milk of magnesia|Standard of Care
15741492|NCT04930237|Drug|Magnesium citrate|Standard of Care
15741493|NCT04930237|Drug|Senna|Standard of Care
15741494|NCT04930237|Drug|Enema|Standard of Care
15741495|NCT04930224|Diagnostic Test|The effect of GPER-1 on the formation of diabetic retinopathy|Demonstrating the neuroprotective effect of GPER-1 in the formation of diabetic retinopathy and being a guide for new treatment models
15741496|NCT04930211|Drug|Dexamethasone-Lidocaine|Kambin's triangle approach in transforaminal epidural injection: Kambin's triangle is defined as a right triangle over the dorsolateral disc. The hypotenuse is the exiting nerve root, the base is the superior border of the caudal vertebra, and the height is the dura/traversing nerve root. it is possible to inject agents at the entrance and middle zone as the main areas of nerve entrapment by injecting at the retrodiscal area of the entrance zone, as proximal area of the targeted nerve root.
15741497|NCT04930198|Behavioral|PeerNaija|All participants (N=50) will receive daily medication reminders and access to the virtual support group on the PEERNaija app. Participants will be randomized to receive a social incentive (n=25) or a social plus financial incentive (n=25), PEER+, and be followed for 24 weeks.
15741498|NCT04930185|Behavioral|Reducing Vaccine Hesitancy (VH) And Vaccine Refusal (VR): An Educational Intervention Programme|"Participants will be receiving the pamphlet about the COVID-19 vaccination information during the intervention.
~They will received 3 different sets of questionnaire to measured their level of vaccine hesitancy and vaccine refusal in 3 different time points: (a) before intervention, (b) after the intervention, and (c) 3 months after the intervention.
~Data cleansing will be conducted based on the per-protocol analysis. Pre-protocol is a comparison of treatment groups that includes only those patients who completed the treatment originally allocated."
15741499|NCT04930185|Behavioral|Reducing Vaccine Hesitancy (VH) And Vaccine Refusal (VR): An Educational Intervention Programme|"Participants will be receiving the webinar last for half an hour about the COVID-19 vaccination information during the intervention.
~They will received 3 different sets of questionnaire to measured their level of vaccine hesitancy and vaccine refusal in 3 different time points: (a) before intervention, (b) after the intervention, and (c) 3 months after the intervention.
~Data cleansing will be conducted based on the per-protocol analysis. Pre-protocol is a comparison of treatment groups that includes only those patients who completed the treatment originally allocated."
15741500|NCT04930185|Behavioral|Reducing Vaccine Hesitancy (VH) And Vaccine Refusal (VR): An Educational Intervention Programme|"Participants will be receiving the SMS about the COVID-19 vaccination information during the intervention.
~They will received 3 different sets of questionnaire to measured their level of vaccine hesitancy and vaccine refusal in 3 different time points: (a) before intervention, (b) after the intervention, and (c) 3 months after the intervention.
~Data cleansing will be conducted based on the per-protocol analysis. Pre-protocol is a comparison of treatment groups that includes only those patients who completed the treatment originally allocated."
15741501|NCT04930172|Device|Steerable introducers|endografts via total transfemoral approach for visceral vessels cannulation
15741502|NCT04930159|Behavioral|Facilitated group support|Weekly group gatherings where content will alternate between group conversation and focused topics (e.g., treatment side-effects, mental health, family dynamics, nutrition, financial hardship) with facilitated discussion by a trained professional in nutrition, psychotherapy, cognitive behavioral therapy, or medicine. Each group will cycle through the same order of topics.
15741503|NCT04930159|Behavioral|1:1 Peer Support|1:1 peer support via telephone or video either during or near a treatment visit. Call content will be focused on social support and driven by the needs of the participant.
15741504|NCT04930146|Other|acupuncture and bloodletting|bloodletting at the well points of both hands and feet and acupuncture in DU26, DU24 3 times per week for 4 weeks, total 12 treatments.
15741505|NCT04930133|Drug|Gilotrif|This is non-interventional, multi-center, multi-cohort study based on existing data from EGFR sensitizing mutation-positive NSCLC patients treated with afatinib as the first-line treatment. Enrolled patients will be categorized into four cohorts (cohort A, B, C and D) according to the type of second line treatment with biopsy results before start of second line treatment.
15741506|NCT04930120|Other|Inter ICU long distance patient transfer|Individual or grouped transportation between ICU of severely ill patients using ambulance, plane, helicopter, train or boat, with specialist medical assistance.
15741507|NCT04930107|Drug|Fluconazole 150 mg|Treatment will be offered to participants if clinical exam and clinical samples are consistent with vulvovaginal candidiasis (VVC). Females presenting with a suspected first-time yeast infection will be treated with fluconazole 150 mg orally.
15741508|NCT04930107|Drug|Boric Acid Supp,Vag|Treatment will be offered to participants if clinical exam and clinical samples are consistent with vulvovaginal candidiasis (VVC). Women that have had a prior documented VVC infection that has recurred on fluconazole will be treated with boric acid, 600 mg intravaginally at bedtime for 7 days.
15741509|NCT04930094|Biological|Secukinumab 300 mg|Secukinumab 300 mg
15741510|NCT04930094|Other|Placebo|Placebo
15741511|NCT04930081|Behavioral|Positive Parenting Program, Mindful Parenting|"The Positive Parenting Program (Triple P) consists of 5 weekly group sessions (each lasting for 2 hours) plus three weekly individual telephone interview sessions (each lasting for around 20 minutes). Program materials is available in Chinese.
~The Mindful Parenting program consists of 8 weekly group sessions, each lasting for 2 hours. Programme materials have already been translated into Chinese by local partners of the programme developer."
15741702|NCT04928339|Other|Saline|25mL saline control
15741703|NCT04928326|Diagnostic Test|CorWatch|Non-invasive wearable monitor for the assessment of central venous pressure
15765287|NCT04734197|Drug|Mycophenolic Acid 0.1%|topical immunosuppressant
15741512|NCT04930068|Other|low caloric diet|A low-calorie diet is a structured eating plan that restricts daily caloric intake, commonly for weight loss. Following a low-calorie diet typically means consuming around 1,200 to 1,500 calories per day, which creates a calorie deficit that can lead to weight loss. A low-calorie diet can be effective, but it requires a lot of discipline to work and be safe.
15741513|NCT04930055|Biological|COVID-19 Vaccination|Subjects will receive either the Moderna (mRNA-1273), Pfizer (BTN162b2), or Janssen (Ad26.COV2.S) vaccination per standard of care
15741514|NCT04930042|Drug|Stelara|AVT04 or Stelara (45 mg/5ml) will be administered as a subcutaneous injection in the thigh or abdomen per the approved dosing regimen for moderate to severe chronic PsO for patients with a body weight ≤100 kg.11,12
15741515|NCT04930042|Drug|AVT04|AVT04 or Stelara (45 mg/5ml) will be administered as a subcutaneous injection in the thigh or abdomen per the approved dosing regimen for moderate to severe chronic PsO for patients with a body weight ≤100 kg.11,12
15741516|NCT04930029|Other|Ten year evaluation|Clinical, biological and endoscopic evaluation
15741517|NCT04930016|Behavioral|Quality of life diagnosis and therapy during the completed RCT DIQOL|Quality of life measurement, diagnosis, and tailored therapy (pain therapy, psychotherapy, social support, nutrition, stoma care, physiotherapy, fitness)
15741518|NCT04930003|Biological|QazCoVac-P -COVID-19 Subunit Vaccine|QazCoVac-P (Subunit) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan
15741519|NCT04930003|Other|Placebo|The use of placebo: intramuscularly, twice, spaced 21 days apart, at a dose of 0.5 ml (22 volunteers)
15741520|NCT04929990|Behavioral|Respiratory muscle training|Inspiratory and expiratory muscle training were performed using a breathing trainer (Dofin DT11/14, Galemed Co. Ltd, Taiwan) for 30 minutes a day with a total of eight weeks. Before the training, the MIP and maximal expiratory pressure (MEP) were documented by the best performance of three trials with a digital pressure gauge (GB60, Jitto International Co. Ltd, Taiwan)
15741521|NCT04929977|Device|Wearable device with smart mobile phone|The wearable device will act as a sensor designed to identify critical parameters such as Kangaroo Mother Care adherence and temperature of the infant 24/7 and of the mother-infant pairs during these sessions.
15741522|NCT04929964|Procedure|MRM , Toilet Mastectomy , BCS|MRM , modified radical mastectomy : removing breast and axilla toilet mastectomy : palliative removal of tumor load BCS ,Breast conservative surgery
15741523|NCT04929951|Procedure|Micro Fragmented Adipose Tissue|Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection
15741524|NCT04929951|Procedure|Corticosteroid injection|Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.
15741525|NCT04929938|Behavioral|Unified Protocol for Transdiagnostic Treatment of Emotional Disorders|This is a combination of cognitive-behavioural techniques oriented to improve the emotional regulation. The Unified Protocol is comprised of 8 modules and it is applied following The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders Manual (Barlow, 2017).
15741526|NCT04929925|Diagnostic Test|serum procalcitonin in acute bacterial meningitis|Serum Procalcitonin estimation will be done by Cobas e411Roch diagnostic,Switzerland apparatus by immunoassay method (electrochemiluminescence immunoassay) by using sample serum or plasma heparin or EDTA with reference range less than 0.5ng/ml ( no sepsis) but 0.5-2ng/ml)follow up is recommended) and more than 2 (sepsis)
15741527|NCT04929899|Behavioral|Bright Ideas - CIN Training|Bright IDEAS is a validated problem-solving skill training intervention.
15741528|NCT04929873|Behavioral|Closed transdyser|When the average arterial pressure ≥ 50mmHg, it is indicated that the basic blood supply of the lower extremities is satisfied without special treatment, and when the average arterial pressure < 50mmHg, it indicates insufficient perfusion, by adjusting the pipe position, changing the ECMO flow rate, and properly clamping the artery end to divert part of the blood flow to the side branch circulation, so that the average arterial pressure is maintained above 50mmHg.
15741529|NCT04929873|Behavioral|Routine monitor|Obtain oxygen saturation, skin color, temperature, etc
15741530|NCT04929860|Behavioral|social marketing campaign|social marketing campaign delivered over 4 weeks in 4 separate sessions
15741531|NCT04929847|Other|Self-prepared emollient|The emollient is hypo-allergenic, free of perfume and has very high hydrating capacities together with antioxidants.
15741532|NCT04929834|Other|Hydrating emollient + body lotion for immunotherapy-related side effects|Hydrating, hypo-allergenic, and anti- itching emollient and body lotion for immunotherapy-related skin reactions
15741533|NCT04929821|Device|Biliary Duct Stenting|UNITY-B Balloon-expandable Biodegradable Biliary Stent deployment in obstructed biliary ducts.
15741534|NCT04929808|Other|Hydrating emollient for acute radiodermatitis|"The emollient has a calming effect, and hydrating and anti-oxidative properties.
~An absorbable wound dressing will be applied on painful and moist wounds. In case of severe itch, a systemic antihistaminic agent can be prescribed by the radiotherapist."
15741535|NCT04929808|Other|Standard institutional skin care|The control patients will receive the institutional standard skin care, which includes the application of Flamigel® (Flen Pharma, Kontich, BELGIUM). In addition, Mepilex® (Mölnlycke Health Care, Berchem, Belgium), an absorbable wound dressing will be applied on painful and moist wounds. In case of severe itch, a systemic antihistaminic agent can be prescribed by the radiotherapist.
15741536|NCT04929795|Behavioral|Rhythmic auditory stimulation (RAS)|"The song named 'Sign of The Times' is played and recorded by the research personnel beforehand. The beat of the song will serve as RAS. The computer software Audacity will be used to adjust tempi of RAS. Before intervention, the participant is required to execute the movement task without the aid of RAS as quickly as possible for 30 seconds, so that we obtain his/her baseline movement tempo. For each 40-minute training session in the first training week, three RAS tempi will be provided for the first, second, and last 10 minutes with a five-minute break in between: normal (100% of the baseline tempo), quick (105% of the baseline tempo), and fast (110% of the baseline tempo). With each training week, the three RAS tempi will be increased by 5%. Participants in the experimental groups are required to use their right hand to pick up beads from source bowls to the target bowl when listening to the song. The 3-week intervention program will include 21 40-minute daily training sessions."
15741537|NCT04929795|Behavioral|no RAS|The training protocol will be the same as that used in the experimental group except the lack of RAS during execution of the movement task.
15741704|NCT04928313|Drug|Glatiramer Acetate|Cinnomer® was injected subcutaneously 3 times per week at least 48 hours apart.
15741538|NCT04929782|Device|Resin-based sealant|Etching with 37% phosphoric acid for 30 s (i-GEL N, i-dental, Lithuania), rinsing for 30 s with air-water spray and drying with oil-free air for 15 s, resin sealant (Conceal F, SDI, Australia) application into the occlusal and buccal/palatal pits and fissures with direct placement syringe system and light curing with 460-500 nm wavelength halogen light unit (Hilux Dental Curing Light Unit 250, Benlioğlu Dental Inc, Turkey) for 20s on each surface.
15741539|NCT04929782|Device|Giomer sealants|Self-etch primer (BeautiSealant Primer, Shofu, Japan) application to the occlusal and buccal/palatal pits and fissures with fine microbrush and waiting for 5 s, homogenizing the bond layer with gentle air stream for 5 s, giomer sealant application (BeautiSealant Paste, Shofu, Japan) with direct placement syringe system and light curing with 460-500 nm wavelength halogen light unit (Hilux Dental Curing Light Unit 250, Benlioğlu Dental Inc, Turkey) for 20 s on each surface.
15741540|NCT04929769|Other|Total Laparoscopic or Robotic Radical Hysterectomy|Radical hysterectomy with bilateral pelvic lymph node dissection is performed as standard type C RH by Q-M classification, including cardinal ligaments divided at pelvic sidewall and uterosacral ligaments divided at near the sacral origin and the upper 1/4 to 1/3 of the vagina.
15741541|NCT04929769|Other|Total Abdominal Radical Hysterectomy|Radical hysterectomy with bilateral pelvic lymph node dissection is performed as standard type C RH by Q-M classification, including cardinal ligaments divided at pelvic sidewall and uterosacral ligaments divided at near the sacral origin and the upper 1/4 to 1/3 of the vagina.
15741542|NCT04929756|Behavioral|Visual Feedback|Gaze-contingent visual feedback
15741543|NCT04929743|Device|BTI Implant|Placement of dental implants of 4.5 vs 6.5 mm length
15741544|NCT04929730|Other|Nephrology care bundle|Nephrology care bundle
15741545|NCT04929717|Other|Breastfeeding education and counseling|Breastfeeding education was applied for four weeks.
15741546|NCT04929717|Other|Routine postpartum breastfeeding training included in the hospital procedure|The routine breastfeeding postpartum educational training given to all women by healthcare personnel as part of the hospital procedures.
15741547|NCT04929691|Device|CPAP helmet|helmet-based CPAP ventilation for eligible patients; assess the feasibility and acceptability of the helmet-based CPAP ventilation
15741548|NCT04929691|Other|Standard of care non-helmet based CPAP ventilation|Standard of care ventilation without helmet-based CPAP
15741549|NCT04929678|Device|Braive™ Growth Modulation System (Braive™ GMS)|"The Braive™ GMS is designed as a growth-modulation, non-fusion technique, which utilizes patients' remaining growth potential to limit further progression of the curve, to provide correction of the thoracic spine, and allow continued growth while maintaining mobility.
~The system consists of the following components: Braid, Fixed Angle Screws (FAS), Plate, and Break-Off Set Screw."
15741550|NCT04929665|Procedure|Two different block and combination of these two blocks|Thoracic paravertebral block, erector spina block, and a combination of paravertebral block and erector spinae block will be applied to the patients under real-time ultrasound guidance.
15741551|NCT04929652|Drug|Surufatinib,Camrelizumab,Irinotecan,GM-CSF|"Dose climbing stage design (n=12) :
~Surufatinib: Oral, 3w.The initial dose of 250mg/ day (n=6) : If 2 out of 6 patients developed > DLT in the first treatment cycle, the exploratory dose was 200 mg/ day; if ≤2 out of 6 patients developed DLT, the exploratory dose was 300mg/ day (n=6);At the next dose phase, if 2 out of 6 patients with > developed DLT, the previous dose was recommended or the study was terminated;If no more than 2 out of 6 patients developed DLT, the dose was the recommended dose；PD-1,200mg, iv,D1, 3w；Irinotecan: 200mg/㎡, iv, D1, 3w；GM-CSF,D2, D3, D4, D5, D6 and D7 in the first week of each cycle ；
~Dose expansion phase design(n=36):
~Surufatinib: Oral, 3w. the dose was set according to the recommended dose in the dose climbing stage;
~PD-1(Camrelizumab) : 200mg, iv,D1, 3w;
~Irinotecan: 200mg/㎡, iv, D1, 3w;
~GM-CSF: continuous administration of D2, D3, D4, D5, D6 and D7 in the first week of each cycle, 5ug/kg once per body weight, once a day, 3w."
15741552|NCT04929639|Other|measurment of intraabdominal surgery|Immediately after intubation, while the patient is lying in the supine position, an intra-abdominal measurement will be made from the bladder catheter and recorded. Then, after the surgical site antisepsis, when the trocar required for the operation is placed by the general surgeon, another measurement will be made from the trocar port. Measurements will be recorded.
15741553|NCT04929626|Drug|Magnesium Sulfate 500 mg/ml+ ventolin|3 doses of magnesium sulphate i.e; 250mg(0.5ml), 500mg(1ml), 750mg(1.5ml) will be used in nebulized form
15741554|NCT04929626|Drug|Ventolin|it will be given to control group in nebulized form after every 20 min in 1st hour
15741555|NCT04929613|Behavioral|Mindfulness-Based Resilience Training|2.5-day intensive MBRT training sessions.
15741556|NCT04929600|Drug|sacubitril/valsartan|Sacubitril/valsartan oral tablets (200mg) one pill a day + matching placebo of amlodipine one pill a day.
15741557|NCT04929600|Drug|Amlodipine|Amlodipine oral tablets (5mg) one pill a day + matching placebo of sacubitril/valsartan one pill a day.
15741558|NCT04929587|Other|This is a observational research, there is no intervention|This is a observational research, there is no intervention
15741559|NCT04929574|Diagnostic Test|Echocardiogram and Hematological Analysis|Echocardiogram and Hematological Analysis
15741560|NCT04929561|Behavioral|Video-conferencing group|No intervention
15741561|NCT04929548|Drug|Pyrotinib Maleate Tablets|Addition of Pyrotinib in the EC phase to the standard treatment EC-THP regimen recommended by the guidelines.
15741562|NCT04929535|Drug|Hydrogen Peroxide 30 % Topical Solution|Patients will be seen by the radiation therapists involved with the study after randomization. Prior to application of hydrogen peroxide solutions, the patients' lesions will be prepared and debrided of keratinous debris and oils using sterile 70% isopropyl alcohol. Then, the appropriate hydrogen peroxide solution (30% for Arm 1 or 3% for Arm 2) will be rubbed into the lesion and a 1cm border all around the lesion until blanching of the lesion is observed. Hydrogen peroxide will be reapplied after one hour. This process will be repeated weekly for three additional applications for this study. If there is complete clinical response, further hydrogen peroxide will not be done. Patients will be accessed for definitive treatment 4 weeks later.
15741563|NCT04929522|Procedure|local anesthesia|technique for local anesthesia
15741564|NCT04929509|Other|self-assembling peptide|each Curodont Repair applicator unit contains both Curolox technology for guided enamel regeneration and water for activation of the device, each box contains 10 applicators
15741705|NCT04928300|Drug|Dexmedetomidine|low dose dexmedetomidine infusion 0.2 µ/kg/hour IV for 5 days.
15741565|NCT04929509|Other|nanosilver fluoride varnish|The synthesis of aqueous solution of silver nanoparticles will be carried out via the chemical reduction of silver nitrate (1 mL, 0.11 M) with sodium borohydride (0.3 mL, 0.8 M) and chitosan biopolymer (28.7 mL, 2.5 mg/mL) as a stabilizing agent. Sodium fluoride (10,147 ppm of fluorine) will be incorporated at the end of the experiment.
15741566|NCT04929509|Other|sodium fluoride varnish|5% sodium fluoride varnish; One ml of fluoride varnish contains 50 mg of sodium fluoride in an alcohol-based suspension of resins.
15741567|NCT04929496|Procedure|post-PCI FFR|final invasive physiology measurements after successful stent implantation, followed by functional optimization if physiology indexes remain positive.
15741568|NCT04929483|Drug|BIO89-100|Subcutaneous injection
15741569|NCT04929470|Device|cochlear implantation|patients receive a cochlear implantation within clinical routine
15741570|NCT04929444|Other|Training on vertigo|"Online training on vertigo management in primary care with a face-to-face session.
~On the one hand, the course will contain theoretical content and clinical cases will be used as the methodology of the course, with feedback paths for each correct or incorrect answer from the students and videos recorded expressly for the course. In addition, there will be a face-to-face session where all participants must perform the diagnostic and therapeutic maneuvers proposed in the course, to evaluate the use of the training and also to standardize the way of doing them for the study"
15741571|NCT04929418|Other|10 km continuous running|Trial participants will perform a 10 km continuous running exercise
15741572|NCT04929418|Other|1.5 km continuous swimming|Trial participants will perform a 1.5 km continuous swimming exercise.
15741574|NCT04929392|Drug|Carboplatin|Given IV
15741575|NCT04929392|Procedure|Endoscopic Biopsy|Undergo endoscopic biopsy
15741576|NCT04929392|Radiation|External Beam Radiation Therapy|Undergo EBRT
15741577|NCT04929392|Drug|Lenvatinib Mesylate|Given PO
15741578|NCT04929392|Drug|Paclitaxel|Given IV
15741579|NCT04929392|Biological|Pembrolizumab|Given IV
15741580|NCT04929392|Procedure|Resection|Undergo surgical resection
15741581|NCT04929379|Drug|Fenofibrate|145 mg oral fenofibrate daily for 76 weeks. Dosage is decreased to 48 mg daily if iGFR is or is estimated to be below 30 ml/min/1.73 m2.
15741582|NCT04929379|Other|Placebo|Inactive tablets identical to fenofibrate
15741583|NCT04929366|Procedure|Hypothermic dialysis followed with routine dialysis|Hypothermic dialysis (35.5 degrees Celsius dialysate) followed with routine dialysis (36.5 degrees Celsius dialysate)
15741584|NCT04929366|Procedure|Routine dialysis followed with hypothermic dialysis|Routine dialysis (36.5 degrees Celsius dialysate) followed with hypothermic dialysis (35.5 degrees Celsius dialysate)
15741585|NCT04929353|Other|Systematic symptom assessment|"Systematic symptom assessment
~Conventional symptom assessment"
15741586|NCT04929340|Other|Probiotic bacteria|The children are randomly allocated to a test or a control group with aid of computer-generated numbers at the time of consent. After the treatment, children in the test group are given 5 drops per day containing probiotic bacteria (Lactobacillus reuteri Protectis DSM 17938, Biogaia AB, Sweden) before bedtime. One dose consists of a minimum of 100 million live bacteria. Children in control group are given 5 drops per day (containing no bacteria).
15741587|NCT04929340|Other|Placebo|Children in control group are given 5 drops per day (containing no bacteria).
15741588|NCT04929327|Procedure|Self etch Pit and fissure sealant application (prevent seal)|Sealing deep pits and fissures
15741589|NCT04929327|Procedure|Self etch Pit and fissure sealant application (prevent seal) with prior sandblasting|Sandblasting before Sealing deep pits and fissures
15741590|NCT04929327|Procedure|Total etch resin based sealant ultraseal xt|Sealing deep pits and fissures
15741591|NCT04929314|Behavioral|Systematic Interactive Communication Model to Strengthen Self-Care Regardless of Health Literacy Level|The central element of the intervention is the interactive communication model. A website that contains easy-to-understand knowledge and material about various chronic diseases such as chronic obstructive pulmonary disease, diabetes, heart failure, as well as knowledge and material about wound care, compression treatment and prevention of infections has been developed. Information within each topic is given based on the interactive communication model. The idea is that community nurses should not themselves assess what characterizes an easy-to-understand level or the amount of information for each individual citizen, which seeks to ensure a systematic and uniformity in the work with self-care and more self-sufficient citizens. At the same time, the model makes it possible to take into account the individual citizen's knowledge and competencies (level of HL). Further, the nurses receive specialised education regarding HL to complement their use of the interactive communication model.
15741592|NCT04929301|Other|Antenatal milk expression|Hand-expression of breast milk in pregnancy
15741593|NCT04929301|Other|Education handouts|Educational breastfeeding handouts
15741594|NCT04929288|Drug|Alcohol|Participants will complete three experimental sessions. In each session, participants will provide detailed reports of their alcohol consumption over the past five days, and they will provide a blood sample for hormone assays. They will perform tasks during fMRI to assess each of the neurofunctional addiction domains: inhibitory control, negative emotionality, and cue reactivity. Following the fMRI scan, subjects will self-administer intravenous alcohol to provide a controlled assessment of pharmacologically-driven alcohol consumption.
15741595|NCT04929275|Procedure|Enhanced recovery program|12 items of program (preoperative, peroperative postoperative) according to the enhanced recovery after surgery society
15741706|NCT04928300|Drug|Ketamine|low dose ketamine infusion 2.5 µ/kg/min for 5 days.
15741707|NCT04928300|Other|0.9% saline|the same dose and duration of normal saline will be given for 5 days.
15741596|NCT04929262|Behavioral|Supporting Anxious Youth: Strategies for Caregivers|The outreach presentation will last 75 minutes with an additional 15 minutes for caregiver questions. The presentations will occur in the evening via Zoom. The presentation will include information about identifying anxiety disorders, strategies for caregivers to help their youth with anxiety, evidence-based practices to treat youth anxiety, and strategies for finding a therapist who uses cognitive behavior therapy with exposures. The text on the presentations is written at a 5.3 grade reading level. Presentations will incorporate stigma reduction strategies, such as education to dispel myths, and behavioral decision-making tools to elicit hope, empowerment, and motivation.
15741598|NCT04929236|Drug|Panzyga|Intravenous immunoglobulin formulation
15741602|NCT04929210|Drug|Guselkumab|Guselkumab will be administered as subcutaneous injection.
15741603|NCT04929210|Drug|Placebo|Matching placebo will be administered as subcutaneous injection.
15741604|NCT04929197|Device|PERSBRA|"After the patient is in the semi-prone position, the body shape and breast position images are obtained by the stereo scanning technology, and then using 3d printing technology to print PERSBRA.
~PERSBRA maintain a favorable new breast position in the supine position during routine radiotherapy, the cardiopulmonary dose during radiotherapy can be reduced by wearing PERSBRA."
15741605|NCT04929184|Behavioral|Speech and non-speech tasks|Participants will complete speech tasks such as listening to and/or producing speech and non-speech sounds.
15741606|NCT04929171|Other|Physical Therapy|Physical therapy for chronic upper quarter myofascial pain syndrome, as prescribed by the patients' physicians
15741607|NCT04929158|Procedure|Intravascular Ultrasound (IVUS) -guided Primary Percutaneous Intervention (PCI)|Preoperative criminal vascular assessment； The criminal vascular assessment after surgery
15741608|NCT04929106|Device|mHealth support tool|The final app is named Active Leisure and consists of an advanced activity planner based on the platform developed by the ideal company Smart Cognition AS. The app offers different interface options (symbols only, easy to read text, plain text, and read aloud). The activity planner will mostly be used by the individual with IDs and a support person (caregiver or health care provider). After completing an activity, a simple reward is available (e.g., a smiling face or to share a picture with other users of the app). The use of tailored communication through personalization: the use of individuals first name in the activity planner, adaptation: individually chosen activities, adjusted communication (symbols, easy-to-read text or plain text), preparation and planning, and feedback: rewarding and positive feedback (after activities have been performed) is expected to increase motivation, and thereby lead to higher levels of PA.
15741609|NCT04929093|Biological|Novel dose adjustment of Alutard SQ|novel dose adjustment schedule means directly reaching dose of Vial 4, 10,000 SQ
15741610|NCT04929093|Biological|conventional dose adjustment of Alutard SQ|conventional dose adjustment schedule means restarting from dose of Vial 1, 10 SQ
15741611|NCT04929093|Biological|Routine continuous cluster of Alutard SQ|Patient receiving continuous cluster SCIT for DM during the same period
15741612|NCT04929080|Biological|JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion|200mg:JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion
15741613|NCT04929080|Biological|JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion|600mg:JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion
15741614|NCT04929067|Drug|immunotherapy combined with neoadjuvant chemotherapy in patients with locally advanced HPV (-) head and neck squamous cell carcinoma|immunotherapy combined with neoadjuvant chemotherapy in patients with locally advanced HPV (-) head and neck squamous cell carcinoma
15741615|NCT04929054|Diagnostic Test|imaging|ultrasound and contrast enhanced ultrasound for BI RADS4A breast modules
15741616|NCT04929041|Drug|Carboplatin|Given IV
15741617|NCT04929041|Biological|Ipilimumab|Given IV
15741618|NCT04929041|Drug|Nab-paclitaxel|Given IV
15741619|NCT04929041|Biological|Nivolumab|Given IV
15741620|NCT04929041|Drug|Paclitaxel|Given IV
15741621|NCT04929041|Biological|Pembrolizumab|Given IV
15741622|NCT04929041|Drug|Pemetrexed|Given IV
15741623|NCT04929041|Other|Quality-of-Life Assessment|Ancillary studies
15741624|NCT04929041|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15741625|NCT04929028|Drug|Capecitabine|Given PO
15741626|NCT04929028|Drug|Fluorouracil|Given IV
15741627|NCT04929028|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
15741628|NCT04929028|Drug|Mitomycin|Given IV
15741629|NCT04929028|Biological|Nivolumab|Given IV
15741630|NCT04929015|Procedure|Biospecimen Collection - blood and tissue sample collection|The original tissue sample from each patient will be obtained at time of surgery or prior to surgery. Plasma for ctDNA will be obtained at baseline, pre-surgery, post-surgery and every 3 months up 2 years
15741631|NCT04929015|Other|Electronic Health Record Review|Medical record reviewed
15741632|NCT04929002|Other|No intervention|No intervention
15741633|NCT04928989|Other|convergence dialogue meeting|Digital counceling with convergence dialogue tripartite meeting. will be conducted in accordance with work dialogue for return to work. Workplace dialogue among employee with neck problems, an expert in the work environment, and the immediate manager. The purpose of the conversations is, in open dialogue, to reach a common understanding of the situation and identify possible interventions to maintain or improve the employee´s work ability.
15766728|NCT04722458|Other|UDI-6|Urogenital Distress Inventory
15741635|NCT04928950|Drug|Activated charcoal|Activated Charcoal, Powder, USP is carbon that has been treated to create low-volume pores that increase the area available for chemical reactions and adsorption. The most common pharmaceutical uses of activated charcoal is as a purification agent and antitoxin. All Spectrum Chemical USP products are manufactured, packaged and stored under current Good Manufacturing Practices (cGMP) per 21CFR part 211 in FDA registered and inspected facilities.
15741636|NCT04928937|Procedure|Roux-en-Y gastric bypass, sleeve gastrectomy|bariatric surgery with the goal loosing weight
15741637|NCT04928924|Procedure|Total Hip Arthroplasty|We will be observing patients who have undergone surgical replacement of arthritic hip with an implant.
15741638|NCT04928911|Biological|COVID-19 vaccine|Adults about to receive a COVID-19 vaccine fill out a questionnaire of potential predictors of side effect occurrence
15741639|NCT04928885|Behavioral|Wits Workout Program|12 week, one hour per week multi-modal, interactive training.
15741640|NCT04928885|Other|Control Group that receives intervention after the study|The control group will not receive the intervention during study period but will take baseline, 3 mos and 6 mos surveys. They will complete the workshop after the study period is over.
15741641|NCT04928872|Combination Product|Predefined meal|Nine predefined meals are administered in a randomized fashion, one meal per one study day, 2-3 study days per week. Meals have a form of drinks with different compositions of protein, carbohydrates and fat in relation to the US diet
15741642|NCT04928859|Drug|Albumin|"At least one dose of human albumin was used for the patients during hospitalization in the burn ward consisted the albumin group.
~The patients who have no albumin use during their hospitalization in the burn ward consisted the control group."
15741645|NCT04928833|Other|Pilates Training|Pilates training was carried out as group exercises for about 1 hour, 3 days a week for 8 weeks. Before starting the exercise training, all subjects were taught the key elements of Pilates in 1 session. Pilates training started with standing exercises for warming up and centering in the supine position. Training continued with upper and lower extremity movements. The intensity of the exercises was increased using different positions and elastic bands. Stretching exercises and posture exercises were used during the cooling period. All exercises were started with 10 repetitions and then increased to 20. In order for the patients to perform the movements correctly, each movement was first demonstrated by the physiotherapist. The movements that the patients could not do were applied by modifying them in a suitable way.
15741646|NCT04928833|Other|Control group|Breathing exercises, active range of motion exercises and relaxation exercises were given to the control group as a home program. They were asked to do the exercises 3 days a week for 8 weeks.
15741647|NCT04928820|Procedure|Computed Tomography|Undergo PET/CT
15741648|NCT04928820|Other|Gallium Ga 68 Gozetotide|Given IV
15741649|NCT04928820|Procedure|Positron Emission Tomography|Undergo PET/CT
15741650|NCT04928807|Combination Product|Short course radiotherapy sequential camrelizumab and chemotherapy|Short course radiotherapy, 5 * 5Gy, once a day, 5Gy each time, for 5 days, continuous irradiation, three-dimensional 3D-CRT or IMRT technology is recommended camrelizumab 200 mg , D1, intravenous drip, q3w, 2 cycles before operation, postoperative adjuvant treatment, the longest medication time of camrelizumab was less than 1 year during the whole study period; Capecitabine 1000 mg / m2, twice a day, oral, 1-14 days, then rest for 7 days, q3w, 2 cycles before operation and 6 cycles after operation; Oxaliplatin 130 mg / m2, D1, intravenous infusion 2 hours, q3w, 2 cycles before operation, 6 cycles after operation
15741651|NCT04928794|Procedure|Erector Spinae Plane Block|Regional anesthesia with injected local anesthetic solution, placed in space underlying erector spinae muscles
15741652|NCT04928794|Procedure|Paravertebral Block|Regional anesthesia with injected local anesthetic solution, placed in space adjacent to vertebrae
15741653|NCT04928781|Behavioral|Smoking Cessation Counseling|Smoking cessation counseling will be provided following standards set by the institution patients are receiving care at (Dartmouth-Hitchcock Medical Center).
15741654|NCT04928768|Other|Questionnaire|A validated questionnaire (five-point Likert scale) through 10 items developed by Lee et al 2018 is employed to measure the level of orthodontic treatment satisfaction in 10 items; overall satisfaction, tooth alignment, facial appearance, eating and chewing, confident smile and self-image, retention state, treatment duration, treatment costs, intention to recommend, and relief of previous concerns. Total satisfaction is calculated by averaging the Likert scores from the 10 items
15741655|NCT04928742|Behavioral|Group Cognitive Behavioural Therapy (CBT)|The 9-week group CBT intervention for PPD delivered via Zoom by two public health nurses. This intervention was developed by Dr. Van Lieshout (PI) at the Women's Health Concerns Clinic (WHCC) at St. Joseph's Healthcare Hamilton. It was designed to be brief, simple, and applicable to women in community settings. It consists of 9 weekly 2-hour sessions where core CBT skills are learned and practiced, and a new psychoeducational topic is introduced and discussed by women each week.
15741659|NCT04928716|Other|voiding phase evaluation|Assessment of voiding phase in multiple sclerosis patients
15741660|NCT04928703|Drug|Ketamine|Ketamine IV administration
15741661|NCT04928677|Drug|Codrituzumab|For Phase A (Dose Escalation), the starting dose (dose level 1) will be 10 mg/kg with 1 planned dose escalation to 20 mg/kg (dose level 2) if dose level 1 is determined to be safe and tolerable. Once a RP2D/MTD is identified in Phase A, then Phase B (hepatoblastoma expansion cohort) will open and allow for enrollment of up to 10 additional patients.For both phases, patients will receive codrituzumab IV once per week for a period of 21 days per cycle. Patients will be eligible for up to 25 cycles.
15741710|NCT04928274|Other|ball attachment to retain mandibular over denture|each patient in group receive 3 locator attachment for over denture retention
15741711|NCT04928274|Other|locator attachment to retain mandibular over denture|each patient in group receive 3 locator attachment for over denture retention
15741664|NCT04928651|Drug|Clonidine|"Clonidine will be administered to preterm infants in need of analgesia and sedation; either as the primary drug for comfort and light sedation or as an add-on drug to opioids according to an algorithm based on pain and sedative scoring results. Opioids are mostly given to postoperative patients. These drugs (morphine or fentanyl) will not be studied, but a baseline PK sample will be taken to correlate to the baseline aEEG."
15741665|NCT04928638|Behavioral|Virtual educational intervention|Educational intervention about the disease, the use of medication and the context of pandemic
15741666|NCT04928638|Behavioral|Written educational intervention|Educational intervention about the disease, the use of medication and the context of pandemic
15741667|NCT04928625|Drug|SHR-A1904|SHR-A1904
15741668|NCT04928612|Drug|CBP-1018|Strength: 10 mg/vial Dosage form: injection
15741669|NCT04928599|Other|Electronic Health Record Review|Review of medical records
15741670|NCT04928599|Other|Interview|Complete interview
15741671|NCT04928599|Other|Survey Administration|Complete survey
15741672|NCT04928586|Drug|Pirfenidone|CTD-ILD patients treated with pirfenidone up to the maximum tolerable dose
15741673|NCT04928586|Drug|DMARDs|CTD-ILD patients treated with DMARDs according to the condition of the disease
15741674|NCT04928560|Diagnostic Test|SMI|ULTRASOUND
15741675|NCT04928547|Diagnostic Test|Test|Different test
15741676|NCT04928534|Diagnostic Test|Blood tests, Cognitive function tests, head MRI (plain scan and DTI sequence) examination and head PET (FDG-PET, Tau-PET and Amyloid-PET) examination|"Blood tests (30-ml venous blood) for the following items. 1) Transcriptomics and proteomics high-throughput detection and quantitative verification; 2) Exosomal transcriptomics and proteomics high-throughput detection and quantitative verification; 3) Quantitative detection for classical biomarkers of traumatic brain injury, including S100B, GFAP, UCH-L1, NFL, T-Tau and p-Tau181.
~Cognitive function tests, including RPQ, MMSE and MoCA.
~Possible head MRI (plain scan and DTI sequence) examination and head PET (FDG-PET, Tau-PET and Amyloid-PET) examination"
15741677|NCT04928521|Procedure|bilateral erector spinae plane block with 30 mL 0.25 % bupivacaine|Preoperative, awake, bilateral, ultrasound-guided erector spinae plane block with 30 mL 0.25 % bupivacaine
15741678|NCT04928521|Procedure|bilateral erector spinae plane block with 20 mL 0.25 % bupivacaine|Preoperative, awake, bilateral, ultrasound-guided erector spinae plane block with 20 mL 0.25 % bupivacaine
15741680|NCT04928495|Drug|Vitamin C|Vitamin C 500 mg / day for ten days
15741681|NCT04928495|Drug|N-acetylcysteine (NAC)|N-acetylcysteine 1800 mg / day for ten days.
15741682|NCT04928495|Drug|NAC + Bromhexine (BMX)|NAC + Bromhexine (BMX) 32 mg / day for ten days.
15741683|NCT04928482|Behavioral|Backward Walking Training|Participants will receive 27 sessions of backward walking training. Each session wil consist of 20 minutes of gait training on a treadmill and 20 minutes of gait training over ground.
15741684|NCT04928482|Behavioral|Backward Walking Training|Participants will receive 18 sessions of backward walking training. Each session wil consist of 20 minutes of gait training on a treadmill and 20 minutes of gait training over ground.
15741685|NCT04928469|Other|No intervention performed|Collection of clinical and laboratory data
15741686|NCT04928456|Other|Osteopathic Manipulative Treatment (OMT)|Osteopathic Manipulative Treatment (OMT) involves a number of hands-on techniques that are meant to address somatic dysfunction in the body as a part of the osteopathic approach to treating patients. There will be five techniques in total used in the study treatment plan.
15741687|NCT04928443|Other|Scar dressing group|Patients treated with scar dressing for surgical scar care are invited to participate this study and allocated in scar dressing group despite the length of caring period.
15741688|NCT04928443|Other|Regular care group|Patients receiving regular scar care are retrospectively identified with matching factors, such as gender, age, length of surgical wound and surgical procedure.
15741689|NCT04928430|Drug|XAV-19|150 mg of XAV-19 single IV perfusion
15741690|NCT04928430|Drug|Placebo|Single IV infusion
15741691|NCT04928404|Procedure|tongue base suspension using barbed suture|all patients will undergo multi-level surgeries .Therefor, Anterolateral advancement pharyngeoplasty (ALA) or Barbed Reposition Pharyngoplasty (BRP) will be applied to improve retro-palatal obstruction and tongue base suspension using barbed suture for retro-lingual obstruction.
15741692|NCT04928391|Drug|Dexmedetomidine|A single dose of 0.5 µ/kg IV dexmedetomidine at the end of surgery
15741693|NCT04928391|Drug|Nalbuphine|A single dose of 0.1 mg/kg IV nalbuphine at the end of surgery
15741694|NCT04928391|Other|0.9% saline|Same volume of saline placebo IV at the end of surgery
15741695|NCT04928378|Other|Descriptive retrospective study|characterization of the diagnosis, management and outcome of patients with osteoarticular infection due to MDR M. tuberculosis in France (MDR IOATB).
15741696|NCT04928365|Drug|Anti-PD-1 monoclonal antibody|Anti-PD-1 therapy
15741697|NCT04928352|Drug|Bupivacaine Hydrochloride|Preoperative Nebulized Bupivacaine 0.50% 0.25 mg.kg-1
15741698|NCT04928352|Drug|Bupivacaine Hydrochloride|Preoperative Nebulized Bupivacaine 0.50% 0.50 mg.kg-1
15741699|NCT04928352|Other|0.9% saline|Preoperative nebulized same volume of saline placebo
15741700|NCT04928339|Drug|Bupivacaine Injection|10mL of 0.25% bupivacaine
15741701|NCT04928339|Drug|Liposomal bupivacaine|15mL of 133mg liposomal bupivacaine
15741713|NCT04928261|Drug|Trastuzumab|Patients with early-stage HER2-positive breast cancer who demonstrate a pathological complete response at time of surgery will be treated with HER2 targeted therapy for a total of 9 treatments every 3 weeks (or its equivalent if given weekly) including the treatment received preoperatively.
15741714|NCT04928248|Other|Diabetes Dashboard integrated with Disease Manager App|The Diabetes Dashboard is available as a tab in the electronic health record (EHR) system and enables clinicians to confirm relevant patient parameters, select treatment goals, and review likely outcomes from alternative treatment strategies through an interactive graphical user interface. The Diabetes Dashboard is integrated within the diabetes module of the EHR-integrated Disease Manager App, which uses key information from the Diabetes Dashboard and provides a link to the Diabetes Dashboard.
15741715|NCT04928235|Diagnostic Test|Thermal Imaging as Diagnostic Adjunct|Thermal images of the participants lower extremities will be taken and skin surface temperature values will be provided to the healthcare provider for review during the emergency department encounter.
15741716|NCT04928222|Combination Product|Doxorubicin-containing MNA|A 15 square millimeter array containing 400 dissolvable microneedles delivering active agent
15741717|NCT04928222|Drug|Placebo-containing MNA|A 15 square millimeter array containing 400 dissolvable microneedles containing placebo
15741718|NCT04928209|Other|Speech-Language Teletherapy|Access to speech-language teletherapy will be provided as a supplement to Usual Care for subjects randomized to this group. Access is provided by way of 1) direct referral by the clinical team to a teletherapist; 2) availability of a teletherapy slot. All teletherapy providers will be licensed speech-language pathologists (SLPs) and/or credentialed teachers of the deaf (TODs) with specialized training to work with children who are D/HH using an LSL approach. Fluent English and Spanish speaking providers will be matched to the child's home, native language. Teletherapy itself is within routine clinical care and is not considered a research activity. Children who randomize to the Low TT study arm will receive access to an 18-month course of weekly teletherapy, in accordance with the centers' standard of care. The exact details of the therapy course and frequency will be determined based on individual family needs.
15741719|NCT04928196|Other|Microperimtery and optical coherence tomography angiography OCTA|observational: Investigations are done to assess the retinal microvasculature and function before and after silicone oil removal
15741720|NCT04928183|Other|Carbon monoxide rebreathe|Carbon monoxide exposure to increase blood (Carboxyhemoglobin) COHb safely to ~10%
15741721|NCT04928183|Drug|Sodium Nitroprusside|Bolus Sodium Nitroprusside (SNP) injection for endothelium-independent vasodilation measure
15741722|NCT04928183|Drug|Phenylephrine Hydrochloride|Bolus Phenylephrine injection for observe α1-mediated vasoconstriction during mild exercise
15741723|NCT04928157|Device|Positive Airway Pressure (PAP)|A device used with a nose or face mask which delivers airflow/pressure into the airway, holding the airway open and keeping it from collapsing. Device will be used for 8 weeks.
15741724|NCT04928144|Drug|SHJ - Low concentration|Topical ophthalmic
15741725|NCT04928144|Drug|SHJ - Mid concentration|Topical ophthalmic
15741726|NCT04928144|Drug|SHJ - High concentration|Topical ophthalmic
15741727|NCT04928144|Drug|SHJ - Maximum tolerated|SHJ - Maximum tolerated
15741728|NCT04928131|Other|No intervention - retrospective observational cohort study|
15741729|NCT04928118|Other|Evaluate the blood flow and pressure into kidneys|"Renal artery pressure and flow measures will be obtained using dedicated equipment positioned into the renal artery under fluoroscopic guidance.
~A pulmonary artery catheter will be used to measure the pressure inside participant's renal vein and to collect small blood samples to measure oxygen content."
15741730|NCT04928105|Biological|Senl-T7|Patients will be treated with CD7 CAR-T cells
15741731|NCT04928092|Procedure|Standard of care Ultra Low Contrast PCI|PCI using low amounts of contrast media which is standard of care at VCU Medical Center
15741732|NCT04928079|Procedure|deep brain stimulation|performing deep brain stimulation if needed
15741733|NCT04928079|Drug|Anti-Parkinsonian Drugs|Using anti-parkinsonian drugs if needed
15741734|NCT04928066|Drug|Iguratimod|Iguratimod tablet，25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.
15741735|NCT04928066|Drug|Tofacitinib|Tofacitinib,5mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.
15741736|NCT04928066|Drug|Pred|Pred, 0-10mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response.
15741737|NCT04928053|Genetic|ocytocine dosage and genetic analyse|All patients are assessed using 4 paradigms: Reading the Mind in the Eyes Test (RMET), Interpersonal Reactivity Index (IRI), Empathy Quotient (QE), and a modified Delay Discounting task. They have a blood prelevment
15741738|NCT04928040|Diagnostic Test|meausement of optic nerve diameter|fluid challange effects on meausement of optic nerve diameter
15741739|NCT04928014|Other|Melody®|Melody® is a tear-based screening assay for breast cancer developed and validated by Namida Lab, Inc., a high complexity CLIA certified lab. Melody® consists of two parts: tear sample collection and clinical lab test. Melody® is a high-complexity lab-developed test for breast cancer screening.
15741740|NCT04928001|Other|internet based iCBT program, Youth Thrive|iCBT program is a skills program which teaches assertive communication, constructive thinking and rewarding activities
15741741|NCT04927988|Other|Ringer's Lactated|Using of Ringer's Lactated In Autologous Blood Cell Transfusion
15741744|NCT04927962|Other|Questionnaires|For youth: self-reported questionnaires (on oral quality of life, bullying and cyberbullying, dental anxiety) and routine clinical examination for adolescents. For one parent: self-reported questionnaires (on perceived oral quality of life of their child and on their own dental anxiety).
15741745|NCT04927949|Drug|cangrelor perfusion during PCI|Cangrelor perfusion (started before PCI) with intravenous bolus of 30 microgram/kg, followed by a perfusion of 4 microgram/kg/min during 2 hours or until the end of the PCI if longer
15741746|NCT04927949|Procedure|standard PCI|primary PCI without cangrelor
15741747|NCT04927936|Biological|Vaccination once with Janssen vaccine (only priming)|Vaccination (priming) with janssen vaccine. There is no boosting.
15741880|NCT04926844|Drug|Levetiracetam|Intravenous levetiracetam 60 mg/kg (max 4500 mg) over 5 minutes (diluted with isotonic saline to a concentration of 50 mg/ml).
15741748|NCT04927936|Biological|Vaccination with Janssen vaccine followed with Janssen vaccine (homologous boosting).|Vaccination (priming) with janssen vaccine. There is boosting with Janssen vaccine.
15741749|NCT04927936|Biological|Vaccination with Janssen vaccine followed with Moderna vaccine (heterologous boosting).|Vaccination (priming) with janssen vaccine. There is boosting with Moderna vaccine.
15741750|NCT04927936|Biological|Vaccination with Janssen vaccine followed with Pfizer vaccine (heterologous boosting).|Vaccination (priming) with janssen vaccine. There is boosting with Pfizer vaccine.
15741751|NCT04927923|Other|hope-focused motivational interview|The eight-week hope-focused motivational interview will be applied to each individual individually during dialysis treatment. Within the scope of the study, a hope tree will be created for each individual together with the patients to be used in the evaluation process of the interview sessions. Through the hope tree, it is aimed for the individual to set goals, to discover the obstacles and solutions in achieving these goals.
15741752|NCT04927910|Other|Ture self-acupressure|8-week intervention of self-acupressure on acupoints
15741753|NCT04927910|Other|Sham self-acupressure|8-week intervention of self-acupressure on non-acupoints
15741754|NCT04927910|Other|Usual care|routine care by hospitals
15741755|NCT04927897|Diagnostic Test|Ultrasound|3D endorectal ultrasound.
15741756|NCT04927897|Diagnostic Test|Rectoscopy|Rigid rectoscopy.
15741757|NCT04927897|Other|MRI (resection specimen)|For some patients, MR images of the resection specimen (note: NOT of the patients) during the pathological process will be acquired.
15741758|NCT04927884|Biological|N-803|"Dose: 15 μg/kg subcutaneously (SC)
~Frequency: administered on Day 8 of each cycle (every 3 weeks)"
15741759|NCT04927884|Biological|PD-L1 t-haNK|"Dose: ~2 × 10^9 cells intravenously (IV)
~Frequency: administered on Days 1 and 8 of each cycle (every 3 weeks)"
15741760|NCT04927884|Drug|Sacituzumab Govitecan-Hziy|"Phase 1b:
~Dose level 1: Sacituzumab govitecan-hziy (7.5 mg/kg IV) Dose level 2: Sacituzumab govitecan-hziy (10 mg/kg IV) Dose level -1 (if needed): Sacituzumab govitecan-hziy (5.0 mg/kg IV)
~Phase 2: Dose based on Phase 1b Recommended Phase 2 Dose (IV)
~Frequency: administered on Days 1 and 8 of each cycle (every 3 weeks)"
15741761|NCT04927884|Drug|Cyclophosphamide|"Dose: 25 mg capsules taken twice per day by mouth (PO)
~Frequency: to be taken Days 1-15 and 15-19 of each cycle (every 3 weeks)"
15741762|NCT04927871|Behavioral|Total Diet Replacement (TDR)|The nutritionist will provide a total diet replacement (TDR) with Low-Energy Liquid-Diet (LELD - 811 kcal/day, 64 g protein, 132 g carbohydrate, 6 g fat) and the food reintroduction for two months.
15741763|NCT04927871|Behavioral|Medical Nutritional Therapy (MNT)|The nutritionist will provide Medical Nutritional Therapy (MNT) using the transcultural Diabetes Nutritional Algorithm (tDNA) Toolkit adapted for Venezuela for four months.
15741764|NCT04927871|Behavioral|Diabetes Prevention Program 4 months|The coach will provide a group-based Diabetes Prevention Program (DPP) version in weekly encounters during 4-months.
15741765|NCT04927871|Behavioral|Diabetes Prevention Program|The coach will provide a group-based Diabetes Prevention Program (DPP) version in weekly encounters during 6-months.
15741766|NCT04927858|Drug|Empagliflozin|Empagliflozin
15741767|NCT04927845|Behavioral|StriveWeekly|"The intervention (app.striveweekly.com) delivers content via independent modules. Principles covered in content modules: Psychoeducation; Self-monitoring; Values-based goal-setting; Behavioral activation; Cognitive restructuring; Sleep hygiene; Time management; Interpersonal avoidance exposures; Physical exercise; Mindfulness; Relaxation strategies; Maintenance planning. Modules get released week-by-week, and participants are self-guided through content. To facilitate skills practice, every module is accompanied by: a weekly intro email and reminder emails; an extras section for tips/suggestions; and a weekly prize drawing. The Dashboard section of the intervention displays user progress, including self-rating graphs and a history log of skills practice. The Campus section of this dashboard provided: campus-specific announcements; referrals to relevant campus wellness resources; and an anonymous livestream of all campus users' activity."
15741768|NCT04927832|Other|SUDOSCAN and EMG (electromyogram)|The participants are evaluated clinically by a neurologist with evaluation by DN4 questionnaire, treatments and comorbidities (alcohol consumption, diabetes, etc.). They undergo from exploration by SUDOSCAN according to the already established methodology and an EMG
15741769|NCT04927819|Device|BTI Implant|BTI Dental implants are non-active medical device, single use, non resterilizable, biocompatible and sterile devices made of alloplastic materials (Titanium) intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g. bridge, single-tooth, overdenture).
15741770|NCT04927806|Device|Silver Knight|"Silver Knight breathing systems are all validated for up to seven days use, and remain active, in unopened packaging, for up to five years. Silver Knight is proven to help reduce the incidence of MRSA infection and other organisms including:
~Staphyloccus epidermis
~Pseudomonas aeruginosa
~Klebsiella pneumoniae
~Acinetobacter calcoaceticus
~Escherichia coli"
15741771|NCT04927793|Drug|EDP-938|[14C]EDP-938
15741777|NCT04927767|Device|denture adhesive|Denture adhesive is a commercially available denture care product used to adhere a denture to the oral mucosa, in order to improve the retention and stability.
15741778|NCT04927754|Behavioral|Behavioral guidance|Conventional behavior guidance technique was used in one of the different treatment sessions with intervals of two weeks for both groups, and the cartoon-assisted distraction technique was used in the other. As a result, the effect of the cartoon-assisted distraction technique during dental treatment on behavior in pediatric patients was evaluated.
15741779|NCT04927754|Other|Pain assessment|Conventional behavior guidance technique was used in one of the different treatment sessions with intervals of two weeks for both groups, and the cartoon-assisted distraction technique was used in the other. It was assessed the effect of the cartoon-assisted audio/visual distraction technique usage on paediatric patient's pain during dental care.
15741846|NCT04927156|Device|BALT medical devices|"Includes, but is not limited to, the following:
~Access devices
~Aneurysm treatment devices
~Ischemic Stroke and peripheral occlusive diseases treatment devices
~Arterio-Venous Malformations/fistulas treatment devices"
15741780|NCT04927754|Other|Dental anxiety assessment|Conventional behavior guidance technique was used in one of the different treatment sessions with intervals of two weeks for both groups, and the cartoon-assisted distraction technique was used in the other. It was evaluated the effect of the cartoon-assisted audio/visual distraction technique usage on paediatric patient's dental anxiety during treatment sessions.
15741781|NCT04927741|Other|Sweet Marjoram Essential Oil|"Subjects will receive a dilution of sweet marjoram essential oil (15 cc of grapeseed oil with 10 drops of sweet marjoram essential oil).
~Oil will be applied topically by the study medical providers. Providers will wear exam gloves, dip three fingers into the oil solution and apply it topically to the subject's lower abdomen. This will be applied by going left to right for 20 seconds while applying gentle pressure - counter pressure may be applied on the uterus to help relieve cramping."
15741782|NCT04927741|Other|Grapeseed Oil|"Subjects will receive 15 cc of undiluted grapeseed oil.
~Oil will be applied topically by the study medical providers. Providers will wear exam gloves, dip three fingers into the oil solution and apply it topically to the subject's lower abdomen. This will be applied by going left to right for 20 seconds while applying gentle pressure - counter pressure may be applied on the uterus to help relieve cramping."
15741783|NCT04927728|Other|Mental Practice|MP is the cognitive rehearsal of a motor task without physical movement, with the intent to improve motor performance. Mental practice can be completed via audio or video recording, visual prompts, written instructions, self-initiated or recorded pictures.
15741784|NCT04927728|Other|Repetitive-Task Practice|Repetitive-Task Practice is the repetitive rehearsal of a motor task with the intent to improve motor performance.
15741785|NCT04927728|Other|Traditional Therapy|Traditional therapy includes traditional interventions completed in occupational therapy for patients following a stroke. These interventions include but are not limited to, range of motion, weight-bearing, massage, modalities, self-care training, and transfer training.
15741786|NCT04927702|Device|Synthetic Hybrid-Scale Fiber Matrix|A synthetic absorbable skin substitute indicated for use in the local management of wounds. It is made of small synthetic fibers that are designed to be similar to the structure of human skin.
15741787|NCT04927702|Device|Lyophilized Acellular Fish Skin|An absorbable skin substitute comprised of intact North Atlantic Cod fish skin indicated for use in the local management of wounds.
15741788|NCT04927702|Device|Living Cellular Skin Substitute|An absorbable skin substitute comprised of human and bovine (cow) tissues indicated for use in the local management of wounds.
15741789|NCT04927676|Diagnostic Test|Blood sample|Blood samples were taken from a peripheral vein as part of clinical routine. Subsequently, a hormone status is determined.
15741790|NCT04927663|Procedure|Computed Tomography|Undergo CT imaging
15741791|NCT04927663|Procedure|Magnetic Resonance Imaging|Undergo MRI
15741792|NCT04927663|Procedure|Positron Emission Tomography|Undergo PET imaging
15741793|NCT04927663|Drug|11C-YJH08|Given IV
15741794|NCT04927650|Diagnostic Test|HPV testing|Undergo collection of cervical samples for HPV testing
15741795|NCT04927650|Other|Questionnaire Administration|Complete questionnaires
15741796|NCT04927637|Procedure|imaging 24 hours following intravenous administration of ICG|Patients will be administered a single, FDA approved, ICG, 2.5-5mg/kg dose 24 hours prior to surgery. ICG fluorescence images will be acquired By a FDA approved surgical imaging device prior to surgical debridement. The wound will be irrigated as per standard procedure and another ICG fluorescence image will be acquired. The need for repeat debridement or tissue cultures will be left up to the treating surgeon.
15741797|NCT04927624|Procedure|transversus abdominis plane block|The transversus abdominis plane (TAP) block was first introduced by Rafi et al. in 2001 as a landmark-guided technique via the triangle of Petit to achieve a field block. It involves the injection of a local anesthetic solution into a plane between the internal oblique muscle and transversus abdominis muscle. Since the thoracolumbar nerves originating from the T6 to L1 spinal roots run into this plane and supply sensory nerves to the anterolateral abdominal wall , the local anesthetic spread in this plane can block the neural afferents and provide analgesia to the anterolateral abdominal wall.
15741798|NCT04927624|Procedure|quoadratus lumborum block|quoadratus lumborum block
15741799|NCT04927611|Procedure|Biopsy, open or laparoscopic surgery|Collect NEN and PDAC biopsy or surgical fresh tissue to conduct single cell sequencing or model construction.
15741800|NCT04927598|Device|plasmapheresis|patients of Gullian Barrie syndrome undergo plasmapharesis
15741801|NCT04927585|Biological|env (A,B,C,A/E)/gag (C) DNA Vaccine|Administered by intramuscular injection in the deltoid
15741802|NCT04927585|Biological|gp120 (A,B,C,A/E) Protein Vaccine|Administered by intramuscular injection in the deltoid
15741803|NCT04927585|Biological|GLA-SE adjuvant|Administered by intramuscular injection in the deltoid.
15741804|NCT04927585|Biological|Placebo|Sodium Chloride for Injection, USP 0.9%; Administered by intramuscular injection in the deltoid.
15741807|NCT04927559|Other|Survey Administration|Complete survey
15741808|NCT04927546|Behavioral|Exercise|Thirty minutes of aerobic exercise in a treadmill.
15741809|NCT04927533|Other|Ronnie Gardiner Method|"The Ronnie Gardiner Method (RGM), developed in 1993 by Swedish jazz drummer Ronnie Gardiner, is a promising multimodal, music-based intervention with potential to stimulate and improve several cognitive functions, motor skills, reading and speech skills and social interaction. RGM participants are required to follow (what is known as) choreoscores. This is a visual representation of the sequence of movements using four unique symbols. Each symbol represents a body half via color (red = left side, blue = right side) and the use of a body part via shape (the symbols resemble hands or feet). In addition, each movement has a specific name, based on drum sounds, which must be pronounced simultaneously. The exercises are guided by trained 'RGM-practitioners'. The course and difficulty of the session can be adapted in different ways by the RGM Practitioner, according to the capabilities of the participants."
15741810|NCT04927507|Behavioral|Internet plus nursing home rehabilitation|"The observation group was given the Internet plus nursing home rehabilitation mode.
~Relying on mobile app and wechat public service platform, patients can get online guidance of rehabilitation training video through app and wechat, and get professional rehabilitation guidance at any time."
15741878|NCT04926870|Other|traditional|Clinical experience administration during teaching without PACS
15741811|NCT04927494|Behavioral|Health is Wealth: A Cervical Health Program|Health is Wealth: A Cervical Health Program will be introduced in a one-time 2-hour educational session, participants will be given HPV self-sampling kits, and instructional sheet that visually depicts the steps for self-sampling. The program will be culturally tailored to increase self-efficacy and knowledge while simultaneously addressing perceived health beliefs associated with cervical cancer and barriers associated with cervical cancer screening and HPV self-sampling. Content will be delivered in a group format (about 10-15 participants) by lecture, demonstration, and interactive exercises.
15741812|NCT04927481|Drug|Mitoxantrone Hydrochloride Liposome Injection|Mitoxantrone Hydrochloride Liposome 20 mg/m2, IV, on day 1 of each 21-day cycle (q3w).
15741813|NCT04927468|Procedure|supramaximal rectus recession|inferior rectus recession is 10mm，medial rectus recession is 9mm,superior rectus recession is 14mm for large-angle strabismus
15741814|NCT04927468|Procedure|normal rectus recession|inferior rectus recession is 7mm，medial rectus recession is 7mm,superior rectus recession is 7mm for large-angle strabismus
15741816|NCT04927390|Drug|Mycophenolate Mofetil 500mg|Mycophenolate Mofetil oral tablet twice daily for up to 96 weeks
15741819|NCT04927364|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|Intermittent theta burst (iTBS) over the left dorsolateral prefrontal cortex for 10 consecutive business days twice per day.
15741820|NCT04927364|Behavioral|Dialectical Behavioral Therapy (DBT)|Six hour-long Dialectical Behavioral Therapy (DBT) sessions with a licensed clinical psychologist, delivered over 2-3 weeks.
15741821|NCT04927351|Behavioral|Electronic Medical Record Based Discharge Medication Order Set|New medication discharge order set including recommended opioid quantities, adjunct pain medication
15741822|NCT04927338|Drug|BACOPA|The product BacoMind® will be used to provide 300 mg/day of Bacopa monnieri standardized extract.
15741823|NCT04927338|Drug|Placebo|Matching placebo bid
15741824|NCT04927325|Other|Set of Photos|A standardized set of photos will be taken with a tablet camera, SLR, thermal camera.
15741827|NCT04927299|Drug|Losartan/Chlorthalidone in fixed dose|1 tablet, once a day of 50 mg/12.5 or 100 mg/ 25 mg
15741828|NCT04927299|Drug|Losartan + hydrochlorothiazide in fixed dose|1 tablet, once a day of 50 mg/12.5 or 100 mg/ 25 mg
15741829|NCT04927286|Behavioral|Learning to Breathe|Learning to Breathe is an evidence-based mindfulness curriculum for adolescents
15741830|NCT04927286|Behavioral|Campus Connections|Campus Connections is a mentoring program for at-risk adolescents
15741831|NCT04927273|Other|Survey|Surveyed neurological and orthopedic surgeons
15741832|NCT04927260|Drug|Patient treated by Avapritinib in real life|"The patients included are treated with Avapritinib as part of their care. There is no change in treatment associated with this study.
~Patients must regularly complete various questionnaires: FACT-G, FACT-COG, and a neuropsychiatrist or a trained physician will give them the MoCA."
15741833|NCT04927247|Drug|Inclacumab|Inclacumab will be supplied in single use 10 mL vials at a concentration of 50 mg/mL. One vial contains 500 mg of inclacumab. This is a liquid concentrate for IV infusion.
15741834|NCT04927247|Drug|Placebo|Placebo will be supplied in single use 10 mL vials containing the same ingredients without the active drug. Placebo will be prepared as a liquid concentrate for IV infusion and administered in the same manner as active study drug.
15741835|NCT04927234|Device|geko™ therapy|Neuro-muscular electrical stimulation of the peroneal nerve
15741836|NCT04927221|Drug|DC371739 Tablets|Participants received one of 5 dose levels of DC371739 administered as single oral doses.
15741837|NCT04927221|Drug|Placebo|Placebo orally administered as comparison
15741838|NCT04927208|Other|exercise and nutritional support|"resistance exercise and protein supplementation including branched chain amino acids for 12 weeks
~Other: Combined exercise and nutrition intervention resistance exercise and nutritional supplementation for 12 weeks"
15741839|NCT04927195|Drug|EDP1867|EDP1867 is an orally administered, pharmaceutical preparation of a single strain of bacteria
15741840|NCT04927195|Drug|Placebo|Placebo oral capsule
15741844|NCT04927169|Drug|Interleukin-7|IM administration at 10μg/kg twice a week for three weeks and up to 7 administrations according to Hospital length of stay
15741845|NCT04927169|Drug|PLACEBO|IM administration of a volume of saline identical to 10μg/kg CYT107, twice a week for three weeks and up to 7 administrations according to Hospital length of stay
15767407|NCT04716894|Drug|BI 474121|BI 474121 oral solution
15741847|NCT04927143|Behavioral|App-Based Contingency Management|Participants will receive financial incentives for submitting randomly generated drug-negative saliva tests across the intervention period.
15741848|NCT04927143|Behavioral|Sham Control|Participants get access to the DynamiCare app but will not be provided with financial incentives.
15741849|NCT04927130|Diagnostic Test|ARNA Breast|A specific DNA fragments and globulins will be detected in blood plasma.
15741850|NCT04927104|Device|PEEK Knee Prosthesis|After subjects drop out of the study for any reason, the researchers can perform revision surgery using the prosthetic joint that is now routinely used.
15741851|NCT04927091|Other|Integration of HIV and PWID services|Co-location of clinical services for HIV and PWID patients
15741852|NCT04927078|Other|Observation of breathing pattern|Observations will be collected using a remote vision based patient monitoring and management system.
15741853|NCT04927065|Biological|mRNA-1273.211|Sterile liquid for injection
15741854|NCT04927065|Biological|mRNA-1273|Sterile liquid for injection
15741855|NCT04927065|Biological|mRNA-1273.617.2|Sterile liquid for injection
15741856|NCT04927052|Device|Revanesse Shape + with Lidocaine|Revanesse Shape + with Lidocaine. Participants had 1 cheek treated with Revanesse Shape + with Lidocaine
15741857|NCT04927052|Device|Juvederm Voluma with Lidocaine.|Juvederm Voluma with Lidocaine. Participants had 1 cheek treated with Juvederm Voluma with Lidocaine
15741858|NCT04927039|Drug|5ml of inhaled normal saline|After the initiation of OLV, 5ml of normal saline is inhaled for 20 minutes using ultrasonic nebulizer, which is connected to the inspiratory limb of the ventilator system. Arterial blood gas analysis is performed 20 minutes after the completion of drug inhalation.
15741859|NCT04927039|Drug|20μg (2ml) of inhaled iloprost (Ventavis®) and 3ml of inhaled normal saline|After the initiation of OLV, mixture of iloprost 2ml and normal saline 3ml is inhaled for 20 minutes using ultrasonic nebulizer, which is connected to the inspiratory limb of the ventilator system. Arterial blood gas analysis is performed 20 minutes after the completion of drug inhalation.
15741860|NCT04927026|Behavioral|Where-there-is-no-psychiatrist Integrated Personal Therapy (WIPT)|The WIPT include weekly face-to-face group sessions including mindfulness-based training and solution focused brief therapy (SFBT) involving psychoeducation and structured life review therapy catered to the personal needs of the participants.
15741861|NCT04927013|Behavioral|Message-based Outreach Intervention for Survivors|The Georgia Cancer Registry will mail the initial recruitment containing messages intended to persuade the survivor to visit the study website as well as a unique login to access the website. In addition to the components of the standard website, an expanded website for the Message-based group will include Guidance for Talking with Close Relatives about Their Cancer Risk, and the request to enumerate each close relative and choose from a menu of options about how the survivor would prefer for their relatives to be contacted. Survivors also can select the option that they prefer a relative not be contacted. In this case, no invitation letter will be generated for these relatives. Survivors who provide mobile phone numbers will receive two SMS thanking them for accessing the website, and encouraging them to revisit the website to review information and contact relatives. The messages will occur at 3-week intervals over a 6-week time period.
15741862|NCT04927013|Behavioral|Standard Outreach for Survivors|The Georgia Cancer Registry will mail survivors an introductory letter modeled on the Registry's general outreach letters that will include log-in information. Survivors will have access to a condensed version of the website that includes Information about Ovarian Cancer, Information about Who in Your Family is at Increased Risk, and the offer of Free Genetic Counseling with the option to schedule an appointment.
15741863|NCT04927013|Behavioral|Message-based Outreach Intervention for Close Relatives|Relatives will receive a unique website login linked to the survivor that enables access to the website. The website content will be identical to the survivor content with the exception of the addition of the Breast Cancer Genetics Referral Screening Tool (B-RST) risk assessment tool. This brief risk assessment is a validated screening tools that is clinically useful for estimating the probability of breast cancer (BRCA1/2) gene mutation and identifying women for referral to genetic counseling. Although all 1st or 2nd degree relatives of ovarian cancer survivors will screen positive on B-RST, asking relatives to complete the screener aims to raise their awareness of the factors that contribute to hereditary risk of ovarian cancer and will reinforce the salience of seeking genetic counseling. Additionally, relatives for who provide cell phone numbers will receive 3 SMS reminders over 9 weeks.
15741864|NCT04927013|Behavioral|Standard Outreach for Close Relatives|The invitation letter shared by the survivor will provide a unique login code for each relative to visit the standard website with sections specifically for relatives that include information about genetic risk, the value of completing an online short validated risk screener, and the offer of free genetic counseling with the option to schedule an appointment.
15741865|NCT04927000|Drug|Tofacitinib|in tofacitinib treatment group，we added tofacitinib 5mg/BID in the basic treatment in all subjects.
15741866|NCT04926987|Other|brain tissue single-cell sequencing|Using single-cell sequencing to study the brain tissue single-cell transcriptome difference in aging, epilepsy, and mental disorders
15741867|NCT04926974|Behavioral|Low Vision Rehabilitation|Smart phone App
15741868|NCT04926961|Device|Sham transcranial magnetic stimulation (TMS)|Sham TMS will be applied using the MagVenture MagPro X100 stimulator with the placebo side of the Cool-B65 A/P coil.
15741869|NCT04926961|Device|Real transcranial magnetic stimulation (TMS)|Real TMS will be applied using the MagVenture MagPro X100 stimulator with the active side of the Cool-B65 A/P coil.
15741870|NCT04926948|Other|Immunotherapy|Immunotherapy
15741871|NCT04926948|Other|Quality-of-Life Assessment|Ancillary studies
15741872|NCT04926948|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15741873|NCT04926935|Diagnostic Test|Microbiological analysis of blood samples.|Microbiological analysis of blood samples collected from the patients with clinically suspected infection.
15741874|NCT04926896|Procedure|Traditional iliac crest bone harvesting surgery|The experimental group and the control group do not have special requirements; perform the surgery according to the normal operation methods of different sites.
15741875|NCT04926896|Procedure|Minimally invasive bone harvesting surgery|Minimally invasive bone harvesting surgery
15741876|NCT04926883|Other|bulk-fill composite resin restorations|bulk-fill composite resin restorations up to 5mm layer thickness
15741877|NCT04926870|Other|picture archiving and communication system|PACS administration during teaching
15741883|NCT04926831|Drug|capmatinib|150 mg and 200 mg tablets for oral administration
15741890|NCT04926805|Device|CPAP with Mask A|CPAP mask
15741891|NCT04926805|Device|CPAP with Mask B|CPAP mask
15741892|NCT04926792|Device|Leadless Pacemaker|Leadless pacemaker implantation
15741893|NCT04926779|Diagnostic Test|Biozek Covid-19 Antigen Rapid Test (Saliva)|Self-collection of nasopharyngeal and saliva samples and self test performance - Biozek Covid-19 Antigen Rapid Test (Saliva) and Biozek Covid-19 Antigen Rapid Test (Nasopharyngeal Swab). Both procedures are supervised by trained study personnel.
15741894|NCT04926766|Radiation|External Beam radiotherapy using IMRT technique|2600cGy/ 5 fractions / 1 weeks to ipsilateral whole breast and a sequential tumor bed boost of 5.2 Gy in 2 fractions at the discretion of radiation oncologist
15741895|NCT04926753|Drug|5-Fluorouracil, Cisplatin, Toripalimab|Drug: FP combined with Toripalimab Combination drugs: 5-Fluorouracil(F), Cisplatin/Carboplatin(P) and Toripalimab every 21 days for 2 cycles This is a single-arm study with all patients receiving these three drugs.
15741896|NCT04926740|Other|Ringer's lactate|Ringer's lactate is the most commonly used balanced crystalloid. Compared to normal saline, balanced crystalloids have chloride concentrations similar to human plasma; therefore, treatment with balanced crystalloids may lead to faster DKA resolution.
15741897|NCT04926727|Other|Survey|Observational study
15741898|NCT04926701|Drug|ETD001 single dose|Single ascending doses of inhaled ETD001
15741899|NCT04926701|Drug|Placebo single dose|Single doses of inhaled placebo
15741900|NCT04926701|Drug|ETD001 multiple doses|Multiple ascending doses of inhaled ETD001
15741901|NCT04926701|Drug|Placebo multiple doses|Multiple doses of inhaled placebo
15741902|NCT04926675|Behavioral|Psychological Therapy|Participants will be receiving their one-to-one psychological therapy from IAPT as usual. They typically receive between 6 and 12 sessions with a psychological practitioner.
15741903|NCT04926675|Behavioral|Debt Advice|Participants will receive one-to-one support from a Citizen's Advice (CA) money advisor for as long as needed to resolve any money worries currently affecting their mental health.
15741904|NCT04926649|Procedure|Differential ventilation to the non-dependent lung|When the hypoxemia occurs during sing lung ventilation in robot-assisted cardiac surgery, the non-dependent lung will be ventilated with normal tidal volume in conventional ways and the surgery procedure have to be ceased. In this trial, the non-dependent lung will be ventilated with the continuous positive airway pressure (CPAP) or the high-frequency low-volume ventilation (HFLVV) to prevent the hypoxemia.
15741905|NCT04926636|Behavioral|Health and Wellness Coaching|An enhanced mobile application that allows for participation in health coaching features. Participants will be assigned to a health coach and will have coaching sessions scheduled.
15741906|NCT04926623|Other|CGM with Standard Education|CGM with Standard Education
15741907|NCT04926610|Other|proactive clinical ethics consultation|When the patients meet the initiation criteria of this study, the patients were randomly assigned to the intervention group (providing proactive clinical ethics consultation) and the routine care group (no proactive clinical ethics consultation) after obtaining the consent of the subjects.
15741908|NCT04926597|Dietary Supplement|nutritional supplement|daily use of one or more specific oral nutritional supplement with high energy/protein content (i.e., Resource Ultra, Resource 2.0 (Fibre), Resource Ultra Fruit).
15741909|NCT04926597|Other|individualized nutritional guidelines|nutritional plan supervised by an experienced study dietician based on the usual home nutrition with possibility to increase intake by adaptation to patient preferences, between meal snaking and food enrichment/fortification. Every 2-4 weeks phone call by unblinded study dietician to follow nutritional intervention.
15741910|NCT04926597|Other|general nutritional information|general information about health food behavior upon hospital discharge
15741911|NCT04926584|Drug|induction therapy|induction immuno-chemotherapy or immunotherapy prior to resection or definitive chemoradiotherapy
15741912|NCT04926571|Drug|Dexamethasone Oral|New users of Dexamethasone
15741913|NCT04926545|Drug|Xiao Chai Hu Tang (XCHT)|"XCHT 9g, po qd, 3 days before each cycle of chemotherapy for 5 days, except the 1st cycle of chemotherapy for irinotecan used cohort patients.
~Additional XCHT, 9g qd will be orally administrated for 4 days during the Round 0 study for irinotecan naive cohort patients."
15741914|NCT04926545|Other|Raloxifene|Raloxifene 60mg po, used as probe for pharmacokinetic testing. For irinotecan naive cohort patients, raloxifene 60mg will be orally administrated on Day 1 and Day 5 (4th day of XCHT administration) during round 0 study, Day 3 (the day before chemotherapy) during round 2 and round 3 study. For irinotecan used cohort patients, raloxifene 60mg will be orally administrated on Day 1 (irinotecan using day) during round 1 study, Day 4 (irinotecan using day) during round 2 study, and Day 3 (the day before chemotherapy) during round 3 study.
15741915|NCT04926545|Drug|FOLFIRI regimen|Patients will receive 3 cycles of FOLFIRI regimen for chemotherapy. Irinotecan intravenous (IV) infusion (180 mg/m2) through a drip into the bloodstream over 90 minutes. Folinic acid (400 mg/m2) IV infusion through a drip into the bloodstream over 2 hours. 5-fluorouracil (5-FU) IV bolus (400 mg/m2) into the bloodstream over 5 minutes, followed by 5-FU (2400 mg/m2) continuous IV infusion through a drip or pump into the bloodstream for 46-48 hours.
15741916|NCT04926532|Drug|Toripalimab|Toripalimab is a humanized anti-PD-1 monoclonal antibody
15741917|NCT04926532|Drug|Sorafenib|Sorafenib is a multi-kinase inhibitor
15741952|NCT04926181|Biological|Cetrelimab|480 mg given through intravenous infusion (IV) on day 1 of every 28-day treatment cycle and administered over a 60-minute infusion
15741918|NCT04926519|Other|Type of periodontal treatment|Identify factors that contribute to disease recurrence due to periodontal classification and periodontal treatment. One group have got the diagnosis aggressive periodontitis at baseline and the other group chronic periodontitis. Since 2018 we have the classification system with stage and grade.
15741919|NCT04926506|Drug|Xiyanping injection|Intramuscular injection of Xiyanping injection, 0.3mL / (kg.d) daily, Bid
15741920|NCT04926493|Biological|microbiological characterization|microbiological characterization of endotracheal tube biofilm
15741921|NCT04926480|Procedure|low and high flow Anesthesia|comparison of hemodynamic changes in low and high flow anesthesia groups
15741922|NCT04926467|Drug|Anakinra|"Pre-operative treatment: Nab-paclitaxel (125 mg/m2), gemcitabine (1000 mg/m2), and cisplatin (25 mg/m2) will be given on Day 1 and 8 of a 21-day cycle. Patients will receive anakinra 100 mg injection twice a day starting on day 1 of chemotherapy. Anakinra will be self-administered by the patients and will be discontinued 2 days prior to surgery. Total number of cycles = 4.
~Post-operative treatment: 5-Fluorouracil (2400 mg/m2 CI for 48 hours), oxaliplatin (85 mg/m2), and irinotecan (150 mg/m2) will be given once every 2 weeks (1 cycle =14 days). Patients will receive anakinra 100 mg injection subcutaneously twice a day starting on day 1 of chemotherapy (initiated within 4-8 weeks after surgery). Anakinra will be self-administered by the patient throughout the treatment without any break. Total number of cycles = 8."
15741923|NCT04926454|Drug|Dexmedetomidine|"Patients will be monitored using standard monitoring (heart rate, non-invasive blood pressure, ECG and pulse oximetery) After the child is adequately anesthetized, intra-venous access with appropriate size cannula will be obtained Appropriate size LMA (2 and 2.5) will be inserted and patients will be allowed to breathe spontaneously.
~patients will receive 0.25% Bupivacaine (0.3ml/Kg) with 1 μg/kg dexmedetomidine After general anaesthesia"
15741924|NCT04926441|Diagnostic Test|Stress Levels and Mental Well-Being assessment|At the beginning of the summer semester of the 2020/2021 academic year, stress levels as well as symptoms of anxiety and depression were assessed in students at four universities.
15741925|NCT04926428|Drug|tPA|Selectively catheter thrombolysis with alteplase in each main pulmonary
15741928|NCT04926402|Other|Kangaroo Care Education Program|It is a special method of caring for a premature infant in which the baby is positioned for at least 1 hour a day in an upright skin-to-skin and chest-to-chest contact with its mother.
15741929|NCT04926389|Other|low-level laser therapy applied on days 0, 3,7,14 & every 2 weeks|one side of the maxillary arch will randomly receive LLLT on days 0, 3, 7, 14, and every 2 weeks thereafter and the contralateral side will serve as the controls.
15741930|NCT04926389|Other|low-level laser therapy applied every 3 weeks|one side will also be randomly chosen to receive LLLT every 3 weeks and the contralateral side will serve as the controls.
15741931|NCT04926350|Behavioral|Resistance Exercise|8 total resistance exercises that target all major muscle groups
15741932|NCT04926337|Device|Tight Fitting Facemask|Preoxygenation with tight facemask, 10 L/min, 100% oxygen.
15741933|NCT04926337|Device|High Flow Nasal Oxygen (HFNO)|Preoxygenation with high flow nasal oxygen, 40-70 L/min, 100% oxygen.
15741934|NCT04926324|Drug|Niraparib|Niraparib is a drug FDA-approved for use in maintenance treatment of adults with advanced ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.
15741935|NCT04926324|Drug|Dostarlimab|Dostarlimab, sold under the brand name Jemperli, is a monoclonal antibody medication used for the treatment of endometrial cancer.
15741936|NCT04926324|Radiation|Short course radiation|Participants will be treated with intensity modulated radiation therapy (IMRT) or volumetric modulated arc therapy (VMAT) to minimize mean dose to femoral, pelvic, and lumbar bone marrow. The entire mesorectum will be treated to a total dose of 25 Gy.
15741937|NCT04926285|Drug|Omacetaxine|Escalating doses of Omacetaxine 0.625 mg/m2 q12h, 1.25 mg/m2 q12h, 2.0 mg/m2 q12h, and 2.5 mg/m2 q12h
15741938|NCT04926285|Drug|Venetoclax|Venetoclax at 400mg
15741939|NCT04926272|Drug|18F-92|Intravenous injection of one dose of 0.10mCi/kg(±5%) 18F-92. Each subject receive a single intravenous injection of 18F-92, and undergo PET/CT imaging within the specificed time.
15741940|NCT04926259|Drug|18F-T807|Intravenous injection of one dose of 10mCi (370MBq, ±5%) 18F-T807. Each subject receive a single intravenous injection of 18F-T807, and undergo PET/CT imaging within the specificed time.
15741941|NCT04926246|Drug|BI 685509 oral formulation prototypes|BI 685509
15741942|NCT04926246|Drug|BI 685509 standard oral formulation|BI 685509
15741943|NCT04926233|Drug|Tiotropium bromide + Olodaterol|Tiotropium bromide + Olodaterol
15741944|NCT04926233|Device|Sp(t)iolto® Respimat®|Sp(t)iolto® Respimat®
15741948|NCT04926207|Behavioral|Physical Activity Breaks Intervention|Participants will be asked to walk on a treadmill for 3 min at a moderate intensity (55% of heart rate reserve) at an increasing speed and incline to reach and maintain their target heart rate.
15741949|NCT04926207|Behavioral|Talking Breaks Control|Every 30 min a researcher will start a brief conversation with a participant based on a pre-selected topic, which will change with each break. Topics are standardized across participants and include, for example, pollution, smart clothes, and hydration. A presentation will be followed by questions and answers. The break will last 3 min.
15741950|NCT04926194|Biological|Decidual stromal cells (DSC)|DSCs are isolated from donated human placenta and have been shown to have anti-inflammatory effects.
15741953|NCT04926168|Other|Delay of TMZ|Delay of TMZ to analyze the current standard of care practice of prescribing TMZ post combination (RT and TMZ).
15741954|NCT04926168|Other|Standard of Care (SOC) Adjuvant TMZ (no intervention|SOC in Adjuvant Setting no intervention
15741955|NCT04926155|Drug|Metformin|The starting daily dose of metformin is 500mg once daily, and add a dose of 500mg per week until the target dose of 2000mg once daily if tolerated. Metformin will be continued until disease progression.
15741956|NCT04926142|Device|Implantation of Holter device|Implantation of a Holter device (Reveal Linq, Medtronic) for telemonitoring of cardiac rhythm
15741957|NCT04926142|Procedure|Percutaneous PFO closure|Patients will undergo percutaneous closure of patent foramen ovale
15741958|NCT04926129|Other|Other: Assessments|Administered as specified in the treatment arm.
15741959|NCT04926116|Drug|AK3280|Active Substance: AK3280, Pharmaceutical Form: Tablet, Route of Administration: Oral
15741960|NCT04926116|Drug|Placebo|Active Substance: Placebo, Pharmaceutical Form: Tablet, Route of Administration: Oral
15741961|NCT04926103|Other|Fecal Microbiota transplant (FMT)|Patients will come once a week for FMT for 8 weeks. FMT is the administration of the supernatant component of stool and water mixture from a healthy relative or an unrelated donor. The donor's stool and blood is rigorously screened to exclude known communicable diseases. Those that achieve remission with FMT will have the option of continuing FMT once per month for 3 years
15741962|NCT04926090|Behavioral|Emotional Support Plan - Clinician Guided (ESP-C)|The Emotional Support Plan (ESP) is designed to help prepare students to cope with stress experienced during postsecondary education. The ESP-C is delivered by a clinician in 2 sessions.
15741963|NCT04926090|Behavioral|Emotional Support Plan - Self Guided (ESP-S)|The Emotional Support Plan (ESP) is designed to help prepare students to cope with stress experienced during postsecondary education. The ESP-S is created by the participant on their own, with the support of self-guided materials.
15741965|NCT04926051|Drug|BMS-986172|Specified dose on specified days
15741966|NCT04926051|Other|Placebo|Specified dose on specified days
15741967|NCT04925986|Drug|Sitravatinib|Groups 1A and 2A receive Sitravatinib 100mg orally (PO) daily starting on cycle 1 day 1 (C1D1). Groups 1B and 2B) receive Sitravatinib 100mg orally (PO) daily starting on Cycle 2 Day 1 (C2D1).
15741968|NCT04925986|Drug|Pembrolizumab|All groups (1A, 1B, 2A, 2B) receive Pembrolizumab 200mg intravenous every three weeks (IV Q3w) on cycle 1 day 1 (C1D1).
15741969|NCT04925973|Drug|Tofacitinib 10 MG [Xeljanz]|Tofacitinib 10mg PO BID
15741970|NCT04925960|Drug|Epalrestat|Epalrestat is a noncompetitive and reversible aldose reductase inhibitor (ARI) used for the treatment of diabetic neuropathy in Japan. The drug's ability to safely improve symptoms of neuropathy alone by reducing oxidative stress, increasing glutathione levels, and reducing intracellular sorbitol accumulation make it a desirable medication for PMM2-CDG patients who commonly suffer with various neuropathies. However, work recently conducted by Perlara, a public benefit company with the mandate to screen existing commercially available drugs for possible application in rare diseases, has demonstrated that Epalrestat can also elevate the level PMM2 produced endogenously. This may reduce the severity of the morbidities associated with PMM2-CDG.
15741971|NCT04925947|Drug|KN046|KN046 will be given intravenously at 5 mg/kg every 2 weeks. A cycle is defined as 2 treatments (28 days). Treatment will be given until progression, excessive toxicity, or up to two years.
15741972|NCT04925934|Drug|VIB7734|VIB7734
15741973|NCT04925934|Other|Placebo|Placebo
15741974|NCT04925921|Device|SR-1 Laser|3-4 treatments at 4-6 week intervals
15741975|NCT04925908|Diagnostic Test|RT-PCR for SARS-Cov-2|Nasopharyngeal swab for detecting Novel Coronavirus-2 by reverse transcriptase polymerase chain reaction
15741976|NCT04925895|Other|Dynamic soft tissue mobilization|Dynamic soft tissue mobilization will be given in the following sequence, In supine position with 90˚ flexion of knee and hip joint deep longitudinal strokes will be applied from distal to proximal direction along with the tightened area of hamstring while passively stretching the hamstring. Total 5 longitudinal strokes will be applied followed by shaking for 20 seconds. Then progressed to the next dynamic technique in the above-mentioned sequence but the patient will be asked to do leg extension actively to achieve reciprocal inhibition of the hamstring muscle. In The next step, the subject will apply a force to the therapist's hand to engage the hamstring eccentrically as the muscle will be lengthened to its end range. In that position, the therapist will apply 5 deep longitudinal strokes from the distal towards the proximal direction on tight hamstring muscles.
15741977|NCT04925895|Other|Proprioceptive neuromuscular facilitation stretching|The position of the patient will be supine lying with 90⁰ flexion of hip. Therapist will passively extend the knee joint where patient will feel a mild stretch. Then therapist will ask the patient to do knee flexion in counter resistance applied by the therapist by using about 50% of his maximum strength and isometric contraction of hamstring muscles will be achieved. Patient will maintain that isometric contraction for 8 seconds then relax on therapist command. Just after relaxation therapist will further stretch the hamstring muscle to the point of mild to moderate painless stretch and patient will hold it for 30 seconds. Three repetitions will be applied in each session.
15741978|NCT04925895|Other|Cryotherapy|application of cold pack on knee joint for 10 minutes
15741979|NCT04925895|Other|Isometric knee strengthening excercises|"i. Isometric hip adductors exercises in crook lying: Two sets of 10 repetitions with a 10-seconds hold will be carried out.
~ii. Isometric quadriceps strengthening exercises in supine lying: A towel roll underneath the knee joint will be used to perform this exercise. Two sets of 10 repetitions with a 10-seconds hold will be performed."
15741980|NCT04925882|Procedure|Erector spinae plane block|"After installing the sleeping patient and identifying the surgical level by the surgeon, the anesthetist will perform the erector spinae plane block. The anesthetist performs an ultrasound to view the spine and erector muscles and identifies the transverse processes of the vertebra involved in the surgery. Once the location has been made, the anesthetist injects the anesthetic product under ultrasound control between the erector muscle of the spine and its anterior fascia, the trajectory of the needle being thus visualized throughout the procedure. The anesthetist bilaterally injects 3ml/kg of solution with a maximum of 30ml injected.
~Drug : Levobupivacaïne 2,5mg/ml."
15741981|NCT04925882|Procedure|Erector spinae plane block|"After installing the sleeping patient and identifying the surgical level by the surgeon, the anesthetist will perform the erector spinae plane block. The anesthetist performs an ultrasound to view the spine and erector muscles and identifies the transverse processes of the vertebra involved in the surgery. Once the location has been made, the anesthetist injects the anesthetic product under ultrasound control between the erector muscle of the spine and its anterior fascia, the trajectory of the needle being thus visualized throughout the procedure. The anesthetist bilaterally injects 3ml/kg of solution with a maximum of 30ml injected.
~Drug : NaCL 0,9%."
15741982|NCT04925869|Other|Observational study|Observational study
15741983|NCT04925856|Other|blood sample|"•Blood sample:
~1 heparinized tube (4 mL) for collection of plasma and storage
~1 heparinized tube (4 mL) for immunophenotyping,
~4 EDTA tubes (4 x 10 mL) for collecting white blood cells (PBMC) for cryopreservation."
15741985|NCT04925817|Other|Electronic Health Record Review|Medical record reviewed
15741986|NCT04925817|Procedure|Ultrasound Microvessel Imaging|Undergo 3D ultrasound microvessel imaging
15741987|NCT04925791|Diagnostic Test|standardized pre-conditioning treatment|3 rounds of 5 minutes of full occlusion alternating with 5 minutes of reperfusion while seated.
15741988|NCT04925791|Diagnostic Test|Partial occlusion|3 rounds of 5 minutes of partial occlusion alternating with 5 minutes of reperfusion while seated.
15741989|NCT04925778|Drug|monomethyl fumarate|Patients will be prescribed 190 mg (two 95 mg capsules) self-administered twice/day,
15741990|NCT04925765|Device|Flowly (TMC-CP01)|The Flowly (TMC-CP01) treatment utilizes virtual reality and biofeedback to train patients to auto-regulate themselves and improve their pain/anxiety/depression.
15741991|NCT04925752|Drug|Oral Lenacapavir (LEN)|Tablets administered orally without regard to food
15741992|NCT04925752|Drug|F/TDF|Tablets administered orally
15741993|NCT04925752|Drug|Sub-cutaneous (SC) Lenacapavir (LEN)|Administered via SC injections
15741994|NCT04925752|Drug|Placebo SC LEN|Administered via SC injections
15741995|NCT04925752|Drug|PTM F/TDF|Tablets administered orally
15741996|NCT04925752|Drug|PTM Oral LEN|Tablets administered orally
15741997|NCT04925739|Other|Self-questionnaire on the comfort and general appreciation of a nasal mask|Self-questionnaire on the comfort and general appreciation of a nasal mask after 30 days of use
15741998|NCT04925739|Other|Self-questionnaire on the appearance of CPAP side effects related to the mask|Self-questionnaire on the appearance of CPAP side effects related to the mask (air leaks, injury to the nasal bridge, etc.) after 30 days of use
15741999|NCT04925739|Other|Self-questionnaire on the patient's appreciation of the mask headgear,|Self-questionnaire NOSE on the patient's appreciation of the mask headgear, which includes indications to help with the installation in the form of graduated markers, as well as the appreciation of the general aesthetics of the mask, after 30 days of use.
15742000|NCT04925739|Other|Self-questionnaire NOSE on the discomfort caused by the nasal obstruction|Self-questionnaire NOSE on the discomfort caused by the nasal obstruction reported by the patient, after 30 days of use, compared to the inclusion.
15742001|NCT04925739|Other|Self-questionnaire Epworth on the daytime sleepiness|"Self-questionnaire Epworth on the daytime sleepiness of the patient, after 30 days of treatment, compared to the inclusion.
~To study the parameters of the CPAP treatment."
15742002|NCT04925739|Other|To study the CPAP compliance|To collect the treatment compliance through telemonitoring of the data recorded by the CPAP machine, during the 30 days of treatment.
15742003|NCT04925739|Other|To study the unintentional leakage|To collect the unintentional leakage estimated by the CPAP machine, during the 30 days of treatment.
15742004|NCT04925739|Other|To study the therapeutic pressures of CPAP|To collect the therapeutic pressures of CPAP, during the 30 days of treatment.
15742005|NCT04925726|Other|Land based exercise|The patients who had land based exercise
15742006|NCT04925726|Other|Water based exercise|The patients who had water based exercise
15742007|NCT04925713|Biological|IFx-Hu2.0|"The investigational drug product IFx-Hu2.0 is composed of the drug substance pAc/emm55 (pDNA) complexed with the two excipients in vivo-jetPEI® (linear polyethylenimine), a transfection reagent, and dextrose, a pDNA/polyethylenimine complex stabilizer.
~Therapeutic Classification:
~Immunomodulatory Agent
~Route of Administration:
~Intralesional (i.e. injection of cutaneous, subcutaneous or lymph nodal lesions)
~Mechanism of Action:
~Injection of IFx-Hu2.0 into the lesion facilitates the expression of the immunogenic Emm55 protein by the tumor cells.
~Physiological Effect:
~Expression of the emm55 gene by the tumor cells triggers immune recognition of tumor-specific and -associated antigens which leads to innate and adaptive immune responses."
15742008|NCT04925700|Dietary Supplement|ProDentis Lozenge|1-2 ProDentis Lozenges per day
15742009|NCT04925700|Other|Placebo Lozenge|1-2 Placebo Lozenges per day
15742010|NCT04925687|Biological|Intravitreal autologous CD34+ cells|Autologous CD34+ cells harvested from bone marrow injected intravitreal
15742011|NCT04925674|Drug|HEC53856|"The 100mg dose cohort in the hemodialysis: D1 single oral administration of the investigation product 2.5h before hemodialysis; Three times a week for 6 weeks starting from D8, oral administration of the test drug 2.5h after hemodialysis.
~The rest dose cohorts in the hemodialysis: Three times a week for 6 weeks starting from D1, oral administration of the investigation product 2.5h after hemodialysis.
~The dose cohort in the peritoneal dialysis: Three times a week for 6 weeks starting from D1, oral administration of the investigation product after fasting."
15742012|NCT04925661|Drug|HEC53856|Either dose of HEC53856 will be administered after fasting .
15742013|NCT04925661|Drug|Roxadustat|Roxadustat will be administered after fasting .
15742014|NCT04925661|Drug|Placebo|Either dose of placebo will be administered after fasting .
15742074|NCT04925167|Drug|Argatroban|Argatroban continuous intravenous injection maintained APTT at 1.5 times of baseline.
15767408|NCT04716894|Drug|Itraconazole|Itraconazole oral solution
15742017|NCT04925635|Behavioral|experimental group|"The arteriovenous fistula care mobile health application will be installed and promoted on the smart phones of the patients in the experimental group. Arteriovenous fistula care mobile health application will be installed in daytime groups during working hours during or at the end of dialysis according to the patient's request. In addition, the information contained in the arteriovenous care mobile health application will be verbally explained to the patients and their relatives, as well as shown in practice. The training results were evaluated by the researcher in the 1st and 3rd months in the Scale for Evaluation of Self-Care Behaviors Related to Arteriovenous Fistula in Hemodialysis Patients, Final Level of Renal Failure Compliance Scale, Arteriovenous Fistula Care Education Knowledge Level Evaluation Form (Post-Training Section) and  Visual Benchmarking Scale ."
15742018|NCT04925635|Behavioral|control group|"Patients in the control group will receive arteriovenous fistula care training and a training booklet will be given. The information contained in the booklet will be explained orally to the patients and their relatives by the researcher, and will also be shown in practice. The results of the training were determined by the researcher at the 1st and 3rd months of the Self-Care Behaviors Scale for Arteriovenous Fistula in Hemodialysis Patients, End Stage Renal Failure Compliance Scale, Arteriovenous Fistula Care Training Information Level Assessment Form (Post-training section) and Visual It will be evaluated with the Comparison Scale."
15742020|NCT04925609|Drug|Brigatinib|Brigatinib is a second generation novel, orally administered, tyrosine kinase inhibitor (TKI) that potently inhibits activated variants of ALK and to a lesser extent ROS1.
15742021|NCT04925596|Behavioral|ePrimaPrescribe online educational program|online training program aiming to change general practitioners' benzodiazepine prescription
15742022|NCT04925596|Behavioral|ComunicaSaudeMental online educational program|online training program aiming to improve general practitioners' communication with mentally ill patients
15742023|NCT04925583|Radiation|Stereotactic body radiotherapy (SBRT)|"level 0 (de-escalation): 10 x 5.0Gy
~level 1 (start): 10 x 5.5Gy
~level 2: 10 x 6.0Gy
~level 3: 10 x 6.5Gy"
15742024|NCT04925570|Device|W-SUDs|Woebot (W-SUDs) is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.
15742025|NCT04925570|Other|Education Only|The education only control intervention is a form of psychoeducation for those seeking treatment for their alcohol and/or substance use concern. Psychoeducation is commonly provided for those with substance use. Psychoeducation in substance use is intended to increase the users' knowledge of their substances of use, and effects on the body, behaviors, and consequences. The recipient of psychoeducation is expected to increase their own awareness of their substance use and ideally incorporate this newfound knowledge when making changes to their substance use. The information provided in this group are from factsheets found on NIAAA, NIDA, and CDC web pages.
15742026|NCT04925557|Drug|Mayzent|PET imaging to evaluate the effects of Mayzent on the microglia of the brain.
15742027|NCT04925557|Drug|Ocrevus|PET imaging to evaluate the effects of Ocrevus on the microglia of the brain.
15742028|NCT04925544|Drug|VK-2019|VK-2019 binds to EBNA1 and inhibits EBNA1 DNA binding activity. VK-2019 API is synthesized by Anthem BioSciences Pvt. Ltd and formulated into capsules by Emerson Resources Inc,
15742029|NCT04925531|Drug|Antibiotics|to examine if either the utility of antibiotics administered for 3 days or 5 days make a difference in the clinical outcomes after facial fractures in trauma patients.
15742030|NCT04925518|Device|Closed Loop Mechanical Ventilation|Closed loop ventilation mode (Intellivent-ASV+®). Intellivent-ASV+® was initiated by activating the controllers for minute volume, PEEP (range 5 to 18 cmH2O) and fraction of inspired oxygen (FiO2) (range 21 to 100 %). The target shift ranges for CO2-management were set between -2.5 and +2.5 kPa, and for O2-management between -2 and +2 %.
15742031|NCT04925518|Device|Conventional Mechanical Ventilation|Mechanical ventilation with a conventional mode, usually either biphasic positive airway pressure ventilation (DuoPAP®) or adaptive support ventilation (ASV®)
15742032|NCT04925505|Procedure|Interscalene brachial plexus blocks with ultrasound guidance under general anesthesia|Ultrasound-guidance, interscalene brachial plexus blocks, in-plane technique, perineural injection, 0.5% ropivacaine 12.5ml and 0.2% lidocaine 12.5ml
15742033|NCT04925492|Radiation|Positron Emission Tomography|An imaging method that uses radiotracers to view changes in the metabolic process.
15742034|NCT04925492|Drug|Cu-64]-LLP2A|A radioactive tracer used in PET imaging.
15742035|NCT04925479|Drug|Asciminib Pediatric formulation group|"Asciminib Pediatric formulation group: Mini-tablets will be supplied as size 0 capsules containing 1 mg mini-tablets, taken orally:
~10 mg (10x 1 mg tablets in capsule) BID 15 mg (15x 1 mg tablets in capsule) 20 mg (20x 1 mg tablets in capsule) BID 30 mg (30x 1 mg tablets in capsule) BID"
15742036|NCT04925479|Drug|Asciminib Adult formulation group|"Asciminib Adult formulation group:
~40 mg tablets BID, taken orally. 20 mg tablets BID, taken orally."
15742037|NCT04925466|Device|CPAP at pressure of 10 cmH2O|Patients used CPAP with the pressure of 10 cmH2O during overnight polysomnography
15742038|NCT04925466|Device|CPAP at minimal effective pressure|Patients with OSA will be treated with CPAP at minimal effective pressure derived from manual titration during sleep.
15742039|NCT04925453|Combination Product|active tDCS and cognitive training intervention|Intervention sessions will occur during Visits 2-6. Cognitive training will occur concurrently with tDCS in both the active and sham tDCS groups. Over each 46-minute daily training period, 4 of 5 BrainHQ training tasks will be performed for approximately 11 minutes in a randomly selected order. Order of task presentation will be randomized each session. Stimulation sequences will occur in the first 13 minutes (shut off: Minute 13) of the session and the last 13 minutes of the session (turn on: Minute 33). The Symptom Rating Questionnaire (SRQ) will be asked before and after stimulation to assess for any side-effects. The BrainHQ Task Load Index (TLX) will be administered at the end of each intervention session. At the end of Intervention Session 3, subjects will be given a Blinding Questionnaire which asks whether they thought they received active or sham treatment.
15742040|NCT04925453|Combination Product|sham tDCS and cognitive training intervention|Intervention sessions will occur during Visits 2-6. Cognitive training will occur concurrently with tDCS in both the active and sham tDCS groups. Over each 46-minute daily training period, 4 of 5 BrainHQ training tasks will be performed for approximately 11 minutes in a randomly selected order. Order of task presentation will be randomized each session. Stimulation sequences will occur in the first and last 13 minutes of the session. For sham stimulation, the electrodes will be placed at the same positions as for active stimulation, but current will be ramped down immediately after the initial 30s ramp up period. The Symptom Rating Questionnaire (SRQ) will be asked before and after stimulation to assess for any side-effects. The BrainHQ Task Load Index (TLX) will be administered at the end of each intervention session. At the end of Intervention Session 3, subjects will be given a Blinding Questionnaire which asks whether they thought they received active or sham treatment.
15742041|NCT04925440|Dietary Supplement|Bifidobacterium longum 1714® strain|Probiotic capsules containing 5 x 10^9 CFUs, corn-starch and magnesium stearate.
15742042|NCT04925440|Dietary Supplement|Placebo|Capsules containing corn-starch and magnesium stearate only.
15742043|NCT04925427|Behavioral|Case Management and Peer Recovery|A blend between a Critical Time Intervention (CTI) case management model and a peer recovery coaching approach. CORI will employ peer-based case management/recovery coaching and other transitional services (e.g., peer navigation) to provide support and service linkages to medication-assisted treatment (MAT) and harm reduction interventions to reduce subsequent opioid use and related harms.
15742044|NCT04925427|Behavioral|Naloxone-Only|Participants will be trained on naloxone administration, and upon re-entry, they will be given a naloxone kit and information on local resources for harm reduction, SUD treatment, and additional supportive services.
15742045|NCT04925414|Drug|oxygenotherapy|High concentration mask delivering 15L/min of oxygen
15742046|NCT04925414|Drug|placebo air aerosol|High concentration mask delivering 15L/min of air
15742047|NCT04925401|Behavioral|The Information brochure will be created on the basis of information given by the French pediatric network Courlygone and the French National Authority for Health.|An information brochure on fever in children and how to deal with a paediatric febrile episode and usual medical management.
15742048|NCT04925388|Other|rapid molecular diagnosis|peritoneal samples will be analysed using Unyvero IAI test
15742049|NCT04925388|Other|conventional method analysis|peritoneal samples will be analysed using conventional method
15742050|NCT04925375|Drug|Abatacept|Abatacept is a selective costimulation modulator, inhibiting T lymphocyte activation by binding to CD80 and CD86, thereby blocking interaction with CD28. Orencia solution supplied in a prefilled syringe should be refrigerated at 2C to 8C (36F to 46F). Orencia should not be used beyond the expiration date on the prefilled syringe. The product should be protected from light by storing in the original package until time of use. The prefilled syringe should not be frozen.
15742051|NCT04925375|Other|Placebo|The composition of the placebo for Orencia is the same as the active study drug without the abatacept. The placebo will be packaged and labeled as described above for the Orencia prefilled syringes. To maintain the blind, injection volumes will be the same as the active treatment.
15742052|NCT04925362|Other|Biological specimens|"Biological specimens are collected to better characterize patients of different severity and improve our understanding of clinical and histological heterogeneity at diagnosis :
~added for the research : blood, urine, stools
~collected for the research : liver tissue sample, if a liver biopsy is indicated for clinical reasons (standard of care)"
15742053|NCT04925362|Other|Additional visit|Visits if possible during standard care, otherwise added by the research (If necessary the annual visit will be added by research for the collection of biological samples)
15742054|NCT04925349|Diagnostic Test|Blood sample collection|blood sample collection
15742055|NCT04925336|Other|Nociceptive stimulation|"These investigations in healthy volunteers will study the association between cerebral and neurovegetative (sympathetic and parasympathetic) electrophysiological responses in response to a controlled and tolerable pain stimulus, determined for each individual. The pain stimulus will be delivered using an electrically conductive glove used in clinical practice for transcutaneous therapeutic stimulation.
~The thresholds of nociception and tolerance will be determined in each healthy volunteer."
15742056|NCT04925323|Biological|BLOOD SAMPLES|BLOOD SAMPLES
15742057|NCT04925323|Biological|surgical tissue samples|unused surgical tissue removed during plastic surgeries
15742058|NCT04925297|Other|No intervention|No intervention will be given
15742059|NCT04925284|Drug|XB002|IV administration of XB002
15742060|NCT04925271|Device|X-Tack|The mucosal or submucosal defect is closed with X-Tack.
15742061|NCT04925271|Device|Overstitch|The mucosal or submucosal defect is closed with Overstitch.
15742062|NCT04925258|Behavioral|SPACE Parenting Program|The program involves a two-arm randomized trial of differing parenting interventions which include: a service as usual (SAU) cohort, in which parents are provided with local and online parenting and family mental health resources; An intervention group called SPACE that includes weekly parenting materials (i.e., two online ~10-minute videos, ten parent-child activities that were developed for the Building Regulation in Dual Generations (BRIDGE) Therapy program (NCT04347707 and NCT04639557) intervention group. Additionally, this group will receive weekly drop-in sessions with a facilitator-led (trained MA-level or higher psychology student or psychologist) interactive parenting group to re-enforce concepts and provide social support.
15742063|NCT04925245|Other|Clinical Reminder|Clinical reminder in the electronic medical record
15742064|NCT04925232|Device|Transcranial Magnetic Stimulation device|Five days a week for 2 consecutive weeks, participants will have repetitive TMS at specific paramaters
15742065|NCT04925219|Behavioral|Remotely supervised exercise programme|Electronic walking log Fortnightly video/telephone calls with physiotherapist
15742066|NCT04925219|Behavioral|Self-directed exercise|Electronic walking log and instructions to exercise 4 times per week.
15742067|NCT04925206|Biological|ET-01|Recruited participants will receive ET-01 IV infusion following myeloablative conditioning with busulfan.
15742075|NCT04925167|Drug|unfractionated heparin|unfractionated heparin continuous intravenous injection maintained APTT at 1.5 times of baseline.
15742077|NCT04925141|Drug|Dasatinib Tablets|Tyrosine Kinase Inhibitor (TKI)
15742078|NCT04925128|Other|treadmill|Data collection procedure will be comprised of total 6 weeks, 5 days of session per week. Initially taken baseline values will be taken after every two weeks i.e 2nd , 4th and 6th.
15742079|NCT04925115|Other|Brisk walking|"Warm up and cool down (10 minutes before physical activity)
~Brisk walking ( 30 minutes each session for 5 days in a week)"
15742080|NCT04925102|Other|Standardized treatment protocol for cerebral palsy|Passive and active range of motion (ROM) exercises of all joints, prone positioning, slow prolonged manual stretching (30 minutes daily), standing frame for children with GMFCS IV-V, supported sitting, supported walking, lower limb serial casting (if needed), active strength training, progressive resistance training, functional exercises, sensory integration: therapeutic activities to organize sensation from the body and environment, bimanual training: repetitive task training in the use of two hands together, context-focused therapy: changing the task or the environment, the occupational therapy, cognitive behaviour therapy and home programmes.
15742081|NCT04925089|Other|Blood and Tissue collection|Blood and tissue will be collected and analyzed for detection of ctDNA
15742082|NCT04925076|Drug|Ethanol|A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
15742083|NCT04925076|Other|Placebo|A beverage that does not meaningfully increase breath alcohol concentration.
15742084|NCT04925063|Drug|Metformin|The starting daily dose of metformin is 500mg once daily, and add a dose of 500mg per week until the target dose of 2000mg once daily if tolerated. Metformin will be continued until disease progression.
15742085|NCT04925050|Drug|VB0004|Each study part (A,B and C) will be completed sequentially or with partial overlapping. Safety and PK data through at least day 8 from a subsequent cohort will be reviewed by the SMC prior to dosing the fed period of FE cohort. Safety data will be assessed by SMC after completing each cohorts in MAD healthy volunteers and MAD mild Hypertension patients.
15742086|NCT04925050|Other|Matching Placebo for VB0004|Matching Placebo
15742087|NCT04925037|Behavioral|self-questionnaire to patients undergoing SpAax follow-up|On the occasion of a single visit in consultation or hospitalization, an anonymous self-questionnaire will be distributed to patients undergoing SpAax follow-up
15742089|NCT04925011|Drug|Roxadustat|Starting doses of 20, 50, 70 or 100 mg/30,70,90,or 120mg based on weight and dialysis or not.
15742090|NCT04924998|Drug|current treatment of AL-CM|current treatment of AL-CM
15742091|NCT04924985|Other|Non-Physiological Feedback CPR|Non-physiologically guided CPR using AV feedback (integrated into defibrillators)
15742092|NCT04924985|Other|Physiological Feedback CPR|Physiological feedback CPR using an optimal regional O2 Saturation (rSO2), End-tidal CO2 (ETCO2) or combined (rSO2/ETCO2) target
15742093|NCT04924972|Procedure|Blepharoplasty|90 patients undergoing bilateral upper eyelid blepharoplasty are randomly assigned to a suturing technique (running cutaneous or subcuticular Nylon (6-0 Prolene) sutures). Steri-strips will be used until suture removal 7 days after blepharoplasty for patient blinding.
15742094|NCT04924959|Other|Logistic Regression Analysis|Using logistic regression analysis to analyze the independent risk factors of PICC catheter displacement
15742095|NCT04924946|Other|Inventory of prescribing habits and detect any differences in efficacy and tolerance of antihypertensive drugs|"Time to monitor blood pressure values in target targets
~Need for administration of another antihypertensive drug
~Disappearance of organ failure attributable to hypertension
~Weaning from an extra-renal purification
~Weaning from mechanical ventilation
~Improved kidney function
~Iatrogenic hypotension
~Need for suspension of treatment
~Other side effect"
15742096|NCT04924933|Diagnostic Test|Computerised associative memory task using abstract words and landscape photographs|Two test sessions using the computerised associative memory task will be performed by the two groups (patients and control subjects). The first session will consist of the encoding of 56 associations between a word and a photograph and the recall of half of them (28) 30 minutes later by the mean of a matching task and a recognition task. The second session consists of the recall of the other half of the associations (28) 72 hours after the encoding phase, using the same procedure (matching task and recognition task). Performance obtained by patients and by healthy volunteers will then be compared.
15742097|NCT04924920|Diagnostic Test|SIGH|To add the Sigh35 to PSV, the ventilator is set in pressure controlled synchronized intermittent mandatory ventilation plus PSV [SIMV (PC) + PS mode], with SIMV rate set a 1/min and inspiratory time of 4 seconds. SIMV (PC) = 35 cmH20 of total inspiratory support (PEEP + PS).
15742098|NCT04924920|Diagnostic Test|EEOT|• The EEOT is performed by interrupting the mechanical ventilation for 15 seconds, by using and end-expiratory hold on the ventilator. The ventilator trigger is set at 2 L/min.
15742099|NCT04924894|Other|no intervention|no intervention
15742100|NCT04924881|Drug|COVID Rehab Formula granules|COVID Rehab Formula granules once daily for 8 weeks
15742101|NCT04924881|Other|Placebo granules|Placebo granules once daily for 8 weeks
15742102|NCT04924868|Drug|Ursodeoxycholic Acid|Ursodeoxycholic Acid will be administered to patients in the UDCA group as a prophylactic measure of future complications associated to gallstones
15742103|NCT04924868|Drug|Placebo|Placebo: composition per 100g: colloidal silica 1.95g and cellulose microcrystalline 98.05g.
15742104|NCT04924855|Other|Blood sampling (4 per year)|Blood sampling (4 per year)
15742105|NCT04924842|Other|Review of medical file|Review of medical patient file, including patient tracing, brief summary of the disease course, barrier gestures, social distancing.
15742106|NCT04924842|Other|Phone call interview|less than 15 minutes phone call
15767471|NCT04716335|Drug|Placebo (DMT)|Placebo for DMT (intranasal)
15742107|NCT04924829|Drug|Tocilizumab|Tocilizumab received as a single intravenous infusion over the period of 60 minutes. Dose of 8 mg/kg, maximum dose of 800 mg.
15742108|NCT04924816|Procedure|Awake prone position|The prone position in awake patients consists of asking the patient to voluntarily change to prone position, in a swimmer's posture
15742109|NCT04924803|Behavioral|No video|Weekly text messages
15742110|NCT04924803|Behavioral|Video Text|Weekly text messages including links to intervention videos
15742111|NCT04924790|Behavioral|COVID-19 Pandemic|Comparison of the intervention preferences of patients diagnosed with obstructive urinary stones in the urology clinic and recommended for intervention during and before COVID-19
15742112|NCT04924777|Other|Brisk Walk|1-Brisk walk for 30 minutes 2-5 days a week 3-3months
15742113|NCT04924777|Other|Strength training|1-Strength Training Exercises for 30 minutes. 2-5 days a week 3-3 months
15742114|NCT04924777|Other|Aerobic Exercises|1-Aerobic exercises for 30 minutes 2-5 Days a week 3-3months
15742115|NCT04924764|Other|Conventional physical therapy.|Conventionally used intervention for subacute and chronic neck pain.
15742116|NCT04924751|Diagnostic Test|Endoscopic ultrasound-guided fine needle biopsy|Under endoscopic ultrasound guidance, fine-needle biopsy is used to collect biopsy samples from solid pancreatic lesions throughout the digestive tract and is useful in diagnosing solid pancreatic lesions.
15742117|NCT04924738|Behavioral|Monitoring and lifestyle|Dietary and lifestyle modification recommended for pregnant women with hyperglycemia detected in pregnancy.
15742118|NCT04924725|Procedure|Endoscopic ultrasound-guided fine needle biopsy|Endoscopic ultrasound-guided fine-needle biopsy is used to collect biopsy samples from solid pancreatic lesions throughout the digestive tract and is useful in diagnosing solid pancreatic lesions
15742119|NCT04924712|Other|Measurement of blood immune populations and microbiota distribution.|Measurement of peripheral cell populations by spectral cytometry and in parallel, sequencing of intestinal and urinary bacterial 16S RNA of each patient.
15742120|NCT04924699|Drug|MRG002|Administrated intravenously
15742121|NCT04924686|Other|Observational studies, no intervention|Observational studies, no intervention
15742122|NCT04924660|Drug|TXA127|TXA127 0.5 mg/kg/day infused 3 hours daily for 5 days or until hospital discharge whichever comes first.
15742123|NCT04924660|Drug|TRV027|TRV027 12mg/h as a continuous 24-hour infusion, infused for 5 days or until hospital discharge whichever comes first.
15742124|NCT04924660|Drug|Placebo|NaCl 0.9% infused to match the duration of the agent (3 hours for TXA127 and continuous 24-hour infusion for TRV027
15742125|NCT04924647|Drug|lenalidomide and dexamethasone|lenalidomide 25mg d1-21 and dexamethasone 20-40mg d1，8，15，22
15742126|NCT04924634|Diagnostic Test|Stress Levels and Mental Well-Being assessment|At the beginning of the summer semester of the 2020/2021 academic year, stress levels as well as symptoms of anxiety and depression were assessed in students at four universities.
15742127|NCT04924621|Device|Respiratory Humidification Treatment Device, AIRVO 2 PT101AZ, Fisher & Paykel Healthcare, Inc.|"Patients in group T were given sequential intravenous infusion with THRIVE device: midazolam 0.05mg/kg, sufentanil 0.02-0.05ug/kg, propofol 2-3ug/ml, rocuronium 0.06mg/kg, to make BIS < 60 .
~The nasal cavity was disinfected with Iodophor cotton swab, and the appropriate nasal cavity was selected for endotracheal intubation assisted by fiberoptic bronchoscope according to the experience of anesthesiologists.
~After the endotracheal intubation was fixed, the anesthesia machine was connected for mechanical ventilation. The anesthesia machine was set at 50% oxygen +50% air, and the tidal volume was set at 6-8ml/kg."
15742128|NCT04924621|Device|Mask ventilation|The Control Group will receive sequential intravenous infusion of Sufentanil 5ug, midazolam 0.05mg/kg, and propofol 1-2ug/ml, to make the BIS between 70 and 80. 2ml tetracaine was injected with cyclothyroid membrane puncture, and the nasal cavity was disinfected with iodophor cotton swab. According to the experience of anesthesiologists, the appropriate nasal cavity was selected for intranasal endotracheal intubation assisted by fiberbronchoscope. After the endotracheal intubation was successful, the anesthesia machine was connected for mechanical ventilation, full narcotic inducer will be injected. The anesthesia machine was set at 50% oxygen +50% air, and the tidal volume was set at 6-8ml/kg.
15742129|NCT04924608|Drug|Selumetinib|Selumetinib oral capsules (10 mg and 25 mg)
15742130|NCT04924608|Other|Placebo|Placebo oral capsules for Selumetinib masking (10 mg and 25 mg)
15742131|NCT04924595|Behavioral|Personalised exercise|Personalised exercise intervention including aerobic and resistance training
15742132|NCT04924582|Other|Capacity Coaching|Capacity Coaching focuses on developing the capacity within patients to adapt, endure, and function optimally in their lives along with illness and treatment.
15742133|NCT04924569|Device|Intermittent Catheter|Flexible tubular device used to drain urine from the bladder via the urethra by male, female, and pediatrics.
15742134|NCT04924543|Other|Online self-learning training module|Training module in optical diagnosis of IBD-associated dysplastic lesions during gastrointestinal endoscopy
15742135|NCT04924543|Other|Refresher training|Brief refresher training in optical diagnosis of IBD-associated dysplastic lesions during gastrointestinal endoscopy
15742136|NCT04924530|Dietary Supplement|Maltodextrin|Co-ingestion of maltodextrin with a high fat meal
15742137|NCT04924530|Dietary Supplement|Sucrose|Co-ingestion of sucrose with a high fat meal
15742138|NCT04924530|Dietary Supplement|Lactose|Co-ingestion of lactose with a high fat meal
15742139|NCT04924517|Behavioral|Extended Evening Fasting|Participants will undertake 4 days of extended evening fasting (feeding between 8am-4pm). The participants will visit the laboratory on day 1, following a 16 h fast, where baseline measures will be taken and the response to a standardised meal will take place. The participant will also have an opportunity to feed ad-libitum before they leave the laboratory. The participant will continue to adhere to the feeding window on day 2 and day 3, although this will be in free-living conditions. On day 4, the participant will arrive back to the lab for post-intervention assessment, identical in format to day 1 with a metabolic assessment and energy intake assessment via a ad-libitum meal.
15742223|NCT04923932|Drug|Savolitinib|Patients meeting the study inclusion criteria will receive Savolitinib [Savolitinib 600 mg, po, once per day (QD) continuously in patients with baseline weight ≥50 kg, and Savolitinib 400 mg, po, QD in patients with baseline weight <50 kg] in 21 day treatment cycle, until disease progression, death, intolerable toxicity or other termination criteria as specified in the protocol, whichever occurs earliest.
15742140|NCT04924517|Behavioral|Control|Participants will undertake 4 days of a standard western feeding pattern (feeding between 8am-8pm). The participants will visit the laboratory on day 1, following a 12 h fast, where baseline measures will be taken and the response to a standardised meal will take place. The participant will also have an opportunity to feed ad-libitum before they leave the laboratory. The participant will continue to adhere to the feeding window on day 2 and day 3, although this will be in free-living conditions. On day 4, the participant will arrive back to the lab for post-intervention assessment, identical in format to day 1 with a metabolic assessment and energy intake assessment via a ad-libitum meal.
15742141|NCT04924504|Other|No interventions|No interventions
15742142|NCT04924491|Biological|Autologous thyTreg|Treg lymphocytic cells, differentiated, autologous, of thymic tissue, expanded and stimulated with Interleukin (IL-) 2 (thyTreg)
15742143|NCT04924478|Biological|Mepolizumab|Patients will be receiving this treatment as part of their standard clinical care
15742144|NCT04924465|Other|Follow-up|Follow-up of clinical data, laboratory tests, radiological data and pulmonary function tests
15742145|NCT04924452|Procedure|Laser conditioning and Sealant application|Sealant application protocol includes: a low-speed rubber cup and pumice paste (CleanPolish, Kerr) will be used for 30 seconds for cleaning and polishing of the occlusal surface of the chosen permanent molar; tooth surface will be washed for debris and organic residue removal and dried with air spray; isolation; laser conditioning of the occlusal enamel surface. The parameter settings used will be: tip-to-tissue distance 1.5mm from the tooth surface; tip diameter 600 µm; laser energy 70 mJ; pulse frequency 10 Hz; water spray level 8; average power 0.7 W; energy density 67 J/cm2; tooth surface will be etched with 35% phosphoric acid gel (Etching gel, DMP Ltd) for 30 seconds and rinsed for the same time; reisolation; tooth surface will be dried with air spray for 15s; fissure sealant application (Pit&Fissure Sealant, DMP Ltd); light cured for 20 seconds.
15742146|NCT04924452|Procedure|Sealant application|Sealant application protocol includes: a low-speed rubber cup and pumice paste (CleanPolish, Kerr) will be used for 30 seconds for cleaning and polishing of the occlusal surface of the chosen permanent molar; tooth surface will be washed for debris and organic residue removal and dried with air spray; isolation; tooth surface will be etched with 35% phosphoric acid gel (Etching gel, DMP Ltd) for 30 seconds and rinsed for the same time; reisolation; tooth surface will be dried with air spray for 15s; fissure sealant application (Pit&Fissure Sealant, DMP Ltd); light cured for 20 seconds.
15742147|NCT04924452|Device|Er:YAG laser therapy|Er:YAG laser (LiteTouch, Light Instruments LTD), emission wavelength 2940 nm will be used for caries removal - parameters: enamel removal - energy 100-200mJ; density 9.84-13.03 J/cm2, pulse frequency 20Hz; tip diameter 800 μm; water spray level 8; tip-to-tissue distance 0.5÷1 mm form the tooth surface; dentin removal - energy 100mJ; density 9.84 J/cm2, pulse frequency 20Hz; tip diameter 800 μm; water spray level 8; tip-to-tissue distance 0.5÷1 mm form the tooth surface. Restoration with compomer.
15742148|NCT04924452|Procedure|Conventional therapy|Conventional rotary instruments will be used for caries removal - high-speed and low-speed dental handpieces. Restoration with compomer.
15742149|NCT04924439|Other|foot reflexology|Foot reflexology was applied to the experimental group for 40 minutes once a week for postpartum 8 weeks. The control group was only watched.
15742150|NCT04924426|Procedure|TTC immersion|TTC immersion
15742151|NCT04924413|Drug|Tislelizumab|PD-1 positive lymphocytes are isolated from peripheral blood and amplified for transfusion
15742152|NCT04924400|Behavioral|CHIP Program|"GHP members randomized to the intervention arm will participate in the following activities:
~Attend 2 group meetings per week over 6 weeks, followed by one group meeting per week for 6 weeks (12 weeks total); each meeting will last about one hour. CHIP classes for weeks 1-4 and week 12 require in-person attendance, while week 5-11 classes can be attended either virtually or in-person.
~Receive a copy of The Optimal Diet, The Official CHIP Cookbook.
~The following data will be collected at weeks 1,12 and 26:
~Biometrics: weight, BMI, waist circumference, systolic and diastolic blood pressure
~Biomarkers (blood tests): HbA1c, LDL-C
~Psychometrics: Wellbeing360 survey"
15742153|NCT04924400|Behavioral|Usual Care|"GHP members assigned to the control arm will receive the routine standard of care for GHP members. Members will receive a summary of diabetes-related benefits available to members with type 2 diabetes.
~The following data will be collected at weeks 1,12 and 26:
~Biometrics: Weight, BMI, waist circumference, systolic and diastolic blood pressure
~Biomarkers (blood tests): HbA1c, LDL-C
~Psychometrics: Wellbeing360 survey"
15742154|NCT04924387|Procedure|Exercise|All patients will start learning how to activate the abdominal muscles in the first training session. The exercise progression will be adapted according to the capacity of each patient, considering their pain levels. The exercises will be made in 1 to 3 series of among 8 and 15 repetitions and the isometric contractions for 5 to 10 seconds. The rests between series will be of 30 seconds, and between exercises of 2-3 minutes.
15742157|NCT04924348|Procedure|Experimental: WALANT procedure|"The WALANT technique, performed under ultrasound, includes two punctures.
~The first is a puncture through a medial approach above the wrist and includes two injections. A first subcutaneous injection reproducing a bar above the wrist flexion line, and a second injection above the median nerve. The volumes injected vary from 8 to 10 milliliters (ml).
~The second puncture is performed at the base of the palmar surface of the hand and consists of a 10 ml subcutaneous injection of the local anesthetic in order to take advantage of the vasoconstrictive effects of adrenaline, thus allowing the surgical procedure to be performed without a pneumatic tourniquet."
15742158|NCT04924348|Procedure|Active Comparator: Axial ALR|The anesthetic protocol in the axillary block consists of performing a puncture, using a needle (50 mm 22G with a short bevel), under the armpit at the level of the axillary hollow after skin disinfection. This puncture, performed under ultrasound, allows the injection of the local anesthetic around the median, radial, ulnar and musculocutaneous nerves. The volume injected per nerve can vary from 5 to 8 ml depending on the visual appreciation during the injection.
15742261|NCT04923607|Drug|TQC2731|TQC2731 injection
15742159|NCT04924348|Procedure|Active Comparator: Truncal ALR|The anesthetic protocol in truncal block consists in injecting the local anesthetic around the median and ulnar nerves by a puncture performed at the elbow or forearm (depending on the practitioner's experience). The volumes injected remain the same and the puncture is also performed under ultrasound guidance. Additional local anesthesia is administered by injecting an additional 5 ml above the wrist flexion line to block the sensory territory of the musculocutaneous nerve.
15742160|NCT04924335|Procedure|Erector spinae plane block|Preoperative ultrasound-guided bilateral erector spinae plane block with 20 ml 0.025% bupivacaine.
15742161|NCT04924322|Drug|Enoxaparin|Enoxaparin is a LMWH produced from UFH that exerts its anticoagulant effects by binding to and inducing a conformational change in antithrombin to accelerate the inactivation of factor Xa and thrombin. Age-specified dose of enoxaparin will be administered within 24 hours after insertion of the CVC with the dose subsequently adjusted to pre-specified anti-Xa target.
15742162|NCT04924309|Other|Exposure: donor sperm|One group use donor sperm through the process of assisted reproduction and the other uses husband's semen.
15742163|NCT04924296|Drug|SHR-1314|SHR-1314 s.c. + Steroids
15742164|NCT04924296|Drug|Placebo|Placebo s.c. + Steroids
15742165|NCT04924283|Behavioral|Tetris and Assessments|Participants will complete assessments on their phone to rate cravings for alcohol. Participants will complete a visual cognitive interference task (i.e., play Tetris on their phone) after endorsing a alcohol craving, and then re-rerate craving after the task.
15742166|NCT04924283|Other|Assessment Only|Participants will complete assessments on their phone to rate cravings for alcohol.
15742167|NCT04924270|Biological|Faecal microbiota transplantation|The capsule FMT transplant consists of faeces obtained from a thoroughly screened, unpaid, anonymous stool donor. Each FMT product is made from 50g faeces diluted in sterile saline (0.9% NaCl) and glycerol, blended, centrifuged and filtered to remove particulate material before transfer to double-layered capsules. The FMT capsules will be stored at - 80 ⁰C until use. On the day of the FMT, the FMT capsules will be thawed to room temperature before treatment.
15742168|NCT04924270|Other|Placebo|Placebo capsules consist of NaCl (0.9%) and glycerol added brown food colouring.
15742169|NCT04924257|Drug|Esketamine nasal spray|Patients will receive two treatments per week for four weeks (maximum of eight treatment sessions) or until clinical remission (MADRS <10).
15742170|NCT04924257|Procedure|Electroconvulsive therapy|Patients will receive three treatments per week for four weeks (maximum of 12 ECT treatments) or until clinical remission (MADRS <10).
15742171|NCT04924244|Other|Music Therapy|We will play music of the subject's choice of genre during the procedure.
15742172|NCT04924244|Other|No Music|No music will be played during the subject's interventional procedure
15742173|NCT04924231|Behavioral|astigmatism|astigamatism at least 1 month after the cataract surgery
15742174|NCT04924218|Procedure|endoscopic surgical intervention|The researchers investigated whether endoscopic surgical procedures performed due to various indications (hematuria, urinary tract stone, suspected bladder mass) in the patient group who had undergone radical prostatectomy, caused a change in urinary incontinence level. The researchers divided the endoscopic instruments used into 3 groups and evaluated whether there was a difference in urinary incontinence level between rigid cystoscope, flexible cystoscope and ureterorenoscope groups.
15742175|NCT04924205|Device|FM2 Knee Brace|Participants in this group will use the FM2 Knee Brace for their post-TKA physical therapy.
15742176|NCT04924192|Drug|TQB3616 capsules|A CDK4/6 kinase inhibitor
15742177|NCT04924192|Drug|Anlotinib Hydrochloride capsules|A multi-target receptor tyrosine kinase inhibitor
15742178|NCT04924192|Drug|Irinotecan Hydrochloride for Injection|An inhibitor of DNA topoisomerase Ⅰ
15742179|NCT04924179|Drug|Tislelizumab plus Surufatinib and SBRT|Surufatinib:250mg ,qd,po,21 days for a cycle;Tislelizumab Injection:200mg，IV,d1,21 days for a cycle;SBRT:8-10Gy×5F,qod,in 10 days.
15742180|NCT04924166|Drug|Placebo|Inactive dose of capsules that appear identical to active dose
15742181|NCT04924166|Drug|Hydrocortisone|Hydrocortisone 180 mg in capsule form
15742182|NCT04924153|Other|No Intervention|Administered as specified in the treatment arm.
15742184|NCT04924127|Diagnostic Test|Detection of IDH and TERT mutation|Detection of IDH and TERT mutation using frozen glioma tissues
15742194|NCT04924088|Behavioral|Medical-legal partnership|Treatment group will receive the MLP intervention through the Connecticut Veterans Legal Center in partnership with the VA Connecticut Healthcare System. The MLP intervention can be categorized into seven activity components: initial in-person and subsequent in-person interviews; discussions with clients by phone; research and review of relevant documents; consultations with clinicians or other attorneys; interactions with opposing parties; time appearing at formal hearings; and travel time.
15742195|NCT04924088|Behavioral|Referral to pro-bono lawyer|Control group will receive outside legal aid, i.e., control participants will be referred to pro-bono lawyers in the state.
15742197|NCT04924062|Biological|Pembrolizumab|Pembrolizumab by intravenous (IV) infusion
15742198|NCT04924062|Drug|Gemcitabine|Gemcitabine by IV infusion
15742199|NCT04924062|Drug|Cisplatin|Cisplatin by IV infusion
15742200|NCT04924062|Drug|Placebo|Placebo to pembrolizumab
15742224|NCT04923919|Drug|Anti-CLL1 CART cells|In this study, patients with acute myeloid leukemia were treated with autologous anti-CLL1 CAR T cells by a single, intravenous infusion.Blood and bone marrow were collected before and 12 months after infusion to detect the number and activity of CAR T cells, and to evaluate the efficacy of CAR T cells.
15742262|NCT04923607|Drug|Placebo|Matching placebo with no active ingredients
15742201|NCT04924049|Other|Video-assisted education|Prior the study, the content and comprehensibility of the VE were evaluated by an orthopedic surgeon, two orthopedic nurses, and a physiotherapist who were not involved in the study and relevant amendments were made based on their suggestions. The preview of the final version of the VE was shown to four patients (10% of the sample) and these patients were excluded from the study. The patients were interviewed by phone calls on a weekly basis and watching VE at home, the frequency of watching VE, and doing home-based exercises were questioned.
15742202|NCT04924036|Drug|glycopyrronium cloths|Qbrexza is an anticholinergic indicated for topical treatment of axillary hyperhidrosis in adults and pediatric patients 9 years of age and older
15742203|NCT04924023|Behavioral|kaleidoscope application|The children looked into the kaleidoscope and slowly turned it. The researcher asked the children about the colours and shapes seen inside the kaleidoscope. This distraction procedure began immediately before the central venous catheter dressing and continued until it was finished.
15742204|NCT04924010|Behavioral|Cognitive Behavioural Therapy (CBT)|The CBT intervention will be delivered by a Senior Psychologist with seventeen years of hospital psychology experience, six in the treatment of chronic pain patients. Sessions are delivered in one hour, individual therapy appointments to patients, and there is an emphasis on relaxation training, cognitive restructuring, exercise and pacing, behavioral activation, improving sleep, and anger management. Standardized worksheets and homework assignments are an important part of CBT-CP and these will be given (post or email) to patients who will be asked to read and complete in terms of complementing the consultations. This intervention has been developed with reference to two sources: A successful national implementation of CBT for chronic pain (CBT-CP) using video teleconferencing format [Connolly KS et al] AND an evidence-based CBT manual specifically designed to treat chronic pain [Murphy JL et al].
15742205|NCT04924010|Behavioral|Education and Mindfulness|To control for differences in attention between the two interventions, patients in the mindfulness group will also have two meetings before the surgery and two meetings afterward. As the same person will be providing the CBT-CP and educational interventions, this confounding factor will be controlled for. The control intervention consists of discussing pain education, as derived from the self-management section of the chronic pain Ireland website (https://www.chronicpain.ie/our-services/self-management) and the persistent pain section of the pain toolkit website (https://www.paintoolkit.org/persistent-pain). Four mindfulness-based stress reduction exercises will be completed including an introductory session on mindful breathing, a guided meditation, progressive muscle relaxation, and a body scan. These sessions will last about half an hour.
15742206|NCT04923997|Behavioral|HealthScore Health Coaching|6 months of integrative health coaching, physical activity goal setting, and surveys.
15742207|NCT04923984|Procedure|Embolization of the middle meningeal artery|embolization of the middle meningeal artery with an embolic agent.
15742208|NCT04923971|Other|Purdue Pegboard|Participants will assemble the pegboard with their left, right, and both hands in each environmental condition.
15742209|NCT04923958|Diagnostic Test|FLOW-TB Next-generation LAM|A next-generation urine lipoarabinomannan (LAM) assay (Salus Discovery, Madison, USA)
15742210|NCT04923958|Diagnostic Test|TAM-TB|T-cell Activation Marker (TAM)-TB (Beckman Coulter, Brea, USA), a novel immunodiagnostic test that characterizes expression of an activation marker (CD38) and a maturation marker (CD27) on M. tuberculosis-specific CD4 (cluster of differentiation 4) T cells to discriminate active disease from latent infection or no infection
15742211|NCT04923958|Diagnostic Test|Host Response Cartridge|Xpert TB Host-Response (Cepheid, Sunnyvale, USA), a cartridge-based whole blood gene expression assay
15742212|NCT04923958|Diagnostic Test|IChroma POC CRP|iChroma POC CRP (Boditech, South Korea), a point-of-care (POC) assay for measuring C-reactive protein (CRP)
15742213|NCT04923958|Diagnostic Test|Breath sensor|A breath sensor (Bio-Rad, Hercules, USA)
15742214|NCT04923958|Diagnostic Test|Automated CXR (chest X-ray)|CAD for Good (EPCON), an open-source computer-aided diagnosis (CAD) tool for chest x-ray interpretation
15742215|NCT04923958|Diagnostic Test|Next-generation LAM|A novel urine LAM assay that seeks to optimize sensitivity without compromising specificity by increasing the affinity of anti-LAM antibodies (Mologic, Thurleigh, UK)
15742216|NCT04923958|Diagnostic Test|Oral swab Xpert Ultra|Oral swab analysis (OSA) using Xpert MTB/RIF Ultra (University of Washington, Seattle, USA and Cepheid, Sunnyvale, USA
15742217|NCT04923958|Diagnostic Test|Xpert MTB cfDNA Cartridge|"Xpert MTB cell-free DNA (Cepheid, Sunnyvale, USA), a cartridge-based assay that detects M. tuberculosis cell-free DNA (cfDNA) in the acellular fraction of plasma or urine, also known as liquid biopsy"
15742218|NCT04923958|Diagnostic Test|Nanodisk-MS2|NanoDisk-MS (mass spectrometer) uses antibody-conjugated nanoparticles to enrich serum peptides derived from M. tuberculosis proteins CFP-10 and ESAT-6. (NanoPin, Phoenix, USA)
15742219|NCT04923958|Diagnostic Test|Deeplex Myc-TB|an assay originally developed for NGS (next-generation sequencing) platforms that identifies mutations in 18 main MTB drug resistance-associated gene targets to detect resistance to 13 anti-TB drugs/drug classes including all first- and most second-line drugs (injectables, fluoroquinolones, bedaquiline, clofazimine, linezolid, and ethionamide
15742220|NCT04923958|Diagnostic Test|DeepChek-TB|An assay that identifies the established high and medium confidence drug resistance targets for isoniazid, rifampin, ethambutol, injectables, fluoroquinolones, pyrazinamide, and linezolid. (GenoScreen, France)
15742221|NCT04923958|Diagnostic Test|Nanopore-optimized targeted sequencing assay|an assay developed specifically for use with the MinION platform. It detects resistance to all first- and most second-line drugs (injectables, fluoroquinolones, ethionamide, bedaquiline, linezolid, and clofazimine). The minimal infrastructure requirements for the MinION platform make it ideally suited to generating rapid and comprehensive drug resistance profiles onsite at district-level and reference laboratories in high burden countries.(Quadram Institute and Oxford Nanopore Technologies [QI/ONT], UK)
15742222|NCT04923945|Drug|Savolitinib|Patients meeting the study inclusion criteria will receive Savolitinib [Savolitinib 600 mg, po, once per day (QD) continuously in patients with baseline weight ≥50 kg, and Savolitinib 400 mg, po, QD in patients with baseline weight <50 kg] in 21 day treatment cycle, until disease progression, death, intolerable toxicity or other termination criteria as specified in the protocol, whichever occurs earliest.
15768130|NCT04711213|Drug|Placebo Dose 2|Placebo suspension dose 2
15742225|NCT04923906|Drug|Aumolertinib|"Aumolertinib 110 mg QD in combination with pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) or carboplatin (AUC5) on Day 1 of every 21-day cycles up to 4~6 cycles, followed by Aumolertinib daily with pemetrexed maintenance (500 mg/m2) on Day 1 of every 21-day cycles.
~Dose may be reduced to allow for the management of investigational drug related toxicity."
15742226|NCT04923906|Drug|Placebo Aumolertinib|Placebo Aumolertinib 110 mg QD Dose may be reduced to allow for the management of investigational drug related toxicity.
15742227|NCT04923893|Drug|Bortezomib|Bortezomib will be administered SC.
15742228|NCT04923893|Drug|Dexamethasone|Dexamethasone will be administered orally.
15742229|NCT04923893|Drug|Lenalidomide|Lenalidomide will be administered orally.
15742230|NCT04923893|Drug|Cilta-cel|Cilta-cel infusion will be administered.
15742231|NCT04923893|Drug|Cyclophosphamide|Cyclophosphamide will be administered intravenously.
15742232|NCT04923893|Drug|Fludarabine|Fludarabine will be administered intravenously.
15742233|NCT04923880|Other|Implementation of Primary Palliative Care Intervention in CF Centers|"Individuals with CF ages 12 years and above will complete an annual palliative care needs assessment with the CF care team using the IPOS (Integrated Palliative Care Outcome Scale).
~Individuals with CF under 12 years of age will complete an annual palliative care needs assessment with the CF care team using IPOS as a conversation guide.
~Caregivers of Individuals with CF of all ages will be offered the BASC (Brief Assessment Scale for Caregivers).
~In addition to annual needs assessment, palliative care needs assessment will take place when triggered by changes in disease status, such as hospitalization, new diagnosis of CF related Diabetes or referral to transplant."
15742234|NCT04923867|Device|Suturable DuraGen™|Suturable DuraGen™ Dural Regeneration Matrix, an absorbable implant for repair of dural defects.
15742235|NCT04923854|Other|No intervention|No intervention
15742236|NCT04923841|Other|A high intensity light box and myopic defocus|In this study, the effect of bright light given by a high intensity light box and its combination with myopic defocus will be given as interventions. Myopic defocus will be delivered by Defocus Incorporated Multiple Segments (DIMS) spectacle lenses.
15742237|NCT04923815|Device|THERMOCOOL SMARTTOUCH® Diagnostic/Ablation Deflectable Tip Catheter|THERMOCOOL SMARTTOUCH® catheter is a pressure catheter irrigated with cold saline, contact force sensing catheter. When used with Carto ®3 system, this catheter can provide a real time measurement for contact force. The magnitude and direction of the contact force can be displayed visually in the form of vector arrow on the top of catheter in Carto®3 system. It can be used for electrophysiological mapping and ablation of the heart.
15742238|NCT04923776|Drug|Carboplatin|The dosage for this drug is area under the curve (AUC) 5 mg/ml/min intravenous, Day 1, every 21 days for 4 cycles. This is standard of care.
15742239|NCT04923776|Drug|Etoposide|The dosage for this drug is 100 mg/m2 Intravenous, Days 1-3, every 21 days for 4 cycles. This is standard of care.
15742240|NCT04923776|Drug|Atezolizumab|The dosage for this drug is 1200 mg Intravenous, Day 1, every 21 days until disease progression. This is standard of care.
15742241|NCT04923776|Radiation|Stereotactic Body Radiation Therapy (SBRT)|This radiotherapy is given within +/-3 days of cycle 2, 10 Gy 3 doses on alternating days. This is not standard of care and considered interventional.
15742242|NCT04923737|Drug|Dexmedetomidine|patients will receive a loading dose of IV Dexmedetomidine1μg/kg slowly just before induction of anesthesia, then Dexmedetomidine infusion started at a rate of 0.5μg/kg/h.
15742243|NCT04923737|Drug|0.9% sodium chloride|patients will receive an equal volume of 0.9% sodium chloride (both the loading, and the infusion
15742244|NCT04923724|Device|tourniquet|tourniquet is a device used during total knee surgery.
15742245|NCT04923724|Device|No tourniquet|tourniquet is a device used during total knee surgery, this group does not get one
15742246|NCT04923711|Behavioral|Moderate intensity exercise prescription|"Exercise Intensity： Low-risk patients: the lower of 60-69% reserve heart rate or the heart rate at the anaerobic threshold.
~Moderate-risk or high-risk patients: the lower of 50-59% reserve heart rate or the heart rate at the anaerobic threshold."
15742247|NCT04923711|Behavioral|High intensity exercise prescription|"Exercise Intensity： Low-risk patients: the lower of 70-85% reserve heart rate or the heart rate at the anaerobic threshold.
~Moderate-risk or high-risk patients: the lower of 60-70% reserve heart rate or the heart rate at the anaerobic threshold."
15742248|NCT04923698|Other|yoga training|All women in group B were treated by the same antidepressant drugs as in group A and yoga program, 50 minutes daily, 7 days per week for 12 weeks (Total 84 sessions).
15742249|NCT04923685|Other|Trier Social Stress Test|The TSST is a standardized test to induce acute psychological stress in humans. Participants will abstain from caffeine for 12 hours and nicotine for 2 hours prior to the test. An IV butterfly catheter will be placed in an arm vein and flushed with saline. Participants will rest for 15 minutes. A 10ml baseline blood sample will be drawn. They will perform the TSST task and then have 10ml of blood drawn at 0, 15, 30, 60, and 90 minutes post-TSST.
15742250|NCT04923672|Behavioral|Moderate continuous exercise|Participants will be asked to wear an Apple watch and use a smartphone application to help increase their activity to 5 days a week, about 40 minutes a day of continuous moderate intensity exercise prior to surgery. They will be asked to continue wearing the watch through about 30 days after surgery.
15742251|NCT04923672|Behavioral|High intensity interval exercise|Participants will be asked to wear an Apple watch and use a smartphone application to help increase their activity to 5 days a week, about 40 minutes a day of intervals of high and moderate intensity exercise prior to surgery. They will be asked to continue wearing the watch through about 30 days after surgery.
15742252|NCT04923659|Drug|Carbamazepine|600 mg reconstituted as one table. Administered once
15742253|NCT04923659|Drug|Lorazepam|2.5 mg mg reconstituted as one table. Administered once
15742254|NCT04923659|Drug|Dextromethorphan|150 mgmg reconstituted as one table. Administered once
15742255|NCT04923659|Drug|Nimodipine|30 mg reconstituted as one table. Administered once
15742256|NCT04923659|Drug|Placebo|Administered once
15742257|NCT04923646|Other|Primer|Mailed postcard notifying Veteran of upcoming FIT kit for annual CRC screening.
15742258|NCT04923633|Device|Quantifiable Soft Tissue Manipulation (QSTM)|Quantifiable soft tissue manipulation (QSTM) is a force sensing device system that can be used by a clinician to apply a massaging force while the system monitors objective metrics, i.e., the amount, rate, and angle of force applied.
15742265|NCT04923581|Behavioral|Oral Health Behavioral Interventions|The study will use a factorial design to evaluate the efficacy of three distinct intervention components: Motivational interviewing, storytelling videos and oral health promotion messages, in enhancing mothers' brushing of their preschool children's teeth using fluoridated toothpaste.
15742266|NCT04923568|Device|EaseVRx|Participants will experience 2 sessions of the EaseVRx device for chronic pain
15742267|NCT04923555|Behavioral|Vegetable proteins (VP) rich in leucine, cystein, arginine|33 volunteers will consume 400 ml of yogurt with vegetable proteins (VP) rich in leucine, cystein and arginine only once during the visit. At the beginning and the end of the intervention, exploration will be conducted at fasted state and at post-prandial state after the administration of vegetable proteins.
15742268|NCT04923555|Behavioral|Animal proteins (AP)|33 volunteers will consume 400 ml of yogurt with animal proteins (AP) rich in leucine, cystein and arginine only once during the visit. At the beginning and the end of the intervention, exploration will be conducted at fasted state and at post-prandial state after the administration of animal proteins.
15742269|NCT04923555|Behavioral|No protein (T)|33 volunteers will consume 400 ml of yogurt without any protein (T) rich in leucine, cystein and arginine only once during the visit. At the beginning and the end of the intervention, exploration will be conducted at fasted state and at post-prandial state after the administration of animal proteins.
15742273|NCT04923529|Drug|TAS 102|"Days 1 through 5: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5.
~Days 6 through 7: Recovery Days 8 through 12: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 8 of each cycle and the last dose administered in the evening of Day 12.
~Days 13 through 28: Recovery"
15742274|NCT04923516|Other|Dosage of Delta-aminolevulinic acid and Porphobilinogen|Results of dosages of Delta-aminolevulinic acid and Porphobilinogen which are performed in accordance with the current practice will be recorded
15742275|NCT04923503|Behavioral|diurnal fasting|subject conduct fasting in Ramadan for 30 days
15742276|NCT04923490|Behavioral|state and trait anxiety scale levels|"While the STAI-I anxiety level is scored as (1) never, (2) somewhat, (3) frequently, and (4) almost always, the scoring options in STAI-II are (1) almost never, (2) sometimes, (3) most of the time, and (4) almost always."
15742277|NCT04923477|Other|Therapeutic Exercise for Rotator Cuff Tendinopathy / Subacromial Pain Syndrome|Therapeutic exercise of resistance and mobility via a combination of HEP and in-person/virtual visits 5 days/ wk x 4 wks. Exercise program instruction in person, then 2-3 visits /wk x 4 wks (in-person or virtual) with a trained professional for progression of exercises. Adherence to exercise will be measured daily via text and recorded in a mobile app. Patients will start with Phase 1 exercises of shoulder external & internal rotation, scapular stabilization, and active shoulder elevation; resistance levels of elastic bands will be assigned and progressed based on patient reported shoulder pain and perceived difficulty. Patients will be progressed to Phase 2 when they complete Phase 1. The exercise protocol will be delivered with the methods previously published by Tate, 2010 and Mintken 2016.
15742278|NCT04923451|Device|Active Trans-cranial direct current stimulation (tDCS)|5 active sessions (1/day for 5 consecutive days) of tDCS (NeuroConn DC), active anode 8cm2 on right dorso-lateral prefrontal cortex and neutral cathode, 2 mA, during 30 min will be performed
15742279|NCT04923451|Device|Sham Trans-cranial direct current stimulation (tDCS)|5 placebo sessions (1/day for 5 consecutive days) of sham tDCS (NeuroConn DC), anode 8cm2 on right dorso-lateral prefrontal cortex and neutral cathode during 30min will be performed
15742280|NCT04923438|Other|Telerehabilitation|The exercise program will begin with a warm-up, followed by a stretching exercise and an alphabetical exercise game called what's your name, and will end with a cool-down. The exercises will be performed 2 times a week for a total of 12 weeks, and each program will last for roughly 30 minutes. it will last. In what is your name game, 10 5-letter words containing the whole alphabet were produced and children will work out the exercises corresponding to each letter with a word they choose for each day.
15742281|NCT04923438|Other|Control|The same exercise program will be prepared and given to the patients who are offered and not accepted telerehabilitation, and they will be asked to do their own exercises at home. This group will also be included in the study as a control group.
15742282|NCT04923412|Procedure|Pulmonary branch of vagus nerve preserved|During the mediastinal lymph node dissection using minimally invasive surgery, efforts to preserve the pulmonary branch of vagus nerve is made.
15742283|NCT04923412|Procedure|Pulmonary branch of vagus nerve not preserved|During the mediastinal lymph node dissection using minimally invasive surgery, efforts to preserve the pulmonary branch of vagus nerve is not made/ can be severed.
15742284|NCT04923386|Other|None (not interventional)|This is not an intervention
15742285|NCT04923373|Other|telerehabilitation|"Procedure for both groups:
~I pre surgery evaluation
~initial training in hospital
~physiotherapeutic programme telerehabilitation versus standard 7 times a week
~Therapy duration: 6 weeks post-surgery II 6weeks post-surgery evaluation"
15742286|NCT04923373|Procedure|standard physiotherapy|standard physiotherapy
15742287|NCT04923347|Drug|FF/UMEC/VI|FF/UMEC/VI will be administered
15742288|NCT04923347|Device|ELLIPTA|Participants will receive FF/UMEC/VI using ELLIPTA inhaler.
15742350|NCT04922788|Biological|Nanocovax|Recombinant Protein spike (s) SARS-CoV-2 and 0,5 mg Aluminum adjuvant
15742351|NCT04922788|Biological|Placebo|0,5 mg Aluminum adjuvant
15743035|NCT04916860|Biological|Senl-T7|Patients will be treated with CD7 CAR-T cells
15742289|NCT04923334|Behavioral|Brief Pain Teleconsult|The Brief Pain Teleconsult intervention includes 2 sessions provided by a licensed physical therapist over about 1 week. The sessions focus on pain education from a biopsychosocial perspective that is designed to address negative pain appraisals and catastrophizing thoughts, providing advice to be active and engage in exercise and physical activity, and reassurance that activity is beneficial and safe.
15742290|NCT04923334|Behavioral|Telehealth Physical Therapy|The Telehealth Physical Therapy intervention involves weekly telehealth sessions provided over 10 weeks. Telehealth Physical Therapy is provided by a licensed physical therapist. Key components of the intervention include reinforcing biopsychosocial education messages and developing an exercise and physical activity program using cognitive behavioral principles such as goal setting and positive reinforcement. Pain coping strategies including mindful breathing and progressive relaxation techniques will be included.
15742291|NCT04923308|Other|Triage results disclosed|Following the chiropractor triage assessment, the working diagnosis and risk stratification or referral need will be communicated to the specialist using a standardized clinical note, prior to the patient's consultation and without further discussion.
15742292|NCT04923308|Other|Triage results undisclosed|Following the chiropractor triage assessment, the working diagnosis and risk stratification or referral need will not be communicated to the specialist.
15742293|NCT04923295|Drug|Dapagliflozin 10Mg Tab|Effect of Dapagliflozin on ultrafiltration and PET results among peritoneal dialysis patients
15742294|NCT04923282|Biological|single 1-hour IV infusion of 0.8 mg/kg recAP|Intravenous infusion
15742295|NCT04923282|Biological|single 1-hour IV infusion of 1.6 mg/kg recAP|Intravenous infusion
15742296|NCT04923282|Biological|single 1-hour IV infusion of 3.2 mg/kg recAP|Intravenous infusion
15742297|NCT04923282|Biological|1-hour infusions of 1.6 mg/kg recAP on Days 1, 2 and 3|Intravenous infusion
15742298|NCT04923282|Biological|Placebo|Intravenous infusion
15742299|NCT04923269|Drug|LY3532226|Administered SC.
15742300|NCT04923269|Drug|Placebo|Administered SC.
15742301|NCT04923256|Behavioral|AAT-APP: A novel smart-phone approach-avoidance bias modification intervention|Participants allocated to the intervention group will be required to upload photos of drinks they wish to avoid, as well as activities they wish to engage in more, and be trained to avoid and approach by repeatedly 'swiping' images away from and towards themselves, respectively.
15742302|NCT04923256|Behavioral|Sham training control|Complete an AAT on a weekly basis for four weeks
15742303|NCT04923243|Procedure|hip/knee replacement|hip/knee replacement
15742304|NCT04923230|Behavioral|Cannabis Actions and Practices Resource for Parents|The Cannabis Actions and Practices (CAP) resource is a parent-focused approach to help MM parents address marijuana use and attitudes by their adolescents. CAP includes information about the effects of marijuana on adolescent behavioral health, brain development, and social functioning. CAP also integrates motivational strategies to foster The CAP intervention focuses on building parenting skills and teaching strategies to: (1) limit adolescent exposure to cannabis products and parent cannabis use at home, (2) improve parent communication about their MM use, expectations about youth marijuana use, and attitudes about the potential harms of adolescent cannabis use, (3) improve monitoring, and (4) increase positive reinforcement for youth abstinence. Parents meet with an interventionist for two individual 75-minute sessions involving presentations, discussions, and behavioral rehearsal of key parenting skills.
15742305|NCT04923204|Diagnostic Test|Pharmacogenomic-testing with NEUROPHARMAGEN|"This observational retrospective study aims at evaluating the impact of the genetic variation in individual genes on the therapeutic response and side effects profile in a bipolar disorder cohort, using NEUROPHARMAGEN.
~NEUROPHARMAGEN is a pharmacogenomic-based decision support tool that helps clinicians in the selection and dosing of psychoactive drugs based on the integration of pharmacogenetic information."
15742306|NCT04923191|Other|Angiography-derived physiology guidance/Local routine diagnostic procedure (LRDP) and usual care|percutaneous coronary intervention
15742307|NCT04923165|Device|robotic assisted intervention|Robotic treatment of the upper limb (30 sessions, 5 times a week) using a set of 4 robotic devices: Motore (Humanware); Amadeo, Diego, Pablo (Tyromotion). The training will include motor-cognitive exercises specifically selected to train spatial attention, vision and working memory, praxis, executive function, and speed of processing.
15742308|NCT04923165|Diagnostic Test|biochemical analyses|ematochemical and biochemical serum analyses at T0 and at T1; oxidative stress analyses;
15742309|NCT04923165|Device|BIA, hand grip|bioimpedentiometric analyses of muscular mass (T0 and T1) , muscular force with hand grip
15742310|NCT04923165|Diagnostic Test|nutritional assessment, MNA|nutritional status assessment with MNA, body mass index measurements, weight loss detection, food income detection
15742311|NCT04923152|Drug|moderate statin dose|5 mg rosuvastatin per day
15742312|NCT04923152|Drug|high dose statin|40 mg rosuvastatin per day
15742313|NCT04923139|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Dosage at the discretion of the treating physician
15742314|NCT04923126|Drug|Mirdametinib|By mouth, nasogastric (NG) tube or gastrostomy tube (G-tube) BID, days 1-28
15742315|NCT04923113|Diagnostic Test|Histology，13C urea breath test，Stool antigen test，Serological antibody test for H.pylori and Serologic test with a current infection marker of H.pylori|The above 5 detection methods will be performed in patients who meet the inclusion criteria to detect H. pylori infection
15742316|NCT04923113|Drug|Rabeprazole，Minocycline，Amoxicillin and Colloidal bismuth pectin|Helicobacter pylori positive patients will be treated with rabeprazole10mg,minocycline 100mg,amoxicillin1000mg,and colloidal bismuth pectin 200mg,all twice daily for 10 days
15742317|NCT04923087|Device|Compare the noise and pleasure of crunching between two hyperprotein nutritional supplements|"Validate the evaluation criteria Do you hear the biscuit crunch? and Is it a pleasure?"
15742318|NCT04923074|Other|diffusion tensor imaging(DTI) evaluation|DTI is a new kind of MRI technique to evaluate peripheral neuropathy
15742348|NCT04922801|Device|Patient-led radiation monitor (SELFIE)|"Following MRT administration, a standard whole body dosimetry measurement will be taken by medical physicist at 1 and 2 meters distance. The patient will begin to take SELFIE readings at the same time under supervision so that their records can be compared with the physicists' results.
~After 28 days, patients will be asked to return the diary sheet and SELFIE monitor by post to GSTTFT in a pre-paid, pre-addressed envelope.
~On completion of the 28 day exercise, patients will be asked to complete and return a feedback questionnaire."
15742319|NCT04923061|Other|Acupressure|In the acupressure group, heart meridian 7th point (HT7), large intestine meridian 4th point, stomach meridian 36th point (ST36) and spleen meridian 6th point (SP6) will be applied. Tissue sensitivity will be reduced by heating and rubbing for about 20 seconds without direct pressure on the acupressure points, and the points will be ready for acupressure application. Subsequently, consecutive (breathing rhythm) compressions will be applied to the acupressure points determined by the researcher, without raising the finger, taking into account the pain threshold of the individual who is applied with the thumb, with 10 seconds of pressure for two seconds of relief Since the symmetry of the selected four different points will also be applied to the other extremity, a total of 16 minutes of compression will be applied to each point, provided that it is two minutes. Each nurse's session will be approximately 20 minutes, depending on the preparation and compression time on each point.
15742320|NCT04923061|Other|Sham acupressure group|In the sham group, acupressure will be applied on the bone region where the meridians do not pass, approximately 1-1.5 cm away from the HT7, LI4, ST36, SP6 points. The application process will continue in the same way with acupressure group and the pressure intensity will be less.
15742321|NCT04923048|Biological|GB261|Drug:GB261 IV, participants with B-cell NHL or CLL will receive GB261 via IV infusion weekly for the first two cycles(1cycle=21days), followed by Q3W from C3 and afterwards in given doses until progression disease or other situations specified in the protocol, whichever comes earlier.
15742322|NCT04923022|Other|Vegan Diet|Participants with chronic neck pain who will be on a vegan diet will follow a diet program prepared by an expert dietitian under the supervision of an endocrinologist. In this diet program, a diet that includes grains, fruits, vegetables, legumes, as well as dairy products and eggs, known as lacto-ovo vegetarian, will be applied. Consumption of meat, poultry, fish, seafood and processed food and beverages will not be allowed. There will be no calorie restriction in the diet, and the diet will be arranged according to the amount of calories calculated by the expert dietitian according to BMI. The diet will last eight weeks. Individuals who follow a diet will be constantly checked by the workers with the mobile device application (My Fitness Pal®).
15742323|NCT04923022|Other|Therapeutic exercise|Individuals in the therapeutic exercise group will perform therapeutic exercises for eight weeks, 3 days a week, accompanied by a specialist physiotherapist.
15742324|NCT04923009|Procedure|ICE visualization and map construction|Radio-frequency ablation of atrial fibrillation
15742325|NCT04922996|Drug|Calcium Dobesilate|Dosage of calcium dobesilate in different tissues
15742326|NCT04922983|Drug|Botulinum toxin type A|A position similar to the side-plank (Vasisthasana) held for maximal time at least once daily (usual duration: 30 - 90 seconds).
15742327|NCT04922983|Behavioral|Isometric Yoga-like exercise|Extended torso and legs held diagonally by one straight arm, back against wall if necessary
15742328|NCT04922983|Behavioral|Placebo|Used as placebo
15742329|NCT04922970|Other|Strength training|The interventon consist of 3 weekly, supervised group sessions for 4 months (16 weeks). The sessions consist of progressive full body strength training with a primary focus on lower extremity muscle strength. The leg exercises are leg press, knee extension and leg curl. In addition, participants will perform two upper body exercises. Physical assessment will take place immediately and monthly until 4 months.
15742330|NCT04922957|Drug|ALLOCETRA-OTS|The product contains allogeneic donor mononuclear enriched cells in the form of a liquid suspension containing early apoptotic cells.
15742331|NCT04922957|Other|Placebo|Ringer's lactate solution
15742332|NCT04922944|Drug|COVID-19 vaccine|Two-dose COVID-19 vaccine
15742333|NCT04922931|Procedure|scheduled surgery|Patients undergoing scheduled surgery with lung ultrasound before surgery and determination of lung compliance during general anesthesia
15742334|NCT04922918|Biological|Ligilactobacillus salivarius MP101|Administration of the strain through a fermented milk
15742335|NCT04922905|Other|NEURO +|"The participants will undergo several questionnaires after their classic clinical evaluation allowing to determine the Clinical Assessment Scale in Autoimmune Encephalitis (CASE) score :
~The dissociative peri-traumatic experiences questionnaire (Birmes et al., 2005)
~the Peri traumatic distress inventory (Jehel et al., 2005)
~and the Shortness, Trembling, Racing, Sweating (STRS) (Bracha et al., 2004)
~Neuro + patients will also have a Brain MRI, cerebrospinal fluid analysis, EEG, as well as an ambulatory sleep recording and electromyography depending on the symptoms observed."
15742336|NCT04922905|Other|NEURO -|"The participants will undergo several questionnaires after their classic clinical evaluation allowing to determine the Clinical Assessment Scale in Autoimmune Encephalitis (CASE) score :
~The dissociative peri-traumatic experiences questionnaire (Birmes et al., 2005)
~the Peri traumatic distress inventory (Jehel et al., 2005)
~and the Shortness, Trembling, Racing, Sweating (STRS) (Bracha et al., 2004)"
15742337|NCT04922892|Procedure|Parathyroidectomy|Total Parathyroidectomy With Autotransplantation or Total Parathyroidectomy Alone
15742338|NCT04922879|Behavioral|Individualized lung rehabilitation|Early respiratory function training, reasonable oxygen therapy to prevent hypoxemia, Positive pressure vibration training to promote coughing ability recovery, early exercise, Health education and psychological support.
15742339|NCT04922866|Other|no intervention|no intervention
15742340|NCT04922853|Drug|Capox chemotherapy|oxaliplatin: 130 mg/m2 iv d 1, capecitabine: 1000 mg/m2 bid d 1-14, repeated at 3 week intervals
15742341|NCT04922840|Behavioral|High-intensity exercise (HIT)|12 week intervention: Two weekly sessions of 35-40 min exercise: 10 min warm-up, followed by 4x4 min at 90-95% peak heart rate (HRpeak) interspaced by 2-3 min active breaks at 60-70% HRpeak and a third weekly session with continuous exercise for a minimum of 40 min at moderate intensity.
15742342|NCT04922827|Drug|Infliximab|single intravenous administration of 5 milligrams/kilogram
15742343|NCT04922827|Other|Standard of Care|Standard of Care
15742344|NCT04922814|Drug|muscle relaxation|They will receive muscle relaxation treatment for at least 48 hours. Cisatracurium will be given. Short term infusions up to 24 hours will be given in a dose rate of 2-3 mic/Kg/min followed by intervallic shots of 2-5 mg.
15742345|NCT04922801|Diagnostic Test|Nuclear Medicine whole-body|Gamma-Camera Whole-body scan at 24-48 hour post-Molecular Radiotherapy (MRT).
15742346|NCT04922801|Diagnostic Test|SPECT/CT imaging.|SPECT/CT scan at 24-48 hr post MRT
15742347|NCT04922801|Diagnostic Test|PET/CT imaging.|3-6 months Pre and post-therapy PET/CT imaging
15742349|NCT04922801|Diagnostic Test|LAB TEST|Biochemistry, haematology and tumour markers blood tests pre, post and during MRT.
15742352|NCT04922775|Procedure|conventional taping|Participants will accept conventional taping before muscle fatigue exercise.
15742353|NCT04922775|Procedure|Chinese medicine technique taping|Participants will accept Chinese medicine technique taping before muscle fatigue exercise.
15742354|NCT04922762|Behavioral|Moderate Intensity, Normal Volume Exercise Training|"Week 1 3 days/week for 20 minutes/day Performed at 70% of heart rate maximum
~Week 2 3 days/week for 30 minutes/day Performed at 70% of heart rate maximum
~Weeks 3-10 3 days/week for 45 minutes/day Performed at 70% of heart rate maximum"
15742355|NCT04922762|Behavioral|High Intensity, Normal Volume Exercise Training|"Week 1 3 days/week for 31 minutes/day 10 minute warm up at 50% of heart rate maximum 2 x 4 minute intervals 4 minutes at 90-95% of heart rate maximum 3 minutes at 70% of heart rate maximum REPEAT 7 minute cool down at 50% of heart rate maximum
~Week 2 3 days/week for 38 minutes/day 10 minute warm up at 50% of heart rate maximum 3 x 4 minute intervals 4 minutes at 90-95% of heart rate maximum 3 minutes at 70% of heart rate maximum REPEAT 2 TIMES 7minute cool down at 50% of heart rate maximum
~Weeks 3-10 3 days/week for 45 minutes/day 10 minute warm up at 50% of heart rate maximum 4 x 4 minute intervals 4 minutes at 90-95% of heart rate maximum 3 minutes at 70% of heart rate maximum REPEAT 3 TIMES 7 minute cool down at 50% of heart rate maximum"
15742356|NCT04922762|Behavioral|Moderate Intensity, High Volume Exercise Training|"Week 1 5 days/week for 20 minutes/day Performed at 70% of heart rate maximum
~Week 2 5 days/week for 30 minutes/day Performed at 70% of heart rate maximum
~Weeks 3-10 5 days/week for 45 minutes/day Performed at 70% of heart rate maximum"
15742357|NCT04922749|Behavioral|MULTI+|MULTI+ is a multidisciplinary, multicomponent treatment which aims to improve lifestyle factors through a holistic lifestyle approach, by focusing on 10 core components. The MULTI+ will be integrated into daily treatment to promote uptake and sustainability.
15742358|NCT04922736|Device|UVA-1 Phototherapy|All patients will receive UVA-1 Phototherapy treatments
15742359|NCT04922723|Drug|Daratumumab|Daratumumab will be administered by IV infusion to subjects in combination with current therapeutic strategies of surgical resection followed by a course of Temozolomide and radiation therapy.
15742360|NCT04922710|Behavioral|Home-based aerobic exercise|Guidelines for exercise programming (ACSM, 2018) will be followed including a warmup and cool down, progressive and gradual increments in duration, and instruction regarding avoidance of physical activity related injury. The exercise group will receive moderate to vigorous intensity aerobic exercise for 60 minutes per day, three times a week, for 12 weeks. The prescribed intensity will be based on estimated heart rate reserve, calculated using resting heart rate and age-adjusted heart rate maximum (220-age in years). Participants will maintain a minimum heart rate from their specific calculation that will be monitored by Polar Heart Rate straps.
15742363|NCT04922684|Behavioral|Mimic facial expressions|16 times (4 times a week, last 4 weeks) of mimicking facial expressions.
15742364|NCT04922658|Drug|Surufatinib|Surufatinib,250mg ,qd,po, 21 days for a cycle; continuous administration until PD, death or intolerable toxicity.
15742365|NCT04922658|Drug|Surufatinib Plus Vinorelbine|Surufatinib,250mg ,qd,po; Plus Vinorelbine, 60 mg / m2 BSA, d1, d8, d15; 21days for a cycle; continuous administration until PD, death or intolerable toxicity.
15742366|NCT04922645|Drug|Ferric Citrate 1 gram Oral Tablet|Ferric citrate is an iron-based phosphate binder for the treatment of hyperphosphatemia in subjects with dialysis-dependent chronic kidney disease (DD CKD) and for the treatment of iron deficiency anemia (IDA) in subjects with non-dialysis dependent chronic kidney disease (NDD CKD).
15742367|NCT04922645|Drug|Standard of care phosphate-lowering therapy|Subjects randomized to SOC will continue their currently prescribed dose of phosphate lowering therapy which will be dosed per local standard of care to achieve community target serum phosphate goals.
15742368|NCT04922632|Behavioral|Transcendental Meditation (TM)|TM is a mind-body program that allows the participant to experience progressively quieter, less excited states of mental activity, with growing experience of restful alertness in mind and body.
15742369|NCT04922632|Behavioral|Experience Resolution Methodology (ERM)|ERM is a specific, protocolized coaching method that aims to maximize an individual's performance, professional development and well-being by recognizing and resolving subjective stress associated with specific situations, circumstances, events or experiences.
15742370|NCT04922632|Behavioral|Transcendental Meditation (TM) and Experience Resolution Methodology (ERM)|TM + ERM is an integrative method using both TM and ERM coaching with ERM with the aim of achieving an overall restful, alertness in mind and body and maximizing performance, professional development and well-being.
15742371|NCT04922632|Behavioral|Treatment As Usual (TAU)|TAU is the existing Duke Health & Well-being services, such as the availability of acupuncture, integrative health coaching, integrative nutrition and weight management, personal exercise training, massage therapy, yoga therapy, mindfulness-based stress reduction (MBSR), experiencing mindfulness, group fitness classes, gentle yoga, or chair yoga, as well as additional resources such as Personal Assistance Services (PAS).
15742374|NCT04922606|Diagnostic Test|US ot the GSV|Ultrasound of the Great Saphenous Vein
15742375|NCT04922593|Drug|LY03010; paliperidone palmitate|LY03010 is white to off-white sterile aqueous extended-release suspension of paliperidone palmitate for IM injection.
15742376|NCT04922593|Drug|INVEGA SUSTENNA|INVEGA SUSTENNA (234 mg, 156 mg) is manufactured by Janssen Pharmaceuticals, Inc and is commercially available.
15742377|NCT04922567|Drug|Lenalidomide|25mg po on day 1-10
15742378|NCT04922567|Drug|Cyclophosphamide|750mg/m² iv on day1
15742379|NCT04922567|Drug|Doxorubicin|50mg/m² iv on day 1
15742380|NCT04922567|Drug|Vincristine|1.4mg/m² iv on day 1
15742381|NCT04922567|Drug|Prednisone|100mg po on day1-5
15742384|NCT04922541|Drug|PD-1 inhibitor|dosage form: intravenous injection; frequency: 2-3 weeks; duration: at least 3 months
15769054|NCT04703608|Drug|Placebo|Non-identical placebo
15742385|NCT04922528|Procedure|Laparoscopic Cholecystectomy with Fluorescent Cholangiography|Indocyanine green is a fluorophore molecule which is metabolized by the liver and excreted exclusively through the biliary system. Intra-operatively, near-infared imaging via the laparoscope will be used to visualize the biliary anatomy in the intervention arm, as an adjunct to standard of care white-light imaging.
15742386|NCT04922528|Procedure|Laparoscopic Cholecystectomy with White Light Imaging|As per the current standard of care, patients undergoing laparoscopic cholecystectomies will have it completed using white light imaging through the laparoscope.
15742387|NCT04922515|Other|Oral and rectal swabs for microbiome sequencing|Oral swabs and rectal swabs are collected non-invasively.
15742388|NCT04922502|Behavioral|Standard SPACE|12 one hour parent sessions over 12 weeks in which the therapist guides the parent to target anxious behaviors and support adaptive child behaviors.
15742389|NCT04922502|Behavioral|Bibliotherapy, low therapist contact SPACE|"4 one hour parent sessions over 12 weeks in which the therapist supports the parent in understanding and implementing content reviewed in the book Breaking Free of Child Anxiety and OCD."
15742390|NCT04922489|Procedure|Dental implant placement|Dental implant placemente on edentulous jaw.
15742391|NCT04922476|Dietary Supplement|Alflorex®|Each probiotic capsule contains 1 x 10^9 CFU of B. longum 35624® and corn starch, hydroxypropyl methyl cellulose and magnesium stearate.
15742392|NCT04922463|Device|PLASOMA|Treatment with cold plasma device
15742393|NCT04922450|Drug|PD-1 inhibitor|Intravenous administration of SHR1210 (200mg/3weeks)
15742394|NCT04922450|Drug|Albumin Paclitaxel|Albumin Paclitaxel(260mg/m²),every 3 weeks
15742395|NCT04922450|Drug|Cisplatin|Cisplatin（80mg/m²）, every 3 weeks
15742396|NCT04922437|Procedure|Native bladder implantation|Continent catheterizable channel implanted in the detrusor of the native bladder
15742397|NCT04922437|Procedure|Enterocystoplasty implantation|Continent catheterizable channel implanted by seromuscular plicature on the front wall of the bladder augmentation
15742398|NCT04922424|Drug|Atorvastatin|Subjects will ingest placebo or ingest 20 mg atorvastatin for 30 days first. We will include 30 days of washout between treatments to minimize any potential carryover effects.
15742399|NCT04922424|Other|placebo|Subjects will ingest placebo or ingest 20 mg atorvastatin for 30 days first. We will include 30 days of washout between treatments to minimize any potential
15742400|NCT04922398|Biological|platelet rich plasma|blood will be withdrawn from the patient then separation of the platelet rich layer and then injection in the ovary
15742401|NCT04922398|Drug|Normal saline|0.9% normal saline will be injected in each ovary
15742402|NCT04922385|Other|Cognitive Behavioural Therapy|This study is an open waitlist control study. Eligible participants will be assigned to a treating clinician and will complete 4 weeks of treatment, followed by a post-treatment assessment (2 weeks later). If a treating clinician is not immediately available, participants will be placed on their waitlist for 4 weeks. They will then be assessed after 4 weeks and undergo the 4 week treatment, followed by the post-treatment assessment (2 weeks later).
15742403|NCT04922372|Combination Product|peek|After tooth preparation, adequate 2ry Impression using non aqueous elastomeric impression materials and bite registration will be taken. 5. Fabrication of the temporary restoration using composite resin temporary material and cemented using non Eugenol Zinc Oxide temporary cement. 11.a.iii. Fabrication and cementation of restoration: Bio-HPP will be supplied in the form of discs to fabricate crown core by CAD/CAM technology then veneered with two veneering techniques; the CAD/ CAM and the manual technique using the visio.lign system of appropriate shade. The finished Bio HPP crown will be cemented by adhesive resin cement according to manufacturer instruction
15742404|NCT04922359|Drug|Lidocain|Patients received 1.5mg/kg of intravenous lidocaine during induction of anesthesia and 1.5 mg/kg/h for anesthesia maintenance.
15742405|NCT04922359|Drug|normal saline|Patients received 0.075ml/kg of intravenous normal saline during induction of anesthesia and 0.075ml/kg/h for anesthesia maintenance.
15742406|NCT04922333|Drug|Risedronate|150mg over-encapsulated risedronate
15742407|NCT04922333|Drug|Placebo|Capsules containing placebo tablets
15742408|NCT04922320|Behavioral|Patient Priorities Care|A facilitator will schedule a PPC facilitation encounter 2-3 weeks before an upcoming PCP visit. The facilitator conducts a structured assessment using a written conversation guide that begins with general questions establishing what is most important to Veterans about their health and moves toward establishing specific goals (actionable outcomes), and what patients are willing/not willing to do to achieve these goals (care preferences). The result is a structured patient priorities report delivered to PCPs designed to facilitate changes in the patient's care plan to align it with his/her priorities. In the subsequent visit, the PCP will use one or more of the established PPC decisional strategies to align care with patients' priorities. Education for PCPs about the facilitation process, the patient priorities report, and the decisional strategies occurs prior to the PCP seeing any intervention patients. The PCP will document changes in care made to achieve the identified priorities.
15742409|NCT04922320|Other|Usual Care|PCPs will not be alerted when an encounter involves a UC group participant. UC participant visits will appear the same as all other unenrolled patient encounters. PCPs will be trained to address the needs of UC participants based on their typical approach without the use of a facilitator or explicit process for identifying patient priorities. UC participants will not receive any additional preparation
15742410|NCT04922307|Procedure|Blood Sparing Protocol|Acute Normovolemic Hemodilution, Cell Saver, and/or Veno-venous Bypass
15742411|NCT04922307|Procedure|Standard Blood Replacement|Allogenic blood transfusion as determined intra-operatively
15742412|NCT04922294|Other|Clinical decision support system|To develop a clinical decision support system based on a published cardiometabolic disease staging system.
15742413|NCT04922281|Device|Insertable Cardiac Monitor|Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.
15742414|NCT04922268|Other|Internal focus of attention feedback|Participants will complete 12 sessions over a 3-week period of functional movement retraining while receiving mirror feedback. Participants will be instructed to perform each functional task in a manner that keeps their knee in line with their toes.
15742526|NCT04921371|Other|Concept Curve Winter Series Toothbrush|Participants will brush twice daily for 1 minute with the toothpaste and soft bristled toothbrush provided.
15743157|NCT04915703|Procedure|Flushing of PTBD catheter|flushing of internal external PTBD catheter 3 times a day
15742415|NCT04922268|Other|External focus of attention feedback|Participants will complete 12 sessions over a 3-week period of functional movement retraining while receiving visual feedback via laser. Participants will be instructed to perform each functional task in a manner that does causes the laser to move up and down but not side-to-side.
15742416|NCT04922255|Device|Reusable Underwear|Reusable Underwear are similarly available for purchase online and are absorbent underwear for bladder leak protection
15742417|NCT04922255|Device|Disposable urethral support|The disposable urethral support is a tampon-like device that is available over the counter to help women with urinary incontinence (UI)
15742418|NCT04922255|Behavioral|Pelvic floor physical therapy|Experienced pelvic health physical therapists (at University of Pittsburgh) will complete two visits one week apart.
15742419|NCT04922242|Behavioral|Welch Emotional Connection Screen for Neonatal Intensive Care Unit|The Welch Emotional Connection Screen (WECS) is an investigational developmental screening tool, developed to rate the quality of the emotional connection that formed between mother and child. The screen is administered in 2-3 minutes by observing a mother and child interact, and requires the rater to critically assess 4 sub-domains of emotional connection. The NICU WECS is a clinical tool adapted for use with neonates in the NICU. Reliability of NICU staff WECS scoring will be calculated via intra-class correlations with key scores. The WECS is scored on intervals of 0.5, with a minimum of 1 (rarely--low level of connection) and maximum of 3 (mostly--high connection). Scores are used to determine the level of need for intervention.
15742420|NCT04922242|Other|NICU WECS Training|"WECS Training is an educational module consisting of an introduction of the concepts of emotional connection and autonomic co-regulation as studied by The Nurture Science Program, as well as an illustration of how these experiential constructs differ from traditional care plans that focus on educating parents to encourage bonding as opposed to autonomic emotional connection within the NICU. An introduction to the domains of the WECS screen as well as illustrations of these domains through video will augment the training designed for NICU staff."
15742421|NCT04922229|Procedure|RCT|This is the standard of care for this diagnosis
15742422|NCT04922229|Procedure|VPT|For cases with normal apical tissues, this VPT using tricalcium silicates has been shown to have high clinical success. Either pulpotomy of direct pulp capping will be performed depending on the size of pulp exposure.
15742423|NCT04922216|Behavioral|Core|Behavioral weight loss core includes behavioral lessons, activity tracker, daily self-weighing, weekly tailored feedback summary.
15742424|NCT04922216|Behavioral|Standard Diet Monitoring|Standard monitoring using smartphone tracking of all calorie intake.
15742425|NCT04922216|Behavioral|Simplified Diet Monitoring|Simplified diet monitoring using smartphone tracking of red foods using a traffic light approach.
15742426|NCT04922216|Behavioral|Adaptive Activity Goals (Daily)|Physical activity goals that adapt once each day using the participants' data derived from activity tracker.
15742427|NCT04922216|Behavioral|Adaptive Activity Goals (Weekly)|Physical activity goals that adapt once each week using the participants' data derived from activity tracker.
15742428|NCT04922216|Behavioral|Message Decision Points (Fixed)|Message timing is fixed and evaluated at specific times each day to determine message eligibility.
15742429|NCT04922216|Behavioral|Message Decision Points (Adaptive)|Message timing is adaptive and derived from individual user data to determine message eligibility.
15742430|NCT04922216|Behavioral|Message Decision Rules (Standard)|Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors.
15742431|NCT04922216|Behavioral|Message Decision Rules (Adaptive)|Decision rules to determine eligibility to receive just-in-time messages consider participant's recent behaviors and overall progress.
15742432|NCT04922216|Behavioral|Message Choice (No)|Participant choice does not drive adaptation of 1) message type delivered or 2) lapse support provision
15742433|NCT04922216|Behavioral|Message Choice (Yes)|Participant choice drives adaptation of 1) message type delivered and 2) lapse support provision.
15742434|NCT04922203|Other|in Situ Simulation|2 sessions of in situ simulation with 4 crisis scenarios and debriefing focused on non technical skills
15742435|NCT04922190|Behavioral|Physical Activity Coaching|Participants will receive up to 5 coaching sessions by a physical or occupational therapist. The intervention will focus on facilitating physical activity engagement and development of specific and measurable goals. The recommended program will be individualized to each participant but will primarily focus on increasing general physical activity (e.g. steps per day) as well as engagement in moderate intensity aerobic exercise a minimum of three times per week. At the follow up sessions the therapist will review progress with the current exercise plan and progress and discuss barriers and facilitators for exercise engagement. Participants will have the option to use a Fitbit or other device to monitor their heart rate and physical activity during the course of the intervention period.
15742436|NCT04922177|Procedure|Indirect ceramic restoration|Indirect ceramic restoration using an optical impression.
15742437|NCT04922177|Procedure|Direct restoration|Restoration using a Glass Ionomer Cement
15742438|NCT04922164|Behavioral|Cue intervention|"Around 30 pieces of narrative information about how a mother behaves in specific decision context will be derived from our qualitative study to construct social normative cues.
~For goal-related cues, words relating to each category of breastfeeding-related values, benefits and goals will be identified and used to construct the messages (e.g. attractive body shape, smart baby, natural, strong immunity and etc.). Each goal-priming message will be presented with brief priming words and a picture of an image of the desirable goal."
15742439|NCT04922151|Drug|601|intravitreal recombinant humanized anti-VEGF monoclonal antibody
15742440|NCT04922151|Drug|Ranibizumab|intravitreal recombinant humanized anti-VEGF monoclonal antibody
15742441|NCT04922138|Drug|Aumolertinib|All subjects who meet the enrollment conditions will be included in the Aumolertinib monotherapy group: Orally 110 mg Aumolertinib tablets (55 mg/tablet, 2 tablets/day) once a day until recurrence or completion of treatment or reaching the standard of discontinuation.
15742442|NCT04922125|Combination Product|Pulse flour|Traditionally processed pulse flour in vitro digestion conditions were related to potentially influence appetite sensations.
15742443|NCT04922125|Combination Product|Pre-processed pulse flour|Pre-processing of pulse flour was related to altered in vitro digestion conditions and thus suggested to potentially influence appetite sensations.
15742559|NCT04921085|Other|Cross-sectional obeservational survey|Cross-sectional obeservational survey
15742444|NCT04922112|Diagnostic Test|Obstructive sleep apnea testing|"Functional Outcomes of Sleep Questionnaire (FOSQ-10)
~European Organization for Research and Treatment of Cancer Head and Neck Survey (EORTC HN 35)
~Epworth Sleepiness Scale (ESS)
~Adult Comorbidity Evaluation (ACE 27)
~University of Washington Quality of Life Questionnaire (UW-QOL)
~Chronic Pain Assessment Questionnaire"
15742445|NCT04922099|Device|glycemic gap|"Measurements of HbA1c-based adjusted glycemic gap:
~The estimated chronic average glucose levels (eAG) over the past 3 months will calculate from the equation AG = 28.7 × HbA1c - 46.7 Glycemic gap was calculated as the ADAG level subtracted from the admission glucose level."
15742446|NCT04922086|Procedure|Conventional aesthetic crown lengthening surgery|The demarcation of the gingival zenith final position will be done on the teeth using a periodontal probe. This demarcation will be done through visual examination based on the crown length/width ratio and the position of the cemento-enamel junction (CEJ). The gingival margin of the central and canine incisors will be positioned at similar heights and a more coronal gingival contour will be determined for the lateral incisors. An internal bevel incision will be made with a blade on each tooth, preserving the interdental papillae. The incised gingival tissue will be removed using a periodontal curette in both groups. An internal bevel incision will be made in the involved teeth and a full thickness flap will be displaced up to the the mucogingival junction level to expose the bone crest (BC). Carbide drills and manual chisels will be used for bone resection to obtained a CEJ-BC distance of 3 mm. Simple interproximal interrupted sutures will be performed.
15742447|NCT04922086|Procedure|Guided dual aesthetic crown lengthening surgery|The double guide will be positioned and an internal bevel incision on each tooth will be made following the guide demarcation. After the initial incision, the incised gingival tissue will be removed using a periodontal curette. An internal bevel incision will be made in the involved teeth and a full thickness flap will be displaced up to the the mucogingival junction level to expose the bone crest (BC). The dual guide will be positioned again and the bone tissue will be removed using carbide drills and manual chisels following the double guide. No interproximal crestal bone will be removed. Simple interproximal interrupted sutures will be performed to stabilize the flap.
15742448|NCT04922047|Drug|tislelizumab and BCG|Tislelizumab 200 mg administered by intravenous infusion every 3 weeks in first year and continue to second year based on physician choose. BCG 120 mg induction therapy administered via intravesical instillation (once weekly for 6 weeks). BCG induction therapy is followed by maintenance therapy (once weekly for 3 weeks at months 3, 6, 12, 18, 24m).
15742449|NCT04922034|Drug|Amoxicillin|Outcome of patients with negative oral challenge to amoxicillin
15742452|NCT04922008|Drug|capecitabine and trastuzumab|In IRIS-C cohort, patients who met the inclusion criteria(ER and PR<10%, T≤2cm or ER and/or PR ≥10% 1cm<T≤2cm) would be given capecitabine for 4 cycles with standard trastuzumab for 1 year, in which HR+ patients would be given endocrine therapy for 5 years.
15742453|NCT04922008|Drug|vinorelbine and trastuzumab|In IRIS-4 cohort, patients who met the inclusion criteria(ER and PR<10%, T≤2cm or ER and/or PR ≥10% 1cm<T≤2cm) would be given vinorelbine for 4 cycles with standard trastuzumab for 1 year, in which HR+ patients would be given endocrine therapy for 5 years.
15742454|NCT04921995|Drug|Tislelizumab|"Chemotherapy (including but not limited to following):
~GP regimen: gemcitabine 1000mg/m2 d1, d8 + cisplatin 25 mg/m2 d1-3, every 3 weeks for 4 cycles; TP regimen: docetaxel 75mg/m2 d1 + cisplatin 25 mg/m2 d1-3, every 3 weeks for 4 cycles; GT regimen: gemcitabine 1000mg/m2 d1 + docetaxel 75mg/m2 d1, every 2 weeks for 6 cycles; S-1 : twice per day oral dose of 40mg for BSA<1.25, 50 mg for 1.25≤BSA<1.5 and 60mg for BSA≥1.5.
~anti-PD-1 antibody: Tislelizumab concurrently with chemotherapy: 200mg, every 3 weeks for 12 weeks. Tislelizumab in maintenance period: 200mg every 3 weeks or 400mg every 6 weeks, until one year or disease progression, or in the case of intolerable toxicities."
15742455|NCT04921982|Drug|Propranolol|Oral administration of Propranolol, 90 minutes prior to a brief memory reactivation session, performed by a trained nurse once a week for six consecutive weeks.
15742456|NCT04921982|Drug|Placebo|Oral administration of Placebo, 90 minutes prior to a brief memory reactivation session, performed by a trained nurse, once a week for six consecutive weeks.
15742457|NCT04921969|Drug|Ruxolitinib|The study cream will be applied topically twice a day for up to 52 weeks.
15742458|NCT04921969|Drug|Vehicle Cream|Matching vehicle cream will be applied topically twice a day for up to 8 weeks.
15742459|NCT04921956|Drug|Concizumab|Injected under the skin (subcutaneous, sc) once daily, individual dose adjustment.
15742460|NCT04921943|Drug|Hypertonic saline|Nebulizing with 7% hypertonic saline twice daily for 12 weeks.
15742461|NCT04921943|Drug|Azithromycin|Standard of care
15742462|NCT04921943|Drug|Ethambutol|Standard of care
15742463|NCT04921943|Drug|Rifampin|Standard of care
15742464|NCT04921930|Drug|Artesunate Oral Product|Dose escalation intake of artesunate
15742465|NCT04921917|Other|neoadjuvant exercise therapy|brief exercise regimen completed immediately prior to neoadjuvant radiation therapy. Rubber bands will be used for the exercise training of patients with lower extremity tumors while an electronic hand-held dynamometer will be used for the exercise training for patients with upper extremity tumors.
15742466|NCT04921904|Drug|Abemaciclib|150mg dose administered orally twice daily every day
15742467|NCT04921904|Drug|Ramucirumab|8mg/kg iv every 2 weeks until evidence of disease
15742468|NCT04921891|Procedure|Infraclavicular nerve block|The investigators performed an infraclavicular nerve block to the operated arm group to provide anesthesia.
15742469|NCT04921891|Procedure|Without nerve block|The upper extremity without block was assigned as the control group, and a comparison was made between the two upper extremities.
15742470|NCT04921878|Drug|Mitoxantrone Hydrochloride Liposome injection|Mitoxantrone hydrochloride liposome injection will be administered intravenously once every 3 weeks (a cycle) for a maximum of 6 cycles.
15742520|NCT04921410|Device|Biofeedback Knee Sleeve|The biofeedback knee sleeve is a device that is artificially-intelligent and utilizes determined cut-off values of knee motion and forces to determine whether a motion is 'good' or 'bad'. A 'bad' knee motion will provide a haptic output to the wearer (biofeedback) so that they can take note of what the previous motion was that caused the device to signal a warning.
15742471|NCT04921865|Device|DPS VA-LCP® Clavicle Plate 2.7 System; DPS VA-LCP® Clavicle Hook Plate 2.7 System|"The DPS VA-LCP® Clavicle Plate 2.7 System is indicated for the fixation of clavicle bone fragments. The system consists of three plate types: lateral, shaft, and medial, each available in different sizes and materials (titanium alloy and stainless steel). Each plate is available in left and right.
~The DPS VA-LCP® Clavicle Clavicle Hook Plate 2.7 System is indicated or the fixation of lateral clavicle fractures and AC joint dislocations. The Clavicle Hook Plate system consists of three plate types: long, short and button plates."
15742472|NCT04921852|Procedure|costoclavicular brachial plexus block|A transverse scan with an portable USG machine with a high-frequency linear array transducer ((Logiq E, General Electric, ABD) will be performed immediately below the midpoint of the clavicle and over the medial infraclavicular fossa. 20 ml of a mixture of 0.25% bupivacaine, 1% lidocaine will be injected in to the middle of the three brachial plexus cords with an echogenic SonoTAP(Pajunk GmbH Medizintechnologie, Geisingen, Germany) block needle under USG guidance .Readiness for surgery time will be evaluated after costoclavicular block.
15742473|NCT04921852|Procedure|lateral sagittal infraclavicular block|A sagittal scan with an portable USG machine with a high-frequency linear array transducer ((Logiq E, General Electric, ABD) will be performed medial to the coracoid process to obtain a transverse view of the axillary artery.20 ml of a mixture of 0.25% bupivacaine, 1% lidocaine will be injected posterior to the axillary artery near to the three cords of brachial plexus with an echogenic SonoTAP(Pajunk GmbH Medizintechnologie, Geisingen, Germany) block needle under USG guidance.Readiness for surgery time will be evaluated after lateral sagittal infraclavicular block.
15742474|NCT04921826|Other|online survey|online survey
15742475|NCT04921813|Other|3 dimensional scoliosis exercise|Schroth exercises
15742476|NCT04921813|Other|Balance Exercise|Balance-coordination exercises
15742477|NCT04921813|Other|Brace treatment|Brace usage
15742478|NCT04921800|Procedure|Anterior Cervical Discectomy & Fusion|Participants are undergoing previously scheduled anterior cervical discectomy & fusion for single level or multiple level cervical disease
15742479|NCT04921800|Device|Application of ADAM mechanoacoustic skin sensor|Applying the ADAM sensor to the suprasternal notch following surgery to allow for collection of the anatomical data
15742480|NCT04921787|Other|Low Intensity|Training and education only, a low-intensity strategy inclusive of an HBOT manual, one-time live training on how to use the HBOT manual, and 7 video conference presentations.
15742481|NCT04921787|Other|High Intensity|Practice facilitation, a high-intensity strategy inclusive of low-intensity training, plus practice facilitation that is based in part on a program planning model. This study is a hybrid implementation effectiveness design, testing an implementation strategy while observing and gathering information on the clinical intervention's impact on relevant outcomes.
15742482|NCT04921761|Procedure|Conventional epidural|In this group, a 20-gauge multi-orifice catheter was threaded through the cephalic-directed tip of the epidural needle 5 cm into the epidural space.
15742483|NCT04921761|Procedure|Dural puncture epidural|In this group, the dura was punctured by 25G Whitacre needle. After confirmation of CSF flow, the needle was removed and the epidural catheter was threaded.
15742484|NCT04921748|Procedure|Neurorehabilitation|All patients will be treated with an in-hospital rehabilitation program focused on the rehabilitation of gait disorder in PD with 90-minute daily sessions, 6 days a week (Monday through Saturday) for four weeks. The rehabilitation treatment includes passive, active-assisted, and active exercises, isotonic and isometric exercises for the major muscles of the limbs and trunk, cardiovascular warm-up exercises, muscle stretching exercises for functional purposes, balance training exercises, specific motor exercise for hypokinesia, and 45 minutes of overground gait training delivered without devices or cueing The rehabilitation program is the same in PD patients with and without FOG.
15742485|NCT04921735|Drug|Cisatracurium|0.15 mg/kg based on ideal body weight calculated as height (cm) minus 105 for women and height (cm) minus 100 for men or actual body weight, whichever is lower
15742488|NCT04921709|Other|Medical tests|Blood tests
15742489|NCT04921696|Other|RBC transfusion|RBC was transfused to the infants.
15742490|NCT04921696|Other|no-RBC transfusion|RBC was not transfused to the infants.
15742491|NCT04921683|Device|BX Pulsar 1002 (LIFUP) Low intensity Focused Ultrasound Pulsation|"Administration of LIFUP will be performed at the bedside using frameless stereotaxy. Specifically, the LIFUP transducer will be fit to the patient's head employing adjustable straps, and will be positioned over the patient's left temporal bone, over the temporal window in order to minimize bone absorption and refraction. Accurate aiming will be ensured employing the BrainSight neuronavigation device, customized for tracking our LIFUP transducer (total ~10 min). Once satisfactory aiming is achieved, the LIFUP exposure will be initiated employing the settings described previously (which meet the FDA safety limits: ISPPA <= 190W/cm2, ISPTA <= 0.72W/cm2). Accurate aiming will be monitored in real-time throughout exposure using the Brain Sight Neuronavigation interface."
15742492|NCT04921670|Diagnostic Test|Infliximab Assay|Participants will be assigned to standard of care or proactive drug monitoring, which is measuring infliximab levels/antibodies before every infusion
15742493|NCT04921657|Drug|Rosuvastatin 10mg|
15742521|NCT04921410|Device|Sham Biofeedback|The biofeedback knee sleeve is a device that is artificially-intelligent and utilizes determined cut-off values of knee motion and forces to determine whether a motion is 'good' or 'bad'. This intervention will provide sham biofeedback during training sessions.
15742524|NCT04921371|Other|Colgate® Cavity Protection Toothpaste|Participants will use Colgate® Cavity protection toothpaste for brushing teeth twice daily.
15769160|NCT04702685|Drug|Ropivacaine|Local anesthetic for injection
15742494|NCT04921631|Behavioral|Early Integration of Specialty Palliative Care with Critical Care|The PC team will visit the patient within 24 hours of randomization and the consultation will address the following domains of PC: illness understanding and goals of care conversations with patients/surrogates; symptom assessment and management; spiritual needs; patient and family coping and support; and care coordination and transitions. The initial family meeting will be scheduled to occur within two days of randomization. Follow-up visits will be conducted by the PC MD/APP every weekday. During this time, the ICU and PC team will be in daily communication. The PC team will continue to follow the patient in the hospital once discharged from ICU. Prior to discharge, the PC team will document patient goals and preferences for future treatment, coordinate appropriate PC services in the home and/or outpatient clinic settings and contact the patient's primary physician to provide an update on the patient's hospital stay.
15742495|NCT04921618|Other|2 online self-administered questionnaires on|"Participant profile
~Spontaneous partner notification practices collected one month after STIs diagnosis"
15742496|NCT04921618|Other|2 online self-administered questionnaires on|"Participant profile
~Experiences with partner notification and use of STI testing following notification"
15742497|NCT04921605|Device|DragonFly transcatheter mitral valve clamping system|To conduct edge-to-edge repair with Dragonfly System under the guidance of transesophageal echocardiography.
15742498|NCT04921592|Other|upper extremity stimulation|transcutaneous stimulation of the upper extremities
15742499|NCT04921579|Procedure|En masse retraction|Retraction stated on a 0.017''x 0.025'' Stainless steel wire using elastomeric chain ( force applied 200 g per side) extending between the crimpable hooks and the mini-screw.
15742500|NCT04921579|Procedure|Two-Step retraction|Retraction of canine started on a 0.017''x0.025'' Stainless steel wire using elastomeric chain ( force applied 150 g per side) followed by anterior teeth retraction on 0.017''x0.025'' Stainless steel wire using elastomeric chain ( force applied 160 g per side) extending between crimpable hooks and the mini-screw.
15742501|NCT04921566|Drug|Torasemide tablet 10 mg|Torasemide is manufactured by Pharmtechnology LLC, Belarus. Each tablet contains 10 mg of torasemide.
15742502|NCT04921566|Drug|Toradiur® tablet 10 mg|Toradiur® is manufactured by MEDA Manufacturing Cologne, Germany. Each tablet contains 10 mg of torasemide.
15742503|NCT04921553|Other|Data collection and quality of life questionnaire|"Data collection from the medical file
~Quality of life questionnaire (QLQC30) at inclusion, at each change of treatment and then every 6 months"
15742504|NCT04921540|Procedure|Ingrown toenails with surgery with chemical cauterisation|Removal of the ingrown lateral part of the toenail and chemical cauterisation
15742505|NCT04921540|Procedure|Ingrown toenails with only surgery|Removal of the ingrown lateral part of the toenail with directed Healing pad
15742506|NCT04921527|Drug|chiauranib|50mg orally once daily
15742507|NCT04921527|Drug|Placebo|50mg orally once daily
15742508|NCT04921527|Drug|Paclitaxel|at the first cycle, 60mg/m2, i.v infusion on day 1, 8 and 15 ; at the begining of the second cycle, after a comprehensive assessment , investigators decide whether to increase the dosage to 80mg/m2, i.v infusion on day 1, 8 and 15 ;
15742509|NCT04921514|Behavioral|SASRQ questionnaire|"During an interview with a trained psychologist, the presence of acute stress will be assessed by the SASRQ test within one week of the occurrence of a sudden recovered death.
~The diagnosis of acute post-traumatic stress disorder is made according to the presence of at least three dissociative symptoms out of five, and other symptoms of re-experiencing, avoidance or marked anxiety or hypervigilance. Each symptom is thus evaluated dichotomously. A symptom is present if the intensity of the response is 3 or more (0 from 0 to 2 and 1 from 3 to 5)."
15742510|NCT04921514|Behavioral|PCL-5 with LEC-5 questionnaire|"This questionnaire will be completed during an interview with a psychologist trained in the protocol, 3 months after the sudden death.
~The PCL-5 is a 20-item self-report questionnaire that assesses the 20 symptoms of PTSD according to the DSM-V. It is associated with the LEC-5 questionnaire.
~The self-reported scale uses ratings of 0 to 4 to assess each of the symptoms.
~A threshold of 38 on the PCL-5 seems reasonable to suggest the presence of PTSD."
15742511|NCT04921501|Device|HD ECG|This experimental procedure is a passive, non-invasive, high-density surface ECG recording using 128 skin electrodes.The electrodes are positioned on strips of 10 electrodes to be prepared with adhesive tape and coated with conductive gel before installation on the patient. The total duration of the acquisition is 10 to 30 minutes.
15742512|NCT04921501|Device|Conventional 12-lead ECG|This standard 12-lead ECG is defined on the HD ECG, from electrodes F13, G3, G14, H5, H15, H25 corresponding to the precordial electrodes. 4 limb electrodes will be added for the frontal leads. Thus, the HD and 12-lead ECGs will be obtained simultaneously.
15742513|NCT04921488|Device|screening colonoscopy|The screening colonoscopy will be performed by an investigator. The automatic detection and characterization system will be activated at the time of descent of the colonoscopy (after caecal intubation), with video recording (image without CAD EYE and image with CAD EYE). The investigator performing the colonoscopy will be blinded by the results of the CAD EYE.
15742514|NCT04921475|Device|Regional oxygen saturation monitoring|Regional oxygen saturation of kidney is monitored using near infrared spectroscopy
15742515|NCT04921462|Procedure|Septoplasty surgery|septoplasty procedures were performed by a single surgeon using the same technique among all patients. The procedures were conducted under general anesthesia according to the standard preoperative care used in our institution.
15742516|NCT04921449|Other|ED Physical Therapy|All ED Physical Therapy treatment classifications involve a combination of exercise, range of motion, education, prognostic guidance, and reassurance. Patients are provided with an individualized home exercise plan based on their matched treatment classification and/or active rest.
15742517|NCT04921449|Other|Usual Care|Includes any diagnostic imaging, patient education and reassurance, and administration or prescribing of analgesic medications, as per the treating physician's usual and customary practice.
15742518|NCT04921436|Procedure|cardiac surgery|prophylactic use of antibiotic-inhibitors
15742519|NCT04921423|Behavioral|Situational simulation teaching|The intervention included communication theory and skills, aging trend and knowledge, teaching plans for elderly nursing, activities for the elderly and visual experience, application and debriefing of empathy.
15742525|NCT04921371|Other|Listerine® Cool Mint®|Participants will use 20 mL of Listerine® Cool Mint® mouth rinse for 30 seconds after brushing twice daily.
15743551|NCT04912570|Procedure|Standard PCI|Standard PCI according to the most recent guidelines
15742527|NCT04921371|Other|5% Hydroalcohol Mouthrinse|Participants will use 20 mL of 5% Hydroalcohol Mouthrinse for 30 seconds after brushing twice daily.
15742528|NCT04921371|Other|Mouthrinse Prototype 1|Participants will use 20 mL of Mouthrinse Prototype 1 for 30 seconds after brushing twice daily.
15742529|NCT04921371|Other|Mouthrinse Prototype 2|Participants will use 20 mL of Mouthrinse Prototype 2 for 30 seconds after brushing twice daily.
15742530|NCT04921358|Drug|Tislelizumab in combination with Sitravatinib|Tislelizumab 200 mg intravenously once every 3 weeks in combination with sitravatinib 100 mg orally once a day, A cycle is 21 days in length ± 3 days, to be administered until Progressive Disease or intolerable toxicity
15742531|NCT04921358|Drug|Docetaxel|Docetaxel 75 mg/m2 intravenously once every 3 weeks, A cycle is 21 days in length ± 3 days, to be administered until Progressive Disease or intolerable toxicity.
15742532|NCT04921345|Drug|Nemolizumab|Participants will receive subcutaneous (SC) injection of 10, 20 or 30 milligrams (mg) nemolizumab, every 4 weeks (Q4W) for 52 weeks with a loading dose of 20, 40 or 60 mg at Day 1 based on the body weight.
15742533|NCT04921332|Device|Bright Light Therapy (BLT) Lamp|With its built in automatic timer shut-off function, the bedside RN would not need to return to the room to turn off this lamp after 30 minutes because the lamp will automatically shut off on its own.
15742534|NCT04921319|Diagnostic Test|VExUS score|"The care team will be informed of the VExUS immediately after the ultrasound is performed and given a suggested target for the following 24 hours as follows:
~VExUS 0: The patient will likely tolerate more fluid if clinically needed.
~VExUS 1: The patient has evidence of mild venous congestion. The investigators recommend targeting a net neutral or negative fluid balance with diuresis.
~VExUS 2-3: The patient has evidence of moderate to severe venous congestion. The investigators recommend targeting a fluid balance of negative 1-2L with diuresis. If the investigator cannot obtain ultrasound images of sufficient quality to calculate VExUS, the care team will be informed that there is no recommendation for that subject on that day."
15742535|NCT04921306|Drug|Clenbuterol Hydrochloride|Daily ingestion of clenbuterol hydrochloride capsules (40 microgram/day) for a total period of 28 days with a wash-out period of at least 6-8 weeks.
15742536|NCT04921306|Drug|Placebo|Daily ingestion of placebo capsules for a total period of 28 days with a wash-out period of at least 6-8 weeks.
15742537|NCT04921293|Behavioral|Ketogenic diet|A diet with <50gr of carbohydrates per day. Monosaturated fats consumption will encourage over saturated fats
15742538|NCT04921293|Dietary Supplement|Exogenous ketones|Administration of ketone monoester 25 ml t.i.d
15742539|NCT04921293|Behavioral|Standard diet + placebo|A standard diet incorporating current recommendations (low in sodium and low in liquids) for heart failure patients.
15742540|NCT04921280|Behavioral|Internet based Cognitive Behavioural Therapy|"The treatment program consists of 12 chapters or modules spread over 12 weeks and contains written information, different exercises and weekly homework assignment. Patients get access to the CBT program via an internet portal and they have weekly contact with a licenced psychologist via encrypted email. Focus of the therapist support is to review the content of the weekly module, reinforce progress and engagement in therapy and assist with treatment difficulties. If needed, therapist can contact patients via telephone. Patients receive weekly reminders via SMS to login to the portal and fill out self-report measures."
15742541|NCT04921267|Behavioral|training|training with filtered speech
15742542|NCT04921254|Drug|BSG005 or placebo|"SAD part is a single IV infusion of ascending doses of BSG005 or placebo - a 30 minutes infusion that may be extended to 2 hours if infusion reactions occur.
~The MAD part is single daily infusions of the cohort dose over 30 minutes (that may be delayed up to 2 hours in case of infusion reactions) and which will be repeated daily for 7 days. Objective is safety, tolerability and PK on day 1 and day 7 and to establish steady state plasma level."
15742543|NCT04921228|Behavioral|Heart rate variability biofeedback|"5 days of 3-min HRV readings to establish baseline HRV
~After meeting with study personnel to review HRV biofeedback (BF) practice with the app, participants will be asked to begin HRV BF training for 5 min a day
~Participants will increase the length of HRV BF training by 5 min every few days until they reach 20 min a day of HRV BF training
~Participants will aim for 20 min of daily HRV BF training for 6 consecutive wks out of the 8-wk total BF training protocol
~Study personnel will follow the participants' progress with training via the online portal provided through the Optimal HRV app and have brief (15-min) check-in appts. with participants to discuss how they are experiencing HRV BF, what they find helpful, and barriers to their practice if they are having difficulties
~After completing the 8-wks of BF training (including 2 wks of 5-min titrations to the full 20-min protocol), participants will be asked to take 3-min HRV readings for 5 days to assess post-intervention HRV"
15742544|NCT04921215|Behavioral|Morning bright light|All participants will receive phase advancing morning bright light.
15742545|NCT04921202|Other|Metabolic syndrome and meniscus injuries|Metabolic syndrome
15742546|NCT04921189|Drug|The combined supplement of Ascorbic acid, Thiamine, and Cortisol|"The combined administration of 3 drugs will be mixed in a 50 mL 0.9% saline bag respectively and administered through intravenous infusion over 60 min every 12 h for 3 days.
~Ascorbic acid (Ascorbic acid Inj [500mg]®): 50 mg/kg, maximum single dose 3 g, daily dose 6 g
~Thiamine (Thiamine hcl inj [50mg]®): 200 mg
~Cortisol (Cortisolu inj [100mg]®): 100mg"
15742547|NCT04921189|Drug|Placebo|An identical volume of 0.9% saline (150mL) administered through intravenous infusion over 60 min every 12 h for 3 days.
15742548|NCT04921163|Dietary Supplement|sodium aluminium phospate (SALP)|1 pancake daily for 4 days
15742549|NCT04921163|Dietary Supplement|Aluminium-free pancake|1 pancake daily for 4 days, without aluminium
15742550|NCT04921150|Other|standardization management|Apply standardization management to improve the outcomes of pregnancy
15742551|NCT04921137|Other|No endocrine therapy|No endocrine therapy given
15742552|NCT04921137|Other|Endocrine therapy|Endocrine therapy given for at least 5 years
15742553|NCT04921124|Drug|Teriparatide|PTH(1-34) cartridge and pen device
15742554|NCT04921111|Drug|SCT1000|Recombinant 14 valent human papillomavirus vaccine (6,11,16,18,31,33,35,39,45,51,52,56,58,59) (insect cells)
15742555|NCT04921111|Drug|Gardasil®9|Recombinant 9 or 4 valent human papillomavirus vaccine
15742556|NCT04921111|Drug|placebo|aluminium phosphate
15742557|NCT04921111|Drug|Gardasil®|Recombinant 4 valent human papillomavirus vaccine
15742558|NCT04921098|Procedure|Diode Laser Cyclophotocoagulation|A handpiece (G probe) is used to deliver the diode laser energy with a wavelength of 810 nm.
15742560|NCT04921072|Behavioral|Constant practice conditions|CG will be practicing only one specific pattern of step isometric contractions (SPSIC) scheme. It means that 90 trials in all training sessions will consist only of SPSIC 1.
15742561|NCT04921072|Behavioral|Variable practice conditions|VG will practice three SPSIC's (1-3). Each SPSIC will be practiced 30 times per session in a random order, which means that each session will consist of 90 SPSIC like CG.
15742562|NCT04921059|Diagnostic Test|Active Stand|The participant is asked to lie down for 10 mins without moving or speaking. A heart rate monitor is attached while the participant is lying down. They are then asked to stand up as quickly as possible and to remain standing unassisted for 3 minutes. The participant will be asked to describe any symptoms at 1 and 3 minutes after standing. Blood pressure and heart rate will be monitored constantly throughout the test.
15742563|NCT04921046|Drug|lignocaine|After giving lignocaine to a group of people, myoclonus was observed after the dose of etomidate given two minutes after lignocaine.
15742564|NCT04921046|Drug|Midazolam 1 milligram Prefilled Syringe|after giving midazolam to the second group of people two minutes before etomidate dose, myoclonus was observed for one minute.
15742565|NCT04921033|Dietary Supplement|EEN (Nestle Modulen®)|35kcal/kg/day for every patient
15742566|NCT04921033|Drug|Standart of care|"Budesonide 9mg/day for mild disease
~Prednisolone 1mg/kg, maximum 40mg/day in decreasing doses (40mg for 4 weeks followed by a fixed taper for 6 weeks) for moderate-to-severe disease for 12 weeks.
~Patients with moderate to severe disease in the steroid group will also receive 2mg/kg azathioprine. The dose of azathioprine will be adjusted according to abnormalities of white blood cell (WBC) count, platelet count, liver function tests (LFTs; i.e. alanine transaminase [ALT], aspartate transaminase [AST], alkaline phosphatase), lipase, blood urea nitrogen (BUN), and serum creatinine."
15742567|NCT04921020|Other|Photography|Facial photographs and blinking videos are taken
15742568|NCT04921007|Procedure|Sacral ESP block|A high-frequency ultrasound linear probe covered with a sterile sheath will be placed longitudinally to the midline of the sacrum. The median sacral crests and erector spinae muscle will be visualized, then a 22-gauge, 50 mm needle will be advanced from cranial to caudal direction until its tip touch the sacral crest.
15742569|NCT04921007|Procedure|Caudal block|A high-frequency ultrasound linear probe covered with a sterile sheath will be placed on to the sacrococcygeal region. The dura mater, epidural space, conus medullaris, sacral cornua, and sacrococcygeal ligament will be identified. Using the in-plane technique, a 22-gauge, 50 mm needle will be introduced to reach the sacral epidural space.
15742570|NCT04921007|Drug|Bupivacaine Hydrochloride|Following negative aspiration, a precalculated dose (0.5 ml/kg) of 0.25% bupivacaine will be injected.
15742571|NCT04920994|Procedure|M-TAPA block|A high-frequency linear ultrasound probe will be used, probe will be placed on the costochondral angle in the sagittal plane and angled deeply to view the lower aspect of the chondrium in the midline, then using in-plane approach, a 22 Gauge Tuohy needle will be introduced into the lower aspect of the chondrium. The same procedure will be repeated on the contralateral side.
15742572|NCT04920994|Procedure|SCTAP block|A high-frequency linear ultrasound probe will be placed obliquely on the upper abdominal wall, along the subcostal margin near the midline. After identifying the rectus abdominis muscle, the ultrasound probe will be gradually moved laterally along the subcostal margin until the transversus abdominis muscle will be identified lying posterior to the rectus muscle, then using in-plane approach, a 22 Gauge Tuohy needle will be introduced medially and directed towards the transversus abdominis plane until its tip reaches the fascia between the rectus abdominis and the transverse abdominis muscles on entering the neurofascial plane. The same procedure will be repeated on the contralateral side.
15742573|NCT04920994|Drug|Bupivacaine Hydrochloride|20 ml 0.25% bupivacaine will be injected after the negative aspiration test.
15742574|NCT04920981|Other|atezolizumab|observational
15742575|NCT04920968|Drug|Obinutuzumab|Chemotherapy will be conducted according to PALG ALL7 protocol, which is considered a standard of care in Poland. Patients in experimental arm will receive obinutuzumab .Obinutuzumab: 1000 mg i.v. (first infusion divided into 100 mg on d. 1 and 900 mg on d. 2).
15742576|NCT04920968|Drug|Rituximab|Chemotherapy will be conducted according to PALG ALL7 protocol, which is considered a standard of care in Poland.The protocol includes the use of rituximab in combination chemotherapy. Rituximab: 375 mg/m2 intravenously (i.v.)
15742577|NCT04920942|Drug|Ivermectin 0.4mg/kg/day for 5 days|Ivermectin 0.4mg/kg/day for 5 days with standard-of-care
15742578|NCT04920929|Device|Hydrophilic Biomaterial|PICC made out of a Hydrophilic Biomaterial
15742579|NCT04920929|Device|Thermoplastic Polyurethane|PICC made out of a thermoplastic polyurethane material
15742580|NCT04920916|Biological|Dupilumab|Participants will receive a loading dose of dupilumab (600 mg, given as two 300 mg subcutaneous injections) on day 0/1. If participants are still hospitalized a second and third dose (300 mg) will be given on days 14 and 28.
15742581|NCT04920916|Drug|Placebo|Participants will receive a loading dose of normal saline (2 ml, given as two one ml subcutaneous injections) on day 0/1. If participants are still hospitalized a second and third dose (1 ml) will be given on days 14 and 28.
15742582|NCT04920903|Drug|COR588|Increasing doses of COR588 will be administered for cohorts 1-4 in the single ascending dose phase and for cohorts 1-4 in the multiple ascending dose phase.
15742583|NCT04920903|Drug|Placebo|Placebo will be administered for cohorts 1-4 in the single ascending dose phase and for cohorts 1-4 in the multiple ascending dose phase.
15742584|NCT04920890|Device|Radiofrequency therapy|Monopolar Capacitive Resistive Radio Frequency at 448 kHz (INDIBA®) (RFMCR).
15742585|NCT04920890|Device|Placebo without radiofrequency.|The device will be used without turning on the patient, thus administering a placebo treatment.
15742586|NCT04920877|Other|Infection Prevention|Preventing central catheter-related bloodstream infections in intensive care units
15742587|NCT04920864|Device|rTMS|Repetitive transcranial magnetic stimulation
15742588|NCT04920851|Device|cytokine hemadsorption|to compare the laboratory and clinical results of cytokine hemadsorption as an immunomodulation therapy in COVID-19 ICU patients with or without sepsis.
15742589|NCT04920838|Drug|Nitazoxanide and Ciclésonide|Inhaled Ciclésonide: 320 mcg BID per day and Oral Nitazoxanide:2000 mg tablets daily (divided into two daily intakes of two tablets of nitazoxanide 500 mg) during 14 days.
15742590|NCT04920838|Drug|Telmisartan 20Mg Oral Tablet|20 mg tablet daily
15771070|NCT04686825|Drug|DA-8010 5mg (Fed)|Test drug lV : DA-8010 5mg (Fed)
15742591|NCT04920838|Drug|Paracetamol|"Tablets containing 500 mg of paracetamol. One to two tablets every 4-6 hours as required, to a maximum of 6 tablets (3 grams) daily in divided doses.
~Duration of treatment: up to 14 days"
15742592|NCT04920825|Dietary Supplement|Sacha Inchi Oil softgel supplement|A twice daily supplementation of Sacha Inchi Oil softgel for 12 weeks
15742593|NCT04920825|Dietary Supplement|Corn oil softgel|A twice daily supplementation of Corn Oil softgel for 12 weeks (Placebo)
15742594|NCT04920812|Genetic|diagnosis of mitochondrial myopathy|• Determination of the presence of specific molecular signatures at the RNA level in muscles and fibroblasts from patients
15742595|NCT04920799|Dietary Supplement|Nitrate rich beetroot juice|Participants will drink nitrate rich beetroot juice (2.4 floz ; Beet It Sport Nitrate 400 concentrated beetroot shot; James White Drink, ltd) twice daily for two weeks.
15742596|NCT04920799|Dietary Supplement|Nitrate depleted beetroot juice|Participants will drink nitrate depleted beetroot juice (2.4 floz ; Beet It placebo concentrated beetroot shot; James White Drink, ltd) twice daily for two weeks.
15742597|NCT04920786|Drug|TB006|TB006
15742598|NCT04920786|Other|Sterile saline (Placebo)|Sterile saline
15742599|NCT04920773|Other|Guduchi Ghanvati|500 mg of Samshamani vati or Giloy Ghanavati (Aqueous extract of Tinospora cordifolia) twice daily
15742600|NCT04920773|Other|Standard guidelines|Practice guidelines to follow physical distancing, respiratory and hand hygiene, wear mask
15742601|NCT04920760|Dietary Supplement|Vitamin A supplement|The supplementation protocol will be the additional care established by World Health Organization (WHO) and the United Nations International Children ʹs Fund (UNICEF) for measles (1998)(i.e. of 200,000 IU, or 50,000-100,000 IU for children > 1 or for infants of < 1 year of age, respectively).
15742602|NCT04920747|Drug|Taxane|docetaxel or paclitaxel
15742603|NCT04920721|Other|no intervention|no intervention descriptiv study
15742604|NCT04920708|Drug|Ipatasertib 300mg|Ipatasertib 300mg once daily. Oral administration. Treatment is continuous daily for 21 days, followed by 7 days off, to complete a 28 day cycle.
15742605|NCT04920708|Drug|Fulvestrant 500g|Fulvestrant 500mg administered intramuscularly in the buttocks slowly (1-2 minutes per injection) as two 5-mL injections (one in each buttock). Administered days 1 and 15 of Cycle 1. For subsequent cycles, patients will receive fulvestrant as described above in the clinic on Day 1 of each cycle or approximately every 4 weeks.
15742606|NCT04920708|Drug|Palbociclib 75mg-125mg|Palboclicib 75mg-125mg once daily, dependent on toxicities. Oral administration. Treatment is continuous daily for 21 days, followed by 7 days off, to complete a 28 day cycle.
15742607|NCT04920708|Drug|CDK4/6 Inhibitor|CDK4/6 inhibitor. As per current standard of care regime for ER+/HER2- breast cancer.
15742608|NCT04920695|Drug|Nitric Oxide|Pulmonary vasodilator (gas).
15742609|NCT04920695|Drug|Placebo|medical grade normoxic gas (FiO2 = 0.21)
15742610|NCT04920682|Drug|Reversal of moderate neuromuscular blockade|Neostigmine 60 mcg/kg when TOF (Train-of-Four) = 3 and saline when TOF (T4 / T1)> 0.4
15742611|NCT04920682|Drug|Reversal of superficial neuromuscular blockade|Neostigmine 30 mcg/kg when TOF (T4 / T1)> 0.4
15742612|NCT04920682|Drug|Two-step reversal|Neostigmine 30 mcg/kg when TOF = 3 and neostigmine 30 mcg/kg when TOF (T4 / T1)> 0.4
15742613|NCT04920682|Drug|Placebo|0.9% saline solution (SF) when TOF = 3 and when TOF (T4 / T1)> 0.4
15742614|NCT04920669|Procedure|erector spinae block with bupivacaine|Patients will receive a sonar-guided erector spinae plane block with 20 ml of bupivacaine 0.5%
15742615|NCT04920669|Procedure|erector spinae block with bupivacaine + dexmedetomidine|Patients will receive a sonar-guided erector spinae plane block with 19 ml of bupivacaine 0.5%+ 1 ml dexmedetomidine
15742617|NCT04920630|Behavioral|Cognitive Behavioral Therapy - Insomnia (CBT-I)|CBT-I will be delivered via 5 weekly virtual group therapy sessions. Session content is manualized and adapted from existing CBT-I protocols to be relevant to a virtual adolescent group and will include: Session 1 - Introduction of group members, group rules, psychoeducation regarding sleep, and instructions on completion of sleep log. Session 2 - Review sleep log, sleep hygiene, relaxation training, and stimulus control. Session 3 - Review sleep log, sleep restriction, and cognitive strategies (positive self-statements, worry management). Session 4 - Review sleep log and sleep restriction, and problem-solving barriers. Session 5 - Maintenance and relapse prevention.
15742621|NCT04920604|Other|Face-to-face anesthesia consultation|The anesthesia consultation is carried out in person in accordance with the usual management.
15742622|NCT04920604|Other|Remote anesthesia consultation|"Anesthesia consultation is carried out in teleconsultation via the Téléo web application (audio and video) at the patient's home on a computer or smartphone. This application allows sending and receiving documents identical to those during the face-to-face consultation."
15742623|NCT04920591|Other|doll treatment|"The doll used in the study is the empathy doll; these dolls are designed to obtain an optimal interaction with patients and to arouse empathy."
15742626|NCT04920565|Device|hemoperfusion with polymyxin B|polymyxin B is covalently immobilized on polystyrene strands, selectively removes endotoxin and at the same time there is no leaching of the ligand, immobilization is carried out by electrostatic interaction and Vanderwals force
15742627|NCT04920552|Device|Elastic abdominal binder|"The ABDO-SYNCRO 3-BAHNIG is an elastic abdominal binder with a 3-stripes Velcro fastening, capable of developing a 20 ± 2 mmHg pressure on the abdominal wall. This device will be tested as potentially beneficial with respect to the mentioned primary and secondary outcomes. The investigators anticipate to use this elastic abdominal binder, since participants of a previous trial reported this device to be comfortable enough and to have used it regularly during the open-label follow-up phase. Size will be chosen depending on the abdominal circumference of the participant, according to the size tables provided from the manufacturer (SYNCRO-MED GmbH)."
15742628|NCT04920552|Device|Placebo binder|"Clima Care is a simple body warmer, developing maximal 3±2 mmHg pressure on the abdominal wall. This device will be used as placebo comparator of the present clinical trial. Size will be chosen depending on the abdominal circumference of the participant, according to the size tables provided from the manufacturer."
15742629|NCT04920539|Drug|Active Delta-9-THC|Active Delta-9-THC (0.03 mg/kg) administered intravenously.
15742630|NCT04920539|Drug|Placebo|Placebo (saline solution) administered intravenously.
15742631|NCT04920526|Drug|Quadrivalent HPV [Type 6, 11, 16 and 18] L1 Virus-Like Particle Vaccine|No intervention will be administered
15742632|NCT04920500|Drug|Daunorubicin Cytarabine liposome for injection|Induction 1: [100 U/m²] i.v. d1,3,5 Induction 2: [100 U/m²] i.v. d1,3
15742633|NCT04920500|Drug|Vyxeos、Daunorubicin Cytarabine liposome for injection|Induction 1: [100 U/m²] i.v. Vyxeos（d1）,Daunorubicin Cytarabine liposome for injection（d3、d5） Induction 2: [100 U/m²] i.v. Daunorubicin Cytarabine liposome for injection（d1、d3 ）
15742634|NCT04920461|Device|Additional MRI sequences|Additional MRI sequences (3D T2 SPACE sequence, 4/5 minutes approximatively)
15742635|NCT04920461|Other|Neuropsychological assessment|Neurovisual function assessed with neuropsychological tests
15742636|NCT04920448|Drug|N-Acetyl cysteine|Administered as specified in the treatment arm
15742637|NCT04920422|Other|No intervention|Retrospective analysis using database without any intervention assigned in the study.
15742638|NCT04920409|Other|FAWGT diet|Composed of 15% protein, 55% CH and 30% fat of which < 10% was SFA, 14% MUFA and 6% PUFA in the overall total caloric content.
15742639|NCT04920409|Other|Usual diet (UD)|Consisted of 16% protein, 54% carbohydrates (CH) and 30% fat of which 15% was saturated fat (SFA), 10% monounsaturated fat (MUFA) and 5% polyunsaturated fat (PUFA)in relation to the total caloric content
15742640|NCT04920396|Device|E>Eye IRPL|Regulated intense pulsed light therapy
15742641|NCT04920396|Device|Warm compress|Fabric mask with anti-bacterial coating filled with BodyBeads® heated in a microwave for 30 seconds before application over the eyes for 5 minutes
15742644|NCT04920370|Drug|ALXN1720 SC|ALXN1720 will be administered via SC route.
15742645|NCT04920370|Drug|ALXN1720 IV|ALXN1720 will be administered via IV route.
15742646|NCT04920370|Drug|rHuPH20|rHuPH20 will be administered via SC route.
15742647|NCT04920370|Drug|Placebo SC|Placebo will be administered via SC route.
15742648|NCT04920370|Drug|Placebo IV|Placebo will be administered via IV route.
15742649|NCT04920357|Drug|Vaccination|Persons that are vaccinated within the national and regional vaccine program are invited to participate in the follow-up study.
15742650|NCT04920344|Procedure|Transoral Surgery|Patients will undergo transoral surgery
15742651|NCT04920344|Radiation|External Beam Radiation Therapy|Patients in Group II and Group III will undergo External Beam Radiation Therapy (EBRT) RT following transoral surgery.
15742652|NCT04920344|Drug|Cisplatin|Patients in Group III will receive cisplatin, 30 mg/m2, administered intravenously weekly per for 6 weeks.
15742653|NCT04920344|Procedure|Incisional Tumor Biopsy|Incisional biopsy of the primary tumor site will be required to confirm p16/HPV status of the tumor
15742654|NCT04920344|Other|Circulating tumor deoxyribonucleic acid (ctDNA) levels assessment|Assess ctDNA levels at baseline, 2 weeks, 4 weeks, 10 weeks, 24 weeks and 1 year after the surgery.
15742655|NCT04920344|Other|MD Anderson Dysphagia Index|MDADI is a 20 item quality of life questionnaire specifically focusing on swallowing aspects. It was originally designed for head and neck cancer patients. The total score ranges from 20 to 100 with the higher score indicating higher level of function.
15742656|NCT04920344|Other|University of Washington Quality of Life Questionnaire|University of Washington Questionnaire is a 15 item quality of life instrument specifically designed for head and neck cancer patients.
15742657|NCT04920344|Other|Euro-QOL 5 dimension scale questionnaire|A generic quality of life and cost utility instrument widely used and validated for multiple disease settings, including head and neck cancer.
15742658|NCT04920344|Diagnostic Test|Modified barium swallow (MBS) evaluation with aspiration-penetration scale|"The videofluoroscopic modified barium swallow (MBS) study is the gold standard for for the evaluation of dysphagia, and specifically, airway protective mechanisms.
~The penetration/aspiration (PEN/ASP) scale is a routinely used eight-point scale designed to describe the depth of bolus penetration into the airway and the patient response to the penetration or aspiration."
15742659|NCT04920331|Biological|Erenumab|140mg single intravenous administration (60 minutes)
15742660|NCT04920318|Combination Product|tDCS + language therapy|In this study fMRI-guided noninvasive neuromodulation will be applied, called Transcranial Direct Current Stimulation (tDCS) to the frontal and parietal brain regions that show reduced activation but still are structurally intact. TDCS will be paired with personalized speech-language therapy to enhance language functions.
15742661|NCT04920318|Combination Product|sham TDCS + language therapy|sham control will be applied with language therapy to the same regions as active TDCS.
15742662|NCT04920305|Dietary Supplement|Phosphatidylserine|subjects in the treatment group oral the PS (600mg/d, q.d.) for 6 months.
15742663|NCT04920305|Dietary Supplement|Bean powder|Subjects in the control group were given a placebo, which was the same shape of bean powder(600mg/d, q.d.).
15742666|NCT04920266|Device|Smart Cap, running and fitness exercisers only|Bottle cap
15742667|NCT04920266|Device|Sweat Patch, all subjects- running, fitness, cycling|Regional contralateral forearm patch
15742668|NCT04920266|Device|Reference sweat patch, all subjects - running, fitness, cycling|Regional contralateral forearm patch
15742669|NCT04920266|Other|Bottle Scale, all subjects - running, fitness, cycling|Bottle weight
15742670|NCT04920253|Device|Study Device Debridement|debritom+ water jet debridement
15742671|NCT04920253|Device|SOC Debridement|Sharp Scalpel
15742782|NCT04919239|Biological|RUTI®|Participants randomised to this arm will receive one single dose of RUTI® vaccine in the right/left deltoid muscle.
15771198|NCT04685616|Drug|Haematopoietic growth factor|See arm description
15742672|NCT04920240|Behavioral|cleaning and disinfection mode for surfaces with high frequency contact|According to the results of the survey on the status of high frequency contact surface, the corresponding frequency and method of cleaning and disinfection are determined. Set up a multidisciplinary quality control team.
15742673|NCT04920240|Behavioral|Routine procedure|clean the high frequency contact surface like other surfaces
15742674|NCT04920227|Procedure|phacoemulsification;|Group A: class combined with phacoemulsification
15742675|NCT04920214|Diagnostic Test|SonoVue|CEUS examination was performed and corresponding image information of liver lesions was obtained.
15742676|NCT04920201|Other|Over-ground walking without GEMS-H|Over-ground walking without GEMS-H (30 min per session, at least 3 times per weeks, total 10 sessions)
15742677|NCT04920201|Device|Over-ground walking with GEMS-H with resist mode|Over-ground walking with GEMS-H with resist mode (30 min per session, at least 3 times per weeks, total 10 sessions)
15742678|NCT04920201|Device|Stair ascent with GEMS-H with assist mode|Stair ascent with GEMS-H with assist mode (30 min per session, at least 3 times per weeks, total 10 sessions)
15742679|NCT04920201|Device|Incline walking with GEMS-H with assist mode|Incline walking with GEMS-H with assist mode (30 min per session, at least 3 times per weeks, total 10 sessions)
15742680|NCT04920175|Other|Novel Real-time Neonatal Sleep Stage Detection Algorithm|Comparison of Novel Real-time Neonatal Sleep Stage Detection Algorithm to gold standard concurrent polysomnogram.
15742681|NCT04920162|Other|Biospecimen into patients who had skin diseases|Collect of blood samples without DNA into patients who had a vitiligo or a melanoma at day 0 until 1 year after their treatment
15742682|NCT04920149|Drug|Mesalamine|The IMP will be supplied as sachets with slow-releasing granules.
15742683|NCT04920149|Drug|Placebo|The IMP will be supplied as sachets with slow-releasing granules.
15742686|NCT04920123|Device|Neuro-World|Neuro-World is a collection of six games that are developed for cognitive training that focuses on memory and attention.
15742687|NCT04920097|Device|Virtual Auricular Point Acupressure (APA)|Participants will learn how to self-administer APA by themselves.
15742688|NCT04920097|Other|In-Person Training|Participants will receive in-person training to self-administer APA.
15742689|NCT04920097|Other|Usual Care|Participants will continue to do whatever they are receiving from their oncologist.
15742690|NCT04920084|Other|Plant based meals|For 12 weeks, patients will receive two premade meals per day, for lunch and dinner, prepared and shipped weekly by U.S.-based WFPBD company Plantable. The meals will have a low glycemic index and contain vegetables, whole grains, and plant-based fats that have undergone minimal processing. Instructions will be provided for food storage and reheating. Detailed recommendations for snacks and breakfasts meeting the standard of a WFPBD will also be given to supplement their daily calorie needs with access to an online portal from Plantable which contains education materials and access to a coach daily for 24 weeks.
15742691|NCT04920071|Device|Visual acuity and contrast sensitivity measurement|Those subjects who meet the inclusion criteria will undergo the study tests. These measurements will be performed on one eye only. Visual acuity will be quantified using two forms of the MAC chart (MAC 1 and 2) and two forms of a conventional letter design chart (C1 and 2). Contrast sensitivity will be measured using the two forms of the Pelli-Robson chart (CS1 and CS2). The order with which the test charts will be presented, in addition to the charts used (i.e. MAC 1 or 2, C1 or 2, and CS1 or 2), will be selected at random. Finally, a measurement of eye length will be collected using an IOL Master (Carl-Zeiss Meditec, USA).
15742692|NCT04920058|Device|Continuous Glucose Monitor|Continuous glucose monitor - a device that monitors blood glucose levels in a continuous closed-loop manner. This can also refer to the process of continuous glucose monitoring
15742693|NCT04920058|Other|<Active Comparator?>|<describe, Comprehensive Wellness Program incorporating a low carbohydrate diet (<50g/day) and associated education >
15742694|NCT04920045|Other|Red blood cell transfusion|All RBC transfusions will be administered in 1 unit increments to maintain patients' Hb concentration above the trial arm threshold they are randomized to. All transfusions will be followed by a Hb measure and an additional unit(s) of RBC's will only be transfused if there is documentation of the patient's Hb concentration below the trial arm threshold they are randomized to. However, in the case of life-threatening bleeding clinicians will be able to transfuse patients without first checking a patient's Hb concentration. Once randomized, patients will be man-aged according to protocol until hospital discharge independent of transfer to another service and/or specialized hospital ward.
15742695|NCT04920032|Drug|TAS-102|Given PO
15742696|NCT04920032|Drug|Irinotecan|Given IV
15742697|NCT04920032|Combination Product|Standard Treatment|6 cycles for a 2-week regimen (infusional 5FU based) and up to 4 cycles for a 3-week regimen (oral capecitabine based) after randomization
15742698|NCT04920032|Diagnostic Test|Signatera MRD ctDNA Assay|To be performed within 6-8 weeks of Cycle 1 Day 1. A Mid-treatment ctDNA is to be completed within 6 - 8 weeks of starting treatment. ctDNA is to also be completed within four weeks after completion of study treatment (+/- two weeks)
15742783|NCT04919239|Biological|Placebo|Participants randomised to this arm will receive aone single dose of matching RUTI® placebo in the right / left deltoid muscle.
15742784|NCT04919226|Drug|177Lu-Edotreotide (Peptide Receptor Radionuclide Therapy) PRRT|Peptide Receptor Radionuclide Therapy (PRRT) using 177Lu-edotreotide with a defined number of cycles will be administered.
15742699|NCT04920019|Procedure|Thoracic continuous epidural analgesia|"Continuous epidural catheter (Portex ™, Epidural Minipack , Smiths Medical), infused with 0.0625% bupivacaine (Marcaine™, Aspen Holdings) with morphine (morphine M&H™) 0.02 mg/ml 5 ml/h postoperative until POD3 morning Connected with The Sapphire ™ Infusion System Patient-Controlled-Analgesia (PCA) pump(fentanyl (fentanyl-Hameln™, Siam Bioscience): intravenous bolus mode only 15 ug/bolus, lockout interval 5 minutes, 4-hour limit 200 ug)
~Postoprative analgesia: intravenous paracetamol (infulgan ™, Yuria-Pharm), tablet paracetamol (SaRa ™), Parecoxib (Dynastat ™, Pfizer), Etoricoxib (Arcoxia ™, MSD)"
15742700|NCT04920006|Behavioral|Enhancing Active Caregiver Training|The intervention has three components within each session. Step 1, View, involves group viewing of a caregiving scenario, developed during previous research, which portrays a situation in which a caregiver is dealing with a challenging behavioral symptom. Step 2, Practice, involves small-group rehearsal activities that facilitate understanding, making choices, and examining possible responses. Step 3, Reflect, involves self-reflection and group processing surrounding choices and observations.
15742702|NCT04919980|Device|Innovalve MR system|Innovalve MR system
15742703|NCT04919967|Behavioral|Virtual implementation protocol|Participants assigned to the virtual implementation protocol plus e-learning/toolkit group will take the e-learning course and also receive additional assistance through Virtual Implementation support. The Virtual Implementation strategy will be provided through virtual assistance, training, and toolkits to help obstetric practices integrate perinatal mental health and obstetric care and is delivered over 2-3 months and includes two 1-hour virtual implementation e-meetings. Implementation will occur within the practice where a champion is identified who establishes a quality improvement team to implement the practice's change plan to achieve their goals of addressing perinatal mental health conditions.
15742704|NCT04919967|Behavioral|e-learning toolkit|A toolkit given to obstetric care providers to enhance knowledge about and screening for perinatal mood and anxiety disorders. Participants assigned to the e-learning/toolkit alone group will take an e-learning course.This four-part online learning course aims to help obstetric care practitioners address perinatal mental health conditions such as depression, anxiety, PTSD and bipolar disorder.
15742705|NCT04919954|Drug|Tebipenem Pivoxil Hydrobromide|Tebipenem 300 mg or 600 mg will be administered orally every 8 hours for total of 3 to 7 doses
15742706|NCT04919941|Other|A Guide to Conservative Care|The intervention is receipt of a patient decision aid on conservative care, entitled A Guide to Conservative Care. This is 12-page printed handout that provides an overview of conservative care. Participants assigned to the intervention group are mailed a copy of the Guide after their initial baseline visit (T1). Participants keep the Guide throughout the duration of the study.
15742707|NCT04919928|Device|Cochlear Implant and Hearing aid in bimodal solution|"Sixty adult participants with bilateral hearing aids (HA) referred for cochlear implantation (CI) will be included in the study. It will be patients who report limited benefit with appropriately fitted HAs in daily speech communication in quiet and in noise. The patients are depending on visual cues for successful communication.
~All the referred patients have potential optimal fitted HAs that are no longer sufficient to treat their hearing loss and to improve the daily communication. All the patients will then receive new replacement HAs with the ability to corporate with a CI for one month trial period. One month is considered as a sufficient adaptation period to new replacement HAs according to current clinical practice.
~Thirty individuals randomised to receive the intervention with CI to the poorest hearing ear."
15742708|NCT04919928|Device|Bilateral hearing aids|Thirty individuals randomised to the control group will continue use of the new replacement HAs another three months, thus in total of four months of use.
15742709|NCT04919915|Device|HEPA air cleaner|Participants in the intervention group received two HEPA air cleaners per household. They were informed to place the HEPA air cleaners in the child's bedroom and the living room. Field staff provided and discuss how to use the air cleaner which promoted continuous operation of both air cleaners, keeping the child's bedroom door closed, and selected the highest fan speed. Typical use of the HEPA cleaners were questioned during the mid-study and final visits.
15742710|NCT04919902|Procedure|Electric cardioversion|Electric cardioversion in short sedation according to established clinical practice and indications
15742711|NCT04919889|Other|Exercise prescription|All individuals referred to the community-based Exercise on Prescription program
15742712|NCT04919876|Dietary Supplement|fruit/vegetable supplement (FVS)|The supplement contains polyphenols, carotenoids, and other phytochemicals present in plant foods.
15742713|NCT04919876|Dietary Supplement|Placebo|The product does not contain nutrients present in the FVS.
15742714|NCT04919863|Drug|NTP42:KVA4|Single ascending dose (SAD) or multiple ascending dose (MAD) of NTP42:KVA4 administered to healthy volunteers as an oral suspension.
15742715|NCT04919863|Drug|Placebo|Placebo, matched to corresponding doses of NTP42:KVA4 administered to healthy volunteers as an oral solution.
15742716|NCT04919850|Dietary Supplement|Saccharomyces boulardii and SOD|A complex of 250 mg of Saccharomyces boulardii and 500 IU SOD to be assumed twice/day for 8 weeks at mealtimes
15742717|NCT04919850|Combination Product|Placebo|A placebo consisting of capsules containing the same excipients except the active compounds, and the same coating
15742718|NCT04919837|Other|Low vision aids|the assisting devices fitting for low-vision patients
15742719|NCT04919824|Procedure|Endoscopic Submucosal Dissection|Endoscopic submucosal dissection (ESD) is a novel technique for the removal of advanced colonic polyps with high-risk features. ESD is minimally invasive and allows the removal of colonic adenomatous polyp without resorting to surgery. The process of ESD includes marking the lesions selected for removal, followed by submucosal injection of a lifting agent, then circumferential incisions using a specialized knife followed by submucosal dissection of the entire lesion.
15742720|NCT04919824|Procedure|Endoscopic Mucosal Resection|Endoscopic mucosal resection (EMR) is a conventional endoscopic technique commonly used for the resection of superficial neoplastic lesions in the GI tract. EMR carries lower morbidity and mortality compared to surgery.
15742721|NCT04919811|Drug|Taletrectinib|600mg QD
15742722|NCT04919798|Device|Non-invasive bladder emptying device|The NIBED is applied to the penis during urination to support bladder emptying in urinary retention patients. It is a battery-driven handheld device that is operated by the patient himself.
15742833|NCT04918706|Drug|Placebo|The placebo will be an equivalent volume NaCl 0,9% and DMSO 5%
15742723|NCT04919785|Device|Deep brain stimulation|Stereotactic functional neurosurgery was first developed in 1947 and is today an established treatment for movement disorders. The surgical procedure is initiated by mounting a stereotactic frame on the head of the patient and a magnetic resonance image (MRI) is performed. Using a computerized navigational system the target structure is identified on the MRI and a trajectory chosen. In the operating theatre a burrhole is made on each side of the midline for the implantation of two electrodes. The electrodes are about 1.3 mm in diameter with several contacts at their distal end. An extension cable is tunneled under the skin, connecting the electrodes with a neuropacemaker placed below the clavicle in a subcutaneous pocket. The hospitalization time after surgery is dependent on the time needed for programming of the device, but the patients can usually return home within 3-5 days.
15742724|NCT04919772|Other|Assessment|The participants walk 4-meter and 10-meter and 5-repetition sit-to-stand twice.
15742725|NCT04919759|Behavioral|R-Basic|Participants in the R-Basic arm received access to a static website that contained educational materials on healthier eating and physical activity and the study questionnaires. The R-Basic intervention was implemented in the University of Sharjah.
15742726|NCT04919759|Behavioral|R-Enhanced|The R-Enhanced intervention was guided by the Social Cognitive Theory and employed a variety of behavior modification strategies, including self-monitoring, goal setting, self-efficacy, and social support to facilitate changes in diet and physical activity. In addition, participants in the R-Enhanced intervention had online access to a nutritionist. The R-Enhanced intervention was implemented in the United Arab Emirates University.
15742727|NCT04919746|Other|Systemic acupuncture|Systemic acupuncture will be performed on the lower limb, bilaterally, at points E36 (Zusanli) and BP6 (Sanyinjiao). Point location specificity will be determined using the anatomical and directional F-cun reference method. Stimulation of pre-defined points will be performed using needles with a threadlike, sterile, disposable character and size 0.25 x 30.0 mm, within a period of 20 minutes. The insertion of the needle will be at a depth of 0.5 inches, aiming to obtain the De Qi, sensation of energy at the point and in the corresponding meridian, referring to the effectiveness of systemic acupuncture.
15742728|NCT04919733|Device|Fluoroscopy reduction|To decrease, using 3-D mapping systems, the amount of fluoroscopy needed to implant a CIED
15742729|NCT04919720|Behavioral|FRAM Model and Human Factors/Quality Improvement Intervention|The group will use semi-structured interviews and ethnographic observations to inform development of a Functional Resonance Analysis Method (FRAM) model of the process for rescue of deteriorating patients in EGS, using information from 3 hospitals. A focus group approach will be used in co-designing reform of the system for responding to post-operative deterioration, working with small groups of frontline clinical staff from relevant areas in the three Trusts involved.
15742730|NCT04919707|Behavioral|Header Session|Participant fit with commercially available Storelli ExoShield Head Guard that has been fit with head impact sensors; participant completes a set of basic standing header tasks which mimic the types of purposeful heading anticipated to occur in actual play in soccer practice and games.
15742731|NCT04919707|Procedure|MRI Session|Scanning will include high resolution T1w imaging for 3-dimensional structural analyses, DTI and resting-state MRI for assessment of structural and functional brain network connectivity, as well as susceptibility-weighted imaging and multicomponent relaxometry to assess for microhemorrhages and myelin damage.
15742732|NCT04919694|Procedure|combination of orbital compression surgery and strabismus surgery|combination of orbital compression surgery and strabismus surgery at the same time
15742733|NCT04919694|Procedure|orbital compression|orbital compression
15742734|NCT04919681|Other|Stretch exercises|The intervention comprises of six weeks daily bi-lateral static stretching of the knee flexors. Stretches are performed seated on the ground. The participant sits upright on the floor with one leg straight. The sole of the other foot should be placed on the inside of the outstretched leg. The participant leans slightly forward, trying to touch their toes while maintaining full knee extension. Stretching is performed to the point of discomfort, and each stretch is held for 30-seconds for three repetitions.
15742735|NCT04919668|Behavioral|Simulated grocery shopping exercise|Participants will click a link and simulate an online grocery shopping experience by selecting items for 12 grocery categories.
15742737|NCT04919629|Biological|Bevacizumab|Given IV
15742738|NCT04919629|Biological|Pegcetacoplan|Given IV (only for loading dose) and SC
15742739|NCT04919629|Biological|Pembrolizumab|Given IV
15742740|NCT04919629|Other|Quality-of-Life Assessment|Ancillary studies
15742741|NCT04919629|Other|Questionnaire Administration|Ancillary studies
15742742|NCT04919616|Drug|TILs（Tumor Infiltrating Lymphocytes）|10e9, 10e10, 10e11 dose range of TILs, 3+3 dose escalation
15742743|NCT04919603|Behavioral|Enhanced physical activity intervention|the participants will take high-intensity exercise in accordance with High Intensity Interval Training (HIIT) prescriptions, with maximum heart rate and relative maximal oxygen uptake monitored. They will take both aerobic and resistance training exercise consecutively, and total training time will be expected to reach at least 150 minutes per week.
15742744|NCT04919603|Behavioral|Standard education|the participants will receive no extra intervention but diabetes health education, which will be carried out in large classrooms, in groups, and over the telephone. The education is mainly consisted of instructions on diabetes prevention according to < Guidelines for prevention and treatment of type 2 diabetes in China (2017 edition)
15742747|NCT04919577|Diagnostic Test|X-ray|We defined RSS as (1) the presence of symptoms such as nausea, vomiting, or abdominal fullness, (2) refasting after liquid or semi-liquid diets, (3) imaging methods (X-ray, CT, upper gastroenterography) confirmed without mechanical obstruction. All three conditions must be met at the same time and should occur within 30 days after operation.
15742748|NCT04919564|Drug|Furosemide|Furosemide 2 mg/hour for 12 hours since induction
15742749|NCT04919564|Other|Control|NaCl 0.9% 2 cc/hour for a period of 12 hours since anesthetic induction
15742750|NCT04919551|Drug|vicagrel|Oral administration after fasting/high-fat meal/low-fat meal
15742876|NCT04918264|Other|Uracil dosage|For each patient, uracil concentration will be evaluate and patients will be compared based on 16 ng/mL as threshold.
15742751|NCT04919525|Device|TrainPain|Participants will use gamified sensory perceptual training technology once daily for 28 days. This will involve participants completing a 15 minute sensory training session using the provided technology and viewing a 5 minute web based pain management lesson; additionally, participants will receive daily text messages. The device used in this study has two components. The first is a video game that can be downloaded onto any smartphone device. The second component is two vibrational devices that can be attached to the arms, legs, upper back, and lower back.
15742752|NCT04919512|Drug|TAR-200|TAR-200 will be administered.
15742753|NCT04919512|Biological|Cetrelimab|Cetrelimab will be administered.
15742754|NCT04919499|Drug|BI 765128|BI 765128
15742755|NCT04919499|Other|Sham comparator|Sham comparator
15742756|NCT04919486|Behavioral|visual feedback with non-weight bearing exercise|the training time is 12 weeks, twice a week, 60 minutes each time, a total of 24 times.
15742757|NCT04919486|Behavioral|elastic band exercise|the training time is 12 weeks, twice a week, 60 minutes each time, a total of 24 times.
15742758|NCT04919473|Biological|Gene Therapy product:vMCO-I|The vMCO-I is an adeno-associated virus serotype 2-based vector carried multi-characteristic opsin (MCO) gene expression cassette
15742759|NCT04919460|Other|clinical observation combined with pathological biopsy|Inspecting and palpating the oral cavity and neck of the screened object. If positive lesions are found, then further pathological biopsy will be performed.
15742760|NCT04919460|Other|Clinical observation, in vivo staining (reagent: toluidine blue) combined with pathological biopsy|(2) Inspecting and palpating the oral cavity and neck of the screened object. At the same time, in vivo staining is performed on each participant. The reagent used for staining is toluidine blue. As long as the screening subjects found positive lesions or abnormal living body staining, pathological biopsy was performed.
15742761|NCT04919447|Procedure|pacemaker implantation|cardiac pacing has been widely used in the treatment of bradyarrhythmias and heart failure, which can effectively improve the survival rate of patients.
15742762|NCT04919434|Other|IRECO|During 5 days, women included in the study will have to only use personal care product distributed by the research team.
15742763|NCT04919421|Drug|Dental injection and topical gel application|Topical anesthesia gel will be applied followed by dental injection with 1.8 ml Xylocaine 20mg/ml (DENSPLY Pharmaceutical); adrenaline: 1 : 100.000, delivered in cartridges using a 27 -gauge short needle (0.4 x 25 mm,C-K jet) and sterile non-aspirating syringe.
15742764|NCT04919421|Device|Dental injection and virtual reality device|Dental injection will be made while the participants are wearing virtual reality device.
15742765|NCT04919408|Other|telephone survey|telephone survey with a questionnaire to assess pain at 3 months and then 6 months after their cesarean section
15742766|NCT04919382|Biological|Atezolizumab|Given IV
15742767|NCT04919382|Drug|Temozolomide|Given PO
15742770|NCT04919356|Genetic|G2019S LRRK2|No cost genetic testing for G2019S LRRK2
15742771|NCT04919343|Behavioral|BBC Education Tiny Happy People videos|This intervention involves regular texting of BBC Education Tiny Happy People videos to parents
15742772|NCT04919343|Behavioral|Physical health control intervention|This intervention involves regular texting of publicly available videos about supporting infant physical and dental health to parents
15742773|NCT04919330|Behavioral|Family Acceptance and Commitment Therapy-based Eczema Management Programme|"The parent-child dyads will receive four weekly 2-hour sessions of family ACT-based eczema management programme (FACT-EMP). In each session, a group of 6-8 parent-child dyads will receive 90 minutes of ACT, followed by 30 minutes of education related to eczema management. Throughout the sessions, ACT strategies will help the dyads achieve the following therapeutic processes: To weaken the rumination cycle and fused thoughts related to eczema with body-image concern, shame and self-criticism for extending kindness and understanding to oneself; to build self-perspective-taking when seeing one's experience as part of the larger human experience; to strengthen their stands for their values related to self-kindness with acceptance of one's experience; and to take steps to act on values while practising kindness and compassion. Same as the waitlist control, the dyads will receive routine eczema care provided by the study hospital, including medical follow-ups and nurses' consultation."
15742774|NCT04919330|Behavioral|Wait-list Control Group|The parent-child dyads will receive routine eczema care provided by the study hospital, including medical follow-ups and nurses' consultation. To ensure equity of access to potentially effective treatment (i.e., family ACT-based eczema management programme), the dyads in the wait-list control group will receive the same programme after the completion of all assessments of the intervention arm.
15742775|NCT04919317|Drug|Dexamethasone 4mg|The experimental group received 4mg dexamethasone added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty.
15742776|NCT04919317|Drug|Saline|The control group received 1mL of 0.9% saline added to their bupivacaine block preoperatively just prior to bilateral reduction mammaplasty.
15742777|NCT04919291|Device|Topoguided LASIK|Topoguided ablation profile on dominant eye
15742778|NCT04919291|Device|Wavefront optimized LASIK|Wavefront optimized ablation profile on non-dominant eye
15742779|NCT04919278|Procedure|Chiropractic adjustments|Chiropractic adjustment is a procedure in which trained specialists (chiropractors) use their hands or a small instrument to apply a controlled, sudden force to a spinal joint. The goal of this procedure, also known as spinal manipulation, is to improve spinal motion and improve your body's physical function.
15742780|NCT04919265|Other|No intervention - mother-infant cohort study|There are no interventions because it is a mother-infant cohort study
15742781|NCT04919252|Drug|Vedolizumab|"Crohn's disease (CD): If a subject does not respond to vedolizumab 300mg iv 0, 2, and 6 weeks for induction, an additional dose of vedolizumab 300 mg will be given at week 10. On the other hand, Maintenance therapy should be continued every 8 weeks from week 14 in responding patients, and for some patients who have experienced a decrease in their response, it can be given every 4 weeks. The maximum dosing period is 54 weeks.
~Ulcerative colitis (UC): If a subject responds to vedolizumab 300mg iv 0, 2, and 6 weeks for induction, maintenance therapy should be continued every 8 weeks from week 14, and for some patients who have experienced a decrease in their response, it can be given every 4 weeks. The maximum dosing period is 54 weeks."
15743283|NCT04914624|Behavioral|ACBT training|Performed 5 days before surgery and one month after surgery, twice a day.
15742785|NCT04919226|Drug|CAPTEM (Capecitabine and Temozolomide)|Best standard of care treatment (investigator's choice [from the protocol comparator list]) according to individual risk-benefit assessment, institutional protocols, the local Prescribing Information, local regulations, or the local guidelines.
15742786|NCT04919226|Other|Amino-Acid Solution|The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of lysine and arginine diluted in an electrolyte solution.
15742787|NCT04919226|Drug|Everolimus 10 mg|Best standard of care treatment (investigator's choice [from the protocol comparator list]) according to individual risk-benefit assessment, institutional protocols, the local Prescribing Information, local regulations, or the local guidelines.
15742788|NCT04919226|Drug|FOLFOX (Folinic acid + Fluorouracil + Oxaliplatin)|Best standard of care treatment (investigator's choice [from the protocol comparator list]) according to individual risk-benefit assessment, institutional protocols, the local Prescribing Information, local regulations, or the local guidelines.
15742789|NCT04919200|Diagnostic Test|the single-breath helium dilution method and Whole-body plethysmography|The patients with obstructive lung disease simultaneously subjected to the single-breath helium dilution method and Whole-body plethysmography tests.
15742790|NCT04919174|Drug|Remimazolam|Sedation with remimazolam
15742791|NCT04919174|Drug|Dexmedetomidine|Sedation with dexmedetomidine
15742792|NCT04919161|Device|Body weight support system control group|The BWSS control group interventions consisted of various balance activities, including: marching, side-stepping, retro-ambulation, step-taps, and step-ups. The BWSS control group also practiced various gait tasks, including: ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.
15742793|NCT04919161|Device|Body weight support system with balance perturbations|"The BWSS with balance perturbations group conducted the same balance and gait activities as the control group, including: marching, side-stepping, retro-ambulation, step-taps, step-ups, ambulation over the ground, going up and down stairs, and performing sit-to-stand transitions.In addition, this arm will receive eight balance perturbations, two in each direction (lateral, anterior, and posterior) each session. BWSS-P participants will start at perturbation level one and progress up to level ten as appropriate. Each session, the perturbation level will be set based on the participant's progress."
15742794|NCT04919148|Behavioral|Heat risk and pro-environment behavior message|Eligible participants will be randomized to either a control condition to receive a standardized heat health warning or an intervention condition to receive a heat health warning plus figures depicting heat risk and pro-environment behavior via their preferred and accessible channel (WhatsApp, WeChat or the text message) each time when a Very Hot Weather Warning is issued by the Hong Kong Observatory.
15742795|NCT04919135|Biological|Umbilical Cord Mesenchymal Stem Cells transplantation|Patients assigned to UC-MSC administration groups will receive two administrations at a dose of 1.5 million cells/kg patient body weight via the IV route with a 3-month intervening interval
15742796|NCT04919135|Drug|standard frailty treatment and supplementary medication|Hightamine (Hankook Korus Pharm, Korea), Total calcium (Nugale Pharmaceutical, Canada), Bioflex (Ausbiomed, Australia)
15742797|NCT04919109|Biological|CodaVax-RSV|live attenuated vaccine against RSV
15742798|NCT04919109|Biological|Normal Saline|Placebo comparator
15742799|NCT04919096|Drug|SCB-420|Subjects randomised to SCB-420 arm will receive a total of 3 doses of SCB-420 as an intravitreal injection of 2 mg into the study eye every 4 weeks on Day 1, Week 4, and Week 8.
15742800|NCT04919096|Drug|Aflibercept|Subjects randomised to Aflibercept arm will receive a total of 3 doses of Aflibercept as an intravitreal injection of 2 mg into the study eye every 4 weeks on Day 1, Week 4, and Week 8.
15742801|NCT04919083|Other|Program of Therapeutic Exercise and Functional Recovery|"Specific hip fracture recovery programme,restoring the mobility, strength and balance of the operated patient, in order to facilitate the return to a functional state as close as possible to the state prior to surgery and in the shortest possible time, as detailed in Annex VIII. This programme is part of the standard treatment protocol implemented since January 2021 by the Orthogeriatrics Unit of the San Juan de Dios Hospital.
~This programme is divided into 5 phases, each of these phases coincides with a level of the gait assessment scale. Each individual will start at the level assigned by the doctor and will only have access to the videos of the indicated level and the levels below it. As the patient meets the recovery goals, the physician will provide access to the higher level videos.The functional recovery plan begins the day after the hip fracture and continues after the patient has been discharged for a total of 16 weeks."
15742802|NCT04919083|Other|Standardised nursing care plan|Consisting of postural changes described in the standardised nursing care plan. Within this plan, the patient was moved to a sitting position prematurely (within the first 24 hours) and started to ambulate within the following 48 hours, provided that the patient's general condition allowed it. This group did not receive any specific functional recovery plan.
15742803|NCT04919070|Behavioral|Connect for Caregivers|The intervention being studied is a single session guided behavioral intervention to improve social connectedness in caregivers of individuals with ADRD. The intervention, Connect for Caregivers, provides psychoeducation on the importance of social connectedness for health and well-being, includes a card-sort process to identify and prioritize barriers to connectedness, and provides personalized resources and strategies for caregivers to use to increase their social connectedness.
15742804|NCT04919057|Device|GelPOINT®|The patient is laid in the exaggerated lithotomy and 15 degree Trendelenburg position. An incision is made between both ischial tuberosities. Perineal dissection is performed till the apex of the prostate is seen. Subcutaneous tissue laying under the incision borders is dissected deeply over the superficial perineal fascia to place the GelPOINT®.Once the robotic system is docked, dissection of prostate is started.
15742805|NCT04919044|Other|Motor Imagery Training|The number of imagined contractions were 34 trials, each trial was 10 seconds with 5seconds rest between each trial and 2 minutes' rest was given after first 17 trials.
15742834|NCT04918693|Device|Ultrasound scanning|All participants will scan with and without device and trainee on 4 models. The order of the device assistance and models will be randomized between participants, but participant will always have exposure to device first before supervising the trainee.
15742807|NCT04919005|Other|Virtual Environment|The Virtual Environment was called SorrisoTur and consists of 10 mini-games with difficulty levels in a limited number of cities and mini-games distributed in a thematic scenario of the map of Brazil. The virtual environment consists of the cognitive training mini-games within a theme for all screens, mini-games, and information. The interventions with the Virtual Environment were administered in periods of one hour, twice a week, for a month.
15742808|NCT04918992|Diagnostic Test|Artificial Intelligence|investigators utilize a Artificial Intelligence (AI) supportive system to predict radiation proctitis for patients with pelvic cancers underwent radiotherapy
15742809|NCT04918953|Drug|methylprednisolone|The patients were treated with three protocols: (1) oral methylprednisolone, 40 mg for 3 days, 20 mg for 3 days, and 8 mg for 6 days; (2) oral methylprednisolone, 20 mg for 3 days, 10 mg for 3 days, and 4 mg for 6 days. At the same time, all patients received olfactory training for 12 weeks as proposed by Hummel et al
15742810|NCT04918953|Drug|budesonide atomization suspension|(3) budesonide atomization suspension (AstraZeneca Trading Co., Ltd, AU.) inhaled through the nose atomized with an air compression atomizer for 4 weeks, 2 mg for the first 2 weeks and reduced to 1 mg for the last 2 weeks. At the same time, all patients received olfactory training for 12 weeks as proposed by Hummel et al
15742811|NCT04918940|Biological|Determination of COVID-19 vacciantion efficacy|Samples will be taken after each vaccine injection to perform Sars-Cov-2 serology and Elispot interferon gamma and 3 months after the first vaccine injection
15742815|NCT04918914|Drug|Dapsone 100 MG|Dapsone 100-200 md orally daily, along with Cimetadine 400 mg PO TID
15742816|NCT04918901|Combination Product|NO Severe COVID-19|Non-severe and critically ill patients with COVID-19
15742817|NCT04918862|Drug|Granisetron|210 patients were enrolled, divided into two groups [Granisetron 1 mg: 105 patients received 1mg granisetron, Granisetron 3 mg: 105 patients received 3mg granisetron]. The two groups were compared in demographic characteristics (age, gender, weight, and height), hemodynamic parameters (MAP and HR), and duration of surgery
15742818|NCT04918823|Drug|Restasis|Subject will use one drop of Restasis in the lens before insertion
15742819|NCT04918810|Drug|Docetaxel intermittent|After 3 cycles of docetaxel chemotherapy (75mg/m^2 every 21) in combination with an undetectable mGSTP1 level, patients randomised to this arm will stop docetaxel treatment. Plasma mGSTP1 is measured every 21 days and docetaxel treatment will be recommenced if it mGSTP1 becomes detectable again.
15742820|NCT04918810|Drug|Docetaxel standard of care|After 3 cycles of docetaxel chemotherapy (75mg/m^2 every 21) in combination with an undetectable mGSTP1 level, patients randomised to this arm will continue with standard Docetaxel treatment (75mg/m^2 every 21)
15742821|NCT04918797|Biological|COVAXIN|Whole-Virion Inactivated SARS-CoV-2 Vaccine (COVAXIN®)
15742822|NCT04918784|Device|Restrata®|Restrata® is a sterile, single use device intended for use in local management of wounds. Restrata® is a soft, white, conformable, non-friable, absorbable matrix that provides a moist environment for the body's natural healing process to occur. Restrata® is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native extracellular matrix.
15742823|NCT04918784|Device|Wound Dressing|Alginate or Foam wound dressing is intended to manage wounds.
15742824|NCT04918771|Drug|Rafamin|"Oral administration - not with food. Keep the tablet in the mouth until it is completely dissolved.
~On the 1st day of treatment, 8 tablets are taken according to the following scheme: 1 tablet every 30 minutes in the first 2 hours (a total of 5 tablets in 2 hours), then during the same day, take another 1 tablet 3 times at regular intervals. On the 2nd day and then take 1 tablet 3 times a day. The duration of treatment is 5 days."
15742825|NCT04918771|Drug|Placebo|Oral administration - not with food. Placebo using Rafamin scheme.
15742826|NCT04918758|Device|Purastat Arm|"Generic name of device and principal intended use(s):
~Still PuraStat from a CE mark perspective. PuraStat is an aqueous self-assembling peptide solution of 2.5% concentration RADA16
~Indication for use:
~PuraStat is indicated for haemostasis in the following situations encountered during surgery, when haemostasis by ligation or standard means is insufficient or impractical:
~Bleeding from small blood vessels and oozing from capillaries of the parenchyma of solid organs. Oozing from vascular anastomoses
~Bleeding from small blood vessels and oozing from capillaries of the GI tract following surgical procedures
~Reduction of delayed bleeding following gastrointestinal endoscopic submucosal dissection (ESD) procedures in the colon."
15742827|NCT04918758|Drug|Standard Care Arm|Sucralfate enemas 2g twice daily for 8 weeks, this is standard care in patients with haemorrhagic radiation proctopathy in the short term
15742828|NCT04918745|Device|Cochlear Vestibular Implant (CVI)|"The Cochlear Vestibular Implant (CVI) is a modified cochlear implant (CI) which also incorporates a vestibular component (VI) in order to restore both hearing and vestibular function. Three vestibular stimulation algorithms will be compared in a randomized order (3 treatments x 3 periods, = 6 arms). These stimulation algorithms are:
~A - Constant stimulation
~B - Modulated stimulation based on angular head movement
~C - Modulated stimulation based on linear head movement"
15742829|NCT04918732|Diagnostic Test|FibroScan|The FibroScan device developed by Echosens (France) measures the liver stifness and steatosis based on a pulse of sound waves that goes through the liver.
15742830|NCT04918719|Drug|Acetylcysteine|The dosing of Acetylcysteine will be similar to the standard intravenous acetaminophen toxicity dosing: 150mg/kg in 200 milliliters of 5% Dextrose (D5W) infused over 1 hour, immediately followed by 50mg/kg in 500mL D5W infused over 4 hours, then 100mg/kg in 1000 milliliters D5W infused over 16 hours. (Any patient receiving t-PA who enrolls in the study will have their study drug infusion delayed by 24 hours after the completion of the t-PA infusion. )
15742831|NCT04918719|Drug|Dextrose in Water|The placebo will consist of a 5% Dextrose in Water instead of NAC (dosage and timigs are the same as the NAC arm). (Any patient receiving t-PA who enrolls in the study will have their study drug infusion delayed by 24 hours after the completion of the t-PA infusion. )
15742832|NCT04918706|Genetic|Allogeneic MSC|These MSCs will originate from bone marrow that will be aspirated from healthy volunteer donors screened by a trained physician of the center for stem cell therapy of LUMC
15742835|NCT04918680|Device|EcoFit® Total Hip System with implacross® E Polyethylene|The EcoFit® Total Hip System is a primary hip replacement system indicated for patients who are candidates for a primary cementless hip replacement. implacross® E Polyethylene is one of the components in the EcoFit® system.
15742836|NCT04918667|Combination Product|Berberine incorporated in gamma cyclodextrin|Experimental modified product. One capsule contains 250 mg of Berberine from Indian Barberry (Berberis aristate DC.) Bark and Root Extract incorporated in gamma-cyclodextrin
15742837|NCT04918667|Dietary Supplement|Berberine|Active comparator. One capsule contains 500 mg of Berberine from Indian Barberry (Berberis aristate DC.) Bark and Root Extract
15742838|NCT04918641|Other|assessment|Physical, developmental, neurological, behavioral, and neurocognitive assessments
15742839|NCT04918628|Drug|Sintilimab|A humanized anti-PD-1 monoclonal antibody
15742840|NCT04918615|Procedure|PCI|Patients in experimental group will undergo PCI with drug coated balloon catheter to treat the side branch of the coronary bifurcation lesion.
15742841|NCT04918589|Drug|Tranexamic acid|3 grams of tranexamic acid (30 mL of 100 mg/mL solution) diluted in 10 mL of normal saline
15742842|NCT04918589|Drug|Normal Saline|40 mL topical of 0.9% normal saline
15742843|NCT04918576|Drug|Tranexamic acid|3 grams of tranexamic acid (30mL of 100 mg/mL solution) diluted in 10 mL of normal saline
15742844|NCT04918576|Drug|Normal Saline|40 mL topical of 0.9% normal saline
15742845|NCT04918563|Drug|Nitroglycerin|Vasodilatator solution is dropped on the labial surface on the lateral incisor, so it can penetrate through the sulcus.
15742846|NCT04918563|Drug|Acetylcholine|Vasodilatator solution is dropped on the labial surface on the lateral incisor, so it can penetrate through the sulcus.
15742847|NCT04918550|Other|no drug and device|there is no intervention
15742848|NCT04918537|Dietary Supplement|Walnuts|30g of plain walnuts in addition to habitual food intakes
15742849|NCT04918524|Drug|Prednisone|5-30mg, po, once per day(Qd) prescribed if needed and adjusted due to patient response
15742850|NCT04918524|Drug|Hydroxychloroquine|100-200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.
15742851|NCT04918524|Drug|Aspirin|100mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response to 32 weeks of pregnancy. 75mg po, once per day (Qd) to 34 weeks of pregnancy. 50mg po, once per day (Qd) to 36 weeks of pregnancy.
15742852|NCT04918524|Drug|low molecular weight heparin Enoxaparin|40-60mg, ih, Subcutaneous injection, once per day (Qd) or twice per day (Bid) if needed and adjusted due to patient response.
15742853|NCT04918511|Drug|OPD5|OPD5 solution for i.v. infusion
15742854|NCT04918498|Behavioral|early physiotherapy programs|establishment of multidisciplinary teams, safety assessment, early activity physiotherapy and respiratory physiotherapy
15742855|NCT04918498|Behavioral|routine treatment|provide routine nursing and rehabilitation program
15742856|NCT04918485|Other|preoperative psychological intervention|including closing the relationship between nurse and patient , knowledge education,
15742857|NCT04918472|Procedure|MCCE|Mangetically controlled capsule endoscopy will be performed
15742858|NCT04918446|Other|T-POSE|Tablet based education and videos on opioid safety, use, and storage/disposal of the drug.
15742859|NCT04918446|Other|Usual Care|Printed instruction sheets on prescribed opioid.
15742860|NCT04918433|Procedure|Regional anaesthesia|Regional anaesthesia for sternotomy incision for congenital cardiac surgery
15742861|NCT04918420|Device|Flow diverter(Ton-bridgeMT, China)|The device is a self-expanding vascular stent system, which consists of a stent and a delivery system. The stent is made of platinum core nickel-titanium alloy material. The delivery system is composed of a delivery guide wire and an introduction sheath. The stent and the delivery guide wire are pre-installed in the introduction sheath.
15742862|NCT04918407|Drug|Empagliflozin 25 MG|25 mg
15742863|NCT04918407|Drug|Insulin|Insulin
15742864|NCT04918394|Other|Questionnaire of Mold / moisture exposure|"Mold / moisture exposure is assessed by the 5 following questions, whose positive response has been associated with the actual presence of mold in the household (according to data from the literature data), asked in the form of a parent-completed declarative questionnaire regarding the child's primary living home:
~Presence of visible mold
~Impression of dampness
~Apparent dampness
~Existence of recent water damage in the last year
~Presence of a moldy odor"
15742865|NCT04918381|Device|CellFX System|Nano-Pulse Stimulation (NPS)
15742866|NCT04918368|Behavioral|Behavioral scales were used|Women's Health Initiative Sleeplessness Scale (WHISS) and State Anxiety Scale (SAS), were applied.
15742867|NCT04918355|Other|Clinical Decision Support (CDS) alerts|CDS alerts are pop-up boxes integrated into the EHR. Each alert provides patient specific information, a link to the PDMP, instructions on how to dismiss the alert, a link to study-specific educational website, and a comment field.
15742868|NCT04918342|Other|Multidimensional Exercise Program|The multidirectional exercise program will include cardiovascular training, strengthening, balance training, and flexibility training. This will be delivered 2 times per week for 8 weeks using telehealth and will be delivered by a physical therapist. The exercises will be modified to meet the participants needs. Intensity of exercise interventions will be monitored through patient self report and use of continuous heart rate monitoring.
15742869|NCT04918329|Other|Observational study|Non interventional study
15742870|NCT04918316|Other|Corneal gas permeable lens|Fit in corneal gas permeable contact lens first.
15742871|NCT04918303|Device|SKNA recording|"The coupled recording of the sympathetic nervous activity of the skin and of an ECG will be carried out using the ME6000 device, CE marked, from the Bittium company.
~It will be performed for a maximum period of one hour at Day 1, Post-procedure between Day 1 and discharge from hospital, and month 6"
15742872|NCT04918290|Device|Tegaderm Eye Tape|Eye tape to protect the eye from corneal abrasions during surgery.
15742873|NCT04918290|Device|Transpore Eye Tape|Eye tape to protect the eye from corneal abrasions during surgery.
15742874|NCT04918277|Device|Assessment of gastric volume|Measuring the cross-sectional area of stomach in supine and right lateral decubitus
15742875|NCT04918264|Drug|Fluoropyrimidine treatment (5-FU or capecitabine) and dosage|In each group with an uracil dosage; at cycle 1; capecitabine or continuous 5-FU dose percentage will be evaluate retrospectively in our database
15743285|NCT04914624|Device|EDP-type II external diaphragm pacemaker|Use external diaphragm pacemaker to stimulate patients' diaphragms.
15742877|NCT04918264|Behavioral|Overall survival|For each group of patient, on 16 ng/mL as threshold for uracil concentration, overall survival will be compared betwen the two groups of patients (Uracil <16 vs Uracil ≥16).
15742878|NCT04918251|Procedure|128 electrode electroencephalography (EEG)|128 electrode EEG will be non-invasively recorded from electrodes placed in a montage over the scalp while the participant is resting or performing tasks designed to engage specific cortical motor networks of interest (cognitive, behavioural, motor and sensory)
15742879|NCT04918251|Procedure|Transcranial magnetic stimulation (TMS)|Single and paired pulse TMS protocol will be delivered while surface bipolar EMG is recorded over hand muscles to interrogate corticospinal tract function and cortical motor network component functions
15742880|NCT04918238|Other|Conventional program|All the participants will receive the conventional physical therapy protocol per session as following: Infrared radiation on the low back area for 15 minutes, Ultrasound waves (Digi sonic device) for 10 minutes on the trigger areas of the low back, Myofascial release of the thoracolumbar fascia, Stretching of the Paraspinal muscles and the hamstrings, Mobilization of the lumbar and thoracic spine from a prone lying position and strengthening of abdominal muscles, multifidus and transversal's abdominal muscle.
15742881|NCT04918238|Other|Muscle energy technique|The patient was in the lateral recumbent position on the side opposite to his, her side-bending dysfunction while the physiotherapist stood facing the subject. The physiotherapist monitored the lumbar area with one hand while with the other hand flexed the subject's knees and hips until the barrier was engaged at the vertebral segment being treated.
15742882|NCT04918225|Radiation|Magnetic Resonance Imaging|"Encephalic (about 30 minutes*)
~lesion location assessment: 3D FLAIR, 3DT1, 3DT2 (standard OFSEP protocol)
~lesion severity assessment: Axial magnetization transfer imaging (mt0, mt1)
~tract location assessment: 30 directions diffusion imaging (standard OFSEP protocol)
~B0 and B1 mapping to correct for B0 and B1 inhomogeneities
~● Spinal cord (about 50 minutes*)
~lesion location assessment: cervical and thoracic sagittal T2 TSE (0.7x0.7x2.5mm3), axial cervical MEDIC T2* (0.7x0.7x3mm3), axial thoracic T2 (0.5x0.5x3mm3)
~lesion severity assessment: Axial magnetization transfer imaging (mt0, mt1, 0.7x0.7x3mm3) on the cervical cord and on the thoracic cord
~tract location assessment: performed from registration on atlas
~B0 and B1 mapping to correct for B0 and B1 inhomogeneities"
15742883|NCT04918225|Diagnostic Test|Neurological examination|Global disability will be scored using the Expanded Disability Status Scale score
15742884|NCT04918225|Diagnostic Test|Multiple Sclerosis Functional Composite|"Walking disability will be scored using the 25-foot timed-walked test
~Arm disability will be scored using the nine-hole peg test"
15742885|NCT04918225|Diagnostic Test|Physiotherapist examination|"American Society Injury. Association motor subscore for each limb
~The muscle strength using a dynamometer. Two muscle groups will be tested for the upper (elbow flexors and extensors) and lower limbs (hip flexors and ankle dorsiflexion).
~The Ashworth Scale and the Tardieu Scale to assess spasticity."
15742886|NCT04918212|Device|Fabulous Stent Graft System|All patients received endovascular surgery using fabulous stent graft system
15742887|NCT04918199|Device|Computer based assessment (iBox)|Individual allograft survival probabilities of death censored allograft survival seven years after the time of risk evaluation, computed using the iBox (NCT03474003), a qualified prognostication system designed to predict long term allograft survival up to seven years after evaluation.
15742888|NCT04918199|Other|Physician assessement|Based on anonymized electronic health records, physicians have to determine a percentage of death censored allograft survival seven years after the time of risk evaluation,
15742889|NCT04918186|Drug|Durvalumab|1500mg IV, 60 min day 1 every 4 weeks
15742890|NCT04918186|Drug|BA3011|IV
15742891|NCT04918186|Drug|BA3021|IV
15742892|NCT04918186|Drug|To be determined|To be determined
15742893|NCT04918173|Drug|Atenativ|Antithrombin concentrate
15742895|NCT04918147|Drug|elotuzumab|Elotuzumab is a humanized recombinant monoclonal antibody (mAb) targeted against SLAMF7, a cell surface glycoprotein.
15742896|NCT04918147|Drug|placebo for elotuzumab|The placebo for elotuzumab is 0.9% sterile normal saline for injection.
15742897|NCT04918147|Drug|methylprednisolone|Premedication administered intravenously, 45 to 90 minutes prior to each elotuzumab/placebo infusion, per protocol. Dosage in milligrams (mg).
15742898|NCT04918147|Drug|diphenhydramine|Premedication administered orally or intravenously, 45 to 90 minutes prior to each elotuzumab/placebo infusion, per protocol. Dosage in milligrams (mg).
15742899|NCT04918147|Drug|acetaminophen|Premedication administered orally, 45 to 90 minutes prior to each elotuzumab/placebo infusion, per protocol. Dosage in milligrams (mg).
15742900|NCT04918147|Drug|famotidine|Premedication administered orally or intravenously, 45 to 90 minutes prior to each elotuzumab/placebo infusion, per protocol. Dosage in milligrams (mg).
15742901|NCT04918147|Drug|prednisone|Prescribed dosing with prednisone begins on the day of the first elotuzumab/placebo infusion, administered orally. The ten-week dosing taper proceeds, per protocol. Dosage in milligrams (mg).
15742902|NCT04918121|Drug|Yutiq 0.18 MG Drug Implant|a sustained-release steroid insert (Yutiq)
15742904|NCT04918095|Device|CareCOPD Platform|The subjects will be provided with CareCOPD devices for home monitoring of airway impedance, medication use, and symptoms data.
15742905|NCT04918082|Other|Quality of life questionnaires|Patients' quality of life will be assessed with self-reported items through both the EORTC-QLQ-C30 and EORTC-QLQ-BR23 modules.
15742906|NCT04918069|Drug|Capsaicin|Topical capsaicin ointment
15742907|NCT04918069|Drug|Placebo|Topical placebo ointment
15743026|NCT04916938|Behavioral|Mother's child psychotherapeutic session|Mother's representation of the event, mother's representation of the relation to her child, maternal emotions.
15743027|NCT04916938|Behavioral|Interview|History and perception of the mother's issues.
15742908|NCT04918056|Diagnostic Test|Hematological Analysis and Genetical Analysis|"Hematological Analysis: Hematological parameters were determined with an automated hematology analyzer (Sysmex, Japan), and hemoglobin analysis was performed with either high-performance liquid chromatography (Bio-Rad, USA) or capillary electrophoresis (Sebia, France and Helena, USA).
~Genetical Analysis: Genomic DNA was extracted from peripheral blood (PB) by using a standard phenol/chloroform method. The genotypes of samples are analyzed by NGS assay."
15742909|NCT04918030|Procedure|In-hospital staged PCI|After revascularization of the culprit lesion, all significant non-culprit vessel will be complete revascularzed during index the index procedure (7±3 day).
15742910|NCT04918030|Procedure|Out-hospital staged PCI|During the index procedure, patients will have treated with primary PCI the culprit lesion only. Patients will be hospitalized again after 30±15 days to undergo PCI of the other significant coronary lesions.
15742911|NCT04918017|Drug|International Guidelines Arm (Treatment based on subtypes: Esomeprazole or Itopride)|"Esomeprazole 40mg OD for EPS and Itopride 50mg TDS for PDS
~In overlapped EPS/ PDS: treat with Itopride 50mg TDS first and then add Esomeprazole 40mg OD (if partially responded- assessed at week 4) or treat with Itopride 50mg TDS first and then change to Esomeprazole 40mg OD (if not responded- assessed at week 4)"
15742912|NCT04918017|Drug|Routine Practice Arm (Esomeprazole)|Esomeprazole 40mg OD
15742913|NCT04918004|Behavioral|Sleep Hygiene|"One-to-one sleep hygiene training, the content of which was created by the researchers,
~A brochure containing 10 lifestyle changes related to sleep hygiene"
15742914|NCT04917991|Dietary Supplement|Extra Virgin Olive Oil-enriched chocolate spread|the intervention consists in the administration of 100g Extra Virgin Olive Oil-enriched chocolate spread each day for 14 days.
15742915|NCT04917991|Dietary Supplement|Palm Oil-enriched chocolate spread|the intervention consists in the administration of 100g Palm Oil-enriched chocolate spread each day for 14 days.
15742916|NCT04917978|Diagnostic Test|Hematological Phenotype Analysis|Hematological parameters were determined with an automated hematology analyzer (Sysmex, Japan), and hemoglobin analysis was performed with either high-performance liquid chromatography (Bio- Rad, USA) or capillary electrophoresis (Sebia, France and Helena, USA).
15742917|NCT04917965|Other|Laboratory clotting studies|Cord blood will be utilized to perform lab test including PT, aPTT, fibrinogen, platelet count, platelet mapping, and TEG6s
15742918|NCT04917952|Device|Blood Flow Restriction (BFR)|"Exercise: Bilateral knee extension at range 90ο-0ο
~Load: 30% 1RM
~BFR: Yes, 80% at both legs
~Sets: 4
~Reps: 30-15-15-15
~Rest: 30'' between sets
~Tempo: 2-0-2-0
~Participants of the intervention group will receive an exercise protocol with blood flow restriction once and will be measured for changes in PPT by the use of a digital dynamometer.
~Exercise protocol will be four sets of bilateral knee extension 90ο-0ο, reps per set 30-15-15-15, tempo 2-0-2-0 and rest 30 sec between sets.
~In order to determine the training load 30% of 1RM, participants will perform bilateral knee extension in range 90ο-0ο with pain-free maximum resistance. The derived 1RM will be used to determine the 30% 1RM load.
~Blood flow restriction will be applied at 80% by using pressure cuffs. The cuffs will be applied to the proximal thigh. Cuff pressure needed for a 100% vascular occlusion will be determined for each individual at a seated and relaxed position."
15742919|NCT04917952|Device|Sham Blood Flow Restriction (sham BFR)|"Exercise: Bilateral knee extension at range 90ο-0ο
~Load: 30% 1RM
~BFR: Yes, Sham BFR, 10mm Hg at both legs
~Sets: 4
~Reps: 30-15-15-15
~Rest: 30'' between sets
~Tempo: 2-0-2-0
~Participants of the control group will receive an exercise protocol with sham blood flow restriction once and will be measured for changes in PPT by the use of a digital dynamometer.
~Exercise protocol will be four sets of bilateral knee extension 90ο-0ο, reps per set 30-15-15-15, tempo 2-0-2-0 and rest 30 sec between sets.
~In order to determine the training load 30% of 1RM, participants will perform bilateral knee extension in range 90ο-0ο with pain-free maximum resistance. The derived 1RM will be used to determine the 30% 1RM load.
~Sham technique for blood flow restriction will be applied by using pressure cuffs inflated at 10mm Hg. The cuffs will be applied to the proximal thigh. Cuff pressure will be applied for each individual at a seated and relaxed position."
15742920|NCT04917939|Other|RNA sequencing|Samples in both groups will be sequenced by single-cell sequencing and spatial transcription sequencing.
15742921|NCT04917926|Behavioral|Financial and social incentives|Participants will be credited with HK$1,000 in their virtual accounts at the beginning of the trial. After baseline step counts are gathered in the second week, they will lose HK$40 for each subsequent week that they do not meet their personal weekly step target. Regarding social incentives, participants will be placed in teams of six, receiving feedback of their physical activity performance, rankings within their groups, and positive messages for encouragement. Nominated supporters will be informed of participants' performance for social support.
15742922|NCT04917926|Behavioral|Financial incentives|Participants will be credited with HK$1,000 in their virtual accounts at the beginning of the trial. After baseline step counts are gathered in the second week, they will lose HK$40 for each subsequent week that they do not meet their personal weekly step target.
15742923|NCT04917913|Dietary Supplement|Digestive enzyme blend|Subjects will take 3 capsules (one per meal) of digestive enzymes (50mg) daily for 30 days.
15742924|NCT04917913|Dietary Supplement|Placebo|Subjects will take 3 capsules (one per meal) of a placebo (50mg) daily for 30 days.
15742925|NCT04917900|Drug|Pyrotinib combined with albumin-bound paclitaxel and trastuzumab|Pyrotinib: 400mg, po,qd,with warm water within 30 minutes after breakfast, q3weeks, 6 cycles in total. Albumin-bound paclitaxel: 260mg/m2, iv, Day1, q3weeks, 6 cycles in total. Trastuzumab: The first cycle dose is 8mg/kg, and each subsequent cycle is 6mg/kg, iv, Day 1, q3weeks, a total of 6 cycles.
15742926|NCT04917874|Biological|Open Label Topical Beremagene Geperpavec (B-VEC)|Topical gel of non-integrating, replication-incompetent HSV-1 expressing the human collagen VII protein
15742929|NCT04917848|Other|Tele-Geriatric Oncology program|Participants will be scheduled to meet with a Geriatric Nurse Practitioner (GNP) or Geriatric Registered Nurse (GRN) via the program's telemedicine platform. The telemedicine encounters with the GNP/GRN may occur every 2 weeks over 3 months, for a total of 6 visits. Visits 1 and 6 are mandatory, and visits 2-5 are on an as needed basis.
15743028|NCT04916938|Behavioral|Self-rated questionnaires|Parental Self-Questionnaire to assess the perception of the evolution of the father, mother and child
15743286|NCT04914611|Other|No intervention|No intervention
15742930|NCT04917835|Device|PLADUO(PX1000)|Three sessions of argon- and nitrogen- NTAPP treatment at 1-week interval. Two passes of argon-NTAPP treatment and two passes of nitrogen-NTAPP treatment were sequentially performed in each session. Argon plasma at a pulse energy of 0.8 J/pulse with a 12 msec of pulse duration and nitrogen-plasma at a pulse energy of 0.75 J/pulse delivered with a 7 ms of pulse duration.
15742931|NCT04917822|Behavioral|Emotion regulation|Emotion regulation arm will provide the parents and children with four 2-hour weekly sessions. For the parents, the main topics include raising awareness of emotions (e.g., learning emotions theories), developing skills to manage emotions (e.g., attention deployment, cognitive changes, response modification), and facilitating parent-child relationship (e.g., gratitude). For children, the main topics are similar to that in parents' intervention. In this arm, we give more specific examples and simple explanations to the children.
15742932|NCT04917822|Behavioral|Information provision|Information provision arm will provide the parents and children with four 2-hour weekly sessions. For the parents, the main topics in these four sessions include learning the general information about Hong Kong such as education and medical care, housing condition, employment and training. For children, the main topics include learning the general information about Hong Kong, such as education, community facility, and learning method.
15742934|NCT04917796|Device|Electroacupuncture|Real and sham acupuncture will be delivered by experienced licensed acupuncturists at MSK. The intervention includes 10 treatments of acupuncture over 8 weeks (i.e., twice per week for two weeks, then one treatment per week for six weeks).
15742935|NCT04917796|Device|Sham Acupuncture|Real and sham acupuncture will be delivered by experienced licensed acupuncturists at MSK. The intervention includes 10 treatments of acupuncture over 8 weeks (i.e., twice per week for two weeks, then one treatment per week for six weeks).
15742936|NCT04917783|Behavioral|Passport Card|"After receiving neurocognitive testing, caregivers in the health-literacy group will be provided with a color-coded passport (a two-sided wallet-sized card) highlighting key findings and recommendations along with their written report. Then, approximately 7 - 14 weeks after testing, caregivers will complete a brief questionnaire in person during their follow-up clinic visit or via phone if necessary. The person completing the parent/caregiver/guardian report must have been present for the evaluation and feedback session and must be the parent/caregiver/guardian who received the feedback passport card and evaluation report."
15742937|NCT04917783|Behavioral|No Passport card|After receiving neurocognitive testing and verbal feedback from the psychologist, approximately 7 - 14 weeks after testing, caregivers will complete a brief questionnaire in person during their follow-up clinic visit or via phone if necessary. The person completing the parent/caregiver/guardian report must have been present for the evaluation and feedback session and must be the parent/caregiver/guardian who received the feedback and evaluation report, but not the passport card.
15742938|NCT04917770|Drug|Sintilimab in combination with Multimodality Radiotherapy|Participants will be treated with sintilimab in combination with multimodality radiotherapy
15742939|NCT04917757|Diagnostic Test|1mg Dexamethasone test|For each patient a 1mg dexamethasone test has been performed.
15742940|NCT04917744|Procedure|Biospecimen Collection|Undergo collection of blood samples
15742941|NCT04917744|Other|Laboratory Biomarker Analysis|Ancillary studies
15742942|NCT04917744|Other|Medical Chart Review|Review of medical charts
15742943|NCT04917731|Drug|Botox|Botox injected at digital artery
15742944|NCT04917718|Drug|Conversion from IR Tacrolimus to XR Tacrolimus|All participants will be consented to the study on IR Tacrolimus. After their baseline visit, they will be converted to XR Tacrolimus
15742945|NCT04917705|Other|Collection of biological samples|Skin, muscle fiber and blood sampling
15742946|NCT04917692|Drug|Empagliflozin|2.5 mg daily
15742947|NCT04917679|Drug|Eltrombopag plus diacerein|In the combination group, eltrombopag will be administered orally at an initial dose of 75mg daily for 14 days, and diacerein will be given orally at an initial dose of 50mg bid concomitantly for 14 days (D1-D14). During treatment period, treating physicians will modify the dosage of trial treatment to maintain participants' platelet count at the range of 50 - 150 × 10^9/L as follows: (1) if platelet count is less than 150 × 10^9/L, continue the original treatment (eltrombopag 75mg daily plus diacerein 50mg bid); (2) if platelet count is between 150 × 10^9/L to 250 × 10^9/L, the treatment will be modified to eltrombopag 50mg daily plus diacerein 50mg bid; (3) if platelet count is over 250 × 10^9/L, original treatment (both eltrombopag and diacerein) need to be stopped, and platelet count should be reexamined every other day, and the treatment (eltrombopag 50mg daily plus diacerein 50mg bid ) will be restarted until platelet count is below 100 × 10^9/L.
15742948|NCT04917679|Drug|Eltrombopag|In the monotherapy group, eltrombopag also will be administered orally at an initial dose of 75mg daily for 14 days (D1-D14), and the individualized dosage could be modified by treating physicians to maintain participants' platelet count between 50 × 10^9/L to 150 × 10^9/L.
15742949|NCT04917666|Behavioral|Horticultural therapy|A structured 8-session group therapy program, in which participants learn about plants, green spaces, plant-human interactions. During the program, the participants are guided by therapist to grow or take care of both indoor and outdoor plants, do small horticulture projects (like cooking, making drinks, herb projects).
15742950|NCT04917666|Other|Comparison|4 session of semi-structured and free engagement in activities of their choice. The activities that they could choose are mostly table-top activities which are solitary in nature, and does not require social interaction.
15743029|NCT04916925|Drug|Vitamin D|Adding vitamin D to PCOS patients who are resistant to clomiphene regime for induction will or not improve the Clinical pregnancy rate and will or not increase chances of ovulation and pregnancy.
15743030|NCT04916925|Drug|Clomid|CLOMID is adrug used for ovulation induction
15742951|NCT04917653|Device|Heart rhythm monitoring with wearable device|"The study compares the ability of lightweight measurement methods to detect different heart rhythms compared to the Holter registration.
~Faros 360 ECG sensor with wet electrodes. Faros 360 Holter is CE and FDA 510 cleared class 2a medical device, which is attached to the patient's chest with five single-use wet electrodes.
~Suunto Movesense one-time ECG device (Suunto Oy, http://www.suunto.com Vantaa Finland). Movesense is CE cleared consumer device, which is used with two dry electrodes to the ECG measurement.
~Empatica E4 activity bracelet (Empatica Ltd http://www.empatica.com Milan, Italy), which is CE cleared consumer device. Empatica E4 is a photopletysmogram which measures optically the amount of blood circulating in the blood vessel."
15742952|NCT04917653|Other|Blood samples and biomarkers|"Several blood samples will be collected during the study protocol in pre-defined times before and after the cardioversion intervention.
~Atrial peptides and cardiac troponins will be analyzed and kinetics estimated to predict the duration of early-onset AF period."
15742953|NCT04917640|Radiation|Radiation Therapy|Either SBRT or IMRT radiation therapy
15742954|NCT04917627|Drug|Vancomycin|one vial of vancomycin (1000 mg ) powder form.
15742955|NCT04917614|Device|Transcutaneous Electrical Acupoint Stimulation|Transcutaneous Electrical Acupoint Stimulation
15742956|NCT04917601|Behavioral|Evira Care treatment|The intervention aim to examine the effectiveness of using a digital support system (Evira) in treatment of childhood obesity. Through daily weighings at home using a special designed scale, which sends data directly to an application on the parents phone and to a clinic homepage, the child's weight development can be easily monitored. Participants can be randomized to either the intervention group or the control group. The control group will receive local standard treatment.
15742957|NCT04917601|Behavioral|Standard Lifestyle Care|The control group will receive the local standard care of treatment addressing lifestyles for childhood obesity without any restriction in visits or clinical support. This is the current standard care of treatment for childhood obesity.
15742958|NCT04917588|Combination Product|Saypha® FILLER Lidocaine (HQ)|Saypha® FILLER Lidocaine is administered by injection into the lips. The volume applied depends on the size of the area which requires correction and will be selected by the investigator. A maximum volume of 2 mL for both lips in total (i.e., for upper plus lower lip) including touch up might be needed per treatment but the treatment should not exceed 10 mL in total per treatment or 20 mL per year.
15742959|NCT04917588|Combination Product|Saypha® FILLER Lidocaine (C1)|Saypha® FILLER Lidocaine is administered by injection into the lips. The volume applied depends on the size of the area which requires correction and will be selected by the investigator. A maximum volume of 2 mL for both lips in total (i.e., for upper plus lower lip) including touch up might be needed per treatment but the treatment should not exceed 10 mL in total per treatment or 20 mL per year.
15742960|NCT04917575|Other|Mobile Game|An enhanced life-simulation prototype of a playable interactive game to increase HIV testing.
15742961|NCT04917575|Other|Mobile Application|A mobile application that will include basic information on HIV basics (e.g., routes of transmission, data on the epidemiology of HIV among youth), prevention information, and information on HIV testing and PrEP, as well as a link to the HIV risk estimator, and HIV testing and PrEP locators.
15742962|NCT04917549|Other|detection of oral lesions|oral lesions in patient diagnosed with COVID-19
15742963|NCT04917536|Procedure|Humeral neailling in humeral fractures|Humeral neailling in humeral fractures
15742964|NCT04917523|Biological|SARS-CoV-2 Vaccine (Vero Cell), Inactivated|0.5 mL per dose, containing 6.5U inactivated SARS-CoV-2 antigen
15742965|NCT04917510|Procedure|Erector spinae block|See experimental arm group description
15742966|NCT04917510|Procedure|Local block|See control and study arm group descriptions for the local block
15742967|NCT04917497|Drug|Levosimendan|Levosimendan was administered according to a standardized treatment protocol. A total dose of 12.5mg or 25mg (corresponding to one or two ampoules) was given at an infusion rate of 0.05 μg/kg/min to 0.2μg/kg/min with or without a loading dose (6 μg/kg or 3 μg/kg over 10 minutes). The decision about total dose, infusion rate and loading dose was at the discretion of the treating physician.
15742968|NCT04917484|Drug|Lu-177-DOTA-Octreotide|Lu-177-DOTATOC in standard doses or individualized doses.
15742969|NCT04917471|Dietary Supplement|Beet root juice|70 ml bid
15742970|NCT04917471|Dietary Supplement|Placebo juice|70 ml bid
15742971|NCT04917458|Drug|Cholecalciferol 4000 IU Oral Capsule, Liquid Filled|-Vitamin D 25 (OH) or Cholecalciferol 4000 IU capsules, each capsules contain Vitamin D3 tablet @ 1000 IU Patients included into the study will be randomized into two groups and receive placebo (as control group) or cholecalciferol administered orally for 3 months.
15742972|NCT04917458|Drug|Placebo|Placebo will be given to control group. It would be administrated orally, one capsule once a day for 30 days of study period
15742973|NCT04917445|Behavioral|Spikes-focused bad news protocol|Nurses trained to deliver bad news to IVF patients based on the Spikes-protocol for compassionately delivering bad news to patients.
15742974|NCT04917432|Procedure|intravascular ultrasound (IVUS)|Intravascular imaging using a specialized catheter delivered through intra-arterial approach to reach the coronaries to guide CTO-PCI procedure and optimize the results after wire crossing.
15742975|NCT04917432|Procedure|Conventional CTO PCI (non-IVUS guided)|Non-IVUS guided CTO PCI for wiring but may be used for results optimization after wire crossing
15742976|NCT04917419|Other|Luminotherapy and /or Psychoeducation Program|TO complete
15742977|NCT04917406|Drug|Application of lidocaine together with dexamethasone|Lidocaine 2% is applied on the positive pole while dexamethasone 4 mg/ml is applied on the negative pole. Through the use of current the drugs penetrate the fascia.
15742978|NCT04917406|Device|Application of ultrasound as physical therapy|The application dose will be 0.65 Watt for 7 minutes in the area of most painful affectation by means of a circular movement and a 1MZ head.
15742979|NCT04917393|Device|iRF System Multi-organ Denervation|The iRF System is a percutaneous, catheter-based device which uses RF energy to circumferentially denervate the sympathetic nerves surrounding the artery
15743031|NCT04916912|Procedure|coronary artery bypass grafting|Coronary artery bypass surgery is a surgical procedure to restore normal blood flow to an obstructed or stenotic coronary artery.
15743032|NCT04916899|Drug|Rifampicin/ Isoniazid/ Pyrazinamide/ Ethambutol|Form: Tablets Dosage: 150 mg / 75 mg / 400 mg / 300 mg Adminstration way: Oral
15743033|NCT04916886|Biological|Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.5ml|Containing 0.5E10vp
15742980|NCT04917367|Procedure|exploratory surgery|"For foreign bodies in the retropharyngeal space or parapharyngeal space above the esophageal entrance, close to the laryngopharynx cavity with large operating space, suspension laryngoscopy is the first choice according to the principle of proximity. In all cases, a lateral cleft laryngoscope was used to expose the posterior or lateral wall of the laryngopharynx, and 30° endoscope or microscope was used according to the skills of the surgeon.
~For a foreign body below the esophageal entrance, the lateral cervical incision was the first choice due to the small operating space of oral exposure. The lateral cervical incision and other open surgical methods are used for foreign bodies below the entrance of the esophagus or in the submaxillary space or for the anterior cervical band muscle foreign bodies."
15742981|NCT04917354|Device|Superb-Microvascular imaging|Device: Superb-Microvascular imaging Superb-Microvascular imaging: new sonographic software technique on ultrasonography to detect low-vascular flow without use of contrast media for ultrasonography
15742982|NCT04917341|Diagnostic Test|re-evaluation of endometrial biopsy samples by a gynecopathologist working at a university hospital|The endometrial biopsy samples taken at the second stage state hospital were re-evaluated by the gynecopathologist working at the university hospital and / or the repeated endometrial biopsy sampling was examined and the evaluation process was carried out in two steps.
15742983|NCT04917328|Other|compression ultrasound|performing a compression ultrasound
15742984|NCT04917315|Drug|JLP-2002 A mg|administration of JLP-2002 Participants received one vibegron A mg tablet, taken orally each morning, for 12 weeks.
15742985|NCT04917315|Drug|Placebo|administration of Placebo Participants received one placebo tablet, taken orally each morning, for 12 weeks.
15742986|NCT04917302|Drug|NMDAE plus AIFA|Use of an NMDA enhancer plus a drug with anti-inflammatory property for the treatment of schizophrenia.
15742987|NCT04917302|Drug|NMDAE plus Placebo Cap|Use of an NMDA enhancer plus placebo as a comparator
15742988|NCT04917289|Drug|Chemotherapy|Started chemotherapy or change the current adjuvant therapy
15742989|NCT04917276|Diagnostic Test|Circulating tumor cell|Detecting CTC in different time points of treatment (like PR, PD, pre and post-operation)
15742990|NCT04917263|Diagnostic Test|Immunohistochemistry, Flow citometry, Trascriptome analysis|we will perform immunohistochemistry, flow cytometry, transcriptomic analysis, mRNA microarray and mutational profiling
15742991|NCT04917250|Drug|Gemcitabine|1000mg/㎡，d1,4 ivdrip
15742992|NCT04917250|Drug|Pegaspargase|2500IU/㎡, maximum dose less than 3750IU
15742993|NCT04917250|Drug|Etoposide|100mg/㎡，d1-3 ivdrip
15742994|NCT04917250|Drug|Dexamethasone|20mg/d d1-4 ivdrip
15742995|NCT04917224|Radiation|Stereotactic Adaptive Ablative Radiotherapy at 50 Gy (Gray)|Cohort A will include 30 patients with central tumors; the dose regimen prescribed is 50 Gy (Gray) in 5 fractions with a 40 hour inter-fraction interval.
15742996|NCT04917224|Radiation|Stereotactic Adaptive Ablative Radiotherapy at 60 Gy (Gray)|Cohort B will include 30 patients with ultra-central tumors; the dose regimen prescribed is 60 Gy (Gray) in 8 fractions on consecutive days.
15742997|NCT04917211|Procedure|Virtual reality mask|"The virtual reality mask is a mask with a screen that is put on the patient's face in the theatre before the surgery. It offers 3D scenarios of about 20 to 40 minutes on five different themes (the Zen garden, the mountain, the forest, the beach, the scuba diving) with music. The video-headset, equipped with head movement sensors, allows the 3D vision of a natural virtual world and the audio-headset emits sounds adapted to the virtual world and music therapy. The RV mask, via multi-sensorial immersion, focuses on two therapeutic targets which are pain and anxiety. It is a non-drug approach cousin to hypnosis. Its therapeutic effects are based on a distractive effect: attentive capture, an emotional effect: playfulness and positive suggestion, and a behavioral effect: the patient participates and is an actor in his care.
~"
15742998|NCT04917198|Procedure|median sternotomy|median sternotomy
15742999|NCT04917185|Other|Electro-Acupuncture|Acupuncture used for thousands years is part of traditional Chinese medicine. We use electro-acupuncture to treat our patients because it is more sufficient than traditional acupuncture and proved effectively treating protracted withdrawal syndrome of opioid use disorder. Paired alligator clips of the EA apparatus will be attached to the needle holders of Shenmen and Neiguan points on both sides. EA stimulation will last for 30 min with a continuous wave of 2/100Hz and intensity of 10-15 mA which patients can stand. All needles will be removed in 30 min and use a dry sterilised cotton ball to press the points in case of bleeding.
15743000|NCT04917172|Diagnostic Test|postoperative acute pancreatitis evaluation|Surgical resection and reconstruction will be carried out according to the Institutional standards. After the surgical procedure, serum pancreatic amylase and lipase activity will be systematically measured two hours after surgery on postoperative day (POD) 0 and every day at 7 a.m. until POD 5 according to our institutional policy. At our institution, the upper limit of normal for serum pancreatic amylase is 52 U/L and for serum lipase is 60 U/L. Postoperative protocols included the routine measurement of inflammatory markers (white blood cell [WBC] count and C-Reactive Protein [CRP]). A urine trypsinogen strip test will be done on POD 1. A trypsinogen-2 concentration of more than 50 µg/l is considered a positive test. As routine clinical practice, a post-operative imaging will be scheduled to check for potential surgical morbidity. Abdominal magnetic resonance imaging (MRI) will be assessed on POD 3.
15743001|NCT04917159|Behavioral|ACT (Acceptance and Commitment Therapy)|The participants will learn 1) Mindfulness skills that promote changes in the relationship to the thoughts, feelings, action urges (E.g., depression, anxiety, caregiver burden, interpersonal difficulties, etc.) that can function as barriers to successful achieving better HRQoL for both patients and their caregivers. The skills such as mindfulness of breathing, listening and eating, leaves on the stream, and living-kindness exercise will be taught to patients and their family caregivers. Both conjoint and separated group-based formats will be provided. 2) Skills of values clarification and commitment to values-based actions allow individuals to reconnect with what is most important in their lives and promote value-based activities on health that reflect their internal motivators. The skills include values clarification, SMART goal setting for committed action. The rational bond between the patient and his/her family caregiver will be emphasized.
15743002|NCT04917159|Behavioral|HE (Health Education)|The educational contents of brief health education talks are based on the latest national clinical practice guideline for CHF, including symptoms monitoring, medication adherence, fluid and salt restriction, smoking cessation, alcohol consumption, and physical activity maintenance.ACT components are not covered.
15772023|NCT04678986|Other|ER2|No intervention, data analysis only
15743003|NCT04917146|Other|Self-administered questionnaires for relatives (caregivers=CG)|"Sociodemographic and medical information for the patient and the CG. SF36 questionnaire for the quality of life (physical, mental) of family CGs This assessment will be supplemented by specific questions relating to: physical health, emotional state, personal and leisure activities of the caregiver.
~The CG's knowledge and representations of the disease : questions adapted from the Brief-IPQ disease representation questionnaire.
~Questions will also focus on the caregiver's reactions to the patient's illness.
~We have constructed a questionnaire to assess the main areas of aid in the context of SSc: emotional, domestic help, administrative, medical, for trave (16 items and an open question).
~The CG Reaction Assessment-CRA questionnaire to assess the positive and negative dimensions of helping (24 items). It assesses five dimensions: self-esteem, financial impact, impact on health, impact on time and lack of family support.
~The reason for the assistance provided."
15743004|NCT04917133|Behavioral|Adapted Physical Activity program|classic 4-week rehabilitation program (standard care) + 6 APA workshops per week with collective care
15743005|NCT04917133|Other|Control|classic 4-week rehabilitation program (standard care)
15743007|NCT04917107|Behavioral|Qigong|"The Five Element Qigong Healing Movements practice includes five gentle horizontal and vertical arm and leg movements performed with guided breathing."
15743008|NCT04917094|Device|Compression stocking|"A below-the-knee compression stock will be worn daily for 2 weeks from waking up to before sleep.
~Bioelectrical impedance will be performed before and 2 weeks after wearing the stocking to assess the total body water content.
~Measuring the calf and neck circumference will be done before and after wearing the compression stocking. After 2 weeks, the patient will return back to the clinic for calf and neck circumference measurement.
~Sleep test will be done the night before and 2 weeks after wearing the compression stocking. Oxygen Desaturation Index(ODI) will be assessed through a level 4 home sleep apnea testing device.
~Patients recruited will have mild excessive to severe excessive daytime sleepiness and/or STOP-Bang score of 3 or more, with underlying conditions such as type II diabetes and hypertensive patients using the Epworth sleepiness scale. Epworth sleepiness scale will be assessed again 2 weeks after to assess for increase sleep efficiency."
15743009|NCT04917081|Behavioral|Mindful Self-Compassion|Mindful Self-Compassion has been developed by Neff and Germer as a specific kind of Mindfulness-Based Interventions to promote self-compassion. It combines the skills of mindfulness and self-compassion, providing a powerful tool for emotional resilience and enhancing the capacity for emotional wellbeing. In this study, a shortened version of the MSC program is used which is applied once a week for 75 minutes throughout the patients' stay in the rehabilitation clinic.
15743010|NCT04917081|Behavioral|Progressive Muscle Relaxation|Progressive Muscle Relaxation by Jacobson is a deep relaxation technique that helps relieve muscle tension and is based on the premise that mental calmness is a natural result of physical relaxation. In this study, Progressive Muscle Relaxation is applied once a week for 75 minutes throughout the patients' stay in the rehabilitation clinic.
15743011|NCT04917055|Drug|ropivacaine 0.25% with epinephrine and 6mg dexamethasone|Regional Nerve block behind the knee for posterior knee pain following total knee arthroplasty using ultrasound guidance, to be done distally between femoral chondyles
15743012|NCT04917055|Drug|Saline|Injection of Saline behind knee using ultrasound guidance
15743013|NCT04917042|Drug|Tazemetostat|Subjects will receive 520 mg/m2/dose (subjects 12-17 years old) or 800 mg of tazemetostat orally twice daily in 28 day cycles. Subjects will receive treatment with tazemetostat up to 2 years or until disease progression or unacceptable toxicity occurs.
15743014|NCT04917029|Drug|Bupivacaine hydrochloride perineurally|Arm 1; Bupivacaine hydrochloride 40 ml 0.25% perineurally in FICB
15743015|NCT04917029|Drug|Dexmedetmidine infusion|Arm 1: infusion of Dexmedetmidine 0.5 µg/kg/h
15743016|NCT04917029|Drug|Dexmedetomidine perineurally|Arm 2:Dexmedetomidine perineurally in FICB 80µg
15743017|NCT04917016|Diagnostic Test|Plasma B-HCG levels|Blood sample
15743018|NCT04917003|Other|RIC plus EDAS|Patients who are allocated into RIC group will undergo EDAS surgery combined 3-month RIC treatment. The opposite operation will be performed at 3 months after the first operation.
15743019|NCT04917003|Other|EDAS|Patients who are allocated into the control group will accept EDAS surgery twice. The second operation will be performed at 3 months after the first operation.
15743021|NCT04916977|Other|FD patients|Patients with Fabry disease diagnosis
15743022|NCT04916964|Other|Test and exercise home-based program|"Eight home-based physiotherapy sessions will occur in two months, once a week, to activate the preserved implicit memory (PIM). The recommendations are to train three weeks with the same exercise program, three times a week (one time coached by the attributed physiotherapist and two times coached by a natural or family caregiver). After three weeks, the participants can choose if they want to keep the same exercises or change all or some of these, in testing other tasks. Every training session will be planned to last 45 minutes. During each training session, the participant will note on his/her own Training booklet each task performed. The Training booklet will be used to plane, organize, and remember details for the next training session."
15743023|NCT04916951|Drug|Amoxicillin|oral one-time dose of amoxicillin
15743024|NCT04916951|Drug|Cephalexin|oral one-time dose of cephalexin
15743025|NCT04916938|Behavioral|Interaction Guidance Therapy|Mother child psychotherapy based on video-feedback interaction after a free play session. The therapy usually enhances parent sensibility to the child.
15743034|NCT04916886|Biological|Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) 0.3ml|Containing 0.3E10vp
15743036|NCT04916847|Other|blood collection|"Depending on the weight of the child, between 5ml and 15ml of blood will be collected during a blood test necessary for the conventional care of the patient. A second blood sample will be taken one year later. The volume of blood taken does not exceed the volume allowed by the guideline Ethical considerations for clinical trials of medicinal products conducted in the paediatric population.
~We will analyse:
~Specific antibody responses (IgM, IgG, and immunoglobulin A (IgA) anti SARS-Cov-2) by quantitative chemiluminescence analysis.
~Protective neutralizing capacity of these antibodies (neutralizing antibodies against SARS-cOV-2) by neutralization test.
~SARS-Cov-2 specific memory T cell responses by multiparametric flow cytometry in order to characterize their maturation, differentiation, senescence, activation, secretion of interleukin (cytokines 2) , IFN-g, TNF) or Interferon-gamma (IFN-g) ELISPOT assay."
15743037|NCT04916821|Dietary Supplement|propolis|Propolis may be blocked virus entry to cells, and some receptor binding and some cell signal molecules
15743038|NCT04916808|Diagnostic Test|DCISionRT Test|The Prelude DCISionRT Test was developed by Prelude Corporation and is performed at its CLIA laboratory facility. The biomarkers used to evaluate the biologic signature of DCIS tissue are based on over a decade of research including the University of California, San Francisco, Yale University as well as Prelude Corporation. The test is prognostic for 10-year recurrence risk and predicts RT treatment benefit for invasive breast cancer. The laboratory is regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing and is accredited by the College of American Pathologists (CAP).
15743041|NCT04916782|Other|Quality of life Questionnaire|Quality of life questionnaire
15743042|NCT04916769|Drug|Bosutinib capsule|500 mg dose of bosutinib capsule contents mixed with applesauce
15743043|NCT04916769|Drug|Bosutinib capsule|500 mg dose of bosutinib capsule contents mixed with yogurt
15743044|NCT04916769|Drug|Bosutinib capsule|500 mg dose of intact bosutinib capsules
15743045|NCT04916756|Drug|Baricitinib 2 MG|baricitinib 2mg per day for 24 weeks
15743046|NCT04916743|Other|Intradialytic exercise group|Participants will do concurrent exercise (a combination of aerobic exercise and resistance training) for 30-60 minutes during the second hour of their routine hemodialysis sessions. To determine the intensity of the prescribed exercise, maximum heart rate is used for aerobic workout and 5 Repetitions Maximum (5RM) for resistance protocols. Exercises will be performed at a moderate exercise intensity (12-14 on the Borg RPE Scale). All protocols are tailor-made based on each individual's needs and physical abilities.
15743047|NCT04916730|Behavioral|Standard of Care|Participants in this arm will receive nutritional counseling from the study dietician but will not be required to adopt a 10-hr eating window.
15743048|NCT04916730|Behavioral|Time Restricted Eating|Participants in this arm will adhere to a daily, consistent self-selected 10-hr eating window for the course of the study intervention period as well as receive nutritional counseling from the study dietitian.
15743049|NCT04916717|Other|Counseling|Face-to-face and telephone counseling were applied to individuals in the intervention group.
15743050|NCT04916691|Procedure|EPSB for rib fractures|EPSB for rib fractures
15743051|NCT04916691|Drug|Ropivacaine|Standard of care weight-based optimal Ropivacaine dosing for ESPB
15743053|NCT04916665|Drug|Teduglutide|bridging intestinal failure with teduglutide until reconstruction
15743054|NCT04916652|Radiation|MRI|MRI is a safe, non-invasive, cutting edge imaging technology widely used to study the human brain both internationally (NIH connectome project) and in China (China Brain Project). The Baby Connectome Project (BCP) led by NIH scientists has begun data collection on the structural and functional brain development among American infants (Howell, Styner et al. 2019).
15743055|NCT04916639|Device|Device: Physiomer undiluted seawater nasal spray|"In this study, subjects are asked to adhere to the following dosage during the 3 weeks of the study:
~Nasal wash four times every day
~These washes are to be carried out in each nostril
~By continuously pressing the spray for 3 seconds in each nostril
~Subjects are recommended to distribute the 4 nasal washes as follows:
~1st : morning
~2nd : midday
~3rd : afternoon
~4th : evening Subjects will be instructed to maintain daily nasal wash over the 3 weeks study period even in case of earlier nasal symptoms resolution, in order to assess the impact of nasal wash on viral load and other COVID-19 symptoms."
15743056|NCT04916626|Behavioral|OPUS YOUNG|OPUS YOUNG is a two year out-patient specialized early intervention service for children and adolescents with a first episode psychosis. The OPUS YOUNG treatment consists of the following elements: modified assertive community treatment, low patients to case manager ratio, cognitive-behavioural case management (CBCM), psycho-educational family treatment including multiple family groups(MFG) and psychoeducational siblings groups, Social Cognition and Interaction Training (SCIT), possible individual Cognitive Behavioural Therapy (CBT) in addition to CBCM, and manual based psychopharmacologic treatment. Additional, special transition support, individual school/employment support, and prevention and treatment of substance abuse.
15743057|NCT04916626|Behavioral|Treatment as Usual|The patients allocated to TAU will be offered non-manualized treatment following national Danish guidelines and local guidelines. Treatment is provided by a multidisciplinary team and consists of case-management (no defined upper case load), family support and psychoeducation, in addition to psychopharmacological treatment. In some cases, social skills training and CBT may be offered. In general, office visits take place in outpatient clinics.
15743058|NCT04916613|Drug|Darolutamide 300 mg|600 mg po, b.i.d.
15743059|NCT04916613|Drug|Placebo|po, b.i.d.
15743060|NCT04916613|Drug|Androgen deprivation therapy|Use according to local standard of care
15772576|NCT04674605|Device|biomarkers|biomarkers
15743062|NCT04916587|Other|Implementation Strategy of ACEs Screenings|We will use implementation mapping, guided by the EPIS framework, to promote a co-created process and refine the strategy comprised of online training videos, a customized ACEs algorithm and use of technology to improve workflow efficiency, implementation technical assistance/coaching, and written implementation protocols.
15743063|NCT04916587|Other|Usual Care|"The ACEs Aware policy goal is to equip providers with training and clinical protocols to screen children and adults for ACEs, detect ACEs early, and connect patients to interventions, resources, and other support to improve patient health and well-being. ACEs screenings are comprised of: a) a 2-hour on-line provider training; b) the Pediatric ACEs and Related Life-events Screener or PEARLS tool; c) an ACEs associated health conditions checklist; and d) complete a wellness exam. The primary care provider uses multiple sources of information to identify a child's need for follow-up services."
15743064|NCT04916574|Other|Nasal Spray Containing Anti-SARS-CoV-2 Antibodies Derived from Bovine Colostrum|Concentration of active substance on nasal mucosal surface in time
15743065|NCT04916561|Diagnostic Test|RT-PCR|Detection of Covid-19 in bone, articular fluid and muscle samples using RT-PCR
15743066|NCT04916548|Drug|Intravenous Ketamine|Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
15743067|NCT04916535|Other|diagnostic flow|exams to estimate the risk of adverse events in patients with MAD
15743068|NCT04916522|Drug|Colchicine|0.5 mg once daily
15743069|NCT04916522|Drug|Placebo|Once daily
15743070|NCT04916509|Drug|Palbociclib plus an aromatase inhibitor|Palbociclib plus an aromatase inhibitor therapy
15743071|NCT04916509|Drug|Palbociclib plus fulvestrant|Palbociclib plus fulvestrant
15743072|NCT04916496|Behavioral|Acceptance and Commitment Therapy-based lifestyle counselling programme|"The ACT-LCP Group will receive an ACT-based lifestyle counselling programme, which composes of 5-weekly group sessions (2 hours per each, 15 hours in total). Acceptance, mindfulness, values clarification skills/exercises will be used to help patients to increase self-perspective taking and willingness to experience distressing sensations, discomfort and urges while engaging in healthy lifestyle behaviours.
~One month after the programme, the participant will receive one 'booster' session (2 hours), followed by 2-weekly telephone follow-up calls (20-30 minutes per call) to evaluate the effort of behavioural change."
15743073|NCT04916496|Behavioral|Healthy lifestyle talk|"The Control Group will receive one 2-hour, healthy lifestyle education talk (at least 10 patients in the talk) based on the HEARTS technical package as recommended by the WHO as routine care. This package includes a collection of evidence-based protocols which standardizes a clinical approach to promote a healthy lifestyle among adults. The Control Group will receive routine psychiatric outpatient/rehabilitation services as provided by the clinic in NDH/community centre.
~One month after the talk, three weekly follow-up telephone calls (20-30 minutes) will be arranged for each patient in the Control Group to evaluate the effort of behavioural change."
15743074|NCT04916483|Other|group cognitive stimulation therapy|The experimental group will receive totally 7 weeks,14 sessions, twice a week, and 60 minute group cognitive stimulation therapy (GCST).
15743075|NCT04916483|Other|usual care|The control group maintains the unit routine treatment.
15743078|NCT04916444|Device|rTMS|repetitive transcranial magnetic stimulation is a painless, noninvasive form of neurostimulation. This study uses an accelerated protocol in which the neurostimulation pulses are delivered in 4 sessions per day over 4 consecutive days (16 total sessions). Active or sham rTMS will be provided at 9 weeks following botox injections.
15743079|NCT04916431|Drug|mRNA-6231|Sterile frozen liquid dispersion for injection
15743080|NCT04916418|Drug|Placebo|TTP block with initial dose of placebo (NaCl0.9%) 20 ml per catheter (total volume 40ml), followed by 20 ml per catheter every 8 hours until 72 hours from the first dose has passed.
15743081|NCT04916418|Drug|Ropivacaine|TTP block with initial dose of ropivacaine 0.5% (5 mg / ml) 20 ml per catheter (total volume 40ml), followed by doses of ropivacaine 0.2% (2 mg / ml) 20 ml per catheter every 8 hours until 72 hours from the first dose has passed.
15743082|NCT04916405|Other|Standardized management of pregnancy weight of twin pregnancy|Standardized management of pregnancy weight of twin pregnancy
15743083|NCT04916392|Drug|Liposomal bupivacaine|5ml of 1.33% liposomal bupivacaine with 5 ml of 0.9% normal saline will be given to treatment group.
15743084|NCT04916392|Drug|Bupivacaine|10ml of 0.5% bupivacaine will be given to control group.
15743085|NCT04916379|Dietary Supplement|Momordica charantia|Momordica Charantia: 2000 mg per day for 12 weeks
15743086|NCT04916379|Other|Placebo|Placebo: 2000 mg per day for 12 weeks
15743087|NCT04916366|Other|Kinesio taping|Kinesio taping in a bandage to treat musculoskeletal pain.
15743088|NCT04916366|Other|Conventional bandage|It will be used a conventional bandage applicated in the same neck region than kinesio taping intervention.
15743089|NCT04916353|Drug|hypertonic dextrose water|20% hypertonic dextrose water injection for chronic shoulder pain
15743090|NCT04916353|Drug|Triamcinolone Acetonide.|Triamcinolone Acetonide 40mg/1ml injection
15743091|NCT04916340|Behavioral|Muscular Strength Training Group|"Week 1 3 days/week Bench Press - 1 set at 80% of one repetition maximum
~(1RM) Bent Over Row - 1 set at 80% 1RM Back Squat - 1 set at 80% 1RM Romanian Deadlift - 1 set at 80% 1RM
~Week 2 3 days/week Bench Press - 2 sets at 80% 1RM Bent Over Row - 2 sets at 80% 1RM Back Squat - 2 sets at 80% 1RM Romanian Deadlift - 2 sets at 80% 1RM
~Weeks 3-10 3 days/week Bench Press - 3 sets at 80% 1RM Bent Over Row - 3 sets at 80% 1RM Back Squat - 3 sets at 80% 1RM Romanian Deadlift - 3 sets at 80% 1RM"
15743092|NCT04916340|Behavioral|Muscular Fitness Training Group|"Week 1 3 days/week Bench Press - 1 set at 65% 1RM Bent Over Row - 1 set at 65% 1RM Back Squat - 1 set at 65% 1RM Romanian Deadlift - 1 set at 65% 1RM
~Week 2 3 days/week Bench Press - 2 sets at 65% 1RM Bent Over Row - 2 sets at 65% 1RM Back Squat - 2 sets at 65% 1RM Romanian Deadlift - 2 sets at 65% 1RM
~Weeks 3-10 3 days/week Bench Press - 3 sets at 65% 1RM Bent Over Row - 3 sets at 65% 1RM Back Squat - 3 sets at 65% 1RM Romanian Deadlift - 3 sets at 65% 1RM"
15743093|NCT04916327|Dietary Supplement|Antioxidant|Subjects will ingest an antioxidant cocktail containing 800 milligrams of alpha lipoic acid, 1 gram of vitamin C (ascorbic acid), and 400 milligrams of vitamin E (alpha tocopherol).
15743094|NCT04916327|Dietary Supplement|Placebo|Subjects will ingest placebo (microcrystalline cellulose) pills.
15743095|NCT04916314|Behavioral|Low Carbohydrate diet|Second Nature is a three-month remote behavioural change programme with mentoring from a registered dietitian or nutritionist (health coach), encouraging adoption of a low energy, low-carbohydrate diet, peer group support, structured education articles and activity tracking technology. These elements are accessed via a smartphone or web-based application; each participant additionally receives an instructional handbook, and recipe book (+/-wireless weighing and activity tracking technology).
15743096|NCT04916301|Behavioral|Early Mother-Infant Attachment|Early Mother-Infant Attachment Indicators will be observed.
15743097|NCT04916288|Device|central venous cathterization|central venous catheterization through the right internal jugular vein
15743098|NCT04916275|Other|Cognitive tests|Optional tests: Corsi block-tapping task, Stroop test and Iowa gambling task
15743099|NCT04916249|Drug|Tibetree Pain Relieving Plaster|Participants who provide informed consent in the trial will receive either the Tibetree pain relieving plaster if randomized into the intervention arm, or an identical placebo plaster if randomized into the control arm. The treatment course for both arms are identical. Participants will be instructed to apply the plaster directly to the skin overlying the area of pain for 6 hours once daily for 14 consecutive days.
15743100|NCT04916249|Other|Placebo|Participants who provide informed consent in the trial will receive either the Tibetree pain relieving plaster if randomized into the intervention arm, or an identical placebo plaster if randomized into the control arm. The treatment course for both arms are identical. Participants will be instructed to apply the plaster directly to the skin overlying the area of pain for 6 hours once daily for 14 consecutive days.
15743101|NCT04916236|Drug|RMC-4630|"SHP2-inhibitor
~Powder in capsule
~Administered on day 1 and day 2 of every week"
15743102|NCT04916236|Drug|LY3214996|"ERK inhibitor
~Powder in capsule
~Administered every day"
15743103|NCT04916223|Other|Therapeutic massage|"The massage therapists were scheduled on a rotating schedule with two alternates scheduled for each day to ensure adherence to assigned study arm and to avoid therapist effect as much as possible. For each enrolled subject, the therapist assessed the subject and created a treatment plan depending on his/her individual needs and preferences. For example, if a subject reported bothersome lower extremity pain, the therapist might focus the massage on that lower extremity or might avoid massaging that lower extremity, depending solely on the preference of the subject. Massage duration was determined by the assigned study arm."
15743104|NCT04916197|Drug|Dexmedetomidine prolonged group|Dexmedetomidine for 24h after patients finished mechanical thrombectomy and returned to ICU.
15743105|NCT04916197|Drug|Placebo group|Placebo（Equal dose of saline）24h after patients finished mechanical thrombectomy and returned to ICU.
15743106|NCT04916184|Other|aerobic exercise|exercise training rehabilitation (aerobic exercise with/without strength training)
15743107|NCT04916184|Other|combined exercise|exercise training rehabilitation (aerobic exercise with/without strength training)
15743108|NCT04916171|Other|incidence|It is aimed to determine the incidence of endometriosis and/or adenomyosis in patients diagnosed with polycystic ovary syndrome, or to determine the incidence of polycystic ovary syndrome in patients diagnosed with endometriosis and/or adenomyosis.
15743109|NCT04916145|Device|SAT-008|SAT-008 is a digital device containing several types of activities related to the immune function of adults.
15743110|NCT04916132|Procedure|Kidney Biopsy|Harvesting of kidney tissue from people with type 2 diabetes and albuminuria for subsequent analysis
15743111|NCT04916119|Drug|IBI323|In phase Ia study, seven dose levels of IBI323 (0.03, 0.1, 0.3, 1, 3, 10 and 20mg/kg) will be tested. The DLT observation period is 28 days. IBI323 is administered by iv infusion day 1 of every 14 days. After dose escalation stage completed, two dose levels (10mg/kg and 20mg/kg) will be expanded to 20 patients each. In Phase Ib study, IBI323 is administered RP2D by iv infusion day 1 of every 14 days. IBI323 and chemotherapy will be administrated in cohort C and cohort K
15743112|NCT04916106|Device|Transcutaneous Electroacupuncture|give diffrent parameter TEA treatment for 4 weeks.
15743113|NCT04916093|Drug|Vildagliptin 50 MG|Galvus 50 mg oral tablets
15743114|NCT04916093|Drug|Sitagliptin 100mg|Januvia 100mg oral tablets
15743115|NCT04916093|Drug|MetFORMIN 1000 Mg Oral Tablet|Glucophage 1000 mg oral tablets
15743116|NCT04916080|Drug|N-acetyl cysteine|mucolytic and anti-oxidant. Dose 10mg/Kg/ 12 hours orally
15743117|NCT04916067|Device|Mesh Implantation|Implantation of Phasix™ Soft Mesh - a knitted monofilament mesh scaffold using Poly-4-hydroxybutyrate (P4HB), a biologically derived material - to prevent hernia formation
15743118|NCT04916041|Device|Cataract surgery with bilateral implantation of the same type of intraocular lens|Cataract surgery with bilateral implantation of the same type of intraocular lens
15743121|NCT04915989|Drug|GX-19N|DNA vaccine expressing SARS-CoV-2 S-protein antigen including the Nucleocapsid protein (NP) antigen
15743122|NCT04915963|Dietary Supplement|Vitamin D supplementation|Patients are randomized to receive vitamin D or placebo and followed up for 15 days at maximum to investigate the safety and clinical efficacy of the supplements
15743123|NCT04915950|Drug|Temanogrel|Participants will receive a single oral dose of temanogrel during the treatment visit.
15743124|NCT04915950|Drug|Placebo|Participants will receive a single oral dose of temanogrel matching placebo during the treatment visit.
15743125|NCT04915937|Other|Study Infant Formula|RTF milk-based infant formula with oligosaccharides
15743126|NCT04915924|Device|HeartMate 3™ left ventricular assist system (HM3 LVAS)|Advanced heart failure patients will be implanted with the HM3 LVAS
15743127|NCT04915911|Other|cross-sectional study|cross-sectional study
15743128|NCT04915898|Other|Oral Hygiene - teeth brushing|Oral hygiene using a special kit with recommended materials and instructions: Use of an ADA approved toothbrush, toothpaste with dentifrice, antiseptic mouthwash and non-drying lip moisturizer encouraged after meals and at bedtime
15743129|NCT04915885|Other|Routine care|Routine contraceptive counseling and routine method availability
15743130|NCT04915885|Other|Package of contraceptive counseling interventions|The implementation package will be co-designed by providers and clients during the formative and research design phases
15743131|NCT04915885|Other|Expanded methods|Expanded range of contraceptive methods as recommended by national policies
15743132|NCT04915872|Procedure|Blood sampling (T0, inclusion)|Blood sample (5 ml) at 30 minutes after the loading dose of 4g/0.5g over 30 minutes for therapeutic drug monitoring at peak concentration (Cmax)
15743133|NCT04915872|Procedure|other samplings (T1)|"- T1 : Day of the first surgical revision, under PTZ administered by continuous infusion : Blood sample (5 ml) for therapeutic drug monitoring at steady state concentration (Css).
~Urinary sample and collection of urinary volume between T0 and T1 (Urinary Clearance) NPT fluid sample and collection of NPT volume between T0 and T1 (Peritoneal Clearance) Peritoneal sampling for therapeutic drug monitoring at the site of infection (CPt)"
15743134|NCT04915859|Other|Hand Cooling at 12-15 degrees celsius|hand cooling at 12-15 degrees celsius will be performed for active cooling by having participants place their hands on the cooling device set to this temperature
15743135|NCT04915859|Other|Hand Cooling at 16-20 degrees celsius|hand cooling at 16-20 degrees celsius will be performed for active cooling by having participants place their hands on the cooling device set to this temperature
15743136|NCT04915859|Other|hand and back cooling at 12-15 or 16-20 degrees celsius|hand and back cooling at 12-15 or 16-20 degrees celsius will be performed for active cooling by having participants place their hands on the cooling device set to this temperature while also wearing the back wrap cooling device set to this temperature
15743137|NCT04915859|Other|Passive cooling|"participants will sit in a chair and passively cool (no active intervention)"
15743138|NCT04915846|Drug|ApoTamox 10mg|All participants will receive tamoxifen (ApoTamox) for approximately 6 months (6 months + 1 week). Participants and study staff will be blinded as to whether the participants are starting with the placebo or the drug. Depending on randomization, drug or placebo will be dispensed at the end of the t=0 study visit (Phase 1). Dosing will commence the day after the t=0 study visit. At the end of Phase 1, participants will enter a 'washout' period, when they will cease treatment. After approximately 3 months of washout, participants will cross-over to the other treatment regimen and receive the other interventional product (IP) for the final 6 months of their study participation (Phase 2).
15743139|NCT04915846|Drug|Placebo|placebo comparator
15743140|NCT04915833|Diagnostic Test|Standard high-definition colonoscopy|"Evaluation of the colonic mucosa with a high definition colonoscope (EPKi7010 video processor).
~The endoscopy images will be seen on a 27inch, flat panel, high-definition LCD monitor (Radiance™ ultraSC-WU27-G1520 model) only by one expert endoscopist, randomly assigned.
~The number, location and polyps' features (Paris classification) will be recorded by the operator. If a polyp is detected, the endoscopist will remove the polyp endoscopically with a cold snare and forceps biopsy."
15743141|NCT04915833|Diagnostic Test|Colonoscopy with real-time AI assisted automated polyp detection|The same patient will be submitted to a second, same session, computed aided real-time colonoscopy using the DISCOVERY, AI assisted polyp detector. Colonoscopy will be performed by a same-level-of-expertise operator in comparison to the initial procedure. Any polyp or lesion detected with the AI system will be recorded and endoscopically removed and considered as a missed lesion from standard colonoscopy.
15743142|NCT04915820|Dietary Supplement|Ferinject|intravenous iron carboxymaltose
15743143|NCT04915807|Drug|Ramucirumab and paclitaxel|Ramucirumab/paclitaxel as a second-line chemotherapy after May 1, 2018, when health insurance coverage for the combination therapy started
15743144|NCT04915807|Drug|Taxane, irinotecan, or fluoropyrimidine-based single or combined chemotherapy|Taxane, irinotecan , or fluoropyrimidine-based single or combined chemotherapy as a second-line therapy
15743145|NCT04915794|Other|Simulation of preeclamptic pregnancy care|It is an important step in providing safe care to patients, as a learning environment is provided in which environmental risks are minimized with simulation applications. Simulation-based trainings are environments that allow each student to learn, equitable, based on adult learning principles, and open to different learning styles. In these environments, interests and needs are defined together by the learner and the educator. By keeping the experiences of the learner at the forefront, the opportunity is given to learn by doing and is supported with feedback.
15743146|NCT04915781|Other|Not applicable, this is an observational study|Not applicable, this is an observational study
15743147|NCT04915768|Biological|CH505 TF chTrimer|Combined with adjuvants 3M-052-AF and Alum. Combination administered as two 0.5 mL doses via intramuscular injection into deltoid muscle.
15743148|NCT04915768|Biological|3M-05-AF|Combined with CH505 TF chTrimer and Alum adjuvant. Combination administered as two 0.5 mL doses via intramuscular injection into deltoid muscle.
15743149|NCT04915768|Biological|Aluminum hydroxide suspension|Combined with CH505 TF chTrimer and 3M-052-AF adjuvant. Combination administered as two 0.5 mL doses via intramuscular injection into deltoid muscle
15743152|NCT04915742|Behavioral|exercises|The exercise group ha in FTAs 2, each session will be 30 minutes of evil sown in stretching , which made combining relaxation and strengthening exercises therapeutic exercise program for 6 weeks from the online platform will be implemented in the form of group exercise form is planned.
15743153|NCT04915742|Behavioral|thetahealing and exercises|"The exercise group ha in FTAs 2, each session will be 30 minutes of evil sown in stretching , which made combining relaxation and strengthening exercises therapeutic exercise program for 6 weeks from the online platform will be implemented in the form of group exercise form is planned.
~The exercise and Thetahealing treatment group, on the other hand, is planned for 6 weeks , 1 session per week, 30 minutes per session, in addition to the exercise sessions, the first and last sessions to be individual and personalized .
~Applications will be carried out on the online platform."
15743154|NCT04915729|Drug|tenecteplase|tenecteplase
15743155|NCT04915729|Drug|alteplase|alteplase
15743156|NCT04915716|Other|Peripheral blood glucose levels were monitored|Peripheral blood glucose levels were monitored
15743158|NCT04915677|Procedure|Soft tissue augmentation with subepithelial connective tissue graft (SCTG)|After local anesthesia a mesio-distal crestal incision will be performed reaching the alveolar bone. Split thickness dissection performed both buccal and palatal. Subepithelial connective tissue graft will be harvested and inserted beneath the mucoperiosteal flap and stretched buccally and lingually using a modified horizontal mattress suture. The flap margins at the crest will be adapted using single interrupted sutures in order to achieve a primary closure of the flap.
15743159|NCT04915677|Procedure|Soft tissue augmentation with xenogenic volume stable collagen matrix|After local anesthesia a mesio-distal crestal incision will be performed reaching the alveolar bone. Split thickness dissection performed both buccal and palatal. Xenogenic volume stable collagen matrix will be inserted beneath the mucoperiosteal flap and stretched buccally and lingually using a modified horizontal mattress suture. The flap margins at the crest will be adapted using single interrupted sutures in order to achieve a primary closure of the flap.
15743160|NCT04915664|Device|Pessary|Use of Pessary as treatment of POP
15743161|NCT04915651|Device|Gallbladder Cryoablation|Percutaneous cryoablation of the gallbladder.
15743162|NCT04915638|Dietary Supplement|Experimental intervention group with enriched cookies|Enriched cookies containing a micronutrients formula (vitamins, minerals, antioxidants, and omega-3 fatty acids) each day (Monday to Friday).
15743163|NCT04915612|Drug|Gemtuzumab Ozogamicin|Given IV
15743164|NCT04915612|Drug|Liposome-encapsulated Daunorubicin-Cytarabine|Given IV
15743165|NCT04915599|Device|Cooral® mouth cooling device (MCD)|Cooral® mouth cooling device (MCD) to prevent oral mucositis (QM) in patients undergoing radiation therapy for head and neck malignancies
15743166|NCT04915586|Drug|Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg|Intra-pleural Alteplase 16mg with Pulmozyme (DNase) 5mg for total 3 doses within 24 hours
15743167|NCT04915573|Diagnostic Test|Specimen|Sputum will be collected in clean disposable containers
15743168|NCT04915560|Device|Connected T-shirt|Ware of a connected T-shirt
15743169|NCT04915547|Other|Group-Based Exercise|"Each group session will consist of 10 to 18 participants and each exercise session will last 60 minutes and consist of four stages: (1) five minutes warm up (i.e. self-regulated walk); (2) twenty minutes of moderate intensity walking (3) thirty minutes of resistance training for the major muscles of the leg, trunk and arm and balance exercises that progress in difficulty; (4) five-minute cool down period (i.e. self-regulated walk). The exercise intensity will be assessed by one of the following criteria: 1) Resistance training - Point of volitional fatigue. Walking - Somewhat difficult (Borg at 3 to 4). The intensity will be increased according to the ACSM guideline.
~The exercise was set up based on changes in instruments of evaluation of the older peoples as, Berg Balance Scale; Dynamic Gait Index and Timed Up and Go. In addition, exercises commonly used in primary health care groups. The protocol will take place in a gymnasium and will be supervised by a trained instructor."
15743170|NCT04915534|Device|Ambu® AuraGain™ Laryngeal Mask (LM)|Depending on the gender and randomization, the LM is either blocked with 45 cmH2O or with 60 cmH2O cuff pressure. Following general anaesthesia, patients are questioned for postop complications, with focus on postoperative sore throat and hoarseness.
15743171|NCT04915521|Other|erector spina plane block (ESPB) group|"An experienced anesthesiologist performed ESPB in all patients in sitting position bilaterally.
~A linear ultrasound probe (6-13 MHz) was used for ultrasound guidance. Injection was done using in-plane technique. A 22G block needle (100mm, B-Braun, Germany) was inserted 3- cm lateral to the T9 spinous process and advanced in cranio-caudal direction. To separate erector spina muscle from the transverse process, initially 1-2 ml saline was injected; then 20 ml 0.5% bupivacaine and 5 ml 0.2% lidocaine were injected following separation. Diffusion of the drugs in erector spina plane at cranio-caudal line was ensured. No analgesic or sedative was used during the procedure."
15743172|NCT04915508|Drug|Hormone Therapy|Receive hormonal therapy
15743173|NCT04915508|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15743174|NCT04915495|Diagnostic Test|LuViva Advanced Cervical Scan|Multimodal hyperspectral device
15743175|NCT04915482|Drug|Combined use of eltrombopag with low-dose rituximab|The starting dose of eltrombopag is 75mg daily. Before or within 4 weeks after the treatment, rituximab 375mg/m2 will be used once. The dosage will be adjusted according to the results of laboratory examinations and patient tolerance.
15743176|NCT04915482|Drug|The best available therapy|The best available therapy includes but not limited to glucocorticoids, intravenous immunoglobulin, recombinant human thrombopoietin, TPO receptor agonists other than eltrombopag, rituximab monotherapy, immunosuppressants, etc.
15743177|NCT04915469|Other|Standardized enhanced adherence counseling package|A standardized package was developed to support the adherence counsellor and other cadres to ensure provision of quality EAC sessions for children, adolescents and their caregivers. The package included; 1) Orientation and on job mentorship on EAC processes to clinicians, nurses, peer educators and mentor mothers. 2) Using a communication's training curriculum, providers were trained on psychosocial support and communication skills for children and their caregivers. 3) Appointment management was done using appointment dairies or a digital platform that sends patients short message services (SMS) reminders 3 days and 1 day before a scheduled clinic day. 4)Home visits. - All home visits were done according to the EGPAF standard operation procedures (SOPs) drawn from the Kenya National guidelines. 5) Individualized case management -Each EAC client was allocated a case manager who ensured that the barriers to adherence were identified and tackled both at individual and community level.
15743178|NCT04915456|Drug|Systemic Steroid (Prednisolone)|Systemic steroids (Prednisolone) additive to topical steroids (Mometasone fuorate) in a postoperative setting after FESS
15743179|NCT04915456|Other|Placebo|Placebo additive to topical steroids in a postoperative setting after FESS
15743180|NCT04915443|Device|Periotome|"Dental instrument used to perform atraumatic dental extraction.
~After the initial de attachment, the periotome was inserted between the root and the bone parallel to the long axis of the root and pushed apically to the maximum depth that the tissue allowes severing the PDL and leaving it for 10-15 seconds allowing the biomechanical creep to occur.
~This proses is repeated at different points of entries at all the different surfaces of the tooth."
15743181|NCT04915443|Device|Piezotome|"Dental device used for many purposes one of which is performing atraumatic dental extraction.
~An LC2 tip was used for all the procedures and it was inserted between the tooth root and the bone parallel to the long axis of the root and moved in a sweeping motion 3-4mm toward the apex severing the PDL."
15743182|NCT04915430|Other|Training|
15743183|NCT04915417|Radiation|Stereotactic Ablative Body Radiotherapy (SABR)|Patients will receive 27-30 Gy in 3 fractions to the planning target volume (PTV) with a simultaneous in-field boost to the metabolically active areas of the gross tumor volume (GTV) to a maximum of 45 Gy. Patients will be treated every other day.
15743184|NCT04915404|Drug|Berubicin Hydrochloride|Berubicin intravenously infused will be administered at a dose of 7.1 mg/m2 as free base (equivalent to 7.5 mg/m2 Berubicin HCl) as a 2-hour intravenous (IV) infusion once daily for 3 consecutive days followed by 18 days off study drug (each cycle = 21 days).
15743185|NCT04915391|Diagnostic Test|Skin biopsy and blood sample for inflammation markers, RNA and proteins|A skin biopsy will be performed at the baseline visit from which primary cell cultures of fibroblasts and keratinocytes will be obtained. Four to six weeks later a second biopsy on the scar will be performed and analyzed anatomically and pathologically. In addition, at the initial visit, blood samples will be drawn for analysis of inflammation markers, RNA and proteins.
15743186|NCT04915378|Other|hypoxia altitude simulation test (HAST) at 760m|Normobaric hypoxia at a FiO2 of 15.1% will be generated by the Everest Summit II altitude generator (Hypoxico Altitude Training Systems, Bickenbach, Germany) and delivered to the patients face via tubes and a tightly fitted mask. Patients will be seated comfortably in a chair and fitted with a full-face mask equipped with a one-way valve. After a baseline period of quiet rest of 5-10 min with ambient air breathing and installation of equipment, patients will breath the hypoxic air mixture via a tightly fitted facial mask. They will be monitored with a finger-tip pulseoximetry to continuously assess SpO2 and heart rate. After at least 15' and steady-state values of the SpO2 (±1%) for at least 5' arterial blood gases will be drawn from a radial artery and immediately analyzed (RapidPoint 500, Siemens, Zürich, Switzerland).
15743187|NCT04915378|Procedure|High Altitude (3100m)|High Altitude (3100m) exposure for 2 days
15743188|NCT04915365|Drug|Acetazolamide|Acetazolamide (oral capsules @125 mg), starting dose 3 capsules (375 mg), subsequent doses 1 capsule (125 mg) in the morning, 2 capsules (250 mg) in the evening, administered in qualifying participants, during the stay at 3100 m.
15743189|NCT04915365|Drug|Placebo|"Placebo (oral capsules, identically looking as active drug), starting dose 3 capsules, subsequent doses
~1 capsule in the morning, 2 capsules in the evening, administered in qualifying participants, during the stay at 3100 m."
15743192|NCT04915339|Behavioral|Physical activity|The intervention is administrated through a computerized application as prescribed exercises (cognitive or physical). The specific measures that will be used to determine the effect of the intervention are psychological variables (mood, anxiety, well-being, cognitive variables…) and physical ones (Heart rate variability, stress biomarkers, fat and muscle mass, blood circulation…).
15743193|NCT04915339|Behavioral|cognitive training|The intervention is administrated through a computerized application as prescribed exercises (cognitive or physical). The specific measures that will be used to determine the effect of the intervention are psychological variables (mood, anxiety, well-being, cognitive variables…) and physical ones (Heart rate variability, stress biomarkers, fat and muscle mass, blood circulation…).
15743194|NCT04915339|Behavioral|combined physical and cognitive training|The intervention is administrated through a computerized application as prescribed exercises (cognitive or physical). The specific measures that will be used to determine the effect of the intervention are psychological variables (mood, anxiety, well-being, cognitive variables…) and physical ones (Heart rate variability, stress biomarkers, fat and muscle mass, blood circulation…).
15743195|NCT04915326|Procedure|rectal resection|every patients will undergo to the appropriate rectal resection
15743196|NCT04915313|Device|Remote ischemic conditioning (RIC)|RIC is a non-invasive therapy which is performed by automated pneumatic cuffs placed on bilateral arms. The RIC protocol include five cycles of 5-min inflation to 200mmHg and 5-min deflation.
15743197|NCT04915313|Device|Sham remote ischemic conditioning (Sham-RIC)|The Sham-RIC protocol include five cycles of 5-min inflation to 60 mmHg and 5-min deflation by placing automated pneumatic cuffs on bilateral arms.
15743198|NCT04915300|Drug|Apabetalone|Apabetalone 100mg p.o. (tablets) BID for 24 weeks treatment period.
15743199|NCT04915300|Drug|Placebo|Placebo p.o. (tablets) BID for 24 weeks treatment period.
15743200|NCT04915287|Drug|Avatrombopag maleate|"Mean baseline platelet count 40 to less than 50 × 10^9/L: 40mg Avatrombopag QD × 5 days from 10-13 days pre-procedure
~Mean baseline platelet count less than 40 × 10^9/L: 60mg Avatrombopag QD × 5 days from 10-13 days pre-procedure"
15743201|NCT04915287|Biological|Platelet transfusion|Mean baseline platelet count less than 50 × 10^9/L pre-procedure: platelet transfusion if needed
15743202|NCT04915287|Drug|Medicine|Mean baseline platelet count less than 50 × 10^9/L pre-procedure: rhuTPO, rhIL-11, Romiplostim, Eltrombopag, or Lusutrombopag, etc.
15743203|NCT04915274|Other|uses of an application|Patients will be advised that they can still use their QuestOnco handset if they are hospitalized only for a treatment-related toxicity.
15743204|NCT04915261|Behavioral|Lenient Arm Restriction|The study will crossover between either strict arm restriction guidelines for patients or lenient arm restrictions.
15743205|NCT04915261|Behavioral|Strict Arm Restriction|The study will crossover between either strict arm restriction guidelines for patients or lenient arm restrictions.
15743206|NCT04915248|Drug|Daratumumab|"Induction phase planning one course (cycle 1) of daratumumab as single agent followed by 8 courses (cycles 2-9) of daratumumab in combination with bortezomib and dexamethasone (DVd regimen).
~Patients achieving at least a SD after induction will be addressed to the maintenance phase, planning a maximum of 6 cycles (cycles 10-15) of daratumumab as single agent."
15743207|NCT04915248|Drug|Bortezomib|"Induction phase planning one course (cycle 1) of daratumumab as single agent followed by 8 courses (cycles 2-9) of daratumumab in combination with bortezomib and dexamethasone (DVd regimen).
~Patients achieving at least a SD after induction will be addressed to the maintenance phase, planning a maximum of 6 cycles (cycles 10-15) of daratumumab as single agent."
15743284|NCT04914624|Device|acpella®PEP|Continuously instruct patients to perform positive expiratory pressure training 5 days before surgery and one month after surgery, twice a day.
15743208|NCT04915248|Drug|Dexamethasone|"Induction phase planning one course (cycle 1) of daratumumab as single agent followed by 8 courses (cycles 2-9) of daratumumab in combination with bortezomib and dexamethasone (DVd regimen).
~Patients achieving at least a SD after induction will be addressed to the maintenance phase, planning a maximum of 6 cycles (cycles 10-15) of daratumumab as single agent."
15743209|NCT04915235|Behavioral|Algorithm|Algorithm
15743210|NCT04915222|Other|Natural apophyseal glides|Patients received conventional therapy and NAGS with 2-3 hertz (less than 6 repetitions) in 3 sets for 3 weeks. The conventional therapy included hot pack, Neck range of motion exercises, neck strengthening and stabilization exercises. The hot pack is a form of thermo therapywas applied for 10 to 15 minutes and was applied at each visit during 3 sessions per week for total 3 weeks. The strengthening and stabilization exercises are form of therapeutics exercise are prescribed at 15 to 20 times per session for total 3 weeks. Intensity of exercise may rise gradually according to patient tolerance and muscular strength.
15743211|NCT04915222|Other|Cervical manual traction|Patients received cervical manual traction (CMT) along with traditional therapy. Treatment frequency was 3 sessions per week for total three weeks duration. CMT applied was intermittent type traction.8 to 10 kg force was applied at an angle of 20 to 25 degree from horizontal. 5sets of cervical traction are performed. In every set traction is given for 1 minute with rest period of 20 seconds. The total time of traction session was 10 minute. The conventional therapy included hot pack, Neck range of motion exercises, neck strengthening and stabilization exercises. The hot pack is a form of thermo therapywas applied for 10 to 15 minutes and was applied at each visit during 3 sessions per week for total 3 weeks. The strengthening and stabilization exercises are form of therapeutics exercise are prescribed at 15 to 20 times per session for total 3 weeks. Intensity of exercise may rise gradually according to patient tolerance and muscular strength.
15743212|NCT04915209|Other|Narrative interviews|During the workshop, the participants will collectively create a common representation of the patient journey and co-design the envisioning care delivery model that support both social care and medical care.
15743213|NCT04915196|Dietary Supplement|Liposomally-bound Iron|Ferric pyrophosphate microencapsulated in liposomal form is an over the counter natural health product approved by Health Canada and commonly used for iron replacement. If this product is prescribed as part of usual management of iron deficiency and patients consent to participation they will be contacted by telephone survey of gastrointestinal tolerability.
15743216|NCT04915170|Device|Inspiratory muscle training|The device incorporate a unidirectional valve independent of flow to guarantee constant resistance and included a specific pressure setting (in cm H2O)
15743217|NCT04915157|Device|Spinal Cord Stimulator|All patients will receive an implanted spinal cord stimulator.
15743218|NCT04915144|Drug|177Lu-DOTATOC|Subjects will receive 177Lu-DOTATOC PRRT treatment over 4 cycles, each cycle occurs every 8 weeks.
15743219|NCT04915118|Other|Decompensation event|NT-proBNP (N-terminal pro B-type natriuretic) peptide distribution in patients with HFrEF who had a previous decompensation event.
15743220|NCT04915105|Diagnostic Test|Markers data from PBMCs|Prescreen markers from patient individual PBMCs treating with streptococcus and different biologics.
15743221|NCT04915092|Device|CoSIE app|"The app is a mobile phone application compatible with both iOS and Android operating system. Parents are able to register their children and to keep track of their weight status and activities. The app include five themes: child development, physical activity, healthy food, critical situations, BMI.
~Push notification on healthy behaviours, on important event taking place in the province of Reggio Emilia, on food advices based on seasonality and on party tips are constantly delivered by the app."
15743222|NCT04915079|Behavioral|Promoting Resilience in Stress Management (PRISM)|"PRISM is a novel resilience resource intervention consisting of five, one-on-one sessions lasting 30-50 minutes targeting specific teachable resilience skills: stress management, problem solving, goal setting, benefit finding, and meaning making. Sessions will occur at a time convenient to the patient with the first session to occur within 1 week of enrollment either while inpatient or if the patient is discharged, in the outpatient setting in-person or by HIPPA-compliant Zoom. After completion, participants will receive weekly booster contacts (invitations to practice reviewing certain skills) until the occurrence of a planned patient-clinician conversation, facilitated and arranged by study staff during the 5th session. All participants will receive paper worksheets to practice skills between sessions, plus access to a free, digital PRISM app (available only for patients enrolled in PRISM)."
15743223|NCT04915066|Other|Medical data collection|Collection of medical data from patients'medical records
15743224|NCT04915053|Dietary Supplement|ABG+ Black Garlin|Daily tablet intake during three months
15743225|NCT04915053|Dietary Supplement|Crystalline Cellulose|Daily tablet intake during three months
15743226|NCT04915040|Behavioral|Behavioral Activation for Depression|Behavioral Activation (BA) is an effective treatment for depression, and its components may increase social connection. Generally, caregivers are with the older adult care recipient on a regular basis and may be able, with the correct training, to help enhance certain features of the Behavioral Activation treatment, even under pandemic restrictions on social contact. Therefore, we propose to (a) integrate & (b) gather feasibility data for home-based Behavioral Activation + Caregiver
15743227|NCT04915027|Other|a usual follow-up with Rehabkompassen®|Rehabkompassen® is a patient-centered digital graphic tool for capturing the patient's rehabilitation needs in the follow-up after stroke.
15743228|NCT04915027|Other|a usual follow-up with Post-Stroke Checklist, i.e. without Rehabkompassen®|Post-Stroke Checklist consists of eleven questions concerning common and treatable post-stroke problems affecting quality of life.
15743229|NCT04915014|Procedure|sleeve gastrectomy with transit bipartition (SG +TB)|In case of a first intention procedure, a typical sleeve gastrectomy is performed, calibrated on a 36 French bougie, stapling starting 4 to 6 cm from the pylorus. Antecolic gastroileal anastomosis is performed 250 cm from the ileocecal transition, on the antrum using a linear stapler (45-mm gold cartridge) or hand-sewn (at least 3 cm wide on the stomach). Laterolateral enteroanastomosis is performed 120 cm from the ileocecal junction. Thus, alimentary limb is 130cm and common limb 120cm.
15743230|NCT04915014|Procedure|Roux-en-Y gastric bypass (RYGB)|A small gastric pouch (30 cc) is performed. Antecolic gastroileal anastomosis is performed 200 cm from the Treitz junction, using a linear stapler (45-mm gold cartridge) or hand-sewn (at least 3 cm wide on the stomach). Laterolateral enteroanastomosis is performed 50 cm from the Treitz junction. Thus, alimentary limb is 150cm and biliary limb 50cm.
15743231|NCT04914975|Other|Neuromuscular electrical stimulation|The stimulation will be conducted at home or at the SPC for half an hour about 30 minutes before the usual bowel emptying time. Four adhesive electrodes are attached to the abdominal wall for the neuromuscular electrical stimulation. The abdominal muscles are stimulated in such a way that activation occurs, i.e. the muscle alternately contracts and relaxes again. The stimulation sessions will be documented with a defined protocol. In addition, the stool consistency is rated according to the Bristol Stool Form Scale.
15743232|NCT04914962|Other|glazed zirconium lithium silicate|monolithic glazed crown
15743233|NCT04914962|Other|polished zirconium lithium silicate|monolithic polishedcrowns
15743234|NCT04914949|Device|Alio Medical Remote Monitoring System (RMS)|The Alio Medical RMS utilizes a wearable, non-invasive patch (SmartPatch) placed on the AV access of enrolled participants. The SmartPatch gathers physiologic data using optical, mechanical, electrical, acoustic and thermal sensors to collect physiologic data from the participant's vessel related to vascular access health (e.g. volumetric flow and stenosis) and hemodynamic parameters (e.g. Hb/Hct, K+) and transmits it to a bedside hub located in the clinic or participant's home. The Bedside Hub then relays this raw data to the Alio Medical Cloud where it is processed and analyzed utilizing Alio's proprietary algorithms. Data is then accessible to the clinical site and Alio Medical via a web-based portal.
15743235|NCT04914936|Drug|ACP-196|Participants will receive a single oral dose of ACP-196 100 mg capsule on Day 1 of Period 1 in Part 1, Part 2, and Part 3; and on Day 1 of Period 2 in Part 1, Day 5 of Period 2 in Part 2, and Day 1 and Day 9 of Period 2 in Part 3.
15743236|NCT04914936|Drug|Calcium carbonate|Participants will receive a single oral dose of calcium carbonate 1 g tablet on Day 1 of Period 2 in Part 1.
15743237|NCT04914936|Drug|Omeprazole|Participants will receive multiple oral doses of omeprazole 40 mg capsules QD for 5 consecutive days in Period 2 of Part 2.
15743238|NCT04914936|Drug|Rifampin|Participants will receive multiple oral doses of rifampin 600 mg capsule QD for 9 consecutive days in Period 2 of Part 3.
15743239|NCT04914923|Device|Muse|Muse is an EEG headset device created by Interaxxon to track brain waves during mindfulness sessions.
15743240|NCT04914923|Behavioral|Cognitive Behaviour Therapy (CBT)|Cognitive behavioural therapy (CBT), incorporating exposure/response prevention (ERP) and cognitive therapy, is considered the gold-standard treatment for OCD. The efficacy of CBT has been well established, with numerous studies demonstrating that it leads to significant and lasting reduction in OCD symptoms for the majority of completers.
15743241|NCT04914923|Behavioral|Mindfulness-Based Cognitive Therapy (MBCT)|Mindfulness-based interventions (MBIs) including MBCT, are interventions that incorporate formal and informal mindfulness practice in order to treat mental health concerns.
15743242|NCT04914910|Device|Minimed 780G insulin pump|This will be a 14-week, open-label, randomised, parallel-group, controlled trial comparing the efficacy of an AHCL system (MiniMed 780G, Medtronic Diabetes, Northridge, CA) with usual care (i.e., a person's usual insulin pump and CGM/isCGM system). After the 14-week trial period, the control group switches to treatment with the MiniMed 780G system. The intervention group continues with the MiniMed 780G system. Both groups are monitored for another 14 weeks.
15743249|NCT04914884|Diagnostic Test|intraocular fluid detection|This study mainly verified the use of molecular biology technology to detect the changes of VCAM, ICAM-1 and other cytokines, bacteria, viruses, fungi, Toxoplasma gondii IgG in patients' intraocular fluid, including aqueous humor and vitreous humor, so as to timely judge the etiology and progress of endophthalmitis, and provide reference for diagnosis and treatment.
15743250|NCT04914871|Behavioral|Protocol UN Lifeguard Kids in the Tunja version|"The experimental protocol UN Lifeguard Kids in the Tunja version done by the researcher following the guidelines of International organizations such as the American Heart association and European Resuscitation Council.
~The intervention consists of 3 sessions of 60 minutes of theoretical and practical exercises on BLS, developed within the usual class schedule."
15743251|NCT04914871|Behavioral|Educational session accident prevention and wound management|It will be provided to the control group
15743252|NCT04914858|Other|Education|Its validity and reliability is a reliable scale in Turkey
15743253|NCT04914845|Drug|KPT-9274|KPT-9274 is a first-in-class orally bioavailable, non-competitive, small molecule, dual modulator of p21 protein (Cdc42/Rac)-activated kinase 4 (PAK4) and nicotinamide phosphoribosyltransferase /PBEF/visfatin (NAMPT). NAMPT is the rate-limiting enzyme in the metabolic scavenging pathway that utilizes nicotinamide to replenish nicotinamide adenine dinucleotide (NAD), an essential metabolic cofactor and second messenger. Recent investigations have shown that in in vitro and in vivo models, NAMPT is uniquely essential for relapsed or refractory AML stem cells. Targeting relapsed AML stem cells, through targeting of NAMPT, may allow for a promising therapeutic opportunity for patients with relapsed or refractory AML.
15743254|NCT04914832|Biological|AZD1222|AZD1222 is a recombinant replication-defective chimpanzee adenovirus vaccine expressing the SARS-CoV-2 S surface glycoprotein.
15743255|NCT04914819|Behavioral|Online Behavioral Weight Loss Program|Participants will be enrolled in a 16-week online behavioral weight loss program based on the Diabetes Prevention Program (DPP). The program involves weekly brief videos, a self-monitoring platform, automated feedback, and access to a health coach.
15743256|NCT04914819|Behavioral|Virtual weigh-in|Participants will be sent a digital scale and will be asked to complete a virtual weigh-in at home at the start of the study and again after 16 weeks.
15743257|NCT04914793|Device|Antimicrobial prescribing guideline mobile phone application (MicroGuide)|This session is given to all hospital doctors in all study hospitals at the start of the intervention period of each paired hospital. All participating hospitals will join AMS knowledge survey three times during the study period (1st time= at the start of the project, 2nd time= before entering to the intervention period and 3rd time= at the end of the project).
15743258|NCT04914780|Behavioral|Education|Education intervention with mobile application for 4 weeks
15743259|NCT04914767|Drug|Nigella|"The patient will receive a study treatment containing 100 capsules:
~One capsule every two hours for the first three days.
~From the fourth day, the patient will take one capsule, three times a day for 12 days."
15743260|NCT04914767|Drug|Placebo|"The patient will receive a study treatment containing 100 capsules:
~One capsule every two hours for the first three days.
~From the fourth day, the patient will take one capsule, three times a day for 12 days."
15743261|NCT04914741|Drug|Rituximab|Rituximab 375 mg/m^2 administered by IV infusion on Day 1 of every 21-day cycle
15743262|NCT04914741|Drug|Cyclophosphamide|Cyclophosphamide 750mg/m^2 administered by IV infusion on Day 1 of every 21-day cycle
15743263|NCT04914741|Drug|Doxorubicin|Doxorubicin 50mg/m^2 administered by IV infusion on Day 1 of every 21-day cycle
15743264|NCT04914741|Drug|Vincristine|Vincristine 1.4mg/m^2 administered by IV infusion on Day 1 of every 21-day cycle
15743265|NCT04914741|Drug|Prednisolone|Prednisolone 100mg orally on Days 1-5 of every 21-day cycle
15743266|NCT04914741|Drug|Glofitamab|Glofitamab will be administered by IV infusion as per the schedule specified in the respective arm
15743267|NCT04914741|Drug|Polatuzumab vedotin|Polatuzumab 1.8mg/kg administered by IV infusion on Day 1 of every 21-day cycle
15743268|NCT04914728|Procedure|mini-invasive lumbar arthrodesis|"The mini-invasive posterior approach is performed using a trans-muscular Wiltse approach. Pedicle screws, neurological decompression and intersomatic cage placement are performed.
~The mini-invasive anterior approach is performed via a left retroperitoneal pararectal approach. After complete discectomy, an intersomatic cage stabilised by a screwed plate will be placed."
15743269|NCT04914715|Device|Non-invasive High Frequency Oscillatory Ventilation|We are planning to use (Medin-CNO) for non-invasive ventilation. This machine has option to deliver NHFOV with frequency of 5-20 (300-1200 breathe/min), Amplitude of 1-10, flow1-17.5 liter/min, fiO2 21-100% and integrated pressure triggered sensitivity option.
15743270|NCT04914715|Device|Conventional Invasive Ventilation|Invasive ventilation will be started following endotracheal intubation, mode will be selected as Synchronized Intermittent Mandatory ventilation (SIMV) with rate of 25-60 breath/min, flow of 8 liter, positive inspiratory pressure (PIP) of 14-25, Positive end expiratory pressure (PEEP) 4-5, fio2 of 21-40.
15743271|NCT04914702|Device|Everion®|The Everion® is an on-skin wearable devices measuring vital signs. It will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear all the time, with exception of the time needed for the patients' hygiene.
15743272|NCT04914702|Device|CORE®|The CORE® is an on-skin wearable devices measuring vital signs. It will be given to the participants for the duration of 2 weeks (fourteen days) with the instruction to wear all the time, with exception of the time needed for the patients' hygiene.
15743273|NCT04914689|Other|Internal focus of attention feedback|Participants will complete 12 sessions over a 3-week period of functional movement retraining while receiving mirror feedback. Participants will be instructed to perform each functional task in a manner that keeps their knee in line with their toes.
15743274|NCT04914689|Other|Visual internal focus of attention feedback|Participants will complete 12 sessions over a 3-week period of functional movement retraining while receiving visual feedback via laser. Participants will be instructed to perform each functional task in a manner that does causes the laser to move up and down but not side-to-side.
15743275|NCT04914689|Other|Auditory external focus of attention feedback|Participants will complete 12 sessions over a 3-week period of functional movement retraining while receiving auditory feedback. Participants will be instructed to perform each functional task in a manner that does not cause the auditory tool to elicit a noise.
15743276|NCT04914676|Drug|Cytarabine|Subjects on this arm will prospectively receive consolidation therapy with cytarabine. Subjects will be treated with 1000 mg/m2 cytarabine intravenously every 12 hours on Days 1-3 of each consolidation cycle. Subjects will receive up to four consolidation cycles.
15743277|NCT04914676|Drug|Cytarabine|Subjects on this arm will have received consolidation therapy with cytarabine between 2/1/2017 and 2/1/2019. Subjects will have received 1000 mg/m2 cytarabine intravenously every 12 hours on days 1, 3, and 5 of each consolidation cycle and will have received up to 4 consolidation cycles.
15743278|NCT04914663|Behavioral|Exercise training|Supervised exercise training performed in small groups over 12 weeks while patients undergo chemotherapy for breast cancer.
15743279|NCT04914650|Other|Telerehabilitation|Providing multidisciplinary rehabilitation to individuals with spinal cord injury or brain injury using virtual conference methods
15743280|NCT04914637|Procedure|Cervical interlaminar epidural steroid injection|Fluoroscopy-guided cervical interlaminar epidural steroid injection will be administered to patients with chronic neck pain due to cervical disc herniation. The injection area is cleaned 3 times with an antiseptic solution and covered with a sterile cloth. Local anesthesia with 2 cc 3% prilocaine will be applied to the skin and subcutaneous tissues in the area of interest. Under fluoroscopy guidance, the needle is advanced into the C7-T1 intervertebral disc level. With the help of the loss of resistance technique, it is understood that the needle is in the epidural space, and second control is provided by administering contrast material. After the confirmation of needle place is done, a mixture of 12 mg dexamethasone, 1 cc 2% lidocaine, 1 cc saline is injected. The patient is taken to the rest room after the procedure and followed up for any complications.
15743281|NCT04914637|Procedure|Dry needling|Dry needling will be applied to the active trigger points for the patients in this group. After cleaning the area of interest with an antiseptic solution, dry needling will be applied with the fast-in/fast-out technique for the active trigger point. During needle maneuvers, local contractions (local twitch response-LTR) are obtained and rapid needle movements are continued until the contractions end. Afterwards, the needle is removed and compression is applied to ensure hemostasis in the relevant area.
15743282|NCT04914637|Procedure|Sham dry needling|Although the method of intervention is like dry needling, the only difference is that the blunt end of the needle is used and it does not penetrate the skin.
15743287|NCT04914598|Drug|ENDOSTAR，cisplatin|After sufficient puncture and drainage or drainage, use Endo® (45mg/time in thoracic cavity, 60mg/time in abdominal cavity) + cisplatin (40mg/time) intracavitary injection, administration on 1, 4, and 7 days, 3 times as a course of treatment
15743288|NCT04914598|Drug|Placebo , cisplatin|Placebo , cisplatin
15743289|NCT04914572|Other|Therapeutic rainforest mindful walking|A two-kilometer trail curated by the National Parks Board, Singapore. The walk will be led by Mindfulness Practitioner who volunteered to be guides for this study.
15743290|NCT04914572|Other|Therapeutic rainforest walk|A two-kilometer trail curated by the National Parks Board, Singapore. The walk will be led by volunteer guides recruited by the research team.
15743291|NCT04914572|Other|Campus Green walk|A two-kilometer trail curated by the Office of Facility Management, NUS. The walk will be led by volunteer guides recruited by the research team.
15743292|NCT04914559|Other|Oral nutrition supplement - control|Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat intended for use as supplemental nutrition.
15743293|NCT04914559|Other|Oral nutrition supplement - test|Drink 1 cup of liquid nutrition product that contains protein, carbohydrate and fat designed for people living with diabetes and intended for use as supplemental nutrition.
15743294|NCT04914546|Drug|LY3819469|Administered SC.
15743295|NCT04914546|Drug|Placebo|Administered SC.
15743296|NCT04914533|Device|Luminance RED Low Level Laser Therapy Device|Low Level Laser Therapy (LLLT) sometimes known as Low Level Light Therapy or Photobiomodulation (PBM) is a low-intensity light therapy. The effect is photochemical not thermal. The Luminance RED Device is specifically designed to make it easy to issue LLLT to canker sores.
15743299|NCT04914507|Device|Anterior Vertebral Body Tethering|Subject will receive anterior vertebral body tethering surgery.
15743300|NCT04914455|Diagnostic Test|Echocardiography and transhepatic inferior vena cava assessment using ultrasound.|"For all participant :
~Inferior vena cava diameter will be measure before and after fluid expansion 'which administration will be decided by a physician other that the investigator).
~Stroke volume using primarily VTI in TTE or a cardiac output monitoring device (Swan ganz catheter (Edwards life science), EV 1000 (edwards life science), PiCCO(Getinge))
~Absence of significant pericardial effusion of hematoma
~Whenever possible:
~Subcostal measurement of IVC, ejection fraction, cardiac outcput, mitral E, A and E' waves, TAPSE, Tricupid S' wave, Right ventricle fractional area change.
~venous congestion assesment : hepatic vein, portal vein and renal vein Doppler to define the VEXUS Score;"
15743301|NCT04914442|Diagnostic Test|Microscopic examination|All the studies cases are microscopically examined using the ordinary stains (hematoxylin and eosin) then the eosinophilic infiltration are counted in 10 high power field manually
15743304|NCT04914416|Dietary Supplement|Verum T1|Verum T1 is a placebo: microcristalline cellulose. Daily dosage is 1000 mg in 3 capsules.
15743305|NCT04914416|Dietary Supplement|Verum T2|Verum T2 is a 11500AAIU/g white kidney bean extract. Daily dosage is 1000 mg in 3 capsules.
15743306|NCT04914416|Dietary Supplement|Verum T3|Verum T3 is a 11500AAIU/g white kidney bean extract. Daily dosage is 565 mg in 3 capsules
15743307|NCT04914416|Dietary Supplement|Verum T4|Verum T4 is a 17500AAIU/g white kidney bean extract. Daily dosage is 1000 mg in 3 capsules
15743308|NCT04914416|Dietary Supplement|Verum T5|Verum T5 is a 17500AAIU/g white kidney bean extract. Daily dosage is 371 mg in 3 capsules
15743309|NCT04914416|Dietary Supplement|Verum T6|Verum T6 is a 34200AAIU/g white kidney bean extract. Daily dosage is 1000 mg in 3 capsules
15743310|NCT04914416|Dietary Supplement|Verum T7|Verum T4 is a 34200AAIU/g white kidney bean extract. Daily dosage is 512 mg in 3 capsules
15743311|NCT04914416|Dietary Supplement|Verum T8|Verum T8 is a 34200AAIU/g white kidney bean extract. Daily dosage is 190 mg in 3 capsules.
15743312|NCT04914416|Dietary Supplement|Verum T9|Verum T9 is a polyphenol mix extract ( olive leaf, and blackcurrant extract). Daily dosage is 1000 mg in 3 capsules
15743313|NCT04914416|Dietary Supplement|Verum T10|Verum T10 is a polyphenol mix extract ( olive leaf, and blackcurrant extract). Daily dosage is 500 mg in 3 capsules
15743314|NCT04914416|Dietary Supplement|Verum T11|Verum T11 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract). Daily dosage is 900 mg in 3 capsules
15743315|NCT04914416|Dietary Supplement|Verum T12|Verum T12 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and blackcurrant extract). Daily dosage is 600 mg in 3 capsules
15743316|NCT04914416|Dietary Supplement|Verum T13|Verum T13 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and/or blackcurrant extract) with white kidney bean extract. Daily dosage is 1000 mg in 3 capsules.
15743317|NCT04914416|Dietary Supplement|Verum T14|Verum T14 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and/or blackcurrant extract) with white kidney bean extract. Daily dosage is 900 mg in 3 capsules.
15743318|NCT04914416|Dietary Supplement|Verum T15|Verum T15 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and/or blackcurrant extract) with white kidney bean extract, Zinc, and, black currant leaf extracts. Daily dosage is 1000 mg in 3 capsules.
15743319|NCT04914416|Dietary Supplement|Vaerum T16|Verum T16 is a polyphenol mix extract ( olive leaf, pomelo, pomegranate, and/or blackcurrant extract) with white kidney bean extract, and Zinc. Daily dosage is 1000 mg in 3 capsules.
15743320|NCT04914403|Biological|UMC119-06-05|Cohort 1: Low does of UMC119-06-05 Cohort 2: High does of UMC119-06-05
15743321|NCT04914390|Drug|AT regimen|Doxorubin 60mg/㎡ d1 or Epirubicin 75mg/㎡ d1 and Nab-paclitaxel 260mg/㎡ d1 of Cycles 1-6 (Q3W) of the neoadjuvant phase of the study; IV injection.
15743322|NCT04914390|Drug|Tislelizumab|200mg on d1 of Cycles 1-6 (Q3W) of the neoadjuvant phase of the study; IV injection.
15743323|NCT04914390|Drug|Anlotinib|8mg on d1-14 of Cycles 1-5 (Q3W) of the neoadjuvant phase of the study; po. Arotinib is a small molecule multi-target TKI, which exerts its effect by inhibiting angiogenesis, a critical component of tumour growth and metastasis.
15773301|NCT04668456|Drug|Normal saline|either subtenon or iv
15743324|NCT04914377|Drug|TQ Formula/Tab|TQ Formula will be administered as an oral dose daily. The dose planned in this study is 3 g per day (3 500mg capsules to be taken twice daily).
15743325|NCT04914364|Other|Balance assessments|There is no formal intervention in this study. The investigators will only be completing balance assessments with no follow-up visit.
15743326|NCT04914351|Drug|HY-0102|Multiple dose cohorts, 60 minute IV infusion, every two weeks, 28 days as a cycle
15743327|NCT04914338|Other|Health Promotion|Participate in MDT-intervention
15743328|NCT04914338|Other|Quality-of-Life Assessment|Ancillary studies
15743329|NCT04914338|Other|Questionnaire Administration|Ancillary studies
15743330|NCT04914325|Combination Product|peek|After tooth preparation, adequate 2ry Impression using non aqueous elastomeric impression materials and bite registration will be taken. 5. Fabrication of the temporary restoration using composite resin temporary material and cemented using non Eugenol Zinc Oxide temporary cement. 11.a.iii. Fabrication and cementation of restoration: Bio-HPP will be supplied in the form of discs to fabricate crown core by CAD/CAM technology then veneered with two veneering techniques; the CAD/ CAM and the manual technique using the visio.lign system of appropriate shade. The finished Bio HPP crown will be cemented by adhesive resin cement according to manufacturer instruction
15743331|NCT04914312|Dietary Supplement|Maqui berry/omeg-3 fatty acids|2 capsules BID per day containing a total of 600 mg of Maqui extract; 4 capsules per day supplying a total of 2000 mg EPA and 1000 mg DHA
15743332|NCT04914312|Dietary Supplement|Placebos|4 olive oil soft gelatin capsules and inert two-piece capsules containing maltodextrin
15743333|NCT04914299|Behavioral|"App-based positive intelligence intervention"|"A 6 weeks App-guided and support-group based positive intelligence cognitive behavioral intervention in addition to standard prenatal and postnatal care"
15743334|NCT04914299|Behavioral|Standard of care|Standard prenatal and postnatal care(Providing psychoeducation and referral to psychotherapy or pharmacotherapy based on participant's symptoms).
15743335|NCT04914286|Drug|GFH018|Subjects are planned to be dosed in oral GFH018 tablets twice daily for a continuous 14 days in a 28 days cycle (7days on 7days off may be tested based on available data from phase I dose escalation study of single agent). the starting dose of GFH018 will be derived from the maximum safe dose explored in rom phase I dose escalation study of single agent.
15743336|NCT04914286|Drug|Toripalimab|Subjects are planned to be dosed at 3 mg/kg Toripalimab as an intravenous infusion once every 2 weeks.
15743337|NCT04914273|Drug|Inhalation Spray|400 mcg salbutamol administered per metered dose inhaler
15743338|NCT04914273|Drug|Tablet|8 mg salbutamol administered per tablet for ingestion
15743339|NCT04914260|Other|Questionnaire|The participants will have to fill in an on-line questionnaire regarding quality of life, their level of knowledge of the rehabilitation through sport program and their level of satisfaction toward this program.
15743340|NCT04914247|Drug|Selexipag|
15743341|NCT04914234|Drug|Atenolol Succinate Oral Tablet|Atenolol 50 mg
15743342|NCT04914234|Drug|Metoprolol Succinate Oral Tablet|Metoprolol 100 mg
15743343|NCT04914221|Drug|JLP-2002|administration of JLP-2002
15743344|NCT04914221|Drug|Comparator|administration of comparator
15743345|NCT04914208|Device|DIY face mask|Participants are wearing a DIY face mask for 4 hours (beginning between 8 and 9 a.m.). The correct fit of the face mask is checked by the study officials and corrected if necessary.
15743346|NCT04914208|Device|Surgical face mask|Participants are wearing a surgical face mask for 4 hours (beginning between 8 and 9 a.m.). The correct fit of the face mask is checked by the study officials and corrected if necessary.
15743347|NCT04914208|Device|FFP2 respirator mask|Participants are wearing a FFP2 respirator mask for 4 hours (beginning between 8 and 9 a.m.). The correct fit of the face mask is checked by the study officials and corrected if necessary.
15743348|NCT04914208|Other|Waiting for 4 hours without wearing a mask|Participants do not wear any face mask for 4 hours (beginning between 8 and 9 a.m.).
15743349|NCT04914208|Other|Use of fluoridated toothpaste|Participants use fluoridated toothpaste.
15743350|NCT04914195|Drug|Leuprolide Acetate 3.75 MG/ML|Leuprolide Acetate/ Leuprorelin is a depot injection administered as a subcutaneous injection once every month.
15743351|NCT04914182|Radiation|LASER|Laser will be applied in specific points for perineal lacerations.
15743352|NCT04914182|Radiation|CONTROL|"A control group of sham laser will create for the patients the impression that laser is being played, with the lights of the instrument of on mode turned on, without biological effects."
15743353|NCT04914169|Device|ICRS|The ICRS enables a stationary bike to automatically adjust the pedaling resistance (i.e. training intensity) according to the subject's heart rate. The training intensity is determined by monitoring whether the subject is able to maintain a 50-70 cycles/min cadence with 60-80% HRR. Subjects heart rate was detected by a wearable device for heart rate, synching with the stationary bike.
15743354|NCT04914156|Other|Genetic based dietary advice|Genetic test results for 70 genes relating to nutrition and physical activity will be used in conjunction with participants current dietary intake to create nutrition advice tailored to each individual.
15743355|NCT04914156|Other|Personalised population based dietary advice|Current dietary intake will be compared with current best practice population-based sports nutrition dietary advice to create tailored nutrition advice for each of the participants
15743356|NCT04914143|Other|broken Ganoderma lucidum spore powder|The experimental group was treated with broken Ganoderma lucidum spore powder after chemotherapy
15743357|NCT04914143|Other|placebo|the control group was treated with placebo after chemotherapy
15743358|NCT04914130|Other|Study specific testing procedures|Study specific procedures includes blood sampling, neurocognitive testing, respiratory questionnaire, brain MRI for MRI substudy group, lumbar puncture for MRI substudy group, etc
15743360|NCT04914104|Behavioral|Mindfulness Training - Headspace App|The intervention group will receive free access to the mobile app Headspace and directed to access the app three times a week for at least 15 minutes.
15743390|NCT04913818|Other|Control arm (Usual care)|Active Comparator: Usual Care Activities will be provided by the elderly community center such as dementia or caregiver supporting service. They will be allowed to use the regular service provided such services are not related to physical activity or exercise training
15743361|NCT04914091|Other|Semi-structured interviews and self-administered questionnaires|Interviews and questionnaires will be performed before administration of CAR-T cells, 3 month after and 6 month after, and will last 60 minutes each time. Semi-structured interview using pre-established questionnaires will be completed with a hospital pharmacist, concerning the patient's perception of his family, socio-professional environment, his knowledge of his illness and his treatment, the consumption of prescribed drugs outside the hospital, self-medication, complementary alternative therapies including herbal medicine. Seven self-administered questionnaires will be completed, concerning quality of life, Assessment of Cancer Treatment-Lymphoma, Beliefs about Medicines, Brief Illness Perception, satisfaction with medication, perceived social support scale, and on Health Literacy.
15743362|NCT04914078|Drug|Mepolizumab 100 MG|The patients will treated with subcutaneous Mepolizumab at 100 mg every 30 days. Patients will be recruited among those eligible to Mepolizumab treatment according to the Italian Medicine Agency (AIFA; Agenzia Italiana del Farmaco) guidelines who will accept to participate to the study. In particular inclusion criteria will be: severe (Step 4 and 5 GINA) asthma with at least blood eosinophilic count above 300 cells/mcl at least once in the previous year and ≥150 cells/mcl in the absence of systemic corticosteroid treatment before biological treatment initiation. In addition, one of the following conditions will be required: 1) ≥2 exacerbations in the previous year despite appropriate inhaled treatments or 2) the need for systemic corticosteroids on top of inhaled treatment for at least 6 months in the previous year.
15743363|NCT04914065|Other|Regular care in the surgery intensive care unit|"Part 1: Two arms(muscle thickness observation):
~Inspiratory muscles: diaphragm
~Anti-gravity muscles: rectus femoris and the vastus intermedius
~Part 2: Predictors of short-term and long-term goals in the ICU
~Short-term goal: successful ventilator weaning in the ICU- pass weaning profile without re-intubation in the hospital
~Long-term goal- Quality of life after hospital discharge: SF-36 (Taiwan version)"
15743364|NCT04914052|Other|Filming facial expressions|Study participants' facial expressions will be videoed by a camera placed in front of the patient's bed during their stay in the post anesthesia care unit.
15743365|NCT04914039|Combination Product|Combination Product|Cases of brain death confirmed by the classic brain death confirmation test
15743366|NCT04914039|Other|NO CTA examination|NO CTA examination
15743367|NCT04914026|Other|Biomarker analysis|Blood collection. Blood samples will be collected at diagnosis, during surveillance, during treatment and every 3-6 months
15743368|NCT04914013|Other|no intervention|no intervention
15743369|NCT04914000|Behavioral|Self-help Materials|Self-help booklet targeted by cancer type to increase smoking cessation motivation
15743370|NCT04913987|Device|Stryker Triathlon total knee replacement|Knee arthroplasty using a standard care total knee.
15743371|NCT04913987|Device|Zimmer Biomet Persona Partial Knee unicondylar knee replacement|Knee arthroplasty using the Zimmer Biomet Persona Partial Knee (PPK).
15743372|NCT04913974|Procedure|Uni-condylar knee arthroplasty|Surgical replacement of medial compartment of arthritic knee with an implant
15743373|NCT04913961|Other|Supine Daoyin|During hospitalization, the rehabilitation group will receive conventional western medicine treatment and supine guidance therapy which consists of training and patient education. They will be evaluated with some tests for the study
15743374|NCT04913961|Other|western medicine conventional therapy|The control group will get the western medicine conventional therapy with some additional tests for the study.
15743375|NCT04913948|Other|No intervention|No intervention
15743376|NCT04913935|Diagnostic Test|Muscle-Skeleton Ultrasonography|postero-anterior radiography
15743377|NCT04913922|Drug|Azacitidine Injection|s.c. 75 mg/m2 BSA for 7 days
15743378|NCT04913922|Drug|Nivolumab|480 mg i.v.
15743379|NCT04913922|Drug|Relatlimab|80-160mg i.v.
15743380|NCT04913909|Dietary Supplement|Effects of an oral probiotic or placebo use on oral microbiota and glycemic index in Type 2 diabetic patients|"The participants were randomized to the interventional groups, probiotic or placebo, by the diabetes nurse. During the intervention period of 30 nights, the participants were asked to let one Dentoblis™ or placebo lozenge slowly melt in their mouth for one minute before going to bed and after tooth brushing. Dentoblis™, as a test lozenge, contains 4x109 CFU/g S. salivarius M18 strain isolated from a healthy oral microbiota and has been utilized as oral probiotic inhibiting dental caries-causing pathogens.
~The placebo is indistinguishable in form, size, color, and taste from the probiotic lozenge, but contains no bacteria. Placebo and probiotic lozenges were equivalent to 810 mg each and containing same amount of xylitol. Both were provided by the manufacturer, Bluestone Pharma GmbH, Baar, Switzerland, in equal white containers boxes, separated by production code. Neither the investigators nor the subjects were aware of the contents of the lozenges except for the research nurse."
15743381|NCT04913896|Drug|PD-1 inhibitor|SOX regimen for 3 cycles and/or PD-1 inhibitor before surgery
15743382|NCT04913870|Drug|Angiotensin Receptor Blockers|Angiotensin Receptor Blockers treatment for 2 years.
15743383|NCT04913870|Other|Placebo|Placebo administration for 2 years.
15743384|NCT04913857|Behavioral|24-week SUDOKU Training Programme|12-week face-to-face training session and a 12-week facilitated self-practice
15743385|NCT04913857|Other|Control Arm (wait-list)|wait-list comparison group will receive the same program upon completion of the 6-month posttest evaluation on study outcomes
15743386|NCT04913844|Other|Physical performance tests and observational assessments|There will be no interventions. Physical performance tests and observational assessments will be conducted.
15743387|NCT04913831|Drug|Cerebrolysin|Cerebrolysin 20ml + physiological saline 80ml, 8-35 days, once/day, intravenous administration
15743388|NCT04913831|Drug|Placebo|physiological saline 100ml, 8-35 days, once/day, intravenous administration
15743389|NCT04913818|Behavioral|BUDPA Program|The overall program includes 12 weekly 1-hour training class. Each session starts with a 10-minute warm-up period using stretching exercise and stationary mobilizing exercise for trunk and limb joints at both upper and lower bodies (e.g. shoulders, elbows, wrists, hips, knees and ankles), and followed by a session of four to six selected partnering exercise, with duration increase gradually from 20 minutes to 40minutes in four weeks' time. The Borg Rate of Perceived Exertion (Borg RPE) will be used to monitor the exercise intensity. The Research assistant will explain the Borg RPE scale to the subjects and instruct them to speed up or slow down their movements. The training session will end with a 10-minute cool down session with walking exercise and stationary trunk and limb mobilizing exercise involving joints of shoulders, elbows, wrists, hips, knees, and ankles.
15743394|NCT04913792|Device|ZXR00|This prospective comparative study included 60 eyes undergoing cataract surgery with implantation of an extended range of vision IOL.(Abbott Medical Optics, Inc.)
15743395|NCT04913779|Drug|Anti-SARS-CoV-2|Purified F(ab')2 Fragments of Equine hyperimmune Serum with anti-SARS-CoV-2 neutralizing activity (titer 1/5120 or higher)
15743396|NCT04913779|Drug|Placebo|Administration of 10 ml of a control-solution without neutralizing activity against SARS-CoV-2, administered in slow intravenous infusion (10 ml diluted in 100 ml of saline solution, administered over 50 to 60 minutes in slow drip), produced by ANLIS-Malbrán, administered twice (time 0 when incorporated into the study -initial dose- and at 48 hours -second dose-).
15743397|NCT04913766|Behavioral|Problem Management Plus|Five session psychological intervention focusing on problem management skills.
15743398|NCT04913766|Behavioral|Services as Usual|Mental health services provided by a mental health specialists according to their standard practices of care
15743399|NCT04913753|Procedure|CBEU|Patients in the control group will have bacterial culture and double J removal will be performed as usual. .
15743400|NCT04913753|Procedure|No CBEU|Patients in the experimental group will have bacterial culture and double J removal will be performed as usual. .
15743401|NCT04913740|Other|Ointment and dressing for external use|"pay attention to the protection of exposed skin, so that it is local dry.
~Do a good job of facial moisturizing work before work use moisturizing ointment, more durable and non-irritating cream or emulsion, such as vitamin E cream, petroleum jelly, to do a good job of moisturizing work.
~Use appropriate dressing to avoid direct contact between the mask and the skin, and select the appropriate type of protective device; Reduce friction by applying foam patches, hydrocolloidal dressings, and empleters to the hair area. However, it should be noted that it must be confirmed that airtightness is good and that the protective effect is still the primary purpose of the medical staff.
~After work, avoid using irritants to clean the face, and massage local skin with skin moisturizer; (5) If severe skin damage occurs, treat it as prescribed by the doctor"
15743402|NCT04913727|Diagnostic Test|Cardiac magnetic resonance imaging before the procedure|CMR image acquisition with previously mentioned analysis
15743403|NCT04913727|Procedure|Transcatheter mitral edge-to-edge repair.|Included patients will undergo Transcatheter mitral edge-to-edge repair.
15743404|NCT04913714|Behavioral|3-month radio intervention on infant vaccination|Radio intervention comprising 10-minute drama, 10-minute discussion of the drama by trained health extension workers and 30-minute phone-in from listeners
15743405|NCT04913701|Other|Observation group 1|Subjects will be followed with 3 swabs and serological test
15743406|NCT04913688|Procedure|bedside ultrasound performed group|If deep vein thrombosis (DVT) is suspected among patients who visit the emergency department, an emergency physician performs bedside ultrasound of lower extremities to the patients agreed to participate in this study. The patients also are examined duplex ultrasound by radiologist.
15743410|NCT04913662|Procedure|Pressurized Intraperitoneal Aerosol Chemotherapy|Aerosolization of chemotherapic agent for intraperitoneal chemotherapy
15743411|NCT04913649|Drug|Ferric Derisomaltose 100 MG/ML|Postoperative treatment with a single dose IVI (ferric derisomaltose), with a dose of 20mg/kg in approximately 60 minutes.
15743412|NCT04913649|Drug|Sodium chloride|Postoperative treatment with a single dose NaCl 0.9% in approximately 60 minutes.
15743413|NCT04913623|Procedure|Hip Replacement|The hip replacement surgery is when a damaged hip is replaced with artificial one
15743414|NCT04913610|Drug|ABBV-4083|Oral Capsule
15743415|NCT04913610|Drug|Placebo for ABBV-4083|Oral Capsule
15743416|NCT04913610|Drug|Albendazole|Oral encapsulated tablets
15743417|NCT04913610|Drug|Placebo for Albendazole|Oral Capsule
15743418|NCT04913610|Drug|Placebo for Ivermectin|Oral Capsule
15743419|NCT04913610|Drug|Ivermectin|Encapsulated Oral Tablet
15743420|NCT04913584|Behavioral|Cognitive Behavioural Therapy|Cognitive Behavioral Therapy 9 weekly 2-hour online group CBT sessions delivered by trained lay peers.
15743421|NCT04913571|Drug|Eribulin|Eribulin
15743422|NCT04913571|Drug|Tislelizumab|Tislelizumab
15743423|NCT04913558|Other|Aerobic exercise|"The exercise will be performed by using the treadmill as the following:
~- The first stage (warming up): It consists of 5 minutes warming up with the treadmill speed set at 1.0 mile per hour.
~- The second stage (active stage): It consists of 20 minutes with the treadmill speed set at 3.0 miles per hour.
~- Third stage (cooling down): It consists of 5 minutes of cooling down with the treadmill speed set at 1.0 miles per hour."
15743424|NCT04913558|Other|Traditional Treatment|"General advice for reducing fatigue and stress
~Fluid and diet advice
~Carrying the Baby
~While Breastfeeding in a sitting position
~Selecting Clothing"
15743425|NCT04913545|Diagnostic Test|using salivary miRNA (412,512)|quantitative real time polymerase chain reaction to detect the salivary miRNAs 412,512) to indicate the malignant transformation in potientially malignant oral lesions.
15743426|NCT04913532|Radiation|Hypofractionation with simultaneous integrated boost|Hypofractionation with simultaneous integrated boost
15743427|NCT04913519|Drug|TDM-105795|TDM-105795 topical solution
15743428|NCT04913519|Drug|Placebo|Placebo for TDM-105795 topical solution
15743429|NCT04913506|Other|Group Mirror|For 30 minutes, ROM exercises will be applied to the solid upper extremity in all directions in front of a real mirror by the practitioner. (3 weeks, 5 days a week, 15 sessions in total)
15743430|NCT04913506|Device|Group NMES|NMES will be applied to the hemiplegic arm(deltoid, elbow extensors and forearm) for 30 minutes by the practitioner (3 weeks, 5 days a week, 15 sessions in total)
15743431|NCT04913506|Other|Group Mirror+NMES|The practitioner will be synchronized with visual or auditory stimuli, and ROM exercises in all directions in front of the real mirror for 30 minutes, and NMES therapy for 30 minutes on the paretic upper extremity will be applied together. (3 weeks, 5 days a week, 15 sessions in total)
15743468|NCT04913311|Drug|Immune Checkpoint Inhibitor|Receive CPI per standard of care
15743432|NCT04913493|Procedure|Cytocam-IDF|Patients receive an extra medical imaging test perioperatively with the Cytocam-IDF
15743433|NCT04913480|Drug|Durvalumab|Durvalumab 750mg intravenous infusion once every 2 weeks for 26 cycles
15743434|NCT04913480|Radiation|Stereotactic body radiation therapy|Stereotactic body radiation therapy of 27.5Gy to 50Gy in 5 fractions to the liver tumors delivered over 5 to 14 days.
15743438|NCT04913454|Other|40 Hz multi-sensory (auditory + visual) stimulation and cognitive training|40 Hz multi-sensory (auditory + visual) stimulation and cognitive training (1 hour/day, per 5 days/week, for a total of 8 weeks)
15743439|NCT04913454|Other|Cognitive training|Cognitive training (1 hour/day, per 5 days/week, for a total of 8 weeks)
15743440|NCT04913441|Other|Routine physical therapy|Patients in this group will get every session routine physical therapy of 30 minutes 3 times per week on alternative days for 12 weeks
15743441|NCT04913441|Other|Manual physical therapy with routine physical therapy|Patients in this group will get every session Manual physical therapy with routine physical therapy of 40 to 45 minutes 3 times per week on alternative days for 12 weeks
15743442|NCT04913441|Other|Stretching physical therapy with routine physical therapy|Patients in this group will get every session of Stretching physical therapy with routine physical therapy of 40 to 45 minutes 3 times per week on alternative days for 12 weeks
15743443|NCT04913428|Other|Interdigital exercise|Patient asked to sit in upright position interlocking their fingers with inhaling deeply bringing the arms up and exhaling through mouth while bring the arm down.
15743444|NCT04913428|Other|Blow-Bottle technique|For blow bottle 20cm of bottle filled with 10cm of water in which a tube of length 35- 40cm inserted with the inner diameter of ≥8mm(21).Patient is asked to form bubbles in bottle by exhaling in bottle performing Forced Expiratory Techniques.
15743445|NCT04913415|Other|Low Suction Strategy of Chest Tube Management|A digital chest tube will be set to a low pressure mode (-8mmHg) during recovery after minimally invasive lung resection.
15743446|NCT04913415|Other|Standard Suction Strategy of Chest Tube Management|A digital chest tube will be to the standard suction mode (-20mmHg) during recovery after minimally invasive lung resection.
15743447|NCT04913402|Other|Sufentanil administered by paramedics after the phone call consultation of medical doctor.|Administration of sufentanil to patients with acute injury by paramedics only after phone-call consultation of medical doctor.
15743448|NCT04913402|Other|Sufentanil administered by paramedics based on their competency, without consultation of medical doctor.|Administration of sufentanil to patients with acute injury by paramedics with competency to administer sufentanil without medical doctor consultation.
15743449|NCT04913389|Drug|Acetazolamide|Acetazolamide (oral capsules @125 mg), starting dose 3 capsules (375 mg), subsequent doses 1 capsule (125 mg) in the morning, 2 capsules (250 mg) in the evening, administered in qualifying participants, during the stay at 3100 m.
15743450|NCT04913389|Drug|Placebo|Placebo (oral capsules, identically looking as active drug), starting dose 3 capsules, subsequent doses 1 capsule in the morning, 2 capsules in the evening, administered in qualifying participants, during the stay at 3100 m.
15743451|NCT04913376|Device|Hilotherapy|Constant cooling device for hands and feet.
15743452|NCT04913363|Other|Green space|Green space in which activities take place
15743453|NCT04913350|Other|Russian current|One of the preferred common neuromuscular electrical stimulation techniques for muscle strengthening is the Russian current (RC) It stimulates almost all muscle motor units to contract synchronously, resulting in a greater muscle hypertrophy.
15743454|NCT04913350|Device|elbow support|tennis elbow brace is recommended to decrease pain and improve function by restricting the movement of the forearm or relieving loads on the origin of the muscles of the extensor
15743455|NCT04913337|Drug|NGM707|"Drug: NGM707
~NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated."
15743456|NCT04913337|Drug|NGM707 plus pembrolizumab|"Drug: NGM707
~NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle. Multiple dose levels will be evaluated.
~Drug: pembrolizumab
~Pembrolizumab will be administered intravenously (IV) every 3 weeks in a 21 day cycle."
15743457|NCT04913337|Drug|NGM707|"Drug: NGM707
~Preliminary recommended phase 2 dose (RP2D) of NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle."
15743458|NCT04913337|Drug|NGM707|"Drug: NGM707
~Preliminary recommended phase 2 dose (RP2D) of NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle."
15743459|NCT04913337|Drug|NGM707|"Drug: NGM707
~Preliminary recommended phase 2 dose (RP2D) of NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle."
15743460|NCT04913337|Drug|NGM707 plus pembrolizumab|"Drug: NGM707
~Preliminary recommended phase 2 dose (RP2D) of NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle.
~Drug: pembrolizumab
~Pembrolizumab will be administered intravenously (IV) every 3 weeks in a 21 day cycle."
15743461|NCT04913337|Drug|NGM707 plus pembrolizumab|"Drug: NGM707
~Preliminary recommended phase 2 dose (RP2D) of NGM707 is given intravenously (IV) every 3 weeks in a 21 day cycle.
~Drug: pembrolizumab
~Pembrolizumab will be administered intravenously (IV) every 3 weeks in a 21 day cycle."
15743462|NCT04913324|Behavioral|Virtual Care|Infants randomized at 4 months of age to the intervention arm will participate in virtual care visits for 16 weeks in addition to standard of care in-hospital visits.
15743463|NCT04913311|Procedure|Biospecimen Collection|Undergo collection of blood, saliva, stool, and bronchoalveolar lavage samples
15743464|NCT04913311|Procedure|Bronchoscopy with Bronchoalveolar Lavage|Undergo bronchoscopy with BAL
15743465|NCT04913311|Other|Chemoradiotherapy|Undergo concurrent chemoradiation per standard of care
15743466|NCT04913311|Procedure|Computed Tomography|Undergo computed tomography scan
15743467|NCT04913311|Other|Diagnostic Laboratory Biomarker Analysis|Correlative studies
15743469|NCT04913311|Procedure|Nasal Wash and Collection|Undergo nasal wash
15743473|NCT04913298|Device|Cytosorb therapy|Start of Cytosorb therapy is at the discretion of the attending physician
15743474|NCT04913285|Drug|KIN-2787|KIN-2787 will be administered orally twice daily in 28-day cycles
15743475|NCT04913272|Drug|US-APR2020|US-APR2020 capsules 45 billion CFUs of the LBT.
15743476|NCT04913272|Drug|Placebo|Placebo
15743477|NCT04913259|Other|Remote monitoring|Online remote monitoring tool during the care of patients over the age of 65 who are receiving medical treatment for cancer
15743478|NCT04913220|Drug|SAR444245|Pharmaceutical Form: Solution for infusion Route of Administration: intravenous infusion
15743479|NCT04913220|Drug|Cemiplimab|Pharmaceutical Form: Solution for infusion Route of Administration: intravenous infusion
15743480|NCT04913207|Procedure|method of device size selection|device size selection based on 3D-CTA
15743481|NCT04913194|Behavioral|ARFID-PTP|ARFID-PTP is a two-session virtual protocol using psychoeducation, parent training skills, and exposure to decrease picky eating symptoms consistent with an ARFID diagnosis.
15743482|NCT04913181|Diagnostic Test|Artificial intelligence sepsis prediction model|The main purpose of this paper is to evaluate the accuracy of the sepsis prediction model established in the early stage. The occurrence of sepsis is determined by the daily clinical judgment of doctors, and the results of sepsis prediction model are matched and corrected.
15743483|NCT04913168|Other|Front Line Worker Pilot Project|13-month intervention targeting workplace policies and programs focused on changes to safety and ergonomics, job enrichment, and work intensity for front line food service workers practices,
15743484|NCT04913155|Radiation|Low-dose CT screening|Low-dose computed tomography with lung nodule evaluation (LungRADS1.1, highrisk score group), randomized reporting of coronary artery calcium score and emphysema score
15743485|NCT04913142|Other|Fecal and oral samples|oral and rectal swab from patients hospitalized at day 1, each 7 days and at the end of their ICU stay
15743486|NCT04913129|Other|Exercise Training|8 week home-based exercise therapy 4-5 times/week
15743487|NCT04913116|Diagnostic Test|Comparison of antigen tests with RT-PCR as reference method|Antigen tests are performed locally including sampling from multiple anatomical testing sites. A reference oropharyngeal swab is always send for RT-PCR for SARS-CoV-2 at DTU to verify the status of the patient. RT-PCR samples from other anatomical test locations may be included.
15743488|NCT04913103|Drug|Polatuzumab vedotin|treatment by a study drug polatuzumab-vedotin, i.v.
15743489|NCT04913103|Drug|Bendamustine Hydrochloride|treatment by a study drug bendamustin i.v.
15743490|NCT04913103|Drug|Rituximab|treatment by a study drug rituximab, i.v.
15743491|NCT04913090|Drug|XZP-5610 Tablet (for Part A)|Tablet(s) administered orally once daily for 1 Day
15743492|NCT04913090|Drug|Placebo to match XZP-5610 Tablet (for Part A)|Tablet(s) administered orally once daily for 1 Day
15743493|NCT04913090|Drug|XZP-5610 Tablet (for Part B)|Tablet(s) administered orally once daily for 14 Days
15743494|NCT04913090|Drug|Placebo to match XZP-5610 Tablet (for Part B)|Tablet(s) administered orally once daily for 14 Days
15743495|NCT04913090|Drug|"XZP-5610 Tablet （for Part C1）"|Tablet(s) administered fasted orally once daily for 1 Day
15743496|NCT04913090|Drug|"XZP-5610 Tablet for Part C2"|Tablet(s) administered after a high-fat meal orally once daily for 1 Day
15743497|NCT04913077|Other|removal of submucosal gastric tumor preferably by Full Thickness Resection Device (FTRD)|FTRD (Ovesco company) in tumors up to 10 mm and predominantly intraluminal growth directly by sucking into the cap, at 10-20 mm and/or intramural/extramural growth by prior circumcision and lateral preparation, so that the lesions can be better pulled into the cap. The procedure depends on the endosonographic extent of the findings. The lesions are pulled into the cap with grippers and other instruments and, if necessary, with a snare and then resected with FTRD
15743498|NCT04913064|Other|Questionnaire Administration|Ancillary studies
15743499|NCT04913064|Drug|White Button Mushroom Extract|Given PO
15743500|NCT04913025|Drug|Nivolumab|60-minute IV infusion, as a flat dose of 480mg
15743501|NCT04913025|Drug|Pembrolizumab|60-minute IV infusion, as a flat dose of 400mg
15743502|NCT04913012|Combination Product|Systematic aerobic training|Two-three weekly supervised aerobic exercise sessions for 12 weeks. The training will be planned by exercise physiologists, and performed in a progressive manner.
15743503|NCT04913012|Combination Product|Systematic resistance training|Two-three weekly supervised resistance exercise sessions for 12 weeks. The training will be planned by exercise physiologists, and performed in a progressive manner.
15743504|NCT04913012|Combination Product|Aerobic training booster sessions|Supervised aerobic training booster sessions delivered in the follow up period (two sessions every fifth week).
15743505|NCT04913012|Combination Product|Resistance training booster sessions|Supervised resistance training booster sessions in the follow up period (two sessions every fifth week).
15743506|NCT04912986|Behavioral|Early Lung Rehabilitation Training|It is implemented in accordance with the Early Lung Rehabilitation Training Program for Adult Double Lung Transplant Patients. Establish multidisciplinary collaboration teams, including competent doctors, nurses, rehabilitation physicians, and psychologists.
15743507|NCT04912986|Behavioral|Routine treatment|Provide rehabilitation training as usual, without standard program
15743508|NCT04912973|Procedure|Robotically Assisted Total Knee Arthroplasty - Knee Replacement|Robotically Assisted Total Knee Arthroplasty with a particular alignment strategy
15743509|NCT04912960|Device|Mechanical ventilation|Optimum PEEP
15743510|NCT04912947|Dietary Supplement|Immusystem|Dietary supplement containing: Piceid, Glycine, Glutamine, Acetylcysteine, Zinc and Vitamin B6
15743511|NCT04912947|Other|Placebo|Maltodextrin placebo capsule
15743512|NCT04912934|Procedure|A survey form was applied to individuals included in the study face-to-face.|This study was completed with a descriptive, cross-sectional and relational screening model
15743513|NCT04912921|Dietary Supplement|palmitoylethanolamide|4 tablets taken daily (2 in the am and 2 in the pm)
15743514|NCT04912921|Dietary Supplement|Placebo|4 tablets taken daily (2 in am and 2 in pm)
15743515|NCT04912908|Other|Images taken during knee replacement surgery|Images taken during knee replacement surgery will be compared to CT-Scan that was performed before surgery
15743516|NCT04912895|Device|PneumoniaCheck|Participants are asked to do 5 sets of 10 coughs into the PneumoniaCheck device.
15774934|NCT04655391|Drug|Enasidenib Mesylate|Given IV
15743517|NCT04912882|Diagnostic Test|Circulating tumor cell|detecting circulating tumor cell pre- and post operatively
15743518|NCT04912869|Drug|Crovalimab|Crovalimab will be administered as a single dose of 1000 mg IV (for participants with a body weight between 40 kg and 100 kg) or 1500 mg IV (for participants with a body weight >=100 kg).
15743519|NCT04912869|Drug|Placebo|Placebo will be administered as a single IV infusion, with an equal volume and over the same duration as weight- based crovalimab
15743522|NCT04912843|Drug|NR082 injection|Intravitreal injection（IVT）
15743524|NCT04912817|Other|Off the Shelf VR|"Operates using Oculus quest VR HMD and uses auditory and visual stimuli during the pain rehabilitation treatment. The Off-the-shelf VR program for Oculus Quest VR features a suite of off-the shelf applications that can be tailored by the PT and used with participants including. PR-VR sessions will be 30 minutes in total with approximately 20 minutes in the virtual experience and 10 minutes for set-up, screening, instructions, and rest breaks. The Off-the-shelf VR intervention group will also receive 30 minutes of usual care, and Standard Virtual Physiotherapy Treatment (SVPT) during the same appointment, for a total 1-hour usual care session length."
15743525|NCT04912817|Other|Custom VR|Operates using Oculus Quest VR HMD with PR-VR software developed with two gaming options: Fruity Feet and Space Burgers 2. Game settings are manipulated by the physiotherapist in session to target specific limb movements and intensity and also motivates participants to cycle using a leg ergometer. Motion sensors on the ergometer track the participants revolutions per minute. For participants in this study arm, a leg ergometer (DeskCycle) will be provided to them during the study phase alongside the Actigraph and Oculus Quest HMD. During the 30min VR portion of the session, 20 minutes will be dedicated to gaming and exercise, and 10 minutes dedicated for set up, tear down, and rest breaks. During the 20 minutes gaming time, a minimum of 15 minutes will be dedicated to Custom VR, with 5 minutes for 'free play' where the participant can opt to try an off-the-shelf VR game.
15743526|NCT04912804|Other|Questionnaires|SF-12, GHQ-12 and HAQ
15743528|NCT04912778|Other|Filling in an online survey|Patients are asked to fill in an online survey regarding functional status, quality of life and symptoms of central sensitisation.
15743529|NCT04912765|Biological|Neoantigen Dendritic Cell Vaccine|10 doses of the vaccine will be administered via intra-dermal injection concurrently with adjuvant nivolumab.
15743530|NCT04912765|Drug|Nivolumab|9 doses of 240mg IV nivolumab as a 30 minutes infusion will be administered in combination with NA DC vaccine starting from the second vaccine dose. Upon completion of 10 doses of NA DC vaccine, 480mg IV nivolumab will be administered as a 30 minutes infusion for a maximum of 9 doses.
15743531|NCT04912752|Genetic|Migraine CNV|Copy number variation effect on migraine disease
15743532|NCT04912739|Behavioral|Targeted health dialogues|"Before the targeted health dialogue, the participants fill in a questionnaire about health behaviors, background characteristics and self-rated health. Samples for blood glucose and total cholesterol are taken. BMI, waist-to-hip ratio and blood pressure are measured. The results are summoned in a health curve, which is discussed with specially trained healthcare personnel in a Targeted heath dialogue. In a sub-group, blood samples are collected for molecular analyses."
15743533|NCT04912726|Drug|Sildenafil Injectable Product|The intervention group will receive intravenous sildenafil loading dose of 0.4 mg / kg in 3 hours and continue in continuous infusion at 1.6 mg / kg / day (0.067 mg / kg / h).
15743534|NCT04912713|Other|Stress group|This group will perform the MAST stress protocol
15743535|NCT04912713|Other|Control group|This group will perform the MAST control protocol
15743536|NCT04912700|Biological|COVID-19 vaccine|Full or partial reception of vaccine
15743537|NCT04912687|Diagnostic Test|EGFR gene mutation analysis on liquid biopsy|Blood samples will be collected at inclusion for plasma DNA collection and analysis.
15743539|NCT04912661|Dietary Supplement|Ferinject|intravenous iron carboxymaltose
15743540|NCT04912648|Other|Longitudinal follow up|Repeat follow up at 3,5 and 10 years
15743541|NCT04912635|Other|Neo App|Neo is a smartphone-based dashboard application that utilizes concepts from behavioral science and health psychology to support patients to improve their adherence to therapy. This is done through behavior change techniques and intervention functions (Michie, Atkins & West, 2014). This app is designed to prompt participants' self-regulation of lifestyle and health behaviors, to support adherence to therapy. Such self-regulation of lifestyle behaviors is informed by presenting health metric data (through wearables, myAir (biofeedback) and self-report), in an easy to understand dashboard platform on the app. Participants will be asked to use their PAP device (as normal), use a Withings blood pressure cuff and activity monitor. This data is brought into the Neo app through an API Exchange gateway. This data will be presented to the participant and communicated in an easy to understand way.
15743542|NCT04912622|Diagnostic Test|Clinical Trial|Retinal image acquisition with Cellularis version 2.0
15743543|NCT04912596|Drug|Albuterol Sulfate inhalation aerosol 108 mcg per actuation|eq. to albuterol 90 mcg/puff, MDI
15743544|NCT04912596|Drug|Proair HFA (Albuterol Sulfate) Inhalation Aerosol 90 mcg per actuation|eq. to albuterol 90 mcg/puff, MDI
15743545|NCT04912596|Other|Proair HFA Inhalation Placebo|MDI
15743546|NCT04912596|Other|Albuterol Sulfate inhalation Placebo|MDI
15743547|NCT04912596|Other|Methacholine|Methacholine 100 mg/vial
15743548|NCT04912583|Device|High tidal volume|A high tidal volume (14-16 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation.
15743549|NCT04912583|Device|Low tidal volume|A low tidal volume (8-10 ml/kg pbw) with positive end-expiratory pressure will be applied during mechanical ventilation.
15743550|NCT04912570|Procedure|Manual Thrombus Aspiration|Manual thrombus aspiration using one of the FDA approved aspirators will be done.
15743552|NCT04912557|Other|postoperative pain assess|numerical pain scale and Metameric levels of cold insensitivity
15743553|NCT04912544|Device|Noninvasive Ventilation Mask Microphone|Noninvasive Ventilation Mask Microphone is turned on to enhance speech intelligibility during the intervention portion of the crossover feasibility study
15743554|NCT04912531|Device|Virtual Realty using a Microsoft Hololens, Empatica HR wristband, and EEG|The investigators will use a DeepReality VR with biofeedback using a Microsoft Hololens, Empatica HR wristband and EEG. The Empatica HR wristband will measure HR and the EEG will measure alpha and theta brain waves. To monitor the physiologic data in real-time, data from the EEG and heart rate monitor will be streamed and processed in an Android Application that the investigators previously developed. During data collection, the Android app sends data via OSC to a specific IP and port, which is then collected in the game engine, Unity 3D and processed to adapt the virtual environment. Importantly, each device is inexpensive and can be sanitized and reused by multiple patients.
15743555|NCT04912531|Device|Essence Olfactory Necklace|The Essence Olfactory Necklace holds a small, lightweight 7 ml capsule that contains an essential oil. Within the capsule is a piezo electric transducer which allows us to control the release of scent via Bluetooth using a smartphone app. Each Essence Necklace will be paired with a google phone that the investigators will use to control the frequency and intensity of scent for each patient. The investigators will limit the frequency to one burst of scent every 20 seconds to avoid habituation. For the scent, the investigators will use diluted lavender essential oil (10% essential oil: 90% water). The investigators chose lavender because in our previous studies, >97% of users enjoyed the lavender scent. The Essence Necklace is powered with a 3.7V Lithium Battery and has a battery lifetime of approximately 6 hours. The RC can easily recharge the Essence Necklace through a USB micro connector. Additionally, the Essence Necklace can be easily sanitized and reused by multiple patients.
15743556|NCT04912531|Device|Bedside Olfaction Device|The bedside olfaction device can be clipped on to the side of the patient's bed or beside table. The RC will turn on the night-time olfactory device at 7 pm and will turn off the device at 7 am. When turned on, the device releases scent once every 60 seconds. However, the frequency and intensity of the scent will be adjusted to the patient's preferences. For the scent, the investigators will use diluted lavender essential oil (10% essential oil: 90% water).
15743557|NCT04912518|Drug|Dexmedetomidine (DEX)|The patient began to inject DEX intravenously as soon as he enrolled. This study started with the maximum maintenance dose allowed by the label (0.7μg/kg/h). With reference to previous studies, we set 3 pump injection gradients within the range of 0.2-0.7μg/kg/h (0.2μg/kg/h, 0.45μg/kg/h, 0.7μg/kg/h), and based on the patient's heart rate , systolic blood pressure and RASS sedation score to adjust.
15743558|NCT04912518|Drug|Placebo (Saline)|The patient began intravenous injection of normal saline immediately after enrollment. The administration method and dosage adjustment of normal saline are the same as DEX.
15743560|NCT04912492|Behavioral|RealConsent1.0|A web-based multi-media sexual violence prevention program that enhances knowledge and skills for effective consent for sex and for prosocial bystander behaviors.
15743561|NCT04912492|Behavioral|RealConsent2.0|A revised and updated web-based multi-media sexual violence prevention program that enhances knowledge and skills for effective consent for sex and for prosocial bystander behaviors, but also integrates new program segments into RealConsent 1.0 specific to how alcohol use can inhibit SV intervention at multiple steps of the decision-making process.
15743562|NCT04912492|Behavioral|Stress Management|A web-based multimedia program designed to help individuals recognize the symptoms and sources of stress and provide them with a wide variety of powerful tools for managing stress.
15743563|NCT04912492|Behavioral|Alcohol intoxication|Men assigned to moderate alcohol dose condition (target BrAC .08%) with NIAAA approved alcohol administration procedures
15743564|NCT04912492|Behavioral|No-Alcohol Placebo|Men assigned to an no-alcohol placebo control condition.
15743566|NCT04912466|Drug|Biological: IBI322|Recombinant anti-human CD47/PD-L1 bispecific antibody injection
15743567|NCT04912453|Procedure|Primary anastomosis|At laparotomy, the diseased segment of intestine will be resected and the patients will then receive primary anastomosis
15743568|NCT04912453|Procedure|Enterostomy|At laparotomy, the diseased segment of intestine will be resected and the patients will then receive enterostomy
15743569|NCT04912440|Device|MSE-ERCP|No interventional study, MSE-ERCP performed within routine treatment, (approved indication of device)
15743570|NCT04912427|Drug|Isatuximab|Isatuximab is supplied by Sanofi.
15743571|NCT04912427|Drug|Bortezomib|Bortezomib is commercially available.
15743572|NCT04912427|Drug|Dexamethasone|Dexamethasone is commercially available.
15743573|NCT04912414|Behavioral|Brief Family Therapy (BFT)|Patients transferred to the hospital for the treatment of psychosomatic symptoms was randomized (1:1) to receive either Brief Family Therapy (BFT) or a control treatment. Some participants randomized to the BFT arm receive a combination of chemotherapy and BFT and others receive only BFT. BFT comprises 10 sessions using a generic model of problem formation and resolution. This psychotherapy is useful for treating individual, couple, and family problems. Its broad applicability is based on its view that the client's complaint is the problem, not a symptom of something else BFT views behavior, especially a client's problematic behavior, as a function of interaction with other people. After randomization, all participants were asked to complete questionnaires about their psychosomatic symptoms and health at baseline, at the end of the intervention (at 4 months).
15743574|NCT04912388|Other|Lumbal stabilization excercises|The stabilization group will perform lumbal stabilization exercises in lying, sitting, standing and on a swisball 3 times a week during 6 weeks.
15743575|NCT04912388|Other|Conventional exercises|The general exercise group will perform conventional exercises 3 times a week during 6 weeks.
15743576|NCT04912375|Behavioral|Priming intervention|The pilot RCT will ask participants to complete a simple word-searching exercise as a goal-priming of healthy eating and can be completed in 5 min.
15743577|NCT04912362|Device|YAG iridotomy|YAG iridotomy was performed one week before operation, and then CO2 Laser-Assisted Sclerectomy Surgery was performed
15743578|NCT04912349|Procedure|TUSP|Patients received the transurethral split of the prostate(TUSP) treatment.
15743579|NCT04912349|Procedure|TURP|Patients received the transurethral resection of the prostate(TURP) treatment.
15743580|NCT04912336|Diagnostic Test|Standard coagulation profile|prothrombin time (PT), international normalized ratio (INR), activated partial thromboplastin time (aPTT), the fibrinogen level, plateletcount
15743581|NCT04912336|Diagnostic Test|Specific coagulation tests|AT III, anti Xa, ACT, ROTEM
15743582|NCT04912336|Other|Bleeding Scores|Global Utilization of Streptokinase and Tpa for Occluded arteries definition of bleeding (GUSTO) AND Bleeding Academic Research Consortium Definition for Bleeding (BARC)
15743583|NCT04912323|Device|Percutaneous Implantation of the MAGNITUDE® Bioresorbable Arterial Scaffold|Placement of one or more MAGNITUDE® bioresorbable scaffolds using a percutaneous technique at one or more arterial stenoses.
15743584|NCT04912310|Device|Argon laser peripheral iridoplasty|Argon laser peripheral iridoplasty was performed in patients with severe acute angle closure glaucoma whose intraocular pressure could not be controlled by medication
15743585|NCT04912297|Biological|10-valent pneumococcal conjugate vaccine, PCV10|10-valent pneumococcal conjugate vaccine, PCV10
15743586|NCT04912271|Drug|Granisetron transdermal patch|Granisetron transdermal delivery system (GTDS) is the first 5-HT3 drug to be transdermally delivered and represents a convenient alternative to oral and intravenous antiemetics for the treatment of chemotherapy-induced nausea and vomiting.
15743587|NCT04912271|Drug|Palonosetron|Palonosetron is a second-generation 5-HT3 receptor antagonist with proposed higher efficacy and sustained action for prophylaxis of postoperative nausea and vomiting (PONV).
15743588|NCT04912271|Drug|Aprepitant|Aprepitant is a licensed treatment for nausea and vomiting, which blocks substance P activation of NK-1 (neurokinin 1) receptors.
15743589|NCT04912271|Drug|Fosaprepitant|Fosaprepitant is a neurokinin-1 receptor antagonist, approved for the prevention of chemotherapy-induced nausea and vomiting.
15743590|NCT04912271|Drug|Dexamethasone|Dexamethasone, one of the glucocorticoids, has been suggested as a first-line drug for preventing low-level emetogenic chemotherapy- and radiotherapy-induced nausea and vomiting.
15743591|NCT04912258|Drug|Trans arterial chemoembolization with Irinotecan Drug-eluting Beads|preoperative chemoembolization with Irinotecan Drug-eluting Beads
15743592|NCT04912245|Behavioral|Telehealth visit|Patients with either MCI or unrecognized dementia and their care partners (if available) will be approached to participate in a telehealth Advance Care Planning (ACP) visit with a member of the patient's primary care team via either telephone or video. Patients without willing or available care partners are still eligible to participate in the study.
15743593|NCT04912232|Device|Detection of Occult Hemorrhage in Trauma Patients|Non-invasive monitoring of trauma patients
15743594|NCT04912219|Device|Microneedling|"Skin will be pretreated with topical 15% lidocaine creaml for 20 minutes. Water-soaked gauze will then be used to remove the lidocaine gel. Treated skin will be cleaned with 70% ethyl alcohol, allowed to dry, and then treated with hyaluronic acid gel.
~Manual traction will be applied to the skin of the treatment arm, and the SkinPen microneedle device with 0.5mm microneedles attached will be passed over the forearm skin in a cross-hatch pattern until an endpoint of fine pinpoint bleeding is achieved.
~Manual pressure with sterile ice water compresses will be used until hemostasis is achieved.
~This will be repeated for a total of four treatments one month apart"
15743595|NCT04912206|Diagnostic Test|Point-of-Care Ultrasound|Abdominal clinician-performed Ultrasound
15743596|NCT04912193|Drug|Antithrombin III|In liver transplant recipients with baseline antithrombin III levels lower than 50%, exogenous Antithrombin III was administrated during the anhepatic phase of the liver transplant surgery.
15743597|NCT04912167|Drug|Sacubitril-Valsartan|After initiation of the treatment of sacubitril/valsartan, the dose of the medicine will be titrated to a target level based on the systolic blood pressure of the patients. (24/26 mg, 49/51 mg and 97/103 mg, twice daily)
15743598|NCT04912167|Drug|Enalapril|After initiation of the treatment of enalapril, the dose of the medicine will be titrated to a target level based on the systolic blood pressure of the patients. (2.5 mg, 5 mg, and 10 mg,twice daily)
15743599|NCT04912167|Drug|Valsartan|For patients who were previously treated with ACEI and receiving the last dose of that agent during the last 36 hours prior to randomization, Valsartan (VAL489) 40 mg and 80 mg tablets, two doses for 1 day was used.
15743600|NCT04912154|Procedure|Rehabilitation protocol|Rehabilitation protocol after open surgery for Achilles tendon rupture
15743601|NCT04912141|Drug|conestat alfa or placebo|"Conestat alfa will be dosed by body weight at 50 U/kg (maximum 4200 U) or 100 U/kg (maximum 8400 U).
~Placebo will consist of normal saline (NaCl 0.9%). The interventions will be given to the patients by IV-line."
15743602|NCT04912128|Drug|Anlotinib|"Anlotinib is a novel multi-target tyrosine Kinase inhibitor that inhibits VEGFR2/3, FGFR1-4, PDGFD α/β, c-Kit and Ret.
~Stereotactic Radiosurgery Stereotactic Radiosurgery as the initial treatment of non small cell lung cancer patients with limited brain metastases"
15743605|NCT04912102|Device|high flow nasal oxygen device (HFNO)|it is a novel technique by which heated humidified oxygen is supplied via nasal prongs at flow rates ranging from 40 to 70 L/minute. The Fio2 ranges from 0.21 to 1.0.
15743606|NCT04912089|Behavioral|COGENT|COGENT is based on a working memory capacity task, which requires individuals to memorize stimuli while simultaneously completing a secondary puzzle task.
15743607|NCT04912076|Drug|BM41|Subcutaneous injection of increasing doses of BM41
15743608|NCT04912076|Other|Placebo|Subcutaneous injections of placebo containing aluminium hydroxide.
15743609|NCT04912076|Drug|ALK Alutard SQ Betula verrucosa|Subcutaneous injections with increasing doses of Alutard according to cluster up-dosing scheme.
15743610|NCT04912063|Drug|Lemzoparlimab|Intravenous (IV) Infusion
15743611|NCT04912063|Drug|Azacitidine|Subcutaneous Injection or Intravenous (IV) Injection/Infusion
15743612|NCT04912063|Drug|Venetoclax|Oral Tablet
15743613|NCT04912050|Device|Tablo Hemodialysis System|Renal Replacement Therapy between 12< to ≤ 24 hours.
15743614|NCT04912037|Device|artificial intelligence assistance system|the artificial intelligence assistance system can indicate abnormal lesions and real-time withdrawal speed, and feedback the overspeed percentage.
15743615|NCT04912024|Device|Intermittent Renal Replacement Therapy using the Tablo Hemodialysis System|Intermittent renal replacement therapy using the Tablo Hemodialysis System in the acute setting for participants with AKI or ESKD
15743616|NCT04912024|Device|Intermittent Renal Replacement Therapy using Conventional Hemodialysis Systems|Intermittent renal replacement therapy using Conventional Hemodialysis Systems in the acute setting for participants with AKI or ESKD
15743617|NCT04912011|Drug|Canrenoate Potassium|Intervention: 200 mg of Canrenoate potassium in 100 ml 0,9% NaCl, intravenously twice a day for 7 days.
15743618|NCT04912011|Drug|Normal Saline|Placebo: 100 ml 0,9% NaCl, intravenously twice a day for 7 days.
15743619|NCT04911985|Device|Measurement of the Cardiac Output/ Cardiac Index|Semiinvasive Measurement of the Cardiac Output/ Cardiac Index with the Pulsion device
15743620|NCT04911972|Procedure|Functional muscle transfer|Muscle transfer to restore lower limb function
15743621|NCT04911959|Drug|Lenvatinib|Lenvatinib is taken orally
15743622|NCT04911959|Procedure|TACE|TACE treatment once
15743623|NCT04911946|Other|Questionnaire|After signing the informed consent form agreeing to participate in the study, the participants answered the questionnaire about diagnostic and therapeutic questions related to a clinical case of osteoporotic fracture in 4 scenarios: the initial care in the emergency room, at the time of discharge from hospital, during their outpatient return in 3 and 6 months.
15743624|NCT04911933|Behavioral|Family Therapy|There will be systemic family psychotherapy sessions every two weeks. Families and individuals who require a more intensive service will be referred to a higher level of care.
15743625|NCT04911920|Other|Questionnaire Patient Rated Tennis Elbow Evaluation|Participants are asked to complete questionnaires at three measurement time points.
15743626|NCT04911907|Drug|utidelone injection|Utidelone monotherapy 35 mg/m2/day IV transfusing over 90 min. on day 1-day 5 of each 21 day cycle
15743627|NCT04911894|Drug|IBI321|Several dose levels will be evaluated for IBI321 administered as a single agent. IBI321 will be given via IV infusion on Day 1 of each cycle until disease progression or loss of clinical benefit.
15743628|NCT04911881|Drug|IBI321|Several dose levels will be evaluated for IBI321 administered as a single agent. IBI321 will be given via IV infusion on Day 1 of each cycle until disease progression or loss of clinical benefit.
15743629|NCT04911842|Device|HydroMID|Hydrophilic biomaterial
15743630|NCT04911842|Device|TPU|Thermoplastic polyurethane
15743631|NCT04911829|Behavioral|Psychotherapy|
15743632|NCT04911816|Drug|Hydroxychloroquine sulfate|Hydroxychloroquine, oral, dose escalated (400mg, 800mg, 1200mg) beginning concurrent with mFOLFIRINOX and extending 2 weeks post-operatively. Dose will be assigned to patients using 3+3 Algorithm to identify the Maximum Dose Tolerated.
15743633|NCT04911803|Behavioral|Anxiety Application|The Intellect mobile app (containing the anxiety application) can be freely downloaded from the App store and Google Play store for free. The app provides access to the different programmes. The mobile app has been pilot tested by Intellect before the release on the App and Google Play store. However, for this research project Intellect is going to provide the the programmes as stand alone applications exclusively for the participants of this research.
15743634|NCT04911803|Behavioral|Procrastination Application|The Intellect mobile app (containing the procrastination application) can be freely downloaded from the App store and Google Play store for free. The app provides access to the different programmes. The mobile app has been pilot tested by Intellect before the release on the App and Google Play store. However, for this research project Intellect is going to provide the the programmes as stand alone applications exclusively for the participants of this research.
15743636|NCT04911777|Drug|Pentarlandir™ UPPTA|Pentarlandir™ UPPTA is a white oral capsule (with 188 mg of UPPTA)
15743637|NCT04911777|Drug|Placebo|The placebo of Pentarlandir™ UPPTA is a white oral capsule (without UPPTA)
15743638|NCT04911764|Diagnostic Test|Three-min Step Test and Exercise desaturation detection in COPD|For this research, 2 visits will be scheduled (V1 and V2) for each patient. During V1, after collecting the filled and signed consent form from the patient, anthropometric measurements and pulmonary function assessment will be performed before the realization of a maximal graded test. This inclusion visit will be carried out as part of an inclusion within a respiratory rehabilitation program. During V2, each patient will randomly perform a 6-minute walking test and a 3-minute step test, in similar standard conditions. A 30-minute resting period will be allowed between the two field tests. During the realization of the tests, cardio-respiratory adaptations will be monitored throughout both tests with portable gas analyzer and pulsed oxymetry system.
15743639|NCT04911751|Drug|KBL697|1 capsule BID of KBL697 or Placebo
15743640|NCT04911751|Drug|KBL697|5 capsules BID of KBL697 or Placebo
15743641|NCT04911738|Other|Virtual Reality , immersion in a virtual titlted room|The immersion in virtual reality will be based on the HTC VIVE® device and the software developed by the Virtualis Society.
15743642|NCT04911725|Device|Elastic Compression Prototype|Elastic Compression device - No medical, surgical or laboratory procedure is implied in the use of the IMD.
15743643|NCT04911712|Dietary Supplement|a hospital formula of normal protein liquid diet supplementation|group 1 (control group) who will get a hospital formula of normal protein liquid diet supplementation (40 grams per 1000 mL)
15743644|NCT04911712|Dietary Supplement|a hospital formula of high protein liquid food supplementation|group 2 (intervention group) will get a hospital formula of high protein liquid food supplementation (60 grams per 1000 mL) as much as 2 bottles (each bottle contains 200 mL)
15743645|NCT04911699|Behavioral|breast adenocarcinoma receiving chemotherapy|for chemotherapy
15743646|NCT04911699|Behavioral|Control-for|hormonal drug treatment
15743647|NCT04911686|Device|rod distraction|Our study entails the application of a simple method for correction of FKFD in younger children using a simple cast distraction technique. This conservative method aims at avoiding the complications of surgery in children while achieving a reasonable amount of correction.
15743676|NCT04911439|Other|High arousal|This group will see affective images of the International Affective Picture System with high arousal level
15743648|NCT04911673|Behavioral|music|Participants listened a song with headphones that lasts 29 minutes and 32 seconds for four days (three days before menstruation and the first day of menstruation).
15743649|NCT04911673|Dietary Supplement|Chocolate group|Participants ate 40 mg of dark chocolate with 60% cocoa per a day for four days (three days before menstruation and the first day of menstruation) that was given by researchers to them.
15743652|NCT04911647|Device|ERCP using plastic stent|Insertion of plastic stent (plastic stent with inner diameter 1.8mm or more) in the biliary obstruction will be performed using ERCP in the patients with the pancreatic cancer undergoing neoadjuvant therapy.
15743653|NCT04911647|Device|ERCP using metal stent|Insertion of metal stent (full covered self-expandable metal stent) in the biliary obstruction will be performed using ERCP in the patients with the pancreatic cancer undergoing neoadjuvant therapy.
15743654|NCT04911621|Biological|Dendritic cell vaccination + temozolomide-based chemoradiation|"Leukocyte apheresis (before chemoradiation): for dendritic cell (DC) vaccine production.
~Chemoradiation (1st part standard treatment, initiated as soon as the patient's hematological blood values are adequate after apheresis, but no later than 6 weeks after surgery or confirmed diagnosis): 1.8 Gy once daily 5 days/week for 6 weeks with 90 mg/m² temozolomide daily from the first until the last day of radiotherapy.
~Induction immunotherapy: intradermal vaccination with autologous Wilms' tumor-1 (WT1) mRNA-loaded DCs weekly (-1 day, +2 days) for 3 weeks, starting ≥ 1 week after radiotherapy.
~Chemo-immunotherapy: 150-200 mg/m²/d temozolomide days 1-5 every 28 days +/- 3 days (max. 6 months, 2nd part standart treatment) starting ≥3 days after the third vaccine of the induction immunotherapy + DC vaccination on day 21±3 days of every 28-day cycle."
15743655|NCT04911621|Biological|Dendritic cell vaccination +- conventional next-line treatment|"Leukocyte apheresis (upon recovery of hematological blood values following previous anti-glioma treatments and ≥ 4 weeks after the last dose of any investigational agent): for DC vaccine production.
~Induction immunotherapy: intradermal vaccination with autologous WT1 mRNA-loaded DCs weekly (-1 day, +2 days) for 3 weeks, starting ≥ 4 weeks after apheresis.
~Booster immunotherapy: 6 DC booster vaccinations administered at regular intervals (+- 4 weeks), starting ≥ 3 weeks after the last induction vaccine.
~(Optional) Concomitant conventional anti-glioma treatment: The decision to continue or re-initiate conventional anti-glioma treatment, and, if applicable, its dose and scheme, are at the Investigator's discretion and will depend on the patient's previous treatment scheme and condition."
15743656|NCT04911608|Other|cervical spinal manipulation|High-velocity, mid-range, low amplitude force at the segment of pain and/or segmental restriction. The participant will lay comfortably in a supine position, the practitioner will then use his clinical discretion to select the most appropriate or symptomatic cervical motion segments and attempt to localize the manual thrust at those levels. A maximum of 2 attempts for each side of the cervical spine will be allowed regardless of the having achieved joint cavitation.
15743657|NCT04911608|Other|cervical spinal mobilization|Participant will lay comfortably in a prone position, the practitioner will then use his clinical discretion to select the most appropriate or symptomatic cervical motion segments and attempt to localize the manual forces at those segments.
15743658|NCT04911595|Diagnostic Test|exercise oximetry|transcutaneous oxygen pressure is measured at the skin level on chest , buttocks and calves during a walking test 3.2 km*:h 10% slope. From the test result the decrease from rest of oxygen pressure (DROP) index is calculated to estimate muscle ischemia
15743659|NCT04911595|Diagnostic Test|thallium scintigraphy|Muscle thallium fixation is measured immediately after a walking test 3.2 km*:h 10% slope and at 4 hours after the test. From the test result the difference of late and early radioactivity is calculated at the buttock and calf level and normalized to total body radioactivity to estimate muscle ischemia
15743660|NCT04911582|Dietary Supplement|Cafestol 12 mg|Capsule with 12 mg cafestol
15743661|NCT04911582|Dietary Supplement|Placebo|Placebo capsule without cafestol
15743662|NCT04911582|Dietary Supplement|Cafestol 6 mg|Capsule with 6 mg cafestol
15743663|NCT04911569|Device|Cryoneurolysis|Cryoneurolysis
15743664|NCT04911556|Dietary Supplement|Bifidobacterium longum|types of intestinal flora
15743665|NCT04911556|Dietary Supplement|A placebo made of starch|placebo
15743667|NCT04911530|Other|no intervention|no intervention
15743669|NCT04911491|Device|IMST|Inspiratory muscle strength training (IMST) is a form of physical training that utilizes the diaphragm and accessory respiratory muscles to repeatedly inhale against resistance using a handheld device.
15743670|NCT04911491|Device|Sham Training|Repeated inhalations against a low resistance will be performed using a handheld device.
15743671|NCT04911478|Genetic|ADI-001|No study drug is administered in this study. Patients who have received ADI-001 allogeneic T cell therapy will be evaluated in this trial for long-term safety and efficacy
15743672|NCT04911465|Device|Flashback CRI T1 Tablet|Collect continuous data on the compensatory reserve index, a measurement of a patient's central volume status.
15743673|NCT04911452|Device|Calmer|Once randomized, infants in the Calmer group will receive treatment for a minimum cumulative total of 3 hours/day during periods when the infant may be too ill to be held or when parents do not wish to hold their infant or are not present. Calmer does not replicate a parent's contact and so the minimum exposure has been tripled. No upper limit of Calmer use will be set. Each day, the research and/or bedside nurse will record the heart and respiratory rates for a two-minute period. The one-minute average will be used to program Calmer for each infant that day to better simulate day-to-day changes in infant-parent contact. The Neonatal Intensive Care Unit (NICU) research nurse will also train the parents/caregivers to self-measure their resting heart and breathing rates so that if they are away from the NICU for more than one day, these values can be sent to the research/ bedside nurse by phone.
15743674|NCT04911439|Other|Low Arousal|This group will see affective images of the International Affective Picture System with low arousal level
15743675|NCT04911439|Other|Medium arousal|This group will see affective images of the International Affective Picture System with medium arousal level
15743677|NCT04911426|Behavioral|Telehealth|The telehealth intervention is delivered with an app developed for this research. The intervention features live video calling, messaging, appointment reminders; clinical support is provided by licensed clinicians.
15743678|NCT04911413|Drug|Tranexamic acid|The drug used in this RCT is tranexamic acid. We used three different doses of TXA in three groups.
15743679|NCT04911400|Other|Upper-lower clear plastic retainers + Class III elastics|Addition of Class III elastics to clear plastic retainers
15743680|NCT04911400|Other|Upper-lower clear plastic retainers|Upper-lower clear plastic retainers
15743681|NCT04911387|Device|Intraocular pressure measurments|Intraocular pressure measurements with iCare Home by participants (patients, volunteers) and healthcare staff as well as intraocular pressure measurements with GAT by participants different healthcare staff.
15743682|NCT04911374|Other|Gentle Cleansing Lotion, Revision Skincare|Gentle cleansing lotion to be used by study participants
15743683|NCT04911374|Other|Aveeno Face Milk SPF 40+|Sunscreen to be applied after application of face moisturizer and eye cream in the morning. Participants were asked to apply the sunscreen if sun exposure was more than 30 minutes per day.
15743684|NCT04911361|Drug|Dexamethasone|Patients will be randomized for either topical loteprednol suspension in both eyes (control group) or lower eyelid canaliculi DEXTENZA insertion (study group)
15743685|NCT04911348|Other|none (observational)|no intervention
15743686|NCT04911335|Combination Product|Faringel plus and oral hygiene|The expected frequency of administration of the study product is 2 / day, 10 minutes 'before main meals, for patients without mucositis (grade 1 according to the OAG scale, total score = 8). The frequency of administration will increase to 3 / day for patients with mild or moderate mucositis (grade 2 on the OAG scale, total score 9-18) and up to 4 / day in cases of severe mucositis (grade 3 on the OAG scale, score total 19-24). Each administration will contain 7 ml of oral suspension, to be kept inside the oral cavity for 1-2 minutes and then swallowed slowly.
15743687|NCT04911322|Device|ultrasonography|"A full obstetric ultrasound scan will be performed to assess signs of placental invasion, to document fetal biometry, estimated fetal weight, amniotic fluid index, assess fetal lung maturity parameters as pulmonary artery Doppler waveforms, amniotic fluid free floating particles, bowel echogenicity, fetal epiphyseal ossific centers, liver/lung echogenicity and kidney length.
~Pulmonary artery Doppler: Fetal echocardiography will be done. Pulmonary artery Doppler ﬂow waveforms, including pulsatility index, resistance index, systolic-to-diastolic ratio, peak systolic velocity, and acceleration time to ejection time ratio will be measured in the main pulmonary artery."
15743688|NCT04911309|Other|functional exercise training|12 weeks functional exercise training twice per week, each session lasting 60 min
15743689|NCT04911309|Other|standard therapy / treatment|12 weeks standard therapy / treatment
15743690|NCT04911296|Other|Mock-RP|Standard 000 capsule filled with potato starch, enteric-coated with colorant and lubricious coating.
15743691|NCT04911283|Other|Brucella serology test|MCs type 1 and type 2 patients were examined in terms of Brucella serology by using agglutination with Coombs test.
15743692|NCT04911283|Other|Medical history for brucellosis|Both of the MCs groups and healthy controls were investigated for their medical history regarding brucellosis.
15743696|NCT04911244|Diagnostic Test|bronchoalveolar lavage|endobronchial sampling through bronchoscopy
15743699|NCT04911205|Other|Preoperative training program|Patients of intervention group (N=44) followed a 6-week supervised high-intensity preoperative training program. They had a session of preoperative resistance training five days per week for a period of 6 weeks before TKA. Each session was supervised by a physiotherapist specifically trained in progressive resistance training. The duration of each session was approximately 60 minutes. If a participant missed a training session, it was attempted to substitute the session on an alternative day.
15743700|NCT04911192|Procedure|mechanical fragmentation|patients who will be treated with catheter-directed mechanical fragmentation under fluoroscopy guidance. This group will include patients with absolute contraindication for fibrinolytic therapy
15743701|NCT04911192|Procedure|In Situ thrombolysis|Group (C) will include the patients who will be treated with bed side administration of low dose of local thrombolytic therapy (In Situ) via a trans-Jugular Swan-Ganz pulmonary artery catheter. with guidance of the pressure waveforms obtained from SGC (Swan-Ganz catheter) and echocardiography guidance for ideal Catheter placement. This group will include the patients with relative contraindications for systemic thrombolysis, contraindications for contrasted administration (patients with renal impairment) and also patients with contraindications for radiation exposure (pregnant women).
15743702|NCT04911179|Other|Vivfrail-Cog combined multicomponent physical exercise and cognitive stimulation.|"The areas to be worked on are: Attentional system: selective attention and concentration; alternating attention / dual attention; Processing speed; perceptual organization; working memory and cognitive flexibility; comprehension, abstraction and verbal reasoning, planning, execution, and problem solving.
~Four programs have been developed stimulation different difficulty levels to adapt to the capabilities of each participant."
15743703|NCT04911166|Combination Product|Atezolizumab and Interleukin-12 Gene Therapy|To determine the safety and tolerability of the atezolizumab and ADV/IL-12 gene therapy combination in patients with metastatic NSCLC who have disease progression after a prior line of either single agent immunotherapy or a regimen of chemoimmunotherapy.
15743704|NCT04911140|Radiation|Photobiomodulation twice a week|The photobiomodulation will be applied with a LED facial mask, Cosmedical brand (São Paulo, Brazil), containing 92 red LEDs, 660 nm of wavelength, in continuous mode for 20 minutes, twice a week, for 4 weeks.
15743705|NCT04911140|Radiation|Photobiomodulation three times a week|The photobiomodulation will be applied with a LED facial mask, Cosmedical brand (São Paulo, Brazil), containing 92 red LEDs, 660 nm of wavelength, in continuous mode for 20 minutes, three times a week, for 4 weeks.
15743706|NCT04911140|Other|Simulated Photobiomodulation|Photobiomodulation will be simulated, with the device turned off, twice a week, for 4 weeks. The characteristic sound of the device will be triggered by recording.
15743707|NCT04911127|Drug|200mg Cannabidiol by capsules twice daily|200mg twice daily via 50mg capsules
15743708|NCT04911127|Drug|400mg Cannabidiol by capsules twice daily|400mg twice daily via 50mg capsules
15743709|NCT04911127|Drug|Placebo capsules|MCT oil capsules as placebo for CBD
15743710|NCT04911114|Behavioral|Be-Balanced|The BE-BALANCED program will run for 12-weeks, with participants attending group-based virtual supervised exercise sessions twice weekly. Participants will complete an individual in-person assessment at baseline and again at end of intervention to collect physical outcome measures and will complete questionnaires electronically using REDCap, (or mailed version). Follow-up assessments will be administered electronically to each participant using REDCap at 3-months after program completion (24 weeks post-baseline).
15743711|NCT04911101|Device|Excision with 7G needle|Vacuum-assisted excision using a biopsy needle with two alternative dimensions
15743712|NCT04911101|Device|Excision with 10G needle|Vacuum-assisted excision using a biopsy needle with two alternative dimensions
15743713|NCT04911075|Drug|85% TCA Solution|"TCA is an acetic acid analogue solution (CCl3COOH) which is formed from the reaction of acetic acid (CH3COOH) with chlorine (3Cl2).
~High concentrations (85 percent) of this solution can penetrate deeply into the epidermis-dermis layer and cause cells necrosis.
~This solution (1-2 milliliter) will be applied to participants cervical tissue (ectocervix and endocervix) using cotton swab for 1-3 minutes."
15743714|NCT04911062|Drug|Bupivacaine HCI without epinephrine|75 mg administered via injection into the surgical site.
15743715|NCT04911062|Drug|HTX-011|HTX-011 (bupivacaine/meloxicam) dose up to 200 mg/6 mg administered via application into the surgical site.
15743716|NCT04911062|Drug|HTX-011|HTX-011 (bupivacaine/meloxicam) dose up to 400 mg/12 mg administered via application into the surgical site.
15743717|NCT04911062|Device|Luer Lock Applicator|Applicator for instillation.
15743719|NCT04911036|Other|Questionnaires|Perinatal PTSD Questionnaire State Trait Anxiety Inventory-forme Y-B Early Support Questionnaire Socio-demographic questionnaire
15743720|NCT04911010|Behavioral|Prolonged Exposure|In the intervention condition, patients are treated with prolonged exposure in 16 hours of individual therapy immediately after the baseline measurement. The 16 individual therapeutic sessions take place 1 to 2 sessions per week over a period of 7 to 16 weeks. The individual therapeutic sessions are recorded on video with camera focus on the therapist. Parts of the prolonged exposure procedure (reliving the traumatic memory) are recorded on tape (via the patient's personal smartphone) so that the patient can listen to the recording as homework at home. The patients then take part in a post-treatment study diagnosis (T1).
15743721|NCT04910997|Other|Aerobic exercise training|Combination of supervised and home-based aerobic exercise training
15743722|NCT04910984|Behavioral|Chatbot messages|Automated personalized messages containing HIV testing-related information, motivation and skills
15743723|NCT04910984|Behavioral|Attention-matched educational materials|Attention-matched educational materials manually sent by our research assistant. These educational materials will be retrieved from CDC and WHO websites and curated into short articles (<200 words) and pictures. All educational materials will be screened by HIV experts from University of Malaya to ensure accuracy before being sent to participants.
15743724|NCT04910945|Device|VENUS AIME (RoboCor)|VENUS AIME is a micro-coring device of the skin that can potentially help to reduce visible skin scarring, improve skin laxity and reduce wrinkles.
15743725|NCT04910932|Other|Breathing Exercises|Breathing exercises including diaphragmatic breathing, thoracic expansion and breathing control exercises
15743726|NCT04910932|Other|Information on COVID-19|"Information about COVID-19 based on the advices in COVID-19 advice for the public section of World Health Organization website."
15743729|NCT04910906|Device|Ectoin® Vaginal Gel|"Ectoin® Vaginal Gel is a clear, non-hormonal moisturizing gel containing only active ingredient Ectoin® for the relief of vaginal dryness/vaginal atrophy.
~Other excipients in the formulation include:
~Hydroxyethylcellulose (Gelling agent) Lactic acid (90 %) (pH stabiliser) DL-Sodium lactate (Buffer substance) Sodium benzoate (preservative) Propylene glycol (Humectant)"
15743730|NCT04910893|Device|Cytokine Adsorption|Cytokine adsorption therapy will be provided continuously for 72 hours by means of the CytoSorb® (CytoSorbents Corporation, Monmouth Junction, USA) column, run in series to a veno-venous continuous hemodialysis system, which will be exchanged every 24 hours.
15743731|NCT04910893|Other|Standard of Care|Standard intensive care of patients suffering septic shock
15743732|NCT04910867|Behavioral|Components of Genetic Counseling|"The APOL1 testing program is designed to help living donor candidates to reduce their decisional conflict and enhance their informed consent regarding living donation. This intervention component entails: (1) an artificial intelligence-based conversational agent chatbot providing foundational information about the relationship between APOL1 and kidney disease and living donor outcomes, and APOL1 testing. The chatbot helps to relieve the workload on clinicians and scale up information giving. (2) The transplant nephrologist counseling component includes discussion about the APOL1 test results and shared decision making about donation, in a culturally competent manner, so as to enhance donor candidates' informed consent for living donation."
15743733|NCT04910867|Diagnostic Test|APOL1 genetic testing|APOL1 genetic testing will be performed while live kidney donor candidates are undergoing donor evaluation to identify whether they are at elevated risk of kidney disease post-donation. This risk information is expected to better enable donor candidates to make meaningful informed decisions about donating.
15743897|NCT04909580|Behavioral|Decision coaching with a patient decision aid|Decision coaching guided by the Ottawa Decision Support Framework
15743734|NCT04910867|Other|EHR integration|APOL1 genetic test results will be integrated into the electronic health record to provide clinical decision support to transplant nephrologists in evaluating donor candidates.
15743735|NCT04910854|Drug|Surufatinib|Patients receive oral Surufatinib at a dose of 300mg/d (once-daily dosing continuously, every 28-day treatment cycle), The curative effect was evaluated every 8 weeks.
15743736|NCT04910841|Device|CGM GUARDIAN 2|continuous blood glucose monitoring system
15743737|NCT04910828|Other|Common foods of varying glycemic indices|Examples of foods of varying glycemic index to be tested include bread, rice, breakfast cereals, starchy vegetables, legumes, fruit and dairy products.
15743738|NCT04910815|Device|Atmo Gas Capsule|The Atmo gas capsule is an ingestible electronic device. This capsule consists of gas and temperature sensors, electronic circuits, radio transmitter and silver oxide batteries. It can measure the concentrations and types of intestinal gases in individuals and give an indication of gut transit time. This data is used for research purposes to gain an understanding of the microbiota's localised functionality. The data from the sensors is transmitted out of the body over the radio frequency to a handheld receiver. The capsule passes out of the human body at the end of the measurement and is disposable.
15743739|NCT04910815|Diagnostic Test|Glucose Breath Test|Glucose is a sugar that will be broken down by bacteria if present in the small bowel with hydrogen gas as a by-product. The hydrogen produced through fermentation is measured in the patients exhaled breath
15743740|NCT04910815|Diagnostic Test|Fructoolifosaccharides (FOS) Breath Test|FOS is a long chain carbohydrate that can only be broken down by bacteria with hydrogen gas as a by-product. The hydrogen produced through fermentation is measured in the patients exhaled breath
15743741|NCT04910815|Procedure|Jejunal Aspiration and culture|Endoscopic procedure to determine microbial load of the Small bowel. This is the gold standard to determine the Active SIBO cases
15743742|NCT04910815|Drug|Rifaximin|Rifaximin (550g) 1 capsule twice a day for 14 days.
15743743|NCT04910815|Drug|Placebo|randomised administration of either placebo or Rifaximin (550g) 1 capsule twice a day for 14 days. The placebo will be encapsulated maize starch and pregelatinised maize starch
15743744|NCT04910802|Biological|Gardasil9|Concomitant vaccination and HPV screening. Gardasil9 will be administered using standard dosage. 1 dose at recruitment and the 2nd dose 3 years later.
15743745|NCT04910789|Procedure|transhiatal/transabdominal approach|Radical surgery should be finished via transhiatal/transabdominal approach
15743746|NCT04910789|Procedure|thoracoabdominal approach|Radical surgery should be finished via thoracoabdominal approach
15743747|NCT04910776|Drug|avalglucosidase alfa|Sterile lyophilized powder intravenous (IV) infusion
15743748|NCT04910763|Behavioral|Resistance Exercise|Increasing strength and fitness and thereby influencing hormones and perceptions involved in appetite regulation.
15743751|NCT04910737|Procedure|extended posterior circumferential decompressive surgery|After the pedicle screws were implanted, laminectomy was performed. Kyphotic correction was done through a temporary rod to reduce the tension of spinal cord. The posterior 1/3 of the vertebral body was resected using a high-speed drill, preserving the anterior wall of the spinal canal to protect the cord from disturbance. The dissection of adhesion at the anterior side of spinal cord was to be done through a posterolateral direction. The region of posterior resection was expanded, including bilateral residual articular processes, transverse processes and pedicles. Slightly press down the ossified lesion, and detach it from the dura mater (perform a sharp dissection if necessary) followed by completely removal. If cerebrospinal fluid leakage was encountered during the process, autologous fat, fascia or gelatin sponge can be applied locally for packaging.
15743752|NCT04910724|Other|Energy Deficit|A combination of individualized exercise performed on a cycle ergometer and individualized dietary prescriptions will be used to achieve energy balance or the assigned energy deficits throughout the controlled feeding and testing periods
15743753|NCT04910711|Drug|Dolutegravir|Dolutegravir-based antiretroviral therapy
15743754|NCT04910711|Drug|Levonorgestrel implant|Women initiating the levonorgestrel implant
15743755|NCT04910711|Drug|Depo medroxyprogesterone acetate injection|Women initiating the depo medroxyprogesterone acetate injection
15743756|NCT04910698|Drug|Antibiotic|Antibiotic duration of treatment defined if the patient belonged to long course or short course group.
15743757|NCT04910685|Drug|BLU-263|BLU-263 tablet
15743758|NCT04910685|Drug|Placebo|Placebo Tablet
15743759|NCT04910672|Other|Control Group|"Bilateral global pelvic manipulation. Lower right limb in extension. The left lower limb in flexion, until the tension on the SPIS was felt. Introduce very little rotation of the spine. ASI anterior slide until crease forms at waist.
~We bring the elbow towards our hips. We rotate the patient posteriorly to open the lumbo sacral facet. The thrust is performed by simultaneously increasing these three parameters, with kick and joint compression."
15743760|NCT04910672|Other|Experimental Group|"Bilateral Global Pelvic Manipulation and Internal Correction Technique for Laterflexion of the Uterus The technique consists of making contact with the vaginal fingers on the upper and anterior part of the cervix, while the abdominal hand, dragging the skin towards the pubis, tries to make contact as posterior as possible on the fundus of the uterus. The technique consists, while the patient breathes widely, in progressively raising the uterine fundus forward and upward and lowering the cervix until the normal anteversion position is achieved.
~At the end of the technique, fixing the correction position of the uterus, we can ask the patient to perform a pelvic anteversion, while the correction is maintained. At the end of the technique, all abnormal tension should have disappeared and the uterus should have recovered a physiological position of anteversion."
15743761|NCT04910659|Other|acupuncture|P6, LI4 and LI 11 stimulation
15743762|NCT04910646|Drug|orange peel fermentation|To evaluate whether the fermented orange peel enzyme has the effect of reducing body fat.
15743763|NCT04910646|Drug|Placebo|Placebo without orange peel fermentation
15743898|NCT04909567|Behavioral|Optimisation|Defined optimisation
15743899|NCT04909541|Other|CEGSSS-Canadian Endourology Group Stent Symptom Score|Patient with ureteral stent complete the Canadian Endourology Group Stent Symptom Score (CEGSSS)
15743764|NCT04910633|Other|COCA is an observational study based on retrospective data issued from patient medial file.|"The following parameters will be collected from the medical files of the patients involved in this study:
~Age
~Gender
~Cancer type
~Cancer Stage
~Cancer Treatment
~COVID-19 severity (based on chest X-Ray damage. Low ≤25%, Middle: between 25-50%, High above 50%)
~Living Status
~Attribution of Mortality to COVID status
~Comorbidities"
15743765|NCT04910620|Drug|Placebo|Placebo only
15743766|NCT04910620|Drug|TCI378|TCI378 (Lactobacillus plantarum TCI378)
15743767|NCT04910620|Drug|TCI507|TCI507 (Lactobacillus plantarum TCI507)
15743768|NCT04910607|Other|Questionnaire|"Questionnaire with 4 axes:
~sociological, reflexive medical, prospective medical, transversal"
15743769|NCT04910607|Other|Interview|Interview concerning health pathways, experience of confinement, consequences of confinement on health, representations of obesity.
15743770|NCT04910594|Drug|recombinant human erythropoietin|To determine the efficacy and safety of recombinant human erythropoietin in improving anemia in patients with lymphoma, and to improve the quality of life and the efficacy of chemotherapy in patients with lymphoma.
15743771|NCT04910581|Procedure|rTMS|Single 30-minutes session of 1Hz rTMS applied over the left laryngeal motor cortex
15743772|NCT04910581|Procedure|Sham stimulation|Single 30-minutes session of sham stimulation applied over the left laryngeal motor cortex
15743775|NCT04910555|Other|strong desire to void - cognitive task|Strong desire to void - cognitive task (verbal fluency)
15743776|NCT04910542|Other|Epi-Net Intervention|The Epidemiological Intelligence Network Intervention (Epi-Net) is a group of field epidemiology tools for test, trace and isolate using a community-based approach. The overall goal of Epi-Net is to increase uptake of COVID-19 testing and prevention practices among socially vulnerable communities in Puerto Rico. The intervention intends to impact COVID-19 risk perception, decrease COVID-19 testing barriers, increase testing uptake and increase health promotion strategies.
15743777|NCT04910529|Other|Yoga|Hatha yoga, which is one of the most basic yoga methods, will be applied to the students in the study. During each practice within the scope of Hatha yoga, students; breathing exercises, relaxation techniques and warm-up exercises will be applied respectively. In addition to these, asanas (yoga postures) with balance, stretching, relaxation and strengthening components will be applied to the students.
15743778|NCT04910516|Behavioral|Emotional Freedom Techniques (EFT)|It combines cognitive therapy, acceptance and stability therapy, and acupuncture point stimulation, and is based on manual stimulation of acupuncture points specific to Shiatsu or other acupressure massage fo
15743779|NCT04910503|Drug|Dexamethasone intravitreal implant|Implant every 4 months if necessary
15743780|NCT04910503|Drug|Fluocinolone Acetonide Intravitreal Implant|Implantation
15743781|NCT04910490|Other|No interventions - retrospective data collection|No new/additional patients will be enrolled within this project.
15743782|NCT04910477|Drug|Dexmedetomidine|ultrasonic nebulization of dexmedetomidine (1 mg/kg diluted in 4 mL saline) twice daily for three days.
15743783|NCT04910477|Drug|Neostigmine/atropine|nebulization of 20 µ/kg neostigmine and 10 µ/kg atropine mixed in 4 ml) twice daily for three days.
15743784|NCT04910477|Other|Saline placebo|nebulization of saline placebo in 4 ml) twice daily for three days.
15743785|NCT04910464|Drug|Tranexamic acid|administer 1 gram of TXA in 100 ml of 0.9% normal saline, intravenous over 10 minutes as soon as possible but no later than three hours after diagnosis, infuse a second gram of TXA IV over 8 hours in 0.9% normal saline for first 3 days.
15743786|NCT04910464|Other|0.9% saline|administer the same volume (100ml normal saline) and same duration (first three days).
15743787|NCT04910451|Other|No Intervention|
15743788|NCT04910438|Other|STIs screening and care|"Screening for anal dysplasia, HPV infection, HIV infection and several STIs (Neisseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma genitalium, Trichomonas vaginalis, HSV-2 and HBV).
~Offering comprehensive care including prevention strategies adapted to the various STIs mentioned above and their complications, particularly the progression to anal cancer for HPV infections in MSM."
15743789|NCT04910425|Drug|Fluorine F 18 DCFPyL|Given IV
15743790|NCT04910425|Drug|Gadobenate Dimeglumine|Given IV
15743791|NCT04910425|Drug|Gadobutrol|Given IV
15743792|NCT04910425|Procedure|Magnetic Resonance Imaging|Undergo PET/MRI
15743793|NCT04910425|Procedure|Multiparametric Magnetic Resonance Imaging|Undergo mpMRI
15743794|NCT04910425|Procedure|Positron Emission Tomography|Undergo PET/MRI
15743795|NCT04910425|Procedure|Transrectal Ultrasonography Guided Biopsy|Undergo TRUS-guided biopsy
15743796|NCT04910412|Device|transcranial direct current stimulation|Transcranial direct current stimulation will be use for the intervention. Anodal and sham tDCS will be applied in 2 mA through a pair of saline-soaked surface sponge electrode 35 cm square for 20 minute over the primary motor area for modulating the cortical excitability before apply the rehabilitation training
15743797|NCT04910399|Dietary Supplement|Blue fish hydrolysate|"The experimental product is a dietary supplement composed of a hydrolysate of fatty blue fish containing low molecular weight peptides and n-3 polyunsaturated fatty acids.
~One of the two study groups (28 volunteers) will take 4 capsules of the active product (blue fish hydrolysate), for 90 days.
~Each day the capsules will be taken as followed : 2 capsules in the morning and 2 capsules in the evening."
15743798|NCT04910399|Dietary Supplement|Placebo|"The placebo product containing mainly maltodextrin is presented in the same form as the active product, so that people handling the product cannot distinguish between them. The placebo is flavoured in order to have a fishy smell just like the active product.
~One of the two study groups (28 volunteers) will take 4 capsules of placebo per day, for 90 days.Each day the capsules will be taken as followed : 2 capsules in the morning and 2 capsules in the evening."
15743799|NCT04910386|Drug|Envafolimab plus Gemcitabine&Cisplatin|Envafolimab a programmed death ligand immune check inhibitor Per Investigator decision
15743800|NCT04910386|Drug|Gemcitabine&Cisplatin|The standard of care for the patients with unresectable/metastatic biliary tract cancer
15743801|NCT04910373|Other|Experimental Extensively Hydrolyzed Formula|experimental powder formula
15743802|NCT04910373|Other|Placebo Extensively Hydrolyzed Formula|placebo powder formula
15743803|NCT04910347|Drug|Nivolumab|"Dosage within 12 weeks after the end of concurrent chemoradiation therapy. Nivolumab 360mg Intravenously administered every 3 weeks.
~As a consolidation regimen, administration of Nivolumab is administered for up to a total of 1 year until disease progression or unacceptable to toxicity occurs."
15743804|NCT04910321|Other|diet, physical activities, sleep|lifestyle factors
15743805|NCT04910308|Radiation|FDG-PET guided dose painting|The radiation dose inside the gross tumor volume is increased according to the voxel intensity (SUV - standardized uptake value) of pre-treatment FDG PET.
15743806|NCT04910295|Drug|COVID-19 vaccine|Subjects will be vaccinated with COVID-19 vaccines approved in Korea. Data on specific vaccines will be gathered.
15743807|NCT04910269|Biological|Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG)|The hIVIG product is administered as a single dose of 30 grams, or 300 milliliter at a concentration of 0.1 grams/milliliter. This dose corresponds to 400 milligrams/kilogram for a 75 kilogram adult.
15743808|NCT04910269|Other|Placebo|Infusion of standard isotonic saline
15743809|NCT04910256|Drug|HuaTuo Zaizao pill|Patients take 8g of HuaTuo Zaizao pill three times a day. Treatment lasts for 12 weeks.
15743810|NCT04910256|Other|basic treatment|"It accordance with the Guidelines for diagnosis and treatment of ischemic stroke in China,and the drug and dosage will be formulated by the researchers according to the clinical situation."
15743812|NCT04910230|Drug|nicotinamide|In addition to usual care, the treatment group was given 500mg nicotinamide daily, divided into 5 doses
15743813|NCT04910217|Procedure|Conventional rehabilitation|Patients will undergo conventional rehabilitation
15743814|NCT04910217|Procedure|Leg/lower body exerciser device intervention.|Patients will undergo leg/lower body exerciser device therapy.
15743815|NCT04910217|Procedure|Lokomat intervention|Patients will undergo therapy with Lokomat Pro FreeD device intervention.
15743816|NCT04910204|Other|FES Therapy combined with task-specific training (FEST+TST)|The FEST+TST protocol consists of a 1-hour session, 3 to 5 days a week, for up to 12 weeks (40 sessions total) in addition to conventional occupational and physical therapies according to the standard of care.
15743817|NCT04910191|Diagnostic Test|Electronic stethoscope|Electronic stethoscope
15743818|NCT04910178|Drug|Empagliflozin 25 MG|tablets to be taken orally once a day
15743819|NCT04910178|Drug|Ursodeoxycholic acid|tablets to be taken orally twice a day
15743820|NCT04910178|Drug|Pentoxifylline 400 MG|tablets to be taken orally twice a day
15743821|NCT04910178|Other|placebo|just starch tablets without any active agents
15743822|NCT04910165|Drug|Exparel|Exparel used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
15743823|NCT04910165|Drug|Ropivacaine|Ropivacaine used in Adductor Canal Block plus Infiltration Between Popliteal Artery and Capsule of Knee using Ropivacaine
15743824|NCT04910152|Drug|BRD4 Inhibitor PLX51107|Given PO
15743825|NCT04910139|Device|Soniflow System|Treatment using acoustic vibrational headband worn circumferentially at the level of the forehead paired with a Smartphone App.
15743826|NCT04910126|Drug|Camrelizumab|Camrelizumab 200mg q3w up to 2 years
15743827|NCT04910126|Drug|Adriamycin|adriamycin 20mg/m2 d1-3 q3w maximum 6 cycles
15743828|NCT04910100|Drug|Nebivolol Ophthalmic Suspension 1 Percent|1 drop instilled into each eye twice daily
15743829|NCT04910100|Drug|Nebivolol Ophthalmic Suspension 0.5 Percent|1 drop instilled into each eye twice daily
15743830|NCT04910100|Drug|Timolol Ophthalmic Suspension 0.5 Percent|1 drop instilled into each eye twice daily
15743831|NCT04910100|Drug|Timolol Ophthalmic Solution 0.5 Percent|1 drop instilled into each eye twice daily
15743832|NCT04910087|Diagnostic Test|Sonographic optic nerve sheath diameter measurement|With the linear ultrasound probe operating at 11 MHz in B mode, it will be measured in 2 planes, 3.0 mm behind the optic disc, the transverse plane where the probe is placed horizontally and the sagittal plane where the probe is placed vertically. Then, the average of these measurements will be recorded for both eyes every 10 minutes.
15743833|NCT04910074|Device|Low-level laser therapy|The proposed LLLT protocol will use the Biolase Epic X, an InGaAsP diode laser (940nm) using the pain relief handpiece, a device which has received FDA approval (GUDID 00647529002537) for the treatment of pain, muscle relaxation and healing via increased local circulation. The LLLT will be administered to the experimental group at 30 j/cm2. The laser will be applied extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
15743834|NCT04910074|Device|Dummy LLLT|The Biolase Epic X with pain relief handpiece will be applied with no power extraorally, on the skin overlying the mandible. Application will be for 40 seconds per side, with 10 seconds administered in four places along the jawline, 1 cm apart starting from the gonial angle.
15743835|NCT04910061|Dietary Supplement|Nicotinamide mononucleotide (NMN-C)|Daily supplementation with NMN-C at 400 mg for 29 days in total
15743836|NCT04910048|Other|POPOP (preoperative patient optimization program)|A 2 month structured program focused on reduction of BMI, body weight, visceral fat, body fat and improvement of lean body mass and intracellular fluid.
15743837|NCT04910048|Other|SOC (standard of care)|Referral to a dietician for two months of self-directed weight loss
15743838|NCT04910035|Other|Exercises Training|SSE is performed on a thin exercise mat divided into 40 small squares in 250 cm x 100 cm of size (25 cm each part). Participants are given patterns of a few steps and asked to take steps that match them. Participants must, in principal, move ahead in line with the length forward with no contact on the lines forming the squares. Forward, backward, lateral and oblique stepping patterns are required. Stepping patterns get increasingly difficult. Each pattern consists of 2 to 16 steps; participants are asked to repeat step pattern till the end of exercise mat. Upon completing a pattern, another pattern in the same mirror-image is repeated. In essence each pattern is reiterated for 3-5 times and next its mirror-image pattern is repeated but if participants face challenge in performing the pattern it is repeated till the pattern is learnt
15743927|NCT04909320|Behavioral|E-messages via SMS|Regular e-messages via SMS at twice per month within 3 months (total 6).
15744025|NCT04908605|Drug|Mirtazapine|Every patient will be given mirtazapine 30 mg tablet
15743839|NCT04910022|Drug|NMS-03305293 + TMZ|NMS-03305293 will be administered orally for 7 consecutive days from Day 1 to Day 7 of each treatment cycle. TMZ will be administered orally once daily for 5 consecutive days from Day 1 to Day 5 of each treatment cycle. A treatment cycle duration is 28 days (a 4-week period).
15743840|NCT04910022|Drug|NMS-03305293 + TMZ|Patients will receive NMS-03305293 at the RP2D with the escalating dose of TMZ used as standard of care for newly diagnosed glioblastoma patients.
15743841|NCT04910022|Drug|Lomustine|Patients will receive lomustine orally on day 1 of each 6-week cycle.
15743842|NCT04910022|Drug|NMS-03305293 + TMZ|NMS-03305293 will be administered orally for 7 consecutive days from Day 1 to Day 7 of each treatment cycle. TMZ will be administered orally once daily for 5 consecutive days from Day 1 to Day 5 of each treatment cycle. A treatment cycle duration is 28 days (a 4-week period).
15743843|NCT04910009|Other|Four sessions of practical privacy education|Two sessions of theoretical, four sessions of practical privacy education
15743844|NCT04909996|Device|Sentinox--Group A|"GROUP A: Sentinox treatment performed 3 times/day for 5 days (as addon to the standard therapy) at 8am, 2pm and 8pm;
~The application of IP on should be performed in accordance to the following indication:
~The treatment is administered in a dose of 0.5 ml into each nostril (5 sprays) per the number of times per day according the trial group assigned according the randomization procedure (i.e., GROUP A: 3 times/day; GROUP B: 5 times/day; GROUP C: no IP treatment)."
15743845|NCT04909996|Device|Sentinox--Group B|"GROUP B: Sentinox treatment performed 5 times/day for 5 days (as addon to the standard therapy) at 8am, 11am, 2pm, 5pm and 8pm;
~The application of IP on should be performed in accordance to the following indication:
~The treatment is administered in a dose of 0.5 ml into each nostril (5 sprays) per the number of times per day according the trial group assigned according the randomization procedure (i.e., GROUP A: 3 times/day; GROUP B: 5 times/day; GROUP C: no IP treatment)."
15743846|NCT04909983|Device|DPLX-PT1|A polymer skin patch for occlusional therapy
15743847|NCT04909983|Other|Control arm|Standard of care
15743848|NCT04909970|Other|Self-hypnosis|Self-hypnosis training during 8 weeks and one daily self-hypnosis session during 8 weeks
15743849|NCT04909970|Other|Control (Waiting list)|Usual practice during the first 16 weeks. At the end of study, the participant will practice Self-hypnosis training during 8 weeks and one daily self-hypnosis session during 8 weeks
15743850|NCT04909944|Device|i-gel Supraglottic insertion|i-gel Supraglottic insertion for oxygenation
15743851|NCT04909944|Device|Laryngeal Tube Suction Disposable Supraglottic insertion|Laryngeal Tube Suction Disposable Supraglottic insertion for oxygenation
15743852|NCT04909931|Drug|Vitamin D 2|Randomized allocation first arm : add on vitamin D supplementation 40,000 iu/week for 12 weeks
15743853|NCT04909931|Drug|Placebo|Second arm : add on placebo for 12 weeks
15743854|NCT04909918|Drug|Dexamethasone|Baseline laboratory & clinical data will be taken before and after the study drugs according to our protocol.Intravenous dexamethasone 8 mg/day given for 7 days
15743855|NCT04909918|Drug|Methylprednisolone|Baseline laboratory & clinical data will be taken before and after the study drugs according to our protocol. Intravenous methylprednisolone 1 mg/kg/day in 2 divided doses per day given for 7 days
15743856|NCT04909905|Dietary Supplement|Standard enteral nutrition|Standard enteral nutrition according to ICU nutrition protocol for 7 days
15743857|NCT04909905|Combination Product|Glutamine|Intravenous glutamine supplementation to enteral nutrition in a dose of dose of glutamine of 0.4 g/kg/day for 7days
15743858|NCT04909892|Biological|COVI-MSC|COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells
15743859|NCT04909879|Biological|COVI-MSC|COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells
15743860|NCT04909879|Drug|Placebo|Excipient solution
15743861|NCT04909866|Combination Product|TACE+Lenvatininb+Camrelizumab|Patients included in the trial were treated with TACE, lenvatinib combined with Camrelizumab.
15743862|NCT04909853|Drug|PF-07321332/ritonavir|PF-07321332 in combination with the PK boosting agent, ritonavir, being developed for the treatment of COVID-19
15743863|NCT04909840|Other|Instructions oral hygiene with toothbrush plus dental floss|Instructions of oral hygiene with toothbrush plus dental floss
15743864|NCT04909840|Other|Instructions oral hygiene with toothbrush only|Instructions only with toothbrush
15743865|NCT04909827|Procedure|3D-printed endocrown|pulpotomy and restoration with 3D-printed microfilled hybrid composite endocrown
15743866|NCT04909827|Procedure|Zirconia crown|pulpotomy and restoration with prefabricated zirconia crown
15743867|NCT04909814|Biological|The performance of colposcopy in vaccinated women|Evaluating the performance of colpscopy in HPV vaccinated women by comparing vaccinated and unvaccinated women taking their first test within the organized screening program
15743868|NCT04909801|Drug|Abatacept|Abatacept SC (125 mg) once weekly
15743869|NCT04909801|Drug|Adalimumab|Adalimumab SC (40 mg) once every 2 weeks
15743870|NCT04909801|Drug|Methotrexate|Methotrexate oral/parenteral maximum tolerated dose (minimum 15 mg and maximum 25 mg weekly)
15743871|NCT04909788|Behavioral|a long-distance running (over 3 km)|Complete a long distance running（over 3 km） within the specified time (30 minutes)
15743872|NCT04909775|Drug|Tislelizumab|200 mg per cycle, IV on day 1 of 3-week
15743873|NCT04909775|Drug|Cisplatin|70mg/m2 IV on Day 1 of 3-week, for 4 cycles. Dose fractionation is permissible.
15743874|NCT04909775|Drug|Gemcitabine|1000mg/m2, Day 1 and Day 8 of 3-week, for 4 cycles
15743875|NCT04909762|Other|Early Rehabilitation and Mobilisation (ERM)|Early rehabilitation/mobilisation (ERM) encompasses patient-tailored interventions, delivered individually or in a bundled package. It is provided by health professionals from multiple disciplines and care-givers within intensive care settings.
15743894|NCT04909606|Other|nurse-led prevention program|"Subjects randomized to the nurse-led prevention program group will be evaluated by the dedicated nurse within 2 weeks following randomization (individual assessment)
~The nurse-led prevention program will include:
~A video explaining corticosteroids related adverse events and adequate preventive measures
~An individual interview with the trained nurse
~A consultation with a dietetician
~An individual sheet summarizing appropriate non-pharmacological preventive measures for the participant
~An individual sheet summarizing appropriate pharmacological preventive measures for the referent physician
~Phone calls at week-12, week-24 and week-36 to ensure the appropriate implementation of preventive measures"
15774935|NCT04655391|Drug|Gilteritinib Fumarate|Given PO
15743876|NCT04909749|Genetic|Oneome RightMEd Pharmacogenomic testing Kit|The RightMed test is an end-to-end solution which includes sample collection, pharmacogenomic (PGx) testing services, data analysis, and clinical interpretation that helps physicians select treatments based on evidence-driven predictions of patient drug response and tolerance. Genetic components of an individual's drug response are well established and often included on Food and Drug Administration (FDA) medication labels. The OneOme RightMed test has incorporated existing evidence to classify the risk and likelihood of an antidepressant working for different patients. Patient results for each medication can fall into one of three categories: 1.) Green - use as directed; 2.) Yellow - use with caution; and 3.) Red - adjust dose or choose alternative mediation and can be used proactively or reactively
15743877|NCT04909736|Other|Music Exposure|Music will be played for participants.
15743882|NCT04909710|Other|Mobile Game System for Potential Treatment of Developmental Delays|This mobile game system is designed to generate valuable data from video, image, and usage data for measuring progress and building novel artificial intelligence models while delivering impactful education for and treatment of children with developmental delays such as autism.
15743883|NCT04909697|Drug|Sivelestat sodium|4.8mg/kg sivelestat sodium was given in 50ml normal saline, and was continuously pumped in the dark for 24h, equivalent to 0.2mg/kg/h.Applied for 5 consecutive days
15743884|NCT04909697|Drug|Saline|50ml normal saline was continuously pumped in the dark for 24h. Applied for 5 consecutive days
15743885|NCT04909684|Drug|Pembrolizumab|The approved dose of pembrolizumab (200 mg every three weeks [Q3W] or 400 mg every 6 weeks [Q6W]) will be decreased to a 300 mg dose Q6W.
15743886|NCT04909671|Device|Gi Genius, Medtronic|GI geniusTM (Medtronic) is an artificial intelligence device designed and validated on a dataset of white-light endoscopy videos from high-quality randomized controlled trials for the detection of colorectal lesions during colonoscopy. Based on a deep learning system using convolutional neural networks, GI genius works in real-time side-to-side with the gastroenterologist during colonoscopy highlighting the presence of precancerous lesions with a visual marker (green box) in real time and designed to be integrated with the majority of colonoscopies.
15743887|NCT04909671|Other|White light standart colonoscopy|High definition white light endoscopy will be used during the scope withdrawal
15743888|NCT04909658|Behavioral|ACT Matrix|"The ACT protocol group performs exercises to improve the psychological well-being of parents. The matrix is an ACT protocol that is usually presented visually to patients and consists of two intersecting lines that make up four quadrants, which provide a point of view on one's psychological actions and experiences. The vertical line is the line of experience, the upper part corresponds to the experience of life linked to the five senses - sight, hearing, taste, smell and touch - (experience of the five senses), the lower part refers to the experiences internal as thoughts and feelings (internal/mental experience). The horizontal line is the behavior line, the left side concerns the actions that perform the function of moving us away from experiences, emotions, unwanted thoughts (experiential avoid-ance), the right side indicates the actions we take to get closer and go towards our values (committed action)."
15743889|NCT04909658|Behavioral|PT Protocol|The PT protocol group received behavioral tasks related to child management. Parent training interventions carried out in groups can be a good solution to modify parent behavior by providing social support and new coping strategies. The intervention includes 24 weekly meetings lasting 90 minutes each. The total intervention is six months.
15743890|NCT04909645|Diagnostic Test|Clearsight (finger cuff)|Clearsight (Edwards Lifesciences, Irvine, CA), a noninvasive technique, uses a finger cuff to measure blood pressure, cardiac output (CO) and cardiac index. Systemic vascular resistance (SVR) is calculated by the following equation: SVR=(Mean arterial pressure-Central venous pressure)*80/CO.
15743891|NCT04909632|Diagnostic Test|Liquid chromatography-mass spectrometry (LC-MS) analysis|The data were acquired by UNIFI software (Waters) and processed by UNIFI and Progenesis QI software. Omics analysis methods, such as principal component analysis (PCA), partial least squares-discriminate analysis (PLS-DA), and orthogonal partial least squares-discriminate analysis (OPLS-DA), were employed to identify the biochemical patterns in tongue coating samples and suggest variables that can be used as biomarkers for diabetes and pre-diabetes.
15743892|NCT04909619|Procedure|Ultrasound-guided bilateral suprazygomatic maxillary nerve block|The maxillary nerve, V2, is purely a sensory branch of the trigeminal nerve. V2 exits the skull through the foramen rotundum and courses through the pterygopalatine fossa, a small pyramid-shaped depression located posterior to the maxilla. As the maxillary nerve exits the pterygopalatine fossa, it divides into numerous branches that supply sensation to the posterior nasal cavity, palate, sinuses, and maxilla. It is within the pterygopalatine fossa that the maxillary nerve is targeted and anesthetized during the block. With the patient in the supine position after nasotracheal intubation, a needle is inserted perpendicularly between the upper border of the zygomatic arch and posterior orbital rim until it reaches the greater wing of the sphenoid, where the needle is then retracted by a few millimeters and redirected toward the nasolabial fold until it hits the pterygopalatine fossa.
15743893|NCT04909619|Procedure|Local anesthetic infiltration of the palate|Local anesthetic infiltration of the palate during cleft palate repair is universally practiced. The benefits of local anesthetic infiltration are twofold: to provide anesthesia to the terminal branches of the nasopalatine and greater palatine nerves that are in the immediate area of the injection sites and to achieve hemostasis during closure when the medication is mixed with epinephrine. To administer local anesthetic infiltration of the palate, a 25 gauge needle is inserted next to the incision into the soft tissue. The tissue is first aspirated to determine safety of injection at that site. The medication is then injected parallel to the incision on both sides.
15743895|NCT04909606|Other|Current care|Subjects randomized to the standard of care group will receive a general summary sheet of preventive measures associated with long term corticosteroids therapy (no individual assessment) in addition to the usual care provided by their physician
15743896|NCT04909593|Device|Spinal Cord Stimulation|Spinal cord stimulation at varied electrode, pulse width, frequency and amplitude parameters
15743900|NCT04909528|Device|Low-level tragus stimulation|Frequency: 20Hz; Pulse width: 0.2 ms; Current is based on the following: Determine the perception threshold (feeling tingling) at the time of baseline information assessment. Because of sensory adaptation, ask the patient 5 minutes later to increase the current by 1-5 mA. Try to find the current level below the discomfort level and above the perception threshold; Stimulation spot: ear tragus; Stimulation time: 30 min in the morning (from 6:00 a.m. to 9:00 a.m.) and 30 min in the evening (from 20:00 p.m. to 23:00 p.m.)
15743901|NCT04909528|Device|Sham stimulation|Frequency: 20 Hz; Pulse width: 0.2 ms; Current is based on the following: Determine the perception threshold (feeling tingling) at the time of baseline information assessment. Because of sensory adaptation, ask the patient 5 minutes later to increase the current by 1-5 mA. Try to find the current level below the discomfort level and above the perception threshold; Stimulate spot: ear lobe. Stimulation time: 30 min in the morning (from 6:00 a.m. to 9:00 a.m.) and 30 min in the evening (from 20:00 p.m. to 23:00 p.m.)
15743902|NCT04909515|Drug|Naxitamab|3.0 mg/kg/day = 9.0 mg/kg/cycle
15743903|NCT04909515|Drug|GM-CSF|250 - 500 microgram/m2/day
15743904|NCT04909515|Drug|Isotretinoin|160 mg/m2/day
15743905|NCT04909502|Drug|EHP-101 25 mg OD|25 mg OD during the first 28 Days of the trial
15743906|NCT04909502|Drug|EHP-101 25 mg BID|25 mg BID during the first 28 Days of the trial
15743907|NCT04909502|Drug|EHP-101 50 mg OD|After 28 Days of treatment with 25 mg OD, patients will escalate to 50 mg OD up to the end of the trial
15743908|NCT04909502|Drug|EHP-101 50 mg BID|After 28 Days of treatment with 25 mg BID, patients will escalate to 50 mg BID up to the end of the trial
15743909|NCT04909489|Other|cross-sectional study without intervention|cross-sectional study without intervention
15743910|NCT04909476|Procedure|Endotracheal intubation|Airways management in COVID 19 patients pneumonia
15743911|NCT04909463|Device|Chest Splint|Those receiving intervention will be given the Duracore chest splint for use throughout the trial.
15743912|NCT04909450|Biological|CSB-001 Ophthalmic Solution 0.1%|CSB-001: human recombinant dHGF (5-amino acid deleted hepatocyte growth factor)
15743913|NCT04909450|Biological|Vehicle Control|Matching vehicle control without the drug substance
15743914|NCT04909437|Dietary Supplement|Mycobiotic|1 sachet/day, 21 days, oral
15743915|NCT04909437|Dietary Supplement|Placebo|1 sachet/day, 21 days, oral
15743916|NCT04909411|Other|OPHTHALMOLOGICAL ASSESSMENT|assessment of eye mobility (search for heterophoria or strabismus), visual acuity, visual fields, external structures and funduscopic examination
15743917|NCT04909411|Other|NEUROPSYCHOLOGICAL ASSESSMENT|completion of WISC-5, Vineland Adaptive Behavior Scale II and Strengths and Difficulties Questionnaire
15743918|NCT04909398|Behavioral|Dynamic pupillometry sessions|"The evaluation protocol will include the following steps:
~Installation of the subject, adaptation of the chin rest for the best comfort of the participant
~Calibration of the oculometer consisting of ocular fixation of 9 fixation points distributed on the stimulation screen
~Final validation of the eligibility of the subject in the study according to the success or not of the calibration."
15743919|NCT04909372|Behavioral|Labelling|"Food products in the virtual supermarket will display an environmental label on their packaging, from A (lowest impact) to E (highest impact). The label categories are based on the Product Environmental Footprint, a score recommended by the European Commission that evaluates the environmental impact of a food product based on 16 indicators calculated throughout the life cycle of the products (e.g., climate change in kg carbon dioxide eq, marine eutrophication in kg N eq, land and water use or acidification in mol H+ eq).
~Instructions will introduce and explain the environmental label to the participants as In the virtual supermarket, each product will have an environmental label. This label describes whether a product had a negative impact on the environment (green house gaz emissions, water resources depletion, etc.) from A, lowest impact, to E, highest impact."
15743920|NCT04909333|Drug|Exenatide|"Day1: After a standardized night meal (Maizena 40g plus dessert) at 22 p.m. on the day before, patients receive Exenatide study medication according to the randomization list (injection done slowly over 5 min.). Regular clinical examination of vegetative and neurological state will be done as well as continuous blood sugar measurements and blood withdrawals will be performed.
~Day2:
~The procedure is equal to study day 1. Instead of Exenatide a 10ml 0.9% saline solution, will be administered intravenously."
15743921|NCT04909333|Drug|0.9% saline solution|"Day1: After a standardized night meal (Maizena 40g plus dessert) at 22 p.m. on the day before, patients receive 0.9% saline solution according to the randomization list (injection done slowly over 5 min.). Regular clinical examination of vegetative and neurological state will be done as well as continuous blood sugar measurements and blood withdrawals will be performed.
~Day2:
~The procedure is equal to study day 1. Instead of 0.9% saline solution, Exenatide will be administered intravenously."
15743922|NCT04909320|Behavioral|AWARD advice|Ask about smoking history; Warn about the high risk; Advise to quit; Refer smokers to smoking cessation services (with a referral card); Do it again
15743923|NCT04909320|Other|Brief leaflet on health warning and smoking cessation|The contents of the leaflet include (1) highlights of the absolute risk of death due to smoking; (2) the whole list of diseases caused by active and second-hand smoking; (3) ten horrible pictorial warnings of health consequences of smoking and second-hand smoking in one page to maximize the impacts; (4) benefits of SC and (5) simple messages to encourage participants to quit smoking and remind them to call the Department of Health SC hotline 183 3183.
15743924|NCT04909320|Other|Referral card|The contents consist of brief information and highlights of existing SC services, contact methods, motivation information, and strong supporting messages or slogans.
15743925|NCT04909320|Other|Self-help smoking cessation booklet|The contents include information about the benefits of quitting, smoking and diseases, methods to quit, how to handle withdrawal symptoms, declaration of quitting, etc.
15743926|NCT04909320|Behavioral|Positive psychological support through 3-people group chat using instant messaging apps|Each IM chat group will consist of a trained SC counselor (HKU staff), a peer supporter (former smoker), and a participant (smoker). The 3-month group chat-based intervention will consist of regular messages and real-time support through group chat. Regular messages will generally include goal setting, health warnings, abstinence support, positive psychological exercises, and encouragement and will be delivered in a tapering style. During the real-time chatting, SC counsellors and peer supporters will provide real-time chat-based support, and peer supporters will share their quitting experience as appropriate.
15774936|NCT04655391|Drug|Glasdegib Maleate|Given PO
15743928|NCT04909294|Radiation|Stereotactic Radiotherapy with Linac MRI|"38 Gy in 4 fractions of 9.5 Gy over the entire prostate,
~+/- 2 Gy in 4 fractions of 0.5 Gy as an integrated boost on the index tumor if it is visible on diagnostic multiparametric MRI (PIRADS-V2 score 4 or 5) and on planning MRI performed on Linac MRI."
15743929|NCT04909281|Diagnostic Test|Self-sampling HPV|In this cohort study nested in the organized cervical screening program, all women who had not participated in the organized screening program for at least 10 years in one Swedish county were eligible.
15743930|NCT04909268|Diagnostic Test|HIV testing|serology for HIV testing
15743931|NCT04909255|Drug|mirabegron|use beta-3 agonist for sjogren syndrome patient
15743932|NCT04909255|Drug|oxybutynin, tolterodine, solifenacin|use anti-muscarinic agent for patient with overactive bladder syndrome
15743933|NCT04909242|Drug|DZD9008|In the double blind, randomised, placebo-controlled trial (Part A - SAD), healthy adult participants will be randomised to receive DZD9008 at different dose levels. There are 5 planned dose cohorts, starting from 50 mg once daily. If tolerated, subsequent cohorts will test increasing doses of DZD9008 or matching placebo, namely 100 mg, 200 mg, 300 mg and 400 mg.
15743934|NCT04909242|Drug|Placebo|In the double blind, randomised, placebo-controlled trial (Part A - SAD), healthy adult participants will be randomised to receive matching placebo for DZD9008 at different dose levels. There are 5 planned dose cohorts of matching placebo for DZD9008, starting from 50 mg once daily.
15743935|NCT04909229|Device|PEAR-003b PDT Intervention|The PEAR-003b digital therapeutic delivers CBT-I via mobile devices as 6 treatment core modules over 9 weeks.
15743936|NCT04909229|Device|Fitbit|Patients will receive a Fitbit and receive standard of care
15743937|NCT04909229|Behavioral|Sleep education materials|Patients will receive sleep hygiene and healthy sleep tips.
15743938|NCT04909216|Other|Mindful Attention Workshop|The 90-minute workshop will include a 15-minute break and include 5 to 15 participants. The workshop will be led by peer support staff, fire department psychologists, and/or fire department doctoral psychology practicum students. Each workshop will be facilitate by 2-3 workshop leaders. The workshop will provide (1) psychoeducation regarding common mental health concerns among firefighters, (2) introduction to the concept of mindful attention, why it is relevant to firefighters, and how it can prevent or decrease mental health symptoms, (3) 5 experiential mindful attention training exercises, and (4) discussion. Workshop co-leaders will teach 5 mindful attention exercises, and firefighters will practice each exercise and then engage in discussion about their experiences and provide feedback regarding the utility of the exercise for them personally and for firefighters, generally.
15743939|NCT04909203|Device|iKinnect2.0|iKinnect2.0 is a paired mobile phone app for use on both Android and iOS operating systems by youth with conduct disorders and their parents.
15743940|NCT04909203|Device|Active Control App|Mobile phone app for use on both Android and iOS operating systems for GPS tracking of other persons.
15743941|NCT04909190|Procedure|Increased saline flush volume|Additional flushing of the stentgraft delivery system.
15743942|NCT04909177|Other|Smartphone application (app) in combination with headset|The intervention oVRcome is self-help VRET for specific phobia, that is delivered through a smartphone application (app) in combination with headset that holds the smartphone and uses 360º video. oVRcome includes 6 modules of psychoeducation, relaxation, mindfulness, cognitive techniques, exposure through VR, and a relapse prevention module which are aimed to be completed weekly.
15743943|NCT04909164|Drug|Immunnotherapy group|Eligible patients are those who receive reimbursed immunotherapy or cytotoxic chemotherapy after failure of platinum-based chemotherapy per current health insurance reimbursement criteria.
15743944|NCT04909151|Device|Robot-assisted gait training (walking speed: 0.5km/h)|Robot-assisted gait training RAGT, WALKBOT-G, is a walking training equipment that can reproduce natural motions by adjusting the leg length and adjusting the motion with the actuator of the ankle joint.
15743945|NCT04909151|Device|Robot-assisted gait training (walking speed: 0.8km/h)|Robot-assisted gait training RAGT, WALKBOT-G, is a walking training equipment that can reproduce natural motions by adjusting the leg length and adjusting the motion with the actuator of the ankle joint.
15743946|NCT04909151|Device|Robot-assisted gait training (walking speed: 1.1km/h)|Robot-assisted gait training RAGT, WALKBOT-G, is a walking training equipment that can reproduce natural motions by adjusting the leg length and adjusting the motion with the actuator of the ankle joint.
15743947|NCT04909138|Device|DRG stimulation 20 Hz 30/90|Stimulation delivered at 20 Hz and 30 seconds ON, 90 seconds OFF
15743948|NCT04909138|Device|DRG stimulation 5 Hz 30/90|Stimulation delivered at 5 Hz and 30 seconds ON, 90 seconds OFF
15743949|NCT04909125|Radiation|Hypofractionated radiotherapy VS Standard/Conventional fractionation radiotherapy|The purpose of this study is to investigate toxicity following standard conventional fractionation versus moderately hypofractionated radiotherapy to the breast, chest wall and regional lymph nodes
15743950|NCT04909112|Other|Evaluation of olfactory function|Evaluation of olfactory function using olfactory detection thresholds
15743951|NCT04909112|Other|Evaluation of taste function|Evaluation of taste function using taste detection thresholds
15743952|NCT04909112|Other|Evaluation of (intra-nasal and oral) trigeminal functions|Evaluation of (intra-nasal and oral) trigeminal, interacting with olfactory and taste pathways, using odor and taste stimuli.
15743954|NCT04909086|Procedure|Standard physical Therapy|Patients assigned to this group will receive a 40-min multimodal supervised physical therapy treatment comprised of warm-up (10-min cycling/walking), muscle stretching, neuromuscular control exercises, and ten-minute transcutaneous electrical nerve stimulation (TENS). Manual mobilization techniques may be applied as necessary according to the findings of the physical examination. Treating physical therapists will prescribe exercises based on a predetermined list of exercises.
15744024|NCT04908618|Other|closed tray impression|Accuracy of closed tray impression
15743955|NCT04909086|Procedure|Closed Kinetic Chain|Patients assigned to this group will receive a 40-min multimodal supervised physical therapy treatment comprised of warm-up (10-min cycling/walking), three sets of 10 repetitions of 60% of one-repetition maximum (1RM) of seated leg press and partial squat exercises, neuromuscular control exercises, and ten-minute transcutaneous electrical nerve stimulation (TENS). Manual mobilization techniques may be applied as necessary according to the findings of the physical examination. Treating physical therapists will prescribe exercises based on a predetermined list of exercises.
15743956|NCT04909086|Procedure|Open Kinetic Chain|Patients assigned to this group will receive a 40-min multimodal supervised physical therapy treatment comprised of warm-up (10-min cycling/walking), three sets of 10 repetitions of 60% of one-repetition maximum (1RM) of Quadriceps seated strengthening and Hamstring curl-up exercises, neuromuscular control exercises, and ten-minute transcutaneous electrical nerve stimulation (TENS). Manual mobilization techniques may be applied as necessary according to the findings of the physical examination. Treating physical therapists will prescribe exercises based on a predetermined list of exercises.
15743957|NCT04909073|Drug|Afatinib|Continuous treatment of afatinib 30mg tablet once daily in the absence of disease progression or unacceptable treatment-related toxicity, Investigator decision or patient decision to discontinue study treatment.
15743958|NCT04909060|Device|noninvasive blood pressure, 3 lead ECG, peripheral oxygen saturation|Children between 1 and 3 years old, scheduled for elective adeno-tonsillectomy, tonsillectomy or adenoidectomy and with no neurological or cardiac congenital deficits, no cardiac arrythmias (non-sinus rhythm), no implanted pacemakers, nor with a history of prolonged resuscitation at birth, and chronic therapy with drugs that have known effects on sympathetic and parasympathetic activity, ASA physical status III or higher and parent/guardian refusal will have a NIPE placed on their electrocardiogram, at least 20 minutes before the expected end of the surgery, the NIPE monitor will be connected to the anesthesia monitor at the end of the surgery, when the patient is considered ready to be transferred to the PACU, the NIPE will be disconnected and reconnected to the patient monitor once in PACU. Values will be recorded until the patient meets the discharge criteria from PACU not before 2hours
15743959|NCT04909047|Device|parassacral transcutaneous electrostimulation|Use of parassacral transcutaneous electrostimulation
15743960|NCT04909034|Drug|MS-20|Fermented soybean extract MicrSoy-20(MS-20), which uses a variety of lactic acid bacteria and yeasts to metabolize organic soybeans
15743961|NCT04909034|Drug|Placebo|Oral solution without active ingredients
15743962|NCT04909021|Biological|Investigational RSV vaccine MV-012-968 (Dosage 1)|Single dose administered intranasally on Day 1
15743963|NCT04909021|Biological|Investigational RSV vaccine MV-012-968 (Dosage 2)|Single dose administered intranasally on Day 1
15743964|NCT04909021|Biological|Investigational RSV vaccine MV-012-968 (Dosage 3; single-dose)|Single dose administered intranasally on Day 1
15743965|NCT04909021|Biological|Investigational RSV vaccine MV-012-968 (Dosage 3; two-dose)|Single dose administered intranasally on Day 1, followed by an identical dose administered intranasally at the Day 29 study visit
15743966|NCT04909021|Other|Placebo (single-dose)|Single dose administered intranasally on Day 1
15743967|NCT04909021|Other|Placebo (two-dose)|Single dose administered intranasally on Day 1, followed by an identical dose administered intranasally at the Day 29 study visit
15743968|NCT04909008|Other|Exercise Training|10 weeks of supervised exercise training, 3 sessions per week at the cardiac rehab clinic at Mayo Clinic Florida.
15743969|NCT04908995|Drug|EC5026 oral tablet|"12 subjects will receive a single oral 8 mg dose of EC5026 in two Dosing Periods (one in fed state and one in fasted state) separated by a Washout Period. Subjects in this group will be randomized 1:1 to one of 2 sequences:
~Dosing Sequence A: Subjects will be dosed in a fed state in Dosing Period 1 and in a fasted state in Dosing Period 2, or
~Dosing Sequence B: subjects will be dosed in a fasted state in Dosing Period 1 and in a fed state in Dosing Period 2."
15743970|NCT04908995|Other|Placebo oral tablet|"6 subjects will receive an oral dose of matching placebo in one single Dosing Period. Subjects in this group will be randomized 1:1 to receive placebo under fed or fasted conditions.
~Note: Subjects assigned to the placebo arm will not return for a second Dosing Period."
15743971|NCT04908982|Drug|Aspirin 81mg|81mg aspirin daily beginning between 12 and 16 weeks of pregnancy and continuing until delivery.
15743972|NCT04908969|Behavioral|Internet-delivered Cognitive Behavior Therapy for Chronic Tic Dosorder/Tourette Disorder|The treatment will be provided through a secure internet platform designed for internet-administered treatments (BASS-4). In the treatment, the patient works through modules of self-help material, each ending in a short quiz with questions about the material. The treatment is supported by a therapist through text-based communication via the platform as well as occasional phone calls when needed. The central component in the treatment is exposure and response prevention (ERP). In ERP, the patient exposes her/himself to situations that trigger premonitory urges (a type of bodily sensation that precede the tic) while practicing to resist the tic. By doing this systematically and repeatedly, the patient gradually learns how to tolerate the premonitory urges and increase the ability to control and resist doing tics. Beyond ERP the treatment consists of other components such as applied relaxation, counter-movements and interventions to decrease stressors in the patient's everyday life.
15743975|NCT04908943|Behavioral|RENEW|RENEW is a 12-week, peer-led, web-based program to help people with scleroderma learn skills that can be used to manage disease symptoms and improve well-being.
15743976|NCT04908917|Device|Portable Air Cleaner with a HEPA Filter|A novel intervention using a portable air cleaner with HEPA filter to treat mildly high BP to potentially reduce the cardiovascular effects of PM2.5. Leave the PAC running with the HEPA filter installed on the highest setting during sleeping periods in the room in which the participant sleeps.
15743977|NCT04908917|Device|Portable Air Cleaner without a HEPA Filter|Leave the PAC running without a HEPA filter installed on the highest setting during sleeping periods in the room in which the participant sleeps.
15743980|NCT04908891|Other|Clinical Scapular protocol (ClinScaP)|the psychometric properties of two tests: Clinical Scapular protocol (ClinScaP) in PwMS and healthy controls.
15743981|NCT04908891|Other|the prevalence of trunk, scapula and upper limb impairments.|To investigate the prevalence of trunk, scapula and upper limb impairments in PwMS and stroke patients.
15743982|NCT04908891|Other|the interaction between trunk, scapula and upper limb impairments.|To investigate the interaction between trunk, scapula and upper limb impairments in PwMS and stroke patients.
15743983|NCT04908878|Procedure|Pectoral nerve (PECS) block -transversus thoracic plane (TTP) block|Patients will receive unilateral US-guided PECS II block and TTP block on the side of the operation after induction of general anesthesia.
15743984|NCT04908878|Procedure|Serratus anterior plane (SAP) block|Patients will receive US-guided SAP block after induction of general anesthesia.
15743985|NCT04908865|Drug|Belimumab|Belimumab will be administered.
15743986|NCT04908865|Drug|Standard therapy|Standard therapy will be continued.
15743987|NCT04908852|Other|Blood Sample Collection - Observational Study|Blood samples will be collected at enrollment and week 4 and used in analyses to understand associations between metabolic function and symptom experiences.
15743988|NCT04908852|Other|Symptom questionnaires - Observational Study|Symptom questionnaires at baseline, 1-, 2-, 3- and 4-weeks.
15743989|NCT04908839|Other|spot-25 questionnaire|spot-25 questionnaire
15743990|NCT04908826|Procedure|Indocyanine Green (ICG) administration|Patients will undergo laparoscopic cholecystectomy after they are randomly divided into 3 (three) groups. A total of 240 patients will be randomized into three groups of 80. In the first group (A) standard cholangiography will be performed. In group (B) intravenous fluorescent cholangiography with indocyanine green will be performed during surgery. ICG at a dose of 0.3 mg / mL / Kg 6 (six) hours prior to surgery will be administered. In the third group (C), intraoperative cholangiography will be performed with direct administration of indocyanine green at a dose of 0.03 mg / ml / Kg to the gallbladder.
15743991|NCT04908813|Drug|HLX22|IV Q3W D1
15743992|NCT04908813|Drug|Placebo|IV Q3W D1
15743993|NCT04908813|Drug|Trastuzumab|IV Q3W D1
15743994|NCT04908813|Drug|Oxaliplatin|IV Q3W D1
15743995|NCT04908813|Drug|Capecitabine|PO Q3W D1-D14
15743996|NCT04908800|Drug|KRP-A218|KRP-A218 tablet
15743997|NCT04908800|Drug|Placebo|Placebo tablet
15743998|NCT04908800|Drug|itraconazole|10 mg/mL oral solution
15743999|NCT04908787|Drug|BD0801|Subjects receive BD0801 , intravenously, d1, d15, q4w, Dosage form: injectable, Strength: 1.5 mg/kg
15744000|NCT04908787|Drug|Paclitaxel|Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, d22, q4w, Dosage form: injectable, Strength: 80 mg/m2
15744001|NCT04908787|Drug|Placebo|Subjects receive Placebo, intravenously, d1, d15, q4w, Dosage form: injectable, Strength: 1.5 mg/kg
15744002|NCT04908787|Drug|Topotecan|Subjects receive Topotecan, intravenously, d1, d8, d15, q4w, Dosage form: injectable, Strength: 4mg/m2
15744003|NCT04908787|Drug|doxorubicin liposome|Subjects receive doxorubicin liposome, intravenously, d1, , q4w, Dosage form: injectable, Strength: 40mg/m2
15744004|NCT04908774|Behavioral|Fasting Mimicking Diet|"The mobile application Salufast provides standardised fasting packages for 5 days of approx. 500 kcal and accompanies the participants during all fasting days."
15744005|NCT04908761|Procedure|Transmuscular quadratus lumborum block|Patients assigned to the TQL block group receive the TQL block in a supine position with the surgical site facing up before recovery of general anesthesia after surgery. For the block, 30cc of 0.375% ropivacaine is used.
15744006|NCT04908761|Procedure|Placebo|For patients assigned to the control group, 30cc of 0.9% normal saline is used for TQL block.
15744007|NCT04908748|Drug|Esflurbiprofen Hydrogel Patch|Esflurbiprofen is a cyclooxygenase (COX) inhibitor indicated for the treatment of osteoarthritis pain and inflammation
15744008|NCT04908735|Drug|Ruxolitinib|Participants will receive ruxolitinib orally twice daily for 24 weeks.
15744010|NCT04908709|Procedure|Magnetic Resonance Spectroscopic Imaging|Undergo sMRI
15744011|NCT04908709|Device|Proton Therapy|Target volume treatment
15744012|NCT04908696|Procedure|routines|"For early stage laryngeal carcinoma and hypohparyngeal carcinoma (T1 and T2), transoral laser microsurgery (CO2 laser resection), open partial laryngectomy (vertical partial laryngectomy, cricohyoidoepiglottopexy, cricohyoidopexy, horizontal partial laryngectomy), partial hypopharyngectomy, radiotherapy, and transoral robotic surgery were performed for patients with proper indications (NCCN 2020).
~For advanced stage laryngeal carcinoma and hypohparyngeal carcinoma (T3 and T4), surgical treatment ± postoperative adjuvant therapy, concurrent chemoradiotherapy, neoadjuvant therapy + radiotherapy/chemoradiotherapy, or neoadjuvant therapy + surgery + radiotherapy or chemoradiotherapy were performed for patients with proper indications (NCCN 2020)."
15744015|NCT04908670|Behavioral|Understanding Pain in less than 5 minutes, and what to do about it! https://www.youtube.com/watch?v=C_3phB93rvI|Watching pain neuroscience education video
15744016|NCT04908670|Procedure|PA manipulation|Low grade PA manipulation on the cervical, thoracic and lumbar spine
15744017|NCT04908657|Drug|Sildenafil 20 MG|oral sildenafil 20 mg three times per day for 3 years
15744018|NCT04908644|Drug|MS-20 oral solution|Fermented soybean extract MicrSoy-20(MS-20), which uses a variety of lactic acid bacteria and yeasts to metabolize organic soybeans
15744019|NCT04908644|Other|Placebo|Placebo
15744022|NCT04908618|Other|digital impression for normal abutment|Accuracy of scan body impression
15744023|NCT04908618|Other|open tray impression|Accuracy of open tray impression
15744026|NCT04908605|Drug|Melatonin|Every patient will be given melatonin 5 mg tablet
15744027|NCT04908605|Drug|Placebo|Every patient will be given a matching placebo tablet
15744030|NCT04908579|Drug|bupivacaine(intraperitoneally) and ketamine (intraperitoneally)|"40 ml volume of bupivacaine 0.25% + ketamine 0.5 mg/kg distributed as 30 ml intraperitoneally and 10 ml as port site infiltration
~10 ml normal saline 0.9% will be given intravenous."
15744031|NCT04908579|Drug|bupivacaine(intraperitoneally) and ketamine (intravenously)|"40 ml volume of bupivacaine 0.25% only distributed as 30 ml intraperitoneally and 10 ml as port site infiltration
~10 ml volume of ketamine 0.5 mg/kg intravenously will be given after delivering the gastric sleeve and before start closure of port sites."
15744032|NCT04908579|Drug|bupivacaine(intraperitoneally)|"40 ml volume of bupivacaine 0.25% only distributed as 30 ml intraperitoneally and 10 ml as port site infiltration
~10 ml normal saline 0.9% will be given intravenous."
15744033|NCT04908566|Drug|PD-1 antibody combined with FOLFIRINOX regimen|Give 240 mg of PD-1 antibody before each cycle of chemotherapy, d1; Chemotherapy regimen: irinotecan 150mg/m2, d1; fluorouracil 2400 mg/m², d1-2, continuous pumping for 46 hours; leucovorin 200 mg/m², d1; oxaliplatin 65 mg/m², d1; PD-1 antibody repeats once every 3 weeks; Chemotherapy is repeated every 2 weeks. 4 cycles before surgery. 4 cycles after operation。
15744034|NCT04908566|Drug|PD-1 antibody combined with SOX program|"Give 240 mg of PD-1 antibody before each cycle of chemotherapy, d1; Chemotherapy regimen: oxaliplatin 130 mg/m², d1, ticgio 40-60mg bid, d1-14 q3w;Repeat once every 3 weeks.
~2-4 cycles before surgery. The perioperative period was 8 cycles."
15744035|NCT04908553|Drug|Remimazolam Tosilate for Injection 0.1mg/kg|Remimazolam Tosilate for Injection 0.1mg/kg at induction
15744036|NCT04908553|Drug|Remimazolam Tosilate for Injection 0.15mg/kg|Remimazolam Tosilate for Injection 0.15mg/kg at induction
15744037|NCT04908553|Drug|Remimazolam Tosilate for Injection 0.2mg/kg|Remimazolam Tosilate for Injection 0.2mg/kg at induction
15744038|NCT04908540|Procedure|Mini-screw Assissted Rapid Palatal Expansion|Mini-screw assissted RPE will be the main intervention in the two comparative groups. In the control (group A) will be used with its conventional activation protocol. While in experimental (group B) will be used with ALT-RAMEC protocol.
15744039|NCT04908527|Behavioral|Walking to OR|Patients, after being prepared for the OR, walk to the operating room
15744040|NCT04908514|Drug|ADX-629|ADX-629 administered orally twice daily (BID) for approximately 12 weeks.
15744041|NCT04908501|Other|Intervention|The program intervention has three focuses : the prioritization of appropriateness indicators, the automation and visualization of the prioritized indicators, and support for practice analysis groups (PAG) based on e-feedback from automated indicators
15744042|NCT04908488|Device|Verofilcon A toric contact lenses|Soft contact lenses for optical correction of astigmatism
15744043|NCT04908488|Device|Etafilcon A toric contact lenses|Soft contact lenses for optical correction of astigmatism
15744046|NCT04908462|Drug|AL01211 or Placebo (Part A)|Five dose groups with doses ranging from 2mg to 60 mg
15744047|NCT04908462|Drug|AL01211 or Placebo (Part B)|Five dose groups with doses ranging from 2-60 mg daily. Each separate dose given for 14 days
15744048|NCT04908462|Drug|AL01211 or Placebo (Part C)|Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) will be treated once daily for 28 days
15744049|NCT04908449|Drug|Serratus anterior plane block with bupivacaine|Serratus anterior plane block with local anesthetic versus sham block with saline
15744050|NCT04908436|Drug|Finerenone (BAY94-8862)|10 mg BAY94-8862 immediate release (IR) tablet, administered orally
15744051|NCT04908423|Drug|Xeomin®|To discover whether injection into the upper extremity with Xeomin® triggers improvements in gait-related mobility and quality of life in adults with hemiparesis secondary to stroke.
15744052|NCT04908397|Dietary Supplement|L-carnitine|supplement provided twice a day for 2 weeks
15744053|NCT04908384|Behavioral|Improving Asthma Care Together (IMPACT)|IMPACT is a novel health application and wearable device
15744054|NCT04908371|Procedure|Selective Trunk Block|"It is one type of peripheral nerve blocks for upper extremity surgery. Patients will have an ultrasound scan and nerve block with local anesthetic (LA) agent (a mixture of 2% Xylocaine with 1:200,000 adrenaline and 0.5% Chirocaine in a total of 20ml) injected at the trunks of the brachial plexus in order to produce the anesthesia of the whole upper extremity of the patients scheduled for upper limb surgery. SeTB will be performed as a two-injection technique. One at the side of the neck (interscalene groove) of the affected upper limb, injections will be made near the superior trunk (5mL) and follow by redirection of the needle under ultrasound guidance to inject the LA to middle trunk (5mL). Then the second skin puncture will be made near the upper part mid-collar bone (supraclavicular fossa) to inject the LA to the inferior trunk (10mL)."
15744055|NCT04908371|Procedure|Interscalene-Supraclavicular Brachial Plexus Block (IS-SC BPB)|"It is another type of peripheral nerve blocks for upper extremity surgery. Patients will have an ultrasound scan and nerve block with local anesthetic (LA) agent (a mixture of 2% Xylocaine with 1:200,000 adrenaline and 0.5% Chirocaine in a total of 30ml) injected at the interscalene groove and supraclavicular fossa, so two-injection technique will be adopted. The first skin puncture will be near the side of the neck (interscalene groove) of the affected upper limb (15mL) and then the second skin puncture will also be made near the upper mid-collar bone (supraclavicular fossa) to inject 15mL of LA."
15744056|NCT04908358|Other|Active transcutaneous vagus nerve stimulation respiratory-gated non-painful electrical stimulation of the auricle for 10 minute sessions|Stimulation of vagus nerve in the outer ear
15744057|NCT04908358|Other|Sham transcutaneous vagus nerve stimulation respiratory-gated non-painful electrical stimulation of the auricle for 10 minute sessions|Sham stimulation of vagus nerve in the outer ear
15744058|NCT04908345|Drug|Methadone|Used at induction and during surgery
15744059|NCT04908345|Drug|Fentanyl|Used at induction and during surgery
15744240|NCT04906876|Drug|9-ING-41|9-ING-41 as an IV infusion over 1-4 hours twice weekly
15744060|NCT04908332|Behavioral|Kangaroo Baby Massage|The Kangaroo Baby Massage is an intervention that arose from nursing practice in 1996. It is a therapy that does not require an incubator, fuses massage, kangaroo position and music. KBM is available on video
15744063|NCT04908280|Drug|Ruxolitinib|1.5% cream; Ruxolitinib cream will be applied topically twice daily to areas with active lesions.
15744064|NCT04908254|Device|Crossover Device (PCD or Dayspring - alternate to first group)|Cross over arms after a month of use and a month of washout period
15744065|NCT04908241|Other|TRAIL|"Each week has a specific focus for lower extremity rehabilitation:
~Week 1) Building a base: 8 exercises, 10-15 repetitions x 2-3 sets
~Week 2) Increasing repetitions: 8 exercises, 15-20 repetitions x 3 sets
~Week 3) Building exercise tolerance:10 exercises, 15-20 repetitions x 3 sets
~Week 4) Maximizing repetitions: 10 exercises, 30 seconds as many reps as possible x 2 sets
~At the end of the second exercise session each week, the therapist and participants work collaboratively to develop an independent exercise action plan to be completed before the first session of the next week. The self-managed plans includes exercises selected from TRAIL, agreed upon by the participant and therapist, that are safe to perform without therapist oversight. The aims of the exercise action plan are to: i) Add exercise volume without using program resources (e.g., therapist time); and ii) Build capacity for self-management for long-term health and well-being after TRAIL has ended."
15744066|NCT04908241|Other|EDUCATION|"EDUCATION has a specific focus on:
~Week 1) What is stroke (e.g., gaining an understanding of the function of the brain, types of stroke and how stroke affects physical function) and introduction to self-management;
~Week 2) What is self-management;
~Week 3) Self-management for post-stroke complications (e.g., activities of daily living);
~Week 4) Self-management for secondary prevention (e.g., blood pressure, diet, medication, stress management).
~Education therapists will be provided with lesson plans and manuals to be circulated with the participants, and will facilitate the educational session through interactive Powerpoint presentations. In addition, participants will be asked to complete 30-60 minutes of educational homework, which will be discussed at the commencement of the following session."
15744067|NCT04908228|Drug|Ibrutinib and obinutuzumab|Patients will receive fixed-duration treatment with ibrutinib and obinutuzumab.
15744068|NCT04908215|Drug|INM-755 (cannabinol) cream|topical cream containing cannabinol for dermal application
15744069|NCT04908215|Drug|Vehicle Cream|topical cream base for dermal application containing no active agent
15744070|NCT04908202|Drug|Deucravacitinib|Specified dose on specified days
15744071|NCT04908202|Other|Placebo|Specified dose on specified days
15744075|NCT04908176|Drug|Avapritinib|avapritinib tablets
15744076|NCT04908176|Drug|midazolam|midazolam syrup
15744077|NCT04908163|Behavioral|Mediterranean diet-based nutritional education intervention|The patients in the nutritional intervention group will receive dietary advice on how to follow a Mediterranean diet. The dietary recommendations will be given at the beginning of the study by nutritionists using comprehensive written material.
15744078|NCT04908163|Behavioral|Mediterranean diet-based culinary intervention|The culinary intervention will be developed integrating eight culinary and nutritional workshops that will be given every week, twice per week, during one-month intervention. The duration of each culinary and nutritional workshop will be 1 hour, thus, the program will provide a total of hours of nutritional education and a total of 8 hours of nutritional and cooking training. The courses will take place in a well-equipped kitchen from the Basque Culinary Center and participants will be connected online in order to be able to cook and practice at the same time. All cooking classes will begin with a theoretical introductory part that aim to explain the main take-home messages from the workshop. Subsequently, every class will be characterized by a hands-on part that will include the demonstration and practical preparation of different elaborations based on the use specific cooking techniques and healthy ingredients.
15744079|NCT04908150|Other|Core training|A total of 12 sessions were carried out, which lasted for 4 weeks, with a frequency of 3 sessions/ week. The duration of each session was 11 minutes 30 seconds. The working time of each exercise was 30 seconds with a 5 seconds rest between exercises, meaning that each exercise cycle lasted for 2.50 seconds. Three exercise cycles were performed with a 90 seconds rest between each one of them
15744080|NCT04908137|Drug|2-octyl cyanoacrylate|Topical Skin Adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet No. 2. It is provided as a single use applicator in a blister package
15744081|NCT04908124|Device|Lubricant A|Water-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application.
15744082|NCT04908124|Device|Lubricant B|Water-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application.
15744083|NCT04908124|Device|Lubricant C|Water-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application.
15744084|NCT04908124|Device|Lubricant D|Water-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application.
15744085|NCT04908124|Device|Lubricant E|Water-based lubricant, which is suitable for oral, anal and vaginal sexual intercourse. Approximately 3g of lubricant will be considered a single application.
15744099|NCT04908007|Other|Tools development|"Development of tools to prepare for situations of uncertainty : In the third phase of the project, design thinking workshops will be organized (within the HCL) to develop training (in the form of simulation) in order to appropriate virtuous practices in situations of uncertainty. The purpose of these training sessions will be to improve the institution's ability to learn in a situation of uncertainty and thus to develop its reliability.
~The aim of these workshops is to provide tools for raising awareness of situations of uncertainty to all hospital staff."
15744100|NCT04907994|Other|Cohort|Nothing. Only implementation of a cohort with data collection via the SNDS.
15744101|NCT04907981|Diagnostic Test|Novel coronavirus infection|Using eye examination to judge whether novel coronavirus is infected or not.
15744086|NCT04908111|Biological|ChAdOx1-MAGEA3-NYESO|"Patients will commence their standard of care chemotherapy in combination with an immune checkpoint inhibitor in three weekly cycles. Patients will be screened during the first two cycles of standard of care treatment to confirm whether they are eligible to take part in the trial.
~Patients who are to receive the trial vaccines (in the safety run in stage and in Arm A of the NSCLC randomisation cohort) will continue to receive their standard of care treatment plus:
~First prime ChAdOx1-MAGEA3-NYESO vaccine on Cycle 3 Day 1 of standard of care treatment.
~First boost MVA-MAGEA3 vaccine 21 days later.
~Only for patients who have not progressed: Second prime ChAdOx1-MAGEA3-NYESO vaccine 15 week following the first prime vaccine.
~Second boost MVA-MAGEA3 vaccine 21 days following the second prime vaccine.
~Patients in Arm B will continue to receive their standard of care treatment only throughout the trial (i.e. no trial vaccines)."
15744087|NCT04908111|Biological|MVA-MAGEA3|"Patients will commence their standard of care chemotherapy in combination with an immune checkpoint inhibitor in three weekly cycles. Patients will be screened during the first two cycles of standard of care treatment to confirm whether they are eligible to take part in the trial.
~Patients who are to receive the trial vaccines (in the safety run in stage and in Arm A of the NSCLC randomisation cohort) will continue to receive their standard of care treatment plus:
~First prime ChAdOx1-MAGEA3-NYESO vaccine on Cycle 3 Day 1 of standard of care treatment.
~First boost MVA-MAGEA3 vaccine 21 days later.
~Only for patients who have not progressed: Second prime ChAdOx1-MAGEA3-NYESO vaccine 15 week following the first prime vaccine.
~Second boost MVA-MAGEA3 vaccine 21 days following the second prime vaccine.
~Patients in Arm B will continue to receive their standard of care treatment only throughout the trial (i.e. no trial vaccines)."
15744088|NCT04908111|Combination Product|Standard of care treatment|Patients will continue to receive standard of care treatment (chemotherapy and checkpoint inhibitor).
15744089|NCT04908098|Device|diode laser|It is the application of the laser tip parallel to the inner surface of the periodontal pocket
15744090|NCT04908098|Procedure|scaling - root planning|Scaling is the removal of calculus and other deposits in the root of the tooth.Root planning is the removal of necrotic cementum on the tooth root surface. Scaler and gracey curettes are used for these operations.
15744091|NCT04908085|Behavioral|Occupational Performance Coaching|Six sessions of OPC delivered by telephone over 10 weeks.
15744092|NCT04908072|Device|Orbis-FundamentalVR MSICS Simulator|Cataract surgery training device, using virtual reality software combined with existing gaming technology for simulated surgery
15744093|NCT04908046|Drug|HMPL-295S1 with dose escalation stage of 5mg up to 200mg, then expansion stage with recommended dose of therapeutic cycle of 28 days .|"Patient starts the initial dose treatment with 5mg QD of HMPL-295S1, during dose escalation, single-dose PK evaluation will be carried out firstly in each dose group.
~At the first therapeutic dose level, the single-dose treatment period is 5 days; from the 2nd dose level, the sponsor can determine the adjustment of single-dose treatment period to 3-5 days based on the available PK profile.
~Subsequently, the patients will receive oral HMPL-295S1 QD continuously in a therapeutic cycle of 28 days (Day 1 - 28 of each cycle), until reaching the criteria on the end of treatment. The patients in RP2D extended cohort will enter the consecutive treatment period directly."
15744094|NCT04908033|Device|pacemaker implantation|pacemaker implantation
15744095|NCT04908020|Other|Follow-up patients|The intervention consists in the assessment of some psychological aspects (post traumatic stress symptoms and coping) of cancer patients in follow-up care, through specific tests. Each patient fills out the test battery during the psychological consult. At the same time, it is involved a parent to collect personal and clinical data through an ad hoc questionnaire.
15744096|NCT04908007|Other|Qualitative analysis for professionals|"3 individual interviews with the different categories of professionals most involved during the crisis in each university hospital. In the first phase, the points of improvement identified will be analyzed In the second phase, good practices and innovations will be analyzed. For these first two phases, the duration of one hour was chosen because it is difficult to mobilize the professionals for longer. Individual interviews are preferred, but group interviews are possible with no more than three people so that everyone can express himself or herself. Finally, individual interviews of 15 to 30 minutes will be conducted with some of the people interviewed previously in order to identify the costs of the dysfunctions or problems encountered during the crisis.
~Questionnaires with establishments associated with the crisis management, the ARS AuRA and France Assos Santé AuRA.
~Analysis of evidence documents in the university hospitals"
15744097|NCT04908007|Other|Quantitative analysis for Professionals|"A self-assessment of the three phases of the crisis management process (preparation, crisis management, crisis recovery) will be carried out in the participating establishments using the WHO grid with the target persons identified within the establishments.
~This step will use the crisis response assessment tool developed by the WHO following the H1N1 pandemic in 2011. This grid will be adapted beforehand to the COVID-19 situation and to the local organization by the study's scientific committee. The dimensions investigated will be : Command and control, Communication, Safety and security, Triage, Surge capacity, Continuity of essential services; Human resources, Logistics and supply management, Post-disaster recovery.
~The grids will be sent to the 4 university hospitals to be filled in with the target audience recommended by the WHO methodological guide.
~The results of this self-assessment will be linked to and interpreted with the results of the interviews in phase 1."
15744098|NCT04908007|Other|Quantitative analysis for Patients|"A questionnaire of patients' perceptions on the same perimeter (crisis and post-crisis management, from the point of view of points of improvement and good practices) will be constructed and sent by the management of the establishments to all patients hospitalized for 48 hours or more during the first wave and who have left their email address (methods similar to the e-satis survey). The online questionnaire survey is preferred in order to get away from the emotion and for feasibility reasons. This patient experience questionnaire adapted to COVID will be co-constructed with expert/partner patients and user associations.
~Four dimensions will be investigated : The perception of the quality of the information received by the patient, The nature of the information on the specific health protection protocol from which the patient benefited, The patient's consideration of the overall context, during and after, The effects of the health context on the overall management of the patient"
15744104|NCT04907955|Procedure|phacoemulsification with implantation of presbyopia correcting IOL|cataract extraction with phacoemulsification and insertion of presbyopia correcting IOL
15744105|NCT04907942|Device|EMA + Automated Text Message Intervention|Intervention includes 3 weeks of EMA (2 daily surveys per day delivered during waking hours to evaluate momentary affects) plus 2 weeks of automated text messages delivered twice a day, which content follows constructs from The Transactional Model of Stress and Coping.
15744106|NCT04907942|Behavioral|EMA Alone|Three weeks of EMA consisting of 2 daily surveys per day delivered during waking hours to evaluate momentary affects.
15744107|NCT04907929|Behavioral|targeted speech and cognitive therapy|One month of targeted speech and cognitive therapy with a speech therapist and with home exercice at home by using a numeric solution
15744108|NCT04907916|Other|SIRTUIN1|The NAD dependent deacetylase activity of Sirtuin1
15744109|NCT04907903|Other|internet-based intervention|Intervention consists in 8 weekly online cognitive-behavioral modules (for a total duration of 2 months).
15744110|NCT04907877|Other|Dietary Supplement|Probiotic/Placebo will be taken 1 time a day before breakfast for 30 days. In the case of the secondary disease, it will be continued for 28 days.
15744111|NCT04907864|Combination Product|Multi-modal intervention|Daily oral medications: ibuprofen 400 mg three times a day, omega-3-fatty acid 1 g twice a day, Bojungikki-tang 3.75g twice a day, oral nutritional supplement (HAMONILAN SOLN) 200 ml twice a day Weekly physical exercise by physiatrist (60 minutes per visit) Biweekly psychiatric intervention Nutritional counselling total four times during the study period
15744112|NCT04907851|Drug|RXC004|RXC004 will be administered orally, 2 mg QD Dose Formulation: 0.5 mg or 1 mg capsules.
15744113|NCT04907851|Biological|Denosumab|Denosumab will be administered via subcutaneous (SC) injection, 120 mg once every month. Use: Prophylactic
15744114|NCT04907838|Drug|Insulin clamp|Continous infusion insulin + glucose
15744115|NCT04907838|Drug|BQ123|Continuous infusion of Insulin + glucose + BQ123
15744116|NCT04907838|Drug|BQ123 + BQ788|Continous infusion of insulin + glucose + BQ123 + BQ788
15744117|NCT04907825|Drug|Oral anticoagulant|Anticoagulant therapy will be initiated/titrated in patients with atrial fibrillation in accordance with ACC/AHA/HRS Guidelines
15744118|NCT04907812|Drug|Tranexamic acid|Patients will receive 1 gram dose of intravenous (IV) tranexamic acid mixed with 50cc 0.9% sodium chloride before your surgery and 1 gram dose of intravenous (IV) tranexamic acid mixed with 50cc 0.9% sodium chloride 3-6 hours after your first dose on the day of your surgery
15744119|NCT04907812|Procedure|Surgery|This will include regional anaesthesia, tourniquet inflation to 250mmHg and perioperative antibiotics. At the conclusion of the procedure hemostasis will be achieved followed by standard closure technique. There will be three separate surgical groups that will undergo the outlined study protocol: 1) Distal radius fractures will be treated with open reduction from a volar approach only technique 2) Mild dupuytren's: a. Low: i. MCP joints <50 contracture ii. PIP joints <40 contracture b. 1-2 fingers involved 3) Severe dupuytren's a. High: i. MCP joints >50 degree contracture ii. PIP Joints >40 degrees contracture b. >2 fingers involved
15744120|NCT04907799|Behavioral|Daily caloric restriction|Weight loss based on daily caloric restriction and increased physical activity
15744121|NCT04907799|Other|Standard advice control|Initial nutrition consultation without subsequent counseling
15744122|NCT04907773|Other|Capillary blood sampling|Each subject will have one to two capillary blood collections.
15744123|NCT04907773|Other|Venous blood sampling|Each healthy subject will also have a reference venous blood collection.
15744124|NCT04907773|Other|Arterio-venous blood sampling|Each hemodialysed subject will also have a reference arterio-venous blood collection.
15744125|NCT04907760|Other|Personalized care program|It includes the participant follow-up by a nurse during 5 years with a contact every 4 months for the first year, then after every 6 months
15744126|NCT04907747|Drug|Vonoprazan|Potassium-competitive acid blocker
15744127|NCT04907747|Drug|Esomeprazole|Proton pump inhibitor
15744128|NCT04907747|Drug|Colloidal bismuth pectin|Gastric mucosal protective drug with anti-H. pylori effect
15744129|NCT04907747|Drug|Amoxicillin|Antibiotic for H. pylori eradication
15744130|NCT04907747|Drug|Furazolidone|Antibiotic for H. pylori eradication
15744131|NCT04907734|Other|Caliper|Description of the sample adipose tissue and skinfolds using different calipers.
15744132|NCT04907721|Diagnostic Test|Glucagon Sensitivity test consisting of an amino acid tolerance test and a bolus infusion of glucagon|"The test consists of two experimental trial days:
~Day 1 includes an intravenous (iv) bolus-infusion of glucagon (2 mg) and thereby evaluates the effect of exogenous glucagon on amino acid disappearance. Two blood samples will be obtained at time -10 minutes and 0 minutes following an overnight fast. Immediately after the blood sample at time 0 minutes, a bolus infusion will be administered iv. Blood samples will be obtained until time 120 minutes and a maximum of 100ml blood will be sampled.
~Day 2 includes a 45-min iv infusion of mixed AAs (331 mg/min/kg body weight) to evaluate the liver-alpha cell axis (sensitivity of endogenous glucagon signaling). Two blood samples will be obtained at time -10 minutes and 0 minutes following an overnight fast. Immediately after the blood sample at time 0 minutes, the amino acid infusion will start and continuously be infusion until time 45 minutes. Blood samples will be obtained until time 180 minutes and a maximum of 200ml blood will be sampled."
15744133|NCT04907708|Drug|Metformin|Euglycemic agent
15744134|NCT04907708|Drug|Insulin|Hypoglycemic agent
15744135|NCT04907695|Device|I View Video Laryngoscope https://www.intersurgical.com/content/files/108253/-1977057700|All intubations will be performed at the direction of the attending clinician. The decision to intubate is based purely on clinical factors by the primary team. The decision to use VL device will be at the direction of the clinical team. No patient will be recruited specific for this procedure.
15744136|NCT04907682|Drug|Ribavirin iv|100 mg/kg Day 1 (dose is divided: 2/3 stat, 1/3 8 hours later, maximum dose is 7g/day), then 25 mg/kg days 2-7, 12.5 mg/kg days 8-10
15744137|NCT04907682|Drug|Favipiravir|Day 1 2400mg(H0)-2400mg(H8)-1200mg(H16), Day 2-10 1200mg twice daily
15744201|NCT04907162|Diagnostic Test|Vital signs|Vital signs (blood pressure, heart rate, respiratory rate) will be measured before and after the six-Minute-Walk-Test (6MWT).
15744241|NCT04906863|Genetic|Blood draw|Blood draw for identification of genetic variants associated with the development of memory problems
15744242|NCT04906863|Other|Neurocognitive testing|Brief memory test
15744138|NCT04907669|Other|Brief contact intervention|"The BCI in this study is a series of structured messages, and messages will be delivered to participants by pushing feeds through WeChat and an iOS/Android application developed for this study. If participants did not use smartphones, messages will be delivered by mobile text messages or by phone calls. Though the final details are yet to be determined by the CBPR study, the investigators expect to structure messages into six components including introduction, greetings for previous complains, mental health promotion, encouragement, and coping strategies, remind of treatment and subsequent visit, and crisis intervention resource.
~Noted, the same messages will also be sent to patients' LHSs."
15744139|NCT04907656|Behavioral|dCBT|As per arm of the same name
15744140|NCT04907643|Device|PICO G2 4k|Participants will use the Pico G2 4K VR audio and visual head-mounted device. The Pico G2 4K is a standalone VR headset that comes with an orientation-tracked controller. It does not require a smartphone or personal computer to operate. The device supports 3 degrees of freedom (3DOF) head tracking, has best-in-class optics, and a wide field-of-view.
15744141|NCT04907630|Behavioral|Antenatal Education|educational intervention
15744142|NCT04907617|Other|FAW|After the induction of anaesthesia, for patients assigned to groups 1 and 3, the cover of the forced-air warming device (Bair HuggerTM Warming Unit, Model 505, Augustine Medical Inc., Eden Prairie, MN, USA) will be covered over the patient, with the surgical site exposed, and the temperature adjustment of the device will be set to the maximum (43°C). Then, the temperature will be adjusted to maintain a patient temperature of at least 36.5°C. When the patient's body temperature reaches 37°C, the device will be turned off and it will be restarted at a temperature measurement of <36.5°C.
15744143|NCT04907617|Other|Warmed fluids|In patients assigned to groups 2 and 3, intraoperative IV (Automer blood/fluid warming system, Acemedikal, South Korea) and irrigation fluids (Enthermic Warming Cabinet 1002W, Poland) will be given by heating to 37°C in a thermostatically controlled heating cabinet.
15744144|NCT04907617|Other|Combination|"After the induction of anaesthesia, for patients assigned to groups 3, the cover of the forced-air warming device (Bair HuggerTM Warming Unit, Model 505, Augustine Medical Inc., Eden Prairie, MN, USA) will be covered over the patient, with the surgical site exposed, and the temperature adjustment of the device will be set to the maximum (43°C). Then, the temperature will be adjusted to maintain a patient temperature of at least 36.5°C. When the patient's body temperature reaches 37°C, the device will be turned off and it will be restarted at a temperature measurement of <36.5°C.
~In patients assigned to groups 3, intraoperative IV (Automer blood/fluid warming system, Acemedikal, South Korea) and irrigation fluids (Enthermic Warming Cabinet 1002W, Poland) will be given by heating to 37°C in a thermostatically controlled heating cabinet."
15744145|NCT04907617|Other|Control|The patients assigned to group 4 will only receive 'routine care'. They will not be given intraoperative forced-air warming or heated IV and irrigation fluids.
15744146|NCT04907604|Device|A multi-modal and integrative e-health platform aimed at promoting health and reducing the negative impact of mental problems in the workplace|It addresses six main domains: improving awareness of mental health problems and reducing stigma; reducing psychosocial risk factors in the workplace; improving wellbeing and reducing psychological symptoms; ensuring early detection of mental disorders; promoting healthy behaviours and lifestyles; and facilitating early return to work.
15744147|NCT04907591|Device|mHealth App and wearable device|an intervention group (App+IoT device) uses a smart care application tailored to gastric cancer patients created by reflecting the treatment process immediately after surgery and a wearable smart band worn on wrist for 12 months.
15744148|NCT04907565|Biological|Blood sampling|4 tubes of 7 mL of blood will be collected
15744149|NCT04907565|Biological|white adipose tissue sampling|At the beginning of the surgery, samples of white adipose tissue from the surgical wound will be collected.
15744150|NCT04907539|Drug|RXC004|"RXC004 will be administered orally, 1.5 mg QD
~Dose Formulation: 0.5 mg or 1 mg capsules."
15744151|NCT04907539|Biological|Nivolumab|Nivolumab will be administered via IV infusion, 480 mg q4w.
15744152|NCT04907539|Biological|Denosumab|"Denosumab will be administered via subcutaneous (SC) injection, 120 mg once every month.
~Use: Prophylactic"
15744153|NCT04907526|Biological|Autologous mononuclear cells|Autologous mononuclear cells delivered into right ventricle at time of Stage III Fontan surgery.
15744154|NCT04907513|Other|Assessment of the Motivational State|A motivational interviewing algorithm developed in Rothschild Hospital for this study will be used. The results range between 0% (worst motivational state) to 100% (best motivational state).
15744155|NCT04907500|Device|Intraocular lens|Cataract surgery
15744156|NCT04907487|Device|MRI|"MRI of routine care includes at least the following sequences:
~3D T1 TFE (2 minutes)
~T2 TSE (2 minutes)
~3D FLAIR (3 minutes)
~The sequences added by the research lasting 25 minutes are:
~SWI QSM 1.0iso 8 echoes (10 minutes)
~SWI QSM 1.0iso 8 echoes CS 6 (7 minutes)
~SWI QSM 1.0iso 8 echoes CS 9 (5 minutes)
~SWI QSM 1.0iso 8 echoes CS 12 (3 minutes)"
15744157|NCT04907474|Drug|tropicamide-phenylephrine fixed combination ophthalmic solution|Tropicamide-phenylephrine fixed combination ophthalmic solution is a tropical drug solution for mydriasis
15744158|NCT04907461|Procedure|LAPTAP|Laparoscopic guided Transverse Abdominus Plane block
15744159|NCT04907448|Other|Physical Therapy|"The IsoK-ST group received their usual physical therapy program for 45 minutes, three times a week for eight successive weeks, which comprised advanced balance training, weight-bearing exercises, gait training, postural and flexibility exercises, and strength training exercises.
~Additionally, the IsoK-ST group received an IsoK-ST program, thrice/week for eight successive weeks.
~The control group received the usual physical rehabilitation program only for 45 minutes, three times a week for eight successive weeks."
15744160|NCT04907435|Procedure|simultaneous operations|simultaneous operations
15744161|NCT04907422|Diagnostic Test|CD24-Gold Nanocomposite expression using Real-time quantitative polymerase chain reaction|new strategy where gold nanoparticles synthetized and added to CD24 primer forming CD24-Gold Nanocomposite to be used for detection of cancer stem cells
15744162|NCT04907422|Diagnostic Test|non-conjugated CD24 expression using Real-time quantitative polymerase chain reaction|conventional strategy using non-conjugated CD24 expression to used for detection of cancer stem cells
15744163|NCT04907383|Other|quality of life|QoL assessment
15744237|NCT04906889|Drug|Lidocaine Hydrochloride|lidocaine iv bolus followed by the infusion of 1.5mg/kg/h during general anesthesia
15744238|NCT04906876|Drug|Gemcitabine|Gemcitabine as a 90-minute IV infusion
15744164|NCT04907370|Drug|PD-1 blocking antibody|"IC phase of PD-1 blocking antibody: every 3 weeks × 3 cycles; 240 mg, day 1; start on day 1 of the first cycle IC and continue every 3 weeks for 3 cycles till the end of IC.
~IMRT phase of PD-1 blocking antibody: every 3 weeks × 3 cycles; 240 mg, day 1; start on day 1 of IMRT or CCRT and continue every 3 weeks for 3 cycles till the end of IMRT.
~Adjuvant PD-1 blocking antibody: every 3 weeks × 11 cycles; 240 mg, day 1"
15744165|NCT04907370|Drug|Gemcitabine|Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 3 cycles
15744166|NCT04907370|Drug|Cisplatin (80mg/m2)|Cisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles
15744167|NCT04907370|Drug|Cisplatin (100mg/m2)|Cisplatin as concurrent chemotherapy, 100 mg/m2 day 1 per cycle, every 3 weeks for 2 cycles
15744168|NCT04907370|Radiation|Intensity-modulated radiotherapy|Definitive IMRT of 70 Gy, 33 fractions, 5 fractions/week, 1 fraction/day
15744169|NCT04907357|Device|rTMS|Each rTMS session will consist of 75 rTMS trains of 10 Hz for 4 seconds (40 pulses per train) with inter-train interval (ITI) of 11 seconds (a total of 3000 stimuli per session) over the left dorsolateral prefrontal cortex (DLPFC).
15744170|NCT04907357|Device|Sham (Placebo)|Each sham rTMS session will consist of 75 rTMS trains of 10 Hz for 4 seconds (40 pulses per train) with inter-train interval (ITI) of 11 seconds (a total of 3000 stimuli per session) over the left dorsolateral prefrontal cortex (DLPFC). In the placebo condition the magnetic field will be delivered in the opposite direction (away from the brain).
15744171|NCT04907344|Drug|Camrelizumab|IV infusion
15744172|NCT04907344|Drug|Nab-Paclitaxel|IV infusion
15744173|NCT04907344|Drug|Carboplatin|IV infusion
15744174|NCT04907331|Biological|Vaxzevria|The participants either receive homologous vaccination with Comirnaty or Vaxzevria as approved or the new heterologous vaccination with Vaxzevria followed by Comirnaty
15744175|NCT04907331|Biological|Comirnaty|The participants either receive homologous vaccination with Comirnaty or Vaxzevria as approved or the new heterologous vaccination with Vaxzevria
15744176|NCT04907318|Device|Cataract surgery|
15744177|NCT04907292|Other|Obstetric Quality of Recovery-10 (ObsQoR-10©) Scoring Tool|The ObsQoR-10 tool aims to quantitatively measure functional recovery at 24 hours postpartum. It includes 10 questions on a 0 to 10 scale, aimed at pain management, the adverse effects of narcotics and the perception of recovery by the patient.
15744178|NCT04907279|Drug|Aripiprazole Once-Monthly (AOM)|Dosage and frequency of AOM administration individualized for each study participant in accordance with investigators' clinical judgment.
15744179|NCT04907266|Other|Structured Questionnaire|A structured proforma to assess outcome
15744180|NCT04907253|Drug|Quercetin|500 mg twice daily
15744181|NCT04907253|Drug|Placebo|twice daily
15744183|NCT04907227|Biological|Pembrolizumab|IV infusion
15744184|NCT04907227|Drug|Docetaxel|IV infusion
15744185|NCT04907227|Drug|Prednisone|Oral tablets
15744186|NCT04907227|Drug|Placebo|IV infusion
15744187|NCT04907227|Drug|Dexamethasone|Oral tablets
15744188|NCT04907214|Drug|Empagliflozin 25 MG|Oral empagliflozin daily
15744189|NCT04907201|Procedure|Cryoneurotomy|Cryoneurotomy or application of a low temperature probe with guidance of ultrasound which is offered to the patients with lower limbs refractory spasticity as a part of their medical cares.
15744190|NCT04907188|Biological|HB-adMSCs|The subject will receive 14 Intravenous infusions of 200 million cells each.
15744191|NCT04907175|Biological|HB-adMSCs|Subject will receive 9 infusions of 200 millions cells each
15744192|NCT04907162|Diagnostic Test|Beck depression inventory fast screen|Beck depression inventory fast screen questionnaire to detect severe depression for eligibility.
15744193|NCT04907162|Diagnostic Test|German Pain Inventory|German Pain Inventory questionnaire for evaluation of pain. Module A, abbreviated questions of module S (sociodemographic questions S1, S2, S3, S4, S5 and S8) and module L (quality of life) and V (therapies) will be used.
15744194|NCT04907162|Diagnostic Test|Brief Pain Inventory|Validated questionnaire for pain.
15744195|NCT04907162|Diagnostic Test|Fatigue Severity and Disability Scale (FSS)|Validated questionnaire for perceived fatigue
15744196|NCT04907162|Diagnostic Test|Quick Motor Function Test|An evaluator observes the performance of a patient and scores the items separately on a 5-point ordinal scale (ranging from 0 to 4). A total score is obtained by adding the scores of all items and ranges between 0 and 64 points.
15744197|NCT04907162|Diagnostic Test|Handheld Dynamometry (HHD)|To ensure a high level of objective measurement, muscle strength will also be assessed by handheld dynamometry. The following muscle groups will be tested: Arm abduction, elbow flexion, elbow extension, hip flexion, hip extension, knee extension, knee flexion, foot extension, foot flexion.
15744198|NCT04907162|Diagnostic Test|Six-minute walk test (6MWT)|It is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
15744199|NCT04907162|Diagnostic Test|Pressure pain threshold|"For diagnosis of myofascial pain, pressure algometers are designed and conventionally used to measure deep pressure pain thresholds or tenderness resistance (Park, Kim et al. 2011), and the reliability of pressure pain thresholds according to raters or measurement frequencies has been proven to be relatively high (Chung, Um et al. 1992). The threshold is then determined as the arithmetic mean of the 3 series (in kPa). The measurement will be stopped immediately as the patient feels sensations of burning, stinging, drilling or aching. Pressure algometry measurements will be performed on the trapezius, deltoid and supraspinatus muscles, the rectus femoris muscles, and the tibialis anterior muscles."
15744200|NCT04907162|Diagnostic Test|Myotonometer Assessment|Muscle stiffness, muscle tone, relaxation periods and viscoelasticity will be assessed by a myotonometer of selected muscles (non-invasive measurement). The method of measurement consists of recording damped natural oscillation of soft biological tissue in the form of an acceleration signal and the subsequent simultaneous computation of the parameters of State of Tension, Biomechanical and Viscoelastic properties. Measurements will be performed on the trapezius, deltoid and supraspinatus muscles, the rectus femoris muscles, and the tibialis anterior muscles.
15744202|NCT04907162|Diagnostic Test|Borg Scale|the Borg scale will be assessed, which is a self-reported questionnaire designed to subjectively assess dyspnea and exertion during activity (Borg 1982). The Borg scale rates dyspnea on a scale of 0 to 10 incorporating nonlinear spacing of verbal descriptors of the level of intensity of dyspnea. A higher Borg score indicates more severe dyspnea. The Borg scale will be administered before starting the 6MWT (≤ 5 minutes) and after completing the 6MWT (≤ 5 minutes).
15744203|NCT04907149|Drug|GLPG3970 film-coated tablet|Participants will receive a single oral dose of GLPG3970.
15744204|NCT04907149|Drug|[14C]GLPG3970 solution for infusion|Participants will receive an i.v. microtracer microdose.
15744205|NCT04907149|Drug|[14]GLPG3970 oral solution|Participants will receive a single oral dose [14C]GLPG3970.
15744206|NCT04907136|Other|Preferred ENDS|Preferred ENDS without HWL on device
15744207|NCT04907136|Other|Preferred ENDS with HWL|Preferred ENDS with a HWL on device
15744208|NCT04907123|Other|Intensive sodiuria-guided diuretic treatment|Intensive stepwise diuretic treatment based on combined diuresis and urinary sodium assessment
15744209|NCT04907123|Other|Standard diuretic treatment|Stepwise diuretic therapy based on diuresis assessment
15744210|NCT04907110|Dietary Supplement|Niagen|Participants in the NR supplementation + exercise group will undergo oral NR supplementation for 40 days. NiagenTM is the name for the dietary supplement containing NR (ChromaDex, Inc. Irvine, USA). The total dosage of NR per day will be 1000mg. This supplementation time of 40 days 1000mg/day
15744211|NCT04907110|Other|Exercise|During days 17-38 of the NR/placebo intake, participants will perform a 3-weeks supervised exercise training program with four ~30 min exercise sessions per week (two endurance session on a bike at 70%Wmax and two high intensity interval (HIIT) sessions.
15744212|NCT04907097|Dietary Supplement|Monomeric and oligomeric flavanols|Monomeric and oligomeric flavanols will be derived from Vitis vinifera seeds extract.
15744213|NCT04907097|Other|Placebo|Placebo capsuled will be used as a comparator.
15744214|NCT04907084|Dietary Supplement|Serine|Powdered serine supplement (Dosed out individually per participant. Participant to mix with water and ingest orally)
15744215|NCT04907084|Drug|Fenofibrate|Fenofibrate 160mg pill, taken orally
15744216|NCT04907071|Device|Intravascular ultrasound 0.035 PV IVUS catheter (Volcano Therapeutics, Rancho Cordova, CA)|The investigational 0.035 PV IVUS catheter (Volcano Therapeutics, Rancho Cordova, CA) is an over the wire catheter-based ultrasound with an 8.2-French profile at the transducer end and 7.0-French shaft diameter. This is run through a 9-French place under surface ultrasound guidance in the common femoral artery. The working length of this catheter is 90 cm, with the ability to imaging a diameter up to 60 mm.7
15744217|NCT04907058|Device|novel device with a comfortable mask|Using a device with a comfortable mask to supply constant low dose CO2 to treat patients.
15744218|NCT04907045|Behavioral|Health Coaching|The clinic is provided access to a health coach who conducts outreach with patients. The health coach facilitates engagement with the digital therapeutic and encourages contact with the care team.
15744219|NCT04907045|Behavioral|Practice Facilitation|In the context of a supportive relationship, a trained facilitator delivers the following interventions to clinic staff: Bolster Education, Audit and Provide Feedback, Support Plan-Do-Study-Act Cycles, Engage Others in Change.
15744220|NCT04907045|Behavioral|Standard Implementation|Brief clinician training and an implementation toolkit consisting of job aids, patient educational materials, scripted conversations, electronic health record tools, and a population management workbench.
15744221|NCT04907032|Drug|Mirabegron 50 MG|Posterior Tibial Nerve Stimulation with Mirabegron vs. Posterior Tibial Nerve Stimulation Plus Placebo
15744222|NCT04907032|Device|Posterior Tibial Nerve Stimulation (PTNS)|Posterior Tibial Nerve Stimulation with Mirabegron vs. Posterior Tibial Nerve Stimulation Plus Placebo
15744223|NCT04907019|Drug|rifampicin，SY-004|"On the morning of D1, the subjects will take orally 80 mg of SY-004 Capsules on an empty stomach.Fasting will be performed within 4 hours after taking the medicine. From D8 to D14, the subjects will take orally 600 mg rifampicin before breakfast every day. On the day of D15, the subjects will take orally 600 mg rifampicin and 80 mg SY-004 Capsules on an empty stomach.
~From D16 to D21, subjects will take orally 600 mg of rifampicin before breakfast every day.The patient can be discharged from the hospital after completing the safety examination on D22."
15744224|NCT04907006|Drug|SY-004 capsule|After fasting for 10 hours, subjects in group 1 took one SY-004 (80mg) orally on an empty stomach on the day of administration with 240ml warm water; Subjects in group 2 began to eat high-fat breakfast 30 minutes before administration , and took one SY-004 capsule（80mg） orally with 240ml warm water. The subjects in both groups were fasted within 4 hours after taking the medicine, and drinking water was forbidden within 1 hour before and after taking SY-004.
15744225|NCT04906993|Drug|camrelizumab； famitinib malate|Camrelizumab intravenously ; Famitinib Orally
15744226|NCT04906993|Drug|platinum-based chemotherapy|Physician's choice chemotherapy
15744227|NCT04906980|Drug|JNJ-64281802|JNJ-64281802 will be administered orally.
15744228|NCT04906980|Drug|Placebo|Matching placebo (PEG400) will be administered orally.
15744229|NCT04906967|Procedure|flaps|coverage of soft tissue defect around ankle
15744230|NCT04906954|Other|NMES|Standardized strength program (75 Hz frequency, 40 cycles). The stimulation intensity will be increased up to the highest tolerated level in order to evoke strong muscle contractions.
15744231|NCT04906941|Device|MRI|"SWI QSM 1.0iso 8 echos sequence performed before and after the injected MRI prescribed as part of the treatment.
~* Sense 2 * 2: 9min33s"
15744232|NCT04906928|Device|MRI|"standard imaging protocol prescribed as part of the usual treatment: sagittal T1 and T2 slices after injection of contrast product (Gadolinium), 3D STIR and 3D PSIR sequence.
~3D FGAPSIR sequence at the level of the cervical cord for the duration of the additional sequence is 10 minutes, for a total examination time of 40 minutes (instead of 30 minutes)"
15744233|NCT04906915|Drug|Ketamine|The efficacy of ketamine was assessed by calculating oxygen supply and consumption
15744234|NCT04906902|Drug|Acalabrutinib|Capsule taken by mouth twice daily
15744235|NCT04906889|Drug|Dexmedetomidine Hydrochloride|dexmedetomidine iv bolus for 10 minutes followed by the infusion of 0.1-1 ug/kg/h during general anesthesia
15744236|NCT04906889|Drug|Remifentanil Hydrochloride|remifentanil iv infusion of 0.5-5 ng/ml (effect site concentration using TCI) during general anesthesia
15744239|NCT04906876|Drug|Docetaxel|Docetaxel as a 60-minute IV infusion
15744243|NCT04906863|Other|Medical questionnaire|Collection of medical history
15744244|NCT04906837|Diagnostic Test|Trans aortic valve implantation|Measurement of the membranous septum on the pre TAVI scanner and the valve implantation height
15744245|NCT04906824|Device|great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing|VascuCel implantation in order to perform great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing
15744246|NCT04906811|Device|AuraGen 1-2-3 with AuraClens system (BK190433)|Fat grafting to the breast in patients undergoing an aesthetic procedure without a breast implant. Device used: AuraGen 1-2-3 with AuraClens system
15744247|NCT04906811|Device|Revolve System (K120902)|Fat grafting to the breast in patients undergoing an aesthetic procedure without a breast implant. Device used: Revolve System
15744248|NCT04906798|Drug|CKD-385|Test Drug
15744249|NCT04906798|Drug|D744|Reference Drug
15744250|NCT04906785|Drug|CKD-385|Test Drug
15744251|NCT04906785|Drug|D744|Reference Drug
15744252|NCT04906772|Drug|Dexmedetomidine|participants received loading of ketamine 1 mg/kg and dexmedetomidine 1µg/kg over 10 minutes then continue by a dose of 0.25 mg/kg/hr ketamine and 0.25µg/kg/hr dexmedetomidine throughout the procedure.
15744253|NCT04906772|Drug|Propofol|participants received loading of ketamine 1 mg/kg and propofol 1mg/kg over 10 minutes then continue by a dose of 0.25 mg/kg/hr propofol and 0.25µg/kg/hr dexmedetomidine throughout the procedure.
15744254|NCT04906759|Behavioral|Meals plus exercise|Participants will receive 12 weeks of a MOW delivery service that will include 2 meals per day during the weekdays with 4 shelf-stable meals at the end of the week. The MOW driver will visit the participants in-person to ask a series of 5 questions about change in health status, joint/muscle injuries, new pain, falls, and poor appetite twice a week. Participants will also will receive an exercise kit from the MOW driver with their first meal delivery which will contain 2 tennis balls, 2 1-pound hand weights, and one towel. Every week, the driver will give the participants a handout containing 3 exercises from the NIA Go4Life Workout-to-Go book that are designed to help with strength/endurance, balance, and flexibility20. The participants will be asked to do the 3 exercises every day, if possible, on their own. Every 4 weeks during the 12-week study period and at 6 months follow up patients will have blood drawn for frailty and inflammatory biomarkers.
15744255|NCT04906759|Behavioral|Meals only|Participants will receive 12 weeks of a MOW delivery service that will include 2 meals per day during the weekdays with 4 shelf-stable meals at the end of the week. The MOW driver will visit the participants in-person to ask a series of 5 questions about change in health status, joint/muscle injuries, new pain, falls, and poor appetite twice a week. they will be asked to continue their usual level of activity.Every 4 weeks during the 12-week study period and at 6 months follow up patients will have blood drawn for frailty and inflammatory biomarkers.
15744256|NCT04906746|Drug|Identify any dose-limiting toxicity (DLT) when ruxolitinib is administered to NSCLC cachexia patients.|There will be intra-patient dose escalation of ruxolitinib in every patient enrolled on study.
15744257|NCT04906733|Procedure|Tumor biopsy|Patients with RAS/RAF wild-type metastatic right colon cancer will receive biopsy before the standard treatment of chemotherapy or target therapy.
15744258|NCT04906720|Drug|Colchicine|colchicine 0.6mg oral twice daily for 7 days
15744259|NCT04906707|Device|EaseVRx|EaseVRx is a commercially available pain management program. It is a multi-modal, skills-based, 8-week, VR, mind-body approach to daily management of chronic pain that is designed for home use to be worn over the eyes. The program contains five types of modules that are as follows: Interoception, Education, 360-degree relaxation videos, Games, and Dynamic breathing. All program content is mapped to a therapeutically designed curriculum with weekly themes. The following core themes are infused into the curriculum: Acceptance, Attention shifting, Awareness, Rehabilitation, Self-compassion, Healthy Movement, Deep relaxation, Visualization, Knowledge of pain, Distraction, and Immersive enjoyment.
15744260|NCT04906707|Behavioral|Audio-only version of EaseVRx|Participants in the control group will be asked to use the audio-only version of EaseVRx, which excludes references to visual content, to complete 7 sessions weekly. They will receive an electronic link to the recordings on SoundCloud (a music streaming platform) where they can choose to stream or download the audio recordings on their smartphone, laptop, or desktop computer.
15744261|NCT04906694|Biological|COVI-DROPS|COVI-DROPS is a fully human monoclonal antibody which is a neutralizing antibody to SARS-CoV-2
15744262|NCT04906694|Drug|Placebo|Diluent solution
15744263|NCT04906681|Device|i-ACT|i-ACT is a Microsoft Kinect-based system that provides individualised exercises based on patients own goalsetting.
15744264|NCT04906668|Procedure|Pulmonary-vein isolation|Electrical isolation of the pulmonary veins with any form of energy
15744265|NCT04906668|Procedure|Ablation of atrioventricular-node and Pacemaker implantation|Ablation of atrioventricular-node and Pacemaker implantation
15744266|NCT04906655|Drug|Glycopyrronium 2.4 % Medicated Cloth|The investigational product (glycopyrronium cloth, 2.4%) is a pre-moistened, medicated cloth towelette that comes in individually wrapped packets. Subjects will receive marketed Qbrexza, one box, containing 30 pouches.
15744267|NCT04906642|Device|Next Science|Solution is a clear, colorless, aqueous solution that is used to remove debris, including microorganisms, from wounds via hydrodynamic shear across the wound. This aids in the removal of foreign material such as, microorganisms, dirt, and debris.
15744268|NCT04906642|Other|Standard of Care|Normal Saline will be used in place of Next Science for irrigation
15744269|NCT04906629|Biological|INO-4201|One dose of 1 mg of INO-4201 in 0.1 ml injected intradermally followed by electroporation with CELLECTRA2000
15744270|NCT04906629|Biological|Placebo|One dose of normal saline in 0.1 ml injected intradermally followed by electroporation with CELLECTRA2000
15744271|NCT04906616|Behavioral|Mlambe|A combined economic and relationship-strengthening intervention at the couple level to redirect funds spent on alcohol into financial investments (e.g., education, income-generating business) and to improve couple relationships and adherence to ART.
15744272|NCT04906603|Device|Theta Burst Stimulation|TBS will be administered three times per day and three days per week for four weeks (totaling 12 TBS intervention visits and 36 TBS intervention sessions). Each TBS intervention session will last approximately 10 minutes (stimulation parameters = 50 Hz, 3 pulses, 10 bursts, 10 second cycle time, 60 cycles, 1800 total pulses).
15744273|NCT04906590|Drug|[18F] PI-2620|Evaluation of the radiopharmaceutical imaging agent PI-2620 in detecting TAU brain burden.
15744274|NCT04906577|Other|photography+odour|Daily from D0 to D5: a square of cotton cloth will be placed against the child's scalp by the childcare worker in charge of the child, then removed and placed in a sealed box containing a photograph of the child, which will then be given to the mother.
15744275|NCT04906577|Other|photography|A neutral smelling cloth will be placed with the child's photograph which will then be given to the mother.
15744276|NCT04906564|Other|Identification of genetic variants|Identification of genetic variants
15744277|NCT04906551|Device|laser Doppler|A direct measure of blood flow
15744278|NCT04906538|Procedure|all- inside anterior cruciate ligament reconstruction|all- inside anterior cruciate ligament reconstruction with internal suture augmentation technique
15744279|NCT04906525|Behavioral|Resistance training|Participants will undergo 6 weeks of supervised resistance training
15744280|NCT04906525|Other|Conventional physical activity guidelines|Participants are given recommendations on physical activity guidelines
15744281|NCT04906512|Device|Tegaderm CHG Dressing|Tegaderm CHG dressing consists of a transparent adhesive dressing and an integrated gel pad containing 2% w/w chlorhexidine gluconate (CHG), a well-known antiseptic agent with broad spectrum antimicrobial and antifungal activity. The gel pad absorbs fluid. The transparent film provides an effective barrier against external contamination including fluids (waterproof), bacteria, viruses* and yeast, and protects the I.V. site. In vitro testing (time kill and zone of inhibition) demonstrates that the Tegaderm™ CHG gel pad in the dressing has an antimicrobial effect against a variety of gram-positive and gram-negative bacteria, and yeast. Tegaderm CHG dressing is transparent, allowing continual site observation, and is breathable, allowing good moisture vapor exchange.
15744282|NCT04906499|Behavioral|Physical Activity Promotion|"After enrolling, participants will be outfitted with a Fitbit Charge 2 activity monitor. The monitor will be worn during all waking hours, and compliance will be considered as a day with ≥ 1,000 steps. Participants will complete a 14-day run-in observation period while wearing the Fitbit but no PA promotion will occur. Individuals who are noncompliant during the run in period (<10 days with <1,000 steps) will be removed. Participants will receive a text message each morning with a personalized, daily step count goal and a link used to confirm receipt of the goal. The preceding 10 days of step data will be rank ordered and the 60th percentile step count will be set as the goal for the next day."
15744283|NCT04906473|Drug|KY100001|KY100001; Tablet; Oral route; Dose escalation and dose extension
15744284|NCT04906460|Drug|WVE-N531|WVE-N531 is an antisense oligonucleotide (ASO)
15744285|NCT04906447|Behavioral|Guided Relaxation|Guided relaxation uses the mind to reduce pain, promote well-being, and improve physical function. Guided relaxation is a state of concentration and focused attention that gives people more control over their pain experience and its impact and an increased sense of well-being.
15744286|NCT04906447|Other|Acupuncture|Acupuncture is a body-based therapy that includes the insertion of thin needles at strategic points on the body that has been proven effective for reducing pain.
15744287|NCT04906434|Drug|60mg ABSK-011capsule|Three 20mg capsules,QD for oral administration
15744288|NCT04906434|Drug|120mg ABSK-011capsule|One 20mg capsule and one 100mg capsule,QD for oral administration
15744289|NCT04906434|Drug|180mg ABSK-011capsule|One 100mg capsule and four 20mg capsules,QD for oral administration
15744290|NCT04906434|Drug|240mg ABSK-011capsule|Two 100mg capsules and two 20mg capsules,QD for oral administration
15744291|NCT04906434|Drug|320 mg ABSK-011capsule|Three 100mg capsule and one 20mg capsule,QD for oral administration
15744292|NCT04906434|Drug|400mg ABSK-011capsule|Four 100mg capsules,QD for oral administration
15744296|NCT04906408|Device|Prevena|Incisions will be dressed with closed incisional negative pressure wound therapy
15744297|NCT04906408|Device|Prineo|Incisions will be dressed with Prineo
15744298|NCT04906408|Drug|Traditional|Incisions will be dressed with bacitracin/xeroform
15744299|NCT04906395|Drug|TOL2506|Leuprolide Acetate for injectable suspension, 30 mg. Subcutaneous injection every 3 months.
15744300|NCT04906395|Drug|Tamoxifen|20 mg once daily or 10 mg 2 times daily - either tablet or solution
15744301|NCT04906395|Drug|Letrozole Tablets|One 2.5 mg tablet taken orally once daily
15744302|NCT04906395|Drug|Anastrozole Tablets|One 1 mg tablet taken orally once daily
15744303|NCT04906395|Drug|Exemestane Tablets|One 25 mg tablet taken orally once daily
15744304|NCT04906382|Procedure|Biopsy|Undergo biopsy
15744305|NCT04906382|Drug|Carboplatin|Given IV
15744306|NCT04906382|Drug|Paclitaxel|Given IV
15744307|NCT04906382|Biological|Tislelizumab|Given IV
15744308|NCT04906369|Procedure|Biospecimen Collection|Undergo collection of blood samples
15744309|NCT04906356|Genetic|Genetic sub-study|One time saliva sample collection
15744310|NCT04906343|Procedure|Colonoscopy|Colonoscopy surveillance in SPS patient after 3 years of the last colonoscopy.
15744311|NCT04906330|Diagnostic Test|Onco-liq: kit for breast cancer diagnosis.|Onco-liq is a novel diagnosis kit for early breast cancer diagnosis in blood, based on liquid biopsies and miRNAs. The main advantage of this kit is that miRNAs released from the tumor into the bloodstream can be detected in the plasma of patients even when the tumor is undetectable by other methods.
15744312|NCT04906317|Drug|midazolam and dezocine|Midazolam (0.05 mg/kg) and dezocine(5mg) sedation during colonoscopy, targeted to a painless level
15744313|NCT04906317|Drug|Propofol|standard propofol (1.5mg/kg) induction during colonoscopy, targeted to a moderate sedation level
15744314|NCT04906304|Drug|Everolimus Pill|standard dose versus low dose Sandimun
15744315|NCT04906304|Drug|Sandimmun (Neoral) dose plus cellcept|Sandimmun (Neoral) dose plus cellcept
15744316|NCT04906291|Other|Toothpaste use|Brushing three times a day
15744317|NCT04906278|Device|Foley catheter balloon|A Cusco speculum will be placed and a 16F Foley catheter will be inserted into the cervix using ring forceps. Then the balloon will be inflated with 40 ml of saline and it will be pulled out to ensure the balloon covered the internal os of the cervix
15744347|NCT04906057|Behavioral|Voluntary Aerobic Exercise (VE)|Voluntary-rate aerobic exercise on a semi-recumbent stationary cycle ergometer
15744348|NCT04906044|Drug|Tilelimumab|Tilelimumab combined withTotal Neoadjuvant Treatment
15744318|NCT04906278|Procedure|Amniotomy|Amniotomy will be performed by toothed forceps. The handle of the device will be held with one hand outside the vagina while 2 fingers of the opposite hand will be placed in the vagina to guide the tip. Care should be taken to protect maternal vaginal tissues from the forceps. Once the forceps reach the amniotic sac, the tip is pushed up against the sac with the index or middle finger of the internal hand to pierce the membranes. The nature of amniotic fluid will be checked.
15744319|NCT04906278|Drug|Oxytocin|The intravenous oxytocin infusion will be administered as 10 IU oxytocin/ 500 ml glucose/ 30 mIU/minute were every 6 hours till complete abortion occurs.
15744320|NCT04906265|Other|Intervention A|the intervention comprises the HIFE protocol as a rehabilitation method and, if necessary, other completing exercises. HIFE consists of five exercise categories depending on the capabilities of the patient.
15744321|NCT04906265|Other|Intervention B|the intervention comprises the HIFE protocol as a rehabilitation method and, if necessary, other completing exercises. HIFE consists of five exercise categories depending on the capabilities of the patient. In addition, follow-up and feedback during the rehabilitation period will be given via a wearable inertial measurement unit (IMU).
15744322|NCT04906265|Other|Control intervention|the intervention comprises the standard rehabilitation services: walking training and adaptions to the walking pattern of the patient prior to surgery together with functional exercises
15744323|NCT04906252|Diagnostic Test|Echocardiography|Patients presenting in cardiac arrest will undergo echocardiography as is the standard of care at their institution
15744324|NCT04906252|Diagnostic Test|Electrocardiogram (ECG)|Patients presenting in cardiac arrest will undergo an electrocardiogram (ECG) as is the standard of care at their institution
15744325|NCT04906239|Procedure|Erector Spinae Plane Block|A high-frequency ultrasound linear probe, covered with a sterile sheath, will be placed approximately 2 cm to the right or left of the T 4-5 spinous process. After showing the T 4-5 transverse process and the erector spinae muscle on top of it, a 22-gauge, 80 mm insulated quincke type needle will be inserted into the skin at an angle of approximately 30 degrees from cranial to caudal, using the in-plane technique. When the transverse process is touched, the needle will be pulled out and after a negative aspiration test with 0.5 mL of normal saline and after the demonstration of a hypo-echogenic image and hydro dissection, a local anesthetic solution will be applied to the fascia beneath the erector spinae muscle. A 20 mL dose of 0.25% bupivacaine, which has been shown to spread both above and below the T 4-5 level, will be injected.
15744326|NCT04906226|Behavioral|Self-foot massage|The individuals in the foot massage group will be given foot massage training by the researcher. Later, people with diabetes will be enabled to continue self-massage at home. To encourage the continuation of the intervention, the researcher will be called once a week by phone and her questions will be answered. At the end of the four weeks, the patient will be interviewed again and data collection forms will be filled.
15744327|NCT04906213|Drug|Dapagliflozin 10Mg Tab|Dapagliflozin 10 Mg daily or placebo daily for 18 months
15744328|NCT04906213|Drug|Placebo|10Mg Placebo Tab
15744329|NCT04906200|Other|Best Practice|Receive usual care
15744330|NCT04906200|Other|Internet-Based Intervention|Receive access to YES portal
15744331|NCT04906200|Other|Survey Administration|Complete survey
15744332|NCT04906187|Other|Arm A : intraoperative ANI monitoring of nociception|For the experimental group (arm A), the sufentanil doses are adjusted to maintain an ANI between 50 and 70. Morphine doses are adjusted from 0.05 to 0.05 µg / ml. Intraoperative data will be collected for ANI, TIVA and hemodynamics.
15744333|NCT04906187|Other|Arm B : no specific monitoring of nociception|For the control group (arm B), adjustments to the opioid doses are made in relation to the hemodynamic reactions of the patient and the operating times. Intraoperative data will be collected for TIVA and hemodynamics.
15744334|NCT04906174|Other|Electronic Health Record Review|Medical records are reviewed
15744335|NCT04906161|Diagnostic Test|Vitamin D and calcium levels|Mini VIDAS® compact multiparametric immunoanalyzer for vitamin D analysis (BIOMERIEUX- France)
15744336|NCT04906148|Other|Advertisement content (explicit vs. implicit)|Participants will be randomly assigned to view an advertisement with either implicit or explicit harm messaging content
15744337|NCT04906148|Other|Advertisement content (true vs. misleading)|Participants will be randomly assigned to view an advertisement with either true or misleading messaging content
15744338|NCT04906135|Other|Experimental manipulation of stimulation parameters|This translational mechanistic study involves changing stimulation parameters (i.e., experimental manipulation) for measuring the electrically evoked compound action potential in order to understand the pathophysiology of the auditory system in patients with Usher syndrome.
15744339|NCT04906122|Other|The grandmothers in the intervention group will be given breastfeeding counseling before discharge. Home monitoring will be performed in the 2nd week, 3rd and 6th months after the counseling.|The research was planned as a randomized controlled study. Voluntary postpartum primiparous mothers who have recently given birth and their accompanying grandmothers will be randomly assigned to the intervention and control group. The grandmothers in the intervention group will be given breastfeeding counseling before discharge. Home monitoring will be performed in the 2nd week, 3rd and 6th months after the counseling. In each follow-up, breastfeeding knowledge and attitudes of the grandmothers, breastfeeding success of mothers, attitude towards breastfeeding, perception of postpartum support and newborn growth parameters will be determined. As a result of the research, the effect of breastfeeding training given to grandmothers will be evaluated breastfeeding status of the first 6 months, self-efficacy, attitude, social support perceptions, breastfeeding continuity and newborn growth parameters of primiparous mothers who have just given birth.
15744340|NCT04906109|Drug|Vemlidy Tab|1T
15744341|NCT04906109|Drug|DA-2803 Tab|1T
15744342|NCT04906096|Drug|PAXALISIB|Each study treatment cycle lasts 28 days, up to 24 months. Oral, daily, dosage per protocol
15744343|NCT04906083|Drug|Avatrombopag|"Avatrombopag:
~PLT：30~50×10^9/L patients, 40 mg/d; PLT：<30×10^9/L patients, 60 mg/d."
15744344|NCT04906083|Drug|Standard medical treatment|Standard medical treatment included transmetil, compound glycyrrhizinate, reduced glutathione and hepatocyte growth factor, et. al.
15744345|NCT04906070|Device|HB-001|An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.
15744346|NCT04906057|Behavioral|Forced Aerobic Exercise (FE)|High-rate aerobic exercise on a semi-recumbent custom-designed stationary cycle ergometer
15744349|NCT04906031|Drug|Sodium stibogluconate|Sodium stibogluconate 900 mg/m2/day will be given on d1-5 and d15-19. 28 days per cycle.
15744350|NCT04906018|Device|Ultrasound scans|Each subject will be randomly allocated to an ultrasound machine and an expert scanner who will perform the ultrasound scans of all supported anatomical regions.
15744351|NCT04906005|Drug|gadopiclenol|administration by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a saline flush of at least 5 mL at the same rate to ensure complete injection of the contrast agent.The gadopiclenol administration is performed by power injecto
15744352|NCT04906005|Drug|Placebo|intravenous (IV) bolus injection at 2 mL/s, followed by a saline flush of at least 5 mL to be in the same conditions as for gadopiclenol administration.The gadopiclenol administration is performed by power injector
15744353|NCT04905992|Other|Hypertonic saline at 6%|Participants will start the sessions by inhaling a short-acting bronchodilator or an anticholinergic to avoid the presence of bronchospasm during nebulisation. The hypertonic solution (at 6%) will be administered through the Turbo Boy nebuliser (Pari®). The intervention will take place at home.
15744354|NCT04905992|Other|Airway clearance techniques (oscillating positive expiratory pressure therapy)|Following nebulisation, participants will perform airway clearance techniques using an oscillating positive expiratory pressure device for at least 15 minutes. The intervention will take place at home
15744355|NCT04905979|Drug|AD113|Two oral capsules administered before bed
15744356|NCT04905979|Drug|Atomoxetine|Two oral capsules administered before bed
15744357|NCT04905966|Behavioral|Nutrition education and Physical activity intervention|Schools randomized to the experimental group received nutrition education sessions and physical activity classes.
15744358|NCT04905953|Drug|Neostigmine|Intrathecal injection of two doses of neostigmine (10 & 20 mic) during spinal anesthesia for cesarean section.
15744360|NCT04905927|Other|phone survey|A questionnaire about the current symptoms and satisfaction for received treatment will be conducted over the phone for patients.
15744361|NCT04905914|Drug|ATRN-119|ATRN-119 is a capsule formulation that will be supplied as 50 mg and 200 mg hydroxymethyl cellulose (HPMC) capsules packed in sealed plastic bottles (n=30) and dispensed by the site pharmacist in combinations to provide the appropriate dose.
15744362|NCT04905901|Drug|Tranexamic acid|Tranexamic acid nebulization 15 minutes before sinus surgery
15744363|NCT04905901|Other|Saline placebo|Normal saline placebo nebulization 15 minutes before sinus surgery
15744364|NCT04905888|Combination Product|Hyperbaric oxygen therapy|Subjects randomized to treatment will receive up to ten 90 minute treatments with hyperbaric oxygen over a 2-3 week period.
15744365|NCT04905875|Procedure|Prone Position|Every center will prescribe PP in accordance with local practice and local levels of expertise. No variation in treatment prescription and/or treatment solutions will derive from participation in this prospective observational study. Nonetheless, every setting parameter will be recorded in the web-based registry and analyzed a-posteriori to reveal a potential correlation with the patient outcomes.
15744366|NCT04905862|Diagnostic Test|Immune response|"Venous blood samples will be collected at seven-time points: before dose 1 of vaccine, 21 days after dose 1, within 14-21 days after dose 2 and 3,6,9,12 months after vaccination. From the volume of about 8 ml of the patient's peripheral blood, a fraction of PBMC (peripheral blood mononuclear cells) will be isolated.
~The level of antibodies against the SARS-CoV-2 nucleocapsid (N) antigen will be detected in serum using the Abbot Architect™SARS-CoV-2 IgG test.
~The level of neutralizing IgG and IgA antibodies against the SARS-CoV (S1 and S2 subunits) (S) will be detected in serum using the DiaSorin LIAISON®SARS-CoV-2 S1/S2 IgG serology COVID-19 S-Protein (S1RBD) Human IgA ELISA Kit respectively.
~The cellular component of the immune response will be tested using the ELISPOT method, which involves testing the amount of INF-γ and IL-2 released from leukocyte cells."
15744367|NCT04905862|Other|Solicited common and expected adverse reactions shortly following vaccination (reactogenicity), use of antipyretic or pain medications and unsolicited adverse events and serious adverse events|The grading scales for side effects used in this study will derive from the FDA Center for Biologics Evaluation and Research guidelines on toxicity grading scales for volunteers enrolled in preventive vaccine clinical trials. Solicited reactions will be obtained 7 days after the first and the second dose, and 30 days after the final vaccination. Unsolicited adverse events and serious adverse events will be observed recorded through 1 month after the second dose
15744368|NCT04905849|Behavioral|Adaptive Cognitive Control Trainer (ACCT)|"Module 1: Attention=> This module demands an active scan of the screen in search for a target, much like traditional visual search tasks. Participants quickly identify the direction that a probe target is facing (up, down, left, right), and are aided by the presence of directional cue indicating where the location of the target will appear.
~Module 2: Goal Management=> Requires participants to rapidly switch their focus based on distinct rules. Participants are presented with exemplar objects along with a target, and are asked to indicate which exemplar presented is most like the target.
~Module 3: Working Memory=> Engages spatial working memory resources similar to the Corsi block task. Participants memorize the location of objects on screen followed by a 5-7 second delay period, with a correct response leading to a greater number of potential targets to be memorized on the next trial (and vice versa)."
15744369|NCT04905849|Behavioral|Active Control App|The app used here is undergoing expectancy-matching at the present time, will be updated with the final app characteristics when completed out of a list of several possibilities
15744372|NCT04905823|Diagnostic Test|blood test|assessment of humoral, immune cell response and glycemia
15744373|NCT04905810|Drug|Azacitidine|Given IV
15744374|NCT04905810|Drug|Decitabine|Given IV
15744375|NCT04905810|Drug|Venetoclax|Given PO
15744376|NCT04905797|Diagnostic Test|Emotional Stop Signal Task|Emotional Stop Signal Task (modified version from CANTAB). Outcome Measure is commission and omission errors - higher score (percentage) indicate worse performance.
15744377|NCT04905797|Diagnostic Test|Magnetic Resonance Imaging|Functional Magnetic Resonance Imaging (fMRI) Diffusion Tensor Imaging (DTI) Volumetry
15744400|NCT04905641|Procedure|Bilateral intermediate cervical plexus block|Bilateral intermediate cervical plexus block was performed under ultrasound guidance.
15744378|NCT04905797|Other|World Health Organizations Disability Assessment Schedule (WHODAS 2.0)|Self-reported data on World Health Organizations Disability Assessment Schedule - 36 items self-administered (WHODAS 2.0). Assessing six domains of functional disability in daily life. Each item is rated on a Likert scale ranging from 0-4. Total range 0 - 144. High scores scores indicate more severe disability.
15744379|NCT04905797|Diagnostic Test|Personality Inventory for DSM-5 (PID-5)|Self-rated personality traits through Personality Inventory for DSM-5 (PID-5). Self-reported scores on domains of personality traits. Higher scores in one domain indicate more pronounced traits in this domain.
15744380|NCT04905797|Diagnostic Test|Stop Signal Task (CANTAB)|The estimate of time where an individual can successfully inhibit their responses 50% of the time.
15744381|NCT04905797|Diagnostic Test|Intra-Extra Dimensional Set Shift (CANTAB)|"The number of trials for which the outcome was an incorrect response (subject pressed the incorrect button within the response window), calculated across all assessed trials.
~The total number of times that the subject chose a wrong stimulus - i.e. one incompatible with the current rule, adjustment for every stage that was not reached."
15744382|NCT04905797|Diagnostic Test|Spatial Working Memory Test (CANTAB)|"The number of times the subject incorrectly revisits a box in which a token has previously been found. Calculated across all assessed four, six and eight token trials.
~The number of times a subject begins a new search pattem from the same box they started with previously. If they always begin a search from the same starting point, we infer that the subject is employing a planned strategy for finding the tokens. Therefore, a low score indicates high strategy use (1 = they always begin the search from the same box), a high score indicates that they are beginning their searches from many different boxes. Calculated across assessed trials with 6 tokens or more."
15744383|NCT04905797|Diagnostic Test|Multitasking Test (CANTAB)|"The number of trials for which the outcome was an incorrect response.
~The median latency of response (from stimulus appearance to button press). Calculated across all correct, assessed trials.
~The difference between the median latency of response on the trials that were congruent versus the trials that were incongruent. A positive score indicates that the subject is faster on congruent trials and a negative score indicates that the subject is faster on incongruent trials. A higher incongruency cost indicates that the subjects take longer to process conflicting information.
~The difference between the median latency of response during assessed blocks in which both rules are used versus assessed blocks in which only a single rule is used. A positive score indicates that the subject responds more slowly during multitasking blocks and indicates a higher cost of managing multiple sources of information."
15744384|NCT04905797|Diagnostic Test|Cambridge Gambling Task Test|"The proportion (0 - 1) of all trials where the subject chose the majority box color. Calculated over all assessed trials from both the ascending and descending conditions in which the number of boxes of each color differed.
~Risk adjustment is a measure of sensitivity to risk, based on the ability to modify choices in the light of information about the probability of different outcomes and to track the optimal outcome on eaeh trial. The measure is calculated from the average proportion of points that the subject ehose to bet with, taking into aeeount the number of colored boxes in the majority.
~Allows for the dissociation between risk taking and impulsivity by determining whether subjects simply just place a bet at the first opportunity. Calculated as CGT Risk Taking for all trials from the descending condition minus CGT Risk Taking for all trials from the ascending condition."
15744385|NCT04905784|Behavioral|Differential learning|The patient will be requested to perform different exercises, each exercise one time a day for 3 days in a row before moving to the next exercise. All patient will be asked to do the exercises in the same sequence.
15744386|NCT04905784|Behavioral|Usual toothbrushing|The patients in this group will be provided with the regular oral health instructions, including the traditional toothbrushing recommendations.
15744387|NCT04905758|Procedure|platform switching|reduced implant abutment interface
15744388|NCT04905758|Procedure|platform amtching|matched implant abutment interface
15744389|NCT04905745|Procedure|Korean integrative medicine|"Any kind of Korean integrative medicine will be applicable and the treatment will be entirely determined by experienced clinicians. On the premise of the above, the following examples are the treatments applicable to the subject of this observational study.
~Chuna: Chuna therapy is performed on the face and cervical spine to induce decompression of the captured facial nerve. In addition, SJS Non-Resistance Technique-Facial palsy (SJS NRT-F), a technique of Chuna, can be performed to stimulate the intrinsic receptive sensation of the facial muscles to promote the neuromuscular response.
~Acupuncture: acupuncture can be applied on paralyzed muscle and others to improve symptoms and paralysis status.
~Pharmacopuncture: pharmacopuncture can be applied on paralyzed muscle and others to improve symptoms and paralysis status.
~Herbal medicine: It is prescribed according to clinical judgment according to the patient's symptoms and disease status."
15744390|NCT04905732|Device|NHFOV|After documenting parental consent, the ventilated infants with BPD were randomly assigned to NHFOV
15744391|NCT04905732|Device|NCPAP|After documenting parental consent, the ventilated infants with BPD were randomly assigned to NCPAP
15744392|NCT04905719|Diagnostic Test|Ultrasound|Each patient included to the study will undergo Point-of-Care ultrasound testing specific for the area defined in the Groups section.
15744393|NCT04905693|Drug|Inhaled Treprostinil|Inhaled Treprostinil (6 mcg/breath) administered QID
15744394|NCT04905693|Device|Treprostinil Ultrasonic Nebulizer|Treprostinil ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath.
15744395|NCT04905680|Device|CGM lifestyle tracking and coaching|"Participants in the experimental group will go through a total of 5 lifestyle tracking sessions (including baseline), of which 1 will include CGM tracking. For this CGM lifestyle tracking session, experimental group participants will receive real-time feedback through the study applications, which will display the CGM trace.
~The data collected during the lifestyle tracking sessions will be discussed with the participants during 3 face-to-face coaching and 2 tele-coaching sessions, where the participants will develop and implement lifestyle change action plans."
15744396|NCT04905667|Drug|GB221|6 mg/kg, single dose, intravenous infusion, 90-100 min
15744397|NCT04905667|Drug|Herceptin|6 mg/kg, single dose, intravenous infusion, 90-100 min
15744398|NCT04905654|Drug|Levcromakalim|To investigate the role of levcromakalim compared with placebo in migraine with aura patients
15744399|NCT04905654|Drug|Saline|To investigate the role of levcromakalim compared with placebo in migraine with aura patients
15744401|NCT04905628|Device|Dexcom CGM System|Dexcom CGM System
15744402|NCT04905615|Other|Data-driven and teacher led school based strategies.|The intervention is individualised to each school, depending on the teacher led strategies which are data-informed
15744403|NCT04905602|Drug|SHR-1905/placebo|"Drug: SHR-1905 subcutaneous, single dose
~Drug: Placebo subcutaneous, single dose"
15744404|NCT04905589|Dietary Supplement|BetaQuik™|MCT (Medium chain triglycerides)
15744405|NCT04905589|Dietary Supplement|WheyBasics|Whey Protein Isolate
15744406|NCT04905589|Other|Iso-voluminous water|Iso-voluminous Water as comparitor to Betaquik or WheyBasics
15744407|NCT04905576|Behavioral|Relaxation training|Muscle relaxation training
15744408|NCT04905576|Behavioral|Therapeutic touch|Healing Touch (HT) therapy
15744409|NCT04905576|Other|Questionnaire administration|
15744410|NCT04905576|Other|Ancillary studies|Subjects in all groups will give 4 blood samples during the study
15744411|NCT04905563|Drug|Acetaminophen-Hydrocodone|Narcotic
15744412|NCT04905563|Drug|Acetaminophen and Ibuprofen|Non-narcotic
15744413|NCT04905550|Drug|Almonertinib|Almonertinib 110mg p.o qd. Treatment with Almonertinib will continue until progression or unacceptable toxicity.
15744414|NCT04905550|Radiation|Stereotactic Radiotherapy(SRT) or Stereotactic Radiosurgery(SRS) or Whole-Brain Radiotherapy(WBRT)|Image guided, 24-15 Gy*1F was recommended if use SRS. 9-12 Gy*3F/1W or 6Gy×5F/1W was recommended if use SRT. 30Gy/10F/2W for WBRT, large residual lesions will be treated with a local dose (≤DT 45Gy/15F).
15744415|NCT04905537|Other|No intervention|It's only observational study. No interventions.
15744416|NCT04905524|Dietary Supplement|VIOME Precision Nutrition Program|Diet and supplements recommendations
15744417|NCT04905511|Biological|natural human collagen arteriovenous graft for hemodialysis access|The True Vascular Graft will be implanted in the forearm or upper arm in a straight or curved configuration.
15744418|NCT04905498|Behavioral|Commercial Advertising Literacy Training|"Children were shown food commercials and in between those commercials they saw and heard statements such as These foods won't make you happy and Those foods are so unhealthy."
15744419|NCT04905498|Behavioral|Control|Children were shown food commercials that were the same length as the other group but did not receive any information about whether the content was truthful.
15744420|NCT04905485|Behavioral|VIOME Precision Nutrition Program|Precision diet and supplement recommendations based on participants' microbiome results.
15744421|NCT04905472|Device|Vestibular prosthesis/implant|The intervention is a vestibular prosthesis which our collaborators at the University of Geneva are implanting into the inner ear in deaf patients without vestibular function who are receiving a cochlear implant. The vestibular implant (VI) has three rate sensors and senses angular head velocity in three dimensions and provides this information to the brain by stimulation the afferent nerves innervating the three semicircular canals. Our goal is to use the VI to better understand how the brain processes this prosthetic information and uses it to generate meaningful behavioral responses including eye movements, postural control, and perception.
15744422|NCT04905472|Device|Vestibular Implant Stimulation|VI subjects will be studied before the implant is activated (pre) and then after it is turned on (acute On); this will take about 2 hrs. Then they will have 8 hours of motion-modulated VI stimulation while they actively explore the hospital environment, after studies will be repeated (chronic On). Each set of outcome experiments will be performed twice, once with and once without low-levels of stochastic noise added to the VI stimulation provided for the 8-hour period. The noise amplitude is tailored to each patient to maximize stochastic resonance so extraction & integration of spatial signal provided by the VI will always be the first experiment, but the order of the subsequent outcome sessions (active/passive head rotations, tilt/translation motion discrimination and VOR behavioral changes & postural control) will be randomized. VI subjects will participate in 4 full-day sessions, each separated by at least a month.
15744423|NCT04905459|Diagnostic Test|ARDA software application|Subject images will be sent to the investigational ARDA software
15744424|NCT04905446|Other|Deuterated nicotinamide (D4-NAM) IV infusion|Nicotinamide adenine dinucleotide (NAD) is a vitally important substance that is found in all cells of the body. D4-NAM (in normal saline) will be infused via an indwelling catheter.The IV infusion will continue for 8 hrs.
15744425|NCT04905446|Procedure|Skeletal muscle biopsy|Participants will have a muscle biopsy performed on the muscle in the thigh. We will collect a small sample of blood before the biopsy. This procedure is used to sample muscle cells from the right or left leg Vastus Lateralis (thigh) muscle.
15744426|NCT04905446|Procedure|Skin tissue biopsy|This procedure is used to sample skin tissue from the upper thigh via a punch biopsy.
15744427|NCT04905433|Behavioral|Cardiac rehabilitation with breathing retraining|A cardiac rehabilitation program for 3 days/week (day after day) for 12 weeks(including aerobic, and resisted exercise, with educational sessions, and counseling), with a breathing retraining (using breathing calisthenics, and inspiratory muscle training)
15744428|NCT04905433|Behavioral|Cardiac rehabilitation|A cardiac rehabilitation program for 3 days/week (day after day) for 12 weeks(including aerobic, and resisted exercise, with educational sessions, and counseling) only
15744432|NCT04905394|Procedure|subchondroplasty|subchondroplasty is an innovative percutaneous procedure in which calcium phosphate, biocompatible material similar to the native bone apatite with osteoinductive properties, is injected inside BML areas. The purpose of subchondroplasty is the patient's symptoms relief, improving the mechanical strength of subchondral bone, stimulating bone remodeling to avoid bone sagging, and slow down the arthritic degenerative process to postpone arthroplasty.
15744435|NCT04905368|Other|SS-POR11|Topical composition containing probiotic strains derived from human skin (SS-POR11). Participants will be instructed to apply it topically to face, twice weekly for the duration of the trial.
15744436|NCT04905355|Device|Virtual reality|The VR used during the ambulatory orthopedic surgery allows immersive experience in HD-2D virtual environment. Patient can choose among movies, cartoons, entertainments offered for visualization during the surgery
15744437|NCT04905342|Drug|NVP-1805|orally, once daily on Period 1 and Period 3 (or Period 2 and Period 4) (NVP-1805 80/10/20.8mg)
15744438|NCT04905342|Drug|NVP-1805-R1and NVP-1805-R2|orally, once daily on Period 1 or Period 3 (or Period 2 and Period 4) (NVP-1805-R1 80mg, NVP-1805-R2 10/20.8mg)
15744439|NCT04905329|Drug|Empegfilgrastim|Extimia®
15744440|NCT04905316|Drug|Canakinumab|Treatment will consist of canakinumab (ACZ885) administered as a subcutaneous injection every 3 weeks for 3 cycles concurrent with standard of care concurrent chemoradiation, followed by canakinumab (ACZ885) administered intravenously every 4 weeks for up to 12 total infusions concurrent with standard of care durvalumab.
15744441|NCT04905316|Drug|Durvalumab|Consolidative durvalumab therapy will be as per standard of care in accordance with institutional practice and at the discretion of the treating oncologist.
15744442|NCT04905316|Radiation|Radiation therapy|Radiation therapy will be performed with external beam ionizing radiation as per standard of care in accordance with institutional practice. Intensity-modulated radiation therapy (IMRT) or volumetric arc therapy (VMAT) will be used at the discretion of the treating radiation oncologist. Patients will be simulated in the treatment position with standard immobilization techniques for thoracic radiotherapy. The prescription dose will be 60 Gy (±10%) in 2Gy fractions to fields encompassing gross tumor and lymph nodes, as per institutional guidelines. The dose must satisfy institutional guidelines and minimize risk to adjacent organs at risk.
15744443|NCT04905316|Drug|Chemotherapy|Chemotherapy will be as per standard of care in accordance with institutional practice. Patients will be treated with carboplatin or cisplatin with etoposide, paclitaxel, albumin-bound paclitaxel or pemetrexed at the discretion of the treating thoracic medical oncologist. Chemotherapy will be concurrent with radiation therapy as per standard practice, with cycle 1 day 1 of chemotherapy starting on fraction 1 of radiation ± 5 days.
15744444|NCT04905290|Device|Left ventricular coronary sinus configuration|For subjects with a pacemaker, pacing of the left ventricular coronary sinus only. For subjects with a defibrillator, biventricular pacing of the left ventricular coronary sinus and the right ventricle.
15744445|NCT04905290|Device|Conduction system pacing-only configuration|Conduction system pacing (CSP) of the left bundle branch.
15744446|NCT04905290|Device|Conduction System Pacing Optimized Therapy (CSPOT) configuration|A combination of left ventricle (LV) pacing and conduction system pacing (CSP) of the left bundle branch.
15744447|NCT04905277|Drug|Atenolol 50 MG|50 mg Atenolol daily
15744448|NCT04905277|Drug|Placebo|one placebo daily
15744449|NCT04905251|Drug|Mifepristone-Misoprostol|Non interventional design.
15744450|NCT04905238|Device|Continuous positive airway pressure|Continuous positive airway pressure
15744451|NCT04905225|Procedure|Ascending aortic replacement|Surgical access will be performed through a median sternotomy. Ascending aortic repair is performed under conditions of cardiopulmonary bypass (CPB) and MHCA with unilateral ACP via innominate artery with a flow rate of 8-10 ml/kg/min and perfusion pressure of 60-80 mmHg. Once CPB is instituted, the aortic cross-clamp is applied, and the heart is arrested with antegrade cardioplegia. Hemiarch replacement involves resection lesser curve of the aortic arch from the base of the innominate artery (Zone 0) to a point immediately distal to the nadir of the lesser curvature (Zone 3 or Zone 2 if the left subclavian artery was too far).
15744452|NCT04905212|Drug|Telitacicept 160mg|Subcutaneous injection Telitacicept 160mg. The injection site can be at the thigh, abdomen, or upper arm.
15744453|NCT04905212|Drug|Telitacicept 240mg|Subcutaneous injection Telitacicept 240mg. The injection site can be at the thigh, abdomen, or upper arm.
15744454|NCT04905212|Drug|Placebo|Subcutaneous injection placebo. The injection site can be at the thigh, abdomen, or upper arm.
15744455|NCT04905199|Procedure|Temporary transvenous cardiac pacing|Transvenous temporary pacemaker insertion by modified IC-ECG monitoring.
15744459|NCT04905160|Other|COMPASSION Digital Biomarker|Vitals data collected by the Vitalbeat workbench for biomarker based algorithm variables will be used to drive intervention based on PAP systolic and diastolic pressures.
15744460|NCT04905147|Drug|Mosapride|Mosapride citrate is prokinetic drug that selectively activates 5-HT4receptors. Mosapride stimulates serotonin receptor in the digestive tract and increases acetylcholine release to promote upper digestive tract (stomach and duodenum) and lower digestive tract (colon) motility and gastric emptying without cardiac side effects
15744461|NCT04905147|Drug|Placebo|Placebo drug 15 mg
15744463|NCT04905121|Drug|Psilocybin|Psilocybin will be provided in form of dry filled capsules and administered orally in three ascending doses
15744464|NCT04905108|Drug|Riboflavin|Administration of riboflavin one drop every 2 minutes during UVA exposure
15744465|NCT04905108|Drug|Riboflavin|Administration of riboflavin one drop every 10 minutes during UVA exposure
15744466|NCT04905095|Diagnostic Test|EWS|Early Warning Score will be implemented in the computer system of the nursing station. When the nurses enter the vital signs of the patients into the system, the EWS will be automatically calculated and an alarm will be displayed if an intervention is necessary, which is protocolized.
15744467|NCT04905082|Other|Best Practice|Receive usual care
15744468|NCT04905082|Other|Educational Intervention|View HOPE-Genomics tool after genomic test results are available
15744469|NCT04905082|Other|Educational Intervention|View HOPE-Genomics before sequencing results are available
15744470|NCT04905082|Procedure|Genomic Profile|Receive genomics test results
15744471|NCT04905082|Other|Survey Administration|Ancillary studies
15744473|NCT04905056|Other|Ablation therapy|Ablation therapy in the treatment of lung cancer presenting as ground-glass nodules
15744474|NCT04905043|Drug|Acalabrutinib|Participants will receive a single oral dose of acalabrutinib 100 mg capsule on Day 1 (Period 1) and Day 4 (Period 2).
15744475|NCT04905043|Drug|SmartPill®|Participnats will receive a single oral dose of wireless motility/pH capsule (SmartPill®) on Day 1 (Period 1) and Day 4 (Period 2).
15744476|NCT04905030|Behavioral|Information T1|A4 information sheet on HPV vaccine containing a reminder of the upcoming HPV vaccination, and information on: (i) its safety and efficacy in preventing a number of cancerous diseases, affecting both women and men; (ii) what is HPV and how contagion happens; (iii) the consequences of cervical cancer for women, in terms of invasive medical treatments and temporary or permanent loss of fertility. The information is framed in non-scientific, non-statistical terms and is emotionally charged: the consequences of cervical cancers are portrayed by testimonies of cancer survivors from Sweden.
15744477|NCT04905030|Behavioral|Information T2|A4 information sheet on HPV vaccine containing a reminder of the upcoming HPV vaccination, and information on: (i) its safety and efficacy in preventing a number of cancerous diseases, affecting both women and men; (ii) what is HPV and how contagion happens; (iii) the consequences of cervical cancer for women, in terms of invasive medical treatments and temporary or permanent loss of fertility. The information is framed in scientific terms and incidence and mortality statistics are reported. The information is not emotionally charged but rather aseptic.
15744478|NCT04905030|Behavioral|Information C|A4 information sheet containing a reminder of the upcoming HPV vaccination, and information on the history and characteristics of the Swedish national vaccination program.
15744479|NCT04905017|Device|Transcatheter Tricuspid Valve Replacement|Replacement of the tricusupid valve using Trisol System in a transcatheter approach
15744480|NCT04905004|Procedure|Canine retraction|Canines will be retracted using short elastomeric chains. Force applied to canines will be 150g.
15744481|NCT04904991|Procedure|Chan-Chuang qigong|"This study applied the Chan-Chuang qigong program, which was a modified form of the manual of Chan-Chuang qigong (Yeh et al., 2006), to tailor to patients with cognitive impairment. The Chan-Chuang qigong program included warmup prior to qigong practice, preparation for qigong practice, core qigong of four moves, and cool down after qigong practice.
~The movements should be repeated and maintained for 10 minutes per time, 3 time a day (Yeh et al., 2006), totally 90 minutes per week, for 3 months. The guideline booklet of Chan-Chuang qigong (Chen et al., 2019; Chuang, Yeh, & Chung, 2017) was modified and provided to the participants, which had major sections of introduction to qigong, preparation and precautions, practical procedures with description and photos, normal physical reactions from practicing core Chan-Chuang qigong, precautions of daily life, a confirmation sheet, and a checklist of qigong performance."
15744482|NCT04904978|Other|Blanx Black Toothpaste + Mouthwash|Use of Blanx Black Toothpaste twice a day per at least 2 minutes, followed by Blanx Black Mouthwash after brushing for at least 30 seconds.
15744483|NCT04904978|Other|Blanx Nordic Toothpaste|Use of Blanx Nordic Toothpaste twice a day per at least 2 minutes
15744484|NCT04904965|Drug|Propofol Group 1|Propofol 2.0 mg/kg/hr per 10 min
15744485|NCT04904965|Drug|Propofol Group 2|Propofol 4.0 mg/kg/hr per 10 min
15744486|NCT04904965|Drug|Propofol Group 3|Propofol 6.0 mg/kg/hr per 10 min
15744487|NCT04904965|Drug|Propofol Group 4|Propofol 8.0 mg/kg/hr per 10 min
15744488|NCT04904952|Drug|N-acetylcysteine tablet 600mg|N-acetylcysteine tablet 600mg/day and doubling weekly to reach a maximum dose of 2400mg/day (at week-3) for remaining 7 weeks along with SSRIs
15744489|NCT04904952|Drug|Placebo tablet 600mg|Placebo tablet 600mg/day and doubling weekly to reach a maximum dose of 2400mg/day (at week-3) for remaining 7 weeks along with SSRIs
15744490|NCT04904939|Procedure|Bronchoscopic mucosal biopsy|Endobronchial forceps biopsy using flexible bronchoscope
15744491|NCT04904913|Drug|IBI362|IBI362 administered subcutaneously (SC) once a week.
15744492|NCT04904913|Other|placebo|placebo administered subcutaneously (SC) once a week.
15744493|NCT04904887|Procedure|phacoemulsification|phacoemulsification with implantation of EYEHANCE IOL
15744494|NCT04904874|Device|intense pulsed light|treatment with 3 sessions of intense pulsed light, the second one after 2 weeks, the third one after 6 weeks
15744495|NCT04904861|Behavioral|Videoconference intervention group|A short face-to-face dyadic group workshop focused on increasing maternal sensitivity was adapted to be carried out virtually by videoconference. The intervention considers 4 sessions, with a weekly frequency, with a minimum of 3 and a maximum of 6 dyads per group led by a monitor (psychologist). The activities are protocolized in a manual and are designed to be carried out by the mother with the baby under one year of age. .
15744496|NCT04904861|Other|Control group|Psycho-educational intervention : They will receive brochures with information on parenting (once a week for 4 weeks) in addition to the usual care in their primary care center
15744497|NCT04904848|Other|Survey evaluation|examine the convergent validity and reliability of a Turkish version
15744498|NCT04904835|Diagnostic Test|Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays|All samples will be tested with both CE-marked HBV serological predicate assays (HBsAg, HBsAb, HBcT, HBc IgM, HBeAb, and/or HBeAg assays) and Access HBV serological assays (HBsAg, HBsAb, HBcT, HBc IgM, HBeAb, and/or HBeAg assays) according to respective Instructions For Use to determine non-reactive (NR), initially reactive (IR), repeatedly reactive (RR), or confirmed or not confirmed Positive.
15744499|NCT04904822|Procedure|Vaginal bisection|Uterine bisection vaginally by scalpel 24
15744500|NCT04904822|Procedure|Abdominal bisection|Uterine bisection by endokinfe
15744501|NCT04904809|Device|Perclose ProGlide Suture Mediated Closure System|The ProGlide and Prostyle SMC (when approved) in this study will be used for multiple access site closures in a single vein in the ablation procedure.
15744502|NCT04904796|Other|CIMT|CIMT : Constraint-Induced Movement Therapy (CIMT) is a deviation from traditional treatments, used to treat hemiplegia. Its aim is to stimulate the functional use of the affected limb and reverse the process developmental is disregard. In this method, the unaffected or less affected limb is restrained, so the person has to use the affected limb.
15744503|NCT04904796|Other|H-HABIT|H-HABIT : Hand-Arm Bimanual Intensive Therapy (HABIT) in children with hemiplegia is a new intervention developed at Columbia University. HABIT aims to improve the use and coordination of both arms in daily function. Unlike CIMT, HABIT focuses on improving the ability to perform bimanual activities. Participants will be monitored via webcam-based software (i.e. ZOOM) while they performed the activities in their own home.
15744504|NCT04904783|Radiation|Low dose radiotherapy|Patients in study group will receive LDRT to both lungs by two parallel opposed fields, antero-posterior (AP) and postero-anterior (PA) to deliver a midplane dose of 0.5 Gy in a single fraction. As this dose is very less, doses to the critical structures including heart and lungs would be very low. All the patients will be treated on Telecobalt unit (Theratronics Phoenix, Canada) and not on the linear accelerator to avoid risks to cancer patients on treatment with linear accelerator. CT based plan will not be undertaken for logistic issues and is also not felt to be mandatory for this LDRT. Dose computation would be carried out by manual dose calculation for the Telecobalt unit.
15744507|NCT04904757|Device|Contrast-enhanced spectral mammography (CESM)|CESM is a mammogram performed after the injection of IV contrast. CESM is used most often when additional information is needed after a standard mammogram. CESM has also been used to determine the extent of a known breast cancer, to screen patients at high risk for developing breast cancer due to a family history or positive cancer genes, and for women with dense breast tissue. Two images are taken almost at the same time during the exam, after the iodine based contrast injection is administered. The first image is comparable to a regular mammogram. The second image shows areas that take up the contrast (enhance) showing increased blood flow. Breast cancers often enhance with contrast due to a greater amount of blood vessels. Non-cancerous lesions can also have greater blood flow.
15744508|NCT04904744|Other|Low tailored message|2 low tailored text or phone message reminders that child is overdue for well child check visit
15744509|NCT04904744|Other|No message|No reminders are sent
15744510|NCT04904744|Other|Low tailored message plus COVID-19 vaccine message|2 low tailored text or phone message reminders that child is overdue for well child check visit and that COVID-19 vaccine is available
15744511|NCT04904731|Other|Prone position|Patients were assisted in NIV in supine position that was switched in prone position for clinical purpouse
15744512|NCT04904718|Device|DreaMed Advisor Pro|Advisor Pro software is a proprietary algorithm, designed to provide a comprehensive analysis of individual diabetes data consisting of glucose levels, insulin delivery history and meal consumption reported
15744513|NCT04904705|Other|The Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach|"The Cognitive Orientation to Daily Occupational Performance (CO-OP) Approach is a cognitive-based approach. This is a person-oriented, performance-solving problem-solving approach that enables strategy acquisition and guided exploration for the acquisition and learning of new skills.
~The main objectives of this approach are; define and transfer domain-specific strategies to other motor-based tasks to gain skills, learn problem-solving strategy (goal, plan, do, check) and adapt to other environments (such as home, school)."
15744514|NCT04904705|Other|Home Program|Home Program are activities that a participant can apply at home to improve their skills.
15744515|NCT04904692|Procedure|Blood draw|8x9mL EDTA tubes. In subjects treated with hydroxychloroquine treatment an extra EDTA tube (4mL) will be collected for the REVIVE substudy.
15744516|NCT04904692|Procedure|Bronchoalveolar lavage|Only in case of diagnostic or therapeutic indication.
15744517|NCT04904692|Procedure|SARS CoV-2 swabs|Nasopharyngeal, oropharyngeal and nasal swabs
15744518|NCT04904679|Device|Pars plana Vitrectomy with internal limiting membrane peeling|The vitrectomy technique using pars plana 23-gauge will be performed with removal of the ILM (when present adhered to the macula) and placement of an amniotic membrane plug or a internal limiting membrane flap in the macular hole, with a fluid-air exchange and a buffering gas infusion (C3F8 12, 5%). The amniotic membrane plug will be made with a dermatological punch with a diameter of 1.0 to 2mm depending on the size of the macular hole measured by the OCT, and will be positioned inside de macular hole with the chorionic side facing the RPE ( retinal pigmented epithelium) with a 23 gauge forceps. The chorionic side of the membrane is the sticky one. The internal limiting membrane flap will be created at the same time of peeling and will bem positioned in as inverted flap over and inside the macular hole with a 23 gauge ILM forceps. These technics will be helped with de use of a extra lighting sclerotomy.
15744519|NCT04904653|Device|Hemopatch|"HEMOPATCH Sealing Hemostat (HEMOPATCH) consists of a soft, thin, pliable, flexible pad of collagen derived from bovine dermis, coated with NHS-PEG (pentaerythritol polyethylene glycol ether tetra-succinimidyl glutarate).
~Due to its flexible structure, the application of HEMOPATCH to the site where hemostasis / sealing is desired is easily controlled. For differentiation, the non-coated side is marked with blue squares using a biocompatible colorant.
~HEMOPATCH is supplied in the following 3 sizes:
~HEMOPATCH 27 x 27 mm
~HEMOPATCH 45 x 45 mm
~HEMOPATCH 45 x 90 mm"
15744520|NCT04904653|Other|Control group|No sealant (liquid, gel or patch) + suction drain
15744521|NCT04904640|Device|Hip stem|In every hip (with appropriate CT scan), 3 different stem designs will be positioned using a 3D Ct based software for surgical pre-operative planning.
15744522|NCT04904614|Drug|Letermovir|Open label trial of the licensed drug, letermovir, in a population of heart transplant recipients for which it is not yet licensed
15744523|NCT04904601|Dietary Supplement|Kale supplement|Kale (blanched freeze-dried Kale) group1
15744524|NCT04904601|Dietary Supplement|Peas supplement|placebo (Blanched Freeze-dried Peas) group2
15744538|NCT04904575|Procedure|Erector spinae plane block|"Procedure : After installing the sleeping patient and identifying the surgical level by the surgeon, the anesthetist will perform the erector spinae plane block. The anesthetist performs an ultrasound to view the spine and erector muscles and identifies the transverse processes of the vertebra involved in the surgery. Once the location has been made, the anesthetist injects the anesthetic product under ultrasound control between the erector muscle of the spine and its anterior fascia, the trajectory of the needle being thus visualized throughout the procedure. The anesthetist bilaterally injects 3ml/kg of solution with a maximum of 30ml injected.
~Drug : Levobupivacaïne 2,5mg/ml."
15744539|NCT04904575|Procedure|Erector spinae plane block|"Procedure : After installing the sleeping patient and identifying the surgical level by the surgeon, the anesthetist will perform the erector spinae plane block. The anesthetist performs an ultrasound to view the spine and erector muscles and identifies the transverse processes of the vertebra involved in the surgery. Once the location has been made, the anesthetist injects the anesthetic product under ultrasound control between the erector muscle of the spine and its anterior fascia, the trajectory of the needle being thus visualized throughout the procedure. The anesthetist bilaterally injects 3ml/kg of solution with a maximum of 30ml injected.
~Drug : NaCL 0,9%."
15744540|NCT04904562|Drug|Angiotensin II|Angiotensin II started at 5 ng/kg/min and titrated in 5-10 ng/kg/min increments every 5 minutes up to 80ng/kg/min to achieve target arterial pressure (MAP)
15744541|NCT04904562|Drug|Placebo|Placebo
15744542|NCT04904549|Biological|SARS-CoV-2 adjuvanted recombinant protein vaccine (monovalent)|Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection
15744543|NCT04904549|Biological|SARS-CoV-2 adjuvanted recombinant protein vaccine (bivalent)|Pharmaceutical form: emulsion for injection. Route of administration: intramuscular injection.
15744544|NCT04904549|Biological|Placebo|Pharmaceutical form: liquid. Route of administration: intramuscular administration.
15744545|NCT04904536|Drug|Atorvastatin|40mg atorvastatin + standard care daily for 18 months.Atorvastatin 40mg has TGA approval for general marketing for the treatment of hypercholesterolaemia and cardiovascular prevention under a number of manufacturer names.The study medication selected will be the atorvastatin 40mg (Apotex) which is scored, and allows down-titration to 20mg should a participant develop symptoms.The study medication will be packaged, labelled and dispensed directly to particpants by the Syntro Health pharmacy in Australia. A comparable atorvastatin 40mg is being sourced in Chile, and will be dispensed from the pharmacy of the Clínica Alemana de Santiago.
15744546|NCT04904536|Other|Standard Care|Standard care for neurological symptoms as a result of COVID-19 infection.
15744547|NCT04904523|Diagnostic Test|Diagnostic Test:Blood test|Drop of blood for RNA and metabolic analysis
15744548|NCT04904510|Device|Rapid antigen testing and offsite PCR testing|Positive INDICAID™ COVID-19 Rapid Antigen Test results would trigger expediting PCR testing at an offsite lab for outbreak testing.
15744549|NCT04904510|Device|Rapid antigen testing and onsite PCR testing|Positive INDICAID™ COVID-19 Rapid Antigen Test results would trigger expediting PCR testing at an onsite rapid nucleic acid amplification test.
15744550|NCT04904497|Behavioral|Early Occupational Therapy|"Occupational therapists will implement the following activities:
~Polysensory stimulation: external stimulation for increasing the level of alertness. It will be implemented with SAS 2 one session each 24 h.
~Cognitive stimulation: bundle of exercises for activating mental functions, i.e: alertness, visual perception, memory, calculus, problem solving, praxis, language. Patients with SAS 3, 4 and 5. In SAS <2, 6> environmental orientation will be considered
~Basic activities of daily living (BADLs): promotion of independence that initially practice hygiene, personal grooming. Patients with SAS 3, 4 and 5
~Motor function Stimulation: exercises to keep the patient's upper extremities active and functional. Patients with SAS with 3,4 and 5. Patients with SAS 1 and 2 will use adaptations to prevent edema and bedsores on vulnerable body areas
~Education: trained family members and health staff about the intervention process"
15744551|NCT04904484|Device|iZephyr hood|Assessment of an aerosol containment device
15744554|NCT04904458|Other|"Experimental group (enfacement illusion)"|Virtual reality enfacement illusion exposure
15744555|NCT04904458|Other|Control Group (Pleasant virtual environment exposure)|Pleasant virtual environment exposure
15744556|NCT04904432|Genetic|PLIN1 gene sequencing|One supplementary blood sample will be taken (compare to classical ACS treatment and follow up) to realize genetic analyse of PLIN1 gene, looking for mutations
15744557|NCT04904419|Diagnostic Test|Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600e|Intraoperative Rapid Detection mutation of IDH, TERT and BRAF v600e
15744558|NCT04904406|Drug|Dolutegravir / Lamivudine Oral Tablet|Discontinuing abacavir by switching from three-drug regimen with dolutegravir/abacavir/lamivudine to two-drug regimen with dolutegravir/lamivudine
15744559|NCT04904393|Device|Implant of the device for Cardiac Contractility Modulation (CCM) Therapy|The intervention is an implant of CCM therapy devices and it is similar to conventional dual chamber cardiac devices with only difference of to insert n 2 leads fixed in right ventricular septum
15744560|NCT04904380|Other|Active peer learning|HMS, HBS and peer learning in combination with AIR and PRISMS
15744561|NCT04904367|Procedure|Deep tissue massage|The amount of pressure during the massage was adjusted by the physiotherapist with reference to muscle tissue palpation in the patients. During the massage, olecranon, pisiform bone protrusion, metacarpophalangeal and proximal interphalangeal joint faces forearm, wrist and fingers were used during the massage to reach deep tissue. As a massage technique, compression and stretching techniques are used in combination.
15744562|NCT04904367|Procedure|Conventional physiotherapy|For 4 weeks 20 session, this group were applied hot pack with 20 minutes of conventional TENS to back and neck region, followed by 4 minutes of ultrasound at a frequency of 3 MHz and at a dosage of 1 w / cm2.
15744564|NCT04904341|Drug|Cerebrolysin|neuroprotection treatment
15744565|NCT04904328|Device|Lumishade® Active Lens|"Migraine episodes are often triggered or exacerbated by environmental factors, particularly light. Active lens has been designed by blocking particular range of wavelength and hypothetically alleviate symptoms of migraine and thus either treat or prevent migraine headaches from occurring.
~(Note, we are reluctant to write any further information around the devices on this public record while the study is active to ensure we maintain the blind of the trial.)"
15744566|NCT04904328|Device|Lumishade® Sham Lens|"Lumishade® Sham lens has been designed as inactive and not blocking particular range of wavelength. Thus, it will not alleviate or prevent symptoms of migraine.
~(Note, we are reluctant to write any further information around the devices on this public record while the study is active to ensure we maintain the blind of the trial.)"
15744567|NCT04904315|Other|Mindera Kit|The entire duration of the study, including the screening period, will be approximately 16 weeks. Mindera Kit will be applied with applicator and left on the skin for 5 minutes, and once removed, the investigational product (IP) will be placed in a buffer solution, sealed, labeled and sent to Mindera for processing.
15744568|NCT04904302|Biological|Nivolumab|Given IV
15744569|NCT04904302|Other|Quality-of-Life Assessment|Ancillary studies
15744570|NCT04904302|Other|Questionnaire Administration|Ancillary studies
15744571|NCT04904302|Drug|Sitravatinib|Given PO
15744572|NCT04904289|Other|All intervention of real world|We analyzed all data we can obtain from our databases
15744573|NCT04904276|Drug|Fostamatinib|Fostamatinib disodium
15744574|NCT04904250|Device|Emboshield|a distall occlusion Emboshield NAV6 will be used as the embolism protection device during CAS
15744575|NCT04904250|Device|Spider|a distal SpiderFX will be used as the embolism protection device during CAS
15744576|NCT04904237|Drug|Aza-Ven-allo-HSCT|aaa-ven treatment followed by allo-HCTS with reduced toxicity conditioning (RTC) of Fludarabine, Busulifan and Melphalan
15744577|NCT04904224|Device|Panintestinal video capsule endoscopy|Performing a video capsule endoscopy using the Pill Cam Crohn's capsule from Medtronic
15744578|NCT04904224|Device|Colonoscopy|Performing a standard colonoscopy using the colonoscope available in the study center
15744579|NCT04904211|Other|Home-based chemotherapy|To investigate the feasibility and safety of home-based intensive chemotherapy in patients with newly diagnosed acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS). Furthermore, we examined the quality of life (QOL) and psychological wellbeing while receiving induction and consolidation chemotherapy at home.
15744580|NCT04904198|Behavioral|Care Management Intervention for non-cardiac chest pain|Multicomponent eight-week care management intervention involving a consultation visit with a cardiologist and nurse. Recommendations from the consultation visit are conveyed to the primary care physician. Following the visit, the participant has eight weekly phone calls with a nurse to provide support, introduce therapeutic principals, and assess symptoms. The study nurse is supervised by a psychiatrist.
15744581|NCT04904185|Drug|Cyclophosphamide|Cyclophosphamide 500 mg/m2 is administered i.v. on day -4, -3 and -2
15744582|NCT04904185|Drug|Fludarabine Phosphate|Fludarabine Phosphate 30 mg/m2 is administered on day -4 and -3
15744583|NCT04904185|Biological|Multiple Antigen Specific Endogenously derived T cells|Antigen specific, ex vivo expanded T cells derived from peripheral blood T cells
15744584|NCT04904185|Drug|Pembrolizumab|Pembrolizumab 2 mg/kg is administered on day -1 and on day 21. The medicine is administered over 30 minutes
15744585|NCT04904172|Device|Masimo O3 Regional Oximetry|wo electrodes will be attached to the forehead area and connected to the Near Infrared Spectroscopy device after the consent of the patients who apply to Ege University Hospital Emergency Service with acute ischemic stroke and who are planned to have intravenous thrombolytic and / or endovascular thrombectomy treatment or treatments, and / or their caregivers.
15744586|NCT04904159|Procedure|Thyroidectomy|total thyroidectomy
15744587|NCT04904159|Procedure|Lobectomy|Lobectomy
15744588|NCT04904146|Diagnostic Test|Blood tests and testing of analysis of the lymphoma microenvironment in skin, skin barrier and skin microbiology profile.|The study aims to perform systematic translational sampling of each patient from study start until end-of-study, or at longest for a three year period for each patient. Treatment will be performed according to clinical routine.
15744589|NCT04904133|Other|Low/No Calorie Sweeteners|LNCS powdered and then dissolved in water.
15744590|NCT04904133|Other|Placebo Group|Water
15744591|NCT04904120|Drug|[203Pb]VMT01|Diagnostic imaging radiopharmaceutical; by intravenous infusion
15744592|NCT04904120|Drug|[68Ga]VMT02|Diagnostic imaging radiopharmaceutical; by intravenous infusion
15744593|NCT04904107|Diagnostic Test|modified HEART score (including POC hs cTnI analysis)|"The modified HEART score was developed in 2007 and has been validated to stratify the risk of short-term adverse cardiac events in patients with chest pain at the ED. Negative predictive value (NPV) of the modified HEART score for ACS as well as positive predictive value (PPV) for major adverse cardiac events (MACE) within 6 weeks after presentation is high.
~The modified HEART score is an acronym for history, ECG, age, risk factors and troponin at arrival.The components can be rated 0,1 or 2 points each and result in a total score between 0 and 10."
15744594|NCT04904107|Other|Standard care and triage according to the local (EMT)protocol.|Standard care and triage of chest pain patients according to the local (EMT)protocol.
15774937|NCT04655391|Drug|Ivosidenib|Given PO
15744595|NCT04904094|Other|Casting of the lower limb and homebased stretching exercise program.|Lower leg casting in combination with removable upper leg casts for approximately 2 weeks and stretching exercises during casting and 4 weeks after casting.
15744596|NCT04904081|Drug|Indocyanine green|The ICG group will involve the patient receiving standard care for either HD or ARM, in addition to 1.25mg (maximum dose less than 2mg/kg body weight) of ICG intraoperatively, administered intravenously. ICG will be administered by a member of the anesthesia team when directed by the surgeon (research team member).
15744597|NCT04904055|Other|Value-based Formulary|Prescription drug formulary tiers informed by estimated value
15744598|NCT04904042|Device|Use of plasma of neutral argon|"Evaluation of the mesentery or peritoneum area infiltrated by miliary implants that is going to be treated. Determination of the PCI. Collection of several samples of the mesenteric peritoneum or parietal peritoneum with tumor involvement (implants between 1-2.5mm of diameter).
~It will established a matrix which will be divided into 12 quadrants where the tissue with implants will be placed and it will be treated according to specific power (80-100%), and for an action time of 2-4 seconds or until macroscopic tumor destruction. For each power, application of Plasmajet at 1, 2 and 3 cm from the target tumor tissue.
~The in-vivo effect will be evaluated with the use of ball-tip in terms of damage to the serosa or vascularization of the mesentery."
15744599|NCT04904029|Other|Digital Assessment Routing Tool [DART]|"DART is a first contact web-based and mobile health system that uses clinical algorithms to triage patients and recommend management pathways. Participants complete an online web-based questionnaire that follows a clinical reasoning process commonly observed in face-to-face physiotherapy consultations. Based on the participant's answers, the clinical algorithm generates sets of questions, leading up to a triage disposition with recommended management pathway. The triage outcomes with management pathways are classified;
~Medical care
~A&E referral
~Urgent GP
~Routine GP
~Consultant review
~Physiotherapy care
~Post-fracture or surgery physiotherapy
~Physiotherapy referral
~Physiotherapy referral plus psychosocial support
~Self-management
~Self-management with SOS
~Continue self-management advice"
15744600|NCT04904029|Other|Physiotherapy-led remote triage (usual care)|Participants will receive usual physiotherapy-led remote triage services by a registered health care professional. This service is either a telephone or video consult and includes any diagnostic procedure (e.g. patient history, remote assessments) and treatment, such as management advise or home-based exercise therapy. Participants may seek help elsewhere or opt-out the study at any point, which will not affect their usual physiotherapy-led remote care
15744601|NCT04904016|Device|FlowOx™|The FlowOx™ system generates a negative oscillating pressure which cause rapid fluctuations in blood flow in the leg and foot.
15744602|NCT04904003|Other|Rehabilitation Intervention|Strength, flexibility, endurance, balance, mobility, (self-efficacy)
15744603|NCT04903990|Other|Blood sample|As part of the treatment, 2 EDTA tubes of 10mL will be taken during a scheduled venipuncture as part of the preoperative assessment.
15744604|NCT04903977|Diagnostic Test|Laboratory tests: blood and faeces tests|To be performed at V2
15744605|NCT04903977|Diagnostic Test|Gynaecological and proctological examinations|To be performed at V1 (Examination with a gynaecological speculum, Bimanual examination, Rectal examination, and Anoscopy)
15744606|NCT04903977|Diagnostic Test|3-D Endoanal Ultrasound|To be performed at V1 (as a reference and for group assignment)
15744607|NCT04903977|Device|ONIRY measurement|To be performed at V2 (the electrical impedance of anal sphincter muscles will be measured)
15744608|NCT04903977|Diagnostic Test|High-resolution anorectal manometry|To be performed at V3
15744609|NCT04903977|Diagnostic Test|ECG|To be performed at V1 and V2 (for safety reasons)
15744610|NCT04903964|Other|family-centered nutrition education|There is a training program prepared by the researcher to increase the nutritional knowledge of mothers with children aged 0-3. The definition and importance of nutrition in the session, respectively, adequate and balanced nutrition, insufficient and unbalanced nutrition damages, grouping of nutrients, feeding 0--6 months old baby, feeding premature baby, breastfeeding, situations to be considered while breastfeeding, starting additional foods, 9-12 monthly baby nutrition, 1-3 years old child nutrition and nutritional nutrition support.
15744611|NCT04903951|Device|Adaptive Servoventilation (ASV) therapy|Patients assigned to the active group will receive ventilatory support with ASV (DreamStation BiPAP autoSV®) during diurnal and nocturnal sleep, from study randomization until clinically indicated
15744612|NCT04903951|Other|Best medical treatment|Best medical treatment for stroke, including rehabilitation
15744613|NCT04903938|Behavioral|Primary And Secondary Abilities Among The Individuals With Antisocial Personality Disorder Within The Scope Of Positive Psychotherapy: Their Relationship With Criminal Behaviors, Aggression And Anger|Participants will be given scales with validity and reliability studies in Turkish.
15744614|NCT04903925|Procedure|Impacted tooth extraction|All patients will undergo a surgical tooth extraction
15744615|NCT04903912|Diagnostic Test|Vascular ultrasound or other imaging methods according to current guidelines|Peripheral vascular ultrasound / ankle/brachial index / CT angiography / MR angiography / angiography
15744616|NCT04903912|Diagnostic Test|Laboratory tests|Metabolic profile and platelet reactivity
15744617|NCT04903912|Drug|Medical treatment according to current guidelines|Antithrombotic drugs, lipid-lowering drugs, antihypertensive drugs, and pharmacotherapy to increase walking capacity according to current guidelines
15744618|NCT04903912|Procedure|Endovascular od surgical peripheral revascularizations|Endovascular od surgical peripheral revascularizations according to current guidelines
15744619|NCT04903899|Combination Product|177Lu-DOTATATE|A weight-based activity of 200 MBq kg-1 will be used for the first dose. The activity of the second dose will be calculated based on whole body activity scans as well as SPECT CT scans to determine the absorbed kidney dose. The aim is to administer 177Lu-DOTATATE corresponding to a whole-body dose of 1,2 Gy, with a cumulative whole-body dose of about 2,4 Gy over two courses, and not exceeding a cumulative renal dose of 23 Gy, in order to avoid renal toxicity.
15744620|NCT04903886|Other|observational|observational
15744621|NCT04903873|Drug|EU101|EU101 will be administered via intravenous infusion.
15744622|NCT04903860|Device|total hip replacement with single use ancillary|Comparison of the use of conventional ancillary reaming and single-use ancillary reaming material in total hip replacement
15744623|NCT04903860|Device|total hip replacement with conventional ancillary|Comparison of the use of conventional ancillary reaming and single-use ancillary reaming material in total hip replacement
15744624|NCT04903847|Drug|Dolutegravir/Lamivudine 50 MG-300 MG Oral Tablet [DOVATO]|Two-drug therapy
15744625|NCT04903847|Drug|Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate 100 MG-300 MG-300 MG Oral Tablet [DELSTRIGO]|Three-drug therapy
15744626|NCT04903834|Diagnostic Test|Soton hyperinflammation score|Score for hyperinflammation defined by blood parameters and other physiological measurements
15744627|NCT04903834|Diagnostic Test|HScore|Score for secondary haemophagocytic lymphohistiocytosis validated in prior publications
15744629|NCT04903808|Drug|Allium Sativum Oil|Garlic oil Captain Company (CAP-PHARM)
15744630|NCT04903808|Drug|Mineral Tri-Oxide Aggregate|ProRoot MTA, Dentsply
15744631|NCT04903795|Drug|hEGFRvIII-CD3 (BRiTE)|Bispecific T cell engager possessing one effector binding arm specific for the epsilon subunit of CD3 (a signaling molecule complex associated with the T cell receptor on T cells) while the opposing target-binding arm is directed against the hEGFRvIII epitope that is differentially expressed on the surface of tumor cells
15744632|NCT04903795|Biological|Activated Cell Therapy|Autologous activated human T cells obtained via leukapheresis
15744633|NCT04903782|Diagnostic Test|Family-based whole genome sequencing|"Germline whole-genome family-based sequencing and variant identification.
~Multidisciplinary Meeting case discussion.
~Recommendation of referral to a Cancer Genetics Clinic for further investigation, follow up and/or genetic counselling.
~Psychosocial study to analyse the impact of germline sequencing on families."
15744634|NCT04903769|Behavioral|Stress Management and Resiliency Training Program for Parkinson's Disease (SMART-PD)|SMART-PD is a manualized intervention that teaches cognitive-behavioral techniques and relaxation skills to help participants learn to elicit the relaxation response, alter cognitive appraisals, improve healthy lifestyle behaviors (i.e., sleep, nutrition, physical activity) and access social support.
15744635|NCT04903743|Drug|bupivacaine|group B received 28ml of 0.25% bupivacaine and 2ml normal saline
15744636|NCT04903743|Drug|magnesium sulfate|group BM received 28 ml of 0.25% bupivacaine and 2 ml magnesium sulfate 10%.
15744637|NCT04903730|Drug|AER-901 Solution for Nebulization|"Part A: participants will be enrolled into 1 of up to 5 sequential cohorts (Cohorts A1 to A5). Inhaled AER-901 doses of 5 mg, 10 mg, 20 mg, 40 mg, and 80 mg are planned. Each cohort will consist of 8 participants (6 participants receiving inhaled AER-901 and 2 participants receiving inhaled placebo).
~Part B: participants will be enrolled into 1 of up to 4 cohorts (Cohorts B1 to B4).
~Each cohort will consist of 8 participants (6 participants receiving AER 901 and 2 participants receiving placebo)."
15744638|NCT04903730|Drug|Placebo|0.45% sterile saline for injection delivered via the FOX MOBILE device.
15744639|NCT04903717|Behavioral|Best Practice Alert|Providers randomized to the intervention arm will have a best practice alert appear for each of their eligible patients upon opening of the order entry screen in the patient's medical record. This alert informs the provider to the presence of HFrEF and absence of MRA prescription, notes the patient's current LVEF, and notes the most recent labs, including NT-ProBNP, potassium, and creatinine. Providers will also have access to a link to best available guideline recommended information regarding use of MRAs and a link to both an order set for prescribing an MRA and an alternate order set with option for potassium monitoring should hyperkalemia be a concern. If a patient is hyperkalemic (i.e. K ≥ 5 mEq/L), a link to an order set for prescribing a potassium binder will be provided instead. If a provider feels that the recommended therapy is not indicated for a particular patient, he/she can select an available reason from the list provided within the alert.
15744640|NCT04903704|Diagnostic Test|1 Minute Sit to Stand Test|Participants are asked to stand repeatedly from a chair for one minute without the use of their arms for support. The number of completed repetitions is counted.
15744641|NCT04903691|Behavioral|Cardiac Exercise Program|Participants who enrolled in cardiac exercise program
15744642|NCT04903678|Drug|Melphalan|Melphalan is performed for intrathecal chemotherapy
15744643|NCT04903665|Device|Multi-cancer early detection test|Blood collection and multi-cancer early detection testing
15744644|NCT04903652|Drug|Pyrotinib Maleate|Pyrotinib p.o. 400 mg once daily
15744645|NCT04903652|Drug|Vinorelbine|Vinorelbine p.o. 40 mg once every other day
15744646|NCT04903639|Diagnostic Test|sleep study|The polysomnography consists of electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), electromyogram (EMG), pulse oximetry, thoracic and abdominal straps, body posture sensor, nasal thermistor and nasal cannula to assess respiratory flow and pressure and bipolar channel limb movements (tibialis anterior). Electrodes and sensors were attached to patients by sleep physiologist. Data collection was obtained following signal perception by preprocessed computer (DOMINO Software, ver. 2.6.0; SOMNO Medics GmbH).
15744648|NCT04903613|Drug|Ligelizumab|Ligelizumab 120 mg s.c every 4 weeks
15744649|NCT04903600|Dietary Supplement|Probiotics fruit vegetable fiber powder product|Eat 16 g for once, and twice a day
15744650|NCT04903600|Dietary Supplement|Placebo|Eat 16 g for once, and twice a day
15744651|NCT04903587|Device|Ultrasonography and MRI|Abdominal Ultrasonography and axial MRI
15744652|NCT04903574|Behavioral|NEAT!2 sedentary behavior app|This is a smartphone app that reminds you to stand up if you've been sitting for at least 30 minutes.
15744653|NCT04903574|Other|Pregnancy smartphone app|This is a commercially available general pregnancy smartphone app
15744654|NCT04903561|Device|ColliPee|The GP will hand over the self-sampling kit to the women, after obtaining informed consent, and the women then takes the self sample at home or in the doctor's office (predefined), according to the respective users manual.
15744655|NCT04903548|Procedure|SIRT with Y-90 resin microspheres|Selective internal radiation therapy (SIRT) with Y-90 resin microspheres (Y-90 resin SIRT) is an intra-arterial, catheter-based locoregional therapy that has been used to treat patients with unresectable HCC
15744720|NCT04903028|Device|Sham rTMS|Two electrodes on the scalp will be connected to transcutaneous electrical nerve stimulation.
15744721|NCT04903028|Device|Active rTMS 10 Hz DLPFC|10 Hz repetitive transcranial magnetic stimulation (rTMS) will be delivered over left dorsolateral prefrontal cortex (DLPFC).
15744722|NCT04903028|Device|Active rTMS 1 Hz mOFC|1 Hz repetitive transcranial magnetic stimulation (rTMS) will be delivered over left medial orbitofrontal cortex (mOFC).
15744656|NCT04903535|Device|Alonefire SV003 10W 365nm UV Flashlight|Investigator will use a Nitric Oxide Analyzer while attached to a small suction port on the subject's ear lobe to be tested for Nitric Oxide. After getting the baseline assay, the investigator will shine a low-intensity UV Flashlight (Alonefire SV003 10W 365nm UV Flashlight) at the ear lobe for 10 seconds, repeated three times at 20 second intervals, to determine if there is photobleaching. Then the assay will then be performed on the opposite ear lobe. Fifteen minutes after the third UV flashlight exposure, the investigator will collect air from the subject's ear during photolysis into a 20mL glass syringe (once from each ear). Fifteen minutes after the third UV flashlight exposure, the investigator will collect air from the subject's ear during photolysis into a 20mL glass syringe (once from each ear). The subject and the investigator will wear UV goggles during the experiment.
15744657|NCT04903522|Behavioral|Baroque music listening|"Patients will listen to a 30-minute musical path of baroque pieces. Before and after this, anxiety, depression and consciousness fluidity will be evaluated thanks to different questionnaires"
15744658|NCT04903509|Drug|BI 1820237|BI 1820237
15744659|NCT04903509|Drug|Placebo|Placebo
15744660|NCT04903509|Drug|Saxenda®|Saxenda®
15744661|NCT04903509|Drug|Paracetamol-ratiopharm®|Paracetamol-ratiopharm®
15744662|NCT04903483|Other|bispectral index monitoring|intraoperative single-channel electroencephalography monitoring of the depth of anesthesia
15744663|NCT04903470|Drug|Bisacodyl|Biscodyl a stimulant laxative is expected to stimulate rectal contraction and enhance expulsion of Fecobionics
15744664|NCT04903470|Drug|Atropin|Atropin is an anticholinergic drug that is expected to inhibit rectal contractions and make defecation more difficult.
15744665|NCT04903457|Device|Transcranial Direct Current Stimulation|Transcranial direct current stimulation is a form of noninvasive neuromodulation that uses constant and low direct current delivered via electrodes on the scalp.
15744666|NCT04903457|Behavioral|Motor learning|Sequential finger tapping task training is applied to stroke patients.
15744667|NCT04903444|Device|Artificial intelligence assistant system|The endoscopists in the experimental group will be assisted by AI system, which can instruct the direction of guide wire and the position of stent placement in real time. The system is an non-invasive AI system .
15744668|NCT04903431|Behavioral|Crisis Response Planning for Suicide Risk|Crisis Response Planning is focused on creating personalized set of steps for individuals to follow in case of a crisis and includes individuals' personal warning signs of distress, behavioral coping strategies, reasons for living, social supports to contact, and contact information for professional services, including emergency services. Personalization of the Crisis Response Plan is encouraged, and individuals are instructed to handwrite each step of the Crisis Response Plan on an index card to review.
15744669|NCT04903418|Device|CBCT software|"Retrospective Data Analysis will be performed after the CBCT images are pooled from the computer database.
~All the CBCT examinations will be obtained for patients who were scanned using CBCT Software (Planmeca Romexis® Viewer software).
~CBCT images will be analysed in different planes."
15744670|NCT04903405|Other|No intervention|No intervention is involved in this study
15744671|NCT04903392|Other|Backward Walking Training|"The training speed will start at the basic walking speed and will increase by 5% of the starting speed each week. The training, which will take 30 minutes, will be as follows: 5 minutes forward walking (warm-up phase), 20 minutes backward walking (intervention phase) and 5 minutes forward (cooling phase).
~-three times a week for six weeks"
15744672|NCT04903392|Other|Forward Walking Training|"The training speed will start at the basic walking speed and will increase by 5% of the starting speed each week. It will be in the form of walking forward for 30 minutes.
~-three times a week for six weeks"
15744673|NCT04903379|Other|Education|An explanation of contemporary pain science and a description of effective treatment strategies used by people with a history of persistent pain.
15744674|NCT04903366|Drug|Timolol Maleate|timolol maleate 0.5% gel-forming solution
15744675|NCT04903353|Drug|Comparison of Risperidone and Aripiprazole|Comparing two FDA approved medications for treatment of irritability in autism
15744676|NCT04903340|Procedure|PET/CT Exam|PET/CT image processing application of reconstruction parameters: scan time, respiratory gating, Q-clear
15744677|NCT04903327|Biological|COVI-MSC|COVI-MSC are allogeneic culture-expanded adipose-derived mesenchymal stem cells
15744678|NCT04903327|Drug|Placebo|Excipient solution
15744679|NCT04903314|Drug|Xcopri|Xcopri will be administered orally not to exceed 400mg/day adult equivalent
15744680|NCT04903301|Procedure|Contoura Vision LASIK|Topography-Guided LASIK using Phorcides Analytic Software
15744681|NCT04903288|Genetic|Eladocagene Exuparvovec|Four 0.08 milliliters (mL) infusions at a dose of 0.45×10^11 vg and a volume of 80 microliters (μl) per site to 4 sites (2 per putamen), for the total dose of 1.8×10^11 vg and a total volume of 320 μl per participant.
15744682|NCT04903275|Procedure|Topical fluoride application and Laser irradiation|Topical fluoride varnish application (Clinpro™ White Varnish 5% Sodium Fluoride, 3M ESPE, USA) of the vestibular surfaces of the left maxillary anterior teeth followed by laser irradiation with CO2-laser (Ultra Dream Pulse, DS_40U, Daeshin Enterprise, Seoul, South Korea), emission wavelength 10,600 nm, time on-100 μs, time off-40 ms; average power-0.73 W; peak power-292.73 W; speed of movement-2 mm/s; energy density with movements-5 J/cm2; tip-to-tissue distance-20 mm; tip diameter 700 μm; irradiation time-30 s.
15744683|NCT04903275|Procedure|Topical fluoride application|Topical fluoride varnish application (Clinpro™ White Varnish 5% Sodium Fluoride, 3M ESPE, USA) of the vestibular surfaces of the left maxillary anterior teeth
15744684|NCT04903262|Procedure|Ultraprotective ventilation with Extracorporeal CO2 removal|HLS5.0 Cardiohelp® (Getinge Cardiopulmonary Care, Rastatt, Germany): 1.3 m² polymethylpentene hollow fiber membrane oxygenator. The extracorporeal blood flow is in the range of 1000 to 1500 mL/min. Sweep gas (air or oxygen) is drawn through the hollow fibers by a vacuum pump, creating a diffusion gradient for gas exchange across the membrane.
15744723|NCT04903015|Diagnostic Test|MRI|"The following sequences of the MRI will be acquired during the inclusion visit:
~3D T1 gradient echo (GRE): anatomy; registration; cerebral, white matter, and grey matter volumetry; and cortical thickness;
~multiecho 3D T2 GRE: quantitative susceptibility mapping (QSM), iron overload quantification;
~continuous arterial spin labeling (ASL) 3D: cerebral perfusion;
~resting-state fMRI: functional connectivity;
~64-direction DTI (b=1000 and 2500): alterations in white matter and its microstructure, anatomic connectivity;
~monovoxel spectroscopy of the mesencephalus with short echo time (TE)."
15744685|NCT04903249|Behavioral|Core Exercise Promotion Intervention|"Participants are instructed to increase weekly time spent exercising to >90 minutes over 12 weeks. Exercise will be defined as activities that use large muscle groups, increase heart rate and breathing rate, and are performed intentionally for the purpose of exercise (as opposed to physical activities of daily living, e.g., housework). Participants complete a videoconferencing visit with the study team and are given task and safety related information pertaining to exercise for survivors of cancer. Participants engage in exercise-related goal-setting and action planning and are provided activity trackers to monitor their activity levels over the 12-week study period."
15744687|NCT04903210|Dietary Supplement|Nicotinamide mononucleotide supplied as 400mg capsule|NMN10000 WRIGHT LIFE® + lifestyle modification NMN10000 WRIGHT LIFE®: 800mg, qd, for two months. Lifestyle modification: intake 1400-1600 kcal/day: 54% carbohydrates, 24% proteins, 22% lipids, 108 mg cholesterol, 35 g fiber; avoid smoking and alcohol consumption; performing aerobic activity 4 days per week such as 45 min on a stationary bicycle.
15744688|NCT04903210|Behavioral|Lifestyle modification|Lifestyle modification: intake 1400-1600 kcal/day: 54% carbohydrates, 24% proteins, 22% lipids, 108 mg cholesterol, 35 g fiber; avoid smoking and alcohol consumption; performing aerobic activity 4 days per week such as 45 min on a stationary bicycle.
15744689|NCT04903197|Drug|VAY736|VAY736 is a fully human IgG1 monoclonal antibody (mAb) which targets the B cell activating factor receptor (BAFF-R) expressed on the surface of differentiated B cells and modulates their function.
15744690|NCT04903197|Drug|lenalidomide|Immune-modulatory agent that enhances activation of NK cells.
15744691|NCT04903184|Biological|RUTI® vaccine|Each dose of the RUTI® vaccine contains 25 µg of fragmented, purified and liposomed heat-inactivated Mycobacterium tuberculosis bacilli in a total volum of 0,3mL.
15744692|NCT04903184|Biological|Placebo|Physiological serum, 0.9% NaCl, will be used as a placebo.
15744693|NCT04903171|Other|INCENTIVE VISITING A GARDEN : ENRICHED OR CONVENTIONAL SENSORY GARDEN|Carers invites every the participants of group 2 and 3 visiting their respective gardens (enriched or conventional sensory garden)
15744694|NCT04903158|Drug|test SHR3680 tablets|Subjects receiving a single oral dose of SHR3680 tablets with 240mg (80mg*3)
15744695|NCT04903158|Drug|reference SHR3680 tablets|subjects receiving a single oral dose of SHR3680 tablets with 240mg (100mg*2+20mg*2).
15744696|NCT04903145|Diagnostic Test|REOM|To compare data generated by the REOM device with data from the tremoflo C-100 device
15744697|NCT04903119|Drug|Nilotinib 100mg|Patients will begin dabrafenib (150mg PO BID) and trametinib (2mg PO once daily) on day one and will continue for 28 days. After 7 days, nilotinib will be added at 100mg PO BID and will continue for 21 days. For each subsequent cycle, nilotinib will be given for 28 days.
15744698|NCT04903119|Drug|Nilotinib 200mg|Patients will begin dabrafenib (150mg PO BID) and trametinib (2mg PO once daily) on day one and will continue for 28 days. After 7 days, nilotinib will be added at 200mg PO BID and will continue for 21 days. For each subsequent cycle, nilotinib will be given for 28 days.
15744699|NCT04903119|Drug|Nilotinib 300mg|Patients will begin dabrafenib (150mg PO BID) and trametinib (2mg PO once daily) on day one and will continue for 28 days. After 7 days, nilotinib will be added at 300mg PO BID and will continue for 21 days. For each subsequent cycle, nilotinib will be given for 28 days.
15744700|NCT04903119|Drug|Nilotinib 400mg|Patients will begin dabrafenib (150mg PO BID) and trametinib (2mg PO once daily) on day one and will continue for 28 days. After 7 days, nilotinib will be added at 400mg PO BID and will continue for 21 days. For each subsequent cycle, nilotinib will be given for 28 days.
15744701|NCT04903119|Drug|Dabrafenib|All patients will begin dabrafenib (150mg PO BID) on day one and will continue for 28 days.
15744702|NCT04903119|Drug|Trametinib|All patients will begin trametinib (2mg PO once daily) on day one and will continue for 28 days.
15744703|NCT04903106|Device|FAST-FIX FLEX Meniscal Repair System|Standard of care surgery in which the meniscus is repaired using FAST-FIX FLEX device.
15744704|NCT04903106|Device|FAST-FIX FLEX Meniscal Repair System|Standard of care surgery in which the FASTFIX FLEX device is used during the meniscal allograft transplantation procedure.
15744705|NCT04903093|Drug|Abrocitinib tablet|Single dose of abrocitinib 200 mg tablet will be administered after an overnight fast of at least 10 hours.
15744706|NCT04903093|Drug|Abrocitinib Suspension F1|Single dose of abrocitinib 200 mg oral suspension formulation 1 will be administered after an overnight fast of at least 10 hours.
15744707|NCT04903093|Drug|Abrocitinib Suspension F2|Single dose of abrocitinib 200 mg oral suspension formulation 2 will be administered after an overnight fast of at least 10 hours.
15744708|NCT04903093|Drug|Abrocitinib Suspension F3|Single dose of abrocitinib 200 mg oral suspension formulation 3 will be administered after an overnight fast of at least 10 hours.
15744709|NCT04903093|Drug|Abrocitinib Suspension F4|Single dose of abrocitinib 200 mg oral suspension formulation 4 will be administered after an overnight fast of at least 10 hours.
15744710|NCT04903093|Drug|Abrocitinib Suspension F5|Single dose of abrocitinib 200 mg oral suspension formulation 5 will be administered after an overnight fast of at least 10 hours.
15744711|NCT04903093|Drug|Abrocitinib Suspension F6|Single dose of abrocitinib 200 mg oral suspension formulation 6 will be administered after an overnight fast of at least 10 hours.
15744712|NCT04903093|Drug|Famotidine|Single dose of famotidine 40 mg tablet administered 2 hours prior to abrocitinib formulations under fasted conditions.
15744713|NCT04903080|Biological|HER2 Specific CAR T Cell|HER2 CAR (Chimeric Antigen Receptor) T cells are T cells that have been genetically engineered to target the protein HER2 for the treatment of cancer.
15744714|NCT04903054|Biological|Lulizumab|Lulizumab is a pegylated, humanized monovalent domain antibody construct that is specific for human cluster of differentiation CD28.
15744715|NCT04903054|Drug|Tacrolimus|Standard of Care: Renal transplant rejection prophylaxis.
15744716|NCT04903054|Biological|Thymoglobulin®|Standard of Care: Renal transplant rejection prophylaxis.
15744717|NCT04903054|Drug|Methylprednisolone|Standard of Care: Renal transplant rejection prophylaxis.
15744718|NCT04903054|Drug|Mycophenolate Mofetil|Standard of Care: Renal transplant rejection prophylaxis.
15744719|NCT04903054|Drug|Prednisone|Standard of Care: Renal transplant rejection prophylaxis.
15744838|NCT04902105|Drug|ecopipam HCL|oral tablets
15744724|NCT04903002|Drug|24-IU oxytocin|Patients will self-administer a 2-week course of 24-IU intranasal oxytocin [4-IU per puff (12-IU delivered to each nostril); Syntocinon, Novartis, Switzerland], twice per day (once in the morning and once in the evening).
15744725|NCT04903002|Drug|48-IU oxytocin|Patients will self-administer a 2-week course of 48-IU intranasal oxytocin [4-IU per puff (24-IU delivered to each nostril); Syntocinon, Novartis, Switzerland], twice per day (once in the morning and once in the evening).
15744726|NCT04903002|Drug|Placebo|Patients will receive an intranasal placebo containing the same ingredients as the oxytocin nasal spray with the exception of active oxytocin. Administration schedule and procedure will be identical to that described in 24-IU oxytocin.
15744727|NCT04902989|Other|pollutants and pollen|Pollutants (ozone, SO3, NO3, PM2.5, diesel exhaust particles)
15744728|NCT04902976|Other|CPC+ZN|In patients hospitalized in common beds, and without mechanical ventilation, the it will be asked to perform the following procedures: mouth rinse with 20 mL of the solution for 30 s
15744729|NCT04902976|Other|CPC|In patients hospitalized in common beds, and without mechanical ventilation, the it will be asked to perform the following procedures: mouth rinse with 20 mL of the proposed solution for 30 s;
15744730|NCT04902976|Other|Negative Control|In patients hospitalized in common beds, and without mechanical ventilation, the it will be asked to perform the following procedures: mouth rinse with 20 mL of distilled water for 30 s.
15744731|NCT04902963|Device|PE tube|Gelatin mixed with antibiotic and steroid ear drop to create a rigid device that maintains a lumen, acting as an intermediate-duration bioabsorbable ear tube.
15744732|NCT04902950|Drug|Tranexamic acid|"After the abdominal skin and subcutaneous tissue is raised, the area will be irrigated, and hemostasis achieved using electrocautery. These steps are currently preformed with every panniculectomy. The Tranexamic acid soaked lap sponges will be unfolded and placed beneath the two lateral portions as well as the central area of the flap for 3 minutes. The lap sponges will not be rung out prior to placement. The surface area under the flap will be measured from the xiphoid process to the pubis, from the Xiphoid process to each anterior superior iliac spine (ASIS) and across from one ASIS to the other. These measurements will be used to calculate the surface area under the flap. These measurements will only be used in data collection and do not affect the principle aim of the study. The remainder of the surgical procedure will be the same for each patient."
15744733|NCT04902950|Drug|Saline|"After the abdominal skin and subcutaneous tissue is raised, the area will be irrigated, and hemostasis achieved using electrocautery. These steps are currently preformed with every panniculectomy. The saline soaked lap sponges will be unfolded and placed beneath the two lateral portions as well as the central area of the flap for 3 minutes. The lap sponges will not be rung out prior to placement. The surface area under the flap will be measured from the xiphoid process to the pubis, from the Xiphoid process to each anterior superior iliac spine (ASIS) and across from one ASIS to the other. These measurements will be used to calculate the surface area under the flap. These measurements will only be used in data collection and do not affect the principle aim of the study. The remainder of the surgical procedure will be the same for each patient."
15744734|NCT04902937|Radiation|Adjuvant radiotherapy|Guideline-based therapy of primary non-metastatic early breast carcinoma
15744735|NCT04902937|Drug|neoadjuvant and adjuvant chemotherapy|Guideline-based therapy of primary non-metastatic early breast carcinoma
15744736|NCT04902924|Behavioral|repeated cold water therapy|This information can be found the description of the experimental arm.
15744737|NCT04902924|Behavioral|repeated warm water therapy|This information can be found the description of the experimental arm.
15744738|NCT04902924|Other|control|This information can be found the description of the experimental arm.
15744739|NCT04902911|Device|COVID-19 SARS-CoV IgG/IgM antibody rapid test|Needle stick point of care and 3mL vial of blood will be collected and tested for individual without history of COVID-19 and immunization as well as a second group composed of individuals with history of COVID-19
15744740|NCT04902898|Device|Circumcision in adults using sterile single-use circular stapling device|Circumcision in adults using sterile single-use circular stapling device CIRCCURER II (Jiangxi Langhe Medical Instrument Co., Ltd., Guangzhou, China)
15744741|NCT04902898|Procedure|Circumcision in adults|Circumcision in adults
15744742|NCT04902885|Drug|Trilaciclib|Group 1: Trilaciclib, carboplatin, etoposide，or Topotecan Group 2: Trilaciclib, Topotecan Group 3: Placebo, carboplatin, etoposide，or Topotecan
15744743|NCT04902872|Drug|CBX-12|CBX-12 is an alphalex construct which consists of a low-pH insertion peptide, a self-immolating linker, and exatecan as the pharmacologically active moiety
15744744|NCT04902859|Drug|Clonidine Oral Liquid Product|Clonidine prepared from pharmacy with 20 mcg/ml concentration.
15744745|NCT04902859|Drug|Sterile water|Sterile water used as placebo
15744746|NCT04902846|Diagnostic Test|Early kidney damage biomarkers|In the urine samples of these patients, a series of biomarkers of early kidney damage and / or predisposition to kidney damage will be measured.
15744747|NCT04902846|Diagnostic Test|Predisposition to kidney injury biomarkers|In the urine samples of these patients, a series of biomarkers of predisposition to kidney damage will be measured.
15744748|NCT04902833|Procedure|Blood Draw|Blood specimen 2-4 teaspoons
15744749|NCT04902820|Other|PrEPTECH website|The intervention is a web site delivering access to PrEP telehealth. The platform provides access to laboratory testing for PrEP eligibility delivered to a participant's home, telehealth care and PrEP prescriptions for those eligible delivered asynchronously through an online form for all adult participants and through telephone appointments for adolescent participants, and an online pharmacy for PrEP. Additionally, free PrEP medication will be provided through the intervention. Transgender female and adolescent cisgender male participants will receive free PrEP medication (emtricitabine [200 mg]/tenofovir disoproxil fumarate [300 mg]) for the duration of their participation in the study, while adult cisgender male participants will receive a free 30-day supply of PrEP and subsequently have to pay for PrEP medication through insurance, patient assistance programs, or out of pocket.
15744750|NCT04902820|Other|Online PrEP resource list|Participants will receive access to an online list of web-based resources about PrEP and how to locate and pay for PrEP care and contact information for a professional PrEP navigator at a local community-based organization partnering with the study.
15744751|NCT04902807|Biological|Collection of samples|Blood, Urine and Stool samples will be collected from the participants.
15744839|NCT04902105|Drug|Mefenamic acid|oral capsules
15744752|NCT04902794|Device|Light Emitting Diode|Blue light-emitting diode applied to the female genital region for eight minutes, for five sessions, one per week
15744753|NCT04902781|Drug|AT-007|Treatment with AT-007 given orally
15744754|NCT04902781|Other|Placebo|Placebo given orally
15744755|NCT04902768|Other|This is an observational study, there is no intervention|This is an observational study, there is no intervention. Hence, this is not applicable.
15744756|NCT04902755|Other|Questionnaire|validation of the French linguistic version and the cross-cultural adaptation of the NBSS-SF.
15744757|NCT04902742|Procedure|Fluoroscopy-guided ganglion impar block|Fluoroscopy guidance is used for correct visualization of injection site, and so obtained more successful results. Patients are placed in the prone position. Injection site is cleaned thrice with povidone iodine %10 solution and covered with sterile drapes. Being most commonly used technic, transsacrococcygeal technique, a 22-gauge, 1.5-inch spinal needle is advanced through the sacrococcygeal disk and positioned carefully anterior to the sacrococcygeal junction. Injection of contrast results in a classical comma sign. A mixture of steroid and local anesthetic is given.
15744758|NCT04902742|Procedure|Fluoroscopy-guided caudal epidural steroid injection|Fluoroscopy guidance is used for correct visualization of injection site, and so obtained more successful results. Patients are placed in the prone position. Injection site is cleaned thrice with povidone iodine %10 solution and covered with sterile drapes. An 18-gauge epidural needle (Tuohy) is advanced at an angle of 45° to the skin until a 'give-way' sensation is felt and position of the needle is confirmed by lateral and anteroposterior fluoroscopic images. Then 5 ml of iohexol solution is injected through it to confirm the position. A properly placed needle would produce a classical 'inverted fern tree' appearance in anteroposterior view after dye injection or a 'filling defect'. The needle is introduced up to S3 level for proper spread of the drug. A mixture of steroid and local anesthetics is given.
15744759|NCT04902729|Drug|Carbetocin|Patient is given carbetocin (80mcg) intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby.
15744760|NCT04902729|Drug|Oxytocin|Patient is given oxytocin (1IU) intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby, followed by infusion 80 mU/min (40 IU in 1L given at a rate of 120 mL/h).
15744761|NCT04902716|Behavioral|Design course|Precision nursing is a new trend in nursing in recent years. It is based on individual differences in disease type, gender, lifestyle, family, race, social and cultural factors, etc., to provide the most suitable empirical-based nursing treatment.Diverse courses include music, breathing exercises, cognitive training, hand-made knitting, etc.
15744762|NCT04902703|Drug|Sargramostim|Sargramostim is a granulocyte macrophage colony stimulating factor that will be administered at a dose of 250 mcg/m2 per day subcutaneously, 5 days/week, for 24 weeks
15744763|NCT04902703|Drug|Saline - placebo comparator|Saline will be administered subcutaneously, 5 days/week, for 24 weeks
15744764|NCT04902677|Other|Cross-sectional|No intervention
15744765|NCT04902664|Behavioral|Patient education materials|Patients receive a text-message and/or email with educational materials about medical testing.
15744766|NCT04902664|Behavioral|Physician peer-comparison email|Physicians receive an email with feedback on how they compare to their peers in aggregate on test ordering during annual physicals.
15744767|NCT04902664|Behavioral|Physician education materials|Physicians receive reference materials on medical test interpretation and incidental findings.
15744768|NCT04902664|Behavioral|General visit preparation materials|Patients receive a text-message and/or email with general visit preparation tips.
15744769|NCT04902651|Device|HM242-Gel|HM242-Gel compared to Intrasite Gel in patients with a venous leg ulcer
15744770|NCT04902651|Device|Intrasite Gel|HM242-Gel compared to Intrasite Gel in patients with a venous leg ulcer
15744771|NCT04902638|Procedure|Intraarticular injection of dexamethasone|Intraarticular injection of dexamethasone
15744772|NCT04902625|Drug|Naltrexone-Bupropion Combination|Naltrexone-bupropion will be added to the BOT module in the interventional arm.
15744773|NCT04902612|Device|HM242-Solution|HM242-Solution compared to Saline compared in patients with a venous leg ulcer
15744774|NCT04902612|Device|Saline|HM242-Solution compared to Saline compared in patients with a venous leg ulcer
15744775|NCT04902599|Procedure|Renuvion/j-Plasma procedure using blunt dissection technique|Renuvion/j-Plasma procedure using blunt dissection technique
15744776|NCT04902599|Procedure|Renuvion/j-Plasma procedure using ultrasound-guided dissection technique|Renuvion/j-Plasma procedure using ultrasound-guided dissection technique.
15744777|NCT04902586|Device|TTFields|The TTFields, consisting of low-intensity, 200 kHz frequency, alternating electric fields, was delivered (≥ 18 hours/d) via 4 transducer arrays on the shaved scalp and connected to a portable device.
15744778|NCT04902573|Other|Non-interventional|As this is a non-interventional trial, only data obtained within the current routine management of asthma at outpatient respiratory centres or GP centres will be documented.
15744779|NCT04902547|Behavioral|Patient Education Workshop (PEWs)|The comprehensive workshops will include a combination of didactic and interactive content on general pain and opioid education (1 hour workshop session to be co-presented by Drs Ryan Amadeo and Dana Turcotte) along with significant psychological content (co-presented by Drs Brigitte Sabourin and Gregg Tkachuk) making up the remainder of the day-long workshop. Content presented in PEWs will include opioid-related risks, identifying personal motivation for (or barriers to) tapering, goal setting, pain self-management, sleep hygiene and comprehensive focus on ACT and rethinking pain. During the interprofessionally co-facilitated sessions, participants will be provided with workbooks that will contain session specific content as well as take-home activities and information for their own personal use.
15744780|NCT04902547|Procedure|Multidisciplinary Tapering Program|"The MTP will begin with a Baseline Tapering Visit and will include the same baseline health and well-being questionnaires, a medication review, relevant pain history, relevant opioid use history, discussion re: patient-specific tapering and functional goals, taper start date, and determination if a different opioid formulation will be required for the taper. A detailed taper plan will be prepared and reviewed by the study clinician(s) and provided to the patient. In general, tapers will begin with a 10% reduction of dose every 2 weeks until ⅓ of the original dose is met, or until taper goal has been met. If further tapering is planned once the patient reaches ⅓ of their original dose, the taper will be reduced to half the volume and rate noted above in order to improve tapering success.
~Tapering plans and approaches may be changed (slowed, increased, halted etc.) based on follow up."
15744781|NCT04902534|Drug|Naoqingzhiming Tablets (contains echinacoside 180mg)|Single dose escalation and multiple dose escalation
15744782|NCT04902534|Drug|placebo of Naoqingzhiming Tablets (without echinacoside)|Single dose escalation and multiple dose escalation
15744783|NCT04902521|Device|Transcranial magnetic stimulation|Repetitive transcranial magnetic stimulation (TMS) is a safe non-invasive technique that stimulates the brain using repetitive magnetic pulses to enhance neuroplasticity. TMS has been shown to produce lasting modulation of cortical activity and improve clinical symptoms of children with neurodevelopmental disorders including CP
15744784|NCT04902521|Device|Sham Transcranial Magnetic stimulation|Sham Transcranial Magnetic stimulation will be given to the control group. During the Sham procedure patients will sit near the TMS but will not receive any magnetic pulses.
15744785|NCT04902508|Behavioral|Implicit-only|Each intervention session will comprise four core activities: sentence imitation, presentation of a model story with production opportunities, and auditory bombardment.
15744786|NCT04902508|Behavioral|Explicit-added|Each intervention session will comprise four core activities: sentence imitation, presentation of a model story with production opportunities, and auditory bombardment. Interventionists will also present the rule/pattern guiding the target form.
15744787|NCT04902495|Other|MTA Pro Root|pulp therapy
15744788|NCT04902495|Other|MTA HP Repair|pulp therapy
15744789|NCT04902495|Other|Biodentine|pulp therapy
15744790|NCT04902482|Device|iCycle Mark 3|The iCycle Mark 3 is a cycle ergometer, designed to be used by people with SCI while they are seated in their own wheelchairs. The purpose of iCycle is to stimulate the leg muscles in the correct phase for cycling while motivating the person with a Virtual Reality cycling event, perhaps a race, to try to use their muscles.
15744791|NCT04902469|Behavioral|Pleasant Odor|Each participant in the pleasant odor condition will sniff an odor that they rated as the most intense out of a sample of odors rated to be pleasant. Odors are generic and commercially available in supermarkets such as vanilla, coconut, and chocolate. Importantly, the investigators are not testing the specific odors, rather the participant's idiosyncratic response to a menu of odors. In other words, the key is that each participant in the experimental condition receives the odor that they like the best, regardless of which one it is.
15744792|NCT04902469|Behavioral|Odor Blank|Each participant in the odor blank condition will sniff a neutral olfactory cue (odor blank). This involves a container with no added scent. This serves as the control condition.
15744793|NCT04902456|Procedure|Power chain and Crimpable hook fro En-masse Retraction|"Retraction will start on a 0.017x0.025 stainless steel wire using elastomeric chain ( for applied will be 212 g per side ) extending between the cripmable hooks and the miniscrew"
15744794|NCT04902456|Procedure|T-loop|closing retraction T-loops will be fabricated using 0.017x0.025 TMA wire. The loop will be positioned halfway the extraction space and the canine.
15744797|NCT04902430|Procedure|Power chain and Crimpable hook for En-Masse Retraction|"Retraction will start on a 0.017x0.025 Stainless steel wire using elastomeric chain (force applied will be 212 g per side) extending between the crimpable hooks and the miniscrew"
15744798|NCT04902430|Procedure|T- Loop|Closing retraction T-loops will be fabricated using 0.017 x 0.025 TMA wire. The loop will be positioned halfway the extraction space and the canine
15744799|NCT04902417|Other|Dairy Foods (Yoghurt, Cheese, Milk)|Participants will be provided with a combination of dairy products (Yoghurt, Cheese, Milk) to be consumed daily, for a total of 3 servings per day
15744800|NCT04902404|Other|First Pathways Game|The First Pathways Game is a free, online parenting education program. Parents watch short videos (approximately 30 seconds) on the First Pathways Game website to receive neuroscience knowledge and ideas for age-appropriate game ideas to play with their child. The game ideas employ common household items, such as measuring cups and paper.
15744801|NCT04902391|Other|Health Services|The Acute Mental Health Care Bundle consists of 3 core elements, including: (1) ED triage, (2) ED assessment and care, and (3) follow-up care.
15744802|NCT04902378|Device|Tandem t:slim X2 insulin pump with Control IQ technology|The intervention group will be fitted with the Tandem t:slim X2 insulin pump with Control IQ technology during pregnancy.
15744803|NCT04902365|Other|neurofeedback|(based on real-time functional magnetic resonance signals)
15744804|NCT04902352|Procedure|No Periadventitial dissection of the SMA|lymphoneural tissue around SMA left intact
15744805|NCT04902352|Procedure|Periadventitial dissection of the SMA|"For the patients randomised for peri-adventitial dissection the right side of the SMA should be completely clear from lymphoneural tissue for at least 180 degrees on right side and from angle of the artery to the level of inferior border of the uncinate process. In the presence of an accessory or replaced right hepatic artery the peri-adventitial dissection should also be carried out around this vessel as well."
15744806|NCT04902339|Behavioral|Mindfulness-Oriented Recovery Enhancement|8 weeks of therapy integrating mindfulness, reappraisal, and savoring skills.
15744807|NCT04902339|Other|Neurofeedback|Near-infrared spectroscopy neurofeedback during savoring practice.
15744808|NCT04902339|Behavioral|Supportive Psychotherapy|8 weeks of supportive, process-oriented psychotherapy.
15744809|NCT04902326|Behavioral|Automated educational text messages|"During the first two weeks, participants receive a series of educational messages delivered via text message. These messages welcome participants to the study, set expectations for the next 12 months, and establish a general level of knowledge among all participants on prediabetes, the Diabetes Prevention Program (DPP), and metformin.
~For the next 11.5 months, participants receive three automated text messages per week that provide evidence-based educational content about prediabetes and tips on prevention. Additionally, participants receive monthly messages reminding them about their health insurance plan's coverage of the DPP at no cost and coverage of metformin as a low co-pay medication, and monthly messages providing feedback on their participation in the DPP and use of metformin in the previous calendar month. Participants' PCPs receive quarterly chart updates about participation in the DPP and use of metformin, and A1c results at enrollment and 6 and 12 months."
15744840|NCT04902105|Drug|Divalproex Sodium ER|oral tablets
15744810|NCT04902326|Behavioral|Autonomy-supportive automated educational text messages|Participants receive the same text messages as in the automated educational text message intervention, but the thrice weekly messages have been modified, where applicable, to support the participant's autonomy, in accordance with principles of Self-Determination Theory. Participants' PCPs receive quarterly chart updates about participation in the DPP and use of metformin, and A1c results at enrollment and 6 and 12 months.
15744811|NCT04902326|Behavioral|Financial incentives|Participants in this arm have the opportunity to earn a financial incentive ranging from $50 to $250 per month for taking an evidence-based action to prevent T2DM (i.e., engagement in a DPP or fill of a metformin prescription) in the previous month.
15744812|NCT04902326|Behavioral|Tailored text messages|Participants receive twice-weekly tailored text messages that link evidence-based actions to prevent T2DM to the participant's self-identified top values, roles, and strengths. Text messages are also tailored, when possible, to participants' self-reported importance of taking action to try to prevent T2DM (i.e., participating in the DPP or taking metformin), confidence in being able to take such preventive action, and past preventive actions taken.
15744813|NCT04902313|Behavioral|Awareness and insight Modules (AiM)|12 week of daily reflection and meditation exercises, delivered by mobile phone text messages, after 3-4 live introduction sessions.
15744814|NCT04902300|Other|Data collection|evaluation of internet addiction
15744815|NCT04902287|Behavioral|Training Intervention for the Engagement of Families (TIES)|This intervention involves training service personnel in a method of communication that elicits a person's intrinsic motivation for change.
15744816|NCT04902274|Other|Transcranial Direct Current Stimulation|The Halo Sport (Halo Neuroscience, San Francisco, CA) is a commercial off-the-shelf tDCS device that delivers a 2.2 mA current to the motor cortex through three elastomer foam scalp pads with a 24 sq. cm surface area (see https://www.haloneuro.com/). The tDCS is controlled through the Halo Sport App where the therapist and patient are blind to an actual or sham treatment. Patients in the tDCS group will complete a 20-minute tDCS session while performing the warm-up.
15744817|NCT04902274|Other|Sham Transcranial Direct Current Stimulation|The Halo Sport (Halo Neuroscience, San Francisco, CA) is a commercial off-the-shelf tDCS device that delivers a 2.2 mA current to the motor cortex through three elastomer foam scalp pads with a 24 sq. cm surface area (see https://www.haloneuro.com/). The tDCS is controlled through the Halo Sport App where the therapist and patient are blind to an actual or sham treatment. Patients in the sham tDCS group will complete a 20-minute sham-tDCS session while performing the warm-up, but the app will discontinue the treatment after 30 seconds.
15744818|NCT04902274|Other|Physical Therapy|After the tDCS session is complete, the patient will complete treatment consistent with the standard of care for rehabilitation of acute ankle inversion sprain. The rehabilitation program will be standardized among all patients and will consist of therapeutic exercises, manual physical therapy, and other modalities. Rehabilitation sessions will be performed 2x weekly and sessions will last approximately 45 to 60 minutes. Patients will also perform a standardized home exercise program that reinforces the in-clinic treatment.
15744819|NCT04902261|Drug|Tislelizumab|Tislelizumab 200 mg every three weeks
15744820|NCT04902261|Drug|Nab paclitaxel|Nab-paclitaxel 125mg/m2 on d1 and d8 every three weeks
15744821|NCT04902261|Drug|Gemcitabine|Gemcitabine 1000mg/m2 on d1 and d8 every three weeks
15744822|NCT04902248|Device|The OTSC® System Set|The endoscope was extracted and equipped with the OTSC system. OTSC system is deployed on the lesion with suction to target lesion
15744823|NCT04902248|Procedure|angiographic embolization|Transcatheter selective embolization to bleeding arteries
15744824|NCT04902235|Drug|Experimental: CRH administration|CRH at 1.0 µg/kg/body weight will be injected intravenously as a bolus over 30 seconds and samples will be collected over 2 hours (15 (T15), 30 (T30), 45 (T45), 60 (T60'), 90 (T90) and 120 (T120) minutes) after CRH:placebo administration to assess OT secretory patterns
15744825|NCT04902235|Drug|Control: Placebo administration|Sodium Chloride 0.9% will be administered intravenously as a bolus over 30 seconds at equivalent volume than CRH administration (1.0 µg/kg/body weight)
15744826|NCT04902222|Drug|Morphine|Administration of 0.1 mg/kg (IBW) intravenous morphine
15744827|NCT04902209|Procedure|postural stability measurements|"Static balance assessment on bi-module stabilometric platform CQStab2P. It registers the movement of centre of foot pressure (COP).
~Harris hip score- disability assesment"
15744828|NCT04902196|Other|high intensity cardiorespiratory exercise protocol|During the high intensive cardiorespiratory exercise protocol, a bicycle ergometer (eBike Basic, General Electric GmbH, Bitz, Germany) with pulmonary gas exchange analysis (MetaMax 3B, Cortex Biophysik GmbH, Leipzig, Germany) will be used. Oxygen uptake (VO2max), expiratory volume (VE) and respiratory exchange rate (RER) will be tracked every breath and an average will be taken every 10s. Heart rate is continuously monitored using a heart rate chest strap (Polar Electro Inc., Finland). After a five-minute warm-up, a high-intensity interval protocol is started, consisting of five one-minute bouts (110 reps/minute at 100% VO2max workload), separated by one minute of active rest (75 reps per minute at 50% VO2max workload).
15744829|NCT04902196|Other|moderate intensity cardiorespiratory exercise protocol|During the moderate intensive cardiorespiratory exercise protocol, a bicycle ergometer (eBike Basic, General Electric GmbH, Bitz, Germany) with pulmonary gas exchange analysis (MetaMax 3B, Cortex Biophysik GmbH, Leipzig, Germany) will be used. Oxygen uptake (VO2max), expiratory volume (VE) and respiratory exchange rate (RER) will be tracked every breath and an average will be taken every 10s. Heart rate is continuously monitored using a heart rate chest strap (Polar Electro Inc., Finland). After a five-minute warm-up, participants begin a moderately-intensive continuous 14-minute exercise protocol at a stable resistance (90 repetitions per minute at 60% VO2max workload).
15744830|NCT04902183|Drug|CovenD24|The drug will be administrated once daily for 5 days
15744831|NCT04902170|Procedure|25 gauge pars plana vitrectomy|25 gauge pars plana vitrectomy
15744832|NCT04902157|Diagnostic Test|Cycle threshold|cycle threshold number
15744836|NCT04902131|Drug|A MENOPUR solution for injection in pre-filled pen, 600 IU/0.96 mL|Single dose cross-over bioequivalence trial
15744837|NCT04902131|Drug|A MENOPUR powder including solvent for solution for injection, 75 IU|Single dose cross-over bioequivalence trial
15744841|NCT04902092|Behavioral|High Intensity Interval Training|Exercise sessions will commence with an initial 3-week accustomization period whereby training load will increase incrementally from 2 x 45min sessions with effort peaking at 60% VO2 max (week 1) increasing to 3 x 45minute with effort peaking at 80% VO2max (week 3). Participants will transition to the full HIIT protocol for the remaining weeks. The HIIT component will comprise a work-rest ratio of ≥1:1minutes, with alternating exertion epochs at >80% VO2max and <60% VO2max. As VO2max is likely to increase as fitness improves toward the end of the 3-month program, adjustments to HIIT will be made by the exercise physiologist based on real-time heart rate monitoring, ensuring greater accuracy in participants achieving their heart rate targets.
15744842|NCT04902092|Behavioral|Strength and Resistance Training|Exercise sessions will comprise a combination of strength, coordination and mobility exercises. The strength component will consist of 2-3 sets of resistance exercises at ≤70% of a predicted 1 repetition maximum, targeting all body segments. Heart rate tracking will occur to ensure participants do not exceed 70% v02 (or exceed Lactate Threshold).
15744843|NCT04902079|Device|Device for Cardiac Contractility Modulation Therapy (CCM)|Evaluate the effect from CCM Therapy in HF population
15744844|NCT04902066|Other|Cognitive Behavioural Virtual Reality Therapy.|Cognitive Behavioural Therapy augmented with Virtual Reality.
15744845|NCT04902066|Other|Traditional Cognitive Behavioural Therapy|Traditional Cognitive Behavioural Therapy for psychosis.
15744846|NCT04902053|Diagnostic Test|Subjects previously implanted with INSPIRIS RESILIA Model 11500A and are undergoing planned valve-in-valve treatment.|Designed to capture Adverse Event information and valve measurement data from dysfunctional INSPIRIS RESILIA aortic valves before and after Valve-in-valve (ViV) treatment.
15744847|NCT04902040|Biological|Atezolizumab|Given IV
15744848|NCT04902040|Drug|Avelumab|Given IV
15744849|NCT04902040|Biological|Durvalumab|Given IV
15744850|NCT04902040|Biological|Nivolumab|Given IV
15744851|NCT04902040|Biological|Pembrolizumab|Given IV
15744852|NCT04902040|Drug|Plinabulin|Given IV
15744853|NCT04902040|Radiation|Radiation Therapy|Undergo radiation therapy
15744854|NCT04902027|Drug|Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)|All subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2, IV, on day 1 of each 21-day cycle (q3w).
15744855|NCT04902014|Behavioral|Motivational Interviewing|The individuals will be scheduled for and participate in six biweekly in person SDT based MI sessions. These sessions will take place in the HPCRL at CSU. The MI sessions will be conducted by a PhD student who has been trained by a MI practitioner. Participants will be provided a log book and will be asked to log their PA, with the goal of completing at least 150 minutes of PA per week. They will set biweekly PA goals, which will be discussed in the MI sessions. These participants will also receive general physical activity guidelines education and information on strategies to reach the recommended amount of activity per week during the initial baseline assessment meeting.
15744856|NCT04902014|Behavioral|Education|These participants will receive general physical activity guidelines education and information on strategies to reach the recommended amount of activity per week during the initial baseline assessment meeting. These participants will not do any other study related activities. At the conclusion of the study, these participants will be offered the chance to participate in one MI session.
15744857|NCT04902014|Behavioral|Wearable Fitness Trackers|Individuals assigned to this experimental condition will be given a wrist-worn WFT and will be instructed to wear it for the duration of the study. They will also download the corresponding mobile application on their smartphones. They will be trained by a member of our team on how to utilize the WFT and mobile application. The intended WFT tracks daily steps, miles traveled, kcals expended, and daily activity time. This device provides these data to the wearer via a small screen. Participants will be instructed to aim to complete at least 150 minutes of PA per week. Researchers will have the capability to track participant daily PA via the WFT and associated API. These individuals will be asked to set biweekly PA goals. These participants will also receive general physical activity guidelines education and information on strategies to reach the recommended amount of activity per week during the initial baseline assessment meeting.
15744858|NCT04902014|Behavioral|Wearable Fitness Tracker+|These individuals will be given the wrist-worn WFT, be instructed to wear it for the duration of the study AND be scheduled for six SDT based MI sessions. These participants will also be trained by a member of our team on how to utilize the WFT and associated application. They will be instructed to aim to complete 150 minutes of PA per week. These participants will be asked to set biweekly PA goals which will be discussed in MI sessions. Researchers will have the capability to track participant daily PA via the WFT and associated API. These participants will also receive general physical activity guidelines education and information on strategies to reach the recommended amount of activity per week during the initial baseline assessment meeting.
15744859|NCT04902001|Behavioral|Multidisciplinary weight loss|The adolescents will follow a 12-week intervention combining nutritional education, physical activity 3 times per week and psychological supports.
15744860|NCT04901988|Drug|Nivolumab 10 MG/ML|Eligible patients randomised to Arm B will receive 480 mg nivolumab monotherapy 4 weekly via IV infusion for up to 2 years.
15744861|NCT04901975|Drug|Spironolactone|Spironolactone is a mild diuretic. Drug dosage will be those used clinically and per the CHOP formulary: 3 mg/kg/day in divided doses every 6-24 hours; the drug will be weight adjusted every ~0.5 kg with a maximum dosage of 200 mg/24 hours. Maximum single dose is 100 mg. Spironolactone, the aldosterone antagonist to be utilized in Specific Aim 2 of this study, is FDA approved, has been on the market for many years and is routinely administered to all types of children with congenital heart disease including SV patients. The choice of which patient this should be administered to is up to the clinician and their patients and therefore, not all SV patients are on this medication.
15744862|NCT04901962|Device|JOBST® Confidence compression garments|JOBST® Confidence (JC) compression garments will be used for daytime treatment of leg or arm lymphedema. JC compression garments exert a specific therapeutic external, physical compression level and are therefore intended to use for the management of edema. JC comprise non-invasive medical devices with no direct contact with injured skin or mucous membranes and are intended for use on intact skin only.
15744863|NCT04901936|Drug|Pegcetacoplan|Complement (C3) inhibitor
15744864|NCT04901923|Drug|ACP-196|Participants will receive ACP-196 oral capsule(s) in all parts.
15744972|NCT04901117|Drug|Colloidal Bismuth Pectin|Use according to the drug combination options selected by each center.
15744865|NCT04901923|Drug|Itraconazole|Participants will receive itraconazole 200 mg capsules BID from Days 4 to 8 with meals and then 200 mg capsule QD on Day 9 under fasting state.
15744866|NCT04901910|Behavioral|Physical Activity (PA) Social Media Group|Participants will have access to the secret Social Media page that will deliver health information focused on increasing healthy activities and well-being. This information will be posted by e-coaches. Participants can interact with the e-coaches as well as other study members in the group.
15744867|NCT04901910|Behavioral|Verdi plus PA Social Media Group|Participants will have access to the secret Social Media page that will deliver health information focused on increasing healthy activities, well-being, and reducing risky behaviors. This information will be posted by e-coaches. Participants can interact with the e-coaches as well as other study members in the group.
15744868|NCT04901897|Device|kalifilcon A|kalifilcon A daily disposable contact lens
15744869|NCT04901897|Device|delefilcon A|DAILIES TOTAL1® (delefilcon A) daily disposable contact lenses
15744870|NCT04901897|Device|senofilcon A|Acuvue Oasys® 1-Day with HydraLuxe™ (senofilcon A) daily disposable contact lens
15744871|NCT04901884|Drug|PET/MR with 18F-FDG|(18F) Fluorodeoxyglucose (FDG) will be administered by intravenous injection at a dose of 4-5 MBq/kg.
15744872|NCT04901871|Drug|0.02 mg/kg, age<65|Remimazolam of 0.02 mg/kg will be infused in patients aged<65.
15744873|NCT04901871|Drug|0.07 mg/kg, age<65|Remimazolam of 0.07 mg/kg will be infused in patients aged<65.
15744874|NCT04901871|Drug|0.12 mg/kg, age<65|Remimazolam of 0.12 mg/kg will be infused in patients aged<65.
15744875|NCT04901871|Drug|0.17 mg/kg, age<65|Remimazolam of 0.17 mg/kg will be infused in patients aged<65.
15744876|NCT04901871|Drug|0.22 mg/kg, age<65|Remimazolam of 0.22 mg/kg will be infused in patients aged<65.
15744877|NCT04901871|Drug|0.27 mg/kg, age<65|Remimazolam of 0.27 mg/kg will be infused in patients aged<65.
15744878|NCT04901871|Drug|0.02 mg/kg, age≥65|Remimazolam of 0.02 mg/kg will be infused in patients aged≥65.
15744879|NCT04901871|Drug|0.07 mg/kg, age≥65|Remimazolam of 0.07 mg/kg will be infused in patients aged≥65.
15744880|NCT04901871|Drug|0.12 mg/kg, age≥65|Remimazolam of 0.12 mg/kg will be infused in patients aged≥65
15744881|NCT04901871|Drug|0.17 mg/kg, age≥65|Remimazolam of 0.17 mg/kg will be infused in patients aged≥65.
15744882|NCT04901871|Drug|0.22 mg/kg, age≥65|Remimazolam of 0.22 mg/kg will be infused in patients aged≥65.
15744883|NCT04901871|Drug|0.27 mg/kg, age≥65|Remimazolam of 0.27 mg/kg will be infused in patients aged≥65.
15744884|NCT04901858|Diagnostic Test|Aspiration of haemarthrosis and high definition MRI|Aspiration of haemarthrosis and high definition MRI
15744885|NCT04901845|Other|No intervention provided|Study is provided in the usual daily practice of the physicians without interventions made in their practice
15744886|NCT04901832|Other|Intradialytic stretching exercises|Exercises performed actively and passively to reduce or prevent muscle cramps during hemodialysis procedure.
15744888|NCT04901793|Behavioral|Virtual Reality Headset and handheld remote control.|Brand name: Oculus Quest
15744889|NCT04901780|Other|pragmatic posterior capsular stretch|pragmatic posterior stretch is used to increase the length of the posterior capsule
15744890|NCT04901780|Other|cross body stretch|crossbody stretch performed by an individual
15744891|NCT04901754|Drug|Camrelizumab Plus Apatinib|"-Drug: camrelizumab Camrelizumab intravenous infusion was administered at a dose of 200 mg on Day 1 of each 21-day cycle,until PD.
~Other Name: SHR-1210
~-Drug: Apatinib Mesylate Apatinib capsules 250 mg given orally , once daily in 21-day cycle ,until PD."
15744892|NCT04901741|Drug|Olaptesed pegol|400 mg per week as continous infusion until progression or intolerable toxicity
15744893|NCT04901728|Behavioral|Cultural Domain Analysis|80 and up to a maximum of 120 participants
15744894|NCT04901728|Behavioral|Focus Group Discussion|At least 18 and up to a maximum of 60 participants
15744895|NCT04901728|Behavioral|In-depth interview|At least 18 and up to a maximum of 36 participants
15744896|NCT04901715|Drug|Albuterol|Albuterol HFA Metered Dose Inhaler (90mcg/puff). Subjects to use 4 puffs one time.
15744897|NCT04901715|Diagnostic Test|Technetium99m - Sulfur Colloid (Tc99m-SC)|Aerosolized radiolabeled Tc99m-sulfur colloid will be delivered using a modified Pari-LC Star nebulizer. The activity of Tc99m-SC loaded in the nebulizer will be adjusted to provide an estimated 40 uCi deposited in the lung for the MCC/CC scan. Patients between the age 12-18 years old will receive ¾ of the adult dose to account for the smaller lung volume.
15744898|NCT04901702|Drug|Onivyde|Given intravenous on Days 1 and 8
15744899|NCT04901702|Drug|Talazoparib|Given orally twice on Day 1 (daily maximum is 1000mcg/day), then daily on Days 2-6
15744900|NCT04901702|Drug|Temozolomide|Given once a day on Days 1-5.
15744903|NCT04901676|Drug|Leronlimab|Leronlimab 700 mg (first dose) followed by weekly 350 mg
15744904|NCT04901676|Drug|Placebo|Placebo
15744905|NCT04901663|Drug|Omeprazole 20 MG Capsule; Amoxicillin 1000 MG; Clarithromycin 500 MG|Orally twice daily for 2 weeks
15744906|NCT04901663|Drug|Vonoprazan 20 MG; Amoxicillin 1000 MG|Orally twice daily for 2 weeks
15744907|NCT04901650|Diagnostic Test|Survey|A survey will be administered to find out the prevalence of pain in hospitalized patients for any cause and its intensity. The medical history will be reviewed to assess the presence of pain medications and their impact on the pain perception and patients' satisfaction.
15744908|NCT04901624|Behavioral|Family Risk Messaging|"Family risk framing may engender concern for loved ones. It may also make it easier to mentally simulate family burdens with COVID-19 such as knowing how several people in the family becoming sick could adversely affect the lives of everyone in the family. Households randomized to family risk messaging will receive the following message: Antibody testing will help you understand your family's risk of getting COVID-19."
15744909|NCT04901624|Behavioral|Personal Risk Messaging|"Personal risk framing may engender concern for oneself. Households randomized to personal risk messaging will receive the following message: Antibody testing will help you understand your risk of getting COVID-19."
15744910|NCT04901624|Behavioral|Loss Protection|Household members are offered a baseline incentive with a 90% (9 in 10) chance of $60 and receive insurance on winning the baseline incentive for repeat antibody testing.
15744911|NCT04901624|Behavioral|Lottery Incentive|Household members are offered a baseline incentive with a 90% (9 in 10) chance of $60 and receive a bonus lottery incentive with a 4 small (1 in 25) chance of winning $150 for repeat antibody testing.
15744912|NCT04901611|Behavioral|Parental touch|Parental touch in the form of stroking at 3cm/s for 10 seconds on the posterior lower limb where the heel lance will be/has been administered
15744913|NCT04901598|Other|Running anaerobic sprint test and aerobic test|subjects walk a mile with maximum steps and their heart rate will not exceed 180 beats per minute during the test and the execution time will not be less than 9 minutes (RAST test)
15744914|NCT04901585|Procedure|Totally intracorporeal distal gastrectomy|Minimally invasive distal gastrectomy with intracorporeal anastomosis and handsewn enterotomy closure
15744915|NCT04901572|Diagnostic Test|QISI device|QISI device will simulate its use in ICSI procedures and evaluate sperm cells according to WHO guidelines.
15744916|NCT04901559|Procedure|Graft type at ACLR|The choice of graft at primary ACL Reconstruction
15744917|NCT04901546|Other|Patient's own saliva|Infants with esophageal atresia will be given their own saliva
15744918|NCT04901533|Procedure|O-A-A|patient is supine, and the therapist stands on the side to be manipulated. The cranial hand of the therapist globally grasps the patient's skull and turns the patient's neck on that same side. The caudal hand is placed on the patient's face. The technique is performed by an impulse in pure rotation on the side that the cervical region is rotated, with a helical movement.
15744919|NCT04901533|Procedure|cranial listening|The patient is in the supine position, and the therapist sitting at the head of the patient. The therapist places his hands on the head of the patient, the thumbs touch each other, without touching the vault cranial. A perception of the cranial rhythm is carried out passively.
15744920|NCT04901520|Other|High Intensity Training|High Intensity Training group performed resistance training with the intensity of 80 - 90 % of 1RM with 4 - 6 repetition
15744921|NCT04901520|Other|Moderate Intensity Training|Moderate Intensity Training group performed resistance training with the intensity of 65 - 75 % of 1RM with 8 - 10 repetition
15744922|NCT04901520|Other|Low Intensity Training|Low Intensity Training group performed resistance training with the intensity of 50 - 60 % of 1RM with 12 - 14 repetition
15744923|NCT04901507|Device|The Voutia System|Participants will wear the Voutia System oral irrigation device continuously through the day and night, removing for cleaning and if otherwise necessary, but not for time extending beyond six-eight hours.
15744924|NCT04901494|Drug|SSRI|Selective serotonin reuptake inhibitor
15744925|NCT04901481|Device|Empower Neuromodulation System|Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.
15744926|NCT04901468|Other|No Intervention|This is an observational study
15744927|NCT04901455|Biological|LAIV|Standard dose of LAIV administered by a licensed health care providers.
15744928|NCT04901442|Device|Aetrex L700 Speed orthotic|An orthotic insole to be inserted into running shoes. Features Aetrex Arch Support to help biomechanically align the body & help prevent common foot pain such as Plantar Fasciitis, Arch Pain, and Metatarsalgia. Helps prevent injury, alleviate discomfort and helps reduce fatigue while running
15744929|NCT04901429|Procedure|Truncal vagotomy|Truncal vagotomy will be performed in 50% of patients during other routine procedure.
15744930|NCT04901416|Biological|DVX201|"Based upon the occurrence of DLT (does limiting toxicity), the MTD will be estimated as the highest dose at which the toxicity probability is the closest to the target probability (denoted pT=0.30) following up to 2 doses of DVX201. The corresponding dose allocation methodology is a modified toxicity interval design based upon (Ji et al., 2010; Ji et al., 2013).
~All patients who have at least one dose initiated will be included in the safety analysis. Patients who are enrolled but never exposed to investigational product will be replaced for all analyses. Patients who get exposed to lymphodepleting chemotherapy will be followed and reported for outcomes overall, but for determination of safety and efficacy, only those subjects who have been exposed to the investigational agent will be included."
15744931|NCT04901403|Other|Education|Parents will be provided with information about Earned Income Tax Credits and budgeting
15744932|NCT04901403|Other|Home visiting|Parents as Teachers home visiting program
15744933|NCT04901390|Dietary Supplement|Yogurt with B. lactis and added cane sugar|The intervention condition will utilize a commercially available yogurt (Activia) that contains Bifidobacterium animalis lactis DN-173 010/CNCM I-2494 (B. lactis). Participants will consume 170 g of yogurt with cane sugar twice daily for 14 days.
15744934|NCT04901377|Combination Product|Estradiol valerate/ Dienogest|Combined hormonal contraceptive (combined oral contraceptives, COCs)
15744935|NCT04901364|Behavioral|Sensitivity and specificity of risk factors for degeneration of IPMNs|Measurement of high-grade dysplasia or invasive cancer on the histological analysis of the surgical specimen
15744936|NCT04901351|Procedure|Smear|In addition to the routine gynecological follow-up including a cervico-vaginal smear and an HPV test (HPV-HR genome detection), the doctor will propose prospectively to all consecutive patients who meet the inclusion criteria, during a follow-up consultation (post treatment of cervical dysplasia), to participate in the study, that is to have 2 other anal and ENT samples for an HPV test
15744937|NCT04901325|Drug|Baricitinib|Subjects with PG will be treated with 4 mg once daily of baricitinib for 24 weeks.
15744938|NCT04901312|Behavioral|Adolescent Community Reinforcement Approach|The Adolescent Community Reinforcement Approach (A-CRA) is a developmentally-appropriate behavioral treatment for youth and young adults ages 12 to 24 years old with substance use disorders. A-CRA seeks to increase the family, social, and educational/vocational reinforces to support recovery. This intervention has been implemented in outpatient, intensive outpatient, and residential treatment settings. A-CRA includes guidelines for three types of sessions: individuals alone, parents/caregivers alone, and individuals and parents/caregivers together. According to the individual's needs and self-assessment of happiness in multiple life areas, clinicians choose from a variety of A-CRA procedures that address, for example, problem-solving skills to cope with day-to-day stressors, communication skills, and active participation in positive social and recreational activities with the goal of improving life satisfaction and eliminating alcohol and substance use problems.
15744973|NCT04901117|Drug|Vonoprazan fumarate|Use according to the drug combination options selected by each center.
15744974|NCT04901104|Drug|Thymosin Alpha1|Drug interventions have been done in previous clinical studies
15744975|NCT04901091|Other|Not Provided|Not Provided
15744939|NCT04901312|Behavioral|Assertive Continuing Care|Assertive Continuing Care (ACC) uses Community Reinforcement Approach (CRA) procedures, home visits, and case management for individuals following an initial substance use treatment episode. It stresses rapid initiation of services after discharge from residential, intensive outpatient, or regular outpatient treatment in order to promote recovery and prevent relapse.
15744940|NCT04901312|Behavioral|Trauma Affect Regulation Guide for Education and Therapy|Trauma Affect Regulation: Guide for Education and Therapy is a psychosocial intervention for traumatized adolescents, adults, and families, and for workforce and organizational responses to secondary/vicarious traumatization. T4, the 4-session version, provides education about the impact of complex traumatic stress on the brain's stress response system, and strengths-based practical skills for re-setting the trauma-related alarm/survival reactions that occur in complex PTSD.
15744941|NCT04901312|Behavioral|Motivational Interviewing|Motivational interviewing is a collaborative, person-centered form of guiding to elicit and strengthen motivation for change.
15744942|NCT04901312|Other|Opioid Education Workbook|A digital workbook designed to be completed on a computer in about 2 hours. Topics include opioid use, opioid use disorder, and prevention and treatment of opioid overdose.
15744945|NCT04901286|Behavioral|Exercise Only|Cycling in a lab environment
15744946|NCT04901286|Behavioral|Exercise + Non-Immersive Virtual Reality|Cycling with an environment simulated by non-immersive virtual reality
15744947|NCT04901286|Behavioral|Exercise + Immersive Virtual Reality|Cycling with an environment simulated by immersive virtual reality
15744948|NCT04901273|Procedure|Homologous PRP injections|Patients will be treated with a single injection of Homologous PRP (5 ml) in the knee joint affected by osteoarthritis.
15744949|NCT04901273|Procedure|Placebo injection (saline solution)|Patients will be treated with a single injections of saline solution (5 ml) in the knee joint affected by osteoarthritis
15744950|NCT04901260|Device|AMAZE™ Disease Management Platform|The disease management platform includes a patient mobile application where patients can enter daily symptoms, communicate with their healthcare providers, and access educational materials. Additionally, the healthcare providers will have access to a dashboard that is integrated with the EMR and patient app.
15744951|NCT04901247|Behavioral|media refreshment|20µL of culture medium is aspirated using Eppendorf PCR tips, and freshly, overnight equilibrated 20µL global total LP will be added to the same well
15744952|NCT04901247|Behavioral|embryo grading|embryo grading should be done prior to media refreshment
15744953|NCT04901234|Radiation|Standard radiotherapy +/- chemotherapy|No radiotherapy adaptation unless major dosimetric deviation
15744954|NCT04901234|Radiation|Experimental radiotherapy +/- chemotherapy|Systemic MRI-based radiotherapy adaptation mid-treatment
15744955|NCT04901221|Device|Extrusion arch|one couple force system is applied; a hand made extrusion wire from 0.016x0.022 stainless steel wire with helical bends placed 2-5 mm mesial to the molar tube placed in the upper and lower arches and tied distal to the lateral incisors
15744956|NCT04901208|Drug|Nicotine pod|Nicotine pods administered to individuals who use Juul
15744957|NCT04901208|Drug|Placebo pod|Nicotine-free pods administered to individuals who use Juul
15744959|NCT04901182|Diagnostic Test|the effect of consuming diets on the swallowing capacity by using Flexible Endoscopic Evaluation of Swallowing (FEES)|the effect of consuming white sesame soy milk smoothie (WS), Chicken shitake smoothie (CS) vs. Ensure on the swallowing capacity by using Flexible Endoscopic Evaluation of Swallowing (FEES)
15744960|NCT04901169|Drug|Angiotensin II|Infusion of Angiotensin II initiated if participants require norepinephrine at a rate of > 0.05 mcg/kg/min. The infusion will be titrated no more frequently than every 10 minutes during liver transplantation as a second line vasopressor and discontinued prior to leaving the operating room when the surgery is complete.
15744961|NCT04901169|Drug|Saline|Infusion of 0.9% saline initiated if participants require norepinephrine at a rate of > 0.05 mcg/kg/min. The infusion will be titrated no more frequently than every 10 minutes during liver transplantation as a second line vasopressor and discontinued prior to leaving the operating room when the surgery is complete.
15744962|NCT04901156|Device|1Hz inhibitory rTMS|20 minutes of 1Hz (1200 pulses) repetitive transcranial magnetic stimulation (rTMS) applied by Magstim Rapid 2 stimulator equipped with an airfilm figure-8 coil
15744963|NCT04901156|Behavioral|Multi-Modality Aphasia Therapy (M-MAT)|Participants receive 3.5 hours of intensive speech therapy in small groups delivered by a blinded speech language pathologist and therapy assistant. The objective of M-MAT is to improve word production through shaping of responses (ie. Gradually increasing complexity of spoken targets towards eventual mastery) and social-mediated repetitive practice. Therapists use game-based interactive tasks and rich multi-modal cueing (gestures, written words, drawing, reading words) to improve spoken production and oral communication.
15744964|NCT04901156|Device|1Hz sham rTMS|20 minutes of 1Hz (1200 pulses) repetitive transcranial magnetic stimulation (rTMS) applied by Magstim Rapid 2 stimulator equipped with an airfilm figure-8 sham coil.
15744965|NCT04901143|Device|Advanced hybrid closed loop system|Phase 1: meals in open loop- 3 weeks Phase 2: closed loop conventional meal announcement- 3 weeks Phase 3: closed loop, pre define universal bolus- 3 weeks
15744966|NCT04901130|Device|Computer-aided Real-time Automatic Quality Control System (AQCS)|Automatic quality-control system(AQCS), developed based on deep convolutional neural network (DCNN) models, could improve the colonoscopists' performance during withdrawal phase and significantly increase polyp and adenoma detection.
15744967|NCT04901117|Drug|Amoxicillin|Use according to the drug combination options selected by each center.
15744968|NCT04901117|Drug|Clarithromycin|Use according to the drug combination options selected by each center.
15744969|NCT04901117|Drug|Tetracycline|Use according to the drug combination options selected by each center.
15744970|NCT04901117|Drug|Metronidazole|Use according to the drug combination options selected by each center.
15744971|NCT04901117|Drug|Bismuth Potassium Citrate|Use according to the drug combination options selected by each center.
15744976|NCT04901078|Drug|KNX100|KNX100 will be provided in capsule form as both 25 and 100 mg capsules for oral administration. Study drug will be encapsulated in hydroxypropyl methylcellulose (HPMC) dark green opaque size 0 capsules and packaged in 100 mL high density polyethylene (HDPE) bottles with polypropylene (PP) twist-off closures.
15744977|NCT04901065|Drug|Xylocaine|The study intervention was the administration of 10 mg of intranasal lidocaine in one nostril using 1 spray of 0.1mL of a 10% lidocaine solution 5 minutes before NPS. This was done using the standard long nozzle
15744978|NCT04901065|Drug|Placebo|The control group received the placebo with the same application technique using an empty bottle of lidocaine 10% with the same long nozzle for delivery
15744979|NCT04901052|Dietary Supplement|n-3 supplementation group|n-3 supplementation group (1.5g of omega 3)
15744980|NCT04901052|Dietary Supplement|Placebo group|Placebo group (sunflower oil)
15744981|NCT04901039|Other|Lung ultrasound|Decompensated HF patients will be evaluated at admission and prior to hospital discharge with a range of tools including lung ultrasound imaging
15744982|NCT04901039|Other|Echocardiography|Comprehensive echocardiography with evaluation of filling pressures
15744983|NCT04901039|Other|Peripheral venous pressure|Assessment of peripheral venous pressure
15744984|NCT04901039|Other|Magnetic resonance imaging|Cardiac magnetic resonance imaging
15744985|NCT04901039|Other|Pulmonary scintigraphy|Assessment of pulmonary perfusion with scintigraphy
15744986|NCT04901026|Other|An in-house manikin|Participants obtain an in-house manikin
15744987|NCT04901013|Other|Affinity|Affinity is an aseptically processed, hypothermically stored fresh allograft with viable cells, growth factors/cytokines, and extracellular matrix (ECM).
15744988|NCT04901000|Procedure|Carotid endarterectomy|Carotid endarterectomy prior to CABG operations either under Local Anaesthetic or under General Anaesthetic.
15744989|NCT04900987|Device|Steri-strips|Pneumatic TR band compression with use of steri-strips
15744990|NCT04900974|Drug|Doravirine|100mg
15744991|NCT04900961|Other|Resistance Exercise|The exercise regimens are generic and designed not to require expert physiotherapy input, therefore, the availability of NHS physiotherapists, which may be at times limited, will not be a barrier to implementation
15744992|NCT04900948|Drug|Pimecrolimus cream 1%|Patients received pimecrolimus cream 1% 2 times a day for 3 months. Then use in a double application mode (morning / evening) 3 times a week for up to 1 year of age. Also, patients used emollients 1-2 times a day.
15744993|NCT04900948|Drug|cream 0.1% methylprednisolone aceponate|Patients received 0.1% methylprednisolone aceponate cream 2 times a week for 3 months, and then used for exacerbation of atopic dermatitis. Also, patients used emollients 1-2 times a day.
15744994|NCT04900935|Behavioral|POISE|POISE (Patient-centered, Optimal Integration of Survivorship and palliative carE) is a brief, population-specific intervention that consists of four sessions with palliative care specialists who have been additionally trained to evaluate and address the specific psychosocial issues and health-promoting behaviors of patients with long, uncertain cancer trajectories.
15744995|NCT04900922|Device|isokinetic dynamometer|We will use an isokinetic dynamometer to conduct the fatigue protocol. The subject will perform isokinetic shoulder internal rotation until the internal rotation torque decreases 50% of maximum torque.
15744996|NCT04900909|Device|Aortic Valve Replacement|Surgical replacement of aortic valves
15744997|NCT04900896|Device|Myoelectric Elbow-Wrist-Hand Orthosis|An arm orthosis that uses myoelectric signals to control the level of mechanical assistance provided to a user's elbow and hand in order to overcome upper limb weakness or paralysis and achieve functional tasks.
15744998|NCT04900883|Other|survey|anonymous survey
15744999|NCT04900857|Other|Dry needle|Local twitch responses (LTRs) were obtained by multiple rapid insertions of the needle in and out of the point, similar to Hong's rapid-entry and rapid exit technique. Hong 1994). The needle was not removed from that site for the maximum stimulation time of 1 minute to 3 minutes after a local twitch response was obtained.
15745000|NCT04900857|Device|Localize vibration|the vibration was applied with 110 Hz and 5.57 mm amplitude.
15745002|NCT04900831|Diagnostic Test|Omnipolar Eletroanatomical mapping|Analyse intracardiac EGMs collected with the HD Grid catheter (Abbott, Chicago, IL) during routine Atrial Flutter ablation using the Omnipolar algorithm.
15745003|NCT04900818|Drug|TJ033721|Tetravalent IgG(H)-scFv fusion-type of bi-specific antibody (BsAb)
15745004|NCT04900792|Drug|Ferumoxytol injection|Ferumoxytol is an iron replacement product FDA approved for treatment of iron deficiency anemia in adult patients with chronic kidney disease (CKD). This trial uses the FDA approved dosage (512 mg iron) for iron-deficiency anemia in CKD.
15745005|NCT04900792|Drug|Pharmacological ascorbate|Intravenous ascorbate
15745006|NCT04900792|Radiation|External beam radiation therapy|Photon based, focal radiation therapy delivered consistent with national guidelines, standard for treatment of GBM.
15745007|NCT04900792|Drug|Temozolomide|Temozolomide is a cytotoxic alkylating agent administered orally that penetrates well into the central nervous system. It is a standard-of-care treatment for GBM.
15745008|NCT04900766|Drug|Mitoxantrone Hydrochloride Liposome Injection|20 mg/m2, IV, on day 1 of each 21-day cycle (q3w).
15745009|NCT04900740|Device|Catheter fixation with surgical stitch|The catheter will be fixed using the standard procedure - surgical stitch.
15745010|NCT04900740|Device|Catheter fixation with glue (cyanoacrylate tissue glue Secure PortIV)|The catheter will be fixed using the experimental procedure - novel surgical glue.
15745011|NCT04900727|Other|No intervention|No intervention
15745012|NCT04900714|Procedure|Decremental PEEP|High PEEP to low PEEP.
15745013|NCT04900714|Diagnostic Test|Lung ultrasound score|lung ultrasound to determine the extend of atelectasis. Uses validated lung ultrasound score.
15745014|NCT04900714|Diagnostic Test|Blood gas analysis|Blood gas analysis to determine arterial oxygen tension
15745015|NCT04900714|Diagnostic Test|Registration of respiratory mechanics|Pressures and volumes will be registered by the Fluxmed respiratory monitor (MBMED, Argentina)
15745016|NCT04900714|Diagnostic Test|Evaluation of dead space|Dead space will be measured non-invasively using volumetric capnography on the FluxMed respiratory monitor (MBMED, Argentina)
15745017|NCT04900701|Other|Energy status|Varying conditions of energy intake, thereby manipulating whether participants are in a state of energy restriction, balance, or surplus.
15745018|NCT04900688|Device|LithoVue 2.0|LithoVue 2.0 is a disposable flexible ureteroscope that offer novel pressure sensory capacity
15745019|NCT04900675|Other|Bright light intervention|Exposure with 5,000 lux at eye level for one hour and a Correlated Color Temperature of 5,300 Kelvin every morning for three weeks.
15745020|NCT04900675|Other|Reddish placebo light|Exposure with 50 lux at eye level for one hour and a Correlated Color Temperature of 2,200 Kelvin every morning for three weeks.
15745021|NCT04900649|Other|chest resistance exercise|lung function.
15745022|NCT04900649|Other|chest expansion exercises|thoracic excursion
15745023|NCT04900636|Device|Telemedicine Arm|Patients with DM1 ≥ 18 years of age, users of closed loop hybrid systems, assigned to a follow-up program using a telemedicine platform combined with face-to-face visits according to protocol.
15745024|NCT04900623|Device|NavDx HPV ctDNA Testing|Blood will be collected and shared with an outside lab for analysis. This test will be done at Week 4 and at End of Treatment. This test will be done at at End of Treatment and in follow-up at 3, 6, 9, and 12 months after completing the study treatment. In years 2 and 3 after treatment, the test will be collected every 6 months or twice a year. The specimens will be identifiable. The specimens will be banked for future use.
15745025|NCT04900623|Radiation|Radiotherapy|Radiation Therapy (administered daily, Monday-Friday). Higher risk participants will receive standard radiation dose for up to 7-8 weeks. Lower risk participants will receive a lower dose and treatment will only last 5-6 weeks.
15745026|NCT04900623|Drug|Chemotherapy drug|"Chemotherapy and radiation therapy are both considered standard treatments
~Bolus Cisplatin: Infused every 21 days for up to 2 or 3 doses.
~Weekly Cisplatin or Carboplatin with Paclitaxel: Infused weekly during radiation therapy."
15745027|NCT04900610|Dietary Supplement|MenaQ7 ®, Nattopharma, ASA, Hovik, Norway|daily per os supplementation of 1mg MK-7
15745028|NCT04900597|Other|Elecare Jr|Elecare Jr is a standard pediatric elemental formula
15745029|NCT04900597|Other|Nourish|Nourish is a commercially prepared blenderized tube feed that is formulated for pediatric use
15745030|NCT04900597|Other|Real Foods Blends|Real Foods Blends is a commercially prepared blenderized tube feed that is formulated for pediatric use
15745031|NCT04900584|Other|Checklist|Checklist of guideline-based treatment before discharge
15745032|NCT04900584|Other|Education|Heart failure education before discharge
15745033|NCT04900584|Other|Telephone monitoring|Telephone monitoring after discharge
15745034|NCT04900571|Drug|Nitrofurantoin 100 MG|Comparison of alleviating post-operative pain between nitrofurantoin and calcium hydroxide
15745035|NCT04900558|Procedure|Radical Cystectomy|All the patients enrolled have undergone or will undergo radical cystectomy, with or without lymphadenectomy or urethrectomy All possibles urinary diversion are included, like ileal conduit, neobladder etc...
15745036|NCT04900532|Dietary Supplement|Tocotrienol rich fraction|Supplementation with a Vitamin E compound.
15745037|NCT04900519|Biological|STI-6643|Anti-CD47 human monoclonal antibody
15745038|NCT04900506|Procedure|Posterior SPAIRE approach, anterior approach|Based on power calculation a sub-group analysis of 50 patients will be examined with DXA, all patients for biochemical and clinical muscle damage (CK, CRP, TUG-test, Trendelenburg, strenght test)
15745039|NCT04900480|Other|Direct access to publicly subsidized physiotherapy|This pilot project introduces temporary exemption on the legal required GP referral for public subsidy for treatment in general physiotherapy.
15745040|NCT04900467|Biological|Pfizer|BNT162b2 (Comirnaty®), Pfizer/BioNTech, mARN vaccine,
15745041|NCT04900467|Biological|Moderna|mRNA-1273, COVID-19 Vaccine Moderna, mARN vaccine, administrated by intramuscular
15745042|NCT04900454|Biological|DVX201|Single infusion of DVX201, an allogeneic NK cell therapy derived from CD34+ hematopoietic stem cells
15745043|NCT04900428|Biological|COVI-DROPS|COVI-DROPS is a fully human monoclonal antibody which is a neutralizing antibody to SARS-CoV-2
15745044|NCT04900428|Drug|Placebo|Diluent solution
15745045|NCT04900415|Drug|Vitamin A|Metabolic supplement for neurogenesis at the olfactory apparatus
15745046|NCT04900415|Device|Electronic portable aromatic rehabilitation (EPAR) diffuser|Handheld essential oil ultrasonication diffuser technology
15745048|NCT04900363|Drug|AK112|Subjects receive AK112 intravenously.
15745049|NCT04900350|Drug|AK117|Subjects receive AK117 intravenously.
15745050|NCT04900350|Drug|Azacitidine|Subjects receive Azacitidine subcutaneously.
15745051|NCT04900337|Drug|AMOR 18 Powder & Inhalation|AMOR Inhalation x 3 times a day, via Circulaire® II AMOR Powder x 4 times a day, sublingual
15745052|NCT04900337|Drug|Placebo|Placebo Inhalation x 3 times a day, via Circulaire® II Placebo Powder x 4 times a day, sublingual
15745053|NCT04900324|Device|MRI guidance|Injections of botulinum toxin performed using MRI guidance
15745054|NCT04900324|Device|Ultrasound guidance|Injections of botulinum toxin performed using ultrasound guidance
15745055|NCT04900311|Drug|pyrotinib + trastuzumab + nab-paclitaxel|patients will be treated every 3 weeks for four cycles prior to surgery at following doses: pyrotinib: 400 mg/day, orally, qd trastuzumab: IV infusion on Day 1 every 3 weeks with loading dose of 8 mg/kg in Cycle 1, and 6 mg/kg in Cycles 2-4 nab-paclitaxel: 260 mg/m2 IV infusion on Day 1 every 3 weeks, or 125 mg/m2 IV infusion on Days 1, 8 and 15 every 3 weeks (the nab-paclitaxel administration cycle was determined by investigator at each site)
15745056|NCT04900311|Drug|pertuzumab + trastuzumab + nab-paclitaxel|patients will be treated every 3 weeks for four cycles prior to surgery at following doses: pertuzumab: IV infusion on Day 1 every 3 weeks with loading dose of 840 mg for Cycle 1, followed by 420 mg for Cycles 2-4 trastuzumab: IV infusion on Day 1 every 3 weeks with loading dose of 8 mg/kg in Cycle 1, and 6 mg/kg in Cycles 2-4 nab-paclitaxel: 260 mg/m2 IV infusion on Day 1 every 3 weeks, or 125 mg/m2 IV infusion on Days 1, 8 and 15 every 3 weeks (the nab-paclitaxel administration cycle was determined by investigator at each site)
15745077|NCT04900116|Drug|NaCl 0.9%|In this group, US guided PENG block will be performed with 20 ml %0.9 NaCl solution using a 22 gauge 10 mm block needle (Control Group).
15745078|NCT04900103|Other|ITV-Pal|Use of new technologies for volunteering
15745057|NCT04900298|Device|SafeHaven Automated Hand Hygiene Device|Anesthesia providers in the intervention arm will be given a personal hand hygiene device, containing 64% ethyl alcohol, which provides actionable real-time performance feedback. The personalized device will be affixed to the provider's waist and will remain there for use throughout the perioperative period. Performance feedback is given to the anesthesia provider in real time with the number of personal hand hygiene events and an hourly hand hygiene rate, which is displayed on the device. Devices will be handed out to participating providers in the preoperative bay and retrieved in the post-anesthesia care unit upon case completion.
15745058|NCT04900285|Device|Delta Dental Oral Device|"The oral device is designed to move the genioglossus forward, with interior attachments to maintain the placement of the tongue on the floor of the mouth forward. In addition, bite plates made of the Ethylene-vinyl acetate (EVA) plastic were fabricated and embedded with the mouthpiece to encourage subjects to bite down and push the tongue under the interior lower attachment. The upper plate is made of the same material and slightly opens the bite to improve oral air flow further. The primary component of the mouthpiece is fabricated with Vistamaxx material, which is semi-crystalline 2mm co-polymer that can be molded by the user with Nurse assistance to provide a custom fit.
~The subject will be fitted by moistening and heating in a microwave. Tthe research staff member will assist to ensure proper fit with both the lower and upper dental devices.
~The subject then completes the data collection portion regarding using the SnoreLab app and survey completion as previously described."
15745059|NCT04900272|Behavioral|VIPA and companion booklet|Participants will be asked to use the VIPA and accompanying second iteration of the instructional booklet focused on social-isolation. These participants will be surveyed over the phone for 16 weeks (baseline, 2 weeks, 4 weeks, 8 weeks, and 16 weeks) with outcomes measured at each time point.
15745060|NCT04900259|Behavioral|COVID-19 pandemic|Patients diagnosed with primary bladder cancer by transurethral resection in the urology clinic during and before the COVID-19 pandemic will be retrospectively evaluated and compared.
15745061|NCT04900246|Procedure|Visual Inspection|"The examiners will evaluate the surfaces included in the study independently and without knowledge of the results of the other examiner, after prophylaxis, using a mouth mirror and a WHO probe or Ball point. The evaluations will be carried out in a dental chair with the aid of a reflector. The teeth will be examined moist, and afterwards, they will be dried for 5 seconds with the use of a triple syringe.
~For visual inspection, the International Caries Detection and Assessment System (ICDAS) evaluation system will be used. Complete ICDAS has seven categories, the first for healthy teeth (code 0) and the next two for limited enamel caries, white/brown stain (codes 1 and 2). The following two categories (codes 3 and 4) are considered to be caries that extend to the enamel without exposed dentin. And the two remaining categories (codes 5 and 6), are considered caries with exposed dentin."
15745062|NCT04900246|Radiation|BWX Radiographic Assessment|Participants will be radiographed with a digital X-ray device (DIOX-602, Micro Imagem, Indaiatuba, Brazil) with a regulation of 60 kV and 2 mA and exposure time of 0.10s. The technique used will be the interproximal/bitewing (BWX), with the FIT T1 Digital Sensor (external dimensions: 36.7mm x 24.3mm/sensitive area dimensions: 30.0mm x 20.0mm - 600mm²) and the sockets will be standardized with use of Han-Shin radiographic positioners (Jon, São Paulo, Brazil).
15745063|NCT04900246|Device|Assessment of the iTero Element 5D scan|For scanning, the iTero 5D (Align Technology) equipment featuring NIRI Technology will be used. The Infrared Imaging Technology (NIRI) is a diagnostic tool that allows the detection of interproximal and occlusal caries in several stages, from the initial enamel caries to lesions in the amelo-dentin junction, without the use of ionizing radiation. Infrared is the region of the electromagnetic spectrum between 0.7 and 2.0 micrometers (µm). The iTero Element 5D imaging system uses wavelength light (= 850 nm) in an electromagnetic spectrum that, in interaction with the hard tooth tissue, provides additional data on its structure.
15745064|NCT04900233|Other|surgery|emergency surgery
15745065|NCT04900220|Drug|Betamethasone|The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of betamethasone (6 mg)
15745066|NCT04900220|Drug|Methylprednisolone|The volume of the doses of steroid to be given will be standardized to 1 injection of 1 cc of methylprednisolone (40 mg)
15745067|NCT04900194|Behavioral|mindfulness-based sexual counseling|Mindfulness-based sexual counseling was planned as 2 sessions per week for 4 weeks, in total 8 sessions. Each session lasted 30-40 minutes on average. The sessions were carried out individually by determining the appropriate days of pregnant women in the pregnancy class.In the study, the meditation techniques of the Mindfulness Therapy constituted the backbone/framework of the psychoeducation program. Body and breath, body scanning, mindfulness movement and three-minute respiration techniques were practiced during the psychoeducation program, practically every session in accordance with the researchers' directives.
15745068|NCT04900181|Procedure|the same-day discharge surgery|the same-day discharge surgery is the procedure in which the patient is admitted, operated and discharged within 24 hours.
15745069|NCT04900168|Device|Intracranial pressure monitoring|An invasive method to monitor the intracranial pressure of patient
15745070|NCT04900155|Drug|Atorvastatin 80mg|Initially, hypolipidemic treatment with atorvastatin at a dose of 80 mg / day is prescribed from the first 24-96 hours of myocardial infarction in addition to standard therapy for the disease.
15745071|NCT04900155|Drug|Atorvastatin-Ezetimibe|In the absence of reaching the target level of LDL-C ≤1.4 mmol / L and ≥50% of the initial level after 4-6 weeks from the onset of myocardial infarction, patients additionally receive ezetimibe at a dose of 10 mg 1 time / day.
15745072|NCT04900142|Procedure|Micropulsed laser trabeculoplasty|Trabeculoplasty
15745073|NCT04900129|Combination Product|Menthol 0.02%, Methyl salicylate 0.05%, N- Acetyl cysteine 1.2 gm%, and Diclofenac sodium 1gm%|inhaled vapor containing Menthol 0.02%, Methyl salicylate 0.05%, N- Acetyl cysteine 1.2 gm%, and Diclofenac sodium 1gm% twice daily in addition to conventional treatment. That is, 100 gram of emulsion contain diclofenac sodium 1 gram, N-acetyl cysteine 1.2 gm, menthol 20 mg, and methyl salicylic acid 50 mg.
15745074|NCT04900116|Drug|Bupivacaine HCl 0.5 % in 20 ML Injection|In this group, US guided PENG block will be performed with 20 ml 0.5% bupivacaine using a 22 gauge 10 mm block needle.
15745075|NCT04900116|Drug|Bupivacaine HCl 0.25 % in 20 ML Injection|In this group, US guided PENG block will be performed with 20 ml 0.25% bupivacaine using a 22 gauge 10 mm block needle.
15745076|NCT04900116|Drug|Bupivacaine HCl 0.125 % in 20 ML Injection|In this group, US guided PENG block will be performed with 20 ml 0.125% bupivacaine using a 22 gauge 10 mm block needle.
15745079|NCT04900090|Other|Epidemiological study|"Clinical phenotypic assessment and neurosensory measures
~Biological, genetic and metabolomic evaluation
~Questionnaires (quality of life, gout, life habit, comorbidities)
~Morphological evaluation by Dual-energy CT scan"
15745080|NCT04900077|Device|Carriere® Motion™ Appliance|class II malocclusion corrector
15745081|NCT04900064|Behavioral|Brief interventions|'Brief Interventions' (BI) is a generic term for a multitude of tools and interventions used in patient visits within PCBH. BI start immediately at the initial consultation, which ends with a personally tailored and evidence-informed plan adjusted to the patient's context. As such, there is no separation between assessment and intervention. The interventions within BI often have their foundation in CBT, ACT or Motivational Interviewing (MI). The common theme is that they are principle-based rather than manual-based and focus on behavioural change in relation to a problem, rather than focusing on a specific diagnosis. Follow-up appointments are scheduled flexibly depending on the patient's perceived need. A BI treatment usually consists of 1-4 appointments with several weeks apart and has an open ending, where the patient easily can schedule a new appointment. Clinicians delivering brief interventions will have had 3 days of training as well as regular supervision.
15745082|NCT04900064|Behavioral|Self-help CBT|The patient receives a previously scientifically evaluated CBT-based self-help book for one of the following conditions: depression, generalized anxiety disorder, panic disorder, social anxiety, health anxiety, insomnia, or stress/burnout. The therapist support consists of 3-6 contacts throughout the 6-12 weeks long intervention period as decided by the clinician and patient together, as long as at least one and not more than three are physical visits at the center and the rest via phone, video conferencing, or secure internet messages. Clinicians delivering self-help CBT will need four days of reading and two days of training as well as regular supervision to be able to make initial assessments and problem profiling and use the self-help books.
15745083|NCT04900038|Drug|GSK3640254|GSK3640254 will be available as 25 mg or 100 mg tablets to be administered orally
15745084|NCT04900038|Drug|Dolutegravir|DTG will be available as 50 mg tablets, to be administered orally
15745085|NCT04900038|Drug|Lamivudine capsules|3TC will be available as 300 mg capsules, to be administered orally as a blinded treatment
15745086|NCT04900038|Drug|Lamivudine tablets|3TC will be available as 300 mg tablets, to be administered orally as an unblinded treatment
15745087|NCT04900025|Other|Bright lighting|The bright lighting condition will administer the light intensity as determined from the finding of Study 1. Bright lighting condition will last for two weeks (Weeks 2-3 or 4-5), be limited to the 10 workdays, and be active for 8 hours per day.
15745088|NCT04900025|Other|Placebo lighting|The placebo condition will expose participants to 150 lux, a light level that is equivalent to average room lighting. Placebo lighting condition will last for two weeks (Weeks 2-3 or 4-5), be limited to the 10 workdays, and be active for 8 hours per day. The placebo lighting condition will be applied to minimize the bias and false improvements that might occur due to experiencing new lighting conditions and devices.
15745089|NCT04900012|Procedure|Distal pancreatectomy|We are going to collect all cases
15745090|NCT04899999|Behavioral|Financial reward graphic message|Graphic image will be shared with the participants online once in either English or Spanish depending on their language of preference. Image includes the following text: Vaping leads to nothing. Don't let your money vaporize away.
15745091|NCT04899999|Behavioral|Health reward graphic message|Graphic image will be shared with the participants online once in either English or Spanish depending on their language of preference. Image includes the following text: Dying for a vape? It hurts more than you know.
15745092|NCT04899999|Behavioral|Self-efficacy graphic message|Graphic image will be shared with the participants online once in either English or Spanish depending on their language of preference. Image includes the following text: Vaping companies are targeting Black and Latino teens. Your life matters. Don't let them take it away.
15745093|NCT04899999|Behavioral|Social norms graphic message|Graphic image will be shared with the participants online once in either English or Spanish depending on their language of preference. Image includes the following text: Just because vaping is common, doesn't mean it's cool. Stay woke. Don't smoke.
15745094|NCT04899986|Other|Chlorhexidine and Biorepair gel and toothpaste application|Split-mouth application of chlorhexidine gel 1% (quadrants 1 and 4) and Biorepair Periogel (quadrants 2 and 3) after professional dental hygiene. Home oral care will be continued with chlorhexidine 0,12% gel and Biorepair Periogel in the same quadrants, for the following 15 days from the visits, together with the use of Biorepair Parodontogel toothpaste.
15745095|NCT04899986|Other|Standard oral hygiene|Use of standard toothpastes for home oral hygiene.
15745096|NCT04899973|Behavioral|LEAD IT! programming|LEAD IT! is an intervention that enables persons with dementia to lead activities for their peers. The activities take place on tablets.
15745097|NCT04899960|Drug|Clinical Pharmacist Intervention|Prevention of drug-related problems by clinical pharmacist in neonatal intensive care unit.
15745098|NCT04899934|Behavioral|mobile and technology assisted aftercare|The mobile and technology assisted aftercare consists of mobile mental health professionals who travel to participants to provide mental health services including counseling, navigation of community referrals, motivational interviewing, solution focused therapy, psycho-education, and social support. Participants randomized to this condition will also receive 24/7 access to evidence-based behavioral health mobile applications that are recommended based on the participant's diagnostic status, learning style, and goals. Frequency of app use is up to the participant's discretion. However, during weekly aftercare sessions, the CSS may assist the participant with creation of an app use schedule that is realistic for the participant's needs and treatment goals.
15745099|NCT04899934|Other|Treatment as usual|Treatment as usual services include a personalized discharge plan, a follow up appointment within a month of discharge for evaluation and connection to other agency services if applicable. Some of these services may include outpatient counseling for behavioral and emotional problems, psychiatric services, group therapy, case management, rehabilitation services, homeless recovery services, employment services, medication-assisted treatment, group-based team building activities, primary care clinic, and forensic services. Individuals may also receive ancillary referrals for applicable healthcare services, access to residential and outpatient substance abuse treatment services, and access to a tablet.
15745100|NCT04899921|Drug|Ipilimumab|Intravenous injection
15745101|NCT04899921|Drug|Nivolumab|Intravenously (IV) into the vein
15745102|NCT04899921|Drug|Troriluzole|Taken orally
15745103|NCT04899921|Drug|Placebo|Taken orally
15745107|NCT04899882|Other|KinHémo|Evaluation and cardiovascular training, combination of resistance and flexibility training
15745108|NCT04899869|Other|Faecal microbiota transplantation with active study microbiota first|2x enema with active study microbiota; after 8 wks 2x enema with inactive autoclaved study microbiota
15745109|NCT04899869|Other|Faecal microbiota transplantation with inactive autoclaved study microbiota first|2x enema with inactive autoclaved study microbiota; after 8 wks 2x enema with active study microbiota
15745110|NCT04899869|Other|Faecal microbiota transplantation with inactive autoclaved study microbiota only|2x enema with inactive autoclaved study microbiota; after 8 wks 2x enema with inactive autoclaved study microbiota
15745113|NCT04899830|Device|Telepresence robot|From the application installed on a tablet, the patient hospitalized in a center for a period of at least 2 months can start from the center where he is hospitalized the mobile robotic telepresence assistance device installed at home to communicate with his family, his friends, his neighbors,…)
15745114|NCT04899817|Drug|Granisetron|The drug is given after induction of general anesthesia
15745115|NCT04899791|Other|Wheat bread enriched with hydroxytyrosol|Wheat bread enriched with hydroxytyrosol
15745116|NCT04899791|Other|Wheat bread|Wheat bread
15745117|NCT04899778|Drug|Oral Contraceptive Pill|tablet
15745118|NCT04899765|Biological|BCG vaccine|It is an attenuated live bacterial vaccine. This vaccine is a freeze-dried product that must be reconstituted.
15745119|NCT04899765|Biological|Measles vaccine|It is an attenuated live virus vaccine. This vaccine is a freeze-dried product that must be reconstituted.
15745120|NCT04899765|Other|Placebo|Saline
15745121|NCT04899752|Behavioral|Motivational Interviewing|Participants will participate in three different communication styles to determine the effect of MI on cardiac rehab outcome measures.
15745122|NCT04899739|Diagnostic Test|Echoendoscopy|Peripancreatic lymph nodes and at a distance from the pancreas assessment by endoscopic ultrasound, elastography an doppler to record their anatomical location and characteristics. All lymph nodes suspected of metastatic disease will be marked with sterile black ink.
15745123|NCT04899726|Device|Rectoscope (P201630551)|Rectoscope (P201630551) allows the identification of the distal section margin in oncological rectal surgery.
15745124|NCT04899713|Other|Survival survey|To assess the effect of adding ZOMETA® to neoadjuvant chemotherapy on event-free survival.
15745125|NCT04899700|Device|Linked Color Imaging|Inspection of the postpolypectomy scar will be made with Linked Color Imaging
15745126|NCT04899700|Other|White light endoscopy|Inspection of the postpolypectomy scar will be made with White light Endoscopy
15745127|NCT04899687|Drug|Fluoxetine|Fluoxetine 20mg (or previously prescribed dose) will be taken once daily by mouth for 8 weeks
15745128|NCT04899687|Drug|Dextromethorphan|Dextromethorphan, an over-the-counter cough suppressant, will be taken by mouth twice daily for four weeks of the study, starting at 15mg per dose, and increasing weekly as tolerated to a maximum of 60mg per dose.
15745129|NCT04899674|Drug|Elontril|Elontril
15745130|NCT04899674|Drug|BI 1358894|BI 1358894
15745131|NCT04899661|Drug|Molidustat (Musredo, BAY85-3934)|Tablets, administered orally at the discretion of investigators
15745132|NCT04899648|Behavioral|Behavioral Intervention Group|Behavioral intervention: (a) form groups and choose peer leaders; (b) train peer leaders on 16 core classes based on diabetes prevention program curriculum; (c) support and motivate peer leaders to lead intervention in their group; (d) monitoring of the interventions.
15745133|NCT04899635|Other|In-vitro contractile fatigue protocol|Using contractility assays for muscle slices or the work-loop assay for isolated heart cells, the tissue preparation will undergo a series of contraction and relaxation under varying levels of preload, afterload, stimulation frequency and under other experimental conditions such as drug-induced inotropism.
15745134|NCT04899622|Behavioral|MBSR|Participants will attend weekly online classes (two hours duration) of MBSR for eight weeks. The classes will be delivered live online to groups of up to fifteen participants and will be led by Mindfulness instructors with MSc degrees in Mindfulness Based Interventions. The programme content will be based on the standard MBSR programme and is tailored towards key concerns and difficulties experienced by individuals with chronic pain.
15745135|NCT04899622|Behavioral|Exercise|"Participants will attend weekly classes of supervised classes (1 hour) for eight weeks, following the MBSR class. The exercise class will be delivered live online to the group by an experienced Physiotherapist and will consist of a range of flexibility and strengthening exercises which will be advanced every two weeks for the duration of the eight week programme. The exercises will also be available in video format on the mobile application Physitrack which each participant will be invited to download. This will allow the participants to review the exercises between sessions, record online if they have completed each exercise and in addition rate their pain experience while completing the exercises."
15745136|NCT04899622|Behavioral|Online Self-Management Guide|Participants will receive standard evidence based self-guided information which they will access independently via the members area of the study website. This 'Online Self-Management Guide' will consist of eight categories of self-management; (1) What is chronic pain? (2) Chronic pain and nutrition (3) Sleep issues with chronic pain (4) Activity and exercise (5) Pacing (6) Using a pain diary (7) Relaxation and mindfulness and (8) Course summary. The information will be presented in the form of general text, links to online resources and videos. The information in this area will be updated biweekly during the eight week programme with the participants receiving bi-weekly email reminders.
15745137|NCT04899596|Other|No intervention|No intervention
15745138|NCT04899583|Device|Sirolimus Coated Balloon Catheter|a Sirolimus Coated Balloon Catheter designed and produced by Acotec
15745139|NCT04899583|Device|a Paclitaxel Coated Balloon Catheter|a Paclitaxel Coated Balloon Catheter(trade name:Bingo)
15745140|NCT04899570|Drug|Zanubrutinib|160mg Bid, oral, d1-21 in a 21-day cycle for 8 cycles.
15745141|NCT04899570|Drug|Rituximab|Rituximab 375mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be prescribed as protocol
15745142|NCT04899570|Drug|Cyclophosphamide|Cyclophosphamide 750mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be prescribed as protocol
15745143|NCT04899570|Drug|Epirubicin|Epirubicin 70mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be prescribed as protocol
15745144|NCT04899570|Drug|Vindesine|Vindesine 4mg intravenous infusion d1, every 21 days for 1 cycle. 8 cycles will be rescribed as protocol
15745145|NCT04899570|Drug|Prednisone|Prednisone 60mg/m2 orally d1-5, every 21 days for 1 cycle. 8 cycles will be rescribed as protocol
15745146|NCT04899557|Procedure|Single Port Robotic Splenectomy|Pediatric patient with splenomegaly underwent a single port robotic splenectomy.
15745147|NCT04899544|Behavioral|Center-Based Pivotal Response Treatment (PRT) Intervention (PRT-C)|Pivotal Response Treatment in autism center.
15745148|NCT04899544|Behavioral|Home-Based Pivotal Response Treatment (PRT Intervention (PRT-H)|Pivotal Response Treatment in home environment.
15745149|NCT04899531|Other|Longitudinal observation|No specific intervention, longitudinal (pre-post measurements) only
15745150|NCT04899518|Drug|ALY688 Ophthalmic Solution|Ophthalmic Solution
15745156|NCT04899479|Drug|SGLT2 inhibitor|In patients with AMI and high risk of heart failure, 1:1 randomization will be performed to either SGLT2 inhibitor or control group.
15745157|NCT04899479|Other|Control|In patients with AMI and high risk of heart failure, 1:1 randomization will be performed to either SGLT2 inhibitor or control group.
15745158|NCT04899466|Device|ActiGraft|Whole blood clot (WBC) gel
15745159|NCT04899453|Drug|Methotrexate|400ug intravitreal injection every week for 4 doses in the induction phase, every 2 weeks for 2 doses as consolidation, then every month for 10 doses
15745160|NCT04899453|Drug|Rituximab|Rituximab 375mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 6 cycles will be prescribed as protocol
15745161|NCT04899453|Drug|Zanubrutinib|160mg Bid, oral. 21-day cycle for 6 cycles in the induction phase and for 2 years in the maintenance phase
15745162|NCT04899427|Drug|orelabrutinib|Orelabrutinib will be given as 150mg per day orally, until progression of the disease (PD), unacceptable toxicity, or patient/investigator discretion.
15745163|NCT04899427|Drug|Sintilimab|Sintilimab 200mg intravenous infusion d1, every 21 days for 1 cycle. The medicine will be given until progression of the disease (PD), unacceptable toxicity, or patient/investigator discretion.
15745164|NCT04899427|Drug|Tislelizumab|Tislelizumab 200mg intravenous infusion d1, every 21 days for 1 cycle. The medicine will be given until progression of the disease (PD), unacceptable toxicity, or patient/investigator discretion.
15745165|NCT04899414|Drug|Dexamethasone, azacytidine, Pegaspargase, Tislelizumab|Dexamethasone 40mg intravenously daily on day 1-4; azacytidine 100mg intravenously daily on day 1-5; Pegaspargase 3750 IU intravenously daily on day 1； Tislelizumab 200 mg IV on Day 1 of each 21-day as a cycle.
15745166|NCT04899401|Dietary Supplement|Standard of care + PediaFlù®|Standard of care: Standard of care for acute tonsillitis / rhinopharyngitis is focused on symptomatic treatment. PediaFlù®: During the 6 days of the clinical investigation, the subjects will administer PediaFlù® 5ml x3 times per day for children below 6 years and 10mlx3 times per day for children above 6 years.
15745167|NCT04899401|Other|Standard of care|Standard of care for acute tonsillitis / rhinopharyngitis is focused on symptomatic treatment. Standard of care Nasopharyngeal liberation through hydration with drinking fluids to support body fluid excretion, aspiration of secretions, NaCl solution for nasal irrigation, Nasal sprays with sea water, nasal spray with active compound (to be used only at special indication of the medical doctor) Throat spray with Benzydamine hydrochloride (Tantum Verde®), Pediatric use: children over 6 and below 12: 4 sprays 2 - 6 times a day. Children (under 6 years): 1 spray per 4 kg of body weight, a maximum of 4 sprays at once, 2-6 times a day according to the leaflet. Each spray equals 0.17 ml of solution. Acetaminophen (Paracetamol) per os: at need, as antipyretic (>38,5C), 10 mg/kg/dose, per need every 6-8 hours or according to the leaflet, maximum dosage 80 mg / kg / day. A dosage of over 30 mg/Kg/dose will result in an IP failure;
15745168|NCT04899388|Procedure|Pericapsular Nerve Block|regional anaesthia
15745169|NCT04899388|Procedure|Lumbar Erector Spinae Plane Block|regional anaesthia
15745170|NCT04899388|Drug|Fentanyl|intavenous
15745171|NCT04899375|Device|Floss band|Tissue-flossing, is the use of an elastic band to provide compression on soft-tissue and joints whilst performing active and, or passive range of motion.
15745172|NCT04899375|Device|ACE bandage|An ACE bandage is a cloth wrap used to provide compression
15745173|NCT04899362|Device|BB-RIC-D1/LAPUL Medical Devices Co, Ltd, China|The RIC consisted of 4 cycles of extremities ischemia (5-minute blood pressure cuff inflation to 200 mm Hg, followed by 5-minute cuff deflation). The tourniquets were applied to one side upper arm. This intervention was undertaken twice a day for 7 days.
15745174|NCT04899362|Procedure|Intravenous blood collection|Nurses will collect intravenous blood 3ml four times (at baseline and the first, seventh and eighth day of the study).The blood samples will be stored for laboratory test.The blood samples only use for the trial.
15745204|NCT04899115|Drug|VE303|"Starting the last day of oral vancomycin (Day 1), subjects randomized to this arm will take 5 capsules of VE303 taken daily for 14 days.
~The quantity of each strain is proportioned to assure a specific per-strain per-capsule titer. The 8 strains are blended together with a micro-crystalline cellulose flow agent and placed in enteric capsules."
15745205|NCT04899115|Drug|oral vancomycin|All enrolled subjects will receive 5 days of oral vancomycin 125 mg four times a day (q.i.d).
15745206|NCT04899102|Behavioral|Time-Restricted, Intermittent Fasting|A special type of diet for 6 weeks, called time-restricted, intermittent fasting.
15774938|NCT04655391|Drug|Venetoclax|Given PO
15745175|NCT04899362|Device|dCA measurement|Serial measurements of dCA were performed at 10 days, baseline, 1st, 2ed, 4th, 7th, 8th, 10th, 14th, 21th and 35th of the study.The continuous ABP was measured non-invasively using a servo-controlled plethysmograph (Finometer Pro, the Netherlands) at the middle finger. Two 2 MHz transcranial Doppler probe was used to measure continuous cerebral blood flow velocity (CBFV) simultaneously in the bilateral middle cerebral arteries at a depth of 45-60 mm Endtidal CO2 was monitored using a capnograph (MultiDop X2, DWL, Sipplingen, Germany). The probes were placed over temporal windows and fixed with a customized head frame. CBFV and continuous arterial blood pressure were recorded simultaneously from each subject in the supine position for 10 minutes. All data were recorded for further assessment and analysis.
15745176|NCT04899349|Drug|Alpelisib|Alpelisib (tablets) administered at 300mg orally once daily on a continuous dosing schedule starting on Cycle 1 Day 8 in a 28 days cycle.
15745177|NCT04899349|Drug|Fulvestrant|Fulvestrant (prefilled syringe) 500mg administered intramuscularly at Cycle 1 Day 1 and 15 after randomization and then at Day 1 of each subsequent cycle during the randomized treatment phase.
15745178|NCT04899349|Drug|Metformin XR|Metformin XR (tablets) administered at a starting dose of 500mg orally once daily on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28 days cycle. Dose titration from 500 mg once a day to 2000 mg once a day.
15745179|NCT04899349|Drug|Dapagliflozin + metformin XR|Dapagliflozin + metformin XR administered as a single tablet combination at a starting dose of 5 mg dapagliflozin + 500 mg metformin XR orally once daily on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28 days cycle. Dose titration from 5 mg dapagliflozin + 500 mg metformin XR orally once daily to 10 mg dapagliflozin + 2000 mg metformin XR once daily
15745180|NCT04899349|Drug|Dapagliflozin|Dapagliflozin (tablet) at a starting dose of 5mg orally once daily on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28 days cycle. Dose titration from 5 mg to 10 mg once daily
15745183|NCT04899310|Biological|mRNA-3705|A sterile liquid for injection
15745184|NCT04899297|Other|Questionnaire|All parents of patients visited at an outpatient service dedicated to the treatment of vertebral deformities will be recruited at the end of the medical clinical evaluation. The doctor will invite all subjects to complete the questionnaire anonymously at the end of each follow-up visit.
15745185|NCT04899284|Other|Early Intensive Bimanual Stimulation|Early intensive bimanual stimulation program for infants showing early signs of UCP, delivered by the family environment, in the child's familiar surroundings, under the guidance of a therapist, over a period of 2 months.
15745188|NCT04899258|Procedure|Femtosecond laser assisted LASIK|Refractive surgery
15745189|NCT04899245|Diagnostic Test|BinaxNOW Rapid Antigen System|"BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes.
~The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more."
15745190|NCT04899232|Drug|Antithrombin III|Five total doses of daily 1,821 to 9,100 IUs Antithrombin III, depending on participant's weight, will be administered intravenously every other infusion day (Days 1, 3, 5, 7 and 9).
15745191|NCT04899219|Drug|ACT-1014-6470 40 mg|ACT-1014-6470 will be available as soft gelatin capsules for oral administration formulated at a dose strength of 20 mg.
15745192|NCT04899206|Drug|Antihypertensive Agents|Patients under treatment with Angiotensin Agents.
15745193|NCT04899193|Drug|Pergoveris FD|Participants will be administered with 900 IU of recombinant human follicle-stimulating hormone (r-hFSH) and 450 IU of recombinant human luteinizing hormone (r-hLH) freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in investigation period 1 or investigation period 2 or investigation period 3. There will be a washout period of 6 days between investigation period 1 and investigation period 2 and 17 days between investigation period 2 and investigation period 3.
15745194|NCT04899193|Drug|Pergoveris Liquid|Participants will be administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Pergoveris Liquid) as subcutaneous injection using disposable pen-injector on Day 1 in investigation period 1 or investigation period 2 or investigation period 3. There will be a washout period of 6 days between investigation period 1 and investigation period 2 and 17 days between investigation period 2 and investigation period 3.
15745195|NCT04899193|Drug|Gonal-f|Participants will be administered with 900 IU of folitropin alfa (Gonal-f) as subcutaneous injection on Day 1 in investigation period 1 or investigation period 2 or investigation period 3. There will be a washout period of 6 days between investigation period 1 and investigation period 2 and 17 days between investigation period 2 and investigation period 3.
15745196|NCT04899193|Drug|Luveris|Participants will be administered with 450 IU of lutropin alfa (Luveris) as subcutaneous injection on Day 1 in investigation period 1 or investigation period 2 or investigation period 3. There will be a washout period of 6 days between investigation period 1 and investigation period 2 and 17 days between investigation period 2 and investigation period 3.
15745199|NCT04899154|Other|stool sampling|Participants will provide two stool samples: one collected the day of inclusion and a second, four months later after anti-TNF α or anti- IL-17 (interleukin-17) treatment initiation.
15745200|NCT04899154|Other|stool sampling|Participants will provide one stool sample at inclusion
15745201|NCT04899141|Device|Percutaneous Coronary Intervention|stenting with the ihtDEStiny® sirolimus eluting stent
15745202|NCT04899128|Drug|Pyrotinib|Pyrotinib-based therapy
15745203|NCT04899115|Drug|Placebo|Starting the last day of oral vancomycin (Day 1), subjects randomized to this arm will take 5 capsules of placebo for 14 days taken once daily.
15775616|NCT04649541|Drug|Placebo|5% dextrose in water
15745207|NCT04899089|Behavioral|Cognitive Training|The computerized training exercises and brain games help stimulate cognitive functions while providing real-time monitoring on the evolution of participants' skills.
15745208|NCT04899089|Behavioral|Trivia Training|The computerized trivia training asks participants to answer general questions related to pop culture, science, geography, etc. Participants can use online sources to search for answers and will be provided feedback on their accuracy.
15745209|NCT04899076|Device|Stool Processing Kit|The Stool Processing Kit is a centrifuge-free stool processing solution that allows preparation of stool samples for testing with the Xpert Ultra MTB/RIF assay
15745210|NCT04899063|Device|ELIOS Procedure|Treatment with the ELIOS System
15745211|NCT04899050|Drug|Cannabidiol (Epidiolex)|Use of Epidiolex to control absence seizures.
15745212|NCT04899037|Other|No intervention|This is an observational study of participants that either choose or not choose to utilize an OID. This is not an intervention prescribed study, however, participants may choose uptake of standard of care intervention and obtain and utilize an OID. An OID is an FDA-approved device commonly recommended to patients with conductive, mixed, or singled-sided hearing loss. There is no experimental intervention evaluated in this study.
15745213|NCT04899024|Behavioral|PARTI|PARTI will provide positive affect skills. Each 1-hour session delivered via Zoom consists of a didactic portion with in vivo skills practice and participants are asked to complete home practice of the skills between sessions. Many sessions include formal exercises that have been utilized in Mindfulness-Based Relapse Prevention to cultivate mindfulness and meta-cognitive awareness.
15745214|NCT04899024|Behavioral|Attention-Control|Attention-Control will provide a core set of coping and affect measures as well as neutral writing exercises. Each 1-hour attention-control session will be administered via Zoom.
15745215|NCT04899024|Behavioral|Contingency Management for PrEP Adherence|Participants will complete a 12-week contingency management protocol via their smartphone that consists of uploading brief videos taking PrEP medications up to four times per week. Total possible contingency management incentive for completing 48 observed PrEP doses is $360.
15745216|NCT04899011|Other|Questionnaire|"Questionnaire about taste and salivary disturbance before surgery, 10 days, 4 months and 1 year after surgery.
~Questionnaires include characteristics of taste disturbance, and specific impact on quality of life."
15745217|NCT04898998|Device|Transcutaneous electrical nerve stimulation (TENS)|Surgical patients under general anesthesia were recruited from a medical center. Each patient was randomly assigned to the experimental group (TENS) or control group (routine care).
15745218|NCT04898998|Other|routine care|routine care
15745219|NCT04898985|Diagnostic Test|ImmunoSEQ|experiment assay
15745220|NCT04898972|Behavioral|Mindfulness-based stress reduction intervention|The 8-group sessions of MBSR will be conducted once a week, lasting two and a half hours, with two additional sessions in the following two months. Between sessions, participants will have to practice at home for 45 minutes a day, 6 days a week. For the practice, patients and caregivers will be provided with audio files containing the meditations proposed in the classroom, readings, and the diary of the practice. During the sessions, the following mindfulness-based techniques will be introduced: body scan; sitting meditation; awareness movement exercises; and walking meditation.The sessions will be held face to face or online using common videoconferencing platforms, such as Skype or Zoom, based on the preferences of the participants. This will facilitate the participation of patients and caregivers, overcoming the obstacles related to travel. The course will be taught by certified mindfulness teachers with experience in MBSR interventions on patients with respiratory diseases.
15745221|NCT04898972|Behavioral|Information on stress reduction|"COPD patient-caregiver dyads will be delivered by hand, sent by email or by post an information booklet Coping with your chronic disease, targeting COPD patients, to teach them how to manage stress. This booklet, available in Italian, provides simple information on the meaning of stress and anxiety, and suggests some actions that people can implement at home to reduce stress."
15745222|NCT04898959|Other|Filling out Questionaire|Filling out the Arabic Activity Specific Balance Confidence (A-ABC) and the Arabic Prosthetic Mobility Questionnaire twice at 2-3 week intervals
15745223|NCT04898946|Biological|CoronaVac Vaccine|CoronaVac Vaccine
15745224|NCT04898946|Biological|BNT162b2 Vaccine|Covid-19 BNT162b2 Vaccine
15745225|NCT04898933|Procedure|eyelid lesion excision|eyelid lesion excision was done under local anesthesia
15745226|NCT04898920|Drug|Normal saline|The patients will receive 10 ml of normal saline as a placebo dexamethasone before surgery.
15745227|NCT04898920|Drug|Dexamethasone|Those patients will receive 16 mg dexamethasone in 10 ml of normal saline before surgery.
15745228|NCT04898907|Drug|ANG-3777 (Therapeutic Dose)|Arms assigned to this intervention will receive 2 mg/kg, IV, Fasted
15745229|NCT04898907|Drug|ANG-3777 (Supra-therapeutic Dose)|Arms assigned to this intervention will receive 6 mg/kg, IV, Fasted
15745230|NCT04898907|Drug|Placebo|Arms assigned to this intervention will receive normal saline, IV, Fasted
15745231|NCT04898907|Drug|Moxifloxacin Hydrochloride|Arms assigned to this intervention will receive 400 mg, Oral, Fasted
15745232|NCT04898894|Drug|Venetoclax|Given orally (PO)
15745233|NCT04898894|Drug|Selinexor|Given Orally (PO)
15745234|NCT04898894|Drug|Cytarabine|Given in to the vein (IV) or intrathecal (IT)
15745235|NCT04898894|Drug|Fludarabine|Given in to the vein (IV)
15745236|NCT04898894|Biological|Filgrastim|Given subcutaneous (SubQ, SC)
15745237|NCT04898894|Drug|Methotrexate|Given intrathecal (IT)
15745238|NCT04898894|Drug|methotrexate/hydrocortisone/cytarabine|Given intrathecal (IT)
15745239|NCT04898881|Other|Breast Human Milk|Interventional drug is given to the neonates 2 minutes before the heel lance
15745240|NCT04898881|Other|24 % Sucrose|0.5 ml of sucrose given once 2 minutes prior to procedure
15745241|NCT04898868|Procedure|cord blood spontaneous drainage|In women allocated to groups of cord blood spontaneous drainage, two clamps will placed at 4 finger breadths from the infant's abdomen and cut between two clamps after delivery of the baby. The clamp on the placental site will be removed and the drainage time and amount of cord blood to a measuring glass will be recored.
15745265|NCT04898686|Biological|Placebo chewables|chewables without probiotic strain. Ingredients: Xylitol, microcrystalline cellulose, stearic acid, natural orange flavor, silica, magnesium stearate, citric acid and malic acid.
15745266|NCT04898673|Device|CP1110|Sound Processor
15745242|NCT04898868|Procedure|Umbilical cord miking|In women allocated to groups of cord milking group, two clamps will placed at 4 finger breadths from the newborn's abdomen and cut between two clamps immediately after delivery of the baby. The clamp on the placental site will be removed, then the umbilical cord will be squeezed several times, 5 seconds between each squeezing, to collect cord blood in a measuring glass. The number of cord milking and the volume of blood collected will be recorded.
15745243|NCT04898855|Behavioral|Cognitive Behavioral Therapy for Insomnia|Treatment includes sleep hygiene, sleep restriction, stimulus control, and cognitive therapy.
15745244|NCT04898842|Other|Dietary intervention|To determine whether a 4 stage bowel obstruction diet as a means of managing oral intake in patients symptomatic with malignant sub-acute bowel obstruction (SBO) is deliverable and effective in clinical practice.
15745246|NCT04898816|Procedure|closure of wound using n- butyl 2-octyl cyanoacrylate tissue adhesive|Application of cyanoacrylate tissue adhesives over the surgical wound
15745247|NCT04898816|Procedure|closure of wound using braided silk suture|suturing the surgical wound using braided black silk
15745248|NCT04898803|Other|conventional DGVS training|see above
15745249|NCT04898803|Other|extended simulator training|see above
15745250|NCT04898790|Behavioral|CHAMPS-II adapted to adults 60+ years in HCT setting|CHAMPS-II is an evidence-based physical activity program designed to increase physical activity in sedentary older adults with multiple chronic health conditions. This is an individually tailored program that provides information, skills, training, and problem-solving support to older adults. Participants will engage in progressive, light to moderate-intensity physical activity throughout the HCT process, with the support of physical therapists, physical activity counselors, and their care-partner. They will take part in supervised exercise sessions; unsupervised exercise sessions; counseling sessions to address barriers, motivators, goals, and safety; and receive telephone support. Walking is the primary mode of aerobic activity, with training in flexibility, strengthening and balance exercises also included. An exercise kit will be provided, consisting of an intervention workbook, therapeutic resistance bands, and activity logs.
15745251|NCT04898790|Other|Survivorship education active control|Participants receiving the survivorship education program will receive a workbook of education materials, and participate in individual and/or small group education sessions on topics important to HCT survivors; assignments intended to provide reinforcement of education via practical and engaging activities; and telephone contacts for support and reinforcement of materials. Participants will be encouraged to choose topics of interest to them for additional focus, to enhance participation.
15745252|NCT04898777|Procedure|Biliary drainage|Biliary decompression in cases of distal malignant obstruction by stent placement either using ERCP or EUS.
15745253|NCT04898764|Drug|Mometasone Furoate|Mometasone furoate nasal spray suspension, 50µg/actuation
15745254|NCT04898751|Drug|Immune checkpoint inhibitor (ICI)|Immune checkpoint inhibitors included were targeting either PD-1, PD-L1 or CTLA-4, and had received FDA approval at the time of study (ATC classification): Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32), and Cemiplimab (L01XC33).
15745255|NCT04898738|Other|Alcohol based hand sanitizer|Provision of ABHS to randomly selected households
15745256|NCT04898725|Dietary Supplement|Vitamin D3|Vitamin D3 4800IU daily
15745257|NCT04898712|Drug|Tranexamic Acid 500 MG|Tranexamic Acid 500mg oral tablets
15745258|NCT04898712|Drug|Placebo|The placebo will consist of an identical capsule to over-encapsulated tranexamic acid oral tablet entirely filled with microcrystalline cellulose, and sealed.
15745259|NCT04898699|Device|UrSure Rapid Urine Tenofovir Test|A point of care urine immunoassay to measure PrEP drug levels for adherence in participant urine samples over the preceding seven days will be done at all follow-up visits. At enrollment, study staff will explain the use of this experimental measurement of PrEP drug level in urine samples. Participants will receive results of the test at the same study visit during which it is performed.
15745260|NCT04898699|Device|OraQuick Rapid HIV Self-test kit|Participants will be provided with HIV self-testing kits to use at their discretion and, in case of multi-month dispensing, prior to start of new bottle of PrEP medication, in between study visits. HIV self-testing kits will be provided to confirm their HIV-negative status and make a connection between PrEP use and protection against HIV. Participants will receive detailed, interactive training on HIVST with pictorial elements, including instructions to contact study staff immediately in event of a reactive test for confirmation as per Kenya guidelines.
15745261|NCT04898699|Drug|Tenofovir (300mg)/Emtricitabine(200mg) [Truvada®]|Information will be provided regarding dosing of PrEP medications, importance of daily adherence, importance of frequent HIV testing, and signs and symptoms of drug toxicity, acute HIV infection and STIs. An initial one-month supply (30 pills) of FTC/TDF will be given to all PrEP study participants. At the one-month study assessment, a two-month supply of daily oral FTC/TDF will be given to each participant, after HIV testing, assessment for acute HIV infection and review of side effects and adherence, following national guidelines and procedures for PrEP services. At Month 3 assessment, a three-month supply of oral FTC/TDF will be given.
15745262|NCT04898699|Behavioral|2-way text message reminders|"All participants will receive weekly SMS visit reminders to support PrEP adherence. Participants will be asked at study enrollment for a primary contact telephone number and an alternate number for contact. Participants without cell phones will be provided an inexpensive cell phone (although cell phone ownership is very high in Kenya). Participants will receive a discrete weekly SMS text (or voice message if participant is illiterate) to encourage healthy behaviors, use of HIV self-test kit, study engagement and PrEP adherence. Messages will be a general message that the participant has selected and will not have any information identifying the participant as part of the study or describing the purpose of the study. An example text is Remember to look after yourself today, See you tomorrow. Participants will be requested to respond to the message with any questions, concerns or messages that they have for the study staff."
15745263|NCT04898699|Behavioral|HIV risk-reduction counseling|All study participants will be provided with brief interactive counseling at each study visit, tailored to the results of their urine assay.
15745264|NCT04898686|Biological|Probiotic chewables|chewables containing Lacticaseibacillus rhamnosus GG
15745268|NCT04898647|Other|fundoscopic picture|A central review of numerised fundoscopic picture will be performed.
15745269|NCT04898647|Biological|blood sample|"Two 10 ml blood vials will be sampled in addition to standard blood sampling for getting 6 to 7 200 μL aliquot.
~One 5 ml EDTA vial for GP1bα expression study, only if this sample can be sent to hemostasis laboratory within the 4 hours after sampling"
15745270|NCT04898647|Procedure|bone marrow sample|Five to 10 ml bone marrow sample will be collected in addition to standard bone marrow sampling for getting molecular characteristics of WM
15745271|NCT04898634|Drug|JNJ-78278343|JNJ-78278343 will be administered subcutaneously.
15745272|NCT04898621|Dietary Supplement|75g fructose solution|Subjects will drink a bottle of 350 ml solution containing 75g fructose per day for 4 weeks.
15745273|NCT04898621|Dietary Supplement|150g fructose solution|Subjects will drink a bottle of 700 ml solution containing 150g fructose per day for 4 weeks.
15745274|NCT04898608|Other|Intradialytic Exercise|"Participants will do concurrent exercise (a combination of aerobic exercise and resistance training) for 30-60 minutes during the second hour of their routine hemodialysis sessions.
~To determine the intensity of the prescribed exercise, maximum heart rate is used for aerobic workout and 1RM for resistance protocols.
~Exercises will be performed at a moderate exercise intensity (12-14 on the Borg RPE Scale).
~All protocols are tailor-made based on each individual's needs and physical abilities."
15745275|NCT04898595|Procedure|Discontinuation of CRRT|Discontinuation of CRRT will be guided by an algorithm based on patient current condition.
15745276|NCT04898582|Other|Mineral 89 Probiotic Fractions|The subjects applied the product M89 Probiotic Fractions on half a face, twice a day, in the morning and in the evening, for 30 days. They put two drops of the product in the palm of their hand and gently massage with their fingertips on half face. The face skin had to be cleaned and dried before the application of the product. The subjects used their standard skin care product on the side of the face not treated with M89 Probiotic Fractions
15745277|NCT04898569|Drug|Ferinject|Ferric carboxymaltose injection
15745278|NCT04898569|Drug|Normal Saline Flush|placebo
15745279|NCT04898556|Drug|Prasterone 6.5 MG|The dose to be applied will be one Intrarosa ovule (Prasterone 6.5mg) a day before going to bed for 12 weeks.
15745280|NCT04898556|Other|Placebo|Patients with a diagnosis of VVA who will not undergo treatment for 12 weeks.
15745281|NCT04898543|Biological|M-CENK, Suspension for Infusion, Cryopreserved (M-CENK)|M-CENK will be administered 4 times via intravenous (IV) infusion on days 1, 8, 15 and 22. The dose of MCENK will be 0.25 - 0.75 × 10e9 cells per infusion.
15745282|NCT04898543|Biological|N803|N803 15 μg/kg will be administered subcutaneously on days 1 and 15.
15745283|NCT04898543|Other|Apheresis collection of lymphocytes (part A)|Subjects in cohort 1 will participate in apheresis collection of lymphocytes (part A) and will not receive any investigational therapy in this study.
15745284|NCT04898530|Other|NO INTERVENTION|There is no intervention for this study.
15745285|NCT04898517|Procedure|Pancreaticoduodenectomy with the CONDUCTJE-ST technique|"The termed technique connexion pancreatic duct to the jejunum stented (CONDUCTJE-ST) in pancreaticoduodenectomy is a novel technique, modification of the pre-existing ones, whose effectiveness lies in the fact that it is not an anastomosis in the strict sense but rather a simple connection for restoring pancreatic juice flow from the pancreatic remnant towards the intestine."
15745286|NCT04898504|Drug|Floxuridine|A laparotomy will be performed and a catheter placed in the hepatic artery Connected to a subcutaneous pump. This pump will be percutaneously filled with Floxuridine 6 times in 2 weeks cycles, alternating with heparin-solution.
15745287|NCT04898504|Procedure|Liver Transplantation|Patients randomized to this arm will be given 2nd line chemotherapy (regimen given at the discression of the treating oncologist) followed by liver-Tx
15745288|NCT04898491|Other|Pain assessment using a behavioral scale|"The pain of the subjects will be evaluated by two independent observers and with a blind result between them, coinciding with the application of two painful procedures used in routine practice: suction of tracheal secretions and the pressure in the nail bed by means of a pressure algometer. In addition, a painless procedure will also be performed to establish an element of control with the procedures painful. This will consist of the application of gentle friction with a cloth gauze, on a part of healthy skin tissue of the patient. The measurement will be performed twice for each patient and procedure depending on the level of sedation, so that the first measurement will be performed with a deeper sedation level and the second with a change in sedation level to moderate-mild.
~In turn, the pain assessment will be carried out in three moments: first or baseline measurement, during the application of the painless and 15 minutes after finishing the procedures."
15745289|NCT04898478|Behavioral|Treatment Seeking Intervention for Pacific Islanders with Opioid Use Disorders|The investigators will design a culturally grounded treatment seeking intervention for Pacific Islanders with OUDs
15745290|NCT04898465|Other|Social Paediatric Intervention|Family will meet the hospital's social-paediatrician and social worker. Together they will evaluate the need for social support, risk for neglect and refer families for local social services if needed. The visit will contain primary and secondary prophylaxis of child abuse and neglect.
15745291|NCT04898452|Other|A new model of interaction across health services with use of welfare technology and telemedicine|Instead of admitted to the hospital, patients are followed up at home by the municipal regional response center and nurses in the response team according to the individual treatment plan. Hospital physicians are medically responsible throughout the course.
15745292|NCT04898439|Other|greening of the school environment|The school will be greened and biodiversity will be increased. This will be done on the playground and area around the school. Special needs corners for playing, relaxing or gardening will be installed.
15745293|NCT04898426|Other|Enhanced bowel preparation instruction|Automated delivery of SMS, pre-recorded phone call, and link to an information website.
15745294|NCT04898413|Behavioral|Group-based acceptance and commitment therapy (ACT)|Group-based ACT intervention by professional psychotherapist consists of four modules: (a) psychoeducation about dementia and experiential avoidance in caregiving, (b)mindfulness and acceptance of aversive emotions, sensations, and thoughts, (c) behavior management for care recipients' BPSD, and (d) clarifying and choosing one's value, and taking actions toward the chosen values. Each session lasts about 90 minutes and will be held every two weeks. Group-based reminiscence therapy for care recipients will be conducted by a professional psychotherapist other than the one conducting group-based ACT intervention.
15745295|NCT04898413|Behavioral|Group-based cognitive behavioral therapy (CBT)|Group-based CBT intervention by professional psychotherapist consists of four modules: (a) psychoeducation about dementia and distress in caregiving, (b) cognitive restructuring and relaxation, (c) behavior management for care recipients' BPSD, and (d) increasing pleasant activities. Each session lasts about 90 minutes and will be held every two weeks. Group-based reminiscence therapy for care recipients will be conducted by a professional psychotherapist other than the one conducting group-based CBT intervention.
15745296|NCT04898400|Procedure|endoscopy sleeve gastroplasty|endoscopic procedure for weight loss
15745297|NCT04898387|Combination Product|Bimatoprost Timolol (T4030)|Eye drop
15745298|NCT04898387|Combination Product|Bimatoprost Timolol (Ganfort)|Eye drop
15745299|NCT04898374|Drug|Gemcitabin/cisplatin|chemotherapy combination
15745300|NCT04898361|Procedure|PFO closure|Interventional closure of a patent foramen oval preceded by an electrophysiological study
15745301|NCT04898348|Drug|Vancomycin Pre-Treatment|Four times per day dosing of Vancomycin pre-treatment
15745302|NCT04898348|Drug|KBL697|3 capsules twice a day dosing of KBL697
15745303|NCT04898348|Drug|Placebo|3 capsules twice a day dosing of Placebo
15745304|NCT04898335|Device|Tendyne Mitral Valve System|Tendyne Mitral Valve System for mitral valve disease in a commercial setting
15745305|NCT04898322|Drug|SY-005|2.5mg of SY-005 for each dose，doses to be given every 12 hours over a period of 5 days
15745306|NCT04898322|Drug|SY-005|5mg of SY-005 for each dose，doses to be given every 12 hours over a period of 5 days
15745307|NCT04898322|Drug|SY-005|10mg of SY-005 for each dose，doses to be given every 12 hours over a period of 5 days
15745308|NCT04898322|Drug|Placebo|Placebo
15745315|NCT04898296|Other|Questionnaire, Interview|During the stay, a study visit is arranged with the patient after the 6-minute walk test has been performed. This consists of filling out the questionnaire and an interview, which lasts about 45-60 minutes. This is carried out by the investigator on at least 5 subjects. After each interview, a list of influencing factors is kept. If new aspects continue to appear in the 5th interview, the interviews are continued (up to a maximum of the 10th subject). If no new aspects appear in the interviews from number 6 onwards, the interviews are discontinued and no further patients are recruited. The conversations are recorded with an audio recording.
15745316|NCT04898296|Other|Focus Group|The focus group is carried out first in order to identify influencing variables that may be relevant for the interview (duration 60-90 minutes).
15745317|NCT04898283|Biological|10,000 MG01 +10,000 T521|Purified and polymerized with glutaraldehyde allergen extract, from a mixture of grasses (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca pratensis, Lolium perenne and Dactylis glomerata) and cupresaceae (Juniperus oxycedrus), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections
15745318|NCT04898283|Biological|30,000 MG01 +10,000 T521|Purified allergen extract polymerized with glutaraldehyde, from a mixture of grasses (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca pratensis, Lolium perenne and Dactylis glomerata) and cupresaceae (Juniperus oxycedrus), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections.
15745319|NCT04898283|Other|Placebo subcutaneous|The same solution and presentation as the active treatment, but without active ingredients
15745320|NCT04898270|Drug|Flupentixol|"Flupentixol tablets are indicated for:
~• maintenance therapy of chronic schizophrenic patients whose main manifestations do not include excitement, agitation, or hyperactivity."
15745321|NCT04898270|Drug|Multi-acting receptor-targeted antipsychotics (MARTAs)|Multi-acting receptor-targeted antipsychotics (MARTAs)
15745322|NCT04898257|Dietary Supplement|Multistrain probiotic|After completion of screening phase, during baseline visit, eligible patients will be assigned to Lactibiane Tolerance® 10 billion CFU 1 capsule twice a day on an empty stomach (30 minutes before breakfast and 30 minutes before dinner).
15745323|NCT04898231|Drug|Infliximab|Infliximab will be administered as a single IV dose of 10 mg/kg over 2 hours.
15745324|NCT04898231|Drug|Anakinra|Anakinra will be administered at a dose of 8 mg/kg/day IV or SQ with 100 mg every 6 hours as the max dose. This is discontinued with a taper during the hospitalization over 2-4 days once a patient is stable with significantly improved clinical course and laboratory profile.
15745325|NCT04898231|Drug|Methylprednisolone|Methylprednisilone (steroids) will be administered as 2 mg/kg IV or orally divided every 12 hours. At the time of hospital discharge the patient will be given a steroid taper that will take at least 3 weeks to complete.
15745326|NCT04898218|Other|Exercise|The exercises were performed for 12 weeks, for the maximum of 6 days/week for Osteoanabolic group, 5 days/week for aerobic group and 3 days/ week for a resistance group as per ACSM, FITT protocol.
15745327|NCT04898205|Other|Treadmill Exercise|The cardiopulmonary rehabilitation protocol utilizes progressive treadmill exercise with alternating increases in intensity and incline with no more than 0.5 Met increase per session.
15745328|NCT04898205|Other|Concentrated Oxygen|Supplemental oxygen from a concentrator (6 liters per minute) will be provided via nasal cannula regardless of oxygen saturation.
15745329|NCT04898205|Other|Concentrated Air|Room air will be delivered through an concentrator provided via nasal cannula.
15745330|NCT04898192|Other|questionnaire|questionnaire - the complex of 6 questionnaires aimed to recognize the fear of delivery, perinatal anxiety, depressive disorder, obsessive-compulsive disorder, general anxiety disorder, postpartal depression and domestic violence.
15745642|NCT04895306|Drug|Testosterone Cypionate|Weekly intramuscular administration of testosterone at a dose of 3 mg
15745331|NCT04898179|Other|Telecare Group|"Home-based telehealth program: telenursing and specialist teleconsultation
~Telemonitoring with a new pulse oximeter and specific App
~E-health platform
~Videoconference"
15745332|NCT04898179|Other|Control group|Usual care
15745333|NCT04898153|Device|aXess|Patients will be implanted with one Xeltis hemodialysis access device (aXess) in the arm
15745334|NCT04898140|Diagnostic Test|SARS-CoV-2 specific IgM and IgG detection|Detection of IgM and IgG antibodies specific to the SARS-CoV-2 antigens in the blood serum using enzyme-linked immunosorbent assay (ELISA).
15745335|NCT04898140|Diagnostic Test|ELISpot: detection of the T cells specific to different SARS-CoV-2 proteins|Detection of peripheral blood T lymphocytes which are activated and secrete interferon gamma (IFNgamma) upon stimulation with peptides, covering the immunodominant sequence domains of the nucleocapsid N, membrane M, or spike glycoprotein S proteins of SARS-CoV-2 coronavirus.
15745336|NCT04898140|Diagnostic Test|Flow cytometry: detection of the SARS-CoV-2 specific T-helpers and cytotoxic T lymphocytes|Detection of peripheral blood T-helpers (CD45+CD3+CD4+)* and cytotoxic T cells (CD45+CD3+CD8+)* which are activated and secrete IFNgamma and/or interleukin-2 (IL2) upon stimulation with mixture of peptides, covering the immunodominant sequence domains of the nucleocapsid N, membrane M, and spike glycoprotein S proteins of SARS-CoV-2 coronavirus. * CD, cluster of differentiation
15745337|NCT04898127|Diagnostic Test|SARS-CoV-2 antigen rapid test|Rapid test before access to mass gathering event (concert), provided the test result is negative.
15745338|NCT04898114|Drug|Magnesium sulfate|Nebulized magnesium sulfate (4 ml of 6.4% solution) every 15 minutes
15745339|NCT04898114|Drug|Sildenafil Citrate|Oral sildenafil citrate at an initial dose of 1 mg/kg, with incremental increases by 0.5 mg/kg every 6 hours till reaching a target dose of 2mg/kg every 6 hours.
15745340|NCT04898114|Other|Isotonic saline|Nebulized isotonic saline (4 ml) every 15 minutes
15745341|NCT04898101|Drug|Acalabrutinib|Participants in Cohort 1 will receive a single 100 mg oral capsule dose of acalabrutinib on Day 1.
15745342|NCT04898101|Drug|Microtracer [14C]ACP-196|Participants in Cohort 1 will receive a single microtracer (<10 μg; ≤1 μCi) IV solution dose of [14C]ACP-196 as a 5-mL IV push over 2 minutes on Day 1. Participants in Cohort 2 will receive a single 100 mL dose of acalabrutinib 1 mg/mL oral solution containing a microtracer dose (<10 μg; ≤1 μCi) of [14C]ACP-196 on Day 1.
15745343|NCT04898088|Biological|Mesenchymal Stem Cells Transplantation|Mesenchymal Stem Cells Transplantation applied as three intravenous infusions with 30 days intervals
15745344|NCT04898075|Behavioral|Remote Contingency Management (CM) for nicotine abstinence|Participants will be paid increasing amounts of payment for each negative saliva cotinine test.
15745345|NCT04898075|Other|Control|Participants will be paid for providing saliva nicotine test, regardless of whether the test is positive or negative.
15745346|NCT04898062|Device|CRP-apheresis|The major advantages of depleting C-reactive protein by therapeutic apheresis are the selective removal of the damaging agent by the highly specific ligand and the good controllability of the procedure, since the plasma can be passed over the column as often as necessary to achieve the desired reduction. In addition, treatment can be interrupted or discontinued at any time.
15745347|NCT04898036|Device|Blue Light Therapy|This phototherapy device (PTD-1) consists of a Plexiglas hand compartment (cleanable) enclosed in a powder-coated steel cabinet. Within the cabinet are two blue LED panels located above and below the hand compartment to illuminate the hands.
15745348|NCT04898036|Device|Sham Light Therapy|To turn the device into a sham mode, a thin opaque liner can be inserted which will block light from illuminating the hands.
15745349|NCT04898023|Drug|zinc-green tea extract-ascorbic acid|Compounded capsules
15745350|NCT04897997|Procedure|coronarography and angioplasty|selective angiography of the coronaries and angioplasty of significant culprit lesion(s)
15745351|NCT04897984|Biological|Liver-enriched antimicrobial peptide 2|IV infusion of LEAP2, 2 hours
15745352|NCT04897971|Diagnostic Test|Medium enriched for newly synthesized antibodies in spine infection|Medium enriched for newly synthesized antibodies titers in patients with Staphylococcus aureus infections of orthopedic spine implants at baseline and in the post operative period
15745353|NCT04897958|Drug|Degarelix|Degarelix dispensing claim is used as the reference group.
15745354|NCT04897958|Drug|Leuprolide|Leuprolide dispensing claim is used as the exposure group.
15745356|NCT04897932|Device|RS - WP06|Ad hoc use of handheld urinal
15745357|NCT04897919|Drug|dihydroartemisinin-piperaquine|D-P is given as recommended by manufacturer and compared to the A-L group.
15745358|NCT04897906|Behavioral|Education Group|Mother care, newborn care and breastfeeding education will be provided to pregnant women in the third trimester of pregnancy.
15745359|NCT04897893|Other|Eicosapentaenoic acid monoglycerid (MAG-EPA)|MAG-EPA is an omega-3 fatty acid classified in canada as a Natural Health Product (NHP). The NHP is approuved under the Natural Health Product number (NPN # 80050187).
15745360|NCT04897880|Drug|Panobinostat|Panobinostat capsules, 10mg, starting at a de-escalated dose of 8mg/m2 per day
15745361|NCT04897867|Device|CoolSculpting® Elite System with CoolSculpting® Elite applicators|A treatment session is comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage.
15745362|NCT04897854|Drug|Folfirinox|In both arms the intervention will be FOLRINIOX or nab paclitaxel in combination with gemcitabine per investigator's choice
15745363|NCT04897841|Drug|Liposomal bupivacaine|20 mL prior to closing fascia, the active drug (bupivacaine) is encapsulated in a liposomal platform and released slowly over the course of days with an approximate 72 hour duration.
15745364|NCT04897841|Drug|Bupivacaine Hydrochloride|30 mL bupivacaine hydrochloride 0.25 percent, local post-surgical anesthetic
15745365|NCT04897841|Other|saline|post-surgical saline
15745366|NCT04897828|Device|Covered Stent placement|Covered stent placement for the treatment of dysfunctional vascular access of hemodialysis patients
15775652|NCT04649216|Drug|[14C]PCO371|[14C]PCO371 Oral solution
15745367|NCT04897802|Drug|Experimental: GLP1-RA (exenatide) administration|a single dose of 10 mcg of GLP-RA (exenatide) will be administered subcutaneously and samples to assess OT secretory patterns will be collected over 2 hours
15745368|NCT04897802|Drug|Control: Placebo administration|Sodium Chloride 0.9% will be administered subcutaneously at equivalent volume than 10 mcg of exenatide
15745371|NCT04897763|Drug|89Zr-TLX250 PET/CT|Pretherapeutic 89Zr-TLX250 PET/CT
15745372|NCT04897750|Combination Product|CT001|Sufentanil 0.5 mcg/kg + ketamine 0.5 mg/kg as nasal spray, followed by an additional dose 10 -15 minutes after, if needed.
15745373|NCT04897737|Behavioral|HIVST and enhanced adherence biofeedback|"The intervention includes the provision of an OraQuick HIV self-test (HIVST) for the woman and one test for each of her reported sex partners, along with instructions on how to use and interpret the results. Women were asked to report back within one month if their partner was able to test via a SMS, WhatsApp or by bringing in the test to confirm that he had tested.
~Women then received adherence based feedback following the urine lateral flow assay (that measures recent tenofovir use in past 48 hours). Study counsellors requested that women provide a urine sample that was tested using the UrSure/Orasure test that provides feedback on the result in 2-3 minutes. Counselors provided counseling based on the results including how to improve daily adherence (for women without tenofovir present in their urine) and importance of condom use."
15745374|NCT04897737|Diagnostic Test|Orasure/UrSure test|See above
15745375|NCT04897724|Other|dental composite|clinical performance of composite restorations used for posterior teeth in patients with Amelogenesis Imperfecta
15745376|NCT04897711|Behavioral|Perceptual Training|Each listener is familiarized/trained with a single speaker with dysarthria. Pretest/posttest transcription data will be used to build explanatory models of intelligibility improvement.
15745377|NCT04897698|Dietary Supplement|LB001|Probiotics
15745378|NCT04897685|Behavioral|Flow with Nature|Nature-based intervention was facilitated by a health care professional and included 12 x 90 mins sessions within 12 weeks.
15745379|NCT04897672|Other|Observational study|Observational study
15745380|NCT04897646|Other|SFRMS/SPLF CPAP-telemonitoring diagnosis/therapeutic algorithm.|"In 2020, a working group from the Société Française de Recherche et de Médecine du Sommeil (SFRMS) and the Société de Pneumologie de Langue Française (SPLF) have proposed a CPAP-telemonitoring diagnosis/therapeutic algorithm for newly treated patients with obstructive sleep apnea.
~The algorithm is exhasutively described in the following published article: Prigent, A., Gentina, T., Launois, S., et al. [Telemonitoring in continuous positive airway pressure-treated patients with obstructive sleep apnoea syndrome: An algorithm proposal]. Rev. Mal. Respir., 2020, 37: 550-560."
15745381|NCT04897633|Device|transcranial electric stimulation|Simon's task assessment when under tDCS
15745382|NCT04897620|Other|Scanning the blood test results|"Participants' age, gender, duration of low back pain (days), if evaluated, conditions associated with low back pain in cases with subacute/chronic pain, ESR, CRP, RDW, MPV, neutrophil count, lymphocyte count, eosinophil count and platelet count in blood tests at admission examinations were recorded. NLR was calculated by dividing the number of neutrophils by the number of lymphocytes, PLR by dividing the number of platelets by the number of lymphocytes, ELR by dividing the number of eosinophils by the number of lymphocytes, and SII by the formula platelet numberxneutrophil number/lymphocyte number"
15745385|NCT04897594|Drug|TERN-201|Investigational drug
15745386|NCT04897594|Other|Placebo|Matching placebo
15745387|NCT04897581|Behavioral|Brief Behavioral Therapy for Insomnia, BBTI|BBTI includes sleep hygiene, stimulus control, and sleep restriction, and is administered in three 50-minute sessions over telehealth by psychologic team.
15745388|NCT04897581|Behavioral|Physical Self-Regulation, PSR|PSR is conducted over telehealth and consists of three 50-minute sessions focused on jaw relaxation exercises, proprioceptive awareness training, and diaphragmatic breathing entrainment.
15745389|NCT04897568|Other|Patient decision aid|Each subject will receive an informational flyer describing lung cancer screening options and smoking cessation from a trained person on the medical staff at each clinic. Staff will lead a shared decision-making discussion with the patient.
15745390|NCT04897555|Device|LLLT|This is a low-level light (LED) device configured in the shape of a headband, operating at 650 +/-10 nanometers and 940 +/- 10 nanometers, that contains 12 of each wavelength for a total of 24 LEDs.
15745391|NCT04897542|Drug|Gallium-68 NODAGA-JR11|Each patient receive a single intravenous injection of Gallium-68 NODAGA-JR11 (40ug/150-200MBq) PET/CT, and undergo PET/CT scan at 40-60 min post-injection.
15745392|NCT04897516|Drug|Short regimen of benznidazole|Benznidazole, under the brand name Abarax (100 mg and 50 mg tablet), 300 mg divided into two daily doses (150 mg every 12 hours) for 2 weeks.
15745393|NCT04897516|Drug|Standard treatment with benznidazole|Benznidazole, 5mg/Kg/day or fixed 300-400 mg doses/day, orally for 8 weeks based on historical controls
15745422|NCT04897243|Behavioral|Patient Experience|To capture and integrate the patient experience, this study will collect patient-reported experience measures, conduct qualitative interviews, and engage patients as well as providers.
15745394|NCT04897503|Drug|Riboflavin|Corneal epithelium removed followed by riboflavin drop administration (riboflavin/dextran -vs- riboflavin/methylcellulose) every 2 minutes for 30 minutes followed by UV light exposure with additional riboflavin administration every 2 minutes for 30 minutes. Subjects will be randomized to receive either the riboflavin/dextran solution or the riboflavin/HPMC solution.
15745395|NCT04897490|Other|Evaluation of first line treatment with ATO/ATRA outcome|Evaluation of first line treatment with ATO/ATRA outcome (o event free survival and overall survival and toxicity) in adult patients with APL.
15745396|NCT04897477|Drug|Azacytidine, Bendamustine and Piamprizumab|Azacytidine by means of subcutaneous injection, Bendamustine and Piamprizumab intravenous infusion
15745397|NCT04897464|Other|BGaze therapy Alzheimer|BGaze Therapy is an interactive eye tracking game
15745398|NCT04897451|Other|questionnaire|EQ5D-5L questionnaire self-reported 3 months after delivery
15745399|NCT04897438|Procedure|Kidney allograft biopsy depending on donor-derived cell-free DNA levels|Kidney allograft biopsy is performed, when absolute levels of donor-derived cell-free DNA are above 50 copies/ml
15745400|NCT04897425|Device|Mindful SensoriMotor Therapy Enhanced with Brain Modulation|"Hardware and software for myoelectric pattern recognition and sensory training developed at the Center for Bionics and Pain Research.
~tES by Neuroelectrics"
15745401|NCT04897412|Drug|CBL-514|CBL-514 will be administered via injection into the abdominal subcutaneous adipose layer.
15745402|NCT04897412|Other|Placebo|Sodium Chloride (0.9% NaCl) will be administered via injection into the abdominal subcutaneous adipose layer.
15745403|NCT04897386|Drug|Duvalizumab|Pemetrexed 850 mg, IV, Day1; Platinum 50mg / m2, IV, day1, once every 3 weeks, duvalizumab treatment, 1500mg, day1, a total of 4 cycles, once every 3 weeks. 4 cycles in total
15745404|NCT04897360|Behavioral|Increased breathing|hyperventilation to lower ETCO2
15745405|NCT04897360|Other|sharpened Romberg test (SRT)|Balance test conducted by standing with feet in front of each other, heel-to-toe in line while the right hand is on the left shoulder and the left hand is on the right shoulder.
15745406|NCT04897347|Device|Robotic Trunk-Support-Trainer (TruST)|"This will involve tailoring the level of postural assistance via force fields and systematically introduce postural task-progression across training sessions. Age-appropriate activities, including toys and games, will be used in training.
~- Twelve 2hr training sessions (3 times per week for 4 weeks)"
15745407|NCT04897347|Device|Static Trunk Support|"This will involve static support for the trunk via a trained therapist. Age-appropriate activities, including toys and games, will be used in training.
~- Twelve 2hr training sessions (3 times per week for 4 weeks)"
15745408|NCT04897334|Device|tDCS|tDCS is a type of non-invasive brain stimulation in which small electrical currents are applied to the scalp via 2 electrodes. During sham stimulation, the current, 1.5 mA, will be delivered for a short amount of time and then turn-off. To deliver the current, electrodes that are placed in saline soaked sponges. They will be attached to the left side of your head; they will be held in place with an elastic cap. For both real and sham stimulation the electrodes will be placed on the scalp. Most people cannot tell the difference between real and sham stimulation.
15745409|NCT04897334|Device|sham tDCS|tDCS is a type of non-invasive brain stimulation in which small electrical currents are applied to the scalp via 2 electrodes. During sham stimulation, the current, 1.5 mA, will be delivered for a short amount of time and then turn-off. To deliver the current, electrodes that are placed in saline soaked sponges. They will be attached to the left side of your head; they will be held in place with an elastic cap. For both real and sham stimulation the electrodes will be placed on the scalp. Most people cannot tell the difference between real and sham stimulation.
15745410|NCT04897334|Behavioral|Cognitive Therapy|During both the treatment and the sham intervention, participants will undero cognitive therapy training by performing a 2Back task. In this sequential letter memory exercise participants are presented with sequential stimuli in the form of a series of letters. For each new stimulus they are asked to indicate if the current stimulus matches the stimulus from 2 trials prior. This exercise stimulates cognitive demand in working memory, executive function and attention and is correlated with dorsolateral prefrontal cortex activity.
15745411|NCT04897321|Drug|Fludarabine|Fludarabine phosphate is a synthetic purine nucleoside analog. It acts by inhibiting DNA polymerase, ribonucleotide reductase and DNA primase by competing with the physiologic substrate, deoxyadenosine triphosphate, resulting in inhibition of DNA synthesis. Intravenous
15745412|NCT04897321|Drug|Cyclophosphamide|Cyclophosphamide is a nitrogen mustard derivative. It acts as an alkylating agent that causes cross-linking of DNA strands by binding with nucleic acids and other intracellular structures, thus interfering with the normal function of DNA. Intravenous
15745413|NCT04897321|Drug|MESNA|Mesna is a synthetic sulfhydryl (thiol) compound. Mesna contains free sulfhydryl groups that interact chemically with urotoxic metabolites of oxaza-phosphorine derivatives such as cyclophosphamide and ifosfamide
15745414|NCT04897321|Drug|B7-H3 CAR T cells|The study participant will receive B7-H3-CAR T cells by vein, through either an IV or a central line.
15745415|NCT04897308|Procedure|Local injection of shoulder joint|Under ultrasound guidance , local shoulder joint injection will be done
15745418|NCT04897282|Diagnostic Test|UCRI|Biomarker panel and algorithm
15745419|NCT04897269|Procedure|Progesterone supplementation|This procedure is to add more progesterone on those who have low progesterone levels on the day of embryo transfer
15745421|NCT04897243|Drug|Biktarvy|B/F/TAF (Biktarvy®) is a fixed-dose combination of bictegravir (50 mg), emtricitabine (200 mg), and tenofovir alafenamide (25 mg), administered orally, once daily, without food requirements. Participating patients will receive the medication free of charge.
15745643|NCT04895306|Drug|Placebo|Weekly intramuscular administration of Placebo
15745423|NCT04897230|Behavioral|Hatha Yoga|The yoga poses were chosen for providing a restorative session based on their purported relationship to restorative effects to best promote cardiac autonomic recovery from mental stress.
15745424|NCT04897230|Behavioral|Video Watching|The video was about the history of the Earth which encompasses the development of the planet Earth from its formation to the present day.
15745425|NCT04897217|Drug|Megestrol Acetate|The control arm will consist of oral progesterone therapy (megestrol acetate 160mg po daily). The intervention will be administered on an outpatient basis.
15745426|NCT04897217|Drug|Levonorgestrel Drug Implant|Participants in the comparison arm will have a levonorgestrel intrauterine device placed in the office or in the operating room if the office procedure not tolerated or if they have not had a prior dilation and curettage.
15745427|NCT04897204|Procedure|Catheter ablation and left atrial appendage occlusion|The patients underwent routine pulmonary vein isolation and linear ablation and left atrial appendage occlusion.
15745428|NCT04897204|Procedure|Additional left atrial appendage electrical isolation combined with catheter ablation and left atrial appendage occlusion|These patients underwent routine pulmonary vein isolation and linear ablation and left atrial appendage occlusion, combined with additional left atrial appendage occlusion.
15745429|NCT04897191|Other|Age|Determination of age-dependence
15745430|NCT04897178|Diagnostic Test|Ultrasound|Routine 2 dimensional Ultrasound used to screen fetuses for congenital anomalies
15745431|NCT04897165|Other|Resilience training with mobile HRV-BfB based on an e-learning approach (with digital lectures)|A 4-week resilience training with a mobile HRV-BfB device. Participants received access to three online lectures at the start of the first, third, and forth training week (each lasting 60 minutes) to receive a theoretical base on resilience and to learn how to exercise with the HRV-BfB device. Participants were asked to exercise three times a day for 5 minutes in their occupational and leisure time with the HRV-BfB device.
15745432|NCT04897165|Other|Resilience training with mobile HRV-BfB based on a blended learning approach (with live lectures)|A 4-week resilience training with a mobile HRV-BfB device. Participants attended three live lectures at the start of the first, third, and forth training week (each lasting 90 minutes) to receive a theoretical base on resilience and to learn how to exercise with the HRV-BfB device. Participants were asked to exercise three times a day for 5 minutes in their occupational and leisure time with the HRV-BfB device.
15745433|NCT04897139|Drug|Flu-Bu-Mel-E|fludarabine 150mg/m2, busulfan 9.6mg/kg, melphalan 100mg/m2 and etoposide 800mg/m2
15745434|NCT04897126|Drug|MUSK Pill|On the basis of routine treatment, MUSK Pills were added to 4 capsules / day, 3 times per day until the end of follow-up.
15745435|NCT04897126|Drug|Placebo|Placebo
15745436|NCT04897113|Procedure|plasma exchange with albumin|plasma exchange with albumin, two per week, 110% of the circulating plasma volume
15745437|NCT04897113|Procedure|plasma exchange without albumin|plasma exchange without albumin, two per week, 110% of the circulating plasma volume
15745438|NCT04897100|Procedure|Achilles tendon tenotomy|Achilles tendon tenotomy during Ponseti treatment for clubfoot
15745439|NCT04897087|Other|patient safety event|This study will explore the perceptions of patients, carers and relatives who have experienced a patient safety event. Telephone interviews will be undertaken lasting up to 60 minutes This study involves NHS patients, their carers or relatives. We will ask participants about their experience of being involved a patient safety event and the barriers and enablers to participation in the review. We will ask what 'good' patient involvement in patient safety reviews should look like from those with lived experience. This is because we wish to understand from their perspective what matters to them when things go wrong and how best to involve them.
15745441|NCT04897048|Procedure|Incremental exercise test (IET)|Incremental cardio pulmonary exercise test until exhaustion
15745442|NCT04897048|Procedure|Constant work rate exercise test (CWRET)|constant (on 75% Wmax) cardio pulmonary exercise test until exhaustion
15745443|NCT04897035|Device|Dayspring Active Wearable Compression System|Dayspring Active Wearable Compression System
15745444|NCT04897022|Drug|Pembrolizumab|Fixed dose of pembrolizumab 200mg IV q3 weeks
15745445|NCT04897022|Radiation|IMPRINT|The starting radiation dose will consist of 400cGy x5 fractions. Doses will be escalated by 100cGy per fraction (i.e. 400cGy, 500cGy, 600cGy) for a total of 3 dose levels. The MTD will be evaluated using a modified Continuous Reassessment Method. Dose limiting toxicities (DLTs) are defined as any treatment-related non-hematologic toxicity with a CTCAE v5 Grade ≥3 or grade ≥2 pneumonitis that requires use of steroids occurring after the start of IMPRINT through the first 3 months after the last fraction.
15745446|NCT04897009|Procedure|Biospecimen Collection|Undergo blood and tissue collection
15745447|NCT04896996|Dietary Supplement|whole eggs|whole eggs
15745448|NCT04896996|Dietary Supplement|yolk-free egg substitutes|yolk-free egg substitutes
15745450|NCT04896957|Behavioral|Interview|Face to face semi-directed interviews about perceptions, representations and experiences of Covid-19 vaccination, including six opened-questions
15745451|NCT04896944|Other|No intervention|No intervention
15745452|NCT04896918|Behavioral|Tobacco use|
15745453|NCT04896905|Other|Rehabilitation|Rehabilitative procedures in isolation ward
15745454|NCT04896879|Behavioral|interviews|semi-structured interviews will be conducted in patients with major LARS and their informal caregiver to explore their experiences and needs. Focus groups will be perfomed with healthcare professionals of several professions.
15745468|NCT04896736|Other|Usual care|Usual care in this study means the standard perioperative care. Patients who are meant to receive usual care will receive both cerebral and muscular tissue oxygen saturation monitoring; however, the monitor screen will be covered and the monitoring data will not be used to guide clinical care.
15745469|NCT04896723|Diagnostic Test|Sexual function questionnaire|Sexual function questionnaire and cognitive screening assessments
15745470|NCT04896710|Device|SD Biosensor|Nasal swab SD biosensor to be self administered
15745471|NCT04896697|Drug|XTX101|XTX101 monotherapy
15745456|NCT04896853|Biological|ProTrans®|Allogeneic Wharton's jelly (WJ) Mesenchymal Stromal Cells
15745457|NCT04896840|Other|Telerehabilitation İntervention, Motor learning|"Telerehabilitation İntervention:
~Training videos will be sent to the families of the children in the tele-rehabilitation group before starting to work. With the training videos, it is aimed to teach the exercises to be done to the families. Treatment will be applied by their families for 8 weeks, 2 days a week, 40 minutes a day. Physiotherapist will attend the sessions by video conference method. Video conference calls will be made by phone over the WhatsApp application.
~Motor learning:
~The first 10 minutes will start with active stretching Functional lying in a sitting position, Functional lying with feet together in a standing position. rolling the pilates ball on the wall, walking on its side. Going up and down stairs at different heights. Walking across different surfaces and obstacles. Getting up from chairs of different heights, sitting and extending the object taken from the ground. Functional exercises suitable for the child's level."
15745458|NCT04896827|Other|Conditioned pain modulation test|Conditioned pain modulation (CPM) protocol consist of evaluating pain during a heat test, before and after one conditioning stimulus (cold water bath); 3 cameras will be capturing participants' facial expressions during the tests.
15745459|NCT04896814|Procedure|Transcutaneous tibial nerve stimulation|The participant will be placed in the supine position with the soles of the feet together and the knees flexed and abducted at 90º. Two adhesive electrodes will be used for each leg. First one: 32 mm of diameter that will be placed in the posterior tibial nerve, that is, 4-5 cm cranial to the internal malleolus, between the posterior edge of the medial border of the tibia and the soleus tendon. Second one: 50x50 mm to be placed in the ipsilateral calcaneus. The electrodes will be connected to the NeuroTracTM PelviTone stimulation device. The stimulation range will be selected according to the tolerable pain limit for the patient, between 0.5 and 20 mA (adjustable in 1 mA levels).The intensity elevation will be allowed each time the patient perceives the fading of the previous sensation due to accommodation. Under no circumstances should the stimulation cause a painful feeling.
15745460|NCT04896814|Procedure|Placebo|The participant will be placed in the same position. Two 50 x 50 mm adhesive electrodes will be placed on the external face of the thigh, on a single leg. This area is outside the territory of the posterior tibial nerve. A discontinuous current at 2Hz frequency and a pulsed frequency of 50 µs, with 2 seconds of work and 10 seconds of pause will be applied. This simulated current being considered to be insufficient to achieve therapeutic effects in the body and to be outside of the usual ranges described in electrotherapy manuals regarding pain management. The intensity will be selected according to the paint limit level of the patient, between 0.5 and 60 mA (adjustable in 0.1 mA levels), where a low or moderate sensation of the patient will be sought, without muscle contraction.
15745461|NCT04896801|Radiation|MR-guided RT|The dose to the planning target volume (PTV) is 36 Gy (5 x 7.2 Gy) prescribed on the 90% isodose line. The clinical target volume (CTV) is receiving 40 Gy (5 x 8 Gy = 100%). A simultaneous integrated boost (SIB) up to a total dose of 42 Gy (5 x 8.4 Gy = 105%) is delivered to the gross tumor volume (GTV), if present. In addition, relative sparing of the urethra will be applied by avoiding hotspots (V40 Gy < 1cc) in the urethra. Baseline and adapted treatment plans are generated using intensity-modulated RT
15745462|NCT04896788|Biological|Monitoring of the immune response|Blood sample at 3,6,12,18 and 24 months in order to assess the blood level of anti-S1 / RBD anticoprs
15745463|NCT04896775|Behavioral|NiteCAPP CARE|4 session Web-based Cognitive Behavioral Therapy for Insomnia. Individualized sessions moderated by therapist.
15745464|NCT04896775|Behavioral|NiteCAPP SHARE|4 session Web-based Sleep Hygiene and Related Education. Individualized sessions moderated by therapist.
15745465|NCT04896749|Other|Nerve mobilization|"Moist pack all over cervical spine for 10 minutes. Cervical traction for 10 minutes with 7 sec hold and 5 sec rest time. Cervical isometric exercises with 7 sec hold and 25 repetitions in each direction twice a day.
~Median, ulnar and radial nerve stretch with 3 sets of 10 repetitions , with 3 sec hold at final stretched position.
~Following nerve mobilizations are used in experimental group/group A:
~Median Nerve: Glenohumeral abduction, wrist extension, supination, glenohumeral lateral rotation, elbow extension, neck lateral bending to opposite side. Radial Nerve: Glenohumeral depression, elbow extension, whole arm internal rotation, wrist flexion Ulnar Nerve: Wrist extension, forearm pronation elbow flexion, glenohumeral lateral rotation, glenohumeral depression, shoulder abduction each with 3 sets of 10 repetitions , with 3 sec hold at final stretched position."
15745466|NCT04896749|Other|Conventional physical therapy|Moist pack for 10 minutes. TENS for 15 minutes at frequency of 60 Hz with 2 electrodes. Cervical traction for 15 minutes with 7 sec hold and 5 sec rest time. Cervical isometric exercises with 7 sec hold and 30 repetitions in each direction twice a day.
15745467|NCT04896736|Other|Multisite tissue oxygenation-guided care|"The following intervention algorithm is intended to be used as a guidance only. We emphasize the different aspects that can cause changes in SctO2/SstO2 in a systematic approach. We avoid recommending a concrete drug and method of dosing for a specific condition.
~Manage tissue perfusion Preload: overall picture including direct observation of the heart, findings of echocardiography, urine output, blood loss, labs results, HR, BP, PPV, SVV, fluid responsiveness (SV increase >/= 10% following 250 ml fluid bolus) Contractility: direct observation of the heart, findings of echocardiography Stroke volume and heart rate: important determinants of CO Systemic vascular resistance: important determinant of BP Regional vascular resistance: important determinant of tissue perfusion along with perfusion pressure Maintain autoregulation: normalize CO2, avoid potent vasodilators
~Manage arterial blood oxygen content
~Manage tissue metabolic activity"
15745472|NCT04896684|Biological|blood and intestinal biopsy sampling|24 mL of blood and 10 intestinal biopsies will be sampled
15745644|NCT04895293|Drug|RBM-007 Injectable Solution|Sterile solution
15745473|NCT04896671|Behavioral|Physical exercise (running on a treadmill)|Participants in the intervention group join a total of 12 treadmill running sessions, two sessions per week and each session for 30 minutes. In each session, every participant will be trained to run for 30 minutes on a treadmill. According to Exercise and Sports Science Australia (ESSA) exercise intensity guidelines, the intensity of running is suggested to be moderate and vigorous (alternating between the two) in this study.
15745474|NCT04896658|Drug|Belantamab Mafodotin, Cyclophosphamide and Dexamethasone|Study drug
15745476|NCT04896632|Drug|INE 963|Part A: Single ascending dose with 4 planned cohorts> Part B: multiple dose with 1 planned cohort q24x3 days
15745477|NCT04896632|Other|Placebo|Part A: single ascending dose with 4 planned cohorts. Part B: multiple dose with 1 planned q24x3 days.
15745478|NCT04896619|Other|Kori tofu bread|34.5 grams of Kori-tofu, mixed in 3 slices of wheat bread.
15745479|NCT04896619|Other|Whey protein bread|Matched whey protein, soy oil and maltodextrin/cellulose, mixed in 3 slices of wheat bread
15745480|NCT04896606|Other|Standard of Care|Patients will receive standard of care for COVID-19.
15745481|NCT04896606|Biological|SARS-CoV2-CTLS|Patients may receive up to 5 CTL infusions to treat SARA-CoV-2 in combination with standard of care.
15745483|NCT04896580|Behavioral|Nature based exercise|Participants will engage in three months of moderate intensity PA, consisting of three 50-minute walking sessions per week (5-minute warm-up, 40 minute walk, 5 minute cool-down and stretch) with an exercise physiologist for 12 weeks.
15745484|NCT04896567|Diagnostic Test|Cell isolation|Tissue from kidney biopsy will be used to isolate Cluster Differentiation 34+ cells.
15745485|NCT04896554|Behavioral|Health literacy scale|"The Turkish version of The European Health Literacy Survey (HLS-EU) Health Literacy Questionnaire scale (ASOY-TR) was used to measure health literacy. This scale consists of 47 questions. Each item has 4 degrees such that 1 = Very difficult, 2 = Difficult, 3 = Easy, 4 = Very easy. Code 5 is used for the expression I don't know. The total score that can be obtained from the scale is between 47-188. For the sake of ease of calculation, the total score is standardized with the following formula to take a value between 0-50.
~Formula = Index = (arithmetic mean-1) x [50/3] High score means better health literacy."
15745486|NCT04896541|Biological|AZD7442 300 mg IM(male)|Single dose of 300 mg of AZD7442 or saline placebo on Day 1.
15745487|NCT04896541|Biological|AZD7442 600 mg IM (male)|Single dose of 600 mg of AZD7442 or saline placebo on Day 1.
15745488|NCT04896541|Biological|AZD7442 300 mg IV (male and female)|Single dose of 300 mg of AZD7442 or saline placebo on Day 1.
15745489|NCT04896541|Biological|AZD7442 1000 mg IV (male)|Single dose 1000 mg of AZD7442 or saline placebo on Day 1.
15745490|NCT04896528|Drug|Avatrombopag|"Participants meeting the eligibility criteria receive Avatrombopag treatment (orally, 60 mg/day), for a maximum course of 20 days.
~Investigation product withdrawal: PLT ≥75×109/L or increases by at least 50×109/L from the lowest value after targeted therapy and immunotherapy combination treatment."
15745491|NCT04896515|Dietary Supplement|Supplemental parenteral nutrition|Supplemental parenteral nutrition OLIMEL N12E (Baxter Healthcare Corporation)
15745492|NCT04896502|Behavioral|Standard of Care Education|Education regarding recognition and removal of in-home asthma triggers
15745493|NCT04896502|Other|Interactive Video (IAV) Telemedicine|Interactive video assessment of asthma triggers in the home.
15745494|NCT04896489|Drug|Hydrocortisone 20 MG|Participants receive Hydrocortisone 20 MG
15745495|NCT04896489|Other|Placebo|Participants receive placebo
15745496|NCT04896476|Device|EchoMark|The EchoMark is to be secured a minimum of 3 cm away from the anastomosis.
15745497|NCT04896463|Radiation|Abdominal ultrasound (US)|abdominal examination with US device
15745498|NCT04896450|Procedure|Guided tissue regeneration (GTR)|GTR is handled with the utilization of a coronally advanced flap, followed by a thorough debridement of the denudated root surface and the intrabony component. Regenerative materials are resorbable collagen membrane (BioGide, Geistlich Phara AG, Wolhusen, Switzerland) and deproteinized bovine bone mineral (BioOss, Geistlich Phara AG), finally surgery is finished with multilayer suturing technique.
15745499|NCT04896450|Device|Orthodontic tooth movement (OTM)|An early initialization of the tooth movement with the help of a multibond fixed orthodontic device utilizing low level of continuous orthodontic forces.
15745500|NCT04896437|Procedure|non-centrifuge fat graft application to the wounds|Autologous fat grafts were harvested from abdominal or gluteal regions of the patients and injected into the wound bed and wound environment. Clinical observation and photograph records were used to follow the wounds.
15745501|NCT04896424|Procedure|cryoballoon-based pulmonary veins isolation|A cryoballoon is introduced to the LA via a steerable sheath following a single transseptal puncture. The balloon is advanced toward the PV ostium and inflated. PV occlusion is documented by the injection of contrast. Optimal vessel occlusion is assumed when the PV showes complete contrast retention without any backflow to the atrium. The freezing time is chosen between 180 and 240s and left at the operator's discretion, along with a decision if to follow with a bonus-freeze cycle. The application is aborted and the cryoballoon is repositioned in the case of ineffective cooling or when the nadir temperature decreases < -60°C, to avoid excessive cooling. In cases where a real-time recording of PV potentials is available a short time-to-isolation<60s resultes in a single 180s freeze cycle. CBA always startes from the left upper PV (LUPV) followed by the left lower PV (LLPV).
15745502|NCT04896411|Other|Alternative phrasing for no code|This intervention will use the alternative phrase noted in the literature when discussing code status. This will be the only intervention, and all other aspects of trial participation will be collection of data
15745503|NCT04896411|Other|Standard of care for no code|This intervention will use the standard of care phrase noted in the literature when discussing code status. This will be the only intervention, and all other aspects of trial participation will be collection of data
15745504|NCT04896398|Device|ESWT|In the study group, a total of 5 sessions of focused ESWT (1000 shock, 1.6 bar, 5 Hz) will be applied to the affected wrist within 2 weeks.
15745505|NCT04896385|Drug|Ruxolitinib cream|Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
15745506|NCT04896385|Drug|Vehicle Cream|Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
15745507|NCT04896372|Other|ACT comprehensive of standard care|"The proposed intervention was designed by the authors of the study. It was developed following the main ACT-based manuals, with adjustments according to the users and the context of the study implementation.
~Specifically, we developed a practical and interactive intervention, which comprises practical activities such as roleplay and writing activities and imaginative activities supported by metaphors. The sessions are based on the use of age-appropriate language to convey the most complex therapeutic processes easily. According to Strosahl and colleagues' model, sessions will respectively target the components of openness, awareness, and engagement."
15745508|NCT04896372|Other|TAU only|adolescents will be assessed by a staff dietician and placed on an individualized hy-pocaloric balanced Mediterranean diet. They will also follow a nutritional counselling aimed at promoting the adoption of a healthy lifestyle. Moreover, they will attend a physical activity program consisting of five training sessions per week lasting one hour each with trainers; In addition, they will be involved in psychological counselling pro-vided once a week by a clinical psychologist, aimed to address psychological factors related to dysfunctional lifestyle habits.
15745509|NCT04896359|Dietary Supplement|Vitamin C|12.5 grams of ascorbic acid
15745510|NCT04896359|Other|Placebo|vehicle
15745511|NCT04896346|Other|Punch biopsy|punch biopsies will be used for histologic analysis and biochemical assays
15745512|NCT04896346|Other|non-invasive photography, assessments, and measurements|photography, scar questionnaires, pain and itch assessments, and non-invasive measurements of scar including color, stiffness, and elasticity
15745514|NCT04896320|Drug|Tucatinib|Tucatinib is a highly selective, oral, reversibly Her2 small molecule tyrosine kinase inhibitor (TKI).
15745516|NCT04896294|Combination Product|Hygienic procedure (toothbrushing using HAP-containing toothpaste)|Toothbrushing using standardised technique and pear-sized amount of HAP-containing toothpaste twice daily for 1 month.
15745517|NCT04896294|Combination Product|Hygienic procedure (toothbrushing using Zn Mg HAP-containing)|Toothbrushing using standardised technique and pear-sized amount of Zn Mg HAP-containing toothpaste twice daily for 1 month.
15745518|NCT04896294|Combination Product|Hygienic procedure (toothbrushing using FAP-containing toothpaste)|Toothbrushing using standardised technique and pear-sized amount of FAP-containing toothpaste twice daily for 1 month.
15745519|NCT04896281|Dietary Supplement|Phenylalanine-free milk|Intervention protocol Phenylalanine-free milk will be fed for 3 days after enrollment. The milk is purchased from ABBOTT company. The content of the whole nutrition for a daily need is also personalized based on the calculation by our dieticians. After the completion of the study, diet will be back to normal diet for all patients.
15745520|NCT04896268|Device|Radiofrequency|Rafaelo's technique consists of delivering a low-temperature 4 MHz radiofrequency wave current into the haemorrhoidal vascular tissue using a large single-use needle with microfibre electrodes at the end.
15745521|NCT04896268|Device|Arterial ligation then recto-anal repair with Doppler|"The aim of arterial ligation is to de-arterialise the haemorrhoids by reducing the arterial flow of the haemorrhoidal plexuses while avoiding obstructing the venous return."
15745522|NCT04896255|Drug|peginterferon alpha based regimen|peginterferon alpha based regimen or nucleos(t)ide alone are decided by patients' doctors according to their conditions, instead of extra interventions brought by the study
15745523|NCT04896255|Drug|nucleos(t)ide|peginterferon alpha based regimen or nucleos(t)ide alone are decided by patients' doctors according to their conditions, instead of extra interventions brought by the study
15745524|NCT04896229|Other|Talk STEM Familia Treatment Condition|This study has one intervention and two arms: experimental and treatment as usual. Participants randomized to the treatment condition will receive the TSF technology in addition to the vocabulary instruction, monitoring, or resources delivered by English Language Development programs (ELD) and schools. TSF will deliver frequent, brief, dual-language exercises to help families learn, practice and apply SAV words in conversation. Audio-visual lessons will support learning at all literacy levels, regardless of prior familiarity with STEM subjects. The complete TSF tool will contain approximately 72 minutes of video modeling and 12 hours of interactive exercises delivered over 24-weeks in brief, interactive, easy to assimilate lessons.
15745525|NCT04896216|Behavioral|Stigma Reduction Intervention|Care providers will complete the Stigma Reduction Intervention curriculum.
15745526|NCT04896203|Procedure|rotational thromboelastometry|Viscoelastometric method useful to study the kinetics of clot formation and fibrinolysis, providing a global information of both the cellular component and the pro and anticoagulant proteins, as well as the interactions between both components.
15745527|NCT04896190|Other|Evaluation of Q angle and Quadriceps muscle activation on dynamic balance position|Evaluation of Q angle, Quadriceps muscle activation, static and dynamic balance and functionality of all individuals was done.
15745528|NCT04896177|Device|Sirolimus drug-eluting coronary balloon catheter|Patients in experimental group will undergo PCI, using sirolimus drug-eluting coronary balloon catheter.Subjects without stent implantation were regularly treated with dual antiplatelet for 9 months after surgery. Subjects with stents were regularly treated with dual antiplatelet for 12 months after the surgery, in accordance with the applicable guidelines for percutaneous coronary intervention.
15745529|NCT04896177|Device|Paclitaxel drug-eluting coronary balloon catheter|Patients in control group will undergo PCI, using paclitaxel drug-eluting coronary balloon catheter.Subjects without stent implantation were regularly treated with dual antiplatelet for 9 months after surgery. Subjects with stents were regularly treated with dual antiplatelet for 12 months after the surgery, in accordance with the applicable guidelines for percutaneous coronary intervention.
15745530|NCT04896164|Drug|Curcumin Lozenges|Curcumin lozenges (each containing 100 mg of curcumin) will be given at a dose of 4 lozenges (total dose 400 mg curcumin) BD. Formulation is Solid Lipid Curcumin Particle (SLCP). Oral curcumin lozenges will be given from two days prior to receiving high dose chemotherapy till day+28 of transplant.
15745531|NCT04896164|Other|Placebo Lozenges|Placebo lozenges will be given from two days prior to receiving high dose chemotherapy till day+28 of transplant.
15745532|NCT04896151|Diagnostic Test|Minnesota Multiphasic Personality Inventory -2- Restructured Form - Experimental|The MMPI-2-RF-EX is a broadband, self-report measure of personality and psychopathology was developed for research purposes in order to develop the MMPI-3 (Ben-Porath & Tellegen, 2020), which is comprised of a subset of MMPI-2-RF-EX items.
15745533|NCT04896138|Other|Interstitial Lung Disease|Not applicable - this is not an interventional trial
15745534|NCT04896125|Drug|Lumigan PF; Xalatan|Lumigan PF: 0.03% bimatoprost (preservative-free) Xalatan: 0.005% latanoprost (containing 0.02% BAK as a preservative) All patients were instructed to use only the given study medication during the study period.
15745535|NCT04896112|Drug|LNK01002|LNK01002 will be administrated orally.
15745536|NCT04896086|Biological|VRC-FLUMOS0111-00-VP (FluMos-v1)|The VRC-FLUMOS0111-00-VP (FluMos-v1) vaccine is composed of engineered pentamer yeast C. albicans lumazine synthase assembled with 20 HA ectodomain trimers from the following influenza strains: Influenza A (H1: A/Idaho/07/2018, H3: A/Perth/1008/2019) and Influenza B (B/Victoria lineage: B/Colorado/06/2017, B/Yamagata lineage: B/Phuket/3073/2013)
15745537|NCT04896086|Biological|Flucelvax|Flucelvax is a cell-based vaccine which contains the same four influenza strains selected by the WHO, and has shown better safety and immunogenicity profiles that the traditional licensed seasonal egg based vaccine
15745539|NCT04896047|Procedure|Meal test and muscle biopsies|"The FGF19 parameters will be assessed in fasting and in postprandial period after the consumption of a hyper-carbohydrate and hyper-lipidic test meal called Flexmeal.
~A muscle biopsies by a needle will be performed before and after the Flexmeal."
15745540|NCT04896034|Device|MILTA Device|Patients in MILTA Device group will each receive 2 sessions of PBM in this study, the first session within 24 hours of delivery, and the second session 24 hours after the first session.
15745541|NCT04896034|Device|" control 1  fake MILTA device"|Patients in group control 1 will each receive 2 sessions of PBM in this study, the first session within 24 hours of delivery, and the second session 24 hours after the first session.
15745542|NCT04896021|Diagnostic Test|Cardiovascular disease risk assessment|Intervention in which the addition of guideline-recommended absolute cardiovascular disease risk assessment is embedded into point-of-care blood collection services for cholesterol measurement and results (including risk score) are reported to referring doctors.
15745543|NCT04896021|Diagnostic Test|Usual care assessment|Usual care in which blood cholesterol results are reported to referring doctors
15745544|NCT04896008|Drug|Sotatercept|Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1.
15745545|NCT04896008|Other|Placebo|Placebo
15745546|NCT04895995|Behavioral|Daylight dCBT Application|Participants will complete up to four modules of digital intervention delivered in a self-paced format.
15745548|NCT04895956|Procedure|Intra-sheath injection|Ultrasound guided corticosteroid injection composed of 1ml of 1% lidocaine and 1ml (20mg) of dexamethasone. Injection will be administered directly into the abductor pollicis longus/ extensor pollicis brevis sheath.
15745549|NCT04895956|Procedure|Extra-sheath injection|Ultrasound guided corticosteroid injection composed of 1ml of 1% lidocaine and 1ml (20mg) of dexamethasone. Injection will be administered surrounding the abductor pollicis longus/ extensor pollicis brevis sheath.
15745550|NCT04895956|Device|Ultrasound|To ensure accuracy of fluid deposition into the tendon sheath in the intra-sheath injection arm and outside of the tendon sheath in the extra-sheath injection arm, all injections will be performed under ultrasound guidance. The ultrasound machine used will be a portable ultrasound machine located at the UC Davis orthopaedic clinic in Sacramento
15745551|NCT04895943|Procedure|bariatric endoscopy, mainly intragastric balloons, plication of the stomach too|bariatric endoscopy, mainly intragastric balloons, plication of the stomach too
15745552|NCT04895943|Procedure|bariatric endoscopy, mainly intragastric balloons, plication of the stomach too|bariatric endoscopy, mainly intragastric balloons, plication of the stomach too
15745555|NCT04895917|Drug|daratumumab and pomalidomide|Patient eligible to enter the study will receive 6 cycles of 28 days of subcutaneous Daratumumab (1800 mg SC) and oral pomalidomide 4 mg from day 1 to day 21. During cycle 1 and 2, Daratumumab will be administered weekly at days 1, 8, 15, and 22 then from cycle 3 to 6, Daratumumab will be administered every other week at days 1 and 15.
15745556|NCT04895904|Other|No intervention|Our study is an observational study and the main purpose of our study is to observe the efficacy of endoscopic hemostasis and drug therapy
15745557|NCT04895891|Device|EOS hand imaging|For each patient, EOS images are compared with CT images
15745558|NCT04895865|Behavioral|RPE-based load and repetition number selection|Providing trainees with choices regarding the load and the number of repetitions to be performed per set and exercise
15745559|NCT04895865|Behavioral|Predetermined load and number of repetitions|Trainees predetermine the load and perform ten repetitions per set and exercise
15745560|NCT04895852|Device|TEAS|"Acupoint selection (positioning strictly in accordance with the National Standard of the People's Republic of China GB 12346-90 Acupoint Locations): Baihui, Yintang, Hegu, and Taichong, both sides are taken, TEAS is performed every day for three days before surgery, and Han's acupoint nerves are used Stimulator (HANS200A produced by Beijing Huawei Co., Ltd.), sparse and dense wave type, frequency 2/100 Hz (Hz). The center of the electrode is aligned with the acupuncture point, the corresponding lead is connected to the stimulator, the current intensity is 10mA, and all acupoints are stimulated for 30 minutes every day for three days before the operation."
15745600|NCT04895579|Drug|Durvalumab|Durvalumab will be delivered at 10mg/kg via IV infusion at days 1 and 15 every 28 days.
15745601|NCT04895579|Drug|Copanlisib|Copanlisib will be delivered at various doses (30-60mg/kg) via IV infusion at days 1 and 15 every 28 days.
15745602|NCT04895566|Biological|Monoclonal antibody (Mab) sB24M|200 mg monoclonal antibody (Mab) sB24 by injection into the affected areas.
15745645|NCT04895280|Drug|Ketorolac|Ketorolac: will receive an injection of 4 cc 0.25% Marcaine without epinephrine and 30 mg ketorolac x 1
15745561|NCT04895852|Other|Routine perioperative management|Comprehensive evaluation of cardiopulmonary function, preparation of respiratory tract, active treatment of coexisting diseases before operation, correction of water and electrolyte disorders and hypoproteinemia before operation. To prevent cross-infection during the operation, the intraoperative blood volume should be supplemented within the tolerance of cardiac function, the tissue perfusion should be sufficient, and the infusion should be uniform. Strengthen respiratory care after operation, prevent cardiovascular complications, pay attention to the speed and amount of blood transfusion, encourage early activities, promote lung expansion and prevent thrombophlebitis.
15745562|NCT04895839|Behavioral|Patient Empowerment Program|"The 6 months at home program focuses on aerobic and strength training, pelvic floor muscle exercises, meditation, social connection, and overall healthy lifestyle practices supported with daily text message/email reminders. The aerobic (5 times/week) and strength (2 times/week) program will comprise of a single 30-minute session daily and will be individualized to each participant. Pelvic floor muscle training will include three, 10-minute sessions and mediation for 10 minutes daily. Intimacy and Connection component of PC-PEP consists of engaging in at least one form of intimacy practice prescribed, per day. Social connection will be fostered by pairing participants up with peers from the study. To encourage program compliance, study participants will receive 3 daily reminders to do their pelvic floor muscle exercises per day plus an additional motivational email daily containing helpful tips."
15745563|NCT04895813|Behavioral|Education|The patient will be given pre-colonoscopy training and guidance by telephone.
15745564|NCT04895800|Dietary Supplement|Phytovive|Bacopa monnieri bacosides, Kaempferia parviflora methoxy flavones, pomegranate peel polyphenols, and Moringa oleifera leaf saponins)
15745565|NCT04895800|Dietary Supplement|Placebo|Natural Flavors [Chocolate, Caramel, Vanilla Cream], Silica, Inulin, Sucralose)
15745566|NCT04895800|Dietary Supplement|Caffeine|Caffeine (Green tea caffeine extract (170 mg; to deliver 34 mg caffeine [20% natural caf-feine])
15745567|NCT04895787|Behavioral|Gait + aerobic exercise|Following skill-based gait training, the participants in the AEX group will engage in 20 minutes of moderate to high intensity aerobic exercise on a recumbent bicycle. The participants will first perform a brief warm-up, followed by 20 minutes of moderate to high intensity aerobic exercise pedaling at 60-80 rpm with a target heart rate range between 60-70% of heart rate reserve (HRR). Given the potential of having autonomic dysfunction in this population, it has been suggested that a RPE scale between 14-17 is appropriate.
15745568|NCT04895787|Behavioral|Gait + resistance exercises|Following skill-based gait training, the participants in the REX group will engage in resistance training, which will target major muscle groups important for daily activities. The resistance training will be provided with free weights or therabands at an intensity of 8-12 repetition maximum (RM). Each muscle group should be trained with 8-12 repetitions ranging from 1 to 3 sets with resting intervals provided between each set. The target RPE scale will be set between 14-17, and the training load will be progressively increased as the participants improved.
15745569|NCT04895787|Behavioral|Gait + conventional physical therapy|Following skill-based gait training, the participants in the CPT group will receive conventional physical therapy, which may include stretching exercise, balance training, or practice over-ground walking based on the participant's need.
15745570|NCT04895787|Behavioral|Gait + rest|Following skill-based gait training, the participants will sit and rest on a chair.
15745571|NCT04895774|Other|Probiotic strains|Fresh stools will be cultured in vitro in fermenters with adjunction of probiotic strains
15745572|NCT04895774|Other|Polyphenols|Fresh stools will be cultured in vitro in fermenters with adjunction of polyphenols
15745573|NCT04895774|Other|Fibers|Fresh stools will be cultured in vitro in fermenters with adjunction of fibers
15745586|NCT04895709|Drug|BMS-986340|Specified dose on specified days
15745587|NCT04895709|Drug|BMS-936558-01|Specified dose on specified days
15745588|NCT04895696|Drug|BMS-986256 (Oral)|Specified dose on specified days
15745589|NCT04895696|Other|Placebo|Specified dose on specified days
15745590|NCT04895683|Behavioral|Text message content|Behavioural science-informed text messages aimed at improving COVID-19 vaccination uptake.
15745591|NCT04895670|Behavioral|Empowering Youth Aging out of Foster Care|App that allows storage of health information, and access to reputable health information and community resources.
15745592|NCT04895657|Drug|Piperacillin/Tazobactam Continuous infusion|Continuous infusion
15745593|NCT04895657|Drug|Piperacillin/Tazobactam Intermittent infusion|Intermittent infusion
15745594|NCT04895644|Other|No Hard Collar|The patient in the intervention arm will not wear a Hard Collar for 12 weeks post injury
15745595|NCT04895631|Drug|18F-Fluorocholine|Given intravenously
15745596|NCT04895631|Procedure|Positron emission tomography (PET)|Imaging technique that uses radioactive substances known as radiotracers to visualize and measure changes in metabolic processes, and in other physiological activities
15745597|NCT04895592|Drug|Dexamethasone|Given PO or IV
15745598|NCT04895592|Procedure|Resection|Undergo surgical resection
15745599|NCT04895592|Radiation|Stereotactic Radiosurgery|Undergo SRS
15745603|NCT04895553|Other|Observation of ICH and VTE|The treating physician will initiate and prescribe the apixaban, the protocol will only observe and record intracranial pressure (ICP) and VTE incidences.
15745604|NCT04895540|Diagnostic Test|ECG|All study subjects will undergo ECG recording.
15745605|NCT04895540|Diagnostic Test|Echocardiography|All study subjects will undergo transthoracic echocardiography
15745606|NCT04895540|Diagnostic Test|Cardiac MRI|All ACM patients and SCD survivors will undergo cardiac MRI testing.
15745607|NCT04895540|Diagnostic Test|Ambulatory ECG recording|All ACM patients and SCD survivors will undergo 24-hour ambulatory ECG recording
15745608|NCT04895540|Diagnostic Test|Cardiac EP study|ACM patients and SCD survivors will undergo diagnostic cardiac Electrophysiology testing.
15745609|NCT04895540|Genetic|All study subjects will undergo sample collection for genetic testing.|Blood samples and buccal swab will be collected from study subjects for genetic testing.
15745610|NCT04895514|Procedure|Gamma-irradiated corneal tissue inlay|A mid-stomal pocket will be made into the cornea with a femtosecond laser (Intralase). A small disc of gamma-irradiated preserved corneal tissue will then be placed into the pocket
15745611|NCT04895501|Other|running flexible shoes|21kms of running flexible shoes followed by a time-to-exhaustion run.
15745614|NCT04895475|Behavioral|SARS-CoV-2 vaccine|Baseline demographics, baseline breast milk samples, and blood collection will be obtained at the initial visit. Serial collections of breastmilk and blood as well as weekly self-administered monthly surveys will occur
15745615|NCT04895449|Biological|MVA-SARS-2-ST|i.m. vaccine administration
15745616|NCT04895449|Biological|Licensed COVID-19 vaccine|i.m. vaccine administration
15745617|NCT04895436|Drug|Venetoclax|Oral tablet
15745618|NCT04895436|Drug|Obinutuzumab|Intravenous (IV) infusion
15745619|NCT04895423|Drug|Methotrexate therapy|Methotrexate subcutaneously 10-15 mg/m2 once every 7 days within 12 months
15745620|NCT04895423|Drug|Mycophenolate mofetil therapy|Mycophenolate mofetil per os 500-700 mg/m2 2 times a day within 12 months
15745621|NCT04895423|Drug|Cyclosporine therapy|Cyclosporine per os 3 mg/m2 2 times a day within 12 months
15745622|NCT04895423|Drug|Dupilumab therapy|Patients weighing <30 kg received an initial dose of 600 mg (2 injections of 300 mg subcutaneously), then 300 mg every 4 weeks. Patients weighing 30 to <60 kg received an initial dose of 400 mg (2 injections of 200 mg subcutaneously), then 200 mg every 2 weeks; Patients weighing 60 kg or more, the initial dose is 600 mg (2 injections of 300 mg subcutaneously), then 300 mg every 2 weeks.
15745623|NCT04895410|Biological|Lemzoparlimab|Intravenous (IV) infusion
15745624|NCT04895410|Drug|Dexamethasone|Oral tablet or IV infusion/injection
15745625|NCT04895410|Drug|Carfilzomib|IV infusion
15745626|NCT04895410|Drug|Pomalidomide|Oral capsule
15745627|NCT04895410|Biological|Daratumumab|Subcutaneous (SC) injection
15745628|NCT04895397|Device|ultrasound guided Nerve Block procedure|"In group A patients, an ultrasound guided modified pectoral nerve block will be performed Under sterile conditions, US-guided PECSII block will be on the same side of surgery . The 6-13 MHz linear probe will be put transversely in the ipsilateral clavipectoral triangle - between the clavicle medially and above and the shoulder joint laterally.
~the needle will be advanced in an in-plane technique targeting the space in which the artery is located. Afterward, 10 mL of bupivacaine, 0.25%, will be injected.
~the needle will be advanced in-plane targeting the plane between the pectoralis minor muscle and serratus. Two mL of saline 0.9% will be injected; then, 10 mL of bupivacaine 0.25% will be injected.
~Group B: In SAPB Group, a US-guided serratus block will be done The ribs will be then counted, and when the 4th rib will be identified, the high-frequency probe will be put over it, in the mid-axillary line in a sagittal plane."
15745629|NCT04895384|Device|Edwards ClearSight and Masimo SET|Placement of Edwards ClearSight and Masimo SET on the patient intraoperatively.
15745630|NCT04895371|Other|Tele-physiotherapy group|Allocated participants to this group will receive 18 physiotherapy sessions (three sessions per week) during six weeks. in these sessions, physiotherapist will prescribe aerobic, resistive, breathing and functional exercises and airway clearance techniques (if needed) based on result of assessment of patients at the discharge phase. the physiotherapist will use some educational contents for the patient and call him/her to guide the patient about how exercises should be performed (determining frequency, time, intensity and type of exercise). the patient should do exercises until next session and provide a feedback. The patient will be assessed weekly using a pre-designed questionnaire remotely. the progression of interventions will be based on the results of weekly assessment.
15745631|NCT04895371|Other|Control group|Allocated participants to control group will receive one consultation session by the physiotherapist. At this session, patients will be educated about how to perform their daily activities, breathing exercises, walking, using oxygen cylinder and dietary.
15745639|NCT04895345|Drug|TQB2450|TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
15745640|NCT04895345|Radiation|Intensity modulated radiotherapy|Intensity-modulated conformal radiotherapy (IMRT) is a kind of three dimensional conformal radiotherapy, which requires the dose intensity in the radiation field to be adjusted according to certain requirements.
15745641|NCT04895319|Device|Computer-assisted surgery|The reconstruction was performed with the help of virtual surgical plan and 3D printed models.
15775653|NCT04649216|Drug|[14C]PCO371|[14C]PCO371 Solution for infusion
15745646|NCT04895280|Drug|Marcaine|Marcaine (control): will receive an injection of 4 cc 0.25% Marcaine without epinephrine
15745647|NCT04895280|Drug|Kenalog|Kenalog: 4 cc 0.25% Marcaine without epinephrine and 40 mg triamcinolone x 1.
15745648|NCT04895267|Device|Low-field thoracic magnetic stimulation (LF-ThMS)|A 30 minutes session of low-field thoracic magnetic stimulation (LF-ThMS) is planned for each participant.
15745649|NCT04895254|Device|Diagnostic colonoscopy|The feasibility of the motorized spiral enteroscope to achieve cecum intubation in difficult colons.
15745650|NCT04895254|Procedure|Therapeutic colonoscopy|The feasibility of the motorized spiral enteroscope for performing interventions such as polypectomy
15745653|NCT04895228|Procedure|injection|triamcinilone 40 mg injection (Kenacort) + 4 ml of .5 % lidocaine hydrochloride (Xylocaine) under ultrasound guidance
15745657|NCT04895189|Other|No intervention|There is no intervention for this observational study. The investigators are observing the changes in participants before and after the participants receive the COVID-19 vaccine, which participants will receive outside of the study.
15745658|NCT04895163|Procedure|Laparoscopic appendectomy|Laparoscopic appendectomy performed for acute appendicitis
15745659|NCT04895137|Drug|mFOLFOX6+Bevacizumab+PD-1 monoclonal antibody treatment combinations|mFOLFOX6+ Bevacizumab+PD-1 monoclonal antibody treatment combinations in patients with local advanced microsatellite stability colorectal cancer
15745660|NCT04895111|Diagnostic Test|Endobronchial ultrasound strain elastography|Measurement of tissue elasticity of hilar and mediastinal lymph nodes through strain elastography measured during an endonbronchial ultrasound examination
15745661|NCT04895098|Drug|statin and ezetimibe combination therapy|Receiving statins in combination with ezetimibe in a stable dosing regimen (without changing the dose of the therapy and/or replacing the statin) for 3 or more months at the time of enrolment in the study.
15745662|NCT04895098|Drug|statin monotherapy|Receiving statins as monotherapy in a stable dosing regimen (without changing the dose of the therapy and/or replacing the statin) for 3 or more months at the time of enrolment in the study.
15745663|NCT04895085|Diagnostic Test|BinaxNOW Rapid Antigen System|"BinaxNOW Rapid Antigen System (Abbott) is a point-of-care, lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct anterior nasal (nares) swabs. Internal controls are built into the testing system and results are available in 15 minutes.
~The use of the BinaxNOW system is authorized under the Food and Drug Administration's Emergency Use Authorization. The test is allowed for over-the-counter, non-prescription use with or without symptoms. The test may be used with children two years and older with the help of sample collection by an adult, and the test may be self-administered by anyone aged 15 years or more."
15745666|NCT04895059|Drug|Rosuvastatin (20mg) /Ezetimibe (10mg) in fixed dose|Form: Tablets Dosage: 20 mg Adminstration way: Oral
15745667|NCT04895059|Drug|Rosuvastatin 20mg|Pharmaceutical Form: Tablets Dosage: 20 mg Adminstration way: Oral
15745668|NCT04895059|Drug|Ezetimibe 10mg|Pharmaceutical Form: Tablets Dosage: 10 mg Adminstration way: Oral
15745672|NCT04895033|Behavioral|Responsibility condition|During the fMRI scan, participants will complete alcohol purchase task paradigm for hypothetical alcohol rewards under two conditions. In the next-day responsibility condition, we will present a vignette describing a drinking scenario in which participants have a significant activity the next day (e.g., a work, family, or academic obligation the next morning) and participants are asked to imagine they are deciding how much they want to drink in this situation. The control condition will use a vignette describing a typical drinking scenario with no explicit responsibilities the next day
15745673|NCT04895020|Biological|9-valent HPV vaccine|9-valent HPV recombinant vaccine (Hansenula Polymorpha) All subjects aged 9 to 45 years received 3 doses of 9v HPV vaccine at 0,2,6 month scehdule
15745674|NCT04895007|Biological|Covid-19 Inactive Vaccine, recombinant human adenovirus serotype number 26, mRNA VAccine|Anti-SARS-CoV-2 IgG Antibody and Neutralizing Antibody will be evaluated 2, 6, 12 Months after second dose.
15745675|NCT04894994|Drug|FLX475|Tablet
15745676|NCT04894994|Drug|Ipilimumab|IV infusion
15745677|NCT04894981|Device|Immersive condition (CAVE)|Driving course with obstacles in a CAVE system
15745678|NCT04894981|Device|Immersive condition (HMD)|Driving course with obstacles with a virtual reality headset
15745679|NCT04894981|Device|Non Immersive condition (Screen alone)|Driving course with obstacles on a screen with physical simulator
15745680|NCT04894981|Device|Non Immersive condition (Screen with physical simulator)|Driving course with obstacles on a screen only
15745681|NCT04894968|Diagnostic Test|Assessment of the presence of heart failure with preserved ejection fraction, according to guideline recommendations from the European Society of Cardiology 2016|"Patient will be screened for the presence of heart failure with preserved ejection fraction, according to guideline recommendations from the European Society of Cardiology 2016.
~This requires patients to fulfill all of the four criteria listed below:
~Symptoms of heart failure (e.g. dyspnea on extertion)
~Preserved ejection fraction (Left ventricular ejection fraction ≥50%
~NT-proBNP ≥125 pg/mL
~Echocardiographic signs for structural heart disease or diastolic dysfunction (at least one of the criteria below)
~Left atrial volume index >34 mL/m²
~Left ventricular mass index ≥115 g/m² for males or ≥95 g/m² for females
~E/e' ≥13
~Septal e' <9 cm/s"
15745965|NCT04892563|Procedure|Erector Spinae Plane Block|Nerve block with local anesthetic in the erector spinae plane
15745682|NCT04894955|Device|MARIA|After consent has been given, the participant's breast will be fitted by the operator using a clear plastic cup to ascertain their corresponding MARIA® cup insert size. Once this has been determined, participants will be required to lie prone with their breast pendent through an aperture in the MARIA® participant bed. The cup insert will contain a layer of coupling fluid. The hemispherical cup inserts and array are brought into contact with the breast. A scan sequence comprising of two complete scan rotations will then be performed, which takes around 5 minutes. The participant will then be assisted to adjust their positioning, and the scan sequence performed on the other breast.
15745683|NCT04894942|Other|American Orthopaedic Foot and Ankle Society Score (AOFASS)|calculation of the score AOFASS before and after the surgery
15745684|NCT04894929|Other|multi component exercise|"Patients randomly assigned to this group have a pre-fragile or fragile SPPB condition, so they will perform:
~3 days of empowerment work, 4 days of flexibility work, and daily walking aerobic work and balance work."
15745685|NCT04894929|Other|vestibular exercise|"Patients randomly assigned to this group have a pre-fragile or fragile SPPB condition, so they will perform. sessions of about 20 minutes with 5 weekly sessions (Monday to Friday) consisting of 5 repetitions without fatigue of:
~to. Head and eye movements while sitting. b. Head and body movements while sitting. c. Exercises standing. d. Combined exercises of modifications in steps, unstable surfaces and in progress.
~and. Along with push up 30sec and squat 30sec"
15745687|NCT04894903|Other|Diabetes Care Gaps Patient Portal Intervention|The Diabetes Care Gaps Patient Portal Intervention is embedded within an existing patient web portal (My Health at Vanderbilt). The intervention (a) notifies patients when selected, clinically meaningful, evidence-based diabetes monitoring & preventative care (e.g., annual urine microalbumin) are due and (b) allows patients to initiate orders for the care.
15745688|NCT04894890|Drug|secukinumab|There is no treatment allocation. Patients administered secukinumab by prescription that have started before inclusion of the patient into the study will be enrolled.
15745689|NCT04894877|Procedure|cardiac catheterization|Narrowed blood vessels can be opened without surgery using stents or can be bypassed with surgery. To determine which is the best approach for you the doctor needs to look at your blood vessels to see where the narrowings are and how much narrowing there is. This is done by a procedure known as a cardiac catheterization.
15745690|NCT04894877|Procedure|coronary artery bypass graft surgery|"Artery narrowing is bypassed during surgery with a healthy artery or vein from another part of the body. This is known as coronary artery bypass grafting, or CABG (said, cabbage). The surgery creates new routes around narrowed and blocked heart arteries. This allows more blood flow to the heart."
15745691|NCT04894877|Procedure|percutaneous coronary intervention|Percutaneous coronary intervention may be done as part of the cardiac catheterization procedure. With this procedure a small, hollow, mesh tube (stent) is inserted into the narrowed part of the artery. The stent pushes the plaque against the artery wall, and opens the vessel to allow better blood flow.
15745692|NCT04894877|Behavioral|Lifestyle|diet, physical activity, smoking cessation
15745693|NCT04894877|Drug|Medication|antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies
15745694|NCT04894864|Drug|Opioid-Based Anesthesia-Analgesia Strategy|A perioperative Opioid-Based multimodal Anesthesia-Analgesia strategy will be implemented as described in the Opioid-Based arm of the study.
15745695|NCT04894864|Drug|Opioid-free Anesthesia-Analgesia Strategy|A perioperative Opioid-Free multimodal Anesthesia-Analgesia strategy will be implemented as described in the Opioid-Free arm of the study.
15745696|NCT04894851|Behavioral|Contingency Management|Participants in the current study will receive contingencies for improvement in clutter, as measured by a trained, independent in-home rater. Ratings will be completed by after study consent, and once every month thereafter, being conducted at weeks 0, 4, 8, 12, and 16 of treatment. Participants will be reimbursed for each new 1-point reduction in CIR score, a set dollar amount per month for each CIR point reduction they maintain from baseline. Therefore, a perfectly performing patient would earn reimbursement (A CIR reduction of 8 points made in the first month and maintained throughout treatment. If a CIR score is higher than the prior month, the reinforcement schedule will reset to zero.
15745697|NCT04894838|Procedure|Distal gastric bypass|Distal gastric bypass, revisonal surgery after failed RYGB
15745698|NCT04894825|Drug|M108|Monotherapy: Accelerated titration method, IV infusion Q3W; Conventional 3 + 3 study design, IV infusion Q3W. (21-day cycles) Combined with chemotherapy: Conventional 3 + 3 study design, IV infusion Q3W. (21-day cycles)
15745699|NCT04894825|Drug|M108|IV infusion Q3W. (21-day cycles)
15745700|NCT04894812|Other|Neurodevelopmental technique|"st month: postural maintenance; exercises with weight on forearms and hands, in sitting, crawling, semi-kneeling and standing positions with support from therapist.
~nd month: balance and corrective reactions; using CP ball and tilt board.
~rd month: ambulation training; appropriate to motor development level (crawling, creeping, walking in a semi-kneeling position and walking between parallel bars)."
15745701|NCT04894799|Other|Vestibular stimulation|In Vestibular Stimulation (VS) group, all participants will be given Infant Swing activity for one hour, trice a day for first 4 weeks. After that, in 5th and 6th weeks, all participants will be given Infant Swing for 30 minutes and frog swing for 30 minutes for two weeks. Next 7th and 8th weeks, Infant Swing (30 minutes) and prone on frog swing feet touching the floor (30 minutes), trice a day will be applied. In 9th week, Infant swing and normal playground swing for 30,30 minutes will be given to all participants, trice a day. In Last week of intervention i.e., 10th week, all participants will be given Infant Swing for 30 minutes and standing on platform swing (30 minutes) trice a day.
15745841|NCT04893629|Biological|mono nuclear cells injection|trans endocardium injection of autologous mono nuclear cells for the intervention group and classic treatment for the control group
15745842|NCT04893629|Drug|Digoxin+furosemide+captopril|classical heart failure medical treatment
15745966|NCT04892563|Drug|IV Analgesia|IV analgesia, typically Morphine/Opioid medications
15776267|NCT04644068|Drug|Carboplatin|Platinum chemotherapeutic
15745702|NCT04894799|Other|Neck Control facilitation exercises|all participants will be given Neck Control facilitation exercises using Bobath Approach of low tone facilitation method, for one hour, trice a day for first 4 weeks. After that, in 5th and 6th weeks, all participants will be given Neck Control facilitation exercises for 30 minutes and sitting facilitation Exercises with trunk weight shifting for 30 minutes, trice a day. Next 7th and 8th weeks, Neck Control facilitation exercises (30 minutes) and sitting facilitation exercises with trunk weight shifting and kneeling weight bearing (30 minutes), trice a day will be applied. In 9th and 10th weeks, Neck Control facilitation exercises, sitting and kneeling weight bearing and standing with trunk elongation will be given to all participants for one hour, trice a day.
15745703|NCT04894786|Other|Mulligan Internal Rotation Mobilization|Mulligan Internal Rotation Mobilization (MIRM) Sleeper Stretch The therapist places a web of his one hand around patient's axilla and thumb of another hand in the bent elbow and the glide will be applied to the head of the humerus down in the glenoid fossa using thumb while stabilizing the scapula with another hand. Therapist will ensures that the other hand is stabilizing up and inwards. While this distraction is taking place the patient internally rotated his shoulder with the help of another hand, at the same time his affected upper arm will abduct by therapist abdomen distracting the head of the humerus laterally. The hand in axilla acts as a fulcrum. Mulligan MWM will be applied for 3 days alternate days by following the rule of 3
15745704|NCT04894786|Other|Post Isometric Relaxation Technique|Post Isometric Relaxation Technique (PIRT) Sleeper Stretch The subject will be positioned supine on the treatment table with the shoulder and elbow, at 90 degree of abduction and flexion. The shoulder will be stabilized at the acromion process with one hand, and the other hand will be used to passively move the arm into internal rotation until the first barrier of motion will reached. The subject will be then instructed to perform a 5second isometric contraction of approximately 25% maximal effort in the direction of external rotation, against an opposing force provided at the distal forearm. Following the contraction, the subject will be instructed to internally rotate the arm toward the ground as a 30-second active assisted stretch will be applied. The subject will be instructed to relax, and a new movement barrier will then engage.
15745705|NCT04894773|Other|Imaginary Resistance Exercises|In imaginary resistance exercises, resistive force is assumed to get applied by the patient after demonstrating some resistive objects and the kind of force exerted by them.
15745706|NCT04894773|Other|Physical Resisted Exercises|In physical resistance exercises, resistive force is applied to the targeted region by using different and appropriate resistive objects.
15745707|NCT04894760|Diagnostic Test|Rapid Antigen Test (PanBio Ag test)|Rapid Antigen Test (PanBio Ag test)
15745708|NCT04894747|Dietary Supplement|Bolus ingestion of protein|Ingestion of 25g of protein
15745709|NCT04894734|Device|EES on|Epidural electrical stimulation (EES), also known as spinal cord stimulation (SCS), is a common FDA-approved therapy for chronic neuropathic pain of trunk and limb.
15745710|NCT04894734|Device|EES off|Epidural electrical stimulation (EES), also known as spinal cord stimulation (SCS), is a common FDA-approved therapy for chronic neuropathic pain of trunk and limb.
15745711|NCT04894721|Drug|Ivermectin|0,6mg/kg of weight orally on days 1 and 7
15745712|NCT04894721|Other|Placebo|A substance with similar physical characteristics as ivermectin, without the active drug ingredient
15745713|NCT04894708|Procedure|colonoscopy|addition of polyp detection algorithm by Fujifilm
15745714|NCT04894695|Diagnostic Test|biomarkers detection in different groups|Biomarkers of urine exosomes in different groups were identified by sequencing technology，then biomarkers were validated using urine samples of different groups
15745715|NCT04894682|Biological|Vaccine inoculation against SARS-CoV-2|Inoculation with any type of approved vaccines according to the standard or recommended dose
15745716|NCT04894656|Diagnostic Test|Labs, urine tests, upper endoscopy with biopsy and confocal laser endomicroscopy|Tests to assess intestinal permeability
15745717|NCT04894643|Radiation|Proton Ions|According to the radiation plan (between 50.4 and a maximum of 60.2 Gy) after Chemotherapy with Nab-PACLitaxel (Abraxane®) + Gemcitabine and concomitant to Capecitabine.
15745718|NCT04894643|Drug|Nab-PACLitaxel|"Chemotherapy will be delivered upfront for three cycles (week 2-4, week 6-8 and week 10-12) with combined Nab-PACLitaxel (Abraxane®) and Gemcitabine Therapy.
~It will be administered as intra venous infusion over 30 minutes."
15745719|NCT04894643|Drug|Gemcitabine|"Chemotherapy will be delivered upfront for three cycles (week 2-4, week 6-8 and week 10-12) with combined Nab-PACLitaxel (Abraxane®) and Gemcitabine Therapy.
~Gemcitabine will also be administered as intra venous infusion over 30 minutes immediately after Nab-PACLitaxel."
15745720|NCT04894643|Drug|Capecitabine|Concomitant to proton-radiotherapy (on the same days, within week 14-19)
15745721|NCT04894643|Procedure|Surgical resection of the pancreas (when feasible)|Pre surgical re-evaluation will be performed at week 21 after enrollment. Patients fulfilling surgery-entry criteria, which consist of no distant metastasis, no massive ascites, no massive pleural effusion, no serious infection, no serious, unresolved chemoradiotherapy related, adverse events and adequate organ system function, will undergo surgery on week 22 (± 1 week). This should be performed via laparotomy.
15745722|NCT04894630|Other|antimicrobial treatment|Detailed history taking and all clinical findings were collected. Corneal scrapings were obtained from patients and subjected to staining and culture for bacterial and fungal pathogens; Bacterial and fungal growth were identified by standard laboratory procedures.
15745723|NCT04894617|Drug|Amantadine|200 mg Amantadine daily for a total of 5 days.
15745724|NCT04894617|Drug|Lactose monohydrate|Lactose monohydrate two tablet daily for a total of 5 days.
15745725|NCT04894604|Device|Avance® Solo NPWT System|Application of the Avance® Solo NPWT System on up to 34 study Subjects, in accordance with the IfU for up to 14 days.
15745726|NCT04894591|Drug|Zepzelca|Zepzelca is administered by intravenous infusion over 60 minutes every 21 days. Date, dose prescribed and received will be collected at each Zepzelca infusion.
15745727|NCT04894578|Procedure|reverse distal metatarsal minimal-invasive osteotomy|minimal-invasive oblique osteotomy of the two or three metatarsal bones using a straight burr
15745728|NCT04894578|Procedure|tarsometatarsal fusion|open procedure with fusion and screw and plate fixation of two to three tarsometatarsal joints
15745729|NCT04894565|Procedure|rehabilitation|physical therapy 24 hrs after surgery
15745895|NCT04893148|Drug|Dulaglutide|Add dulaglutide to insulin glargine
15778211|NCT04628429|Drug|Fremanezumab|anti-CGRP-ligand monoclonal anti-body
15745730|NCT04894552|Procedure|Laparoscopic Hysterectomy and Sentinel Lymph Node Biopsy for Endometrial Carcinoma|Patients with endometrial carcinoma will undergo laparoscopic hysterectomy and sentinel lymph node biopsy. The patient will be positioned in a modified lithotomy position with the hips flexed 30 degrees. Blue dye is injected at the cervix. The round ligament will be transected. Sentinel lymph nodes will be detected, dissected and isolated. Then standard lymphadenectomy will be done. Then the infundibulopelvic ligament will be transected. Ligation of the uterine vessels. The cardinal ligaments will be transected, and the vaginal fornices will be opened laparoscopically. The whole specimen will be removed through the vagina. The vaginal cuff will be then closed trans-vaginally. Intraoperative and early postoperative complications will be assessed. The isolated sentinel lymph node will be sent for pathological study as well as the standard lymphadenectomy specimens. Both specimens will be compared to assess the diagnostic reliability and sensitivity of the sentinel lymph node.
15745731|NCT04894539|Device|DS5 electrical stimulator|TENS
15745732|NCT04894526|Other|Alternating Energy Intake|To alternate between caloric overconsumption (130% of usual total energy needs) and caloric underconsumption (70% of usual total energy needs) on a daily basis for 6 days/week followed by one ad libitum day for 4 weeks.
15745733|NCT04894526|Other|Regular Energy Intake|To consume the usual energy intake (100% of total energy needs) on a daily basis for 6 days/week, also followed by one ad libitum day for 4 weeks.
15745734|NCT04894513|Other|Kabat motor control re-education therapy|Kabat motor control re-education therapy that includes specific movements with predefined patterns of facial muscles exercises, which is spiral and diagonal movements involve the facial muscles, which are brought to train in global patterns. The program of treatment for three times per week for six weeks.
15745735|NCT04894513|Other|conventional selected program|the conventional selected program in the form of electrical stimulation (Faradic current) of affected muscles, facial muscle exercise program in front of the mirror, and home advices.
15745736|NCT04894500|Diagnostic Test|Flow fluorescence cytometry|Level of inflammatory markers in body fluid samples
15745737|NCT04894487|Behavioral|THE USE OF BABY MOBILE ACCOMPANIED WITH BRAHMS LULLABY|Using of baby mobile and listening Brahms Lullaby during sternum dressing process
15745738|NCT04894474|Drug|BI 767551 intravenous|BI 767551 intravenous
15745739|NCT04894474|Drug|BI 767551 inhalation|BI 767551 inhalation
15745740|NCT04894474|Drug|Placebo intravenous|Placebo intravenous
15745741|NCT04894474|Drug|Placebo inhalation|Placebo inhalation
15745742|NCT04894461|Device|Moxibustion|The moxibustion treatment sessions are three times per week for eight weeks. Indirect moxa stick will be used.
15745743|NCT04894448|Biological|COVID-19 Vaccine|Any COVID-19 vaccine (1 or more doses)
15745744|NCT04894435|Biological|mRNA-1273 SARS-CoV-2 vaccine|Contains 1.26 mg of CX-024414 mRNA and 24.38 mg of SM-102 LNP as a white to off-white dispersion in preservative-free diluent buffer at pH 7.5.
15745745|NCT04894435|Biological|BNT162b2|A white to off-white, sterile, preservative-free, frozen suspension for intramuscular injection, supplied with 0.9% sodium chloride diluent for injection plastic ampoules.
15745746|NCT04894435|Biological|ChAdOx1-S [recombinant]|A colourless to slightly brown, clear to slightly opaque solution containing 5 x 1010 viral particles (not less than 2.5 x 108 infectious units).
15745747|NCT04894435|Other|0, 28 day schedule|Second injection administered 28 days post first injection
15745748|NCT04894435|Other|0, 112 day schedule|Second injection administered 112 days post first injection
15745749|NCT04894422|Other|Observational intervention|Voluntarily (not) wearing a face mask (cotton or surgical) for 4 hours, following the government's guidelines during the COVID-19 pandemic.
15745750|NCT04894409|Device|Mouthwash and nose rinse with the AgNPs solution|"The experimental group was instructed to do mouthwash and nose rinse with the AgNPs solution for the prevention of SARS-CoV-2 infection in health workers"
15745751|NCT04894409|Device|Mouthwashes and nose rinse in a conventional way|The control group was instructed to do mouthwashes and nose rinse in a conventional way
15745752|NCT04894396|Device|Aetrex L2305 Premium Memory Foam Orthotics W/ Metatarsal Support|An Orthotic insole to be inserted into shoes. Features Aetrex Arch Support to help biomechanically align the body & help prevent common foot pain such as Plantar Fasciitis, Arch Pain and Metatarsalgia. For medium to high arches with forefoot pain, featuring a cupped heel to cushion and stabilize the back of foot and a metatarsal pad to redistribute weight to relieve ball-of-foot discomfort. With 43% more memory foam in the forefoot for those experiencing foot discomfort or fatigue.
15745753|NCT04894396|Device|Aetrex L2300 Premium Memory Foam Orthotics|An Orthotic insole to be inserted into shoes. Features Aetrex Arch Support to help biomechanically align the body & help prevent common foot pain such as Plantar Fasciitis, Arch Pain and Metatarsalgia. With 43% more memory foam in the forefoot for those experiencing foot discomfort or fatigue.
15745754|NCT04894383|Device|Aetrex L420 Compete Orthotic|An orthotic insole to be inserted into shoes. Orthotic for low arches to flat feet with no forefoot pain, featuring a posted heel to control over-pronation and provide balance. Features Aetrex Arch Support to help biomechanically align the body & help prevent common foot pain such as Plantar Fasciitis, Arch Pain and Metatarsalgia.
15745755|NCT04894383|Device|Aetrex indoor comfort sandal with built-in arch support|An indoor comfort sandal with built-in arch support to be used at home. Provides extreme cushioning, shock absorption and durability. Arch support helps to stabilize and align feet and also helps to relieve common foot pain & plantar fasciitis.
15745756|NCT04894370|Biological|Sample collection|"PBMC collection at baseline, after radiotherapy 8 Gy (gray), at 6 months and at 12 months from inclusion: 6 EDTA tubes of 6 ml of peripheral blood mononuclear cell [PBMC] will be sent to the central laboratory (Biomonitoring Platform of Besançon, CHRU de Besançon located at Etablissement Français du Sang) at room temperature within 24 hours via an approved carrier for their processing, storage and immunomonitoring analysis. A sending sheet of the samples will be attached to each single sample.
~Plasma collection at baseline, after radiotherapy 8 Gy, at 6 months and at 12 months from inclusion: One 6 ml EDTA tube should be frozen in each investigation center for plasma collection.
~Plasma for circulating tumoral DNA (ctDNA) collection at baseline, at 2, 6 and 12 months from inclusion: two EDTA tube of 4 ml should be frozen in each investigation center for ctDNA collection."
15745896|NCT04893135|Other|pratice physical activity|treadmill walking : walk at a speed of 2.7 km.h-1 in 3 stages of 3 mins with an incline of 0%, 5% and 10%
15746539|NCT04887922|Device|Conventional spirometer|Will be provided to participants
15745757|NCT04894357|Other|Phenotypic resistance measure|SDM experiments: Reverse transcriptase mutants of HIV-1 will be obtained by site-directed mutagenesis using specific primers introducing the expected mutations into plasmids pNL4.3 and CRF02_AG. HIV-1 stocks will be obtained by transfecting 293-T cells with the various HIV-1 molecular clones. 48 hours after transfection, the viral supernatants will be recovered, quantified for HIV-1p24gag antigen (Vidas BioMérieux) and frozen at -80°C.The single-cycle virus titers will be determined on HeLa-P4 cells in which the expression of b-galactosidase is inducible by the HIV Tat protein. Phenotypic analysis: creation of replication competent chimeric viruses through homologous recombination between patient or laboratory virus-derived PCR fragments and the corresponding NL4-3 vector where the whole Gag-PR, RT-RNaseH or IN coding regions have been deleted through inverse PCR. The susceptibility to Doravirine will be calculated through a single round infection assay in TZM-bl cells.
15745758|NCT04894344|Behavioral|Education group|Is taught to choose low-sodium foods
15745759|NCT04894331|Other|Dietary intervention|"Each patient receives one of 5 dietary plans, different only for energy intake (1400-1600-1800-2000-2100 Kcal/day). The choice depends on the personalized energy needs. The energy requirement is calculated on basal metabolic rate (BMR) of the patient according to Harris & Benedict's and Schofield's formulas.
~All dietary plans include foods with low-Ni content. Finally, each patient completes 30-day personalized diet."
15745760|NCT04894331|Other|Video call|Each patient receives a follow-up remote visit through video call 15 and 30 days after the start of the dietary intervention.
15745761|NCT04894318|Behavioral|Low-fat and low-cholesterol diet|Low-fat (<30% of total energy) and low-cholesterol (<200mg/day) diet total of 12 weeks
15745763|NCT04894292|Other|Non intervention|During the study there is no extra intervention planned for the participants.
15745764|NCT04894266|Drug|Apabetalone|Apabetalone 100mg BID
15745765|NCT04894266|Other|Standard of care|Standard of Care
15745766|NCT04894253|Biological|SRAS-CoV-2 vaccination immunological response|"Follow for 18 months a single group of 30 patients with systemic lupus after their SRAS-CoV-2 vaccination.
~Intervention includes immunological analysis on additional volume of blood collected as part of routine care."
15745767|NCT04894240|Drug|Monepantel|Monepantel is provided to individuals living with ALS/MND as a white oval tablet to be administered once a day following meals
15745768|NCT04894227|Biological|Inactivated SARS-CoV-2 Vaccine (Vero cell）|600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection
15745769|NCT04894214|Diagnostic Test|Arterial blood gas (ABG)|Arterial blood gasses will be drawn during baseline PCV, and every 15 minutes during FCV and VCV respectively. pO2 (mmHg), pCO2 (mmHg) and pH will be recorded.
15745770|NCT04894214|Other|Recording of hemodynamic monitoring|Hemodynamic parameters (invasive arterial blood pressure (mmHg) and heart rate (beats per minute)) will be recorded every 5 minutes.
15745771|NCT04894214|Other|Recording of respiratory monitoring|Tidal volume (ml), respiratory rate (breaths per minute), minute volume (l/min), dynamic compliance (ml/cmH2O), resistance (cmH2O/l/min), plateau pressure (cmH2O), mean airway pressure (cmH2O), positive end-expiratory pressure (cmH2O), peak inspiratory pressure (cmH2O) and fraction of inspired oxygen will be recorded every 5 minutes.
15745772|NCT04894201|Radiation|Dental Panoramic Radiographs|Exposure to dental panoramic radiographs
15745773|NCT04894188|Radiation|radiation therapy|Intensity modulated radiation therapy (IMRT), with 50 Gy in 25 daily fractions (2 Gy/fraction, 5 fractions weekly) for 5 weeks (week 1 - week 5).
15745774|NCT04894188|Drug|Goserelin 3.6 MG|Gosereline 3.6mg sc injection at week 1, week 5, and week 9
15745775|NCT04894188|Procedure|radical prostatectomy|Eligible patients will undergo robotic-assisted radical prostatectomy and pelvic lymph node dissection
15745776|NCT04894162|Other|Questionnaire|Consecutive, eligible inpatients in a participating specialist palliative care unit will be invited to participate in the research: those who wish to participate will complete a research questionnaire about research preferences.
15745777|NCT04894149|Other|Physiotherapy|Supervised physiotherapy one hour twice weekly and 20 minutes three times weekly during 14- 17 weeks before surgery during neoadjuvant chemotherapy or chemoradiotherapy and during eight weeks after surgery (sometimes during adjuvant chemotherapy)
15745778|NCT04894136|Procedure|ICSI-TESE; embryo-transfer|The sperm injected into the cytoplasm of an oocyte (Intracytoplasmatic Sperm Injection) is obtained by testicular extraction. Ultrasound guided transvaginal embryo transfer.
15745781|NCT04894110|Drug|EO2002|EO2002 (magnetic human corneal endothelial cells [HCECs]) with and without endothelial brushing (EB) or Descemet Stripping (DS)
15745782|NCT04894097|Device|radial extracorpeal shock wave|Swiss DolorClast® Master - Shockwave Therapy System will be used to apply the radial extracorporeal shock wave. It consists of master console, Evo Blue hand-piece, 15mm and 36mm interchangeable contact heads (applicators), contact gel, cart, and external compressor
15745783|NCT04894084|Device|CP321|The primary objective is to evaluate the system performance of the test product. This is done by asking subjects to answer questions throughout the study
15745784|NCT04894071|Drug|QA102|"Intervention of Part 1: 6 dose levels (50mg, 100mg, 200mg, 400mg, 800mg, 1600mg of QA102 capsules), oral administration, single dose.
~Intervention of Part 2: 2 dose levels (the dose levels, dosing frequency and dosing duration will be decided on the basis of data from Part 1 of the study), oral administration.
~Intervention of Part 3: 1 dose level (the dose levels, dosing frequency and dosing duration will be decided on the basis of data from Part 2 of the study), oral administration."
15745785|NCT04894071|Drug|Placebo|"Intervention of Part 1: 6 dose levels (50mg, 100mg, 200mg, 400mg, 800mg, 1600mg of Placebo capsules), oral administration, single dose.
~Intervention of Part 2: 3 dose levels (the dose levels, dosing frequency and dosing duration will be decided on the basis of data from Part 1 of the study), oral administration.
~Intervention of Part 3: 1 dose level (the dose levels, dosing frequency and dosing duration will be decided on the basis of data from Part 2 of the study), oral administration."
15745897|NCT04893122|Other|COVID-19 pandemic|Study focuses on the impact of the COVID-19 pandemic on emergency attendances and admissions.
15745786|NCT04894058|Procedure|Ureteroscopic lithotripsy|"After combined spinal and epidural anesthesia, patients were subjected to low pressure perfusion; The semirigid ureteroscope was passed through the urethra to the bladder, after which both ureteral orifices were observed. A 0.035 soft-tipped guidewire was sent through the ureter orifice and reached the renal pelvis. Subsequently, the patients were placed in the reverse trendelenburg position by leaning 10 ° or 20 ° with their head up and hips down or standard lithotomy position. The ureter stone was accessed with a semirigid ureteroscope. A 273 micron Holmium: yttrium-aluminum-garnet (Ho: YAG) laser was applied as an energy source set at 1.0 J and a speed of 8-10 Hz."
15745787|NCT04894045|Other|Personalized management|Intraoperative MAP will be maintained at least at the mean nighttime MAP (assessed using preoperative automated blood pressure monitoring). If the mean nighttime MAP is below 65 mmHg, intraoperative MAP will be maintained at least at 65 mmHg.
15745788|NCT04894032|Procedure|Combination of Laparoscopic Uterosacral Ligament and Round Ligament Plication.|Laparoscopic Uterosacral Ligament Plication, Fixation of PVC fascia and the combination with round ligament plication
15745789|NCT04894019|Device|Continuous invasive blood pressure monitoring|Continuous invasive blood pressure monitoring using an arterial catheter
15745790|NCT04894019|Device|Intermittent non-invasive blood pressure monitoring|Intermittent non-invasive blood pressure monitoring using upper-arm cuff oscillometry
15745791|NCT04894006|Behavioral|Community Health Worker (CHW) Home Visit Intervention|The on-site intervention will focus on stress reduction techniques and caregiving skills education for 4 weeks and two monthly caregiver-driven topics for the following two sessions. The education of dementia caregiving skills will include (1) understanding about Alzheimer's and dementias, (2) appropriate communication skills with PWD, (3) daily activities for or with PWD together (e.g., puzzles, writing, reading, singing, taking a walk, etc), and (4) care resources including support groups, adult day centers, or other dementia related social services (legal and financial matters). For stress reduction techniques to be effective, the investigators have installed an app on the smartwatch to remind them to practice mindful breathing exercises two times a day and when needed.
15745792|NCT04894006|Behavioral|Attention Control Group with WIoT Technology|The caregivers randomly assigned to the AC group will be asked to wear the smartwatch during the day time and the smartring during the night for 3 months in order to monitor their physiological measures (heart rate variability, heart rate, activities, and sleep quality). CHW will give AC participants an overview of WIOT instruction at the baseline home visit. Caregivers will also receive resource information regarding Alzheimer's association and local social service information. CHWs will contact them monthly via phone for 6 months answering general questions from participants. CHW will visit participants' home at baseline, 3 months, and 6 months to administer survey assessments.
15745793|NCT04894006|Behavioral|Usual Care|The caregivers randomly assigned to UC group will receive resource information regarding Alzheimer's association and local social service information at the baseline home visit by CHW. CHWs will contact them monthly for 6 months by phone asking general questions from participants. CHWs will visit participants' home at baseline, 3 months, and 6 months to administer survey assessments.
15745794|NCT04893993|Drug|Thiamine|Tablets. 300mg/tablet. Dosage depends on gender and weight
15745795|NCT04893993|Drug|Placebo|Tablets. Same number of tablets as Thiamine
15745796|NCT04893980|Drug|Recombinant human interleukin-2 (rhIL-2)|During Day 0-14, patients in this group will receive treatment with antihistamines at the same dosage as pre-recruitment, together with a low-dose recombinant human Interleukin-2 (rhIL-2) at a dosage of 1 million international units every other day by intramuscular injection (rhIL-2, 1 MIU, im, Qod). During Day 15-28, the injections of rhIL-2 will be continued at the same dosage and the dose of antihistamines may be adjusted according to the control of symptoms.
15745797|NCT04893980|Drug|Control group|During Day 0-14, patients in the control group receive treatment with only antihistamines at the same dosage as pre-recruitment, but no injection of rhIL-2. During Day 15-28, treatment with low dose recombinant human Interleukin-2 (rhIL-2), i.e., 1 million international units every other day by subcutaneous or intramuscular injection (rhIL-2, 1MIU, im, Qod), will be added.
15745800|NCT04893954|Diagnostic Test|Full Spine Radiography|Full Spine Radiography
15745801|NCT04893954|Diagnostic Test|Lumbar spine MRI|Lumbar spine MRI
15745802|NCT04893941|Drug|CM310|IL-4Rα monoclonal antibody
15745803|NCT04893941|Drug|Placebo|Placebo
15745804|NCT04893928|Other|QUECOMIICAT survey|IBD-related knowledge. It will be assessed using the recently validated QUECOMIICAT (Qüestionari Coneixements Malaltia Inflamatòria Intestinal Catalunya) questionnaire (27) originally developed in Spanish. Compared with the most well-known CCKNOW (Eaden JA et al in 1999)(28), it incorporates IBD updated data (29).
15745805|NCT04893928|Other|Self-Efficacy for Appropriate Medication Use Scale|Treatment adherence and compliance. It will be assessed using the Self-Efficacy for Appropriate Medication Use Scale (SEAMS), a 13-item self-administered scale previously translated into Spanish and validated by Bozada-Gutiérrez K et al on a Mexican population (3). According to 13 situations asked by the items, patients stratify the level of confidence about correctly taking their medications: 1, not at all confident; 2, somewhat confident; 3, very confident. The sum of results ranges from 13 to 39 points, where higher scores indicate optimal self-efficacy for taking the pharmacological treatment.
15745806|NCT04893928|Other|ICTs preferences and barriers survey|"Information and communication technologies (ICTs) preferences and barriers. It will be assessed using an ad-hoc inventory designed by the authorship. It has 45 questions mainly answered through a 5-points Likert scale. This inventory was inspired by the surveys used by Mauer M et al on an international population with urticaria (11), and those used by Reich J et al (30) and Chowdhary TS et al (31) on American patients with IBD. Survey approaches aspects related to:
~Frequency of use of ten different ICTs for personal purposes;
~Frequency of use of ten different ICTs for IBD-related purposes;
~A free question about others ICTs that the patient uses for IBD-related purposes;
~Eight specific IBD-related purposes ICTs are used to;
~Assessment of ICTs for eight IBD-related purposes;
~Eight Features an IBD-related App must comprehend."
15745898|NCT04893109|Drug|trastuzumab-emtansine|intravenous infusion
15745899|NCT04893109|Drug|Trastuzumab SC|Muscular injection
15745900|NCT04893109|Drug|Paclitaxel|intravenous infusion
15746540|NCT04887896|Device|GS500|Device: GS500
15745807|NCT04893928|Other|Focus group and IBD mobile App for health support (MAHS) development and validation|In stage II, a qualitative study will be performed using focus group discussion to explore the experiences and perceptions of patients with IBD using ICTs for health support in different contexts. Focus groups will be established following the Krueger and Casey guidelines (32). Collected data will address the development of an IBD MASH. The developed IBD MASH will be validated on a randomised pilot study along stage III. Methodology and ethical aspects of stage II and III will be defined in another proposal, after stage I preliminary findings.
15745808|NCT04893915|Biological|Cytokine-induced memory-like NK cells|Cell product processing is performed at the Siteman Cancer Center Biological Therapy Core or another FACT-accredited cellular therapy production facility that can manufacture the product per the IND CMC.
15745809|NCT04893915|Drug|Fludarabine|-Lymphodepleting regimen
15745810|NCT04893915|Drug|Cyclophosphamide|-Lymphodepleting regimen
15745811|NCT04893915|Procedure|Donor Leukapheresis|-Apheresis will be performed via peripheral IVs or central line, as determined by the apheresis team.
15745812|NCT04893915|Drug|Interleukin-2|-IL-2 will start approximately 2-4 hours after the NK cell infusions.
15745813|NCT04893902|Device|medit intra oral scanner|ear scanning with intra oral scanner
15745814|NCT04893889|Diagnostic Test|Shear-wave elastography|Myocardial shear wave elastography to assess myocardial stiffness by non-invasively quantifying diastolic myocardial elasticity.
15745815|NCT04893863|Drug|Standard dressing|Topical antibiotic ointment (Polysporin™ or formulary equivalent) and non-adherent petrolatum fine-meshed gauze (ADAPTIC™) applied every Monday, Wednesday and Friday (or equivalent).
15745816|NCT04893863|Drug|PluroGel|A 0.5 cm layer of PluroGel® followed by the above standard dressing. In addition, this will be covered with moistened gauze, kept moist twice daily. (The additional factors are the use of PluroGel® and moistened gauze. Standard dressing will continue to be used.)
15745817|NCT04893850|Behavioral|BRIDGE Therapy Program|The BRIDGE Therapy Program is a novel manualized therapy that incorporates key parenting concepts and related Dialectical Behavior Therapy (DBT) modules. The primary aim of the program is to improve parent well-being and promote supportive parenting practices. There are two components of the program: 1) the DBT section, which will follow the DBT Skills Training Manual 2nd Edition and target parental mental health symptomology, and 2) the parent skill training materials, which have been designed to correspond to the four core DBT modules (i.e., Mindfulness, Emotion Regulation, Distress Tolerance, and Interpersonal Effectiveness) and to promote self-regulatory skill development and a positive parent-child relationship.
15745818|NCT04893850|Behavioral|Community Services as Usual Clinical Referral list|The community services as usual clinical referral list provides information on accessing psychological and family support services in Winnipeg. This resource is used to locate: crisis, distress, and support phone lines, counselling and peer-support resources, and free apps relating to mindfulness and meditation.
15745819|NCT04893837|Device|Standard care plus infrascans|Hourly infrascans to detect expanding intracranial hematomas
15745820|NCT04893824|Device|Grappler® Interference Screw System|Foot and/or ankle procedure involving soft tissue attachment to bone using the Grappler® Interference Screw System
15745822|NCT04893798|Combination Product|Sayana Press|Sayana Press is a drug-device combination and is considered a medical product in the EU.
15745823|NCT04893785|Drug|Cabozantinib and Temozolomide|"Patients enrolled will receive study medication until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever comes first.
~Patients will be required to attend clinic on Day 1, Day 8, Day 14 and Day 22 of every 4 week cycle.
~Patients will return to clinic at 30 days (+/- 5 days) of their last dose of cabozantinib or temozolomide (whichever is discontinued last), for an end of treatment visit.
~Following their end of treatment visit patients will be followed-up 3-monthly during routine clinic appointments to collect data on further anti-cancer treatment and survival. Follow-up will continue until 6 months after the last patient stops study treatment or up to 18 months after the last patient is randomised, whichever is sooner."
15745824|NCT04893772|Dietary Supplement|Intermittent fasting|"Three fasting days a week, whereby participants consume 600-800 kcal/day from 4 meal replacement products: breakfast, lunch, a snack and dinner. During the other 4 non-fasting smart days each week, participants are instructed to consume 2 x 300 kcal meals and 2 x 100 kcal snacks, from a selection of recipes, plus one meal of their own choosing."
15745826|NCT04893746|Dietary Supplement|Lactobacillus plantarum TWK10-L|Low dose: 2x1010 CFU/day
15745827|NCT04893746|Dietary Supplement|Maltodextrin|0x1010 CFU/day
15745828|NCT04893746|Dietary Supplement|Lactobacillus plantarum TWK10-H|High dose: 6x1010 CFU/day
15745829|NCT04893733|Drug|Vitamin B Complex|"Patients with established AKI will be randomized to received IV vitamin B complex each 1 hours for 5 consecutive days versus placebo.
~Every patients will also received Institution standard of care for AKI"
15745830|NCT04893720|Procedure|Lumbar fusion|Transforaminal Lumbar Interbody Fusion of the SPECT/CT positive lumbar degeneration
15745831|NCT04893707|Biological|CM310|600mg for 1st dose, and then 300 mg, every 2 weeks, SC
15745832|NCT04893681|Other|Fluoridated bottled drinking water|Study participants are asked to consume study water, as frequently and in amounts as necessary or desired, whenever they drink water (e.g., as plain water or mixed with other ingredients) or use water in food preparation.
15745833|NCT04893681|Other|Non-fluoridated drinking water|Study participants are asked to consume study water, as frequently and in amounts as necessary or desired, whenever they drink water (e.g., as plain water or mixed with other ingredients) or use water in food preparation.
15745834|NCT04893668|Other|Depression|Any participants who develop depression symptoms according to DSM 5 criteria
15745835|NCT04893668|Other|Anxiety|Any participants who develop anxiety symptoms according to DSM 5 criteria
15745836|NCT04893655|Drug|Dobutamine Hydrochloride|dobutamine infusion will be started at 2mcg/kg/min after min 10 minutes dobutamine infusion will be raised to 5mcg/kg/min
15745837|NCT04893642|Procedure|Suture rectopexy|
15745838|NCT04893642|Procedure|resection rectopexy|
15745839|NCT04893642|Procedure|Delorme's operation|
15745840|NCT04893642|Procedure|Altemeier's operation|
15746541|NCT04887896|Device|Placebo|Device: Placebo
15745843|NCT04893616|Other|Integration of vaccination services into delivery services|The purpose of the work is to integrate readily available birth dose vaccinations (Oral Polio and the Tuberculosis vaccine) currently given in a separate clinic into the maternity delivery services through improved training, checklist, and job aides.
15745844|NCT04893603|Device|Transcatheter Aortic Valve System|Procedure: Transcatheter aortic valve replacement
15745845|NCT04893590|Behavioral|Fatigue self-management SMS intervention|Participants will set up an initial goal for the SMS intervention related to fatigue management, and prior to beginning the intervention they will be trained to use the SMS system. Participants will receive text messages each day, providing tips and techniques to help self-manage fatigue. Weekly the participants will be asked to provide feedback regarding their fatigue levels and their patient activation will be re-assessed at the halfway point of intervention.
15745846|NCT04893577|Drug|EDTA|Patients will treat their cold sore with EDTA eye drops based upon their randomization.
15745847|NCT04893577|Drug|Abreva|Patients will treat their cold sore with Abreva based upon their randomization
15745848|NCT04893564|Biological|bone marrow sample|8 to 13 ml bone marrow sample for frozen storage within one of the 5 certified biobank of the canceropole area.
15745849|NCT04893564|Biological|blood sample|20 ml blood sample for frozen storage within one of the 5 certified biobank of the canceropole area.
15745850|NCT04893551|Biological|Tilvestamab|Tilvestamab will be administered as IV infusion.
15745851|NCT04893538|Diagnostic Test|First analysis: Lymphocyte count > or = 1500 cells per microlitre, second analysis: Monocyte count < 720 cells per microlitre and third analysis: Lymphocyte/Monocyte ratio > or = 2.9|Intravenous blood sampling from participants for complete blood count to obtain Lymphocyte count, Monocyte count and Lymphocyte/Monocyte Ratio
15745852|NCT04893538|Diagnostic Test|First analysis: Lymphocyte count < 1500 cells per microlitre, second analysis: Monocyte count > or = 720 cells per microlitre and third analysis: Lymphocyte/Monocyte ratio < 2.9|Intravenous blood sampling from participants for complete blood count to obtain Lymphocyte count, Monocyte count and Lymphocyte/Monocyte Ratio
15745853|NCT04893525|Drug|Buprenorphine/naloxone|Buprenorphine/naloxone is a first line, evidence-based opioid agonist therapy that improves mortality for people with opioid use disorder, and that has been demonstrated to be effective at retaining people in addictions care and decreasing illicit opioid use when initiated from EDs.
15745854|NCT04893512|Drug|Orally Suspension of CoV2-OGEN1|CoV2-OGEN1 will be supplied as a 10mL oral suspension in a plastic bottle containing 50-200 mcg of formulated drug
15745855|NCT04893499|Behavioral|Chios mastic water|Participants randomized to this intervention arm will be provided with a sparkling water enriched with the natural mastic aqueous extract (0.06%), a by-product of Chios mastic processing, and will be asked to consume it daily (3 bottles of 200 mL each) for 3 months. Participants will also be instructed to keep their medication constant, avoid the reception of any dietary supplement and preserve their typical lifestyle habits.
15745856|NCT04893499|Behavioral|Placebo water|Participants randomized to this intervention arm will be provided with a standard sparkling water and will be asked to consume it daily (3 bottles of 200 mL each) for 3 months. Participants will also be instructed to keep their medication constant, avoid the reception of any dietary supplement and preserve their typical lifestyle habits.
15745857|NCT04893499|Behavioral|Chios mastic fruit juice|Participants randomized to this intervention arm will be provided with a sparkling fruit juice enriched with the natural mastic aqueous extract (0.55%), a by-product of Chios mastic processing, and will be asked to consume it daily (3 bottles of 200 mL each) for 3 months. Participants will also be instructed to keep their medication constant, avoid the reception of any dietary supplement and preserve their typical lifestyle habits.
15745858|NCT04893499|Behavioral|Placebo fruit juice|Participants randomized to this intervention arm will be provided with a standard sparkling fruit juice and will be asked to consume it daily (3 bottles of 200 mL each) for 3 months. Participants will also be instructed to keep their medication constant, avoid the reception of any dietary supplement and preserve their typical lifestyle habits.
15745861|NCT04893473|Device|IscAlert|3 IscAlert sensors in the limb undergoing surgery and two control sensors in the opposite limb are inserted and carbon dioxide is measured continuously.
15745863|NCT04893447|Behavioral|SPI+|Suicide prevention hotline follow-up specialists will call participants to (1) conduct a brief suicide risk assessment; (2) review and discuss the participant's connection and support plan or safety plan; and (3) provide referrals to social services or other support with treatment engagement, if indicated. Participants will receive at least one and optional additional phone calls, generally delivered according to the following schedule: days 3, 7, 14, 30, 60, 90. Modifications may be made to the schedule due to weekends, holidays, or participant availability, and additional calls may be scheduled as desired by the participant. The follow-up will stop once the participant is successfully engaged in outpatient treatment or does not desire further follow-up support.
15745864|NCT04893447|Behavioral|SP+CC (Caring Contacts)|SP+CC follow-up includes one phone conversation with a suicide prevention hotline follow-up specialist and a series of personalized caring messages sent over the course of 12 months via text or email (based on participant preference). Caring contacts will generally be sent according to the following schedule: 3 in the first week, 6 weekly, 6 bi-weekly, 4 monthly; 2 bi-monthly, and one each for the participant's birthday, Thanksgiving, Christmas, and New Year's (total of 25 over 12 months). Slight variation in the schedule is allowed. There is no expectation that participants respond to the text messages; if they do, follow-up specialists reply to any incoming texts. Replies are individually-tailored and caring.
15745865|NCT04893434|Drug|Gadobutrol|Each patient will undergo 3 Gadavist injections. The intravenous injection of the GBCA Gadobutrol (Gadavist, Bayer Healthcare) at 0.1 mL/kg body weight (0.1 mmol/kg), administered as a bolus at a flow rate of approximately 2 mL/s. Each volunteer will undergo 1 and each patient 2 research Gadobutrol injections (the 3 injections mentioned in the protocol for patients is to account for the fact they will have had 1 injection as part of their standard of care, but the study only includes 2 research injections).
15745901|NCT04893096|Drug|MOR202|Each patient will be treated for 24 weeks and received a total of 9 doses. During the first treatment cycle, MOR202 will be administered weekly. For the following 5 months, patients will receive one dose every 4 weeks.
15745866|NCT04893434|Diagnostic Test|MRI|All subjects will be imaged on the same 3T MRI scanner (GE Healthcare, USA) at MSK for all examinations. For SA1, subjects will undergo a single research DCE-MRI exam. Patients in SA2 will undergo a standard of care pelvic MRI at baseline (which includes DCE-standard) in accordance with standard clinical operating procedures at MSK.
15745867|NCT04893421|Device|MOLLI Localization|Patients will be implanted with a MOLLI seed using a specialized introducer needle under imaging guidance. A special handhold probe and detection system will be used intraoperatively to assist in excision.
15745868|NCT04893408|Other|observational study|
15745869|NCT04893395|Other|Pharmacogenomic Screening|"First telehealth appointment:
~Pharmacogenomics education and informed consent
~Medical history
~Sample collection
~Second telehealth appointment:
~Results of pharmacogenomic testing
~Utility and limitations of pharmacogenomic testing
~Patient-specific potential impacts on current or future medication therapies
~Answering of patient questions
~Referral to mental health provider(s) for treatment-specific recommendations"
15745870|NCT04893382|Procedure|PlasmaLyte for fluid resuscitation|Fluid resuscitation is a critical and essential part in the treatment of severely burned patients. Patients randomized for this arm will be submitted to PlasmaLyte infusion (as clinically prescribed).
15745871|NCT04893382|Procedure|Ringer's Lactate for fluid resuscitation|Fluid resuscitation is a critical and essential part in the treatment of severely burned patients. Patients randomized for this arm will be submitted to Ringer's Lactate infusion (as clinically prescribed).
15745872|NCT04893369|Other|The Low Back Pain and Disability Drivers Management model|"PTs assigned to the intervention arm will undergo a one-day training specific to the PDDM model. The objectives of the workshop are 1) to acquire knowledge on the functioning of the PDDM model by identifying the different domains of the model, and the specific elements that are deemed problematic for a given patient to appropriately establish the clinical profile and 2) to adopt a structured approach to manage and select appropriate interventions to address problematic areas. The model is composed of five domains upon which the clinician can base his assessment and orientate treatment allocation and includes: 1) nociceptive pain drivers, 2) nervous system dysfunction (NSD) drivers, 3) comorbidity drivers, 4) cognitive-emotional drivers and 5) contextual drivers. This profiling will inform and lead the clinician's treatment approach based on the combined contribution of each domain driving the experience of pain and disability."
15745873|NCT04893369|Other|Low back pain clinical practice guidelines|For the PTs allocated to the control arm, they will participate in a three-hour training on the most recent CPGs on the management of LBP. The content of the training is based on the results of a thorough review of the literature summarizing the different recommendations from CPGs with a focus on the rehabilitation management of LBP. The objectives of the workshop are 1) to acquire knowledge about the recommendations from the most recent and high-quality CPGs for the management of LBP and 2) to foster their integration into clinical practice. An interactive workshop will be conducted to present the results of the review of the literature with the help of case-studies to facilitate implementation and promote active participation.
15745874|NCT04893356|Genetic|O6-methylguanine-DNA methyltransferase (MGMT) promoter methylation and MGMT expression on dacarbazine treated sarcoma patients|"Tumor samples of Leiomyosarcoma and Solitary Fibrous Tumours patients, dacarbazine (as single agents or in combination with anthracyclines) treated, will be obtained from and characterized by the Pathology Unit of the Istituto Nazionale Tumori Fondazione Pascale in Naples, Campus Biomedico of Rome, Istituto Oncologico of Bari and University of Palermo.
~Glioblastomas control samples will be obtained from CEINGE-Biotecnologie Avanzate, in Naples and characterized by the Pathology Unit of the University of Naples Federico II.
~After biopsy or surgical resection, the tissues were fixed in 10% formalin and included in paraffin blocks. All patients partecipating in this study provided informed consent."
15745875|NCT04893343|Other|Antibiotic treatment|Antibiotic treatment
15745876|NCT04893343|Other|No antibiotic treatment|No antibiotic treatment
15745877|NCT04893330|Dietary Supplement|pepticate syneo|follow up of pepticate syneo for one month
15745878|NCT04893317|Device|Ablation in the ventricles with cryoablation|The Adagio Medical VT Cryoablation System is indicated for the treatment of monomorphic ventricular tachycardia by ablation of arrhythmogenic tissue that drives and maintains these arrhythmias
15745879|NCT04893304|Device|co2 laser|types of laser
15745880|NCT04893291|Device|Everolimus Eluting Stent|Patients assigned to this Arm will have an EES implanted after pre-dilatation, the angiography will be conducted as standard of care
15745881|NCT04893291|Device|Sirolimus Coated Balloon|Patients assigned to this Arm will be treated with Magic Touch Drug Coated Balloon (DCB) after pre-dilatation, the angiography will be conducted as standard of care
15745882|NCT04893278|Other|Virtual reality|Use of Virtual reality goggles during procedure
15745883|NCT04893265|Behavioral|Text Messaging Only|Active Comparator
15745884|NCT04893265|Behavioral|INFORMED|Experimental
15745885|NCT04893252|Drug|durvalumab and vactosertib|durvalumab IV Q4W in combination with vactosertib PO bid (5 days a week)
15745886|NCT04893239|Biological|LMN-201|Components of LMN-201
15745888|NCT04893213|Other|Manipulation of availability of lower energy meal options|Menus provided differ in % of menu options that are higher vs. lower in energy
15745889|NCT04893187|Drug|SSS17|SSS17 is a novel small molecule compound which stimulates erythropoiesis through inhibition of hypoxiainducible factor- prolyl hydroxylases( HIF-PH). It is being developed for the treatment of anemia in patients with chronic kidney disease.
15745890|NCT04893187|Drug|Placebo|Matched placebo.
15745891|NCT04893174|Biological|UMC119-06-05|"Subjects will receive a single-dose IA injection of UMC119-06-05 followed by an IA injection of hyaluronic acid.
~Cohort 1: Low does UMC119-06-05 Cohort 2: High does UMC119-06-05"
15745892|NCT04893174|Device|Hyaluronic acid|IA injection of hyaluronic acid.
15745893|NCT04893161|Drug|Belimumab|All patients with SLE will be enrolled in one year and administrated belimumab 10mg/kg intravenous infusion over 1 hour on days 0, 14, and 28, and every 28 days through week 48.
15745894|NCT04893148|Drug|IGlarLixi|Changing to iGlarLixi from insulin glargine
15745902|NCT04893070|Other|Questionnaires COVID+|"1 questionnaire on COVID-19 symptomatology and quality of life 12 months after COVID-19 first symptoms
~1 questionnaire on quality of life 18 months after COVID-19 first symptoms"
15745903|NCT04893070|Other|Questionnaires COVID-|"1 questionnaire on quality of life at enrollment
~1 questionnaire on quality of life 6 months after enrollment"
15745904|NCT04893044|Behavioral|Video|"The video was a 3 minutes and based on inoculation theory to modify behavior towards moderating the effect of alcohol use as opposed to advising no use at all."
15745905|NCT04893031|Drug|Tocilizumab|400mg or 800 mg IV tocilizumab treatment according to patient clinical severity
15745906|NCT04893018|Biological|Efineptakin alfa|Given IM
15745907|NCT04892992|Behavioral|DFG|
15745908|NCT04892979|Other|Cardiopulmonary exercise (centre-based)|Depending on the preference of participants, they can either choose to join three 60-minute centre-based sessions plus two sessions of 30-minute home exercise per week, or two 60-minute centre-based sessions plus four sessions of 30-minute home exercise per week. Each session will include warm-up and cool-down exercises, aerobic exercises, and progressive strengthening exercises prescribed based on individual ability (Table 1). Aerobic exercises will be performed at 60-75% (up to 85% for fit individuals) of the predicted maximum heart rate. The respective rate of perceived exertion during exercise will be maintained between 4 and 6 out of 10 on the Borg CR scale [10], indicating moderate to strenuous exercise levels. Additionally, physiotherapists will provide education related to COVID-19, energy conservation, and stress management during the program.
15745909|NCT04892979|Other|Cardiopulmonary exercise (online-based)|Participants in the OBR group will attend one face-to-face session to learn how to use a mobile application (app) followed by 6 weeks of home exercises. The online treatments will be delivered via the Caspar Health e-system, a German-designed Internet-based system, is available for desktop PCs and as a mobile app for both iOS and Android smartphones. This system will enable patients to follow their therapists' treatment plans in an asynchronous manner. The OBR programme will last for 6 weeks. Participants will be instructed to perform 40 minutes of structured exercises 6 times per week. In the first week, six 40-minute online exercise sessions will be delivered through push notifications on the mobile app.
15745910|NCT04892966|Diagnostic Test|TXI Light Imaging|Standard Colonoscopy using TXI imaging
15745911|NCT04892966|Diagnostic Test|WLI Imaging|Standard Colonoscopy using White Light Imaging
15745912|NCT04892953|Drug|Carboplatin|Given IV
15745913|NCT04892953|Biological|Durvalumab|Given IV
15745914|NCT04892953|Drug|Gemcitabine|Given IV
15745915|NCT04892953|Procedure|Local Consolidation Therapy|Undergo LCT
15745916|NCT04892953|Drug|Nab-paclitaxel|Given IV
15745917|NCT04892953|Drug|Paclitaxel|Given IV
15745918|NCT04892953|Drug|Pemetrexed|Given IV
15745919|NCT04892953|Other|Quality-of-Life Assessment|Complete questionnaire
15745920|NCT04892953|Other|Questionnaire Administration|Complete questionnaire
15745921|NCT04892940|Device|Virtual Reality (VR) technique|"The PICO G2 4k helmet from the Chinese manufacturer Pico which is an autonomous virtual reality helmet will be used.
~The sessions proposed last 20 minutes with a child pain protocol. The teenager will be able to choose his universe (forest, beach, mountain, aquatic, space), the voice that accompanies him (man, woman, none), the sound environment of music therapy (6 to choose from).
~Each patient in the experimental group benefits from a virtual reality program including two daily sessions during their stay in the continuing care unit from the first post-operative day until the third post-operative day. Each session is proposed by a nurse anesthetist from the pain team and trained in the proper use of the equipment.This virtual reality program will be added to the standard analgesic protocol for the experimental group."
15745922|NCT04892940|Drug|Analgesic protocol|"Patients randomized in the control group receive the usual analgesic protocol of the department postoperatively."
15745924|NCT04892901|Procedure|c-ESPB|In the c-ESPB group an ultrasound-guided ESPB will be performed by the attending anaesthesiologist at the end of surgery, immediately after the last surgical stitch and before extubation. After an initial bolus of 20 ml 0,2% ropivacaine, a catheter will be left in place into the fascial plane deep to the erector spinae muscle to ensure continuous infusion (5ml/h for 48 hours) of the local anesthetic.
15745925|NCT04892901|Procedure|c-SAPB|In the c-SAPB group SAPB will be performed by surgeons intraoperatively, immediately before the closure of chest wall muscle planes, by injection of 20 ml 0,2% ropivacaine into the fascial plane above the Serratus Anterior muscle. After the initial bolus, a catheter will be left in place into the superficial fascial plane of the Serratus Anterior muscle to ensure continuous infusion (5ml/h for 48 hours) of the local anesthetic.
15745926|NCT04892901|Procedure|ICNB|"In the ICNB-group ICNB will be performed by surgeons intraoperatively, immediately before chest drain placement, by injection of 20 ml of 0,2% ropivacaine into the intercostal spaces (III-VII), below the parietal pleura, under direct visualization of the neurovascular bundle. The one-shot ICNB will be associated in this group with intravenous administration of tramadol (300 mg/48 h) by elastomeric pump."
15745927|NCT04892888|Biological|COVID-19 Vaccine|COVID-19 Vaccine Intramuscular Injection
15745928|NCT04892875|Drug|Zimberelimab|Zimberelimab will be administered at a dose of 360 mg IV on Day 1 of each 21-day cycle for up to 11 cycles.
15745929|NCT04892875|Drug|Etrumadenant|Etrumadenant will be administered at a dose of 150 mg by mouth once daily on days 1-21 of each 21-day cycle for up to 11 cycles.
15745930|NCT04892875|Drug|Cisplatin|Concurrent weekly cisplatin and radiation will be administered as part of the subject's standard of care. Cisplatin and radiation will be initiated on the same day and continue for up to 7.5 weeks.
15745931|NCT04892875|Radiation|Radiation|Concurrent weekly cisplatin and radiation will be administered as part of the subject's standard of care. Cisplatin and radiation will be initiated on the same day and continue for up to 7.5 weeks.
15745963|NCT04892589|Other|Proprioceptive thumb exercises.|Exercises for recognition of thumb position and thumb force sense.
15745964|NCT04892576|Other|Physical Therapy|"The control group recieved the standard physical rehabilitation program conducted for 45 minutes, twice a week for eight consecutive weeks, and consisted of advanced balance training, gait training, postural and flexibility exercises, and strength training exercises.
~The SSC group received the same program in addition to the SSC exercises for 30 minutes, two times per week for eight successive weeks"
15745932|NCT04892862|Procedure|SCAHOİD GRAPHONAGE WITH AUTOGRAPH FROM DİSTAL RADİUS BY DORSAL APPROACH|ON GENERAL OR LOCAL ANESTESİA PATİENT N SUPİNE POSTİON EFFECTED WRİST ON ARM TABLE . LISTER TUBERCULA WITH 3 CM PROXIMAL AND 3 CM DISTAL IN INCISION MADE UNDER THE SKIN. 2,3 EXTENSOR COMPARTMENTS RADIAL 4. THE EXTENSON COMPARTMENT IS EARTHED TO ULNAR A AND THE WRIST JOINT CAPSULE IS REACHED. THEN THE CAPSULE IS OPENED AND THE SCAPHOLID PROXIMAL AND MIDDLE POLE IS VIEWED. THE PERSODOARTHOSIS FIELD IS REGENERATED WITH THE TURRET AND TURR ENGINE. Following the same incision ON DISTAL UNDER RADIUS metaphyseal area of 2CM. 2X2 centimeter WINDOW opened to get spongios bone GREFt, greft added in to field of pseudoarthrosis.After scaphoid HEIGHT AND anatomy recovered it has fixated one headless mini acuttrack screw under fluoroscopy guidance .skin and subcutaneous tissue closed with non absorbabl sutures.
15745933|NCT04892862|Procedure|SCAHOİD GRAPHONAGE WITH AUTOGRAPH FROM DİSTAL RADİUS BY VOLAR APPROACH|ON GENERAL OR LOCAL ANESTESİA PATİENT N SUPİNE POSTİON EFFECTED WRİST ON ARM TABLE . İNCİSİON STARTS 2 CM RADİAL TO SCAPHOİD TUBERCULE EXTENTS ITS 3 CM PROXİMAL . AFTER PASİNG SUBCUTANEOUS TİSSUE , FCR AND RADİAL ARTERY ARE İDENTİFİED AND DİVİDED SEPERATLY THEN THE CAPSULE IS OPENED AND THE SCAPHOLID PROXIMAL AND MIDDLE POLE IS VIEWED. THE PERSODOARTHOSIS FIELD IS REGENERATED WITH THE TURRET AND TURR ENGINE. Following the same incision WİTH PASSİNG PRONATOR QUADRATUS MUSCLE , ON DISTAL UNDER 2 CENTİMETER OF RADIUS metaphyseal area . 2X2 centimeter WINDOW opened to get spongios bone GREFt, greft added in to field of pseudoarthrosis.After scaphoid HEIGHT AND anatomy recovered it has fixated one headless mini acuttrack screw under fluoroscopy guidance .skin and subcutaneous tissue closed with non absorbabl sutures.
15745934|NCT04892849|Other|Conventional Therapy acc. to prevailing clincal approved schemes|The study is observational. The treatment-plan of the underlying disease remains unchanged. The treatment of the patient is according to the prevailing clinical approved schemes at the respective entities. Blood will be drawn from patients at several time points during and after RT and ICI for detailed immunomonitoring of the patients.
15745935|NCT04892836|Other|Training|Resistance training (4 different exercises, leg press, leg extension, leg curl, and seated calf raises)
15745936|NCT04892823|Procedure|Biospecimen Collection|Undergo collection of blood sample
15745937|NCT04892823|Other|Electronic Health Record Review|Review of medical records
15745938|NCT04892823|Other|Questionnaire Administration|Complete questionnaires
15745939|NCT04892810|Procedure|Percutaneous ablation|Hepatic Percutaneous Ablation with radiofrequency or microwave
15745940|NCT04892797|Other|Covid-19+ observational|This is observational--there is no intervention
15745941|NCT04892784|Device|Press tack needle acupuncture|Pyonex press tack needle sized 0.20x1.2mm
15745942|NCT04892758|Drug|Formoterol fumarate 10 mcg|Formoterol fumarate 10 mcg dispensing claim is used as the reference group.
15745943|NCT04892758|Drug|Mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID|Mometasone furoate/formoterol fumarate combination MDI 200/10 mcg BID dispensing claim is used as the exposure group.
15745944|NCT04892732|Drug|Budesonide|Budesonide dispensing claim is used as the reference group.
15745945|NCT04892732|Drug|Budesonide-Formoterol|Budesonide-Formoterol dispensing claim is used as the exposure group.
15745946|NCT04892719|Diagnostic Test|Fluoroscopic chest imaging with 4Dx technology software analysis|4DxV utilizes a novel software algorithm to analyze data from cinefluoroscopy images to calculate regional ventilation and pulmonary function changes. Cinefluorography uses a fluorescent screen with X-rays to make real-time moving images the lung described below. This is the same x-ray fluoroscopy that is used in clinical imaging and the fluoroscopic imaging time is approximately 1 minute leading to an effective radiation dose of 2 mSv (200 mRem). This is significantly lower that the radiation exposure from a standard chest CT. Fluoroscopy images are acquired at each of five views for approximately enough time to capture at least one complete, continuous breath. The subject is required to remain in the same position for each of the five fluoroscopy imaging sequences. These images will be analyzed by the novel 4Dx technology to provide the 4Dx lung function analysis report.
15745947|NCT04892706|Drug|IDP-126 Gel|Gel applied to face once daily in the evening.
15745948|NCT04892706|Drug|IDP-126 Vehicle Gel|Gel applied to face once daily in the evening.
15745949|NCT04892706|Drug|Epiduo® Forte Gel|Gel applied to face once daily in the evening.
15745950|NCT04892693|Drug|Talazoparib Oral Capsule|- Patients will receive Talazoparib 1 mg orally once daily continuously, with or without food. Laboratory values will be monitored every 4 weeks until progression or unacceptable toxicity. Dose modifications should be made based on the observed toxicity
15745951|NCT04892680|Behavioral|Online Diabetes Self-Management Education and Support (DSMES) Program|Digital delivery of a DSMES program designed to build self-management skills and support diabetes management. Recipients have access to online curriculum, a live CDCES, group-based communication forums, and connected technology to track weight, food intake, physical activity and glucose levels.
15745952|NCT04892667|Other|intervention|The patient participating in the study needs to respect a 12-hour fasting period, a high protein and a low-carbohydrate diet prior to performing PET/CT in order to limit physiological 18F-FDG myocardial fixation.
15745953|NCT04892654|Drug|Doravirine|Antiretroviral, Non-nucleoside Reverse Transcriptase Inhibitor
15745954|NCT04892654|Drug|Dolutegravir|Antiretroviral, Integrase strand transfer inhibitors
15745955|NCT04892654|Other|Triple cART regimen|Participant standard triple cART regimen
15745956|NCT04892641|Drug|Epetraborole|Epetraborole hydrochloride 250 mg tablets for oral administration
15745957|NCT04892641|Drug|Placebo|Matching placebo for 250 mg epetraborole hydrochloride tablets for oral administration
15745958|NCT04892628|Other|Progressive resistance training|Resistance training of upper limb and lower limb muscles. Resistance will be increased on a weekly basis. Dumbbells and therabands will be used to provide resistance.
15745959|NCT04892628|Other|Aerobic training|The control group will be administered a standard physical therapy intervention program which will consist of active muscle stretching and aerobic exercises.
15745960|NCT04892615|Device|drainage tube was removed on 5th days after surgery.|drainage tube was removed on 5th days after surgery.
15745961|NCT04892615|Device|drainage tube was removed on 7th days after surgery.|drainage tube was removed on 7th days after surgery.
15745962|NCT04892602|Diagnostic Test|Serum vitaminDlevel|Investigate about fibromyalgia in psoiaritic and rheumatiod arthritis patients ...and assesment of seum vitamin D level
15746892|NCT04885075|Drug|I/N Midazolam|intranasal midazolam 0.2mg/kg/dose stat
15745967|NCT04892550|Other|Denneroll traction|The participants will be instructed to lie flat on their back on the ground with their knees slightly bent at 20-30° for comfort and arms gently folded across their stomach. The examiner will position the apex of the Denneroll in one of three regions: lower thoracic (T9-T12), mid-thoracic (T5-T8), and upper-thoracic (T1-T4) depending on the apex of each participant's thoracic kyphosis deformity. For lower thoracic kyphosis (T9-T12) the Denneroll is turned 180° so the peak contacts the lower thoracic spine (T10) while the tapered end supports the mid thoracic region
15745968|NCT04892550|Other|Multimodal Program|The multimodal program consists of physical pain relief methods, thoracic spine manipulation, myofascial release, and therapeutic exercises.
15745969|NCT04892537|Device|Coronary Sinus Reducer|Coronary Sinus Reducer implantation according to standard clinical protocols
15745970|NCT04892537|Procedure|Placebo Procedure|A placebo procedure involving venous sheath implantation in the right internal jugular vein without proceeding to CSR implantation
15745971|NCT04892524|Other|Virtual multidisciplinary review|The virtual multidisciplinary review involves participants being reviewed by a multi-disciplinary team of specialist doctors, nurses and radiologists in a virtual environment. The team will analyse radiologic scans and make a recommendations for any follow-up scans, procedures or appointments that may be required
15745972|NCT04892511|Other|Adjusted medication|"In patients randomized to perfusion optimization, medication will be adjusted to maintain blood pressure according to the degree of recanalization:
~Patients with TICI 2b: systolic blood pressure 140-160 mmHg.
~Patients with TICI 2c-3: systolic blood pressure <140 mmHg.
~Hypotensive drugs will be used when necessary. Intravenous labetalol is the treatment of choice, administered as a bolus or intravenous infusion. Alternative: urapidil (bolus or continuous infusion pump). If both drugs cannot be used or are insufficient, sodium nitroprusside can be used.
~Hypertensive drugs for TICI2b patients whose target pressure is 140-160mmHg and are below this range. Initially, a bolus of physiological saline or 100cc Plasmalyte® will be administered. If this treatment is not effective enough (blood pressure measurements persist <140 mmHg), intravenous phenylephrine will be administered."
15745973|NCT04892498|Radiation|Hypofractionated radiotherapy|10-24Gy/5-8Gy/2-3f
15745974|NCT04892498|Drug|PD-1 inhibitor|q3w, until PD
15745975|NCT04892498|Drug|GM-CSF|200μg, D1-D7, ≥8 cycles
15745976|NCT04892498|Drug|IL-2|at a dose of 2 million IU, D8-D14, ≥8 cycles
15745977|NCT04892472|Device|NovoTTF-200T|All patients enrolled in the study will receive TTFields treatment, delivered for at least 18 hours a day on average using NovoTTF-200T together with pembrolizumab, a standard immunotherapy agent, which is delivered intravenously.
15745978|NCT04892459|Biological|Recombinant SARS-CoV-2 Ad5 vectored vaccine|This vaccine contains 5×10^10 virus particles of recombinant replication defective human type 5 adenovirus expressing SARS-CoV-2 S protein, which is produced by CanSino Biologics Inc. It is a liquid dosage form, 0.5 ml / bottle.
15745979|NCT04892459|Biological|Inactive SARS-CoV-2 vaccine (Vero cell)|This vaccine contains 600 SU of SARS-CoV-2 antigen, which is produced by Sinovac Research & Development Co., Ltd. 0.5 ml / bottle.
15745980|NCT04892446|Biological|Magrolimab|Administered IV
15745981|NCT04892446|Drug|Daratumumab|Administered either SC or IV
15745982|NCT04892446|Drug|Pomalidomide|Administered orally
15745983|NCT04892446|Drug|Dexamethasone|Administered orally
15745984|NCT04892446|Drug|Bortezomib|Administered either SC or IV
15745985|NCT04892420|Drug|Dexamethasone|The patients receive 20ml plain bupivacaine (0.5%) + 8 mg dexamethasone (2ml) in adductor canal block after spinal anesthesia.
15745986|NCT04892420|Drug|Dexmedetomidine|The patients receive 20 ml plain bupivacaine(0.5)+25 microgram dexmedetomidine( diluted in 2 ml normal saline) in adductor canal block after spinal anesthesia .
15745987|NCT04892420|Drug|Magnesium sulfate|The patients receive 20 ml plain bupivacaine(0.5)+200 milligram magnesium sulphate (2 ml of magnesium 10%) in adductor canal block after spinal anesthesia.
15745988|NCT04892420|Drug|Bupivacain|The patients receive 20ml plain bupivacaine (0.5%) + 2 ml of Normal saline in adductor canal block after spinal anesthesia.
15745989|NCT04892407|Device|Algeness® DF 3.5%|dermal filler CE Mark approved for treatment of cheek and midface volume loss
15745990|NCT04892407|Device|Juvéderm Voluma|dermal filler CE Mark approved for treatment of cheek and midface volume loss
15745991|NCT04892394|Other|Information Types Before Endodontic Treatment|The first aim of this study is to compare the effect of detailed video information or basic verbal information on the anxiety levels of patients by using anxiety scales before treatment. The second aim is to evaluate the effect of pretreatment video or verbal information on the stress level occurring in patients during the endodontic treatment steps by using electrodermal activity. The third aim is to investigate the relationship between patients' pretreatment anxiety levels and socio-demographic characteristics which are thought to play a role in anxiety's etiology.
15745992|NCT04892381|Diagnostic Test|Skin Biopsy|"Skin biopsy will be taken under local anesthesia :
~From each normal control; a 3 mm punch skin biopsy from a sun protected area will be taken and preserved in PBS and kept frozen at -80 degrees Celsius for ELISA study.
~From each LP patient; two punch skin biopsies will be taken and preserved in PBS and kept frozen at -80 degrees Celsius for ELISA study:
~i. The first biopsy will be a 3 mm punch biopsy from the center of LP lesional skin of sun protected area ii. The second biopsy will be a 3 mm punch biopsy from non lesional skin at least 15 cm away from the edge of any existing LP lesion of sun protected area
~The level of PD1 and PD-L1 will be detected using ELISA technique.
~The lesional biopsy will be assessed by routine hematoxylin and eosin (H&E) to confirm the diagnosis of LP"
15745993|NCT04892368|Other|Home-based supervised exercise program|Combination of aerobic and strength training exercises, in addition to home exercise instructions issued during preoperative physiotherapy education.
15745994|NCT04892355|Device|Root canal irrigation|Devices used during root canal irrigation
15745995|NCT04892342|Drug|ESG401|Administered via intravenous (IV) infusion
15745996|NCT04892329|Other|Artificial intelligence assistant system|The endoscopists in the experimental group will be assisted by EndoAngel, which can assist in identifying important anatomical structures adjacent to the pancreas in real time. The system is an non-invasive AI system .
15745997|NCT04892316|Diagnostic Test|Diagnostic test|The training dataset was used to train the model, which was validated and tested by the other two datasets.
15746052|NCT04891926|Diagnostic Test|Blood Analysis|Blood analysis in order to observ postmenopausal state, osmolalitity and sodium.
15745998|NCT04892303|Combination Product|Combination treatment (CXRPT) of external beam radiation (XRT) plus radioactive iodine (RAI)|To safely administer a minimum cumulative dose of external beam radiation to up 3 index tumors per patient, supplemented radiation dose delivered by radioactive iodine (RAI)
15745999|NCT04892290|Other|Conservative Treatment for Postdural Puncture Headache|The patients in Group C were given continuous bed rest in the supine position, 3000 mL daily hydration, 6 mg kg-1 aminophylline , 2 g day-1 paracetamol and 65 mg day-1 caffeine as conservative treatment. Topical SGB was applied to patients in Group SGB in addition to conservative treatment.
15746000|NCT04892277|Biological|Chimeric Antigen Receptor T-Cell Therapy|Given CD19/1563 IV
15746001|NCT04892277|Drug|Cyclophosphamide|Given IV
15746002|NCT04892277|Drug|Fludarabine|Given IV
15746003|NCT04892264|Biological|Belantamab Mafodotin|Given IV
15746004|NCT04892264|Biological|Daratumumab|Given IV
15746005|NCT04892264|Drug|Dexamethasone|Given PO
15746006|NCT04892264|Drug|Lenalidomide|Given PO
15746007|NCT04892251|Combination Product|MORE+KAP|Mindfulness-Oriented Recovery Enhancement plus two sessions where 0.5 to 1.5 mg/kg of ketamine are administered intramuscularly
15746008|NCT04892251|Behavioral|MORE|Mindfulness-Oriented Recovery Enhancement
15746009|NCT04892238|Diagnostic Test|13-C urea breath test|"Standard urea breath test (UBT) (HELICARB, LLC ISOCARB, reg. cert. #РЗН 2016/3773 issued by Roszdravnadzor on 29.02.2016) with 13C-carbamide of 99% purity used for the study.
~Samples of exhaled air obtained before and after 20 minutes after 50 mg 13C-urea intake are analysed for 13C/12C isotope ratio with the use of infrared spectrometer IRIS.Doc (Kibion, Sweden). Delta over baseline (δ) of 13C / 12C is calculated based on the results of the initial and second samples, the results were shown in ppm (‰). The results of the test is negative if δ was <4.0‰; test results with δ ≥4.0‰ are considered positive."
15746010|NCT04892225|Behavioral|Technology-supported behavioral intervention (text message)|A simple text message regarding the salt and fluid restriction in order to reduce the inter-dialytic weight gain will be send on daily basis to all the individuals in the intervention group.
15746011|NCT04892212|Drug|Sirolimus|The daily dose of sirolimus is divided twice.
15746012|NCT04892199|Drug|Semaglutide, 1.34 mg/mL|Semaglutide 1.34 mg/ml, 1.5 ml pre-filled pen-injector is supplied in pens for injection containing 2.0 mg of the GLP-1RA semaglutide in 1.5 ml sterile water with disodiumphosphate and propylenglycol, and phenol for conservation (pH 8.15). Direction for use will be given together with trial products.The possible doses of semaglutide are 0.25 mg, 0.50 mg and 1.0 mg. The initial weekly dose will be 0.25 mg for four weeks, then 0.5 mg for four weeks and then 1.0 mg for the remaining treatment period. Patients who, due to adverse events, do not tolerate up-titration to 1.0 mg semaglutide will remain on 0.5 mg once-weekly. The injection is administered subcutaneously once-weekly.
15746013|NCT04892199|Drug|Semaglutide-placebo|"The semaglutide placebo pens contain XX-vehicle (no active drug) and are administered in the same way and volume as semaglutide. The semaglutide placebo is specially packed for this study and will be used in the study only. The initial weekly dose will be 0.25 mg for four weeks, then 0.5 mg for four weeks and then 1.0 mg for the remaining treatment period. Patients who, due to adverse events, do not tolerate up-titration to 1.0 mg semaglutide placebo will remain on 0.5 mg once-weekly. The injection is administered once-weekly. If the lowest tolerated dose is less than 0.5 mg of semaglutide placebo once-weekly, the patient will be excluded from the study."
15746014|NCT04892186|Drug|Myo-inositol|"30 women with polycystic ovary syndrome and insulin resistance or glucose intolerance will used myo-inositol 2g twice daily for 6 months, having a re-evaluation every 3 months.
~Evaluation will be made by transvaginal ultrasound, abdominal ultrasound, inflammatory tests, hormonal tests, glycemic curve with insulin curve, lipid profile, body mass index, evaluation of abdominal and hip circumference."
15746015|NCT04892186|Drug|Metformin|"30 women with polycystic ovary syndrome and insulin resistance or glucose intolerance will used metformin three times a day for 6 months, having a re-evaluation every 3 months.
~Evaluation will be made by transvaginal ultrasound, abdominal ultrasound, inflammatory tests, hormonal tests, glycemic curve with insulin curve, lipid profile, body mass index, evaluation of abdominal and hip circumference."
15746016|NCT04892173|Drug|NBTXR3|Suspension of inert, crystalline hafnium oxide particles, designed to generate oxygen free radicals to destroy cancer cells after activation by ionizing radiation.
15746017|NCT04892173|Drug|Cetuximab|Solution for infusion
15746018|NCT04892173|Radiation|Radiation Therapy|Intensity-modulated radiation therapy (IMRT): 70 Gray in 35 fractions over a 7-week period.
15746019|NCT04892160|Other|Guided Imagery|Upon completion of study paperwork and 3-5 minutes prior to the nurse entering the room, study personnel will play an audio recording of an underwater guided imagery during one of these procedures: port access, dressing changes, and IV sticks. Guided imagery is an intervention that relies on a patient's imagination to create a sensory experience that utilizes mental images, sounds, smells, tastes, and touch. The guided imagery script used in this study describes an underwater scene and is meant to closely mimic the VR condition with the exception that it will be non-immersive. It will last approximately 15 minutes but can be played again if the procedure lasts longer than 15 minutes. Study personnel will remain in the room to record the time of the procedure, staff number, time in the room, and complete an observational measure of distress.
15746020|NCT04892160|Other|Virtual Reality|Upon completion of study paperwork and 3-5 minutes prior to the nurse entering the room, study personnel will assist the patient in beginning the VR intervention during one of these procedures: port access, dressing changes, and IV sticks. The VR intervention consists of interactive audio and visual underwater experience. The VR software offers both passive and active gameplay over the course of 15 minutes, which can be repeated. In the passive experience, the software moves patients through an ocean filled with sea creatures and allows them to look around and observe the underwater scene. In the active experience, patients launch balls at the fish. Patients will be encouraged but not required to actively participate; staff will record whether the patient participates in the active portion of the VR program. Study personnel will remain in the room to record the time of the procedure, staff number, time in the room, and complete an observational measure of distress.
15746021|NCT04892147|Behavioral|Mobility-Oriented Behavioral Activation|12-weeks of mobility-oriented behavioral activation group
15746022|NCT04892134|Other|blood sample|40-50 ml of blood is taken
15746024|NCT04892108|Procedure|STARR (Stapled Trans Anal Rectal Resection)|Patients randomly assigned to surgical intervention of STARR (Stapled Trans Anal Rectal Resection)
15746025|NCT04892108|Procedure|LVR (Laparoscopic Ventral Rectopexy)|Patients randomly assigned to surgical intervention of LVR (Laparoscopic Ventral Rectopexy)
15746026|NCT04892095|Other|No intervention|This is an observational cross-sectional study. No intervention is considered.
15746027|NCT04892082|Behavioral|Mindful Moment|The Mindful Moment program is a web-based self-guided cognitive-behavioral intervention to reduce parenting stress, targeting postpartum mothers. It consists of 6 weekly modules, each module targeting a specific thematic content, and providing mothers with both information and specific therapeutic strategies (with a strong focus on the third wave of cognitive-behavioral techniques) to address each thematic content. Modules are sequential.
15746028|NCT04892082|Other|Waiting-List Control (WLC)|The control group only receive the intervention at the end of the intervention group.
15746029|NCT04892069|Drug|Insulin Degludec/Insulin Aspart|All patients have been treated at the discretion of the treating physician in accordance with the Ryzodeg® label in Lebanon. Decision to initiate treatment with commercially available Ryzodeg® has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
15746030|NCT04892056|Other|Friction Mechanics|anterior segment retraction using elastomeric power chains
15746031|NCT04892056|Other|Frictionless Mechanics|anterior segment retraction using closing loops
15746032|NCT04892043|Biological|SQZ-AAC-HPV|activating antigen carriers (AACs) cell therapy; therapeutic vaccine engineered from red blood cells manufactured with immunogenic epitopes of HPV16
15746033|NCT04892043|Drug|Ipilimumab|cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) blocking antibody
15746034|NCT04892043|Drug|Nivolumab|programmed cell death 1 (PD-1) blocking antibody
15746035|NCT04892030|Behavioral|Whole Food Plant-Based Behavioral Weight Loss Treatment|Over the course of 12-weeks, participants will be prescribed a non-energy-restricted whole food plant-based diet and will learn behavioral weight loss strategies through an e-learning platform. Each week, participants will also complete a 15-minute coaching call to provide positive reinforcement and problem-solving support.
15746036|NCT04892017|Drug|DCC-3116|Oral Tablet Formulation
15746037|NCT04892017|Drug|Trametinib|Oral Tablet Formulation
15746038|NCT04892004|Behavioral|Symptom recognition|The patient receives a leaflet, which includes information about HF, primary symptoms, awareness of its detection and the fluid management plan. It also receives a weight diary, which helps him/her recall weight fluctuation and contact the nurse or doctor to call for help in a previous stage and avoid hospitalisation. Patients have to explain what they understand by HF, on follow-ups contacts, which are the main symptoms, if they are experiencing any of them and which difficulties managing fluid restriction and weight control. The leading investigator validates the information and teaches back contents if required.
15746039|NCT04891991|Drug|Intravitreal infliximab|1 mg/0.05 mL of infliximab will be injected intravitreally at the end of pars plana vitrectomy.
15746040|NCT04891991|Procedure|Pars plana vitrectomy|Standard pars plana vitrectomy
15746044|NCT04891965|Biological|ART24|Each ART24 capsule will contain lyophilized ART24 and inactive excipients. ART24 will be supplied in a dose strength of 5×10^9 CFU/capsule. Subjects will receive 1 capsule daily.
15746045|NCT04891965|Drug|Placebo|Each placebo capsule is identical in appearance, weight, and packaging to ART24 capsules, but will contain only the inactive excipients. Subjects will receive 1 capsule daily.
15746046|NCT04891952|Diagnostic Test|Onco4D Biodynamic Chemotherapy Selection Assay|Functional precision medicine test to predict response to candidate chemotherapeutic agents
15746047|NCT04891939|Other|Health education lessons (Smart-Kid's program)|The intervention is designed for all students, including never-smokers and students at high risk for smoking. Therefore, some contents are intended to influence those high-risk youth within the larger student audience by targeting the stages of the smoking acquisition process including, preparation, initiation, experimentation, regular use, and addiction (Mayhew et al., 2000). The intervention is also focused on addressing risk factors for smoking initiation and continue use (Hansen et al., 2015; So & Yeo, 2015). These risk factors are, therefore, grouped into four major groups namely; personal factors, behavioral factors, environmental factors and sociodemographic factors
15746048|NCT04891939|Other|School Health and Education Program (SHEP)|The SHEP is the usual health and education program been done in all schools, and also has tobacco control component. This is will be used as the control for the intervention.
15746049|NCT04891926|Diagnostic Test|ICIQ FLUTS Questionaires|Questionnaire observing the impact on voiding disfunctions
15746050|NCT04891926|Diagnostic Test|Frequency Volume Chart|Frequency Volume Chart measures the voided volumes and fluid intake during 3 days in order to observe patients bladder capacity, total and nighttime voided volume and voiding frequency
15746051|NCT04891926|Diagnostic Test|Renal Function Profile|The RFP is a 24-hour urine analysis in which urine samples are collected at fixed time points every 3 hours, starting 3 hours after the first morning void. This RFP was collected on a separated day to the FVC. Daytime samples were taken between 10:00-11:30 (U1), 13:00-15:30 (U2), 16:00-17:30 (U3), 19:00-20:30 (U4), and 22:00-23:30 (U5). The night-time samples were taken between 1:00-2:30 (U6), 4:00-5:30 (U7) and 7:00-8:30 (U8), and the volume of each interim void, was noted to calculate the 24h, daytime and night-time urine volume and diuresis rate. On each of this 8 samples, creatinine, osmolality, sodium and urea concentration were analysed. Subsequently, the renal clearance of creatinine, solutes, sodium and potassium (Usubst x Uflow / Psubst) and FWC (urine flow - solute clearance) were calculated.
15779738|NCT04615884|Other|Placebo capsules|Placebo
15746053|NCT04891913|Drug|SY-007/ Placebo 15mg|15 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days.
15746054|NCT04891913|Drug|SY-007/ Placebo 30mg|30 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days.
15746055|NCT04891913|Drug|SY-007/ Placebo 60mg|60 mg SY-007/ Placebo, the dosing interval is 12 hours ±2 hours for 7 consecutive days.
15746056|NCT04891900|Drug|TQB2450/Anlotinib hydrochloride/Oxaliplatin/Capecitabine|"Initial treatment (6 cycles)：
~TQB2450：1200 mg , Day 1 ivgtt ,once every 3 weeks
~Anlotinib: 10 mg/day orally ，from days 1 to 14 in a 21-day cycle
~Oxaliplatin: 130 mg / m2, Day 1 ivgtt ,once every 3 weeks
~Capecitabine: 1000 mg / m2, orally, twice a day (once in the morning and once in the evening), from days 1 to 14 in a 21-day cycle Maintenance treatment：
~1）TQB2450: 1200 mg , Day 1 ivgtt , once every 3 weeks 2）Anlotinib: 10 mg/day orally , from days 1 to 14 in a 21-day cycle"
15746057|NCT04891887|Behavioral|Health education program|"Seven face to face sessions and group discussion health education sessions. Two prepared booklets were distributed to all attendants titled Diabetes mellitus and how to control its complications and Mild cognitive impairment and how to prevent it.
~Lab results were discussed individually with each participant to discuss his adherence to the lifestyle modification program.
~Clinical follow-up and management with endocrinology and neurology specialists. Individualized Medical Nutrition. Participants were then counselled on healthy eating habits.
~Individualized biweekly follow-up scheme through mobile phone. A WhatsApp group was created for all participants to contact the research team whenever they have any inquiry concerning life style modifications. Through this group, 12 HE audio electronic messages were shared with participants.
~Final reassessment of clinical status and laboratory profile was carried out with participants who continued till the end of the study."
15746058|NCT04891874|Radiation|Stereotactic radiotherapy|Radiation using stereotactic radiotherapy device.
15746059|NCT04891861|Drug|Apixaban|Direct Oral Anticoagulation all at label dose and frequency
15746060|NCT04891848|Other|inflammation|inflammatory values in complete blood count (CBC)
15746061|NCT04891835|Other|Data extraction from medical files|Data extraction from medical files
15746062|NCT04891822|Procedure|ERAS protocol|E: ERAS protocol C: control
15746063|NCT04891809|Drug|Isatuximab-Irfc 20 MG/ML [Sarclisa]|Induction: 10mg/kg on day 1,8,15,22 in cycle 1, subsequently on day 1, 15; every 28 days (q28 days) Maintenance: 10mg/kg, day1, q28 days until progression or intolerance but for a maximum of 24 cycles from start of maintenance
15746064|NCT04891809|Drug|Lenalidomide|"Induction: 25mg*, day 1-21, every 28 days (q28 days); Maintenance: 5-10mg, day 1-21, q28 days (according to individual tolerance) until progression or intolerance but for a maximum of 24 cycles from start of maintenance
~*) for patients with moderate renal impairment (30≤ GFR (MDRD formula) < 50 mL/min) starting dose is 10 mg"
15746065|NCT04891809|Drug|Dexamethasone Oral|"Induction:
~Patients aged <75 years: 40mg, once weekly; Patients aged ≥75 years: 20mg, once weekly"
15746066|NCT04891796|Other|No intervention|No intervention
15746067|NCT04891783|Device|ultrasonography|The Carotid US examination will be performed by a radiologist, according to the same protocol in the different participating hospitals. It will include the measurement of cIMT in the common carotid artery and the detection of focal plaques in the extracranial carotid tree following the Mannheimconsensus[26]. Plaque is defined as a focal protrusion in the lumen at least cIMT>1.5 mm, protrusion at least 50% greater than the surrounding cIMT, or arterial lumen encroaching >0.5 mm [26]. The cIMT will be determined as the average of three measurements in each common carotid artery. The final cIMT is the largest average cIMT (left or right). Patients with carotid plaques will be considered as having very high CV .
15746073|NCT04891744|Drug|Selinexor|Selinexor (ATG-010# is a first-in-class, oral selective exportin 1 (XPO1) inhibitor (1,2). Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus along with inhibition of translation of oncoprotein mRNAs.
15746074|NCT04891744|Drug|Thalidomide|100mg/d, Po. on day1-28
15746075|NCT04891744|Drug|Dexamethasone|20 mg/d Po. on day 1, 2,8,9,15,16,22,23
15746076|NCT04891731|Drug|AI or TAM|This is an observational study, the researcher will describe the ratio of E2 control between leuprorelin plus TAM or leuprorelin plus AIs patients based on the actual clinical use.
15746077|NCT04891718|Biological|MVC-101|Intratumoural microdose injection by the CIVO device.
15746078|NCT04891718|Biological|Nivolumab|Intratumoural microdose injection by the CIVO device.
15746079|NCT04891718|Combination Product|MVC-101 + Nivolumab|Intratumoural microdose injection by the CIVO device.
15746080|NCT04891705|Device|Lung Ultrasound Scan|Ultrasound scan of subjects in up to 14 lung zones
15746081|NCT04891692|Device|StimaWell 120MTRS system|Medium-frequency electrotherapy device that delivers current via up to 12 channels. The device also provides heat therapy up to 40°C.
15746082|NCT04891679|Drug|Oral misoprostol solution (OMS)|"Based on the WHO labor induction recommendation, and for the purpose of achieving precise oral misoprostol dosage, one misoprostol tablet (200 mcg) was pulverized and dissolved into 200 ml water.90 Thus 1ml of solution had 1mcg of misoprostol. This misoprostol solution could be preserved at room temperature and remained active for 24 hours.
~Hourly titrated oral misoprostol solution was given to group A as described by Wang X et al, 2016 as described below.
~0 hour= 20ml
~hour= 20ml
~hour= 30ml
~hour= 30ml
~hour= 30ml
~hour= 40ml 6.5 hour= 50ml 8.5 hour= 60ml 10.5 hour=60ml
~Group B received 25 mcg (25 ml) oral misoprostol solution every 2 hours for a maximum of 12 doses or until the onset of regular uterine activity."
15746083|NCT04891666|Dietary Supplement|Lactobacillus plantarum DSM 33464|1 sachet SmartGuard® per day for 24 weeks
15746084|NCT04891653|Drug|BR790|Subjects will receive oral administration of BR790.
15746085|NCT04891640|Other|Standard TNFi Therapy|Participants randomly assigned to this arm will continue taking their TNFi medication as currently prescribed.
15746119|NCT04891406|Other|Skruf|Use of product C (Skruf snus fresh slim white, 10.9 mg nicotine/pouch) for 20 minutes
15779854|NCT04614961|Other|Medical therapy|Medical therapy
15746086|NCT04891640|Other|TNFi fixed longer dosing intervals|"Participants randomly assigned to this arm will increase the time between TNFi medication doses.
~Adalimumab- from every 2 to 3 weeks
~Certolizumab- from every 2 to 4 weeks
~Etanercept- from every 1 to 2 weeks
~Golimumab- from every 4 to 6 weeks
~Infliximab- from baseline to baseline + 2 weeks"
15746087|NCT04891640|Other|Stop TNFi treatment|Participants randomly assigned to this arm will stop TNFi medication.
15746088|NCT04891627|Diagnostic Test|Gingival crevicular fluid|GCF samples were collected in the morning hours 24-48 hours after clinical periodontal measurement.
15746089|NCT04891614|Device|PRISM|Subjects will complete 15 neurofeedback training sessions delivered twice per week, on non-consecutive days, over 8 consecutive weeks.
15746090|NCT04891601|Procedure|polypropelene mesh|compare use mesh alone or combined mesh and darn repair
15746091|NCT04891588|Drug|Switching the preserved prostaglandin analog-timolol FC to Fixalpost (preservative free prostaglandin analog-timolol FC)|"switching preserved prostaglandin analog- timolol FC (fixed combination) in the period of three months in patients with ocular hypertension and open angle glaucoma who exhibit ocular surface disease (OSD) signs and symptoms to an equally effective and safe preservative - free (PF) latanoprost - timolol FC (Fixalpost).
~form: preservative free latanoprost - timolol fix combination (50 micrograms/ml latanoprost + 5 mg/ml timolol), ocular solution dosage: once daily, at 8.00 p.m. duration: 3 months"
15746092|NCT04891575|Behavioral|Active Control Intervention educational sessions|The participant will attend 8 sessions that provide type 2 diabetes (T2D) and cardiovascular (CVD) risk reduction and lifestyle modification education focused on CVD and T2D risk factor reduction through promotion of participant self-management. Education will concentrate on healthy eating, physical activity, stress reduction, and other lifestyle risk reduction recommendations.
15746093|NCT04891575|Behavioral|Family Dyad Intervention|The participant and a co-participating family member will attend 8 sessions that provide type 2 diabetes (T2D) and cardiovascular (CVD) risk reduction and lifestyle modification education focused on CVD and T2D risk factor reduction through promotion of participant self-management. Education will concentrate on healthy eating, physical activity, stress reduction, and other lifestyle risk reduction recommendations.
15746094|NCT04891562|Other|interlimb coordination of the lower limbs and synchronization|4 sessions (2 descriptive sessions, 2 experimental sessions), each lasting around 60 minutes. The m-ABC2 test, The MBEMA-s, Kids BESTest, interlimb coordination and synchronization investigation (visit 3 and 4)
15746095|NCT04891549|Procedure|Tension band fixation|Fracture fixation of the patella fracture with tension band.
15746096|NCT04891549|Procedure|Plate fixation|Fracture fixation of the patella fracture with a plate.
15746097|NCT04891536|Procedure|Salvage cryoablation of the prostate (SCAP)|Cryotherapy of the prostate through transperineal freeezing needles
15746098|NCT04891523|Dietary Supplement|Probiotics-O (Burgerstein)|Topical oral treatment with the probiotic Streptococcus salivarius K12 (BIOTICS-O, Burgerstein) in form of a lozenge, daily, during 3 weeks.
15746099|NCT04891523|Other|Placebo [inactivated Probiotics-O (Burgerstein)]|Topical oral treatment with the placebo [inactivated probiotic Streptococcus salivarius K12 (BIOTICS-O, Burgerstein)] in form of a lozenge, daily, during 3 weeks.
15746100|NCT04891510|Device|REVOLVE Advanced Adipose System|The REVOLVE system is an all-in-one fat processing device that harvests, filters, actively washes, and removes strands from lipoaspirate and allows for reinjection without any additional manipulation (REVOLVE 2020).
15746101|NCT04891510|Device|LipoGrafter|The LipoGrafter system is designed to be a start-to-finish closed system with minimal processing of the lipoaspirate, minimizing the risk of contamination and fat cell damage (LipoGrafter 2020).
15746102|NCT04891510|Procedure|Standard Decantation technique|Traditional standard decantation technique for breast reconstruction.
15746103|NCT04891497|Drug|Dimethyl Fumarate|Dimethyl fumarate 240mg orally twice daily for 3 consecutive days
15746104|NCT04891497|Drug|Placebo|Placebo 240mg orally twice daily for 3 consecutive days
15746105|NCT04891484|Drug|Ondansetron group|patients will be injected with 4 mg Ondansetron diluted with normal saline IV 5 minutes before spinal anesthesia
15746106|NCT04891484|Drug|Saline group|patients will be injected with 10 ml normal saline intravenous 5 min before spinal anesthesia
15746107|NCT04891471|Radiation|Stereotactic RadioTherapy|To treat only brain metastasis identified through Magnetic Resonance imaging by means of stereotactic radiotherapy (experimental intervention) to determine if sparing of clinically uninvolved brain implies a better neurocognitive performance, quality of life and level of autonomy in activities of daily living respect to Whole Brain Irradiation (active comparator).
15746108|NCT04891471|Radiation|Whole Brain Irradiation|To irradiate the entire brain, site of at least 5 parenchymal metastasis.
15746109|NCT04891458|Drug|Patients received lighter sedation with propofol after spinal anesthesia.|MOAA/S 0-2.
15746110|NCT04891458|Drug|Patients received heavier sedation with propofol after spinal anesthesia|MOAA/S 3-5.
15746111|NCT04891458|Drug|Patients received lighter sedation with dexmedetomidine after spinal anesthesia|MOAA/S 0-2.
15746112|NCT04891458|Drug|Patients received heavier sedation with dexmedetomidine after spinal anesthesia.|MOAA/S 3-5.
15746113|NCT04891445|Behavioral|Nursing monitoring program|A clinical pathway will be activate that allows all the necessary interventions, once the person is diagnosed, to be carried out on the same day, and a mental health nursing team will monitor the entire process.
15746114|NCT04891445|Behavioral|As usual|Referral to the family doctor for a request for follow-up by the gastroenterologist. The specialist prescribes the tests for the definitive diagnosis that will take place in other units (with their corresponding appointments). After this, the patient will return to the specialist to establish the treatment to follow. Pharmacological treatment will be dispensed at the hospital pharmacy (collected once a month until completion of treatment and confirmation of cure). This last step of the treatment will be done in a new consultation at the gastroenterology service after blood tests to verify the disappearance of the viral load.
15746115|NCT04891432|Procedure|Lateral lumbar interbody fusion|oblique lumbar interbody fusion or direct lateral interbody fusion
15746116|NCT04891419|Device|JUVÉDERM® VOLUMA® with Lidocaine|JUVÉDERM® VOLUMA® with Lidocaine injectable gel
15746117|NCT04891406|Other|ZoneX#2|Use of product A (ZoneX #2, white tobacco-free nicotine pouch, 5.8 mg nicotine/pouch) for 20 minutes
15746118|NCT04891406|Other|ZoneX#3|Use of product B (ZoneX #3, white tobacco-free nicotine pouch, 10.1 mg nicotine/pouch) for 20 minutes
15746120|NCT04891406|Other|Swave|Use of product D (Swave Daquiri, nicotine pouch, 10.6 mg/pouch) for 20 minutes
15746121|NCT04891406|Other|Marlboro Gold|Use of product E (Marlboro Gold, conventional cigarette, 0.8 mg nicotine/cigarette) for approximately 5 minutes
15746122|NCT04891393|Dietary Supplement|Coffee|"Starbucks brand Via instant coffee. (Caffeine Content: 3 mg / kg)"
15746123|NCT04891393|Dietary Supplement|Decaffeinated coffee|"Starbucks brand Via instant decaffeinated coffee. (Caffeine Content: 15 - 25 mg)"
15746124|NCT04891380|Device|LUCAS 2 Active Decompression 2|Chest compression with active decompression of the chest. Measurement of physiological parameters.
15746125|NCT04891380|Other|Hypotension|measurement of physiological parameters
15746126|NCT04891380|Other|Intensive care transport|Measurement of physiological parameters
15746127|NCT04891367|Other|Cognitive behavioral therapy|The G-CBT manual for adolescents has been developed in the OCD-clinic in Aarhus and pilot tested in Aarhus. The G-CBT manual is based on the NordLOTS I-CBT manual in overall content and structure, with a few additional elements added with inspiration from previous individual and group CBT literature as well as the author's ideas. The main therapeutic ingredient is exposure and response prevention. The manual is made up of three individual family sessions, 13 weekly adolescent group sessions, three parent group sessions and two adolescent group booster sessions.The manual contains detailed guiding of therapists for each session and a comprehensive collection of working sheets for the adolescents to be used during sessions.
15746128|NCT04891354|Drug|PDNO|PDNO is the experimental drug
15746129|NCT04891354|Drug|Sodium chloride|Sodium chloride is just as placebo
15746130|NCT04891341|Other|Technology Supported Task-Oriented Circuit Training|"Ten workstations, which are frequently used in the literature and determined according to the clinical experience of the research team, have been created. Each workstation will be applied for a total of 1 hour, in the form of 5 minutes of training and 1 minute of rest.
~Sit to stand
~Standing and trunk training
~Standing and lower limb training
~Stepping
~Walking
~Walking with object manipulation
~Climbing and descending stairs
~Unilateral upper extremity activity training (VR)
~Bilateral upper extremity activity training (VR)
~Upper extremity reaction time training (VR) Virtual reality games will be played using the USE-IT intelligent physiotherapy game system. The system offers unilateral, bilateral and bimanual upper extremity training to individuals with a 55 inch touch screen and 7 computer games (balloon popping, car washing, plumbing, arithmetic, apartment, drum and matching)."
15746131|NCT04891341|Other|Home-based Telerehabilitation|Strengthening, balance and coordination exercises will be sent to the participants via a mobile application. Patients will do the exercises at home and send a notification to their physiotherapist. Intervention will be applied for 1 hour, 3 days a week for 8 weeks.
15746132|NCT04891328|Other|Intensive therapy program|The intensive therapy program consists of physical therapy, occupational therapy, and speech therapy 3-6 hours x 4-5 days/week for 4 weeks. The individual therapies received will vary with the child/caregiver goals and be based on neuroplasticity and motor learning principles.
15746133|NCT04891315|Diagnostic Test|Blood test for soluble VAP-1 (sVAP-1).|~5ml blood will be taken and sVAP-1 will be measure by Enzyme linked Immunosorbent Assay
15746134|NCT04891302|Drug|Clevudine|Clevudine 150mg (5 capsules) once a day will be administered orally and can be taken regardless of food intake for 10 days
15746135|NCT04891302|Drug|Placebo|Matching Placebo (5 capsules) once a day will be administered orally and can be taken regardless of food intake for 10 days
15746136|NCT04891289|Drug|Gemcitabine|See arm for details.
15746137|NCT04891289|Drug|Oxaliplatin|See arm for details.
15746138|NCT04891289|Drug|Dexamethasone|See arm for details.
15746139|NCT04891289|Drug|Floxuridine (FUDR)|See arm for details.
15746140|NCT04891289|Device|Implanted Medical Device|Implanted hepatic arterial infusion pump by surgical oncology, to deliver HAI therapy
15746141|NCT04891276|Other|Data collection|Data collection on the national PMSI database
15746142|NCT04891263|Procedure|Suture-Septoplasty|Patients receive suture-septoplasty for repair of nasal septal deviation.
15746143|NCT04891263|Device|Surgical suture|Suture used for closure during septoplasty surgery.
15746144|NCT04891250|Drug|Ivermectin|Treatment of SARS Cov-2 patients with Ivermectin
15746145|NCT04891250|Other|Prophylaxis|Treatment of high risk population with Ivermectin as prophylaxis
15746146|NCT04891237|Biological|10,000 MG01 + 10,000 T517|Purified and polymerized with glutaraldehyde allergen extract, from a mixture of grasses (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca pratensis, Lolium perenne and Dactylis glomerata) and Olea (Olea europaea), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections
15746147|NCT04891237|Biological|30,000 MG01 + 10,000 T517|Purified and polymerized with glutaraldehyde allergen extract, from a mixture of grasses (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca pratensis, Lolium perenne and Dactylis glomerata) and Olea (Olea europaea), adsorbed on aluminum hydroxide. The other ingredients are: sodium chloride (0.9%), phenol (0.4%) and water for injections
15746148|NCT04891237|Other|Placebo|The same solution and presentation as the active treatment, but without active ingredients
15746149|NCT04891224|Other|Pathway Platform mobile app|The pathway platform intervention involves 3 components: 1. The patient facing app which will: a) Gather health information related to depression management and patient-Provider engagement. b) Clinical data collection; PHQ-9, WHO-5, PDQ-D-5, medication adherence and side effects, goal setting and goal tracking. c) Research data; Patient Activation Measure -13[PAM-13], CollaboRATE, and Work and Social Adjustment Scale [WSAS]. 2. Electronic Medical Record Integration - a) Data collected in the app is accessible to care team in real time. b) Provide a longitudinal summary to assist in decision making and depression management. 3. Educational Scaffolding - a) Training program describing how the Pathway Platform can support care team members in clinical processes related to measurement-based care and shared-decision making. b) Includes ongoing feedback with up to three audit cycles.
15746150|NCT04891211|Dietary Supplement|Vitamin D deficiency|Ocular significance of vitamin D deficiency in pediatric cases
15746151|NCT04891198|Drug|Envafolimab|Subcutaneous injection
15746152|NCT04891185|Drug|Indocyanine green|Administration of the IMP: Indocyanine green, 0,25mg/kg of body weight, intravenous bolus injection
15746423|NCT04888975|Device|Dayspring Active Wearable Compression System|Dayspring Active Wearable Compression System
15746424|NCT04888962|Other|OUD|History of opioid use disorder.
15746153|NCT04891172|Biological|Anti COVID 19 Intravenous Immunoglobulin (C-IVIG)|"Intervention arm will receive single dose of 0.15g/kg C-IVIG. This will be infused within period of 16 hours intravenously. Additionally, all participants will receive same standard care.
~Standard Care as per hospital protocol, which may include:
~Airway support, Anti-Viral medication, Antibiotics, Fluid Resuscitation, Hemodynamic Support, Steroids, Painkillers, Anti-Pyretics, anti coagulant"
15746154|NCT04891159|Other|Shared decision making|The intervention consists of 5 components: 1) Online shared decision making training (2 hours, e-learning); 2) Individual coaching for doctors by a shared decision making expert; 3) Implementation of the shared decision making; 4) Link to institutional approaches to patient engagement; 5) Integration of the shared decision making into the multidisciplinary consultation meetings of the Cystic Fibrosis Centers Competences.
15746155|NCT04891146|Other|Systemic inflammatory immmune index|Systemic Inflammatory Immune index calculated from platelet, neutrophil and lymphocyte count
15746156|NCT04891133|Drug|Baricitinib|4 mg baricitinib (2 tablets of 2 mg) once daily
15746157|NCT04891133|Drug|Placebo|4 mg placebo (2 tablets of 2 mg) once daily
15746158|NCT04891120|Diagnostic Test|Treadmill test (Bruce protocol)|Treadmill test performed with and without a mask.
15746159|NCT04891107|Device|Walking Program with a Music-based, Rhythm-modulating Wearable Sensor System|Participants will walk using the music-based, rhythm-modulating wearable sensor system (foot sensors, mobile device with mobile app and headphones) for thirty (30) minutes at a time, 5 times a week for 4 weeks.
15746160|NCT04891094|Diagnostic Test|Ultrasound|daily ultrasound of the lung and the diaphragm
15746161|NCT04891068|Drug|Azacitidine|5-Azacitidine is a pyrimidine nucleoside analog in which nitrogen replaces carbon at position 5
15746162|NCT04891029|Diagnostic Test|DOvEEgene test|Women participating in the study will undergo a genomic uterine pap test, DOvEEgene test, for the screening of ovarian and endometrial cancers
15746163|NCT04891016|Drug|delayed toripalimab|chemotherapy plus toripalimab and toripalimab was delayed on day 3
15746164|NCT04891016|Drug|control|chemotherapy and toripalimab were given on same day
15746165|NCT04891003|Diagnostic Test|Ultrasonography|The identification of optimal ultrasonografic tecniques for determining the location , size and the surgical methods of intestinal endometriotric nodules.
15746166|NCT04890990|Behavioral|Short videos|Intervention videos will each be of 90-second duration and feature two underage professionals (ages 16) acting as a simulated patient. All videos will focus on an empowered presenter with depression sharing her personal story regarding depression and describe how social supports from family, friends, and community, as well as professional help assisted her in overcoming symptoms of the illness. The actors will include a Black girl and a white girl.
15746167|NCT04890977|Behavioral|Talking Story|A culturally grounded modular intervention to increase mental health treatment-seeking among Pacific Islanders.
15746168|NCT04890964|Device|Transcranial Direct Current Stimulation (tDCS)|A stimulation device, that releases 2.0mA current by a 35 cm2 electrode direct located on a specific location on the scalp for 20 minutes
15746169|NCT04890951|Procedure|Hysteropexy|Uterine preservation through suspension
15746170|NCT04890951|Procedure|Hysterectomy and vaginal vault suspension|Uterine removal and sewing the vagina upwards
15746171|NCT04890938|Combination Product|Sputum-guided management and comprehensive care management|Those in the intervention group will have their treatment determined by the presence and type of airway inflammation whether during AECOPD or as part of clinic optimization. Corticosteroids are given for airway eosinophilia (sputum eosinophils >3%), and antibiotics for airway neutrophilia (sputum neutrophils ≥65% and total cells >10 million cells/gram) or a positive sputum culture. Specialized stains to identify aspiration (Oil Red O; (3)) and left ventricular dysfunction (Perl's Prussian blue; (4)) will guide swallowing assessment and cardiac work-up, respectively. If a sputum sample is not produced as an outpatient spontaneously, then sputum induction will be pursued 8 weeks after discharge. If there are no sputum samples to guide inhaler regimen, then it will be determined by the study physician guided by the Canadian Thoracic Society guidelines (2) if a sputum-guided regimen has not already been established.
15746172|NCT04890938|Other|Standard of Care|As per previous, this group will receive three follow-up visits with study pulmonologist and clinic personnel interventions.
15746173|NCT04890925|Behavioral|Community Support Network (CSN) intervention|The SOAR Community Support Network (CSN) intervention is a multi-pillar, interdisciplinary system platform focused on improving higher order cognitive functions through aerobic exercise, mindfulness meditation, counselling, quality of life tracking, and cognitive exercises. The goal is to improve cognitive functions such as executive function, reasoning, and memory among those experiencing the effects of brain injury. Individually tailored protocol is administered to each participant. Goals are set daily, weekly, and monthly, and accomplishments tracked in a database. The CSN seeks to test and evaluate the success of the program when applied, and tailored, to survivors of brain injury in intimate partner violence.
15746174|NCT04890925|Behavioral|Usual care|Participants in this group will receive dose-equivalent usual care based on the findings of a recent survey of the Canadian Rehabilitation Clinicians for concussion management, scoping review and clinical studies. Based on the evidence, usual care in this study will consist of education and aerobic exercises. Education includes information about the injury, recovery, management, nutrition, hydration, sleep, reassurance and goal setting that will be adapted to make appropriate to the population of this study. Aerobics include stationary cycling and treadmill exercises.
15746247|NCT04890457|Device|Sham stimulation via earlobe|The device will send stimulus intensity around 0.5mA via earlobe in the left ear (based on participants' subjective report), delivered with a pulse width of 0.25 ms at 25 Hz. Stimulation will be active for 30 seconds, followed by a break of 30 seconds.
15746248|NCT04890431|Drug|Oxygen|oxygen treatment (5 L/minute for 30 minutes by nasal cannula, twice/day)
15746249|NCT04890431|Drug|Placebo|ambient air not enriched with oxygen (5 L/minute for 30 minutes by nasal cannula, twice/day)
15747157|NCT04882813|Drug|Sitagliptin|Sitagliptin dispensing claim is used as the reference group.
15746177|NCT04890899|Procedure|Cystic enculation of spleen hydatid|Preoperative preparation did according to the general condition of the patient and fitness for anaesthesia. Laparotomy did under general anaesthesia, supine position, the abdomen opened either by midline or left subcostal incision. Identification of splenic hydatid cyst. Exploration of the peritoneal cavity for undetected hepatic or peritoneal hydatid preoperatively. Isolation of operative field by packs socked with hypertonic solution (20 -30 % hypertonic saline). Aspiration of the cyst fluid. Injection of suitable amount about 5 ml of (1 % of cetramid) solution and waiting for at least 5 minutes and then re-aspiration. The spleen is not needed to mobilize. Extraction of the endocyst and washing of the cavity with normal saline. Occupying the cystic cavity intracystic drain. Perioperative and postoperative close observation of the patient for an anaphylactic reaction or any other complication. Follow-up of the patient until discharge from hospital on (3th - 5th) days.
15746178|NCT04890886|Diagnostic Test|Thermal imaging|Use of a thermal imaging cameral to measure brown and white adipose tissue function
15746179|NCT04890886|Diagnostic Test|Echocardiogram|Echocardiographic imaging of the fetal heart to assess ventricular function
15746180|NCT04890886|Diagnostic Test|ECG|ECG of the fetus and the neonate to look at the cardiac electrical activity
15746181|NCT04890886|Diagnostic Test|MRI scan|MRI scan of the neonate to assess adipose tissue, liver architecture and cardiac structure and function
15746182|NCT04890886|Diagnostic Test|Serum blood markers|Serum sample taken from mother before birth and umbilical cord or neonatal blood spot at birth to assess glucose levels / lipid levels and lipidomics and cardiac function (using NTproBNP) as a marker
15746183|NCT04890873|Drug|ERX1000|ERX1000 powder provided for preparation of a 4 mg/10 mL oral suspension
15746184|NCT04890873|Drug|Placebo|A suspension containing magnesium hydroxide carbonate in polysorbate
15746185|NCT04890860|Other|cardiac surgery involving mitral or tricuspid valve repair procedure, with cardiopulmonary bypass|cardiac surgery involving mitral or tricuspid valve repair procedure, with cardiopulmonary bypass
15746186|NCT04890834|Other|Best Practice|Receive standard care
15746187|NCT04890834|Other|Exercise Intervention|Participate in yoga sessions
15746188|NCT04890834|Other|Questionnaire Administration|Ancillary studies
15746189|NCT04890821|Device|CI Percutaneous Ring Annuloplasty System|Percutaneous transcatheter implant and adjustment of the CI ring annuloplasty system.
15746190|NCT04890808|Dietary Supplement|Inosine|Patients will be dosed with two 500 mg capsules of Inosine twice daily for 36 months
15746191|NCT04890808|Dietary Supplement|IP6|Patients will be dosed with two 500 mg capsules of IP6 twice daily for 36 months
15746192|NCT04890795|Drug|AL8326 tablets|10mg/tablet;Oral administration, once daily.
15746193|NCT04890769|Device|Moisture sensor wound dressing|Clinical procedure for change of wound dressing
15746194|NCT04890756|Other|observational|"The reliability was determined (n=100) by filling out the mBQ, two times, one week apart (test-retest).
~For validation (n=45), the scores between the modified Baecke Questionnaire and the International Physical Activity Questionnaire were compared and the correlation between the modified Baecke Questionnaire and VO2max(via Astrand-Rhyming Cycle Ergometer Test) and between mBQ and interview (via METS) were assessed."
15746195|NCT04890743|Other|Kinesiotherapy combined with electrotherapy (Convenctional TENS method).|One of the four groups created during randomization will undergo a unified program of kinesiotherapy and electrotherapy (Conventional TENS method).
15746196|NCT04890743|Other|Kinesiotherapy combined with electrotherapy (Pseudo-acupuncture TENS method).|One of the four groups created during randomization will undergo a unified program of kinesiotherapy and electrotherapy (Pseudo-acupuncture TENS method).
15746197|NCT04890743|Other|Kinesiotherapy combined with electrotherapy (Trabert ultrastimulation method)|One of the four groups created during randomization will undergo a unified program of kinesiotherapy and electrotherapy (Trabert ultrastimulation method).
15746198|NCT04890743|Other|Kinesiotherapy combined with placebo electrotherapy|One of the four groups created during randomization will undergo a unified program of kinesiotherapy and placebo electrotherapy.
15746199|NCT04890730|Other|Esophagogastroduodenoscopies|Each enrolled patient needs to undergo Esophagogastroduodenoscopies and elastography
15746200|NCT04890704|Drug|Curcuminoid|Patients were stratified according to baseline eGFR and diabetes status with 1:1 assignment into curcuminoids and placebo group. Curcuminoids (250 mg capsules) were purchased from the Government Pharmaceutical Organization of Thailand (Anti-ox® registration number 1A 1/60(H)), which contained curcumin: demethoxycurcumin: bis-demothoxycurcumin at the ratio of 1:0.5:0.2.
15746201|NCT04890704|Drug|Placebo|Identical capsules were used for the placebo from the same manufacturer.
15746202|NCT04890691|Device|Feel Bright Light|During the first waking hour, the participants will be required to wear the light visor (either therapeutic or placebo light) for 30 minutes/day for 4 weeks.
15746203|NCT04890678|Device|22 residentsat risk for PU development|"mattress in bed
~The presence of PUs will be evaluated using the European Pressure Ulcer Advisory Panel (EPUAP) classification system (NPUAP, 2014) and the presence of incontinence- associated dermatitis (IAD) will be categorized using the Ghent Global IAD Categorisation Tool (GLOBIAD). For each participant, the Patient Repositioning Tool Ghent (PROTECT) will be used to individually recommend the frequency of skin observations and the frequency of repositioning."
15746204|NCT04890678|Device|18 residents at least one PU category III-IV in the sacral area|"mattress in bed The presence of PUs will be evaluated using the European Pressure Ulcer Advisory Panel (EPUAP) classification system (NPUAP, 2014) and the presence of incontinence- associated dermatitis (IAD) will be categorized using the Ghent Global IAD Categorisation Tool (GLOBIAD). For each participant, the Patient Repositioning Tool Ghent (PROTECT) will be used to individually recommend the frequency of skin observations and the frequency of repositioning.
~In the group of participants with a PU category III or IV, the Pressure Ulcer Scale for Healing Tool (PUSH) will be used to assess and measure change in PU status. The score on the PUSH-tool is defined by the surface area of the PU (length x width), the amount of exudate and the type of tissue in the wound bed."
15746250|NCT04890418|Drug|Ketalar, 5 mg/mL Injectable Solution|The patients will receive (slow intravenous injection) 0.3 mg/kg intravenous ketamine diluted by the pharmacy department into 10mL saline after the realization of PNB but before tourniquet set up and before start of surgery.
15746251|NCT04890418|Other|Placebo|The patients will receive 10 mL of 0.9% saline. This injection is also performed after the realization of PNB but before tourniquet set up and before start of surgery.
15746205|NCT04890665|Behavioral|Online psychological intervention for healthcare workers|"The intervention is based on Cognitive Behavioral Therapy, Mindfulness, Behavioral Activation Therapy, Acceptance and Commitment Therapy and Positive Psychology, aimed at the Psychoeducation regarding the manifestations of anxiety, depression, burnout, fatigue compassion, posttraumatic stress disorder, and affectations in sleep quality and perception of life quality in healthcare workers.
~And 3 complementary modules that according to the scientific literature could affect the mental health of healthcare workers related to how to deliver bad health news, Psychological first aid and how beliefs could influence physical and emotional self-care in the face of the COVID-19 pandemic."
15746206|NCT04890652|Behavioral|4-week intervention|All participants will receive a digital intervention to reduce drinking for 4 weeks. There will be two therapy sessions each week using alcohol treatment combined with breathing-based stress management.
15746207|NCT04890639|Procedure|Acute Intermittent Hypoxia|Four hypoxia sessions consisting of a baseline during which participants breath normoxic, ambient air, followed by 15 cycles of hypoxia for up to 60 seconds, interspersed with 90 second normoxic breathing between hypoxic administrations.
15746208|NCT04890626|Drug|Emtricitabine/Tenofovir Disoproxil Fumarate 200 MG-245 MG Oral Tablet [TRUVADA]|Main randomization
15746209|NCT04890626|Drug|Baricitinib + dexamethasone|Rescue randomization
15746210|NCT04890626|Drug|Dexamethasone|Rescue randomization
15746211|NCT04890613|Drug|CX-5461|150 mg sterile lyophilized powder containing 1% sucrose
15746212|NCT04890600|Behavioral|well-being assessment|exploration of emotional, cognitive and behavioural resources of healthcare professionals
15746213|NCT04890587|Drug|AL8326 tablets|Tablet:10mg/tablet; administered orally once daily in part 1 and part 2, administered orally twice daily for continuous 28-Day cycles in part 3.
15746214|NCT04890574|Device|CellMist™ System|Open Label, Safety and Feasibility
15746215|NCT04890561|Drug|Lemborexant|Lemborexant oral tablets.
15746217|NCT04890535|Drug|Part 1 Dose Level 1: 25 mg TBAJ-587|Part 1 Dose Level 1: 25 mg TBAJ-587 5 mg/mL and 20 mg/mL oral suspension formulation
15746218|NCT04890535|Drug|Part 1 Dose Level 1: TBAJ-587 placebo oral suspension|Part 1 Dose Level 1: placebo oral suspension
15746219|NCT04890535|Drug|Part 1 Dose Level 2: 50 mg TBAJ-587|Part 1 Dose Level 2: 50 mg TBAJ-587 5 mg/mL and 20 mg/mL oral suspension formulation
15746220|NCT04890535|Drug|Part 1 Dose Level 2: TBAJ-587 placebo|Part 1 Dose Level 2: placebo oral suspension
15746221|NCT04890535|Drug|Part 1 Dose Level 3: 100 mg TBAJ-587|Part 1 Dose Level 3: 100 mg TBAJ-587 5 mg/mL and 20 mg/mL oral suspension formulation
15746222|NCT04890535|Drug|Part 1 Dose Level 3: TBAJ-587 placebo|Part 1 Dose Level 3: placebo oral suspension
15746223|NCT04890535|Drug|Part 1 Dose Level 4: 200 mg TBAJ-587|Part 1 Dose Level 4: 200 mg TBAJ-587 5 mg/mL and 20 mg/mL oral suspension formulation
15746224|NCT04890535|Drug|Part 1 Dose Level 4: TBAJ-587 placebo|Part 1 Dose Level 4: placebo oral suspension
15746225|NCT04890535|Drug|Part 1 Dose Level 5: 400 mg TBAJ-587|Part 1 Dose Level 5: 400 mg TBAJ-587 5 mg/mL and 20 mg/mL oral suspension formulation
15746226|NCT04890535|Drug|Part 1 Dose Level 5: TBAJ-587 placebo|Part 1 Dose Level 5: placebo oral suspension
15746227|NCT04890535|Drug|Part 1 Dose Level 6: 800 mg TBAJ-587|Part 1 Dose Level 6: 800 mg TBAJ-587 5 mg/mL and 20 mg/mL oral suspension formulation
15746228|NCT04890535|Drug|Part 1 Dose Level 6: TBAJ-587 placebo|Part 1 Dose Level 6: placebo oral suspension
15746229|NCT04890535|Drug|Part 2 Dose Level 1: XXX mg TBAJ-587|Part 2 Dose Level 1: XXX mg TBAJ-587 5 mg/mL and 20 mg/mL oral suspension formulation
15746230|NCT04890535|Drug|Part 2 Dose Level 1: TBAJ-587 placebo|Part 2 Dose Level 1: placebo oral suspension
15746231|NCT04890535|Drug|Part 2 Dose Level 2: XXX mg TBAJ-587|Part 2 Dose Level 2: XXX mg TBAJ-587 5 mg/mL and 20 mg/mL oral suspension formulation
15746232|NCT04890535|Drug|Part 2 Dose Level 2: TBAJ-587 placebo|Part 2 Dose Level 2: placebo oral suspension
15746233|NCT04890535|Drug|Part 2 Dose Level 3: XXX mg TBAJ-587|Part 2 Dose Level 3: XXX mg TBAJ-587 5 mg/mL and 20 mg/mL oral suspension formulation
15746234|NCT04890535|Drug|Part 2 Dose Level 3: TBAJ-587 placebo|Part 2 Dose Level 3: placebo oral suspension
15746235|NCT04890535|Drug|Part one food effect cohort|TBAJ-587 5 mg/mL and 20 mg/mL oral suspension formulation
15746236|NCT04890522|Drug|Triprilimab(JS001)|Maximum 6 cycles for combined therapy and maintenance for up to 2 years.
15746237|NCT04890522|Drug|Cisplatin|Maximum 6 cycles for combined therapy.
15746238|NCT04890522|Drug|5-Fluorouracil|Maximum 6 cycles for combined therapy.
15746239|NCT04890522|Drug|Gemcitabine|Maximum 6 cycles for combined therapy.
15746240|NCT04890509|Drug|Bemcentinib|Bemcentinib capsules will be administered orally.
15746241|NCT04890509|Other|SoC|The SoC will be administered based on local guidelines.
15746242|NCT04890483|Device|Transcranial direct current stimulation|tDCS: the energy of the anode (transcranial current stimulation) will have as its source a battery-powered DC generator and will be exerted by two electrodes measuring 5x7cm and attached to the head. The electrodes will be located of the primary motor cortex. The electrode with positive charge (anode) will be positioned at contralateral to the dominant limb and the negative charged electrode will be positioned in the supraorbital region ipsilateral to the dominant limb. The active current of direct transcranial stimulation will be applied with the intensity of electric current of 2mA and density of 0.057 mA/cm2 with duration of 20 minutes. During the session, patients will remain seated. Number of sessions: five times, once per day.
15746243|NCT04890470|Drug|Oxytocin|intranasal administration of oxytocin (24 IU)
15746244|NCT04890470|Drug|Vasopressin|intranasal administration of vasopressin (20 IU)
15746245|NCT04890470|Drug|Placebo|intranasal administration of placebo
15746246|NCT04890457|Device|Vagus nerve stimulation via tragus|The device will send stimulus intensity around 0.5mA via tragus in the left ear (based on participants' subjective report), delivered with a pulse width of 0.25 ms at 25 Hz. Stimulation will be active for 30 seconds, followed by a break of 30 seconds.
15746425|NCT04888949|Biological|Mesenchymal stem cell|1*10^8 cells are administered once a week, total four times intravenously.
15746252|NCT04890405|Procedure|Standardized FMT|The group includes 35 patients. They will receive standardized FMT. Fecal bacteria capsules are used for fecal bacteria transplantation, 16 capsules are used each time, each capsule contains 200mg of fecal bacteria, and it is used orally. It was given only once.
15746253|NCT04890405|Combination Product|Precision Flora Transplantation|The group includes 35 patients. They will receive Precision Flora Transplantation. They were used self-developed precision transplant capsules for precision flora transplantation. 4 capsules are used each time. Each capsule contains 400mg of various probiotics effective against diarrhea. It is used orally, once a day,for 28 days.
15746254|NCT04890392|Drug|PD-1 inhibitor(Tislelizumab) ,SOX(S-1+ Oxaliplatin)|S-1: 40~60mg Bid，d1~14, q3w. Oxaliplatin：130mg/m2，iv drip for 2h，d1, q3w. PD-1（Tislelizumab）:200mg,iv drip for at least 1h,d1,q3w. Stage I: PD1 inhibitor + SOX regimen (q3W) . Stage II: PD1 inhibitor + SOX regimen (q3W) Stage III: PD1 inhibitor + SOX regimen (q3W) . Efficacy evaluation,then followed by surgery.
15746255|NCT04890379|Drug|Dimethyl fumarate|Dimethyl fumarate 240mg orally twice daily for 3 consecutive days
15746256|NCT04890379|Drug|Placebo|Placebo 240mg orally twice daily for 3 consecutive days
15746257|NCT04890366|Drug|Dimethyl Fumarate|Dimethyl fumarate 240mg orally twice daily for 3 consecutive days
15746258|NCT04890366|Drug|Placebo|Placebo 240mg orally twice daily for 3 consecutive days
15746259|NCT04890353|Drug|Dimethyl fumarate|Dimethyl fumarate 240mg orally twice daily for 3 consecutive days
15746260|NCT04890353|Drug|Placebo|Placebo 240mg orally twice daily for 3 consecutive days
15746261|NCT04890340|Diagnostic Test|ARNA Breast|Women of the required age group, in case of suspicion of breast cancer, are sent to clarify the diagnosis for mammography or ultrasound of the mammary glands, or MRI. Based on the results of these studies, a biopsy is prescribed to make a final diagnosis. Before a biopsy to diagnose the presence / absence of breast cancer, patients do the blood sampling one time. The blood is processed in the Sponsor's laboratory. The test results are compared with the data obtained from the biopsy. The evaluation of the effectiveness of the method will be determined on the basis of the obtained data on the sensitivity and specificity of the test in relation to the reference method
15746262|NCT04890327|Other|Web-based family health history tool|Web-based tool that collects subject's family health history through a series of questions and generates a pedigree which documents a risk assessment report for the physician to use. The risk assessment report uses standard, validated risk scores including GAIL , CLAUS, BRCAPRO which measure breast cancer risk, and MMRPRO which measures endometrial cancer risk, MELAPRO which measures melanoma cancer risk, and PANCPRO which measures pancreatic cancer risk
15746263|NCT04890314|Other|Patient-reported questionnaire|Validated questionnaires administered at baseline, 8 months following treatment, and 12 months following treatment.
15746264|NCT04890301|Behavioral|CT guided biopsy for pulmonary nodule|"The technical process of the experimental group: ① design of puncture path, positioning and fixation of patients; ② puncture point positioning; ③ installation of navigation frame and template; ④ percutaneous lung biopsy guided by PT combined with CT.
~The technical process of the active comparator group: ① planning puncture path, positioning and fixation of patients; ② positioning puncture point; ③ CT guided percutaneous lung biopsy.
~The operation related information, complications and postoperative pathological results were collected."
15746265|NCT04890288|Procedure|Interventional randomized controled trial (RCT) comparing two oxygenation methods to reduce desaturation during intubation vs standard of care.|Demonstrate that airway management supported by oxygen supplementation (either HFNC or low flow oxygen) can prevent significant desaturation (SpO2 > 85%) among patients in pediatric intensive care units (PICU) and neonatal intensive care units (NICU).
15746266|NCT04890275|Other|Blood flow restricted resistance exercise (BFR)|Following a 5-minute low intensity warm-up, the BFR cuff will be placed at the most proximal portion of the leg inflated to 50% limb occlusion following standard BFR guidelines. Participants will then perform leg press including 1 set of 30 reps, then 3 sets of 15 reps at 20% 1RM. Rest for 5 minutes without cuff inflation. Cuffs will be re inflated and participants will perform knee extension including 3 x 15 repetitions at 20% 1RM.
15746267|NCT04890275|Other|Resistance exercise without blood flow restricted (NON-BFR)|Participants will follow the same exercise protocol as the blood flow restriction group but with out BFR.
15746268|NCT04890249|Device|Investigational IOL Model C1V000|IOL replaces the natural lens removed during cataract surgery.
15746269|NCT04890249|Device|Investigational IOL Model C2V000|IOL replaces the natural lens removed during cataract surgery.
15746270|NCT04890249|Device|Control IOL Model ICB00|IOL replaces the natural lens removed during cataract surgery.
15746271|NCT04890236|Drug|Duvelisib|Given PO
15746272|NCT04890236|Biological|Tisagenlecleucel|Given via infusion
15746273|NCT04890223|Behavioral|Brief MI intervention|Brief MI intervention
15746274|NCT04890223|Behavioral|Placebo intervention|Generic health advice consultations and self-help smoking cessation booklets
15746275|NCT04890210|Dietary Supplement|Early Diet Group|Initiation of clear fluid diet 1 hour after esophageal variceal ligation
15746276|NCT04890210|Dietary Supplement|Late Diet Group|Initiation of clear fluid diet 6 hours after esophageal variceal ligation
15746277|NCT04890197|Dietary Supplement|tahini|48 grams tahini
15746278|NCT04890197|Other|control|no intervention
15746279|NCT04890184|Dietary Supplement|grape juice|grape juice
15746280|NCT04890184|Other|control|no intervention
15746281|NCT04890171|Procedure|Endoscopic submucosal dissection|Endoscopic submucosal dissection by a endoscopist using endoscopic devices
15746282|NCT04890171|Procedure|Surgery|Gastrectomy with lymph node dissection by a surgeon
15746283|NCT04890158|Other|Prone positioning for a total of 6 hours daily|Prone postioning for 6 hours daily
15746284|NCT04890145|Device|RW-Precision-Coupler|Implantation of the RW-Precision-Coupler together with FMT-VORP 503
15746362|NCT04889508|Behavioral|Socio-emotional mental training|Core practice: Affect Dyad. In the Affect Dyad (AD), participants perform a 12-minute partner-based exercise which involves contemplating over one difficult situation and one situation which incurred gratitude in the past 24 hours. Both partners take turns speaking about the two situations while the other partner listens in a non-judgmental manner. While the participants elaborate on the situations, they are asked to focus on the bodily experience of the emotions generated during the situation. The goal of the exercise is to enhance coping with difficult emotions, empathic listening, social sharing, acceptance, and gratitude.
15746285|NCT04890132|Behavioral|VOR precision training|Subjects are rotated in yaw using a pseudo-random sum of sines motion (0.5 - 2.0 Hz), view a monitor 1 m away, and are instructed to move their avatar through a maze using a joystick. The size of the maze becomes smaller in real-time when they are successful so that the patient is at the limit of their acuity. This task requires patients to optimize dynamic visual acuity to threshold-level images while rotating. We predict that VOR precision will gradually improve during training and that after training VOR precision will be better than the pre-training data. The sham task is as above but the acuity required to see the maze will set at a much larger level so baseline visual precision will be adequate to perform the task easily.
15746286|NCT04890119|Diagnostic Test|tenosynovial tissue biopsy|Biopsy of tenosynovial tissue during surgery for amyloid aggregate search
15746287|NCT04890106|Drug|Test - Bimatoprost 0.01% Ophthalmic Solution|Subjects in one arm will receive one drop of the test drug in both the eyes every evening at approximately 10:00 pm ± 2 hours for 42 days.
15746288|NCT04890106|Drug|Reference - LUMIGAN® (Bimatoprost 0.01% Ophthalmic Solution)|Subjects in the second arm will receive one drop of the reference drug in both the eyes every evening at approximately 10:00 pm ± 2 hours for 42 days.
15746292|NCT04890080|Other|Pulmonary Rehabilitation|Exercise training consisted of supervised breathing, aerobic, strengthening and stretching exercises for 8 weeks, 2 days a week. Breathing exercises included pursed lip, diaphragmatic, thoracic expansion and basal expansion exercises. Strength training included the lower and upper extremities, and it was performed 8-10 repetitions, either against gravity or using free weight, according to patient tolerance.
15746293|NCT04890067|Other|Treatment of Osteosarcoma according the AIEOP/ISG OS 2021 recommendations (includes drugs, surgery, radiotherapy or any other received treatments)|This observational study collects all the treatments received by the patients according according the AIEOP/ISG OS 2021 and therefore includes drug/biological/surgical/ radiotherapy and any other applicable treatments
15746294|NCT04890054|Other|Fecal Immunochemical Test|Patients due for CRC screening are mailed a FIT test by the clinic or health plan
15746295|NCT04890054|Other|Interview|Participate in interviews to evaluate the implementation of the mailed FIT and patient navigation programs by the clinics and regional organizations
15746296|NCT04890054|Behavioral|Patient Navigation|Clinic staff are trained in Navigation, patients with an abnormal FIT are contacted about colonoscopy by patient navigators
15746297|NCT04890041|Drug|Avatrombopag|The subjects will receive avatrombopag treatment with an initial dose once a day. Platelet counts will be obtained weekly during the first 4 weeks and then every 2 weeks until the 8th week of the study. The dose adjustment range is 20 mg~ per week to 40 mg per day to maintain the platelet level between 50×10^9/L and 150×10^9/L. If the platelet count does not reach to 30×10^9/L after taking avatrombopag 40 mg once a day for 4 consecutive weeks, the treatment will be stopped. If the platelet count is more than 400×10^9/L after taking avatrombopag 20 mg once a day for 2 consecutive weeks, the treatment will be stopped.
15746298|NCT04890028|Radiation|F-DOPA PET/CT|"All subjects will be imaged
~1 time injection of 2 MBq/kg of 18F-DOPA"
15746299|NCT04890015|Procedure|Intraoperative transanal decompression tube placement|Intraoperatively under direct vision in the lower rectum, the balloon of the catheter will be inflated with 5-10cc of distilled water and it will be secured with a dressing / tape to the buttock connected to a collection bag.
15746300|NCT04890002|Device|Far-infrared emitting pyjamas|Clothing made in far infrared (FIR) - based textiles could be a sustainable way for alleviating sleep problems with many advantages. Firstly, the proposed far infrared textiles are made of man-made profiled fibers without the addition of chemicals such as ceramic additives or other related coatings.
15746301|NCT04890002|Device|Sham-pyjamas|The sham-pyjamas are made of pure cotton fibres and man-made fibres without the far-infrared emitting function.
15746302|NCT04889989|Device|Microwave Ablation|Percutaneous microwave ablation using the NeuWave Microwave Ablation System for non-small cell lung cancer or oligometastatic lung tumors
15746303|NCT04889976|Device|Double Active: Active home-use transcranial direct current stimulation (tDCS) and active app-based behavioral therapy (BT)|Transcranial direct current stimulation (tDCS) is delivered by the Flow device (Flow Neuroscience, Malmö, Sweden), consisting of a one-size-fits-all headset with circular electrodes (area = 22.9cm2). The anode is positioned over the left prefrontal cortex, and the cathode over the right prefrontal cortex. Current strength is set at 2mA (current density = 0,09mA/cm2) for 30 minutes, daily for 5 workdays in a row for the first 3 weeks, with twice-weekly sessions for the following 3 weeks (total of 21 sessions in 6 weeks). Active app-based BT consists of a smartphone app with an electronic therapist-avatar, delivering BT sessions within areas such as: behavioral activation, meditation, sleep hygiene, exercise, and healthy nutrition. The BT sessions are delivered concomitantly to the tDCS sessions (the tDCS device connects via bluetooth to the participant's smartphone app).
15746304|NCT04889976|Device|tDCS-only: Active home-use transcranial direct current stimulation (tDCS) and sham app-based behavioral therapy (BT)|Transcranial direct current stimulation (tDCS) is delivered by the Flow device (Flow Neuroscience, Malmö, Sweden), consisting of a one-size-fits-all headset with circular electrodes (area = 22.9cm2). The anode is positioned over the left prefrontal cortex, and the cathode over the right prefrontal cortex. Current strength is set at 2mA (current density = 0,09mA/cm2) for 30 minutes, daily for 5 workdays in a row for the first 3 weeks, with twice-weekly sessions for the following 3 weeks (total of 21 sessions in 6 weeks). Sham BT sessions will consist of free access to internet sites, after logging in the study app. The sham BT sessions are delivered concomitantly to the active tDCS sessions (the tDCS device connects via bluetooth to the participant's smartphone app).
15746305|NCT04889976|Device|Double sham: Sham home-use transcranial direct current stimulation (tDCS) and sham app-based behavioral therapy (BT)|Sham transcranial direct current stimulation (tDCS) is delivered by the Flow device (Flow Neuroscience, Malmö, Sweden), consisting of a one-size-fits-all headset with circular electrodes (area = 22.9cm2). The anode is positioned over the left prefrontal cortex, and the cathode over the right prefrontal cortex. The sham protocol consists of a fade-in and fade-out phases of 1mA for 45 seconds, followed by a silent period in between for the remaining 28 1/2 minutes. Sham BT sessions will consist of free access to internet sites, after logging in the study app. The sham BT sessions are delivered concomitantly to the sham tDCS sessions (the tDCS device connects via bluetooth to the participant's smartphone app).
15746306|NCT04889963|Biological|adypose mesenchymal conditioned medium and ligament derived conditioned medium|rabbit with posterior cruciate ligament rupture and treated with fibrin glue mix with adypose mesenchymal stem cells in hypoxic culture and ligament derived conditioned medium
15746307|NCT04889950|Device|Tixel C|Tixel C )Novoxel®, Israel) is a thermomechanical system developed for fractional treatment. The system is designed for the treatment of soft tissue by direct conduction of heat, enabling tissue coagulation combined with micro ablation with low thermal damage to the surrounding tissue.
15746308|NCT04889950|Device|LipiFlow|LipiFlow
15746310|NCT04889924|Radiation|Axillary Radiotherapy|Axillary radiotherapy without lymphadenectomy (level I and II) + level III and supraclavicular +/- internal mammary chain
15746311|NCT04889924|Procedure|Lymphadenectomy|Axillary Lymph node dissection
15746312|NCT04889911|Behavioral|Narrative Enhancement and Cognitive Therapy- Young Adult, Combined with Coordinated Specialty Care|NECT is a psychosocial intervention focused on addressing the effects of self-stigma on individuals diagnosed with severe mental illnesses. For the present study, the intervention will be modified to address the needs of youth who have recently experienced a first episode of psychosis.
15746313|NCT04889911|Other|Coordinated Specialty Care|Coordinated Specialty Care is an evidence-based, multimodal intervention for persons who have experienced a first episode of psychosis.
15746314|NCT04889898|Device|Digital recording of speech and swallow sounds using the Beiwe Digital Health App on a personal smartphone|[Patients only] Weekly completion of audio recordings of speech and swallowing performed at home by the subject using the study smartphone application on their personal device.
15746315|NCT04889898|Radiation|Modified Barium Swallow Study (MBSS)|[Patients only] MBSS is an instrumented evaluation of oropharyngeal swallowing function that is performed using videofluoroscopy.
15746316|NCT04889898|Behavioral|Speech Intelligibility Test (SIT)|[Patients only] The SIT is a standardized test for measuring speech intelligibility.
15746317|NCT04889898|Behavioral|SIT Scoring|[Listeners only] Listeners will judge the intelligibility of speech recordings made by patients in the study.
15746318|NCT04889885|Device|High-intensity laser therapy (HILT)|"HILT was done by Multiwave Locked System (MLS) laser therapy combining 2 laser wavelengths (808 and 905 nm) in order to strengthen the effects of HILT. The laser was applied on medial, lateral and posterior parts around the knee joint. The total energy per session was 562.5 Joules (J) which was done 2-3 times a week for a total of 10 sessions.
~Additionally, the participants received conservative treatment for knee OA such as education about the disease, proper activities, and exercise."
15746319|NCT04889885|Device|Sham laser|The control group received a sham laser (2-3 times a week for a total of 10 sessions) plus conservative treatment as in the intervention group. The laser machine was the same as in the intervention group; however, the laser was applied without releasing laser energy to the knee joint.
15746321|NCT04889859|Procedure|long Roux limb Roux-en-Y reconstruction|After standard laparoscopic distal gastrectomy with radical lymphadenectomy, the gastrointestinal continuity will be restored with Roux-en-Y reconstruction using 100 cm-long Roux limb and 50 cm-long biliopancreatic limb.
15746322|NCT04889859|Procedure|long biliopancreatic limb Roux-en-Y reconstruction|After standard laparoscopic distal gastrectomy with radical lymphadenectomy, the gastrointestinal continuity will be restored with Roux-en-Y reconstruction using 50 cm-long Roux limb and 100 cm-long biliopancreatic limb.
15746324|NCT04889833|Behavioral|hypnosis therapy|Pre-recorded hypnosis therapy audio recording with accompanying visual of a calm ocean to be played at least once daily for 7 preoperative days, the day of surgery, and for 7 days postoperatively.
15746325|NCT04889820|Drug|Neoadjuvant chemotherapy|In this study, patients with obstructive colon cancer will be divided into two groups; in the control group, curative surgery will be performed within 2 weeks after successful SEMS placement, and in the experimental group, 3 cycles of neoadjuvant chemotherapy will be administered into patients who undergo successful SEMS placement and then curative surgery will be performed after neoadjuvnat chemotherapy. After the surgery, adjuvant chemotherapy will be administered, and total perioperative chemotherapy will be administered with 12 cycles.
15746326|NCT04889820|Drug|Adjuvant chemotherapy|After the surgery, adjuvant chemotherapy will be administered, and total perioperative chemotherapy will be administered with 12 cycles.
15746327|NCT04889820|Procedure|Curative resection|After successful SEMS placement, curate resection will be performed for all enrolled patients regardless of neoadjuvant chemotherapy.
15746328|NCT04889807|Other|measure of EtCO2 variation|measure of EtCO2 (end tidal carbon dioxide) variation after an 15 seconds end-expiratory occlusion test
15746422|NCT04888988|Other|Exercise Intervention|Participate in the EXCAP exercise program (meeting with a counselor, receive follow-up meetings)
15746426|NCT04888949|Biological|Placebo|Commercially available saline.
15746329|NCT04889794|Other|GPS clinical intervention|Nurses and doctors in exposed FMGs and home care teams (HCTs) will be asked to refer to the FMG pharmacist all seniors undergoing cognitive evaluation OR referred to a memory clinic OR recently diagnosed with a cognitive disorder, for a complete and critical review of their medication therapy. FMG pharmacists will be asked to conduct an interview with each referred senior and his or her caregiver, if applicable, in order to establish the best possible treatment regimen. They will compare the information collected with another reliable data source (e.g., pharmacy records) in order to perform medication reconciliation and will then evaluate the medication related problems. Pharmacist will establish a care plan and the follow-ups to be carried out with the patient in collaboration with the health care team. There will be no drug or devices tested, it is a human clinical intervention by a pharmacist.
15746330|NCT04889781|Drug|Dexamethasone injection|Compare the effect of dexamethasone injection on reducing post-op pain after impacted third molar Surgery
15746331|NCT04889781|Procedure|Piezosurgery|Compare the effect of Piezosurgery device use on reducing post-op pain after impacted third molar Surgery
15746332|NCT04889781|Procedure|Conventional Rotatory instruments|Surgical extraction using conventional rotatory instruments to perform osteotomy
15746333|NCT04889768|Drug|HIPEC, anti-PD-1 antibody Camrelizumab (SHR-1210), Chemotherapy and Surgery|"HIPEC: Taxol (Paclitaxel Injection) 75 mg/m2, d1, d3 within 72 hours after surgical exploration; oral chemotherapy:S-1: 80mg/m2, twice daily for d1-d14, and then suspend for one week; Intravenous drip anti-PD-1 antibody Camrelizumab (SHR-1210) 200mg fixed dose every 3 weeks.
~Chemotherapy and PD-1 treatment (4 cycles) : Taxol 150mg/m2,d1; S-1: 80-120mg/m2, twice daily for two weeks, and then suspend for one week; Camrelizumab (SHR-1210) 200mg fixed dose every 3 weeks.
~Surgery: Secondary surgical exploration: if PCI less than 20, then assess the patient's condition and consider whether perform the cytoreductive surgery (resection of primary tumors and metastases ). For inoperable patients, continue to use this program for treatment.
~After the surgery, HIPEC for two cycles, anti-PD-1 antibody Camrelizumab (SHR-1210) for 4 cycles, and PS chemotherapy for 4 cycles."
15746334|NCT04889755|Behavioral|SibACCESS|The primary goal of the 8-session, SibACCESS program is to increase siblings' exposure and opportunity to process cancer-related cues to decrease onset or intensification of posttraumatic stress. Parents will participate in an initial 90-minute session where they will receive psychoeducation and brief skills training to support siblings enrolled in the program. Siblings will participate in 7-sessions where they will receive skills and strategies to confront information about cancer and tolerate uncomfortable thoughts and feelings, as well as how to communicate about cancer.
15746335|NCT04889742|Device|loco-regional hyperthermia|loco-regional hyperthermia by the use of microwave, capacitive, or superficial hyperthermia devices.
15746336|NCT04889716|Drug|mosunetuzumab|1 mg IV on Cycle 1 Day 1; 2 mg IV Cycle 1 Day 8; 60 mg IV Cycle 1 Day 15; 60 mg IV on Cycle 2 Day 1 and then 30 mg IV every 21 days beginning Cycle 2 Day 1 through Cycle 17.
15746337|NCT04889716|Drug|glofitamab|2.5 mg IV Cycle 1 Day 8; 10 mg IV Cycle 1 Day 15 then 30 mg every 21 days beginning Cycle 2 Day 1 through Cycle 12
15746338|NCT04889716|Drug|obinutuzumab|1000 mg IV on Cycle 1 Day 11.
15746339|NCT04889703|Drug|15% Trichloroacetic acid peel|Trichloroacetic acid peel (15%) will be applied topically to the face for 2 treatments at 4 week intervals.
15746340|NCT04889703|Drug|30% Salicylic acid peel|Salicylic acid peel (30%) will be applied topically to the face for 2 treatments at 4 week intervals.
15746341|NCT04889690|Drug|Danicopan|
15746342|NCT04889690|Drug|Placebo|
15746343|NCT04889677|Drug|Danicopan|
15746344|NCT04889677|Drug|Placebo|
15746345|NCT04889664|Drug|Ketamine|Repeated intravenous Ketamine infusions.
15746346|NCT04889664|Behavioral|Written Exposure Therapy|WET is a brief, 5-session evidence-based written trauma-focused therapy
15746347|NCT04889651|Drug|BR9004|BR9004: Abiraterone acetate 200mg, Boryung Pharmaceutical Co., Ltd.
15746348|NCT04889651|Drug|BR9004-1|BR9004-1: Zytiga Tab. 500mg (Abiraterone acetate 500mg), Janssen Korea
15746349|NCT04889638|Other|Cessation Intervention|"Pharmacotherapy selection, prescription and monitoring of up to two types of cessation pharmacotherapies: Nicotine replacement therapy (gum, lozenge and transdermal patch) and non-nicotine replacement therapy (varenicline).
~Remote video-conferencing and mobile phone-based, personalized motivational messaging"
15746350|NCT04889612|Procedure|hand motor coordination in a sitting positin|The subject sat on the therapeutic table (without back support), feet resting on the floor. The upper limb was to be examined in adduction of the humeral joint, with the elbow bent in the intermediate position between pronation and supination of the forearm, with free wrist and the hand. After putting the glove on, the subject was asked to make moves as quickly and in as full a range as possible. Finally, the measurement of grip strength with a dynamometer was performed.
15746351|NCT04889612|Procedure|hand motor coordination in a supine position|In the supine position, the upper limb was stabilized at the subject's body (adduction in the humeral joint, elbow flexion in the intermediate position, wrist and hand free). After putting the Hand Tutor glove on, the subject was asked to make moves as quickly and in as full a range as possible. Finally, the measurement of grip strength with a dynamometer was performed.
15746352|NCT04889599|Drug|BH009 (Docetaxel injection)|75mg/m2
15746353|NCT04889599|Drug|Docetaxel injection|75mg/m2
15746354|NCT04889586|Device|EMG-biofeedback armband (REMO)|After clinical evaluation, the subjects execute an instrumental test. By wearing EMG-biofeedback device (REMO), the subjects have to perform 10 different hand gestures: thumb abduction, pinch, finger flexion, finger extension, wrist flexion, wrist extension, forearm pronation, forearm supination, radial wrist deviation and ulnar wrist deviation. The muscle activations (EMG signals) during the execution of each movements, are recorded for 3 seconds.
15746356|NCT04889560|Other|Experimental group|Home-based version of a computerized cognitive training (CoRe)
15746357|NCT04889560|Other|Control group|Computerized cognitive training (CoRe)
15746358|NCT04889547|Drug|Dexamethasone|Intraoperative intravenous dexamethasone
15746359|NCT04889547|Other|No dexamethasone|No intraoperative intravenous dexamethasone
15746360|NCT04889534|Procedure|Analgesia|Patients will be observed during postoperative period,
15746361|NCT04889521|Other|No intervention|No intervention. Study is cross-sectional observational.
15746363|NCT04889508|Behavioral|Mindfulness-based mental training|Core practice: Breathing Meditation. In this intervention, participants will practice 12-minute basic attention-based mindfulness meditation such as the Breathing Meditation (BM). BM is a 12-minute individual exercise that requires participants to focus their attention on the sensations of breathing. Participants have to sustain their attention to breath for long stretches of time, and have to return their attention to their breath when their mind wanders. The key focus is on training attention and interoceptive body awareness. Other practices participants will be taught is mindfulness on sounds (here the object of attention is not the breath but sounds in the environment).
15746364|NCT04889495|Drug|Zirabev|Bevacizumab biosimilar
15746365|NCT04889482|Other|No intervention|No intervention
15746366|NCT04889469|Procedure|Breast reduction|Procedure to remove excess fat, tissue and skin from the breasts.
15746367|NCT04889456|Procedure|Implementation standardised laparoscopic right hemicolectomy with proctoring|Implementation standardised laparoscopic right hemicolectomy with proctoring
15746368|NCT04889456|Procedure|Implementation standardised laparoscopic right hemicolectomy without proctoring|Implementation standardised laparoscopic right hemicolectomy without proctoring
15746369|NCT04889443|Procedure|Surgical cartilage repair procedure requiring harvest procedure or Autologous Stromal Cell Implantation|Any surgical cartilage repair procedure of the knee that requires a harvest biopsy of knee cartilage, which will leave a controlled small cartilage injury
15746373|NCT04889391|Drug|[14C]-Danicopan|Liquid-filled capsules.
15746374|NCT04889378|Other|prehabilitation|very low calories diet (800-1000kcal/day) with moderate intensive aerobic exercise (1 hour per section; 3 sections per day)
15746375|NCT04889365|Diagnostic Test|SG Diagnostics COVID-19 Antigen Rapid Test Kit|SG Diagnostics COVID-19 Antigen Rapid Test Kit (self-use)
15746376|NCT04889365|Diagnostic Test|Polymerase chain reaction (PCR) test|Professional collection of a second swab sample, for confirmation by PCR
15746377|NCT04889352|Other|Access to colonoscopy web app|There is a very high utilization of colonoscopy at both shorter and longer time intervals than the recommended guidelines. Investigators have developed a clinical support tool in which the characteristics of the patients can be inputted and the guideline recommended time interval for surveillance colonoscopy is then provided. This tool uses the recommendations from the current North American national guidelines. The tool has been developed as a web-based application (http://colonoscopy.thelizardlab.net/) as well as a smart phone application.
15746378|NCT04889339|Device|Test brace versus control brace: Immediate correction|The trunk surface will be scanned to reconstruct a numerical model of the patient's trunk, this reconstruction will help to produce the optimized brace. The patient skeletal will also be reconstructed from a bilateral radiograph using an EOS imaging system. Each patient will try both the control and the test brace. Radiographic and patient-reported data will be gathered and analyzed to observe changes between the immediate correction of the braces. The SRS-22r will be collected. The study protocol requires no additional visits beyond the standard of care. There will be one additional radiograph compared to the standard of care.
15746379|NCT04889339|Device|Test brace versus control brace: Long-term correction|After comparing the immediate correction of the braces, each patient will be using either the test or the control brace for a period of two years. There will be follow-up visits, between 6 months and 1 year depending on the patient growth. The brace will be renewed using the same procedure to adapt to the patient's growth. The study protocol requires no additional visits beyond the standard of care. There will be no additional radiograph compared to the standard of care. Compliance monitors are installed in each brace.
15746380|NCT04889326|Other|Retrospective data and biological samples|Analysis of data and biological samples collected during hospitalization:
15746381|NCT04889300|Behavioral|Best Possible Self|Participants are asked to think about their Best Possible Self for one minute, then describe it for 15 minutes (in writing) and, subsequently, imagine it for another 5 minutes as vividly as possible.
15746382|NCT04889300|Behavioral|Typical Day|Participants are asked to think about their Typical Day for one minute, then describe it for 15 minutes (in writing) and, subsequently, imagine it for another 5 minutes as vividly as possible.
15746383|NCT04889287|Drug|Elinzanetant (BAY3427080)|Once daily over 12 days
15746384|NCT04889287|Drug|Rosuvastatin|Single doses on Day 1, Day 8, and Day 13
15746385|NCT04889274|Biological|COVID-19 vaccine|COVID-19 vaccine as offered by NHS England
15746386|NCT04889274|Biological|Concentrate beetroot Juice|Beetroot juice containing approximately 5mmol/l nitrate
15746387|NCT04889274|Biological|Nitrate-deplete beetroot juice|Beetroot juice with nitrate removed
15746388|NCT04889248|Other|Inspiratory Muscle Training with Powerbreath IMT device.|"Inspiratory muscle training with Powerbreath IMT device, for a duration of 8 weeks.
~Each day, each subject perform 15 repetitions in the morning and evening, from Monday to Friday, resting on weekends.
~The endurance of the device increases along the study, initiating with the 30% of their own maximum inspiratory pressure (PImax) during the first week and increasing a 10% every other week, till reach the goal of 60% PImax."
15746389|NCT04889235|Procedure|Major liver resection|All patients undergo Major hepatic resection, differences between sarcopenia and no-sarcopenia groups will be observed
15746427|NCT04888910|Other|observational|observation of biomarkers in different asthma groups
15746394|NCT04889196|Drug|Silver diamine fluoride|Previous studies have recommended that Silver diamine fluoride (SDF) solution would exert a preventive result in managing early childhood caries ECC. However, no well-designed clinical trials have yet been performed to study the effect of SDF on caries prevention. the objective is useful in arresting early childhood caries (ECC)
15746395|NCT04889196|Device|hall technique|The first report on the Hall Technique published in 2007 by a general dental practitioner from Aberdeen/Scotland, Dr. Norna Hall. Dr. Hall used PMCs to restore carious primary molars rather than using the standard technique, placed them using a simplified method.
15746396|NCT04889183|Drug|Semaglutide|Patients will be treated for 24 weeks with semaglutide 3.0 mlg/ml s.c. once weekly. The starting dose of semaglutide will be 0.24 mg per week subcutaneous injection with increasing doses at 4, 8, 12, and 16 weeks to 0.5, 1,0, 1.7 and 2.4 mg.
15746397|NCT04889183|Drug|Placebo|Patients will receive a matching placebo sc. once weekly during the treatment period of 24 weeks.
15746398|NCT04889170|Other|Intervention|"Intervention: After recording the patient characteristics and the baseline dysphagia characteristics, the intervention begins. The intervention lasts 3 weeks, by extended stay it lasts 5 or 7 weeks.
~The intervention has two parts. One part of the intervention is the biofeedback therapy. The biofeedback therapy means that the patient and an SLT watch the video of the FEES together and discuss the findings. The other part of the intervention is a swallow training or a voice training. The frequency of therapy is minimum 3 times a week, the duration of one therapy is minimum 25 minutes.
~Allocation to the Groups will be done by a randomization software"
15746399|NCT04889157|Drug|PF-06882961|Participants will be administered active doses, taking 3 tablets twice daily (BID) for 8 weeks except Day 1 (QD)
15746400|NCT04889157|Drug|Placebo|3 matching placebo tablets taken twice daily (BID) except Day 1 (QD)
15746401|NCT04889144|Behavioral|Planning for Your Advance Care Needs (PLAN)|PLAN is a manualized intervention that helps patients learn about, plan for, and communicate their advance care plans to their loved ones and doctors. It consists of five modules delivered across three sessions with a trained and licensed social worker: (1) checking awareness; (2) clarifying; (3) knowledge transferring; (4) goal setting; and (5) rehearsing.
15746402|NCT04889131|Behavioral|Yoga Program Immediately|free 12 week yoga program, twice a week for 75 minutes each
15746403|NCT04889131|Behavioral|Wait-Listed Control|assigned to take the Yoga Program in 12-weeks
15746404|NCT04889131|Other|Activity Monitor|Garmin VivoSmart activity monitor throughout study
15746405|NCT04889118|Biological|Pembrolizumab|IV infusion
15746406|NCT04889118|Drug|Lenvatinib|Oral capsule
15746407|NCT04889118|Drug|Placebo for lenvatinib|Oral capsule
15746408|NCT04889105|Behavioral|Smart MOVE!|"Multi-component behavioral intervention of PAD consisting of:
~guideline-directed HBET prescription
~active behavioral coaching (via MOVE! program or other)
~mobile health monitoring"
15746409|NCT04889105|Behavioral|General walking advice|Basic guidance on performing walking exercises for PAD according to established guidelines. Participants will receive a mobile health device for self-tracking only but not receive any behavioral coaching.
15746410|NCT04889105|Behavioral|Performance evaluation|"Preliminary performance evaluation determine the optimal components of the Smart MOVE! intervention. Specific procedures will include:
~Provider and stakeholder interviews
~PAD patient interviews
~2) N-of-1 trials to refine the intervention"
15746411|NCT04889092|Other|Blood Flow Restriction exercise|Exercise training will consist of blood flow restriction exercise. Specifically blood pressure cuff will be wrapped around the most proximal portion of the thigh and inflated to a pressure that is 80% of the pressure required to completely occlude femoral blood flow. With the cuff inflated the subject will perform a series of knee extension/flexion exercise protocol. This consists of 30 reps, 15 reps, 15 reps and 15 reps all separated by 1 minute of recovery. All reps will be performed at 30% of the subjects 1 repetition max. This will be preformed 20 times over 8 weeks.
15746412|NCT04889092|Other|Traditional resistance exercise|Traditional knee extension/flexion exercise will be performed. This will consist of a series of 13 reps, 12 reps, 12 reps with 1 minute recovery between each set. The resistance will be set at 60% of their 1 repetition max. This will be performed 20 times across 8 weeks.
15746413|NCT04889079|Behavioral|Contraceptive use (continuation/switching/discontinuation)|Assessing contraceptive continuation/switching/discontinuation over 12-months
15746414|NCT04889066|Radiation|Stereotactic Radiation Therapy|24-27 Gy in 3 fractions- one plan, given once every other day with first cycle of Durvalumab for comparator arm. 24-27 Gy in 3 fractions- each re-planned, given once every 4 weeks with each Durvalumab for experimental arm.
15746415|NCT04889066|Drug|Durvalumab|Durvalumab (initially developed as MEDI4736) is a human monoclonal antibody of the immunoglobulin (Ig) G1 kappa subclass that inhibits binding of PD-L1 (B7-H1, CD274) to PD-1 (CD279) and CD80 (B7-1). MEDI4736 is composed of 2 identical heavy chains and 2 identical light chains, with an overall molecular weight of approximately 149 kDa. MEDI4736 contains a triple mutation in the constant domain of the Ig G1 heavy chain that reduces binding to complement protein C1q and the fragment crystallizable gamma receptors involved in triggering effector function.
15746416|NCT04889040|Drug|RO7496998|275 mg tablets
15746417|NCT04889040|Drug|Placebo|Matching tablets
15746418|NCT04889027|Diagnostic Test|Standardized Infant NeuroDevelopmental Assessment|The neurological scale of SINDA is designed as a screening tool as follows: (1) in the first year of life after the neonatal period, that is, in the corrected age range of 6 weeks to 12 months; (2) covers all infant neurological areas; (3) it is standardized, that is, it has a set of items and criteria identical to that age range; (4) results in a score that is largely independent of the baby's age; (5) general pediatricians are easy to use and take about 10 minutes to do (including recording scores); (6) contains a substantial part of items assessing the quality of spontaneous movements; and (7) helps predict developmental outcome (Hadder-Algra et al., 2018).
15746419|NCT04889014|Genetic|Personal genomic educational testing (PGET)|PGET consisted of a panel of pharmacogenomic variants
15746420|NCT04889014|Genetic|No personal genomic educational testing (NPGET)|Lack of pharmacogenomic testing
15746421|NCT04889001|Other|Simulation enhanced HBB training|Simulation enhanced HBB is a one-day course delivered using a format of Explain, Demonstrate and Facilitate practice. Compared to the standard HBB training, the simulation enhanced HBB course is designed with increased peer-to-peer feedback and scripted expert facilitator feedback at HBB practice exercises.
15782112|NCT04596267|Drug|Placebo|Inert ingredients
15746428|NCT04888858|Drug|Epidural analgesia (0.125% bupivacaine/2mcg fentanyl solution)|As part of standard protocol for all patients who receive a labor epidural, the epidural will then be tested using 3ml of 1.5% lidocaine and 1:200,000 epinephrine test solution, and the epidural catheter will then be loaded with 10ml of 0.125% bupivacaine solution. The epidural catheter will then be connected to a programmed intermittent epidural bolus pump which will administer 5ml of a 0.125% bupivacaine/2mcg fentanyl solution every 30minutes. The first dose will be given following 30minutes after the loading dose. 30 minutes after loading the loading dose and after the first pump dose has been given, we will assess the VAS pain scores and the level of the analgesic based on decreased sensation to ice.
15746429|NCT04888845|Behavioral|Safety Plan|The safety plan is a written, prioritized list of coping strategies and resources for reducing suicide risk.
15746430|NCT04888845|Behavioral|Crisis Response Plan|Crisis response planning intervention teaches a range of coping strategies and provides support that can reduce suicide attempts and ideation.
15746431|NCT04888845|Behavioral|Structured interview|In the structured interview approach, clinicians ask a series of predetermined questions and/or assess a specified set of risk and protective factors, typically using a checklist-based approach.
15746432|NCT04888845|Behavioral|Narrative Assessment|"In the narrative assessment approach, clinicians ask patients to tell the story of their suicidal crisis."
15746433|NCT04888832|Other|Work requirement exemption months|Cross-randomized intervention will test effect of additional exemption months before work requirements in SNAP become binding and extensions of the standard SNAP recertification period.
15746434|NCT04888819|Drug|DWP14012|DWP14012 40 mg, orally, once daily just after a meal up to 4 weeks
15746435|NCT04888819|Drug|DWP14012|DWP14012 40 mg, orally, once daily before a meal up to 4 weeks
15746436|NCT04888806|Drug|Camrelizumab|d1，200mg, iv, q3w
15746437|NCT04888806|Procedure|ablation|the 37 enrolled patients received ablation of liver/lung metastases ，If the patient has multiple metastatic tumors, ablation therapy needs to be performed in multiple times.
15746438|NCT04888806|Drug|chemotherapy|standard treatment plan for mCRC, determined by the investigator
15746439|NCT04888793|Diagnostic Test|Serologic immune response evaluation|Detection of total and neutralizing antibodies against SARS-CoV-2
15746440|NCT04888780|Other|The web-based Watson's Human Care Theory oriented training|Video calls were held every 15 days via the skype program with complete adherence to the schedule. In these interviews, the clinical picture of diabetes and the psychosocial status of adolescents were discussed. A total of 14 interviews with 15-day intervals were made with each adolescent. All video interviews were carried out by the first researcher and they were all recorded.
15746441|NCT04888767|Other|Interval Training Hight Intensity Program|"Rehabilitation stay in hospitalization with 18 days of training sessions
~Training on an ergometer
~Sessions supervised by an Adapted Physical Activities (APA) teacher or a physiotherapist
~Control group: 5 times / week; continuous work 20 to 30 min; around the 1st aerobic ventilation threshold
~Intervention group: 2 times / week: maintenance sessions + 3 times / week: IHTI sessions - alternating 30s work / 30s rest repeated 6 times; at 60% of the maximum heart rate at the 1st session then increase as fast and large as possible"
15746442|NCT04888741|Drug|Thymoglobulin|GVHD prophylaxis
15746443|NCT04888741|Drug|Cyclophosphamide|Post transplant cyclophosphamide strategy for GVHD prophylaxis
15746444|NCT04888741|Drug|Cyclosporine|immunosuppressant
15746445|NCT04888741|Drug|Sirolimus|immunosuppressant
15746446|NCT04888741|Drug|Mycophenolate Mofetil|immunosuppressant
15746447|NCT04888728|Drug|DWN12088|Prolyl-tRNA synthetase (PRS) inhibitor
15746448|NCT04888728|Drug|Nebivolol|Nebivolol
15746449|NCT04888728|Drug|Paroxetine|Paroxetine
15746450|NCT04888715|Drug|DWN12088|Prolyl-tRNA synthetase (PRS) inhibitor
15746451|NCT04888715|Drug|Pirfenidone|Pirfenidone
15746452|NCT04888715|Drug|Nintedanib|Nintedanib
15746453|NCT04888702|Device|Actimyo|Actimyo° is an innovative device intended to be used in a home-based environment. It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle.
15746454|NCT04888689|Device|Actimyo°|Actimyo° is an innovative device intended to be used in a home-based environment. It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle.
15746455|NCT04888689|Device|IMU|"IMU is a portable system of miniaturized inertial sensors for objective, instrumental, ambulatory, and validated analysis of normal and pathological human gait. Each miniaturized inertial sensor (2 cm × 0.7 cm × 0.5 cm) includes a triaxial accelerometer and a triaxial gyroscope.
~These four inertial sensors are connected to a box by wires and are numbered 1 to 4. They must be attached - using adhesive tapes - on the participant's shoes."
15746456|NCT04888676|Procedure|Class II Restoration|A Class II cavity will be prepared after local anesthesia has been given as required.Rubber dam isolation will be done.Sectional matricing and wedging will be done. Followed by, placement of restorative material according to the randomization sequence.followed by filling of cavity in increments of 3-4mm
15746457|NCT04888663|Drug|Trastuzumab + Ramucirumab + Paclitaxel|For both Phase Ib and II: Trastuzumab 4 mg/kg (loading dose) followed by 2 mg/kg on Days 1, 8, 15 and 22, and ramucirumab 8 mg/kg on Days 1 and 15, as well as paclitaxel will be administered intravenously in a 4-week cycle (every 28 days) For Phase Ib, Paclitaxel 80 or 70 mg/m2 (according to dose level) will be administered on Days 1, 8, 15 For Phase II, paclitaxel at RP2D (80 or 70 mg/m2) will be administered on Days 1, 8, 15 of each cycle
15746458|NCT04888650|Other|questionnaire|electronic questionnaire
15746459|NCT04888637|Diagnostic Test|Baseline MEG Test|Each subject will have one MEG session with the recordings of baseline resting state, language and memory protocols. Subjects will have a break period between the language and memory tasks. MEG recordings will be acquired for approximately 35 minutes. The subject will be allowed to practice the language and memory tasks before the MEG recording to feel familiar with them. This practice phase will be a short version of the task administered by a computer and will take approximately 6 minutes.
15746508|NCT04888169|Device|SMART Mobile App - Attention Bias Modification|ABM involves placing the probe behind the neutral stimulus on 100% of the trials.
15746460|NCT04888637|Behavioral|Receptive Language Task|"The subject will perform a practice session where they will be instructed to try to remember a set of ﬁve audibly spoken English words, deemed targets (jump, little, please, drink, and good). Depending on the subject's overall verbal memory capacity, the target words will be presented once or twice during the practice phase. Subsequently, during the MEG recording, the ﬁve target words will repeat in a different random order, mixed with a different set of 40 distractors (non-repeating words) in each of three blocks of stimuli. The subject's task will be to listen to the words and lift their index finger of the dominant hand whenever they hear a repeated target word (one of the five). After the language task, the subject will be given a break."
15746461|NCT04888637|Behavioral|Memory Task|"The subject will be tasked with indicating whether the encoding stimulus matched the retrieval stimulus using two buttons; one for congruent and the other for incongruent response. Button type will be counterbalanced among subjects. The task will take around 16 minutes. The visual stimuli will be projected through an LCD projector onto a white screen located about 0.5 m in front of the subject and subtending 1.0-4.0 and 0.5 degrees of horizontal and vertical visual angle, respectively. A MEG compatible keyboard will be used to measure the subject's responses for congruent and incongruent. The subject will practice the memory task before going to the MEG system using a computer from MEG laboratory. This practice phase will consist of a short version of the memory task with duration of approximately 4 minutes."
15746462|NCT04888624|Device|DrySee® dressing with moisture detection|DrySee® is a waterproof bandage designed to protect surgical incisions. It contains an indicator at the perimeter of the dressing, and at the wound site that turns blue when it comes into contact with liquid (figure 1). The indicator identifies a break in the integrity of the postoperative dressing. Changing the dressing at this point prevents bacteria from reaching the incision reducing the risk of infection. In addition, the waterproof dressing allows patients to shower or bath following surgery.
15746463|NCT04888624|Device|Tegaderm® + Pad transparent film dressing|Tegaderm® is a transparent adhesive dressing commonly used as a postoperative dressing. The dressing has been shown to be superior to gauze in reducing SSIs. Tegaderm®, like DrySee,® is waterproof; however, it lacks technology that identifies a breach in dressing integrity.
15746466|NCT04888598|Diagnostic Test|Optical Coherence Tomography (OCT) Angiography|Measurement of retinal vessel density and distribution in the macula using new generation OCT device
15746469|NCT04888572|Radiation|Peri-Apical X-ray|"Using a PCP UNC 15 Hu Friedy® periodontal probe and a gentle horizontal sweeping motion through the peri-implant tunnel or sulcus the examiner will assess bleeding on probing, the main factor in determining peri-implant inflammation and subsequently possible peri-implantitis. Then, using the same instrument, the author will examine whether there is an increase in the values of pocket depths compared to the initial values, highlighting an installation of peri-implant disease. Radiographically, evidence of bone loss after healing through taking a digital x-ray that will be viewed on DBSWIN® software will help authors make a diagnosis of peri-implantitis as well. It will be required that the digital film be perfectly parallel to the axis of the implant and the X-ray tube perpendicular to them in order to have an orthogonal radiograph."
15746470|NCT04888559|Other|Breakfast product: Whole grain|This intervention is a whole grain-based breakfast product containing oats and barley.
15746471|NCT04888559|Other|Breakfast product: Reference|This intervention is a rice-based breakfast product.
15746472|NCT04888546|Drug|Anlotinib hydrochloride capsules＋ TQB2450 injection|"Anlotinib hydrochloride capsules is a new type of small molecule multi-target tyrosine kinase inhibitor against angiogenesis.
~TQB2450 is a humanized monoclonal antibody targeting PD-L1, which prevents PD-L1 from binding to the PD-1 and B7.1 receptors on the surface of T cells, so as to restore the activity of T cells and thereby enhance the immune response, and has the potential to treat various types of tumors."
15746473|NCT04888533|Other|EHSSA- An Efficient and Holistic/Heuristic Semi-structured Suicide Assessment Tool|EHSSA will be used to evaluate every patient for suicide risk.
15746474|NCT04888520|Device|Adhesive elastic bandage|"The base of the tape should be applied 5 cm below the origin of the rectus femoris (lower anterior iliac spine), going towards its insertion (base of the patella, through supra-patellar ligament), without tension in this part of the tape (2 to 3 cm initial) in order to avoid discomfort. The application mode will be in I (I-strip). The participants will be in the supine position, with the hip flexed at 30° and the knee flexed at 60°. The applications of the tape will be carried out every Monday, before the first day of running training of the week and should remain until Friday, when it will be removed by the researcher after the last day of running training of the week. If the elastic bandage unstuck alone from the skin before this period, the event should be immediately reported to the therapist."
15746475|NCT04888507|Drug|Pozelimab|Intravenous (IV) loading dose (once) followed after 30 minutes by sub-cutaneous (SC) administration
15746476|NCT04888507|Drug|Cemdisiran|SC administration
15746479|NCT04888481|Drug|68Ga-HA-DOTATATE|Tracer injection
15746480|NCT04888468|Biological|pCAR-19B cells|Drug: pCAR-19B cells； Administration method: intravenous infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.
15746507|NCT04888182|Dietary Supplement|intervention|a protein intake of ≥25 E%. An oral nutritional supplement (containing 1570 kJ/100 g and 92 g protein/100 g. Atpro 200) was used as supplement to the patients' habitual diet.
15746481|NCT04888455|Diagnostic Test|Quantitative sensory testing (QST)|Demographic data, pain characteristics, health status, emotional well-being, personality and lifestyle are assessed by questionnaires. Additionally, all patients underwent a clinical neurological examination and quantitative sensory testing (QST) according to the German Research Network on Neuropathic Pain (DFNS).
15746482|NCT04888442|Biological|pCAR-19B cells|Drug: pCAR-19B cells； Administration method: intravenous infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.
15746483|NCT04888429|Drug|Camrelizumab|Patients received camrelizumab 200 mg every 3 weeks
15746484|NCT04888429|Drug|Famitinib|Patients received Famitinib 20 mg once per day
15746485|NCT04888416|Behavioral|I-STROM|I-STROM is a combination of the following implementation strategies: (a) initial and ongoing training, (b) learning collaboratives/knowledge sharing meetings, and (c) outcome measure champions
15746486|NCT04888403|Drug|Toripalimab+Nedaplatin+Albumin Paclitaxel|"Toripalimab 240mg administered intravenously (IV) on Day 1 of each 21-day cycle for 1 cycles.
~Other Names:Toripalimab+Nedaplatin+Albumin Paclitaxel Neoadjuvant radiotherapy after 2W: The radiotherapy dose is 41.4Gy, completed in 23 times, 5 times a week, using intensity-modulated radiotherapy (IMRT) or volume-modulated radiotherapy (VMAT); In the same period, albumin paclitaxel combined with nedaplatin chemotherapy: albumin paclitaxel 60mg/m2 + nedaplatin 25mg/m2, performed once a week, 5 times in total; Simultaneous immunotherapy: 240 mg of Toripalimab (PD-1 antibody), once every 3 weeks, 4 times in total; Received radical resection of esophageal cancer within 7 weeks after radiotherapy and chemotherapy.
~Other Names:Toripalimab+Nedaplatin+Albumin Paclitaxel"
15746487|NCT04888390|Behavioral|Muti-model exercise intervention|The Muti-model exercise intervention include aerobic exercise training by ergometer or treadmill, resistance exercise by using elastic band and flexibility exercise by active stretch. The total training program takes for 60 minutes, 2-3 times per week for 3 months.
15746488|NCT04888390|Behavioral|Disease and exercise suggestion|The participants will be provided by educational program about heart failure self-care and home-based exercise approach.
15746491|NCT04888351|Other|Comparison of complications between mastectomies with IBR and mastectomies without IBR|"Precocious complications (less than 3 months after surgery) are classified with Clavien's classification : hematoma, seroma, stitches, antibiotics, transfusion.
~Tardive complications (after 3 months until 1 year) are more specifics : hematoma, seroma, tardive infections, asymmetry, removing of implant, breaking up of implant, skin necrosis, capsular contractures, implant loss, chronic pain."
15746492|NCT04888351|Other|To analyze variations of number of patients eligibles to IBR|Including patients with differents classic risk factors : T3, T4, tobacco, diabetes, overweight and obesity, hypertension, age over 70, thoracic irradiation in the past
15746493|NCT04888338|Other|Data Capture|Treatment related data is collected
15746494|NCT04888338|Other|Electronic Medical Record|Medical records are reviewed
15746495|NCT04888325|Other|Oral glucose|Oral glucose consumption (1.25 grams/kg in 200 ml water at time 0 and the same amount again at 3 hours). During the 6-hour observation period infusion of normal saline (NaCL 0,9%) at a rate of 0.83 plus Heparin, 800 IU/h with a priming dose of 1000 IU.
15746496|NCT04888325|Other|Intravenous glucose|10% intravenous glucose infusion at a rate of 3.6 ml/kg/h plus Heparin 800 IU/h with a priming dose of 1000 IU will be administrated for 6 hours. Consumption of 300 ml of water at 0 and 3 hours
15746497|NCT04888312|Biological|CD40 agonist mitazalimab in combination with chemotherapy|Mitazalimab administered intravenously every 14 days in combination with standard of care chemotherapy modified FOLFIRINOX.
15746498|NCT04888299|Device|Raman spectroscopy (SPECTRA IMDx)|The SPECTRA IMDx comprises a laser system, a spectrometer, a computer with an analysis algorithm installed, and other ancillary parts. The SPECTRA IMDx probe is connected with the main system. The SPECTRA IMDx probe is an assembly of optical fibres and optical components arranged for maximal transmission of light energy. When in use, the laser system will emit a 785nm near infra-red laser that will be transmitted through the SPECTRA IMDx probe to the distal end. When the laser is interrogated upon a tissue surface, the light energy is absorbed and reflected. The reflected energy is then collected from the distal end of the SPECTRA IMDx probe, transmitted back to the main system, and passed through the spectrometer. The collected signal is then processed to obtain the clean Raman signal for diagnostic classification.
15746499|NCT04888273|Behavioral|Transition Intervention|Each adolescent-parent pair will be invited to complete 5 components of the intervention (peer support session, parent education session, transition meeting with healthcare providers, family doctor contact, and reading a transition navigation guide) over a 3-month period. These intervention components were designed with the intention of making the transition process transparent for the duo, preparing the adolescent to take responsibility of their own health as it relates to their disorder, and helping the parent step back from the process to help the adolescent integrate to adult care better.
15746500|NCT04888260|Other|Laboratory parameter levels in blood samples|Mannose and lipid parameters (triglyceride, LDL, HDL, VLDL) will be analysed in blood samples by using ELISA method.
15746501|NCT04888247|Device|CLARITY|Trans-septal mitral valve replacement
15746502|NCT04888234|Drug|Ru-Yi-Jin-Huang Powder|Ru-Yi-Jin-Huang Powder is the most common TCM topical drug for skin diseases. It is often used to treat skin ulcers, sprain of joint with swelling, and other inflammatory diseases.
15746503|NCT04888221|Drug|Tocilizumab|"Tocilizumab will be administered subcutaneously at a dose of 162mg/0.9mL weekly (each week, on the same day) from week 0 to week 24.
~At the first injection (Baseline D0), a therapeutic education is provided for patients/caregivers who can carry out the injections themselves as part of their usual care."
15746504|NCT04888221|Drug|Placebo|Placebo administered subcutaneously (SC) weekly during 24 weeks
15746505|NCT04888208|Behavioral|Behavioral|The intervention group will benefit from discussion sessions on tobacco within the virtual world, with a group of pairs and 2 facilitators (public health researchers).
15746506|NCT04888195|Other|Questionnaire|Participants will complete a set of validated questionnaires (TRSC-C and demographic sheet) before chemotherapy. They also have to complete the same questionnaires (TRSC-C) again within 1 week after the 1st, 2nd, 3rd, 4th , 5th and 6th courses of chemotherapy via telephone interview by our research assistants.
15746509|NCT04888169|Device|SMART Mobile App - Attention Control Training|ACT involves placing the probe behind the neutral stimulus on 50% of trials, and behind the threat stimulus on 50% of trials.
15746510|NCT04888169|Device|SMART Mobile App - Placebo Training|Placebo training only includes neutral stimuli.
15746511|NCT04888169|Device|SMART Mobile App - Control|Participants will only answer questions.
15746512|NCT04888156|Other|Unchanged treatment|Treatment is the same pre- and post self-tonometry
15746513|NCT04888156|Other|Changed treatment|Treatment is changed post self-tonometry
15746514|NCT04888143|Other|questionnaires|evaluation of hearing performance and quality of life questionnaires
15746515|NCT04888143|Other|Evolutionary algorithm|application of the evolutionary algorithm and customized frequency allocation on a separate program.
15746516|NCT04888130|Genetic|Phylogenetic Analysis|The phylogenetic analysis is carried out on a sample already taken in routine care (smear, culture on biopsy or PCR on swab).
15746517|NCT04888130|Other|Data collection|Data will be collected using a standardized digital questionnaire, including clinical and microbiological features, treatments received details and training conditions and. Data will then be compared between patients with therapeutic success or failure.
15746518|NCT04888117|Procedure|Laparoscopic cholecystectomy|With the patient under general anesthesia, several small incisions are made in the abdomen. Ports are placed, the abdomen is insufflated, and laparoscopic instruments as well as a laparoscope are inserted to complete the cholecystectomy according to the surgeon's standard practice.
15746519|NCT04888117|Procedure|Robotic-assisted cholecystectomy|With the patient under general anesthesia, several small incisions are made in the abdomen. Ports are placed, the abdomen is insufflated, and the da Vinci Robotic Surgical System (Intuitive) is docked to the patient and used to complete the cholecystectomy according to the surgeon's standard of care.
15746520|NCT04888104|Procedure|Index or revision spine surgery for complex adult spinal deformity|Adult patients receiving minimum 5 level posterior spinal fusion with pedicle screw fixation supplemented at the proximal aspect of the construct with the VersaTie System.
15746521|NCT04888091|Procedure|Cotton swab|Removal of the cervical mucus with a cotton swab before embryo transfer.
15746522|NCT04888091|Procedure|Cannula|Removal of the cervical mucus with a cannula before embryo transfer.
15746523|NCT04888078|Procedure|Bassini hernia repair|Non-mesh tissue inguinal hernia repairs
15746524|NCT04888052|Device|Acute ACL injury|Quantification of the preoperative deficits, by an isokinetic dynamometer, in order to adapt the care management of patients found with a muscle deficiency. Patients with preoperative knee extensor deficits > 15% will benefit from an additional preoperative rehabilitation protocol (8 weeks).
15746526|NCT04888026|Device|Quantitative sensory testing|"The following QSTs are conducted:
~The pressure pain threshold on the tibialis anterior
~The Cold-pressor test
~Repeat of the pressure pain threshold to assess conditioned pain modulation"
15746527|NCT04888013|Other|Positive Birth Environment|The intent is to surround the woman and her caregivers with specific types of auditory, visual, and tactile stim uli. One key feature of the ambient room is what is missing-the standard hospital bed. As an alternative, a portable double-sized mattress with several large pillows is set up in a corner of the room. The intent is to allow the woman freedom in positioning and to permit close contact with support people, and to limit the routine use of continuous elec tronic fetal heart rate monitoring and other technologies during normal labor. Lighting is dimmed. A wide variety of music selections are also available.
15746528|NCT04888000|Other|Educational Intervention|Professional development program provided to small groups of health care professionals in three different sessions over a period of one month with additional independent individual work to be completed between sessions.
15746529|NCT04887987|Radiation|strengthening training and LED PBMT|Participants will be submitted to a supervised 16-wk training program (3 d/week) involving a specific lumbar extension exercise on the Roman bench and four complementary exercises to improve core strength and spine stabilization. Participants will receive LED PBMT 30 minutes before each training session, through a device containing 264 LEDs, which will be placed on the lumbar region (between L1 and L5).
15746530|NCT04887987|Radiation|strengthening training and placebo PBMT|Participants will be submitted to a supervised 16-wk training program (3 d/week) involving a specific lumbar extension exercise on the Roman bench and four complementary exercises to improve core strength and spine stabilization. Participants will receive placebo PBMT 30 minutes before each training session, through a off-line device (turned off) containing 264 LEDs, which will be placed on the lumbar region (between L1 and L5).
15746531|NCT04887974|Procedure|canine retraction|Canine retraction using elastomeric chains activated every 4 weeks, using power arms to direct force through the center of resistance and TADs for direct anchorage.
15746532|NCT04887961|Drug|PLD and Trabectedin rechallenge|Platinum partially sensitive patients i.e. patients who recur with a platinum free interval between 6 and 12 months, who have previously received pegylated liposomal doxorubicin and are suitable for rechallenge with pegylated liposomal doxorubicin (PLD) with the combination of trabectedin (Yondelis®) and relapsed ovarian cancer fully platinum sensitive patients not able to receive or not willing to receive other platinum treatments
15746533|NCT04887948|Biological|20-valent pneumococcal conjugate vaccine (20vPnC)|20-valent pneumococcal conjugate vaccine (20vPnC)
15746534|NCT04887948|Biological|BNT162b2|RNA-based SARS-CoV-2 vaccine (BNT162b2)
15746535|NCT04887948|Other|Saline|Normal saline for injection
15746536|NCT04887935|Drug|Dapagliflozin|-The 10 mg dose is reflective of current clinical practice for diabetes and heart failure
15746537|NCT04887922|Device|MIR Spirobank G|FDA-approved, Bluetooth digital spirometer
15746538|NCT04887922|Device|ZEPHYRx®|ZEPHYRx® has developed a 1) digital Bluetooth-enabled IS that allows for the continuous and objective remote monitoring of patient compliance with pre- and postoperative IS via a smartphone app and online provider dashboard.
15746542|NCT04887883|Behavioral|Resistance exercise|Participants performed 8 weeks of resistance training and muscle biopsies were taken before and 24 h before and after the program.
15746543|NCT04887870|Drug|Sitravatinib|Sitravatinib is a small molecule inhibitor of recepor tyrosine kinases.
15746544|NCT04887870|Drug|Nivolumab|Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
15746545|NCT04887870|Drug|Pembrolizumab|Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody
15746546|NCT04887870|Drug|Enfortumab Vedotin-Ejfv|Enfortumab is a Nectin-4 directed antibody-drug conjugate (ADC) comprised of a monoclonal antibody conjugated to the small molecule microtubule disrupting agent, monomethyl auristatin E (MMAE)
15746547|NCT04887870|Drug|Ipilimumab|Ipilimumab is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody
15746548|NCT04887857|Drug|CC-486|CC-486 (oral azaciditine) 200 mg or 300 mg will be given orally (PO) once daily (QD) for 14 (or 21) days in a 28-day cycle.
15746549|NCT04887857|Drug|Venetoclax|Venetoclax 400 mg is administered PO QD on Days 1 to 28 per 28-day cycle. A brief dose ramp-up occurs for Cycle 1 with 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Day 3 and beyond.
15746550|NCT04887844|Drug|Lidocaine injection|Lidocaine injection were applied to the most tender point in the pes anserine region by means of the soft tissue infiltration technique only once at the commencement of the treatment period. All injections were performed by the same physician.
15746551|NCT04887844|Drug|Corticosteroid injection|Corticosteroid injection were applied to the most tender point in the pes anserine region by means of the soft tissue infiltration technique only once at the commencement of the treatment period. All injections were performed by the same physician.
15746552|NCT04887844|Other|Conventional Physical therapy|The study participants underwent a physiotherapy program that included a one-time 15-minute cold therapy using ice packs and closed-kinetic chain quadriceps strengthening program as follows; isometric quadriceps exercise, isokinetic concentric, and eccentric quadriceps exercises with heel slides and squads. These exercises were repeated ten times a day, seven days per week, for eight weeks in total
15746558|NCT04887818|Drug|2% Diltiazem ointment with 1.5% lidocaine|3 g of topical 2% diltiazem ointment with 1.5 % lidocaine applied in the perianal region circumferential q12h x 12 weeks
15746559|NCT04887818|Drug|0.3% Nifedipine ointment with 1.5% lidocaine|3 g of topical 0.3% nifedipine ointment with 1.5 % lidocaine applied in the perianal region circumferential q12h x 12 weeks
15746560|NCT04887805|Drug|Lenvatinib Mesylate|Given PO
15746561|NCT04887805|Biological|Pembrolizumab|Given IV
15746562|NCT04887792|Drug|Acetazolamide|ACZ 250 mg/day in gelatin capsules will be administered initially and increased over 7-10 days to 2g/day.
15746563|NCT04887792|Drug|Placebo|Identical gelatin capsules will be prepared by filling with inert excipients.
15746564|NCT04887779|Behavioral|Pathologist intervention|viewing explanted organ and microscopy
15746565|NCT04887766|Device|GS300|Gelesis300 hydrogel in gelatin capsules
15746566|NCT04887766|Device|Placebo|Placebo capsules
15746567|NCT04887753|Other|Synchronisation abilities|The study contains 1 descriptive and 3 experimental sessions. In the descriptive session, participant's clinical motor and cognitive functions are collected. In the first experimental session, participant's beat perception and synchronisation abilities is examined within a finger tapping paradigm. In the following experimental sessions participants synchronsiation abilities is examined during walking paradigms, to music and metronomes, with period and phase auditory manipulations.
15746568|NCT04887727|Dietary Supplement|Crystalline amino acids to assess myofibrillar protein synthesis rates|Amino acid dose = 0.25g/kg bodyweight
15746569|NCT04887727|Dietary Supplement|Crystalline amino acids to assess whole-body protein turnover, amino acid oxidation, and net protein balance|Amino acid dose = 0.25g/kg bodyweight
15746570|NCT04887714|Other|Mask|Mask wearing
15746572|NCT04887675|Diagnostic Test|MRI|Both groups with undergo neuroimaging on 3T magnetic resonance unit (Trio Tim, Siemens, Erlangen, Germany) in the Center for Diagnostic Imaging, Oncology Institute of Vojvodina, Serbia. Multivoxel MRS will be performed in the supratentorial cerebral parenchyma, covering white matter of frontal and parietal lobes, as well as cortical grey matter in frontal and parietal lobes and the whole cingulate gyrus.
15746573|NCT04887662|Other|Fermented vegetable|Participants will be asked to consume 100 g of fermented vegetables per day, at least 5 days per week, for 8 weeks
15746574|NCT04887649|Drug|Morphine|morphine 3 mg
15746575|NCT04887649|Drug|saline solution|4 cc of saline solution in epidural cateter in postpartum
15746576|NCT04887649|Drug|Morphine|morphine 2 mg for epidural cateter in postpartum
15746577|NCT04887610|Procedure|Ischemic preconditioning|Four 5-minute cycles of 200 mmHg cuff inflation of the brachial artery, each separated by 5-minutes deflated recovery (i.e. 40 minutes total time)
15746578|NCT04887610|Procedure|Ischemic preconditioning control|Four 5-minute cycles of 20 mmHg cuff inflation of the brachial artery, each separated by 5-minutes deflated recovery (i.e. 40 minutes total time)
15746579|NCT04887610|Dietary Supplement|High fat meal|Meal containing 1000 calories, 6 g fat, 1.5 g saturated fat, 0 g trans fat, 0 mg cholesterol, 187 g carbohydrates, 47 g protein, 450 mg sodium
15746580|NCT04887610|Dietary Supplement|Low fat meal|Meal containing 1030 calories, 60 g fat, 23 g saturated fat, 0.5 g trans fat, 450 mg cholesterol, 79 g carbohydrates, 41 g protein, 2,050 mg sodium.
15746581|NCT04887597|Drug|Secukinumab|The study is composed of a single arm receiving secukinumab for the duration of 6 months.
15746582|NCT04887584|Other|Control diet|The control Typical American Diet (TAD) diet pattern will mimic the level of intake of fruits, vegetables, whole grains, added sugars, saturated fats and sodium in the general U.S. population. This diet will feature no servings of pulses per day.
15746583|NCT04887584|Other|Low Pulse diet|The Low Pulse diet will be designed based on the TAD with substitution of pulses for lean meat and grains. This diet will feature 0.2 cups of pulses per day at 2,000 kilocalories (kcals).
15746584|NCT04887584|Other|High Pulse diet|The High Pulse diet will be designed based on the TAD with substitution of pulses for lean meat and grains. This diet will feature 1.5 cups of pulses per day at 2,000 kilocalories (kcals).
15746585|NCT04887571|Other|No Intervention - Observational Registry|All consecutive adult patients in the Cape Metropole and the Garden Route Health District with an Acute coronary syndrome (STEMI, NSTEMI, Unstable Angina) will be recruited into the PERFUSION Registry.
15746586|NCT04887558|Combination Product|Smart-T Mental Health and NRT|Smart-Treatment Mental Health App and Nicotine Replacement Therapy
15746587|NCT04887558|Combination Product|Smart-T Mental Health+ and NRT|Smart-Treatment Mental Health App+NRT adherence messages and Nicotine Replacement Therapy
15746588|NCT04887558|Combination Product|QuitGuide + NRT|NCI QuitGuide Treatment App and Nicotine Replacement Therapy
15746589|NCT04887545|Diagnostic Test|Proteomics analysis of pleural effusion|Pleural effusion removed as part of standard care is fractionized and analyzed by mass spectrometry
15746590|NCT04887532|Drug|HR19042 capsule|phase 1 :8mg; phase 2:12mg; phase 3:16mg
15746591|NCT04887519|Other|No Intervention|This is a non-interventional study.
15746595|NCT04887493|Drug|Misoprostol|Misoprostol 25µg will be used for both the study arms
15746596|NCT04887480|Device|Abthera™ Open Abdomen Negative Pressure Therapy Device System|Suction set at -125mmHg
15746597|NCT04887480|Drug|Dianeal PD-2 with 2.5% Dextrose|800mL to 1000mL of Dianeal PD-2 into Abthera™ and dwell for 1 hour.
15746598|NCT04887467|Drug|Apomorphine|"Assigned Interventions:
~blood sampling
~blood collection
~systolic, diastolic, mean blood pressure and heart rate measure"
15746599|NCT04887454|Behavioral|Once-Weekly HIIT|Participants in this group will receive a 16-week intervention of HIIT once weekly supervised by certified athletic coaches. Participants will perform four 4-minute intervals at 85%-95% peak heart rate with a 3-minute active recovery between each 4-minute interval. Participants will repeat the 25-minute HIIT bout three times with 30-60 minutes break in between each 25-minute HIIT bout. Health information provided to the usual care control group will be made available to the participants in the HIIT groups.
15746600|NCT04887454|Behavioral|Thrice-Weekly HIIT|Participants in this group will receive a 16-week intervention of HIIT thrice weekly supervised by certified athletic coaches. Participants will perform four 4-minute intervals at 85%-95% peak heart rate with a 3-minute active recovery between each 4-minute interval. Health information provided to the usual care control group will be made available to the participants in the HIIT groups.
15746601|NCT04887454|Other|Usual Care|Participants in the usual care control group will receive health education delivered by research personnel. This program will consist of eight two-hour bi-weekly sessions covering major health issues relating to obesity including causes, prevalence, epidemiology, associated diseases, healthy diet, caloric restriction advice, physical activity, stress management, adequate sleep, as well as lifestyle counseling/consultation and goal-setting/record-keeping strategies for behavioral changes.
15746602|NCT04887415|Device|Respiratory strength training|Devices will be set to 70% of participants' maximum expiratory pressure and maximum inspiratory pressure. Participants will complete training 5 days per week by performing 5 sets of 5 repetitions for both expiratory and inspiratory muscle strength training (a total of 50 repetitions).
15746603|NCT04887402|Drug|Clomiphene Citrate|"All patients will be treated with CC starting with 50 mg/day on the day 2 of their cycle for 5 days, a transvaginal ultrasound will be done 1 week after the last pill, if all follicles are below 10 mm the dose will subsequently be increased to 100mg/day for 5 days then 150mg/day for 5 days if a transvaginal is done a week from the last pill and showed no response (all follicles being below 10 mm ).Maximum cc dose will be 150 mg (ASRM, 2013). Medroxyprogesterone (10 mg/d Provera for 10 days)will be given to induce withdrawal bleeding to start these steps again in a new cycle. These steps will be repeated for 3cycles before declaring the patient CC resistant.
~o Response: Response to CC will be assessed by ovulation. TVS will be done by the same observer using a Samsung ultrasound machine, HS40.
~A scan will be done 1 week after the last pill of each dose. No response: if all follicles are below 10 mm (ASRM, 2013), follicles >10mm, follow up till ovulation"
15746604|NCT04887389|Drug|Nano Silver Fluoride varnish|Nano Silver Fluoride(5%) is a new experimental formulation containing silver nanoparticles, chitosan and fluoride combines preventive and antimicrobial properties. It is a yellow solution and safe to be used in humans
15746605|NCT04887389|Drug|nano-hydroxyapatite varnish|nano-hydroxyapatite (10%) has antibacterial effect, higher solubility, surface energy and bioactivity and its structure is similar to dental apatite.
15746606|NCT04887389|Drug|sodium Fluoride Varnish|Fluoride varnish (5%) applied every six months is effective in preventing caries in the primary and permanent dentition of children and adolescents
15746607|NCT04887376|Device|Mirror frame|Combined Mirror and NMES therapy
15746608|NCT04887376|Device|Control|Only NMES therapy
15746609|NCT04887363|Behavioral|Core exercise|Participants will receive12-week, 60 minutes, 36-session exercise-based core stability training class. Participants need complete baseline assessments of muscle performance, and balance ability measures 1 week prior and 1 week and 12 weeks following the intervention. All subjects will receive two post-exercise measurements at 13th week and 25th week.
15746610|NCT04887363|Behavioral|Tai Chi exercise|Participants will receive 12-week, 60 minutes, 36-session Tai Chi exercise training class. Participants need complete baseline assessments of muscle performance, and balance ability measures 1 week prior and 1 week and 12 weeks following the intervention. All subjects will receive two post-exercise measurements at 13th week and 25th week.
15746639|NCT04887142|Other|Standard of health care|The patients in this observational study will be exposed to the standard health care interventions according to the hospital diagnostic and treatment protocols and procedures and clinical judgment of the treating physicians.
15746667|NCT04886882|Other|sham comparator|vaseline, beeswax,polyglyceryl-3 diisostearate, sorbitan caprylate, propandiol,benzoic acid, glycerin, water
15746611|NCT04887350|Behavioral|Student-Senior Isolation Prevention Partnership (SSIPP)|The Student-Senior Isolation Prevention Partnership partners medical students with older adults in the community to provide social support and connection through regular phone calls. The goal of SSIPP is to reduce rates of anxiety, depression, and loneliness, while fostering resilience among seniors in our communities. This intervention will be delivered by phone to study participants once a week for a 30-60 minute session over a 12-week period.
15746612|NCT04887350|Behavioral|Problem Solving Therapy (PST).|Problem Solving Therapy is a psychotherapeutic intervention that teaches community members to identify and clarify problems at hand, set clear, achievable goals, brain-storm solutions to the problem, select their preferred solution, implement this solution, and evaluate the outcomes. This intervention will be delivered by a trained healthcare professional by phone to study participants once a week for a 30-60 minute session over a 12-week period.
15746613|NCT04887337|Procedure|Arthroscopic stabilization|Early arthroscopic stabilization with Bankart repair
15746614|NCT04887337|Other|Rehabilitation including a period of immobilization followed by physical therapy|Rehabilitation including a period of immobilization followed by physical therapy
15746615|NCT04887324|Other|no intervention|no intervention
15746616|NCT04887311|Drug|MBM-01|Patients will be administered study drug daily for 9 months QD via premarked medicine cups.
15746617|NCT04887298|Drug|Liposomal Annamycin (L-Annamycin)|2-hour intravenous (IV) infusion of L-Annamycin on Day 1 followed by 20 days off of study drug (i.e., 1 treatment cycle= 21 days)
15746618|NCT04887285|Device|Virtual reality|Subjects in the virtual reality group will be offered a variety of immersive environments to choose from (mountains, beach, rainforest and temperate forest) in addition to local anesthetic.
15746619|NCT04887285|Drug|Intravenous sedation|Sedation will be administered using low-dose midazolam and/ or fentanyl. We will use a wide range of dosing (1-5 mg for midazolam, up to 150 mcg for fentanyl) to maximize generalizability and account for widespread variability in clinical circumstances, medical practice and patient response (personalized medicine). Sedation will be titrated to effect by a board-certified or eligible anesthesiologist so that patients remain responsive to verbal stimuli.
15746620|NCT04887285|Other|Standard care|Patients will receive superficial local anesthetic with 1% lidocaine. Local anesthetic will be administered by the physician performing the procedure titrated to patient comfort.
15746621|NCT04887272|Other|Supervised Exercise Training Protocol|EXT: Supervised EXT will include a progressive individualized program that combines aerobic and resistance protocols. Volume progression will begin with 3-days of supervised training sessions/wk and will increase by 1 session/wk to a maximum of 5-days/wk. Each EXT session will include 30 minutes of aerobic training (15 minutes cycling; 15 minutes treadmill walking/running/elliptical) and 30 minutes of resistance training (specifics below). Considering individual fatigue will be a concern, therefore similar to exercise training standards in COPD, the duration of rest periods may be extended (~1-3 min) as needed, however, all exercise durations will be completed within a 1.5-hour time slot. On days that EXT and IMET interventions overlap, the training and IMET will be spread out over a 2-hour session as opposed to the 1.5-hour time slot.
15746622|NCT04887272|Other|Inspiratory Muscle and Exercise Training|Inspiratory Muscle Training (IMT): All IMT sessions will be performed similar to EXT, with the exception of having 2-3-sessions of at-home IMT training depending on where in the exercise progression the individual is (i.e., Week1 vs week 6). On the days that IMT and exercise training overlap, all training will be spread out over a 2-hour session with periods of IMT training occurring at the beginning, middle and end of the session. Each week will include a measure of Maximal Inspiratory Pressure (MIP) and a Test of Inspiratory Respiratory Endurance (TIRE). The intensity of the IMT will be 50% of the weekly MIP, thus progressive increases in IMT threshold intensity will remain at 50% of the weekly MIP. In contrast, the TIRE protocol will assess respiratory endurance based on the relative baseline intensity. Thus TIRE testing will begin at a MIP intensity of 50% (weeks 1-2), and then progressing to 65% (weeks 3-4), and 80% (weeks 5-6).
15746623|NCT04887259|Biological|LAVA-051|"In part 1 (dose escalation) LAVA-051 will be administered via intravenous infusion.
~In part 2 (dose expansion) LAVA-051 will be administered at the recommended phase 2 dose(s) and interval(s)"
15746624|NCT04887246|Biological|COVID-19 vaccines|COVID-19 vaccines available at Colombia
15746625|NCT04887233|Other|Longan nasal spray|The patients will be received 2 puff of Longan nasal spray 2 times/day for 3 days.
15746626|NCT04887233|Other|Placebo|The patients will be received 2 puff of placebo nasal spray 2 times/day for 3 days.
15746627|NCT04887194|Drug|Sitravatinib|Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases
15746628|NCT04887194|Drug|Warfarin|CYP2C9 probe substrate
15746629|NCT04887194|Drug|Dextromethorphan|CYP2D6 probe substrate
15746630|NCT04887194|Drug|Midazolam|CYP3A4 probe substrate
15746631|NCT04887194|Drug|Digoxin|P-gp probe substrate
15746632|NCT04887194|Drug|Rosuvastatin|BCRP probe substrate
15746633|NCT04887194|Drug|Nivolumab|Nivolumab is a programmed death receptor (PD-1) blocking antibody
15746634|NCT04887181|Other|Teethmate Desensitizer|Powder and liquid contained in the material were mixed. It was applied to the buccal surface of the sensitive tooth. then it was washed away from the tooth surface. 1-4 sessions were applied until the sensitivity disappeared.
15746635|NCT04887181|Other|Gluma Desensitizer|The material was applied to the buccal surface of the tooth with sensitivity. It was washed with water and removed from the tooth surface. 1-4 sessions were applied until the sensitivity disappeared.
15746636|NCT04887181|Other|Hybrid Bond|It was applied to the buccal surface of the sensitive tooth with an applicator. It was cured with a LED light device. Dentin sensitivity was checked with evaporative air application. The process was repeated until the sensitivity disappeared.
15746637|NCT04887168|Behavioral|Survive & Thrive|Psychoeducational Intervention: Survive & Thrive (Ferguson, 2008; Mahoney et al, 2018). A total of 10 manualised sessions of approximately 1.5 hour duration are offered. Individual sessions run using an educational format and in an informal setting, with a strong emphasis on avoiding individual disclosures. Groups will be delivered utilising a multi-disciplinary work force consisting of mental health staff in a ratio of 2 per group. Groups will consist of a maximum of 8-10 participants
15746638|NCT04887155|Behavioral|Cognitive behavioral therapy (CBT)|Group-based transdiagnostic cognitive-behavioral treatment
15746666|NCT04886882|Other|placebo comparator|solution containing 0.9 % sodium chlorine
15746640|NCT04887129|Diagnostic Test|COVID-19 RT-PCR test|"Participating individuals (students and employees) will be tested for COVID-19 (RT-PCR) using a specimen collected using a mid-turbinate swab.
~This asymptomatic testing regime starts on or after (if scheduling testing requires this to begin on a different day) enrollment and is repeated every 5-14 days for up to 16 months . Anyone testing positive is followed up as described below for symptomatic individuals.
~Those presenting with symptoms will be also tested for COVID-19 (RT-PCR). Those with negative test results will return to the asymptomatic testing protocol.
~Students who test positive are retested then 3 days until two negative tests. Employees who test positive also be tested every 3 days until two negative tests."
15746641|NCT04887129|Other|COVID-19 Vaccine Education Campaign|Utilizing information from focus groups, the investigators will develop and deploy an educational campaign aimed at improving vaccine hesitancy and student health
15746642|NCT04887116|Behavioral|Virtual Reality Exposure Therapy|Ten ninety minute sessions of Virtual Reality Exposure Therapy twice a week for five weeks
15746643|NCT04887103|Other|Hot water application|Pregnant women will apply hot water to their legs before going to sleep for a week.
15746644|NCT04887090|Device|Acupuncture and Drug Compound Technology|Before operation: The points of the meridian: Hegu, Neiguan, Chize, Zusanli, both sides are taken. TEAS (transcutaneous electrical acupoints stimulation) was performed every day for three days before the operation, using the Han's acupoint nerve stimulator to adjust the density and density waveforms at a frequency of 2/100 Hz (Hz). Current intensity is 10mA, and all acupuncture points are continuously stimulated for 30 minutes. During the operation: take the acupoints Hegu, Neiguan, Houxi, and Zhigou on both sides and give TEAS 30 minutes before induction of anesthesia. The stimulation intensity and frequency are the same as those before the operation until the end of the operation. Postoperative: Take the acupoints Chize, Waiguan, Taichong, and Yanglingquan, and take both sides. TEAS will be performed every 12 hours from the first day after surgery. Each treatment is 30 minutes until 48 hours after surgery. The intensity and frequency are the same as before surgery.
15746645|NCT04887090|Other|Routine perioperative management|Comprehensive evaluation of cardiopulmonary function, preparation of respiratory tract, active treatment of coexisting diseases before operation, correction of water and electrolyte disorders and hypoproteinemia before operation. To prevent cross-infection during the operation, the intraoperative blood volume should be supplemented within the tolerance of cardiac function, the tissue perfusion should be sufficient, and the infusion should be uniform. Strengthen respiratory care after operation, prevent cardiovascular complications, pay attention to the speed and amount of blood transfusion, encourage early activities, promote lung expansion and prevent thrombophlebitis.
15746646|NCT04887077|Device|Kiplin|"The Kiplin intervention will be composed of four components within a smartphone application: a) a gamification of Physical Activity through multiple games called animations, b) a remote adapted physical activity program with telecoaching sessions, c) an interface for exchange and conversation and, d) an activity monitoring tool."
15746647|NCT04887077|Behavioral|face-to-face|three-month program of face-to-face adapted physical activity, three sessions a week, for a total of 36 sessions.
15746648|NCT04887064|Drug|Sotorasib|Sotorasib will be administered as an oral tablet.
15746649|NCT04887051|Other|pulmonory based home exercises|web based telerehablitation
15746650|NCT04887038|Drug|SRT-015|Each study part (A,B and C) will be completed sequentially, but with partial overlapping. The first cohort of Part B (Cohort B1) may be initiated after safety, tolerability and available PK data are assessed and deemed suitable to continue for a single dose on Part A that is equal to or greater than the total exposure of cohort B1. Part C (Cohort C1 & C2) may be initiated after safety, tolerability and PK data are assessed and deemed suitable to continue for a single dose in part A that is at least double the specified dose from part C.
15746651|NCT04887038|Other|Matching Placebo for SRT-015|Matching Placebo
15746652|NCT04887025|Biological|RGV004|a genetically-engineered vaccinia virus (encoding CD19/CD3 bispecific antibody)
15746653|NCT04887012|Biological|anti-CD19 CAR-NK|lentiviral vector-transducted HLA haploidentical NK cells to express anti-CD19 CAR
15746654|NCT04886999|Behavioral|Exploratory study on patient's perception of Asthma symptoms|To assess the perception of symptoms and the psychopharmacological aspects in patients with moderate to severe asthma comparing two inhalers of CHF1535 100/6 µg pMDI
15746655|NCT04886986|Drug|225Ac-J591|30 - 40 KBq/kg (dose-escalation) every 8 weeks, for up to 2 cycles. Administered together with 177Lu-PSMA-I&T. Intravenous administration.
15746656|NCT04886986|Drug|177Lu-PSMA-I&T|6.8 GBq (fixed dose) every 8 weeks, for up to 2 cycles. Administered together with 225Ac-J591. Intravenous administration.
15746657|NCT04886986|Drug|68Ga-PSMA-11|[185 ±74 MBq or 5 ±2 mCi] intravenous during screening, 12 weeks, 24 weeks. Imaging agent for PSMA PET/CT.
15746658|NCT04886973|Other|Administration of an 8% crystalline L-amino acid solution with high concentrations of branched chain amino acids.|Intravenous administration of 8% crystalline L-amino acids with high concentrations of branched chain amino acids.
15746659|NCT04886960|Biological|Amniotic Fluid Injection|Comparison of Standard of Care (Corticosteroid) injection vs. Sterile Processed Amniotic Fluid Injection for Knee Osteoarthritis
15746660|NCT04886960|Other|Standard of Care|Comparison of Standard of Care (Corticosteroid) injection vs. Sterile Processed Amniotic Fluid Injection for Knee Osteoarthritis
15746661|NCT04886947|Procedure|stem cell transplantation|After surgical repair of alveolar cleft using gingivoperiosteoplasty, processed and stored autologous stem cells will be added at the repair site. After which the patient will be followed up for bone regeneration and this will be compared to control where no stem cell is added.
15746662|NCT04886934|Device|CS1 System|Placement of CS1, a temporary bipolar myocardial electrode (TME) with an integrated motion sensor (accelerometer), on the left ventricle and externalization of the associated leads through the chest wall during open-heart surgery. CS1 will remain in place for up to 7 days after surgery and closure of the chest wall.
15746663|NCT04886921|Behavioral|Abdominal muscle training|Participants will receive 12-week, 60 minutes, 36-session abdominal muscle training in the TRAM women. Aimed to evaluate the effects on abdominal muscle functions after 12 weeks abdominal muscle training in the TRAM women. Outcome measures were the clinical tests for trunk muscle strength, endurance and one-leg standing was also used to exam the abdominal muscle function.
15746664|NCT04886908|Other|Data extraction from medical files|Data extraction from medical files
15746665|NCT04886895|Other|Let's Move|Motor intervention
15746668|NCT04886882|Other|Experimental drug 1|A cream containing 10 % MgSO4.vaseline, beeswaxpolyglyceryl-3 diisostearate, sorbitan caprylate, propandiol,benzoic acid, glycerin, water
15746669|NCT04886882|Other|Experimental drug 2|A cream containing 10 % MgSO4.vaseline, beeswax,polyglyceryl-3 diisostearate, sorbitan caprylate, propandiol,benzoic acid, glycerin, water
15746670|NCT04886882|Drug|Centella asiatica|A cream containing Centella asiatica
15746671|NCT04886869|Dietary Supplement|caffeine|oral consumption
15746674|NCT04886843|Other|Cold pack|Five minutes cold pack was applied on the affected side dorsiflexor muscle skin, a five-minute break was given and a further 5-minute cold application was repeated
15746675|NCT04886843|Device|NMES|NMES was applied to the nonaffected side ankle dorsiflexors
15746676|NCT04886830|Procedure|laparoscopic appendectomy using a single endoloop for appendiceal stump closure|laparoscopic appendectomy using a single endoloop for appendiceal stump closure before resecting the appendix
15746677|NCT04886830|Procedure|laparoscopic appendectomy using two endoloops for appendiceal stump closure|laparoscopic appendectomy using a two endoloops for appendiceal stump closure before resecting the appendix
15746678|NCT04886830|Procedure|laparoscopic appendectomy using a clip for appendiceal stump closure|laparoscopic appendectomy using an endoclip for appendiceal stump closure before resecting the appendix
15746679|NCT04886817|Behavioral|Pilot Intervention to reduce SSB consumption in children and families|"A 6-month intervention based on the use of 4 components: an educational video, provision of a water-promotion toolkit, a mobile phone application (app), and a series of 14 computerized interactive voice response (IVR) phone calls to parents to compare families' SSB's consumption behaviors"
15746680|NCT04886804|Drug|BI 1810631|BI 1810631
15746683|NCT04886778|Dietary Supplement|Low-carbohydrate diet|Participants will be instructed to maintain a daily dietary energy intake of less than 1600 kcal.Based on the low-carbohydrate diet model, the proportion of daily intake of carbohydrate was about 30%, and this ratio was up to 30%, 40% of protein and fat respectively.Participants should choose unprocessed whole grains, potatoes, vegetables, meat, fish, eggs, soy products, sugar-free dairy products, designated varieties of low-GI fruits and nuts, etc. as breakfast, and avoid processed meats and high-fat red meat and poultry skins. Standard nutritious meal instead of daily lunch and dinner meals, that is to say, participants should take one nutritional bar for lunch and dinner (310 kcal totally, provided by Guangzhou Nanda Fett Nutrition and Health Consulting Co., Ltd.), and avoid starchy foods. Other food varieties are required to be the same as breakfast. Plant oil is the main cooking oil, and participants will be instructed to drink 2L water every day.
15746684|NCT04886778|Dietary Supplement|Probiotic compound preparations|The probiotic compound preparation，named Junyi Yili® Probiotics，is made of Lactobacillus reuteri, Lactobacillus gasseri, Lactobacillus acidophilus and Bifidobacterium lactis, and resistant dextrin contained water-soluble dietary fiber. The subjects will take this probiotic compound preparations with purified water after three meals every day, 1 sachet each time.
15746685|NCT04886778|Dietary Supplement|Placebo|Placebo is made of resistant dextrin which contained water-soluble dietary fiber. The subjects were taken this placebo with purified water after three meals every day, 1 sachet each time.
15746686|NCT04886765|Drug|ALMB-0168|ALMB-0168 will be administered intravenously until either the disease progresses or intolerable toxicity occurs.
15746687|NCT04886752|Dietary Supplement|vitamin C without liposome|subjects need to take 3 tests during trail. After each test was completed, a washout period of 14 days was required before the next test start
15746688|NCT04886752|Dietary Supplement|liposomal process A vitamin C|subjects need to take 3 tests during trail. After each test was completed, a washout period of 14 days was required before the next test start
15746689|NCT04886752|Dietary Supplement|liposomal process B vitamin C (Double Nutri™)|subjects need to take 3 tests during trail. After each test was completed, a washout period of 14 days was required before the next test start
15746690|NCT04886739|Drug|CGB-400|Topical gel
15746691|NCT04886739|Drug|Vehicle Gel|Topical gel
15746692|NCT04886726|Drug|uhCG/EGF|PTCY for 2 doses on day +3 and +4 after stem cell transplant followed by uhCG/EGF subcutaneously on day +7, +9 and +11 post stem cell transplant
15746693|NCT04886713|Diagnostic Test|Adipose and myocardial tissue sampling|After median sternotomy tissue samples will be collected from the epicardial space, the abdominal wall and the myocardium.
15746694|NCT04886713|Diagnostic Test|Cardiac magnetic resonance imaging|"Magnetic resonance imaging will be performed at 1.5 Tesla ('Intera', Philips Medical Systems, Best, The Netherlands). All subjects will be examined in the supine position with initial anatomy scans to cover the thorax to the first sacral vertebrae. The magnetic resonance imaging protocol is summarized in Figure 4.
~The following imaging parameters will be acquired:
~Biventricular end-diastolic and end-systolic volume, ejection fraction, stroke volume
~Biventricular mass, wall thickness
~T1 mapping; native and > 10 minutes post contrast injection as an estimate of left ventricular diffuse fibrosis and extracellular volume
~Late enhancement for detection of regional fibrosis and scar
~Myocardial feature tracking for analysis of deformation/motion
~Epicardial fat volume"
15746695|NCT04886713|Diagnostic Test|Cardiopulmonary exercise testing|After completion of a regular cardiac rehabilitation program patients are scheduled to undergo their discharge examination at 3 to 4 weeks after the operation in order to be functionally characterized. Cardiopulmonary exercise testing will be performed, if possible by patients condition, on a mechanically braked bicycle ergometer and respiratory gas exchange analysis via a mouthpiece or facemask.
15746696|NCT04886700|Drug|SG001|Subjects will receive intravenous infusion of SG001 at the dose of 240 mg every 2 weeks until disease progression, unacceptable toxicity, meeting the suspension or termination criteria, or up to 24 months in patients without disease progression.
15746697|NCT04886687|Procedure|mechanical thrombectomy|mechanical thrombectomy
15747158|NCT04882800|Device|extended wear hearing aid A|extended wear technology with fitting modifications
15746698|NCT04886674|Dietary Supplement|bovine colostrum|The neonates will receive the colostrum in a dose of 2 g/dose for the 1000-1500 g stratum and 1.2 g/dose for < 1000 g stratum, four times a day until discharge or death or day 21 of life, whichever is earlier.
15746699|NCT04886661|Other|CHRONIC NECK PAIN|Demographic information will be collected. Neck Disability Index will be filled. Physical examination will be performed.
15746700|NCT04886648|Behavioral|Music Therapy|
15746701|NCT04886635|Other|Active surveillance|Patients will undergo two clinical response evaluations (CREs) after nCRT. During CRE-1 (5-6 weeks) patients will undergo oesophagogastroduodenoscopy (OGD) with bite-on-bite biopsies. During CRE-2 (10-12 weeks) patients will undergo positron emission tomography with computed tomography (PET-CT), endoscopy with bite-on-bite biopsies and endoscopic ultrasonography (EUS) plus fine-needle aspiration (FNA). If cancer is detected, surgery will be performed. Patients with cCR are eligible for active surveillance where regular CREs are performed to detect regrowth of cancer. Delayed oesophagectomy will be offered to patients with highly suspected or profen locoregional regrowth, without distant metastases. The safety and feasibility of active surveillance depends on several factors monitored in the SANO trial. So far, these stopping rules have not been met. In case one of the stopping rules is reached, further inclusion in the SANO-2 study will be stopped and surgical resection is offered.
15746702|NCT04886622|Drug|DT2216|DT2216 will be administered by intravenous infusion
15746703|NCT04886609|Device|ORISE gel|To establish if ORISE Gel an effective and feasible submucosal injecting solution during endoscopic resection of large colorectal polyps
15746704|NCT04886596|Biological|RSVPreF3 OA Lot 1|Lot 1 of the RSVPreF3 OA vaccine administered intramuscularly into the deltoid of the non-dominant arm at day 1 (Part 1)
15746705|NCT04886596|Biological|RSVPreF3 OA Lot 2|Lot 2 of the RSVPreF3 OA vaccine administered intramuscularly into the deltoid of the non-dominant arm at day 1 (Part 1)
15746706|NCT04886596|Biological|RSVPreF3 OA Lot 3|Lot 3 of the RSVPreF3 OA vaccine administered intramuscularly into the deltoid of the non-dominant arm at day 1 (Part 1)
15746707|NCT04886596|Biological|RSVPreF3 OA Lot 4|Lot 4 of the RSVPreF3 OA vaccine administered intramuscularly into the deltoid of the non-dominant arm at day 1 (Part 2)
15746708|NCT04886596|Drug|Placebo|Placebo administered intramuscularly into the deltoid of the non-dominant arm at day 1
15746709|NCT04886583|Device|Gabi Baby Band|Every enrolled patient must wear the Gaby Baby Band on the left arm in the aim to perform data analytics after the test has been performed
15746710|NCT04886570|Device|hip arthroplasty|Hip arthroplasty is a kind of joint reconstruction surgery, which has been successfully utilized for treatment of osteoarthritis or hip fracture for decades. In this surgery, implants is applied to reconstruct hip joint, and usually comprised of four components, including femoral stem, femoral head, acetabular cup and liner.
15746711|NCT04886557|Procedure|L4-L5 decompression and dynamic instrumentation|All surgeries were performed by a senior surgeon using a traditional midline approach. Stability-preserving lumbar decompression with facet joint undercutting was performed to preserve the facet joints as much as possible. In cases of severe stenosis, a bilateral partial facetectomy (< 25%) was performed for adequate decompression. Posterior tension of the supra- and inter-spinous ligaments was preserved at the most cranial level. Patients were encouraged to ambulate after drain removal and wear a soft lumbar orthosis for at least 3 months after the operation.
15746712|NCT04886544|Device|YVOIRE Y-Solution 720|Hyaluronic acid dermal filler
15746713|NCT04886531|Drug|Neratinib|120mg for 7 days; 160mg for 7 days ; 240mg for 7 days. 240 mg (up to a maximum of 24 weeks) orally daily*.
15746714|NCT04886531|Drug|Letrozole (L) or Anastrozole (A)|L: (2.5 mg) OR A: (1 mg) orally daily (up to a maximum of 24 weeks)*
15746715|NCT04886531|Drug|Trastuzumab|All Arms 8mg/kg loading dose followed by 6mg/kg every 3 weeks administered every 3 weeks by IV starting wk 4. Trastuzumab biosimilars may be used per institutional guidelines.
15746716|NCT04886518|Drug|Pitolisant Oral Tablet|"Pitolisant 4.45 mg tablets: white, round, plain, biconvex film-coated tablet, 3.7 mm in diameter. Each tablet contains 5 mg of pitolisant hydrochloride equivalent to 4.45 mg of pitolisant.
~Pitolisant 17.8 mg tablets: white, round, plain, biconvex film-coated tablet, 7.5 mm in diameter. Each tablet contains 20 mg of pitolisant hydrochloride equivalent to 17.8 mg of pitolisant"
15746717|NCT04886518|Drug|Placebo oral tablet|Matching placebo tablets will be provided for each strength of active pitolisant film-coated tablets.
15746718|NCT04886505|Device|Electrolytic eCLIPs Bifurcation System|The electrolytic eCLIPs bifurcation system will be implanted into patients with bifurcated saccular intra-cranial aneurysms.
15746719|NCT04886479|Device|Daily Disposable Silicone Hydrogel Contact Lens|Subjects will be randomized to wear Daily Disposable Silicone Hydrogel Contact Lens in one eye and will be patched for 3 hours with the contralateral eye remain open.
15746720|NCT04886479|Device|Daily Disposable Hydrogel Contact Lens|Subjects will be randomized to wear Daily Disposable Hydrogel Contact Lens in one eye and will be patched for 3 hours with the contralateral eye remain open.
15746721|NCT04886479|Other|Non Lens Wearers|Subjects with no previous history of contact lens wear
15746722|NCT04886466|Procedure|core stability in a sitting position and while walking in one place|The intervention consisted of checking how the active tension of the multisection and transverse abdominal muscles affects the pattern of the trunk movement (in the sitting position) and the work of the lower limbs and the speed of movement while walking in a place.
15746723|NCT04886453|Drug|Balanced general anesthesia without morphine|Balanced general anesthesia without morphine
15746724|NCT04886453|Drug|Standard general anesthesia balanced with morphine|Standard general anesthesia balanced with morphine
15746725|NCT04886453|Other|Data collection|Data collection
15746726|NCT04886453|Other|Assessment of pain|visual analog scale
15746727|NCT04886453|Other|Recovery quality score|QoR15 questionnaire
15746728|NCT04886427|Other|No intervention|Measure the experiences of the current care
15746729|NCT04886414|Other|Phone-based monitoring|Study staff will perform daily phone-based assessments using standardized electronic study tools (tablets). Clinical features will be documented on a phone-based patient monitoring form.
15746730|NCT04886414|Other|In-person monitoring|Study staff will perform daily in-person home-based assessments using standardized electronic study tools (tablets). Clinical features will be documented on an in-person patient monitoring form.
15746731|NCT04886414|Other|Oxygen saturation monitoring|Oxygen saturation will be monitored and recorded at regular intervals.
15746732|NCT04886414|Other|Alcohol-based hand sanitizer|Alcohol-based hand sanitizer will be distributed to subjects.
15746733|NCT04886388|Device|BT-001|BT-001 is a software program intended to help patients with type 2 diabetes, under the guidance of their physician, improve glycemic control.
15746734|NCT04886388|Other|Physician-guided Standard of Care for type 2 diabetes|Current ADA Standard of Care Guidelines for type 2 diabetes
15746735|NCT04886375|Procedure|erector spina plane block|The investigators performed erector spina plane block to that patient group for postoperative analgesia
15746736|NCT04886375|Procedure|modified pectoral nerve block|The investigators performed modified pectoral block to that patient group for postoperative analgesia
15746737|NCT04886362|Drug|Ivermectin|Treatment with Ivermectin in the first 7 days from symptoms onset.
15746738|NCT04886362|Drug|Placebo|Treatment with Placebo in the first 7 days from symptoms onset.
15746739|NCT04886349|Biological|Platelet-rich plasma|Platelet-rich plasma injection for first CMC OA
15746740|NCT04886323|Device|Cold atmospheric plasma treatment device|Treat with cold atmospheric plasma treatment device.
15746741|NCT04886323|Drug|2% ketoconazole cream|Treat with 2% ketoconazole cream.
15746742|NCT04886310|Diagnostic Test|Peabody Developmental Motor Scale II (PDMS-2)|is composed of six subtests (reflex, stationary, locomotion, object manipulation, grasping, and visual-motor integration) that measure inter-related abilities in early motor development. It was designed to assess gross and fine motor skills in children from birth through 5 years of age.
15746743|NCT04886297|Drug|Mega Resveratrol® capsules|Subjects were orally administered Mega Resveratrol® capsules daily for 8 weeks.
15746744|NCT04886297|Drug|Mega Resveratrol® Placebo capsules|Mega Resveratrol® Placebo capsules
15746745|NCT04886284|Drug|Ertapenem|Adjunctive ertapenem
15746746|NCT04886284|Drug|Placebo|Saline placebo
15746747|NCT04886271|Drug|HX009|Eligible participants will receive HX009 treatment at 5mg/Kg via IV infusion over 60-120 minutes, and the scheduled dosing cycle is once every 2 weeks.
15746750|NCT04886245|Other|Video sequences|"videos will be made of each participant, during the realization of 5 movements that are the simple closure of the eyelids, the forced closure of the eyelids, the labial protrusion on the sound [o], the labial protrusion on the sound [pu] and the wide smile uncovering the teeth.
~Then, a video sequence will be realized thanks to the dedicated software Tobii Pro Lab®."
15746754|NCT04886206|Biological|DLI|the patients will receive the injection of donor lymphocytes from haplo-identical donor (the son or daughter or possibly nephew or niece of the patient). No immunosuppressive drugs will be used. The HLI dose levels are 1) 1x107 CD3+/kg 2) 5x107 CD3+/kg 3) 7.5x107 CD3+/kg 4) 1x108 CD3+/kg.The CRM method (Continual Reassessment Method) was chosen to specify the dose of cells to be injected, each patient being assigned a dose that is believed to be associated with the target toxicity corresponding to the maximum tolerated dose (MTD). The dose-toxicity curve will be readjusted after assessing the toxicity of each patient.
15746755|NCT04886193|Drug|FLOT(Docetaxel+oxaliplatin+leucovorin+5-FU), Treprizumab, Tiggio capsule (S-1)|"FLOT: Docetaxel 50mg/m2 ivd d1 + oxaliplatin 85mg/m2 ivd d1 + leucovorin 200mg/m2 ivd d1 + 5-FU 2600mg/m2 civ 24h Q2W
~Treprizumab 3mg/kg, intravenously administered on the first day of each cycle, Q2W
~Tiggio capsule (S-1) 40-60mg (BSA<1.25 m2: 40mg, 1.25 m2≤BSA≤1.5 m2: 50mg, BSA> 1.5 m2: 60mg) po bid d1-14 Q3W, continuous treatment for 1 year;
~Teriprizumab 240mg, intravenously, given on the first day of each cycle, Q3W, continuous treatment for 1 year."
15746756|NCT04886180|Device|Oxiris membrane|Hemofiltration treatment with Oxiris membrane connected to the ECLS circuit for 24 hours.
15746757|NCT04886180|Device|Prismaflex membrane|Treatment by hemofiltration with PrismaFlex ST150 membrane connected to the ECLS circuit for 24 hours.
15746758|NCT04886180|Biological|Blood tests|Blood tests before and just after membrane placement and at H6, H24, H48 and H72 after membrane placement
15746759|NCT04886167|Drug|AbobotulinumtoxinA|Injection of platysmal bands.
15746765|NCT04886141|Behavioral|Virtual Reality Headset|To determine if virtual reality headsets can reduce a patients pain level instead of using the standard Nitrous. This may provide a alternate to patients who cannot receive nitrous if pain or anxiety can be reduced effectively.
15746766|NCT04886115|Other|Neuromuscular evaluation|"Before and after training.
~Muscle function:
~voluntary maximal isometric force of the knee extensors
~evoked force in the knee extensors by double percutaneous electrical stimulation at 100 and 10 Hz
~level of voluntary activation
~voluntary maximum force in concentric and eccentric mode at an angular speed of 60°.s-1
~squat jump and counter-movement jump"
15746767|NCT04886115|Other|Assessment of aerobic capacity, muscle architecture and habituation to the eccentric pedaling task|"Before and after training.
~Cardiovascular-respiratory function:
~Oxygen consumption during the incremental concentric pedaling test conducted to high effort perception.
~heart rate during pedaling tasks
~Muscle architecture:
~- Pennation angle and thickness of vastus lateralis, rectus femoris, gastrocnemius medialis and lateralis muscles, before and after training.
~Familiarization with eccentric pedaling"
15746768|NCT04886115|Other|Pedaling at 15 rpm|3 training sessions per week for 6 weeks
15746769|NCT04886115|Other|No pedaling, usual activity|Maintain usual physical activity and diet for a period of 6 weeks.
15746770|NCT04886115|Other|Pedaling at 60rpm|3 sessions per week of training for 6 weeks
15746771|NCT04886102|Other|An additional 5 mL venous blood tube taken from patients during their routine medical check-up at the hospital|Research protocol involving the human person (Category 3 - Non-interventional research_ not related to a health product) Serology, molecular biology, phylogenetic and phylodynamic analyzes of hepatitis B and D
15746772|NCT04886089|Device|Pleth variability index for prediction of post-induction hypotension|The use of the baseline Pleth variability index values for prediction of occurrence of post-induction hypotension
15746773|NCT04886063|Drug|ATH-1017|Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe
15746774|NCT04886050|Drug|LC350189 Tablet|Subject will receive an LC350189 Tablet as single dose on Day 1 or Day 5
15746775|NCT04886050|Drug|LC350189 Capsule|Subject will receive an LC350189 Capsule as single dose on Day 1 or Day 5
15746776|NCT04886037|Other|sestrin|Serum sestrin levels involved in inflammation and energy metabolism are compared between endometriosis and healthy control group.
15746777|NCT04886024|Other|Advanced Glycation End Products (AGEs)|Advanced Glycation End Products (AGEs) releated with energy metabolism, In this study, the possible relationship between the serum levels of Advanced Glycation End Products (AGEs) of endometriosis patients and the disease and its stage is evaluated.
15746778|NCT04886011|Combination Product|placebo gel|just methyl cellulose gel was applied to the ulcer
15746779|NCT04886011|Combination Product|camel whey protein gel|camel whey protein gel was prepared and dissolved in methyl cellulose gel base and applied to the ulcer
15746780|NCT04885998|Drug|AMG 757|AMG 757 will be administered as an intravenous (IV) infusion.
15746781|NCT04885998|Drug|AMG 404|AMG 404 will be administered as an intravenous (IV) infusion.
15746782|NCT04885985|Device|DEB catheter|"Trade name of DEB catheter: AcoArt Tulip (0.018) or AcoArt Litos (0.014)"
15746783|NCT04885972|Drug|Resiniferatoxin|Resiniferatoxin is a compound purified from natural sources.
15746784|NCT04885972|Drug|Zilretta|Zilretta is an extended-release corticosteroid approved to manage osteoarthritis knee pain.
15746785|NCT04885972|Drug|Placebo|Vehicle solution
15746786|NCT04885959|Behavioral|Personalized Prevotella sp. and butyrate enriching diet guidelines|specially design dietary guidelines with biomarkers monitoring
15746787|NCT04885946|Other|Fecal microbiota transplantion (FMT)|Single donor, fecal microbiota transplantion (FMT) from healthy human donors.
15746788|NCT04885946|Other|Placebo|Food coloring, water, glycerol
15746789|NCT04885933|Diagnostic Test|sarcopenia measurement|BIA for fat free muscle mass hand grasp strength
15746790|NCT04885907|Biological|mRNA-1273 vaccine|COVID vaccine 3rd dose
15746791|NCT04885907|Other|Normal Saline Placebo|Normal Saline Placebo
15746792|NCT04885894|Drug|Zeposia|Participants with MS will be divided into two treatment groups: those who will begin to take Zeposia, and those who plan to be begin treatment with high dose oral efficacy medication. The HC group will be free of neurological disease or injury and will be matched to the MS groups for age, gender, and education.
15746793|NCT04885881|Procedure|Ozone therapy|Patients in the ozone therapy group will be treated with ozone (O2-O3) in a volume of 5 ml and a dose of 10 µg / ml for three consecutive weeks in a weekly session to the most painful trigger point.
15746794|NCT04885881|Procedure|Lidocaine injection group|Patients in the lidocaine injection group will be applied to the most painful trigger point in a volume of 2 ml of 1% lidocaine for three consecutive weeks, once a week.
15746795|NCT04885868|Other|This study assess acceptability of autonomous conversation as part of cataract surgery follow up.|This study assess acceptability of autonomous conversation as part of cataract surgery follow up.
15746796|NCT04885855|Drug|Sofosbuvir 400 MG|Sofosbuvir is a direct-acting antiviral (DAA) a nucleotide analog inhibitor of hepatitis C virus nonstructural protein 5B (NS5B)
15746797|NCT04885855|Drug|Ravidasvir 200mg|Ravidasvir is an investigational direct-acting antiviral (DAA) a nucleotide analog inhibitor of hepatitis C virus nonstructural protein 5A (NS5A)
15746798|NCT04885842|Other|injection I-PRF|injection I-PRF with brackets
15746799|NCT04885829|Drug|Tocilizumab Prefilled Syringe|0.9ml Subcutaneous pre-filled syringes containing 162mg of Tocilizumab.
15746802|NCT04885803|Dietary Supplement|Softgel Vitamin D3|5000IU vitamin D3 taken as single oral softgel once daily for 30 days
15746803|NCT04885803|Dietary Supplement|Nano Liquid Vitamin D3|5000IU vitamin D3 taken as liquid oral spray once daily for 30 days
15746804|NCT04885803|Diagnostic Test|25(OH)D Blood Serum Test|A sample of blood is drawn off and processed for 25(OH)D levels at baseline, after 15 days of supplementation, and after 30 days of supplementation
15746805|NCT04885803|Other|Placebo Control|Liquid oral spray once daily for 30 days. Solution identical in smell, taste, color, and production process to Nano Liquid D3, but containing no Vitamin D3.
15746810|NCT04885777|Drug|Lidocaine|"Initially, a nasopharyngeal swab was performed on each group without any intervention. Investigators waited at least one hour for the second sample collection. If the participant was still in pain or felt discomfort due to the first sampling, the waiting time has been extended.
~At the second stage, one ml of a solution containing 20 mg/ml of lidocaine, was applied to each nostril of the participants in the Lidocaine group. Thus, a total of 40 mg of lidocaine, 20 mg for each nostril, was given to the individuals of the Lidocaine group. The second samples were collected after waiting 5 minutes following the administration of the solution."
15746811|NCT04885777|Other|Placebo|"Initially, a nasopharyngeal swab was performed on placebo group without any intervention. Investigators waited at least one hour for the second sample collection. If the participant was still in pain or felt discomfort due to the first sampling, the waiting time has been extended.
~At the second stage, the Placebo group received only a total of 2 ml of 0.9% NaCl (one ml for each nostril). The second samples were collected after waiting 5 minutes following the administration of the solution."
15746812|NCT04885764|Biological|Astrazeneca/Oxford Vaccine|Viral non replicated vector vaccine contains the gene that encodes for the spike protein on the surface of the SARS-CoV-2 virus given Intramuscular injection in 2 doses 3 months apart
15746813|NCT04885764|Biological|Sinopharm vaccine|Inactivated vaccine given intramuscular injection in 2 doses 3 weeks apart
15746814|NCT04885751|Drug|Eupatilin|take eupatilin to prevent NSAID induced gastroenteropathy
15746815|NCT04885751|Drug|Rebamipide|take rebamipide to prevent NSAID induced gastroenteropathy
15746816|NCT04885738|Other|no intervention|"For Chronic Cough，follow《Guidelines for the diagnosis and treatment of cough》(2015).
~For Asthma, follow GINA For COPD, follow GOLD."
15746817|NCT04885725|Device|All group|All the participants performed the isokinetic proprioception and strength tests and the functional tests, on the same visit.
15746818|NCT04885712|Drug|Metformin≥1000mg|Subjects take the investigational products once a day for 24 weeks.
15746819|NCT04885712|Drug|Pioglitazone 15mg|Subjects take the investigational products once a day for 24 weeks.
15746820|NCT04885712|Drug|Pioglitazone 30 mg|Subjects take the investigational products once a day for 24 weeks.
15746821|NCT04885712|Drug|Pioglitazone 15mg Placebo|Subjects take the investigational products once a day for 24 weeks.
15746822|NCT04885712|Drug|Pioglitazone 30mg Placebo|Subjects take the investigational products once a day for 24 weeks.
15746823|NCT04885712|Drug|Dapagliflozin 10mg|Subjects take the investigational products once a day for 24 weeks.
15746824|NCT04885686|Device|Endomethasone N RCS|Root canal sealer
15746825|NCT04885686|Device|Endomethasone SP RCS|Root canal sealer
15746826|NCT04885673|Device|Vapotherm|flow rate 50 L/min with 100% humidified oxygen and the temperature adjusted to be 38℃
15746827|NCT04885673|Device|Apneic oxygenation|Standard apneic oxygenation through the side port of rigid bronchoscope during the procedure
15746828|NCT04885660|Drug|compound lisinopril tablet|The subjects randomly received single oral administration of compound lisinopril tablet(Lisinopril 10mg/Levamlodipine besylate 5mg)
15746829|NCT04885660|Drug|compound lisinopril tablet(Lisonorm®)|The subjects randomly received single oral administration of compound lisinopril tablet(Lisonorm®)
15746830|NCT04885647|Drug|YPEG-rhEPO|YPEG-rhEPO，low dose，were subcutaneous injected once every two weeks for 13 weeks.
15746831|NCT04885647|Drug|YPEG-rhEPO|YPEG-rhEPO，low dose，were subcutaneous injected once every four weeks for 13 weeks.
15746832|NCT04885647|Drug|YPEG-rhEPO|YPEG-rhEPO, high dose，were subcutaneous injected once every two weeks for 13 weeks.
15746833|NCT04885647|Drug|YPEG-rhEPO|YPEG-rhEPO，high dose，were subcutaneous injected once every four weeks for 13 weeks.
15746834|NCT04885634|Drug|Semaglutide Injectable Product|Subcutaneous injection of Semaglutide 2.4 mg once weekly
15746835|NCT04885634|Drug|Placebo|Subcutaneous injection of volume-matched placebo once weekly
15746836|NCT04885621|Dietary Supplement|nutrisystem-D|Nutrisystem meal replacements and Glytec glucomander-outpatient algorithm for insulin management decisions
15746837|NCT04885608|Other|PReGe|There will be two weekly sessions of 45 minutes, outdoors in outdoor fitness parks. The components of balance, gait, resistance, strength and elasticity will be worked on and breathing exercises will be performed. The sessions will be guided and dosed by physiotherapists, considering the level of perception of effort. Indications will be given to carry out other sessions of 60 to 120 minutes of therapeutic walking (minimum speed of 4 km/hour) during the week, to complete the 150-300 minutes per week of physical activity recommended by the WHO.
15746838|NCT04885595|Procedure|Forceps biopsy and cryobiopsy|Once the nodule is visualized by radial EBUS, the position of the probe in relation to the lesion is noted. Routinely, forceps biopsy and cryobiopsy are used serially in each patient within the same session.
15746839|NCT04885582|Other|HLA antigen results|HLA-A, HLA-B, HLA-DR tissue matching results in both groups will be compared.
15746864|NCT04885348|Behavioral|Control Group (Dental Home Education Leaflets)|Only Dental Home Education Leaflets were provided every six months for 2 years.
15747159|NCT04882800|Device|extended wear hearing aid B|commercially available extended wear technology
15746840|NCT04885569|Behavioral|CBT based Motivational interviewing (MICBT)|The culturally adapted MICBT will include approaches of motivational interviewing. Motivational interviewing (MI) is a well-developed and researched tool, for exploring and resolving the ambivalence to change substance use behaviour. While MI is seen as an acceptable and effective intervention to increase and consolidate motivation, to make positive changes in individuals with problematic substance use. The intervention recognises that ambivalence to change substance use behaviour is common and deals with it in the early stages of therapy using MI techniques. The intervention also recognises the need to identify and address obstacles in changing drug taking behaviour and offers ways of managing these difficulties from a cognitive behavioural formulation.
15746841|NCT04885569|Behavioral|Mindfulness based Relapse Prevention (MBRP)|MBRP has been designed as a manualized outpatient aftercare program that incorporates cognitive-behavioural skills (i.e., effective coping skills, self-efficacy, and recognizing common antecedents of relapse) with mindfulness-based practices to decrease the probability of relapse by increasing awareness and flexible responding in the presence of substance use triggers. Exercises and practices of intervention are designed to explore the functions of habitual reactive behaviour such as substance use focusing the balance and relationship between acceptance of present moment and skilful action that makes real changes.
15746842|NCT04885569|Behavioral|Integrated MICBT and MBRP (CAMIAB)|This will be integrated CBT based motivational interviewing plus mindfulness based relapse prevention intervention group.
15746843|NCT04885556|Device|Tampon-like device for absorption of sexual fluids|Subjects will insert a tampon-like device to absorb sexual fluids after intercourse
15746844|NCT04885530|Drug|Ivermectin|"Each participant will receive a total of twenty 7-mg tablets to be taken as directed based on their weight. The tablets are white, round, biconvex tablets with 123 over the scoring on one side. All packaging will be labeled to indicate that the product is for investigational use."
15746845|NCT04885530|Drug|Fluvoxamine|"Fluvoxamine is a round golden 50 mg tablet that is scored on both sides - one side has APO and the other side has F50 with a partial bisect. All packaging will be labeled to indicate that the product is for investigational use, administered at a dose of 50 mg, twice daily for 10 days."
15746846|NCT04885530|Drug|Fluticasone|Fluticasone furoate is an inhaled powder drug product composed of fluticasone furoate. It is a synthetic trifluorinated corticosteroid that is insoluble in water. Fluticasone furoate is a white powder and will be provided in a two tone grey inhaler with a mouthpiece cover and separate foil blister strips. The inhaler will be packaged in a moisture-protective foil tray with a desiccant and a peelable lid.All packaging will be labeled to indicate that the product is for investigational use. Participants will self-administer 200 µg (1 blister) of fluticasone furoate once daily for 14 days.
15746847|NCT04885530|Other|Placebo|Each study arm will contain a placebo comparator. Placebo will look similar to study drug and will be administered via the same route of administration and dose. However, placebo will be an inactive substance, containing no study drug.
15746848|NCT04885517|Device|Esophageal catheter|Patients are equipped with an esophageal catheter: positioning is performed after accurate nasopharyngeal anesthesia with lidocaine
15746849|NCT04885491|Drug|Placebo|Observational period with placebo infusion during 2 hours.
15746850|NCT04885491|Drug|PDNO|Infusion of PDNO. Starting with dose escalating and then treatment up to 8 hours.
15746851|NCT04885478|Other|Immune response monitoring , blood samples|"In both cohorts:
~-SARS-CoV-2 IgG and IgM antibodies, ( Nucleocapside, Spike) in 8 visits during a year.
~Infected HCW:
~Cytokines and T-Cell determination at baseline, 30, 60,180 days, 365 after positive test ( RT-PCR or SARS-CoV-2 antibodies )
~Covid-19 Symptoms, clinical monitoring"
15746852|NCT04885465|Behavioral|web-based psychoeducational support|Caregivers in the experimental group will have access to psycho-educational support through a web-based plattform during 3 months.
15746853|NCT04885452|Other|biobank|"Blood samples (biobank) at Day 0, Day 7, Month 1 and possibly Month 3 (only for the first 100 participants) (serum, plasma and whole blood)
~For participants in the immunological ancillary study: additional blood sampling at Day 0, Day 7 and Month 1 (PBMC)
~Nasopharyngeal swabs: Day 0, Day 7 (Day 14 and Day 21 if RT-PCR positive respectively at Day 7 and Day 14)
~Specific nasopharyngeal swabs in hospitalized patients: Day 3, Day 5"
15746854|NCT04885439|Behavioral|NextSteps|Intervention sessions are delivered by a Masters level trained interventionist. During sessions, the interventionist will: conduct the weekly symptom screen, review content, answer questions, ensure skills mastery through homework review, and work with participants to develop action plans and identify/overcome barriers to self-care/caregiving. Patients and caregivers will receive individual calls from the interventionist for sessions 1, 2, and 3, and participate together for sessions 4, 5, and 6 via speakerphone.
15746855|NCT04885426|Drug|low-dose metformin|Metformin Pill 250mg/day
15746856|NCT04885426|Drug|high-dose metformin|Metformin Pill 500mg/day
15746857|NCT04885426|Drug|Placebo|Placebo
15746858|NCT04885413|Drug|Niraparib in Combination With Anti-PD1 Antibody|Sintilimab： 200mg i.v., d1, 21days one cycle Niraparib： 200mg p.o qd，d1-d21, 21days one cycle
15746859|NCT04885400|Behavioral|iJobs|During the program, the participants will learn and exercise successful job search strategies. The web-based adaptation of the Jobs program will allow self-administration. After each session, they will receive written feedback from trainers on the platform.
15746860|NCT04885387|Device|chest CT|chest CT pectus deformities diagnostic
15746861|NCT04885387|Device|Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device|Magnetic Resonance Imaging and a low-cost portable three-dimensional scanning device pectus deformities diagnostic
15746862|NCT04885361|Biological|CoVepiT (OSE13E)|Study will be open label and will be randomized 1:1 in two parallel study arms receiving either one single dose or two doses separated by 21 days.
15746863|NCT04885348|Behavioral|Intervention Group (Dental Home Visits + Dental Home Education Leaflets)|No drugs were given in the Intervention. The intervention group received Dental Home Visits consisted of 6 monthly home visits by oral health therapists/dental home visitors where they deliver dental care advice to the parents for durations of approximately 30 minutes until follow-up at two years. Dental Home Education Leaflets (DHELs) and oral health messages were delivered through a personalized approach that avoids direct persuasion. These messages included information on daily tooth brushing with fluoride toothpaste, controlling dietary sugar intake, and the need for regular dental check-ups. The families were also be provided with information about local dental services available in their vicinity and how to access these services.
15746865|NCT04885335|Other|PAS (Pediatric Appendicitis Score) survey|Score ≤ 5: appendicitis unlikely. Score ≥ 6: probable appendicitis. core ≥ 7: very probable appendicitis
15746866|NCT04885322|Device|Transcranial Direct Current Stimulation|In tDCS, saline-soaked electrodes are temporary affixed to the scalp and connected to a battery-powered current generator. A weak (2 mA) constant current is then briefly applied (~20 minutes) to stimulate the targeted brain area. The targeted brain area is determined by the Study Arm.
15746867|NCT04885309|Procedure|Nerve Stimulator-guided Obturator Nerve Block|Following the confirmation of spinal anesthesia level in the patients in the ONB group while in the lithotomy position, ONB was applied unilaterally or bilaterally, depending on the tumor position. A needle with a nerve stimulator was advanced vertically 2 cm below and 2 cm from the pubic tubercle. The needle is inserted through the skin and into the lower ramus of the pubic bone. When contraction was observed in the adductor muscle groups and the aspiration was negative, 10 mL 0.25% levobupivacaine at 0.3-0.5 mA was administered. The operation was started 10 minutes after the injection. TURBT operations were performed with a 30 degree optic and a 26 F bipolar resectoscope. All spinal anesthesia and ONB procedures were performed by the same anesthesia team. All TURBT operations were performed by the same surgeon.
15746868|NCT04885270|Drug|cisplatin i.p.|paclitaxel 135 mg/m2 i.v. and cisplatin 75 mg/m2 i.p. on day 1
15746871|NCT04885244|Procedure|Index or spine revision surgery for complex adult spinal deformity|Surgical interventions will be patient specified by treating surgeon.
15746872|NCT04885231|Behavioral|Perioperative Pain Management Education and Counseling|All patients will receive both verbal postoperative pain management education and counseling as well as a written handout. Multi-modality non-opioid methods of pain control will be thoroughly discussed.
15746873|NCT04885218|Drug|SHR-1209 ;placebo|SHR-1209/placebo high dose
15746874|NCT04885218|Drug|SHR-1209 ;placebo|SHR-1209/placebo medium dose
15746875|NCT04885218|Drug|SHR-1209 ;placebo|SHR-1209/placebo low dose
15746876|NCT04885205|Behavioral|cognitive behavioral therapy for insomnia (CBT-I)|The CBT-I program is a 6-week, 1x/week, one-on-one program. The delivery of CBT-I will be done remotely over a secure teleconference service (Zoom) or phone. Participants will maintain a sleep diary during the course of the program to aid in tailoring the intervention. Each session lasts about 45-60min:
15746877|NCT04885192|Other|Stepped-Care Model|"Step 0: Screening via Manage My Pain (MMP) App. Patients using MMP will be prompted to complete questionnaires on pain catastrophizing, depressive symptoms, anxiety, suicide risk and opioid risk. Those scoring above clinical risk cut-offs will be referred to Step 1.
~Step 1: Acceptance and Commitment Therapy (ACT) Workshop. Patients will be offered a virtual ACT workshop focusing on practical coping skills for dealing with pain, emotional dysregulation, and disability, while maximizing functioning and quality of life with chronic pain. Thirty days later, patients will be prompted to complete all questionnaires through MMP again; those who score above clinical risk cut-offs will be referred to Step 2.
~Step 2: Dialectic Behavior Therapy (DBT) group. A 6-week DBT-based skills group will cover topics such as self-compassion, radical acceptance, distress tolerance, and mindfulness, among others. Thirty days later, patients will be prompted to complete questionnaires through MMP."
15746878|NCT04885179|Other|no intervention|No interventions are involved in this observational study.
15746879|NCT04885166|Other|Web-based placebo presentation|This presentation will discuss the prevalence of psychological disorders in college students, their etiologies, psychiatric medications, and students' personal experiences navigating college with a diagnosis of an anxiety and learning disorder, respectively. Attention-deficit/hyperactivity disorder and stimulant medications will be addressed, but diversion and medication misuse will not be discussed.
15746880|NCT04885166|Behavioral|Web-based simulation active intervention|This intervention engages students in interactive discussions with virtual humans to (a) learn about the actual prevalence of NMUPS and diversion and their related risks, (b) practice using refusal strategies when approached for their medication in high-risk situations, and (c) understand how to effectively communicate with prescribers and avoid medication misuse.
15746881|NCT04885153|Drug|Fenofibrate|Patients were given simvastatin 10 mg and fenofibrate 200 mg daily for three months and were evaluated monthly.
15746882|NCT04885153|Drug|Placebo|Patients were given simvastatin 10 mg and placebo (lactic acid) 200 mg daily for three months and were evaluated monthly.
15746883|NCT04885140|Behavioral|Feedback-based health education|This study was approved by the Tianjin Hospital Ethics Committee, (2019082).The CONSORT 2010 statement: extension to cluster-randomised trials checklist.(Campbell et al., 2012) was used to guide reporting outcomes (File S1).Specific measures have been listed above.
15746884|NCT04885140|Behavioral|Routine health education|Routine health education was given to the patients, and the content of health education was the same as that of the experimental group, including the introduction of the disease, clinical manifestations, significance of examination, therapeutic principles of operative methods, psychological nursing, and postoperative rehabilitation exercise, etc. To verify the effect of health education by feedback method.
15746885|NCT04885127|Other|Palliative Care + Digital Symptom Monitoring|Previously described in Arm description
15746886|NCT04885114|Genetic|Intraparenchymal rAAV1 - (mi)RNA HTT|Single dose MRI guided intraparenchymal infusion of rAAV1 - (mi)RNA HTT.
15746887|NCT04885101|Procedure|LISWT Group|The treatment consists of a weekly session and 4,000 pulses will be emitted each of the eight sessions totaling 32,000 pulses with a frequency of 18Hz and 100mJ of energy.
15746888|NCT04885101|Procedure|NARFT Group|The device used will be with an intensity of 350 Wpp; 75% pulsed operation mode; frequency of 640 kHz, 1200 kHz and 2400 kHz. Eight radio frequency sessions will be held with an interval of seven days between them.
15746889|NCT04885101|Procedure|Sham Group|In the RNA group, radiofrequency will be applied, the device used will be the Nèartek Esthetic Ibramed - Tecarterapia e Radiofrequency Apparatus, with an intensity of 350 Wpp; 75% pulsed operation mode; frequency of 640 kHz, 1200 kHz and 2400 kHz. The radiofrequency will be applied with the patient in the supine position on both sides of the penis with an opposite dispersion plate against the radiofrequency emitter. To perform the procedure, the therapist will use a glove. Eight radio frequency sessions will be held with an interval of seven days between them.
15746890|NCT04885088|Device|Wisdom bracelet|Wisdom bracelet
15746891|NCT04885075|Drug|IV diazepam|inj.diazepam 0.2mg/kg/dose stat
15746893|NCT04885062|Device|Belun Ring|The Belun Ring sensor will be applied to the proximal phalanx of the index finger in the non-dominant hand of the participating individuals prior to their sleep onset in the sleep lab and will be removed upon awakening at the end of the sleep period on the following morning. The attended in-lab sleep study will be performed simultaneously in a standard fashion.
15746894|NCT04885062|Diagnostic Test|PSG|All patients scheduled for attended overnight in-lab polysomnography (PSG) in our 2 sleep labs will undergo PSG testing. On the same night of the PSG testing, these same patients will also wear the Belun Ring device. After the study, we will compare results of the Belun Ring device vis-à-vis with the results of the PSG on the same patient.
15746895|NCT04885049|Drug|Racecadotril|Anti secretary
15746896|NCT04885049|Drug|DiaResQ Children's Powder for Suspension|oral immunoglobulins
15746897|NCT04885036|Behavioral|EFST brief intervention|"EFST is a transdiagnostic group parent guidance program, delivered in two consecutive days, totally 13 hours, 6-16 parents in each group, ideally both parents of a referred child.
~The overall goal of EFST is to increase parents' emotional competence, to help parents work through their emotional barriers, such as fear and shame, that hinders them from parenting in an efficient way. EFST supports the parents to follow their intention to actively engage in their child's recovery process by increase parental self-efficacy, parental emotional competence, their ability to repair and strengthen the relationship with the child.
~The treatment involves only the parents and the assumption is that through this intervention, the parents provide a better emotional guidance to their child."
15746898|NCT04885036|Behavioral|EFST extended intervention|EFST extended intervention is a stand-alone treatment that consist of the two days EFST group course followed by six weekly individual sessions of parental guidance by a licensed EFST therapist. The treatment is given indirectly to the child through work with the parent, thus it might remove or diminish the pressure on the children that suffer from mental health problems to solve their disorder themselves. In this condition a total of 19 hours of EFST treatment is provided.
15746899|NCT04885036|Behavioral|Treatment As Usual|In the TAU condition, the families will receive treatment as usual that does not include EFST treatment. Recent research indicates that this is therapy of high quality carried out by highly qualified staff (Tilden et al., 2020; Zahl-Olsen et al., 2020).The therapists are educated psychologists, psychiatrist and family therapists. The TAU intends to be the best treatment for the child/ family based on the type of symptoms presented and requests from the patient and his/her family. We will measure the intensity and type of therapy given in this condition by information from the therapists and investigate that it did not include the main elements of EFST treatment.
15746900|NCT04885023|Other|Hippotherapy|The hippotherapy program for 10 weeks
15746901|NCT04885010|Dietary Supplement|probiotics|participants will be given probiotics twice a day for 15 days
15746902|NCT04885010|Dietary Supplement|placebo|participants will be given a placebo twice a day for 15 days
15746903|NCT04884997|Drug|toripalimab|toripalimab 3mg/kg, Q2w;
15746904|NCT04884997|Drug|Temozolomide Injection|Temozolomide 150mg/m2,d1-5,Q4w
15746905|NCT04884984|Biological|anti-CLL1 CART|Split intravenous infusion of anti-CLL1 CAR T cells [dose escalating infusion of (5-20)x10^6 anti-CLL1 CAR T cells/kg].
15746906|NCT04884971|Drug|Intestinal microbiota transplant (IMT)|Two size 00 capsules from a single lot will be taken daily. Approximately 2.0 x 10^11 bacteria from a healthy donor are contained in each capsule.
15746907|NCT04884945|Procedure|Open Pyeloplasty (OP)|Open approach for the surgical correction of UPJ obstruction
15746908|NCT04884945|Procedure|Robotic-Assisted Laparoscopic Pyeloplasty (RALP|Robotic approach for the surgical correction of UPJ obstruction
15746909|NCT04884932|Device|30 kHz stimulation (Myomed 932, Enraf-Nonius)|"A charge-balanced, symmetric, biphasic sinusoidal current without modulation will be delivered at a frequency of 30 kHz. The stimulation intensity will be defined as that sufficient to produce a strong but comfortable sensation, just below motor threshold, over the median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft,Netherlands)"
15746910|NCT04884932|Device|Sham stimulation (Myomed 932, Enraf-Nonius)|Sham stimulation will be delivered at a frequency of 30 kHz only during the first 30 seconds.
15746911|NCT04884919|Device|Regular Gauze|Regular gauze
15746912|NCT04884919|Device|Chitosan Dressing|Dressing made of chitosan material
15746913|NCT04884906|Biological|Camrelizumab|200mg/m2, iv, d1, Q3W, a total of 6 cycles
15746914|NCT04884906|Radiation|radiotherapy|1.8-2.15Gy/time (radiotherapy started on the 8th day of camrelizumab treatment), a total of 28 times (5 times a week), a total of 50.4-60.2Gy.
15746915|NCT04884906|Drug|Albumin Paclitaxel|260mg/m2, iv, d1, Q3W, a total of 6 cycles
15746916|NCT04884906|Drug|Cisplatin|80-120mg/m2, iv, d1-3, Q3W, a total of 6 cycles
15746917|NCT04884893|Drug|Nitrous Oxide|50% nitrous oxide
15746918|NCT04884880|Drug|Luo-Fu-Shan Plaster|Luo-Fu-Shan Plaster 10g，once daily，4 weeks
15746919|NCT04884880|Drug|The placebo 10g|Placebo 10g，once daily，4 weeks
15746920|NCT04884867|Behavioral|CBT-based supportive skills delivered by phone by lay coaches|8-10 weekly coaching sessions delivered by telephone
15746921|NCT04884854|Device|Efferon LPS|Efferon LPS is a single-use therapeutic device for extracorporeal blood purification using direct hemoperfusion. Detoxification is carried out by selective adsorption of lipopolysaccharides (bacterial endotoxins) and non-selective removal of cytokines by internal porous structure. It is a cylindrical polycarbonate casing filled with spherical granules of LPS-selective polymeric adsorbent mesoporous beads and isotonic sodium chloride solution. The device is registered in Russia as a medical device RZN 2019/8886.
15746922|NCT04884841|Other|Patients diagnosed with postoperative complications|Patients diagnosed with postoperative complications (Acute kidney injury, Chronic Kidney disease, Infection, Delirium, MACCE, Myocardial infarction, Postoperative pulmonary complications, major bleeding, ECMO, IABP....)
15746923|NCT04884841|Other|Patients without postoperative complications|Patients without postoperative complications
15746988|NCT04884321|Other|Complementary And Alternative Medicine|No intervention was done in the cross-sectional study
15746989|NCT04884308|Biological|BCG TICE Vaccine|Intradermal vaccination with BCG TICE
15746990|NCT04884295|Drug|XVR011|Single dose of XVR011 via intravenous (IV) infusion
15746991|NCT04884295|Drug|Normal saline|Single dose of normal saline via IV infusion
15747160|NCT04882787|Device|BTE hearing aid|Amplification
15746924|NCT04884828|Device|external gas during NIV|The procedure was performed in the patient's room during his or her hospital stay to avoid additional visits for study participation. The patient was placed in the supine position, and the usual ventilator interface was placed in a single-limb system, along with the commercial ventilator to be studied. The ventilator model were evaluated at bedside in random order. The parameters of the ventilator were the same as those that the patients used at home (that is, unlike the bench study, the sensitivity of the trigger was not modified). A external polygraph was used to moritor the study, with the incorporation of thoracic and abdominal bands and parasternal electromyography, to better evaluate asynchronies, in addition to pulse oximetry control. The ventilation periods were 1 minute (without gas, gas, without gas). This sequence was performed twice in each group of established conditions.
15746929|NCT04884802|Procedure|Tight pressure management|Norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg, delayed resumption of chronic antihypertensive medications, and a target ward MAP ≥80 mmHg (tight pressure management)
15746930|NCT04884802|Procedure|Routine pressure management|ACEIs, ARBs, and/or calcium channel blockers can be given the morning of surgery if deemed appropriate by the attending anesthesiologist. Intraoperative blood pressure will be managed per clinical routine. As usual, chronic anti-hypertensive medications will be restarted shortly after surgery unless contraindicated by hypotension.
15746931|NCT04884802|Drug|Induction agent|etomidate and propofol - randomly assigned
15746932|NCT04884802|Drug|Vasopressor|pressure maintenance with phenylephrine and norepinephrine - randomly assigned
15746933|NCT04884789|Device|COFIS 3D|Patient have to wear the COFIS 3D 20h a day for at least 6 month
15746934|NCT04884776|Dietary Supplement|Microbiome immunity formula|Microbiome immunity formula contains probiotics blend (3 Bifidobacteria, 10 billion CFU per sachet)
15746935|NCT04884776|Dietary Supplement|Active placebo|Active placebo contains active vitamin
15746936|NCT04884763|Drug|Erenumab-aooe (EREN) 140 mg s.c. administered every four weeks for a total of five treatments|Erenumab-aooe (EREN) 140 mg s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments
15746937|NCT04884763|Drug|Placebo (EREN-P) s.c. administered every four weeks for a total of five treatments|Placebo (EREN-P) s.c. administered at baseline and weeks 4, 8, 12 and 16 for a total of five treatments
15746938|NCT04884750|Behavioral|ECA-ACE Vaccination Promotion Intervention|A smartphone-based embodied conversational agent that educates users and motivates them to obtain vaccinations for SARS-CoV-2 and Influenza, according to Boston Public Health Commission guidelines.
15746939|NCT04884737|Other|Mepilex Border Flex® (MBF) dressing|A new dressing technology (Mepilex Border Flex® (MBF)) provides increased conformability of the dressing to the skin with the ability of the dressing to move in all directions (e.g., 360-degree flexibility) with even slight body movements. Limited data exists on use of silicone foam dressings with all direction flexibility during prone surgical procedures.
15746940|NCT04884724|Other|Adaptive Dance Exercise Program|It is planned to include balance, stabilization, mobility, speed and rhythm activities for the exercises applied in Cerebral Palsy rehabilitation and based on the principles of motor learning, and to apply the dance steps and figures to be applied with visual and auditory stimuli.
15746941|NCT04884711|Other|No Interventions. Participants will be using their everyday digital health technologies.|The investigators will be involving older people to understand the barriers & facilitators of digital health technology adoption for homebound older people. In this process no interventions will be given by us.
15746942|NCT04884711|Other|In depth Interviews|In-depth interviews will be conducted to gather lived experiences of homebound older people.
15746943|NCT04884711|Other|Focus Group Discussions|Focus Group Discussions will be used to create avenues to enhance dignity and human perspectives in digital designs for older people.
15746944|NCT04884698|Device|Stimit Activator|"The Stimit Activator Device is composed of three components.
~A magnetic stimulator generating current pulses
~A novel Stimit coil design optimized for phrenic nerve stimulation
~A coil positioning device for quick, easy and reproducible coil positioning"
15746945|NCT04884685|Biological|SARS-CoV-2 Inactivated Vaccine|600SU inactivated virus in 0·5 mL of aluminium hydroxide solution per injection
15746946|NCT04884685|Biological|Placebo|aluminium hydroxide solution only
15746947|NCT04884672|Device|SMILE|Small incision lenticule extraction, a refractive surgery procedure for the corrcetion of myopia with or without astigmatism
15746948|NCT04884659|Other|Time restricted feeding arm|80% of calories consumed before 2PM, remaining 20% consumed by 4PM. Fasting for 14-16 hours
15746949|NCT04884659|Other|usual feeding pattern arm|All meals consumed ad lib with 50% of calories consumed after 4PM
15746950|NCT04884646|Other|VR with Routine physical therapy and Virtual reality|VR group will be treated with virtual reality for 15 to 20 minutes along with routine physical therapy for 40 minutes session 3 days/week for 12 weeks
15746951|NCT04884646|Other|Motor Imagery with Routine physical therapy|MI group will be treated with virtual reality for 15 to 20 minutes along with routine physical therapy for 40 minutes session 3 days/week for 12 weeks
15746952|NCT04884646|Other|Routine physical therapy|Group A will be given routine physical therapy in 40-min sessions and 20 min of walking and cycling with a short period of rest, every alternate day (3 days per week) for 12 weeks
15746953|NCT04884633|Procedure|Pancreatic islet transplantation|New method of pancreatic islet transplantation into the omentum using a biodegradable scaffold
15746992|NCT04884282|Drug|Tedopi|TEDOPI is a T-specific immunotherapy was designed to induce cytotoxic T-lymphocytes against five five tumor associated antigens (ie CEA, p53, HER-2/neu, MAGE2 and MAGE3)
15746993|NCT04884282|Drug|Nivolumab|Nivolumab is a soluble protein consisting of 4 polypeptide chains, which include 2 identical heavy chains and 2 identical light chains. Nivolumab is produced from cell culture using a CHO cell line.
15747022|NCT04884035|Drug|Cyclophosphamide|Cyclophosphamide 750mg/m2 on Day 1 by IV infusion of a 21-day treatment cycle for up to a total of 6 cycles
15746954|NCT04884607|Other|subthreshold low-level autonomic nerve stimulation using external auditory canal electrodes|"Evaluation of electrocardiogram measurement from external auditory canal electrodes: Participants are required to attach specially designed external auditory canal electrodes to their both ears to record electrocardiogram. Both electrocardiogram from the precordium and the ear would be simultaneously recorded and compared.
~Evaluation of low-level autonomic nerve stimulation using external auditory canal: Using the electrodes described above, Arnold's nerve will be stimulated with low-level electric impulses using TENS device. During and after the stimulation, heart rate variability will be measured to investigate the impact of nerve stimulation on autonomic function modulation on the heart."
15746955|NCT04884594|Drug|AAV8-hCocH|2e12 vg/kg single infusion intravenous
15746956|NCT04884594|Drug|AAV8-hCocH|6e12vg/kg single infusion intravenous
15746957|NCT04884594|Drug|AAV8-hCocH|2e13 vg/kg single infusion intravenous
15746958|NCT04884581|Device|GI Genius CADx device|GI Genius System is an Intelligent Endoscopy Module designed to be an adjunct to video colonoscopy with the purpose of supporting the operating physician with artificial intelligence during colonoscopy. GI Genius CADx is the AI software that provides a histology prediction of framed polyps during real-time colonoscopy, with each polyp being classified as adenoma or non-adenoma.
15746959|NCT04884568|Device|Exufiber|Wound dressed with Exufiber for up to 21 days.
15746960|NCT04884555|Other|Standard neurorehabilitation|Routine post-stroke rehabilitation
15746961|NCT04884555|Diagnostic Test|Thiol-Disulphide Homeostasis|Monitoring the levels of thiol and disulphide in serum
15746962|NCT04884555|Diagnostic Test|Oxidized-reduced Glutathione Homeostasis|Monitoring the levels of intracellular oxidized glutathione and reduced glutathione in whole blood samples
15746963|NCT04884542|Device|Revision Total Knee Arthroplasty|Total Knee Arthroplasty in case of failure of a previous operation.
15746964|NCT04884529|Behavioral|Chair-yoga program|8-week chair yoga program with gentle postures, breathing techniques, and mindfulness.
15746965|NCT04884516|Dietary Supplement|Retinol gummy|Participants take one retinol gummy per day
15746966|NCT04884503|Drug|Clonazepam tablets|Dosing of clonazepam was as follows: in the first week, 1 mg to be sucked for 2 minutes, then swallowed (once a day in the morning), in the second week, 1 mg to be sucked for 2 minutes, and then swallowed (twice a day in the morning and one hour before falling asleep), in the third week, 1 mg to be sucked for 2 minutes and in the fourth week 1 mg to be sucked for 2 minutes, then swallowed (once a day in the morning)
15746967|NCT04884503|Device|tongue pads|wearing a tongue pad 3 times a day for 20 minutes for 4 weeks
15746968|NCT04884490|Drug|Co-trimoxazole|Tab. Co-trimoxazole 960 mg (trimethoprim 160mg + sulphamethoxazole 800mg) thrice (8 hourly) daily for 7 days orally.
15746969|NCT04884490|Drug|Placebo|Placebo thrice (8 hourly) daily for 7 days orally.
15746970|NCT04884477|Biological|Convalescent Plasma|Convalescent Plasma
15746971|NCT04884464|Device|Hyaluronic acid-based gel|Dosage: application of an even coat of 1mm thickness Frequency: 3 times/day (after main meals) Duration: 2 weeks
15746972|NCT04884464|Drug|Chlorhexidine Gluconate|Dosage: application of an even coat of 1mm thickness Frequency: 3 times/day (after main meals) Duration: 2 weeks
15746973|NCT04884451|Behavioral|Lifestyle modification|Diet and physical activity modification and behavioral approach
15746975|NCT04884425|Device|Pulsed Electromagnetic Frequency Device (Energy5)|A pulsed electromagnetic frequency (PEMF) device which is recommended to be used for 30 minutes a day
15746976|NCT04884412|Procedure|Surgery under general anesthesia with experimental targeting|Surgery will be performed under general anesthesia. The electrodes will be inserted directly on the targets without MER, with PARKEO_2 targets provided by the Bordeaux University Hospital, based on the machine-learning model developed in Bordeaux.
15746977|NCT04884412|Procedure|Usual Surgery|In the control group, surgery will be performed as usual in each centre under local or general anaesthesia. This group represents the current state of the art of deep brain stimulation in these centres.
15746978|NCT04884399|Drug|CMAB818|vascular endothelial growth factor (VEGF) inhibitor
15746979|NCT04884399|Drug|Lucentis®|vascular endothelial growth factor (VEGF) inhibitor
15746980|NCT04884386|Device|robot-assisted gait training|RAGT, WALKBOT-G, is a walking training equipment that can reproduce natural motions by adjusting the leg length and adjusting the motion with the actuator of the ankle joint.
15746981|NCT04884386|Behavioral|conventional locomotion therapy|locomotion exercise, postural control training, balance training, electrotherapy
15746982|NCT04884373|Diagnostic Test|Gastric ultrasound|An ultrasound exam will be performed before induction of anaesthesia. GUS results from selected patients will be systematically acquired and assessed following an algorithm (Appendix Ia). The ultrasound results will be collected on a standardized form (Appendix IIa). The technique is performed in the supine and right lateral decubitus position (Appendix Ib) and only by anesthesiologists with sufficient experience with ultrasound and the technique. The patient will be asked to indicate his/her satiety on a predetermined ten-point scale.
15746985|NCT04884347|Dietary Supplement|Alline proMEN|1 tablet per day intake during the meal with a glass of water. Treatment duration: 3 months
15746986|NCT04884347|Dietary Supplement|Placebo|1 tablet per day intake during the meal with a glass of water. Treatment duration: 3 months
15746987|NCT04884334|Device|VAC-Stent®|treatment with the VAC-Stent®
15746994|NCT04884282|Drug|Docetaxel|Docetaxel is a cytotoxic microtubule inhibiting antineoplastic agent in the taxane class. Docetaxel monotherapy is indicated for locally advanced or metastatic NSCLC after failure of prior platinum- based chemotherapy.
15746995|NCT04884256|Drug|CBT-004|Dose response study
15746996|NCT04884243|Drug|CBT-006|Cyclodextrin
15746997|NCT04884230|Procedure|Oversewing|Oversewing of the gastric remnant
15746998|NCT04884217|Drug|Pro-ocular™ Topical Gel|Pro-ocular™ Topical Gel 1% is applied dermally to the forehead twice-daily
15746999|NCT04884217|Drug|Placebo Topical Gel|Placebo is a toopical gel without active ingredient applied dermally to the forehead twice-daily
15747000|NCT04884204|Behavioral|Lee Symptom Scala|Symptom identification and management with Lee Symptom Scale in follow up care
15747001|NCT04884191|Drug|Pacritinib|Pacritinib
15747002|NCT04884178|Device|Trifocal Preloaded IOL Delivery System|UV and blue-light filtering foldable trifocal IOL with a +2.2 diopter (D) addition power of intermediate visual acuity and a +3.3 D addition power of near visual acuity. This device is approved in Taiwan.
15747003|NCT04884165|Device|Remote monitoring of home mechanical ventilation (NIV) using SRETT|Patients will use the SRETT device attached to their home ventilator.
15747004|NCT04884165|Other|Home mechanical ventilation (NIV) without remote monitoring|Usual care
15747005|NCT04884152|Procedure|Home Exercise Group|Educational training program about bruxism and the other oral parafunctional activities in patients with myofascial temporomandibular disorders.
15747006|NCT04884152|Procedure|Telerehabilitation Group|Telerehabilitation program combined with educational training program about bruxism and the other oral parafunctional activities in patients with myofascial temporomandibular disorders.
15747007|NCT04884139|Drug|Dolutegravir/Lamivudine as a single pill|- Dose: Dolutegravir 50mg/ Lamivudine 300 mg -Route of adminstration: oral -Schedule of administration: once a day for 96 weeks.
15747008|NCT04884139|Drug|Bictegravir/Emtricitabine/Tenofovir alfenamide as a single pill.|"Dose: Bictegravir 50 mg/Emtricitabine 200 mg /Tenofovir alafenamide 25 mg
~Route of adminstration: oral
~Schedule of administration: once a day for 96 weeks."
15747009|NCT04884126|Procedure|dental implant placement|The time of dental implant surgery
15747010|NCT04884113|Device|Motorized Spiral enteroscopy|Small-bowel enteroscopy for diagnosis and intervention
15747011|NCT04884100|Other|Validating and improving PPG-based algorithms|Our project aims at validating and improving PPG-based algorithms that were previously developed during the time course of a preceding study mini-Holter, accepted by the CER-VD in 2015. The developed features might help improve our understanding of the physio-pathological expression of cardiac arrhythmias. Indeed, current evidence demonstrates that PPG signals contain rich information on diverse cardiovascular mechanisms and properties
15747012|NCT04884087|Behavioral|Ecological Momentary Assessment (EMA; Metricwire) Prompts 3x/day|Participants receive 3 EMA survey prompts daily for the duration of the study.
15747013|NCT04884087|Behavioral|Ecological Momentary Assessment (EMA; Metricwire) Prompts 6x/day|Participants receive 6 EMA survey prompts daily for the duration of the study.
15747014|NCT04884087|Behavioral|Incentive Structure - fixed|"Those assigned to the fixed incentive condition will earn a fixed bonus based on EMA completion (50-74%=$3; 75-89%=$5; ≥90%=$10) each week."
15747015|NCT04884087|Behavioral|Incentive Structure - prize based|"Those assigned to the prize-based incentive will be rewarded for high survey completion with increasing numbers of draws depending on their level of response to EMA prompts each week (50-74%=1 draw, 75-89%=2 draws, ≥90%=3 draws). For each draw, individuals will use the EMA app to spin the wheel to see which prize amount they earn. Out of a total of 500 total draws, 50% will be $1, 43.6% will be $3, 6% will be medium prizes ($5), and 0.4% will be a jumbo prize ($90)."
15747016|NCT04884074|Procedure|Standard Sleeve Gastrectomy plus Anterior Crural Repair|The procedure is performed in a similar fashion as standard sleeve gastrectomy. After gastric mobilization is completed as standard sleeve gastrectomy, the anterior phrenoesophageal ligament is divided and distal 3cm esophagus is mobilized. A Mid-Sleeve tube (40Fr) is inserted per-orally by the anesthetist and the hiatus opening is closed with 2/0 non-absorbable suture over the bougie anterior to the esophagus. The hiatus repair was sized by comfortably placement a dissection forceps adjacent to the esophagus without tension. Sleeve gastrectomy is then performed as the standard technique.
15747017|NCT04884074|Procedure|Standard sleeve gastrectomy (SSG, the control group)|"The procedure is performed in French position with a standard 5-port approach and a pneumoperitoneum not exceeding 15mmHg.
~The greater omentum is then completely detached from the greater curvature of stomach using either ultrasonic or bipolar shear device. All adhesion between posterior gastric wall and pancreatic capsule is freed and the cardia is completely free with left crura completely exposed. A Mid-Sleeve tube (40Fr) is inserted per-orally by the anesthetist with its balloon tip reaching the gastric antrum and insufflated with 50cc of air. Sleeve gastrectomy is then performed using laparoscopic linear staplers, starting from a point 5-6cm proximal to the pylorus up cardia at about 1cm lateral to the angle of His, along the Mid-sleeve tube which is lying against the lesser curve of stomach. The staple line is reinforced with absorbable sutures. Distal stomach is anchored at retroperitoneum with non-absorbable stitch."
15747018|NCT04884061|Other|NBI images and/or videos|A library of NBI images and/or videos will be established from previously recorded bronchoscopies in 30 patients (10 with a SARS-CoV2 infection, 10 with a lower respiratory tract infection not related to SARS-CoV2, and 10 in patients with pulmonary nodule). NBI images and/or videos of the bronchial tree will then be analysed by three experimented interventional pulmonologists blinded to the patient ID. Each investigator will describe the vasculature pattern according to a prespecified grid: Normal mucosal vascularity / increased capillary density / presence of capillary loops / presence of dotted vessels / complex vascular networks of tortuous vessels or abrupt ending vessels / dilated longitudinal vessels. In case of discordance between the investigators, images will be reviewed to obtain a consensus.
15747019|NCT04884048|Diagnostic Test|Radiographs|Analysis of the images acquired for the initial characterization of bone lesions using a systematic report system
15747020|NCT04884035|Drug|CC-220|CC-220 by mouth at the assigned dose starting on Day 1 for 14 consecutive days of the 21-day treatment cycle for 6 cycles of treatment.
15747021|NCT04884035|Drug|Rituximab|Rituxan 375 mg/m2 on Day 1 by intravenous (IV) infusion or 1400 mg (SC) subcutaneous (from Cycle 2) of a 21-day treatment cycle for up to a total of 6 cycles
15747237|NCT04882228|Drug|Venitol Tab.|twice daily for 8 weeks
15747023|NCT04884035|Drug|Doxorubicin|Doxorubicin 50 mg/m2 IV infusion on Day 1 of a 21-day treatment cycle for up to a total of 6 cycles
15747024|NCT04884035|Drug|Vincristine|Vincristine 1.4 mg/m2 (maximum of 2.0 mg total) IV intravenous on Day 1 of a 21-day treatment cycle for up to a total of 6 cycles
15747025|NCT04884035|Drug|Prednisone|Prednisone 100 mg PO on Days 1 through 5 of each 21-day treatment or 100mg IV on Day 1 is also acceptable for up to a total of 6 cycles
15747026|NCT04884035|Drug|CC-99282|CC-99282 by mouth at the assigned dose starting on Day 1 for 7 consecutive days of the 21-day treatment cycle for 6 cycles of treatment.
15747027|NCT04884022|Procedure|Miniplates in mandibular symphysis & infrazygomatic|Fixed functional appliance (pushing orthopedic force) in conjunction with direct skeletal anchorage
15747028|NCT04884022|Procedure|Miniplates in external oblique ridge & anterior maxillary region|Coil spring (pulling orthopedic force) in conjunction with direct skeletal anchorage
15747029|NCT04884009|Drug|SHR-1701； Famitinib|SHR-1701+ Famitinib
15747030|NCT04884009|Drug|SHR-1701|SHR-1701
15747031|NCT04883996|Drug|1% EXP039|1% EXP039 (commercially available as Isopto® Carpine) contains 1% active ingredient (10 mg/mL),
15747032|NCT04883996|Other|Saline control|Saline
15747033|NCT04883983|Drug|Open Label Placebo|Pain medication will be prescribed per standard treatment for initial prescription. Pain medication request at followup will be filled with open label placebo. Pain assessment surveys will be used at 2, 6, and 12 week followups.
15747034|NCT04883983|Drug|Patient medication as standardly prescribed|Pain medication will be prescribed per standard treatment for initial prescription. On request for additional pain medication, pain medication will be prescribed as per the standard protocol. Pain assessment surveys will be used at 2, 6, and 12 week followups.
15747035|NCT04883970|Other|124I-18B10(10L) PET/CT|Study participants will undergo 124I-18B10(10L) PET/CT scans
15747036|NCT04883957|Drug|BGB-11417|Film-coated tablets administered orally as specified in the treatment arm.
15747037|NCT04883944|Other|Intervention group|"Mother will be involved in implementing the non-pharmacological techniques during the performance of the heel stick procedure as follow:
~swaddling;
~non-nutritive sucking with pacifier in infants with PMA < 32 weeks;
~nutritional sucking with sucrose and/or breast milk in infants with PMA ≥ 32 weeks;
~holding;
~exposure to maternal voice."
15747038|NCT04883944|Other|Standard care group|"A second nurse will perform the non-pharmacological techniques during the performance of the heel stick procedure without the maternal involvement as follow:
~swaddling;
~non-nutritive sucking with pacifier in infants with PMA < 32 weeks;
~nutritional sucking with sucrose and/or breast milk in infants with PMA ≥ 32 weeks;
~holding."
15747039|NCT04883931|Drug|Normal Saline|0.5 ml 0.9% normal saline will drop on both eyes twice in a day.
15747040|NCT04883931|Biological|Breast milk|0.5 ml breast milk from all infant's own mother will drop both eyes twice in a day
15747041|NCT04883918|Biological|ASC930|4 intravenous doses of ASC930
15747042|NCT04883892|Procedure|BMAC|"patients will be injected with BMAC into the ankle joint, after treatment patients will be followed up to 24 months. In particular patients will be assessed after treatment at 1, 3, 6, 12 and 24 months.
~During the injection, samples of BMAC will be collected for the characterization of the phenotype markers and clonogenic capability"
15747043|NCT04883892|Procedure|HA|patients will be treated with two injection of HA, one every 15 days, into the ankle joint. After treatment these patients will be followed up to 24 months. At 12 months patients can decide to cross.over in the BMAC arm treatment. After cross-over patients will be assessed for further 12 months.
15747044|NCT04883866|Behavioral|Telephone Breastfeeding Support Program|On the 3rd day after discharge, a reminder messages will be sent to the mothers in the inter vention group. Throughout the program, 21 reminder messages will be sent to mothers in the first month after discharge to support the mother and encourage breast milk via a messaging application (whatsapp, bip, telegram, etc.). In addition, a total of seven phone calls, once a week in the first month after discharge and once a month in the eighth, twelfth and sixteenth weeks, will be made to check personalized information about individual breastfeeding questions of mothers.
15747045|NCT04883866|Behavioral|Sending a breastfeeding guide for premature babies to the phone of mothers in addition to the routine discharge procedure|In addition to the routine discharge procedure, a breastfeeding guide for premature babies will be sent to the mothers' phone.
15747046|NCT04883853|Procedure|Mild _moderate Ptosis tucking|A modified levator muscle tucking procedure.The level of sutures was determined according to the levator muscle function and the desired eyelid height. The middle (main) suture was taken first at the level of the medial part of the pupil and was tightened to keep the lid height at the superior limbus and the other two sutures (medial and lateral) were then adjusted. A spindle-shaped, horizontal part of the levator aponeurosis (2.5-3 mm wide and 0.5 mm deep) was excised at the site of insertion into the tarsus before tightening the central suture to induce strong fibrosis and adhesion between the tucked levator aponeurosis and the tarsus
15747047|NCT04883840|Drug|Rosuvastatin 10mg|Daily dose of one medication over 8 week period then switch to another medication over an 8 week period (type of medication during each intervention period is blinded and then randomized).
15747048|NCT04883827|Other|Blood collection|20-40 mL of blood to extract cell free DNA
15747049|NCT04883827|Other|Urine collection|up to 15 mL of urine to extract cell free DNA
15747050|NCT04883814|Diagnostic Test|18F-fluoroestradiol PET/CT|Estrogen receptor targeted imaging
15747051|NCT04883801|Diagnostic Test|Reviewed clinical records and laboratory results|Retrospectively reviewed clinical records and laboratory results
15747052|NCT04883788|Other|Pandemic period|Perioperative care (nursing and physiotherapy) provided to patients treated with hip and knee replacement during the pandemic period
15747053|NCT04883775|Drug|MVT-2163|MVT-2163 is administered intravenously as a PET imaging agent.
15747054|NCT04883775|Drug|MVT-5873|MVT-5873 will be administered intravenously over at least 60 minutes.
15747055|NCT04883762|Biological|Fecal Microbiota Transplantation (FMT)|Undergo FMT via colonoscopy.
15747056|NCT04883749|Biological|Acalabrutinib|Cycle (q28d): Acalabrutinib p.o.100 mg twice daily (BID)
15747057|NCT04883736|Drug|Tretinoin Gel Microsphere, 0.1%|The study medication will be self-applied topically, on the affected areas of the face lightly, once daily in the evening, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
15747058|NCT04883736|Drug|RETIN-A MICRO® (Tretinoin) Gel Microsphere, 0.1%|The study medication will be self-applied topically, on the affected areas of the face lightly, once daily in the evening, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
15747059|NCT04883736|Drug|Placebo Control|The study medication will be self-applied topically, on the affected areas of the face lightly, once daily in the evening, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
15747060|NCT04883723|Device|Shotblocker|Shotblocker is a small, flat, horseshoe-shaped plastic tool that can be used to reduce pain due to intramuscular injection, suitable for all age groups, without drug properties. It is used by keeping it on the skin surface during injection and has no side effects. Shotblocker has short, non-pointed blunt protrusions on one side that connect with the skin, there is a hole in the middle of the vehicle to expose the injection site. The protruding surface of the vehicle is placed in the area to be applied just before injection. The protrusions on the surface of the Shotblocker do not pierce the skin and provide a warning for the Door Control Theory, which is thought to exist regarding pain
15747061|NCT04883723|Other|Manual Pressure|The patient was placed in a prone position and the appropriate left or right ventrogluteal region was determined. Pressure was applied to the determined injection area with the thumb of the active hand for 10 seconds. Immediately after the application of pressure was terminated, the injection site was cleaned with an alcohol cotton pad with circular movements of 5 cm diameter from inside to outside, and the alcohol was allowed to dry. With a single movement at a 90 ° angle, the compression area was entered quickly and the injection was performed. Manual pressure reduces pain within the framework of the gate control theory. According to the gate control theory, when pressure is applied to an area, a fiber transmits the feeling of pressure instead of pain and ultimately the pain sensation is alleviated. There are many studies in the literature that prove the effectiveness of this method.
15747062|NCT04883710|Other|Gene therapy|This is a prospective patient registry.
15747063|NCT04883697|Other|vitrectomy with ILM peeling and ILM flap technique|outcomes after vitrectomy with ILM peeling and ILM flap technique for macukar hole repair are assessed
15747064|NCT04883684|Other|Personal health wallet service for Chronic Patients in Emergency Department|Patients(caregivers) will be provided the personal health wallet service and evaluate the effectiveness and satisfaction for the service.
15747065|NCT04883671|Other|Standard of Care|Participants will be randomly assigned and receive standard of care as determined by their physician and may include: palliative radiation and/or a systemic therapy (like chemotherapy, immunotherapy, or targeted therapies).
15747066|NCT04883671|Radiation|SBRT|SBRT to 1-3 sites of metastatic disease over the course of 1-8 business days to each area of cancer
15747067|NCT04883658|Drug|CKD-348(2)|QD, PO
15747068|NCT04883658|Drug|CKD-828, D097, D337|QD, PO
15747069|NCT04883645|Drug|Imiquimod 5% Cream,Top,Pkt,0.25Gm|Imiquimod as a 5% cream is being used to treat several skin cancers, including malignant melanoma, basal cell carcinoma (BCC) and SCC26-28. With respect to SCC treatment, it has been demonstrated that imiquimod stimulates tumor destruction by recruiting T cells (cells in the immune system) from blood and by inhibiting tonic anti-inflammatory signals within the tumor. The patient will be instructed to apply imiquimod cream, 7 nights a week for 4 weeks to the oral tumor at bedtime.
15747070|NCT04883632|Combination Product|Saypha Volume Lidocaine|correction of Nasolabial Folds using injection of Saypha Volume Lidocaine manufactured in 2 different plants at Croma Pharma
15747074|NCT04883593|Drug|TA103|The assigned Investigational Product will be applied to the skin between, under, all over the toes, sole and sides of the entire foot. Both feet are to be treated in the same way, even if the skin looks healthy and lesions are present on one foot only.
15747075|NCT04883593|Drug|Placebo Control|The assigned Investigational Product will be applied to the skin between, under, all over the toes, sole and sides of the entire foot. Both feet are to be treated in the same way, even if the skin looks healthy and lesions are present on one foot only.
15747076|NCT04883580|Device|Navigation and Positioning System for Orthopedic Surgeries|"Experimental group: orthopedic surgery navigation system (Tuodao) assisted pedicle screw fixation
~Control group: orthopedic surgery navigation system (tianzhihang) assisted pedicle screw fixation"
15747077|NCT04883567|Diagnostic Test|The use of artificial intelligence system Cerebro|The artificial intelligence system Cerebro would be used during OGD
15747078|NCT04883554|Other|Olfactory therapeutic|The sessions of the olfactory sensory therapy group take place according to the care framework at a frequency of one session of 45 minutes per week
15747079|NCT04883554|Other|Body therapy|very specific stages at a weekly frequency and lasts 1 hour. Kinesic time or time to set the body in motion (20 min) Kinesthetic time: time of slow movements (20 min) Talk time (20 min)
15747080|NCT04883541|Behavioral|yoga and meditation|The pregnant women in the study group were given yoga and meditation classes, which included a total of twenty 10-week lessons, which were done by the researchers as 6-week birth preparation training, and with the onset of the birth action, birth processes were followed in the course of labour period yoga and meditation.
15747081|NCT04883541|Behavioral|Birth preparation training|The control group was only given delivery preparation training for 6 weeks, and the birth processes were followed by routine follow-ups.
15747082|NCT04883528|Drug|Sacubitril / Valsartan Oral Tablet [Entresto]|sacubitril/valsartan (LCZ696) tablet with minimum dose 24/26 mg, maximum dose 97/103 mg twice daily administered orally.
15747083|NCT04883528|Drug|Placebo|sacubitril/valsartan matching placebo tablet with minimum dose 24/26 mg, maximum dose 97/103 mg twice daily administered orally.
15747084|NCT04883515|Dietary Supplement|Oral glutamine supplementation|patient will receive oral glutamine supplementation 10 g Ter In Die during 8 weeks
15747085|NCT04883515|Dietary Supplement|Oral protein powder supplementation|patient will receive oral protein powder supplementation10 g Ter In Die during 8 weeks
15747086|NCT04883515|Procedure|Insulin-resistance evaluation|Homeostasic model assessment of insulin resistance test will be performed at baseline, Week 8 and Week 16
15747343|NCT04881435|Device|Hydrogen gas therapy|Hydrogen gas therapy three times one day for 5 days
15747087|NCT04883515|Procedure|Functional intestinal disorders evaluation|Functional intestinal disorders will be measured by the IBS severity score and feces consistency by Bristol scale at baseline, Week 8 and Week 16
15747088|NCT04883502|Biological|Blood sample collection|A blood sample will be collected at enrollment.
15747089|NCT04883502|Biological|Other biological sample collection|"The following biological samples will be collected during the first surgery:
~1 blood sample
~3 fragments of induced membrane
~1 fragment of periosteum"
15747090|NCT04883502|Diagnostic Test|Surgical waste collection|The pieces of polymethylmethacrylate surgical cement will be collected during the second surgery.
15747091|NCT04883502|Diagnostic Test|Radiological examination and functional exploration|A radiological examination and a functional exploration will be performed 6 weeks, 3 months and 6 months after the first surgery
15747092|NCT04883476|Other|Observation study only|
15747093|NCT04883463|Device|Epidural stimulation|Epidural electrical stimulation implant weekly sessions for 21 months.
15747094|NCT04883450|Diagnostic Test|Magnetic resonance imaging (MRI)|All enrolled participants will undergo magnetic resonance imaging (MRI) at their Baseline and 18-Month follow-up visit
15747095|NCT04883437|Drug|Acalabrutinib|Given PO
15747096|NCT04883437|Biological|Obinutuzumab|Given IV
15747097|NCT04883437|Other|Quality-of-Life Assessment|Ancillary studies
15747098|NCT04883437|Other|Questionnaire Administration|Ancillary studies
15747099|NCT04883424|Behavioral|Diabetes Education Program Based on Health Belief Model|After the application, increase in family support and decrease in blood sugar levels are expected in diabetic patients. Family members' diabetic attitudes are expected to increase.
15747100|NCT04883411|Device|CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System|Two-Level ACDF with CEM-Plate Anterior Cervical Plating System and CEM-Cage Cervical Interbody System
15747101|NCT04883385|Other|medical data collection|collection of medical data from patients' medical records
15747102|NCT04883372|Other|continuous glucose monitoring|a continuous glucose monitoring CGM system through the ETAPES telemedicine program
15747104|NCT04883333|Drug|LEO 153339|LEO 153339
15747105|NCT04883333|Drug|Placebo|Placebo
15747106|NCT04883307|Behavioral|Coaching|Professional development coaching based on a curriculum of positive psychology principles and coaching principles.
15747107|NCT04883307|Behavioral|Wellness resources|Residents in the control group received three emails across the 9 month study period that contained materials related to physician well-being such as personal development and resilience, mindfulness, and work life-integration. Materials included recommended readings, videos, and exercises and were curated by members of the Association of Women Surgeons who were not involved in the coaching program.
15747108|NCT04883294|Diagnostic Test|Electronic Nose|All participants breathed through the Aeonose for five minutes. This device contains metal-oxide sensors that change in conductivity upon reaction with VOCs in exhaled breath. These conductivity changes are input data for machine-learning and used for pattern recognition. A nose clip was placed on the nose of each participant to avoid entry of non-filtered air in the device. Before measuring, the Aeonose was flushed with room air, guided through a carbon filter as well. Failed breath tests were excluded from analysis; the reason for failure was documented.
15747109|NCT04883281|Radiation|Intensity modulated radiation therapy (IMRT) with or without chemotherapy|Intensity modulated radiation therapy (IMRT) with or without chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)
15747110|NCT04883281|Drug|cisplatin, cetuximab, or carboplatin-paclitaxel|chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel)
15747111|NCT04883268|Other|Expand Your Horizon|Expand Your Horizon is an online programme, comprising three 15min writing exercises delivered over the course of 1 week. In each writing exercise, participants are asked to describe the functions of their body, and why those are personally meaningful to them.
15747112|NCT04883255|Drug|10 mg Δ9-tetrahydrocannabinol (THC)|5-day course of orally-administered THC (dronabinol), 10 mg
15747113|NCT04883255|Drug|600 mg cannabidiol (CBD)|5-day course of orally-administered CBD, 600 mg
15747114|NCT04883255|Drug|Placebo|5-day course of orally-administered placebo
15747115|NCT04883242|Drug|Carfilzomib|Given IV
15747116|NCT04883242|Drug|Dexamethasone|Given PO or IV
15747117|NCT04883242|Biological|Isatuximab|Given IV
15747118|NCT04883242|Drug|Pomalidomide|Given PO
15747119|NCT04883229|Device|Halo Neuroscience Neurostimulator|"Experimental: Neurostimulation of 2 milliamps anodal (active) tDCS stimulation for 20 mins during 1 hour speech therapy sessions, 3 times a week for 8 weeks, plus daily homework. Then a washout period of no treatment, followed by a 8 weeks of sham tDCS treatment during 1 hour speech therapy sessions, 3 times a week for 8 weeks, plus daily homework.
~Active comparator: Experimental: Sham tDCS stimulation for 20 mins during 1 hour speech therapy sessions, 3 times a week for 8 weeks, plus daily homework. Then a washout period of no treatment, followed by a 8 weeks of neurostimulation of 2 milliamps anodal (active) sham tDCS treatment during 1 hour speech therapy sessions, 3 times a week for 8 weeks."
15747120|NCT04883203|Drug|Vit-D 0.2 MG/ML Oral Solution [Calcidol]|ARM 1 : Cholecalciferol 200,000 IU / 1 mL .
15747121|NCT04883203|Drug|Physiological Irrigating Solution|ARM 2 : placebo
15747122|NCT04883190|Other|Fulfilling Questionaires|Fulfilling Questionaires PHQ-D (brief) and FSMC
15747123|NCT04883164|Other|Cellular and antibody response to spike antigens of SARS-CoV-2 in both groups in peripheral blood samples|Cellular immunity will be assessed with T-cells and other immune cells that express CD154 or other inflammatory or other markers after stimulation with spike antigens. Antibody immunity will be measured with binding and neutralizing activity of antibodies to spike antigens.
15747153|NCT04882839|Combination Product|psychotherapy assisted psilocybin|psychotherapy for patients while under the influence of psilocybin
15747154|NCT04882826|Drug|Sildenafil film-coated tablet 100 mg|Sildenafil is manufactured by Pharmtechnology LLC, Belarus. Each tablet contains 100 mg of sildenafil.
15747155|NCT04882826|Drug|Viagra® film-coated tablet 100 mg|Viagra® is manufactured by Fareva Amboise, France. Each tablet contains 100 mg of sildenafil.
15747156|NCT04882813|Drug|Dapagliflozin|Dapagliflozin dispensing claim is used as the exposure group.
15747124|NCT04883151|Behavioral|SOFUS pilot program|"The SOFUS pilot program consists of six pre-loss sessions (Program 1) and a further six post-loss sessions (Program 2), which are delivered over a 3-month period. Each session ranges from 1-1.5 hours. Sessions 1 and 6 includes the whole family, sessions 2 and 3 focus on the parents, while sessions 4 and 5 target the children (with parents if the child is <10 years old).
~SOFUS consists of three primary components: i) strengthening COMMUNICATION between parents and children, ii) NORMALIZATION of grief processes (pre and post-lost), and iii) EMOTION REGULATION strategies targeting motivational awareness and regulatory skills in grief management (pre and post-lost).
~Families in Program 1 may be offered Program 2 if the child dies before the entire program has been delivered."
15747125|NCT04883138|Drug|GIGA-2050|Recombinant Hyperimmune Polyclonal Antibody
15747126|NCT04883125|Drug|Pioglitazone 15mg|pioglitazone (7.5-30 mg) once daily plus imatinib 400 mg 6 months
15747127|NCT04883112|Device|Magnetic Tape®|Magnetic tape® is applied without creating any tension over low back
15747128|NCT04883112|Device|Kinesiology Tape|Kinesiology tape is applied without creating any tension over low back
15747129|NCT04883099|Device|APIOC for Presbyopia and APIOC for Presbyopia for Astigmatism|Contact Lenses for Presbyopia
15747130|NCT04883073|Device|Use of Endo App|Use of Endo App
15747131|NCT04883060|Device|midline localizer|a midline localizer device with a laser pointer is used to localize where the midline is likely to be located on the patient head prior to the surgery.
15747132|NCT04883047|Other|holistic birth support strategies|"Holistic Birth Support Strategies are composed of birth-supporting practices that were created by Horn and D'Angelo (2017) within the scope of the Algorithm for Coping with Birth Pain and recommended for coping with labor pain. Holistic Birth Support Strategies; It includes four parameters: physical comfort, emotional comfort, informative support and advocacy."
15747133|NCT04883034|Procedure|adductor canal block in outpatient clinic|perform adductor canal block in outpatient clinic for patient post total knee arthroplasty
15747134|NCT04883034|Drug|Analgesics, etoricoxibe|anaelgetic oral intake
15747135|NCT04883021|Device|Dual Target Theta Burst Stimulation|"TMS treatment will be provided daily for 5 days, then daily for 5 days in week 2, and three times per week (Monday, Wednesday, Friday) in weeks 3 and 4.
~Treatment targeting will occur at the Beam F3 and FP1 scalp regions as defined by the 10-20 EEG system and previous publications. A Magventure MagPro X100 figure-8 coil with theta burst capabilities will be used to deliver the stimulus, including intermittent theta burst stimulation to the DLPFC (2 seconds of 50-Hz triplets delivered at 5 Hz, 8 seconds intertrain interval, 600 total pulses) and continuous theta burst to the MPFC (continuous 50-Hz stimulation triplets, 600 pulses). Stimulation will be delivered at 110% of the resting motor threshold."
15747136|NCT04883008|Device|CorPath GRX with technIQ automated movements enabled (technIQ ON)|"The CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary and vascular procedures.
~TechnIQ automated movements are software-based automation of common maneuvers that interventionalists perform when manipulating catheters, guidewires, and devices by hand. In this group, automated movements will be enabled and used at the discretion of the interventionalist."
15747137|NCT04883008|Device|CorPath GRX with technIQ automated movements disabled (technIQ OFF).|"The CorPath GRX System is intended for use in the remote delivery and manipulation of guidewires and rapid exchange catheters, and remote manipulation of guide catheters during percutaneous coronary and vascular procedures.
~TechnIQ automated movements are software-based automation of common maneuvers that interventionalists perform when manipulating catheters, guidewires, and devices by hand. In this group, automated movements will be disabled."
15747138|NCT04882995|Dietary Supplement|Psyillium fiber|Participants receive 7 days of psyllium fiber dietary supplement prior to scheduled surgery
15747139|NCT04882982|Behavioral|Caria app|App to improve symptoms of menopause
15747140|NCT04882982|Behavioral|Menopause Education|Educational materials about symptoms of menopause
15747141|NCT04882969|Device|Fractionated Thulium laser|LaseMD Lutronic Laser is a 1927-nm fractionated thulium laser, which is better absorbed by water than non-ablative 1,540-nm erbium glass laser energy. The laser energy and power can be customized to target a specific penetration depth and achieve selective photothermolysis in skin while mitigating injury to surrounding tissue. The thermal energy generated by the laser has been shown to facilitate the delivery of kerafactor, which contain hair growth factors to stimulate follicular progenitor cell proliferation and differentiation into follicular keratinocytes to promote hair growth.
15747142|NCT04882956|Drug|intravitreal injection|Brolucizumab-Dbll intravitreal injection
15747143|NCT04882956|Drug|intravitreal injection|Aflipercept intravitreal injection
15747144|NCT04882943|Other|questionnaires|Quality of life questionnaires
15747145|NCT04882930|Procedure|Functional Near-Infrared Spectroscopy (fNIRS)|All participants will undergo Functional Near-Infrared Spectroscopy (fNIRS). The hemodynamic response in CPF will be measured using an Octomon+ system (Artinis). Eight emission and two detector probes will be arranged on the participant's forehead.
15747147|NCT04882904|Device|Actimyo°|Actimyo° is an innovative device intended to be used in a home-based environment. It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle.
15747148|NCT04882891|Device|Actimyo|Actimyo° is an innovative device intended to be used in a home-based environment. It is composed of two watch-like sensors, each containing a magneto-inertial sensors that record the linear acceleration, the angular velocity, the magnetic field of the movement in all directions.The two watches can be worn as wristwatch or placed near the ankle.
15747152|NCT04882865|Device|assist|A custom designed patient wrap will envelope the patient. This will be coupled to a mechanical lift system to facilitate repositioning of the patient (AMMP) Commercially available repositioning sheets will be used for the general care of some study patients
15747161|NCT04882774|Drug|Treprostinil Diolamine|Oral treprostinil 0.125 mg TID titrated as clinically indicated and tolerated to a maximum of 6 mg TID
15747162|NCT04882761|Device|Dental implant|Comparative
15747164|NCT04882735|Drug|Acoramidis|TTR stabilizer administered orally twice daily (BID)
15747165|NCT04882722|Other|Questionnaire|Self-questionnaire reported before the first PPFR session and after the last session
15747166|NCT04882709|Device|Receiver-in-canal hearing aid 1 default|A receiver-in-canal hearing aid developed by the Study Sponsor used with the default settings as specified in the Study Sponsor's fitting software.
15747167|NCT04882709|Device|Receiver-in-canal hearing aid 2|A receiver-in-canal hearing aid developed by another hearing aid manufacturer used with the default settings as specified in the manufacturer's fitting software.
15747168|NCT04882709|Device|Receiver-in-canal hearing aid 1 strategy 1|A receiver-in-canal hearing aid developed by the Study Sponsor used with a modified compression strategy that is expected to improve the sound quality.
15747169|NCT04882709|Device|Receiver-in-canal hearing aid 1 strategy 2|A receiver-in-canal hearing aid developed by the Study Sponsor used with a modified compression strategy that is expected to improve the sound quality.
15747170|NCT04882696|Other|Non-slip socks|Patients will wear non-slip socks during their hospitalization
15747171|NCT04882683|Drug|Prednisone|0.75 mg per kilogram per day for three months
15747172|NCT04882683|Drug|Azathioprine|1 mg per kilogram per day for three months
15747173|NCT04882683|Drug|Adalimumab|40mg every two weeks for three months
15747174|NCT04882683|Biological|umbilical cord blood mononuclear cells|Peripheral intravenous infusion method, infusion of umbilical cord blood mononuclear cell suspension 50ml (cell number 2×10^8).
15747175|NCT04882644|Behavioral|Aerobic Exercise|The subjects conduct an aerobic exercise at 65-80% maximum oxygen consumption three times per week for 60 min/session (including 5 min warm-up and 5 min cool down) with treadmills, ellipticals, and rowing machine. The subjects attend health education sessions (eg, general health knowledge of NAFLD and metabolic diseases, and elements of a healthy lifestyle) monthly in the 12 months.
15747176|NCT04882631|Drug|PBI-100 Topical Cream|A dose of approximately 560 ug (approximately 0.4 mL of each of the three concentrations to 3 different sites) of PBI-100 was applied daily (excluding weekends) to the skin test sites.
15747177|NCT04882631|Drug|Positive Control - Sodium laurel sulfate (SLS)|Approximately 0.4 mL of 0.25% SLS was applied daily (excluding weekends) as a positive control test site.
15747178|NCT04882631|Other|PBI-100 Topical Cream, Vehicle|Approximately 0.4 mL of 0% placebo cream was applied daily (excluding weekends) as a positive control test site.
15747179|NCT04882631|Other|Negative Control|A blank patch was applied daily (excluding weekends) as a negative control test site.
15747180|NCT04882618|Drug|Indocyanine green|indocyanine green application during LRRP to detect positive lymph nodes. ICG will be injected to prostate lobes via csytoscopy
15747181|NCT04882605|Genetic|MHC typing|Allelic genotyping resolution of MHC genes (HLA-A, -B, -C, -DRB1, -DQA1, -DQB1, -DPA1, -DPB1 and -DRB3/4/5) using Illumina technology.
15747182|NCT04882605|Genetic|KIR typing|Allelic genotyping resolution of all 13 KIR genes (KIR2DL1, KIR2DL2/2DL3, KIR2DL4, KIR2DL5A, KIR2DL5B, KIR2DS1, KIR2DS2, KIR2DS3, KIR2DS3/2DS5, KIR2DS4, KIR3DL1/3DS1, KIR3DL2, KIR3DL3), 2 KIR pseudogenes (KIR2DP1 and -3DP1) using Illumina technology.
15747183|NCT04882605|Genetic|Assessment of KIR-based prediction scores|Compiling donor/recipient MHC and KIR typings into 28 major KIR-based prediction scores
15747184|NCT04882592|Device|SCONE|Noninvasive spinal cord neuromodulator
15747185|NCT04882579|Diagnostic Test|Point-of-care-ultrasound examination|"The intervention consists of three ultrasound modalities:
~Cardiac ultrasound assessing signs of right ventricular strain or other obvious pathology.
~Deep venous ultrasound assessing presence of a deep venous thrombus
~Lung ultrasound assessing presence of pulmonary infarctions, pleural effusion, pneumothorax or interstitial syndrome."
15747186|NCT04882566|Other|Paleolithic Diet|Advice to follow Paleolithic Diet for Inflammatory bowel disease Patients
15747187|NCT04882553|Procedure|Diaphragmatic echography|Echography of the diaphragm at the zone of apposition. End-inspiratory and/or end-expiratory thickness of the diaphragm will be measured in M-mode.
15747188|NCT04882553|Procedure|Measurement of esophageal pressure|Pressure will be measured in the lower third of the esophagus using an esophageal balloon and pressure transducer.
15747189|NCT04882553|Diagnostic Test|Registration of respiratory mechanics|Pressures and volumes will be registered by the Fluxmed respiratory monitor (MBMED, Argentina)
15747190|NCT04882540|Drug|brivaracetam|"Pharmaceutical form: Film-coated tablets
~Concentration: 100 mg tablets
~Route of administration: Oral use"
15747191|NCT04882527|Device|Non-invasive brain stimulation|Stimulation will be applied once per subject with one mA for 20 minutes over either the left inferior frontal lobe, the right inferior frontal lobe or the right superior parietal lobe.
15747192|NCT04882527|Device|Sham stimulation|The electrode positions and the attachment procedures correspond to those of real tDCS but the electrical current will only be ramped up to 1 mA and switched off completely after 30 s of stimulation.
15747193|NCT04882514|Biological|p*17-K4S2 (25 µg/mL)|Administer p*17-K4S2 25 μg vaccine at 0, 3, and 6 weeks and evaluate the safety and antibody levels for a total of 6 months after the last injection. All vaccines will be administered intramuscularly
15747194|NCT04882514|Biological|J8-K4S2 (100 µg/mL)|Administer a vaccination schedule of p*17-K4S2 25 μg vaccine at 0, 3, and 6 weeks and evaluate the safety and antibody levels for a total of 6 months after the last injection. All vaccines will be administered intramuscularly
15747195|NCT04882514|Biological|p*17-K4S2 (50 µg/mL)|Administer p*17-K4S2 50 μg vaccine at 0, 3, and 6 weeks and evaluate the safety and antibody levels for a total of 6 months after the last injection. All vaccines will be administered intramuscularly
15747196|NCT04882514|Biological|p*17-K4S2 (100 µg/mL)|Administer p*17-K4S2 100 μg vaccine at 0, 3, and 6 weeks and evaluate the safety and antibody levels for a total of 6 months after the last injection. All vaccines will be administered intramuscularly
15747238|NCT04882228|Drug|Placebo of Venitol Tab.|twice daily for 8 weeks (with Entelon Tab.150mg. It is for the masking.)
15747239|NCT04882228|Drug|Placebo of Entelon Tab.150mg|twice daily for 8 weeks(with Venitol Tab. It is for the masking.)
15747197|NCT04882514|Biological|Rabavert vaccine|Administer the standard Rabavert vaccine at 0, 3, and 6 weeks and evaluate the safety and antibody levels for a total of 6 months after the last injection. All vaccines will be administered intramuscularly. The Rabavert vaccine will be used as a control comparator as it has a similar approved dosing schedule to the investigational vaccines.
15747198|NCT04882501|Other|QUEASEEase aromatherapy quick tab|Once patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed.
15747199|NCT04882501|Other|Placebo product|Once patient complains of nausea above intervention will be administered for 5 minutes and nausea level reassessed.
15747200|NCT04882462|Drug|Nimotuzumab|Nimotuzumab, 400mg, intravenously every 3 weeks, for at least 18 weeks
15747201|NCT04882462|Drug|Sintilimab|Sintilimab, 200mg, intravenously every 3 weeks, for at least 18 weeks;
15747202|NCT04882462|Drug|Chemotherapy drug|Chemotherapy drugs were selected by the investigator, every 3 weeks, for 18 weeks
15747204|NCT04882423|Other|grilled hamburger (7 oz) with no vegetables|Test meal 1: grilled hamburger (7 oz) with no vegetables
15747205|NCT04882423|Other|grilled hamburger (7 oz) with steamed broccoli and Brussels sprouts (3g/kg body weight combined)|Test meal 2: grilled hamburger (7 oz) with steamed broccoli and Brussels sprouts (3g/kg body weight combined)
15747206|NCT04882423|Other|grilled hamburger (7 oz) with steamed parsnips, fresh parsley, and celery sticks (3g/kg body weight combined)|Test meal 3: grilled hamburger (7 oz) with steamed parsnips, fresh parsley, and celery sticks (3g/kg body weight combined)
15747207|NCT04882423|Other|grilled hamburger (7 oz) with steamed broccoli, Brussels sprouts, and parsnips plus fresh parsley and celery sticks (6g/kg body weight combined).|Test meal 4: grilled hamburger (7 oz) with steamed broccoli, Brussels sprouts, and parsnips plus fresh parsley and celery sticks (6g/kg body weight combined).
15747208|NCT04882397|Other|Instrument Assisted Soft Tissue Mobilization|Bilateral Instrument assisted soft tissue mobilization application will be applied in a single session to the trapezius and sternocleideomastoideus muscles.
15747209|NCT04882397|Other|Sham|Bilateral sham Instrument assisted soft tissue mobilization application will be applied in a single session to the trapezius and sternocleideomastoideus muscles.
15747210|NCT04882384|Procedure|Pericapsular Nerve Group Block|This will be a peripheral nerve block.
15747211|NCT04882371|Drug|Chemotherapy|Neoadjuvant Chemotherapy for Breast Cancer
15747212|NCT04882371|Diagnostic Test|Magnetic Resonance Imaging (MRI)|Performed contrasted MRI for evaluate response of neoadjuvant chemotherapy
15747213|NCT04882371|Diagnostic Test|Positron emission tomography - Copmputer Tomography (PET-CT)|Performed contrasted PET-CT for evaluate response of neoadjuvant chemotherapy
15747214|NCT04882358|Device|ALFAPUMP DSR (DIRECT SODIUM REMOVAL) SYSTEM|Infusion of sodium free Dextrose 10% into peritoneal cavity to remove sodium and fluid using principles of peritoneal dialysis; sodium and ultrafiltrate will be evacuated to the bladder by the alfapump
15747215|NCT04882358|Drug|SGLT2 inhibitor|treatment with a standard dose of SGLT-2 inhibitor
15747216|NCT04882345|Drug|Almonertinib|"Almonertinib is a class 1 new drug,the third-generation small molecule EGFR TKI, which can irreversibly and highly selectively inhibit EGFR sensitive mutations (such as exon 19 deletion and L858R mutation) and T790M resistance mutations.
~Patients meeting the criteria for inclusion and exclusion were included in the Almonertinib treatment group and received 110 mg of Almonertinib orally once a day."
15747217|NCT04882332|Other|sampling for diabetes control parameters|Intravenous blood withdrawal for a sample of fasting blood glucose (FBG), 2 hr postprandial blood glucose (2 hr -PPG), fasting lipids {total cholesterol (TC), triglycerides (TAG), low density lipoprotein cholesterol (LDL-C), high density lipoprotein cholesterol (HDL-C)}, glycosylated hemoglobin (Hb A1c) ,fasting insulin level and Vitamin B 12 levels
15747218|NCT04882332|Other|Sampling for vitamin B12 level|Intravenous blood sampling for a sample of vitamin B12 level
15747219|NCT04882319|Drug|HP-5000 Topical Patch|HP-5000, placebo and saline will be administered simultaneously
15747220|NCT04882319|Drug|HP-5000 Placebo Patch|HP-5000, placebo and saline will be administered simultaneously
15747221|NCT04882319|Drug|Saline Patch|HP-5000, placebo and saline will be administered simultaneously
15747222|NCT04882306|Device|Bilateral MARIA scan|After consent has been given, the participant's breast will be fitted by the operator using a clear plastic cup to determine their corresponding MARIA® cup insert size. Once this has been determined, participants will be required to lie prone with their breast pendent through an aperture in the MARIA® patient bed. The cup insert will contain a layer of coupling fluid. The hemispherical cup inserts, and array are brought into contact with the breast. Depending on the patient's breast size, one or more cup inserts may be placed in the array to ensure a good but non-compressing fit between the breast and the system interface. The scan sequence will then be performed, this takes a couple of minutes.
15747223|NCT04882293|Drug|Atorvastatin 20 mg / Fenofibrate 160 mg in fixed dose|1 tablet once a day, 20 mg /160 mg, Orally
15747224|NCT04882293|Drug|Atorvastatin (Lipitor ®)|1 tablet once a day, 20 mg, Orally
15747225|NCT04882280|Behavioral|Light|10 hours of light exposure during the daytime, starting 2 hours after habitual wake time
15747226|NCT04882267|Behavioral|Team and Technology|Subjects will receive access and instruction on multiple home exercise apps. They will receive phone calls once a week from care team members for motivational interviewing to encourage exercise.
15747227|NCT04882254|Procedure|Normothermic machine perfusion|Additional 2h of normothermic machine perfusion of the donor kidney with a red cell based perfusate.
15747228|NCT04882241|Biological|Pembrolizumab|IV infusion
15747229|NCT04882241|Drug|Placebo|IV infusion
15747230|NCT04882241|Drug|Cisplatin|IV infusion
15747231|NCT04882241|Drug|Capecitabine|Oral tablets
15747232|NCT04882241|Drug|5-fluorouracil|IV infusion
15747233|NCT04882241|Drug|Docetaxel|IV infusion
15747234|NCT04882241|Drug|Oxaliplatin|IV infusion
15747235|NCT04882241|Drug|Leucovorin|IV infusion
15747236|NCT04882228|Drug|Entelon Tab.150mg|twice daily for 8 weeks
15747240|NCT04882215|Behavioral|GMT combined with WMU Training|"GMT teaches the use of mental strategies to support sustained attention during complex (multi-step) task performance following an interactive programme. GMT is structured into nine modules, with interactive discussions and homework assignments. It will be conducted on a group basis.
~WMU training consists of computerised working memory updating tasks in which trial accuracy and response time are recorded. Two tasks will be trained: 1. a visuo-spatial Matrix Updating (MU) and 2. a verbal Keep Track (KT). For both training tasks, level of difficulty can be modulated by increasing or decreasing the update level, i.e., the number of updates on each trial."
15747241|NCT04882202|Drug|Acetaminophen|Acetaminophen 1g IV every 6 hours for a weight > 50kg (maximum of 4g per 24 hours) or 15mg/kg every 6 hours for a weight < 50kg (maximum of 75mg/kg per 24 hours)
15747242|NCT04882202|Other|Placebo|Normal saline 100 ml (equal amount of acetaminophen) IV every 6 hours
15747243|NCT04882189|Diagnostic Test|Imaging|Images of the corneal endothelium will be obtained using specular microscopy at 1- and 3-months post cataract surgery.
15747244|NCT04882176|Drug|LM-061|The subjects in each dose level will be administered single oral dose of LM-061 tablet on C0D1, and washout for 5 days. After that, the subjects will be administered multiple oral doses once daily (QD) in continuous 28 days (4 weeks) per treatment cycle, until meet the treatment termination criteria, including disease progression or unaccepted toxicity, etc. After obtaining MTD/RP2D, the Safety Review Committee (SRC) may combine the data of safety, PK, and preliminary efficacy to explore other dosing schedules (such as 3 weeks on and 1 week off).
15747245|NCT04882163|Drug|CC-220|CC-220
15747246|NCT04882163|Drug|Polatuzumab vedotin|Polatuzumab vedotin
15747247|NCT04882163|Drug|Rituximab|Rituximab
15747248|NCT04882163|Drug|Tafasitamab|Tafasitamab
15747249|NCT04882163|Drug|Gemcitabine|Gemcitabine
15747250|NCT04882163|Drug|Cisplatin|Cisplatin
15747251|NCT04882163|Drug|Dexamethasone|Dexamethasone
15747252|NCT04882163|Drug|Bendamustine|Bendamustine
15747253|NCT04882163|Drug|Lenalidomide|Lenalidomide
15747254|NCT04882150|Drug|BMS-986196|Specified dose on specified days
15747255|NCT04882150|Other|Placebo|Specified dose on specified days
15747256|NCT04882137|Behavioral|Education plus Coaching|Providers in Intervention group will receive standard education (1.5 hr CME), a tip sheet on how to manage side effects for quick reference and a number to directly reach a provider experienced with managing etonogestrel side effects with questions regarding how to manage side effects.
15747259|NCT04882111|Behavioral|ALIGN|The ALIGN intervention was developed by the Holding Group, an independent partnership of palliative care-trained social workers. The intervention is theory driven, patient/caregiver centered, addresses palliative care and psychosocial issues, and integrates with health care teams. Working in collaboration with KPCO and Dr. Stacy Fischer (primary mentor), the Holding Group tested the ALIGN intervention in the LTAC and SNF setting (Preliminary Studies). The Holding Group will be the intervention personnel providing psychosocial care that targets communication, goal alignment, and caregiver support.
15747262|NCT04882085|Drug|Zavicefta, Ceftazidime-Avibactam|CAZ-AVI 2.5 g (2 g ceftazidime + 0.5 g avibactam) administered IV as a 2 hour infusion every 8 hours. Dose adjustments are available for participants with CrCL ≤50 mL/min.
15747263|NCT04882085|Drug|Best Available Treatment|main treatment expected to be used as either monotherapy or in combination are colistin, tigecycline, fosfomycin, amikacin, and meropenem
15747264|NCT04882072|Drug|Ustekinumab|Participants will receive IV infusion and SC injection of ustekinumab.
15747265|NCT04882072|Other|Placebo|Participants will receive IV infusion and SC injection of matching placebo.
15747266|NCT04882072|Drug|Glucorticoid Taper Regimen|Glucocorticoid will be administered orally.
15747267|NCT04882046|Other|Blood collection|Blood samples (8ml) at three times of the study: at baseline, 3 hours and 6 hours after treatment
15747268|NCT04882046|Other|Data collection|collection of socio-demographic, clinical and biological data.
15747269|NCT04882033|Drug|Concurrent chemoradiotherapy plus anlotinib|"Anlotinib: for cycle 1-6. P.O; QD; from days 1 to 14 in a 21-day cycle. 8mg in low-dose groups (3 subjects). 10mg in middle-dose groups (3 subjects). 12mg in high-dose groups (3 subjects).
~Chemotherapy:
~For cycle 1/4/5/6. Etoposide 100mg/m2, d1-3, q3w; Cisplatin 25mg/m2 d1-3, q3w. For cycle 2/3. Etoposide 50mg/m2, d1-3, q4w; Cisplatin 25mg/m2 d1-3, q4w.
~Radiotherapy:
~For cycle 2/3.Thoracic radiotherapy dose will be 2.0Gy per day, given 5 days a week, to cumulative dose of 60～66Gy."
15747270|NCT04882020|Diagnostic Test|cortisol, BDNF, s100B, IL-1B, IL-6, IL-10, TNF-alpha|compare both groups and evaluate the severity of obstructive sleep apnea modulates serum levels of inflammatory and neurocognitive markers in elederly.
15747271|NCT04882007|Drug|OSE-127|mAb antagonist to CD127 receptor (or IL-7Rα)
15747272|NCT04882007|Drug|Placebo|Normal saline
15747273|NCT04881994|Drug|Finerenone (BAY94-8862)|Single oral dose of finerenone given as 5 mg immediate release (IR) tablet.
15747274|NCT04881981|Radiation|SCART radiation therapy|We will deliver high dose radiation therapy using SCART method. Beam energies of 6Mv will be used. The high dose SCART therapy will be delivered using LINAC systems, as available and appropriate for each patient. The treatment plan used for each patient will be based on an analysis of the volumetric dose including DVH analyses of the PTV and critical normal structures.
15747275|NCT04881968|Behavioral|Hopewell Hospitalist Video Game|Hopewell Hospitalist is a customized theory-based adventure video game that uses narrative engagement to educate physician players on advance care planning to increase physicians' likelihood of engaging in and billing for ACP conversations.
15747276|NCT04881955|Drug|[14C]-Ecopipam|[14C]-Ecopipam
15747277|NCT04881942|Other|e-Vapor Product A|e-Vapor product
15747278|NCT04881942|Other|e-Vapor Product B|e-Vapor product
15747279|NCT04881942|Other|e-Vapor Product C|e-Vapor product
15747280|NCT04881942|Other|e-Vapor Product D|e-Vapor product
15747281|NCT04881929|Drug|KN026|KN026 in Combination With Docetaxel
15747282|NCT04881903|Behavioral|Mobile Intervention for Suicidal Thoughts (MIST)|This is an interpretation bias modification intervention that is designed to target cognitive factors that contribute to suicide risk. Participants will be instructed to complete at least 5 treatment sessions per week for a period of 4 weeks. Each session takes approximately 10 minutes.
15747283|NCT04881903|Behavioral|Mobile Intervention for Reducing Anger (MIRA)|This is an interpretation bias modification intervention that is designed to target hostile interpretation bias. Participants will be instructed to complete at least 5 treatment sessions per week for a period of 4 weeks. Each session takes approximately 10 minutes.
15747284|NCT04881890|Behavioral|Low-Carbohydrate Diabetes Prevention Program|LC-DPP participants will be instructed to follow ad-libitum very low-carbohydrate, ketogenic diet, which restricts carbohydrate intake (not including fiber) to 20-35 grams per day with the goal of achieving nutritional ketosis. Participants will be encouraged to eat a normal amount of protein (roughly 80-120 grams per day) and to derive the remaining calories from fat. Allowable foods include: meats, fish, poultry, eggs, cheese, seeds, nuts, leafy greens, non-starchy vegetables, and some fruits
15747285|NCT04881877|Device|Synthetic nitrite Condom|The condoms is composed of a synthetic nitrile rubber latex and 170 mm in length and is 53mm wide. It has a teat ended shape and bead retention mechanism at the top. It is pre-lubricated with silicone oil. It has a shelf-life of 5 years and clear and colourless. It is manufactured by Karex Industries. It is currently experimental.
15747286|NCT04881877|Device|Latex and graphene Condom|The condom is composed of a natural rubber latex with graphene. It is 170 mm in length and is 53mm wide. It has a teat ended shape and bead retention mechanism at the top. It is pre-lubricated with silicone oil. It has a shelf-life of 5 years and is greyish in colour. It is manufactured by Karex Industries. It is currently experimental.
15747287|NCT04881877|Device|Standard latex condom|The condoms is composed of a natural rubber latex. It is 180 mm in length and is 53mm wide. It has a teat ended shape and bead retention mechanism at the top. It is pre-lubricated with silicone oil. It has a shelf-life of 5 years and is natural in colour. It is manufactured by Karex Industries. It has World Health Organisation (WHO)/UNFPA, India Drug Control Authority, Conformitè Europëenne (CE) Mark of the European Union, South African Bureau of Standards and US FDA approval
15747288|NCT04881864|Behavioral|Tele-Enhance Fitness|Livestream, instructor-led tele-exercise classes, involving balance, endurance, and strength training
15747289|NCT04881851|Dietary Supplement|Inositol + alpha lipoic acid|Inositol 1000 mg + alpha lipoic acid 400 mg + folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner
15747290|NCT04881851|Dietary Supplement|Inositol|Inositol 1000 mg + folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner
15747291|NCT04881851|Dietary Supplement|Folic acid (placebo comparator)|Folic acid 200 ug: 1 sachet at breakfast and 1 sachet at dinner
15747292|NCT04881838|Drug|P regimen|Dexamethasone 5 mg/m2 Days 1 and 2; 10mg/m2 Day 3 to 5; Cyclophosphamide 200 mg/m2 Days 1 and 2 Intrathecal therapy Day 1
15747293|NCT04881838|Drug|Course A1 + Vin|vinorelbine 25 mg/m2, Day 1 Dexamethasone 10 mg/m2 Days 1 to 5; Methotrexate 3g/m2, 3-hour infusion Day 1; Etoposide 100mg/m2, Days 4 to 5; Ifosfamide 800 mg/m2, Days 1 to 5; Cytarabine 150 mg/m2, q12h Days 4 to 5;
15747294|NCT04881838|Drug|Course B1 +Vin|vinorelbine 25 mg/m2, Day 1; Dexamethasone 10 mg/m2 Days 1 to 5; Methotrexate 3g/m2, 3-hour infusion Day 1; Cyclophosphamide 200 mg/m2, Days 1 to 5; Doxorubicin 25 mg/m2, Days 4 to 5;
15747295|NCT04881838|Drug|Course A2 + Vin|vinorelbine 25 mg/m2, Day 1 Dexamethasone 10 mg/m2 Days 1 to 5; Methotrexate 3g/m2, 3-hour infusion Day 1; Etoposide 100mg/m2, Days 4 to 5; Ifosfamide 800 mg/m2, Days 1 to 5; Cytarabine 150 mg/m2, q12h Days 4 to 5;
15747296|NCT04881838|Drug|Course B2 +Vin|vinorelbine 25 mg/m2, Day 1; Dexamethasone 10 mg/m2 Days 1 to 5; Methotrexate 3g/m2, 3-hour infusion Day 1; Cyclophosphamide 200 mg/m2, Days 1 to 5; Doxorubicin 25 mg/m2, Days 4 to 5;
15747297|NCT04881838|Drug|Course A3 + Vin|vinorelbine 25 mg/m2, Day 1 Dexamethasone 10 mg/m2 Days 1 to 5; Methotrexate 3g/m2, 3-hour infusion Day 1; Etoposide 100mg/m2, Days 4 to 5; Ifosfamide 800 mg/m2, Days 1 to 5; Cytarabine 150 mg/m2, q12h Days 4 to 5;
15747298|NCT04881838|Drug|Course B3 +Vin|vinorelbine 25 mg/m2, Day 1; Dexamethasone 10 mg/m2 Days 1 to 5; Methotrexate 3g/m2, 3-hour infusion Day 1; Cyclophosphamide 200 mg/m2, Days 1 to 5; Doxorubicin 25 mg/m2, Days 4 to 5;
15747299|NCT04881838|Drug|Maintenance therapy|Vinorelbine 25 mg/m2 IV, weekly for 3 consecutive weeks followed by 1-week rest. Totally 80 cycles.
15747300|NCT04881825|Drug|Glepaglutide|Glepaglutide will be delivered in a single-use autoinjector.
15747301|NCT04881812|Device|Drug-Coated Balloons|Percutaneous coronary intervention of residual disease adjacent to a chronic total occlusion with a paclitaxel drug-coated balloon (minimal stenting strategy).
15747302|NCT04881812|Device|Drug-Eluting-Stent|Percutaneous coronary intervention of the chronic total occlusion and residual coronary artery disease with an everolimus-eluting platinum chromium coronary stent (complete stenting strategy).
15747303|NCT04881799|Drug|Phentermine/Topiramate (Qsymia)|Maximum dose of 15 mg/92 mg orally once daily in the morning. The dose will be titrated to this level (described earlier).
15747304|NCT04881799|Drug|Placebo|Daily injection
15747305|NCT04881786|Device|Orthodontic forces|56g force and 224g force
15747306|NCT04881760|Drug|LY3437943|Administered SC
15747307|NCT04881760|Drug|Placebo|Administered SC
15747308|NCT04881747|Drug|Lasmiditan|Administered orally.
15747309|NCT04881734|Other|Overtime pancreaticoduodenectomy|Compared with daytime surgery, the intervention in this study is to work overtime after 17:00 to perform pancreaticoduodenectomy.
15747310|NCT04881721|Procedure|Urethropexy|Suture based (Mesh-free) surgery to stabilize the urethra for the treatment of stress urinary incontinence
15747311|NCT04881708|Device|Remote Monitoring|Subjects assigned to the Remote Care group will receive education from a clinical nurse from Mayo Clinic's Department of Connected Care on use of the equipment as part of Remote Monitoring. The equipment will be shipped along with instructions and Welcome Letter describing the Mayo Clinic Remote Patient Monitoring program. The Remote Patient Monitoring kit includes a digital tablet, a blood pressure cuff, a thermometer, a pulse oximeter, and a weight scale. Subjects will be contacted by phone at the end of the study to be instructed how to return the kit by mail.
15747312|NCT04881695|Other|Questionary patients|"The patients will answer 1 questionnaire consisting of 5 parts :
~General (demographic information)
~Desire for a child
~Hospital Anxiety and Depression scale
~Sexual life
~Additional questions regarding medical care"
15747313|NCT04881695|Other|Questionary controls|"Witnesses will complete 1 survey containing 4 parts:
~General (demographic information)
~Desire to have a child
~Hospital Anxiety and Depression scale
~Sexual life"
15747314|NCT04881682|Device|Immunoadsorption|see arm/group description
15747315|NCT04881682|Biological|Immunoglobulins|see arm/group description
15747316|NCT04881669|Device|obturator|variable bulbs
15747317|NCT04881656|Other|Help is in Your Hands|HIIYH is a set of 16 online educational modules for caregivers of children with social-communication delays or elevated likelihood of ASD.
15747318|NCT04881643|Behavioral|Trauma-focused cognitive behavioural therapy via a digital support|A blended treatment approach to PTSD, blending internet-based CBT with face-to-face sessions with a therapist
15747319|NCT04881630|Behavioral|Automated Mobile Contingency Management (CM)|Financial incentives contingent upon smoking abstinence
15747320|NCT04881630|Other|Standard Care (SC)|Tobacco cessation telephone counseling and combination nicotine replacement therapy (nicotine patches + nicotine gum/lozenges)
15747321|NCT04881617|Behavioral|Lexical Retrieval Training (LRT)|In person or via teletherapy: Participants work on producing spoken and written names of personally relevant target items using a self-cueing hierarchy. Treatment focuses on the use of strategies that capitalize on spared cognitive-linguistic abilities to support word retrieval. The participant completes two (one hour each) sessions per week with a clinician plus daily home practice exercises.
15747322|NCT04881617|Behavioral|Video-Implemented Script Training for Aphasia (VISTA)|In person or via teletherapy: Participants work on producing personally relevant scripts of 4-6 sentences in length. Length and complexity of scripts are individually tailored. The participant completes 30 minutes per day of home practice, during which they speak in unison with a video/audio model of a healthy speaker clearly articulating the scripts. Biweekly (one hour each) sessions with a clinician target clear and accurate script production, script memorization, and conversational usage of scripts.
15747323|NCT04881604|Device|Adjustable Compression Wrap|"Delivery, adaptation and guidance for daily use of the Adjustable Compression Wrap. (Ready Wrap® allows for easy use because to be pre-molded system in inelastic material with self-adjusting compressible components according to the size and shape of the upper limb. Due to its compressive properties, it can be used as therapy to control lymphedema. The material composition is: 61% Nylon, 33% Polyurethane, 6% Elastane (Spandex)).
~The institutional protocol for the lymphedema control phase will be respected, in which the orthosis is used at home for the longest possible period, with only removal for bathing and sleeping; furthermore, skin care and therapeutic exercises for the upper limbs must be performed daily."
15747324|NCT04881604|Device|Compression Sleeve|"Delivery, adaptation and guidance for daily use of the Compression sleeve. (Compression Sleeve is a mesh in the shape of a glove that provides compression on the fabrics needed to help control the volume of the limbs. Traditionally used for stage 2 of compressive therapy. The composition of the material is: 64% Nylon, 36% Elastane (Spandex) ).
~The institutional protocol for the lymphedema control phase will be respected, in which the orthosis is used at home for the longest possible period, with only removal for bathing and sleeping; furthermore, skin care and therapeutic exercises for the upper limbs must be performed daily."
15747325|NCT04881591|Device|Treatment as usual + APP|Participants at this condition will receive the usual medical treatment for their scoliosis but also they will be monitored daily using the Scoliosis Pain Monitor APP. Alarms will be generated in the face of certain preestablished undesired events. Physicians will be asked to call patients and change/stop treatment if an alarm is received.
15747326|NCT04881578|Other|continuous cardiac monitoring before and after transcatheter PFO closure|Data will be assessed from patients with cryptogenic stroke and planned PFO occlusion who undergo the contemporary ICM protocols to search for silent AF
15747327|NCT04881565|Other|Reactive balance training|During each one-hour session, participants will experience 40-50 perturbations (i.e. approximately one perturbation per training minute) during standing and/or walking activities. The perturbations will be applied in any direction (e.g. forwards, sideways, backwards, etc.) To create a perturbation, the researcher will apply unexpected pushes or pulls to a safety harness at waist level. The perturbation will be sufficient in magnitude to elicit a stepping response from the participant. Throughout the session, participants will complete challenging balance tasks, customized to their ability level. Balance tasks will be organized into five categories: stable, quasi-mobile, mobile, unpredictable and participant-selected.
15747328|NCT04881539|Dietary Supplement|Cannabidiol (CBD)|This group will receive an oral dose of CBD (Six Degrees Wellness).
15747329|NCT04881526|Dietary Supplement|D-beta-hydroxybutyrate|Drink containing D-beta-hydroxybutyrate administered at a dose of 395 mg/kg.
15747330|NCT04881526|Dietary Supplement|Placebo|Isocaloric flavored water with medium-chain triglyceride oil.
15747331|NCT04881513|Diagnostic Test|Narrow Band Imaging|Testing the taste buds structure (blood vessels morphology- classified to 5 types) and the number of taste buds per 20mm2, by Narrow Band Imaging technique before and after the operation (one and six months)
15747332|NCT04881513|Diagnostic Test|Tongue sensitivity testing|testing the tongue sensitivity change prior to surgery and after (1 and 6 months) the surgery with two point discrimination test in mm.
15747333|NCT04881513|Other|Qualitiy of life|Testing the patients quality of life before and after (one and six months) the stapes surgery by SF 36 questionnaire
15747334|NCT04881513|Diagnostic Test|Threshold change|Measuring the intraoperative chorda tympani stimulation threshold change at the beginning and at the end of the procedure- surgery
15747335|NCT04881513|Diagnostic Test|Taste|Taste is measured by applying taste strips (sweet, sour, salty, bitter) in 4 concentrations prior to, 1 and 6 months after surgery.
15747336|NCT04881500|Other|Motivational interview|Patients will follow motivational interview (2 individual sessions by phone)
15747337|NCT04881500|Other|Routine Care|Patients will follow routine care
15747339|NCT04881474|Drug|Ibuprofen 800 mg|30-minute lasting iv infusion of 800 mg ibuprofen diluted with 0,9% saline via intravenous route every 6 hours.
15747340|NCT04881461|Drug|5-grass mix SLIT-drops|Sublingual allergy immunotherapy drops, for daily administration
15747341|NCT04881461|Drug|Placebo|Placebo
15747344|NCT04881422|Behavioral|B-HIPE (Brief High Impact Preparatory Experience)|The intervention consists in a one-week intensive rehabilitation in which participants underwent to a multidimensional rehabilitation composed by physical rehabilitation, mental wellbeing, a proper diet and engaging physical activity (a sail course). Digital motivating reinforcements are proposed to the participants with the aim to maintain the correct lifestyle learned in the B-HIPE program.
15747345|NCT04881409|Device|Respiratory support with nasal high-flow (NHF)|Patient with AECOPD is treated with NHF.
15747346|NCT04881409|Device|Respiratory support with non-invasive ventilation (NIV)|Patient with AECOPD is treated with NIV.
15747347|NCT04881396|Biological|Evaluation of the immunogenicity of the vaccine in haemodialysis patients|The immunogenicity of the vaccine will be evaluated at the peak of vaccine response (Day 7 - Day 14 after the second dose) and 6 and 12 months post vaccination, by the evaluation of humoral IgG anti-spike protein response (seroconversion rate, absolute antibody titers, affinity of antibody) and cellular anti SARS-Cov2 response (number, activation capacity, production of interferon gamma of CD4 and CD8 anti sars cov2 specific T cells)
15747348|NCT04881383|Diagnostic Test|OGTT and HbA1c|An investigation form will be given to the patient to attend an approved private laboratory for blood pressure, weight, height, waist and hip circumferences, and a blood test on OGTT, HbA1c, complete blood count (CBC) and lipid profile within three months
15747349|NCT04881357|Other|test mouth rinse (Lacer Oros Acción Integral - new formula, Barcelona, Spain).|The experimental group will use three times daily a provided manual toothbrush with a sodium fluoride dentifrice, followed by the use of the test mouth rinse (Lacer Oros Acción Integral - new formula, Barcelona, Spain).
15747350|NCT04881357|Other|control group|The control group will use three times daily a provided manual toothbrush with a sodium fluoride dentifrice, followed by the use of the control mouth rinse (Lacer Oros Acción Integral - new formula, without active ingredients, Barcelona, Spain).
15747351|NCT04881344|Procedure|laser hemorrhoidoplasty|"Under local anesthetic (or general anesthetic if contraindications to local anesthetic),
~A laser optic fiber connected to a diode platform (Leonardo, Biolitec AG, Jena, Germany) will be applied threw a anoscope. After making a 1-mm opening at the external border of hemorrhoid pocket, the fiber will be introduced in the hemorrhoidal tissue. Several pulses, each lasting for 1.2 s, with a 0.6-s pause between pulses, will be delivered to the tissue.
~As a day-case procedure (or short-stay if medical or social factors precluded ambulatory intervention),
~Postoperative care will consist of: normal diet, bulking laxatives, self-irrigation to the anal wound at six times per day and painkiller. Absence for work certificate will be made for 7 days for each patient and they will be told to return to work and normal daily activities as soon as they felt able."
15747352|NCT04881344|Procedure|mucopexy|"Threw an anoscope, the hemorrhoidal cushion will be sutured using a half-circle (size 26) needle with a 2-0 poliglecaprone (Monocryl®, Ethicon, USA). Then, a continuous suture will be performed on the mucosa of the anal canal, and will terminate above the dentate line. The hemorrhoidal artery will be ligated by this suture. Then, the ligation will be tied to realize the hemorrhoidopexy.
~Same anesthetic technique and postoperative care as the intervention group. As a day-case procedure (or short-stay if medical or social factors precluded ambulatory intervention)."
15747353|NCT04881331|Other|Analysis of electrosurgical smoke.|Patients undergo standard of care surgical removal of the malignant breast tumor. Electrosurgical knife is used to cut tissues according to standard practice. Fraction of the surgical smoke is captured for analysis and video record of the point of view of the surgeon is captured with a head-mounted camera.
15747354|NCT04881318|Other|Waist-High Compression Tights|Waist-high compression tights providing 15-40 mmHg of pressure.
15747355|NCT04881318|Other|Abdominal Compression Garments|Abdominal compression garment compressing the abdomen, buttocks, and upper thighs.
15747356|NCT04881318|Drug|Medications that modulate heart rate and blood pressure|Medications that modulate heart rate and blood pressure that participants regularly take. These medications include beta-blockers, midodrine, ivabradine and stimulants.
15747357|NCT04881305|Diagnostic Test|questionnaires and neuropsychological assessment|Participants will undergo: (1) An evaluation of COVID-19-related symptoms such as fatigue, post-exertional malaise, dizziness, etc. (2) A comprehensive evaluation of behavioral measures (e.g., hearing, vision, olfaction, sleep, social engagement) (3) A short validated neuropsychological evaluation, of multiple cognitive domains, with an emphasis on the memory domain; motivational factors will also be taken into account using performance validity tests (4) A thorough well-being and emotional state assessment, including the evaluation of mood disturbance and quality of life. The assessment will involve both self-report and cognitive tasks, previously associated with psychopathology. In addition to the above-mentioned evaluations, a subgroup of participants will undergo either MRI examination or FDG PET-CT, with the aim of clarifying the neural mechanisms underlying the neurologically-related symptoms.
15747358|NCT04881279|Other|Event|Ransomware attack
15747359|NCT04881240|Biological|CD19-CAR(Mem) T-cells|Allogeneic CD19-CAR.CD45RA-negative T-cells Intravenous infusion
15747360|NCT04881240|Drug|Cyclophosphamide|Cyclophosphamide is a nitrogen mustard derivative. It acts as an alkylating agent that causes cross-linking of DNA strands by binding with nucleic acids and other intracellular structures, thus interfering with the normal function of DNA.
15747361|NCT04881240|Drug|Fludarabine|Fludarabine phosphate is a synthetic purine nucleoside analog. It acts by inhibiting DNA polymerase, ribonucleotide reductase and DNA primase by competing with the physiologic substrate, deoxyadenosine triphosphate, resulting in inhibition of DNA synthesis.
15747362|NCT04881240|Drug|Mesna|Mesna is a synthetic sulfhydryl (thiol) compound. Mesna contains free sulfhydryl groups that interact chemically with urotoxic metabolites of oxaza-phosphorine derivatives such as cyclophosphamide and ifosfamide.
15747363|NCT04881240|Device|CliniMACS|A CliniMACS device is used to select donor T-cells for manufacturing of the memory CAR T-cell product.
15747364|NCT04881240|Procedure|Leukapheresis|Leukapheresis is performed to collect the T cells that are needed to generate the CD19-CAR.CD45RA-negative T-cells product for the clinic study.
15747365|NCT04881227|Device|Chatbot on COVID-19 vaccine hesitancy|This intervention will provide to participants information on COVID-19 vaccine hesitancy consisting of the possibility of accessing a long series of questions and answers online about this vaccination.
15747366|NCT04881227|Other|Control intervention|This control intervention will provide to participants a brief text decribing the way vaccines works.
15748480|NCT04872530|Dietary Supplement|Fava-bean protein concentrate|Fava-bean protein concentrate
15747367|NCT04881214|Other|Pulmonary rehabilitation|pulmonary rehabilitation for 12 weeks, 3 times a week. control will take place at 3, 6 and 12 months
15747368|NCT04881201|Procedure|blood sample|blood sample
15747369|NCT04881188|Diagnostic Test|Survey|Patients with chronic low back pain in in-patient multimodal pain therapy. Three survey times, questionnaires
15747370|NCT04881175|Device|Non-Invasive Treatment|Single-arm group using the FlexSure Applicator device.
15747371|NCT04881162|Device|NOVIS Transcarotid Neuroprotection System (NPS)|The NOVIS Transcarotid Neuroprotection System (NPS) is intended to provide transcarotid vascular access and embolic protection
15747372|NCT04881149|Device|TempSure treatment|Self-controlled, single-arm study using the TempSure device.
15747373|NCT04881136|Device|Reveal LINQ™|The physical device is the Reveal LINQ™, which is a small implantable loop recorder that is used to monitor cardiac parameters at present. The Investigational Falls Prediction RAMware is software that will be downloaded on to the Reveal LINQ™ that will enable it to collect additional sensor information including accelerometer and posture count data that will be used for gait analysis.
15747376|NCT04881110|Drug|Liraglutide|Patients in this arm will receive one daily subcutaneous injection of liraglutide. The starting dose is 0.6 mg/dl per day. The dose has to be increased to 1.2 mg/dl per day after the first week of treatment and to 1.8 mg/dl after the second one.
15747377|NCT04881110|Other|Control|Patients in this arm will be strictly monitored for atherosclerosis major risk factors, such as hypertension and dyslipidemia, and treated according to current clinical practice.
15747378|NCT04881097|Behavioral|no intervention|no intervention
15747379|NCT04881084|Other|Digital storytelling group|Participants (intervention- group 1) will watch digital stories, short videos describing the experience of recovering from mental illness created as part of this project. Participants in the control group (group 2) will watch social marketing and/or fundraising campaigns on similar topics and complete a few questionnaires. The following standardized scales will be used: The Level of Familiarity Scale (LOF) (which will be used only before exposure to movies); Toronto Empathy Questionnaire (16 items; internal consistency coefficient .79; test-retest reliability coefficient .73), Compassionate Love Scale (21 items; Cronbach's alpha: .95; item-to-total correlations ranging from .46 to .81), Dispositional Positive Emotions Scale (DPES) (5 items; Cronbach's alpha for the compassion subscale: .80; inter-scale correlations: .44), Self-Stigma of Mental Illness Scale-Short Form (SSMIS-SF) (20 items; Cronbach's alpha: 0.91); Difference and Disdain Scales for Public Stigma (DDSPS) (9 items).
15747380|NCT04881084|Other|Social marketing/fundraising group|Participants will be randomly assigned to the social marketing/fundraising group (n = 40 participants; 20 Anglophone and 20 Francophone; ages 18-35). Participants will be asked to watch twenty-six social marketing/fundraising videos which will be assessed using a between-subjects design.
15747381|NCT04881071|Device|Scarf|Scarf specifically designed to facilitate mother-neonate skin-to-skin contact
15747382|NCT04881058|Device|RF Non-Invasive Treatment|Self-controlled single-arm group using the PicoSure device.
15747384|NCT04881032|Drug|Polysiloxane Gd-Chelates based nanoparticles (AGuIX)|Four intravenous injections of AGuIX will be delivered. Phase I : Three dose levels may be explored 50 mg/kg, 75 mg/kg and 100 mg/ kg. Phase II : recommended dose
15747385|NCT04881032|Radiation|radiotherapy|60 Gy in 6 weeks
15747386|NCT04881032|Drug|Temozolomide|"Concomitant chemotherapy consists of temozolomide (TMZ) at a dose of 75 mg per square meter per day, given 7 days per week from the first day of radiotherapy until the last day of radiotherapy.
~After a 4 week break after concomitant treatment, patient were then received up to 6 cycles of adjuvant TMZ according to the standard 5-day schedule every 28 days ."
15747387|NCT04881019|Device|Continuous glucose monitoring|Continuous monitoring of blood sugar over a 10-day period.
15747388|NCT04881006|Drug|Dapagliflozin 10 mg tablets|Manufactured by Jiangsu Hansoh Pharmaceutical Group Co., Ltd.
15747389|NCT04881006|Drug|Farxiga® 10 mg tablets|Manufactured by AstraZeneca Pharmaceuticals LP
15747390|NCT04880993|Drug|Dapagliflozin 10 mg tablets|Manufactured by Jiangsu Hansoh Pharmaceutical Group Co., Ltd
15747391|NCT04880993|Drug|Farxiga® 10 mg tablets|Manufactured by AstraZeneca Pharmaceuticals LP
15747392|NCT04880980|Drug|Terbinafine Pill|Double than usual dose of oral terbinafine pills will be used for treatment purpose in one group.
15747393|NCT04880980|Drug|Itraconazole capsule|Double than usual dose of oral itraconazole capsules will be used for treatment purpose in second group.
15747394|NCT04880954|Procedure|Soft Tissue Mobilization|Soft Tissue Mobilization will be provided to participants by Licensed Chiropractor focusing on structures of the lower and upper leg. This will be provided for 20 minutes, once per week for 12 weeks.
15747395|NCT04880954|Other|Rehabilitation|Participants will engage in 20 minutes of prescribed at-home exercise 5 times per week, for 12 weeks.
15747396|NCT04880941|Behavioral|Progressive Relaxation Exercise|In the progressive relaxation technique, the tension and anxiety in skeletal muscles are relatively relieved.
15747400|NCT04880915|Other|surgical smoke affects|The study, experimental type, was conducted to investigate the effects of five different methods on surgical smoke protection.
15747401|NCT04880902|Procedure|sleeve gastrectomy|Laparoscopic sleeve gastrectomy had evident therapeutic effects on preexisting obesity-related comorbidities. All patients were referred for abdominal MSCT with a volumetric assessment of gastric pouch within 1 month of surgery and 1 year postoperatively
15747402|NCT04880889|Drug|BL 3000|capsule 500 mg
15747403|NCT04880889|Drug|Reference Pantogar|capsule
15747404|NCT04880876|Drug|25mg Eluxadoline|Oral Tablets
15747405|NCT04880876|Drug|100mg Eluxadoline|Oral Tablets
15747447|NCT04880564|Drug|CN1, 1mg/kg and CN401, 800mg|CN1(1mg/kg) will be administered on Day 1 of each cycle (once every three weeks) for up to 12 months and CN401(800mg) will be administered orally twice daily.
15747409|NCT04880850|Drug|Insulin icodec|Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 26 weeks
15747410|NCT04880850|Drug|Insulin glargine|Participants will receive subcutaneous (s.c.) injections of insulin glargine once daily for 26 weeks
15747411|NCT04880850|Drug|Insulin aspart|Participants will receive subcutaneous (s.c.) injections of insulin aspart 2-4 times daily for 26 weeks
15747412|NCT04880837|Other|Educational Intervention|Attend educational session
15747413|NCT04880837|Other|Informational Intervention|Receive handouts
15747414|NCT04880837|Other|Survey Administration|Complete surveys
15747415|NCT04880824|Behavioral|Prehabilitation- new form of care|The participants in the intervention group take part in a shared decision-making (SDM) conference to plan the intervention. The therapeutic content of the prehabilitation is defined individually for each patient in the SDM conference. Prehabilitation will be a structured and individually tailored 3-week program.
15747416|NCT04880811|Drug|Afatinib|Afatinib is orally administered at 40mg Qd of each 21 day cycle.
15747417|NCT04880811|Drug|Toripalimab|Toripalimab is given by intravenous infusion at 200mg d1 of each 21 day cycle.
15747418|NCT04880798|Diagnostic Test|124I PET/CT|The first 124I PET/CT was prepared with endogenous thyrotropin 30±10 μIU/mL, and the second 124I PET/CT was prepared with endogenous thyrotropin >100 μIU/mL. The RAI-avidity of the metastases was assessed twice along with the levothyroxine withdrawal by 124I PET/CT scans.
15747419|NCT04880785|Drug|Dolutegravir 50 MG / Lamivudine 300 MG Oral Tablet [Dovato]|change of current antiretroviral treatment to DTG 50 mg/3TC 300 mg QD
15747420|NCT04880772|Other|Prehabilitation|exercise & multivitamin (nutritional/dietary advice)
15747421|NCT04880759|Other|bike desks in the classroom|Children will use bike desks for 13 weeks during school time
15747422|NCT04880746|Drug|BEAC|Semustine, 300 mg/m2，-6d； Etoposide, 100 mg/m2，-5～-2d； Cytarabine, 100mg/m2，q12h，-5～-2d； Cyclophosphamide, 1.5g/m2，-5～-2d
15747423|NCT04880746|Drug|Cladribine combined with BEAC|Cladribine, 6mg/m2，-5～-2d, two hours before Cytarabine Semustine, 300 mg/m2，-6d； Etoposide, 100 mg/m2，-5～-2d； Cytarabine, 100mg/m2，q12h，-5～-2d； Cyclophosphamide, 1.5g/m2，-5～-2d
15747424|NCT04880733|Procedure|Acupuncture for pain management|A manualized acupuncture protocol will be performed by a licensed acupuncturist in the patient's emergency department room.
15747425|NCT04880733|Other|Usual care for pain managment|Patient will receive usual care for pain managment.
15747426|NCT04880720|Other|Blood sampling|Blood sampling - 10mL
15747427|NCT04880707|Drug|Twin block local anesthetic nerve block using standard dental anesthetic|2% lidocaine with 1:100,000 epinephrine is the standard dental local anesthetic in universal use. This drug will be administered as the Twin block local anesthetic nerve block targeting the branches of the mandibular nerve supplying the temporalis and masseter muscles.
15747428|NCT04880707|Other|Twin block with placebo|Instead of the standard dental anesthetic, sterile normal saline will be delivered using the Twin block injection
15747429|NCT04880694|Drug|STC3141|"To receive continuous infusion of STC3141 at rate 58.3mg/hr up to 3 days (72hours).
~Also to receive appropriate standard of care."
15747430|NCT04880694|Drug|STC3141|"To receive continuous infusion of STC3141 at rate 87.5mg/hr up to 3 days (72hours).
~Also to receive appropriate standard of care."
15747431|NCT04880681|Device|Novel needle (18 G, 25 cm with 19 mm sample notch) in a new actuator.|Trans Rectal Ultrasound guided Prostate Biopsy using the assigned needle. Approximately 12 biopsies per patient.
15747432|NCT04880681|Device|Standard Tru Cut biopsy needle (Argon 18G, 25 cm biopsy needle with a 19 mm sample notch) in a standard actuator (Möller Medical Blue RBG-1000-10-1000)|Trans Rectal Ultrasound guided Prostate Biopsy using the assigned needle. Approximately 12 biopsies per patient.
15747433|NCT04880668|Device|Aerosol Box (Splashguard)|The aerosol box is a transparent, plastic cube covering the patient's head and shoulders, with circular access ports on the front of the box allowing for access to manage the airway. An additional four access holes (i.e. two on either side of the box) allow for airway assistants to access the patient airway.
15747434|NCT04880655|Device|WSD|Post debridement and within 24 hours of injury, wound care and WSD applied daily
15747435|NCT04880655|Device|Dressed with bacitracin and petrolatum gauze|Post debridement and within 24 hours of injury, wound care and dressing applied daily
15747438|NCT04880616|Drug|NBI-827104|Capsules for oral administration
15747439|NCT04880616|Drug|Placebo|Capsules matching NBI-827104 for oral administration
15747440|NCT04880603|Device|Restrata Graft|Restrata will be meshed in a 1:2 fashion to allow for egress of serous fluid and minimize risk of fluid collection. Restrata will be applied to the entire wound bed not amenable to primary closure and will be underlaid beneath the surrounding skin edges. A split-thickness skin graft is harvested from patient's thigh at 15:1000 inches and placed on top of the Restrata to cover the entire wound bed. The graft is sutured in place using suture choice of surgeon's preference.
15747441|NCT04880603|Procedure|Standard of Care Skin Graft|Standard of Care Skin Graft
15747442|NCT04880590|Other|Sex intercourse|A heterosexual sexual relationship
15747445|NCT04880564|Drug|CN1, 0.5mg/kg and CN401, 400mg|CN1(0.5mg/kg) will be administered on Day 1 of each cycle (once every three weeks) for up to 12 months and CN401(400mg) will be administered orally twice daily.
15747446|NCT04880564|Drug|CN1, 1mg/kg and CN401, 600mg|CN1(1mg/kg) will be administered on Day 1 of each cycle (once every three weeks) for up to 12 months and CN401(600mg) will be administered orally twice daily.
15747448|NCT04880564|Drug|CN1, 3mg/kg and CN401, 800mg|CN1(3mg/kg) will be administered on Day 1 of each cycle (once every three weeks) for up to 12 months and CN401(800mg) will be administered orally twice daily.
15747449|NCT04880564|Drug|CN1, 10mg/kg and CN401, 800mg|CN1(10mg/kg) will be administered on Day 1 of each cycle (once every three weeks) for up to 12 months and CN401(800mg) will be administered orally twice daily.
15747450|NCT04880551|Radiation|Fluoroscopy|In this study the patient will be exposed to radiation during the fluoroscopy for lungs. There is a small chance of alopecia. There is a rare chance that the patients skin may turn red or be damaged.
15747451|NCT04880538|Procedure|Endoscopic procedure|Endoscopic biopsy of one or more of the following: esophagus, stomach, small bowel, colon, or rectum as part of patient clinical care. Biopsies will be performed during endoscopy or colonoscopy and will be transported to the research laboratory for evaluation.
15747452|NCT04880525|Other|Dietary intervention|In accordance with Turkey Dietary Guidelines, these diet plans were designed to provide 45-60% of energy from carbohydrates, 10-20% from protein, and 20-35 percent from fat.
15747453|NCT04880512|Drug|SYHX 1901 tablets|SYHX 1901, oral tablets, in fasted state
15747454|NCT04880512|Drug|Placebo|Matching placebo, oral tablets, in fasted state
15747455|NCT04880499|Dietary Supplement|Iron plus folic acid, vitamin B2, B6, B12, C, and E|A number of 30 subjects are supplemented with iron plus folic acid, vitamin B2, B6, B12, C, and E daily for 60+/-15 days before orthopedic surgery.
15747456|NCT04880486|Other|Education|Usual pulmonary rehabilitation education and pharmacological therapies, and taught them some limbs exercise, using social application to contact and suggestion giving as supervision.
15747457|NCT04880486|Other|Supervision upper limb weight training exercise with VR|Participant is supervised by physical therapist to conduct upper limb weight training exercise with VR.
15747458|NCT04880473|Device|PrevisEA device|The PrevisEA device is placed and activated on the patient's abdomen immediately post-op (within 1 hour of the completion of surgery) and maintained in position for at least 12 hours, counting the number of times MH4 is detected within a four-minute period at hourly intervals. The device determines the MH4 biomarker counts at each hourly collection point and the data are stored on the device. Under normal conditions, transformations of the data are visualized on the display. For this clinical trial, the display is obscured. Therefore, no value will be displayed for interpretation since this is a non-intervention trial and the device is not intended to affect or influence the standard of care for study participants.
15747459|NCT04880460|Dietary Supplement|Magnesium Glycinate tablet 200mg|Magnesium glycinate tablet 200mg twice daily orally for 8 weeks along with SSRIs
15747460|NCT04880460|Dietary Supplement|Placebo tablet 200mg|Placebo tablet 200mg twice daily orally for 8 weeks along with SSRIs
15747462|NCT04880434|Drug|Fludarabine|Administered intravenously
15747463|NCT04880434|Drug|Cyclophosphamide|Administered intravenously
15747464|NCT04880434|Biological|Brexucabtagene autoleucel|A single infusion of brexucabtagene autoleucel (KTE-X19) anti-CD 19 CAR T cells
15747465|NCT04880395|Drug|Intervention Arm: dolutegravir/lamivudine|1 pill QD
15747466|NCT04880395|Drug|Comparator ARM: TDF/XTC plus Dolutegravir (XTC stand for lamivudine OR emtricitabine)|1 pill of each QD
15747467|NCT04880382|Drug|ICI treatment discontinuation|After achieving objective response between 6 and 12 months after treatment onset, for these patients, first or second line treatment by immune checkpoint inhibitor will be discontinued. Patients will be followed as per standard mangement thereafter
15747468|NCT04880382|Drug|ICI treatment continuation|After achieving objective response between 6 and 12 months after treatment onset, for these patients, first or second line treatment by immune checkpoint inhibitor will be continued until disease progreession or unacceptable toxicity
15747469|NCT04880369|Dietary Supplement|Soy isoflavones|Commercially available dietary supplement (capsule) containing 60 mg isoflavones (genistein, daidzein and glycitein).
15747470|NCT04880369|Dietary Supplement|Lignans|Commercially available dietary supplement (capsule) containing 63 mg lignans (secoisolaricirecinol)
15747471|NCT04880369|Dietary Supplement|Placebo|The placebo capsules are supplied and packaged by Region Hovedstadens Apotek (Denmark) and will contain lactose monohydrate, potato starch, gelatin, magnesium stearate and talc.
15747472|NCT04880356|Other|collection of data|collection of retrospective and prospective data from adult patients with ultra-rare inherited neurological diseases
15747473|NCT04880343|Dietary Supplement|Group (A)|Group that will take a daily dose of the commercial dietary supplement provided by the sponsor, composed of mannose, cran-max and vitamin D for 6 months
15747474|NCT04880343|Dietary Supplement|Group (B)|Group that will take a daily dose of the commercial dietary supplement provided by the sponsor, composed of mannose, cran-max and vitamin D for 3 months
15747475|NCT04880330|Device|Cryo-Auriculotherapy|1 session of cryo-auriculotherapy with device with nitrous oxyde on 15 auricular points.
15747476|NCT04880330|Device|Sham comparator|1 session of cryo-auriculotherapy with device without nitrous oxyde on 15 auricular points.
15747477|NCT04880317|Diagnostic Test|Cardiac Magnetic Resonance|All enrolled patients will undergo a contrast-enhanced CMR examination for the assessment of extracellular volume
15747478|NCT04880317|Diagnostic Test|Additional CT acquisition|All enrolled patients will undergo an additional CT scan at 5 minutes post-contrast injection to evaluate myocardial relative enhancement
15747479|NCT04880317|Diagnostic Test|Blood tests|Patients will undergo blood tests to review hematocrit, Sars-CoV-2 antibody status and cardiac fibrosis biomarkers
15747480|NCT04880304|Other|Soccer Heading|A standardized and reliable soccer heading protocol will be used for the experiment. A triaxial accelerometer embedded in a head-band pocket and positioned directly below the external occipital protuberance (inion) to monitor linear and rotational head accelerations. A JUGS soccer machine will be used to simulate a soccer throw-in with a standardized ball speed of 25mph. The ball speed is similar to when soccer players make a long throw-in from the sideline to mid-field. Soccer players frequently perform this maneuver during practice and games. Subjects will stand approximately 40ft away from the machine to perform the heading. Participants perform 20 standing headers with 1 header per 30 seconds. The subjects will be instructed to direct the ball back toward the JUGS soccer machine in the air.
15747481|NCT04880304|Other|Soccer Heading|A standardized and reliable soccer heading protocol will be used for the experiment. A triaxial accelerometer embedded in a head-band pocket and positioned directly below the external occipital protuberance (inion) to monitor linear and rotational head accelerations. A JUGS soccer machine will be used to simulate a soccer throw-in with a standardized ball speed of 25mph. The ball speed is similar to when soccer players make a long throw-in from the sideline to mid-field. Soccer players frequently perform this maneuver during practice and games. Subjects will stand approximately 40ft away from the machine to perform the heading. Participants perform 20 standing headers with 1 header per 30 seconds. The subjects will be instructed to direct the ball back toward the JUGS soccer machine in the air.
15747482|NCT04880291|Drug|GFB-024|Peripherally acting Cannabinoid-1 receptor inverse agonist monoclonal antibody
15747483|NCT04880291|Drug|Placebo|Matched placebo
15747484|NCT04880278|Drug|Nabilone|Half of the participants (30 individuals) will receive nabilone 1mg. Nabilone will be placed in opaque capsules with dextrose filler and administered by mouth only once (around 120 minutes prior to fMRI scanning).
15747485|NCT04880278|Drug|Placebo|Half of the participants (30 individuals) will receive placebo capsules that are opaque and contain only dextrose. Placebo capsules will be administered by mouth only once (around 120 minutes prior to fMRI scanning).
15747486|NCT04880265|Device|BraveHeart wearable life sensors|Collection of EKG data
15747487|NCT04880239|Procedure|Posterior colpoperineorrhaphy|Patients having a sacralcolpopexy will be randomized to ultra lightweight mesh (Coloplast Restorelle) with posterior colpoperineorrhaphy or the same procedure without the posterior colpoperineorrhaphy
15747488|NCT04880226|Device|Magnetic Resonance Imaging (MRI)|Ongoing evaluations of magnetic resonance imaging (MRI) using the Philips Ingenua 1.5T scanner associated with MRI-guided procedures (e.g. ablations or biopsies) are essential to continued procedure improvement within the newly-built hybrid procedure suite.
15747489|NCT04880213|Drug|M5049|Participants will receive single oral dose of film-coated tablet M5049 at low dose on Day 1 under fasted condition.
15747490|NCT04880213|Drug|M5049|Participants will receive single oral dose of film-coated tablet M5049 at medium dose on Day 1 under fasted condition.
15747491|NCT04880213|Drug|M5049|Participants will receive single oral dose of film-coated tablet M5049 at high dose on Day 1 under fasted condition.
15747492|NCT04880200|Diagnostic Test|POC NAT & Adherence Intervention|The POC NAT test will be the SAMBA Semi-Q HIV test. The adherence intervention will be developed by study staff and tailored for delivery along with the POC NAT results.
15747493|NCT04880187|Drug|AXA1125|AXA1125 administered BID with or without food
15747494|NCT04880187|Drug|Placebo|Matching Placebo administered BID with or without food
15747495|NCT04880174|Diagnostic Test|serological testing|Antibody testing for Sars-COV-2 antibodies in blood.
15747496|NCT04880161|Biological|Ampion|Inhaled Ampion
15747497|NCT04880161|Other|Placebo|Inhaled Placebo
15747498|NCT04880148|Dietary Supplement|Thyme and Honey-based oral spray|4 X Sprays in the oral cavity before, immediately after and 6 hours following the radiotherapy session
15747499|NCT04880148|Dietary Supplement|Placebo oral spray|4 X Sprays in the oral cavity before, immediately after and 6 hours following the radiotherapy session
15747500|NCT04880135|Other|Supervised stretching and strengthening exercise|The structure of the supervised exercise sessions was a warm- up, followed by strengthening and finally stretching. Strengthening exercises will consist of a simple fitness plan of overhead press, push, pull and squat to stand which consist of 4 sets of 15 repetitions while stretching exercises protocol will be duration will be 4 sets of 10 repetitions. The total duration of the protocol will be of 50 to 60 minutes which consists of 10 minutes of warm up, strengthening for 20 to 25 minutes and stretching exercises for 15 to 20 minutes.
15747501|NCT04880135|Other|Home-based stretching and strengthening exercise|The structure of the home based exercise sessions was a warm- up, followed by strengthening and finally stretching. Strengthening exercises will consist of a simple fitness plan of overhead press, push, pull and squat to stand which consist of 4 sets of 15 repetitions while stretching exercises protocol will be duration will be 4 sets of 10 repetitions. The total duration of the protocol will be of 50 to 60 minutes which consists of 10 minutes of warm up, strengthening for 20 to 25 minutes and stretching exercises for 15 to 20 minutes.
15747502|NCT04880122|Diagnostic Test|Dried blood spot and venous blood collection|A paired venous blood and capillary blood sample (dried blood spot) were collected in every participant for validation purpose. Venous blood samples were analyzed using a chemiluminescent microparticle immunoassay ( the Architect i2000sr Plus system, Abbott), as a reference. Dried blood spots (EUROIMMUN, PerkinElmer Health Sciences Inc., Lübeck, Germany) or (Whatman™, GE Healthcare Sciences, Cardiff, UK) were analyzed by means of a SARS-CoV-2 IgG ELISA (EUROIMMUN, PerkinElmer Health Sciences Inc., Lübeck, Germany).
15747505|NCT04880096|Other|eDOL|e-health tool (mobile app for patients and web platform for caregivers in pain clinics)
15747506|NCT04880083|Dietary Supplement|Commercially Available Starter Infant Formula|Study formula is provided in powder form and will be administered orally, ad libitum, via an infant feeding bottle and the volume of formula offered to the infant will be guided by the recommended feeding table for the age group or by physician recommendation. The amount consumed by the infant will vary by each infant's weight and appetite.
15747507|NCT04880070|Device|Shockwave Treatment|Self-controlled, single-arm group using the Shockwave device.
15747508|NCT04880057|Other|Resistance+Aerobic training|"The RT focuses on lower extremity workout, including leg press, hamstring curls, and calf raises. The participants start with intensity at 12 RM and finished with intensity at 8 RM after 3 weeks. There are 8 repetitions, 2 sets for each action. It will take 15 minutes to complete RT.
~The AeT is composed by cycling on stationary bikes in the first week, stepping on steppers in 2nd week, and running on treadmills in the last week. Participants are asked to wear a portable heart rate monitor throughout the experiments. They have to maintain their heart rates in 60%-75% of predicted maximal heart rate (moderate intensity exercise), which has been shown to be benefit on cognition[3]. It took the participants 25 minutes to complete AeT."
15747662|NCT04878809|Other|Escola L'Horitzó|Diagnosis of SARS-CoV-2 infection by rapid antigen detection tests in nasal and nasopharyngeal swabs, in asymptomatic and symptomatic subjects who attend regularly to L'Horitzó school .
15747509|NCT04880057|Other|Agility training|AT program consists of three parts: technical drills, pattern running and reactive agility training. There will be nine sessions over 3 weeks and progress the intensity, complexity or velocity every week.
15747510|NCT04880044|Diagnostic Test|EsoCheck/EsoGuard (EC/EG)|EC is a swallowed capsule on a tethered catheter that obtains a touch sample of the distal esophagus. The obtained sample is placed in a buffer and sent to a diagnostics lab for testing of methylated markers from extracted DNA. EG is a methylated DNA test . A positive EG is associated with Barrett's esophagus at all its stages.
15747511|NCT04880044|Diagnostic Test|Esophago-gastro-duodenoscopy (EGD)|SOC diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum. Tissue samples collected.
15747512|NCT04880031|Drug|BOS-580|BOS-580 will be administered by subcutaneous injection
15747513|NCT04880031|Drug|Placebo|Placebo will be administered by subcutaneous injection
15747514|NCT04880018|Device|Capsular Tension Ring|Experimental group uses Capsular Tension Ring from Eyebright Medical Technology (Beijing) Co., Ltd;control group uses Capsular Tension Ring from Carl Zeiss Medical Technology Co., Ltd
15747515|NCT04880005|Behavioral|Clinical decision support|"Based on the phenotyping and algorithms developed by the hospital specialists at Odense University Hospital and Holbæk Hospital in collaboration with GPs, the individual GPs and their patients will receive individualized recommendations on lifestyle interventions and pharmacological treatments.
~The GPs will receive specific clinical decision support (CDS) recommendations on what drugs to prescribe to each patient based on the phenotyping in accordance with a clinical decision support tool (Cambio) and the updated guidelines at all times (Sparrow 2019). The treatment advice to the GPs will be adjusted annually based on treatment effect, re-phenotyping, and updated knowledge of the treatment of T2D. Furthermore, psychiatric, socioeconomic and/or cultural challenges and other determinants for frailty will be a part of the individualized intervention provided to patients by the GPs, again based on the specialist advice."
15747516|NCT04880005|Behavioral|Digital Lifestyle Coaching|As part of DICTA, the patients are offered a personal health coach (dietician, nurse, occupational therapist, or physiotherapist) through the complex eHealth intervention (Liva). Patients will receive personalized empathic, relation driven coaching on healthy lifestyle on the individual patient's preferences (e.g. increased physical activity, healthier diet, weight loss, smoking cessation, personal goal setting, tailored information, peer to peer support), including optimal pharmacological treatment (Komkova 2019). The collaborative eHealth tool will give health coaches access to patient registered outcome measurements (PRO), information. This forms the basis of the individual coaching and is partly supported by artificial intelligence (AI) to improve the coaching by the health coaches (Holzinger 2016).
15747517|NCT04880005|Behavioral|Integration to Standard Electronic Health Record|Data on physical activity, steps, diet goal fulfillment, smoking status etc., are being provided for GPs in a web-based solution integrated into the GPs' health record system. Integration with the GP system XMO (covering 52% of all Danish GPs) has been finalized.
15747518|NCT04879992|Drug|Esomeprazole|Proton pump inhibitor
15747519|NCT04879992|Drug|Bismuth Potassium Citrate|Gastric mucosal protective drug with anti-H. pylori effect
15747520|NCT04879992|Drug|Tetracycline,Metronidazole|Antibiotics for H. pylori eradication
15747521|NCT04879992|Drug|amoxicillin rifabutin|Antibiotics for H. pylori eradication
15747522|NCT04879979|Behavioral|MAAT|MAAT consists of 8 weekly visits of 45 minutes duration and can be delivered effectively through videoconference technology (Vidyo). Participants will be asked to download the Vidyo App on their mobile phone or tablet. Vidyo is a HIPPA compliant, encrypted software with adequate bandwidth for highest quality videoconferencing intended for telehealth. It is the primary software for UPMC Telemedicine. Survivors are provided a workbook to reinforce learning, mastery and application of skills in daily life covered in each MAAT visit. The workbook provides reading structured within each of the 8 visits with guides for application of strategies as homework
15747523|NCT04879966|Drug|Infliximab|Infliximab was used as induction therapy in UC patients, the maintenance treatment was decided by the researcher
15747524|NCT04879966|Drug|Corticosteroid|Corticosteroids was used as induction therapy in UC patients, the maintenance treatment was decided by the researcher
15747525|NCT04879953|Drug|PIPAC with systemic chemotherapy|PIPAC procedures were performed every 6 to 8 weeks, alternating with systemic chemotherapy, replacing a cycle of intravenous chemotherapy.
15747526|NCT04879953|Drug|Systemic chemotherapy alone|Intravenous chemotherapy
15747529|NCT04879927|Other|Resource Matching|Resource staff involved in the customized resource matching arm of the intervention will include staff from DFCI Patient Services and DFCI Financial Counseling. Financial counseling will support patients with financial resource needs. DFCI Patient Services will provide assistance for all other patient Social Determinants of Health needs.
15747530|NCT04879927|Other|Usual Care|Patients randomized to the control group will receive a pre-existing pamphlet detailing DFCI resources.
15747531|NCT04879914|Dietary Supplement|Butyrate|3 cps/die 300 mg/cps
15747532|NCT04879914|Dietary Supplement|Placebo|3 cps/die 300 mg/cps
15747533|NCT04879901|Diagnostic Test|surface EMG|surface EMG estimation with Carrying backpacks forward or backward
15747534|NCT04879888|Biological|Peptide pulsed Dendritic cell|Intradermal vaccination with peptide-pulsed autologous dendritic cells in 200 µL of patient's serum in six doses weekly after surgery.
15747535|NCT04879875|Device|IscAlert|3 IscAlert sensors in the limb undergoing surgery and two control sensors in the opposite limb are inserted and CO2 is measured continously. IscAlert sensors are removed after end of surgery.
15747536|NCT04879875|Device|IscAlert 72h|3 IscAlert sensors in the limb undergoing surgery and two control sensors in the opposite limb are inserted and CO2 is measured continously. IscAlert sensors are removed 72 hours after end of surgery
15747663|NCT04878809|Other|Escola John Talabot|John Talabot School will provide the incidence of infection by SARS-CoV-2 in order to compare the incidence of infection from L'Horitzó School.
15747541|NCT04879849|Drug|Pembrolizumab|Intravenous infusion.
15747542|NCT04879849|Drug|TAK-676|Intravenous infusion.
15747543|NCT04879849|Radiation|Image-guided radiation therapy|Radiation therapy.
15747544|NCT04879836|Device|Teething Gel|Dosage: application of an even coat of 1mm thickness Frequency: 5 times/day (after main meals and before sleeping) Duration: 4 weeks
15747545|NCT04879836|Device|Teething Ring|The teething ring was filled with a coolant Usage: 5/10 min per time Frequency: 5 times/day Duration: 4 weeks
15747546|NCT04879823|Drug|Dexamethasone|IV Dexamethasone Sodium Phosphate will be prescribed orally at a dose of 0.5mg/kg with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The Dexamethasone will be mixed by the parents with 5mL of pre-packaged cherry syrup
15747547|NCT04879823|Drug|Ibuprofen|Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses. It will be prescribed in liquid suspension form for ease of use in pediatric populations. Subjects or parents will purchase this medication and dosage will be given to subjects in easy-to-understand language.
15747548|NCT04879823|Drug|Acetaminophen|Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours. It will be prescribed in liquid suspension form for ease of use in pediatric populations. Subjects or parents will purchase this medication and dosage will be given to subjects in easy-to-understand language.
15747549|NCT04879823|Drug|Placebo|An equal volume of water will be prescribed to patients (0.5mg/kg) with a max dose of 20mg to be taken the morning of days 2, 4, and 6 post-operatively. The placebo (water) will be mixed by the parents with 5mL of pre-packaged cherry syrup.
15747550|NCT04879810|Procedure|Sigmoidoscopy and biopsy, blood work|Flexible tube up lower colon, blood draws, quality of life questionnaires
15747551|NCT04879797|Other|Implementation of Maternal Safety Bundles|In the second phase, implementation of the bundles will take place. During this phase investigators will conduct quarterly surveys with the health facilities to measure implementation progress, including an index of evidence-based practices. Investigators will conduct surveys with postpartum women to measure their patient experience. Surveys will be conducted using RedCap software. Participants will be given the opportunity to complete the survey online or if they prefer, a research assistant can call them to conduct the survey over the phone. Data on SMM will be collected through PELL
15747552|NCT04879797|Other|Doula Services|Investigators are evaluating doula services that are offered by two doula organizations at three hospitals.
15747553|NCT04879784|Other|No intervention|No intervention
15747554|NCT04879771|Procedure|Receive gastrointestinal endoscopy|patients receive gastrointestinal endoscopy in the morning or afternoon
15748481|NCT04872530|Dietary Supplement|Chickpea protein concentrate|Chickpea protein concentrate
15747555|NCT04879758|Genetic|Genetic Risk Estimate|The genetic risk information includes individual remaining-lifetime and 10-year genetic risk estimates for T2D as well as a dichotomized genetic risk category: 'increased genetic risk' (if their genetic risk is higher than the average population risk) or 'no increased genetic risk' (if their genetic risk is not higher than the average population risk).
15747556|NCT04879758|Other|Genetic Risk Estimate + Fitbit Functions|"The genetic risk information includes individual remaining-lifetime and 10-year genetic risk estimates for T2D as well as a dichotomized genetic risk category: 'increased genetic risk' (if their genetic risk is higher than the average population risk) or 'no increased genetic risk' (if their genetic risk is not higher than the average population risk).
~The two unique Fitbit functions are step goal setting and prompts. Individualized daily step goals will be set to be 10% higher than participants' own baseline Fitbit step counts. The 'Reminder To Move' function of Fitbit will be used as a prompt to remind participants to reduce sedentary time and walk at least 250 steps/hour within a specified timeframe (i.e., from 9am to 10pm in the proposed research). If the user has not accumulated at least 250 steps/hour, a reminder (for example, 150 steps to go) will appear on the Fitbit screen at 10 minutes before the hour (for example, at 10:50 a.m.) and cause the device to vibrate."
15747557|NCT04879745|Other|MyVoice:Rheum|Participants will be given access to MyVoice:Rheum, a web-based decision aid (DA).
15747558|NCT04879745|Other|Pamphlet|Participants in this arm will be given a copy of an existing patient pamphlet
15747559|NCT04879745|Other|Provider Experience|Rheumatologists will take a survey to assess their experiences with MyVoice and/or the pamphlet
15747560|NCT04879732|Device|ACTIS|ACTIS Hip stem
15747561|NCT04879719|Behavioral|Ego-depletion|The surgery video lasts for 9 minutes and participants are asked to suppress their emotions. After the intervention several implicit aggression tests, as well as a task, measuring cognitive performance in general are assessed.
15747562|NCT04879719|Behavioral|Control|The surgery video lasts for 9 minutes and participants in the control group are asked to watch the surgery video without the need to suppress their emotions. Several implicit aggression tests, as well as a task, measuring cognitive performance in general are assessed after the 9 minute video sequence.
15747563|NCT04879706|Other|None planned|No intervention planned
15747564|NCT04879693|Device|Continuous Glucose Monitoring System|Continuous Glucose Monitoring System
15747565|NCT04879680|Procedure|sentinel node detection|Under general anesthesia 5 ml at 2.5mg/ml of Infracyanine ® (Laboratoire SERB; France) were injected circumferentially around the areola. Two ml of patent blue-V dye (Laboratoire Guerbet, Aulney-Sous-Bois, France) were injected in combination in the cohort of patients undergoing the procedure after primary chemotherapy. This was followed by a breast massage to facilitate absorption into the lymph vessels, then the surgical lights were turned off and image were obtained under near-infrared light using a first generation Near Infra Red (NIR) device [K]. Course of subcutaneous lymphatic drainage pathway fluorescence was followed up to where it disappeared to enter to deeper axilla and an incision was performed at that place. Lymphatic duct identification using the NIR camera allowed localization and removal of the sentinel lymph node(s).
15747566|NCT04879667|Procedure|endoscopic management of gastrocutaneous fistula after laparoscopic sleeve gastrectomy|we performed upper GI endoscopy to all cases first to assess the site , size and cause of fistula . we used stents , clips , sutures and ballon dilatation to close the fistula according to size , site and cause of fistula.if the fistula had no track that was proved by CT with oral & I.V contrast , we used the endoscopic stent. if the fistula had track that was proved by CT with oral & I.V contrast , we used the OVASCO clip , endo suturing or ballon. Combined maneuvers may be used like ballon dilation and clipping or ballon dilatation and suturing if there was distal narrowing.
15747567|NCT04879654|Procedure|endoscopic surgery|endoscopic surgery followed by multimodality treatment including radiotherapy,Toripalimab,and/or chemotherapy
15747568|NCT04879641|Behavioral|Exposure|Participants are instructed to plan and track in vivo exposures using an exposure diary. Participants are also instructed to reduce safety behaviors, which are overt or covert acts such as avoiding eye contact or rehearsing sentences to prevent a feared outcome.
15747569|NCT04879641|Behavioral|Attention Training|Participants are trained to reduce self-focused and biased attention. Various audio exercises are introduced in which participants learn to intentionally direct the attention away from themselves (i.e., less private self-consciousness), and to be less alert to potentially dangerous external social stimuli (i.e., less public self-consciousness).
15747570|NCT04879641|Behavioral|Cognitive Restructuring|Participants are instructed to identify and modify dysfunctional and negatively biased assumptions. It includes a thought diary to track negative beliefs in daily routine, alongside with exercises to formulate helpful and adaptive thoughts.
15747571|NCT04879641|Behavioral|Psychoeducation|Participants are delivered detailed evidence-based information on SAD with a focus on maintaining processes (e.g., the vicious circle of negative thoughts and emotions, cognitions, and behaviors associated with the maintenance of SAD). Based on the information provided, participants are encouraged to develop an individual model of their social anxiety symptoms.
15747572|NCT04879628|Drug|SAR441344 IV|Pharmaceutical form: Solution Route of administration: IV infusion
15747573|NCT04879628|Drug|placebo IV|Pharmaceutical form: Solution Route of administration: IV infusion
15747574|NCT04879628|Drug|SAR441344 SC|Pharmaceutical form: Solution Route of administration: SC injection
15747575|NCT04879628|Drug|placebo SC|Pharmaceutical form: Solution Route of administration: SC injection
15747576|NCT04879628|Drug|MRI contrast-enhancing preparations|Pharmaceutical form: Solution Route of administration: IV injection
15747577|NCT04879615|Drug|Alteplase|Patients will receive standard dose intravenous alteplase (0.9 mg per kilogram, the first 10% administered as an initial bolus and the remainder over a 1-hour period, with a maximum dose of 90 mg)
15747578|NCT04879602|Behavioral|suction with bronchoscopy|suction with bronchoscopy
15747579|NCT04879589|Drug|Abiraterone Acetate|ATRS-2002
15747580|NCT04879576|Other|Treatment|Telerehabilitation including pulmonary rehabilitation and posture exercises at 8 weeks in total with 2 sessions per week
15747664|NCT04878796|Diagnostic Test|Serum collection, adverse events collection|Measuring Abs variation at different timepoints compared to baseline. LIAISON SARS-Cov-2 TrimericS IgG and Elecsys anti-SARS-Cov-2 tests will be adopted. The level of Abs will be evaluated at baseline and 30(±7), 180(±7),365(±7)days after the 2nd dose of vaccine
15782463|NCT04593329|Drug|TRAMADOL|Tramadol 50 mg
15747581|NCT04879563|Other|ASCAPE-based follow-up strategy|"Follow-up through ASCAPE platform including AI-based predictions for health-related QoL issues and suggestions for personalized interventions depending on the type of QoL issue that needs to be tackled.
~The ASCAPE-based follow-up strategy includes follow-up through validated QoL questionnaires, wearables for capturing active monitoring data, and mobile apps for answering the questionnaires and capturing potential health-related issues."
15747582|NCT04879550|Diagnostic Test|Antithrombin III|Antithrombin III deficiency causes thrombosis. Is thrombosis in ECMO patients related to Antithrombin III deficiency? Groups with and without thrombosis will be separated and whether it is related to Antithrombin III deficiency will be evaluated.
15747583|NCT04879537|Other|Telemedical support|The nursing homes participating in the project will be equipped with telemedical equipment. This will allow teleconsultations to take place when needed. In addition, an early warning system will be introduced and, within the framework of the teleconsultation, a trained medical assistant can be sent to the care facility if necessary, who can carry out medical activities on site under a physician's delegated instructions. In addition, an electronic patient file will be introduced which can be accessed by the telemedicine physician and the general practitioner.
15747584|NCT04879524|Procedure|Percutaneous infracoccygeal Botulinum toxin injection to puborectalis|"The intervention is an injection of 200 units of Botulinum toxin type A in to the puborectalis muscle under ultrasound guidance.
~In the prone position, the puborectalis muscle will be identified below the coccyx using ultrasound. After skin preparation using 70% Isopropyl Alcohol Pad, and up to 5ml of local anaesthetic (1% lidocaine), an electromyography (EMG) needle will be inserted and the puborectalis muscle stimulated using a current to confirm correct needle position. 200 units of BTXA (Botox, Allergan, Ireland) prepared in 2 ml of saline solution and drawn up using a 2ml syringe. 1ml (100 units) of BTXA solution is injected through the EMG needle into the puborectalis muscle to each side of the midline, achieving a total of 200 units. The needle is withdrawn, and the procedure is complete."
15747585|NCT04879511|Drug|metformin|Oral hypoglycemic drug metformin
15747586|NCT04879511|Drug|Basal/bolus insulin|Basal/bolus insulin
15747587|NCT04879498|Drug|Monolithic zirconia|To assess the clinical performance and survival of posterior monolithic zirconia fixed partial dentures
15747588|NCT04879498|Other|Veneered zirconia|To assess the clinical performance and survival of posterior veneered zirconia fixed partial dentures
15747589|NCT04879498|Other|Metal-ceramic|To assess the clinical performance and survival of posterior metal-ceramic fixed partial dentures
15747590|NCT04879485|Biological|Blood products|Compare two different transfusion strategies against standard transfusion regimen
15747591|NCT04879472|Procedure|Osteosynthesis|The elderly are mainly treated by arthroplasty (total hip replacement or hemiarthroplasty) while the younger age groups, by osteosynthesis either using pins, screws or nails
15747592|NCT04879459|Other|Practical sessions to learn CUS exclusively on volunteers presenting a healthy gallbladder|The study days are 1 day apart for CG and IG but follow the exact same organization. Studytake place on day 0-10-30 (+/-2days). Practical sessions to learn CUS are organized either on volunteers presenting a healthy gallbladder or a pathological gallbladder (sludge, gallstones) (CG), either exclusively on volunteers presenting a healthy gallbladder (IG).
15747593|NCT04879446|Procedure|Concentrated growth factor(CGF)|Concentrated growth factor(CGF) liquid applied to the implant cavity and implant surface.
15747594|NCT04879446|Procedure|Advanced platelet rich fibrin (A-PRF)|Advanced platelet rich fibrin (A-PRF) liquid applied to the implant cavity and implant surface.
15747595|NCT04879446|Procedure|Control side of concentrated growth factor study group|Traditional implant methods applied.
15747596|NCT04879446|Procedure|Control side of advanced platelet rich fibrin study group|Traditional implant methods applied.
15747597|NCT04879420|Drug|Teriparatide|Teriparatide dispensing claim is used as the reference group.
15747598|NCT04879420|Drug|Risedronate|Risedronate dispensing claim is used as the exposure group.
15747599|NCT04879407|Drug|Rivaroxaban|Any rivaroxaban dispensing claim is used as the exposure group
15747600|NCT04879407|Drug|Warfarin|Any warfarin dispensing claim is used as the reference group
15747601|NCT04879394|Other|Hypnosis|4 weekly hypnosis sessions, aiming at pain control and distress management. The 90 min. sessions will be conducted in group format by a doctorate-level psychologist trained in hypnosis. Contents will be detailed on hypnosis protocols to ensure standardization.
15747602|NCT04879381|Other|Sputum samples|During consultation, one expectoration will be performed.
15747603|NCT04879368|Drug|Regorafenib|Oral multi-targeted tyrosine kinase inhibitor (TKI) which targets angiogenic (VEGF, TIE-2), stromal (PDGF-β), and oncogenic (RAF, RET and KIT) receptor tyrosine kinases
15747604|NCT04879368|Biological|Nivolumab|human IgG4 monoclonal antibody inhibitor of PD-1
15747605|NCT04879368|Drug|Docetaxel|"Docetaxel is taxane-derivative chemotherapy drug, used in the treatment of early, locally advanced and metastatic breast cancer. It is an anti-microtubule agent. Other uses are in the treatment of non-small cell lung cancer, advanced stomach cancer, head and neck cancers, soft tissue sarcoma, ovarian cancer, metastatic prostate cancer, etc.
~microtubules, and simultaneously promotes assembly and inhibits disassembly of them"
15747606|NCT04879368|Drug|Paclitaxel|Paclitaxel is one of several cytoskeletal drugs that target tubulin. Paclitaxel-treated cells have defects in mitotic spindle assembly, chromosome segregation, and cell division. Unlike other tubulin-targeting drugs, such as colchicine, that inhibit microtubule assembly, paclitaxel stabilizes the microtubule polymer and protects it from disassembly. Chromosomes are thus unable to achieve a metaphase spindle configuration. This blocks the progression of mitosis and prolonged activation of the mitotic checkpoint triggers apoptosis or reversion to the G0-phase of the cell cycle without cell division
15747607|NCT04879368|Drug|Irinotecan|Camptothecin, one of the four major structural classifications of plant-derived anti-cancerous compounds, is a cytotoxic alkaloid which consists of a pentacyclic ring structure containing a pyrrole (3, 4 β) quinoline moiety, an S-configured lactone form, and a carboxylate form. Irinotecan is activated by hydrolysis to SN-38, an inhibitor of topoisomerase I. This is then inactivated by glucuronidation by uridine diphosphate glucuronosyltransferase 1A1 (UGT1A1). The inhibition of topoisomerase I by the active metabolite SN-38 eventually leads to inhibition of both DNA replication and transcription.
15747665|NCT04878783|Diagnostic Test|CT scan|Patients undergoing CT scan staging for gastric and EJ junction cancer + perioperative chemotherapy (FLOT regimen) , CT scan re-staging and radical gastrectomy or esophagogastrectomy will be enrolled in the study
15747608|NCT04879368|Drug|Trifluridine/Tipracil|The drug consists of the cytotoxin trifluridine and the thymidine phosphorylase inhibitor (TPI) tipiracil. Trifluridine is incorporated into DNA during DNA synthesis and inhibits tumor cell growth. Trifluridine (TFT) is incorporated into DNA by phosphorylation by thymidylate kinase (TK) to TF-TMP; TF-TMP then covalently binds to tyrosine 146 of the active site of thymidylate synthase (TS) inhibiting the enzyme's activity. TS is vital to the synthesis of DNA because it is an enzyme involved in the synthesis of the deoxynucleotide, thymidine triphosphate (dTTP). Inhibition of TS depletes the cell of dTTP and causes accumulation of deoxyuridine monophosphate (dUMP), which increases the likelihood that uracil gets misincorporated into the DNA.
15747609|NCT04879355|Device|Spinal needle (25G)|Fine needle aspiration from thyroid nodules using a 25G spinal needle.
15747610|NCT04879355|Device|Conventional fine needle (25G)|Fine needle aspiration from thyroid nodules using a conventional 25G fine needle
15747611|NCT04879342|Behavioral|VIP Program|This intervention will engage the participants with psychoeducational material once a week. This material will include didactic instruction as well as participant engagement in developmentally appropriate activities.
15747613|NCT04879316|Other|Resting Energy Expenditure measurement|Resting Energy Expenditure measurement using indirect calorimetry
15747614|NCT04879303|Behavioral|Robot-assisted social skill intervention|Social robotics will be used by the instructor to teach social skills to the children with ASD for 12 weekly sessions.
15747615|NCT04879303|Behavioral|Human-only instruction programme on social skill training|The children will receive only the human-delivered training throughout the 12 sessions, with the content and sequence of activities the same as the robotic intervention group.
15747616|NCT04879290|Other|FiO2 0.5|Ten minutes before emergence from general anesthesia, the amount of oxygen delivered from the mechanical ventilator called fractional inspired oxygen (FiO2) is set to 0.5 (50%)
15747617|NCT04879290|Other|FiO2 1|Ten minutes before emergence from general anesthesia, the amount of oxygen delivered from the mechanical ventilator called fractional inspired oxygen (FiO2) is set to 1 (100%)
15747618|NCT04879277|Biological|Blood samples|Plasmatic cytokine and plasmatic CRP assay will be realised using luminex in both arms. IL2, IL10,INF gamma, IL, IL6, ILB, TNF alpha will be analysed.
15747619|NCT04879264|Diagnostic Test|self-rating scale for severity of sleep disorders|Participants report the severity of their sleep disorders on a self-rating scale form 0-10 (0=no sleep disorders, 10= maximum sleep disorders).
15747620|NCT04879264|Diagnostic Test|self-rating scale for distress caused by sleep disorders|Participants report their distress caused by sleep disorders on a self-rating scale form 0-10 (0=no distress, 10= maximum distress).
15747621|NCT04879251|Other|No intervention|No intervention
15747622|NCT04879238|Behavioral|BEING|60 minute yoga session that blends mindfulness techniques
15747623|NCT04879225|Behavioral|Tobacco e-liquids|Marketplace includes tobacco flavored e-liquids
15747624|NCT04879225|Behavioral|Menthol and Tobacco e-liquids|Marketplace includes menthol and tobacco flavored e-liquids
15747625|NCT04879225|Behavioral|Mint, Menthol and Tobacco e-liquids|Marketplace includes mint, menthol and tobacco flavored e-liquids
15747626|NCT04879225|Behavioral|All e-liquid flavors|Marketplace includes fruit, dessert, mint, menthol and tobacco flavored e-liquids
15747627|NCT04879212|Other|PCIA +Acupuncture group:|Acupuncturing bilateral Zusanli (ST36) and Sanyinjiao (SP6)
15747628|NCT04879199|Diagnostic Test|Static stability measurement|"The child stands barefoot on dual force platforms in two (CP: three) different conditions: barefoot and with shoes (CP: and with orthosis). Each condition is recorded three times each lasting for 30s, and 30s rest between them. Both conditions are recorded with and without wearing a headset. The order of conditions (within each Virtual Reality (VR)-condition) is randomized. For each condition, the child rests in a comfortable position for 20s with the heels on the same level and arms hanging at their sides. Between both VR-conditions, the child rests for 120 s."
15747629|NCT04879199|Diagnostic Test|Dynamic stability measurement|"The child walks at their normal walking speed on a 10-m walkway in two (CP: three) different conditions: barefoot and with shoes (CP: and with orthosis). For each condition, at least six error-free trials are recorded. Errors in data may occur due to hidden or lost markers during walking or software interruptions. Both conditions are recorded with and without wearing a headset. The order of conditions (within each VR-condition) is randomized."
15747630|NCT04879186|Procedure|Peripheral endovascular angioplasty|Peripheral endovascular angioplasty - using endovascular techniques to treat peripheral artery occlusive lesions.
15747631|NCT04879173|Device|RS85 Ultrasound device|RS85 Ultrasound device manufactured by Samsung Medison
15747632|NCT04879147|Diagnostic Test|Evalution of thyroid function|Determination of TSH, free T4, free T3, SPINA-GT, SPINA-GD and Jostel's TSH index
15747633|NCT04879134|Drug|Apomorphine Injectable Solution|"Patients will receive the treatment while they are in an OFF period, without the effect of any antiparkinsonian medication. For this study, the initial dose of apomorphine or placebo will be 2 mg. We selected an initial standardized dose based on the pharmacological characteristics of apomorphine. Assessments will be completed 30 and 60 minutes after the initial dose. At 60 minutes from the first dose, a 3 mg dose will be administered, and again, assessments will be completed after 30 and 60 minutes. The total given dosage will be 5 mg. Blood pressure and pulse will be checked every 20 minutes after injections.
~Other Names:
~Movapo"
15747634|NCT04879134|Drug|Placebo|"0.9% saline placebo injection
~Other Names:
~• Saline"
15747635|NCT04879121|Drug|Larotrectinib Sulfate|Given PO
15747666|NCT04878770|Drug|Topical corticosteroids|Topical corticosteroids (TCS) are registered for patients of all ages, and are together with emollients, the pillars in the basic treatment of atopic dermatitis. In this study, patients in both the intervention groups and control group are treated with daily emollients and a TCS of moderate to high potency if needed. Rescue medication with TCS of higher potency may be prescribed if basic therapy is inadequate in controlling AD symptoms.
15747735|NCT04878263|Other|FIL-EAS ic care pathway|Organized care pathway with a maximum 4 working day long conventional hospitalization followed by hospitalization at home with a follow up combining hospital and private practice competences.
15747636|NCT04879108|Other|Physiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation|"Physiotherapy rehabilitation and Transcutaneous Electrical Nerve Stimulation (TENS) group received TENS therapy in addition to physiotherapy rehabilitation after thoracic surgery.
~Physiotherapy and rehabilitation program was started after surgery and it was performed for 30 min, twice a day, 5 day a week. The program was included respiratory and posture exercises, coughing, enhancing mobility.
~Transcutaneous Electrical Nerve Stimulation was performed with the a 2-channel portable TENS device and using disposable electrodes. TENS applied on both sides of the incision line. After surgery, TENS was performed before the Physiotherapy and Rehabilitation for 30 min, twice a day, 5 day a week.
~Patients were evaluated before the surgery and the end of postoperative 5th day."
15747637|NCT04879108|Other|Physiotherapy Rehabilitation|"Physiotherapy and Rehabilitation was performed for 5 days after surgery, twice a day, for 30 min, 5 day a week after thoracic surgery. The program was included respiratory and posture exercises, coughing, enhancing mobility.
~Patients were evaluated before the surgery and the end of postoperative 5th day."
15747638|NCT04879082|Other|Professional course, occupational exposures|"The data collected are the following variables: age, sex, diploma, professional course coded in CITP (International Standard Classification of Professions) and NAF (French Nomenclature of Activities), occupational exposures, smoking, risk factors non-professionals, clinical elements of ILD and elements relating to an occupational disease certificate. This database is anonymized.
~The precise diagnosis of ILD is retained during the multidisiciplinary meeting.
~Occupational exposures are assessed in specialized consultation :
~a first professional interview phase: The professional history is traced, listing the training courses followed and the trades carried out. The questioning is precise and focuses on the different tasks performed, and the products used.
~a second step, where a questionnaire is completed by the doctor: A list of specific substances is offered to the patient, who responds whether or not he thinks he has been exposed to them in his professional past."
15747639|NCT04879056|Diagnostic Test|PIPS 5.1|Scanning of glass slides on PIPS 5.1
15747640|NCT04879043|Drug|HDP-101|HDP-101 is available as lyophilized white powder for preparation of infusion.
15747641|NCT04879030|Drug|Beta-Lactams|The patient was randomized to use beta-lactams antibiotic
15747642|NCT04879030|Drug|Fluoroquinolone|The patient was indicated to use a combination of beta-lactams and fluoroquinolones
15747644|NCT04879004|Drug|Ropivacaine injection|Effect of continuous ESPB performed with Ropivacaine 0,375% infusion, in patients undergoing elective laparoscopic colectomy.
15747645|NCT04878991|Diagnostic Test|Overture Metabolomics Embryo Selection|Patients will have their embryos selected for transfer based on morphology alone. The embryo transfer outcome will be compared to the metabolomics result to determine the NPV and PPV of metabolomics vs implantation.
15747646|NCT04878978|Diagnostic Test|Amniocentesis|Amniocentesis will be used to sample the amniotic fluid for Biofire detection of microorganism and to direct antibiotic treatment
15747647|NCT04878978|Other|Routine care without amniocentesis|Routine clinical care
15747648|NCT04878965|Device|Smartwatch|Smartwatch apparatus to measure strong emotions (e.g., anxiety)
15747649|NCT04878952|Other|Garmin Vivofit Activity Tracker|Activity tracker that is worn on the wrist.
15747650|NCT04878939|Other|Power chain used for anterior segment retraction|Elastomeric chain rendering 160 g/side extending between mini-screw implant and a hook crimped on 0.017- by 0.025-inch stainless steel wire distal to the lateral incisor.
15747651|NCT04878939|Other|T-loop fabricated to perform anterior segment retraction|In the frictionless group, anterior segment retraction was done using closing T-loops fabricated from 0.017- by 0.025-inch titanium molybdenum alloy (TMA) wire rendering comparable retraction force.
15747652|NCT04878926|Procedure|IV midazolam and propofol-based sedation combined with ultrasound-guided, left side TAP block|IV midazolam and propofol-based sedation combined with ultrasound-guided, left side TAP block
15747653|NCT04878926|Procedure|IV midazolam and propofol-based sedation with Local Anesthetic infiltration|IV midazolam and propofol-based sedation with Local Anesthetic infiltration
15747654|NCT04878900|Other|Survey|Survey
15747655|NCT04878887|Procedure|IP-DRA vs IP- PRA|Catetherization approach in plane : distal radial artery VS proximal radial artery
15747656|NCT04878874|Device|Magnetic Tape|Magnetic tape® is applied without creating any tension over low back
15747657|NCT04878874|Device|Kinesiology Tape|Kinesiology Tape is applied without creating any tension over low back
15747658|NCT04878861|Behavioral|Training in the blind field|Participants will complete visual training at two locations in the blind field. These two locations of training will be determined at the baseline study visit (0 months) and will be located within the perimetry-defined blind field. The training programme involves discriminating the direction of motion in a small circle of moving dots. The computer software and a chin-rest will be loaned to each participant to complete training at home. Participants will perform 300 trials at each location in their blind field, 5 days a week for at least 24 weeks (40-60 minutes in total). The computer programme will automatically generate a record of participant performance after each home training session.
15747659|NCT04878848|Other|Proprioceptive Neuromuscular Facilitation Exercises|Within the scope of proprioceptive neuromuscular facilitation exercises, rhythmic initiation, repeated stretch and hold-relax techniques in the upper extremity flexion-abduction-external rotation pattern and scapular patterns of anterior elevation, posterior depression, anterior depression and posterior elevation will be applied to the participants. In addition to these exercises, functional activities in the flexion-abduction-external rotation pattern such as hair combing, turning over from side lying, wearing a jacket, reaching on the shelf will be performed.
15747660|NCT04878848|Other|Conventional Rehabilitation Group|Active assisted / active range of motion exercises and Wand exercises will be applied to the participants in the conventional rehabilitation group for flexion, abduction and external rotation movements. Exercises will be applied as 5 repetitions in the first 2 weeks and 10 repetitions in the last 2 weeks. Strengthening exercises will be performed with an elastic band and free weights. Strengthening exercises will be started as 2 sets of 5 repetitions and at the end of the second week, it will be applied as 2 sets of 10 repetitions. In addition to these exercises, glenohumeral distraction, glenohumeral posterior and caudal glide will be applied for joint mobilization and it will show progression at the end of the second week.
15747661|NCT04878835|Biological|intralesional ranibizumab|Lucentis; Genentech, Inc, San Francisco, California, USA 0.5mg/ 0.05mL
15747667|NCT04878770|Drug|Systemic cyclosporine|"Systemic cyclosporine A (CsA) is an immunosuppressive therapy and is a registered treatment for AD in adults. According to national guidelines, CsA is the first choice for systemic treatment in children with moderate-to-severe AD.
~For CsA a starting dose of 4-5mg/kg/day is administered orally and then tapered down to 2-3mg/kg/day depending on clinical effect. Two doses will be taken at two fixed times per day. Treatment with systemic CsA will be continued for a total of 6 months."
15747668|NCT04878770|Drug|Systemic dupilumab|Dupilumab (DUPIXENT) is indicated for the treatment of children of 6 years and older with moderate-to-sever atopic dermatitis whos disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. DUPIXENT can be used with or without topical corticosteroids. rm: Active Comparator: Systemic dupilumab Dupilumab (DUPIXENT) is administered as a solution by subdermal injection according to national guidelines, based on age and body weight.
15747669|NCT04878757|Behavioral|CFI - Classwide Fraction Intervention|40 sessions (2 sessions per week; 25-31 minutes per session) of explicit fraction intervention designed to improve students understanding of fraction magnitude and fraction operations.
15747670|NCT04878744|Behavioral|Shmapped|Novel app-based intervention to improve wellbeing in patients with common mental health problems.
15747671|NCT04878731|Biological|PF-06741086|single dose SC injection of 300 mg PF-06741086
15747672|NCT04878718|Biological|Fecal Microbiota Transplant; Vancomycin|Subject will be treated with vancomycin followed by fecal microbiota transplant
15747673|NCT04878705|Drug|TWP-201|a single subcutaneous injection
15747674|NCT04878705|Drug|placebo|a single subcutaneous injection
15747675|NCT04878692|Drug|Application of Onco-Rash cream|"The cream Onco-Rash will be administered topically. The patient will be asked to apply the cream twice a day in the morning and evening for 6 weeks to clean, dry skin on selected target areas of the body, namely: the face, the front of the neck, the front of the chest, the back of the neck and the back of the chest. The product penetrates by gentle massage."
15747676|NCT04878692|Drug|Application of Onco-Neutre cream|"The cream Onco-Neutre will be administered topically. The patient will be asked to apply the cream twice a day in the morning and evening for 6 weeks to clean, dry skin on selected target areas of the body, namely: the face, the front of the neck, the front of the chest, the back of the neck and the back of the chest. The product penetrates by gentle massage."
15747677|NCT04878679|Other|Strenght training combined with WB-EMS|Bodyweight exercise training combined with WB-EMS (2 times/week) with a 85Hz electrical impulse
15747678|NCT04878679|Other|Cardiovascular training with WB-EMS|Cardiovascular training , using the rowing machine, combined with WB-EMS (2 times/week) with a 7Hz electrical impulse
15747679|NCT04878679|Other|Control group|No physical activity
15747680|NCT04878653|Device|BACtrack S80 Breathalyzer|The breathalyzer, BACtrack S80 Breathalyzer, will be calibrated per manufacturer's recommendations before each reading will be taken. Participants will administer the breathalyzer test on themselves. They will be instructed on how to hold and blow into the breathalyzer machine.
15747681|NCT04878640|Procedure|patients with morbid obesity and gall bladder stone underwent concomitant laparoscopic cholecystectomy in the same setting during laparoscopic sleeve gastrectomy|patients with morbid obesity and gall bladder stone underwent concomitant laparoscopic cholecystectomy in the same setting during laparoscopic sleeve gastrectomy
15747682|NCT04878640|Procedure|patients with morbid obesity and gall bladder stone underwent laparoscopic sleeve gastrectomy without concomitant laparoscopic cholecystectomy|patients with morbid obesity and gall bladder stone underwent laparoscopic sleeve gastrectomy without concomitant laparoscopic cholecystectomy
15747685|NCT04878614|Drug|Levothyroxine Tablet|Standard clinical management
15747686|NCT04878614|Drug|Levothyroxine Sodium|Liquid levothyroxine through enteral feeding tube
15747687|NCT04878601|Other|Home-Based ART|Healthcare provider will ask ART client for permission to conduct a home visit with their HIV+ partner. Providers will conduct a home visit with HIV+ partners to provide confirmatory HIV testing and ART initiation with a 30-day supply. Monthly home-based ART follow-up visits with male-specific messaging and 30-day supply distribution will take place for 3-months. At 4-months providers will provide assisted linkage to a nearby facility to join the facility-based ART program. Additional counseling will be provided.
15747688|NCT04878601|Other|Facility-Based ART|Healthcare provider will ask ART client for permission to conduct a home visit with their HIV+ partner. Providers will conduct a home visit with HIV+ partners to provide confirmatory HIV testing and assisted linkage to a nearby facility for facility-based ART initiation and continuation. Male clients will receive a 30-day supply each visit and return monthly.
15747689|NCT04878588|Other|patients received high resolution impedance manometry|patients received the above two examination at the same time
15747690|NCT04878575|Other|ASD diagnosis|Autism Diagnostic Interview-revised (ADI-R) and Autism Diagnostic Observation Scale (ADOS)
15747691|NCT04878575|Other|Psychiatric diagnosis|Kiddie Schedule for Affective Disorders & Schizophrenia (K-SADS) for DSM-5
15747692|NCT04878562|Behavioral|I-COPE|The patient survey will be sent out via MyChart 3 days before the visit. It asks about current pain, goals, treatment history, treatment preferences, and health status. Alternatively, patients will be asked to compete a survey in clinic on paper or a tablet. The surveys will be identical, except screening for screening for depression and opioid use will depend on the availability of previous scores. Survey and the EHR will help auto-generate best practice advisories (BPAs) and a tailored smart set. The smartset is based on AGS and CDC guidelines for chronic pain and opioids. It shows which treatment options are not recommended based on the patient's history, comorbidities, and preferences. The smartset also includes links to decision aid and patient education tools. Personalized action plan will be created with pain rating and goal, treatment plan, and relevant tips and educational materials. Action plan will be clearly laid out using max 6 grade reading level, and simple graphics.
15747693|NCT04878549|Diagnostic Test|5-gene transcription signature|This is a prospective multisite diagnostic evaluation study to assess a novel approach to the diagnosis of enteric fever. The index test of host gene transcription responses by a 5 gene-signature will be compared to the reference test of blood culture confirmation for a diagnosis of enteric fever in patients with AUFI.
15747694|NCT04878536|Dietary Supplement|Collagen drink|Testing product
15747698|NCT04878510|Drug|Dexmedetomidine|Dexmedetomidine is an α2-adrenergic agonist sedative commonly used in invasive mechanical ventilation that promotes patient wakefulness, has no effect on respiratory drive, has important analgesic properties, and when compared to γ-aminobutyric acid receptor agonists like benzodiazepines, reduces delirium.
15747699|NCT04878510|Other|Placebo|Normal saline placebo will be given as continuous infusion.
15747700|NCT04878497|Drug|Warfarin|Initiation of warfarin, identified using prescription fill in pharmacy claims
15747701|NCT04878497|Drug|Dabigatran|Initiation of dabigatran, identified using prescription fill in pharmacy claims
15747702|NCT04878497|Drug|Rivaroxaban|Initiation of rivaroxaban, identified using prescription fill in pharmacy claims
15747703|NCT04878497|Drug|Apixaban|Initiation of apixaban, identified using prescription fill in pharmacy claims
15747704|NCT04878497|Drug|Edoxaban|Initiation of edoxaban, identified using prescription fill in pharmacy claims
15747705|NCT04878484|Biological|TCRT-ESO-A2|TCRT-ESO-A2 is an autologous cell therapy comprised of a subject's T cells stimulated ex vivo and transduced with a lentiviral vector encoding an affinity enhanced TCR targeting tumor-associated antigen NY-ESO-1.
15747706|NCT04878471|Drug|ASP5354|Intravenous
15747707|NCT04878471|Drug|Placebo|Intravenous
15747708|NCT04878458|Procedure|phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy|The patients enrolled underwent phacoemulsification with intraocular lens implantation combined with goniosynechialysis and goniotomy.
15747709|NCT04878458|Procedure|phacoemulsification with intraocular lens implantation combined with trabeculectomy|The patients enrolled underwent phacoemulsification with intraocular lens implantation combined with trabeculectomy.
15747710|NCT04878445|Procedure|Patients undergoing standard surgery, excess tissue only will be analysed with patient consent.|Lung samples will be obtained from surplus, healthy margin lung tissue resected from patients with suspected or confirmed lung cancer or from resected tissue from lung volume reduction surgery.
15747711|NCT04878432|Drug|MBG453|Solution for intravenous infusion
15747712|NCT04878432|Drug|Azacitidine|Solution for subcutaneous injection or intravenous infusion
15747713|NCT04878432|Drug|Decitabine|Solution for intravenous infusion
15747714|NCT04878432|Drug|INQOVI (oral decitabine)|Tablet for oral administration
15747715|NCT04878419|Other|Virtual Educational Program|Multiple virtual interactive sessions to provide education/knowledge about Type 1 Diabetes Mellitus care
15747716|NCT04878406|Drug|NNC0480-0389|A single dose of subcutaneous NNC0480-0389. The study will last for a maximum of 72 days.
15747717|NCT04878406|Drug|Placebo (NNC0480-0389)|A single dose of subcutaneous placebo (NNC0480-0389) The study will last for a maximum of 72 days.
15747718|NCT04878406|Drug|Semaglutide|A single dose of subcutaneous Semaglutide 0.5 mg The study will last for a maximum of 72 days.
15747719|NCT04878406|Drug|Placebo (Semaglutide)|A single dose of subcutaneous placebo (semaglutide) The study will last for a maximum of 72 days.
15747720|NCT04878393|Drug|Oral semaglutide|Patients will be treated with commercially available oral semaglutide according to local label and to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study.
15747721|NCT04878380|Device|Sleep tracker|A consumer sleep tracker will be used to monitor sleep patterns throughout the study
15747722|NCT04878380|Behavioral|Sleep education tips|Sleep tips will be provided before the intervention phase
15747723|NCT04878380|Behavioral|Goal-setting|During the intervention phase, the Goal-Setting group will be additionally rewarded for achieving sleep goals, i.e. 30 mins longer than their habitual sleep duration and sleeping before midnight.
15747725|NCT04878354|Drug|SQ tree SLIT-tablet|Sublingual allergy immunotherapy tablets
15747726|NCT04878354|Drug|Placebo|Placebo
15747727|NCT04878341|Other|Erector Spinae Plane Block|The ESP is fascial plane block performed by injecting local anesthetic between the erector spinae muscle and the transverse process. Its proposed mechanism of action is via blockade of the dorsal and ventral rami of the thoracic spinal nerves and sympathetic fibers.
15747728|NCT04878328|Behavioral|Onsite Point-of-care|Guided by Social Cognitive Theory, O-PoC will employ CHWs with lived experience of incarceration to provide: 1) COVID-19 education; 2) SARS-CoV-2 testing with Cepheid XpertXpress PCR tests at Fortune facilities; 3) Needs assessments and facilitated access to masks and hygiene supplies; 4) Navigation to vaccination sites (when available) and single-room housing at Fortune's supportive housing sites and partnering shelters, or alternative strategies that will maximize the ability to socially distance for those who test PCR positive; 5) Supportive counseling.
15747729|NCT04878315|Drug|Capoten|Capoten will be administered per the treatment sequence
15747730|NCT04878315|Drug|Captopril|Captopril will be administered per the treatment sequence
15747731|NCT04878302|Behavioral|Combination of Comprehensive Behavioral Intervention for Tics (CBIT) and Evidence-based interventions for co-occurring diagnoses (i.e., Cognitive Behavioral Therapy, Behavioral Parent Training)|Families assigned to the immediate treatment group will receive the telehealth-based Taming Tics Together protocol(created using well-established, evidence-based treatment protocols), which includes group (parent/caregiver-only, child/teen-only) and individualized one-to-one sessions to address tics and co-occurring diagnoses.
15747732|NCT04878289|Behavioral|TOTAL with Motivational Telemedicine Sessions|Teaching Obesity Treatment Options to Adult Learners Educational Video with 3, 30 minute motivational sessions at 1 week, 6 months, and 12 months after viewing video
15747733|NCT04878276|Device|Dimet 5|The application is carried out according to the enclosed instructions for use.
15747734|NCT04878263|Other|Conventional hospitalization|Conventional care pathway : patients will be hospitalized as long as necessary and then followed according to High Health Authorities recommendations and usual practices.
15747736|NCT04878250|Drug|Bintrafusp alfa|4 doses of bintrafusp alfa (1200mg flat dose) administered intravenously at 14 day intervals before undergoing radical cystectomy.
15747737|NCT04878237|Other|Nasal Secretion Sampling|Nasal specimen collection will be performed at all visits. For every visit specimens will be collected using nasosorption FXi/PU (containing a synthetic absorptive matrix (SAM)), or a 10 cm-long plastic curette (nasosorption devices from Hunt Developments, UK) (Curette devices from Arlington Scientific, USA)
15747738|NCT04878211|Drug|Ofatumumab|3 loading doses followed by monthly administrations
15747739|NCT04878211|Biological|mRNA COVID-19 vaccine|Pfizer or Moderna mRNA Vaccine
15747740|NCT04878211|Drug|interferon or glatiramer acetate|iDMT
15747741|NCT04878198|Behavioral|Jogging program|This intervention consists of 50 sessions of morning jogging sessions at moderate intensity level. Each intervention session will be administered by a trained research assistant assisted by student helpers. All the research staff (i.e. student helpers and research assistant) will be required to attend a workshop (see educational plan) to standardize the procedure on implementing the intervention, as well as handling and motivating their ASD partners. Motivation techniques in previous protocol will be used to enhance the compliance rate.
15747742|NCT04878198|Drug|Melatonin supplement intervention|This intervention is a 10-week melatonin supplement intervention where melatonin supplement will be provided 30 minutes before bedtime.
15747743|NCT04878185|Other|Exercise|Preoperative exercise
15747745|NCT04878146|Procedure|Sacro-spinous fixation|Uterine cervix will be attached to the sacro-spinous ligament
15747746|NCT04878146|Procedure|Subtotal hysterectomy|Done on both arms
15747747|NCT04878146|Procedure|Sacrocolpopexy|Uterine cervix is attached to sacral promontory with two synthetic meshes
15747748|NCT04878133|Diagnostic Test|OCT - optical coherence tomography|"The principle by which OCT works is similar to ultrasound, although light waves close to infrared are used instead of ultrasounds.
~In practice, the light waves, emitted into the vessel through a special catheter positioned in the coronary artery, meet the surrounding structures and are partly absorbed and partly reflected by them. The reflected waves are picked up by a sensor positioned on the catheter and analyzed through software that produces images visible live on a special console."
15747749|NCT04878120|Device|Hybrid Closed Loop Control (USS Virginia) with Smart Bolus Calculator Informed by SI|Hybrid Closed Loop Control (USS Virginia) with Smart Bolus Calculator Informed by SI
15747750|NCT04878120|Device|Standard Hybrid Closed Loop Control (USS Virginia)|Standard Hybrid Closed Loop Control (USS Virginia)
15747751|NCT04878107|Drug|Camrelizumab|Camrelizumab (AiRuiKa™), a programmed cell death 1 (PD-1) inhibitor being developed by Jiangsu Hengrui Medicine Co. Ltd
15747752|NCT04878107|Drug|Apatinib|Apatinib [Aitan® (brand name in China)], also known as rivoceranib, is a novel, small molecule, selective vascular endothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor
15747753|NCT04878107|Drug|Docetaxel injection|"Docetaxel is an anti-cancer (antineoplastic or cytotoxic) chemotherapy drug"
15747754|NCT04878107|Radiation|SBRT|Stereotactic body radiation therapy (SBRT) is a cancer treatment that delivers extremely precise, very intense doses of radiation to cancer cells while minimizing damage to healthy tissue. SBRT involves the use of sophisticated image guidance that pinpoints the exact three-dimensional location of a tumor so that the radiation can be more precisely delivered to cancer cells.
15747755|NCT04878107|Radiation|LDRT|low dose radation therapy
15747756|NCT04878094|Diagnostic Test|Intravenous Indocyanine Green/ICG injection|Intravenous Indocyanine Green/ICG injection will be administered for visualization
15747757|NCT04878094|Diagnostic Test|PINPOINT endoscopic fluorescence imaging system|After resection the surgeon will use the PINPOINT imaging system to assess perfusion of the colonic stump. The intervention will again be used following establishment of the anastomosis, however this time via a proctoscope to visualize the proximal and distal ends of the rectosigmoid anastomosis.
15747758|NCT04878094|Diagnostic Test|Endoscopy|Standard technique and assessment of anastomosis without the use of NIR angiography
15747759|NCT04878081|Behavioral|hot flush|"Hot Flash Diaries to record the change of daily hot flush symptoms for 30 days. The Hot Flash Related Daily Interference Scale to record how much did hot flush effect daily life.
~The Kupperman menopausal index to evaluate the severity of menopausal symptoms. The Pittsburgh Sleep Quality Index to evaluate sleep disorder. Wireless temperature monitor to record hot flush and body temperature during sleeping.
~Classify patients' traditional Chinese constitution by using Physical classification and judgment self-test table."
15747760|NCT04878068|Device|Theram COVID-19 Rapid Antigen Test|The Therma COVID-19 Rapid Antigen Test is an in vitro rapid, lateral flow immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in human saliva specimens. This test is intended for near-patient use at the point-of-care or lay person, self-use in a non-laboratory or home setting using saliva samples from individuals with or without symptoms of COVID-19.
15747761|NCT04878055|Drug|Reparixin|2 tablets of Reparixin (600 mg each), for the total of three daily administrations (6 tablets daily).
15747762|NCT04878055|Other|Placebo|Matched placebo, i.e. 2 tablets for the total of three daily administrations (6 tablets daily).
15747763|NCT04878042|Device|Hydrogen peroxide|Mouth wash and nasal spray 3 times a day for 3 days
15747764|NCT04878042|Device|Placebo|Mouth wash and nasal spray 3 times a day for 3 days
15747765|NCT04878029|Drug|Cabozantinib S-malate|Given PO
15747766|NCT04878029|Drug|Enfortumab Vedotin|Given IV
15747767|NCT04878029|Other|Quality-of-Life Assessment|Ancillary studies
15747768|NCT04878029|Other|Questionnaire Administration|Ancillary studies
15747769|NCT04878016|Biological|ZKAB001|Patients will receive ZKAB001 5mg/kg administered by IV infusion every 21days，
15747770|NCT04878016|Drug|Placebo|Patients will receive placebo administered by IV infusion every 21days.
15747771|NCT04878016|Drug|Carboplatin|Carboplatin should be administered after completion of placebo/ZKAB001 by IV infusion over 30-60 minutes to achieve an initial target AUC of 5 mg/mL/min. Carboplatin and etoposide will be used for a total of 4 cycles， followed by placebo/ZKAB001 maintenance therapy.
15747772|NCT04878016|Drug|Etoposide|"Etoposide (100 mg/m^2) should be administered intravenously over 60 minutes following carboplatin administration. On Days 2 and 3 of each cycle, etoposide 100 mg/m2) should be administered intravenously over 60 minutes.
~Carboplatin and etoposide will be used for a total of 4 cycles， followed by placebo/ZKAB001 maintenance therapy."
15747776|NCT04877964|Device|Ultrasound|Using ultrasound with transverse median and paramedian sagittal oblique approach, the screens that show the target epidural space in the center are obtained and stored for evaluation.
15747777|NCT04877951|Behavioral|LSVT BIG|LSVT BIG is a 4-week program that focuses on movement recalibration for people with a diagnosis of Parkinson's disease.
15747778|NCT04877938|Behavioral|Echolgical physical activity Intervention|'Ecological-Exercise-Intervention'(EEI), would be to limit sitting time to no more than 2 hours/day, and to stand up and move after 30 minutes of continuous sitting. In accordance with several epidemiologic evidences light-intensity activities would be encouraged to substitute sedentary time (e.g., standing up while talking on the telephone, ironing while watching TV).
15747779|NCT04877925|Device|standard chest tubes|2 standard postoperative chest tube used
15747780|NCT04877925|Device|coaxial chest tube|1 postoperative smart drain coaxial tube
15747781|NCT04877912|Diagnostic Test|MRI Abbreviated Scan|"All subjects will be receiving an MRI scan, up to 15 minutes long that includes an injection of contrast agent. This contrast agent will be injected into the arm and will help the doctors to read the MRI more effectively. If there is a lesion (abnormality) in the breast, the contrast agent will go to the lesion first and we will be able to see it better.
~The examination table will then move subject into the magnet, which is a long tube with a diameter of about 3 feet. Subject will be asked to lie in the magnet for about 15 minutes. During the periods when we are taking pictures, we will ask subject to be as still as possible."
15747782|NCT04877912|Diagnostic Test|Abbreviated MRI Scan|"All subjects will be receiving an MRI scan, up to 15 minutes long that includes an injection of contrast agent. This contrast agent will be injected into the arm and will help the doctors to read the MRI more effectively. If there is a lesion (abnormality) in the breast, the contrast agent will go to the lesion first and we will be able to see it better.
~The examination table will then move subject into the magnet, which is a long tube with a diameter of about 3 feet. Subject will be asked to lie in the magnet for about 15 minutes. During the periods when we are taking pictures, we will ask subject to be as still as possible."
15747783|NCT04877899|Device|EchoGo|"EchoGo Core is a stand-alone software application. Echocardiograms should be acquired under the supervision of a physician and standard clinical protocols which includes focused apical 2, 3 and 4 chamber views. The results contain calculated measurements that will be returned to the interpreting physician. These results are intended as an additional input to standard diagnostic pathways and should only be used by a board-certified cardiologist/physician.
~EchoGo Core is intended to be used for the quantification and reporting of results of cardiovascular function to support physician diagnosis. EchoGo Core is indicated for use in adult populations."
15747784|NCT04877886|Diagnostic Test|Ultrasound with IV contrast|To compare the efficiency over the ultrasound scan within contrast
15747785|NCT04877886|Diagnostic Test|CT with IV contrast|CT with IV contrast
15747786|NCT04877886|Diagnostic Test|Ultrasound without IV contrast|Ultrasound without IV contrast
15747787|NCT04877886|Diagnostic Test|CT without IV contrast|CT without IV contrast
15747788|NCT04877873|Behavioral|Gait analysis pre- and post- surgery|None (observational)
15747789|NCT04877860|Other|Multimodal rehabilitation program + PNE (Therapeutic exercise, manual therapy and PNE)|"The sessions will consist of therapeutic exercise in groups: a) warm-up (10 minutes aerobic exercise), b) active mobilizations (cervical / shoulder) c) strength exercises of the cervical and shoulder muscles + general conditioning d) active postural control e) stretching and relaxation exercises.
~4 sessions of myofascial induction.
~Finally, patients will have access to the PaiNEd system before the start of the program (to prepare them for treatment sessions) and during the development of the treatment program in which they will introduce their pain levels and their characteristics and also receive a series of educational advice and recommendations for its improvement."
15747790|NCT04877860|Other|Multimodal rehabilitation program + traditional biomedical information|"The sessions will consist of therapeutic exercise in groups: a) warm-up (10 minutes aerobic exercise), b) active mobilizations (cervical / shoulder) c) strength exercises of the cervical and shoulder muscles + general conditioning d) active postural control e) stretching and relaxation exercises.
~4 sessions of myofascial induction.
~Patients will receive a dossier with traditional biomedical recommendations on pain management and disability associated with the side effects of cancer treatment."
15747791|NCT04877860|Other|Control group|Waiting list of patients who have agreed to participate in the study. They will receive an information dossier with recommendations on pain control and improvement of dysfunction (similar to what was worked on in the experimental group). These recommendations will be distributed at the beginning of the study (initial assessment) and they will be summoned at 8 weeks for the next collection of variables. All patients will be invited to participate in the experimental phase at the end of the control phase.
15747792|NCT04877847|Device|Low-frequency therapeutic ultrasound (LOTUS)|Participants will wear low-frequency therapeutic ultrasound system for procedure. Device will be turned on per normal operating instructions.
15747793|NCT04877847|Device|LOTUS System with Ultrasound Disabled|Participants will wear low-frequency therapeutic ultrasound system for procedure. Device will be turned on and set to Control Setting.
15747794|NCT04877834|Drug|Dexlansoprazole|Dexlansoprazole capsule prepared by SAMI Pharmaceuticals will be administered to this arm.
15747795|NCT04877834|Drug|Dexlansoprazole|Dexlansoprazole capsule prepared by Takeda Pharmaceutical Company will be administered to this arm.
15747796|NCT04877821|Drug|Sintilimab|200mg on days 1 (Q3W) of the neoadjuvant and adjuvant phase of the study; IV injection.
15747797|NCT04877821|Drug|Anlotinib|12mg on d1-14 of Cycles 1-8 (Q3W) of the neoadjuvant phase of the study; po. Arotinib is a small molecule multi-target TKI, which exerts its effect by inhibiting angiogenesis, a critical component of tumour growth and metastasis.
15747798|NCT04877821|Drug|Nab paclitaxel|100 mg/m² on day 1, 8 and 15 of Cycles 1-4 (Q3W) of the neoadjuvant phase of the study; IV injection.
15747799|NCT04877821|Drug|Carboplatin|AUC 5 on days 1 of Cycles 1-4 (Q3W) of the neoadjuvant phase of the study; IV injection.
15747800|NCT04877821|Drug|Epirubicin|90 mg/m² on day of Cycles 5-8 (Q3W) of the neoadjuvant phase of the study; IV injection.
15747801|NCT04877821|Drug|Cyclophosphamide|600 mg/m² on day of Cycles 5-8 (Q3W) of the neoadjuvant phase of the study; IV injection.
15747802|NCT04877795|Diagnostic Test|Blood sampling|Blood will be sampled from enrolled patients and analyzed for levels of troponin, copeptin and heart-type fatty acid binding protein (HFABP).
15747803|NCT04877782|Device|Transcutaneous vagus verne stimulation|Non-invasive and short electrical stimulation by placing the stimulating electrode at the cymba conchae of the left ear. The reference electrode is placed near the left cymba conchae. It provides a light tingling, massaging feeling in the ear.
15747804|NCT04877769|Drug|AT-527|administered twice daily (BID) for 2.5 days (5 doses in total)
15747805|NCT04877756|Drug|OLX10010|Lyophilized cake reconstituted with WFI and injected intradermally
15747806|NCT04877743|Other|None (Observational study)|The main data sources for the study will be participants and their medical records. Vaccination details will be verified by a vaccination card, batch/lot number, and/or using a regional vaccination register. Participants will report all study outcomes using the study app, web portal, or call centre. Participants can also select a proxy to communicate on their behalf: a caregiver, family member, or other trusted individual. Participants will be asked for an emergency contact in case of death or incapacity.
15747807|NCT04877730|Device|Fully Closed Loop (FCL)|Closed loop without a meal anticipation module without announced carbohydrate
15747808|NCT04877730|Device|Fully Closed Loop with meal anticipation module (FCL+)|Closed loop with a meal anticipation module and without announced carbohydrate
15747809|NCT04877730|Device|Hybrid Closed Loop (HCL)|Closed loop without a meal anticipation module with announced carbohydrate
15747810|NCT04877717|Drug|SHR-A1904|SHR-A1904
15747811|NCT04877704|Other|Symprove (probiotic)|Symprove's unique water-based formula is packed full of live, active bacteria. It is a probiotic, not a drug.
15747812|NCT04877704|Other|Placebo|Matched placebo to Symprove probiotic
15747817|NCT04877652|Other|Standard of care|Standard medical treatment of ADHF patients deemed to have insufficient diuretic response.
15747818|NCT04877639|Drug|Esmketamine,Dexmedetomidine|Two different drugs were given to observe which of the two drugs was more suitable for DISE detection
15747819|NCT04877626|Drug|Artemeter plus lumefantrina vs artesunato plus amodiquina|"Group 1 received the combination AQ+AS (COARSUCAM®) which was administered orally at an initial dose of 2 tablets (200 mg AQ/540 mg AS) followed by 2 additional doses of 2 tablets at 24 and 48 hours (6 tablets in 48 hours).
~Group 2 received the combination Artemeter+lumefantrina (COARTEM®) administered orally at an initial dose of 4 tablets (80 mg artemeter/480 mg lumefantrina) followed by 5 additional doses of 4 tablets at 8, 24, 36, 48, and 60 hours (24 tablets in 60 hours)"
15747820|NCT04877613|Drug|single dose of CART-GFRa4 cells|Intravenous infusion of lentiviral transduced autologous T cells that have been engineered to express an extracellular single chain antibody (scFv) with specificity towards GFRa4 with fludarabine and cyclophosphamide.
15747821|NCT04877613|Drug|Fludarabine|Lyphodepletion
15747822|NCT04877613|Drug|Cyclophosphamide|Lyphodepletion
15747823|NCT04877600|Other|dual task performance|dual task performance measurement
15747824|NCT04877587|Drug|Ascorbate|"A patient-individualized pharmacokinetically-guided dose escalation design will be used for Ascorbate. The goal of the within-patient dose escalation is to achieve a target plasma ascorbate level between 20mM and 30mM. The administered dose levels under consideration are listed below.
~Dose Level Ascorbate
~2 60 g/m2 IV Days (1,2,8,9,15,16)
~1 50 g/m2 IV Days (1,2,8,9,15,16) 0 (Starting dose) 40 g/m2 IV Days (1,2,8,9,15,16)
~1 30 g/m2 IV Days (1,2,8,9,15,16)"
15747825|NCT04877587|Drug|Gemcitabine|Gemcitabine 900 mg/m2 given at a fixed dose rate of 10 mg/m2/min on D1, D8 and D15 to be given over 90 min every 28 days
15747826|NCT04877574|Procedure|ANI-guided intraoperative analgesia|Intraoperative analgesia is performed by controlling the effect-site concentration of remifentanil to maintain 50-70 of ANI.
15747827|NCT04877574|Procedure|Conventional intraoperative analgesia|Intraoperative analgesia is performed by controlling the effect-site concentration of remifentanil at the discretion of attending anesthesiologists based on hemodynamic parameters.
15747828|NCT04877548|Other|Fermented orange flour|Volunteers will have to consume a standardized breakfast including fermented orange flour and presenting 50g of available carbohydrates
15747829|NCT04877548|Other|Fermented grape flour|Volunteers will have to consume a standardized breakfast including fermented grape flour and presenting 50g of available carbohydrates
15747830|NCT04877548|Other|Control|Volunteers will have to consume a standardized breakfast without fermented flour but also presenting 50g of available carbohydrates
15747831|NCT04877535|Device|ML-based report card|PACU and ward providers caring for participants will be notified by Anesthesia Control Tower clinicians before arrival if the patient's report card. The notification will contain a report card of the patient's forecast risk of major adverse events, explanatory machine-learning outputs, most influential pre- and intraoperative data, and predicted treatments.The ML risk profile generated for each patient will include risk of 30 day mortality, risk of respiratory failure, risk of acute kidney injury, and risk of postoperative delirium
15747832|NCT04877522|Drug|Asciminib single agent|Taken orally, twice daily, in fasting state
15747833|NCT04877522|Drug|Asciminib|Taken orally, once daily, in the morning with low-fat meal
15747834|NCT04877522|Drug|Imatinib|Taken orally, once daily, in the morning with low-fat meal
15747835|NCT04877522|Drug|Nilotinib|Taken orally, twice daily, on an empty stomach
15747836|NCT04877522|Drug|Bosutinib|Taken orally, once daily, with food
15747837|NCT04877522|Procedure|ECG|Participants on bosutinib that intend to switch to asciminib need to perform ECGs to evaluate the QTcF
15747838|NCT04877522|Procedure|Pregnancy test|All pre-menopausal women who are not surgically sterile will have a serum pregnancy testing performed at each study visit and monthly urine tests to be performed at home.
15747839|NCT04877509|Biological|Selenium, Zinc and Copper, Vitamin A, D, E plasma concentrations during patient hospitalization|Micronutrient assays on heparinized plasma.
15747840|NCT04877496|Drug|History of exposure to anti-CD20 treatment since 01/01/2010|Intravenous treatment history of anti-CD20 treatment since 01/01/2010
15747841|NCT04877496|Biological|Completion of COVID19 vaccine at least 4 weeks ago|Completion of COVID19 vaccination course at least 4 weeks ago.
15747842|NCT04877483|Procedure|Acupuncture|Acupuncture is a form of treatment that inserting very thin needles through a person's skin at specific points on the body. Group GB20 and Group GB20 plus BL2 will received the acupuncture treatment.
15747843|NCT04877483|Diagnostic Test|Proteomics|Group GB20, Group GB20 plus BL2 and Healthy control will take the Proteomics analysis.
15747844|NCT04877483|Diagnostic Test|Oral microbiota|Group GB20, Group GB20 plus BL2 and Healthy control will take the oral microbiota analysis.
15747845|NCT04877483|Diagnostic Test|Schirmer's test|Group GB20 and Group GB20 plus BL2 will take the Schirmer's test.
15747846|NCT04877483|Diagnostic Test|Tear breakup time|Group GB20 and Group GB20 plus BL2 will take the tear breakup time test.
15747847|NCT04877483|Diagnostic Test|6-GSI(six item Gastrointestinal Severity Index)|Group GB20 and Group GB20 plus BL2 will take the 6-GSI test.
15747848|NCT04877483|Diagnostic Test|OSDI(Ocular Surface Disease Index)|Group GB20 and Group GB20 plus BL2 will take the OSDI test.
15747849|NCT04877483|Diagnostic Test|TCM pattern|Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine pattern diagnosis.
15747850|NCT04877483|Diagnostic Test|Traditional Chinese Medicine (TCM) tongue diagnosis|Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine(TCM) tongue diagnosis.
15747851|NCT04877483|Diagnostic Test|TCM pulse diagnosis|Group GB20, Group GB20 plus BL2 and Healthy control will take the Traditional Chinese Medicine(TCM) pulse diagnosis.
15747852|NCT04877483|Diagnostic Test|TCM heart rate variability|Group GB20, Group GB20 plus BL2 and Healthy control will take the TCM Heart rate variability.
15747853|NCT04877483|Diagnostic Test|ESSPRI(EULAR Sjögren's Syndrome Patient Reported Index)|Group GB20 and Group GB20 plus BL2 will take the ESSPRI.
15747854|NCT04877483|Diagnostic Test|Whole-genome genotyping(TWBv2.0)|Group GB20, Group GB20 plus BL2 and Healthy control will take the Whole-genome genotyping(TWBv2.0).
15747855|NCT04877483|Diagnostic Test|Cytokine markers|Group GB20, Group GB20 plus BL2 and Healthy control will take the cytokine markers(IL-17、MMP-9、BAFF、BCMA) analysis.
15747856|NCT04877483|Diagnostic Test|Blood biochemical analysis|Group GB20 and Group GB20 plus BL2 will take the Blood biochemical analysis(BUN,Cre,AST,ALT,ESR and CRP).
15747857|NCT04877483|Diagnostic Test|complete blood count (CBC)|Group GB20 and Group GB20 plus BL2 will take the CBC(WBC、RBC、Hb、Platelet) analysis.
15747858|NCT04877483|Diagnostic Test|SF-36(36-Item Short Form Survey )|Group GB20 and Group GB20 plus BL2 will take the SF-36 test.
15747859|NCT04877470|Other|Consultation at spine-centre|All patients who visited the spine-centre for the first time in 2019 are included in this group.
15747860|NCT04877457|Drug|Ocrelizumab|The first course of ocrelizumab will be administered as two 300 mg infusions at Week 0 (Day 1) and Week 2 (Day 15), with the subsequent second- and third-courses given as a single 600 mg infusion at Weeks 24 and 48.
15747861|NCT04877457|Other|Placebo|Placebo will be administered at Week 0 (Day 1) and Week 2 (Day 15), with the subsequent second- and third-courses given at Weeks 24 and 48.
15747862|NCT04877444|Device|Duck Duck Punch|"Duck Duck Punch (DDP) is an interactive computer game deliberately designed to enhance UE movement quality via individualized progressive movement practice. DDP is unique as it uses Microsoft Kinect skeletal tracking technology to assess movement performance. The participant sits in front of the Microsoft Kinect and controls a virtual arm with his/her physical arm; reaching forward to punch virtual ducks. The goal 'dose' of DDP will be 200 repetitions."
15747863|NCT04877444|Behavioral|Aerobic exercise|Subjects will perform 15 minutes of aerobic exercise on a recumbent stationary cycle. The target intensity of aerobic exercise is 70% heart rate reserve. Following aerobic exercise subject will play an upper extremity rehabilitation game called Duck Duck Punch.
15747864|NCT04877444|Behavioral|Lower extremity stretching|Subjects will perform 15 minutes of lower extremity stretching. Following aerobic exercise subject will play an upper extremity rehabilitation game called Duck Duck Punch.
15747865|NCT04877418|Procedure|TeleCIMT|Mode applied remotely, through the principles and components of the CIMT protocol.
15747866|NCT04877405|Other|No intervention|This observational study is not focused on therapeutic intervention
15747867|NCT04877392|Dietary Supplement|Lavender essential oil|Use of inhaled lavender essential oil
15747868|NCT04877379|Drug|VNRX-7145|β-lactamase inhibitor
15747869|NCT04877379|Drug|VNRX-5024 (ceftibuten)|β-lactam antibiotic
15747870|NCT04877379|Drug|Placebo|Placebo
15747871|NCT04877366|Dietary Supplement|Dietary Supplement: Sprinkled Format REDUCOSE.|2 G powder sprinkle containing 250 mg REDUCOSE (mulberry leaf extract - 250 mg - 5% DNJ) + fiber, vitamin D, and chromium picolinate
15747872|NCT04877366|Other|Reference control|A placebo matching to the test product will be used as control
15747873|NCT04877366|Other|Active comparator|Acarbose 100 mg tablet (provided in open-label format)
15747874|NCT04877353|Device|NIV|NIV applied for approximately 30 to 45 min at 2- to 4-h intervals for 48 h following surgery
15747875|NCT04877340|Device|needle punction|EUS-guided sampling of pancreatic solid lesions obtained with the 22-gauge
15747877|NCT04877314|Other|Intermittent fasting|30 overweight male volunteers who will have 3 weeks intermittent fasting which has 16 hours fasting and 8 hours eating in a day period.
15747878|NCT04877301|Device|Ultrasound guidance|Ultrasound guidance used to facilitate insertion of PIV catheter
15747879|NCT04877301|Procedure|Non-ultrasound guidance|Ultrasound guidance will not be used for insertion of PIV catheter
15747880|NCT04877288|Biological|Belatacept|Specified dose on specified days
15747881|NCT04877288|Drug|Tacrolimus|Specified dose on specified days
15747882|NCT04877288|Drug|Cyclosporine A|Specified dose on specified days
15747883|NCT04877288|Drug|Mycophenolate Mofetil|Specified dose on specified days
15747884|NCT04877288|Drug|Enteric Coated Mycophenolate Sodium|Specified dose on specified days
15747886|NCT04877275|Drug|Selinexor (80mg/d)|"Selinexor (ATG-010） is a first-in-class, oral selective exportin 1 (XPO1) inhibitor (1,2). Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus along with inhibition of translation of oncoprotein mRNAs.
~Arm I：80mg/d QW ;"
15747887|NCT04877275|Drug|Selinexor (100mg/d)|"Selinexor (ATG-010） is a first-in-class, oral selective exportin 1 (XPO1) inhibitor (1,2). Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus along with inhibition of translation of oncoprotein mRNAs.
~Arm II：100mg/d QW ;"
15747888|NCT04877275|Drug|Pegylated liposomal doxorubicin|25 mg/m^2 intravenously on day 1 , QW
15747889|NCT04877275|Drug|Dexamethasone|Dexamethasone 40mg/d QW
15747890|NCT04877275|Drug|Cyclophosphamide|Cyclophosphamide：300mg/m2, d1 QW，
15747891|NCT04877262|Other|Weight maintenance diet (WMD)|A diet providing 100% of the calories to maintain participant weight
15747892|NCT04877249|Behavioral|Split-belt treadmill training|1. Split-belt gait training without or with any resistance, 2. Facilitating the knee extension during the terminal swing phase of gait cycle to identify the impact on the propulsive force generation of paretic leg
15747893|NCT04877236|Device|Green Sun Medical Brace|"All patients in the study will receive the Green Sun Medical Whisper Brace. Each GSM brace will be custom-fabricated via computer-assisted design using the 3D torso scans and a treatment plan (e.g. placement of corrective forces) devised by the treating orthotist as inputs. The brace components are then assembled. Once fabricated, the GSM brace will be fit to the subject by representatives of the manufacturer and in consultation with the treating orthotist.
~The GSM brace will be prescribed for the same number of hours per day as was the TLSO (generally 18-22 hours per day, individualized based on patient characteristics). Subjects and the family will be shown how to don and doff the brace, how to clean the brace cover, how to remove the temperature monitor, and how to remove the iButton and how to replace batteries in the GSM sensor board."
15747894|NCT04877223|Other|No intervention|No intervention
15747895|NCT04877210|Drug|Topical Insulin|Insulin (Actrapid) diluted in Normal Saline is given to participant 1 drop to both eyes 4 times per days for 4 weeks
15747896|NCT04877197|Behavioral|BA-HT|Behavioral Activation for depression delivered via home-based telehealth (BA-HT) will be implemented over 12, weekly 50-minute sessions via VA approved telehealth software.
15747897|NCT04877197|Other|Standard Care|Best practices standard care delivery for post-CVD hospitalization as regularly implemented at the RHJ VAMC. Standard care may include all or some of the following: post-operative follow up, referral to VA primary care clinic at 1 month post-procedure, primary care visit with VA mandated assessments of pain and depression with referral for these conditions, referral to facility-based or home-based cardiac rehabilitation program as appropriate. All participants in this condition will be referred to mental health care. In addition, these participants will receive a weekly telephone call from project staff during which time supportive questioning about patient progress and general mood and recovery.
15747898|NCT04877184|Device|Transcranial ultrasound stimulation and rehabilitation|"The participants in experimental group would received transcranial ultrasound stimulation and rehabilitation therapy.
~transcranial ultrasound stimulation: during 4 weeks
~rehabilitation: physiotherapy and occupational therapy (may combine with speech therapy and psychological therapy if needed)"
15747899|NCT04877184|Device|Rehabilitation|"The participants in control group would received rehabilitation therapy.
~- rehabilitation: physiotherapy and occupational therapy (may combine with speech therapy and psychological therapy if needed)"
15747900|NCT04877171|Other|telemedicine neurology consultation|consultations via phone-only at 12-14-day post-discharge. Consultations via phone both audio and video at 1, 3 and 6 months
15747901|NCT04877171|Other|in-person neurology consultation|consultation in-person at Hospital Internacional de Colombia
15747902|NCT04877158|Behavioral|Self-Blame and Perspective-Taking Intervention|The intervention is a group therapy that consists of experiential art tasks followed by psychoeducation about social behaviors with weekly homework. There are four sessions, each one week apart.
15747903|NCT04877145|Other|drill|single 3.25 mm stainless steel drill
15747904|NCT04877132|Drug|olipudase alfa (GZ402665)|Patients will receive intravenous (IV) infusion of olipudase alfa
15747905|NCT04877106|Drug|Sitagliptin Phosphate/metformin Hydrochloride Tablets(JANUMET®,50mg/850mg)|The subjects randomly received single oral administration of Sitagliptin Phosphate/metformin Hydrochloride Tablets (JANUMET®, 50mg/850mg)
15747906|NCT04877106|Drug|Sitagliptin Phosphate/metformin Hydrochloride Tablets (50mg/850mg)|The subjects randomly received single oral administration of Sitagliptin Phosphate/metformin Hydrochloride Tablets (50mg/850mg)
15747909|NCT04877080|Biological|Fast Dual CAR-T Injection|Fast Dual CAR-T injection is a autologous dual CAR-T targeted CD19 and BCMA. A single infusion of CART cells will be administered intravenously.
15747910|NCT04877067|Biological|Wharton jelly derived mesenchymal stem cell|WJ-MSC
15747911|NCT04877067|Device|Repetitive electromagnetic stimulation|rEMS
15747914|NCT04877041|Behavioral|Intradialytic Cycling|This intervention will consist of intradialytic cycling for 60 minutes 3 times per week for a total of 12 weeks.
15747917|NCT04877002|Diagnostic Test|Sona Saliva C-19 Rapid Test|Rapid Antigen diagnostic device performance comparative to RT-PCR
15747918|NCT04876989|Procedure|US-SGB|Well trained pain physician performs all the ultrasound(US)-guided stellate ganglion block(SGB)s, who is not involved in evaluating study variables. Electrocardiography, noninvasive blood pressure, heart rate, and peripheral oxygen saturation were monitored for all patients before, while, and after conducting procedure. For US-guided SGB, patients are supine positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under ultrasound guidance at C6 level. 5 ml of 1% mepivacaine is injected for the US-SGB group.
15747919|NCT04876989|Procedure|US-TPVB|Well trained pain physician performs all the ultrasound(US)-guided thoracic paravertebral block(SGB)s, who is not involved in evaluating study variables. Electrocardiography, noninvasive blood pressure, heart rate, and peripheral oxygen saturation were monitored for all patients before, while, and after conducting procedure. For US-guided TPVB, patients are prone positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under ultrasound guidance at T2 paravertebral space. 10 ml of 1% mepivacaine is injected for the US-TPVB group.
15747920|NCT04876976|Drug|Cyanoacrylate, Isobutyl|using cyanoacrylate in the surgical repair of urethro-cutaneous fistula
15747921|NCT04876976|Procedure|Classic surgical repair|classical repair of urethro-cutaneous fistula without the use of cyanoacryalte
15747922|NCT04876963|Device|Holter-monitor|7-day holtermonitoring of each patient
15747923|NCT04876950|Combination Product|Virtual care with remote automated monitoring|Use of Cloud Diagnostics connected health kit for at home monitoring with virtual clinical from nursing and perioperative physician team.
15747924|NCT04876937|Drug|Dexmedetomidine|Dexmedetomidine is infused at a rate of 0.1-0.2 μg/kg/h (0.025-0.05 ml/kg/h) from study recruitment in the ICU during mechanical ventilation, for no more than 7 days.
15747925|NCT04876937|Drug|Placebo (normal saline)|Placebo (normal saline) is infused at a rate of 0.025-0.05 ml/kg/h from study recruitment in the ICU during mechanical ventilation, for no more than 7 days.
15747926|NCT04876924|Drug|BBP-711|BBP-711, oral suspension
15747927|NCT04876924|Drug|Placebo|Placebo matching BBP-711
15747928|NCT04876911|Behavioral|Simulated Presence Therapy|A video recording of a loved one is played (via an iPad) prior to or during periods where a participant is presenting with stressed/distressed behaviours.
15747929|NCT04876898|Other|prospective cohort in high body mass index patient with covid 19|A cohort study included 114 adult patients with confirmed COVID-19 were categorized by BMI levels
15747930|NCT04876885|Other|Educational video|Three two-minute educational videos about COVID-19 vaccine development and dissemination
15747931|NCT04876872|Other|no intervention|no intervention
15747932|NCT04876859|Procedure|CRF of anterior sensitive branches to the hip|Steroid and anesthetic extra articular injection followed by denervation using CRF at 90 celsius degree during a period 90 minutes at the sensitive branches of obturator and femoral nerve, separately.
15747933|NCT04876859|Procedure|Anesthetic block with steroid injection of anterior sensitive branches to the hip|Corticosteroid and anesthetic extra articular injection at the sensitive branches of obturator and femoral nerve, only
15747934|NCT04876846|Device|GEN 3 Monitoring of Fetus|"Measurement of tissue light scatter in the body in body during late term pregnancy and evaluation of signal integrity"
15747935|NCT04876820|Other|Pharmacist intervention|"In the intervention arm, the patient meets with the pharmacist. Pharmaceutical intervention (H1) about anti-epileptic drugs prescribed will be done: information on when to take the medication, what to do if you forget to take it or vomit, and an explanation of adverse events. The aim is to improve medication adherence and patient knowledge. A report will be sent to the community pharmacist.
~An assessment of medication adherence to antiepileptic drug by MPR at H1 3 months and 6 months (phone call to community pharmacist) will be done. The health insurance score will also be done.
~An assessment of patient knowledge by a self-made knowledge questionnaire (10 items) at H1 in pre- post interview -, 3 and 6 months (phone call to patient) will be done.
~An assessment of pharmacists' satisfaction about community hospital network by a satisfaction questionnaire will be done."
15747936|NCT04876820|Other|Standard of care|An assessment of medication adherence to antiepileptic drug by MPR at the inclusion then 3 months and 6 months later will be done by a phone call to the community pharmacist. An assessment of patient knowledge by a self-made knowledge questionnaire (10 items) at the inclusion then 3 and 6 months later will be done by a phone call to the patient. The health insurance score will be also done during this call.
15747937|NCT04876807|Drug|ACP-196|In Parts 1, 2, and 3, participants will receive oral Dose 1 of ACP-196 (reference or acidic formulation as applicable) on Day 1, Day 3, Day 8, and Day 10.
15747938|NCT04876807|Drug|Omeprazole|Participants will receive omeprazole in all parts as: on Day 8 and Day 10 with water in Part 1; on Day 8 with water and on Day 10 with acidic beverage in Part 2; on Day 8 with water and on Day 10 with grapefruit juice in Part 3.
15747939|NCT04876794|Device|ABLE Exoskeleton|Participants with SCI will undergo a training programme with the ABLE Exoskeleton device three times a week for four to six weeks for a total of 12 sessions.
15747940|NCT04876781|Drug|Tofacitinib XR|Tofacitinib XR 11mg
15747968|NCT04876495|Dietary Supplement|Whey protein isolate|"Instantized BiPRO® 50g (equiv. 45.5g of total protein) presented to participants in a form of a shake.
~Other ingredients in the whey protein shake:
~Tropicana Trop50 Orange Juice 207mL
~Water 43 mL
~Sucralose 0.5g
~The total energy 233.47Kcal.
~Participants instructed to consume the entire protein shake presented to them in 5 minutes on an empty stomach when attending the study."
15748155|NCT04875052|Device|Experimental: Local Muscle Vibration|Local muscle vibration will be delivered using a prototype device at a frequency of 30Hz and acceleration of 2g for 1 minute a total of 6 times with 2 minutes of rest between exposures.
15747941|NCT04876768|Procedure|Use of different concentrations of oxygen during ERCP|The endoscopic intervention will be conducted in the endoscopy suite located at UK Albert B. Chandler Hospital in Lexington, Kentucky. ERCP/EUS uses an endoscope which is a long flexible narrow tube with a camera at the end is passed through the mouth, esophagus, stomach and the first part of the duodenum. The goal is to access a small elevation in the duodenum called the papilla of Vater. This papilla drains the biliary and pancreatic ducts which brings digestive juices from the liver, gallbladder and the pancreas. The endoscopist will inject contrast dye through the papilla into the ducts and takes X-rays to show lesions such as stones, strictures or blockages. If appropriate these can be treated by passing instruments through a port in the endoscope. Immediately following the endoscopic intervention; complications (bleeding, aspiration, perforation) will be recorded by study personnel as either yes or no, which will be used to assess the overall success of the procedure.
15747942|NCT04876755|Drug|MBM-02|MBM-02 is an HIF-1 and HIF-2 inhibitor.
15747943|NCT04876742|Other|Beer|As interventive agent beer of the brand Appenzeller Bier produced by the brewery Locher AG© in Appenzell, Switzerland is used. For the intervention group alcohol-containing and for the control group non-alcoholic wheat beer is administered once a day at 8pm during 6 consecutive days after enrolment.
15747944|NCT04876729|Behavioral|Otago Exercise Program|Otago Exercise program implemented including education on fall risk reduction, instruction on strength and balance exercises and walking program. Perform a home safety assessment and provide recommendations to reduce trip hazards. CHRs will engage local housing authority services to complete the modifications (such as grab bar installation). CHRs will complete approximately 10 home visits during 12 months with reassessment at 3, 6, and 12 months.
15747945|NCT04876716|Drug|Azole|Dosing according to the SPC
15747946|NCT04876716|Drug|Anidulafungin|200mg loading dose on day 1 and 100mg QD thereafter
15747947|NCT04876703|Device|Multichannel Functional electrical stimulation|The Xcite system is a battery-powered stimulator with up to 12 channels of cyclical stimulation. It is a task-specific modality to enhance mass practice during neurological re-education.
15747948|NCT04876703|Other|Standard motor training|Standard motor training is the conventional rehabilitation treatment
15747949|NCT04876677|Drug|Beclomethasone dipropionate/Formoterol Fumarate/Glycopyrronium|Two inhalations bid: 4 inhalations; total daily dose of 400/24/50 μg BDP/FF/GB
15747950|NCT04876664|Device|measuring blood pressure with noninvasive blood pressure device|To measure blood pressure in different circumstances with noninvasive blood pressure device
15747951|NCT04876651|Other|177Lu-DOTA-rosopatamb|Two single intravenous (IV) injections of 76 mCi each (equivalent to a 45 mCi/m2 dose in a standard 1.7m2 individual) of 177Lu-DOTA- rosopatamab, given 14 days apart, plus best SoC
15747952|NCT04876638|Drug|Minocyclin|10mg/kg minocycline up to 700mg for 4 days following aneurysmal subarachnoid hemorrhage
15747953|NCT04876625|Device|myTAP oral appliance plus mouth shield|myTAP anti-snoring oral appliance worn with mouth shield for all 8-weeks
15747954|NCT04876625|Device|myTAP oral appliance alone for first 4 weeks|myTAP anti-snoring oral appliance worn alone for first 4 weeks followed by wearing it for 4 weeks with the mouth shield
15747955|NCT04876612|Procedure|Transforaminal epidural steroid injection (TFESI)|Well trained pain physician performs all the fluoroscopy-guided transforaminal epidural steroid injection (TFESI), who is not involved in evaluating study variables. Electrocardiography, noninvasive blood pressure, heart rate, and peripheral oxygen saturation were monitored for all patients before, while, and after conducting procedure. For TFESI, patients are prone positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under fluoroscopy guidance at the patient's symptom complaining level. After confirming with a contrast medium, 3 ml of 0.1875% ropivacaine and 5 mg of dexamethasone are administered.
15747956|NCT04876599|Behavioral|IN FOCUS|Adapted Resiliency Group Intervention
15747957|NCT04876599|Behavioral|Usual Care|Referral to Virtual Group Support
15747958|NCT04876586|Procedure|Lumbar fusion|Transforaminal Lumbar Interbody Fusion of the SPECT/CT positive degenerative disc disease
15747959|NCT04876573|Drug|Cyproheptadine Hydrochloride 4 MG|"Phase 1: Cyproheptadine 4 mg three time a day for 10 days, per oral administration associated to Standard care of COVID 19 patient currently recommend by WHO
~Phase 2: Cyproheptadine 8 mg three time a day for 10 days, per oral administration associated to Standard care of COVID 19 patient currently recommend by WHO
~The dose will be adjusted according to the renal function."
15747960|NCT04876560|Other|Application of CDSS to provide nutritional care in breast cancer patients from home|A personalised dietary plan was implemented by the CDSS. The CDSS estimated body mass index (BMI) and Total daily Energy Expenditure (TEE) according to individual's incorporated data. For overweight and obese patients, the CDSS produced a hypocaloric diet, in which daily energy intake was less than TEE by approximately -500 kcal/day. Nutrient distribution was in line with the Mediterranean dietary pattern. Patients received individual login passwords to CDSS allowing access to their personal profile from home. During the trial, patients were instructed to record food diaries in the CDSS every week, which were also made available to the dieticians. Visiting the CDSS, patients had the opportunity to track their progress e.g. monitoring goals of body weight, physical activity, consumption of fruits, vegetables, legumes.
15747961|NCT04876560|Other|General lifestyle advice to breast cancer patients by phone|General lifestyle guidelines were provided by phone and food diaries were sent via emails.
15747962|NCT04876547|Procedure|appendectomy|appendectomy performance
15747963|NCT04876534|Drug|Tocilizumab 20 Mg/mL Intravenous Solution|Intravenous administration
15747964|NCT04876534|Drug|MethylPREDNISolone Injectable Solution|Intravenous administration
15747965|NCT04876521|Drug|Amisulpride|low dose of Amisulpride at 100-300 mg/day
15747966|NCT04876521|Drug|Olanzapine-Fluoxetine Combination|Olanzapine (5 mg/day) and Fluoxetine (10-20 mg/day)
15747967|NCT04876508|Other|Accupressure|Patients in the experimental group will be given acupressure once a day for 7 consecutive days. Acupressure application will be applied by researchers who have been trained and certified on this subject. While the patients are in supine position, pressure will be applied to each acupressure point around the navel, respectively, Zhongwan (CV12), Guanyuan (CV4) and Tianshu (ST25) for 2 minutes for a total of 6 minutes.
15782465|NCT04593329|Other|DIPYRONE PLACEBO|Dipyrone placebo tablet
15747969|NCT04876495|Dietary Supplement|Potato protein isolate|"Solanic®100 48g (equiv. 45.3g of total protein) presented to participants in a form of a shake.
~Other ingredients in the potato protein shake:
~Tropicana Trop50 Orange Juice 250mL
~Sucralose 0.5g
~The total energy 233.46Kcal
~Participants instructed to consume the entire protein shake presented to them in 5 minutes on an empty stomach when attending the study."
15747970|NCT04876495|Dietary Supplement|Rice protein isolate|"Oryzatein® Silk 90 50g (equiv. 45.5g of total protein) presented to participants in a form of a shake.
~Other ingredients in the rice protein shake:
~Tropicana Trop50 Orange Juice 183mL
~Water 67mL
~Sucralose 0.5g
~The total energy 233.43Kcal
~Participants instructed to consume the entire protein shake presented to them in 5 minutes on an empty stomach when attending the study."
15747971|NCT04876482|Procedure|transoral robotic surgery|transoral robotic surgery (TORS) which remove the extra soft tissue of the base of the tongue and soft palate in this study
15747972|NCT04876482|Device|oral appliance|It is a kind of treatment for the participants who refuse surgeries and choose to use other kinds of conservative treatment. The conservative treatments included oral appliance, losing weights and using continuous positive airway pressure. The oral appliance would be wore only at night and it would press the soft palate and protrude the jaw.
15747973|NCT04876482|Device|using continuous positive airway pressure|The participants only used CPAP at night. The device composed of a main machine, pipe and mask. The participants would instruct to wore the mask. The main machine would give positive airway pressure to open the airway and avoid collapsing.
15747974|NCT04876482|Behavioral|losing weights|The participants would ask to lose weight by changing their diets and exercising, without using drugs and surgeries.
15747975|NCT04876482|Combination Product|oropharyngeal rehabilitation|OPR included exercise for soft palate, tongue and oropharynx. There are 13 movements in OPR. The movements would be teach by a physical therapist.
15747976|NCT04876469|Procedure|Pulsed Radiofrequency treatment of the lumbar dorsal root ganglion|Using radiocontrast media or not for the pulsed radiofrequency treatment of the lumbar dorsal root ganglion
15747977|NCT04876456|Drug|Cabozantinib|Patients will be treated with Cabozantinib 60mg orally daily continuously until disease progression, unacceptable toxicity, or trial closure.
15747978|NCT04876443|Diagnostic Test|Study questionnaire|Study questionnaire related to drinking behaviour
15747979|NCT04876430|Drug|Meropenem|Meropenem 2g every 8h for patients with glomerular filtration rate (GFR) equal or higher that 50 mL/min. Dose adjustment is recommended for patients with GFR < 50mL/min.
15747980|NCT04876417|Device|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability.
15747981|NCT04876417|Device|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability.
15747982|NCT04876404|Diagnostic Test|PET/MR Imaging|The hybrid PET/MR scanner can provide information on brain activity during various motor and cognitive tasks.
15747984|NCT04876378|Procedure|Magnetic Resonance Imaging|Undergo MRI
15747985|NCT04876378|Other|Questionnaire Administration|Complete questionnaires
15747987|NCT04876352|Other|Upper limb/handwriting exercises in an immersive virtual reality setting (VR-training)|"Progressively difficult multimodal physiotherapy under the augmented visual feedback induced by the VR. Participants will wear a head-mounted display and their upper limb movements during the training will be captured by a motion tracker. Patients will perform: repetition of movements of upper limb single joints (shoulder, elbow and wrist) under the augmented visual feedback provided by the use of VR in increasingly wide range of movement; active upper limb multi-joints movements under the augmented visual feedback provided by the use of VR (following trajectories designed in the virtual space - movement involving shoulder, elbow and wrist joints) and handwriting tasks and touch screen technology usage in VR context on a tablet and a smartphone.
~30 minutes of exercises, 2 times a week, for 8 weeks."
15747988|NCT04876352|Other|Upper limb/handwriting exercises in a real setting (RS-training)|"Participants will perform progressively difficult multimodal physiotherapy in a real setting. Participants will be encouraged to perform their upper limb movements during the training in order to perform faster and ampler movements. They will perform: repetition of movements of upper limb single joints (shoulder, elbow and wrist) in increasingly wide range of movement under the feedback provided by therapist; active upper limb multi-joints movements under the feedback provided by the therapist (following trajectories designed on a table or on a blackboard - movements involving shoulder, elbow and wrist joints) and handwriting tasks and touch screen technology usage under the supervision of the therapist.
~30 minutes of exercises, 2 times a week, for 8 weeks."
15747989|NCT04876352|Other|No intervention|Only baseline evaluations, without longitudinal assessment
15747990|NCT04876339|Device|"Gait rehabilitation with sonification"|The sonification system is composed by 2 inertial sensors, a computer and a pair of bluetooth headphones connected with the computer. The sensors will be placed one per leg at the ankle and connected with Matlab software. An home-made ad-hoc software associates patient's movements with music patterns. The patient's natural rhythm is detected and used at the beginning of the intervention. The first part of each exercise is supported by a pre-recorded chord progression with a click on the background. In the second part (sonification approach) the software notices and records the contact of the heel with the ground. Each contact activates musical stimuli listened to via headphones. The steps succession will build a regular and predictable musical progression in relation to the correct sequence of steps. The exercises planned in this intervention are the same as those planned in the gait standard rehabilitation (see below).
15748039|NCT04875962|Drug|UCB0599|Participants will receive an assigned dosage regimen of UCB0599 during the Treatment Period.
15748040|NCT04875962|Drug|Placebo|Participants will receive an assigned dosage regimen of Placebo during the Treatment Period to maintain the blinding.
15748041|NCT04875949|Procedure|Immunoabsorption/plasmapheresis procedure|
15747991|NCT04876339|Other|Standard gait rehabilitation (without sonification)|"The training will be carried out without any musical support. Exercises I Phase
~Load shift in anteroposterior standing in tandem position, left foot forward (3 minutes exercise with a short break in the middle)
~Load shift in anteroposterior standing in tandem position, right foot forward (3 minutes exercise with a short break in the middle)
~Left foot swing (3 minutes exercise with a short break in the middle)
~Right foot swing (3 minutes exercise with a short break in the middle)
~March in place (3 minutes exercise with a short break in the middle) Exercises II phase (15 minutes): the patient will perform 14 minutes of walking with a 1 minute of break in the middle (7 minutes of walking, 1 minute rest, 7 minutes of walking). In the second part of walking the patient will be asked to slightly increase the pace of the step up to the maximum possible speed."
15747992|NCT04876326|Biological|Autologous Adipose Mesenchymal Stem Cell Implantation|"Before taking adipose tissue, each subject was screened including HbSAg, Anti HbS, Anti HCV, HIC, MCV and syphilis tests.
~Adipose tissue was taken through 5 grams of subcutaneous fat biopsy from the abdomen of each subject and put into a transport medium and then sent to the RSCM-FKUI cGMP IPT Stem Cells Laboratory for immediate isolation of mesenchymal stem cells.
~MSC that has been isolated will be cultured using the appropriate medium until it reaches the desired passage and the number of cells.
~The viability and proliferation ability of cultured cells were evaluated, then characterization of cell antigen expression was carried out using flow cytometry to confirm the success of MSC culture.
~The MSC to be injected into the subject will be prepared in 2cc physiological NaCl transport medium just before implantation.
~The adipose secretion used is prepared in whole form as much as 10cc in a 10cc syringe."
15747993|NCT04876326|Biological|Allogeneic Umbilical Cord Mesenchymal Stem Cell Implantation|"Before taking the umbilical cord tissue, a pregnant woman's donor was screened including HbSAg, Anti HbS, Anti HCV, HIC, MCV and syphilis tests.
~Immediately after delivery, the umbilical cord was collected and stored in a sterile specimen plate containing 0.9% NaCl at 4⁰C.
~The umbilical cord is transported to the GMP standard culture laboratory at the UPT TK Stem Cells RSCM-FKUI for isolation process of mesenchymal stem cells. Sample processing was carried out within 8 hours of delivery to maintain cell viability.
~MSC that has been isolated will be cultured using the appropriate medium until it reaches the desired passage and the number of cells.
~The viability and proliferation ability of cultured cells were evaluated, then characterization of cell antigen expression was carried out using flow cytometry to confirm the success of MSC culture.
~The MSC to be injected into the subject will be prepared in a suitable transport medium just prior to implantation."
15747994|NCT04876326|Biological|Allogeneic Umbilical Cord Mesenchymal Stem Cell and Adipose Secretome Implantation|"Before taking adipose and umbilical cord tissue, each subject was screened. -For Adipose tissue : The adipose secretion used is prepared in whole form as much as 10cc in a 10cc syringe.
~-Uc-MSC : Immediately after delivery, the umbilical cord was collected and stored in a sterile specimen plate containing 0.9% NaCl at 4⁰C.
~The umbilical cord is transported to the GMP standard culture laboratory to have isolation process of mesenchymal stem cells. Sample processing was carried out within 8 hours of delivery to maintain cell viability.
~Later it will be cultured using the appropriate medium until it reaches the desired passage and the number of cells.The viability and proliferation ability of cultured cells were evaluated, then characterization of cell antigen expression was carried out using flow cytometry to confirm the success of MSC culture."
15747995|NCT04876313|Drug|Nivolumab + Nab-paclitaxel|4x3 weekly cycles of 360 mg nivolumab + 125 mg/m^2 nab-paclitaxel IV on days 1 and 8
15747996|NCT04876313|Drug|Nivolumab|360 mg IV Q3W x 13 cycles
15747997|NCT04876300|Other|No intervention|All directions for medication usage were solely at the discretion of the investigator in accordance with their usual routine clinical practice and are assumed to be consistent with the national prescribing information of the medicinal product in the country in which the study will take place.
15747998|NCT04876287|Drug|Radioiodine|cancer therapy
15747999|NCT04876274|Behavioral|TMU-LOVE|Patients in intervention group could attend diabetes-related health educational video through the TMU-LOVE platform. Researcher would also send 2-3 videos per week with care massage every 2 weeks to the patients.
15748000|NCT04876261|Dietary Supplement|Oliphenolia® bitter|"ingredients: concentrated watery extract of olives 94%, lemon juice 6%
~35 mg hydroxytyrosol, 0,24 mg Oleuropein"
15748001|NCT04876261|Dietary Supplement|Oliphenolia®|"ingredients: grape juice concentrate 70%, concentrated watery extract of olives 30%
~38 mg hydroxytyrosol, 0,28 mg Oleuropein"
15748002|NCT04876261|Dietary Supplement|La Vialla Extra Virgin Olive Oil containing 5 mg hydroxytyrosol|"extra virgin olive oil
~5 mg hydroxytyrosol"
15748005|NCT04876235|Procedure|endoscopic ultrasound|All patients were implanted with stents（DPPS or LAMS）under the EUS
15748006|NCT04876235|Device|lumen-apposing metal stent|In the LAMS group, patients were stented with LAMS
15748007|NCT04876235|Device|double-pigtail plastic stents|In the DPPS group, patients were stented with DPPS
15748008|NCT04876222|Procedure|Acute CAG|The patient is triaged directly to the catheterization laboratory for acute evaluation including ECHO, acute CAG and PCI if indicated according to guidelines.
15748009|NCT04876196|Other|Selfapy for Bulimia Nervosa|Web-based intervention for Bulimia Nervosa with six mandatory weekly sessions covering topics related to eating behaviors, emotion regulation, and stress management, followed by an optional set of up to six modular specialization areas based on individual therapy goals. During the intervention, participants can access an online chat providing crisis management, answering questions concerning the exercises, and technical support. The chat does not include the opportunity to discuss individual topics and concerns about treatment.
15748010|NCT04876183|Other|Selfapy for Binge Eating Disorder|Web-based intervention for Binge Eating Disorder with six mandatory weekly sessions covering topics related to eating behaviors, emotion regulation, and stress management, followed by an optional set of up to six modular specialization areas based on individual therapy goals. During the intervention, participants can access an online chat providing crisis management, answering questions concerning the exercises, and technical support. The chat does not include the opportunity to discuss individual topics and concerns about treatment.
15748087|NCT04875572|Device|Analgesia Nociception Index (ANI) Monitor|The ANI monitor produces an objective measure of parasympathetic tone through non-invasive electrodes placed on the patient's chest. The patient's standard of care is not affected, and the anesthetist is blinded to the monitor, so as not to affect their anesthetic practice.
15748011|NCT04876170|Other|Brain-computer-interface: EEG-based musical Neurofeedback task|Neurofeedback training with EEG, in which participants are presented with self-selected music and requested to make the presented music sound better by applying mental strategies. Six repeated training sessions, each composed of five training cycles. Each cycle is composed of 120 sec of 'local baseline' block and 90 sec of 'regulation' block while listening to self-selected music. Participants are instructed to passively listen to their self-selected music during the 'local baseline' block, and to 'make the music sound better' during the 'regulation' block. Participants are instructed to recruit chosen mental strategies, which they find to be most efficient towards this regulatory task. During 'regulation', the quality of the sound varies in real-time (every 3 sec) in proportion to the difference between the current value of VS-EFP and its average value during 'local baseline'.
15748012|NCT04876157|Diagnostic Test|Artificial intelligence-aimed point-of-care ultrasound image interpretation system|improve the sensitivity and specificity of the AI-aimed ultrasound interpretation system
15748013|NCT04876144|Device|Kogito|"Users of the Kogito app progress throught the deep self-help intervention in a sequence of 5 modules. The base of the Kogito app is in the cognitive-behavioral therapy (CBT), relaxation techniques and peer support.
~Module
~Introduction to the CBT (psychoeducation) and deep breathing relaxation plus perinatal peer support videos. Emotional tracking.
~Behavioral activization, relaxation techniques, CBT diary, psychoeducation on anxiety and depression, peer support.
~CBT - vicious circle, progressive muscle relaxation, peer support content
~Cognitive distortions, relaxation in imagination, peer support content
~Cognitive restructuring, mindfulness relaxation, peer support content.
~Progress in the Kogito app is conditional on the completion of various CBT tasks"
15748014|NCT04876131|Drug|Benzylpenicillin - single dose|"Participants will receive a single dose of IV antibiotic (benzylpenicillin).
~Benzylpenicillin dosing: 1 month - 18 years, IV or Intramuscular (IM) 30 mg/kg (maximum 1.2 g) every 6 hours."
15748015|NCT04876131|Drug|Benzylpenicillin - three days|"Participants will receive three days of this IV antibiotic (benzylpenicillin).
~Benzylpenicillin dosing: 1 month - 18 years, IV or Intramuscular (IM) 30 mg/kg (maximum 1.2 g) every 6 hours. For severe infections, use up to 60 mg/kg (maximum 2.4 g) every 4-6 hours."
15748016|NCT04876131|Drug|Gentamicin - single dose|"Participants will receive a single dose of IV antibiotic (gentamicin).
~Gentamicin dosing: Children ≤10 years old: 7.5 mg/kg (maximum dose 320 mg) Children >10 years old: 6-7 mg/kg (maximum dose 560 mg)"
15748017|NCT04876131|Drug|Gentamicin - three days|"Participants will receive three days of this IV antibiotic (gentamicin).
~Gentamicin dosing: Children ≤10 years old: 7.5 mg/kg (maximum dose 320 mg) Children >10 years old: 6-7 mg/kg (maximum dose 560 mg)"
15748018|NCT04876131|Drug|Cefalexin - post single dose of IV antibiotics for the remaining two days|Oral antibiotic will be as per local guidelines. i.e. Cefalexin 25mg/kg (maximum dosage 500mg) 4 times a day or 33mg/kg (maximum dosage 500mg) 3 times a day
15748019|NCT04876118|Device|The ZELTIQ System|The CoolSculpting machine will be used to perform the treatments.
15748020|NCT04876105|Other|Assesment of treatment preference|Multiple-choice survey questions were created by the researchers based on the studies in the literature regarding the pain and treatment preferences of the participants
15748021|NCT04876092|Drug|JNJ-67856633|Participants will receive JNJ-67856633 orally.
15748022|NCT04876092|Drug|Ibrutinib|Participants will receive Ibrutinib orally.
15748023|NCT04876079|Other|Test to induce a decline in plasma glucose|Participants will be admitted at the research center at 7:00 after an overnight fast. A venous catheter will be inserted into an arm vein for blood sampling purposes. A subcutaneous insulin bolus will be administered to bring plasma glucose to the glycemic threshold. Oral carbohydrates (16g) will be given when plasma glucose levels are at the target threshold. Sixty minutes after carbohydrates consumption, a standardized meal will be provided and participants will be discharged 90 minutes after the meal.
15748024|NCT04876079|Device|Dexcom G6|Participants will have to wear a Dexcom G6 during study interventions
15748025|NCT04876079|Other|Dex4|When the glycemic threshold is reach, participants will be given 16g of Dex4
15748026|NCT04876079|Drug|Insulin|A subcutaneous insulin bolus will be given to induce a decline in plasma glucose and reach the glycemic threshold.
15748027|NCT04876066|Drug|Ketamine|Weight-based ketamine dose will be prepared and delivered personally to study physician or study personnel by pharmacy personnel as is done during standard protocol for use of ketamine not part of a clinical study.
15748028|NCT04876053|Behavioral|Healthy Food Delivery Intervention|Each weekly food box will include ~9,000 calories of food, equivalent to the amount the average household receives prorated per week from an average Arkansas food pantry. The boxes will be designed by a registered dietitian. The boxes will follow ADA's Create Your Plate method consistent with the meal pattern promoted in the American College of Physicians (ACP) DSMES. The foods will also reflect Feeding America's Detailed Foods to Encourage framework, developed by nutrition experts and food bank staff to represent USDA dietary guidelines with healthy food that can be made available by food banks.
15748029|NCT04876040|Device|SSO2 Downstream System|60-min adjunctive reperfusion of hyperoxemic blood into target coronary artery, immediately following revascularization by means of PCI with stenting.
15748030|NCT04876040|Procedure|PCI + Impella|Standard of Care Intervention
15748031|NCT04876027|Drug|GLP-1 RAs|GLP-1 receptor agonist is a glucagon-like peptide 1 analog, which is related to improving blood sugar control, weight loss and appetite suppression, and reducing cardiovascular risk.
15748032|NCT04876027|Other|calorie restricted diet|Calorie restricted diet can improve insulin sensitivity, liver fat in patients with visceral obesity, and metabolism and hormone levels in obese women with PCOS.
15748033|NCT04876014|Other|Guided Mobile-Based Perinatal Mindfulness Intervention|GMBPMI includes 6 EBMI lessons in 6 weeks, and it will require the participants to do mindfulness practice for about 30-60 minutes daily. The project RA will send prompt and guidance for daily mindfulness practice to each participant through social media platform. The RA will be available online to support, and will initiate chat every week throughout the whole intervention period. The chats will focus on participants' experiences or difficulties of mindfulness practice.
15748034|NCT04876001|Behavioral|Brief Behavior Therapy for Insomnia|"The BBTI consists of two in-person sessions on week 1 and 3 and two sessions on week 2 and 4 as the booster delivered by phone call."
15748035|NCT04875988|Procedure|Butterfly iQ+ Ultrasound|ultrasound will be used in the intervention group for IV access
15748036|NCT04875988|Procedure|Traditional|ultrasound will not be used in the traditional IV placement group
15748042|NCT04875936|Behavioral|Motor Imagery and Real-Time fMRI Neurofeedback|Survivors of left-hemisphere stroke (<5 weeks post-stroke) or healthy volunteers will use right-hand motor imagery coupled with fMRI neurofeedback to help them re-engage the left hemisphere by shifting brain activation leftward relative to the initial left-right asymmetry. Following group assignment, participants will perform a motor imagery task and complete 3 sessions of motor imagery and reading tasks in the MRI scanner over 3 weeks. During the MRI sessions they will receive real time neurofeedback about how well they are engaging the left side of their brain compared to the right side. They will also practice the same task for 30 min a day as homework using the most effective motor imagery strategy that worked for them in the MRI scanner.
15748043|NCT04875936|Behavioral|Motor Imagery and Sham fMRI Neurofeedback|Survivors of left-hemisphere stroke (<5 weeks post-stroke) or healthy volunteers will practice right-hand motor imagery coupled with sham fMRI neurofeedback. As the experimental group, participants will perform a motor imagery task and complete 3 sessions of motor imagery and reading tasks in the MRI scanner over 3 weeks. However, during the MRI sessions they will receive sham neurofeedback on the basis of another participant's brain activity. Like the experimental group, they will also practice the same task for 30 min a day as homework.
15748044|NCT04875910|Other|Home-based exercise program|"The exercise program will include task specific training to improve balance and the training will progress every two weeks. A Physical therapist will be following up and monitoring the participants adherence to the training by audio or video call.
~The exercise program for Week 1: Sit to Stand 5 times, Steps forward, backward and to the sides 5 times, 10 meters walk. 45 minutes session /3 times per week. Week 2: Sit to stand 10 times, Steps forward, backward and to the sides 5 times , Sit and reach 5 min for each hand and walk for 15 meters. 45 minutes session, 3 times per week. Week3 Sit to stand 10 times, Step on bench 5 times, Stand and reach 5 and walk for 15 meters. 45 minutes session, 3 times per week. Week 4 Stand and reach 5 times, Step on bench 10 times, climbing stairs (5 steps flight stairs up and down) and walk for 20 meters. 50 minutes session, 3 times per week."
15748045|NCT04875897|Device|keepMED PAP device|The keepMED PAP device is an automatic, wearable positive airway pressure device indicated for treatment of obstructive sleep apnea. A therapeutic pressure is delivered to the patient upper airway through a nasal interface. It is similar to other marketed positive airway pressure devices with respect to its fundamental use of positive airway pressure for the treatment of sleep apnea as well as with regard to its functional components and accessories (e.g., a PAP unit, a mask/nasal interface, an air filter, tubing, etc.).
15748046|NCT04875884|Device|Modified MRI|A technical modification to the standard MRI which only affects radiofrequency pulse polarization attempting to optimize the image quality. All other factors, including pulse sequence parameters, and patient and coil positioning is similar to that of the standard MRI.
15748047|NCT04875871|Radiation|Particle radiotherapy|Partial radiotherapy targeting the hypoxic tumor segment
15748048|NCT04875871|Diagnostic Test|Magnetic resonance imaging|For treatment planning as well as for follow-up radiological tumor assessment.
15748049|NCT04875871|Diagnostic Test|Computertomography|For treatment planning as well as for follow-up radiological tumor assessment.
15748050|NCT04875871|Diagnostic Test|Copper-64-Diacetyl-bis (N4-methylthiosemicarbazone) Positron Emission Tomography-Computer Tomography (64Cu-ATSM-PET-CT)|For the definition of the hypoxic tumor segment in treatment planning.
15748051|NCT04875871|Diagnostic Test|18-F-FluorDesoxyGlukose Positron Emission Tomography-Computer Tomography (18F-FDG-PET-CT)|For follow-up radiological tumor assessment.
15748052|NCT04875871|Diagnostic Test|Blood sampling|Evaluation before treatment-start, during treatment and follow-up period.
15748053|NCT04875858|Drug|ProDiax-23 (PPSV23)|diabetic old adults aged 70-75 years who received PPSV23 in previous 5-7 years (Persons 65-70 years old who have been inoculated with PPSV23 and 5-7 years have passed) and healthy old adults aged 70-75 years who received PPSV23 in previous 5-7 years (Persons 65-70 years old who have been inoculated with PPSV23 and 5-7 years have passed)
15748054|NCT04875845|Behavioral|Fasting for elective surgery|6-hours and 8-hours fasting before elective surgery
15748055|NCT04875832|Behavioral|Eye Movement Desensitization and Reprocessing - EMDR|"EMDR is a comprehensive psychotherapy approach, originally developed to treat the victims of trauma. EMDR is guided by an information processing model known as the Adaptive Information Processing (AIP) model. One of the key assumptions of the AIP model is that dysfunctionally stored (disturbing) memories are the cause of several mental pathologies. EMDR is therefore used to address a range of complaints that follow distressing life experiences and it
~is characterized by an eight-phase psychotherapy approach. The intervention is based on the use of bilateral stimulation (e.g., taps, tones, or eye movements), which aims to stimulate the information processing system of the brain in combination with other methods of established psychotherapies. EMDR is widely recognized as an empirically supported treatment for post-traumatic stress disorder (PTSD) and it is one of the best psychological treatment focused on the ri-processing of recent traumatic experiences"
15748056|NCT04875819|Drug|Neisseria meningitidis oligosaccharide conjugate vaccine and recombinant protein-based vaccine|One dose (0.5 ml) of conjugate vaccine against meningococcal serogroups ACWY (Menveo®) and one dose of a recombinant protein-based vaccine against meningococcal serogroup B (Bexsero®) at day 0 followed by another dose (0.5 ml) of each vaccine at day 60.
15748057|NCT04875819|Drug|13 valent pneumococcal conjugate vaccine and 23 valent pneumococcal polysaccharide vaccine|One dose (0.5 ml) of pneumococcal conjugate vaccine (Prevenar13®) at day 0 and one dose (0.5 ml) of pneumococcal polysaccharide vaccine (Pneumovax23®) at day 60.
15748058|NCT04875806|Drug|NC762|NC762 is an experimental antibody drug that may make the immune response more active against cancer
15748059|NCT04875793|Diagnostic Test|Stool for Occult Blood Test and Colonoscopy with comprehensive medical checkups|participants will be drawn from all public government institutions inside Tabuk city(outreach). The institution head will be requested to give wellness cards to the eligible employee to receive comprehensive testing for free in addition to CRC test in selected public health centres.
15748088|NCT04875559|Other|Standardised multimodal pain treatment regimen|"Preoperatively:
~Paracetamol 1000 mg p.o.
~Celecoxib 400 mg p.o.
~Dexamethasone 12 mg p.o.
~Perioperatively:
~Ondansetron 4 mg IV
~Bupivacaine 2.5 mg/mL, 20 mL LIA
~Oxycodone 0.15 mg/kg IV (Oxycodone 0.25 mg/kg for ALND)
~Postoperatively:
~Paracetamol 1000 mg p.o. every 6h PRN
~Ibuprofen 400 mg p.o. every 6h (day 1-5) PRN
~Oxycodone 5 mg IV or 10 mg p.o. PRN
~Ondansetron 4 mg IV or p.o. PRN"
15748482|NCT04872530|Dietary Supplement|Red lentil protein concentrate|Red lentil protein concentrate
15748063|NCT04875767|Device|HA-based scaffold with BMA (Hyalofast®; Anika Therapeutics, Bedford, MA, USA)|General surgical and anaesthetic risks apply to the subjects included in the trial. Microfracture and BMA are surgical techniques currently being used and are approved for use in Canada. The HA-scaffold that will be used in this trial (Hyalofast®, Anika Therapeutics Inc.) has European CE Mark for use in all joints. We will obtain a Health Canada approval to use the Hyalofast® product in the hip for this trial.
15748064|NCT04875754|Genetic|ICM-203|Intra-articular injection
15748065|NCT04875754|Drug|Placebo (saline solution)|Intra-articular injection
15748066|NCT04875741|Other|Neural mobilization|Mobilization of the structures within and around the nervous system is broadly known as Neural Mobilization.
15748067|NCT04875741|Other|Muscle energy technique|Manual therapy technique initially developed and used by the osteopaths is known as Muscle energy techniques(MET).This technique is effective for the pain reduction, lengthening of the shortened muscle and fascia, improvement in blood circulation and promoting lymph drainage.
15748068|NCT04875728|Drug|Cefazolin|Given IV
15748069|NCT04875728|Procedure|Resection|Undergo standard of care surgical resection
15748070|NCT04875715|Other|Almond Oil|Almond oil
15748071|NCT04875715|Drug|Hydroquinone Topical|Hydroquinone 2% cream
15748072|NCT04875702|Drug|Allopurinol|"For the TTT-SU group: The dose titration algorithm for allopurinol increases every 4 weeks by 100 mg until the target serum urate of 6 mg/dL is reached or a patient requires 800 mg per day of allopurinol. Subjects will require a blood draw for SU every 4 weeks until reaching the target.
~For the TTASx group: Subjects randomized to the TTASx group will receive anti-inflammatory treatments (naproxen, colchicine, and/or prednisone) for up to six flares over the ensuing three months. Urate lowering therapy (ULT) will only be offered after the third flare during the trial."
15748073|NCT04875702|Drug|Antiinflammatory Agent for Gout Flare Prophylaxis|naproxen, colchicine and/or prednisone as flare prophylaxis
15748074|NCT04875689|Other|Group A (Experimental|"Laser therapy is performed on patients in supine lying position. Treatments will be delivered with a diode laser (wavelength 830 nm, continuous wave, power 50 mW) in skin contact at a dose of 6 J/point. Treatment times per point are in the range of 30 seconds to 1 minute. eight points were irradiated per session.
~Conventional therapy will include:
~TENS for 15 minutes
~Hot pack for 15 minutes
~Hamstrings muscle stretching and calf muscle stretching. Strengthening exercises ,straight leg raising exercise in crook lying position
~Joint mobilizations"
15748075|NCT04875689|Diagnostic Test|Group B (Control)|"1. Participants of this group will receive only conventional therapy which will include;
~TENS for 15 minutes
~Hot pack for 15 minutes
~Hamstrings muscle stretching and calf muscle stretching.Each stretch was sustained for 30 seconds, with 10-second rest intervals.
~Strengthening exercises include quadricep drills(full knee extension maintained for 5 seconds, followed by a 5-second rest) 20 repetitions per session,straight leg raising exercise in crook lying position(the patients were asked to tense the quadriceps muscle, elevate the limb to 45° and maintain it for 6 seconds, and lower the limb slowly and then relax for 6 seconds; the exercise was performed for three sets of 10 repetitions per session).
~Joint mobilizations (tibiofemoral extension and flexion; patellofemoral medial-lateral and inferior glide)."
15748076|NCT04875676|Biological|VXA-G1.1-NN|Norovirus GI.1 Norwalk VP1 Vaccine, Oral E1-/E3-Deleted Replication Defective Recombinant Adenovirus 5 with double-stranded RNA Adjuvant
15748077|NCT04875663|Behavioral|Lifestyle Medicine|Lifestyle intervention including diet, sleep, exercise, relaxation and mindfulness
15748078|NCT04875650|Procedure|Extraction of Mandibular Molar using Physics Forceps|Extraction of mandibular molars using physics forceps
15748079|NCT04875650|Procedure|Extraction of Mandibular Molar using Conventional Forceps|Extraction of mandibular molars using conventional forceps
15748080|NCT04875637|Diagnostic Test|WAI-MEMR|Using wideband acoustic reflectance for middle-ear muscle reflex.
15748081|NCT04875624|Diagnostic Test|Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4)|Bayley Scales of Infant and Toddler Development, Fourth Edition (Bayley-4) will be administered by one of the 2 blinded examiners who are unaware of neonatal glycemia status. Bayley-4 examines Cognitive, Language, Motor, Social-Emotional and Adaptive Behavior domains of development and may require up to 120 minutes to complete.
15748082|NCT04875611|Drug|Opdivo|Dose of Nivolumab is constant and is 240 mg .All patients will undergo maximum of 12 cycles of investigation product's infusion ( around 6 month of treatment).Each cycle will be done in intervals of 14 day (no less than 12 days after previous infusion and no longer than 42 day/6 weeks after previous infusion).
15748083|NCT04875598|Procedure|Ultrasound assisted - Laparoscopy assisted Transversus Abdominis Plane Block|Ultrasound assisted TAPB application will be applied by an anesthesiology and reanimation specialist and Laparoscopy assisted TAPB application will be applied by the surgeon performing the operation.
15748084|NCT04875585|Drug|neoadjuvant therapy with Pembrolizumab/Lenvatinib|Neoadjuvant therapy for 6 weeks
15748085|NCT04875585|Procedure|Surgery|surgical resection of primary tumor and lymph-node-dissection.
15748086|NCT04875585|Drug|Adjuvant Treatment Phase|Adjuvant treatment with 15 cycles of Pembrolizumab
15748483|NCT04872530|Dietary Supplement|Non-essential amino acid blend|Non-essential amino acid blend
15748089|NCT04875546|Behavioral|Standard treatment|Adolescent will receive a brief smoking cessation intervention based on the '5A' and '5R' models. Then the research assistant will ask about their tobacco use and assist them to quit using the STAR method. A booster intervention will be given over the phone at 1-week, 1month, 3-month, and 6 month follow-up.
15748090|NCT04875546|Behavioral|Integrated Intervention|In addition to the brief smoking cessation intervention based on the '5A' and '5R' models, the participants will receive brief advice on alcohol use based on the FRAMES model. Then the RA will invite participants to complete the Alcohol Use Disorders Identification Test and provide personalized feedback. There will be a one to one, 20-30 minutes semi-structured interviews with 30 participants. Participants with high(N=15) and low (N=15) adherence will be purposively selected. A booster intervention will be given over the phone at 1-week, 1month, 3-month, and 6 month follow-up.
15748091|NCT04875546|Other|Control|The adolescents will receive the leaflets for smoking cessation and alcohol abstinence. A booster intervention will be given over the phone at 1-week, 1month, 3-month, and 6 month follow-up.
15748096|NCT04875520|Other|Screening testing strategy|The intervention we are evaluating is the use of weekly screening testing among students and staff.
15748097|NCT04875520|Other|No screening testing strategy|a group of schools will not receive screening testing.
15748098|NCT04875507|Behavioral|Positive Psychology|This intervention aim to examine the effectiveness of PPI in reducing depressive symptoms, enhancing self-esteem, and promoting quality of life among Chinese children who are living in poverty. Participants in the experimental group will receive a 1.5 hour workshop on 4 positive psychology techniques, including (1) gratitude visit/letters, (2) 3 good things, (3) you at your best, and (5) using signature strengths. A booster intervention will be given at 1-week,1-, 3-, and 6-month follow-up.
15748099|NCT04875494|Behavioral|Counseling/support group therapy|6 weeks of counseling group therapy; 2 sessions of 30 min each week, with a psychologist and two former victims
15748100|NCT04875494|Behavioral|Physical Exercise|6 weeks of physical exercise training; 2 sessions of 30 min each week, with an instructor
15748101|NCT04875481|Other|Psychiatric diagnosis|Kiddie Schedule for Affective Disorders & Schizophrenia (K-SADS) for DSM-5
15748102|NCT04875481|Other|ASD diagnosis|Autism Diagnostic Interview-revised (ADI-R) and Autism Diagnostic Observation Scale (ADOS)
15748103|NCT04875468|Other|TheraCem self-adhesive resin cement|MDP, calcium and fluoride releasing cement for dental zirconia crowns
15748104|NCT04875468|Other|Multilink adhesive resin cement|(non MDP, non-calcium and fluoride releasing cement)
15748105|NCT04875455|Device|POD F GF (BVI Medical), POD F (BVI Medical), Panoptix (Alcon Inc) IOL implantation|In this study, patients have already received treatment, after receiving the consent, the routinely collected pre-, intra- and postoperative data will be pseudonymized and evaluated.
15748106|NCT04875442|Device|Memowave emitting sounds|Memowave is worn during one night and emits sounds to increase slow brain waves
15748107|NCT04875442|Device|Memowave not emitting sounds|Memowave is worn during one night and doesn't emit sounds
15748108|NCT04875429|Device|Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System|Endovascular aneurysm repair
15748109|NCT04875403|Other|Inspiratory muscle trainning|linear load device, associated with the resisted training. The initial training load for each participant will be adjusted to 25% of MIP. Each week, the researcher determines the new values for load (1 to week 25%, 2 to week 35%;. 3 to week 40%;. 4 to week 45%;. 5 to week 50%.).
15748110|NCT04875403|Other|Exercise|exercise bike for 30 minutes, which will be divided into 10 minutes for the foot heating and 20 minutes for the workout aerobic exercise that will have to maintain a target training heart rate
15748111|NCT04875390|Other|Erector spina plane block|After the surgery is completed, intraoperative Erector spina plane block will be performed
15748112|NCT04875390|Other|local infiltration|After the surgery is completed, intraoperative local infiltration will be performed
15748113|NCT04875377|Dietary Supplement|Reformulated pizza|Reformulated food with 400ug of iodine per meal, three times per week (to achieve 122% of weekly recommended intakes - average 140ug/day).
15748114|NCT04875377|Dietary Supplement|Control pizza|Control (placebo) meal to consume thrice weekly (no iodine supplementation).
15748115|NCT04875377|Dietary Supplement|Seaweed capsule|Capsules containing seaweed extract, the iodine-rich ingredient in the reformulated pizza, 400ug iodine per capsule, to be consumed three times per week (122% of weekly recommended intake).
15748116|NCT04875377|Dietary Supplement|Control capsule|Empty capsules (placebo)
15748117|NCT04875364|Drug|Eszopiclone|2mg of Eszopiclone just before going to sleep.
15748118|NCT04875364|Other|Supplemental Oxygen|Constant oxygen flow at 4 Liters per minutes for the duration of time in bed via nasal cannula.
15748119|NCT04875364|Device|Continuous Positive Airway Pressure (CPAP)|A standard CPAP device will be provided using the settings as prescribed by the treating physician.
15748120|NCT04875351|Diagnostic Test|Breast Cancer Index (BCI) Risk of Recurrence & Extended Endocrine Benefit Test|The BCI test provides a quantitative estimate of the risk for both late (post-5 years from diagnosis) distant recurrence and of the cumulative distant recurrence risk over 10 years (0-10y) in patients treated with adjuvant endocrine therapy (LN- patients) or adjuvant chemoendocrine therapy (LN+ patients), and prediction of the likelihood of benefit from extended (>5 year) endocrine therapy.
15748121|NCT04875338|Drug|plate-rich plasma|1ml prp (plate-rich plasma to be prepared with the blood taken from the patient on the day of injection), , while the patient is in the supine position, the affected elbow is 90 flexion and neutral rotation, The non-dominant thumb will be placed at the sensitive point in the lateral epicondyle. The injection will be applied to the point with a 23 g needle. After the injection, the subjects will be taught a stretching exercise of the joint extensors of the wrist and fingers. Subjects will be asked to do this exercise five times in one session, two sessions a day
15748154|NCT04875052|Device|Experimental: Whole Body Vibration|Whole body vibration will be delivered using a commercially available device at a frequency of 30Hz and acceleration of 2g for 1 minute a total of 6 times with 2 minutes of rest between exposures.
15748484|NCT04872530|Dietary Supplement|Whey protein concentrate|Whey protein concentrate
15748122|NCT04875338|Drug|saline (0.9 NACI)|1 ml saline (0.9 NACI) while the patient is in the supine position, the affected elbow is 90 flexion and neutral rotation, The non-dominant thumb will be placed at the sensitive point in the lateral epicondyle. The injection will be applied to the point with a 23 g needle. After the injection, the subjects will be taught a stretching exercise of the joint extensors of the wrist and fingers. Subjects will be asked to do this exercise five times in one session, two sessions a day
15748123|NCT04875338|Drug|betametazon|1 ml betametazon while the patient is in the supine position, the affected elbow is 90 flexion and neutral rotation, The non-dominant thumb will be placed at the sensitive point in the lateral epicondyle. The injection will be applied to the point with a 23 g needle. After the injection, the subjects will be taught a stretching exercise of the joint extensors of the wrist and fingers. Subjects will be asked to do this exercise five times in one session, two sessions a day
15748124|NCT04875325|Other|Standardized surveillance|Standardized 3-monthly surveillance with routine imaging and serum tumor marker testing.
15748125|NCT04875312|Device|Ultrasound cavitation in group A|"Group A:
~twenty obese infertile patients with PCO who will be treated by ultrasound cavitation, 2 times per week for 3 months with medical treatment and hypocaloric diet (1200 kcal/day)"
15748126|NCT04875312|Device|Electro acupuncture in group B|"Group B:
~twenty obese infertile patients with PCO who will be treated by electroacupuncture, 3 times per week for 3 months with medical treatment and hypocaloric diet (1200 kcal/day)"
15748127|NCT04875299|Other|The study is observational|The study is observational
15748128|NCT04875286|Other|Electronic Health Record Review|Medical records reviewed
15748129|NCT04875286|Other|Questionnaire Administration|Complete questionnaires
15748130|NCT04875273|Device|Magnetic Tape® aplicación|Magnetic tape® is applied without creating any tension on the paravertebral skin of the lumbar spine
15748131|NCT04875273|Device|Kinesiology Tape application|Kinesiology tape is applied without creating any tension on the paravertebral skin of the lumbar spine
15748132|NCT04875260|Other|Critical Care|Critical care in the intensive care units
15748133|NCT04875247|Device|IOLMaster 700 with central topography|The time needed to perform the measurement using the IOLMaster700 equipment with central topography will be recorded.
15748134|NCT04875247|Device|IOLMaster 700 without central topography plus Cassini|The time needed to perform the measurement using the IOLMaster700 equipment without central topography plus the Cassini equipment will be recorded.
15748135|NCT04875247|Device|IOLMaster 700 without central topography plus Pentacam|The time needed to perform the measurement using the IOLMaster700 equipment without central topography plus the Pentacam equipment will be recorded.
15748136|NCT04875234|Device|Clear-K Low Vision Aid Treatment|A Clear-K Low Vision Aid Device is used to produce small corneal shape and refraction changes in order to redirect light onto functional areas of the retina.
15748137|NCT04875221|Combination Product|Connectivity-based neurofeedback|Real-time fMRI neurofeedback will be used to non-invasively regulate neural network connectivity patterns associated with symptoms and emotional arousal among patients with PTSD and healthy individuals, with the aim to induce lasting neuronal effects and reduce symptoms.
15748139|NCT04875182|Diagnostic Test|Evaluation of Delirium development|Postoperative pain scores of the patients will recorded by using a numerical rating scale.
15748140|NCT04875169|Drug|Core Treatment Active Experimental: SHR0302 Dose#1|Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks
15748141|NCT04875169|Drug|Core Treatment Active Experimental: SHR0302 Dose#2|Drug: SHR0302 Oral tablets taken once daily (QD) for 16 weeks
15748142|NCT04875169|Drug|Core Treatment Placebo Comparator: Placebo|Drug: Placebo Oral tablets taken once daily (QD) for 16 weeks
15748143|NCT04875169|Drug|Extension Treatment Active Experimental: SHR0302 Dose#1|Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks
15748144|NCT04875169|Drug|Extension Treatment Active Experimental: SHR0302 Dose#2|Drug: SHR0302 Oral tablets taken once daily (QD) for 36 weeks
15748145|NCT04875156|Other|measurement of range of motion and strength|measurement of range of motion (goniometer) and strength (dynamometer) of the metacarpophalangeal joint of the thumb
15748146|NCT04875143|Dietary Supplement|Citrus aurantium L.|In the first intervention, the volunteers allocated to group I will take a capsule containing 500mg of starch, at the end of this, another capsule containing 500mg of Citrus aurantium L. will be provided for the second intervention.
15748147|NCT04875130|Diagnostic Test|blood samples|Taking blood samples (plasma, serum) and measure the level of Adrenomedullin
15748148|NCT04875117|Device|Hearing aid|One or two behind the ear hearing aids provided by the UK National Health Service.
15748149|NCT04875104|Device|Orthodontic treatment with Invisalign system|Patients are going to receive an orthodontic treatment with Invisalign aligners.
15748150|NCT04875104|Device|Orthodontic treatment with Spark system|Patients are going to receive an orthodontic treatment with Spark aligners.
15748151|NCT04875091|Behavioral|Ready SET Health|"This behavioral weight loss intervention will span 16 weeks. The first session (Week 1) will be a virtual Weight Loss 101 group kick-off followed by 15 weeks of a technology-mediated program consisting of the following: weekly emailed content (videos and readings explaining key skills and strategies to produce weight loss) and weekly emailed tailored feedback (based on self-monitoring data from participants). A trained interventionist (coach) will lead the group session, provide weekly tailored feedback, and monitor participant progress."
15748152|NCT04875078|Device|UVA-1 Phototherapy|UVA-1 Phototherapy treatments
15748153|NCT04875065|Behavioral|Engage coaching|"Participants will complete up to 8 weekly individual Social Engage psychotherapy sessions. Participants will be allotted up to 3 months to complete all sessions, a time-frame that allows for two weeks without meeting to address life stressors such as illnesses that may pop up. All sessions are provided via phone or videocall (Zoom). The first and last session are longer - up to 60 minutes if needed. Middle sessions are shorter (20-45 minutes). Engage is a stepped care psychotherapy in that the simplest strategy is taught first-action planning (a derivative of problem solving therapy)-and barrier strategies are added only if needed. Action plans are designed to address loneliness and social isolation in the context of caregiving demands."
15748253|NCT04874389|Diagnostic Test|Multimodal Assessment|Participants will complete BISQ/health questionnaire and proceed to each testing station with 15 minute rest breaks in between randomly ordered assigned stations.
15748156|NCT04875052|Other|Standard ACL Rehabilitation|Patients will complete a standard of care rehabilitation emphasizing restoration of early weight bearing, range of motion, quadriceps function, balance, and neuromuscular control.
15748157|NCT04875039|Drug|Dexamethasone|dexamethasone 2 mg will be added to the local anesthetic used to block the cords of the brachial plexus with an infraclavicular approach.
15748158|NCT04875039|Drug|Dexmedetomidine-Dexamethasone|A mixture of dexamethasone 2mg with dexmedetomidine 50mcg will be added to the local anesthetic used to block the cords of the brachial plexus with an infraclavicular approach.
15748159|NCT04875026|Drug|5-fluorouracil 4% (Tolak)|Application of Tolak once daily in the evening for 4 weeks
15748160|NCT04875026|Device|Dexeryl|Application of Dexeryl once daily in the morning for 8 weeks
15748161|NCT04875013|Device|Vestibular rehabilitation with dynamic posturography|Rehabilitation exercises guided by an interactive display and measured by a footplate sensor
15748162|NCT04875000|Other|Remineralizing agent I application|Application of UltraEZ remineralizing agent to the bleached teeth
15748163|NCT04875000|Other|Remineralizing agent II application|Application of 2.5% arginine solution to the bleached teeth
15748164|NCT04875000|Other|Remineralizing agent III application|Application of 2.5% nano-hydroxyapatite solution to the bleached teeth
15748165|NCT04874987|Other|Simulation based learning with Advocacy inquiry and ladder of influence|Simulation scenarios based on identified gender and equity gaps. We will explore experiences of male and female participants, and inter-professional simulation participants (e.g nurses and doctors, medical and nursing students) post intervention exposure on their role and experiences in simulated sessions and clinical care experiences
15748166|NCT04874974|Behavioral|Metacognitive and Defusion Training|Module I will give a brief introduction into the rational of the therapy and explain the terms cognitive biases and relational responding and their role in the development of psychological problems (psychosis) in a simple language and with the help of examples and small exercises. The principle of metacognition and cognitive defusion in psychotherapy will be made clear. An outlook on the procedures and the goals of the group therapy will be given. Module II will include interventions adapted from the MCT manual (Moritz et al., 2017) and Module III with consist of defusion strategies taken from the ACT group manual (Dambacher et al., 2020) and existing studies on ACT and psychosis (Bach et al., 2013; Gaudiano & Herbert, 2006).
15748167|NCT04874961|Dietary Supplement|Tensiofytol|standardized olive extract
15748168|NCT04874961|Dietary Supplement|Cholesfytol NG|combination preparation
15748169|NCT04874961|Other|Placebo|contains excipients only
15748171|NCT04874935|Drug|Lansoprazole|administration of lansoprazole 60 mg twice daily 4 days before starting neoadjuvant chemotherapy regimen and continue till end of chemotherapy cycles
15748172|NCT04874935|Drug|Placebo|administration of Placebo capsule twice daily 4 days before starting neoadjuvant chemotherapy regimen and continue till end of chemotherapy cycles
15748173|NCT04874922|Behavioral|Gestational Diabetes Training Intervention based on Planned Behavior Theory|On the basis of Planned Behavior Theory, an training intervention is planned in three stages for medical nutrition, physical activity and gestational diabetes follow-up.
15748174|NCT04874922|Behavioral|Gestational Diabetes Training Intervention based on standart|Standard training for gestational diabetes will be given once at 28 weeks of gestation.
15748175|NCT04874909|Other|Blood sample|"Blood sample of 15ml max by subject (case, related individual, control) once time:
~subject less than 5 kg : 1.8 to 4.5 ml max
~subject 5 kg to 10 kg : 4.5 to 9 ml max
~subject 10 kg to 15 kg : 9 to 13.5 ml
~subject 15 kg to 20 kg : 13.5 to 15 ml max"
15748176|NCT04874909|Other|Urine sample|Urine sample (500 ml) once time
15748177|NCT04874896|Dietary Supplement|Microbiota autotransplantation|Patients received microbiota autotransplantation in capsules (1g per day) for 6 months
15748178|NCT04874896|Dietary Supplement|Control|Patients will not received microbiota autotransplantation in capsules and will received usual medical care
15748179|NCT04874883|Dietary Supplement|Simbyotic|6 grams of the symbiotic will be administered twice a day
15748180|NCT04874883|Device|Control Group|6 grams of the maltodextrin will be administered twice a day
15748181|NCT04874870|Drug|Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex]|1 injection of 0.58mg will be injected into applicable cord.
15748182|NCT04874870|Combination Product|Xiaflex + Hand-Based Custom Orthosis|1 injection of 0.58mg will be injected into applicable cord followed by use of hand-based custom orthosis to maintain finger extension
15748183|NCT04874857|Other|Lavandula angustifolia, Rosmarinus officinalis L. and Origanum majorana L.|Massage application
15748184|NCT04874857|Other|Baby oil|Massage application
15748185|NCT04874844|Biological|Recombinant anti-VEGFR2 fully human monoclonal antibody (JY025)|"The ratio of subjects in the experimental drug group to the placebo control group is 1:1, and you will have a 50% probability of receiving JY025 combined with gefitinib or erlotinib, and a 50% probability of receiving placebo combined with gefitinib Or erlotinib.
~Blind people, researchers, nurses, research assistants, inspectors, applicants and blind statisticians involved in clinical trials."
15748186|NCT04874831|Drug|domatinostat in combination with avelumab|domatinostat tablets and avelumab infusion
15748187|NCT04874818|Diagnostic Test|[89Zr]Df-IAB22M2C PET/CT scan|PET imaging procedure
15748188|NCT04874805|Other|Measurement of oxygen saturation|Measurement of oxygen saturation by pulse oximetry once a day, at 6 a.m., for a minimum of 3 days, thanks to three pulse oximeters (1 measurement point per device/day), in parallel with a synchronous sampling, programmed as part of the usual care, of arterial gasometry.
15748189|NCT04874779|Other|non|follow up investigations
15748192|NCT04874753|Other|change in kidney function and proteinuria|change in eGFR nad proteinuria in patients with chronic kidney disease
15748193|NCT04874740|Other|No intervention|No intervention
15782466|NCT04593329|Other|TRAMADOL PLACEBO|Tramadol placebo capsule
15748194|NCT04874727|Procedure|Mandible slacked and captured with Correct Plus™ Impression Material Superfast|In order to simulate the supine position, patients are placed in a supine position (180 degrees) in a dental exam chair, and asked to relax their lower jaw, allowing it to drop back, simulating their jaw falling back while sleeping. That bite is then captured with a Correct Plus™ Impression Material Superfast. Once the bite material hardens, it locks the bite in place. The patient then stands upright, and CBCT is taken standing while the jaw placement is still pseudo sleep-supine, supported by the bite material.
15748195|NCT04874714|Biological|MM09-MG01(30.000-30.000)|Mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae) with a concentration of 30,000 AU / mL and grasses mixture (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca elatior, Lolium perenne and Dactylis glomerata) with a concentration of 30,000 AU / mL: Purified allergenic extract, adsorbed in aluminum hydroxide and polymerized with glutaraldehyde
15748196|NCT04874714|Biological|MG01(30.000)|Grasses mixture (Phleum pratense, Holcus lanatus, Poa pratensis, Festuca elatior, Lolium perenne and Dactylis glomerata) with a concentration of 30,000 AU / mL: Purified allergenic extract, adsorbed in aluminum hydroxide and polymerized with glutaraldehyde
15748197|NCT04874714|Biological|MM09(30.000)|Mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae) with a concentration of 30,000 AU / mL: Purified allergenic extract, adsorbed in aluminum hydroxide and polymerized with glutaraldehyde
15748198|NCT04874714|Biological|Placebo subcutaneous|The same solution, presentation, method of administration, frequency, and duration as the active treatment, but without active ingredients.
15748199|NCT04874701|Drug|Capsimax|Capsimax, 2 capsules per day, for 12 weeks Medicinal ingredient: Capsicum annuum Quantity (per capsule): 100.0 mg
15748200|NCT04874701|Other|Energy restriction|Personalised diet plan targeting a 500 kcal/day energy restriction
15748201|NCT04874688|Dietary Supplement|Small-quantity lipid-based nutrient supplement|Small Quantity Lipid-based Nutrient Supplement (SQ-LNS) is a food supplement rich in both macro and micronutrients (calories, proteins, fat and multivitamin mix). SQ-LNS is not considered a regulated drug product in Zimbabwe, or by the United States Food and Drug Administration (FDA). It is commercially available for prevention of chronic malnutrition, produced by Nutriset (https://www.nutriset.fr/products/en/enov-nutributter2). Each child will receive a daily sachet of 20g SQ-LNS between 6-12 months of age, consumed directly from the sachet or mixed with porridge.
15748202|NCT04874688|Dietary Supplement|Provitamin A biofortified maize|Provitamin A Maize Meal is orange maize-meal processed from provitamin A-rich orange maize. PVA maize meal will be sourced from International Maize and Wheat Improvement Centre (CIMMYT). Children in the intervention arm will consume 13g - 128g of pro-vitamin A (PVA) maize meal, with added powders. Each family will receive a monthly ration of 5kg PVA maize and this ration takes into consideration of household sharing. Families with children in the IYCF arm will receive white maize meal.
15748203|NCT04874688|Dietary Supplement|NUA-45 biofortified sugar beans|NUA 45 bean powder is ground from roasted iron and zinc-rich biofortified sugar beans. NUA 45 bean powder will be sourced from Sky Brands Ltd Company. Children will consume a daily dose of 5g - 15g of NUA 45 bean powder added to complementary foods.
15748204|NCT04874688|Dietary Supplement|Moringa oleifera|Moringa oleifera is an edible plant abundant in dry tropic regions including Zimbabwe. It is known to be rich in micronutrients and has been widely used in Zimbabwe and around the world both as a food and a herb. Moringa oleifera leaf powder, is a dried and ground powder produced from Moringa oleifera leaves using traditional methods. It has been widely used to fortify complementary foods in the African region with the aim of improving micronutrient status. Moringa oleifera leaf powder will be sourced from Lemex Products Company. Children will receive a daily dose of 5g - 15g of Moringa leaf powder added to complementary foods.
15748205|NCT04874688|Dietary Supplement|Whole egg powder|Egg Powder is hydrolysed non-genetically modified organism (GMO), fine and unflavoured whole egg powder. It is processed with no additives, preservatives, lecithin, added sugar, soy or monosodium glutamate. Egg powder will be sourced from France (A & D Food Ingredients - distributor in South Africa). Children in the IYCF-plus arm will receive a daily dose of 14g egg powder. A 15% extra amount of egg powder will be provided to families taking into consideration of household sharing. Egg powder will be provided in sealed plastic jars similar to that of peanut butter and households will receive promotion messages to store the powder in a cool, dry place and avoiding contact with water or moisture during use.
15748206|NCT04874688|Dietary Supplement|White maize meal|Commercial white maize meal will be provided monthly. Infants age 6-8 months will receive 45g (3 tablespoons) daily; infants aged 9-12 months will receive 71g (4.5 tablespoons) daily.
15748207|NCT04874675|Drug|diclofenac / acetaminophen /codeine|routine pain medication used post extraction of third molars
15748208|NCT04874675|Drug|ibuprofen/acetaminophen/codeine|routine pain medication used post extraction of third molars
15748209|NCT04874662|Dietary Supplement|NAM/B6|Single daily dose administration will take place from Day 0 (V1) to Day 8 (V4) around 8 am after an overnight fast from the subsequent evening at 9 pm.
15748210|NCT04874649|Other|Balloon-blowing breathing|Participant sit on a chair. Inhale fully through their nose and hold for a full 3 second inhalation, then exhale through their mouth into the balloon fully. By having the balloon inflate until their touch the balloon size control device and hold the exhalation period for 1 second, cover the balloon immediately with your fingers count as 1 breath cycle, then replace the balloon immediately. Do this for 3 consecutive rounds, counted as 1 set, in each training, do a total of 3 sets, rest between sets for 1 minute, which takes about 15 minutes, 5 times per week for 8 weeks
15748211|NCT04874649|Other|Sustained maximal inspiration breathing|Participant sit on a chair. Inhale through their nose fully and hold for 3 seconds for a full breath, Do this for 3 consecutive rounds, counted as 1 set, in each training, do a total of 3 sets, rest between sets for 1 minute, which takes about 15 minutes, 5 times per week for 8 weeks
15748214|NCT04874623|Other|Collection of peripheral blood mononuclear cells|Analysis of specific memory B cells in CDI patients
15748215|NCT04874610|Drug|Methylprednisolone|Administration of methylprednisolone Prescribed per Standard of care
15748216|NCT04874597|Drug|Ocrelizumab|Ocrelizumab treatment will be administered in accordance with the product characteristics approved in Turkey.
15748254|NCT04874376|Device|IOL implantation experimental (Isopure 1.2.3.)|Implantation of Premium Monofocal Isopure 12.3 with retrospective data collection
15748219|NCT04874571|Other|Muscle Energy Technique group|In addition to the home exercise program of 12 sessions for 4 weeks, 3 days a week, muscle energy technique will be applied to the individuals in the MET(Musculer Energy Technique) group.
15748220|NCT04874558|Diagnostic Test|Ultra-low dose chest CT|A novel CT technique with a new dose optimization and efficiency technology and automatic kV selection, which greatly reduces the dose of radiation exposure compared to a standard chest CT.
15748221|NCT04874545|Drug|Propofol|Total intravenous inhalational anesthesia
15748224|NCT04874519|Behavioral|Questionnaire|The questionnaire will be completed at the time of enrollment, every month, and at the end of study. Regardless of current interventions or lack of, assessments will be completed at enrollment and then monthly for a total of 18 months. In order to provide reasonable flexibility to participants, physicians, and study teams, the assessments can be completed within 30 days of the last assessment. The next month will be recalculated based on last reporting date.
15748225|NCT04874506|Drug|MBM-02|Study drug will be administered orally using the capsule formulation (200 mg). The study drug will be administered 7 days a week for the entire treatment period.
15748226|NCT04874493|Other|Electronic Health Record Review|Review of medical records
15748227|NCT04874493|Other|Questionnaire Administration|Complete questionnaire
15748228|NCT04874480|Drug|Decitabine|Given IV
15748229|NCT04874480|Drug|Tegavivint|Given IV
15748230|NCT04874467|Procedure|Supportive periodontal therapy|"A complete professional prophylaxis session will be performed, which includes ultrasound debridement, scaling with curettes and dental polishing with a rubber cup. On the other hand, in implants affected by mucositis, supra and sub-gingival debridement will be performed using a combination of ultrasound with a titanium tip and titanium curettes.
~All patients will receive personalized hygiene instructions. Patients will be instructed to brush their implants twice daily using the modified Bass technique with a medium-hard manual toothbrush and low-abrasive toothpaste. In addition, they will be taught to use specific interproximal brushes. If access with an interdental brush is not possible, flossing will be indicated. Oral hygiene instructions will be reviewed at each visit."
15748231|NCT04874454|Diagnostic Test|ultrasound|evaluate the vocal cord movement among the stroke patients
15748232|NCT04874441|Diagnostic Test|Diagnosis strategy based on C. glabrata / krusei PCR|For diagnosis, a blood cultures and blood tubes for PCR will be collected and patients will be treated with echinocandins in the first instance with an early switch to fluconazole if the C. glabrata / krusei PCR is negative
15748233|NCT04874428|Drug|Rivaroxaban 10 mg Oral Tablet|Administration of one single dose of rivaroxaban (10 mg) in tablet form.
15748234|NCT04874428|Drug|Apixaban 2.5 mg Oral Tablet|Administration of one single dose of apixaban (2.5 mg) in tablet form.
15748235|NCT04874415|Behavioral|1RLD|1RLD=One text per day, ramped goal, loss incentive, daily goal time period
15748236|NCT04874415|Behavioral|1RLW|1RLW=One text per day, ramped goal, loss incentive, weekly goal time period.
15748237|NCT04874415|Behavioral|1RGD|1RGD=One text per day, ramped goal, gain incentive, daily goal time period.
15748238|NCT04874415|Behavioral|1RGW|One text per day, ramped goal, gain incentive, weekly goal time period.
15748239|NCT04874415|Behavioral|2RLD|Two texts per day, ramped goal, loss incentive, daily goal time period.
15748240|NCT04874415|Behavioral|2RLW|Two texts per day, ramped goal, loss incentive, weekly goal time period.
15748241|NCT04874415|Behavioral|2RGD|Two texts per day, ramped goal, gain incentive, daily goal time period.
15748242|NCT04874415|Behavioral|2RGW|Two texts per day, ramped goal, gain incentive, weekly goal time period.
15748243|NCT04874415|Behavioral|1FLD|One text per day, fixed goal, loss incentive, daily weekly goal time period.
15748244|NCT04874415|Behavioral|1FLW|One text per day, fixed goal, loss incentive, weekly goal time period.
15748245|NCT04874415|Behavioral|1FGD|One text per day, fixed goal, gain incentive, daily goal time period.
15748246|NCT04874415|Behavioral|1FGW|One text per day, fixed goal, gain incentive, weekly goal time period.
15748247|NCT04874415|Behavioral|2FLD|Two texts per day, fixed goal, loss incentive, daily goal time period.
15748248|NCT04874415|Behavioral|2FLW|Two texts per day, fixed goal, loss incentive, weekly goal time period.
15748249|NCT04874415|Behavioral|2FGD|Two texts per day, fixed goal, gain incentive, daily goal time period.
15748250|NCT04874415|Behavioral|2FGW|Two texts per day, fixed goal, gain incentive, weekly goal time period.
15748251|NCT04874402|Procedure|Prepectoral approach|Two sheets of contour, fenestrated ADM sutured together are trimmed in accordance with the measurement of the expander/implant and fixed to the pectoralis major muscle (superiorly, medially, and inferiorly) and serratus fascia (laterally), covering the entire anterior surface of the device
15748252|NCT04874402|Procedure|Partial Subpectoral approach|The leading edge of the pectoral muscle is elevated and a subpectoral pocket is fashioned. The lower medial origin muscle fibers are released for anatomical expander seating. An ADM sling is sutured from the leading edge of the pectoralis muscle to the inframammary fold (over the expander) and laterally to close the expander pocket. In both groups, the size of the expander and the intraoperative filling volume will be decided by the attending surgeon based on the pocket dimension and volume capabilities.
15748255|NCT04874363|Other|no intervention|no intervention
15748256|NCT04874350|Drug|LPCN 1148|LPCN 1148 is an oral capsule product containing an ester prodrug of bioidentical testosterone, designed to enable absorption via intestinal lymphatics.
15748257|NCT04874350|Drug|Placebo|Oral matching placebo capsule
15748258|NCT04874337|Other|Disaster nursing and management training will be given to students using Jenning's Disaster Nursing and Management Model.|The subjects for the training program were prepared by the researchers by scanning the relevant literature. In particular, the ICN Framework of Disaster Nursing Competencies developed by the International Nurses Association (ICN) and the World Health Organization (WHO), the second is the universal standards that should be fundamental in nursing and midwifery education (Global Standards for the Initial Education of Professional Nurses and Midwives). The training program was conducted both theoretically and practically. The theoretical section is based on Jenning's disaster nursing management model. Investigator is a First and Emergency Aid instructor. In addition, support was received from an experienced psychologist and AFAD trainers who provided support to the victims of the Izmir earthquake during the training process. In this context, an 8-module training program was created.
15748259|NCT04874324|Drug|WCK 2349 Oral|1 dose given orally twice daily at 12 hourly interval for five days.
15748260|NCT04874324|Other|Placebo Oral|Subjects will receive matching placebo
15748261|NCT04874311|Drug|Bintrafusp alfa|Bintrafusp alfa will be administered by intravenous infusion on day 1 every 3 weeks at a fixed dose of 2400 mg.
15748262|NCT04874311|Drug|Doxorubicin|Doxorubicin will be administered by intravenous infusion on day 1 every 3 weeks at a fixed dose of 75 mg/m² for a maximum of 6 cycles
15748263|NCT04874298|Other|Ginger|Patients who meet the inclusion criteria and agree to participate in the study will be assigned to the experimental group. In the postoperative period at the 2nd, 4th, 6th, 12th and 24th hours, the patient will use Ginger and Peppermint oil as inhalation. The structure of the inhaler tube is explained. The back cover of the inhaler tube is opened and absorbent cotton swab is inserted into it. Cotton swab 1 ml of essential oil is added by dropping on it. The back cover of the inhaler tube is closed. It is waited for 10-15 minutes. The front cover of the inhaler tube is opened at the time intervals specified in the study procedure (at the 2nd, 4th, 6th, 12th and 24th hours after the operation, and the patient is allowed to smell essential oil from the tube. With the end of the sniffing process, the front cover of the tube is closed and the essential oil remains in the tube. The essential oil tubes to be applied will be prepared separately for each patient and that day.
15748264|NCT04874298|Other|Peppermint|Peppermint
15748265|NCT04874285|Dietary Supplement|HA|hyaluronic acid, alpha-lipoic acid, vitamin D and vitamin B6
15748266|NCT04874272|Other|Chaplain led post-code debrief|an emotional debrief (a discussion to process the emotional, existential impact of a medical code/cardiopulmonary arrest), which will be led by a chaplain
15748267|NCT04874259|Procedure|Living donor liver transplantation|Living donor liver transplantation
15748268|NCT04874246|Drug|Vasopressin|During robot-assisted laparoscopic myomectomy, vasopressin diluted to different concentrations will be injected before uterine serosal incision.
15748269|NCT04874233|Drug|HU6|HU6 is designed to reduce the steatosis, inflammation, fibrosis and hepatocyte injury in Noncirrhotic Nonalcoholic Steatohepatitis (NASH)
15748270|NCT04874233|Drug|Placebo|Non-active study drug N = 20
15748271|NCT04874220|Device|Deep Brain Stimulation|Deep brain stimulation will be used
15748272|NCT04874207|Drug|Pharmacokinetics|Dose adaptation at the beginning of cycle 2 and cycle 3 after regorafenib dosage at day 15
15748273|NCT04874194|Drug|Omacetaxine Mepesuccinate|Given SC
15748274|NCT04874194|Drug|Venetoclax|Given PO
15748275|NCT04874181|Device|Silverfit 3D|Virtual reality game used for rehabilitation of stroke patients
15748276|NCT04874168|Device|TAP block|bilateral ultrasound-guided TAP block was performed using a 12-4-MHz linear array transducer (ClearVue 350; Philips, Bothell, WA) placed transversely between the iliac crest and costal margin in the anterior axillary line and slid medial-lateral to visualize the external oblique, internal oblique, and trans-versus abdominis muscles; the most lateral (posterior) position obtaining a satisfactory ultrasound image was used
15748277|NCT04874155|Device|NTX100 Neuromodulation System - Active|Noninvasive peripheral nerve stimulation device programmed to active mode.
15748278|NCT04874155|Device|NTX100 Neuromodulation System - Sham|Noninvasive peripheral nerve stimulation device programmed to sham mode.
15748279|NCT04874142|Drug|YYC506-T|single administration
15748280|NCT04874142|Drug|YYC506-A|single administration
15748281|NCT04874142|Drug|YYC506-T + YYC506-A|concomotant administration
15748282|NCT04874142|Drug|YYC506-A + YYC506-T|concomotant administration
15748283|NCT04874129|Drug|YYC506-T and YYC506-A (phase 1)|Comparator
15748284|NCT04874129|Drug|YYC506 (phase 1)|Test
15748285|NCT04874129|Drug|YYC506-T and YYC506-A (phase 2)|Comparator
15748286|NCT04874129|Drug|YYC506 (phase 2)|Test
15748287|NCT04874116|Behavioral|Office Guidelines Applied to Practice (Office-GAP) + Mobile text messaging|Office-GAP incorporates shared decision-making and a decision/support checklist to be completed during office visits, to foster patients' investment in their own care. Way to Health is a cell phone messaging service that informs and encourages patients to adhere to goals and improve communication.
15748288|NCT04874116|Behavioral|Mobile text messaging|Way to Health is a cell phone messaging service that informs and encourages patients to adhere to goals and improve communication.
15748289|NCT04874090|Other|Acupuncture|Investigator will apply the acupuncture treatment to the first group to the neck area. BL-15, BL-18, BL-23, BL-25, KB-4, Du-20, GB-20, CV-14, KB-10, Ex-26, Yin Tang, Ah-shi points will be used. 0.25x25 mm, sterile, steel, disposable, acupuncture needle will be used for acupuncture points and painful trigger points. The treatment will be applied twice a week, on average 10 sessions. Dry needling treatment will be applied to the patients by a certified physician. All patient will be performed the neck exercises program
15748290|NCT04874090|Other|Exercises|Patient will perform neck exercises
15748291|NCT04874064|Other|Liquid Biopsy|Blood collection and access to residual tumor.
15748318|NCT04873817|Device|IonicRF Generator andcompatible accessories|Participants will recieve IonicRFRF lesion generator, along with any country-specific market-released accessory (i.e. electrode,cannula, grounding pad, and adaptor cable) compatible with theIonicRF Generator
15748582|NCT04871776|Behavioral|Usual Care|Usual messaging sent by Mass General Brigham
15748292|NCT04874051|Device|Experimental Group|The experimental treatment will be provided by means of the OAK system. This device consists of 1 cabinet with 2 independent balance boards, 2 monitors (one for the physiotherapist and one for the patient) and 3 wireless IMUs (one for the left lower limb, one for the right lower limb and one for the trunk). The 2 balance boards provide body weight transfer exercises, while the wireless motion sensors provide one leg stance exercises or trunk exercises in a virtual environment.
15748293|NCT04874051|Other|Control Group|The Control Group will perform conventional balance exercises similar to the exercises provided with the OAK system.
15748294|NCT04874038|Drug|Lidocaine 20mg/ml|Patients in the intervention group will receive an IV lidocaine infusion using a dosage regimen of 1.5 mg/kg bolus of a 2% lidocaine solution with induction of general anesthesia followed by a 2.0 mg/kg/hour infusion until the end of surgery (and up to 30 minutes into recovery room).
15748295|NCT04874038|Drug|Placebo|Patients in the control group will receive a placebo bolus and infusion with normal saline (0.9% sodium chloride solution) until the end of surgery (and up to 30 minutes into recovery room).
15748296|NCT04874025|Drug|Ibrance|Observational study of Ibrance 75 mg, 100 mg and 125 mg.
15748297|NCT04874012|Drug|Active comparator Taurine|Participants will receive 3 g taurine, twice a day, as a powder for oral suspension (3 g/packet) for 12 weeks. Participants will be recommended to take the taurine immediately before the breakfast and dinner.
15748298|NCT04874012|Other|Placebo Comparator|Participants will receive the same treatment regimen and intake recommendation, but packets with the same appearance and size from those taurine ones will contain a vehicle
15748299|NCT04873986|Diagnostic Test|Scoliosis Tele-Screening Test|Scoliosis Tele-Screening test will be applied to children by parents at home. Participants with moderate and high risks will be invited to the physical examination to the centers or virtual assessment via e-mail. The researchers will be evaluated the TRACE and Adams' test from the photo and sent their opinions to the parents via e-mail.
15748300|NCT04873973|Other|Telemedical support|The nursing homes participating in the project will be equipped with telemedical equipment. This will allow teleconsultations to take place when needed. In addition, an early warning system will be introduced and, within the framework of the teleconsultation, a trained medical assistant can be sent to the care facility if necessary, who can carry out medical activities on site under a physician's delegated instructions. In addition, an electronic patient file will be introduced which can be accessed by the telemedicine physician and the general practitioner.
15748301|NCT04873947|Device|Pulse Oximeter|The investigational device will be placed on the finger of the left or right hand per the instructions for use. Simultaneous data collection will be set up for the system under test and control oximeter.
15748302|NCT04873934|Drug|Inclisiran|Inclisiran sodium 300 mg / 1.5 ml (equivalent to 284 mg of inclisiran)
15748303|NCT04873921|Other|sterile kinesio taping|Application area will be cleaned and dried prior to application to increase the adhesiveness of the tape and application will be done by an experienced physiotherapist during ACLR surgery.
15748304|NCT04873908|Other|modified constraint-induced therapy|Patients received conventional rehabilitation and modified constraint-induced therapy schedule
15748305|NCT04873908|Other|Proprioceptive Training|Patients received conventional rehabilitation and Proprioceptive Training schedule
15748306|NCT04873908|Other|conventional rehabilitation|Patients received conventional rehabilitation schedule
15748307|NCT04873895|Drug|Axitinib 5 MG|axitinib 5 mg po BID until progression or intolerance
15748308|NCT04873895|Drug|Hydroxychloroquine Pill|hydroxychloroquine 600 mg po BID until progression or intolerance
15748309|NCT04873895|Procedure|trans arterial chemoembolization|segmental or lobar TACE at 4-8 week intervals until entire tummy burden is treated.
15748310|NCT04873882|Device|Acoustic ventilation|"Placement and removal of the esophageal stethoscope
~Connection of a microphone to the esophageal stethoscope outside of and removed from the patient's body at the location on the figure above Connection fo monaural earpiece.
~Digital breath sound real-time monitoring will be collected as .wav files from the device with no identifiable elements and the data from the device will be downloaded onto a desktop and we will keep and store the data on a secure departmental server.
~Additional monitoring schedule includes evaluation of breath sounds with a conventional stethoscope every 30 minutes intraoperatively, at the start of one-lung ventilation, at the return to two-lung ventilation and prior to extubation and during any changes on the digital breath sounds recording monitor."
15748311|NCT04873869|Drug|NBI-921352|Administered orally
15748312|NCT04873869|Drug|Placebo|Administered orally
15748313|NCT04873856|Dietary Supplement|Intervention|"The four dimensions of MINDNUT are described below:
~Nutritional plan: is conducted in collaboration with the participant based on nutritional registration and information about routines and habits to reach a daily protein target of 1.5 g/kg/day. The nutritional plan is adjusted at the regular contact, and nutritional supplementation will be handed out to the participant.
~Friendly reminder/informal caregiver: is a friendly reminder that encourage the participant to follow the nutritional plan and to ask for support (a note to hang on the refrigerator). The informal caregiver is a person with close contact to the participant.
~Regular contacts: The participant will be contacted on regular basis (with an interval of 7-14 days) via phone and besides nutritional plan, this conversation will be used to talk about well-being, compliance and potential side-effects.
~Weight diary: participants is instructed in keeping a weight diary which include registration of a daily weight."
15748314|NCT04873843|Behavioral|Functional digital game training group|Functional digital game training group is divided in 16 participants. In one session, participants in the functional digital game training group completed 40 minutes of intervention using various functional digital game such as working memory, memory, and attention. (Total 10 session)
15748315|NCT04873843|Behavioral|Individual cognitive training|Functional digital game training group is divided in 16 participants. In one session, participants in the individual cognitive training group completed 40 minutes of intervention using various cognitive training such as working memory, memory, and attention. (Total 10 session)
15748316|NCT04873830|Biological|volume stable collagen matrix placement|volume stable collagen matrix placement to augment the buccal defect.in class I siebert at the same time of implant placement
15748317|NCT04873830|Procedure|connective tissue grafting|connective tissue placement to augment the buccal defect.in class I siebert at the same time of implant placement
15748388|NCT04873219|Device|manufacturing a complete dental prosthesis|dental treatment to replace missing teeth
15748319|NCT04873804|Other|Transcranial Direct Current Stimulation|The intervention protocols were applied using tDCS (Teknofil TESsaNova). All individuals received 2 mA of anodal tDCS for 2 weeks on weekdays. All applications were done in the form of 20-minute sessions.
15748320|NCT04873791|Diagnostic Test|Assessment of geriatric individuals living in home environment and nursing home.|Assessments explained in the arm section were made as described in one session in both group
15748321|NCT04873778|Device|Kinesio taping|Kinesio taping: Invented by Japan Dr.Kase, increase circulation by creating lifts skin,release pain and inflammation, stabilize joints
15748322|NCT04873778|Device|Dynamic taping|Dynamic taping: Invented by Kendrick,elasticised with multi-directional rebound and with strong elastic resistance and recoil than KT
15748323|NCT04873765|Biological|Pegfilgastrim Megalabs|Administration of 6 mg of Pegfilgrastim Megalabs subcutaneous single dose
15748324|NCT04873765|Biological|Pegfilgastim Amgen|Administration of 6 mg of Pegfilgrastim Amgen subcutaneous single dose
15748325|NCT04873752|Biological|UDI-001|2.5 x 10^6 cells/kg of UDI-001 are administered intravenously. One cycle consists of twice a week administrations.
15748326|NCT04873739|Diagnostic Test|Anterior Segment OCT|AS-OCT for SLE patients with dry eye, SLE patients without dry eye and compare them with normal subjects.
15748327|NCT04873726|Device|Magnetic Tape® aplication|Magnetic tape® is applied without creating any tension on the lumbar paravertebral skin to assess changes in pupil size
15748328|NCT04873726|Device|Kinesiology Tape|Kinesiology tape is applied without creating any tension on the lumbar paravertebral skin to assess changes in pupil size
15748329|NCT04873713|Device|Magnetic Tape® aplicación|Magnetic tape® is applied without creating any tension over low back
15748330|NCT04873713|Device|Kinesiology Tape|Kinesiology Tape is applied without creating any tension over low back
15748331|NCT04873687|Device|External Counter Pulsation (ECP) therapy|ECP therapy consist of 36 session, each session @1 hour/day, six days a week with initial pressure of 300mmHg
15748332|NCT04873674|Other|ASD diagnosis|Autism Diagnostic Interview-revised (ADI-R) and Autism Diagnostic Observation Scale (ADOS)
15748333|NCT04873674|Other|Psychiatric diagnosis|Kiddie Schedule for Affective Disorders & Schizophrenia (K-SADS) for DSM-5
15748334|NCT04873661|Behavioral|Hypnosis group intervention|See arm description
15748335|NCT04873661|Behavioral|Cognitive trance group intervention|See arm description
15748336|NCT04873661|Behavioral|Meditation group intervention|See arm description
15748337|NCT04873648|Behavioral|caloric reduced -intermitted fasting diet|obese women with food addiction and binge eating follow intermittent calorie restriction diet ( time-restricted eating - typically 16 -hour fasting and 8-hour eating)
15748338|NCT04873648|Behavioral|Daily calorie restriction|obese women with food addiction and binge eating disorder follow a Daily calorie restriction diet
15748339|NCT04873648|Behavioral|Control group|obese women without food addiction and binge eating disorder follow a Daily calorie restriction diet
15748340|NCT04873635|Other|Implant support prostheses|Implant support prostheses was provided to restore the missing teeth and tissues removed due to pathological jaw lesions
15748341|NCT04873622|Behavioral|RESTORE: Recovering from Extreme Stressors Through Online Resources and E-health|RESTORE (www.restoreonline.ca) includes eight e-modules anticipated to be approximately 30-40 minutes each in length and intended to be completed over 4-8 weeks. The modules address cognitive and behavioural factors posited to cause and maintain psychological distress related to the COVID-19 pandemic. These include cognitions about the cause and meaning of stressors related to the pandemic, including self-blame, other blame and hindsight bias, as well as problematic beliefs related to safety, trust, and control. The modules also address the importance of: (1) expressing emotions that are natural to the events of the pandemic (e.g., sadness in the face of loss), (2) working through, rather than avoiding, thoughts, feelings and grief related to the pandemic, and (3) utilizing social supports. The modules consist of written materials, brief videos, and practice assignments delivered through the platform. RESTORE includes guidance via direct messaging and/or brief telephone calls.
15748342|NCT04873609|Behavioral|Patient portal message|Direct-to-patient message via the electronic patient portal (MyHealth) with HCV antibody lab order directed to their preferred laboratory
15748343|NCT04873596|Drug|Nebulized dexmedetomidine|parturient will receive nebulized 3ug/kg dexmedetomidine.
15748344|NCT04873596|Drug|Nebulized midazolam|parturient will receive nebulized 0.2 mg/kg midazolam.
15748345|NCT04873583|Drug|Methylprednisolone|At the time of inclusion, intravenous Methylprednisolone for 3 days. Dose: 30 mg/kg/day BW (max. 1000 mg/dose)
15748346|NCT04873583|Drug|Prednisolone|"Intravenous treatment will be immediately followed by oral tapering with Prednisolone.
~Oral Prednisolone, 2 weeks (week 1 and 2) Dose: 1 mg/kg/day (max 40 mg/day) Oral Prednisolone, 2 weeks (week 3 and 4) Dose: 0.5 mg/kg/day (max 20 mg/day)"
15748347|NCT04873570|Drug|Moxifloxacin 400mg|Moxifloxacin 400mg IR tablet
15748348|NCT04873557|Other|Copper-based surfaces plus copper-enriched linen|We will assess the efficacy of our intervention to decrease the acquisition of nasal and intestinal colonization with MDROs and the development of HAIs in the ICU setting.
15748349|NCT04873544|Procedure|ERAS protocols for TKA|ERAS protocols for TKA
15748350|NCT04873531|Drug|Neostigmine|"For the N group, neostigmine (0.03 mcg / kg) and glycopyrrolate with a 5:1 ratio will be administered just after tracheal intubation.
~Investigators evaluate the quality of signal of IONM during the surgery."
15748351|NCT04873531|Drug|Normal saline|"For the NS group, neostigmine normal saline (0.09 cc/kg; the same volume of the group N) will be administered just after tracheal intubation.
~Investigators evaluate the quality of signal of IONM during the surgery."
15748352|NCT04873505|Dietary Supplement|troches|Take one troche after each meal.
15748353|NCT04873492|Other|Biological sample collection|Venous blood sample will be collected from patients belonging to validation cohort and healthy volunteers at baseline resulting in 90 Ml EDTA tube and 10 ml serum tube. Approximately 100 ml will be collected. optional saliva and stool collection will be performed.
15748354|NCT04873479|Drug|S-ketamine|Participants in the test group received midazolam 0.05-0.1mg /kg, sufentanil 0.1-0.2ug/kg,Etomidate 0.1-0.2mg/kg, cisatracurium 0.15-0.3mg/kg, S-ketamine 0.125mg/kg (low dose) for Anesthesia induction, followed by an infusion of remifentanil 0.05-0.15ug/kg/min and S-Ketamine 0.125mg/kg/h (low dose) and continuous inhalation of sevoflurane at 2-3%.
15748451|NCT04872712|Procedure|Filiform Needles|Manual acupuncture using filiform needles
15748355|NCT04873479|Other|saline|Participants in the control group received midazolam 0.05-0.1mg /kg, sufentanil 0.1-0.2ug/kg,Etomidate 0.1-0.2mg/kg, cisatracurium 0.15-0.3mg/kg, saline 0.125ml/kg for Anesthesia induction, followed by an infusion of remifentanil 0.05-0.15ug/kg/min and saline 0.125ml/kg/h and continuous inhalation of sevoflurane at 2-3%.
15748356|NCT04873466|Dietary Supplement|Enzyme-rich malt extract|Enzyme-rich malt extract (ERME) is a by-product of the malting process in which the cereal grain barley is dried. The ingredients are 100% barley malt extract. It smells and tastes sweet, with a runny jam-like texture. Malt extract has been used as a food stuff in baking and cookery for many years, but ERME is extracted by means which retains more active enzymes, such as amylase.
15748357|NCT04873453|Drug|Cannabidiol|The current study will directly test the hypothesis that a moderate dose of CBD leads to a reduction in alcohol consumption, alcohol craving, peripheral markers of inflammation, and anxiety.
15748358|NCT04873453|Drug|Placebo|Placebo arm
15748359|NCT04873440|Drug|Manganese Chloride|Administered by inhalation at 0.4mg/kg/d twice a week
15748360|NCT04873440|Radiation|Radiotherapy|Measurable lesions were targeted for radiotherapy at the discretion of the treating physician.Standard-of-care radiotherapy or SBRT were both allowed.
15748361|NCT04873440|Drug|Chemo-immunotherapy|The same chemotherapy and/or anti-PD-1 therapy before thei patients' enrolment were allowed. Whether and which should be given depends on the treatment regimen before enrollment.
15748362|NCT04873427|Genetic|clonal heterogeneity evaluation|Reconstruction of local PCa heterogeneity in multi-needle diagnostic biopsy with different Gleason scores (6-10) using high-coverage whole exome sequencing (WES) and DP-based clonal analysis
15748363|NCT04873414|Biological|Convalescent plasma treatment|Convalescent Plasma collected from patients who recover from COVID-19 and have been discharged from the hospital for at least 14 days.
15748364|NCT04873401|Behavioral|Chain-referral|"In the chain-referral intervention, a discrete number of seeds will be recruited from the community partners, trained and incentivized to recruit and refer members of their social networks to receive COVID-19 testing. The peer recruiters are paid for each suvcessful and eligible recruit who enrolls to be tested. Those individuals are then themselves trained to recruit peers from their social networks to receive COVID-19 testing. This is repeated over a period of 4-6 months."
15748365|NCT04873401|Behavioral|Credible Messenger|In the credible messenger intervention, peers noted to be popular and socially influential individuals with lived experience will be trained to engage within community settings and areas to encourage community members to receive COVID-19 testing at the community partnering agencies. Peers will recruit community members over a period of 4-6 months.
15748366|NCT04873375|Drug|Cemiplimab|After inclusion patients will be treated with Cemiplimab 350mg intravenously every three weeks
15748367|NCT04873362|Drug|Atezolizumab|Atezolizumab will be administered at a dose of 1200 mg every three weeks (Q3W) for 14 cycles.
15748368|NCT04873362|Drug|Trastuzumab Emtansine|Trastuzumab emtansine will be administered at a dose of 3.6 mg/kg Q3W for 14 weeks.
15748369|NCT04873362|Drug|Placebo|Placebo matched to atezolizumab will be administered at a dose of 1200 mg Q3W for 14 cycles.
15748370|NCT04873362|Drug|Trastuzumab|Trastuzumab will be used to complete 14 cycles of study treatment if trastuzumab emtansine is discontinued for toxicity not considered to be related to the trastuzumab component of the drug.
15748371|NCT04873349|Dietary Supplement|Nusapure standardized olive leaves capsule, 750 mg (50% oleuropein)|two study groups; test group will receive Nusapure standardized olive leaves capsule, 750 mg (50% oleuropein) while placebo group will receive starch group
15748372|NCT04873336|Device|Intellivent ASV|A closed loop mechanical ventilation mode that adjusts oxygenization and ventilation automatically
15748373|NCT04873323|Drug|TS-142|Single dose of TS-142 10 mg or TS-142 30 mg in the morning under fasting in each period
15748374|NCT04873323|Drug|Moxifloxacin|Single dose of moxifloxacin 400 mg in the morning under fasting in each period
15748375|NCT04873323|Drug|Placebo|Single dose of TS-142 placebo in the morning under fasting in each period
15748376|NCT04873310|Other|Triple P online with professional support|The psychologist in charge will have the role of monitoring the autonomous work of the participants during the 8 sessions. The psychologist in charge will also verify that the participants are able to complete the online modules week by week, that they understand the contents taught in the module and that they are practicing the tasks and exercises assigned in each of the modules; in addition to generating an action plan in case the participants are not adhering week by week to the self-administration of the program. The follow-up and contact with the families will be carried out by phone and through a weekly email-type messaging system, implemented within the same platform on which the program material is found
15748377|NCT04873310|Other|Triple P online without professional support|The role of the psychologist in charge will be to keep the platform updated so that the person who self-administers the intervention does not have technical problems associated with the platform.
15748380|NCT04873284|Drug|fosaprepitant|"Granisetron+dexamethasone: granisetron:40mcg/kg, IV ; dexamethasone : S<0.6m2, 2 mg/dose, q12h IV/PO; S>0.6m2, 4 mg/dose, q12h , IV/PO. When used with fosaprepitant, dexamethasone dose was halved.
~Fosaprepitant: 4 mg/kg IV"
15748381|NCT04873284|Drug|aprepitant|"Granisetron+dexamethasone: granisetron:40mcg/kg, IV ; dexamethasone : S<0.6m2, 2 mg/dose, q12h IV/PO; S>0.6m2, 4 mg/dose, q12h , IV/PO. When used with aprepitant, dexamethasone dose was halved.
~Oral aprepitant: D1：Powder for suspension 3.0 mg/kg (up to 125 mg),D2，D3：Powder for suspension 2.0 mg/kg (up to 80 mg)."
15748382|NCT04873284|Drug|Granisetron plus dexamethasone|Granisetron+dexamethasone: granisetron:40mcg/kg, IV ; dexamethasone : S<0.6m2, 2 mg/dose, q12h IV/PO; S>0.6m2, 4 mg/dose, q12h , IV/PO.
15748383|NCT04873271|Device|Medtronic Implantable Tibial Neuromodulation (TNM) System|Tibial neuromodulation (TNM) devices are implantable devices that provide stimulation to the tibial nerve.
15748386|NCT04873232|Biological|Engensis|Injections with Engensis in study VMDN-003-2
15748387|NCT04873232|Other|Placebo|Injections with Placebo in study VMDN-003-2
15748389|NCT04873206|Other|routine stain by H&E.|formalin fixed, Parraffin embedded endometrial tissues will be sectioned and get stained by the routine Haematoxalin and Eosin stain in addition to immunohistochemical staining by anti-human PTEN antibody.
15748390|NCT04873193|Device|Leo device|Children's respiratory flow and volume measurements will be continuously recorded using the Leo device during oscillometry and pneumotach procedures.
15748391|NCT04873180|Diagnostic Test|sectioning and staining of renal neoplasms after nephrectomy operation|nephrectomy operations will be done to patients diagnosed as having renel tumors
15748392|NCT04873167|Behavioral|low fat|subjects subjected to a low-fat dietary regime
15748393|NCT04873167|Behavioral|mediterranean diet|subjects subjected to a mediterranean dietary regime
15748394|NCT04873141|Drug|Tocilizumab 200 Mg/10 mL (20 Mg/mL) INTRAVEN VIAL (ML)|Tocilizumab was given according to weight in patients with cytokinme releasew syndrome (CRS).
15748395|NCT04873128|Genetic|Multi-OMICS|Measurement of gene expression in immune cells (Human Peripheral Blood Mononuclear Cell (PBMCs) or total blood) using functional genomics, proteomics, metabolomics and lipidomics tools and compare the dynamics of immune response before and after vaccination against COVID-19.
15748396|NCT04873115|Other|Placebo|Sialanar placebo
15748397|NCT04873115|Drug|Sialanar|Sialanar - a licensed glycopyrronium bromide product
15748398|NCT04873115|Other|Oral Rehabilitation|Standard oral rehabilitation for provided drooling
15748399|NCT04873102|Drug|Danazol Pill|"Danazol is a synthetic steroid derived from ethisterone, It suppresses the pituitary-ovarian axis by inhibiting the pituitary output of gonadotropins. The pituitary-suppressive action of danazol is reversible. Danazol has been approved in treating endometriosis, fibrocystic breast disease, hereditary angioedema, thrombocytopenic purpura, and other conditions. It is metabolized and eliminated by renal and fecal pathways. The mean half-life of danazol in healthy males is 9.7 hours. After 6 months of 200 mg three times a day dosing in endometriosis patients, the half-life of danazol was reported as 23.7 hours.
~Adverse reactions from danazol include androgen like effects (i.e. weight gain, acne, mild hirsutism, edema, hair loss, voice change) and menstrual disturbances. The use of danazol in pregnancy is contraindicated. Other side effects include elevations in liver-enzyme levels and lipid abnormalities."
15748400|NCT04873089|Other|Cosmetic product|"It is a comparative study with two parallel groups of subjects:
~Tested group: twice daily application of the cream RV3278A cosmetic product on the whole face
~Comparative group: no application of study product or reference product"
15748401|NCT04873076|Device|Audiovisual distraction using 2d video glasses from HappyMed GmbH|Patients receive optical and acustical relaxing material during the procedure by using 2d video glasses from HappyMed GmbH
15748402|NCT04873063|Drug|Beclomethasone dipropionate|BDP 3 mg bid (R product) BDP 6 mg qd (T product)
15748403|NCT04873050|Drug|Semaglutide Pen Injector [Ozempic]|Start injection of semaglutide 0.25mg subcutaneously (SC) once a week for 4 weeks; step up to 0.5 mg SC QD for once a week for 4 weeks to a final dose of 1.0 mg semaglutide SQ weekly for 24 doses
15748404|NCT04873050|Drug|Placebo semaglutide pen injector|Start injection of placebo semaglutide 0.25mg subcutaneously (SC) one a week for 4 weeks; step up to 0.5 mg SC QD for once a week for 4 weeks to a final dose of 1.0 mg semaglutide SQ weekly for 24 doses
15748405|NCT04873037|Device|BTL Emsella Chair|The Emsella Chair is a novel high-intensity focused electromagnetic (HIFEM) technology for the treatment of pelvic floor related disorders. HIFEM technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercises over 28 minutes. The treatment paradigm consists of 3 different phases. The phases consist of an intense stimulation of the pelvic floor muscles (PFM), which consists of stimulation and relaxation. The repetition of the phases and focused electromagnetic energy delivery leads to pelvic floor stimulation, adaptation, and remodelation.
15748406|NCT04873037|Device|Sham BTL Emsella Chair|The sham treatment will provide some sensation without active HIFEM technology. The programming for the sham treatment will have an amplitude limitation, with the setting below therapeutic level (less than 10%) power.
15748407|NCT04873024|Device|cMAP Flow V 2.0|"Breathing data collected by the device will be processed by a machine learning algorithm to predict obstructive apnea events. When obstructive apnea events are predicted, the algorithm triggers the CPAP device to respond to the apnea event ahead of its onset.
~For the control treatment, the device will operate as its conventional treatment."
15748408|NCT04873011|Drug|Quinine Hydrochloride|After a stabilization period of 20 minutes and 10 minutes after the first blood collection, 10 mL of the quinine hydrochloride solution will be infused into the stomach in a randomized, double-blinded fashion
15748409|NCT04873011|Drug|Placebo|After a stabilization period of 20 minutes and 10 minutes after the first blood collection, 10 mL of water will be infused into the stomach in a randomized, double-blinded fashion
15748410|NCT04872998|Behavioral|Step Count Reduction|Subjects reduce daily step counts by approximately 70% through monitoring and recording from step-count monitor
15748411|NCT04872985|Drug|Pyrotinib|400 mg orally once per day
15748412|NCT04872985|Drug|Epirubicin|100 mg/m2,q3W*4
15748413|NCT04872985|Drug|Doxorubicin Hydrochloride Liposome Injection|30mg/m2, q3w*4
15748414|NCT04872985|Drug|Cyclophosphamide|600 mg/m2, q3w*4
15748415|NCT04872985|Drug|Docetaxel|100 mg/m2, q3w*4
15748416|NCT04872985|Drug|Nab paclitaxel|120mg/m2 qw*12
15748417|NCT04872985|Drug|Placebo|400 mg orally once per day
15748418|NCT04872972|Other|Simulation based learning|Faculty development courses on simulation based learning
15748419|NCT04872959|Other|HealthReveal|"In the Intervention arm, for each study visit, the site will receive a pre-visit assessment of GDMT accompanied by recommended adjustment(s) using information extracted weekly from the sites' EHR.
~The recommended adjustment(s) will be conveyed using proprietary software from HealthReveal, with a suggested follow up plan. All reminders regarding dosing targets are based on the 2020 ACC Expert Consensus Decision Pathway for Optimization of Heart Failure Treatment.
~Additionally, during visits at baseline, 3 months, and 6 months, the KCCQ-23 will be completed.
~In the Usual Care arm, during visits at baseline, 3 months, and 6 months, the KCCQ-23 will be completed."
15748420|NCT04872946|Dietary Supplement|Tea|Ashwagandha(Withania somnifera) root and leaf extract (32% Withania Oligosaccharides, 10% Withanolide Glycosides, 0.5% Withaferin A) 125 mg Saffron(Crocus Sativus) stigmas extract (3.48% Crocin and 0.03% Safranal) 28mg
15748452|NCT04872699|Diagnostic Test|Serology testing, RT PCR|Periodic testings and testings with characteristic symptoms occur
15748421|NCT04872946|Other|Serum|Aqua/Water/Eau, Glycerin, Propanediol, Diheptyl Succinate, Caprylic/Capric Triglyceride, Lactococcus Ferment Lysate, Sorbitol, Dimethicone, Steareth-21, Octyldodecyl Neopentanoate, Sodium Polyacrylate, Steareth-2, Caprylyl Glycol, Hydrogenated Polydecene, Trideceth-6, Octyldodecanol, Panthenol, Sodium PCA, Azelaic Acid, Bisabolol, Capryloyl Glycerin/Sebacic Acid Copolymer, Centella Asiatica Leaf Extract, Agastache Mexicana Flower/Leaf/Stem Extract, Caprylhydroxamic Acid, Phytic Acid, Aminomethyl Propanol, Lactic Acid, Sodium Chloride, Phenoxyethanol, Sodium Benzoate.
15748422|NCT04872946|Other|Moisturizer|Aqua/Water/Eau, Glycerin, Diisopropyl Dimer Dilinoleate, Coco-Caprylate, Lactococcus Ferment Lysate, Myristyl Myristate, Dimethicone, Propanediol, Behenyl Alcohol, Glyceryl Stearate SE, Potassium Cetyl Phosphate, Palmitic Acid, Ammonium Acryloyldimethyltaurate/Beheneth-25 Methacrylate Crosspolymer, Myristyl Laurate, Caprylyl Glycol, Hydroxyethylcellulose, Myristic Acid, Tocopherol, Ethylhexylglycerin, Centella Asiatica Leaf Extract, Agastache Mexicana Flower/Leaf/Stem Extract, Helianthus Annuus (Sunflower) Seed Oil, Trisodium Ethylenediamine Disuccinate, Lactic Acid, Sodium Hydroxide, Sodium Phosphate, Disodium Phosphate, Sodium Chloride, t-Butyl Alcohol, Phenoxyethanol, Sodium Benzoate.
15748423|NCT04872933|Other|Kidney Beam Online Platform|Kidney Beam is a wellbeing digital health intervention platform that offers patients living with kidney disease a way to improve their physical activity and boost their mental health through live and on demand movement classes and expert educational videos, while remaining in their own home. Kidney Beam is led by specialist kidney professionals, including renal physiotherapists and renal counsellors, from a number of different NHS Trusts and backgrounds, as well as people living with kidney disease.
15748424|NCT04872907|Device|adhesive system|adhesive system G-BOND. It will be applied to healthy temporary anterior and posterior teeth The adhesive system (on side defined by randomization) will be renew at 6, 12, 18 months, on all three sides due to the physiological wear of the temporary teeth (and therefore the wear of the material).
15748425|NCT04872907|Device|fluoride varnish|The reference drug is a fluoride varnish at 22,600 ppm of the brand Duraphat 50 mg / ml, dental suspension. The varnish is applied to healthy temporary anterior and posterior teeth, on the three sides of the teeth. The reference treatment (on side defined by randomization) will be renew at 6, 12, 18 months, on all three sides due to the physiological wear of the temporary teeth (and therefore the wear of the material).
15748426|NCT04872907|Drug|flowable composite|"Composite Essentia HiFlo. It will be applied on healthy temporary molar grooves (on side defined by randomization).
~Complete or partial renewal of the fluid composite in the grooves of the molars in the event of total or partial loss at 6, 12, 18 months"
15748427|NCT04872894|Other|Observational study. No intervention is performed|Descriptive study in participants with clinical and biochemical suspicion of FHH. Comparison between genotype-negative and genotype-positive participants with clinical and biochemical suspicion of FHH.
15748428|NCT04872881|Procedure|Endotracheal Tube Insertion|ETT will be repositioned with direct laryngoscopy (ETT cuff will be inflated just above the vocal cords)
15748429|NCT04872881|Procedure|Laryngeal Mask Insertion|After selecting the appropriate LMA size for the patient, the ET Tube will be removed and the LMA will be inserted.
15748430|NCT04872881|Procedure|Fiberoptic Bronchoscopy|"After the patients' airway is established, the trachea and the process area will be displayed by the physician.
~The success rate will be increased by performing the procedure with fiberoptic bronchoscopy."
15748431|NCT04872881|Procedure|Radial Artery Monitoring|The radial artery will be cannulated. Hemodynamic monitoring and blood gas analysis will be done in this way.
15748432|NCT04872881|Diagnostic Test|Anteroposterior chest x-ray|When the tracheostomy cannula is placed and the patient is ventilated, the procedure will be terminated and confirmed with anteroposterior chest x-ray.
15748433|NCT04872881|Diagnostic Test|Arterial Blood Gas Analyses|Hypoxia, acidosis and carbon dioxide increase will be followed
15748434|NCT04872881|Drug|Propofol Fresenius|2mg/kg of propofol 2% injectable solution was given and propofol infusion at the dose of 6 mg/kg/hour will be started.
15748435|NCT04872881|Drug|Rocuronium|0.6 mg/kg of rocuronium 50mg/5ml injectable solution was given.
15748436|NCT04872881|Drug|Fentanyl|1mcg/kg fentanyl of 0.5 mg/10ml injectable solution was given.
15748437|NCT04872855|Device|patient with knee arthroplasty|patient with HLS KneeTec cementless and hybrid fixation prosthesis
15748438|NCT04872842|Other|Obervation|This study is an observational study without any intervention
15748439|NCT04872829|Device|cataract surgery|"All patients underwent cataract surgery under 1 year of age (mean age 8 months, range 6-12) performed with the same surgical technique: two 1.2 mm clear corneal incision, continuous curvilinear capsulorhexis with a diameter of approximately 6.0 mm and intraocular lens implantation, posterior capsulotomy and anterior vitrectomy.
~IOL power was calculated using Sanders-Retzlaff-Kraff (SRK)/II formula. Multifocal IOL implantated was Alcon AcrySof ReSTOR SN60D3, while the monofocal one was Alcon AcrySof SN60AT.
~According to the Infant Aphakia treatment Study, the IOL power was calculated as a function of the child age17, with an undercorrection ranging from 4 to 6 D."
15748440|NCT04872816|Device|Continuous airway positive pressure|The continuous airway positive pressure will be used as the gold-standard treatment for obstructive sleep apnea for 6 months
15748441|NCT04872790|Drug|Dasatinib|Given PO
15748442|NCT04872790|Drug|Methotrexate|Given IT
15748443|NCT04872790|Drug|Prednisone|Given PO
15748444|NCT04872790|Biological|Rituximab|Given IV
15748445|NCT04872790|Drug|Venetoclax|Given PO
15748446|NCT04872777|Behavioral|Noom Healthy Weight|"Following study group assignment, the following procedures will be completed for the Noom HW mHealth lifestyle intervention:
~Noom application set-up and troubleshooting on smartphone (license provided)
~Digital scale provision (subjects may keep the scale)
~Capture of available clinical information over preceding 28-days."
15748447|NCT04872764|Other|duration of hospitalization, mortality rate|duration of hospitalization, mortality rates of patients hospitalised for COVID-19 evaluated and compared in patients with and without acute kidney injury.
15748448|NCT04872738|Other|Survey|Patients in all groups will complete surveys about their decision to receive or not to receive the COVID-19 vaccine. For those who did receive the vaccine, they will indicate their experience with the vaccination and any side effects they may have experienced.
15748449|NCT04872725|Behavioral|Time management & participation & the leisure time activity|evaluated in terms of leisure time activities, time management and participation
15748450|NCT04872712|Procedure|Press needles|Manual acupuncture using press needles
15748453|NCT04872686|Drug|0.6% PVP-I oral and nasal spray to moderately ill COVID-19 positive patient|"Number of participants 768 COVID-19 positive, moderately ill admitted patient who will receive intervention
~Step 1: Enrollment of the study populations by applying inclusion and exclusion criteria Step 2: Randomization to allocate experimental and controlled group by using table of random number Step 3: Application of 0.6% PVP-I spray to experimental group and distilled water to control group Step 4: Follow up (waiting for 2-5 minutes) Step 5: Collection of nasopharyngeal and oropharyngealsawab for RT-PCR test for both group Step 6: Observation of the patients for 30 minutes for possible early adverse effects (if any) and subsequent management (if needed).
~Step 7: Analysis data collection, data processing and analysis by using SPSS software."
15748454|NCT04872686|Drug|0.6% PVP-I Oral and nasal spray to asymptomatic to mild COVID-19 patient having multiple comorbidity|"Number of participants 20 asymptomatic to mild COVID -19 patients having multiple comorbidity who will receive intervention
~Step 1: Selection of 20 patients randomly with no or mild symptoms and obtain their consent for the further tests.
~Step 2: Collection of 2nd, 3rd and 4th sample from nasopharynx and oropharynx hourly Step 3: Data collection, data processing and analysis by using SPSS software"
15748455|NCT04872686|Drug|0.6% PVP-I Oral and nasal spray to healthy volunteer|"Number of participants 10 healthy individual who accept intervention 0.6% PVP-I oronasal spray
~Step 1: Selection of 10 healthy volunteers randomly who will be selected for using 0.6% PVP-I Oro-Nasal spray 2 puff inside both nostrils and mouth 3 to 4 times a day for one month.
~Step 2: Collection of blood & urine of participants on day 0, 10, 20, 30 for determination of any change in biochemical marker (thyroid, kidney and liver functions will be done) Step 3: Data collection, data processing and analysis by using SPSS software"
15748456|NCT04872686|Other|Oral and nasal spray by distilled water to control group|Placebo comparator: Distilled Water Oral and Nasal spray will be provided by Distilled water to control group
15748457|NCT04872660|Drug|Gushen Antai Pill|The Gushen Antai Pill (GSATP, Z20030144) is composed of 10 herbs including radix-polygoni multiflori, radix rehmanniae praeparata, cistanche salsa, radix dipsaci, uncaria, semen cuscutae, rhizoma atractylodis macrocephalae, radix scutellariae, radix paeoniae lactiflorae. Its production follows GMP standards and takes the form of water honey pills, each bag of 6g.
15748458|NCT04872660|Drug|Placebo pill|The placebo pill is produced by Beijing boran Pharmaceutical Co., Ltd. It can simulate the appearance, color and smell of GSATP formula, but it has no clinical effect because it has no active ingredients.
15748459|NCT04872647|Behavioral|Phone-Based Health Coaching Utilizing Lifestyle Action Plans|Culturally sensitive health coaches trained in motivational interviewing provide 10-20 minutes of weekly phone-based health coaching. They not only guide the patient in creating a SMART goal, but assess and build off of the previous weeks' goal and problem-solve with the patient. During the week, the coach and patient text regarding daily blood glucose monitoring with real-time feedback and coaching about the implementation of the patients' goal.
15748460|NCT04872634|Biological|SNK01 (Super Natural Killer Cells 01)|Investigational Product : SNK01 (Super Natural Killer Cells 01) Principal Component : Autologous Natural Killer Cell To induce anti-tumor immunity in Locally advanced or Metastatic Non-small Cell Lung Cancer Patients who have failed prior TKI therapy for EGFR, ALK, or ROS1 Gene Mutation and to strengthen the Antibody-Dependent Cellular Cytotoxicity (ADCC) of Cetuximab, 4x10^9 or 6x10^9 cells are infused through the veins of the subjects within 45 minutes (±15 minutes) per 100 mL total 8 times at intervals of one week.
15748461|NCT04872634|Drug|GC|"Gemcitabine; 1000mg/m2, Day 1, Day 8, 4-cycle administration, Mixed with normal saline 50ml and administered into a vein for 30 min.
~Carboplatin; AUC 5, Day 1, 4-cycle administration, Mixed with 5% Dextrose 200ml and administered into a vein for 1 hour."
15748462|NCT04872634|Biological|Cetuximab|"First administration: 400mg/m2 Subsequent administration: 250mg/m2 (Premedication before administration*) Weekly Administration continues until the disease progresses or unacceptable toxicity develops.
~400mg/m2: Administered into a vein for 120 minutes 250mg/m2: Administered into a vein for 60 minutes"
15748463|NCT04872608|Drug|Letrozole|Letrozole will be given daily on days 1-28.
15748464|NCT04872608|Drug|Palbociclib|Palbociclib will be given daily on days 1-21 and held on days 22-28, as per standard FDA-approved dosing guidelines.
15748465|NCT04872608|Drug|Onapristone ER|Onapristone will be given daily on days 1-28.
15748466|NCT04872595|Other|Personalized rATG (P-rATG)|P-rATG days (always starting on Day -12 to -10)
15748467|NCT04872595|Radiation|Hyper fractionated total body irradiation|"(1375 - 1500cGy*) Day -9 to -6
~*TBI dose in 125cGy fractions (with lung shielding) and total dose to be determined by treating physician/radiation oncology and is based off age, stage of disease, and anesthesia requirements."
15748468|NCT04872595|Drug|Thiotepa|(5mg/kg/day x 2 day) Day -5 to -4
15748469|NCT04872595|Drug|Cyclophosphamide|(60mg/kg/day x 2 days) Day -3 to -2
15748470|NCT04872595|Drug|GCSF|Day +7
15748471|NCT04872595|Drug|Busulfan|Day -9 to -7 doses 2-3 to be adjusted per PK for target cumulative exposure of 65 mg*h/L
15748472|NCT04872595|Drug|Melphalan|(70mg/m2/day x 2 days) Day -6 to -5
15748473|NCT04872595|Drug|Fludarabine|(25mg/m2/day x 5 days) Day -6 to -2
15748474|NCT04872582|Drug|PD-1 Immune Checkpoint Inhibitor Combined With Bevacizumab|combined
15748475|NCT04872569|Behavioral|Decision-making tool|"Participants will be directed to use the decision tool for 3 months using it at their own pace.
~The tool covers topics relevant to women with disabilities in considering or planning a pregnancy and reflects core elements of decision making tools based on the Ottawa Framework for Decision Support."
15748476|NCT04872556|Device|Laser acupuncture device|The experiment group would arrange laser acupuncture on day1 and day3 after Taxanes treatment. In the mean while, blood tests were performed with the C-Reactive protein, erythrocyte sedimentation rate, Interleukin-6 for each participants. Evaluation would be records on day1, day3, and day 8 after Taxanes treatment.
15748477|NCT04872556|Device|Pseudo-laser acupuncture|The experiment group would arrange Pseudo-laser acupuncture on day1 and day3 after Taxanes treatment. In the mean while, blood tests were performed with the C-Reactive protein, erythrocyte sedimentation rate, Interleukin-6 for each participants. Evaluation would be records on day1, day3, and day 8 after Taxanes treatment.
15748478|NCT04872543|Drug|ASTX727|ASTX727 will be self-administered orally by the patient on a once daily basis, days 1 through 5 of each 28-day cycle. Cycle 1 day 1 (C1D1) is defined as the first day that ASTX727 is administered.
15748479|NCT04872530|Dietary Supplement|Pea-protein concentrate|Pea-protein concentrate
15748485|NCT04872517|Device|Meridian Electroacupuncture Analysis Device (MEAD)|use MEAD to detect energy change in patient with head and neck cancer
15748486|NCT04872504|Device|Acumen HPI-enabled EV1000 screen|Acumen HPI-enabled EV1000 screen record the incidence of intraoperative hypotension
15748487|NCT04872478|Drug|MRX-2843|MRX-2843 capsules
15748488|NCT04872465|Device|TBS|We initially used cTBS (continuous TBS) over right DLPFC with 120-s train of uninterrupted bursts (1800 pulses) in each session per day. After that, we continuous use iTBS (intermittent TBS, iTBS) over left DLPFC with 2-s train of bursts was repeated every 10 s for a total of 570 s (1800 pulses).
15748489|NCT04872465|Device|sham|Participants will receive sham (placebo) TBS treatment the same as experimental group
15748490|NCT04872452|Procedure|Skin biopsy|Any combination of the following six 3-6mm skin biopsies may be taken: palm, dorsum of hand, calf, other non-genital and non-face (this last one includes areas for use as negative controls which are not on the distal limbs). No more than 6 biopsies will be taken at one time.The biopsy size 3-6mm and method (punch, shave or wedge) will be done depending on the biologic assay destined for the biopsy. While 3mm will be sufficient for microarray analysis, 6mm will be required for any cell sorting preceding microarray analysis.
15748491|NCT04872439|Diagnostic Test|Blood sample collection|Patients with autoimmune gastrointestinal dysmotility will provide 20 mL of blood to isolate serum, plasma and peripheral blood mononuclear cells for whole exome sequence. Antibodies to be isolated are: Antineuronal nuclear antibody type 1,Collapsing response-mediator family immunoglobulin G, Ganglionic Acetylcholine Receptor Antibody, Muscle Acetylcholine Receptor Antibody, Striational, Voltage-gated calcium channel, N- type, Voltage-gated calcium channel, P/Q- type, Voltage-gated potassium channel, Glutamic Acid Decarboxylase 65, Gastric parietal cell, Thyroperoxidase, Thyroglobulin
15748492|NCT04872426|Other|Exercise, insulin infusion|Acute one-legged exercise, Insulin infusion 3 hours after one-legged exercise
15748493|NCT04872413|Procedure|Biospecimen Collection|Undergo blood, saliva or tissue sample collection
15748494|NCT04872413|Other|Follow-Up|Undergo follow-up
15748495|NCT04872400|Drug|Vancomycin|1 vial of Vancomycin 1g powder applied topically to the open fracture wound injury.
15748496|NCT04872400|Drug|Tobramycin|1 vial of Tobramycin 1.2g powder applied topically to the open fracture wound injury.
15748497|NCT04872387|Drug|BAY2586116|Nasal administration
15748498|NCT04872387|Drug|Placebo|Matching placebo
15748499|NCT04872374|Dietary Supplement|Parmigiano Reggiano|subjects will receive 50 g/die of the dietary supplement 10 days before performing the eccentric exercise session
15748500|NCT04872374|Dietary Supplement|Whey Protein|subjects will receive 20 g/die of the dietary supplement 10 days before performing the eccentric exercise session
15748501|NCT04872361|Procedure|Low PEEP|Patients will be ventilated with a PEEP of 4 cm H2O and no RMs throughout the study
15748502|NCT04872361|Procedure|High PEEP|PEEP of 10 cm H2O will be applied
15748503|NCT04872361|Procedure|High PEEP/RM|PEEP of 10 cm H2O and RM (30 cm H2O for 30 s) immediately after the second lung ultrasonographic examination and repeated every 30 minutes till emergence
15748504|NCT04872361|Device|Lung ultrasonogrphy assessment|"The thorax will divided into 12 quadrants, each of them will be assigned a score of 0-3 as 0, normal lung sliding with fewer than three single B lines
~three or more B lines
~coalescent B lines
~consolidated lung. The LUS (0-36) will be calculated with higher scores indicating more aeration loss"
15748505|NCT04872348|Device|OMNI® Surgical System|The OMNI® Surgical System is indicated for canaloplasty (microcatheterization and transluminal viscodilation of Schlemm's canal) followed by trabeculotomy (cutting of trabecular meshwork) to reduce intraocular pressure in adult patients with primary open-angle glaucoma.
15748506|NCT04872335|Other|Gong's Mobilization|Group A received Gong's mobilization and common treatnent (TENs,Hot pack and cervical stretches). Gong's mobilization which is concurrent application of Apophyseal joint gliding and end range passive physiological movements while the subject's cervical postures are passively Neutral in order to induce Normal Cervical Extension. The Subjects in Group A were treated three times in a week for 4 weeks.
15748507|NCT04872335|Other|Gradually Graded Exercise Therapy|"The Subjects in Group B were received Exercise Therapy and common treatment (TENs, Hot pack and cervical stretches) three times in a week continue for 4 weeks . Each exercise session will take 30 min. It will be consisted of 5 min warm-up exercises, 20 min stabilization exercises, 5 min cool-down, and stretching exercises including neck and shoulder girdle muscles.
~The aim of Exercise program was to create a neutral spine and activate deep muscles of the cervical spine. The patients were educated to maintain neutral spine during the exercises and throughout the day as much as possible.
~Scapulothoracic stabilization exercises were included_ specific exercises for the muscles affecting scapular orientation related to neck pain. The subjects were educated to maintain the positions and contractions during the exercises including scapular retraction, eccentric scapular retraction, and combined scapular retraction with shoulder lateral rotation, forward punch, and dynamic hug."
15748508|NCT04872322|Drug|Ropivacaine 0.5% Injectable Solution|Participants will receive the nerve block preoperatively using 0.5% ropivacaine
15748509|NCT04872322|Drug|Ropivacaine 0.25% Injectable Solution|Participants will receive the nerve block preoperatively using 0.25% ropivacaine
15748510|NCT04872322|Drug|Percocet Pill|After surgery participants will be given a prescription for Percocet to be taken as needed for pain
15748511|NCT04872322|Drug|Norco Pill|After surgery participants will be given a prescription for Norco to be taken as needed for pain
15748512|NCT04872322|Procedure|Foot/Ankle Surgery|Participant will undergo foot or ankle surgery and receive a popliteal nerve block
15748513|NCT04872296|Device|Controlled Ankle Motion (CAM) boot|A CAM boot will be worn on the affected ankle to allow weight bearing
15748514|NCT04872296|Procedure|Physical Therapy|Standard physical therapy protocol will be started at 6 weeks after surgery
15748515|NCT04872283|Procedure|great toe (1st metatarsophalangeal joint) fusion|Great Toe joint fusion surgery
15748516|NCT04872283|Drug|IV Ketorolac|Participants will receive 30mg of intravenous (IV) ketorolac will be given during surgery
15748517|NCT04872283|Drug|Ketorolac Pill|Participants will receive 20 tablets of 10mg ketorolac, with instructions to take 1 tablet orally every 6 hours for pain
15748518|NCT04872283|Drug|5/325mg Oxycodone-Acetaminophen|Participants will receive 30 tablets of 5/325mg oxycodone-acetaminophen with instructions to take 1 or 2 tablets by mouth every 4 to 6 hours as needed for pain
15748519|NCT04872283|Drug|Aspirin 81Mg Ec Tab|Participants will receive 81 mg aspirin twice daily as a preventive measure against deep venous thrombosis (DVT)
15748520|NCT04872270|Procedure|Total Shoulder Arthroplasty|Participant will have total shoulder replacement
15748521|NCT04872270|Drug|Caffeine Pill|2 week supply of 1000 mg caffeine given postoperatively as part of the pain regimen
15748522|NCT04872270|Drug|Percocet 10Mg-325Mg Tablet|given postoperatively as standard post-op pain management
15748523|NCT04872270|Drug|Zofran 4Mg Tablet|given postoperatively as standard post-op management
15748524|NCT04872257|Drug|Oral Vitamin D|Vitamin D 5,000 UI for 6 months (oral capsule, daily, single-dose)
15748525|NCT04872257|Procedure|NB-UVB Phototherapy|NB-UVB Phototherapy twice per week for 6 months until completing 48 sessions. Initial dose of 200 mJ/cm² with a 10-20% increase to the previous session. Maximum dose for face and neck is 1500 mJ/cm² and 3000 mJ/cm² for the rest of the body.
15748526|NCT04872257|Drug|Placebo|Administered orally daily for 6 months
15748527|NCT04872244|Device|usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele|usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele for postmenstrual spotting and do not have desire for fertility
15748528|NCT04872244|Drug|Levonorgestrel Drug Implant Product|intrauterine administration
15748529|NCT04872231|Drug|Voriconazole Inhalation Powder|"PART A (SAD): Voriconazole Inhalation Powder (VIP) will be supplied as one to eight 10 mg capsules. Each capsule contains 10 mg of VIP and will be administered with a Plastiape RS00 Dry Powder inhaler. Doses may require multiple inhalations. All inhalations must be conducted within a 10-minute period.
~SAD subjects will receive a single dose of study medication. Subjects in Cohort 1 will receive 10 mg, Cohort 2: 20 mg, Cohort 3: 40 mg, Cohort 4: 80 mg.
~PART B (MAD): Voriconazole Inhalation Powder (VIP) and will be administered with a will be supplied as one to eight 10 mg capsules. Each capsule contains 10 mg of VIP and will be administered with a Plastiape RS00 Dry Powder inhaler. Doses may require multiple inhalations. All inhalations must be conducted within a 10-minute period.
~MAD subjects will receive VIP BID for a total of 13 doses. Subjects in Cohort 1 will receive 10 mg BID, Cohort 2: 20 mg BID, Cohort 3: 40 mg BID, Cohort 4: 80 mg BID."
15748530|NCT04872231|Drug|Placebo|"PART A (SAD): Placebo capsules will be supplied as one to eight capsules. Each capsule contains placebo inhalation powder. The capsules will be matched for use within the provided Plastiape RS00 Dry Powder inhaler device (Model 8). Doses may require multiple inhalations through the inhaler device. All inhalations must be conducted within a maximum of 10-minute period.
~Subjects in PART A will receive a single dose of placebo.
~PART B (MAD): Placebo will be supplied as one to eight capsules. Each capsule contains placebo inhalation powder. The capsules will be matched for use within the provided Plastiape RS00 Dry Powder inhaler device (Model 8). Doses may require multiple inhalations through the inhaler device. All inhalations must be conducted within a maximum of 10-minute period.
~Subjects in PART B will receive Placebo BID for a total of 13 doses."
15748531|NCT04872218|Drug|Abatacept|24 week treatment of IV abatacept following recommended dosages from the monograph
15748532|NCT04872218|Drug|Placebo|24 week treatment of IV placebo following recommended dosages from the abatacept monograph
15748533|NCT04872218|Other|Peanut oral immunotherapy|Peanut oral immunotherapy, following a patient-driven protocol, starting 24 to 72h after the first administration of abatacept or placebo.
15748534|NCT04872192|Other|transversus thoracic muscle plane block|transversus thoracic muscle plane block by injection of 15 ml of bupivacaine 0.25% on each side combined with general anaesthesia
15748535|NCT04872192|Other|general anaesthesia|transversus thoracic muscle plane block by injection of 15 ml of saline on each side combined with general anaesthesia
15748536|NCT04872166|Drug|BTX-A51|One 28 day cycle of treatment will consist of 4 weeks of treatment with a weekly dosing schedule of 5 days on/2 days off.
15748537|NCT04872153|Behavioral|Dividat Senso Exergames|"The intervention period in the rehabilitation setting will be equal to the length of the stay in the rehabilitation clinic (between 2-3 weeks, according to each cantonal/regional regulations and insurance coverage) and will include short daily training sessions using the Senso (5x/week à 10- 15min), resulting in 15 to 20 training sessions in total.
~Each session contains various combinations of the Dividat exergames (each of the games lasts around 2-3min)."
15748541|NCT04872127|Device|proximal embolism protection device|a proximal occlusion Mo.Ma will be used as the embolism protection device during CAS
15748542|NCT04872127|Device|distal embolism protection device|a distal SpiderFX will be used as the embolism protection device during CAS
15748543|NCT04872114|Device|SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator|Radiofrequency ablation of renal arterial sympathetic nerves
15748546|NCT04872088|Behavioral|Strengthened SBCC|Social and Behavioral Change Communication related to prenatal, postnatal, IYCF practices as well as on the care of young children at several specific ages, hygiene, and health will be delivered during monthly home visits by pairs of NASG members.
15748547|NCT04872088|Dietary Supplement|Preventive nutritional supplement|"Monthly delivery by NAGS pairs of a nutritional supplement: SQ-LNS, at a dose of 28 bags of 20g per month per beneficiary child. The nutritional supplement is limited to :
~- [6-17]months old children diagnosed as non-wasted (MUAC>=125mm)"
15748548|NCT04872088|Behavioral|Family MUAC|"MUAC screening of children 6 to 59 months of age by family members will be introduced. This will involve distributing Shakir MUAC tapes to all intervention households and training mothers/guardians, or any other family member expressing an interest, in the screening of wasting with the MUAC criterion.
~The training will be carried out by the members of the NASGs and during each home visit, they will be able to ensure that the MUAC measurement technique is well mastered by the mother (or another member) and correct the technique if necessary. They will also explain the procedure to be followed if the child is diagnosed as wasted by a family."
15748549|NCT04872088|Behavioral|Active screening by NASGs|"Monthly screening by the NASG members of the children they follow, using the MUAC.
~Referral to the health center of [6-17] months old children screened as malnourished (result of MUAC orange or red), and follow-up on referral to confirm child was enrolled."
15748550|NCT04872088|Behavioral|Intensified followup of children with wasting referred to and enrolled in CMAM treatment|NASG members will conduct biweekly follow-up visits in the households of children with wasting referred to and enrolled in CMAM treatment programs to ensure adherence to the outpatient treatment schedule.
15748551|NCT04872088|Behavioral|Relapse prevention|NASG members will conduct biweekly home visits to monitor the nutritional status of children aged 9 to 17 months who were discharged from CMAM treatment after recovery. NASGs members will provide additional counseling to prevent relapse and screen these children for wasting to detect possible relapse.
15748552|NCT04872088|Behavioral|Cooking demonstrations|NASGs members will also be supported by the IRAM project in the organization of cooking demonstrations with nutrient-rich foods in the community, during which passive screening of children will be carried out.
15748553|NCT04872075|Other|Concert|People attending a concert in a closed area, with a mask
15748554|NCT04872075|Diagnostic Test|Rapid nasopharyngeal antigen test for Sars-Cov-2|A nasopharyngeal swab at inclusion (up to 3 days before concert) to confirm eligibility
15748555|NCT04872075|Diagnostic Test|Saliva Sample|Saliva samples sent by participant at Day0 and Day7
15748556|NCT04872062|Device|NIV cards|Reading the data available on the NIV cards
15748557|NCT04872062|Other|Medical file|Using the data available in the medical file including clinical data, blood gas results, nocturnal oximetry results
15748558|NCT04872023|Other|Blood and bone marrow sampling|Blood and bone marrow sampling
15748559|NCT04871984|Device|Ureteroscopy for upper tract stone treatment with Holmium laser|Rigid or flexible ureteroscopy for ureteral or renal stone. Lithotripsy with Holmium laser
15748560|NCT04871984|Device|Ureteroscopy for upper tract stone treatment with Thulium laser|Rigid or flexible ureteroscopy for ureteral or renal stone. Lithotripsy with Thulium laser
15748566|NCT04871958|Device|Continuous glucose monitoring (CGM, Dexcom G6)|"The Dexcom G6 sensor will be placed on the back of the upper arm at admission and changed after 10 days. In the participants randomized to Real-time CGM, glucose values will be transmitted through Bluetooth to a mobile phone at the bedside. From this phone data are transmitted to a tablet in the nursing station.
~In the blinded CGM group, sensor readings will be blinded to patient and healthcare providers.
~The MDI groups will be managed with basal/bolus insulin regimen, as clinically indicated.
~V-Go will be placed on the abdomen each morning. Insulin-naïve patients randomized to the V-Go system will start at the lowest basal rate (20 UI/24h).
~On daily basis, expert diabetologists will retrospectively review CGM data and provide indications for insulin therapy adjustments."
15748567|NCT04871945|Diagnostic Test|Elecsys Anti-SARS-CoV-2 S (Roche Diagnostics GmbH, Mannheim, Germany), 2) ACCESS SARS-CoV-2 IgG II (Beckman Coulter, Inc. USA)|The antibody level will be measured by the above mentioned methods. The trial drugs are not used but the vaccine that included in National Immunization Program for COVID-19 in Korea will be used for the study.
15748568|NCT04871932|Biological|Recently Vaccination|
15748569|NCT04871919|Drug|Filgotinib|Tablets are administered in accordance with the product label
15748570|NCT04871906|Other|stretching exercises|Our interventions are home-based stretching exercises. The experimental group will receive 6 stretching exercises which stretch 20-30 seconds, relax for 10 seconds, and repeat 5 times for each side. It will take 25-30 minutes every day for continuous 8 weeks. Those include stretching of the deep front line, spiral line, superficial front line, lateral line, superficial back line, and plantar flexors. Designed concepts are the following three: 1) based on ''Anatomy- Train'' theory, 2) emphasize on movements of trunk and pelvis, and 3) stress on the stretching of lower extremities.
15748571|NCT04871893|Device|multiECCO2R blood-gas exchanger|Treatment with the blood-gas exchanger multiECCO2R for CO2 removal
15748572|NCT04871880|Behavioral|Dietitian led life style modification intervention|All participants received recommendations for a low-fat hypocaloric diet that was 750 kcal/day less than their daily energy need which supervised by dietitians. Additionally, patients were encouraged to walk 200 minutes per weeks and a short self-report questionnaire for the measurement of habitual physical activity was implemented at baseline, 4, 16, 32 and 48 weeks.
15748573|NCT04871880|Behavioral|Conventional care (control)|Receive routine care
15748574|NCT04871854|Drug|Tocilizumab|patients treated with Tocilizumab for Covid-19 infection
15748575|NCT04871841|Biological|Sputnik V|Participants will receive intramuscular (IM) injection of a single dose of rAd26-S and rAd5-S at day 0 and day 21, respectively.
15748576|NCT04871828|Drug|Leukotriene Receptor Antagonist|Zafirlukast
15748577|NCT04871828|Other|Placebo|Placebo
15748578|NCT04871815|Drug|sodium pyruvate nasal spray|Subjects will use a sodium pyruvate nasal spray 3x daily for 7 days.
15748579|NCT04871802|Dietary Supplement|Taxifolin Aqua|Dietary supplement
15748580|NCT04871789|Diagnostic Test|Laboratory and instrumental examination|All patients will undergo a comprehensive examination to identify the consequences of COVID-19
15748581|NCT04871776|Behavioral|Messaging informed by construal level theory|"Messages are informed by construal level theory, which suggests that emphasizing why elicits more abstract thinking, or high-level construals, and can induce an emotional mindset, which could challenge an individual's sense of identity, autonomy, or political preferences. Conversely, emphasizing how is more cognitive and evokes concrete thinking, or low-level construals, and encourages a planning or implementation mindset, which may be better for encouraging vaccine uptake."
15748586|NCT04871750|Dietary Supplement|Soy protein|Daily consumption for 24 weeks
15748587|NCT04871750|Dietary Supplement|Casein protein|Daily consumption for 24 weeks
15748588|NCT04871737|Biological|Recombinant NDV Vectored Vaccine for SARS-CoV-2|Recombinant Newcastle Disease Virus Vectored Vaccine for SARS-CoV-2
15748589|NCT04871724|Drug|EDP-938|Subjects will receive EDP-938 once daily on Days 1 and 14
15748590|NCT04871724|Drug|Fluconazole|Subjects will receive fluconazole once daily on Days 5 to 18
15748593|NCT04871685|Diagnostic Test|lung ultrasound|the patients underwent to a non invasive diagnostic exam to identify and monitor clinical conditions and onset of respiratory complications due to COVID-19
15748594|NCT04871672|Other|Pilates Exercises|basic five pilates intermediate workout based on the principles of Pilates
15748595|NCT04871672|Other|Home Exercise program|home exercise
15748596|NCT04871659|Other|Online Survey completion|Eligible participants will complete surveys electronically via Amazon's mTurk platform
15748597|NCT04871646|Drug|CKD-314+SOC|CKD-314 is administered intravenously and standard of care is also performed.
15748598|NCT04871646|Drug|CKD-314 Placebo+SOC|CKD-314 placebo is administered intravenously and standard of care is also performed..
15748599|NCT04871633|Drug|Remdesivir|Remdesivir is an intravenous (IV) loading dose of 200 mg on day 1 followed by daily IV maintenance doses of 100 mg for 5-10 days
15748600|NCT04871633|Drug|Conventional|IV Steroids Antibiotics
15748601|NCT04871620|Diagnostic Test|>15% SV increase during fluid challenge|The stroke volume will be measured before and after 15 minutes fluid challenge with crystalloids
15748608|NCT04871594|Drug|Domatinostat|Cohort A1: day 1-56 200mg BID Cohort B1: day 1-56 200mg QD
15748609|NCT04871594|Drug|Nivolumab|Cohort A1: day 1, 22, and 43 240mg Cohort A2: day 1, 22, and 43 240mg Cohort B1: day 22 80mg, day 43 240mg Cohort B2: day 22 80mg, day 43 240mg
15748610|NCT04871594|Drug|Ipilimumab|Cohort B1: day 1 240mg, day 22 240mg Cohort B2: day 1 240mg, day 22 240mg
15748611|NCT04871581|Device|NTI-tss|FDA cleared device for prophylactic treatment of medically diagnosed migraine pain
15748612|NCT04871581|Device|Placebo|Similar to Device, but having no influence on clenching intensity
15748613|NCT04871568|Procedure|Temporary central dialysis catheterization|Placement of temporary central dialysis catheter
15748614|NCT04871555|Other|MRI|structural imaging
15748615|NCT04871542|Procedure|Biospecimen Collection|Undergo collection of blood sample
15748616|NCT04871542|Other|Questionnaire Administration|Complete questionnaires
15748617|NCT04871529|Procedure|Therapeutic Conventional Surgery|Undergo surgery
15748618|NCT04871529|Drug|Avelumab|Given IV
15748619|NCT04871529|Drug|Gemcitabine Hydrochloride|Given IV
15748620|NCT04871529|Drug|Carboplatin|Given IV
15748621|NCT04871516|Other|Quality-of-Life Assessment|Ancillary studies
15748622|NCT04871516|Other|Questionnaire Administration|Ancillary studies
15748623|NCT04871516|Radiation|Radiation Boost|Undergo radiation therapy boost
15748624|NCT04871516|Procedure|Therapeutic Surgical Procedure|Undergo standard surgery
15748625|NCT04871516|Radiation|Whole Breast Irradiation|Undergo standard WBI
15748626|NCT04871516|Other|Breast MRI|A baseline breast MRI
15748627|NCT04871503|Device|BTL-899 Buttocks|The treatment administration phase in both study groups will consist of four (4) treatments, delivered 5-10 days apart. The applicators of BTL-899 will be applied over the gluteal area.
15748628|NCT04871490|Diagnostic Test|Blood test for HPV DNA|All participants will have blood tested for HPV DNA.
15748629|NCT04871477|Other|Communication Intervention|Audio record part of clinic visit
15748630|NCT04871477|Other|Questionnaire Administration|Ancillary studies
15748631|NCT04871464|Drug|Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules|Oral
15748632|NCT04871464|Other|Placebo|Oral
15748633|NCT04871451|Drug|ABP-450|ABP-450 (prabotulinumtoxinA) contains a 900kDA botulinum toxin type-A complex produced by the bacterium Clostridium botulinum.
15748634|NCT04871438|Device|Flash glucose monitoring|Group A will use FreeStyle Libre for two weeks of FGM-based titration of medications at two time-points: 1) At recruitment and 2) At 6 weeks. Outside of these time points, they will use SMBG (standard care) for monitoring of blood glucose.
15748635|NCT04871425|Drug|Ketamine|IV ketamine
15748636|NCT04871425|Drug|Fentanyl|IV fentanyl
15748637|NCT04871412|Dietary Supplement|Vitamin D3 Drops|1,000 - 10,000 units daily based on serum levels for the duration of the study
15748638|NCT04871412|Dietary Supplement|Coriolus Versicolor|1.5g twice daily for the duration of the study
15748639|NCT04871412|Dietary Supplement|Trident SAP 66:33 Lemon|3g once daily for the duration of the study
15748640|NCT04871412|Dietary Supplement|Probiotic Pro12|12 billion colony forming units daily during the peri-operative period (approximately 1 month pre and post-surgery)
15748641|NCT04871412|Dietary Supplement|Provitalix Pure Whey Protein|1 scoop (22g) once daily during the peri-operative period (approximately 1 month pre and post-surgery) and during any adjuvant chemotherapy and radiation treatments
15748671|NCT04871204|Drug|Octreotide Injection|10 mg Sandostatin LAR intramuscular injection
15748642|NCT04871412|Dietary Supplement|Theracurmin 2X|1.2g twice daily after the peri-operative period. including during adjuvant chemotherapy and radiation
15748643|NCT04871412|Dietary Supplement|Green Tea Extract|700 mg twice daily after the peri-operative period. Will not be given during adjuvant radiation or chemotherapy treatments.
15748644|NCT04871412|Other|Nutrition Recommendations|Based on the Mediterranean diet and lower glycemic index foods
15748645|NCT04871412|Other|Physical Activity Recommendations|150 minutes moderate intensity aerobic exercise per week plus the addition of a resistance exercise program on 2 of those days
15748646|NCT04871412|Behavioral|Psychological Recommendations|Activities with the intention of actively improving the participant's mental and emotional health
15748647|NCT04871399|Procedure|Conventional Right hemicolectomy (Non-CME)|Transecting the Ileocolic Vein and Artery close to the Superior Mesenteric Vessels without clearing the superior mesenteric vein (SMV) from the adipose tissue. Transecting the Right Colic Vein and Artery and superior right colic vein (when present) peripherally. Transecting the Right branches of the Middle Colic Vein (MCV) and the Middle Colic Artery (MCA) peripherally, without clearing the main trunk of the MCV and the MCA. The Right Gastroepiploic Vein and artery are never transacted.
15748648|NCT04871399|Procedure|Right hemicolectomy with CME+CVL|"Separation of the visceral fascia from the parietal fascia by sharp dissection leaving intact mesocolon coverage. Transecting the supplying vessels at their origin from the main vessels, particularly:
~The Ileocolic Vessels, The Right Colic Vessels,The superior right colic vein (when present), The Right branches of the Middle Colic Vein and of the Middle Colic Artery
~The MCV and MCA at their origin in case of cancer of the hepatic flexure or of the proximal third of the transverse colon, as well as The Right Gastroepiploic Vessels at their origin from the gastrocolic trunk of Henle (GCTH) and the gastroduodenal artery.
~The SMV should be cleared from all adipose tissue all along its anterior surface until its intrapancreatic entrance."
15748649|NCT04871386|Behavioral|Acceptance and commitment therapy (ACT) exercises|The ACT group received 14 (partially succeeding) daily exercises, with each of the following categories being focused twice: Acceptance, contact with the present moment, cognitive defusion, self as context, personal values and committed action. The exercises consisted of metaphors and questions for self-reflection, explanations about emotions and thoughts with techniques to handle them differently, as well as a body scan.
15748650|NCT04871386|Behavioral|Positive psychology (PP) exercises|The PP group received 14 daily exercises that were derived from positive psychology interventions that have been proven effective in alleviating clinical symptoms and increasing subjective well-being. In detail, these were: Identifying positive emotions and ways to increase them; Enhancing pleasure from daily activities; Writing a gratitude letter; Identifying and appreciating three personal traits; Receiving a letter of support from one's future self; Taking different perspectives on one's current situation; Envisioning a perfect day; Identifying energy boosters and drainers; Identifying 3 character strengths and using one in a new way; Life review: Writing a legacy; Identifying the positive relationships in one's life; Doing an act of kindness; Three good things; and Coping with failure.
15748651|NCT04871373|Behavioral|Motivational interviewing|A periodontist was trained and evaluated by two expert psychologists in MI, who also supervised the interviewer to ensure that the intervention was properly applied. The periodontist conducted sessions of motivational interviewing monthly to the participants of the experimental group.
15748652|NCT04871373|Behavioral|Oral Hygiene Instructions|A periodontist delivered OHI to all the participants of both studied groups. Also, every single patient received a G.U.M. kit with special orthodontic hygiene tools.
15748653|NCT04871360|Dietary Supplement|L-Citrulline supplement|The intervention will consist of oral supplementation of six grams of pure l-citrulline for eight weeks.
15748654|NCT04871360|Dietary Supplement|Carboxymethyl cellulose supplement|The intervention will consist of oral carboxymethyl cellulose supplementation as a placebo.
15748655|NCT04871347|Drug|TWP-101|IV infusion
15748656|NCT04871334|Drug|TWP-101|IV infusion Q2W for 4 weeks (28-day cycles)
15748657|NCT04871321|Drug|nab-paclitaxel plus gemcitabine-cisplatin|- gemcitabine 800mg/m2 + cisplatin 25 mg/m2 + nab-paclitaxel 100mg/m2 on day 1 and day 8, every 21 days
15748658|NCT04871308|Drug|Dexmedetomidine|"Anesthesia is induced using midazolam or etomidate, and sufentanil. A target-controlled infusion of propofol and remifentanil is used for anesthesia maintenance.
~From anesthesia induction before the initiation of cardiopulmonary bypass, dexmedetomidine is infused intravenously at a rate of 0.5 mcg/kg/hr after a loading dose infusion of 0.75 mcg/kg for 10 mins."
15748659|NCT04871308|Drug|Control|During the same time window for dexmedetomidine, normal saline is infused at the same rate calculated for dexmedetomidine.
15748660|NCT04871295|Behavioral|Noom Healthy Weight|Behavioral: Noom Healthy Weight; mobile behavior change program for weight loss with 1:1 coaching The intervention consists of a curriculum, provided through daily articles that users are encouraged to read; logging features for weight, meals, and physical activity; in-app groups; and a virtual coach, who will communicate with participants via in-app messaging. During the first week of the study, participants will be introduced to the program, the Noom app, and their coach. Coaches will use a secure dashboard to monitor patient progress, which is used to increase engagement and motivation. Participants are encouraged to log their weight and physical activity on a weekly basis, and meals daily.
15748663|NCT04871269|Drug|Dronabinol|Dronabinol
15748664|NCT04871269|Drug|Placebo|Placebo
15748665|NCT04871256|Procedure|Septorhinoplasty|This intervention will be performed by the same surgeon, after signing of patient inform consent.
15748666|NCT04871243|Other|Qualitative Interview|Individual semi-structured interviews
15748667|NCT04871230|Diagnostic Test|3G DBS|Collection of capillary blood samples for the 3G q-PCR test
15748668|NCT04871230|Diagnostic Test|Sputum Test|Collection of sputum for test culture, microscopy, GeneXpert
15748669|NCT04871230|Diagnostic Test|3G Veinous Blood|Collection liquid veinous blood for the 3G q-PCR test
15748670|NCT04871217|Diagnostic Test|68Ga-NODAGA-RGD PET-imaging|Patients will undergo cardiac 68Ga-NODAGA-RGD PET in order to detect myocardial αVβ3 integrin expression 3-14 days after an acute myocardial infarction or within 4 weeks before and 2 weeks after re-opening of chronic coronary occlusion. Echocardiography of cardiac function will be performed at the time of PET imaging and repeated 6 months later.
15748672|NCT04871191|Drug|Rituximab|375 mg/m²/week for four consecutive weeks (Week 0, 1, 2 and 3) Maintenance rituximab at a fixed dose of 500 mg will be administered at week 24 and at week 52.
15748673|NCT04871191|Drug|Tocilizumab|Subcutaneous injection of 162 mg per week
15748674|NCT04871191|Drug|Abatacept|Subcutaneous injection of 125 mg per week
15748675|NCT04871178|Behavioral|Mindfulness-based intervention|"Eight, 2-hour instructor-led MBI group sessions once a week for 8 weeks, combined with formal meditative training at home for 20 minutes per day, 6 days a week.
~Course material consists of facts booklet, weekly training manuals, audio recordings on a CD, with the five formal guided meditative exercises (body scan, breathing anchor, breathing space, mindful movements, sitting meditation).
~The weekly home-work also included informal training of being present in daily life activities.
~The program is provided according to the standard MBI protocol. Compared to MBSR and MBCT durations of formal meditative practices are shorter and no 'all-day in silence' session is included. Because of participants' physical limitations and safety, the 'mindful movements' sequence, is adapted and performed in a sitting position.
~Adherence to the MBI was followed by self-reported weekly training in manuals asked to be submitted at group sessions."
15748676|NCT04871165|Diagnostic Test|S-binding IgG, RBD-binding IgG and N-binding IgG immunoassays and SARS-CoV-2 serum neutralization assay, quantitative serum immunoglobulin tests|S-binding IgG, RBD-binding IgG and N-binding IgG immunoassays and SARS-CoV-2 serum neutralization assay, quantitative serum immunoglobulin tests.
15748677|NCT04871165|Diagnostic Test|Assessment of proinflammatory cytokine production and immunophenotypic analysis after stimulation with overlapping S-peptides in peripheral blood mononuclear cells (PBMC)|Quantitative evaluation of proinflammatory cytokine (IFN-gamma, IL-2 and IL-4) production after stimulation with overlapping S-peptides in peripheral blood mononuclear cells and immunophenotypic analysis (CD45, CD3, CD4, CD8, CD16, CD56, CD14, CD19)
15748678|NCT04871152|Drug|OnabotulinumtoxinA|To compare the effectiveness of triptans before and after initiation of treatment with OnabotuliumtoxinA.
15748679|NCT04871139|Procedure|Biopsy|Undergo biopsy
15748680|NCT04871139|Procedure|Contrast-Enhanced Mammography|Undergo CEM
15748681|NCT04871139|Other|Questionnaire Administration|Ancillary studies
15748682|NCT04871139|Other|Radioactive Iodine|Given IV
15748683|NCT04871126|Other|inflammatory indexes and CHA2DS2-VASc score|inflammatory indexes and CHA2DS2-VASc score
15748685|NCT04871100|Behavioral|Unified Protocol- Alcohol|Transdiagnostic cognitive behavior therapy for emotional disorders modified to include CBT for alcohol use.
15748686|NCT04871100|Behavioral|Problem Solving therapy|Skills based approach for managing negative moods and stress.
15748687|NCT04871087|Device|Green Light|"The Allay Lamp is a consumer product currently available and widely used in the US. It emits low intensity (1-10lux)narrow band (20nm) green light (peak wavelength 520nm) that is marketed as non-irritating to users. In that context, it is not a medical device and does not require a 510(k). However, we believe that light likely also has benefits for sleep. To better understand its effects,we are planning to conduct the proposed study. In that context, the Allay Lamp would be considered an investigational medical device because it has not been cleared or approved by FDA for the intended purpose of treating sleep. No FDA submission should be necessary for this study using 21 C.F.R. 812.3, because the Allay Lamp is a non-significant risk (NSR) device:
~It is not an implant It is not intended for use in supporting or sustaining human life The Allay Lamp provides a very low risk light-based therapy. The light provides no more risk than any other table lamp available on the market today."
15748688|NCT04871074|Drug|UCB-J|PET imaging with UCB-J
15748689|NCT04871061|Procedure|PENG Block|Pericapsular Nerve Group Block
15748690|NCT04871061|Drug|Conventional opioid analgesia (Fentanyl)|standardised intravenous opioid
15748691|NCT04871048|Device|Transcranial direct current stimulation (tDCS) active|Stimulation will be performed using a Neurocan DC-Stimulator Plus with two 7×5 cm sponge electrodes soaked in a saline solution. Electrodes will be placed in accordance with the international 10-20 electrode placement system: the anode over F4 (right DLPFC), the cathode over Fp1 (MPFC). The stimulation level will be set at 2 mA for 20 minutes during stimulation sessions twice a day (separated by at least 3 hours) for 5 consecutive weekdays.
15748692|NCT04871048|Device|Transcranial direct current stimulation (tDCS) non active|The control group will receive the sham stimulation following the same regimen, using the sham procedure which has been developed by the manufacturer of the tDCS material, allowing sensations to be felt in the scalp which are the equivalent to those of the active stimulation. The same device will be used for both the sham and the active procedures.
15748693|NCT04871035|Device|Immunoadsorption|1 cycle, consisting of 5 sessions on 5 consecutive days with processing of the 0.7-fold individual plasma volume (maximum 2.5 l) each days with tryptophan adsorbers.
15748694|NCT04871035|Device|Plasma Exchange|1 cycle, consisting of 5 sessions on 5 consecutive days with exchange of 0.7-fold plasma volume (maximum 2.5 l) each day with albumin solution as volume replacement solution.
15748695|NCT04871022|Procedure|Double layer closure of the hysterotomy|Double layer closure with a first continuous unlocked suture of the deep portion of the myometrium and a second unlocked continuous suture that approximate the upper portion of the myometrium.
15748696|NCT04871022|Procedure|Purse closure of the hysterotomy|Purse suture of the uterus with a first continuous purse suture of the deep portion of the myometrium and a second unlocked continuous suture including the remaining part of the myometrium
15748697|NCT04871009|Behavioral|Neurofeedback Intervention|"InteraXon, Inc. produces the MUSE 2 wearable neurofeedback device and mobile application (heretofore referred to as the MUSE app), respectively comprising the electroencephalogram (EEG) hardware and interactive software components that will be used in this intervention. The MUSE 2 is an adjustable headband that is placed across the forehead and over and behind the ears. It contains EEG sensors for active sites across the forehead and behind the ears, and an additional reference site behind the ear. These sensors use EEG technology to passively record children's brainwaves. During a session, caregivers will help children place the MUSE 2 on their heads and connect it to the app on their personal device. Children's brain activity is recorded by the MUSE 2 and is represented on the app through audio-based feedback that children will listen to with earbuds, and use their volition to influence in real time, with the goal of gaining increased control over their own brain activity."
15748698|NCT04871009|Behavioral|standard of care|trauma focused cognitive behavioral therapy or other behavioral therapy at the discretion of therapist
15748699|NCT04870996|Device|tDCS|tDCS was applied using the StarStim 8 (NeuroElectrics, Barcelona, Spain). tDCS with strength of two milliamps for 20 minutes was applied based on montage recommended (Hoy et al., 2014). The stimulation electrode was applied according to international EEG system 10-20. The anode was applied at the left dorsolateral prefrontal cortexDLPFC, which was located at F3; the cathode was applied at the right dorsolateral prefrontal cortexDLPFC, which was located at F4. In the tDCS group, the participants received 'ramp-up' of 30 seconds, followed by active stimulation with a steady current of two milliamps for 20 minutes, then 'ramp-down' of 30 seconds. In the sham group, the current was only delivered in the 30-second 'ramp-up' and 30-second 'ramp-down' period.
15748700|NCT04870996|Behavioral|Cognitive Training|All participants received the same program of cognitive training in the app 'the Peak' on a hand-held portable iPad (https://www.peak.net/science/). The traditional Chinese version with Cantonese instructions was selected. The progress, the errors, and the sum scores were stored in the personal profile for interactive feedback on adjusting the difficulty level. The participants performed the tasks in pseudorandomized order during each session. Each training session lasted for 20 minutes, concurrent with either active or sham tDCS stimulation.
15748701|NCT04870957|Behavioral|PainGuide|A 4-week, online, self-management program for pain known as PainGuide (online or smart phone). Participants will use this during the run-in period as well as after the run-in period.
15748702|NCT04870957|Behavioral|MBSR|"In this group (mindfulness-based stress reduction) participants will take part in 9 group sessions.
~The groups sessions will be divided into 8 weekly 2-hour groups sessions and one 6-hour retreat. During the sessions participants will practice mindfulness exercises directed by the a MBSR therapist. Additionally, participants will also be asked to practice daily formal mindfulness at home using audio recordings of 30-45 minute guided meditation exercises. These audio recordings can be accessed online. The sessions may take place in-person or virtually."
15748703|NCT04870957|Behavioral|PT and exercise|"Participants will take part in 10 physical therapy visits over the course of 8 weeks. Participants will meet with the physical therapist twice a week for a 1-hour session for weeks 1 and 2 and then weekly for the remaining 6 weeks. The physical therapist will tailor a program to the participant's needs according to recommended PT practice guidelines that will include in-person treatment, home exercise prescription, and encouragement of progressive, low-intensity, submaximal fitness and endurance activities, such as walking.
~Participants will be given a home program of exercises to be done daily and asked to engage in daily walking with a set goal based on the individual's capacity and current fitness level. Walking was selected as the aerobic exercise of focus for this treatment because it is recommended for patients with all levels of pain severity, is highly feasible to complete, and has shown effects on outcomes such as pain and disability."
15748704|NCT04870957|Device|Self -administered acupressure|"A device called the AcuWand will be used to administer the self-acupressure intervention for approximately 30 minutes daily for 8 weeks. Participants will use a mobile application (app) called MeTime that will have daily instructions on how to use the AcuWand. Research staff will show participants how to use the AcuWand and MeTime app. In addition, participants will keep a daily log to track at-home acupressure sessions."
15748705|NCT04870957|Drug|Duloxetine|For days 1-7, patients will take 30mg of duloxetine once a day, in the morning. Starting day 8, participants tolerating the medication will be escalated to 60mg once a day. They will also have the option of staying at 30mg, once a day or stopping the medication. At the end of the 8-week intervention period, participants will have the option to continue the medication commercially (non-study medication) under the care of their physician or taper off the medication. During the entire 8-week intervention, patients will be asked to keep a daily log of medication dosage, any missed doses, and any side-effects they may have experienced.
15748706|NCT04870957|Device|Pro-Diary monitor|"Participants will wear during 5 separate 7-day home monitoring periods to assess physical activity (objectively measured via accelerometry), and ecological momentary assessment (EMA) of mental and physical symptoms. EMA will be collected during Weeks 1, 6, 15, 24 and 36."
15748707|NCT04870944|Drug|FACT Complex-targeting Curaxin CBL0137|Given IV
15748708|NCT04870931|Procedure|TEM / TEM-ESD|Transanal local excision of a rectal tumour as a conventional, full-thickness TEM or submucosal dissection as TEM-ESD
15748709|NCT04870918|Behavioral|self-care intervention|Health education will be carried out by the nurse.
15748710|NCT04870905|Drug|Tis-U-Sol|Tislelizumab 200mg will be given every 3 weeks for 12 cycles
15748711|NCT04870879|Procedure|Liver Transplant|Liver Transplant from cadaveric donors
15748712|NCT04870879|Drug|Chemotherapy|Chemotherapy
15748713|NCT04870866|Drug|Nicotinamide ribonucleoside|Two year intervention
15748714|NCT04870853|Other|Electronic Health Record Review|Medical records reviewed
15748715|NCT04870840|Radiation|Proton Beam Radiation Therapy|Undergo radiation therapy
15748716|NCT04870840|Other|Quality-of-Life Assessment|Ancillary studies
15748717|NCT04870840|Other|Questionnaire Administration|Ancillary studies
15748718|NCT04870814|Device|Tactical tourniquet set up|The tactical tourniquet will be set up to the upper limb and the lower limb during a maximum of 2 minutes.
15748719|NCT04870814|Diagnostic Test|Medical ultrasound|The efficacy of tactical tourniquet set up will be assessed by medical ultrasound.
15748720|NCT04870814|Other|Questionnaire|"The participants will have to fill a questionnaire assessing pain (for the receiver), ease of use, stability and rusticity (for the fitter)."
15748721|NCT04870801|Drug|Respirogen Micro-Oxygen|Enteral (rectal) delivery of Respirogen Micro-Oxygen
15748722|NCT04870788|Behavioral|Mindfulness Relaxation|Participate in mindfulness program
15748723|NCT04870788|Other|Quality-of-Life Assessment|Ancillary studies
15748724|NCT04870788|Other|Questionnaire Administration|Ancillary studies
15748725|NCT04870775|Behavioral|Mindfulness Training Program|Mindfulness training program to reduce psychotropathological symptoms in hospital workers
15748728|NCT04870749|Diagnostic Test|IPP,IPSS,VPSS|Prostate volume, IPSS, VPSS and IPP were determined after urological examinations of the patients.
15748729|NCT04870736|Procedure|Mout-to-mouth ventilation|Chest rising during basic life support will be recorded as No breath (no visible chest rising) and Breath (chest rising) by the observer.
15748730|NCT04870736|Procedure|Mout-to-mouth ventilation with quantitative analysis|Chest rising during basic life support will be recorded and evaluated (breath by breath) in QCPR Skill Reporter software
15748731|NCT04870723|Behavioral|eHealth for Covid-19 prevention and support|3-session online peer-counseling intervention based on motivational interviewing and psychoeducation
15748732|NCT04870710|Device|transcranial electrical stimulation|Electrical stimulation to the extrastriate visual cortex.
15748733|NCT04870697|Behavioral|ACT intervention|"The components of ACT intervention will include six processes to foster parental PF according to the ACT framework.
~Session one - Generate creative hopelessness and build acceptance. The objective is to help parents know about the ACT intervention and realize the experiential avoidance or emotional control strategies do not work, finally turn attention to more useful strategies.
~Session two - Create space for your thought. The objective is to help parents create a distance from their thoughts and facilitate parents' ability of not being trapped by thoughts.
~Session three - Focus on here and now. The objectives to facilitate parents' experiences of observing self and contact with the present moment but not trapped in the past or future.
~Session four - Commit actions in line with the value. The objectives to help parents identify their inner value and take value-based actions even facing the challenges in current difficulties of their children with cancer."
15748734|NCT04870697|Other|Usual care|Usual care in this study setting includes providing general information, education, psychological support, and consultation.
15748735|NCT04870684|Other|thromboelastometry test|This study does not modify the usual care of the patient. Only 5 citrated tubes (maximum 15 mL of blood) are collected in addition to the initial emergency department sample (routine care). The patient's care follows the classic thrombolysis alert pathway. There is no additional complementary examination or additional neurological evaluation. Clot formation kinetics will be evaluated by thromboelastometry to determine the predictive parameters of revascularization. Clot formation and lysis parameters as well as revascularization according to thrombo-inflammation processes will be studied.
15748736|NCT04870671|Drug|Tenofovir Disoproxil Fumarate|Women will take 1 pill orally according the dosing regimen of the arm to which they are assigned
15748737|NCT04870658|Procedure|Dental implant treatment|Patients who receive one o more dental implant treatment to restore oral function.
15748738|NCT04870645|Procedure|Advanced Magnetic Resonance Imaging|Undergo advanced MRI
15748739|NCT04870645|Procedure|Conventional Magnetic Resonance Imaging|Undergo conventional MRI
15748740|NCT04870632|Other|Education|COPD patients conduct pulmonary rehabilitation for 6 weeks by read an education booklet with words and pictures which is made by the physiotherapist.
15748741|NCT04870632|Other|Video-based pulmonary rehabilitation|COPD patients conduct pulmonary rehabilitation for 6 weeks by watching Youtube videos which were made by the physiotherapist.The patients are monitored by the physiotherapist by weekly phone call and asked to record RPE scores at the RPE form.
15748742|NCT04870632|Other|Booklet-based pulmonary rehabilitation|COPD patients conduct pulmonary rehabilitation for 6 weeks by read an education booklet with words and pictures which is made by the physiotherapist.The patients are monitored by the physiotherapist by weekly phone call and asked to record RPE scores at the RPE form.
15748743|NCT04870619|Other|High Intensity Gait Training|The intervention provided in this project is routinely delivered as a standard of care at the participating sites for patients after stroke that have a goal of walking improvement. The intervention consists of 45-60 minute, physical therapy sessions that occur five days per week (not weekends), focusing on prioritizing stepping practice at higher aerobic intensities during scheduled treatments (target training zone of 70-85% heart rate max (HRmax). Stepping is performed on treadmills and over ground, with safety harness systems and body weight support only as needed to ensure successful stepping. Tasks are progressed by increasing task difficulty as determined by the therapist. Accordingly, practice of non-walking tasks performed during physiotherapy, including bed mobility, transfers, and standing balance/ pre-gait activities, is limited.
15748746|NCT04870593|Behavioral|Information|Elder informed about vaccination.
15748747|NCT04870593|Behavioral|Buddy|"Elder encouraged to get vaccinated using buddy system, whereby he/she is accompanied to the vaccination site by another adult who could also get the vaccine. A potential buddy also given vaccination information and encouraged to help the elder get to the vaccination site so they could both be vaccinated."
15748748|NCT04870593|Behavioral|Gossip intervention|"Members of elder's community asked who in the community is good at spreading information. These gossips then asked to spread information about vaccination of elders. If buddy intervention assigned in community, gossips also asked to encourage their communities to use the buddy system to get elders vaccinated."
15748749|NCT04870593|Behavioral|Information assigned in community|Information intervention assigned for other elders in community.
15748750|NCT04870593|Behavioral|Buddy assigned in community|Buddy intervention assigned for other elders in community.
15748751|NCT04870580|Diagnostic Test|Fluorodopa PET tracer|PET/CT scan using fluorodopa tracer
15748752|NCT04870567|Radiation|Stereotactic ablative radiotherapy|Patients were randomly assigned (1:1) to conventionally high dose rate brachytherapy or stereotactic body radiotherapy. Randomisation was done Chief researcher blinded to patient data by telephone stratification by risk group (low or intermediate).
15748753|NCT04870567|Radiation|High dose rate brachytherapy|Patients were randomly assigned (1:1) to conventionally high dose rate brachytherapy or stereotactic body radiotherapy. Randomisation was done Chief researcher blinded to patient data by telephone stratification by risk group (low or intermediate).
15748754|NCT04870554|Behavioral|Enteric feeding|All subjects will be given nutrition enterally, corresponding to their calculated nutritional needs.
15748755|NCT04870541|Drug|Ondansetron 8mg|Patients receiving 8 mg of ondansetron diluted in 20 ml of 0.9% normal saline over 30 minutes as they arrive to the operating theater(75 patients).
15748756|NCT04870541|Drug|Nefopam Injectable Solution|Patients receiving 20 mg of nefopam diluted in 20 ml of 0.9% normal saline over 30 minutes as they arrive to the operating theater (75 patients)
15748757|NCT04870528|Device|pulsed electromagnetic field device|the pulsed electromagnetic field device treatment parameters will be set as 15 Hz frequency, 20 gauss amplitude, and 20 minutes as total treatment duration.
15748758|NCT04870528|Other|Free weights for Strengthening Exercise|"• Parameters of the exercise program: Intensity : The weight or load the patients lifted is set at 50-60% of their individual 1RM , 3 sets of 10 repetitions during the first week. During the second week, the lifting load is increased to 70-75% (3 sets of 10 repetitions) of their individual 1RM and continued for weeks 2-6. After this, training intensity is increased to 80-85% of the 1 RM and implemented from weeks 7-8.
~Frequency: 3 sessions per week for 8 weeks. Number of repetitions: 3 sets,10 repetitions in each set. Total treatment duration: 8 weeks"
15748759|NCT04870515|Other|Best Practice|Receive standard lifestyle recommendations
15748760|NCT04870515|Other|Dietary Intervention|Receive dietary instructions
15748761|NCT04870515|Other|Exercise Intervention|Complete aerobic and strength/resistance exercises
15748762|NCT04870515|Other|Quality-of-Life Assessment|Ancillary studies
15748763|NCT04870515|Other|Questionnaire Administration|Ancillary studies
15748764|NCT04870502|Drug|Controlled ovarian stimulation by Combined Clomiphene Citrate and Ubiquinol Versus hMG|In group A, controlled ovarian stimulation (COS) was done by Clomiphene Citrate (Fertab® 50 mg tablets, Zynova. SITCO Pharma.) as 150 mg (3 tablets) daily for 5 days (from 2nd day till 6th day of the cycle) together with Ubiquinol (active form of Coenzyme Q10) starting from 2nd day till the day of human Chorionic Gonadotropin (hCG) triggering in a dose of 100 mg capsules orally once daily, immediately after meal (Nutraquinol®; Jamjoom Pharma Nutraceuticals). In group B, Human Menopausal Gonadotropins (hMG) (Merional® 75 I.U. vials, IBSA.) IM was given from 2nd day of the cycle in a dose ranging from 75 to 225 IU according to the patient's response. Patients were instructed not to take any non-study drugs during the whole study period.
15748765|NCT04870489|Combination Product|Isotretinoin and CO2 laser|Patients must complete at least 2 months of Isotretinoin prior to starting the study and then continue it for the duration of the 3 months of treatment with the CO2 laser.
15748766|NCT04870489|Device|Co2 laser|After 6-12 months of no treatment for acne the patient comes to do second side of face only laser treatment
15748767|NCT04870476|Behavioral|"Internet-delivered treatment: One step at the time"|The guided internet treatment program consists of 11 modules (+ 1 module for relatives) activated consecutively over a period of 14 weeks. The content is written psychoeducation, patient videos, audio exercises and exposure exercises. The program is therapist-guided; hence all patients will receive support primarily from a specific therapist during the 14 weeks.
15748768|NCT04870463|Procedure|Maxillary and mandibular Cone Beam Computed Tomography record|A Cone Beam Computed Tomography image of each patient of each group at three different moments of the study (baseline/T0, 8-9 months of treatment/T1 and end of treatment/T2)
15748769|NCT04870437|Other|Extracorporeal phototherapy|The principle of ECP is to collect mononucleated cells from the blood by centrifugation. After purification, the mononucleated cells are incubated ex-vivo with a photo-activatable DNA intercalating agent (8-methoxypsoralen, UVADEX®), then re-injected to the patient.
15748772|NCT04870411|Biological|Blood sample|Humoral and cellular immune response. Sample before vaccination, 1 month, 3 months, 6 months and 12 months post-vaccination
15748773|NCT04870398|Procedure|Vital Pulp therapy-Partial pulpotomy|Removal of inflamed pulp tissue, hemostasis and placement of pulpotomy material
15748774|NCT04870385|Behavioral|5-week prevention program|Online modular psychological prevention program featuring integrated elements of Islamic spirituality and Acceptance and Commitment Therapy (ACT).
15748775|NCT04870385|Behavioral|Control|Control group waitlisted to receive prevention program after completion of final data collection.
15748776|NCT04870372|Drug|Selegiline|Subjects will receive one Selegiline tablet (5 mg) per day administered at breakfast. The initial dose of Selegiline is 5 mg/day and be up-titrated in 2-week intervals in increments of 5 mg up to 10 mg (which can be taken at breakfast or divided doses of 5 mg each taken at breakfast and lunch) according to the investigator's judgment, based on individual clinical response and tolerability.
15748777|NCT04870359|Procedure|Pre-emptive increase of immunosuppressive treatments|"Increase prednisolone to 0.4-0.5 mg/kg/day; taper by 5 mg every 2 weeks to reach 15mg/day; then further reduce by 2.5 mg every 2 week and aim to reach 5-7.5 mg/day after 12 weeks.
~Adjustment of the 2nd agent would be as follows:
~For patients who receive AZA <75mg/day; increase the dose of AZA to 75 mg/day.
~For patients who receive MMF <1g/day, increase the dose of MMF to 1g/day."
15748778|NCT04870359|Drug|Prednisolone and/or AZA/MMF|Prednisolone and/or AZA/MMF
15748779|NCT04870333|Drug|Niclosamide|140μL of a 1% niclosamide ethanolamine solution in each nostril twice daily, equivalent to 1.4mg of niclosamide ethanolamine salt per nostril twice daily, approximately 12 hours apart. Total daily dose 5.6mg niclosamide ethanolamine salt (4.7mg free niclosamide acid). Treatment duration will be 6-9 months or up to 28 days after COVID-19 diagnosis unless hospitalised. Participants hospitalised with a diagnosis of COVID-19 should stop the randomised treatment immediately.
15748780|NCT04870333|Drug|Placebo|140μL of a matching placebo solution in each nostril twice daily. Treatment duration will be 6-9 months or up to 28 days after COVID-19 diagnosis unless hospitalised. Participants hospitalised with a diagnosis of COVID-19 should stop the randomised treatment immediately.
15748781|NCT04870320|Behavioral|Endeavor: Computer-Based Cognitive Stimulation Intervention|Endeavor application will be utilized by participant on iPad
15748782|NCT04870320|Behavioral|Words!: Computer-Based Cognitive Stimulation Intervention|Words! application will be utilized by participant on iPad
15748783|NCT04870320|Other|Quality of Life (QOL) Questionnaires|Standardized QOL questionnaire will be administered at each study visit
15748784|NCT04870307|Other|Dissemination and Implementation Research|Dissemination and Implementation research involves assisting primary care practices to address SARS-CoV-2 testing using evidence-based practices as well as increased testing in mobile-based community settings. The D&I model also involves Practice Assessment, Academic Detailing, Practice Facilitation, Health Information Technology Support, Performance Feedback and Benchmarking, and a Virtual Learning Community.
15748785|NCT04870294|Device|Teeth treated with composite resin, control group|The teeth grouped in group R were treated with composite resin restoration without liner material.
15748786|NCT04870294|Device|Teeth treated with lining, pulp wall with PBS DTA® cement and composite resin restoration|The teeth grouped in group D received PBS CIMMO DTA® as indirect capping material of the cavity, followed by restoration of composite resin.
15748788|NCT04870268|Procedure|percutaneous drainage|
15748789|NCT04870268|Procedure|endoscopic approach|
15748790|NCT04870268|Procedure|surgical internal derivation of WON|
15748791|NCT04870268|Procedure|surgical necrosectomy|
15748792|NCT04870255|Device|Left Dorsolateral Prefrontal Cortex (L-DLPFC)|"Participants who are randomly assigned to this group will receive active iTBS (intermittent theta burst stimulation) to the left DLPFC. Stimulation intensity will be standardized at 90% of resting motor threshold (adjusted for cortical depth).
~Stimulation will be delivered using the Magventure Magpro X100 TMS system."
15748793|NCT04870255|Device|Dorsomedial Prefrontal Cortex (DMPFC)|"Participants who are randomly assigned to this group will receive active iTBS (intermittent theta burst stimulation) to the DMPFC. Stimulation intensity will be standardized at 100% of resting motor threshold (adjusted for cortical depth).
~Stimulation will be delivered using the Magventure Magpro X100 TMS system."
15748794|NCT04870255|Device|Sham Stimulation|"Participants who are randomly assigned to this group will receive sham stimulation to the left DLPFC.
~Sham stimulation will be delivered using the Magventure Magpro X100 TMS system."
15748795|NCT04870242|Other|Observational study, non-interventional|observational study for the ERAS protocols in pediatric surgery
15748796|NCT04870229|Drug|Carnosine|
15748797|NCT04870229|Drug|Placebo|Placebo
15748798|NCT04870216|Other|Questionnaire regarding intimate protections habit.|Questionnaire regarding intimate protections habit.
15748799|NCT04870203|Drug|baricitinib treatment|4 mg daily during 12 months
15748800|NCT04870203|Drug|adalimumab|40 mg every 2 weeks during 6 monts
15748801|NCT04870203|Drug|Placebo|40 mg every 2 weeks during 6 months
15748802|NCT04870190|Drug|Almonertinib|Almonertinib will be administered orally at a dose of 165 mg per time, Q.D.
15748803|NCT04870190|Drug|Osimertinib|Osimertinib will be administered orally at a dose of 80 mg per time, Q.D.
15748804|NCT04870177|Drug|AK112|AK112 infusion biweekly
15748805|NCT04870164|Drug|Ensovibep|The study will start with a low-dose cohort and after a safety review escalate to the higher dose cohorts. 3 IV infusion, 2 IV bolus, 4 subcutaneous and 4 intramuscular cohorts are planned. Subjects receive one or two administration(s) on day 1, depending on the cohort.
15748806|NCT04870164|Drug|Placebo|One administration at day 1 by infusion.
15748807|NCT04870151|Procedure|Anterolateral approach|Cemented hemiarthroplasty using an anterolateral approach.
15748808|NCT04870151|Procedure|Direct lateral approach|Cemented hemiarthroplasty using a direct lateral approach.
15748809|NCT04870138|Drug|Azithromycin|Alternative antibiotic treatment failure therapy: Azithromycin 2 g orally in a single dose after treatment failure with both cephalosporin and quinolone antibiotics.
15748810|NCT04870138|Drug|Ceftriaxone|Mandatory antibiotic treatment failure therapy: Ceftriaxone 250 mg intramuscular in a single dose on patient request, at the onset of symptoms, or on the 5th study day after inoculation.
15748811|NCT04870138|Drug|Ciprofloxacin|Mandatory antibiotic treatment failure therapy: Ciprofloxacin 500 mg orally in a single dose on patient request, at the onset of symptoms or on the 5th study day after inoculation.
15748812|NCT04870138|Biological|Neisseria gonorrhoeae strain FA1090 A26|0.4 mL of a suspension containing 10^5 - 10^6 CFU of wild-type (WT) Neisseria gonorrhoeae, in phosphate-buffered saline, delivered to the anterior urethra through a No.8 pediatric French catheter.
15748813|NCT04870138|Biological|Neisseria gonorrhoeae strain FA7527|0.4 mL of a suspension containing 10^5 - 10^6 CFU of isogenic LptA mutant Neisseria gonorrhoeae, in phosphate-buffered saline, delivered to the anterior urethra through a No.8 pediatric French catheter.
15748814|NCT04870125|Drug|Inhaled Carbon Monoxide at CFK equation-determined personalized dose (200-500 ppm to achieve a COHb level of 6-8%)|Inhaled Carbon Monoxide at CFK equation-determined personalized dose (200-500 ppm to achieve a COHb level of 6-8%) for up to 90 minutes daily for 3 days.
15748815|NCT04870125|Other|Inhaled Medical air|Inhaled Medical Air for up to 90 minutes daily for 3 days.
15748820|NCT04870099|Behavioral|Doing What Matters in Times of Stress: An Illustrated Guide|"From the WHO's website: Doing What Matters in Times of Stress: An Illustrated Guide is a stress management guide for coping with adversity. The guide aims to equip people with practical skills to help cope with stress. A few minutes each day are enough to practice the self-help techniques. The guide can be used alone or with the accompanying audio exercises.
~Informed by evidence and extensive field testing, the guide is for anyone who experiences stress, wherever they live and whatever their circumstances."
15748821|NCT04870073|Procedure|Retrograde autologous priming|Priming solution (≥600 mL) will be removed from the extracorporeal circuit within 10 minutes before the initiation of cardiopulmonary bypass. Priming solution may be removed from 3 locations within the extracorporeal circuit (i.e. arterial, venous and cardioplegia lines) as determined by the perfusionist team.
15748822|NCT04870073|Drug|Mannitol|Mannitol will be added as a bolus (0.3 g/kg) to the venous reservoir of the cardiopulmonary bypass machine within 5 min before the start of cardiopulmonary bypass.
15748823|NCT04870073|Procedure|Conventional Priming|The conventional priming procedure will be used in the standardized cardiopulmonary machine used at the Hamilton General Hospital.
15748824|NCT04870060|Drug|Curcumin Lozenges|Curcumin lozenges - 4 lozenges to be chewed BD. Each lozenge contained 100 mg of curcumin and the formulation was Solid Lipid Curcumin Particle (SLCP)
15748825|NCT04870047|Device|Endovascular treatment of unruptured aneurysms with p48/p64 MW HPC Flow Modulation Device|Patients suffering from a distal intracranial aneurysm will be treated endovascularly with the p48/p64 MW HPC Flow Modulation Device.
15748829|NCT04870021|Biological|recombinant hepatitis B vaccine ENGERIX 10 micrograms (µ gm),|recombinant hepatitis B vaccine ENGERIX 10 micrograms (µ gm), intramuscular in the anterolateral part of either of thighs
15748830|NCT04870021|Behavioral|Short text messages and calls to parents for compliance to routine immunization schedule|After the discharge of mothers from hospital, preformed, short text messages (SMS) were sent to parents, reminding them of the due date for as per the vaccination schedule. One day after the due date of the vaccine shot, a phone call was made to confirm the child was vaccinated or not
15748831|NCT04870008|Procedure|Suture|The side of patient's scar that will receive the sutures placed at 2 or 5 mm from wound edge.
15748832|NCT04869995|Other|Interview|An individual semi-structured interview per surgeon, according to an interview guide.
15748833|NCT04869982|Biological|RZV|2 doses of RZV in 0, 2 months schedule, administered intramuscularly in the deltoid region of the non-dominant arm
15748834|NCT04869982|Drug|Placebo|2 doses of placebo in 0, 2 months schedule, administered intramuscularly in the deltoid region of the non-dominant arm
15748835|NCT04869969|Procedure|percutaneous nephrolithotomy (supine position)|percutaneous nephrolithotomy to be done in the supine position
15748836|NCT04869969|Procedure|percutaneous nephrolithotomy ( prone position)|percutaneous nephrolithotomy in the prone position
15748837|NCT04869956|Dietary Supplement|Intervencion|high-fiber diet rich in PUFAs (total dietary intake of at least 30 grams of fiber per day, and of at least 3 grams of PUFAs per day from food, not supplements) at least 4 weeks before surgery
15748838|NCT04869956|Other|standard|standard nutritional recommendations
15748841|NCT04869930|Other|specimen collection|participants will submit at minimum two of four required samples: fecal, urine, finger/toe-prick blood, and cheek swab, collected at home via commercially available kits
15748842|NCT04869917|Behavioral|In-person intervention|"Displays information about the benefits and risks of ILI and metformin
~Asks open-ended questions: What am I willing to do to prevent T2D? and What do I need to prevent T2D?
~Prompts patients to commit to immediate next steps
~Health educator schedules interested patients for first ILI session or sends message to provider about patients' interest in starting metformin, if chosen"
15748843|NCT04869917|Behavioral|Automated intervention|"Defines prediabetes and includes individualized A1c values
~Present benefits and risks of intensive lifestyle intervention and metformin
~States that other prediabetic Erie patients are adopting intensive lifestyle intervention and metformin
~Encourages initiating intensive lifestyle intervention or discussing metformin with provider
~Include selected behavioral content from diabetes prevention program
~Initial message with automatic opt-in, allows opt-out for messages
~Subsequent messages include: information about T2D risk and treatments; prompts to directly schedule intensive lifestyle intervention or office visit to discuss metformin; selected behavioral content from diabetes prevention programming"
15748844|NCT04869917|Behavioral|Usual Care|Patients receiving care at non-intervention clinic sites will not be exposed to treatment intervention.
15748845|NCT04869904|Procedure|dental and plaque sampling|sampling of dental plaque and saliva during the treatment
15748846|NCT04869865|Dietary Supplement|9-day detoxification cleanse and 1 week of pre-cleanse transition|Subjects will participate in the full 9-day Springtime Home Cleanse, including the week prior to a pre-cleanse transition period. The cleanse includes a transition week, 9 days of a monodiet, internal oleation with ghee, external oleation, herbs, purgation, and an enema. During this time, subjects will also attend daily online meetings on Facebook Live throughout the cleanse and on AyurPrana's AyurLearn online portal to participate in guided mediation and yoga. Subjects will also use these platforms to access daily cleanse instructions and journaling topics.
15748847|NCT04869852|Other|Food|85g mango, 4x/week
15748848|NCT04869839|Other|oral examination|examination done by dentist
15748849|NCT04869826|Device|Pulsewave Health Monitor (PAD-2A) Device|This is an observational, comparison study of blood pressure measurements. The objective of this study is to calibrate the blood pressure measurements of the Pulsewave Health Monitor (PAD-2A) device to be within 5±8 mmHg of the average of the dual-observer auscultatory blood pressure measurements via an aneroid sphygmomanometer (reference device), as per the ISO 81060-2: AMD_2020 universal protocol.
15748850|NCT04869800|Drug|CKD-398|Test Drug
15748851|NCT04869800|Drug|CKD-501, D745|Reference Drug
15748852|NCT04869787|Device|Selective Cytopheretic Device|SCD in line with CRRT extracorporeal device
15748853|NCT04869774|Device|How2Trak mobile application|Patients will undergo virtual monitoring of their incision and symptoms using the How2Trak application(app). Using the app, patients will be asked to answer a series of questions and photograph their surgical incision on post-operative day 3, 5, 7, 10, 20, and 30. Patient responses and photographs entered into the app will be reviewed within 72 hours by a trained Nurse Specialized in Wound, Ostomy and Continence. If a concern is identified the nurse will contact the patient to arrange a virtual visit using the how2trak app or notify the surgeon team (including colorectal surgeons and physician residents) in accordance with clinical discretion.
15748854|NCT04869761|Drug|Allogeneic adipose-derived mesenchymal stem cells (MSC)-Single Infusion|Single MSC infusion of 150x10^6 cells at time zero; intravenous delivery
15748855|NCT04869761|Drug|Allogeneic adipose-derived mesenchymal stem cells (MSC)-Two Infusions|Two MSC infusions of 75x10^6 cells at time zero and three months; intravenous delivery
15748856|NCT04869748|Other|Perfetti method|"Participant was blindfolded, while lying flat in a quiet and comfortable room.
~Participants received a 15-minute session of Perfetti method on affected elbow flexor.
~Participants were asked to concentrate on the position of their elbows.
~Protocol has 4 steps of training starting from 2 positions; full flexion and full extension 3 positions; full flexion, elbow flexion 90 degree and full extension 4 positions; full flexion, elbow flexion 110-140 degree, elbow flexion 45-60 degree and full extension 5 positions; full flexion, elbow flexion 110-140 degree, elbow flexion 90 degree, elbow flexion 45-60 degree and full extension of elbow.
~After therapist passively moved elbow joint to a position, participant guessed the position of his/her elbow. If the answers were correct consecutively for 10 times, the therapist increased the number of positions according to the protocol."
15748973|NCT04868734|Behavioral|Supportive Psychotherapy|Supportive Psychotherapy give to patient with Acute Coronary Syndrome
15784610|NCT04576208|Drug|TAK-788|TAK-788 capsules
15748857|NCT04869748|Other|passive stretching|"Participant was blindfolded, while lying flat in a quiet and comfortable room.
~Each participant received gentle passive stretching of elbow flexor and maintained in full elbow extension position for 15 minutes."
15748858|NCT04869735|Other|Data collection: DTPolio vaccine delivery|"with information about booster vaccination group: Sending of information concerning booster vaccination against DTPolio at 25 years using letters, emails and SMS without information about booster vaccination group: no intervention"
15748859|NCT04869722|Behavioral|Liquid Model|Whey protein beverages will be used, with the amount of protein varied to study the effect on perception of the products (using sensory methods rating mouthdrying and discrimination tests 'which sample is more mouthdrying') all measured at home.
15748860|NCT04869722|Behavioral|Solid Model|Protein fortified scones will be used, with the amount of fat varied to study the effect on perception of the products (using sensory methods rating mouthdrying and discrimination tests 'which sample is more mouthdrying') all measured at home.
15748861|NCT04869709|Drug|Betamethasone Sodium Phosphate|Betamethasone Sodium Phosphate 12mg IM q24h for 2 doses
15748862|NCT04869683|Other|description of MDS pzatient cohort|description of MDS patient cohort
15748863|NCT04869670|Procedure|Gastric peroral endoscopic myotomy.|Under propofol anesthesia, EndoFLIP will be used to assess pyloric diameter and distensibility, prior to and after G-POEM, performed by an endoscopist skilled in this technique. After the procedure, the patient will be observed in the hospital for 2 days. Patients will undergo an upper GI series the next day to rule out perforation. If the patient develops a complication from the procedure, he or she will be managed per standard clinical practice by the treating (unblinded) endoscopist.
15748864|NCT04869670|Procedure|Sham Gastric peroral endoscopic myotomy.|Patients assigned to the sham procedure will be treated identically as above, except for the performance of the G-POEM. Endoscopy and EndoFLIP will be performed and sedation will be stopped when the upper endoscopy is completed. Since sham endoscopy is expected to take less time than G-POEM, the patient should remain in the endoscopy procedure room for a minimum of 30 minutes (including the time required to complete the upper endoscopy). After the procedure, the patient will be observed in the hospital for 2 days. All patients will undergo an upper GI series radiographic examination the next day to rule out perforation in order to maintain study blind.
15748865|NCT04869657|Behavioral|Coaches with Children's Hospital of Philadelphia (CHOP) Research Consultant Support|Coaches employed by the school district will support the implementation of three evidence-based practices, while themselves being remotely supported by CHOP research consultants.
15748866|NCT04869657|Behavioral|Coaches without CHOP Research Consultant Support|Coaches employed by the school district will support the implementation of three evidence-based practices without any additional support from CHOP research consultants.
15748872|NCT04869631|Other|The outcome of an intervention is not evaluated, but aortic stenosis and additional amyloidosis are compared.|We aim to compare patients with aortic valve stenosis with and without cardiac amyloidosis.
15748873|NCT04869618|Device|Raman spectroscopy based device (SPECTRA IMDx)|The SPECTRA IMDx system is developed on the basis of Raman spectroscopy. It comprises a laser system, a spectrometer, a computer with an analysis algorithm installed, and other ancillary parts. The SPECTRA IMDx system also comprises a SPECTRA IMDx probe that can be connected with the main system. The SPECTRA IMDx probe is an assembly of optical fibres and optical components arranged for maximal transmission of light energy. When in use, the laser system will emit a 785nm near infra-red laser that will be transmitted through the SPECTRA IMDx probe to the distal end. When the laser is interrogated upon a tissue surface, the light energy is absorbed and reflected. The reflected energy is then collected from the distal end of the SPECTRA IMDx probe, transmitted back to the main system, and passed through the spectrometer. The collected signal is then processed to obtain the clean Raman signal, which is then parsed through an analysis algorithm for diagnosis.
15748874|NCT04869605|Diagnostic Test|1,5 Anhydroglucitol and 1,5 Anhydroglucitol / Glycated Hemoglobin ratio|the role of 1,5 anhydroglucitol and 1,5 anhydroglucitol / HbA1c ratio as a potential biomarker for islet β-cell function and insulin resistance among patients with type 2 diabetes
15748875|NCT04869592|Biological|low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)|Intramuscular injection of low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell) in the deltoid muscle of the upper arm
15748876|NCT04869592|Biological|high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell)|Intramuscular injection of high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell) in the deltoid muscle of the upper arm
15748877|NCT04869592|Biological|placebo|Intramuscular injection of placebo in the deltoid muscle of the upper arm
15748878|NCT04869579|Drug|Selenium (as Selenious Acid)|Interventional arm participants will receive Selenium as Selenious Acid infusion plus the standard of care therapy.
15748879|NCT04869579|Other|Placebo|Active comparator arm participants will receive the standard of care therapy plus a Saline-based placebo.
15748880|NCT04869553|Other|Management pain with distraction methods ABC|"Every patient will receive :
~The usual pain management of their ward (Treatment A),
~The usual pain management of their ward with a hypnosis session (Treatment B)
~The usual pain management of their ward with a virtual reality session (Treatment C)"
15748881|NCT04869553|Other|Management pain with distraction methods BCA|"Every patient will receive :
~The usual pain management of their ward with a hypnosis session (Treatment B)
~The usual pain management of their ward with a virtual reality session (Treatment C)
~The usual pain management of their ward (Treatment A)"
15748974|NCT04868721|Procedure|micro-osteoperforations|three flapless micro-osteoperforations was performed distal to the maxillary canine before starting retraction.
15785274|NCT04570683|Drug|Nivolumab 10 MG/ML|Se previously
15748882|NCT04869553|Other|Management pain with distraction methods CAB|"Every patient will receive :
~The usual pain management of their ward with a virtual reality session (Treatment C)
~The usual pain management of their ward (Treatment A)
~The usual pain management of their ward with a hypnosis session (Treatment B)"
15748883|NCT04869540|Other|Usual care|Evidence based care for transition-aged youth (TAY) with ASD.
15748884|NCT04869540|Other|'Got Transition' toolkit and resources|Providers will be trained in the 'Got Transition' toolkit (the systems level component of the intervention) and have access to web-based transition resources.
15748885|NCT04869540|Behavioral|PSE intervention|A family-based problem solving education (PSE) intervention.
15748887|NCT04869514|Procedure|spinal manipulation|intervention will consist of either lumbar manipulation, thoracic manipulation or lumbar mobilisation
15748888|NCT04869501|Drug|TJ004309|Antibody to CD73
15748889|NCT04869501|Drug|Atezolizumab|Humanized monoclonal antibody to PD-L1
15748890|NCT04869488|Drug|Fluzoparib|Fluzoparib Orally twice daily（Cohort 1）
15748891|NCT04869488|Drug|Enzalutamide OR abiraterone acetate With Prednisone Acetate Tablets|Enzalutamide OR abiraterone acetate Orally once daily（Cohort 1）
15748892|NCT04869488|Drug|Fluzoparib Combined With Apatinib|Fluzoparib Orally twice daily; Apatinib Orally once daily（Cohort 2、Cohort 3）
15748893|NCT04869475|Drug|Arsenic trioxide|This is a single-arm study with all patients receiving arsenci trioxide.
15748894|NCT04869449|Drug|Ketoconazole|400 mg (two 200 mg tablets) orally
15748895|NCT04869436|Drug|Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]|Dupilumab will be administered subcutaneously for 6 months (1 initial 600mg dose + 5 300mg doses every 4 weeks)
15748896|NCT04869423|Behavioral|Dog-Assisted Therapy|During seven weeks patients will assist one time per week (1 hour). The therapy will be conducted by an expert psychologist. The intervention will consist of 7 weeks conducted once a week (50 minutes each session). It will include three parts: 1) a welcome part aimed to get in touch with the dog, 2) a main part, where participants will be taught basic notions about dog training and then try to train the dogs. In this part, the patients will perform different activities and exercises with the dog. 3) A closing part to say goodbye to the dogs.
15748897|NCT04869410|Procedure|Modification Broselow Tape|Intubation using modified Broselow Tape prediction for predicting ETT size
15748898|NCT04869410|Procedure|Cole Formula|Intubation using Cole Formula prediction for predicting ETT size
15748899|NCT04869397|Biological|Allogeneic Wharton's jelly-MSCs (WJ-MSC)|"The product is provided cryopreserved by NextCell Pharma. The cells are frozen in cryobags at a concentration of 2 × 107 cells/ml in 5% Human Serum Albumin (HSA) and 10% dimethylsulfoxide (DMSO). One cryobag contains one dose. The bags are frozen in a controlled rate freezer and directly transferred to -190 ºC for storage until the time of infusion.
~Cryobags are thawed at bedside and diluted in 100 ml of saline prior to administration. Cells will be delivered at a rate of 5 million cells per minute over a total of 20 minutes."
15748900|NCT04869397|Other|Placebo|Sodium chloride buffer supplemented with 5% HSA and 10% DMSO same volume and mode of administration as treatment group
15748901|NCT04869384|Other|Reminders and feedback to improve adherence|Subjects will receive reminders and feedback to improve their adherence.
15748902|NCT04869384|Other|No reminders and feedback to improve adherence|Subjects will not receive reminders and feedback to improve their adherence.
15748903|NCT04869371|Drug|Docetaxel injection|75 mg/m2 body surface area every 3 weeks for 6 cycles before robot assisted radical prostatectomy
15748904|NCT04869371|Drug|Triptorelin Pamoate for Injectable Suspension|15mg every 12 weeks
15748905|NCT04869371|Drug|Prednisone Acetate Tablets|5 mg oral low dose prednisone, once daily
15748906|NCT04869358|Drug|Ofatumumab|Ofatumumab 20 mg s.c. on days 1, 7, 14, week 4 and every 4 weeks thereafter
15748907|NCT04869345|Behavioral|LARKSPUR|This intervention used in our prior research consists of skills training exercises designed to increase the frequency of positive affect. The 6 week intervention (5 weeks of content plus one week of home practice) consists of five components: (1) Positive events and gratitude; (2) mindfulness; (3) reappraisal; (4) strength and goals; and(5) acts of kindness. Participants will have up to 8 weeks to complete this intervention.
15748908|NCT04869332|Device|three cancellous screws|All patients with femoral neck fractures will be randomly divided into 2 groups at a ratio of 1:1. Three screws for internal fixation in the three-screw group, and three cancellous screws with an inverted triangle pattern are used to fix the fracture of femoral neck.
15748909|NCT04869332|Device|four cancellous screws|All patients with femoral neck fractures will be randomly divided into 2 groups at a ratio of 1:1. Four screws for internal fixation in the four-screw group, and the fourth screw will be implanted in the horizontal direction of the femoral distance on the basis of the three screws.
15748910|NCT04869319|Behavioral|MyChart message|Message subjects through MyChart to follow-up with their provider to schedule a follow up HbA1C test.
15748911|NCT04869306|Device|Hyaluronic acid gel|After lower third molar removal, the test group 1 will additionally receive hyaluronic acid gel prior to wound closure.
15748912|NCT04869306|Device|Hyaluronic acid gel + carrier|After lower third molar removal, the test group 2 will additionally receive hyaluronic acid gel with a collagen carrier prior to wound closure.
15748913|NCT04869293|Device|Hypnosis 3D virtual reality headset|3D experience to journey through a natural and therapeutic environment. Immersion is amplified by the realism of 3D environment, a soothing sound atmosphere and specific medical hypnosis.
15748975|NCT04868708|Biological|AK104|Subjects will receive AK104 intravenously.
15785275|NCT04570683|Device|Ablative fractionated laser|Se previously
15748914|NCT04869267|Behavioral|Acceptance and Commitment Therapy (ACT)|"Session 1:
~This session aims to let the participants get familiar with the interventionist. The interventionist will tell them the purpose of the program and basic rules. And the interventionist will promise their privacy protection.
~Session 2:
~This session includes how to separate thoughts/feelings/sensations related to diagnose with advanced lung cancer and experience of fatigue with facts and see these feelings in an objective way with observing self.
~Session 3:
~This session mainly aims to help participants understand the importance of values, differentiate values from goals and clarify their personal values.
~Session 4:
~This session aims at helping patients practice to engaging in committed action based on chosen values, motivated to change behavior in consistency with life direction and health goal."
15748915|NCT04869267|Other|Usual care|The usual care mainly includes treatments and daily care during admission, medication instructions, diet and exercise advice, retest recommendations when discharge
15748916|NCT04869254|Other|Lower lymphocyte/ATG ratio|
15748917|NCT04869254|Other|Higher lymphocyte/ATG ratio|
15748918|NCT04869241|Diagnostic Test|surface EMG|Carrying backpacks forward or backward
15748920|NCT04869215|Other|EverVita Pro|EverVita Pro is composed of barley and corn, grown and mechanically processed in Europe, with non-GMO grains.
15748921|NCT04869215|Other|Control bread|Bread baked with normal Bakers flour
15748922|NCT04869202|Diagnostic Test|COVID-19 test|Naso-pharyngeal swab test
15748923|NCT04869189|Device|JJVC Marketed Contact Lens|Acuvue Oasys® 1-Day
15748924|NCT04869176|Diagnostic Test|Electrocardiogram|Recording of the electrical activity of the heart during sleep; sleep phases were evaluated. The bed was initially in horizontal position and tilted for 30° head-up after 20 minutes of continuous tracing.
15748925|NCT04869176|Diagnostic Test|Monitoring of vital functions|Measuring of heart rate, breathing frequency, arterial oxygen saturation and body temperature while recording ECG.
15748926|NCT04869176|Drug|Caffeine Citrate 5 mg/kg|Caffeine in the form of suspension was given to the newborns.
15748927|NCT04869163|Other|Non-red meat|Red meat analogues and alternatives
15748928|NCT04869150|Procedure|radial access coronary angiography|The right radial artery was cannulated with a 6-f radial sheath after local infiltration with 2% lidocaine.All patients received 5000 units of unfractionated heparin, 100 - 200 μg (depending on blood pressure) of nitroglycerin and 5 mg of diltiazem unless there was an absolute contraindication to diltiazem and anticoagulants.Coronary angiography was performed using the standard Judkins' technique via right radial access with a 5-f diagnostic catheter
15748929|NCT04869137|Drug|Lenvatinib Oral Product|20mg of Lenvatinib will be taken orally once daily
15748930|NCT04869137|Drug|Pembrolizumab|200mg of Pembrolizumab will be administered through IV infusion every 3 weeks.
15748931|NCT04869124|Drug|Dapagliflozin|Dapagliflozin propanediol (FORXIGA) tablet: 10 mg once daily p.o. on top of recommended standard therapy, duration of administration: 12 weeks.
15748932|NCT04869124|Drug|Placebo|Placebo tablet, matching Dapagliflozin, once daily p.o. on top of recommended standard therapy, duration of administration: 12 weeks.
15748933|NCT04869111|Behavioral|Online SMART & Stress Solutions|"On-line SMART - (Strategic Memory Advanced Reasoning Training) is a curriculum that teaches strategies of how to use the brain better, in such a way that may improve brain health and performance. SMART strives to achieve optimal cognitive function realized by the brain's ability to efficiently manage complex information by abstracting its essential meaning rather than attempting to memorize details, and to prioritize the information in order to attend to the most relevant parts.
~Stress Solutions - provides individuals with practical tools to enhance performance, reduce stress, build resilience and improve quality of life.
~Brain-Healthy Habits - daily reminders of habits you can track"
15748934|NCT04869098|Dietary Supplement|whey protein|Protein drink containing 30g whey protein isolate powder (dissolved in water) consumed 1-1.5 hr prior to their main evening meal every day for 12 days, No other advice will be given.
15748935|NCT04869098|Dietary Supplement|Placebo|Energy-matched mixed-nutrient placebo drink consumed 1-1.5 hr prior to their main evening meal every day for 12 days. No other advice will be given.
15748936|NCT04869085|Behavioral|e-PainSupport|Patients and caregivers assigned to the e-PainSupport condition will download the app on their own device, or they will be given a project tablet with wireless capability if they do not have their own device. All receive specific training for the intervention. They will also receive a hardcopy of the e-PainSupport manual and a trouble-shooting guide. Contact information will be provided in the app and on paper for technical problems. Caregivers complete Education Module, and patients may complete it. Caregiver or patient will fill out Pain Report daily. Pain Summary for Nurses is an automatically generated graphic summary of patients' Pain Reports over time. Nurses have access to this information during the time the patients and caregivers use e-PainSupport.
15748937|NCT04869072|Drug|Convalescent plasma|"Convalescent plasma will be delivered as FFP. Three units of 200ml CP/FFP harvested from one donor will be transfused to one recipient, i.e. there will be a match between donor and recipient and each recipient will receive CP/FFP only from one donor.
~CP/FFP will be administered intravenously at the infusion rate of 100ml/hour, starting from day 0, with a new transfusion every 24 hours, for a total of 3 transfusions (see scheme)."
15748938|NCT04869059|Device|Transcranial direct current stimulation|Transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. Stimulation will consist of 1 milliamp stimulation, with anodal stimulation delivered at electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, then remain at 1 milliamp of stimulation over 20 minutes, and finally ramping down at to 0 milliamps over 60 seconds.
15748939|NCT04869059|Device|sham tDCS|Sham transcranial direct current stimulation will be delivered via a Neuroelectrics Starstim tES. The sham setup will consist of anodal electrode Fz (International 10/10 System for electroencephalography electrode placement) and electrodes F7, FP1, FP2, and F8 as returns. All electrodes are 1 cm diameter Ag/AgCl electrodes and make contact with the scalp via connective gel. Stimulation will linearly ramp up from 0 milliamps to 1 milliamp over 60 seconds, ramp down to 0 milliamps over 60 seconds and then be left off for 20 minutes.
15785276|NCT04570670|Drug|monomethyl fumarate 190 mg|
15748940|NCT04869046|Drug|Instillation of levobupivacaine in surgical wound|Once the hernia tissue had been surgically managed, the wound was sutured in layers and a solution of 0.5% levobupivacaine, 0.5 mg/kg (0.1 ml/kg), was instilled into the wound of children in the experimental group before suturing of the abdominal fascia. That same amount of 0.9% saline was given to children in the control group. The absorption of the solution took approximately 3 minutes, after which the wound was sutured. After completion of wound suturing, all children received 20 mg/kg of paracetamol administered as a rectal suppository.
15748941|NCT04869033|Other|Farinelli's Breathing Exercise|after 1 minute of normal breathing, follow this instruction; inhale 2 seconds, suspend 2 seconds, exhale 2 seconds. inhale 3 seconds, suspend 3 seconds, exhale 3 seconds. inhale 4 seconds, suspend 4 seconds, exhale 4 seconds. inhale 5 seconds, suspend 5 seconds, exhale 5 seconds. inhale 6 seconds, suspend 6 seconds, exhale 6 seconds. This cycle lasted 1 minute (60 seconds), called Farinelli's breathing (FB). When participants finished these cycle, repeated it again 4 times. 1 minute of NB + 4 minutes of FB called 1 set. The participants were asked to practice 6 sets/day, 5 days/week (Monday-Friday) for week 1-4, and increased duration to 8 sets/day, 5 days/week for week 5-8.
15748942|NCT04869033|Other|Diaphragmatic Breathing Exercise|after 1 minute of normal breathing, inhale 2 seconds and exhale 2 seconds with nasal airway. Continued breathing this pattern until 4 minutes, then back to normal breathing 1 minute . 1 minute of NB + 4 minute of DB called 1 set. The participants were asked to practice 6 sets/day, 5 days/week (Monday-Friday) for week 1-4, and increased duration to 8 sets/day, 5 days/week for week 5-8.
15748943|NCT04869020|Device|Otoband|Participants with vertigo will wear the Otoband set at their chosen power level when experiencing symptoms.
15748944|NCT04869020|Device|Sham A|Sham Device A is an OtoBand in which the transducer is modified so that the vibrations are not targeted at the vestibular system.
15748945|NCT04869020|Device|Sham B|Sham Device B is an OtoBand that operates at power settings found to be nontherapeutic against vertigo associated with virtual reality.
15748946|NCT04869007|Device|hysterosonography|Isthmocele mesured by hysterosonography before ART procedure
15748947|NCT04868994|Diagnostic Test|Whole Body MRI and ENMG|Whole body muscle MRI lasting 30 to 45 min without injection of contrast medium an ENMG
15748948|NCT04868981|Drug|GST-HG141 tablets|Administrate GST-HG141 tablets orally in fed state twice daily at 25 mg or 50mg or 100 mg doses
15748949|NCT04868981|Drug|Matching Placebos for GST-HG141 tablets|Administrate the placebos for GST-HG141 tablets orally in fed state twice daily at 25 mg or 50mg or 100 mg doses
15748950|NCT04868968|Drug|DFV890|DFV890
15748951|NCT04868955|Other|Oral screen training|Oral screen training (IQoro®) during 13 weeks.
15748952|NCT04868942|Other|Assisting to the event|"Participant will attend a concert respecting the Following measures :
~Individual protection kit: disposable FFP2 masks (3), Hydroalcoholic solution, disposable tissues, garbage bag, water bottle
~Health mediation, information on barrier measures
~Physical distancing (sitting participation)
~Person flow management"
15748953|NCT04868903|Dietary Supplement|Vitamin D3|Half the subjects will be randomized to the low dose vitamin D therapy (400 IU/day), which will serve as the control group, and half to moderate (4,000 IU/day) or high (10,000 IU/day). Study participants will have the option between being randomized to the low versus moderate or the low versus high dose arms.
15748954|NCT04868890|Biological|Ampion|Inhaled Ampion
15748955|NCT04868890|Other|Placebo|Inhaled Placebo
15748956|NCT04868877|Drug|MCLA-129|In the dose escalation phase 1 part, MCLA-129 will be administered every two weeks with increasing doses to patients with NSCLC or patients with HNSCC, or other solid tumors, who in all cases, have progressed after receiving prior therapy for advanced/metastatic disease. In Part 2, patients with NSCLC and other advanced solid tumors will be dosed with MCLA-129 every two weeks at the RP2D.
15748957|NCT04868864|Diagnostic Test|CT scan|Non-enhanced LDCT scans of the thorax will be taken using standard technology on helical CT system
15748958|NCT04868864|Diagnostic Test|Pulmonary Function Test|Standard pulmonary function testing will be conducted by trained pulmonary technologists following the American Thoracic Society standards
15748959|NCT04868851|Behavioral|Here for Health Only|Patients will complete the Here for Health Healthy Lifestyle intervention designed by the Paediatric Diabetes Dietitians at Oxford University Hospitals NHS Foundation Trust.
15748960|NCT04868851|Behavioral|mHealth technology assisted exercise counselling|Patients will complete the Here for Health intervention before completing a 3 month exercise and physical activity intervention supported by mHealth technology
15748961|NCT04868838|Drug|Daratumumab|1800 mg administered by subcutaneous injection by manual push over approximately 3-5 minutes in the abdominal subcutaneous tissues in the left/right locations, alternating between individual doses.
15748962|NCT04868825|Device|Ivory Dentin Graft|Ivory Dentin Graft is a bone graft material for the repair or augmentation of bone defects in dental procedures. It consists of sterile 300 - 900 μm porous particles or granules of hydroxyapatite and collagen which retain the natural form of the source porcine dentin and protein matrix. (Packed Vial: 1.00 gr; Packed Syringe: 1.0 gr)
15748963|NCT04868825|Device|OsteoBiol Gen-Os|Comparator control device A natural porcine origin cortico-cancellous heterologous bone mix consists of sterile 250 - 1000 μm porous particles of hydroxyapatite and collagen (Packed Vial: 1.0 gr)
15748964|NCT04868812|Device|SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Florence, Italy|SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Florence, Italy; MonaLisa Touch CO2 fractionated laser
15748965|NCT04868799|Biological|Mass spectrometry|Characterization of the proteomic and phosphoproteomic landscape using mass spectrometry
15748966|NCT04868786|Drug|Mycophenolate Mofetil|Administer 15-20mg/kg of mycophenolate mofetil twice daily. Blood sampling for pharmacokinetics(PK) of mycophenolate mofetil will be performed in all patients who have taken the investigational drug for at least 3 days.
15748967|NCT04868773|Drug|Cabozantinib|Oral cabozantinib
15748968|NCT04868773|Drug|TAS-102|Oral TAS-102 (trifluridine and tipiracil)
15748969|NCT04868760|Drug|Ipilimumab|Drug: Ipilimumab 0.1 mg/kg and 0.3 mg/kg in preparatory experiments and 0.3 mg/kg in formal experiment.
15748970|NCT04868760|Drug|IBI310|Drug: IBI310 0.1 mg/kg and 0.3 mg/kg in preparatory experiments and 0.3 mg/kg in formal experiment.
15748971|NCT04868747|Drug|Lidocaine|The participants receive perioperative lidocaine infusion with general anesthesia for gastrectomy.
15748972|NCT04868747|Drug|normal saline|The participants receive perioperative normal slaine infusion with general anesthesia for gastrectomy.
15748976|NCT04868708|Biological|Bevacizumab|Subjects will receive Bevacizumab intravenously.
15748977|NCT04868708|Drug|Paclitaxel|Subjects will receive Paclitaxel intravenously.
15748978|NCT04868708|Drug|Cisplatin or Carboplatin|Subjects will receive Cisplatin or Carboplatin intravenously.
15748979|NCT04868695|Procedure|1) Fronto-Sphenoethmoidektomie 2) Draf 2b 3) Draf 3|1) Fronto-Sphenoethmoidektomie 2) Draf 2b 3) Draf 3
15748982|NCT04868669|Behavioral|In-home, intensive nutrition counseling|"Individualized sessions will be conducted by trained health workers following a standard document (counseling booklet)
~The messages to be provided through the counseling will be contextualized
~Sessions will start from the early second trimester and repeat monthly until 36 weeks of gestation
~Counseling sessions will be conducted at the participant's place
~Sessions will involve influential family members such as the husband, mother-in-law, mother, and the household head along with the pregnant women
~Women will receive personalized feedback on their dietary intake pattern (dietary diversity) and the rate of weight gain in each session
~Sessions will be tailored according to each participant's need and progress"
15748983|NCT04868656|Other|Implementation Strategy: Foundational REP|The goal is to test implementation intensification approaches for STRIDE sites that have not met implementation adoption benchmarks, specifically Foundational REP vs. Enhanced REP. We propose that low intensity implementation support that promotes adapting STRIDE for context and provides tools for ongoing STRIDE evaluation (defined as foundational REP), will be sufficient for some but not all sites to successfully incorporate STRIDE into routine practice.
15748984|NCT04868656|Other|Implementation Strategy: Enhanced REP|The goal is to test implementation intensification approaches for STRIDE sites that have not met implementation adoption benchmarks, specifically Foundational REP vs. Enhanced REP. We posit that monitoring sites' progress and adding, for sites with low adoption, higher intensity strategies (defined as Enhanced REP) that directly influence teams' capacity and skills to effectively self-organize and problem-solve will lead to higher implementation adoption, penetration, fidelity, and value.
15748985|NCT04868643|Device|The DIMI Renal Replacement Therapy (RRT) System|To demonstrate that the safety and efficacy of the DIMI RRT remains consistent when used In-Center by trained dialysis nurses versus in an In-Home environment by trained Care Partners and Subjects.
15748986|NCT04868630|Device|Pulsewave Health Monitor (PAD-2A) Device|This is an observational study of the average breathing rate measurement of a non-invasive wrist cuff device. The purpose of this study is to calibrate the average breathing rate measurement of the Pulsewave Health Monitor (PAD-2A) wrist cuff device with the breathing rate measurement of a standard clinical capnography device. Additionally, we will also compare the average breathing rate measurement of the capnography device with other standard clinical respiratory devices (i.e. nasal pressure transducer, thermistor, and respiratory inductance plethysmography (RIP) belts of the chest and abdomen).
15748987|NCT04868617|Device|ATTRACT-I|The aim of this investigation is to evaluate the performance and safety of an ostomy baseplate with a novel skin protection technology and its ability to reduce peristomal skin complications compared to SenSura® Mio. The subject will be randomized to either test product or comparator at enrollment. The subject will wear the test product for approximately 35 days and then cross-over to the comparator (or vice-versa) for approximately 35 days. At each baseplate change, the subject will answer questions about their skin, and take pictures of their stoma and used baseplate. They will also answer quality of life questionnaires at each study visit.
15748988|NCT04868604|Drug|64Cu-SAR-bisPSMA|64Cu-SAR-bisPSMA
15748989|NCT04868604|Drug|67Cu-SAR-bisPSMA|67Cu-SAR-bisPSMA
15748990|NCT04868591|Other|Single session of education and exercise provided by an advanced practice physiotherapist.|In a one-hour consultation, the APPT will assess and triage surgical candidates, recommend medical care (medication or injection), as well as provide education and prescribe a self-management exercise program aimed at impairments and functional limitations identified during the initial assessment. Participant will not receive additional care by the APPT.
15748991|NCT04868591|Other|Multiple session of education and exercise provided by an advanced practice physiotherapist.|In a one-hour consultation, the APPT will assess and triage surgical candidates, recommend medical care (medication or injection), as well as provide education and prescribe a self-management exercise program aimed at impairments and functional limitations identified during the initial assessment. Participants will receive five additional consultations with the APPT within a 12-week period. During the follow-up visits, the APPT will reassess the participants, provide further education and recommendations, review and modify the home exercise program and may provide other rehabilitation interventions.
15748992|NCT04868578|Drug|study treatment PPI|patient take PPI every day and Etidronate placebo only 2 weeks every 12 weeks
15748993|NCT04868578|Drug|Study comparator ETI|patient take PPI placebo every day ans Etidronate only 2 weeks every 12 weeks
15748994|NCT04868565|Drug|Caffeine Citrate 20 MG/1 ML Intravenous Solution [CAFCIT]|"after randomization, caffeine citrate will be contineously prescribed to those patients assigned to the ongoing caffeine with oxygen supplement (group 2) with a medication regimen of 10mg/kg.dose, once daily, and weekly adjustment based on the working weight."
15748995|NCT04868552|Other|Pre-hospital naloxone education|a 5-10 minute pre-hospital education module teaching patients and support persons how and when to administer naloxone
15748996|NCT04868539|Other|Artificial Light At Night|90 lux lighting for 19hr/day
15748997|NCT04868539|Behavioral|Sleep Restriction|5-hr of sleep/night
15748998|NCT04868526|Behavioral|dietary intervention|manipulate feeding-fasting cycle to be aligned or misaligned with the circadian system
15748999|NCT04868513|Drug|Pregnant women to whom applied silane fluoride|Pregnant women who received 0.1% silane fluoride applied as varnish in the teeth.
15749000|NCT04868513|Drug|Pregnant women to whom applied silane fluoride + 1% chlorhexidine|Pregnant women who received silane fluoride + 1% chlorhexidine applied as varnish in the teeth.
15749001|NCT04868500|Device|AMAZE™ Disease Management Platform|The disease management platform includes a patient mobile application where patients can enter daily symptoms, communicate with their healthcare providers, and access educational materials. Additionally, the healthcare providers will have access to a dashboard that is integrated with the EMR and patient app.
15749509|NCT04864340|Procedure|Comparator|Non-nociceptive procedure (fine touch)
15749002|NCT04868487|Other|Health Literacy Education|Health literacy education, consisting of four sessions, was given to the intervention group.
15749003|NCT04868474|Behavioral|Training program and decision aid|1) a one-time, in-person, 2.5-hour training program encouraging participating GPs to present quitting smoking with a quit aid as the default choice to their eligible patients, and 2) access to an electronic decision aid that presents available quit aids. The 2.5-hour training program consists of: 1.5 hours of didactic teaching, with information about pharmacologic quit aids, electronic cigarettes, presenting quitting as a default choice, the decision aid, and a video of a model consultation. This is followed by 1 hour of role plays to practice presenting quitting as a default choice using the decision aid.
15749004|NCT04868474|Behavioral|Refresher course|A 45-minute refresher training about smoking cessation that does not aim to change GP behaviour. It will include the same information about pharmacologic quit aids and electronic cigarettes.
15749005|NCT04868461|Dietary Supplement|Unheated Whey Protein (UWP) beverage|The preload is made from whey protein powder. The energy load of the preload is 119.7 kcal and has banana flavor and sweetener.
15749006|NCT04868461|Dietary Supplement|Heated Whey Protein (HWP) beverage|The preload is made from whey protein powder of 95% and it is heated for a certain amount of time. The energy load of the preload is 119.7 kcal and has banana flavor and sweetener.
15749007|NCT04868461|Dietary Supplement|Casein (Cas) beverage|The preload is made from casein powder. The energy load of the preload is 105 kcal and has banana flavor and sweetener.
15749008|NCT04868461|Dietary Supplement|Water|The preload is water acting as a control and contain the same banana flavor and sweetener to match the other three intervention - protein beverages.
15749009|NCT04868448|Biological|Covid-19 vaccines|Observation of individuals who received one or more doses of covid-19 vaccines.
15749010|NCT04868422|Device|Telemonitoring via wireless internet-based system|
15749011|NCT04868409|Drug|Suxamethonium|1 mg/kg for tracheal intubation after 60 seconds
15749012|NCT04868409|Drug|Rocuronium|1 mg/kg for tracheal intubation after 60 seconds
15749013|NCT04868396|Procedure|Tumor biopsy|Tumor material will be derived from 'left-over' tumor tissue that is not needed for standardised diagnostics (immune histochemistry and molecular testing).
15749014|NCT04868383|Behavioral|Use of smart phone technology to support medication adherence and uptake|Use of smart phone technology to support medication adherence and uptake
15749015|NCT04868370|Other|Assessment of the upper limb (VPIT + PPIT)|Assessment of the upper limb sensorimotor function (VPIT and PPIT)
15749016|NCT04868357|Behavioral|Hypnosis|Two 45-minute group sessions in which patients experience hypnosis and learn how to use it for the self-management of anxiety and anxiety-related dyspnea. First session is introductory. Second session addresses concerns that patients may have identified after using self-hypnosis. Both sessions include group hypnosis exercises. Both sessions are to be administered in an identical manner, and require the same motor and communication responses from the patient (i.e., concentrate on the practitioner's voice, eye closure, relaxation, nodding). Patients are asked to concentrate in nature-themed metaphors and hypnotic suggestions of pure air entering their lungs. Both sessions end with a round of questions, instructions and motivation to use self-hypnosis throughout the duration of the PRP and beyond.
15749017|NCT04868357|Behavioral|Relaxation|Two 45-minute group sessions in which patients experience dynamic relaxation and learn how to use it for the self-management of anxiety and anxiety-related dyspnea. Both sessions include group relaxation exercises. Both sessions are to be administered in an identical manner, and require the same motor and communication responses from the patient (i.e., concentrate on the practitioner's voice, stretching, breathing exercises, nodding). Both sessions end with a round of questions, instructions and motivation to use relaxation throughout the duration of the PRP and beyond.
15749018|NCT04868344|Drug|MRG003|Administered intravenously
15749019|NCT04868331|Behavioral|Exercise|Two trials of 7-min High Intensity Interval Training (HIIT) with 12 different exercises. Each exercise lasts for 30 seconds continuously with 10 seconds rest interval.
15749020|NCT04868318|Other|Very-high protein enteral formula|Peptamen® Intense VHP (37% protein)
15749021|NCT04868318|Other|Standard-high protein enteral formula|Peptamen® (16% protein)
15749022|NCT04868305|Procedure|Intramedullary nail|"Intertan nail (Smith & Nephew)* or Gamma 3 nail (Stryker)*
~* All of the above-mentioned products are subjects to change into an equivalent product"
15749023|NCT04868305|Procedure|Hip arthroplasty|"Total hip arthroplasty:
~Cemented: Lubinus (Link)*, Exeter (Stryker)*
~Uncemented: Restoration Modular (Stryker)*
~Cup: Cemented Avantage dual mobility cup (Zimmer Biomet)*
~Hemiarthroplasty:
~Cemented: Lubinus (Link)*, Exeter (Stryker)*
~Uncemented: Restoration Modular (Stryker)*
~All of the above-mentioned products are subjects to change into an equivalent product"
15749025|NCT04868279|Behavioral|Web-Based Interactive Nurse Support Program Based on Health Promotion Model|Nursing education will be given on healthy behaviors such as nutrition, exercise, health responsibility and stress management according to the health promotion model. The researcher will make phone calls with the intervention group for 6 months (12 times in total), twice a month. During telephone interviews, individuals will be talking about the use of the website, the points that are not understood or need to be emphasized, their application of health promotion behaviors, the obstacles they experience during the application and the suggestions for this.
15749026|NCT04868266|Other|end tidal carbon dioxide monitoring|We will monitor end tidal carbon dioxide with capnography during minimal sedation
15749027|NCT04868253|Drug|EMB-01|EMB-001 is a proprietary combination of metyrapone (a cortisol synthesis inhibitor) and oxazepam (a short to medium acting benzodiazepine).
15749028|NCT04868240|Behavioral|Concurrent training program|"The experimental group will perform 16-weeks of exercise. The exercise sessions will occur three times/week.
~The participants should conduct their daily activities as usual outside of the study and maintain the same diet."
15749029|NCT04868227|Dietary Supplement|FULTIUM D3 VITAMIN D3|VITAMIN D3 SUPPLEMENT
15749030|NCT04868214|Device|coagulation measurements|peak and trough coagulation measurements of patients treated with Xarelto, Eliquis, or Lixiana and coagulation measurements of healthy proband blood spiked with eiter Xarelto, Eliquis or Lixiana.
15749031|NCT04868201|Device|0-anxiety|0-anxiety is a self-guided app-based utilizing virtual reality establish in cognitive behavior therapy treatment.
15785277|NCT04570670|Drug|dimethyl fumarate 240 mg|
15749032|NCT04868188|Other|5 blood samples|5 blood samples across 3 occasions/sampling windows (Day 1-4, Day 6-9 and Day 11-14) to determine plasma concentrations of voriconazole
15749033|NCT04868188|Genetic|Determination of CYP2C19 genotype|A single buccal swab to determine the CYP2C19 genotype will be undertaken during the course of ICU stay.
15749034|NCT04868175|Drug|Timolol|Topical eye drops for lowering intraocular pressure Beta blocker to reduce aqueous production
15749035|NCT04868175|Drug|Travatan|Topical eye drops for lowering intraocular pressure Prostaglandin analogue to increase aqueous outflow
15749036|NCT04868175|Drug|Hypromellose|Placebo eye drop, lubricant
15749037|NCT04868162|Drug|MRG003|Administered intravenously
15749038|NCT04868149|Procedure|Associating Liver Partition and Portal Vein Ligation for Staged Hepatectomy (ALPPS)|Surgery procedure
15749039|NCT04868136|Behavioral|Exercise|30 minutes of exercise at 80% of maximum predicted heart rate performed on an indoor stationary bicycle. Exercise was preceded by 10 min of gradually increasing cycling intensity in one of two exercise trials
15749040|NCT04868123|Device|Transcutaneous Nerve Stimulation (TENS)|Transcutaneous nerve stimulation (TENS) is a simple home base treatment to manage pain. It involves electrical current applied to the skin through self-adhering electrodes, using a TENS3000 device (TENSPros.com).
15749041|NCT04868123|Behavioral|Mindfulness Meditation|Mindfulness mediation is a guided mediation process to improve awareness of being present in the moment.
15749042|NCT04868110|Behavioral|High fiber diet|A registered dietitian will delivered the lessons on consuming a high fiber diet to small groups to increased engage and material retention. These lessons will last 18 weeks.
15749043|NCT04868097|Procedure|cervix biopsy|large loop electrosurgical cervix biopsy
15749044|NCT04868084|Behavioral|Physical literacy in the early years|Intervention nurseries received a 6-hour training session, covering the theory about FMS and practical demonstrations of age-appropriate ways to teach and develop FMS.
15749045|NCT04868071|Behavioral|Physical Exercise|Exercise interventions were carried out over a total of 16 weeks in the mornings (08:00 am-12:00 am) under the supervision of at least two fitness instructors. Participants performed four exercises for lower limbs (Figure 9): 1st) squat on the chair, 2nd) seated unilateral hip flexion, 3rd) seated unilateral knee extension, and 4th) bilateral calf raise with 12-15 submaximal repetitions avoiding fatigue (i.e., inability to complete a repetition in a full range of motion). The number of sets was increased linearly during the first month, such that one set was performed in the 1st week, two sets in the 2nd week, 3 sets in the 3rd week, and 4 sets in the 4th week. Subsequently, participants performed the main exercise period. After a brief warm-up, participants performed the same exercises that were performed during the familiarization period using an adjustable weight vest and ankle weights (DOMYOS®, Shangai, China).
15749046|NCT04868058|Drug|Ropivacaine injection|Ropivacaine : 0.4 ml/kg (ideal body weight!) of 5mg/ml (20 to 30 ml bolus dose (100-150 mg), maximum dose 200 mg ropivacaine
15749047|NCT04868045|Drug|Thyrotropin Releasing Hormone (TRH)|TRH administration will be given as a 200-mcg single IV bolus on Day 1 and Day 5.
15749048|NCT04868045|Drug|levothyroxine|"Patients maintenance dose of levothyroxine will be taken throughout the study. On Day
~1 and Day 5, the levothyroxine will be taken after the TRH test is complete. On Days 2- 4, the levothyroxine will be taken in the morning."
15749049|NCT04868045|Other|Hypothyroidism QOL questionnaire|Administer standardized Hypothyroidism QOL questionnaire.
15749050|NCT04868032|Behavioral|Positive Psychology-Motivational Interviewing|Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
15749051|NCT04868032|Behavioral|Enhanced Usual Care Control|Participants randomized to this condition will be provided with a Fitbit, but will not receive any intervention phone calls or the written manual.
15749052|NCT04868019|Drug|Fenofibrate Capsules|Solutions will be prepared in the required strengths and labeled accordingly. Group A will receive Solution A i.e. Fenofibrate suspension is prepared by dissolving 200 mg capsule in 10 ml distilled water and given as a single dose of 10mg/kg (0.5 ml/kg) and Group B will receive solution B i.e. 0.5ml/ kg normal saline as a placebo. Both groups will receive LED phototherapy under standard conditions. The serum bilirubin level will be noted at the time of admission and then at 12hr, 24hr, and 48 hours of treatment
15749053|NCT04868006|Procedure|End-range Maitland mobilization + proprioception training|End-range Maitland mobilization performed in end position of internal rotation of the shoulder accompanied with 8--week long proprioception training
15749054|NCT04868006|Procedure|Non end-range Maitland mobilization + proprioception training|Non end-range Maitland mobilization performed in loose position of the shoulder accompanied with 8--week long proprioception training
15749055|NCT04868006|Procedure|Sham manual therapy technique + proprioception training|Placebo performed in loose position of the shoulder accompanied with 8--week long proprioception training
15749056|NCT04867993|Drug|Amikacin|15 mg/kg/36h
15749057|NCT04867980|Drug|ACP-196|Participants will receive a single oral dose of 100 mg ACP-196 (1 x 100 mg capsule) on Day 1 (Treatment A) and 400 mg ACP-196 (4 x 100 mg capsules) on Day 1 (Treatment B) according to the randomization scheme.
15749058|NCT04867980|Drug|Moxifloxacin 400 mg|Participants will receive a single oral dose of 400 mg moxifloxacin (1 x 400 mg tablet) on Day 1 (Treatment C) according to the randomization scheme.
15749059|NCT04867980|Drug|Placebo|Participants will receive a single oral dose of ACP-196 matching placebo (4 x 100 mg matching placebo capsules) and moxifloxacin matching placebo (1 x 400 mg matching placebo tablet) on Day 1 (Treatment D) according to the randomization scheme.
15749060|NCT04867967|Behavioral|Iyengar Yoga|Classical Iyengar Yoga intervention, especially designed for headache patients. Note: First administered face-to-face, due to Covid-restrictions changed to online classes
15749061|NCT04867967|Behavioral|Mindfulness-based stress reduction|Standardazied Mindfulness-based stress reduction intervention Note: First administered face-to-face, due to Covid-restrictions changed to online classes
15749107|NCT04867642|Other|Placebo|Study participants will receive placebo comparator in a pre-specified sequence during the Treatment Period of Part A, B and C.
15785566|NCT04568395|Other|sham control|Use a sham control (empty ECIG)
15749062|NCT04867954|Other|Ensure Plus®|In-between two MRI exams, patients will ingest a standardized meal of two cans (16oz) of Ensure Plus® (Abbott Laboratories), providing a 700cal meal (13g protein, 11g fat, 50g carbohydrates), proven to elicit a strong hyperemic splanchnic response.
15749063|NCT04867954|Other|Pre-clinical validation contrast enhanced MRI|Participants will be asked to complete a single research visit that will include a contrast enhanced MRI scan lasting up to 1 hour. Participants will be screened a final time for contraindications to contrast enhanced MR imaging; an IV will be placed; and participants will be positioned in the MR scanner, asked to lie as still as possible and to follow some breath hold instructions.
15749064|NCT04867954|Other|Clinical validation MRI|"Participants will be screened for any previous reactions to Ferumoxytol or GBCAs and dosing will be consistent with standard of care.
~Participants will then undergo a research MRI lasting approximately 1.5 hours.
~All participants will be positioned in the MRI scanner for the initial scanning session (30 min) during which a 3/4 of the full dose of gadolinium based contrast agent (GBCA) or the total dose of Ferumoxytol will be administered.
~The first 50 participants will be removed from the scanner bore, repositioned, and scanned for an additional 15 minutes (repeatability testing).
~All participants will then be removed from the scanner and asked to consume 16 ounces of Ensure Plus®. After 20 minutes, they will be repositioned in the scanner for an additional scanning session (15 minutes) during which, the remaining 1/4 dose of GBCA will be administered, if required."
15749065|NCT04867941|Drug|ACP-196|All study participants will receive a single oral dose of 50 mg ACP-196 (2 x 25 mg capsules) on Day 1 of the study.
15749066|NCT04867928|Drug|Venetoclax+azacitidine|subjects will receive venetoclax 400 mg orally QD on Days 1 - 28 plus azacitidine 75 mg/m2 SC or IV daily for 7 days. Cycle Length - 28 Days. . Subjects will continue treatment until subsequent alloSCT.
15749067|NCT04867902|Behavioral|Positive Psychology-Motivational Interviewing Intervention|Participants will receive a written treatment manual with detailed information about each topic. The intervention consists of 10 weekly phone sessions (30 minutes each). Each session includes a new psychological skill designed to increase positive emotions experienced during physical activity, a motivational skill designed to boost physical activity, and setting a physical activity goal for the next week using information from the Fitbit. A motivational interviewing approach will be used for all topics.
15749068|NCT04867889|Device|iTBS (intermittent theta-burst stimulation)|"The iTBS treatment is a type of rTMS (repetitive transcranial magnetic stimulation), delivered with MagPro X100 stimulator and a Cool-B65 A/P coil or a conventional cool-B65 coil.
~The iTBS treatment is applied to over the dorsolateral prefrontal cortex using a standardized measuring of the anatomical landmark F3 from the 10-20 positioning system. The coil is positioned with the handle at in a 45 degree angle from the midline. The non-shielded side of the cool-B65 A/P coil is placed towards the patient, or if using the cool-B65 coil the centre of the butterfly is placed towards the patient head"
15749069|NCT04867889|Device|Sham iTBS|"The sham iTBS is delivered with MagPro X100 stimulator and a Cool-B65 A/P coil.
~The coil is placed over the dorsolateral prefrontal cortex using a standardized measuring of the anatomical landmark F3 from the 10-20 positioning system. The coil is positioned with the handle at in a 45 degree angle from the midline. For all patients electrodes for transcutaneous electrical nerve stimulation (TENS) are applied and if the patient is randomized to sham treatment the shielded side of the coil will be pointing towards the patient's head and there will be a weak TENS current applied instead synchoronously. If the cool-B65 is used the coil is instead angled 90 degrees delivering the pulses into air instead"
15749070|NCT04867876|Behavioral|Physical Therapy|Management of urinary incontinence by a physical therapist will include but is not limited to biofeedback, dietary management, alleviation of constipation, and neuromuscular re-education.
15749071|NCT04867850|Other|Usual Care|Individual clinicians will receive an automated weekly email detailing a weekly roster of their upcoming repeat-patient visits (Index Visit) with patients at high risk of 6-month mortality as determined by a validated machine learning prognostic algorithm. Clinicians will receive a HIPAA compliant text message on the morning of the appointment reminding them to consider a serious illness conversation with patients on the list.
15749072|NCT04867850|Other|Clinician Nudge|Clinicians will receive the usual care weekly email and text message described above under Usual Care. In addition, embedded in the weekly email, clinicians will receive performance feedback information detailing their documented SICs relative to those documented by peers.
15749073|NCT04867850|Other|Patient Nudge|Ahead of the Index Visit, high risk patients as identified by the prognostic algorithm will receive a nudge via personal text message and email consisting of a normalizing message prompting patients with a personalized link to a short electronic questionnaire on SIC topics.
15749074|NCT04867837|Drug|Octaplex|Four-factor prothrombin complex concentrate (4F-PCC)
15749075|NCT04867824|Dietary Supplement|Case (use of inhaled vanilla essential oil)|Use of inhaled vanilla essential oil during frenotomy for a tongue-tie
15749076|NCT04867824|Dietary Supplement|Control (use of inhaled lavender essential oil)|Use of inhaled lavender essential oil during frenotomy for a tongue-tie
15749077|NCT04867811|Other|conventional therapy|conventional therapy
15749078|NCT04867811|Other|cupping therapy|cupping therapy
15749079|NCT04867811|Device|TENS|transcutaneous electrical nerve stimulation
15749080|NCT04867811|Other|TENS and cupping therapy|TENS and cupping therapy
15749081|NCT04867798|Drug|Lamivudine-Tenofovir 300 Mg-300 Mg Oral Tablet|PrEP eligible participants will be asked to follow up monthly for 12 months. PrEP will be prescribed for once-daily use and discontinued if HIV tests are positive. At quarterly visits, participants will receive Integrated Next Steps Counseling (iNSC) for PrEP adherence with point-of-care drug level feedback. Participants will receive iNSC Support Level 1 to address PrEP adherence and sexual health needs. Those with urine tenofovir levels <1500 ng/mL will receive iNSC Support Level 2, in which participant responses to two 7-item questionnaires on PrEP adherence and sexual health will guide problem solving on improved dosing. Medication refills will consist of 3-month supplies.
15749085|NCT04867772|Other|Home based rehabilitation|
15749108|NCT04867629|Dietary Supplement|Rapeseed oil|20mL of rapeseed oil to be consumed daily in replacement to habitual oil
15749109|NCT04867629|Dietary Supplement|Sunflower oil|20mL of sunflower oil to be consumed daily in replacement to habitual oil
15749086|NCT04867759|Procedure|Endometrial Biopsy|On outpatient basis, we will take a uterine sample on mid-luteal phase day 21 by Novac curette or pipelle aspirator. Samples of endometrium will be kept in formaline solution and will be sent to National Institute of research and medical sceinces at Alexandria University to be tested for uNK Cells CD56.
15749087|NCT04867746|Other|data collection by health questionnaires|Health questionnaires to assess scores concerning pain and function of the treated leg and overall health
15749088|NCT04867746|Other|assessment of muscle strength|Muscle strength will be measured bilaterally using a dynamometer (Biodex System 4 Pro: Biodex Medical Systems, Shirley, NY, USA). For the knee, maximum isokinetic flexion and extension torques will be collected between full extension and full flexion at a movement speed of 60°/s (5 repetitions) and 240°/s (15 repetitions). Maximum joint torques in each movement direction will be recorded for each joint and normalized to body weight.
15749089|NCT04867746|Other|assessment of gait|Instrumented gait analysis on a treadmill with an embedded plantar pressure plate (h/p/cosmos, Zebris FDM-T, Isny, Germany; 7168 sensors; area, 1.5 * 0.5 m; range, 1-120 N/cm2; precision, 1-120 N/cm2 ± 5%; sampling rate, 120 Hz) and on an overground walkway with two embedded force plates (Kistler force plate 9260AA6, Kistler AG, Winterthur, Switzerland; sampling rate 2400 Hz). Simultaneously with the plantar pressure or force data, kinematic and electromyographic (EMG) data will be collected. Participants will then walk for 1 minute at their preferred walking speed (0% slope and at 15% slope) and at 1.2 m/s (0% slope). For all conditions, kinematic, EMG and pressure data will be recorded for 1 minute. Subsequently, the treadmill speed will be increased to preferred running speed and 2.3 m/s (0% slope), and data for 1 minute running will be recorded. Subjects will then complete overground walking and running trials on the walkway with embedded force plates.
15749090|NCT04867746|Other|assessment of squatting and single leg hops|Participants perform three jumps on a force plate. Maximum jump length, Maximum flexion and extension angles and joint moments will be identified. Subsequently, participants perform three squats onto two force plates (one per foot). On- and off times will be computed for each muscle and condition.
15749091|NCT04867746|Other|assessment of postural stability|The length of the centre of pressure path will be measured during two 30-second unipedal stance trials using a force plate.
15749092|NCT04867733|Other|Micropatch (microneedle patch)|Each micropatch contains an array of 50 microneedles.
15749093|NCT04867720|Drug|Everolimus|- Oral intake, BID - After first dose 1mg(total 2mg daily), check the blood concentration of everolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 3~8mg/mL.
15749094|NCT04867707|Drug|Zanamivir|5 days of treatment with 10mg zanamivir inhaler BID
15749095|NCT04867694|Behavioral|BCC|Behavior change communication on Nutrition, Health & Hygiene, including (but not limited to) awareness of dietary diversification from 6 months of age and adequate complementary feeding; and raising awareness of good water and hygiene practices.
15749096|NCT04867694|Dietary Supplement|Preventive supplement|Monthly delivery of a nutritional supplement: enriched flour (CSB++), at a dose of 3 kg/month/beneficiary child. The nutritional supplement is limited to [6-11] months old children diagnosed as non-wasted (green MUAC); or children [12-59] months old for 6 months after discharge from a CMAM treatment or consolidation program.
15749097|NCT04867694|Dietary Supplement|MNP|Delivery of micronutrient powders to [12-23] months old children (30 sachets per month for 2 months, every 6 months, according to international recommendations).
15749098|NCT04867694|Other|Water purification input|Monthly delivery of a water purification input: bleach or flocculant/decontamination sachets for the potabilization of the water of the whole household. The water treatment input is limited to households with [6-11] months old children, or children [12-59] months old enrolled in a CMAM treatment program and for 6 months after discharge.
15749099|NCT04867694|Behavioral|Family MUAC|"One-time delivery of a mid-upper arm circumference (MUAC) measuring tape and training of families in its use, and actions to be taken based on the results. This will involve distributing Shakir bands to all households with [6-59] months old children and training mothers/guardians, or any other family members who express an interest, in screening for wasting using the MUAC criteria, and explaining the procedure to follow if the child tests positive in the family.
~Formative supervision of MUAC measurement in families. The training will be carried out by the members of the care groups and at each home visit, they will be able to ensure that the MUAC measurement technique is well mastered by the mother (or another member) and correct the technique if necessary."
15749100|NCT04867694|Behavioral|Screening by care group|"Monthly screening by the care group volunteers of the children they follow, using the MUAC.
~Referral to the health center of [6-59] months old children screened as malnourished (result of MUAC orange or red), and follow-up on referral to confirm child was enrolled"
15749101|NCT04867694|Behavioral|CMAM compliance|"Weekly follow-up of [6-59] months old children under treatment and for 6 months after discharge from the national treatment and consolidation program : care group volunteers follow children under treatment until they recover and for the whole duration of their consolidation (for children cured of severe emaciation) through weekly home visits.
~They monitor treatment adherence (i.e., families follow the planned schedule of visits and receive inputs for treatment or consolidation) and treatment compliance (i.e., the malnourished or consolidating child receives the planned dose of therapeutic or supplementary food each day)."
15749102|NCT04867681|Behavioral|Psycho-education programme|4 individual sessions (S1, S2, S3, S4) of one hour each spread over 2 weeks, i.e. 2 sessions per week. S1 explains the different clinical signs and discusses the prognosis of the disease, S2 deals with the question of drug treatments, their different forms and their mechanisms of action. S3 discusses the evolution of the disease and the organisation of the care pathway. Finally, S4 looks at the aspects of quality of life, lifestyle and the fight against addictive co-morbidities, and concludes with a review of the patient's motivation and involvement in the subjects covered.
15749103|NCT04867668|Behavioral|Anti-vaping and anti-smoking digital advertising|Delivery of social media based advertising to prevent vaping and smoking among young adults ages 18-24.
15749104|NCT04867655|Other|Orange Juice|Approximately 500 ml of orange juice will be consumed and then blood and urine samples will be collected for 24 hours
15749105|NCT04867655|Other|Orange juice with either 6g or 3 g of β-Glucan|Approximately 500 ml of orange juice mixed with either 6g or 3 g of β-Glucan will be consumed and then blood and urine samples will be collected for 24 hours
15749106|NCT04867642|Drug|UCB0022|Study participants will receive doses of UCB0022 in a pre-specified sequence during the Treatment Period of Part A, B and C.
15749110|NCT04867616|Other|Placebo|"Pharmaceutical form: Solution for infusion
~Route of administration: Intravenous infusion
~Participants will receive Placebo during the Double-blind Treatment Period."
15749111|NCT04867616|Biological|Bepranemab|"Pharmaceutical form: Solution for infusion
~Route of administration: Intravenous infusion
~Participants will receive pre-specified doses of bepranemab during the Double-blind Treatment Period and the Open-label Extension Period."
15749112|NCT04867603|Drug|[Ga-68]PSMA|The injectable activity will be a maximum of 210 MBq (6.0 mCi) [Ga-68]PSMA at the time of injection and is administered to subjects by intravenous injection.
15749113|NCT04867603|Device|PET/CT imaging|PET/CT imaging procedure
15749114|NCT04867590|Device|Endorotor|"The treatment itself is preceded by a sub-mucosa saline and adrenalin solution injection administered by an endoscopic sclerotherapy needle lifting the submucosa and thus reducing the risk of perforation and hemorrhage.
~The interventional tool is then applied tangentially to be brought into contact with the lifted mucosa, visual monitored by endoscope. The aspiration and sectioning system is activated by use of a pedal and a generator specially made for the system, used in every procedure. The entire surface area of the targeted mucosa must be covered by the probe. The residual tissue is then removed via the aspiration system and caught by a filter. The specimens are then easily retrievable at the end of the procedure and can be stored in formalin fixing solution for histological analysis."
15749115|NCT04867590|Device|Radiofrequency|"Endoscopic treatment using the HALO® 360 or 90 system is a thermal method for destroying the superficial mucosa. An initial debridement of the mucosal deposits is carried out by application of acetylcysteine in spray form with a spray catheter on the entire mucosal surface to be treated and then rinsed with water after a minute of application time.
~For circumferential BEs, a single-use 360 Express® probe is used to make it possible to size the diameter of the esophagus and the treatment used. The length of the treatment area is 5 cm and several points of impact can be achieved by overlapping the catheter at two consecutive heights, with the zone spanned measuring one centimeter, in order to cover the entire pathological area requiring treatment.
~For non-circumferential lesions a palette applicator is used in a variety of sizes, and in this context no sizing of the esophagus is required."
15749116|NCT04867577|Diagnostic Test|CT scan of lung and spine|Dual energy CT scan of thorax and spine
15749117|NCT04867564|Diagnostic Test|Echocardiography|Traditional echocardiography and speckle tracking echocardiography (STE) before and 1, 6, and 12 months after RT
15749118|NCT04867551|Drug|KDT-3594|oral administration, dose titration
15749119|NCT04867538|Other|no intervention|No intervention
15749120|NCT04867525|Other|Physician's choice according to patient's needs.|Routine care as per site standard.
15749121|NCT04867512|Dietary Supplement|Liquid Tincture|Biocidin Liquid Tincture: 1 drop by mouth twice daily, increased by one drop each day until 15 drops twice daily have been reached. 15 drops by mouth twice daily will be maintained through the duration of the study.
15749122|NCT04867512|Dietary Supplement|GI Detox|GI Detox: 2 capsules by mouth every evening and 1 hour away from all food maintained through the duration of the study.
15749123|NCT04867512|Dietary Supplement|Olivirex|Olivirex: 2 capsules by mouth twice daily taken with Biocidin liquid tincture starting at week 10 until week 14 of the study for non-responders determined by symptoms and lactulose breath test results.
15749124|NCT04867499|Other|No intervention|Descriptive study. No intervention.
15749125|NCT04867473|Behavioral|Teleyoga|12 weekly 75 minute therapist-led teleyoga sessions
15749126|NCT04867460|Procedure|Ultrasound guided venous access|Access of the axillary vein using ultrasound guidance.
15749127|NCT04867447|Diagnostic Test|Psychological trauma evaluation|"Psychological trauma exposure is assessed by validated scales:
~Childhood Trauma Questionnaire (CTQ)
~Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
~Cumulative Trauma Scale.
~The Holmes and Rahe Stress Scale.
~Other clinical scales used:
~Positive and Negative Syndrome Scale (PANSS).
~Dissociative Experiences Scale (DES)
~Mini-Mental State Examination (MMSE)."
15749128|NCT04867434|Drug|RZL-012|small synthetic molecule for submental fat reduction
15749129|NCT04867434|Drug|Placebo|Placebo
15749130|NCT04867421|Other|No intervention|No intervention
15749131|NCT04867395|Behavioral|HELPix Care Plan|"A web application tool for CMC - Health literacy-informed, disease and medication-specific, standardized discharge instructions that will: 1) facilitate plain language provider/parent communication at hospital discharge and 2) act as stand-alone handouts that parents can use at home."
15749132|NCT04867382|Behavioral|Online training|This intervention consists of two different interactive online trainings that are delivered through an online learning platform at HealthPartners.
15749133|NCT04867369|Drug|Pecs II block|Patients will receive an interscalene nerve block with 15 mL 0.5% bupivacaine + a Pecs II fascial plane block with 20 mL 0.25% bupivacaine
15749134|NCT04867369|Drug|Surgical infiltration|Patients will receive an interscalene nerve block with 20 mL 0.5% bupivacaine + local infiltration of 0.25% bupivacaine by the surgeon, up to 15 mL
15749135|NCT04867356|Other|Spinal Stabilization Exercises (SSE)|"Spinal stabilization exercises (SSE) including bridging, planks and tummy tuck-in will be performed. Each participant received a total 7 session thrice a week sessions in two weeks, . Each session had lasted for 30-40 minutes. Spinal stabilization exercises were repeated 5-15 times depending on the endurance of patients.
~Home exercise plan will also be given e.g. postural care, precautions in lifting and carrying weights etc."
15749136|NCT04867356|Other|Spinal Stabilization Exercises (SSE) & Latissimus Dorsi Stretching (LDS)|In experimental group in addition SSE group interventions, participants will receive the latissimus dorsi stretching (LDS). Each participant received a total 7 session thrice a week sessions in two weeks. Each session had lasted for 30-40 minutes. each stretch of latissimus dorsi was of 20-30 seconds with 10-20 repetitions in each session.
15749137|NCT04867343|Drug|HR020602 injection|HR020602 injection
15749138|NCT04867343|Drug|fentanyl injection ； remifentanil injection|fentanyl injection + remifentanil injection
15749139|NCT04867330|Other|Toxicities reduced treatment arm|Two cycles Toripalimab+docetaxel+cisplatin induction chemotherapy followed by reducing radiation dose(60Gy/30Fx) and omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR)
15749213|NCT04866771|Other|Sham tDCS + anodal tDCS|Fake noninvasive brain stimulation or anodal noninvasive brain stimulation
15749391|NCT04865354|Device|Verofilcon A contact lenses|Spherical soft contact lenses for daily disposable wear
15749140|NCT04867317|Drug|Somatropin|Participants (n=172) will be randomized in a 1:1 ratio to rhGH (n=86) versus placebo (n=86) for six months, stratified by participating site. Both study participants and the study team will be blinded to treatment assignment. All participants will complete in-clinic follow-ups at Days 14, 40, 65, and 90 (3 months) and at day 180 (6 months). The primary outcome will be the mean difference in QoL-AGHDA scores between treatment arms at 6 months follow-up. Patients will discontinue the study intervention at 6 months, and will be followed-up two weeks subsequent, in order to assure patient safety and wellness, and to ensure maximal facilitation of patient transition back into routine care.
15749141|NCT04867317|Other|Placebo|Participants (n=172) will be randomized in a 1:1 ratio to rhGH (n=86) versus placebo (n=86) for six months, stratified by participating site. Both study participants and the study team will be blinded to treatment assignment. All participants will complete in-clinic follow-ups at Days 14, 40, 65, and 90 (3 months) and at day 180 (6 months). The primary outcome will be the mean difference in QoL-AGHDA scores between treatment arms at 6 months follow-up. Patients will discontinue the study intervention at 6 months, and will be followed-up two weeks subsequent, in order to assure patient safety and wellness, and to ensure maximal facilitation of patient transition back into routine care.
15749142|NCT04867304|Other|Patient education about chronic pancreatitis.|"Patients in the second cohort were educated about their disease phenotype in a structured and personalised manner that included their disease course, symptoms, imaging, treatment option and possible long-term outcomes and prognosis. This was followed by answering all the queries of the patient and their caregivers.
~The patients were advised to visit the Pancreas clinic after 3-months for re-evaluation of the clinical, psychological and metabolic parameters."
15749143|NCT04867291|Dietary Supplement|Pizza|Portion equivalent to 200 µg of iodine (half a pizza), consumed with ~450mL of water.
15749144|NCT04867291|Dietary Supplement|Seaweed Sheets|Portion equivalent to 200 µg of iodine (~10g), consumed with two slices of white bread and ~450mL of water.
15749145|NCT04867291|Dietary Supplement|Seaweed Powder|Portion equivalent to 200 µg of iodine (1 capsule), consumed with two slices of white bread and ~450mL of water.
15749146|NCT04867291|Dietary Supplement|Potassium iodide|Portion equivalent to 200 µg of iodine (1.3 tablets), consumed with two slices of white bread and ~450mL of water.
15749147|NCT04867278|Procedure|External Beam Radiation (XRT)|Patients that undergo surgical fixation of an acetabular fracture will receive debridement and a single fraction of external beam radiotherapy to the surgical site within 72 hours of surgery.
15749148|NCT04867278|Procedure|Debridement|Gluteus minimus debridement in the OR
15749149|NCT04867265|Procedure|Mout-to-mouth ventilation|we will record the visibility of chest rising
15749150|NCT04867265|Procedure|Mout-to-mouth ventilation with quantitative analysis|we will record the visibility of chest rising, review the ventilation metrics and evaluate each rescue breath in QCPR Skill Reporter
15749151|NCT04867252|Drug|Resveratrol (1000mg twice a day), Myoinositol 1000mg (Twice a day)|51 Patients with PCOS receiving Resveratrol and Myoinositol 1000mg and 1000mg BD daily respectively
15749152|NCT04867252|Drug|Metformin (500 mg Twice a day), Pioglitazone (15 mg Twice a day)|51 Patients with PCOS receiving Metformin and Pioglitazone 500 mg and 15 mg BD daily respectively
15749153|NCT04867239|Other|A two-day education progra|During the camp, the multidisciplinary team provided disease information, lifestyle modification, nutrition, and exercise.
15749154|NCT04867226|Drug|Colchicine 0.5 MG|participant will be given a Colchicine regimen in a dose of 0.5mg twice daily for 14 days or until symptoms subsides,those with low body weight and develop side effect like diarrhea and vomiting dose will be reduced and supportive treatment will be given .
15749155|NCT04867226|Drug|usual care treatment|control group will receive usual care COVID-19 treatment according to Iraqi protocol guideline and will not receive colchicine.
15749156|NCT04867200|Drug|Lixiana(D006)|NOAC(Factor Xa inhibitor)
15749157|NCT04867200|Drug|CKD-344|NOAC(Factor Xa inhibitor)
15749158|NCT04867187|Other|Repetitive transcranial magnetic stimulation (rTMS)|20 minutes of high frequency (20Hz) rTMS.
15749159|NCT04867187|Other|Mirror therapy using virtual reality|active mirror-based therapy
15749160|NCT04867187|Other|Mirror therapy using sham mirror|20 minutes of sham mirror-based therapy
15749161|NCT04867174|Behavioral|Financial incentives|Each of the study arms, including the no message/control arm, will be interacted with different financial incentives (N=5,000)
15749162|NCT04867174|Behavioral|Convenient scheduling link|In addition, study arms will be randomly assigned a convenient link to the county public vaccine appointment scheduling system highlighted for participants (N=5,000).
15749163|NCT04867174|Behavioral|Race concordant|Randomized to a messenger who is race concordant with the participant
15749164|NCT04867174|Behavioral|Gender concordant|Randomized to a messenger who is gender concordant with the participant
15749165|NCT04867161|Diagnostic Test|Inflammatory markers sampling|"Laboratory sampling:
~Haematology: complete blood count, reticulocytes, IFP, PT, aPTT, fibrinogen, D-dimer Biochemical profile: urea, creatinine, bilirubin, ALT, AST, GGT, CK, LD, ferritin, troponin Inflammation markers IL-6, PCT (procalcitonin), CRP (C-reactive protein), PSP (presepsin)
~BALF (bronchoalveolar lavage fluid) processing protocol:
~microbiology: microscopic examination, standard cultivation test
~biochemistry: albumin, total protein
~Pathology: cytology
~PCR:
~a. Multiplex PCR b. SARS-CoV-2 RNA load"
15749166|NCT04867148|Device|Inertial measurement unit sensor-based gait analysis system|Gait analysis was performed on 20-m long corridor to collect gait data on more than 23 strides. The gait protocol was performed with an IMU sensor-based gait analysis system (DynaStab™, JEIOS, South Korea) consisting of a shoe-type data logger (Smart Balance1 SB-1, JEIOS, South Korea) and a data acquisition system (DynaStab-Spotfire1, Tibco Spotfire 7.10). The shoe-type data logger included an IMU sensor (IMU-3000™, InvenSense, USA) that measured tri-axial acceleration (up to ± 6 g) and tri-axial angular 136 velocity (up to ± 500˚ s-1) along three orthogonal axes.12,16 The IMU sensors were installed in both shoe outsoles, and the data were transmitted wirelessly to a data acquisition system via Bluetooth®. Shoe sizes were adapted to each participant, with available sizes ranging from 225 mm to 280 mm. The local coordinate system for the IMU sensors included the 140 anteroposterior, mediolateral, and vertical directions.
15749167|NCT04867135|Drug|Amikacin Sulfate Injection|The dose and frequency of amikacin was defined by each hospital.
15749241|NCT04866485|Drug|HBM4003 and pembrolizumab|Subjects will be treated with HBM4003 and pembrolizumab on Day 1 during each 21-day cycles.
15749168|NCT04867122|Behavioral|Problem-Solving Therapy|Over an approximately 3-week period, family caregivers randomized to the intervention study arm will learn and apply a problem-solving approach based on the ADAPT model, which encourages participants to follow five steps when solving caregiving problems: 1) focus on adopting a positive attitude to problem solving, 2) define the problem and set goals, 3) generate a list of alternative solutions to the problem, 4) predict consequences of the alternative solutions, and 5) try implementing the most promising solution from among the list of alternatives. The intervention will be delivered by a trained interventionist over the course of three structured sessions either face-to-face in the cancer center or via videoconferencing technology, depending on the FCG's preference. Session content will be summarized in an intervention manual, which we will provide to all intervention participants. Sessions will last approximately 45-60 minutes.
15749169|NCT04867122|Other|Attention-matched Control|"Over an approximately 3-week period, family caregivers randomized to the attention control study arm will participate in informal conversations (friendly visits) with a trained member of the research team."
15749170|NCT04867122|Other|In-depth interviews|The subsample of FCGs interviews will consist of discussing potential barriers and facilitators to the adoption of PST in outpatient palliative oncology settings. -The 30 key stakeholders interviews will discuss how the intervention fits into existing clinical practice and institutional values, what might incentivize adoption of the PST intervention, and how the intervention compares to alternative existing or proposed programs.
15749171|NCT04867109|Other|Patients with Post menopausal bleeding|"Any patient presenting post-menopausal bleeding who is to undergo hysteroscopy or hysterectomy will have an additional blood tube taken during her pre-operative blood work-up for the determination of the serum markers HE4 and CA125, after having obtained her non-opposition to participate in the study.
~The blood tube collected for the research will be sent to the biochemistry laboratory of the Nantes University Hospital for a centralized analysis.
~This analysis will be done sequentially and the results will not be transmitted to the investigator.
~At D0, the day of surgery, the operative report will be retrieved as well as the quality of life questionnaires SF12 and PGI-I and the acceptability questionnaire completed before surgery.
~At 1 month after surgery, the anatomopathological results will be retrieved as well as the value of the tumour markers CA125 and HE4."
15749172|NCT04867109|Diagnostic Test|CA125 and HE4 assays|Blood was collected in a standard heparinized vial. Samples were sent to a central laboratory unit (biochemistry laboratory at the Nantes university hospital), centrifuged and plasmas were stored at -20°C until analysis. Plasma CA125 and HE4 concentrations were determined by run in single measurements using an electrochemiluminescence Elecsys immunoassay (ECLIA) on a Roche Diagnostics Cobas 8000® e602 analyser (Roche Diagnostics, Mannheim, Germany).
15749173|NCT04867096|Other|Physical activity|Patients in arm A (interventional) will carry out a physical activity intervention during 3 months. Patients should perform an interval training program on cycle-ergometer during 3 sessions per week.
15749174|NCT04867083|Drug|ARV bitherapie|"Dolutégravir 50mg / Lamivudine 300mg per day
~Dolutégravir 50mg / Rilpivirine 25mg per day
~Darunavir/r 800mg/100mg / Lamivudine 300mg per day"
15749175|NCT04867070|Diagnostic Test|NAS score|Participants will be recorded according to the NAS and W-BAS pain scores
15749176|NCT04867057|Drug|Trichomylin for SAD|Healthy subject meeting eligibility criteria will be randomized to each dose cohort (up to four dose ascending cohorts) to receive either Trichomylin or Placebo. The study drug (Trichomylin or Placebo) will be administered orally as a single dose.
15749177|NCT04867057|Drug|Placebo for SAD|Healthy subject meeting eligibility criteria will be randomized to each dose cohort (up to four dose ascending cohorts) to receive either Trichomylin or Placebo. The study drug (Trichomylin or Placebo) will be administered orally as a single dose.
15749178|NCT04867057|Drug|Trichomylin for MAD|Healthy subject meeting eligibility criteria will be randomized to each dose cohort (up to three cohorts) to receive either Trichomylin or Placebo. The study drug (Trichomylin or Placebo) will be administered orally for total of 9 days of dosing.
15749179|NCT04867057|Drug|Placebo for MAD|Healthy subject meeting eligibility criteria will be randomized to each dose cohort (up to three cohorts) to receive either Trichomylin or Placebo. The study drug (Trichomylin or Placebo) will be administered orally for total of 9 days of dosing.
15749180|NCT04867044|Other|STUDY|One Hundred Fifty woman patients diagnosed with fibromyalgia according to the American College of Rheumatology 2010 diagnostic criteria
15749181|NCT04867044|Other|Control|healthy woman volunteers
15749182|NCT04867031|Dietary Supplement|Milk|One portion of semi-skimmed cow's milk (approx. 450mL), providing ~140µg of iodine.
15749183|NCT04867031|Dietary Supplement|Fish|One portion of cod (approx. 130g), providing ~140µg of iodine.
15749184|NCT04867031|Dietary Supplement|Seaweed|One portion of dried seaweed sheets (approx. 6g), providing ~140µg of iodine.
15749185|NCT04867005|Behavioral|Impact of a training program|Measurement of the effectiveness of a training program based on the skills and knowledge learning on advance care planning. A 10 hours online course was administered to both arms through an online platform; the 6 hours face-to-face course was administered to each primary care team (5) included in this arm. The 6 hours course was split into 2 sessions of 3 hours each.
15749186|NCT04866979|Device|Experimental: Continuous TBS (cTBS)|Application of cTBS. cTBS will be applied to the left dorsolateral prefrontal cortex (left DLPFC). The coil will be placed at the EEG 10-20 International System position of the F3 electrode. Stimulation parameters will be TBS delivery of 600 pulses divided into blocks of 3 pulses at 50 Hz, which are applied at 5 Hz (every 200 ms), with a stimulation intensity equal to 80% of the motor threshold value at rest.
15749187|NCT04866979|Device|Intermittent TBS (iTBS)|Application of iTBS. iTBS will be applied to the left dorsolateral prefrontal cortex (left DLPFC). The coil will be placed at the EEG 10-20 International System position of the F3 electrode. Stimulation parameters will be TBS delivery of of 600 pulses divided into blocks of 3 pulses at 50 Hz, which are applied at 5 Hz (every 200 ms), alternating 2 seconds of stimulation with a pause of 8 seconds, with a stimulation intensity equal to 80% of the motor threshold value at rest.
15749188|NCT04866979|Behavioral|Cognitive training (CT).|Cognitive training (memory rehabilitation via RehaCom computer software) of 25 min. The training will be focused on memory rehabilitation, implementing a face-name association paradigm. The software uses an individualized adaptive methodology based on the participant's performance.
15749392|NCT04865354|Device|Somofilcon A contact lenses|Spherical soft contact lenses for daily disposable wear
15785762|NCT04566874|Device|ALIF|Anterior Lumbar Interbody Fusion
15749189|NCT04866979|Device|Sham Stimulation (shamTBS)|"Sham rTMS (TBS) will be administered by applying a 30mm thick piece of wood or plastic to a real TMS coil during stimulation, and this additional element will be constructed in such a way that it appears to be an integral part of the apparatus such that the patient remains unaware that they are not receiving stimulation (Rossi et al., 2007 ).This 30mm distance is adequate to ensure that the magnetic pulse does not reach the cortex."
15749190|NCT04866966|Behavioral|Shared medical appointments for weight loss|Shared medical appointments providing education and lifestyle change recommendations to promote weight loss in obese patients
15749191|NCT04866953|Other|Blood transfusion|Number of units of blood received within 24 hours of admission
15749192|NCT04866940|Other|Sequences test|the realization of preliminary acquisitions to validate the feasibility of clinical or cognitive research protocols
15749193|NCT04866927|Dietary Supplement|Use of stable isotopic dilution to assess protein digestibility from Faba bean and to evaluate amino acid bioavailability|Each participant will receive a test meal containing 13C labelled spirulina, 2H labelled Fava bean and 13C phenylalanine. The test meal will be divided on 11 subdoses: 3 sub-doses will be administrated at T0 and 1 subdose will be administrated at 1, 2, 3, 4, 5, 6 and 7h. The remaining sub-dose will be kept for measurement of IAA in the test meal. After eating the test meal, blood, urine and breath samples will be collected from each participant at the baseline (T0) and after 5-6, 7h and 8h.
15749194|NCT04866914|Behavioral|Acceptance and Commitment Therapy for Insomnia|ACT-I treatment group: Participants diagnosed with chronic insomnia will receive group treatment. The six sessions will be aimed at psychoeducation about sleep added to the therapeutic processes of acceptance, mindfulness, availability, values, defusion and commitment, used in ACT.
15749195|NCT04866914|Behavioral|Cognitive Behavioral Therapy for Insomnia|Active control group CBT-I: Participants diagnosed with chronic insomnia will receive treatment in a group. The six sessions will be aimed at cognitive-behavioral components, such as education and sleep hygiene, stimulus control, sleep restriction and demystification / restructuring of belief beliefs.
15749196|NCT04866901|Behavioral|Slow-Paced Breathing (SPB)|see arm description
15749197|NCT04866901|Behavioral|Mindfulness (M)|see arm description
15749198|NCT04866901|Behavioral|Yogic Breathing (SPB+M)|see arm description
15749199|NCT04866888|Procedure|closure of the uterine wall defect|Uterine exteriorization followed by pealing of amniotic membranes to reach an accessible pole of the placenta to detect a plan of cleavage behind it. The independent hand of the surgeon passed through the previous plan from points of least resistance to high resistance. The defect will be repaired from the inner aspect of the uterus via running sutures using Vicryl (1-0) on a round needle, 45mm. the suture will pass from one edge to hitch the bed and pass to the other edge till we completely close the defect subsequently, controlling the bleeding. Uterine scar closure by running sutures in two layers, where the first layer compresses the placental bed defect externally.
15749200|NCT04866888|Diagnostic Test|ultrasound|"Before the procedure transabdominal and transvaginal ultrasound will be done to diagnose PAS and to map the uterine wall defects.
~After 3 months,Transabdominal and transvaginal ultrasound with different modalities to assess the uterine wall, the cavity, endometrium, myometrium and the cervix. Isthmocele will be defined as a defect at uterine wall where residual myometrium thickness and ratio between residual myometrium and total myometrium thickness will be measured and recorded. The shape of the isthmocele will be also recorded."
15749201|NCT04866888|Diagnostic Test|outpatient hysteroscopy|Office hysteroscope will be done after patient consent to evaluate the uterine cavity if the patient is symptomatic or with abnormal sonography. It will be performed in the proliferative phase of the menstrual cycle. Non-steroidal anti-inflammatory will be given one hour before the procedure, then the patient will be in lithotomy position. Following aseptic rules, the rigid 4 mm hysteroscope will be inserted into the uterus through the cervix without using speculum nor tenaculum. Any pathology will be identified, and data will be recorded.
15749202|NCT04866875|Behavioral|dieting|The minimum amount of caloric intake will be pre-set in 1200 kcal for the both groups, in order to avoid micronutrient deficiencies during the intervention. The diet macronutrient composition will be personalized for each participant based on the results of 2-day energy intake at preliminary session, measured with food items selected from a validated food menu. Individuals will be instructed to maintain the level of energy restriction and macronutrient composition during the diet period, however they will be able to do food exchanges, based on the Canadian Diabetes Association system . This method allows individuals to select foods they enjoy during the weight loss, however in smaller quantities.
15749203|NCT04866862|Drug|Combination of Fruquintinib and Camrelizumab|Fruquintinib 5mg d1-21+Camrelizumab 200 mg d1
15749204|NCT04866849|Other|examination|"The presence of bruxism was based on self-reported bruxism and examination. Self reported bruxism was recorded as yes or no . Participants were examined for the existence of four clinical signs of bruxism: (I) abnormal tooth wear, (II) impressions of teeth in the buccal area, (III) impressions of teeth on the tongue, and (IV) hypertrophy of the masseter muscle. In this study, clinical signs of bruxism were considered present if one of the four items was answered yes."
15749205|NCT04866836|Combination Product|Radiotherapy|Patients who meet the criteria for enrollment first receive radiotherapy, either IMRT or SBRT, and the relative biological effect dose is> 40Gy. On the 7th day (±3 days) after radiotherapy, start to give tislelizumab 200 mg, IVD, q3w, and continue the treatment until disease progression, unacceptable toxic radiotherapy, death or meet the description in the protocol Any discontinuation criteria shall be subject to whichever occurs firs
15749209|NCT04866797|Other|cyclic merocyanine|long-UVA absorber
15749210|NCT04866797|Other|Placebo|Placebo
15749211|NCT04866784|Device|Transcutaneous Electrical Nerve Stimulation (TENS)|Transcutaneous electrical nerve stimulation (TENS) is a non-pharmacologic intervention for acute and chronic pain. This treatment involves the application of electric current through the skin; it is safe, easy to use, and inexpensive
15749212|NCT04866771|Other|Transcranial Direct Current Stimulation (tDCS)|Noninvasive brain stimulation
15749214|NCT04866758|Other|Survey|All data gathered will be quantitative in nature. In addition to participant completed surveys, additional demographic, and diagnosis/treatment related information will be collected from the patient's electronic medical record via Health Data Compass. Subsequent data collected as part of the patient's standard psychosocial and cancer related care (i.e., health outcomes, future utilization of UCCC psychosocial services) will also be gathered. This subsequent data collection will not include further participation, but continued access to the patient's medical record. Protected health information collected for this project will include dates (e.g., birth dates, date of diagnosis, date since last treatment, death dates) and participant zip codes. No other identifiable data will be collected. A separate survey emailed to the participant at the end of the study will collect information regarding the participant's completion status of the survey.
15749215|NCT04866745|Device|Magnetotherapy plus exercise|The VARIMAG-4E magnetotherapy device will be used. It is a pulsed radiofrequency energy device. The device has a voltage of 220V, 4 amps of intensity, 50 Hz of frequency and a maximum power of 100 Gauss. For the active treatment application, the patient will be in supine position and will introduce both knees in the 50 cm coil in case of bilateral knee osteoarthritis. In the case of unilateral knee osteoarthritis, the affected knee will be introduced in the 30cm coil. The duration of the treatment will be 20 minutes, the frequency administered will be 50 Hz and a power of 100 Gauss.
15749216|NCT04866745|Device|Microwave plus exercise|The application of deep heating therapy will be with the patient in a sitting position. The VARITRON 250-EP microwave device will be used with a frequency of 2450 MHz and a maximum output power of 250W. In the case of unilateral knee osteoarthritis, the circular applicator with a diameter of 170mm will be placed approximately 15 cm from the knee. The duration of the session will be 20 minutes, 10 minutes over the internal face and 10 minutes over the external face of the knee. In the case of bilateral knee osteoarthritis, the large lumbar applicator will be placed approximately 15 cm from the anterosuperior face of both knees for 20 minutes. The patient will have to perceive a moderate heat sensation.
15749217|NCT04866745|Device|Sham Magnetotherapy plus exercise|The protocol and device will be the same in the active/placebo treatment. The sham device does not emit an electromagnetic field. The energy from the active device is not felt by the user, and the active device cannot be distinguished in any way from the placebo device.
15749218|NCT04866732|Behavioral|Physical Activity Cardiac Health Program|The investigators anticipate that the physical activity program will include the following components: a) physical activity component - the investigators propose an incremental physical activity component whereby participants will gradually increase their physical activity ( duration of walk) from baseline to the end of the study; b) weekly informational sessions on various topics related to Cardiovascular disease risk factors prevention; c) daily diary, which will be used to document record about any barriers for completing various components of the intervention; d) problem-solving sessions whereby participants will meet once a week with the investigators to talk about the barriers and facilitators of their weekly activity and any adherence issues.
15749219|NCT04866719|Device|IOL implantation experimental|Mono- or bilateral implantation of toric intraocular lenses PODEYE TORIC. If only one eye qualifies for toric lens implantation due to small amount of pre-existing corneal astigmatism, one eye will be implanted with PODEYE TORIC and the contralateral eye will be receive an implantation with the monofocal parent lens PODEYE (PhysIOL sa/nv, Liège, Belgium).
15749220|NCT04866706|Device|Visiol|VISIOL is a 2.0% (m/v) SH viscoelastic solution used for ocular surgery.
15749221|NCT04866693|Other|None - this is an exploratory qualitative study to understand patient safety problems in community-based mental healthcare.|Qualitative study
15749222|NCT04866680|Procedure|Personalized Circulating DNA follow-up|FFPE tissue sample will be collected before and after surgery blood samples will be collected before and after surgery and every 3 to 4 months
15749223|NCT04866654|Drug|Nivolumab 10 MG/ML|Nivolumab, 100 mg, 10 mg/ml
15749224|NCT04866641|Drug|T-1201 Injection 100 mg Kit|T-1201 Injection 100 mg Kit contains lyophilized powder with a sterile aqueous solution formulated for intravenous administration.
15749225|NCT04866628|Dietary Supplement|Helichrysum italicum infusion|Comparison of metabolic syndrome components before and after four weeks of daily consumption of Helichrysum italicum infusion.
15749226|NCT04866628|Dietary Supplement|Helichrysum arenarium|Comparison of metabolic syndrome components before and after four weeks of daily consumption of Helichrysum arenarium infusion.
15749227|NCT04866615|Diagnostic Test|Optvue OCT|Optical coherence tomography
15749228|NCT04866602|Drug|Atoguanil|ATV-PG free base:125 mg: 87 mg, tablet
15749229|NCT04866602|Drug|Malarone|ATV-PG HCl: 250 mg: 100 mg tablet
15749230|NCT04866589|Behavioral|Distribution of free face masks|"Corona hosts will be placed at the entrance of the intervention stores, and hand out face masks to customers entering the store."
15749231|NCT04866576|Dietary Supplement|Q CAN PLUS|Active powder with fermented soy, 2 pouches per day, each pouch contains 12-15 gms of fermented soy
15749232|NCT04866576|Dietary Supplement|Placebo|Maltodextrin powder with Whey protein and flavor (provided by BESO Biological Research, Inc.)
15749233|NCT04866563|Drug|AX-8|orally disintegrating tablets, BID
15749234|NCT04866563|Drug|Placebo|orally disintegrating tablets, BID
15749235|NCT04866550|Other|Data collection|Daily record of temperature, weight, heart rate, systolic blood pressure and oxygen saturation
15749236|NCT04866524|Other|Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3|Ages & Stages Questionnaires®, Third Edition (ASQ®-3) is a developmental screening tool designed for use by early educators and health care professionals. It relies on parents as experts, is easy to use, family-friendly and creates the snapshot needed to catch delays and celebrate milestones.
15749237|NCT04866524|Other|Physical development and General Health|Physical development and General health examination
15749238|NCT04866524|Other|Developmental Red flags|Developmental Red flags Questionnaires
15749239|NCT04866511|Other|Narrative Exposure Therapy|"NET is a trauma-focused psychological treatment for people who experienced multiple traumas (Schaeur et al., 2011).
~An adaptation named KIDNET was developed for use with children and young people (Neuner et al., 2008; Schauer et al., 2011, 2017).
~Participants will be offered 6-10 weekly sessions of NET lasting approximately 90 minutes each. The sessions will be delivered by a Trainee Clinical Psychologist via videoconferencing, in line with the UK's Government guidelines around reducing face-to-face contacts during the Covid-19 pandemic."
15749240|NCT04866498|Drug|Infusion Intravenous|
15749242|NCT04866472|Device|video-laryngoscope and GlideRite Rigid Stylet|Once subject is in the operating room, standard monitoring will be instituted including nerve stimulator. Induction will follow standard practice.Once full muscle relaxation is confirmed with a train of four of 0/4 laryngoscopy will be preformed using a video-laryngoscope (VLS) with a #3 blade for women and a #4 blade men. Endotracheal intubation will be performed using a #7 endotracheal tube in women and # 8 in men using the GlideRite Rigid Stylet. The stylet will be shaped to the curvature of the blade of the VLS and lubricated with a water-based lubricant. After successful tracheal intubation the circuit will be connected and ventilation confirmed with capnography and auscultation.
15749243|NCT04866472|Device|video-laryngoscope and TCI Articulating Introducer Device|In the operating room, standard monitoring will be instituted including nerve simulator. Induction will follow standard practice. Once full muscle relaxation is achieved (train of four of 0/4) laryngoscopy will be performed using a video-laryngoscope (VLS) using a #3 blade in women and a #4 blade in men. A #7 endotracheal tube will be used for women and a #8 for men. Endotracheal intubation will be performed by placing the tube on the back of the TCI articulating introducer, after shaft is lubricated with a water based lubricant. The tip of the TCI articulating introducer will be maneuvered into the trachea and advanced until the green zone of the introducer shaft is adjacent to the glottis. The handle of the articulating introducer will then be removed and the ETT will be advanced over the articulating introducer and into the trachea via Seldinger's technique. Once in place the respiratory circuit will be connected and confirmed with capnography and auscultation.
15749244|NCT04866446|Device|endotracheal intubation and laringeal mask airway insertion|endotracheal intubation and laringeal mask airway insertion on the airway manikin with different devices
15749245|NCT04866433|Procedure|Real-time binaural sound|Play music with a frequency difference (real-time binaural sound) in each ear through headphones during sedation.
15749246|NCT04866433|Procedure|Music|Play the same music in both ears through headphones during sedation
15749247|NCT04866433|Procedure|Control|Just wear headphones during sedation
15749248|NCT04866420|Behavioral|The MenFAS Study|A cross over repeated exposure randomized design observational study
15749249|NCT04866407|Other|Mentha x piperita|2% solution of Mentha x piperita diluted in fractionated coconut oil for topical application will be applied to one extremity of the subjects in the 'Mentha x piperita' group.
15749250|NCT04866407|Other|Eucalyptus globulus|2% solution of Eucalyptus globulus diluted in fractionated coconut oil for topical application will be applied to one extremity of the subjects in the 'Eucalyptus globulus' group.
15749251|NCT04866394|Radiation|SBRT|Patients will be planned with the aim of delivering 30 Gy in 5 fractions.
15749252|NCT04866381|Drug|SHR-6390|SHR-6390
15749253|NCT04866381|Drug|SHR-6390 + Camrelizumab (SHR-1210)|SHR-6390 combined with Camrelizumab (SHR-1210)
15749254|NCT04866381|Drug|Camrelizumab (SHR-1210) + SHR-1020|Camrelizumab (SHR-1210) combined with SHR-1020
15749255|NCT04866368|Procedure|The ultrasound-guided Sacral Erector spinae plane block|postoperative pain procedure
15749256|NCT04866368|Procedure|The dorsal penile block|postoperative pain procedure
15749257|NCT04866355|Other|Lumbar spine manipulation|Lumbar spine manipulation
15749258|NCT04866355|Drug|Hyoscine and Ibuprofen|hyoscine (20 mg) and ibuprofen (400 mg) administered by oral via.
15749259|NCT04866342|Device|Servo control (closed-loop automatic control of the inspiratory fraction of oxygen (FiO2)) - IntellO2 OAM|"FiO2 adjustments will be made by the IntellO2 Oxygen Assist Module (OAM) for Precision Flow (IntellO2, Vapotherm, USA). By means of a modified closed-loop algorithm, the devise uses MasimoSET or Nellcor pulse oximetry to target a user-set SpO2 value.
~Manual adjustments of the inspired oxygen fraction can additionally be made as per standard care."
15749260|NCT04866329|Other|Blood sample|Additional blood sampling at the end of ovarian stimulation monitoring (the eve of the oocyte pick-up)
15749261|NCT04866329|Other|Urine sample|Collection of the first urine in the morning on the day of the oocyte pick-up
15749262|NCT04866329|Other|Follicular fluid and granulosa cells sample|Collection of follicular fluid and granulosa cells during oocyte pick-up.
15749263|NCT04866316|Other|There is no active intervention as this is a service evaluation|There is no active intervention as this is a service evaluation
15749264|NCT04866303|Diagnostic Test|Home-based SARS-CoV-2 test kit|A two-arm pragmatic randomized trial of SARS-CoV-2 home-based testing kit completion using active kit assistance by community health educators vs. passive kit delivery. Will be done with two partner communities, Yakima Valley Latino community in WA and Flathead Reservation, American Indian community in MT. N = 200 participants in each community.
15749265|NCT04866290|Device|HepaSphere Microspheres|
15749266|NCT04866277|Other|Fast-track referral for reference services|Activation of fast-track referral for specialized units and care programs for the four psychosocial and behavioural risk factors under study.
15749267|NCT04866264|Device|eNutrition Optimizer|The eNutrition optimizer is based on the electronic food frequency questionnaire (FFQ) used in the multicentre randomized controlled trail DO-HEALTH [56] developed by the CAM. The FFQ is split up in sections of 33 food groups and contains 216 items. It asks the user on the relative frequency of consumption of the different foods showing a picture of the food in the portion size of interest. Within the eNutrition Optimizer, the FFQ will be extended to create an output of the user's adherence to the Mediterranean diet, the MIND diet and the adherence with the current dietary recommendations for micro- and macronutrients provided by the Swiss Society for Nutrition and the DACH-references, compare it to the DO-HEALTH population and give recommendations on how to improve the score.
15749268|NCT04866251|Diagnostic Test|Gag reflex test; assessment of Mallampati Score|Testing of gag reflex Assessment of Mallampati Score
15749269|NCT04866238|Device|Vestibular fixed appliances|The fixed appliances will be applied in class1 malocclusion patients who have dental crowding, then they will be followed up for 12 months.
15749270|NCT04866238|Device|Clear aligners|The clear aligners will be applied in class1 malocclusion patients who have dental crowding, then they will be followed up for 12 months.
15749271|NCT04866225|Drug|Oral [14C]PF-06865571|Oral radiolabeled PF-06865571
15749272|NCT04866225|Drug|Oral PF-06865571|Oral PF-06865571
15749273|NCT04866225|Drug|IV [14C]PF-06865571|IV radiolabeled PF-06865571
15749471|NCT04864639|Other|Transition of Care Model|Participants with diabetes, Hispanic/Latinos, adults will receive newly developed culturally appropriate discharge instructions.
15749274|NCT04866212|Behavioral|Beery- Buktenica Developmental Test of Visual Motor Integration|Investigation of visual motor integration, motor coordination and visual perception by Beery- Buktenica Developmental Test of Visual Motor Integration.
15749275|NCT04866212|Behavioral|Jebsen Taylor Hand Function Test|Investigation of hand skills by Jebsen Taylor Hand Function Test
15749276|NCT04866212|Diagnostic Test|Participation and Environment Measure - Children and Youth|Investigation of participation by Participation and Environment Measure - Children and Youth
15749277|NCT04866173|Other|Dog|Subjection to standardised stress situations in the presence of a dog and a person
15749278|NCT04866173|Other|No Dog|Subjection to standardised stress situations in the presence of a person
15749281|NCT04866147|Procedure|Cardiothoracic surgery|Cardiac & large intrathoracic vessels, respiratory, thoracic, mediastinal & diaphragmatic procedures
15749282|NCT04866147|Procedure|Breast surgery|Breast resections & mastectomies
15749283|NCT04866147|Procedure|Gastrointestinal surgery|Digestive & spleen
15749284|NCT04866147|Procedure|Genitourinary surgery|Urinary tract, genital & retroperitoneal tissue
15749285|NCT04866147|Procedure|Obstetric surgery|Caesarian sections
15749286|NCT04866147|Procedure|Orthopaedic surgery|Back & neck, shoulder & upper arm, hip & thigh, knees & lower leg
15749287|NCT04866134|Drug|ERAS-007|ERAS-007 will be administered orally as specified in Arm description.
15749288|NCT04866121|Procedure|Acupuncture|A standardized acupuncture protocol will be administered
15749289|NCT04866108|Drug|fruquintinib plus capecitabine|oral fruquintinib plus capecitabine
15749290|NCT04866095|Device|Transthoracic echocardiogram|Transthoracic echocardiogram (TTE) is a widely used and validated imaging technique which involves the study of the heart and great vessels through multiple examination windows. In particular, the subcostal window represents the gold standard for evaluating the diameter of the inferior vena cava (IVC) and its compliance, allowing the physician to obtain valuable information on the volume status of patients. Acquiring images in the subcostal window with a transthoracic echocardiogram (TTE) can be, in some cases, difficult or impossible due to the presence of drainages or surgical wounds: in such cases an alternative could be represented by the trans-hepatic window. This has not been validated in the scientific litterature.
15749291|NCT04866095|Device|Clear Sight system|"The Clear Sight System is a non-invasive blood pressure (BP) monitoring system, where the CO is determined analysing the photo-plethysmography curve by a miniaturized pressure cuff and infrared LEDs.
~Its main advantage is to assess CO continuously in a completely non-invasive way, following its variations and thereby contributing to the detection of hypovolaemia. Other visualized parameters are: the stroke volume (SV), the systemic vascular resistance (SVR) as well as the BP and the heart rate (HR)."
15749293|NCT04866069|Biological|SARS-CoV-2 vaccine|Adjuvanted inactivated vaccine
15749294|NCT04866069|Biological|Placebo|0.9% NaCl
15749295|NCT04866056|Drug|Jaktinib|Jaktinib PO BID
15749296|NCT04866056|Drug|azacitidine|Azacytidine SC
15749301|NCT04866004|Behavioral|Contingency Management - Cannabis|Participants in the contingency management program will be provided financial incentives for 28-days of cannabis abstinence. At every visit, participants will provide urine samples for the biochemical verification of cannabis abstinence). Participants with evidence of cannabis abstinence will be provided a financial incentive that increases across subsequent study visits.
15749302|NCT04865991|Procedure|TCI Propofol|Peripheral venous catheters were placed in all subjects. Subjects in the TCI propofol group had one specific intravenous catheter for propofol infusion apart from medication or intravenous fluid line. Subjects in the TCI Propofol group received TCI propofol (Schneider) with targeted Ce 4 -5 mcg/ml for anesthesia induction and maintenance. Subjects in the TCI propofol group received TCI propofol for anesthesia maintenance, Ce value was titrated until a targeted BIS score of 40-60 achieved.
15749303|NCT04865991|Procedure|Sevoflurane|subjects in the sevoflurane group were cannulated only with one venous catheter. Midazolam 0.05 mg/kg BW and fentanyl 1 mcg/kg BW were given as premedication. Subjects in the sevoflurane group received intravenous propofol 1 - 2 mg/kg BW.
15749307|NCT04865965|Procedure|Acute Bout of Exercise|Exercising for 60 minutes at 55-60% of VO₂ peak
15749308|NCT04865952|Procedure|periodontal surgery + 24 hr buccal attached gingiva (G) biopsy|Periodontal surgery will be performed and 24 hr after the surgical procedure a 2mm punch biopsy will be harvested at the level of the buccal attache gingiva (G).
15749309|NCT04865952|Other|Intra-surgical HA application|Intra-surgical HA will be infiltrated around the vertical released incisions (VRIs)
15749384|NCT04865445|Drug|AT-527 550 mg + midazolam|"Day 1: 2 mg midazolam Day 3: 550 mg AT-527 and 2 mg midazolam (with dosing offset by 2 hrs) in the morning and a second 550 mg AT-527 dose in the evening.
~Days 4 to 6: 550 mg AT-527 administered twice daily (BID) Day 7: 550 mg AT-527 and 2 mg midazolam (with dosing offset by 2 hrs) in the morning and a second 550 mg AT-527 dose in the evening.
~Other Names: AT-527 is also know as R07496998"
15749312|NCT04865926|Other|Scapular and Neck Proprioceptive Neuromuscular Facilitation exercises|The researcher will perform a total of 12 sessions of scapular and neck pnf exercises for 4 weeks. The participants will apply PNF exercises using rhythmic initiation, rhythmic stabilization and cobination techniques of isotonics. Patterns of anterior elevation, posterior depression, anterior depression, posterior elevation will be used in scapular exercises. Upper cervical flexion, lower cervical flexion, rotation and lateral flexion patterns will be used in neck pnf exercises.
15749313|NCT04865926|Other|McKenzie and Kendall exercises|Kendall and Mckenzie exercises will be given to the participants as a home workout. The self-stretch exercise methods are as followed: Placing both hands on the shoulders and pushing out the chest, placing one hand over the shoulder and grasp the elbow of the turned hand, with the other hand over the head and slowly pull it inward, throwback the head until it has reached the fully stretched point, look straight ahead and slowly turn the head horizontally until the maximum value is reached, throwback the head, and turn it until it has reached the fully stretched point, lower the head turn it until it has reached the maximal point. Stretching pectoralis muscle, strengthening shoulder retraction, strengthening the deep cervical flexors, strengthening the deep cervical flexors.
15749314|NCT04865913|Other|Observational|A brief 15 min phone call 1 week, 30 and 90 days post discharge.
15749315|NCT04865900|Diagnostic Test|Laboratory Blood Tests|Blood tests to determine liver and kidney functioning, total blood count, and troponin levels
15749316|NCT04865900|Diagnostic Test|ECG|ECG to determine heart rate and functioning
15749317|NCT04865900|Diagnostic Test|PCR|PCR test to determine whether patient has Covid19
15749318|NCT04865900|Diagnostic Test|Antibody test|Antibody test to determine level of antibodies to Covid19
15749319|NCT04865900|Diagnostic Test|Echocardiography|If Troponin level elevated echocardiography to determine heart function
15749320|NCT04865900|Diagnostic Test|MRI|If Troponin level elevated MRI to determine heart function
15749321|NCT04865887|Drug|Pembrolizumab|200mg, every 3 weeks, IV infusion
15749322|NCT04865887|Drug|Lenvatinib|20 mg (2 capsules x10mg), daily, orally
15749323|NCT04865874|Other|PPV-GDT|fluid-therapy based on PPV monitoring
15749324|NCT04865874|Other|Zero-balance|fluid-therapy based on urinary output balance
15749325|NCT04865848|Procedure|Dental local anesthesia|Dental local anesthesia
15749326|NCT04865835|Drug|placebo|single dose of placebo
15749327|NCT04865835|Drug|SEP-363856|single dose of SEP 363856 100 mg
15749328|NCT04865835|Drug|metformin|metformin-HCl 850 mg
15749329|NCT04865822|Behavioral|Single session pain education class|Pain education classes will be provided in person group or virtual settings
15749330|NCT04865809|Other|Peribioma Toothpaste and Mousse|Use of Peribioma Toothpaste and Mousse for home oral care.
15749331|NCT04865809|Other|Standard toothpaste|Use of standard toothpastes for home oral care
15749332|NCT04865796|Other|Lactoferrin products|Patiens will use a toothpaste and 2 tablets per day (between foods) for home oral care.
15749333|NCT04865796|Other|Probiotics products|Patiens will use a toothpaste and a chewing-gum (for 10 minutes a day) for home oral care.
15749334|NCT04865796|Other|Standard home oral care|Patiens will use a normal toothpaste for home oral care.
15749335|NCT04865783|Procedure|Saline spray|The saline spray will be applied twice for 1-2 seconds.
15749336|NCT04865783|Procedure|Cryospray|The cryospray will be applied twice for 1-2 seconds.
15749339|NCT04865757|Device|Space Flap|A space flap is formed out of Palacos®, adjusted to the skull surface with temporal augmentation
15749340|NCT04865744|Drug|Semaglutide 7 MG Oral Tablet|Semaglutide 7 mg oral tablet taken after an overnight fast with 120 ml of water.
15749341|NCT04865744|Drug|Placebo|Placebo tablet is taken after an overnight fast with 120 ml of water.
15749342|NCT04865731|Drug|Dermaprazole|Patients will be managed with twice daily prophylactic use of the proposed intervention (Dermaprazole) topical cream for radiation dermatitis. The amount of cream will be 2cc per application and will be measured in pre-filled capped syringes for every application.
15749343|NCT04865731|Drug|Aquaphor|Patients will be managed with twice daily prophylactic use of Aquaphor. The amount of Aquaphor will be 2cc per application and will be measured in pre-filled capped syringes for every application.
15749344|NCT04865718|Diagnostic Test|ICGA imaging|subjects undergoing intraoperative ICGA imaging
15749345|NCT04865705|Drug|tislelizumab|Tilelizumab 200mg d1 Q3W Albumin Paclitaxel 260mg/m2 d1 Carboplatin/Cisplatin 75mg/m2/AUC5 d1 every 3 weeks
15749346|NCT04865692|Other|BFRT|Patients of Interventional group were treated with routine physiotherapy program combined with LI-BFR consist of 10 minutes' session 3 per week for 12 weeks. In order to determine the training load 20% of 1RM, participants had performed knee extension in full range with a challenging weight. After each test, participants rated their perceived exertion level on (RPE) scale to determine the difficulty of the resistance. The derived 1RM was used to determine the 20% 1RM load used for low-load training. Blood flow restriction proximal to the working muscles achieved through using pressure cuffs. The cuff was applied to the proximal thigh. During week 1 the inflation pressure was 100mmHg. Final exercise pressure based the week of the training. Quadriceps size was measured by tape measures thigh
15749347|NCT04865692|Other|Routine Physical Therapy|knee isometrics, resisted knee extension with chalanging weight 2 sets of 10 Reps with 5 sec hold
15749348|NCT04865679|Device|Axoguard Nerve Cap®|Entubulation of the nerve stump into the Axoguard Nerve Cap® following surgical excision of symptomatic neuroma
15749385|NCT04865432|Device|UVB treatment|5 weeks of UVB titration to determine individual's UVB sensitivity followed by 4 weeks of UVB exposure intervention
15749386|NCT04865419|Drug|AZD0466|AZD0466 powder for concentrate for solution for infusion will be administered by IV infusion.
15749387|NCT04865419|Drug|Voriconazole|Voriconazole film-coated tablet will be administered orally.
15749388|NCT04865393|Drug|SPR206|SPR206 100 mg single-dose IV infused over 1 hour
15749389|NCT04865380|Drug|Tranexamic Acid 100 MG/ML|1g IV x 1 dose of Tranexamic Acid administered preoperatively.
15749349|NCT04865666|Device|movr mHealth App|The exercises prescribed through the movr app were accompanied with videos, images, and detailed instructions on how to complete them. These exercises consisted of basic movement and mobility patterns and are designed to promote functional movement. Participants were instructed to complete a total of four 'Minis' and two workout 'Builder' sessions per week. Workout Builders are designed to be longer exercise sessions tailored to the user's desired exercise time (15, 30, 45 or 60 min), equipment available (TRX Band, kettlebell, chin-up bar, dumbbells, foam roller, or none), target body region (lower, upper, or whole body), and specific exercise goal ('get sweaty,' 'build strength,' or 'develop mobility'). Version 3.6 of the movr app was used at the start of data collection and was updated to Version 4.1 over the course of the trial. No significant changes were made to the app or to the exercise prescription functionality throughout those updates.
15749350|NCT04865653|Drug|Lysergic Acid Diethylamide Base oral drinking solution|A moderate dose of 0.1 mg LSD will be administered.
15749351|NCT04865653|Drug|Lysergic Acid Diethylamide Base solid orodispersible film|A moderate dose of 0.1 mg LSD will be administered.
15749352|NCT04865653|Drug|Lysergic Acid Diethylamide Tartrate oral drinking solution|A moderate dose of 0.146 mg LSD tartrate will be administered (equivalent to 0.1 mg LSD base).
15749353|NCT04865653|Drug|Lysergic Acid Diethylamide Tartrate intravenous administration|A moderate dose of 0.146 mg LSD tartrate will be administered (equivalent to 0.1 mg LSD base).
15749354|NCT04865653|Other|LSD Placebo|Placebo for each formulation containing only the solvent or gel but no LSD.
15749355|NCT04865640|Diagnostic Test|Noninterventional and noninvasive|The ADI At-Home CPM (Cardiopulmonary Management) System is intended for adults undergoing monitoring for cardiopulmonary conditions under the direction of a licensed medical professional to measure, record, and periodically transmit physiological data.
15749356|NCT04865627|Device|activity monitor|Both groups will wear three different activity monitors for one week. There is one observation moment which consists of four minutes lying, sitting, standing, walking and taking stairs. Participants will be filmed during this moment.
15749359|NCT04865601|Other|resectomy of the colon|The patient scheduled for colon resectomy are included in the study
15749360|NCT04865588|Procedure|rotational atherectomy|angioplasty with rotational atherectomy - a rotating instrument used to break up the calcification
15749361|NCT04865588|Device|cutting balloon|a balloon with microsurgical blades on its outer surface which make longitudinal incisions in the calcified area in order to open resistant clogs
15749362|NCT04865588|Device|plain old balloon|current standard treatment of stent placement
15749363|NCT04865562|Drug|testosterone propionate|1mg/0.1mL solution, to be administered intranasally
15749364|NCT04865562|Drug|0.5% cholorbutanol, saline|125 mg 0.5% cholorbutanol, 50mg saline
15749365|NCT04865549|Procedure|SNB + TAD + Lymphadenectomy|Sentinel Node Biopsy + Targetted Axillary Dissection (Previously to surgery marked cN1 node) + Lymphadenectomy
15749366|NCT04865536|Drug|1800 mg TBI-223|3 x 600 mg SR1 tablets
15749367|NCT04865536|Drug|2400mg TBI-223|3 x 600 mg SR1 tablets and 1 x 600 mg IR tablets
15749368|NCT04865536|Drug|3000mg TBI-223|4 x 600 mg SR1 tablets and 1 x 600 mg IR tablets
15749369|NCT04865536|Drug|TBI-223 Placebo|3 x Placebo tablets
15749370|NCT04865536|Drug|TBI-223 Placebo|4 x Placebo tablets
15749371|NCT04865536|Drug|TBI-223 Placebo|5 x Placebo tablets
15749372|NCT04865523|Other|Manual Lymphatic Drainage|Manual lymphatic drainage is a technique that through gentle passes facilitates the flow of lymph through manual therapy techniques based on Vodder therapy. This technique is being studied to know its effectiveness in pain and for this reason we want to carry out this research.
15749373|NCT04865510|Procedure|Regional citrate anticoagulation|"The investigators collected patient's plasma at study start (day 0) and at day 3, 5, 7, 14, 28) .Samples were used to measure inflammatory markers (Il 6, IL 8, IL 10 and TNFα) .
~. Markers of dialysis efficiency (BUN, creatinine) and other parameters related to AKI (acid base status, calcium, phosphorus, hemoglobin). The recorded variables also included adverse events, dialysis clotting, hemodynamic status, duration of mechanical ventilation, inotropic support. The hemodynamic parameters were monitored by EV 1000 clinical platform .The investigators measured cardiac performance data, which includes cardiac output (CO), cardiac index (CI), stroke volume (SV), and stroke volume indexes (SVI). Moreover, it also provides information about systemic vascular resistance (SVR). Thus, patient hemodynamic parameters as mentioned above were measured at the following 6 time-point: after the initiation of CRRT (T1), every 6 hours later for 24 hours (T2, T3, T4, T5), and at hour-72 (T6)."
15749374|NCT04865497|Biological|S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine|Group 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine.
15749375|NCT04865497|Biological|S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine|Group 2:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 5 µg S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine.
15749376|NCT04865497|Biological|S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine|Group 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg adjuvant-free S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine.
15749377|NCT04865497|Biological|Haemophilus b Conjugate Vaccine|Group 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg Haemophilus b Conjugate Vaccine.
15749378|NCT04865484|Procedure|Surgical resection|Surgical resection of fibrostenotic area (>4cm)
15749379|NCT04865484|Procedure|Endoscopic stricturotomy|Endoscopic stricturotomy of fibrostenotic area (≤4cm)
15749380|NCT04865484|Procedure|Strictureplasty|Strictureplasty of fibrostenotic area (≤4cm)
15749381|NCT04865471|Procedure|Liver transplantation|Auxiliary liver transplantation and staged hepatectomy
15749382|NCT04865458|Drug|HEC89736|HEC89736 tablets QD every 28 days for each cycle
15749383|NCT04865445|Drug|AT-527 550 mg + midazolam|"Day 1: 2 mg midazolam Day 3: 550 mg AT-527 and 2 mg midazolam in the morning and a second 550 mg AT-527 dose in the evening.
~Days 4 to 6: 550 mg AT-527 administered twice daily (BID) Day 7: 550 mg AT-527 and 2 mg midazolam in the morning and a second 550 mg AT-527 dose in the evening.
~Other Names: AT-527 is also know as R07496998"
15749390|NCT04865367|Other|Exposure to culture media|Exposure to culture media
15786142|NCT04563624|Drug|ceramic cad cam blocks|ceramic cad cam blocks
15749393|NCT04865341|Behavioral|IMB|Intervention content will be focused on the Information-Motivation-Behavioral Skills (IMB) model. We plan to incorporate previously developed content as much as possible and will include professionally produced videos about HIV testing and PrEP and other resources. We believe our approach of guiding YMSM through intervention modules based on theory will help improve content retention/use and ultimately influence constructs posited to result in behavior change. We foresee using multiple forms of attention-matched material, media, and programming to engage (and retain engagement) of YMSM throughout the brief single-session intervention (45-60 minutes).
15749394|NCT04865328|Other|Overactive Bladder-Validated 8-question Screener (OAB-V8)|OAB-V8 is an eight-item, self-reported questionnaire that assesses the burden of OAB and the degree of bother caused by the symptoms. Since its development as a subscale of the overactive bladder questionnaire (OAB-q), the OAB-V8 questionnaire has been used to screen for OAB and to assess OAB symptom burden and severity.
15749395|NCT04865302|Procedure|SSC|"Incubator phase I: After feeding the neonates will be brought in a prone position in the incubator and the NIRS sensor will be applied on the forehead for continuous cStO2 measurements throughout the study period. The neonate will rest in this position for 60 minutes.
~SSC phase: The neonate will be brought on the mother's or father's chest (skin to skin) in a prone position and will stay in this position for 60 minutes.
~Incubator phase II: The neonates will be brought back into the incubator for another 60 minutes in prone position. After 180 minutes the study period is over and the NIRS sensor will be removed."
15749400|NCT04865276|Behavioral|Integrated tobacco cessation intervention delivered by Community Health Workers with the support of an App (mHealth) + Tobacco cessation program at the public health system|Integrated tobacco cessation intervention delivered by Community Health Workers with the support of an App (mHealth) + Tobacco cessation program at the public health system
15749401|NCT04865263|Device|Digital Pain-Management Tool|Self management digital tool for chronic pain
15749402|NCT04865250|Drug|Atezolizumab|Immune checkpoint blockade antibody ATEZOLIZUMAB directed against PD-L1 (Programmed death-ligand 1); Carboplatin; Nab-Paclitaxel
15749403|NCT04865237|Biological|SARS-CoV-2 Virus|SARS-CoV-2, intranasally, (1x10^1 TCID50, 1x10^2 TCID50 and 1x10^3 TCID50 or higher, as necessary)
15749404|NCT04865237|Drug|Remdesivir|VEKLURY™
15749405|NCT04865224|Diagnostic Test|hemoglobin estimation|In this method, in which different deep learning models are used together, the age range is intended to be as wide as possible to provide a quick solution with a high accuracy and low error values.
15749406|NCT04865211|Drug|Liposomal bupivacaine|Use of liposomal bupivicaine as intraoperative local anesthesia
15749407|NCT04865211|Drug|Bupivacaine Injection|Use of bupivicaine as intraoperative local anesthesia
15749408|NCT04865211|Drug|Placebo|Use of saline as placebo for local anesthesia
15749409|NCT04865198|Diagnostic Test|Neurl1 gene expression|This observational case control study. The gene expression was examined.
15749410|NCT04865198|Diagnostic Test|RGS14 gene expression|This observational case control study. The gene expression was examined.
15749411|NCT04865185|Diagnostic Test|Xylocaine spray 100mg/ml|Topical application
15749412|NCT04865185|Diagnostic Test|Ethanol|Topical application
15749413|NCT04865172|Other|Remote collection of passive and active data for 28 consecutive days|Passive sensor data: collected continuously for 28 days, from a multi-sensor wearable bracelet worn by each member of the dyad; Active questionnaire data: collected once a week during the four weeks of monitoring (and at the end of the 28 days for patient-caregiver dyads), from questionnaires filled by one partner of the dyad (for patient-caregiver dyads, this will be the caregiver) using a smartphone application.
15749414|NCT04865159|Drug|Tipifarnib|Cardiac Safety of Tipifarnib
15749415|NCT04865146|Device|TRIGEN™ INTERTAN™|Femoral fracture treated with INTERTAN 10S Nail
15749416|NCT04865133|Procedure|Biospecimen Collection|Undergo blood sample collection
15749417|NCT04865133|Other|Electronic Health Record Review|Medical record reviewed
15749418|NCT04865120|Other|cream cyclic merocyanine|cream long-UVA absorber
15749419|NCT04865120|Other|placebo|placebo
15749420|NCT04865107|Biological|UC-MSCs|3 daily doses of up to 90-million cells/unit dose (cumulative dose of up to 270 million UC-MSCs)
15749421|NCT04865107|Biological|Placebo|PlasmaLyte A and 5% Human Albumin
15749422|NCT04865094|Other|cyclic merocyanine|long-UVA absorber
15749423|NCT04865094|Other|placebo|placebo
15749424|NCT04865081|Device|VACCIN box|The VACCIN box is a translucid box that can be placed over the patient's head. It has entry holes on the front and the side of the box in which nitrile gloves can be attached. The anesthesiologist can intubate with arms and hands inside the box. Its also has the capacity to create a negative pressure environment inside the box by connecting an air suction cable from the box to the OR medical aspiration line.
15749425|NCT04865068|Diagnostic Test|Echocardiography measures on SSA participants|"Upon SSA Subject is admitted to the hospital for an echocardiography,
~Information about this study process,
~Participants will receive an information note ;
~Administration of a medical history questionnaire, collection of cardiovascular risk factors, weight toe (all of which are routinely collected before an echocardiographic examination is performed);
~Performing and recording the echocardiographic examination according to routine protocol
~delivery of the results according to the usual management;
~deferred analysis of the recordings on workstation with classification of the data (normal-pathological) according to the different standards"
15749426|NCT04865055|Other|cyclic merocyanine|long-UVA absorber
15749427|NCT04865055|Other|placebo|placebo
15749428|NCT04865042|Drug|Gabapentin 300mg|"The patient will receive in addition to the usual analgesic treatment, the treatment under study: Gabapentin.
~During the first 3 days of his hospitalization, an evaluation of the pain and the tolerance to the treatment will be performed.
~The patient will have to take the treatment as follows:
~Day 1 (1st day of hospitalization): 1 capsule/day
~Day 2: 2 capsules/day
~Day 3: 3 capsules/day 72 hours after the first treatment, a blood test will be performed."
15749429|NCT04865042|Drug|PLACEBO|"The patient will receive in addition to the usual analgesic treatment, the Placebo During the first 3 days of his hospitalization, an evaluation of the pain and the tolerance to the treatment will be made.
~The patient will have to take the treatment as follows:
~Day 1 (1st day of hospitalization): 1 capsule/day
~Day 2: 2 capsules/day
~Day 3: 3 capsules/day 72 hours after the first treatment, a blood test will be performed."
15749430|NCT04865029|Other|Placebo injection and placebo pill|Standard of Care consistent with the National Institutes of Health (NIH) COVID-19 Treatment Guidelines
15749431|NCT04865029|Drug|Estradiol Cypionate 5 MG/ML|Standard of Care along with Estradiol Cypionate 5mg intramuscular injection at admission.
15749432|NCT04865029|Drug|Progesterone 200 MG Oral Capsule|Standard of Care along with Progesterone 200mg by mouth daily for 5 days starting at admission.
15749433|NCT04865016|Device|Tecnis +2.75 D (ZKB00) and Tecnis Symfony (ZXR00)|This study included 30 eyes of 15 cataract patients undergoing cataract surgery with implantation of a low add (+2.75 Diopters [D]) bifocal (Tecnis ZKB00; Johnson and Johnson Surgical Vision Inc., Jacksonville, Florida, USA) IOL (MIOL Group) and 30 eyes of 15 patients with implantation of an EDOF (Tecnis Symfony [ZXR00]; Johnson and Johnson Surgical Vision Inc., Jacksonville, Florida, USA) IOL (EDOF Group).
15749434|NCT04865003|Other|treatment of infection|
15749435|NCT04864977|Drug|Basal Insulin|Participants administered basal insulin
15749436|NCT04864964|Procedure|combined conventional and pulsed radiofrequency (CCPRF)|Patients with trigeminal neuralgia who underwent combined conventional and pulsed radiofrequency (CCPRF) for treatment of pain.
15749437|NCT04864951|Diagnostic Test|Colli-Pee urine collection device|first-void urine is collected using Colli-Pee and subsequently analyzed using Anyplex™ II HPV HR Detection from Seegene.
15749438|NCT04864951|Other|Survey|Subjects are asked to complete a survey that includes questions about sexual orientation, hormone therapy, gender reassignment surgery, number of sexual partners, HPV vaccination, and smoking
15749439|NCT04864925|Drug|Colgate Total Clean Mint|2 minutes of whole mouth toothbrushing
15749440|NCT04864925|Drug|Tom's Botanically Bright Peppermint|2 minutes of whole mouth toothbrushing
15749441|NCT04864912|Other|Questionnaires and survey|Questionnaires: Health Utilities Index Mark III, Chronic Otitis Media Outcome Test-15 and Speech, Spatial, and Qualities of Hearing Scale-12 Survey: Client Service Receipt Inventory (adapted version)
15749442|NCT04864899|Diagnostic Test|Cardiac Magnetic Resonance Imaging (CMR)|Imaging
15749443|NCT04864899|Diagnostic Test|Blood test|Blood investigation
15749444|NCT04864899|Diagnostic Test|6-minute walk test|Correlating the cardiac MRI parameters with functional capacity
15749445|NCT04864873|Diagnostic Test|Metagenomic next generation sequencing using Oxford Nanopore|See previous.
15749446|NCT04864873|Diagnostic Test|Standard microbiological diagnostic pathway|See previous.
15749447|NCT04864860|Dietary Supplement|brown seaweed (ecklonia cava)|"The intervention product used in this study is a dietary supplement called Seanol that contain 13% pholoratannic polyphenol per capsule as stated by the manufacture company (Seanol inside, 4215 95th St SW Lakewood, WA 98499 USA). Other ingredients are dextrin, magnesium stearate and silica (in neglected percentage). The intervention supplement is encapsulated in vegetable cellulose that contains 500 Ecklonia cava extract (Seanol). The placebo will be dextrin (BETA CYCLODEXTRIN, NF) ordered from a pharmaceutical company MEDISCA (https://www.medisca.co.uk/). Dextrin was selected to account for the similar complex carbohydrate content of the intervention supplement. Placebo will be encapsulated in vegetable cellulose capsules that is identical in size and coulure to the intervention capsules. The empty capsules will be ordered from MEDISCA and will be encapsulated in by SPIMACO ADDWAIEH (SFDA registered pharmaceutical company) (http://www.spimaco.com.sa/)."
15749448|NCT04864847|Diagnostic Test|RENISCHEM L-FABP POC Test|Point-of-care test cassette with quantitative reader used for the measurement of L-type fatty acid binding protein (L-FABP) in human urine specimens.
15749451|NCT04864821|Drug|Targeting CD276 CAR T cells|Targeting CD276 autologous chimeric antigen receptor T cells
15749452|NCT04864808|Behavioral|Behavioral Parent Training|Parents will receive sessions of behavioral parent training with components specifically targeted toward parents with ADHD. The number of sessions will be informed based on stakeholder feedback. Treatment will be delivered via telehealth.
15749453|NCT04864782|Drug|QL1604|Intravenous Infusion
15749454|NCT04864782|Drug|Paclitaxel injection|Intravenous Infusion
15749455|NCT04864782|Drug|Cisplatin/Carboplatin|Intravenous Infusion
15749456|NCT04864769|Dietary Supplement|Krill protein hydrolysate|Ingestion of 35 g Krill protein hydrolysate
15749457|NCT04864769|Dietary Supplement|Soy protein isolate|Ingestion of 35 g Soy protein isolate
15749458|NCT04864769|Dietary Supplement|Whey protein isolate|Ingestion of 35 g Whey protein isolate
15749459|NCT04864769|Dietary Supplement|Water|Ingestion of water (control)
15749460|NCT04864756|Other|Simulation based learning|Learning for medical students using simulation based techniques including scenario execution as a complement to conventional teaching methodologies
15749461|NCT04864743|Drug|ADVATE|a single dose.
15749462|NCT04864743|Drug|FRSW117|a single dose.
15749463|NCT04864730|Other|No intervention|No intervention
15749464|NCT04864717|Drug|Doxycycline 100mg po once daily x 6 months|active intervention
15749465|NCT04864717|Drug|Isotretinoin 40 mg po once daily x 6 months|active intervention
15749466|NCT04864704|Other|dry needling|Physical therapy
15749467|NCT04864691|Biological|endovascular recanalization|to recanalize the occlusion cerebral artery with intravascular intervention
15749468|NCT04864678|Other|Referral to the Young People's Health Service immunisation nurse|Young people who have been referred to an immunisation nurse at the Young People's Health Service.
15749469|NCT04864665|Dietary Supplement|a formula with prebiotics and milk fat|Provided in a formula added with prebiotics and milk fat for 1 month
15749470|NCT04864652|Device|CHILLS Procedure|CHILLS Cryotherapy procedure
15749472|NCT04864626|Other|semi-standardized interview|annual collection of the number of consultations and hospitalizations at the center, as well as the number of treatments
15749473|NCT04864626|Other|care experience questionary|questionary with 12 questions to rate the quality of the telephone reception and your feelings during the interview
15749474|NCT04864600|Other|Candle C|Burning candles will produce particulate air pollution being passed on an exposure chamber where the participants will be sitting for 5 hours.
15749475|NCT04864600|Other|Candle 1|Burning candles will produce particulate air pollution being passed on an exposure chamber where the participants will be sitting for 5 hours.
15749476|NCT04864587|Diagnostic Test|Artificial intelligence used for image recognition in pouchoscopy|The aim of this study is to develop an image recognition algorithm that reliably detects the different graduations of pouch inflammation and neoplasms in the pouch
15749477|NCT04864574|Other|Garden installation|"Garden installation: 6 raised planting beds (4x6x16) configured in a single line with direct sun at least 6 hrs./day, close to hose bib, sufficient distances to allow working from most sides, vegetable vines spill over space, and storage unit for tools.
~Planting beds constructed from a standard kit. Beds filled with high quality growing medium.
~Plants selection criteria: a) documented harvest success in NC Piedmont; b) able to be eaten raw, c) harvest times at the same time (except strawberries).
~Designated beds and plants: Bed 1: 4 pepper, 2 tomato; Bed 2: 20 bean on 2 mini-teepees, 2 cucumber (trellised); Bed 3: 1 yellow squash, 1 zucchini; Bed 4: 2 blueberry bushes, 12 strawberry; Bed 5: 2 cantaloupe. Bed 6: 2 watermelon. 2 Blackberries planted at ground level on trellis."
15749480|NCT04864548|Biological|SARS-CoV-2 virus|The SARS-COV-2 challenge virus strain was originally obtained from a nose/throat swab taken from a patient who developed respiratory symptoms consistent with COVID-19. The isolate was plaque purified to obtain a 'single' virus entity. The selected plaque, B1, was subsequently manufactured in accordance with GMP at the Great Ormond Street manufacturing suite.
15749481|NCT04864535|Diagnostic Test|Recordings of cough sounds from adults|Smartphone recordings of the cough sounds of participants who enrol in the study and obtain a COVID-19 rt-qPCR result.
15749482|NCT04864522|Drug|SLAMF7 BATs|Participants will receive 4 weekly infusions of SLAMF7 BATs, then 4 infusions every 2 weeks. Participants that have stable disease or better at week 10 of treatment may continue to receive an infusions every 4 weeks for up to a total of 21 infusions (including the first 8).
15749483|NCT04864509|Drug|Melatonin 10 MG|Nightly dose
15749484|NCT04864509|Drug|Placebo|Nightly dose
15749485|NCT04864496|Drug|Prescribe N-acetylcysteine tablets|N-acetylcysteine tablets ,1200 mg two times daily
15749486|NCT04864496|Drug|Prescribe placebo tablets|manufactured by Daroo Salamat Pharmed, two times daily
15749487|NCT04864483|Other|Meal timing in relation to time of starting the fast|as described
15749488|NCT04864470|Behavioral|Stroke Odysseys|"The participants will take part in a twelve-week performance programme that takes place online/in a community halls/arts centre. Sessions run for three hours and during these sessions, participants devise a dance and music performance work from their own stories. The culmination of the programme will be a public facing performance to an audience of carers, health care practitioners, friends, family and the wider community, done online through Zoom.
~After the performance is completed, participants will be invited to a training programme where they learn to act as advocates for life after stroke - termed 'stroke ambassadors'. The training will be a four-day programme. The programme will take place once weekly and is led by a team of artists supported by a leadership coach, on Zoom.
~Following training, ambassadors will support artists in recruitment, befriend the newly discharged stroke survivors and take part in small scale performance tours to challenge the perception of disability."
15749489|NCT04864444|Drug|Dihydroartemisinin-piperaquine|DHA-PPQ will be given over the course of three consecutive days using 160mg/20mg or 320mg/40mg of dihydroartemisinin/piperaquine tablets. DHA-PPQ will be administered via age-based dosing. All three doses will be directly observed and given orally with water and without food.
15749490|NCT04864444|Drug|Primaquine|Primaquine will be given once with the first dose of DHA-PPQ. Primaquine will be administered in an aqueous solution according to age-based dosing guidelines.
15749491|NCT04864431|Dietary Supplement|Vitamin D|Vitamin D capsules: each capsule contain 2 tablets of vitamin D 1000 IU. One capsule will be taken on day 1 through 180
15749492|NCT04864431|Other|Placebo|Placebo capsule: Each capsule contain saccharum lactis. One capsule will be taken on day 1 through 180
15749493|NCT04864418|Drug|AST-021p|3 priming immunization (2weeks x3) in 4 cohort groups (1.2mg, 2.4mg, 3.6mg and 4.8mg AST-021p) if possible, 3 boosting immunization (4weeks x 3) in cohort groups after priming immunization
15749494|NCT04864405|Other|Morning administration of endocrine therapy|Endocrine therapy administered within one hour of patient wake up time
15749495|NCT04864405|Other|Evening administration of endocrine therapy|Endocrine therapy administered within one hour of the patient bed time
15749496|NCT04864392|Drug|LNA043 Dosing Regimen A|Injection to the knee
15749497|NCT04864392|Drug|LNA043 Dosing Regimen B|Injection to the knee
15749498|NCT04864392|Drug|LNA043 Dosing Regimen C|Injection to the knee
15749499|NCT04864392|Drug|LNA043 Dosing Regimen D|Injection to the knee
15749500|NCT04864392|Drug|Placebo|Injection to the knee
15749501|NCT04864379|Biological|iNeo-Vac-P01|iNeo-Vac-P01: 300 mcg per peptide
15749502|NCT04864379|Other|GM-CSF|GM-CSF: 40 mcg
15749503|NCT04864379|Drug|PD-1|PD-1: 200mg administered by intravenous infusion every 2 weeks.
15749504|NCT04864379|Procedure|RFA|Radiofrequency ablation surgery
15749505|NCT04864366|Drug|Tenofovir Alafenamide 25 MG [Vemlidy]|TAF is administered as a 25mg/tablet, taken orally with food once daily, for 48 weeks.
15749506|NCT04864353|Behavioral|RestDep: Internet-delivered intervention targeting residual cognitive symptoms|The intervention is fully digital with weekly telephone guidance. Key intervention elements are 1) psychoeducation, 2) attention training, 3) strategy training. Cognitive domains as attention, memory and executive functions are covered and rumination.
15749507|NCT04864340|Device|CE marked medical device|Tetanic stimulation
15749508|NCT04864340|Device|Algometer|Pressure stimulation
15749510|NCT04864327|Behavioral|Brief smoking cessation advise|The tobacco cessation protocol consisted of performing a routine assessment (asking) of cigarette use; providing advice on the importance of quitting; performing an assessment of the tobacco user's readiness to quit; assisting in setting a quit date; and making arrangements for follow-up visits. This protocol is popularly known as the 5A's strategy (The first 3A's should be delivered to all smokers regardless of their willingness to quit). Tobacco users were identified by staff nurses. Clinicians provided brief advice on quitting, and the researcher assessed the patient's dependence and readiness to quit. Patients who were not ready to quit were motivated to consider quitting, whereas those who were ready to quit were referred to practitioners who could assist them and follow them in the tobacco cessation clinic
15749511|NCT04864314|Dietary Supplement|Marine microalgae Tetraselmis chuii with high Superoxide Dismutase (SOD) activity|Participants in the Experimental group will receive a daily dose of 250 mg of TetraSOD® in a capsule during 90 days. After treatment, the group will stop consumption of TetraSOD® and a wash-out period of three months will start
15749512|NCT04864314|Dietary Supplement|Sham|Participants in the Control group will receive a daily dose of placebo in a capsule during 90 days. After treatment, the group will stop consumption of placebo and a wash-out period of three months will start
15749513|NCT04864301|Procedure|Tumescent Stretching Measurement Technique|"The Tumescent Stretching Measurement Technique (TSMT) group (N=12) will be administered an intracorporal injection (ICI) of 20 microgram Alprostadil. Hegar 7 dilator will be introduced through the corporotomy until reaching a bone stopping point. The tumescent penis will stretched maximally, and the proximally inserted dilator measured externally to the coronal sulcus."
15749514|NCT04864288|Device|Shear Wave Elastography|is a quantitative method in which the probe generates acoustic impulses through the tissue to create molecular vibration. These vibrations create shear waves so that elasticity might be calculated, because it is proportional to the speed of the waves
15749515|NCT04864262|Other|Photovoice|Photovoice is a method that uses photographs and dialogue to share experiences, understand an issue and promote positive change. Group meetings will be held four times throughout the photovoice intervention. The goals of the group meetings are to share knowledge about falls and fall prevention, identify commonalities in the issues raised by the participants, and discuss ways in which these issues could be addressed, both at individual and societal levels. For two photo assignments, participants will be asked to take 4-6 pictures for an assigned question. The question for photo assignment #1 will be 'What decreases your likelihood of falling?' The question for photo assignment #2 will be 'How do you reduce the risk of falling so that you can participate in meaningful activities?' Following each photo assignment, participants will complete an individual semi-structured interview with the peer mentor and the research trainee, who will have a background in physical or occupational therapy.
15749516|NCT04864249|Device|SNOO|The SNOO is a commercially available device which is a responsive bassinet for neonates. The bassinet is designed to respond to the infant's cries and automatically respond by emitting engineered white noise sounds and providing a rhythmic rocking motion. The infant is also swaddled to remain securely back-down. The SNOO automatically increases the emitted sound and motion if the infant is still crying. However, if the infant does not settle within 3 minutes, the SNOO will shut off and alert the adults for additional assistance. Parents can also modify the SNOO settings to meet the baby's need for sound and/or motion.
15749517|NCT04864249|Other|Safe sleep education in the postpartum period|Comprised of education from the postpartum clinical nurse with a corresponding educational handout to take home
15749518|NCT04864236|Device|Novel isolation device to contain aerosol|"The novel isolation device is called SLACC (Suction-assisted Local Aerosol Containment Chamber). SLACC has the ability to isolate the atmosphere around the patient's upper airway (nose, mouth, throat) via negative pressure in a manner analogous to isolation rooms used to house patients with communicable diseases spread by aerosol (e.g. tuberculosis).
~The SLACC uses an external suction source to maintain a negative pressure micro-atmosphere around a patient's head (the source of infectious aerosols). The components of SLACC include a clear polymer frame, a flexible drape, and integrated sealed arm sleeves to protect the hands and forearms of the health care provider. The structure is flexible during use, transparent, can be rapidly assembled, and easily collapsible for removal and transport. Once deployed with the patient's head inside the chamber, the drape is secured across the open side of the chamber with adhesive and covers the patient's torso."
15749519|NCT04864210|Drug|Liposomal bupivacaine|Surgeons will perform an intercostal nerve block in the operating room under thoracoscopic guidance while the patient is asleep under anesthesia. This intervention (block) is one of the standards of care but the medication (liposomal bupivacaine) currently is not FDA approved for this type of block.
15749520|NCT04864210|Drug|Bupivacaine|An anesthesiologist trained in regional anesthesia will perform a paravertebral block in the hospital's pain service unit. This intervention is standard of care and will use plain bupivacaine with epinephrine as the medication
15749521|NCT04864197|Biological|platelet rich fibrin|prf membrane placement over implant site for gingival thickening
15749522|NCT04864184|Behavioral|Normal physiologic rate breathing|2-minute breathing exercises will be completed every 15 minutes.
15749523|NCT04864184|Behavioral|Slow breathing|2-minute breathing exercises will be completed every 15 minutes.
15749524|NCT04864171|Device|near-infrared spectroscopy|Near-infrared spectroscopy is an intravascular imaging device to visualize lipid-rich plaque of coronary artery.
15749525|NCT04864158|Procedure|TSA-group|Reverse total shoulder arthroplasty followed by standard rehabilitation.
15749526|NCT04864158|Other|Exercise-group|The exercise-group will attend a 12-week exercise program with one weekly physiotherapist-supervised session supplemented with two weekly sessions of home-based exercises. Utilisation of a predefined training protocol describing procedures and content of each session secure uniformity and standardisation of the intervention. The exercise program consists of two warm-up exercises and five exercises that target shoulder range of motion and muscle strength. Furthermore, a link to a video, informing about glenohumeral osteoarthritis, the role of exercise and exercise related pain, will be sent to all patients in the exercise-group. The physiotherapists delivering the exercise intervention are not otherwise related to the trial.
15749562|NCT04863872|Behavioral|my hypo compass education program|Participants will be enrolled in a structured education program designed to improve hypoglycemia awareness and reduce severe hypoglycemia. The structured program will include 2 online group education sessions, 2 nurse follow up calls and use of glucose and hypoglycemia diaries, delivered over approximately 3 months.
15749527|NCT04864145|Device|Transcatheter Aortic Valve Implantation|The VitaFlow™ system (MicroPort®, Shanghai, China) was a novel TAVR system, which incorporates high-radial force and a double layer polyethylene terephthalate (PET) skirt to optimize frame geometry and minimize the risks of paravalvular leak (PVL). The VitaFlow™ transcatheter aortic valve is made of a self-expanding nitinol frame and tri-leaflet bovine pericardial valve.
15749528|NCT04864145|Drug|Medical therapy|Angiotensin-neprilysin inhibition (ARNI), diuretics, dihydropyridine calcium channel blocker, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor blockers (ARBs) or beta blockers.
15749529|NCT04864132|Diagnostic Test|6-minute walk test|This test assesses submaximal exercise capacity.
15749530|NCT04864132|Diagnostic Test|Incremental shuttle walk test|This test assesses maximal exercise capacity.
15749531|NCT04864106|Device|Endoscopic Examination|Endoscopic airway grading using a rigid 75-degree angle laryngoscope.
15749532|NCT04864093|Diagnostic Test|muscular ultrasound|respiratroy and muscular ultrasound
15749533|NCT04864080|Behavioral|Computer game/task|N-back, COGED, PacMan game, Bandit task, Websurf task.
15749534|NCT04864080|Behavioral|Health surveys online|Health surveys to study themes like pain, sleep, depression and anxiety, and PTSD.
15749535|NCT04864067|Drug|Oxaliplatin|Consolidation Chemotherapy
15749536|NCT04864067|Drug|5-Fluoracil|Consolidation Chemotherapy
15749537|NCT04864067|Drug|Leucovorin|Consolidation Chemotherapy
15749538|NCT04864067|Drug|Capecitabine|Consolidation Chemotherapy
15749539|NCT04864067|Radiation|5x5 Gy|Neoadjuvant Radiotherapy
15749540|NCT04864067|Behavioral|Quality of Life Questionnaires|Quality of Life Evaluation (LARS Score, IIEF, FSFI, I-PSS and EORTC QLQ-C30)
15749541|NCT04864067|Procedure|DRE/ Endoscopy|Flexible Sigmoidoscopy and Digital Rectal Exam
15749542|NCT04864054|Biological|ECT204 T cells|ECT204 is an autologous T-cell therapy whereby a subject's own T cells are transduced with a lentiviral vector expressing the ECT204 transgene.
15749543|NCT04864041|Other|Evaluation of global longitudinal strain using routinely recorded echocardiography images|There are no particular intervention performed in patients in this study, because echocardiography is part of the standard of care of patients hospitalised in the ICU for vaso occlusive crisis.
15749544|NCT04864028|Other|physical activity|15min sitting, 15min standing, 15min sitting, 15 min low intensity cycling
15749545|NCT04864015|Device|Mouthpiece B1(Mouthpiece MPC-ST GMDN:62534 Generic name: Endoscopic bite block, basic, reusable|Use of a Mouthpiece B1 during standard EGD instead of a conventional mouthpiece
15749546|NCT04864002|Other|No intervention. only observational cross sectional study|No intervention done. only observational cross sectional study
15749547|NCT04863989|Procedure|tube thoracostomy|insertion of intercostal tube for drainage of traumatic hemothorax or pneumothorax
15749548|NCT04863976|Other|Dynamic stretching|Dynamic movements of the joints controlled by the quadriceps muscle (hip and knee)
15749549|NCT04863976|Other|Passive stretching|passive stretching of the quadriceps muscle
15749550|NCT04863976|Other|Self-stretching|Self-stretching of the quadriceps muscle
15749551|NCT04863963|Procedure|Milligan Morgan|Surgical intervention used in case of Goligher's grade III hemorrhoidal disease
15749554|NCT04863937|Device|Distal Thigh Compression Garment, Knee Sleeve|Randomized Comparison of Knee Sleeve, Distal Thigh Compression Garment and No Device
15749555|NCT04863924|Diagnostic Test|Liquid Biopsy|All patients will have a liquid biopsy with ctDNA molecular profiling
15749556|NCT04863911|Radiation|combined CT and MRI|"1 mL of gadolinium-diethylenetriamine pentaacetic acid (Gd-DTPA) will be diluted with 100 mL of saline; 8 mL of this will be mixed with 7 mL of iodine solution (340 mg/cc) and 3 mL of lidocaine 2% and injected under ultrasonographic guidance.
~The fixed US-guided technique, the needle will be inserted into the needle guide hole and directed toward the hip joint, targeting the femoral head-neck junction. The volume injected varies from 10 to 20 mL, with a mean of 15 mL.
~Ideally CT should be performed immediately after the injection and MR should be performed within 90 minutes after the initial injection."
15749557|NCT04863898|Behavioral|Drug-use stigma reduction intervention for HIV care and treatment clinics|We will adapt the HP+ health facility HIV stigma-reduction intervention to focus on drug stigma in HIV care and treatment clinics (CTCs). The intervention will address key stigma drivers, including fear, awareness of stigma, and stigmatizing attitudes and beliefs, through a participatory training approach that involves all levels of staff and is grounded in social cognitive theory principles. The approach seeks to reduce stigma through fostering empathy, interpersonal interactions (contact strategies) and building efficacy for stigma reduction through awareness, skills, and knowledge building. The intervention consists of four-3 hour participatory training sessions.
15749558|NCT04863885|Drug|Ipilimumab|Participants will receive Ipilimumab 3 mg/kg
15749559|NCT04863885|Drug|Nivolumab|Participants will receive Nivoumab 1mg/kg
15749560|NCT04863885|Drug|Sacituzumab govitecan|Participants will be treated at 1 of 2 dose levels of Sacituzumab govitecan, either at 8 mg/kg, 10 mg/kg, or 6 mg/kg.
15749561|NCT04863872|Other|Proactive Care Management|Participants will receive one telephone nurse outreach call with follow up by the nurse or their primary care provider as clinically indicated.
15786587|NCT04559971|Drug|Placebo|Sodium chloride for s.c. injection
15749563|NCT04863846|Other|No intervention, observational study|Exposure of interest: clinical implementation of an algorithm
15749564|NCT04863820|Diagnostic Test|cutaneous silent period|form of Nerve conduction studies
15749565|NCT04863807|Procedure|Regional Anaesthesia|Thoracic epidural/Erector Spinae block/Serratus Anterior block
15749566|NCT04863794|Drug|RO7248824|A single dose of 10 mg RO7248824 will be used for this PET study in healthy participants.
15749567|NCT04863781|Behavioral|Mobile cognitive-behavioral stress management intervention|Each weekly module will consist of a cognitive component and a relaxation component. The cognitive component during the first 3 weeks will educate users about the Transactional Model of Stress, that discrimination is a type of stressor, and the impact of stress on health. Building on this information, users will then learn how to match coping responses to the changeability of stressors during weeks 4 and 5. The cognitive component will conclude by focusing on the four most common coping strategies used by African American women in response to stress. Modules 2 through 4 will teach progressive muscle relaxation through a series of tension and relaxation cycles. Modules 5 through 8 will train users in diaphragmatic breathing. Finally, users will be trained in three types of mindfulness mediations.
15749568|NCT04863781|Behavioral|Control|The introductory course defines stress, describes the different sources of stress, and the influence of personality on stress. The coping module includes training in cognitive coping skills, guided imagery, progressive relaxation, autogenic training, and the importance of physical activity to manage stress. All lessons include course assessments. During the intervention period, controls will receive weekly text messages encouraging completion of material.
15749569|NCT04863768|Diagnostic Test|Gene panel|comprehensive cancer gene panel targeting regions in 37 clinically relevant cancer genes in FFPE tumor tissue blocks
15749570|NCT04863755|Behavioral|DASH|Patients receive DASH diet orientation and recommended to maintain their usual physical activity
15749571|NCT04863755|Behavioral|DASHPED|Patients receive DASH diet orientation and recommended to increase their usual activity with the use of a pedometer
15749572|NCT04863742|Drug|Dextenza 0.4Mg Ophthalmic Insert|sustained released dexamethasone, 0.4mg
15749573|NCT04863742|Drug|Prednisolone Acetate|Prednisolone Acetate 1% QID x 1week, TID x 1week, BID x1 week, QD x1 week.
15749574|NCT04863729|Behavioral|Asdzaan Be'eena Program|"The program consists of 11 weekly sessions conducted with girls ages 10-14 and their female caregivers. 5 of the 11 sessions will be taught to groups of 9-13 girls and their female caregivers, and 6 of the sessions will be taught to individual girl/female caregiver dyads. The choice to use a mix of group- and individual sessions is based on findings from the formative phase indicating certain topics should be taught in groups (e.g. Navajo history and reproductive health 101), and certain topics be taught in individual dyads (e.g. family values and the clan system).
~Each of the sessions (group and individual) will be 60-90 minutes in duration and delivered by a trained Family Health Coach (FHC). Group sessions will take place at a local community center in a private room. Individual dyad sessions will take place in the girls'/female caregivers' home or another private place of their choosing, such as our local Johns Hopkins offices."
15749575|NCT04863716|Procedure|Erector Spinae Plane Block|Erector Spinae Plane Block will be administered before the surgery.
15749576|NCT04863716|Procedure|Intravenous fentanyl patient control device|24-hour fentanyl consumption will be recorded.
15749577|NCT04863703|Drug|Bulevirtide|Patients with liver cirrhosis and HBV/HDV coinfection receive Bulevirtide as an antiviral therapy irrespective of the study, this study is observational.
15749578|NCT04863690|Behavioral|Meditation|Participants will be asked to use either the Muse Mind Meditation, Muse Sleep Journeys, Go to Sleep Soundscapes or Go to Sleep Guidance each evening as part of their bedtime routine to help them prepare to sleep. In addition, participants may use any part of the Muse App (Mind, Heart, Breath, Body, Guided or Go to Sleep meditations, as often as they like to help them fall asleep, go back to sleep, or as a meditation practice during the daytime. All Participants will also be asked to do the Muse Mind meditation for a minimum of 5 minutes per day, a minimum of 5 days per week, for 6 weeks. If they also wish to use the Muse system more frequently (day or night), they will be encouraged to do so and will be able to choose between several styles of available meditation (Mind, Heart, Breath, Body, Guided or Go to Sleep meditations). Participants will be asked to also wear their Muse device while they sleep, as often as they like in order to track their sleep.
15749579|NCT04863690|Behavioral|Digital Coaching|All participants will work through the content in the Muse S Sleep Coaching course, and implement the sleep hygiene and habit changes recommended through the course that they find reasonable and effective for their situation.
15749580|NCT04863690|Behavioral|Digital Coaching plus Human Coaching|All participants will work through the content in the Muse S Sleep Coaching course, and implement the sleep hygiene and habit changes recommended through the course that they find reasonable and effective for their situation. All participants will also be asked to join regular online coaching sessions. Participants will be divided into 9 cohorts of 10 people per cohort. Each cohort will be offered group coaching once per week. Coaches will be versed in Mindfulness, and how to use Muse and how to support sleep. Coaching will take place virtually using Interaxon's Zoom account.
15749581|NCT04863677|Behavioral|High Intensity Interval Training(HIIT）|Last 12 weeks (3 sessions per week)
15749582|NCT04863677|Behavioral|Moderate Intensity Continuous Training(MICT）|Moderate Intensity Continuous Training(MICT）
15749584|NCT04863638|Biological|3-doses schedule 1 of COVID-19 Vaccine (Vero Cell), Inactivated|the schedule of Day 0, 21, 42
15749585|NCT04863638|Biological|3-doses schedule 2 of COVID-19 Vaccine (Vero Cell), Inactivated|the schedule of Day 0, 21, 111
15749586|NCT04863638|Biological|3-doses schedule 3 of COVID-19 Vaccine (Vero Cell), Inactivated|the schedule of Day 0, 21, 171
15749587|NCT04863638|Biological|2 doses of vaccine|the schedule of Day 0, 21
15749627|NCT04863248|Drug|Docetaxel|Docetaxel administered IV on Day 1 of each 21-day cycle.
15749628|NCT04863235|Behavioral|Control Group|Eight week behavioural change program aimed to increase physical activity plus information on general health topics among individuals with prediabetes.
15749629|NCT04863235|Behavioral|Intervention Group|Eight week behavioural change program plus a self-compassion intervention aimed to increase physical activity among individuals with prediabetes.
15791315|NCT04522375|Drug|FP-045|activator of aldehyde dehydrogenase
15749588|NCT04863625|Behavioral|a peer-led educational intervention based on theory of planned behavior on substance use intentions and behaviors|The intervention will be a peer led education process on substance use (smoking, drinking and chewing) prevention based on the Theory of Planned Behavior (TPB).The intervention aims to encourage anti-substance attitudes and beliefs; foster perceptions of normative support for anti-substance behavior; increase perceptions of control/self-efficacy to resist substance use, increase knowledge and risk perceptions on substance and decrease in intention to use substance and actual substance use behaviors. Six education sessions will be delivered, with one session occurring each week. Each session will be lasted 40-55 minutes. The intervention will be conducted in 30 groups of selected students from grade 9-12, a pair of peer educators will educate a 30 sized group weekly (30 students /group)/ classrooms at pre-assigned time during class periods. The six sessions will be guided by four student training modules.
15749589|NCT04863599|Other|Questionnaire|Patients will be asked to complete the Bauer and Brice questionnaire at post-operative day 1.
15749590|NCT04863560|Other|Auditory Cueing|Metronome beat to step in time with
15749591|NCT04863560|Other|Visual Cueing|Lines on the floor to step over
15749592|NCT04863560|Other|tactile Cueing|Vibration to step in time with (metronome like)
15749593|NCT04863547|Other|Data collection|Data collection
15749594|NCT04863534|Device|Ultrasound|Muscular grayscale ultrasound
15749595|NCT04863521|Other|MHP|MyHealthyPregnancy app (MHP 3.0) is an mHealth app specifically focused on detection and referral for depression and IPV risk, in addition to its other pregnancy risk detection and support features.
15749596|NCT04863482|Procedure|IOC|intra-operative cholangiography near-infrared fluorescence cholangiography
15749597|NCT04863469|Behavioral|B-POC high load intervention|aerobic exercise [heartrate range (HRR) 70-75% of max HR, on spin bike] and a computerized high-load task for 60 minutes, 3 times per week, for 6 weeks
15749598|NCT04863469|Behavioral|B-POC low load intervention|aerobic exercise [heartrate range (HRR) 70-75% of max HR, on spin bike] and a computerized low-load task for 60 minutes, 3 times per week, for 6 weeks
15749599|NCT04863456|Procedure|Total resection|Total resection of HIPA in a single surgery
15749600|NCT04863456|Procedure|Staged resection|HIPA was resected subtotally at first time, and the tumor remnant was removed at a later date
15749601|NCT04863456|Procedure|Subtotal resection followed by stereotactic radiation therapy|HIPA was resected subtotally at first time, and the tumor remnant was controled by the stereotactic radiation therapy
15749602|NCT04863443|Device|Ultrasound|ultrasound scanner to collect sonographic imaging data from the breast
15749603|NCT04863430|Drug|Apatinib|500mg oral qd
15749604|NCT04863430|Drug|Oxaliplatin|130mg/m^2 administered as IV infusion on Days 1 of each 21-day cycle
15749605|NCT04863430|Drug|S1|According to body surface area,(<1.5m^2) 40mg or (≥1.5m^2)50mg bid oral on Day 1-14 of each 21-day cycle
15749606|NCT04863417|Drug|PF-07038124 or vehicle|PF-07038124 0.01% or vehicle Ointment QD applied to 2000 cm2 Body Surface Area
15749607|NCT04863417|Drug|PF-07038124 or vehicle|PF-07038124 0.01% or vehicle Ointment QD applied to 4000 cm2 Body Surface Area
15749608|NCT04863404|Other|Face mask with hybrid-hyrax|Face mask with hybrid-hyrax
15749609|NCT04863404|Other|Face mask with conventional bonded RME|Face mask with conventional bonded RME
15749610|NCT04863391|Diagnostic Test|Referrable versus Non Referral AMD diagnostic test|Artificial intelligence read reports Referrable versus Non Referral AMD
15749611|NCT04863378|Behavioral|Walking conversational reminiscence|Triadic walking with prompted conversational reminiscence
15749612|NCT04863365|Drug|Placebo ophthalmic solution|A matching placebo ophthalmic solution, 3 drops daily, 28 days
15749613|NCT04863365|Drug|PHP-201 ophthalmic solution|PHP-201 0.5% ophthalmic solution, 3 drops daily, 28 days
15749614|NCT04863339|Drug|Tranexamic acid|Single preoperative dose of 1 gram of Tranexamic Acid in 100 mL of saline given 0-30 minutes prior to surgery.
15749615|NCT04863339|Drug|Placebo|Single preoperative dose of 100 mL of saline placebo given 0-30 minutes prior to surgery.
15749616|NCT04863326|Behavioral|Making Proud Choices|
15749617|NCT04863326|Behavioral|Business as usual|
15749618|NCT04863313|Dietary Supplement|Probiotic|Experimental group will consume one probiotic capsule every day during 12 weeks at breakfast.
15749619|NCT04863313|Dietary Supplement|Placebo|Placebo group will consume one placebo capsule every day during 12 weeks at breakfast.
15749620|NCT04863300|Behavioral|Collaborative stepped care and peer support|"Case identification will be done through open referral and outreach activities such as street booth, talks, and home visits.
~For older adults with mild depressive symptoms (PHQ-9 score 5-9), 6-8 weeks of indicated prevention with psychoeducation or low-intensity psychotherapy would be provided by the project social workers in DECC. For participants with moderate depressive symptoms (PHQ-9 score 10-14), 6-8 weeks high-intensity clinical intervention, mainly group cognitive behavioral therapy (CBT), would be provided by project social workers from DECC and ICCMW. For those with moderately severe depressive symptoms (PHQ-9 score 15-19), 8-10 weeks individual CBT or group CBT at higher frequency would be provided by the project social workers from ICCMW.
~In the progress review when a client is assessed to meet the discharge criteria, a 2-month exit plan involving a Peer Supporter follow-up is invoked."
15749621|NCT04863287|Biological|2217LS|Fully Human Monoclonal Antibody
15749622|NCT04863287|Other|0.9% Sodium Chloride (NaCl)|Subcutaneous injection
15749623|NCT04863274|Drug|atorvastatin|"Profound patients' consultations (different from standard practice) on the importance of primary prevention of cardiovascular diseases, including preventive administration of statins.
~Subjects in profound consultation group will receive regular reminders (2 times a month) via SMS and phone calls to check following the doctor's recommendations and remind about follow-up visit to study centre."
15749625|NCT04863248|Drug|Trilaciclib|Trilaciclib administered IV over 30 minutes prior to docetaxel IV on Day 1 of each 21-day cycle.
15749626|NCT04863248|Drug|Placebo|Placebo administered IV over 30 minutes prior to docetaxel IV on Day 1 of each 21-day cycle.
15749630|NCT04863222|Biological|Biodentine|During a patients procedure, one tooth will receive Biodentine instead of MTA.
15749631|NCT04863222|Other|mineral trioxide aggregate (MTA)|mineral trioxide aggregate (MTA)
15749632|NCT04863209|Other|Upper cervical manipulation|The patient will receive an upper cervical manipulation as described in the Experimental Group 1.
15749633|NCT04863209|Other|Sphenopalatine ganglion manipulation|The patient will receive a sphenopalatine ganglion as described in the Experimental Group 2.
15749634|NCT04863196|Other|Laser therapy Treatment Group|laser in gastric mucosa lesion
15749635|NCT04863196|Other|Barrier Dust Treatment Group|barrier powder in gastric mucosa lesion
15749636|NCT04863183|Biological|CELLISTEM-OA|The intra-articular puncture will be performed by an orthopedic doctor specializing in knee and hip treatments. The procedure will be carried out using sterile technique, after cooling the skin with local ice.
15749637|NCT04863183|Drug|Triamcinolone acetonide|The intra-articular puncture will be performed by an orthopedic doctor specializing in knee and hip treatments. The procedure will be carried out using sterile technique, after cooling the skin with local ice.
15749638|NCT04863170|Procedure|orthognathic surgery|surgical intervention of the maxilla and / or mandible that includes orthodontic treatment before and after surgery
15749639|NCT04863157|Behavioral|Survivor-SHIP|Parent/guardian education about healthy sleep practices to improve their child's sleep health.
15749640|NCT04863144|Other|Blood samples|Plasma concentrations of paclitaxel and its metabolites will be obtained during the first treatment cycle. The samples for paclitaxel analysis will be collected in ethylenediamine tetraacetic acid tubes at 7-time points: just before infusion, in the middle of the infusion, at the end of infusion, at 1, 2, 4 and 6 hours post-infusion.
15749641|NCT04863131|Biological|EXG-5003|COVID-19 self-replicating mRNA vaccine
15749642|NCT04863131|Biological|Placebo|placebo solution
15749643|NCT04863118|Other|Strength training in shallow water and dry land|"Dry land: The intervention will last for 60 minutes, consisting of exercises to strengthen the global extensor musculature, that is, involving the upper limbs, trunk and lower limbs. Weights and equipment for strength training will be used. The sessions will start with 10 minutes of warm-up, the central part of exercises to strengthen the extensor muscles and the last part will consist of oriented stretches. In the central part, a typical strength training will be performed (2-6 series; 85% of RM), using submaximal subjective effort and with repetition control.
~Shallow water: The intervention performed on dry land will be adapted and produced in an aquatic environment. Aquatic implements will be used for strength training."
15749644|NCT04863118|Other|High-intensity training in shallow and deep water|"Shallow water: The intervention will last 60 minutes. The exercises consist of: immersion, balance, strength, agility and displacement in the water. As they will start with 10 minutes of warm-up and the last part will consist of stretches oriented along the edge of the pool and on the depth reduction platform. In the main part of the intervention, different styles of exercises will be performed, with or without the use of implements. Displacements will have varying speeds in the same session, defined by Borg's Scale of subjective sensation of effort.
~Deep water: The intervention carried out in shallow water will be adapted with the use of floating belts and reproduced in deep water."
15749645|NCT04863105|Drug|Abiraterone acetate tablets(Zecke ®250 mg);Abiraterone acetate tablets(250 mg)|"Subjects were allocated to one of three groups randomly and equally with a 7-day washout interval between the two periods.Abiraterone acetate tablets(Zecke ® 250 mg,Batch number:VYCB manufactured by Patheon Inc.)and Abiraterone acetate tablets(250 mg,Batch number:17F0023DD9 manufactured by Qilu Pharmaceutical Co., Ltd) were used in this study."
15749646|NCT04863092|Behavioral|Educational Intervention|The workshops will last approximately 60 minutes, with 20 minutes to educate participants and 10 minutes to discuss the materials and answer any questions. Prior to and after the presentation, the CHE will administer the pre- and post-intervention survey to participants. Group sizes will be capped to 25 individuals per group.
15749647|NCT04863079|Drug|Pembrolizumab Injection [Keytruda]|Pembrolizumab 200 mg IV, Q3W, up to one year or disease progression or intolerance.
15749648|NCT04863066|Biological|CAR-T cells|The presence of latent infected cells remains a key barrier to HIV-1 functional cure. Current approach to reducing the latent HIV reservoir is to reactivate virus-containing cells to make them be detected and eliminated by host defense. Endogenous cytotoxic T-lymphocytes (CTL) may not be adequate because of cellular exhaustion and immune escape of virus. We have designed a kind of CAR-T cell based on CTL engineered to express a scFv of a broadly neutralizing anti-HIV antibody. According to our preclinical studies, CAR-T cells strongly eradicated HIV-1-infected target cells making them a particularly suitable candidate to reach a functional HIV cure. In this clinical trial, we mainly intend to evaluate the safety of CAR-T-Cell therapy on HIV patients whose plasma HIV has been successfully suppressed after antiviral therapy.
15749649|NCT04863053|Other|Blood samples will be taken to assess platelet function. There is no change in treatment.|
15749650|NCT04863040|Behavioral|MOVI intervention|"Each HIIT break will last approximately 5 minutes and will not require any specific materials. The structure of the HIIT-Rest will be as follows: 1' to describe the work to be done; 3' of work following the HIIT protocol: 6 repetitions of a functional movement such as squats, Jumping Jack or running on site for 10 at high intensity (85-90% of HR max) followed by 20 of recovery (65-75% of HR max); and 1' to perform a return to calm in order to lower the activation and prepare the student body to return to class activities. To increase the workload, and after evaluation of cardiorespiratory capacity, after 12 weeks of program, the HIIT protocol will be changed to 20 of high intensity work alternating with 10 of recovery."
15749651|NCT04863027|Radiation|Thoracic radiotherapy|Patients will have pre-treatment and post-treatment perfusion DECT for baseline and post-treatment lung function
15749652|NCT04863014|Drug|evinacumab|Intravenous infusion every 4 weeks (Q4W)
15749653|NCT04863014|Other|Placebo|Intravenous infusion Q4W
15749654|NCT04863001|Drug|Antiarrhythmic drug|all classes of antiarrhythmic drugs used in pediatrics cardiology unit assiut university
15749655|NCT04862975|Drug|Dolutegravir|Dolutegravir will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider. Not prescribed for this study.
15749656|NCT04862975|Drug|Efavirenz|Efavirenz will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider. Not prescribed for this study.
15749748|NCT04862273|Diagnostic Test|Laboratory screening for multiple myeloma / AL amyloidosis|Reference method
15749657|NCT04862975|Drug|Emtricitabine|Emtricitabine will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider. Not prescribed for this study.
15749658|NCT04862975|Drug|Tenofovir Disoproxil Fumarate|Tenofovir Disoproxil Fumarate will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider. Not prescribed for this study.
15749659|NCT04862962|Drug|Rosuvastatin 10 or 20mg /Ezetimibe 10 mg Fixed Dose|Oral Tablets 10 mg/10 mg or 20 mg/10 mg
15749660|NCT04862949|Drug|Atezolizumab plus bevacizumab|Atezolizumab plus bevacizumab
15749661|NCT04862923|Drug|Oral semaglutide|Patients will be treated with commercially available oral semaglutide according to local label and to routine clinical practice at the discretion of the treating physician. The decision to treat the participant with a given product is independent of the decision to include him/her in the study.
15749662|NCT04862910|Other|Kinect Based Virtual Reality Training|"STEP I: The participant will receive the game instructions from the examiner. STEP-II: Warm Up (Walk on Treadmill for 5 Minutes) STEP III: The participant will play the games under the supervision of the researcher.
~Kinect games Kinect Sports Kinect Adventures Your Shape Fitness Evolved Three treatment sessions per week will be given to each participant. Total duration of each treatment session will be 45 Minutes. Routine Medication and routine diet will be continued."
15749663|NCT04862910|Other|Control Group|"They will be educated that Moderate-level regular physical activity can significantly impact the maintenance of bone density.
~They will continue their daily activities with a routine diet and routine Medication"
15749665|NCT04862884|Drug|HRS4800 tablets|"Drug: HRS4800 tablets Low-dose group, single oral administration
~Drug: HRS4800 tablets Low-medium dose group, single oral administration
~Drug: HRS4800 tablets medium -dose group, single oral administration
~Drug: HRS4800 tablets Medium and high dose group, single oral administration
~Drug: HRS4800 tablets High-dose group, single oral administration"
15749666|NCT04862884|Drug|placebo|"Drug: placebo Low-dose group, single oral administration
~Drug: placebo Low-medium dose group, single oral administration
~Drug: placebo medium -dose group, single oral administration
~Drug: placebo Medium and high dose group, single oral administration
~Drug: placebo High-dose group, single oral administration"
15749667|NCT04862871|Behavioral|Physical Activity - Pediatric Pain Rehabilitation Center|While admitted to the Pediatric Pain Rehabilitation Center program, patients receive 1-3 hours of individual and group physical therapy 5 times per week and completed a 30-60 minute home exercise program 9 times per week. The median length of stay for the program is 5 weeks. The amount of aerobic exercise prescribed is individualized to each patient and ranged from 10-20 minutes per session. The duration of aerobic exercise prescribed progressed by 5-10 min weekly until the child reached 20-30 minutes. Patients are instructed to reach a moderate to vigorous intensity of exercise (defined at 5-7/10 rate of perceived exertion). The mode of exercise varied dependent on patient ability and interest. Typical modes of exercise included: walking, running, stationary biking, swimming, sports (i.e., soccer, dance), and online aerobic workouts. Patients were prescribed an individualized 30-60 minute discharge home program using the same structure upon completing the program.
15749668|NCT04862858|Other|Educational Intervention|The educational intervention will involve guideline-based treatment recommendation information for providers via fax/mail and phone and provide resources via mail and phone for patients to learn more about ways to reduce their cardiovascular risk.
15749669|NCT04862845|Drug|Duloxetine and Pregabalin|will be received pregabalin with duloxetine 90 minutes preoperatively, then pregabalin every 12 hours with duloxetine once daily postoperatively until the fifth postoperative day.
15749670|NCT04862845|Drug|pregabalin|received pregabalin with a placebo capsule at 90 minutes preoperatively, then every 12 hours postoperatively with a placebo capsule once daily until the fifth postoperative day.
15749671|NCT04862845|Drug|sham|received two placebo capsules at 90 minutes preoperatively then placebo capsules every 12 hours, with one capsule daily postoperatively until the fifth postoperative day.
15749672|NCT04862832|Other|Music intervention|"The cold pressor test will consist in the immersion of the participants' arm in 10 degrees circulating water for two minutes.
~The music sequences will be all 20 minutes, instrumental, professionally recorded in the studio and composed specifically for the Music Care application and are thus unfamiliar to participants. There will be two music conditions: the most-liked-music (MLM) and least-liked-music (LLM) conditions."
15749673|NCT04862819|Drug|new local drug delivery|In the first group, on one side of the dental arch, the drug under evaluation will be used, and on the other side srp
15749674|NCT04862819|Procedure|scaling root planing|In the second group, on one side of the dental arch srp will be performed
15749675|NCT04862806|Diagnostic Test|COVID-19 serology|Immune response to BNT162b2 mRNA vaccine is assessed on the basis of anti covid19 IgG levels. A centralized assessment of the serological response for 4 medical centers is performed on serum samples stored at -60 °C using Abbott-SARS-CoV-2 IgG quant (Positive value > 151; range 0-40.000). The other 4 medical centers performed the test locally using DiaSorins-LAISISON SARS-CoV S1/S2 IgG test (positive value >15 range 15-400). In the central virus laboratory at the Chaim Sheba Medical center the test was done by Elisa-RDB (positive value >1.1; range 1.1-10).
15749676|NCT04862793|Device|Colonoscopy Progression Score (CoPS)|The Colonoscopy Progression Score consists of five different aspects: Travel length, Tip progression, chase efficiency, shaft movement without tip progression and looping.
15749677|NCT04862793|Device|Colonoscopy Retraction Score (CoRS)|The Colonoscopy Retraction Score consists of three different aspects: Tip Retraction, Retraction Efficiency, and Retraction Distance.
15749678|NCT04862780|Drug|BLU-945|Oral administration
15749679|NCT04862767|Drug|TASO-001((TGF-β2 targeting anti-sense oligonucleotide)|96 hour continuous infusion
15749680|NCT04862767|Combination Product|Aldesleukin|SC, Bid
15749681|NCT04862754|Other|interval training exercise|interval training exercise
15749682|NCT04862741|Drug|NX-13 250mg IR|Subjects will take study drug by ingesting one tablet per day, recommended at the same time in the morning for consistency. Subjects in a NX-13 group will receive either 250 mg or 500 mg of NX-13 in an immediate release or modified release tablet and subjects in the placebo group will receive matched placebo.
15749749|NCT04862273|Procedure|Cardiac biopsy|If non-invasive tests for CA (99mTc-DPD scintigraphy, biochemistry) are inconclusive
15749683|NCT04862741|Drug|NX-13 500mg IR|Subjects will take study drug by ingesting one tablet per day, recommended at the same time in the morning for consistency. Subjects in a NX-13 group will receive either 250 mg or 500 mg of NX-13 in an immediate release or modified release tablet and subjects in the placebo group will receive matched placebo.
15749684|NCT04862741|Drug|NX-13 500mg MR|Subjects will take study drug by ingesting one tablet per day, recommended at the same time in the morning for consistency. Subjects in a NX-13 group will receive either 250 mg or 500 mg of NX-13 in an immediate release or modified release tablet and subjects in the placebo group will receive matched placebo.
15749685|NCT04862741|Drug|Placebo|Subjects will take study drug by ingesting one tablet per day, recommended at the same time in the morning for consistency. Subjects in a NX-13 group will receive either 250 mg or 500 mg of NX-13 in an immediate release or modified release tablet and subjects in the placebo group will receive matched placebo.
15749686|NCT04862728|Other|- Strong kids screening tool - Stamp screening tool - PYMS screening tool|Screening Tool for the Assessment of Malnutrition in Pediatrics (STAMP) evaluates patient's clinical diagnosis, nutritional intake during hospitalization and anthropometric measurements, developing a care plan based on the child's overall malnutrition risk (low, medium or high).Screening Tool for Impaired Nutritional Status and Growth (STRONG kids). It consists of four items: subjective clinical assessment, high-risk diseases, nutritional intake and losses, weight loss or poor weight gain. Patients classified at high nutritional risk have a longer hospitalization and a negative standard deviation score (SDS) for weight-for-height (WFH), which indicated a state of acute malnutrition.The Pediatric Yorkhill Malnutrition Score (PYMS) is adopted among medical and surgical patients between 1 and 16 years of age. The PYMS assesses four items: BMI, history of recent weight loss,
15749687|NCT04862715|Drug|Ferinject|"Active study medication Medication name: Ferinject® Active ingredient: Ferric carboxymaltose Dosage form: 50 mg iron/ml solution for injection/infusion. Appearance: Dark brown, non-transparent aqueous solution Excipients: Sodium hydroxide, hydrochloric acid and water for injection Strength/Packaging: Each 2 ml vial contains 100 mg of iron as ferric carboxymaltose.
~Each 10 ml vial contains 500 mg of iron as ferric carboxymaltose. Each 20 ml vial contains 1,000 mg of iron as ferric carboxymaltose. Manufacturer: Vifor Pharma UK Limited"
15749688|NCT04862715|Other|Placebo: NaCl (sodium chloride 0.9%)|Medication name: NaCl (sodium chloride 0.9%) Active ingredient: NaCl (sodium chloride 0.9%) Dosage form: 0.9% w/v NaCl as sterile solution in water for injection Excipients: Water Strength/Packaging: 100 ml container with 100 ml normal saline Manufacturer: As per local hospital supplier
15749689|NCT04862702|Device|mechanical instrumentation using rotary file system|the mechanical preparation will be performed using rotary file system
15749690|NCT04862689|Device|Ringer Perfusion Balloon Catheter|Non-emergent Percutaneous Coronary Intervention (PCI) for treatment of a coronary artery lesion with Ringer Perfusion Balloon Catheter.
15749691|NCT04862676|Drug|Hyperbaric oxygen|The treatment consists of exposure to hyperbaric oxygen at 2.5 atmospheric absolutes (ATA) for a total of 90 minutes after compression to 2.5 atmosphere absolutes (ATA) in a monoplace hyperbaric chamber breathing 100% oxygen. The subjects will be in the chamber for a total of 120 minutes as approximately 10-15 minutes are spent during the compression and decompression phases and subjects have 5-10 minute room air breaks every 30 minutes of hyperbaric oxygen treatment.
15749692|NCT04862663|Drug|Capivasertib|Phase Ib: potential range 200 mg, 320 mg, 400 mg, all BD. Days 1 to 4 in each week of a 28-day treatment cycle Phase III: 400 mg (BD 4 days on 3 days off/week for 4 weeks), depending on tolerability observed in Phase Ib
15749693|NCT04862663|Drug|Capivasertib Placebo|Phase Ib: Not applicable Phase III: 400 mg (BD 4 days on 3 days off/week for 4 weeks), depending on tolerability observed in Phase Ib
15749694|NCT04862663|Drug|Fulvestrant|Phase Ib and Phase III: 500 mg (2 injections of 250 mg) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter
15749695|NCT04862663|Drug|Palbociclib|Phase Ib: potential range 75 mg, 100 mg, 125 mg. Once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete 28-day cycle Phase III: 125 mg (OD 21 days of 28- day cycle), depending on tolerability observed in Phase Ib
15749696|NCT04862650|Drug|Carboplatin|Given IV
15749697|NCT04862650|Biological|Cemiplimab|Given IV
15749698|NCT04862650|Drug|Paclitaxel|Given IV
15749699|NCT04862637|Procedure|pull through group|pull through method
15749700|NCT04862637|Procedure|mandibular-lip split group|traditional mandibular-lip split method
15749701|NCT04862624|Behavioral|Catalina Story-Based Web-App|"Latinas in the experimental group will view a story-based web-app featuring a character named Catalina and psycho-therapeutic modules to motivate them to take action and get help for their symptoms of depression and/or anxiety."
15749702|NCT04862624|Behavioral|Attention Control Web-App|Latinas in the attention control group will view non-story based media that is informational.
15749703|NCT04862598|Device|Oculus Virtual Reality|The patient will receive standard care, augmented with virtual reality. Their post-operative satisfaction score will be recorded.
15749711|NCT04862572|Other|MRI scanning|"In the audiological assessment, participants will undergo various audiometric test, such as pure tone audiometry with extended high-frequency range, speech audiometry, tympanometry, and auditory reflex threshold. These tests are all noninvasive and aim to assess participants hearing threshold, speech-in-noise difficulty, whether or not they have conductive hearing loss, and test efferent auditory function. The appointment will take around 60-90 minutes. An experienced audiologist on-site will be in charge of this procedure.
~In the MRI appointment, participant will undergo MRI scanning. Before the MRI scan, a researcher with experienced radiographer will re-check that the participant is safe to be scanned, with the standard University of Nottingham safety questionnaire. This rechecking step is necessary to make sure that participants are still eligible for the scanning. An experience radiographer will be in charge of this procedure."
15749712|NCT04862559|Device|NovaCross|A device that is intended to asisst interventional cardiologists during catheterization to cross and open coronary chronic total occlusions
15749713|NCT04862546|Device|Laser Acupoint|Step 1: The subject was in sitting position and exposure area for applying laser then therapist use tap measurement to find the point. Parameters was used in this study : PROBE :ML A1\25 TIME:01:00 FREQUENCY: 10000Hz (25mw), DUTY-CYCLE:100% DENESITY: 1J\CM2 AREA :1CM2 Step 2: Apply laser on acupuncture points by using 10000HZ for 1 minute for every point. Totally cession: 10 minutes Step 3: ensure that all point done Repeat all steps for every subject
15749714|NCT04862546|Device|Tap water iontophoresis|"Enough tap water is placed in the pans, then the generator is plugged in and switched on. After that, the patient's hands are placed in the pans.
~The treatment is administrated by slowly increased intensity to tell the patient to feel a tingling sensation or up to 20 milliamperes and continue with this polarity for 10 minutes. After that, the polarity reversed and intensity increased again to the desired level for another 10 minutes."
15749715|NCT04862533|Drug|Beta-Alanine|Participants will receive 1150mg of beta-alanine three times a day
15749716|NCT04862533|Drug|Placebo|Participants will receive matching placebo three times a day
15749717|NCT04862507|Other|Telephone call on day 90|telephone call on day 90 to assess the primary outcome (mRs 90)
15749718|NCT04862507|Diagnostic Test|Quantification of lesion water uptake by CT densitometry|Retrospective quantification of lesion water uptake by CT densitometry in admission and follow-up imaging
15749719|NCT04862494|Other|clinical surveillance|regular clinical follow up including chest X-rays, pulmonary investigations, etc...
15749720|NCT04862494|Procedure|diaphragmatic plication|plication of a hemidiaphragm, performed via laparoscopy, thoracoscopy (including robot-assisted surgery), or classical thoracotomy
15749721|NCT04862468|Combination Product|Perivascular dexamethasone|Dexamethasone delivery around target vein segment(s)
15749722|NCT04862468|Combination Product|Perivascular sham|Saline delivery around target vein segment(s)
15749723|NCT04862455|Other|Hafnium Oxide-containing Nanoparticles NBTXR3|Given intratumorally/intranodally
15749724|NCT04862455|Radiation|Hypofractionated Radiation Therapy|Undergo hypofractionated RT
15749725|NCT04862455|Biological|Pembrolizumab|Given IV
15749726|NCT04862455|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15749727|NCT04862442|Other|Qigong exercises|Specific Qigong exercises 1- Painting the rainbow 2-Raising the arms 3-Looking at the moon 4- Pushing the waves
15749730|NCT04862416|Biological|R0.6C transmission blocking vaccine|Vaccination with R0.6C transmission blocking vaccine. Volunteers will sequentially receive four administrations of R0.6C intramuscularly in the deltoid muscle on alternating sides on days 0, 28, 56 and 168.
15749731|NCT04862403|Procedure|Umbilical cord clamping distance|Intervention group I: Umbilical cord clamped at a distance of 2cm Intervention group II: Umbilical cord clamped at a distance of 3cm Control group: Usual care (clamped without measurement).
15749732|NCT04862390|Device|Continuous glucose monitoring|Home continuous glucose monitoring to be installed for two weeks during fasting Ramadan
15749733|NCT04862377|Drug|Poractant Alfa Intratracheal Suspension [Curosurf]|"Poractant alfa (Curosurf®):
~First dose of treatment: 200mg/Kg. Further doses (up to a total maximum of 3 within first 48 hours of life): 100mg/Kg."
15749734|NCT04862377|Drug|Budesonide 0.5 MG/ML|"Poractant alfa (Curosurf®) + Budesonide nebulizer solution (Budesonida Aldo-Unión 0.5mg/mL suspensión para inhalación por nebulizador®):
~First dose: 200mg/Kg of surfactant + 0.25mg/Kg of budesonide. Further doses (up to a total maximum of 3 within first 48 hours of life): 100mg/Kg of surfactant + 0.25mg/Kg of budesonide."
15749735|NCT04862364|Other|Endo Patients with Endometriosis Health Profile -30 (EHP-30) Test|The appointment of the patients consists of patients who were surgically diagnosed with Endometriosis in our clinic.
15749736|NCT04862351|Behavioral|exercise training for TechCR|3 times of supervised exercise training at the centre-based, outpatient cardiac rehabilitation clinic
15749737|NCT04862351|Behavioral|audio/video conference|weekly audio/video conference
15749738|NCT04862351|Behavioral|educational video|weekly for 6 weeks, duration of video about 10-15 minutes
15749739|NCT04862351|Behavioral|Daily log|daily dietary and exercise log
15749740|NCT04862351|Behavioral|exercise training for centre-based|6 times of supervised exercise training
15749741|NCT04862338|Dietary Supplement|Nicotinamide mononucleotide (NMN-C)|Nicotinamide mononucleotide (NMN-C) at 400 mg/day for 28 days in total
15749742|NCT04862325|Other|Multimodal Prehabilitation|"High-intensity endurance exercise training program and physical activity promotion remotely controlled with ICT (information and communications technologies).
~Nutritional counselling to achieve protein intake of 1.5-1.8 g/kg and whey protein supplements.
~Psychological intervention including motivational interview, mindfulness meditation and cognitive behavioral therapy"
15749743|NCT04862312|Behavioral|VideoDine|Participants will VideoDine with a dining partner at least six times during an eight week period. VideoDining involves sharing a meal with someone not physically present using video chat technology. Dining partners will be recruited, trained and paired with participants. Participants will be provided Amazon Echo Show devices for video chat.
15749744|NCT04862286|Drug|Risankizumab|Subcutaneous (SC) injection.
15749745|NCT04862273|Diagnostic Test|Native T1 CMR|Observed method
15749746|NCT04862273|Diagnostic Test|Web-based ATTR probability estimator (Pfizer, New York)|Observed method
15749747|NCT04862273|Diagnostic Test|99mTc-DPD scintigraphy|Reference method
15749750|NCT04862260|Drug|Cholesterol metabolism disruption|Cholesterol metabolism disruption using a combination of atorvastatin, ezetimibe and evolocumab in metastatic pancreatic adenocarcinomas
15749751|NCT04862247|Behavioral|Imaginal Exposure Condition|Participants will be asked to think and write about an eating related fear or anxiety. Specifically, they will be asked to spend 20-30 minutes writing about a specific fear or anxiety they have, then another 20-35 minutes re-reading and imagining that what they have written is happening.
15749752|NCT04862247|Behavioral|Writing and Thinking Condition|Participants will be asked to think and write about their eating disorder using specific prompts designed to help them process their eating disorder. Specifically, they will be asked to spend 20-30 minutes writing their eating disorder, then another 20-35 minutes re-reading what they wrote.
15749753|NCT04862234|Drug|Dulaglutide|Dulaglutide will be administered within 72 hours prior to planned surgical intervention.
15749754|NCT04862234|Drug|Placebo|Saline Placebo will be administered within 72 hours prior to planned surgical intervention.
15749755|NCT04862234|Device|Continuous glucose monitor (CGM), blinded|Continuous glucose monitor (CGM) sensor will be placed preoperatively and continued during surgical hospitalization to monitor glucose levels. CGM provides an estimated capillary BG level through direct measurement of interstitial glucose levels every 5-15 minutes.
15749756|NCT04862221|Drug|High-dose methylprednisolone|Subjects in the high-dose methylprednisolone arm will receive an initial dose of methylprednisolone IV 10 mg/kg/day for 3 days and 5 mg/kg/day on Day 4. Normal saline will be used as placebo pre-medications and infusions given at the same volume and duration as the eATG infusions.
15749757|NCT04862221|Drug|Equine anti-thymocyte globulin|Subjects will receive eATG IV 40 mg/kg/day on Days 1- 4. Day 1 eATG infusion is run over 8 hours and Day 2-4 infusions are run over 4 hours.
15749758|NCT04862221|Drug|Prednisolone|"Subjects will receive prednisolone 1 mg/kg on Days 5-13 followed by a gradual taper with discontinuation at 42 Days as indicated below.
~Days 5 - 13 Prednisolone PO 1 mg/kg/day (max 50 mg/day)
~Days 14- 20 Prednisolone PO 0.5 mg/kg/day (max 25 mg/day)
~Days 21 - 27 Prednisolone PO 0.3 mg/kg/day (max 15 mg/day)
~Days 28 - 34 Prednisolone PO 0.1 mg/kg/day (max 5 mg/day)
~Days 35 - 41 Prednisolone PO 0.1 mg/kg every OTHER day (max 5 mg every other day)
~Day 42 Discontinue"
15749759|NCT04862221|Drug|Placebo for prednisolone|"Subjects will receive 1 mg/kg/day of oral placebo for prednisolone on days 5-13 followed by a gradual taper to discontinuation at 42 days as indicated below. Subjects receiving oral placebo will be given a solution that closely resembles the treatment drug.
~Days 5 - 13 Placebo for Prednisolone PO 1 mg/kg/day (max 50 mg/day)
~Days 14- 20 Placebo for Prednisolone PO 0.5 mg/kg/day (max 25 mg/day)
~Days 21 - 27 Placebo for Prednisolone PO 0.3 mg/kg/day (max 15 mg/day)
~Days 28 - 34 Placebo for Prednisolone PO 0.1 mg/kg/day (max 5 mg/day)
~Days 35 - 41 Placebo for Prednisolone PO 0.1 mg/kg every OTHER day (max 5 mg every other day)
~Day 42 Discontinue"
15749760|NCT04862221|Drug|Placebo for infusions|Subjects randomized to the supportive care alone arm will receive normal saline in place of all study treatments (skin test, premedication and IV infusions) on Days 1-4 given at the same volume and duration as the eATG infusions.
15749761|NCT04862221|Drug|Diphenhydramine|Subjects in the eATG arm will receive pre-treatment medication diphenhydramine IV 1 mg/kg prior to start of eATG infusion.
15749762|NCT04862221|Drug|Methylprednisolone|Subjects in the eATG arm will receive pre-treatment medication methylprednisolone IV 1 mg/kg prior to start of eATG infusion.
15749763|NCT04862208|Dietary Supplement|Maltodextrin supplement|maltodextrin (25g in 12 oz water) 1 hour pre-exercise
15749764|NCT04862208|Dietary Supplement|Whey supplement|whey (25g in 12 oz water) 1 hour pre-exercise
15749765|NCT04862208|Dietary Supplement|Water|non-caloric control (12 oz flavored water) 1 hour pre-exercise
15749766|NCT04862208|Dietary Supplement|Maltodextrin supplement|maltodextrin (25g in 12 oz water) with no exercise
15749769|NCT04862182|Diagnostic Test|Trans-perineal ultrasound|Intrapartum trans-perineal ultrasound in predicting the mode of delivery.
15749770|NCT04862169|Other|educational intervention (SPARK)|"There are 3 modules with 11 chapters. These topics were considered as the most relevant topics for implementation of palliative care for PHC nurses. Also, topics were selected based on our previous literature review of the previous study on the content of PHC nurses training program.
~The first module is the introduction. This consists of three chapters: introduction, support system and effective communication. Total reading time is estimated to be one hour. The second module is about the nursing approach in palliative care. It is estimated to be completed in around 2 hours and 15 minutes. The last module is about end of life care.
~The participants are expected to access this module before the scheduled synchronous mode. Modules will be provided in the electronic version, so that participants are able to download and read them on their own devices. We are also providing video as trigger for case study discussion"
15749771|NCT04862169|Other|electronic version of the modules|electronic version of the modules
15749774|NCT04862117|Device|SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System|Active Implantable Vagus Nerve Stimulation device.
15749775|NCT04862104|Behavioral|Intervention group|In addition to the routine care they received, the patients in the intervention groups were given discharge training developed in the pre-discharge period. Discharge training consisted of a verbal and written information booklet containing instructions for the patient and the patient's caregiver on pain management, nutrition management, incision site care, strengthening self-care, returning to daily life activities, and colostomy care. Discharge training was given in the service after evaluating the surgical recovery status of the patient before discharge. The average duration of each training was 30-45 minutes. The patients were evaluated in terms of surgical recovery by calling by phone 2 weeks after discharge, 4 weeks and 8 weeks later. The developed education booklet was given to the patient and it was ensured that he could benefit from the information at home.
15749776|NCT04862091|Drug|Abiraterone Acetate Tablets (I)|Abiraterone Acetate Tablets (I)
15749777|NCT04862091|Drug|ZYTIGA®|ZYTIGA®
15750019|NCT04859777|Drug|MPT-0118 + pembrolizumab|MPT-0118 is an inhibitor of MALT1 protease; pembrolizumab is a PD-1 inhibitor
15749778|NCT04862078|Diagnostic Test|Shared decision making|"Shared decision making and decide surveillance strategy between standard follow-up according to the institutional practice and decide what to do advanced imagings for surveillance and guideline-based surveillance"
15749779|NCT04862078|Diagnostic Test|Usual care|standard follow-up according to the institutional practice
15749780|NCT04862052|Procedure|Intravascular management of prior implanted coronary drug eluting stent restenosis|Intravascular devices will be assessed for the management of prior implanted drug eluting stent restenosis management.
15749781|NCT04862039|Device|Virtual Reality (VR) devices|Virtual Reality (VR) devices. Subjects receiving the experimental treatment will be given a VR headset, headphones and wristband and the Philips wireless fetal-maternal monitoring system, after the necessary preparation of the abdominal skin.
15749782|NCT04861987|Drug|PCS6422 and capecitabine|PCS6422 is an experimental drug that, when combined with capecitabine, may make the immune response more active against cancer. Capecitabine is a commonly used oral fluoropyrimidine.
15749783|NCT04861961|Procedure|DS vs. SADI-S vs. OAGBP|Randomizacion of candidates for either conventional DS, SADI-S or OAGBP.
15749784|NCT04861948|Drug|IBI188|intravenous
15749785|NCT04861948|Drug|GM-CSF|subcutaneous injection
15749786|NCT04861948|Drug|Cisplatin/Carboplatin|intravenous
15749787|NCT04861948|Drug|Bevacizumab|intravenous
15749788|NCT04861948|Drug|Sintilimab|intravenous
15749789|NCT04861948|Drug|Pemetrexed|intravenous
15749790|NCT04861935|Device|ultrasound evaluation|ultrasound evaluation of normal patients and patients who have a sacral dimple
15749791|NCT04861922|Drug|Unfractionated Heparin|10 unit/kgBW/hour continuous infusion for 5 days
15749792|NCT04861909|Device|AT LISA tri 839MP|Non interventional study
15749793|NCT04861896|Behavioral|"My Guide (psychoeducation & self-management program)"|12-week long health promotion Smartphone application to support patient's side effects self-management and adherence to endocrine therapy.
15749795|NCT04861857|Dietary Supplement|Parmigiano Reggiano|subjects will receive 50 g/die of the dietary supplement
15749796|NCT04861857|Dietary Supplement|Whey Protein|subjects will receive 20 g/die of the dietary supplement
15749797|NCT04861844|Behavioral|mindfulness training|phone based mindfulness training on 4 consecutive days
15749798|NCT04861844|Behavioral|active listening|The active listening intervention script asks the participant to attend by relaxing their body and visualizing themself in various exotic locations and narratives described in the script; it also asks the participant to rate their attention level of various points. The active listening scripts were compiled from National Geographic article excerpts (taken from the public domain)
15749799|NCT04861831|Other|Power Centering for Seniors intervention|Power Centering for Seniors is an innovative East-meets-West intervention (75-minute, twice weekly, supervised group classes over 12 weeks) that integrates Western best practice muscle strength and balance training components with Chinese Tai Chi/Qi Gong to improve mobility and quality of life in older, community-dwelling adults. Home practice is recommended (approximately 30 minutes three times per week on non-course days). The modularly designed course consists of four cycles with six themes repeated in each cycle. Course exercises increase in intensity throughout the twelve-week intervention period. Repetition of cycles and themes prepares participants for continuing their individualized version of the program after the group course intervention is complete. This should lead to long-term practice of the exercises learned in the intervention and to sustained positive effects of the training.
15749800|NCT04861818|Behavioral|Moderate-intensity aerobic exercise|Eligible participants will come into the lab on day 1 and 3 at the same time of day (either morning at 7-10am or afternoon at 3-5pm). They will be then randomly assigned for a rest or an exercise session prior to the memory test. For the rest condition, they will be required to sit and relax while watching Planet Earth for 30 minutes on a cycle ergometer. During the exercise session, they will complete a moderate-intensity cardiovascular exercise for 20 minutes following a 5-min warm-up and followed by a 5-min cool-down on a cycle ergometer. They will start the memory test immediately after the rest/exercise session.
15749801|NCT04861805|Device|Vienna Aortic Valve SE System|The Vienna Aortic Valve SE System (valve sizes: 23, 26, 29 and 31 mm) is a biological valve system intended to be implanted percutaneously in the aortic valve via the transfemoral route. The device is made of bovine pericardium leaflets and a pericardium fabric skirt sutured on a radiopaque nitinol self-expanding stent system, designed for supra-annular positioning to optimize hemodynamic performance. The Vienna Aortic Valve SE System is repositionable and retrievable allowing a more optimal prosthesis positioning to minimize residual paravalvular regurgitation, atrioventricular conduction block/disturbances, and mitral or coronary compromise. The valve comes already pre-mounted on the delivery system, ready to be used, eliminating the need for assembly and crimping of the device prior to valve implantation.
15749802|NCT04861792|Behavioral|Michigan SPARC Quality Improvement Intervention|Practice facilitation, electronic health record (EHR) support, and performance monitoring and feedback combined with alcohol-related continuing medical education (CME) and maintenance of certification (MOC).
15749803|NCT04861792|Behavioral|Decision Aid for AUD|Decision aid for shared decision making about alcohol use disorder (AUD) is provided to primary care practices as part of CME. The decision aid for AUD will be available to give to patients with high risk drinking or AUD.
15749804|NCT04861779|Drug|HSK29116|Oral HSK29116
15749805|NCT04861766|Device|STYLAGE® L|Injection in both NLFs
15749806|NCT04861766|Device|Active Comparator|Injection in both NLFs
15791505|NCT04520776|Device|BAGUERA®C Cervical Disc Prosthesis|surgery
15749807|NCT04861753|Other|Reiki and back massage|In the current study, at the beginning of the treatment, the researcher held his hands 2-3 cm above the patient sand adjusted the aura of the patient by making circular movements from the head to the feet. After this process of aura attunement, the researcher placed his hands directly on the patient's body. In the areas where the practitioner had placed his hands for an average of three minutes, starting from between the eyes, the researcher felt various degrees of warmth and tingling in his palms. Only the back was left exposed to prevent the patient becoming cold. The researcher took a little non-aromatic baby oil in hand and heated it, then began a 20-minute-long massage. The massage consisted of 6.5 minutes of effleurage (stroking), 3.5 minutes of petrissage (kneading), 13 minutes of effleurage and seven minutes of petrissage.
15749808|NCT04861740|Other|Autism ALERT|Autism Access Link for Early Referral and Treatment [ALERT], the intervention proposed in this application, is a novel state-wide referral and case management platform that PCPs can activate to ensure that a child with suspected ASD receives all necessary ASD diagnosis and treatment resources in a single referral, radically simplifying a complex diagnostic and treatment process.
15749809|NCT04861740|Other|Screening Intervention|Autism screening intervention only.
15749810|NCT04861727|Other|MRPA procedure|The patient will receive the device for BP measurement at home for a week and two daily measurements will be taken, one in the morning (between 6 and 10 am) and one in the afternoon / evening (between 6 pm and 10 pm), for seven days. At the end of the procedure, it is expected to record 14 measurements (representing a total of 42 in seven days), but it is considered feasible when at least 10 results are recorded, respecting the number of two measurements per day, in the periods oriented. Participants who do not reach the satisfactory number of measures or do not check between the times mentioned above, will be invited to repeat the procedure
15749811|NCT04861727|Other|Pharmaceutical intervention|The suggestion procedure, for this research, is defined as the pharmaceutical act of forwarding a letter of suggestion to the prescriber, previously agreed with the patient, based on clinical evaluation, review of pharmacotherapy, adherence to treatment and result of the MRPA procedure.
15749812|NCT04861714|Device|Regeneten|Augmentation of standard subscapularis repair with regeneten patch
15749813|NCT04861714|Procedure|Standard repair|Standard subscapularis repair
15749814|NCT04861701|Behavioral|Static stretching exercise|The intervention of this study is home-based stretching exercise. The experimental group will receive 6 stretching exercises which stretch 60 seconds for each side (left or right) of each movement, and relax for 10-20 seconds between the movements. It will take 10-15 minutes every day for continuous 4 weeks. The 6 stretching exercises include : (1) pectoral muscles + calf muscles ; (2) quadriceps ; (3) levator scapulae ; (4) gluteal muscles ; (5) hamstrings ; (6) trunk side-flexors.
15749815|NCT04861688|Combination Product|Traditional Chinese Medicine (NeuroAiD II™ (MLC901)|NeuroAiD II™ (MLC901) contains the extracts of 9 botanical active ingredients blended with commonly used excipients. The 9 botanical active ingredients are traditional herbs well documented in the Pharmacopoeia of the People's Republic of China.
15749816|NCT04861688|Other|Placebo|Placebo with same appearance as active intervention
15749817|NCT04861675|Procedure|Full mouth rehabilitation under general anaesethia|Assessment of change in oral health related quality of life , body growth status and oral hygiene status for children with special health care needs after full mouth rehabilitation under general anesethia,
15749818|NCT04861662|Procedure|Free gingival graft procedure|Free gingival graft procedure applied to implants with KM<2 mm to increase the width of keratinized mucosa surrounding them
15749819|NCT04861649|Biological|fecal microbiota transplantation|"The nasointestinal tube was placed and the fecal bacteria of healthy people were transplanted with liquid fecal bacteria (three transplants per course of treatment).
~200ml of bacterial liquid was transplanted for each course, containing 40g of bacterial volume, transplanted consecutively for 3 times, once a day)"
15749820|NCT04861636|Behavioral|HealthTRAC|Behavioral weight management intervention targeting emotion regulation skill building. Intervention components will be delivered in 27.5 hours of direct contact time across 12 months. All adolescents will be assessed prior to randomization (baseline), immediately following the intervention (4 months), upon completion of maintenance sessions (12 months) and 18 months after the start of intervention.
15749821|NCT04861636|Behavioral|SBWC|Behavioral intervention focused on behavioral weight control. Intervention components will be delivered in 27.5 hours of direct contact time across 12 months. All adolescents will be assessed prior to randomization (baseline), immediately following the intervention (4 months), upon completion of maintenance sessions (12 months) and 18 months after the start of intervention.
15749822|NCT04861623|Other|Orange juice|Orange juice will be purchased commercially.
15749823|NCT04861623|Other|Placebo juice (Fanta)|Fanta will be purchased commercially.
15749824|NCT04861610|Behavioral|Brief mindfulness based program|An intervention promotes the acceptance and emotion regulation in caregiving for frail older adults
15749825|NCT04861610|Behavioral|Psychoeducation|An intervention promotes the coping and problem solving in caregiving for the frail older adults
15749828|NCT04861584|Drug|Neoadjuvant Toripalimab in Combination With Gemcitabine and Cisplatin|4 cycle neoadjuvant therapy and radical cystectomy
15749829|NCT04861571|Other|Dietary intervention with very low calorie diet|Very low-calorie diet treatment: The VLCD program will last 8 weeks and then will be followed by a gradual re-introduction of food through the next 2 months. The only sources of nutrition during this phase are the Optifast® products providing up to 800 kcal per day. Two liters (67.63 fl oz) of water should also be consumed each day. Participants will receive Optifast® replacement meals at no cost. The replacement meals will be dispensed at the UIHC Clinical Research Unit on weeks #1, #2, and #4. Participants will be instructed to use 5 replacement meals per day (800 kcal total) with 40% of calories as protein, 40% as carbohydrate, and 20% as fat
15750020|NCT04859764|Device|Reparel knee sleeve|Unlabelled thermo-active knee sleeve that improves bloodflow to knee and decreased pain
15749833|NCT04861545|Other|Soy|"Isolated soy protein food sources are foods that include isolated soy protein in different forms and matrix (e.g. soy beverage and meat analogue).
~Non-isolated soy protein food sources of soy protein are foods made with soy (e.g. Tofu, tempeh, edamame)."
15749834|NCT04861532|Diagnostic Test|Imaging|MRI scanning using new protocols
15749835|NCT04861519|Other|Collecting invasive FFR measurements.|Invasive FFR measurements from the patient's hospital records will be collected.
15749836|NCT04861506|Procedure|endovascular treatment|All the patients are treated by endovascular therapy, through contralateral femoral artery approach, ipsilateral antegrade femoral artery approach or brachial artery approach. If the lesion is difficult to pass in antegrade approach, retrograde puncture at the distal artery of the lesion can be performed. Surgeons can choose treatment methods such as pharmacomechanical thrombectomy (PMT) and catheter-directed thrombolysis (CDT) for thrombus removal according to the characteristics of the lesions and hospital conditions.
15749837|NCT04861480|Biological|C-4-29 Cells|Drug: C-4-29 Cells； Administration method: intravenous infusion； Subjects will be treated with Fludarabine and Cyclophosphamide before cell infusion.
15749838|NCT04861467|Drug|Camrelizumab|IV
15749839|NCT04861441|Device|Aircast Cryo Cuff (Shoulder) and Aircast Cryo Cuff I/C Motorized Cooler|Patient will wear the continuous cryo cuff for a designated period of time and will record their pain and narcotic use post operatively.
15749840|NCT04861441|Device|Icepacks|Standard of care icepacks will be used postoperatively for designated amount of times and patients will record pain and narcotic use post operatively.
15749841|NCT04861428|Other|IQOS|IQOS is a heat-not-burn tobacco product (consisting of an electronic heating device and Heatstick tobacco rods).
15749842|NCT04861428|Other|Smoking as Usual|Cigarette smoking
15749843|NCT04861415|Radiation|Sterotactic Body Radiotherapy|Hypofractionated stereotactic radiation treatment.
15749844|NCT04861415|Radiation|Conventionally Fractionated Radiation|External beam radiation therapy treatment
15749845|NCT04861402|Device|The ICP monitoring will be performed in a non-invasive method developed by Brain4Care|"The ICP monitoring will be performed in a non-invasive way through the cranial deformation method developed by Brain4Care Inc.
~The selected patients will be monitored until 1h/day for 7 sequential days or even discharge. The clinical outcomes such as ventilatory status will be noted (if the subject is under oxygen supplementation, using non-invasive mechanical ventilation or intubated), the ventilatory parameters during the monitorization will be analyzed in the intubated group (or those from a non-intubated group who was intubated during the seven days of hospitalization) including IFO2, CV, PEEP, driving pressure, and pressure plate as well as ventilatory asynchronies. Some changes in ventilatory parameters during monitorization will be noted. These procedures will be applied to all groups, excepted to the healthy group. This last group will be monitored only once for 30 minutes at the Federal University of São Carlos (UFSCar)."
15749846|NCT04861389|Procedure|Arterial access|Arterial access for primary percutaneous coronary intervention in STEMI patients
15749847|NCT04861376|Drug|Pueraria lobata|The dose of Pueraria lobata granules is one sachet per day, 1.5g per sachet, which equivalent to 15g of the original drug.
15749848|NCT04861376|Drug|Pueraria thomsoni|The dose of Pueraria thomsoni granules is one sachet per day, 1.5g per sachet, which equivalent to 15g of the original drug.
15749849|NCT04861376|Other|Placebo|The placebo group will take the same dose as the other two groups.
15749850|NCT04861350|Other|imagery training|Hip adduction with elastic band, sliding, and Copenhagen adduction exercise will be instructed to the subjects with video, and they will practice each exercise for 3 times in physical to familiarize with the program. Then, the subjects will mentally simulate each exercise with video 10 times for a set, 3 sets totally. It will take approximately 5~8 minutes to finish each movement.
15749851|NCT04861350|Other|physical training|Hip adduction with elastic band, sliding, and Copenhagen adduction exercise will be instructed to the subjects with video, and they will practice each exercise for 3 times in physical to familiarize with the program. Then, the subjects will physically perform each exercise with supervision of investigator 10 times for a set, 3 sets totally. It will take approximately 5~8 minutes to finish each movement.
15749852|NCT04861350|Other|imagery combined with physical training|Hip adduction with elastic band, sliding, and Copenhagen adduction exercise will be instructed to the subjects with video, and they will practice each exercise for 3 times in physical to familiarize with the program. Then, each exercises will be mentally simulated with video for a set and physically performed with supervision of investigator for 2 sets, 10 times for each set and 3 sets totally. It will take approximately 5~8 minutes to finish each movement.
15749853|NCT04861337|Drug|Remimazolam|Remimazolam is infused at a rate of 0.25 mg/kg/h from end of anesthesia induction until 15 minutes before the end of surgery.
15749854|NCT04861337|Drug|Placebo|Normal saline is infused at a rate same as in the remimazolam group from end of anesthesia induction until 15 minutes before the end of surgery.
15749855|NCT04861324|Behavioral|Dietary Intervention|Increasing fruit and vegetable by two servings a day and at least 30 min a day of postprandial physical activity
15749856|NCT04861311|Behavioral|Mindfulness/Acceptance-Based Smartphone App (MABSA) Intervention|The intervention is based on the principles of Acceptance and Commitment Therapy (ACT). Therefore, the intervention is an ACT-based smartphone app delivered for 6 weeks in which participants will be applying the mindfulness and acceptance exercises embedded in the app. The mindfulness and acceptance exercises are audio-guided mindfulness meditations and video lessons about ACT.
15749857|NCT04861298|Drug|standard of care for COVID-19 as per the hospital guidelines|Hospital standard of care treatment for COVID-19
15749858|NCT04861298|Dietary Supplement|Quercetin Phytosome (QP)|Daily dose of 600 mg of Quercetin for 1st week and then 400 mg for the 2nd week
15749859|NCT04861285|Device|RACESTYPTINE Solution with cord|The dentist inserts a non-medicated gingival retraction cord into the sulcus and then impregnates the cord in situ with a few drops of RACESTYPTINE Solution. The impregnated cord is left in place a few minutes and then removed. The gingival sulcus is washed and gently air-dried before taking impression.
15749860|NCT04861285|Device|RACEGEL with cord|The dentist applies a sufficient amount of RACEGEL directly into the sulcus, following the contour of the prepared tooth, and then inserts a non-medicated gingival retraction cord into the sulcus. The impregnated cord is left in place a few minutes and then removed. The sulcus is washed and gently air-dried before taking impression.
15791506|NCT04520776|Device|Mobi-C® Cervical Disc|surgery
15749861|NCT04861285|Device|RACEGEL without cord|The dentist applies a sufficient amount of RACEGEL directly into the sulcus, following the contour of the prepared tooth. The gel is left in place a few minutes and then removed. The sulcus is washed and gently air-dried before taking impression.
15749862|NCT04861272|Behavioral|Survey|Online survey
15749863|NCT04861259|Drug|Crovalimab|Crovalimab will be administered at a dose of 1000 mg IV (for participants with body weight between 40 and 100kg) or 1500 mg IV (for participants with body weight >=100kg) on Week 1 Day 1. On Week 1 Day 2 and on Weeks 2, 3 and 4, it will be administered at a dose of 340 mg SC. On Week 5 and Q4W thereafter, it will be administered at a dose of 680 mg SC (for participants with body weight between 40 and 100kg) or 1020 mg SC (for participants with body weight >=100kg).
15749864|NCT04861246|Device|Laser|The device will be used to do Laser treatment. To compare the therapeutic effect to laser treatment before and post treatment for 14 and 60 days.
15749865|NCT04861246|Device|ApolloVue® S100 Image System|The device is an in vivo non-invasive optical coherence tomography and will be used to obtain OCT images before and after laser treatment of skin.
15749866|NCT04861246|Device|VISIA®|The device is skin analysis system and will be used to obtain before and after images of laser treatment.
15749867|NCT04861233|Other|No Intervention|This is a non-interventional study.
15749868|NCT04861220|Behavioral|Physical exercise|"The prescription will be divided into 3 phases:
~Warm-up: with the object of removing the body from rest and preparing it to start the activity, it consists of exercises for upper and lower limbs, 1 minute each.
~Physical exercise: Object of physical conditioning, it consists or aerobic training, with the option of cycling, walking or elliptical, and muscle activation through concentric contraction of the rectus abdominis in supine position, sit-up, abduction of shoulder to full widht. In the 1st week, repeat each exercise 10-15 times. In the 2nd week, 10-13 times, 2 times, with a 1-minute interval between eacg session. In the 3rd week, 3 times, with 2 intervals of 1 minute between each session.
~Relaxation: Streching the arms above the head, stretching the legs and stretching the trunk to the left and right side will be oriented. Stretches will be counted in deep breaths, for a total of 5 minutes for each moviment."
15749869|NCT04861207|Drug|Cladribine|The conditioning regimen used will be cladribine-based at a dose of 5 mg / m2 for 5 days (iv.) and total body irradiation at a total dose of 12 Gy in three fractions.
15749870|NCT04861194|Radiation|Neurovascular-sparing|Dose reduction of the neurovascular bundles, internal pudendal arteries, corpora cavernosa, and penile bulb during 5x7.25 Gy MRgRT
15749871|NCT04861181|Biological|Pharmacokinetics, Dosage of Niraparib|The biological samples collected during the NIRAPK study will be blood only. The complete biological work-up will be processed in the same way as the usual routine care procedure. Serum niraparib will be measured over 3 courses just prior to treatment (Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 3 Day 1). Close-up kinetic measurements will also be taken at 1 Hour, 2 Hours, 4 Hours, 6 Hours and 24 Hours at Cycle 1 Day 15.
15749872|NCT04861168|Procedure|driving pressure guided ventilation|driving pressure guided ventilation
15749873|NCT04861168|Procedure|Conventional protective lung strategy|Conventional protective lung strategy
15749874|NCT04861155|Device|SIVA-P3|Digital cough recording: Participants receive a small, wearable data recorder, wear it during waking hours and keep it on the nightstand during sleep for 7x24 hours. The data is sent to a smartphone application, where a cough detection algorithm converts it into time-stamped cough events. Participants respond to questions on their smartphone once a day for additional context data. The cough events and context data are sent to a secure online database for further evaluation. For the first 24 hours, segments of audio data are sent to be able to validate the performance of the cough detection algorithm. Afterwards, only cough events and context data are sent from the participant's smartphone.
15749875|NCT04861142|Drug|Anti-osteoporotic medication( alendronate or denosumab)|Initiation of anti-osteoporotic medication (alendronate or denosumab)
15749876|NCT04861129|Procedure|Bowen therapy|Intervention is provided weekly for 6 sessions lasting 30-40 mins per treatment session
15749877|NCT04861129|Procedure|Sham Bowen therapy|Sham Intervention is provided weekly for 6 sessions lasting 30-40 mins per treatment session
15749878|NCT04861116|Behavioral|Intervention program for test anxiety|12-week ICT-based manualized, targeted and facilitated individual intervention for adolescent students, that aims to promote compassion, acceptance and mindfulness, in order to help improve test anxiety's regulation (and consequently symptom reduction), as well as increase general and school-related well-being, while promoting valued life action.
15749879|NCT04861103|Drug|Lovenox|Three times a day dosing and measuring Xa peak and trough levels
15749881|NCT04861064|Drug|Sirolimus|Participants will get Sirolimus (1.5-2 2mg/m2) weekly for 6 months.
15749882|NCT04861051|Drug|Ketamine|Study participants will receive 0.5mg/kg of ketamine - one single infusion
15749883|NCT04861038|Device|aerSleep II|Continuous negative external pressure (cNEP) system that maintains an open airway by applying negative pressure to the anterior neck via a soft silicone collar
15749884|NCT04861012|Device|Ultrasound|All subjects initially will be subjected to abdominal ultrasound, and if fatty liver is detected fibroscan will be done
15749885|NCT04860999|Procedure|Osteopathic Manipulative Treatment|The osteopathic manipulations focused on treating the asymmetric postural dysfunction that was identified by the initial functional structural evaluation. The manipulation consisted of typical time-honored osteopathic treatments directed at the identified somatic dysfunction(s). These techniques were clinically directed and include: soft tissue, muscle energy, high velocity low amplitude, low velocity high amplitude as well as facilitated positional release as indicated.
15749886|NCT04860986|Device|EarliPoint|EarliPoint is a non-invasive diagnostic device for ASD
15749887|NCT04860973|Device|Weighted blankets|Weighted blankets given to patient for 7 days/nights
15749888|NCT04860960|Drug|Hydroxypropyl-beta-cyclodextrin|Dose is 2000 mg/kg body weight provided every 2 weeks intravenously
15749889|NCT04860960|Drug|Placebo|0.5N saline provided every 2 weeks intravenously
15749890|NCT04860947|Diagnostic Test|Brain MRI|"Axial DWI with ADC card
~Axial 2D TSE T2/DP or 3DT2
~Gadolinium injection (0.1 mmol/kg)
~3D Fluid-attenuated inversion recovery
~3D T1 with Gadolinium injection."
15749891|NCT04860947|Diagnostic Test|Spinal Cord MRI|Sagittal T2 Sagittal T1 with Gadolinium injection
15749892|NCT04860947|Diagnostic Test|Retinal imaging|spectral-domain high definition optical coherence tomography
15749893|NCT04860934|Behavioral|Dual Task Training Program Group|Fifteen patients will receive Dual Task Training Program. Total Period: 8 Weeks.
15749894|NCT04860934|Behavioral|Control Group|Each child in this group will receive the selected physical therapy program which include mobility exercises, strengthening exercises, balance exercises, gait training exercises, and exercises to improve physical conditioning for one-hour session three times weekly for 8 successive weeks.
15749895|NCT04860908|Other|no intervention, observation only|no intervention, observation only
15749896|NCT04860895|Diagnostic Test|AP-23|AP-23 newly developed point of care system as a well-automated combination of multi-spectral technology and a distributed cloud computing A.I. system which has been developed to detect COVID-19.
15749897|NCT04860856|Drug|0.5% ropivacaine|The maximal single dose of ropivacaine without vasoconstrictor is 2-3 mg/kg.9 0.5% ropivacaine has 5 mg/mL of ropivacaine. 20 mL of 0.5% ropivacaine has 100 mg of ropivacaine. 100 mg of ropivacaine can be toxic to a patient less than 33-50 kg or 73-110 lb. If a patient weighs less than 110 lb, the ropivacaine dose will be scaled down below 2 mg/kg.
15749898|NCT04860856|Drug|Normal Saline|20ml of normal saline
15749899|NCT04860843|Drug|Thoracic paravertebral block|Participants will receive a thoracic paravertebral with local anesthetic infiltrate (30ml of 0.35% ropivacaine with 1:400K epinephrine).
15749900|NCT04860843|Drug|Pecs II block|Participants will receive a and a pecs II block with local anesthetic infiltrate (30ml of 0.25% ropivacaine with 1:400K epinephrine).
15749901|NCT04860843|Drug|Sham Pecs II block|Participants will receive a and a pecs II block with saline infiltrate (30ml normal saline; 0.9% NaCl).
15749904|NCT04860817|Biological|Target CD7 CAR-T cells|"Enrolled participants are allocated to one of three different dose levels of target CD7 CAR-T cells. The infusion dose of CAR-T cells will start at low dose and then rise to higher dose after completion of low dose group.
~Dose level one: 0.6×10^7 cells/kg;
~Dose level two: 1×10^7 cells/kg;
~Dose level three: 1.5×10^7 cells/kg. Before CAR-T infusion, all participants will receive a preconditioning therapy suggested as: Fludarabine 30 mg/m^2×6d, Cyclophosphamide 300 mg/m^2×6d or Cyclophosphamide 600 mg/m^2×6d. After completion of preconditioning therapy, infusion of CAR-T cells needs to start within 1 week. Participants will receive one infusion of CAR-T cells which will take between 15 and 30 mins."
15749905|NCT04860804|Drug|Aspirin and Ketamine|Drug: Proprietary oral formulation of 0.5mg/kg of ketamine + 324mg of aspirin
15749906|NCT04860804|Drug|Oral Ketamine|Proprietary oral formulation of 0.5mg/kg of ketamine
15749907|NCT04860791|Other|questionnaires|Patients will complete the MSWDQ-23 in French, as well as the DEX, questionnaire for the evaluation of executive dysfunction in daily life, to evaluate their cognitive complaints and the SF36 questionnaire to evaluate their quality of life
15749908|NCT04860778|Dietary Supplement|BDNF Essentials|Participants will take two capsules, twice daily with water for 84 days.
15749909|NCT04860765|Device|SAPIEN 3 THV|SAPIEN 3 THV in the pulmonic position
15749910|NCT04860752|Device|Transcatheter Aortic Valve Implantation (TAVI)|Subjects will undergo TAVI
15749911|NCT04860739|Drug|COMIRNATY|One dose of COMIRNATY
15749912|NCT04860726|Other|Joint mobilization|Maitland Mobilization GIII and GIV i. PA Central and unilateral vertebral pressure ii.Transverse vertebral pressure iii. heating pad for 15 minutes
15749913|NCT04860726|Other|Myofascial Release|"Myofascial release is a hands-on soft tissue technique that facilitates a stretch into the restricted fascia. A sustained pressure is applied into the restricted tissue barrier; after 90-120 seconds the tissue will undergo histological length changes allowing the first release to be felt. The therapist will follow the release into a new tissue barrier and holds. After a few releases the tissue will become softer and more pliable.
~The middle point of the Lateral raphae of the Thoracolumbarfascia between the posterior musculofascial junction of the Transversus Abdominis will be identified by ultrasonography. Vertical manual pressure will be applied on the middle point of the thoracolumbarfascia for 1 min ii. heating pad for 15 minutes"
15749914|NCT04860726|Other|Joint mobilization & Myofascial Release|"Maitland Mobilization GIII and GIV i. PA Central and unilateral vertebral pressure ii.Transverse vertebral pressure iii. heating pad for 15 minutes iv. Myofascial release is a hands-on soft tissue technique that facilitates a stretch into the restricted fascia. A sustained pressure is applied into the restricted tissue barrier; after 90-120 seconds the tissue will undergo histological length changes allowing the first release to be felt. The therapist will follow the release into a new tissue barrier and holds. After a few releases the tissue will become softer and more pliable.
~The middle point of the Lateral raphae of the Thoracolumbarfascia between the posterior musculofascial junction of the Transversus Abdominis will be identified by ultrasonography. Vertical manual pressure will be applied on the middle point of the thoracolumbarfascia for 1 min"
15749915|NCT04860713|Drug|aspirin and ketamine|Drug: Proprietary oral formulation of 0.85mg/kg of ketamine + 324mg of aspirin
15749916|NCT04860713|Drug|Nurtec (Rimegepant)|Drug: 75 mg of ODT
15749917|NCT04860700|Drug|anlotinib hydrochloride|Patients receive anlotinib hydrochloride 12mg orally once daily on days 1-14. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
15749918|NCT04860674|Drug|PD-1 inhibitor +ICE|PD-1 inhibitor (tirelizumab) combined with ifosfamide, carboplatin and etoposide (ICE) regimen
15749919|NCT04860661|Drug|Esketamine|After delivery, the parturient was given a loading dose of esketamine, and then a small dose of esketamine was added into PCIA analgesia pump
15749920|NCT04860661|Drug|Normal saline|10 ml normal saline
15749921|NCT04860648|Other|lung ultrasound|doctors treat the patients combining the Lus results and clinical practice
15749922|NCT04860635|Drug|F14 (sustained release celecoxib)|Celecoxib in BEPO® drug delivery system
15749923|NCT04860622|Diagnostic Test|Serum thyroid function tests|At the first hospital visit, the blood tests will be made for TSH, FT4, FT3, and beta HCG concentration measurement
15750111|NCT04859062|Other|lidocaine gel 2%|assessing its efficacy in decreasing muscle traction pain
15749924|NCT04860609|Other|Conventional Physiotherapy|"The treatment will be given in the following way.
~Tens
~Infrared/Moist Heat heat for 10 minutes at low back region.
~Lumbar Mobilization (Maitland) CPA 3 sets of 10 reps
~Stretching Exercises (Calf, Hams, Back Extensors) 3 sets of 8-10 reps
~Strengthening Exercises (Back Extensors) 3 sets of 8-10 reps
~Postural Education
~Home Plan
~Bed Rest with lumbar Sacral Support
~Home plan:
~Exercises Posture Correction Precautions Contra indication"
15749925|NCT04860609|Other|Lumber Spinal Decompression|"The treatment will be given in the following way.
~Tens
~Infrared/Moist Heat heat for 10 minutes at low back region.
~Lumbar Mobilization (Maitland) CPA 3 sets of 10 reps
~Stretching Exercises (Calf, Hams, Back Extensors) 3 sets of 8-10 reps
~Strengthening Exercises (Back Extensors) 3 sets of 8-10 reps
~Postural Education
~Home Plan
~Decompression therapy session lumbar spinal decompression therapy for 30 minutes.
~Home plan:
~Exercises Posture Correction Precautions Contra indication"
15749926|NCT04860596|Behavioral|collaborative health management model|nursing education program
15749927|NCT04860583|Other|Renal ultrasound|
15749928|NCT04860570|Device|Double-ring wound-edge protector|Double-ring wound-edge protector: Alexis Applied Medical ®, Rancho Santa Margarita, California.
15749929|NCT04860557|Other|cognitive skill, dual task and physical activity assessment|Montreal Cognitive Assessment Test, Trail Making Test (TMT) A & B sections and Stroop test for cognitive ability assessment, 10 meter walking test (single-double task) for dual task, Time up and Go test (single-double task), physical International Physical Activity Questionnaire was used for activity and The Exercise Benefit / Barriers Scale was used for exercise perception.
15749930|NCT04860544|Procedure|RED BLOOD CELLS TRANFUSION|
15749931|NCT04860531|Drug|Lumbar Facet Joints intra-articular injection with Platelet Rich Plasma|Floroscopy guided by C-arm Intraarticular injection in Lumbar facet Joints
15749932|NCT04860531|Drug|Lumbar Facet Joints intra-articular injection with a mixture of 0.5% lidocaine and 5mg/ml of betamethasone|Lumbar Facet Joints intra-articular injection
15749933|NCT04860518|Drug|IFN beta-1a|Treated daily with IFN beta-1a 10 μg as an IV bolus for 6 days while hospitalised
15749934|NCT04860518|Drug|Dexamethasone|Treated daily with dexamethasone as an IV bolus for 6 days while hospitalised
15749935|NCT04860505|Drug|Doxycycline|Doxycycline (DOX [200 mg]) is an oral medication used to treat or prevent infections that are strongly suspected to be caused by bacteria; it is an antimicrobial drug indicated for bacterial infections such as sexually transmitted infections.
15749936|NCT04860505|Drug|Biktarvy|Biktarvy (200mg) is an oral combination anti-HIV medication that contains the drugs tenofovir alafenamide, emtricitabine, and bictegravir.
15749937|NCT04860492|Dietary Supplement|Renalof 325mg|RENALOF® is a preparation that contains active Agropyron repens extract. It is designed with specific antioxidant compounds triggered by a bio-catalyst process that enables improved control of the production mechanism of anti-stress molecules. RENALOF® contains extracts of couch grass (triticin, potassium salts, agropyron, silicic salt, inositol, vanillin, saponin, mucilage, iron, and others trace elements), mannitol, corn starch and magnesium silicate. The magnesium in RENALOF® inhibits stone formation by inhibition of growth of crystals and aggregation.
15749938|NCT04860479|Device|ultrasound|ultrasonography to inguinal region
15749939|NCT04860466|Drug|CC-96673|IV Infusion
15749940|NCT04860453|Genetic|WES via Illumina NextSeq 550 sequencing system|Sequencing will be performed on an Illumina sequencing system
15749941|NCT04860453|Diagnostic Test|Blood Draw|Blood draw will be via any University Hospitals Laboratory site and sent at room temperature via courier to the Center for Human Genetics (CHG) Laboratory
15749942|NCT04860453|Diagnostic Test|Skin biopsy|Skin samples obtained via 3mm punch biopsy will be suspended in cell culture media prepared per CHG routine and sent via courier to the Center for Human Genetics Laboratory
15749943|NCT04860453|Diagnostic Test|Saliva Sample|Participant will provide a saliva sample which be shipped to University Hospitals Laborator site at room temperature
15749944|NCT04860440|Device|GeneActiv wrist worn accelerometer|Wrist worn device worn for 7 days
15749945|NCT04860427|Device|trapezoidal condylar plate|trapezoidal condylar plate open reduction and fixation
15749946|NCT04860427|Device|two miniplates|two miniplates open reduction and fixation
15749947|NCT04860414|Biological|Blood sampling|Fasting blood glucose, dosage of acylated and non-acylated ghrelin, leptin, insulin and serotonin.
15749948|NCT04860414|Other|Cognitive Assessment|QPC Cognitive complaint questionnaire, CDR functional autonomy scales and IADL 4 items, MMSE cognitive scores, Dubois 5-word test, clock test, BREF, Isaacs test, BARD naming battery and MADRS depression scale
15749949|NCT04860414|Other|Subjective taste tests|Scales of taste perceptive intensity, taste pleasure, hunger sensation (visual analogue scales from 0 to 10 cm) and food preferences on the one hand, and on the other hand, subjective tests of taste threshold determination by triangular tests of increasing sugar solution concentrations.
15749950|NCT04860414|Other|Objective taste tests|Recording of gustatory evoked potentials
15749951|NCT04860401|Device|Measurement of tissue oxygenation with novel diagnostic near-infrared spectroscopy device (OxyPrem) (no clinical decisions based on oxygenation levels)|The precision of OxyPrem is assessed by repeated measurements of tissue oxygenation and hemoglobin concentration. The accuracy of OxyPrem is assessed by comparing the measurement data to those acquired simultaneously by established NIRS devices and standard clinical monitoring devices. In substudy 1, healthy adult subjects are enrolled, in substudy 2, measurements are conducted on preterm neonates.
15749952|NCT04860388|Procedure|closed eruption technique|The impacted teeth treated with closed eruption technique firstly. Orthodontic traction started a week later the sutures were removed. When the crown of the maxillary impacted canine was fully visible in the mouth, its bracket was inserted, and aligned within the dental arch using double-arch technique. Posttreatment plaque index, gingival index, gingival bleeding index, probing depth, and keratinized and attached gingival width and gingival thickness measurements of the impacted canines and controls were performed. The measurements compared with the contralateral canines that served as control teeth.
15749953|NCT04860375|Procedure|Multidisciplinary patient care|A holistic, multidisciplinary, patient-centered care.
15749954|NCT04860375|Other|Standard care|Standard care in Sweden
15749955|NCT04860362|Behavioral|PEERS|Structured social skills curriculum including didactics, behavioral rehearsal, parent coaching, and parent coaching support.
15750578|NCT04855266|Drug|Placebo|Normal saline (NaCl 0.9%) 5 mL/kg (maximum volume 210 mL)
15749956|NCT04860349|Other|High Intensity Interval Training|4-weeks of high intensity interval training, 3 sessions/week on alternate days. each session for 20 minutes, excluding the warm-up and cool-down.
15749957|NCT04860336|Other|Observational|Observational
15749958|NCT04860323|Other|Analytical Treatment Interruption|"Participants will stop taking their HIV medication and will stay off HIV medication unless and until the HIV levels in their blood show that their immune system is not controlling their HIV or they meet other ART re-start criteria as noted in section Detailed Description."
15749959|NCT04860310|Procedure|Endometrial biopsy|Subjects need to collect 5ml whole blood (EDTA or heparin anticoagulant) once in the morning on an empty stomach. Endometrial tissue samples were taken during a complete 28-day menstrual cycle, a total of 6 times, and blood was taken to measure the level of gonadal hormones before each sampling.
15749961|NCT04860284|Drug|Hydroxychloroquine tablets|Hydroxychloroquine tablets 400mg given orally 12 hourly on day 1 and 200mg 12 hourly on day 2 to 5
15749962|NCT04860271|Procedure|Manual Acupuncture|Manual acupuncture treatment using different types of needle
15749963|NCT04860258|Biological|CVnCoV Vaccine|Intramuscular (IM) injection in the deltoid area, preferably in the non-dominant arm.
15749964|NCT04860219|Dietary Supplement|Lactoferrin|7 successive days treatment of Lactoferrin started within day 0 of COVID-19 diagnosis by RT-PCR
15749965|NCT04860180|Procedure|adrenalectomy|
15749966|NCT04860167|Drug|Propofol|Injection propofol was given to keep the BIS value 60-80 during the ERCP procedure
15749967|NCT04860167|Drug|Diclofenac Sodium and Lignocaine 10 % spray|Injection Diclofenac sodium was given in the preoperative area 30 minutes before the procedure and four squirts of 10% lignocaine were given 5 minutes prior to the start of the procedure
15749968|NCT04860154|Drug|Hematoporphyrin|Patients with negative skin test of hematoporphyrin Injection (3.0-5.0mg/Kg plus saline 250 mL intravenous drip, the drip was completed within 1 hour) and keep patients away from the light. The first PDT therapy was performed 24 hours after infusion of hematoporphyrin injection by ERCP. The biliary tumor necrosis was observed and the biliary tract was cleaned up 24 hours later and then PDT therapy showed again if necessary. Multiple plastic stents or bald metal stents will be placed. Follow up regularly after the procedure, PDT therapy would be given again in 3 months.
15749969|NCT04860141|Drug|Gabapentin 600mg|The patient will take gabapentin 600mg 2 hours prior to the procedure
15749970|NCT04860141|Drug|Placebo|the patient will take a pill that looks like gabapentin 2 hours prior to the procedure
15749971|NCT04860128|Behavioral|Sports technology application|Each of the intervention groups will use in after-school hours a different mobile app for 12 weeks, with a frequency and duration of 60 minutes of training, at least three times a week. A weekly record will be kept by the adolescents in which they will have to indicate the weekly practice frequency, the duration of the activity and the kilometers covered through a report that the adolescents will deliver to the teacher at the end of each week.
15749972|NCT04860115|Procedure|Modified pectoralis block (PEC II) and pecto-intercostal fascial plane block (PIFB)|"PECS II: Ultrasound guided block involving injection of 20 ml of 0.25% L-bupivacaine with dexmetomidine into an interfascial plane between the serratus anterior muscle and the external intercostal muscles followed by the needle withdrawal into an interfascial plane between the pectoralis major and pectoralis minor muscle where further 10ml will be administered.
~PIFB: Ultrasound guided block involving injection of 10 ml of 0.25% L-bupivacaine with dexmetomidine into an iterfascial plane between the pectoralis major and the intercostal muscles approximately 2 cm laterally from the sternum to cover T2 to T6 dermatomes."
15749973|NCT04860102|Procedure|hands on|Hands-on was defined as involving one hand on the fetal head, applying pressure to control expulsion, with the other hand applying pressure on the maternal perineum
15749974|NCT04860089|Other|Research vouchers for high THC medical cannabis product|Randomization will be 1:1 to high THC or high CBD research vouchers. Participants will not be randomized to receive a specific medical cannabis product, but rather a specific voucher. Randomization will occur in blocks and will be stratified by history of cannabis use (use in the past 6 months; yes/no), symptoms of depression (moderate or severe [>15 on PHQ-9; yes/no]), and HIV viremia (undetectable viral load (VL); yes/no).
15749975|NCT04860089|Other|Research vouchers for high CBD medical cannabis product|Randomization will be 1:1 to high THC or high CBD research vouchers. Participants will not be randomized to receive a specific medical cannabis product, but rather a specific voucher. Randomization will occur in blocks and will be stratified by history of cannabis use (use in the past 6 months; yes/no), symptoms of depression (moderate or severe [>15 on PHQ-9; yes/no]), and HIV viremia (undetectable VL; yes/no).
15749976|NCT04860076|Drug|Pembrolizumab|Standard of care
15749977|NCT04860063|Drug|Berberine|Participants randomly assigned to the intervention group will be provided with Berberine 500 mg administrated per os three times a day for six months
15749978|NCT04860063|Drug|Placebo|Participants randomly assigned to the Placebo group will be provided with placebo administrated per os three times a day for six months
15749979|NCT04860050|Dietary Supplement|Turmipure Gold®|TPG: Turmipure GOLD® - 1 capsule per day - as prescribed
15749980|NCT04860050|Dietary Supplement|Placebo|Placebo: colored acacia gum - 1 capsule per day - as prescribed
15749981|NCT04860011|Drug|Dapagliflozin 10 MG Oral Tablet|Dapagliflozin 10mg once daily
15749982|NCT04860011|Drug|Metolazone Tablets|Metolazone 5MG or 10MG once daily
15749983|NCT04859998|Behavioral|dog-assisted therapy|It will consist of 20 sessions conducted twice a week in the facilities of the association. It will involve different activities and physical exercises facilitated by the dogs. The program will be conducted in two associations (12 participants in each one, 6 belonging to the experimental and 6 belonging to the control group in each association) and in groups of three participants.
15749984|NCT04859985|Device|SELUTION SLR|Patients randomized to the SELUTION SLR™ DEB arm will receive lesion preparation according to the 3rd DCB consensus (optimal balloon angioplasty with adjunct treatment using high-pressure balloon, shockwave, rotational atherectomy or cutting or scoring balloon at the discretion of the operator when necessary to maximize lumen diameter). Patients with lesions that are then best treated by provisional stenting (flow-limiting dissection, residual stenosis > 30% or FFR < 0.8) before or after use of DEB will receive a DES but remain in the SELUTION SLR™ DEB group (intention to treat analysis).
15750660|NCT04854694|Device|conventional surgical N95 respirator|standard N95 respirator
15749985|NCT04859985|Device|DES|For patients randomized to the DES strategy, all target lesions should be treated with DES, but use of a SELUTION SLR™ DEB or any other device is acceptable if a DES cannot be delivered to the target lesion. For bifurcation lesions, if the side-branch requires treatment it should be treated with another DES or with POBA, at the discretion of the operator, but not with a DEB.
15749987|NCT04859959|Diagnostic Test|Gallium-68 Pentixafor PET/CT|Intravenous injection of one dosage of 74-222 MBq (2-6 mCi) Gallium-68 Pentixafor. Tracer doses of Gallium-68 Pentixafor will be used to image adrenal lesions by PET/CT.
15749988|NCT04859946|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo stem cell transplant
15749989|NCT04859946|Drug|Busulfan|Given IV
15749990|NCT04859946|Drug|Cyclophosphamide|Given IV
15749991|NCT04859946|Drug|Fludarabine|Given IV
15749992|NCT04859946|Drug|Itacitinib|Given PO
15749993|NCT04859946|Drug|Tacrolimus|Given IV or PO
15749994|NCT04859946|Drug|Thiotepa|Given IV
15749995|NCT04859933|Procedure|AV-node isolation|Abaltion performed in the right atrium isolating the AV-node from the atrium
15749996|NCT04859933|Procedure|AV-node ablation|Right sided ablation of the AV-node
15749997|NCT04859920|Other|Questionnaires|QLQ-C30, SF-12, HADS, SARASON, EPICES, socio-professional data
15749998|NCT04859920|Other|Collection of clinical data and treatments|clinical data and treatments
15749999|NCT04859907|Device|Clamp-like system|Craniotomy closure
15750000|NCT04859907|Device|Plates and screws|Craniotomy closure
15750001|NCT04859894|Diagnostic Test|Physiological testing|Cardiopulmonary exercise testing, Lung Function Testing and in some cases echocardiography. 20 subjects will perform DNA-methylation testing.
15750002|NCT04859881|Other|No intervention|No intervention
15750003|NCT04859868|Device|Galvanic Vestibular Stimulation|Low electrical currents to the vestibular system.
15750004|NCT04859855|Procedure|Restrictive transfusional strategy|Transfusion of Red Blood Concentrates (RBCs) if Hb ≤7,0g/dL with the aim of maintaining Hb levels between 7,0-9,0g/dL.
15750005|NCT04859855|Procedure|Liberal transfusional strategy|Transfusion of RBC if Hb ≤9,0g/dL, with the aim of maintaining Hb levels between 9,0-10,0g/dL
15750009|NCT04859829|Other|Current Intravenous Immunoglobulin (IVIG) treatment|Questionnaires every two months for patients with a diagnosis of autoimmune dysmotility that are receiving Intravenous Immunoglobulin (IVIG) treatment.
15750010|NCT04859829|Other|No Intravenous Immunoglobulin (IVIG) treatment|Questionnaires every two months for patients with a diagnosis of autoimmune dismotility that are not receiving Intravenous Immunoglobulin (IVIG) treatment.
15750011|NCT04859816|Other|Metabolic test|Iv and oral administration of stable isotope tracers during fasting and a high-fat liquid mixed meal
15750012|NCT04859816|Other|DXA-scan|Dual energy X-ray Absorptiometry scan of whole-body fat
15750013|NCT04859816|Other|MRS|Magnetic resonance spectroscopy of liver fat content
15750014|NCT04859816|Other|Feces collection|4-day feces collection
15750015|NCT04859803|Drug|patients will receive rhomboid intercostal block under ultrasound guidance.|Following endotracheal intubation, patients allotted to the RIB group were positioned in the lateral decubitus position with the chest on the operating side lying superiorly. The ipsilateral arm was abducted from the chest to move the scapula laterally. The RIB was performed as described previously [8]. A high-frequency (6-12 MHz) linear ultrasound probe (LOGIQ e ultrasonic system, Deutschland GmbH & Co. KG, Solingen, Germany) was placed medial to the medial border of the scapula in the oblique sagittal plane. The landmarks, i.e., the trapezius muscle, rhomboid muscle, intercostal muscles, pleura, and lung, were identified in the ultrasound. Under aseptic conditions, an 80-mm 21-gauge needle was inserted at the level of T6-7 in the ultrasound view. A single dose of 30 ml 0.25% bupivacaine will be injected in the interfascial plane between the rhomboid major and intercostal muscles. The spread of the local anesthetic solution under the rhomboid muscle was visualized by ultrasonography.
15750016|NCT04859803|Drug|sham block|Following endotracheal intubation, patients allotted to the RIB group were positioned in the lateral decubitus position with the chest on the operating side lying superiorly. The ipsilateral arm was abducted from the chest to move the scapula laterally. The RIB was performed as described previously [8]. A high-frequency (6-12 MHz) linear ultrasound probe (LOGIQ e ultrasonic system, Deutschland GmbH & Co. KG, Solingen, Germany) was placed medial to the medial border of the scapula in the oblique sagittal plane. The landmarks, i.e., the trapezius muscle, rhomboid muscle, intercostal muscles, pleura, and lung, were identified in the ultrasound. Under aseptic conditions, an 80-mm 21-gauge needle was inserted at the level of T6-7 in the ultrasound view. A single dose of 30 ml saline will be injected in the interfascial plane between the rhomboid major and intercostal muscles. The spread of the local anesthetic solution under the rhomboid muscle was visualized by ultrasonography.
15750017|NCT04859790|Behavioral|Social Concerns Appraisal Retraining|"SCAR consists of an hour-long intervention session, followed by a 2-week-long EMI. During the hour-long intervention session, participants will receive psychoeducation (e.g., defining common terms like anxiety), discuss popular misconceptions they may have about publicly observable anxiety symptoms (e.g., people can tell I'm anxious by looking at me), and complete exposure exercises (e.g., practicing facing feared physical sensations such as sweating). During the EMI, participants will report on their social anxiety symptoms four times per day. When participants endorse elevated social anxiety during this time, they will receive a targeted message reminding them of the topics covered in the intervention session."
15750018|NCT04859777|Drug|MPT-0118|MPT-0118 is an inhibitor of MALT1 protease
15750021|NCT04859764|Drug|Corticosteroid injection|intraarticular knee injection of betamethasone and bupivacaine 0.5% (dose is determined by joint size)
15750022|NCT04859764|Device|Placebo knee sleeve|unlabeled compression knee sleeve
15750023|NCT04859751|Drug|VB4-845 Injection|Intravesical administration of VB4-845 Injection.
15750024|NCT04859738|Drug|Lidocaine Spray|"Individuals who met the research criteria and signed the informed consent form were numbered according to the order in which they came to the hospital. Later, the numbered individuals were assigned to the study groups according to the randomization list created in the computer environment.
~Lidocaine Spray was applied 60 seconds before to the area where the peripheral intravenous catheter application of the patients in the Experiment I Group (Lidocaine Spray) will be performed. After waiting 60 seconds, peripheral intravenous catheter application was performed.
~The nurse responsible for data collection measured blood pressure, pulse rate and peripheral oxygen saturation values 5 minutes before and just after the application with a finger-type pulse oximeter.
~After performing peripheral intravenous catheterization, the pain level felt by the individual during the procedure and the injection satisfaction level values were taken and recorded on the Case Report Form by the nurse."
15750025|NCT04859738|Drug|Benzokain Sprey|"Individuals who met the research criteria and signed the informed consent form were numbered according to the order in which they came to the hospital. Later, the numbered individuals were assigned to the study groups according to the randomization list created in the computer environment.
~Benzocaine Spray was applied 60 seconds before to the area where the peripheral intravenous catheter will be applied to the patients in the Experiment II Group (Benzocaine Spray). After waiting 60 seconds, peripheral intravenous catheter application was performed.
~The nurse responsible for data collection measured blood pressure, pulse rate and peripheral oxygen saturation values 5 minutes before and just after the application with a finger-type pulse oximeter.
~After performing peripheral intravenous catheterization, the pain level felt by the individual during the procedure and the injection satisfaction level values were taken and recorded on the Case Report Form by the nurse."
15750026|NCT04859738|Other|Alcohol|"Individuals who met the research criteria and signed the informed consent form were numbered according to the order in which they came to the hospital. Later, the numbered individuals were assigned to the study groups according to the randomization list created in the computer environment.
~In patients in the placebo group, alcohol was sprayed 60 seconds before the area where the peripheral intravenous catheter will be applied. After waiting 60 seconds, peripheral intravenous catheter application was performed.
~The nurse responsible for data collection measured blood pressure, pulse rate and peripheral oxygen saturation values 5 minutes before and just after the application with a finger-type pulse oximeter.
~After performing peripheral intravenous catheterization, the pain level felt by the individual during the procedure and the injection satisfaction level values were taken and recorded on the Case Report Form by the nurse."
15750027|NCT04859725|Device|Hyperspectral Imaging with Snapscan camera|Before, during and after the resection, HSI data ('datacubes') will be acquired by the SnapScan camera of all relevant areas of the exposed cortical surface and subcortical cavity walls. The exact points of which the datacubes will be acquired are defined by unequivocal single points on the routinely used neuronavigational system. From the points from which the datacubes have been obtained a corresponding tissue sample will be obtained (labeled biopsy) if tumor tissue is to be expected in that particular point, based on the current standard of care assessments intraoperatively using white light illumination on the microscope, intraoperative navigation and intraoperative ultrasound. As such, normally looking brain in the resection cavity wall, will only be biopsied if tumor free margins should be proven as part of the standard-of-care operative procedure (non-critically eloquent brain regions).
15750029|NCT04859686|Behavioral|Mindfulness-Based Stress Reduction|The MBSR program included weekly 2.5-hour sessions in a group format over eight weeks, plus a 1-day retreat. Formal practices included several types of meditation, such as mindful breathing, sitting meditation, walking meditation, gentle hatha yoga, body scan, and mindful awareness. Participants were asked to practice at home for 20 minutes daily, six days a week.
15750030|NCT04859686|Procedure|Acupuncture Treatment|"Participants received two treatments per week over eight weeks, 35-40 minutes each.
~At each treatment, participants were treated with 10 body and two ear points: seven major points on either the front or back of the body. The treatment position alternated between sessions, such that the first session was on the back, with the next session on the front, unless a physical limitation prevented alternation."
15750031|NCT04859673|Device|radial extracorpeal shock wave|Swiss DolorClast® Master - Shockwave Therapy System will be used to apply the radial extracorporeal shock wave. It consists of master console, Evo Blue hand-piece, 15mm and 36mm interchangeable contact heads (applicators), contact gel, cart, and external compressor
15750032|NCT04859660|Drug|Tamsulosin|Participants will be given Tamsulosin or placebo in the pre-op bay prior to surgery. Post-operatively, time to void and time to discharge from the post-anesthesia care unit will be recorded.
15750033|NCT04859660|Drug|Placebo|Participants will be given Tamsulosin or placebo in the pre-op bay prior to surgery. Post-operatively, time to void and time to discharge from the post-anesthesia care unit will be recorded.
15750034|NCT04859647|Other|Method of Levels Therapy|MOL is a flexible, client-led psychological therapy that allows people to talk freely about important problems and life goals.
15750035|NCT04859634|Device|Taking an ultra-widefield fundus image|The participant only needs to take an ultra-widefield fundus image as usual.
15750036|NCT04859621|Drug|Vitamin D3 4000 IU|Oral administration, 2 tablet per time, qd, oral administration with the first meal, continuous use for 48 weeks
15750037|NCT04859621|Drug|Vitamin D3 2000 IU|Oral administration, 1 tablet of each per time, qd, oral administration with the first meal, continuous use for 48 weeks
15750038|NCT04859621|Drug|Placebo|Oral administration, 2 tablet per time, qd, oral administration with the first meal, continuous use for 48 weeks
15750039|NCT04859621|Other|standard antibiotic therapy|standard antibiotic therapy
15750040|NCT04859608|Drug|Spacing of Eculizumab infusions|Personalized spacing of eculizumab infusions using a pharmacokinetic population model to estimate eculizumab concentration ( a one-week spacing of eculizumab infusion will be decide if predicted eculizumab concentration in the event of spacing is > 150 mg/L). Spacing of infusion can be decided every 3 months.
15791644|NCT04519658|Drug|Placebo|placebo tablets by mouth once daily
15750041|NCT04859595|Other|Telephone follow-up|"Monthly follow-up by telephone from M1 to M6. The interview will unroll in 2 stages, a first stage of discussion during which the speech therapist will take news of the patient. The second, more formal phase will be the opportunity to collect the data necessary for the validation of the primary and secondary outcomes. To do this, the speech therapist will use the Functional Oral Intake Scale (FOIS) score, the DHI and an interview grid.
~The interview will be conducted using an interview sheet previously written by the project team. The following elements will be discussed: the description of oral food intakes (TIMES), the perceived swallowing handicap (DHI), the instructions related to the diet and their daily application, ongoing rehabilitation follow-ups, notable events as well, then his emotional and psychological experience in relation to the disorder."
15750042|NCT04859582|Biological|Pembrolizumab|Administered as an IV infusion on Day 1 Q3W
15750043|NCT04859582|Drug|Cisplatin|Administered as an IV infusion on Day 1 Q3W
15750044|NCT04859582|Drug|5-fluorouracil|Administered as a continuous IV infusion on Days 1-5 Q3W
15750045|NCT04859582|Drug|Oxaliplatin|Administered as an IV infusion on Day 1 Q3W
15750046|NCT04859582|Drug|Capecitabine|Administered orally BID on Days 1 to 14 Q3W
15750047|NCT04859582|Drug|Placebo for Pembrolizumab|Administered as an IV infusion on Day 1 Q3W
15750048|NCT04859569|Drug|LY01011|subcutaneously (SC) once every 4 weeks (Q4W)
15750049|NCT04859569|Drug|Xgeva®|subcutaneously (SC) once every 4 weeks (Q4W)
15750050|NCT04859556|Device|Alcon 25Gauge, 10,000 cuts per minute Ultravit cutter|a proprietary Vitrector from Alcon for the use on the Constellation system
15750051|NCT04859556|Device|Alcon 25Gauge, 5,000 cuts per minute Ultravit cutter|a proprietary Vitrector from Alcon for the use on the Constellation system
15750052|NCT04859543|Device|FoundationOneHeme|Tumor tissue obtained during standard surgery will be subsequently examined histopathologically and the content of cancer cells will be determined. Broad molecular profiling of the tumor; with potential results finding such molecular changes, for which the specific targeted anti-tumor treatment will be performed.
15750053|NCT04859530|Diagnostic Test|AVC test|The AVC test will be performed during VIA by local midwives: 120 second videos focused on the cervix will be taken right after the application of acetic acid on the cervix. The recording smartphone will be fixed on a tripod situated 15cm away from the cervix.
15750056|NCT04859504|Device|transcranial alternating current stimulation (NE Starstim)|dual-channel theta-tACS over right DLPFC and cerebellum simultaneously
15750057|NCT04859491|Dietary Supplement|Carbohydrate|Participants have a one in three chance of consuming a carbohydrate beverage between two bouts of high-intensity exercise.
15750058|NCT04859491|Dietary Supplement|Carbohydrate-Protein|Participants have a one in three chance of consuming a carbohydrate-protein beverage between two bouts of high-intensity exercise.
15750059|NCT04859491|Dietary Supplement|Placebo|Participants have a one in three chance of consuming a placebo beverage between two bouts of high-intensity exercise.
15750060|NCT04859478|Diagnostic Test|Dual energy / spectral portal venous chest computed tomography|Each patient undergoes an additional dual energy / spectral chest CT in addition to standard care CTPA. The intervention is performed immediately after standard care CTPA.
15750061|NCT04859465|Drug|Abraxane combined with liposomal doxorubicin|Patients with advanced or unresectable angiogenic sarcoma who met the criteria of treatment failure received abraxane combined with liposomal doxorubicin regimen. Administration regimen: abraxane 220 mg / m2 D1 plus liposomal doxorubicin 35 mg / m2 D1, IV drip, 3 weeks as a cycle, until the disease progression or intolerable toxicity. Up to 8 cycles.
15750062|NCT04859452|Drug|DBPR108 tablets|Drug: DBPR108, tablet, oral
15750063|NCT04859452|Drug|Metformin hydrochloride tablets|Drug: Metformin hydrochloride, tablet, oral
15750064|NCT04859452|Drug|Glibenclamide tablets|Drug: Glibenclamide, tablet, oral
15750065|NCT04859452|Drug|Valsartan Capsules|Drug: Valsartan, capsule, oral
15750066|NCT04859452|Drug|Simvastatin tablets|Drug: Simvastatin, tablet, oral
15750067|NCT04859439|Drug|DBPR108 tablets|Drug: DBPR108, tablet, oral
15750068|NCT04859426|Drug|DBPR108 tablets|Drug: DBPR108, tablet, oral
15750069|NCT04859400|Dietary Supplement|Whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB)|The whey protein supplement high in leucine and β-hydroxy-β-methylbutyrate (HMB) is ingested once daily, preferably either in the evening before going to bed or within two hours after having finished exercising.
15750070|NCT04859400|Behavioral|Standardized nutritional program|During at least two personal counseling meetings with a dietician, the patient's diet is assessed and individual nutritional interventions - based on the personal needs and individual preferences of the patient - are developed. The overall goal is to optimize protein an energy intake.
15750071|NCT04859400|Behavioral|Standardized exercise program|In at least two personal counseling meetings with a physiotherapist, the patient's individual training plan is compiled and agreed upon (mainly including strength, endurance and balance exercises). The patient then exercises at home and records the trainings with the app.
15750072|NCT04859387|Other|set of pragmatic shoulder technique|Group A received pragmatic intervention which includes Pectoralis major and minor stretch, AC joint mobilization, rotator cuff facilitation for subscapularis and infraspinatus, serratus anterior stretch, thoracic manipulation and posterior capsular stretch.
15750073|NCT04859387|Other|traditional physical therapy|Group B received traditional interventions which includes modalities such as TENS and hot pack, soft tissue mobilization, joint mobilization, stretching and strengthening etc. other than pragmatic intervention
15750074|NCT04859374|Behavioral|Mindfullness|Behavioral approach (mindfulness) delivered on line and smart phone for 6 weekly sessions
15750075|NCT04859374|Drug|treatment as usual (TAU) (pharmacological)|Any pharmacological therapy used for managing chronic pain or chronic migraine
15750105|NCT04859114|Behavioral|Format of outcome data presentation|Outcome data is provided to participants as either text-only, a static pictograph, or an iterative pictograph.
15750106|NCT04859114|Behavioral|Displayed chance of survival|In the outcome data provided to participants, they view either a 30% or 60% chance of survival.
15750107|NCT04859101|Other|Gum|2 minutes of gum chewing prior to procedure
15750108|NCT04859101|Other|Control|2 swallows prior to procedure
15750076|NCT04859361|Drug|Aldara 5% Topical Cream|5% Imiquimod cream (1 sachet) will be administered via menstrual cup, before going to sleep, 3 times per week for 16 weeks. Menstrual cup will be inserted in the vagina for a duration of 6-8 hours. In case of severe side effects applications can be reduced to twice per week and if side effects are persistent, to once per week. For maximum control of cervical disease, control colposcopy with a PAP smear and a punch biopsy will be scheduled at 10 weeks to rule out progression, and at 20 weeks after treatment initiation to evaluate treatment success. At 20 weeks, biopsies will be performed at the locations where lesions were previously present, and if there are any new lesions present, additional biopsies will be performed. In case of disease progression or persistence, treatment with LLETZ will be offered.
15750077|NCT04859361|Procedure|LLETZ|LLETZ will be performed in an outpatient setting with local anesthesia, using KLS Martin Maxium with loop devices ranging from 10 mm to 20 mm in size. The excision will be performed using monopolar current with a cut frequency set to 100-150 W. Treatment success will be evaluated in accordance with our national guidelines 24 weeks after the procedure using a PAP smear with or without a punch biopsy.
15750078|NCT04859348|Other|routine physical therapy|G- A 36 participants received only routine treatment for GDM which includes insulin therapy and diet control guided by gynecologist and routine physical therapy which includes walk for 1 hr with proper warm up and cool down periods, three times in a week from 20-24 weeks of gestation to till delivery.
15750079|NCT04859348|Other|routine physical therapy and antenatal exercises|G- B 36 participants receive routine therapy (insulin therapy and diet control) and Aerobic and strengthening Exercises for 3 days a week, for 2 weeks 6 sessions under the supervision of physiotherapist and remaining was performed at home. Exercise was started from 15 min and reach to 30 mins gradually.10-15-minute warm-up, cool-down period was included by using ACOG Guideline. Aerobic exercise includes a brisk walk and strengthening exercise were performed with hold for 5 seconds and 10 repetitions. Exercise should stop if they experience any signs of dizziness, dyspnea, amniotic fluid leaking or vaginal bleeding. Confidentiality and blindness ensure by random allocation.
15750080|NCT04859335|Radiation|gammaknife radiosurgery|Patients will undergo questionnaires before the gammaknife radiosurgery, then one year and three years after the intervention.
15750081|NCT04859322|Drug|Glucagon|Pancreatic clamp
15750082|NCT04859309|Behavioral|ActiveHip+ mobile application|The mobile application with the educational and multidisciplinary tele-rehabilitation program.
15750083|NCT04859309|Procedure|Standard care in a hip fracture|The participants of this group will receive the standard treatment for a hip fracture in the Andalusian healthcare system.
15750089|NCT04859283|Drug|Dexmedetomidine|Intranasal dexmedetomidine 1µg/kg will be administered 30min before the induction of anesthesia using a LMA MAD Nasal-device
15750090|NCT04859283|Drug|Placebo|Intranasal saline (10 µL/kg) will be administered 30 min before the induction of anesthesia using a LMA MAD NasalTM -device. The dose is euvolemic to 1 µg/mL dexmedetomidine.
15750091|NCT04859244|Drug|GS-441524|750 mg administered as a solution
15750092|NCT04859231|Other|Control|Cow's milk-based formula
15750093|NCT04859231|Other|Investigational|Cow's milk-based formula with added source of enriched whey protein
15750094|NCT04859218|Procedure|RBC transfusion|two consecutive transfusion episodes: an ABO identical product at one transfusion episode and an ABO non-identical product for the other episode. The number of RBCs given for each study transfusion episode will be identical 2 RBC units.
15750095|NCT04859205|Behavioral|Intervention|"Participants will have access to the SUPPORT-Pro self-guided online training platform addressing many aspects of type 1 diabetes care. The SUPPORT-Pro content was developped by a team of health professionals specialized in type 1 diabetes as well as patient partners. It's content is regularly updated, evidence-based and divided into 6 categories (medication, blood glucose monitoring, diet, physical activity, hypo and hyperglycemia, health and other particularities). In each category, users can pick between 3 levels (beginner, intermediate and advanced) according to their level of confidence and knowledge.
~Participants will be asked to fill out questionnaires at baseline, 3-month, and 12-month of the intervention which include the following: Eligibility assessment, identification, background, confidence, platform satisfaction."
15750096|NCT04859192|Other|gamified flipped classroom|moodle will be gamified
15750097|NCT04859166|Procedure|Organoids|A part of the tumor of approximately 1 cm3 will be removed from the primary tumor.
15750098|NCT04859153|Diagnostic Test|central nerve sensory, motor control and various muscle mechanical characteristic and sport-related fitness test|To explore the sports performance of the adolescent sprinters, including analyzing the correlations between the results and central nerve sensory, and also between motor control and various muscle mechanical characteristic and sport-related fitness factor.
15750099|NCT04859140|Other|Psychometric ratings (Likert-scale)|Self-report of perceived anxiety and physical sensations (muscle pain, relaxation and warmth)
15750100|NCT04859140|Behavioral|Range of motion measures|Sit-and-reach and toe touch tests
15750101|NCT04859140|Behavioral|Mental calculation task|Iterated substractions (for 2 minutes)
15750102|NCT04859140|Device|Resting-state electroencephalography|Alpha and beta oscillation power (4 minutes recordings)
15750103|NCT04859140|Device|Resting-state galvanic skin resistance measures|Skin conductance during the resting state period
15750104|NCT04859127|Other|effects of neck pain|Within the scope of the evaluation for the assessment of pain by visual analog scale (VAS), standard evaluation posture Postural Analysis, range of motion for the evaluation of Elektrogonyometer, Nov stabilizer and force evaluation for a hand-held Dynamometer, Nov for brevity, brevity reviews left internal rotator muscles of the pectoral muscles with standard, fear of movement kinezyofobi Tampa scale for the assessment of the neck in apology, questioning of the status of the inquiry Neck Disability Survey, stars in the evaluation of balance dynamic balance test, stand on one leg Test in the evaluation of static balance, dynamic balance and physical performance Term rise and walk test, gait speed for the assessment of the 10-meter walk test and dual-task for the evaluation of the motor-the motor and motor-Cognitive dual-task will be used for the evaluation.
15750109|NCT04859088|Dietary Supplement|Partial Enteral Nutrition|Dietary intervention (Liquid food replacement intervention)
15750112|NCT04859049|Procedure|infromedial single injection|only single needle entry & injection to have anesthesia done
15750113|NCT04859036|Diagnostic Test|24 hours ambulatory Holter monitoring|
15750114|NCT04859023|Diagnostic Test|saliva sample combined to an anterior nare self-swabbing (Self-samples)|Tested by antigenic test.
15750115|NCT04859023|Diagnostic Test|saliva sample (Self-sample)|Tested by RT-PCR.
15750116|NCT04859023|Other|Survey of SARS-COV-19 knowledge|collection of : socio-professional characteristics, questions on health literacy on the transmission of the virus and barrier gestures, adherence to barrier gestures, isolation modalities in case of positivity, motivations for participating in this screening campaign.
15750117|NCT04859023|Other|Survey of acceptability of the different self-samples.|collection of : assessment and acceptability of the tolerance of self-samples.
15750118|NCT04858997|Drug|Palbociclib|Palbociclib,125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
15750119|NCT04858997|Drug|AI|AI, orally once daily (continuously)
15750120|NCT04858984|Device|Virtual Reality|A portable, standalone VR headset called Oculus Go (Facebook Technologies, LLC. 1601 Willow Road, Menlo Park, CA 940250) with a head-mounted display with built in audio drivers was used. Disposable hygiene masks and a surgical cap were used as an underlay below the headset an
15750121|NCT04858971|Other|Perception of information source|Participants will see the same health advice, with no source or one of three other sources indicated
15750122|NCT04858958|Drug|Furmonertinib 160mg|randomized to 160mg QD
15750123|NCT04858958|Drug|Furmonertinib 240mg|randomized to 240mg QD
15750125|NCT04858932|Device|Continuous Glucose Monitor|a handheld reader and a wearable sensor placed on the back of the arm used to obtain glucose measurements
15750126|NCT04858932|Device|Wrist Actigraphy Device|a watch like wearable sensor
15750127|NCT04858932|Device|Food Weight Scale|a scale to measure food weight
15750128|NCT04858932|Device|Smart Body Weight Scale|a full body composition scale that provides fat and muscle mass, water retention, bone mass, and weight trends
15750129|NCT04858919|Diagnostic Test|3D transabdominal ultrasound|Initially 3D pelvic ultrasound will be performed on all patients. The transabdominal probes used will be those of the ultrasound scanner using a convex probe (multiple frequency 1-6 MHz).
15750130|NCT04858919|Diagnostic Test|transrectal ultrasound|The vaginal probe will be covered with the customary plastic sheath and richly lubricated with lubricating gel. The probe will then be slowly advanced into the rectum. The transvaginal probes used will be those of the ultrasound scanner using a vaginal probe (multiple frequency 1-8 MHz). The scanning technique will be similar to that of Transvaginal ultrasound.
15750131|NCT04858919|Diagnostic Test|vaginoscopy|It is the final procedure in the study to reach the accurate diagnosis. A rigid hysteroscope will be used. The sheath has a 5-mm outer diameter, with 2.9 mm rod lens. A high intensity light source and fiberoptic cable will be used to illuminate the uterine cavity. A solution of 0.9% normal saline will be used as the distention medium. The pressure will be kept at 100-120 mmHg using a pressure adjustable cuff system with the aim of maintaining the lowest pressure required to distend the uterine cavity.
15750132|NCT04858906|Device|McGrath laryngoscope|The patients in this group will be evaluated and intubated with McGrath laryngoscope (angulated videolaryngoscope).
15750133|NCT04858906|Device|C-MAC D-blade laryngoscope|The patients in this group will be evaluated and intubated with C-MAC D-blade laryngoscope (hyperangulated videolaryngoscope).
15750134|NCT04858893|Diagnostic Test|CoMDA associated with Neural Net 91 classificator|
15750135|NCT04858880|Radiation|Radiation to the prostate bed with or without addition of radiation of lymph node irradiation.|Radiation to the prostate bed with or without addition of radiation of lymph node irradiation (non responders). Patients with PSA response continues radiotherapy as initially planned, and are not followed according to the study protocol, only according to clinical practice.
15750136|NCT04858867|Radiation|rhTSH-stimulated I-124 dosimetry|"Preparation:
~Low iodine diet 7 days prior to I-124 ingestion until 24 hours post-ingestion
~Thyrogen injections 24 and 48h prior to I-124 ingestion
~Procedures following Jentzen et al:
~Ingestion of capsule with 37±10% MBq I-124
~I-124 PET/CT at 24 and 96h post-ingestion
~Blood draws at 2, 24 and 96h post-ingestion
~Whole body counting at 2, 24 and 96h post-ingestion"
15750137|NCT04858867|Radiation|Intra-therapeutic I-131 dosimetry|"Procedures following EANM guidelines:
~I-131 SPECT/CT at 2, 6, 24, 96 and 144h post-ingestion
~Blood draws at 2, 6, 24, 96 and 144h post-ingestion
~Whole body counting at 2, 6, 24, 96 and 144h post-ingestion"
15750139|NCT04858841|Drug|Levetiracetam Oral Product|Administer levetiracetam powder once a day in eligible patients
15750140|NCT04858841|Drug|Perampanel Oral Product|Administer perampanel powder once a day in eligible patients
15750141|NCT04858841|Drug|Placebo|Administer placebo powder once a day in eligible patients
15750142|NCT04858815|Behavioral|yogic breathing|participation in yogic breathing
15750143|NCT04858802|Device|PROPEL Contour Sinus Implant|370 mcg mometasone furoate-coated sinus implant
15750144|NCT04858802|Procedure|Balloon Sinus Dilation Alone|No sinus implant
15750834|NCT04853225|Other|Prospective observational cohort study|Prospective observational cohort study
15750145|NCT04858789|Behavioral|Culturally Adapted Cognitive Behavioral Intervention (CA-CBI)|CA-CBI is an intervention based on Culturally Adapted Cognitive Behavioral Therapy (CA-CBT) which was developed by Devon Hinton. This transdiagnostic intervention has a structured manual which can be culturally adapted and it will be used to decrease psychological distress and increase well-being by targeting cognitive and behavioral changes.
15750146|NCT04858776|Combination Product|Perivascular dexamethasone|Dexamethasone delivery around target vein segment(s)
15750147|NCT04858776|Combination Product|Perivascular sham|Saline delivery around target vein segment(s)
15750148|NCT04858763|Other|No Intervention|There will be no intervention during this study.
15750149|NCT04858750|Device|Placement of ureteral D-J stent after ureteroscopic holmium laser lithotripsy|During ureteral holmium laser lithotripsy operation, after the stones were fragmented, the D-J stents of three different types were placed, the insertion process are exactly the same.
15750150|NCT04858737|Behavioral|e-predictD-Work intervention|The intervention is based on validated risk algorithms to predict depression and includes: 1) Mobile applications as main user's interface; 2) a DSS that helps worker participants to develop their own personalized plans to prevent (PPP) depression; 3) nine intervention modules (the core of the system) including activities to prevent depression, to be proposed by the DSS and chosen by the participants. The intervention is biopsychosocial and multi-component, including the following modules: physical exercise, improve sleep, expand relationships, solve problems, improve communication, assertiveness, decision making, manage thoughts and reduce work stress. Worker participants will implement the recommendations and the tool will monitor these actions, offering feedback to improve their PPP at 6 and 12 months.
15750151|NCT04858737|Other|Brief psychoeducational messages|The intervention consists of an App that weekly send short messages about stress and general health that will be extracted from brochures and websites of official agencies.
15750154|NCT04858698|Device|Ultrasound / Echocardiography|Ultrasound will be used to guide vascular access and to place a lead into the right ventricle.
15750155|NCT04858685|Other|early mobilization|early mobilization was defined, on the basis of the ERAS protocol, as mobilization of a few steps or a few meters from the bed within the first 24 hours after surgery with another person's support/control and/or a walking aid.
15750156|NCT04858659|Drug|PK101|1 tablet at each time, 2 times a day
15750157|NCT04858659|Drug|PK101-002|1 tablet at each time, 2 times a day
15750158|NCT04858659|Drug|PK101 placebo|1 tablet at each time, 2 times a day
15750159|NCT04858659|Drug|PK101-002 placebo|1 tablet at each time, 2 times a day
15750160|NCT04858646|Other|Experimental( Group A ): Aerobic exercises|Subjects in A group was treated with different types of aerobic exercises such as 10 minute walking, 10 minute trampoline exercise and 10 minutes ball throwing activities
15750161|NCT04858646|Other|Conventional( Group B): Conventional Physical therapy|The group B was treated with conventional therapy. Conventional treatment protocol passive ROM and stretching passive ROM for 15 minutes and stretching for 15 minutes.Treatment duration for both groups will be 30 minutes. Each subject received total30sessions of the treatment, with 5 treatment sessions per week for 6 weeks
15750162|NCT04858633|Drug|Hydroxychloroquine (HCQ)|Tablet HCQ 400 mg q 12 hourly on day one followed by 400 mg once weekly for 3 weeks (total 5 tablets, cumulative dose of 2000 mg )
15750163|NCT04858633|Other|Standard care|Standard therapy in the form of home quarantine for 2 weeks along with social distancing and personal hygiene
15750164|NCT04858633|Other|Placebo|Tablet placebo one tablet 12 hourly on day one followed by one tablet once weekly for 3 weeks (total 5 tablets)
15750165|NCT04858620|Drug|Xlear Nasal Spray|Xylitol plus Grapefruit Seed Extract (Xlear) nasal spray, 2 puffs per nostrils, every 6 hours
15750166|NCT04858620|Drug|Placebo|Saline nasal spray, 2 puffs per nostrils, every 6 hours
15750167|NCT04858607|Diagnostic Test|Blood sample|Serology, immune status, T cell immunity, and T cell aging.
15750168|NCT04858607|Diagnostic Test|Saliva sample|Antibody tests
15750169|NCT04858594|Other|Planned Chemotherapy|standard oncologic supportive care including antibiotic prophylaxis
15750170|NCT04858581|Diagnostic Test|Virological and serological tests|Survey, RT-PCR test and blood test
15750171|NCT04858542|Behavioral|Educational Vocal Health Modules|We have developed four educational health modules (total duration of approximately 30 minutes). First, these modules explain how masks impact communication and voice, then they describe health strategies to improve communication and voice, and finally, they give real-life examples of how the strategies can be implemented into the work setting.
15750172|NCT04858529|Drug|docetaxel/carboplatin/trastuzumab/pertuzumab (TCHP)|docetaxel/carboplatin/trastuzumab/pertuzumab (TCHP)
15750173|NCT04858529|Drug|docetaxel/trastuzumab/pertuzumab (THP)|docetaxel/trastuzumab/pertuzumab (THP)
15750174|NCT04858516|Drug|palbociclib and exemestane plus trastuzumab and pyrotinib|Neoadjuvant treatment with palbociclib and exemestane plus trastuzumab and pyrotinib in ER-positive, HER2-positive breast cancer
15750175|NCT04858503|Other|internet-based cardiac rehabilitation enhancement intervention|Participants in the intervention group will receive a 12-week i-CARE intervention, which will be designed to cover the core elements of CAD self-care: self-care maintenance, self-care monitoring and self-care management. The intervention will comprise: 1) a single individualized face-to-face session and 2) an internet-based intervention through a mobile application. Various behaviour change techniques will be used to increase the self-efficacy of CAD patients in enacting self-care behaviours.
15750176|NCT04858490|Drug|Diazepam|Symptom-triggered diazepam treatment: 10 or 20mg, at the clinician's discretion
15750177|NCT04858477|Other|Visual estimation of polyp size|For each colonoscopy, a fellow will first visually estimate the polyp size
15750265|NCT04857814|Device|ADAMM- RSM Device|All participants will wear the ADAMM- RSM device for a 6 month period
15750178|NCT04858477|Other|Napoleon measurement of polyp size|For each colonoscopy, a fellow will first visually estimate the polyp size and then measure the polyp with Napoleon. The Micro-Tech Endoscopic Polyp Measurement Device named Napoleon is a small catheter with a 15mm ruler calibrated at 1mm intervals with 5mm demarcations. It is classified as a Class 1, 510(k) exempt device by the FDA.
15750179|NCT04858464|Other|Survey study|Patients will complete the mentioned questionnaires.
15750180|NCT04858451|Drug|RESP301|"A single RESP301 dose administered at a study site to assess tolerability.
~In patients who experience a flare-up during the study period, self-administered RESP301 treatment for 7 days, 3 times a day."
15750181|NCT04858438|Procedure|Insufflation during surgery|This is the amount of insufflation using during the surgical procedure.
15750184|NCT04858412|Dietary Supplement|β-hydroxy β-methyl butyrate (HMB) enriched amino acid|β-hydroxy β-methyl butyrate (HMB) is a non-nitrogenous leucine metabolite with anabolic properties.
15750185|NCT04858412|Dietary Supplement|Balanced amino acid|Balanced amino acid is the balanced mixture of the various essential amino acids.
15750186|NCT04858399|Diagnostic Test|Evaluation|To examine the differences in respiratory functions, orofacial muscle tone changes, anxiety/ depression, and quality of life of the patients according to the severity of Obstructive Sleep Apnea Syndrome.
15750187|NCT04858373|Other|Glucose as reference food|Fourteen healthy, normal weight subjects (male: 6, female: 8) after 10-14 hr fast, consumed 50g glucose diluted in 300ml water, tested three times, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
15750188|NCT04858373|Other|Emmer bread from Greek emmer|Fourteen healthy, normal weight subjects (male: 6, female: 8) after 10-14 hr fast, consumed 50g available carbohydrates from Greek emmer bread, tested once, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
15750189|NCT04858373|Other|Emmer bread from Italian emmer|Fourteen healthy, normal weight subjects (male: 6, female: 8) after 10-14 hr fast, consumed 50g available carbohydrates from Italian emmer bread, tested once, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
15750190|NCT04858373|Other|Whole wheat commercial bread|Fourteen healthy, normal weight subjects (male: 6, female: 8) after 10-14 hr fast, consumed 50g available carbohydrates from whole wheat commercial bread, tested once, in different visits, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
15750191|NCT04858360|Drug|Emla 1 hour|At the start of each session, the middle forearms of the subject will each be divided into two squared areas (4x4 cm). On each arm, the two areas will be located 4 cm apart. Then one area will be pre-treated with cutaneous 2.5% lidocaine/2.5% prilocaine cream (EMLA cream) for 1 hour.
15750192|NCT04858360|Drug|EMLA 3 hours|At the start of each session, the middle forearms of the subject will each be divided into two squared areas (4x4 cm). On each arm, the two areas will be located 4 cm apart. Then one area will be pre-treated with cutaneous 2.5% lidocaine/2.5% prilocaine cream (EMLA cream) for 3 hours.
15750193|NCT04858360|Other|Vehicle cream for 1 hour|At the start of each session, the middle forearms of the subject will each be divided into two squared areas (4x4 cm). On each arm, the two areas will be located 4 cm apart. Then two area will be pre-treated with a vehicle cream for 1 h.
15750194|NCT04858360|Other|Vehicle cream for 3 hours|At the start of each session, the middle forearms of the subject will each be divided into two squared areas (4x4 cm). On each arm, the two areas will be located 4 cm apart. Then two area will be pre-treated with a vehicle cream for 3 h.
15750195|NCT04858360|Other|Cowhage|Cowhage spicules are 1-2 mm in length and have a diameter of 1-3 μm. The spicules are inserted by gently rubbing 30-35 spicules into a 1 cm diameter skin area.
15750196|NCT04858347|Device|Total knee replacement|Implantation of the GEMINI SL Fixed Bearing PS knee prosthesis. The operation technique of the GEMINI SL Fixed Bearing PS knee prosthesis will be followed.
15750199|NCT04858321|Procedure|Passive heating|8-12 x1 h water immersion (to the clavicle, @40 °C, rectal temperature ~38.5 °C and <39 °C) sessions over a period of 14 days.
15750200|NCT04858308|Drug|YYC506|YYC506
15750201|NCT04858308|Drug|Control|Active control
15750202|NCT04858308|Drug|YYC506 Placebo|Placebo
15750203|NCT04858308|Drug|Control Placebo|Placebo
15750204|NCT04858295|Device|Texting|The Way to Health platform is an automated information technology platform that integrates wireless devices, clinical trial randomization and enrollment processes, messaging (text, e-mail, voice), self-administered surveys, and secure data capture for research purposes. Way to Health has been used successfully in prior behavior intervention studies.
15750205|NCT04858295|Device|mHealth app|Omron Connect app available on a participant's smartphone connects to the participant's home Omron blood pressure monitor via bluetooth technology. The Omron Connect app, which stores the blood pressure readings and provides reminders to the participant via push notifications also communicates with the Way to Health research platform via Internet connection.
15750206|NCT04858282|Other|mobile application (BC-SDM)|"The mobile application (BC-SDM)includes four functions to support SDM activity: Understanding breast cancer, Surgical approach, Choose the right breast cancer knowledge, and Let's make a decision for myself. Patients first read the information in Understanding breast cancer and Surgical approach to receive a tailored education in breast cancer"
15750207|NCT04858269|Drug|Pembrolizumab|Pembrolizumab 200 mg intravenously (IV) on day 1 of each 3-week cycle
15750208|NCT04858269|Drug|Carboplatin|Carboplatin dosed for area under the curve (AUC) 1 IV on days 1, 8, 15 of each 3-week cycle
15750209|NCT04858269|Drug|Paclitaxel|Paclitaxel 25 mg/m2 on days 1, 8, 15 of 3-week cycle.
15750210|NCT04858256|Drug|Pacritinib|Pacritinib will be dosed at 200mg twice daily.
15750211|NCT04858243|Other|Home-Based ART|Community-based male-specific counseling followed by home-based ART initiation (or at any location that is convenient for participants) and home-based ART continuation for a 3-month period, followed by linkage to a local health facility for further ART continuation.
15750266|NCT04857801|Drug|Teduglutide|effect of teduglutide on intestinal rehabilitation
15750212|NCT04858243|Other|Facility-Based ART|Community-based male-specific counseling followed by linkage to a local health facility for ART initiation and continuation.
15750213|NCT04858230|Device|LymphoPilot|"LymphoPilot is an investigational medical device composed of an implanted part (pump, drainage catheter and output catheter), implanted in the subcutaneous tissue of the arm and draining excess fluids to the supraclavicular subcutaneous tissue, where fluids are naturally reabsorbed by the healthy lymphatic and venous system. The implanted part is activated and controlled via a wearable device.
~The subcutaneous implantation of the device is performed in loco-regional anesthesia, in ambulatorial settings, and the patient is dismissed from the hospital on the same day of the procedure.
~The device is activated in the postoperative room by placing the external wearable device on patient's arm area, in proximity of the implanted pump. Patients will wear the external controller continuously throughout the study, except 30 minutes per day, to allow taking a shower/bath. The implanted device will be removed with a surgical procedure in local anesthesia 8 weeks after device implantation."
15750214|NCT04858178|Diagnostic Test|Tests of sympathetic inhibition|Bolus phenylephrine infusion using the Oxford technique will generate the need to inhibit sympathetic activity. Similarly, resting state Mayer waves will be assessed with regard to heart rate and blood pressure responses.
15750215|NCT04858178|Diagnostic Test|Tests of sympathetic activation|Cold pressor test of the hand will be used to cause sympathetic activation. Valsalva's maneuver will assess the ability to buffer against blood pressure fall (phase II).
15750216|NCT04858178|Diagnostic Test|Testing of autonomic dysreflexia|Cold pressor test of the foot and bladder pressor response (in individuals with SCI) will be tested.
15750217|NCT04858178|Device|Transcutaneous spinal cord stimulation|Transcutaneous spinal cord stimulation will be applied at T7-L1 spinal segments to assess alterations in autonomic neuroregulation.
15750218|NCT04858165|Procedure|MY GERYFS PROTOCOL|The MY GERYFS will be introduced through a guideline document, dissemination through the department of nursing, notices on the intranet and provision of large signs indicating that MY GERYFS are in progress and the times of meals for each ward. The developed protocol in phase 1 and 2 will be tested in single-centre in a before and after study for its feasibility and safety. In the pre-study, patients will be given usual care. In the post-study, patients will care according to the developed protocol. Clinical outcomes such as malnutrition risk, medical background, anthropometry data, nutrition-focused physical findings, dietary intake, mealtime barrier, Hospital Foodservices satisfaction will be recorded.
15750219|NCT04858152|Procedure|Follicular Unit Extraction via punch biopsy|Follicular unit extraction will be performed using standard 0.7mm - 1mm punch biopsies. The donor site, which will be selected as a vitiligo-free, hair-bearing area that is not visible per patient's preference, will be harvested via punch biopsies and transplanted to the recipient site, which will be the glabrous skin of the hands or feet.
15750220|NCT04858139|Drug|Lactate|Intravenous injection (20 min), 300 mmol/L, 1mmol/Kg body weight,
15750221|NCT04858139|Drug|Placebo|Intravenous injection (20 min)
15750222|NCT04858126|Device|ECOM cardiac output|Measure cardiac output during perioperative period and compare to pulmonary artery catheter thermal dilution cardiac output measurement.
15750223|NCT04858113|Other|Blephaclean|Blephaclean wipes are used to help treat symptoms of blepharitis (eyelid inflammation) which is commonly associated with dry eye disease and meibomian gland dysfunction.
15750224|NCT04858113|Other|Baby Shampoo|Conventional baby shampoo
15750225|NCT04858100|Procedure|Surgical excision of the lesion|"The surgical removal of the lesion will follow these steps:
~local anesthesia
~excision of the lesion with surgical blade or laser, according to the clinical case, paying attention to having 5 mm-free margins
~silk or resorbable suture for wound closure
~The patient will be recall after 14 days for assessing the wound healing and after 30 days for providing and explaining him the histopahtological exam.
~The patient will receive a 3-6 month follow-up according to the clinical and histopathological case."
15750226|NCT04858100|Other|Wait and see approach|The patient will receive a 3-6 month follow-up according to the clinical and histopathological case, with periodical incisional biopsy every 4 control visit.
15750227|NCT04858087|Other|Screening and treatment|Students were screened by mRDTs and treated with artemether-lumefantrine if positive
15750228|NCT04858074|Drug|Hypoestoxide|Its active pharmaceutical ingredient (API) is Hypoestoxide, discovered in 1983, which was recently shown to be active against alpha synuclein and was very effective in modifying disease progression in a transgenic mouse model of PD
15750231|NCT04858048|Procedure|Anesthesia|2 types of anesthesia (general and WALANT) performed during the surgery
15750232|NCT04858035|Behavioral|Perceptual training|"Perceptual training involves self-paced presentation of auditory stimuli via a computerized software program.
~Stimuli are organized into three separate tasks:
~Tasks 1 and 3 will train category goodness judgment: Participants will hear 75 naturally produced speech tokens containing /r/ from various speakers, with a balance of correct and incorrect productions. They will classify each /r/ as correct or incorrect and receive feedback on the accuracy of their classification. Tasks 1 and 3 differ in that task 1 will feature a subset of items designed to provide focused practice on a specific context (e.g., initial /r/ as in red; /r/ as syllable nucleus as in sir), with increasing difficulty over time, whereas task 3 will feature randomly selected items representing all contexts and difficulty levels.
~Task 2: Participants will hear 75 items drawn from the synthetic rake-wake continuum used in the identification task administered at baseline."
15750233|NCT04858035|Behavioral|Production training|"Instruction: Discuss tongue shapes for /r/. Pre-practice: relatively unstructured, highly interactive elicitation; provide models and placement cue and KP on every trial.
~Structured syllable practice: Practice will occur in blocks of 10 consecutive trials on the same syllable (e.g., 10 /ra/), after which a new syllable will be addressed (e.g., 10 /re/--but note that in the fully blocked condition, the same syllable should occur in two consecutive blocks of 10)."
15750267|NCT04857788|Other|Pandah Application smartphone only|Patients will have an application on their smartphone to help them do their homework
15750353|NCT04857047|Drug|BR9003 2mg|After fasting for at least 10 hours from 10:00 p.m. the previous day, one BR9003 tablet will be administered orally with 150mL of water around 8:30 a.m. after starting breakfast 30 minutes before the scheduled time of administration and finishing it.
15750234|NCT04858022|Behavioral|Visual Acoustic Biofeedback|In visual-acoustic biofeedback treatment, the elements of traditional articulatory treatment (i.e., auditory models and verbal descriptions of articulator placement) are enhanced with a dynamic display of the speech signal in the form of the real-time LPC (Linear Predictive Coding) spectrum. Because correct vs incorrect productions of /r/ contrast acoustically in the frequency of the third formant (F3), participants will be cued to make their real-time LPC spectrum match a visual target characterized by a low F3 frequency. They will be encouraged to attend to the visual display while adjusting the placement of their articulators and observing how those adjustments impact F3.
15750235|NCT04858022|Other|No treatment - waitlist|10-week period of no treatment
15750236|NCT04858009|Drug|Cisplatin|Given via HIPEC
15750237|NCT04858009|Drug|Hyperthermic Intraperitoneal Chemotherapy|Undergo HIPEC with mitomycin and cisplatin
15750238|NCT04858009|Drug|Mitomycin|Given via HIPEC
15750241|NCT04857983|Drug|Memantine|Subjects will be assigned to take memantine or placebo and will complete 30 hours of targeted cognitive training in order to assess whether memantine enhances cognitive training performance
15750242|NCT04857983|Drug|Placebo|Subjects will be assigned to take memantine or placebo and will complete 30 hours of targeted cognitive training in order to assess whether memantine enhances cognitive training performance
15750243|NCT04857970|Other|Electronic HRQoL questionnaires with feedback to physicians|Use of the CHES software for HRQoL collection and graphical display of the patients' HRQoL scores to physicians
15750244|NCT04857970|Other|Paper-pencil HRQoL questionnaires w.o. feedback to physicians|Use of paper-pencil HRQoL questionnaires, the results of which are not presented to physicians
15750245|NCT04857957|Drug|Oral dose CNTX-6016 or oral dose Placebo|CNTX-6016 or Placebo
15750246|NCT04857944|Behavioral|IDEA program (Improving depressive symptoms through personalised exercise and activation)|The program will consist of six 90-minute group sessions composed of four to six participants. These short intervention sessions will be distributed in one month, with a frequency of once or twice a week depending on the week of the program. Of the six sessions, two will be exercise-oriented and will include on-site practice. The remaining four sessions will include definitions of depressive symptomatology, the relationship between depression and having an active lifestyle, motivation and barriers towards exercise, and maintenance strategies.
15750247|NCT04857944|Device|IDEApp|An ad-hoc app (IDEApp) combined with a fitness tracker to register and store participants' physical activity, exercise compliance, and sleep patterns. The app will deliver motivational or awareness messages when the fitness tracker detects non-compliance with the exercise prescription, physical activity decreases, or altered sleep patterns.
15750250|NCT04857918|Behavioral|Virtual running group program|The intervention will include an eight-week virtual running group program hosted on online platforms such as Zoom and the fitness application Strava. Participants will be placed in running groups of 6 people, and each running group will have the collective goal to run/walk the distance across the province of B.C., (940 km) and will meet weekly over Zoom to socialize and discuss running topics and their progress towards the group goal. Participants will receive a t-shirt with the STRIDE logo and a phone armband for carrying their smart phone during runs and walks.
15750251|NCT04857918|Behavioral|Attention Control: Fitness Application Strava|The attention control condition will be instructed to record their exercise using the Strava application, and will be encouraged to participate in 150 minutes of moderate-to-vigorous exercise each week of the intervention.
15750252|NCT04857905|Procedure|Microsurgical resection|Depending on the patient's choice, the microsurgical resection of the brain metastases will be performed.
15750253|NCT04857905|Procedure|Gamma Knife radiosurgery|Depending on the patient's choice, the radiosurgical treatment of the brain metastases will be performed.
15750254|NCT04857892|Drug|GSK3640254|GSK3640254 will be administered via oral route.
15750255|NCT04857892|Drug|DTG|DTG will be administered via oral route.
15750256|NCT04857892|Drug|GSK3640254/DTG|GSK3640254/DTG will be administered via oral route.
15750257|NCT04857879|Other|GLA:D program (Good Life with osteoArthritis in Denmark)|GLA:D includes disease-specific education combined with neuromuscular exercises. Control interventions include disease-specific education combined with exercises to optimize movement and strength of the affected knee.
15750258|NCT04857866|Drug|XmAb27564|Single ascending dose of XmAb27564
15750259|NCT04857866|Drug|Placebo|Single dose of placebo
15750260|NCT04857853|Other|Exercise Without Rest Break|"Participants in the exercise group will receive 'Exercise Breaks', of 10 minutes, twice a day during the work hours, in addition to the two 'Conventional Rest Breaks' of 15 minutes, twice a day during the work hours.
~Exercises include shoulder shrugs, neck tilts, wrist and forearm stretch, back and hip stretch, upper body stretch, hamstring stretch, upper back stretch, hand/finger stretch. Side stretch and neck stretch.
~Follow up 3 times a week for 5 weeks."
15750261|NCT04857853|Other|Exercise With Rest Break|"Participants in the exercise with rest break group will receive 'Exercise Breaks', of 10 minutes, twice a day during the work hours, in addition to the two 'Conventional Rest Breaks' of 15 minutes, twice a day during the work hours.
~Participants will also receive 'Supplemental Micro Breaks', of 30 seconds after every 15 minutes of working on a static computer workstation Follow up 3 times a week for 5 weeks."
15750262|NCT04857853|Other|Rest Break|"Participants in the rest breaks group will receive 'Supplemental Micro Breaks', of 30 seconds after every 15 minutes of working on a static computer workstation in addition to the two 'Conventional Rest Breaks' of 15 minutes twice a day during the work hours.
~Follow up 3 times a week for 5 weeks. During the rest breaks, participants will not perform any exercises."
15750263|NCT04857840|Drug|Firibastat (QGC001) Period 1|1000 mg (2 x 500 mg) tablets QD per Os
15750264|NCT04857827|Drug|QLS-101|Ophthalmic solution daily dosing for 14 days.
15750268|NCT04857775|Behavioral|Attachment and Child Health (ATTACH) Parenting Program|ATTACH™ provides parent training to address Reflective Function (RF) of parents affected by a broad array of toxic stressors. RF, defined as the ability to have insight into one's own and one's child's mental states, feelings, thoughts and intentions, underpins parental sensitivity and responsiveness and is undermined by the experience of current or past stress. Parents require high RF to respond sensitively/appropriately to their children and thus promote secure parent-child attachments, essential for child MEB health. ATTACH™ consists of 10-12 ~45-minute clinic visits with dyadic (mother and infant) and triadic (mother, infant, and co-parent) elements, with a trained facilitator, who may be a nurse, social worker or other allied health professional.
15750269|NCT04857749|Other|Standard care|As a pre-test to the patients in the group just before starting treatment; Informed Consent Form, Patient Identification Form, CTCAE v5.0 toxicity criteria, Quality of Life Scale will be applied. At the end of the seven weeks, the post-test (measurement tools included in the pre-test) will be applied.
15750270|NCT04857749|Other|Navigation Nursing|With the role of navigator, the nurse contributes to increase the quality of care and to positively affect the physical, psychological and social well-being of the patient. Navigator nurses address patient barriers to care that are complex and often not easily resolved. As a result of the navigation nurses participating in care in the field of oncology; Providing assistance to the side effects of cancer and its treatment, including symptom preventive measures, supporting communication between individuals participating in treatment, preventing delays in treatment, explaining the language of medical treatment, providing psychosocial support, defining and recommending resources.
15750271|NCT04857710|Device|Wide-pulse neuromuscular electrostimulation (WP NMES)|The WP NMES program consists of electrical stimulation trains of 1000 symmetrical biphasic pulses (1 ms, 100 Hz). The duration of a train is of 10 s and the rest between trains is of 30 s. A WP NMES session includes 30 evoked contractions. The stimulation intensity is monitored online and adjusted to the highest tolerable by the subjects.During the stimulation, subjects are seated with the knee joint fixed a 60° angle. Three self-adhesive electrodes are placed over the right thigh. The positive electrodes, measuring 25 cm² (5 x 5 cm), are placed as close as possible to the motor point of the vastus lateralis and vastus medialis muscles. The negative electrode, measuring 50 cm² (10 x 5 cm), is placed 5-7 cm below the inguinal ligament. Electrical stimulations are delivered by a stimulator BioStim (Mazet Santé).
15750272|NCT04857710|Device|Conventional neuromuscular electrostimulation (CONV NMES)|"The CONV NMES program consists of electrical stimulation trains of 500 symmetrical biphasic pulses (0.2 ms, 50 Hz). The duration of a train is of 10 s and the rest between trains is of 30 s (duty cycle: 1/3). A WP NMES session includes 30 evoked contractions. The stimulation intensity is monitored online and adjusted to the highest tolerable by the subjects.
~During the stimulation, subjects are seated with the knee joint fixed a 60° angle. Three self-adhesive electrodes are placed over the right thigh. The positive electrodes, measuring 25 cm² (5 x 5 cm), are placed as close as possible to the motor point of the vastus lateralis and vastus medialis muscles. The negative electrode, measuring 50 cm² (10 x 5 cm), is placed 5-7 cm below the inguinal ligament. Electrical stimulations are delivered by a stimulator BioStim (Mazet Santé)."
15750273|NCT04857710|Device|Control (CONT) modality|Control (CONT) modality is used as a reference and is representative of a sedentary behaviour regularly observed in our populations.
15750274|NCT04857697|Procedure|Biopsy|Undergo biopsy
15750275|NCT04857697|Procedure|Biospecimen Collection|Undergo collection of blood, stool, and tissue samples
15750276|NCT04857697|Dietary Supplement|Probiotic|Given PO
15750277|NCT04857697|Procedure|Therapeutic Conventional Surgery|Undergo standard of care surgery
15750278|NCT04857684|Drug|Atezolizumab|Intravenous Infusion
15750279|NCT04857684|Drug|Bevacizumab|Intravenous Infusion
15750280|NCT04857684|Radiation|Stereotactic Beam Radiation Therapy (SBRT)|External beam radiation
15750281|NCT04857671|Drug|Botulinum Toxin Type A in saline water|"150 Allergan units Botulinum toxin A in a total of 3 ml sodium chloride (NaCl) 0,9% Braun.
~5 IU of Botox per injection point (0,1ml); in total 150 IU per 30 injections points."
15750282|NCT04857671|Drug|Isotone saline water|3ml Na Cl (sodium chloride) 0,9% Braun. 0,1ml per injection point in total 30 injections points
15750283|NCT04857658|Procedure|extraction orthodontic treatment plan|patients will be referred for extraction of the upper and lower first premolars then orthodontic treatment will follow.
15750284|NCT04857645|Drug|ASTX727|Eligible patient started ASTX727 between 40 and 130 days after allogenic stem cell transplantation
15750285|NCT04857645|Other|Donor Lymphocyte Infusions|In absence of previous grade 2-4 or chronic graft-versus-host disease (GVHD), DLI will be administered at increasing doses the first day of ASTX727 cycles
15750287|NCT04857619|Other|None (Observational study)|The data on different types of treatment received by the patients, socio-demographics, and clinico-pathological characteristics and healthcare resource utilisation will be extracted from patients' medical records (both alive and deceased).
15750288|NCT04857606|Drug|AMG 609|Single dose of AMG 609 administered as a subcutaneous injection.
15750289|NCT04857606|Drug|Placebo|Single dose of placebo administered as a solution for injection.
15750290|NCT04857593|Behavioral|Melodies for Mums|"Classes start with a chat between mothers and the artist. The singing session will include welcome songs, introducing the babies and mothers to one another, and then involve a range of singing and music activities. These will include learning songs from around the world, ranging from short vocal exercises that use motherese style noises and sound effects (including sound baths where the mothers sang a sustained note providing a relaxation technique), to simple lullabies that can be picked up very quickly and sung in basic harmonies or rounds, to longer or more complex songs that will be learnt gradually over the weeks. Instruments such as guitar and ukulele will also be used by the artist for a small number of songs. Mothers will also work to write some of their own songs over the weeks, developing lyrics together about their babies or experiences of motherhood and creating simple melodies. Classes will be led by workshop leaders trained by Breathe, with support of assistants."
15750291|NCT04857580|Device|CTS Device|Coronary cryotherapy is delivered locally on eligible lesions randomized to the treatment using the CTS System.
15750350|NCT04857099|Other|Data extraction from medical files|Data extraction from medical files
15750351|NCT04857073|Other|Glucose Monitoring|Glucose monitoring consists of finger stick fasting and 2 hours post prandial
15750292|NCT04857567|Behavioral|TSC program (Three Self-Commitment program)|"Self-Competence program
~- A program for residents who experience exhaustion due to the spirit of volunteerism and high expectations of therapeutic competency in the case of experiencing a decrease in personal achievement.
~Self-Care program
~- A program to help individuals who experience dehumanization due to emotional suppression and develop exhaustion in the process of suppressing emotions to protect themselves from excessive feelings of compassion experienced in the medical scene
~Self-Compassion program - A program for residents who experience emotional burnout and exhaustion due to pressure of failure because medical professionals should be competent and excellent"
15750293|NCT04857554|Other|Glucose as reference food|Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g glucose diluted in 250ml water, tested twice, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.
15750294|NCT04857554|Other|White bread as reference food|Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from white bread along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.
15750295|NCT04857554|Other|White bread with apricot jam|Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from white bread together with apricot jam along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.
15750296|NCT04857554|Other|Cereal bar with cranberries|Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from a cereal bar with cranberries along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.
15750297|NCT04857554|Other|Cocoa drink|Twelve healthy, normal weight subjects (male: 6,female: 6) after 10-14 hr fast, consumed 25g available carbohydrates from cocoa powder mixed with 500ml fat-free milk, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45,60, 90 and 120min.
15750298|NCT04857528|Radiation|Radiation Treatment With or Without Chemotherapy|Standard care radiation treatment.
15750299|NCT04857528|Other|Blood Sample Collection|Researchers will collect blood samples from participants before, during and after radiation treatment. Approximately 6 teaspoons of blood will be collected each time blood is drawn.
15750300|NCT04857528|Diagnostic Test|HPV Genotyping (HPV DNA Test)|A test used to detect the type of HPV DNA found in the participant's blood and tumor tissue samples.
15750301|NCT04857528|Diagnostic Test|Testing Archival Tumor Tissue|Tumor tissue will be tested in a lab for all cervical cancer participants and some participants with anal cancer as assessed by the lead study doctor. This tumor tissue sample will be from a previous biopsy that the participant received before the study per standard care; no new biopsy will be required for this study.
15750302|NCT04857528|Other|Physical Exam|A physical exam will be given 12 months after radiation treatment. This physical exam may also include an anoscopy (a procedure to examine the anus using a device inserted into the anus) or sigmoidoscopy (a procedure that looks at the rectum and lower part of the colon using a device inserted into the anus).
15750303|NCT04857528|Diagnostic Test|Positron Emission Tomography Scan (PET Scan)/ Computed Tomography Scan (CT Scan)|Tests that use computers and/or rotating x-rays to scan/create images of the body.
15750304|NCT04857515|Device|Clickotine®|Clickotine is a DTx that contains behavior modification techniques that include controlled breathing, social engagement, personalized messaging, medication access and adherence, digital diversions, and financial incentives.
15750305|NCT04857502|Drug|99mTc-based PSMA Imaging and Surgery Agent|Given via IV injection
15750306|NCT04857502|Procedure|Computed Tomography|Undergo SPECT/CT
15750307|NCT04857502|Procedure|Single Photon Emission Computed Tomography|Undergo SPECT/CT
15750308|NCT04857476|Diagnostic Test|Ultrasound scan|"Psoriasis epidemiology screening tool (PEST) score for completion Brief questionnaire about current psoriasis symptoms, current treatment and if any features associated with psoriatic arthritis.
~One-off musculo-skeletal ultrasound Questionnaire at 2 years"
15750309|NCT04857463|Other|Nutritional supplement drink|At the intervention period (0th to 12th week of the experiment), In addition to nutrition and health education, subjects were provided with 2 bottles of commercially available oral nutritional supplements (Meiji Mei Balance, Meiji Co., Ltd., Tokyo, Japan) every day, between lunch and dinner and before bedtime.
15750310|NCT04857463|Other|Nutritional education|At the intervention period (0th to 12th week of the experiment) , subjects will be given regular nutrition education by a qualified clinical dietitian to ensure the effectiveness of nutrition education, in order for the nutrition education group to benefit from participating in this trial, the subjects will also be provided with the same nutritional products after the trial
15750311|NCT04857450|Drug|Etomidate|Received Etomidate 0.2 mg/kg IV over 30 seconds, followed by Etomidate 0.05 mg/kg IV and repeated when needed.
15750312|NCT04857450|Drug|Ketamine Hydrochloride|Received Ketamine 0.5 mg/kg IV over 30 seconds then Etomidate 0.1 mg/kg IV over 30 seconds, followed by 0.05 mg/kg IV and repeated when needed.
15750313|NCT04857437|Drug|PF-07202954 Repeat Dose|10, 30, 100, 300, 600, 1200 milligrams (mg)
15750314|NCT04857437|Drug|PF-07202954 Single Dose|10, 30, 100, 300, 600, 900, 1200 milligrams (mg)
15750315|NCT04857437|Drug|Placebo|Matching Placebo
15750316|NCT04857411|Behavioral|Peers LEAD plus HLWD|Combined Peers LEAD and Healthy Living with Diabetes is a culturally-appropriate program to increase medication adherence
15750317|NCT04857398|Drug|insulin icodec|"Participants will get insulin icodec once a week for 6 weeks. The medicine will be injected under the skin.
~The study will last for 15 to 22 weeks."
15750318|NCT04857385|Device|Radial artery hemostasis|Each of the devices will be assessed for radial artery hemostasis.
15750320|NCT04857359|Drug|Dipraglurant|Oral 50mg and 100mg tablet
15750321|NCT04857359|Drug|Placebo|Oral matching placebo tablet
15750352|NCT04857060|Behavioral|ACP Educator led, video assisted discussion|For hospitalized patients identified by a defined EHR algorithm, an ACP Educator will meet with the patient in the hospital to provide primary palliative care services such as goals-of-care conversations and clinician communication by leveraging certified video decision aids.
15750322|NCT04857346|Drug|Indocyanine green|Single application of PDT will be performed. A diode laser (HELBO®TheraLite - Bredent Medical, Germany) with 670 nm wavelength, power of 150 mW, fluency of 22 J/cm2 and density of 1.1 W/cm2 will be used in this study. Indocyanine-green photosensitizer (Sigm Aldrich, USA) with 0.005% concentration will be used as a photosensitizer which will be applied inside the periodontal pockets in a depth of 3 mm with the help of a blunt needle for 10 s. Laser irradiation will be performed for 60 s using a flexible tip. Laser irradiation will be performed at 2 points each on buccal and lingual with the tip stabilized perpendicular to the gingival tissues.
15750323|NCT04857333|Diagnostic Test|CT scan|For patients with low-risk pulmonary nodules, follow-up CT scan is recommended
15750324|NCT04857333|Drug|Antibiotics|For pulmonary nodules with features of infectious disease, antibiotics is recommended
15750325|NCT04857333|Procedure|Surgical Resection|For persistent high-risk pulmonary nodules, surgical resection is recommended
15750326|NCT04857320|Combination Product|Human insulin|Human Insulin from recombinant source delivered in a solution capable of enabling transdermal delivery formulated at 100 IU/mL of delivery vehicle.
15750328|NCT04857294|Procedure|TMJ unilateral discectomy|All patients underwent general anesthesia with nasotracheal intubation, managed in most cases with intravenous anesthesia protocol, usually with remifentanil infusion. Intraoperative steroids, usually dexamethasone, were administered primarily to minimize postoperative swelling. A classic preauricular incision or a root of helix inter tragus notch incision (RHITNI) was used in most cases, as previously described. No bandage or special care was performed after the surgery. No air washing restrictions were recommended.
15750329|NCT04857281|Device|nVNS (gammaCore)|The treatment will be self-administered using nVNS and will be applied for 4 weeks; a member of the study will provide the proper training on the correct use of nVNS. The patient will be instructed to use the nVNS in place of the rescue medications. When the nauseas gets bad enough that they feel to use a rescue medication they will first use the device on one side of the neck for two 2-minute stimulations and wait fifteen minutes to check if the stimulation works. If this does not help either, they will stimulate with an additional 2 stimulations and wait for another fifteen minutes. If there is no improvement rescue medication will be used. nVNS can be used up to, but no more than, 8 times a day.
15750330|NCT04857268|Device|wearable continuous ECG monitoring patch, ATP-C120|"ATP-C120 is a novel, single-lead ECG monitoring device which can continuously monitor the ECG signal as long as 14 days (11 days if the device is connected to the smartphone via Bluetooth) when attached to skin adjacent to the heart of patients. It weighs about 8.3 g, with a size of 84 × 39 × 8.3 mm.
~When the device is attached to the patient, several predefined methods were utilized to prevent the occurrence of noise or signal loss. First, the skin was cleansed and disinfected using a 70% ethanol solution. Skin hair was removed if needed. Then the protection film was removed from the patient-side surface of the device. The device is placed at the left 3rd intercostal space 45 degrees tilted toward the inside."
15750331|NCT04857255|Behavioral|Technology assisted language intervention|speech language therapy that has integrated technology delivered through specific software on an iPad
15750332|NCT04857255|Behavioral|Treatment as usual|No change will occur to the current ongoing speech-language therapy being delivered.
15750333|NCT04857242|Diagnostic Test|Apnea test, alveolar recruitment|Alveolar recruitment following the phase of apnea testing
15750334|NCT04857229|Device|Histolog Scanner|Confocal Microscope
15750335|NCT04857216|Device|Perfusion Index|perfusion index in the prediction of peripheral block success was previously reported for infraclavicular brachial plexus block, axillary brachial plexus block, interscalene brachial plexus block, and supraclavicular brachial plexus in adult patients
15750336|NCT04857203|Diagnostic Test|Vitamin D|Vitamin D levels will be measured for the patients undergoing neoadjuvant therapy in patients with locally advanced rectal cancer
15750337|NCT04857190|Device|Parker Flex-it Directional Stylet|Parker Flex-it Directional Stylet
15750338|NCT04857190|Device|Conventional Malleable Stylet|Conventional Malleable Stylet
15750339|NCT04857177|Drug|CKD-701|CKD-701 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every one month during the loading phase, and intervals of one month based on criteria during the PRN phase.
15750340|NCT04857177|Drug|Lucentis®|Lucentis® (ranibizumab) 0.5mg via intravitreal injection every one month during the loading phase, and intervals of one month based on criteria during the PRN phase.
15750341|NCT04857164|Drug|Pembrolizumab combined with Chemotherapy|Pembrolizumab (formerly lambrolizumab, brand name Keytruda) is a humanized antibody used in cancer Chemotherapy regimen is selected by the investigator immunotherapy. This includes to treat melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, and stomach cancer.
15750343|NCT04857138|Drug|RO7300490|Participants will receive RO7300490, as described in the Arm Descriptions.
15750344|NCT04857138|Drug|Atezolizumab|Participants will receive Atezolizumab, as described in the Arm Descriptions.
15750345|NCT04857125|Other|Patient interventions|"The multicomponent intervention consists of several elements regarding avoidance of specific pre-medications and optimising the patients condition before surgery (reducing fasting and fluid-fasting time).
~Per-operative focus on using bispectral index (BIS) guided anaesthesia, Total intravenous anaesthesia (TIVA) as first choice, pain-and PONV (postoperative nausea and vomiting) prophylaxis and treatment.
~Postoperative focus on: Reducing indwelling catheters, Fluid (p.o. or IV), Nutrition, Mobilisation, Sleep, Non-pharmacological interventions (Shielding, involving of relatives, orientation, optimizing of senses)"
15750346|NCT04857125|Other|Staff education|Staff will be educated for at least 1-2 hours. Anaesthesiologist and nurse anaesthetists will receive a brush up on the use of bispectral index (BIS) and the intervention elements that are implemented and monitored. Staff in the PACU, as well as staff in the surgery wards, will be educated in postoperative delirium, learning to identify symptoms of delirium and how to use the screening tool CAM.
15750347|NCT04857112|Drug|Low Dose MT-1303|MT-1303 loading dose of 0.4 mg once daily (QD) (Day 1-14) then maintenance dose of 0.2 mg QD (Day 15-85)
15750348|NCT04857112|Drug|High Dose MT-1303|MT-1303 loading dose of 0.8 mg QD (Day 1-14) then maintenance dose of 0.4 mg QD (Day 15-85)
15750349|NCT04857112|Drug|Placebo|Matching placebo, QD (Day 1-85)
15750354|NCT04857047|Drug|BR9003A 1mg|After fasting for at least 10 hours from 10:00 p.m. the previous day, one BR9003A tablet will be administered orally with 150mL of water around 8:30 a.m. after starting breakfast 30 minutes before the scheduled time of administration and finishing it. Another BR9003A tablet will be administered orally with water 150mL around 20:30 after dinner between 18-19:00.
15750355|NCT04857034|Drug|BMS-986165|Specified dose on specified days
15750356|NCT04857034|Drug|Placebo|Specified dose on specified days
15750357|NCT04857021|Dietary Supplement|GABA|oral administration of GABA capsule once daily before sleep
15750358|NCT04857021|Dietary Supplement|Placebo|oral administration of placebo capsule once daily before sleep
15750359|NCT04857008|Device|BNT001|BNT001 is a commercially-available, prescription-only, software / medical device in the form of a digital application (digital app) for use on the participant's mobile device which delivers 10-sessions on cognitive behavioral therapy for cancer patients.
15750360|NCT04856995|Other|exposure to surgical smoke during surgery|No intervention was made. During the surgery, complaints and throat cultures were taken before and after exposure to surgical smoke. Simultaneously, 45 air samples are taken in the operating room before, during and after the operation.
15750361|NCT04856982|Drug|BIIB067 (Tofersen)|Administered as specified in the treatment arm
15750362|NCT04856982|Drug|Placebo|Administered as specified in the treatment arm
15750363|NCT04856969|Drug|Olmesartan|First stage: ATB-1011 for 5days, repeated administration, Second stage: ATB-1012 + ATB-1011 for 5days, repeated administration
15750364|NCT04856969|Drug|Dapagliflozin|First stage: ATB-1012 for 5days, repeated administration, Second stage: ATB-1012 + ATB-1011 for 5days, repeated administration
15750365|NCT04856956|Other|Diagnostic decision support software|Comparing use of decision support group (intervention group) to use only of common literature (control group) among pediatric trainees diagnosing patients with possible rheumatologic disorder
15750366|NCT04856943|Procedure|Smartconsent application|Patients asigned to smartconsent group will sign informed consent through a Tablet.
15750367|NCT04856943|Other|Control group|Patient asigned to control group will sing the informed consent in papel, as it is performed in clinical practice
15750368|NCT04856930|Biological|Imsidolimab|Humanized Monoclonal Antibody
15750369|NCT04856930|Biological|Placebo Solution|Placebo
15750370|NCT04856917|Drug|Imsidolimab|Humanized Monoclonal Antibody
15750371|NCT04856917|Biological|Placebo|Placebo
15750372|NCT04856904|Drug|Trifarotene Cream|Participants will apply a thin a layer of trifarotene (CD5789) 50 mcg/g cream to the face once daily, in the evening for 24 weeks
15750373|NCT04856904|Drug|Trifarotene Vehicle Cream|Participants will apply a thin a layer of trifarotene vehicle cream to the face once daily, in the evening for 24 weeks
15750374|NCT04856891|Drug|AK002|Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1(IgG1) monoclonal antibody directed against Siglec-8.
15750375|NCT04856891|Other|Placebo|Placebo
15750376|NCT04856878|Drug|Vancomycin|The investigational drug vancomycin is administered intravenously through a newly inserted peripheral or central venous catheter directly after removal of the 'old' catheters. The investigational drug is administered with a volume of 500ml normal saline (NaCl 0.9%) with a rate of maximal 1g per hour.
15750377|NCT04856865|Biological|ADP101 vs Placebo Dose Regimen A|Active powder formulation at various volumes. Placebo powder formulation at various volumes.
15750378|NCT04856865|Biological|ADP101 vs Placebo Dose Regimen B|Active powder formulation at various volumes. Placebo powder formulation at various volumes.
15750379|NCT04856852|Other|Iodine-125+Chemotherapy|Iodine-125: Iodine-125 if necessary, 0.6-0.8mCi, PD:120-150Gy Temozolomide: 75 mg per square meter of body-surface area per day, 7 days per week,42 days.
15750380|NCT04856852|Other|Surgical resection+Radiochemotherapy|"Surgical resection: Maximal surgical resection, including gross total resection, subtotal resection, and partial resection.
~Radiation: total 60 Gy, 2 Gy per daily fraction (Monday to Friday) for 6 weeks. Temozolomide: 75 mg per square meter of body-surface area per day, 7 days per week,42 days."
15750381|NCT04856839|Diagnostic Test|high throughput sequencing and electromyography|Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics
15750383|NCT04856813|Other|Manual therapy active|massage or ischemic compression with active contraction, tha will be isometric or concentric.
15750384|NCT04856813|Other|Manual therapy|massage or isquemic compression without contraction
15750385|NCT04856800|Dietary Supplement|Whey|20 g protein of whey protein isolate WPI (Lacprodan® ISO.Water. from Arla Foods Ingredients)
15750386|NCT04856800|Dietary Supplement|Placebo|The placebo contains <1 kcal and 0 g protein
15750387|NCT04856787|Drug|SHR-1701、 BP102 、XELOX|"Phase 2：Single Group
~Drug:SHR-1701 30mg/kg，IV ,every 3 week
~Drug：BP102 7.5mg/kg，IV,every 3 week
~Drug: Oxaliplatin 130mg/m2 ，IV,every 3 week
~Drug:Capecitabine The total daily dose was 2000mg/m2, OR，Each cycle was administered for 2 consecutive weeks, followed by a week of rest, with a treatment cycle every 21 days"
15750388|NCT04856787|Drug|SHR-1701、 BP102 、XELOX|"Phase 3：Randomized
~Drug:SHR-1701 30mg/kg，IV ,every 3 week
~Drug：BP102 7.5mg/kg，IV,every 3 week
~Drug: Oxaliplatin 130mg/m2 ，IV,every 3 week
~Drug:Capecitabine The total daily dose was 2000mg/m2, OR，Each cycle was administered for 2 consecutive weeks, followed by a week of rest, with a treatment cycle every 21 days"
15750389|NCT04856787|Drug|placebo、 BP102、 XELOX|"Phase 3：Randomized
~Drug:Placebo 30mg/kg，IV ,every 3 week
~Drug：BP102 7.5mg/kg，IV,every 3 week
~Drug: Oxaliplatin 130mg/m2 ，IV,every 3 week
~Drug:Capecitabine The total daily dose was 2000mg/m2, OR，Each cycle was administered for 2 consecutive weeks, followed by a week of rest, with a treatment cycle every 21 days"
15750390|NCT04856774|Drug|SHR-1701；BP102|"Drug: SHR-1701 IV infusion
~Drug: BP102 IV infusion
~Phase Ib: SHR-1701 30mg/kg + BP102 15mg/kg Q3w as starting dose, until recommended phase 2 dose is determined."
15750391|NCT04856761|Drug|S-1|S-1 was administered at a dose of 80-120 mg/day on 14 days of a tri-weekly cycle for 8 cycles.
15750392|NCT04856761|Drug|Capecitabine|Capecitabine was administered at a dose of 1250 mg/m² bid on 14 days of a tri-weekly cycle for 8 cycles.
15750496|NCT04855981|Other|aerobic exercise|the subjects will receive aerobic exercises+ magnesium (Mg) (250 g) and vitamin B6 supplementation
15750393|NCT04856735|Other|Intraperİtoneal local anaesthesİc İn cesarean sectİon|After the birth of the newborn and placenta, the uterus is closed and the blood accumulated in the pelvis is carefully wiped with surgical towels, after hemostasis is fully achieved, a total of 20 ml solution containing 10 cc of 0.5% bupivacaine +10 cc 2% lidocaine and 2 injectors containing 20ml saline and the 20ml solution were given to the surgeon area.
15750394|NCT04856735|Other|Local wound infiltrasyon|A solution containing 20 ml of saline was added to all four quadrants of the uterus in 5 ml volume and 20 ml solution containing lidocaine and bupivacaine were subcutaneously in the form of LWI before the skin was closed
15750395|NCT04856735|Other|Control group|One of the two sterile injectors containing 20 ml of saline was applied to the uterine peritoneal region and the other was applied to the incision area as a local subcutaneous wound infiltration.
15750396|NCT04856722|Procedure|mini-PNL|PCNL using miniature nephroscope. The procedure will be performed under general or regional anaesthesia under fluoroscopy guidance.
15750397|NCT04856722|Procedure|RIRS|RIRS using flexible ureteroscope. The procedure will be performed under general or regional anaesthesia under fluoroscopy guidance. Holmium Laser lithotripter will be used for stone fragmentation.
15750398|NCT04856722|Procedure|SWL|SWL using Dornier SII lithotripter. the procedure will be performed under sedoanalgesia, and fluoroscopy will be used for stone localization; for a maximum of 3 SWL session.
15750399|NCT04856709|Procedure|Abdominal Pectopexy|Pectopexy is a new technique for apical repair in which lateral parts of the iliopectineal ligament are used for cuff or cervix suspension.
15750400|NCT04856709|Procedure|Abdominal Sacral Hysteropexy|Abdominal sacrocolpopexy is a procedure that uses a mesh material to support the top of the vagina to treat pelvic prolapse.
15750401|NCT04856696|Diagnostic Test|PGT-A|trophectoderm biopsy in blastocyst stage for euploidy testing using next generation sequencing platform
15750402|NCT04856696|Diagnostic Test|non-invasive PGT-A|cell-free DNA collected from spent culture media for euploidy testing using next generation sequencing platform
15750403|NCT04856670|Procedure|Cataract surgery|Cataract surgery- Manual or femtosecond laser assisted
15750405|NCT04856644|Drug|4-month rifapentine-based regimen|8 weeks of isoniazid, pyrazinamide, rifapentine, and moxifloxacin, followed by 9 weeks of isoniazid, rifapentine and moxifloxacin
15750406|NCT04856631|Drug|Toripalimab Injection|240mg once per 3 weeks
15750407|NCT04856631|Drug|Cetuximab Solution for infusion|First infusion 400mg/m2，Subsequent infusions 250mg/m2。once per week
15750408|NCT04856618|Biological|Massive Transfusion of Allogeneic Blood|Massive Transfusion of Allogeneic Blood, > pRBCs
15750409|NCT04856605|Procedure|surgery|regular surgery
15750410|NCT04856592|Device|Boston Scientific Vici® Venous Stent System|The Vici Venous Stent System comprises two components: the implantable endoprosthesis and its stent delivery system, a 9F over-the-wire system available in a 100cm length and compatible with 0.035in (0.89mm) guidewires
15750411|NCT04856592|Device|Boston Scientific Opticross 35 Peripheral Imaging Catheter (OC35 catheter)|The Opticross 35 catheter is designed for use with a guidewire measuring ≤0.035 in (0.89 mm) in diameter and an introducer sheath of 8F (2.67 mm) or larger. The working length of OC35 catheter is 105 cm.
15750412|NCT04856579|Procedure|Varicocelectomy|Subinguinal varicocelectomy under general anesthesia and complete aseptic condition
15750418|NCT04856553|Other|Acute effects of handgrip exercise|The participants will be randomized into three sessions, handgrip exercise in the morning, handgrip exercise in the afternoon, and control performed in the morning to analyze the acute effects of handgrip exercise on blood pressure and vascular function at different times of the day. After the morning sessions, ambulatory blood pressure will also be measured for 24 hours.
15750419|NCT04856527|Behavioral|Physical therapist support|Participants will receive physical therapist support to reduce postural sway variability while completing an upper limb precision aiming task in virtual reality.
15750420|NCT04856514|Behavioral|PEERS|16 week telehealth intervention; parallel teen and parent/caregiver groups; 90 minutes each week.
15750421|NCT04856501|Behavioral|PALS intervention condition|The Play and Learning Strategies (PALS) intervention provides parents with behaviors that, collectively, are known as a responsive parenting style. Four constructs make up this responsive parenting style: 1) contingent responsiveness, (responses are conditionally linked to the child's signals) 2) warm sensitivity (high levels of affection and understanding of child states), 3) maintaining vs. redirecting attention, and 4) verbal scaffolding (providing child appropriate language supports). Parents assigned to this intervention will be paired with a coach who will guide them through the program over the course of 9 weekly sessions. The intervention (ePALS) will be implemented via an internet adaptation through the Children's Learning Institute's ENGAGE platform. However, ePALS could easily be adapted for other platforms and accessed with any web-enabled device.
15750422|NCT04856501|Behavioral|Control condition|Families assigned to the control condition will be provided with a website with information corresponding to milestones of toddler development. Control families will be asked to review that week's materials before the each of the 9 weekly coach calls. The active control condition serves three important purposes: 1) Maintains an active line of communication and accurate contact records for Post-test 1 and Post-test 2 session scheduling; 2) Masks participant's awareness of intervention vs. control assignment; and 3) Approximates communication with intervention staff such that results showing ePALS effects are attributable to intervention rather than regular communication with an interventionist.
15750423|NCT04856488|Drug|Iodine-Potassium Iodide 5%-10% Oral and Topical Solution|Iodine Potassium Iodide 5% oral solution, administered 3 times per day for 10 days
15750497|NCT04855981|Other|supplementation|the subjects will receive magnesium (Mg) (250 g) and vitamin B6 supplementation
15750424|NCT04856475|Drug|Neratinib|"As per investigator's choice, eligible subjects in all cohort will receive:
~Neratinib, administered continuously at a dose of 240 mg orally once a day in combination with:
~Capecitabine, administered continuously at a dose of 750 mg/m2, orally, twice a day (=daily dose of 1500 mg/m2) from D1 toD14 (21 days cycle) (preferred option) or
~Vinorelbine, I.V. 25 mg/m2 on D1 and D8 (21 days cycle) or
~Paclitaxel, I.V. 80 mg/m2 on D1, D8, and D15 (21 days cycle) Important note: The possibility to combine trastuzumab, loading dose 8 mg/kg IV followed by 6 mg/kg Q3W IV or SC 600 mg Q3W, to one of these above treatments is left at investigator's discretion OR
~Neratinib, administered continuously at a dose of 160 mg, orally, once a day in combination with:
~T-DM1, I.V. 3.6mg/m2 on D1 (21 days cycle) (preferred option)"
15750425|NCT04856462|Behavioral|Education Support|Structured education is provided each week to family caregivers over the course of 12 weeks along with facilitated telephone group meetings.
15750426|NCT04856462|Behavioral|Phone Call|Participants will participate in an unstructored support group phone call
15750427|NCT04856449|Behavioral|Dialectical Behavioral Therapy Skills Training|DBT skills training consists of a 6 months training in mindfulness, emotion regulation, interpersonal effectiveness and distress tolerance.
15750428|NCT04856449|Behavioral|EMDR|EMDR sessions will be conducted to reprocess trauma-related memories.
15750429|NCT04856436|Drug|Benzodiazepine|Exposure to benzodiazepine during early pregnancy
15750430|NCT04856423|Diagnostic Test|The us-qFIT and colonoscopy with pathological examination|Detect fecal hemoglobin concentration by us-qFIT before colonoscopy, detect colon lesions using colonoscopy and pathological examination.
15750431|NCT04856410|Other|Spaceflight|Exposure to the spaceflight environment on the International Space Station for 2, 6, or 12 months.
15750432|NCT04856410|Other|Controls|No intervention
15750433|NCT04856397|Drug|Intravitreal Implant in Applicator|Dexamethasone intravitreal implant
15750434|NCT04856397|Drug|Eylea|anti-VEGF medication
15750435|NCT04856384|Other|synchronisation abilities|The study contains 1 descriptive and 3 experimental sessions. In the descriptive session, participant's clinical motor and cognitive functions are collected. In the first experimental session, participant's beat perception and synchronisation abilities is examined within a finger tapping paradigm. In the following experimental sessions participants synchronsiation abilities is examined during walking paradigms, to music and metronomes, with period and phase auditory manipulations
15750436|NCT04856371|Drug|CYH33|Participants will receive oral CYH33 once daily on Days 1-28 of each 28-day cycle.
15750437|NCT04856371|Drug|Fulvestrant|Participants will receive fulvestrant 500 mg, administered intramuscularly on Days 1, 15 on Cycle 1 (28-day cycle) and Day 1 at each 28-day cycle thereafter.
15750438|NCT04856371|Drug|Letrozole|Participants will receive oral letrozole once daily continuous on Day 1-28 of each cycle.
15750439|NCT04856371|Drug|Palbociclib|Participants will receive palbociclib once daily continuous on Day 1-21 of each 28-day cycle.
15750440|NCT04856358|Drug|GLPG3121|GLPG3121 modified-release tablet
15750441|NCT04856358|Drug|Placebo|Matching placebo
15750442|NCT04856345|Other|Walking with music with synchronisation|Walking with music than one can synch to
15750443|NCT04856345|Other|Walking with music without synchronisation|Walking with music than one cannot synch to
15750444|NCT04856345|Other|walking without music|Walking without music
15750445|NCT04856332|Other|Telepresence robot installed at child's home during parent's hospitalisation|Telepresence robot installed at child's home during parent's hospitalisation in long term protective isolation for maintaining parent-child ink (only children aged 15 years or less are concerned)
15750446|NCT04856319|Procedure|Dental implant placement|Insertion of not more than two dental implants at the same area
15750447|NCT04856319|Drug|Antibiotic prophylaxis|Per-os 2g amoxicillin+clavulanic acid will be administered one hour prior to the surgery
15750448|NCT04856319|Other|Placebo|Per-os placebo (inert polysaccharide) will be administered one hour prior to the surgery
15750449|NCT04856306|Other|Groups 1 and 2 myomectomy and uterine artery embolization, respectively, are surgical/procedure|See previous descriptions
15750450|NCT04856306|Drug|Elagolix Oral Product|See group 3 description
15750451|NCT04856293|Drug|Crizotinib|A single 250 mg crizotinib dose of the FC formulation
15750452|NCT04856293|Drug|Crizotinib|A single 250 mg crizotinib dose of the encapsulated microsphere (eMS) formulation administered by sprinkling the contents into a dry glass vial
15750453|NCT04856293|Drug|Crizotinib|A single 250 mg crizotinib dose of the single 250 mg crizotinib dose of the encapsulated microsphere (eMS) formulation (administered as intact capsules) . The intact capsules will be swallowed whole.
15750454|NCT04856280|Behavioral|Kinesiological taping|In KT Group, 6 sessions of KT were applied, starting on the 14th day of the menstrual cycle and 2 times a week for 3 weeks until the cycle ended.
15750455|NCT04856280|Behavioral|Aerobic exercise|In the AE group, walking and climbing stairs were given during the menstrual cycle, 3 days a week, 45 minutes.
15750456|NCT04856267|Device|"LINQ device - implantable cardiac monitor - referred to in the application as implantable loop recorder or ILR)"|Implantation of an implantable cardiac monitor device (brand name LINQ device, Medtronic) will be performed under local anaesthetic using an aseptic sterile technique. They will undergo frequent follow-up and monitoring for arrhythmias through remote monitoring of the device
15750457|NCT04856254|Procedure|Trial of labor after cesarean section|The pregnant females with history of previous cesarean section will be classified according to clinical and ultrasound score as patient suitable to undergo trial of labor after CS [TOLAC]or not suitable for [TOLAC] so undergo from the beginning to elective repeated cesarean section.
15750458|NCT04856241|Other|Coaching|Physiotherapists (trained by the research team) train the coaches to deliver Prep-to-Play. The Physiotherapists will also provide face-to-face one-to-one support to each coach at their team's training session (two visits), with all their players.
15750459|NCT04856241|Other|Peer support|Coaches shed. Coaches provide each other with support and ideas. Strategies to overcome barriers and motivate players.
15750460|NCT04856241|Other|Educational materials|Prep-to-Play program resources are available online for coaches and players to view
15750461|NCT04856228|Diagnostic Test|diagnostic posterior interosseous nerve lidocaine injection|ultrasound guided posterior interosseous nerve and lateral epicondyle 1 ml 2% lidocaine injection
15750835|NCT04853212|Procedure|Biopsy|Biopsy during recto-coloscopy
15750462|NCT04856215|Drug|90-Yttrium-labelled anti-CD66 monoclonal antibody|"The Investigational Medicinal Product (IMP) consist of 1) 111Indium- and 2) 90Yttrium-labelled anti-CD66 (BW250/183) monoclonal antibody.
~The anti-CD66 is a murine IgG1 monoclonal antibody originally developed as an in vivo leucocyte and bone marrow imaging agent (Boßlet 1985, Thomsen 1991). BW 250/183 anti-CD66 is a murine IgG1 kappa monoclonal antibody, originally produced as an anti-CEA antibody.
~The batch of antibodies required for treatment will be radiolabelled by Royal Free Hospital radiology team with Indium 111 and Y90 for patient."
15750463|NCT04856202|Behavioral|Advance Care Planning interview|The facilitator will clarify the patients' preferences, asking specific questions regarding personal goals, including religious and cultural beliefs. The facilitator will discuss life supporting treatments that might be applicable to the patient and encourage the patient to weigh up personal benefits and burdens. Treatments may include: invasive therapy (such as chemotherapy or dialysis), hospitalization, resuscitation, ventilation, artificial nutrition or hydration and administration of antibiotics. The patient will also be encouraged to identify specific situations that are likely to improve or diminish his or her quality of life. The facilitator will assist the patient in documenting their wishes, including the assignment of a health care proxy.
15750464|NCT04856189|Biological|Pembrolizumab|Given IV
15750465|NCT04856189|Drug|Selinexor|Given PO
15750466|NCT04856176|Drug|Granulocyte-Macrophage Colony-Stimulating Factor|250ug/m2
15750467|NCT04856176|Drug|Pembrolizumab|200mg every 3 weeks
15750468|NCT04856176|Drug|pemetrexed|500mg/m2
15750469|NCT04856176|Drug|Paclitaxel|200mg/m2
15750470|NCT04856176|Drug|Carboplatin|AUC 5/6
15750471|NCT04856163|Behavioral|Telelactation support|Participants will get unlimited access (through 24 weeks postpartum) to video calls with lactation consultants who are available 24/7. Participants can use the service as demanded.
15750472|NCT04856150|Drug|Q-1802|Q-1802 will be administered intravenously.
15750473|NCT04856137|Drug|Rituximab Paclitaxel Ruxolitinib|Rituximab 375mg/m2 on D1 of each cycle Paclitaxel 200mg/m2 on D1 of each cycle Ruxolitinib continuously given (D1-21)
15750474|NCT04856124|Drug|Intranasal esketamine|Subjects with a clinically meaningful response to IV racemic ketamine were switched to IN esketamine
15750475|NCT04856111|Drug|Pirfenidone|Same as arm description
15750476|NCT04856111|Drug|Nintedanib|Same as arm description
15750477|NCT04856098|Drug|Indacaterol maleate and glycopyrronium bromide|Batch A Ultibro Breezhaler 85/43 μg 2 capsules
15750478|NCT04856098|Drug|Indacaterol maleate and glycopyrronium bromide|Batch A Ultibro Breezhaler 85/43 μg 1 capsule
15750479|NCT04856098|Drug|Indacaterol maleate and glycopyrronium bromide|Batch B Ultibro Breezhaler 85/43 μg 2 capsules
15750480|NCT04856098|Drug|Ultibro Breezhaler with oral charcoal|Activated charcoal suspension, granules 50 g / bottle
15750481|NCT04856085|Drug|VIR-2218|VIR-2218 given by subcutaneous injection
15750482|NCT04856085|Drug|VIR-3434|VIR-3434 given by subcutaneous injection
15750483|NCT04856072|Device|Deep Brain Stimulation|Personalized Deep Brain Stimulation of Fornix
15750484|NCT04856059|Diagnostic Test|Cardiac MRI, ECG/Holter and Blood Biomarkers|Cardiac MRI including T1/T2 mapping, ECG and blood biomarker evaluation will be performed at baseline and follow-up
15750485|NCT04856046|Procedure|Biospecimen Collection|Undergo collection of blood sample
15750486|NCT04856046|Other|Electronic Health Record Review|Review of medical records
15750487|NCT04856033|Behavioral|TM|Transcendental Meditation instruction, 12-sessions over 3-4 months with monthly follow-up
15750488|NCT04856033|Behavioral|PCT|Present Centered Therapy, 12-sessions over 3-4 months with monthly follow-up
15750489|NCT04856007|Drug|Dapagliflozin/metformin XR FDC 5/500 mg|In cohort 1, subjects will be randomized to receive co-administration of a single oral dose of a 5mg dapagliflozin tablet and a 500mg metformin XR tablets (Treatment A) followed by 7 to 14 days washout and then receive single FDC tablet consisting of 5mg dapagliflozin and 500mg metformin XR (Treatment B) on Day 1 in one treatment sequence. Or subjects will be randomized to be administered the Treatment B followed by 7 to 14 days washout and then received Treatment A on Day1 in the other treatment sequence.
15750490|NCT04856007|Drug|Dapagliflozin/metformin XR FDC 10/1000 mg|In cohort 2, subjects will be randomized to receive co-administration of a single oral dose of a 10mg dapagliflozin tablet and two 500mg metformin XR tablets (Treatment C) followed by 7 to 14 days washout and then receive single FDC tablet consisting of 10mg dapagliflozin and 1000mg metformin XR (Treatment D) on Day 1 in one treatment sequence. Or subjects will be randomized to be administered the Treatment D followed by 7 to 14 days washout and then received Treatment C on Day1 in the other treatment sequence.
15750491|NCT04856007|Drug|Dapagliflozin 5 mg + Metformin 500 mg XR|In cohort 1, subjects will be randomized to receive co-administration of a single oral dose of a 5mg dapagliflozin tablet and a 500mg metformin XR tablets (Treatment A) followed by 7 to 14 days washout and then receive single FDC tablet consisting of 5mg dapagliflozin and 500mg metformin XR (Treatment B) on Day 1 in one treatment sequence. Or subjects will be randomized to be administered the Treatment B followed by 7 to 14 days washout and then received Treatment A on Day1 in the other treatment sequence.
15750492|NCT04856007|Drug|Dapagliflozin 10 mg + Metformin 1000 mg XR|In cohort 2, subjects will be randomized to receive co-administration of a single oral dose of a 10mg dapagliflozin tablet and two 500mg metformin XR tablets (Treatment C) followed by 7 to 14 days washout and then receive single FDC tablet consisting of 10mg dapagliflozin and 1000mg metformin XR (Treatment D) on Day 1 in one treatment sequence. Or subjects will be randomized to be administered the Treatment D followed by 7 to 14 days washout and then received Treatment C on Day1 in the other treatment sequence.
15750493|NCT04855994|Procedure|paravertebral block|The investigators performed Paravertebral block to that patient group for postoperative analgesia
15750494|NCT04855994|Procedure|pectoral block|The investigators performed pectoral block to that patient group for postoperative analgesia
15750495|NCT04855981|Other|whole body vibration|All participants in the WBV group will perform the WBV training on a vibrating device (Confidence Vibration Plate Power Plus, China), which produces a lateral peak-to-peak oscillation. They will stand on the WBV platform with a 150° knee angle during the exposure minute. They started the training with three sets of 1 min separated by a 1-min resting period and vibration amplitude of 1 mm. They will add one set every session until they performed 10 sets of WBV. The frequency started at 20 Hz, which will be increased gradually by 2 Hz every 2 weeks +magnesium (Mg) (250 g) and vitamin B6 supplementation
15750498|NCT04855968|Other|In addition to standard post-op medication patient will have access to the head space meditation application.|Patients will receive access to head space meditation application in addition to standard pain medication post surgery.
15750499|NCT04855968|Other|Patients will take standard post-op pain medication|Standard post-op pain medication
15750500|NCT04855955|Drug|Adipose-Derived Mesenchymal Stem Cells|
15750501|NCT04855942|Device|Focused Extracorporeal Shock Wave Therapy (ESWT)|2000 impulses of 5 Hz and 0.32 mJ/mm2 , twice per week for 3 weeks
15750502|NCT04855942|Device|physiotherapy|therapeutic ultrasound, 12 times in 3 weeks
15750503|NCT04855929|Drug|ANV419|ANV419 administered by intravenous (IV) infusion
15750504|NCT04855929|Drug|CPI or Immunostimulatory agent|CPI or other immunostimulatory administred per treatment modalities
15750505|NCT04855916|Device|ABLE Exoskeleton|Participants will use the ABLE Exoskeleton to perform therapy activities (sit-to-stand transfers, walk, turns, balance exercises, normalized tests). Participants will perform a total of 10 training sessions of an approximate duration of 90 minutes.
15750506|NCT04855916|Device|KAFO Orthosis|Participants will use a pair of KAFO-type passive orthosis to perform therapy activities (sit-to-stand transfers, walk, turns, balance exercises, normalized tests). Participants will perform a total of 10 training sessions of an approximate duration of 90 minutes.
15750507|NCT04855903|Device|Covirtua Cognition software|Cognitive training with Covirtua Cognition software
15750508|NCT04855890|Procedure|Ablation|The ablation procedure will be performed during deep sedation using midazolam, fentanyl and a continuous infusion of propofol. Vital parameters will be monitored. For catheter access three 8F sheaths will be inserted into the femoral veins. A multipolar diagnostic catheter will be placed in the coronary sinus. Single transseptal puncture and insertion of a 8.5 F transseptal sheath or 12F Cryo-Sheath (FlexCath AdvanceTM, Medtronic, Minneapolis, MN, USA) will be followed by PV angiographies. Before or shortly after transseptal puncture unfractionated heparin will be repeatedly administered to maintain an activated clotting time between 250 and 400s.
15750509|NCT04855877|Drug|Oral tablet|Oral administration of 2 grammes tranexamic acid 2 hours before skin incision and 2 grammes oral tranexamic acid 4 hours after first administration
15750510|NCT04855877|Drug|Placebo|Oral administration of lactose tablet (placebo)
15750511|NCT04855864|Other|Follow-up of BCR TKA|Pre- and postoperative follow-up of patients treated with the BCR design by measuring PROMs, and clinical- and radiographic evaluation
15750512|NCT04855864|Other|Follow-up of BCS TKA|Pre- and postoperative follow-up of patients treated with the BCS design by measuring PROMs, and clinical- and radiographic evaluation
15750513|NCT04855851|Procedure|PAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAINING|The subjects of this group will receive an amount of six sessions that will be applied within 12 weeks. Every 15 days, the subjects will come for a consultation to receive a PNE session and review of the exercise program, which will be carried out 3 times a week for 12 weeks.
15750514|NCT04855851|Procedure|USUAL CARE|"Aerobic exercises will consist of a standard table of low intensity stretching exercises, commonly prescribed to fibromyalgia patients. There will be three series of 30 seconds of each stretch, having a total duration of approximately 40 minutes. Each session will be held twice a week, following the recommendations of the American College of Sport Medicine. Monitoring will be performed every 15 days by a physiotherapist."
15750515|NCT04855838|Device|Oral neuromuscular training|The oral device is used for 30 seconds, three times a day, before meals and implies new possibilities for training of the orofacial and pharyngeal muscles.
15750516|NCT04855825|Device|Robotic Exoskeleton Rehabilitation|Participants will be randomly assigned to one of the two groups. Each participant will receive 8 sessions of gait rehabilitation and therapy via traditional therapy techniques of using the robotic exoskeleton. This training will be provided by a licensed physical therapist.
15750517|NCT04855825|Other|Conventional Gait Therapy|Participants will be randomly assigned to one of the two groups. Each participant will receive 8 sessions of gait rehabilitation and therapy via traditional therapy techniques of using the robotic exoskeleton. This training will be provided by a licensed physical therapist.
15750518|NCT04855812|Device|MyoMo|To evaluate the usefulness of an upper extremity (UE) assistive device, called (MyoPro) in improving upper extremity activities in people with incomplete spinal cord injury (iSCI).
15750519|NCT04855812|Other|Myo-SB|To evaluate the usefulness of an upper extremity (UE) assistive device, called (MyoPro) in improving upper extremity activities in people with incomplete spinal cord injury (iSCI).
15750520|NCT04855812|Other|Control|To evaluate the usefulness of an upper extremity (UE) assistive device, called (MyoPro) in improving upper extremity activities in people with incomplete spinal cord injury (iSCI).
15750522|NCT04855786|Procedure|Thoracic duct drainage|drain placement into the thoracic duct
15750523|NCT04855773|Other|PrEPmate|"PrEPmate is a multi-component mHealth intervention grounded in the information, motivation, behavioral skills (IMB) theory of behavior change and developed through user-centered design. PrEPmate promotes personalized communication between patients and providers through interactive weekly check-in messages asking participants how PrEP is going, allowing navigators to identify patients needing more help in taking PrEP, and customized daily pill-taking reminder messages. Trained PrEP navigators reach out to participants who indicate they need assistance via text or phone call and provide tailored support. Additionally, the platform supports 2-way communication between patients and PrEP navigators, including reminders for upcoming clinic visits. Participants are provided links to key information about PrEP (PrEP Basics), and video testimonials of peers taking PrEP. Messages are available in English and Spanish. PrEPmate is aimed at both patients and PrEP navigators."
15750567|NCT04855357|Behavioral|Staff Training|A two-hour training for PSH staff on how to provide referrals to smoking cessation programs using materials previously developed from UCSF's 'Rx for change' curriculum for service providers, directed toward empowering PSH staff to provide referrals to local cessation services using the ask, advise, and refer approach. The training will address nicotine addiction, tobacco use among PSH residents, pilot data, brief cessation counseling (ask, advise, and refer), and local resources for cessation. Because PSH resident-PSH staff encounters will take place as part of routine care, the study team will request permission from a random sample of staff and resident dyads (n=40) to record these interactions to assess fidelity.
15750524|NCT04855773|Device|Dot Diary|Dot Diary is a mobile phone app that integrates an electronic pill-taking and sex diary and delivers real-time feedback on PrEP protection. Using the self-management model to increase self-efficacy and patient empowerment, participants log daily PrEP pill-taking and sexual behaviors in the app, which then provides real-time feedback on the level of protection achieved from PrEP (high, medium, low), and customized instructions on doses of PrEP needed to achieve or maintain high protection. Participants can also view a weekly and monthly calendar, including visualizations of the proportion of sex acts covered by PrEP. Finally, the Dot Diary app incorporates gamification components, including an ability to earn sex-positive badges, to increase engagement. Dot Diary is aimed only at patients.
15750525|NCT04855760|Drug|REL-1017|REL-1017 tablet
15750526|NCT04855747|Drug|REL-1017|REL-1017 tablet
15750527|NCT04855747|Drug|Placebo|Placebo tablet
15750528|NCT04855734|Behavioral|FAmily CEntered (FACE) pACP Intervention|The (approximately) weekly 3-session FACE-Rare intervention of approximately 45-60 minutes each is comprised of the CSNAT approach [Sessions 1 & 2] and Respecting Choices [Session 3].
15750529|NCT04855721|Drug|AUR101|Oral ROR-gamma inverse agonist
15750530|NCT04855721|Drug|Placebo|Placebo
15750531|NCT04855708|Other|Virtual visit|Patients randomized to this group will have a virtual 2-week post-operative visit
15750532|NCT04855708|Other|Office visit|Patients randomized to this group will have a in-person 2-week post-operative visit
15750533|NCT04855695|Drug|Acalabrutinib|"Each study drug is given according to a different schedule:
~Acalabrutinib: Oral, dosage per protocol, start cycle 1 and beyond according to schedule outlined in protocol"
15750534|NCT04855695|Drug|Venetoclax|Venetoclax: oral. daily, dosage per protocol, start cycle 3 and beyond according to schedule outlined in protocol
15750535|NCT04855695|Drug|Obinutuzumab|Obinutuzumab: intravenous infusion, dosage per protocol, drug during cycles 2 and beyond according to schedule outlined in protocol
15750536|NCT04855682|Other|Retrospective observation after 24 months after the spinal procedure|Retrospective evaluation of patients before the procedure, and prospective evaluation of patients 24 months after the spinal procedure, comparing the MRI changes and procedure impact on fatty muscle degeneration process
15750537|NCT04855682|Other|Retrospective observation after 12 months after the spinal procedure|Retrospective evaluation of the patient status before the procedure, and prospective evaluation of patients for 12 months after the spinal procedure, comparing the MRI changes
15750538|NCT04855682|Other|Prospective evaluation of patients after 12 and 24 months after the spinal procedure|Prospective evaluation of patients after 12 and 24 months after the spinal procedure, comparing the MRI changes
15750539|NCT04855656|Drug|RP-6306|Oral PKMYT1 Inhibitor
15750540|NCT04855643|Device|home-based active tDCS|Anodal tDCS will be applied to the left dorsolateral prefrontal cortex , while cathodal electrode will be positioned on the right dorsolateral prefrontal cortex .Caregivers will set up and administer tDCS for participants with ADRD at home. tDCS will be applied for 30 min at an intensity of 2mA, with 30 s ramping up and down. All sessions will be remotely supervised by trained research staff
15750541|NCT04855643|Device|home-based sham tDCS|Anodal tDCS will be applied to the left dorsolateral prefrontal cortex , while cathodal electrode will be positioned on the right dorsolateral prefrontal cortex .For sham stimulation,electric current will be applied only in the first 30s tDCS. All sessions will be remotely supervised by trained research staff
15750542|NCT04855630|Other|DREEM 2 Headband|Participants will wear the DREEM 2 headband for 3 months for a minimum of 4 out of 7 nights per week and will participate in its digital therapeutic CBT-I intervention (entails brain stimulation to improve slow wave sleep and sleep hygiene counseling tips to improve sleep behaviors).
15750543|NCT04855630|Other|Fitbit|Participants will partake in a guided exercise routine (30-minute mild circuit training session while VO2 is estimated from a Fitbit device twice per week for 3 months).
15750544|NCT04855617|Drug|Ocrelizumab|"Administer Ocrelizumab under the close supervision of an experienced healthcare professional with access to appropriate medical support to manage severe reactions such as serious infusion reactions.
~Initial dose: 300 mg intravenous infusion, followed two weeks later by a second 300 mg intravenous infusion.
~Subsequent doses: single 600 mg intravenous infusion every 6 months.
~Observe the patient for at least one hour after the completion of the infusion"
15750545|NCT04855591|Drug|SHR-1703|SHR-1703 will be administered subcutaneously
15750546|NCT04855591|Drug|Placebo|Placebo of SHR-1703 will be administered subcutaneously
15750547|NCT04855578|Other|In-Hopsital Patient Educational Brochure|The participant's medication list will be identified from the pharmacy database and validated with the participant's best possible medication history taken at time of admission by a pharmacist. Eligibility will be confirmed by the participant's treating medical team with support from the study investigators. Participants who are enrolled during the intervention phase will receive an educational brochure about the risks of chronic gabapentinoid use, and about how to safely discontinue use. The brochure is written using a sixth-grade vocabulary and has been validated in both English and French for comprehension and readability, including for people with mild cognitive impairment.
15750548|NCT04855578|Other|Physician Education about Gabapentinoid Prescription|An educational session about the purpose of the study and risks of gabapentinoid prescription will be delivered to physicians (staff and medical residents) on each study unit at both sites during the intervention period. The educational session will include a presentation by the chief of the medical service at the monthly teaching rounds, and an electronic message will be sent to all physicians on the medical service. Physicians will also be presented a brief overview of the educational brochure.
15750549|NCT04855565|Drug|ALY688-SR|single dose subcutaneous injection
15750568|NCT04855331|Procedure|Minimally invasive radical pancreatectomy|The tumor was completely removed by minimally invasive radical pancreatectomy. Routine lymph node dissection was performed and no tumor cells could be observed by microscope in the tissue within 1 mm from the resection margin (R0 resection).
15750569|NCT04855331|Procedure|Open radical pancreatectomy|The tumor was completely removed by minimally invasive radical pancreatectomy. Routine lymph node dissection was performed and no tumor cells could be observed by microscope in the tissue within 1 mm from the resection margin (R0 resection).
15750570|NCT04855305|Drug|Hyperpolarized 129Xe|Hyperpolarized 129Xe will be administered in multiple doses in volumes that are tailored to the participant's total lung capacity (TLC) followed by a breath hold of up to 15 seconds.
15750550|NCT04855552|Behavioral|Behavioral Weight-loss Program Via Telehealth|Investigators will use a manual based on the DPP, as adapted previously for the endometrial cancer population and now adapted for breast cancer survivors. Dr.Courtney McCuen-Wurst, has extensive experience in working with persons with overweight and obesity with medical comorbidities. She also has experience leading group interventions at our Center via telehealth. The content of the sessions addresses the domains associated with behavioral weight management including nutrition, exercise, stress and emotion management, and lifestyle modification strategies (to improve adherence to the diet and activity plan). Participants will monitor energy intake and physical activity daily to help them achieve recommended calorie and activity goals. Self-monitoring will be encouraged online with MyFitnessPal.com, which will be shared with the study staff to increase accountability and provide opportunity for feedback to participants.
15750551|NCT04855552|Behavioral|Behavioral Weight-Loss Program Via Telehealth - Weight Measures|Each participant will also be mailed a digital scale (Eat Smart) so they can weigh themselves each week and report their weight to the group leader; patients will be encouraged to take a picture of their weight on the scale after they step off (the number remains for 3-seconds) and send the picture to Dr. McCuen-Wurst. Participants will be encouraged to start with at least 1-minutes of moderately vigorous physical activity (e.g. brisk walking, swimming), at least five days per week, building up to at least 30-minutes per day (150-minutes per week) by week-6.
15750552|NCT04855552|Behavioral|Validated Surveys of Patient-Reported Outcomes|"The following surveys will be completed by participants pre- and post-intervention:
~COH-QOL Instrument - Breast Cancer Patient (QOL-BC)
~International Physical Activity Questionnaire (IPAQ) Short Form
~Patient Health Questionnaire (PHQ-9) (Depression)
~Acceptability of Intervention Measure
~The following survey will be completed post-intervention
~• Exit interview regarding acceptability of the program.
~The following measurements/clinical tests results will be collected and compared pre- and post-intervention:
~Anthropometric measurements: height (self-report); weight (as measured on scale provided by study)
~Mammographic breast density estimated in annual clinical mammogram"
15750553|NCT04855526|Drug|High THC/No CBD Marihuana|high THC (65 mg THC) and no CBD (0 mg CBD)
15750554|NCT04855526|Drug|High THC/High CBD Marihuana|high THC (65 mg THC) and high CBD (50 mg CBD)
15750555|NCT04855526|Drug|No THC/No CBD Marihuana|no THC (0 mg THC) and no CBD (0 mg CBD); placebo drug
15750556|NCT04855513|Drug|Metformin|Metformin is a medication used for treatment of diabetes. In this study it will be used to explore is potential role in prevention of preeclampsia. The drug will start before 12 week of pregnancy and continue till delivery
15750557|NCT04855487|Behavioral|Nurse-patient dyadic storytelling intervention|During the 5-week online intervention, adolescents/young adults with cancer will create their stories following the guiding questions and online meetings with nursing research staff. The target audience of their stories will be their primary nurses. This online dyadic storytelling intervention is designed to promote in-depth self-reflection and meaningful and therapeutic relationships within bedside nurses. The intervention is designed following the Story Theory and Pennebaker's Expressive Writing paradigm.
15750558|NCT04855474|Dietary Supplement|Amino Acid Intake|Participants will consume hourly (8 hours) isoenergetic, isonitrogenous beverages containing one of the three protein intakes (0.2g/kg/d, 1.2 g/kg/d, 2.0g/kg/d) assigned in a randomized order between the three metabolic trials. Drinks will be enriched with stable isotope [13C]phenylalanine. The use of stable isotope [13C]phenylalanine will allow for the determination of the fate of AA in the body (incorporation into body protein or oxidation) which can be used to determine protein (AA) requirements.
15750559|NCT04855448|Device|Micro Hand S robot and da Vinci robot|The surgeries are performed with the Micro Hand S robot and da Vinci robot
15750560|NCT04855448|Device|da Vinci robot|The surgeries are performed with the da Vinci robot
15750561|NCT04855435|Drug|MBS8(1V270)|The investigational medicinal product will be administered IV by infusion. Subjects will be treated in cycles of 42 days. A treatment cycle consists of four MBS8(1V270) infusions one week apart on Days 1, 8, 15, and 22, followed by a period of treatment pause of 21 days.
15750562|NCT04855422|Diagnostic Test|Allosure|AlloSure Analysis For the AlloSure test, 10-20 mL of blood will be obtained in Streck Cell-Free DNA BCT tubes and shipped to CareDx, Inc. (Brisbane, CA) at ambient temperature in insulated packaging to minimize temperature fluctuation. The AlloSure test will be performed at the CareDx CLIA/CAP-accredited clinical laboratory. Samples will be tested, and results provided within 3 days of blood draw
15750563|NCT04855422|Diagnostic Test|AlloMap|AlloMap Kidney is intended to aid in the identification of SPK transplant recipients who have a low probability of rejection at the time in testing in conjunction with standard clinical assessment. For the AlloMap-Kidney test, approximately two tubes of blood will be obtained in PAXgene Blood RNA tubes and shipped to CareDx, Inc. (Brisbane, CA), where it will be tested.
15750564|NCT04855383|Drug|The effect of intramuscular injection of triple doses of human chorionic gonadotropin in frozen embryo transfer cycles|Patients receive 5,000 IU of human chorionic gonadotropin by intramuscular injection, 72 hours before embryo transfer, on the day of embryo transfer, and 72 hours after embryo transfer.
15750565|NCT04855370|Device|Non-invasive hemodynamic measurements|A patient profile will be set up in the Edwards EV1000 clinical platform by inputting the patient's demographic information. One or two Edwards ClearSight finger cuffs will be placed on the index, middle, and/or ring finger on one hand of the patient. A pressure controller will be secured by a forearm strap where the finger cuffs will be connected to the pressure controller. The pressure controller will be connected to the Edwards EV1000 clinical platform monitor. A heart reference sensor (HRS) will be connected to the pressure controller, a finger cuff, and to the patient at heart level. The Edwards EV1000 clinical platform will calibrate the finger probes, then record measurements for 10-30 seconds every 15 minutes for 12 to 24 hours. If two finger probes are available, measurements will alternate between fingers.
15750566|NCT04855357|Behavioral|Resident counselling|One hour, one-on-one counseling for residents
15750571|NCT04855292|Drug|TG103 injection|TG103 injection, SC, once weekly
15750572|NCT04855292|Drug|Placebo|Placebo control, SC, once weekly
15750573|NCT04855279|Other|neutral sodium fluoride|Topically applied
15750574|NCT04855279|Other|ACP-CCP gel|Topically applied
15750575|NCT04855279|Other|nano-hydroxyapatite solution|Topically applied
15750576|NCT04855279|Other|glycerine|Topically applied
15750577|NCT04855266|Drug|Sucrose|5 mg/kg of intravenous iron sucrose (maximum dose of 200 mg). Iron sucrose will be diluted
15750579|NCT04855266|Diagnostic Test|Tilt Table Test|A table that adjusts the body position from horizontal to vertical to simulate standing up. Heart rate and blood pressure are monitored throughout the test.
15750580|NCT04855253|Drug|E7777|E7777 is a recombinant fusion toxin consisting of full-length human IL-2 fused to the catalytic domains of diphtheria toxin. E7777 is preferentially bound to and internalized by cells expressing the high affinity form (CD25+) of the IL-2 receptor.
15750581|NCT04855240|Drug|ACP-044 Dose A|Oral dose of ACP-044 Dose A
15750582|NCT04855240|Drug|ACP-044 Dose B|Oral dose of ACP-044 Dose B
15750583|NCT04855240|Drug|Placebo|Oral dose of placebo
15750584|NCT04855227|Procedure|robotic-assisted ventral hernia repair|"Laparoscopic ventral hernia repair With the subject under general anesthesia, several small incisions are made in the abdomen. Ports are placed, the abdomen is insufflated, and laparoscopic instruments as well as a laparoscope are inserted to complete the repair. The retrorectus space is developed for mesh placement to repair the defect. The repair technique will be per the surgeon's standard of care.
~Robotic-assisted ventral hernia repair With the patient under general anesthesia, several small incisions are made in the abdomen. Ports are placed, the abdomen is insufflated, and the da Vinci Robotic Surgical System (Intuitive) is docked to the subject and used to complete the procedure. The retrorectus space is developed for mesh placement to repair the defect. The repair technique will be per the surgeon's standard of care."
15750585|NCT04855214|Other|Qualitative Analysis|Mixed methods analysis of the user's experience with upper limb prosthetics.
15750588|NCT04855188|Device|YVOIRE Y-Solution 540|Injection into the deep dermis layer and/or subcutaneous layer in the nasolabial folds based on the randomization assignment.
15750589|NCT04855188|Device|YVOIRE volume plus|Injection into the deep dermis layer and/or subcutaneous layer in the nasolabial folds based on the randomization assignment.
15750590|NCT04855175|Device|Synthetic Bone Allograft (ClearFit)|Patients in this arm will receive ClearFit (synthetic bone allograft)
15750591|NCT04855175|Other|Autograft|Patients in this arm will use patient's own bone
15750592|NCT04855149|Other|Patient satisfaction|Patient satisfaction evaluated with EVAN LR questionnaire
15750593|NCT04855136|Biological|BB2121|CAR T Cell Therapy
15750594|NCT04855136|Drug|CC-220|Cereblon (CRBN) E3 ligase modulatory compound (CELMoD)
15750595|NCT04855136|Drug|BMS-986405|gamma secretase inhibitor (GSI)
15750596|NCT04855136|Drug|Pomalidomide|immunomodulatory agent
15750597|NCT04855136|Drug|Dexamethasone|corticosteroids
15750598|NCT04855136|Drug|Bortezomib|inhibitor of the proteasome
15750599|NCT04855123|Other|retinal imaging|OCT-angiography, Retinophotography, ocular fundus, Pulsed air tonometer
15750600|NCT04855123|Other|paraclinical surveillance|blood and urine sampling, assessment of kidney function with creatinine, protein, albumin levels and CKD-EPI equation)
15750601|NCT04855110|Drug|Warfarin Sodium started on Day 2 after caesarean section (in a dose that achieves a therapeutic level as indicated by the cardiology consultant)|Warfarin started on day 2 after caesarean section in patients with mechanical heart valve prosthesis
15750602|NCT04855110|Drug|Warfarin Sodium started on day 5 after caesarean section (in a dose that achieves a therapeutic level as indicated by the cardiology consultant)|Warfarin started on day 5 after caesarean section in patients with mechanical heart valve prosthesis
15750603|NCT04855097|Diagnostic Test|BVA-100|The BVA-100 is a medical device that calculates human blood volume using the method of tracer dilution. The device utilizes a tracer of human serum albumin tagged with iodine-131 to measure injected intravascularly and a series of timed blood draws. The amount of tracer in each blood draw is used to calculate the unknown blood volume. Data inputs come from the measured characteristics of subject blood samples (hematocrit and tracer concentration) and tracer calibration standards. The package also calculates the subject expected (or ideal) blood volume from physical parameters. Hyper- or hypovolemia, associated red blood cell volumes, and tracer transudation rate are reported, with statistics showing the quality of the results.
15750604|NCT04855084|Other|Monolithic FDPs: before adjustment|Before the occlusal adjustment, Occlusal relationship recording of the 3-unit monolithic FDPs which was fabricated following the complete digital work-flow.
15750605|NCT04855084|Other|Monolithic FDPs: after adjustment|After the occlusal adjustment, Occlusal relationship recording of the 3-unit monolithic FDPs which was fabricated following the complete digital work-flow.
15750606|NCT04855084|Other|Metal fused porcelain FDPs: before adjustment|Before the occlusal adjustment, Occlusal relationship recording of the 3-unit metal fused porcelain FDPs which was fabricated following the complete conventional manufacturing procedure.
15750607|NCT04855084|Other|Metal fused porcelain FDPs: after adjustment|After the occlusal adjustment, digital occlusal relationship recording was done of the 3-unit metal fused porcelain FDPs which was fabricated following the complete conventional manufacturing procedure.
15750608|NCT04855071|Device|Non-ablative radiofrequency application|Non-ablative radiofrequency application will be applied with MJS intracavitary probe, in monopolar application, reaching a temperature between 42-45ºC in the tissues (according to the patient's tolerance), and with a power of 50% until the desired temperature is reached. It will be applied with a frequency that will be individualized according to the maximum level of energy absorption by the patient's tissues (between 0.8-1.2MHz) and with a dose of approximately between 3-4 KJ depending on the application time (20 minutes / session). In addition, they will be applied 1 session per week. The treatment will last 8 weeks.
15750609|NCT04855071|Other|Usual intervention|The usual intervention will consist of supervised individualized sessions that will include application of exercises to balance the pelvis and their muscles, treatment of trigger points, teaching activation of the transverse abdominis with ultrasound biofeedback and teaching reflex activation exercises of the transverse abdominis and pelvic floor muscles in different body positions. In addition, standards of water, urination, food, defecation, postural hygiene and physical activity will be provided. It is also recommended different life habit advices related to tobacco use, constipation, etc.
15750610|NCT04855058|Other|online survey(or phone survey)|A questionnaire about the current symptoms and satisfaction for received treatment will be conducted over google survey(or the phone survey) for patients.
15750611|NCT04855045|Drug|sepofarsen|RNA antisense oligonucleotide for intravitreal injection
15750612|NCT04855032|Behavioral|Reactive Perturbations|A novel device will be used to apply controlled mediolateral perturbations to participants' trunk as they walk on a treadmill, requiring reactive responses to avoid a loss of balance. All perturbations will have a duration of 200 ms, and will be applied immediately after onset of the swing phase with either the paretic or non-paretic leg. If in a given training session, a participant does not experience any losses of balance, the perturbation magnitude will be increased in the next training session. Perturbations will begin at 3% body weight (BW), and will progress in increments of 3% BW up to a maximum of 15% BW. The structure of the Reactive perturbation session will be identical to that used for Proactive perturbation training sessions, including overground trials, treadmill trials without perturbations, and Perturbed and Catch trials in which Perturbations are delivered.
15750613|NCT04855032|Behavioral|Proactive Perturbations|A novel device will be used to perturb the relationship between pelvis motion and step width by applying mediolateral forces to participants' legs. Participants will first perform a 3-minute overground walking trial at their self-selected speed, in which they do not interact with the perturbation device. Participants will then perform a 3-minute treadmill walking trial at their self-selected speed, in which they again do not interact with the perturbation device. Participants will then perform a series of alternating 3-minute Perturbed and Catch trials, all at their self-selected speed. For the Perturbed trials, perturbations will be delivered in each step throughout the trial. For the Catch trials, perturbations will cease for the final minute of walking. A total of 5 Perturbed and 5 Catch trials will be performed. Finally, participants will perform a 3-minute overground walking trial at their self-selected speed, in which they do not interact with the perturbation device.
15750614|NCT04855019|Procedure|shoulder periarticular injection, suprascapular and axillary nerve block|"In the PI group, a mixture of 30 ml bupivacaine 0.5% and 30 ml saline solution will be injected by the orthopedist after the wound is closed.
~In the CSAB group, a total of 20 ml 0.5% bupivacaine, 10 ml to the suprascapular notch, 10 ml to the axillary nerve, will be administered preoperatively by the anesthesiologist under ultrasound guidance."
15750615|NCT04855006|Biological|Vaginal Microbiome Transplant|Vaginal Microbiome Transplant is given at least once and up to three times. The transplant is admitted with a syringe
15750616|NCT04855006|Biological|Vaginal Microbiome Transplant Placebo|Vaginal Microbiome Transplant Placebo is given at least once and up to three times. The transplant Placebo is admitted with a syringe
15750617|NCT04855006|Other|No intervention|Donors have no intervention. This group deliver the transplant to arm 'Vaginal Microbiome Transplant'.
15750618|NCT04854993|Drug|Sugammadex 6 mg/kg|i.v. injection of an increased (by 50%) dose of sugammadex to reverse dNMB
15750619|NCT04854993|Drug|Sugammadex 4 mg/kg|i.v. injection of a standard dose of sugammadex to reverse dNMB
15750620|NCT04854980|Other|Blood Sample|Blood sample, 2- to 5 tea spoon full (between 10 to 25 mL approximately) between 43 to 96 days after first dose of the vaccine.
15750626|NCT04854941|Other|Probiotics|Probiotics (10^9 CFU of each strain: Lactobacillus rhamnosus PDV 1705, Bifidobacterium bifidum PDV 0903, Bifidobacterium longum subsp. infantis PDV 1911 and Bifidobacterium longum PDV 2301) 3 times per day in addition to standard treatment regimen for 2 weeks
15750627|NCT04854928|Drug|LTX-109 gel, 3%|A Single dose of LTX-109 gel will be applied topically to both nostrils by a qualified health professional. A large drop of IMP will be applied into each nostril and distributed to cover the whole area of the nostril.
15750628|NCT04854928|Drug|Placebo gel|A Single dose of placebo gel will be applied topically to both nostrils by a qualified health professional. A large drop of IMP will be applied into each nostril and distributed to cover the whole area of the nostril.
15750629|NCT04854915|Behavioral|LOOP + mHealth technology assisted exercise counselling|Participants will complete a 3 month exercise and physical activity intervention supported by mHealth technology
15750630|NCT04854915|Behavioral|LOOP Only|Participants will complete the LOOP @ Alder Hey programme
15750631|NCT04854902|Procedure|Free gingival graft|1.5-2 x 5 x 10 mm size epithelialized graft harvested from the palate is stabilized in the mandibular anterior single-tooth recession region
15750632|NCT04854902|Procedure|Cyanoacrylate|N-Butyl-Cyanoacryle is applied to stabilize the graft to the recipient bed and to coat the donor site wound
15750633|NCT04854902|Procedure|Suture|The graft is stabilized with 6/0 polyvinylidene fluoride suture to the recipient bed
15750634|NCT04854889|Drug|Decitabine|Demethylating agents
15750661|NCT04854681|Drug|TQB2928 Injection|4 weekly IV infusions (Days 1, 8, 15, and 22) of TQB2928 in each 28-day treatment cycle until unacceptable toxicity, documentation of confirmed progressive disease (PD), or subject withdrawal.
15751370|NCT04848545|Other|Observational|Prenatal maternal exposure to endocrine disrupting chemicals
15750635|NCT04854876|Dietary Supplement|5-ALA-Phosphate + SFC (5-ALA+SFC)|The food supplement 5-Aminolevulinic acid phosphate and Sodium ferrous citrate (5-ALA-Phosphate + SFC) will be administered orally daily for 28 days. The dose will be in total 3 capsules of 50 mg 5-ALA-Phosphate and 28.68 mg SFC (3.04 mg as Fe) per day, 2 capsules in the morning and 1 capsule in the evening resulting in 150 mg 5-ALA-Phosphate and 86.04 mg SFC ( 9.12 mg as Fe).
15750636|NCT04854863|Diagnostic Test|Comprehensive assessment of respiratory muscle function.|Comprehensive assessment of respiratory muscle function to the point of its invasive assessment with recordings of twitch transdiaphragmatic pressure in response to magnetic phrenic nerve stimulation and stimulation of the lower thoracic nerve roots.
15750637|NCT04854850|Device|Apollo|The Apollo System offers a convenient novel non-invasive, non-habit-forming solution to improve performance and recovery under stress in children and adults by delivering gentle wave-like vibrations to the body that improve autonomic nervous system balance in real time (Siegle & Rabin et al., under review). The gentle vibrations delivered by the Apollo System are extremely low intensity in that they are typically just barely noticeable or perceptible by the user. Additionally, the range of frequencies and intensities of the Apollo System have been safely used in numerous commercial products without adverse events reported, including sexual vibrators and massagers. Apollo vibrations activate touch receptors in the skin and are perceived as safety signals by the brain resulting in decreased stress, improved recovery, focus, and energy.
15750638|NCT04854837|Drug|Remdesivir|Remdesivir treatment
15750639|NCT04854824|Drug|Recommended treatment schedule|Relatively selective Cox-2 inhibitors, Corticosteroids (Dexamethasone), Anticoagulants (LMW heparin), Gentle oxygen therapy
15750640|NCT04854824|Drug|Control treatment schedule|Treatment regimens different from the recommended one according to family physician personal practice
15750642|NCT04854798|Device|Splenic Ultrasound|Daily ultrasound application to the spleen of approximately 18 minutes for up to 7 days, in addition to standard clinical care
15750643|NCT04854785|Other|[18F]FEPPA PET scan|One [18F]FEPPA PET for translocator protein (TSPO) VT and one MRI scan
15750644|NCT04854785|Other|[11C]SL25.1188 PET scan|One [11C]SL25.1188 PET scan for monoamine oxidase B (MAO-B) VT and one MRI scan
15750645|NCT04854772|Behavioral|Mind Body Syndrome Therapy for Long Covid|The intervention consists of a mind-body based intervention for the COVID long haul syndrome. The components of the intervention include knowledge therapy, desensitization, emotional expression, and stress reduction techniques.
15750646|NCT04854759|Drug|Amantadine Hydrochloride|100 mg, capsule
15750647|NCT04854759|Drug|Placebo|100 mg, capsule
15750648|NCT04854746|Biological|VXA-GI.1.NN|GI.1 oral vaccine tablet
15750649|NCT04854746|Biological|Placebo Tablet|Tablets matching in number and appearance to active vaccine tablets
15750650|NCT04854720|Device|Fuji® II LC CAPSULE|"Fuji® II LC is a resin modified glass ionomer contained, fluoride releasing and light-cured material. Since the product is tolerant to moisture and saliva, it's used for fissure sealant of newly erupted teeth.
~Test 1 newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 20% cavity conditioner was applied to all surfaces of the tooth for 10 seconds.The tooth surface was rinsed with water and dried. Thereafter, Fuji® II LC was applied to the pits and fissures on the tooth surface using a brush. Then, the varnish was applied and cured according to the manufacturer's instructions."
15750651|NCT04854720|Device|Clinpro™ XT Varnish|"Clinpro™ XT Varnish is a resin modified glass ionomer containing, fluoride-releasing, light-cured varnish. Since the product is tolerant to moisture and saliva, it is used for fissure sealant of newly erupted teeth. The product can be recharged with fluoride using fluoride-containing products.
~Test 2 newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 35% phosphoric acid was applied to all surfaces of the tooth for 15 seconds.Then the tooth surface was rinsed with water and dried. Thereafter, Clinpro™ XT Varnish was applied in compliance with the manufacturers' instructions."
15750652|NCT04854720|Device|Beautifil Flow|"Beautiful Flow is a Giomer contained, fluoride releasing and light cured material. The product contains pre-reacted glass ionomer particles (PRG). It is a high water resistant material. It is used for fissure sealant.
~Test 3 newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 7% phosphoric acid was applied to all surfaces of the tooth for 10 seconds. Then the tooth surface was rinsed with water and dried. Afterwards, a two-stage self-etch adhesive system was applied. Thereafter, Beautiful Flow was applied in compliance with the manufacturers' instructions."
15750653|NCT04854720|Device|Fuji Triage® CAPSULE|"Fuji Triage® is a new generation glass ionomer containing with low viscosity, high fluoride content and light curing materials. Since the product is tolerant of moisture and saliva, it is used for fissure sealant of newly erupted teeth.
~Control newly erupted first permanent molars were cleaned with a pumice paste using a bristle brush and isolated with cotton rolls. Then, 20% cavity conditioner was applied to all surfaces of the tooth for 10 seconds.Then the tooth surface was rinsed with water and dried. Thereafter,Fuji Triage® was applied to the pits and fissures on the tooth surface using a brush. Thereafter, the varnish was applied and cured according to the manufacturer's instructions."
15750659|NCT04854694|Device|FaceView Mask™|transparent surgical N95 respirator designed to improve communication
15791675|NCT04519385|Drug|Tocilizumab|Tocilizumab therapy
15750662|NCT04854668|Drug|Anlotinib hydrochloride capsule|Anlotinib hydrochloride capsule 12mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)；
15750663|NCT04854668|Drug|Bevacizumab|Bevacizumab 7.5mg/kg, intravenous drip, on Day 1
15750664|NCT04854668|Drug|Oxaliplatin|Oxaliplatin 130mg/m2, intravenous drip, on Day 1；
15750665|NCT04854668|Drug|Capecitabine|Capecitabine 850mg/m2 administrated orally twice daily from Day 1-14.
15750666|NCT04854655|Other|Conventional resin composite|nanofilled resin composite
15750667|NCT04854655|Other|Activa Presto|calcium and phosphate hybrid material
15750668|NCT04854655|Other|Giomer|fluoride releasing hybrid material
15750669|NCT04854642|Drug|Ladarixin|A single oral dose of 400 mg of ladarixin (two 200 mg capsules) was administered to healthy male and female volunteers under fed (Test treatment) and fasting (Reference treatment) conditions in two consecutive study periods, according to a two-way crossover design, with a wash-out interval of at least 14 days between the two administrations.
15750670|NCT04854629|Other|Spinomed active|Wearing of the orthosis 2-3 h/twice a day for 16 weeks Supplementation of a maximum of 1000 mg/d calcium and 800 IE/d vitamin D
15750671|NCT04854616|Behavioral|CoSTED Intervention|The provision of an e-cigarette starter kit and training in its use.
15750672|NCT04854603|Other|Food|Dairy products with regular and reduced sugar content and water control.
15750673|NCT04854577|Procedure|Opioid Free Anesthesia|Patients will be administered a combination of a pre-incisional pecto-intercostal fascial plane block and a standardized opioid free anesthetic regimen consisting of dexmedetomidine, esketamine and lidocaine.
15750674|NCT04854577|Procedure|Traditional Anesthetic Regimen|Patients will be administered a traditional anesthetic regimen which is based on sufentanil dosage. The dosage is at the discretion of the attending anesthesiologist.
15750675|NCT04854564|Behavioral|Prehabilitation intervention|The investigators will identify participants' perceived important information to develop a prehabilitation intervention in this study. Prehabilitation intervention consisting of physical activities, nutrition, and stress management.
15750676|NCT04854564|Behavioral|Caregiver intervention|The investigators will provide caregivers with variety of educational resources for patients experiencing ESLD.
15750677|NCT04854551|Drug|Naltrexone|Naltrexone is an opioid antagonist with primary action at the mu opioid receptor.
15750678|NCT04854551|Other|Placebo|Placebo will be used to control for expectancy effects
15750679|NCT04854538|Drug|Ekmasonid|1 extended release tablet contains 9 mg Budesonide
15750680|NCT04854538|Drug|Uceris (first dose)|1 extended release tablet contains 9 mg Budesonide
15750681|NCT04854538|Drug|Uceris (second dose)|1 extended release tablet contains 9 mg Budesonide
15750682|NCT04854525|Radiation|Pre reconstruction Radiotherapy|Previous PMRT
15750683|NCT04854512|Drug|Metformin DR|Delay-Release Metformin
15750684|NCT04854512|Drug|Metformin IR|Immediate Release Metformin
15750685|NCT04854512|Drug|Metformin DR Placebo|Metformin DR Placebo
15750686|NCT04854512|Drug|Metformin IR placebo|Metformin IR placebo
15750687|NCT04854499|Drug|Magrolimab|Administered intravenously
15750688|NCT04854499|Drug|Pembrolizumab|Administered intravenously
15750689|NCT04854499|Drug|Docetaxel|Administered intravenously
15750690|NCT04854499|Drug|5-FU|Administered intravenously
15750691|NCT04854499|Drug|Cisplatin|Administered intravenously
15750692|NCT04854499|Drug|Carboplatin|Administered intravenously
15750693|NCT04854486|Other|GSE and Xylitol|Participants are given the experimental treatment to be used for 7 days.
15750694|NCT04854486|Drug|Control Placebo|Saline
15750695|NCT04854473|Device|Exero Medical Leak Detection System|"the Exero Leak Detection System components used in this study are:
~Smart drain - a surgical drain with added sensing electrodes
~Transceiver /Recording Unit (TRU) - a wearable placed outside the body on intact skin and is connected to the implanted electrodes. The unit also acts as a wireless connection to the Monitoring Subsystem.
~Monitoring Subsystem - a tablet or a computer connected wirelessly to the transceiver providing logging, applying analysis algorithms on the logged signals and providing indication/alerts to the medical staff derived from the signals recorded by the electrodes."
15750696|NCT04854460|Drug|Revemact|1 tablet contains 6 mg Ivermecin
15750697|NCT04854460|Drug|Stromectol (first dose)|2 tablet contain 6 mg Ivermecin
15750698|NCT04854460|Drug|Stromectol (second dose)|2 tablet contain 6 mg Ivermecin
15750699|NCT04854447|Device|Single-Vision Spectacles|Spectacle correction for myopia treatment
15750700|NCT04854434|Drug|Selinexor|Participants will receive selinexor oral tablets.
15750701|NCT04854434|Drug|Pembrolizumab|Participants will receive pembrolizumab intravenously.
15750702|NCT04854434|Drug|Trifluridine|Participants will receive trifluridine oral tablets as SOC.
15750703|NCT04854434|Drug|Tipiracil|Participants will receive tipiracil oral tablets as SOC.
15750704|NCT04854421|Device|VBC|Body Composition will be measured using the VBC system that takes under 60 seconds per scan. Image capture for VBC will include taking a series of four photos using a smartphone camera. Data from the camera will be downloaded to a local computer and then securely sent to the cloud for automated analysis and results generation. We will conduct two consecutive scans (image captures) for each research participant.
15750705|NCT04854408|Other|healthcare workers with the coronavac vaccine|Health workers who are vaccinated will fill in the 20-question survey electronically.
15750706|NCT04854395|Drug|Marcain 5 mg/ml|Total volumes of Marcain differs in each arm, depending on which nerve blocks the patients is randomized to receive. Sham block does not include injection of placebo saline, due to the risk of hydrodissection between the anatomical sections which may erase the isolation of the different nerve blocks. Instead the sham block include imitation of the real nerve block, including correct placement of the needle on the target for the block.
15750707|NCT04854382|Behavioral|Tailored information|Tailored information about coronavirus for patients with chronic kidney disease by information videos followed by a teach back procedure
15750708|NCT04854369|Drug|68 Ga-PSMA-11 prepared using a PSMA-11 Sterile Cold Kit|The PSMA-11 Sterile Cold Kit is supplied as a kit for preparation of radiolabeled Gallium-68 PSMA-11 Injection, with 3 configurations (A, B or D) to accommodate the specificities of the 68Ge/68Ga generator that is used.
15750709|NCT04854356|Other|Exercise with blood flow restriction (BFR)|All participants completed high-intensity interval exercise plus (1) BFR applied during exercise phase, or (2) BFR applied during interval phase, or (3) no BFR applied.
15750710|NCT04854343|Diagnostic Test|Secretory leukocyte protease inhibitor (SLPI) in prostate cancer|"7 ml of peripheral blood and a urine sample for the determination of SLPI concentration. Blood samples will be promptly processed to obtain sera; both sera and urine will be stored at -80°C in the laboratory. The levels of SLPI in the serum and in the urine will be quantitated by an ELISA assay by using the Human SLPI Quantikine ELISA Kit. SLPI level will be measured at diagnosis and during the follow-up (3, 9, 15 months and in case of progression).
~Immunohistochemistry protocol for SLPI immunostaining to investigate SLPI levels prostate tissue"
15750711|NCT04854343|Diagnostic Test|Determination of molecular alterations|The presence of ETS translocation (or of ETS overexpression) will be tested on bioptic samples in each patient as for routine diagnostic procedures. First, ERG overexpression will be investigated by ERG immunostaining. The samples negative for ERG immunostaining will be studied for TMPRSS2-ERG translocation either by in situ FISH or by a translocation-specific RT-PCR. Next, the biopsies negative for TMPRSS2-ERG will be tested for the overexpression of other ETS proteins (ETV1, ETV4, ETV5 and for others rarely occurring ETS). When possible, it will be determined the status of pTEN gene, the tumor suppressor most frequently lost in prostate patients. The patients negative for the overexpression of the ETS proteins will be tested for SPINK1.
15750712|NCT04854343|Diagnostic Test|Secretory leukocyte protease inhibitor (SLPI) Healthy|"SLPI level will be measured also in the serum and in the urine from controls (patients with BPH and healthy subjects).
~7 ml of peripheral blood and a urine sample for the determination of SLPI concentration. Blood samples will be promptly processed to obtain sera; both sera and urine will be stored at -80°C in the laboratory. The levels of SLPI in the serum and in the urine will be quantitated by an ELISA assay by using the Human SLPI Quantikine ELISA Kit."
15750713|NCT04854330|Dietary Supplement|Ketone monoesters|A Kme commercially available supplement will be given to the participants in the form of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate (ΔG®; TΔS Ltd, UK, Oxford, UK; 0.30 ml.kg-1 body mass) and will be ingested with water and cherry-flavoured stevia in a total volume of 100 ml.
15750714|NCT04854330|Dietary Supplement|Placebo|In the placebo condition, participants will consume 100 ml of water and cherry-flavoured stevia followed by the same 20 ml calorie-free sparkling spring water.
15750715|NCT04854317|Procedure|Endoscopic gastroplasty or Intragastric balloon placement|Endoscopic bariatric procedures
15750716|NCT04854304|Diagnostic Test|Fast Breast Abbreviated Magnetic Renounce Imaging|Fast Breast MRI Imaging
15750717|NCT04854291|Other|Administration of donor FMT|Intracaecal infusion of FMT
15750718|NCT04854291|Other|Administration of placebo|Intracaecal infusion of carrier solution
15750719|NCT04854278|Other|Massive Open Online Course (MOOC)|Combination of knowledge training with video scenarios and game-based learning provided to endovascular team members: surgeons, nurses and anesthetists
15750721|NCT04854252|Drug|Fentanyl|TIVA opioid-containing anesthesia: fentanyl in a bolus dose of l3 mcg/kg (corrected weight) TIVA opioid-free anesthesia: dexmedetomidine 1-1.5 mcg/kg (corrected weight) for 40 minutes
15750722|NCT04854239|Procedure|Half-guided implant placement|The surgery was performed under local anaesthesia in both groups, half-guided implant placement was carried out based on randomization.
15750723|NCT04854226|Dietary Supplement|Macronutrients_CARB|Breast milk 150 to 170 mL/d; Target fortification: 9.0 g/100mL COH, 3.0 g/100mL protein, 4.0 g/100mL fat, 86.4 kcal/100mL
15750724|NCT04854226|Dietary Supplement|Macronutrient_FAT|Breast milk 150 to 170 mL/d; Target fortification: 5.5 g/100mL COH, 3.0 g/100mL protein, 5.5 g/100mL fat, 86 kcal/100mL
15750725|NCT04854213|Device|Stereotactic Body Radiation Therapy (SBRT)|Radiation treatment
15750726|NCT04854200|Device|Medtronic HeartWare ™ HVAD™ System|The Medtronic HeartWare™ HVAD™ System includes a ventricular assist device (VAD) that helps the heart pump and increases the amount of blood that flows through the body in patients with advanced heart failure.
15750727|NCT04854187|Device|N95 Mask/Indoor air purifier: Including sham|Participants will be using indoor air purifier and N95 mask (control arm with sham filters). The effect will be studied on blood pressure and blood glucose levels.
15750728|NCT04854174|Drug|ZN-d5|Oral agent; 25 mg formulation
15750729|NCT04854161|Behavioral|Empathic Attunement to Affect Training|"Empathic Attunement to Affect:
~Empathy and neuroscience Therapeutic Presence
~Opening receptivity channels Empathic reflections and landscapes (external, meaning and feeling)
~Types of emotions: Primary (adaptive, maladaptive), Secondary. Emotion Scheme Types of experiential responses: conjectures, exploration.
~Working with Core emotions Types of experiential responses: Evocation and Empathic affirmation,
~Empathy and Emotion Productivity Types of experiential responses: Empathic formulation, process suggestion Difficult situations: working on assertive anger and self-soothing Types of experiential responses: Facilitative Congruence"
15750730|NCT04854161|Behavioral|Compassion Training|Compassion Training Introduction to Mindfulness Compassion toward a significant other Compassion toward a generic other Self-compassion Tonglen Compassion toward a difficult other
15750731|NCT04854161|Behavioral|Focusing Oriented Therapy Training|Focusing-Oriented Therapy training Introduction to focusing Acceptance and empathy as the main focusing attitudes Fels-sense markers Felt sense, handle and resonance Hakomi Therapy The Safe Place. Focusing with a challenging person
15750732|NCT04854148|Other|Smartphone Movement Health Assessment|Participants will perform the assessment using an App installed on a smartphone device. Following the smartphone assessment, gold standard clinical assessments will be performed and scored for comparison
15750733|NCT04854135|Device|CGM4Home|FreeStyle Libre 2 Continuous Glucose Monitoring System manufactured by Abbott
15750764|NCT04853875|Drug|Tetracycline, Metronidazole, Bismuth subcitrate|52 participants (Group A) are randomly assigned to receive intraluminal eradication of H. pylori with medicament containing Tetracycline, Metronidazole, and Bismuth subcitrate
15750765|NCT04853875|Drug|Amoxicillin, Metronidazole, Clarithromycin|52 participants (Group B) are randomly assigned to receive intraluminal eradication of H. pylori with medicament containing Amoxicillin, Metronidazole, and Clarithromycin
15750766|NCT04853862|Other|questionnaire|Questionnaire for health-related quality of life evaluation
15750734|NCT04854122|Behavioral|Combined exercise intervention|The exercise intervention will last 12 weeks and will consist of a supervised combined aerobic and resistance training program with a frequency of 3 days/week. Aerobic exercise will be part of all three sessions, with resistance exercise during two out of three sessions. Training sessions will be supervised by personal trainers to ensure the safe use of the equipment and the correct form when performing each exercise. The first 3 weeks of the intervention will be familiarization with the exercises and the program. After a warm-up, the participant will perform 30 min of aerobic exercise at a heart rate of 65% of the participant's maximum heart rate [43], which increases to 65-85% during weeks 4-12 of the intervention. The resistance exercise part will include all major muscle groups, both upper and lower body.
15750735|NCT04854122|Behavioral|Usual care / Sham intervention|The control condition consists of usual activities.
15750736|NCT04854096|Drug|NS-018|Experimental
15750737|NCT04854096|Drug|Best Available Therapy|Active Comparator
15750738|NCT04854083|Drug|Semaglutide, 1.34 mg/mL|The low-calorie diet (LCD) has a phase run-in period for 13 weeks for all participants including 8 weeks of total LCD followed 5-week gradual re-introduction of food (replacement of the VLCD products by one meal/week). During re-introduction of food, the subjects will be randomly assigned to semaglutide 1.34mg/ml (subcutaneous administration, dose escalation 0.25 mg once weekly for 4 weeks, 0.5 mg once weekly for 4 weeks, where after 1.0 mg once weekly) until the end of the study (12 months). The participants will receive lifestyle counselling throughout the study.
15750739|NCT04854083|Drug|Placebo|The low-calorie diet (LCD) has a phase run-in period for 13 weeks for all participants including 8 weeks of total LCD followed 5-week gradual re-introduction of food (replacement of the VLCD products by one meal/week). During re-introduction of food, the subjects will be randomly assigned to placebo (subcutaneous administration, dose escalation 0.25 mg once weekly for 4 weeks, 0.5 mg once weekly for 4 weeks, where after 1.0 mg once weekly) until the end of the study (12 months). The participants will receive lifestyle counselling throughout the study.
15750740|NCT04854070|Device|IVUS|IVUS-guided approach in patients with complex coronary lesions undergoing PCI
15750741|NCT04854070|Device|Angio|Angio-guided approach in patients with complex coronary lesions undergoing PCI
15750742|NCT04854057|Other|AIH - Intermittent Hypoxia - hypoxia air mixture|Participants will breathe intermittent low oxygen via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of fraction of inspired oxygen (FIO2)=0.10±0.02 (hypoxia). Participants will receive treatment 4 times per week.
15750743|NCT04854057|Other|SHAM - Intermittent Room Air - room air mixture|Participants will breathe intermittent room air via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of fraction of inspired oxygen (FIO2)=0.21±0.02 (normoxia). Participants will receive treatment 4 times per week.
15750744|NCT04854057|Device|TESS - Transcutaneous Electrical Spinal Cord Stimulation + Functional Task Practice|Participants will receive transcutaneous electrical stimulation to the cervical spinal cord using the TESCoN device developed by SpineX, Inc. Training will consist of progressive functional task practice for upper extremity motor training. A total of 24 treatment sessions, which will last 45 minutes per session, will be completed in 3 weeks (4 days/week) per crossover arm.
15750745|NCT04854044|Drug|Akt/ERK Inhibitor ONC201|Given orally
15750746|NCT04854044|Radiation|Radiation Therapy|Undergo radiation therapy
15750747|NCT04854044|Procedure|Resection|Undergo surgical resection
15750748|NCT04854031|Device|Cochlear Implants|Individuals with cochlear implants will be tested on their hearing ability. Auditory recordings of speech will be played to participants from a loudspeaker. Recordings will be edited to add competing noise sources and to adjust talker voice pitch. Synthetic sounds will be manipulated to control auditory cue salience in detection tasks.
15750749|NCT04854018|Drug|Indocyanine green|Intravenous or intraparenchymal injection
15750750|NCT04854005|Procedure|Breast-conserving surgery|Patients will undergo SLNB with dual-tracer mapping with technetium-99m sulfur colloid and lymphazurin blue dye, in accordance with routine clinical practice.
15750753|NCT04853979|Other|PRONE POSITION|Any combination of prone or side position for 3 hours, 3 times a day for 3 days
15750754|NCT04853966|Behavioral|Physical activity counseling|Physical activity counseling will be performed using physical activity behavior steps of the transtheoretical model.
15750755|NCT04853953|Other|Incidence of bleeding complications in ARDS patients on veno-venous ECMO|All bleeding complications (especially cerebral bleedings) will be analyzed in the study groups. At the bleeding event, laboratory parameters of coagulation will be collected and the intensity of the ECMO treatment
15750756|NCT04853940|Other|Data collection and clinical testing of subjects|6-months follow-up with clinical testing at 3 and 6 months
15750757|NCT04853927|Drug|Proxalutamide|Proxalutamide 300mg q.d suspension
15750758|NCT04853927|Drug|Placebo|Proxalutamide 300mg q.d placebo
15750759|NCT04853914|Device|HIFU treatment|HIFU treatment of Benign Prostatic Hyperplasia
15750760|NCT04853901|Drug|Remdesivir|Remdesivir loading dose of 200 mg intravenously followed by 100 mg/day intravenously for 5 to 10days
15750761|NCT04853901|Drug|Standard of care_1|Hydroxycoloroquine 400mg twice on day 1 then 200mg tab twice 2-10 days
15750762|NCT04853901|Drug|Standard of care_2|Methylprednisolone 1-2mg/kg for 5-7 days
15750763|NCT04853888|Behavioral|ATTACH™ Parenting Program|"ATTACH™ parenting program offers an innovative, novel approach to early intervention, focusing on improving parent-child relationship quality by targeting parents' underlying reflective function (RF)-the ability to better understand one's own and one's child's thoughts and feelings. RF is essential for high quality parent-child relationships and secure parent-child attachment, both tied to child development and health, especially cognition, communication and inflammation.
~."
15750769|NCT04853823|Drug|PDC-APB|PDC-APB Intra-muscular Injection
15750770|NCT04853823|Other|Placebo|Vehicle
15750771|NCT04853810|Other|CUTADIAB questionnaire|During a regular diabetes follow-up consultation, the patient is asked to complete the CUTADIAB questionnaire on a tablet, entirely dedicated to the study
15750772|NCT04853797|Drug|Ivabradine|To investigate the role of ivabradine on levcromakalim-induced migraine in patients with migraine without aura.
15750773|NCT04853797|Drug|Calcium|To investigate the role of calcium on levcromakalim-induced migraine in patients with migraine without aura.
15750774|NCT04853784|Procedure|intracorporeal anastomosis|intracorporeal anastomosis
15750775|NCT04853771|Behavioral|progressive muscle relaxation exercise training|Progressive muscle relaxation exercises (PKGE); 16 large muscles (right hand and forearm, right upper arm, left hand and forearm of left arm, left upper arm, forehead, upper cheek and nose, chin, neck, abdomen, upper right arm, which people can do on their own after learning) leg, right calf, right foot, left upper leg, left thigh and left foot), followed by the contraction and then relaxation and accompanied by deep breathing, is a preferred method for reducing pain, anxiety and depression in individuals.The relaxation will be required to take 10-20 before stretching the next muscle group. In this way, the muscle groups in the hands, arms, neck, shoulder, chest, abdomen, hips, feet and fingers, face and the whole body will be voluntarily stretched and relaxed, and pregnant women will be relieved.
15750776|NCT04853758|Drug|Sacubitril / Valsartan Oral Tablet [Entresto]|100 consecutive participants randomized independently at the Heart Institute - School of Medicine of the University of São Paulo (InCor),will receive sacubitril/valsartan for 6 months.
15750777|NCT04853758|Drug|Enalapril|100 consecutive participants randomized independently at the Heart Institute - School of Medicine of the University of São Paulo (InCor),will receive enalapril for 6 months.
15750778|NCT04853745|Device|AIR-FLOW® Master Piezon|AIR-FLOW® Master Piezon is intended for use in the cleaning and polishing of teeth by the projection of water,air, and dental powders onto the tooth surface. The device removes dental plaque, soft deposits, and surface stains from pits, grooves, interproximal spaces, or smooth surfaces of teeth. This air polishing device was used for all powder instrumentations.
15750779|NCT04853719|Drug|Rivaroxaban 2.5 Mg Oral Tablet|oral anticoagulants plus antiplatelet agent
15750780|NCT04853706|Diagnostic Test|3d cam|The 3D-CAM is a short interview that uses verbal responses and allows completion of the Confusion Assessment Method (CAM) diagnostic algorithm
15750781|NCT04853706|Diagnostic Test|DSM 5|The DSM-5 is the gold standard for diagnosing delirium. But proper use requires professional psychiatric background and training.
15750782|NCT04853693|Behavioral|Mom´s Supporting Mom|A preventive peer consultation intervention for Postpartum Depression.
15750783|NCT04853693|Behavioral|Enhanced Treatment As Usual|Referral to treatment in the community, clinical monitoring
15750784|NCT04853680|Device|Anti-adhesion barrier (Collarbarrier)|Collagen derived anti-adhesion barrier
15750785|NCT04853667|Other|Interview|Semi-structured interview, lasting a maximum of one hour
15750786|NCT04853654|Other|exercise|exercise training for 8 weeks
15750787|NCT04853641|Procedure|Cadaveric|Cadaveric Organ Transplant
15750788|NCT04853641|Procedure|Living Donor|Living Donor Organ Transplant
15750789|NCT04853628|Behavioral|Alerta Alcohol|The intervention consists of preventive messages about the benefits of not consuming alcohol, reducing the positive attitudes and encouraging the negative attitudes towards alcohol drinking and BD, as well as social influence and self-efficacy, by personalized feedback. Skills and action plans are encouraged to help the student to reject BD. This information is presented through different tailored text messages. Moreover, several gamification strategies are used (i.e. offering a challenge, giving different stories and the use of avatars in these stories that take place in three different scenarios: at home, at celebrations and in public places).
15750790|NCT04853628|Behavioral|Alerta Alcohol 2.0|The intervention consists of preventive messages about the benefits of not consuming alcohol, reducing the positive attitudes and encouraging the negative attitudes towards alcohol drinking and BD, as well as social influence and self-efficacy, by personalized feedback. Skills and action plans are encouraged to help the student to reject BD. This information is presented through different animated videos. Moreover, new gamification strategies are added (i.e. giving rewards and allocating points that can be accumulated and shown in a progress ranking) to those already used in Alerta Alcohol.
15750791|NCT04853615|Drug|Empagliflozin 25 MG|PAtient will receive empagliflozin 25 mg daily
15750792|NCT04853602|Biological|IFx-Hu2.0|"The investigational drug product IFx-Hu2.0 is composed of the drug substance pAc/emm55 (pDNA) complexed with the two excipients in vivo-jetPEI® (linear polyethylenimine), a transfection reagent, and dextrose, a pDNA/polyethylenimine complex stabilizer.
~Therapeutic Classification:
~Immunomodulatory Agent
~Route of Administration:
~Intralesional (i.e. injection of cutaneous, subcutaneous or nodal lesions)
~Mechanism of Action:
~Injection of IFx-Hu2.0 into the lesion facilitates the expression of the immunogenic Emm55 protein by the tumor cells.
~Physiological Effect:
~Expression of the emm55 gene by the tumor cells triggers immune recognition of tumor-specific and -associated antigens which leads to innate and adaptive immune responses. In addition to priming anti-tumor immunity in immune checkpoint inhibitor (ICI)-naïve patients, this could re-sensitize patients with primary or secondary ICI clinical resistance."
15750793|NCT04853589|Device|Hyaluronic acid gel|After the local anesthesia is injected, alveolar curettage is performed, and the socket is rinsed with saline solution. Prior to wound closure, patients from the test group 1 will receive hyaluronic acid gel.
15750794|NCT04853589|Device|Hyaluronic acid gel + carrier|After the local anesthesia is injected, alveolar curettage is performed, and the socket is rinsed with saline solution. Prior to wound closure, patients from the test group 2 will receive hyaluronic acid gel together with a collagen carrier.
15750796|NCT04853563|Other|PEEP|High PEEP targeted to 10 cmH2O to be maintained during the period of mechanical ventilation compared with low PEEP maintaining 3-5 cmH2O
15750797|NCT04853550|Device|Strattice Mesh|Subjects will be restrospectively identified has having undergone ventral hernia repair with Strattice mesh reinforcement. Once identified long term follow-up data will be collected.
15750833|NCT04853238|Other|Prospective observational cohort study|Prospective observational cohort study
15750798|NCT04853537|Dietary Supplement|intermittent fasting diet|intermittent fasting diet to obese pregnant women >30 BMI and incidence of gestational diabetes
15750799|NCT04853524|Drug|JNJ-56136379|JNJ-56136379 tablets will be administered orally.
15750800|NCT04853524|Drug|Bictegravir (BIC) plus Emtricitabine (FTC) plus Tenofovir Alafenamide (TAF)|A combination of BIC, FTC and TAF will be administered orally.
15750801|NCT04853511|Device|OCT-FLIM (optical coherence tomography-fluorescence life time)|comprehensive assessment of coronary plaque with OCT-FLIM dual modal intravascular catheter imaging followed by serial 18F-FDG-PET/CT imaging
15750802|NCT04853498|Drug|TQB3720|This is an androgen receptor antagonists.
15750803|NCT04853485|Device|repetitive transcranial magnetic stimulation (rTMS)|All subjects with early psychosis will be divided into three subgroups determined by their psychotic symptoms and cognition. There are three rTMS strategies: (1) For subgroup 1, characterized by negative symptoms, iTBS over cerebellum and 1 Hz over right DLPFC; (2) For subgroup 2, characterized by cognition deficits, 20 Hz over the left inferior parietal cortex; (3) For subgroup 3, characterized by positive symptoms: 10 Hz over ACC.
15750804|NCT04853459|Procedure|Border modeling..Measurement|By using light cure to make border modeling in complete denture.
15750805|NCT04853446|Drug|Dexamethasone 12 mg|One capsule of 12 mg of dexamethasone will be administered and one capsule of placebo.
15750806|NCT04853446|Drug|Placebo|Two capsules of placebo (glucosemonohydrate) will be administered.
15750807|NCT04853446|Drug|Dexamethasone 24 mg|Two capsules of 12 mg of dexamethasone will be administered.
15750808|NCT04853433|Other|Radiation therapy of unresected keloids|radiation therapy (RT) for the treatment of unresected keloids. The primary endpoint will be toxicity within 10 weeks of follow-up. Secondary endpoints will include cessation of growth or shrinkage of keloids, symptomatic response, and impact on quality of life.
15750809|NCT04853407|Drug|LY03005 extended-release tablet|orally once a day
15750810|NCT04853407|Drug|Placebo|orally once a day
15750813|NCT04853381|Other|dietary treatment (low FODMAP)|The aim of the study will be explained to the patients and the dietary treatment that will be recommended if they participate in the study will be told that they should be followed for 4 weeks. In addition, it will be notified that surveys will be conducted at the beginning and end of the 4-week period.
15750814|NCT04853381|Other|dietary treatment (gluten free)|The aim of the study will be explained to the patients and the dietary treatment that will be recommended if they participate in the study will be told that they should be followed for 4 weeks. In addition, it will be notified that surveys will be conducted at the beginning and end of the 4-week period.
15750815|NCT04853381|Other|dietary treatment (low FODMAP+gluten free)|The aim of the study will be explained to the patients and the dietary treatment that will be recommended if they participate in the study will be told that they should be followed for 4 weeks. In addition, it will be notified that surveys will be conducted at the beginning and end of the 4-week period.
15750816|NCT04853381|Other|dietary treatment (Traditional diet recommendations)|The aim of the study will be explained to the patients and the dietary treatment that will be recommended if they participate in the study will be told that they should be followed for 4 weeks. In addition, it will be notified that surveys will be conducted at the beginning and end of the 4-week period.
15750821|NCT04853355|Drug|Spironolactone 50 mg|Add Spironolactone 50 mg to previous regimen
15750822|NCT04853342|Drug|Drug: Furmonertinib 80 mg|The initial dose of Furmonertinib 80 mg once daily
15750823|NCT04853342|Drug|Furmonertinib 80 mg placebo|The initial dose of Furmonertinib 80 mg once daily
15750824|NCT04853329|Drug|CPO107|CD20-CD47 Bispecific Fusion Protein
15750825|NCT04853303|Device|Hypnosis VR|Children will be required to wear a VR gadget for hypnosis when they are experiencing chemotherapy-induced nausea and vomiting, sleep quality or pain. The duration is 15 minutes.
15750826|NCT04853290|Device|Ultrasound-guided peripheral venipuncture|Ultrasound-guided peripheral venipuncture performed by a proficient vascular access registered nurse. The procedure will be performed according to the standard operational protocol for ultrasound guided peripheral venipuncture instituted at the hospital where the study will be conducted. Site Rite 8 or Site Rite 5 ultrasound machines (Bard Access Systems, Inc., USA) will be used on the procedures.
15750827|NCT04853290|Device|Conventional peripheral venipuncture|Conventional peripheral venipuncture performed by the registered nurse at the clinical inpatient unit. The procedure will be performed according to the standard operational protocol for peripheral venipuncture protocol instituted in the hospital where the study will be conducted
15750828|NCT04853277|Behavioral|Education|Each Patient will undergo a 30 minute telephone visit with a trained Medical Provider outlining the timeline of various common emotional challenges experienced after transplant/CAR-T, as well as coping techniques. A pamphlet with information discussed will also be provided to the patient to review on their own time. The patient will have an opportunity to express any psychosocial/emotional concerns at this time.
15750829|NCT04853264|Device|Ultrasound-guided peripheral venipuncture|Ultrasound-guided peripheral venipuncture performed by a proficient vascular access registered nurse. The procedure will be performed according to the standard operational protocol for ultrasound guided peripheral venipuncture instituted at the hospital where the study will be conducted. Site Rite 8 or Site Rite 5 ultrasound machines (Bard Access Systems, Inc., USA) will be used on the procedures.
15750830|NCT04853264|Device|Conventional peripheral venipuncture|Conventional peripheral venipuncture performed by a registered nurse at the clinical inpatient unit. The procedure will be performed according to the standard operational protocol for peripheral venipuncture instituted in the hospital where the study will be conducted.
15750831|NCT04853251|Drug|Port Delivery System with Ranibizumab|The ranibizumab 100 mg/mL will be administered to participants via the PDS implant
15750832|NCT04853251|Drug|Intravitreal Ranibizumab Injection|Ranibizumab (intravitreal 0.5-mg injections of 10 mg/mL formulation) will be used in the study eye as supplemental treatment. If a study patient discontinues study treatment, he/she may start receiving intravitreal ranibizumab injections in the study eye, per investigator's discretion.
15750836|NCT04853199|Drug|Quercetin|Each patient should receive one tablet twice a day 30 minutes before the meal
15750837|NCT04853199|Drug|Placebo|Each placebo capsule contains 150 mg of microcrystalline cellulose and 1.5 mg of magnesium stearate.
15750838|NCT04853173|Other|Assess pain management modalities in adult outpatient tonsillectomy surgery|use a post-operative analgesia protocol suitable for outpatient surgery. Namely a protocol of analgesia based on the taking of drugs per bone (by mouth) and not intravenous. Pain evaluation.
15750839|NCT04853147|Drug|palonosteron, dexamethasone, and fosaprepitant dissolved in 0.9% NaCl|palonosteron 0.075 mg, iv, dexamethasone 5mg, iv, fosaprepitant 150mg dissovled in 0.9% NaCl 150ml, iv.drip,
15750840|NCT04853147|Drug|palonosteron, dexamethasone, and 0.9% NaCl|palonosteron 0.075 mg, iv, dexamethasone 5mg, iv, 0.9% NaCl 150ml, iv.drip,
15750841|NCT04853134|Drug|Proxalutamide|200 mg q.d.
15750842|NCT04853134|Other|Standard of Care|Standard of care as determined by the PI
15750843|NCT04853121|Procedure|Tapered Implants|Tapered Implants are placed in fresh socket via dynamic navigation
15750844|NCT04853121|Procedure|Straight Implants|Straight Implants are placed in fresh socket via dynamic navigation
15750845|NCT04853108|Other|Remote Monitoring of COVID-19|Remote monitoring of acute COVID-19 illness included use of a Medtronic pulse oximeter, photoplethysmography (PPG), patient-reported symptoms data, static vital signs captured during the course of the clinical evaluation and various physiomarkers.
15750846|NCT04853095|Procedure|Peritoneal fixation (PerFix)|PerFix involves suturing the free end of the peritoneal flap left after RARP + ePLND to the pelvic wall near the symphysis of the pubic bones leaving two lateral openings for directing the lymphatic fluid out of the pelvis to the abdominal cavity.
15750847|NCT04853095|Procedure|Standard of care|ePLND without peritoneal flap fixation
15750848|NCT04853082|Drug|Limonene capsule|All the recruiters will be given treatment under the guidance of basic diet. Basic dietary guidelines include high-quality protein and fresh green leafy vegetables. It need to controlled sugar, various sweets and high-calorie foods, frying and other foods with high oil content and foods with high cholesterol content. Limonene capsules group and placebo group were used for treatment. The random number is generated by the central randomization system. All the recruiters were divided into placebo control group and limonene capsule administration group. The numbers will be assigned according to random numbers. In this study, qualified subjects were randomly assigned to the treatment group and the placebo control group at a ratio of 1:1. The drug was administered for 12 weeks, 3 times a day, 5 capsules each time.
15750849|NCT04853082|Drug|Limonene capsules(Placebo)|Limonene capsules(Placebo)
15750850|NCT04853069|Drug|Transdermal estradiol gel|Patients will receive standard care +/- (randomsed 1:1) transdermal 17ß-estradiol gel (3 mg; applied to forearm, upper arm and shoulder) for ten days.
15750851|NCT04853056|Device|virtual reality|wearing virtual reality glasses
15750852|NCT04853056|Device|Cold vibration|Buzzy
15750853|NCT04853043|Drug|Cetuximab|Cetuximab will be administered every 2 weeks. The initial dose of 500 mg/m2 is to be administered by IV infusion over 120 minutes on the first day of the treatment. In the absence of infusion reactions, subsequent doses are to be administered over 60 minutes biweekly. Each cycle will be defined as 14 days of treatment.
15750854|NCT04853030|Drug|Fiasp|Advanced closed-loop insulin therapy with Faster acting insulin Aspart (Fiasp)
15750855|NCT04853030|Drug|Novorapid|Advanced closed-loop insulin therapy with Standard acting insulin Aspart (Novorapid
15750858|NCT04852991|Procedure|Modified Purandare cervicopexy|The modified Purandare's cervicopexy will be performed in low lithotomy position . Pfannenstiel incision was utilized and the abdomen was opened in layers maintaining perfect hemostasis. Uterus will be delivered through the incision and held with uterus holding forceps. The bladder was dissected inferiorly. A 25-30 cm long strip of polypropylene mesh was prepared by soaking. The mesh was fixed anteriorly at the level of isthmus by No.1 polypropylene sutures . The ends of the mesh were brought lateral to rectus muscle retroperitoneally on both sides taking care not to injure the inferior epigastric vessels. After confirming the correct fixation and haemostasis the uterovesical fold of peritoneum was approximated. The ends of the mesh were fixed to the rectus muscle by criss crossing using No. 1 polypropylene sutures. After confirming the haemostasis, the abdomen was closed in layers. Per speculum examination was done to note the reduction of prolapse.
15750859|NCT04852991|Procedure|Abdominal sacral hysteropexy|After peritoneal entry through pfannenstiel incision was, the bladder is mobilized off the cervix. Windows are made in the broad ligament at the level of the isthmus. Posteriorly, the rectovaginal space is entered at the level of the uterosacral ligaments. Next, a 15x15-cm polypropylene mesh is used to fashion two 4.5- to 5-cm-wide strips of mesh; one is bisected for a distance of 5 cm to produce a Y-configuration for the anterior mesh.The anterior mesh arms are passed through the broad ligament windows and attached to the cervix and pubocervical fascia using interrupted 2-0 PDS. The posterior mesh is attached to the rectovaginal fascia using transverse-interrupted 2-0 PDS sutures. Once the sacral dissection has exposed the anterior longitudinal ligament, the proximal ends of the 2 mesh strips are attached to the sacral promontory using two 2-0 polyester sutures to provide elevation of the uterus without tension. The peritoneum is closed over the mesh using a 3-0 vicryl suture
15750896|NCT04852588|Procedure|Endobronchial ultrasound-guided transbronchial fine needle aspiration (EBUS-TFNA)|Chest lymph node sampling procedure by EBUS
15750897|NCT04852588|Procedure|Transesophageal ultrasound-guided fine needle aspiration (EUS-FNA)|Chest lymph node sampling procedure by EUS
15750898|NCT04852562|Procedure|Modified radical endoscopic sinus surgery|Modified radical endoscopic sinus surgery was performed to remove the mucosa including ethmoid sinus and maxillary sinus, as well as a completly middle turbinate.
15750862|NCT04852939|Other|Bowen's technique|"Initially, cup move is performed which requires a vertically rolling Bowen move over the posterior border of the deltoid muscle above the axillary crease.
~The subject's arm is held flexed at 90 degrees at mid-chest height. Then, the elbow is slowly and passively moved in the direction of the opposite shoulder.
~After maximal adduction of the arm, the therapist firmly taps the lateral aspect of the shoulder with the heel of his/her hand.
~The arm is then carried back to the original start position, where the therapist gently moves superiorly and slightly laterally over the anterior fibers of the deltoid. The arm is then carefully lowered.
~The therapist strives to undertake a minimum of moves and procedures to trigger the body's own self-healing powers and assess how much pressure to use and where and when to perform a move to release the build-up of stress.
~40-minute sessions thrice a week for 6 weeks."
15750863|NCT04852939|Other|Conventional physical therapy|"Hot pack and transcutaneous electrical nerve stimulator (TENS) for 15 minutes.
~Pendulum stretch, 10 revolutions.
~Cross body stretch, 4 repetitions.
~Towel stretch/hand behind the back, 4 repetitions.
~Isometric internal and external rotation exercises. 40-minute sessions thrice a week for 6 weeks."
15750864|NCT04852926|Other|Self-administered questionnaires|"6 self-administered questionnaires (EORTC-QLQ-C30, RSE, BIS, HAD, FSFI, DAS-4) completed by the patients at every usual follow-up consultation.
~1 (FSFI) or 2 (MSHQ, PEP) self-administered questionnaires completed by the partner (respectively female or male) between every usual follow-up consultation.
~Follow-up usual consultations :
~T0 (at inclusion) : before disease + since diagnosis
~C4 (chemotherapy course n°4)
~C6 (chemotherapy course n°6)
~M3 (3 months after chemotherapy)
~M6 (6 months after chemotherapy)
~A1 (1 year after chemotherapy)
~A2 (2 years after chemotherapy)"
15750865|NCT04852913|Other|Bowen's Technique|The thumb of the therapist was placed on the top of the targeted muscle (upper trapezius, levator scapulae, tight pectoralis and sternocleidomastoid, longissimus capitis, splenius capitis cervical multifidus). The skin was carried away gently from the spine without disturbing the muscle. The thumb was then hooked into the lateral aspect of the muscle to form a pressure on the muscle. Then the thumb was flattened in the medial direction, when this happened the muscle would plop or 15 respond in some way. Heating pad + TENS will be given The session lasted for 20 minutes 3sessions/week for 6th week
15750866|NCT04852913|Other|Convention Physical Therapy|"Myofascial Release + Active Range of Motion Deep transverse friction was given for 10 minutes followed by myofascial stretching of muscle for 3 times, each holding for 90 seconds. Then myofascial release was given using ulnar border of both palms of the therapist.
~Active range of motion exercises will be given 10 reps with 5 seconds hold. Heating pad + Transcutaneous Electrical Nerve Stimulator (TENS) will be given The session lasted for 20 minutes 3sessions/week for 6th week"
15750867|NCT04852900|Other|Decompression with 30%|"Hot Pack for 10 mins Soft Tissue Mobilization
~Muscle Strengthening
~Decompression with 30% The total time for the session will be 45 minutes and there will be 03 sessions/week for 6 weeks"
15750868|NCT04852900|Other|Decompression with 40%|"Hot Pack for 10 mins Soft Tissue Mobilization
~Muscle Strengthening
~Decompression with 30% The total time for the session will be 45 minutes and there will be 03 sessions/week for 6 weeks"
15750869|NCT04852900|Other|Decompression with 50%|"Hot Pack for 10 mins Soft Tissue Mobilization
~Muscle Strengthening
~Decompression with 30% The total time for the session will be 45 minutes and there will be 03 sessions/week for 6 weeks"
15750870|NCT04852887|Other|Radiation and Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)|"Post lumpectomy radiation therapy will be external beam radiation to either the whole breast + boost, partial breast irradiation, or Accelerated Partial Breast Irradiation that must begin within 12 weeks of the last breast cancer surgery(including re-excision of margins).
~Endocrine therapy for a minimum of 5 years. The specific regimen of endocrine therapy is at the treating physician's discretion. The dose and schedule of the drug(s) used for endocrine therapy should be consistent with the instructions in the drug package insert(s). Endocrine therapy may be initiated before, during, or after completion of radiation therapy at the discretion of the investigator."
15750871|NCT04852887|Drug|Endocrine Therapy (Tamoxifen, Anastrozol, Letrozole, Exemestane)|Endocrine therapy for a minimum of 5 years. The specific regimen of endocrine therapy is at the treating physician's discretion. The dose and schedule of the drug(s) used for endocrine therapy should be consistent with the instructions in the drug package insert(s).
15750872|NCT04852874|Procedure|Ultrasound-guided Quadratus Lumborum Block|"Low dose spinal anesthesia will be done at L3-4 lumbar vertebrae with bupivacaine 2.5 mg (0.5 ml Marcaine 0.5%) and fentanyl 25 µgm (0.5 ml) of fentanyl amp (100 µgm/ 2ml) to be added to 1.5 - 2 ml of free water to form total volume of 2.5- 3ml according to the patient height aiming level of T6 sensory level.
~Quadratus lumorum block:
~After 4 to 5 minutes, ultrasound guided quadratus lumborum block (QL 1,2,3) will be done unilaterally, using low-frequency convex probe, taking into consideration the total volume of injectate not exceeding 0.4 ml /kg of (bupivacaine 0.5%) to avoid local anesthesia systemic toxicity. This is equal to 0.8 ml/kg of (bupivacaine 0.25%).
~After confirming the correct position of the needle, 0.2-3 ml/kg of 0.25% bupivacaine plus 1.5 mg dexamethasone and magnesium sulphate of 100 mg will be injected in each site of the QL 1,2,3 using the lean body weight. The lean body weight will be calculated by omni lean body mass online calculator."
15750874|NCT04852848|Behavioral|Connect2Test Intervention|Brief assessment based feedback and motivational interviewing intervention
15750877|NCT04852809|Other|No intervention|This is an observational study
15750878|NCT04852796|Other|Patients with hemopathy|optimal humoral response at 1 month after COVID-19 vaccination
15750879|NCT04852783|Device|Contour Neurovascular System|Endovascular embolization of wide-necked, bifurcated saccular intracranial aneurysms.
15750899|NCT04852562|Procedure|functional endoscopic sinus surgery|Full maxillary antrostomy, ethmoidectomy, sphenoidotomy and frontal sinusotomy, but with the middle turbinate preservation.
15750924|NCT04852315|Dietary Supplement|Placebo|Gelatine capsule with placebo (Cellulose; Guinama, Valencia, Spain). The capsule containing the treatment was ingested with 150 mL of water 60 minutes before the onset of the experiment to allow substance absorption.
15750990|NCT04851782|Device|ivEAD tubing kit|ivEAD tubing designed to reduce infusion pump alarms do to air in infusion line
15791676|NCT04519385|Drug|Dexamethasone|dexamethsone pulse therapy
15750880|NCT04852770|Behavioral|Trial-Based Cognitive Therapy|TBCT is an approach that includes psychoeducation and cognitive restructuring techniques concerning automatic thoughts, underlying assumptions and core beliefs related to the traumatic events. It is conducted in a therapeutic setting that makes use of experiential techniques, allowing the patient to refer to him/herself in the third person and thus taking distance from him or herself. One of TBCT techniques for dealing with guilt and shame, emotions that provoke great limitation to patients with PTSD, is the participation grid (PG). Another important technique is the consensual role-play (CRP), designed to help patients resolve ambivalence and make decisions. In addition, the most important TBCT technique, the Trial, was developed to help patients change dysfunctional negative core beliefs. Therapists who will conduct this approach have a specialization level in CBT. In this study, this treatment will be delivered in 14 sessions, weekly, individualy, one session by week and on line.
15750881|NCT04852770|Behavioral|Mindfulness-Based Health Promotion|"The MBHP protocol is a structured program developed over 8 sessions, in group, where participants (8-15 people) meet every week for 2 hours (standard duration of one session), to experience the concepts and techniques of mindfulness. Participants are also given suggestions of daily activities to be implemented at home or in the workplace, that last in average 15-20 minutes, but may last up to 45 minutes in the case of more motivated and compliant participants. They are also encouraged to incorporate the idea of Mindfulness in their daily lives (the so-called informal practice), so that all daily activities somehow become opportunities to practice Mindfulness. In this study, this treatment will be delivered in 14 sessions, weekly, individualy, one session by week and on line."
15750882|NCT04852770|Behavioral|Positive psychotherapy|PPT is the clinical and therapeutic work derived from PP. PPT consists of 15 specific practices that have been empirically validated, either separately, or in conjunction with two or three practices. After empirical validation, these practices were organized in a cohesive protocol of 15 sessions called PPT. Many of these practices have been studied through online interventions. In the present study, the protocol will be reduced to 14 sessions, with sessions called positive relationships, positive communication, and practical wisdom removed. It was understood that the other 12 would be more easily adapted to the moment of the study. (DUCKWORTH; STEEN; SELIGMAN, 2005; MONGRAIN; ANSELMO-MATTHEWS, 2012; RASHID; SELIGMAN, 2019). In this study, this treatment will be delivered in 14 sessions, weekly, individualy, one session by week and on line.
15750883|NCT04852744|Other|Brain MRI|"Anatomical MRI The anatomical data will be acquired by means of a 3T Signa Premier General Electric Healthcare MRI, allowing the acquisition of classic anatomical sequences (T1, T2) and a high-resolution hippocampal sequence allowing to accurately apprehend its various sub-fields. (total acquisition time: 10 min).
~The hippocampal volume, the orbital-frontal cortex and the cingulate cortex will be measured by voxel-based morphometry (VBM; Ashburner & Friston, 2000]) using the SPM software (Statistical Parametric Mapping; Friston et al., 2006). The voxel-by-voxel morphometric analysis of T1 MRI images makes it possible to classify and segment the different brain tissues (gray matter versus white matter) and to analyze the focal differences in volume within these tissues between the different groups."
15750884|NCT04852731|Procedure|Cardiac MRI|Injected cardiac MRI
15750885|NCT04852731|Other|Blood collection|Blood collection (including genetics at the inclusion visit)
15750886|NCT04852731|Procedure|Prolongation of the MRI examination|Prolongation of the MRI examination (4D flow sequence ; about 10 min)
15750887|NCT04852705|Biological|SARS-CoV-2 Vaccine (Vero Cells), Inactivated|2 doses of SARS-CoV-2 Vaccine (Vero Cells), Inactivated should be administered as an intramuscular injection into the lateral deltoid of the upper arm with a 28-day interval.
15750888|NCT04852705|Biological|Placebo|2 doses of Placebo should be administered as an intramuscular injection into the lateral deltoid of the upper arm with a 28-day interval.
15750889|NCT04852679|Drug|Lanreotide autogel|Administered as deep subcutaneous (SC) injections
15750890|NCT04852653|Procedure|Supplementary blood samples collection during the normal follow up of the patients|Supplementary blood samples collection during the normal follow up of the patients
15750891|NCT04852640|Procedure|Active Rehabilitation Program (ARP)|The ARP intervention consists of therapeutic exercises designed to increase shoulder strength and endurance using a cluster of common exercises used for the treatment of shoulder pain. Specifically, the ARP program will focus on increasing scapular motor-control through a phasic program of common therapeutic exercises. This concept has been shown in the literature as capable of reducing shoulder pain and improving function in a variety of pathological conditions, however, the effect of this approach to reducing pain and increasing function for symptomatic shoulder instability is unknown. The selection of exercises and application for each exercise included in the ARP is based on recommendations from the literature and will incorporate participant feedback to customize dosages.
15750892|NCT04852640|Procedure|Nonspecific Passive Intervention (NPI)|The NPI intervention consists of a non-specific treatment approach to shoulder pain that is commonly administered in the clinical setting. Specifically, passive modalities such as ultrasound, massage, and sensory electric stimulation are commonly prescribed in the treatment of shoulder pain to modulate pain. Further, general core strengthening exercises are often implemented. Therefore, the NPI will consist of regularly prescribed passive treatments and general core strengthening exercises, as commonly administered in routine treatment of shoulder pain.
15750893|NCT04852627|Behavioral|Brisk walking|Walking
15750894|NCT04852614|Diagnostic Test|Pharmacokinetic test|Blood samples will be collected 48 hours after the first dose on day 3 of the observed intake of the study medication at the following time points: t=0 (pre-dose), 1, 2, 3, 4, 8 and 12 hours post ingestion (7 samples) (3 mL each), Breast milk samples will be collected by emptying both breasts at 0, 2, 4, 8 and 12 hours (5 samples).
15750895|NCT04852601|Other|ToolboxDetect|The clinician or staff member will identify the patient by either scanning a barcode or entering his/her name, age and medical record number on an administrative screen (allowing for proper routing of test results). After completing the test, a 'submit' button will automatically generate a secure HL7 message, sharing 1) a binary classification of the results ('impaired cognition' or 'normal function'), 2) the quantitative ToolboxDetect score, and 3) brief clinical decision support to rule out any reversible causes. These results will be linked to a discrete, queriable, Epic SmartData element. As patients undergo multiple AWVs over time, ToolboxDetect quantitative scores will be displayed in Epic Synopsis Activity, a graphical display that can visualize trend data (e.g. patient vitals) and calculate a percentage change from the prior year. This will allow a clinician to establish a patient's own baseline (instead of using normative data only) for reference.
15750900|NCT04852549|Other|Oculomotor exercise|"While holding the head in the middle position, holding two colored objects in both hands, looking at the object in the right hand without turning the head, counting up to 10 and looking at the object in the left hand and counting up to 10,
~While holding a fixed head in the middle position and holding a colored object in the right hand, following the object with the eyes while moving the right hand from right to left without turning the head and returning,
~With the head fixed in the middle position, with the right hand on the left, eyes are fixed on the hand-held colored object and turn the head to the right and left.
~The head will be fixed in the middle position, the eyes will be fixed on the colored object held in the right or left hand and the arm and the head will be turned to opposite directions."
15750901|NCT04852536|Device|Neurostimulation (High Definition - transcranial Direct Current Stimulation) HD-tDCS|5 consecutive sessions lasting 20 minutes of HD-tDCS4x1, based on previous publications (VILLAMAR et al., 2013). A list will be provided current of 2 mA, placing a central electrode (anode) on the M1 contralateral to the painful limb and the four return electrodes within a radius of 7.5 cm around, corresponding approximately to Cz, F3, T7 and P3 if the stimulation is on the side left, and Cz, F4, T8 and P4 if it is on the right, according to the International 10/20 System.
15750902|NCT04852523|Drug|18F-fluciclovine|18F-Fluciclovine is a synthetic L-leucine amino acid used clinically for PET imaging in patients with biochemical recurrence of prostate cancer following definitive therapy. The pancreas accumulates striking amounts of Axumin, where it is considered a normal finding. Pancreatic beta-cell function may be slow to recover following pancreatic transplantation and may vary as a function of perioperative steroid administration, acute rejection, inadequate islet cell transplantation, allograft pancreatitis or compromised blood supply. Viability of the allograft is a common clinical concern and is difficult to assess based on insulin, C-peptide, and blood sugar levels. Rapid identification of compromised allograft viability is critical in the management of these patients.
15750903|NCT04852510|Drug|Metformin Versus a combination of Metformin and Thymoquinone (TQ)|Patients were divided into two groups (A and B) using a computer-based software Open Epi version 3.21. Patients in Group A, received Metformin 500 mg three times daily (5) with meals for 6 months (Metfor® 500 mg, Metformin hydrochloride tablets. TABUK Pharmaceutical. KSA). Patients in Group B, received a combination of Metformin 500 mg three times daily with meals (Metfor® 500 mg, Metformin hydrochloride tablets. TABUK Pharmaceutical. KSA) and Thymoquinone (TQ) in the form of Black Cumin oil (Cumin Mar® Black cumin oil 500 mg soft gel capsules, MARNYS. Spain) three times daily before meals for 6 months.
15750904|NCT04852497|Procedure|Ventricular tachycardia ablation|patients having undergone ventricular tachycardia radiofrequency ablation using of pace mapping strategy to identify the critical isthmus
15750905|NCT04852484|Drug|local anesthetic-morphine|Before the operation, 19 mL of 0.5% Ropivacaine + 2 mg of morphine (20 mL in total) will be injected in the paravertebral space. Afterwards, there will be a pump of 500 ml of 0.2 % ropivacaine + 6 mg of morphine connected to the catheter after the end of the surgery, administered continuously at a rate of 10 mL/hr
15750906|NCT04852484|Drug|local anesthetic-ketamine|Before the operation, 19 mL of 0.5% Ropivacaine + 50 mg of ketamine (20 mL in total) will be injected in the paravertebral space. Afterwards, there will be a pump of 500 ml of 0.2 % ropivacaine + 200 mg of ketamine connected to the catheter after the end of the surgery, administered continuously at a rate of 10 mL/hr
15750907|NCT04852484|Drug|local anesthetic|Before the operation, 19 mL of 0.5% Ropivacaine + 1 mL of normal saline (20 mL in total) will be injected in the paravertebral space. Afterwards, there will be a pump of 500 ml of 0.2 % ropivacaine connected to the catheter after the end of the surgery, administered continuously at a rate of 10 mL/hr
15750908|NCT04852471|Behavioral|Standard Post-Operative Counseling + FACT-G|Counseling at discharge + FACT-G at enrollment, at 15-18 and at 30-32 days post-operative.
15750909|NCT04852471|Behavioral|PROM symptom tracker|A 12-item symptom tracker adopted from the Patient Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (NCI-PRO-CTCAE), delivered via text, on days 4, 6, 8, 12, 18, 24, and 30 post surgery.
15750910|NCT04852458|Drug|Intravenous (IV) hydrocortisone|"Participants (20) will be given IV hydrocortisone within 6-12 hours of the traumatic event.
~90 - 150 mg. of intravenous hydrocortisone dosing regimen based on participant weight: 90mg will be administrated to participants weighing 45-59kg. 100mg will be administrated to participants weighing 60-69kg. 120mg will be administrated to participants weighing 70-89kg. 140mg will be administrated to participants weighing 90-99kg. 150mg will be administrated to participants weighing 100-120kg."
15750911|NCT04852432|Device|high flow nasal cannula|The heated air is administered at a rate of 2L/kg/min using an Optiflow device (Fisher and Paykel Healthcare, Auckland, New Zealand). Inhalation oxygen concentration starts with 50%.
15750912|NCT04852432|Device|nasal prong|Oxygen is administered via nasal prong
15750913|NCT04852419|Drug|ZN-c5|ZN-c5
15750914|NCT04852406|Drug|Protocol-based management of perioperative antithrombotic therapy|Perioperative antithrombotic therapy is managed according to the latest expert consensus published in the Chinese Medical Journal, 2020.
15750915|NCT04852406|Drug|Routine management of perioperative antithrombotic therapy|Perioperative antithrombotic therapy is managed according to current routine practice.
15750916|NCT04852393|Procedure|Block|cervical medial branch block
15750917|NCT04852380|Procedure|PRP injections|The 5 mL PRP concentrate was injected every week for three times, starting from recruitment. The patient was placed supine whit a knee flexion of 90°.All the procedures were carried out in an aseptic condition, injected in the knee soft spot through an anterior approach, using a 21-gauge needle.
15750918|NCT04852367|Device|Focused Ultrasound|Focused ultrasound targetting the tumour at subablative powers, to facilitate drug release
15750919|NCT04852367|Drug|Doxorubicin|Doxorubicin infusion
15750920|NCT04852367|Drug|ThermoDox|ThermoDox infusion
15750921|NCT04852341|Device|Collect ocular biological parameters including age, corneal diameter, eye axis, intraocular pressure, steep&flat axis of corneal curvature, corneal thickness, lens thickness, anterior chamber depth|observation
15750923|NCT04852315|Dietary Supplement|Caffeine|Gelatine capsule with caffeine (3 mg/kg body mass of caffeine) (Bulk Powders, London, United Kingdom). The capsule containing the treatment was ingested with 150 mL of water 60 minutes before the onset of the experiment to allow substance absorption.
15792149|NCT04515628|Drug|Branebrutinib|Specified dose on specified days
15750926|NCT04852263|Other|Group I|Oral fiberoptic intubation was carried out using lingual traction without nasopharyngeal airway.
15750927|NCT04852263|Other|Group II (NPA group)|Oral fiberoptic intubation was carried out using lingual traction plus modified nasopharyngeal airway.
15750928|NCT04852250|Other|Virtual centralized multidisciplinary tumour board|Evaluation of radiologic imaging and general condition by a multidisciplinary expert gremium to recommend either secondary intervention or resection of metastases or continuation of systemic treatment
15750930|NCT04852211|Procedure|Open or laparoscopic surgery|"Patients, with their consent, will be recruited to participate by investigators after considering the inclusion and exclusion criteria. Treatment allocation to the eligible patients will follow a randomization schedule. A total of 212 subjects will be randomized 1:1 to one of the two treatment arms:
~Laparoscopic group: LMH
~Open group: OMH"
15750931|NCT04852198|Procedure|OAGB|Simplified gastric bypass procedure
15750932|NCT04852198|Procedure|RYGB|Roux-en-Y gastric bypass. Standard procedure in the Netherlands
15750933|NCT04852185|Biological|Vi-TT|Single-dose V-TT administered to children and adolescents between the ages of 9 months to 15 years.
15750934|NCT04852185|Biological|MCV-A vaccine|Single-dose of MCV-A vaccine (a meningococcal vaccine)
15750935|NCT04852172|Drug|L-citrulline|L-citrulline is a naturally occurring amino acid. It is produced by, and normally present in, the human body.
15750936|NCT04852172|Other|Normal saline (0.9% NaCl) D5 ½|Saline
15750937|NCT04852146|Procedure|Electronic feedback|Feedbacks have been identified as one of the most effective interventions to improve practices and organisations in health care institutions. It is also a tool for facilitating and coordinating practice registers, improving the contribution of data producers and the quality of data.
15750939|NCT04852120|Other|No intervention|Compound Sodium Picosulfate Granules administered by the patient prior to X-ray examination, endoscopy or surgery when judged clinically necessary in accordance to usual practice consistent with the local prescribing information.
15750940|NCT04852107|Other|Spinal Cord Stimulation, association of both (DUAL), Dorsal Root Ganglion stimulation|"Lead Implantation which will be conducted in 2 steps:
~Lead implantation: 8-contact SCS percutaneous lead on SC and 8-contact lead on DRG.
~Neurostimulation trial phase (Mode DUAL). IPG implantation + Randomization + 1st leads programming (SC, DRG or DUAL stimulation according to randomization sequence).
~2nd leads programming (SC, DRG or DUAL stimulation according to randomization sequence). 3rd leads programming (SC, DRG or DUAL stimulation according to randomization sequence). All patients will be switched to Burst waveform for a 1- month follow-up period while keeping the last allocated stimulation type in the randomized crossover arm."
15750941|NCT04852094|Other|Qualitative focus group|A qualitative focus group is performed with staff members and parents of hospitalised newborns in a NICU during Family-centered rounds management. The transcribed interviews are analyzed with qualitative content analysis in order to illuminate the experience, feelings and thoughts arisen among the staff members and the parents.
15750942|NCT04852081|Drug|Palbociclib|Palbociclib is in the form of oral capsules. Palbociclib, capsule, 125 mg taken orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days. Palbociclib should be taken with food
15750943|NCT04852081|Drug|Ribociclib|Ribociclib, tablets, 600mg orally (three 200 mg tablets)taken once daily with or without food for 21 consecutive days followed by 7 days off treatment
15750944|NCT04852081|Drug|Abemaciclib|Abemaciclib in combination with fulvestrant or an aromatase inhibitor: 150 mg twice daily Abemaciclib as monotherapy: 200 mg twice daily. (2.1)
15750945|NCT04852081|Drug|Letrozole|Letrozole will be dosed daily at a fixed dose of 2.5 mg/day throughout the study.
15750946|NCT04852081|Drug|Anastrozole|Anastrozole will be dosed daily at a fixed dose of 1 mg/day throughout the study.
15750947|NCT04852081|Drug|Tamoxifen|Tamoxifen will be dosed daily at a fixed dose of 20 mg/day throughout the study.
15750948|NCT04852081|Drug|Fulvestrant|Fulvestrant is in the form of a prefilled syringe containing 5 ml of an injection solution of 250 mg of fulvestrant for intramuscular injection. The recommended dose is once every 28 days, once at a dose of 500 mg, and on the 15th day after the initial injection, a loading dose of fulvestrant 500 mg is added.
15750949|NCT04852081|Drug|Exemestane|Exemestane will be dosed daily at a fixed dose of 25mg/day throughout the study.
15750950|NCT04852081|Drug|Alpelisib|Alpelisib will be dosed daily at a fixed dose of 300 mg/day throughout the study.
15750951|NCT04852068|Biological|Freeze-dried human rabies vaccine (Vero cells) Zhifeilongkoma - 5-dose program|Inoculate 1 dose of Investigational vaccine each on 0, 3, 7, 14, 28 days, by intramuscular injection of deltoid muscle of upper arm
15750952|NCT04852068|Biological|Freeze-dried human rabies vaccine (Vero cells) Zhifeilongkoma - 4-dose program|Inoculate 1 dose of Investigational vaccine each on both arms on day 0, and 1 dose each on day 7 and 21, by intramuscular injection of deltoid muscle of upper arm
15750953|NCT04852068|Biological|Freeze-dried human rabies vaccine (Vero cells) Chengda - 5-dose program|Inoculate 1 dose of control vaccine each on 0, 3, 7, 14, 28 days, by intramuscular injection of deltoid muscle of upper arm
15750954|NCT04852068|Biological|Freeze-dried human rabies vaccine (Vero cells) Chengda - 4-dose program|Inoculate 1 dose of control vaccine each on both arms on day 0, and 1 dose each on day 7 and 21, by intramuscular injection of deltoid muscle of upper arm
15750955|NCT04852055|Behavioral|Advance Care Planning Video|Clinical assistants determine who is the correct person to receive the informational materials. If the patient is the correct recipient, clinicians will send the informational materials to the patient at the assisted living center. If the proxy is the correct recipient, the clinical assistant will determine whether or not the proxy is using the existing online portal. If the proxy is using the portal, the informational materials will be sent electronically. If the proxy does not access the portal, the informational materials will be sent to their residences.
15751804|NCT04845009|Behavioral|progressive muscle relaxation|progressive muscle relaxation
15750956|NCT04852055|Behavioral|Advance Care Planning Video and Conversation|The same process will be used to send materials through the portal as described in the Information Only arm. For the follow-up discussion, clinicians will speak to either the patient or the proxy (or both). Clinicians will receive basic advance care planning training and a structured conversation guide to facilitate these conversations.
15750957|NCT04852042|Behavioral|mHealth|Participants will receive 2-3 text messages daily. The messages will include information to promote healthy eating and physical activity.
15750958|NCT04852042|Behavioral|CHW support|The CHW will provide behavioral counseling to participants guided by a study website related to their healthy eating and physical activity goals.
15750959|NCT04852029|Other|Low dose hCG|Patients will either maintain the current dose of have an increased dose prescribed based on randomization
15750960|NCT04852016|Behavioral|Consent process with the addition of Digital educational platform (DEP)|In-patients being consented for laparoscopic cholecystectomy will be provided with a Digital Educational Platform (DEP), in the form of modules on an iPad. These participants will still undergo the usual standard verbal consent (SVC). Multiple choice questionnaires will be given pre and post consent to determine acquisition and retention of the information provided using DEP.
15750961|NCT04852016|Behavioral|Consent process using the standard verbal consent (SVC)|In-patients being consented for laparoscopic cholecystectomy will go through the SVC. Multiple choice questionnaires will be given pre and post consent to determine acquisition and retention of the information provided using SVC.
15750962|NCT04852003|Drug|SHR0410 Injection|SHR0410 Injection
15750963|NCT04852003|Drug|Placebo|Placebo for SHR0410 Injection
15750964|NCT04852003|Drug|Morphine|Morphine
15750965|NCT04851990|Other|To Better Days Large Patch|Large patch containing vitamin D & Dextrose for transdermal absorption
15750966|NCT04851990|Other|To Better Days Small Patch|Small patch containing vitamin D & Dextrose for transdermal absorption
15750967|NCT04851977|Biological|Respiratory Syncytial Vaccine|BARS13 low dose (one dose of 10 μg rRSV-G protein/10 μg CsA by IM injection to the deltoid region of one arm, and one dose of placebo [saline/mannitol] by IM injection to the deltoid region of the other arm, given sequentially).
15750968|NCT04851977|Biological|Respiratory Syncytial Vaccine|BARS13 high dose (IM injection of 10 μg rRSV-G protein/10 μg CsA administered to the deltoid region of each arm [one injection of 10 μg rRSV-G protein/10 μg CsA per arm], given sequentially). The high dose is twice the strength of the low dose.
15750969|NCT04851977|Biological|Placebo|Placebo (IM injection of saline/mannitol administered to the deltoid region of each arm [one injection per arm], given sequentially).
15750970|NCT04851964|Biological|Experimental: Tezepelumab|Tezepelumab subcutaneous injection
15750971|NCT04851964|Other|Placebo|Placebo subcutaneous injection
15750972|NCT04851951|Procedure|one-shot PRP injection|A single injection of PRP (7% concentrate) ml 4 was made in the Supraspinatus tendon and in the Subacromial space under ultrasound guidance.
15750973|NCT04851938|Device|transcutaneous electrical nerve stimulation device|The application of transcutaneous electrical nerve stimulation is a nonpharmacological method that midwives can apply and determining the effect on these factors will be a guide for the future applications.
15750974|NCT04851925|Other|MR Fingerprinting|Specific Magnetic Resonance Imaging protocol
15750975|NCT04851912|Other|Winterlight Apps|Longitudinal speech recordings
15750976|NCT04851899|Dietary Supplement|Phaeosol low dose|"1 Phaeosol softgel of 500mg/day (containing 218mg/d of active ingredients) and 1 placebo softgel of 500mg/day (218mg of sunflower oil -look like softgel of Phaeosol product) + 1 Guarana capsule of 500mg/day (Organic guarana extract containing 8-11% of native cafeine).
~Subjects were instructed to take the study supplement or placebo once daily for 1 months (±2 days). The first and the last doses will be administered at the clinical site during Visit 2 (Experiment 1) and Visit 3 (Experiment 2, respectively)."
15750977|NCT04851899|Dietary Supplement|Phaeosol high dose|2 Phaeosol softgels of 500mg/day (each containing 218mg of active ingredients) + 1 Guarana capsule of 500mg/day (Organic guarana extract containing 8-11% of native cafeine). Subjects were instructed to take the study supplement or placebo once daily for 1 months (±2 days). The first and the last doses will be administered at the clinical site during Visit 2 (Experiment 1) and Visit 3 (Experiment 2, respectively).
15750978|NCT04851899|Dietary Supplement|Placebo|2 placebo softgels of 500mg/day (each 218mg of sunflower oil -look like softgel of Phaeosol product) + 1 capsule of 500mg/day containing Microcellulose (look like capsule of guarana). Subjects were instructed to take the study supplement or placebo once daily for 1 months (±2 days). The first and the last doses will be administered at the clinical site during Visit 2 (Experiment 1) and Visit 3 (Experiment 2, respectively).
15750979|NCT04851886|Device|BURT|Robot-assisted upper-limb individual (i.e. one-on-one) rehabilitation will be delivered using the BURT system by Barrett Technology
15750980|NCT04851886|Device|BURT + PostureCheck|Robot-assisted upper-limb group (i.e. up to three subjects) rehabilitation will be delivered using the BURT system by Barrett Technology + PostureChek (a camera-based system to track the quality of the exercises)
15750982|NCT04851860|Drug|sublingual immunotherapy|sublingual immunotherapy is the only disease modifying therapy preventing the evolution of AR to asthma
15750983|NCT04851847|Device|Guided Tissue Regeneration (GTR)|Use of resorbable collagen membrane to treat periodontal intrabony defects.
15750984|NCT04851834|Drug|NTX-301|Oral hypomethylating agent
15750985|NCT04851834|Drug|Platinum-based Chemotherapy|Standard of care for ovarian and bladder cancer
15750986|NCT04851834|Drug|Temozolomide|Standard of care for high-grade glioma
15750987|NCT04851821|Drug|Quercetin|Each patient included, after signing the consent, will have a treatment for ten days: one tablet times three per day 30 minutes before the meal.
15750988|NCT04851795|Other|supervised physical exercise sessions|Participants assigned to the supervised exercise group will perform a supervised routine of approximately 30 minutes, 2 days per week (Monday and Wednesday at the Txagorritxu hospital, and Tuesday and Thursday at the Santiago hospital from 7:15 to 7:45 and from 15:15 to 15:45).
15750989|NCT04851795|Other|unsupervised physical exercise|For the non-supervised group, we will propose climbing the stairs from floor 0 to floor 7 three times during the working day and doing planks and stretching exercises outside of work. For the latter, an educational session will be given at the beginning of the study to explain how to perform them correctly.
15750991|NCT04851769|Drug|PCSK9 inhibitor plus statin|Patients in the alirocumab arm will receive alirocumab 75 mg Q2W added to statin therapy (atorvastatin 20 mg/day or rosuvastatin 10mg/day).
15750992|NCT04851769|Drug|standard statin therapy|Patients will continue to receive atorvastatin 20 mg/day or rosuvastatin 10 mg/day.
15750993|NCT04851769|Procedure|Coronary imaging follow-up|coronary angiography and OCT imaging at week 36 ± 2 weeks follow-up
15750994|NCT04851756|Device|CRet|In prone position, subjects will get a 7 min preparation massage with CRet on resistive mode (80-100W), on the lumbar area, followed by a 5 min preparation massage with CRet on resistive mode (100-120 W) on the hamstrings. Then a 5 min Functional Massage (F.M) with passive anckle dorsiflexion and CRet on resistive mode (110-120 W) will be performed on the gastrocnemius medialis and lateralis, followed by a 4 min F.M with CRet on capacitive mode (180-250VA) on the mentioned area. In supine position, a 5 min F.M with passive knee flexion and CRet on resistive mode (110-140W) will be performed on the rectus femoris, followed by a 4 min F.M with passive knee flexion and CRet on capacitive mode (180-250VA) on the mentioned area. A physiotherapist will monitor the temperature of the patient's treated area every 2 minutes.
15750995|NCT04851756|Device|Sham CRet|"In prone position, subjects will get a 7 min preparation massage with CRet on resistive mode (0 W), on the lumbar area, followed by a 5 min preparation massage with CRet on resistive mode (0 W) on the hamstrings. Then a 5 min Functional Massage (F.M) with passive anckle dorsiflexion and CRet on resistive mode (0 W) will be performed on the gastrocnemius medialis and lateralis, followed by a 4 min FM with CRet on capacitive mode (0 VA) on the mentioned area. In supine position, a 5 min F.M with passive knee flexion and CRet on resistive mode (0W) will be performed on the rectus femoris, followed by a 4 min F.M with passive knee flexion and CRet on capacitive mode (0VA) on the mentioned area.
~A physiotherapist will monitor the temperature of the patient's treated area every 2 minutes."
15750996|NCT04851743|Other|Dry needling|The experimental extremity will received a single treatment session of TrP dry needling as follows: the therapist will located the TrP and will applied manual compression until the participant will reported pain. After that, dry needling technique will be performed on the TrPs for 60 seconds.
15750997|NCT04851730|Procedure|Orthopedic Physical Therapy Intervention|"First, a deep slow breathing protocol is intended to increase the expansion of the pelvic floor, utilizing the relationship between the diaphragm and the pelvic floor, resulting in a gentle stretching of the pelvic floor.
~Next, abdominal soft tissue mobilization, or scar mobilization of the lumbopelvic abdominal area will take place.
~Next, manual therapy to the thoracic or lumbar spine or the hips will be performed based on the impairments found in the orthopedic evaluation.
~The participant will be given a home exercise program to support breath training, and manual therapy. During the initiation of the second visit each participant will watch a standardized pain education video on the tablet, Understanding pain in less than 5 minutes and what to do about it The above plan of care will be completed 2 times/week for 4 weeks for a total of 8 visits."
15750998|NCT04851730|Device|Dry Needling|"Third, the investigator will dry needle appropriate muscles. Dry needling treatment technique will include insertion of a sterile, disposable, solid filament needle into the muscle belly in the area palpated as listed below. A 0.30 × 0.50mm, or specified size below, stainless steel Seirin J-type or Myotech needle will be used (Dommerholt 2011). Clean technique will be employed throughout the treatment procedure which includes hand washing, clean latex-free glove use, and skin-surface preparation with an alcohol swab ( Baima & Isaac 2008). Each muscle will receive a maximal number of 2 insertions and each insertion consists of up to 5 seconds of a pistoning (in and out motion) technique in an attempt to elicit a local twitch response. Standard protocol for each muscle will be established prior to beginning data collection.
~Details about the dry needling protocol can be found in Appendix L."
15750999|NCT04851717|Drug|Remimazolam|Remimazolam for intravenous sedation
15751000|NCT04851704|Behavioral|Tuning in to Kids|A parenting program that includes 6 group supervisions of parents, where emotion coaching and promotion of kids emotional competence are main focus.
15751001|NCT04851691|Behavioral|EHR CDS|"When a clinician initiates a new antipsychotic prescription for a patient with dementia, a three-pronged electronic health record clinical decision support tool pops up: (1) Alerting clinicians that antipsychotic prescriptions increase patient mortality; (2) Offering non-pharmacological behavioral resources for caregivers via a link to the IDEA! strategy resources on how caregivers can best manage a patient's behavioral disturbance non-pharmacologically, which will be available in the EHR to include in the patient's after visit summary; and (3) Defaulting prescriptions to a low supply of pills in to order to minimize harm. In addition, the PI will email all providers randomized to the intervention arm in order to make them aware of the components of this intervention and its motivation."
15751002|NCT04851691|Other|Usual Care|Patients will receive usual care from their physicians.
15751003|NCT04851678|Other|None - observational study|None - observational study
15751004|NCT04851665|Other|No Intervention - this was a qualitative analysis|No Intervention - this was a qualitative analysis
15751005|NCT04851652|Other|No intervention nor exposure|As an observational study, no intervention nor exposure is interested.
15751006|NCT04851639|Other|Wolverhampton Assessment Tool|a proxy means for assessing whether clinician intervention is required and to assess patient's lived quality of life
15751007|NCT04851626|Other|Hypnotic intervention for persistent pelvic pain.|Education about persistent pelvic pain followed by 7 recordings of hypnosis intervention across 7 weeks accessed online through recordings.
15751008|NCT04851626|Other|Control group persistent pelvic pain no intervention.|Control group no hypnotic intervention. Waitlist control.
15751009|NCT04851613|Drug|Afuresertib|The starting doses of the combination therapy are afuresertib 125 mg PO, QD plus fulvestrant 500 mg IM, D1, 15 in the first cycle and afuresertib 125 mg PO, QD plus fulvestrant 500 mg IM, D1 Q4W in the subsequent cycles
15751010|NCT04851600|Device|prosthesis|Casting and delivery of a cosmetic upper limb prosthesis at 3-4 months old of age.
15751011|NCT04851587|Behavioral|In-Person (or Remote) Intervention|Participants will be asked to engage in self-administered activities during the intervention including pleasant activity scheduling, values clarification, mindfulness practice, goal setting, standard pain coping skills, and weight management including nutrition education and physical activity monitoring.
15751012|NCT04851574|Drug|Sugammadex Injection|Sugammadex was administered in the dose of 0.5 Mg/kg or 1.0 Mg/kg or 2.0 Mg/kg to reverse neuromuscular blockade.
15751051|NCT04851288|Dietary Supplement|Placebo|Each placebo capsule contains inert excipient and is identical in appearance
15751013|NCT04851561|Diagnostic Test|Cardiopulmonary stress test (CPET)|Cardiopulmonary stress test will be conducted under the guidance of sports and exercise physicians and nursing staff. Electrocardiogram, spirometry, blood pressure and gas exchange measuring will be assessed at rest. The participants will then undergo CPET according to a modified Astrand treadmill test protocol. The test will be terminated at maximal exercise or upon the appearance of limiting symptoms. Continuous electrocardiogram and repeated blood pressure measuring will be conducted at the recovery phase. Post-exercise spirometry will also be assessed.
15751014|NCT04851548|Procedure|hyaluronic acid|after flap refection, the furcation area will be debrided then add hyaluronic acid 8% and cover it with a collagen membrane
15751015|NCT04851535|Drug|Jaktinib Hydrochloride Tablets|Jaktinib 100mg Bid
15751016|NCT04851522|Drug|Di-Dak-Sol|Topical solution applied externally.
15751017|NCT04851522|Other|White Petrolatum|Topical ointment applied externally
15751018|NCT04851509|Procedure|Dynamic Rotational Locking|Performed, as per the Synthes technique guide, using the 5mm hex flexible set screwdriver and then loosening the set screw by one-half turn of the screwdriver.
15751019|NCT04851509|Procedure|Static Locking|Performed by using the torque-limiting set screwdriver and locking the set screw down onto the helical screw to prevent dynamic sliding of the helical screw within the nail.
15751022|NCT04851457|Drug|Intravenous tirofiban combination therapy|Patients will enter the tirofiban treatment protocol immediately within half an hour after randomization and prior to the femoral artery puncture. Tirofiban is administered as an intravenous bolus dose of 10 μg/kg injection within 3 min and then by an intravenous infusion at a rate of 0.1 μg/(kg·min) for 24 hours.
15751023|NCT04851444|Drug|SI-F019|Single dose is administered IV.
15751024|NCT04851431|Behavioral|one-to-one peer mentoring|Weekly meetings with a peer family caregiver
15751025|NCT04851418|Device|Possible NSTE-ACS|As mentioned in the group description
15751026|NCT04851405|Behavioral|Physiotherapist counselling + Fitbit and OEP app|"PTs will receive OEP and BAP training. They will provide at home visits and follow-up phone calls to the older adult participants (5 at home visits and 9 follow-up phone calls).
~Older adults will have access to the OEP app and a Fitbit."
15751027|NCT04851405|Behavioral|Physiotherapist counselling + Fitbit|"PTs will receive BAP training. They will provide at home visits and follow-up phone calls to the older adult participants (5 at home visits and 3 follow-up phone calls).
~Older Adults will receive 6 follow-up phone calls from research staff
~Older adults will have access to a Fitbit"
15751028|NCT04851392|Drug|Cannabis with delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)|Cannabis with delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) - inhaled and vaporised cannabis flower
15751029|NCT04851392|Drug|Cannabis with THC without CBD|Cannabis with THC without CBD - inhaled and vaporised cannabis flower
15751030|NCT04851392|Drug|Placebo cannabis|Placebo cannabis, without THC and without CBD - inhaled and vaporised
15751031|NCT04851366|Behavioral|PROCARE+ (with add-on modules)|The modules will mainly consist in therapy sessions to provide the adolescents with tools to confront risk situations such as communication skills, coping skills to manage stress, etc. The group will include education about discussing thoughts, feelings, and behaviour as parts of emotion, and emphasis on providing support around the specific risks factors detected.
15751032|NCT04851366|Behavioral|PROCARE (UP-A for selective purposes)|This core intervention is meant to respond to the heterogeneity inherent in emotional difficulties presentation by extinguishing distress associated with the presentation of heightened negative emotion in general and reduction or elimination of resultant emotionally-driven behaviours, including avoidance, escape, aggression, and controlling behaviours (e.g., reassurance seeking) that reinforce emotional distress intensity over time.
15751033|NCT04851366|Behavioral|Active control condition|Psychoeducation about many different emotions, emphasis on discussing thoughts, feelings, and behavior as parts of emotion, and emphasis on providing support around generally distressing events.
15751034|NCT04851353|Behavioral|GT+VC|Gentle touch and verbal comfort,
15751035|NCT04851353|Behavioral|Smell|Smell breast milk
15751036|NCT04851353|Behavioral|Taste|Taste breast milk
15751037|NCT04851340|Other|Cow's Milk|Participants will consume 200 mL, 300 mL, and 400 mL of 1% bovine milk during the diet challenge which occurs on three consecutive days of the study. The first day of the diet challenge participants consume 200 mL, the second day 300 mL and the third day 400 mL.
15751038|NCT04851340|Other|Soy Milk|Participants will consume 200 mL, 300 mL, and 400 mL of soy milk during the diet challenge which occurs on three consecutive days of the study. The first day of the diet challenge participants consume 200 mL, the second day 300 mL and the third day 400 mL.
15751039|NCT04851327|Behavioral|High Energy preload|Tests the extent to which participants reduce their intake at a meal following ingestion of a high energy preload drink
15751040|NCT04851327|Behavioral|Low energy preload|Tests the amount participants eat at a meal following ingestion of a low energy preload drink
15751041|NCT04851327|Behavioral|Test meal|Test meal to follow low or high energy preload
15751042|NCT04851314|Device|ICU certified ventilator|Examine anesthetic consumption rates
15751043|NCT04851314|Device|Non-ICU certified ventilator|Examine anesthetic consumption rates
15751044|NCT04851301|Behavioral|Active Virtual Reality|Participants will be assigned to an immersive VR environment.
15751045|NCT04851301|Behavioral|sham Virtual Reality|Participants will be assigned to a sham VR environment without the immersive experience.
15751046|NCT04851301|Other|No Intervention|Participants will experience tonic pain tolerance tests without exposure to any environments.
15751047|NCT04851301|Drug|Naloxone|"4mg of Naloxone will be administered (0.1 mL of 40 mg/ml naloxone solution given intranasally).
~A random allocation sequence will be independently generated by the UM Pharmacy. The Principal investigator will call for each experiment."
15751048|NCT04851301|Other|Saline|"Intranasal Normal Saline (0.1 mL 0.9% sodium chloride) will be administered shortly before beginning the fMRI experiment.
~A random allocation sequence will be independently generated by the UM Pharmacy. The Principal investigator will call for each experiment."
15751049|NCT04851301|Other|Natural history|Participants will not be provided Naloxone or Saline.
15751050|NCT04851288|Dietary Supplement|MitoQ|MitoQ is a biochemically modified form of ubiquinol
15751052|NCT04851275|Behavioral|Physicians trained in shared decision making|Physicians in this group were trained in shared decision making
15751053|NCT04851275|Behavioral|Physicians were not trained in shared decision making|Physicians did not receive training in shared decision making
15751054|NCT04851262|Behavioral|Exercise|The intervention is to be taught by fitness trainer at the participants' home at the start of each phase. The exercise progression model for older adults recommended by the American College of Sports Medicine, which emphasise gradual increments in training load and systematically alter one or more programme components, will be adopted.
15751055|NCT04851249|Procedure|Hallux Valgus - chevron osteotomy, lapidus procedure|The purpose is to compare the preoperative clinical features (previous medical history, age, BMI, occupational status etc), PROMs (Manchester-Oxford Foot and ankle questionnaire, SF-36, VAS activity scale) and radiological parameters (both two and three dimensional) with the postoperative PROMs (+ likert scale) and the postoperative radiological parameters.
15751056|NCT04851236|Other|Massage|Massage administered at regular intervals.
15751057|NCT04851210|Other|No intervention|No intervention
15751058|NCT04851197|Other|Flipped Learning Model|Students in the intervention group will be given training on testicular cancer and testicular self-examination in accordance with the Flipped Learning Model. The students in the control group will receive the same training with the traditional method. It was aimed to examine the effect of the training given with the Flipped Learning Model on the students' knowledge levels and health beliefs about testicular cancer and self-testicular examination.
15751059|NCT04851184|Device|Gaze stabilization Exercises using Virtual Reality Device|Participants will utilize a wireless virtual reality headset to perform their gaze stabilization exercises to better control the background and visual field as well as collect data related to speed, excursion, and duration of head movements.
15751060|NCT04851184|Behavioral|Gaze stabilization non-instrumented|Participants will perform gaze stabilization exercises in a non-instrumented manner. Subjects are instructed to focus on a letter on a piece of paper held at arm's length. They are instructed to move their head back and forth as quickly as they can while keeping the letter in focus. The total duration of the exercise (from 10 - 240 seconds) and background complexity (simple to complex moving) are increased gradually according to patient symptoms.
15751061|NCT04851171|Procedure|Flexible Ureteroscopy|Flexible ureteroscopy is the use of flexible ureteroscope for the treatment of stone in the upper ureter with the aid of laser lithotripsy.
15751062|NCT04851171|Procedure|Semi-rigid Ureteroscopy|Semi-rigid ureteroscopy is the use of the semi-rigid ureteroscope for the treatment of stone in the upper ureter with the aid of laser lithotripsy.
15751063|NCT04851158|Device|Effectiveness of ShotBlocker on the perceived pain and satisfaction during intramuscular antibiotic injection|"Intervention: Verbal information was given to the participants prior to the intramuscular injection, and their written consents were obtained. The Structured Information Form consisting of five questions was applied by face-to-face interview method. Height and weight were measured, and BMI (kg/m2) was calculated and recorded in the Structured Information Form.
~Application: ShotBlocker will be used on 35 patients during intramuscular injection.
~Final assessment: VAS will be applied immediately after the intramuscular injection to determine the pain and satisfaction levels of the participants."
15751064|NCT04851158|Device|Effectiveness of local vibrator device on the perceived pain and satisfaction during intramuscular antibiotic injection|"Intervention: Verbal information was given to the participants prior to the intramuscular injection, and their written consents were obtained. The Structured Information Form consisting of five questions was applied by face-to-face interview method. Height and weight were measured, and BMI (kg/m2) was calculated and recorded in the Structured Information Form.
~Application: Local vibrator device will be used on 35 patients during intramuscular injection.
~Final assessment: VAS will be applied immediately after the intramuscular injection to determine the pain and satisfaction levels of the participants."
15751065|NCT04851145|Diagnostic Test|Mass spectrometry-based proteomics of FFPE biopsies and urine samples|"The biopsy and urine samples will be processed by the OncoProt platform (University of Bordeaux) for proteomic analysis by tandem mass spectrometry (label-free quantification) as follows:
~Biopsies: laser microdissection of the renal cortex, fixation reversion, protein extraction and electrophoretic migration, tryptic digestion.
~Urines: samples concentration by centrifugation/filtration and tryptic digestion according to a protocol adapted from the FASP method (Filter-Aided Sample Preparation)"
15751066|NCT04851132|Radiation|Radiotherapy|IMRT (Intensity Modulated RT) or 3D-CRT (three-dimensional conformal radiotherapy); 95% PGTV 59.92Gy/2.14Gy/28f; 95% GTVnd 59.92Gy/2.14Gy/28f; 95% PTV 50.40Gy/1.80Gy/28f; 5 days a week; 6 weeks.
15751067|NCT04851132|Drug|Durvalumab|Durvalumab 1000 mg, intravenously (IV), on Day 1 of radiotherapy, every 3 weeks for up to 18 administrations.
15751068|NCT04851119|Drug|Tegavivint|Given IV
15751069|NCT04851106|Diagnostic Test|Endoscopic ultrasound|Diagnosis of pancreatic adenocarcinoma with endoscopic ultrasound.
15751070|NCT04851093|Drug|TCM granule plus conventional drug|"All patients will receive conventional drug according to 2020 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Medicine Diagnosis Treatment Guidelines.
~Yiqiwenfei granule for qi deficiency and internal cold fluid syndrome.
~Fuzhengqinghua granule for qi and yin deficiency and unclean phlegm heat syndrome.
~Fuzhengzaohua granule for lung and spleen qi deficiency and phlegm-damp amassing in lung syndrome.
~TCM granule (Jiangyin Tian Jiang Pharmaceutical Co.,Ltd, 10g/packet) will be administered twice daily for 8 weeks."
15751071|NCT04851093|Drug|TCM placebo granule plus conventional drug|"All patients will receive conventional drug according to 2020 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Medicine Diagnosis Treatment Guidelines.
~Placebo Yiqiwenfei granule for qi deficiency and internal cold fluid syndrome.
~Placebo Fuzhengqinghua granule for qi and yin deficiency and unclean phlegm heat syndrome.
~Placebo Fuzhengzaohua granule for lung and spleen qi deficiency and phlegm-damp amassing in lung syndrome.
~TCM placebo granule (Jiangyin Tian Jiang Pharmaceutical Co.,Ltd, 10g/packet) will be administered twice daily for 8 weeks.
~The appearance, weight, color and odor of the preparation are the same as those of experimental group.
~The placebo granule consists of dextrin, bitter and 5% of the TCM granule."
15751160|NCT04850274|Behavioral|Remote Therapy Intervention (RTI)|A single ED session followed by 5 remote therapy sessions
15751161|NCT04850274|Behavioral|Artificial Intelligence Remote Therapy Intervention|Optimized by reinforcement learning to step up or down the intensity of treatment between three levels based on patient response to daily assessments.
15751072|NCT04851080|Device|Heart Rate Variability|"Heart rate variability is carried out using the complex of prenosological diagnostics VARICARD 2.51 with the ISCIM 6.2 program is methodically based on the technology of analysis of heart rate variability, it uses the original scientific and theoretical substantiation of HRV indicators, which is based on modern ideas about stress, functional state of the body and assessment of health levels. It is designed to assess the risk of developing diseases in persons who are in states bordering health and disease. A decrease in the adaptive capabilities of the organism is considered as the main risk factor, the results obtained with its help are considered from the point of view of the level of health or stressful effects. It can be successfully used to control the effectiveness of medical intervention. Functionally, the complex is designed to register an electrical signal and form conclusions about the functional state of the body, assess the level of stress and its effect on health."
15751073|NCT04851080|Device|Spirometry|Spirometry is carried out using the device Spirotest USPTs-01, equipped with liquid crystal indicators. It is non-invasive method for measuring air flows and volumes as a function of time using forced maneuvers. It is intended for functional diagnostics of the lungs, namely, indication and measurement of forced vital capacity and forced expiratory volume in the first second.
15751074|NCT04851080|Behavioral|Testing of psycho-physiological functions using four questionnaires|Research of the behavioral time preferences by Composite Scale of Morningness (CSM, Smith C.S., Reilly C., Midkiff K., 1989). Translation into Russian by Kolomeichuk S., May 2015), of the chronotype by Munich ChronoType Questionnaire (MCTQ, Roenneberg T., Merrow M., LMU München, 2006, 2008. Translation into Russian by Putilov A.A., Danilenko K.V., approved by the authors October 2007, updated 2010), of the seasonal pattern by Seasonal Pattern Assessment Questionnaire (SPAQ, Rosenthal N.E., Genhart M., Sack D.A., Skwerer R.G., Wehr T.A., 1987.Translation into Russian by Putilov A.A., Danilenko K.V., Korneeva N.I. 1988, 2002), of the sleep quality by Pittsburgh Sleep Quality Index (PSQI, Russian edition Semenova E.A., Danilenko K.V., October 2009)
15751075|NCT04851067|Other|Dry Needling and Therapeutic Exercises (DNTEx)|Already included in arm/group descriptions.
15751076|NCT04851067|Other|Manual Therapy and Therapeutic Exercises (MTTEx)|Already included in arm/group descriptions.
15751077|NCT04851054|Procedure|Surgery for colon cancer with intention to cure|Surgery by open or laparoscopic approach
15751078|NCT04851041|Other|Potato|Controlled human intervention trial to evaluate the impact of boiled potato intake as part of a healthy dietary patterns on cardiometabolic health
15751079|NCT04851041|Other|Pasta/rice|Since potatoes, white rice and white pasta are all products with a high glycemic index and concomitant relatively steep glucose excursions after intake, this intervention group helps to compare the effect of potato vs another high glucemic index food.
15751080|NCT04851028|Behavioral|Music Therapy|Music therapy is a non-pharmacological intervention, in which music and its elements are used professionally as an intervention in medical, educational, and everyday environments with individuals, groups, families, or communities who seek to optimize their quality of life and improve their physical, social, communicative, emotional, intellectual, and spiritual health and wellbeing. This therapy has shown to provide significant benefits for individuals with cognitive decline living in care homes, enhancing social-cognitive functions and reducing behavioural symptoms (Brotons & Koger, 2000; Hsu et al., 2015; Zhang et al., 2017).
15751081|NCT04851015|Drug|trimethoprim-sulfamethoxazole|10mg/kg/day of TMP component
15751082|NCT04851015|Drug|trimethoprim-sulfamethoxazole|15mg/kg/day of TMP component
15751083|NCT04851002|Procedure|Application of concentrated growth factor with dental implants|Concentrated growth factor(CGF) liquid applied to the implant cavity also CGF membrane covered socket and implant
15751084|NCT04851002|Procedure|Application of advanced platelet rich fibrin with dental implants|Advanced platelet rich fibrin (A-PRF) liquid applied to the implant cavity also A-PRF membrane covered socket and implant
15751085|NCT04851002|Procedure|Control side of concentrated growth factor study group|Traditional implant methods applied
15751086|NCT04851002|Procedure|Control side of advanced platelet rich fibrin study group|Traditional implant methods applied
15751087|NCT04850989|Device|Pico Goblin VR headset|We worked with Limbix to tailor content on a Pico Goblin VR headset by creating two exposure therapy themes (general social skills training/dinner party or job interview) based on CBT principles and literature. The Pico Goblin VR headset projected a 5.5-inch diagonal screen size (depth: 139.7 mm; height: 122mm; width: 68mm) with 2560 x 1440-pixel resolution, 3 degrees of freedom, 92° field of view, a refresh rate of 70Hz, and 54-71mm interpupillary distance (Kyoto, 2017). It was chosen because displays of the pre-recorded VRE videos could be smoothly operated wirelessly with a tablet that showed the selected scenes in real-time. Further, the headset could be conveniently switched on and off, and dovetailed the participant's head motion. These scenes were filmed with a 360° stereoscopic camera, each lasting between 1.5 to 10 min.
15751088|NCT04850976|Device|Endotracheal intubation|Every eligible patient was intubated using either SAM-VL or McGrath MAC® according to their randomization allocation
15751089|NCT04850963|Device|Transcranial direct current stimulation active|Transcranial direct current stimulation active
15751090|NCT04850963|Device|Transcranial direct current stimulation sham|Transcranial direct current stimulation sham
15751091|NCT04850950|Drug|Tenofovir Alafenamide fumarate 25mg Oral Tablet|Tenofovir alafenamide fumarate initiated from the late pregnancy to the delivery date or postpartum month 1.
15751092|NCT04850937|Drug|Esketamine|The experimental group will be given 0.25mg/kg esketamine slowly intravenously after anesthesia induction
15751093|NCT04850937|Drug|normal saline|The experimental group will be given 0.5ml/kg normal saline intravenously after anesthesia induction
15751094|NCT04850924|Other|evaluation psychological trauma|9 classes of symptoms to be evaluated
15751095|NCT04850911|Drug|Ketamine Hydrochloride|Ketamine is a high trapping NMDA receptor antagonist which has rapid and reliable antidepressant effects in patients with major depressive disorder (MDD) who have failed to respond to conventional monoaminergic agents.
15751096|NCT04850911|Other|No intervention (placebo)|Placebo injection (0.9% sodium chloride)
15751162|NCT04850261|Drug|hCG Injection|Ovulation will be induced by subcutaneous hCG injection
15751163|NCT04850261|Drug|Nafarelin nasal spray|Ovulation will be induced by nasal application of Nafarelin
15751805|NCT04845009|Behavioral|Usual care|Usual care
15751099|NCT04850885|Drug|inj dexamethasone 4mg/ml and inj lignocaine 20mg/ml|The modified technique of classical IANB was to be selected to avoid failure as described by Clark and Homes (1959). The patients were requested to keep their mouth wide open and an occlusal plane parallel to the floor. Palpation of anatomical landmarks was done properly and the guide finger was positioned at the retromolar fossa. A 5 ml syringe equipped with a 24 gauge needle length of 3.6 cm was used, it was been advanced from premolar on the opposite side into the tissue just above the fingernail until hitting the bone. The body of the syringe was redirected over the lower central incisors and kept parallel to the molars in a horizontal plane at the same time. The needle was inserted another 2 cm deep into the tissue and 3.5 ml of solution X was deposited 1 cm higher than the usual after multiple aspirations (90 degrees two planes). Further, 1 ml solution X was deposited after the withdrawn needle in pterygomandibular space.
15751100|NCT04850872|Behavioral|PLAYwithHEART Programme for adolescent athletes|PLAYwithHEART programme for adolescent athletes is an intervention programme based on Mindfulness, Acceptance, and Compassion for adolescent athletes
15751101|NCT04850859|Other|measure various dimensions of the glenoid|measurement of Superior-Inferior glenoid diameter ,Anterior-Posterior glenoid diameter and study shape of the glenoid cavity .
15751102|NCT04850859|Other|measure various dimensions of the acetabulum|measurement of transverse diameter of the acetabulum ,vertical diameter of the acetabulum, depth of the acetabulum ,Width of acetabular notch and study shape of anterior acetabular ridge and ends of lunate surface .
15751103|NCT04850846|Drug|Metformin XR|Orally by mouth
15751104|NCT04850846|Other|Placebo|Orally by mouth
15751105|NCT04850820|Dietary Supplement|Novel essential amino acid supplementation|This intervention will determine the impact of EAA+ on markers of whole-body net protein balance, protein synthesis, and protein breakdown following home-based resistance exercise in a free-living setting.
15751106|NCT04850820|Dietary Supplement|Branched-chain amino acid supplementation (BCAA)|This intervention will determine the impact of the BCAA supplement (to be compared to EAA+) on markers of whole-body net protein balance, protein synthesis, and protein breakdown following home-based resistance exercise in a free-living setting.
15751107|NCT04850820|Dietary Supplement|Isocaloric carbohydrate supplementation|This intervention will determine the impact of an isocaloric carbohydrate placebo supplement (to be compared to EAA+) on markers of whole-body net protein balance, protein synthesis, and protein breakdown following home-based resistance exercise in a free-living setting.
15751108|NCT04850807|Behavioral|Music & Memory|Music and Memory is a personalized music program in which caregivers (nursing home staff, family, or others) provide people with dementia with music playlists tailored to their personal history of music preferences at times when behaviors are likely
15751110|NCT04850781|Behavioral|Bi-weekly frozen meal home delivery|All participants randomized to this arm will receive 10 frozen meals that are mailed to their home every two weeks from a MOW vendor, TRIO foods.
15751111|NCT04850781|Behavioral|Daily home meal delivery|All participants randomized to this arm will receive meals delivered to their home multiple times per week from a MOW program employee/volunteer with a wellness check and socialization.
15751112|NCT04850768|Other|Saliva|"individuals' saliva samples will be collected and transferred to eppendorf tubes.
~Until biochemical analysis is carried out will be stored in -80ºC."
15751113|NCT04850768|Other|gingival crevicular fluid|GCF samples of individuals will be collected by paper strips and transferred to eppendorf tubes.Until biochemical analysis is carried out will be stored in -80ºC.
15751114|NCT04850755|Drug|Selinexor in combination with nivolumab and ipilimumab|Patients will commence at dose level 1. One cycle is 42 days (6 weeks) for all three agents. At dose level 1, selinexor will be dosedorally weekly, and nivolumab at 2 weekly + ipilimumab 1mg/kg 6 weekly. Patients can have dosing interruptions or reductions of any drug independently of one another, depending on the drug causing the toxicity
15751115|NCT04850742|Procedure|Cryopreserved aorta|After resection of the tracheal or bronchial lesion with standard surgical techniques, the airway gap is reconstructed with a segment of human cryopreserved (-80 celsius degree) aortic allograft, which was not matched by the ABO and leukocyte antigen systems. The anastomosis is performed with standard technique for airway anastomosis. An Ultraflex covered tracheobronchial stent is inserted to prevent collapse for the aortic graft.
15751116|NCT04850729|Other|non-intervention|non-intervention
15751117|NCT04850716|Other|non-intervention|non-intervention
15751118|NCT04850703|Device|Transcranial Radom Noise Stimulation|tRNS against Dapoxetine in LPE patients
15751119|NCT04850703|Drug|Take Dapoxetine|Dapoxetine against tRNS in LPE patients
15751120|NCT04850703|Combination Product|Comparation EEG changes between Sham Group against tRNS and Dapoxetin participants|Compare EEG parameters like Theta Rhythm and Coherence between three groups of participants: sham, tRNS participants and Dapoxetine participants groups.
15751121|NCT04850703|Diagnostic Test|Compare LPE EEG endophenotype between participants and healthy controls|Define as precisely as possible the electrophysiological endophenotype of Longlife Premature Ejaculation, using healthy humans who do not express the LPE EEG endophenotype
15751122|NCT04850690|Diagnostic Test|2D Gait analysis|"The gait with four different conditions (single gait, Cognitive Task, Motor Task and Cognitive Task&Motor Task) was evaluated by Kinovea video analysis method on a 10-meter course.
~Single: Walking without task at a self-selected speed
~Cognitive Task (CT): Walking while counting down rhythmically from 20 in threes
~Motor Task (MT): Walking while carrying an empty box
~CT + MT: Walking while carrying an empty box and counting down rhythmically from 20 in threes"
15751123|NCT04850677|Other|Observational Cohort|Observational study
15751124|NCT04850664|Drug|CBOT + TAU|The CBOT with proprietary odorant molecules is designed to stimulate olfactory neural activity over long periods of time. It is paired with OFC-dependent cognitive tasks.
15751125|NCT04850664|Drug|Sham + TAU|Sham CBOT device uses artificially scented compressed room air instead of olfactory stimulants and has control cognitive tasks.
15751164|NCT04850248|Other|no intervention, this is an observational study|no intervention, this is an observational study
15751165|NCT04850235|Drug|Nab paclitaxel|Nab paclitaxel plus cisplatin and capecitabine as neoadjuvant chemotherapy
15751923|NCT04844008|Dietary Supplement|Nanobubble drink|Commercially available sports drink
15751127|NCT04850638|Drug|SHR4640 tablets and furosemide tablets|SHR4640 tablets and furosemide tablets
15751128|NCT04850612|Other|Survey|Delphi Survey on core outcomes, CSDH definition and data elements
15751132|NCT04850586|Other|Education Group|The patients in the training group were given structured training by a multidisciplinary team. After the content of the structured education was prepared, three experts were consulted for their opinions in terms of the scope and content. Necessary adjustments were made in line with their recommendations. Patients in this group were visited in their rooms at least 12 hours before undergoing surgery by a multidisciplinary team consisting of a surgeon, an anesthesiologist, and a nurse. The multidisciplinary team visited the patients at the same time and provided their education after introducing the team. Structured verbal education and written documents were given to the patients for 30 minutes on preoperative preparation, anesthesia, intubation, mobilization, deep breathing and coughing exercises, nutrition and fluid management, the postoperative recovery process, clinical practice guideline and operating room protocols.
15751133|NCT04850573|Other|equine assisted activities|Participants interact with the horse and learn how to safely handle the horse.
15751134|NCT04850560|Biological|CD19 PD-1/CD28 CAR-T Plus Low Dose Decitabine|CD19 PD-1/CD28 CAR-T Plus Low Dose Decitabine
15751135|NCT04850521|Other|Remote monitoring|patient-facing app + connected spirometer + connected pulse oximeter + clinician view portal
15751136|NCT04850508|Device|Mapping and ablation with the Advisor HD Grid catheter|"After confirmation of isolation of the first pair of veins, the CMC-20 catheter will be exchanged for the HD Grid catheter. Using the HD Grid catheter, a new map of the left atrium will be made using the high-density settings. Together with the left atrium, the pulmonary veins will be mapped again in search of electro-anatomical gaps. Gaps are defined as a local area from the ablation line reaching inwards the pulmonary vein which still shows activation or fractionated potentials in line with atrial activation whilst pacing remote in the left atrium. The After mapping the first ablation side, the CMC-20 will be reinserted to repeat the protocol for the remaining pair of veins 30 minutes after ablation ended for that side.
~If gaps have been found, HD Grid guided additional ablation must be performed to achieve isolation in that vein until isolation is reconfirmed."
15751137|NCT04850495|Drug|Cyclophosphamide|Given IV
15751138|NCT04850495|Drug|Doxorubicin Hydrochloride|Given IV
15751139|NCT04850495|Drug|Prednisone|Given PO
15751140|NCT04850495|Biological|Rituximab|Given IV
15751141|NCT04850495|Drug|Vincristine Sulfate|Given IV
15751142|NCT04850495|Drug|Zanubrutinib|Given PO
15751143|NCT04850482|Other|MyJourney|MyJourney is an online self-help interactive program based on Contextual Cognitive Behavioural Therapy.
15751144|NCT04850430|Procedure|Gastric venous reconstruction|Patients will be assigned to study after intraoperative evaluation of gastric venous drainage after coronary vein resection during TP, and the gastric venous outflow will be reconstructed after TP.
15751145|NCT04850417|Drug|Beta blocker, aspirin, clopidogrel|Pragmatic design. Beta-blockers and Antiplatelets drugs selected by the investigators. Asprin and Clopidogrel recomended for patients allocated to prologed DAPT. Aspirin Alone recomended for patients allocated to short antiplatelet therapy
15751146|NCT04850404|Procedure|abdominal nerve block|All Patients of group A-M will be administered with rectus abdominis block combined with TAPB after anesthesia. Rocuronium was infused continuously (concentration: 1 mg/ml) when TOF recovered to 1. The starting rate was 0.3mg/kg/h, and the TOF count was maintained between 1~3 (moderate NMB) and recorded during the operation. Whether and how to add rocuronium was based on TOF count and request of surgeons. When TOF Watch- SX showed 4 or ratio, the investigators increased the speed of rocuronium pump infusion and record the score at the time of shallow NMB. When the chief surgeon thought the vision could not satisfy the needs of the operation, rocuronium 0.1mg/kg in bolus was added as a rescue. Then, the pump speed was lowered or even decreased to 0 to make the TOF count recover to 1~3 as soon as possible.
15751147|NCT04850391|Other|Mobile app|To compare changes induced by the movile app intervention among the three study groups
15751148|NCT04850378|Drug|Dalteparin|Drug: Dalteparin 200 units/kg once a day for 4-7 days.
15751149|NCT04850378|Drug|Apixaban|Drug: Apixaban 5 mg twice a day for 4-7 days.
15751150|NCT04850365|Procedure|Hysteropexy|"Abdominal Sacral cervicopexy:
~The approach involves suspending the cervix to the anterior longitudinal ligament on the sacrum using permanent sutures or polypropylene mesh.
~Vaginal Sacrospinous cervicopexy:
~This transvaginal extraperitoneal technique involves suspending the sacrospinous ligament to the cervix using either a dissolvable or permanent suture. The suspension is performed in a unilateral fashion."
15751151|NCT04850352|Dietary Supplement|Heukcha Extracts|Experimental group: Heukcha Extracts
15751152|NCT04850352|Dietary Supplement|Placebo|Placebo group
15751153|NCT04850339|Biological|ANXV|Intravenous infusion
15751154|NCT04850339|Other|Placebo|Intravenous infusion
15751155|NCT04850326|Dietary Supplement|AP green tea extract|single intake of AP green tea extract
15751156|NCT04850313|Device|ProProKera Plus®|ProKera® is a sutureless form of CryoTek amniotic membrane that is clipped into a dual polycarbonate ring system with the epithelial side up when in contact with the ocular surface.
15751157|NCT04850300|Procedure|Total knee prosthesis with medial condylar stabilization|Surgery will be done of Total knee prosthesis with medial condylar stabilization
15751158|NCT04850300|Procedure|Total knee prosthesis with central pivot stabilization|Surgery will be done of Total knee prosthesis with central pivot stabilization
15751159|NCT04850287|Behavioral|Digital Sensors for Population Awareness about Health Issues using Social Media|A clustered randomized control trial will be conducted and ZIP Codes from each demographic environment will be randomly assigned to control and intervention arms. Digital educational materials about organ donation will be exposed to online users in social media belonging to ZIP Codes assigned to the intervention arm
15751166|NCT04850222|Drug|Fluoxetine|Subjects will be randomized to take Fluoxetine (10mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
15751167|NCT04850222|Drug|Calcium|Subjects will be randomized to take Calcium supplementation (1000mg by mouth per day). The randomized drug will be prescribed by the orthopedic team on the day randomization so that the patient may be monitored for side effects during the remainder of their hospitalization. The patient will be prescribed the randomized medication on the day of discharge and a 90 day supply will be provided by the inpatient research pharmacy.
15751168|NCT04850209|Other|oral and written education|oral and written education
15751169|NCT04850209|Other|Wechat group|Wechat group: oral and written education plus Wechat group based interactive education provided by medical professional
15751170|NCT04850196|Device|TEAS|TEAS treatment was performed for 30 mins before anesthesia on bilateral side by an experienced acupuncturist at the Neiguan (PC6), HT7 (Shenmen), ST36 (Zusanli) and LI4 (Hegu) acupoints . And TEAS treatment for 30 mins was also performed on bilateral side by an experienced acupuncturist at the Neiguan (PC6), HT7 (Shenmen), ST36 (Zusanli) and LI4 (Hegu) acupoints at the end of surgery as well as on the each night before sleeping after surgery until discharged from the hospital
15751171|NCT04850196|Other|control group|Patients in the Control group received electrical stimulation at a non-acupoint which was located 2 cm interior to the bilateral Neiguan (PC6), HT7 (Shenmen), ST36 (Zusanli) and LI4 (Hegu) acupoints similar to patients in group TEAS
15751172|NCT04850183|Behavioral|Education on disease management on the quality of life, and anxiety and depression about Rheumatoid Arthritis|The patients in the intervention group participated in a one-to-one training program consisting of a 30-min onset session.
15751173|NCT04850170|Procedure|manual therapy|"release and stretch the muscles and fascia around shoulder girdle、upper arm and forearm;
~massage the masseter muscle and temporalis muscle;
~mobilization of the temporomandibular joint, the thoracic and cervical spine, shoulder, and elbow."
15751174|NCT04850170|Procedure|Speech therapy|include the stretching of the neck, facial and oral movement training, and swallowing training
15751175|NCT04850157|Drug|Tislelizumab|200mg, Q3W
15751176|NCT04850157|Radiation|IMRT|4 Gy* 5 Fx,5Fx/Week
15751184|NCT04850131|Procedure|Desarda repair|Desarda is a new tissue-based technique developed from applying the externally oblique muscle aponeurosis in the form of an undetached strip making the posterior wall in the inguinal canal stiffer. This paper focuses on analyzing comparisons between mesh-free Desarda repair and the Lichtenstein technique for the treatment of hernia inguinalis
15751185|NCT04850118|Biological|rAAV2tYF-GRK1-hRPGRco|Adeno-associated virus vector expressing a human RPGR gene
15751187|NCT04850092|Other|Positional change from supine to prone|Patient is turned from supine to prone position for spine surgery
15751188|NCT04850066|Behavioral|Equine-assisted intervention|Usual care including an equine-assisted intervention carried out on foot, next to the horse, in 3 sessions of 3 hours each, spread over 4 weeks. This program is based on self-awareness, communication, assertiveness and adaptability.
15751189|NCT04850040|Drug|Apatinib Mesylate|250 mg, oral every other day. Approximately half an hour after a meal (the daily dose should be taken at the same time as possible) with warm boiled water.
15751190|NCT04850040|Drug|Camrelizumab|200 mg, 30 minutes intravenous drip (overall dosing time no shorter than 20 minutes and no longer than 60 minutes, including tube flush time) once every 2 weeks, with the first dose administered concurrently with Apatinib Mesylate Tablets.
15751191|NCT04850040|Drug|Oxaliplatin|85 mg/m2, once every 2 weeks, to be administered half an hour after Camrelizumab injection.
15751192|NCT04850027|Procedure|TME+Lateral lymph node dissection.|TME and lateral lymph node dissection is performed in rectal cancer patients with lateral lymph node short diameter ≥ 5 mm.
15751193|NCT04850014|Other|Anthropomorphism|Height, weight, body surface area, body mass index, exact age (date of birth or age in days, months and years), falling which year of birth gender
15751194|NCT04850014|Other|Relevant clinical datas|"Medical history Concomitant medication Paracetamol intake : dosage, delay, context, route of intake Alcohol intake Smoking status (including active and passive exposition or no exposition) Curative treatment / Antidote / purifying treatment received and time of introduction Clinical signs, Acetaminophen concentration in plasma with associated accurate time of sampling (date, hour and time following acetaminophen intake Liver and kindney function assessment by measure measuring plasma concentration of: AST, ALT, Factor V, Prothrombin, APTT, INR, albuminemia, bilirubin, phosphorus, pH, creatitine. And GFR estimation.
~Imaging."
15751195|NCT04850001|Drug|Aspirin Tablet, Clopidogrel Bisulfate Tablets and Atorvastatin|All patients received standard medical management, including dual antiplatelet therapy (aspirin and clopidogrel) for three months with aspirin or clopidogrel monotherapy thereafter and high-dose statin, and treatment of hypertension to guideline targets.
15751196|NCT04849988|Drug|ABP-450|ABP-450 (prabotulinumtoxinA) contains a 900kDA botulinum toxin type-A complex produced by the bacterium Clostridium botulinum.
15751197|NCT04849988|Drug|Placebo|0.9% sodium chloride, sterile, unpreserved, USP/Ph.Eur.
15751260|NCT04849520|Device|Buccal oxygenation|Oxygen supplement intra-orally via oral Ring-Adair-Elwyn endotracheal tube connected to oxygen at a rate of 0.5 liters/kg/min
15751198|NCT04849975|Other|Pelvimetric measurements|The patients in this group are pregnant women after failure of external manual version (EMV) in case of breech fetal presentation. The participants will successively perform MRI pelvimetry (conventional management) and EOS imaging.
15751199|NCT04849962|Other|Control|Participants in this group received a traditional muffin with butter as the predominant source of fat.
15751200|NCT04849962|Other|Pecan|Participants in this group received a muffin in which part of the butter was substituted out for pecans.
15751201|NCT04849949|Other|Control|Participants in this group received a traditional muffin with butter as the predominant source of fat.
15751202|NCT04849949|Other|Black walnut|Participants in this group received a muffin in which part of the butter was substituted out for black walnuts.
15751203|NCT04849949|Other|English walnut|Participants in this group received a muffin in which part of the butter was substituted out for English walnuts.
15751204|NCT04849936|Diagnostic Test|Testing Fecal Biomarkers In Comparison To Endoscopic Examination With Confocal Laser Endomicroscopy|Patients, who were examined during a routine diagnostics, should submit an extra morning stool sample up to two weeks before or after the gastroscopy and/or coloscopy to generate the data of the fecal biomarker mentioned above.
15751205|NCT04849923|Other|Strength training session|Conduct of an 8-week strength training intervention of key muscle-tendon groups associated with knee joint stability in the training-specific setting of each participant. Participants are randomly allocated into three study groups with increasing levels of loading (Group#1: no training, Group#2: 1 training per week, Group#3: 3 trainings per week) with the same number of subjects and gender distribution in each group (n=12 per group, 6F and 6M). The same guidelines for the warm-up and the type of exercises will be given prior to the intervention study to each participant. Participants are asked to record exercise load and volume as well as monitor training-related variables and 1RM using the iOS Strength Control app. Participants perform the strength training self-directedly in their chosen fitness/training facilities as it fits into their weekly routine. Contact to the study investigator is ensured at all times in case of questions.
15751206|NCT04849910|Biological|VOR33|Allogeneic, human leukocyte antigen (HLA) matched, genome edited hematopoietic stem and progenitor cell (HSPC) therapy product lacking the CD33 myeloid protein
15751207|NCT04849910|Drug|Mylotarg|Infusion of Mylotarg
15751208|NCT04849897|Device|Experimental: Virtual Reality Guided Imagery|Platform and VR Goggles
15751209|NCT04849897|Other|Active Comparator: Audio Only Guided Imagery|Audio Recordings of Guided Imagery via an iPAD
15751210|NCT04849884|Device|REAL INTELLIGENCE Tensioner|Robotic TKA procedure with the CORI Surgical System including the use of the REAL INTELLIGENCE Tensioner accessory.
15751211|NCT04849871|Radiation|External Beam Accelerated Partial Breast Irradiation|APBI simulation must take place no more than 8 weeks from final definitive breast surgery.
15751212|NCT04849858|Drug|Bupivacaine|Participants in this group will receive a TAP block using the drug Bupivacaine.
15751213|NCT04849858|Drug|Liposomal bupivacaine|Participants in this group will receive a TAP block using the drug Liposomal Bupivacaine.
15751214|NCT04849858|Drug|Liposomal bupivacaine|Participants in this group will receive a TAP block using the drug Liposomal Bupivacaine followed by a re-dosing during their hospitalization
15751215|NCT04849845|Combination Product|Afrezza Dose 1|The first dose of Afrezza will be based on the dose of subcutaneous rapid-acting analogue (RAA) insulin that the subject would normally take for the standardized meal, converted according to the guidelines provided in the current Afrezza U.S. prescribing information.
15751216|NCT04849845|Combination Product|Afrezza Dose 2|The second dose of Afrezza will be based on the dose of subcutaneous rapid-acting analogue that the subject would normally take for the standardized meal, converted by multiplying their RAA dose by 2 and rounding down to the nearest Afrezza cartridge size.
15751217|NCT04849832|Dietary Supplement|SIC|Sodium Iron Chlorophyllin as prepared by the human nutrition laboratory, ETH Zurich
15751218|NCT04849832|Dietary Supplement|SIC + tea|Sodium Iron Chlorophyllin as prepared by the human nutrition laboratory, ETH Zurich with 2g of tea brewed for 5 minutes
15751219|NCT04849832|Dietary Supplement|FeSO4|Ferrous sulfate solution serves as a positive control - and whose absorption is well known.
15751220|NCT04849832|Dietary Supplement|FeSO4 + tea|Ferrous sulfate solution given with 2g of tea brewed for 5 minutes - expected iron absorption inhibition
15751221|NCT04849819|Drug|Corticosteroids, immunosuppressors, biological agents|We do not prescribe new medications to patients but only observe their adverse effects on the eye.
15751222|NCT04849806|Diagnostic Test|Assessments of the sympathetic nerve activity axis|"For assessment sympathovagal balance (SVB), HRV and dBPV will be analysed using a 3-lead electrocardiogram (sampling rate 1000Hz) and a continuous non-invasive arterial blood pressure signal (CNAP® technology, sampling rate 100Hz). HRV (ms2 based on continuously recorded variability in RR intervals) and (diastolic) BPV (expressed as mmHg2 based on continuously recorded variability in diastolic BP) will be computed by time domain analysis and by frequency domain analysis and presented as the high frequency component (HF; 0.15-0.4 Hz), low frequency component (LF; 0.04-0.15 Hz), their relative ratio (LF/HF), and the very low frequency component (VLF; 0.0-0.04 Hz) for both HRV and dBPV .
~Muscle SNA will be recorded via a tungsten microelectrode carefully placed in the peroneal nerve. Plasma catecholamines will also be assessed."
15751223|NCT04849806|Diagnostic Test|OSA severity|OSA is defined as apnoea-hypopnoea index [AHI] >15/h and obstructive apnoea index [OAI] >5/h) and sleep architecture
15751224|NCT04849806|Diagnostic Test|Determination of PH and right HF severity|(defined as tricuspid annular plane systolic excursion ≤14 mm) and pulmonary arterial pressure (PAsys) using transthoracic echocardiography
15751225|NCT04849806|Diagnostic Test|Comprehensive lung function and inspiratory muscle function testing.|Respiratory Muscle strength and function testing as previously established by our group and Assessment of daytime hypoxia (PaO2 <55 mmHg) and hypercapnia (PaCO2 >45 mmHg) using capillary blood gas analysis.
15751226|NCT04849806|Diagnostic Test|Assessment of systemic inflammation|Based on blood samples taken.
15751261|NCT04849507|Device|transcutaneous auricular vagus nerve stimulation|Stimulation of the auricular branch of the left vagus nerve paired with oromotor feeding.
15751434|NCT04848051|Behavioral|CRC screening reminder|Participants randomized to the CRC Reminder arm will receive reminder that they are due/overdue for CRC screening
15751924|NCT04843995|Procedure|Mid-urethral sling|Treatment of stress urinary incontinence with retropubic mid-urethral sling
15751227|NCT04849793|Other|Acupressure|Before starting the application, the students will be asked to rub the area around the area to be pressed for 20-30 seconds with their palms. With the gentle rubbing of the surrounding tissue, the tension and tissue sensitivity in the area of warming, relaxing and preparatory will be reduced and the tissue will be relieved. . The students will be asked to press the designated point manually with their thumb, index or middle finger for 5 seconds with a depth of 1-1.5 cm, rest for 2 seconds and continue the practice for 2 minutes
15751228|NCT04849780|Device|ACUVUE Oasys 1-Day|TEST
15751229|NCT04849780|Device|Habitual Lens|Subjects' own Habitual Lenses
15751230|NCT04849767|Other|Questionnaire|Questionnaire about socio-behavioral items and conditions of vulnerability. interview with female to male transgender person will be about life conditions, trajectory of the medical transition from female to male and actual medical following of the transition, migration trajectory and condition of HIV acquisition.
15751231|NCT04849754|Diagnostic Test|bone scintigraphy|Bone scintigraphy
15751235|NCT04849715|Drug|parsaclisib|parsaclisib will be administered orally once daily.
15751236|NCT04849715|Drug|rituximab|rituximab is administered IV on Day 1 of each 28-day cycle for 6 cycles.
15751237|NCT04849715|Drug|bendamustine|bendamustine is administered IV on Day 1 and 2 of each 28-day cycle for 6 cycles.
15751238|NCT04849715|Drug|Placebo|placebo will be administered orally once daily
15751239|NCT04849702|Procedure|No intervention was compared|No intervention was compared
15751240|NCT04849689|Behavioral|Whole-food, plant-based lifestyle|"The WFPB lifestyle program included:
~Nutrition/plant-based food (energy intake: at least 90% of whole-food, plant-based diet and ≤ 10% of energy intake from plant-based meal replacements (PBMR) and dietary supplements (e.g., vitamin B12, D, and EPA and DHA omega-3 fatty acids).
~Physical activity (habitual; organized and other).
~Support system (lectures, workshops and individual nutrition counselling, grocery shopping assistance, cooking classes, regular measurements body composition, food logging, regular medical monitoring)."
15751241|NCT04849676|Other|visual neurofeedback|"Neurofeedback is a neuromodulatory intervention that does not require applying external stimuli. It relies on displaying participants' brain activity in real time, with the aim of modifying it. Electrical activity (EEG) will be recorded from participants and displayed in real time on a computer screen, in the form of three bars. They will be asked to increase the middle bar, while keeping the side bars low.
~The intervention requires training to achieve voluntary control of the targeted brain activity."
15751242|NCT04849663|Biological|free fat graft|fat harvested from patient will be used to cover exposed root
15751243|NCT04849663|Biological|subepithelial graft|subepitheial graft harvested from palate
15751244|NCT04849650|Drug|Amisulpride IV|A single 10mg IV dose of Amisulpride given over 1 minute
15751245|NCT04849650|Drug|Amisulpride Oral Tablet|A single 10mg dose given as an oral tablet
15751246|NCT04849637|Drug|Virgin Coconut Oil|Oral supplementation of virgin coconut oil to COVID-19 patients
15751247|NCT04849624|Other|No Intervention|This is an observational study and involved no intervention
15751248|NCT04849598|Other|Oxygen therapy|Oxygen therapy during ESWTs and Stair Walking Test: one test using the prescribed constant oxygen flow and one using an automatic oxygen titration system. SpO2 target range: 90 - 94%
15751249|NCT04849585|Other|semi-directed entretien|semi-directed entretien
15751250|NCT04849572|Behavioral|Sleep Education|"Week 1-2: All 100 participants will have sleep parameters recorded as baseline for the first two weeks.
~Week 3: 50 participants (Arm 1) will watch a 10 to 20 minute sleep hygiene video followed by a post-test questionnaire to confirm participation and understanding.
~Week 5: Arm 1 will again view the educational video at week 5
~Week 6-8: Baseline sleep data on all participants will be downloaded for review and the PSQI questionnaire administered for both groups. Participants will be also be asked if they underwent any major health crisis during the study period which may have impacted their sleep (hospitalization, significant medication changes which they believe impacted sleep, any use of illicit drugs during the study periods or significant increase in alcohol consumption (e.g., doubling).
~Week 9: Arm 1 will continue re-education
~Week 11: Arm 1 continues education
~Week 12-14: Data from Oura ring will be downloaded and PSQI administered to both groups."
15751251|NCT04849572|Behavioral|Delayed Sleep Education|"Week 1-2: All 100 participants will have sleep parameters recorded as baseline for the first two weeks.
~Week 3: 50 participants (Arm 2) will be controls with no education.
~Week 6-8: Baseline sleep data on all participants will be downloaded for review and the PSQI questionnaire administered for both groups. Participants will be also be asked if they underwent any major health crisis during the study period which may have impacted their sleep (hospitalization, significant medication changes which they believe impacted sleep, any use of illicit drugs during the study periods or significant increase in alcohol consumption (e.g., doubling).
~Week 9: Arm 2 will join in for video education along with post-test
~Week 11: Arm 2 will undergo reeducation with post-test for 20 mins
~Week 12-14: Data from Oura ring will be downloaded and PSQI administered to both groups."
15751252|NCT04849559|Drug|Tradipitant|Tradipitant Capsule
15751253|NCT04849559|Drug|Placebo|Placebo Capsule
15751254|NCT04849533|Drug|Belatacept|belatacept with everolimus is experimental regimen and it is compared to the labeled regimen of belatacept with mycophenolate with steroids for prevention of rejection in renal transplant recipients
15751255|NCT04849533|Drug|Everolimus|belatacept with everolimus is experimental regimen and it is compared to the labeled regimen of belatacept with mycophenolate with steroids for prevention of rejection in renal transplant recipients
15751256|NCT04849533|Drug|mycophenolate mofetil|belatacept with mycophenolate is approved regimen for prevention of rejection
15751257|NCT04849533|Drug|corticosteroids|belatacept with chronic steroids is approved regimen for prevention of rejection
15751258|NCT04849533|Drug|rabbit antithymocyte globulin|rabbit antithymocyte globulin induction for prevention of rejection
15751259|NCT04849520|Device|High flow nasal cannula|Oxygen supplement via high flow nasal cannula at a rate of 2 liters/kg/min
15751262|NCT04849494|Other|ATS-DLD-78-C and ISAAC questionnaires|Early, natal and postnatal period data were recorded from the hospital database system and patient file. The morbidities observed during the follow-up of the newborns, the duration of hospitalization, needed of oxygen, surfactant administration, positive pressure ventilation requirement, and need for mechanical ventilation support and duration were noted from patient file records. Anthropometric measurements of all patients were taken. Demographic information, socioeconomic level, mother/father education level, mother's smoking status and medical history were questioned, and physical examinations of the patients were performed. were performed for screening respiratory diseases. After the physical examination, the validated Turkish forms of ATS-DLD-78-C and ISAAC questionnaires were filled in face-to-face by the research doctor who did not know the patients' medical history
15751263|NCT04849468|Drug|Declofenac|evaluating the preemptive effect of intramuscular declofenac on postoperative analgesia in patients undergoing perianal surgeries under saddle block
15751264|NCT04849468|Drug|saline|evaluating the preemptive effect of intramuscular saline on postoperative analgesia in patients undergoing perianal surgeries under saddle block as control
15751265|NCT04849455|Drug|0.2% ropivacaine local anesthetic continuous erector spinae plane block|Treatment- continuous erector spinae block catheter followed by an infusion of ropivacaine 0.2% at 10ml automatic set bolus per 60 minute with 2ml/hr continuous infusion (12mls/hr total per catheter)
15751266|NCT04849455|Drug|0.2% ropivacaine local anesthetic superficially taped continuous erector spinae plane block|Placebo- Superficially placed (taped to the surface) erector spinae block catheter with a ropivacaine 0.2% infusion at 0.1ml /hr
15751267|NCT04849455|Drug|Spinal Morphine|200-300 mcg of spinal morphine
15751268|NCT04849429|Biological|Platelet rich plasma (PRP) with exosomes|Autologous Platelet rich plasma (PRP) with exosomes Following skin disinfection of the back 2 ml from the total PRPex procured will be injected as soon as possible by an fluoroscopy guided lateral approach.
15751269|NCT04849416|Drug|LOXO-305|Administered orally.
15751270|NCT04849403|Procedure|CTSP|In all patients Carter Thomasson Suture Passer (CTSP) were used for closing fascial defect peroperatively
15751271|NCT04849390|Drug|ESO-101|Daily administration in the evening at bedtime for 28 days
15751272|NCT04849390|Drug|Placebo|Daily administration in the evening at bedtime for 28 days
15751273|NCT04849377|Radiation|RT 50 Gy|Radiation Therapy (RT) 50 GY
15751274|NCT04849377|Radiation|RT 54 GY|Radiation Therapy (RT) 54 GY
15751275|NCT04849377|Radiation|RT 60 GY|Radiation Therapy (RT) 60 GY
15751276|NCT04849377|Other|Induction Therapy|Induction Therapy: Cisplatin, Docetaxel, Fluorouracil
15751277|NCT04849377|Drug|Carboplatin|Carboplatin AUC 9.0
15751278|NCT04849377|Drug|Cisplatin 200|200 mg/m2
15751279|NCT04849377|Drug|Cisplatin 240|240mg/m2
15751280|NCT04849364|Drug|Capecitabine|Capecitabine 1000 mg/m2 BID Orally 14 days on and 7 days off Cycle = 21 days; Total of 8 cycles
15751281|NCT04849364|Drug|Talazoparib|Talazoparib Cycle 1: 0.75 mg then Cycle 2-8: 1 mg Cycle = 21 days; Total of 8 cycles
15751282|NCT04849364|Drug|Atezolizumab|Atezolizumab 1200 mg IV over 1 hour Cycle = 21 days; Total of 8 cycles
15751283|NCT04849364|Drug|Inavolisib|Inavolisib Cycle 1: 6 mg then Cycle 2-8: 9mg Orally 21 days on Cycle = 21 days; Total of 8 cycles
15751284|NCT04849364|Other|Treatment of Choice|Treatment of patient and physician's choice will be given with strong consideration for capecitabine given the data from CREATE-X. Dose, schedule and duration of treatment to be determined by treating physician.
15751285|NCT04849351|Drug|HMPL-689|All patients are to receive monotherapy of HMPL-689 30 mg QD continuously in 28-day treatment cycles.
15751286|NCT04849338|Diagnostic Test|Bleeding score ( questionnaire )|Bleeding score is done for children diagnosed as von Willebrand's disease .
15751287|NCT04849325|Device|Sirolimus-eluting Iron Bioresorbable Peripheral Scaffold System (IBS Titan™)|Subjects in this arm will be treated with IBS Titan™.
15751288|NCT04849325|Device|Percutaneous Transluminal Angioplasty (PTA) Device|Subjects in this arm will be treated with PTA device.
15751289|NCT04849299|Drug|AT-527 550 mg + cyclosporine|550 mg AT-527 alone on Day 1 and 550 mg AT-527 plus 600 mg cyclosporine administered simultaneously on Day 7 Other Names: AT-527 is also known as R07496998
15751290|NCT04849299|Drug|AT-527 550 mg + cyclosporine|550 mg AT-527 alone on Day 1 and 550 mg AT-527 plus 600 mg cyclosporine administered on Day 7 (with dosing offset by 2 hrs) Other Names: AT-527 is also known as R07496998
15751291|NCT04849286|Drug|HTL0016878|Oral solution
15751292|NCT04849273|Drug|TPX-0131|Oral TPX-0131 tablets
15751293|NCT04849260|Biological|Pexa-Vec combined with ZKAB001|"Intratumoral injection of low dose Pexa-Vec (3×10^8pfu) combined with intravenous of ZKAB001 (5mg/kg), every 2 weeks as one cycle.
~Intratumoral injection of high dose Pexa-Vec (1×10^9pfu) combined with intravenous of ZKAB001 (5mg/kg), every 2 weeks as one cycle."
15751294|NCT04849260|Biological|ZKAB001 monotherapy|ZKAB001 monotherapy
15751295|NCT04849247|Drug|68Ga-DOTA-FAPI, 177Lu-DOTA-FAPI|PET imaging using 68Ga-DOTA-FAPI will be used to diagnose patients who are eligible for treatment with the 177Lu-DOTA-FAPI.
15751296|NCT04849234|Behavioral|newborn cries|"Their cries will be longitudinally registered from the age of birth until the first 15 minutes of birth using an automatic record device: Recorder ZOOM H4N.
~The wav-sized files obtained from each recording will then be analyzed indiscriminately via an acoustic processing script created for the PRAAT software® by the post-doctoral fellows of the ENES laboratory (Sensory NeuroEthology Team) on the site of the Faculty of Sciences of Saint-Etienne."
15751297|NCT04849221|Other|Tympanometry measurement in both ears|Measurement once or twice a day and at every change of more than 10 mmHg in ICP, over the entire period of time that ICP is measured by a probe or DVE
15751298|NCT04849221|Other|Collection of clinical and paraclinical data|"Patient: gender, weight/height, age, etiology of ICP entry, reason for ICP monitoring, presence of external (otoscopy), middle (otoscopy + CT) or internal (CT) ear abnormality, presence of inclusion and non-inclusion criteria, measurement of patient tilt.
~healthy subjects: gender, weight/height, age, presence of abnormality of the external (otoscopy), middle (otoscopy) or internal ear (questioning), presence of inclusion and non-inclusion criteria..."
15751299|NCT04849221|Other|Intracranial pressure reading (ICP)|a single measure
15751366|NCT04848584|Biological|Primary Exposure Status of Pfizer-BioNTech COVID-19 Vaccine|Pfizer-BioNTech COVID-19 vaccine
15792547|NCT04512404|Drug|HMG-CoA Reductase Inhibitor|
15751300|NCT04849208|Other|Presentation of fast and slow trials|"In each task trial participants will solve a reasoning problem. Half of the trials will be traditional Slow trials in which participants get ample time to deliberate (i.e., 20 s). The other half of the trials will be Fast trials in which people do not get sufficient time to deliberate (i.e., 4 s deadline) and need to rely on intuitive processing"
15751301|NCT04849195|Other|No intervention|No intervention
15751302|NCT04849182|Dietary Supplement|Vertistop D|Food supplement containing alpha-lipoic acid, carnosine, zinc, vitamin D3 and vitamins of group B, 1 tablet/day before meals
15751303|NCT04849182|Dietary Supplement|Vertistop L|Food supplement containing alpha-lipoic acid, carnosine, zinc and curcumin, 2 tablets/day (morning and evening)
15751304|NCT04849169|Device|Experimental|Prolonged balloon inflation for hemorrhage management due to coronary artery perforation.
15751305|NCT04849156|Other|Sperm selection by thermotaxis|Selection of healthy sperm by thermotaxis procedure
15751306|NCT04849143|Other|Stingless bee honey ( Kelulut honey)|"The honey will be acquired from Brainey Sdn Bhd, a company that provides stingless bee honey certified with Good Manufacturing Practice (GMP), ISO 22000, and Halal.
~As the honey used is not medical-grade honey, sterilization with 25kGy gamma-ray irradiation will be done for safety purposes to eradicate any potential life-threatening infection such as spores from Clostridium botulinum."
15751307|NCT04849143|Other|Gel dressing|Smith-Nephew's Intrasite gel
15751308|NCT04849130|Procedure|Static reconstruction technique according to Schöttle|In static MPFL reconstruction, a graft (harvested autologous gracilis tendon or allogen transplant) is attached to the femoral and patellar bones using tunnels, screws, and/or anchors.
15751309|NCT04849130|Procedure|Dynamic reconstruction technique according to Becher|Dynamic MPFL procedure by detaching and reinserting only the distal part of a hamstring muscle to the patella and leaving the proximal tendon attached to its muscle. This way the patella position can be adjusted dynamically by hamstring contraction.
15751310|NCT04849117|Procedure|Ultrasound guided Bilateral Transversus Thoracis Muscle Plane block|"In the TTMP block group, an ultrasounded guided TTMP block was performed by an anesthesiologist, in ICU, before tracheal tube removal. Between the 4th et 5th rib, on each side, 40 ml of Ropivacaine 2 mg/ml, in association with Clonidine, was injected single-shot in the tranversus thoracis muscle plane. The targets of local anesthetic were the anterior branches of intercostal nerves from T2 to T6. Dexamethasone 8 mg was injected intravenously."
15751311|NCT04849091|Device|iReadMore|Digital Alexia Therapy
15751312|NCT04849065|Drug|MNC (Mononuclear cells)|"Intramuscular infusion of autologous BM CMN into the TA muscle of one of the lower limbs (experimental side)
~Intramuscular infusion of saline solution (placebo) in the TA muscle of the contralateral lower limb (control side)"
15751313|NCT04849065|Drug|Placebo / Saline|- Intramuscular infusion of saline solution (placebo) in the TA muscle of the contralateral lower limb (control side)
15751314|NCT04849052|Behavioral|MASTERY|In MASTERY, participants will have interactive, two-way text message 'sessions' (5-10 minutes of two-way text communication with an automated text-message program) once weekly for 12 weeks. Furthermore, study trainers will conduct 3 brief calls with participants (Weeks 1, 4, and 7) to introduce the program, assess progress, answer questions, and provide support.
15751315|NCT04849052|Behavioral|Attentional Control|Participants in the control condition will also receive text messages once per week. To ensure time matching, the program will have 3 phone check-ins (on physical activity) as in MASTERY.
15751316|NCT04849026|Drug|Clozaril 100 mg (Clozapine)|2 Doses/Day for 10 days
15751317|NCT04849026|Drug|WID-CLZ18|2 Doses/Day for 10 days
15751318|NCT04849013|Drug|Placebo|Drug: Placebo Capsules containing mannitol looking identical to the other drugs Other: Placebo Capsules containing mannitol looking identical to the other drugs
15751319|NCT04849013|Drug|Mescaline 100mg|"Drug: 100mg Mescaline per os, single dose
~Other: Placebo (Capsules containing mannitol looking identical to the other drugs)"
15751320|NCT04849013|Drug|Mescaline 200mg|"Drug: 200mg Mescaline per os, single dose
~Other: Placebo (Capsules containing mannitol looking identical to the other drugs)"
15751321|NCT04849013|Drug|Mescaline 400mg|"Drug: 400mg Mescaline per os, single dose
~Other: Placebo (Capsules containing mannitol looking identical to the other drugs)"
15751322|NCT04849013|Drug|Mescaline 800mg|"Drug: 800mg Mescaline per os, single dose
~Other: Placebo (Capsules containing mannitol looking identical to the other drugs)"
15751323|NCT04849013|Drug|Mescaline 800mg + Ketanserin 40mg|"Drug: 800mg Mescaline per os, single dose
~Other: 40mg Ketanserin per os, single dose"
15751324|NCT04849000|Drug|SHR-1209|SHR-1209
15751325|NCT04849000|Drug|SHR-1209 Placebo|SHR-1209 Placebo
15751326|NCT04848987|Procedure|Etching|Etching enamel surface using phosphoric acid
15751327|NCT04848974|Drug|Cladribine|Given IV
15751328|NCT04848974|Drug|Cytarabine|Given SC
15751329|NCT04848974|Drug|Uproleselan|Given IV
15751330|NCT04848961|Behavioral|LungTalk|MSK developed LungTalk, a novel computer-tailored health communication and decision support tool to (1) increase awareness and knowledge about lung screening; (2) decrease perceived barriers to screening based upon misinformation; and (3) increase screening rates.
15751331|NCT04848948|Behavioral|Calory Restriction (F.X. Mayr & VLCD)|"VLCD restricts calory intake to 630 - 700 kcal per day (20% fat, 34% protein, 46% carbohydrates).
~F.X. Mayr diet similarly applies calorie restriction to 700 - 800 kcal per day and includes daily ingestion of isotonic magnesium sulfate solution."
15751332|NCT04848948|Behavioral|Biofeedback|Three sessions of biofeedback (50 minutes) over a time frame of 14 days, aimed at improving biological functions and especially heart-rate-variability under stress condition.
15751333|NCT04848935|Device|CURATE.AI|CURATE.AI will be utilised to provide personalised training intensity recommendations (low, medium or high) to the patients during the digital cognitive test battery DI session. The difficulty of each task will be modulated by CURATE.AI by adjusting the frequency of critical events that demand evaluation and/or response.
15751334|NCT04848922|Other|Hot shower intervention|Intervention group took a shower in a standing position at a water temperature of 37-41°C for 10-20 minutes between 6 and 12 hours after vaginally birth.
15751367|NCT04848571|Combination Product|Fetal Protection Pill|A Chinese medicine used in pregnant women for fetal protection, including mainly radix polygoni multiflori, Rehmannia glutinosa.
15751335|NCT04848909|Radiation|stereotactic body radiotherapy (SBRT)|Stereotactic body or external-beam radiation therapy (SBRT) is a method of delivery of radiation in precision manner to the prostate bed in this study. The SBRT dose prescription will be 3000 cGy in 5 fractions to the prostate bed and 2500 cGy in 5 fractions to the pelvic nodes if elective nodal irradiation (ENI) is used, delivered every other business day.
15751336|NCT04848896|Device|CORI Robotics|Total knee arthroplasty (TKA) treated with CORI Robotics System.
15751337|NCT04848896|Procedure|Conventional Procedure|Total knee arthroplasty (TKA) treated with conventional approach with conventional manual instrumentation.
15751339|NCT04848870|Other|Salivary samples|collection of salivary samples from Sjögren patients on routine care in the oral medicine department.NA
15751340|NCT04848857|Drug|Colchicine|colchicine is a potent anti-inflammatory drug which is currently recommended for the treatment of pericarditis and acute gout attacks, but also familial Mediterranean fever and Behçet disease. This drug acts on inflammation through inhibition of microtubule polymerization by binding free tubule dimers. Colchicine blunts monocyte and neutrophil invasion at the site of inflammation and reduces intracellular trafficking and thus the release of cytokine and production of reactive oxygen species and a variety of proteolytic enzymes.
15751341|NCT04848857|Drug|Placebo|the placebo is a drug with no chemical effects but with the same physical characteristics as the experiment drug colchine.
15751342|NCT04848818|Procedure|Distal radial metaphyseal fracture fixation with percutaneous K-wires|Pediatric distal metaphyseal fractures which are severly displaced will be operated with percutaneous K-wires..
15751343|NCT04848818|Procedure|Distal radial and/or ulnar metaphyseal fracture fixation with bidegradable PLGA-based (Activa Im-Nail) implants|Pediatric distal metaphyseal radial and /or ulnar fractures which are severly displaced will be operated with percutaneous bidegradable PLGA-based (Activa Im-Nail) implants.
15751344|NCT04848805|Procedure|liver transplantation|total hepatectomy material was examined by pathology laboratory
15751345|NCT04848792|Dietary Supplement|Sulforaphane|Myrosinase-active whole broccoli sprout material
15751346|NCT04848792|Dietary Supplement|Placebo capsules|Placebo capsules
15751347|NCT04848779|Drug|Alglucosidase alfa GZ419829 (Myozyme)|Pharmaceutical form: Lyophilized powder for solution Route of administration: intravenous
15751348|NCT04848766|Drug|De-escalation Treatment Strategy of dual antiplatelet therapy|Patients receive de-escalation treatment of dual antiplatelet therapy after percutaneous coronary intervention
15751349|NCT04848753|Combination Product|Toripalimab combined with cisplatin and paclitaxel|Specified doses on specified days.
15751350|NCT04848753|Combination Product|Placebo combined with cisplatin and paclitaxel|Specified doses on specified days.
15751351|NCT04848740|Device|ReLex-smile|Using VisuMax femtosecond laser we created the stromal pocket with diameter of 7.6 to 8.0 mm (1 mm larger than the optical zone of the donor lenticule) and cap thickness set to 130 μm from corneal surface and 4 mm superior incision. Hinge position flap was set at 90° angle 50° and width 4 mm, side cut angle 90°. The pocket was dissected using a blunt spatula washed with normal saline. The lenticule was held with lenticule forceps and gently inserted into the pocket through the 4 mm superior incision. Incision position changed according to the position of the highest K values We noticed during intervention that implantation of fresh lenticule depends from corneal thickness, for example if c.th.is 300-400 μm we implanted 1/2 stroma, if c.th.is 400 μm or more we implanted 1/3 stroma Example: if corneal thickness is 300 μm we implanted 150 μm (becoming 450 μm) we added more stroma due to more live keratocytes and stromal steam cells, aiming to overcome dead and non-functional keratocytes
15751352|NCT04848727|Other|Detecting asymmetric lung disease like atelectasis or pneumothorax with electrical impedance tomography (EIT)|"The EIT system will be placed at the subject's bedside to collect EIT measurements: Ventilation distribution%, changes in regional aeration in arbitrary units (AU), dependent and non-dependent silent spaces. A data acquisition cart will also be placed at the subject's bedside to collect hemodynamic and respiratory parameters measurements including: Heart rate (HR), blood pressure (BP), respiratory rate (RR), fraction of inspired oxygen (FiO2), transcutaneous carbon dioxide (TcCO2), and peripheral oxygen saturation (SpO2) via bedside monitoring devices.
~The LuMon belts for neonates are disposable single-patient use belts that are adhesive-free. EIT measurements and data will be collected on each timeperiods (t1 and t2) for approximately 15-30 minutes on invasive or non-invasive ventilatory support."
15751353|NCT04848714|Drug|ANAWIDOW [antivenin latrodectus (black widow) equine immune F(ab)2] lyophilized powder for solution 10 mL|Antivenin latrodectus (black widow) equine immune F(ab)2] lyophilized powder for solution 10 mL for intravenous use [parenteral formulation]; hence, a single-dose fasting pharmacokinetic study is planned.
15751354|NCT04848701|Other|latent phase duration|latent phase duration in post term pregnancies
15751355|NCT04848701|Other|uterocervical angle (UCA)|uterocervical angle is the angle between lower segment of uterus and cervix
15751356|NCT04848688|Drug|Moxidectin 2 mg|Monotherapy, oral administration, single-dose, fixed-dose, 4 tablets a 2 mg to yield an 8 mg final dose.
15751357|NCT04848688|Drug|Ivermectin 3 mg|Monotherapy, oral administration, single-dose, weight dependent, The number of tablets will be adjusted according to the patients' weight to yield 200 ug/kg final dose.
15751358|NCT04848688|Drug|Placebo|Monotherapy, oral administration, single dose, matching number of tablets to either moxidectin or ivermectin
15751359|NCT04848675|Other|Inspiratory muscle strength training|Participants will perform inspiratory muscle strength training.
15751360|NCT04848675|Other|Brisk walking|Participants will perform brisk walking.
15751361|NCT04848662|Drug|BDA MDI (PT027) 160/180 μg|Combination Product: Budesonide/albuterol sulfate metered-dose inhaler 80/90 μg per puff. Two puffs to administer 160/180 μg dose.
15751362|NCT04848662|Drug|Pulmicort Respules 0.5 MG/ML Inhalation Suspension|Budesonide 0.5 mg/ml. Each 2 ml Respule contains 1 mg budesonide.
15751363|NCT04848649|Other|Study arm|Questionnaires, blood sample, skin (for psoriasis patients) or digestive (for IBD patients) biopsy and swab testing
15751364|NCT04848636|Diagnostic Test|Cardiac Sodium and Proton MRI|Sodium-23 MRI of the Heart Proton MRI of the Heart
15751365|NCT04848597|Drug|Recombinant humanized anti-PD-1 monoclonal antibody injection|200mg , once every 3 weeks
15751371|NCT04848532|Behavioral|Weight loss treatment|The intervention will consist of group-based, weekly or biweekly weight loss coaching (75 minutes per session), which will occur via Zoom videoconferencing software. This intervention is designed to facilitate a 5-10% weight loss and engagement in up to 250 min/week of moderate-to-vigorous physical activity, which is the standard recommendation in lifestyle modification programs for adolescents. Participants will also be asked to download and utilize the smartphone app, Fitbit, to track eating behavior. Weight loss coaches will be experts in lifestyle modification who have graduate degrees in psychology or a related field. Participants will be given guidance on how to reduce your calorie intake (using a balanced deficit diet) and gradually increase your physical activity. Participants will learn to set goals for diet, weight, and physical activity.
15751372|NCT04848519|Drug|Pembrolizumab|Given IV
15751373|NCT04848519|Drug|Propranolol Hydrochloride|Given PO
15751374|NCT04848506|Drug|CK-3773274 (5 - 15 mg)|CK-3773274 tablets administered orally
15751375|NCT04848493|Biological|COVID-19 vaccines|This is an observational prospective study whose general objective is to assess the impact of COVID-19 vaccination in terms of induction of humoral and cell-mediated immune responses in selected fragile (altered immunocompetence) populations.
15751376|NCT04848480|Drug|insulin icodec|insulin icodec 700 units/mL, subcutaneously (under the skin), solution for injection once weekly
15751377|NCT04848480|Drug|insulin degludec|insulin degludec 100 units/mL, subcutaneously (under the skin), solution for injection once daily
15751378|NCT04848480|Drug|insulin aspart|insulin aspart 100 units/mL, subcutaneously (under the skin), solution for injection daily
15751379|NCT04848467|Biological|SARS-CoV-2 mRNA Vaccine (CVnCoV)|Two intramuscular injections administered 28 days apart at a dose level of 12 μg mRNA.
15751380|NCT04848467|Biological|Quadrivalent influenza vaccine (QIV)|One intramuscular injection as 0.5 mL. Each 0.5 mL dose will contain 15 μg haemagglutinin (HA) from each of the four influenza strains.
15751381|NCT04848467|Other|Placebo|One intramuscular injection as normal saline [0.9% NaCl].
15751383|NCT04848441|Other|The COVID-19 vaccines BNT162b2, mRNA-1273 and ChAdOx1|The purpose of the study is to compare the effects of BNT162b2, mRNA-1273 and ChAdOx1 with respect to incident COVID-19 infection of different severities.
15751384|NCT04848428|Behavioral|Online mindfulness-based cognitive therapy|The first session will first focus on providing feedback regarding post-surgical pain. The second session will focus on teaching mindfulness strategies. The third session will focus on practicing one of the two strategies. Of note, sessions 2 and 3 will start with cognitive restructuring strategies for the moderate-high risk profile patients. The 4th session consists in a booster providing feedback and reminders about cognitive reactions to pain and mindfulness meditation. The participants will be asked to practice meditation 5 days a week, for a total of 4 weeks
15751385|NCT04848428|Behavioral|Online standardized education|One 15-minute educational session on postoperative pain, the relationship between pain, thoughts and emotions and brief overview of strategies.
15751386|NCT04848415|Other|Point-of-Care Ultrasound|Patients admitted to the ED with abdominal pain and suspicion of bowel obstruction : realization of a Point-of-Care Ultrasound after clinical exam by the Emergency Physician in charge as a standard of care. Beside usual findings, the investigators will search for signs of bowel obstruction: dilated and incompressible small bowel loop, back-and-forth peristalsis sign. Determination of probability of small bowel obstruction. Realization of a computed tomography in search of small bowel obstruction.
15751387|NCT04848402|Device|On-Body Delivery System (OBDS)/Multiple Bolus Injector|Used to administer placebo SC.
15751388|NCT04848402|Device|Single Auto Injector|Used to administer placebo SC.
15751389|NCT04848402|Drug|Placebo|Administered SC.
15751390|NCT04848389|Procedure|Skin Adhesive procedure|The scar is closed in 2 planes. The subcutaneous plane is closed with an absorbable 3/0 vicryl-type thread, the cutaneous plane is closed by applying skin adhesive. A drying time of 25 seconds is necessary to obtain a satisfactory seal.
15751391|NCT04848389|Procedure|Standard suture procedure|The scar is closed in 2 planes. The subcutaneous plane is closed with an absorbable thread of the 3/0 Vicryl-type, the cutaneous plane is closed with the same thread with an subcutaneous stitch.
15751392|NCT04848376|Device|(1) SmartLoc (2) SmartLoc Evo (3) Winloc(4) Vigor PEEK Cervical Disc Spacer (5) Combo C (6) Polymer Lumbar Disc Spacer (7) X'Plo (8) Rainboo (9) Combo L|As long as there are patients using the above device, conduct questionnaire interview.
15751393|NCT04848363|Procedure|Quadratus lumborum block|QL block will be used for perioperative anesthesia. The blockade will be performed bilaterally by levobupivacaine (20ml) at concentration 0.25%.
15751394|NCT04848350|Other|Lavender essential oil|Aromatherapy agents were added to the nebulizer at a rate of 2% (120 ml of water).The nebulizer was prepared and operated on in the SWL room before the procedure, The patients were taken to the room 5 minutes before the procedure and the nebulizer was operated on during the procedure
15751397|NCT04848324|Other|Corticosteroid Hydrodissection|The median nerve was examined by US at the scaphoid-pisiform level of the inlet of carpal tunnel. The hydrodissection was achieved by a total volume of 3 mL (1 mL of triamcinolone and 2 mL of saline) in the intervention group based on a study identifying median nerve hydrodissection with this volume. Half of the total volume (1.5 mL ) was delivered via the in-plane ulnar approach and the other half (1.5 mL) via the in-plane median approach to create a fluid plane along the nerve.
15751398|NCT04848324|Other|Corticosteroid Injection|1 mL of triamcinolone was delivered via the in-plane ulnar approach
15751399|NCT04848311|Procedure|lymph nodes dissection at 253 station assisted by ICG|In ICG group :All patients will be subjected to laparoscopic radical resection with station 253 lymph nodes dissection by fluorescence laparoscopic.
15751435|NCT04848051|Behavioral|CRC Reminder & Short message|Participants randomized to the CRC Reminder & short message arm will receive reminder that they are due/overdue for CRC screening and short message to encourage screening
15752702|NCT04837118|Other|Resistance Training|Participate in a resistance training program
15751400|NCT04848298|Behavioral|mHealth Intervention|"The Mobile Health Arm will receive standard of care including tailored prescription of physical activity as well as the mobile health intervention, which will have the following features:
~Goal setting for frequency and duration of exercise sessions
~Graphic feedback and reinforcement with educational and motivational messages tailored to user's exercise adherence.
~Problem-solving support
~Library with educational tips and information regarding physical exercise."
15751401|NCT04848285|Other|Early Mobilization|Additional 2 or more sessions of out-of-bed activity to the standard stroke care, focused in active sitting, standing and walking assisted by physiotherapists
15751402|NCT04848285|Other|Standard care|Standard protocol of mobilization in acute stroke patients admitted to the Stroke Unit at the discretion of the nursing and physiotherapy staff
15751403|NCT04848272|Drug|Lanadelumab|Monoclonal antibody that targets active plasma kallikrein
15751404|NCT04848272|Other|Saline control|Saline control
15751405|NCT04848259|Drug|Normal saline|Saline will be applied after surgery
15751406|NCT04848259|Drug|Dexamethasone|Dexamethason will be given IV before surgery
15751407|NCT04848259|Drug|Honey|Honey will be applied locally after surgery
15751408|NCT04848259|Drug|Dexamethasone and honey|Dexamethason will be given IV before surgery and then Honey will be applied locally after surgery
15751409|NCT04848246|Drug|Bupropion|This group received Bupropion 150 mg twice daily for 10 weeks
15751410|NCT04848246|Behavioral|Behavioural Change Communication|This group will receive Behavioural Change Communication
15751411|NCT04848233|Dietary Supplement|Drinks containing 5AA+CrPic and Placebo|Same diet will be repeated for 3 days in a row and the beverage switched every day. 3 periods of 3 days are included in the study.
15751412|NCT04848220|Drug|Temanogrel|Participants will receive a single intravenous dose of temanogrel on Day 1
15751413|NCT04848220|Drug|Placebo|Participants will receive a single intravenous dose of temanogrel matching placebo on Day 1
15751414|NCT04848207|Device|Digital impression technique|3D printed generic Scan bodies with unified shape and length replacing the traditional transfer copings will be press fitted on the trans-mucosal abutments and pickup cylinders that are screwed on the implants to capture their position and intra-oral scanning will be done.
15751415|NCT04848207|Other|Open tray impression technique|"Transfer copings will be screwed to the multiunit abutments on the existing implants, and splinted together using pre-cured printed resin splinting framework that will be fixed to the copings using flowable composite .
~A one step impression technique using putty and light addition silicon will be made, where light impression material will be injected all around transfer copings and putty silicon will be loaded in tray and then will be seated intra-orally making sure to fully expose the screws of transfer copings through the impression material."
15751416|NCT04848194|Procedure|skin biopsy and blood sampling|"4 skin biopsies outside the face under local anesthesia: 2 in damaged zone, 2 in non-damage zone.
~A blood sample"
15751417|NCT04848181|Drug|cyproterone acetate|two weeks Cyproterone acetate administration before TURP
15751418|NCT04848181|Drug|finasteride|two weeks finasteride administration before TURP
15751419|NCT04848181|Drug|no treatment received|no treatment received before TURP
15751420|NCT04848155|Other|socially assistive robot|"The intervention group will work with the ReMIND-system. This ReMIND-system consists of:
~An existing socially assistive robot called James® that will be adapted based on the needs of the older adults and the robot's own functionality. For example, exercise videos and games to stimulate physical and cognitive activity will be developed and made available on the robot. The robot has to be programmed by the researcher using the ZBOS Control© application on a separate tablet that is connected to the robot.
~The Keosity-app, an application specifically designed to support people in telling, documenting and sharing their life stories with others. This application will be available on the robot."
15751421|NCT04848129|Behavioral|Feeding clinic|These children have all attended a multidisciplinary feeding clinic with severe food refusal and were commonly receiving tube feeding or supplement drinks. The clinic helps children progress onto a normal oral diet
15751422|NCT04848116|Drug|Nivolumab|Nivolumab is an investigational drug in this study.
15751423|NCT04848116|Drug|HuMax-IL8|HuMax-IL8 is an investigational drug in this study.
15751424|NCT04848116|Drug|Cabiralizumab|Cabiralizumab is an investigational drug in this study.
15751425|NCT04848103|Behavioral|Radial extracorporeal shockwave therapy|Radial extracorporeal shockwave therapy group include Therapeutic modality(Transcutaneous electrical nerve stimulation [TENS], Microwave thermotherapy, and Superficial heat therapy), Range of motion exercise(Continuous passive motion and Active range of motion exercise).
15751426|NCT04848090|Diagnostic Test|Neonate WGS Testing|"Neonates will undergo whole genome sequencing, and analysis with a targeted panel of genes likely to cause genetic disorders in the first year of life. If no diagnosis is identified, sequenced data will be analyzed using a whole exome filter. Performed in a CLIA-certified lab. Pathogenic, likely pathogenic, and VUS in genes related to the phenotype will be returned to the care team and family.
~Parents will be enrolled for the purpose of trio analysis with the child to assist in determining the pathogenicity of variants in genomic sequencing. Pathogenic and likely-pathogenic findings will be reported to the parents in the setting of genetic counseling.
~Sibling will be enrolled and have samples collected for use in the genetic analysis only if deemed essential. Results will be reported to the parents in the setting of genetic counseling."
15751427|NCT04848077|Behavioral|Step count increase with the use of a motivational smartphone application|All participants will be given access to an application installed on the participants' own smartphone: the STEPWISE app. The STEPWISE app will encourage participants to increase their long-term physical activity (1 year). Different treatment arms will receive different physical activity goals. Participants will get feedback and support via the smartphone app, that stimulates them to reach their individual physical activity goal (i.e. target percentage increase in stepcount).
15751428|NCT04848064|Drug|Cyclophosphamide|Given IV
15751429|NCT04848064|Drug|Fludarabine|Given IV
15751430|NCT04848064|Biological|Mogamulizumab|Given IV
15751431|NCT04848064|Biological|Natural Killer Cell Therapy|Given via infusion
15751432|NCT04848064|Other|Quality-of-Life Assessment|Ancillary studies
15751433|NCT04848064|Other|Questionnaire Administration|Ancillary studies
15753222|NCT04832854|Drug|Atezolizumab|Atezolizumab 1200 mg will be administered by intravenous (IV) infusion on Day 1 of each 21-day cycle.
15751436|NCT04848051|Behavioral|CRC Reminder and Navigation Program|Participants randomized to the CRC reminder and navigation program arm will receive reminder that they are due/overdue for CRC screening and short message to participate in the health navigation program that will connect participants to individually tailored resources and assistance
15751437|NCT04848051|Behavioral|CRC Reminder & CRC education|Participants randomized to the CRC reminder and CRC education program arm will receive reminder that they are due/overdue for CRC screening and offered short educational program conducted online
15751439|NCT04848025|Device|Custom-designed tracheobronchial prostheses|Computer-assisted segmentation of airways and stent from CT data (AnatomikModeling) Fabrication of a mold and then a silicon stent by mold injection and sterilization (NOVATECH) Insertion of the stent under rigid bronchoscopy and general anesthesia
15751440|NCT04848012|Device|Auto-titrating non-invasive ventilation|A non-invasive ventilator designed to auto-adjust the expiratory positive airway pressure according to expiratory flow limitation, measured using the forced oscillation technique.
15751441|NCT04847999|Dietary Supplement|Dark chocolate|Dark chocolate
15751442|NCT04847986|Behavioral|acceptance and commitment therapy (ACT)|Caregivers assigned to this intervention group will receive individual ACT sessions guided by a trained coach for one hour per week over 8 weeks through Zoom videoconferencing with psychoeducation materials provided.
15751443|NCT04847986|Behavioral|Control group|The control group will receive care as usual with psychoeducation materials provided.
15751444|NCT04847973|Other|Medically-Tailored Meals (MTMs)|12 weeks of home-delivered MTMs, delivered weekly, containing food for 3 meals per day on 5 days of the week
15751445|NCT04847960|Dietary Supplement|BioGaia Probiotic Lozenges|BioGaia Prodentis lozenges is a food supplement for oral health that contains patented lactic acid bacteria Limosilactobacillus reuteri (formerly known as Lactobacillus reuteri) Prodentis (a combination of strains of L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289) which helps good microorganisms maintain natural balance in the mouth. This product is safe for daily use and this product can be used during pregnancy and breastfeeding. The ingredients of this product are: bulking agent (isomalt), L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289, fully hydrogenated palm oil, peppermint flavoring, menthol flavoring, peppermint oil and sweetener (sucralose). One candy contains a minimum of 200 million live L. reuteri Prodentis. Net weight per candy is 800 mg. Excessive consumption can have a laxative effect due to the sweetener content in the product. This product has obtained a distribution permit in Indonesia with a BPOM number: SI194510521 with the name Probiotic Prodentis (Pro-D).
15751446|NCT04847947|Drug|Cholecalciferol|Oral capsule Cholecalciferol 4000 IU once daily and Calcium Lactate 500 mg once daily for 12 weeks
15751447|NCT04847947|Drug|Placebo|Oral capsule Placebo containing white rice flour in the same identical looking with active drug once daily and Calcium Lactate 500 mg once daily for 12 weeks
15751448|NCT04847934|Behavioral|distraction methods|distraction methods
15751449|NCT04847921|Drug|Dalbavancin|long-acting lipoglycopeptide antibacterial agent
15751451|NCT04847895|Drug|Lucentis|There is no treatment allocation. Patients administered Lucentis by prescription that have started before inclusion of the patient into the study will be enrolled.
15751452|NCT04847882|Behavioral|Questionnaire|Questionnaire submitted to the parents of children with cystic fibrosis aged 6 to 17 years and to controls in order to assess and compare the prevalence of sleep disorders and their main non-respiratory causes
15751453|NCT04847869|Device|Ellex Integre NIR laser|The Ellex Integre NIR (near Infrared Light) Laser dose of 200 mW/cm2 for 90 seconds for 12 treatments at 2 to 3 day intervals over 5 weeks.
15751454|NCT04847856|Behavioral|Diabetic care Information, education, and communication intervention will be delivered by relevant and trained health animators working in chronic care clinic.|The training sessions and the IEC materials were adapted from John Hopkins University studies on self-care for diabetic patients.
15751455|NCT04847843|Behavioral|Mindfulness Orientated Recovery Enhancement|The MORE curriculum has been adapted for this intervention to address food intake behaviors and will provide training in mindfulness techniques to increase awareness of, and self-control over, cravings; reappraisal skills to promote emotion regulation and restructure motivations for highly palatable food intake; and savoring pleasant events and emotions to overcome defects in natural reward processing.
15751456|NCT04847843|Behavioral|Control Intervention|The curriculum will be based on the Diabetes Prevention Program's Prevent T2 for Life program, which is an evidence-based national healthful lifestyle maintenance intervention. This program includes training in healthful eating, meal planning, and recipe modification; time and stress management; adapting lifestyle habits for continued success during holidays, vacations, and other special situations; and relapse prevention.
15751457|NCT04847830|Device|Er:YAG laser (Waterlase)|The WaterLase iPlus tissue cutting system is a unique device with diverse, hard- and soft-tissue dental applications. It utilizes advanced laser and water atomization technologies to safely and effectively cut, shave, contour, roughen, etch, and resect oral hard-tissue, and direct laser energy to perform oral soft-tissue removal, incision, excision, ablation and coagulation.
15751458|NCT04847830|Procedure|root surface dbridement|root surface debridement under local anaesthesia
15751459|NCT04847791|Dietary Supplement|Bovine lactoferrin|Oral Administration of Bovine Lactoferrin -fixed dose 800 mg / day for 30 days
15751460|NCT04847791|Dietary Supplement|Placebo administration|capsule identical with the same amount as an inert compound, starch of corn powder), according to the same pattern of use.
15751461|NCT04847778|Device|Use of Insulclock system, both Insulclock device and Insulclock 360 app.|"Visit 5, during week 4.
~Randomization will be applied:
~Active group will use all functionalities of Insulclock 360. They will have reminders, all their information and statistics at the disposition of the patient and healthcare providers, they have the assistance if desired of an ally or caregiver, a bolus calculator and the rest of functionalities described in the protocol."
15792579|NCT04512105|Drug|Pitavastatin|Given PO
15751462|NCT04847778|Device|Use of Insulclock system, both Insulclock device and Insulclock app on masked mode.|"Visit 5, during week 4.
~Randomization will be applied:
~Masked group will remain with the masked system, without functionalities."
15751463|NCT04847765|Device|VIPUN Gastric Monitoring System prototype|"The VIPUN Balloon Catheter prototype is a nasogastric feeding tube with integrated balloon that can be inflated with a preset volume of air. Intraballoon pressure changes are recorded outside the body. Gastric contractions can be detected in the pressure profile.
~The recording lasts 30 minutes and is combined with simultaneous cine magnetic resonance imaging."
15751464|NCT04847752|Procedure|carotid artery stenting|common treatments for carotid artery stenosis
15751465|NCT04847752|Procedure|carotid endarterectomy|common treatments for carotid artery stenosis
15751466|NCT04847752|Drug|Aspirin|the dosage and duration
15751467|NCT04847752|Drug|Clopidogrel|the dosage and duration
15751468|NCT04847752|Drug|Anticoagulant|the dosage and duration
15751469|NCT04847752|Drug|Statin|the dosage and duration
15751470|NCT04847752|Drug|PCSK9 inhibitor|the dosage and duration
15751471|NCT04847739|Procedure|Seton Placement|This treatment consists of inserting a seton (a soft flexible tube or nonabsorbable string) into the subject's perianal fistula. The seton will be removed by a study doctor at study visits as applicable.
15751472|NCT04847739|Drug|AVB-114|AVB-114 consists of stem cells taken from a subject's fat tissue seeded into a bioabsorbable plug. AVB-114 will be inserted into the subject's fistula by a study doctor on Day 0.
15751473|NCT04847726|Diagnostic Test|contrast enhanced ultrasound|contrast enhanced ultrasound with perfluorobutane and sulfur hexafluoride
15751474|NCT04847726|Diagnostic Test|Dynamic CT|Participants underwent dynamic CT for hepatic lesion
15751475|NCT04847726|Diagnostic Test|Liver MRI|Participants underwent liver MRI for hepatic lesion
15751476|NCT04847713|Other|extraction of blood samples|Two blood samples (3.5 ml each) will be collected directly into purple K2-EDTA tubes and stored at 4°C for up to 24 hours for analysis
15751477|NCT04847700|Procedure|Surgical treatment|Endoscopic retrosigmoid minimally invasive vestibular neurectomy
15751478|NCT04847700|Procedure|Surgical treatment|Endoscopic tenotomy of middle ear muscles
15751479|NCT04847687|Drug|methylprednisolone|Patients who are hospitalized with a pre-diagnosis of severe COVID-19 pneumonia and who are started on methylprednisolone will be divided into two groups according to the drug dose. Groups will be compared in terms of length of hospital stay, intensive care needs and prognosis.
15751483|NCT04847661|Drug|Mefloquine as a prophylaxis against SARS-Cov-2 infection in household contacts of COVID 19 confirmed cases|Mefloquine hydrochloride will be given in a dose of 1100-1650 mg, according to body weight (BW), splitted into two to three doses.
15751484|NCT04847648|Procedure|Air-polishing|Air-polishing with erythritol powder during non-surgical therapy (at baseline, 5 seconds per surface) and during surgical therapy(if necessary, at 6 months, 60 seconds per implant).
15751485|NCT04847648|Procedure|Mechanical decontamination|Mechanical instrumentation of implant surfaces during non-surgical therapy (at baseline) and during surgical therapy (if necessary, at 6 months) including the use of hand instruments and polishing cups aiming at the removal of all soft and hard deposits from the target implant.
15751486|NCT04847635|Device|Pascal Synthesis 577 sub-threshold laser (Topcon Corporation, Tokyo, Japan)|The subthreshold laser treatment will be performed using subthreshold laser Pascal Synthesis 577 on a customized macular area.
15751487|NCT04847635|Device|Pascal Synthesis 577 sham (Topcon Corporation, Tokyo, Japan)|The laser treatment will be performed without any power (only the light beam) using subthreshold laser Pascal Synthesis 577 on a customized macular area.
15751488|NCT04847622|Drug|Remdesivir|treated with Remdesivir
15751489|NCT04847609|Device|GentleCath™ Air catheter|Patients
15751490|NCT04847596|Other|Ofatumumab|Prospective observational cohort study. There is no treatment allocation. Patients administered Ofatumumab by prescription that have started before inclusion of the patient into the study will be enrolled.
15751491|NCT04847596|Other|Covid-19 vaccine|Prospective observational cohort study. There is no treatment allocation. Participants will obtain the COVID-19 FDA approved Emergency Use mRNA vaccine through their HCP (private insurance) or appropriate federal, state or local program.
15751492|NCT04847583|Drug|Telacebec|Telacebec 100 mg tablet
15751493|NCT04847583|Drug|COVID-19 Standard of care|The Standard of Care treatment and administration thereof will be determined by the Investigator
15751494|NCT04847570|Other|Music session|Non-clinical intervention only, and no change to clinical care or treatment. Participants will have 10 minutes of undisturbed rest, followed by a supervised music-listening session of up to 40 minutes, ending with another 10-minute rest period.
15751497|NCT04847544|Drug|ADX-629|ADX-629 administered orally twice daily (BID) for up to 28 days.
15751498|NCT04847544|Drug|Placebo|Placebo administered orally BID for up to 28 days.
15751499|NCT04847518|Drug|Kan Jang capsules|"One capsule contains a fixed combination of proprietary
~Andrographis paniculata Nees. herb, native extract, DER native 4,5-8,0 :1 260 mg (Diterpene lactones andrographolide and 14-deoxy, 11,12- didehydroadnrograholide) 15-20 mg
~Eleutherococcus senticosus (Rupr. et Maxim) Harms, root, native extract DER native 17-30:1 : 11.4 mg and other inactive excipients (Polycristalline cellulose, Magnesium stearate)."
15751500|NCT04847518|Other|Placebo capsules|Inactive excipients
15751501|NCT04847505|Diagnostic Test|68Ga-DOTA-TATE|The intervention consists of an intravenous injection of the radiopharmaceutical 68Ga-DOTA-TATE and a physiological saline flush, followed 45-90 minutes later by a PET/CT image acquisition.
15751502|NCT04847492|Procedure|Traditional corticotomy|A full-thickness mucoperiosteal flap will be elevated including the interdental papilla, and extended from the distal side of the second premolar on the right side to the same position on the left side without performing any vertical releasing incisions. Then, one vertical incision between the roots of upper anterior teeth and two vertical incisions in the site of first premolar extraction will be made by the piezosurgery knife.
15751503|NCT04847492|Procedure|Flapless corticotomy|Vertical soft-tissue incisions will be made on the buccal and palatal gingiva by using a blade N.15. One incision will be made between the roots of the six upper anterior teeth, and two incisions will be made between the upper canines and the second premolars.
15751504|NCT04847479|Behavioral|COVID-19 self-test|Up to 3 COVID-19 self-test kits will be given to individuals who have tested positive for COVID-19. Participants will be instructed to give test kits to close contacts who have been exposed to them.
15751505|NCT04847479|Behavioral|COVID-19 test referral|Text messages with testing information will be given to individuals who have tested positive for COVID-19. Participants will be instructed to share text messages with close contacts who have been exposed to them.
15751513|NCT04847440|Drug|ATI-2173|ATI-2173 is a liver-targeted phosphoramidate prodrug of clevudine designed to enhance anti-HBV activity while decreasing systemic exposure to clevudine. It will be dosed as a capsule by mouth. Viread is a nucleotide analogue reverse transcriptase inhibitor used for chronic hepatitis B virus.
15751514|NCT04847440|Drug|Viread|Viread is a nucleotide analogue reverse transcriptase inhibitor used for chronic hepatitis B virus.
15751515|NCT04847427|Other|Core exercises training|"Participants will perform:
~Squats, 4 sets of 5 repetitions at 60% 1RM
~Deadlifts, 4 sets of 5 repetitions at 60% 1RM
~Lunges, 4 sets of 5 repetitions at 60% 1RM
~Step ups, 4 sets of 5 repetitions at 60% 1RM"
15751516|NCT04847427|Other|Structural exercises training|"Participants will perform:
~Snatch, 4 sets of 5 repetitions at 60% 1RM
~Hang clean, 4 sets of 5 repetitions at 60% 1RM
~Push jerk, 4 sets of 5 repetitions at 60% 1RM
~Split push jerk, 4 sets of 5 repetitions at 60% 1RM"
15751517|NCT04847427|Other|Accentuated eccentric exercises training|"Participants will perform:
~Deadlifts - squat jump, 4 sets of 5 repetitions at 30% body mass (BM)
~Step down - squat jump, 4 sets of 5 repetitions at 30% BM
~Step down - lunges, 4 sets of 5 repetitions at 30% BM
~Bulgarian squat jumps, 4 sets of 5 repetitions at 30% BM"
15751518|NCT04847427|Other|Control trial|Participants will perform all the measurements that are comprised in the experimental conditions without performing any exercise protocol
15751519|NCT04847414|Diagnostic Test|HbA1C, other investigations|we will do some necessary investigations for prospective group
15751520|NCT04847401|Diagnostic Test|H. pylori stool antigen|using H. pylori antigen kits in stool
15751521|NCT04847388|Drug|Substance like alcohol, marijuana, etc.|Cohort study
15751522|NCT04847375|Drug|exogenous surfactant|Nebulized Surfactant would be administered by face mask which has a nebulizer
15751523|NCT04847362|Behavioral|Experimental|education group
15751524|NCT04847349|Dietary Supplement|OL-1, standard dose|The live microbial components have been present in the food supply, have a long history of safe use in foods, and are already marketed in the United States.
15751525|NCT04847349|Dietary Supplement|OL-1, high dose|The live microbial components have been present in the food supply, have a long history of safe use in foods, and are already marketed in the United States.
15751526|NCT04847349|Dietary Supplement|Placebo|Capsule containing inactive ingredients such as a product of potato starch (maltodextrin), but no probiotics.
15751527|NCT04847336|Other|No intervention is planned|No intervention is planned
15751528|NCT04847323|Device|V-bend Bonded Retainer|Traditional stainless steel retainer commonly bonded in the anterior teeth of the mandibular arch to maintain their alignment after orthodontic treatment.
15751529|NCT04847323|Device|Vacuum-formed Retainer|Removable retainers made of plastic and derivatives. Currently gaining popularity due to the increased use of esthetic aligners. These clear retainers have the objective to maintain stable the results obtained after orthodontic treatment. They cover all the surfaces of the teeth up to the first or second molars.
15751530|NCT04847310|Other|Transdiagnostic group psychotherapy|"Brief transdiagnostic group psychotherapy focused on the emotion regulation strategies that maintain the emotional symptoms. Seven 90-minute sessions in 12-16 weeks with 8-10 participants per group. Provided by a clinical psychologist.
~Described by Cano-Vindel et al. (2016), an adaptation of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (Barlow et al., 2011) and the Improving Access to Psychological Therapies (IAPT) program (Clark, 2011)."
15751531|NCT04847310|Other|Transdiagnostic individual psychotherapy|An adaptation to individual format of the group intervention. From 2 to 8 sessions of 30-60 minutes. Provided by a clinical psychologist.
15751532|NCT04847310|Other|Treatment as usual (TAU)|Mainly pharmacological treatment prescribed by the general practitioner (GP). If the GP recommended psychotherapy as part of the TAU, the participant would be excluded to avoid bias.
15751533|NCT04847297|Procedure|Preoperative drainage and pancreatoduodenectomy|Preoperative biliary drainage before surgical removal of the tumor
15751534|NCT04847297|Procedure|Pancreatoduodenectomy|Pancreatic tumor resection without previous preoperative biliary drainage
15751535|NCT04847284|Radiation|Intraoperative radiotherapy|Intraoperative radiotherapy application immediately following resection of brain metastases.
15751536|NCT04847271|Behavioral|Physical activity on prescription (PAP)|The intervention in this study will comprise the 3 PAP components. Participants will take part in all components and perform one or several physical activities of their choice in accordance to the written prescription, at the prescribed frequency and duration, for a period of 4 months.
15751537|NCT04847258|Other|Standard rehabilitation|Patients follow standard municipal rehabilitation
15751538|NCT04847245|Drug|Pregabalin 75mg tid + Duloxetine|Pregabalin capsules were administered orally (75 mg, 3 times a day), combined administration of duloxetine (60-120 mg/day）.
15754329|NCT04823442|Drug|Bisoprolol Fumarate|a single dose of 10 mg (2 tablets of 5 mg)
15751539|NCT04847245|Drug|Intravenous administration of esketamine 0.125 mg/kg+Duloxetine|Intravenous administration of esketamine 0.125 mg/kg （2 times per week)， combined oral administration of duloxetine (60-120 mg/day）
15751540|NCT04847245|Drug|Intravenous administration of esketamine 0.25 mg/kg +Duloxetine|Intravenous administration of esketamine 0.25 mg/kg （2 times per week)， combined oral administration of duloxetine (60-120 mg/day）
15751541|NCT04847245|Drug|Intravenous administration of esketamine 0.50 mg/kg+Duloxetine|Intravenous administration of esketamine 0.50 mg/kg （2 times per week)， combined oral administration of duloxetine (60-120 mg/day）
15751544|NCT04847219|Device|Professional flash glucose mornitoring|Subjects will use Professional flash glucose mornitoring once a month for 3 months.
15751545|NCT04847219|Device|Personal flash glucose mornitoring|Subjects will use Personal flash glucose mornitoring once a month for 3 months.
15751546|NCT04847206|Drug|3,4-methylenedioxymethamphetamine|A moderate dose of 100 mg MDMA will be administered.
15751547|NCT04847206|Drug|3,4-methylenedioxyamphetamine|A moderate dose of 93.9 mg MDA will be administered.
15751548|NCT04847206|Drug|lysine-3,4-methylenedioxymethamphetamine|A moderate dose of 171.7 mg lysine-MDMA will be administered.
15751549|NCT04847206|Drug|lysine-3,4-methylenedioxyamphetamine|A moderate dose of 165.6 mg lysine-MDA will be administered.
15751550|NCT04847206|Other|Placebo|Placebo (Mannitol)
15751551|NCT04847193|Other|Dietary Intervention 1: Placebo|Participants receive a study drink supplemented with a placebo for 5 days
15751552|NCT04847193|Other|Dietary Intervention 2: Xanthohumol and Iso-alpha acids|Participants receive a study drink supplemented with xanthohumol, Iso-alpha acids or a combination of both for 5 days
15751553|NCT04847180|Procedure|Biopsy|The biopsy will be performed at the level of the capsular fold located just above the area devoid of cartilage in the postero-superior region of the humeral head, near the area where Hill Sachs notches occur.
15751554|NCT04847167|Procedure|Single balloon enteroscopy assisted ERCP using a mechanistic loop resolution strategy group|The SBE was introduced alternately with an overtube apparatus (ST-SB1S; Olympus Corp., Japan) following the mechanistic loop resolution strategy under endoscopic and fluoroscopic guidance. The overtube was advanced along the enteroscope, by gently pulling the enteroscope, like as ERCP accessory advancement over the guidewire.
15751555|NCT04847141|Biological|C19-IG 20%|Anti-COVID-19 Immune Globulin (Human) 20%
15751556|NCT04847141|Drug|0.9% Sodium chloride|C19-IG 20% matching placebo
15751557|NCT04847128|Behavioral|Chronic aerobic exercise|Participants in the experimental group will exercise more than 30 minutes each time and 3 times weekly for 8 weeks. The way to exercise is required for running. Participants must reach the speed when their heart rate is more than 60 percent of maximum heart rate.
15751558|NCT04847115|Procedure|Operative|Intramedullary screw fixation
15751559|NCT04847115|Other|Walking boot orthosis|Non-operative treatment with walking boot orthosis for six weeks. The non-operative study arm will use walking boot orthosis only. The operative study arm will use walking boot orthosis as adjuvant treatment.
15751560|NCT04847102|Biological|SARS-CoV-2 mRNA Vaccine|"The SARS-CoV-2 mRNA Vaccine is formulated by encapsulating the mRNA, which encodes the receptor-binding domain (RBD) of spike glycoprotein (S protein) of SARS-CoV-2 and is transcribed in-vitro by the corresponding DNA template, in lipid nanoparticles (LNPs). This vaccine is presented as a white to off-white dispersion for injection.
~Active substances: mRNA encoding the RBD of the S protein of SARS-CoV-2.
~The vaccine is supplied in single-dose pre-filled syringe with 0.5 mL dispersion for intramuscular injection. Each dose (0.5 mL) of the vaccine contains:
~15 μg of mRNA encoding the RBD of the spike glycoprotein (S protein) of SARS-CoV-2, 0.339 mg of total lipids (including lipid 9001, cholesterol, DSPC, DMG-PEG2000)."
15751561|NCT04847102|Biological|Placebo|0.9% sodium chloride solution, 0.5 mL/vial
15751562|NCT04847089|Device|Motor imagery BCI training|Motor Imagery (MI)-BCI training, 2-3 hours, 3 times/week for 4 weeks.
15751563|NCT04847076|Behavioral|m-health version of WWWT intervention|m-health version of Chilean adaptation of WWWT intervention: a) Psychoeducational information for understanding and managing infant behavior and on parenting. b) Contact with the program facilitator. c) A virtual group meeting
15751564|NCT04847076|Other|Treatment as usual|TAU for children under one year of age include routine health checks by health professionals (nurse or doctor), every month from 0 to 4 months of age, and at 6, 8 and 12 months of age
15754606|NCT04821063|Drug|Placebo|Dose: 20 mL; Dosage form: suspension; Route of administration: oral
15751572|NCT04847050|Biological|mRNA-1273|A rapid response, proprietary messenger RNA (mRNA)-based vaccine platform. 100 mcg administered IM on Day 1 and 29
15751573|NCT04847037|Procedure|Connected tools|Use of connected tools in postoperative bariatric follow-up vs no use of connected tools.
15751574|NCT04847024|Drug|Parecoxib|40 mg IV
15751575|NCT04847024|Drug|Dexketoprofen|50 mg IV
15751576|NCT04847011|Other|Fasting|Patients undergo a 5-10 day fasting period with a dietary energy supply 350-400kcal per day with fruit and vegetable juices or, if not feasible, an established fasting-mimicking diet of 600-800 kcal according to Longo et al.
15751577|NCT04846998|Drug|BR9003|"Treatment group B:
~Once-daily oral administration of one BR9003 2mg tablet in the fasting state.
~Treatment group C:
~Once-daily oral administration of one BR9003 2mg tablet after a meal(high-fat meal) 30 minutes before the scheduled time of administration and finishing it."
15751578|NCT04846998|Drug|BR9003A|"Treatment group A:
~Twice-daily oral administration of one BR9003A 1mg tablet in the fasting state"
15751579|NCT04846972|Behavioral|FASTRACS intervention|"Intervention (4 steps) :
~Penultimate to last chemotherapy : patient will receive tools of the intervention
~1 month after the end of oncological treatment (OT): patient will attend a general medicine consultation with the GP RTW checklist
~2 months after OT: patient will attend a pre RTW visit with the OP RTW checklist
~5 months after the end of OT: if the patient has not returned to work 10 months after inclusion, they will have a visit with an OP-RTW to work coordinator
~Self-questionnaires will evaluate quality of life (EORTC QLQC30, BR23, Euroqol (EQ-5D-5L)), anxiety and depression (HAD), employment status, self-efficacy to return to work (RTW-SE11), pre-RTW and RTW visit with the OP, social support, care consumption, physical activity (short IPAQ), perceived performance (WRF), work conditions. The implementation and use of the intervention tools will also be assessed: the patient guide, the employer guide, RTW checklists for the GP and the OP."
15751580|NCT04846959|Drug|Risankizumab|Subcutaneous Injection
15751581|NCT04846959|Drug|Comparator|Subcutaneous or Intravenous Injection
15751582|NCT04846946|Behavioral|Hey, Friend|"Intervention in development. However, we will use intervention mapping and the designing for dissemination approach, informed by self-reported qualitative data, to develop the Hey, Friend modules. The mHealth intervention will include three modules that include multiple sub-topics (e.g., What is HIV?; How do I protect myself from HIV?; What is PrEP?, etc.), deliver culturally appropriate counseling content in community settings, juvenile court system, clinics, and schools; will include Motivational Interviewing components that are effective in evoking behavior change while being acceptable to adolescents and parents, and will include ongoing support through a text reminder to maximize the likelihood of initiating HIV prevention through testing and PrEP."
15751583|NCT04846933|Genetic|WGS and RNA sequencing|
15751584|NCT04846933|Genetic|circulating tumor DNA (ctDNA)|
15751585|NCT04846933|Diagnostic Test|FDG PET/CT imaging|
15751587|NCT04846907|Other|Web-based survey|Eligible participants received emails or text messages with links to a REDCap-created and managed web-based questionnaire
15751588|NCT04846894|Diagnostic Test|Ga-68 PSMA-11 PET/CT imaging|Sequential PET/CT imaging using analog and digital PET/CT scanners after single intravenous injection of Ga-68 PSMA-11
15751593|NCT04846855|Drug|local anaesthetic injection|Realization by the anesthesiologist of the local anesthesia by single dose of ropivacaine 0.35% in perinervous under ultrasound with distraction by a tablette.
15751594|NCT04846842|Drug|Gimatecan|Patients will receive gimatecan orally at the fixed dose level on day 1-5 every 4 weeks.
15751595|NCT04846829|Drug|Placebo|saline PBO will be administered intravenously using established clinical procedures. A single dose if saline PBO will be delivered intravenously under double-blind conditions via pump over a 40-minute period.
15751596|NCT04846829|Device|intermittent theta burst stimulation|"10 sessions of treatment with cTBS to right DLPFC TBS consists of three TMS pulses given at 50 Hz, with this triplet repeated at a frequency of 5 Hz (every 200 ms).
~iTBS paradigm of a 2 s train repeated every 10 seconds"
15751597|NCT04846829|Drug|intravenous citalopram hydrochloride (CIT)|CIT will be administered intravenously using established clinical procedures. A single 40 mg dose of CIT diluted in 60 cc normal saline will be delivered intravenously under double-blind conditions via pump over a 40-minute period.
15751598|NCT04846829|Device|continuous theta burst stimulation|"10 sessions of treatment with iTBS to left or cTBS to right DLPFC TBS consists of three TMS pulses given at 50 Hz, with this triplet repeated at a frequency of 5 Hz (every 200 ms).
~1800 pulses of cTBS will be delivered"
15751599|NCT04846816|Combination Product|SQIN-01|The drug and device combination is called SQIN-01. SQIN-01 is a combination of SQIN-Infusor and SQIN-Furosemide Investigational pump (SQIN-Infusor, medical device) intended for subcutaneous infusion of investigational product, SQINFurosemide.
15751600|NCT04846803|Biological|ABU bladder lavage|Clinical effect of preventive treatment (prophylactic treatment) - bladder lavage with the non-pathogenic bacterial strain (ABU)
15751601|NCT04846803|Biological|Saline bladder lavage|Clinical effect of preventive treatment (prophylactic treatment) - bladder lavage with saline
15751602|NCT04846790|Behavioral|Nature Only|See above for description.
15751603|NCT04846790|Behavioral|Nature+Mindfulness|See above for description.
15751604|NCT04846777|Device|Mindfulness ecological momentary intervention|Access to a smartphone-delivered mindfulness ecological momentary intervention with the Personal Analytics Companion (PACO) app that regularly prompts participants to practice various mindfulness skills at 5 preset times each day.
15754735|NCT04819906|Drug|Moxifloxacin 400 mg|One moxifloxacin 400 mg tablet orally once (open-label)
15751605|NCT04846777|Device|Self-monitoring placebo|Access to a smartphone-delivered self-monitoring placebo with the PACO app that regularly prompts participants to practice self-monitoring at 5 preset times each day.
15751606|NCT04846764|Other|Neuropsychological tests|"Scales and tests to evaluate:
~laterality
~anxiety
~depression
~professional level
~education level
~pre-morbid level
~memory disorders
~Experimental procedure"
15751607|NCT04846751|Behavioral|TYPE OF EXERCISE (OR REST)|continous exercise in normal temperature, continous exercise in hot environment, intervallic exercise in normal temperature.
15751608|NCT04846738|Device|Transcranial Doppler|This device measures Mean Systolic Velocity (VMS), Tele-Diastolic Velocity (TDV) and Pulsatility Index (PI),
15751609|NCT04846738|Device|Pupillometry.|This device measures the photomotor reflex (basic pupil diameter, percentage of variation, latent and slope of the standard photomotor reflex)
15751610|NCT04846725|Other|Data collection|"Collect in medical records :
~Filter's retrieval rate
~Complications of vena cava filters
~Predictive factors of attempted inferior vena cava filters retrieval: age, the distance between the patient's home and the hospital, the indication or not given by the therapeutic medicine department, patients referred by external structures, patients whose filter was installed during the medical on-call period, the absence of a written request for filter placement, the presence of active neoplasia at the time of filter placement, a peri-surgical context."
15751611|NCT04846712|Other|Collect data of medical record|Collect data of medical record: initial physical examination, ultrasound (US), Magnetic Resonance Imaging (MRI), physical examination at 15, 30 days, physical examination at 3 months, physical examination at 6 months and final examination at 12 months.
15751612|NCT04846699|Procedure|per-cutaneous stone extraction|percutaneous nephrolithotripsy for renal stones by different renal access
15751613|NCT04846686|Biological|Placenta pathological examination|a placenta pathological examination will be analyzed to examine quantification of EG-VEGF, PROKR1 and PROKR2 receptors.
15751614|NCT04846673|Drug|Pregabalin 150mg + Alpha-lipoic acid 480mg|Pregabalin qd + alpha-lipoic acid qd
15751615|NCT04846673|Drug|Pregabalin 150mg|pregabalin qd
15751616|NCT04846673|Drug|Alpha-Lipoic Acid 480mg|alpha-lipoic acid qd
15751617|NCT04846660|Other|Production pressure|Participant exposed to production pressure
15751618|NCT04846647|Behavioral|unexplained hypophoshatemia|Collection of additional blood volume (approximately 10 mL) during blood tests provided as part of the usual medical care.
15751619|NCT04846634|Drug|Penpulimab+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel|A cycle of treatment is defined as 21 days of once daily treatment.
15751620|NCT04846634|Drug|Penpulimab+Anlotinib+Cisplatin/Carboplatin+Pemetrexed/Paclitaxel/Gemcitabine/Docetaxel|A cycle of treatment is defined as 21 days of once daily treatment.
15751621|NCT04846634|Drug|Penpulimab+Anlotinib|A cycle of treatment is defined as 21 days of once daily treatment.
15751622|NCT04846621|Drug|Potassium Channel Opener|Randomized Controlled comparative clinical trial between two drugs as a tocolytic agent in preterm labor
15751623|NCT04846621|Drug|Calcium channel blocker|Randomized Controlled comparative clinical trial between two drugs as a tocolytic agent in preterm labor
15751624|NCT04846608|Other|Observation|Observation
15751625|NCT04846595|Other|self questionnaire|Evaluate the demographic variables and medical characteristics of people living with HIV in the Alpine Arc region
15751626|NCT04846569|Behavioral|Transition Theory-based Intervention|The behavioral intervention is a theoretically driven curriculum focused on supporting mothers from pregnancy through postpartum in order to promote sustained HIV treatment adherence. Sessions utilize motivational interviewing and consist of a range of topics including motherhood, preparing for baby, disclosure, HIV education, adherence, birth experiences, support systems, and living positively.
15751627|NCT04846569|Behavioral|Enhanced Standard of Care Control|In addition to standard of care, participants receive the first session of the Transition Theory-based Intervention curriculum which focuses on motherhood and preparation for baby but does not discuss the transition from pregnancy to postpartum or the postpartum period.
15751628|NCT04846556|Other|data collection|data collection : gender, weight, biological data (platelets, hemoglobin, creatinine, liver function tests), performance status, type of Venous Thromboembolic Event (VTE) and cancer, anticancer and anticoagulant therapy, adverse events (bleeding, recurrence of Venous Thromboembolic Event (VTE), death) up to 6 months after their Venous Thromboembolic Event (VTE).
15751629|NCT04846543|Other|MRI Scan|MRI scan
15751631|NCT04846517|Device|Transcranial Magnetic Treatment|"iTBS treatment: Trains of 50 Hz pulses every 200 ms lasting 2 s, with an 8 s intertrain interval (ITI), repeated 60 times 1800 total pulses each day Treatment Duration: 9 minutes Location: Left DLPFC
~LF-rTMS treatment: Delivered immediately after iTBS treatment as described above.
~SMA will involve a continuous train of 1 Hz stimulation for a total of 1200 pulses lasting 20 minutes Treatment Duration: 20 minutes Location: SMA"
15751914|NCT04844086|Biological|RPM CD19-mbIL15-CAR-T cells|"Single dose of RPM CD19-mbIL15-CAR-T cells will be infused, and a standard 3+3 design will be applied.
~Drug: Fludarabine
~Fludarabine is used for lymphodepletion.
~Drug: Cyclophosphamide
~Cyclophosphamide is used for lymphodepletion"
15751636|NCT04846491|Drug|Peginterferon alfa-2b injection|Peginterferon alfa-2b injection (high dose) will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 week a cycle, up to 12 cycles (144 weeks) at most. TDF will be taken orally during the whole treatment period. And then followed for 24 weeks after treatment.
15751637|NCT04846491|Drug|Peginterferon alfa-2b injection|Peginterferon alfa-2b injection (low dose) will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 week a cycle, up to 12 cycles (144 weeks) at most. TDF will be taken orally during the whole treatment period. And then followed for 24 weeks after treatment.
15751638|NCT04846491|Drug|TDF|Patients will take TDF orally for the first 48 weeks, and then one can choose to continue the single-TDF treatment up to 144 weeks, or may choose to change to receive peginterferon alfa-2b combined TDF therapy for the later 96 weeks, peginterferon alfa-2b will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 weeks a cycle. And then followed for 24 weeks after treatment.
15751639|NCT04846491|Drug|Peginterferon alfa-2b injection|Peginterferon alfa-2b injection will be weekly subcutaneous injected for 8 weeks and then stop for 4 weeks, 12 week a cycle, up to 12 cycles (144 weeks) at most. TDF will be taken orally during the whole treatment period. And then followed for 24 weeks after treatment.
15751640|NCT04846478|Drug|Talazoparib|capsule, taken by mouth, once a day
15751641|NCT04846478|Drug|Tazemetostat|orally as a tablet twice daily.
15751642|NCT04846465|Other|Screening in picture archiving and communication system (PACS) .|Screening in picture archiving and communication system (PACS) , the images of the participants who underwent computed tomography (CT) of the femur and acetabulum.
15751643|NCT04846452|Drug|Sintilimab + Anlotinib + Pemetrexed + Cisplatin or Carboplatin|Patients with non-squamous NSCLC will receive sintilimab, anlotinib hydrochloride, pemetrexed, and cisplatin or carboplatin.
15751644|NCT04846452|Drug|Sintilimab + Anlotinib + Albumin Paclitaxel + Carboplatin|Patients with squamous NSCLC will receive sintilimab, anlotinib hydrochloride, albumin paclitaxel, and carboplatin.
15751646|NCT04846413|Other|Speech task|Speech task which consists of a sustained emission of the vowel /e/.
15751647|NCT04846400|Device|ssNPA|The ssNPA is a self-supporting nasopharyngeal airway, a stent that is a non-surgical alternative to treat severe OSA
15751648|NCT04846387|Diagnostic Test|Magnetic Resonance Imaging (MRI)|"A T1-weighted Anatomical Image, Diffusion Weighted Image, and functional MRI (fMRI) of empty bladder image will be obtained.
~Additionally, fMRI image during full bladder state and voiding/holding tasks will be obtained."
15751649|NCT04846387|Diagnostic Test|Post-Void Residual|The patient's post-void residual is determined using a portable ultrasound machine after emptying the bladder just prior to entering the MRI scanner and immediately after the MRI scan.
15751650|NCT04846387|Diagnostic Test|Uroflowmetry|Patients will urinate into a funnel connected to an electric flow meter to record urine flow rates in mililters per second. This is used as part of the screening process.
15751651|NCT04846387|Behavioral|Questionaire - AUA Symptom Score|Subjects will fill out questionnaire asking about urinary symptoms. The range is 0-35.
15751652|NCT04846374|Device|PowerPort|The study will compare pheresis sessions with the old system versus pheresis sessions with one of two new configurations.
15751653|NCT04846361|Other|Vaginal hygiene wash|vaginal hygiene wash containing Propylene Glycol, Ethylhexylglycerin, Lactic Acid, Sodium Pyrrolidone Carboxylic Acid, Alpha-Glucan Oligosaccharide, Lactococcus Ferment Lysate, Octenidine Hydrochloride plus all other ingredients in placebo wash
15751654|NCT04846361|Other|placebo wash|placebo wash containing water, disodium cocoamphodiacetate, sodium chloride, sodium glycolate, acrylates copolymer, potassium laureate phosphate, tripotassium phosphate, laurel glucoside, lauramidopropyl hydroxysultaine, disulfonate de sodium, Polyethylene glycol (PEG)-120 Methyl Glucose Trioleate, Propanediol, Glycol distearate, Laureth-4, Cocamidopropyl betaine, Potassium Lactate, Caprylyl Glycol, Disodium ethylenediaminetetraacetic acid (EDTA), Potassium Hydroxide, and Perfume
15751655|NCT04846348|Combination Product|Topical preparation of sodium cromolyn 5%, diphenhydramine 1% and trolamine salicylate 10% in emollient cream base.|Combination of ingredients includes 2 agents which target mast cell mediators and one agent which globally reduces mast cell degranulation combined in an emollient cream base (Vanicream).components: Vanicream: Over the counter emollient cream Diphenhydramine Antihistamine Trolamine salicylate Prostaglandin inhibitor, antiinflammatory Cromolyn Sodium Mast cell degranulation inhibitor
15751656|NCT04846335|Drug|Doxycycline Hcl|tablets of DOXY hydrocloride (Bassado)
15751657|NCT04846335|Drug|Placebo|tablets of placebo
15751658|NCT04846322|Diagnostic Test|PD4ED 3-step intervention (ED assessment, outpatient assessment, Brain health plan)|"ED assessment for suspected dementia.
~positive ED patients referred for outpatient clinic cognitive impairment assessment.
~positive clinic patients referred to primary care with brain health patient plan."
15751659|NCT04846309|Radiation|Radiation|Prior to the start of study therapy, eligible subjects will receive a FMISO-PET scan. If there is uptake visualized on the scan, the tumor will be considered as hypoxic. If there is no uptake seen on the FMISO-PET scan, tumors will be labeled not hypoxic. Subjects with tumors identified by imaging as hypoxic will be treated with a higher dose of radiation therapy. Tumors will be defined as being hypoxic if FMISO accumulation occurs as demonstrated by SUV uptake in the tumor.
15751660|NCT04846309|Drug|FMISO PET CT|Prior to the start of study therapy, eligible subjects will receive a FMISO-PET scan. If there is uptake visualized on the scan, the tumor will be considered as hypoxic. If there is no uptake seen on the FMISO-PET scan, tumors will be labeled not hypoxic.
15751915|NCT04844073|Drug|MVC-101|CD3 engaging conditionally active bispecific protein binding EGFR and CD3
15751661|NCT04846296|Other|Questionnaire|The QLPSD, developed in Spain, was the first questionnaire designed to evaluate HRQoL in adolescents with spinal deformities. It has shown good validity and reliability. English, French and Persian versions of the QLPSD have been developed and validated. Good reliability and ease of use are mentioned in these versions. The QLPSD was designed to examine adolescents with spinal deformities and measure the effect of orthotic and surgical treatments on QoL.
15751662|NCT04846283|Procedure|Elective or emergency colorectal surgery for cancer, diverticular disease, inflammatory bowel-disease or reversal of Hartmann's procedure|We considered all the procedures that required an intestinal anastomosis in colo-rectal surgery
15751663|NCT04846270|Device|TENA SmartCare Change Indicator|Each participating subject will be provided with TENA SmartCare Change Indicator and incontinence products for the duration of the investigation. Each participating subject will be allocated to the incontinence type(s) that are considered most suitable.
15751664|NCT04846257|Other|Dynamic contrast-enhanced MRI|Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) is the acquisition of sequential images during the passage of a contrast agent within a tissue of interest.
15751665|NCT04846231|Dietary Supplement|Fish Oil, Cinnamon, Garlique,Turmeric, Plant Sterol, Red Yeast Rice|Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).
15751666|NCT04846231|Drug|Rosuvastatin|Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).
15751667|NCT04846231|Other|Placebo|Subjects will be randomized to a Statin (Rosuvastatin 5 mg), a placebo, or a dietary supplement (Fish oil, Cinnamon, Garlic, Turmeric, Plant sterol, Red yeast rice).
15751668|NCT04846218|Drug|hCG|
15751669|NCT04846218|Drug|Progesterone|
15751670|NCT04846218|Drug|Triptorelin|
15751671|NCT04846205|Diagnostic Test|systematic etiological|"Theses following tests are made as usual practice :
~Ventilator polygraphy, or polysomnography between 1 month and 1 year after cryptogenic ischemic stroke.
~Transoesophageal ultrasound"
15751672|NCT04846192|Other|Nutritional evaluation|Collecting existing data on pre operative nutritional status and outcomes after surgery
15751673|NCT04846179|Dietary Supplement|Ginkgo biloba extract|Patients recruited to Ginkgo Biloba Extract (GBE) group will be advised to take Webber Natural Ginkgo Biloba 120 mg soft gel, 1 tablet twice a day for 4 months.
15751674|NCT04846166|Diagnostic Test|Periodontally healthy group|probing pocket depth (PPD)≤ 3 mm (presence of normal gingival sulcus), bleeding on probing (BOP) < 10%, clinical absence of periodontal inflammation, radiological bone loss, and any prior periodontal disease, additionally presence of anatomically intact periodontium
15751675|NCT04846166|Diagnostic Test|Periodontitis|: interdental clinical attachment level (CAL) ≥ 5 mm and PPD ≥ 6 mm on at least two non-adjacent teeth, bone loss involving the middle or apical third of the root radiographically, moderate ridge defect and ≥30% of teeth
15751676|NCT04846153|Other|Human-based Quantification of Airway Stenosis|Human-based Quantification of Airway Stenosis From Bronchoscopic Images.
15751677|NCT04846153|Device|Computer-based Quantification of Airway Stenosis From Bronchoscopic Images.|Computer-based Quantification of Airway Stenosis From Bronchoscopic Images.
15751680|NCT04846114|Procedure|Dental implant surgery|
15751681|NCT04846101|Other|OMNISHADE|Anterior dental cavities (Class III, Class IV) will be restored with an omnishade composite material
15751682|NCT04846101|Other|MULTISHADE|Anterior dental cavities (Class III, Class IV) will be restored with conventional multishade composite material.
15751683|NCT04846101|Diagnostic Test|Instrumental Shade Analysis|Assessment will be performed by single operator using spectrophotometer (EASYSHADE) to detect color difference between tooth and restoration
15751684|NCT04846101|Other|Visual Shade Analysis|Visual assessment will be performed by two calibrated specialists to evaluate shade matching between the tooth and restoration
15751685|NCT04846101|Other|Patient satisfaction|Patient satisfaction of the final shade match will be assessed on a visual analogue scale
15751686|NCT04846088|Other|Product A|A 4mg nicotine pouch product
15751687|NCT04846088|Other|Product B|A 7mg nicotine pouch product
15751688|NCT04846088|Other|Product C|A 7mg nicotine pouch product
15751689|NCT04846088|Other|Product D|A 7mg nicotine pouch product
15751690|NCT04846088|Other|Product E|A 7mg nicotine pouch product
15751691|NCT04846088|Other|Product F|A 7mg nicotine pouch product
15751692|NCT04846088|Other|Product G|A 7mg nicotine pouch product
15751693|NCT04846088|Other|Product H|A 7mg nicotine pouch product
15751694|NCT04846088|Other|Product I|A 7mg nicotine pouch product
15751695|NCT04846075|Behavioral|Ramadan fasting, praying, and welfare for poor|Abstaining from food, drink, smoking, and sexual activity duirng daytime; ritualistic praying at specific time of a day for five or more times; volunteering for communities or donation
15751696|NCT04846062|Behavioral|nutrition behavior intervention|Iodized salt utilization and iron dietary intake behavior
15751697|NCT04846049|Other|Comprehensive Care|"Comprehensive Geriatric Assessment (3 visits with a geriatrician alternating with 3 primary provider visits over 6 months)
~Care Planning with Interdisciplinary Team
~Care coordination
~Co-management with Primary care
~Social work needs assessment
~Patient-centered telehealth using phone, home telehealth, patient portal, Video
~Transportation provided for all visits
~Referral to Geriatric primary care clinic and mental health per Veteran need
~Goals of Care and Veteran preferences conversation
~Educate primary care providers about HNHR population, home and community based services, collaboration"
15751698|NCT04846049|Other|Standard Care|No intervention or treatment will be provided.
15751701|NCT04846023|Device|aEEG via vEEGix|Amplitude-Integrated EEG can be achieved with a limited number of frontal electrodes. There is a new aEEG technology available: VEEGix, developed by NeuroServo Inc. It is a miniaturized aEEG, non-intrusive, portable and resistant to patient's movements. Its main advantage is its simplicity of use as a single adhesive strip including all electrodes is fixed to the patient's forehead and is connected to the VEEGix device
15751702|NCT04846010|Combination Product|PurWet|(1) cang zhu (Atractylodis Rhizoma), bai (zhu Atractylodis macrocephalae Rhizoma), dang shen (Codonopsis Radix), huang qi (Astragali Radix), Fu ling (Poria), Zhu ling (polyporus), Ze xie (Alismatis Rhizoma), Yi yi ren (Coicis Semen), gan cao (Glycyrrhizae Radix),
15751703|NCT04846010|Combination Product|FurFat|(2).shan zha (Crataegi Fructus), Jue Ming Zi (Cassiae Semen), He ye (Nelumbinis Folium), Da huang (Rhei Radix et Rhizoma), Ze xie (Alismatis Rhizoma), dan shen ( Salviae miltiorrhizae Radix).
15751704|NCT04846010|Combination Product|PurApo|(3)Sheng Di Huang (Rehmanniae Radix), Xuan Shen (Scrophulariae Radix), mai men dong (Ophiopogonis Radix), shan zhu yu (Corni Fructus), shan yao (Dioscoreae Rhizoma), sha yuan zi (Astragali complanati Semen), ci ji li (Tribuli Fructus), nu zhen zi (Ligustri lucidi Fructus)
15751705|NCT04846010|Combination Product|PurPhl|(4) chen pi (Citri reticulatae Pericarpium), hua ju hong (Citri grandis Exocartium rubrum), zhi shi (Aurantii Fructus immaturu), zhi ban xia (Pinelliae Rhizoma preparatum), zhi tian nan xing (Arisaematis Rhizoma preparatum),sha ren (Amoni Fructus), Gua lou (Trichosanthis Fructus), Chuan bei mu ( Fritillatiae cirrhosae Bulbu), Fu ling ( Poria), Da huang ( Rhei Radix et Rhizoma).
15751706|NCT04846010|Combination Product|PurClo|(2) Dan shen (Salviae miltiorrhizae Radix), Yu jin (Curcumae Radix), chi shao (Paeoniae Radix rubra), tao ren (Persicae Semen), hong hua (Carthami Flos)
15751707|NCT04846010|Combination Product|PurInf|(1) lei gong teng (Tripterygii wilfordii Radix), Huang Qin (Scutellariae Radix), Huang Lian (Coptidis Rhizoma), Huang Bai (Phellodendri Cortex), Zhi Zi (Gardeniae Fructus).
15751708|NCT04846010|Combination Product|Smoliv|(2). Vagus never communicates with LES: yu jin (Curcumae Radix), Chai Hu (Bupleuri Radix), chi shao (Paeoniae Radix rubra), Mu Dan Pi (Moutan Cortex), chuan lian zi (Toosendan Fructus), long gu (Fossilia Ossis Mastodi), mu li (Ostreae Concha)
15751709|NCT04845997|Biological|COVID-19 Vaccine|Patients with rheumatic diseases who have been vaccinated for COVID-19
15751710|NCT04845971|Dietary Supplement|Saisei Maf capsules|Dietary supplement name: Colostrum MAF, Saisei MAF immunomodulator. Formulation: 148 mg acid-resistant coated capsules, containing 2.3 mg of enzymatically treated bovine colostrum powder and supplementary ingredients The dietary supplement substances: Active ingredien: Enzymatically treated bovine colostrum powder 2.3 mg 1.6 % Supplementary ingredients: Lactase (Derived from yeast) 0,15 mg 0.1 % HPMC (Hydroxypropyl Methylcellulose) acid-resistant capsule 47 mg 31.8 % Microcrystalline cellulose (Derived from pulp) 98,4 mg 66.5 % Dosage for adults: 2 - 10 capsules daily (stronger version 9 capsules daily) Route of administration: oral Contraindication: allergy to dairy product components Precaution: pregnancy and lactation Storage: Can be stored in at + 5 to +25°C, on dry place for up to two years Manufacturer: Saisei Pharma, Osaka, MORIGUCHI city, OKUBO-cho, 3-34-8. Japan
15751711|NCT04845945|Biological|PCV13|Blood draw after the vaccination
15751712|NCT04845919|Drug|5-Aminolevulinic Acid|"SDT treatment with 5-ALA using the ExAblate Model 4000 Type-2 Neuro-System."
15751713|NCT04845906|Device|StatLock™ Catheter Stabilization Device and the StatLock™ stabilization device accessory (Foam Strip)|Each participant will have 2 separate devices applied, one to each arm, with or without a Foam Strip.The participant will also wear a dressing over top of a StatLock™ compatible catheter, which will be connected to an extension set. For this study, the catheter will not be inserted into the study participant but instead will be shortened or modified and placed on the skin and secured with the StatLock™ Stabilization Device. The use of the catheters, extension set, and the dressing represents how the device would be used in a clinical setting.
15751714|NCT04845893|Other|Treatment of Ewings Sarcoma of bone according clinical practice (includes drugs, surgery, radiotherapy or any other received treatments)|This observational study collects all the treatments received by the patients according clinical practices or experimental trials and therefore includes drug/biological/surgical/ radiotherapy and any other applicable treatments
15751715|NCT04845880|Diagnostic Test|Spike protein (S) or the nucleocapsid (N) of SARS-CoV-2|Blood level of spike protein (S) or the nucleocapsid (N) of SARS-CoV-2
15751716|NCT04845867|Device|ISAR-M THYRO|A diagnostic device for early detection of haemorrhage following thyroid surgery
15751717|NCT04845841|Drug|Elinzanetant (BAY3427080) treatment A|Single oral dose
15751718|NCT04845841|Drug|Elinzanetant (BAY3427080) treatment B|Single oral dose
15751719|NCT04845828|Procedure|Sentinel lymph node mapping|"Laparoscope or robotic hysterectomy with/without bilateral salpingo-oophorectomy
~Inject 1.25 mg/ml of ICG and a total of 6ml into the cornual area (0.5-1 cm deep) of the uterus. And then inject 1 ml of mucous membrane (1-3 mm deep) and 1 ml of substrate (1-2 cm deep) into the cervix, and a total of 4 ml in each direction of 3 and 9 o'clock.
~If metastasis is confirmed to the sentinel lymph node in the frozen biopsies, the lymph node detection is performed, and if there is no meta, the lymph node detection is not performed."
15751720|NCT04845828|Procedure|Routine lymph node dissection|"Laparoscope or robotic hysterectomy with/without bilateral salpingo-oophorectomy
~Inject 1.25 mg/ml of ICG and a total of 6ml into the cornual area (0.5-1 cm deep) of the uterus. And then inject 1 ml of mucous membrane (1-3 mm deep) and 1 ml of substrate (1-2 cm deep) into the cervix, and a total of 4 ml in each direction of 3 and 9 o'clock.
~Regardless of the frozen biopsies result, the lymph node detection is performed."
15751721|NCT04845802|Other|Inspiratory muscle training(high-IMT group)|A mechanical pressure threshold loading device (POWERbreathe, POWERbreathe International Ltd, UK) will be used for the training. Training intensity will set at 60% of the maximum inspiratory pressure.
15751722|NCT04845802|Other|Inspiratory muscle training(low-IMT group)|Dancers will be perform at a load setting of level 1 (corresponding to ~10% baseline MIP), using the same device as the training group.
15751723|NCT04845789|Other|Non-interventional|Non-interventional. Interview would be conducted for data collection.
15751724|NCT04845776|Dietary Supplement|ANRC Essentials Plus|a vitamin/mineral supplement designed for children and adults with autism
15751750|NCT04845568|Behavioral|Virtual Reality Experience|"The virtual reality experience includes psychoeducation content about healthy eating and consideration of future consequences. It includes a game where participants are in a go kart and pick up healthy or unhealthy foods on the road. Participants play in the present and in the future."
15751725|NCT04845763|Other|FQoR-15 questionnaire|The FQoR-15 questionnaire (French version) consists of 15 questions concerning five domains (the patient's feelings, comfort, pain, dependence on the health care team and psychological well-being). Two to three minutes are required to complete all the questions. If the patient is not able to read the questionnaire himself, a third person can ask the patient the questions orally. In the case of ambulatory surgery, the patient is contacted by telephone to answer the questionnaire. Each item is scored from 0 to 10 and the total score is the sum of the score obtained for each item, i.e. a score from 0 to 150.
15751726|NCT04845750|Device|Rodeo Micro Mapping Catheter|The Rodeo Micro Mapping Catheter is used during cryoablation of atrial fibrillation patients for determination of pulmonary vein isolation
15751727|NCT04845737|Other|sympathetic skin response measurement|"Sympathetic skin response(SSR) was studied with upper and lower extremity hand and foot recording of all participants, and amplitude and latency values will be recorded. SSR measurement will be made at room temperature of 25 ºC, while the patients are resting in the supine position. 6 mm silver disc electrodes will be used as the recording electrode.
~The relationship between the patients' vitamin D levels and inflammatory response markers and their sympathetic skin responses will be investigated by statistical analysis."
15751728|NCT04845724|Other|Standard Diet|
15751729|NCT04845724|Other|Modified Diet|
15751730|NCT04845711|Other|Control group|patients will receive general anesthesia only.
15751731|NCT04845711|Procedure|Erector spinae plane block group|patients will receive general anesthesia and bilateral ultrasound guided erector spinae plane block (20ml Bupivacaine 0.25%)
15751732|NCT04845711|Procedure|Quadratus lumborum block group|patients will receive general anesthesia and bilateral ultrasound guided quadratus lumborum block (20 ml Bupivacaine 0.25%)
15751733|NCT04845698|Device|i-Dashboard|i-Dashboard is a team-designed, patient-centered electronic medical record viewer, which retrieves data from multiple databases and provides a quick representation of essential metrics for each patient.
15751735|NCT04845672|Other|2% chlorhexidine gluconate|Children in 2% chlorhexidine gluconate group , which is the routine practice of the hospital, and a wiping bath in accordance with the bath protocol specified. The bath procedure will take 10-15 minutes. Before wiping bath swab sample will provide from armpit and groin with circular manner and 6 hours later swap sample will be provided from the same areas again. The swab sample taken will be planted on blood agar medium and kept at + 4-8 ℃ for an average of 18-24 hours. After it is planted on blood agar medium, it will be kept at + 4-8 ℃ for an average of 18-24 hours . A total of 12 swab samples will be taken for 3 days from each child and from the same areas, body flora will be evaluated.
15751736|NCT04845672|Other|soap-free body cleaning solution|Children in a wiping bath with soap-free body washing solution group, and a wiping bath in accordance with the bath protocol specified. The bath procedure will take 10-15 minutes. Before wiping bath swab sample will provide from armpit and groin with circular manner and 6 hours later swap sample will be provided from the same areas again. The swab sample taken will be planted on blood agar medium and kept at + 4-8 ℃ for an average of 18-24 hours. After it is planted on blood agar medium, it will be kept at + 4-8 ℃ for an average of 18-24 hours . A total of 12 swab samples will be taken for 3 days from each child and from the same areas, body flora will be evaluated.
15751737|NCT04845659|Drug|Doptelet Pill|40 mg or 60 mg Doptelet orally 10-13 days before planned procedure.
15751738|NCT04845646|Drug|ASC41|5mg/tablet
15751739|NCT04845646|Drug|Itraconazole|200mg/capsule
15751740|NCT04845646|Drug|Phenytoin|300mg/capsule
15751741|NCT04845633|Other|Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Healthy Children|Healthy children will be given conventional toothbrush.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces
15751742|NCT04845633|Other|Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Healthy Children|Healthy children will be given toothbrush with Customized Handle.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces
15751743|NCT04845633|Other|Evaluation of the Effectiveness of Conventional Toothbrush in Dental Plaque Control in Children with Down Syndrome|Children with Down syndrome will be given conventional toothbrush.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 week by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces
15751744|NCT04845633|Other|Evaluation of the Effectiveness of Customized Handle Toothbrush in Dental Plaque Control in Children with Down Syndrome|Children with Down syndrome will be given toothbrush with Customized Handle.Plaque scores in groups will be assess pre-brushing and post-brushing in baseline, a week, and after 3 weeks by using the Turesky Modification of the Quigley-Hein Plaque Index (TMQHPI) for both buccal and lingual surfaces
15751745|NCT04845620|Drug|ARQ-151 Active|ARQ-151 Cream 0.05% - Active
15751746|NCT04845620|Drug|ARQ-151 Vehicle|ARQ-151 Cream - Vehicle
15751747|NCT04845607|Drug|Amiodarone Injection|Amiodarone continuous infusion during 24 hours from return of spontaneous circulation.
15751748|NCT04845594|Behavioral|MySmileBuddy (MSB)|The technology-based MSB program equips community health workers (CHWs) with an iPad-based app that facilitates assessment of a child's early childhood caries (ECC).
15751749|NCT04845581|Procedure|Diagnostic tests: Determination of the gingival phenotype, measure gingival thickness and width of keratinized tissue|Gingival thickness was measured using UGTM method and CBCT/ CAD with PDIP technology at upper incisors and canines in three points localized midbucally : Free gingival thickness (FGT), supracrestal ( SGT) and crestal (CGT). Width of keratinized tissue was measured using periodontal probe calibrated for 1 mm. The gingival phenotype was determined by both methods according to the following criteria: GT ≤ 0,7 mm - thin gingival phenotype, GT &gt; 0,7 mm ≤ 1,0 mm - medium gingival phenotype, GT &gt; 1,0 mm - thick gingival phenotype. Toincrease the repeatability of the results, two researchers tested the same values twice on 2days interval between sessions.
15751798|NCT04845061|Drug|Nebivolol Tablets|cardio selective beta-1 blocker
15751799|NCT04845048|Biological|Adsorbed COVID-19 (Inactivated) Vaccine|Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac/Butantan Institute
15751751|NCT04845555|Other|Observation of the association between clotting factor level and risk of bleeding whilst physical activity|"The participants of this study will be monitored for a period of twelve months regarding individual clotting factor level, bleeding episodes as well as type and intensity of physical activity. By doing so, bleeding events, factor consumption as well as the course of the individual factor clotting factor level will be documented via the mobile application myPKFiT. This individual factor treatment regime will be compared with the retrospective treatment outcome in the last twelve months before the first study visit."
15751752|NCT04845542|Behavioral|ReStoreD|ReStoreD is a remotely-administered behavioral intervention in which couples coping with stroke learn and practice goal-setting, communication strategies, and positive psychology activities, such as expressing gratitude, finding meaning, and fostering connections. Participants are provided with 8 weekly modules, each featuring two components: 1) psychoeducational materials, such as an informational video and resources/links about a general topic related to resilience, coping, and/or overall well-being of the individual and couple, and 2) examples of positive psychology activities that relate to the week's theme or topic. Participants are asked to complete at least two positive psychology activities alone and two together each week.
15751753|NCT04845529|Device|transcranial direct current stimulation (tDCS)|We will apply tDCS to the patients' brains for 20 minutes at the intensity of 1.5mA. Each patient will undergo the three sessions (separated by at least 24h to minimize carry-over effects), in a pseudo-randomized order across patients.
15751754|NCT04845516|Other|Efficacy of apheresis|Efficacy of apheresis
15751755|NCT04845503|Radiation|MR-guided Radiotherapy|Total Dose 37,5 Gy, Single Dose 7,5 Gy, 5 Fractions applied in 1-2 weeks
15751756|NCT04845490|Drug|Mitomycin|Mitomycin is used as drug for hyperthermic intraperitoneal chemotherapy. Choice of perfusate: Normal saline. Drug selection and dose: Mitomycin 30mg/m2. Treatment course: 2 times (the first time is after surgery, the second time is 48h after first time).
15751757|NCT04845490|Drug|Lobaplatin|Lobaplatin is used as drug for hyperthermic intraperitoneal chemotherapy. Choice of perfusate: Normal saline. Drug selection and dose: Lobaplatin 50mg/m2. Treatment course: 2 times (the first time is after surgery, the second time is 48h after first time).
15751758|NCT04845477|Device|Magnetic tape|magnetic tape is applied without creating any tension over the cutaneous nerves of the groin with less internal hip rotation
15751759|NCT04845477|Device|Kinesiology tape|kinesiology tape is applied without creating any tension over the cutaneous nerves of the groin with less internal hip rotation
15751760|NCT04845464|Other|Cognitive Assessment (not diagnostic)|Sleep quality and cognition will be assessed in young adults
15751761|NCT04845451|Other|Minimal surgical exploration for a neuroma|Orientation marking of the trigger point by injectable sterile methylene blue dye 0.1ml. Marking a 3-centimeter long incision line 7 mm from the Neuroma marking on the skin. Local anesthesia using plain 2% lidocaine infiltration of the circumferential exploratory area. Sterile prep and drape in surgical fashion. Meticulous exploratory preparation of the subcutaneous tissue 20 mm at each side of the incision line. Appropriate visibility of the ZT nerve branches embedded in lipomatous and connective tissue over the temporal fascia. Exploratory visualization of the subcutaneous marked tissue by methylene blue using a binocular magnification eases visualization. Using an Adson tissue forceps with side grasping teeth, now an exploratory touch of the above and distal of the marking would deliver the hypersensitive painful Neuroma tissue for sharp excision using surgical scissors. Control of bleeding and skin closure. Sterile pressure dressing. Specimen be sent to pathologic examination.
15751762|NCT04845438|Diagnostic Test|fibrogastroscopy, biopsy of the gastric mucosa, microscopy biopsy materials, using Bile Reflux Index|fibrogastroscopy, biopsy of the gastric mucosa, microscopy biopsy materials, using Bile Reflux Index
15751763|NCT04845412|Diagnostic Test|Hearing screening tests|"Our study was conducted in accordance with the National Hearing Screening Test Protocol. The newborns had transient evoked otoacoustic emissions (TEOAE) with click stimulus as a hearing screening test in the first three days after birth, using Otometrics Madsen Accuscreen S/N: 36484 (USA) device."
15751764|NCT04845399|Drug|Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection|Participants received prophylaxis treatment at 50 IU/ kg every three days.30-50 IU/kg is recommended to administration while bleeding occurs during the experiment.
15751765|NCT04845386|Device|TOF Cuff on arm|The TOF Cuff will be installed on one arm in opposite of TOF Scan. After intubation dose of mivacurium continuous monitoring of neuromuscular block started until complete recovery of neuromuscular block.
15751766|NCT04845386|Device|TOF Cuff on lower leg|The TOF Cuff will be installed on one lower leg. After intubation dose of mivacurium continuous monitoring of neuromuscular block started until complete recovery of neuromuscular block.
15751767|NCT04845386|Device|TOF Scan on toe|The TOF Scan will be installed on hallux . After intubation dose of mivacurium continuous monitoring of neuromuscular block started until complete recovery of neuromuscular block.
15751768|NCT04845386|Device|TOF Scan on adductor pollicis|The TOF Scan will be installed on Thumb. After intubation dose of mivacurium continuous monitoring of neuromuscular block started until complete recovery of neuromuscular block.
15751769|NCT04845386|Device|TOF Scan on corrugator supercilii|The TOF Scan will be installed on corrugator supercilii. After intubation dose of mivacurium continuous monitoring of neuromuscular block started until complete recovery of neuromuscular block.
15751770|NCT04845373|Other|Mediterranean diet|Diet intervention:Mediterranean diet
15751771|NCT04845373|Other|Control diet: Low fat diet|Low fat diet
15751772|NCT04845360|Device|pressure transducer (PSL-200GL, Kyowa Electronic Instrument Co. Ltd., Japan)|The device was fixed on the patient's skin with Scotch™ tape, along with an adjustable belt with a small button to give suitable pressure on the transducer.
15751773|NCT04845347|Device|Bright Light Therapy|Participants will be provided with active, unaltered Re-Timer glasses that will be worn in the morning daily for 60 minutes for 5 weeks on study.
15751774|NCT04845347|Device|Dim Light Therapy|Participants on this arm will wear the placebo version of the Re-Timer fitted with neutral density filters. These will be worn in the morning daily for 60 minutes for 5 weeks on study.
15751800|NCT04845035|Drug|Dasatinib|By mouth
15751801|NCT04845035|Drug|Ponatinib|By mouth
15751802|NCT04845035|Drug|Berlin-Frankfurt-Münster Chemotherapy|with varied cycles, including Daunorubicin, Vincristine, Prednisone, Pegaspargase, Rituximab, Cytarabine, Mercaptopurine, Cyclophosphamide, Methotrexate, Doxorubicin, Thioguanine, and Dexamethasone
15751775|NCT04845334|Behavioral|RR intervention|"The short psychological intervention consists of a narrative interview and a psychocorporeal intervention. Narrative interview: this is an interview aimed at exploring the experience and awareness of illness. The sharing of the dimension of pain and suffering, the verbalization of emotions, the narration of the history of illness, expectations and fears related to the intervention will be aimed at an emotional and cognitive restructuring of the experience of illness, improving the perception of internal resources and resilience.
~Psycho-corporeal intervention:it is a training to the psychophysiological technique of the Relaxation Response (R.R.) of Hebert Benson (Mind-Body Medical Institute of Havard), aimed at stress management and consequently at reducing the perception of pain"
15751776|NCT04845321|Drug|VNRX-9945|Part 1: One dose except food effect cohort (receives two doses) Part 2: 14 doses (once a day for 14 days)
15751777|NCT04845321|Drug|Placebo for VNRX-9945|Part 1: One dose except food effect cohort (receives two doses) Part 2: 14 doses (once a day for 14 days)
15751778|NCT04845295|Other|resistance training|Both experimental groups performed two exercises to target elbow flexor and knee extensor muscles: biceps curl on a Scott bench and parallel barbell squat, respectively. All sessions were performed at the same time (13-15 h), with a minimum 48 h rest between sessions on the same days during the week. For both groups, the intensity of load (1RM%) and number of sets were as follows: in the first three weeks the subjects exercises with ̴ 60% of 1RM in 3 sets, while during the next four weeks the load was set at ̴ 70% of 1RM in 4 sets. All repetitions were performed until muscular failure. The pause between sets was 2 minutes.
15751779|NCT04845282|Dietary Supplement|Graded Protein plus Resistance Training|"Participants will be counseled to consume the specific level of dietary protein plus the protein supplement is MusclePharm Combat 100% Whey. Specific values per week are listed below:
~Week 1: 25 g of protein supplement (0.8 g protein/kg body weight) Week 2: 25 g of protein supplement (1.0 g protein/kg body weight) Week 3: 50 g of protein supplement (1.2 g protein/kg body weight) Week 4: 50 g of protein supplement (1.4 g protein/kg body weight) Week 5: 50 g of protein supplement (1.4 g protein/kg body weight) Week 6: 75 g of protein supplement (1.6 g protein/kg body weight) Week 7: 75 g of protein supplement (1.8 g protein/kg body weight) Week 8: 75 g of protein supplement (2.0 g protein/kg body weight) Week 9: 75 g of protein supplement (2.2 g protein/kg body weight) Week 10: 100 g of protein supplement (2.2 g protein/kg body weight)"
15751780|NCT04845282|Dietary Supplement|RDA Protein plus Resistance Training|Participants will be counseled to consume the RDA level of protein (0.8g/kg/day) utilizing only dietary protein.
15751781|NCT04845256|Device|SOMAVAC 100 Sustained Vacuum System|Evaluate performance of sustained vacuum system compared to manual suction bulbs
15751782|NCT04845243|Behavioral|Emotionen Verstehen und Ausdrücken (E.V.A.)|The online training is focused on the strengthening of socioemotional competences and consists of different training tasks (up to 3 million) presented to the participant as mini games. These training tasks are specifically designed according to empirical findings to match the socio-emotional recognition needs of people with ASD. During these games, an adapted Elo-Algorithm allows to automatically evaluate the participants' performance and adapts the difficulty levels throughout the users' progress in the training.
15751783|NCT04845230|Behavioral|FreshRx Nourishing Healthy Starts|This is a field experiment study that incorporates referrals to public programs, food supplementation and nutrition education, or integrative care services provided by a Licensed Masters Social Worker.
15751784|NCT04845217|Drug|Peppermint oil|Enteric coated peppermint oil taken by mouth three times daily for 8 weeks.
15751785|NCT04845217|Drug|Coconut Oil|Enteric coated coconut oil taken by mouth three times daily for 8 weeks
15751786|NCT04845204|Other|Relaxation Treatment|Relaxation Group recieve progressive muscle relaxation exercises additional to the standard exercises. The relaxation exercises are applied two times a day till the discharge day starting on the postoperative day one. Progressive muscle relaxation included the relaxing of different muscle groups along with deep breathing. The maximal contraction period consist of the contraction of muscle groups around ankle, calf, knee, hip, lumbar, thoracic and cervical regions, shoulder, arm, forearm for 5 s and continued with a relaxation period for 30 s while focusing on breathing. These two periods ware repeated for each muscle groups and lasted approximately 30 min
15751787|NCT04845204|Other|Standard Exercises|The physiotherapy protocol is applied under the supervision of the same physiotherapist within a progressive manner immediately after surgery. Continued passive range of motion is applied twice a day starting with 45º of knee flexion range of motion and increased gradually as tolerated. All patients performed same isometric, isotonic and active exercises. Patients were instructed to bear weight as tolerated on the postoperative day 1
15751788|NCT04845191|Biological|hAd5-S-Fusion+N-ETSD vaccine|hAd5-S-Fusion+N-ETSD is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen S fusion protein and N with an enhanced T-cell stimulation domain.
15751789|NCT04845178|Drug|ABP-450|ABP-450 (prabotulinumtoxinA) contains a 900 kDa botulinum toxin type-A complex produced by the bacterium Clostridium botulinum.
15751790|NCT04845178|Drug|Placebo|0.9% sodium chloride, sterile, unpreserved, USP/PhEur
15751791|NCT04845165|Other|Biopsy|Biopsy of subcutaneous adipose tissue
15751792|NCT04845139|Drug|Nivolumab|Nivolumab given intrathecally
15751793|NCT04845100|Other|Animal Assisted Activity Program|"Animal Assisted Activity Program (HayDAP)
~st week (Pre-test, introduction-introduction)
~nd week (Information about cats)
~th (Cat story reading)
~th week (Teaching songs, poems, rhymes about cat)
~th week (Making / decorating a cat house)
~th week (Participation in the rehabilitation program with the treatment animal)
~th week (Evaluation and closing, last test)"
15751794|NCT04845087|Other|Ozonized water|Irrigation of dental implants with ozonized water
15751795|NCT04845087|Other|Placebo|Irrigation of dental implants with water
15751796|NCT04845074|Procedure|TSA-group|Anatomical total shoulder arthroplasty followed by standard rehabilitation.
15751797|NCT04845074|Other|Exercise-group|The exercise-group will attend a 12-week exercise program with one weekly physiotherapist-supervised session supplemented with two weekly sessions of home-based exercises. Utilisation of a predefined training protocol describing procedures and content of each session secure uniformity and standardisation of the intervention. The exercise program consists of two warm-up exercises and five exercises that target shoulder range of motion and muscle strength. Furthermore, a link to a video, informing about glenohumeral osteoarthritis, the role of exercise and exercise related pain, will be sent to all patients in the exercise-group. The physiotherapists delivering the exercise intervention are not otherwise related to the trial.
15751806|NCT04844996|Procedure|Surgical induction of endometriotic explants|"Surgical induction of endometriosis was done as: A 5-cm vertical midline incision was made and a distal segment 1 cm in length of the right uterine horn was resected. The segment was split longitudinally, and a 5 X 5 mm piece was sectioned.
~This piece of uterine tissue was transplanted without removing the myometrium onto the inner surface of the right abdominal wall with the serosal surface apposed and secured with single nonabsorbable 5-0 polypropylene suture at the middle to the abdominal wall. The abdominal incision was closed in two layers
~Drug administration:
~Vehicle treatment (1 mL/kg/day saline) was administered orally to the control group with the gavage methodology. Ezetimibe (1 mg/kg/day (Ezetrol®, Merck Sharp Dohme, Istanbul, Turkey) was administered orally with gavage methodology to the rats in the study for 28 days postoperatively"
15751809|NCT04844970|Drug|Anamorelin Hydrochloride|Anamorelin HCl is an orally-active selective ghrelin receptor agonist which has shown anabolic and appetite-stimulating effects.
15751810|NCT04844970|Drug|Placebo|Anamorelin placebo
15751811|NCT04844957|Drug|Vitamin D|Clinical Study
15751812|NCT04844957|Device|Full automatic chemiluminescence measuring instrument|Chemiluminescence immunoassay
15751813|NCT04844931|Procedure|RIC + PostC + Standard PCI|RIC by arm ischemia initiated on hospital admission plus local PostC by re-inflating the angioplasty balloon after re-opening the infarct-related artery
15751814|NCT04844931|Procedure|Standard PCI|Standard PCI
15751815|NCT04844918|Drug|Tirzepatide|Administered SC
15751816|NCT04844918|Other|Placebo|Administered SC
15751817|NCT04844905|Drug|Ivermectin|Ivermectin will be given as tablets of 3 or 6mg. It will be given at 300-400μg/kg/day for 3 days (to the nearest whole tablet) each month for 3 months. It will be taken on an empty stomach with water.
15751818|NCT04844905|Drug|Placebo|Placebo will be given as tablets of 3 or 6mg (identical to Ivermectin in colour, size, shape and packaging). It will be given at 300-400μg/kg/day for 3 days (to the nearest whole tablet) each month for 3 months. It will be taken by mouth with water and without food.
15751819|NCT04844905|Drug|Dihydroartemisinin-piperaquine|Dihydroartemisinin-piperaquine will be given as tablets of 320/40mg (adult) and 160/20mg (child) piperaquine/dihydroartemisinin per tablet. Administration of a full course of dihydroartemisinin-piperaquine will be given in accordance with the manufacturer's guidelines once daily for 3 days each month for 3 months according to body weight. Dihydroartemisinin-piperaquine will be taken by mouth with water and without food.
15751820|NCT04844892|Device|Lungpacer PROTECT Diaphragm Pacing Therapy|PROTECT diaphragm pacing therapy is intended to stimulate the diaphragm to preserve and improve inspiratory muscle strength in mechanically ventilated patients.
15751821|NCT04844879|Device|NextAR TKA system|The NextAR TKA system is a surgical guidance system which measures intra-operatively the effect of prosthesis alignment and positioning on soft tissue balance.
15751822|NCT04844866|Genetic|MB-CART2019.1|MB-CART2019.1 is designed to effectively target malignant B cells in patients suffering from late stage haematological B-cell malignancies. MB-CART2019.1 consists of autologous cluster of differentiation CD20/CD19 chimeric antigen receptor (CAR) transduced CD4/CD8 enriched T cells, derived from a leukapheresis and processed by using the CliniMACS Prodigy® device.
15751823|NCT04844866|Drug|R-GemOx or BR plus polatuzumab vedotin|Immunochemotherapy will be administered as per arm description.
15751824|NCT04844853|Device|electroencephalography|128-channel electroencephalography
15751825|NCT04844853|Device|Tactile stimulation|Vibrotactile sequence on the forearm
15751826|NCT04844853|Behavioral|Attention Network task (computerized)|Computer-based game challenging orienting and executive attention. The subject must chose which side an animal is going, using left and right buttons, depending on the validity of a cue and the congruency of flankers.
15751827|NCT04844853|Behavioral|Head-toes-knees-schoulders|Following motor commands such as touch your head when they are congruent or incongruent.
15751828|NCT04844853|Behavioral|Laby 5-12|Test of motor planning using labyrinths
15751829|NCT04844853|Behavioral|M-ABC 2|Test of motor functions using various subtests of gross and fine motor function.
15751830|NCT04844853|Behavioral|Stroop animals|Stroop test for preK children using animals instead of words
15751833|NCT04844827|Genetic|Conserving routinely performed pleural biopsies in our biological resources center to realize multiomics and bioinformatics analyzes secondarily|Interventions will consist of a diagnostic and symptomatic videothoracoscopy in patients with pleural metastasis under general anesthesia, as part of a standard of care procedure. Fragments of these pleural biopsies (one for routine diagnosis and two for scientific purposes) will enrich the biocollection. Five blood samples will be taken at the time of surgery (3 to 5 ml / tube). These biological samples will be stored in the HCL CRB tumor bank. At the same time, patient demographic data will be collected and anonymized. In the long term, the biological material will be used by IARC for carrying out multi-omics and bioinformatics analyzes
15751834|NCT04844814|Drug|Anakinra 100Mg/0.67Ml Inj Syringe|Anakinra 100 mg/d subcutaneous injection
15751835|NCT04844814|Drug|Prednisone|Prednisone 30 mg/d
15751836|NCT04844814|Drug|Placebo of Prednisone|Placebo of Prednisone
15751837|NCT04844814|Drug|Placebo of Anakinra|Placebo of Anakinra
15751838|NCT04844801|Procedure|Risk control strategy|"Magnesium sulfate 2g intravenous bolus over 20 mn (if creatinine clearance >30 mL/min)
~Control of the modifiable NOSVA risk factors: hypovolemia, sepsis, metabolic disorders (e.g., hypokalemia, hyponatremia), acidosis, hypoxia, excess cardiac inotropism of vasopressors, central venous catheter malposition, hyperthermia."
15751839|NCT04844801|Procedure|Rate control strategy:|"Risk-control as described above
~Low dose amiodarone:
~Intravenous bolus (day-1): 4 mg/kg over 1hr
~Enteral dose maintenance (day-1 to day-7): 200mg once a day (150 mg intravenous over 1hr if enteral route is unavailable)"
15751916|NCT04844060|Other|Lumbar punction|Lumbar punction
15751917|NCT04844047|Other|Exercise|refer to arm descriptors
15751918|NCT04844047|Other|Exercise|refer to arm descriptors
15753048|NCT04834336|Other|Physical training|Physical training will be performed with exercise including balance, mobility, functional strength, and endurance.
15751840|NCT04844801|Procedure|Rhythm control strategy:|"Risk control as described above
~High dose amiodarone:
~Intravenous bolus (day-1): 7 mg/kg over 1hr; followed by continuous intravenous maintenance: 1200 mg over the first 24 hrs (infusion pump)
~Enteral dose maintenance Day-2 and day-3: 400 mg three times a day (720 mg continuous intravenous over 24 hrs if enteral route is unavailable).
~Day-4 to day-7: 200 mg once a day (150 mg intravenous over 1hr if enteral route is unavailable)
~- Electrical cardioversion if:
~NOSVA persists after initial bolus of amiodarone AND norepinephrine base (or epinephrine base) doses > 0.3 µg/kg/min;
~NOSVA persists more than 6 hrs after initial amiodarone bolus."
15751841|NCT04844775|Biological|Drep-HIV-PT1 0.2mg and CN54gp140/MPLA-L|"Drep-HIV-PT1 The DREP-HIV-PT1 is a vaccine designed to elicit an immune response against human immunodeficiency virus-1 (HIV-1) and prevent infection by HIV-1 and/or disease caused by HIV-1. It is an alphavirus-based DNA replicon in which the sequences coding for the viral capsid and envelope have been replaced by the sequences encoding HIV-1 gp140 (96ZM651) antigen.
~CN54gp140+MPLA-L. Recombinant CN54gp140 is a HIV-1 envelope protein from the clade C strain 97/CN/54 isolate, which comprises a sequence of 634 amino acids. MPLA is a non-toxic version of LipoPolySaccharide (LPS), which is isolated from the LPS lipid A region of Salmonella Minnesota R595 and retains the immune-stimulatory properties of LPS, but exhibits low toxicity."
15751842|NCT04844775|Biological|DREP-HIV-PT1 1mg and CN54gp140/MPLA-L (see above)|"Drep-HIV-PT1 1mg (see above)
~Drep-HIV-PT1 1mg (see above)"
15751843|NCT04844775|Biological|DNA-HIV-PT123 4mg and CN54gp140/MPLA-L|"DNA-HIV-PT123 HIV vaccine includes three DNA plasmids that encode clade C ZM96 Gag, clade C ZM96 Env, and CN54 Pol-Nef
~CN54gp140/MPLA-L Recombinant CN54gp140 is a HIV-1 envelope protein from the clade C strain 97/CN/54 isolate, which comprises a sequence of 634 amino acids. MPLA is a non-toxic version of LipoPolySaccharide (LPS), which is isolated from the LPS lipid A region of Salmonella Minnesota R595 and retains the immune-stimulatory properties of LPS, but exhibits low toxicity."
15751844|NCT04844762|Behavioral|Menthol cigarettes substitutes|In Phase 1, participants will complete 4 smoking sessions using a different product each session to examine each product's abuse liability.
15751845|NCT04844762|Behavioral|Usual brand menthol cigarettes and substitutes|In Phase 2, to assess uptake, changes in subjective effects, and use over time, participants will select their preferred study product from Phase 1 and be instructed to completely substitute the product for their usual brand menthol cigarette for one week.
15751846|NCT04844762|Behavioral|Menthol cigarettes substitutes and menthol cigarettes|In Phase 3, participants will complete a final in-lab visit to assess the substitutability of their preferred product from Phases 1 and 2, under simulated ban conditions using a progressive ratio task.
15751849|NCT04844736|Procedure|CT Simulation|"Patient will undergo routine CT simulation to initiate radiation treatment planning process. For the purposes of this study, the day of CT simulation mapping scan will be counted as day 0. After the patient completes the CT simulation scan, the CT images and plan/structure files will be sent to the treatment planning system. The treating physician will contour the gross tumor volume (GTV) including the involved primary lung tumor and/or the involved lymph nodes."
15751850|NCT04844710|Combination Product|acupuncture and standard care|manual acupuncture in acupoint LI4, LI11, ST36 every 2 days for 6 times standard care
15751851|NCT04844710|Drug|standard care|standard care only
15751852|NCT04844684|Other|Blood and urine collection|Blood sampling urine collections before RYGP and 1 month and 1 year after.
15751853|NCT04844671|Device|da Vinci Surgical Systems|The da Vinci Surgical Systems enable surgeons to perform delicate and complex operations through a few small incisions with robotic assisted surgery.
15751854|NCT04844658|Drug|NASAFYTOL®|"Dietary supplement presented as green soft gel capsules of 1008 mg, containing
~A highly bioavailable mixture of turmeric extract or curcumin (hydrophobic polyphenol of rhizomes of Curcuma longa L.),
~And natural quercetin from Sophora japonica L. (pagoda tree or Chinese scholar tree) and vitamin D3 (at 60 % of the nutrient reference values).
~NASAFYTOL® is an innovative formulation based on Polysorbate 80 (Tween 80R) designed to increase the bioavailability of the active components in humans. To improve the stability of the active ingredients in the capsule, the presence of a weak acid (citric acid) is essential.."
15751855|NCT04844658|Drug|FULTIUM® -D3 800|Vitamin D , FULTIUM® - D3 800 is a blue soft capsule that contains 800 UI (20 µg) of D3 vitamin (cholecalciferol).
15751856|NCT04844645|Other|mini program|To design, construct, and test the mini program in patients managing cancer pain
15751857|NCT04844645|Other|conventional pharmaceutical care|conventional pharmaceutical care
15751858|NCT04844632|Biological|Vaccine anti-Covid19|Vaccination with AstraZeneca or Pfizer-Biontech anti-Covid19 vaccine
15751859|NCT04844619|Drug|4mg/ml KDR2-2 suspension eyedrop|"KDR2-2 is a synthetic anti-angiogenic chemical compound with highly effective inhibition on vascular endothelial growth factor receptor-2 (VEGFR2), and an additional, moderate inhibitory effect on platelet-derived growth factor receptor β (PDGFRβ).
~KDR2-2 suspension eyedrop is developed for the treatment of iris neovascularization."
15751860|NCT04844619|Drug|16mg/ml KDR2-2 suspension eyedrop|"KDR2-2 is a synthetic anti-angiogenic chemical compound with highly effective inhibition on vascular endothelial growth factor receptor-2 (VEGFR2), and an additional, moderate inhibitory effect on platelet-derived growth factor receptor β (PDGFRβ).
~KDR2-2 suspension eyedrop is developed for the treatment of iris neovascularization."
15751862|NCT04844580|Drug|Inhaled Aviptadil|Aviptadil is the synthetic analogue of the Vasoactive Intestinal Peptide (VIP), a biologically active 28 amino acid natural peptide that is endogenously synthesized in humans. It is one of the signaling molecules of the neuroendocrine immune network and has vasodilator, anti-proliferative, anti-inflammatory and immunomodulatory properties.
15751863|NCT04844580|Drug|Placebo|Aviptadil Placebo will be used for this arm.
15751919|NCT04844034|Dietary Supplement|High-EPA multinutrient supplement.|"Three capsules with the largest meal of the day providing:
~1,125 mg EPA
~441 mg DHA
~330 mg Magnesium
~7.5 mg a-tocopherol"
15751864|NCT04844567|Device|COVVR|Participants wear a respiration belt (Vernier, Go Direct) that continuously transmits thoracic circumference readings to a mobile phone (Samsung Galaxy S8) in real-time. The mobile device is placed in a headset (Zeiss VR ONEPLUS) and used to create a stereoscopic, immersive scene in Virtual Reality. The data from the respiration belt is used to map the on-going respiration pattern onto a virtual body in the scene in one of two feedback conditions: 1) synchronous: participants receive real-time feedback of their respiration, 2) asynchronous: participants receive asynchronous, frequency modulated feedback of their respiration.
15751865|NCT04844554|Other|HD-tDCS 4mA|This group will receive HD-tDCS 4mA intensitie. The intervention will be applied in 20 daily sessions at ICU and 10 daily sessions at Hospital simultaneously to physical rehabilitation. The HD- tDCS will be started with a 30 s ramp-up to the desired intensity, which was maintained for 20 min.
15751866|NCT04844554|Other|HD-tDCS 2mA|This group will receive HD-tDCS 2mA intensitie. The intervention will be applied in 20 daily sessions at ICU and 10 daily sessions at Hospital simultaneously to physical rehabilitation. The HD- tDCS will be started with a 30 s ramp-up to the desired intensity, which was maintained for 20 min.
15751867|NCT04844528|Drug|Nicotinamide|oral nicotinamide 500 mg twice daily (BID)
15751868|NCT04844528|Drug|Placebo|oral placebo twice daily for first year. Cross over to oral nicotinamide 500 mg twice daily (BID) for year two.
15751869|NCT04844502|Other|Physical rehabilitation|Rehabilitation can be applied to the intervention group in two ways: in person or by home orientation. The face-to-face form will correspond to 5 weeks of intervention, 3 sessions per week, which should include: a) aerobic resistance training of 30 minutes in total, five minutes of cooling down); b) strengthening of peripheral muscles using 20-minute sessions of calisthenic exercises; and c) maintained active stretching, for 10 minutes, for the main muscle groups. The home-based intervention will correspond to three months of daily activities, monitored twice a week in the first month and once a week in the second and third months, by telephone or video conference, and will follow an exercise protocol that includes: a) aerobic resistance training for 15 uninterrupted minutes; b) anaerobic training to strengthen the peripheral muscles for 15 minutes at intervals with breathing exercises; and c) maintained active stretching, for 10 minutes, for the main muscle groups.
15751870|NCT04844489|Other|Blood samples for the study of the humoral response to SARS-CoV-2 variants and of the cellular response after vaccination against COVID-19|"Blood samples at:
~D0 (the day of the injection of the SARS-CoV-2 vaccine),
~during the 2nd injection as part of the national vaccination campaign (on D28)
~during the 3rd injection for patients for whom a third injection is recommended (according to the recommendations in force)
~then to M1, M6 and M12 of the last injection"
15751875|NCT04844437|Diagnostic Test|Transperineal ultrasound|The fetal head station is evaluated by transperineal ultrasonography in valsalva.
15751879|NCT04844398|Other|Clown visits by RED NOSES Clowndoctors Austria|Participants will receive one clown visit per week over four weeks in a group setting. The visits will take place in at least two different wards of each participating psychiatric care facility. In each ward, max. 10 participants will be targeted. The visits are carried out routinely by two professional clown artists from RED NOSES Clowndoctors Austria. The duration of the visits and the specific artistic sequences will take place according to internally organized routines. The essence of the clown visit is to catch the patient's attention proactively and reach the highest level of engagement possible. The specific artistic sequences are implemented spontaneously according to the situational atmosphere and current mood of participants. One clown visit will last between 1 and 2 hours depending on age and number of participants. Each participant will be engaged between 5 and 10 minutes by the clown. The clown artists are not involved in any study-related research activities.
15751880|NCT04844385|Drug|Toripalimab|Toripalimab 240 mg, d1, Q3w for two cycles
15751881|NCT04844385|Drug|Paclitaxel-albumin|Paclitaxel-albumin 260 mg/m2, d1, Q3w for two cycles
15751882|NCT04844385|Drug|Nedaplatin|Nedaplatin 75mg/m2, d1, Q3w for two cycles
15751883|NCT04844385|Radiation|SMART|Once-daily simultaneous modulated accelerated radiotherapy (PTV-GTV: 60Gy/24f )
15751884|NCT04844385|Drug|Capecitabine|Capecitabine 1000 mg/m2, bid, d1-14, q3w during radiotherapy
15751885|NCT04844346|Dietary Supplement|Plant stanol mini drinks|Oat milk based mini drinks (100 mL) containing 2g plant stanols each (delivered as plant stanol esters).
15751886|NCT04844346|Dietary Supplement|Placebo mini drinks|Oat milk based mini drinks (100 mL) without added plant stanols (delivered as plant stanol esters).
15751887|NCT04844346|Biological|COVID-19 vaccine|First dose of one of the COVID-19 vaccines. Participants have to wait until they are invited to receive the vaccine by the government; this study does not interfere with national planning of the vaccines.
15751888|NCT04844333|Other|Extubation under deep anesthesia|When the patient in sedation or anesthesia state, no body movement, bispectral index 60-70, spontaneous breathing recovery, VT ≥ 5ml / kg, respiratory rate 10-20 times / min, regular rhythm, PetCO2 < 45mmhg, regular waveform, stable circulation, the patient is in deep anesthesia state, and the endotracheal tube is removed.
15751889|NCT04844320|Diagnostic Test|Cobb angle measurements|PA Chest x-rays will be taken in all patients in the preoperative, postoperative 1st year and 2nd year
15751890|NCT04844307|Other|Shorter duration higher frequency PT|The standard PT session (30 mins) will be divided into two 15 minute sessions spread out during the day. Therefore, the total number of minutes of PT will not vary from the standard.
15751891|NCT04844307|Other|Standard PT|The standard PT session is 30 minutes once daily. It routinely involves exercises designed to strengthen and increase mobility of the patient such as bed mobility, transfers, and ambulation. In this study group there will be no variation from this standard treatment.
15751920|NCT04844034|Other|Placebo|"Three capsules with the largest meal of the day providing:
~3,060 mg sunflower seed oil
~60 mg lecithin
~300 mg glyceryl monostearate
~465 mg EPA/DHA (18%/12% respectively for blinding)"
15751892|NCT04844294|Behavioral|Brief Cognitive Behavioral Therapy (BCBT)|BCBT is divided into three phrases. In phase I (5 sessions), the therapist conducts a detailed assessment of the patient's most recent suicidal episode or suicide attempt, identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills such as relaxation and mindfulness. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.
15751893|NCT04844294|Behavioral|Present-Centered Therapy (PCT)|PCT includes (1) psychoeducation about the typical symptoms and features associated with suicidal thoughts and behaviors; (2) normalization of symptoms; (3) experience of receipt of support and feedback from a licensed professional; and (4) positive interpersonal interactions. PCT differs from BCBT in several key ways including less structure (i.e., patients are allowed to have more input into PCT session agendas) and no systematic training in behavioral or cognitive strategies for managing emotions and changing suicide-focused thoughts. PCT will be used as an active comparator because it is an empirically supported treatment for depression and PTSD that also reduces suicidal ideation (Bryan et al., 2016; Resick et al., 2017), but contains unique elements that distinguish the treatment from BCBT.
15751895|NCT04844268|Biological|Cohort 1 VACINA RNA MCTI CIMATEC HDT vaccine|Intramuscular injections of 1 µg of novel Lipid-Inorganic Nanoparticle (LION) formulated replicating RNA-based vaccine (VACINA RNA MCTI CIMATEC HDT) at a dose of 1 µg on days 1 and 28 (group 1) or 1 and 56 (group 2), or a schedule of single dose administration (group 3).
15751896|NCT04844268|Biological|Cohort 2 RNA VACINA MCTI CIMATEC HDT vaccine|Intramuscular injections of 5 µg of novel Lipid-Inorganic Nanoparticle (LION) formulated replicating RNA-based vaccine (VACINA RNA MCTI CIMATEC HDT) at a dose of 5 µg on days 1 and 28 (group 1) or 1 and 56 (group 2), or a schedule of single dose administration (group 3).
15751897|NCT04844268|Biological|Cohort 3 VACINA RNA MCTI CIMATEC HDT vaccine|Intramuscular injections of 25 µg of novel Lipid-Inorganic Nanoparticle (LION) formulated replicating RNA-based vaccine (VACINA RNA MCTI CIMATEC HDT) at a dose of 25 µg on days 1 and 28 (group 1) or 1 and 56 (group 2), or a schedule of single dose administration (group 3).
15751898|NCT04844268|Biological|Placebo|Intramuscular (IM) injection of saline (0.9% sodium chloride) on days 1 and 28 (group 1) or 1 and 56 (group 2), or a schedule of single dose administration (group 3), in each cohort.
15751899|NCT04844255|Dietary Supplement|dietary salt|2 grams of dietary salt
15751900|NCT04844229|Procedure|Bilateral transnasal sphenopalatine ganglion block.|SPG block will be performed with the patient in supine position using cotton-tipped plastic hollow applicator inserted in the nose with the swab soaked in 1.5 ml 10%lignocaine. The applicator will be inserted parallel to the floor of the nose until resistance encountered. The swab will be rested in the pterygopalatine fossa superior to the middle turbinate and removed after 10 min. This procedure will be repeated in the other nostril too.
15751901|NCT04844229|Procedure|Bilateral ultrasound guided greater occipital nerve block.|GONB will be performed with the patients lying in prone position using high frequency (6-13 MHz) probe of Siemens Acuson X300 machine placed in transverse orientation lateral to external occipital protuberance parallel to the superior nuchal line to detect occipital artery where the nerve is located medial to it 1.5inch; then 20 gauge needle will be inserted out of plane to avoid vascular injury. 4 ml of treatment solution containing 2.5 mg/ml bupivacaine and 1 mg/ml dexamethasone (prepared by adding 2 ml bupivacaine 0.5% + 1 ml dexamethasone + 1 ml saline) will be injected on each side.
15751902|NCT04844216|Device|STYLAGE® L Lidocaine|An injection of maximum 2 mL on one nasolabial fold is planned at Day 0. A touch-up of maximum 1 mL on the same nasolabial fold is possible 1 month after D0 (month 1).
15751903|NCT04844216|Device|Active control|An injection of maximum 2 mL on one nasolabial fold is planned at Day 0. A touch-up of maximum 1 mL on the same nasolabial fold is possible 1 month after D0 (month 1).
15751904|NCT04844203|Diagnostic Test|Polygraphy with surface electrodes|Patients referred for ENMG to the Clinical Physiology Department and complaining of postural unsteadiness will undergo a polygraphy recording using surface electrodes (Natus Medical Incorporated), performed at the end of ENMG
15751905|NCT04844190|Diagnostic Test|EndoFLIP|During pre-G-POEM upper endoscopy, an EndoLIP catheter will be inserted through the patient's mouth into the stomach and across the pylorus. Once results of EndoFLIP are obtained, the catheter will be removed (5 minutes).
15751906|NCT04844190|Diagnostic Test|Antroduodenal Manometry|Following removal the EndoFLIP catheter, a manometry catheter will then be placed through the nose and advanced across the pylorus. Once catheter positioning is confirmed on endoscopy, the endoscope will be withdrawn. The manometry catheter will be taped to the nose and sedation stopped. The patient will be brought to the recovery area where they will wake-up with the catheter in place. In a private recovery room, the patient will have the catheter in place (no positioning or movement restrictions). When pyloric spasms are documented (0.5-4 hours), they will be given a standard small meal (water, toast/bread). Once motility is assessed with eating, the manometry catheter will be removed.
15751907|NCT04844177|Other|conditioning with TLI|"Total lymphoid irradiation 4 Gy (days -7, -6) in combination with:
~Fludarabine 150 mg/m2 (days-6, -5, -4, -3, -2)
~Cyclophosphamide 120 mg/kg (days -5, -4, -3)
~Thymoglogulin (Genzyme) 5 mg/kg (days -5, -4)
~Melphalan 180 mg/m2 (day -2)
~Rituximab 100 mg/m2 (day -1)
~Hematopoietic stem cell graft infusion after TCRab/CD19 depletion - day 0"
15751908|NCT04844164|Drug|Cholecalciferol 15000 UNT/ML Oral Solution|A single dose (150,000 IU) of cholecalciferol aqueous solution per os
15751909|NCT04844138|Behavioral|Overcoming Anxiety in Pregnancy and Postpartum Online Self-Directed Program|The investigators will administer the Overcoming Anxiety in Pregnancy and Postpartum program in an online self-directed format. This program is grounded in Cognitive Behavioural Therapy and will teach participants strategies to manage their anxiety. Participants will complete six modules that will be released to them on a bi-weekly basis.
15751910|NCT04844125|Drug|SHR-1209|SHR-1209
15751911|NCT04844125|Drug|SHR-1209 Placebo|SHR-1209 Placebo
15751912|NCT04844112|Procedure|automatic CT/MRI-US fusion system guided radiofrequency ablation|automatic CT/MRI-US fusion system guided radiofrequency ablation
15751913|NCT04844099|Drug|Dihydroartemisinin Piperaquine|Administered as dihydroartemisinin (20mg) and piperaquine (160 mg)
15751925|NCT04843982|Drug|Esketamine hydrochloride|After inclusion, septic patients will be received a single intravenous injection of esketamine (0.7 mg/kg), and then followed by an intravenous administration of esketamine (0.07 mg/kg/h) with an infusion pump for three consecutive days.
15751926|NCT04843969|Behavioral|Stress induction|Exposure to a psychosocial stressor
15751927|NCT04843969|Behavioral|Control stress exposure|Exposure to a control task (no stress)
15751928|NCT04843969|Behavioral|Cue induction|Exposure to a smoking-related task
15751929|NCT04843969|Behavioral|Neutral cue exposure|Exposure to neutral cues
15751930|NCT04843956|Diagnostic Test|Endoscopic ultrasound-guided biopsy|"Capillary with suction (puncture with gradual withdrawal of the stylet, applying dry suction with a 10 ml air vacuum syringe after removing the stylet)
~Capillary without suction (puncture with removal of the stylet gradually, without suction after removing the stylet)
~wet suction (Prior to puncture, the stylet is removed from the needle and irrigated with 1-2 ml saline solution to replace the air column with liquid, then the solid lesion is punctured and suction is placed with a 10 ml vacuum syringe of air)"
15751931|NCT04843943|Drug|Sintilimab|Sintilimab: 200mg IV Q3W D1
15751932|NCT04843943|Drug|Bevacizumab Biosimilar|Bevacizumab biosimilar: 15mg/kg, IV, Q3W, D1
15751933|NCT04843930|Device|AKL-T01|AKL-T01 will be administered as a 6-week intervention. It is an algorithmically delivered iPad-based video game designed to improve cognitive health by targeting attention and attentional control processes.
15751934|NCT04843917|Diagnostic Test|Immunoglobulin G detection|Detection of immunoglobulin G against Spike Receptor Binding Domain against severe acute respiratory syndrome coronavirus 2
15751935|NCT04843904|Drug|Venetoclax|Tablet, taken by mouth
15751936|NCT04843904|Drug|Obinutuzumab|Given as an infusion into the vein (intravenous, IV).
15751937|NCT04843904|Drug|Rituximab|Given as an infusion into the vein (intravenous, IV).
15751938|NCT04843891|Drug|[64]Cu Macrin|Up to 15 mCi of [68Ga]CBP8 will be administered to each subject.
15751939|NCT04843878|Diagnostic Test|COVID Detect|The study is determining the efficacy of a new rapid COVID testing method.
15751940|NCT04843865|Dietary Supplement|Chinese Herbs|Chinese Herbs
15751942|NCT04843839|Drug|Nepafenac 0.1% Oph Susp|Nepafenac 0.1% eye drops - Allergan : Dosage- 1 drop QID for 6 months
15751943|NCT04843839|Drug|Refresh Tears 0.5% Lubricant Eye Drops|Refresh Tears 0.5% w/v eye drops - Allergan : Dose- 1 drop QID for 6 months
15751944|NCT04843826|Procedure|papilla reconstruction|subepithelial connective tissue graft for interdental papillary reconstruction around delayed
15751945|NCT04843813|Dietary Supplement|Lutein|Participants will consume daily soft gels containing the lutein supplement.
15751946|NCT04843813|Dietary Supplement|Placebo|Participants will consume daily soft gels containing the safflower oil.
15751947|NCT04843800|Procedure|Manual therapy|Acupuncture, Chiropractic are recognized complementary medicines and Therapeutic Massage is an alternative healing practice.
15751948|NCT04843787|Drug|SLV213|SLV213 oral capsule (200mg) BID
15751949|NCT04843787|Drug|SLV213|SLV213 oral capsule (400mg) BID
15751950|NCT04843787|Drug|SLV213|SLV213 oral capsule (800mg) QD
15751951|NCT04843787|Drug|Placebo|Placebo oral capsule (200mg) BID
15751952|NCT04843787|Drug|Placebo|Placebo oral capsule (400mg) BID
15751953|NCT04843787|Drug|Placebo|Placebo oral capsule (800mg) QD
15751954|NCT04843774|Drug|SARS-COV-2 mRNA Vaccine|Pfizer-BioNTech and Moderna messenger RNA (mRNA)-platform vaccines developed against SARS-CoV-2 virus will be given as standard of care (SOC)
15751960|NCT04843748|Device|cataract surgery and intraocular lens implantation - both eyes|cataract surgery and intraocular lens implantation for both eyes
15751961|NCT04843722|Biological|hAd5-S-Fusion+N-ETSD vaccine|Vaccine containing both full length wild type SARS-CoV-2 spike gene optimized for better spike protein expression, and full length wild type SARS-CoV-2 nucleocapsid gene modified to also contain an enhanced T cell stimulation domain (ETSD) to enhance cell-mediated immunity.
15751962|NCT04843709|Drug|MRG004A|Administrated intravenously
15751963|NCT04843696|Device|cuirass ventilator (cuirass diameter 21 cm or 34 cm, Dima Italia Srl.,Bologna, Italy)|the hospital-based NPV once per week in the maintenance program at least three times per month. The ventilator is set to the control model with a frequency of 12~15 cycles/min, 30% of the ratio of inspiratory time to total breathing cycle time (Ti/Ttot), and delivery of negative pressures ranging from -20 to -35 cm H2O.
15751964|NCT04843696|Behavioral|breathing training, and an educational program (relaxation techniques and a home pacing walking exercise)|breathing training, and an educational program (relaxation techniques and a home pacing walking exercise) Breathing training consisted of breathing techniques (pursued-lipped, controlled, and diaphragmatic breathing)
15751965|NCT04843683|Radiation|Stereotactic Ablative Radiotherapy|Stereotactic ablative radiotherapy (SBRT) is a type of radiation treatment that delivers precise, high dose radiation to targeted areas. In this study, a single treatment of SBRT will be delivered to the abnormal area of a participant's heart that is causing dangerous heart rate and rhythm changes (arrhythmia).
15751966|NCT04843670|Procedure|duodenopancreatectomy|resection of the head of the pancreas, the mower part of the biliary duct, and antrectomy
15751967|NCT04843657|Behavioral|Observation for symptom distress|Observation for symptom distress
15751968|NCT04843644|Dietary Supplement|honey|"Since the patient received radiation therapy, Taiwan Longan Honey has been used for a total of eight weeks.
~Understand the changes of oral mucositis and various symptoms during this period"
15751969|NCT04843644|Dietary Supplement|propolis|"Since the patient received radiation therapy, Taiwan green propolis has been used for a total of eight weeks.
~Understand the changes of oral mucositis and various symptoms during this period"
15751970|NCT04843644|Behavioral|Control|usual care
15751971|NCT04843631|Drug|BFI-751|Single use vial, solution
15751972|NCT04843631|Drug|EU-STELARA®|Pre-filled syringe, solution
15751973|NCT04843631|Drug|US-STELARA®|Pre-filled syringe, solution
15751974|NCT04843592|Device|SOKARY Mobile|Effectiveness of using SOKARY Mobile Application on compliance of patient with Type II diabetes
15751975|NCT04843579|Drug|Selinexor|Given as 60 mg oral capsule
15751976|NCT04843579|Drug|Clarithromycin|Given as 500 mg oral capsule
15751977|NCT04843579|Drug|Pomalidomide|Given as 4 mg oral capsule
15751978|NCT04843579|Drug|Dexamethasone|Given as 40 mg oral capsule
15751979|NCT04843566|Procedure|Transperineal MRI-guided prostate biopsy|Transperineal prostate biopsy will be performed under local anesthesia in the office. This approach avoids transrectal needle tracking.
15751980|NCT04843566|Procedure|Transrectal MRI-guided prostate biopsy|Transrectal prostate biopsy is currently the most popular approach to evaluate a positive screening test for prostate cancer.
15751981|NCT04843566|Drug|Antibiotic (prophylaxis)|"For men undergoing transrectal biopsy, antibiotic prophylaxis will be administered in accordance with guidelines from the American Urological Association (AUA).
~No antibiotic prophylaxis will be administered for men undergoing transperineal biopsy."
15751982|NCT04843553|Drug|Oral Nicotinamide|
15751983|NCT04843540|Drug|CTP-543|Rifampin as oral capsule
15751984|NCT04843527|Device|FreeStyle Libre System|FreeStyle Libre Flash Glucose Monitoring System
15751985|NCT04843527|Device|FreeStyle Libre System plus food app|FreeStyle Libre Flash Glucose Monitoring System and Smartphone Food Logging application
15751986|NCT04843501|Behavioral|CATCH My Breath (CMB) program for E-cigarette prevention among adolescents|CMB has 4 developmentally appropriate e-cigarette lessons, 20-30 minutes in each of 6th-8th grades. Strategies include small and large group discussions, parent interviews, role-plays, media literacy, and goal setting. E-cigarette focused science and humanities activities (2 per school year) are also provided. An informational tool kit will be provided to parents. Finally, 8 activity-based E-cig PE lessons are intended for either 7th or 8th grades, depending on school calendar. CMB provides study materials to teachers through an online access portal. A site-based management team will oversee program implementation. Teachers in CMB intervention schools will be provided with CMB-specific training for implementing the lessons with fidelity through a one-hour live webinar, offered at multiple times to accommodate teaching schedules. Project staff will meet routinely with participating schools to answer study questions.
15751987|NCT04843501|Behavioral|Texas Education Agency (TEA) required tobacco prevention program|The TEA tobacco prevention program is a state-supported program that meets the mandates of the state. It includes TEA developed online lessons and support materials and also includes elements of the CDC Know the Risks e-cigarette prevention program. This can be considered 'usual care'
15751988|NCT04843488|Procedure|Guided bone regeneration with a PTFE membrane|Xenograft bovine spongious bone substitute mixed with autogenous intraorally harvested particulated bone is used and spatially contained with a PTFE membrane secured with Ti pins and screws.
15751989|NCT04843488|Procedure|Guided bone regeneration with a PTFE+collagen membrane|Xenograft bovine spongious bone substitute mixed with autogenous intraorally harvested particulated bone is used and spatially contained with a PTFE membrane secured with Ti pins and screws and covered with a Collagen membrane subsequently.
15751990|NCT04843475|Diagnostic Test|Echocardiography|Trans-thoracic Echocardiography
15751991|NCT04843462|Device|edupression.com®|"Edupression.com® is an evidence-based self-help program that was developed for the treatment of mild to moderate unipolar depression. It is based on two core foundations, psychoeducation with elements of cognitive behavior therapy (CBT) and a mood chart. Both foundations are registered as a medical product. As such, detailed risk management documentation includes probability and severity of adverse events. Moreover, detailed strategies such as warnings were implemented in the software and documented accordingly.
~It can be used on a PC as well as on mobile devices (browser, app) at any time."
15751992|NCT04843462|Drug|Esketamine nasal spray|All patients included in this study are receiving esketamine nasal spray as treatment-as-usual
15751993|NCT04843449|Drug|ASC40|Oral tablets
15751994|NCT04843449|Drug|Itraconazole|Oral capsules
15751995|NCT04843449|Drug|rifampicin|Oral capsules
15751996|NCT04843436|Device|RASM Symani|Robotically Assisted Micro Surgery
15751997|NCT04843423|Drug|Cariprazine|"At the screening visit, those who are eligible will enter an open-label trial with cariprazine in doses ranging from 1.5mg to 3 mg. The study will begin with a single week of cariprazine 1.5 mg oral tablets. After the first week the participants' dosage may be increased up to a maximum of 3 mg daily. This dose will remain fixed after 4 weeks of treatment until week 8, at which time the medication will be discontinued.
~Because the drug is not yet available to market in Canada, participants will be dispensed the drug in appropriately labelled 7-day tablet containers with the appropriate dose, including 3 additional tablets to account for scheduling conflicts. Participants will be instructed to return the tablet containers at each Study Visit in order to assess drug compliance. They will then be newly dispensed the appropriate quantity according to their next scheduled study visit."
15751998|NCT04843410|Other|Hand-foot exercise|The experimental group will be taught a regular exercise program for 15 minutes twice a day. The sensory exercise ball required for exercise will be given to the patients by the researcher. In addition, visual training material will be provided for the exercise program so that the patient can repeat the training at any time to ensure the permanence of the patient education. The standard care protocol of the clinic will be applied to the control group.
15751999|NCT04843384|Other|Reiki|Reiki was performed according to the need of each patient and lasted an average of 20-25 minutes. After the procedure, the patients were left to rest for ten minutes. The researcher was focused in a neutral way on the sessions without the intention of healing. After the session, the patients were allowed to rest for ten minutes.
15752000|NCT04843384|Other|Sham reiki|With the Sham Reiki patients, a nurse without reiki training performed Sham Reiki randomly for approximately 20-25 minutes, following a protocol which did not include the body's energy centers or chakras.
15753223|NCT04832854|Drug|Tiragolumab|Tiragolumab 600 mg will be administered by IV infusion on Day 1 of each 21-day cycle.
15752001|NCT04843371|Diagnostic Test|Photoplethysmography|Photoplethysmography (PPG) is a non-invasive technique that can detect volumetric changes in the peripheral blood. It only requires skin contact and relies on light absorption. PPG is a good indicator of the cardiovascular dynamics in the human body. PPG has been incorporated into various new smartphones and wearable devices such as, smartwatches and fitness wristbands making it readily available to all consumers. This sensor can record biometrics such as, heart rate, blood pressure, oxygen saturation, etc.
15752002|NCT04843358|Behavioral|Emotional Disclosure|"The trial member will deliver instructions For the next three days, I want you to write about your experience with cancer. In your writing, I want you to really let go and explore your very deepest emotions and thoughts. It is critical that you delve deeply. Ideally, I would like you to write about those parts of the experience you found hard to share with others. Perhaps this will provide an opportunity to really examine those thoughts and emotions. You might tie your personal experiences to other parts of your life. How is it related to your family life, relationship with your spouse, your children, your sexuality, daily activities, hobbies, your past, your childhood, your work? These are just some examples."
15752003|NCT04843358|Behavioral|Non-Emotional Writing|"The trial member will deliver instructions were as follows. For the next three days, I want you to write about how you use your time. We are interested in everything you do during the course of a day. In your writing I want you to be completely objective. We are not interested in your emotions or opinions. Feel free to be as detailed as possible"
15752004|NCT04843332|Behavioral|Community Health Worker Support|For those in the experimental group, a community health worker will provide health education and support as described in the Community Health Worker Intervention arm.
15752006|NCT04843306|Behavioral|Biofeedback|Relaxation coaching will be used in this study.
15752007|NCT04843306|Behavioral|Active Breathing Control Technique|Active breathing control (ABC) requires patients to reproducibly perform multiple deep-inspiratory breath holds during treatment.
15752008|NCT04843293|Behavioral|Olfactory stimulation|Newborns in the experimental group will be given the smell of breast milk during 3 consecutive feedings and for 3 days in the morning. Smell stimulation will be started 1 minute before gavage feeding and the application of breast milk odor will continue until the feeding ends. A hand-cleaning researcher will drip 15 drops of breast milk on sterile gauze to apply the smell of breast milk. Sterile gauze dripped with breast milk will be placed as close to the newborn's nose as possible and not in contact with the newborn's skin. After the feeding of the newborn is completed, the application of the smell of breast milk will be terminated and the gauze will be removed from the incubator. A new sterile gauze will be used for each feeding, and these processes will be repeated with each smell stimulation for three days.
15752009|NCT04843280|Procedure|FORCE therapeutics (physical therapy)|6 weeks of internet based physical therapy following arthroscopic knee surgery
15752010|NCT04843280|Procedure|Traditional Outpatient Physical Therapy|6 weeks of outpatient physical therapy following arthroscopic knee surgery
15752011|NCT04843267|Drug|Tislelizumab|Tislelizumab in first-line treatment of Hodgkin's lymphoma
15752012|NCT04843228|Behavioral|Cognitive Bias Modification|There will be four sessions of CBM. Each session will consist of two different part. The first part of the intervention will be the training based on the ambiguous scenario paradigm for perfectionism developed by Dodd (2019). Participants will need to complete word fragments in the last part of the scenario to resolve the ambiguity of the scenario. Then, a comprehension question will be presented to them to underscore the interpretation condition. Feedback will be given after each question. For the second part of the intervention aimed to intervene intolerance to uncertainty, word sentence association paradigm for intolerance to uncertainty developed by Oglesby (2017) will be used. In this intervention, participants will be asked to judge the relatedness of words and sentences which will be presented to them. Feedback will be given after each word-sentence.
15752013|NCT04843228|Behavioral|Cognitive Bias Modification for Control Group|For the first part of the intervention, the control group will be presented with the same procedures as the active group; however, feedbacks will be given to resolve the scenarios in a neutral way. When it comes to the second part of the intervention, different word-sentence pairings will be presented to the control group.
15752014|NCT04843215|Procedure|Type of omentectomy|Experimental group D2 radical gastrectomy with partial omentectomy. Partial omentectomy with preservation of the greater omentum at >3 cm from the gastroepiploic arcade.Control group with total omentectomy.
15752015|NCT04843189|Procedure|Da Vinci Robotic Surgery|Da Vinci Robotic Surgery
15752016|NCT04843176|Diagnostic Test|Prototype artificial intelligence algorithm|Developed by the University of Hong Kong
15752017|NCT04843176|Diagnostic Test|LI-RADS|The Liver Imaging Reporting and Data System (LI-RADS) was established to standardize the lexicon, interpretation and communication of radiological findings related to HCC
15752018|NCT04843163|Behavioral|NAMI Basics|NAMI Basics is a peer service program for caregivers of children with mental health needs. It was created by the National Alliance on Mental Illness (NAMI) and was adapted from their empirically supported model for caregivers of adult children with mental illness (Family-to-Family). The child-focused intervention, NAMI Basics, is a six-class curriculum focused on increasing caregiver knowledge about mental illness, empowering parents to advocate for their children across service systems, and introducing skills that assist in family problem-solving and communication (Brister et al., 2012). The program is currently available widely throughout the U.S. through certified trainers who volunteer with local NAMI affiliates and is provided free of charge to caregivers in a non-stigmatizing community setting (e.g., local school, church, community center). It is open to all caregivers, regardless of mental health diagnosis or time within a treatment system.
15752019|NCT04843137|Device|Cervical Transcutaneous Electrical Spinal Cord Stimulation|Surface electrodes are placed over the cervical spinal cord. Constant current is delivery through these electrodes. Stimulation frequency and electrode configuration are manipulated, and outcome measures are recorded.
15752020|NCT04843124|Device|Remote HA adjustment|The intervention group is offered remote hearing aid adjustment whilst the control group is offered traditional hearing aid adjustment the requires physical appointments at the clinic. Remote hearing aid adjustment is applicable through mobile applications that hearing aid users download to their mobile phones.
15752021|NCT04843124|Other|Traditional hearing aid|Traditional hearing aid
15753225|NCT04832854|Drug|Cisplatin|Cisplatin at 75 mg/m^2 will be administered by IV infusion on Day 1 of each 21-day cycle.
15752022|NCT04843111|Biological|Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine|Pharmaceutical form: Solution for injection Route of administration: Intramuscular
15752023|NCT04843098|Drug|TL117|TL117 capsules orally once daily
15752024|NCT04843098|Drug|Paclitaxel|Paclitaxel (80 mg/m2) administered intravenously (IV) on Days 1, 8, and 15 of a 28-day treatment cycle.
15752025|NCT04843085|Other|Proteomic analysis|: Proteomic analysis in the 3 subgroups of oligodendrogliomas (O1, O2 and O3) and in the comparator groups of IDH-mutant astrocytomas, IDH-wildtype glioblastomas and normal brain samples
15752026|NCT04843072|Device|Evolut R/PRO bioprosthesis|To compare Evolut R/PRO versus Sapien S3/Ultra in failing surgical bioprostheses
15752027|NCT04843072|Device|Edwards Sapien S3/Ultra bioprosthesis|Edwards Sapien S3/Ultra bioprosthesis
15752028|NCT04843059|Other|The resident memory T-cell infiltrate in perilesional vitiligo skin|"The 3 groups will receive a combination of narrowband UVB (Nb-UVB) 3 times a week and oral mini pulses of systemic steroids (5 mg of d medrol 16mg twice a week) for 24 weeks.
~Three visits will be done (inclusion, Week 12 and 24) A skin biopsy will be done on lesional and peri-lesional area at baseline. Another skin biopsy will be taken after 24 weeks but only in perilesional area. A blood sample for assessing the circulating memory T cells and for checking the tolerance will be performed at baseline, then at W12 and W24."
15752029|NCT04843046|Behavioral|Cognitive Behavioral Therapy (CBT)|All participants will receive evidence-based individual Cognitive Behavioral Therapy (CBT) shown to be an effective intervention for maintaining abstinence following detoxification. Trained masters-level licensed professional counselors will deliver CBT.
15752030|NCT04843046|Drug|Pioglitazone|Pioglitazone capsules will start at 30 mg (Detox days 3 and 4) and increase to fixed dose of 45 mg for study weeks 1-12 and will also contain riboflavin.
15752031|NCT04843046|Drug|Placebo|Placebo capsules will be filled with corn starch and riboflavin.
15752032|NCT04843033|Drug|SH3809 tablet|Starting dose 2mg,oral administered once daily. If tolerated subsequent cohorts will test increasing doses (4mg,6mg,8mg,10mg,12mg) of SH3809.
15752033|NCT04843020|Drug|ION 682884|Subcutaneous injection every month
15752034|NCT04843007|Drug|Pemetrexed|Alvopem® was administered every 3 weeks with a dose of 500 mg/m2
15752035|NCT04842994|Device|IONM tube|The standardized technique of IONM-RLNs (bilaterally) will be used, including indirect vagal response evaluation at the beginning and also at the end of surgery according to the recommendations formulated by the International Intraoperative Neural Monitoring Study Group (INMSG) (Randolph GW, Dralle H. 2011).
15752036|NCT04842981|Drug|Tocilizumab|Tocilizumab and Sarilumab are considered equal. Patients are assigned the treatment based on national and local guidelines. Intervention will be administered according to the approved posology.
15752037|NCT04842981|Drug|Sarilumab|Tocilizumab and Sarilumab are considered equal. Patients are assigned the treatment based on national and local guidelines. Intervention will be administered according to the approved posology.
15752038|NCT04842968|Other|Methylene blue injection|Methylene blue solution is injected ex vivo in the main supplying artery trunk of the freshly removed colorectal specimen. (50 mg in 30 ml saline)
15752039|NCT04842955|Device|Gamma tACS (40 Hz) over the superior parietal cortex|Single session of gamma tACS (40 Hz) over the superior parietal cortex
15752040|NCT04842955|Device|Sham tACS over the superior parietal cortex|Single session of sham tACS over the superior parietal cortex
15752041|NCT04842942|Procedure|TOETVA|Transoral Endoscopic Thyroidectomy Vestibular Approach
15752042|NCT04842929|Device|Transcranial magnetic stimulation|The coil will be positioned in the prefrontal dorsolateral cortex, with intermintent TBS (TBSi) mode on the left and continuous TBS (TBSc) on the right. 1800 pulses will be used on each side, totaling 10 minutes of total duration. There will be 20 consecutive sessions, one per day, except on weekends and holidays, totaling around 4 weeks. A day of stimulation with the same technique will be done in the 6th week, 8th week and 12th week.
15752043|NCT04842903|Other|Therapeutic Touch|Therapeutic touch is an energy transfer process based on the assumption that every living organism in the universe has an energy field and these energy fields that interact with each other can be changed with the practices made by a conscious and certain intent. TT is an independent nursing practice first applied and developed by nurses Dora Kunz and Dolores Krieger in 1972. TT is also an art of concentration therapy in which the therapist focuses on consciousness as a focus to create balance and coordination in the mutual energy fields of the patient and the environment, and uses their hands to transfer energy. The fact that TT is easy to use, has no known side effects, has low costs, is non-invasive, and its importance among nurses and increasing frequency of its practice in recent years show that it is a powerful alternative to other CAT methods.
15752044|NCT04842890|Radiation|Pencil Beam Scanning Proton SBRT|The intervention being investigated is ultra-hypofractionated, image-guided, pencil beam scanning proton SBRT directed at the prostate gland and seminal vesicles to 40 Gy equivalent in 5 fractions, delivered every other day.
15752045|NCT04842877|Drug|Valemetostat tosylate|200mg QD continuously until disease progression, consent withdrawal, unacceptable drug-related toxicity, lost to follow-up, major protocol deviation, pregnancy, termination by sponsor or death, whichever occurs first.
15752046|NCT04842864|Behavioral|Fasting|23 hours fasting
15752047|NCT04842851|Device|cardiac resynchronization therapy|Cardiac resynchronization therapy in patients with systemic right ventricle
15752048|NCT04842838|Device|paclitaxel DCB|Drug-coated balloon is a new kind of coronary interventional device. The balloon coated with anti-cell proliferation drugs (paclitaxel, etc.) is sent to the stenosis site. The balloon is closely adhered to the vascular wall during the expansion, and the drug is rapidly and evenly coated on the disaffected vessels.In recent years, DCB has gradually become an alternative for the treatment of in-stent restenosis (ISR), small vessel disease (SVD) and bifurcation disease.
15752049|NCT04842838|Device|DES|Provisional T technique is the preferred method for the treatment of bifurcation lesions with the existing stent.According to the 2018 European Guidelines on revascularization and the consensus group of the European Bifurcation Club (EBC), Provisional T technique is still the first choice for the treatment of Bifurcation, despite the problems related to side branches.
15752233|NCT04841161|Behavioral|Weight- distribution and weight-shifting training program|The stroke patients received a weight-shifting training program , 30 minutes/time, 2-5 days a week for 2-3 weeks(8 sessions). After training, they accepted a post-test within a week.
15752050|NCT04842825|Drug|Er Zhi Wan combined with Si Wu Tang|"The TCM medicines used will be Radix et Rhizoma Ligustrum 15 g, Radix Morindae Sinensis 12 g, Fructus Lycii 15 g, Semen Cuscutae 20 g, Radix Rehmanniae 20 g, Radix Angelicae Sinensis 10 g, Radix Paeoniae Alba 12 g, Radix Yam 20 g. The hospital will be responsible for the decoction of 200 mL per dose, 1 dose per day, divided into 2 doses in the morning and in the evening, for 10-15 days. According to follicular development and endometrial growth monitored by ultrasound, the herbs will be changed to Curculus 10 g, Xianling spleen 15 g, Morinda officinalis 15 g, Cuscutae 20 g, Amethyst 15 g, Rehmannia 20 g, Angelica 15 g, Chuanxiong 10 g，which will be taken for 10-15days.
~After ET, the treatment group will continue to take Chinese herbal medicine, changing to Cuscuta 15 g, Sambucus 15 g, Chuan Guan Gong 10 g, Agaricus 9 g, Shu Di 15 g, Angelica 10 g, Bai Shao 12 g for 14 days"
15752051|NCT04842825|Drug|Recombinant Human Follitropin Alfa 、Fructose 、Tetyacycline Hydrochloride Capsules、Cetrorelix Acetate Powder|The control group will be treated with conventional Western medicine（The specific drug dose is determined according to the individual level of patients）
15752052|NCT04842812|Biological|TILs and CAR-TILs targeting HER2, Mesothelin, PSCA, MUC1, Lewis-Y, GPC3, AXL, EGFR, Claudin18.2/6, ROR1, GD1, or B7-H3|TILs and CAR-TILs injection: 1-10×10e7/kg cells for each treatment; 3 or more cycles.
15752053|NCT04842799|Other|Digital Delivery of Pre-Genetic Testing Information via the BRCA-DIRECT Platform|"Participants will receive a link to the digital pre-test information. This will consist of text covering: Genetics and cancer risk; Genetics testing; What will happen if your test is positive; What will happen if your test is negative; Implications for insurance.
~Where relevant, parts of the text will be linked through to additional information, such as insurance advice from the Association of British Insurers. Participants will be able to call a genetic counsellor on the hotline during weekday office hours, should they have any questions or require further information."
15752054|NCT04842799|Other|Digital Delivery of Genetic Test Results via the BRCA-DIRECT Platform|Participants will receive a digital message that their results are available. When they click this, they will receive digital notification of their negative (normal) result in short form. Full details will be provided in an individualised letter.
15752055|NCT04842786|Other|Coconut oil|Coconut oil, Parachute oil composition: 92% lauric (C12) fatty acid, 6% oleic fatty acid, 2% linoleic fatty acid
15752056|NCT04842773|Diagnostic Test|Ultrasound measurement|Ultrasound measurement of sarcopenia in an elderly population
15752058|NCT04842734|Other|Physical exercise|Exercise sessions are planned for 12 weeks, 2 times a week, once a day, 60 minutes / 1 hour
15752059|NCT04842734|Other|Physical exercise and computerized cognitive training|Exercise sessions are planned for 12 weeks, 2 times a week, once a day, 60 minutes / 1 hour. The cognitive stimulation program is planned for 12 weeks, 5 days a week, approximately 10 minutes, for a total of 40 sessions
15752060|NCT04842721|Drug|Hypertonic Saturated Saline Mouth Rinse Active Arm|Each Patient of this groups will be asked to keep the solution still in his/her mouth, close to the back of the mouth, for 30 minutes without gargling and without swallowing. After 30 minutes the solution will be spit out and mouth will be rinsed with plain water several times. The process will be done twice a day for 2 days.
15752061|NCT04842721|Other|Placebo Plain Water Mouth Rinse Arm|Each Patient of this groups will be asked to keep the water still in his/her mouth, close to the back of the mouth, for 30 minutes without gargling and without swallowing. After 30 minutes the water will be spit out. The process will be done twice a day for 2 days.
15752062|NCT04842708|Diagnostic Test|vaccination against COVID19|subjects will undergo breath biopsy sampling before, 4-7 days post-first vaccination dose, and 7-10 days post-second vaccination dose.
15752063|NCT04842695|Device|electroacupuncture group|compare the effectiveness of electroacupuncture on point B7 plus pelvic floor exercises versus pelvic floor exercises alone in women with urinary incontinence (UI) .
15752064|NCT04842682|Biological|Solo 0.3 group|"CD40.HIVRI.Env and Poly-ICLC (Hiltonol), respectively at 0.3 and 1.0 mg/injection, i.e. 1 ml subcutaneous route in right deltoid at weeks 0, 4 and 24
~Or, NaCl at 0.9%, i.e 1 ml subcutaneous route in right deltoid at weeks 0, 4 and 24."
15752065|NCT04842682|Biological|Solo 1 group|"CD40.HIVRI.Env and Poly-ICLC (Hiltonol), respectively at 1.0 and 1.0 mg/injection, i.e. 1 ml subcutaneous route in right deltoid at weeks 0, 4 and 24
~Or, NaCl at 0.9%, i.e 1 ml subcutaneous route in right deltoid at weeks 0, 4 and 24."
15752066|NCT04842682|Biological|Solo 3 group|"CD40.HIVRI.Env and Poly-ICLC (Hiltonol), respectively at 3.0 and 1.0 mg/injection, i.e. 1.2 ml subcutaneous route in right deltoid at weeks 0, 4 and 24
~Or, NaCl at 0.9%, i.e 1.2 ml subcutaneous route in right deltoid at weeks 0, 4 and 24."
15752067|NCT04842682|Biological|Combi 0.3 group|"CD40.HIVRI.Env and Poly-ICLC (Hiltonol), respectively at 0.3 and 1.0 mg/injection, i.e. 1 ml subcutaneous route in right deltoid; and combined with DNA-HIV-PT123 HIV-1 at 4.0 mg/injection, i.e. 1 ml intramuscular route in left deltoid at weeks 0, 4 and 24
~Or, NaCl at 0.9%, i.e 1 ml subcutaneous route in right deltoid and 1 ml intramuscular route in left deltoid at weeks 0, 4 and 24."
15752068|NCT04842682|Biological|Combi 1 group|"CD40.HIVRI.Env and Poly-ICLC (Hiltonol), respectively at 1.0 and 1.0 mg/injection, i.e. 1 ml subcutaneous route in right deltoid; and combined with DNA at 4.0 mg/injection, i.e. 1 ml intramuscular route in left deltoid at weeks 0, 4 and 24
~Or, NaCl at 0.9%, i.e 1 ml subcutaneous route in right deltoid and 1 ml intramuscular route in left deltoid at weeks 0, 4 and 24."
15752069|NCT04842682|Biological|Combi 3 group|"CD40.HIVRI.Env and Poly-ICLC (Hiltonol), respectively at 3.0 and 1.0 mg/injection, i.e. 1.2 ml subcutaneous route in right deltoid; and combined with DNA at 4.0 mg/injection, i.e. 1 ml intramuscular route in left deltoid at weeks 0, 4 and 24
~Or, NaCl at 0.9%, i.e 1.2 ml subcutaneous route in right deltoid and 1 ml intramuscular route in left deltoid at weeks 0, 4 and 24."
15752070|NCT04842669|Other|low level laser therapy|Endo-laser 422 with interchangeable laser probes will be used for the purpose. It is a 2-channel unit and is software operated. For treatment of small surfaces with mono laser there are diodes of 25, 100 and 500 milliWatt.Frequency will be adjusted to 500 Hz, dose 0.1/cm2 with time duration of 1-5 minutes.
15752071|NCT04842669|Other|Conservative treatment|(Topical ibuprofen gel) for muscle soreness will be provided
15752234|NCT04841148|Drug|HCQ|600 mg tablets twice daily D1-28 of each 28-day cycle
15752235|NCT04841148|Drug|Avelumab|10 mg/kg, IV, D1 and D15 of each 28-day cycle
15754887|NCT04818632|Drug|AZD9833|Part B: AZD9833 monotherapy dose expansion
15752072|NCT04842656|Other|Post isometric relaxation|Patients in group B will receive post isometric relaxation technique. Patient lying in supine position, with the treated leg is placed into flexion at the hip and knee, so that the foot rests on the table lateral to the contra lateral knee (the leg on the side to be treated is crossed over the other). Therapist places one hand on the contra lateral ASIS to prevent pelvic motion, while the other hand is placed against the lateral flexed knee as this is pushed into resisted abduction to contract piriformis (PIR MET). The starting position will be the 1st sign of resistance towards end range. Therapist Force will be same as patient's force. Initial effort is approximately 20% of patient's strength. Duration of contraction is 7-10 seconds with three repetitions
15752073|NCT04842656|Other|Active release technique alongwith conventional treatment|Patients in Group A will receive active release technique.ART will be applied with patient in prone lying, knee flexed at 90. The therapist will place his elbow tip on taut band of piriformisand direct pressure isapplied, patient is then asked to do internal rotation of hip, in order to achieve lengthening of the muscle. This will be repeated 5-7 times.
15752074|NCT04842643|Biological|IGSC 20% infusion|IGSC 20% infusion, The dose of IGSC will be established in previous study (TAK-664-3001)
15752075|NCT04842630|Drug|SHR-1916|All participants receive SHR-1906 alone
15752076|NCT04842617|Drug|SHR6390|SHR6390 combined with endocrine therapy
15752077|NCT04842617|Drug|placebo|placebo combined with endocrine therapy
15752078|NCT04842604|Drug|Glasdegib|25 mg or 100 mg tablet
15752079|NCT04842604|Drug|Azacitidine|100 mg/vial powder for 25 mg/mL suspension for injection
15752080|NCT04842591|Diagnostic Test|exercise echocardiography|All patients will undergo exercise echocardiography during a symptom-limited cardiopulmonary exercise test.
15752081|NCT04842578|Other|Cross- Section of CT Guided Anatomic Segmentectomy|The anatomic segmentectomy is base on the reading and comprehension of Cross- Section of CT.
15752082|NCT04842578|Other|3D simulation Guided Anatomic Segmentectomy|The anatomic segmentectomy is base on the overview of 3D simulation of pulmonary structure.
15752083|NCT04842565|Drug|Sintilimab|Sintilimab (200mg ivdrip D1 Q3W)
15752084|NCT04842565|Device|TACE|TACE will be performed by clinical demand, the interval between two TACEs is not less than 4 weeks.
15752085|NCT04842552|Drug|Hydralazine hydrochloride 25mg tablets|Hydralazine hydrochloride 25mg tablets three time daily for 365 days (one year)
15752086|NCT04842552|Drug|Placebo|Placebo
15752087|NCT04842539|Other|Fecal Microbiota Transplantation|In the Fecal Microbiota Transplantation procedure 100 ml volume of strained and filtered stool will be delivered through a nasojejunal tube.The recipient patient will be kept nil per oral for at least 4 hours prior to the stool instillation. 100 mL of freshly prepared stool suspension will be given.
15752088|NCT04842539|Other|Standard of care|Nutritional supplementation and other supportive measures as per standard guidelines
15752089|NCT04842526|Drug|Anlotinib and irinotecan combined with temozolomide|Anlotinib, 7mg/m2, PO, was given for 14 days and stopped for 7 days; Irinotecan, 50mg/m2, D1-5, IV; Temozolomide, 100mg/m2, d1-5, PO; Three weeks is a cycle.
15752090|NCT04842513|Drug|Multipeptide plus XS15|The vaccine will be applied by subcutaneous injection into the abdominal skin of the study patient. Vaccination will take place monthly (V1, V2 and V3). A total of three vaccinations will be performed. Peptide vaccines should be injected into the skin at the lower part of the abdomen of the patients. The exact site of vaccination (right or left) will be determined at the time of first vaccination and should not be changed during subsequent vaccinations.
15752091|NCT04842500|Behavioral|Demand Informed Moderator Analysis|This analysis is designed to determine the degree to which relative price, and the timing of extinction, interact to increase or abate responding during extinction (thereby highlighting mechanisms of control).
15752092|NCT04842487|Drug|R2-CHOP(Lenalidomide,Rituximab,cyclophosphamide，hydroxyldaunorubicin，Vincristine，Prednisone）)|Lenalidomide：25mg po QN,d1-10 Rituximab: 375mg/m2, ivdrip, d1 Cyclophosphamide: 750mg/m2, iv or ivdrip, d1 Hydroxyldaunorubicin: 50mg/m2, iv or ivdrip, d1 Vincristine： 1.4 mg/m2 , iv（max：2mg）, d1 Prednisone: 60mg/m2, po, d1-5 every 3 weeks was a course of treatment
15752093|NCT04842474|Other|Gaze stability exercises and balance exercises|Gaze stability exercises will be performed while patients are in a seated position. Each exercise will last for 30 seconds and be done in phases that included; eyeball movement, saccadic eye movement, pursuit eye movement, vergence eye movement, and vestibular-ocular reflex exercise. Balance exercises will be performed in a standing position including both static and dynamic training with or without closing eyes.
15752094|NCT04842448|Drug|Hyperbaric oxygen|Hyperbaric oxygen 240 kPa for 90 minutes (with 10 min compression time, 2 air bakes and 10 minutes decompression time).
15752095|NCT04842448|Procedure|Sham treatment|Sham treatment 134-120 kPa Air (with 5 min compression time, and 5 min decompression to 120 kPa, two air brakes will be reported to the subjects)
15752096|NCT04842435|Drug|COVID-globulin|"In a Stage 1 study, COVID globulin is administered to clinical study subjects randomized to groups 1, 2, or 3 by intravenous drip in one of three doses of 1 mL/kg, 2 mL/kg, or 4 mL/kg The initial drug administration rate is from 0.01 mL/kg to 0.02 mL/kg of body weight per minute for 30 minutes. If the drug is well tolerated, the rate of administration can be gradually increased to a maximum of 0.12 mL/kg of body weight per minute. In order to control the drug administration rate, infusion shall be performed with an infusion pump.
~In a Stage 2 study, COVID globulin is administered to clinical study subjects randomized to group 1 by intravenous drip at a dose found optimal based on the results of Stage 1 study."
15752097|NCT04842435|Drug|Placebo|"In a Stage 1 study, Placebo is administered to clinical study subjects randomized to groups 4 by intravenous drip at a dose of 1 mL/kg.
~The initial drug administration rate is from 0.01 mL/kg to 0.02 mL/kg of body weight per minute for 30 minutes. If the drug is well tolerated, the rate of administration can be gradually increased to a maximum of 0.12 mL/kg of body weight per minute. In order to control the drug administration rate, infusion shall be performed with an infusion pump.
~In a Stage 2 study, placebo is administered to clinical study subjects randomized to group 2 by intravenous drip at a dose equal to the study drug dose."
15752098|NCT04842422|Drug|Imiquimod 3.75% Cream|Imiquimod 3.75% Cream
15752099|NCT04842409|Radiation|Whole breast irradiation|Whole breast irradiation using an ultra-hypofractionated schedule (26 Gy in 5 fractions)
15752236|NCT04841148|Drug|Palbociclib|125 mg capsule daily, by mouth on D1-21 concurrently with Avelumab. Or 75 mg capsule daily, by mouth on D1-28 concurrently with HCQ.
15752100|NCT04842396|Other|Experimental:Motorized cycle ergometer|Cycling training on the MOTOmed Muvi for 20 minutes 3 days per week for 6 weeks. Moreover, control of adverse events throughout the trial was measured through the assessment and monitoring of vital signs before, during (within the first 10 minutes), and after the intervention sessions. Vital signs [heart rate (per minute), systolic and diastolic blood pressure (in millimeters of mercury, mm Hg), and oxygen saturation (in percentage)] were monitored by a nurse and a medical doctor using mobile finger pulse oximeters.
15752101|NCT04842383|Drug|Hemp Oil|Hemp oil extract rich in varins (THCV and CBDV) as well as cannabidiol (CBD) in combination with 3% peppermint oil extract
15752102|NCT04842370|Drug|PHI-101|PHI-101, oral, once-daily administration, consisting of 28-days per 1 cycle
15752103|NCT04842357|Other|standardised video concerning clinical skill|watching a video concerning clinical skills.
15752104|NCT04842344|Device|ECCO2R|extracorporeal carbon dioxide removal
15752105|NCT04842331|Drug|RESP301, a Nitric Oxide generating solution|Participants will receive institutional SOC for the treatment
15752106|NCT04842318|Drug|BR for 6 cycles +R for 8 cycles|The patients will be given Bendamustine (90mg/m2 d1,2, every 28 days for total 6 courses) combined with Rituximab (375mg/m2 d0, every 28 days for total 6 courses) followed by Rituximab (375mg/m2 d1, every 3 months for total 8 courses)
15752107|NCT04842318|Drug|RCHOP for 6 cycles +R for 8 cycles|The patients will be given RCHOP (Rituximab 375mg/m2 ivgtt, D0, Cyclophosphamide 750mg/m2, ivgtt D1, doxorubicin 50mg/m2,ivgtt D1, Vincristine 1.4mg/m2（max 2mg）, ivgtt D1 Prednisone 60mg/m2 （max 100mg）,PO,D1-D5 every 21 days for total 6 courses) followed by Rituximab (375mg/m2 d1, every 3 months for total 8 courses)
15752108|NCT04842318|Drug|R2 for 6 cycles + R2 maintenance|The patients will be given Lenalidomide (25mg/d, po, D1-10, every 21 days for total 6 courses) combined with Rituximab (375mg/m2 d0, every 21 days for total 6 courses) followed by Lenalidomide (25mg/d, po, D1-10, every 28 days for total 6 courses) combined with Rituximab (375mg/m2 d1, every 3 months for total 8 courses)
15752109|NCT04842305|Diagnostic Test|Blood- and saliva tests|Measurement of SARS-CoV-2 spike glycoprotein RBD antibodies in plasma and saliva
15752110|NCT04842292|Drug|Heparin|Nebulized heparin 25,000 units every 6 hours
15752111|NCT04842292|Drug|Placebo|Sodium chloride 0.9% every 6 hours
15752112|NCT04842279|Other|FACE-Q scale|"FACE-Q is a recently developed and validated patient reported outcome measure (PROM) tool that allows clinicians to assess patient perspectives after skin cancer surgery of the face.The PROM is used to assess the perspective and impact of skin cancer as well as its treatment on the patient's quality of life (QoL). Patients with skin cancer may have increased anxiety, social isolation, and cosmetic concerns after surgery. The FACE-Q utilizes five scales to measure the psychometric, QoL, patient experience, and cosmetic outcomes. Raw scores are transformed to a 0-100 scale with a higher score indicating a better outcome.
~Any studies using FACE-Q for facial surgery reconstruction at our center may be eligible for inclusion in the database"
15752113|NCT04842266|Device|IlluminOss Pelvic Implant for the Treatment of Impending and Actual Pathological Fractures in the Pelvis from Metastatic Bone Disease|The study design is prospective and single center with the purpose of evaluating the performance of the IlluminOss Pelvic Implant in the treatment of pain due to impending or actual non-displaced or minimally displaced pathologic fractures of the pelvis secondary to metastatic malignancy in skeletally mature adults.
15752114|NCT04842266|Device|IlluminOss Pelvic Implant for the Treatment of Geriatric Pelvic Fractures|The study design is prospective and single center with the purpose of evaluating the performance of the IlluminOss Pelvic Implant in the treatment of pain due to geriatric pelvic fractures.
15752115|NCT04842253|Device|High flow nasal cannula|HFNC during deep sedation undergoing radiofrequency ablation for atrial fibrillation.
15752116|NCT04842240|Procedure|Pre- or sub-pectoral implant based immediate breast reconstruction|All study participants will undergo skin sparing mastectomy (with or without nipple preservation) for breast cancer or for risk reduction. Patients will undergo immediate breast reconstruction using an implant or a tissue expander. The device will be placed in pre- or sub-pectoral plane which will be supported by mesh (Tiloop/Surgimend Acellular Dermal Matrix) and/or a dermal flap.
15752117|NCT04842227|Procedure|Nerve block|"Step 1: A small amount of local anesthetic (3-5cc of 0.5% ropivacaine) is administered under ultrasound guidance in the area of the supraclavicular nerve at the base of the neck under sterile conditions. This provides dense anesthesia of the skin and eliminates the need to introduce larger quantities of local anesthetic directly to the skin around the incision (usually 20mL).
~The second step involves introducing 10-15cc of 0.5% ropivacaine under ultrasound guidance into the compartment between the pectoralis major and minor muscles to anesthetize the medial and lateral pectoral nerves. NOTE: Usual care involves blind administration of local anesthetic diffusely to the tissues in this region without targeting any particular nerves, and requires larger volumes of anesthetic (40mL for the blind approach vs 10-15mL for the nerve block)."
15752118|NCT04842214|Behavioral|Oncological Rehabilitation|Multidimensional rehabilitation
15752119|NCT04842201|Drug|CM326|subcutaneous injection
15752120|NCT04842201|Drug|Placebo|subcutaneous injection
15752121|NCT04842188|Procedure|L-PRF with aPDT|surgical open flap debridement followed by L-PRF with aPDT
15752122|NCT04842188|Procedure|L-PRF|surgical open flap debridement followed by L-PRF alone
15752123|NCT04842162|Drug|indocyanine green|indocyanine green (INFRACYANINE© 25mg/10mL.[SERB - 40, avenue George V - 75008 Paris, France]).
15752124|NCT04842149|Dietary Supplement|Bif195 capsules|1 capsule daily for 8 weeks
15752125|NCT04842149|Dietary Supplement|Placebo capsules|1 capsule daily for 8 weeks
15752126|NCT04842136|Other|Scales and indexes|Patients with TMD regardless of diagnosis with sleep bruxism were assessed with the Jaw Function Limitations Scale (JFLS), Neck Disability Index (NDI), Pittsburgh Sleep Quality Index (PSQI), Fatigue Severity Scale (FSS), and Headache Impact Test-6 (HIT-6) scales.
15752127|NCT04842123|Diagnostic Test|Electrocardiogram|Simultaneous assessment of the heart rhythm determined from a 12-lead ECG and the Garmin ECG software algorithm heart rhythm classification on single-lead ECG data derived from the wearable device. All participants will record three simultaneous 12-lead and single-lead ECGs.
15752128|NCT04842110|Device|Experimental: eonTM FR 1064 nm device|The subject treatment area - abdomen, was treated with the 1064 nm wavelength laser.
15752237|NCT04841135|Other|Multiomics quantification|One time blood, stool and urine samples will be taken.
15792580|NCT04512105|Drug|Venetoclax|Given PO
15752129|NCT04842097|Behavioral|Mindfulness-based stress reduction|An online mindfulness-based stress reduction intervention will be administered in a group format of maximum 15 participants, once a week for 120 minutes for 8 weeks by an experienced therapist trained in MBSR. Sessions will include sitting and lying meditation, hatha yoga and a body scan where attention is sequentially focused on different parts of the body. Individual autonomous practice between 30-45 minutes, 6 times / week will also be recommended. To support individual autonomous practice, a daily diary and two guided videos (around 35 minutes/each) were created.
15752130|NCT04842084|Biological|Blood samples|sampling of 10 S-Monovette tubes (Sarstedt) 4.3 ml of blood specifically for the study representing a total blood volume of 43 ml
15752131|NCT04842071|Diagnostic Test|18F-sodium fluoride|Intravenous injection of 4 MBq/kg for pediatric patients, or 5 MBq/kg for adult patients (maximum of 555 MBq), followed by a 45 minutes waiting time. Patients is then placed in supine position in a PET/CT scanner for a duration of no more than 30 minutes.
15752132|NCT04842058|Other|Mobilisation procedure|A standardized mobilization procedure was performed preoperatively ~ 1h before surgery and was repeated 6h and 24h after surgery. The mobilization procedure included patient supine rest (5 minutes), followed by 45° passive leg raise (PLR) (3 minutes), supine rest (5 minutes), sitting on the edge of the bed with feet resting on the floor (3 minutes) followed by standing using a walker while the patient was encouraged verbally to stand on toes and shift body weight from one leg to the other (3 minutes) and finally rest in supine position (5 minutes). The procedure was terminated prematurely in any position if patients experienced unbearable symptoms of OI or upon a decrease of systolic arterial pressure (SAP) > 30 mmHg.
15752133|NCT04842045|Drug|Psilocybin and Midazolam|"The psilocybin used in this study is synthetically manufactured in a laboratory and meets quality specifications suitable for human research use. The active drug is encapsulated using a hydroxypropyl methylcellulose (HPMC) capsule and contains 25 mg of psilocybin.
~The midazolam in this study will be administered intravenously. The total dose administered to subjects is dependent on the individual's level of amnesia, sedation scale,score and age and weight. For participants who remember ≥ 25% of the words (insufficient amnesia), midazolam dose will be increased to the high dose schedule. In terms of sedation, for participants who are overly sedated (OAA/S <4), the midazolam dose will be decreased to the low dose schedule. In situations in which the participant demonstrates amnesia but over-sedation, the low-dose schedule will be employed to increase the likelihood that a full psychedelic experience will occur."
15752134|NCT04842032|Drug|KRN23|KRN23 is a sterile clear colourless and preservative free solution supplied in single use 5 mL vials containing 1 mL of KRN23 at a concentration of 30mg/mL
15752135|NCT04842019|Drug|KRN23|KRN23 is a sterile clear colourless and preservative free solution supplied in single use 5 mL vials containing 1 mL of KRN23 at a concentration of 30mg/mL
15752136|NCT04842006|Drug|Total neoadjuvant therapy (TNT)|Short radiotherapy (5X5 Gy) and capecitabine/oxaliplatin
15752137|NCT04842006|Diagnostic Test|Minimal residual disease (MRD)|Postoperative MRD on circulating cell-free DNA
15752138|NCT04842006|Radiation|Long radiation therapy|Long-course 50.4 Gy radiation with capecitabine
15752139|NCT04841993|Drug|Cannabis decoction|A single 100 mL dose of cannabis decoction is administered containing 1.8 mg THC and 2.7 mg CBD.
15752140|NCT04841993|Drug|Cannabis oil|A single administration of 15 drops (045 mL) of cannabis oil containing 1.8 mg THC and 3.8 mg CBD.
15752141|NCT04841993|Drug|Vaporized cannabis|100mg of vaporized cannabis is administered by Volcano vaporizer, wich containing 0.6-2 mg THC and 0.8-3 mg CBD
15752142|NCT04841980|Drug|Rifaximin|Administration route: PO Rifaximin 400mg TDS for 2 weeks
15752143|NCT04841980|Other|Low FODMAP diet|Low FODMAP diet under dietitian guidance for 4 weeks
15752144|NCT04841967|Behavioral|TELL Tool Intervention|A 60-minute session with decision support information delivered digitally to parents at their homes or other private, quiet location.
15752145|NCT04841967|Behavioral|eBook Attention Control|A 60-minute session with good parenting principles delivered digitally to parents at their homes or other private, quiet location.
15752146|NCT04841954|Diagnostic Test|hemp prick-test|hemp seed and flower prick-test
15752147|NCT04841941|Device|G4 Multifocal soft contact lens with a 54% water content for presbyopia|"The participants must agree to wear lenses from a trial set with the fit assessed according to the Fitting Guide. Prescription lenses will then be ordered from the manufacturer."
15752148|NCT04841928|Behavioral|Mindful attention|The Mindful attention treatment component consists of a breathing exercise and is operationalized as two sessions (1 hour each) delivered over two weeks, i.e., one session per week, with homework between sessions. Sessions will be delivered online.
15752149|NCT04841928|Behavioral|Decentering|The Decentering treatment component consists of a guided imagery exercise and is operationalized as two sessions (1 hour each) delivered over two weeks, i.e., one session per week, with homework between sessions. Sessions will be delivered online.
15752150|NCT04841928|Behavioral|Value-based action|The Values and committed action treatment component consists of identification of personal values and committed action, and is operationalized as two sessions (1 hour each) delivered over two weeks, i.e., one session per week, with homework between sessions. Sessions will be delivered online.
15752151|NCT04841915|Dietary Supplement|High-Protein Diet|Diet consisting of 25E% from assigned protein during eucaloric diet and 35E% from assigned protein during hypocaloric diet
15752152|NCT04841915|Behavioral|Clinical dietician|Counselling from a clinical dietician bi-weekly until weight loss of 5% is achieved.
15752153|NCT04841915|Behavioral|Weight loss|4 weeks eucaloric diet ~13 MJ/day followed by, 20 weeks hypocaloric diet ~9 MJ/day until 5% weight loss is achieved.
15752154|NCT04841902|Other|Life Style Intervention Manual (With Exercise Under Supervision)|Life Style Intervention Manual for Pre Hypertensive subjects will consist of three components; Exercise, Dietary Modification and Education. The exercise will be supervised will other two components will be home based.
15752155|NCT04841902|Other|General Advice|General advice to stay healthy and active
15752156|NCT04841902|Other|Life Style Intervention Manual (Home Based)|Life Style Intervention Manual for Pre Hypertensive subjects will consist of three components; Exercise, Dietary Modification and Education. All three components will be home based.
15752238|NCT04841122|Device|Camera observation|Supplemental camera observation directly linked to the nurse's phone
15753226|NCT04832854|Drug|Pemetrexed|Pemetrexed at 500 mg/m^2 will be administered by IV infusion on Day 1 of each 21-day cycle.
15752157|NCT04841889|Diagnostic Test|Associated factors with decannulation|All factors potentially associated with successful tracheostomy removal will be prospectively collected: severity factors related to the ICU stay, ventilatory factors, respiratory and extra-respiratory factors. Lung and diaphragm ultrasound, swallowing, muscles and functional assessment will be performed.
15752158|NCT04841876|Other|rugby matches|standard rugby-7s match
15752159|NCT04841863|Device|MyPlan digital health platform|Inclusion in the active group involves the use of MyPlan digital health tool that aims to improve clinical-patient communication, enahnce patient empowerment, improve early detection of side effects and allows professionals to individualize interventions.
15752160|NCT04841863|Other|Satndard care|Inclusion in the control group do not involves the use of MyPlan digital health tool. Patients will receive the standard of care.
15752161|NCT04841850|Other|Clinical and biological characteristics|"Age at beginning of IOT
~Sex
~Atopic and non atopic Comorbidities
~Sensitization to aero-allergens
~Sensitization to trophallergens
~Stage of severity of the elicited reaction
~Hazelnut Specific IgE + Cor a 1,8,9,14 before IOT and during follow up
~Hazelnut skin prick test before IOT and during follow up
~Adverse effects of IOT and their stage (in hospital and at home)
~Use of adrenaline auto-injector (in hospital and at home)
~Maintenance dose"
15752162|NCT04841837|Behavioral|Time-restricted feeding|limit daily food intake to a period of 10 hours
15752163|NCT04841824|Other|Observational study|Observational study. Groups are defined based on baseline patients' characteristics : presence or absence of sepsis.
15752164|NCT04841811|Drug|Almonertinib|ctDNA dynamic monitoring guided the Almonertinib treatment group after surgery or radical radiotherapy
15752165|NCT04841798|Other|[11C]SL25.1188 PET radiotracer|Monoamine oxidase B (MAO-B) occupancy before and after medication treatment using [11C]SL25.1188 PET
15752166|NCT04841785|Diagnostic Test|mailer-based finger-prick|All participants in the antibody measurement study will be sent a mailer-based finger-prick set. The sets will be sent to the home address of the patient, including a return envelope. After collecting and returning the samples SARS-CoV-2 antibodies will be analysed quantitatively at the laboratory.
15752167|NCT04841772|Dietary Supplement|Recover Vegan Protein Supplement|Post exercise protein supplement (26g pea protein)
15752168|NCT04841772|Dietary Supplement|Placebo|Post exercise placebo supplement (32g maltodextrin)
15752169|NCT04841759|Other|Exercise|8 week exercise program, nutritional & psychological consultation
15752170|NCT04841746|Behavioral|Physical therapy that include a standardized cycling training with functional electrical stimulation|Immediately after the discharge of the intensive care unit, patient with a severe form of the COVID-19 will be admitted in the rehabilitation hospital. Rehabilitation will consist in physical therapy twice a day, 30 minutes, 5 days a week. One session will be dedicated to a standardized cycling training (TECHNOGYM RECLINE EXCITE 700). All participants will follow the same 4-week rehabilitation protocol representing a total of 1200 minutes. Participants randomized in the experimental group will received functional electrical stimulation administered to surface electrodes attached to lower limb muscles (quadriceps, hamstrings, gluteus maximus and triceps). Electrical stimulation will be delivered appropriately to the muscle during cycling regarding the angle of the pedal by a stimulator (Motimove-8 de 3Fit Fabricando Faber).
15752171|NCT04841746|Behavioral|Physical therapy that include a standardized cycling training with no additional functional electrical stimulation|Immediately after the discharge of the intensive care unit, patient with a severe form of the COVID-19 will be admitted in the rehabilitation hospital. Rehabilitation will consist in physical therapy twice a day, 30 minutes, 5 days a week. One session will be dedicated to a standardized cycling training (TECHNOGYM RECLINE EXCITE 700). All participants will follow the same 4-week rehabilitation protocol representing a total of 1200 minutes. Participants randomized in the control group will received no additional functional electrical stimulation during cycling.
15752172|NCT04841733|Other|Foam Roller (FR)|Foam Roller (FR): participants will follow the Foam Roller protocol using a polyvinylchloride pipe roller (10.3-cm diameter, 0.3-cm thickness surrounded by a 1,5-cm thickness neoprene foam). They will begin with the Foam Roller at the most proximal portion of the muscle and to roll as much body mass as tolerable back and forth along it as smoothly as possible at a cadence of 1 second superior and 1 second inferior as determined with the metronome. Foam Roller will be performed for 45 seconds followed by a 15-second rest for each muscle group (quadriceps, adductors, hamstrings, abductors and calf) in each extremity and repeated once.
15752173|NCT04841733|Other|Stretching (STR)|Stretching (STR): participants will perform 8-min of static stretching, involving 3 bilateral repetitions of 30 seconds held stretches to the quadriceps, adductors, hamstrings, abductors and calf muscles.
15752174|NCT04841733|Other|Cold-Water Immersion (CWI)|Cold-Water Immersion (CWI): will be the last strategy used. Participants will immerse their lower body to the level of the hips for 10 minutes in cold water (10° C).
15752175|NCT04841720|Drug|HSK16149|HSK16149 capsules for single use: D1-D4 oral HSK16149 capsules 80 mg BID, D5 only oral HSK16149 capsules 80 mg in the morning on an empty stomach; wash-out period is about 4 days (D5-D8);
15752176|NCT04841720|Drug|Metformin Hydrochloride tablet|Metformin hydrochloride tablets for single use: D9-D11 oral metformin hydrochloride tablets 500 mg BID, D12 only take 500 mg metformin hydrochloride tablets in the morning on an empty stomach; wash-out period is about 4 days (D12-D15);
15752177|NCT04841720|Drug|HSK16149+Metformin（phase 3）|Combined use of HSK16149 capsules and metformin hydrochloride tablets: D16-D19 oral metformin hydrochloride tablets 500 mg BID, D16-D19 oral HSK16149 80 mg BID; D20 oral metformin hydrochloride tablets 500 mg and HSK16149 capsules 80 mg in the morning on an empty stomach.
15752178|NCT04841707|Device|uEXPLORER/mCT|Each participant will undergo two 18F-FDG PET/CT scans, one at baseline and one at 4- month (+/- 2 weeks) follow-up.
15752179|NCT04841694|Dietary Supplement|Probiotic|Bacillus indicus
15752230|NCT04841200|Drug|Chinese medicine compound placebo combined with symptomatic treatments|"All patients were given symptomatic treatment according to consensus of Chinese experts on pneumoconiosis treatment (2018).
~There are 3 placebo Recipe for the 3 traditional Chinese syndrome.
~Yang Qing Chen Fei Granules placebo for syndrome of yin deficiency and heat-dryness, Bao Jin Chen Fei Granules placebo for syndrome of pulmonary qi deficiency, Jin Shui Chen Fei Granules placebo for syndrome of deficiency of pulmonary and renal qi
~All drugs were made into granules by Sichuan Neo-Green Pharmaceutical Technology Development Co., Ltd. The appearance, shape, color and packaging of Chinese medicine compound placebo are the same as those of drugs.
~Each type of granule will be given orally, twice a day, for 52 weeks."
15752180|NCT04841681|Behavioral|Video-based Psychotherapy|"Participants in the group watched three short videos. Therapeutic elements in the three consecutive short videos included relaxation therapy, managing thoughts and feelings, and mindfulness. Each video has a duration of just over 10 minutes.
~In the first video, the participants were introduced to the purpose and benefits of relaxation techniques. These included rhythmic breathing techniques, progressive muscle relaxation, imagining a comforting and quiet place, and positive self-talk. In the second video about managing thoughts and feelings, the participants were introduced to the notion of acceptance of their condition. They were invited to recognize the emergence of negative feelings and thoughts related to acceptance. In the last video about mindfulness, patients were introduced to three basic mindfulness skills: observation, elaboration, and participation."
15752181|NCT04841668|Drug|Metformin|Patients will begin treatment with metformin administered orally at a starting dose of 425 mg / day every 12 hours for the first 15 days and then continue with a dose of 850 mg / day until the end of the study. The beginning of this treatment phase will be following the recommendations of the clinical guidelines (Comprehensive Approach to Type 2 Diabetes Mellitus, SEEN V2019.2)
15752182|NCT04841642|Other|MANUAL THERAPY|The investigators will apply manual therapy for ten minutes a week, for 8 weeks, based on cervical mobilizations and suboccipital inhibitions.
15752183|NCT04841642|Other|THERAPEUTIC EXERCISE|"The exercises recommendations will be based on a simulation of the exercises in the same session of the manual therapy of each week, helped by the physiotherapist.
~The access to telerehabilitation will be through a web page, through which patients could see explanatory videos of the exercises as many times as they need."
15752184|NCT04841629|Other|PreBioGyn Gel|Cellulose-based prebiotic gel developed to optimize vaginal health and reduce the risk of cervical cancer in women.
15752185|NCT04841629|Other|Trimosan Gel|Carbomer-based gel
15752186|NCT04841629|Other|RepHresh Gel|Carbomer-based gel
15752187|NCT04841616|Procedure|Endoscopic Ultrasound -Guided Fine Needle Biopsy|Patients will undergo EUS FNB with the 22-gauge FNB needle (Acquire®, Boston Scientific Natick, MA). After each pass, the needle is removed and the stylet will be introduced into the needle to extrude any aspirated material on a glass slide for inspection of the presence of a macroscopic visible core (MVC). The total length of the MVC will be measured before placement into a formalin bottle. EUS-FNB is completed if the obtained MVC is longer than 4mm and deemed adequate by endoscopist. If the obtained MVC is < 4mm, the procedure is repeated until a MVC of ≥ 4mm is obtained and deemed adequate by endoscopist. A maximum of 7 passes is allowed.
15752188|NCT04841616|Procedure|Contrast-Enhanced Harmonic Endoscopic Ultrasound|After initial evaluation, 2.5ml of second-generation contrast media, SonoVueTM (Bracco, Ceriano Laghetto, Italy), will be injected. After infusion, the point of puncture will be determined when the parenchyma of the pancreas was enhanced. The contrast-enhanced area was identified and then the biopsy was directed toward that area, while avoiding unenhanced (i.e. necrotic) areas and not changing the target lesion. Rest of the procedure is identical with that in conventional EUS arm.
15752189|NCT04841603|Device|Mindshift CBT|A tablet with the Mindshift CBT app installed. Mindshift CBT is a free, evidence based app developed by Anxiety Canada, designed to help users reduce symptoms of anxiety and distress.
15752190|NCT04841603|Device|Treatment as Usual|Treatment as usual. A tablet identical to the intervention group, but without the Mindshift CBT app is available for patients to use during their inpatient stay.
15752191|NCT04841590|Other|Intervention of the experimental group (EG)|Treatment through the use of manual physiotherapy techniques such as mobilization techniques in the spinal column, cranial techniques and visceral mobilization applied by gentle pressure, according to the therapist's diagnostic criteria after performing palpatory and mobility tests.
15752192|NCT04841590|Other|Control Group (CG)|Subjects in the control group (CG) will not receive any treatment
15752193|NCT04841590|Device|Placebo Group (PG)|Subjects belonging to this group will receive the application of off ultrasound applied to the abdominal region for approximately 10 minutes
15752196|NCT04841564|Procedure|ultrasound approach of serratus anterior block|After induction of general anesthesia, the ultrasound probe will be placed longitudinally oblique just below the mid-clavicle. After identifying the second rib, the probe will be moved caudally and laterally (obliquely), towards the mid-axillary line to identify the 3rd, 4th and 5th ribs.. The fascial plane between the serratus anterior muscle and latissimus dorsi muscle will be identified over the 4th rib in the mid-axillary region. The block will be performed with a needle (22-G, 50-mm) introduced in-plane to enter deep to the serratus anterior muscle, and 30 ml 0.25 bupivacaine will be injected.
15752197|NCT04841564|Procedure|open approach of serratus anterior block|After resection of the breast and identification of the serratus anterior muscle, the surgeon will be asked to palpate the ribs below the clavicle and localize the fourth rib. A 22-G, 50-mm needle will be introduced deep to the serratus anterior muscle contacting the rib, and 30 ml 0.25 bupivacaine will be injected.
15752198|NCT04841551|Drug|Kybella Flanks|10 subjects will be treated with Kybella in the flanks
15752199|NCT04841538|Drug|ES101|The active ingredient of ES101 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.
15752201|NCT04841499|Drug|BASIS™ (Crystalline Nicotinamide Riboside 250mg and Pterostilbene 50mg)|take 2 capsules orally each day for 7 days
15752202|NCT04841486|Other|Data collection|evaluation of women's stress
15752203|NCT04841473|Other|TRAIN Concussion Education|Participants will receive the TRAIN concussion education module.
15752204|NCT04841473|Other|Standard Concussion Education|Participants will receive a standard concussion education module.
15752205|NCT04841460|Dietary Supplement|Low-fat ground beef|5% fat ground beef
15752206|NCT04841460|Dietary Supplement|High-fat ground beef|25% fat ground beef
15752207|NCT04841447|Other|Study sample collection|Peripheral blood draws and bone marrow aspiration will be done during clinic visit and hospital stay.
15753229|NCT04832841|Diagnostic Test|anti-spike SARS-CoV-2 IgG|Immunochemiluminescent assay by DiaSorin S.p.A. Italy
15752208|NCT04841434|Drug|Voraxaze Injectable Product|High-dose Methotrexat Infusion: MTX is given at a dose according to the allocated dose level cohort as a 4-hour IV infusion. HD-MTX cycles (up to 6) should be repeated every 14 days, provided that the patient has recovered (i.e., hematopoietic reconstitution) between cycles. A delay of up to 28 days between cycles is permitted in order to allow patients to recover from the preceding dose of MTX. In patients with a decline of the GFR to <40 mL/min, or in the case of decreased GFR, the decrease is >50% compared with the pretreatment value, treatment will be terminated. At the start of Cycle 3 the dose of MTX can be escalated to the next level if MTX has been well-tolerated according to the criteria described under dose escalation. Voraxaze: 2000 Units in patients weighing ≤100kg and at least 20 Units per kg body weight in patients weighing >100kg is given in each HD-MTX cycle as a slow IV injection at 24 hours (+/- 2 hours) after the start of HD-MTX infusion.
15752209|NCT04841421|Drug|89Zr-CD147|The 89Zr-CD147 is a promising positron emission tomography probe and it is possible to select suitable tumor patients with CD147 expression to benefit from anti-CD147 treatment.
15752210|NCT04841408|Other|Vaginal self-sampling|Vaginal self-sampling performed by the patient at the follow-up visit at 3 weeks and remote follow-up at 9 weeks.
15752211|NCT04841395|Diagnostic Test|Intravaginal ejaculatory latency time (IELT), Arabic Index of Premature Ejaculation (AIPE), Morningness-Eveningness Questionnaire (MEQ)|Self-estimated intravaginal ejaculatory latency time IELT is defined as the time between the onset of vaginal intromission and the onset of intravaginal ejaculation. In the present research, self-estimated IELT duration was obtained as a result of interviews with the participants. Moreover, Arabic Index of Premature Ejaculation (AIPE), International Index of Erectile Function (IIEF-5), Pittsburgh Sleep Quality Index (PSQI) and Morningness-Eveningness Questionnaire (MEQ) were administered to all participants.
15752212|NCT04841382|Other|Supporting information.|CardioSolv Software System is a software-based medical device meant which creates a patient-specific 3D heart model that provides physiologic information.
15752213|NCT04841369|Biological|13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）|0.5mL,Intramuscular
15752214|NCT04841369|Biological|13-Valent Pneumococcal Polysaccharide Conjugate Vaccine|0.5mL,Intramuscular
15752215|NCT04841356|Procedure|Immediate Compression Garment|"Immediately following surgery, in the operating room, the compression garment will be donned on the surgical limb. The garment is set to the following pressures to facilitate gradient compression: 40mm Hg (lower leg), 30mm Hg (knee), 20 mm Hg (thigh) utilizing a standardized garment tensioning tool. Subjects will wear the garment during all waking hours (target wear time of 12 hours daily) for the first 3 weeks after surgery. Additionally, subjects will be instructed to perform a therapeutic exercise program designed to manage swelling by targeting major lower extremity musculature (gastrocnemius, soleus, quadriceps, hamstrings, and gluteal musculature) and promoting venous and lymphatic return. These exercises will be performed five times daily during the first three weeks after surgery.
~Subjects will receive standard of care rehabilitation following surgery as directed and coordinated by the surgeon and participant. This rehabilitation is not part of this research study."
15752216|NCT04841343|Drug|Triamcinolone|Triamcinolone in sinus
15752217|NCT04841330|Device|Securis™ Stabilization Device|A trained clinician will apply and remove, and participants will wear the Securis™ Stabilization Device for up to one week (7 days) on their forearm. A shortened catheter will be placed (not inserted) over the Securis™ device in accordance with the product Information for Use (IFU), and an extension set attached to the catheter and secured in place, to simulate clinical use.
15752218|NCT04841317|Combination Product|Mobile technology intervention|Home blood pressure cuff used by patients twice a week, with blood pressures transmitted to providers remotely
15752219|NCT04841304|Device|Loop recorder (Reveal LINQ, Medtronic)|Implantation of a loop-recorder
15752220|NCT04841304|Device|Continuous Glucose Measurement (G6, Dexcom)|Monitoring with a continuous glucose monitor
15752221|NCT04841291|Behavioral|Diabetes Foot Care Education (DFCE)|Virtual simulation-based DFCE sessions on seven topics (the reasons for inspecting one's feet, risk factors and prevention strategies of diabetic foot ulcer, how to wash and moisturize feet, comfortable sock and shoe choices, what to look for, and what to do during feet inspection, how to trim fingernails, and how to maintain foot health) at University of Gondar computer lab for 30 minutes.
15752222|NCT04841278|Device|EUS/ERCP|EUS with possible interventions, including liver biopsy and/or cholangiography, and possible ERCP. No new experimental procedures are proposed, only new protocol for diagnosis and treatment of liver graft dysfunction.
15752223|NCT04841265|Dietary Supplement|Vitamin D3|The intervention arm will receive 400 IU vitamin D3 from routine antenatal multivitamin supplement tablet + 400 IU vitamin D3 daily until delivery.
15752224|NCT04841252|Device|FDA approved GE LOGIQ E9 (LE9) ultrasound|Ultrasound
15752225|NCT04841252|Device|Alpinion clinical ultrasound machine|Ultrasound
15752226|NCT04841239|Other|Herbal topical formulation|
15752227|NCT04841226|Device|Long-term indwelling Foley catheter|Foley Catheter inserted for up to 28-days
15752228|NCT04841213|Procedure|Dental implantation|Traditional 2-stage dental implantation according to surgical protocols of dental implant systems (Straumann (Institut Straumann AG, Switzerland), Astra Tech (Dentsply Implant Manufacturing GmbH, Germany), Xive (FRIADENT GmbH, Germany), Alpha Bio (Alpha Bio Tec Ltd., Israel) for different types of bone tissue
15752229|NCT04841200|Drug|Chinese medicine compound combined with symptomatic treatments|"All patients were given symptomatic treatment according to consensus of Chinese experts on pneumoconiosis treatment (2018).
~There are 3 Recipe for the 3 traditional Chinese syndrome.
~Yang Qing Chen Fei Granules for syndrome of yin deficiency and heat-dryness, Bao Jin Chen Fei Granules for syndrome of pulmonary qi deficiency, Jin Shui Chen Fei Granules syndrome of deficiency of pulmonary and renal qi
~All drugs were made into granules by Sichuan Neo-Green Pharmaceutical Technology Development Co., Ltd.
~Each type of granule will be given orally, twice a day, for 52 weeks."
15752231|NCT04841174|Other|Abdominal massage|The effect on gastric problems by applying abdominal massage to eligible participants in the study will be examined.
15752232|NCT04841161|Behavioral|Balance function, gait ability, weight- distribution and weight-shifting|Healthy adults and stroke patients accepted two measurements within a week. Balance function, gait ability, weight- distribution and weight-shifting during sit-to-stand, quite standing, and weight-shifting toward the forward foot.
15752239|NCT04841096|Drug|Glimepiride / Vildagliptin / Metformin (2 mg/ 50 mg/ 1000 mg)|Take one tablet of the prescribed dose of the investigational drug by mouth, preferably with food and in the morning
15752240|NCT04841096|Drug|Glimepiride / Vildagliptin / Metformin (4 mg/ 50 mg/ 1000 mg)|take one tablet of the prescribed dose of the investigational drug by mouth, preferably with food and in the morning
15752241|NCT04841083|Device|Allay Lamp|The Allay Lamp is a consumer product currently available and widely used in the US. It emits low intensity (1-10 lux) narrow band (20 nm) green light (peak wavelength 520 nm) that is marketed as non-irritating to users. In that context, it is not a medical device and does not require a 510(k).
15752242|NCT04841070|Other|Ages & Stages Questionnaires®, Third Edition (ASQ3)|Investigators will propose to parents of children hospitalized for the treatment of persistent pulmonary hypertension of the newborn a hetero-evaluation via the validated ASQ questionnaire to analyze neuro-psychomotor development.
15752246|NCT04841044|Dietary Supplement|Cetoleic acid|Very long monounsaturated fatty acid ( C22:1n-11)
15752247|NCT04841044|Dietary Supplement|Control Oil|Control oil consisting of: mix of anchovy oil, olive oil, high-oleic sunflower oil and rapeseed oil
15752248|NCT04841031|Behavioral|NET Treatment|Narrative Exposure Therapy (NET) aims to address PTSD symptoms among survivors of mass violence and torture (Onyut et al., 2004; Schauer, et al., 2005). Mainly, different from other psychosocial interventions which require the survivor to process a single traumatic event in his or her life at a given time, NET treatment recognizes that trauma survivors undergo multiple distressing events within their lifetime (Schauer et al., 2005). Focusing on the traumatic events, the patient constructs a chronological narrative of his or her life story and a coherent narrative is then structured with the assistance of the therapist. They received NET one to three months following their screening and randomization. The therapy involves 8 to 12 individual sessions of about 90 minutes each.
15752249|NCT04841031|Other|Alternative Intervention|Individuals in control group received non-NET psychosocial support in the interim that is provided to SGBV survivors as part of the Great Lakes SGBV project and will then receive NET after endline data has been collected.
15752250|NCT04841018|Drug|High dose dexamethasone|After caudal block with 1.2ml/kg of 0.15% ropivacaine, the patient receives 0.5mg/kg of intravenous dexamethasone
15752251|NCT04841018|Drug|Low dose dexamethasone|After caudal block with 1.2ml/kg of 0.15% ropivacaine, the patient receives 0.15mg/kg of intravenous dexamethasone
15752252|NCT04841005|Other|The Square-Step Exercise Training|The Square-Step Exercise is instructed to walk according to the step pattern shown on a 100 * 250 cm mat, divided into 40 squares of 25 cm each. It includes forward, backward, lateral and diagonal steps, and step patterns are progressively made more complex. Each pattern consists of two to 16 steps; Individuals are asked to repeat the step pattern until they reach the end of the mat. Each step pattern is repeated 4-10 times to ensure that individuals can complete the pattern. The individuals included in the study will exercise in easy-difficulty patterns for the first 2 weeks, medium-difficulty patterns in the 3rd and 4th weeks, medium and advanced patterns in the 5th and 6th weeks, and advanced patterns in the 7th and 8th weeks. The square-step exercise group will perform 15 minutes of warm-up exercise, 30 minutes of progressive square-step exercise, and 10 minutes of cool-down exercise accompanied by a physiotherapist, 3 days a week.
15752253|NCT04841005|Other|Strengthening Exercise Training|Thera-Band brand elastic bands will be used to apply resistance in strengthening training. To determine the intensity of the exercise, the perceived difficulty level after 15 repetitions with the elastic band will be evaluated with the Borg scale. If the perceived difficulty level is at the level of 12-14 (slightly difficult), it will be considered as the starting difficulty level.In the strengthening exercise group will perform, shoulder abduction, shoulder press after elbow flexion, horizontal abduction, punching with an elastic band, triceps strengthening, external rotation of the shoulder, hip abduction with external rotation and sit-to-stand exercises for 8 weeks, 3 days / week , 3 sets / sessions, 8-12 repetitions. For each exercise, it will be applied as 8 repetitions in the initial workload. In the next exercise sessions, the number of repetitions will be increased until the patient can comfortably perform 12 repetitions with the same load.
15752254|NCT04840992|Biological|Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) for Inhalation|Aerogen Solo
15752255|NCT04840992|Biological|Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)|Intramuscular administration
15752256|NCT04840992|Biological|Placebo for Inhalation|Aerogen Solo
15752257|NCT04840992|Biological|Placebo|Intramuscular administration
15752258|NCT04840979|Drug|11C-ER176|11C-ER176 is a novel TSPO radioligand that was developed because of its relative insensitivity to the rs6971 polymorphism. Increased TSPO signal on PET is associated with activation of microglia in the brain. The radioligand will be administered in tracer doses at activity of up to 20 mCi (740 MBq), IV, total of one injection. A single dose of radioligand will be injected over 1 minute.
15752259|NCT04840966|Diagnostic Test|Flavor test|A simplified self-administrable flavor test has been proposted to all the enrolled subjects
15752260|NCT04840966|Other|Self-assesment questionnaire|"Questionnaire to score subjective chemosensory function (smell and flavor) before and after COVID-19 using a 0-10 scale with 0 corresponding to no smell/flavor perception and 10 corresponding to excellent smell/flavor perception."
15752261|NCT04840953|Device|Vçac|VAC THERAPY vs SURGICAL DREINAGE
15752262|NCT04840927|Drug|E7386|Regimen A: 40 milligram (mg) IR Oral Tablet.
15752265|NCT04840901|Drug|Lebrikizumab|Administered SC.
15752266|NCT04840888|Drug|LY3484356|Administered orally.
15752267|NCT04840888|Drug|Omeprazole|Administered orally.
15752268|NCT04840888|Drug|Itraconazole|Administered orally.
15752269|NCT04840888|Drug|Rifampicin|Administered orally.
15752270|NCT04840875|Biological|chimeric antigen receptor T cell treatment|Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: about 3 days before cells transfusion, the patients who planned to reinfuse CAR T cells were treated with fluorodarabine 30 mg/m2( body surface area) and cyclophosphamide 250 mg/m2( body surface area) for 3 days. Then this study will be using a 3+3 dose escalation approach from dose 1 (DL-1): 5×105 (±20%) to dose 2 (dl-2): 1×106 (±20%). Below the lowest dose was reinfused at the PI's discretion.
15752378|NCT04839991|Drug|CB307|Tri-specific Humabody targeting CD137, prostate specific membrane antigen and human serum albumin
15752271|NCT04840862|Drug|Trikafta [orange tablet containing ELX 100mg, TEZ 50mg, and IVA 75mg]|Subjects will receive a single dose of trikafta (orange tablet) on day 1 of period 1 and on day 15 of period 2.
15752272|NCT04840862|Drug|Rifabutin 300mg|After washout period greater or equal to 2 days, subjects will receive 300 mg/d of rifabutin on days 1 through 17 of period 2.
15752273|NCT04840849|Biological|nirsevimab|Drug: injection, a single fixed IM dose on day 1 only.
15752274|NCT04840849|Other|Placebo|Placebo: injection, 0.9% (w/v) saline, a single fixed IM dose on day 1 only.
15752275|NCT04840836|Behavioral|Telehealth-supported LARC provision|"Provision of LARC in routine care will include a hybrid model of telehealth-supported long-acting reversible contraception (LARC) service provision in a network of 6 school-based health centers (SBHCs) in New York City that serve adolescents and young adult high school students age 13-22 years (hereafter referred to as adolescents)."
15752276|NCT04840823|Drug|Enoxacin|Oral 200mg tablet
15752277|NCT04840823|Drug|Placebo|Oral tablet
15752278|NCT04840810|Procedure|In-plane Axis|"In a long-axis view, the image plane is parallel to the course of the vessel (needle is in-plane). The image shows the course of the vessel across the screen and the shaft and point of the needle as it is advanced. The central venous cannulation was done in in-plane axis."
15752279|NCT04840810|Procedure|Out of plane Axis|"In a short-axis view, the image plane is perpendicular to the course of the vessel and to the needle (needle is out of plane). The vessel appears as an anechoic circle on the screen of ultrasound with the needle visualized as a hyperechoic point in cross-section. The central venous cannulation was done in out of plane axis."
15752280|NCT04840797|Device|HeartStart HS1|Automated External Defibrillator
15752281|NCT04840784|Drug|ETH-155008|"ETH-155008 is an orally bioavailable, potent Pim-3 and CDK4/6 dual kinase inhibitor.
~Dosage form:10mg, 20 mg and 40 mg, tablets. ETH-155008 tablets should be taken while fasting, either 1 hour before or 2 hours after a meal."
15752282|NCT04840771|Procedure|Endoscopic Endonasal Pituitary Surgery|Surgical treatment consisted of an endoscopic endonasal approach using a rigid 0-degree endoscope, 18 cm in length and 4 mm in diameter.
15752283|NCT04840758|Radiation|Stereotactic Ablation Radiotherapy|Stereotactic ablation radiotherapy was performed sequentially on the primary and secondary lesions. 50Gy/4F or 70Gy/10F were used according to the specific location of the tumor。
15752284|NCT04840758|Drug|Sintilimab|Sintilimab was started 2 weeks after the end of radiotherapy. Sintilimab : 200 mg intravenously, Q3W every cycle , given on the D1 of each cycle, and total of 4 cycles
15752285|NCT04840745|Drug|CKD-841 A-1 3.75mg|Single injection, subcutaneous injection
15752286|NCT04840745|Drug|CKD-841 A-1 1.88mg|Single injection, subcutaneous injection
15752287|NCT04840745|Drug|CKD-841 D 2.92mg|Single injection, subcutaneous injection
15752288|NCT04840745|Drug|Leuplin Inj. 3.75 mg|Single injection, subcutaneous injection
15752289|NCT04840732|Behavioral|VR training program|Use VR software to make a training education program.
15752290|NCT04840732|Behavioral|usual care|Chemotherapy training as usual care (for training chemotherapy skill).
15752291|NCT04840719|Device|RECO|
15752292|NCT04840706|Device|HFNC Airvo|HFNC device (Airvo) long-term use in in stabile hypercapnic COPD patients, who are non-compliant to NIV after an acute exacerbation of COPD
15752293|NCT04840706|Other|Standard care|No HFNC treatment
15752294|NCT04840693|Biological|Biological samples|blood, urine, saliva
15752295|NCT04840693|Other|Complications|bone mineral density, diabetes, hypertension, quality of life (quality of life questionnaire SF-36)
15752296|NCT04840680|Other|No Intervention|This is a non-interventional study.
15752297|NCT04840667|Drug|REPLAGAL|Participants will receive REPLAGAL 0.2 mg/kg body weight of IV infusion for 104 weeks.
15752298|NCT04840654|Procedure|Caudal Block|"A caudal block is a procedure that will help lessen a child's pain after an operation.
~100 subjects will be randomized to this block procedure."
15752299|NCT04840654|Procedure|Pudendal Block|"form of local anesthesia commonly used in the practice of obstetrics to relieve pain during the delivery of baby by forceps.
~100 Subjects will be randomized to this block procedure."
15752300|NCT04840641|Drug|Flucloxacillin|Healthy volunteers will take 2x500 mg flucloxacillin 3 times a day for 31 days. The investigators will measure the baseline concentration of the 6-cocktaildrugs and flucloxacillin before start of 31 days of flucloxacillin treatment. On day 9 and 27 the investigators will measure the concentration of flucloxacillin. On day 10 and 28 the investigators will measure the concentration of the 6 cocktaildrugs
15752301|NCT04840628|Other|Resistance of the respiratory system|increase the resistance of the respiratory system of the chronic obstructive pulmonary disease patients
15752302|NCT04840615|Biological|LMB-100|administered into lesion on days 1 and 4 of up to two 21 day cycles
15752303|NCT04840615|Drug|ipilimumab|administered intravenously once per cycle in up to four 21 day cycles. Administration will occur in combination with LMB-100 in the first two cycles.
15752310|NCT04840576|Other|Regular waterproof sterile dressing.|Waterproof sterile dressing OPSITE Post-Op Visible, Smith & Nephew, UK
15752311|NCT04840576|Other|Prophylactic Negative Pressure Dressing|Negative wound pressure dressing: PICO-7, Smith & Nephew, UK
15752312|NCT04840563|Device|Kalifon A|Commercially available kalifilcon A lenses
15752313|NCT04840563|Device|Dailies Total1|Dailies Total1
15752314|NCT04840563|Device|Precision1|Precision1
15752315|NCT04840550|Drug|Lansoprazole 15 mg|Lansoprazole 15 mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months.
15752316|NCT04840550|Drug|Tegoprazan 25 mg|Tegoprazan 25 mg tablets will be orally administered once a day, with NSAIDs, for up to 6 months.
15752317|NCT04840537|Procedure|endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure of ERCP|endoscopic retrograde cholangiopancreatography with cholangioscopy in the first procedure for exploration of an indeterminate biliary stenosis and biliary drainage
15752318|NCT04840524|Procedure|Laminate veneers preparation|facial laminate veneers teeth preparation
15752319|NCT04840511|Drug|lidocaine group|lidocaine 1.5 mg/kg bolus (infused over 10 min) followed by 2.0 mg/kg/h during operation and 1.0 mg/kg/h during postoperative 24 hours (no more than 120 mg/h)
15752320|NCT04840511|Drug|control group|normal saline 0.15 ml bolus followed by 0.15 ml/kg/hr during operation and 0.2 ml/kg/hr during postoperative 24 hours
15752321|NCT04840498|Behavioral|Autism Research|Measuring aspects such as self esteem, social skills, and social anxieties.
15752322|NCT04840485|Drug|SHR-1314|SHR-1314 high dose
15752323|NCT04840485|Drug|SHR-1314|SHR-1314 low-dose
15752324|NCT04840485|Drug|Placebo|Placebo
15752327|NCT04840459|Biological|BAMLANIVIMAB|n. Bamlanivimab is a recombinant neutralizing human mIgG1? monoclonal antibody (mAb) to the spike protein of SARS-CoV-2, and is unmodified in the Fc region.
15752328|NCT04840459|Biological|CASIRIVIMAB|CASIRIVIMAB is a recombinant human mAbs which are unmodified in the Fc regions.
15752329|NCT04840459|Biological|IMDEVIMAB|IMDEVIMAB is a recombinant human mAbs which are unmodified in the Fc regions.
15752330|NCT04840446|Device|Dexcom Continuous Glucose Monitoring System|Dexcom Sensor
15752331|NCT04840433|Device|MACE|Using magnetically assisted capsule endoscopy to examine oesophagus and stomach
15752332|NCT04840420|Other|social prescribing|as above
15752333|NCT04840420|Other|usual care|as above
15752334|NCT04840407|Behavioral|SHARP coach intervention|The Coach provides guidance and support through four 45-60 minute in-home visits: Visit 1: to facilitate effective team communication, this visit is conducted, when possible, with the rehabilitation therapist, the patient/family, the direct care aide and the Coach, who jointly reviews the rehabilitation plan of care. Visits 2-4 include: discussion/observation of HHA/patient exercise repetition sessions, along with: 1) discussing falls prevention, signs of a recurrent stroke and when to call 911; 2) modeling motivation techniques, assessing adherence barriers and revising strategies for addressing them; and 3) identifying/ reporting signs of anxiety/depression. Additional coaching visits and calls may be scheduled as needed depending on the aide's progress in addressing barriers and the patient's progress toward rehabilitation goals.
15752335|NCT04840394|Drug|BDB018|BDB018 is an immunotherapy agent.
15752336|NCT04840394|Drug|Pembrolizumab|Pembrolizumab is a potent humanized monoclonal antibody with high specificity of binding to the PD 1 receptor. Pembrolizumab has an acceptable preclinical safety profile and is approved as an IV therapy for a variety of advanced malignancies.
15752337|NCT04840381|Behavioral|Questionnaire administrations|Administration of an ad hoc questionnaire to register food frequency consumption and meal time, main recipes; phisical activity questionnaire and list of questions concerning the previous and actual health status of participants
15752338|NCT04840368|Other|Dancing|Participants randomized to the dance group will take part in a dance intervention programme for 12 weeks, including 3 sessions per week (non-consecutive days), each lasting 60 min. Dance classes will be performed individually at home, guided by an expertise instructor, as live sessions online. They will include a variety of rhythms such as salsa, merengue, jazz dance, aerobics, etc. The dance sessions will include a warm up of approximately 10 min (posture, join mobility and dance technique), a main part of 40 min (practicing isolated dance moves and learning of specific choreographic routines), and a cool down of 10 min (muscle stretching and relaxation).
15752339|NCT04840355|Drug|Sintilimab Injection|The recommended dose for intravenous infusion is 200 mg on day 1.Courses repeat every 21 days for up to 6 months in the absence of disease progression or unacceptable toxicity.
15752340|NCT04840342|Drug|Eplerenone|Dose escalations of eplerenone 50, 100, or 200mg
15752341|NCT04840342|Drug|Amlodipine|Dose escalations of amlodipine 2.5, 5, or 10mg
15752342|NCT04840329|Behavioral|Education|One-time educational session about menstrual health and endometriosis
15752343|NCT04840303|Behavioral|LevelMind@JC Mental Wellness Youth Hubs|Mental Wellness Youth Hubs Intervention aims to set up a series of community-based hubs for young people to enhance cognitive abilities, personal strengths and overall mental well-being. Among the experimental group participants (hub users), they are further divided into three tiers according to their psychological distress level. Tier 1 are youths with mild psychological distress level, who will be invited to participate in some innovative and interesting youth projects and activities (e.g., board game and floral artistry). Tier 2 are youths who have moderate level of psychological distress, or at risk for mental illness. Trained social workers will offer them with specific interventions (e.g., CBT, sleep intervention) according to their needs. Tier 3 are youths with severe level of psychological distress who are at risk for mental disorders. Diagnostic and medical assessment services will be delivered by psychiatrist or clinical psychologists.
15752344|NCT04840290|Drug|Biological: Sintilimab Drug: Cisplatin Drug: Paclitaxel for Injection (Albumin Bound) Drug: Carboplatin|Biological: Sintilimab Drug: Cisplatin Drug: Paclitaxel for Injection (Albumin Bound) Drug: Carboplatin
15752345|NCT04840277|Device|Remote hearing aid adjustment|The intervention group is offered remote hearing aid adjustment whilst the control group is offered traditional hearing aid adjustment the requires physical appointments at the clinic. Remote hearing aid adjustment is applicable through mobile applications that hearing aid users download to their mobile phones.
15752346|NCT04840264|Drug|Docetaxel|25 mg/m, D1, D8, D15, repeat every 4 weeks.
15752347|NCT04840264|Drug|Oxaliplatin|85 mg/m, , D1, D15, repeat every 4 weeks.
15752348|NCT04840264|Drug|5Fluorouracil|1200 mg/m, D1, D8, D15, repeat every 4 weeks.
15752349|NCT04840251|Other|Well-being review and rehabiliation|"For their well-being review, patients will meet with a physiotherapist specialist in PH and discuss:
~how they are
~what they can do for themselves
~what it is challenging for them to do
~how active they are
~if they have ever exercised before The physiotherapist will then make a referral to the most suitable rehabilitation service local to the patient e.g. rehabilitation classes, physiotherapy at home, weight-loss programmes."
15752350|NCT04840251|Other|Qualitative Interviews|Patients who have previously undergone rehabilitation will take part in a semi-structured interview to explore their experience and the impact it has had
15752351|NCT04840238|Drug|Cholecalciferol|30,000IU cholecalciferol
15752352|NCT04840238|Drug|Placebo|Placebo tablets
15752443|NCT04839445|Procedure|General anesthesia + ESP block|Pre induction ESP block for intra and postoperative analgesia.
15752353|NCT04840225|Other|Measurement of biomarkers for inflammation and anemia|Measurement of biomarkers for inflammation and anemia, in addition to standart clinical measurements
15752354|NCT04840212|Other|Lavender-Sandalwood scented aromatherapy sticker|The Lavender-Sandalwood scented aromatherapy sticker will be placed on the patient gown.
15752355|NCT04840199|Drug|Letermovir|240 mg tablets. Administered orally.
15752356|NCT04840199|Drug|Placebo|Composed of lactose monohydrate, cellulose and magnesium stearare. Administered orally.
15752357|NCT04840199|Drug|Combination ART|ART (antiretroviral therapy) medications will be prescribed by participants' health care providers. ARV medications will not be provided by the study.
15752358|NCT04840186|Procedure|Liver-resection or ablation|Liver-resection of colorectal liver metastasis. Ablation can be used as adjunct to surgery.
15752359|NCT04840186|Drug|2nd line chemotherapy|2nd line chemotherapy. Type of chemotherapy is determined by treating oncologist
15752360|NCT04840173|Behavioral|Music|During attendance at a one hour, 6-week psychosocial classroom or virtual training, caregivers will learn to use singing and other music-based interventions, implementing them each week before the informational session.
15752361|NCT04840160|Dietary Supplement|Cherry juice|A tart cherry juice intervention
15752362|NCT04840160|Dietary Supplement|Placebo|A tart cherry juice placebo
15752365|NCT04840134|Behavioral|From Hardship to Hope: A Peer-led intervention to reduce financial hardship and suicide risk|"The intervention will be delivered in two consecutive phases of 12 weeks each:
~Intensive Intervention Phase, including 12 weekly peer-led group sessions (90min) and four one-on-one coaching sessions (60min); and
~Follow-up Intervention Phase consisting of bi- weekly phone check-ins to provide ongoing support (15-20min).
~Key intervention components:
~Peer-led group sessions include personal stories of financial empowerment; practical information about available financial supports (e.g., free financial counseling services); basic financial coaching and mutual support/ accountability (e.g., goal/action check-ins);
~One-on-one peer coaching sessions (throughout 24 weeks) to help participants identify their personal financial stressors and facilitate a personalized Financial Wellness Action Plan.
~Support to navigate and access financial supports in the community (e.g., financial counseling, free tax prep, housing eviction prevention, debt relief)."
15752366|NCT04840121|Diagnostic Test|AdhesioRT|AdhesioRT, a novel diagnostic genetic assay, developed by ovo R&D scientists, helps to predict the endometrial receptivity and embryo implantation.
15752367|NCT04840108|Behavioral|Support Person Coaching Intervention|The intervention condition will include, for the SPs, a manualized, 1-session coaching intervention delivered by a research coach. The call will be delivered by phone using VA-permitted remote audio or video communication technology (e.g., doximity dialer, Zoom, or VA Video Connect if a Veteran). Coaches will use behavior change strategies delivered with a MI style.
15752368|NCT04840108|Behavioral|Support Person Written Materials|Support persons will receive existing written materials on effective social support strategies for smoking cessation. Materials will be sent via postal mail.
15752369|NCT04840095|Drug|Ketones|Sports supplement that is administered mid-scan.
15752370|NCT04840095|Drug|Glucose|Supplement is administered mid-scan.
15752371|NCT04840082|Diagnostic Test|Nasopharyngeal swab for COVID-19 testing|A nasopharyngeal swab was performed endoscopically video guided to measure the actual length from to the mid turbinate and the posterior nasopharyngeal wall
15752372|NCT04840069|Drug|Fluciclovine PET guided Radiotherapy|PET+MRI Based There is no GTV_5400. The GTV_6000 will be defined as the surgical cavity inclusive of any remaining tumor enhancement and the hypermetabolic volume. CTV_5400 will include the GTV_6000 plus a margin of 1.0 cm which may be reduced around natural barriers to tumor growth such as the skull, ventricles, falx, etc. CTV_5400 must also include the entirety of the GTV_6000. There is no CTV_6000. PTV_5400 is the CTV_5400 plus a geometric 3 mm expansion in all dimensions; PTV_6000 is GTV_6000 plus a geometric 3 mm expansion in all dimensions. PTV may extend beyond bony margins and the skin surface. The PTV_5400 must contain the PTV_6000. In the setting of multi-focal disease, the primary target volumes will be defined as above, but for satellite lesions, the GTV_6000 will be defined as any tumor enhancement and hypermetabolic volume. There will be no CTV_6000. PTV_6000 will be defined as GTV_6000 plus a geometric 3 mm expansion in all dimensions.
15752373|NCT04840043|Other|Osteopathic sympathic harmonization|Treatments that harmonize at the sympathetic nerves or plexus, e.g., sympathetic trunk stimulation by means of the rib-raise technique or stimulation of the prevertebral ganglia.
15752374|NCT04840043|Other|Sham intervention|Different location, size and time of the rib-raise technique or stimulation of the prevertebral ganglia.
15752375|NCT04840030|Behavioral|Multimodal intervention (MM-int)|"Cognitive intervention objective: To enhance cognitive functioning and incorporate daily habits and routines that are cognitively stimulating
~Socio-emotional intervention objective: • Promote socio-emotional skills associated with awareness, communication and regulation of emotions in late life.
~Nutritional intervention objective: To improve eating habits of participants to be based on the Mediterranean Dietary pattern by an educational program
~Physical activity intervention objective: To improve aerobic capacity y, decrease the risk of falls, and improve static and dynamic balance.
~Risk factors and comorbidities monitoring intervention: quarterly scheduled visits for a cardiovascular risk factors check-up and review active medication"
15752376|NCT04840017|Other|rehabilitation exercise|Rehabilitation exercise of intrinsic foot muscles
15752377|NCT04840004|Drug|Aprepitant|Since there is no specific dose range is available for testing the anti-tumor effects of aprepitant in clinical trials settings, in the present study the dose of aprepitant will be up-titrated 250/160/160 mg to maximum 1000/640/640 mg as described in study methodology section.
15752379|NCT04839978|Behavioral|Connect Program|The Connect program includes school-based screening, brief intervention and referral, and will be treated as part of the participating schools' prevention programs. Cherokee Nation Behavioral Health (CNBH) supervised Connect coaches will provide screening and brief intervention universally, to reduce potential stigma associated with speaking to a Connect coach and to reinforce drugfree norms among all students.
15752380|NCT04839978|Behavioral|Communities Mobilizing for Change and Action (CMCA)|The community-level intervention Communities Mobilizing for Change and Action (CMCA) will involve organizing of adult volunteers and consent will be assumed by their participation. We will provide trainings and tools to support local community organizers and their citizen Action Teams, including information on national and local opioid and other drug use, evidence-based policies and programs, and how to motivate and create local action for drug prevention.
15752381|NCT04839965|Biological|Ampion|Ampion administered via intravenous infusion
15752382|NCT04839965|Other|Saline|Placebo administered via intravenous infusion
15752383|NCT04839952|Behavioral|Healthy Lifestyles|12 telehealth sessions. The first 5 visits include psycho/medical education plus a motivational interviewing component. The second 7 sessions include psycho/medical education plus a problem solving training component.
15752384|NCT04839952|Behavioral|Education-Only Control|This control condition includes meeting with a clinician for one telehealth visit to review nutrition and physical activity recommendations.
15752385|NCT04839939|Other|Conventional physical therapy|Stretching for tight muscles, weak muscles Strengthening, Postural reactions training, Proprioceptive training, and Walking training
15752386|NCT04839939|Other|Ankle Foot Orthosis|Solid prescribed AFO with a wearing schedule of 6-12 hours per day
15752387|NCT04839939|Other|Combination Taping|Combination between elastic and inelastic taping
15752388|NCT04839926|Drug|0.5mg CY150112|single oral CY150112 while fasting on day 1.
15752389|NCT04839926|Drug|1.5mg CY150112|single oral CY150112 while fasting on day 1.
15752390|NCT04839926|Drug|4.5mg CY150112|single oral CY150112 while fasting on day 1.
15752391|NCT04839926|Drug|10mg CY150112|single oral CY150112 while fasting on day 1.
15752392|NCT04839926|Drug|18mg CY150112|single oral CY150112 while fasting on day 1.
15752393|NCT04839926|Drug|24mg CY150112|single oral CY150112 while fasting on day 1.
15752394|NCT04839913|Diagnostic Test|Antibodies testing|Serologic test for both SARS-COV-2 IgG and IgM
15752395|NCT04839900|Other|Proactive iCCM|CHWs in the proactive iCCM intervention arm will conduct weekly visits of all households in their communities to detect children < 5 years with diarrhea or cough, and people of all ages complaining of fever or history of fever. People with fever or history of fever in the past 48 hours, or any person with symptoms suggestive of malaria (chills, headache, muscle ache, fatigue, etc), will receive an RDT; those with positive results will be defined as confirmed malaria cases, and will receive the first line antimalarial. Any child under 5 years with diarrhea will be treated with oral rehydration solution (ORS) and zinc, and any child meeting diagnostic criteria for pneumonia will receive the first line antibiotic recommended per national iCCM policy. If the CHW does not have the indicated therapy on hand, the patient will be referred for treatment.
15752396|NCT04839874|Other|No intervention|Semi-structured qualitative interviews
15752399|NCT04839848|Device|Lichtenstein mesh repair|A groin hernia repair, reinforced by synthetic mesh. The mesh is affixed with sutures
15752400|NCT04839835|Other|waiting room enriched with music, paintings and artificial plants|waiting room enriched with music, paintings and artificial plants
15752401|NCT04839822|Other|edupression.com®|"Edupression.com® is an evidence-based self-help program that was developed for the treatment of mild to moderate unipolar depression. It is based on two core foundations, psychoeducation with elements of cognitive behavior therapy (CBT) and a mood chart. Both foundations are registered as a medical product. As such, detailed risk management documentation includes probability and severity of adverse events. Moreover, detailed strategies such as warnings were implemented in the software and documented accordingly.
~It can be used on a PC as well as on mobile devices (browser, App) at any time."
15752402|NCT04839822|Other|Health tips|Interventions that do not directly target depression: general health tips (diet, lifestyle, smoking, etc.), occupational health interventions (back pain prevention, breaks,...), etc.
15752403|NCT04839822|Diagnostic Test|Surveys|Quizzes and surveys for course monitoring (including suicidality), but without extensive reports.
15752404|NCT04839822|Other|Popular psychological interventions|Popular psychological interventions, which have not been shown to be effective in studies: Affirmation phrases, motivational sayings and quotes (known also from calendars), tests (e.g., Rorschach interpretation), exercises (emotion recognition of faces), multimedia content (pleasant music, landscape images, interviews of famous people with depression), etc.
15752405|NCT04839809|Drug|CC-92480|Oral
15752406|NCT04839809|Other|Placebo|Oral
15752444|NCT04839432|Behavioral|implementation of albumin solution in the priming of the cardiopulmonary bypass machine|In March 2019, the investigators initiated a new priming fluid policy strategy aiming at replacing our traditional pure crystalloid fluid administration for an albumin one in order to decrease the relatively high-rate of observed pulmonary complications
15752445|NCT04839406|Behavioral|Structured support of caregivers at the ICU|Structured support of caregivers at the ICU provided by a trained group of 10-15 ICU nurses
15752407|NCT04839770|Device|Axonpen system|"The Axonpen™ system, containing the Axonpen and the Axonmonitor, has been cleared for the illumination and visualization of intracranial tissue and fluids and the controlled aspiration of tissue and/or fluid during surgery of the ventricular system or cerebrum.
~The Axonpen is a neuroendoscope integrated with suction (sourced from hospital vacuum) and irrigation (sourced from third-party saline infusion bag) functions. The Axonmonitor is used for view and storage of the endoscopic image. The Axonpen™ system is intended to optimize the procedure of minimally invasive neurosurgery for early ICH evacuation."
15752408|NCT04839744|Drug|TG103 produced by the modified manufacturing process|Drug: TG103 (a modified manufacturing process), 15mg, SC
15752409|NCT04839744|Drug|TG103 produced by the original manufacturing process|Drug: TG103 (the original manufacturing process), 15mg, SC
15752410|NCT04839731|Drug|Combination topical 5-fluorouracil 5% / calcipotriene 0.005% cream|Apply twice per day for allotted time
15752411|NCT04839731|Drug|Nourivan Base Cream|Apply twice per day for allotted time
15752412|NCT04839718|Behavioral|ADAPT|The Achieving Depression and Anxiety Patient Centered Treatment (ADAPT) Program is a novel collaborative psychiatric care model that is designed to unburden PCPs and psychiatrists, increase access to quality specialty mental healthcare for Kaiser Permanente members, and improve patient depression and anxiety treatment outcomes by utilizing technology-driven appointments. This program uses principles of collaborative care, including patient-centered care, population-based care, evidence-based care, measurement-based treatment to target, and accountable care.
15752413|NCT04839705|Device|WEB|"Device: WEB The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.
~Other Names:
~• WEB Aneurysm Embolization Device"
15752414|NCT04839692|Drug|Hyaluronic acid filler|Hyaluronic acid filler treatment of the lips with Restylane Kysse, which is a FDA approved treatment for lip augmentation.
15752415|NCT04839679|Behavioral|Culturally Oriented Educational Brochure|Culturally appropriate educational brochure summarizing pertinent treatment information in a visual manner
15752416|NCT04839679|Behavioral|Mayo Clinic Educational Booklet|"An Introduction to Radiation Simulation and Treatment- Barbara Woodward Lips, Patient Education Center"
15752417|NCT04839666|Drug|Propofol|Perioperatively propofol administration
15752418|NCT04839653|Drug|Oral Paste(0,5 g) containing 10 mg of polymyxin B, 10 mg of gentamycin and 150 mg of amphotericine B or 500 000 U of nistatin q6h|The oral paste will be applied topically on the oropharyngeal mucosa q6h.
15752419|NCT04839653|Drug|Suspension (10 ml) containing 100 mg of polymyxin B, 80 mg of gentamycin, 350 mg of amphotericine B or 8000000 U of nistation and 500 mg of vancomycin q6h|The suspension will be administered through the nasogastric tube q6h.
15752420|NCT04839653|Drug|Intravenous Antibacterial Agent - a 3-day course of systemic cefotaxime 1 g q6h or ceftriaxone 1 g qd|Patients who do not receive systemic antibiotics for other reasons will get a short course of systemic antibiotic
15752421|NCT04839640|Other|Bredent denture teeth|composite resin denture teeth
15752422|NCT04839627|Other|serum progesterone measurement|progesterone levels measurement on the day of the embryo transfer on all AMP cycles
15752423|NCT04839614|Other|CONCURRENT LAPAROSCOPIC HYSTERECTOMY AND WEIGHT LOSS SURGERY-Referral|See arm description
15752424|NCT04839601|Device|RNS System|The RNS System provides closed loop responsive brain stimulation. The Neurostimulator monitors the electrical activity of the brain to detect abnormal activity that could lead to a seizure. If abnormal activity is detected, the neurostimulator delivers electrical stimulation to the brain through the leads to help prevent the seizure before it occurs.
15752425|NCT04839588|Other|Usability study|"Participants will first be screened for propensity to simulation sickness and for cognitive state using the MoCA evaluation test. Those who passed the screening will perform 4 usability sessions rating the ease of use and perceived benefit of the experimental system and of a caregiver interface laptop. The 2 healthy volunteers will evaluate first, such that issues may be resolved before testing is done on the impaired participants. Each session will be compensated with a $35 payment. During each session participants will play a series of increasing difficulty simulated tasks, aimed to train primarily the executive functions domain. At the end of each session participants will rate their experience using custom subjective evaluation forms with multiple items. Each item will be scored using a 5-point Likert scale. At the end of the 4th session, participants will also fill the USE standardized usability form.
~This usability evaluation will be conducted at the NJ Bioscience Center."
15752426|NCT04839575|Drug|Latiglutenase|Administered orally (daily)
15752427|NCT04839575|Drug|Placebo|Administered orally (daily)
15752428|NCT04839562|Drug|Solriamfetol 75 MG|Daily oral consumption
15752429|NCT04839562|Drug|Solriamfetol 150 MG|Daily oral consumption
15752430|NCT04839562|Other|Placebo|Placebo
15752431|NCT04839549|Drug|Dextenza 0.4Mg Ophthalmic Insert|Dextenza 0.4Mg Ophthalmic Insert
15752432|NCT04839549|Drug|Fluoromethalone .01%|Fluoromethalone .01%
15752433|NCT04839536|Drug|Sevoflurane inhalant product|Sevoflurane will be delivered in an incremental dose to throughout procedure to achieve clinical sedation endpoint OAAS 3.
15752434|NCT04839523|Device|Exufiber|A sterile nonwoven wound dressing made from highly absorbent PVA fibers.
15752435|NCT04839523|Device|Exufiber Ag+|A sterile nonwoven wound dressing made from highly absorbent PVA fibers, and coated with silver sulphate.
15752436|NCT04839510|Drug|MRG002|Administrated intravenously
15752437|NCT04839497|Combination Product|Autologous Volar Fibroblast Injection into the Terminal Limb of Amputees|Autologous Volar Fibroblasts Treatment- harvested from patient's biopsied volar skin. Intradermal injection of Volar fibroblasts in the affected area of the residual limb of transtibial amputees to treat skin problems.
15752438|NCT04839484|Device|Study Product|up to 2cc per injection of filler placed into nasolabial fold.
15752439|NCT04839484|Device|Active Control|up to 2cc per injection of filler placed into nasolabial fold.
15752440|NCT04839471|Drug|BI-754091 plus afatinib|Eligible patients will receive BI-754091 240 mg on D1, afatinib 30 mg/day on day 1 to 21 in a 3-week cycle.
15752441|NCT04839458|Device|Dental Prescale II|"The participant will bite Dental Prescale II for about 3 seconds, using a force for  chewing beef . And the Dental Prescale II will be taken out from the mouth. Then the trial is end."
15752442|NCT04839445|Procedure|General anesthesia + TAP block|Post induction TAP block for intra and postoperative analgesia.
15793435|NCT04504929|Device|Sham tape|Use sham type on the pitching shoulder
15752446|NCT04839393|Drug|PF-06882961 followed by PF-06882961/PF-06865571|Treatment A - PF-06882961 20 mg single dose followed by Treatment B - PF-06882961 20 mg single dose plus PF-06865571 300 mg single dose. There will be a washout interval between periods of at least 3 days.
15752447|NCT04839393|Drug|PF-06882961/PF-06865571 followed by PF-06882961|Treatment B - PF-06882961 20 mg single dose plus PF-06865571 300 mg single dose followed by Treatment A - PF-06882961 20 mg single dose. There will be a washout interval between periods of at least 3 days.
15752448|NCT04839393|Drug|PF-06882961 + PF-06865571|Period 1: PF-06865571 300 mg single dose (Day 1), Period 2: PF-06882961 10 mg twice daily dose titration up to 200 mg twice daily dosing (Days 3-46), Period 3: PF-06865571 300 mg single dose (Day 47) and PF-06882961 200 mg twice daily dosing (Days 47-48), Period 4: PF-06865571 300 mg twice daily dosing and PF-06882961 200 mg twice daily dosing (Days 49-62)
15752449|NCT04839380|Drug|ruxolitinib cream|ruxolitinib cream 1.5% will be applied twice daily as a thin film
15752450|NCT04839367|Drug|64Cu-SAR-bisPSMA|64Cu-SAR-bisPSMA
15752453|NCT04839341|Drug|Uproleselan|A rationally designed E-selectin antagonist used to inhibit binding of cells to E-selectin
15752454|NCT04839328|Drug|60mg Hemay005|Hemay005 is a small molecule PDE4 inhibitor.
15752455|NCT04839328|Drug|Placebo|Placebos are the same as drugs, but contain no Hemay005.
15752456|NCT04839315|Biological|mRNA COVD19 vaccine|Subjects will receive two doses of mRNA based COVID19 vaccines.
15752457|NCT04839302|Drug|Indocyanine green solution|Patients with clinical suspicion of necrotizing fasciitis would receive a weight-appropriate IV dose of indocyanine green (ICG, FDA-approved) with immediate fluorescence imaging of the affected body part and simultaneous imaging of an unaffected region
15752458|NCT04839289|Device|Receiver-in-canal hearing instrument; Manufacturer A|Commercially available receiver-in-canal hearing instrument from manufacturer A
15752459|NCT04839289|Device|Receiver-in-canal hearing instrument; Manufacturer B|Commercially available receiver-in-canal hearing instrument from manufacturer B
15752460|NCT04839276|Combination Product|Injection Laryngoplasty with Platelet-rich Fibrin and Autologous Fat|Injection Laryngoplasty with a combination of Platelet-rich Fibrin (PRF) and Autologous Fat. The PRF was made by taking 10 mL of peripheral blood from a healthy donor. Blood is then put inside the tube from the Regen lab kit. The tube was centrifuged with a force of 1,500 g (3000 rpm) for 5 minutes producing platelet-rich plasma (PRP). 4 mL of the aforementioned PRP was transferred to a 10 mL test tube, 1 M CaCl2 was added with a micropipette until final concentration of 25 mM was, reached producing PRF. Autologous fat harvested from the patient's abdomen was then mixed with the PRF solution to create the filler for injection laryngoplasty procedures. The injection procedures are done by placing the patient in a sniffing position followed by intraoral Kleinsasser laryngoscope insertion through the uvula, posterior pharyngeal wall, and epiglottis until the vocal cords are visible. Injection of the filler is then done to the paralyzed vocal cords.
15752461|NCT04839276|Procedure|Injection Laryngoplasty with Autologous Fat|Injection Laryngoplasty with autologous microlobular fat harvested from the patient's abdominal fat. Lidocaine was infiltrated under the umbilicus and then an incision was made in the area followed by fat removal using scissors. The fat was cleaned with 0.9% NaCl solution and then sheared into microlobular form. The injection procedures are done by placing the patient in a sniffing position followed by intraoral Kleinsasser laryngoscope insertion through the uvula, posterior pharyngeal wall, and epiglottis until the vocal cords are visible. Injection of the filler is then done to the paralyzed vocal cords.
15752462|NCT04839263|Procedure|"FAST TRACK protocol"|"Preoperative evaluation and information
~Patient general health state optimization proposal prior to hospitalization:
~Preoperative strategy:
~Hospitalization on surgery day
~No prolonged fasting
~Perioperative strategy:
~Pain control based on limited systemic opioid therapy use
~Anti-nausea prophylaxis
~Anaesthesia via IV propofol / remifentanyl
~Bladder catheter removal postoperative
~Postoperative strategy:
~Pain control using balanced analgesia
~Gum chewing
~Early oral refeeding and rapid mobilization
~Venflon removal 6 hours post-op"
15752463|NCT04839250|Procedure|heads-up method|3D surgical video system, which includes Alcon NGENUITY 3D visualization system (Alcon, Fort Worth, TX) and Leica M822 and M844 microscopes (Leica Microsystems, Wetzlar, Germany),can be used to perform head-up phacoemulsification combined with intraocular lens implantation surgery.
15752464|NCT04839237|Drug|Liraglutide|The treatment of Liraglutide lasted three months,During the first week: 0.6mg per day, subcutaneous injection;During the second week: 1.2mg per day, subcutaneous injection; From third week onwards,1.8mg per day, subcutaneous injection.
15752465|NCT04839237|Drug|Liraglutide;metformin|The treatment of Liraglutide combined with metformin lasted three months.For Liraglutide,during the first week: 0.6mg per day, subcutaneous injection;during the second week: 1.2mg per day, subcutaneous injection; from third week onwards,1.8mg per day, subcutaneous injection.For metformin,during three months:0.5g each time, 3 times per day,oral.
15752466|NCT04839224|Drug|carbogen|Patients will inhale carbogen gas for 10 minutes and rest for 50 minutes.
15752467|NCT04839224|Drug|phenylephrine|Start phenylephrine with 0.5 mg/hr and titrate upto 3.5 mg/hr or systolic blod pressure 200 mmHg.
15752468|NCT04839211|Device|Inspiratory muscle training|Inspiratory muscle training will be performed three sessions per week as one supervised and two unsupervised for 8 weeks using an inspiratory muscle training device (PowerBreath). The inspiratory muscle training session will consist of 7 cycles including a 2:1 ratio of work and rest interval. Resistance will be adjusted to the highest tolerable load and will be gradually increased.
15752469|NCT04839211|Device|Sham inspiratory muscle training|Sham inspiratory muscle training will be performed three sessions per week as one supervised and two unsupervised for 8 weeks using an inspiratory muscle training device (PowerBreath). The inspiratory muscle training session will consist of 7 cycles including a 2:1 ratio of work and rest interval. Resistance will be adjusted to the unloaded.
15752470|NCT04839198|Behavioral|Android Wear smartwatch|All participants will wear an Android Wear smartwatch, and will complete ecological momentary assessments (EMA).
15752567|NCT04838223|Other|Visual Analogue Questionnaire|Symptoms of ocular comfort and dryness will be graded for each eye on a scale of 0-10, where 0=extremely uncomfortable, extremely dry and 10=excellent comfort, no dryness. An average rating will be provided for the morning, afternoon and evening.
15752471|NCT04839198|Behavioral|Adaptive Treatment|"Participants will have access to a Dashboard button in the InsightTM app that displays personalized statistics based on their progress and patterns in the study.The dashboard will update as more data is collected about the participant's smoking habits, starting in the pre-quit period and continuing through the post-quit period. Second, in the post-quit period, participants will receive treatment messages when the machine learning algorithm determines that they are at high risk for lapse.At the follow-up visit, participants will complete a survey to evaluate what they liked and disliked about the intervention, how accurate they thought the app was in predicting their risk, and how useful they found the dashboard."
15752472|NCT04839198|Drug|Nicotine Patch|At Visit 2, participants will be asked to begin their attempt to quit smoking and will receive a 12-week supply of nicotine replacement therapy (i.e., nicotine patches and gum)
15752473|NCT04839198|Behavioral|interviewing-based counseling|At Visit 2, participants will be asked to begin their attempt to quit smoking and meet with a Tobacco Treatment Specialist, who will provide motivational interviewing-based counseling, help the participants develop a quit plan, and discuss relapse prevention. During the 6-weeks of the study, participants will have the option of attending up to 6 counseling sessions with the Tobacco Treatment Specialist, either in-person or via phone or web.
15752476|NCT04839172|Diagnostic Test|Dual-energy X-ray Absorptiometry (DXA) scan|Longitudinal changes in body composition are examined over four consecutive seasons (2017-2018, 2018-2019, 2019-2020, 2020-2021), four times per season in the following stages: start-preseason, start-season, mid-season and end-season.
15752477|NCT04839159|Other|Blood sampling|Blood sampling at the age of 6 and 12 months, 2-3-4 years
15752478|NCT04839159|Other|Blood sampling|Blood sampling before any new sickle cell disease treatment as determined by a physician according to the standard of care to which the hospital adheres
15752479|NCT04839146|Biological|ABNCoV2 Vaccine|SARS-CoV-2 vaccine
15752480|NCT04839133|Device|MyoSuitFeasibility|Participants will absolve feasibility tests with and without wearing a MyoSuit.
15752481|NCT04839120|Drug|MDPK67b|Two subgroups (Panels A and Panel B) of four subjects were to be randomly allocated either to placebo or to three increasing doses of MDPK67b, administered as single infusion at intervals of at least two weeks during the first three periods with the last period involving four repeated doses administered at three-day intervals.
15752482|NCT04839120|Drug|Placebo|Two subgroups (Panel A and Panel B) of four subjects were to be randomly allocated either to placebo or to three increasing doses of MDPK67b, administered as single infusion at intervals of at least two weeks during the first three periods with the last period involving four repeated doses administered at three-day intervals.
15752483|NCT04839094|Diagnostic Test|rapid antigen testing versus RT-PCR|Sensitivity of rapid antigen testing and RT-PCR performed on nasopharyngeal swabs versus saliva samples in COVID-19 hospitalized patients.
15752484|NCT04839081|Other|questionnaires and inventories|questionnaires and inventories related to primary end secondary outcomes will be applied and physical examination will be performed.
15752485|NCT04839068|Device|covid 19 on pregnancy outcomes|covid 19 on pregnancy outcomes and sex ratio at birth
15752486|NCT04839055|Drug|Coenzyme A Combined With Abiraterone|Abiraterone 4 pieces per day. Coenzyme A 200U
15752487|NCT04839055|Drug|Abiraterone|Abiraterone
15752490|NCT04839029|Procedure|Bipolar En bloc TURBT|patients subjected to Bipolar resection of bladder tumor by Collins loop
15752491|NCT04839029|Procedure|Monopolar En bloc TURBT|patients subjected to Monopolar resection of bladder tumor by Collins loop (hot Knife)
15752492|NCT04839016|Drug|SHR-1314|SHR-1314
15752493|NCT04839016|Drug|Placebo|Placebo
15752496|NCT04838977|Behavioral|RESET|Therapy
15752497|NCT04838964|Drug|MRG003|Administrated intravenously
15752498|NCT04838951|Device|ENDO-AID CADe|ENDO-AID CADe will be used during the withdrawal process of the colonoscopy.
15752499|NCT04838925|Device|Mobile Neurofeedback App|Neurofeedback intervention delivered via mobile app. Participants wear an EEG headset which is connected to a mobile app that delivers feedback about brainwave data indicating whether they are in a calm, relaxed state. Participants hear a lower/simple sound when they are below a target level and higher/richer sound when they approach or achieve their target.
15752500|NCT04838912|Behavioral|Cool Kids (Chilled) Anxiety program adapted to children and youths with anxiety disorders (ASA)|CBT program for anxiety in teenagers with autism
15752501|NCT04838899|Radiation|Stereotactic Body Radiation Therapy (SABR)|SABR to oligoprogressive metastases while continuing abiraterone therapy
15752502|NCT04838886|Other|Telerehabilitation-based Pilates Exercise|The group that will receive telerehabilitation-based pilates training via telerehabilitation
15752503|NCT04838873|Procedure|Open radical cystectomy|Standard open radical cystectomy and urinary diversion
15752504|NCT04838873|Procedure|Laparoscopic-assisted radical cystectomy|Laparoscopic-assisted radical cystectomy and extracorporeal urinary diversion
15752505|NCT04838860|Drug|Siltuximab|Participants will receive intravenous (IV) infusion of siltuximab 22 mg/kg over 2 hours every 3 weeks, then possibly dose escalating to 33 mg/kg IV over 3 hours +/- 44 mg/kg IV over 4 hours every 3 weeks if clinically indicated in the absence of dose-limiting toxicity.
15752506|NCT04838847|Biological|CVnCoV Vaccine|Intramuscular (IM) injection
15752634|NCT04837664|Drug|Curcumin|Curcumin was bought from Sigma®, USA, and its solution was freshly prepared by mixing curcumin powder with phosphate-buffered saline.
15752635|NCT04837664|Drug|Rose Bengal|Rose bengal was bought from Sigma®, USA, and its solution was freshly prepared by mixing rose bengal powder with phosphate-buffered saline.
15752507|NCT04838821|Biological|Anti SARS-CoV-2 equine hyperimmune serum|All participants in the treatment groups will receive a single intravenous infusion on day 1 containing the specified dose according to their assigned group 12mg/kg, 30 mg/kg or 56mg/kg. Total volume of the infusion is 180ml, to be administered during a time period of at least 1 hour. Study participants will be followed during their hospitalization until they are discharged and on Study Day 28.
15752508|NCT04838821|Biological|placebo|All participants in the placebo group will receive a single intravenous infusion on day 1 containing a specified volume of a saline IV solution preparation. Total volume of the infusion is 180ml, to be administered during a time period of at least 1 hour. Study participants will be followed during their hospitalization until they are discharged and on Study Day 28.
15752509|NCT04838808|Drug|Rivaroxaban 2.5 MG [Xarelto]|Rivaroxaban 2.5mg twice daily for 90-days
15752510|NCT04838808|Drug|Placebo|Placebo tablet twice daily for 90-days
15752512|NCT04838782|Procedure|Repeat Surgical Management of Recurrent GBM|Routine of surgical operative management. Details of treatment will be left to local centers, and recorded in the case report form (CRF).
15752515|NCT04838756|Other|AI screening modality|Screen exam will be analysed with an AI system (Transpara, ScreenPoint, Nijmegen, The Netherlands) that assigns exams with a cancer-risk score from 1 to 10, as well as presenting CAD-marks at suspicious findings. Exams with risk score 1-9 will be single read and exam with score 10 will be double read. Risk scores and CAD-marks are provided to the reader(s). The reader(s) will decide whether to recall the woman for work-up or not (as per standard of care). In addition, exams with the highest 1% risk will by default be recalled with the exception of obvious false positives.
15752516|NCT04838756|Other|Conventional screening modality|Screen exams will be read by two radiologists without the support of AI.
15752517|NCT04838743|Drug|IDegLira|"Patients will be treated with commercially available Xultophy® (IDegLira) in a pre-filled pen injector (FlexTouch®) at the discretion of the treating physician in accordance with the Xultophy® label in Japan.
~The decision to initiate treatment with Xultophy® is at the treating physician's discretion according to the approved Xultophy® label in Japan and independent from the decision to include the patient in the study."
15752518|NCT04838730|Device|Surgical procedure|Standard cataract extraction procedure will be performed under local anesthesia (at physician discretion) and CleaRing device will be implanted together with SeeLens AF IOL.
15752519|NCT04838717|Drug|BPG|intramuscular injection of 2.4 million units
15752520|NCT04838717|Drug|Doxycycline|Oral: at a dose of 100 mg bid for 14 days
15752521|NCT04838704|Drug|Ruxolitinib+Calcineurin +Methotrexate|low-dose ruxolitinib combine with calcineurin and short course of methotrexate.
15752522|NCT04838704|Drug|Calcineurin +Methotrexate+Mycophenolate mofetil|calcineurin and short course of methotrexate and mycophenolate mofetil
15752523|NCT04838691|Behavioral|interpersonal counseling|In the intervention group, it will be administered for 40 minutes for 8 weeks to people with symptoms of premenstrual syndrome.
15752524|NCT04838678|Drug|Neuropeptide Y|intra-arterial infusion of neuropeptide Y
15752525|NCT04838665|Drug|0.5% cyclopentolate and 2.5% phenylephrine|Multiple Alternate Instillation of 0.5% cyclopentolate and 2.5% phenylephrine (MAI) dropped every 5 minutes for two doses
15752526|NCT04838665|Drug|0.5% tropicamide + 0.5% phenylephrine|Single instillation of 0.5% tropicamide + 0.5% phenylephrine
15752527|NCT04838665|Drug|0.5% tropicamide + 0.5% phenylephrine with a cotton wick|Single instillation of 0.5% tropicamide + 0.5% phenylephrine with a cotton wick weighing 0.02 milligrams placed in the inferior fornix for the entire 45 minutes
15752528|NCT04838652|Drug|Pembrolizumab plus Chemotherapy (ICE or DHAP)|Pembrolizumab (200mg) alone or in combination with ICE (or DHAP in case of PET positive findings after P-ICE) will be admistered. 6 additional courses of pembrolizumab will be administered after the completion P-ICE or P-DHAP
15752529|NCT04838639|Drug|NO-13065|"Single ascending doses of NO-13065 in separate cohorts of subjects; each cohort consists of 6 subjects treated with NO-13065.
~Single ascending dose of NO-13065 with food effect arm. Multiple ascending doses of NO-13065 for 10 or up to 28 days in separate cohorts of subjects; each cohort consists of 6 subjects treated with NO-13065."
15752530|NCT04838639|Drug|Placebo|Two subjects per cohort will take a matched placebo.
15752534|NCT04838600|Device|ChloraSolv|Debridement with ChloraSolv until the wound is visually assessed as clean.
15752535|NCT04838587|Other|No intervention will be done|No intervention,Only passive surveillance of Diarrhoea cases will be done
15752536|NCT04838574|Other|15 years Follow-up group|Phone recruitment, screening interview and eligibility questionnaire. Patient inclusion during rheumatologic evaluation : questionnaire, examination and data collection in one of the 4 study hospital centers.
15752537|NCT04838548|Drug|MRG003|Administered intravenously
15752538|NCT04838535|Diagnostic Test|Raman spectrum|The wavelength of the follicular fluids were scaned by Raman spectrum
15752539|NCT04838522|Other|No Intervention|This is a non-interventional study.
15752540|NCT04838509|Other|no intervention|retrospective descriptive without intervention
15752568|NCT04838210|Behavioral|EleVATE Group Care|10-session (2 hours per session) group prenatal care model following the prenatal visit schedule recommended by ACOG. In addition to pregnancy and infant-care related content, the EleVATE GC curriculum includes behavioral health strategies that can be used to manage depression and labor pain and navigate the daily frustrations and stress of life. Groups are facilitated by an obstetric clinician.
15752541|NCT04838496|Drug|FOLFOXIRI Protocol|"FOLFOXIRI consists of oxaliplatin, irinotecan, leucovorin and 5-fluorouracil and is administered every 2 weeks:
~Dosing:
~Day 1: irinotecan 165 mg/m2 body-surface area (BSA) intravenously (IV), followed by oxaliplatin 85mg/m2 BSA IV in combination with leucovorin 400mg/m2 BSA, followed by:
~Day 1-2: 3200 mg/m2 BSA of continuous 5-fluorouracil IV
~Day 3-14: rest days.
~Both regimen are initially administered for four cycles. In case of responsive or stable disease, a 5th and 6th cycle of FOLFOXIRI will be administered.
~In case of unacceptable toxicity, the aforementioned dosages can be reduced or one or more chemotherapeutical agents can be omitted at discretion of the medical oncologist and will be noted in the patient's medical file. At discretion of the medical oncologist, a start dosage of 75% of the advised dosage could be considered in patients above 70 years of age."
15752542|NCT04838483|Device|Indirect adhesive restoration of posterior teeth|Indirect restoration of significant loss of dental hard tissue
15752543|NCT04838470|Other|cardiac rehabilitation|multidisciplinary disease management program
15752544|NCT04838457|Behavioral|Alcohol and CVD Management and Engagement through Telehealth and mHealth (ACME-TM)|Participants will obtain 4 sessions of telehealth cognitive behavioral therapy (CBT) focused on reducing alcohol misuse. Participants will receive a 5th telehealth coaching call to develop a plan for ensuing treatment regarding their elevated cardiovascular risk factors. Participants will then receive daily texts for one month aimed at helping them decrease these cardiovascular risk factors.
15752546|NCT04838431|Other|Blood sample and ultrasound at first trimester|The blood sample and the ultrasound are part of the routine care for the aneuploidy screening at first trimester. We deepened the biochemicals and biophysical markers for predicting the risk for large for gestational age infants
15752547|NCT04838405|Drug|CT-388|Synthetic Peptide
15752548|NCT04838405|Drug|Placebo|Placebo
15752549|NCT04838392|Device|RIGHTEST Continuous Glucose Monitoring System|RIGHTEST Continuous Glucose Monitoring System
15752550|NCT04838379|Procedure|Ultrasound guided rectus sheath block|Sixty patients were randomized to receive ultrasound-guided RSB After the induction of anesthesia and patient stabilization, the abdomen was sterilized and draped. Then, under complete aseptic conditions, ultrasound-guided Bilateral Rectus Sheath Block (BRSB) was performed
15752551|NCT04838366|Dietary Supplement|Carbohydrate loading|study group will be intervened with carbohydrate loading as the protocol made by ERAS(Li et al., 2021). Surgical patients will be asked to drink a beverage containing 100 grams carbohydrate the night before surgery. On the day of surgery, patients will drink a beverage containing 50 grams carbohydrate 2 hours before surgery under the supervision of research team member. We will provide glucose-D (Dabur Nepal Private Limited, Bara, Nepal, (Regd No.: 3506/045/046, DFTQC No.: 01-33-55-03-218).
15752552|NCT04838353|Device|ALV1 System|The ALV1 system is designed to create a controlled size interatrial shunt via a proprietary intra-cardiac catheter. There is no temporary or permanent implant used to create or maintain the interatrial shunt. The therapy is intended to be delivered in a single procedure administered under general anesthesia in a cardiac catheterization laboratory.
15752553|NCT04838340|Other|Standart care|This group will leave in the hospital's usual care and no intervention will be applied.
15752554|NCT04838340|Behavioral|Hypnobirthig training|"Hypnobirthing training of the Hypnobirthing group will carry out with its partner. Hypnobirthig training will be given in small groups of 5 or 6 couples for 4 weeks and 3 hours a week. In addition, the usual care will be provided by healthcare professionals to this group.
~Breathing, relaxation exercises, birth stories and birth videos will be used to reduce fears of chlildbirt women.
~Deepening and endorphin massage techniques will be given for labor pain. After the endorphin massage technique will be applied individually by the researcher, it will be applied by the couples and they will ask for repeating all exercises at home.
~In the last week of the training, there will be a birth rehearsal with Hynobirthing methods with the partners.
~The second meeting will take place when labor begins and after labor."
15752555|NCT04838314|Procedure|regional analgesia|Peri operative regional analgesia by bilateral ESP catheter for 72h
15752556|NCT04838301|Drug|Allopregnanolone|Allopregnanolone 4mg IV via 30-minute infusion, once per week.
15752557|NCT04838301|Other|Placebo|Normal saline solution IV via 30-minute infusion, once per week
15752558|NCT04838288|Drug|Change from Prograf to Envarsus XR|Change from Tacrolimus taken twice a day to Envarsus XR taken once a day
15752559|NCT04838275|Behavioral|12-week mHealth home exercise prescription|3x/week home walking protocol, 2x/week resistance exercise program
15752560|NCT04838262|Other|Acute Stressors|Sympathetic nervous system activity and blood pressure will be measured before, during, and after several acute laboratory-based cognitive (Stroop Color Word Test), emotional (International Affective Picture System), and physiological (Cold Pressor Test) stressors.
15752561|NCT04838236|Other|MASP app|mobile intervention that targets anxiety sensitivity among smokers (Mobile Anxiety Sensitivity Program for Smoking: MASP). Our intervention is framed within the cultural context of interoceptive stress among African American smokers, which is supported by theory, empirical evidence, and characteristics of this group.
15752562|NCT04838236|Other|QuitGuide app|the smartphone-based National Cancer Institute (NCI) QuitGuide app for standard mobile smoking cessation treatment
15752563|NCT04838223|Other|Hyperosmolar Response|A single drop of hypertonic sodium chloride solution at room temperature will be instilled in each eye and change in pain/other symptoms after up to 90 seconds of application (to account for any initial irritation symptoms) will be observed.
15752564|NCT04838223|Other|Proparacaine Challenge Test|A single drop of Proparacaine hydrochloride ophthalmic solution, (Alcaine®, 0.5%) will be used on each eye respectively and any change in pain/other symptoms will be noted after 90 seconds (to account for initial discomfort from the preservative in Proparacaine solution).
15752565|NCT04838223|Other|Contact Lens Dry Eye Questionnaire-8 (CLDEQ-8) Optional; only for Contact Lens Wearers|The CLDEQ-8 is a validated eight-item scaled questionnaire developed to reflect the overall opinion of soft contact lenses.
15752566|NCT04838223|Other|Ocular Pain Assessment Survey (OPAS)|Twenty seven-item quantitative questionnaire designed to provide an assessment of the symptoms and quality of life effect of ocular pain [18]. The 27 items of the OPAS questionnaire are graded on a scale of 0 to 10, or 10 to 100, where 0 indicates none and 10 or 100 indicate maximum.
15793746|NCT04502589|Drug|Disulfiram|Disulfiram will be kept at 250mg daily
15752569|NCT04838210|Behavioral|Individual Prenatal Care|The dominant model of prenatal care in the United States, consisting of one-on-one encounters between a patient and obstetric clinician. Patients are seen for 10-15 mins every 4 weeks until 28 weeks gestation, every 2 weeks until 37 weeks or more by provider discretion), and weekly until delivery. Visits focus on routine screening tests and prenatal care.
15752571|NCT04838184|Device|Dental Implants (Straumann Roxolid® / SLActive®)|"In this study the 4 mm implants will be inserted in the area surrounding 36/46. The implant diameters will be defined based on the patient's situation.
~In the interforaminal region, two implants of conventional length with a minimum of 10 mm will be inserted. The implant diameter and the length will be defined based on the patient's situation."
15752572|NCT04838171|Other|White blood cell and blood collection|Mononucleocytes will be collected via apheresis
15752573|NCT04838158|Diagnostic Test|Isokinetic measurements|Each patient underwent an isokinetic examination on Biodex System 3 (Biodex Multi-Joint System - Pro, Biodex Medical Systems, Inc. New York, USA). In the study group, both side hamstring muscle were evaluated at the velocities of 60 and180 deg/s for the following parameters: peak torque (PT), torque in 30 degree of the knee flexion (T 30 deg.), angle of peak torque (APT) and peak torque hamstring to quadriceps ratio (H/Q ratio).
15752574|NCT04838145|Drug|Ribavirin + Pleconaril|Randomized to treatment with study drugs (ribavirin and pleconaril)
15752575|NCT04838145|Drug|Placebos|Randomized to treatment with placebo
15752576|NCT04838132|Procedure|Bilateral transversus thoracis muscle plane and rectus sheath block with ropivacaine|A linear array transducer (6-13 MHz) with a sterile cover and a 22-gauge (G) block needle (KDL™, Kindly group, Shanghai, China) will be used. Place the ultrasound probe on the longitudinal plane 1 cm outside the edge of the sternum in the fourth intercostal space, and identify the T3-T4 intercostal space under ultrasound. Use the plane technique to place a 22-gauge, 80-mm needle obliquely upwards until the needle tip is located at the plane between the internal intercostal muscles and the transverse pectoralis muscle. After general anesthesia, all subjects were injected with 0.3% ropivacaine 15ml and 10ml respectively after insertion of a needle into bilateral transverse thoracic muscle plane and rectus sheath guided by B-ultrasound.
15752577|NCT04838132|Procedure|Bilateral transversus thoracis muscle plane and rectus sheath puncture with saline|A linear array transducer (6-13 MHz) with a sterile cover and a 22-gauge (G) block needle (KDL™, Kindly group, Shanghai, China) will be used. Place the ultrasound probe on the longitudinal plane 1 cm outside the edge of the sternum in the fourth intercostal space, and identify the T3-T4 intercostal space under ultrasound. Use the plane technique to place a 22-gauge, 80-mm needle obliquely upwards until the needle tip is located at the plane between the internal intercostal muscles and the transverse pectoralis muscle. After general anesthesia, all subjects were injected with 0.9% saline 15ml and 10ml respectively after insertion of a needle into bilateral transverse thoracic muscle plane and rectus sheath guided by B-ultrasound.
15752579|NCT04838093|Diagnostic Test|PCR|"Nasal or pharyngeal respiratory swabs were routinely taken of each patient admitted at our departments and repeated regularly at 48 h intervals during the inpatient stay.
~In the HCP cohort testing for SARS-CoV-2 RNA was performed, on a weekly basis, at the Department of Laboratory Medicine, Medical University of Vienna, Austria, using real-time polymerase chain reaction (RT-PCR). Comparability of the results of all test methods used was confirmed by participation in international quality control ring trials."
15752580|NCT04838080|Biological|Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine 4 µg/0.5 ml Vaccine|Two applications on Days 0 and 21
15752581|NCT04838080|Biological|Koçak-19 Inaktif Adjuvanlı COVID-19 Vaccine 6 µg/0.5 ml Vaccine|Two applications on Days 0 and 21
15752582|NCT04838080|Biological|Placebo|Two applications on Days 0 and 21
15752583|NCT04838067|Device|Cefaly|Transcutaneous trigeminal nerve electrical neuromodulation
15752584|NCT04838054|Drug|Stabilized chlorine dioxide oral rinse|Patients received stabilized chlorine dioxide rinse associated with periodontal basic therapy.
15752585|NCT04838054|Other|Placebo|Patients received a rinse containing no active ingredients and periodontal basic therapy.
15752586|NCT04838041|Drug|Asciminib|40 mg by mouth (PO) twice a day (BID).
15752587|NCT04838041|Drug|Imatinib|400 mg by mouth (PO) once daily
15752588|NCT04838028|Procedure|TEP|Laparoscopic totally extraperitoneal mesh repair of groin hernia
15752589|NCT04838028|Procedure|TAPP|Laparoscopic transabdominal mesh repair of groin hernia
15752590|NCT04838002|Device|Extracorporeal shock wave|Focus and Radial types Extracorporeal shock wave therapy
15752591|NCT04837989|Behavioral|Diabetes Body Project|Six virtually delivered Diabetes Body Project groups over six weeks (one hour a week); 5-6 participants and 2 group facilitators
15752592|NCT04837989|Behavioral|Psychoeducation|Individuals assigned to the psychoeducational control condition will receive an educational brochure, and complete similar assessments and assessment time points as the experimental condition. Individuals in the control group will be offered Diabetes Body Project group participation after six months.
15752593|NCT04837976|Other|Semi-structured interviews and a consensus workshops using nominal group techniques.|Stage 1 of the study includes individual remote semi-structured interviews (one per participant). Stage 2 involves taking part in a consensus workshop with around 7 other Parkinson's experts, consisting of patients, supportive individuals and healthcare professionals.
15752594|NCT04837950|Procedure|Diaphragmatic traction-suture|Measurement of pleural cavity volume before pulling the diaphragmatic traction-suture Measurement of pleural cavity volume after pulling the diaphragmatic traction-suture
15752595|NCT04837937|Behavioral|Caregiver vs. Patient|Participants will be assigned a 'Caregiver vs. Patient' online negotiation exercise.
15752596|NCT04837937|Behavioral|Caregiver vs. Caregiver|Participants will be assigned a 'Caregiver vs. Caregiver' online negotiation exercise.
15752597|NCT04837937|Behavioral|Caregiver vs. Physician|Participants will be assigned a 'Caregiver vs. Physician' online negotiation exercise.
15752598|NCT04837937|Behavioral|Caregiver vs. Insurance|Participants will be assigned a 'Caregiver vs. Insurance' online negotiation exercise.
15752599|NCT04837924|Procedure|fascia iliaca compartment block, (FICB) (levobupivacaine hydrochloride 0,25% 40 ml)|Land mark technique will be used to perform FICB on the side of the hip fracture. The injection site is one centimetre caudal from the junction between medial 2/3 and lateral 1/3 in the imaginary line between anterior superior iliac spine and ipsilateral pubic tubercle. The goal is to administer local anesthetic in the fascia iliaca compartment.
15752600|NCT04837924|Drug|paracetamol 1 gram IV|paracetamol 1 gram IV every six hours, 4 times in 24 hours
15752601|NCT04837924|Drug|Rescue analgesic tramadol 100 mg IV if needed|Rescue analgesic, if needed, tramadol 100 mg in 100 ml saline (0,9% Sodium chloride) IV, up to 4 times in 24 hours
15752602|NCT04837924|Procedure|Sham injection|Sting with blunt needle, (without piercing the skin), same site as fascia iliaca compartment block
15752603|NCT04837911|Device|Spirobank Smart|Patients using the Spirobank Smart
15752604|NCT04837898|Dietary Supplement|Haskapa|Haskapa Ltd, Saffron Walden, UK
15752605|NCT04837898|Dietary Supplement|Placebo|isocaloric to the haskap powder
15752606|NCT04837885|Procedure|Positron emission tomography computed tomography (PET/CT) with Intra-hepatic (IAH) injection|Intra-hepatic injection of 68Ga-DOTA-peptides for targeted liver metastases in Positron emission tomography-computed tomography (PET/CT)
15752607|NCT04837885|Procedure|Positron emission tomography computed tomography (PET/CT) with Intravenous (IV) injection|intravenous injection of 68Ga-DOTA-peptides for targeted liver metastases in Positron emission tomography-computed tomography (PET/CT)
15752608|NCT04837885|Drug|LUTATHERA® by intra-arterial hepatic (IAH) injection|"One treatment dose of LUTATHERA® by IAH injection for the 10 first patients with an PET/CT ratio greater then 3.
~The LUTATHERA® by intra-arterial hepatic injection treatment is realised after the conventional treatment by 4 intravenous administrations"
15752609|NCT04837885|Procedure|Scan|Scans after completion of LUTATHERA® treatment injection
15752610|NCT04837872|Other|Multimodal Physical Therapy (MPT)|Individualized physical therapy and static progressive splint (flexion with or without extension splint).
15752611|NCT04837859|Drug|Tislelizumab|age 18-60: Tislelizumab alone or in combination with AVD (depending on the PET result after 2x Tislelizumab) followed by IS-RT if PET positive resudues after the end of Tis or Tis-AVD age 60+: Tislelizumab alone or in combination with AVD (depending on the PET result after 2x Tislelizumab) followed by IS-RT for all patients
15752612|NCT04837846|Other|Differing Tube Voltage Administration|Subjects will undergo CCTA utilizing a scan and contrast media injection protocol that will be tailored to individual body habitus.
15752613|NCT04837833|Diagnostic Test|ultrasound|Participants will undergo research ultrasound (rUS1) within two days of their routine CECT scan. A subset of participants will undergo a second research US (rUS2) at 3-4 weeks after rUS1 and at least one month prior to the next planned clinical CECT
15752614|NCT04837820|Procedure|Acupuncture|Each participant will receive 10 treatments of acupuncture (real or sham) over the course of 10 weeks (i.e. one treatment a week) with a +/- 14-day window.
15752615|NCT04837820|Procedure|Sham Acupuncture|Each participant will receive 10 treatments of acupuncture (real or sham) over the course of 10 weeks (i.e. one treatment a week) with a +/- 14-day window.
15752616|NCT04837820|Other|Wait-List Control (WLC)|Patients in the WLC group will continue to receive their standard medical care as prescribed by their oncologists/primary care physicians.
15752617|NCT04837820|Other|Questionnaires|Will follow patients for 26 weeks from baseline and collect assessments at baseline and Weeks 4, 10, 14, and 26. Average time to complete the patient-reported outcomes (PROs) is 30 minutes, which has been judged to be acceptable with minimal missing data;. 20 minutes of these 30 minutes will be completed during the neurocognitive battery.
15752618|NCT04837807|Drug|Systane Hydration PF|This is an over-the-counter preservative free artificial tear that can be purchased at most retail stores and pharmacies.
15752619|NCT04837794|Device|Digital Pain-Management Tool|Digital Pain-Management Tool
15752620|NCT04837781|Procedure|Micro-osteoperforation|Micro-osteoperforation Mini-implant facilitated micro-osteoperforation (MOPs) were placed in the experimental side before canine retraction. Three MOPs were placed distal to canine on experimental sides in all group.
15752621|NCT04837768|Drug|Twice-daily transvaginal progesterone supplementation|Patients with serum progesterone levels >9.2 ng/ml on the day of embryo transfer in artificial frozen cycles will receive the traditional twice-daily vaginal progesterone supplementation till 12 weeks gestation.
15752622|NCT04837768|Drug|Twice-weekly intramuscular + Twice-daily transvaginal progesterone supplementation|Patients with serum progesterone levels <9.2 ng/ml on the day of embryo transfer in artificial frozen cycles will receive the twice-daily vaginal progesterone in addition to twice-weekly intramuscular progesterone supplementation till 12 weeks gestation.
15752623|NCT04837755|Diagnostic Test|Cytokine measurements|The serum concentrations of multiple cytokines are measured.
15752624|NCT04837742|Drug|ESPB group|ESPB injection at T8 region with Chirocaine 100mg(20 cc)+ Omipaque 10cc
15752625|NCT04837742|Drug|Control group|ESPB injection at T8 region with Normal saline 20cc + Omnipaque 10cc
15752626|NCT04837729|Other|Acupressure|acupressure is a non-pharmacological method originating from traditional Chinese medicine. According to the National Cancer Institute, acupressure is defined as pressure / massage applied to certain parts of the body to control symptoms such as pain or nausea. The main purpose of acupressure is to stimulate the regions associated with the specific organ by applying pressure with energy channels called meridians.
15752627|NCT04837716|Biological|Bevacizumab|Given IV
15752628|NCT04837716|Drug|Carboplatin|Given IV
15752629|NCT04837716|Drug|Ensartinib|Given PO
15752630|NCT04837716|Drug|Pemetrexed|Given IV
15752631|NCT04837703|Drug|Eltrombopag|Eltrombopag should be taken at least two hours before or four hours after any products such as antacids, dairy products, or mineral supplements containing polyvalent cation (e.g. aluminum, calcium, iron, magnesium, selenium and zinc). Eltrombopag may be taken with food containing little (< 50 mg) or preferably no calcium.
15752632|NCT04837690|Procedure|UEMR|(1) the colorectal lumen was completed deflated with 500-1000 mL sterile water using a flushing pump; (2) the lesion and 2-3 mm of normal mucosa surrounding the base of the polyp were snared and subsequently resected with an electrosurgical generator
15752633|NCT04837677|Drug|PRT1419|PRT1419 will be administered by intravenous infusion
15752636|NCT04837664|Drug|Nystatin|Rinsing with topical nystatin (100,000 UI/mL) suspension for 60 seconds
15752637|NCT04837651|Device|Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test|Subjects will receive an Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test within 4 weeks of receiving their first COVID-19 injection. Within 3-4 weeks of receipt of their final COVID-19 vaccine dose, subjects will receive another Elecsys semi-quantitative Anti-SARS-CoV-2 antibody test.
15752638|NCT04837651|Device|T-Detect COVID T-cell blood test|A select number of subjects will also receive a qualitative SARS-CoV-2 t-cell immunity test, the T-Detect COVID test, within 3-4 weeks of receipt of their final COVID-19 vaccine dose.
15752639|NCT04837638|Behavioral|Diet|No intervention. Cross-section assessment of the relationship between diet, medication, lifestyle and coronary artery calcification.
15752640|NCT04837625|Other|no interventions|no interventions
15752641|NCT04837612|Other|No intervention nor exposure|As an observational study, no intervention nor exposure is interested.
15752642|NCT04837599|Device|Discovery TM of Pentax medical on/off in colonoscopy|on the monitor artificial integlligence Discovery can be switched on or off.
15752643|NCT04837586|Other|Standard Care|Individuals will receive standard care for their obesity through the Pediatric Weight Management Clinic.
15752644|NCT04837586|Device|Simple Scale|Individuals will be encouraged to perform daily weighing at home on a simple scale.
15752645|NCT04837586|Device|EHR-Connected Scale|Individuals will be encouraged to perform daily weighing at home on a Smart scale that connects to the EHR. Clinic staff will review weight entries in the EHR and provide feedback.
15752646|NCT04837573|Behavioral|Sister Circle protocol|The intervention is an 8-week, therapeutically-informed protocol.
15752647|NCT04837560|Device|ElastiMed's SACS 2.0|A wearable medical device that improve circulation using smart materials
15752648|NCT04837547|Biological|Tumor-specific ex vivo expanded autologous lymphocyte transfer (TTRNA-xALT)|There will be two immunotherapy products manufactured and administered to subjects enrolled on this trial. The first product will be autologous dendritic cells (DCs) loaded with total tumor messenger ribonucleic acid (mRNA) (TTRNA) derived from malignant tumors. The second product will be autologous T lymphocytes stimulated ex vivo against TTRNA antigens for autologous transfer (TTRNA-xALT). DCs are professional antigen-presenting cells critical for the initiation of B and T-cell responses in vivo.
15752649|NCT04837534|Behavioral|Counseling group|In this group after the children have been examined, treatment plan and follow up schedule been advised by a pediatric ophthalmologist, parents/guardians along with the child will receive counseling from a trained counselor as per the set counseling protocol in every follow-up visits and will also be provided with the disease-specific information leaflets as an additional information material before the child is discharged from the department.
15752650|NCT04837534|Behavioral|SMS and phone call reminder group|In this group after the children have been examined, treatment plan, and the follow-up schedule been advised, they will be discharged from the department but later they will receive reminders through short messaging text (SMS) and phone calls as per the set protocol.
15752651|NCT04837521|Behavioral|Unified Protocol|Five session psychotherapy
15752652|NCT04837508|Drug|MRG002|Administrated intravenously
15752653|NCT04837495|Procedure|right stellate ganglion block|The skin should be anaesthetised with lidocaine 2%. Using a lateral approach and in-plane imaging, a blunt regional anaesthesia needle should be advanced deep to the carotid sheath towards the longus colli muscle. Following careful aspiration, inject 10 ml lidocaine 2% that will result in expansion of the fascia of the longus colli. Confirmation of the SGB success can be detected by warming of left upper limb and left Horner's syndrome.
15752654|NCT04837482|Drug|AGN-190584|Topical eyedrop
15752655|NCT04837469|Procedure|fissure sealant application|fissure sealants were placed after differnt adhesive strategies used
15752656|NCT04837456|Dietary Supplement|Calorie restricted diet and exercise intervention|the calorie restricted diet were prescribed a balanced diet that provided an energy deficit of 800 kcal/day from their daily energy requirement.Macronutrient content of low caloric diet, expressed as percentage of ingested energy with carbohydrates 45-65%; fat 20-35%; and protein 10- 35%[36]. Participants were guided by a dietitian for adjustments of their caloric intake weekly for six months.Participants performed 1 or 2 sets at a resistance of approximately 65% of their one-repetition maximum, with 8 to 12 repetitions of each exercise; they gradually increased the intensity to 2 to 3 sets at a resistance of approximately 80% of their one-repetition maximum, with 6 to 8 repetitions of each exercise.
15752657|NCT04837456|Procedure|libitum diet and waiting list control group|libitum diet and waiting list control group, participants then underwent a calorie of 2000 calorie above based on libitum free diets recommended to adults and normal physical activity without exercise during the program.
15752658|NCT04837456|Procedure|Early arthroscopic partial menisectomy group|Early APM group participants received APM with syndrome within 3 to 6 months
15752659|NCT04837456|Procedure|delayed APM group recruit participants with symptoms lasting for more than 6 months|delayed APM group recruit participants with symptoms lasting for more than 6 months
15752660|NCT04837443|Behavioral|Rubber hand illusion|Tactile sensory threshold from quantitative sensory tests, two point discrimination from cortical senses, pressure pain threshold measured by algometer will be examined during and after the rubber hand burning, which causes changes in body perception.
15752661|NCT04837417|Diagnostic Test|Pathologic group|"Voluntary Activation level will be determined with the interpolate twitch technique (ITT), both during isometric contractions (knee at 40° flexion) and during isokinetic contraction at angular velocity equal to 100°/s.
~Vastus Medialis and Soleous H-reflex will be measured. Cortical excitability and interhemispheric connectivity will be measured through transcranial magnetic stimulation (TMS).
~Tests of balance in standing will be performed using the EquiTest platform. Individuals will be requested to perform three different tasks: Sensory Organization test, Adaptation Test upward/downward, Motor Control test backward/forward. Surface electromyography from lower limbs will be recorded.
~Through TMS driven by neuronavigation, the cortical representation of the Quadriceps muscle will be studied.
~Gait analysis will be performed on a treadmill mounted on force sensors. Participants will walk at increasing velocities from 0.4 m/s to 1.6 m/s. Speed will be increased of 0.2 m/s every 30 s."
15752662|NCT04837404|Procedure|Ultrasound guided femoral access for complex PCI|Ultrasound guided femoral access for complex PCI
15752663|NCT04837404|Procedure|Fluoroscopy guided femoral access for complex PCI|Fluoroscopy guided femoral access for complex PCI
15752699|NCT04837118|Other|Educational Intervention|Receive handouts containing dietary recommendations
15752664|NCT04837391|Device|Near Infrared Spectroscopy (NIRS)|Patients are monitored by near infrared spectroscopy before anesthesia induction until end of the operation. Graphical presentation of cerebral oxygenation during surgery evaluated by INVOS Analytics Tool Version 1.2.
15752665|NCT04837391|Diagnostic Test|Blood sample|Blood samples are obtained before and after surgery. S-100, Neuron specific enolase (NSE), Interleukin-6 (IL-6), High Mobility Group Box Protein (HMGB-1) are going to be studied by ELISA method after data collection process end.
15752666|NCT04837391|Diagnostic Test|Addenbrooke Cognitive Examination III (ACE-III)|ACE-III is administered to study participants one day before surgery, 1 week after surgery, and three months after surgery to diagnose postoperative cognitive dysfunction.
15752667|NCT04837391|Diagnostic Test|Confusion Assessment Method|Confusion Assessment Method is administered to study participants in postoperative recovery room to diagnose postoperative delirium.
15752668|NCT04837378|Other|Abdominal Massage|The massage starts from the left lower quadrant of the sigmoid colon. After the initial tension is removed, deep effloration, petrization and vibration maneuvers are started. Finally, the process is completed in about 15 minutes to cover the entire column.
15752669|NCT04837378|Other|In-bed Exercise|In-bed exercises are passive exercises performed by caregivers when the patient is dependent on the bed, that is, when he cannot actively move on his own. These are movements applied to all joints of the upper and lower extremities and in all directions. Exercises are done in all directions on finger joints of both hands, wrists, elbow and shoulder joints, finger joints of both feet, ankles, knee and hip joints.
15752671|NCT04837352|Other|Study of the role of sociocognitive factors|Questionnaires
15752672|NCT04837339|Other|Collection of biological samples|Blood sample, biopsies sample, hair sample.
15752673|NCT04837326|Other|Heel Lance Blood Sampling in Facilitated Tucking Position|
15752674|NCT04837326|Other|Heel Lance Blood Sampling When the Infant is Embraced by the Mother|
15752675|NCT04837326|Other|Heel Lance Blood Sampling Using White Noise|
15752676|NCT04837313|Procedure|Fecal Microbiota Transplantation|Fecal Microbiota Transplantation
15752677|NCT04837300|Other|Resisted Sprint Traininig|The Participants in this group had received plyometrics exercises; double leg jumping, drop jumping, hopping, bounding and hurdling.
15752678|NCT04837287|Other|Static Stretching Exercise for 10 Seconds|The participants were asked to do a static stretching exercise for the Hamstring and Gracilis muscles for 10 seconds. The participants were asked to continue for 8 weeks, 3 days a week, 3 times a day - 10 repetitions.
15752679|NCT04837287|Other|Static Stretching Exercise for 30 Seconds|The participants were asked to do a static stretching exercise for the Hamstring and Gracilis muscles for 30 seconds. The participants were asked to continue for 8 weeks, 3 days a week, 3 times a day - 10 repetitions.
15752680|NCT04837274|Dietary Supplement|Placebo|Dextrose (480 mg)
15752681|NCT04837274|Dietary Supplement|Active|Tary Cherry (480 mg)
15752682|NCT04837261|Drug|Propranolol|3 mg/kg/d, divided in four doses when age less than 3 months and in three doses when age more than 3 months
15752683|NCT04837261|Drug|Flecainide|80 mg/m2/d
15752684|NCT04837261|Drug|Amiodarone|Single dose of 10 mg/kg/d 10-14 days, 5 mg/kg/d
15752685|NCT04837248|Other|Active Comparator: Group 1. Conventional treatment|"Patients will be treated using a physiotherapy programme without digital support. A written document with exercises and recommendations will be given to them on the first day. This booklet will detail the exercises they can do depending on their surgery and the weeks elapsed, as well as the recommendations adapted according to the needs identified in the motivational interview (MI). This is the treatment that is currently being applied in the hospital.
~The patient will carry out the treatment at home and will come back after 20 sessions for the corresponding assessment."
15752686|NCT04837248|Other|Experimental: Group 2. Experimental treatment.|"A digitally supported physiotherapy programme including:
~Group session: expectations, interests, experiences with regard to their health problem and the consequences on their life, joint exercise and discussion with subsequent debate will be held.
~Exercise session: each week, patients will find different exercise videos on the platform according to the phase of recovery in which each one of them is, having been previously evaluated in the group session.
~Relaxation session: this will be carried out by means of audio that will be posted on the platform and that the patient will be able to perform simultaneously.
~Empowerment session: audio sessions that will deal with those needs that frequently arise after breast surgery in their daily lives, focusing on limiting beliefs (e.g. fear of moving), positive thoughts and information extracted from the motivational interview that should be developed."
15752688|NCT04837222|Other|No Intervention|This is a non-interventional study.
15752689|NCT04837209|Drug|Niraparib|Capsule, taken by mouth
15752690|NCT04837209|Drug|Dostarlimab|Intravenous infusion
15752691|NCT04837209|Radiation|Radiation therapy|Radio Therapy
15752694|NCT04837170|Drug|Conventional therapy + S (+)-Ketamine|Patients who undergo general anesthesia using S(+)-ketamine hydrochloride for anesthesia induction,maintenance or postoperative analgesia.
15752695|NCT04837170|Drug|Conventional therapy|Receiving conventional therapy without S (+)-Ketamine hydrochloride injection. There is no restrictions in drugs, doses and incompatibility, the researchers can choose appropriate medication regimens based on clinical practice, but other NMDA receptor antagonists are not be allowed to use, such as dextromethorphan and amantadine.
15752696|NCT04837157|Device|Exoskeleton rehabilitation|The participants will perform physical therapy with the ATLSA2030 device, for 90 minutes per session.
15752697|NCT04837144|Device|Physical Rehabilitation with MAK exoskeleton|The participants will assist to 9 physical rehabilitation sessions with the MAK exoskeleton. During these sessions, different movements and therapies will be conducted using the studied device.
15752698|NCT04837131|Drug|Ixazomib|Ixazomib 4 mg capsule taken orally on days 1, 8, and 15 of a 28-day treatment cycle repeated for 6 cycles
15752703|NCT04837105|Other|Serious game ARROW CP|"ARROW CP is developed for Microsoft Hololens headset. Feedback on gait performance are delivering to the participant in real time and with delay. Participants have to walk at their maximal speed during sprint session."
15752704|NCT04837105|Other|Treadmill|Participant walk on a treadmill at 80% of their maximal speed during maximum 20 minutes
15752705|NCT04837092|Drug|FR104|FR104 treatment administration at day 0, day 14 then every 28 days until month 12
15752706|NCT04837079|Other|Clinical observational study|Clinical observational study
15752707|NCT04837066|Diagnostic Test|Dynamic Vision Testing (Bertec Vision Advantage System) and Balance Error Scoring System|Assessment tool and computerized tests designed to evaluate postural stability and vestibulo-ocular reflex (VOR) function while assisting with return to play decision after a sports-related concussion.
15752708|NCT04837053|Other|Digital decision aid for physicians and patients|The intervention consists of three parts: (1) the EKIT tool provides a systematic presentation of individual patient and disease-specific information; (2) it visualizes the fulfilment of the indication criteria recommanded in corresponding german guideline; (3) it presents health information about total knee replacement.
15752709|NCT04837053|Other|Routine care|Care as usual within the included study sites.
15752710|NCT04837040|Drug|Paltusotine|Paltusotine, tablets, once daily by mouth
15752711|NCT04837040|Drug|Placebo|Placebo, tablets, once daily by mouth
15752712|NCT04837027|Behavioral|Aerobic training|Aerobic training on stationary bike 5x a week for 30 minutes a day
15752713|NCT04837027|Behavioral|Balance training|Training 5x a week for 30 minutes. Standard of care
15752714|NCT04837014|Other|prescription for regular acetaminophen and naproxen|Patient allocated to the intervention arm will be discharged home with a prescription for regular acetaminophen and naproxen for 48 hours, and then prn for one week's duration. No narcotic will be prescribed at discharge post-operatively.
15752715|NCT04837014|Other|prescription for regular acetaminophen , naproxen and dilaudid|prescription for regular acetaminophen , naproxen and dilaudid
15752718|NCT04836988|Other|Three months of digitally delivered osteoarthritis treatment|Digitally delivered osteoarthritis management including education and exercise and weight control if needed
15752719|NCT04836988|Other|Three months of face-to-face delivered osteoarthritis treatment|Face-toface delivered osteoarthritis management including education and exercise and weight control if needed
15752720|NCT04836962|Drug|normal saline|2cc of normal saline is administered to patient instead of dexamethasone.
15752721|NCT04836962|Drug|dexamethasone|dexamethasone is administered 0.5mg/kg (up to 10mg) which is diluted with normal saline to make a total of 2cc.
15752722|NCT04836949|Device|Shear Wave Elastography of prostate|A 12-core template biopsy is planned as during a conventional prostate biopsy. The prostate is divided in to 1) Rt apex, 2) Rt mid, 3) Rt base, 4) Rt apex lateral, 5) Rt mid lateral, 6) Rt base lateral, 7) Lt apex, 8) Lt mid, 9) Lt base, 10) Lt apex lateral, 11) Lt mid lateral, and 12) Lt base lateral areas. The elasticity of each area is evaluated and region with the maximum Young's modulus value is selected and targeted for biopsy. Additional biopsy for suspicious lesions can be performed at the discretion of the practitioner.
15752723|NCT04836949|Device|Conventional Prostate Ultrasound|A conventional 12-core template biopsy is planned. The prostate is divided in to 1) Rt apex, 2) Rt mid, 3) Rt base, 4) Rt apex lateral, 5) Rt mid lateral, 6) Rt base lateral, 7) Lt apex, 8) Lt mid, 9) Lt base, 10) Lt apex lateral, 11) Lt mid lateral, and 12) Lt base lateral areas. Random biopsy of each area is performed. Additional biopsy of suspicious hypoechoic nodular lesions can be performed at the discretion of the practitioner.
15752724|NCT04836936|Device|Auriculotherapy cryopuncture device without nitrogen gas|Auriculotherapy cryopuncture device without nitrogen gas will be administered. Application of this placebo device will be performed in the same manner as the treatment, but without the expulsion of nitrogen gas.
15752725|NCT04836936|Device|Auriculotherapy cryopuncture device with nitrogen gas|Auriculotherapy cryopuncture device with nitrogen gas will be administered. The tip of the cryopuncture will be sanitized and placed on each treatment point of the ear, releasing a spurt of nitrogen gas for 2 seconds on each point (6 points total).
15752726|NCT04836923|Behavioral|"LIver FrailTy intervention (LIFT)"|Novel physical therapy intervention to decrease frailty in pre-transplant patients
15752727|NCT04836923|Behavioral|"Realistic Effort Action Planning intervention (REAP)"|This intervention is an interactive behavioral interviewing process to engage patients in their care
15752728|NCT04836910|Other|Dietary recommendations|"Fruit, vegetables, legumes (e.g. lentils and beans), nuts and whole grains (e.g. unprocessed maize, millet, oats, wheat and brown rice).
~At least 400 g (i.e. five portions) of fruit and vegetables per day excluding potatoes, sweet potatoes, cassava and other starchy roots.
~Less than 10% of total energy intake from free sugars Less than 30% of total energy intake from fats. Unsaturated fats (found in fish, avocado and nuts, and in sunflower, soybean, canola and olive oils) are preferable to saturated fats.
~Less than 5 g of salt (equivalent to about one teaspoon) per day."
15752729|NCT04836910|Drug|Oral contraceptive pills|Hormonal treatment
15752730|NCT04836910|Drug|Metformin|Insulin resistance treatment
15752731|NCT04836897|Device|PrizValve® valve and transapical delivery system|Transcatheter aortic valve replacement system
15752732|NCT04836884|Procedure|Percutaneous Vascular Anomaly/Malformation Biopsy|US-guided percutaneous vascular anomaly core needle biopsy of up to 10 cores using an 18-gauge co-axial core needle biopsy device at the time of clinically indicated sclerotherapy, embolization or ablation treatment.
15752733|NCT04836871|Combination Product|DFPP combined with chemotherapy|Double filtration plasmapheresis combined with chemotherapy
15752734|NCT04836858|Biological|CMK389|Active
15752735|NCT04836858|Biological|Placebo|Placebo Comparator
15752736|NCT04836845|Device|Focus extracorporeal shock wave therapy|Focus extracorporeal shock wave therapy, device: Electronica, Pagani, Italy
15752737|NCT04836845|Device|Radial extracorporeal shock wave therapy|Radial extracorporeal shock wave therapy, device: Electronica, Pagani, Italy
15752738|NCT04836845|Device|Sham extracorporeal shock wave therapy|Sham extracorporeal shock wave therapy, device: Electronica, Pagani, Italy
15752741|NCT04836819|Drug|Lidocain|IV lidocaine infusion (2 mg/kg/h) will be initiated after anesthesia induction and decrease the dosage to 1 mg/kg/h at the end of surgery. The infusion will continue until 12 hours after the operation.1 g paracetamol, 100 mg tramadol, 100 mg ketoprofen, and 4 mg dexamethasone will be administered to all patients pre-emptively. Granisetron (3 mg) will be administered 30 minutes before the end of surgery. In the postoperative period, i.v. Paracetamol will be administered at 8-hour intervals and 25-50 mg meperidine i.m. (maximum dose 200 mg) as rescue analgesia when requested by the patient and if VAS>4.
15752742|NCT04836819|Drug|Ketamine|IV ketamine infusion (0.5 mg/kg/h) will be initiated after anesthesia induction and decrease the dosage to 0.3 mg/kg/h at the end of surgery. The infusion will continue until 12 hours after the operation.1 g paracetamol, 100 mg tramadol, 100 mg ketoprofen, and 4 mg dexamethasone will be administered to all patients pre-emptively. Granisetron (3 mg) will be administered 30 minutes before the end of surgery. In the postoperative period, i.v. Paracetamol will be administered at 8-hour intervals and 25-50 mg meperidine i.m. (maximum dose 200 mg) as rescue analgesia when requested by the patient and if VAS>4.
15752743|NCT04836819|Drug|Dexmedetomidine|IV dexmedetomidine infusion (0.5 mg/kg/h) will be initiated after anesthesia induction and decrease the dosage to 0.3 mg/kg/h at the end of surgery. The infusion will continue until 12 hours after the operation.1 g paracetamol, 100 mg tramadol, 100 mg ketoprofen, and 4 mg dexamethasone will be administered to all patients pre-emptively. Granisetron (3 mg) will be administered 30 minutes before the end of surgery. In the postoperative period, i.v. Paracetamol will be administered at 8-hour intervals and 25-50 mg meperidine i.m. (maximum dose 200 mg) as rescue analgesia when requested by the patient and if VAS>4.
15752744|NCT04836806|Drug|Cetirizine and Famotidine|Participants will take 10 milligrams (mg) of cetirizine once a day and 20 mg of famotidine twice a day for 10 days (two pills in the morning and one in the evening).
15752745|NCT04836806|Drug|Placebo|Participants will take placebos to match 10 mg of cetirizine once a day and 20 mg of famotidine twice a day for 10 days (two pills in the morning and one in the evening).
15752746|NCT04836793|Other|Additional biological samples|Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected
15752747|NCT04836780|Drug|Dexamethasone|Dexamethasone base 6 mg once daily for seven days
15752748|NCT04836741|Device|Micro Hand S robot|The surgeries are performed with the Micro Hand S robot
15752749|NCT04836741|Device|Laparoscope|The surgeries are performed with the laparoscope
15752750|NCT04836728|Biological|CIK cell injection|CIK cells, more than 1x10^10 (10 billion ), intravenous infusion,d14; Q3W.
15752751|NCT04836728|Drug|Sintilimab Injection|Sintilimab Injection intravenous infusion 200mg d1
15752752|NCT04836728|Drug|Pemetrexed|Pemetrexed intravenous infusion 500mg/m2 d2
15752753|NCT04836728|Drug|Albumin paclitaxel|Albumin paclitaxel intravenous infusion 260mg/m2 d2
15752754|NCT04836728|Drug|Carboplatin|Carboplatin intravenous infusion AUC5 d2
15752755|NCT04836689|Device|nasal intermittent positive pressure ventilation (NIPPV).|"NIPPV will be administered using Leoni (Heinen&Löwenstein, Bad Ems, Germany) and RAM cannula (Neotech, Valencia, CA).
~After initial setting and before routine blood gas testing, tcCO2 will be connected and calibrated. We will use SenTec digital monitor (SenTec AG, Therwil, Switzerland). Correlation/agreement between the tcCO2 and PCO2 will be assessed and documented in each infant.
~For Each infant we will get 2 set of data: Change in measurements when changing from 30 bpm to 10 bpm, and change in measurements when changing from 10 bpm to 30 bpm At the end of each hour, before rate change, we will document the following measurements:TcCO2, FiO2, saturation, the infant's respiratory rate (as measured in the monitor), number of apneas, bradycardia (heart rate<100 bpm), saturation<90% and>94% episodes (as measured in the monitor), 1-hour saturation histogram clasification."
15752756|NCT04836676|Device|C-REX Device|"The investigational devices are C-REX LapAid Cath or C-REX RectoAid Cath. C-REX LapAid Cath consists of an invasive surgical part, i.e. anastomotic ring comprised of two LapAn coupled by DMC/DM, intended for short-term use, and surgical instruments for assisting the placement of the anastomotic ring to intestine.
~C-REX RectoAid Cath consists of an invasive surgical part, i.e. an anastomotic ring comprised of RectoAn and LapAn, intended for short-term use, and surgical instruments for assisting the placement of the anastomotic ring to intestine.
~C-REX LapAid Cath and C-REX RectoAid Cath are easy to use, with unique possibility to control and validate the integrity of the anastomosis during and after surgery."
15752757|NCT04836663|Drug|TQ-B3525 tablet|TQ-B3525 tablet administered orally once a day. Each cycle is 28 days.
15752758|NCT04836650|Diagnostic Test|Postural stability assessment with a force platform.|The postural stability will be assessed in static by means of the antero-posterior and medio-lateral displacements of the center of pressure in Romberg open and closed eyes test measured with a force platform (NED/SVE-IBV-Spain). Three 30-second measurements will be made in each condition.
15752759|NCT04836650|Diagnostic Test|Muscular assessment with a electromyograph|The activity of the medial and lateral gastrocnemius, soleus and anterior tibial muscles of the dominant leg will be assessed with the mDurance surface electromiograph at the same time as postural stability analysis is performed.Three 30-second measurements will be made in each condition.
15752760|NCT04836637|Dietary Supplement|Maltodextrin|Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily.
15752761|NCT04836637|Dietary Supplement|Calcium-carbonate|Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily.
15752762|NCT04836637|Dietary Supplement|Calcium-enriched permeate|Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily.
15752763|NCT04836637|Dietary Supplement|Calcium-enriched permeate with Inulin|Three capsules are to be consumed with one sachet dissolved in 200 ml. of water for breakfast and later for dinner resulting in a total of six capsules and two sachets via oral consumption daily.
15752837|NCT04836000|Other|In addition to the conservative treatment, Low-level laser therapy (turned off)|For Placebo Group In the placebo group, laser instrument will be applied in the same way but the device will be turned off during treatment sessions. Patients and physiotherapist will be asked to use protective eyeglasses during therapy for safety.
15753227|NCT04832854|Drug|Gemcitabine|Gemcitabine at 1000 or 1250 mg/m^2 will be administered by IV infusion on Days 1 and 8 of each 21-day cycle.
15752764|NCT04836624|Device|Co-designing of personalised aids of daily living|"In the initial session the researcher will work with the participants to identify challenges in daily living for the device to overcome.
~In between sessions the researcher will design and manufacture different solutions which will then be sent out for the participant to trial. The participant will then meet with the researcher to and feedback on the device provided. Feedback from the user is used to alter and improve the design of the device; new device(s) are then , enabling the design to be adapted to the participants needs. The process of design changes and feedback forms an iterative loop. This is expected to continue for 4-5 appointments over a period of serveral months until a final design is agreed upon.
~After the device is issue, both qualitative and quantitative outcome measures are provided to participants to complete, including questionnaires and semi-structured interviews. ."
15752765|NCT04836611|Procedure|1 blood sample|2 groups of subjects (group 1 : with diagnosis of CHS - group 2 : no diagnosis of CHS) will have 2 blood and 1 urine samples + 1 questionnaire
15752766|NCT04836598|Other|laparoscopic cholecystectomy|A Prospective randomized controlled trial study was undertaken along 4 years Between November 2016 and October 2020, in two institutions. 400 patients were selected, 200 patients underwent BLLC and 200 patients underwent multiple port laparoscopic cholecystectomy (MPLC).
15752767|NCT04836585|Other|eMBC Intervention|"The treating psychiatrist sets a flag in the patient's electronic chart that prompts them to complete self-report scales prior to each appointment:
~Edinburgh Postnatal Depression Scale (EPDS) for symptoms of depression and anxiety
~PROMIS Neuro-QOL and PROMIS ASCQ-Me Social Functioning Short form for measures of functional capacity
~Adapted Frequency, Intensity, and Burden Side Effects Rating (FIBSER) Scale for participants taking antidepressant medication to measure side effects
~Patient participants and providers can view the questionnaire results over time in the electronic chart item by item, and/or see them in graphical format. During the clinical encounter, the provider and patient participant review the results of the scales, as part of a collaborative re-evaluation of the treatment plan."
15752768|NCT04836572|Other|3M 1529 Adhesive Tape|5-12 hour adhesive wear
15752771|NCT04836546|Device|Blood glucose meter|First phase: SMBG for 6 months
15752772|NCT04836546|Device|Eversense CGM System|Second phase: CGM for 6 months
15752773|NCT04836533|Other|Experimental: Computerized Cognitive Training|Participants will complete 4 weeks of executive functioning / processing speed training through the BrainHQ platform on their personal computers.
15752774|NCT04836533|Drug|Experimental: Open-label antidepressant treatment|Participants will be assigned to open-label or placebo-controlled antidepressant treatment for 8 weeks.
15752775|NCT04836533|Other|Active Comparator: Solitaire Training|Participants will complete 4 weeks of Solitaire training through the BrainHQ platform on their personal computers.
15752776|NCT04836533|Other|Placebo Comparator: Placebo-controlled antidepressant treatment|Participants will be told they have a 50/50 chance of receiving a placebo or antidepressant.
15752777|NCT04836520|Drug|SHR6390+anatrozole|SHR6390 is a novel small molecule inhibitor specifically targeting the CDK4/6 pathway.
15752778|NCT04836507|Biological|CRC01|A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg.
15752779|NCT04836507|Drug|Fludarabine|Administered according to package insert
15752780|NCT04836507|Drug|Cyclophosphamide|Administered according to package insert
15752781|NCT04836494|Drug|BBP-671|BBP-671, oral suspension
15752782|NCT04836494|Drug|Placebo|Placebo matching BBP-671
15752783|NCT04836481|Other|Serum Sample Collection|Each patient will have 5 serum samples collected for analysis after a minimum six consecutive doses. Patients receiving LEV8 will have sampled collected at hours 0.5, 1, 4, 6, and 8. Patients receiving LEV12 will have sampled collected at hours 0.5, 1, 4, 8, and 12.
15752784|NCT04836468|Diagnostic Test|Tape application|Magnetic Tape or Kinesiology tape will be applied randomly with both the examiner and the subjects blinded.
15752785|NCT04836455|Behavioral|The FDA's The REal Cost vaping prevention ads - Health harms theme|Three vaping prevention video ads from the FDA's The Real Cost prevention campaign about the health harms of vaping will be shown to participants at weeks 0, 1, and 2. Ads will be shown in a random order.
15752786|NCT04836455|Behavioral|The FDA's The Real Cost vaping prevention ads - Addiction theme|Three vaping prevention video ads from the FDA's The Real Cost prevention campaign about vaping addiction will be shown to participants at week 0, 1, and 2. Ads will be shown in a random order.
15752787|NCT04836455|Behavioral|Neutral vaping ads|Three neutral (i.e., purely informational and without graphics) vaping video ads developed by the Investigators will be shown to participants at weeks 0, 1, and 2. Ads will be shown in a random order.
15752788|NCT04836442|Other|Alcohol-PTSD-PFI (AP-PFI)|Integrated computer-based personalized feedback intervention to specifically target anxiety sensitivity in the context of hazardous drinking and PTSD symptoms. The AP-PFI will focus on feedback about alcohol behavior in the context of PTSD symptoms, AS, and coping-oriented alcohol use.
15752789|NCT04836442|Other|Attention Information control condition (C-PFI)|Participants in the control group will receive a time-matched, attention information control intervention (C-PFI) that will focus on facts about the host city. Participants in the attention information control PFI will receive facts about the host city, retrieved from official city sources. To increase attention and match the format of the active condition, videos about the city will be shown and questions about the city will be asked. Correct responses will be validated and inaccurate responses will be corrected with on-screen messages. The C-PFI will not address drinking reduction, PTSD, or anxiety sensitivity.
15752790|NCT04836429|Drug|Porfimer Sodium|Given IV
15752791|NCT04836429|Procedure|Video-Assisted Thoracic Surgery|Undergo VATS
15752792|NCT04836429|Drug|Photodynamic Therapy|Undergo photodynamic therapy
15752793|NCT04836429|Device|Intraoperative PDT|Subjects will receive one course of light therapy at the time of surgery
15752794|NCT04836416|Other|Observational|Observational
15752874|NCT04835714|Drug|BI 1701963|BI 1701963
15752875|NCT04835714|Drug|BI 3011441|BI 3011441
15752955|NCT04834973|Drug|pembrolizumab|"Three weekly 200 mg intravenous pembrolizumab treatment.
~Pembrolizumab is a systemic anti-programmed cell death receptor 1 (PD 1) immunotherapy."
15752795|NCT04836403|Other|Sinus and nasal quality of life survey questionnaire (SN-5)|"The SN-5 consists of five questions on a 7-point scale that assesses the frequency of the following symptoms: (1) nasal obstruction, (2) sinus infection, (3) allergies, (4) emotional distress, and (5) activity limitations. The scoring system is as follows: 1 indicates none of the time, 2 indicating hardly any time at all, 3 indicates a small part of the time, 4 indicates some of the time, 5 indicates a good part of the time, 6 indicates most of the time, and 7 indicates all of the time. Higher scores indicate more severe sinonasal symptoms. One item from a global faces scale scored from 0 to 10 is used to evaluate overall QoL related to nasal or sinus disease. Higher scores on this scale indicate a less severe impact of nasal or sinus disease. The scores from the first five items (1-7 each)"
15752797|NCT04836377|Other|Safety and efficacy assessments|Safety evaluations, disease-specific assessments, and other assessments to monitor for long-term complications of gene therapy intervention
15752798|NCT04836364|Other|No Intervention|There is no intervention; observation only.
15752799|NCT04836351|Other|Concentrated rehabilitation for patients with persistent symptoms post COVID-19|3+ 1-2 days concentrated rehabilitation for patients with persistent symptoms post COVID-19 with a mobile application follow-up and physical consultations at 3 months post intervention.
15752800|NCT04836338|Device|orotracheal intubation|orotracheal intubation
15752801|NCT04836325|Procedure|transcranial static magnetic field stimulation (tSMS)|The intervention group will receive a treatment of tSMS in the primary motor cortex.
15752802|NCT04836325|Procedure|Sham transcranial static magnetic field stimulation|The placebo group will receive a dummy treatment
15752803|NCT04836312|Behavioral|Soft Commitment Device|Patients randomized to the commitment device arm will be asked to visit the Way to Health platform. There, they will identify a support person, a family or friend who they speak to frequently and who is invested in their health. They will then complete a series of questions intended to create implementation intentions. Specifically, they will pick a time for their fast to begin each 24-hour period and a time for their fast to end. They will also develop strategies to deal with hunger arising during a fast period. After this process, they will sign a contract pledging to adhere to the 16:8 time-restricted feeding dietary pattern, and acknowledging that their support person will receive a copy of the contract and weekly updates about their adherence to the regimen.
15752804|NCT04836299|Drug|Ivermectin|Participants will be randomly assigned to receive a single 600 µg / kg dose of ivermectin or placebo.
15752805|NCT04836299|Drug|Placebo|Participants will be randomly assigned to receive a single of placebo.
15752806|NCT04836286|Behavioral|Emotive Intelligent Spaces (EIS)|The EIS leverages innovations across multiple disciplines, including sensory environment, computer science, psychology, and real-time human-computer interface. The colors of the LED lights on the EIS wooden panels are controlled by an artificial intelligence computer algorithm that will translate children's physiological responses (Galvanic skin response, body temperature, and blood volume pulse), captured by a digital wristband, into their emotional state and the associated preferred colored lighting. The algorithm was created in a co-investigator's published study11, using fuzzy logic and machine learning techniques (i.e., Decision Tree; accuracy 86%).To successfully carry out this project, our team blends expertise in educational psychology, early intervention, computer science, architecture, and interior design.
15752807|NCT04836273|Drug|Dasiglucagon|Abdominal s.c. self-administration 120 µg of dasiglucagon when blood glucose levels are below 3.9 mmol/L or interstitial glucose levels below 3.5 mmol/L. The frequency of the intervention is approximately once a day.
15752808|NCT04836273|Device|HyoPen|multi-dose reusable pen injector
15752809|NCT04836273|Drug|Placebo|Abdominal s.c. self-administration with placebo when blood glucose levels are below 3.9 mmol/L or interstitial glucose levels below 3.5 mmol/L. The frequency of the intervention is approximately once a day.
15752810|NCT04836260|Drug|SARS-CoV-2 convalescent plasma|Included patients will receive at least one unit of convalescent plasma with NTAB titer ≥1:160 at maximum 3-7 days after diagnosis by RT-PCR or symptom onset. A second unit of plasma from a different donor can be proposed 24h after the first unit if immunocompromised and/or the patient received less than 3-5ml/kg of plasma volume. Additional units can be exceptionnally infused, at the investigator discretion.
15752813|NCT04836234|Other|Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum|Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum 65g 40 pieces
15752814|NCT04836221|Behavioral|Support|"Community Health Workers will conduct weekly phone calls to monitor blood pressure or blood glucose, to check in on patient need for social, practical or emotional supports, and to encourage healthy lifestyle modification.
~Participants will also have access to a mobile app to support chronic disease management (Either diabetes or hypertension)."
15752876|NCT04835701|Behavioral|Music|Music may be played through a portable speaker in close proximity to the patient or through the patient's own headphones, if preferred. Music will be played at a low enough volume for subjects to hear standard anticipatory guidance during the procedure.
15752877|NCT04835688|Procedure|Transmyringeal ventilation tube insertion|"In both groups, the tympanic membrane will be anesthetized by local application of topical prilocaine (EMLA) or phenol or by infiltration anaesthesia of the outer ear canal. The choice of method is left to the discretion of the surgeon.
~For the experimental group, insertion of a ventilation tube will be performed. An incision is performed, usually in the lower, anterior quadrant of the tympanic membrane and the transmyringeal tube is inserted."
15752815|NCT04836195|Drug|PCLX-001 treated|"To ensure maximal safety in this first-in-human trial, the starting dose level was chosen to be 20 mg daily. PCLX-001 will be provided as an oral flat daily dose on a 28-day cycle. Missed doses for any reason will not be administered at a later time.
~The Dose-Escalation phase will follow a standard 3+3 cohort design. Three patients will be treated at each dose level. If 0/3 patients experience DLT, 3 patients will be treated at the next dose level. If DLT attributable to the treatment is experienced in 1/3 patients, three more patients (for a total of six patients) will be treated at that dose level. If no additional DLT is observed at the expanded dose level (i.e. 1/6 with DLT), the dose will be escalated. Escalation will terminate as soon as two or more patients experience any DLT attributable to study drugs, at a given dose level. DLT and determination of MTD will be based on cycle 1 toxicities."
15752816|NCT04836182|Drug|IONIS-AGT-LRx|Multiple doses of IONIS-AGT-LRx will be administered by SC injection.
15752817|NCT04836182|Drug|Placebo|IONIS-AGT-LRx-matching placebo will be administered by SC injection.
15752818|NCT04836169|Device|InCaveo's EOA system with integrated mobile CBT|integrated pain management therapeutic and tapering system including a software apt that manages and tracks patient-reported outcomes, including pain levels, medication use, quality of life
15752819|NCT04836156|Drug|neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screening for triple negative breast cancer|The choice of chemotherapy is based on the PTC drug sensitivity results.
15752820|NCT04836156|Drug|neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screening for luminal like breast cancer|The choice of chemotherapy is based on the PTC drug sensitivity results.
15752821|NCT04836143|Drug|Intravitreal anti-vascular endothelial growth factor injection|Intravitreal injection of either ranibizumab or aflibercept
15752822|NCT04836130|Procedure|patient specific guide|patient specific guide reduction
15752823|NCT04836130|Procedure|conventional technique|conventional anatomical reduction
15752824|NCT04836117|Other|SomaSignal Test Results|SomaLogic, Inc. translates patterns from 5000 protein measurements made in thousands of participants in clinical trials into validated models (SomaSignal Tests) that predict important health outcomes or correlate with established health measures. SomaLogic, Inc. has developed these protein-based tests for the detection, subtyping and prognosis of heart disease and related medical, physiological and behavioral conditions. These tests are demonstrated in large retrospective studies to provide information superior to best available alternatives.
15752825|NCT04836091|Behavioral|Waitlist|From day 31 to day 60 (ie., during month 2) of the trial, participants in the waitlist arm will be granted access and instructed to use the OurPlan program as directed. The OurPlan program includes 4 modules covering topics of communication, HIV/STI prevention, HIV/STI statistics, and stigma / discrimination. Each module contains content, questions, and an activity for the participant and couple to complete. OurPlan also includes a resource locator using GPS-capabilities to allow participants to find sexual health resources, as well as a calendar and reminder system. One goal of OurPlan is to help both partners of the couple create and use a risk-reduction plan of evidence-based prevention strategies over time. Answers provided during the assessments will help determine whether participants/couples created a risk-reduction plan and used evidence-based strategies over time, including changes in their own and partner-related attitudes toward these strategies.
15752826|NCT04836091|Behavioral|Intervention|From day 1 to day 60 (ie., entire 2 month duration) of the trial, participants in the intervention arm will be granted access and instructed to use the OurPlan program as directed. The OurPlan program includes 4 modules covering topics of communication, HIV/STI prevention, HIV/STI statistics, and stigma / discrimination. Each module contains content, questions, and an activity for the participant and couple to complete. OurPlan also includes a resource locator using GPS-capabilities to allow participants to find sexual health resources, as well as a calendar and reminder system. One goal of OurPlan is to help both partners of the couple create and use a risk-reduction plan of evidence-based prevention strategies over time. Answers provided during the assessments will help determine whether participants/couples created a risk-reduction plan and used evidence-based strategies over time, including changes in their own and partner-related attitudes toward these strategies.
15752827|NCT04836078|Procedure|open flap subgingival debridement|After the reevaluation phase after that corrective surgical phase started for the three groups. Local infiltration anesthesia administrated then sulcular flaps raised for the purpose of open flap subgingival debridement.Randomization was then performed and concealment from the assessors.
15752828|NCT04836078|Procedure|Subgingival injection of chitosan 2% gel|Group (I); injected subgingivally with chitosan 2% gel containing a microsponges formulated drug weekly
15752829|NCT04836078|Procedure|Subgingival injection of chitosan 2% gel|Group (II); injected subgingivally with chitosan 2% gel containing free drug weekly
15752830|NCT04836078|Procedure|Subgingival injection of chitosan 2% gel|Group (III); injected subgingivally with placebo chitosan 2% gel weekly
15752831|NCT04836052|Drug|Omega 3 fatty acid|omega-3-oil 2 gm twice daily PO/NGT/OGT for 28 days or ICU discharge or death.
15752832|NCT04836039|Other|A questionnaire and scales.|Participants will be evaluated by applying a questionnaire and scales created by the researcher physiotherapists based on the researches and examples in the literature.
15752833|NCT04836026|Device|HF20™|HF20™ will be used for CRRT
15752834|NCT04836013|Dietary Supplement|combined Lactobacilli|1 oral stick per day for 30 days starting the day of antibiotic treatment
15752835|NCT04836013|Other|Placebo|1 oral stick per day for 30 days starting the day of antibiotic treatment
15752836|NCT04836000|Other|In addition to the conservative treatment, Low-level laser therapy|"For Experimental Group A Gallium-aluminum-arsenide (Ga-Al-As) diode laser instrument (Roland Serie, Elettronica Pagani, Paderno, Italy, Mod IR 27/1) will be used (wavelength 904 nm, 5500 Hz frequency, 27 W maximum power output per pulse, 13.2 mW average power, 0.8-cm2 spot size, 1.6 J of total energy will be delivered per point at each session at a power density of 16.5 mW/cm2, and the cumulative energy per point for all sessions was 16 J).
~Ga-Al-As laser therapy will be applied to experimental group patients two times per week for 12 weeks in 10-min sessions. LLLT will be applied over the tuberculum majus and minus, the anterior and posterior faces of the capsule, and the subacromial regions. Each point will be treated for 120 sec. The head of the instrument will be held perpendicular to the body surface and in skin contact without pressure."
15752903|NCT04835428|Device|Control Group: PMMA bone cement|High viscosity PMMA bone cement will be used for vertebral augmentation.
15754888|NCT04818632|Drug|AZD9833 with palbociclib|Part B: AZD9833 with palbociclib dose expansion
15752838|NCT04836000|Other|Conservative treatment solely|For Control Group The rehabilitation program for the 3 groups will be equal and consist of 3 phases.Each phase contains several recommended exercises from which the physiotherapist can choose, with respect to restrictions. The physiotherapist decides when the patient is ready to move on to the next phase, considering aspects of quality of motion and pain. Phase 1 includes standardized information about the condition and exercises aimed at promoting good posture and stabilization of the scapula. Initially, range of motion exercises that unload the rotator cuff will be used, such as the wall slide and supported active flexion on a table using a ball and active assisted exercises in elevation, abduction, and external rotation. Phase 2 contains active unloaded exercises in elevation, external, and internal rotation as well as isometric strengthening exercises. Phase 3 includes dynamic strengthening exercises for the rotator cuff and scapula stabilizers.
15752839|NCT04835987|Diagnostic Test|Holter ECG|Measurement of the modification of the sympathomimetic balance
15752840|NCT04835987|Behavioral|Questionary|Lifestyle questionary (time spent in front of television, physical activity)
15752841|NCT04835987|Diagnostic Test|Pupillometry|Monitoring of nociception and autonomic nervous system by pupillometry in intraoperative.
15752842|NCT04835974|Diagnostic Test|"1- LDL-C (low-density lipoprotein cholesterol)| and HDL-C(high-density lipoprotein cholesterol) Ratio. 2- Glycemia will be assessed : RBS ( random blood sugar ) . 3- S"|"Blood samples were obtained before PCI, and the following parameters will be measured:
~LDL-C (low-density lipoprotein cholesterol)| and HDL-C(high-density lipoprotein cholesterol) Ratio.
~Glycemia will be assessed : RBS ( random blood sugar ) .
~Serum Uric acid : S .UA"
15752843|NCT04835961|Other|Maintenace and As needed|This study will record the use of budesonide / formoterol either as maintenance treatment or / or as needed according to standard clinical practice and at the discretion of the treating physician.
15752844|NCT04835948|Drug|single dose of Anti-thymocyte globulin|Used anti-thymocyte globulin (ATG) in a single dose of 3 mg/kg for immunosuppression induction in the immediate postoperative period
15752845|NCT04835935|Other|microbiome pattern|microbiome pattern in neonatal period
15752846|NCT04835922|Procedure|Intercostal Nerve Block|: Following PCNL Intercostal nerve block will be given at 11th and 12th Intercostal space on the side of surgery with 20cc of 0.25% bupivacaine under fluoroscopy guidance in prone position lateral to mid scapular line by Urologists. The 23 G spinal needle tip will be used and located above the innermost intercostal muscle. The needle tip will be located above the innermost intercostal muscle. In the next step, following negative aspiration for blood, 20 ml of 0.25% bupivacaine will be injected into the intercostal space between innermost intercostal muscle and pleura below 11th, and 12th ribs (10 ml each)
15752847|NCT04835922|Procedure|Peritract Infiltration|At the end of PCNL a single dose of Peritract infiltration of 20cc of 0.25% bupivacaine will be given by Urologists. A 23 gauge spinal needle will be inserted up to the renal capsule along the nephrostomy tract at 6 and 12 o'clock (10ml at each position) under fluoroscopic guidance, 0.25 % bupivacaine will be infiltrated into the nephrostomy tract from renal capsule to the skin area (10 ml for each position).
15752848|NCT04835909|Behavioral|Modern board and card games group|Modern board and card games group
15752849|NCT04835909|Behavioral|Paper and pencil tasks group|Paper and pencil tasks group
15752850|NCT04835896|Drug|M7824+paclitaxel|M7824 will be administered intravenously at a dose of 1200 mg every 3 weeks in combination with paclitaxel 80 (or 70) mg/m2 once a week for 3 weeks (each cycle is 4 weeks)
15752851|NCT04835883|Biological|CS20AT04 (allogenic bone marrow derived mesenchymal stem cell)|Two intravenous infusions of CS20AT04 (2.0×10^6cell/kg), on 0 day and on 12 weeks The target population of this study is subjects in South Korea with a diagnosis of either lupus nephritis or lupus cytopenia.
15752852|NCT04835870|Drug|Zanubrutinib|Zanubrutinib-160mg bid PO d0-d20(1-21d)
15752853|NCT04835870|Drug|Rituximab|Rituximab-375 mg/m2 i.v d0 (/21d)
15752854|NCT04835870|Drug|Cyclophosphamide|Cyclophosphamide-750 mg/m2 i.v d1 (/21d)
15752855|NCT04835870|Drug|Doxorubicin|Doxorubicin-50 mg/m2 i.v d1 (/21d)
15752856|NCT04835870|Drug|Vincristine|Vincristine-1.4 mg/m2 i.v d1 (/21d)(2 mg max)
15752857|NCT04835870|Drug|Prednisone|Prednisone-100 mg p.o d1-d5 (/21d)
15752858|NCT04835857|Device|ViTrack|ViTrack is a continuous non-invasive wearable blood pressure cuff.
15752859|NCT04835857|Device|Oscillometric BP Device|Oscillometric blood pressure measurement is the standard of care for measuring blood pressure in outpatient / home settings.
15752860|NCT04835857|Device|Auscultatory cuff|The auscultatory method is the gold standard for clinical blood pressure measurement. A brachial cuff is mounted and a trained healthcare provider uses a sphygmomanometer and listens for the Korotkoff sounds using a stethoscope to measure blood pressure.
15752861|NCT04835844|Device|CARTO|Redo-ablation of paroxysmal AF with high density mapping system, CARTO, in conjunction with CONFIDENSE mapping module and PENTARRAY catheter
15752862|NCT04835844|Device|RHYTHMIA|Redo-ablation of paroxysmal AF with high density mapping system, RHYTHMIA, in conjunction with the 64-electrodes ORION mini-basket catheter.
15752863|NCT04835831|Other|adapted physical activity + Dietetic advice|adapted physical activity during 24 weeks
15752864|NCT04835818|Diagnostic Test|Provide the panel report to the primary care physician|Point-of-care Multiplex PCR Respiratory Panel (BIOFIRE FilmArray) and Pneumonia Panel results (BIOFIRE FilmArray)
15752865|NCT04835805|Drug|Belvarafenib|Twice daily (BID), continuous dosing
15752866|NCT04835805|Drug|Cobimetinib|Once daily (QD) 21 days, 7 days off
15752867|NCT04835805|Drug|Atezolizumab|Once every 4 weeks (Q4W)
15752868|NCT04835792|Other|Stool and blood collection|One-time stool and blood collection
15752869|NCT04835766|Diagnostic Test|Urodynamic study|Uroflowmetry, voiding cystometrogram, maximum flow rate (Qmax) and detrusor pressure at maximum flow (Pdet Qmax).
15752870|NCT04835753|Device|shock wave|true radial ESWT.A rESW pneumatic device (SHOCK MED, Italy) was used to provide one session per week (for a total of 12-week)
15752871|NCT04835753|Other|traditional physical therapy program|lower limbs muscles stretch and strength in addition to balance and gait training
15752872|NCT04835740|Other|High intensity Interval Training|All the participants underwent 5 weeks of High intensity interval training.
15752873|NCT04835727|Other|Semi-vegetarian diet and increase fiber consumption|All patients in this study will be advised by an experienced nutritionist to intake high fiber diets with a low intake of red meat and processed food.
15752878|NCT04835688|Procedure|Sham-treatment|For the control group, the ENT-specialist will touch the tympanic membrane with an alligator ear forceps to simulate getting a paracentesis. In the same procedure, without having made a paracentesis, a ventilation tube is placed on the tympanic membrane and removed again afterwards. The reason for the above-mentioned is to simulate getting a paracentesis and insertion of a ventilation tube.
15752879|NCT04835675|Device|Multi-cancer early detection test|Blood collection and multi-cancer early detection testing
15752880|NCT04835662|Behavioral|Complementary feeding promotion|The intervention engaged fathers through community meetings, religious services, and mobile phone text and voice messages. Mothers received home visits from community health extension workers (CHEWs), which fathers also could attend. Social behavior change communication materials included TV and radio messages, sermon guides, counseling cards, pamphlets, posters, and feeding bowls.
15752881|NCT04835649|Other|Exercise|Both groups will receive exercise-based training
15752882|NCT04835636|Behavioral|Diabetes Prevention Program|This program is a 1 year lifestyle modification program focused on reducing calories and fat calories and increasing physical activity to achieve a 7% weight loss. This study utilized the first 16 sessions (6 months) of the program
15752883|NCT04835623|Drug|Cyclosporine 0.09% Ophthalmic Solution|one drop each eye twice daily
15752884|NCT04835610|Device|pvi|The Plethysmographic Variability Index (PVI) can be measured with both finger and forehead probes. Vasoconstriction may reduce the reliability of PVI measurements in pediatric surgical patients prone to hypothermia. The vascular structure of the forehead area is resistant to changes in vasomotor tonus. The aim of our study is to compare the efficacy of PVI values measured at the finger and forehead areas to predict fluid responsiveness in these patients.
15752885|NCT04835597|Behavioral|Behavioral Assessment|Complete movement assessment
15752886|NCT04835597|Other|Electronic Health Record Review|SAE data is collected
15752887|NCT04835584|Drug|KRT-232|KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth.
15752888|NCT04835584|Drug|Dasatinib|Dasatinib is a Tyrosine Kinase Inhibitor anticancer drug taken by mouth.
15752889|NCT04835584|Drug|Nilotinib|Nilotinib is an Tyrosine Kinase Inhibitor anticancer drug taken by mouth.
15752890|NCT04835571|Other|Optimization of cardiovascular risk management|"Treatment goals were set according to current guidelines (Perk et al. Eur Guidelines on CVD prevention in clinical practice (2012). Eur heart J. 2012;33(13):1635-701):
~blood pressure <140/90 mmHg
~Tot cholesterol <5 mmol/l
~LDL <1,8 mmol/l
~Waist circumference: men <94 cm, women <80 cm
~BMI <25 kg/m2
~HbA1c without diabetes mellitus <42 mmol/mol, HbA1c with diabetes mellitus <52 mmol/mol
~Antithrombotic treatment (or anticoagulants, if indicated)
~Physical activity 30 min/day, 5 days/week, alternatively high-intensity training at least15 min/day, 5 days/week or a combination of the two.
~Healthy diet, including low levels of saturated fats, high intake of vegetables, fruits, whole-grain and fish
~Smoking cessation
~Low alcohol consumption
~Patients were encouraged to follow the above recommendations through support of the study physicians, who made individual assessments of all patients and adjusted ongoing medical treatment to reach treatment targets."
15752891|NCT04835545|Other|extreme hypercapnia induced by ventilation insufficiency|extreme hypercapnia
15752892|NCT04835532|Procedure|guided bone gereration|"guided bone generation: GBR is a procedure that uses barrier membranes with or without particulate bone grafts or/and bone substitutes.
~tenting screws: Screws are implanted in the surgical area to prevent the barrier membrane from collapsing.
~A-PRF/I-PRF: Obtained by autologous blood centrifugation."
15752893|NCT04835519|Biological|chimeric antigen receptor T cell|Subjects will be pretreated with chemotherapy prior to infusion of CAR T cells: about 5 days before cells transfusion, the patients who planned to reinfuse CAR T cells were treated with fluorodarabine 30 mg/m^2( body surface area) and cyclophosphamide 250 mg/m^2( body surface area) for 3 days. Then this study will be using the Bayesian optimal interval phase I/II (Boin12) trial design. The protocol preset 2 dose levels: Dose 1 (DL-1) was 5×10^5 (±20%) CAR T cells/kg, and dose 2 (DL-2) was 1×10^6 (±20%) CAR T cells/kg. If the above dose cannot be met, subjects can still enter the study upon investigator consideration but require documentation of dosing. The lowest dose is 1×10^5 CAR T cells/kg (±20%), and the highest dose is 1×10^6 CAR T cells/kg (±20%). If the dose is out of the range mentioned above, entry into the trial will not be considered.
15752894|NCT04835506|Drug|Infliximab|infliximab using iDose to generate dosing
15752895|NCT04835493|Other|Intervention|In the proposed study, we will conduct a randomized clinical trial of low-income, adult Latino(a)s with type 2 diabetes randomized at the individual level to TIME (Telehealth-supported, Integrated CHWs, Medication-access, group visit Education) (intervention) versus usual care enhanced with education (EUC). Our research team will provide telementoring to local clinic teams (providers and CHWs) to initiate the 12-month TIME program into their clinics.
15752896|NCT04835480|Drug|OrsHSA|OsrHSA a recombinant HSA, which was expressed and purified from the plant Oryza sativa
15752897|NCT04835480|Drug|HSA|Albutein® 20% (ALBUMIN HUMAN INFUSION 20% 50ML)
15752898|NCT04835467|Device|Dual-modal OCT-FLIm|Intracoronary imaging using dual-modal OCT-FLIm catheter
15752899|NCT04835454|Diagnostic Test|piRNAs, miRNA-194, regucalcin and plasma aminoacids levels|PIWI-interacting RNAs (piRNAs), a class of small nuclear RNA molecules, are associated with the PIWI proteins. MicroRNAs (miRNAs) are conserved small non-coding RNAs (19-22 nucleotide-long) that mediate post-transcriptional regulation of gene expression, affecting mRNA stability and translation by binding complementary sites on target mRNAs. Regucalcin (RGN) is an inhibitory protein of calcium signaling with calcium-binding properties. It plays a multifunctional role in the regulation of cell functions, including maintenance of intracellular calcium homeostasis, inhibitions of protein kinases and protein phosphatases linked to cell signaling process, suppressions of protein production and nuclear DNA and RNA synthesis.Free amino acids, in biological fluids can be a reduced invasive method associated to a high diagnostic potential. It was found that free amino acid profiles vary depending on type of cancer and its stage.
15752902|NCT04835428|Device|Treatment Group: AGN1 LOEP SV Kit|The AGN1 LOEP SV Kit is intended for fixation of pathological fractures of the vertebral body using vertebral augmentation. Following saline lavage to create space, the AGN1 implant material is injected and hardens in situ to augment the fractured vertebral body. The AGN1 implant material is then resorbed and replaced with new bone.
15752904|NCT04835415|Procedure|Bilateral retrolaminar block|in lateral position and after skin sterilization. The spine is palpated from cervical (C7) downward toT8 and point marked to identify the spinous process. The linear high frequency transducer (6-13 MHz) will be placed 1 cm lateral to the midline. The needle (18-22 gauge) is inserted in the plane view of the ultrasound probe to target the T8 and needle is advanced at an angle of 90˚ to the skin until the needle tip contacted the lamina (6). After negative aspiration, a 20 ml of bupivacaine 0.25 % plus 5ug/ml adrenaline (1:200000) will be injected. The procedure will be repeated following the same steps on the other side.
15752905|NCT04835415|Procedure|Thoracic epidural analgesia|In the lateral position, after skin sterilization, Ultrasound with high frequency linear probe (5-13 MHz). Thoracic intervertebral space (T8-9) will be identified by counting from the most prominent thoracic spine (T7). The probe will be used in parasagittal plane 2 cm from midline. The probe will be directed medially to identify the dura matter at the T8-9 intervertebral space
15752906|NCT04835402|Drug|Pembrolizumab|400mg every 6 weeks
15752907|NCT04835402|Device|Irreversible electroporation|Percutaneous ablation of one liver metastasis
15752908|NCT04835389|Biological|AlloGen Liquid|Amniotic fluid
15752909|NCT04835389|Drug|Placebo|0.9% normal saline
15752910|NCT04835376|Device|Percussion Palm Cup: Safety and Usability of Newly Designed Products in Infants and Children with Cystic Fibrosis|Patients/guardians/caregivers will be given 3 percussor palm cups to use over the course of 6 days. Each cup will be trialed for 2 days, allowing for equal time dedicated to each.
15752911|NCT04835363|Other|Early Occupational Therapy intervention|four-week OT intervention program with the support of the main caregiver in patients who have suffered a stroke with the aim of improving the functional result and facilitating the return home by providing knowledge to the caregiver about specific care and neurorehabilitation.
15752912|NCT04835350|Device|Pancreas4ALL - meal announcement or full closed loop|Patient using AID Pancreas4ALL in mode meal announcment or full closed loop.
15752913|NCT04835337|Behavioral|Air Purifiers|Students are divided into two groups: intervention group and control group. The intervention team places an air purifier in the indoor environment to intervene. All the indoor environment of the group use the same qualified air purifier, and all participants and research staffs are blinded to the group assignment.
15752914|NCT04835337|Behavioral|Sham Air Purifiers|The control group is also intervened. The intervention is to place a sham air purifier (remove the filter screen) in the indoor environment, and all the indoor environment use the same air purifier as the intervention group. All participants and research staffs are blinded to the group assignment.
15752915|NCT04835311|Procedure|surgical perineal repair|women who have undergone surgical perineal repair (codes CCAM JMMA002 and/or HKCA005)
15752916|NCT04835298|Other|Dyspnea|questionnaires
15752917|NCT04835285|Diagnostic Test|Npf.|3T MRI and 1,5 T MRI scanners. For myocardium, pancreas and pituitary gland iron overload
15752919|NCT04835259|Drug|Selenium Amino Acid Chelate (Selenium ACE cream)|application of a topical agent over the whole face for 6 months
15752920|NCT04835246|Device|Spectra IMDx system|The Spectra IMDx system is intended to be used in conjunction with conventional white light endoscopy in upper gastrointestinal endoscopic procedure to identify patients with high risk of developing and/or having gastric cancer and it is intended for use on patients above and equal to the age of 18.
15752921|NCT04835233|Drug|Methyldopa 250 MG|maintaining postpartum the use of methyldopa 250 mg 01 tablet every 8 hours, being able to double the dose depending on pressure levels, up to 15 days postpartum
15752922|NCT04835220|Other|Telehealth Calls|The telehealth nurse will record data in a case report form within the VA REDCap electronic data capture system that is stored within the VA firewall.
15752923|NCT04835207|Other|"1- LDL-C (low-density lipoprotein cholesterol)| and HDL-C(high-density lipoprotein cholesterol) Ratio. 2- Glycemia will be assessed : RBS ( random blood sugar ) . 3- S"|"Blood samples were obtained before PCI, and the following parameters will be measured: 1- LDL-C (low-density lipoprotein cholesterol)| and HDL-C(high-density lipoprotein cholesterol) Ratio. 2- Glycemia will be assessed : RBS ( random blood sugar ) . 3- S"
15752924|NCT04835181|Behavioral|Electroacupuncture combined with umbilical moxibustion|"①Umbilical moxibustion intervention: point selection: Shenque point Operation: Place the aconite cake on the Shenque point, place the Aizhu in the middle of the aconite cake, ignite the Aizhu and apply moxibustion to make the local warm sensation without burning pain, until the skin is flushed.
~②Electro-acupuncture intervention: Acupoint selection: Tianshu, Zusanli, Zhongwan, Moisture, Daheng, Vein, Waterway, Huaroumen, Abdominal Knot.
~Operation: supine position, routine skin disinfection. After routine acupuncture at the acupoints, apply the technique of flattening, replenishing, relieving, and relieving qi. Tianshu and Daheng points, respectively, were horizontally connected to the electrodes of the electroacupuncture instrument on the needle handles of the bilateral Tianshu and Daheng points.
~Electroacupuncture parameters: density wave, current intensity 1-5mA, electroacupuncture intensity is subject to patient tolerance."
15752925|NCT04835181|Behavioral|Electroacupuncture|"②Electro-acupuncture intervention: Acupoint selection: Tianshu, Zusanli, Zhongwan, Moisture, Daheng, Vein, Waterway, Huaroumen, Abdominal Knot.
~Operation: supine position, routine skin disinfection. After routine acupuncture at the acupoints, apply the technique of flattening, replenishing, relieving, and relieving qi. Tianshu and Daheng points, respectively, were horizontally connected to the electrodes of the electroacupuncture instrument on the needle handles of the bilateral Tianshu and Daheng points.
~Electroacupuncture parameters: density wave, current intensity 1-5mA, electroacupuncture intensity is subject to patient tolerance."
15752926|NCT04835168|Drug|BT-11 500mg|Subjects will be randomized (1:1:1) to receive BT-11 1000 mg once daily, BT-11 500 mg twice daily, or placebo twice daily for 12 weeks. All tablets administered (placebo and BT-11) will have the same appearance and size. Each subject will receive tubes containing the study drug (BT-11 1000 mg, BT-11 500 mg, or placebo).
15752927|NCT04835168|Drug|BT-11 1000mg|Subjects will be randomized (1:1:1) to receive BT-11 1000 mg once daily, BT-11 500 mg twice daily, or placebo twice daily for 12 weeks. All tablets administered (placebo and BT-11) will have the same appearance and size. Each subject will receive tubes containing the study drug (BT-11 1000 mg, BT-11 500 mg, or placebo).
15752928|NCT04835168|Drug|BT-11 Placebo|Subjects will be randomized (1:1:1) to receive BT-11 1000 mg once daily, BT-11 500 mg twice daily, or placebo twice daily for 12 weeks. All tablets administered (placebo and BT-11) will have the same appearance and size. Each subject will receive tubes containing the study drug (BT-11 1000 mg, BT-11 500 mg, or placebo).
15752929|NCT04835155|Procedure|Premature Infant Oral Motor Intervention (PIOMI)|The Premature Infant Oral Motor Intervention (PIOMI), developed by Dr. Brenda Lessen Knoll, was chosen for this study because it is the only oral motor program designed specifically for preterm babies as young as 29 weeks post menstrual age (PMA) and is the only program with a standardized training method and published intervention fidelity. The 5 minute therapy offers assisted movement to activate muscle contraction and movement against resistance to build strength in the perioral structures. The PIOMI has 8 steps where a provider uses a pinky finger to provide gentle stroking and pressure on the cheeks, lips, tongue, gums and palate to strengthen the oral sensory-motor functions and improve feeding efficiency. PIOMI ends with 2 minutes of NNS. NNS and oral stimulation have been found to mature the oral motor sensory system, and improve not only bottle feeding, but also breastfeeding.
15752930|NCT04835142|Drug|Double blind control period A140|experiment arm： Drug A140:400 mg/m2（D1，iv）,250 mg/m2（qw，iv） Drug Oxaliplatin 85 mg/m2（D1,iv), Drug Calcium Folinate 400 mg/m2（D1,iv） Drug 5-FU 400 mg/m2（D1,iv），2400 mg/m2 (48±4h) control arm: Drug Erbitux:400 mg/m2（D1，iv）,250 mg/m2（qw，iv） Drug Oxaliplatin 85 mg/m2（D1,iv) Drug Calcium Folinate 400 mg/m2（D1,iv） Drug 5-FU 400 mg/m2（D1,iv），2400 mg/m2 (48±4h)
15752931|NCT04835142|Drug|Open single period A140|Drug A140:400 mg/m2（D1，iv）,250 mg/m2（qw，iv） Drug Oxaliplatin 85 mg/m2（D1,iv), Drug Calcium Folinate 400 mg/m2（D1,iv） Drug 5-FU 400 mg/m2（D1,iv），2400 mg/m2 (48±4h)
15752932|NCT04835129|Drug|Isatuximab (for run-in portion)|10 mg/kg IV on days 2, 8, 15, 22 of cycle 2 and days 1 and 15 of subsequent cycles.
15752933|NCT04835129|Drug|Isatuximab (for expansion)|10 mg/kg IV on days 2, 8, 15, 22 of cycle 1 and days 1 and 15 of subsequent cycles.
15752934|NCT04835129|Drug|Pomalidomide|4 mg PO days 1-21 of each cycle.
15752935|NCT04835129|Drug|Elotuzumab|10 mg/kg on days 1, 8, 15, 22 of cycles 1 and 2; 20 mg/kg on day 1 of subsequent cycles.
15752936|NCT04835129|Drug|Dexamethasone|40 mg (20 mg if >75 years) PO or IV on days 1, 8,15 and 22 of each cycle.
15752937|NCT04835116|Drug|Bupivacaine Hydrochloride 0.25% Injection. Paracetamol 650mg. Orphenadrine 50mg.|Group A patients were administered per-operative peri tract local anesthesia infiltration with 0.25% bupivacaine augmented by post-operative oral analgesia with a combination of Paracetamol 650 mg and Orphenadrine 50mg 6 hourly.
15752938|NCT04835116|Drug|paracetamol 1000mg. Tramadol 50mg. Dimenhydrinate 50mg.|Group B patients were only given post-operative intra-venous analgesia by Paracetamol 1gm intravenous 8 hourly augmented with a combination of Tramadol 50mg and Dimenhydrinate 50mg as and when required
15752939|NCT04835103|Behavioral|CM|Case management, a case manager will actively contact and follow the patient's physical and psychological conditions, and provide disease-specific psychoeducation
15752940|NCT04835103|Behavioral|P/T|Psychotherapy, based on both cognitive-behavioral therapy and biofeedback therapy, structuralized, 6-10 sessions, performed by a psychiatrist or psychologist
15752941|NCT04835090|Other|screening test|using three screening tools
15752942|NCT04835077|Other|aerobic exercise|Structured aerobic exercises (Each session will consist of 50 minutes and will be divided into three parts: 5 minutes of warm-up exercises, 40 minutes of aerobic exercises, 5 minutes of cool down exercises) will be taught in the first session.
15752943|NCT04835077|Other|postural stabilization exercises|Structured postural stabilization exercises (strengthening exercises, balance-coordination exercises, flexibility exercises) will be taught in the first session.
15752944|NCT04835064|Drug|Nab paclitaxel|Albumin combined with paclitaxel 125mg/m2 intravenous infusion, Day 1, 8, 15
15752945|NCT04835064|Drug|Gemcitabine|Intravenous infusion of 1000 mg/m2 was given for more than 30min on days 1, 8, and 15, and repeated every 4 weeks
15752946|NCT04835064|Drug|mFOLFIRINOX|Oxaliplatin 85 mg/m2 intravenous infusion for 2 h, Day 1;LV 400 mg/m2 intravenous infusion for 2 h, Day 1;Irinotecan 150 mg/m2 was added 30 min after intravenous infusion for 90 min, day 1;This was immediately followed by a continuous intravenous infusion of 5-FU 2400 mg/m2 for 46 h.Repeat every 2 weeks.
15752947|NCT04835051|Behavioral|Breastfeeding promotion|The intervention included training of health workers in private health facilities to provide in-person breastfeeding counseling to pregnant women and women with a child <6 months during clinic visits. The health workers also offered a mobile phone support component for appointment reminders, breastfeeding SMS and WhatsApp messages, WhatsApp breastfeeding support groups, informational materials (posters and foldable pocket-sized cards), and family engagement activities. Breastfeeding-related mass media through television and radio spots was available state-wide, including to women in intervention and comparison facilities.
15752948|NCT04835038|Drug|Sodium Bicarbonate Ringer's Injection|Intraoperative fluid therapy performed with BRS (Sodium Bicarbonate Ringer's Injection)
15752949|NCT04835038|Drug|Sodium Lactated Ringer's Injection|Intraoperative fluid therapy performed with LRS (Sodium Lactated Ringer's Injection)
15752950|NCT04835025|Drug|PD-1/PD-L1 inhibitor|In non-small cell lung cancer, patients with brain metastases received radiotherapy for brain lesions and immunotherapy (including sequential and concurrent model). Those patients would enter the trial group; After patients experiencing PD in this group, follow-up treatment until tumor progression again or death
15752951|NCT04835012|Other|Medical debt forgiveness|A non-profit charity, RIP Medical Debt, bought and retired medical debt for individuals that were assigned to the treatment group.
15752952|NCT04834999|Other|Validation of questionnaires in Kinyarwanda|Four questionnaires, three self-report instruments (Medication Adherence Rating Scale, Internalized Stigma of Mental Illness Inventory - 9-item Version and the Mood Disorder Questionnaire) and one clinical interview (the Young Mania Rating Scale)
15752953|NCT04834986|Drug|Tislelizumab combined with Lenvatinib|"Pre-operation: Tislelizumab, 200mg, iv,d1,q3w, 2-4 cycles; Lenvatinib,8mg/kg,po,qd,d1-d84.
~Operation Postoperation: 4-8 weeks after surgery, Tislelizumab, 200mg, iv,d1,q3w; Lenvatinib,8mg/kg,po,qd, up to one year."
15752954|NCT04834973|Drug|tigilanol tiglate|"Single or multiple Intratumoural treatment of tigilanol tiglate at escalating doses of 0.6 mg/m2, 1.2 mg/m2 and 2.4 mg/m2.
~Tigilanol tiglate is a novel, short-chain diterpene ester in early clinical development for local treatment of a wide range of solid tumours."
15752956|NCT04834960|Other|Minimizing Missed Opportunities for Vaccination (MOV)|This bundle of interventions has four components that include: (1) Disseminate (vaccination awareness among healthcare providers and child caregivers); (2) Document (vaccination status); (3) Deploy (vaccines); and (4) Discharge (provide advice/referrals for catch-up and routine vaccinations).
15752957|NCT04834947|Procedure|prone position|Choice of prone positioning a patient is at the discretion of the anesthesia physician.
15752958|NCT04834921|Device|Ultraflux® EMiC®2|Ultraflux® EMiC®2-CVVHD runs in septic shock patients with AKI KDIGO 3 for 24 hours. and patients were randomised to start Ultraflux® EMiC®2-CVVHD in the first day or in the second day from the RRT start; more precisely, crossover randomized to sequence consists in Ultraflux® EMiC®2-CVVHD (first day)+ HFF-CVVHDF(second day) and HFF-CVVHDF (first day) + Ultraflux® EMiC®2-CVVHD (second day) for 48 h total without washout
15752959|NCT04834908|Biological|Equine COVID-19 Antiserum|Equine COVID-19 antiserum is a polyclonal antibody and it contains Equine COVID-19 immune globulin G.
15752960|NCT04834908|Drug|Standard of care|Standard of care for COVID 19 infection based on the current guidelines and institutional practice will be provided
15752961|NCT04834895|Other|mhealth exercise group|Participants were asked to perform 18 exercises specially prepared for neck pain in the M.ü Neck Exercises application according to the number of repetitions specified in the application.Participants will be asked to do home exercises 3 days a week for 6 weeks
15752962|NCT04834895|Other|brochure exercise group|Participants were asked to perform 18 exercises specially prepared for neck pain in the brochure according to the number of repetitions specified in the application.Participants will be asked to do home exercises 3 days a week for 6 weeks
15752963|NCT04834882|Other|Data collection (|online survey
15752964|NCT04834869|Biological|BNT162b2|Receiving either the first dose only or both doses of BNT162b2 vaccine (Pfizer-BioNTech COVID-19 Vaccine)
15752965|NCT04834869|Biological|mRNA-1273|Receiving either the first dose only or both doses of mRNA-1273 vaccine (Moderna COVID-19 Vaccine)
15752966|NCT04834869|Biological|AZD1222|Receiving either the first dose only or both doses of AZD1222 vaccine (AstraZeneca-Oxford University COVID-19 Vaccine)
15752967|NCT04834869|Biological|CoronaVac|Receiving either the first dose only or both doses of CoronaVac (Sinovac COVID-19 Vaccine)
15752968|NCT04834869|Biological|Sinopharm|Receiving either the first dose only or both doses of Sinopharm Vero Cell COVID-19 Vaccine
15752969|NCT04834869|Biological|Gam-COVID-Vac|Receiving either the first dose only or both doses of Gam-COVID-Vac (Sputnik V)
15752970|NCT04834869|Biological|JNJ-78436735|Receiving JNJ-78436735 (Janssen COVID-19 Vaccine)
15752971|NCT04834869|Biological|CVnCoV|Receiving either the first dose only or both doses of CVnCoV (CureVac COVID-19 vaccine)
15752972|NCT04834869|Biological|NVX-CoV2373|Receiving either the first dose only or both doses of NVX-CoV2373 (Novavax COVID-19 vaccine)
15752973|NCT04834869|Biological|BBV152|Receiving either the first dose only or both doses of BBV152 (Covaxin COVID-19 vaccine)
15752974|NCT04834856|Drug|ensovibep|The study will start with a low-dose cohort and after a safety review escalate to the higher dose cohort. One administration at day 1 by infusion.
15752975|NCT04834843|Other|Observational study, no intervention|Observational study, no intervention
15752976|NCT04834830|Diagnostic Test|Pleural effusion will be examined for various cytokines and PD1-lymphocytes.|Examination of pleural effusion
15752977|NCT04834817|Device|Celluma POD|A blue and near infrared handheld LED device
15752978|NCT04834804|Other|Physical activity|12 weeks of exercise training
15752979|NCT04834791|Drug|Letrozole 2.5mg|These patients were treated with letrozole (Femara®, Novartis New York, NY, USA) in a dose 2.5 mg (one tablet daily) orally began on the 3rd day to the 7th day of the cycle. If ovulation is not achieved dose is increased by 2.5 mg in next cycle till 3 cycles
15752980|NCT04834791|Drug|Gonadotropin|These patients were given urofollitropin (fostimon ®, IBSA, Lugano, Switzerland) in a dose of 75 IU/mL I.M from day 3rd to day 7th of the cycle beginning by one ampoule per day and the dose had been modulated according to response.
15752981|NCT04834778|Drug|HC-5404-FU|HC 5404-FU (hemi fumarate salt of HC 5404) is a novel, highly selective, and potent PERK inhibitor. Preclinical pharmacological studies demonstrated high specificity of HC 5404-FU to PERK and decreased viability of tumor cells. HC 5404-FU will be orally administered BID every day with food or within 30 minutes of completing a meal, starting at 25 mg, with doses escalating to 50, 100, and 200 mg BID as safety allows for each 3-week treatment cycle.
15752982|NCT04834765|Other|Mindfulness-based art therapy|The researchers developed a novel MBAT intervention consisting of 10 easily reproducible, clay-based MBAT directives, administered through an online platform delivery strategy. By developing an MBAT intervention that uses an online delivery strategy, the researchers realized it may have the potential of decreasing demands placed on counseling centers.
15752983|NCT04834765|Other|Art-only|The AO modules consist of an open-ended art-making exercise, with minimal direction. The AO intervention is designed as an 'art for art's sake' intervention with the focus on the art-making and less on outcome or product. Participants are asked to pull their ball of clay out and spend ten minutes creating a form from the clay to visually express their experience in the present moment.
15752984|NCT04834765|Other|Mindfulness-only|The MO modules consist of only the mindfulness practices from the ABM intervention. The participants to follow along with a five-minute light yoga sequence, where asanas (yoga postures) are cued with breath. Yoga, for the purposes of the study, is explicitly defined to participants as the unity of breath with body movement. Poses were chosen based on their accessibility to a variety of body types and abilities, and chosen because they are documented to aid in grounding, increased haptic awareness, lowered levels of stress and anxiety, and restoration.
15752985|NCT04834752|Other|No intervention (Retrospective Cohort Observational)|History of PPI and H2RA prescription of the participants who were tested for COVID-19 will be reviewed.
15752986|NCT04834739|Other|6 minute walk test|The 6 Minute Walk Test is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity. 30 m long corridor is used for this test .
15753039|NCT04834362|Drug|Human insulin|Patients treated with human insulin regimen will receive 50% of total daily dose as NPH insulin at around 6 am and 6 pm, while the rest 50% regular human insulin three times a day in 3 equally divided doses at around 6 am, 12 pm and 6 pm.
15793780|NCT04502329|Other|Diet|Energy Restriction Intermittent Fasting Diet
15752987|NCT04834739|Other|1 minute Sit to Stand Test|The 1-minute STS test is performed with a chair of standard height of 46 cm without arm rests. The patient should be ensured to be seated upright on the chair positioned against a wall. The patient sat with the knees and hips flexed to 90°, feet placed flat on the floor hip-width apart, and the hands placed on the hips.The number of repetitions is measured.
15752988|NCT04834739|Other|Fatigue Severity Scale|The Fatigue Severity Scale is a 9-item scale which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders
15752989|NCT04834739|Other|Medical Research Council (MRC) dyspnea scale|"The MRC dyspnea scale is a questionnaire that consists of five statements about perceived breathlessness: grade 1, I only get breathless with strenuous exercise; grade 2, I get short of breath when hurrying on the level or up a slight hill; grade 3, I walk slower than people of the same age on the level because of breathlessness or have to stop for breath when walking at my own pace on the level; grade 4, I stop for breath after walking 100 yards or after a few minutes on the level; grade 5,  I am too breathless to leave the house."
15752990|NCT04834739|Other|SF-12|The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.
15752991|NCT04834739|Other|Beck Depression Inventory|The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression
15752992|NCT04834739|Other|Beck Anxiety Inventory|Beck Anxiety Scale is a 21-item, internationally valid, self-report rating inventory that measures the anxiety level.
15752993|NCT04834739|Other|5 times sit to stand test|The 5XSST scoring is based on the amount of time (to the nearest decimal in seconds) a patient is able to transfer from a seated to a standing position and back to sitting five times. The equipment need in performing 5XSST test includes: Stopwatch and standard height chair with straight back (43-45 cm, 17-18 inches high). Then the instruction is given by asking the test taker to sit on the chair by resting their back. Also, the test taker is instructed to fold their arms across their chest. Then the test taker should be instructed to do sit-to-stand five times, as quickly as possible, at the count of go and without their back or leg resting on the chair between the interval of repetition.
15752994|NCT04834739|Other|6 point Likert Scale|"Job performance was assessed by asking How do you evaluate your job performance? on 6-point Likert scale.A 6 point likert scale forces choice and gives better data.The 6 point Likert scale offers options for ''Excellent, very good, good, fair, poor and very poor''. 6 point scale anges from 1(very poor) to 5 (excellent)."
15752995|NCT04834726|Behavioral|Opt-In (Call-Back)|Messaging will include a prompt to agree to scheduling. If patient agrees, the access center will call these patients back to schedule, calling up to 3 times.
15752996|NCT04834726|Behavioral|Opt-in (In-Bound)|Messaging will include a prompt to agree to scheduling followed by a prompt to call the Penn Medicine Vaccine Scheduling Hotline to schedule their vaccine appointment.
15752997|NCT04834726|Behavioral|Standard Message|The message describes that the patient is eligible for the COVID vaccine.
15752998|NCT04834726|Behavioral|Clinician Endorsement|The message will describe an endorsement from the provider to get the vaccination.
15752999|NCT04834726|Behavioral|Scarcity|The message will highlight the limited availability and the elevated priority for the patient to receive the vaccine at Penn Medicine.
15753000|NCT04834726|Behavioral|Opt-Out Framing|This will highlight that a vaccine is reserved for the patient, implying that they need to opt-out.
15753001|NCT04834726|Behavioral|Phone Call|The access center will call these patients to schedule their vaccine appointment. These patients will not receive text messaging.
15753002|NCT04834713|Other|clinical classification of HFRS|Based upon clinical classification of HFRS , the patients were classified into four types
15753003|NCT04834700|Other|online group|In terms of teaching ultrasound, video lectures will be conducted rather than hands-on, which is the traditional method.
15753004|NCT04834687|Behavioral|Exercise|Rope-skipping exercise for three times a week (90 minutes each time, and there is a 10 min break after 20 min Rope skipping). Exercise bracelet and smart bracelet would be used to record the energy consumption throughout the study.
15753005|NCT04834687|Behavioral|Diet|"Diet interventions include ten-hour time-restricted eating and a high-fiber diet.
~Participants will be instructed to take food from 7:30 AM until 5:30 PM and completely abstain from caloric intake for the remainder of the day (14 hours fast:10 hours eat). Only noncaloric beverages were permitted outside of the eating widow.
~According to the dietary recommendation proposed by Chinese Government and the existing dishes in the canteen , participants are instructed to eat following a high-diet recipe weekly from Monday to Friday which includes whole grain wheat rice, vegetables, fruits, and other foods rich in dietary fiber ."
15753006|NCT04834674|Combination Product|DEB-TACE combined with apatinib and PD-1 antibody|combination of local therapy (DEB-TACE), antiangiogenic therapy (apatinib), and immunotherapy (PD-1 antibody)
15753007|NCT04834661|Other|surgery inside the primary institution|to perform laparoscopic surgery for colorectal and gastric cancer inside the primary registered medical institution
15753008|NCT04834661|Other|surgery outside the primary institution|to perform laparoscopic surgery for colorectal and gastric cancer outside the primary registered medical institution
15753009|NCT04834648|Behavioral|Structured Counseling|"Structured Counseling, which includes A. Counseling is done by a trained counselor
~B. Telephonic Follow up:
~C. Development of Fast Track system at the Base Hospital. D. Provide Health Education Material to all Diabetic Patients. E. Referral communication and feedback between referring and referral facility."
15753010|NCT04834635|Procedure|FundoRingOAGB|laparoscopic one anastomosis gastric bypass with the total wrapping of the fundus of gastric excluded part and with suture cruroplasty if present hiatal hernia
15753011|NCT04834635|Procedure|OAGB|laparoscopic one anastomosis gastric bypass with suture cruroplasty if present hiatal hernia
15753040|NCT04834349|Other|Hafnium Oxide-containing Nanoparticles NBTXR3|Given IT
15753041|NCT04834349|Procedure|Intensity-Modulated Proton Therapy|Undergo IMPT
15753042|NCT04834349|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
15753043|NCT04834349|Biological|Pembrolizumab|Given IV
15753044|NCT04834349|Other|Quality-of-Life Assessment|Ancillary studies
15753045|NCT04834349|Other|Questionnaire Administration|Ancillary studies
15753046|NCT04834349|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15753012|NCT04834622|Behavioral|Melodies for Mums|Melodies for Mums (M4M) is an intervention that was developed and tested as part of a collaboration between the Royal College of Music, Imperial College London and University College London from 2015-2017. The programme involved weekly singing classes for mothers and their babies delivered in groups of 8-12 in Children's Centres for 10 weeks. A trained artist delivers 1-hour long singing sessions to mothers with postnatal depression (and their babies) for a period of 10-weeks. The sessions are aimed at the mothers, with songs ranging from sound baths to folk songs and songs created by the mothers themselves. Mothers randomised to the intervention will be prompted via text message, each week before the session, to attend these singing sessions.
15753013|NCT04834622|Behavioral|Control Community Sessions|Group mother-baby interventions in the community (i.e. baby play, baby reading sessions, baby massage, etc). A list of these activities will be collected from the activities on offer in the community. All the mothers randomised to the control group will be pointed towards these activities, prompted by text messages in line with the prompts received by the mothers in the intervention group. Mothers will be encouraged to attend these non-music based community activities once a week with their babies.
15753014|NCT04834609|Procedure|Injection of autologous adipose tissue in anal fistula|
15753015|NCT04834596|Other|retrospectives analysis on hepatic scanner|hepatic scanner will be analysed by two radiologist and by the software
15753016|NCT04834570|Behavioral|Quality of life in Breast Cancer Survivors|"The patient will receive the following questionnaires to be completed :
~EORTC QLQ-C30
~EORTC QLQ - BR-23
~FACT-B"
15753017|NCT04834557|Drug|Placebo|Placebo will be administered to the control group for 24 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.
15753018|NCT04834557|Drug|Digoxin 0.25 mg|All subjects will receive digoxin administered at 0.25 mg every other day for 24 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.
15753019|NCT04834557|Drug|Ursodeoxycholic acid (UDCA) 500 mg|All subjects will receive Ursodeoxycholic acid (UDCA) administered at 500 mg/day for 24 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.
15753020|NCT04834544|Combination Product|DCVAC/OvCa|An active cellular immunotherapy product containing autologous dendritic cells that are generated ex vivo from patient's monocytes and apoptotic tumor cells prepared from tumor cell lines
15753021|NCT04834544|Combination Product|Placebo|Placebo
15753022|NCT04834531|Drug|Zhuli capsule|This capsule is made from the exact of Phyllostachys glauca McClure or Phyllostachysnuda McClure, which has the expectorant effects. It is oral used,2 capsules for once, three times a day, for 7 days.
15753023|NCT04834531|Drug|Placebo|The placebo capsule is filled with amylodextrin made with food colour and flavor，with the similar appearance, smell and flavor with Zhuli Capsule. It is oral used, 2 capsules for once, three times a day, for 7 days.
15753024|NCT04834531|Other|Standard medical treatment|"Standard medical treatment will be given according to the recent guidelines with the evaluation of the clinicians, include:
~if the patient with AECOPD, he or she will be given with oxygen therapy, bronchodilators, glucocorticoid or antibacterial drugs;
~if the patient with AECB, he or she will be given with antibacterial drugs or anti-asthmatic drugs for asthma attacks."
15753025|NCT04834505|Other|Diagnostic imaging modalities for validation sample|Endoscopic ultrasound and other imaging modalities such as CT, MRI, or PET-CT are performed.
15753026|NCT04834505|Other|EUS for derivation sample|Endoscopic ultrasound was performed.
15753027|NCT04834492|Procedure|Total hip arthroplasty|Total hip arthroplasty in Crowe type 4 developmental dysplasia of the hip.
15753028|NCT04834479|Device|Ankle US and Ankle MRI|Ankle US and Ankle MRI
15753029|NCT04834466|Behavioral|Pain Level experience during orthodontic treatment|A questionnaire was given to patients who have started their orthodontic treatment to assess their pain level experience
15753030|NCT04834453|Diagnostic Test|transcranial ultrasound|- Transcranial Doppler sonography will be performed with the patients in the supine position., using low frequency probe of 2 MHz will be placed on temporal bone- will be performed daily
15753031|NCT04834440|Drug|Ropivacaine|all patients will receive femoral nerve block using same volume of ropivacaine but in different concentrations
15753032|NCT04834427|Drug|Conventional therapy + S (+)-Ketamine|"In principle, there are no specific restrictions on the dosage, mode of administration, timing, and compatibility of S-ketamine hydrochloride injection, but the recommended dosage is given, which is lower than the dosage specified in the instructions.
~Recommended use and dosage of S (+)-Ketamine:
~Intravenous injection：Bolus intravenous injection before skin incision, the dose is 0.1~0.25 mg/kg; Bolus intravenous injection (dose 0.1~0.25 mg/kg) before skin incision + continuous intravenous infusion (dose of 0.1~0.25 mg/kg/h) during operation; Continuous intravenous infusion after surgery with a dose of 0.02~0.1 mg/kg/h for 24~48 h.
~Intramuscular injection：The dose is 2~4 mg/kg."
15753033|NCT04834427|Drug|Conventional therapy|Receiving conventional therapy without S (+)-Ketamine hydrochloride injection. There is no restrictions in drugs, doses and incompatibility, the researchers can choose appropriate medication regimens based on clinical practice, but other NMDA receptor antagonists are not be allowed to use, such as dextromethorphan and amantadine.
15753036|NCT04834388|Drug|Anakinra|Anakinra treatment is started within 8 hours of symptom onset
15753037|NCT04834375|Drug|Weight-based dexamethasone dose|Weight-based dexamethasone dose in COVID-19 patients with hypoxic respiratory failure
15753038|NCT04834362|Drug|Analog Insulin|"For a patient who is known to have diabetes but were not getting insulin previously (or previous insulin dosage is not known), insulin therapy will be started at a total daily dose of 0.3-0.4 units/kg/day for an admission BG between 10-15 mmol/L or 0.5-0.6 units/kg/day for a BG >15 mmol/L. In previously insulin treated patients, ongoing total daily dose of insulin will be started. If there is history of poor glycemic control with ongoing insulin dose, then 10-20% increase of daily dose of insulin will be considered.
~For a patient who is not known to have diabetes, insulin therapy will be started if admission BG is >10 mmol/L in two or more occasions. A total daily dose of 0.3-0.4 units/kg/day will be started if admission BG is 10-15 mmol/L and 0.5-0.6 units/kg/day for a BG >15 mmol/L."
15753047|NCT04834336|Device|inspiratory muscle training device|Inspiratory muscle training will be performed with an inspiratory muscle training device.
15794406|NCT04497649|Drug|Daclatasvir|daclatasuvir once daily
15753049|NCT04834323|Procedure|distal mesogastric fixation after sleeve gastrectomy|Investigators performed traditional laparoscopic sleeve gastrectomy then we fixed the greater omentum & mesocolon that were cut during gastrectomy to the remaining gstric pouch along the new greater curvature as high as possible along the stable line then we plicated the remaining staple line till angle of His. (the greater omentum & mesocolon not reach this part of staple line) , so the remaining gastric pouch remained tension free and was returned to original position and this may prevent the axial gastric rotation
15753050|NCT04834310|Drug|Cefazolin|All patients will receive an intraoperative dose of IV Cefazolin 2 g (re-dose after 4 hours) or IV Clindamycin 600mg (re-dose after 6 hours) for penicillin allergic patients.
15753051|NCT04834310|Drug|Cephalexin|The experimental group will receive a postoperative 5-day course of Cephalexin 500 mg QID or Clindamycin 300 mg QID for penicillin allergic patients. All capsules will be encapsulated with size 00 dark-colored capsules compounded by the UCLA Investigational Pharmacy.
15753052|NCT04834310|Other|Placebo|The placebo group will receive a postoperative 5-day course of placebos (sugar capsules). All capsules will be encapsulated with size 00 dark-colored capsules compounded by the UCLA Investigational Pharmacy.
15753053|NCT04834297|Other|Prapela SVS mattress|The intervention will be using the Prapela SVS crib mattress to complement non-pharmacological management of NOWS for the purposes of prevention of pharmacological treatment of NOWS
15753054|NCT04834271|Other|Side-lying external rotation exercise with a dumbbell|Side-lying external rotation exercise with a dumbbell (20-30% 1RM). 2 times per week during 4 weeks.
15753055|NCT04834271|Other|Side-lying external rotation exercise with a dumbbell with 40% arterial occlusion pressure blood flow restriction|Side-lying external rotation exercise with a dumbbell (20-30% 1RM) with 40% arterial occlusion pressure blood flow restriction. 2 times per week during 4 weeks.
15753056|NCT04834271|Other|Side-lying external rotation exercise with a dumbbell with 80% arterial occlusion pressure blood flow restriction|Side-lying external rotation exercise with a dumbbell (20-30% 1RM) with 80% arterial occlusion pressure blood flow restriction. 2 times per week during 4 weeks.
15753057|NCT04834258|Other|Walking and respiratory training|"Walking and respiratory muscle training group ( W+ RMT) received walking training in addition to respiratory muscle training for a period of 8 weeks.
~Walking training was performed at least 5 days a week, twice a day, for 15 min. Walking distance was calculated according to patients' 6 minute walking distance.
~Respiratory muscle training was performed using the threshold loading method as inspiratory and expiratory muscle training. This training was applied at least 5 days per week, twice a day, 15 minutes each session. (15 minutes inspiratory muscle training + 15 minutes expiratory muscle training). A Threshold Inspiratory Muscle Trainer (IMT) and threshold positive expiratory pressure (Threshold PEP) were used for the training.
~Patients were called for the hospital once a week to asses mouth pressure and 6 minute walking test (6 MWT) and their training intensity was arranged"
15753058|NCT04834258|Other|Respiratory muscle training|In the Respiratory muscle training group, Respiratory muscle training was performed using the threshold loading method as inspiratory and expiratory muscle training. This training was applied at least 5 days per week, twice a day, 15 minutes each session. (15 minutes inspiratory muscle training + 15 minutes expiratory muscle training). A Threshold Inspiratory Muscle Trainer (IMT) and threshold positive expiratory pressure (Threshold PEP) were used for the training. Patients were called for the hospital once a week to asses mouth pressure and their training intensity was arranged.
15753059|NCT04834245|Procedure|Hydrogel/nano silver-based dressing|compare the effectiveness of using hydrogel/nano silver-based dressing vs. traditional dressing on diabetic foot wound healing.
15753060|NCT04834232|Device|compression therapy|compression bandaging or graduated compression hosiery consists of applying a type of elastic device, mainly on the limbs, to exert a controlled pressure on the lower limbs. The controlled pressure exerted by medical compression stockings reduces the diameter of major veins, thereby increasing the velocity and volume of blood flow, along with conditions beneficial for the healing of chronic inflammatory disorders (e.g. cellulitis, erysipelas, venous leg ulcers, etc.), through reduced pro-inflammatory cytokine levels and higher levels of the anti-inflammatory cytokines.
15753061|NCT04834232|Procedure|iliac vein stenting|using x-ray guidance (fluoroscopy) to place a an expandable metal mesh tube against the vein walls, acting as a scaffold to keep the veins open and improve blood flow
15753062|NCT04834219|Procedure|On-Pump CABG|Patients who have undergone on-pump Coronary artery bypass grafting (CABG) surgery are planned by the Department of Cardiovascular Surgery.
15753063|NCT04834219|Procedure|Off-Pump CABG|Patients who have undergone off-pump Coronary artery bypass grafting (CABG) surgery are planned by the Department of Cardiovascular Surgery.
15753064|NCT04834206|Drug|Docetaxel, nedaplatin, fluorouracil|Induction chemotherapy. Docetaxel 60 mg/m2 intravenous day1. Nedaplatin 60 mg/m2 intravenous day1. Fluorouracil 3000 mg/m2 continuous intravenous infusion 120 hours from day1. Every 21 days, 3 cycles.
15753065|NCT04834206|Radiation|IMRT|Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.33 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor.
15753066|NCT04834206|Drug|Nedaplatin|Concurrent chemotherapy. nedaplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.
15753067|NCT04834193|Procedure|Endoscopic ultrasound-guided fine-needle biopsy|Solid lesions will be sampled under endoscopic ultrasound guidance using the two techniques (wet-suction and slow-pull)
15753068|NCT04834180|Dietary Supplement|Hypocaloric diet plan|The hypocaloric diet is one in which there is a reduction of daily calories or foods with high caloric density usually in order to aid weight loss.
15753069|NCT04834180|Other|Auricular Acupuncture|Auriculotherapy is a technique derived from traditional acupuncture developed into a distinct treatment system of its own. It is based on either, the introduction of needles (auricular acupuncture), or pressure with Vaccaria seeds (acupressure). Those forms of auriculotherapy are applied on a set of anatomical maps at a specific point in the auricular region.
15753070|NCT04834180|Other|Acupressure|Auriculotherapy is a technique derived from traditional acupuncture developed into a distinct treatment system of its own. It is based on either, the introduction of needles (auricular acupuncture), or pressure with Vaccaria seeds (acupressure). Those forms of auriculotherapy are applied on a set of anatomical maps at a specific point in the auricular region.
15753194|NCT04833088|Other|Focus group discussions|Focus group discussions will be organized to investigate the needs and requirements of the participants in terms of three pre-defined user scenarios.
15753071|NCT04834167|Device|OneDoc Picopulse|Eligible patients will proceed to receive skin cleansing prior to OneDoc Picopulse treatment. After the cleansing, the patients will receive OneDoc Picopulse treatment for 15 mins. Patients will receive ten picopulse treatments for bi-monthly.
15753072|NCT04834154|Behavioral|Mindfulness|6 weekly 2.0 hour video-conferenced group sessions with the following components: 1) short grounding meditation, 2) check in/review of prior weeks practice and symptoms, 3) educational topic, 3) main meditation, 4) reflection on meditation, and 5) action plan formation
15753073|NCT04834154|Behavioral|Control group|Wait list control
15753074|NCT04834141|Other|FlexiCurve ruler method to assess thoracic kyphosis angle|The determination that the effect of thoracic kyphosis posture on trunk biomechanical alignment may be related to balance may contribute to new treatment recommendations in this area. The aim of this study is to investigate whether the thoracic kyphosis posture has an effect on static balance.
15753075|NCT04834128|Drug|TCB008|administration of gamma delta T cells by IV bolus injection
15753076|NCT04834115|Drug|Ivermectin Tablets|Oral ivermectin at a one time dose
15753077|NCT04834115|Other|Placebo|Oral placebo at a one time dose
15753078|NCT04834102|Diagnostic Test|Blood Tests|Evaluation of blood ferritin, hemoglobine, serum iron and serum iron binding capacity
15753079|NCT04834089|Biological|AntiSARS-CoV-2 Serum|Stage A: 30 kidney transplanted participants (very high risk), where 15 will received 1 vial (5 mL) and 15 will received 2 vials (10 mL) of serum; Stage B: 30 immunocompetent participants with at least 2 risk factors for severe disease (high risk) who will receive the dose selected by stage A; Stage C: 558 participants, of very high risk and high risk, compared with placebo in allocation 2:1.
15753080|NCT04834089|Other|Placebo|Saline solution Administration Route: Intravenous
15753081|NCT04834076|Diagnostic Test|ELISA|ELISA is is a test that detects and measures toxoplasma IgG and IgM antibodies in blood.
15753082|NCT04834076|Diagnostic Test|PCR|Polymerase chain reaction (PCR) is a method widely used to rapidly make millions to billions of copies of a specific DNA sample, allowing scientists to take a very small sample of DNA and amplify it to a large enough amount to study in detail.
15753083|NCT04834076|Diagnostic Test|Sequencing|DNA sequencing is a laboratory technique used to determine the exact sequence of bases (A, C, G, and T) in a DNA molecule. The DNA base sequence carries the information a cell needs to assemble protein and RNA molecules. DNA sequence information is important to scientists investigating the functions of genes.
15753084|NCT04834063|Diagnostic Test|Serum Zinc a level|Diagnostic test
15753085|NCT04834063|Diagnostic Test|serum selenium level|Diagnostic test
15753086|NCT04834063|Diagnostic Test|Fibroscan measurement|Diagnostic test
15753087|NCT04834050|Procedure|Quadriceps femoris isometric home-based exercise|All 3 groups of participants were given 4-week (5 days/week) quadriceps-hamstring isometric home-based exercise training for their both knees. Exercises were performed (with maximal effort for 10 seconds) at a rate of 20 repetitions per day. Training was performed at outpatient clinic for 30 minutes.
15753088|NCT04834037|Behavioral|Behavioral|The provision of information and supportive nursing care is recommended to alleviate anxiety, stress and agitation in COPD patients treated with NIV.
15753089|NCT04834024|Drug|Recombinant Humanized Monoclonal Antibody MIL62, lenalinomide|The patients confirming to the eligibility criteria will receive MIL62 from cycle 1 to cycle 30 and lenalidomide from cycle 1 to cycle 18, unless either rapid disease progression or unacceptable toxicity was observed.
15753090|NCT04834024|Drug|lenalinomide|The patients confirming to the eligibility criteria will receive lenalidomide for 18 cycles, unless either rapid disease progression or unacceptable toxicity was observed.
15753091|NCT04834011|Procedure|Laparoscopic right colonic resection with Complete Mesocolic Excision (CME)|
15753092|NCT04834011|Radiation|3D CT angiography|
15753093|NCT04833998|Drug|Extremecare|The product under investigation (Extremecare) will be supplied as 120g use individual tubes to be applicated in the hands and feet twice a day (once in the morning and once in the evening) beginning with the first cycle of capecitabine and continuing until the end of the fifth cycle of chemotherapy.
15753094|NCT04833998|Drug|Placebo|Placebo cream will be supplied as 120g use individual tubes to be applicated in the hand and feet twice a day (once in the morning and once in the evening) during the fifth cycle of capecitabine therapy.
15753095|NCT04833985|Procedure|LAAC combined with radiofrequency ablation|Each patient received the same group of patients with simple radiofrequency ablation and LAAC
15753096|NCT04833972|Other|Survey questionnaire|Each version of the questionnaire has the same questions about perceived norms about substance use in the community but differs in how the response options are offered.
15753097|NCT04833959|Drug|89Zr-panitumumab|Imaging Agent
15753098|NCT04833946|Other|Andrographis paniculata [150 mg]|One capsule to be taken orally, 30 minutes after breakfast & 30 minutes before bedtime
15753099|NCT04833946|Other|Microcrystalline Cellulose (MCC)|One capsule to be taken orally, 30 minutes after breakfast & 30 minutes before bedtime
15753100|NCT04833933|Other|Phone survey about smoking cessation process since intervention in DISCO trial|We will conduct a phone survey at 2 years follow-up with a random sample of smoking patients at inclusion in DISCO trial, to know the evolution of their smoking habits, the quit attempts since the intervention and the modalities of these attempts.
15753101|NCT04833920|Device|transcranial dirrect current brain stimuation|tDCS (2 mA) targeting the primary motor cortex of the contralateral side of the painful side for 20 minute duration for five sessions in five consecutive days (one session /day),
15753102|NCT04833907|Drug|rAAV-Olig001-ASPA|Intracerebroventricular administration of a single dose
15753103|NCT04833907|Drug|Levetiracetam|Keppra daily dose (20-50 mg/kg/day divided twice daily administered orally or per G-tube) in the post-operative period and continued for 3 months per standard of care to prevent seizure activity.
15753104|NCT04833907|Drug|Prednisolone|Post-operatively, a 3-month steroid taper is planned to prevent or reduce possible delayed immunological responses. This tapering regimen will consist of 0.5mg/kg/day prednisone during weeks 1-4; followed by 0.3 mg/kg/day prednisone during weeks 5-8; and 0.1mg prednisone during weeks 9-12, then off. If there is evidence of new inflammation on MRI at 3-months on T2 FLAIR, the steroid taper will be extended for an additional 3 months or we will transition to steroid-sparing immunosuppression.
15753105|NCT04833894|Biological|Efgartigimod IV|Intravenous infusion of Efgartigimod
15794703|NCT04495010|Biological|Ipilimumab|Specified dose on specified days
15753106|NCT04833868|Other|hippotherapy and schroth exercise|pulmonary function and aerobic capacity were measured in patients with mild idiopathic scoliosis before and after 10-week hippotherapy intervention combined with Schroth exercise
15753107|NCT04833868|Other|schroth exercise|pulmonary function and aerobic capacity were measured in patients with mild idiopathic scoliosis before and after 10-week of Schroth exercise
15753108|NCT04833855|Biological|Tezepelumab Dose 1|Subcutaneous injection.
15753109|NCT04833855|Biological|Tezepelumab Dose 2|Subcutaneous injection.
15753110|NCT04833855|Biological|Omalizumab|Subcutaneous injection.
15753111|NCT04833855|Biological|Placebo|Subcutaneous injection.
15753112|NCT04833842|Other|Web-based childbirth preparation program developed based on health belief model and supported by motivational interview|In the three-month study, primigravida women in the initiative group will be given a web-based childbirth preparation program, which is prepared based on the Health Belief Model and supported by motivational interviews. Before starting the training program, pre-test will be applied to pregnant women and a five-week program will be implemented. A final test will be applied at the end of the program. The birth process will be evaluated immediately after the pregnant women give birth.
15753113|NCT04833842|Other|Web-based childbirth preparation program based on health belief model|In the three-month study, a web-based childbirth preparation program based on the Health Belief Model will be applied to primigravida women in the control group. Before starting the training program, pre-test will be applied to pregnant women and a five-week program will be implemented. A final test will be applied at the end of the program. The birth process will be evaluated immediately after the pregnant women give birth.
15753114|NCT04833829|Behavioral|CHIMES Intervention|"There are six components to the intervention:
~Posters and other print materials to prompt providers and patients to discuss MH care engagement.
~Brief verbal scripts to help HIV providers facilitate patient MH engagement and discuss barriers to MH utilization.
~Expanded MH screening procedures, including at initial intake.
~Case management, emphasizing MH care engagement.
~Interactive trainings for all HIV providers on MH needs, screening/treatment, and barriers to MH service utilization specific to YB-GBMSM.
~Regular case review meetings."
15753115|NCT04833829|Behavioral|Standard of Care|The standard of care practices of referring patients to mental health services of the clinic during Months 1 - 12 of the study.
15753116|NCT04833816|Drug|Administration of drug|Administration of ketamin during the 48h after trauma
15753117|NCT04833803|Behavioral|eBLISS|a novel instrument -Eating Behaviour Lapse Inventory Survey Singapore (eBLISS)- will be developed
15753118|NCT04833790|Behavioral|Free distribution of ORS|Provides will receive 3 months supply of ORS at the beginning of the study to dispense to their patients. They will be asked to dispense the ORS at the market rate and not to give it away to other providers.
15753119|NCT04833790|Behavioral|Standardized patient with ORS preference|Providers will receive a visit from an anonymous standardize patient posing a caretaker for a child with diarrhea who requests ORS to treat their child's diarrhea.
15753120|NCT04833790|Behavioral|Standardized patient with Antibiotic preference|Providers will receive a visit from an anonymous standardize patient posing a caretaker for a child with diarrhea who requests Antibiotics to treat their child's diarrhea.
15753121|NCT04833790|Behavioral|Standardized patient with no preference|Providers will receive a visit from an anonymous standardize patient posing a caretaker for a child with diarrhea who does not request anything specific to treat their child's diarrhea.
15753122|NCT04833790|Behavioral|Standardized patient with no preference + no financial incentive|Providers will receive a visit from an anonymous standardize patient posing a caretaker for a child with diarrhea who does not request anything specific to treat their child's diarrhea. In addition they will inform the provider that they are not going to purchase anything from the provider because they have an uncle with a drug shop where they can get a discount.
15753123|NCT04833777|Drug|Local Anesthetics Lidocaine|10 mL 1% lidocaine with 1:100,000 epinephrine and 1 mL 8.4% sodium bicarbonate
15753124|NCT04833777|Drug|Local Anesthetics Bupivacaine|5 mL 1% lidocaine with 1:100,000 epinephrine + 5 mL 0.5% bupivacaine with 1:100,000 epinephrine and 1 mL 8.4% sodium bicarbonate
15753125|NCT04833764|Drug|Rosuvastatin|Oral administration of 20 mg rosuvastatin for at least 3 months
15753126|NCT04833738|Drug|Hyaluronic acid|
15753127|NCT04833738|Drug|Corticosteroids Triamcinolone Acetonide|triamcinolone acetonide, 40 mg/ml, single dose
15753128|NCT04833738|Other|Electrotherapy|electrotherapy
15753129|NCT04833725|Device|wearable devices|All patients use wearable devices and IoT technology for information collection and data management. Specifically, we build standards from the analysis of sleep monitoring information, and we form an OSA screening model by applying machine learning algorithms.
15753130|NCT04833712|Radiation|Stereotactic Radioablation|Stereotactic Radioablation targets on the pulmonary vein ostium aiming to achieve PVI
15753131|NCT04833699|Other|rubber water bag|hot pack group that 1200 cc warm water (50-550 c) was put in a rubber water bag (Fig 1) and then covered with a cloth and placed on the patients umbilicus at 6, 12, and 18 h after the operation for 30 minutes in addition to clinical standard postoperative care.
15753132|NCT04833686|Behavioral|Mozart|Music composed by Mozart, a musical piece 24 minutes long.
15753133|NCT04833686|Behavioral|Instrumental music|Instrumental music , a musical piece 24 minutes long
15753134|NCT04833686|Behavioral|Silence|Silence, a piece 24 minutes long.
15753135|NCT04833673|Behavioral|PMR: Progressive Muscle Relaxation|tensing and relaxing the body muscles accompanied with deep breathing
15753136|NCT04833673|Behavioral|BRT:Benson Relaxation Technique|relaxation using mental imagery and mediation
15753137|NCT04833660|Device|repetitive transcranial magnetic stimulation|Repetitive transcranial magnetic stimulation (rTMS) is a safe, noninvasive, and effective therapeutic intervention that uses an electromagnetic coil applied to the scalp to produce a magnetic field. rTMS induces changes in cortical excitability at the stimulation site and transsynaptically at distant areas. Cortical excitability is increased by high-frequency (≥5 Hz) stimulation and is decreased by low-frequency (1 Hz) stimulation. The application of high-frequency unilateral rTMS to the motor cortex in patients is reported to have a potential to control various types of pain, such as neuropathic pain, fibromyalgia, and musculoskeletal origin pain (myofascial pain syndrome, shoulder pain, and lower back pain).
15753228|NCT04832854|Drug|Paclitaxel|Paclitaxel at 175 or 200 mg/m^2 will be administered by IV infusion on Day 1 of each 21-day cycle.
15753138|NCT04833647|Diagnostic Test|Cardio-Pulmonary-Exercise-Testing (CPET)|Cardio-Pulmonary-Exercise-Testing (CPET) . During the exercise testing, serial saturation, heart rate and blood pressure measurements were obtained. The peak oxygen consumption (VO2max) was measured and served as the primary endpoint of the study
15753139|NCT04833621|Device|NMES GROUP|The effects of NMES and muscle strengthening and standard physiotherapy exercises on the development of ICU-AW were observed
15753140|NCT04833608|Device|Vktory insoles|Patients were randomized into either the Carbon fiber insole group or Morton's extension group.
15753141|NCT04833608|Device|Morton's extension insoles|Patients were randomized into either the Vktory carbon fiber insole group or Morton's extension insole group.
15753142|NCT04833595|Behavioral|Mindfulness practice|Mindfulness is hypothesised to include reflective practice. Therefore, reflective questions are asked in the questionnaire for intervention group but not for control group.
15753143|NCT04833582|Drug|ZN-c3|ZN-c3 is an investigational drug.
15753144|NCT04833582|Drug|Gemcitabine|Gemcitabine is an approved drug
15753145|NCT04833569|Biological|ICG-PDT|An 810 nm diode laser (A.R.C. laser GmbH, Nurnberg, Germany) with a power of 200 mW (continuous mode) and total energy of 4 J was used to excite the ICG by starting from the papilla for 30 s followed by the insertion inside the peri-implant pocket depth for 10 s from both buccal and lingual side moving to coronal direction. The treatment was applied according to the manufacturer's recommendation. The PDT was performed by a single operator in all test patients
15753146|NCT04833569|Device|peri-implant mechanical debridement|The peri-implant mechanical debridement was done with the help of ultrasonic carbon tip (Vector, Durr Dental, Bietigheim-Bissingen, Germany).
15753147|NCT04833543|Other|Robotic Mobility Device (REX)|A self supporting robotic mobility device (REX) will be utilized. It is a Class I device, and it is classified as powered exercise equipment meant for anyone that requires use of a wheelchair for mobility who has difficulty with standing and walking. The participant will be supported securely within the device using a pelvic harness, and thigh and calf cuffs. The device will be operated under the supervision of a device trained physical therapist and therapy technician. The participant will be transferred into the device in a seated position. Once aligned properly and strapped in, the participant will be passively moved by the device into standing and walking positions. To provide constant vestibular input, a variety of mobility functions will be performed including standing, sitting, walking, turning, shuffling (side-stepping), and backwards stepping.
15753148|NCT04833543|Other|Tilt Table|A tilt table is a table with a footplate that can be tilted at different angles. The participant will lie flat on the table and straps will be placed to stabilize the trunk and lower extremities. The inclination of the tilt table will be adjusted from a horizontal to a vertical position to allow the participant to attain and maintain a standing or partial-standing position. Sessions will be supervised by a physical therapist and therapy technician.
15753149|NCT04833530|Diagnostic Test|Gastric Ultrasound|"In the operating room, a gastric ultrasound will be performed in the supine position and the antral cross sectional area will be measured. Anesthesia will be induced in standard procedure and positive pressure will be instituted according to the standard protocol accepted in our hospital.
~At the end of the procedure, the gastric ultrasound circumference will be measured again."
15753150|NCT04833504|Biological|CD19 CAR-T Expressing IL7 and CCL19|A fourth generation CD19 targeting CAR-T expressing IL7 and CCL19
15753151|NCT04833478|Behavioral|Anxiety|Techniques used to reduce anxiety in paediatric patients.
15753152|NCT04833465|Other|No Intervention|No Intervention
15753153|NCT04833452|Procedure|Endoscopic dacryocystorhinostomy|Endoscopic DCR
15753154|NCT04833439|Other|Fasting Mimicking Diet|Low-caloric, low-protein, plant-based diet regiment for 3 days
15753155|NCT04833426|Drug|Testosterone gel|Topical gel containing testosterone
15753156|NCT04833426|Drug|Placebo|Topical gel without active substance
15753157|NCT04833413|Drug|Continuous intensive insulin therapy|After initial intensive insulin therapy in hospital, patients were grouped according to different treatment regimens within 6 months of discharge
15753158|NCT04833400|Device|ICRS|Patients undergo 30-minute aerobic training with ICRS, 3 sessions a week, for 4 weeks.
15753159|NCT04833400|Device|TAET|Patients undergo 30-minute aerobic training with TAET, 3 sessions a week, for 4 weeks.
15753160|NCT04833387|Drug|PD-1 antibody|Capecitabine:Dose of 1650mg/m2,14days; Radiation:50Gy/25 fractions;IBI308: 200mg on day1 of each cycle, 3 cycles; Surgical therapy:The resection (LAR), intersphincteric resection (ISR), or abdominoperineal resection (APR)
15753161|NCT04833374|Drug|Methylprednisolone|Patients will receive 0.5g/d methylprednisolone intravenously for 3 consecutive days in the 1st-2nd-3rd or 1st-3rd-5th month, then oral prednisone 0.5mg/kg/d on alternate days for 6 months.
15753162|NCT04833348|Other|Motor function measurement using inertial sensors|"Measurement of motor skills at M0: start of the administration of the innovative therapy and then 1 month, 3 months, 6 months, 1 year and then 2 years later:
~Free motor skills in the supine position
~Motricity in the supine position stimulated by a play frame
~Measurement of the proximal and distal activity of the upper limbs in motor skills stimulated by the play gantry
~Measurement of activity in a supported sitting position Longitudinal study, the subject is his own control"
15753163|NCT04833335|Other|MRI perfusion sequence|Quantitative analysis
15753164|NCT04833322|Dietary Supplement|D-Galactose|Galactose supplementation, once per day, up to 1.5g/kg per day
15753165|NCT04833309|Procedure|pharmacopuncture therapy|The procedure will be implemented to participants twice a week for total 5 weeks. The specific prescription including type and dosage will be determined according to the physician's choice, and information will be recorded in the case report form retrospectively.
15753166|NCT04833309|Procedure|physical therapy|The procedure will be implemented to participants twice a week for total 5 weeks. The specific prescription including type and body part will be determined according to the physician's choice, and information will be recorded in the case report form retrospectively.
15753167|NCT04833296|Drug|Ropivacaine|all patients will receive interscalene block using same volume of ropivacaine but in different concentrations
15753195|NCT04833075|Other|blood sampling|A maximum of 13 blood samples (39 mL) will be derived from subjects on treatment. After discontinuation of ICI treatment, a maximum of 7 blood samples (21 mL) will be derived.
15753224|NCT04832854|Drug|Carboplatin|Carboplatin at initial target area under the concentration curve (AUC) of 5 or 6 mg/mL/min will be administered by IV infusion on Day 1 of each 21-day cycle.
15753168|NCT04833283|Device|ReOxy Cardio device, intermittent hypoxic-hyperoxic training ( IHHT)|Perform 4 trainings daily of intermittent hypoxic hyperoxic trainings before surgery, using 40 min trainings periods, the patient will receive air with reduced oxygen content (12 %) through a mask under constant monitoring of heart rate (HR) and SpO2. As a safety measure, minimal SpO2 was set at 82 % and maximal accepted increase of heart rate was set to + 50 % of the initial HR. When these values would be reached, the supply of oxygen automatically switched to a hyperoxic gas mixture (35% - 40% O2), inhaling of which would be continued until SpO2 reached 100% (even if SpO2 would be lower before the procedure), which, depending on the rate of saturation reduction, will takes 1 to 3 min (mean 1 min and 50 s).
15753169|NCT04833283|Device|ReOxy Cardio device|Perform 4 trainings daily of intermittent hypoxic-hyperoxic trainings before surgery, using 40 min trainings periods, whereas moistened air will be delivered through a mask under constant monitoring of heart rate (HR) and SpO2.
15753170|NCT04833270|Other|KM non-pharmacological treatment group|This is a pragmatic setting, and specific intervention is not determined prior to the study. Non-pharmacological treatment including Korean medicine, such as acupuncture, electroacupuncture and chuna, etc, will be chosen by professional physician according to the medical condition of each subject.
15753171|NCT04833270|Other|Pharmacological treatment group|This is a pragmatic setting, and specific intervention is not determined prior to the study. The pharmacological treatment will be chosen by professional physician according to the medical condition of each subject.
15753172|NCT04833257|Drug|GP combine with Tislelizumab neoadjuvant therapy+CCRT|chemotherapy combine with anti-PD-1 targeted immunotherapy+concurrent chemotherapy
15753173|NCT04833244|Behavioral|Triangular Forearm Support|The intervention, the Triangular Forearm Support requires drawing the shoulders away from the subject's head and neck. This requires at least a mild force that this action can oppose. The most-favored maneuver is to have patients stand 2 feet away from a wall, interlock their fingers, and place their forearms to form two sides of an equilateral triangle against the wall. They then place their heads within the triangle, the backs of their heads close to or in on contact with the heels of their hands. Then, pressing against the wall with their elbows and forearms, they draw their shoulders as far away from the wall as possible, retaining contact between the wall and the tops of their heads. Subjects remain in this position for 45 seconds, at which time they stand erect and repeat the abduction and flexion maneuver.
15753174|NCT04833244|Behavioral|Placebo|Patients will be asked to raise arms overhead for 45 seconds.
15753175|NCT04833218|Drug|Propranolol|Test of catecholamines level in moderate traumatic brain injury
15753176|NCT04833205|Drug|Nimotuzumab|Nimotuzumab 200 mg was diluted in 250mL 0.9% sodium chloride injection, intravenously dripping, the duration of administration was controlled over 60 min), and the drug was used continuously for 8 weeks
15753177|NCT04833192|Diagnostic Test|experimental group|DHEAS.24h-UFC,ACTH and cortisol are measured in the experimental group
15753178|NCT04833179|Biological|fecal transplant|"Healthy donors will be selected by the fecal transplant unit, in Tel-Aviv medical center. All donors will undergo a screening process that will include a detailed medical history, blood work and fecal tests. Only after passing the screening, the donor will be added to the groups of donors that will participant in this study.
~The treatment will be givenin the form of fecal capsule. Each capsule will contain a double capsule with 2 layers to ensure that the fecal material will be contained. The treatments will include 30 capsules for the first treatment, that will be taken in two consecutive days, each day 15 capsules. The second, third and fourth treatments will all include 15 fecal capsules. There will be 2 weeks intervals between each treatment."
15753179|NCT04833179|Other|placebo|placebo
15753180|NCT04833166|Device|CMAC D-blade videolaryngoscope with full or partial glottic view|Deliberate achieving full or partial glottic view on C MAC D-blade video laryngoscope and comparing time and ease of intubation with both arms
15753181|NCT04833153|Behavioral|Person-First - Please (PFP)|PFP takes 10 weeks and consist of four modules: Information, Person, Autonomy and Dignity. Information module takes 1 hour contact on first week. The other modules will follow every third weeks, starting from week 2. So that on week 2, 5 and 8 researcher meet nurses in 4 hours education session. Between the modules, nurses can take contact online to the researcher.
15753182|NCT04833140|Drug|Estradiol patch|The patch will provide 100mcg of estradiol daily.
15753183|NCT04833140|Drug|Placebo|Placebo patch will contain no estradiol.
15753184|NCT04833127|Behavioral|Gender-Enhanced -- Masibambane|"The intervention has components that provide PrEP information, provide information about HIV prevention and contraceptive options, prompt women to think about why they may be at risk for HIV, discuss women's sexual rights, and discuss how women can talk to their male partners about PrEP. The components are conducted by participants on their own time as well as during a real-time live interactive session with trained facilitators."
15753185|NCT04833127|Behavioral|Individually accessed|The intervention includes an individually-accessed online PrEP video and South African government websites on PrEP and on contraception options
15753186|NCT04833114|Drug|Polatuzumab Vedotin|Polatuzumab vedotin 1.8 mg/kg will be administered intravenously on Day 1 of each 21-day cycle for up to 3 cycles.
15753187|NCT04833114|Drug|Mabthera|Rituximab (Mabthera/Rituxan®) will be administered as per local practice at a dose of 375 mg/m2 intravenously on Day 1 of each 21-day cycle for up to 3 cycles.
15753188|NCT04833114|Drug|Ifosfamide|Ifosfamide 5000 mg/m² will be administered i.v. over a 24 hr period starting on cycle Day 2.
15753189|NCT04833114|Drug|Carboplatin|Carboplatin AUC 5 max 800 mg will be administered i.v. on cycle Day 2.
15753190|NCT04833114|Drug|Etoposide|Etoposide 100 mg/m² will be administered i.v. on cycle Days 1, 2 and 3.
15753191|NCT04833101|Biological|recombinant Ad5 vectored COVID-19 vaccine|This vaccine contains 5×10^10 virus particles of recombinant replication defective human type-5 adenovirus expressing SARS-CoV-2 S protein, which is produced by CanSino Biologics Inc. It is a liquid dosage form, 0.5 ml / bottle.
15753192|NCT04833101|Biological|RBD-based protein subunit vaccine (ZF2001) against COVID-19|This is a recombinant tandem-repeat dimeric RBD-based protein subunit vaccine (ZF2001) against COVID-19, made by using CHO cell, 25μg/dose, produced by Anhui Zhifei Longcom Biopharmaceutical Co.,Ltd.
15753193|NCT04833101|Biological|trivalent split influenza vaccine|This vaccine contains 15 μ g H1NI, 15 μ g H3N2 and 15 μ g B-series hemagglutinin, produced by Dalian Aleph Biomedical Co., Ltd.It is a liquid dosage form, 0.5 ml / bottle.
15797215|NCT04474314|Drug|Placebo|Oral administration of once daily Placebo
15753196|NCT04833062|Diagnostic Test|Ultrasound|In women presenting for a routine antenatal appointment at 20 gestational weeks an ultrasound assessment will be carried out using the 3.5 MHz abdominal probe in order to assess foetal biometry and anatomy as per the guidelines. We will assess the utility of mid- and third trimester ultrasound parameters for prediction of intrapartal events and perinatal outcomes in patients with diabetes mellitus.
15753197|NCT04833062|Other|Survey|"The maternal baseline characteristics are defined by maternal age at enrollment, parity, number of prenatal visits, some indicators of socioeconomic status and habits, family history of DM (first degree) and prepregnancy hypertension.
~The prepregnancy body mass index (BMI; kg/m2) will be calculated using the self-reported prepregnancy maternal weight; the pregnancy weight gain (kg) will be calculated by the difference between final pregnancy weight and prepregnancy maternal weight and was classified according to the prepregnancy BMI."
15753198|NCT04833049|Drug|TAK-994 Oral Tablet|TAK-994 tablet.
15753199|NCT04833049|Drug|[14C]TAK-994 Intravenous Infusion|[14C]TAK-994 intravenous infusion.
15753200|NCT04833049|Drug|[14C]TAK-994 Oral Suspension|[14C]TAK-994 oral suspension.
15753201|NCT04833036|Drug|Irinotecan|180 mg/m2, ivgtt d1，q2w
15753202|NCT04833036|Drug|cetuximab|500 mg/m2, ivgtt d1，q2w
15753203|NCT04833023|Drug|Haldol 2mg/ml oral solution|"Starting dose: 1mg
~Maximum Dose within 24 hours: 6mg
~Doses can be escalated every 2 hourly to the maximum doses allowed within 24 hours. If maximum dose of Haloperidol has been reached for the day (within 24 hours), rescue dose of Midazolam 2mg can be used (2mg Q2H PRN)."
15753204|NCT04833023|Drug|Olanzapine Actavis 5mg orodispersible tablet|"Starting dose: 2.5mg
~Maximum Dose within 24 hours: 15mg
~Doses can be escalated every 2 hourly to the maximum doses allowed within 24 hours. If maximum dose of Olanzapine has been reached for the day (within 24 hours), rescue dose of Midazolam 2mg can be used (2mg Q2H PRN)."
15753205|NCT04833010|Other|Cardiopulmonary Exercise Test|Participants will complete a Cardiopulmonary Exercise test on cycle ergometer in which they will perform progressive step-exercise cycling to exhaustion
15753206|NCT04833010|Other|Cognitive Performance Test|Cognitive Performance will be tested using a cognition application on an iPad during the Cardiopulmonary Exercise Test.
15753207|NCT04832997|Diagnostic Test|Prostate biopsy systematic random prostate biopsy (TRUS-Bx) + eventual MRI-targeted biopsy (MRI-TBx) + eventual microUS-targeted (Micro-US-TBx)|Patients with both positive mpMRI and Micro-US, defined as the presence of one or more lesions with PI-RADS >= 3 and PRI-MUS >= 3 respectively, will receive a 12-core TRUSBx in addiction to MRI-TBx and Micro-US-TBx. Patients with both negative mpMRI and Micro-US will receive a 12-core TRUSBx. Patients with only positive mpMRI will receive MRI-TBx and 12-core TRUSBx. Patients with only positive Micro-US-TBx will receive Micro-US-TBx and 12-core TRUSBx.
15753208|NCT04832984|Behavioral|Mobile health|Participants will be issued a fitness tracker, Bluetooth enabled glucometer with a custom developed app which they can communicate digitally to the study investigators either as a group or individually. During the first week of the study, participants will be taught on how to use the program, how to interact with their coach, and the importance of maintaining motivation throughout the program. Participants will have access to a pharmacist-participant messaging, group messaging, daily challenges for behavior change, education articles (weekly bite-sized content over 24 weeks), food logging, steps and exercise logging, and feedback. They will be asked to log their weight, meals, and physical activity within the program on a weekly basis. Pharmacist will monitor participant progress through a web-based dashboard. Community pharmacist will be assisting users in setting specific, measurable, attainable, realistic, and time-based goals on a weekly basis.
15753209|NCT04832984|Behavioral|Usual care|Participants will be issued a fitness tracker and Bluetooth enabled glucometer but these functions will not be enabled or linked to any app..All participants will be sent paper version of educational materials but will not have access to a personal coaching but will be able to contact the pharmacist if needed
15753212|NCT04832958|Drug|99m-TC-PSMA-I&S|"99mTc-PSMA-I&S intravenous injection the day before surgery
~99mTc-PSMA-I&S SPECT/CT imaging
~99mTc-PSMA-RGS to detect an increased count rate at the level of the nodal stations"
15753213|NCT04832945|Drug|Ivermectin 6 Mg Oral Tablet|Ivermectin weekly oral dose 0.2 mg/kg equivalent for 4 weeks
15753214|NCT04832932|Biological|COVID-19 vaccine|Emergency-use authorized COVID-19 vaccine
15753215|NCT04832919|Behavioral|Nurse-Community-Family Partnership Intervention|Nurses conduct home visits on a monthly basis for the first five months post-baseline. During visits, nurses emphasize the importance of infection control measures and, jointly with household members, develop and follow-up on the implementation of an infection control plan tailored to the unique circumstances of the household. Nurses deliver training on infection control skills necessary for optimal implementation of the plan. Nurses offer at-home SARS-CoV-2 testing to all members of the household. Nurses conduct triage, medical case management, monitoring, and follow-up of individuals identified to have COVID-19 or any other acute health emergencies. CHWs conduct visits on a bi-weekly basis for the first five months post-baseline. CHWs deliver healthcare information and medical mistrust counseling in a culturally relevant and linguistically appropriate fashion; and provide social support, navigate household members to social welfare/vocational/economic/psychosocial services.
15753216|NCT04832906|Drug|Ulipristal Oral Tablet|A selective progesterone receptor modulator (SPRM), as a medical line of treatment for uterine fibroids. Due to its selective anti-proliferative and pro-apoptotic action, Ulipristal Acetate (UA) is assumed to be effective in reducing abnormal uterine bleeding (AUB) and fibroid size.
15753217|NCT04832906|Procedure|Uterine artery embolization|Selective embolization of uterine arteries bilaterally, using polyvinyl alcohol (PVA) particles administered via a catheter followed by capping with a plug of gelatin sponge. The end point for embolization is to have a static column of contrast in the uterine artery, with only a stump filling when the internal iliac artery was injected.
15753218|NCT04832893|Diagnostic Test|steady intensity aerobic test of 30 minutes long|the use of different type of masks during an aerobic exercise
15753219|NCT04832880|Drug|Baricitinib Oral Tablet [Olumiant]|Baricitinib 4 mg die (2 mg for patients aged > 75 years) for 10 days.
15753220|NCT04832880|Drug|Remdesivir|Intravenous remdesivir 200 mg on day 1, followed by remdesivir 100 mg die until day 10
15753221|NCT04832880|Drug|Dexamethasone|Intravenous dexamethasone 6 mg for 10 days
15753230|NCT04832828|Diagnostic Test|Roth´s Test|Subjets must count from 1 to 30 in their languages, and health professional will count seconds that last in take breath during the count.
15753231|NCT04832815|Behavioral|Equine Therapy|Aim 1: Six session equine interventions. Intervention will be provided one day per week for four weeks. During the first two weeks, each intervention day with consist of two sessions with a lunch break in between. Weeks four and five consist of one trail riding session per intervention day followed by lunch. Each session will be approximately 1.5 hours in length. Sessions 1-4 will occur at the USU Equine Education Center, and session 5-6 will occur on local trails. Optional transportation for participants will be provided from the VA to the intervention site.
15753232|NCT04832815|Behavioral|Therapeutic Horsemanship Program|Aim 2: Therapeutic Horsemanship program utilizes the USU Pathways to Horsemanship model and covers levels of equestrian training from basic groundwork to more advanced riding techniques. Training occurs in a three or six-session format with once weekly sessions over three or six weeks. Mindfulness and mindful self-compassion training may be included.
15753233|NCT04832802|Behavioral|ACCESS|ACCESS-Vets is a customized employment intervention adapted for use in VA healthcare to help Veterans with SCI achieve competitive integrated employment. ACCESS-Vets includes the following elements: discovery, customized employment planning, job development, customized employment negotiation, and accommodations and job retention supports.
15753234|NCT04832802|Behavioral|IPS|IPS is an evidenced-based practice of supported employment that helps persons with disabilities find and maintain integrated competitive employment. IPS follows eight standardized principles: zero exclusion, integrated services, rapid job search, competitive employment, worker preferences, systematic job development, benefits planning, and time-unlimited supports.
15753235|NCT04832789|Device|Venovenous ECMO|Venovenous ECMO
15753236|NCT04832776|Drug|Cetuximab|one group plus cetuximab
15753237|NCT04832776|Drug|Bevacizumab|one group plus bevacizumab
15753238|NCT04832776|Drug|FOLFOXIRI|FOLFOXIRI
15753239|NCT04832763|Procedure|Biospecimen Collection|Undergo collection of blood sample
15753240|NCT04832763|Other|Medical Chart Review|Review of medical charts
15753241|NCT04832763|Other|Physical Performance Testing|Undergo physical function testing
15753242|NCT04832763|Other|Quality-of-Life Assessment|Ancillary studies
15753243|NCT04832763|Other|Questionnaire Administration|Complete questionnaire
15753244|NCT04832750|Device|intermittent theta burst stimulation (iTBS) or sham stimulation|30 sessions of iTBS over 2 weeks (3 sessions per day, 5 days per week)
15753245|NCT04832737|Behavioral|ADDapt Ability Framework|12 week individual therapeutic coaching intervention
15753247|NCT04832698|Other|Survey Administration|Complete survey
15753248|NCT04832685|Device|UP- and DOWN-Modulation|All participants in both groups will receive UP- and DOWN-modulation of the PCC.
15753249|NCT04832659|Behavioral|CEASE|The CEASE intervention is considered the accepted standard of care according to national treatment guidelines. Parents of a child scheduled to be seen at a participating pediatric practice for a 12-month well-child visit will be provided with a brief intake survey. Office staff and clinicians will be trained how to utilize the intake survey system and how to provide evidence-based cessation assistance to parents who smoke. The brief intake survey will conduct screening to identify household smoking. The CEASE system will provide (1) Automatic documentation of smoking cessation services requested; (2) Automatically generated prescription for nicotine replacement therapy for parents who smoke (unless they opt out of receiving the prescription); (3) Automated enrollment in the state's free tobacco Quitline and the SmokeFreeTXT program, a text message program offered by the National Cancer Institute.
15753250|NCT04832659|Behavioral|CEASE + BIO|Children randomized to the CEASE + BIO group will have dried blood spots collected for cotinine measurement at the 12-month well-child visit. Parents of children in the CEASE +BIO group will receive a report of biomarker results followed by proactive outreach from a BIO counselor. The BIO counselor will explain the laboratory results and refer all parents in the household who smoke to tobacco treatment through the parent's primary care provider and/or the state quitline. The BIO counselor will troubleshoot any barriers to obtaining nicotine replacement therapy that may have been prescribed as part of the CEASE protocol and will promote strict smoke-free and vape-free home and car policies. BIO counselors will conduct a maximum of 6 calls per enrolled smoker.
15753251|NCT04832646|Procedure|atrial fibrillation ablation|persistent atrial fibrillation ablation with both AF and sinus rhythm map available
15753252|NCT04832633|Diagnostic Test|Different contrast media injection methods|Different contrast media injection methods
15753253|NCT04832607|Other|Multivirus (CMV, EBV, AdV)-specific T cells|Cell therapy product which is individually produced for each patient and administered via IV bolus injection.
15753254|NCT04832594|Other|AI selection for supplemental breast MRI|An AI tool will generate scores used to determine eligibility. Women randomized to MRI will be examined in an MRI scanner.
15753255|NCT04832581|Behavioral|The Self-Care Behavior Development Program|This program, which is based on the Orem Self Care Model, includes anatomical, physiological and hormonal changes, urinary system infections and preventive measures during pregnancy. The program is different from other researches in that it is based on a methodological theory and is created with up-to-date information.
15753256|NCT04832555|Radiation|Non elective radiotherapy|Simultaneous integrated boost on CTV volumes, delineated as per guidelines, with the exception of intermediate-low risk, where the CTVs are experimental.
15753257|NCT04832542|Other|outpatient follow-up|The patients were evaluated every six months in order to assess the incidence of traumatic syncope recurrence during follow-up after implantable loop recorder implantation.
15753258|NCT04832529|Procedure|No packing of perianal abscess cavity|introducing new method to no packing of abscess cavity.
15753259|NCT04832516|Other|Performing following WHO (World Health Organization)|The CLA group will perform exercises following WHO (World Health Organization) prescription
15753260|NCT04832516|Other|Performing on their needs|The IND group will perform strength, aerobic or flexibility exercises depending on their needs observed during the first assessment.
15753261|NCT04832503|Behavioral|PROMPT- treatment|PROMPTs for Restructuring Oral Muscolar Phonetic Targets
15753262|NCT04832503|Behavioral|LNSOM-treatment|Language Non-Speech Oral Motor Treatment
15753263|NCT04832477|Behavioral|Stigma counseling for PrEP use|This counseling consists of a single-session (45 minute) delivered by trained peer counselors. The primary aims and relevant content areas for counseling are: (1) Assessing and discussing factors known to be drivers of emotional barriers to accessing health care. This counseling aim has two main sub-components: (a) participants will be asked about their prior experiences with accessing health care and their concerns regarding future access, and (b) the counseling will focus on creating personal agency around needing to prioritize one's health. (2) Evaluating concerns around discussing PrEP with health care providers. The counseling combines motivational interviewing with medical decisional balance, which focuses on points to consider when evaluating PrEP. (3) Promoting resiliency beliefs and positive adaptation. For this objective the counselor works with the participant to establish PrEP use goals and problem-solving strategies.
15753264|NCT04832464|Other|RACE Protocol: Balance training along with resistance, aerobic and cognitive exercises.|therapy for the preservation, enhancement, or restoration of movement and physical function impaired or threatened by disease, injury, or disability that utilizes therapeutic exercise, physical modalities (such as massage and electrotherapy), assistive devices, and patient education and training.
15753265|NCT04832451|Behavioral|Interpersonal Relational Role Analysis|"Interpersonal Relational Role Analysis (IRRA) is a psychosocial group intervention that allows individuals to see the problems they experience in interpersonal relationships and interactions in the group environment and to be handled together with group members.
~Similar to Yalom's interactional group therapy model, IRRA sessions comprise warm up, the stages of setting the agenda, working, evaluating, and getting feedback from observers, which are based on the 'here and now' principle. IRRA helps to safely examine the roles in which group members are stuck, in a group environment which is a small example of social life, and these roles are addressed in six steps."
15753266|NCT04832438|Drug|9-ING-41|15 mg/kg as intravenous infusion on Days 1 and Day 4 of a 21-day cycle
15753267|NCT04832438|Drug|Carboplatin|Carboplatin AUC 5 intravenously on Day 1 of a 21-day cycle
15753268|NCT04832425|Drug|PRAX-114|40 mg once daily
15753269|NCT04832425|Drug|Placebo|Placebo once daily
15753270|NCT04832412|Dietary Supplement|BrainPhyt|Low and high doses BrainPhyt supplementation during 24 months
15753271|NCT04832412|Dietary Supplement|100 % sunflower oil|100 % sunflower oil
15753272|NCT04832399|Drug|Natalizumab|As described in the treatment arm.
15753273|NCT04832373|Device|Interaction with humanoid robot|A humanoid robot will be installed for 30 days in children. It has a touchscreen tablet, allowing manual interaction complementing the voice interaction. The robot speaks, hears, and has facial and voice identification.
15753274|NCT04832360|Behavioral|Financial Incentives|Financial incentives may be offered to participants based on their behavioral outcomes (smoking cessation and participation in online psychoeducation about smoking)
15753275|NCT04832347|Other|Exercise|Exercise Group will be given stabilization exercises for a total of 24 sessions, 3 times a week for 8 weeks, each session for 45 minutes.
15753276|NCT04832347|Other|Vagus Nerve Stimulation|Vagus therapy will be applied for 8 weeks, 3 times a week for a total of 24 sessions, each session for 30 minutes.
15753277|NCT04832334|Other|Questionnaire|Imagination ability, balance and functionality of patients will be evaluated.
15753278|NCT04832321|Other|Survey questionnaire|Each version of the questionnaire portrays a young Ugandan man with different profiles of illness severity, treatment, and treatment response.
15753279|NCT04832308|Behavioral|Exercise Therapy|This is a health coach driven exercise prescription for patients recommending 30 minutes or more of moderate effort walking 3-5 days a week with expected walk-rest-walk-rest intervals.
15753280|NCT04832295|Other|photo-supported conversations|"Sessions 1-4: Before each of the sessions, the client photographs that which is related to their well-being and send these to the therapist before the session. The therapist enlarges each of the photographs into the size of A4. The conversation departures from the photographs and the client is encouraged to talk about each of them and they ways it relates to their well-being. Potential strategies for everyday life are discussed.
~Session 5-10: short virtual meetings of approximately 15-20 minutes with the aim to follow the client, confirm their process and support them towards increased well-being.
~Session 11: reflecting upon all their previous photographs. Session 12: reflecting future everyday life upon their photographs."
15753281|NCT04832295|Other|Care as usual|Medication, psychological treatment
15753282|NCT04832282|Device|Napoleon|The Micro-Tech Endoscopic Measurement Device named Napoleon is a small catheter with a 30mm ruler calibrated at 1mm intervals with 5mm demarcations. It is classified as a Class 1, 510(k) exempt device by the FDA. The device was originally intended to measure polyps. However, it is used off-label in this study and is considered investigational.
15753283|NCT04832282|Other|Visual estimation|For each case, endoscopists will first visually estimate the diameter of the GJA by comparing its size to the upper endoscope.
15753284|NCT04832269|Other|Exposure to methylprednisolone during pregnancy|Exposure to methylprednisolone during pregnancy in the context of an MS relapse therapy
15753285|NCT04832256|Device|Radical-7 Pulse CO-Oximeter|COHb measurement monitoring from finger pulp with a non-invasive measurement device called Masimo Radical-7 Pulse co-oximeter (Masimo Corporation, Irvine, USA)
15753286|NCT04832243|Other|Survey questionnaire|Each version of the questionnaire includes a different number of true-false statements that study participants are asked to identify.
15753287|NCT04832230|Other|Hearing test|"The hearing test is composed of several examinations:
~pure tone audiogram
~otoscopy
~tympanometry
~Healthy individuals: The hearing test will be performed at enrollment (Day 0). Patients: The hearing test will be performed at Day 1, Day 3, Day 7 and Day 30."
15753288|NCT04832230|Other|Questionnaire about previous noise exposure|The participant will have to fill in a questionnaire about his/her previous noise exposure at enrollment (Day 0).
15753289|NCT04832230|Other|Otoacoustic emission measurement|"Healthy individuals: Otoacoustic emission will be measured at enrollment (Day 0).
~Patients: Otoacoustic emission will be measured at enrollment (Day 0), at Day 1, Day 3, Day 7 and Day 30."
15753290|NCT04832230|Other|Electrocochleography|"Healthy individuals: Electrocochleography will be performed at enrollment (Day 0).
~Patients: Electrocochleography will be performed at Day 30."
15753291|NCT04832230|Other|Speech audiometry in noise|"Healthy individuals: Speech audiometry in noise will performed at enrollment (Day 0).
~Patients: Speech audiometry in noise will performed at enrollment (Day 0), at Day 1, Day 3, Day 7 and Day 30."
15753292|NCT04832230|Other|Multi-frequency impedance measurement|"Healthy individuals: Multi-frequency impedance will be measured at enrollment (Day 0).
~Patients: Multi-frequency impedance will be measured at Day 30."
15753293|NCT04832230|Other|Assessment of tinnitus severity|Tinnitus severity will be assessed using a visual analogic scale at enrollment (Day 0), at Day 1, Day 3, Day 7 and Day 30.
15753294|NCT04832230|Biological|Blood sample collection|Healthy individuals: A blood sample will be collected at enrollment (Day 0). Patients: A blood sample will be collected at enrollment (Day 0), at Day 1, Day 3, Day 7 and Day 30.
15753295|NCT04832217|Other|Pyrenees´ Beef diet|24 participants were randomly assigned to a Pyrenees' beef diet, 3 serving per week during of 8 weeks.
15753296|NCT04832204|Drug|Apatinib and Camrelizumab for Injection|Apatinib 250mg, Qd, oral administration,SHR-1210 200mg, q3w one week later, intravenous administration, continuous administration until the disease progresses or an intolerable adverse reaction occurs.
15753297|NCT04832191|Device|CE-SM|contrast enhanced spectral mammography &contrast enhanced magnetic resonance imaging
15753300|NCT04832165|Other|Inspiratory muscle strength training|Inspiratory muscle training during 8 weeks, 30 inspirations at 60% of the PIM (maximum inspiratory pressure), 2 times a day for 5 days per week.
15753301|NCT04832152|Other|OT4ASD|Occupational therapy will focus on education and coaching of families/caregivers of children with autism spectrum disorder to help them adapt their daily routines to address their child's sensory needs.
15753302|NCT04832139|Drug|Marstacimab PFP|300 milligrams (mg) subcutaneous injection marstacimab PFP
15753303|NCT04832139|Drug|Marstacimab PFS|300 mg subcutaneous injection of marstacimab PFS
15753304|NCT04832126|Genetic|Genetic analysis|Genomic DNA will be purified from peripheral blood or mouth swabs. Whole blood will be collected by peripheral phlebotomy in tubes containing K2EDTA as an anticoagulant. Blood samples will be stored at 4-8 oC for up to a week before DNA purification. Mouth swabs will be collected using the ORAcollect • DNA kit (OCR-100) (DNA Genotek Inc., Canada). Genomic DNA from whole blood or mouth swab samples will be purified using DNeasy Blood & Tissue Kit (QIAGEN).
15753305|NCT04832113|Other|Adapted Physical Activity and Dietetic|session in addtion conventional management dietetic, hydratation and physical activity
15753306|NCT04832113|Other|conventional management|Dietary and hydratation advices according to the recommendations
15753307|NCT04832100|Drug|Pregabalin 150mg, imipramine 25mg|Conventional treatment for fibromyalgia was given to patients. Clinical follow-ups with questionnaires and interview were arranged then.
15753308|NCT04832087|Drug|Teduglutide|Standard of care Teduglutide dosing
15753309|NCT04832074|Other|Dry Needling|Real Dry Needling in the most active Myofascial Trigger Point
15753310|NCT04832074|Other|Sham Dry Needling|Sham Dry Needling in the same location, but not piercing the skin
15753311|NCT04832061|Other|Respiratory supports|The respiratory supports used in this patient population included conventional oxygen therapy (COT) via nasal cannula or face mask, non-invasive ventilation (NIV), and invasive mechanical ventilation (IMV). NIV has three different methods, including high-flow nasal cannula (HFNC), bilevel positive airway pressure (BiPAP), and continuous positive airway pressure (CPAP).
15753312|NCT04832048|Other|Therapeutic physical exercise|"The physical training program was carried out 3 days a week in 1-hour sessions focused on basic endurance exercises (global body activities), strength (specific muscle region activities) and flexibility.
~Intensity was be determined by Maximum Heart Rate (HRF)."
15753313|NCT04832048|Other|No physical exercise|No programmed physical exercise
15753314|NCT04832035|Other|"coordinated and peer supported mental health care"|Health services, coordination of services, method to support utilization
15753315|NCT04832035|Behavioral|"standard psychotherapeutic care in the public healthcare system"|Psychotherapeutic services that are financed by the public health insurance system.
15753316|NCT04832022|Other|Biological samples|Serum and plasma samples. At baseline, 3, 6 and 12 months
15753317|NCT04832009|Drug|Dextrose 20 % in 500 ML Injection|Dextrose (20% intravenous solution) will be obtained from the Investigational Pharmacy located in the KU Clinical Research Center where studies take place. After fasting for at least 8 hours, dextrose will be administered via antecubital vein at a standard rate of 4 mg/kg/min for 2 hours.
15753318|NCT04832009|Drug|Intralipid|Intralipid ® 20% will be obtained from the Investigational Pharmacy located in the KU Clinical Research Center where studies take place. After fasting for at least 8 hours, Intralipid ® 20% will be administered via antecubital vein at 0.75 mL/min for 2 hours Increases in circulating markers of oxidative stress peak within 2 hours of Intralipid ® 20% infusion in healthy adults (42). An initial heparin bolus of 1000 UL followed by 200 U/hr infusion will be included to activate endothelial lipoprotein lipase and accelerate hydrolysis of fatty acids.
15753319|NCT04832009|Drug|Saline|Saline will be obtained from the Investigational Pharmacy located in the KU Clinical Research Center where studies take place. Will be administered via antecubital vein at 75 to 150 mL/hour for 2 hours.
15753320|NCT04832009|Drug|Ascorbic acid|"(ASCOR) will be obtained from the KU Investigational Pharmacy located in the KU Clinical Research Center where studies will take place. A priming bolus of 0.06 g ascorbic acid/kg fat free mass (FFM) dissolved in 100 mL of saline will be infused intravenously at 5 mL/min for 20 minutes, followed immediately by a drip-infusion of 0.02 g/kg FFM dissolved in 30 mL of saline administered over 2 hours at 0.5 mL/min. The KU Investigational Pharmacy will randomize ascorbic acid or placebo (saline) for each participant."
15753321|NCT04831996|Drug|parsaclisib|parsaclisib will be administered orally after 8 hours of fasting.
15753322|NCT04831957|Diagnostic Test|Assesment of thyroïd function|Blood sample for TSH, fT4, fT3, anti TPO, anti TG thyroid ultra sound Iodine urine sample
15753323|NCT04831944|Drug|parsaclisib|parsaclisib will be administered orally after 8 hours of fasting.
15753355|NCT04831645|Device|DynaNail|Utilization of a novel dynamic compression pseudoelastic intramedullary nail
15753324|NCT04831931|Other|Exercise Program Applied by Telerehabilitation|"Patients will be evaluated 3 times for 4 weeks throughout the study; before the study commences, at the end of 2th and 4th week
~Exercises will be planned to last for 15 minutes a day, and will be progressed and changed weekly throughout the study period. To the exercise program; It will be created as a progressive program by including stretching, normal range of motion movements, neck, core and scapular stabilization and strengthening exercises and the same program will be given to both groups."
15753325|NCT04831918|Device|Mueller cemented cups|Patients undergo total hip arthroplasty with the implant of Mueller cemented cups
15753326|NCT04831905|Device|Micro-wave ablation|Micro-wave ablation
15753327|NCT04831892|Other|Moisturizer Containing Isosorbide Diesters and Colloidal Oatmeal|Study lotion containing 0.1% colloidal oatmeal along with 4% HydraSynol® DOI (Isosorbide Dicaprylate) and 4% HydraSynol® IDL/(Isosorbide Disunflowerseedate)
15753328|NCT04831892|Other|Moisturizer containing Colloidal Oatmeal only|Vehicle lotion containing 0.1% colloidal oatmeal.
15753329|NCT04831879|Device|GONDOLA AMPS|The Gondola device is composed of two units, one per foot, each having two motors that activate rounded stimulation tips that interact with the target points. It delivers mechanical, pressure-based stimulations, sequentially in each of the four points, for the duration of 6 seconds per point. This treatment cycle is repeated 4 times, for an overall treatment duration of less than 2 minutes
15753330|NCT04831853|Other|nasopharyngeal swabbing procedure (self swabbing first)|Patient realises the nasal swabbing himself first, then undergoes conventionnal swabbing
15753331|NCT04831853|Other|nasopharyngeal swabbing procedure (conventionnal swabbing first)|patient undergoes conventionnal swabbing first then realises the nasal swabbing himself
15753335|NCT04831814|Diagnostic Test|Near Focus NBI|Colonoscopy with near focus narrowing band imaging technology . Optical specifications include a 2 mm near field focal depth. Optical diagnosis of polyps were according to NICE and WASP, respectively.
15753336|NCT04831814|Diagnostic Test|Standard Focus NBI|Colonoscopy with narrow band imaging technology.Optical diagnosis of polyps were according to NICE and WASP, respectively.
15753337|NCT04831775|Behavioral|Memory, Attention, and Problem Solving Skills for Diabetes|The intervention is composed of 4 small-group webinar classes and home-based individual online cognitive skills practice and will be held over 8 weeks. The classes will be taught by a GRA. Classes 1 & 2 will focus on common cognitive problems in T2DM and strategies to improve cognitive skills. Classes 3 & 4 focus on lifestyle changes to support cognitive functioning and DM-SM skills. Each online class will follow the same format: (1) introduction/revisiting content from the previous class; (2) review of progress on computer exercises; (3) practicing cognitive strategies in class; and (4) a weekly topic. The GRA will also prescribe exercises for the following weeks.
15753338|NCT04831775|Behavioral|Brain Games|The computer-training component uses a model for cognitive training that adapts to the user through an integrated hierarchical structure. The BrainHQ website houses the interactive program that runs on standard web browsers. Participants will only need a computer, smart phone, or tablet with Internet access to securely log onto the website. Each participant will be registered by the project staff using anonymous ID numbers that will allow unlimited access during the study. The website stores each session completed, and participants can start subsequent sessions wherever they stopped the last time logged on.
15753339|NCT04831762|Behavioral|Attention Network task (computerized)|Computer-based game challenging orienting and executive attention. The subject must chose which side an animal is going, using left and right buttons, depending on the validity of a cue and the congruency of flankers.
15753340|NCT04831762|Behavioral|Head-toes-knees-schoulders|Following motor commands such as touch your head when they are congruent or incongruent.
15753341|NCT04831762|Behavioral|Laby 5-12|Test of motor planning using labyrinths
15753342|NCT04831762|Behavioral|M-ABC 2|Test of motor functions using various subtests of gross and fine motor function.
15753343|NCT04831762|Behavioral|Stroop animals|Stroop test for preK children using animals instead of words
15753344|NCT04831736|Drug|Ketamine|Ketamine at a dose of 0.6 mg/kg will be administered intravenously (IV) while the participant is recovering in the PACU. The study drug will be administered over at least 30 minutes at one time point and will be administered after subject has been deemed to be stable (hemodynamically stable, awake) by the study team on POD 0.
15753345|NCT04831736|Drug|Placebo|Matching equal dose of saline placebo will be administered intravenously while the participant is recovering in the PACU.
15753346|NCT04831710|Drug|Sintilimab|Sintilimab,200mg, ivd, d1
15753347|NCT04831710|Drug|Chidamide|Chidamide,30mg,po,biw,d1-21
15753348|NCT04831697|Behavioral|Multi-Caregiving Intervention|The multi-caregiving intervention consists of group-based, peer support, and nurse-facilitation and includes: a. Storytelling/shared experiences (30 minutes); Peer support and problem solving (30 minutes); Coping strategies (30 minutes); and Structured Diabetes Education and Skills Training (30 minutes).
15753349|NCT04831697|Behavioral|Diabetes Enhanced Usual Care Intervention|This is composed of group-based, nurse-facilitated diabetes education and skills training and general health education and will receive structured diabetes education and skills training as described above (30 minutes) and an additional discussion on general health topics (i.e., back pain, dyspepsia, etc.) (30 minutes).
15753350|NCT04831684|Drug|Placebo|Participants will be getting placebo for 8 days of dosing.
15753351|NCT04831684|Drug|GET73|Participants will be getting GET73 for 8 days of dosing.
15753352|NCT04831671|Other|Surgical Approach - Infra-patella nailing|The intra-medullary nail will be introduced via an infra-patella incision.
15753353|NCT04831671|Other|Surgical Approach - Supra-patella nailing|The intra-medullary nail will be introduced via a supra-patella incision.
15753354|NCT04831658|Drug|Orelabrutinib combined with PD-1 and fotemustine|Orelabrutinib 200 mg,qd,Oral administration; PD-1 200mg D1 dissolved in 100mL 0.9% NS, intravenously ;Fotemustine 100mg/m2 D2 dissolved in 250mL 0.9% NS, intravenously for 1h, protected from light .
15753356|NCT04831645|Procedure|Tibiotalocalcaneal Arthrodesis|Tibiotalocalcaneal (TTC) arthrodesis with a novel dynamic compression intramedullary nail.
15753357|NCT04831632|Diagnostic Test|quantitative and qualitative iFOBTs|They will have their qualitative and quantitative iFOBTs done within the week prior to the VCC study completion. The reading of both of them will be done in Hospital El Cruce's laboratory. The result of the qualitative iFOBT will have two valid expressions: positive or negative.The result of the quantitative iFOBT will be expressed as µg from hemoglobin per gram of fecal matter through the use of automatized equipment for laboratory analysis.
15753358|NCT04831619|Drug|PET scanner with injection of 18 FDG (18F-2-fluoro-2-deoxy-D-glucose) (radiolabel)|A PET scan will be performed in the patients included, in addition to the conventional imaging workup (MRI, endovaginal and pelvic ultrasound).
15753359|NCT04831606|Procedure|debridement|Cleaning of the wound area
15753360|NCT04831606|Device|Offloading|Offloading performed with a standard brace to the calf (Optima Diab, from Molliter).
15753361|NCT04831606|Device|Advanced dressing|Protect the wound with Advanced dressing
15753362|NCT04831606|Device|Blue Light Photobiomodulation|2 minutes irradiation of blue light performed with EmoLED device
15753363|NCT04831593|Other|Group El|Gastric ultrasound is a point-of-care diagnostic tool to examine stomach contents and determine pulmonary aspiration risk at the bedside. Qualitative gastric sonography can determine the nature of gastric content ( empty, clear fluid or thick fluid/solid ) and quantitative gastric ultrasound can estimate the volume of gastric fluid.
15753364|NCT04831593|Other|Group Em|Gastric ultrasound is a point-of-care diagnostic tool to examine stomach contents and determine pulmonary aspiration risk at the bedside. Qualitative gastric sonography can determine the nature of gastric content ( empty, clear fluid or thick fluid/solid ) and quantitative gastric ultrasound can estimate the volume of gastric fluid.
15753365|NCT04831580|Device|da Vinci|Minimally invasive robotic-assisted surgical device
15753366|NCT04831580|Other|open surgery|open radical hysterectomy
15753367|NCT04831567|Radiation|MIBG-I131|Radiopharmaceutical
15753369|NCT04831541|Drug|68Ga-PSMA-11|Each subject receive a single intravenous injection of 68Ga-PSMA-11, and undergo PET/CT imaging within the specificed time.
15753370|NCT04831528|Drug|Cetuximab Ab; Bevacizumab; Vermofenib + cetuximab;Trastuzumab+lapatinib or trastuzumab+pertuzumab; others|After PD, patients received ctDNA testing, and different research protocols were selected according to different gene states of ctDNA, as follows: 1.No secondary changes related to drug resistance were found. Cetuximab cross-line + second-line chemotherapy (FOLFOX/FOLFIRI/ Irinotecan monotherapy, etc.) was used.2. If there is a RAS secondary mutation, change of beacizumab bead sheet resistance + second-line chemotherapy (FOLFOX/XELOX/stand for kang single-agent FOLFIRI mXEIRI/Iraq, etc.);3. If BRAF secondary mutation occurs, replace it with vimofenib + cetuximab + irinotecan;4. If HER2 amplification occurs, replace it with trastuzumab + lapatinib or trastuzumab + pertuzumab;5. In case of other secondary mutations, bevacizumab plus second-line chemotherapy should be replaced.
15753371|NCT04831515|Device|Lens A|daily disposable soft contact lens - test lens
15753372|NCT04831515|Device|Lens B|daily disposable soft contact lens - control lens
15753373|NCT04831502|Drug|TAK-906|TAK-906 Tablets.
15753374|NCT04831502|Drug|TAK-906|TAK-906 Capsules.
15753375|NCT04831489|Radiation|Imaging|pre and postoperative CT scan of lung
15753376|NCT04831476|Other|Patients with Benign Prostate Hyperplasia|patients with benign prostatic hyperplasia under fixed dose combΙnation treatment with dutasteride and tamsulosin
15753377|NCT04831463|Behavioral|Increasising Health Awareness Program for Immigrant Men|The IHAPIM program is a health promotion intervention. The aim of intervention improve health perception and responsibilitiy
15753378|NCT04831450|Drug|Cemiplimab-Rwlc|350 mg Cemiplimab administered via intravenous infusion over 30 minutes on Day 1 of a 21-day cycle.
15753379|NCT04831437|Radiation|Hypofractionated EBRT|EBRT dose of 40Gy in 15 fractions over 3 weeks plus 3 weekly infusions of cisplatin 40mg/m2
15753380|NCT04831437|Radiation|Standard EBRT|EBRT dose of 45Gy in 25 fractions over 5 weeks plus 5 weekly infusions of cisplatin 40mg/m2
15753381|NCT04831424|Behavioral|Trier social stress test|The Trier social stress test (TSST) is a tool for investigating psychobiological stress responses in a laboratory setting. It is a laboratory procedure used to reliably induce stress in human research participants. The study is not examining or validating the test itself but rather using it as a tool to measure the response/focus of study.
15753382|NCT04831411|Procedure|Total Knee Arthroplasty|The extremities of patients admitted to the operating room to be applied TKA will be determined using a safe surgical Fast-Track recovery protocol. Patients will be operated by the same surgical team using the same technique. Spinal anaesthesia or general anaesthesia will be applied to the patients according to the evaluations of the anesthesiologists.
15753383|NCT04831411|Other|Whole Body Vibration|Whole Body Vibration
15753384|NCT04831411|Other|Progressive Resistance Training|Progressive Resistance Training
15753385|NCT04831398|Dietary Supplement|melatonin|A 5mg dose of melatonin spay will be delivered sublingually.
15753386|NCT04831398|Other|Placebo|10 sprays of diluted mint extract. This mimics the sensation and taste of the melatonin spray
15753387|NCT04831398|Other|Control|subject is given nothing
15753388|NCT04831385|Behavioral|Cognitive Behavioural Therapy|CBT is a first line therapy for insomnia
15753389|NCT04831372|Procedure|Off Table Group|Total Hip arthroplasty being performed via the Direct Anterior Approach using a standard operating room table
15753390|NCT04831372|Procedure|On Table Group|Total Hip arthroplasty being performed via the Direct Anterior Approach using a traction table
15753391|NCT04831359|Device|Doppler ultrasound|Tissue Doppler ultrasound on pediatric patients
15753392|NCT04831346|Other|Low level laser|940 nm wavelength with 0.2 W output power and 2 J energy applied for 10 seconds with an energy density of 2.5 J/cm2.
15753393|NCT04831346|Device|Soft occlusive splint|"A vacuum-formed soft occlusal splint made from a 2-mm-thick elastic rubber sheets.
~Participants are instructed to always wear the splint except during mealtimes and oral hygiene."
15753394|NCT04831320|Drug|nab-paclitaxel|Supplied by Celgene Corporation
15753395|NCT04831320|Drug|Nivolumab|Supplied by Bristol-Myers Squibb
15754889|NCT04818632|Drug|AZD9833 with everolimus|Part B: AZD9833 with everolimus dose expansion
15753396|NCT04831307|Other|[68Ga]Ga-HTK03149 PET/CT|200 MBq/m2 of body surface area, with a 200 MBq minimum adult administered activity will be injected intravenously prior to perform the PET/CT
15753397|NCT04831294|Drug|Cannabidiol|Administered orally. Participants will place the liquid in their mouth for 45 seconds before swallowing it.
15753398|NCT04831294|Drug|Placebo|Administered orally. Participants will place the liquid in their mouth for 45 seconds before swallowing it.
15753399|NCT04831281|Drug|ATH-1017|Daily subcutaneous injection of ATH-1017 in a pre-filled syringe
15753400|NCT04831281|Drug|Placebo|Daily subcutaneous injection of Placebo in a pre-filled syringe
15753401|NCT04831268|Other|Glucose as reference food|Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g glucose diluted in 250ml water, tested three times, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.
15753402|NCT04831268|Other|Lentils and lupins mixed meal|Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from lentils and lupins mixed meal along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.
15753403|NCT04831268|Other|Trahanas with tomato sauce mixed meal|Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from trahanas with tomato sauce mixed meal along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.
15753404|NCT04831268|Other|Halva with currants mixed meal|Twelve healthy, normal weight subjects (male: 7, female:7) after 10-14 hr fast, consumed 25g available carbohydrates from halva with currants mixed meal along with 250ml water, tested once, in different weeks, within 10-15min. Fingertip capillary blood glucose samples were takenat baseline, 15, 30, 45, 60, 90 and 120min.
15753405|NCT04831255|Drug|triamcinolone acetonide extended-release injectable suspension|ZILRETTA (triamcinolone acetonide extended-release injectable suspension) injection in the glenohumeral joint administered under ultrasound guidance.
15753406|NCT04831229|Other|Children will perform activities on interactive tablet|AIMG will actively perform activities with user interaction with the equipment through touch or verbal response. Both groups will have a total of 48 intervention sessions.
15753407|NCT04831229|Other|Children will perform passive on interactive tablet|"The PIMG is just a spectator, having contact with the equipment only when switching on / off, play / pause . Both groups will have a total of 48 intervention sessions."
15753408|NCT04831216|Behavioral|Type 2 Diabetes Appropriate Food Boxes + Diabetes Education|All participants will be assigned to a single intervention arm. The intervention includes weekly delivery of type 2 diabetes-appropriate food boxes that include diabetes self-management education materials.
15753409|NCT04831203|Dietary Supplement|An egg-protein hydrolysate (NWT-03)|As described in the experimental arm
15753410|NCT04831203|Dietary Supplement|Placebo|As described in the Control arm
15753411|NCT04831190|Behavioral|Tailored Exercise Intervention|The exercise program to be implemented for neuro-oncology patients will combine aerobic, resistance, balance, and flexibility exercises delivered in one-to-one setting (i.e., personal training) twice per week, for 12 weeks. Based on needs and preferences, participants will have the option to join a circuit-type group class once per week in place of one of their personal training sessions. During COVID-19, all sessions will be delivered remotely. If facilities are open and deemed safe for cancer patients, participants will have the option to attend an in-person session, integrated in the community. Whether delivered in-class or remotely, the intervention will follow exercise progression principles (i.e., frequency, intensity, time, type, overload, and progression) over the 12-weeks, with tailoring of any exercise to meet individual participant needs, with aims of promoting wellness and physical function. The exercise intervention is based on the Alberta Cancer Exercise (ACE) program.
15753412|NCT04831177|Procedure|Laser in situ keratomileusis|Laser in situ keratomileusis LASIK is a procedure used to correct different types of ametropia through a creation of corneal flap whether with femtosecond laser or mechanically with a microkeratome followed by application of excimer laser to correct different refractive errors including Myopia, Hyperopia and Astigmatism.
15753413|NCT04831164|Other|NA (not an interventional study)|(not an interventional study)
15753414|NCT04831151|Drug|Yasmin|Yasmin: 0,03 mg ethinylestradiol + 3 mg drospirenone
15753415|NCT04831151|Drug|Diane-35|Diane 35: 0,035 mg ethinylestradiol + 2 mg cyproterone acetate
15753416|NCT04831138|Procedure|MRI with ASL|"T0 (Week 0): MRI with ASL will be performed either for research alone or along with patient's standard of care imaging session including contrast-enhancement.
~T1 (Day 7+-2): contrast-enhanced research MRI with ASL T2 (Day 14+-2): contrast-enhanced research MRI with ASL T3: MRI with ASL will be performed along with patient's standard of care imaging session.
~T4: MRI with ASL will be performed along with patient's standard of care imaging session.
~T5: MRI with ASL will be performed along with patient's standard of care imaging session."
15753417|NCT04831125|Other|Data collection|Data collection on the use of pacemaker, implantable cardioverter-defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices and leads that are approved for clinical use.
15753418|NCT04831112|Drug|Honey|Dressing of necrotizing fascitis wounds with honey.
15753419|NCT04831112|Combination Product|EUSOL|Dressing of necrotizing fascitis wounds with EUSOL.
15753420|NCT04831099|Drug|Testosterone gel|The route of administration is transdermal.
15753421|NCT04831099|Drug|Placebo|The route of administration is transdermal
15753422|NCT04831086|Drug|Steroid Drug|Steroids doses will be optimized in the intervention group according the risk based on predictive models
15753423|NCT04831086|Drug|Tocolytic Agents|Tocolysis duration will be optimized in the intervention group according the risk based on predictive models
15753424|NCT04831073|Procedure|Surgery on the ascending aorta with or without repair of the aortic root and/or aortic arch|Surgical repair of the ascending aorta with or without surgical repair of the aortic root and/or aortic arch
15753457|NCT04830761|Behavioral|Social|The key constructs targeted by the social module are perceived norms including descriptive norms and injunctive norm. The intervention includes the following techniques: Monitoring of behavior by others, social incentive, social comparison, social reward, restructuring the physical environment, information about others approval, credible source, information about health consequences, feedback on behavior (Michie et al., 2013).
15753425|NCT04831060|Procedure|Periodontal treatment|"For Cases :
~Inclusion; Periodontal bacteria, gingival fluid and unstimulated saliva collection; Teaching of oral hygiene techniques.
~Non-surgical periodontal treatment
~At 3 months = periodontal reevaluation; Periodontal bacteria, gingival fluid and unstimulated saliva collection
~If periodontal pockets greater than 5mm and bleeding persist: periodontal surgery and gingival explant sampling
~At 3 months post-surgery = periodontal re-evaluation; Periodontal bacteria, gingival fluid and unstimulated saliva collection
~Maintenance
~For Controls:
~Inclusion; Periodontal bacteria, gingival fluid and unstimulated saliva collection, teaching of oral hygiene techniques.
~Plastic or pre-prosthetic surgery = gingival explant sampling
~Healing control at 15 days"
15753426|NCT04831047|Drug|Oxymetazoline hydrochloride 0.1% ophthalmic solution|One drop of Upneeq (Oxymetazoline hydrochloride 0.1% ophthalmic solution) will be applied to the ocular surface of each eye.
15753427|NCT04831047|Drug|Placebo|One drop of placebo (balanced saline solution) will be applied to the ocular surface of each eye.
15753428|NCT04831034|Drug|68Ga-FAPI-04|Each subject receive a single intravenous injection of 68Ga-FAPI-04, and undergo PET/CT scanning within the specified time.
15753429|NCT04831021|Procedure|Dialysis without physical exercise|Hemodialysis control condition
15753430|NCT04831021|Procedure|Dialysis with pre-dialytic physical exercise|Patients will pedal for 30 minutes using a ergometer directly attached to the dialysis bed. The exercise will be performed 60 minutes before connection to hemodialysis.
15753431|NCT04831021|Procedure|Dialysis with per-dialytic physical exercise|Patients will pedal for 30 minutes using a ergometer directly attached to the dialysis bed. The exercise will start 30 minutes after the start of dialysis.
15753432|NCT04831008|Other|Figure-of-eight suture|Using the figure-of-eight closure technique when closing access for structural heart therapies.
15753433|NCT04831008|Other|Perclose Device|Using the Perclose device when closing access for structural heart therapies.
15753434|NCT04830995|Dietary Supplement|moderate restricted diet (1800-2000 kcal/day) for four weeks|high intensity interval training 3 sessions for four weeks
15753435|NCT04830982|Drug|IV Diazoxide|500 micromoles added to one liter of cardioplegia
15753436|NCT04830982|Other|Placebo|Placebo added to one liter of cardioplegia
15753437|NCT04830969|Drug|Chlorhexidine gluconate oral rinse|Paroex® is a non-alcohol chlorhexidine preparation. Participants are to use 15 mL morning and evening for 3 months. With use of chlorhexidine, there is risk of reversible staining of teeth and the possibility of some alteration in taste. There is increased likeliness of staining in smokers, coffee drinkers and those who are susceptible to teeth staining in general. The cleaning of the front teeth is provided at the 3-month visit and helps to reduce any staining that may occur. If there is any alteration in taste, it should go away when use of chlorhexidine stops.
15753438|NCT04830969|Procedure|Scaling & Root Planing|SRP is standard treatment of periodontitis. It involves using a scaler to remover subgingival plaque and other debris in the space between teeth and gums.
15753439|NCT04830969|Device|Soft Picks|Soft Picks are a rubber interdental bristle cleaner. Participants are to use Soft Picks morning and evening for all 12 months of the study. They may cause some bleeding of the gums at first usage, but the bleeding should lessen and stop as use is continued (as gums heal). Soft-Picks are a readily available consumer product sold in supermarkets and drug stores.
15753440|NCT04830956|Other|FID123238|Lubricant applied to the ocular surface
15753441|NCT04830956|Other|Systane Hydration|Drops applied to the ocular surface
15753442|NCT04830943|Drug|Cerebrolysin|Cerebrolysin will be prescribed in a dose of 10 ml ampoule once daily through intramuscular injection (1ml contains 215.2 mg cerebrolysin) for five times per week, for a total of 20 treatments (for 4 weeks), after which the cycle was repeated again for at least 8 more weeks.
15753443|NCT04830930|Drug|CKD-381|single-dose, oral administration of CKD-381 1 tablet
15753444|NCT04830917|Other|Immobilization type for mallet injury|Method to hold the DIP joint in full extension to allow healing of terminal tendon injury/mallet injury
15753445|NCT04830904|Device|personalized Lycra garments|the subjects wear lycra garments during the assessment time and for some days after the assessment
15753446|NCT04830878|Drug|Methotrexate|Systemic and intraoperative intravitreal injection of methotrexate
15753447|NCT04830839|Behavioral|Recovery after Stress Toolkit (ReSeT)|ReSeT involves online modules with parallel videoconferencing sessions. ReSeT integrates two evidence-based treatment methods: cognitive behavioral therapy coping skills (coping CBT) and direct exposure to trauma reminders through a trauma narrative.
15753448|NCT04830826|Procedure|Surgeries|Surgeries
15753449|NCT04830813|Drug|Chiauranib|Patients take Chiauranib capsules 50mg, orally once daily, 21 days as a cycle until objective disease progression.
15753450|NCT04830813|Drug|Placebo|Participants received Chiauranib placebo capsule matching Chiauranib orally once daily until objective disease progression.
15753451|NCT04830800|Biological|COVIVAC|COVIVAC vaccine, manufactured by IVAC with or without adjuvant CpG1018 for prevention of COVID-19
15753452|NCT04830800|Biological|Phosphate-buffered saline|Phosphate buffer solution (pH 7.2), manufactured by IVAC
15753453|NCT04830787|Other|no intervention|there is no intervention, we just chose patients diagnosed with hypertrophic cardiomyopathy and underwent CAG, and patients without hypertrophic cardiomyopathy as control ,the two groups are matched with age, gender and hypertension.
15753454|NCT04830774|Device|ILR, PMK, ICD|"Patients receive a newly implanted ILR, PMK, or ICD during COVID-19 hospitalization or within 30 days after hospital discharge and are followed by daily automated remote transmissions.
~Patients have a previously implanted ILR, PMK, or ICD and are followed by daily automated remote transmissions"
15753455|NCT04830761|Behavioral|Motivation|The key constructs targeted by the motivational module are attitudes towards the target behavior, risk perception, outcome expectancies and self-efficacy. The intervention includes the following techniques: information about health consequences, salience of consequences, goal setting (behavior), problem solving, verbal persuasion about capabilities, focus on past success (Michie et al., 2013)
15753456|NCT04830761|Behavioral|Habit|The goal of the habit module is to guide participants to perform correct hand hygiene at self-selected key times repeatedly. The aim is that the behavior will be translated into a habit. The intervention includes the following techniques: Information about antecedents, self-monitoring of behavior, action planning, prompts/cues, habit formation, behavioral practice/ rehearsal, prompts/cues (physical cue) (Michie et al., 2013).
15753458|NCT04830748|Other|Mechanical knee traction|Continuous knee joint mechanical traction will be applied to the patients positioned in supine lying position with the affected knee flexed at 25-30 degrees by a wedge placed under the affected knee. The thigh will be secured with a strap for stabilization and the leg will be held by the specially designed greave with the weight of traction hanging throughout a pulley system. The amount of traction will be set to about 10% of body weight. The treatment will be applied for 20 minutes continuously, once a day, 3 times per week for 4 weeks. The traction force will be progressed gradually during the program ( e.g.: weekly increase force by 1% of body weight if the patient can tolerate the duration of 20 min with the preset force).
15753459|NCT04830748|Other|Therapeutic exercises|"Therapeutic exercises will be divided into stretching and strengthening exercises:
~Stretching will be done passively for the hamstring, rectus femoris and calf muscles. Each exercise will be done for 3 reps each with a hold period of 30-60 secs with a 30-60 rest period between reps.
~Strengthening exercises will be done for the quadriceps and hamstring muscles ( inner range knee extension- knee extension in sitting- straight leg raise in flexion- prone hamstring curl- standing hamstring curl- straight leg raise in extension). Exercise will be done for 3 sets each will consist of 10 reps with a rest period of 2-3 minutes between sets. The starting weight should be 50% of the patient's 1 RM. The end position will be held for 5 seconds. Progression will be achieved by increasing the exercise rep and intensity gradually throughout the program. E.g.: weekly increase force by 5% if patient can tolerate an increased repetition of 20 rep with the preset force."
15753462|NCT04830722|Device|Sculptra Aesthetic|One treatment side treated with Sculptra will be compared to the other side treated with bacteriostatic water (placebo) -same volume
15753463|NCT04830670|Procedure|sinus floor elevation with lateral approach|sinus floor elevation with lateral approach. 6 months healing phase. implant site preparation with trephine bur and bone specimen retrieval.
15753464|NCT04830657|Other|Distant reiki|In order to determine the sample size of the study, it is planned to study with a total of 46 patients, including at least 23 patients in each group, in the power analysis based on the statistics of the statistician and previous studies. The remote reiki group will be given remote reiki 3 times a week for 4 weeks by the researcher who has a reiki application certificate. Remote reiki sessions will be performed by the reiki practitioner the night before the hemodialysis day of the patient, and the session duration will take approximately 36-40 minutes. After the individuals receive 12 sessions of remote reiki (1 month later), the questionnaire will be filled in for the second measurement. In order to determine whether reiki has an effect in the long term, 4 weeks (1 month) after the second measurement, the questionnaire for the third measurement will be completed and the research will be completed.
15753465|NCT04830644|Drug|Iguratimod|Iguratimod orally twice a day
15753466|NCT04830644|Drug|Placebo|Placebo orally twice a day
15753467|NCT04830631|Device|Cathodal transcranial direct current stimulation (tDCS) over the contralesional motor cortex|Cathodal tDCS will be applied to the contralesional motor cortex with 2mA intesntisy for 30 mins/day. Total 10 sessions will be applied.
15753468|NCT04830605|Behavioral|Internet-based treatment|The intervention is an internet-based psychotherapy treatment with eight modules based on acceptance and commitment therapy and with written therapist contact through eight weeks.
15753469|NCT04830592|Biological|NG-641|Patients receive three doses of NG-641 by intravenous infusion.
15753470|NCT04830592|Biological|Pembrolizumab|Patients receive three doses of NG-641 by intravenous infusion and a single dose of Pembrolizumab by intravenous infusion.
15753471|NCT04830579|Drug|Etoricoxib film-coated tablet 120 mg|Etoricoxib is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 120 mg of etoricoxib.
15753472|NCT04830579|Drug|Arcoxia® film-coated tablet 120 mg|Arcoxia® is manufactured by Frosst Iberica SA, Spain. Each tablet contains 120 mg of etoricoxib.
15753473|NCT04830566|Other|Myofascial release technique|Myofascial technique on the thoracolumbar fascia and lumbar paraspinal muscles
15753474|NCT04830566|Other|Simulated Myofascial Release technique|Superficial hands contact on the lumbar area
15753475|NCT04830553|Behavioral|Music-based couple therapy.|"Each couple will receive five treatment sessions, including established methods from client-centered and family-systems psychotherapy as well as Sentire, a technological approach providing immediate sound feedback for physical distance and touch. Duration of the treatment phase: five weeks."
15753476|NCT04830540|Device|OOFOS Recovery Footwear|The OOFOS shoes/ sandals are a commercially available footwear with a compliant, energy absorbing midsole material.
15753477|NCT04830527|Behavioral|EMA prompting for patients|"EMA prompting will consist of the delivery of the PHQ-4 and PANAS questionnaires, as well as basic identification, therapy motivations and expectations, location, current activity and social interactions.
~These prompts will be presented to patients during a 7 day period, 5 times per day."
15753478|NCT04830527|Behavioral|PDF Reports for therapists|After the patients' EMA data is collected, a previously designed R script will summarize and transform the data into a brief and graphic report for therapists in the experimental arm of the study. These reports are intended to provide detailed information about the patients' mood, anxiety levels, positive and negative affects, as well as crossed data such as mood according to location, anxiety according to activity, etc.
15753479|NCT04830514|Other|Recommended Dietary Allowance of Protein|0.8 g/kg/day protein intake
15753480|NCT04830514|Other|Habitual protein intake|1.0 g/kg/day protein intake
15753481|NCT04830514|Other|Optimal Protein Intake|1.5 g/kg/day protein intake
15753483|NCT04830488|Behavioral|e-learning didactic module|Participants utilize e-learning
15753484|NCT04830488|Behavioral|Personal reflection activities|Participants complete questionnaires
15753485|NCT04830475|Device|Non invasive ventilation (NIV)|Patients allocated in NIV Group fulfilled a 120-minute cycle of PSV + PEEP with full-face mask. Ventilation was performed with a Draeger Ventilator with the following basic settings: DeltaPInsp 10 mmHg + PEEP 5 mmHg + Fio2 60%.
15753486|NCT04830475|Device|Conventional Venturi Mask|Patients were offered VenturiMask with Fio2 60% at 15 l / m.
15753487|NCT04830462|Drug|Rifampicin 300 Mg Oral Capsule|Rifampicin 600 mg orally once daily for 4 months
15753488|NCT04830462|Drug|Isoniazid 300 Mg ORAL TABLET|Isoniazid 300 mg daily for 6 months
15753491|NCT04830423|Procedure|Medical ozone injection|Patients in the ozone (O2-O3) injection group will be given intraarticular and periarticular knee injections 3 times as the first dose of 10 μg / ml, the second dose is 15 μg / ml, and the third dose is 20 μg / ml, each session in a volume of 10 ml. Patients will be evaluated according to the study criteria at the beginning, 4 and 12 weeks later by a blinded investigator.
15753492|NCT04830423|Procedure|steroid injection group|In the steroid injection group, 1 ml of betamethasone (6 mg / ml) will be injected once intraarticular knee injection. Patients will be evaluated according to the study criteria at the beginning, 4 and 12 weeks later by a blinded investigator.
15753493|NCT04830410|Dietary Supplement|Fructan reintroduction|Patients will reintroduce fructan powder after 14-day of a low FODMAP diet
15753494|NCT04830410|Dietary Supplement|Placebo reintroduction|Patients will reintroduce placebo powder after 14-day of a low FODMAP diet
15753495|NCT04830397|Drug|QLS-101|Ophthalmic solution 1x daily
15753496|NCT04830397|Drug|Timolol Maleate|Ophthalmic solution 1x daily
15753497|NCT04830384|Device|Fully Active|7 subjects will be dispensed active treatment devices with light and music fully functional
15753498|NCT04830384|Device|LLLT Only|7 subjects will be dispensed active treatment devices with only light functional
15753499|NCT04830384|Device|Music Only|7 subjects will be dispensed placebo comparator devices with only music functional
15753500|NCT04830384|Device|Placebo|7 subjects will be dispensed placebo or sham devices with no light or music functional
15753501|NCT04830371|Biological|EuTCV (Vi-CRM Typhoid conjugate vaccine)|Single dose, Intramuscular administration
15753502|NCT04830371|Biological|Typbar-TCV|Single dose, Intramuscular administration
15753503|NCT04830358|Biological|EuPCV15|15-valent Pneumococcal conjugate vaccine
15753504|NCT04830358|Biological|Prevenar13|13-valent Pneumococcal conjugate vaccine
15753505|NCT04830345|Biological|ATGC-100 100U|Clostridium botulinum toxin type A
15753506|NCT04830345|Biological|Botox 100U|Clostridium botulinum toxin type A
15753507|NCT04830332|Diagnostic Test|abdominal fluid CA-125 levels test|One hundred milliliters of normal saline was used as the abdominal washing liquid to obtain the sample for CA-125 measurement. Serum and abdominal washing fluid CA-125 levels were measured with a double antibody sandwich immunoenzymatic method, using Beckman Coulter DXI (Ireland) analyzer. I
15753508|NCT04830319|Other|Pilates Method|includes exercises in soil, that associate the correct respiratory movement with muscular strengthening and control, stretching from the eccentric movement, selective upper and lower trunk movements. There will be used accessories described by the method for their realization. Participants will perform the first week of awareness and body alignment exercises for 10 minutes, 10 minute breath perception, 10 minute proximal muscle accuracy and control, and 10 minute stretches; from the second week will be included selective trunk movements, with muscle strengthening of lower limbs. Rest intervals will be performed between exercises.
15753509|NCT04830319|Other|task-oriented training protocol|The control-test group (CTG) will initiate the task-oriented training protocol. The task-oriented training protocol will include functional exercise drills, such as sit-up and workout, obstacle course workout, speed-and-direction workout, balance workout, work-up and downhill workout, each tasks performed for eight minutes, with two minutes of rest between them. The difficulty in carrying out the tasks will be progressively adjusted. At all times, individuals will be instructed to contract the pelvic floor musculature. After 20 sessions, the patients will be reassessed and will remain for a period of one month without any intervention, and at the end of this period will be reevaluated again. Next, the CTG group will perform 20 sessions of Pilates exercises.
15753510|NCT04830306|Behavioral|Exercise|Completion of exercise in accordance with assigned protocol
15753511|NCT04830293|Procedure|Carotis Doppler Ultrasound|Neck was rotated about 30-45 ° to the opposite side of the image. The common carotid artery and internal jugular vein were viewed transversely on the B Mode USG image. Then, the probe was rotated approximately 90 ° and the carotid artery was visualized in the longitudinal plane. The probe and guide line were adjusted so that the Doppler angle was 60 °. The image was created with the guiding line parallel to the blood flow. After imaging of the carotid artery bifurcation, measurements were made 1 cm distal to this level.
15753512|NCT04830280|Procedure|posterior quadratus lumborum block|administration local anesthetic solution between the middle layer of the thoracolumbar fascia and QL muscle at the posterior edge of the quadratus lumborum muscle
15753513|NCT04830267|Drug|Camrelizumab|Camrelizumab 200mg IV starting day 1 and then every 2 weeks thereafter. Treatment with Camrelizumab will continue until progression or unacceptable toxicity.
15753514|NCT04830267|Radiation|Stereotactic body radiotherapy|Image guided, stereotactic body radiotherapy (27 Gy over 3 fractions given every other day) to a single lesion to start by study day 14 (study day 1 is day of first dose of Camrelizumab).
15753515|NCT04830254|Device|Transcutaneous Electrical Nerve Stimulation(TENS) device|The Patients in group (A) received low-frequency TENS (frequency 4 Hz, pulse duration 200 μs,burst mode) was be applied through 2 output channels surface electrodes with an E2 TENS device, for 45 min per session, supramaximal stimulation to sympathetic ganglions in T12, L1, and L2, which innervate the lower extremity . For 45 min per session, three times per week, and for 12 weeks.
15753516|NCT04830241|Drug|Antidepressant|Cases reported in the World Health Organization (WHO) and the French pharmacovigilance database of neonatal hypotonia newborns following in utero exposure to antidepressant drugs, with a chronology compatible with the drug toxicity
15753517|NCT04830228|Device|Ballon expandable stent and PTA|Endovascular treatment for the peripheral artery disease of the Iliac artery
15753518|NCT04830215|Drug|Brexpiprazole|Brexpiprazole (flexible dose; 0.5 to 2 mg once daily [QD]) as adjunctive therapy to antidepressant therapy (ADT)
15753519|NCT04830202|Drug|Telisotuzumab vedotin|Intravenous Infusion
15753520|NCT04830189|Device|shoulder sling|Patients were used shoulder slings
15753521|NCT04830189|Device|forearm sling|Patients were used forearm slings
15753522|NCT04830176|Other|dentifrice|use of dentifrices for brushing
15753636|NCT04829162|Other|Mother with obesity, daughter with obesity|Participants in this group were shown an image of a mother with obesity and a daughter with obesity.
15753637|NCT04829162|Other|Mother with obesity, daughter without obesity|Participants in this group were shown an image of a mother with obesity and a daughter without obesity.
15754937|NCT04818216|Drug|Placebo|Placebo capsule containing inert ingredient
15753523|NCT04830163|Combination Product|Phase-dependent paired corticomotoneuronal stimulation (PCMS)|Paired corticomotoneuronal stimulation (PCMS) involves delivering precisely timed pairs of transcranial magnetic stimulation (TMS) and peripheral nerve stimulation (PNS) so that the neuronal activity evoked by such stimulation arrives synchronously at corticospinal-motoneuronal synapses. This synchronous arrival is postulated to cause long-term potentiation via spike timing-dependent plasticity, which then improves corticospinal transmission and hand function. In this study, paired corticomotoneuronal stimulation (PCMS) will be applied during specific brain states that reflect increased recruitment of motoneurons via the corticospinal tract. This increased recruitment is expected to enhance the beneficial effects of PCMS on human hand function after stroke.
15753524|NCT04830150|Behavioral|Supportive interventions on the stress levels of mothers of infants hospitalized in the Neonatal Intensive Care Unit (NICU).|This study was conducted to determine the effects of supportive interventions on the stress levels of mothers of infants hospitalized in the Neonatal Intensive Care Unit (NICU).
15753526|NCT04830124|Drug|Nemvaleukin Alfa Subcutaneous|Subcutaneous injection of nemvaleukin every 7 days
15753527|NCT04830124|Drug|Nemvaleukin Alfa Intravenous|Intravenous (IV) infusion over 30 minutes given daily for 5 consecutive days
15753528|NCT04830111|Device|heart rate variability biofeedback Application (Eureka iDestressor)|heart rate variability biofeedback protocol duration time is 10 min twice/day for 5days
15753529|NCT04830098|Other|Spinal stabilization exercises|It will be given stabilization exercises for a total of 18 sessions, 3 times a week for 6 weeks, each session for 45 minutes.
15753530|NCT04830098|Other|Chiropractic manipulation|It will be applied high-speed low-amplitude (HVLA) chiropractic manipulation for a total of 6 sessions, once a week for 6 weeks.
15753531|NCT04830085|Procedure|Hysterectomy|Hysterectomy (abdominal, vaginal or laparoscopic)
15753532|NCT04830072|Behavioral|Brief AWARD advice and active referral to somking cessation services|The AWARD advice includes: (1) Ask about smoking history; (2) Warn about the high risk of smoking; (3) Advise to quit or reduce smoking as soon as possible; (4) Refer smokers to smoking cessation services (with a referral card); (5) Do it again: to repeat the intervention.
15753533|NCT04830072|Behavioral|Chat-based support through Instant Messaging apps|Participants in the intervention group will receive 3 months of chat-based support through Instant Messaging apps (e.g., WhatsApp, WeChat). The support mainly includes (1) regular messages on health warnings, benefits and methods of quitting, coping craving approach, and promotion to use the SC services; (2) real-time, personalized, and interactive behavioral and psychosocial support through Instant Messaging apps.
15753534|NCT04830072|Other|Leaflet|Leaflet on harms of smoking
15753535|NCT04830072|Behavioral|AR images|AR images of the harms of smoking and the benefit of abstinence.
15753536|NCT04830059|Behavioral|Exercise|Two types of exercise intervention and control group
15753537|NCT04830059|Behavioral|Air purification|Air purification in order to reduce the PM2.5 and PM10
15753538|NCT04830033|Other|ENO Breathe group|Six weekly group online workshop sessions, led by an ENO vocal specialist. Workshops will encourage participants to take part in exercises and activities especially designed to support breathing control, providing tools for self-management of breath and anxiety. They will also have access to bespoke online digital resources, designed to support participants between sessions. These will include exercises, song sheets and audio and video materials, especially recorded by the ENO for participants on the programme.
15753539|NCT04830020|Drug|HMW-HA|Aerolized administration b.i.d.
15753540|NCT04829994|Device|Intervention|There is no intervention, beyond necessary clinical care, in this study. The surgical procedures being performed within the study are identical to the surgical procedures subjects would receive as part of SOC.
15753543|NCT04829968|Other|gingival conditions control|"Peri-implant mucositis: It was diagnosed on the basis of the following criteria:
~Visual inspection demonstrating the following signs of inflammation in the peri-implant region: red as opposed to pink colour, swollen tissues as opposed to no swelling, and soft as opposed to firm tissue consistency.
~Presence of profuse (line or drop) bleeding and/or suppuration on probing.
~An increase in probing pocket depths (PPDs) compared to baseline. • Peri-implantitis: It was diagnosed on the basis of the following criteria:
~1. Visual inflammatory changes in the peri-implant soft tissues combined with bleeding on probing and/or suppuration.
~2. Increasing PPDs as compared to measurements recorded at the time of placement of supra-structures."
15753544|NCT04829955|Other|Eccentric manual resistance training|Eccentric bodyweight resistance training
15753545|NCT04829955|Other|Concentric manual resistance resistance training|Concentric bodyweight resistance training
15753546|NCT04829942|Behavioral|positive health behavior|Training on nutrition, physical activity, first aid, individual hygiene, violence and bullying will be provided to the initiative group.
15753547|NCT04829929|Device|Omega™LAA Occluder implantation|Left Atrial Appendage closure for patients with non-valvular atrial fibrillation (NVAF) and high bleeding risk by Omega™LAA Occluder using Omega™ Delivery System
15753548|NCT04829916|Drug|RMC-035|Multiple dosing during 48 hours following cardiac surgery
15753549|NCT04829916|Drug|Placebo|Multiple dosing during 48 hours following cardiac surgery
15753550|NCT04829903|Drug|Dulaglutide|Dulaglutide injections
15753551|NCT04829903|Drug|Liraglutide|Liraglutide injections
15753552|NCT04829877|Behavioral|Web-based mind-body intervention with HRVB|The web-based mind-body intervention with HRVB contains the following components: 1) Breathing training with HRV biofeedback; 2) 5 different topics will be included ; 3) Home exercise of slow breathing and mindfulness exercise.
15753553|NCT04829877|Behavioral|Web-based mind-body intervention|The web-based mind-body intervention will receive 5 different topics courses.
15754257|NCT04824092|Drug|Doxorubicin|Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
15753554|NCT04829864|Behavioral|STEP|"The program is offered by two facilitators to groups of three to seven women, in-person or online. The program is divided in three phases entitles Becoming a mother; A look at my own history and Looking ahead. The first phase aims to explore and normalize the emotions experienced by the participants in the course of their pregnancy and to support the use of healthy emotion regulation strategies. The second phase aims to support mentalization of trauma, by discussing the nature of trauma and its impact; by validating participants' feelings as understandable responses to trauma; by supporting a reflection on positive and harsh experiences with significant others and the ways both types of experiences influenced participants' mental states; and identifying how participants coped with trauma. In the last phase, discussions focus on participants' needs and strengths, on available resources to support resilience and envision positive and challenging moments with the child."
15753555|NCT04829851|Device|PROTEIN Mobile App|All recruited user groups will be expected to use the PROTEIN app. During this study the subjects will be asked to visit the lab followed by at least 4 weeks usage of the PROTEIN app and then a final lab visit.
15753556|NCT04829851|Device|Expert Dashboard|Health care professionals (HCP) will be contacted via email and will also be invited to either attend the lab or meet with the researchers utilizing Zoom/ Microsoft teams to discuss the usage of the expert dashboard within the PROTEIN application.
15753557|NCT04829838|Drug|intravenous levetireacetam|phenytoin is considered as control drug in the study
15753558|NCT04829825|Diagnostic Test|18F-GP1 PET/MR|Patients will receive 1-3 18F-GP1 PET/MR
15753559|NCT04829799|Drug|1% preservative-free lidocaine|Instillation of intracameral lidocaine after initial paracentesis incision.
15753560|NCT04829799|Drug|Phenylephrine 1.0%/ Ketorolac 0.3%|Instillation of Omidria irrigation solution after paracentesis incision and in irrigation solution.
15753561|NCT04829786|Drug|palovarotene low-dose|oral capsules
15753562|NCT04829786|Drug|palovarotene high-dose|oral capsules
15753563|NCT04829773|Drug|Palovarotene|oral capsules
15753564|NCT04829773|Drug|midazolam|oral syrup
15753565|NCT04829760|Dietary Supplement|Psyllium|Participants will consume 10 grams of fiber from psyllium in two doses each day for 8 weeks
15753566|NCT04829760|Dietary Supplement|Coarse wheat bran|Participants will consume 10 grams of fiber from coarse wheat bran in two doses each day for 8 weeks
15753567|NCT04829760|Dietary Supplement|Maltodextrin|Participants will consume maltodextrin in a volume equivalent to the psyllium intervention (~2 tablespoons) in two doses each day for 8 weeks
15753568|NCT04829747|Drug|Atogepant|Oral Tablet
15753569|NCT04829734|Device|Active PBMT-sMF|The Active PBMT-sMF will be applied using MRM® MR5 Prototype manufactured by Multi Radiance Medical (Solon, OH, USA). PBMT-sMF will be applied using the direct contact method with light pressure on the skin. The PBMT-sMF will be applied in four regions of the epicondyle and the application time will be 60 seconds per region. The total dose of PBMT-sMF will be 108,30 J per treatment session.
15753570|NCT04829734|Device|Placebo PBMT-sMF|The Placebo PBMT-sMF will be applied using MRM® MR5 Prototype manufactured by Multi Radiance Medical (Solon, OH, USA). Placebo PBMT-sMF will be applied using the direct contact method with light pressure on the skin. The Placebo PBMT-sMF will be applied in four regions of the epicondyle and the application time will be 60 seconds per region. The total dose of Placebo PBMT-sMF will be 0 J per treatment session and the sMF will be turned off. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (active or placebo).
15753571|NCT04829721|Other|Educational Intervention with video|Women randomized to an educational video workshop group.
15753572|NCT04829708|Other|MRI Surveillance|Receive MRI surveillance
15753573|NCT04829708|Radiation|Prophylactic Cranial Irradiation|Receive PCI
15753574|NCT04829695|Drug|Artesunate-amodiaquine drug combination|Artesunate-amodiaquine is co-packaged as artesunate 50 mg and amodiaquine hydrochloride USP equivalent to amodiaquine base of 153.1 mg. Each child shall be given one, two or three tablets depending on the weight.
15753575|NCT04829695|Drug|Artemether-lumefantrine drug combination|Artemether-lumefantrine is formulated as tablets and will be provided in blister packs. Each tablet contains 20 mg artemether and 120 mg lumefantrine. Every pack has a picture showing how the drug should be given and contains two blisters for each day with one, two or three tablets depending on the weight of the child.
15753576|NCT04829682|Behavioral|ACT for Life|ACT for Life is a brief recovery oriented individual inpatient Acceptance and Commitment Therapy treatment protocol consisting of four modules typically administered in three to six inpatient sessions and one to four outpatient sessions in the 30 days following discharge from inpatient care. The immediate goals of ACT for Life are to increase the participant's psychological flexibility and readiness to cope effectively with future suicidal crises.
15753577|NCT04829682|Behavioral|Present Centered Therapy|PCT is an evidence-based treatment for PTSD but its principles can be applied to psychotherapy for a wide range of difficulties. The standard PCT manual was originally adapted for suicide prevention by Craig Bryan and his colleagues. Our study team made additional minor revisions to prepare the manual for use as an active control condition in the current efficacy trial. PCT includes two initial sessions focused on discussion of current symptoms, psychoeducation, and the rationale for PCT. Current life problems become the focus of the remaining sessions. PCT is expected to consist of three to six, 60-90-minute inpatient sessions and one to four outpatient sessions in the 30 days following discharge. Discontinuation will occur when the participant attends an individual outpatient mental health appointment or 30 days after discharge, whichever occurs first. PCT participants will receive caring communications from their therapist for 12-months following inpatient discharge.
15753578|NCT04829643|Diagnostic Test|PET/MRI|A consecutive cohort of 247 patients with early BC and no suspicious nodes at both clinical and A-US evaluations and candidates to upfront surgery and SNB will be recruited
15753579|NCT04829630|Biological|rabies vaccine|"day 0 : questionnaire, blood sampling and vaccine booster (a single session of two intradermal doses of 0.1 mL)
~day 7 : questionnaire and blood sampling"
15753638|NCT04829162|Other|Mother without obesity, daughter with obesity|Participants in this group were shown an image of a mother without obesity and a daughter with obesity.
15753639|NCT04829162|Other|Mother without obesity, daughter without obesity|Participants in this group were shown an image of a mother without obesity and a daughter without obesity.
15753640|NCT04829162|Other|Mother with obesity, son with obesity|Participants in this group were shown an image of a mother with obesity and a son with obesity.
15753580|NCT04829617|Behavioral|PP-MI Intervention|The 12-week PP-MI intervention focuses on enhancing well-being (through PP) and promoting adherence to physical activity, diet, and medications (through MI). Each week, participants will complete a PP activity and work towards one or more health behavior goals, then complete a phone session with a study trainer. The PP portion of the program will focus on the cultivation of well-being through the performance of easy-to complete activities (e.g., using a strength in a new way) and review of the positive feelings they generate. The MI portion of the program will focus on assisting participants to monitor health behavior adherence, resolve ambivalence to behavior change, set realistic health behavior goals, problem-solve barriers, and identify resources to complete behavior change. Finally, participants will receive twice weekly text messages (for 24 weeks) to encourage completion of PP activities and engagement in health behaviors.
15753581|NCT04829617|Behavioral|MI-alone Intervention|The time- and attention-matched MI-alone intervention focuses on providing education about heart failure (HF) and promoting adherence to physical activity, diet, and medications. Each week, participants will independently complete an activity related to HF education or adherence to a health behavior, then complete a phone session with a study trainer. HF educational topics will include the causes and types of HF, risk factors for cardiovascular disease, methods for monitoring risk factors and symptoms, and the importance of adherence to physical activity, diet, and medications. For each health behavior, study trainers will assist participants to monitor adherence, identify realistic behavior goals, problem-solve barriers, and identify resources to complete behavior change. Finally, participants will receive twice weekly text messages (for 24 weeks) that provide education and encourage engagement in health behaviors.
15753582|NCT04829604|Drug|ARX788|The active pharmaceutical ingredient in ARX788 is an antibody drug conjugate (ADC) consisting of a humanized anti-HER2 monoclonal antibody (mAb) (IgG1κ) covalently conjugated to two microtubule-disrupting payloads AS269
15753583|NCT04829591|Other|observational|Heart failure, non interventional
15753584|NCT04829578|Other|Hypnosis|Chronic idiopathic pruritus is treated by hypnosis
15753585|NCT04829565|Drug|Botulinum toxin|echo-guided injection into the trapezo-medial-phalangeal jointof 0.5 ml of botulinum toxin 50 IU
15753586|NCT04829565|Drug|Placebo|echo-guided injection into the trapezo-medial-phalangeal jointof 0.5 ml of placebo
15753587|NCT04829539|Behavioral|Behavioral Intervention|Receive BBT-CI
15753588|NCT04829539|Behavioral|Behavioral Intervention|Receive HEAL
15753589|NCT04829539|Other|Quality-of-Life Assessment|Ancillary studies
15753590|NCT04829539|Other|Questionnaire Administration|Ancillary studies
15753591|NCT04829526|Other|data collection|Retrospective extraction of demographic, clinical, laboratory, and electrophysiological data from the digital medical records
15753592|NCT04829513|Other|kinesio taping|In kinesiology taping with the inhibition method, an I-shaped tape of 15-20 cm in length will be applied on the sacroiliac joint on both sides without stretching the ends with 50% stretching in the middle. In addition, a 25-30 cm long I band will be applied over the right spina iliaca posterior superior, towards the left spina iliaca posterior superior. In the facia correction technique, 2 bands with no cut ends, a 10-15 cm web-shaped band divided into 4 or 5 parts with a width of 1-15 cm will be applied cross over the sacroiliac joint, without stretching the ends with 50% stretching in the middle.
15753593|NCT04829500|Behavioral|Montessori Approaches to Person-Centered Care (MAP-VA)|Montessori approaches to person-centered care (MAP-VA) introduces practical strategies that frontline staff can use for successful engagement of residents through retained abilities. Staff are also introduced to concrete strategies that improve dignity, control, and independence. MAP-VA is based on the work of Maria Montessori who demonstrated that a structured, supportive environment and meaningful, active roles in the classroom enabled children to fulfill their greatest potential physically, mentally, and emotionally. Montessori principles have been applied to dementia care for more than 20 years to promote functional independence, meaningful engagement, and dignity.
15753594|NCT04829487|Drug|Ergocalciferol Capsules|Given to subjects 50,000 IU per week for 8 weeks
15753595|NCT04829487|Drug|Placebo|Placebo capsules
15753596|NCT04829474|Other|Survey|It is a survey that the patient and doctor must complete.
15753597|NCT04829461|Device|Ambu® aScope™ 4 Cysto with the aView™ 2 Advance used for stent removal|Procedure using a single-use cystoscope for stent removal
15753598|NCT04829461|Device|Standard of care reusable cystoscope used for stent removal|Procedure using a reusable cystoscope for stent removal
15753599|NCT04829448|Dietary Supplement|Protein supplement|Protein supplement equivalent to Metagenics Ultrameal
15753600|NCT04829435|Drug|ALLN-346|ALLN-346 (Engineered Urate Oxidase) is an orally administered, novel urate oxidase; provided as capsules for oral administration; It is a proprietary enzyme designed to degrade urate in the intestinal tract
15753601|NCT04829435|Drug|Placebo|Matched placebo capsules are similar in weight and appearance to the ALLN-346 capsules
15753602|NCT04829422|Drug|Lazertinib 240 mg|The initial dose of lazertinib 240 mg (3 tablets of 80 mg lazertinib) once daily can be reduced to 160 mg once daily (2 tablets of 80 mg lazertinib) under specific circumstances
15753603|NCT04829409|Procedure|Paravertebral block|Patients receive ultrasound-guided paravertebral block
15753604|NCT04829409|Procedure|ESP block|Patients receive ultrasound-guided erector spinae plane (ESP) block
15753605|NCT04829409|Procedure|MTP block|Patients receive ultrasound-guided mid-point transverse process to pleura (MTP) block
15753606|NCT04829396|Other|placebo|Powder consisting of 13 g of digestible carbohydrates with similar appearance as the investigational fibre mixture.
15753607|NCT04829396|Dietary Supplement|Fibre mixture|The study product is a fibre mixture consisting of a mix of 10 g of Acacia Gum and 3 g of carrot fibre taken p.o. o.d. in powder form for a total of approximately 10 g of dietary fibre per day.
15753610|NCT04829370|Other|PLT|The study will be conducted by using a fractional carbon dioxide laser for acne scar treatment. After the treatment, each patient enrolled will be applied 2 mL PLT solution on the right face. Treatment mentioned above will be repeated every 3 to 4 weeks, overall 4 times treatment and one month follow up after fourth treatment. Every record will be documented in questionnaires by the principal investigator and the patient itself. Moreover, VISIA is applied for objective observation, such as spots, wrinkles, texture, pores, UV spots, brown spots, red area, and porphyrins could be objectively analyzed.
15753611|NCT04829370|Other|Saline|"The study will be conducted by using a fractional carbon dioxide laser for acne scar treatment. After the treatment, each patient enrolled left face be applied 2 mL normal saline.
~Treatment mentioned above will be repeated every 3 to 4 weeks, overall 4 times treatment and one month follow up after fourth treatment. Every record will be documented in questionnaires by the principal investigator and the patient itself. Moreover, VISIA is applied for objective observation, such as spots, wrinkles, texture, pores, UV spots, brown spots, red area, and porphyrins could be objectively analyzed."
15753612|NCT04829357|Device|Intervention|There is no intervention, beyond necessary clinical care, in this study. The surgical procedures being performed within the study are identical to the surgical procedures the subjects would receive as part of SOC.
15753613|NCT04829344|Drug|AG-920|AG-920 Sterile Topical Ophthalmic Solution
15753614|NCT04829344|Drug|Placebo|Placebo Topical Ophthalmic Solution
15753615|NCT04829331|Device|Restrata|Restrata is a sterile, single use device intended for use in local management of wounds
15753618|NCT04829305|Drug|SHR2285|SHR2285 is a selective inhibition of human FXIa small molecule compound.
15753619|NCT04829292|Behavioral|Supportive therapy and CBT|In this open trial participants are first offered supportive therapy followed by CBT
15753620|NCT04829279|Other|CONNECT AI system group|"A. During the Intervention period, paramedics wear equipment for multi-faceted data acquisition and press the start button of the system.
~B. During the Intervention period, inside the ambulance, a application that implements a function that automatically evaluates the patient's severity, displays a list of optimal transfer hospitals based on this, and shares real-time information of the hospitals, is installed so that paramedics can refer to the work.
~C. ED's medical staff will receive through ER-kiosk pre-hospital patient information collected and analyzed through the CONNECT AI system before arrival."
15753621|NCT04829266|Behavioral|mental simulation|Audio recordings with a mental simulation. The women listened to the text using headphones about 10-15 min before verticalization (5 h after arrival in the postoperative room, about 6 h after anesthesia). In each group, the mental training lasted for about 10 min.
15753622|NCT04829253|Behavioral|Dialectical Behavior Therapy -3-months|Modification of affect regulation, behavioral regulation, interpersonal functioning and identity functioning through the use of skills training, phone check-ins, crisis management and individual initial assessment.
15753623|NCT04829253|Behavioral|Dialectical Behavior Therapy -6-months|Modification of affect regulation, behavioral regulation, interpersonal functioning and identity functioning through the use of skills training, individual psychotherapy, coaching calls and treatment-team consultation.
15753624|NCT04829240|Behavioral|Veterans Anxiety Skills Training Intervention|Modular anxiety intervention designed for Primary Care-Mental Health Integration settings, including up to six 30-minute sessions occurring approximately every 2 weeks, in which Veterans select modules of interest to them to complete, with an emphasis on psychoeducation and cognitive-behavioral coping strategies for self management of anxiety symptoms
15753625|NCT04829240|Behavioral|PCMHI Usual Care|Appointment with Primary Care-Mental Health Integration provider at local primary care clinic for anxiety treatment; provider delivers whatever interventions they deem appropriate and collaboratively decides with patients whether and when to meet again as in routine PCMHI care
15753626|NCT04829227|Device|Sofwave|The Sofwave System, comprised of an applicator and a console, generates high intensity, non-focused ultrasonic energy which can be delivered percutaneously to tissues.
15753629|NCT04829201|Procedure|functional septorhinoplasty or oropharyngeal/orthognathic surgery|obtain pre- and postoperative data in order to describe the specific changes in airflow and upper soft tissue behavior that causes sleep apnea
15753630|NCT04829188|Behavioral|Structured Telephone Support (STS)|Structured telephone support (STS) consists of post-discharge assessment, education, and medication reconciliation delivered telephonically by a health plan case manager, home care as needed, and follow-up with the primary care within seven days post-discharge.
15753631|NCT04829188|Behavioral|Low-intensity Remote Patient Monitoring (RPM-Low)|Questions are pushed to members multiple times per week for up to 90 days post-discharge. Questions are limited to those checking vital signs that indicate worsening of infection. Patient answers to RPM questions trigger High or Medium alerts, which trigger a response by members of the intervention care team.
15753632|NCT04829188|Behavioral|High-intensity Remote Patient Monitoring (RPM-High)|Questions are pushed to members multiple times per week for up to 90 days post-discharge. Questions include monitoring vital signs for worsening infection but also ask about factors that would indicate worsening of underlying heart or lung conditions, such as weight gain or shortness of breath. Patient answers to RPM questions trigger High or Medium alerts, which trigger a response by members of the intervention care team.
15753633|NCT04829188|Behavioral|Standard Response Team|RPM alerts are screened by a nurse-staffed call center. Nurses determine whether emergency care is needed. If not, nurses contact the patient and/or the patients' PCP or specialist to coordinate care and ensure timely follow-up.
15753634|NCT04829188|Behavioral|Enhanced Response Team|RPM alerts are screened by a nurse-staffed call center. Nurses determine whether emergency care is needed. If not, the call center alerts a multidisciplinary care team that is led by a certified registered nurse practitioner (CRNP). CRNPs, who operate in a palliative care role, have prescribing authority and can modify care plans. In addition to reacting to RPM triggers, team members (e.g., CRNP, social workers, nurses) meet with the patient in-person or virtually in the week after discharge and at least twice more in the next 90 days, conduct assessments and a pharmacy review, develop care plans, and discuss advance directives.
15753635|NCT04829175|Device|Intervention|There is no intervention, beyond necessary clinical care, in this registry. The surgical procedures being performed within the registry are identical to the surgical procedures patients would receive as part of SOC.
15753641|NCT04829162|Other|Mother with obesity, son without obesity|Participants in this group were shown an image of a mother with obesity and a son without obesity.
15753642|NCT04829162|Other|Mother without obesity, son with obesity|Participants in this group were shown an image of a mother without obesity and a son with obesity.
15753643|NCT04829162|Other|Mother without obesity, son without obesity|Participants in this group were shown an image of a mother without obesity and a son without obesity.
15753644|NCT04829162|Other|Father with obesity, daughter with obesity|Participants in this group were shown an image of a father with obesity and a daughter with obesity.
15753645|NCT04829162|Other|Father with obesity, daughter without obesity|Participants in this group were shown an image of a father with obesity and a daughter without obesity.
15753646|NCT04829162|Other|Father without obesity, daughter with obesity|Participants in this group were shown an image of a father without obesity and a daughter with obesity.
15753647|NCT04829162|Other|Father without obesity, daughter without obesity|Participants in this group were shown an image of a father without obesity and a daughter without obesity.
15753648|NCT04829162|Other|Father with obesity, son with obesity|Participants in this group were shown an image of a father with obesity and a son with obesity.
15753649|NCT04829162|Other|Father with obesity, son without obesity|Participants in this group were shown an image of a father with obesity and a son without obesity.
15753650|NCT04829162|Other|Father without obesity, son with obesity|Participants in this group were shown an image of a father without obesity and a son with obesity.
15753651|NCT04829162|Other|Father without obesity, son without obesity|Participants in this group were shown an image of a father without obesity and a son without obesity.
15753652|NCT04829149|Other|Observational|Statin therapy group and Rosuzet tablet group
15753653|NCT04829136|Dietary Supplement|Nutritional Supplement Drink|Given enteral nutrition via nasoenteric feeding
15753654|NCT04829136|Dietary Supplement|Standard of Care Nutritional Support|Given standard of care, which may be parenteral nutrition
15753655|NCT04829136|Other|Survey Administration|Ancillary studies
15753656|NCT04829123|Drug|HEC88473 injection|HEC88473 will be provided as a 17 mg/mL solution and will be administered by subcutaneous injection in the abdomen
15753657|NCT04829123|Drug|Placebo|Placebo will be administered by subcutaneous injection in the abdomen
15753660|NCT04829097|Combination Product|Temozolomide|The patient received neoadjuvant temozolomide combined with simultaneous increase in intensity-modulated radiotherapy. According to data from previous clinical trials, neoadjuvant temozolomide combined with concurrently increased intensity-modulated radiotherapy PFS for 13.7 months.
15753661|NCT04829084|Behavioral|Pre-post educational intervention|To Increase the attendance of patients with Diabetes Mellitus, for retinal screening at REMEH by providing health education intervention to selected physicians and establishing a referral pathway
15753662|NCT04829071|Behavioral|Explicit motor learning|Participants will be provided with visual feedback of their right and left step lengths on a screen in front of a treadmill.
15753663|NCT04829071|Behavioral|Implicit motor learning|Participants will walk on a treadmill that drives their right and left legs to move at two different speeds.
15753664|NCT04829058|Device|Intervention|There is no intervention, beyond necessary clinical care, in this study. The surgical procedures that were performed in subjects within this study are identical to the surgical procedures the subjects would have received as part of SOC.
15753665|NCT04829045|Device|SEIRIN PYONEX Acupuncture Needles|10 press needles (PYONEX ø0.20×1.5mm made by Seirin Corporation) will be placed on abdomen area; 10 sessions over 6 weeks.
15753666|NCT04829045|Other|PYONEX Placebo|Subjects are given placebo on abdomen area; 10 sessions over 6 weeks.
15753667|NCT04829032|Procedure|Hartmann's procedure|Hartmann's procedure
15753668|NCT04829019|Radiation|Osimertinib and whole-brain irradiation|Osimertinib at a dose of 80 mg once per day, and WBI
15753669|NCT04829019|Drug|Osimertinib|Osimertinib at a dose of 80 mg once per day, until unacceptable adverse events or disease progression occurred. WBI could be given to patients in experimental arm at any time base on investigator's decision after treatment initiated.
15753670|NCT04829006|Device|Understand Me For Life|The aim of the current investigation is to test the efficacy of an app to measure sentence intelligibility in noise in speakers with Parkinson's disease and in healthy controls.
15753671|NCT04828993|Drug|tafamidis meglumine|Tafamidis meglumine 20 mg, once daily, oral administration, for 48 weeks.
15753672|NCT04828980|Device|Oculus Quest: TRIPP|This is a VR experience that focuses on meditation and mindfulness
15753673|NCT04828980|Device|Oculus Quest: Angry Birds|This is an active gaming VR experience that utilizes controllers to aim and launch objects at targets.
15753674|NCT04828967|Other|Hypnosis|Hypnosis is added to the conventional group
15753675|NCT04828954|Other|Immobilization for 2-weeks postoperative|Non-removable thumb spica plaster postoperative splint immobilization worn for 2 weeks
15753676|NCT04828954|Other|Immobilization for 6-weeks postoperative|Non-removable postoperative thumb spica splint immobilization worn for 2 weeks (+/- 3 days), to be transitioned to thumb spica cast for an additional 4 weeks (Total of 6 weeks immobilization)
15753677|NCT04828941|Device|Electronic Headache Diary|The electronic headache diary is an app-based diary that permits the registration of headaches, their acute treatment and their associated work incapacity. It also permits real-time monitoring of these data.
15753678|NCT04828941|Device|Paper Diary|The paper diary permits the registration of the same variables as the electronic diary in paper format.
15753679|NCT04828928|Procedure|electromyogram|Patients meeting the criteria will be seen in consultation with standardized interview and clinical examination. An electromyogram will be then carried out to check for the presence of neuropathy. Finally, for patients diagnosed with neuropathy, a biological check-up to look for another cause of neuropathy will be performed. In patients who already had an EMG as part of their medical follow-up, the examination will not be repeated if it strictly meets the conditions of the minimum protocol and if it was done within the year prior to inclusion. In patients who already had an identical biological assessment in the year prior to inclusion, the sample will not be taken.
15753680|NCT04828915|Other|Machine learning|Machine learning on vital parameters, clinical symptoms and underlying diseases
15753681|NCT04828915|Other|Machine based evaluation|Quantification of the prediction power and identification of the most relevant predictive parameters
15753682|NCT04828902|Procedure|cardiac surgery|Any heart surgery on or without cardiopulmonary bypass performed under general anesthesia in the Cardiac Surgical Department, Medical University of Gdańsk.
15753683|NCT04828889|Device|Anal dilators|Anal sphincter training for relaxation
15753684|NCT04828889|Procedure|lateral internal sphincterotomy|lateral internal sphincterotomy is a firmly established method for treating anal fissures.
15753685|NCT04828876|Behavioral|Yoga practice|"Yoga basically consists of breathing techniques, asanas (postures) and relaxation phases.
~Practiced Yoga Stages; 10 min. standing breathing exercise, 10 min. breathing exercise with seated asana, 10 min. lying down breathing exercise with asana, 20 min. sitting breathing exercise, 10 min. The session will be completed in 60 minutes, including deep relaxation stages by lying down. At the end of each session, patients' feedback about yoga practice will be received."
15753686|NCT04828863|Behavioral|Neurocognitive testing|Participants will undergo a battery of neurocognitive tests that examine intellectual, executive, and adaptive function. The tests will be primarily given remotely via internet-based surveys.
15753687|NCT04828850|Procedure|Endobronchial ultrasound transbronchial needle aspiration lymph node staging|EBUS-TBNA in clinical N0 NSCLC patients
15753688|NCT04828837|Device|bubble PEP|Using the bubble positive expiratory pressure (Bubble PEP) for breathing training of inpatients with COPD. The training course for one day of three times. Every time needs about 20 mins. Huff and cough after the breathing training the end.
15753689|NCT04828824|Drug|Ethinyl Estradiol / Norgestimate Oral Tablet|Those who desire COCs as an intervention are prescribed (over the phone) or given (in person) 3 packs of COCs. They are told to take one pill per day until the first pack is complete and save the remaining 2 packs for possible future use.
15753690|NCT04828798|Device|Deep brain stimulation of the VIM Thalamic nuclei|Deep brain stimulation of the thalamus, in a directional and nondirectional manner
15753691|NCT04828785|Other|MTM|weekly home meal delivery; an explanation of the medical tailoring of the meals; and a 6-session telephone lifestyle intervention change program designed to complement the period of meal delivery and prepare for the period after meal delivery with behavioral and skill-building approaches to sustain the benefit of the intervention.
15753692|NCT04828785|Other|Food Subsidy|$30/month food subsidy
15753693|NCT04828759|Behavioral|VR-treatment|The participants will be randomized either to group which receives the VR-intervention immediately (A) or to the waitlist control group (B). After the baseline assessment, the participants in the group A participate VR-intervention lasting for 8 weeks, and the participants in the group B will receive 8 weeks waitlist period. After the 8 weeks, the groups switch their places
15753694|NCT04828759|Behavioral|Treatment as usual|The participants will be randomized either to group which receives the VR-intervention immediately (A) or to the waitlist control group (B). After the baseline assessment, the participants in the group A participate VR-intervention lasting for 8 weeks, and the participants in the group B will receive 8 weeks waitlist period. After the 8 weeks, the groups switch their places
15753695|NCT04828746|Procedure|Ultrasound Guided Skin Marking|Using ultrasound for skin marking pre-procedure
15753696|NCT04828733|Procedure|Antireflux laparoscopic one anastomosis gastric bypass|Laparoscopic gastric bypass with suture cruroplasty and total wrapping of the fundus of gastric excluded part.
15753697|NCT04828733|Procedure|Standard laparoscopic one anastomosis gastric bypass|laparoscopic gastric bypass with only suture cruroplasty. Not used fundoplication.
15753698|NCT04828720|Drug|ozonated oil|All patients in ozone group were asked to visit the clinic on a daily basis through the first week and have their allocated therapeutic medication applied to their particular palatal donor site wounds. The wounds were coated with 2 ml ozonated oil per day, with a concentration of 15 µg of ozone/ml of olive oil. Moreover, palatal wounds in control group were managed by compressing the donor site with gauze and periodontal pack was placed. Patients in ozone group used a soft stent to protect the palatal donor wound site and to retain the tested oils in the post harvested palatal wounds. Patients were instructed firmly not to shatter the stent for 1 week. The stent was removed and reseated only by the operator during the application of medications and collection of smears. One week postoperatively, the protective stents were discontinued.
15753699|NCT04828707|Device|Nerivio active device|Nerivio neurostimulator of conditional pain modulation (CPM)
15753700|NCT04828707|Device|Nerivio sham device|Nerivio neurostimulator with an electrical output not intended for neurostimulation
15753701|NCT04828694|Drug|BICX104|Erodable implantable pellet containing 1 g naltrexone and 11 mg magnesium stearate.
15753702|NCT04828694|Drug|Vivitrol|Intramuscular injection containing 380 mg of naltrexone.
15753703|NCT04828681|Diagnostic Test|Cardiac magnetic resonance imaging|Cardiac magnetic resonance imaging was performed 5.0 ± 5.8 days after the primary PCI. MVO, infarct size, and myocardial salvage index were quantitatively assessed in CMR.
15753704|NCT04828668|Dietary Supplement|Targeted Wellness Formula C™ Sublingual Drops - 1200mg - 30 mL (Formula C)|Hemp seed oil
15753705|NCT04828655|Behavioral|Use of a mobile application based on machine learning with the aim of improving health and body composition parameters.|Specific diet program and moderate physical activity, all guided and mediated by a mobile application. As well as the recording and monitoring of periodic evaluations of health indicators.
15753706|NCT04828642|Dietary Supplement|Vitamin C and vitamin E|1000 mg 235 mg
15753707|NCT04828642|Dietary Supplement|Placebo|Placebo
15753708|NCT04828629|Diagnostic Test|Diagnostic tests|Selected prognostic factors will be analyzed, among others: demographic data of the patient, physical examination, symptoms, co-morbidities, results of selected laboratory tests, lung imaging (X-ray or computed tomography) selected electrocardiographic and echocardiographic data, patient's cooperation with the doctor, treatment applied, parameters in the spiroergometric study, body mass analysis.
15753709|NCT04828616|Drug|DP303c injection|DP303c injection, every 3 weeks (Q3W)
15753710|NCT04828590|Other|No intervention|Due to observational study
15753711|NCT04828577|Behavioral|Real Time Neurofeedback|Participants receive feedback from own brain activity.
15753712|NCT04828577|Behavioral|"Idealized/Sham Neurofeedback"|Participants receive idealized feedback not related to their own brain activity.
15753713|NCT04828564|Drug|Ribavirin Capsules|Ribavirin 200 mg capsules
15753714|NCT04828564|Drug|Favipiravir|Favipiravir 200 mg tablets
15753715|NCT04828551|Device|Ultrasound based shear wave speed and fat quantification methods|Ultrasound based imaging parameters will be collected from all patients in two visits. These will include but may not be limited to SWE results, Quantitative ultrasound parameters,where available,including Attenuation Coefficient, Backscatter Coefficient, Shear Wave Dispersion, Speed of Sound, Ultrasound derived fat fraction Conventional Bmode (gray-scale) and Doppler ultrasound images,including An image of the liver and right kidney on the same image for hepatorenal index calculation Right liver lobe for skin to liver capsule distance calculation Portal vein Doppler for portal vein pulsatility index measurement VCTE and Controlled Attenuation Parameter measurements with the Fibroscan system
15753716|NCT04828551|Diagnostic Test|Blood collection|"Blood will be collected by trained phlebotomists at each site using routine methods and standard collection tubes.
~Total volume is expected to be about 10 mL or less Blood collected at MGH will be analyzed by the MGH clinical laboratory. Blood collected at UCSD will be analyzed by the UCSD clinical laboratory. Blood results obtained within the 3-month interval prior to the screening visit at the MGH or UCSD laboratories will be considered acceptable for study analyses and may be used at PI discretion. For each laboratory, the normal ranges for each blood test will be recorded and filed"
15753717|NCT04828551|Other|Physical measurements|Height will be recorded at Screening. Weight and vital signs will be recorded at each visit. Body mass index will be calculated at each visit. All measurements will be made by trained coordinators using standard and calibrated instruments.
15753718|NCT04828551|Other|Clinical history and medication reviews|"The following questionnaires will be administered at Screening:
~Medical history questionnaire Medication use questionnaire Alcohol consumption questionnaire Physical activity questionnaire
~The following questionnaires will be administered at Visit 1 and Visit 2:
~Interim medical history questionnaire Change in medication use questionnaire Change in alcohol consumption will be recorded using a modified version of the alcohol use followback. Alcohol use for the 7 day period prior to Visit 1 and for all days between Visit 1 and Visit 2 will be recorded. Change in physical activity questionnaire"
15753719|NCT04828538|Dietary Supplement|Vitamin D|PO daily 4000 IU Vitamin D
15753720|NCT04828538|Dietary Supplement|Omega DHA / EPA|Po Daily 1000mg Omega DHA/EPA
15753721|NCT04828538|Dietary Supplement|Vitamin C, Vitamin B complex and Zinc Acetate|"Combination 1000 mg Vitamin C, Vitamin B complex** and Zinc Acetate, 100 mg/day
~**(Vitamin B complex components: B12=1 mg; B6=50 mg; B9=2.5 mg; B1=100 mg; B2=100 mg; B3=14 mg; B7=50 mg)"
15753722|NCT04828525|Drug|Dexamethasone|adjuvant dexamethasone treatment
15753723|NCT04828525|Drug|normal saline|placebo
15753724|NCT04828499|Procedure|Progressive Cracking Technique|Performing the cataract surgery with our phaco chop-progressive cracking technique.
15753725|NCT04828499|Procedure|Conventional Chop Technique|Performing the cataract surgery with Conventional Chop Technique.
15753726|NCT04828486|Drug|Futibatinib|Given PO
15753727|NCT04828486|Biological|Pembrolizumab|Given IV
15753728|NCT04828486|Other|Quality-of-Life Assessment|Ancillary studies
15753729|NCT04828473|Device|Allay Lamp|"The Allay Lamp is a consumer product currently available and widely used in the US. It emits low intensity (1-10lux)narrow band (20nm) green light (peak wavelength 520nm) that is marketed as non-irritating to users. In that context, it is not a medical device and does not require a 510(k). However, we believe that light likely also has benefits for sleep. To better understand its effects,we are planning to conduct the proposed study. In that context, the Allay Lamp would be considered an investigational medical device because it has not been cleared or approved by FDA for the intended purpose of treating sleep. No FDA submission should be necessary for this study using 21 C.F.R. 812.3, because the Allay Lamp is a non-significant risk (NSR) device:
~It is not an implant
~It is not intended for use in supporting or sustaining human life The Allay Lamp provides a very low risk light-based therapy. The light provides no more risk than any other table lamp available on the market today."
15753730|NCT04828447|Dietary Supplement|Olive Oil|Subjects will be randomized to either high or low dose of olive oil and follow a whole food plant based diet.
15753731|NCT04828434|Other|Virtual Individual Cognitive Simulation Therapy|Virtual Individual Cognitive Stimulation Therapy (viCST) is an individual and virtual adaptation of Cognitive Stimulation Therapy (CST), a routine psychosocial treatment for people with mild to moderate dementia in the UK.
15753732|NCT04828421|Dietary Supplement|Lactobacillus rhamnosus and Bifidobacterium lactis|Probiotics
15753733|NCT04828421|Dietary Supplement|Placebo|Placebo
15753734|NCT04828408|Procedure|Bariatric surgery|Patients with a body mass index (BMI) ˃35, age interval of 18-65, and ASA score II-III undergoing laparoscopic bariatric surgery were included in the study. Patients with neuromuscular, cardiopulmonary, and cerebrovascular diseases, phrenic nerve damage or diaphragm paralysis, those who have undergone thoracic surgery, who could not communicate, who did not want to participate in the study, who used alcohol, those who needed postoperative intensive care, those who had surgical complications during surgery, and those who were switched to open surgery were not included in the study.
15753735|NCT04828395|Biological|Camrelizumab|200mg iv Q3W
15753736|NCT04828395|Drug|Fluzoparib|150mg bid
15753737|NCT04828395|Drug|Cisplatin，Pemetrexed|Cisplatin 75mg/m2 IV and Pemetrexed 500mg/m2 IV Q3W (Day 1 of each cycle of cycles 1-3) (non-squamous cell carcinoma only)
15753738|NCT04828395|Drug|Cisplatin，Etoposide|Cisplatin 50mg/m2 IV (the 1st and 8th days of the 1st cycle and the 2nd cycle; the 8th and 15th days of the 3rd cycle); Etoposide 50mg/m2 IV (the 1st cycle And the 1st to the 5th day of the 2nd cycle; the 8th to the 12th day of the 3rd cycle).
15753739|NCT04828395|Drug|Carboplatin, Albumin Paclitaxel|Carboplatin AUC=6, Albumin Paclitaxel 100mg/m2 IV; Days 1, 8 and 15 of cycles 1, 2, and 3.
15753740|NCT04828395|Radiation|Radiotherapy|60 Gy (total 6 weeks)
15753763|NCT04828187|Diagnostic Test|Comparison of the proposed artificial network with the ground truth|"Both eyes will be included for each study participant. Participants watched a 4-10-minute video in standard mesopic environmental lighting conditions at 3.5m viewing distance. Simultaneously, all blinking moves will be recorded through a web infrared camera.
~The proposed system was tested on the 8 different subjects. Several metrics of blink detection and classification accuracy were calculated against the ground truth, which was generated by 3 independent experts, whose conflicts were resolved by a senior expert. Two independent blink identifications are assumed to be in agreement, if and only if there is sufficient temporal overlapping and the type of blink is the same between the DLED system and the ground truth."
15753741|NCT04828369|Procedure|EUS-guided coil embolization combined with endoscopic cyanoacrylate injection|(1) Standard diagnostic endoscopy was first performed. Fundal varices were assessed using the classification of Sarin's. (2) intraluminal water filling of the gastric fundus to use EUS to assess the anatomy of gastric varices, observe the blood flow, scan the portal venous system, left renal vein, confirm the location of the shunt, and measure the diameter of the shunt. (3) Punctured the gastric fundal variceal vein at the lower esophagus near the cardia and placed the coil into the shunt and immediately injected with sclerosant and cyanoacrylate under the guidance of EUS. (4) Sclerosant and cyanoacrylate were injected into the gastric fundal varices by a sandwich method (cyanoacrylate, sclerosant and cyanoacrylate) via endoscope. (5) After the injection, use color Doppler ultrasound to observe the blood flow in the variceal veins to evaluate the embolization effect.
15753742|NCT04828369|Procedure|balloon-occluded retrograde transvenous obliteration|(1)A balloon occlusive catheter was inserted into the shunt via the right femoral vein. (2)Investigators performed angiography to evaluate the size and location of GV and the shunt during balloon occlusion. Shunt was occluded by Fogarty balloon. The diameter of the balloon was chosen according to the diameter of shunt. (3)Then investigators injected sclerosant into the portosystemic shunt. (4)Finally, the balloon left in place for 24 hours was gradually deflated when complete occlusion of blood flow of the target shunt was achieved.
15753743|NCT04828356|Other|Reflexology|Reflexology application is an energy balancing system with its own pressure technique that provides recovery by rubbing the reflex (nerve endings) points, stroking and applying pressure during squeezing movements. Thanks to the pressure and massage applied to the reflex points, the energy blockages are broken and this energy flow is distributed in a balanced way to the relevant organs.
15753744|NCT04828343|Drug|rozanolixizumab|Study participants will receive a single dose rozanolixizumab subcutaneously administered by manual push or a syringe driver.
15753745|NCT04828343|Other|Placebo|Study participants will receive a single dose placebo subcutaneously administered by manual push or a syringe driver.
15753746|NCT04828317|Other|Pork Challenge|Double blind oral challenges comparing wild-type and alpha-gal free pork.
15753747|NCT04828304|Device|PLASOMA|Treatment with cold plasma device
15753748|NCT04828291|Behavioral|Benign Behavioral Interventions|This project will use a Randomized Control Trial (RCT) design and Daily Reconstruction Method (DRM8) to model the effects of the OMI on dynamic changes in first-year undergraduate and graduate students' well-being over time. The intervention will take place over the course of 46 days, with a 7- day follow up assessment taking place one month after the intervention. People will complete surveys through an online link leading to Qualtrics.com.
15753749|NCT04828278|Dietary Supplement|Arginine|Bonded Arginine Silicate
15753750|NCT04828278|Dietary Supplement|Placebo|Maltodextrin
15753751|NCT04828265|Biological|Aldafermin|Single dose of aldafermin
15753752|NCT04828252|Device|Low level laser treatment|The intervention protocol includes 2 wavelength as the experimental group, each of the were 808nm, 660nm, and 1 placebo intervention which output total power is only 0.0072W.
15753753|NCT04828239|Device|laser acupuncture|400 mW, near-infrared, continuous wavelength, 810 nm. about 24J/cm2
15753754|NCT04828239|Other|acupuncture|Needle type: C&G, gauge and size: 0.25x40mm
15753755|NCT04828239|Device|Sham laser acupuncture|This laser pen is the same device with a red light was pasted on the acu-points in the same way, using the same protocol as for the active laser stimulation, but the laser apparatus was not switched on.
15753756|NCT04828226|Drug|Clonidine|Clonidine 2mcg/kg Body Weight diluted in 100ml sodium chloride 0.9% compared to placebo (sodium chloride 0.9% alone) given over 10 minutes, 10 minutes prior to electroconvulsive therapy.
15753757|NCT04828226|Drug|Placebo|Sodium chloride 0.9% 100ml given over 10minutes, 10 minutes prior to electroconvulsive therapy.
15753758|NCT04828213|Device|Rapid Maxillary Expansion Treatment with Tooth-borne RME appliance (Hyrax)|The patients were treated with a expansion appliance containing a Hyrax expansion screw positioned parallel to the second premolars and were used to correct the posterior crossbite. RME activation was performed twice a day for the first week and then once per day. When it was decided that the expansion was sufficient (until the palatal tubercles of the upper molars came into contact with the buccal tubercles of the lower molars), the screw was fixed with the 0.012-inch ligature wire (American Orthodontics) and the appliance was kept in the mouth without being activated for 3 months.
15753759|NCT04828213|Device|Rapid Maxillary Expansion Treatment with Hybrid hyrax RME appliance|The patients were treated with a Hybrid hyrax RME appliance containing a Hyrax expansion screw positioned parallel to the second premolars and mini-screws. RME activation was performed twice a day for the first week and then once per day. When it was decided that the expansion was sufficient (until the palatal tubercles of the upper molars came into contact with the buccal tubercles of the lower molars), the screw was fixed with the 0.012-inch ligature wire (American Orthodontics) and the appliance was kept in the mouth without being activated for 3 months.
15753760|NCT04828200|Diagnostic Test|Musculoskeletal ultrasound|The ultrasonographic assesment will be used to examine the rectus femoris, gastrocnemius medailalis and rectus abdominis subcutaneous and muscle thickness. Additionally, fascicle length and pennation angle were measured between the two parallel aponeuroses of the gastrocnemius muscle (bulkiest part of medial head) in the longitudinal view when subjects were in prone position with their ankles at 90°.
15753761|NCT04828200|Diagnostic Test|Dual-X-ray absorptiometry|The muscle masses of the patients were evaluated by measuring the fat mass (Fat Mass-FM), fat mass index (FMI), lean body mass (LBM) and skeletal muscle index (SMI) calculated by DEXA. Appendicular muscle mass (ASM) is calculated by summing the lean soft tissue of the two upper limbs and the two lower limbs. Skeletal muscle mass index is calculated by dividing the appendicular lean mass by the square of the neck height [SMI = ASM / height2 (kg / m2)].
15753762|NCT04828200|Diagnostic Test|Isokinetic dynamometer|Quadriceps-hamstring Peak Torque (PT) values and the ratio of PT values to body weight (PT / VA) (at 60 and 180 ° / sec speeds) were evaluated with an isokinetic dynamometer
15753764|NCT04828174|Drug|anti-TRBC1 CAR-T cell therapy|TRBC1 positve patients with relapsed or refractory T cell malignacy will receive CAR-T cell therapy targetting TRBC1
15753767|NCT04828148|Behavioral|Survey|An online survey made by the authors was used, which is comprised of a total of 48 questions where different types of information are distinguished regarding the participant who is answering it such as age, gender, medical degree, comorbidities if during the pandemic they have been in contact with patients suspected or confirmed of COVID-19 infection if they have been infected by COVID-19 and the outcome of this infection. It also refers to whether they know doctors in the same specialty or others who have died from COVID-19 infection.
15753768|NCT04828135|Drug|Hyperpolarized 129Xenon gas|Each xenon dose will be limited to a volume less than 25% of subject lung capacity (TLC),
15753769|NCT04828109|Device|Virtual Reality|Use of any virtual reality experiences available
15753770|NCT04828109|Device|Fitbit|Use of a Fitbit wearable activity device to track daily step goals.
15753771|NCT04828096|Other|Orthodontic retention|The stability of the mandibular anterior teeth after two resp. 5 years of retention
15753772|NCT04828083|Drug|Lidocaine IV|Intravenous lidcaine of 1.5 mg/kg bolus followed by a 1.5 mg/kg/h infusion continuing to the end of phase 1 of post anesthesia care unit
15753773|NCT04828083|Drug|Saline IV|Intravenous saline of 1.5 mg/kg bolus followed by a 1.5 mg/kg/h infusion continuing to the end of phase 1 of post anesthesia care unit
15753774|NCT04828070|Other|Observation|all participants followed for clinical data for one year, vital status check at 5 years
15753775|NCT04828057|Drug|Tafluprost, timolol maleate|Patients prescribe PG mono who occurs OSD or I IOP lower insufficient. patients switch to combination therapy.
15753776|NCT04828044|Device|Microwave Ablation/ Coagulation Arm|An 11-gauge microwave probe from MedWaves, Inc., will be placed in the tumor. An ablation lesion will then be generated at the appropriate power (10-35 watts) to maintain up to 130C degrees at the MW applicator tip thermocouple for 10 minutes duration. Palpation and/or ultrasound may be used to place the MWA needle and monitor the progress of the microwave ablation.
15753777|NCT04828031|Drug|Vitamin D|Patient with inflammatory bowel disease who have low vitamin D (25(OH)D less than or equal to 25 ng/mL) will take Vitamin D 50,000 IU by mouth every week for 12 weeks. Patients will fill out questionnaires to document disease activity score (HBI or Mayo score and sIBDQ) and have blood and stool samples collected before (Week 0), during (Week 8) and after (Week 12) vitamin D intervention.
15753778|NCT04828018|Other|Coffee Morning|Coffee mornings (a maximum of n=2) will be held to raise awareness of the project and to promote participant recruitment. These will be held remotely via video conference if Covid-19 restrictions prevent in-person attendance by the researcher.
15753779|NCT04828018|Other|Recruitment Leaflets|Recruitment leaflets will be hand-delivered to all In-Pensioner residents at Royal Hospital Chelsea. Leaflets will be delivered internally by Royal Hospital Chelsea internal mail-room
15753780|NCT04828018|Other|Consent Form completion|All participants will be asked to complete Consent Forms before engaging in the study. The researcher will be available to answer any questions via phone calls if required.
15753781|NCT04828018|Other|Participant Information Sheet|All participants will receive Information Sheets which they will read in their own rooms (or elsewhere for Key Staff). The researcher will be available to answer any questions via phone calls if required.
15753782|NCT04828018|Other|New In-Pensioner Resident Information Pack|New In-Pensioner resident information packs will be distributed by a member of RHC staff as part of their 'arrivals' process and six months after residency at RHC. The researcher will be available to answer any questions via phone calls if required.
15753783|NCT04828018|Other|Key Staff Interviews|Key Staff interviews will take place with the Researcher in a private space at Royal Hospital Chelsea. If Covid-19 restrictions are in place, 'online' interviews will take place using a digital platform such as 'Skype', 'Teams' or 'Zoom'.
15753784|NCT04828018|Other|In-Pensioner Resident Interviews|In-Pensioner resident interviews will take place with the Researcher in a private space at Royal Hospital Chelsea. If Covid-19 restrictions are in place, 'online' interviews will take place using a digital platform such as 'Skype', 'Teams' or 'Zoom'.
15753785|NCT04828018|Other|ICECAP-A Quality of Life Questionnaire|New In-Pensioner residents and In-Pensioner residents taking part in the Qualitative Interviews will be asked to complete n=2 QoL questionnaires. New In-Pensioners will be asked to complete their QoL measures when the individual takes up residence at Royal Hospital Chelsea, the second six months later. In-Pensioner residents taking part in the interviews will be asked to complete the questionnaire at the start of the interview.
15753786|NCT04828018|Other|WHOQOL-BREF Quality of Life Questionnaire|New In-Pensioner residents and In-Pensioner residents taking part in the Qualitative Interviews will be asked to complete n=2 QoL questionnaires. New In-Pensioners will be asked to complete their QoL measures when the individual takes up residence at Royal Hospital Chelsea, the second six months later. In-Pensioner residents taking part in the interviews will be asked to complete the questionnaire at the start of the interview.
15753789|NCT04827992|Drug|Medical Marijuana|Patients in this group can choose what type, how much, and when to use medical marijuana to use.
15753790|NCT04827992|Behavioral|Prescription Opioid Taper Support (POTS)|Prescription Opioid Taper Support (POTS), a manualized behavioral prescription opioid taper support intervention developed by consultant, will be offered weekly to all participants to support behavioral self-management of pain and structured, voluntary taper of COT dose.
15753791|NCT04827979|Biological|daratumumab|"Daratumumab is a CD38 (Cluster of Differentiation 38)-directed cytolytic monoclonal antibody indicated for the treatment of multiple myeloma. In this study, daratumumab will be used in highly sensitized subjects without myeloma who are awaiting a kidney transplant.
~Definition of highly sensitized: Potential kidney transplant recipients with either:
~calculated panel reactive antibodies (cPRA) ≥99.9% awaiting deceased donor transplant, or
~cPRA >98% (with >5 years of waiting time) awaiting living donor transplant"
15753792|NCT04827979|Biological|belatacept|Belatacept, a monoclonal antibody, is indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant. In this study, belatacept will be used in subjects who have not received a kidney transplant.
15753793|NCT04827979|Procedure|Bone marrow aspiration|Subjects will undergo a bone marrow aspiration prior to starting the study regimen and at 12 weeks after starting the study regimen. In subjects who undergo a kidney transplant during the study, another bone marrow aspiration will be done if it has been >4 weeks since the previous bone marrow aspiration.
15753794|NCT04827966|Other|Clinpro® 5% sodium fluoride plus tri calcium phosphate varnish|Clinpro® is 5% sodium fluoride varnish and is indicated to be used for hypersensitive as well as for demineralized teeth. It flows smoothly on moist teeth and binds firmly to their surfaces. 1ml of Clinpro® contain 50 mg of sodium fluoride
15753795|NCT04827966|Other|Tooth Mousse® - Casein phosphopeptide-Amorphous calcium phosphate (CPP - ACP)s|Tooth Mousse® contains Casein phosphopeptide-Amorphous calcium phosphate (CPP - ACP) is product from the milk casein. This delivers the necessary Calcium and Phosphate ions to the tooth, which will reduce the risk of caries and white spot by enhancing tooth remineralization.
15753796|NCT04827966|Other|MI Paste® -Casein phosphopeptide-Amorphous calcium phosphate fluoride (CPP-ACPF)|MI Paste® which is Casein phosphopeptide-Amorphous calcium phosphate fluoride (CPP-ACPF) additional contains fluoride in addition to CPP-ACP. The level of fluoride is 900ppm which approximates that in adult strength toothpastes.
15753797|NCT04827966|Other|Zap® 1.23% APF gel - Acidulated phosphate fluoride|1.23% APF (Acidulated phosphate fluoride) gel is routinely used professional based fluoride for patients with high caries risk.
15753798|NCT04827966|Other|Listerine fluoride mouthrinse|Listerine® Sodium fluoride (0.2%) mouth rinses are effective in reducing caries and inhibit carbohydrate utilization of oral microorganisms by blocking enzymes involved in the bacterial glycolytic pathway studies have shown sodium fluoride mouth rinse to be effective in reducing S. mutans counts
15753803|NCT04827940|Other|Progressive relaxation exercise with music|"The progressive relaxation technique includes exercises for the muscles in the body to consciously contract and relax together with deep breathing exercises while sitting comfortably or lying down accompanied by music.
~Relaxing relaxation music for sleep, prepared by the Turkish Psychologists Association, has been installed on the mobile phones of the patients.
~The patients did the relaxation exercises for an average of 30 minutes before going to bed for a week and every day with music.Relaxing relaxation music for sleep, prepared by the Turkish Psychologists Association, has been installed on the mobile phones of the patients.
~The patients were taught to do the relaxation exercises for an average of 30 minutes before going to bed for a week and every day with music."
15753804|NCT04827927|Procedure|Procedure: INTELLiVENT-ASV|With INTELLiVENT-ASV, the patient's conditions, 'ARDS', 'Chronic Hypercapnia' or 'Traumatic Brain Injury' can be chosen, if applicable. The controllers for minute volume, PEEP and FiO2 are all activated, and the target shifts for etCO2 and SpO2 are adjusted, if necessary.
15753805|NCT04827927|Procedure|Procedure: Conventional ventilation|With conventional ventilation, the same etCO2 and SpO2 levels are targeted as with INTELLiVENT-ASV, but here the caregiver is fully responsible for choosing the settings.
15753806|NCT04827914|Behavioral|Enhanced Care|Smokers in the enhanced care group will receive live counseling (either in person or telehealth consult) while hospitalized combined with post-hospital discharge automated calls using interactive voice recognition (IVR) technology.
15753807|NCT04827914|Behavioral|Basic Care|Smokers assigned to the basic care group will only receive the post-discharge IVR phone calls.
15753808|NCT04827901|Drug|XEN1101|two 10 mg capsules
15753809|NCT04827901|Drug|Placebo|matching placebo
15753810|NCT04827888|Procedure|Orthopaedic surgery|One of the 25 most common orthopedic surgeries reported in the database which are the following as per surgical types: spine surgery (CPT codes 63030, 63047, 22612, 22551 or 22558), trauma (CPT codes 27236, 27125, 27244, 27814, or 27792), sports medicine injuries (CPT codes 29881, 29827, 29880, 29888, 29826, 29877, 29807, or 23412), or joint arthroplasty (CPT codes 27447, 27130, 23472, 27487, 27134, 27446, or 27486).
15753811|NCT04827875|Drug|AIV001|Intradermal
15753812|NCT04827862|Drug|Pembrolizumab|pembrolizumab plus low-dose (4 Gy x 5) involved-site radiotherapy
15753813|NCT04827849|Other|Structured education and follow-up|"The women in the intervention groups will administer a seven-session intervention program in addition to the routine care they will receive.
~The training including preparation practices for the transition with the mother, which is planned to last for 7 weeks encompassed providing the women with an educational programme that were created to increasing women's adaptation to motherhood and perceptions of newborn baby
~Nursing-recommended follow-up and physical examination of the pregnant woman will be performed at 28th and 34th week of pregnancy. In addition, postpartum and newborn follow-up, and mother-newborn physical examinations will be performed at the postpartum period."
15753814|NCT04827836|Procedure|Cooled eye drops and povidone-iodine|Cooled oxybuprocaine HCl 0.4% and lidocaine HCl 2% eye drops and cooled povidone-iodine (cul-de-sac 5% povidone-iodine and 10% povidone-iodine).
15753815|NCT04827823|Other|Retrospective evaluation of amalgam and composite restorations|Multi-surface restorations that were performed by dental students and that are in function for the last five years will be clinically evaluated with mirrors and probes according to the modified USPHS criteria.
15753816|NCT04827810|Drug|Gamitrinib|This is a first-in-human, phase I, open-label, non-randomized dose-escalation and dose-expansion study with the primary objective to determine the safety profile of small molecule, mitochondrial-targeted Hsp90 inhibitor, gamitrinib, including identification of dose-limiting toxicities (DLT) and maximum tolerated dose (MTD) in patients with advanced cancers. A secondary objective of the study is to determine the recommended dose and regimen(s) for a phase II study. This study is based on preclinical data demonstrating the anticancer activity, unique mechanism of action and preliminary safety of gamitrinib.
15753817|NCT04827797|Device|balls|Birth balls to exercise
15753818|NCT04827784|Procedure|local anaesthetic injection|The head and neck of the condyle were detected by palpating the pretragal area. Then, the needle was inserted anterior to the junction of the tragus and the lobule. After 0.5 ml the solution was subcutaneously infiltrated, the needle was protruded until it touched the neck of the condyle. Aspiration was performed to avoid intravenous injections, and the remaining solution was injected thereafter.
15797216|NCT04474301|Other|Survey Administration|Complete survey
15753819|NCT04827758|Procedure|Screening and diagnostic tests for sarcopenia|"All of the following tests and questionnaires will be performed :
~SARC-F questionnaire,
~measurement of muscle strengh by a grip test,
~measurement of muscle mass by impedancemetry (ASM/size2),
~4-meter walking speed test,
~Timed-Up and Go (TUG) test,
~ADL (Activities of Daily Living) and IADL (Instrumental Activities of Daily Living) questionnaires."
15753820|NCT04827745|Drug|BLINCYTO (Blinatumomab)|Blinatumomab (BLINCYTO , AMG 103, formerly also known as MT103 or bscCD19xCD3) is a novel single chain antibody construct in the class of the bispecific T-cell engager (BiTE®). Blinatumomab directs CD-3 positive effector memory T cells to CD19-positive target cells (Hoffmann et al, 2005; Dreier et al, 2002). The targeted CD19 antigen is constitutively expressed on normal B cells throughout a person's lifetime (Smet et al, 2011) and is highly conserved in B-cell malignancies (Tedder, 2009; Wang et al, 2012).
15753821|NCT04827732|Radiation|Hypofractionated Pencil-Beam Scanning Intensity-modulated Proton Therapy|When feasible it is strongly recommended that radiotherapy begin on a Monday
15753822|NCT04827732|Device|MEVION S250i Hyperscan and Adaptive Aperture Proton Therapy Machine|-The device that will administer the IMPT
15753823|NCT04827719|Drug|BST-236|Recurrent 6 days treatment courses with BST-236 (4.5 g/m2/d administered IV over 1 hour for 6 consecutive days)
15753824|NCT04827680|Device|Venus Viva|The Venus Viva™ fractional RF device has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.
15753825|NCT04827667|Diagnostic Test|bronchoalveolar lavage|Bronchoalveolar lavage is performed by instillation and suction of saline in the middle lobe during bronchoscopy. Cytological examination and flow cytometry will be performed to assess PD-1lymphoctes.
15753826|NCT04827654|Dietary Supplement|Weekly produce box and gift card|Weekly box of produce (5-10 lbs) and $10.00 gift card to a local grocery store to purchase preferred produce. If progress on self-goals completed, an additional $10.00 card provided, weekly, for 3 weeks.
15753827|NCT04827641|Other|Severity Grading assessment in children with perioperative unexpected events|Systematic documentation of all unexpected events was carried out by designated team members during daily routine team conferences. Briefly, on-call team members and all other staff reported on any unexpected event that had occurred within the previous 24 hours, after weekends during the past 72 hours. Events included those that had occurred in inpatients, outpatients and in the pediatric emergency department. Data concerning each event included patient demographics, diagnoses, treatments/operations and types of events.
15753828|NCT04827628|Dietary Supplement|Oryza Sativa Extract|The product is a suspension of 5.6 gram/100 mL given once daily, contains 71.9%, purple in color, range pH 3-5. Stored in the darker bottle. The frequency of administration is once-daily after the meal.
15753829|NCT04827628|Dietary Supplement|Control|citric acid 0.1g/oz and 1% sorbitol mixture, given once daily after meal
15753830|NCT04827615|Behavioral|Ambuja Cement Foundation's Non Communicable Disease Program|"Government level: Strengthening linkages with Govt; Ensuring availability & affordability of NCD diagnostics and treatment; Establishing a follow-up mechanism with patients to ensure continuity of care & medication compliance
~Provider level: Capacity building of frontline workers; Promotion of interface between community & service provider
~Community level: Screening of hypertension & diabetes for all adults ≥30 years in the village in coordination with Govt under 'population based screening'; Create awareness of modifiable risk factors and lifestyle change among high-risk population; Community mobilization & active participation in various health marker days; Formation of support groups, women's groups, SHG groups, with involvement of people living with NCDs
~Individual level: Behavior change communication with messages on NCD risk factors; Nutrition awareness on healthy and unhealthy food practices"
15753831|NCT04827602|Other|Drug allergy label status in electronic health records|Registered drug allergy labels in primary care and hospital electronic medical charts
15753832|NCT04827589|Drug|Tirabrutinib|Tablets administered orally
15753833|NCT04827589|Drug|Placebo|Tablets administered orally
15753836|NCT04827563|Device|EndoPAT|An FDA approved device to test the health of a patient's blood vessels, which involves putting an oxygen probe on the participant's finger.
15753837|NCT04827563|Device|Blood Pressure Cuff|A device used to conduct blood pressure monitoring using a home blood pressure cuff that participant wears for 24 hours.
15753838|NCT04827563|Diagnostic Test|Echocardiogram|A test used to conduct an ultrasound of participant's heart.
15753839|NCT04827563|Other|Quality of Life Assessment|A survey that will be given to participants to report their quality of life and symptoms related to multiple myeloma.
15753840|NCT04827563|Other|Blood Tests|Routinely collected for all participants who begin carfilzomib treatment.
15753841|NCT04827550|Other|STUDY|Fibromyalgia Patient
15753842|NCT04827537|Drug|20-hydroxyecdysone Oral|100 mg (one pill) x two times a day orally, 10 consecutive days
15753843|NCT04827537|Drug|Metronidazole Oral|500 mg (one pill) x two times a day orally, 10 consecutive days
15753844|NCT04827537|Drug|Placebo Oral|100 mg (one pill) x two times a day orally, 10 consecutive days
15753845|NCT04827524|Other|Anthropometric measurement|The demographic information and birth histories of the subjects included in the study will be taken first. Anthropometric measurements of all subjects will be measured with the Star Scanner device. The Star Scanner 3 dimensional data collection system is a scanning system that enables the anthropometric head measurements of the baby to be taken in just 2 seconds. The advantages of this device is that it does not emit any harmful beams during evaluation, it does not have any harmful effects on health, and that it is an application that will not disturb babies.
15753846|NCT04827511|Other|Refraction measurement with auto-ref-keratometer Canon|Refractive measurement and vitamin D level dosing
15753847|NCT04827498|Diagnostic Test|Invasive coronary endothelium-dependent and non-endothelium-dependent physiological assessment|Coronary hemodynamics and vessel anatomical measures obtained during adenosine and acetylcholine evaluation with a dedicated physiology wire
15753909|NCT04826965|Device|Wound Vac is applied|A wound vac or wound vac with cleanse choice dressing, track pad duo, and saline irrigation is applied.
15753850|NCT04827472|Drug|Normal saline|100ml
15753851|NCT04827472|Drug|DWJ1521|Single dose
15753852|NCT04827472|Drug|DWP14012 Tablet|Single dose, Tablet
15753853|NCT04827459|Behavioral|Sleep Coach App|Participants will be encouraged to interact with the mobile app daily for as much time as they wish, or for as little as 5 - 10 minutes, over a 7-week period.
15753854|NCT04827446|Other|Wearable Sensor|Patient is given a wearable device to wear for 12 weeks.
15753855|NCT04827446|Other|Blue-blocking glasses|Patient is given blue-blocking glasses to wear at instructed times.
15753856|NCT04827446|Other|Clear glasses|Patient is given glasses that block no visible light.
15753857|NCT04827446|Other|Full SYNC app|Patient downloads the SYNC app and is given light interventions designed to have a targeted, personalized effect on the circadian clock.
15753858|NCT04827446|Other|"Dummy SYNC app"|Patient downloads the SYNC app and is given light interventions designed to have minimal impact on the circadian clock.
15753859|NCT04827420|Behavioral|Mi Quit Care|Demonstrating the feasibility, effectiveness, and cost-effectiveness of electronically delivered smoking cessation interventions via patient portals in Federally Qualified Health Care (FQHC) settings has the potential for wide-spread dissemination and significant public health impact. on patient populations with demonstrated high rates of smoking.
15753860|NCT04827407|Device|Efferon LPS hemoperfusion|Hemoperfusion using continuous extracorporeal LPS adsorption with Efferon LPS therapeutic device during a period of 24h immediately following admission to the intensive care unit
15753861|NCT04827394|Device|Neonatal warming mattress|Babies will be warmed with a standard neonatal transport warming mattress immediately after birth.
15753862|NCT04827394|Device|Sterile polyethylene wrap|Babies will be wrapped in a sterile polyethylene wrap prior to arrival at the warmer.
15753863|NCT04827381|Other|Annotated Audio|In addition to usual care, patients will be given access to an annotated audio-based PHL, HealthPal to listen to outside of the clinic. HealthPAL will allow participants to replay the audio recording of their clinic visit which will be annotated with key information discussed (e.g., medications). The recording will also contain hyperlinks related to annotations, that will direct participants to the online health information resource at Medline Plus. Access to their HealthPAL can also be shared with a caregiver.
15753864|NCT04827381|Other|Audio|In addition to usual care, patients will also be given access to an audio-based PHL, HealthPal to listen to outside of the clinic. HealthPAL will allow participants to replay the audio recording of their clinic visit (no annotations or hyperlinks). Access to their HealthPAL can also be shared with a caregiver.
15753865|NCT04827368|Other|Breath Test|Research Breath Test
15753868|NCT04827342|Other|data collection in the Ada DDSS prototype|Entry of patients' data (medical history, symptoms and findings) in the Ada DDSS prototype. The tool then automatically creates a list of possible diagnostic suggestions based on the information, which are compared with the diagnoses of the attending physician.
15753869|NCT04827329|Other|Questionnaire|Patients will complete a questionnaire regarding their anesthesia history, course and possible complications, and Questions about their treatment for their sleep disorder.
15753870|NCT04827303|Other|Kinesio taping|A 10-15 cm sized I band was applied to the trapezius muscles of the first group patients with the patient's neck in lateral flexion. Then, while the patient's neck is flexed, a Y-shaped 15-20 cm tape will be affixed between C1-7 with the arms of the Y up, and I tape of 5-10 cm is attached on the arms. In group 2 patients, 1 cc lidocaine diluted with 4 cc saline (SF) was applied to the trigger points palpated manually in the trapezius muscles. After the trigger point was squeezed between the thumb and index finger, a few cc of local anesthetic mixture was applied into the trigger point with the injector and exited. In the 3rd group patients, a few cc local anesthetic mixture will be applied intradermally over the trigger point without entering into the trigger points palpated manually in the trapezius muscles. Patients were checked 72 hours and 1 week after the first applications.
15753871|NCT04827290|Behavioral|Low-AGE diet|Low-AGE diet during 24 months
15753872|NCT04827290|Behavioral|High-AGE diet|High-AGE diet during 24 months
15753873|NCT04827277|Procedure|Reverse Total Shoulder Replacement|Participants will be randomized to a reverse total shoulder replacement
15753874|NCT04827277|Procedure|Anatomic Total Shoulder Replacement|Participants will be randomized to an anatomic total shoulder replacement
15753875|NCT04827264|Diagnostic Test|Safe Return to Play Following ACL Reconstruction Checklist|"All participants who have undergone primary ACL reconstruction will receive PT evaluation using our Return to Play Checklist at 7 months post-op, prior to return to sports"
15753876|NCT04827251|Dietary Supplement|Coffee|"Participants will receive Nespresso coffee maker Essenza model. The coffee Nespresso blend voluto will be provided (caffeinated and decaffeinated). The patients will have to take four cups of espresso per day (three cups a day for patients aged 65 and over)."
15753877|NCT04827238|Diagnostic Test|Standardized Invasive Hemodynamics|The SIH technique is a standardized, reproducible and efficient way of obtaining hemodynamic measurements.
15753878|NCT04827225|Behavioral|questionnaires|Questionnaires (EPDS, HADS, PPQ, MIBS, etc.) will have to be completed by the parents at different stages of their child's development (38 weeks of amenorrhea, 3 months and 24 months).
15753879|NCT04827212|Behavioral|Companion|"Companion integrates wearable sensing with the smartphone to develop a behavior-aware, virtual system that uses a human-in-the-loop approach to enable meaningful two-way communication. Companion builds rich models of typical behavior using sensors and context sensitive ecological momentary assessment to deliver intervention components and behavior change strategies using socially engaging, contextually salient, and tailored text-message conversations in near-real-time."
15753905|NCT04827004|Drug|Anlotinib Hydrochloride Capsules|Anlotinib capsules given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
15753906|NCT04826991|Device|Active UV Device|Active water treatment system
15753880|NCT04827199|Device|Artificial Urinary Sphincter implantation|"Device preparation (recharge, settings, pairing) Patient preparation Calibration procedure (to verify the device is in full working prior to implantation)
~Implantation procedure which includes:
~Perineal approach and bulbar urethral dissection
~Inguinal approach
~Cuff implantation around the urethra
~Transmission cable passing
~Surgery test procedure
~Implantation of the Control Unit
~Closure of the inguinal incision
~Closure of the perineal incision
~Implant disabled mode activation"
15753881|NCT04827186|Procedure|Spleen Transplantation/Removal|Spleen transplantation/removal and kidney transplantation alone or simultaneous kidney and pancreas transplantation in highly sensitized patients with either a positive flow cytometry cross-match (FCXM) (T or B cell positive) or a complement-dependent cytotoxicity (CDC) cross-match (B cell positive).
15753882|NCT04827173|Procedure|transcutaneous medium-frequency alternating current|Patients receive nerve block of right forearm through transcutaneous medium-frequency alternating current
15753883|NCT04827147|Device|Multi-Periscopic Prism (MPP) glasses|Spectacles with multi-periscopic prisms mounted as oblique peripheral prism segments
15753884|NCT04827147|Device|Fresnel Peripheral Prism (FPP) glasses|Spectacles with conventional permanent Fresnel prisms mounted as oblique peripheral prism segments
15753885|NCT04827134|Drug|TRIUMEQ|TRIUMEQ will be available as fixed dose combination (FDC) dispersible tablets to be administered orally as a dispersion.
15753886|NCT04827134|Drug|DOVATO|DOVATO will be available as FDC dispersible tablets to be administered orally as a dispersion.
15753887|NCT04827121|Procedure|Fascial iliac compartment block|Patients will recieve supra-inguinal approach of fascial iliac compartment block under ultrasound guidance with 30 ml of 0.5 percent ropivacaine.
15753888|NCT04827121|Procedure|Quadratus lumborum block|Patients will recieve transmuscular approach of quadratus lumborum block under ultrasound guidance with 30 ml of 0.5 percent ropivacaine.
15753889|NCT04827108|Other|PeNAT validation|Children will be required to fill in a set of questionnaires including the Chinese version of the Pediatric Nausea Assessment Tool (PeNAT), the Chinese version of the Pediatric Quality of Life Inventory 4.0 Cancer Module (PedsQL 4.0), and the Chinese version of Center for Epidemiological Studies Depression Scale for Children (CES-DC)
15753890|NCT04827095|Other|Web-Based Support and Education Program 1|The classes will discuss topics related to caregiving for someone with a spinal cord injury. During these classes, participants will be given information by the class instructor and will also participate in discussions and other learning activities with the rest of the group. Participants will be assigned activities to complete at home for about one hour per week that relate to the topics discussed in class.
15753891|NCT04827095|Other|Web-Based Support and Education Program 2|The classes will discuss topics related to caregiving for someone with a spinal cord injury. During these classes, participants will be given information by the class instructor and will also participate in discussions and other learning activities with the rest of the group. Participants will be assigned activities to complete at home for about one hour per week that relate to the topics discussed in class.
15753892|NCT04827082|Other|Diacutaneous fibrolysis|Diacutaneous fibrolysis is a physiotherapeutic instrumental technique, used to treat musculoskeletal conditions causing pain and/or movement restriction. It is applied by means of metallic hooks, ending in a spatula with beveled edges. Regardless of its own dominance, diacutaneous fibrolysis will be applied to de following muscles and intermuscular septums: gluteus maximus, biceps femoris and semitendinosus to de lower experimental limb. A single session of 10 minutes will be applied.
15753893|NCT04827069|Drug|Clifutinib Besylate|receive oral Clifutinib Besylate once daily until disease progression or unacceptable toxicity occurs, each cycle is defined as 28 days
15753894|NCT04827056|Drug|Placebo|Placebo will be administered orally, as individual films in the SL space.
15753895|NCT04827056|Drug|Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 40µg|BXCL 501 40µg will be administered orally, as individual films in the SL space.
15753896|NCT04827056|Drug|Dexmedetomidine (DEX) for sublingual (SL) administration (BXCL501) - 80µg|BXCL 501 80µg will be administered orally, as individual films in the SL space.
15753897|NCT04827056|Procedure|Ethanol Infusion|Study team will be using a modified alcohol-IV clamp procedure developed and standardized by Subramanian and colleagues (Subramanian, Heil et al. 2002). The infusion will be performed using a 6% ethanol solution in 0.9% saline. The computer assisted administration program automatically calculates and corrects the infusion rate based on real-time BrAC data entry by staff, based on the pharmacokinetic profile of each subject (targeting a breath alcohol concentration (BrAC) of 100 mg%).
15753898|NCT04827056|Behavioral|PTSD Reactivity Condition|Participants will be exposed to two conditions in random order: PTSD cues and neutral cues. The cues will consist of a 5 minute presentation of the stimulus (trauma or neutral) followed by immediate evaluation of craving and anxiety. There will be a relaxation procedure between each condition. The imagery scripts are developed based on the scene construction questionnaire developed by Lang et al (Lang, Kozak et al. 1980, Lang, Levin et al. 1983) using a standardized format designed by Sinha (Sinha 2001).
15753899|NCT04827056|Behavioral|Alcohol Cue Reactivity|Participants will be exposed to two conditions: a neutral cue (water) followed by an alcohol cue. Individuals will be instructed that they may smell and handle the beverage, but they cannot consume the beverage. Following the presentation, the research assistant takes the beverage and leaves the room, while the subject completes the anxiety and alcohol craving assessments.
15753900|NCT04827043|Combination Product|Ultrasound guided quadratus lumborum block|prospective randomized comparative study between Group (1) : quadratus lumborum block
15753901|NCT04827043|Combination Product|Ultrasound guided thoracic paravertebral block|PVB group: will receive 0.25ml/Kg/side of 0.375% bupivacaine with epinephrine 5ug/ml, yielding the same dose of bupivacaine of 1.875mg/ml at the level of T10 as a single injection sonar guided.
15753902|NCT04827030|Drug|Ropivacaïne Hydrochloride by Erector Spinae block|Ropivacaïne Hydrochloride Erector Spinae puncture will be performed with ultrasound guidance. Then 0.50% Ropivacaine hydrochloride will be injected at a dose of 0.6 ml/kg of actual weight, without exceeding 30 ml.
15753903|NCT04827030|Drug|Ropivacaïne Hydrochloride by Paravertebral block|Paravertebral puncture will be performed with ultrasound guidance. Then 0.50% Ropivacaine hydrochloride will be injected at a dose of 0.6 ml/kg of actual weight, without exceeding 30 ml.
15753904|NCT04827017|Other|follow up|follow up population
15753907|NCT04826991|Device|Inactive UV Device|Inactive water treatment system
15753910|NCT04826952|Procedure|Orchiectomy|Childhood testicular tumors deserve special diagnostic attention from the therapeutic point of view. A testicular tumor should be considered malignant until proven otherwise. In cases with suspicion of testicular tumors, the inguinal approach is preferred to the scrotal approach for scrotal violation.
15753911|NCT04826939|Device|PFDx device and leva device|Participants will use the leva device, PFDx device and undergo ultrasound measurements during pelvic floor motion to compare the three measurements.
15753912|NCT04826926|Procedure|Procedure/Surgery: Non Surgical Periodontal Therapy|"Conventional staging debridement (CSD) according to the severity of periodontal disease in 2 to 4 appointments at day 0, 7, 14 and 21.
~Supra and subgingival scaling and polishing will be performed by the use of manual and ultrasonic instruments and oral hygiene instructions will be given. Patients will be instructed to use interdental brushes with appropriate size interdental brushes or dental floss when interdental embrasures will not allow for interdental brushing."
15753913|NCT04826913|Device|Organoids|"Use of an innovative device to improve the management of patients with NSCLC for precision medicine.
~The different drugs used can be conventional chemotherapy (cisplatin, carboplatin, pemetrexed), targeted therapies or immunotherapy molecules. It is also planned to use radiotherapy on our drug testing device."
15753914|NCT04826900|Procedure|BoNT-A injections|Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide. The total dose range is 200 units to 500 units. The dose range of each target muscle is as below: 20 and 75 units for flexor carpi ulnaris and flexor carpi radials; 12.5-35 units per fascicle in the flexor digitorum sublimis and flexor digitorum profundus (maximum dose: 120 units for each of these muscles); 10-35 units in the flexor pollicis longus; 25-100 units in the brachioradial ; 50-200 units in the biceps brachii; and 25-75 units in the pronator teres
15753915|NCT04826900|Other|Robotic therapy (RT)|A wearable robotic hand system will be used in this study. The robotic hand system consisted with a wearable exoskeletal hand, sensor glove, and a control box. On the exoskeletal hand, there are five actuators on each of finger structure that can provide external power to bring individual finger moving. The sensor glove has five sensors that can detect the finger's posture during movement and then manipulates exoskeletal hand via the control box. The patient's unaffected hand wears the sensor glove, the affected hand wears the wearable exoskeleton hand, and the unaffected hand does the certain transitive and intransitive tasks as the mirror group, and then makes the affected hand do the same movements driven by the exoskeleton robotic hand.
15753916|NCT04826900|Other|Robotic mirror therapy (RMT)|Wearable robotic hand system and mirror system will be used in this group.. The patients in the group will wear the robotic hand to do the mirror therapy. The patient's unaffected hand wears the sensor glove, the affected hand wears the wearable exoskeletal hand, a mirror box with a mirror will be placed in the patient 's midsagittal plane beside the unaffected hand to block his or her view of the affected hand. The patient's unaffected hand does the certain transitive and intransitive tasks and the patient will be instructed to look at the reflection of the unaffected hand in the mirror as if it is the affected hand (the visual input). At the same time the affected hand will be passively moved by the exoskeleton robotic hand which is under the .control of the unaffected hand.
15753917|NCT04826900|Other|Functional task training|After either 45 minutes of RT or RMT, all participants receive 15 minutes of training in functional tasks. The functional tasks included taking up and holding bowl or using eating utensils , bringing a cup for drinking, drying sucks by clips, open ing or closing door , turning on or off the light, cleaning the table or window and so on . The functional tasks training will be bases on the needs and ability of patients.
15753918|NCT04826887|Other|SOLTIVE Thulium Laser|Use of SOLTIVE Thulium laser for HoLEP
15753919|NCT04826887|Other|Standard of Care (Holmium Laser)|Use of Holmium laser for HoLEP
15753920|NCT04826874|Behavioral|Affect labeling|Short behavioral intervention teaching affect labeling
15753921|NCT04826861|Behavioral|SLIM intervention|Core components: 1) goal setting, 2) motivational interviewing, 3) feedback, 4) health technology
15753922|NCT04826848|Diagnostic Test|Lactate|We will evauate the lactate clearance of the patients in 6 hours period. Lactate clearance = [(Initial lactate - 6th hour lactate) / Initial lactate] * 100
15753923|NCT04826835|Behavioral|Prehabilitation intervention|"Participants will:
~Receive four supervised exercise classes (twice per week for two weeks);
~Practice six sessions of home-based exercise (three times per week for two weeks);
~Practice unsupervised respiratory muscle training (daily for two weeks);
~Receive usual care."
15753924|NCT04826835|Behavioral|Health education control|"Participants will:
~Receive four health education talks (twice per week for two weeks)
~Receive usual care."
15753925|NCT04826822|Drug|Spironolactone + Dexamethasone|Low doses of orally administered spironolactone and dexamethasone
15753926|NCT04826822|Drug|Standard-of-care SARS-CoV-2 treatment|Standard-of-care SARS-CoV-2 treatment administered according to the local guidelines
15753927|NCT04826809|Device|N95 mask|Standard 1870 N95 one time use mask
15753928|NCT04826809|Device|Nordell single E-100 layer mask|Nordell mask design using one layer of E-100 fabric plus cotton fabric overlay
15753929|NCT04826809|Device|Nordell double E-100 layer mask|Nordell mask design using two layers of E-100 fabric
15753930|NCT04826796|Behavioral|WhatsApp peer support|Trained peer supporters will provide breastfeeding and emotional support for participants in the WhatsApp group.
15753931|NCT04826783|Device|Lasers|The laser tip was applied as vertical and horizontal scan along the subgingival implant . The procedure was carried out on day zero, seven and 14.
15753932|NCT04826770|Other|anti-SARS-CoV-2 antibody testing|anti-SARS-CoV-2 antibody testing using B cell culture, ELISA, xMAP(R)-based analyses
15753933|NCT04826757|Other|Coordinated care|"Coordinated care between general practioners; physiotherapists and occupational health services.
~Early contact with occupational health service by the general practioner and use of occupational retention tool Active physiotherapy (Individual active, intensive and regular rehabilitation program with 15 sessions of 1 hour, at a rate of 2 or 3 sessions per week)"
15753962|NCT04826432|Other|Saline water|0.9 ml of saline water s.c. twice daily (14 doses) every 12 +/- 2 hours
15753934|NCT04826744|Other|Standard dermatology consultation|"with clinical examination, score filling such as SCORAD and DLQI
~Standard Allergy consultation, with clinical examination, research of atopic or allergic personal and familial history
~Allergy skin testing: patch tests with the Standard European Battery and with some products bring by the patient if necessary, skin prick tests with aero allergens. Two reading of the patch tests will be performed, at H48 and H72.
~ophthalmologic consultation with slit lamp examination and OSDI (self questionnaire)"
15753935|NCT04826731|Other|Incentive Spirometer/Respiratory Exerciser|"A patient is considered acceptable for the Incentive Spirometer Group if the patient can use an incentive spirometer and/or a respiratory exerciser at least four times per day. A pulmonary medicine specialist will confirm the proper usage of the device."
15753936|NCT04826718|Other|Questionaire|"A questionnaire will be administered to all participants to evaluate exposures related to infection at the baseline (enrollement) - Baseline questionnaire. A Follow-up questionnaire to all participants will be done after 3 and 6 months.
~Capillary blood collection, for diagnosis of anti-SARS-CoV-2 Antibodies by rapid test, will be done at the first interview, for all participants (cases and controls).
~Collection of peripheral venous blood, for analysis of the presence and duration of anti-SARS-CoV-2 Antibodies (N and S) will be done at the first interview, and after 6 months for all participants (cases and controls)."
15753937|NCT04826705|Device|Drug-coated Balloon|To observe the effectiveness and safety of the drug-coated balloon in the treatment of lower extremity arteriosclerosis obliterans of the femoral popliteal artery segment.
15753938|NCT04826692|Drug|Metformin|Metformin oral: 425 mg twice daily (initial dose) and 850 twice daily (maximum dose)
15753939|NCT04826692|Drug|Placebo|425 mg twice daily (initial dose) and 850 twice daily (maximum dose)
15753940|NCT04826679|Drug|Camrelizumab, nab-paclitaxel, cisplatin|"Patients receive Camrelizumab IV on day 1, nab-paclitaxel IV on day 1 and cisplatin IV on day 1.
~Treatment repeats every 21 days for up to 3 courses in the absence of disease progression or unacceptable toxicity."
15753941|NCT04826653|Other|Suture removal|Suture removal after coronally advanced flap plus a connective tissue graft
15753942|NCT04826640|Other|Observational|Observational
15753943|NCT04826627|Other|glycemia|capillary glycemia
15753944|NCT04826614|Other|optimized treatment|early adjust dose or change drug
15753945|NCT04826601|Other|essential oils|A total of 40 cancer patients receiving chemotherapy will be recruited as participants in this study. Blood orange and rosewood will be chosen as the essential oils for aromatherapy in this study. Essential oils will be applied to all participants by inhalation for 30 minutes.
15753946|NCT04826588|Drug|Methylprednisolone sodium succinate|Methylprednisolone sodium succinate 10 mg/kg intravenously once daily for 3 days (max 1 g per dose)
15753947|NCT04826588|Biological|Human normal immunoglobulin (IVIg)|Human normal immunoglobulin (IVIg) 2g/kg intravenously as a single dose in line with guidance for dosing and administration in Kawasaki disease
15753948|NCT04826575|Other|High intensity inspiratory and expiratory muscle training|"Inspiratory Muscle Training will be performed using the Threshold inspiratory muscle trainer device (Threshold IMT®, Philips Respironics, Inc., Murrysville, PA, USA).
~Expiratory muscle training (EMT) will be performed using the Threshold positive expiratory pressure device (Threshold PEP®, Philips Respironics, Inc., Murrysville, PA, USA) or Expiratory Muscle Strength Trainer EMST 150TM (Aspire Products), depending on the initial MEP.
~Patients will train 2 times a day, 7 days per week, for 2 weeks."
15753949|NCT04826562|Drug|Dolutegravir/Lamivudine|single tablet antiretroviral
15753950|NCT04826510|Drug|Perospirone hydrochloride tablets|The dosage of perospirone hydrochloride tablets was 16-36 mg / D for 8 weeks.
15753951|NCT04826510|Drug|Lithium carbonate + perospirone hydrochloride|The stable blood lithium concentration was 0.5-1.2 mmol / L, and the dose of perospirone hydrochloride tablets was 16-36 mg / D for 8 weeks.
15753952|NCT04826510|Drug|Lithium Carbonate Pill|Lithium carbonate treatment, stable blood lithium concentration 0.5-1.2 mmol / L, course of 8 weeks.
15753953|NCT04826497|Drug|nicorandil|All patients received antiplatelet agents (aspirin, ticagrelor) and heparin.Diagnostic coronary angiography (CAG) was performed via the radial artery using the Seldinger method.The guidewire was passed into the culprit lesion.If the blood flow of culprit vessel reaches TIMI2-3 after balloon dilatation,6mg nicorandil was then administrated before stent implantation, A minimum 5-min interval occurred between the first and second doses of nicorandil to reduce adverse effects, subsequently , 6mg/h ivgtt. up to 48h after coronary intervention
15753954|NCT04826497|Drug|Placebo（normal saline）|All patients received antiplatelet agents (aspirin, ticagrelor) and heparin.Diagnostic coronary angiography (CAG) was performed via the radial artery using the Seldinger method.The guidewire was passed into the culprit lesion.If the blood flow of culprit vessel reaches TIMI2-3 after balloon dilatation,6mg placebo was then administrated before stent implantation, A minimum 5-min interval occurred between the first and second doses of placebo to reduce adverse effects, subsequently , 6mg/h ivgtt. up to 48h after coronary intervention
15753957|NCT04826471|Device|DermoRelizema ecofoam|DermoRelizema ecofoam, class II a medical device, topical compact mousse, to be applied 2 times per day during the 42 days of study duration
15753960|NCT04826445|Other|Data collection|Imaging collection
15753961|NCT04826432|Drug|Pasireotide 0.9 MG/ML|0.9 mg of pasireotide subcutaneously (s.c.) twice daily (14 doses) every 12 +/- 2 hours
15753963|NCT04826419|Other|ozone therapy|The treatment session of oxygen-ozone was 80 mg/mL ozone (total volume: 60-100 mL) in a special bag using the ozone generator device (Humazon Promedic, German) five times a week for the first week.The treatment session of oxygen-ozone was 40 mg/mL ozone (total volume: 60-100 mL) in a special bag using the ozone generator device (Humazon Promedic, German) twice a week after first week.
15753964|NCT04826406|Drug|Camrelizumab combined Apatinib regimen|Camrelizumab 200mg iv every 2 weeks; Apatinib,250 mg/day.
15753965|NCT04826393|Drug|ASP8374|every 3 weeks by intravenous infusion
15753966|NCT04826393|Drug|cemiplimab|intravenous infusion
15753967|NCT04826393|Drug|89Zr-Df-IAB22M2C|intravenous infusion prior to PET Imaging
15753968|NCT04826380|Procedure|Trapeziectomy|Simple trapeziectomy (without LRTI)
15753969|NCT04826367|Other|Telerehabilitation-based relaxation exercise group (EG)|the participants in this group will perform the relaxation exercises thrice a week, for 6 weeks.
15753972|NCT04826341|Drug|Berzosertib|Berzosertib will be supplied as 20 mg/mL M6620 to be diluted with 5% dextrose in water solution before intravenous infusion.
15753973|NCT04826341|Drug|Sacituzumab Govitecan|Sacituzumab Govitecan will be administered as an intravenous infusion once weekly on Days 1 and 8 of 21-day treatment cycles.
15753974|NCT04826328|Drug|FX301|FX301 is an extended-release formulation of funapide being developed as a single injection peripheral nerve block for the management of acute postsurgical pain
15753975|NCT04826328|Drug|Normal Saline|Single peripheral nerve injection
15753976|NCT04826315|Behavioral|COPE +|Six sixty minute sessions that teaches participants distress and communication coping skills.
15753977|NCT04826302|Other|Myofascial treatment|"40 minutes of myofascial intervention: 10 min in each of the following regions with the patient face up:
~Thoracolumbar fascia and abdomen
~C7-T4 and sternum
~Suboccipital area
~Temporary area"
15753978|NCT04826302|Other|Sham myofascial treatment|"40 minutes of sham myofascial intervention: 10 min in each of the following regions with the patient face up and with the contact of the physiotherapist through a towel and without any intention:
~Thoracolumbar fascia and abdomen
~C7-T4 and sternum
~Suboccipital area
~Temporary area"
15753979|NCT04826289|Radiation|X rays|Radiological assessment of vertical distance between medial and lateral malleolus in normal opulation
15753980|NCT04826276|Other|smoking abstinence|participants will be asked to not smoke for at least 12 hours
15753981|NCT04826276|Other|smoking satiety|participants will be asked to smoke as usual
15753982|NCT04826263|Other|Home Exercise Program|All patients will be instructed to follow a home exercise program for 3 weeks. Patients will be informed about the exercises by giving an exercise sheet describing the exercises and an exercise diary prepared to mark the days they exercise. The home exercise program will include previously recommended exercises such as Achilles tendon and plantar fascia stretching and toe curl exercises. Patients will be instructed to perform these exercises 10 repetitions each and 3 times per day for three weeks.
15753983|NCT04826263|Other|Low-Level Laser Therapy (LLLT)|Patients in the LLLT group will receive gallium-aluminum-arsenide (Ga-Al-As) low-level laser treatment with Chattanooga Vectra Genisys Transport model (Chattanooga Group) with a wavelength of 850 nm and a power of 100 mW. The LLLT treatment will be applied 3 times a week, a total of 10 sessions. A maximum energy density of 5.6 j/cm2 will be reached by delivering a continuously increasing dose of energy to each tender spot for one minute. The LLLT will be performed with patients in the prone position and will be applied to 5 points on the plantar fascia by positioning the laser head perpendicular to the treatment area.
15753984|NCT04826263|Other|Extracorporeal Shockwave Therapy (ESWT)|Patients in the ESWT group will receive treatment with a radial ESWT system (EMS Swiss Dolor Clast), which transforms kinetic energy into a shock wave, which is then applied to the target tissue with pressure varying from 1 to 10 bar and penetrating up to 40 mm. The ESWT treatment will be administered to the patients once a week for three weeks, for a total dose of 2000 mJ/mm2 pulse per application. ESWT will be applied to the patients in prone position with their foot inverted. Ultrasound gel will be applied to the patient's heel The area of tenderness will be palpated and 1000 shock wave impulses were applied to this area, and 1000 pulses will be applied over the plantar fascia.
15753985|NCT04826250|Procedure|Timing of medication|Either morning or nighttime medication
15753986|NCT04826237|Drug|Statin|Oral dose to be taken with methylprednisolone
15753987|NCT04826237|Drug|methylprednisolone|oral dose, standard of care
15753988|NCT04826237|Drug|dexamethasone|Drug for intratympanic administration
15753989|NCT04826237|Drug|Placebo|Capsule the same as for statins but without statin
15753990|NCT04826224|Biological|Concentrated bone marrow aspirate administration after Comprehensive Arthroscopic Management (CAM) surgical procedure.|Bone marrow aspirate concentrate contains a median nucleated cell count of 121,700/uL, and platelets of 384,000/uL. This leads to a cellular dose of approximately 400 million cells.
15753991|NCT04826211|Diagnostic Test|PET/MRI|All included patients will undergo PET/MRI both prior to PST and prior to surgery. In order to analyze results the population will be divided into two groups: women with positive axillary lymph nodes after PST (Group 1) and women with negative axillary lymph nodes after PST (Group 2).
15753992|NCT04826198|Drug|AsiDNA|Unit dose: Vial containing 100 mg of AsiDNA™ (free acid) Regimen: 3 consecutive infusions (D1, D2, D3) followed by a once a week iv infusion on D8 and D15 of a 21 day-treatment cycle at first cycle, then weekly iv infusion in the absence of disease progression or unacceptable toxicity Mode/route: 1 hour intravenous (iv) infusion
15753993|NCT04826198|Drug|Niraparib|"Unit dose: Hard capsule containing 100mg of Niraparib Regimen: The last dose given during the 6 previous months of Niraparib 200 mg/day or 300 mg/day, (or 100 mg/day only if the patient has received this dose since at least 6 months) Daily, 1, 2 or 3 hard capsules at 100mg once daily at approximately the same time each day.
~Mode/route: Per os"
15753994|NCT04826198|Drug|Olaparib|Product name: Olaparib Pharmaceutical form: Tablets containing 100 or 150mg of Olaparib Route of administration: per os Dose Regimen: The last dose given during the 6 previous months of Olaparib 600 mg/day or 500 mg/day, (or 400 mg/day only if the patient has received this dose since at least 6 months) Two times daily (300mg or 250 mg or 200mg) at approximately the same time each day.
15754031|NCT04825990|Drug|Pembrolizumab|200 mg pembrolizumab every 3 weeks plus 300 mg olaparib twice a day (BID) every day starting from Day 1 of Cycle 1.
15753995|NCT04826198|Drug|Rucaparib|Product name: Rucaparib Pharmaceutical form: Tablets containing 200 or 250 or 300mg of Rucaparib Route of administration: per os Dose Regimen: The last dose given during the 6 previous months of Rucaparib 1200 mg/day or 1000 mg/day, or 800mg/day (or 600 mg/day only if the patient has received this dose since at least 6 months) Two times daily (600mg or 500mg or 400mg or 300mg) at approximately the same time each day.
15753996|NCT04826185|Drug|IMB-1018972|Modified release (MR) oral tablet
15753997|NCT04826185|Drug|Placebo|Matching oral tablet
15753998|NCT04826172|Drug|IMB-1018972|Modified release (MR) oral tablet
15753999|NCT04826172|Drug|Placebo|Matching oral tablet
15754000|NCT04826159|Drug|IMB-1018972|Modified release tablet for oral administration
15754001|NCT04826146|Device|Validation of qCON versus BIS|Correlation between qCON and BIS values (main outcome) and qNOX and MOAA/S scale are determined
15754002|NCT04826133|Drug|Calcitriol|Subjects will receive an oral administration of calcitriol (1,25-dihydroxyvitamin D3) 1.5 μg (three capsules of 0.5 μg each) at 9 pm, night before each cocaine session, and at 8 am, morning of each cocaine session. This dose of calcitriol is lower than doses safely administered in other human studies and for a duration of time shorter than doses safely administered in other trials. In addition, this dose has been already tested by our group, subject of a different grant application, and should be effective at enhancing stimulant's induced dopamine release, in comparison to placebo.
15754003|NCT04826133|Other|Placebo|Subjects will receive an oral administration of three capsules of placebo at 9 pm the night before each cocaine session, and at 8 am, morning of each cocaine session.
15754004|NCT04826120|Procedure|PCEA Infusion|Patients of this group Had PCEA during the second stage of labor
15754005|NCT04826120|Procedure|Continuous epidural infusion|Patients of this group Had continuous epidural infusion during the second stage of labor
15754006|NCT04826107|Drug|DP303c treatment|DP303c injection, every 3 weeks.
15754007|NCT04826107|Drug|DP303c treatment（second-line of HER2-positive）|DP303c injection, every 3 weeks.
15754008|NCT04826107|Drug|DP303c treatment （third-line of HER2-positive）|DP303c injection, every 3 weeks.
15754009|NCT04826107|Drug|DP303c treatment（≥second-line of HER2 low expressing）|DP303c injection, every 3 weeks.
15754010|NCT04826107|Drug|DP303c + PD-1/PD-L1 treatment|DP303c injection + PD-1/PD-L1 injection, dose and frequency to be determined.
15754011|NCT04826094|Biological|Env-C Plasmid DNA|2 mg per dose. Administered by intramuscular injection.
15754012|NCT04826094|Biological|HIV Env gp145 C.6980 protein|100 µg per dose. Administered by intramuscular injection.
15754013|NCT04826094|Drug|Rehydragel®|Adjuvant. Aluminum hydroxide fluid gel. 500 µg per dose. Administered by intramuscular injection.
15754014|NCT04826094|Biological|ALF43|Adjuvant. Army Liposome Formulation-43% Cholesterol. 200 µg per dose. Administered by intramuscular injection.
15754015|NCT04826094|Biological|dmLT|Adjuvant. Recombinant double mutant Escherichia coli heat labile toxin. 50 µg per dose. Transcutaneous application (needle-free skin patch). 1 mL diluted dmLT added to gauze pad at site of injection.
15754016|NCT04826094|Drug|Placebo (IM)|0.9% sodium chloride (sterile saline). Administered by intramuscular injection.
15754017|NCT04826094|Drug|Placebo (TCl)|Transcutaneous application (needle-free skin patch). 0.9% sodium chloride (sterile saline) added to gauze pad at site of injection.
15754018|NCT04826081|Other|data collection|data collection
15754019|NCT04826068|Behavioral|Emotional Processing|Processing Emotions of others based on photographs of faces
15754020|NCT04826055|Other|biliary limb as fixed length|n all loop bypass procedures we will don't count the total length of small intestine and make the biliary limb as a fixed from total small intestine length as mentioned in literature
15754021|NCT04826055|Other|biliary limb as a percentage from small intestine length|in all loop bypass procedures we count the total length of small intestine and make the biliary limb as a percentage from total small intestine length rather than fixed length
15754022|NCT04826042|Other|thoracic epidural catheterization|thoracic epidural catheterization
15754023|NCT04826029|Other|Standard strategy|In the standard arm, patients will complete CA 125 (+/- HE4) at 3 months, 6 months, 12 months, 18 months and 24 months (+/- 15 days), complete the HAD and EQ5D self-questionnaires, and be managed according to INCa 2018 recommendations. If clinical symptoms, marker elevation, and/or imaging workup occur, the patient will be referred to the multidisciplinary consultation meeting (MDC) for management according to INCa 2018.
15754024|NCT04826029|Other|Follow-up strategy|In the interventional arm, patients will perform at 3 months, 6 months, 12 months, 18 months and 24 months (+/- 15 days) a CA125 assay (+/- HE4 assay), a thoracoabdominal CT scan after contrast injection and a whole body MRI (T2, DW and T1 sequences after fat saturation before and after gadolinium injection) with a maximum delay of 15 days between the two examinations, and will complete the HAD and EQ5D self-questionnaires. A senior radiologist from each center will perform a prospective reading of each of the images. For any suspicious anomaly identified, the following criteria will be analyzed: Size, location, number, evolution, contrast after injection, MRI signal (T2, Diffusion, Dynamic Enhancement Curve). The RECIST criteria (version 1.1) will be applied.
15754025|NCT04826016|Drug|POL6326|POL6326 (balixafortide): starting dose at 5.5 mg/Kg. Intravenous administration on day 1 and 8 of each 21-day cycle (+/- 1 day) (Phase Ib ARM A and Phase II ARM A ) or on day 1, 8 and 15 of each 28-day cycle (Phase Ib ARM B and Phase 2 ARM B) (+/- 1 day).
15754026|NCT04826016|Drug|Eribulin|Eribulin: 1.23 mg/m2 (equivalent to 1.4 mg/m2 eribulin mesylate). Intravenous administration on day 1 and 8 of each 21-day cycle (+/- 1 day) (Phase Ib ARM A and Phase II ARM A ) or on day 1, 8 and 15 of each 28-day cycle (Phase Ib ARM B and Phase 2 ARM B) (+/- 1 day).
15754027|NCT04826016|Drug|Nab paclitaxel|Nab-paclitaxel: 100 mg/m2. Intravenous administration on day 1 and 8 of each 21-day cycle (+/- 1 day) (Phase Ib ARM A and Phase II ARM A) or on day 1, 8 and 15 of each 28-day cycle (Phase Ib ARM B and Phase 2 ARM B) (+/- 1 day).
15754032|NCT04825977|Other|RISK STRATIFICATION USING AIMS65 SCORE AND RDW|Risk Statification of patients presenting with upper gastrointestinal bleeding to the emergency department using AIMS65 score and Red cell Distribution Width.
15754033|NCT04825951|Other|CS 2000|treating growing Skeletal growing Class III patients
15754034|NCT04825938|Drug|Toripalimab , Carboplatin, Nab-paclitaxel|Patients receive toripalimab IV on day 1, paclitaxel IV on day 1 and carboplatin IV on day 1 . Treatment repeats every 21 days for up to 2 courses in the absence of disease progression or unacceptable toxicity.
15754035|NCT04825925|Device|DEB-BACE(Drug-eluting beads bronchial arterial chemoembolization)|Bronchial arteriography was performed to find tumor-feeding artery. After the catheter had been inserted into the tumor-feeding artery, the Platinum was infused. BAI (Bronchial Arterial Infusion ) chemotherapy was followed by DEB-BACE(Drug-eluting beads bronchial arterial chemoembolization); the CalliSpheres loaded with Vinorelbine were infused into the tumor-feeding arteries until stasis or near-stasis of blood flow in the vessel was observed.
15754036|NCT04825912|Behavioral|Self System Therapy for Older Adults with Advanced Lung Cancer (SST-LC) Resilience|The SST-LC is a brief structured intervention deliverable by video conference. The SST-LC Resilience protocol will incorporate behavioral strategies designed to meet the needs of older adults with lung cancer, including examining individual and shared expectations for lung cancer care, identifying discrepancies between expectations and realistic possibilities, and modifying stress-exacerbating behaviors. The focus will be to test measures of resilience during the intervention period.
15754037|NCT04825886|Device|Zotarolimus-Eluting Stent|Percutaneous coronary intervention using zotarolimus-eluting stent
15754038|NCT04825860|Drug|SEP-363856 50 mg|Subjects will take one tablet of study drug per day at approximately the same time each evening at bedtime. Study drug may be taken orally with or without food.
15754039|NCT04825860|Drug|SEP-363856 75 mg|Subjects will take one tablet of study drug per day at approximately the same time each evening at bedtime. Study drug may be taken orally with or without food.
15754040|NCT04825860|Drug|Placebo|Subjects will take one tablet of study drug per day at approximately the same time each evening at bedtime. Study drug may be taken orally with or without food.
15754041|NCT04825847|Device|BIS monitor|Information provided by the BIS (Medtronic, Canada) monitor will guide the volatile anesthetic administration in the EEG-guided group to maintain a BIS value between 40 and 60, a Suppression Ratio (SR; % of time with suppressed brain electrical activity) at 0% or the closest, a direct EEG display without any suppression time and a spectrogram (DSA or density spectral array) with most of the EEG wave frequency within the Alpha (8-12Hz), Theta (4-8Hz) and Delta (0.5-4Hz) frequencies.
15754042|NCT04825847|Other|Control group|In the standard care group, the age-adjusted Minimum Alveolar Concentration (MAC-age) of sevoflurane will be kept at [0.8-1.2] MAC.
15754043|NCT04825834|Other|Blood Sample Collection|Subjects enrolled in the DELFI-L101 will have blood specimens collected (~40 mL) at enrollment.
15754044|NCT04825821|Procedure|Clinical and ultrasonographic assessment|Routinely post surgical assessment by objective examination and transvaginal ultrasonographic scan
15754045|NCT04825808|Other|usual care|according to recommendations
15754046|NCT04825795|Drug|DPP4-inhibitor|Prescription of DPP4-inhibitor during the period between the two coronary CT scan
15754047|NCT04825795|Drug|No DPP4-inhibitor|No prescription of DPP4-inhibitor during the period between the two coronary CT scan
15754048|NCT04825769|Device|LLLT（Low Level Laser Therapy）|2 times a day, 3 minutes each time, with an interval of more than 4 hours. During the semester: From Monday to Friday, set up an intervention room in the school; For winter and summer vacation: everyday at home
15754049|NCT04825756|Behavioral|Manualized equine assisted therapy|This equine assisted therapy (EAT), which is delivered in a group setting, combines therapeutic horseback riding with cognitive behavioral strategies for anxiety. Each 45 minute session is delivered in a group format with up to four children between 6 and 17 years of age. Each session follows the same structure: (1) weekly review; (2) groom and connect; (3) warm-up period; (4) session activity; (5) cool down; (6) parent/caregiver psychoeducation, during which the instructor facilitates psychoeducation; and (7) homework instruction.
15754050|NCT04825743|Drug|RUC-4|RUC-4 is a novel small molecule inhibitor of the platelet αIIbβ3 receptor specifically designed for first medical contact therapy of ST-elevation myocardial infarction (STEMI).
15754051|NCT04825743|Drug|Placebo|Single-use vials and syringes in randomization kits containing RUC-4 Dose 1 (0.110 mg/kg), RUC-4 Dose 2 (0.130 mg/kg), or placebo will be dispensed in the ambulance
15754052|NCT04825730|Drug|JOINTSTEM|JOINTSTEM is an OA treatment that uses autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissues and is incubated without additional genetic modification or mechanical and chemical modification through differentiation, it is classified as 'autologous cell therapy' and is completely free of immunologic rejection.
15754053|NCT04825717|Other|Nutrition and fluid plans prepared using calorimetry-based measurements.|Nutrition and fluid plans prepared using calorimetry-based measurements.
15754056|NCT04825691|Diagnostic Test|Immunohistochemistry of prostate biopsy|Sections of formalin fixed paraffin embedded tissue blocks will be stained with ERG oncoprotein. Antibody dilution, antigen retrieval methods, and incubation time will all be conducted according to the manufacturer's instructions
15754057|NCT04825678|Drug|Erenumab|Administered as a subcutaneous injection via the SureClick® Autoinjector Pen (AI/Pen).
15754058|NCT04825665|Other|Continuous force|"A buccally directed continuous tipping force of 150 g is applied to the maxillary first premolar by a cantilever spring made of 0.017 x 0.025 beta-titanium-molybdenum alloy inserted in the tube of the upper first molar, bypassing the second premolar and attaching to the upper first premolar. The buccal tipping force will be checked and reactivated to the original level on the 28th day of the 8 week study period."
15754166|NCT04824794|Biological|GEN3014 (HexaBody®-CD38)|GEN3014 is administered by intravenous (IV) infusion
15754167|NCT04824781|Other|Qualitative interview|Participants will be interviewed about their experiences of recovery from paranoia.
15754258|NCT04824092|Drug|Vincristine|Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
15754059|NCT04825665|Other|Intermittent force|"A buccally directed tipping force of 150 g is applied to the maxillary first premolar by a cantilever spring made of 0.017 x 0.025 beta-titanium-molybdenum alloy inserted in the tube of the upper first molar and attaching to the upper first premolar. The buccal tipping force will be removed every 21 days for a 7-day rest period, where a passive wire of the same gauge and material of the cantilever spring (0.017 x 0.025 beta-titanium-molybdenum alloy) will be placed instead to maintain the position of the upper first premolar during the rest period."
15754060|NCT04825652|Drug|177Lu-PSMA-617|Participants will receive 7.4 GBq (200 mCi) +/- 10% 177Lu-PSMA-617 once every 6 weeks for 6 cycles.
15754061|NCT04825652|Drug|PSMA-11|Patients will receive a dose of gallium (68Ga) gozetotide that is 1.8-2.2 MBq/kg of body weight (0.049-0.059 mCi/kg), with a minimum dose of 111 MBq (3mCi) up to a maximum dose of 259 MBq (7 mCi).
15754062|NCT04825639|Other|No intervention|no intervention
15754063|NCT04825626|Biological|HB-adMSCs|Hope Biosciences adipose derived Mesenchymal Stem Cells
15754064|NCT04825613|Biological|HB-adMSCs|Hope Biosciences adipose derived Mesenchymal Stem Cells
15754065|NCT04825600|Diagnostic Test|anti-Toxoplasma gondii IgG and IgM dosage|blood sample performed to check the toxoplasma serological diagnosis
15754066|NCT04825600|Diagnostic Test|cellular test|blood sample performed to evaluate the anti T. gondii cellular immunity and to compare results to the toxoplasma serological diagnosis
15754067|NCT04825587|Procedure|Patients will be randomized into one of two study arms: (1) concomitant ACL and ALL reconstruction or (2) ACL reconstruction alone.|By randomizing patients into one of two study arms: (1) concomitant ACL and ALL reconstruction or (2) ACL reconstruction alone, following statistical analysis, we hope to determine whether concomitant ALL reconstruction in children undergoing and ACL reconstruction will longitudinally result in a lower rate of graft failure than ACL reconstruction alone.
15754068|NCT04825574|Drug|Avapritinib|avapritinib tablet
15754069|NCT04825561|Drug|AD-208|PO, Once daily(QD), 24weeks
15754070|NCT04825561|Drug|AD-2081|PO, Once daily(QD), 24weeks
15754071|NCT04825561|Drug|placebo of AD-208|PO, Once daily(QD), 24weeks
15754072|NCT04825561|Drug|placebo of AD-2081|PO, Once daily(QD), 24weeks
15754073|NCT04825548|Other|No intervention|Examination of patients with previous DVT
15754074|NCT04825535|Behavioral|Standard psychiatry and cognitive behavioral online intervention|The cognitive behavioral online intervention has been assessed in a prior trial. Ritvo, P, Knyahnytska, Y, Pirboglou, M, Wang, W, Tomlinson, G, Zhao, H, Linklater, R, Kirk, M., Katz, J., Harber, L., Daskalakis, ZJ An online mindfulness-based cognitive behavioural therapy intervention for youth diagnosed with major depressive disorders: J Med Internet Res 2021, Mar 17; 23 (3), e24380
15754075|NCT04825535|Behavioral|Standard psychiatry and cognitive behavioural in-person intervention|The effectiveness of standard care office-based group CBT-MM at CAMH is indicated in a past study (n = 119) where depression symptoms reduced (after 16 weeks treatment) by 27% [3,18 ]. The office-based groups follow a carefully conceived structure that centers on the workbook Mind Over Mood (MOM) (Guilford Press) [41]. Key CBT concepts and procedures are conveyed via work sheets that structure personal and group exploration.
15754076|NCT04825522|Drug|Vancomycin|During spinal surgery, participants will receive intrawound vancomycin powder in their wound before closure.
15754077|NCT04825509|Device|Ultrasound|"Diaphragm ultrasound will be done while patient is supine on T-piece during SBT 30 minutes after disconnecting mechanical ventilation. The measurements will be done by placing the transducer in the eighth or ninth intercostal space, between the anterior axillary and the mid-axillary lines.
~Diaphragmatic excursion (DE) will be measured in M-mode using a 1- to 5- Megahertz (MHz) ultrasound curved transducer during maximal breathing. The amplitude of diaphragmatic excursion will be measured as the point of maximal height of the diaphragm to the base line.
~Diaphragmatic thickness (DT) will be measured at both end of maximal inspiration and end of maximal expiration using a high frequency 7-11 MHz ultrasound linear transducer in M-mode. The diaphragm thickness will be measured from the middle of the pleural line to the middle of the peritoneal line."
15754078|NCT04825496|Genetic|ssCART-19 Cells|"Split-Dose of ssCART-19 cells will be infused, and classic 3+3 dose escalation will be applied."
15754079|NCT04825496|Drug|Fludarabine|Fludarabine is used for lymphodepletion.
15754080|NCT04825496|Drug|Cyclophosphamide|Cyclophosphamide is used for lymphodepletion.
15754083|NCT04825470|Procedure|Liver Transplantation|Liver Transplantation
15754084|NCT04825457|Procedure|Anchoring-tip vs. Conventional|"Anchoring-tip: the snare tip was projected from the sheath by 1-2 mm length. Consequently, a small mucosal incision was made at proximal side of lesion. Then the snare was deployed progressively and adjusted around the lesion trying to obtain free margins. At the final step of both conventional and Tip-in EMR, the lesion was resected.
~Conventional: After injection of normal saline solution mix, snaring was tried for polyp resection."
15754085|NCT04825444|Device|Photoacoustic inspection|Use photoacoustic imaging system to image breast blood vessels
15754086|NCT04825431|Drug|TAS-205, [14C]TAS-205|single oral administration under fasted conditions on day 1
15754244|NCT04824131|Drug|Oral cabotegravir (CAB)|30 mg tablets
15754087|NCT04825418|Device|Artic Sun|"Induction phase A. Temperature using by esophageal or bladder thermometer. B. Application of a surface cooling device (Arctic Sun) C. Target temperature: 35 ± 0.5 °C D. Induction should be initiated as soon as possible after surgery (less than 6 hours)
~Maintain phase A. Maintain duration : at least 72 hours and duration can be prolonged according to patient's clinical status B. Use the bedside shivering assessment scale (BSAS) and anti-shivering protocol C. Neuromuscular blocker can be used according to the discretion of the attending physician D. Lung-protective ventilation strategies including low-tidal volume are recommended E. Prophylactic antibiotics can be used to prevent pneumonia during hypothermia
~Rewarming phase A. Rewarming rate: 0.05 - 0.1 ℃/hr (about 20 - 40 hours) to 37 ℃"
15754088|NCT04825405|Procedure|hand motor coordination in a sitting position after use TipStim Glove|The next therapy with the use of Tip Stim took place after a week. The duration of each therapy session was 60 minutes. After the first therapy session and after a week, the parameters of movement coordination and handgrip were examined. The study of motor coordination and grip strength was performed in two different starting positions: sitting (no stabilization) and lying (with stabilization), and with a different position of the examined upper limb. The upper limb was examined in adduction, with the bent elbow joint in the intermediate position of the forearm. In each of the starting positions, first, the range of passive motion in the wrist joint (flexion and extension) and fingers (global flexion and extension) was measured, then the active movement was measured, in the sequence as above. Patients were asked to make movements as quickly and as fully as possible. Measurement of the grip force was performed after testing the ranges of motion and speed/frequency.
15754089|NCT04825392|Drug|HX008|Patients will receive HX008 3mg/kg by intravenous (IV) infusion on Day 1, every 3 weeks (Q3W), till progressed disease or withdrawal.
15754090|NCT04825379|Device|bioactive composite|Cention N
15754091|NCT04825379|Device|posterior composite|G-ænial Posterior
15754092|NCT04825366|Device|Continuous glucose monitoring device|Participants will have to wear their continuous glucose monitoring device throughout the study.
15754093|NCT04825366|Other|Gold method|The Gold method will be used to assess impaired awareness of hypoglycemia
15754094|NCT04825366|Other|Clarke questionnaire|The Clarke questionnaire will be used to assess impaired awarness of hypoglycemia
15754095|NCT04825366|Other|Edinburgh Hypoglycemia Symptom Scale|The Edinburgh Hypoglycemia Symptom Scale will be used to assess symptoms of hypoglycemia
15754096|NCT04825366|Other|BAPAD questionnaire|The BArriers to Physical Activity in type 1 Diabetes (BAPAD) questionnaire will be used to assess barriers of physical activity
15754097|NCT04825366|Other|Hypoglycemia Fear Survey II|The Hypoglycemia Fear Survey II will be used to assess fear of hypoglycemia
15754098|NCT04825366|Other|Physical activity questionnaire|The International Physical Activity Questionnaire will be used to assess physical activity practice
15754099|NCT04825366|Other|Well-being|The WHO-5 well-being index will be used to assess well-being.
15754100|NCT04825366|Other|Treatment satisfaction|The Diabetes Treatment Satisfaction Questionnaire will be used to assess treatment satisfaction.
15754101|NCT04825366|Other|Hypoglycemia diary|Participants will be asked to record in a diary treatments for hypoglycemic events
15754102|NCT04825366|Device|Piezo RxD|Participants will be asked to wear a pedometer throughout the study
15754103|NCT04825366|Device|Heart rate monitor|During training sessions, participants will be asked to wear a heart rate monitor
15754104|NCT04825366|Other|Exercise diary|Before each training session, participants will be asked to note in a diary their glucose levels, if they have taken a snack or not and if insulin was administered. After each training session, participants will be asked to note that same information. In addition, they will be asked to note their bedtime blood glucose, if they have taken a bedtime snack and if adjustment to insulin doses was made.
15754105|NCT04825353|Procedure|Endoscopic compbined guided PCNL|patient undergo stone removal by ECIRS
15754106|NCT04825353|Procedure|Standard PCNL|patient undergo SPCNL
15754107|NCT04825340|Biological|Nasal Spray Lyophilized Live Attenuated Influenza Vaccine|0.2 ml/vial, 0.2ml/dose/per person
15754108|NCT04825314|Device|Urethral catheter|All Patients will have urethral catheterization with either Noble Metal Alloy coated catheter or Silicon Foley catheter.
15754109|NCT04825288|Biological|XB2001 or Placebo|XB2001 has an IgG4, heavy chain and a kappa light chain. The heavy chains are joined at their hinge regions through two disulfide linkages and each heavy chain is joined to one light chain through one disulfide linkage between their CH1 and CL domains respectively. The heavy chain CH2 domains are glycosylated primarily with the oligosaccharide structure shown in Figure 2.1, as determined by cleaved N-glycan analysis performed by ProteomeLab PA800 Plus. The glycosylated residue (Asn-295 as numbered from the N-terminus of XB2001) is in the same highly conserved N-linked glycosylation site as found in endogenous IgG4 (Asn-297 according to the generic numbering system). Similarly, the primary glycan, commonly referred to as G0F, is the same as that found in about 22% of endogenous human IgG molecules . The main isoform has a pI of about 6.47 and comprises over 60% of the total isoform population, as determined by capillary isoelectric focusing.
15754110|NCT04825275|Drug|Posaconazole Pill|300 mg (three 100 mg tablets) orally
15754111|NCT04825262|Drug|Tacrolimus|Starting dose based on CYP3A5 genotype
15754112|NCT04825249|Procedure|traditional suture bridge technique|(A) Limbs of the sutures from the medial anchor were passed through torn tendon (B) the suture limbs were tied in a horizontal mattress suture pattern (C) the lateral row pressed the free tails of the knotted line on the greater tubercle of the humerus (D) the effect after completion of the TSB technique
15754113|NCT04825249|Procedure|modified suture bridge technique|(A) Limbs of the sutures from the medial anchor and 2 tendon sutures were passed through the same position of torn tendon (B) the lateral row pressed free tails of the two tendon lines on the greater tubercle of the humerus (C) after examination of sufficient tension and stable fixation, sutures of medial row was knotted (D) the effect after completion of the MSB technique
15754245|NCT04824131|Drug|CAB LA|Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
15754246|NCT04824131|Drug|Oral tenofovir disoproxil fumarate/emtricitabine (TDF/FTC)|300 mg/200 mg fixed-dose combination tablets
15754247|NCT04824118|Diagnostic Test|Thromboelastometry|Point of Care Test for clotting parameters (ClotPro device)
15754259|NCT04824092|Drug|Prednisone|Prednisone PO will be administered as per the schedule specified in the respective arm.
15754114|NCT04825236|Other|MyVoice:CF|"Participants will be given access to MyVoice:CF, a web-based decision aid (DA). This tool includes information about fertility, genetics, parenting, pregnancy, and breastfeeding within the context of cystic fibrosis (CF). The tool includes interactive elements designed to give users the ability to assess and reflect on their own reproductive goals and experiences and promote self-efficacy to engage in shared decision-making with their CF and women's health providers.
~Upon completion of use of the decision aid, a summary sheet is generated based on the user's interaction with the tool. This summary is supplied to the provider prior to the next appointment."
15754115|NCT04825223|Drug|Multicomponent Meningococcal B Vaccine|Pharmaceutical form:Liquid suspension for injection in a single vial Four liquid suspensions and one diluent (only for Stage 1) Route of administration: Intramuscular
15754116|NCT04825223|Drug|Meningococcal Group B Vaccine MenB|Pharmaceutical form:Liquid suspension for injection in a pre-filled syringe Route of administration: Intramuscular
15754117|NCT04825223|Drug|Meningococcal Group B Vaccine (recombinant deoxyribonucleic acid [rDNA], component, adsorbed)|Pharmaceutical form:Liquid suspension for injection in a pre-filled syringe Route of administration: Intramuscular
15754118|NCT04825223|Drug|Placebo|Pharmaceutical form:Liquid solution for injection in a vial Route of administration: Intramuscular
15754119|NCT04825223|Drug|Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine|Pharmaceutical form:Liquid solution for injection in a vial Route of administration: Intramuscular
15754120|NCT04825210|Behavioral|Integrated Behavioral Health - Prevention|IBH-P consists of 15-30 minute visits with mothers as part of the 1, 2, 4, and 6 month well-child visits. The intervention is delivered by doctoral level pediatric psychologists that are an integrated member of the primary care team.
15754121|NCT04825210|Behavioral|Bright Futures: Guidelines for Health Supervision of Infants, Children, and Adolescents, 4th Edition|Bright Futures curriculum will be delivered by the pediatrician as part of the 1, 2, 4 and 6 month well-child visits.
15754122|NCT04825197|Drug|Poractant Alfa Intratracheal Suspension [Curosurf]|up to 4 doses (100 mg Kg) of Poractant alfa every 12 hours; each dose preceded by a recruitment manoeuvre in HFOV.
15754123|NCT04825184|Behavioral|Body image chatbot|See arm/group description.
15754124|NCT04825171|Drug|Bryophyllum 50 % Chewing Tablets|Each 350 mg tablet corresponds to 170 mg of leave press juice from Bryophyllum pinnatum, dried down to 17 mg by mixing with lactose; 100 mg dried BP matter in 1 g.
15754125|NCT04825145|Other|Pregnancy|Pregnancies complicated by preeclampsia
15754126|NCT04825132|Other|Geriatric assessment tools|Multidimensional Prognostic Index (Living status, medications, ADL, IADL, MMSE mental evaluation, ESS pressure sores, chronic disease, nutritional assessment)
15754127|NCT04825119|Drug|Nusinersen|Patients with SMA who will be treated with nusinersen will be included.
15754128|NCT04825106|Other|Diagnostic context|A life-threatening situation occurs in 3 different contexts
15754129|NCT04825093|Dietary Supplement|Vitamin D supplementation in pregnant women|Intervention group will be administered 2,000 UI of vitamin D and a control group will be administered 400 UI of vitamin D. Participants will take the supplementation from the enrollment to delivery.
15754130|NCT04825080|Diagnostic Test|duplex ultrasound and computed tomography angiography|Identification of carotid artery stenosis > 60% NASCET criteria
15754131|NCT04825067|Device|Respiratory Sensor measurements|The participant will receive 2 Respiratory Sensors and 1 gateway with wireless compatibility and a welcome packet with instructions for use, a reminder description of the study purpose and procedures, and research staff contact information. Research staff will contact participants to ensure appropriate setup of the Respiratory Sensor and training on proper use. Research staff will ask the subject to place the Respiratory Sensor on the top left-side of the chest. The Respiratory Sensor continuously collects and monitors respiratory data. The participant will be instructed to change each Respiratory Sensor after 24-48 hours. Subjects will be asked to charge each Respiratory Sensor once it is removed. Subjects will exit the study upon completion of the 90-day follow-up.
15754132|NCT04825054|Device|Mechanical ventilation with NAVA mode|"To compare the hemodynamic and pulmonary effect in patients after surgical repair with right ventricular hypertrophic ventilated with PCV, PSV and NAVA by a crossover study.
~Each patient will undergo three 60-min trials during the study period in randomized order. The cardiac output and volume status will be evaluated by a transpulmonary thermodilution device through a pulse contour cardiac output (PiCCO) catheter at the last 10min of each trial. At the mean while an arterial blood gas and echocardiography will perform."
15754133|NCT04825054|Device|Mechanical ventilation with PCV mode|"To compare the hemodynamic and pulmonary effect in patients after surgical repair with right ventricular hypertrophic ventilated with PCV, PSV and NAVA by a crossover study.
~Each patient will undergo three 60-min trials during the study period in randomized order. The cardiac output and volume status will be evaluated by a transpulmonary thermodilution device through a pulse contour cardiac output (PiCCO) catheter at the last 10min of each trial. At the mean while an arterial blood gas and echocardiography will perform."
15754134|NCT04825054|Device|Mechanical ventilation with PSV mode|"To compare the hemodynamic and pulmonary effect in patients after surgical repair with right ventricular hypertrophic ventilated with PCV, PSV and NAVA by a crossover study.
~Each patient will undergo three 60-min trials during the study period in randomized order. The cardiac output and volume status will be evaluated by a transpulmonary thermodilution device through a pulse contour cardiac output (PiCCO) catheter at the last 10min of each trial. At the mean while an arterial blood gas and echocardiography will perform."
15754135|NCT04825041|Diagnostic Test|Patency test|Successive flow test, bubble flow test and peristalsis test
15754136|NCT04825028|Device|Angiography-drived Index of Microcirculatory Resistance|"From coronary angiographic images, angiography-derived IMR will be calculated based on mathematical calculation.
~Angiography-derived IMR = (hyperemic Pa x angiography-derived FFR) x (vessel length / {K x V diastole}).
~Hyperemic Pa will be estimated from resting Pa according to prespecified equation."
15754137|NCT04825015|Device|VEnaRt Cardiac Output|Every patient is monitored during liver transplantation with VEnaRt Cardiac Output versus Swan-Ganz Catheter
15754138|NCT04825002|Diagnostic Test|Urinary multimarker sensor|We will develop a urinary multimarker sensor, able to measure trace amounts of biomarkers from naturally voided urine.
15754248|NCT04824118|Diagnostic Test|Clotting Studies|"Standard laboratory tests for clotting:
~International normalised ratio (INR)
~Prothrombin time (PT)
~adjusted partial thromboplastin time (aPTT)
~fibrinogen"
15754139|NCT04824989|Behavioral|Sleep Health in Preschoolers (SHIP)|SHIP is an 8 session home visiting intervention to reduce child sleep problems using a framework that draws from motivational interviewing and social cognitive theory, and effectively improves sleep timing, duration, and quality. Following ecological assessment of child sleep and sleep routines, feedback is provided on family strengths and challenges in the child sleep domain, with motivational interviewing to increase parent knowledge of sleep, correct misperceptions, and raise outcomes expectations. The remaining sessions are targeted modules that give tailored feedback and education, and coach the parent in setting manageable goals, identifying action steps, anticipating barriers, and supporting positive behaviors. Targets: bedtime scheduling, consistency, and routines; media use, independent sleep onset, nightmares and fears, night wakings, and early waking; sleep location, nap issues, engaging other caregivers.
15754140|NCT04824989|Behavioral|Family Check-Up (FCU)|FCU is an 8 session home visiting intervention to reduce behavior problems for children through improved parenting. Over 30 years of research establishes its efficacy in reducing behavioral and emotional problems, including in low income toddlers. Following ecological assessment of behavior management and child behavior, family receives feedback on family strengths and challenges within the behavioral domain via a motivational interviewing approach. The remaining sessions are targeted modules drawn from the Everyday Parenting curriculum, individualized based on parent goals and identified challenge areas. Each session begins by establishing a collaborative skill set, involves teaching the rationale for a skill, teaching and modeling effective use of the skill, and then role play and experiential practice to coach the parent to success. Targets can include Positive Behavior Support, Limit Setting and Monitoring, Family Routines, Communication, and Problem Solving.
15754141|NCT04824989|Behavioral|Oral Health, Child Safety, and Environmental Health Intervention (Active Control)|This intervention serves as an active control condition to ensure that observed effects are due to the intervention content, rather than to study processes, staff attention, or general support and problem solving. The intervention is designed to be comparable to SHIP and FCU in intensity, personal contact, session structure and approach, but focused on Oral Health, Child Safety, and Environmental Health, domains which should not immediately affect study outcomes.
15754142|NCT04824976|Dietary Supplement|Blueberry|freeze-dried Northern highbush blueberry powder twice daily 15g = 60kcal
15754143|NCT04824976|Dietary Supplement|Placebo|matched powder maltodextrin twice daily = 60kcal
15754144|NCT04824950|Other|Circulating tumor DNA monitoring|Monitoring of circulating tumor DNA after 2 and 4 cycles of chemotherapy
15754145|NCT04824937|Drug|Telaglenastat|Capsule, taken by mouth
15754146|NCT04824937|Drug|Talazoparib|Capsule, taken by mouth
15754147|NCT04824924|Drug|The combination of HHT, venetoclax, AZA, G-CSF|HVAG regimen in a 28-day cycle HHT: d1-d7 1mg/m2; VEN: d1 100mg, d2 200mg, d3-d28 400mg; AZA: d1-d7 75mg/m2; G-CSF: d1-d7 300mg
15754148|NCT04824911|Drug|Clopidogrel|300mg loading and 75mg/day from day 2
15754149|NCT04824911|Drug|Aspirin|Aspirin(100-300mg/day)
15754150|NCT04824911|Drug|Atorvastatin|Atorvastatin 40-80mg/day
15754151|NCT04824911|Drug|Rosuvastatin|Rosuvastatin 20 mg/day.
15754152|NCT04824898|Drug|Simvastatin|Statins are first known as drugs that decrease the cholesterol level by inhibiting hydroxy-methyl-glutaryl co-enzyme-A reductase as they improve the lipid profile and help in the treatment of many cardiac diseases and has a role in osteoblasts diffrentiation
15754153|NCT04824898|Other|injectable plasma rich fibrin|I- PRF is obtained by taking a blood sample from patients and then is centrifuged for three minutes at 3300 rpm, the I-PRF first will be in the form of liquid and then coagulate after few minutes from the injection
15754154|NCT04824885|Device|Chlorhydric acid based acid concentrate for bicarbonate hemodialysis (medical device)|usual dialysate (A + D) for 6 months and then switch to A-D dialysate for the next 6 months
15754155|NCT04824872|Drug|Dasiglucagon|dasiglucagon SC, low dose
15754156|NCT04824872|Drug|Dasiglucagon|dasiglucagon SC, high dose
15754157|NCT04824872|Drug|Placebo|placebo for dasiglucagon
15754158|NCT04824859|Behavioral|Behavioral|eGAP that allows patients to complete validated questionnaires, and these questionnaires will be summarized and recommendations provided to the treating team
15754159|NCT04824846|Behavioral|Integrated back pain module (IBPM)|All Ambulance drivers will be screening with the Proforma to determine their low back pain symptoms. Those workers who are diagnosed with mechanical back pain during the 12 months fulfill a self-report quality of life questionnaire (SF-36). Then Integrated back pain module (IBPM) will be delivered to them after the introduction course conducted for 1 day and then the intervention will last for 6 months. Research staff will explain how to operate and use the module. Subjects must comply with all the care and prevention guidelines of the research module so that it achieves the expected results. They also need to complete the checklist provided in the Edmodo software via their respective smartphones.
15754160|NCT04824846|Other|Health Educational Pamphlet.|In Health Educational Pamphlet (HEP) sessions, Participants will be taught the importance of movement and activity, pain management techniques, and methods for developing spinal posture awareness during activities of daily living (e.g., lifting, pushing, pulling, sitting, getting out of bed, and using a backpack).
15754161|NCT04824833|Procedure|Serratus anterior plane block|local anesthetic application between serratus anterior muscle and 5th rib
15754162|NCT04824820|Behavioral|Vibrator|Clitoral stimulation
15754163|NCT04824807|Other|Yoga|"The yoga classes included a progression of low-impact, modified poses, stretching and isometric exercises focused on the shoulders, arms, and chest, and meditation. Breathing and poses to drain the lymphatic system were incorporated throughout the yoga practice to assist with lymphatic flow.
~Exercises: sitting down badrasana, ardha navasana, dhanurasan, setu bandhasana, Urdhva Dhanurasana, Urdhvamukha Svanasana, Virabhadrasana, Warrior Virasana, Supta Virasana, Surya Namaskar, Mayurasana, Padmasana, Bharadvajasana."
15754164|NCT04824807|Other|Clinical Pilates|"before starting the clinical Pilates exercise program, the patients were trained on Pilates exercises and postures. During training, the patients were taught how to create lumbopelvic stability (core stabilization), which is the basis for Pilates exercises, and spinal stabilization and appropriate posture techniques.
~Exercises: cork screw, toy soldier, kleopatra, the saw,breast stroke preparation, swimming, diamond press - arm openings, scapula isolations, open book, scissors, shoulder bridge."
15754165|NCT04824807|Other|An educational booklet|Only educational booklets will be given to the control group
15754249|NCT04824118|Diagnostic Test|Full Blood Count|For platelet count
15754168|NCT04824768|Device|CRet|"CRet is a non-invasive diathermy technique that provides high frequency energy generating a thermal effect on soft tissues. Functional massage (FM) is a non-invasive manual therapy technique that combines rhythmical passive joint mobilization with compression of the muscular belly with the muscle-tendon insertions to be treated.
~In prone position, subjects will get a 7 min preparation massage with CRet on resistive mode (80-100W), on the lumbar area, followed by a 5 min preparation massage with CRet on resistive mode (100-120 W) on the hamstrings. Then a 5 min F.M with passive ankle dorsiflexion and CRet on resistive mode (110-120 W) will be performed on the gastrocnemius medialis and lateralis, followed by a 4 min FM with CRet on capacitive mode (180-250VA) on the mentioned area.
~In supine position, a 5 min FM with passive knee flexion and CRet on resistive mode 8.
~A physiotherapist will monitor the temperature of the patient's treated area every 2 minutes"
15754169|NCT04824768|Device|Sham CRet|"In prone position, subjects will get a 7 min preparation massage with CRet on resistive mode (0 W), on the lumbar area, followed by a 5 min preparation massage with CRet on resistive mode (0 W) on the hamstrings. Then a 5 min FM with passive ankle dorsiflexion and CRet on resistive mode (0 W) will be performed on the gastrocnemius medialis and lateralis, followed by a 4 min FM with CRet on capacitive mode (0 VA) on the mentioned area.
~In supine position, a 5 min FM with passive knee flexion and CRet on resistive mode 0.
~A physiotherapist will monitor the temperature of the patient's treated area every 2 minutes"
15754170|NCT04824755|Procedure|Yune Zhao|Yune Zhao did congenital cataract surgeries
15754171|NCT04824742|Procedure|Neoadjuvant PDT + radical surgery|Patients with cholangiocarcinoma will undergo radical surgery after photodynamic therapy
15754172|NCT04824742|Procedure|Radical surgery|Patients with cholangiocarcinoma will only receive radical surgery
15754175|NCT04824716|Procedure|Postconditioning|The protocol of primary PCI followed by stenting is executed according to the descriptions according to the majority of relevant scientific literature on postconditioning studies and in accordance with the most recent guidelines. In the post conditioned group, after recanalization, the artery is occluded by inflation of stent balloon (4 times for 1-1 minute) followed by 1-1-minute reperfusion, repeatedly. Eight minutes after the start of examination, angiography is made in order to determine blood flow. Intervention is finished by the operator and another angiographic image is made (identical to initial standard projection).
15754176|NCT04824716|Device|Percutaneous coronary intervention|Percutaneous coronary intervention as per European Society of Cardiology guidelines.
15754177|NCT04824703|Drug|Oxygen|"Decreasing fraction of inspired oxygen and its effect on mortality and myocardial function
~administered by invasive mechanical ventilation with fraction of inspired oxygen between 0.21 and 1"
15754178|NCT04824690|Device|Virtual reality|Immersive virtual reality tour of the operating theatre before surgery and distraction methods both using VR headset
15754179|NCT04824677|Other|Hospital treatment of COVID disease|Hospital treatment of COVID disease
15754180|NCT04824664|Other|survey|survey among surgeon
15754181|NCT04824651|Biological|COVID-19 vaccine|Vaccination done as part of France's COVID-19 Vaccination Campaign
15754182|NCT04824638|Biological|two doses of BNT162b2 vaccine|Administration of BNT162 b2 vaccine (30µg in 0.3mL) at D1 and D29, intramuscularly (participants without antecedent of SARS-CoV-2 infection)
15754183|NCT04824638|Biological|one dose of BNT162b2 vaccine|Administration of BNT162 b2 vaccine (30µg in 0.3mL) at D1, intramuscularly (participants with antecedent of SARS-CoV-2 infection)
15754184|NCT04824612|Device|Photobiomodulation with blue led|Preoperative: every two weeks for 30 days. Postoperative: Immediately after surgery, weekly for 4 weeks, every two weeks for another 4 weeks, and one session in 3rd month. blue LED (470 nm, 0,4W, 24J per point on 10 linear points, total 240J).
15754185|NCT04824612|Drug|Triamcinolone Hexacetonide|intralesional injection of 20 mg/ml. two injections in the preoperative period with a two-week interval between injections and a monthly injection for three months in the postoperative period. The injections will be intralesional and will not surpass the dermis. The drug will be diluted with the same quantity of 2% lidocaine. The scar will be divided into equal parts of 1 cm² and the drug will be distributed equally, respecting the total dose per session of 20 mg for the face and 40 mg for other topographies.
15754186|NCT04824612|Device|Sham LED|A blue LED without power and biologic effect.
15754187|NCT04824599|Procedure|PECS II|Pectoral nerves block (PECS II) is performed with the help of ultrasound. Two injection are performed in two fascial planes. One between pectoralis major muscle and serratus anterior muscle. Second one between pectoralis major and minor muscles.
15754188|NCT04824599|Procedure|Local anesthetic infiltration|Ropivacaine is administered by surgeon prior to scrubbing and following the removal of the tumor.
15754189|NCT04824599|Procedure|Subcutaneus local anesthetic infiltration|Ropivacaine is administered by the surgeon at the end of surgery
15754190|NCT04824599|Drug|Ropivacaine|Local anesthetic ropivacaine is administered in both study arms according to the study protocol
15754191|NCT04824599|Device|bk medical Flex Focus 500 Ultrasound Machine|Ultrasound with linear probe is performed. Using in-plane technique a correct placement of the injection needle is secured.
15754192|NCT04824586|Drug|Fast-acting human insulin|Both patients in the infusion or bolus group received their dose of insulin. The protocol of the insulin regimen and its related details were carried out according to the standard recommendations in a hospital where the trial done.
15754193|NCT04824573|Device|Inspiratory Muscle Training|Inspiratory Muscle Training (IMT) was performed with Powerbreathe Classic-Light Resistance device. To determine the intensity of the training, MIP values were measured with the help of the respiratory pressure meter-RP Check (MD Diagnostics Ltd. RP Check MIP & MEP) device before each training. The pressure corresponding to 50 percent of the MIP value in the Powerbreathe device was determined as training workload. It was applied two days a week for four weeks, with five-set and five repetitions, for 20 minutes with 30 seconds rest in between. This inspiratory muscle training program has previously been used by several studies to improve respiratory muscle strength.
15754250|NCT04824118|Diagnostic Test|Quantitative hCG|Serum human chorionic gonadotrophin
15754251|NCT04824118|Diagnostic Test|Pregnancy Test|Point of care urinary pregnancy test
15754194|NCT04824573|Other|Manual Therapy|"In the manual diaphragm release technique; While the participant was breathing in, the physiotherapist raised his hand slowly to accompany the rising movement of the ribs and deepened the contact during exhalation. The maneuver was performed in two sets of 10 deep breaths.
~In thoracic mobilization application; The physiotherapist, standing behind the participant, wrapped the crossed arms from his right upper arm with his left hand and performed stretching, extension, lateral flexion, and thoracic rotation with his right hand.
~In HVLA thoracic manipulation; the physiotherapist, with the support hand on the participant's elbows, applied HVLA thrust in the posterior-anterior and inferior-superior directions with the help of his body while the manipulating hand was on the transverse processes.
~For cervical joint mobilization; the physiotherapist was applied using the right hand in flexion, extension, right-left rotation, and lateral flexion directions."
15754195|NCT04824560|Behavioral|Blood pressure education|One page teaching protocol performed by pharmacy students; phone follow-up
15754197|NCT04824534|Other|Motion analysis|Motion analysis is performed in the Motionlab using Vicon systems. Surgery (in case of SI patients) is performed with iFuse implant system for sacroiliac joint fusion
15754198|NCT04824521|Behavioral|Mindfulness-Oriented Recovery Enhancement|MORE is a mindfulness-based intervention.
15754199|NCT04824508|Behavioral|position|teamleaders are instructed to allocated position
15754200|NCT04824495|Diagnostic Test|Blood sample|Blood samples at different timepoints during SARS-CoV2 infection
15754201|NCT04824482|Other|Robot-assisted gait training (RGT)|Locomotor training guided by the robotic device (Lokomat Hocoma) according to a pre-programmed gait pattern with the help of robot-driven exoskeleton orthoses. The process of gait training is automated and controlled by a computer under supervision of a physiotherapist.
15754202|NCT04824482|Other|Therapist-assisted gait training (TGT)|Locomotor training via a repetitive execution of walking movements manually guided by a physiotherapist during treadmill gait training.
15754203|NCT04824469|Other|intervention group|web based training: By establishing a website, training on drug use, symptom management and quality of life will be provided.
15754204|NCT04824456|Procedure|bilateral sagittal split osteotomy using separators.|The final split is completed with a thin osteotomes, splitting the entire ascending ramus from the anterior to the posterior border of the ramus.
15754205|NCT04824443|Other|Aerobic Exercise Therapy|Aerobic Exercise Therapy/AT will consist of 30 weeks of treadmill walking sessions. AT will consist of supervised, individualized walking delivered up to 6 times weekly (over a 7-day period) to achieve a cumulative total duration ranging from 90 mins/wk up to 375 mins/wk following a non-linear dosing schedule. The planned dose and scheduling of AT will be continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period (i.e., non-linear periodized schedule).
15754206|NCT04824417|Drug|Itraconazole 200 mg|Control
15754207|NCT04824417|Drug|Voriconazole 200mg|Comparator
15754208|NCT04824404|Behavioral|CBT4CBT-Buprenorphine + Recovery Coach|This condition will consist of the CBT4CBT-Buprenorphine intervention alongside weekly coaching sessions from a recovery professionalCBT4CBT-Buprenorphine is an 8-session (module) system for teaching a wide range of CBT skills (understanding and changing patterns of substance use; coping with craving; refusing offers of drugs and alcohol; problem-solving skills; identifying and changing thoughts about drugs and alcohol; and improving decision-making skills)
15754209|NCT04824391|Biological|ERUCOV-VAC 3 µg/0.5 ml Vaccine|Two IM applications on Days 1 and 28
15754210|NCT04824391|Biological|ERUCOV-VAC 6 µg/0.5 ml Vaccine|Two IM applications on Days 1 and 28
15754211|NCT04824391|Other|Placebo|Two IM applications on Days 1 and 28
15754212|NCT04824378|Other|No Intervention.|No Intervention.Only learn ICG image features of different label groups
15754213|NCT04824365|Drug|Sodium Pyruvate|Subjects will use a sodium pyruvate nasal spray 3x daily for 14 days.
15754214|NCT04824365|Other|Saline|Subjects will use a saline nasal spray 3x daily for 14 days.
15754215|NCT04824352|Drug|apatinib|Apatinib: 500 mg QD po (BSA ≥ 1.0) or 250 mg QD po (BSA < 1.0); IE: ifosfamide 1.8 g/m2/d d1-3; etoposide 100 mg/m2/d d1-3 Q2w
15754216|NCT04824339|Behavioral|Immediate Intervention Group|This study is a partial cross over study. The intervention is 8 weeks in duration. Participants will be randomized to immediate exercise or delayed exercise, and the delayed exercise group will cross over to the intervention after 8 weeks.
15754217|NCT04824339|Behavioral|Delayed Intervention Group|This study is a partial cross over study. The intervention is 8 weeks in duration. Participants will be randomized to immediate exercise or delayed exercise, and the delayed exercise group will cross over to the intervention after 8 weeks.
15754218|NCT04824326|Behavioral|PSAI-CA|"The intervention is based on the principles of the teaching of the ancient Greek philosopher Pythagoras. These principals set a basic framework for behavior on the basis of experiential learning and weekly evaluation of the implementation of 12 virtues. The technique is practiced twice a day(before night sleep and in the morning before getting up from bed) and evolves into five successive steps;1)reading of the 12 virtues and diaphragmatic breathing, 2)recall every event og the day,3)third person visualization and self-observation, 4)self-dialogue What have I done wrong?, What have I done right?, What have I omitted that I ought to have done? Endorsement or disapproval of actions according to the 12 virtues and the instructions for a healthy lifestyle, 5) next morning brief revision of the previous night's conclusions and setting of goals for the upcoming day."
15754219|NCT04824313|Diagnostic Test|Chest CT|Chest CT without intravenous contrast material
15754220|NCT04824313|Diagnostic Test|Chest CTA|Chest CT with intravenous contrast material
15754252|NCT04824105|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|A repetitive Transcranial Magnetic Stimulation (rTMS) MagVenture MagPro TMS System will be used to deliver intermittent theta burst to ventromedial prefrontal cortex, and continuous theta burst to pre-supplementary motor area.
15754253|NCT04824092|Drug|Tafasitamab|Tafasitamab IV infusion will be administered as per the schedule specified in the respective arm.
15754254|NCT04824092|Drug|Lenalidomide|Lenalidomide PO will be administered as per the schedule specified in the respective arm.
15754255|NCT04824092|Drug|Rituximab|Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
15754256|NCT04824092|Drug|Cyclophosphamide|Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
15754221|NCT04824300|Procedure|erector spinae block|Erector spina plane block (ESP) is a technique used in many surgeries for anesthesia and analgesia. It is frequently preferred by anesthesiologists for postoperative analgesia recently because it is easy to apply and no complications are reported in the literature. Erector spina muscle, with arms of iliocostalis, longissimus and spinalis, is located parallel to the spine, from the back of the skull to the pelvis. The injected local anesthetic is distributed in many levels in the cranio-caudal direction and blocks the intercostal spinal nerves, causing sensory block. Providing the necessary perioperative analgesia due to the complex innervation of the breast tissue is a big controversy among anesthesiologists. Multimodal analgesia methods with various regional blocks are more preferred. Erector Spina Plane block is also preferred as another method since it provides both perioperative and postoperative analgesia
15754222|NCT04824287|Other|pelvic floor muscle exercise|pelvic floor muscle exercises training from the researcher using the Roy Adaptation Model in addition to routine discharge training Face-to-face training was given to the individuals in the experimental group on the day before the operation, on the second and third postoperative days, and on the day of discharge. The training continued with phone calls at the first, second and third weeks and the first, second, third, and sixth months after the surgery Patients practiced exercises 6 month after surgery
15754223|NCT04824274|Drug|fentanyl|Fentanyl 10 mcg will be injected intrathecally during spinal anesthesia.
15754224|NCT04824274|Drug|morphine|Morphine 75 mcg will be injected intrathecally during spinal anesthesia.
15754225|NCT04824274|Procedure|Transversus abdominis plane block|Ultrasound-guided bilateral transversus abdominis plane block will be done. 0.375% ropivacaine 15 ml per side will be injected.
15754226|NCT04824274|Procedure|Sham block|Ultrasound-guided bilateral transversus abdominis plane sham block will be done. Normal saline 15 ml per side will be injected.
15754227|NCT04824261|Drug|Clotrimazol solution 1%|50 otomycosis randomized patients will receive Clotrimazol solution 1% The treatment will be locally applied for at least 2 weeks. All the patients will be followed up after the 1st week, 2nd week and after 1 month.
15754228|NCT04824261|Drug|4%boric acid in distilled water|50 otomycosis randomized patients will receive 4%boric acid in distilled water The treatment will be locally applied for at least 2 weeks. All the patients will be followed up after the 1st week, 2nd week and after 1 month.
15754229|NCT04824248|Behavioral|Pain Neuroscience Education|Increase pain coping skills and educating the patients that pain is in the brain, and that hypersensitivity of the central nervous system rather than local tissue damage contributes to their symptoms.
15754230|NCT04824248|Behavioral|Cognition-targeted exercise therapy|Daily (physical) activity and exercise therapy. To confront the patient with movements and activities that are feared, avoided and/or painful using a gradual and cognition-targeted approach.
15754231|NCT04824248|Behavioral|Behavioral weight reduction program|Changes in diet, behavior and a physical exercise to reach weight loss. It will include a lifestyle approach, incorporating behavioral theories and constructs to assist and facilitate healthy energy balance related behavior.
15754232|NCT04824235|Other|Amniotic Chorion Membrane and Bio-Oss xenograft|Bioxclude Amniotic Chorion Membrane with xenograft (Bio-Oss) for ridge preservation
15754233|NCT04824235|Other|Amniotic Chorion Membrane only|Bioxclude Amniotic Chorion Membrane only
15754234|NCT04824222|Drug|Human fecal microbiota, MBiotix HBI|The FMT will be administered orally in double cover, gastro-resistant, enteric release capsules in 60g dose (about 30-50 frozen capsules).
15754235|NCT04824222|Drug|Placebo|Double cover, gastro-resistant, enteric release capsules with lactose (about 30-50 frozen capsules)
15754236|NCT04824222|Drug|SOC|The standard COVID 19 pharmacological treatment
15754237|NCT04824196|Other|vestibular visual cues therapy|Pelvic rolling to right and left with head movement and stop first on right side for 3 minutes. Do this exercise in front of the mirrorAnterior, posterior, left, and right rectilinear stimulation activities on a therapeutic ball. Anterior, posterior, left and right rectilinear
15754238|NCT04824196|Other|propriocetion exercise|"Alternate knee flexion-extension with extended trunk posture using both hands for support.
~Hip and knee flexion-extension with swiss ball between the back and wall.
~Hip raises lying with their back on the floor with both legs on the swiss ball. Upper limbs leaning on the floor to help with the exercises. then all exercise are perfomed on gym ball"
15754239|NCT04824183|Other|Music therapy|Three WhatsApp sessions will be delivered before the surgery. In the first session, participants will describe their experience with the diagnosis of breast cancer and acceptance. In the second session, participants will be educated on anxiety before their surgery, how anxiety is being managed in the hospital and self-care strategies for anxiety like MT, how to report preoperative anxiety. The third session will include postoperative pain education. The pain education will include information about the type of pain to expect after surgery, medications, pain reporting and MT for pain management. Telephone session; on the day of surgery and at 24 and 48 hours after surgery, a reminder will be sent to each participant by text message. Face-to face; MT delivery will involve the delivery of the MP3 to participant and monitoring of their use for 30 minutes both on the day of surgery and 24 and 48 hours after surgery.
15754240|NCT04824170|Other|Neural Glide|hot pack and cervical traction is applied for 10-15 min.Group A received Neural mobilization of median nerve which includes gliding and sliding was given,therapist stood on the patient & affected side besides the patient, patient'S shoulder was depressed with one hand and elbow was moved in 90 degree flexion, forearm supination, extend the wrist and fingers with other hand. Then patient arm was moved into 90 degree abduction and then sliding or gliding of nerve was applied. Sliding was applied with elbow extension and wrist flexion and elbow flexion with wrist extension. 6 sets were performed. Each set was performed for 60 seconds, for alternative days in week for 4 weeks and then progressed to gliding/tensioning technique when symptoms improved
15754241|NCT04824170|Other|Rhythmic stabilization technique|"This group was receiving (PNF) Rhythmic stabilization technique with base line treatment.
~Subject was lying in spine position on the treatment table and therapist resist an isometric contraction of agonist muscle group.pt maintain this position for 10 sec without trying to move and 12-15 repetitions were performed with 30 sec rest. Each therapeutic session treatment was focused on facilitation of neck stabilizers, improving neck stability, coordination, decreasing pain and improving postural control"
15754242|NCT04824157|Other|Non|Follow up
15754243|NCT04824144|Drug|Dexmedetomidine Hydrochloride|Dexmedetomidine will be administered by subcutaneous continuous infusion using a Continuous Ambulatory Delivery Device (CADD pump).
15754260|NCT04824092|Drug|Tafasitamab placebo|0.9% saline solution IV infusion will be administered as per the schedule specified in the respective arm.
15754261|NCT04824092|Drug|Lenalidomide placebo|Placebo matching to lenalidomide PO will be administered as per the schedule specified in the respective arm.
15754262|NCT04824079|Drug|Keynatinib|The recommended dose is 20 mg Keynatinib twice a day until disease progression， unacceptable toxicity death occurs or withdraw from the study, whichever occurs first.
15754263|NCT04824066|Device|Device: Wearable Device|A Wearable Device will be placed on the wrist of the patient ~30 days prior to the patient's scheduled surgery, removed during the operation, and replaced for ~60 days post-operatively. The device will record activity in terms of steps, sleep quality, heart rate, etc.
15754264|NCT04824053|Dietary Supplement|Milk from genetically selected homozygous- β-casein-A2 cows fed with forages and a concentrate enriched on linseed and selenized yeast as sources of PUFAs and selenium|"The daily intake should reflect habitual consumption habits in real life conditions, without forcing or inducing greater consumption. Therefore, patients will be recommended a daily intake of 250 mL of milk. The intervention duration will be 3 months"
15754265|NCT04824053|Dietary Supplement|Conventional milk|"The daily intake should reflect habitual consumption habits in real life conditions, without forcing or inducing greater consumption. Therefore, patients will be recommended a daily intake of 250 mL of milk. The intervention duration will be 3 months"
15754266|NCT04824053|Dietary Supplement|Yogurt made from milk of genetically selected homozygous- β-casein-A2 cows fed with forages and a concentrate enriched on linseed and selenized yeast as sources of PUFAs and selenium|"The daily intake should reflect habitual consumption habits in real life conditions, without forcing or inducing greater consumption. Therefore, patients will be recommended a daily intake of one yogurt. The intervention duration will be 3 months"
15754267|NCT04824053|Dietary Supplement|Conventional yogurt|"The daily intake should reflect habitual consumption habits in real life conditions, without forcing or inducing greater consumption. Therefore, patients will be recommended a daily intake of one yogurt. The intervention duration will be 3 months"
15754268|NCT04824053|Dietary Supplement|Fresh cheese made from milk of genetically selected homozygous- β-casein-A2 cows fed with forages and a concentrate enriched on linseed and selenized yeast as sources of PUFAs and selenium|"The daily intake should reflect habitual consumption habits in real life conditions, without forcing or inducing greater consumption. Therefore, patients will be recommended a daily intake of 50 g of fresh cheese. The intervention duration will be 3 months"
15754269|NCT04824053|Dietary Supplement|Conventional fresh cheese|"The daily intake should reflect habitual consumption habits in real life conditions, without forcing or inducing greater consumption. Therefore, patients will be recommended a daily intake of 50 g of fresh cheese. The intervention duration will be 3 months"
15754270|NCT04824027|Procedure|Harmonic motion imaging|Harmonic motion imaging (HMI) is a non-invasive ultrasound elasticity imaging technique that yields a quantitative relative measurement of tissue stiffness suitable for comparisons between individuals and over time. This technique induces dynamic tissue vibrations internally for tissue elasticity characterization. Participants will be asked to lie down on their back, hold still with shallow breathing while pictures/images are taken of the breast where the tumor is located using an ultrasound without any invasive procedures.
15754271|NCT04824014|Diagnostic Test|4FMFES-PET|Intravenous 4FMFES injection, followed with PET imaging
15754272|NCT04824001|Other|exercise stress echocardiography|Stress echocardiography test. The standardized exercise test was conducted by 50-W semi-recumbent cycling for 3 min. Stress echocardiograph images were acquired at the third minute of cycling to ensure that subjects had reached a steady-state HR.
15754273|NCT04823975|Behavioral|Health Insurance Education Program (HIEP)|[See arm/group description]
15754274|NCT04823962|Drug|rhGM-CSF + hydrogel|The active substance: molgramostim (rhGM-CSF)
15754275|NCT04823962|Drug|Placebo hydrogel|Placebo hydrogel
15754276|NCT04823962|Other|Standard care|Compression therapy and neutral dressings
15754277|NCT04823949|Device|Home blood pressure monitoring|See arm description
15754278|NCT04823936|Other|core stability training|core stability training program for 30 minutes including Supine abdominal draw in Abdominal draw in with double knee to chest Trunk twist while sitting on medical ball Lying supine on the medical ball and rotating the trunk to the sides Contracting abdominal muscles while lying in a supine position and pulling the limbs upward with arms and legs kept close Bringing up the arms and legs simultaneously in the prone position Bridging with head on medical ball hold this position for 3-5 s then slowly relaxes Bridging while shoulders and hands are on the floor and one leg is raised Lying supine on the medical ball and holding the abdomen in and bringing with one leg up
15754279|NCT04823923|Other|blood sampling for ITK dosage|Blood sample for ITK dosage at visit 1 (1 month +/- 1 week after the start of treatment) and at visit 2 (3 months +/- 1 month after the start of treatment)
15754280|NCT04823897|Drug|CCI-001|"Dose Escalation Phase: CCI-001 will be administered by intravenous infusion starting at 1.2mg per square metre of body surface area in the first cohort. The dose will be escalated sequentially in subsequent cohorts. The degree of dose escalation between subsequent cohorts will depend on tolerability, as judged by NCI-CTCAE grading. Once the maximum tolerated dose is determined this phase will be complete.
~Dose Expansion Phase: cohorts of patients with the following tumour types will be enrolled: transitional cell bladder cancer, pancreaticobiliary adenocarcinomas, gynecologic cancers (ovarian, cervical, endometrial), and lung adenocarcinoma. These patients will be treated at the dose determined in the dose escalation phase."
15754281|NCT04823884|Procedure|open distal chevron osteotomy|Through a 4-cm-long dorsomedial skin incision the V-shaped osteotomy with the apex 1-2 mm superior to the center of the metatarsal head is performed. The angle of the chevron is 60° to 90°. The direction of the osteotomy is angled toward the center of the third metatarsal head. After shifting the metatarsal head laterally, fixation is achieved by usage of one cannulated screw (3.0 mm or 2.5mm). Prominent bone ridges are resected with a saw. A distal soft tissue procedure is performed in every case through the same skin incision. The adductor hallucis tendon is detached from its insertion at the phalangeal bone and from the lateral border of the fibular sesamoid. The transverse intermetatarsal ligament is released and a T-shaped capsulotomy is performed to allow reposition of the sesamoids. Sesamoid position is controlled by sight. After closing of the medial capsula skin is closed with nylon sutures.
15754328|NCT04823442|Drug|Mirabegron|Mirabegron: a single dose of 200 mg mirabegron (4 tablets of 50 mg)
15754282|NCT04823884|Procedure|minimally invasive distal chevron osteotomy|The osteotomy is performed percutaneously through a dorsomedial incision of 3-5 mm. An electric motor-driven machine used for the osteotomy. To prevent overheating the reamer is frequently rinsed with sterile saline. The medial eminence is excised and the V-shaped osteotomy is performed. The apex of the osteotomy is identified by fluoroscopy and centered 1-2 mm superior to the center of the metatarsal head. The angle of the osteotomy amounts to 60-90 degrees as well. Bone debris is washed out with sterile saline. A lateral soft-tissue release is undertaken through a separate lateral incision of 3-5 mm. The distal fragment is shifted laterally and fixed with a canulated screw of 3.5mm. Residual bone ridges are reamed. Position of the metatarsal head and the K-wire is controlled by fluoroscopy. The skin is closed with a nylon sutures.
15754283|NCT04823871|Procedure|Speiser-catheter for uterine and tubal lavage|Procedure/Surgery: Lavage of the Cavum uteri and proximal Fallopian tubes, performed in the luteal phase of the female cycle
15754284|NCT04823858|Procedure|Transforaminal Lumbar Interbody Fusion|The TLIF system includes a TLIF interbody cage and a pedicle screw system (4 screws with 2 rods). Any FDA cleared TLIF interbody cage and pedicle screw system is acceptable for this study (with the exception of PEEK rods) as long as it is implanted per the package insert. No subjects implanted with an off-label use of a device are permitted for this study.
15754285|NCT04823845|Drug|Topical Adapalene Gel 0.1%|applying Adapalene Gel 0.1% to plantar warts topically
15754286|NCT04823832|Procedure|pancreaticoduodenectomy|resection of the head of pancreas and the duodenum followed by triple anastomosis
15754287|NCT04823819|Device|Magnetic Stimulator DuoMag|Stimulation of the left dorsolateral prefrontal cortex
15754288|NCT04823819|Device|neuroConn DC-STIMULATOR|One electrode (anode) will be placed on the left dorsolateral prefrontal cortex, the other (cathode) on the right temporal lobe.
15754289|NCT04823806|Dietary Supplement|Spermidine (spermidineLIFE ®) OR Placebo|21 day of 6mg spermidine OR Placebo supplementation per day
15754290|NCT04823793|Diagnostic Test|Stool DNA methylation detection|Stool specimens are collected from participants in the outpatient department or the inpatient department. Both FIT and stool DNA real-time PCR are performed simultaneously. To improve the sensitivity and specificity of the colorectal cancer screening, this study enrolls multiple candidate genes to distinguish whether the participant has a high risk of colorectal cancer.
15754291|NCT04823780|Dietary Supplement|nutrient solution|For the patients with esophageal and gastric varices after endoscopic treatment，start taking the nutrient solution at the fourth hour.
15754292|NCT04823767|Other|Single anastomosis sleeve jejunal bypass with hiatal repair|Single anastomosis sleeve jejunal bypass with hiatal repair
15754293|NCT04823754|Other|Hospitalized patient with advanced hepatocellular carcinoma receiving systemic therapy.|"Administation of two surveys to included patients, about the perception of the disease and the expectations related to the treatment.
~The physician will be asked to complete a survey on his or her perception of the prognosis and information received by the patient."
15754294|NCT04823741|Genetic|PLEURAL BIOCOLLECTION OF MALIGNANT PLEURAL MESOTHELIOMA|All patient with suspected malignant pleural mesothelioma requiring surgical biopsy after validation in oncologic multidisciplinary board will be included. During a standardized routine procedure of pleural biopsy by mean of general anesthesia and video thoracoscopic approach, 3 - 5 biopsies are realized. During this procedure, blood samples are collected and a piece of biopsy will be used for the constitution of a specific bio collection in the CRB (centre de ressources biologiques).
15754295|NCT04823728|Genetic|Autoimmune encephalitis and paraneoplastic neurological syndromes|"This is a non-interventional study involving biological samples (DNA). Samples are already stored in biobank repositories and collected as part of good clinical practice in the diagnostic process of patients with suspected autoimmune encephalitis, meaning that the standard diagnostic and therapeutic approaches will not be altered in the selected study population. Patients have already gave explicit written consent for biological specimens sampling and storage at the Centre de Ressources Biologiques des Hospices Civils de Lyon (CRB-HCL)/NeuroBioTec (including tissue, cells or biological fluids) and genetic analysis for research purposes (e.g. involving genes related to the disease for which the patient was followed). Additionally, patients will be informed about the present study."
15754296|NCT04823715|Other|TACE + hypofractionated EBRT|One cure of doxorubicin or DC Beads transarterial chemoembolization by a highly experienced interventional radiologist, followed 1 to 4 weeks later by hypofractionated external beam radiation therapy up to a total dose of 45-60 Gy, 3 Gy per fraction, 5 fractions per week, for an overall treatment time of 3 to 4 weeks.
15754297|NCT04823715|Procedure|Surgical resection|Surgical resection by open-laparotomy or laparoscopy of hepatocellular carcinoma by a highly experienced liver surgeon
15754298|NCT04823702|Biological|Aldafermin|Biological: Aldafermin (NGM282) Subcutaneous Injection
15754299|NCT04823689|Procedure|reductions|"Two reduction techniques are compared: dorsal decubitus and ventral decubitus reduction. The dorsal decubitus reduction consists in placing the patient in the dorsal position and achieving reduction by traction maneuvers on the luxated upper limb. This maneuver generally requires procedural sedation. A mild traction of the traumatized limb in the axis is performed, with slight external rotation and progressive abduction. In the absence of reduction at this stage, this gesture is completed by a flexion adduction of the limb. A counterweight is then made by a rolled sheet and passed under the armpit of the patient.
~The ventral decubitus reduction consists in placing the patient in the ventral position. The luxated limb is positioned in pendulum and the line of contact with the stretcher must pass through the mid-clavicular line. The humeral head is brought to the scapula."
15754300|NCT04823676|Dietary Supplement|Probiotic composition|Mixture of two Lactoplantibacillus plantarum strains (formerly Lactobacillus plantarum) and one Levilactobacillus brevis strain (formerly Lactobacillus brevis), in a maltodextrin carrier (E1400)
15754301|NCT04823676|Other|Placebo|Maltodextrin (E1400, qs)
15754302|NCT04823663|Device|Implant|In the scope of the CRM procedure and subsequent follow-up, the registry will provide information on the use of the Boston Scientific CRM products/components and combination of those products/components with competitor product(s) per hospital's standard of care.
15754303|NCT04823663|Procedure|Electrophysiologic procedure|In the scope of the EP procedure and subsequent follow-up, the registry will provide information on the use of the Boston Scientific Electrophysiology products/components and capital equipment products and combination of those products/components with competitor product(s) per hospital's standard of care.
15800184|NCT04449770|Device|double lumen tube|prospective cohort study
15754304|NCT04823650|Device|Actigraph|The ActiGraph CentrePoint Insight Watch is a small worn activity monitor designed for documenting physical movement associated with applications in physiological monitoring.
15754305|NCT04823637|Diagnostic Test|Ultrasonography vs Osteopathic manipulative medicine structural exam|Structural examination of the thoracic spine using ultrasound and osteopathic palpatory examination on skin.
15754306|NCT04823624|Drug|MBG453|intravenous infusion
15754307|NCT04823611|Drug|Part A:Placebo|Placebo solution
15754308|NCT04823611|Drug|Part A:AZD8233|PCSK9-targeted ASO for the reduction of circulating levels of LDL-C.
15754309|NCT04823611|Drug|Part B:Placebo|Placebo solution
15754310|NCT04823611|Drug|Part B:AZD8233|PCSK9-targeted ASO for the reduction of circulating levels of LDL-C.
15754311|NCT04823598|Procedure|Coached pushing and Finnish manual perineal protection|"Pushing technique: Rest will be encouraged between uterine contractions. With the onset of uterine contraction, women will be instructed to breathe normally. They will then be instructed to take a deep breath and hold (closed-glottis), and push down strongly for as long as possible (up to 10 seconds). After pushing effort, normal breathing will be encouraged, then the same pushing instruction will be repeated again.
~Fetal expulsion: The expulsion rate of the fetal head will be controlled by light pressure applied on the fetal occiput. Simultaneously, the thumb and index finger of the dominant hand will be used to support the perineum, while the bent middle finger will grasp the baby's chin. Once a good grip is achieved, the investigator slowly assists in the expulsion of the fetal head from the vaginal introitus. When most of the fetal head is out, the perineal ring will be pushed under the baby's chin."
15754312|NCT04823598|Procedure|Uncoached pushing and Hands-poised perineal protection|Women will not be given any instructions regarding straining and breathing, and will be allowed to follow their own pushing impulses. During the expulsion of the fetal head, the hands of the researcher will be kept in the air and ready for the intervention, but pressure will not be applied to the fetal head or perineum unless necessary (fetal hypoxic appearance, strain detection with a risk of spontaneous laceration towards the anus in the midline).
15754313|NCT04823585|Drug|Mepolizumab|Solution. Subcutaneous. Mepolizumab is a biological drug, a humanized monoclonal antibody against interleukin-5.
15754314|NCT04823585|Drug|Placebo|Solution. Subcutaneous.
15754315|NCT04823572|Procedure|A-PRF/OFD|Comparing healing effect of an autologous and open flap debridement
15754316|NCT04823559|Other|ThinkCancer workshop|The proposed intervention, the ThinkCancer! Workshop, is practice-based and consists of themed sessions for both clinical and non-clinical staff, the co-production of a Cancer Safety Netting Plan (CSNP) and the appointment of a Cancer Safety Netting Champion (CSNC). The workshop aims to raise awareness and increase knowledge around current cancer diagnosis guidance and will be delivered over half a day during GP protected time in the form of face-to-face educational sessions. Sessions will consist of a series of interactive activities exploring existing processes within practices and developing plans for change to implement each component.
15754317|NCT04823546|Other|activity based therapy|Standing and reaching (2) Sit-to-stand (3) Stepping forward and backward onto blocks (4) Stepping sideways onto blocks (5) Forward step up onto blocks (6) Raising and lowering of heel (7) Standing with the base of support constrained with feet in parallel and tandem conditions Phase 2 started after 3 weeks. Phase 2 included the phase 1 exercise along with below exercise. (10) Walking on a treadmill; (11) Walking over various surfaces and obstacles;
15754318|NCT04823546|Other|Strength Training|Strength training included for hip • flexor and extensors and abductors, knee extensors, and ankle dorsi flexors and plantar •flexors. Apart from using body weight, sandbag weights and Therabands of eight different resistances
15754319|NCT04823533|Behavioral|Gastric interoceptive training|The gastric awareness training will start with 5 minutes of sitting relaxation, followed by 500 ml of cold-water intake trying to perceive the sensations it generates while going down the esophagus and reaching the stomach. Immediately after the water intake, the participant will evaluate their experience associated with the physical sensations caused by the water intake during the task, starting at 0: no sensation until 10: very intense sensation.
15754320|NCT04823533|Behavioral|Gastric interoceptive control task|The water intake control training will start with 5 minutes of sitting relaxation but after that, the participants should drink 500 ml of room temperature water without becoming aware of the sensations that this action causes in the body, but recording the time needed to complete the intake.
15754321|NCT04823520|Drug|TCA|All patients will receive 6 sessions at 2 weeks intervals,the half face which will recieve MDA and TCA,MDA will be done before appling TCA.
15754322|NCT04823507|Device|BIOFLEX DUO+|"Data scores will be collected for patients who initially underwent the Workplace Post-Injury 1 test of the ImPACT® test system prior to PBM treatment.
~Patients were treated with photobiomodulation using the BIOFLEX® DUO+ system that utilized a 180 bulb Light Emitting Diode (LED) array followed by laser probes. Both delivery methods were applied to the cervical spine and the cranium, and both entailed the use of red light at 660 nm wavelength and near-infrared light at 830-840 nm wavelength. Treatment is provided three times per week on alternating days with weekends off for 4 weeks for a total of 12 treatments utilizing Health Canada approved device specific protocol guidelines for treatment of the cervical spine.
~Data scores will be collected for a second ImPACT® test using the Workplace Post-Injury 2 test.
~Results of the Post-Injury 1 test and the Post-Injury 2 test will be compared."
15754323|NCT04823494|Device|Hearing aids|Earbud style hearing aids fit to both ears
15754324|NCT04823468|Dietary Supplement|Abbott®Ensure|Abbott®Ensure: 55.8 g each time, three times a day, from the beginning to the end of radiotherapy
15754325|NCT04823468|Radiation|Intensity Modulated Radiation Therapy|The prescribed dose was 68-76 Gy to Planning target volume of the primary tumor (PTVnx), 66-70 Gy to Planning target volume of the cervical lymph node (PTVnd), 60-64 Gy to planning target volume 1 (PTV1), and 50-54 Gy to planning target volume 2 (PTV2) in 30-33 fractions. The details of dose limits for organs at risk were based on the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225).
15754326|NCT04823468|Drug|cisplatin|80-100 mg/m² cisplatin given intravenously every 3 weeks concurrently with radiotherapy.
15754327|NCT04823455|Procedure|fresh-frozen humeral head osteochondral allograft reconstruction for reverse Hill-Sachs lesion|Between 2001 and 2018, a total of 12 consecutive patients were surgically treated for a locked posterior glenohumeral dislocation with a humeral head defect affecting at least 30% of the head diameter. During surgery, the bone defect was substituted with a fresh-frozen humeral head osteochondral allograft.
15754330|NCT04823429|Behavioral|High intensity-interval training (HIIT)|"Subjects performed HIIT (3-min intervals at 40% and 80%VO2peak) on a bicycle ergometer for 30 min/day, 5 days/week for 6 weeks.
~Without any exercise training"
15754331|NCT04823429|Behavioral|Moderate intensity-continuous (MICT)|Subjects performed MICT (sustained 60%VO 2max) on a bicycle ergometer for 30 min/day, 5 days/week for 6 weeks.
15754332|NCT04823416|Procedure|Resection|Left hemicolectomy
15754333|NCT04823416|Procedure|Stoma|Colostomy
15754334|NCT04823403|Drug|Nivolumab|Intravenous Nivolumab (1mg/kg) will be given every 6 weeks for a maximal period of 6 months within the study.
15754335|NCT04823403|Drug|Ipilimumab|"Ipilimumab, single intra-arterial (IA) injection per patient, at 3 dose-levels*.
~(D1) Starting dose : 50 mg; n=3 to 6
~(D2) 2nd dose-level : 100 mg; n=3 to 6
~(D3) Maximal tested dose : 150mg; n=3 to 6 (if no limiting toxicities) *Dose level (D-1) : 25 mg will be tested if de-escalation is needed at D1 (>1/3 DLT at D1)"
15754336|NCT04823390|Drug|Midazolam-Fentanyl combination|Sedation is given to patients undergoing cataract surgery under local anesthesia
15754337|NCT04823377|Other|Usual care|Patients receiving systemic anticancer treatment in their last days of life
15754338|NCT04823377|Other|Optimization of the medical decision|Impact of the use of an optimization device of the decision of cancer treatment on aggressiveness of end of life care
15754339|NCT04823364|Other|Neurotransmitters evaluation by MRS|Baseline MRS screening for volunteers and ADHD groups and repeated measurement for ADHD group after taking stimulant drug treatment
15754340|NCT04823351|Behavioral|Surgical Mask|The randomized wards will be wearing either FFP2 masks or surgical masks for 8 weeks. Then a cross-over will occur for another 8 weeks.
15754341|NCT04823338|Behavioral|Conectar Jugando Online Program|Online play sessions with modern board and card games guided by the study researchers
15754342|NCT04823325|Procedure|Orthognathic Surgery|The duration for presurgical orthodontic treatment was; 7,7 ± 1,7 months.
15754343|NCT04823312|Device|Experimental prospective single arm evaluating the Medtronic Duo Extended Set|Subjects will be using 4 Duo extended sets that will serve as an exploratory pilot study to assess the 7-day survival of the Duo Extended set.
15754344|NCT04823299|Procedure|Cryoballoon ablation|Cryoballoon pulmonary vein isolation ablation
15754345|NCT04823299|Procedure|Radiofrequency catheter ablation +EPS guided trigger and substrate ablation|RF based WACA ± electrophysiological testing guided ablation of non-PV triggers of AF and low voltage area ablation
15754346|NCT04823286|Other|Virtual reality health platform during hemodialysis|Subjects will play a virtual reality game specially adapted for subjects undertaking hemodialysis. The game will also aim at providing nutritional advice, and improving psychological wellbeing and cognitive function.
15754347|NCT04823273|Behavioral|General improvement|Changes to interface to be more intuitive.
15754348|NCT04823273|Behavioral|In-line help text|General improvement + in-line help text
15754349|NCT04823273|Behavioral|Interruptive alert|General improvement + interruptive alert
15754350|NCT04823260|Drug|Nicotinamide Mononucleotide|Nicotinamide adenine dinucleotide (NAD+) is an essential cofactor in all living cells involved in fundamental biological processes. Depletion in the levels of NAD+ is associated with traits of aging, many age-related diseases like cancer, metabolic disorders and neurological disorders. Evidence stemming from recent studies have unveiled numerous roles of NAD+ metabolism on aging and longevity and delaying the progression of age-related diseases
15754351|NCT04823260|Other|Placebo|Rice flour in white capsule resembling NMN
15754352|NCT04823247|Drug|Tildrakizumab|As provided in real world clinical practice.
15754353|NCT04823234|Diagnostic Test|Lung ultrasound|Lung ultrasound signs in Covid 19 positive pregnant patients
15754354|NCT04823221|Device|Rezūm System|The basic principle of the Rezūm System is to deliver a controlled amount of sterile water vapor directly into the hyperplastic tissue in the transition zone of the prostate using a transurethral approach .The stored thermal energy in the vapor is transferred directly onto the cell membranes as the vapor condenses and releases the heat of condensation, causing cell death. Inaddition, this thermal energy transfer collapses the vasculature within the treatment zone, resulting in a bloodless procedure. During procedure the water vapor is created by a heating element in the Rezūm Delivery Device,Saline flush during vapor delivery protects and preserves the urethra.
15754355|NCT04823208|Drug|LY3437943|Administered SC
15754356|NCT04823208|Drug|Placebo|Administered SC
15754357|NCT04823182|Diagnostic Test|Cardiovascular Magnetic Resonance Imaging|The Cardiac MRI protocol consists of static T2 weighted in all three planes and T2 weighted imaging with fat saturation in the short axis plane.
15754358|NCT04823169|Other|podobarometry|podobarometric measures on day 7 and day 30
15754359|NCT04823156|Dietary Supplement|Calcium|Daily calcium food supplement.
15754360|NCT04823156|Dietary Supplement|Low Energy Availability|Restriction of dietary energy intake.
15754361|NCT04823130|Drug|Dupilumab SAR231893|Pharmaceutical form: solution for injection Route of administration: subcutaneous
15754362|NCT04823117|Other|music therapy|music includes nature sounds recommended by the Turkish Psychological Association
15754363|NCT04823104|Other|Home visitation|Home visitation for pregnancy follow-up
15754364|NCT04823091|Drug|Fludarabine + Cyclophosphamide + CAR7-T Cells|fludarabine 30 mg/kg on day -5, -4, and -3; cyclophosphamide 250 mg/kg on day -5, -4, and -3; CAR7-T Cells on day 0, 1, and 2.
15754365|NCT04823078|Other|Activity base therapy|"activity based therapy
~Weight bearing activities of daily living like vertical lifting, bilateral body weight shifting, lifting and shifting, forward reaching and sideways reaching."
15754366|NCT04823078|Other|Strength training|Strengthening exercises of upper limb involved muscles (elbow extensors, shoulder adductors, abductors, wrist extensors, shoulder protractors and retractors
15754367|NCT04823065|Drug|Loperamide Pill|4 mg Imodium, per os
15754368|NCT04823065|Drug|hyoscine-n-butylbromide|3 X 20 mg Buscopan, intravenous
15754369|NCT04823052|Drug|Sulindac, dose strength 1|Sulindac Capsule
15754370|NCT04823052|Drug|Sulindac, dose strength 2|Sulindac Capsule
15754371|NCT04823052|Drug|Placebo|Placebo Capsule
15754372|NCT04823039|Other|Blood sample taken|For patients with sepsis who require vaccination during hospitalization, we will analyze the immunogenicity of pneumococcal conjugate vaccine (PCV13) by taking blood samples
15800386|NCT04447820|Drug|K-877-ER (Dose A)|Dose A Oral Administration
15754373|NCT04823013|Other|high power pain threshold ultrasound which the dose was kept constant|Participants in HPPT-US 1 group received the HPPT-US treatment. The intensity was gradually increased from 0.5 W/cm² to the pain threshold level at which the patient verbally reported the pain. The therapist kept the intensity at that level for 5 s, and then moved the US transducer in a circle without the change of the intensity for 15 s. The procedure was repeated 3 times. The patients were asked whether serious pain or any abnormal sensation was felt during HPPT-US. The intensity was varied from 0.5 to 1.2 W/ cm².
15754374|NCT04823013|Other|high power pain threshold ultrasound which the dose reduced to one half|Participants in HPPT-US 2 group also received the HPPT-US treatment. The intensity was gradually increased from 0.5 W/cm² to the pain threshold level at which the patient verbally reported the pain. The therapist kept the intensity at that level for 5 s, then reduced the dose half and moved the US transducer in a circle for 15 s. The procedure was repeated 3 times. The patients were asked whether serious pain or any abnormal sensation was felt during HPPT-US. The intensity was varied from 0.5 to 1.2 W/ cm².
15754375|NCT04823013|Other|ischemic compression|Participants in IC group received ischemic compression therapy. The technique was applied in the sitting position to participants. Ischemic compression was performed by compressing trigger points identified by palpation with tolerable intensity using thumb. The duration for each trigger points was 1 minute. Then the muscle containing the trigger point was applied intramuscular stretching for 30 seconds by therapist
15754376|NCT04823000|Biological|Mesenchymal Stem Cells (MSC)|Repeated intrathecal and intravenous injection of autologous mesenchymal stem cells (1 million cells per Kg of body weight) at 6 months intervals.
15754377|NCT04822974|Other|blood collection|longitudinally collection of blood samples for each patient included.
15754378|NCT04822961|Drug|Placebo|Senaparib-matched placebo capsules
15754379|NCT04822961|Drug|Senaparib|20 mg capsules
15754381|NCT04822922|Genetic|Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs)|The hUC-MSCs were injected intravenously on the 1, 4, 7 and 10 days after patients recruitment. The treatment doses include low dose: 4*10^5 cells/kg/each time, and medium dose: 8*10^5 cells/kg/each time, high dose 12*10^5 cells/kg/each time. After 3 groups of patients were enrolled, the group with appropriate safety and effectiveness was selected and the other 4 subjects were included.
15754382|NCT04822909|Drug|Apremilast;Apremilast;Apremilast 10 MG; 20 MG; 30 MG Oral Tablet|"The study patients will be treated with oral apremilast, administered initially a dose of 10 mg once daily, gradually increasing to reach the maximal therapeutic dosage of 30 mg twice daily before end of 1st week of starting the therapy.
~The treatment will be continued till 6 months and we will taper the steroids by 10mg/ 2 weeks till 20mg and then 5 mg/ 2 weeks till discontinuation of steroids.
~If a patient worsens after treatment or develops any serious adverse event after initiation of treatment, he will be withdrawn from the study.
~If there is no response to the treatment and we are unable to taper steroids after 12 weeks of therapy then the patient will be withdrawn from the study"
15754383|NCT04822896|Behavioral|Physical Exercise|"The videos will be prepared by the researchers and will be watched by the physical exercise group, which includes exercises such as shifting the jaw to the side, pushing the tongue forward, jaw opening, sliding the jaw with the tongue, opening the chin with the tongue, opening the chin by pressing the tongue against the palate and shifting the chin with the person's own resistance. Then they will be asked to do the exercises physically. Each exercise will be applied as 2 sets x 10 repetitions. There will be a 30-second break between sets."
15754384|NCT04822896|Behavioral|Kinesthetic Motor Imagery Exercises|"Seven exercises designated as jaw shifting, tongue pushing forward, jaw opening, jaw shifting with tongue, jaw opening with tongue, jaw shifting by pressing the tongue on the palate, and chin shifting with one's own resistance, the videos prepared by the researchers and containing these exercises Once viewed, it will be applied as kinesthetic imagery. Each exercise will be applied as 2 sets x 10 repetitions. There will be a 30-second break between sets."
15754385|NCT04822896|Behavioral|Visual Motor Imagery Exercises|"Seven exercises designated as jaw shifting, tongue pushing forward, jaw opening, jaw shifting with tongue, jaw opening with tongue, jaw shifting by pressing the tongue on the palate, and chin shifting with one's own resistance, the videos prepared by the researchers and containing these exercises Once viewed, it will be applied as visual imagery. Each exercise will be applied as 2 sets x 10 repetitions. There will be a 30-second break between sets."
15754386|NCT04822883|Drug|RL-007|Cohorts are 10 mg, 20 mg, 40 mg, and 80 mg with TID dosing
15754387|NCT04822883|Drug|RL-007 Matching Placebo|Cohorts are 10 mg, 20 mg, 40 mg, and 80 mg with TID dosing
15754388|NCT04822870|Procedure|quadratus lumborum block|Quadratus lumborum block is an effective nerve block method in post-cesarean section analgesia. It is a relatively new technique that may provide analgesic effect in somatic pain and visceral pain, but has not been verified yet.
15754389|NCT04822870|Procedure|iliohypogastric/ilioinguinal nerve block|Iliohypogastric/ilioinguinal nerve block is a widely used nerve block technique. It can provide somatic analgesia effect in post-cesarean section.
15754390|NCT04822870|Procedure|epidural analgesia|Epidural analgesia is a traditional analgesia method. Epidural morphine can provide effective analgesia but may cause plenty adverse effect.
15754391|NCT04822857|Diagnostic Test|AMH|The group was divided according to the level of Anti-Müllerian Hormone
15754392|NCT04822844|Other|Lavender Essential Oil|Within 5 minutes of arrival at the PACU, the PACU nurse will proactively offer the patient a 2x2 gauze with two drops of essential oil (patient's choice of ginger or lavender essential oil) for all patients who have opted to participate, regardless of their nausea and vomiting status. Participating patients will continue to use the essential oil during their stay in the PACU, which is typically 45-60 minutes.
15754393|NCT04822844|Other|Ginger Essential Oil|Within 5 minutes of arrival at the PACU, the PACU nurse will proactively offer the patient a 2x2 gauze with two drops of essential oil (patient's choice of ginger or lavender essential oil) for all patients who have opted to participate, regardless of their nausea and vomiting status. Participating patients will continue to use the essential oil during their stay in the PACU, which is typically 45-60 minutes.
15754394|NCT04822831|Behavioral|45 Degree Semi-recumbent Position With Upper Limb Exercise Training|The experimental group was given 45 degree Semi-sitting 2 hrs and upper-limb exercise training 10 mins once a day, and this intervention kept 4 weeks.
15800387|NCT04447820|Drug|K-877-ER (Dose B)|Dose B Oral Administration
15754395|NCT04822831|Behavioral|no 45 Degree Semi-recumbent Position With Upper Limb Exercise Training|The control group was with usual treatment.
15754396|NCT04822818|Drug|BEVA+SOC|Bevacizumab : 7.5 mg / kg (with a maximum of 750 mg) on day 1 (D1) SOC : patients will receive the best of standard of care including corticosteroids, anticoagulant, antibiotics and tociluzimab
15754397|NCT04822818|Drug|SOC|patients will receive the best of standard of care including corticosteroids, anticoagulant, antibiotics and tociluzimab
15754398|NCT04822805|Drug|Anlotinib hydrochloride|Patients with recurrent high-grade gliomas are being enrolled , treated with anlotinib 12mg once daily for 14 days every 3 weeks until disease progression or unacceptable toxicity.The dose can be adjusted to 10mg or 8mg according to the specific conditions of the patient.
15754399|NCT04822792|Device|Multi-cancer early detection test|Blood collection and multi-cancer early detection test
15754400|NCT04822779|Device|Sonopuls 490u, Enraf-Nonius, Rotterdam, Kingdom of the Netherlands|"Ultrasound therapy will be applied in continuous output, 1 MHz frequency, the intensity of 1.5 W / cm2, and duration 10 min per treatment, on the front of the shoulder, on the surface of 2 ultrasound heads (10 cm2).
~The position of the arm will be in adduction and internal rotation in RCT of the supraspinatus, adduction and external rotation of the arm in RCT of the subscapularis, and the position of the arm over the opposite shoulder in RCT of the infraspinatus."
15754401|NCT04822779|Other|Placebo|"Sham ultrasound therapy will be applied using a frequency of 0 Hz, intensity 0 W / cm2, 10 min per treatment.
~The position of the arm will be in adduction and internal rotation in RCT of the supraspinatus, adduction and external rotation of the arm in RCT of the subscapularis, and the position of the arm over the opposite shoulder in RCT of the infraspinatus."
15754402|NCT04822766|Procedure|Hematopoietic stem cell transplantation|patients will undergo allo-HSCT after consolidation therapy (or completion of other appropriate non-palliative strategy) according to standard procedures of the transplant center (choice of donor, conditioning regimen, GVHD and infection prophylaxis). The use of novel therapies (such as sorafenib, midaustorine, venetoclax, etc.) will be allowed as post-transplantation maintenance strategy.
15754403|NCT04822766|Drug|Best chemotherapy treatment|patients will be treated according to the standard procedures of the treating center for this type of population. Patients will receive the best available treatments (including additional conventional chemotherapy or other non-palliative therapies such as 5-azacytidine, decitabine, venetoclax, midaustorine, enasidenib, etc.).
15754405|NCT04822740|Device|Control Glucose Monitoring System|"With a sensor, transmitter and display device (receiver and/or compatible smart device).
~The CGMS sends glucose readings to a compatible smart device every 5 minutes. In this study the CGMS for all patients with use of the results of the device in real time by the health care team for the Experimental arm and without the use of the results by the health care team for Active Comparator (Conventional strategy ."
15754406|NCT04822727|Device|1 or more AndraTec devices (see description for list of devices)|1 or more AndraTec devices (Lokum L-Quest guidewire, Lokum Amplatz guidewire, Slider Hydrophilic Nitinol Guidewire, AltoSa-XL PTA Balloon, Alto-Sa-XL Gemini Balloon, Optimus-CoCr stent, Optimus-CVS PTFE covered stent)
15754407|NCT04822714|Behavioral|Mobile Career Competencies Intervention|Mobile career competencies intervention aim to enhance the career competencies (career behavioral action) among the participants
15754408|NCT04822701|Drug|BI 767551 intravenous|BI 767551 intravenous
15754409|NCT04822701|Drug|BI 767551 inhaled|BI 767551 inhaled
15754410|NCT04822701|Drug|Placebo intravenous|Placebo intravenous
15754411|NCT04822701|Drug|Placebo inhaled|Placebo inhaled
15754412|NCT04822688|Procedure|Biospecimen Collection|Undergo collection of tissue and blood samples
15754413|NCT04822675|Procedure|Percutaneous mitral valve repair|Percutaneous mitral repair will be performed using the MitraClip system.
15754414|NCT04822675|Procedure|Surgical mitral valve repair/replacement|All mitral valve surgeries will be performed either via sternotomy or right thoracotomy, and with cardioplegic arrest and cardiopulmonary bypass. Mitral valve repair may include annuloplasty and adjunctive procedures as determined by the operating surgeon. For mitral valve replacement, the choice of mitral valve prosthesis will be left at the surgeon's discretion.
15754415|NCT04822662|Behavioral|Epilepsy Education Programme|Firstly the Child Introduction Form and Parent Information Form were applied. Then the Child's Attitude Towards Self-Disease Scale, Seizure Self-Efficacy Scale for Children, Quality of Life Scale for Children were filled to children. Nurse-Parent Support Scale were applied to the parents in the Pretest and Post Test data.
15754416|NCT04822649|Diagnostic Test|Adenosine stress echocardiography with the evaluation of coronary artery blood flow|"The color Doppler flow of distal left anterior descending artery will be examined from the modified apical four-chamber view in the anterior interventricular groove.
~In regard to body composition analysis, Using InBody S10, impedance is measured in 6 frequency bands (1kHz, 5kHz, 50kHz, 250kHz, 500kHz, 1000kHz) for each of 5 parts (right plate, left arm, torso, right leg, left leg). Reactance is measured in 3 frequency bands (5kHz, 50kHz, 250kHz for each of 5 parts (right arm, left arm, torso, right leg, left leg).
~By treadmill exercise test with modified Bruce protocol or bicycle ergometer for patients with orthopedic problems, maximal oxygen consumption (VO2 max) will be measured using the exhalation gas analysis."
15754417|NCT04822636|Behavioral|Family-based mental health navigation|Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement
15754418|NCT04822636|Behavioral|Standard of care engagement practices|Standard of care engagement practices and services- as-usual
15754419|NCT04822623|Diagnostic Test|MRI|MRI examination
15754422|NCT04822597|Drug|Lidocaine patch|Lidocaine is a local anesthetic.
15754423|NCT04822597|Device|Buzzy(R)|Buzzy provides non-invasive pain relief by vibrating and cooling the skin which distracts from pain sensations.
15754424|NCT04822597|Other|Ice pack|Ice cools the skin and can provide some numbing for pain.
15754425|NCT04822584|Drug|Baricitinib Oral Product|Baricitinib 4 mg/day orally for 36 weeks
15754426|NCT04822584|Drug|Placebo|Placebo once a day orally for 36 weeks
15800388|NCT04447820|Drug|K-877-IR|K-877-IR Oral Administration
15754427|NCT04822571|Other|Reliability of 3D motion analysis protocol|The intrinsic and extrinsic reliability of the designed 3D motion analysis protocol is measured in cases of high velocity dynamic movement such as kicking a soccer ball.
15754428|NCT04822558|Other|Plantar pressure measurement|Biomechanical and clinical evaluation of the reconstructive procedures of ankle and hindfoot using a 3D multisegment foot model
15754429|NCT04822558|Other|Gait analysis|Biomechanical and clinical evaluation of the reconstructive procedures of ankle and hindfoot using a 3D multisegment foot model
15754430|NCT04822558|Procedure|Ankle and hindfoot reconstruction surgery|Ankle and hindfoot reconstruction surgery
15754431|NCT04822545|Other|referral to comprehensive weight management clinic|"Patients will receive a referral for outpatient CWM clinic, with a message sent to the CWM clinic scheduler, prior to hospital discharge.
~At six months after discharge, the patient will receive a phone call from the investigators to ascertain whether they were able to go to the CWM clinic and about their experience."
15754432|NCT04822532|Genetic|GSTA1 genotyping|Diplotype determination based on 4 single-nucleotide polymorphisms (SNPs) occurring in the promoter region of the GSTA1 gene
15754433|NCT04822506|Procedure|Routine perioperative management and PEA|Routine perioperative management： All patients were given perioperative fluid rehydration and nutritional support to correct acid-base imbalance, electrolyte disturbance, anti-infection, hemostasis and other symptomatic treatment； electroacupuncture protocol： Preoperation:RN 6 + RN 4 +ST30 + ST 36+ Hegu (bilateral),De qi, electroacupuncture, continuous wave, 5Hz, 30min before surgery at 19:00 PM Inoperatively: LI 4+ PC 6 + ST36 + GB 34 (bilateral) ,Deqi, electroacupuncture with density wave, 2/100Hz, 30 minutes before operation to the end of the operation Postoperative: LI 4 +SJ 6 + ST 6 + ST 37(Left);LI 4 +SJ 6 + ST 6 + ST 37(Right)(alternated on both sides per 12h) Deqi, electroacupuncture, continuous wave, 5Hz, 30min,19:00 on the left side and 07:00 on the next day after surgery,until to first flatus (FF)
15754434|NCT04822506|Procedure|Routine perioperative management and postEA|Routine perioperative management： All patients were given perioperative fluid rehydration and nutritional support to correct acid-base imbalance, electrolyte disturbance, anti-infection, hemostasis and other symptomatic treatment； electroacupuncture protocol： Postoperative: LI 4 +SJ 6 + ST 6 + ST 37(Left);LI 4 +SJ 6 + ST 6 + ST 37(Right)(alternated on both sides per 12h) Deqi, electroacupuncture, continuous wave, 5Hz, 30min,19:00 on the left side and 07:00 on the next day after surgery,until to first flatus (FF)
15754435|NCT04822493|Other|Counseling Aid|Women will watch an educational video regarding expectations for delivery and postpartum care in addition to receiving standard care and counseling.
15754436|NCT04822480|Behavioral|Diabetes Prevention Program (DPP)|Individuals with prediabetes can mitigate the risks and costs of diabetes by taking preventative action, such as participation in a National Diabetes Prevention Program (DPP). The DPP began as a multisite randomized controlled trial demonstrating the effectiveness and cost-benefit of a 12-month intensive lifestyle intervention over pharmaceutical treatment for preventing or delaying diabetes among prediabetic participants. In 2010, Congress authorized the Centers for Disease Control and Prevention to lead the dissemination of the DPP as a targeted approach (high risk populations) and population-based strategy to reduce the incidence of diabetes and diabetes-related healthcare costs. The goal is to achieve modest weight loss (7%) by developing and implementing behavior change skills resulting in lifestyle modifications such as physical activity (150 minutes per week) and dietary and nutritional practices.
15754437|NCT04822467|Device|SQ53 Wipe|SQ53-based wipe to be used by the participant daily or upon dressing change
15754438|NCT04822467|Device|Ethanol Wipe|Ethanol-based wipe to be used by the participant daily or upon dressing change
15754439|NCT04822454|Other|Night shift shadowing program|Our population, made up of 70 students, was divided into two randomly randomized groups: 31 (44.3%) had five night shift shadowing duty prior to their first official night shifts, and 39 (55.7%) did not participate in the shadowing program.
15754440|NCT04822441|Other|data collection|Ultrasound follow-up maternal dengue serology PCR (Polymerase Chain Reaction) and dengue serology of the umbilical cord
15754441|NCT04822428|Other|Osteopathic manipulation|Osteopathic manipulative techniques including; suboccipital release technique,sacral release technique, diaphragmatic release, mesentery release, and Colonic manipulation
15754442|NCT04822415|Drug|Mepivacaine|IANB using 3.6 ml of 2% mepivacaine hydrochloride with 1:100,000 epinephrine.
15754443|NCT04822415|Drug|Articaine|IANB using 3.4 ml of 4% articaine hydrochloride with 1:100,000 epinephrine.
15754444|NCT04822389|Device|Telerehablitation using heart rate monitor|Eligible participants will undergo 12 weeks of physical exercise using a heart rate monitor and internet platform at home. The participants will regularly (minimum once per week) upload the exercise data from the heart rate monitor into the internet platform. An exercise telerehabilitation session consists of the warm-up phase, aerobic phase (30 - 50 minutes gradually increasing exercise duration; heart rate zone based on baseline cardiopulmonary exercise test) and cool-down phase. The exercise training period is set to 3 times a week for 12 weeks. Study participants will receive user guides developed by research team with detailed instructions regarding equipment set-up, training protocol, and contact information. Also, participants will receive weekly phone calls from week 0 to week 12 to monitor adverse events, encourage compliance and adherence to the study protocol, address any subject questions or concerns, and collect information regarding participants' current symptomatology.
15754445|NCT04822376|Drug|ansuvimab|Human monoclonal antibody to Zaire strain GP (EBOV GP)
15754446|NCT04822376|Biological|Ervebo|Ebola Zaire vaccine (rVSV∆G-ZEBOV-GP, live, attenuated) ≥ 72 million PFU, composed of the Indiana strain of recombinant vesicular stomatitis virus (rVSV) with a deletion of the envelope glycoprotein (G) of VSV replaced by the surface glycoprotein (GP) of the Kikwit 1995 strain of Ebola virus Zaire (ZEBOV)
15754447|NCT04822363|Drug|Aspirin|Low dose aspirin in Arms A and D and High Dose Aspirin in Arm B
15754448|NCT04822363|Drug|Clopidogrel|Arms C and E
15754449|NCT04822350|Drug|Avelumab|As provided in real world practice
15754450|NCT04822337|Drug|Carfilzomib, Lenalidomide, Dexamethasone, Belantamab Mafodotin|Phase I - Chemotherapy multiple agents systemic Phase II - Maximum Tolerated Dose from Phase I
15754556|NCT04821388|Device|Rontis DCB|"The Rontis DCB is intended for use as a percutaneous transluminal angioplasty (PTA) catheter to dilate stenotic or obstructive vascular lesions in the lower extremities for the purpose of improving limb perfusion and decreasing the incidence of restenosis.
~In this study, it is intended to use Rontis DCB for treatment of lesions in the femoropopliteal arteries"
15754451|NCT04822324|Other|Spencer Muscle energy technique with conventional Physiotherapy|"shoulder extension with elbow flexion. shoulder flexion with elbow extension. circumduction with compression circumduction with distraction shoulder abduction and internal rotation with elbow flexion. shoulder adduction and external rotation with elbow flexion stretching tissue and pumping fluids with the arm extended: therapist interlocks his fingertips over the deltoid muscle, patient's hand was placed over the therapist shoulder, and the therapist slowly moved the arm away from the shoulder and released.
~During all the movements patient is asked to use their muscle energy against the slight resistance offered by the therapist for 6-8 sec.
~conventional therapy Joint mobilization
~Exercise therapy:
~Self stretching and strengthening exercises"
15754452|NCT04822324|Other|Strain counter strain along with conventional Physiotherapy and Spencer Muscle energy technique|"Palpate surrounding and opposing tissues to locate tender point for both shoulder abduction and external rotation.
~Use one or two finger pads to monitor fasciculation and TP. Fine-tune position with rotation. Hold the POC (position of comfort) until fasciculation decreases significantly or ceases.
~Average positions hold time while pressure is 90 s to 3 min. Transient periods of brief tingling, numbness, and temperature changes might occur. Release tissue or joint slowly and reassess."
15754453|NCT04822311|Behavioral|Experimental: Investigate the effects of an exercise intervention on retired APF players|Enrolled participants will perform a 18 months exercise intervention which involves 90 exercise rehabilitation training visits. In addition, participants will also be tested on various measures of health and function both at baseline (prior to intervention), at 6 months, 12 months, and 18 months (post intervention).
15754454|NCT04822298|Drug|AMG 160|AMG 160 administered as an intravenous (IV) infusion
15754455|NCT04822285|Behavioral|Psychological Triaging Intervention|The PTI intervention followed the path of RAPID Psychological First Aid model of John Hopkins University (Everly& Lating 2012). The content of the PTI represents a simple structure that is revolved around five core phases including (R: establishing rapport and reflective listening, A: assessment, P: prioritization, I: intervention and D: disposition& follow up).
15754456|NCT04822285|Behavioral|Routine psychological support|For the comparison group, the researchers provided them with routine psychological support that mainly revolved around enhancing their self-compassion, practicing mindfulness exercises, keeping them socially connected with their family and peers. Moreover, adopt a healthy lifestyle such as; engage in physical activity, eating a well-balanced diet, and sleeping well.
15754457|NCT04822272|Device|MRI thermometry|MRI sequence of 5 to 10 minutes to measure the variation of temprerature in the prostate
15754458|NCT04822259|Device|JOURNEY II BCS Total Knee System|Undergoing Total Knee Replacement(resurfaced patella) with JOURNEY II BCS Total Knee System
15754459|NCT04822259|Device|JOURNEY II CR Total Knee System|Undergoing Total Knee Replacement(resurfaced patella) with JOURNEY II CR Total Knee System
15754460|NCT04822246|Procedure|Control: Hand instrumentation for caries excavation|"An enamel hatchet will be used to create access to the carious lesion and then removal of soft carious tissue will be undertaken with excavators. Excavation will be stopped when some resistance to excavation will be felt and the cavity will be then conditioned with polyacrylic acid for 20 s, washed and dried with cotton pellets. A high-viscosity glass-ionomer cement will be used to restore the cavity. Moisture control will be achieved with the use of cotton wool rolls. A chair-side assistant will hand-mix the glass-ionomer according to manufacturers' instructions and it will be placed in the cavity using the press-finger technique whenever the type of cavity allows it. In the case of root restorations, a glove coated with petroleum jelly will be used similarly to the press-finger technique to better condense the material into the cavity. Excess material will be removed; the restoration will be coated with petroleum jelly. No local anaesthetic will be used to provide ART treatment."
15754461|NCT04822246|Procedure|Intervention 1: EMS Airflow device for caries excavation|An enamel hatchet will first be used to gain access into the cavity. Then the powder-water prophylaxis device will be used for the removal of soft carious tissue with the sodium bicarbonate powder-water jet. Excavation will be stopped when the colour of the lesion begins to darken and all the soft deposits are evacuated. The excavation will be done intermittently allowing sufficient time to check with hand instrument the surface hardness of the lesion. If the lesion is still soft excavation will be continued until the surface is hard suitable for restoring. The cavity will be then rinsed with copious water spray to evacuate all the powder-water material. The restoration procedure with a glass-ionomer cement will be done following the same procedures as in the control group.
15754462|NCT04822246|Procedure|Intervention 2: Hand excavation + EMS Airflow device for caries excavation|The participants allocated to this group will have the caries excavated as described for the control group. Then prior to filling the excavated cavity, the procedure of sodium bicarbonate powder-water jet irrigation as described for the intervention group #1 will be performed to condition the prepared excavated cavity. Then the restorative procedure will be completed with the restorative material and procedures as described for the previous groups.
15754463|NCT04822233|Device|Hall Technique (HT)|Prior to each restoration, a bacterial sample of the lesion will be obtained with a cotton swap and dispensed in a transport medium for microbial analyses.The preformed metal crown (PMC) will placed without local anesthetic and without crimping or trimming. When the contact points are tight, an orthodontic elastic separator will be placed for 2 hours prior to PMC placement. The PMCs will be cemented with glass ionomer Ketac cem.
15754464|NCT04822233|Device|Modified Hall Technique (MHT)|Prior to each restoration, a bacterial sample of the lesion will be obtained with a cotton swab and dispensed in a transport medium for microbial analyses.This group will in addition to all the procedures for the Hall will have the Caries lesions treated with 30% Silver Diamine Fluoride (SDF) before cementation of the stainless-steel crowns.
15754465|NCT04822233|Device|Conventional Technique (CT)|Prior to each restoration, a bacterial sample of the lesion will be obtained with a cotton swab and dispensed in a transport medium for microbial analyses. Conventional occlusal, proximal slicing and when necessary buccal and lingual surfaces will be carried out under local anesthesia and dental dam isolation local anesthesia.The PMC will be trimmed and crimped at the gingival margin to improve the fit, and cemented with Ketac cem.
15754466|NCT04822220|Other|Fatigue Self-management Programme|Fatigue Self-management Programme
15754467|NCT04822207|Procedure|acupuncture|Patients undergo acupuncture at the beginning of embryo transfer cycle three times a week until 14 days after embryo transfer. Every acupuncture lasts 20 minutes.
15754468|NCT04822194|Behavioral|Cognitive Emotion Regulation Training|Cognitive emotion regulation training via cognitive reappraisal involves the ability to modify the trajectory of an emotional response by thinking about and appraising emotional information in an alternative, more adaptive way. Reappraisal to down-regulate negative emotion can be operationalized via two tactics: psychological distancing and reinterpretation. The current study will randomly assign participants to receive a brief course of reappraisal training using either psychological distancing or reinterpretation.
15754471|NCT04822168|Other|MySafeRx™|The MySafeRx™ platform is a combination of several key components, including daily videoconferencing check-ins with motivational interviewing-based recovery coaching, text-messaging reminders, secure storage of B/N medication within a secure electronic pill dispenser, and a standardized protocol for supervising self-administration of medication via videoconferencing.
15754472|NCT04822168|Other|Standard Care|Standard Care through office-based opioid treatment with B/N dosing, on-site counseling and regular urine toxicology screening
15754473|NCT04822129|Behavioral|Treatment as Usual|Treatment as usual will provide participants with basic information that is readily available as well as the encouragement to develop a brain health program that may be available from medical professionals.
15754474|NCT04822129|Behavioral|Cogtrastim Model|The study intervention for this group will include a review of the Cogtrastim model and explicit discussion of the possible mechanisms of action of various activities that have been shown to be associated with better health in general and, where supported by evidence, better mental functioning in older persons. Persons in this group will be encouraged to select brain health activities based on the model.
15754475|NCT04822116|Other|goal directed intraoperative haemodynamic optimization|all interventions that were pre-specified to be administered as part of the protocol
15754476|NCT04822090|Other|Supportive treatment with or without red cell transfusion/intravenous immune globulin (IVIG)|red cell transfusion; plasma exchange; renal replacement therapy; intravenous immunoglobulin. plasma exchange
15754477|NCT04822077|Radiation|Proton radiation|"Patients with radical surgery and unfavourable histology (B2, B3, C) and/or Masaoka-Koga stage III, IVa: 2 Gy(RBE), once daily, five days a week to a total dose of 50 Gy(RBE).
~Patients with non-radical surgery (R1 resection) regardless of stage and histology: 2.3 Gy(RBE), once daily, 5 days a week to a total dose of 57.5 Gy(RBE)
~Inoperable patients regardless of stage and histology and patients with R2 non-radical resection: 2.5 Gy (RBE), once daily, 5 days a week to a total dose of 62.5 Gy(RBE)"
15754478|NCT04822064|Drug|Intranasal dexmedetomidine and ketamine|Additional intranasal administration of dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) to induce rescue sedation (pediatric sedation state scale = 1,2,3) after failed sedation attempt (PSSS=4,5) with oral chloral hydrate (50mg/kg)
15754479|NCT04822064|Drug|Oral chloral hydrate|Additional oral chloral hydrate (50mg/kg) administration to induce rescue sedation (pediatric sedation state scale = 1,2,3) after failed sedation attempt (PSSS=4,5) with oral chloral hydrate (50mg/kg)
15754480|NCT04822051|Other|The Uncertainty Management Psychoeducation Program|The program is conducted in the form of individual psychoeducation. The training was planned to include a total of five sessions, with 60 minutes for each session once a day, and at least two sessions a week. At least two days of a gap was decided between two consecutive sessions.
15754481|NCT04822038|Dietary Supplement|Vitamin D3|5000 UI Vitamin D3 daily by 4 weeks
15754482|NCT04822038|Other|Dietary recommendations|Dietary recommendations based on food rich in 25 (OH) vitamin D
15754483|NCT04822025|Biological|MVC-COV1901 (High-Dose)|Approximately 300 participants will receive 2 doses of MVC-COV1901(S-2P protein with adjuvant) at Visit 2 (Day 1) and Visit 4 (Day 29) via intramuscular (IM) injection in the deltoid region
15754484|NCT04822025|Biological|MVC-COV1901(Mid-Dose)|Approximately 100 participants will receive 2 doses of MVC-COV1901(S-2P protein with adjuvant) at Visit 2 (Day 1) and Visit 4 (Day 29) via intramuscular (IM) injection in the deltoid region
15754485|NCT04822012|Diagnostic Test|Anti COVID19 IgG Antibodies|Detection of antibodies to SARS Cov 19 post infection or vaccination , measurements of female hormones in folicular fluid as compared to serum and Perlecan as a follicular quality marker
15754486|NCT04821999|Device|a 940-nm diode laser|a 940-nm diode laser (EPIC™, BIOLASE, www.biolase.com) with an adjustable pain therapy handpiece capable of creating diffuse laser energy patterns ranging from 15 mm to 30 mm in size.
15754487|NCT04821973|Device|Radius PPG Tetherless Pulse Oximetry (Masimo)|continuous monitoring by a portable, wireless and stand-alone device
15754488|NCT04821973|Device|usual monitoring|usual nurse respiratory monitoring
15754489|NCT04821960|Behavioral|Tailored Mindfulness Program for Fear of Memory Loss|The tailored mindfulness program has been specifically created to focus on fear of memory loss compared to general mindfulness lessons and activities.
15754490|NCT04821960|Behavioral|Conventional Mindfulness Program|Routine non-tailored mindfulness lessons and activities.
15754491|NCT04821947|Other|Rhomboid intercostal plane block or Local anesthetic infiltration of 0.25% Bupivacaine|"for RIB GroupThe following structures will be identified from superficial to deep: trapezius muscle, rhomboid major muscle, intercostal muscles between ribs, pleura, and lung. The tissue plane between the rhomboid major and intercostal muscles will be identified. A 18 gauge Tuohy needle will be advanced in plane from a superomedial-to-inferolateral direction, through the trapezius and rhomboid major muscles. The skin entry point for the first injection will be the T5-T6 level just medial to the scapula.
~After the location is confirmed through hydrodissection of 3 ml on the upper intercostal muscles under the rhomboid major muscle, 20ml of bupivacaine (concentration 0.25%) is injected under rhomboid major muscle LA group will receive wound infiltration of VATS incision single-incision with 10mL 0.25% bupivacaine double-incision with 15 mL (10mL+5mL) 0.25% bupivacaine three-port strategy with 17 mL (10mL+5mL+2mL) 0.25% bupivacaine"
15754558|NCT04821362|Device|Ultrasound group|In the ultrasound group, the nurses will insert the cannulas to the peripheral veins as horizontally and longitudinally with the linear probe.
15754559|NCT04821362|Device|Near Infrared Device Group|In the near infrared device group, the nurses will insert the cannulas to the peripheral veins with AccuVein AV 400.
15754605|NCT04821063|Drug|ITF2357 10 mg/mL|Dose: 300 mg (administered as 30 mL); Dosage form: suspension; Route of administration: oral
15754492|NCT04821934|Other|TR|"TR is a specific remote tele rehabilitation program on exercise activity managed by the physiotherapist (PT) at home, this is the experimental group. PT will explain the rehabilitation program at hospital discharge by the use of a brochure and videos. TR will include an early exercise re-conditioning program [aerobic exercise at the free body (with or without tools), cyclette and walking with a pedometer] comprising 20 sessions of 60 minutes/day, 6 out of 7 days to be performed at home, for one month after discharge. The sessions will be self-managed by the patients 4 times a week and an expert PT will remotely supervise 2 times a week through a dedicated platform. The program will be progressively incremental and divided into 4 different levels of intensity (0- 3).
~In addition to this specific rehabilitation program, the patients will be followed by a nurse tutor once a day for two weeks and once a week for a further two weeks in a program of Telesurveillance."
15754493|NCT04821934|Other|TSu|"The patients of this group will perform a usual Telesurveillance and will be considered as control group.
~All patients, at discharge from the hospital, will be provided with a finger pulse oximeter and a dedicated application (app) on their personal smartphone and will be advised on free physical activity to be performed at home. The nurse will check through scheduled calls (once a day for two weeks and once a week for a further two weeks) the patient's health condition, vital parameters and drugs administration. Patients will be able to contact the nurse at each time, in case of specific need, out of the scheduled call, 7/7 days.
~A follow up by phone will be planned by nurse tutor at 2 months from the end of the study."
15754494|NCT04821921|Other|No intervention|Care as usual
15754495|NCT04821882|Drug|Dextrose|10% dextrose: 2 mL of 50% dextrose in 10 mL normal saline and injected by 11 sub urothelial injections
15754496|NCT04821869|Drug|ProAir Digihaler|Monitor parameters transmitted from the Proair Digihaler to the Digihaler Dashboard, including peak inspiratory Flow, inspiratory volume and frequency of rescue use
15754497|NCT04821869|Device|Digihaler|Monitor parameters transmitted from the Proair Digihaler to the Digihaler Dashboard, including peak inspiratory Flow, inspiratory volume and frequency of rescue use
15754498|NCT04821856|Drug|Cannabidiol Oil|Cannabidiol (CBD) isolate 100mg/ml in MCT oil oral solution, manufactured by THC Pharma
15754499|NCT04821856|Drug|Placebo|MCT oil and flavoring solution, also manufactured by THC Pharma
15754500|NCT04821843|Drug|Platinum based chemotherapy|q1-3W according to physician's preference
15754501|NCT04821843|Drug|Paclitaxel based chemotherapy|q1-3W according to physician's preference
15754502|NCT04821843|Radiation|Radiotherpay|40-50Gy/1.8-2.2Gy/20-25f
15754503|NCT04821843|Procedure|Surgery|Radical esophagectomy
15754504|NCT04821843|Drug|Immunotherapy|Anti-PD-1/PD-L1 Antibody
15754505|NCT04821843|Drug|5-FU Analog based chemotherpay|W1-5 qW or d1-14, q3W according to physician's preference
15754506|NCT04821843|Drug|Nimotuzumab|200-400mg, d1,qW
15754507|NCT04821830|Drug|carbidopa/levodopa, as prescribed by treating physician|"There will be 4 measurement states:
~at baseline prior to chronic treatment initiation (OFF-No LDR); at baseline after a standard, acute oral dose (25/250 carbidopa/L-dopa), referenced in the protocol, but prescribed and provided by their prescribing physician as standard of care initial dosage (ON-No LDR); 2 months after initiation of chronic, stable L-dopa treatment (amounts and sequences as prescribed by treating physicians) but with no L-dopa for 10-12 hours prior to evaluation (Practical OFF- LDR); and after resuming subjects' usual physician-prescribed L-dopa dose (ON-LDR)."
15754508|NCT04821817|Drug|Normal saline|peribulbar anesthesia with 10 ml local anesthetic mixture composed of 4 ml of plain bupivacaine 0.5%, 4 ml of lidocaine 2% containing 50 IU, and 2 ml normal saline.
15754509|NCT04821817|Drug|Rocuronium|peribulbar anesthesia with 10 ml local anesthetic mixture composed of 4 ml of plain bupivacaine 0.5%, 4 ml of lidocaine 2% containing 50 IU, and 0.06 mg/kg of rocuronium in 2 ml normal saline.
15754510|NCT04821804|Drug|Hyaluronic Acid (HYADENT BG)|"the operator topically applied the HYADENT BG on the borders of the graft after stabilization.
~on the donor site and injection of HYADENT BG in collagen sponge that was placed over the site, then figure X sutures to close the area using (4-0 polyglycolic acid/ reverse cutting/ 12 mm) resorbable sutures"
15754511|NCT04821778|Radiation|Radiotherapy|50-66Gy/1.8-2.2Gy/25-30f
15754512|NCT04821778|Drug|Platinum based chemotherapy|q1-3W according to physician's preference
15754513|NCT04821778|Drug|Paclitaxel based chemotherapy|q1-3W according to physician's preference
15754514|NCT04821778|Drug|Immunotherapy|Anti-PD-1/PD-L1 Antibody
15754515|NCT04821778|Drug|5-FU Analog based chemotherapy|W1-5 qW or d1-14, q3W according to physician's preference
15754516|NCT04821778|Drug|Nimotuzumab|200-400mg, d1,qW
15754517|NCT04821765|Drug|PD-1 antibody|200mg, d1, q3W
15754518|NCT04821765|Radiation|Chemoradiation|50-60Gy (BED) was given (1.8-2 Gy or 3-4Gy once daily , 5 days a week
15754519|NCT04821765|Drug|Albumin-Bound Paclitaxel|150mg/m2, d1, q3W
15754520|NCT04821765|Drug|Cisplatin|75mg/m2, d1, q3W
15754521|NCT04821752|Behavioral|Avoidance Education|Dietary modification and lifestyle interventions
15754522|NCT04821739|Device|AGN1 LOEP SV Kit|The AGN1 LOEP SV Kit is intended for fixation of pathological fractures of the vertebral body using vertebral augmentation.
15754523|NCT04821726|Device|Drug eluting balloon (Vmoky)|Use Vmoky Drug Eluting Balloon to treat patients with symptomatic intracranial atherosclerosis stenosis
15754524|NCT04821700|Biological|Carotid Stenosis|To investigate if the concurrent presence of carotid stenosis has any effect on future outcomes of patients with ischemic stroke and atrial fibrillation
15754525|NCT04821687|Drug|Ongentys 50mg|Opicapone 50mg will be added to current and stable therapy of L-DOPA/DDCI
15754526|NCT04821687|Drug|Madopar Tab. 125 or Perkin Tab. 25-100mg|Madopar Tab. 125 or Perkin Tab. 25-100mg will be added to current and stable therapy of L-DOPA/DDCI
15754527|NCT04821674|Biological|DS-5670a|DS-5670a (10, 30, 60 or 100 µg) administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
15754528|NCT04821674|Biological|Placebo|Placebo administered as an intramuscular injection into the deltoid muscle of the upper arm; 2 injections total
15754529|NCT04821648|Drug|RJV001|Subcutaneous injection in the abdomen
15754530|NCT04821648|Drug|Placebo|The placebo formulation has the same shape, color, and qualitative composition as the RJV001 freeze dried powder, with the exception that RJV001 drug substance has been removed. For each cohort group, a placebo will be injected in a single site in the same area as the treatment.
15754531|NCT04821635|Device|Rower assisted by electrostimulation (FES-ROW)|"Pre-inclusion visit
~Inclusion visit
~Phase 1 Rower-FES with lower limbs (Month 0 to Month 3: M0-M3):
~Training on a rower with solicitation of the electrostimulated lower limbs only for a period of 3 months at the rate of 3 sessions of 30 minutes per week
~Interim assessment visit at Month 3 (M3)
~Phase 2 Rower-FES with lower limbs + upper limbs (Month 3 to Month 6: M0-M6):
~Training on with solicitation of the electrostimulated lower and upper limbs for a period of 3 months at the rate of 3 sessions of 30 minutes per week
~Final assessment visit at Month 6 (M6)
~End of clinical research visit, 3 months after the end of training (Month 9, M9)"
15754532|NCT04821622|Drug|talazoparib plus enzalutamide|experimental arm
15754533|NCT04821622|Drug|Placebo plus enzalutamide|Active comparator arm
15754534|NCT04821609|Behavioral|Resistance Training|The resistance training will be for arms and legs, self-loading type, and external weights.
15754535|NCT04821596|Other|biological collection|"Six 5 mL heparinized tubes, approximately 24 mL of blood will be collected as per standard practice. The 5 tubes collected from a given individual will be transported directly to the laboratory. In the laboratory, peripheral blood mononuclear cells (PBMC) will be prepared for the various analyses.
~However, in order to minimize the effect of agents other than CoA in MS patients, it is necessary that peripheral blood mononuclear cells are collected before treatment is given: for RR MS patients treated with first-line drugs (IFNβ, glatiramer acetate, teriflunomide and dimethyl fumarate, ...), RR MS patients treated with second-line drugs (natalizumab and fingolimod, ...) and RR MS patients treated with third-line drugs (alemtuzumab, ...)."
15754536|NCT04821583|Drug|Hydrocortisone|Hydrocortisone is orally administered.
15754537|NCT04821583|Drug|Placebo|Placebo is orally administered.
15754538|NCT04821570|Biological|COVID-19 Vaccine|Per recommended dosing schedule
15754539|NCT04821557|Dietary Supplement|Protease + Protein|Participant will consume a microbial protease supplement (31,875 Hemoglobin Unit Tyrosine base (HUT); protease activity) combined with a pea protein beverage (25 g pea protein; Roquette Nutralys® S85F)
15754540|NCT04821557|Dietary Supplement|Placebo + Protein|Participant will consume a placebo supplement (250 mg maltodextrin) combined with a pea protein beverage (25 g pea protein; Roquette Nutralys® S85F)
15754541|NCT04821544|Behavioral|Mindfulness-based intervention (with a focus on self-compassion; MBSC)|8-week MBSC intervention with a focus on increasing self-compassion
15754544|NCT04821505|Behavioral|Health Education|didactic classroom instruction on improving ones lifestyle through healthier diet, exercise and control of substance use.
15754545|NCT04821505|Behavioral|Transcendental Meditation|TM is described as simple technique practiced 20 minutes twice a day for deep rest and relaxation.
15754546|NCT04821492|Diagnostic Test|Dual-Energy X-ray Absorptiometry (DXA)|BMD expressed in absolute values as g/cm2 and T-scores
15754547|NCT04821479|Biological|Mesenchymal stem cells (MSC)|Intrathecal injections of autologous bone marrow derived mesenchymal stem cells
15754548|NCT04821466|Device|Virtual Reality Headset to provide a Virtual Reality Experience|Participants will utilise a Virtual Reality experience for distraction therapy via a Virtual reality headset. Participants will wear the Virtual reality headset to be immersed in a multimedia experience.
15754549|NCT04821453|Device|NAVA|NAVA mode of mechanical ventilation provide the trigger for a spontaneous breath from the diaphragmatic movement instead of diaphragm and allows the patient to control the dynamics of the breath generally set in CMV mode.
15754550|NCT04821453|Device|CMV|CMV mode of mechanical ventilation that provides a trigger for a spontaneous breath from the airway flow sensor with dynamics of the breath set as required by the mode
15754551|NCT04821440|Device|Water displacement volumetry|The examination will take place in several stages and by two operators. Initially, the patient will strip the limb concerned (leg or arm). Once the member is in the water column of the volumeter, a delimitation of the submerged area of the member will be carried out using a marking (black dermographic marker). Indeed, the level of acquisition in 3D is determined relative to the height of the water line marked on the skin with a black felt, this felt is usually used for venous mapping and is well tolerated The first operator will carry out two measurements one after the other with a change of water previously stabilized at room temperature.
15754552|NCT04821440|Device|Three dimension volumetry|The 3D volumetric acquisition is done with the sensor (CE marking) attached to the touch pad and does not require invasive or cutaneous contact with the patient (minimum acquisition distance of 40 cm). The operator triggers the acquisition via a button in an application installed on the tablet and physically turns around the patient to carry out the acquisition of the affected member. At the end of the acquisition, the operator presses a stop button and chooses whether or not to calculate the volume using another button depending on the quality of the acquisition.
15754553|NCT04821427|Behavioral|Brief mhealth intervention + mobile messaging to reduce sexual risk behavior and heavy drinking|The intervention is a brief, motivational video-conferencing intervention followed by four weeks of app-based, interactive mobile messages to reduce heavy episodic drinking and sexual risk behavior (condomless anal intercourse) among Black/African American and Hispanic/Latino men who have sex with men
15754554|NCT04821401|Dietary Supplement|Rejuvant|"Rejuvant tablets are sustained release tablets that release the active ingredients over 8-12 hours. Both product tablets are 0.500 round and 0.290 thick.
~AKG and AKG salts are grandfathered as GRAS compounds because these compounds were supplements prior to the Dietary Supplement Health and Education Act of 1994 (DSHEA). AKG and AKG salts are currently sold in the United States as supplements.
~The other components of the tablets are Vitamin A for the men's product and Vitamin D3 for the women's product. Vitamin A and Vitamin D are GRAS compounds per the FDA"
15754555|NCT04821401|Dietary Supplement|Placebo|Matching placebo tablets are composed of Cellulose, Carnauba wax and/or rice bran wax (to match the specs), stearic acid, magnesium stearate and silica.
15754603|NCT04821076|Other|Diet intervention - Energy balance|Energy balance is set to 50 kcal / kg fat-free mass
15754604|NCT04821063|Drug|ITF2357 10 mg/mL|Dose: 100 mg (administered as 10 mL); Dosage form: suspension; Route of administration: oral
15754560|NCT04821349|Device|Capsule endoscopy|"A consecutive series of patients recruited by 12 European centers based on the indication of OGIB will undergo capsule endoscopy examination.
~Capsule endoscopy will be performed in each site according to local rules and requirements, and the study protocol will concern only the post-procedure analysis on reading modalities for each patient."
15754561|NCT04821336|Other|Metabolites dosage|"On samples investigators will quantify cholesterol metabolite and dendrogenin A (DDA) and 6-oxo-cholestane-3β,5α-diol (ou OCDO) metabolites in malignant tissue sample on one hand, and in sane samples on other hand.
~The investigators will compare the rate of deregulation between sane and malignant ones."
15754562|NCT04821323|Drug|Indomethacin|Indomethacin capsules will be administered orally.
15754563|NCT04821323|Diagnostic Test|Lactulose-mannitol|Lactulose-mannitol solution will be administered orally.
15754566|NCT04821297|Other|Health Promotion and Education|Receive messages
15754567|NCT04821297|Other|Survey Administration|Complete survey
15754568|NCT04821297|Other|Interview|Participate in an interview
15754569|NCT04821284|Drug|Gemcitabine Hydrochloride|Given IV
15754570|NCT04821284|Drug|Nab-paclitaxel|Given IV
15754571|NCT04821284|Drug|Fluorouracil|Given IV
15754572|NCT04821284|Drug|Irinotecan Hydrochloride|Given IV
15754573|NCT04821284|Drug|Leucovorin Calcium|Given IV
15754574|NCT04821284|Drug|Oxaliplatin|Given IV
15754575|NCT04821284|Other|Perflubutane Microbubble|Oxaliplatin
15754576|NCT04821284|Procedure|Contrast-Enhanced Ultrasound|Undergo CEUS
15754577|NCT04821284|Other|Quality-of-Life Assessment|Ancillary studies
15754578|NCT04821271|Other|Placebo|Arm 1 and 2 Control Intervention
15754579|NCT04821271|Drug|TS-161 (50 - 100 mg)|Arm 1 and 2 Experimental Intervention
15754580|NCT04821258|Dietary Supplement|MICODIGEST 2.0 supplement|MICODIGEST is a nutraceutical which contains 9 different fungal extracts: Ganoderma lucidum, Agaricus blazei, Grifola frondosa, Hericium erinaceus, Cordyceps sinensis, Inonotus obliquus, Pleurotus ostreatus, Polyporus umbellatus y Lentinula edodes
15754581|NCT04821258|Dietary Supplement|Placebo supplement|Placebo
15754582|NCT04821232|Other|yoga|"Content of education;
~Breath Awareness Training (10 minutes)
~Students will be checked on a routine basis
~Asanas (20 minutes) I. Don't bend sideways in Mountain Pose ii. Warrior Pose iii. Bridge Pose iv. Happy Baby Pose
~v. Fixed Butterfly / Angel Pose vi. Wide sitting in Angel Pose vii. Cat Pose Tiger Breath viii. Cow-downward dog, ix. Plank x. Cobra c. Mudra and meditation (10 minutes) will be practiced."
15754583|NCT04821232|Other|Routin control|Students will be checked on a routine basis
15754584|NCT04821219|Other|Treatment prediction PDT platform|PDT will be generated and response to various chemotherapies and radiation will be investigated. Actionable targets will be identified and response to the target drug will be assessed and compared to the conventional treatment options.
15754585|NCT04821206|Drug|DMARDs|New Initiation of a DMARDs
15754586|NCT04821206|Drug|biologic DMARDs|New Initiation of a biologic DMARDs
15754587|NCT04821206|Drug|JAK Inhibitor|New Initiation of a JAK Inhibitor
15754588|NCT04821193|Drug|Skin antisepsis with 5% NaHCO3 water solution|In-vitro analysis of the solutions was done first. Then solutions were applied, and peripheric intravenous catheter was installed
15754589|NCT04821193|Drug|Skin antisepsis with 2% Chlorhexidine Gluconate solution|In-vitro analysis of the solutions was done first. Then solutions were applied, and peripheric intravenous catheter was installed
15754590|NCT04821180|Procedure|Three and four-part proximal humeral fractures' treatment|Open Reduction and Internal Fixation with angle stable plate PHILOS versus RSA (Reverse Shoulder Arthroplasty
15754591|NCT04821167|Procedure|laparoscopic orchiopexy for intra-canalicular testis|laparoscopic orchiolysis of abnormal fibrous attachments and then lap assisted transcrotal fixation of the testis in subdartos pouch for intra-canalicular testis
15754592|NCT04821154|Device|Persona Revision Knee System|Patients in this cohort will have been previously implanted with the Persona Revision Knee system in the described configuration per standard of care. The Persona Revision knee system is a total knee system that is widely available for use in the United States and is designed for use in primary and revision knee surgical interventions.
15754594|NCT04821128|Other|Radiologic and pathological review.|"We will analyse the pre operative scannographic and MRI (if available) images, and the post operative pathological analyses.
~The scanners will be reviewed by 2 well trained clinicians (one head and neck radiologist and one head and neck surgeon).
~Then we will analyse the correlation between the radiological and the pathological analysis."
15754595|NCT04821115|Device|Low intensity choc waves therapy (active applicator)|At each of the 4 sessions, 4000 shockwaves will be delivered at level 8 (EFD = 0.133 mJ/mm2), over a period of 15 to 20 minutes. The probe will be applied directly to the plaque, on the flaccid penis. The device will stop automatically after the 4000 shock waves.
15754596|NCT04821115|Device|Sham (sham applicator)|At each of the 4 sessions, a sham applicator will be used. The sham applicator has an internal foam pad that disperses the shockwave energy, but is not visible from the outside. The sham applicator will look, feel and sound the same as the active, but no measurable energy is emitted.
15754597|NCT04821102|Biological|JOINTSTEM|JOINTSTEM Autologous Adipose Tissue derived MSCs 1x10^8cells/(saline), 1 time injection under ultrasonic guided
15754598|NCT04821102|Drug|Saline|saline, 1 time injection under ultrasonic guided
15754599|NCT04821089|Biological|IPN10200|Several different doses will be administrated in a dose-escalation manner. One single injection will be injected locally into several sites across the glabellar region.
15754600|NCT04821089|Biological|IPN10200 Placebo|One single injection of study intervention will be injected locally into several sites across the glabellar region.
15754601|NCT04821076|Other|Diet intervention - caloric restriction|Energy restriction is set to 25 kcal / kg fat-free mass
15754602|NCT04821076|Other|Exercise intervention|Exercise will consist of supervised resistance training, interval training and moderate intensity cycling
15800879|NCT04444011|Drug|Amoxicillin|antibiotic
15754607|NCT04821063|Drug|Moxifloxacin Hydrochloride|Dose: 400 mg; Dosage form: tablet; Route of administration: oral
15754608|NCT04821063|Drug|Placebo|Dose: 30 mL; Dosage form: suspension; Route of administration: oral
15754609|NCT04821050|Device|Sacral nerve stimulation|"A senior acupuncture doctor will pierce filiform needles through the sacral foramen into the S3 and S4 sacral nerves. These sites correspond to the Zhongliao and Xialiao acupoints in Traditional Chinese Medicine.
~Electrodes will be clamped on the filiform needles and an electrical current of 0.5 mA will be delivered. The stimulation will last for 60 minutes every time, once a day for 2 weeks."
15754610|NCT04821050|Device|Sham stimulation|"Shallow acupuncture stimulation will be performed at sites 8-10cm away from the acupoints in Group 1.
~Electrodes will be clamped on the filiform needles and an electrical current of 0.5 mA will be delivered. The stimulation will last for 60 minutes every time, once a day for 2 weeks."
15754611|NCT04821037|Behavioral|ACT|Acceptance and Commitment Therapy
15754612|NCT04821024|Diagnostic Test|A self-administered questionnaire|A self-administered questionnaire will be used to screen Neck disability index, demographic information and ergonomic risk factors.
15754613|NCT04821011|Device|electronic stethoscope|Record of maternal heart sounds (heartbeats) with an electronic stethoscope during 10 minutes.
15754614|NCT04821011|Device|acoustic listening of mother's heartbeats|Each newborn included will have 20 minutes of an acoustic listening of their mother heartbeats previously recorded.
15754615|NCT04821011|Device|Recording of the newborn's heart rate|"Recording of the newborn's heart rate: one hour before the acoustic listening, during the acoustic listening and one hour after the acoustic listening .
~The variations of the autonomic nervous system will be analyzed.
~An coupled Heart rate variability recording (ECG signal obtained from a Philips® IntelliVue MX700 monitor) and NIPΣ index of comfort (MDMS® NIPΣ monitor) will be used."
15754616|NCT04820998|Other|Families|Families's interviews about their precarious situation of living and the consequences on their autistic child care
15754617|NCT04820998|Other|professionals|Interviews so as to know how the specifics of precarious situations are identified and taken into account by the professionals
15754618|NCT04820985|Other|Vaginal swab|Vaginal flora swab 3 months before stimulation, at oocyte puncture, embryo transfer and beta-human chorionic gonadotropin dosing
15754619|NCT04820985|Other|Blood test|Blood sample to measure plasma dose of progesterone
15754620|NCT04820972|Drug|Antiplatelet Agents|using antiplatelet agents in 3 days after surgery
15754623|NCT04820933|Drug|Doravirine 100 Mg|Doravirine 100 Mg orally dail
15754624|NCT04820920|Behavioral|LTP|LTP is a low-literacy, sustainable programme that will provide depressed mothers with valuable skills on parenting, improve mother-child relation and mental health self-care. This is a research-based activity that enhances postnatal mental health while simultaneously promoting attachment security through building parents' ability to monitor and be sensitive to their children's cues, and thereby, actively involves in their children's mental and physical development.
15754625|NCT04820920|Behavioral|CaCBT|CaCBT adopts 'here and now' problem-solving approach, which involves collaborating with families, active listening techniques, changing negative thinking, and depressive symptoms associated with postnatal depression and other forms of parenting distress.
15754626|NCT04820920|Behavioral|Placebo-effect|This is a form of psychoeducation involving basic discussions around mother-child relationships, childcare, child nursing related activities and general maternal discussions.
15754627|NCT04820907|Drug|HCP1904-1|Take it once daily for 8 weeks orally.
15754628|NCT04820907|Drug|RLD2001-1|Take it once daily for 8 weeks orally.
15754629|NCT04820894|Other|Electronic Medical Record|Medical records are reviewed
15754630|NCT04820894|Other|Survey Administration|Complete surveys
15754631|NCT04820868|Device|Multi-cancer early detection test|Blood collection and multi-cancer early detection test
15754632|NCT04820855|Behavioral|Treatment|This is the treatment program devised win conjunction with a pelvic floor physical therapist. It is a daily yoga series and mindfulness with a Smartphone app.
15754633|NCT04820855|Other|Usual Cares|This is standard treatment for Interstitial cystitis with your provider.
15754634|NCT04820842|Drug|TAK-994|TAK-994 tablets.
15754635|NCT04820842|Drug|Placebo|Placebo-matching tablets.
15754636|NCT04820829|Other|High RM, low NSS|Participants in this group will consume nine 3-oz-eq servings of RM per week and 2-oz-eq servings of NSS per week.
15754637|NCT04820829|Other|Moderate RM, Moderate NSS|Participants in this group will consume five 3-oz-eq servings of RM per week and 5-oz-eq servings of NSS per week.
15754638|NCT04820829|Other|Low RM, High NSS|Participants in this group will consume one 3-oz-eq serving of RM per week and 8-oz-eq servings of NSS per week.
15754639|NCT04820816|Other|pelvic tilt effect on balance, sensory integration and risk of fall|BIODEX balance system, Limits of stability test, Risk of Fall test, m-CTSIB test
15754640|NCT04820803|Other|ORAL INTERVENTION WITH CETYLPYRIDINIUM CHLORIDE|one mouthwash containing cetylpyridinium chloride (0.07%) for 60 seconds
15754641|NCT04820803|Other|PLACEBO|one mouthwash containing distilled (placebo) water for 60 seconds
15754642|NCT04820790|Other|Mobile applications|Monitoring of patients with home oxygen through a mobile application
15754643|NCT04820777|Other|perturbation training|external or internal postural perturbations. External perturbations occur by forces outside the patient' control (e.g., a push or pull from the physiotherapist). Internal perturbations caused when the patient is unable to control the centre of mass and the base of support relationship during voluntary movement; 'agility' tasks, such as kicking a soccer ball,
15754644|NCT04820777|Other|Conventional' balance training|Starting from a situated position, expand your left leg until it's corresponding to the floor. Try not to bolt your knee. At that point, gradually bring your foot down to the floor. Rehash with your correct leg, exchanging to and fro between legs for a s
15754645|NCT04820764|Device|CardioMech MVRS|CardioMech MVRS
15754646|NCT04820751|Drug|Cyproheptadine Hydrochloride 4 MG|Cyproheptadine associated to standard care
15754676|NCT04820452|Biological|Low dose IBI302|Low dose IBI302 intravitreal injection given as every other month after three loading monthly injection
15754647|NCT04820738|Other|Sensorimotor training exercises|Sensorimotor training exercises include wall slides , core exercises (Planks, leg raises, crunches, bridging) balance exercises (single leg side lift, leg lift with dumble, balance on stability ball) on unstable surface for 50-60 min (3 sets of 10 rep) of exercises and gait training (different patterns of walking
15754648|NCT04820738|Other|Without Sensorimotor training exercises|Cut back on high-fat foods. Drink plenty of water Use sugar and salt in moderation. Eat fruits and vegetables Get enough calcium Pump up your iron. Get enough fiber
15754649|NCT04820725|Diagnostic Test|Plantar pressure and gait|Gait analyses (cadence, stride length, swing phase duration, step duration and double stand duration) will be evaluated using Win-Track platform (MEDICAPTEURS Technology, France).
15754650|NCT04820699|Other|post isometric relaxation and muligan bent leg raise|6 week intervention
15754651|NCT04820699|Other|muligan bent leg raise|muligan bent leg raise
15754652|NCT04820686|Drug|VBR|VBR is an HBV core protein inhibitor. Participants will receive VBR 300 mg tablets orally once daily (QD).
15754653|NCT04820686|Drug|AB-729|AB-729 is a small interfering ribonucleic acid (siRNA) inhibitor of HBV. Participants will receive a 60-mg subcutaneous injection of AB-729 once every 8 weeks.
15754654|NCT04820686|Drug|SOC NrtI|Participants will receive their SOC NrtI (ETV, TDF or TAF) tablet orally as per approved package insert.
15754655|NCT04820673|Drug|Sarecycline|Clinicians will prescribe the sarecycline as per their own clinical judgment and standard practice.
15754656|NCT04820660|Other|Task orientated strengthening training|"Standing and reaching in different directions for objects located beyond arm's length to promote loading of the lower limbs and activation of lower limb muscles;
~Sit-to-stand from various chair heights to strengthen the lower limb extensor muscles;
~Stepping forward and backward onto blocks of various heights to strengthen the lower limb muscles;
~Stepping sideways onto blocks of various heights to strengthen the lower limb muscles;
~forward step-up onto blocks of various heights to strengthen the lower limb muscles;
~heel(s) raise and lower while maintaining in a standing posture to strengthen the plantar- flexor muscles.
~Each workstation was 5 min in duration for each exercise class. Each subject participated in a one-to-one therapy."
15754657|NCT04820660|Other|Balance training exercises|"Stepping forward, backward, and sideways on the exercise step;
~Stepping over blocks of various heights;
~Standing up from a chair, walking four steps forward, performing a bilateral stool touch and walking backwards to the chair;
~Standing up from a chair, walking four steps forward, turning to the right, stepping over the exercise step, turning to the right again and walking forwards to the chair (repeat the exercise circuit in opposite direction);
~From a sitting position on a 65-cm Swiss ball, performing a range of motion and balance exercises (forward and backward rolling of the
~Arms; bending the trunk forward and side to side);
~Performing double-legged stance for 10 s;
~Performing tandem stance for 10 s;
~Rising from a chair without the use of the arms;
~Walking forward and backward with a tandem walking pattern (toes of one foot touching the heel of the foot in front);
~Performing single- legged stance for 10 s."
15754659|NCT04820634|Other|Virtual Reality Job Interview Training|The treatment group (TX) will complete 7 sessions of VR-JIT (1 sessions per week for 7 weeks), designed to teach the skills & concepts of job interviews. Sessions are approximately 90 minutes long.
15754660|NCT04820634|Other|Wonderworks|The control group (CT) will complete 7 sessions of Wonderworks (1 session per week for 7 weeks) using skills in an office environment.
15754661|NCT04820621|Drug|Runcaciguat (BAY1101042)|Given as 1 x 15 mg modified release [MR] tablet
15754662|NCT04820608|Device|Cross-linking|Oxygen-boosted, epithelium-on, customized cross-linking. Highest UV-A application is focused on the apex of the cone. The cone area receives a moderate amount of UV-A, while healthy cornea is spared.
15754663|NCT04820595|Diagnostic Test|RASS|Richmond Agitation-Sedation Scale
15754664|NCT04820595|Diagnostic Test|CAM-ICU|Confusion Assessment Method for the ICU
15754665|NCT04820582|Other|Delphi Questionnaire|Evaluation of a list of PROMs and CROMs specific for endometriosis (previously selected from a litterature review) on a Likert scale of 1 to 9 for their relevance and feasibility
15754666|NCT04820569|Procedure|Resection and chemotherapy|
15754667|NCT04820543|Drug|injection of Botulinum type A|The participates were allocated to two different application methods: Simplified Method for the first injection and Individualized Method 8 months later. All the patients underwent twice injection with each methods with no change of the BTX-A(Botox, Allergan, Irvine, CA) and other injection details: Lyophilized 100 U of Botox was reconstituted in 2.5 mL of 0.9% sodium chloride solution. The injections were made with a 27-gauge insulin syringe. The treatment was an outpatient procedure and all injections were performed by one of the authors (X.G.). No anesthesia was given during the procedure.
15754669|NCT04820517|Other|Roy Adaptation Model Based Strengthening Program|"Applications included in the strengthening program sessions:
~Awareness study on social media addiction and its effects
~Awareness work on the correct and effective use of leisure time
~As a result of social media addiction, within the scope of Roy Adaptation Model, scenario sharing and problem solving process related to the problems arising in the fields of physical, group identity - self, role and interdependence
~Awareness work on recognizing and managing emotions
~Relaxation and Breathing Exercise in Emotion Management"
15754670|NCT04820504|Device|Augmented Infant Resuscitator (AIR)|Device provides visual feedback related to air leak, obstruction, hyperventilation, hypoventilation, and harsh breaths
15754671|NCT04820504|Device|AIR device without feedback|Device provides no visual feedback to clinician but records data on ventilation effectiveness
15754672|NCT04820491|Diagnostic Test|X-Ray|Shoulder x-rays as felt necessary for standard of care of diagnosis of shoulder dislocation and reduction
15754673|NCT04820491|Diagnostic Test|Ultrasound|Initial evaluation with ultrasound; may also evaluate nearby areas for concern of fracture. Order x- rays after ultrasound as seen fit for other injuries of diagnostic uncertainty.
15754674|NCT04820478|Dietary Supplement|Beta Hydroxybutyrate|see arm/group description
15754675|NCT04820465|Other|Non available due to cross-sectional study design|Non available since this study (survey) has a cross-sectional design
15800880|NCT04444011|Drug|Clarithromycin|antibiotic
15754677|NCT04820452|Biological|High dose IBI302|High dose IBI302 intravitreal injection given as every other month after three loading monthly injection
15754678|NCT04820452|Other|Aflibercept|Intraocular injection
15754679|NCT04820439|Drug|recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627)|A single intravenous infusion of HS627 420mg
15754680|NCT04820439|Drug|Perjeta ®|A single intravenous infusion of Perjeta ®420mg
15754681|NCT04820413|Other|Faecal microbiota transplantation|FMT by daily enema with donor faeces
15754682|NCT04820400|Other|Immersive VR Video|"The VR-360 video will be custom-made for the burn patient population. Through a review of current evidence for video scenarios/patients surveys, the study team will define and implement the key components appropriate for acute procedural pain such as type, duration and severity in this patient population. Next, patients will be asked about preferred pain relief elements (e.g. individual colours, geographical locations, sounds, etc.) that would help to design a video scenario. Finally, using a Likert pain scale, patients will be asked to rate each individual descriptor that exacerbates or alleviates pain. For instance, the colour red may be associated with 'flames', 'heat' and 'burns', and thus elevated pain, the colour blue may have the opposite effect, representing 'cooling' or 'cold'.
~Combined, this information will be used to create a VR-360 video geared towards alleviating acute procedural pain in patients with burn injuries undergoing dressing changes after skin graft."
15754683|NCT04820374|Procedure|pupil's light and pupil diameter|It is necessary to meet the requirement that the pupil's light reflection is slightly restored to the state of entering the room, and then the tube is extubated and the pupil diameter and the light reflection are restored to the state of entering the room, leaving the recovery room
15754684|NCT04820361|Drug|Cannabis sativa L., folium cum flore|Muscle Relaxation
15754685|NCT04820361|Drug|Placebo|Muscle Relaxation
15754686|NCT04820335|Behavioral|Structured External Memory Aid Treatment (SEMAT)|"During the 7 weeks of treatment, the interventionist will teach 3 categories of external memory aids (calendars, timers, notes) following an already-developed detailed treatment manual (described here briefly).
~Week 1: Introduction of External Memory Aid Treatment and Person-Centered Goal Setting. Weeks 2-7. In the next six weeks, three categories of external memory aids will be taught: calendars, timers, and notes. The focus of the first session will be how to use the strategies, and the second session will build awareness of when to use these strategies during everyday tasks. Within each category, three types of strategies will be taught to participants. Within each session, learning phases will follow training stages from compensatory learning theory: 1) acquisition phase, 2) application phase, and 3) an adaptation phase."
15754687|NCT04820322|Other|Fibersym|RS4-type resistant modified wheat starch
15754688|NCT04820322|Other|Control cookie|control cookie
15754690|NCT04820296|Other|Solution-Oriented Approach|First Session: Sharing thoughts about perception of childbirth, Creating positive goals, Informing about Birth, Birth Process, Basic Breathing Exercises and Deep Relaxation Exercises, Homework Second Session: Evaluating homework, Sharing thoughts about fear of childbirth, Miracle Question Technique, Evaluating with the Rating Questions Technique, Reframing the problem, Briefing on 'Body-Mind Connection at Birth, Fear-Tension-Pain Cycle, Hormones of Birth' and Breathing exercises, Homework Third session: Evaluating homework, Sharing thoughts about positive birth story, Information on symptoms indicating that the childbirth is approaching, pushing techniques, delivery positions, endorphin massage and breathing exercises (4/8 breaths, full breath when baby moves), Homework Fourth Session: Evaluating homework, Mother Baby Friendly Caesarean and Breathing exercises (3 candles a feather breath), Sharing feelings about the counseling process
15754691|NCT04820283|Behavioral|Care manager intervention (nurse)|In this intervention, a primary care nurse provides the participant with self-management support to manage stress-related problems. The participant meets with the nurse face-to-face for typically 2 to 6 sessions.
15754692|NCT04820283|Behavioral|Internet-based CBT|In this intervention, the participant receives treatment via an online treatment platform. The treatment is comprised of 12 modules, which entail information about stress management techniques including behavioral activation and exposure. The participant is guided by an online therapist who provides feedback on homework assignments.
15754693|NCT04820270|Other|Autologous T regulatory cells|Enriched autologous T regulatory cells are given back to the patient at the time of islet transplantation
15754694|NCT04820257|Behavioral|Home based exercise|Exercise at home and behavioural change to increase daily exercise
15754695|NCT04820244|Other|No intervention|No intervention
15754696|NCT04820231|Other|intra-articular PRP injection|
15754697|NCT04820218|Device|With Try-on glasses|Subjects will be asked to measure their visual acuity with their try-on glasses
15754698|NCT04820205|Drug|Intranasal dexmedetomidine and ketamine|Intranasal administration of dexmedetomidine (2mcg/kg) and ketamine (3mg/kg) to increase the success rate of adequate pediatric procedural sedation (pediatric sedation state scale = 1,2,3)
15754699|NCT04820205|Drug|Oral chloral hydrate|Oral chloral hydrate (50mg/kg) administration to induce adequate pediatric procedural sedation (pediatric sedation state scale = 1,2,3)
15754700|NCT04820192|Other|Craniosacral Therapy|The Upledger method of applying both specific and non-specific manual therapy of gentle, sustained, non-invasive stretch to soft tissues of fascia, meninges and osseous attachments. Fluid exchange is also believed to be a resulting result of CST. Treatment is applied to myofascial and osseous sites over the entire body, tending to specific and unique constellation of tissue restrictions and osseous compressions of soft tissue.
15754701|NCT04820179|Drug|Cabozantinib + Atezolizumab|All the subjects will be treated with the combination of cabozantinib and atezolizumab until disease progression, unacceptable toxicity or patient consent withdrawal (whichever occurs first).
15754733|NCT04819906|Drug|Estetrol 100 mg|Five estetrol monohydrate (E4) 20 mg tablets orally once
15754702|NCT04820166|Other|monitoring portal pressure gradient or hepatic venous pressure gradient|measuring portal pressure gradient or hepatic venous pressure gradient regularly
15754703|NCT04820153|Device|Physical Activity Monitoring Device|Participants will be provided a Fitbit Alta HR and wall charger. Each participant will be assigned a unique ID# at baseline and used to set-up the data acquisition. The Fitbit app will be set up on their smartphone to allow self-monitoring of activity. The Fitbit device includes both an accelerometer and heart rate monitor, capable of continuous measuring and storing data up to 5 days. Fitbit data will be passively downloaded through smartphone connection to Fitabase, a research friendly application and data management program. The Fitbit will be worn on the wrist every day during the course of the 16-week study, with instructions on self- monitoring, usage and maintenance. Participants will be monitored for Fitbit compliance by weekly phone calls; and monitoring of passively downloaded Fitbit data through Fitabase. Follow-up phone call at 3-months post-study will assess continued use of the Fitbit activity monitor.
15754704|NCT04820153|Behavioral|Lifestyle Redesign Coaching|Participants will receive individualized goal setting and a guide to increase exercise at baseline and at week four visit. The Occupational therapist (OT) will administer a well published approach for promoting PA called Lifestyle Redesign which addresses physical, psychosocial and environmental barriers to health and incorporate self-care strategies and goal setting. Coaching will be administered by a bilingual OT and in Spanish. Based on studies examining PA and brain health, the OT will guide the participant through a goal setting process for moderate to vigorous intensity of physical activity including a specific guide plan to achieve these goals of 10,000 steps per day and/or 150 minutes/week of moderate to vigorous activity. Participants will also receive weekly calls from the study coordinator (overseen by OT) to review PA and goal setting for each week over the course of the 16-week study.
15754705|NCT04820140|Procedure|Lymphatic drainage|Lymphatic drainage
15754707|NCT04820114|Other|Proprioceptive wrist exercises|Exercises for recognition of writs position and thumb force sense.
15754708|NCT04820114|Other|Wrist exercises|Passive and active exercises for improve range of motion in flexion, extension, ulnar and radial deviation
15754709|NCT04820101|Drug|Dexmedetomidine|administrating dexmedetomidine in order to evaluate the efficacy in achieving sedation for LISA procedure
15754710|NCT04820088|Other|Computer based role play trianing|Participants will train with a computer-based role-play simulation. They will interact with a lifelike video character on screen. They will interact with the character in one of four scenarios (i.e., patient intake, traditional needs, high-risk needs,and social and physical transition). They will receive real-time and after-action feedback in a safe, non-stressful environment. Their usage of the system will be monitored and transcripts will be collected.
15754711|NCT04820075|Behavioral|improvement of preoperative shower|Process about preoperative shower
15754712|NCT04820062|Other|Content Validity|For the validity of built, it is generally advisable to include a ratio of 100 participants for 30 questionnaire items. In order to have a suitable questionnaire, we will limit ourselves to 30 items which will be the size of our questionnaire. It was therefore planned to include 100 participants The selection of experts will be based on experience in this area, knowledge and availability. It will be a rescimant physician and an infectious disease doctor. Each expert will be invited in isolation to comment on the items in the questionnaire
15754715|NCT04820036|Diagnostic Test|Insulin Resistance|Insulin resistance: Fasting glucose and insulin will also be measured to calculate Homeostatic Model Assessment of Insulin Resistance (HOMA-IR), as a surrogate of IR
15754716|NCT04820036|Behavioral|Quality of Life Assessment|Quality of life will be assessed using the Chronic Liver Disease Questionnaire.
15754717|NCT04820036|Diagnostic Test|Liver Function Test|EUS-guided liver biopsy and portal pressure gradient measurement
15754718|NCT04820036|Diagnostic Test|Radiologic features of NASH|Controlled attenuation parameter (CAP) and liver stiffness scores assessed by transient elastography (TE)
15754719|NCT04820036|Diagnostic Test|Serologic features of NASH|Laboratory value assessment of alanine aminotransferase (ALT), liver chemistries, platelet counts, albumin and calculated NAFLD Fibrosis Score (NFS).
15754720|NCT04820023|Drug|BBT-176|BBT-176 given orally alone
15754721|NCT04820023|Drug|Cetuximab|intravenous cetuximab
15754722|NCT04820010|Drug|Topical Insulin|Patients were administered eyedrops enriched with insulin
15754723|NCT04819997|Other|Educational Intervention|Participate in videoconference session
15754724|NCT04819984|Device|TCM5 device (Radiometer) for PtC02 continuous measurement|Evaluation of PtC02 variation as a reflect of PaC02 during 30 minutes of weaning proof for mechanical ventilation (spontaneous ventilation on T-piece)
15754725|NCT04819971|Drug|Tirelizumab|Tirelizumab (intravenously, 200 mg on day 1 of every cycle for 4 preoperative and 12 postoperative cycles)
15754726|NCT04819971|Drug|Trastuzumab|Trastuzumab(intravenously, 8 mg/kg loading dose, then 6 mg/kg on days 1 of every cycle for 4 preoperative and 12 postoperative cycles)
15754727|NCT04819971|Drug|Docetaxel|docetaxel (intravenously, 50 mg/m2 on day 1 of every cycle for 3 preoperative cycles)
15754728|NCT04819971|Drug|S1|S1 (orally, 400mg/m2 BID on day 1~14 of every cycle for 3 preoperative and 3 postoperative cycles )
15754729|NCT04819971|Drug|Oxaliplatin|Oxaliplatin(intravenously, 100 mg /m2 on day 1 of every cycle for 3 preoperative cycles ;130mg /m2 on day 1 of every cycle for 3 postoperative cycles.
15754730|NCT04819945|Device|GATT-Patch|Use of GATT-Patch for minimal, mild or moderate bleeding sites in open liver surgery
15754731|NCT04819932|Drug|DWJ1451|DWC202008 DWC202009
15754732|NCT04819906|Drug|Estetrol 20 mg|One estetrol monohydrate (E4) 20 mg tablet plus four matching placebo tablets orally once
15754736|NCT04819893|Biological|Maternal blood sampling|5 mL sample of venous blood on arrival at the maternity ward in accordance with standard protocols
15754737|NCT04819893|Biological|Umbilical cord blood sampling|0.5mL sample from the umbilical cord after childbirth standard protocols
15754738|NCT04819893|Biological|Placenta sampling|Sampling of 3 cotyledons by cutting across the thickness of the placenta
15754739|NCT04819893|Other|Data collection|Newborn, Maternal and Premature Retinopathy Screening Data Collection
15754740|NCT04819867|Drug|Propolis|propolis is an extract derived from bee hives
15754741|NCT04819867|Drug|Gluma Desensitizer|Gluma is a desensitizer agent
15754742|NCT04819854|Drug|EP395|capsule for oral treatment
15754743|NCT04819854|Drug|Placebo|capsule for oral treatment
15754744|NCT04819841|Genetic|GPH101 Drug Product|GPH101 is administered via IV infusion following a myeloablative conditioning regimen
15754745|NCT04819828|Procedure|Extracorporeal shock wave lithotripsy|A single session of extracorporeal shock wave lithotripsy: the session will be finished upon reaching a maximum of 4,000 shocks or if a complete fragmentation of the kidney stone is observed.
15754746|NCT04819828|Drug|Diclofenac|Standard treatment for analgesia: oral diclofenac (75 mg/12 h) as needed.
15754747|NCT04819828|Drug|Tamsulosin|Oral tamsulosin (0.4 mg/day) for eight weeks.
15754748|NCT04819802|Other|Measurement of sublingual microcirculation|Sublingual microcirculation will be evaluated using a MicroScan (Microvision Medical, Amsterdam, the Netherlands) incident dark field imaging device. Perfusion measurements will be taken once a day during the first three days after inclusion (i.e. three measurement times). At each measurement time, five sequences of 20 secs will be recorded at five different sites. The video clips will be secondarily analyzed by a trained, blind investigator.
15754749|NCT04819802|Other|Plasma sampling|Additional volume during blood draw to assess plasma levels of the following endothelial markers: syndecan-1, angiopoietin-2, vascular endothelial growth factor-A (VEGF-A), thrombomodulin.
15754750|NCT04819789|Other|Fermotein™ dry powder porridge|At one out of four test days: Fermotein™ dry powder mixed with water and a few drops of food grade flavor concentrates, to obtain a porridge representing a 20g protein load.
15754751|NCT04819789|Other|Fermotein™ wet porridge|At one out of four test days: Fermotein™ wet mixed with water and a few drops of food grade flavor concentrates, to obtain a porridge representing a 20g protein load.
15754752|NCT04819789|Other|Fermotein™ modified wet porridge|At one out of four test days: Fermotein™ modified wet mixed with water and a few drops of food grade flavor concentrates, to obtain a porridge representing a 20g protein load.
15754753|NCT04819789|Other|Mycoprotein porridge (matching control)|At one out of four test days: Mycoprotein (Quorn) mixed with water and a few drops of food grade flavor concentrates, to obtain a porridge representing a 20g protein load.
15754754|NCT04819776|Drug|Iloperidone|Oral iloperidone
15754755|NCT04819776|Drug|Iloperidone Placebo|Oral placebo
15754756|NCT04819763|Other|Physical therapy|"Coordination training for lateral movement of the mandible (spatula exercise):
~A wooden spatula is loosely placed between the teeth of the upper and lower jaw; the head must be aligned with the body axis; the exercise should be performed in front of a mirror.
~The lower jaw moves to the left and back to the center with little contact to the spatula
~The lower jaw moves to the right and back to the center under contact with the spatula
~Training of the left lateral pterygoid muscle:
~The left palm is placed on the left temple region
~Right hand forms a fist and is placed on the tip of the right chin
~Both arms are aligned parallel to the surface of the floor
~The lower jaw is moved to the right against a moderate resistance of the fist = concentric muscle work
~With measured force of the fist, the lower jaw is brought back to the center = eccentric muscle work (Right lateral pterygoid muscle training with opposite hands.)"
15754757|NCT04819763|Other|Appliance therapy|"Upper and lower jaw impressions are registered by using an intraoral scanner. The arbitrary hinge axis position is determined using a face bow.
~The stabilization appliance with anterior canine guidance is manufactured in the Lexmann laboratory in Dresden.
~The stabilization appliance is incorporated by the dentist and the static and dynamic occlusion is checked. A tension-free fit of the appliance on the lower jaw is necessary. Additionally, equal contacts in the side teeth area and incisors guidance in the case of mandibular protrusion are checked visually and by using occlusion foil. During mandibular lateral movement only the canine guidance takes place and is also registered optically and by using occlusion foil.Interference contacts should be adjusted.
~The patient is instructed to wear the stabilization appliance while sleeping. The wearing rhythm is described as intermittent. (three nights - wearing the appliance, one night - not wearing the appliance)."
15754758|NCT04819750|Device|MusicCare® device|The device is a touch tablet with a headset that allows noise reduction. The patient can choose the music they prefer. The selected U-shaped sequence uses the principles of hypnoanalgesia to accompany the patient into a state of deep relaxation.
15754759|NCT04819750|Device|Headphones with noise reduction|Headphones with noise reduction without music
15754760|NCT04819737|Procedure|SC MRI|SC MRI (Averaged Magnetization Inversion Recovery Acquisitions (AMIRA), standard conventional SC MRI sequences, additional sequences for spinal cord MRI (sagittal-2D or 3D short tau inversion recovery, sagittal-2D or 3D phase-sensitive inversion recovery, 3D magnetization prepared 2 rapid acquisition gradient echoes (MPRAGE)). To evaluate the presences of ongoing inflammation (acute or chronic) in the SC of patients, 3D MPRAGE and 3D fluid-attenuated inversion recovery images after intravenous gadolinium (Gd) contrast administration (0.1 mmol per kg body weight) will be acquired.
15754761|NCT04819737|Other|patient questionnaire|12-item multiple sclerosis walking scale (MSWS-12) questionnaire: self-report measure of the impact of MS on the individual's walking ability
15754762|NCT04819724|Diagnostic Test|3D motion analysis|30° arm abduction in the scapular plane will be performed with and without a handheld weight of 1, 2, 3, and 4 kg. All movements will be done bilaterally. Electromyographic (EMG) data of arm and trunk muscles will be recorded using surface electrodes. Participants will be asked to perform full arm abduction with different rotations (internal, neutral and external rotation), flexion and internal-/external rotations movements (without additional handheld weight).
15754763|NCT04819724|Diagnostic Test|isometric shoulder strength by dynamometer|isometric shoulder strength for abduction and internal/external rotation will be assessed with a isometric shoulder strength for abduction and internal/external rotation will be assessed with a dynamometer
15754938|NCT04818216|Drug|Nicotinamide riboside|250 mg Nicotinamide riboside capsules
15754764|NCT04819724|Diagnostic Test|fluoroscopic images of each shoulder|fluoroscopic images (Multitom Rax, Siemens Healthineers, Erlangen, Germany) of each shoulder will be taken during the 30° arm abduction test with and without a handheld weight (0, 2, and 4kg)
15754765|NCT04819724|Diagnostic Test|Bilateral shoulder Magnetic Resonance Imaging (MRI)|MRI of both shoulders will be taken
15754766|NCT04819724|Other|data collection by health questionnaires|data collection by health questionnaires
15754767|NCT04819711|Behavioral|Thinking Healthy Programme|The Thinking Healthy Programme (THP) is an evidence-based intervention that is based on principles of cognitive behavioral therapy. It includes strategies that incorporate behavioral activation, active listening, collaboration with the family, guided discovery, and homework. The adapted THP consists of 5 integrated sessions. Session 1 introduces the programme and focuses on engagement of participants, introduction of THP, and breathing exercises. Session 2 focuses on psychoeducation and problem solving. Session 3 focuses on the mother's well-being and introduces activities such as physical exercises, good sleep practices and ensuring a balanced diet. Session 4 focuses on the mother's relationship with the unborn baby. Session 5 focuses on activating social support from family, friends and peers and provides closure of therapy.
15754768|NCT04819698|Other|Troponin I (cTnI ) monitoring|cTnI will be measured at baseline prior to surgery, as well as on 1h,12h, 24h and 72h after surgery for each patient in study B.
15754769|NCT04819685|Drug|KANG FU PEN|FU PEN: anti-radiation spray (liquid dressing) treatment which is a protective irrigation solution against rays
15754770|NCT04819672|Other|Low Intensity Training associated with Partial Blood Flow|16 treatment sessions in 8 weeks: warm-up, stretching of the lower limbs, strengthening of the quadriceps, hamstrings, sural triceps, abductors and adductors of the hip. The Partial blood flow restriction will be used during knee extension and squat exercises. During the exercises, a metronome will be used for the time under tension, 2 seconds for the eccentric and concentric phase.
15754771|NCT04819672|Other|Low Intensity Training associated with Partial Blood Flow-Sham|16 treatment sessions in 8 weeks: warm-up, stretching of the lower limbs, strengthening of the quadriceps, hamstrings, sural triceps, abductors and adductors of the hip. The Partial blood flow restriction will be used during knee extension and squat exercises. During the exercises, a metronome will be used for the time under tension, 2 seconds for the eccentric and concentric phase.
15754772|NCT04819659|Device|Pharyngeal packing|Placing gauze-like material in the nasal cavity to absorb blood or other fluids right after tracheal intubation.
15754773|NCT04819646|Dietary Supplement|Marine Lipid Oil Concentrate Formulation|Marine Lipid Oil Concentrate softgels
15754774|NCT04819646|Dietary Supplement|Dietary Supplement|Dietary Supplement capsules
15754775|NCT04819633|Other|Determination of serum sestrin levels|Serum sestrin levels will be determined using venous blood samples obtained from the subjects.
15754776|NCT04819620|Drug|PN-232|Active Drug
15754777|NCT04819620|Drug|Placebo|Matching Placebo
15754778|NCT04819607|Other|model of care|Multidisciplinary model of care for BMFS patients.
15754779|NCT04819594|Other|Elequil aromatabs ®|100% pure essential oils in a unique controlled delivery system for relaxation, comfort, and sleep. Scented tabs on a self-adhesive label will be placed on the nurses's uniform for 4 hours to provide aromatherapy for the clinical setting.
15754780|NCT04819581|Drug|SP-103|lidocaine topical system 5.4%
15754781|NCT04819581|Drug|ZTlido|lidocaine topical system 1.8%
15754784|NCT04819555|Genetic|Blood|a blood sample will be taken during hospitalisation for diagnostic confirmation or during the quarterly multidisciplinary consultations scheduled as part of the standard follow-up set up for these patients in the ALS centres of the FILSLAN network. If the genetic status is not yet known, this sample will be taken (1 tube of 7mL EDTA) and then sent within 24-48 hours at room temperature to one of the 3 participating molecular biology laboratories according to the criteria defined in the manual of samples being taken in the 3 laboratories.
15754787|NCT04819529|Behavioral|Early and Intensive Occupational Therapy|"Occupational therapists will implement the following activities:
~Polysensory stimulation: external stimulation for increasing the level of alertness. It will be implemented with SAS 1 one session each 48 h and SAS 2 one session each 24 h.
~Cognitive stimulation: bundle of exercises for activating mental functions, i.e: alertness, visual perception, memory, calculus, problem solving, praxis, language. Patients with SAS 3, 4 and 5. In SAS <2, 6> environmental orientation will be considered
~Basic activities of daily living (BADLs): promotion of independence that initially practice hygiene, personal grooming. Patients with SAS 3, 4 and 5
~Motor function Stimulation: exercises to keep the patient's upper extremities active and functional. Patients with SAS with 3,4 and 5. Patients with SAS 1 and 2 will use adaptations to prevent edema and bedsores on vulnerable body areas
~Education: daily visits by trained family members and health staff about the intervention process"
15754788|NCT04819516|Procedure|high-intensity focused ultrasound therapy|Patients will receive high-intensity focused ultrasound therapy in local site.
15754789|NCT04819516|Drug|Toripalimab|Toripalimab plus regorafenib
15754790|NCT04819503|Drug|Spinal anaesthesia (sub-study 1)|We will conduct two sub-studies on the same patient group. Sub-study 1 is an observational study where patients with phantom and/or residual limb pain after lower limb amputation will be given spinal anaesthesia with 1% Chloroprocaine in an open label manner to investigate whether the peripheral nervous system is a necessary driver of their pain.
15754791|NCT04819503|Device|Repetitive transcranial magnetic stimulation (sub-study 2)|After sub-study 1, the same patients will enter sub-study 2 where they are randomly assigned to receive either first active rTMS (10 days over 2 weeks), and then after a 9 week washout period, sham rTMS (10 days over 2 weeks), or they first receive sham rTMS, and then after 9 weeks of washout, active rTMS. Thus, patients undergo stimulation with deep rTMS in a double blinded randomised controlled trial with a 2 x 2 cross-over design, receiving both active and placebo stimulation
15754792|NCT04819477|Behavioral|Fact box|"All physicians surveyed receive a fact box with numerical information on the benefits and harms of chest CT as a screening method.
~In addition to the fact box, half of the participants will be randomly assigned to receive the same information in the form of a Cates plot."
15754890|NCT04818619|Diagnostic Test|flow cytometry test|Blood samples will be stained with TIGIT by flow cytometry test
15754793|NCT04819477|Behavioral|Cates plot|In addition to the fact box, half of the participants will be randomly assigned to receive the same information in the form of a Cates plot.
15754794|NCT04819464|Drug|Cenerimod|A single oral dose of 0.5 mg.
15754795|NCT04819451|Other|Magnesium-Rich Artificial Cerebrospinal Fluid (MACSF)|The Magnesium-Rich Artificial Cerebrospinal Fluid (MACSF) is composed of several qualified clinical intravenous injections according to a specific formula, which has similar physical and chemical properties to physiological CSF. MACSF will be freshly made and used. It will be prepared by trained professionals on a specific workbench and sent to the patient wards in a special container. Finally, it will be used in the CSF replacement. Aseptic principles should be enforced strictly during the whole procedures, including preparation, transportation and application.
15754796|NCT04819438|Drug|Riluzole 50 mg Oral Film|Before each administration, the subjects will drink 20 mL of still mineral water in order to wet their mouth. Afterwards, using gloves, the investigator or deputy will take the orodispersible film (32.0x22.0 mm) out of the provided pouch and place the product directly on the top surface (dorsal aspect) of the subjects' tongue.
15754797|NCT04819438|Drug|Rilutek 50Mg Tablet|One film-coated tablet will be swallowed (without chewing) with 150 mL of still mineral water.
15754798|NCT04819425|Device|Elastic Adhesive Strips|Securement of Endotracheal tube with Elastic Adhesive Strips
15754799|NCT04819425|Device|Lace in A Protective Sheath|Securement of Endotracheal tube with Lace in A Protective Sheath
15754800|NCT04819412|Biological|ROTAVAC®|ROTAVAC® with 5 minutes prior administration of 2.5 ml of buffer
15754801|NCT04819412|Biological|ROTAVAC 5C -F1|ROTAVAC 5C formulation BBIL-R2014-1
15754802|NCT04819412|Biological|ROTAVAC 5C -F2|ROTAVAC 5C formulation BBIL-R2014-2
15754803|NCT04819399|Drug|Catumaxomab|"Procedure: 6 weekly intravesical administration at each dose level; 3 sequential cohorts consisting of 3 patients (part I)
~cohort 50 µg
~cohort 70 µg
~cohort 100 µg
~Part II will be treated at recommended dose"
15754806|NCT04819373|Drug|BDB001|BDB001 is an immunotherapy agent.
15754807|NCT04819360|Drug|VESIcare 10Mg Tablet|"Vesicare® 10 mg per day for 12 weeks
~Vesicare 10mg 12 weeks"
15754808|NCT04819360|Drug|Botox 100 UNT Injection|1 injection of Botox® 100 UNT
15754809|NCT04819347|Drug|Albuvirtide|Long-Acting HIV-1 Fusion Inhibitor (chemically modified peptide targeting HIV-1 gp41)
15754810|NCT04819347|Drug|3BNC117|Recombinant, fully human mAb of the IgG1κ isotype that specifically binds to HIV-1 gp120.
15754811|NCT04819334|Other|Composition of Sports Drink|The composition of sport drinks will be manipulated to determine the effect of drink composition on the appearance of ingested water in body fluid.
15754812|NCT04819321|Device|CoolSculpting® System|A treatment is comprised of timed segments of cooling and heating; a vacuum treatment may include an optional massage
15754813|NCT04819282|Diagnostic Test|Senior Fitness Test|Senior Fitness Test, simple and easy to use, was used to evaluate physical performance.
15754814|NCT04819269|Drug|Tivanisiran sodium ophthalmic solution|1 drop in the affected eye(s) once daily
15754815|NCT04819269|Drug|Vehicle ophthalmic solution|1 drop in the affected eye(s) once daily
15754816|NCT04819256|Other|PACE-It mobile application|Care co-ordination platform
15754817|NCT04819243|Drug|Pabociclib, Endocrine, Talazoparib, Atezolizumab|"Palbociclib 125mg
~AI
~GnRH agonist
~Talazoparib
~Atezolizumab"
15754818|NCT04819243|Drug|Pabociclib, Endocrine, Talazoparib,|"Palbociclib 125mg
~AI
~GnRH agonist
~Talazoparib"
15754819|NCT04819230|Behavioral|Cognitive Bias Modification|A four-week computerized attentional and interpretive bias modification protocol in which participants complete both ATT and ITT tasks twice per week, totaling to eight experimental sessions (see experimental arm for more detail.)
15754820|NCT04819230|Behavioral|Cognitive Bias Control|A four-week computerized attentional and interpretive stimuli protocol in which participants complete both ATT-C and ITT-C tasks twice per week, totaling to eight control sessions (see placebo control arm for more detail.)
15754821|NCT04819217|Dietary Supplement|Active bamboo charcoal|During this 6 months' trial, eligible 120 patients with eGFR 15 < eGFR < 45 ml/min/1.73m2 and UACR > 100 mg/g will be enrolled and randomized into 4 groups. The patients in group 1 will receive CharXenPlus 4g (with ABC 2g) thrice daily + CharXprob 0.8 g once daily in the initial 3 months. Group 2 will receive CharXenPlus 4g thrice daily in the initial 3 months, and CharXprob 0.8 g once daily in the last 3 months. Group 3 will receive CharXprob 0.8 g once daily in the initial 3 months, and CharXenPlus 4g thrice daily in the last 3 months. Group 4 will only receive CharXprob 0.8 g once daily in the last 3 months.
15754822|NCT04819217|Dietary Supplement|Probiotics|Probiotics
15754823|NCT04819204|Drug|Cetrorelix Acetate|GnRH antagonist - subcutaneous injection. Day 1: 1-3 mg; Days 2-14: 0.25mg/daily.
15754824|NCT04819204|Drug|Testosterone gel|Testosterone gel - transdermal application of 5mg/day on Day 7-14 of GnRH antagonist
15754825|NCT04819191|Behavioral|SHARING Choices|SHARING Choices is a multicomponent communication intervention to proactively engage family members or friends and to support advance care planning in primary care
15754826|NCT04819165|Other|COVID-19|Impact of covid-19 on infections associated with health care devices.
15754827|NCT04819152|Behavioral|Tobacco cessation intervention|Already implemented in-person (including online meetings) tobacco cessation interventions in Sweden
15754828|NCT04819139|Other|Active Excersises|Active thumb exercises
15754829|NCT04819139|Other|Reeducation ADL|Reeducation in the activities daily life
15754830|NCT04819139|Other|Joint protection|Used of a thumb orthosis
15754831|NCT04819139|Other|Proprioception exercises|Specific proprioception exercises
15754939|NCT04818203|Biological|Clusters of Autologous Dermal Fibroblasts|Dose: 1 x 10^7 cells/1 mL/vial
15754832|NCT04819126|Other|Nintendo Wii Virtual Reality Application|The training group was trained with games from different categories such as balance and aerobic exercises with a Nintendo Wii virtual reality device 2 times a week for a period of 6 weeks, with 1 session lasting for 30 minutes.
15754833|NCT04819113|Biological|Nimenrix|MenACWY-TT vaccine
15754836|NCT04819087|Behavioral|Questionnaires and Rehabilitation Programs|Questionnaires and Rehabilitation Programs
15754837|NCT04819074|Procedure|Microsurgery|Microsurgery for unruptured intracranial aneurysm
15754838|NCT04819061|Other|tDCS Active|This group will undergo the motor training and active tDCS. Will be performed 12 sessions in three sessions per week for 30 minutes. Participants will undergo an electroencephalogram before starting the clinical trial. The duration between this baseline EEG and entry into the clinical trial that will assess the effectiveness of tDCS will be two weeks. We will determine the clinical improvement labels used for machine learning classification based on data obtained during the clinical trial (baseline and post-treatment assessments), according to procedures conducted in similar studies.
15754839|NCT04819061|Other|tDCS sham|"This group will undergo the motor training and tDCS sham. Will be performed 12 sessions in three sessions per week for 30 minutes. Participants will undergo an electroencephalogram before starting the clinical trial. The duration between this baseline EEG and entry into the clinical trial that will assess the effectiveness of tDCS will be two weeks.
~We will determine the clinical improvement labels used for machine learning classification based on data obtained during the clinical trial (baseline and post-treatment assessments), according to procedures conducted in similar studies."
15754840|NCT04819048|Device|Low-Level Laser Therapy+acupuncture|"The experimental group will be firstly irradiated by the GaAlAs infrared laser (CDHC,Denlase 980/7 Diode Laser Therapy System,China), with an output of 500 mW, emitting radiation wavelength of 980 nm, spot size 0.2cm2 ,15J/point, in a continuous mode .The therapeutic LLLT application is achieved through direct contact of the probe on the skin.
~The needles using are disposable, sterile, individually packed, and made of stainless steel (Hua Tuo; Suzhou Medical Supplies Factory Co, Ltd,Suzhou, China), in sizes 0.25 mm ×40 mm.Asepsis of the skin will be performed with cotton wool and 75% alcohol."
15754841|NCT04819048|Device|Low-Level Laser Therapy|The experimental group will be firstly irradiated by the GaAlAs infrared laser (CDHC,Denlase 980/7 Diode Laser Therapy System,China), with an output of 500 mW, emitting radiation wavelength of 980 nm, spot size 0.2cm2 ,15J/point, in a continuous mode .The therapeutic LLLT application is achieved through direct contact of the probe on the skin.
15754842|NCT04819035|Diagnostic Test|CBC-DIFF Monocyte Volume Width Distribution (MDW)|MDW measurement will be used to detect sepsis. Results will not be used to manage patients.
15754843|NCT04819022|Device|Acute and post-acute|These programs will cover patients suffering from acute or post-acute musculoskeletal conditions including, but not limited to, shoulder pain (tendinitis/impingement/bursitis), neck pain, low back pain, knee or hip pain/osteoarthritis, which significantly impact their quality of life, to the extent they seek specialised care in direct relation to these disorders.
15754844|NCT04819022|Device|Chronic|These programs will cover patients suffering from chronic musculoskeletal conditions including, but not limited to, shoulder pain (tendinitis/impingement/bursitis), neck pain, low back pain, knee or hip pain/osteoarthritis, which significantly impact their quality of life, to the extent they seek specialised care in direct relation to these disorders.
15754845|NCT04819022|Device|Post-surgical|These programs will cover patients submitted to surgery for a given musculoskeletal condition, including, but not limited to, shoulder tendon repair, shoulder replacement, spinal surgery, hip or knee replacement, meniscal repair, knee ligament reconstruction, undergoing physical rehabilitation programs after surgery.
15754846|NCT04819009|Other|the Enhanced Transtheoretical Model Intervention (ETMI)|"ETMI consists of a physical and functional examination, a discussion about the role of physical activity matched to the patient stage of change, and guided through motivational interviewing techniques, exposure to fast walking, and goal setting. The patient receives a postcard outlining the main messages about physical activity and four simple stretches.
~The ETMI method consists of four parts:
~Creating a therapeutic alliance (communication skills and reassurance)
~Clear messages to the patient: Mandatory 3 sentences: (1. physical activity is the only thing that will help your back pain over time. 2. It's easy to reduce your pain now - but the important thing is to prevent the next episode, 3. Your body must be strong and flexible.)
~Exposure to brisk walking (brisk walking in the corridor, hand by hand with the therapist) and graded activity.
~Postcard with reminder messages on how to self manage the back."
15754847|NCT04818996|Behavioral|Mediterranean Diet|"While calculating the energy of the Mediterranean diet applied to the individuals participating in the study, Mifflin-St. Jeor equation is used. The macronutrient composition of the Mediterranean diet was calculated as 36-40% fat, 40-45% carbohydrate and 15-20% protein. This diet is enriched with natural foods (fruits, vegetables, legumes, whole grain foods, fish, olive oil and oilseeds such as walnuts and almonds).
~In addition, anthropometric measurements and body composition analysis of the participants were performed both at the beginning and at the end of the study, and some biochemical parameters (IL-6, TNF-α, CRP, MDA, TAS, TOS and routine blood parameters) were evaluated."
15754848|NCT04818970|Device|Narrow Band ultraviolet B-Band Light|Daily doses of NB-UVB for 8 consecutive days.
15754849|NCT04818970|Device|non Narrow Band ultraviolet B-Band Light|Daily doses of non-NB-UVB for 8 consecutive days.
15754850|NCT04818957|Dietary Supplement|Oral Thin Film (OTF) Cholecalciferol (Vitamin D3)|Study participants will receive vitamin D OTF weekly for a maximum of 12 weeks. The dose may be increased or decreased based on the dosing schema.
15754851|NCT04818944|Drug|Tirofiban Hydrochloride|Tirofiban Hydrochloride will be dosed for 24 hours post MT via continuous IV
15754852|NCT04818944|Drug|Placebo|Saline will be dosed for 24 hours post MT via continuous IV
15754853|NCT04818931|Drug|Cefazolin Injection|cefazolin 2 g or clindamycin 900 mg in case of penicillin allergy
15754854|NCT04818918|Device|Absolute coronary flow measurement|Absolute coronary flow will be measured.
15754855|NCT04818918|Device|Microvascular resistance measurement|Microvascular resistance will be measured.
15754856|NCT04818918|Other|Cardiac MRI|Cardiac MRI will be performed to evaluate myocardial viability.
15754936|NCT04818229|Drug|Placebo-matched Moxifloxacin|Placebo-matched Moxifloxacin tablets oral administration.
15754857|NCT04818905|Dietary Supplement|Helichrysum italicum infusion|Active beverage or control beverage consumption after overnight fasting and calorimetry measurement on a single subject. After seven days washout period follows the consumption of the alternate beverage and measurements.
15754858|NCT04818905|Other|Hot water|Active beverage or control beverage consumption after overnight fasting and calorimetry measurement on a single subject. After seven days washout period follows the consumption of the alternate beverage and measurements.
15754859|NCT04818892|Diagnostic Test|Serological Assay for SARS-CoV-2|LabCorp's Cov2Quant IgG™ assay which uses immunoassay that uses electrochemiluminescent technology (ECL) for quantitative determination of anti-receptor binding domain (RBD) IgG antibodies specific to SARS-CoV-2.
15754860|NCT04818879|Other|Vojta|"The subject will be placed on a stretcher with the torso uncovered. Once the adhesive electrodes have been placed in the different recording areas on the anterior part of the trunk, a recording of the activity at rest will begin, two minutes of stimulation (digital pressure), one minute of rest, two minutes of stimulation in the contralateral side and, finally, one minute of rest.
~The therapy consists of the application of a stimulating pressure in the pectoral area in the pattern of the locomotion complex of reflex rolling in its first phase. For this, the subject will be placed in a supine position aligned with respect to the axial axis, with the arms along the body, the lower extremities in extension, and the head extended with a rotation of approximately 30º towards one side of the stimulation. The manual stimulation pressure will be exerted in the space between the 6th-7th or the 7th-8th rib under the mammillary line, with a force of about 2 kg."
15754861|NCT04818879|Other|Control|"The subject will be placed on a stretcher with the torso uncovered. Once the adhesive electrodes have been placed in the different recording areas on the anterior part of the trunk, a recording of the activity at rest will begin, two minutes of stimulation (digital pressure), one minute of rest, two minutes of stimulation in the contralateral side and, finally, one minute of rest.
~The control group will receive an application in an area with low receptor density located on the thigh, with a force of about 2 kg."
15754862|NCT04818866|Diagnostic Test|SuPAR, C-reactive protein, Ferritin, D-Dimer, Procalcitonin, Interleukin-6, Lactate Dehydrogenase|Biomarkers of inflammation
15754863|NCT04818853|Other|Observation to monitor patients for these infections|We will be receiving discarded specimens weekly. From these we are going to identify these various potential infections.
15754864|NCT04818840|Device|Resurfaced Patella|JOURNEY II CR Total Knee System was used for Total Knee replacement
15754865|NCT04818840|Procedure|Un-resurfaced Patella|JOURNEY II CR Total Knee System was used for Total Knee replacement
15754866|NCT04818814|Behavioral|Mindfulness Meditation App|Listening to audio-guided meditation sessions using a mobile app.
15754867|NCT04818814|Behavioral|Engagement and Distraction App|Listening to engaging and distracting videos of interest to the participant using a mobile app.
15754868|NCT04818801|Biological|Recombinant two-component COVID-19 vaccine (CHO cell)|The spike (S) protein is the main surface antigen of SARS-CoV-2, mediates entry of SARS CoV-2 into cells expressing the angiotensin-converting enzyme 2 (ACE2). The RBD interacts with ACE2 and can generate potent neutralizing anti-RBD antibodies.
15754869|NCT04818801|Other|Placebo|Normal saline (0.9% sodium chloride solution),
15754870|NCT04818788|Drug|Biological Drug|we will give biological drugs to indicated ulcerative colitis patients and we will investigate the predictive ability of fecal calprotectin and hematological indices to histological remission
15754871|NCT04818775|Device|HemaClear|HemaClear Model A
15754872|NCT04818775|Device|Pneumatic Tourniquet|Pneumatic Tourniquet
15754873|NCT04818749|Drug|Saline|Saline (placebo) will be administered intravenously before block performance and after the induction of general anaesthesia.
15754874|NCT04818749|Drug|Dexamethasone 12 mg|Dexamethasone 12 mg will be administered intravenously before block performance and saline (placebo) will be administered intravenously after the induction of general anaesthesia.
15754875|NCT04818749|Drug|Dexamethasone 12 mg + dexmedetomidine 1 mcg/kg|Dexamethasone 12 mg will be administered intravenously before block performance and dexmedetomidine 1 mcg/kg will be administered intravenously after the induction of general anaesthesia.
15754876|NCT04818736|Biological|COVID-19 Vaccination|Dose 1: 0.5 mL at Day 0 Dose 2: 0.5 mL at Day 28
15754877|NCT04818736|Other|Usual care|Participants can receive the COVID-19 whenever they are eligible according to local provincial guidelines.
15754878|NCT04818723|Drug|Montelukast|We wanted to know the role of leukotriene receptor antagonist (LTRA) montelukast in preventing relapses in idiopathic childhood nephrotic syndrome (NS)
15754879|NCT04818710|Procedure|skin incision with a scalpel|"A Pfannenstiel skin incision was done through the subcutaneous tissue, rectus sheath and dissected from rectus muscle until peritoneum was visualized.
~group 1 (skin incision with a scalpel)"
15754880|NCT04818710|Procedure|skin incision with diathermy|"A Pfannenstiel skin incision was done through the subcutaneous tissue, rectus sheath and dissected from rectus muscle until peritoneum was visualized.
~group 2 (skin incision with diathermy)"
15754881|NCT04818684|Other|questionnaire|a questionnaire consisting of a list of support practices
15754882|NCT04818671|Biological|efgartigimod PH20 SC|Subcutaneous injection with efgartigimod PH20 SC
15754883|NCT04818658|Other|Assessment of the stainless steel crown using the Hall Technique and Compomer Restoration on primary molars|Intra-oral clinical examination is performed and restorations are evaluated by the practitioner. Periapical radiography is taken according to national guidelines.
15754884|NCT04818645|Device|Confirm Rx Insertable Cardiac Monitor|Subjects will be subcutaneously implanted with an Abbott Confirm Rx ICM with the device implant procedure per standard of care and current labelling. Data related to subjects' arrhythmias, via the Merlin.net Patient CareNetwork will be transmitted on a monthly basis to the treating physician and subsequently to the study coordination and database center (CDC) at the University of Rochester. Data on the frequency/types of symptomatic (patient triggered) versus ICM detected (asymptomatic) arrhythmic events will be collected and adjudicated. Clinical data on medication, device interventions, cardiovascular events will be collected at follow-up visits.
15754885|NCT04818645|Other|Conventional Management and monitoring|Subjects randomized to the conventional management arm of the trial will undergo arrhythmia monitoring based on clinical indications and per standard available modalities including periodic electrocardiograms (ECG), Holter and/or event monitoring.
15754886|NCT04818632|Drug|AZD9833|Part A: AZD9833 monotherapy dose escalation.
15754891|NCT04818606|Other|Mindfulness Oriented Recovery Enhancement|Participants randomized to the intervention group will undergo an eight-week mindfulness training program as instructed by MORE for the Treatment of Chronic Pain manual. This eight-week intervention will consist of weekly synchronous video conferencing sessions during which participants will be asked to follow along with a guided meditation read by the study lead and to engage in reflection and discussion exercises with other study participants. Participants will also be asked to complete weekly activities and daily mindfulness practices outside of weekly synchronous meetings.
15754892|NCT04818593|Device|ZyMot Multi Sperm Separation Device (850 ul)|850 uL of untreated semen will be directly deposited into the inlet port of the ZyMotTM Multi device, followed by placement of 750 uL culture medium in the outlet port and throughout the upper collection chamber. The device will then be incubated in a humidified 37C CO2 incubator for 30 minutes. During incubation, the healthiest and most motile sperm will swim through the microporous filter and into the upper collection chamber, where they will be recovered via the outlet port. 500 uL of the sperm sample will be removed and placed in a separate tube for analysis and insemination.
15754893|NCT04818593|Other|Density Gradient Centrifugation|Density gradient centrifugation will be performed using a one-layer preparation of 90% Isolate in 15 mL conical tubes. Semen will be layered over 1 mL of gradient and then centrifuged for 15 min at 300xg. The supernatant will be removed and discarded. The sperm pellet will be washed by mixing with Multipurpose Handling Medium Complete and centrifuging the sample for 5 min at 400xg. After the wash, the supernatant is removed and discarded and the pellet is re-suspended in culture medium, assessed for sperm parameters, and held at room temperature until insemination.
15754894|NCT04818580|Procedure|Progressive Tension Sutures|In each patient, one side of the chest will receive progressive tension sutures inside the mastectomy pocket, from pectoral fascia to underside of mastectomy flap. 2-0 Vicryl about 15-20 sutures per chest. Both sides will receive bilateral drains (standard of care)
15754895|NCT04818541|Device|PPCI|Closure of the femoral access site with PerQseal device at the end of the PPCI index procedure and removal of the Impella pump.
15754896|NCT04818541|Device|Cardiogenic shock|Closure of the femoral access site with PerQseal device after removal of the Impella pump.
15754897|NCT04818528|Other|Constraint Induced Movement Therapy and Routine Physical Therapy|"Intensive, graded practice of the paretic upper limb to enhance task-specific use of the affected limb. Constraint or forced use therapy, with the non-paretic upper limb contained in a mitt to promote the use of the impaired limb during 90% of the total hours awake. Adherence enhancing behavioral methods designed to transfer the gains obtained in the clinical setting or the laboratory to patients' real-world environment (ie, a transfer package).
~As part of routine physical therapy patients received intervention that worked on aerobic capacity, muscle strengthening exercise, walking ability, postural and balance disorders and improving hand arm function. Three stages were used in each session: (i) warm-up phase: passive mobilization of major joints and lower limb muscle strengthening; (ii) active phase (both standing and sitting): motor control exercises for upper and lower limbs, and (iii) cool down phase (in seating position): respiratory exercises and mobilization."
15754898|NCT04818528|Other|Routine Physical Therapy|As part of routine physical therapy patients received intervention that worked on aerobic capacity, muscle strengthening exercise, walking ability, postural and balance disorders and improving hand arm function. Three stages were used in each session: (i) warm-up phase: passive mobilization of major joints and lower limb muscle strengthening; (ii) active phase (both standing and sitting): motor control exercises for upper and lower limbs, and (iii) cool down phase (in seating position): respiratory exercises and mobilization.
15754899|NCT04818515|Drug|Atogepant|Oral; Tablet
15754900|NCT04818515|Drug|Ubrogepant|Oral; Tablet
15754901|NCT04818502|Device|Tendyne™ Mitral Valve System|Transcatheter mitral valve implantation (TMVI) using the Tendyne™ Mitral Valve System , in which a bioprosthetic valve is implanted within the native mitral valve.
15754902|NCT04818489|Drug|Colchicine 0.5 MG|colchicine 0.5 mg (2 tablets: 1 mg) twice per day as a loading dose, followed by one tablet 0.5 twice per day for three weeks in addition to the standard protocol
15754903|NCT04818489|Other|the standard protocol only|the local standard protocol for COVID19
15754904|NCT04818476|Procedure|diagnostic endoscopic resection|diagnostic endoscopic resection
15754905|NCT04818450|Drug|Gabapentin|Gabapentin 100-300 mg is given to the intervention group
15754906|NCT04818437|Other|BALANCE TRAINING|Trunk, head, and upper limbs rotation from kneeling. 2- Upper limbs flexion and extension with simultaneous head movement from kneeling. 3-Pelvic bridging followed by raising one lower limb and extending knee. 4-Lifting opposite upper and lower limbs from Quadruped position. 6-Heel and toe raises, alternate rising of he right and left feet above the floor, and tandem standing. 7-Weight shifting forward. backward, sideward, and diagonally with eyes opened and eyes closed
15754907|NCT04818437|Other|CORE STABILITY EXERCISES|"Abdominal bracing while lying in supine position.
~Abdominal bracing with heel slide while lying in supine position.
~Abdominal bracing with Leg lifts while lying in supine position.
~Abdominal bracing with bridging while lying in supine position.
~Abdominal bracing while Standing.-Abdominal bracing while walking.
~7-Quadra pod arm lifts with bracings while Quadra pod position. 8-Quadra pod alternate arm and leg lifts with bracing while Quadra pod position. 9-Side plank with knee flexion while side lying. 10-Side plank with knee extension while side lying"
15754908|NCT04818424|Device|Soft exosuit|A soft exosuit is a textile-based wearable robot that is worn on the paretic ankle. Soft exosuits provide assistive torques through retraction of Bowden cables that connect distally to anchor points on front and back of the ankle, assisting with dorsiflexion during swing for foot clearance, and plantarflexion during late stance to assist with propulsion, respectively. Exosuit assistance is provided synchronously based on the wearer's gait, as detected by integrated inertial measurement units.
15754909|NCT04818424|Behavioral|Gait training without exosuits|Control intervention will implement gait training without exosuits. Other elements of intervention are similarly structured as with REAL, with the only exception of using exosuits.
15754932|NCT04818242|Diagnostic Test|POC BG + Blinded CGM|Point of Care (POC) testing before meals and bedtime (standard of care). For the control group, participants will also get a CGM sensor (blinded CGM). CGM alarms are turned off, however if the POC is found to be between <80 mg/dl by POC, 15 grams of carbohydrates will be given as a preventive measurement for hypoglycemia (standard of care).
15754933|NCT04818229|Drug|CBP-307|CBP-307 capsules oral administration.
15755029|NCT04817423|Other|No intervention|No intervention
15754910|NCT04818411|Other|Routine physical therapy treatment with the Stabilization exercises|The program was based on specific training of the transversely oriented abdominal muscles with coactivation of the lumbar multifidus at the lumbosacral region, training of the gluteus maximus, the latissimus dorsi, the oblique abdominal muscles, the erector spinae, the quadratus lumborum, and the hip adductors and abductors. Initially, we focused on the specific contraction of the transversely oriented abdominal muscles. After approximately 2 weeks, loading was progressively increased throughout the intervention period. The women were required to exercise for 30 to 60 minutes, 3 days a week, for 3-4 weeks.
15754911|NCT04818411|Other|Routine physical therapy treatment + High-velocity thrust manipulation|: For high-velocity thrust technique, a modified Chicago technique was used. For this procedure, the lumbopelvic region was targeted. The side to be treated was chosen, based on the subject's report of her most symptomatic side. The physical therapist, performed passively side bend the subject toward the painful side, rotate the upper body in the direction opposite to the side bending, and then deliver a quick posterior and inferior thrust at a grade V including a small-amplitude/high-velocity therapeutic movement. A maximum of 2 attempts per side was permitted if no pop was heard following the first attempt. If the subject showed improvement of 50% or less after the first treatment, the intervention was categorized as a failure, the examination and intervention were repeated, and the subjects were asked to return 2 to 4 days later. If the subject showed greater than 50% improvement, the intervention was categorized as a success, and study participation was concluded.
15754912|NCT04818398|Drug|DS-6016a|DS-6016a will be administered as a single subcutaneous injection into the upper arm, upper part of the thigh, or abdominal wall
15754913|NCT04818398|Drug|Placebo|Placebo will be administered as a single subcutaneous injection into the upper arm, upper part of the thigh, or abdominal wall
15754914|NCT04818372|Drug|CM313-Dose escalation|Subjects will receive a single dose of CM313 followed by a 3-week period for DLT observation. After that subjects will have 6 infusions at weekly intervals.
15754915|NCT04818372|Drug|CM313|Subjects will have 8 infusions at weekly intervals, and then 8 infusions at bi-weekly intervals. After that CM313 will be given every 4 weeks until disease progression or unacceptable toxicity.
15754916|NCT04818372|Drug|Dexamethasone|dexamethasone 40 mg/day at day 1,8,15,22 at 28 days cycle
15754917|NCT04818372|Drug|Lenalidomide|25 mg/day lenalidomide 21 of 28 days cycle
15754918|NCT04818359|Behavioral|MoviS Training|Patients will undergo a supervised exercise program consisting of 3 months of aerobic exercise training (2 d/week of directly supervised exercise and 1 d/week of remotely supervised exercise) with a progressive increase in exercise intensity (40-70% of heart rate reserve) and duration (20-60 min).
15754921|NCT04818333|Drug|SHR-A1811|Phase 1 Drug: SHR-A1811 There are four pre-defined dose regimens . Subjects will be enrolled with an initial dose Phase 2 Drug: SHR-A1811 Doses will be determined from Phase 1
15754922|NCT04818320|Drug|Favipiravir|Day 1: 1800mg BD, day 2-5: 800mg BD
15754923|NCT04818307|Other|Macquarie Injury Management group|Group A was treated by MIMG (soft tissue mobilization) with base line treatment (Hot pack for 10 mint, Quadriceps Isometrics, Stretching). For the application of technique subject lies supine with extended knee, therapist places both hands on the knee and gently apply soft tissue release. This procedure was applied for 2 to 3 minutes.
15754924|NCT04818307|Other|Mulligan Mobilization with Movement|Group B was treated by Mulligan Mobilization with movement with base line treatment (Hot Pack for 10 mints, Quadriceps Isometrics, Stretching). For the application of technique subject lies supine with 30 degree knee flexion, therapist places right hand below the knee and left hand above the knee. Apply the lateral glide on the joint. This procedure was applied for 3 times.
15754925|NCT04818294|Device|Pain treatment by electrostatic charge to the whole body|"Study Type is Observational as participants in the study receive therapeutic interventions in the therapy cabin as part of routine medical care and a researcher studies the effect of the intervention.
~The study includes all persons who are already receiving therapy in the mentioned facilities, no external, specifically selected persons, but existing patients suffering from chronic pain who meet the specified conditions.
~The therapy aims to alleviate chronic pain by applying an electrostatic charge of 50'000 Volt to the whole body in the special, electrically insulated cabin. The treatment is done upon the instructions of a physician. It is done with the patient standing up in the treatment cabin. The person is charged and discharged several times over the course of 2x 4 minutes. The charge can be felt on the skin and it can be seen through bristling of the hairs on the body. This treatment is repeated once a week."
15754926|NCT04818281|Biological|SARS-CoV-2 VLP Vaccine|VLP adjuvanted vaccine
15754927|NCT04818281|Biological|Placebo|0.9% NaCl
15754928|NCT04818268|Behavioral|Adaptation|Sensorimotor adaptation in speech
15754929|NCT04818268|Other|cTBS|continuous theta-burst stimulation
15754930|NCT04818255|Behavioral|PET Biomarker Disclosure|Participants receive information about whether they currently have elevated or not-elevated amyloid and/or tau based on recent PET imaging conducted as part of an affiliated research study (no additional imaging is required for this project). Participants meet with a licensed clinical neuropsychologist to discuss their biomarker status, the meaning of this information, and potential next steps to consider based of their status. Participants receive written summaries of this information, as well as resources as deemed necessary or as requested.
15754931|NCT04818242|Device|Dexcom G6 CGM with CTS|CGM sensor will be placed after consent. Glucose values obtained from the CGM sensor will be sent to the CGM transmitter by Bluetooth technology and DEXCOM Share2 software application to a smart phone that serves as an intermediate-transmitting (routing) device. Glucose values from the smart phone will be transmitted wirelessly to a table computer (I-Pad) using the DEXCOM Follow application. Information on the CGM will activate an alarm in case of hypoglycemia or hyperglycemia events. Hypoglycemia alarm will be set to < 85 mg/dl (for prevention for low blood glucose levels). Nursing staff will be instructed to provide 15 grams of carbohydrates in response to a hypoglycemia alarm.The hyperglycemia alarm will be set at 300 mg/dl. If this occurs, the nursing staff will assess clinical status and perform a POC glucose testing to confirm glucose values. If BG > 300 mg/dl, nursing staff will communicate the high glucose value to the primary care team.
15754934|NCT04818229|Drug|Placebo-matched CBP-307|Placebo-matched CBP-307 capsules oral administration.
15754935|NCT04818229|Drug|Moxifloxacin (Avelox)|Moxifloxacin tablets oral administration。
15754940|NCT04818203|Other|Placebo|The injection solution without clusters of autologous dermal fibroblasts
15754941|NCT04818190|Procedure|Sensory neurotization|The donor nerve is a cutaneous nerve that is identified with the most inferior lateral perforator vessels. The nerve is then dissected for neurotization and divided at the level of the fascia where it is a pure sensory nerve. The recipient intercostal nerve is usually easily identified in the third intercostal space during the dissection of the internal mammary artery and vein. The anterior branch of the third intercostal nerve can usually be found at the junction of the inferior portion of the third rib and the sternum, approximately 80% of the time. The nerve is dissected and transected medially. It is then mobilized to give it the longest length possible in preparation for neurotization. Neurotization is performed by coapting the donor nerve to the third anterior intercostal nerve directly with a 9-0 nylon suture in standard fashion.
15754942|NCT04818177|Drug|Institutional standard intravenous immune globulin treatment|No treatments will be prospectively assigned. Subjects will receive their standard intravenous immune globulin doses. We will measure body composition and identify the relationship between body composition and intravenous immune globulin disposition.
15754943|NCT04818151|Drug|Warfarin|Warfarin treatment for VTE
15754944|NCT04818151|Drug|Apixaban|Apixaban treatment for VTE
15754945|NCT04818138|Device|Narrowband UVB phototherapy|Narrowband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
15754946|NCT04818138|Device|Broadband UVB phototherapy|Broadband UVB phototherapy (full body) administered three times weekly according to individual clinical protocols.
15754947|NCT04818125|Other|Patients with breast cancer (stage I, II III or IV)|"Blood samples will be collected at different times:
~at Baseline for all patients with breast cancer: before initiation of treatment (i.e. before initiation of planned treatment for stage I to III patients and before any new line of treatment for stage IV patients);
~at the time of disease progression (or at 12 months in absence of progression) for patients with metastatic breast cancer (stage IV)
~For each patient a tumor sample from the initial diagnosis of the disease (i.e. primary tumor +/- biopsy of a metastasis) will be collected (archived tumor block) for the study."
15754948|NCT04818112|Behavioral|ATVV|A 15-minute behavioral intervention that mothers administer once daily to their infant for 3 months providing Auditory, Tactile, Visual, and Vestibular (ATVV) stimulation. Multisensory stimuli are presented in gradual progression. Mother-infant engagement is attempted throughout ATVV so that mothers learn to identify, interpret and adapt to their infants cues. ATVV can be given without eye to eye gaze making it appropriate for newborns. ATVV is offered contingent on infant cues to promote self-regulation and withdrawn if any persistent disengagement cues. Mothers are taught how to adapt ATVV as their infant grows. Fidelity to the intervention is checked with weekly phone calls and monthly study visits. Mothers also receive a daily text from REDCap to document an intervention frequency log.
15754949|NCT04818112|Behavioral|Attention control|Mothers in the Attention Control group receive a similar amount of daily texts, weekly phone call and in-person study visit attention as mothers in the ATVV group, but with distinctly different content. Over the first 3 postnatal months, mothers learn safe infant-care that includes content on diapers, infant clothing, blankets, infant care including bathing, sleep positions, sleep habits, holding the baby, safety of infant equipment, breastfeeding, formula, and age appropriate toys.
15754950|NCT04818099|Drug|Vortioxetine 10 mg|Vortioxetine will be used with a dosage of 10mg once a day, for 2 months.
15754951|NCT04818099|Other|Placebo|Placebo will be used with a dosage of one tablet once a day for 2 months.
15754952|NCT04818086|Drug|Lemborexant|5 mg of lemborexant, and 10 mg of lemborexant, all subjects will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film.
15754953|NCT04818086|Drug|Placebo|Placebo tablet all subjects will receive 16 mg/4 mg of buprenorphine-naloxone sublingually as a film.
15754954|NCT04818073|Device|New FINGER|NEW FINGER exoskeleton is a robotic device that can provide assistance and resistance to thumb and finger movement
15754955|NCT04818073|Device|Proprioception Extension Trainer|Proprioception Extension Trainer device is a robotic device that can provide target specific finger proprioception training.
15754956|NCT04818060|Other|Clinical Assessments|A neurological evaluation will be administered to all participants at baseline, 1 year and 2 year follow-up visits. Motor exams and premorbid IQ assessments will be video-recorded for rater reliability assessments conducted randomly throughout the research project.
15754957|NCT04818060|Diagnostic Test|MRI Scan|At baseline and 2 year follow-up all participants will undergo a 60-minute 3T MRI scanning session which will consist of measures of the volume of brain tissue and cerebral spinal fluid, as well as connections in the brain measuring water pathways and pictures of the brain active and at rest.
15754958|NCT04818060|Diagnostic Test|Lumber Puncture (LP)|Participants will be asked to complete a LP at both onsite study visits (baseline and 2 year follow-up). Blood collection following the procedure will consist of about 80mL and will be stored at a repository for biomarker analysis.
15754959|NCT04818047|Behavioral|VID-KIDS Intervention Program|"Investigators created VID-KIDS for mothers with PPD to improve sensitivity and positive responsiveness towards their infants. Video-feedback has the advantage of being visually concrete yet distant because the action and the feedback are not concurrent; this helps mothers maintain an element of objectivity that may minimize guilty feelings associated with potential perceived lack of parenting skills. Videofeedback interventionists are trained by investigators with manualized modules. Including: Introduction to Video-feedback; NCAST Keys to Caregiving Program; Infant Engagement and Disengagement Cues; Video-feedback Intervention Protocol; Overview of Behaviours of Interest; Case Studies; and Examples of Strengths-Based Feedback. VID-KIDS intervention follows an 8-step protocol."
15754960|NCT04818034|Drug|Dapagliflozin|Dapagliflozin is to lower blood sugar levels in adults with type 2 diabetes.
15754961|NCT04818021|Behavioral|Adaptation|Sensorimotor adaptation in speech
15754962|NCT04818021|Behavioral|Facial Skin Stretch|Facial skin stretch
15754963|NCT04818008|Other|Otago Exercise Program|A Home-based Exercise Program to improve strength and balance and prevent falls.
15755030|NCT04817410|Drug|Emergency Department Initiated Oral Naltrexone|Emergency Department Initiated Oral Naltrexone
15755191|NCT04816162|Drug|ketofol|prepared in a ratio of (1:4) respectively), where 1ml of ketamine will be added to 20 ml of propofol in a syringe pump
15755192|NCT04816162|Drug|dexmedetomidine|2 ml (200 µg) of dexmedetomidine added to 0.9% normal saline in a syringe pump
15754964|NCT04817995|Behavioral|FOREST|Intervention is going to take the form of an internet-based stress recovery intervention consisting of six modules. The themes include introduction, psychological detachment, distancing, mastery, control, and keeping the change alive. These themes were chosen after considering topics that might be the most useful for healthcare staff experiencing high levels of stress. Each module consists of psychoeducation and exercise parts. Psychologist provide individual feedback on completed exercises as well as can be reached on demand.
15754965|NCT04817982|Drug|Perineural dexamethasone|Dexamethasone 4mg will be added perineurally to an ulnar nerve block with bupivacaine.
15754966|NCT04817982|Drug|Lidocaine|Lidocaine 40 mg will be added perineurally to an ulnar nerve block with bupivacaine.
15754967|NCT04817982|Drug|Placebo|Saline will be added perineurally to an ulnar nerve block with bupivacaine.
15754968|NCT04817982|Drug|Systemic dexamethasone|Dexamethasone will be added perineurally to an ulnar nerve block with bupivacaine, some will be reabsorbed and distributed systemically. Thereby, the investigators control for the systemic effects of adding perineural dexamethasone to an ulnar nerve block.
15754969|NCT04817969|Device|Zimmer Biomet Persona Ti-Nidium Total Knee System|Primary Knee Total Arthroplasty
15754970|NCT04817956|Drug|Atezolizumab|drugs used outside indication, based on biomarker
15754971|NCT04817943|Other|Non applicable|When the patient enters the operating room, oxygen saturation, blood pressure, and electrocardiogram are monitored, and general anesthesia is induced using 1-2 mg/kg of 1% propofol. 0.8 mg/kg of rocuronium, a neuromuscular blocker, is injected intravenously, and a human endotracheal tube is intubated. A thermometer is attached to the inside of the double-layered endotracheal tube cuff, which measures the temperature in the trachea. After the endotracheal intubation is performed, the esophageal thermometer is inserted, and from this point, the temperature measured by the esophageal thermometer and the thermometer of the endotracheal tube are recorded. The temperature immediately after insertion of the esophageal thermometer is set as Tbaseline, and the temperature of the esophagus and trachea, the temperature of the operating room, and the temperature of breathing circuit with heated wire humidifier are recorded every 5 minutes from thereafter until the end of the operation.
15754972|NCT04817930|Device|Polyetheretherketone patient specific implant|a customized peek patient specific implant is place to augment the chin
15754973|NCT04817930|Device|Computer guided advancement genioplasty|advancement genioplasty using patient specific cutting and positioning surgical stents
15754974|NCT04817917|Biological|Japanese Encephalitis Vaccine (Vero Cell), Inactivated;|The investigators recruit 6 years old children who have been vaccinated by 2-3 doses of JE vaccines with different immunization strategies. For participants from Group 1 and Group 2 who haven't completed the JE immunization schedules, a booster dose of JEV-I will be administered at 6 years old.
15754975|NCT04817917|Other|No prospective interventions|The investigators recruit 6 years old children who have been vaccinated by 2-3 doses of JE vaccines with different immunization strategies. Participants from Group 3-5 have completed the JE immunization schedules with JEV-I or/and JEV-L. No prospective intervention will be given.
15754976|NCT04817904|Drug|Rosuvastatin 10mg|The statin-treated arm will receive Rosuvastatin tablets 10 mg/day starting from the point of cisplatin initiation through the entire duration of therapy
15754977|NCT04817891|Device|HD-tDCS|Participants will receive HD-tDCS at up to 4 mA per channel for 20 minutes for 10 sessions. Dose determined through individualized computational models.
15754978|NCT04817878|Combination Product|Developmental assessment|Physical development assessment (head circumference, length, weight), Neurodevelopment assessment at 36 to 40 weeks of correction (GMS assessment, NBNA assessment), neurodevelopment assessment at 18 months, 24 months, and 36 months (ASQ scale, Language assessment, Wei-style scale), audiovisual screening, etc.
15754979|NCT04817865|Diagnostic Test|Multiplex-PCR with Pooled Antibiotic Susceptibility Testing (M-PCR/P-AST)|M-PCR/P-AST is a dual assessment test that detects pathogenic DNA commonly associated with urinary tract infections and identifies their genotypic and phenotypic antibiotic resistance.
15754980|NCT04817865|Diagnostic Test|Urine Culture|A traditional clinical UTI evaluation consisting of non-molecular standard urine culture (SUC) and sensitivity testing methods.
15754981|NCT04817852|Other|CBCT data of c-shaped canal in mandibular second molar.|Detection of variation in root canal morphology in mandibular second molar by using CBCT.
15754982|NCT04817839|Behavioral|3-week post-operative activity restriction|Participants will be given postoperative instructions which include refraining from lifting anything over 20 pounds, avoiding strenuous exercise, running, or performing high-impact aerobic activities for 3-weeks post operation.
15754983|NCT04817839|Behavioral|6-week post-operative activity restriction|Participants will be given postoperative instructions which include refraining from lifting anything over 20 pounds, avoiding strenuous exercise, running, or performing high-impact aerobic activities for 6-weeks post operation.
15754984|NCT04817826|Drug|Durvalumab|durvalumab 1500 mg Q4W for 3 cycles (day 1, 29 and 57).
15754985|NCT04817826|Drug|Tremelimumab|tremelimumab 300 mg single administration (day 1)
15754986|NCT04817800|Drug|140/100 μg Azelastine hydrochloride/Beclomethasone Dipropionate)|It will be nasaly administered
15754987|NCT04817787|Drug|Metformin|Taken if randomized to exercise + metformin group (either low or high intensity exercise)
15754988|NCT04817787|Behavioral|Exercise|Either low intensity or high intensity exercise
15754989|NCT04817787|Drug|Placebo|Will be randomized to receive either the placebo or metformin drug
15754990|NCT04817774|Biological|TX200-TR101|TX200-TR101 is an autologous gene therapy medicinal product composed of Treg cells (CD4+/CD45RA+/CD25+/CD127low/neg) that have been ex vivo expanded and transduced with a lentiviral vector encoding for a CAR to recognize HLA-A*02. Treatment will be given via an IV infusion at a pre-defined timepoint several weeks after transplant. Three, single ascending dose cohorts of TX200-TR101 are planned and an additional expansion cohort.
15755068|NCT04817163|Behavioral|Web-based cognitive-behavioral therapy for insomnia (CBT-I)|Each week, the patients first have to read written information on the website (www.insomnet.ca), and then watch a video capsule (duration between 5 and 20 min each). Patients complete their daily sleep diary electronically on the website and the content is interactive. It includes the sending of automated emails to remind participants to complete the treatment tasks and encourage adherence, provision of tailored feedback (e.g., texts, charts) based on the information that they provide in their sleep diary, as well as quizzes with automated correction to reinforce patients' understanding of the content.
15754991|NCT04817761|Drug|Calaspargase pegol (S95015)|"Part 1: S95015 will be administered at dose of 2000 U/m2, 1500 U/m2 or 1000 U/m2 (dose level based on age and BMI) via a 2-hour intravenous infusion at Day 4 (or 5, or 6) of the induction phase, Days 15 and 43 of the consolidation phase, Day 22 of the interim maintenance phase and Days 4 (or 5, or 6) and 43 of the delayed intensification phase. S95015 starting doses for age and BMI groups will be confirmed.
~Patients will receive premedication prior to calaspargase pegol administration (acetaminophen, histamine-1 blocker, and corticosteroids to prevent hypersensitivity reaction) and other backbone chemotherapy agents based on the CALGB 10403 protocol treatment regimen.
~Part 2: S95015 will be administered at doses as confirmed in part 1."
15754992|NCT04817735|Procedure|TAVI|TAVI sizing with dedicated algorithm
15754993|NCT04817722|Drug|Intravenous Solution|Intraoperative hydration
15754994|NCT04817709|Other|Educational Intervention|Review workbook
15754995|NCT04817709|Other|Usual Care|Receive educational materials
15754996|NCT04817709|Other|Media Intervention|Watch video
15754997|NCT04817709|Other|Medical Chart Review|Review of medical records
15754998|NCT04817709|Other|Questionnaire Administration|Complete questionnaires
15754999|NCT04817696|Other|Patients without chronic pain symptoms|Verbal score < 3 at 3 months
15755000|NCT04817696|Other|Patients with chronic pain symptoms|Verbal score ≥ 3 at 3 months
15755001|NCT04817670|Drug|VIT-2763|"Subjects will receive 1 capsule of 30 mg VIT-2763 in the morning and 1 capsule of placebo in the evening, for 8 weeks.
~Capsules will be taken orally."
15755002|NCT04817670|Drug|Placebo|"Subjects will receive 1 capsule of placebo in the morning and 1 capsule of placebo in the evening for 8 weeks.
~Capsules will be taken orally."
15755003|NCT04817670|Drug|VIT-2763|"Subjects will receive 1 capsule of 30 mg VIT-2763 in the morning and 1 capsule of placebo in the evening for 4 weeks followed by 1 capsule of 30 mg VIT-2763 in the morning and 1 capsule of 30mg VIT-2763 in the evening for 4 weeks.
~Capsules will be taken orally."
15755004|NCT04817670|Drug|VIT-2763|"Subjects will receive 1 capsule of 30 mg VIT-2763 in the morning and 1 capsule of 30 mg VIT-2763 in the evening for 8 weeks.
~Capsules will be taken orally."
15755005|NCT04817670|Drug|VIT-2763|"Subjects will receive 1 capsule of 30 mg VIT-2763 in the morning and 1 capsule of 30 mg VIT-2763 in the evening for 4 weeks followed by 1 capsule of 60 mg VIT-2763 in the morning and 1 capsule of 60 mg VIT-2763 in the evening for 4 weeks.
~Capsules will be taken orally."
15755006|NCT04817657|Biological|Ad26.COV2.S|Participants will be administered 0.5 milliliter suspension of Ad26.COV2.S 1*10^11 virus particles per milliliter (vp/ml) as intramuscular injection.
15755007|NCT04817644|Drug|Oral semaglutide|Oral semaglutide once daily for a total of 10 days
15755008|NCT04817631|Other|tuboovarian abscess|Evaluating the surgical and medical management of tuboovarian abscess
15755011|NCT04817605|Other|Therapeutic Exercise|Exercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations.To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.
15755012|NCT04817592|Procedure|Corneal lenticule extraction for advanced refractive correction (CLEAR)|Routinely conducted procedure for correction of Myopia
15755013|NCT04817579|Device|Digital photography combined with eLABor_aid shade analyzing software|ELABor_aid is a new approach to objective shade communication and shade reproduction in dentistry, based on numeric quantification obtained from standardized RGB (red-green-blue) images, and the formulation of a patient personal shade recipe using trichromatic subtractive color mixing laws, thus abandoning the use of visual assessment and shade guides entirely. This approach is currently enjoying increasing popularity for its ease of use, reliability as well as for its practically oriented features like its imaging ability or the digital try-in.
15755014|NCT04817579|Device|Spectrophotometer|Spectrophotometric measurement methods employing computer calculations, based on color science and theories, allow quantitative evaluation which is objective and appears to be more accurate.
15755015|NCT04817579|Device|Conventional visual shade matching|Visual shade matching is the most common method, in which a color standard from a commercially available dental shade guide is compared to and matched with the target tooth.
15755016|NCT04817566|Device|Anodal tDCS|Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (2 mA).
15755017|NCT04817566|Device|Sham tDCS|Sham transcranial direct current stimulation (tDCS), 9 sessions with 30 sec stimulation each (2 mA) to ensure blinding of participants.
15755018|NCT04817566|Behavioral|Intensive cognitive training|Intensive cognitive training of a letter memory updating task, 9 sessions for approximately 20 min
15755019|NCT04817553|Other|exposure to COVID19|Observational study of IgG4 patients with pancreatobiliary involvement who were diagnosed with COVID19
15755020|NCT04817540|Drug|Herzuma|8mg/kg IVF loading dose at first cycle -> 6mg/kg IVF at 2,3,4th cycle of each 21 day cycle
15755021|NCT04817527|Drug|Edaravone Dexborneol|Intravenous injections of edaravone dexborneol (37.5mg in 0·9% NaCl) BID for 7-14days.
15755022|NCT04817514|Other|Shoulder rehabilitation exercises and aerobic exercises|"SRG group: the group will only perform mobility and strengthening exercises involving the shoulder complex.
~ARG group: The ARG group will perform the shoulder rehabilitation protocol presented above combined with the aerobic exercise program that will last 20 minutes per session at 40% of the reserve heart rate (HRC), progressing up to 40 minutes with a maximum of 60% of the HRC in the last two weeks, according to the recommendations for patients with type 2 DM proposed in the American College of Sports Medicine Guidelines."
15755023|NCT04817501|Other|Taking 5 ml of venous blood at different time intervals|
15755024|NCT04817501|Other|Taking 5 ml EDTA-stabilized ascitic fluid sampled during laparoscopy if any|
15755025|NCT04817488|Other|Prehospital emergency ultrasound with tele-supervision|Prehospital emergency ultrasound with tele-supervision in patients with acute dyspnoea
15755026|NCT04817488|Other|Prehospital emergency ultrasound without tele-supervision|Prehospital emergency ultrasound without tele-supervision in patients with acute dyspnoea
15755027|NCT04817475|Other|Point-of-care ultrasound with tele-supervision|Point-of-care ultrasound of patients with a out-of-hospital cardiac arrest will be performed with tele-supervision.
15755028|NCT04817436|Other|physical activity program (APA)|adapted physical activity program (APA)
15755031|NCT04817384|Other|Graston technique|For Graston practice, children will be asked to sit with a support forward. Vaseline will be used as an intermediate during the application. Instruments made of stainless steel material of a type suitable for the body structures and sizes of the children will be preferred. Larger instruments will be used for larger areas and smaller for smaller regions and fibrocytic areas. The frequency of the plastering and friction movements will be applied in 60 repetitions per minute. While the graston technique is applied to individuals; Superficial muscles in the entire dorsal region will be included in the treatment. These muscles, respectively, the levator scapula, trapezius, and erroctor spina muscles were selected. The treatment time takes approximately 20-25 minutes depending on the area being treated. The instant effects of the people will be looked at.
15755032|NCT04817384|Other|Classical Massage|In the neck massage application, the patient should be prepared, and the clothes in the upper back and neck area should be removed. The position of the patient will be in a sitting position with a pillow in front of him. The trapezius, erector spina and levator scapula muscles will be applied with one hand or both hands, starting with general stroking. The intermediate to be used is baby oil or natural oils. The application time will be approximately 20 minutes.
15755033|NCT04817371|Device|Volatile Organic Compounds analysis (e-noses)|VOC analysis in exhaled air with e-noses.
15755034|NCT04817371|Other|Canine odor detection of Volatile Organic Compounds|VOC analysis in sweat by trained dogs.
15755035|NCT04817371|Device|Volatile Organic Compounds analysis (mass spectrometry)|VOC analysis in exhaled air with mass spectrometry.
15755036|NCT04817371|Device|Volatile Organic Compounds analysis in sweat (mass spectrometry)|VOC analysis in sweat with mass spectrometry.
15755038|NCT04817332|Drug|Brensocatib|Selective, competitive, and reversible inhibitor of DPP1
15755039|NCT04817332|Drug|Placebo|Matched placebo
15755040|NCT04817319|Procedure|Oral care with/without aerosolization|"These treatments involve instruments that produce aerosolization: ultrasonic scaler, rotary instrumentation for caries care, dental extraction, tooth polishing.
~These care correspond to examinations of the oral cavity, intraoral X-rays or even periodontal pocket probing."
15755041|NCT04817306|Device|Multi-cancer early detection test|Blood collection and multi-cancer early detection testing
15755042|NCT04817293|Other|Questionnaire|Questionnaire SSD-12 and EQ5D5L
15755043|NCT04817293|Other|medical consultation|Medical consultation during the visit with data collection
15755044|NCT04817280|Other|Ice Swimming|The intervention is not made in the course of a research study. Ice swimming has been introduced earlier by a given group. The group was made up of people who already swim in ice.
15755045|NCT04817267|Device|reSET-O app|The reSET-O app, a prescription digital therapeutic, provides cognitive behavioral therapy for opioid use disorder. The app provides psychoeducation related to opioid use, coping skills, and skills to avoid relapse.
15755055|NCT04817228|Drug|EscharEx (EX-02 formulation)|EscharEx (EX-02 formulation) gel is topically applied on a wound surface of up to 80 cm2 , up to 8 consecutive applications or until a complete debridement is achieved, whichever occurs first.
15755056|NCT04817215|Drug|ORMD-0801|Randomized to receive ORMD-0801 8 mg QD or 8 mg BID or matching placebo
15755057|NCT04817202|Drug|hzVSF-v13 (intravenous, single dose)|Dosage form: 50mg / 100mg / 200mg / 400mg / 800mg /1200mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Route: Intravenous Frequency: Dose at Day 1 (single administration)
15755058|NCT04817202|Drug|hzVSF-v13 (subcutaneous, single dose)|Dosage form: 100mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Route: Subcutaneous Frequency: Dose at Day 1 (single administration)
15755059|NCT04817202|Drug|hzVSF-v13 (intravenous, multiple dose)|Dosage form: 100mg / 400mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Route: Intravenous Frequency: Dose at Day 1, Day 15, Day 29, Day 43, Day 57 (multiple administration)
15755060|NCT04817202|Drug|Placebo (intravenous, single dose)|Dosage form: 0.9% NaCl Solution Route: Intravenous Frequency: Dose at Day 1 (single administration)
15755061|NCT04817202|Drug|Placebo (subcutaneous, single dose)|Dosage form: 0.9% NaCl Solution Route: Subcutaneous Frequency: Dose at Day 1 (single administration)
15755062|NCT04817202|Drug|Placebo (intravenous, multiple dose)|Dosage form: 0.9% NaCl Solution Route: Intravenous Frequency: Dose at Day 1, Day 15, Day 29, Day 43, Day 57 (multiple administration)
15755063|NCT04817189|Drug|NEPA (300mg netupitant/0.5mg palonosetron)|Oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination on Day 1 of each cycle.
15755064|NCT04817189|Drug|Granisetron, 2 mg (oral) or 1 mg (IV) OR Palonosetron, 0.5 mg (oral), 0.25mg (IV) OR Ondansetron, 16 mg (oral) or 8 mg (IV) OR Dolasetron 100 mg (oral) OR Tropisetron 5 mg (oral or IV)|Standard of care will be administered on Day 1 of each cycle.
15755065|NCT04817189|Drug|Dexamethasone, 8 mg (oral) or equivalent IV dose|Dexamethasone (8 mg) will be administered on Day 1 of each cycle.
15755066|NCT04817176|Behavioral|Motivational Interviewing-Cognitive Behavioral Therapy Ketogenic Nutrition Adherence Program|Experimental Arm: The program is a 6-week group, telehealth intervention for older adults with possible MCI. The intervention uses Motivational interviewing and cognitive behavioral therapy strategies to enhance motivation and help participants overcome personal obstacles to following health-behavior recommendations. Specifically, the program examines the use of a Mediterranean ketogenic type of nutrition to target mild cognitive impairment. The intervention is designed to disseminate practical information to help older adults learn how to incorporate healthy Mediterranean ketogenic nutrition into their lifestyle.
15755067|NCT04817176|Other|Ketogenic Nutrition Program|Active Comparator Arm: 6-week group, telehealth intervention for older adults. The intervention is designed to disseminate practical information to help older adults learn how to incorporate healthy Mediterranean ketogenic nutrition into their lifestyle.
15755128|NCT04816643|Biological|BNT162b2 30mcg|BNT162b2 High-Dose (30mcg) level
15755069|NCT04817163|Behavioral|Professionally-administered booster face-to-face CBT-I sessions|"Patients who obtain an ISI score of 8 and more after completing the web-based CBT-I are stepped up and offered to receive up to three 50-min booster sessions of CBT-I offered individually by a psychologist (if needed). Remitted patients (good sleepers; ISI score lower than 8) will receive no further treatment."
15755070|NCT04817150|Procedure|Laparoscopic ventral mesh rectopexy|Conventional laparoscopic ventral mesh rectopexy, as first described by D'Hoore
15755071|NCT04817137|Device|CareTaker PDA Device|Non-invasive blood pressure monitoring
15755072|NCT04817124|Device|Anodal tDCS|Anodal transcranial direct current stimulation (tDCS), 6 sessions with 20 minutes stimulation each (1,5 mA).
15755073|NCT04817124|Behavioral|Intensive cognitive training|Intensive cognitive training of a letter memory updating task, 6 sessions for approximately 20 min
15755074|NCT04817124|Device|Sham tDCS|Sham transcranial direct current stimulation (tDCS), 6 sessions with 30 sec stimulation each (1,5 mA) to ensure blinding of participants.
15755075|NCT04817111|Drug|MIB-626|Two (2) 500 mg Tablets, By Mouth, Daily
15755076|NCT04817098|Behavioral|Journey of Life|The concept underlying the JoL intervention is that caregivers and community members can support each other and their children through reflection, dialogue, and action. JoL addresses children's and adolescents' ecologies by working with caregivers, educators, and community members to understand the importance of their support in protecting children.
15755077|NCT04817085|Device|Visant Medical Canalicular Plug|Plug is inserted into the inferior canaliculi and assessed for 6 months
15755078|NCT04817085|Device|Commercially available canalicular plug|Plug is inserted into the inferior canaliculi and assessed for 6 months
15755079|NCT04817072|Other|Blood sample|Blood sample (20mL) for pro-inflammatory cytokines assay
15755080|NCT04817059|Device|Caseforge headcase|We used a custom-fitted styrofoam head mold designed to reduce head motion during MRI scanning.
15755081|NCT04817033|Procedure|Spinal anesthesia with intraoperative dexmedetomidine sedation|Skin was disinfected and 40mg of 2% Lidocaine was given subcutaneously at lumbar vertebrae 3/4 level. 25 G spinal needle was used and after dura and arachnoidea were pierced 12.5-15 mg of 0.5% Levobupivacaine was applied.
15755082|NCT04817033|Procedure|Spinal anesthesia with intraoperative midazolam sedation|Skin was disinfected and 40mg of 2% Lidocaine was given subcutaneously at lumbar vertebrae 3/4 level. 25 G spinal needle was used and after dura and arachnoidea were pierced 12.5-15 mg of 0.5% Levobupivacaine was applied.
15755083|NCT04817033|Drug|Dexmedetomidine|Dexmedetomidine 0.5 ug/kg during first 10 minutes after successful spinal anesthesia. Dose maintained to keep patient in moderate sedation with closed eyes and Ramsay sedation scale 4 and 5 level
15755084|NCT04817033|Drug|Midazolam|Midazolam 0.25 mg/kg ideal body weight during first 10 minutes after successful spinal anesthesia. Dose maintained to keep patient in moderate sedation with closed eyes and Ramsay sedation scale 4 and 5 level
15755085|NCT04817020|Other|%2 Klorheksidin|Effect on phlebitis
15755086|NCT04817007|Drug|BMS-986158|Specified dose on specified days
15755087|NCT04817007|Drug|Ruxolitinib|Specified dose on specified days
15755088|NCT04817007|Drug|Fedratinib|Specified dose on specified days
15755089|NCT04816994|Drug|Single-dose of cannabis oil|Single-dose of cannabis oil in order to treat acute radicular pain
15755090|NCT04816994|Drug|Control|Giving a sub-linguistic olive oil that is similar in appearance and taste to cannabis oil
15755091|NCT04816981|Device|EBUS-Elastography|Patients undergoing LN staging for lung cancer with EBUS-TBNA will have digital images and biopsy of every LN obtained in accordance with standards of care. Prior to the lymph node biopsy by EBUS-TBNA, elastography will be performed. The relative strain of tissues in the scanned area of the LNs will be displayed as a colour map, with stiffer areas in blue and softer tissue in red. Elastography and B-mode images will be displayed side by side and images recorded and saved onto an external drive for analysis. Elastography images will be fed to the NeuralSeg algorithm which has a network architecture similar to the standard U-Net for image segmentation. The automatically identified regions of interest will be overlaid onto the EBUS Elastography images to extract the LN stiffness measurements. After overlaying, NeuralSeg will determine the proportion of the LN area within 9 previously defined stiffness thresholds.
15755092|NCT04816968|Drug|Cefepime|Cefepime from 3 to 6 gr, based on patient's clinical status, reduced dose based on organ function and physician discretion, in 100cc saline solution in elastomer, perfused in 24 hours.
15755093|NCT04816968|Drug|Piperacillin/tazobactam|Piperacillin/Tazobactam 18 gr, based on patient's clinical status, reduced dose based on organ function and physician discretion, in 100cc saline solution in elastomer, perfused in 24 hours.
15755094|NCT04816968|Drug|Meropenem|Meropenem 3 gr, based on patient's clinical status, reduced dose based on organ function and physician discretion, in 100cc saline solution in elastomer, perfused in 24 hours.
15755095|NCT04816968|Drug|Vancomycin|Vancomycin 30 mg/kg, based on patient's clinical status, reduced dose based on organ function and physician discretion, in 100cc saline solution in elastomer, perfused in 24 hours.
15755096|NCT04816955|Behavioral|Dietary recommendations|Dietary recommendations, with increasing additional behavioural/practical advice or no dietary recommendations
15755097|NCT04816942|Biological|Convalescent Plasma|Two units of ABO compatible COVID-19 convalescent plasma will be administered.
15755098|NCT04816929|Other|Bobath Method|Neurodevelopmental Treatment
15755099|NCT04816929|Other|Task-Oriented Approach|Task-Oriented Treatment
15755100|NCT04816916|Drug|AXA1665|AXA1665 administered TID with food
15755101|NCT04816916|Drug|Placebo|Matching placebo administered TID with food
15755102|NCT04816903|Diagnostic Test|Gyni|Vaginal discharge collection
15755103|NCT04816890|Drug|M1 Pram P037|Subcutaneous administration of M1 Pram P037 in combination with a basal insulin.
15755104|NCT04816890|Drug|Insulin lispro|Subcutaneous administration of insulin lispro in combination with a basal insulin.
15755129|NCT04816643|Other|Placebo|Intramuscular injection
15755130|NCT04816643|Biological|Biological/Vaccine: BNT162b2 3mcg|BNT162b2 Low-Dose (10mcg) level
15755131|NCT04816630|Device|CBC-Diff Monocyte Volume Width Distribution|MDW is part of the CBC-Diff and will be collected but not reported to the physician. MDW will not impact standard of care.
15755193|NCT04816162|Other|normal saline|normal saline 0.9% in a syringe pump
15755105|NCT04816877|Drug|Opioid|Patients with acute pancreatitis will be divided into two groups - patient controlled analgesia (PCA) and physician-directed analgesia (PDA). Opioids are routinely administered as standard of care for treating pain associated with acute pancreatitis. Patients in the PCA group will be receiving opioids via a PCA pump, that the patient can use to self-regulate the dose and timing of drug administration. We will follow a specific protocol that has been designed by our pain physician for the PCA pump. Patients in the PDA arm will receive PRN opioids as directed by the physician, which will be administered by the nurse.
15755106|NCT04816864|Diagnostic Test|extracardiac vagal nerve stimulation (ECANS) + EPS|"The study intervention will consist of 3 steps, all of which will be performed under general anesthesia:
~EPS with the measurement of parameters of atrioventricular conduction and programmed atrial and ventricular pacing.
~ECANS of the right and the left vagus nerve (from the right and left internal jugular vein, respectively; patients will be randomized to start from the right or the left side) performed during: 1) the patient's spontaneous heart rhythm (if present); 2) HB/LBB pacing with permanently programmed impulse parameters; 3) HB/LBB pacing at a pacing threshold of +0.1 V; and 4) 5 minutes after intravenous injection of atropine (0.02-0.04 mg/kg).
~EPS with the measurement of parameters of atrioventricular conduction and programmed atrial and ventricular pacing."
15755107|NCT04816851|Procedure|OZAKI technique|an alternative way of repairing aortic valve, involving the use of autologous pericardium for the aortic leaflet reconstruction. Diseased leaflets are removed carefully. The distance between each commissure is measured with invented sizing apparatus. The new leaflet of the size corresponding to the measured value is trimmed with an original template from glutaraldehyde-treated autologous pericardium. Finally, the annular margin of the pericardial leaflet was running sutured with each annulus. Commissural coaptation was secured with additional sutures. The coaptation of three new leaflets were always insured with direct vision.
15755108|NCT04816838|Drug|Osimertinib|"* Osimertinib 80mg once a day(QD) oral(PO)
~Neoadjuvant Period -If there is no disease progression or unacceptable toxicity, treatment is performed for 2cycles at 1 cycle (28 days) interval
~Adjuvant Period
~- If there is no disease progression of unacceptable toxicity, treatment fis performed for 3years at intervals of 1cycle(28days)"
15755109|NCT04816825|Device|Alkit eSence|Home-based rehabilitation program including computer games and supervised by a physiotherapist.
15755110|NCT04816825|Other|Standard rehabilitation|Standard rehabilitation program at the COPD-Center
15755111|NCT04816812|Behavioral|Exercise intervention|A 12-week aerobic exercise program tailored to the individual patients by physiotherapists using the principles of Frequency, Intensity, Time, and, Type (FITT) aiming to increase or maintain the physical activity level to a weekly moderate activity level. This includes two supervised exercise sessions of 60 minutes per week, combined with one weekly home training session. The type of exercise is planned by a physiotherapist to fit each patient during sessions. We monitor the intervention by training diaries including frequency, intensity, time, and type of exercise (FITT) and the verbal BORG 15-point scale and heart rate monitors. We will also monitor the overall seven days' physical activity level by accelerometry using the AX3 device from the company Axivity at weeks 0 and 12.
15755112|NCT04816812|Behavioral|Lifestyle - online lesson intervention|The investigators offer one online lesson of 15-25 minutes on lifestyle guidance including general advice on healthy living.
15755113|NCT04816799|Behavioral|Startle Adjuvant Rehabilitation Therapy (START)|Exposure to loud acoustic stimulus during training of motor task (in this case speech).
15755114|NCT04816786|Other|no intervention will be administered, this is a retrospective observational study.|no intervention will be administered, this is a retrospective observational study.
15755115|NCT04816773|Device|EVOLUTION® NitrX™|EVOLUTION® NitrX™ Keeled Tibia and EVOLUTION® NitrX™ CS/CR Femur With Cruciate Sacrificing Insert
15755116|NCT04816760|Biological|Peripheral blood samples|Peripheral blood samples at Day 0, Day 7, Day 14, Day 28, Day 90 and Day 180.
15755117|NCT04816747|Biological|Autologous PRP|Participants enrolled in this study will be managed with intradiscal and/or intra-articular injections of autologous PRP according to features of underlying pathology. Participants featuring FJS will be prior to PRP diagnostically and therapeutically injected with local anesthetic in order to verify FJS as the etiology of experienced pain. Injected PRP solution volume is designed to be 0.5-1 ml and 0.5 ml in cases of intradiscal and intra-articular injection, respectively. All participants are planned to receive a single dose of PRP, whilst a maximum of two compromised discs and four facet joints will be treated in each patient.
15755121|NCT04816708|Behavioral|LIFT Mindfulness|Mindfulness is a type of mind-body therapy that promotes a practice of non-judgmental awareness that can alleviate distress by uncoupling emotional reactions and habitual behavior from unpleasant symptoms, thoughts, and emotions. LIFT is a mobile mindfulness app which can assess levels of emotional distress via survey, and subsequently offer mindfulness content that has previously been used in ICU patients, where it was shown to reduce symptoms of depression, anxiety, and PTSD.
15755122|NCT04816695|Device|VOC analysis|VOC analysis in exhaled air with e-noses and mass spectrometry.
15755123|NCT04816682|Drug|Silymarin|Silymarine tablets will be provided irrespective of meal by a registered nurse T.I.D
15755124|NCT04816669|Biological|BNT162b2|Intramuscular injection
15755125|NCT04816656|Other|ePROMs assessment|"At inclusion the patient received a unique login code which he/she used to start the care path. After signing the informed consent on the digital pathway, the patient needed to fill in the questionnaires that were presented at fixed time points throughout this study.
~Based on the data collected from the questionnaires the patient received customized information and advice. In case of COVID-19, the information and advice was based on the guidelines from Sciensano and the Belgian government. If the patient suffered from side effects from the cancer therapy, they received tips and tricks how to manage these complications. The collected data was forwarded to the patient medical file. As such health care workers were be able to use this information in the patients' follow up consultations."
15755126|NCT04816643|Biological|Biological/Vaccine: BNT162b2 10mcg|BNT162b2 Low/Mid-Dose (10mcg) level
15755127|NCT04816643|Biological|BNT162b2 20mcg|BNT162b2 Mid-Dose (20mcg) level
15755132|NCT04816617|Behavioral|Aerobic exercise intervention|The whole exercise lasts for 12 months, consisted of 6-month supervised exercise and 6-month maintenance period. It is moderate -intensity exercise (60-80% Maximum heart rate), each time last for 30 mins (plus 10-minutes for warm-up and cool-down), 3-4 times a week, for the first six months, which will be supervised in person by physical educators and/or physical professionals. In the maintenance period, participants are asked to exercise at the same intensity and frequency, but will not be supervised in person by physical educators/professionals. They will receive reminder on a weekly basis and their physical activities be recorded by accelerometer. Types of exercise will be chosen according to individual school's facility and feasibility, including jogging, fast walking, badminton, running, football etc.
15755133|NCT04816617|Behavioral|Psycho-education|It consists of 6 sections of psycho-education, with topics covering mood regulations and mental well-being. Approximately 1 section in every two months.
15755134|NCT04816604|Drug|GB002 (seralutinib)|Capsule containing GB002 (seralutinib)
15755135|NCT04816604|Device|Generic Dry Powder Inhaler|Generic dry powder inhaler for GB002 (seralutinib) delivery
15755140|NCT04816552|Behavioral|CHoBI7 mHealth program Arm|We will start delivery of this intervention with a pictorial module delivered in the home during two 30 minute visits on cholera transmission and prevention after enrollment. Households will be provided a handwashing station, a covered water vessel, and chlorine tablets. Households will then receive the CHoBI7 WASH mHealth program voice and text messages on handwashing with soap and water treatment bi-weekly.
15755141|NCT04816552|Behavioral|general message on oral rehydration solution (ORS)|general message on oral rehydration solution (ORS)
15755142|NCT04816539|Device|TetraGraph|Use of two monitoring devices of neuromuscular function during surgery
15755145|NCT04816500|Device|Automatic ischemic conditioning treatment instrument|RIC is a non-invasive therapy that performed by an electric autocontrol device with cuff placed on arm. RIC procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on one arm. The procedure will be performed twice daily for consecutive 1 year after enrollment.
15755146|NCT04816500|Drug|Regular treatment|Antiplatelet agents and statins administration, vascular risk factors control.
15755147|NCT04816487|Drug|Potassium Iodide or Glutathione|Patient will receive either Glutathione or Potassium iodide
15755148|NCT04816474|Behavioral|Online education and Phone Counseling Service|Online education total of 6 times for 6 weeks. Phone Counseling Service total of 6 times for 6 weeks
15755149|NCT04816461|Drug|Amodiaquine Sulfadoxine-Pyrimethamin administration|SMC treatment
15755150|NCT04816461|Drug|Dihydroartemisinin-Piperaquine|Roommates treatment if they are positive to malaria
15755151|NCT04816461|Diagnostic Test|Standard HRP2-RDT|Roommates screening with standard HRP2-RDT
15755152|NCT04816461|Diagnostic Test|Highly sensitive RDT|Roommates screening with highly sensitive RDT
15755153|NCT04816448|Other|cervical mobilization (Headache SNAG)|For cervical mobilization the patient's position is sitting on a chair in the erect posture. The therapist handled C2 spinous process with the middle phalanx of one hand. With the other hand, he performed ventral glide asked the patient to move neck in all directions (Flexion, Extension, Side bending and rotation) one by one and then slowly move the neck back to its starting position while the therapist maintained the ventral glide.
15755154|NCT04816448|Other|Sub-occipital myofascial release|"For the application of the technique , the patient position is supine lying with the head fully supported on therapist's hands and therapist places 3 middle fingers just inferior to the nuchal line, lifts the fingers tips towards the ceiling while resting the head on the table and then therapist will apply a gentle upward pull. This procedure done for 2 to 3 minutes and 5 to 7 repetitions, 3 sessions per week on alternate days were given for 6 weeks.
~Evaluation was done before treatment, during treatment at 4th week and after treatment at 6th week. Outcomes will be measured by NDI, PNRS and Universal Goniometer."
15755155|NCT04816435|Diagnostic Test|Ultrasound test|Ultrasound evaluation of airway
15755156|NCT04816422|Other|Proprioceptive neuromuscular facilitation|"rocedure
~Bilateral upper extremity pattern for trunk by Chopping, Lifting
~Bilateral lower extremity pattern for trunk.
~Trunk lateral flexion.
~Combination patterns for the trunk by Upper and lower trunk flexion, Upper trunk flexion with lower trunk extension, Upper and lower trunk extension, Upper trunk extension with lower trunk flexion."
15755157|NCT04816422|Other|Conventional treatment|"Group 2 has received conventional trunk exercise program for 45 min/day, 4 days
~/ week for the period of 4 weeks the intervention includes static and dynamic functional trunk movement and strengthening exercise to the trunk muscles which includes motor developmental patterns, basic trunk movement, trunk-arm linked movements, trunk-leg linked patterns in sitting, transfer activities, with 2 minutes rest in between the repetition of each set, Progression will be made by increasing the repetition and resistance According to individual ability."
15755158|NCT04816409|Other|conventional therapy|"Range of motion and Resistance training Linear actions are used to regularize extensor muscle tone (Neck extensors, back extensors hip extensors, knee extensors).(49) Postural control exercises Bouncing on gym ball in sitting, kneeling, or standing
~- Linear swinging using a platform and swing, glider, hammock, and barrel; swinging in the kneeling, standing, sitting,"
15755186|NCT04816214|Drug|carboplatin|concentrate for solution for intravenous use
15755187|NCT04816214|Drug|osimertinib|tablet for oral use
15755188|NCT04816201|Other|Electroacupuncture|Electroacupuncture at Xuanji (CV21), Danzhong (CV27), Qihai (CV06), Guanyuan (CV04), and bilateral Liangmen (ST21) and Zusanli (ST36).
15755189|NCT04816188|Other|Exercise Therapy and Activity Modification|Daily lower leg strengthening exercises Therapy and pain-guided activity modification.
15755190|NCT04816175|Behavioral|Acquire Therapy|This intervention is an operant conditioning based neurorehabilitation protocol for the promotion of psychomotor function
15800881|NCT04444011|Drug|Bismuth|Bismuth is to protect the gastric mucosa
15755159|NCT04816409|Other|Neurodevelopmental therapy|"Starting Posture
~Start and evaluate the supreme effective posture to move from(usually straight)
~Reassemble to mid plane (head/trunk)
~Neutral position of body (47) Identify the Missing Components Detect starting posture and compare to normal.(47)
~Neurodevelopmental therapy application :
~Tonic postural extensor muscle strengthening:
~Push-pull scooter board games contrary to resistive tubing strips.(48) 2. Developmental movement patterns training: Obstacle crawl, hold swing's ropes in kneeling and half kneeling position, throw balls to aim kneeling and standing position. Manual Cues .Use hands on key points of control to assist normal posture, movement and prevent abnormal posture and movement. Balance and corrective reactions was established by means of ball and tilt board after the development of the skill of
~li"
15755160|NCT04816396|Behavioral|reminiscence Therapy|Application Stages of Reminiscence Therapy Based on Roy Adaptation Model Week 1 (Session 1):Introduction-Meeting-Infancyand Family Life Week 2 (Session 2):Childhood and School Years Week 3 (Session 3):Unforgettable Historical Periods,Old movies, Old Songs Week 4 (Session 4):Loved, meals,Desserts and Recipes,Nutrition Style Week 5 (Session 5):Work and Marriage Week 6 (Session 6):Home and Garden Works,Animals, Plants Week 7 (Session 7): Travels, Vacation Memories Week 8 (Session 8): Celebration Memories, Evaluation Posttest Closing.
15755161|NCT04816383|Other|"Breastfeeding at AU Apple-Based Smartphone Application"|This is a free Apple-Based Smartphone Application the participant can download. In the application, there is information and tips for breastfeeding success and continuation, as well as information on additional resources both online and in the community as a whole.
15755162|NCT04816370|Diagnostic Test|FSFI|2 group and 2 subgroup
15755163|NCT04816357|Other|Questionaire|only questionaire
15755164|NCT04816344|Procedure|Outpatient Anesthesia|The inclusion criteria were children aged between 2 and 10 years, undergoing outpatient anaesthesia for elective MRI under sedation, and classified as American Society of Anesthesiologists (ASA) grade I-II. The study exclusion criteria were defined as difficult airway, allergies to the study drugs, asthma, severe central nervous system disease (eg, brain tumour, uncontrolled seizures), mental motor retardation, the application of another procedure after MRI sedation, and those whose parents declined to participate in the study.
15755165|NCT04816331|Other|Medical records and clinical measurements|"Medical records and clinical measurements: Detailed antenatal, birth, resuscitation, oxygen requirements throughout inpatient stay and detailed neonatal intensive care management will be collected. Therapeutic Hypothermia treatment including initiation, duration and clinical examination, and investigations such as scans. In addition, clinical data will include medication, neurological (paediatric developmental psychologist assessment and Bayley Scales of Infant and Toddler Development) and multiorgan examination.
~Questionnaires for caregivers to assess social-emotional and adaptive domains.
~Tissue samples analysis and processing: Samples of blood, urine and saliva will be used for laboratory testing.
~Biomarker correlation with Multiorgan outcomes using statistical analysis: Data collected from medical records, clinical measurements, questionnaires, and tissue processing will be analysed using SPSS software for statistical analysis and modelling."
15755166|NCT04816318|Other|Social and public health measures against COVID-19|"Viral spread (for both outcomes) 1.1. Total lockdown 1.2 Partial lockdown (geographical, step-wise/graduated response) 1.3 Curfew 1.4 School closure 1.5 Closure of shopping malls, gyms, churches, parks 1.6 Remote work 1.7 Restrictions to national/subnational mobility 1.8 Prohibition of mass gatherings
~Health systems response (for COVID-19 deaths outcome) 2.1 Interventions to increase testing capacity 2.2 Interventions to increase the number of ICU/critical beds
~Mitigation strategies (for both outcomes) 3.1 Direct social assistance (in-kind/cash) 3.2 Cash transfer 3.3 Withdrawal of pension funds"
15755167|NCT04816318|Other|Control|The comparator is a counterfactual outcome defined as the projection of the pre-intervention trend to simulate what would have happened if the policy had not occurred (see Statistical Analysis Plan for definitions)
15755168|NCT04816305|Device|rTMSc|In all rTMS protocols the patient will remain seated in a comfortable chair with adjustable arms and head rests. Before the start of the conventional rTMS (rTMSc), the resting motor threshold (RMT) of the first dorsal interosseous muscle contralateral to the lesioned hemisphere will be determined. The RMT will be defined as the lowest RMT intensity necessary to produce a motor evoked potential amplitude greater than or equal to 50 µV in at least 5 out of 10 attempts.
15755169|NCT04816305|Behavioral|Neurofunctional physiotherapy|All patients will be submitted to a protocol of exercise with different levels according to motor learning, neuroplasticity principles and motor impairment. All physiotherapists will be trained prior to the study.
15755170|NCT04816305|Device|rTMS sham|During the rTMS sham sessions the same procedures will be used as the rTMSc protocols, however, the magnetic stimulator and its coil will be turned off.
15755171|NCT04816292|Procedure|Active Comparator: Hot Snare Polypectomy|Hot Snare Polypectomy with the use of electrocautery for the resection of polyps.
15755172|NCT04816292|Procedure|Experimental: Cold Snare Polypectomy|Cold Snare Polypectomy without the use of electrocautery for the resection of polyps.
15755173|NCT04816266|Device|Iol master|Iol master measures the distance between anterior pole of the cornea and the anterior surface of the lens to calculate the anterior chamber depth
15755174|NCT04816266|Device|Pentacam|The Pentacam HR calculates Anterior chamber depth from the corneal endothelial layer along a line from the apex of the cornea to the anterior surface of the lens
15755175|NCT04816253|Drug|Normal saline|Normal saline irrigation and No other drug placed after extraction
15755176|NCT04816253|Drug|Hyaluronic acid|Immediately after removal of impacted tooth (hyaluronic acid) placed in extraction socket
15755177|NCT04816253|Drug|Methylprednisolone|Methylprednsolone will be injected half an hour preoperatively
15755178|NCT04816253|Drug|Methylprednisolone and Hyaluronic acid|Methylprednisolone will be injected half an hour preoperatively and Immediately after removal of impacted tooth (hyaluronic acid) placed in extraction socket
15755179|NCT04816240|Drug|Midodrine|5mg thrice daily and will be increased every 3 days upto 15 mg thrice daily with target MAP (>75 mm and <90)
15755180|NCT04816240|Biological|Albumin|80grams/week for 2 weeks followed by 40gram/week
15755181|NCT04816240|Other|Standard Medical Treatment|Standard Medical Treatment
15755182|NCT04816240|Other|Placebo|Placebo
15755183|NCT04816214|Drug|capmatinib|film-coated tablet for oral use
15755184|NCT04816214|Drug|pemetrexed|concentrate for solution for intravenous use
15755185|NCT04816214|Drug|cisplatin|concentrate for solution for intravenous use
15755194|NCT04816149|Behavioral|VA Standard Suicide Intervention|Our active control condition is standardized and contains the elements of standard practice suicide-specific intervention delivered at the VA, which include: 1) suicide risk assessment using the CSSR-S, 2) VA Safety Planning Intervention, 3) timely referral to VA mental health outpatient care, including couples intervention (engagement will be tracked), and 4) Suicide Prevention Coordinator (SPC) follow-up contacts (which have been found to significantly reduce suicidal behavior).
15755195|NCT04816149|Behavioral|Treatment for Relationships and Safety Together (TR&ST)|"TR&ST consists of twelve 90-minute sessions delivered in four phases. During phase one, couples receive a tailored cognitive-behavioral conceptualization of suicide and relationship distress based on clinical interview, as well as psychoeducation about their bidirectional influences. They also engage in behavioral activation focused on positive couple activities, emotion regulation, distress tolerance, and conflict management strategies. In phase two, couples learn communication skills and discuss suicidal thoughts and behaviors, as well as their relationship challenges that interact with suicidal thoughts and behavior. Phase three is focused on conjoint thought challenging to shift dysfunctional cognitions related to suicide and relationship problems. Finally, in phase four, couples engage in relapse prevention exercises and outline individual and couple values in order to create a life worth living moving forward."
15755196|NCT04816136|Other|Sleep recording (already done)|Sleep recording (already done)
15755197|NCT04816123|Drug|[14C]Donafenib|Each volunteers received a single 300 mg dose of [14C]donafenib (toluene sulfonic acid) containing a radioactivity dose of 120 μCi as an oral suspension, in fasting within 5 minutes.
15755198|NCT04816110|Biological|mineralized plasmatic matrix with collagen membrane|"Two tubes of 9 ml of patient's venous blood were collected, the tubes were placed in the centrifuge machine at 2500 rpm for 12 minutes. The resultant product consists of the following two layers:
~A yellow plasma liquid on the top of the tube.
~Red blood cells at the bottom. - The yellow part was collected using a syringe and added to a cup that contains the bone grafting material (hydroxyapatite 20% + β-TCP 80%). The whole preparation was mixed for few seconds to obtain MPM.
~After implant placement, the buccal bone defect was grafted with MPM and covered by collagen membrane"
15755199|NCT04816110|Biological|mineralized plasmatic matrix (MPM) without collagen membrane|"Two tubes of 9 ml of patient's venous blood were collected, the tubes were placed in the centrifuge machine at 2500 rpm for 12 minutes. The resultant product consists of the following two layers:
~A yellow plasma liquid on the top of the tube.
~Red blood cells at the bottom. - The yellow part was collected using a syringe and added to a cup that contains the bone grafting material (hydroxyapatite 20% + β-TCP 80%). The whole preparation was mixed for few seconds to obtain MPM.
~After implant placement, the buccal bone defect was grafted with MPM."
15755200|NCT04816097|Drug|Dexamethasone phosphate|4 doses of dexamethasone 6mg IM 48h before elective CS.
15755201|NCT04816084|Diagnostic Test|Anti-SARS-CoV2 Serology|"Diagnostic Test: Anti-SARS-CoV2 Serology A blood sample is collected by venipuncture at Day 0. The anti-SARS-CoV2 serological status is measured by with fully automated MAGLUMI 2019-nCoV IgG and IgM chemiluminescence immunoassays (EUROBIO®)
~Other: Questionnaire
~Data concerning personal exposure factors are collected in a questionnaire:
~Socio-demographic factors: sex, age,
~known risk-factor for Covid-19
~Professional factors: Employment (type, work time, location), protective measures put in place to reduce the risk of contamination
~Non-professional factors: Contact with infected individuals, carrying of protective equipment and compliance with barrier measures, transport and accomodation modalities during holidays"
15755202|NCT04816071|Drug|Essential amino acids|Dietary Supplement
15755203|NCT04816071|Dietary Supplement|Maltodextrin|Control
15755204|NCT04816058|Behavioral|Determining the level of ankle instability|Ankle instability
15755205|NCT04816045|Procedure|Electrochemotheraoy|Electrochemotherapy (ECT) is endoscopic electroporation in combination with bleomycin
15755206|NCT04816045|Procedure|Electroporation with saline (placebo)|Electroporation in the control group is performed endoscopically with saline
15755207|NCT04816032|Other|Pennebaker's expressive writing intervention|It focuses on the emotional aspect of the written event
15755208|NCT04816032|Other|Neutral writing|Description of neutral topics with less emotional involvement
15755209|NCT04816019|Biological|ChAdOx1 nCov-19|A single dose of ChAdOx1 nCov-19 delivered intranasally (IN)
15755210|NCT04816006|Behavioral|Aerobic Exercise Training|Breast cancer survivors in the intervention group will participate in a 24-week moderate intensity exercise program led by community-based fitness center personal trainers. Individually-tailored exercise prescriptions will be developed based upon each participant's baseline maximal graded exercise test (heart rate corresponding with %VO2 peak) and symptom limitation. Sessions will be progressive in nature such that the volume of exercise increases across weeks. Treadmill walking is the primary mode of exercise. However, participants will be permitted to use other cardiovascular equipment (e.g., elliptical machines, stationary bicycles) as prescribed by their exercise trainer. The trainer will supervise three weekly exercise sessions in Weeks 1-2, two in Weeks 3-4, one in Weeks 5-8, biweekly across weeks 9-16, and monthly in Weeks 17-24 (N=20 supervised sessions).
15755211|NCT04816006|Other|Health Education (Active comparator)|Breast cancer survivors in the Health Education group will participate in 6 in-person and 9 digital sessions with an interventionist and receive 5 monthly newsletters (N=20 total contacts) across 24 weeks. The program will include cancer support and discussion of cancer-related wellness topics (e.g., stress management, coping). Control group participants will be offered a 6-month fitness Center membership upon study completion.
15755212|NCT04815993|Drug|SYN-020 delayed release capsule|SYN-020, is an opaque, white, size 3 HPMC capsule for oral administration containing enteric-coated, delayed-release pellets.
15755213|NCT04815980|Other|Exercise|Home-based mat-based Pilates intervention 3 times a week for 12 weeks prepared by a certified Pilates instructor.
15755214|NCT04815967|Drug|rimabotulinumtoxinB|IM injection on Day 1, and Week 13 (±2 weeks)
15755215|NCT04815967|Drug|Placebo|IM injection on Day 1, and Week 13 (±2 weeks)
15755216|NCT04815954|Procedure|Urinary catheter removal|Removal of urinary catheter which was placed during kidney transplantation.
15755217|NCT04815941|Other|Soft ball tissue release exercises|"Exercise program were given to patients with low back pain secondary to hip muscle tightness using soft balls, i.e. tennis balls plus core stability exercises.
~3 days a week for four weeks."
15755218|NCT04815915|Other|Graston technique|Graston tool was used to treat patients 3 times in a week according protocol for 6 weeks' treatment plan with extensions bised exercises protocol following pattern of APTA.
15755219|NCT04815902|Drug|Fisetin|Oral Fisetin 20 mg/kg taken for 10 days total.
15755220|NCT04815902|Drug|Losartan|12.5 mg oral Losartan taken for 30 days total.
15755221|NCT04815902|Drug|Placebo - Losartan|Losartan appearance-matched microcrystalline cellulose placebo. 12.5 taken for 30 days total.
15755222|NCT04815902|Drug|Placebo Fisetin|Fisetin appearance-matched microcrystalline cellulose placebo. 20 mg/kg taken for 10 days total.
15755223|NCT04815889|Behavioral|PRIMUS parent training Group|"The parents offered a PRIMUS Group-based parent support program for 5 half days. This parenting education for preschool children with developmental problems but without the requirement of diagnosis Hellström (2019) has been designed and tested in other parts of the country but not scientifically validated, which can be done in this study. The teachers will be offered a teacher group for half a day together with the parents.
~For those families who need more intervention the PLUSS toddler team (from the specialist Healthcare) is established.
~The PLUSS toddler team makes a management plan as referral to Habilitation Center, Child and Adolescent Psychiatry, Speech Therapist, or interventions eg:
~Support in the child's everyday environment home / preschool
~Targeted Parent Groups: toilet, sleep, food, everyday structure, handle behavioural problems
~Web courses"
15755227|NCT04815863|Diagnostic Test|Assessment of somatic symptom disorder with SSS-CN|SSS-CN questionnaire is used to assess the presence and severity of the somatic symptoms
15755228|NCT04815863|Diagnostic Test|Assessment of depressive symptoms disorder with PHQ-9|PHQ-9 questionnaire is used to assess the presence and severity of the depressive symptoms
15755229|NCT04815863|Diagnostic Test|Assessment of anxiety disorder with GAD-7|GAD-7 questionnaire is used to assess the presence and severity of the anxiety disorder
15755230|NCT04815837|Behavioral|Intervention|"Viewing a video promoting Human Papillomavirus (HPV) vaccination: participants will watch a 5-minute online video promoting MSM's uptake of HPV vaccination. In the video, a peer MSM discussed about the risk of contracting HPV and having anal cancers among MSM, severe consequences of HPV-related diseases, as well as the benefits of HPV vaccination. He also demonstrated the procedures of taking up HPV vaccination in the collaborative private clinics, which portrayed caring, privacy guaranteed, and non-judgmental environment.
~Receiving the discount coupons: each participant will be given a discount coupon. By using the coupon, one can enjoy a 10% discount for taking up three doses of HPV vaccines at a collaborating private clinic.
~Visiting the project webpage: Participants can assess the project webpage by scanning the QR code on the discount coupon.
~Follow-up reminders: participants received five reminders at Month 1, 2, 4, 6, & 8."
15755232|NCT04815811|Other|Blood collection|Blood samples collections to evaluation of the potential role of the sex chromosomes in the innate immune response by analyzing inflammatory cytokine production (IL-1β, IL-6, IL-8, IL-10, TNF-α and IFN-α), studying the cell diapedesis receptor CD99 on PMNs, monocytes, and lymphocytes, analyzing the contribution of X-linked genes of the TLR pathways and the influence of X-linked miRNAs.
15755233|NCT04815811|Other|Stool collection|Fecal sample collection to delineate microbiome contribution, we will study the gut microbiota in faecal samples obtained from the recruited patients.
15755234|NCT04815798|Combination Product|Bacteriophage-loaded Microcapsule Spray|Study intervention consists of a dosage-metered airless spray containing a cocktail of 14 bacteriophages encapsulated in a biodegradable polymer. This bacteriophage product will be delivered topically every 3 days for 56 days or until wound has healed.
15755235|NCT04815798|Combination Product|Placebo|Placebo intervention consists of a dosage-metered airless spray containing a buffer solution analogous to the study intervention. This placebo will be delivered topically every 3 days for 56 days or until wound has healed.
15755236|NCT04815798|Procedure|Standard of Care|Standard of care consists of but is not limited to offloading, positioning, cleansing, debridement, and wound dressing. A topical antimicrobial hydrogel will applied to wounds with signs of localized infection.
15755237|NCT04815785|Device|TaurusOne® transcatheter aortic valve replacement system|The TaurusOne® Transcatheter Aortic Valve System consists of an aortic valve, an associated delivery catheter and a loading system. The aortic valve consists of a self-expanding nitinol frame, a sealing skirt and valve leaflets, which are made of bovine pericardium. The delivery system is mainly composed of conical head, opacity ring, inner tube, top ring, middle tube, outer tube, booster rod, stress diffusion catheter, handle, etc. The outflow end of the aortic valve is provided with three fixing holes evenly distributed on the circumference on the top ring of the delivery catheter, so as to facilitate the installation, delivery and release of the aortic valve. Before the operation, the aortic valve needs to be installed into the sheath of the delivery catheter as required.
15755238|NCT04815759|Other|routine dental restorative procedures|pulp and restorative therapy
15755239|NCT04815746|Behavioral|Cognitive Behavioral Therapy (CBT)-based skills|The CBT skills target reducing anxiety, (e.g., relaxation), changing negative appraisals (e.g., cognitive restructuring), coping skills training (e.g., enhancing adaptive skills), behavioral activation, interpersonal skills (e.g., communication skills) and building or enhancing social networks. The intervention will be administered online, and each module will last about 1-hour.
15755240|NCT04815746|Behavioral|Standard Education|Patients randomized to standard clinical care will receive standard education based on various resources (e.g., National Cancer Institute) relevant to pancreatic cancer.
15755241|NCT04815733|Procedure|Mandatory ventilation|Use PCV-VG
15755242|NCT04815733|Procedure|pressure support ventilation|Use PSVpro
15755272|NCT04815421|Other|the paste group|Patients in the paste group were treated with Nanxing paste on the affected region include shoulder, neck or back and no more than 3 pieces. The paste lasted for 24 hours and then peeled it rested the pasted region for 24 hours and changed another paste on the pain region. The therapy duration was 6 days.
15755244|NCT04815707|Procedure|Occcult hernia repair|The occult hernia will be repaired during the same inguinal hernia repair
15755245|NCT04815694|Radiation|RT Dose escalation in LARC patients with an Early Regression Index > 13.1 at second week on nCRT|The initial radiotherapy treatment will consist in delivering 55 Gy in 25 fractions on GTV plus the corresponding mesorectum of 45Gy in 25 fractions on the whole pelvis. Chemotherapy with 5-fluorouracil (5-FU) or oral capecitabine will be administered continuously. A 0.35 Tesla Magnetic resonance image will be acquired at simulation and every day during MRgRT. At fraction 10, ERI will be calculated. If ERI will be inferior than 13.1 the patient will continue the original treatment. If ERI will be higher than 13.1 the treatment plan will be reoptimized considering the residual tumor at fraction 10 as new therapy volume, where the dose will be intensified to reach 60.1 Gy.
15755248|NCT04815668|Other|Acupuncture group|Sterile single-use stainless steel needles (size 0.35 mm × 55 mm) (YiDaiFu brand, Suzhou Tianyi Acupuncture Instrument Co., Ltd., Suzhou, China) will be utilized. Participants in lateral position, the acupoints area will be sterilized with 75% alcohol. To stimulate SPG, the needles will be inserted in the medial superior anterior direction to a depth of approximately 55 mm33 until the participants report a special sensation radiating toward the nose or the upper teeth. After that, the needle will be withdrew slightly. The needles will be retained for 30 minutes after three stimulation. Rescue medication are permitted when participants feel that their symptoms are intolerable.
15755249|NCT04815668|Other|Placebo acupuncture group|The acupuncture procedure will be similar to that of the acupuncture group. After sterilizing the skin, the 0.35 × 25 mm disposable needle will be vertically inserted at SPG acupoint about 3-5 mm. No needle manipulation will be conducted to avoid the deqi response. Rescue medication are permitted when participants feel that their symptoms are intolerable.
15755250|NCT04815668|Other|Rescue medication group|Participants in the rescue medication group do not receive acupuncture treatment during the study period. They will be only allowed to use rescue medication. They have the option of 4 weeks (up to 8 sessions) of acupuncture free of charge at the end of the follow-up period.
15755251|NCT04815655|Procedure|Cartilage tympanoplasty|is the reconstruction of the tympanic membrane (TM) by using catilage
15755252|NCT04815642|Radiation|radiotherapy|Hypofractionated radiotherapy concomitantly with weekly boost
15755253|NCT04815629|Radiation|Radiotherapy|Radiotion therapy squamous cell carcinoma in cancer bladder
15755254|NCT04815616|Radiation|Radiotherapy|Capecitabine with adjuvant radiotherapy in treatment of Early Stages Breast Cancer
15755255|NCT04815603|Drug|BGE-117|Active Treatment
15755256|NCT04815603|Other|Placebo|Placebo
15755257|NCT04815590|Drug|Buprenorphine extended-release injection|Once-monthly subcutaneous injectable buprenorphine product; Extended-Release Injectable Buprenorphine 100 mg/0.5 mL prefilled syringe; Extended-Release Injectable Buprenorphine 300 mg/1.5 mL prefilled syringe.
15755258|NCT04815564|Device|Invisalign|Invisalign clear aligner system
15755259|NCT04815551|Drug|AV-380|AV-380 is an immunoglobulin (Ig) G1 monoclonal antibody (mAb) intended to bind circulating human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia.
15755260|NCT04815551|Drug|Placebo|Placebo is sterile liquid for IV infusion.
15755261|NCT04815538|Behavioral|the subscale of Health-Promoting Lifestyle Profile II|"Nutritional health behavior included the following nine items: choose a low-fat diet; limit the use of sugars; eat servings of bread, cereal, and rice; eat servings of fruit; eat servings of vegetables; eat servings of meat, poultry, fish, dietary guidelines"
15755262|NCT04815512|Diagnostic Test|Liver function tests.|serum alanine amino transferase (ALT), aspartate amino transferase (AST), albumin (ALB), alkaline Phosphatase (ALP), total bilirubin.
15755263|NCT04815512|Diagnostic Test|kidney function tests|creatinine , urea and serum uric acid will be analysed in the serum.
15755264|NCT04815499|Dietary Supplement|Food supplement|ARACOMPLEX® is an authorized food supplement that contains maca extract, vitamin complexes and ions, and that improves the quality of life of the patient.
15755265|NCT04815499|Dietary Supplement|Placebo|Placebo has a composition that makes its weight and organoleptic characteristics are identical to ARACOMPLEX®.
15755266|NCT04815486|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|Active rTMS in 10 daily sessions in two weeks of sequential application of: 90% RMT at 1Hz, 1000 pulses/day, 25s inter train on M1 of lesioned hemisphere and 90% RMT at 10Hz, 1000 pulses/day, 50s inter train on M1 of healthy hemisphere.
15755267|NCT04815486|Device|Motor Imagery (MI) through a Brain-Computer Interface (BCI) training platform in Virtual Reality (VR) with NeuRow|"Using NeuRow (NeuroRehabLab, Lisbon, Portugal), 12 non-consecutive sessions (Monday, Wednesday and Friday) in four weeks will be applied. Patients will use a virtual reality system to visualize a customized videogame where they will see a boat and two high fidelity virtual arms gripping two oars in the first-person view. They have to imagine the movement of each corresponding hand, EEG will be acquired through a BCIs system with 32 active electrodes and will give feedback to rotate each oar and progress, observing the movement imagined on screen.
~The goal of the task is to collect as many flags as possible. The NeuRow treatment will be performed for 25-30 minutes each session, divided into 3 series of 7 minutes to prevent fatigue."
15755268|NCT04815473|Procedure|Valvulotomy|Valvulotomy of the venous valves
15755269|NCT04815460|Behavioral|High intensity-interval training (HIIT)|Subjects performed HIIT (3-min intervals at 40% and 80%VO2peak) on a bicycle ergometer for 30 min/day, 5 days/week for 6 weeks.
15755270|NCT04815460|Behavioral|Moderate intensity-continuous (MICT)|Subjects performed MICT (sustained 60%VO 2max) on a bicycle ergometer for 30 min/day, 5 days/week for 6 weeks.
15755271|NCT04815434|Other|Interview|Interviews will be conducted.
15755273|NCT04815421|Other|the meridian group|Patients in the meridian group were treated with dredging the same side three yang meridian techniques(include the gliding techniques of deep tissue massage on three yang meridians of back hand (the second, fourth and fifth metacarpal bone); pinching and kneading the second, fourth and fifth phalanges of fingers of the affected side hand; Encourage the patient to try his best to roll his neck to the most tolerable degree during dredging the meridian) and the total time was about 3 to 5 minutes according the tolerance of every patient . The massage will not stop until the meridian route was relatively smooth, soft and thermal or light red. The sequence of massage is Hand Yangming meridian(LI) the first, Hand Taiyang meridian(SI) the second and Hand Sanjiao(SJ) the last. The frequency of massage was once a day.
15755274|NCT04815408|Drug|BGB-A317|PD-1 antibody，Tislelizumab (BGB-A317)
15755275|NCT04815408|Drug|albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5|albumin-bound paclitaxel 260mg/m2 , Carboplatin AUC 5
15755276|NCT04815395|Drug|Oxytocin|Administration of oxytocin (24IU) orally
15755277|NCT04815395|Drug|Oxytocin|Administration of oxytocin (24IU) intranasally
15755278|NCT04815395|Drug|Placebo|Administration of placebo orally
15755279|NCT04815382|Other|Dynamic Upper Limb Orthosis|"The dynamic upper limb orthosis extends from subdeltoid level to 10 mm distal to the metacarpal-phalangeal joints. The orthosis will be tailored to include 20 degrees of wrist extension and to abduct the thumb. They made from nylon and lycra.
~The orthosis will be used throughout the day, being removed when the patient lies down.
~The orthosis will be used during 3 months"
15755281|NCT04815343|Device|Naída CI M90 Sound Processor (hearing aid and cochlea implant sound processor)|Speech perception measures, Hearing thresholds, Enjoyment rating, Sound identification, Subjective feedback
15755282|NCT04815330|Other|increment sweep gas flow|If a sweep gas flow through the membrane lung increment has been decided upon to relieve dyspnea, a new recording will be made after each scan increment and the patient will be asked at each step.
15755283|NCT04815330|Other|non-invasive ventilation|In ventilated or non-ventilated patients in whom the decision to implement non-invasive ventilation has been made, an increase in PEEP in 2 cmH2O steps without exceeding a plateau pressure of 25 cmH2O and a VT of 10ml/kg of the patient's theoretical weight will be achieved.
15755284|NCT04815317|Other|Auditive stimulation|"The auditory stimulation will consist of listening to relaxing pieces of music from MP3 files from the International Center for Music Therapy (Noisy le Grand, France).
~Listening will be done through noise-cancelling headphones (PLANTRONICS, Gamecom 780, Santa Cruz, California, USA) for 10 minutes."
15755285|NCT04815317|Other|Sensitive stimulation|Sensitive stimulation will consist of administering fresh air to the patient's face by means of a fan without blades (DYSON AM01, Malmesbury, UK) for 10 minutes.
15755286|NCT04815317|Other|Auditory control|"The auditory control condition will consist of listening to a pink noise. The pink noise, like the white noise, is a normalized noise. The sound produced on a TV set that is out of adjustment during the snow effect is a representative example of such noise. Pink noise is a random signal whose power spectral density decreases by 3dB per octave. This signal is closer to the sensitivity of the ear than white noise."
15755287|NCT04815317|Other|Sensitive control|The sensitive control condition will be achieved by administering fresh air on the calf.
15755288|NCT04815304|Diagnostic Test|peripheral lymphocytes subsets|The data were collected during the first and the second wave of epidemic in COVID-19 patients with acute respiratory distress syndrome. At the moment of hospitalization, at the moment of intensive care unit admission and during the in intensive care unit staying, the following data were collected: peripheral lymphocyte subsets were measured by multiple-color flow cytometry, chest computed tomography and ultrasonography scans (lung ultrasound score, diaphragmatic thickness and motion), arterial blood gas analysis parameters (pH, partial pressure of carbon dioxide, partial pressure of oxygen, concentration of hydrogen carbonate, base excess, and arterial oxygen saturation ), and pain assessed by using numeric rating scale. Macroscopic and microscopic hypopharynx and larynx damages were also evaluated by video-laryngoscopy and light miscoscopy.
15755289|NCT04815291|Device|Receives SCOUT at biopsy|SCOUT Reflector
15755290|NCT04815278|Behavioral|Immediate Chronic Disease Prevention Program (CDPP)|The CDPP is an adaptation of the Diabetes Prevention Program (DPP). It will take place over a 24 week period and involve online instruction and individualized lifestyle coaching sessions. The online classroom curriculum includes 8 modules: Goal setting, self-monitoring and problem solving (M1), Managing stress and negative thoughts (M2), Healthy eating (M3), Taking more steps (M4), Keeping alcohol in check (M5), Lifestyle change (M6), Taking charge of what (and who) is around you (M7), and Staying motivated (M8). The lifestyle coaches will meet in person and over the phone intermittently over the 24 week period (Weeks 2, 4, 6, 10, 12, 16, 24).
15755291|NCT04815278|Behavioral|Workplace Equity, Job and Health Supports Employer Intervention|The employer intervention combines implicit bias awareness training for supervisors of hired DSS-E clients, and regular, structured, interactions between supervisors and DSS-E hires.
15755292|NCT04815278|Behavioral|Delayed, attenuated Chronic Disease Prevention Program (CDPP)|Participants will have access to a delayed, attenuated online-only version of the CDPP at the time they complete the 12 month data collection. This version will provide all modules, self-monitoring options (including through use of a Fitbit contingent on the completion of the 12 month data collection) but will not include face-to-face or phone lifestyle coach sessions.
15755293|NCT04815265|Drug|Remimazolam|Remimazolam is used for sedation
15755294|NCT04815265|Drug|Dexmedetomidine|Dexmedetomidine is used for sedation
15755295|NCT04815252|Behavioral|CHIME|CHIME is a professional development program to provide knowledge and skills for nurturing early childhood educator mindfulness, compassion and socio-emotional learning. CHIME is a manualized curriculum delivered by a trained facilitator. The intervention consists of a 2-hour overview and seven weekly sessions, each lasting 90 minutes. Sessions can be delivered online or in-person.
15755296|NCT04815239|Behavioral|Interpersonal and Social Rhythm Therapy (IPSRT)|Interpersonal and Social Rhythm Therapy (IPSRT) is an evidence-based treatment for BP adults that prevents or delays mood episodes by stabilizing sleep and daily routines.
15755297|NCT04815239|Behavioral|The Healthy Lifestyle Behavior Intervention (HL)|HL includes structured psychoeducational modules that aim to teach patients about health risks and help them achieve a balanced lifestyle to optimize physical and mental health.
15755298|NCT04815226|Device|Peristeen Transanal Irrigation|Using Peristeen Transanal Irrigation twice per week for 12 weeks
15755299|NCT04815213|Biological|expanded autologous bone marrow derived MSC|Autologous bone marrow-derived mesenchymal cells (BMMSCs), dose 20 million cells/ovary
15755300|NCT04815200|Device|Copper Nickel titanium arch wire|Patient will receive 0.014 round Copper Nickel titanium CuNiTi archwire and will be ligated using a ligature wire.
15755301|NCT04815187|Drug|Montelukast|Each subject will be given a drug diary to record when they took the drug and any symptoms that they are experiencing, and will bring this diary and any unused pills to their next clinic visit before receiving the next 30-day supply. This process will continue for the full 90 days of study involvement, with a final visit 3 months later.
15755302|NCT04815187|Drug|Placebo|Each subject will be given a drug diary to record when they took the drug and any symptoms that they are experiencing, and will bring this diary and any unused pills to their next clinic visit before receiving the next 30-day supply. This process will continue for the full 90 days of study involvement, with a final visit 3 months later.
15755303|NCT04815174|Other|Standard of Care|(i) advanced clinical and biological monitoring system (ii) symptomatic treatment adapted to the patient's needs, such as antibiotic therapy, oxygen therapy and blood transfusion; (iii) dialysis or mechanical ventilation.
15755304|NCT04815161|Behavioral|Adherence|Adherence to medication using an electronic pillbox
15755305|NCT04815148|Drug|MH004 Ia(0.1%)|Spread approx. 1 g of MH004 topical cream to the upper thigh skin.
15755306|NCT04815148|Drug|MH004 Ia(0.3%)|Spread approx. 1 g of MH004 topical cream to the upper thigh skin.
15755307|NCT04815148|Drug|MH004 Ia(1%)|Spread approx. 1 g of MH004 topical cream to the upper thigh skin.
15755308|NCT04815148|Drug|MH004 Ia(3%)|Spread approx. 1 g of MH004 topical cream to the upper thigh skin.
15755309|NCT04815148|Drug|MH004 Ib-1(0.1%)|Spread approx. 0.5 g of MH004 topical cream to the area of Target AD Lesions.
15755310|NCT04815148|Drug|MH004 Ib-1(0.3%)|Spread approx. 0.5 g of MH004 topical cream to the area of Target AD Lesions.
15755311|NCT04815148|Drug|MH004 Ib-1(1%)|Spread approx. 0.5 g of MH004 topical cream to the area of Target AD Lesions.
15755312|NCT04815148|Drug|MH004 Ib-2(0.3%)|Spread approx. 0.5 g of MH004 topical cream to the Target Joint.
15755313|NCT04815148|Drug|MH004 Ib-2(1%)|Spread approx. 0.5 g of MH004 topical cream to the Target Joint.
15755314|NCT04815148|Drug|MH004 Ib-2(3%)|Spread approx. 0.5 g of MH004 topical cream to the Target Joint.
15755315|NCT04815135|Other|Observational study|Observational study, the study did not involve any interventions
15755316|NCT04815122|Radiation|SPECT TRODAT-1|The Single-photon Emission Tomography (SPECT) TRODAT-1 will be performed after the voluntary rest in a dark and silent room for 30 minutes, to eliminate possible influences from external stimuli; the radiopharmaceutical [99mTC] -TRODAT-1 will be injected through the venous access previously established, 4 hours after the injection of the radiopharmaceutical, the acquisition of cerebral SPECT will be performed in the two groups of obese women, with and without COMT Val158Met polymorphism. The images will be acquired on Philips BrightView XCT equipment, equipped with a double detector.
15755317|NCT04815109|Other|Encephalography measurement|Encephalography measurement and partially aggravated sedation.
15755318|NCT04815096|Drug|[18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine)|[18F]F-AraG is a radiolabeled high affinity substrate for deoxyguanosine kinase (dGK) and a low affinity substrate for deoxycytidine kinase (dCK), which are over-expressed in activated T cells.
15755319|NCT04815083|Drug|Aminolevulinic Acid Hydrochloride|PD G 506 A for oral solution (aminolevulinic acid [ALA] hydrochloride [HCl] granules for oral solution) is administered as a single dose (20 mg/kg body weight) approximately 3 hours (min 2 hours, max 4 hours) prior to anesthesia.
15755320|NCT04815083|Device|Eagle V1.2 Imaging System|Fluorescence imaging camera and associated accessories used to view and capture fluorescence and white light images and videos of the surgical cavity and excised tissue specimens during the surgical procedure.
15755321|NCT04815083|Drug|Placebo|Oral placebo is administered as a single dose approximately 3 hours (min 2 hours, max 4 hours) prior to anesthesia.
15755322|NCT04815070|Procedure|Ultrasonic measurement of antral area|"Ultrasound exam is done before the induction of spinal anesthesia. Three consecutive measurements of the anteroposterior (AP) and cranio-caudal (CC) diameters are performed.
~The cross-sectional area (CSA) of antrum is shown by the following formula: CSA = AP x CC x ㅠ/4.
~Antral area will correspond to the average of the three measures."
15755323|NCT04815057|Behavioral|Wellness Education|The wellness education given to fifth grade students and the quality of life, its effect on physical activity status
15755324|NCT04815044|Other|Pregnancy|Experiences from being pregnant when having a history of eating disorder
15755325|NCT04815044|Other|Post-Partum|Experiences from the post-partum period when having a history of eating disorder
15755327|NCT04815005|Other|Demographics, diagnosis type, genotype, lipid profile, treatment allocation, country of residence.|Differences in diagnosis, genotype, lipid profile treatment allocation among HoFH patients worldwide.
15755328|NCT04814992|Behavioral|Computer-Assisted Preoperative CBT Intervention (PAINTrainer)|Subjects will be asked to complete eight (8) 30- to 45-minute educational sessions during the 4 weeks prior to your surgery. In addition to the computer based training sessions, there is a motivational interviewing component that requires subjects to meet with a member of the study team weekly for a total of four (4) 30- to 45-minute meetings to help manage opioid medication use. It is expected that subject participation in this arm of the study will be a total of 12 hours over the course of the entire study.
15755349|NCT04814797|Other|Capnography data included in Lung Clearance Index measurement|Capnography data included in Lung Clearance Index measurement (a pulmonary function test included in routinely yearly follow-up of cystic fibrosis children) will be collected and analyzed
15755471|NCT04813705|Radiation|Reduced dose|The patients with CMR and more than 70% PMR at 25th fraction will receive reduced-dose radiotherapy for 30 fractions.
15755329|NCT04814979|Device|Low-intensity pulsed ultrasound (LIPUS)|Low-intensity pulsed ultrasound (LIPUS) consists of frequencies usually ranging from 0.75- 1.5 MHz at intensities <100mW/cm² (usually about 30mW/cm²) and usually pulsed at 1:4. The transducer head is strapped or otherwise held in place and remains stationary for treatment periods in the region of 20 minutes. Again, US medium is used for efficient sound transfer to deeper tissues. This modality was approved by the FDA in the United States in 1994 for the accelerated healing of fresh fractures and then approved by the same body in 2000 for the treatment of established non-union fractures. The studies presented to the FDA demonstrated that LIPUS had a positive effect during all three main stages of fracture healing, i.e. inflammatory, reparative and remodelling by enhancing angiogenesis, chondrogenesis and osteogenesis.
15755330|NCT04814979|Other|Routine physical therapy|"Gentle hamstrings stretching for 15 seconds 3 times a day. Flexibility of these muscle reduces stress to the lumbar region thus enhances the spino-pelvic rhythm (lumbar motion/pelvic motion). Strengthening of abdominal muscles (transversus abdominis and internal oblique). Training of these stability muscles in the lumbar spine provides a solid foundation for the individuals to integrate them into their functional movement patterns. Exercises focusing on these muscles have been shown to significantly decrease pain and disability in people with spondylolysis. Each exercise will be performed as 3 sets of 10 repetitions on alternate days."
15755331|NCT04814953|Other|questionnaires|EQ-5D-5L questionnaire questioning their overall health on five dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). In addition patients will have to fill in the generic 15D questioning 15 specific dimensions on 5 levels as well as the BaSQoL, which is a disease specific questionnaire for patients with KC. The Time-trade off task is the final question.
15755333|NCT04814927|Drug|Copper IUD|Participants randomized to Copper IUD will receive Paragard IUD at Visit 2.
15755334|NCT04814927|Drug|Etonogestrel implant|Participants randomized to ETG implant will receive the implant at Visit 2.
15755335|NCT04814927|Drug|Levonorgestrel IUS|Participants randomized to LNG intrauterine system will receive the IUS at Visit 2.
15755336|NCT04814927|Drug|DMPA Sub-cutaneous|Participants randomized to DMPA SC will receive the injection at Visit 2.
15755337|NCT04814914|Other|KB109 + Self Supportive Care|KB109 is a novel glycan
15755338|NCT04814914|Other|Self Supportive Care (SSC) Alone|Self Supportive Care (SSC) Alone
15755339|NCT04814901|Procedure|Curing small and medium sized oronasal fistula|"Flap will be marked medial to the duct, which limits posterior extent of flap. Anterior flap marking starts 1cm posterior to oral commissure.
~Width of flap was kept to about 2-2.5cm.
~An initial incision will be made 1cm posterior to oral commissure.
~Incision will be deepened through buccal mucosa, submucosa, & underlying muscles into layer of buccal fat.
~Flap will be dissected in a retrograde or antegrade manner depending on fistula site, maintaining vessels in a central position in the flap.
~Once completely raised, flap inserted & sutured in place while donor site be closed primarily with 4-0 polyglactin (Vicryl) interrupted sutures.
~Patient's comparator group will be treated by raising a palatal pedicled flap.
~Flap will be outlined extending from palatal mucosa against permanent 2nd molar till permanent canine anteriorly.
~It is rotated towards oronasal fistula & secured in place using 4 -0 Vicryl interrupted sutures."
15755340|NCT04814888|Other|intubation with a cuffed ETT by a printed 3D airway model|Two anaesthesiologists unaware of patient's demographic data such as patient's height, weight, and age predicted and recorded ETT size by inserting various sized cuffed-ETTs (MallinckrodtTM Hi-Lo tracheal tube, Covidien, Ireland) to a printed 3D airway model. If the diameter of trachea undersized, air leak around ETT can occur. In that case, we can use that ETT after inflating the pilot balloon with small amount of air. Standard monitoring (non-invasive blood pressure measurement, electrocardiogram, and pulse oximetry) was applied to pediatric patients in the operating room and general anesthesia was induced with ketamine 1 mg/kg and rocuronium 0.6 mg/kg and maintained with sevoflurane. After intubation with a cuffed ETT by a printed 3D airway model was finished, an air leak test was performed by one of three anaesthesiologists dedicated to pediatric cardiac anesthesia.
15755341|NCT04814875|Drug|ATX-101 + Carboplatin + Pegylated liposomal doxorubicin (ACD)|"Pegylated liposomal doxorubicin (30 mg/m²) will be administered intravenously on Day 1 of each 28-day cycle; carboplatin (AUC5) will be administered intravenously on Day 1 of each cycle.
~ATX-101 will be administered intravenously on Day 2 of each cycle in three escalation cohorts: 20, 30, and 45 mg/m² according to a 3+3 design."
15755343|NCT04814836|Procedure|Total-etch mode with 35% phosphoric acid (K-ETCHANT) (TE-A group)|35% phosphoric acid was applied to enamel and dentin for 10 s, washed and dried for 5 s. The universal adhesive, Clearfil Universal Bond Quick (CBQ) was applied to enamel and dentin surfaces with a single-use applicator, then gently air-dried for 5 s without waiting, and light-cured for 10 s.
15755344|NCT04814836|Procedure|Selective-etch mode with 35% phosphoric acid (K-ETCHANT) (SE-A group)|35% phosphoric acid was used only on enamel for 10 s, then washed and dried for 5 seconds. Subsequently, the adhesive was applied in a similar manner to the TE-A group.
15755345|NCT04814836|Procedure|Total-etch mode with Er, Cr: YSGG laser (Waterlase MD) (TE-L group)|the enamel margin and dentin surfaces of lesions were irradiated with an Er,Cr:YSGG laser (2780 nm, Waterlase MD, BioLase Technology, Inc., San Clemente, CA). Then the adhesive was applied in a similar manner to the TE-A group.
15755346|NCT04814836|Procedure|Selective-etch mode with Er, Cr: YSGG laser (Waterlase MD) (SE-L group).|The laser system was applied in the same way as described in the TE-L group only on enamel surface. Subsequently, the adhesive was applied in the same way as described in the TE-A group.
15755347|NCT04814836|Procedure|Self-etch mode Clearfil Universal Bond Quick (Kuraray, Japan) (SE group)|Universal adhesive system (CBQ) was applied to enamel and dentin surfaces without any previous etching. Then gently air-dried for 5 s without waiting, and light-cured for 10 s.
15755348|NCT04814823|Device|Pulse oximeter|OLV-4202 pulse oximeter (SW version: 01-11)
15755376|NCT04814524|Device|Fitbit|Wear Fitbit
15755377|NCT04814524|Other|Questionnaire Administration|Ancillary studies
15755378|NCT04814524|Device|Virtual Reality Device|Use VR
15755350|NCT04814784|Radiation|Neoadjuvent radiotherapy either short or long course chemoradiation in treatment of locally advanced cancer rectum|Study the effect of neoadjuvent radiotherapy in treatment of locally advanced cancer rectum e higher possiblity of preservation of anal sphincter and decreased rate of locoregional recurrence compared to surgery alone
15755351|NCT04814771|Drug|[14C] TS-142|Subjects received single dose of 7.5 mg of TS-142 containing 20 kBq [14C]TS-142 as an oral solution
15755352|NCT04814758|Diagnostic Test|MRI DWI sequence (ADC values)|Initially and after pre-operative chemotherapy To evaluate the differences in ADC values according to the malignancy degree of nephroblastoma in children
15755353|NCT04814745|Drug|intrathecal infusion|morphine 150 mcg will be used by intrathecal administration
15755354|NCT04814745|Drug|Intravenous Infusion|tramadol administration
15755355|NCT04814745|Drug|Ropivacaine injection|bilateral transversus abdominis plane block by using ropivacaine 80 mg
15755356|NCT04814732|Drug|Surufatinib|HMP-012
15755357|NCT04814719|Drug|Pentosan Polysulphate Sodium|Subcutaneous Injection (100mg/ml)
15755358|NCT04814719|Drug|Placebo (Sodium Chloride Injection, 0.9%)|Placebo to match PPS
15755359|NCT04814706|Dietary Supplement|Carbohydrate drinking|Administration of carbohydrate fluid
15755360|NCT04814693|Device|EndoRotor® System (Interscope, Inc., Northbridge, MA USA),|The EndoRotor System is intended for use in endoscopic procedures to resect and remove necrotic debris during DEN for WON. DEN with the EndoRotor System (study device) is considered to be standard of care therapy for patients with WON and not investigational.
15755361|NCT04814693|Procedure|Conventional endoscopic devices (according to standards of care)|Endoscopic devices used to perform conventional DEN will be chosen according to standard of care and Investigator preference.
15755362|NCT04814654|Behavioral|CHALO! 2.0|"The components of the intervention are:
~Contents of digital-media (sent twice/week for 12 weeks) on the following topics: HIV testing, prevention, treatment, linkage-to-care; Personalized digital coupon for free testing; Webpage listing testing/ care sites; access to online outreach workers."
15755363|NCT04814654|Behavioral|Attention-matched control (AMC)|"The components of the intervention are:
~Contents of digital-media (sent twice/week for 12 weeks) only related to general health information; Personalized digital coupon for free testing; Webpage listing testing/ care sites; access to online outreach workers."
15755364|NCT04814654|Behavioral|Digital coupon only (DCO)|"The components of the intervention are:
~Digital coupon for free HIV testing; Webpage listing testing/ care sites; access to online outreach workers."
15755365|NCT04814641|Biological|hypophosphatemia occurrence in infants with severe bronchiolitis admitted in a pediatric intensive care unit|Serum phosphorus level < 1.55 mmol/L at any time between admission and the 5th day.
15755370|NCT04814615|Drug|89Zr-daratumumab PET/CT|CD38-targeting imaging
15755371|NCT04814602|Drug|Proglumide|CCK receptor antagonist
15755372|NCT04814589|Drug|ezetimibe tablets|The subjects randomly received single oral administration of ezetimibe tablets 10 mg.
15755373|NCT04814589|Drug|ezetimibe tablets(Ezetrol ®)|The subjects randomly received single oral administration of ezetimibe tablets 10 mg.
15755374|NCT04814576|Behavioral|Collaborative cares|The intervention consists of the co-design and implementation of therapeutic activities by the nurse and the mental health day hospital users following a collaborative care model. For this purpose, the participatory action research (PAR) method will be used and semi-structured interviews and focus groups will be used as data collection techniques.
15755375|NCT04814537|Drug|Bupivacaine Hydrochloride|Local Anesthetic Agent
15755379|NCT04814511|Drug|InfectoScab 5 % Creme|InfectoScab 5 % Creme is the already approved standard therapeutic agent, containing the active ingredient permethrin in 5 % concentration. In this study, it is used for topical treatment in the first treatment cycle (standard therapy) as well as in the second treatment cycle (escalation therapy).
15755380|NCT04814511|Drug|Permethrin 10 % Creme|Permethrin 10 % Creme also contains permethrin as the active ingredient, but in 10 % concentration. Permethrin 10 % creme is used exclusively for topical treatment in the second therapy cycle (escalation therapy).
15755381|NCT04814511|Drug|Driponin 3 mg Tabletten|Driponin 3 mg Tabletten are approved for the treatment of scabies, containing ivermectin as the active ingredient. Driponin is used as a supplementary, peroral add-on combination treatment in addition to topical permethrin therapy and is used exclusively in the second treatment cycle (escalation therapy).
15755382|NCT04814498|Drug|Geneva Cocktail|Fixed sequence use of drug cocktail
15755383|NCT04814498|Drug|BLD-0409|Fixed sequence use of active product
15755384|NCT04814485|Drug|SHR-1020+albumin-bound paclitaxel|SHR-1020 combined with albumin-bound paclitaxel for advanced pancreatic cancer
15755386|NCT04814459|Other|HOP-UP-PT Program|Interventions provided to EG participants included; (1) the Otago Exercise Program (OEP) which is a well-established exercise program with evidence that it reduces falls among community-dwelling older adults, (2) motivational interviewing (MI) to optimize positive health behaviors, and (3) home and environmental modification recommendations aimed at safety. Participants were provided with and educated on the use of a wrist-worn activity tracker and an automated BP monitor unit. Finally, when follow up items were identified (e.g., orthostatic hypotension, community exercise classes), these referrals were made and documented.
15755387|NCT04814446|Biological|Vaccination|Intramuscular injections of 0,5 ml will be administered at M0, M2 and M6
15755388|NCT04814433|Drug|Tranexamic acid|"FDA-approved usage for intravenous tranexamic acid (TXA) is for heavy menstrual bleeding and short-term prevention in patients with hemophilia.
~Total dose of 500 mg (20 mL) total will be given."
15755389|NCT04814433|Drug|Aminocaproic acid|"FDA notes that aminocaproic acid is useful in enhancing hemostasis when fibrinolysis contributes to bleeding. Aminocaproic acid inhibits both the action of plasminogen activators and to a lesser degree, plasmin activity. The fibrinolysis-inhibitory effects of aminocaproic acid appear to be exerted principally via inhibition of plasminogen activators and to a lesser degree through antiplasmin activity. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
~Total of 1000 mg total will be given."
15755390|NCT04814433|Drug|Recombinant Human Thrombin|"Topical thrombin is FDA approved as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques is not sufficient.
~Recombinant human thrombin is available as 5000-unit and 20,000-unit vials of sterile recombinant topical thrombin lyophilized powder for solution. When reconstituted as directed, the final solution contains 1000 units/mL.
~For topical application, a total of 10000 units per open surgical study arm involving use of Thrombin will be given"
15755391|NCT04814433|Drug|Lidocaine Hydrochloride with Epinephrine|"Topical lidocaine product is FDA approved as an amide local anesthetic in any indication for relief of pain associated with superficial minor surgery and as an adjunct for local infiltration anesthesia. It is frequently used as a standard local anesthetic for surgical procedures.
~Each mL contains lidocaine hydrochloride and epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid as a stabilizer.
~Total of 5 mLs per open surgical study arm involving lidocaine hydrochloride and epinephrine will be given"
15755392|NCT04814433|Drug|Bupivacaine Hydrochloride with Epinephrine|"Topical bupivacaine is FDA approved as indicated for the production of local anesthesia for procedures by infiltration injection. It is frequently used as a standard local anesthetic for surgical procedures.
~Each mL contains bupivacaine hydrochloride and 0.005 mg epinephrine, with 0.5 mg sodium metabisulfite as an antioxidant and 0.2 mg citric acid (anhydrous) as stabilizer.
~Total of 5 mLs per open surgical study arm involving Bupivacaine Hydrochloride with Epinephrine will be given"
15755393|NCT04814420|Device|Delayed enhancement magnetic resonance imaging (DE-MRI)|The patient will be injected with late gadolinium enhancement (0.01 mmol/kg standard dosage), which is a contrast agent used in clinical practice in MRI imaging studies. The contrast agent is used to enhance specific regions/tissues on MRI and, in this study, will allow the investigators to identify fibrotic tissue within the heart. The patient then undergoes the MRI sequence, which lasts approximately 20-25 minutes. Images will be reviewed for quality by trained technicians. This will be repeated after 6 months.
15755394|NCT04814407|Diagnostic Test|Blood-derived DNA methylation detection|Up to 20 ml of blood will be collected from each subject, and the blood specimen will be processed to isolate plasma cell-free DNA and immune-derived cells (circulating T cells). Circulating methylated tumor/immune signature will then be identified.
15755396|NCT04814381|Drug|Ketamine + Magnesium sulfate (drug combination)|A single infusion will be performed over 2 hours with 90 days follow-up.
15755400|NCT04814355|Drug|Celecoxib 400 mg|Patients will receive 400 mg/day of celecoxib for 8 weeks.
15755401|NCT04814342|Device|Pulse oximeter|OLV-4202 pulse oximeter (SW version: 01-11)
15755402|NCT04814329|Other|genetic characteristic|the underlying genetic characteristics that prodicting response
15755403|NCT04814316|Diagnostic Test|Blood and urine specimens|"Blood and urine samples will be taken at baseline and at the end of the second month for study group and only at baseline for control group.
~For this purpose, 5 ml of blood samples will be taken to plain blood tubes for evaluation of calcium, magnesium, alkaline phosphatase, parathormone, 25-OH vitamin D and osteocalcin quantities. And 3 ml of urine for calcium, creatinine, deoxypyridinoline, C-terminal telopeptides type-1 collagen and N- terminal telopeptides type-1 collagen."
15755467|NCT04813757|Other|manual therapy|on each treatment session both group will receive 15 minutes of manual therapy which will include: massage,3-4 trigger point treatment posterior capsule stretch and mobilization with movement
15755468|NCT04813744|Procedure|Atraumatic restorative treatment|
15755404|NCT04814303|Procedure|Intrathecal morphine|After applying standard monitoring of pulse oximetry, ECG, NIBP; while the patient in the sitting position following complete sterile aseptic condition after sterilization bovine bethidine spinal anesthesia will be induced with heavy bupivacaine 0.5% 12.5-15 mg (2.5-3 mL) at L3-4 or L4-5 inter-vertebral levels using a 25- gauge Whitacre needle. Intrathecal morphine 150 μg will be added to patients of both groups. Supplemental oxygen will be administered via a simple face mask.
15755405|NCT04814303|Procedure|Adductor Canal block|The block will be performed in the mid adductor canal to block both the saphenous and the nerve to vastus medialis. After skin infiltration with 1 to 2 mL of 2% lidocaine, an 80-mm, 22-gauge, short-bevel echogenic needle is advanced in plane with the ultrasound beam in an anterior-to-posterior direction until the tip is located within the adductor canal deep to the vastoadductor membrane. After negative aspiration, 1-2 mL of local anesthetic is injected to confirm the proper injection plane. The study solution will be injected within the canal adjacent to the femoral artery. Patients in group 1 received 30 mL of 0.25% bupivacaine with 1:400,000 epinephrine and 4 mg dexamethasone.
15755406|NCT04814303|Procedure|Peri-articular Infilteration|the surgeon will perform the PAI intra-operatively; 150 mL of 0.25% bupivacaine with 1:400,000 epinephrine, 30 mg of ketorolac, and 8 mg dexamethasone. Half of the solution will be administered into the posterior capsule and posterior soft tissues of the knee under direct vision after osteotomy but before insertion of the implants. The remaining half of the solution will be administered into the anterior soft tissues after placement of the implants and before skin closure. All local infiltration will be carried out while a thigh tourniquet (used to limit surgical bleeding) was inflated at a pressure of 300 to 350 mm Hg.
15755407|NCT04814290|Other|health-related quality of life (HRQoL) (36-item short-form health survey, version 1 [SF-36]).|health-related quality of life (HRQoL) (36-item short-form health survey, version 1 [SF-36]).
15755409|NCT04814251|Other|Observationnal cohort|data collection
15755410|NCT04814238|Procedure|Aortic Root Surgery|First time, isolated, minimally invasive (mini-sternotomy, RALT) aortic root or aorta surgery
15755411|NCT04814225|Other|Test Product 1|Pea Protein powder
15755412|NCT04814225|Other|Test Product 2|Pea & Oat Protein Powder
15755413|NCT04814225|Other|Test Product 3|Oat Protein Powder
15755414|NCT04814225|Other|Comparator|Whey Protein Isolate
15755415|NCT04814212|Device|Percutaneous coronary intervention using drug-coated balloon|SeQuent Please (BBraun) + tailored antithrombotic regimen: 1) Stable patients without OAC: perioperative SAPT (preferably) or perioperative DAPT followed by lifelong SAPT 2) Stable patients with OAC: perioperative SAPT (preferably) or perioperative DAPT 3) ACS patients without OAC: 1-month DAPT followed by lifelong SAPT 4) ACS patients with OAC: perioperative DAPT followed by 1-month SAPT
15755416|NCT04814212|Device|Percutaneous coronary intervention using drug-eluting stent|Biofreedom (Biosensors), Synergy (Boston Scientific), Ultimaster Tansei (Terumo) and Integrity Onyx (Medtronic) + tailored antithrombotic regimen: 1) Stable patients without OAC: 1-month DAPT followed by lifelong SAPT 2) Stable patients with OAC: perioperative DAPT followed by 12 months SAPT (ADP receptor blocker) 3) ACS patients without OAC: 3-month DAPT followed by lifelong SAPT 4) ACS patients with OAC: perioperative DAPT followed by 12 months SAPT (ADP receptor blocker)
15755417|NCT04814199|Other|Algorithm|Patients will have a printed algorithm to follow while they are in labour with an epidural for pain management.
15755418|NCT04814186|Drug|Tafamidis|61 mg, once daily, oral administration, for 12 months.
15755419|NCT04814173|Other|One-jaw mechanic total maxillary arch distalization|A group of patients in which participants will be undergo to the one-jaw mechanic for mini-implants anchored total-maxillary-arch-distalization (the mini-implants will be inserted in the maxillary arch between the roots of 2nd premolar and 1st molar and closer to the molar, then a force of 250 g will be applied from the TAD to a hook lateral to the laterals).
15755420|NCT04814173|Other|Two-jaw mechanic total maxillary arch distalization|A group of patients in which participants will be undergo to the tow-jaw mechanic for mini-implants anchored total-maxillary-arch-distalization (the mini-implants will be inserted in the mandibular arch between the 2nd premolar and 1st molar, then, a class II elastics 3/16 and 6.5oz will be use from the TAD to the hook of canines brackets).
15755421|NCT04814173|Other|en-mass retraction|A group of patients in which participants will be undergo to the en-mass retraction with first premolars extraction with mini-implants in the maxillary arch inserted between the 2nd premolar and 1st molar, then a force of 250 g will be applied from the TAD to a hook lateral to the laterals .
15755422|NCT04814160|Procedure|mixture of bioactive glass and autogenous bone graft|bone expansion was performed and autogenous bone mixed with bioactive glass was used to augment the intercortical bone defect after ridge splitting and simultaneous dental implants
15755423|NCT04814160|Procedure|autogenous bone graft|bone expansion was performed and autogenous bone alone was used to augment the intercortical bone defect after ridge splitting and simultaneous dental implants
15755424|NCT04814147|Procedure|Sleeve gastrectomy|Measure of NLRP3 inflammasome preoperative activation level by the expression of NLRP3, IL-1β, IL18 and caspase-1 mRNAs in subcutaneous and visceral adipose tissue. of the epiploon;
15755425|NCT04814134|Device|CPNS Therapy|Endovascular stimulation of the cardiac autonomic nerves in addition to standard of care
15755426|NCT04814134|Other|Standard of care|Available standard treatment
15755427|NCT04814121|Drug|Suxiao Jiuxin Pills|Suxiao Jiuxin Pills consists Rhizoma Ligustici (Chuan xiong) and Borneolum (Bing pian).
15755428|NCT04814121|Drug|The placebo of Suxiao Jiuxin Pills|The placebo of Suxiao Jiuxin Pills is similar to Suxiao Jiuxin Pills in appearance, smell, and taste.
15755429|NCT04814108|Drug|ZN-c3|ZN-c3 is an investigational drug.
15755430|NCT04814095|Behavioral|QOL|QOL assessments using the ESAS, CPC, EQ5D every 4-8 weeks +/- 2 weeks
15755431|NCT04814095|Diagnostic Test|CT imaging|CT radiographic imaging every 12 weeks +/- 2 weeks
15755432|NCT04814082|Device|MicroPort Evolution Medial-Pivot Knee System (Cruciate-substituting)|Medial Pivot Knee System
15755433|NCT04814082|Device|Stryker Triathlon Tritanium Knee System (Condylar Stabilizing)|Single Radius Design Total Knee System
15755434|NCT04814069|Drug|Tislelizumab|Tislelizumab 200mg q3w
15755469|NCT04813718|Dietary Supplement|Omni-Biotic Pro Vi 5|Pre- and probiotic
15755435|NCT04814056|Drug|Afatinib Dimaleate|Afatinib is the second-generation TKI drug, which can irreversibly bind to receptors of erbB family. Afatinib will be administered orally at a dose of 40 mg per time, Q.D. If a patient cannot tolerate a dose of 40mg due to adverse reactions, when the adverse reactions restore to level 1 (CTCAE 5.0) or below, the dosage could be adjusted to 30mg per day, Q.D.
15755436|NCT04814043|Drug|PD-1 inhibitor|systemic PD-1 antibody (Sintilimab) and lenvatinib plus transarterial chemobolization and FOLFOX-based chemotherapy infusion
15755437|NCT04814030|Drug|PD-1 inhibitor|Transarterial hepatic chemoembolization and FOLFOX-based infusion
15755438|NCT04814017|Procedure|Radial Shock-Wave Therapy|Radial shock-wave therapy was applied in 1.0-4.0 bar intensity, 10-15 hz frequency interval. 300-700 pulse for a trigger point, 1500-3000 pulse for a muscle. Intensity, frequency and pulse increased every session regularly beginning from minimal taking patients tolerance into consideration. Trigger points in the upper, middle and lower trapezius, supraspinatus, infraspinatus and levator scapula muscles were treated. Neck and upper back muscle static stretching exercises were teached to patients as home exercise program. The patients were asked to do each stretching exercise given as a home-based program every day, 3 times a day and 3 repetitions. The exercise program consisted of static neck lateral flexors stretching, shoulder posterior capsule stretching and apley stretching exercises. Exercise booklets were prepared and given to the patients.
15755439|NCT04814017|Procedure|Control|Neck and upper back muscle static stretching exercises were teached to patients as home exercise program. The patients were asked to do each stretching exercise given as a home-based program every day, 3 times a day and 3 repetitions. The exercise program consisted of static neck lateral flexors stretching, shoulder posterior capsule stretching and apley stretching exercises. Exercise booklets were prepared and given to the patients.
15755440|NCT04814004|Drug|hCD19.IL15.CAR-iNKT|Universal hCD19.IL15.CAR-iNKT cells by a single infusion intravenously will be given in escalating doses.
15755441|NCT04813991|Drug|Ibuprofen 600 mg|Ibuprofen 600 mg for breakthrough pain.
15755442|NCT04813991|Drug|OxyCODONE 5 Mg Oral Capsule|OxyCODONE 5 Mg Oral Capsule for breakthrough pain.
15755443|NCT04813978|Other|Music|For the interventional group, in addition to normal nursing care, patients will listen to instrumental relaxing music genre consist of pitch, rhythm and tone color for 30 minutes pre-operatively, using mp3 player and over-ear headphones to reduce outside interference, at a volume of the patient's preference.
15755444|NCT04813965|Other|Written information about potential chemotherapy-related cognitive symptoms without self-affirmation|
15755445|NCT04813965|Other|Written information about potential chemotherapy-related cognitive symptoms with self-affirmation|
15755446|NCT04813952|Drug|Sevoflurane inhalant product|The sevoflurane dose differed in both groups in relation to the fresh gas flow. Since the fresh gas flow is less in group M, the concentration of sevoflurane consumed by the patient at the end of the case will be less.
15755447|NCT04813939|Device|IB10 sphingotest® bio-ADM® apparatus (Sphingotec GmbH, Hennigsdorf, Germany)|Point of care assessment of bio-adrenomedullin concentration will be performed using the IB10 sphingotest® bio-ADM® apparatus (Sphingotec GmbH, Hennigsdorf, Germany) on the 1,3,5-day ICU stay in COVID-19 patients. The method used is a double monoclonal sandwich immunoassay to measure the concentration of C-terminal amidated, biologically active adrenomedullin (bio-ADM) in whole blood. Additional measurement of bio-ADM will be performed as standard monitoring in patients suspected of septic complications of the course of COVID-19.
15755448|NCT04813926|Drug|Riociguat (Adempas, BAY63-2521)|Follow clinical practice.
15755449|NCT04813913|Drug|Bevacizumab in combination with chemotherapy based on fluoropyrimidine IV|Enrollement of major patient with colorectal cancer of the adenocarcinoma type, stage IV, histologically confirmed, naive in antineoplastic treatment and eligible to start a systemic carcinological treatment comprising bevacizumab in combination with chemotherapy based on fluoropyrimidine IV. The main objective is to show that there is an increase in the stiffness of the carotid artery at 4 months in patients with stage IV colorectal cancer exposed to bevacizumab.
15755450|NCT04813900|Other|Lung ultrasound|Lung ultrasound in order to calculate lung ultrasound score
15755451|NCT04813887|Other|questionnaire|Self-questionnaire on skin diseases reported during pregnancy
15755452|NCT04813874|Drug|Nitrous Oxide|Nitrous Oxide Inhalational Agent
15755453|NCT04813874|Procedure|Neuraxial analgesia|Epidural Labor Analgesia Placement
15755454|NCT04813848|Procedure|Application of varnish fluoride desensitizing agent on buccal surfaces of exposed dentin|"Varnish fluoride is a single dose transparent varnish with 5 % sodium fluoride (22.600 ppm fluoride) and 5 % calcium fluoride.
~The application was performed according to the manufacturer's instructions. The varnish was applied on a clean and dry surface, then after 10-20 seconds to allow the fluoride varnish to be absorbed, was then dried with air."
15755455|NCT04813848|Procedure|Application of bonding agent desensitizing agent on buccal surfaces of exposed dentin|Bonding agent is a single dose dual curing universal adhesive and its application was performed according to the manufacturer's instruction for cases with hypersensitive tooth necks. The bonding was applied without etching, on a clean and dry surface. After 10 s any excess material was removed and then light cured for 30 s.
15755456|NCT04813822|Drug|Miconazole Nitrate 2% + Domiphen Bromide Low Dose|Dosage 1
15755457|NCT04813822|Drug|Miconazole Nitrate 2% + Domiphen Bromide High Dose|Dosage 2
15755458|NCT04813822|Drug|Miconazole Nitrate 2%|Active Comparator
15755459|NCT04813809|Device|BARRIER EasyWarm|Application of BARRIER EasyWarm for 10 hours. The treatment with the investigational device will be according to the instruction stated on the investigational device.
15755460|NCT04813796|Biological|mRNA-1283|Sterile liquid for injection
15755461|NCT04813796|Biological|mRNA-1273|Sterile liquid for injection
15755462|NCT04813796|Biological|Placebo|0.9% sodium chloride (normal saline) injection
15755463|NCT04813783|Other|Mucositis care training to be given in line with MASCC / ISOO 2019|Mucositis care training to be given in line with MASCC / ISOO 2019
15755464|NCT04813770|Behavioral|Theory-based messages|COVID-19 vaccination information structured to address vaccination necessity and concerns.
15755465|NCT04813770|Behavioral|General messages|General messages about the COVID-19 virus and the vaccination programme.
15755466|NCT04813757|Other|exercise|each group will perform 2 shoulder strength exercise at the therapy session and 3 exercise at home session-2 strength exercise and one stretching exercise. they will perform the exercises 5 times per week
15755472|NCT04813705|Radiation|Conventional dose|The patients who do not achieve CMR or 70% PMR at 25th fraction will receive conventional dose radiotherapy for 33 fractions.
15755473|NCT04813705|Drug|Chemotherapy|The patients with stage II will receive concurrent cisplatin during Intensity modulated radiotherapy (IMRT), and stage III-IVA patients will receive platinum based induction chemotherapy every 21 days for at least two cycles followed by concurrent cisplatin during IMRT.
15755474|NCT04813692|Procedure|Surgical repair|Surgical repair of post-infarction LVFWR or VSR
15755475|NCT04813692|Procedure|Percutaneous treatment|Percutaneous closure of post-infarction VSR (or treatment for LVFWR)
15755476|NCT04813692|Procedure|Mitral valve surgery|Mitral valve repair or replacement for post-infarction PMR
15755477|NCT04813679|Diagnostic Test|Bed side Ultrasound Sonography|Bed side Ultrasound in Neutropenic patients within 12 h from onset of any symptom such as fever and/or abdominal pain and/or diarreha
15755478|NCT04813666|Diagnostic Test|Urinary LAM ELISA:|
15755479|NCT04813653|Drug|cyclosporine in combination with carfilzomib and dexamethasone|patients will be treated with cyclosporine with dose titration based on repeated determinations of whole blood concentrations to achieve a target trough concentration of 250 ng/mL, in combination with carfilzomib plus dexamethasone.
15755480|NCT04813640|Device|Spectacles|Novel spectacles for myopia control
15755481|NCT04813627|Procedure|Regular blood sample collection for ctDNA assessment|Blood samples for in vitro testing of ctDNA status will be drawn at study visits every three months
15755482|NCT04813614|Device|STYLAGE M Lidocaine|Injection in the lips
15755483|NCT04813614|Device|Active control group|Injection in the lips
15755484|NCT04813601|Device|ATLAS 2030|The participant will attend the laboratory every week, two days a week. The therapy will consist of the use of the exoskeleton for rehabilitative purposes. At the end of each three-month period, each patient's data will be monitored.
15755485|NCT04813588|Other|Pantomiming|Pantomiming with fluency shaping techniques
15755486|NCT04813588|Other|Easy onset|Easy onset method with breathing exercises
15755487|NCT04813575|Other|Cryo lung biopsies|Bronchoscopic lung biopsy utilizing the cryo technique
15755488|NCT04813562|Biological|a middle-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 56|18-59 years,Three doses of middle-dose (20µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.
15755489|NCT04813562|Biological|a high-dose recombinant COVID-19 vaccine (CHO Cell) (18-59 years) at the schedule of day 0, 28, 56|18-59 years,Three doses of high-dose (40µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.
15755490|NCT04813562|Biological|a middle-dose recombinant COVID-19 vaccine (CHO Cell) (60-85 years) at the schedule of day 0, 28, 56|60-85 years,Three doses of middle-dose (20µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.
15755491|NCT04813562|Biological|a high-dose recombinant COVID-19 vaccine (CHO Cell) (60-85 years) at the schedule of day 0, 28, 56|60-85 years,Three doses of high-dose (40µg/0.5ml) recombinant COVID-19 vaccine (CHO Cell) at the schedule of day 0, 28, 56.
15755492|NCT04813562|Biological|a middle-dose placebo (18-59 years) at the schedule of day 0, 28, 56|18-59 years,Three doses of middle-dose (0.5ml) placebo at the schedule of day 0, 28, 56.
15755493|NCT04813562|Biological|a high-dose placebo (18-59 years) at the schedule of day 0, 28, 56|18-59 years,Three doses of high-dose (0.5ml) placebo at the schedule of day 0, 28, 56.
15755494|NCT04813562|Biological|a middle-dose placebo (60-85 years) at the schedule of day 0, 28, 56|60-85 years,Three doses of middle-dose (0.5ml) placebo at the schedule of day 0, 28, 56.
15755495|NCT04813562|Biological|a high-dose placebo (60-85 years) at the schedule of day 0, 28, 56|60-85 years,Three doses of high-dose (0.5ml) placebo at the schedule of day 0, 28, 56.
15755496|NCT04813536|Other|the Standard Shiftwork Index questionnaire|"Biographical information: This includes personal data (e.g., age, sex, marital status, and domestic situations), shift details (e.g., shift start and end times), organization of shiftwork, and general job satisfaction
~Sleep and fatigue: Measures the effect of shiftwork on perceived sleep quality and quantity and fatigue"
15755497|NCT04813536|Other|complete blood picture|5ml blood to estimate changes of total leucocytic count, Hemoglobin, eosinophilic, monocyte
15755498|NCT04813536|Other|lipid profile|5ml blood to estimate changes of plasma triglycerides, total cholesterol, low-density lipoprotein cholesterol (LDL-C), and HDL-C
15755499|NCT04813523|Drug|Pembrolizumab Injection [Keytruda]|Neoadjuvant period: pembrolizumab 200mg IV, Q3W with three cycles. Adjuvant period: pembrolizumab 200 mg IV, Q3W, up to one year, which should be performed within 3-6 weeks after surgery.
15755500|NCT04813510|Device|electroacupuncture treatment|"Participants in the treatment group underwent 60 minutes acupuncture (0.30mm×70mm) at Zusanli(ST36), Xiajuxu(ST39), Hegu(LI4), Neiguan(PC6) once a day for seven days. AfterDeqi, electroacupuncture stimulation apparatus(HANS G6805-2, Huayi Co, Shanghai, China) is connected with the density wave (2/100 Hz), width 0.25 ms, intensity of 1 ~ 30 mA (gradually increase to the patient's maximum tolerance) and maintained the end of treatment."
15755501|NCT04813510|Device|sham electroacupuncture treatment|"Participants in the sham electroacupuncture group received shallow needling (0.30mm×25mm) at nonacupoints (located 1 inch beside acupoints).. Specifically, the depth of needle insertion into nonacupoints is 3-5mm and avoided manual stimulation and no Deqi without actual current output, and retained the needle for the same time as treatment group"
15755502|NCT04813497|Diagnostic Test|Serology to determine SARS-CoV-2 infection|Each participant accept to have two blood tests on a dry tube of maximum 8 ml of whole blood
15755503|NCT04813484|Behavioral|Kickin it with the Gurlz|This multicomponent intervention includes a violence and gender affirmation screening tool, a peer delivered adaptation of the group-level Seeking Safety Program, and individual-level peer navigation sessions.
15755504|NCT04813471|Drug|Endothelial Protocol|Endothelial Protocol
15755505|NCT04813445|Drug|Xingnaojing injection|Xingnaojing injection (20 ml)+0.9% diluted sodium chloride injection 250ml, IV (in the vein), every 12 hours for 10 days.
15755543|NCT04813107|Drug|Tislelizumab alone|For patients assigned to this group (2), each patient will receive 3 cycles of treatments with a single dose of 200 mg tislelizumab administered on day 1 of each cycle, followed by RC.
15755659|NCT04812171|Procedure|non-surgical endodontic treatment|standard non-surgical endodontic treatment performed by endodontic specialist
15803768|NCT04420000|Behavioral|Mindfulness|Mindfulness based programme
15755506|NCT04813432|Diagnostic Test|Computed Tomography of the Abdomen|"Multi-phasic CT scan of the abdomen: 1 low dose unenhanced scan + 10 low dose arterial perfusion scans + 1 portal-venous phase scan + 1 delayed phase scan.
~Bolus-tracking threshold in abdominal aorta = 160 HU. Delay of first arterial scan 5 sec after bolus-tracking threshold has been reached; and then 1 scan every 3 sec until 35 sec after threshold.
~Contrast media (CM) protocol: fixed injection duration: 25 sec, body weight-adjusted CM volume: 750 mgI/kg bodyweight (max 80 kg women, 100kg men), Iomeron 400mgI/ml.
~Image-reconstruction: Motion-correction, noise-reduction and fusion of the best arterial time points to reconstruct one optimally timed early and one optimally timed late arterial phase."
15755507|NCT04813419|Device|1927nm thulium laser|The right face of subjects were treated with fractional 2940nm Er:YAG laser(MCL 31 Asclepion Laser Technologies, Germany), N25 mode. Energy was adjusted from 12 to 27J according to the severity of scarring. The left face of subjects were treated with fractional 1927nm thulium laser(Lavieen, korea). Parameters were set as stamp mode, a spot size of 5*5mm, a pulse time of 1000us, an energy intensity of 3645mJ/cm2 and a repetition of 1-3 times. All patients received 3 treatment sessions totally at an average interval of 4 to 6 weeks.
15755508|NCT04813419|Device|2940nm Er:YAG laser|The right face of subjects were treated with fractional 2940nm Er:YAG laser(MCL 31 Asclepion Laser Technologies, Germany), N25 mode. Energy was adjusted from 12 to 27J according to the severity of scarring. All patients received 3 treatment sessions totally at an average interval of 4 to 6 weeks.
15755509|NCT04813406|Drug|Anlotinib + Sintilimab|"Anlotinib: 1 capsule (10mg) once a day, d1-d14 per cycle, 3 weeks for a treatment cycle.
~Sintilimab: 200 mg/time, intravenous injection, every 3 weeks is one cycle."
15755510|NCT04813393|Other|Questionnaire Development|To evaluate psychometric the properties of the Compliance of Parents of Children with Cerebral Palsy to Home Program Assesment Questionnaire (CPHP-Q), a caregiver-report for adherence and frequency of home program implementation of parents of children with Cerebral Palsy.
15755511|NCT04813380|Other|Sublingual immunotherapy|Sublingual immunotherapy give to allergic rhinitis patients for treatment
15755512|NCT04813367|Procedure|Surgery of twisted fallopian tubes|Patients diagnosed with twisted fallopian tube go through surgery.
15755513|NCT04813354|Device|ELLIPTA|"ELLIPTA followed by BREEZHALER/ Preference Questionnaire version 1
~ELLIPTA followed by BREEZHALER/ Preference Questionnaire version 2
~BREEZHALER followed by ELLIPTA/ Preference Questionnaire version 1
~BREEZHALER followed by ELLIPTA/ Preference Questionnaire version 2"
15755514|NCT04813354|Device|BREEZHALER|"ELLIPTA followed by BREEZHALER/ Preference Questionnaire version 1
~ELLIPTA followed by BREEZHALER/ Preference Questionnaire version 2
~BREEZHALER followed by ELLIPTA/ Preference Questionnaire version 1
~BREEZHALER followed by ELLIPTA/ Preference Questionnaire version 2"
15755515|NCT04813341|Other|Pilates training|Bridging, roll up, one leg circle (both ways); single straight leg stretches; double leg stretches; side kick up and down; side kick circles. The participant will be instructed to perform 3-5 repetitions of these movements at the start, and to add two more repetitions for each movement every week until the end of the intervention.
15755516|NCT04813341|Other|Aerobic Training|"WALKING: 10 mint brisk walk excluding warm up and cool down in 5 days/ week STATIONARY CYCLE: for 10 mints, 5 days/ week
~SITTING EERCISES:
~Chest stretch: ask to hold for 5 seconds and perform 5 repetitions Upper body twist: ask to cross the arms against chest and hold for 5 seconds, perform 5 repetitions Hip marching: Ask the client to sit on chair with arm rest and lift each of her leg 5 times
~BALANCE EXERCISES:
~Sideways walking: ask to perform 10 steps on each way (side to side), 5 days/week.
~Heel to Toe walk: perform at least 5 steps and increase gradually in each repetition, 5days/ week Step up and down: Ask to step up and down on given surface, 5 repetitions on each leg, 5 days/ week."
15755517|NCT04813315|Other|Kendall exercise|consist of stretch of pectoralis major and neck extensor strengthening of deep neck flexors and scapular retractor
15755518|NCT04813315|Other|Gong's mobilization|it is combination of glide along the facet joint and concurrent movement of cervical spine
15755519|NCT04813302|Procedure|Coronally advanced flap and connective tissue graft|CAF+CTG treatment will be performed by starting with two vertical releasing incisions lateral to the teeth to be treated and split-full-split thickness flap will be raised beyond the MGJ. The periosteum will be cut, and a blunt dissection into the vestibular lining mucosa will be carried out to eliminate muscle tension so that the mucosal flap can be passively positioned above the level of CEJ on the tooth. The papillae adjacent to the involved teeth will be de-epithelialized. CTG of 1mm in thickness will be harvested from the posterior palate by means of disepithelization of a free gingival graft, cut to the exact size of the defect, and placed over the dehisced defect, sutured to the interdental papillae and subsequently covered with CAF. Sling sutures will be placed to stabilize the flap in a coronal position about 1-2 mm above the CEJ , followed by interrupted sutures to close the releasing incisions.
15755520|NCT04813276|Behavioral|Strong Together serious game|The Strong Together serious game program is an interactive, immersive education program in which participants quickly learn the behaviors of self-advocacy and the potential consequences of self-advocating or not. Participants receive weekly notifications for 12 weeks alerting them that a new serious game session is available and encourage them to complete one session per week.
15755521|NCT04813276|Behavioral|Enhanced Care as Usual|A self-advocacy patient brochure published by the National Coalition for Cancer Survivorship. This guide is not a part of usual care, but is freely available on the Internet.
15755522|NCT04813250|Other|ventilation mode setting|Ventilation strategies with 4 kinds of ventilator mode since weaning cardiopulmonary bypass (CPB), Four group were control EtCO2 between 35～45mmHg by adjusting respiratory rate, EIT Measurements were performed under supine position
15755523|NCT04813237|Other|n a|the participants are not subjected to any type of intervention
15755524|NCT04813224|Behavioral|TRAUMA CENTERED EMDR-BASED TREATMENT and TRAUMA-FOCUSED CBT-BASED TREATMENT|Psychological evidence-based intervention for the reduction of the impact of childhood sexual abuse.
15755541|NCT04813120|Behavioral|Traditional MT using a mirror box|During traditional MT, the participants will be seated in front of a mirror box placed at their mid-sagittal plane. The affected arm and hand of the participants will be placed inside the mirror box, and the non-affected arm and hand will be in front of the mirror. As similar to the UM-UT group, the participants will be instructed to watch the mirror reflection of the movements performed by the non-affected arm and hand carefully and to imagine that the movements were performed by the aﬀected arm and hand. In this group, the patient's affected arm and hand inside the mirror box will not need to move.
15755525|NCT04813211|Procedure|mobile artificial cervical vertebrae replacement|"Position: The patient is in a supine position with the neck hyperextended, ensuring his/her neck and shoulders in a stable and neutral position before surgery and the cervical spine in a physiological curvature position.
~Anesthesia: General anesthesia via oral tracheal intubation.
~Surgical approach: Anterior cervical spine approach through the space between the visceral sheath and the vascular sheath.
~Surgical method: Two intervertebral discs with adjacent lesions and part of the vertebral body between them will be removed. A curette is used to carefully strike off the annulus fibrosus and cartilage on the surface of the adjacent upper and lower endplates. Intraoperatively, the midlines of the segment and the vertebra to be replaced should be mapped out. When decompression, the midline for decompression should not be deviated from the planned midlines."
15755526|NCT04813211|Procedure|anterior cervical corpectomy and fusion|"Position: The patient is in a supine position with the neck hyperextended.
~Anesthesia: General anesthesia via oral tracheal intubation.
~Surgical approach: Anterior cervical spine approach through the space between the visceral sheath and the vascular sheath.
~Surgical method: Two intervertebral discs with adjacent lesions and part of the vertebrae between them will be removed. A curette will be used to carefully strike off the annulus fibrosus and cartilage on the surface of the adjacent upper and lower endplates. The removed vertebral bone will be trimmed into cancellous bone particles and filled in a cervical titanium cage with an appropriate size. The titanium cage will be implanted into the vertebral space, and fixed with adjacent vertebrae using anterior cervical titanium plates and screws."
15755527|NCT04813198|Behavioral|TIPSTART|TIPSTART is a multimodal, cognitive behavior-based therapy integrating peer-sharing, technology, aerobic and resistance training.
15755528|NCT04813185|Behavioral|Bridging the Gap|"Bridging the Gap Bridging the Gap is a hybrid model for violence prevention which integrates a hospital-based brief violence intervention (BVI) delivered to the patient while in hospital with a wrap-around community case management prevention strategy.
~Firearm Counseling Program The firearm counseling program was developed to be administered in the hospital alongside the 6-step intervention program, as well as in the patient's home after hospital discharge. The firearm safety counseling program includes 3 components aimed at understanding patient risk, reducing firearm-related violence risk-factors, and helping patients increase firearm safety practices."
15755529|NCT04813172|Behavioral|Symptom Assessment|"Examine the symptomatology of head and neck cancer patients undergoing treatment that includes radiation by completing the M.D. Anderson Symptom Inventory for Head and Neck Cancer (MDASI-HN), the Brief Pain Index (BPI)and the Functional Assessment of Cancer Therapy for Head and Neck Cancer (FACT-H&N). They will also be asked to complete the Hearing Handicap Inventory for Adults - Screening (HHIA-S) and the Tinnitus Handicap Inventory - Screening (THI-S) as well as the Flourishing Measure.
~Each patient enrolled will be followed by a nurse and speech-language pathologist, twice a week, throughout their treatment (from start until 3-month post completion) All assessments are collected on a secure Ipad through REDcap database. If any significant changes occur, within 2 points from their last assessment, the nurse will notify the oncology physician and provide plan of care to avoid emergency room or hospital visit."
15755530|NCT04813159|Device|Remote Ischaemic Conditioning (RIC)|The RIC protocol will comprise inflation of the automated RIC device to 20 mmHg above systolic blood pressure for 5 minutes and deflation for a further 5 minutes, a cycle which will be completed four times in total. The RIC protocol will be repeated daily for the next 2 days.
15755531|NCT04813159|Device|Sham-control|The sham protocol will comprise low-pressure inflation to 20 mmHg for 5 minutes and deflation for a further 5 minutes, a cycle which will be completed four times in total by a visually identical pneumatic cuff used in the active arm. The sham control protocol will be repeated daily for the next 2 days.
15755532|NCT04813146|Other|SLP|Synchronization of dietary intake with circadian rhythm of the body
15755533|NCT04813146|Other|SLP along with Physiotherapy|Synchronization of dietary intake along with Physiotherapy (aerobic, flexibility, resistance and balance exercises)
15755534|NCT04813146|Other|Physiotherapy|Physiotherapy given only (aerobic, flexibility, resistance and balance exercises)
15755535|NCT04813133|Other|Synchronized Lifestyle Modification Program|Synchronization of dietary intake with circadian rhythm of the body.
15755536|NCT04813133|Other|Synchronized Lifestyle Modification Program and Physiotherapy|Synchronization of dietary intake with circadian rhythm of the body along with Physiotherapy ( Aerobics, flexibility, resistance and balance exercises.)
15755537|NCT04813133|Other|Physiotherapy|Only Physiotherapy training which includes ( Aerobics, flexibility, resistance and balance exercises.)
15755538|NCT04813120|Behavioral|Uni-MVF condition and unimanual training mode using the new MT system (UM-UT)|For the UM-UT group, the participants will be seated in front of the new MT system, and will be instructed to watch the real-time image reflection of movements of the non-affected arm and hand on the screen carefully. At the same time, the patients will need to imagine that the movements were performed by their affected arm and hand. In this group, only the non-affected arm and hand will need to perform the movements, but the affected one will not need to move.
15755539|NCT04813120|Behavioral|Uni-MVF condition and bimanual training mode using the new MT system (UM-BT)|During the UM-BT, as similar as the first group (UM-UT), the participants will be also seated in front of the new MT system, and be instructed to watch the real-time image reflection of the non-affected arm and hand's movements on the screen carefully and imagine that the movements were performed by the affected arm. However, in this UM-BT group, the bilateral training mode is emphasized, and thus both arms and hands will need to move. That is, during therapy, the patient's affected arm and hand will be required to move at his/her best motor ability with the non-affected arm and hand at the same time.
15755540|NCT04813120|Behavioral|Bi-MVF condition and bimanual training mode using the new MT system (BM-BT)|For the BM-BT group, the participants will be seated in front of this new MT system, and be instructed to observe the real-time image reflection of the non-affected arm and hand's movements transformed and superimposed on both arms and hands (i.e., bi-MVF), and to imagine that the movements were performed by both arms and hands. In this group, bi-MVF and bilateral training mode are emphasized, and thus both arms and hands will also need to move. The patient's affected arm and hand will be required to move as could as possible simultaneously.
15755542|NCT04813107|Drug|APL-1202 in combination with tislelizumab|For those assigned to this group (1), each patient will receive 3 cycles of treatment prior to RC and each cycle is 3 weeks. On day 1 of each cycle, a single dose of 200 mg tislelizumab will be administered intravenously. APL-1202 will be administered orally TID daily for 3 weeks at the RP2D defined from Phase I.
15755544|NCT04813094|Other|Internet-Based integrated-management Program|The Internet-based integrated management Program system have five domains that included patient's information collection, AF knowledge area, instructions on anticoagulation medicine, self-monitoring of symptom area, and professional consultation. Everyone have their own area to ensure the privacy of participants. The research nurse has sent messages every day to care about the participant's condition. In this area, when the participant have an emergency, it not only provided textual information, but also provided telephone coaching.
15755545|NCT04813094|Other|Control group|Patients in the control group will receive standard nurse consultations and three-time telephone coaching.
15755546|NCT04813081|Procedure|Free Gingival Graft|In the recipient area, a half-thickness flap with two vertical incision widths was removed with a horizontal incision with 15C blades from the mucogingival junction. The recipient site was determined such that one or two teeth or one tooth extends into the mesial and distal regions of the tooth. Muscle attachments were dissected and FGG was placed on recipient bed and non-resorbable monofilament sutures were used for fixing the four corners of the graft.
15755547|NCT04813068|Other|Semi-structured interview|Semi-structured interview to identify attitudes to re-irradiation in lung cancer
15755548|NCT04813055|Procedure|Therapeutic EUS|"EUS-guided collection drainage (transgastric or transduodenal, performed by Lumen Apposing Metal Stents or double pigtail stents) and eventual endoscopic necrosectomy
~EUS-guided biliary drainage (either of the extrahepatic or intrahepatic biliary tree / transduodenal or transgastric / either as access for subsequent rendez-vous or transpapillary stenting OR for transparietal stenting by metal or plastic stents).
~EUS-guided gallbladder drainage via Lumen Apposing Metal Stents and eventual subsequent EUS-based cholecystolithotomy
~EUS-guided gastro-jejunostomy through Lumen Apposing Metal Stents
~EUS-directed ERCP in post-surgical anatomy (by gastro-gastrostomy or entero-enterostomy performed through Lumen Apposing Metal Stents)
~EUS-guided pancreatic duct drainage"
15755549|NCT04813055|Procedure|Percutaneous Procedures|Procedures involving a percutaneous access to a target region (fluid collection, gallbladder, biliary tree)
15755550|NCT04813055|Procedure|Surgical Interventions|Surgical interventions to obtain a drainage (e.g. surgical necrosectomy, pancreatico-gastrostomy) or the bypass of a stricture (hepatico-jejunostomy or gastro-jejunostomy)
15755551|NCT04813055|Procedure|non-EUS-based endoscopic procedures|Other endoscopic procedures not involving EUS (enteral stenting, Enteroscopy-assisted ERCP)
15755552|NCT04813042|Behavioral|Working Out Dads|"The WOD is a manualised group intervention underpinned by solution-focused therapy and social cognitive theories. Psychoeducation about the transition to fatherhood and its potential impacts on wellbeing and family relationships is provided. Fathers are encouraged to share practical ideas for managing stress, revisit previous strategies, validate what they are doing well, and explore solutions.
~The group discussion is followed by a structured group fitness session provided by a personal trainer. This session focuses on body weight exercises, cardio-based activities, stretching, mobility and incidental activity.
~Fathers in the WOD study arm receive 10 weeks of encouraging text messages - one each week during the intervention, and four in the weeks after. These will be sent via the WhatsApp group created for each WOD group. These text messages and the WhatsApp group are designed to facilitate fathers' active engagement with the intervention, and to maintain contact with each other."
15755553|NCT04813042|Behavioral|Usual care|The Usual Care arm, also known as 'Talking about being dad' comprises a telephone consultation with a qualified mental health professional. Topics including in this consultation include: (a) discuss family and fathering; (b) health and wellbeing; (c) mental health symptoms and conduct a risk assessment for suicidal ideation; (d) current supports and support needs; (e) provide referral options to telephone support services (PANDA; MensLine); and (f) encourage a general practitioner visit to discuss a mental health care plan.
15755554|NCT04813029|Procedure|Straight leg raise maneuver|With the patient in supine position, one leg is raised to form an angle of at least 45 degrees with the bed. The patient will be asked to keep that position for at least 5 seconds. The maneuver will be repeated after 20-30 seconds. The first adequate maneuver will be considered for the study. Intra-esophageal and intra-abdominal pressure will be analyzed both during baseline and SLR maneuver. Intra-esophageal pressure is measured as peak and mean over 5 seconds, 1 cm and 5 cm above the proximal margin of the LES. Intra-abdominal pressure will be measured as peak and mean over 5 seconds 1 cm below the distal margin of the diaphragm notch.
15755555|NCT04813016|Drug|Tramal 1|Early intraperitoneal injection of tramal and bupivacaine
15755556|NCT04813016|Drug|Tramal 2|Late intraperitoneal injection of tramal and bupivacaine
15755557|NCT04813016|Drug|Dexmedetomidine 1|Early intraperitoneal injection of dexmedetomidine and bupivacaine
15755558|NCT04813016|Drug|dexmedetomidine 2|Late intraperitoneal injection of dexmedetomedine and bupivacaine
15755559|NCT04813003|Other|Functional Brain Imaging and neurobehavioural tasks (Baseline)|"Combination of 3 neurobehavioural tasks:
~Task 1 consists in subjective value rating of 64 food items. Participants are asked to rate how much they would want to eat the presented food item while fMRI (functional magnetic resonance imaging ) scanning is performed.
~Task 2 consists in rating of subjective nutrient factor of the same 64 food items. Participants will answer the following four categorical questions in randomized order for each item: low or high in added sugar/protein/fat and healthy or unhealthy.
~Task 3 consists of a decision-making task. Participants will be presented with two food items (out of the 64 food items), and asked to choose which of the two items they prefer to consume at the end of the experiment."
15755560|NCT04813003|Other|Functional Brain Imaging and neurobehavioural tasks (Post-surgery)|"Combination of 3 neurobehavioural tasks:
~Task 1 consists in subjective value rating of 64 food items. Participants are asked to rate how much they would want to eat the presented food item while fMRI scanning is performed.
~Task 2 consists in rating of subjective nutrient factor of the same 64 food items. Participants will answer the following four categorical questions in randomized order for each item: low or high in added sugar/protein/fat and healthy or unhealthy.
~Task 3 consists of a decision-making task. Participants will be presented with two food items (out of the 64 food items), and asked to choose which of the two items they prefer to consume at the end of the experiment."
15755561|NCT04812977|Drug|Group A|Combination of intravitreal triamcinolone acetonide (Kenacort-AⓇ) (2mg/0.05ml) and intravitreal bevacizumab (Avastin®) (1.25mg/0.05ml)
15755593|NCT04812704|Dietary Supplement|Whey protein|Patient receive protein supplement in liquid form after each exercice session
15755704|NCT04811950|Device|Emerald|Complete blood countdevice
15755562|NCT04812964|Dietary Supplement|Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body mass|Standard protein diet as control, based on 0.5 gram protein per pound of lean body mass, isocaloric (same number of calories) and consisting of 15% protein and 55% carbohydrate.
15755563|NCT04812964|Dietary Supplement|Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrate|High level of protein diet, based on 1 gram of protein per pound of subject's lean body mass, isocaloric (same number of calories) and consisting of 30% protein and 40% carbohydrate.
15755564|NCT04812951|Drug|CycloSPORINE Ophthalmic 0.1% Ophthalmic Emulsion|one cyclosporine 0.1% eye drop twice a day for 30 preoperative days
15755565|NCT04812951|Device|cationorm eye drops|one cationorm eye drop twice a day for 30 preoperative days
15755566|NCT04812938|Diagnostic Test|Patients with Ovarian cancer and pap test available|Define the possibility to detect through the pap test the presence of ovarian cancer cells in vaginal smear in patients with no evidence of ginecological malignancies.
15755567|NCT04812925|Biological|efgartigimod PH20 SC|Subcutaneous injection with efgartigimod PH20 SC
15755568|NCT04812912|Diagnostic Test|Hormone biomarker analysis|For female patients, hormone biomarker analysis will be performed to measure: anti-Mullerian hormone (AMH), estradiol and FSH in the blood. In male patients, hormone biomarkers of testicular function and spermatogenesis will be monitored: testosterone, inhibin B, steroid hormone binding globulin (SHBG) and FSH. Sperm analysis will also be performed in male patients to monitor changes in sperm count.
15755569|NCT04812912|Behavioral|QoL Questionnaires|All participants will respond to protocol questionnaires, which will include both validated questionnaires as well as non-validated ones. This design will allow for basic demographic, psychosocial and sexual-health-related data to be obtained.
15755570|NCT04812899|Behavioral|Parental guided self-help version of FBT-pre-recorded videos and readings from the book|"Each participant will receive a series of pre-recorded videos of parental guided self help version FBT. There will be10 videos of about 10 minutes each. The videos will include content on empowering parents to renourish their child and interrupt binge/purge behaviors. Readings will be assigned to each participant from the book Help Your Teenager Beat and Eating Disorder. There will be psychoeducational content on the dangers and medical complications of eating disorders. The readings will also contain content on coping skills for young people including relaxation, mindfulness strategies, and distress tolerance skills."
15755571|NCT04812886|Other|Epidemiological study|Questionnaires (quality of life, gout, life habit, comorbidities) anthropometrics and health measures DNA analysis RNA analysis Metabolomic analysis
15755572|NCT04812860|Drug|HR18042|Tablet, Dosing frequency: once daily, Route of administration: oral
15755573|NCT04812860|Drug|HR18042|Tablet,Dosing frequency: once daily, Route of administration: oral
15755574|NCT04812860|Drug|HR18042|Tablet,Dosing frequency: once daily, Route of administration: oral
15755575|NCT04812860|Drug|Tramadol hydrochloride ER|Tablet,Dosing frequency: once daily, Route of administration: oral
15755576|NCT04812860|Drug|Placebo|Tablet,Dosing frequency: once daily, Route of administration: oral
15755577|NCT04812847|Diagnostic Test|Identification of MDR characteristics|Identification of MDR in culture media, followed by amplification of related genes from the bacterial isolates
15755578|NCT04812821|Other|questionnaire|questionnaire post delivery
15755580|NCT04812795|Other|Culturally tailored anti-smoking messages|Anti-smoking messages that are culturally tailored for sexual minority women.
15755581|NCT04812795|Other|Non-culturally tailored interventions|Anti-smoking messages that are not culturally tailored for sexual minority women.
15755582|NCT04812782|Dietary Supplement|EVOO supplementation|We will administer to both groups (healthy and T1D subjects) a high glycemic index meal enriched with EVOO
15755583|NCT04812782|Dietary Supplement|Butter supplementation|We will administer to both groups (healthy and T1D subjects) a high glycemic index meal enriched with butter
15755584|NCT04812769|Device|eCARE-ID|The intervention, eCARE-ID, consists of: 1) telehealth video clinical consultation services for nursing homes residents; 2) electronic consultation services for healthcare personnel; 3) telehealth video antibiotic stewardship services for healthcare personnel
15755585|NCT04812769|Other|Standard of Care|Standard of care will be delivered to the control home.
15755586|NCT04812756|Behavioral|Step-2-It - text messaging program|participants received a pedometer and text messages to motivate them to increase walking daily for a period of 12 weeks.
15755587|NCT04812743|Behavioral|Colorectal Health Research Champions|"20 Colorectal Health Research Champions will be recruited from Danville, Emporia, Lawrenceville, Richmond, and Petersburg.
~The Colorectal Health Research Champions will receive training in four specific areas during group educational sessions.
~Colorectal Health Research Champions will be asked to disseminate the four defined messages on at least two occasions to small groups in their social network in a venue of their choice (house chats, faith-based, social gatherings, family gatherings, etc.). We ask that each CHRC participant host 2 chats with 5-10 people in attendance at each chat. We expect that at least 200 participants will be invited to chats through 10 CHRCs."
15755588|NCT04812730|Other|2D versus 3D analysis of EOS stereo radiographic analysis|The use of EOS stereo radiographic analysis and health related quality of life scores to measure the distance of the center of acoustic meati in the transversal plane with respect to the gravity line
15755589|NCT04812730|Other|Static versus dynamic analysis|The use of clinical postural tests and instrumented movement analysis to evaluate the importance of muscle fatigue and compensation mechanisms
15755590|NCT04812730|Other|Pre- versus postoperative analysis|The use of EOS stereo radiographic imaging and motion analysis to understand the compensation mechanisms in trunk, pelvis and lower limbs and the correlation between primary and secondary mechanisms.
15755591|NCT04812730|Other|Reliability of the dynamic evaluation|Repeated measurements of the different aspects of the dynamic evaluation protocol (strenght measurements of trunk muscles, balance evaluation and movement analysis) will serve to evaluate the test-retest reliability and intra-rater reliability of the different protocols
15755592|NCT04812717|Device|CytoSorb device|The CytoSorb device will be placed in the CPB circuit in half of the study population during their cardiac operation.
15755594|NCT04812691|Biological|JWCAR029 (CD19-targeted Chimeric Antigen Receptor Cells)|Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JWCAR029. During JWCAR029 production, subjects will receive a conditioning chemotherapy regimen of cyclophosphamide and fludarabine for the purpose of lymphocytes depletion. After lymphodepletion, subjects will receive 1 x 10^8 CAR+T cells (JWCAR029) treatment by intravenous (IV) injection.
15755595|NCT04812678|Procedure|Fasciatherapy|Fasciatherapy, with manual therapy and/or gestual therapy.
15755596|NCT04812678|Procedure|Physiotherapy|Conventional physiotherapy with massage, exercises, electrotherapy, vertebral traction, heat, cold.
15755597|NCT04812665|Behavioral|mHealth solution based on emotional and behavioral change techniques|"Adhera supports the empowerment of patients with chronic conditions by supporting the acquisition of healthier lifestyles, improved mental wellbeing and grounded on the principles of behavioral change.
~The solution is based on incorporating the principles of personalized health education into a mobile platform which is achieved by applying the Integrated Model of Behavioral Change which is further adapted using recommender systems. Emotional and mental health elements, such as stress, resilience, are crucial part in the acquisition of self-management behaviors and will be the main focus of this intervention. Adhera adapts to provide tailored support to specific users' needs."
15755598|NCT04812652|Behavioral|Digitally distributed yoga|Yoga distributed through internet.
15755599|NCT04812639|Other|Buccal infiltration technique|a technique for injecting local anesthetic solution in the buccal mucobuccal fold between the roots of the targeted tooth
15755600|NCT04812639|Other|Inferior alveolar nerve block technique|a technique for injecting local anesthetic solution to anesthetize the inferior alveolar nerve
15755601|NCT04812626|Drug|5-Fluorouracil|Group A: 1ml of 40mg/ml triamcinolone acetonide will be mixed with 1ml of normal saline Group B:1 ml of 40 mg/ml triamcinolone acetonide will be mixed with 1ml of 50 mg/ml FU Five units (0.125ml) of the mixture TAC 40mg/ml and 5-FU 50mg/ml (1:1) i.e. 2.5mg TAC and 3.125mg of 5-FU or TAC 40mg/ml and 2%xylocaine (1:1) i.e. 2.5mg of TAC will be given intralesional with the help of 1ml insulin syringe of 40units, that covers an area of about 0.5X0.5 cm2 of scar, thus, a scar of 1 cm2 will require 4 injections to cover the whole lesion. Each extra area of 0.5x0.5cm2 will be given 5 units of injection of above mixture of drugs. For the larger lesions, dose can be increased but no more than 2ml in each group. Injection will be given at 2 weeks interval for total of 6 sessions (at 0,2, 4, 6,8,10 weeks) Post treatment follow up: at 12 weeks.
15755602|NCT04812613|Other|Phase 2 Intervention|An appropriately designed intervention will be created based off the qualitative data obtained from the participants and key-informants in phase 1 of the study. The intervention will first involve acquiring consent for participation and a baseline questionnaire, including: 1) demographic information, detailed poly-substance use history, and a social network questionnaire 2) EQ-5D-3L test to measure quality of life; 3) Patient Health Questionnaire to establish depressive disorder anxiety disorder. These same questions and tests will be also be administered at the end of the 6-month study to assess change substance use behavior, mental health and quality of life. For the next six months monthly follow-ups will occur, including iPad-based follow-up surveys (focusing on current substance use status) and weekly peer-led life skills workshops. A licensed addiction nurse will be available to youth throughout the study to discuss an individualized treatment plan.
15755603|NCT04812587|Behavioral|exercise intervention program|The experimental group will receive a 12-week combined exercise intervention program with extra emphasis on balance, muscle strength, and walking ability which involved two 2-hour sessions once per week.
15755604|NCT04812574|Procedure|Periurethral injection|Patients were in the lithotomy position for the procedure. After preparation, topical Lidocaine gel was instilled around the meatus and a 16 F probe was attached. The catheter balloon was inflated to localize the bladder neck and to ensure that injections were performed in the correct anatomical plane. Hypertonic saline (10% NaCl) was injected to the alignment of the urethral meatus in the order of 3-6-9-12 hours of the clock (5 cc to each site, totaling 20 cc). Syringes with 27 Gauge (0.40 mm) outer diameter were used to ensure controlled injection. Since the female urethra is about 4 cm in length, the needle was advanced about 3 cm. Due to the possibility of significant pain with hypertonic saline, 2 cc of Lidocaine hydrochloride was added into the solution.
15755605|NCT04812574|Drug|Hypertonic (10%) saline|Periurethral hypertonic saline (10%)
15755606|NCT04812561|Dietary Supplement|Bronch™|2 times a day, 1 pill for 1 time, after breakfast/dinner meal, for 12 week
15755607|NCT04812561|Dietary Supplement|placebo|2 times a day, 1 pill for 1 time, after breakfast/dinner meal, for 12 week
15755608|NCT04812548|Drug|sabatolimab|Sabatolimab will be administered at a low dose (Safety run-in (Part 1) cohort 1) or a high dose (Safety run-in (Part 1) cohort 2 and Expansion (Part 2)) via i.v. infusion over 30 minutes on Day 8 of every treatment cycle.
15755609|NCT04812548|Drug|azacitidine|A standard dose of azacitidine will be given subcutaneously or intravenously every day for seven consecutive days on days 1-7 of a confirmed treatment cycle. In keeping with standard clinical practice, the alternative schedules for five consecutive days on days 1-5, followed by a two day break, then two consecutive days on days 8-9 will be permitted (alternative schedule).
15755610|NCT04812548|Drug|venetoclax|Venetoclax film-coated tablets will be administered at a dose of 400 mg orally or corresponding reduced dose for concomitant use with P-gp inhibitors or moderate or strong CYP3A4 inhibitors, once a day, from C1D1 to C1D14 during the treatment cycle. No ramp-up for venetoclax is necessary.
15755611|NCT04812535|Drug|IFX-1|IFX-1 Monotherapy
15755612|NCT04812535|Drug|IFX-1 + pembrolizumab combination therapy|IFX-1 + pembrolizumab combination therapy
15755613|NCT04812522|Behavioral|Clean Cut program|Clean Cut, is an adaptive, multimodal surgical infection prevention program that integrates perioperative process improvement and patient outcomes measurement using process mapping, training and improved management practices, and compliance with critical standards of surgical antisepsis
15755614|NCT04812509|Drug|MW032|The active ingredient of MW032 is a recombinant human anti-RANKL monoclonal antibody ,subcutaneous injection of 120 mg (1.7ml)every 4 weeks for a maximum of 13 consecutive doses throughout the trial.
15755615|NCT04812509|Drug|Xgeva|The active ingredient of Xgeva® is denosumab,subcutaneous injection of 120 mg (1.7ml)every 4 weeks for a maximum of 13 consecutive doses throughout the trial.
15755657|NCT04812197|Procedure|Biospecimen Collection(Punch Biopsy)|Punch Biopsy of Skin
15755658|NCT04812184|Device|Tape Face Mask|Adding tape to face mask
15755810|NCT04811079|Other|373 nm Spectacle Filter|CONTROL
15755618|NCT04812470|Drug|Autologous Tumor Infiltrating Lymphocytes|Administered via hepatic arterial infusion
15755619|NCT04812470|Drug|Melphalan|Melphalan will be administered once as an intravenous infusion.
15755620|NCT04812470|Drug|Interleukin-2|After TIL infusion, Interleukin-2 will be administered subcutaneously once daily for up to 14 days.
15755621|NCT04812457|Drug|Hialucic|A professional not present at the intervention (researcher 2) will proceed to carry out the postoperative cures 48 hours after the intervention. The bandage will be removed, the area will be washed with physiological saline and the drug will be applied according to the group to which it belongs. In the intervention group, an ointment with hyaluronic acid (hyalucic ®) will be used together with a non-stick dressing and a semi-compression bandage to prevent bleeding.
15755622|NCT04812457|Drug|Betadine gel|A professional not present at the intervention (researcher 2) will proceed to carry out the postoperative cures 48 hours after the intervention. The bandage will be removed, the area will be washed with physiological saline and the drug will be applied according to the group to which it belongs. In the control group, Betadine Gel will be used together with a non-stick dressing and a semi-compression bandage to prevent bleeding.
15755623|NCT04812444|Device|Zylox Peripheral Venous Stent|Self-expanding stent implantation during the index procedure.
15755624|NCT04812444|Device|Zilver Vena Venous Stent|Self-expanding stent implantation during the index procedure.
15755625|NCT04812431|Biological|Neural precursor cells derived from human embryonic stem cell line|When the Dose Limiting Toxicity (DLT) is not presented in the first three subjects administered with PSA-NCAM(+) NPC, two additional patients are added to the clinical study.
15755626|NCT04812418|Dietary Supplement|Noctesia|3 tablets every day at bedtime with a large glass of water
15755627|NCT04812418|Dietary Supplement|Placebo|3 tablets every day at bedtime with a large glass of water
15755628|NCT04812405|Diagnostic Test|Trios4|Examination of occlusal surfaces with 3D scanner and optical criteria
15755629|NCT04812392|Device|Continuous Glucose Monitoring System|Subjects will wear a continuous glucose monitoring system for 5 days during the 5 day reduced physical activity phase.
15755630|NCT04812379|Drug|Abilify prolonged release aqueous suspension for IM injection (Aripiprazole)|The usual dose in adults is 400 mg of aripiprazole administered intramuscularly in the gluteal or deltoid muscle as a single dose once every 4 weeks. The dose may be decreased to 300 mg based on the patient's symptoms and tolerability.
15755631|NCT04812366|Drug|Apalutamide 60mg Tab|4 tablets by mouth once a day for 24 weeks
15755632|NCT04812366|Drug|Abiraterone Acetate 250mg|4 tablets by mouth on an empty stomach once a day for 16 weeks
15755633|NCT04812366|Drug|Prednisone 5mg Tab|1 tablet by mouth once daily while taking abiraterone acetate
15755634|NCT04812366|Drug|Docetaxel|Infusion every 3 weeks for 6 cycles (each cycle has 3 weeks)
15755635|NCT04812366|Drug|Niraparib 100mg Oral Capsule|3 capsules by mouth once daily for 16 weeks
15755636|NCT04812353|Other|Follow-up of Io-Fix type fixation|Follow-up of patients who underwent a foot- or ankle reconstruction surgery using the Io-Fix system
15755637|NCT04812340|Other|High intensity circuit training|6 series with 3 minutes rest between the series. each series will consist of 30 seconds each of burpees, skipping, lunges, 1- legged squat, leg levers, and push-ups with 30 seconds rest in between. the volume of exercise will be increased progressively over a period of 8 weeks.
15755638|NCT04812340|Other|Low intensity interval training|4 series with 3 minutes rest in between. each series will consist of 10 minutes of jogging and 5 minutes walking with 30 seconds recovery in between. the volume of exercise will be increased progressively over a period of 8 weeks.
15755639|NCT04812327|Diagnostic Test|BD Veritor Plus System for Rapid Detection of SARS CoV-2|Nasal Sawb for the conduct of the Veritor Antigen Test
15755640|NCT04812327|Diagnostic Test|rt-PCR|Nasopharyngeal Swab for the conduct of a rt-PCR
15755641|NCT04812327|Diagnostic Test|viral culture|Nasopharyngeal Swab for the conduct of viral culture
15755642|NCT04812314|Behavioral|Exercise|Participants will complete a moderate intensity continuous exercise 4 days/week.
15755643|NCT04812314|Behavioral|No exercise|Participants will remain sedentary throughout the duration of the study.
15755644|NCT04812301|Radiation|Egg-white sandwich|1 mCi of Tc-99m sodium phytate is added into the egg-white sandwich
15755645|NCT04812301|Radiation|Abbott Vital®|1 mCi of Tc-99m sodium phytate is added into the Abbott Vital®
15755646|NCT04812275|Procedure|Skin closure|Skin closure
15755647|NCT04812262|Drug|DD01|The active of DD01 is a synthetic peptide, administered in a 1mL volume for injection.
15755648|NCT04812262|Drug|Placebo|Placebo drug of DD01, administered in a 1mL volume for injection
15755649|NCT04812249|Other|Clinical assessment|Clinical assessment and follow up of oral feeding ability
15755650|NCT04812236|Drug|Wulingsan single decoction granules|Wulingsan single decoction granules, the prescription is Alisma, Polyporus, Atractylodes, Poria, Guizhi. Oral, 2 times a day, 2 sachets each time, rinsed with warm water
15755651|NCT04812236|Drug|Wulingsan co-decoction granules|Wulingsan co-decoction granules, the prescription is Alisma, Polyporus, Atractylodes, Poria, Guizhi. Oral, 2 times a day, 2 sachets each time, rinsed with warm water
15755652|NCT04812236|Drug|Wuling Powder|Wuling powder is composed of Alisma, Polyporus, Atractylodes, Poria, Guizhi. 2 times a day, 5g each time, take it with warm water
15755653|NCT04812236|Drug|Wulingsan granule simulant|Wulingsan granule simulant, the prescription is Alisma, Polyporus, Atractylodes, Poria, Guizhi. Oral, 2 times a day, 2 sachets each time, rinsed with warm water
15755654|NCT04812223|Procedure|Delayed umbilical cord clamping|The umbilical cord will be clamped 60 seconds after the baby is born.
15755655|NCT04812223|Procedure|Early umbilical cord clamping|The umbilical cord will be clamped 15 seconds after the baby is born.
15755656|NCT04812223|Procedure|Milking of the umbilical cord|The cord will be milked 5 times with 2 seconds milking, then letting 2 seconds for spontaneous blood flow.
15755660|NCT04812158|Other|standard ankle physiotherapy or rehabilitation for chronic ankle instability|6 weeks of combined interventions of video aided mindful deep breathing and standard ankle physiotherapy in rehabilitating the chronic ankle instability for participants with chronic ankle instability
15755661|NCT04812145|Radiation|Chemoradiation|Hypofractionated radiotherapy with concurrent Gemcitabine
15755662|NCT04812132|Procedure|One-anastomosis gastric bypass|One group is planned to have one-anastomosis gastric bypass (also known as mini-bypass)
15755663|NCT04812132|Procedure|Long biliary limb Roux gastric bypass|Other group is planned to receive a long biliary limb Roux gastric bypass
15755664|NCT04812119|Diagnostic Test|The Modified Checklist for Autism in Toddlers, Revised with Follow-Up (M-CHAT-R/F)|The Modified Checklist for Autism in Toddlers, Revised with Follow-Up (M-CHAT-R/F; Robins, Fein, & Barton, 2009) is a 2-stage parent-report screening tool to assess risk for Autism Spectrum Disorder (ASD). It is valid for children 16-30 months old.
15755665|NCT04812119|Diagnostic Test|The Autism Spectrum Quotient-Children's Version (AQ-Child)|"The Autism Spectrum Quotient-Children's Version (AQ-Child; Auyeung, Baron-Cohen, Wheelwright & Allison, 2008) is a parent-report questionnaire that aims to quantify autistic traits in children 4-11 years old. It contains 50 likert-type items with responses ranging from definitely agree to definitely disagree."
15755666|NCT04812119|Diagnostic Test|The Autism-Spectrum Quotient (AQ)-Adolescent Version (AQ-Adolescent)|"The Autism Spectrum Quotient-Children's Version (AQ-Child; Auyeung, Baron-Cohen, Wheelwright & Allison, 2008) is a parent-report questionnaire that aims to quantify autistic traits in children 12-15 years old. It contains 50 likert-type items with responses ranging from definitely agree to definitely disagree."
15755667|NCT04812119|Diagnostic Test|The Viking's Speech Scale|The Viking Speech Scale (Pennington, Virella, Mjøen, da Graça Andrada, Murray, Colver, … & Andersen, 2013) is used to classify children's speech production, specifically the ease at which children can make themselves understood using different methods of communication. The scale has four levels and is ordinal. The four levels include: (1) speech is not affected by motor disorder (2) speech is imprecise but usually understandable to unfamiliar listeners (3) speech is unclear and not usually understandable to unfamiliar listeners out of context (3) no understandable speech. It is intended for children above the age of 4 years.
15755668|NCT04812119|Diagnostic Test|The Functional Communication Classification System (FCCS)|The Functional Communication Classification System (Barty, Caynes & Johnston, 2016) was designed to classify how children with cerebral palsy communicate on a daily basis. The tool focuses on how children typically communicate with familiar and unfamiliar communication partners. There are five classifications a child can be categorized in: (1) effective communicator in most situations (2) effective communicator in most situations, but does need some help (3) an effective communicator in most situations and can communicate small ranges of messages and topics to most familiar people (4) assistance is required in most situations, especially with unfamiliar people and environments. Communicates daily needs and wants to familiar people (5) communicates using undirected movement, vocalisation and/or behaviour, for interpretation by familiar people. The FCCS is valid for use in children up to 13 years.
15755669|NCT04812119|Diagnostic Test|Brief Infant Sleeping Questionnaire (BISQ)|The Brief Infant Sleep Questionnaire (BISQ; Sadeh, 2004) is used to assess sleep patterns, parent perception, and sleep-related behaviors in young children (0-36 months). The BISQ has been validated against actigraphy, daily logs, and has high sensitivity in documenting expected developmental trends in sleep.
15755670|NCT04812119|Diagnostic Test|Pediatric Sleep Questionnaire (PSQ)|Pediatric Sleep Questionnaire (PSQ; Chervin, Hedger, Dillon, Pituch, 2000) has been designed to screen for sleep problems in children. The scale consists of 22 parent-reported items examining snoring and breathing problems, daytime sleepiness, inattention, hyperactivity, and other signs and symptoms of apnea including obesity and nocturnal enuresis. Those questions specifically relate to sleep-disordered breathing (SDB) in children. PSQ has been validated for children 2-18 years old.
15755671|NCT04812119|Diagnostic Test|The Eating and Drinking Ability Classification System (EDACS)|The Eating and Drinking Ability Classification System (EDACS; Sellers, Mandy, Pennington, Hankins, Morris, 2013) has been developed for people with cerebral palsy to describe five distinct levels of ability using the key features of safety and efficiency. The patient can be categorized in: (1) eats and drinks safely and efficiently, (2) eats and drinks safely but with some limitations to efficiency, (3) eats and drinks with some limitations to safety; maybe limitations to efficiency, (4) eats and drinks with significant limitations to safety or (5) unable to eat or drink safely - tube feeding may be considered to provide nutrition. The EDACS is valid for use in children above the age of 36 months.
15755672|NCT04812119|Diagnostic Test|Mini Manual Ability Classification System (Mini-MACS)|The Mini Manual Ability Classification System (Mini-MACS; Eliasson, Krumlinde-Sundholm, 2013) describes how children with cerebral palsy use their hands to handle objects in daily activities. MACS describes five levels. The levels are based on the children's self-initiated ability to handle objects and their need for assistance or adaptation to perform manual activities in everyday life. It has been validated for children 1-4 years of age.
15755673|NCT04812119|Diagnostic Test|Manual Ability Classification System (MACS)|The Manual Ability Classification System (MACS; Eliasson, Krumlinde Sundholm, Rösblad, Beckung, Arner, Öhrvall, Rosenbaum, 2006) describes how children with cerebral palsy use their hands to handle objects in daily activities. MACS describes five levels. The levels are based on the children's self-initiated ability to handle objects and their need for assistance or adaptation to perform manual activities in everyday life. It has been validated for children 4-18 years.
15755674|NCT04812119|Diagnostic Test|The Gross Motor Function Classification System - Expanded and Revised (GMFCS - E&R)|The Gross Motor Function Classification System - Expanded & Revised (GMFCS - E&R; Palisano, Rosenbaum, Bartlett, Livingston, 2007) is a 5-level classification system that describes the gross motor function of children and youth with cerebral palsy on the basis of their self-initiated movement with particular emphasis on sitting, walking, and wheeled mobility. Distinctions between levels are based on functional abilities, the need for assistive technology, including hand-held mobility devices (walkers, crutches, or canes) or wheeled mobility, and to a much lesser extent, quality of movement. The questionnaire is available for four age groups of children and youth: 2 to < 4 years, 4 to < 6 years, 6 to < 12 years, and 12 to 18 years.
15755675|NCT04812119|Diagnostic Test|The Visual Function Classification System (VFCS)|The Visual Function Classification System (Baranello et al, 2019) is a valid and reliable 5-level classification system of visual functioning for children with Cerebral Palsy. It describes the use of visual abilities in daily life, focusing on activity and participation.
15755676|NCT04812119|Diagnostic Test|The Early Childhood Oral Health Impact Scale (ECOHIS)|The ECOHIS measures the impact of oral problems and/or experience of dental treatment on the quality of life in children under 5 years old and their parents or other family members. It has 13 questions divided into two domains: one related to impact on the child (9 questions), and another to impact on the family (4 questions), measured using the Likert scale. In children with cerebral palsy and/or the ECOHIS has been validated for ages up to 6,5 years, in children with intellectual disability for ages up to 5 years and in children with special need for ages up to 9 years.
15755677|NCT04812119|Diagnostic Test|The Family Impact Scale (FIS)|The FIS evaluates the impact of a child's oral condition on family life. It consists of 14 items divided into three subscales: parental/family activity (PA), parental emotions (PE), and family conflict (FC). The financial burden subscale (FB) is the only one that is evaluated separately, since it comprises a single item and addresses economic rather than psychosocial or behavioural impact. It has been validated for children above the age of 12 years.
15755678|NCT04812119|Diagnostic Test|The Achenbach System of Empirically Based Assessment (ASEBA)|The Achenbach System of Empirically Based Assessment (ASEBA; Achenbach) is a collection of questionnaires used to assess adaptive and maladaptive behavior and overall functioning in individuals. The system includes report forms for multiple informants - the Child Behavior Checklist (CBCL) is used for caregivers to fill out ratings of their child's behavior, the Youth Self Report Form (YSR) is used for children to rate their own behavior, and the Teacher Report Form (TRF) is used for teachers to rate their pupil's behavior. The ASEBA seeks to capture consistencies or variations in behavior across different situations and with different interaction partners. The ASEBA exists for multiple age groups, including preschool-aged children, school-aged children, adults, and older adults. Scores for individuals in each age group are norm-referenced.
15755679|NCT04812119|Diagnostic Test|Adaptive Behavior Assessment System Third Edition (ABAS-3)|The ABAS-3 (Harrison, Oakland, 2015) is a rating scale useful for assessing skills of daily living in individuals with developmental delays, autism spectrum disorder, intellectual disability, learning disabilities, neuropsychological disorders, and sensory or physical impairments. Rating forms are filled out by the parent and a teacher. The ABAS-3 covers three broad domains: conceptual, social, and practical, using 11 skill areas within these domains. Tasks focus on everyday activities required to function, meet environmental demands, care for oneself, and interact with others effectively and independently. On a 4-point response scale, raters indicate whether, and how frequently, the individual performs each activity.
15755680|NCT04812106|Other|No Intervention|No Intervention
15755681|NCT04812093|Device|Spectroscopic otoscope measurements|Spectroscopic otoscope measurements are taken with the investigational device. Each measurement consists of placing the device in the ear canal and illuminating the ear with multiple light sources in a short period of time. If wax is present in the ear canal, it is removed by the study physician and another measurement is taken.
15755682|NCT04812080|Device|EXPLORER PET/CT|FDG PET Scans on the total body EXPLORER PET/CT scanner
15755683|NCT04812067|Drug|TTHX1114|engineered FGF-1
15755684|NCT04812054|Procedure|Hypothermic oxygenated machine perfusion|Hypothermic oxygenated perfusion using a Liver Assist device (Organ Assist, Groningen, the Netherlands). Temperature of the perfusate will be set to 12 degrees Celsius. Dedicated cannulas will be placed in the aorta for arterial perfusion and in the portal vein for portal perfusion. Pressure will be set at 25 mmHg for arterial line (pulsatile flow, 30 mmHg systolic pressure and 20 mmHg diastolic pressure, 60 beats per minute) and 3 mmHg for portal line (continuous flow). 100% oxygen will be supplied to the oxygenators with a flow of 500 ml / min or higher, in order to achieve pO2 of at least 450 mmHg.
15755685|NCT04812054|Procedure|Simple cold storage|Following back-table preparation, the allograft will either be transferred to the operating room for implantation or stored in preservation solution at 4 degrees Celsius in a refrigerator
15755686|NCT04812041|Other|CAM-ICU 7 score|A 7-point rating scale (0-7) was derived from the CAM-ICU and RASS assessments 0-2: no delirium, 3-5: mild to moderate delirium, and 6-7: severe delirium.
15755687|NCT04812041|Other|4C Mortality Score|4C Mortality Scores of the patients will be calculated, according to age, gender, number of comorbidities, respiratory rate, SpO2, GCS, urea, and CRP parameters
15755688|NCT04812028|Drug|Magnesium sulfate|Magnesium sulfate (MgSO4) will be administered intravenously at induction of anesthesia as a 30-minute bolus dose of 50 mg/kg (maximum 2 grams) in the OR, followed by a 15 mg/kg/hr IV infusion for 48 hours or once the patient has transferred out of the PICU, whichever comes first.
15755689|NCT04812015|Device|transcutaneous auricular vagus nerve stimulation (taVNS) 10 minutes|Sham 80 minutes and taVNS active stimulation for 10 minutes
15755690|NCT04812015|Device|taVNS 20 minutes|Sham 70 minutes and taVNS active stimulation for 20 minutes
15755691|NCT04812015|Device|taVNS 30 minutes|Sham 60 minutes and taVNS active stimulation for 30 minutes
15755692|NCT04812015|Device|taVNS 40 minutes|Sham 50 minutes and taVNS active stimulation for 40 minutes
15755693|NCT04812015|Device|taVNS 50 minutes|Sham 40 minutes and taVNS active stimulation for 50 minutes
15755694|NCT04812015|Device|taVNS 60 minutes|Sham 30 minutes and taVNS active stimulation for 60 minutes
15755695|NCT04812015|Device|taVNS 70 minutes|Sham 20 minutes and taVNS active stimulation for 70 minutes
15755696|NCT04812015|Device|taVNS 80 minutes|Sham 10 minutes and taVNS active stimulation for 80 minutes
15755697|NCT04812015|Device|taVNS 90 minutes|Sham 0 minutes and taVNS active stimulation for 90 minutes
15755698|NCT04812002|Drug|PD-1 inhibitor， bevacizumab|Both drugs are given intravenously
15755699|NCT04811989|Behavioral|Instructive video on diabetic foot care|In the video, the diabetic foot care is presented verbally and appropriately captioned, as well as exemplified by real patients and health professionals from the hospital
15755700|NCT04811989|Behavioral|Informative leaflet with real-time guided reading|The leaflet has information about diabetic foot care. Researcher will guide its reading with patients.
15755701|NCT04811989|Behavioral|Informative leaflet to read at home|Patients receive a leaflet about diabetic foot care to read at home.
15755702|NCT04811989|Behavioral|Face-to-face teaching|Face-to-face teaching includes the teaching about diabetic foot care during the consultation by health professionals.
15755703|NCT04811963|Device|Non-Invasive Controlled Hypoxia|Following arterial cannulation, hypoxia is induced by reducing the percent of inspired oxygen the subject breathes while simultaneous measurements are recorded from the test pulse oximeters and arterial blood samples are collected at targeted levels of saturation.
15755705|NCT04811937|Diagnostic Test|Computer-aided polypectomy decision support by Artificial Intelligence|The AI system will capture the live video of the procedure and the AI feedbackwill be shown on a second screen installed next to the regular endoscopy screen. Screen A will show the regular endoscopy image and screen B will show the regular endoscopy image together with the areas that might harbor a polyp and the information to help the polypectomy.
15755706|NCT04811924|Drug|Application of 0.02% MMC over 60 seconds post corneal crosslinking.|Topical application of 0.02% MMC on the surface of the cornea post CXL. The surface of the eye is washed thoroughly with Balanced Salt Solution (BSS) over 1 minute after MMC application.
15755707|NCT04811924|Drug|Corneal crosslinking without the application of 0.02% MMC|Topical application of placebo on the surface of the cornea post CXL. The surface of the eye is washed thoroughly with Balanced Salt Solution (BSS) over 1 minute after placebo application.
15755708|NCT04811911|Radiation|Narrowband ultraviolet B|Patients will receive 8 sessions of NB-UVB per month for 3 successive months
15755709|NCT04811911|Drug|Methotrexate|Patients will receive 25 mg/1ml of methotrexate vial per week for 3 successive months
15755710|NCT04811898|Biological|LNA-i-miR-221|LNA-i-miR-221, IV daily infusion on days 1-4 followed by 24 days washout (1 cycle lasting 28 days)
15755711|NCT04811885|Other|The Effects of Covid 19 Pandemic on the Cardiovascular Heath of Children With Autism Spectrum Disorder|The Effects of Covid 19 Pandemic on the Cardiovascular Heath of Children With Autism Spectrum Disorder
15755712|NCT04811872|Biological|Intact umbilical cord milking (I-UCM)|Umblical cord milking will be performed by holding the newborn at or ∼20 cm below the level of the placenta. The cord will be pinched between 2 fingers as close to the placenta as possible and milked toward the infant over a 2-second duration. The cord will then be released and allowed to refill with blood for a brief 1- to 2-second pause between each milking motion. This will be repeated for 2-4 times. After completion, the cord will be clamped, and the neonate will be handed to the resuscitation team.
15755713|NCT04811872|Biological|Cut-umbilical cord milking(C-UCM)|This technique involves clamping and cutting a long segment of the umbilical cord immediately at birth and passing the baby and the long cord to the pediatric provider, called C-UCM untwists the cord and milks the entire contents into the baby. Milking the cord 2-3 times before clamping may produce a similar placental transfusion as C-UCM.
15755714|NCT04811872|Biological|Delayed Cord Clamping (DCC)|Infants placed on the maternal abdomen or at the introitus below the level of placenta and waiting at least 30- to 60 seconds before clamping the cord.
15755715|NCT04811859|Other|Inspiratory Muscle Training|Inspiratory Muscle Training is a form of resistance (weight) training which strengthens the muscles that you use to breathe. When these muscles are strengthened regularly for a period of a few weeks they adapt, becoming stronger and being able to work for longer.
15755716|NCT04811846|Device|Bipolar transurethral resection of bladder tumor (TURBT)|Standard resection in piecemeal technique with standard bipolar cutting loop. (Storz medical, 27040 GP1)
15755717|NCT04811846|Device|Bipolar transurethral plasma kinetic vaporization of bladder tumor (PKVBT)|Vaporization of bladder tumor with standard bipolar vaporization electrode. (Storz medical, 27040 NB)
15755718|NCT04811807|Device|Subthalamic Nucleaus Deep brain stimulation|In deep brain stimulation (DBS) therapy, a specific anatomical target in the brain is stimulated via surgically fixed electrodes. These electrodes release electrical currents of a specific voltage, wavelength, and frequency. They are connected via subcutaneous wires to a device called an implantable pulse generator (IPG) which is surgically fixed on chest wall, beneath the clavicle. After electrodes and IPG are successfully installed, a clinician will be able to adjust and modulate the stimulation via a remote device connected to the IPG to obtain a maximum potential benefit. Deep brain stimulation has been used in clinics to treat various neurologic diseases including neurodegenerative disorders, mainly movement disorders.
15755719|NCT04811794|Other|Physical examination, diagnostic tests, laboratory tests|Physical examination, diagnostic tests (e.g. lung function test, echocardiography, audiometry), and laboratory tests (e.g. kidney parameter, hormonal levels) depend on examined organ system.
15755720|NCT04811794|Other|Personal history|Personal history on diagnosis, treatment, and socioeconomic factors
15755721|NCT04811768|Procedure|Maxillary sinus augmentation|The surgery was performed under local anaesthesia in both groups, lateral window preparation and window coverage was carried out based on randomization.
15755722|NCT04811755|Behavioral|Surgical timing from ED admission to surgery|the impact of delay of time between patient admission to ED and surgery for source control on 90-d mortality and postoperative outcomes in patients with gastrointestinal perforation with or without septic shock
15755723|NCT04811742|Other|bathing|immerson bathing and showering
15755724|NCT04811729|Behavioral|Motivational interview|The participants will apply an approach based on the Motivational Interview (Rollnick, 2008) in patients with excessive alcohol consumption, previously receiving a training program
15755725|NCT04811729|Behavioral|Medical advice|Usual care
15755726|NCT04811716|Drug|Pozelimab|Administered Sub-cutaneous (SC) per protocol
15755727|NCT04811716|Drug|Cemdisiran|Administered SC per protocol
15755728|NCT04811703|Drug|Combined PIPAC / IV chemotherapy treatment|Addition of cisplatin-doxorubicin PIPAC sessions to carboplatin-paclitaxel systemic Chemotherapy
15755729|NCT04811690|Behavioral|front-of-package modification|testing front-of-package changes to claims, imagery, disclosures, and added sugar warning labels on fruit-flavored drinks
15755730|NCT04811677|Other|radiology|image analysis
15755731|NCT04811664|Biological|Moderna COVID-19 Vaccine|A lipid nanoparticle (LNP) dispersion of a messenger ribonucleic acid (mRNA) encoding the prefusion stabilized S protein of SARS-CoV-2 formulated in LNPs composed of 4 lipids (1 proprietary and 3 commercially available). It is a suspension for intramuscular injection administered as a series of two doses (0.5 mL each) 1 month apart.
15755732|NCT04811651|Biological|Umbilical Cord-derived Mesenchymal Stem Cells|umbilical cord derived mesenchymal stem cells were intravenously injected in a single dose of one hundred million.
15755733|NCT04811651|Drug|Placebo|intravenous placebo solution with the same appearance as the treatment group.
15755734|NCT04811638|Other|Validation of the Chelsea Critical Care Physical Assesment Tools|The validation of the CPAX tools will focus on the validity of constructs, internal consistency reliability and test-retest reliability. PFIT used for criterion validity.
15755735|NCT04811625|Drug|PL-ASA|Pharmacologic profile of different aspirin formulations
15755736|NCT04811612|Diagnostic Test|Warmed heel stick|One heel will be warmed before sampling with the other heel will not be warmed
15755737|NCT04811586|Procedure|coronary revascularization|to improve the blood supply for coronary arteries by using either percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG)
15755738|NCT04811573|Drug|EU-sourced Otezla® (T)|Test Treatment (T)
15755739|NCT04811573|Drug|US-sourced Otezla® (R1)|Reference Treatment (R1)
15755740|NCT04811573|Drug|Japan-sourced Otezla® (R2)|Reference Treatment (R2)
15755741|NCT04811560|Drug|JNJ-75276617|JNJ-75276617 is administered orally.
15755742|NCT04811534|Behavioral|Interview|Mixed exploratory study, mixing a mainly qualitative study (semi-directed interviews) with a descriptive observational study (short self-questionnaire of the interviewees).
15755743|NCT04811521|Behavioral|Primary care follow-up|Those randomized to primary care and enhanced primary care coordination will receive the minimal intensity treatment that includes: (1) assistance in identifying a primary care provider for participants who do not have one, (2) sharing results of diagnostic testing (including anxiety screening) with the primary care provider (results sent via EMR note, mailed letter, or delivered by participant at appointment); and (3) an educational brochure on anxiety and treatment.
15755744|NCT04811521|Behavioral|Online Self-Administered Anxiety Management Program plus Peer Support Guidance|Individuals randomized to the online Cognitive Behavioral Therapy (CBT) + peer support guidance arm will receive access to six online, evidence-based CBT modules in the This Way Up Generalized Anxiety Course to be completed weekly or bi-monthly. Individuals who screen positive on the PHQ panic measure will complete 2 additional panic-specific homework assignments applying exposure therapy to panic (in addition to Generalized Anxiety Disorder) experiences aligned with content from the This Way Up Panic Course.
15755745|NCT04811521|Behavioral|Therapist-Administered Cognitive Behavioral Therapy|Individuals randomized to therapist-led CBT via telehealth will receive 8 one-hour sessions over the course of 8 to 10 weeks via telehealth (HIPAA compliant software such as Zoom Health or AmWell) or telephone. Therapists will be master's-degreed or eligible clinicians trained in CBT by our study psychologist. Therapists will follow a manualized protocol for delivering CBT for anxiety, specifically, with a primary focus on anxiety and worry management. Individuals who screen positive on the PHQ panic measure will have training in exposure therapy added to CBT. Although many CBT trials have a standard length of 12 sessions, brief CBT lasting 4-8 sessions is equally efficacious.
15755746|NCT04811495|Other|Physiotherapy treatment|A treatment plan is carried out which aims to improve pain, muscle balance and range of motion of the temporomandibular joint.
15755747|NCT04811482|Behavioral|TCIT-CALM (Teacher-Child Interaction Training-CALM)|This intervention is designed to treat early childhood anxiety. It is an adaptation of parent-child interaction therapy (PCIT), in which teachers rather than parents are targeted as the therapeutic agent of change. The intervention follows the procedures of the CALM protocol, in which caregivers are taught play therapy skills to support and address anxious behaviors and avoidance.
15755748|NCT04811469|Drug|CBP-174 Dosage 1|Dosage 1, oral solution, given once
15755749|NCT04811469|Drug|Placebo to match CBP-174 Dosage 1|placebo to match CBP-174 Dosage 1, given once
15755750|NCT04811469|Drug|CBP-174 Dosage 2|Dosage 2, oral solution, given once
15755751|NCT04811469|Drug|Placebo to match CBP-174 Dosage 2|placebo to match CBP-174 Dosage 2, given once
15755752|NCT04811469|Drug|CBP-174 Dosage 3|Dosage 3, oral solution, given once
15755753|NCT04811469|Drug|Placebo to match CBP-174 Dosage 3|placebo to match CBP-174 Dosage 3, given once
15755754|NCT04811469|Drug|CBP-174 Dosage 4|Dosage 4, oral solution, given once
15755755|NCT04811469|Drug|Placebo to match CBP-174 Dosage 4|placebo to match CBP-174 Dosage 4, given once
15755756|NCT04811469|Drug|CBP-174 Dosage 5|Dosage 5, oral solution, given once
15755757|NCT04811469|Drug|Placebo to match CBP-174 Dosage 5|placebo to match CBP-174 Dosage 5, given once
15755758|NCT04811469|Drug|CBP-174 Dosage 6|Dosage 6, oral solution, given once
15755759|NCT04811469|Drug|Placebo to match CBP-174 Dosage 6|placebo to match CBP-174 Dosage 6, given once
15755760|NCT04811456|Other|multisystem inflammatory syndrome in children (MIS-C)|as in group description
15755761|NCT04811443|Drug|Empegfilgrastim|Extimia®
15755762|NCT04811430|Device|Randomized Traditional|Traditional ultrasound guidance was utilized to insert Midlines on simulated veins blocks not live patients
15755763|NCT04811430|Device|Cue(TM) Needle Tracking Technology|Cue(TM) Needle Tracking Technology with real time needle tip tracking is used to assist ultrasound guided midline insertions on simulated veins blocks not live patients
15755764|NCT04811404|Drug|Ethyl Eicosapentaenoic Acid|Treatment will be for six weeks
15755765|NCT04811391|Biological|COVID-19 vaccine|Observation of individuals who receive the COVID-19 vaccine (2 doses of PfizerBioNtech COVID-19 vaccine).
15755766|NCT04811378|Other|HaemoCer|Randomized application of 3g haemostatic powder (HaemoCer) in the wound site during breast-conserving surgery.
15755767|NCT04811365|Other|Screening|After providing informed consent, relevant medical history data, and blood and buccal swab samples will be collected at a single visit from patients presenting with systemic mast cell activation symptoms
15755768|NCT04811339|Drug|open label BSS (pepto Bismol)|Pepto bismol (bismuth subsalicylate)
15755769|NCT04811326|Radiation|NB-UVB|radiation
15755770|NCT04811326|Drug|Latanoprost|eye drops
15755771|NCT04811313|Drug|Tranexamic acid|patients treated with TXA will have reduced blood loss and transfusion requirements compared with those who did not receive TXA
15755772|NCT04811313|Procedure|caudal epidural block|regional anesthesia in orthopedic procedures are known to help reduction of intraoperative blood loss
15755773|NCT04811313|Other|Placebo|participants will receive standard care but neither TXA nor caudal epidural block
15755774|NCT04811300|Other|There is no intervention|There is no intervention
15755775|NCT04811287|Device|Carpal Tunnel Release with Platelet-Rich Plasma|CTR is performed with adjuvant PRP placed intra-operatively.
15755776|NCT04811287|Procedure|Carpal Tunnel Release without Platelet-Rich Plasma|CTR is performed without adjuvant PRP placed intra-operatively.
15755777|NCT04811274|Biological|Blood collection|2 to 5 ml
15755778|NCT04811274|Biological|Bronchoalveolar lavage fluid collection|5 to 25 ml
15756023|NCT04809376|Drug|Pentosan Polysulfate Sodium|Subcutaneous Injection, 2mg/kg Ideal body Weight (IBW)
15755779|NCT04811261|Drug|Intravenous Infusion of UCLSCs|The first 3 subjects will be administered 50 x 10^6 ULSCs reconstituted in PBS with 1% human serum albumin in a volume of 250 ml, and monitored for adverse events or toxicities, immediately following dosing, and again at 30 days.
15755781|NCT04811235|Device|Near Infra-Red Spectroscopy (NIRS) Sensor|The NIRS sensor is laid on top of the dura, at the site of the SCI, and emits near-infrared light signals into the cord to measure tissue oxygenation and tissue hemodynamics in real-time.
15755782|NCT04811222|Diagnostic Test|Ga-DOTATATE PETMRI scan|Patients with AAA with minimum 2 years surveillance will have one time Ga-DOTATATE PETMRI scan
15755783|NCT04811209|Other|1.Baseline Measurements Before Surgery|"Baseline demographic data
~Baseline physiological variables (blood pressure, heart rate, respiratory rate, oxygen saturation)
~Baseline investigations (hemoglobin, coagulation profile, serum electrolytes) if appropriate.
~Preoperative pain state using NRS (0-10)
~Preoperative functional state using the QoR-15 questionnaire
~Pain expectation - patients will be asked preoperatively with the question In a scale from 0 to 10 (where 0 = no pain and 10 = worst pain imaginable), what do you consider is an acceptable pain score for your first (and second) day after surgery?... Two weeks after surgery?
~Pain castastrophizing scale"
15755784|NCT04811209|Other|2.Intraoperative Anesthetic Management|All study patients will be managed per routine clinical practice and institutional standard for the performed surgery.
15755785|NCT04811209|Other|3.Postoperative Analgesic Management|"postoperative pain will be managed on the ward using a multimodal analgesic regimen as appropriate. This includes:
~acetaminophen 650 - 1,000 mg given orally every 6 hours around the clock
~NSAIDs e.g., celecoxib or other agents given orally around the clock per clinical guideline; omit if contraindicated or per surgeon's preference
~Opioids e.g., hydromorphone 1-2 mg or oxycodone 15-30 mg given orally every 1-2 hours as required by the patient per standard nurse administered analgesic protocol.
~In the event of severe pain refractory to the above treatments, the patient will be offered IV opioid e.g., intermittent doses of 0.2-0.4 mg hydromorphone IV every 10 minutes until pain becomes tolerable"
15755786|NCT04811209|Other|4.Postoperative NRS Pain Assessment|Pain assessment using NRS pain scores (0 = no pain and 10 = worst possible pain) will be performed by an independent research staff, starting immediately in the PACU and serially over the first 48 hours after surgery or until hospital discharge.
15755787|NCT04811209|Other|5.Postoperative Global Rating Scale (GRS) Pain Assessment|Also, the degree of pain relief after treatment is assessed using a subjective 15-point Global Rating Scale (GRS) as mentioned above (Background). This is performed at the same time of each NRS assessment and a minimum of twice daily
15755788|NCT04811209|Other|6.Postoperative Patient Acceptable Symptom State (PASS) Assessment for Pain|"During each NRS pain assessment before or after an analgesic intervention on POD 0, 1 and 2, the patient will also be asked this question- In your opinion, do you consider your current pain state satisfactory after your operation? Patients giving a positive response are considered having an acceptable pain state. The PASS is the 75th centile for the pain NRS score in those with a satisfactory pain state."
15755789|NCT04811209|Other|7.Postoperative Quality of Recovery Assessment|The quality of recovery 15 questionnaire (QoR-15) to measure the dimension of quality of recovery will be administered once in the morning of POD 1 and POD 2. The MCID and PASS for QoR are determined in the same way as for NRS score. The final MCID value will be average of 4 values, 1 generated by the anchor based method and 3 generated by the distribution based method. The PASS for QoR is the 75th centile of the QoR-15 score in those patients who rated their recovery as good.
15755790|NCT04811209|Other|8.Other Postoperative Assessments|Additionally, opioid related adverse effects e.g., nausea, vomiting, itchiness, constipation, sedation (RASS + Ramsay)/ and respiratory depression will be assessed daily.
15755791|NCT04811196|Drug|Selinexor|Selinexor
15755792|NCT04811183|Behavioral|Pharmaceutical consultation|"Selection of patients for a pharmaceutical consultation with collection of non-opposition and scheduling of telephone interviews or by teleconsultations at one week after hospitalization.
~Data collection through interviews using a telephone questionnaire (or by teleconsultation) one week after consultation. Elements on knowledge and adherence of treatment will be collected."
15755793|NCT04811170|Other|Counselling|Participants with mild to moderate mood symptoms will receive a maximum of 6 counselling sessions and will be assessed at baseline (T0, W1), at post-treatment for counselling group (T1, W8), and after 2 booster sessions. Participants in the waiting list control group will receive the same counselling service after the counselling group completed the intervention. Participants with severe mood symptoms will receive a maximum of 10 counselling sessions and will be assessed at baseline (T0, W1), at post-treatment for counselling group (T1, W12), and after 2 booster sessions. Participants in the waiting list control group will receive the same counselling service after the counselling group completed the intervention.
15755794|NCT04811157|Dietary Supplement|Test product|200 g/day of unsweetened yogurt supplemented with a dietary fiber blend
15755795|NCT04811157|Dietary Supplement|Control product|200 g/day of unsweetened yogurt
15755796|NCT04811144|Device|Er:YAG dental laser|To treat Cavity, Sensitive Teeth, Abnormal Frenum Attachment and Peri-implantitis by using Er:YAG Dental Laser system which manufactured by LightMed Dental Technology Corp
15755797|NCT04811131|Drug|ARQ-252 cream 0.3%|ARQ-252 cream 0.3%
15755798|NCT04811131|Drug|ARQ-252 Vehicle cream|ARQ-252 Vehicle cream
15755799|NCT04811131|Device|NB-UVB phototherapy active treatment|NB-UVB phototherapy active treatment
15755800|NCT04811131|Device|NB-UVB phototherapy sham treatment|NB-UVB phototherapy sham treatment
15755801|NCT04811118|Drug|Docetaxel for Injection (Albumin-bound)|Docetaxel for Injection (Albumin-bound) by intravenous infusion
15755802|NCT04811118|Drug|Taxotere|Taxotere
15755803|NCT04811105|Procedure|steam ablation|32 rats have 1 fistula tract .For 16 rats the investigator will use steam ablation to obliterate and 16 rats will be control group
15755806|NCT04811079|Other|419 nm Spectacle Filter|TEST
15755807|NCT04811079|Other|437 nm Spectacle Filter|TEST
15755808|NCT04811079|Other|456 nm Spectacle Filter|TEST
15755809|NCT04811079|Other|476 nm Spectacle Filter|TEST
15755811|NCT04811066|Device|Transcranial direct current stimulation|"Transcranial electrical stimulation device. A weak direct electrical current, up to 2 mA, is passed between two electrodes placed on the scalp. Electrodes are housed in 35 cm2 sponges saturated with 4 ml of saline solution (0.9 % NaCl) per side, per pad.
~Stimulation is phased in with a 30-second ramp up of the electrical current to the specified stimulation parameters. Following the specified stimulation period, the current is phased-out with a ramp down of the current. For sham stimulation, the ramp-up and ramp-down periods are retained, but stimulation is switched off during the specified stimulation period."
15755812|NCT04811053|Drug|HR021618|Treatment group A: HR021618 injection
15755813|NCT04811053|Drug|Placebo|Treatment group B: Saline injection
15755818|NCT04811027|Drug|Eftilagimod alpha|APC activator, MHC II agonist, LAG-3 fusion protein
15755819|NCT04811027|Drug|Pembrolizumab|anti-PD-1 antibody
15755820|NCT04811014|Drug|Buprenorphine, Naloxone Drug Combination|8mg of buprenorphine/2mg of naloxone to initiate MOUD treatment and bridge, if necessary, until referral to MOUD clinic can be made for ongoing treatment
15755821|NCT04811014|Behavioral|Individual Counseling|One-on-one counseling with a licensed chemical dependency counselor
15755822|NCT04811014|Behavioral|Peer Recovery Support Services|24/7 support from our team of certified peer recovery support specialists to assist with emotional support and case management
15755823|NCT04811014|Behavioral|Support Group|Referrals to youth-focused support groups and eventual creation of in-house youth-focused support groups
15755824|NCT04811014|Behavioral|Referral to Medication Management|Study staff will refer patients to long-term MOUD providers in the community
15755825|NCT04811014|Behavioral|Assertive Outreach|The investigators will conduct weekly outreach to youths who experienced an opioid overdose and attempt to initiate treatment. Outreach is completed by a paramedic and peer coach.
15755826|NCT04811001|Drug|Osimertinib|TAGRISSO 40 mg film-coated tablets TAGRISSO 80 mg film-coated tablets
15755827|NCT04811001|Drug|Dacomitinib|Vizimpro 15 mg film-coated tablets Vizimpro 30 mg film-coated tablets Vizimpro 45 mg film-coated tablets
15755828|NCT04810988|Behavioral|Unified Protocol|The Unified Protocol is an empirically supported, transdiagnostic treatment for emotion disorders based on principles of cognitive behavioral therapy. Treatment focuses on increasing awareness of maladaptive thoughts and behaviors and decreasing avoidance of emotions and physiological sensations. Module 1 is focused on increasing motivation, readiness and self-efficacy for change. Module 2 focuses on increasing understanding and awareness of emotions. Module 3 is focused on further expanding awareness of emotions. Module 4 focuses on the role of thoughts in emotional disorders. Module 5 is focused on the role of behaviors in emotional disorders. Module 6 focuses on the role of physical sensations in emotional disorders. Module 7 focuses on exposure to interoceptive and situational triggers for emotions. Module 8 is focused on maintenance of treatment progress and relapse prevention.
15755829|NCT04810988|Behavioral|Therapist Support|4 video calls with study therapists
15755830|NCT04810975|Device|Muscle Strength Training|Strength training occurring specific exercise regimens using Exercise Equipment A or B
15755833|NCT04810949|Dietary Supplement|Vitamine D3 supplementation|1. The supplementation treatment will consist of prescribing vitamin D3 consumption of 4000 U 13 single dose tablets each month (52,000 IU).
15755834|NCT04810949|Dietary Supplement|Diet and sun exposure|"2. Hygienic-dietary recommendations will consist of 2 steps
~Sun exposure at least 10 minutes a day from 10: 00-6: 00 pm
~Consumption of foods rich in vitamin D: milk, fish, almonds, mushrooms"
15755835|NCT04810936|Dietary Supplement|oral nutritional supplements|Oral nutritional supplements is usually administrated to improve nutritional status in cancer patients.
15755836|NCT04810923|Procedure|i-PRF|intra-articular i-PRF injection after arthrocentesis
15755837|NCT04810923|Procedure|Arthrocentesis|Arthrocentesis procedure with 2 to 3 mL saline solution to lavage the superior compartment of temporomandibular joint.
15755838|NCT04810910|Biological|iNeo-Vac-P01|iNeo-Vac-P01 (peptides)： 300 mcg per peptide
15755839|NCT04810910|Other|GM-CSF|GM-CSF: 40 mcg
15755840|NCT04810897|Other|Exercise|Exercise programme is reported in the clinical trial registration number is NCT03473834.
15755841|NCT04810871|Procedure|Brain Surgery|Undergo surgery
15755842|NCT04810858|Device|Multimodal, multi-parametric MRI|The investigators will use multimodal, multi-parametric sequences to investigate neuroinflammatory and neurodegenerative processes in vivo. Participants will be assessed three times over 2 years.
15755843|NCT04810858|Other|Immune and cytokine profiling|Blood samples will be collected for immune and cytokine profiling. Participants will be assessed three times over 2 years.
15755844|NCT04810858|Behavioral|Neuropsychological testing|Participants will have neuropsychological testing three times over 2 years.
15755845|NCT04810845|Device|Application of Class II A device SmartCardia|Application of SmartCardia monitor patch 30 minutes before coronary angiography (2/3 devices per-patients would be applied). Non invasive recording of single-lead ECG, respiratory rate, pulse transit time, heart rate would occur pre, during and post (30 minutes) primary angioplasty procedure
15755846|NCT04810832|Other|Evoked related potentials|"Evoked related potentials are performed for each patient during each paradigm (neutral voice and expressive voices):
~with scalp electrodes in the department of neurophysiology
~with intracranial electrodes in the department of neurosurgery."
15755847|NCT04810819|Drug|Methylprednisolone 40 MG Injection;Dihydroxypropyltheophylline;|Before anesthesia induction, 80 mg methylprednisolone and 100 ml saline were given intravenously, and 0.25 g dihydroxypropyltheophylline and 100 ml normal saline were given intravenously.
15755848|NCT04810819|Drug|Placebo|Placebo
15755881|NCT04810572|Dietary Supplement|Composition with Silymarin|"Volunteers will receive supplementation for 90 days. They took 4 capsules daily. Two capsules in the morning and two capsules at night.
~There will be blood and feces collection at zero time, before supplementation, after 30 and 90 days from the beginning of supplementation."
15755849|NCT04810806|Procedure|Immediate coronary angiography within 2 hours after randomization|After achievement of informed consent in patients with NSTE-ACS complicated by ADHF, patients will be screened and randomized. Patients will be randomized to immediate CAG group or delayed CAG group. Immediate CAG group will receive CAG within 2 hours after randomization. Patients will receive treatment methods according to CAG results: percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or medical therapy only by operators' discretion.
15755850|NCT04810806|Procedure|Delayed coronary angiography after stabilization of heart failure|After achievement of informed consent in patients with NSTE-ACS complicated by ADHF, patients will be screened and randomized. Patients will be randomized to immediate CAG group or delayed CAG group. Delayed CAG group will receive CAG after stabilization of ADHF; improvement of symptoms and signs of heart failure. Patients will receive treatment methods according to CAG results: percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG) or medical therapy only by operators' discretion.
15755854|NCT04810780|Device|DUO Extended Set|to evaluate saftey and efficacy of DUO extended set combined with glucose sensor
15755855|NCT04810767|Other|Questionnaire|Pain experienced assessed by questionnaire described by Nikolajsen et al, 2004
15755856|NCT04810754|Drug|Daratumumab Injection|1800 mg per injection; 8 consecutive injections once a week; subcutaneous application in abdomen
15755857|NCT04810728|Drug|Extract Psidii guava|2 Capsule Extract Psidii guava, three times daily
15755858|NCT04810728|Combination Product|Standard therapy for Covid-19 patient|(Vitamin C, Zinc, medication for clinical symptoms such as: antipyretic agent, decongestan and mucolytic.)
15755859|NCT04810715|Other|Patients with Ankylosing Spondylitis|Observational study, not applicable
15755860|NCT04810702|Other|no intervention|no intervention
15755861|NCT04810689|Drug|Xuanfei Baidu Granules|Xuanfei Baidu granules is a prescription of 13 herbal medicinals made into dissolvable granules for oral intake
15755862|NCT04810689|Other|Placebo|Placebo for Xuanfei Baidu granule made into dissolvable granules for oral intake
15755863|NCT04810676|Drug|CKD-501, D745, D150|QD, PO
15755864|NCT04810676|Drug|CKD-383|QD, PO
15755865|NCT04810663|Radiation|Radiotherapy|Adjuvant Radiotherapy in operated gastric cancer
15755866|NCT04810650|Other|Mobile Travel Pack|"1) Access to a mobility coordinator who will assist with transfers, rescheduling, and out-of-facility refills; 2) Provision of a travel pack with alternative ART packaging options (e.g. ziplock bags, envelopes, pill boxes), a packing list and mobility coordinator phone contact for unplanned travel; 3) Screening at every clinic visit for planned mobility; 4) Mobile number and mobile minutes for unexpected travel; 5) Provision of longer refills (up to 6-months) for planned travel"
15755867|NCT04810650|Other|Alcohol Counselling|1) Two in-person alcohol counseling sessions with support from a clinical psychologist; 2) Monthly booster phone calls
15755868|NCT04810650|Other|Hypertension Linkage|1) Travel voucher (financial incentive) conditional on linkage to hypertensive care; 2) Phone call reminders for missed visits
15755869|NCT04810650|Other|PrEP/PEP at Outpatient Clinics|Intervention delivered at Outpatient Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services
15755870|NCT04810650|Other|PrEP/PEP at Antenatal/FP Clinics|Intervention delivered at Antenatal/FP Clinics: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services
15755871|NCT04810650|Other|PrEP/PEP at Households|Intervention delivered in community by village health team: Counseling and education on and choice between prevention modalities (e.g. PrEP, PEP, condoms), choice of service location, provision of a clinical officer's or nurse's mobile telephone number for immediate PEP starts any day of the week, routine assessment of barriers to initiation or adherence to PrEP/PEP, including the offer of personalized potential solutions such as choice of in-clinic or offsite service delivery, psychologic supports for traumatic experiences, and offer of concurrent, additional health or prevention related services
15755872|NCT04810650|Other|Youth Hubs|Youth Hubs setting will integrate an HIV health curriculum into the routine meetings. A standard life-skills curriculum and activities to attract participation in the clubs will be augmented with additional units related to PrEP, PEP and HIV prevention and treatment.
15755873|NCT04810650|Other|Standard of Care|HIV prevention and treatment standard of care
15755874|NCT04810637|Drug|GX-I7|Recombinant human interleukin-7 hybrid Fc
15755875|NCT04810624|Behavioral|Relapse Prevention and Changing Habits +|Psychotherapy
15755876|NCT04810611|Drug|MBG453|Anti-TIM3 monoclonal antibody
15755877|NCT04810611|Drug|NIS793|Anti-TGF-β monoclonal antibody
15755878|NCT04810611|Drug|canakinumab|Anti-IL-1β monoclonal antibody
15755879|NCT04810598|Drug|Venetoclax|Oral Tablet
15755880|NCT04810585|Drug|Aflibercept + FOLFIRI|"Day 1. Aflibercept + FOLFIRI
~aflibercept(Zaltrap): 4 mg/kg IV infusion for over 1hr (Do not administer as an IV push or bolus)
~Folinic acid: 400 mg/m2 IV infusion for over 2 hours
~Irinotecan: 150 mg/m2 IV infusion for over 1 hours
~5-FU: 400 mg/m2 IV bolus injection for over 5 minute
~5-FU: 2400 mg/m2 IV continuous infusion for 46 hours every 2 weeks until progression disease or death or unacceptable toxicity"
15755944|NCT04810039|Other|Predict the outcome of the Glasgow Outcome Scale|Predict the outcome of the Glasgow Outcome Scale (GOS) score at 6 months compared to the actual outcome, in 20 anonymized records.
15755882|NCT04810572|Dietary Supplement|Low-mineral composition without Silymarin|"Volunteers will receive supplementation for 90 days. They took 4 capsules daily. Two capsules in the morning and two capsules at night.
~There will be blood and feces collection at zero time, before supplementation, after 30 and 90 days from the beginning of supplementation."
15755883|NCT04810559|Device|OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test|OraQuick ADVANCE® HIV-1/2 Rapid Antibody Test in oral fluid and fingerstick blood conducted by untrained healthcare providers compared to laboratory 4th generation Ag/Ab EIA results performed on venous blood.
15755884|NCT04810546|Dietary Supplement|Jarrow Formulas Oral Bovine Lactoferrin Supplement|Lactoferrin (Apolactoferrin) 250mg contains ~17.6 mg/100g of iron
15755885|NCT04810533|Drug|[14C] SH-1028|Volunteer will receive a single oral dose of 200 mg/88 uCi [14C]SH-1028 as a solution on Day 1
15755886|NCT04810520|Other|Point-of-care ultrasound with tele-supervision|Point-of-care ultrasound of critically ill patients (acute dyspnoea, circulatory failure, trauma) will be performed with tele-supervision.
15755887|NCT04810520|Other|Point-of-care ultrasound without tele-supervision|Point-of-care ultrasound of critically ill patients (acute dyspnoea, circulatory failure, trauma) will be performed with tele-supervision.
15755888|NCT04810507|Drug|Anagliptin BID Treatment|Continuous Glucose Monitoring with Anagliptin 100mg BID or Sitagliptin 100mg QD treatment for 12 weeks
15755889|NCT04810494|Drug|2% Lidocaine HCl topical solution|0.5mL of 2% Lidocaine will be administered intranasally in each nostril with a mucosal atomization device.
15755890|NCT04810494|Drug|0.9% Sodium chloride|0.5mL of 0.9% Sodium chloride (normal saline) will be administered intranasally in each nostril with a mucosal atomization device.
15755891|NCT04810481|Device|BIS Complete Monitoring System|The BIS™ complete monitoring system is a user-configurable patient monitoring system designed to monitor the hypnotic state of the brain based on the acquisition and processing of EEG signals. The BIS™ complete system processes raw EEG signals to produce a single number, called the BIS™ index, which correlates with the patient's level of hypnosis. A sensor placed on the patient's head transmits EEG signals to the BISx™ unit. The BISx™ unit filters and digitizes the signal, analyzes it for the artifact, and processes it using digital signal processing techniques to derive processed EEG parameters to a single Bispectral Index (BIS™), and finally sends the processed data to the monitor for display. The purpose of processing the EEG waveform data is to extract characteristic features from the complex signal that the BIS™ algorithm can utilize to derive BIS Index.
15755892|NCT04810468|Other|Anthropometric measurment|Anthropometric measurment used to asses the wheight in kelogram and asses height in cetemeter and also asses BMI
15755893|NCT04810455|Other|Purrble|"The objective of this study is to evaluate the impact of having access to the Purrble intervention, compared to an active control in the form of a non-interactive plush toy, on child daily emotion regulation (primary outcome) as well as a range of secondary outcomes over a period of one month.
~The investigators hypothesise that engagement with an in-situ, 'bottom-up' emotion regulation intervention which enables in-the-moment soothing for children, will lead to measurable changes in child self-regulatory behaviours over time."
15755894|NCT04810455|Other|Active control toy|The selected active control toy is the Wild Republic 8'' Hedgehog animal. The selection process was guided by: the plush toy needed to have analogous size, weight, quality of materials, and at least similar (if not higher) visual appeal. The investigators also made sure to include the design characteristics our prior work suggested were important for the narrative around the toy. These were selecting a similarly stylised animal (to enable emotion projection and feelings of care), as well as no visible mouth on the toy (to prevent setting an expectation about the toy's emotional state as a mouth would imply an emotional expression). Additionally, the investigators have adapted the one-page parent-facing descriptions of the narrative that come with Purrble also for the active control unit: as such, the active control families will receive the same general narrative-without the explicit mentions of the toy interactivity-and the same suggested activities for parents.
15755895|NCT04810442|Other|Nap|45-minute nap between scanning procedures
15755896|NCT04810429|Drug|Incobotulinumoxin A|"XEOMIN® (incobotulinumtoxinA) is an approved medication that inhibits the release of acetylcholine and muscle blockage. Xeomin is indicated for the symptomatic treatment of blepharospasm and hemifacial spasm, cervical dystonia of a predominantly rotational type (spasmodic torticollis), spasticity of the upper limbs and chronic sialorrhea due to neurological changes. Xeomin comes as a white powder for solution for injection. When dissolved Xeomin is a clear, colorless solution that does not contain particles. Xeomin is reconstituted before use with sterile sodium chloride 9 mg / ml (0.9%) solution, without preservatives, for injections.
~The active substance is Clostridium botulinum type A neurotoxin (150 kD), without complexing proteins. The other components are human albumin and sucrose."
15755897|NCT04810429|Procedure|TMJ surgical arthroscopy|TMJ arthroscopy is a minimal invasive surgical technique for different types of temporomandibular joint (TMJ) internal derangements. Besides the acceptable outcomes of TMJ arthroscopy, the authors believe that adding to this treatment a single injection of BTXA into the temporalis and masseter muscles could reduce joint loading, improving TMJ arthroscopic results.
15755898|NCT04810416|Other|Texting- 10 minutes|Participants will practice texting for 10 minutes using smart phone.
15755899|NCT04810416|Other|Writing- 10 minutes|Participants will practice writing on notebook for 10 minutes.
15755900|NCT04810416|Other|Texting- 15 minutes|Participants will practice texting for 15 minutes using smart phone.
15755901|NCT04810416|Other|Writing- 15 minutes|Participants will practice writing on notebook for 15 minutes.
15755902|NCT04810403|Behavioral|SOMEBODY Eating Disorder Prevention Program|Participants will receive daily activities to complete on their most frequently used social media platform for 14 consecutive days. Daily activities have been adapted from the Body Project - an intervention that has been demonstrated to reduce internalization of the thin ideal and reduce risk for eating disorders. Examples of activities to be piloted include unfollowing social media accounts the participant perceives as reinforcing the thin-ideal and posting a selfie without makeup or editing. Based on feedback from participants, the intervention may be altered to improve acceptability, feasibility, and preliminary evidence of potential efficacy.
15755945|NCT04810026|Behavioral|Education|Healthy-lifestyle and diabetes-related virtual education (text and videos)
15756024|NCT04809376|Drug|Placebo (Sodium Chloride Injection, 0.9%)|Placebo to match PPS
15755905|NCT04810377|Procedure|EUS-guided gastroenterostomy|First after an upper endoscopy is performed, a catheters passed throughout the endoscope channel and with x-ray verification, a guide wire is passed up to the third portion of duodenal loop. then small intestinal is filled with saline solution up to 1500cc and contrast solution. Then an endoscopic ultrasound examination will be carried out where a loop of the small intestine that is located less than 2 cm apart from the gastric wall will be looked for. Once the intestinal loop is identified a direct antegrade puncture will be performed with a luminal apposition prosthesis release system . Finally, correct position is verified with x-ray and we will look for any misplacement or leakage during this process or the presence of bleeding. Endoscopic treatment will be performed if necessary. Subsequently, the participants will go to monthly follow-up with clinical evaluation, laboratory and radiological test will be carried out until the participants dies.
15755906|NCT04810364|Radiation|Quantitative coronary angiography, intravascular imaging with percutaneous intervention|Coronaries will be shot with AXIOM Artis dFC (Siemens, Munich,Germany) or systems from any other vendors. In case if necessary the procedure will be delayed for intravascular imaging (OCT, IVUS, VH-IVUS, NIRS) and/ or percutaneous intervention (with implantation of the medical device).
15755907|NCT04810351|Other|observational study|There is no intervention. It is an observational study
15755908|NCT04810312|Other|Combined exercise and nutrition intervention|Back extensor strengthening exercise and nutritional supplementation for 12 weeks
15755909|NCT04810299|Other|Aromatherapy|Aromatherapy; It is one of the complementary therapy methods defined as the therapeutic use of essential oils obtained from parts of plants such as root, seed, leaf, flower, shell with appropriate methods.
15755910|NCT04810299|Other|Classical foot massage|Classical foot massage; It is defined as a massage technique based on the principle of systematic relaxation
15755911|NCT04810286|Procedure|3d-Printing Myofunctional Appliance|To evaluate soft- and hard-tissue changes Class II division 1 tchildren with a prefabricated myofunctional appliance versus a 3D-printed myofunctional appliance.
15755912|NCT04810273|Behavioral|Early mobilization|The goal will be to achieve a mobilization level of at least Level III (sitting on the edge of bed) during the ICU stay.
15755913|NCT04810260|Behavioral|Use mobile health app (WellXcel) to increase knowledge|Download the app (WellXcel) to the mobile device
15755914|NCT04810247|Behavioral|Body Project|The Body project is a dissonance based intervention designed to target negative body image among adolescent females. The intervention is delivered in small groups of 5-10 individuals over 4, one-hour group sessions. This program will be iteratively revised.
15755915|NCT04810234|Device|transcutaneous vagal nerve stimulation (tVNS)|Cervical and auricular transcutaneous stimulation of the vagus nerve
15755916|NCT04810221|Device|BrOxy M device|Measure of SpO2 and Heart Rate by BrOxy M device in a controlled desaturation study.
15755917|NCT04810208|Drug|Docetaxel|Docetaxel in NanoZolid formulation, for intratumoural injection
15755918|NCT04810195|Device|Boston Scientific Acurate neo2 TAVR device|The newest generation of the Acurate neo2 TAVR device, launched in Europe in 2020.
15755919|NCT04810182|Drug|Regorafenib 40 MG Oral Tablet [STIVARGA]|As per the treating physicians discretion
15755920|NCT04810169|Device|Smart inhaler|"Automatic record (number of actuations and their timing) of the use of the emergency treatment through the smart inhaler
~Questionnaire sent to the parents at each use of the smart inhaler to get information regarding the reason of use and the efficacy of the treatment given"
15755921|NCT04810156|Drug|Mycophenolate Mofetil|Day 1: MMF 500 mg twice a day Day 2: MMF 1000 mg twice a day
15755922|NCT04810156|Drug|Tacrolimus|Day 1: Tacrolimus 1 mg twice a day Day 2-5: Tacrolimus 3 mg twice a day From day 6 and onwards: Dose adjustment according to trough level
15755923|NCT04810156|Drug|Solu-Medrol|2 mg/kg/day
15755924|NCT04810156|Drug|Ursodeoxycholic acid|Patients with mixed or cholestatic liver injury pattern will also be administrated peroral UDCA
15755925|NCT04810143|Device|Mitra Microsampler|an FDA Class I medical device for direct specimen collection of blood or other biological fluids
15755926|NCT04810130|Other|Soccer Kicking|Subjects assigned to the soccer kicking arm will complete 10 soccer kicks in 10 minutes.
15755927|NCT04810130|Other|Soccer Heading (Frontal)|Subjects assigned to the soccer heading (frontal) arm will complete 10 frontal soccer headers (ball headed directly back to launch direction) in 10 minutes. Soccer balls will be projected at 10-17.5 m/s from approximately 10-15 m with a JUGS ball launcher.
15755928|NCT04810130|Other|Soccer Heading (Oblique)|Subjects assigned to the soccer heading (oblique) arm will complete 10 oblique soccer headers (ball headed 90° to the right from ball launch direction) in 10 minutes. Soccer balls will be projected at 10-17.5 m/s from approximately 10-15 m with a JUGS ball launcher.
15755929|NCT04810117|Diagnostic Test|Serodiagnosis of IgG and IgM|IgG and IgM antibodies will be detected in COVID-19 patients
15755930|NCT04810104|Drug|AZD0328|Active study drug
15755931|NCT04810104|Drug|Placebo|Non-active study drug
15755932|NCT04810091|Drug|Placebo Administration|Given PO
15755933|NCT04810091|Other|Questionnaire Administration|Ancillary studies
15755934|NCT04810091|Drug|Telotristat Ethyl|Given PO
15755935|NCT04810078|Biological|Nivolumab and rHuPH20|Specified dose on specified days
15755936|NCT04810078|Biological|Nivolumab|Specified dose on specified days
15755937|NCT04810065|Other|SingStrong: Strong lungs through Song|"Participants who have been clinically diagnosed with Covid-19 and who continue to suffer residual adverse effects on the lung health will be invited to participate in the study.
~The intervention will involve biweekly hour-long breathing and singing classes that are designed to correct dis-ordered breathing, and retrain the principal muscles of respiration.
~Pre and post evaluation of participant bio-psychosocial health and wellness will be conducted. Triangulation of data using focus groups and individual interviews will be conducted after conclusion of the intervention,"
15755938|NCT04810052|Behavioral|Behavioral Intervention|Perform 1 nice thing
15755939|NCT04810052|Behavioral|Behavioral Intervention|Write a letter or note of gratitude
15755940|NCT04810052|Behavioral|Behavioral Intervention|Track daily activities
15755941|NCT04810052|Other|Interview|Ancillary studies
15755942|NCT04810052|Other|Quality-of-Life Assessment|Ancillary studies
15755943|NCT04810052|Other|Questionnaire Administration|Ancillary studies
15755946|NCT04810026|Behavioral|Meal delivery|breakfast, lunch, and dinner adhering to the longevity diet macro-nutrient profiles
15755947|NCT04810026|Behavioral|Lifestyle coaching|calls with coach and/or nutritionist, access to Facebook community support group
15755948|NCT04810013|Procedure|non-invasive measurement of cerebral autoregulation|Non-invasive measurement of the cerebral autoregulation in the postoperative period in 80 neonates and infants with complex congenital heart disease undergoing cardiopulmonary bypass surgery. A continuous, moving Pearson's correlation coefficient will be calculated between the arterial pressure and near-infrared spectroscopy signals and displayed continuously during surgery using a laptop computer and the ICM+ software (Cambridge Enterprise).
15755949|NCT04810000|Device|tourniquet|Tourniquet release before/after wound closure
15755950|NCT04809987|Other|Virtual Gait|The subject will be stand up with a standing opposite a mirror (from the waist up) and a screen (from the waist down) where a video of treadmill gait of a person will be projected.
15755951|NCT04809987|Other|Physical Exercise|Specific gait exercise was conducted.
15755952|NCT04809987|Other|Documental projection|The subject will be stand up with a standing opposite a mirror (from the waist up) and a screen (from the waist down) where video without any type of animal or human movement was showed.
15755953|NCT04809974|Drug|Niagen|The intervention consists of taking Niagen and completing all tasks divided into 6 visits.
15755954|NCT04809961|Other|I-care app|A smart phone app to enable healthcare worker peer support for improved workplace wellbeing.
15755955|NCT04809948|Biological|viral vector vaccine|AstraZeneca vaccine
15755956|NCT04809935|Drug|98% dehydrated alcohol|"coeliac plexus is identified and punctured
~Injection of 10 mL of .25% bupivacaine, followed by 10 mL of 98% dehydrated alcohol."
15755957|NCT04809935|Device|19G EUSRA needle, Taewoong Medical, Korea|"10W-30W RFA will be applied unilaterally or bilaterally depends on individual anatomical characteristics for 10-50s
~Complete ablation of coeliac plexus nervous tissue is confirmed by appearance of air-bubble ultrasound scan"
15755959|NCT04809909|Procedure|Peripheral stimulation of acupuncture points (PSAP)|Electrode leads will be implanted at Bladder 25-bilateral (BL25), the acupoint commonly used for relief of chronic Low Back Pain in standardized acupuncture.
15755960|NCT04809909|Procedure|Peripheral nerve field stimulation (PNFS)|Electrode leads will be implanted at the region of pain.
15755961|NCT04809883|Diagnostic Test|Endoflip measurement of gastric and pyloric function|Endoflip device to measure gastric and pyloric functions
15755962|NCT04809870|Procedure|surgery|retrospective comparison of esophagectomy for esophageal cancer in patients with or without concomitant liver cirrhosis
15755963|NCT04809857|Other|Exercise|
15755964|NCT04809844|Other|Concurrent chemoradiation|concurrent Paclitaxel and radiation therapy after Adjuvant doxorubicin and Cyclophosphamide chemotherapy for stage ll or lll breast cancer .
15755965|NCT04809831|Other|Domiciliary oral care with Biorepair Peribioma Toothpaste + Mousse|Patients will use Biorepair Peribioma Toothpaste and Mousse for domiciliary oral hygiene twice a day until T2 session.
15755966|NCT04809831|Other|Domiciliary oral care with Curasept Toothpaste (chlorhexidine 0,2%)|Patients will use Curasept Toothpaste (chlorhexidine 0,2%) for domiciliary oral hygiene twice a day until T2 session.
15755967|NCT04809818|Drug|LT3001 drug product|Multiple doses of LT3001 drug product administered by intravenous infusion
15755968|NCT04809818|Drug|Placebo|Multiple doses of Placebo administered by intravenous infusion
15755969|NCT04809818|Drug|Aspirin|Loading and maintenance doses of Aspirin administered by oral
15755970|NCT04809818|Drug|Clopidogrel|Loading and maintenance doses of Clopidogrel administered by oral
15755971|NCT04809818|Drug|Apixaban|Multiple doses of Apixaban administered by oral
15755972|NCT04809818|Drug|Dabigatran|Multiple doses of Dabigatran administered by oral
15755974|NCT04809792|Radiation|SBRT on the MR-Linac|Radiotherapy is performed on the 1.5 T MR Linac
15755975|NCT04809779|Drug|Sintilimab|The PD-1 inhibitor Sintilimab 200mg for intravenous (IV) administration will be given together with three-week epirubincin, cyclophosphamide (EC) × 4 treatments from the second cycle followed by weekly nab-paclitaxel x12 treatments or three-week nab-paclitaxel x4 treatments.
15755979|NCT04809753|Device|Eustachian tube dilation|Dilation of the eustachian tube with an endovascular balloon
15755980|NCT04809740|Other|evaluate implementation of navigator-delivered Home ePRO for all cancer patients|evaluate implementation of navigator-delivered Home ePRO for all cancer patients across multiple practice sites; 2) examine the barriers, facilitators, and implementation strategies used in implementing navigator-delivered Home ePRO; and 3) assess the impact of Home ePRO on clinical and utilization outcomes
15755981|NCT04809727|Procedure|Cervical biopsy|4 quadrant biopsy
15755982|NCT04809714|Device|Blood Flow Restriction with Delfi Tourniquet System Cuff|Postoperative rehabilitation will occur up to twice a day for 5 days a week for 2 weeks using a Delfi tourniquet system blood pressure cuff with a limb occlusion pressure (LOP) of 60-100%. For each physical therapy session, participants will undergo therapy following a standardized protocol of 3-5 difference exercises each with 4 sets total in addition to NMES.
15755983|NCT04809714|Other|Routine Post-operative Physical Therapy|The control group with undergo a post-op therapy protocol that mirrors that of the intervention group except that they will use a Delfi tourniquet system blood pressure cuff with a limb occlusion pressure (LOP) of only 10%. Participants will use a neuromuscular electrical stimulation device operating at a sub-therapeutic level.
15755984|NCT04809701|Procedure|Temporary implantation of defibrillation coils and pulse generator|Each subject will undergo temporary implantation of defibrillation coils and pulse generator according to the NV-ICD electrode configurations.
15755985|NCT04809701|Procedure|Defibrillation following induction of VA (Configuration A first)|Ventricular arrhythmia (VA) will be induced via an EP catheter placed in the right ventricle. After VA is confirmed, a defibrillation shock will be attempted to terminate the arrhythmia. Up to two defibrillation energies will be tested for Configuration A. Then up to two defibrillation energies will be tested for Configuration B.
15755986|NCT04809701|Procedure|Defibrillation following induction of VA (Configuration B first)|Ventricular arrhythmia (VA) will be induced via an EP catheter placed in the right ventricle. After VA is confirmed, a defibrillation shock will be attempted to terminate the arrhythmia. Up to two defibrillation energies will be tested for Configuration B. Then up to two defibrillation energies will be tested for Configuration A.
15755987|NCT04809701|Procedure|Removal of defibrillation coils and pulse generator|Defibrillation coils and pulse generator will be removed from the subject after the defibrillation tests are completed.
15755988|NCT04809688|Dietary Supplement|Saskatoon berry|Freeze dried Saskatoon berry (30 g) will be orally administrated daily for 10 weeks.
15755989|NCT04809675|Device|Hard occlusal splint|Use of a hard occlusal splint at times they considered helpful.
15755990|NCT04809675|Device|Flexible customized mouthguard|Use of a flexible customized mouthguard at times they considered helpful.
15755991|NCT04809662|Drug|Imiquimod|"Patients with a diagnosis of actinic keratosis or warts that would be prescribed imiquimod as standard of care will be asked to apply 2 packets (or 2 full pumps) of imiquimod once daily before bedtime for two weeks and then leave on overnight for ~8 hours.
~(a) A biopsy will be performed at the baseline visit on the pre-treatment skin and the skin where the medication will not be applied. The skin where the medication will not be applied will act as the negative control. A biopsy will then again be performed on day 10 of imiquimod treatment on the treated skin only, where the study drug was applied."
15755992|NCT04809649|Drug|SUBA-itraconazole|Participant will receive treatment with SUBA-itraconazole
15755993|NCT04809636|Other|This is not an interventional study|While this is not an intervention, there will be separate participants for the survey study and for the other components of the study (focus groups, interviews, conjoint analysis, piloting the vignettes
15755996|NCT04809610|Behavioral|Internet attachment-based compassion therapy (iABCT).|The iABCT is a self-applied program based on the attachment theory and the use of compassion meditations. It is composed of 8 modules that have been reformulated to be completely self-applied and include text, images, illustrations, videos, audio with guided meditations, exercises and homework. Downloadable PDF files will be made available so that users can review them offline. Each module has been optimized to have a duration of 60 and 90 minutes approximately. The entire intervention is estimated to be completed in eight weeks.
15755997|NCT04809584|Drug|F18-DCFPyL|Participant will be injected iv with 9 mCi ± 20% of 18F-DCFPyL
15755998|NCT04809584|Drug|Gadolinium|Contrast agent
15755999|NCT04809584|Procedure|Positron emission tomography (PET)/Magnetic Resonance Imaging (MRI) Scan|Imaging test that combines PET (positron emission tomography) and MRI (magnetic resonance imaging)
15756000|NCT04809571|Other|Photoacoustic imaging and Confocal Raman spectroscopy measurement|All subjects will first have their basic history and clinical measurements taken, followed by skin physiology measurements and photoacoustic mesoscopic imaging as well as confocal Raman spectroscopy measurements.
15756001|NCT04809558|Behavioral|Tongue resistance exercise|Participant will complete tongue resistance exercises.
15756002|NCT04809545|Other|Acusticare|Acusticare is an internet connected speaker which delivers an environmental intervention by playing sounds to adjust the soundscape in the room.
15756003|NCT04809545|Other|Treatment as usual|Usual care provided on the Specialized Dementia Unit
15756004|NCT04809532|Procedure|Transverse abdominis plane (TAP) block|Ultrasound guide bilateral TAP block at end of cesarean section
15756005|NCT04809532|Drug|Bupivacain|20ml 0.25% bupvicaine
15756006|NCT04809532|Drug|Tramadol|intravenous tramadol
15756007|NCT04809519|Other|Integrative Nursing based Multimodal Interventions for Uncontrolled Hypertensives|In this study, multimodal interventions including yoga, meditation, and breathing techniques, compliance training for hypertension treatment, and home blood pressure measurement training will be applied to the experimental group.
15756008|NCT04809519|Other|Ongoing treatment|The ongoing health service of the control group will continue. In addition, the control group will be directed to a specialist doctor and standard brochures prepared by the Ministry of Health for hypertensive individuals will be given.
15756009|NCT04809506|Biological|additional blood samples|2 additional blood samples (2 x 7ml) at every visit
15756010|NCT04809493|Procedure|Conventional dialysis treatment|Conventional dialysis treatment
15756011|NCT04809493|Procedure|Isonatremic dialysis treatment|Isonatremic dialysis treatment
15756012|NCT04809480|Diagnostic Test|Fungal rhinosinusitis|Pathology examination
15756013|NCT04809467|Drug|tafasitamab|tafasitamab will be administered at a protocol defined dose once a week for cycles 1-3 and every other week from cycle 4 until progression.
15756014|NCT04809467|Drug|parsaclisib|parsaclisib will be administered at protocol defined dose for cycles 1 through disease progression.
15756015|NCT04809441|Other|Diet change|A specific very low-calorie diet (<800kcal/day), and 2 daily sessions of 15 minutes of anaerobic physical exercise depending on the capacity of the participants, were designed
15756016|NCT04809428|Procedure|vNOTES salpingectomy|Surgical removal of both salpinx by vNOTES with using a 3-cm of posterior colpotomy and either glove port or Gel point V path. Colpotomy will be closed with using 2.0 rapid vicryl.
15756017|NCT04809428|Procedure|Laparoscopic salpingectomy|Surgical removal of both salpinx by conventional laparoscopy in a standardised fashion: with using one 10-mm umbilical and two 5-mm lateral ports.
15756018|NCT04809415|Other|Photobiomodulation|Photobiomodulation consists of irradiation by light in order to achieve photochemical and photophysical outcomes.
15756019|NCT04809415|Other|Sham|Simulation of the application of photobiomodulation therapy.
15756020|NCT04809402|Other|remote monitoring after cataract surgery|remote monitoring after cataract surgery
15756021|NCT04809389|Biological|DelNS1-nCoV-RBD LAIV|Genetically engineered live attenuated influenza virus to express the receptor binding domain of SARS-CoV-2's spike protein for triggering human body's immune responses against SARS-CoV-2
15756025|NCT04809376|Drug|Pentosan Polysulfate Sodium Fixed Dose|Subcutaneous Injection, 100/150 mg if ≤65/>65 kg IBW
15756026|NCT04809363|Other|CDPATH™|Crohn's disease risk prediction tool.
15756027|NCT04809363|Other|Blood Draw|Three blood samples will be drawn.
15756028|NCT04809350|Dietary Supplement|Adjustable Human Milk Fortification|"BUN and sodium concentrations will be measured every week in infants on full enteral feeds with fortified human milk.
~Liquid protein will be added based on serum urea."
15756029|NCT04809350|Dietary Supplement|Targeted Human Milk Fortification|"Human milk will be analyzed twice weekly. Before the day of analysis, each mother will store fresh milk pumped from 10:00 AM until 8:00 AM of the previous day in a refrigerator and bring it to the hospital.
~Protein, fat, and sodium supplementation will be added to the human milk to meet the recommended daily intakes."
15756030|NCT04809337|Other|Exercise|After manuel therapy, the patients were allocated into two groups as Stabilization Exercise Group and Therapeutic Exercise Group randomly.
15756031|NCT04809324|Procedure|Gross examination of the resection specimen|measurement of the surgical margin by the operating surgeon using sterile scale, margins <7mm will be revised on table
15756032|NCT04809324|Procedure|Frozen section|frozen section evaluation of the specimen by the pathologist
15756033|NCT04809311|Other|Lifestyle|"During the study, no medical drugs will be supplied to the patients. Patients will continue their antidiabetic treatment independently of this study and at the treating physician's discretion as part of usual clinical practice.
~Approximately 12-week study duration"
15756034|NCT04809311|Drug|Oral antidiabetetic drugs|"During the study, no medical drugs will be supplied to the patients. Patients will continue their antidiabetic treatment independently of this study and at the treating physician's discretion as part of usual clinical practice.
~Approximately 12-week study duration"
15756035|NCT04809311|Drug|Basal insulin|"During the study, no medical drugs will be supplied to the patients. Patients will continue their antidiabetic treatment independently of this study and at the treating physician's discretion as part of usual clinical practice.
~Approximately 12-week study duration"
15756036|NCT04809311|Drug|Glucagon-like peptide-1 (GLP-1)|"During the study, no medical drugs will be supplied to the patients. Patients will continue their antidiabetic treatment independently of this study and at the treating physician's discretion as part of usual clinical practice.
~Approximately 12-week study duration"
15756037|NCT04809311|Drug|Premixed insulin|"During the study, no medical drugs will be supplied to the patients. Patients will continue their antidiabetic treatment independently of this study and at the treating physician's discretion as part of usual clinical practice.
~Approximately 12-week study duration"
15756038|NCT04809298|Device|Free-hand therapeutic CT-guided punction for lumbar pain|Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the Puncture Cube® as a needle navigation device.
15756039|NCT04809298|Device|Puncture Cube|Diagnostic or therapeutic CT-guided intervention for lumbar pain management using the Puncture Cube® as a needle navigation device.
15756041|NCT04809272|Behavioral|ParentChat for parents of children ages 2-17|The programme will include text/audio messages, illustrated comics, videos, and activity assignments for parents to do with their children. Parents will be prompted to give feedback regarding successes and challenges applying these parenting skills via audio or text messages during the week.
15756042|NCT04809259|Device|Isothermal pouch|The study will verify it the use of an isothermal pouch to maintain the content of an elastomeric pump at 10° to 15°C avoids unacceptable meropenem degradation over the 24 hour infusion period.
15756043|NCT04809246|Other|'One-stop-shop' hepatitis clinic|Establishment of a 'one-stop-shop' hepatitis clinic, integrating point-of-care HCV RNA testing, followed by clinical assessment, non-invasive liver fibrosis assessment by fibro-elastography (Fibroscan), and early DAA prescription (for those with chronic HCV) followed by linkage to ongoing hepatitis care, all in the same 60-minute visit.
15756044|NCT04809233|Drug|Tipifarnib|
15756045|NCT04809220|Drug|Dulaglutide|Administered SC
15756046|NCT04809220|Drug|Biguanide (BG)|Administered orally
15756047|NCT04809220|Drug|Sulfonylurea (SU)|Pre-administered orally
15756048|NCT04809220|Drug|Alpha-Glucosidase Inhibitors (α-GI)|Pre-administered orally
15756049|NCT04809220|Drug|Thiazolidinedione (TZD)|Pre-administered orally
15756050|NCT04809220|Drug|Glinides (GLN)|Pre-administered orally
15756051|NCT04809220|Drug|Sodium-glucose cotransporter type 2 inhibitors (SGLT2i)|Pre-administered orally
15756052|NCT04809207|Other|CF Wellness Program Sessions|The intervention will last approximately 12 weeks. During this time, up to 9 coaching sessions will be delivered. Each will last approximately 45 - 60 minutes. Sessions will be delivered either by web-based video chat (e.g., Zoom) or by telephone. Sessions will cover content such as understanding the physiological, cognitive, affective, behavioral contributors to CF fatigue; understanding the role of physical activity/exercise and fatigue including the importance of balancing activity and rest periods; cognitive restructuring; addressing attention and interpretation processes contributing to fatigue; teaching techniques such as mindfulness meditation relaxation strategies, good sleep hygiene, and activity scheduling and behavioral activation; and engaging social support. Physical activity goals will be set each session. Participants will be encouraged to use the provided fitness tracker and to sync weekly prior the coaching session so that the results can inform session content.
15756053|NCT04809181|Drug|Azacitidine in Combination With Venetoclax|Azacitidine in combination with venetoclax
15756054|NCT04809168|Other|Questionnaires and inventories|questionnaires and inventories related to primary end secondary outcomes will be applied and physical examination will be performed.
15756055|NCT04809155|Behavioral|Girl2Girl|The program has a 'core' 7 weeks of daily messages and then a week 'booster' that is delivered 3 months later.
15756056|NCT04809142|Drug|TQB2450 Injection|TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle.
15756057|NCT04809142|Drug|Anlotinib hydrochloride|Anlotinib capsules 12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
15756058|NCT04809142|Drug|Oxaliplatin injection|Oxaliplatin injection 130 mg/m2 administered IV on Day 1 of each week in 3-week cycles;
15756059|NCT04809142|Drug|Capecitabine tablets|Capecitabine tablets total dose 2000 mg/m2, oral twice a day from Day 1-14 of each 3- week cycles;
15756060|NCT04809142|Drug|Gemcitabine hydrochloride injection|Gemcitabine hydrochloride injection administered 1000 mg/m2 IV on Day 1 and Day 8 of each week in 3-week cycles.
15756061|NCT04809129|Device|Weighted vest|Patients will wear a weighted vest following bariatric surgery with weight increased incrementally to maintain baseline weight. This vest will be worn for a minimum of 8 hours a day for three months postoperatively.
15756062|NCT04809116|Drug|Pimavanserin|open-label, fixed-dose pimavanserin 34mg at bedtime for 6 weeks
15756063|NCT04809103|Drug|cis-diamminedichloroplatinum|Cisplatin delivered bronchoscopically at the time of diagnosis of NSCLC
15756064|NCT04809090|Behavioral|SMT|Standard 8 SMT (Stress Management Training) psychological interviews.
15756065|NCT04809090|Device|App CA|An APP together a CA (Conversational Agent).
15756066|NCT04809077|Other|Reverse total shoulder replacement|Long-term radiographic and clinical data of patients who underwent a reverse shoulder replacement
15756067|NCT04809064|Procedure|Arthroscopic Bankart repair procedure|Bankart repair with remplissage consists of arthroscopic anterior inferior capsulolabral repair with arthroscopic infraspinatus tenodesis to the posterior humeral head.
15756068|NCT04809064|Procedure|Open Bankart|Open Bankart repair consists of anterior capsulorrhaphy with labral repair.
15756069|NCT04809064|Procedure|Latarjet|Latarjet consists of open transfer of the coracoid to the anterior glenoid bone deficiency.
15756070|NCT04809064|Other|Post-Operative Rehabilitation|Post-operative rehabilitation will be conducted following surgical procedure-specific rehabilitation guidelines and will be progressed based on individual needs.
15756071|NCT04809051|Other|Stratified Transplant Survival Metric|"Both transplant metric conditions display the number of hearts offered to each center, the number of hearts accepted by each center, and the number of transplants performed at each center (in a year), in addition to the condition-specific metrics below. The stratified condition instead features a pair of values corresponding to each center's offers/acceptances/transplant survival rates for donor hearts of optimal or adequate quality."
15756072|NCT04809051|Other|SRTR Information Format|The information format varies based on how the transplant hospital statistics are organized when presented to participants on the choice screen. The SRTR conditions mimic the information format present on the SRTR public reporting website.
15756073|NCT04809038|Other|dry needling|Patient will be placed in a comfortable prone position and encouraged to maintain complete relaxation. The selected active MTrPs was prepared by wiping the area with alcohol pad, and a gauge needle with its plastic guide tube in place will be palced over the active MTrPs .a tapping motion will be used to advance the needle to a depth of 5 to 10 mm for 30 seconds
15756074|NCT04809038|Other|magnesium sulphate iontophoresis|The subjects in the iontophoresis group received MgSO4 iontophoresis using an iontophoretic drug delivery system (Phoresor_IIAuto,ModelPM850,IOMED. MTrPs were examined using pincer palpation and marked by pin. MgSO4 was applied to the active positive electrode using a syringe with a concentration of 100 mg/cm2. The active electrode was placed directly over the marked area where the sensitive MTrPs were located. The dispersive electrode was applied to the skin 6 inches distal from the active electrode.
15756075|NCT04809038|Other|stretching exercise|The patient will be placed in a comfortable and relaxed sitting position with his back supported ; one hand was placed on the side of the head applying the stretching force, while the other hand was placed on the patients shoulder applying shoulder stablization . The direction of stretched force was in flexion , side bending to the opposite side and rotation to the same side . The stretched position will be sustained for 30 seconds , then a relaxation period of 30 seconds . This procedure was repeated 3 times .
15756076|NCT04809025|Device|endoscopy|gastroscope
15756077|NCT04809025|Procedure|Surgery|radical gastrectomy
15756078|NCT04809012|Biological|STI-3031|STI-3031 is an anti-PD-L1 antibody
15756079|NCT04808999|Drug|Pembrolizumab Injection|200 mg IV infusion
15756080|NCT04808986|Diagnostic Test|Serological test for the detection of IgG anti-SARS-CoV-2|Self-sampling dried-blood spot (DBS) kits will be send to each participant including material (a DBS card, lancets, pad), detailed printed instructionson how to perform thetest, and a self-addressed stamped padded envelope to be returned with the card to the centralized biobank (CEPH Biobank, Paris, France). Tubes will be sent sent to the virology laboratory (Unité des virus Émergents, Marseille, France) for serological analysis.
15756081|NCT04808973|Drug|Dolutegravir plus lamivudine in a FDC|All participants will receive an ART regimen composed by Lamivudine plus Dolutegravir in a single pill (FDC)
15756082|NCT04808960|Diagnostic Test|clinical Computed Tomography|Clinical CT was acquired (scanned at 1.25mm x 1.25mm on a standard algorithm and then reformatted into an axial, coronal and sagittal series at 3mm x 2mm) on all fully intact cadavers prior to the onset of this study by the Schulich School of Medicine & Dentistry at the University of Western Ontario, in accordance with the Anatomy Act of Ontario and guidelines of Western's Committee for Cadaveric Use in Research.
15756085|NCT04808934|Drug|Apixaban|Adults receiving apixaban
15756086|NCT04808934|Drug|dabigatran|Adults receiving dabigatran
15756087|NCT04808934|Drug|rivaroxaban|Adults receiving rivaroxaban
15756088|NCT04808934|Drug|VKAs|Adults receiving VKA
15756089|NCT04808921|Diagnostic Test|Xiamen Wiz Biotech Co., Ltd. SARS-CoV-2 Antigen Rapid Test|Rapid Antigen diagnostic device performance comparative to RT-PCR
15756090|NCT04808908|Biological|N-803|N-803, provided by ImmunityBio., Inc. will be administered subcutaneously at a dose 6 mcg/kg on Days 0, 21, and 42 (with a dosing window of up to 14 days post the planned dosing day)
15756334|NCT04806880|Device|Web-application|support for olfactory coaching consisting of the inhalation of fragrant essential oils.
15756091|NCT04808895|Drug|Acetylsalicylic acid|administration of one tablet daily for 15 days. On the first day a loading dose of 300 mg will be administered
15756092|NCT04808895|Drug|Placebo|administration of one tablet daily for 15 days. On the first day 3 tablets will be administered
15756093|NCT04808882|Drug|Tinzaparin, Low dose prophylactic anticoagulation|"Participants randomized to the LD-PA strategie will receive the low weight molecular heparin (LMWH) tinzaparin, considering its contraindications, recommended dose ranges and monitoring if applicable, as follows: LD-PA : 3500 IU/24h.
~If tinzaparin is not punctually available, the use of enoxaparin will be allowed as follows: LD-PA: 4000 IU/24h.
~After day-14, or hospital discharge, or in case of an indication for TA, or of serious adverse event related to anticoagulation, the investigational anticoagulation strategy will be discontinued and anticoagulation treatment will be left at the discretion of attending physicians.
~Recommendations for the management of COVID-19 pneumonia will be followed, including the use of dexamethasone. These recommendations will be subject to modifications based on the new literature data."
15756094|NCT04808882|Drug|Tinzaparin, High dose prophylactic anticoagulation|"Participants randomized to the HD-PA strategie will receive the low weight molecular heparin (LMWH) tinzaparin, considering its contraindications, recommended dose ranges and monitoring if applicable, as follows: HD-PA : 7000 IU/24h.
~If tinzaparin is not punctually available, the use of enoxaparin will be allowed as follows: HD-PA: 4000 IU/12h.
~After day-14, or hospital discharge, or in case of an indication for TA, or of serious adverse event related to anticoagulation, the investigational anticoagulation strategy will be discontinued and anticoagulation treatment will be left at the discretion of attending physicians.
~Recommendations for the management of COVID-19 pneumonia will be followed, including the use of dexamethasone. These recommendations will be subject to modifications based on the new literature data."
15756095|NCT04808882|Drug|Tinzaparin,Therapeutic anticoagulation|"Participants randomized to the TA strategie will receive the low weight molecular heparin (LMWH) tinzaparin, considering its contraindications, recommended dose ranges and monitoring if applicable, as follows: TA : 175 IU/kg/24h.
~If tinzaparin is not punctually available, the use of enoxaparin will be allowed as follows: TA: 100 IU/kg/12h.
~After day-14, or hospital discharge, or in case of an indication for TA, or of serious adverse event related to anticoagulation, the investigational anticoagulation strategy will be discontinued and anticoagulation treatment will be left at the discretion of attending physicians.
~Recommendations for the management of COVID-19 pneumonia will be followed, including the use of dexamethasone. These recommendations will be subject to modifications based on the new literature data."
15756096|NCT04808869|Other|Exercise|Cycling 3 times a week for 15 minutes at 70 rpm using blood flow restriction cuffs at different occlusions.
15756097|NCT04808856|Drug|Adrenocorticotropic Hormone|Adrenocorticotropic Hormone Injection 25u qd iv *3d
15756098|NCT04808856|Drug|Methylprednisolone Injection|Methylprednisolone Injection 40mg qd iv *3d
15756100|NCT04808830|Other|Evaluation of musculoskeletal pain prevalence|Prevalence of musculoskeletal pain will be evaluated over 9 body regions using The Nordic Musculoskeletal Questionnaire.
15756101|NCT04808830|Other|Evaluation of quality of life|Quality of life will be evaluated using The EmPHasis-10 questionnaire and The Minnesota Living with Heart Failure Questionnaire.
15756102|NCT04808830|Other|Evaluation of functional exercise capacity|Functional exercise capacity will be evaluated using 6-min walk test.
15756103|NCT04808830|Other|Evaluation of physical activity level|Physical activity level will be evaluated using International Physical Activity Questionnaire- Short Form
15756104|NCT04808817|Diagnostic Test|calorimetry, impedance measurement at baseline and after 3 months of treatment|biobanking (30ml) for cytokines and complement dosages at baseline and after 3 months of treatment calorimetry and impedance measure will be collected at baseline and after 3 months of ICI treatment
15756105|NCT04808804|Diagnostic Test|Optical Coherence Tomography (OCT)|a noninvasive imaging technology used to obtain high resolution cross-sectional images of the retina
15756106|NCT04808791|Drug|Irinotecan|"Irinotecan is an anti-cancer (antineoplastic or cytotoxic) chemotherapy drug. This medication is classified as a plant alkaloid and topoisomerase I inhibitor."
15756107|NCT04808791|Drug|Oxaliplatin|"Oxaliplatin is an anti-cancer (antineoplastic or cytotoxic) chemotherapy drug. Oxaliplatin is classified as an alkylating agent."
15756108|NCT04808791|Drug|TAS 102 (Trifluridine/Tipiracil)|"Trifluridine/Tipiracil is an anti-cancer (antineoplastic or cytotoxic) chemotherapy drug. This medication is classified as an antimetabolite/pyrimidine analog; antimetabolite/thymidine phosphorylase inhibitor"
15756109|NCT04808778|Drug|Hydroxyurea therapy per standard care|Moderate-dose of 20mg/kg/day
15756110|NCT04808765|Procedure|Immediate Breast reconstruction|immediate mastectomy with breast reconstruction with implants or expanders
15756111|NCT04808752|Drug|Almonertinib|Patients meeting the criteria for inclusion and exclusion were included in the high-dose almonertinib treatment group and received oral almonertinib 165 mg once a day.
15756112|NCT04808739|Biological|Adalimumab|Analysis of survival of adalimumab biosimilar in clinical practice
15756113|NCT04808726|Behavioral|Teach Back Method|Effect of Breastfeeding Training on Breastfeeding Success Using The Teach Back Method: Randomized Controlled Study
15756114|NCT04808713|Behavioral|Treatment|The treatment is a therapist-assisted self-help online cognitive-behaviour therapy focusing on post-traumatic stress, sleep and mood. It includes 12 sessions of evidence-based psychotherapeutic components, such as psychoeducation about PTSD, sleep and depression; prolonged exposure to avoided situations and memories; sleep management strategies (restriction of time in bed, stimulus control, sleep hygiene education); behavioural activation; relaxation and mindfulness exercises; problem-solving strategies; and cognitive restructuring. A small portion of material was unlocked each week, and access to one module was accessible after the completion of a previous one. Supervised graduate psychology students provided brief regular weekly contacts for 12 weeks by video chat or phone, according to the participant's preference. Access to the online material was unlimited in time.
15756115|NCT04808700|Other|Follow-up of Episealer implant|Follow-up and radiographic evaluation in patients who received an Episealer implant
15756116|NCT04808687|Drug|Nab paclitaxel and S-1|Nab-Paclitaxel: 125 mg/m2 d1, 8, during each 3-week cycle. S-1: Body surface area < 1.25 m2, 40 mg bid; Body surface area ≥ 1.25 m2 < 1.50 m2, 50 mg bid; Body surface area ≥1.5 m2, 60 mg bid, d1-14;during each 3-week cycle.
15756366|NCT04806542|Behavioral|Treatment as usual|Individual counselling.
15756117|NCT04808674|Behavioral|Cognitive remediation program|Evaluation of REmediation programs for patients suffering from mild cognitive deficits after Cancer
15756118|NCT04808661|Procedure|Thoracic endovascular aortic repair plus optimal medical therapy|Endovascular treatment (thoracic endovascular aortic repair) plus optimal medical therapy
15756119|NCT04808661|Drug|Optimal medical therapy|Optimal medical therapy (strictly control of their blood pressure and heart rate)
15756120|NCT04808648|Drug|SH-1028|tablet, oral, 200 mg once daily for day 1 and day 12
15756121|NCT04808648|Drug|Itraconazole|capsule, oral, 200 mg twice daily for day 8 to day 14
15756122|NCT04808648|Drug|Rifampicin|capsule, oral, 600 mg once daily for day 8 to day 16
15756123|NCT04808635|Other|no intervention, this is a cross sectional questionnaire based study.|no intervention, this is an observational cross sectional study
15756124|NCT04808622|Drug|Trans-Sodium Crocetinate|TSC given as a one-time IV bolus injection
15756125|NCT04808622|Drug|Placebo|Placebo normal saline given as a one-time 7 mL one-time IV bolus injection
15756126|NCT04808609|Device|Lumme mobile phone application|Lumme mobile phone app provides smoking cessation support and tracks smoking behaviors
15756127|NCT04808609|Behavioral|Standard of Care|Smoking cessation counseling and nicotine replacement therapy
15756128|NCT04808583|Procedure|TLH with uterine artery ligation at its origin at the beginning of the operation|After insertion of the ports and surveying the abdomen as in the conventional method a window will be created in the broad ligament to enter the retroperitoneal space with exposure of the iliac vessel and identification of the internal iliac artery and its anterior branch which give rise to the uterine artery. Blunt dissection continues with identification of the paravesical and the pararectal spaces. The ureter is identified medially and the uterine artery laterally and dissection of the ureter away from the uterine artery will be done, followed by sealing the uterine artery 2 mm from its origin from the anterior branch of internal iliac artery
15756129|NCT04808583|Procedure|conventional TLH with uterine artery ligation after the cornual pedicles|"Coagulation and section of round ligaments will be performed about 2 to 3 cm from the pelvic wall using blunt tip laparoscopic sealer LigaSure COVIDIEN (5mm-37cm) with average of sealing cycle of 2 to 4 seconds and 40 watts , followed by opening the anterior leaflet of the broad ligament to the vesico-uterine peritoneal reflection, coagulation and section of the infundibulo-pelvic ligament (total hysterectomy with bilateral adnexectomy) or of the uteroovarian ligament and the fallopian tubes (total hysterectomy). Then opening the posterior leaflet of the broad ligament to the cervix, opening of the vesico-vaginal space and dissecting the bladder downwards will be done (Poojari et al., 2014).
~Coagulation and section of the uterine pedicles: performed on the ascending segment of the uterine artery, will be carried out in a progressive manner on both sides."
15756130|NCT04808570|Drug|TQ-B3525 tablets|TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle.
15756131|NCT04808557|Other|Biorepair Total Protection|Volunteers will use Biorepair Total Protection for home oral hygiene for the following 30 days from the bonding procedure.
15756132|NCT04808557|Other|Sensodyne Repair & Protect|Volunteers will use Sensodyne Repair & Protect for home oral hygiene for the following 30 days from the bonding procedure.
15756133|NCT04808544|Drug|Dinalbuphine sebacate|Naldebain dissolved in benzyl benzoate and sesame oil (a total volume of 2ml) will be prepared in a 5-ml syringe 30 min before administration. Intramuscular injection into the gluteal muscles will be performed by an anesthesiologist under sonography-guidance.
15756134|NCT04808544|Drug|Placebo solution|Benzyl benzoate and sesame oil served as placebo solution (a total volume of 2ml) will be prepared in a 5-ml syringe 30 min before administration. Intramuscular injection into the gluteal muscles will be performed by an anesthesiologist under sonography-guidance.
15756135|NCT04808531|Drug|NanaBis™|NanaBis™ is a nanoparticle water soluble equimolar solution of d9-THC & CBD. One dose is equivalent to 2 actuations of the pump delivering 280 µL volume containing 2.5 mg d9-THC and 2.5 mg CBD
15756136|NCT04808531|Drug|Oxycodone CR|Oxycodone CR tablet is an opioid agonist supplied in 10 mg, 15 mg, 20 mg, 30 mg,40 mg, 60 mg and 80 mg tablets for oral administration. The tablet strengths describe the amount of oxycodone per tablet as the hydrochloride salt.
15756137|NCT04808531|Drug|Placebo Spray|Placebo comparator used against both NanaBis™ and Oxycodone depending on randomisation of arms.
15756138|NCT04808531|Drug|Placebo Tablet|Placebo comparator used against both NanaBis™ and Oxycodone depending on randomisation of arms.
15756141|NCT04808492|Device|CureWave High Intensity Laser|"The participant will lie prone and the HILT will be administered in 9 symmetrical positions which cover the lumbosacral region. Dose will be 1minute per position. The dose will include:
~Power (44 Watts)
~Mode (continues wave)
~Time on (60000 ms)
~Time off (1 ms)
~Repeats (9)
~Distance of electrode from skin will begin 10 from skin surface. The participant may or may not feel mild warmth. Should the subject report excessive warmth or discomfort the probe distance will be increased in 2 intervals until it is comfortable. The entire process will take approximately 10 minutes.
~The participant will lie prone and the Placebo treatment will consist of positioning the HILT probe over the 9 symmetrical positions for 1 minutes each however the no laser will be admitted."
15756142|NCT04808492|Other|Placebo|"The participant will lie prone and the NON ACTIVE HILT will be administered in 9 symmetrical positions which cover the lumbosacral region. Dose will be 1minute per position. THE LASER WILL NOT BE ACTIVE.
~o Distance of electrode from skin will begin 10 from skin surface. The entire process will take approximately 10 minutes."
15756143|NCT04808479|Behavioral|imFREE mCBT|The imFREE condition is a 32-week tailored, interactive text messaging intervention targeting buprenorphine treatment retention and adherence as well as opioid use and associated health consequences. Following a face-to-face CBT session with a clinician, participants receive CBT skills training via daily text messaging, with content themes around relapse prevention, adherence behaviors, and personalized plans to overcome risk factors for treatment discontinuation.
15756202|NCT04807959|Other|20Lighter anti-obesity program|A customized expert supervised 3-phase program including non-invasive proprietary nutritional, behavioral, and physiological components.
15756331|NCT04806906|Drug|CC-486|Investigational product will be dispensed on Day 1 of each treatment cycle. 300 mg CC-486 QD for 14 days of each 28-day treatment cycle
15756144|NCT04808479|Behavioral|mHealth ED|The mHealth condition will provide participants with a manualized health psychoeducation session of equivalent duration to the face-to-face CBT session delivered to imFREE participants. Content focuses on various dimensions of health and well-being. Subsequent to this session participants will receive an informational pamphlet regarding BUP and the importance of adherence. the mHealth component of the intervention comprises text reminders for scheduled MM appointments.
15756145|NCT04808466|Drug|Paclitaxel|Paclitaxel is used as drug for hyperthermic intraperitoneal chemotherapy. Choice of perfusate: Normal saline. Drug selection and dose: Paclitaxel 75 mg/m2 . Treatment course: 2 times (the first time is after surgery, the second time is 48h after first time).
15756146|NCT04808466|Drug|Lobaplatin|Lobaplatin is used as drug for hyperthermic intraperitoneal chemotherapy. Choice of perfusate: Normal saline. Drug selection and dose: lobaplatin 50 mg/m2 . Treatment course: 2 times (the first time is after surgery, the second time is 48h after first time).
15756147|NCT04808453|Drug|CPI-300|CPI-300 will be administered via intravenous infusion on Day 1 of a 14-Day cycle
15756149|NCT04808414|Drug|QPX9003 for IV Infusion|antibiotic
15756150|NCT04808414|Drug|Placebo for IV infusion|Placebo comparator
15756151|NCT04808401|Drug|Oxygen|Two FIO2 settings during stable general anaesthesia resulting in normoxaemic and hyperoxic arterial oxygen partial pressures.
15756152|NCT04808388|Other|MRI|Using MRI for fat fraction and Biodex for isometric strength
15756153|NCT04808362|Biological|OMO-103|OMO-103 will be administered intravenously as 30 min infusion once weekly
15756154|NCT04808349|Other|no intervention|no intervention
15756155|NCT04808336|Other|PRP injection.|Group 1: thirty patients were injected in the facet joint capsule with a series of three ultrasound-guided PRP injections at four-week intervals,
15756156|NCT04808336|Procedure|fixation surgical procedure|Group 2: thirty patients underwent surgery
15756157|NCT04808323|Drug|Capecitabine|825 mg/m^2 twice daily during radiation therapy. (Fluorouracil (5-FU) may be used at the discretion of the treating medical oncologists.) This chemotherapy will be given during the initial radiation dose (50 Gy over 25 frac) and continue for Cohorts A, B, and C.
15756158|NCT04808323|Device|Initial Dose of Radiation before Dose Escalation|50 Gy over 25 frac.
15756159|NCT04808323|Device|Cohort A: Dose Escalation Radiation|Cohort A will receive 14 Gy boost for a total of 64 Gy over 32 total fractions.
15756160|NCT04808323|Device|Cohort B: Dose Escalation Radiation|Cohort B will receive 18 Gy boost for a total of 68 Gy over 34 total fractions.
15756161|NCT04808323|Device|Cohort C: Dose Escalation Radiation|Cohort C will receive 22 Gy boost for a total of 72 Gy over 36 total fractions.
15756162|NCT04808323|Drug|FOLFOX|After the completion of radiation, subjects will receive up to eight cycles of systemic chemotherapy. (FOLFIRINOX may be used at the discretion of the treating medical oncologists.)
15756163|NCT04808310|Device|Quantitative flow ratio|Quantitative flow ratio (QFR) is a computer method that estimates the hemodynamic relevance of a coronary stenosis based on three-dimensional quantitative coronary angiography (3D QCA)
15756164|NCT04808310|Diagnostic Test|Assessment of angiographic severity of the stenosis|The indication to coronary stent intervention will be based on angiography
15756165|NCT04808284|Device|Transcranial direct-current stimulation|A single tDCS session will be delivered to the supplementary motor area (SMA) by a DC stimulator (NeuroConn, Germany). During stimulation, a pair of saline-soaked sponge electrodes (surface 35 cm²) will be used, with one electrode (anode) placed 1,8 cm forward Cz and the other electrode (cathode) over the right supraorbital region, according to the International 10-20 EEG system. Current intensity will be ramp up for 30 seconds until reaches 2 mA, and after 30 minutes current intensity will be ramp down for 30 seconds.
15756166|NCT04808284|Device|Transcranial direct-current stimulation|A single tDCS session will be applied bilaterally over the dorsolateral prefrontal cortex (DLPFC) by a DC stimulator (NeuroConn, Germany). During stimulation, a pair of saline-soaked sponge electrodes (surface 35 cm²) will be placed over F3 (anode) and F4 (cathode), according to the International 10-20 EEG system. Current intensity will be ramp up for 30 seconds until reaches 2 mA, and after 30 minutes current intensity will be ramp down for 30 seconds.
15756167|NCT04808284|Device|Sham Transcranial direct-current stimulation|A single Sham-tDCS session will be applied bilaterally over the dorsolateral prefrontal cortex (DLPFC) or over the supplementary motor area (SMA) by a DC stimulator (NeuroConn, Germany). A pair of saline-soaked sponge electrodes (surface 35 cm²) will be placed according to the International 10-20 EEG system. For SMA , one electrode (anode) will be placed 1,8 cm forward Cz and the other electrode (cathode) over the right supraorbital region. For DLPFC, electrodes will be placed over F3 (anode) and F4 (cathode). Current intensity will be ramp up for 30 seconds until reaches 2 mA, and after 30 seconds current intensity will be ramp down for 15 seconds.
15756168|NCT04808271|Dietary Supplement|Bifidobacterium breve Bif195|1 capsule daily for 8 weeks
15756169|NCT04808271|Dietary Supplement|Placebo|1 capsule daily for 8 weeks
15756170|NCT04808258|Device|C3+ Holter Monitor|Long-Term ECG monitoring (up to 7 days)
15756171|NCT04808245|Drug|Tecentriq 1200 MG in 20 ML Injection|One vial of Tecentriq® (1200 mg) will be administered as an intravenous (i.v.) infusion over 60 minutes every 3 weeks starting 4 weeks after radiotherapy. If the first infusion is tolerated, all subsequent infusions will be delivered over 30 minutes.
15756172|NCT04808245|Biological|H3K27M peptide vaccine|The H3K27M peptide vaccine is injected subcutaneously (s.c.). For a single vaccination 300 μg of the peptide will be emulsified in a total volume of 1 ml.
15756173|NCT04808245|Other|Imiquimod (5%)|One sachet of Aldara® cream (250 mg) will be applied to an area of 5 x 5 cm around the injection site of the H3K27M peptide vaccine 15 min after vaccination and left on the skin for approximately 8 hours according to the instructions in the SmPC. 24 hours after the vaccination a second sachet of Aldara® will be applied by the patient as instructed above and left on the skin for approximately 8 hours.
15756222|NCT04807764|Combination Product|Standing transspinal stimulation followed by robotic gait training|Fifteen people with spinal cord injury will receive 40 daily sessions of 30 minutes of non-invasive high frequency (e.g. 30 Hz) transcutaneous transspinal stimulation during standing followed by 30 minutes of assisted stepping robotic gait training. Before and after training standardized clinical and neurophysiological tests will be used to assess recovery of sensorimotor function.
15756174|NCT04808232|Behavioral|progressive muscle relaxation exercise|"We used the muscle relaxation audio CD produced by the Turkish Psychologists Association. The CD consists of three parts; the 10-min first part includes definition and purpose of relaxation, and points to take into consideration during relaxation, the 30-min second part includes instructions with river sounds, and the 30-min third part includes only relaxing music without instructions. We used the second part of the audio record in this study. Following the instructions on the CD, the students tensed each muscle group from hands to feet, and then, all muscles in their face and body for approximately 10 s. The women breathed in, tensed a specific muscle group, and then relaxed it while breathing out. The relaxation step took 10-20 s before tensing the next muscle group. Thus, the women relaxed by tensing and relaxing the muscle groups in hands, arms, neck, shoulder, chest, stomach, hips, foot and fingers, and all muscles in the face and body."
15756175|NCT04808206|Device|easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)|Investigational device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical). Device for the creation of anastomoses during laparoscopic bariatric surgery manufactured by Ezisurg Medical.
15756176|NCT04808193|Other|Survey|Participants will fill in the survey
15756177|NCT04808180|Other|Biorepair Shock Treatment|Patients from this group will use Biorepair Toothpaste for the first 7 days of the month for 3 months (mild demineralizations) and for 6 months (moderate demineralizations).
15756178|NCT04808167|Device|autoRIC®|The autoRIC device will be modified by the company from the standard cuff inflation of 200 mmHg to 180 mmHg for the purposes of this study. Three cuff sizes are available from the company: small, medium, and large, correlating to standard adult cuff sizes. The remote ischemic preconditioning cycles will be performed daily by trained research personnel during the preparative regimen through day 0 (see Figure 1), defined as transplantation of stem cells (last preconditioning cycle on day -1). A control group will undergo a similar procedure, however, the cuff will not be inflated.
15756179|NCT04808154|Drug|SNP-630|Subjects will receive one single dose of SNP-630 at Day 1. Blood and urine samples will be obtained to determine the PK of orally administered SNP-630.
15756180|NCT04808141|Device|Digital program|Patients in the digital intervention group will benefit from an 8-week program composed of therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by SWORD Health. These patients will be referred to SWORD Health by the investigator who identified the candidate. SWORD Health will then assign a physical therapist to each patient. The physical therapist will contact the patient for onboarding and will manage the case.
15756181|NCT04808141|Other|Conventional PT|Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face PT sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program will follow the protocol outlined in Annex 3, which can however be adapted by the physical therapist to the specific needs of the participant. Participants in this group will be excluded from the per protocol analysis if they complete less than 14 sessions over 8 weeks. Participants in this group will be considered as dropouts if they: a) choose to abandon the study; b) miss four consecutive scheduled PT sessions.
15756182|NCT04808128|Other|Drink A + SC|Consumption of energy drink that contains 80mg caffeine and 27g carbohydrates per 250ml together with simple carbohydrates.
15756183|NCT04808128|Other|Drink B + SC|Consumption of soft drink, non-caffeine drink that contains 27g carbohydrates per 250ml together with simple carbohydrates.
15756184|NCT04808128|Other|Drink C + SC|Consumption of soda water, non-caffeine and non-carbohydrate drink together with simple carbohydrates.
15756185|NCT04808128|Other|Drink A + CC|Consumption of energy drink that contains 80mg caffeine and 27g carbohydrates per 250ml together with complex carbohydrates.
15756186|NCT04808128|Other|Drink B + CC|Consumption of soft drink, non-caffeine drink that contains 27g carbohydrates per 250ml together with complex carbohydrates.
15756187|NCT04808128|Other|Drink C + CC|Consumption of soda water, non-caffeine and non-carbohydrate drink together with complex carbohydrates.
15756188|NCT04808115|Drug|KDS-1001|"Cycles 1-6 (14 days per cycle)
~1 x 109/KDS-1001 cells/infusion administered on day 1 of each cycle"
15756189|NCT04808102|Device|IER AG|The game is a web-based single-player adventure game with 3 levels created with the RPG Maker MV. Playtime is approximately 3 hours.
15756190|NCT04808102|Device|BubbleShooter|A free-to-play arcade browser puzzle game called BubbleShooter.
15756191|NCT04808089|Other|Health Lung App. of mobile phone+ezOxygen mobile spirometry|"Subjects can get reminder to use inhaler on schedule, input ACT score to evaluate the asthma control, get education materials about asthma and operate spirometer to access lung function outside of hospital.
~The physicians can get the information about control status, lung function, adherence of controller and usage of reliver of patients between each clinical visit, if patients following the instruction of Health Lung."
15756192|NCT04808089|Other|Usual care|The research assistant assess/ teach inhaler technique, offering advice on adherence, delivering patient self-management asthma action plan and education the meaning of asthma control accessed by ACT.
15756193|NCT04808076|Procedure|Shunt surgery|Shunt operation
15756194|NCT04808063|Procedure|Prophylactic mesh implantation|Use of an algorithm for prophylactic mesh implantation in high risk patients after emergency midline laparotomy.
15756195|NCT04808037|Drug|Belantamab mafodotin|Belantamab mafodotin in combination with Lenalidomide and Dexamethasone in patients with newly diagnosed Multiple Myeloma transplant-ineligible
15756196|NCT04808024|Procedure|SelfMyofascial Release|Myofascial auto-release consisted of rolling the roller on a group of knee flexors for 3.5 minutes between the sciatic tumor and the knee joint in both directions, omitting the popliteal fossa. Before and after the intervention, sEMG of the biceps and gluteal muscles will be performed.
15756197|NCT04808011|Device|Intelligent Dialysis Assistant (IDA)|The IDA is intended for home dialysis for subjects who are stage 5 kidney diease patients and who perform Peritoneal Dialysis. The system is used deveral times a day for approximately 20 minutes for each cycle. During the interventional period, subjects will use only the investigational IDA system for their in/out exchanges.
15756198|NCT04807985|Device|JVPHome and ultrasound|Remote clinician assessment of JVP height using the JVPHome, and ultrasound based assessment of JVP height in the same patients.
15803769|NCT04420000|Other|Control|Treatment as usual
15756203|NCT04807946|Procedure|lower third molar extraction|"All surgeries were performed by the same expert surgeon (RP), with the buccal approach using local anesthesia, and included the following maneuvers:
~luxation of the coronal portion of the tooth/root in an ipsilateral or parallel direction with respect to the IAN position and running, in order to minimize nerve compression;
~post-extraction residual bone cavity inspection using a Zeiss 4x300 magnification optical system to better identify intra-operative nerve exposure.
~No material was inserted into the residual cavity, neither by regeneration nor by haemostasis.
~After one week, sensitivity was tested on both sides with the tactile test using a 27-gauge needle tip and, if a difference was found, the patient was followed up once a week for the first month and every two weeks thereafter, until he/she reported to perceive the pin-prick test in the affected side the same way as the healthy side."
15756204|NCT04807933|Behavioral|Heart rate variability Biofeedback [HRV-BFB]|BFB consists of a physiological recording used as a visual physiological feedback that can teach us how to control our physiology, which is naturally unconscious and uncontrollable. The BFB focused on the heart rate variability (HRV-BFB) could regulate the autonomic nervous system (vagal tone and sympathetic-parasympathetic balance) and the emotional state. The HRV BFB has received several clinical and experimental confirmations as a physiological remediation method. It is an innovative and non-pharmacological therapy frequently used to relieve stress.
15756205|NCT04807920|Drug|OnabotulinumtoxinA 100 UNT|Intravesical injection
15756206|NCT04807920|Other|Injectable saline|Intravesical injection
15756207|NCT04807907|Behavioral|Infant Directed Speech (IDS) Video + IDS Wall Calendar|"IDS Video: The IDS video was developed by the research team. It is a simple animation with a voiceover describing the value of IDS and encouraging the viewer to speak to her babies and to tell family members to do so as well. The video has been translated into Dagbani and English (viewers select the language). They may choose to watch it twice.
~Breastfeeding women are told by the surveyor following the video, For instance, you could talk to your baby in full sentences when your baby is breastfeeding.
~Wall Calendar: The calendar contains images from the video of parents practicing IDS, and key facts about IDS in bullet points. The 12-month calendar contains an empty star next to each week that the respondent can fill in if they perform IDS at least once a day in that week. The calendar also provides a link to a Facebook page where the respondents can re-watch the video or show it to others (https://www.facebook.com/ghanababytalk/videos)."
15756208|NCT04807894|Drug|Vaginal Cream with Applicator|Vaginal testosterone 300-μg dose will be compounded with 13.5 mg of testosterone propionate in 0.45 mL of polysorbate National Formulary liquid and sufficient emollient cream base to make 45 g total. A calibrated vaginal applicator will be supplied to measure out doses of 1 g each. All study medications will be compounded by a single pharmacy so as to avoid variation in compounding between pharmacies and allow for control of compounding. Randomization will be conducted by the compounding pharmacy to allow for double-blinding of patients and clinicians.
15756209|NCT04807881|Drug|Keynatinib|All subjects shall be treated with Keynatinib twice a day (once every 12 hours), 20 mg each time, fasting within 2 hours before and 1 hour after taking the drug, and taking warm water when taking the drug. It is recommended to take the drug at the same time every day. In case of missed administration, the subjects should be instructed to take it as soon as possible when they think of it on the same day. If it is within 3 hours later than the scheduled administration, the study drug should be taken as soon as possible; if the interval is > 3 hours, skip this time and take the next dose at the normal scheduled time. Do not take double dose at one time. Every 28 days is a treatment cycle until the specified interview completed, PD, intolerable toxicity, death occurs or withdraw from the study (including withdrawal of informed consent by the subject or termination of the study when the investigator judges that the risk is greater than the benefit), whichever occurs first.
15756210|NCT04807868|Procedure|Standard of care liver biopsy|Patients undergoing a standard of care liver biopsy for any reason who are willing to participate will be consented for collecting additional biopsy tissue for research purposes. 1-2 additional biopsy tissue cores will be collected for research. Liver tissue will be biobanked for future use.
15756211|NCT04807868|Other|Fibroscan|A FibroScan will be performed to evaluate longitudinal changes in liver fat and fibrosis.
15756212|NCT04807868|Other|Biospecimen Collection|Blood and urine will be collected.
15756213|NCT04807855|Device|The cMLP device|There is only one medical device we are testing, so only one intervention.
15756215|NCT04807829|Drug|Nabilone|Nabilone is a synthetic endocannabinoid and CB1 agonist.
15756216|NCT04807829|Drug|Placebo|Inactive placebo comparator
15756217|NCT04807816|Drug|Association of berzosertib with gemcitabine|"Gemcitabine will be administered by intravenous 30-minutes infusion on days 1 and 8 every 3 weeks, at a fixed dose of 1000 mg/m².
~Berzosertib will be administered intravenously on days 2 and 9 every 3 weeks (210 mg/m²).
~A treatment cycle consists of 3 weeks (i.e., 21 days) and will be administered during hospitalization."
15756218|NCT04807816|Drug|Gemcitabine|"Gemcitabine will be administered by intravenous 30-minutes infusion on days 1 and 8 every 3 weeks, at a fixed dose of 1000 mg/m².
~A treatment cycle consists of 3 weeks (i.e., 21 days) and will be administered during hospitalization."
15756219|NCT04807803|Diagnostic Test|Assessment of Minimal hepatic encephalopathy (MHE)|Assessment of MHE at the inclusion and 6 months after treatment if diagnosed with MHE: Serum ammonia analysis, psychometric hepatic encephalopathy score (PHES), animal naming test (ANT) and evaluation of abdominal imaging, liver and splenic transient elastography, gastroscopy
15756220|NCT04807790|Other|Telerehabilitation based structured home program applications|"The structured home program will consist of activities determined by the family members according to the functional level of the child and the activities he / she can not do, and which are determined according to the goals specific to the child. In order to ensure that the structured home program created can be implemented by the family, a 1 hour family training will be provided.
~After the structured home program training, a 45-minute video interview will be held with one of the family members (mother-father-caregiver) once a week, in order to check by the physiotherapist whether the home program is implemented correctly. Video interviews will be the telerehabilitation part of the study."
15756221|NCT04807777|Drug|Ruxolitinib|Ruxolitinib will be administered orally twice daily during the entirety of each 28-day cycle.
15756332|NCT04806893|Drug|lerodalcibep|300 mg subcutaneous injection every month (Q4W)
15756333|NCT04806893|Other|Placebo|matching subcutaneous injection every month (Q4W)
15756223|NCT04807764|Combination Product|Lying transspinal stimulation followed by robotic gait training|Fifteen people with spinal cord injury will receive 40 daily sessions of 30 minutes of non-invasive high frequency (e.g. 30 Hz) transcutaneous transspinal stimulation while lying supine on a therapy table followed by 30 minutes of assisted stepping robotic gait training. Before and after training standardized clinical and neurophysiological tests will be used to assess recovery of sensorimotor function.
15756224|NCT04807764|Other|Standing sham transspinal stimulation followed by robotic gait training|Fifteen people with spinal cord injury will receive 40 daily sessions of 30 minutes of sham transspinal stimulation during standing at an intensity where sensation is absent followed by 30 minutes of robotic gait training. Before and after training standardized clinical and neurophysiological tests will be used to assess recovery of sensorimotor function.
15756225|NCT04807751|Drug|Delgocitinib cream|Cream for topical application
15756226|NCT04807751|Drug|Delgocitinib cream vehicle|The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
15756227|NCT04807738|Device|"Neuroproprioceptive facilitation and inhibition in virtual reality"|"The 110 outpatients will be randomized into groups: First arm, individual neuroproprioceptive facilitation and inhibition physical therapy combining key principles of proprioceptive neuromuscular facilitation (PNF) and motor program activating therapy (MPAT) in a real environment and the second arm, the same therapy in virtual reality environment. All participants will undergo 15 sessions, 60 minutes each, twice a week in a period of two months.
~The therapy in a second, interventional group, uses virtual reality and new software that was developed specifically for inducing and motivating for movement according to principles of proprioceptive neuromuscular facilitation (PNF) and motor program activating therapy (MPAT). The software allows immediate feedback and moreover, movement is corrected by a present therapist. Evaluation of speed and performance quality might be extracted from the software of virtual reality."
15756228|NCT04807738|Other|"Neuroproprioceptive facilitation and inhibition"|The first arm of the study will consist of a physiotherapeutic approach based on neurophysiological principles using proprioceptive neuromuscular facilitation (PNF) and motor program activating therapy (MPAT) approaches. MPAT makes use of particular motor patterns that evolve in postural control development. The repetition of activated programs, a set of stimuli, applied to change the posture with anatomical centration of the joint under various conditions in leading to better support of postural stabilization while seated, while getting up, stepping forward, and standing, in order to teach the patients to use the acquired motor skills automatically in daily life. PNF is a method used for learning effective movement patterns with high biomechanical effectiveness based on repetitive stimulation of cooperating alfa-motoneurons and proprioceptors in muscle, tendons and joint capsules. Therapy will be individualized and led in the standard face-to-face regiment.
15756229|NCT04807725|Genetic|Analysis of genetic polymorphisms|For the investigation of genetic polymorphisms, it will be collected a sample of cells from the jugal mucosa with the aid of a swab. The genetic analysis will be done with the DNA extraction technique followed by PCR-RFLP techniques (polymerase chain reaction followed by restriction fragment length polymorphism).
15756230|NCT04807725|Other|Biochemical analysis|For the biochemical analysis of the inflammatory mediators IL-1beta, TNF-alpha and PGE2 a peri-implant crevicular fluid collection will be performed by inserting paper strips into peri-implant sulcus or pocket, in situations of peri-implantitis from the most affected location, while in situations of peri-implant health from the mesio-buccal location.
15756231|NCT04807712|Other|non interventionnal study|
15756232|NCT04807699|Other|Data collection|Clinical and sociodemographic data collected through interview at admission and results of complementary tests performed during hospitalization.
15756233|NCT04807686|Device|Auditory simulation|Each patient will be delivered each of the 2 auditory stimulation protocols considered in the context of the research: stimulation with a traditional algorithm called AT and stimulation with a notched-type algorithm called AE. The order in which will be carried out, for the same patient, each of these 2 protocols (AT then AE or AE then AT) will be randomized.
15756234|NCT04807673|Biological|Pembrolizumab|"Neoadjuvant period: pembrolizumab 200mg IV D1, Q3W, and preoperative therapy with three cycles.
~Adjuvant period: pembrolizumab 200 mg IV D1, Q3W, up to one year, which should be performed within 3-6 weeks after surgery."
15756235|NCT04807673|Drug|Paclitaxel|Neoadjuvant period: paclitaxel 135mg/m^2 IV on Day 2 Q3W, and a total of three cycles.
15756236|NCT04807673|Drug|Cisplatin|Neoadjuvant period: cisplatin 80 mg/m^2 IV on Day 2 Q3W, and a total of three cycles.
15756237|NCT04807673|Radiation|neoadjuvant chemoradiotherapy|neoadjuvant chemoradiotherapy 41.4Gy(1.8Gy×23 fractions) with five cycles of TP(Paclitaxel 50mg/m^2 on D1 and Cisplatin 25mg/m^2 D1, repeated every week
15756238|NCT04807660|Other|middle ear fluid sample|middle ear fluid sample for each enrrolled children
15756239|NCT04807647|Other|"Orhan OSMAN's track Don't Let Your Baby Cry in the Kolik album will be played on the music player."|white noise will be played while breastfeeding
15756240|NCT04807634|Drug|Intravenous Lipid Emulsion (Intralipid 20%)|Lipid emulsion or fat emulsion refers to an emulsion of lipid for human intravenous use. It is often referred to by the brand name of the most commonly used version, Intralipid, which is an emulsion of soy bean oil, egg phospholipids and glycerin, and is available in 10%, 20% and 30% concentrations. The 30% concentration is not approved for direct intravenous infusion, but should be mixed with amino acids and dextrose as part of a total nutrient admixture.
15756241|NCT04807621|Biological|Platelet transfusion|Platelets (10 ml/kg body weight) is transfused.
15756242|NCT04807621|Biological|Fibrinogen concentrate|Fibrinogen concentrate (300 mg/kg body weight) is administered.
15756243|NCT04807608|Other|Usability Assessment|A survey will be administered to the subject at the end of the 6th week of product usage related to the wearable device and the related software platform's usability. Survey items will include both Likert-scale items that will be analyzed quantitatively and open-ended feedback that will be summarized qualitatively.
15756264|NCT04807426|Other|Task Oriented Exercises|"Task Oriented Exercises: Patient will perform upper limb functional activities such as Reaching for objects, putting up and down an object, hand to mouth activity, combing hair, folding piece of cloth grasp and release activity, opening a jar, putting beads in jar and writing letters or draw something will be done. Complexity will be added by increasing speed of task performance.
~Conservative Management:Passive stretching exercises for paretic upper extremity muscles . Stretchings will be applied for 30 sec with 30 sec rest, 10 repetitions for1 set."
15756244|NCT04807595|Other|None (Observational study)|The data source for this project will be HER2 IHC historical scores, local lab rescoring of historical HER2 fixed tissue slides, independent central retesting or local lab retesting (under special occasions) of HER2 IHC status for enrolled patients who have available tissue, other biomarker testing results based on historical testing and/or testing of archived tissue samples when available, and curated patient-level data. Real-world data sources include electronic health records/electronic medical records (EHR/EMR) and biobank registries. Data from EHR/EMR sources will be curated. Biobank tissue for enrolled patients who have multiple samples available will be selected consecutively when possible and will start with the latest available samples then move backward in time.
15756245|NCT04807582|Other|PET/MRI|18F-fluoropivalate tracer injection followed by PET/MRI scan
15756246|NCT04807569|Other|Peripheral magnetic neuromodulation|"Non-invasive peripheral magnetic neuromodulation using the BTL Emsella magnetic stimulator according to the manufacturer's standard protocol: pelvic floor rehabilitation"
15756247|NCT04807569|Drug|Taking drug Tamsulosin|Tamsulosin at a dose of 0.4 mg x 1 time per day orally for 1 month.
15756248|NCT04807556|Other|Alusti Test|Physical and psychological functional conditions are key factors in the elderly population
15756249|NCT04807543|Drug|17-hydroxyprogesterone caproate|intramuscular injection weekly
15756250|NCT04807543|Drug|Castor Oil|intramuscular injection weekly
15756251|NCT04807530|Device|TMS|The investigators will use the NEXSTIM NAVIGATED BRAIN STIMULATION (NBS) SYSTEM to apply 10 Hz nrTMS to healthy controls (HC) and schizophrenia patients (SZ)
15756252|NCT04807517|Drug|Buspirone|All participants in the study will receive open-label treatment with orally administered buspirone for the full duration of the 16-week trial. Buspirone has high affinity for serotonin 5-HT1A and 5-HT2 receptors and moderate affinity for dopamine D2 receptors. It is approved for the management of generalized anxiety disorder in adults.
15756253|NCT04807504|Drug|Ropivacaine|All patients receive erector spinae plane blocks with ropivacaine.
15756254|NCT04807491|Other|Kabat Technique's|"As with all cranial nerves, some specific techniques can also be applied on the facial nerve to enhance responses and improve recovery; the most important are: The rhythmic start: shows and guides the subject into the movements and the scheme; agonist investigation utilizes sequential concentric and eccentric contractions; The inversion of the antagonist: reinforces responses through the induction phenomenon; Repeated contractions: calls for a response with repeated stretching that briefly enables movement; Isometric contractions: for stabilizing and reinforcing the response.
~Conventional therapy exercises"
15756255|NCT04807491|Other|Neuromuscular Re-Education|"After the baseline assessment, the participant in the control will receive Neuromuscular Re-Education. The duration of session will be 45 minutes.Neuromuscular Re-Education: For initiation (acute phase): Active-assisted exercise,Massage and stretch for affected side.For Facilitation ,Active-assisted exercise.For Movement control:Massage and stretching for facial retraction,Assisted and active exercises on involved side.
~For Relaxation,Thermotherapy,Relaxation exercises,Alternating rhythmic movements.
~Conventional therapy exercises"
15756256|NCT04807478|Drug|Omegaven® (fish oil triglycerides) Injectable Emulsion|Dose, frequency and duration is a decision of the Investigator
15756257|NCT04807465|Device|G-Premio Bond in etch&rinse mode|The phosphoric acid gel was applied to enamel and dentin washed for 5s and was dried gently with air spray. The adhesive system was applied to enamel and dentin surfaces and leave it in place for 10s.
15756258|NCT04807465|Device|G-Premio Bond in selective-etch mode|The phosphoric acid was applied only on enamel for 10-15s then washed and was gently dried with air spray. The adhesive system was applied to enamel and dentin surfaces.
15756259|NCT04807465|Device|G-Premio Bond in self-etch mode|The adhesive system was applied to the enamel and dentin surfaces.
15756260|NCT04807452|Other|Strength and balance training|Passive ROM to possible level of knee (flexion and extension), ankle (dorsiflexion and plantar flexion), forefoot (inversion and eversion) and toe (flexion and extension, adduction and abduction) joints.Resisted flexion and extension of knee, dorsiflexion and planter flexion of ankle, inversion and eversion of foot, flexion/extension, and abduction/adduction of toe with help of thera-band.The exercise prescription for strength training was made at approximately 50% of the estimated 1-RM. Exercise progression was achieved by instructing participants to increase the weight lifted in a specific exercise when they could perform 2 sets of 10-12 repetitions without maximal exertion on 2 consecutive training days. On basis of Borg Rating of Perceived Exertion of 10 to 13.Tandem leg stance for first 2 weeks and then it was progressed to Single leg stance toe and heel stance.For dynamic balance:backward walk Tandem walk and sideways walk.
15756261|NCT04807452|Other|Aerobics training|"After the baseline assessment, the participant in the Group B received Aerobic exercise with routine medical care.
~All patients were followed for 3 days a week for 8 weeks treatment. Control Group received aerobic training. Control group received stretching exercise for 10 minutes and then treadmill walk for 10 minutes and then stationary bicycle for 10 minutes, and steppers for 10 minutes and 5 minute cool down ."
15756263|NCT04807426|Other|Multi Sensory stimulation exercises|Multi Sensory stimulation exercises:Identification tasks will be given to a blindfolded patient. Which includes recognizing shapes, sizes , textures ,Identifying heights , hardness , weight discrimination .Difficulty will be added by increasing the objects to be identified. Joint angle perception training will be started with one joint perception and will advance to multiple joints position perception. Task Oriented Exercises: Patient will perform upper limb functional activities such as Reaching for objects, putting up and down an object, hand to mouth activity, combing hair, folding piece of cloth grasp and release activity, opening a jar, putting beads in jar and writing letters or draw something will be done. Complexity is added by increasing speed of task performance. Conservative Management:Passive stretching exercises for paretic upper extremity muscles .Stretchings will be applied for 30 sec with 30 sec rest, 10 repetitions for1 set.
15756328|NCT04806932|Procedure|The modified approach|The first three attempts via the modified approach will be performed. If the first three attempts failed, the location or operator of the subsequent attempts of artery puncture will be changed.
15756265|NCT04807426|Other|Task-oriented exercises and Multisensory stimulation Exercises|"Multi Sensory stimulation exercises:Identification tasks will be given to a blindfolded patient. Which includes recognizing shapes, sizes , textures ,Identifying heights , hardness , weight discrimination .Difficulty will be added by increasing the objects to be identified. Joint angle perception training will be started with one joint perception and will advance to multiple joints position perception. Task Oriented Exercises: Patient will perform upper limb functional activities such as Reaching for objects, putting up and down an object, hand to mouth activity, combing hair, folding piece of cloth grasp and release activity, opening a jar, putting beads in jar and writing letters or draw something will be done. Complexity will be added by increasing speed of task performance.
~Conservative Management:Passive stretching exercises for paretic upper extremity muscles . Stretchings will be applied for 30 sec with 30 sec rest, 10 repetitions for1 set."
15756266|NCT04807413|Drug|Nitric Oxide|The balloon will be opened to deliver nitric oxide at 40 ppm through the cardiopulmonary bypass machine
15756267|NCT04807413|Other|standard of care treatment|standard of care treatment
15756268|NCT04807400|Drug|Inclisiran|Inclisiran 300 mg 3 monthly (Day 1 and Day 90)
15756269|NCT04807400|Behavioral|Behavioural Support|Regular telephone based behavioural support programme delivered throughout the study period.
15756273|NCT04807374|Device|Control IQ|We aim to conduct a non-randomized prospective interrupted time series pilot study to investigate the effect of HCL insulin delivery on glycemic control in underserved adolescents with poorly controlled T1D.
15756274|NCT04807361|Device|Multifocal soft contact lens wear for myopia control|Subjects will be wearing MFCLs for myopia control, and their accommodative responses to various demands (0, 2.5, 3, and 4 D) will be measured using a power refractor.
15756275|NCT04807348|Drug|Chiglitazar 32mg|Administrated once daily
15756276|NCT04807348|Drug|Chiglitazar 48mg|Administrated once daily
15756277|NCT04807348|Drug|Placebo|Placebo of Chiglitazar
15756278|NCT04807348|Drug|Metformin Hydrochloride|most tolerable dose
15756279|NCT04807335|Drug|CT001|nasal spray
15756280|NCT04807335|Drug|Ketamine|iv single dose
15756281|NCT04807335|Drug|sufentanil|iv single dose
15756282|NCT04807322|Procedure|Reverse Total Shoulder Arthroplasty (RTSA)|Implantation of a Reverse Total Shoulder Arthroplasty
15756283|NCT04807309|Drug|Danazol Pill|Danazol 200 mg orally twice a day
15756284|NCT04807309|Drug|Placebo|Placebo twice a day
15756285|NCT04807296|Procedure|TFLEP|"Thulium fiber laser (TFL) is a novel laser technology that delivers a pulsed laser at a more optimal wavelength and a shallower depth of tissue penetration leading to better hemostatic properties. Patients will undergo thulium fiber laser enucleation of the prostate (TFLEP) at the Centre Hospitalier de l'Université de Montréal (CHUM) as a treatment for benign prostate hyperplasia. The surgeon performing TFLEP is experienced in TFLEP procedures.
~Fifty (50) patients will undergo TFLEP."
15756286|NCT04807296|Procedure|m-HoLEP|"The holmium: yttrium-aluminum-garnet (Ho: YAG) laser is the longest running and most studied laser used to perform this minimally invasive procedure. Holmium laser enucleation of the prostate reduces hospital stay and hemoglobin drop while improving IPSS and quality of life, as well as other positive postoperative outcomes compared to the historical gold standard, transurethral resection of the prostate (TURP). HoLEP has been found to have a better enucleation efficiency rate and may have better hemostatic properties when combined with the modulated pulsed laser energy featured associated with Moses technology (m-HoLEP). Patients will undergo m-HoLEP at the Centre intégré universitaire de santé et de services sociaux (CIUSSS) du Nord-de-l'Île-de-Montréal as a treatment for benign prostate hyperplasia. The surgeon performing m-HoLEP is experienced in m-HoLEP procedures.
~Fifty (50) patients will undergo m-HoLEP"
15756287|NCT04807283|Device|Left Atrial Appendage Closure|Closure or occlusion of the left atrial appendage to reduce the risk of thromboembolism in patients with NVAF
15756288|NCT04807270|Other|Intra-articular T-LAB / PRP KIT injection|Intra-articular 3 ml T-LAB / PRP KIT injection in 3 sessions will be applied. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.
15756289|NCT04807270|Other|Intra-articular T-LAB / PRP INJECTION SYRINGE injection|Intra-articular 3 ml T-LAB / PRP INJECTION SYRINGE injection in 3 sessions will be applied. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.
15756290|NCT04807270|Other|Intra-articular SALINE injection|Intra-articular 3 ml SALINE injection in 3 sessions will be applied. As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions.
15756291|NCT04807244|Procedure|Selective Caries Removal with Biodentine™|"Rubber dam placement
~Cleaning of the tooth and rubber dam with ethanol 98%
~Caries removal: Removal of protruding parts of enamel/dentin with high-speed round bur with continuous water cooling, caries removal with a low-speed round bur; peripheral caries is removed until only hard dentin is left, while the pulp wall is excavated until reaching leathery dentin
~Disinfection of the leathery dentin 5 ml 1% NaOCl (speed: 1 ml per min)
~Indirect pulp capping (layer of 1-2 mm) of the carious lesion with Biodentine™ (15 min setting time after mixing)"
15756292|NCT04807244|Procedure|Partial Pulpotomy with Biodentine™|"Rubber dam placement
~Cleaning of the tooth and rubber dam with ethanol 98%
~Caries removal: Removal of protruding parts of enamel/dentin with high-speed round bur with continuous water cooling, caries removal with a low-speed round bur; before accessing the pulp chamber, the central caries will be left, peripheral caries will be excavated completely
~Disinfection of the leathery dentin 5 ml NaOCl 1% (speed: 1 ml per min)
~Accessing the pulp chamber with a high-speed round bur and removal of 2-3 mm pulp tissue; irrigation with 2 ml NaOCl 1%
~Hemostasis will be achieved with a sterile foam pellet soaked with NaOCl 1% with gentle pressure to the pulp for 3 min
~If hemostasis could not be achieved within 3 min, step 6 will be repeated once. In case of no hemostasis, transfer of the case to Intervention: full pulpotomy with Biodentine
~Confirmed hemostasis: pulp capping with Biodentine™ (layer min. 2-3 mm, 15 min setting time after mixing)"
15805991|NCT04401293|Drug|Enoxaparin|Full Dose LMWH anticoagulation therapy
15756293|NCT04807244|Procedure|Full Pulpotomy with Biodentine™|"Rubber dam placement
~Cleaning of the tooth and rubber dam with ethanol 98%
~Caries removal: Removal of protruding parts of enamel/dentin with high-speed round bur with continuous water cooling, caries removal with a low-speed round bur; before accessing the pulp chamber, the central caries will be left, peripheral caries will be excavated completely
~Disinfection of the leathery dentin 5 ml NaOCl 1% (speed: 1 ml per min)
~Accessing the pulp chamber with a high-speed round bur and removal of the entire pulp chamber roof; full pulpotomy to stump level with a high-speed round bur under continuous irrigation with 5 ml NaOCl 1%
~Hemostasis will be achieved with a sterile foam pellet soaked with NaOCl 1% with gentle pressure to the pulp for 3 min
~If hemostasis could not be achieved within 3 min, step 6 will be repeated once. In case of no hemostasis, exclusion.
~Confirmed hemostasis: pulp capping with Biodentine™ (layer min. 2-3 mm, 15 min setting time after mixing)"
15756294|NCT04807244|Procedure|Direct composite filling after selective caries removal/full pulpotomy/partial pulpotomy|"Dentin cleaning with a low-speed round bur
~Use of Scotchbond Universal™ and Filtek Supreme XTE™ according to manufacturer's recommendation"
15756295|NCT04807231|Biological|Blood withdrawal|Blood withdrawal in order to perform a bioavailable testosterone RIA (Radio-Immuno Assay).
15756296|NCT04807218|Behavioral|Virta Health|The comprehensive remotely-delivered continuous remote care to induce nutritional ketosis combined with remote medication management is the Virta treatment, and while on this treatment, subjects will have access to Virta health coaches and licensed medical providers who will perform medical therapy management, health coaching, nutrition and behavior change education, biometric feedback, and the option to participate in a community for peer support.
15756297|NCT04807205|Device|RF Non-Invasive Treatment|Self-controlled single-arm group using the Elite IQ device
15756298|NCT04807192|Radiation|stereotactic body radiotherapy|one administration of SBRT 8 Gy at D1
15756299|NCT04807192|Drug|CMP-001|4 sequential administrations of CMP001 at Day 1 (SC), Day 5 (±1) (IT), Day 9 (±1) (IT) and Day 16 (±1) (IT)
15756300|NCT04807179|Device|Experimental: RF Device Arm|Non-invasive radiofrequency Alexandrite laser
15756301|NCT04807166|Drug|Drug: Anlotinib|Anlotinib will be administered orally,once a day (12 mg) on days 1-14 of a 21-day cycle
15756302|NCT04807166|Drug|Drug: Carboplatin/Paclitaxel|Paclitaxel 175 mg/m2 was given intravenously for 3 hours, D1 Carboplatin AUC 5 was given intravenously for 1 hour, D1
15756303|NCT04807140|Drug|Toripalimab, nab-paclitaxel, carboplatin|"Patients receive Toripalimab IV on day 1, nab-paclitaxel IV on day 1 and carboplatin IV on day 1.
~Treatment repeats every 21 days for up to 2-4 courses in the absence of disease progression or unacceptable toxicity."
15756304|NCT04807140|Drug|Toripalimab|"Patients receive Toripalimab IV on day 1.
~Treatment repeats every 21 days for up to 2-4 courses in the absence of disease progression or unacceptable toxicity."
15756305|NCT04807140|Procedure|Surgical resection|Surgical therapy will be at the discretion of the treating surgeon per standard of care.
15756306|NCT04807127|Drug|Immune checkpoint blockade|ICI, administered as standard-of-care treatment
15756307|NCT04807127|Drug|Targeted therapy|TKI, administered as standard-of-care treatment
15756308|NCT04807127|Radiation|Radiotherapy|RT, administered as standard-of-care treatment
15756309|NCT04807114|Drug|Immune checkpoint inhibitor|Standard-of-care treatment for st.IV NSCLC (no driver mutation, PD-L1 > 50%)
15756310|NCT04807114|Drug|Chemotherapy + Immune checkpoint inhibitor|Standard-of-care treatment for st.IV NSCLC (no driver mutation, PD-L1 < 50%)
15756311|NCT04807101|Drug|midazolam alone|elimination of fentanyl from conscious sedation
15756312|NCT04807088|Procedure|Tactile-kinesthetic Stimulation|
15756313|NCT04807088|Other|Placebo|
15756314|NCT04807062|Procedure|surgery|tunnel bone tamps method (TBTM) was used to reduce the depressed articular fragments and then structural bicortical autologous ICBG was used to fill the valley tunnel.
15756315|NCT04807049|Other|Observational|Observational
15756316|NCT04807036|Device|Hypotension Prediction Index|HemoSphere Clinical Platform with Acumen Hypotension Prediction Index Feature
15756317|NCT04807023|Biological|blood sampling|blood sampling
15756318|NCT04807010|Procedure|Prostate Artery Embolization|Prostate artery embolization reduces symptoms from benign prostatic hyperplasia by delivering embolic materials to the prostate through the prostatic arteries.
15756319|NCT04807010|Procedure|Sham Prostate Artery Embolization|Angiogram without embolization initially. At 6 months patients will be allowed to crossover to prostate artery embolization.
15756320|NCT04806997|Diagnostic Test|Vascular occlusion test|The VOT procedure was conducted twice in each patient, before and 15 min after intrathecal injection. An NIRS sensor (INVOSTM 5100C Cerebral/Somatic Oximeter; Medtronic, Minneapolis, MN, USA) was attached to the patient's gastrocnemius muscle. A tourniquet (A.T.S ® 3000 Automatic Tourniquet System; Zimmer Inc., Warsaw, IL, USA) was applied to the thigh and inflated to a pressure value 50 mmHg over the patient's baseline systolic blood pressure in the leg and maintained for 5 min. After a 5-min ischemic period, the tourniquet was rapidly deflated to 0 mmHg. The StO2 data was continuously recorded during the VOT procedure. After confirmation of spinal anesthesia using cold sensitivity, the VOT procedure was repeated in the same manner as mentioned above. The occlusion slope and recovery slope were calculated based on the measured StO2 data.
15756321|NCT04806984|Other|Participant outreach|Participants in the experimental arms will receive a call center phone call or MyChart message to remind them to schedule their appointments.
15756322|NCT04806958|Other|PulsePoint notification|"The PulsePoint interface software monitors each 9-1-1 call on dispatch computers and is automatically triggered by particular conditions including call type (e.g. suspected cardiac arrest) and location type (public location). When triggered, the system pushes location data to all PulsePoint mobile application users within 400 meters of the emergency location.
~When a mobile device running the PulsePoint Respond application receives the alert data from the PulsePoint system, the device alarms with auditory, tactile (vibration) and visual stimuli. The application presents a map showing the exact location of the suspected cardiac arrest and the closest public access defibrillator."
15756323|NCT04806945|Drug|HLX10|IV infusion.
15756324|NCT04806945|Drug|Paclitaxel|IV infusion
15756325|NCT04806945|Drug|Cisplatin|IV infusion
15756326|NCT04806945|Drug|Carboplatin|IV infusion
15756327|NCT04806945|Drug|Placebo to HLX10|IV infusion
15756329|NCT04806932|Procedure|The conventional approach|The conventional approach
15756335|NCT04806867|Other|SePaRIC-Covid19 cohort|All patients with Chronic Inflammatory Rheumatism who were contacted by telephone as part of the innovative organizational strategy and who did not object to the use of their data.
15756336|NCT04806854|Drug|LUM-201|Administered orally once daily
15756337|NCT04806841|Behavioral|Motivational intervention|Three group meeting of 60 minutes to help create effective goals and methods on maintaining motivation to exercise regularly. These meetings will help participants create effective goals and methods on maintaining their motivation to exercise regularly. They will then receive a monthly phone call follow-up at months 4-6.
15756338|NCT04806841|Other|Control intervention|Participants in the control group will be simply encouraged to exercise at the EPIC center and complete the online surveys. Participants in the control group will receive the skills/tactics at the end of the study.
15756339|NCT04806828|Other|Preoperative classification|Score of inguinal hernia
15756340|NCT04806815|Other|A survey of 60 questions was created through the internet-based 'Google Forms surveys' site.|"The following tests will be used together with the survey;
~Menstrual Symptom Questionnaire
~Fatigue Severity Scale
~Short Form Of Coronavirus Anxiety Scale"
15756341|NCT04806802|Device|APIOC Sphere and APIOC Astigmatism|Single Vision Contact Lenses
15756342|NCT04806776|Other|24hrs dressings change|The first dressing change and sampling were completed 24 hours after catheterization in the operating room or PICU.When bedside nurse remove the dressing ,the researchers used 4 normal saline cotton swabs to wipe the skin under the dressing. Taking the puncture point as the center, 4 cotton swabs wipes 4 points in the northwest, northeast, Southeast and northeast direction 1cm away from the puncture point,separately.Then the specimen delivered to Laboratory..Then the second dressing change and sampling were completed 7days later(if there is no clinical indication occur,such leaking,blood).
15756343|NCT04806776|Other|7days dressings change|The first dressing change and sampling were completed 7 days after catheterization in the operating room or PICU.When bedside nurse remove the dressing ,the researchers used 4 normal saline cotton swabs to wipe the skin under the dressing. Taking the puncture point as the center, 4 cotton swabs wipes 4 points in the northwest, northeast, Southeast and northeast direction 1cm away from the puncture point,separately.Then the specimen delivered to Laboratory..(if there is no clinical indication occur,such leaking,blood).
15756344|NCT04806763|Device|Menicon Z Night|To assess the use of Menicon Z Night contact lenses for reducing myopia progression in children
15756345|NCT04806763|Device|Control|Distance, single-vision glasses were used as control
15756346|NCT04806737|Drug|Teriflunomide Oral Tablet|The study will be conducted with two treatment groups in the form of a 2:1 parallel group comparison and will serve to compare oral treatment with 14 mg/d teriflunomide vs. placebo in subjects with well-controlled coeliac disease undergoing gluten challenge. The screening period will be up to 8 weeks, followed by a 7-day run-in treatment period with a loading dose of teriflunomide followed by a 6 day therapeutic maintenance dose, an initial 4-week treatment-free follow-up period and a 6 month closing follow-up.
15756347|NCT04806724|Behavioral|Opening the Conversation|The intervention includes 5 weekly sessions (1.5 hours each), plus participant educational materials, and is delivered to couples via videoconference by a trained interventionist. Participants are asked to complete home activities between sessions. Sessions focus on development of communication and coping skills, with a focus on reproductive and sexual health distress.
15756348|NCT04806724|Behavioral|Side by Side|The intervention includes 4 weekly sessions (1.5 hours each), plus participant educational materials, and is delivered to couples via videoconference by a trained interventionist. Participants are asked to complete home activities between sessions. Sessions focus on development of communication and coping skills, with a focus on general cancer-related distress.
15756349|NCT04806711|Device|Menicon Z Night|Menicon Z Night orthokeratology contact lenses were used to assess their efficacy in reducing myopia progression in children
15756350|NCT04806711|Device|Control|Distance, single-vision glasses were used as a control
15756351|NCT04806698|Device|Menicon Z Night|Children wearing Menicon Z Night orthokeratology contact lenses
15756352|NCT04806698|Device|Control|Children wearing distance single-vision glasses or distance single-vision soft contact lenses
15756353|NCT04806685|Behavioral|Sleep education|Medical nutrition therapy plus behavior-based sleep education intervention
15756354|NCT04806685|Behavioral|Diet only|No sleep education
15756355|NCT04806659|Drug|SH1573 Capsules|Patients from each cohort will be administered SH1573 capsules every day of 28-day treatment cycles until disease progression or unacceptable toxicities.
15756356|NCT04806646|Drug|Sonidegib|TS1: assumption 14 days on and 14 days off. TS2: assumption 7 days on and 21 days off.
15756357|NCT04806633|Drug|Dapagliflozin 5mg|Patients randomized in this arm will receive dapagliflozin at a dose of 5mg once daily.
15756358|NCT04806633|Drug|Placebo|Patients randomized in this arm will receive placebo.
15756359|NCT04806607|Procedure|19G FNB|Biopsy specimen adequacy using the 19G FNB
15756360|NCT04806607|Procedure|22G FNB|Biopsy specimen adequacy using the 22G FNB.
15756361|NCT04806594|Device|Papix acne scar|PapiX acne scar, class IIa medical device, gel for acne scar. to be applied 2 times per day during the 8 weeks of study duration
15756362|NCT04806581|Drug|Allogeneic Hepatocyte|Allogeneic hepatocyte with cell numbers L,M,H respectively.
15756363|NCT04806568|Other|Cognitive Training|The cognitive training treatment is a Greek adaptation of BrainHQ developed by Posit Science Corporation. The intervention will target speed, attention, working memory, and executive function through the visual and auditory domains via a set of 15 exercises. Each daily training session consists of four exercises chosen from an active set of six. Participants will be instructed to train for one hour per day, three days per week, over 12 weeks via a tablet or a laptop. Each subject will receive at least 20 sessions of computerized cognitive training.
15756364|NCT04806555|Diagnostic Test|Compression ultrasound examination|After successful revascularisation for acute ischemia and clinical suspicion of acute compartment syndrome, compression ultrasound (CU) will be performed in OR followed by standard intra-compartmental measurement. Two physicians will perform two subsequent measurements of the affected limb after revascularisation. The unaffected limb will be examined once to obtain baseline elasticity ratio values. All CU examinations will be documented in PACS (picture archiving and communication system) and evaluated after ICP measurement, and if necessary, fasciotomy is performed.
15756365|NCT04806542|Behavioral|TMR-group|A mindfulness-based 8 week program.
15756367|NCT04806529|Drug|Adjuvanted SARS-CoV-2 Subunit vaccine (aCoV2)|Biological/Vaccine: Investigational adjuvanted SARS-CoV-2 Subunit vaccine
15756368|NCT04806529|Drug|Comparator|Biological/Vaccine: A dose of 0.5 mL saline for injection will be administrated to subjects randomized to receive the placebo
15756369|NCT04806516|Device|Summit RC+S System with ECoG Paddles|"Summit RC+S System with ECoG Paddles consists of:
~Olympus RC+S implantable pulse generator (IPG), Model B35300R: 2 per subject x 5 subjects = 10 units
~Extension Leads, Model 37087: 2 per subject X 5 subjects = 10 units
~DBS Leads, Model 3387: 2 per subject X 5 subjects = 10 units
~Patient Therapy Manager (PTM), Model 4NR009: 1 per subject x 5 subjects = 5 units
~Recharge Therapy Manager (RTM), Model 97755: 1 per subject x 5 subjects = 5 units
~Clinician Telemetry Module (CTM), Model 4NR011: 1 per subject x 5 subjects = 5 units
~Research Lab Programmer (RLP), Model 4NR010: 1 unit
~Research Software Development Kit (RDK), Model 4NR013: 2 units
~Subdural Quadripolar Paddle Lead, Model 09130: 2 per subject x 5 subjects = 10 units"
15756370|NCT04806516|Other|One Month Blinded Discontinuation Period:|"The subject and Independent Evaluators are blinded to timing of discontinuation. In all cases, the sequence will be as follows in one-week segments: 100% Active, 50% Active, Sham and Sham. Subjects will be seen weekly. Amplitude will be reduced by 50% at start of week 2 and turned off at start of week 3. Subjects will be told that DBS will be discontinued at some point during the 4 weeks. The purpose of the 50% initial reduction is to minimize rebound effects. The programmer (not the PI in this case) will be open to the design and perform sham activation as described previously. Relapse is defined as a 25% increase of the Y-BOCS over two consecutive visits compared to discontinuation baseline."
15756371|NCT04806503|Drug|UNR844|Ophthalmic solution for topical ocular administration
15756372|NCT04806503|Drug|Placebo|Placebo
15756373|NCT04806490|Diagnostic Test|the diagnosis for Yin Deficiency Syndrome|The measurement of the standard scale for syndrome differentiation of Yin Deficiency Syndrome
15756374|NCT04806477|Other|Telemedicine Consultation|Brief telemedicine consultation, blinded to subsequent face-to-face evaluation.
15756375|NCT04806477|Other|Face-to-face Consultation|Direct face-to-face evaluation (without telemedicine consultation before).
15756376|NCT04806464|Drug|Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell))|Intratumoral injection only. The dosing date can be the Day 1 only or Days 1 through 5.
15756377|NCT04806451|Drug|Crinecerfont|CRF1-receptor antagonist
15756378|NCT04806451|Drug|Placebo|Non-active dosage form
15756379|NCT04806451|Drug|Crinecerfont|CRF1-receptor antagonist
15756380|NCT04806438|Other|Group A|Patient will receive 5 ml of 10% lignocaine by air driven jet nebulizer for 20 min
15756381|NCT04806438|Other|Group B|Patients will receive bilateral superior laryngeal nerve block and transtracheal instillation of 4 ml of 2% lignocaine, along with viscous xylocaine gargles twice
15756382|NCT04806425|Drug|Intralipid|intralipid is given as a preconditioning drug during off bump coronary artery bypass grafting surgery to measure efficacy in decreasing post operative ischemia
15756383|NCT04806425|Drug|Placebo|normal saline is given in same volume to normal saline group over the same duration
15756384|NCT04806412|Diagnostic Test|meassurement of PD-L1, ALK, EGFR|"PD-L1 test will be performed on cell-blocks using PD-L1 antibodies 22C3 and staining platform Dako Omnis (Agilent, Glostrup -Denmark).
~ALK test will be performed on cell-blocks using staining platform Dako Omnis (Agilent, Glostrup- Denmark) and ALK antibodies Origene clone: OT1A4. Sample quality is assessed as for PD-L1.
~EGFR mutation analysis will be performed as follows: after tumor content evaluation of hematoxylin and eosin stained slides, relevant regions are macrodissected and subjected to a standard genomic DNA extraction procedure using the GeneRead DNA FFPE Kit (Qiagen). Samples will be analysed using the GeneRead QIAact Actionable Insights Tumor Panel (Qiagen)"
15756385|NCT04806399|Other|Educational Materials and Decision Counseling|Participants in the active comparator arm will receive an introductory letter and lung cancer screening educational materials. A site care coordinator will contact each participant post receiving materials.
15756386|NCT04806386|Dietary Supplement|Psyllium|Psyllium fiber powder baked into a bar is commonly used as a first line of treatment for patients with fecal incontinence.
15756387|NCT04806373|Drug|Cathflo Activase|Cathflo Activase 4mg in 50ml normal saline given through chest pleural catheter
15756388|NCT04806373|Drug|Talc Slurry Pleurodesis|Talc, 5 gm in 50 ml Normal Saline given through chest pleural catheter
15756389|NCT04806360|Procedure|ACRF surgery|A new surgical procedure that previously proposed by our team.
15756390|NCT04806360|Procedure|conventional anterior surgery|Anterior cervical discectomy and fusion surgery or anterior cervical corpectomy and fusion surgery.
15756391|NCT04806360|Procedure|conventional posterior surgery|Laminectomy and fusion surgery or laminoplasty surgery.
15756394|NCT04806334|Diagnostic Test|MRI imaging of the pelvis/bladder|The pelvic MRI will be multiparametric (mp)-4D MRI incorporating high resolution diffusion weighted imaging (HR-DWI).
15756395|NCT04806334|Diagnostic Test|genomic analysis of tumor|Single cell RNA sequencing of transurethral resection of bladder tumor (TURBT)
15756396|NCT04806321|Other|Project SOLVE|This 30-minute, self-guided, digital program is designed to help adolescents solve, rather than be overwhelmed by, everyday problems.
15756397|NCT04806321|Other|Project SUCCESS|This 30-minute, self-guided, digital program is designed to help adolescents develop study skills.
15756398|NCT04806308|Behavioral|Otolaryngology stretching micro-breaks (OSMB)|Standardized microbreak stretch that is designed to perform intraoperatively within the sterile field at medically convenient 20-40 min intervals throughout each procedure.
15756399|NCT04806295|Other|any/all treatments for blood cancer|Following people undergoing any/all treatments for blood cancer.
15756400|NCT04806269|Device|Fitbit and Glandy|Data collection from wearable devices (Fitbit Inspire 2 TM) and a mobile app (Glandy TM) Fitbit collects user's heart rate, activity, and sleep data. Glandy collects user's subjective symptom scores.
15756401|NCT04806256|Behavioral|Clinical Decision Support System|This project is based on the artificial intelligence (AI) algorithm to screen the effective methods of traditional Chinese medicine intervention for dry eye and its applicable conditions, and optimize the traditional Chinese medicine intervention plan for dry eye through the evaluation of evidence-based medicine and expert consensus, and construct the traditional Chinese medicine intervention Clinical Decision Support Systems (CDSS) for dry eye. At the same time, the CDSS is provided to clinicians for their selection.
15756402|NCT04806256|Other|Routine intervention|The routine intervention without CDSS is also the clinically common intervention at present.
15756403|NCT04806243|Drug|Regorafenib Pill&Camrelizumab|Regorafenib，80 mg，QD，Q3w Camrelizumab，200 mg，IV，Q3w
15756404|NCT04806230|Drug|sertraline, mirtazapine, venlafaxine, citalopram, escitalopram|Naturalistic treatment
15756405|NCT04806217|Other|Theory of Mind|Patients will be submitted to different neuropsychological tests used in routine and the non-verbal false belief task through in the Theory of Mind
15756406|NCT04806204|Other|music therapy|Music therapy will be applied to one group before angiography and to the other group during angiography. Patients who will listen to music before angiography will be offered Turkish Folk, Classical, Turkish Art and Sufi Music as an option, and the music preferred by the patients will be played with headphones for 15-20 minutes. Patients who will listen to music during angiography will be offered Turkish Folk, Classical, Turkish Art and Sufi Music as an option, and the music preferred by the patients will be played through a speaker that will be placed in the angiography hall during the angiography procedure.
15756407|NCT04806191|Other|Evidence based treatment strategy|Evidence-based clinical examination and treatment plan
15756408|NCT04806191|Other|Targeted patient information package|GPs will in cooperation with the patients tailor a information package targeted to the patients needs regarding their clinical shoulder diagnosis and individual implications and needs (Pain, sleep, exercises etc.).
15756409|NCT04806191|Other|Treatment as usual (TAU)|Usual care as provided by the GP
15756410|NCT04806178|Biological|Bacillus Calmette Guerin|0.1 ml of lyophilized, live, and attenuated BCG intradermal vaccine, containing between 2 and 8 x 1.000.000 C.F.U in a single dose.
15756411|NCT04806178|Other|PLACEBO|0.1 ml 0.9% saline in the same volume as the BCG vaccine in a single dose.
15756412|NCT04806165|Behavioral|Repeated Administration|A discussion with the chatbot, including follow ups over the course of 2 weeks to encourage help seeking for their eating disorder.
15756413|NCT04806165|Behavioral|Personalized Recommendation|A discussion with the chatbot, including identifying a personalized recommendation for accessing help for their eating disorder.
15756414|NCT04806165|Behavioral|Motivational Interviewing|A discussion with the chatbot, including motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder.
15756415|NCT04806165|Behavioral|Core Modules Only|A discussion with the chatbot, including only the core modules.
15756416|NCT04806165|Behavioral|Motivational Interviewing, Personalized Recommendation, Repeated Administration|A discussion with the chatbot, including motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder, identifying a personalized recommendation for accessing help for their eating disorder, and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder.
15756417|NCT04806165|Behavioral|Motivational Interviewing, Repeated Administration|A discussion with the chatbot, including motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder.
15756418|NCT04806165|Behavioral|Motivational Interviewing, Personalized Recommendation|A discussion with the chatbot, including motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder and identifying a personalized recommendation for accessing help for their eating disorder.
15756419|NCT04806165|Behavioral|Personalized Recommendation, Repeated Administration|A discussion with the chatbot, including identifying a personalized recommendation for accessing help for their eating disorder and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder.
15756420|NCT04806165|Behavioral|Psychoeducation|A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders.
15756421|NCT04806165|Behavioral|Psychoeducation, Repeated Administration|A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder.
15756422|NCT04806165|Behavioral|Psychoeducation, Personalized Recommendation|A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders and identifying a personalized recommendation for accessing help for their eating disorder.
15756423|NCT04806165|Behavioral|Psychoeducation, Motivational Interviewing|A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders and motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder.
15756424|NCT04806165|Behavioral|Psychoeducation, Motivational Interviewing, Personalized Recommendation|A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders, motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder, and identifying a personalized recommendation for accessing help for their eating disorder.
15756425|NCT04806165|Behavioral|Psychoeducation, Personalized Recommendation, Repeated Administration|A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders, identifying a personalized recommendation for accessing help for their eating disorder, and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder.
15756426|NCT04806165|Behavioral|Psychoeducation, Motivational Interviewing, Repeated Administration|A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders, motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder, and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder.
15756448|NCT04805944|Drug|Dolutegravir|Patients starting dolutegravir will be included and sampled both before (blood for pharmacogenetic and metabolite profiling, stools for microbiota profiling) and after (blood for pharmacokinetic and metabolite profiling, stools for microbiota profiling) the start of dolutegravir
15756427|NCT04806165|Behavioral|Psychoeducation, Motivational Interviewing, Personalized Recommendation, Repeated Administration|A discussion with the chatbot, including psychoeducational content to increase knowledge related to eating disorders, motivational interviewing techniques to help overcome barriers to seeking care for their eating disorder, identifying a personalized recommendation for accessing help for their eating disorder, and follow ups over the course of 2 weeks to encourage help seeking for their eating disorder.
15756428|NCT04806152|Other|High intensity exercise|Supervised high-intensity combined-modality exercise was administered to participants in the exercise arm for 3 times per week for 6 months. A post-exercise recovery protein drink (31g whey-based) was given within 15 minutes after each supervised exercise session.
15756429|NCT04806152|Other|Usual care home exercise|Walking 30 minutes, chair rises and flexibility exercises for trunk and upper extremities 5 days per week
15756430|NCT04806139|Behavioral|Remote Enhance Fitness|The Remote Enhance Fitness Intervention will include live-streamed exercise classes (1-hour long, 3 days per week, 16 weeks). Certified Enhanced Fitness trainers will lead the exercise classes per Enhance Fitness guidelines, including modifications and gradual progression. During weeks 8-12 participants will have the option to wear a Fitbit during classes for up to 6 class session (2 weeks) for collection of heart rate, steps, and physical activity intensity along with ratings of perceived exertion (RPE) during exercise classes.
15756431|NCT04806113|Biological|Moderna COVID-19 vaccine|Two doses from the Moderna vaccine will be administered intramuscularly. The time between dose 1 and dose 2 of the vaccine will be 28 days.
15756435|NCT04806061|Drug|Sodium bicarbonate|sodium bicarbonate 8.4% to achieve urinary pH >7.5
15756436|NCT04806061|Drug|standard care|standard care
15756437|NCT04806035|Biological|TG-1801|It is a bispecific, first-in-class, CD47 and CD19 antibody
15756438|NCT04806035|Biological|Ublituximab|recombinant chimeric anti-CD20 monoclonal antibody, available in 25 mg/mL administered as an IV infusion once every 4 weeks
15756439|NCT04806022|Other|Fatigability assessment|Each participant will do both types of fatigue over 2 appointments spaced by 7 days so that the subject can recover from induced fatigue. The sequence of fatigue tasks will be randomized.
15756440|NCT04806009|Behavioral|'Mindful Living With Insomnia (MLWI)' Intervention via WeChat mini-program|The MLWI Intervention involves 12 sessions over 6 weeks course, 2 sessions a week and 0.5 hours per session. Two new sessions of online lessons will be updated weekly in the 6 weeks. Each session is consisted of theoretical lecture, mindfulness practices, sharing common difficulties and coping way during mindfulness practices and homework assignment in the form of video or audio. The Mindfulness practices embedded in the intervention include mindful breathing, mindful body scan, mindful dealing with thoughts and emotions, mindful meditation, mindful movement, and daily life mindfulness. In the intervention, the participants will also receive sleep hygiene education.Participants in the Intervention Group will receive the MLWI Intervention after follow the WeChat mini-program.
15756441|NCT04806009|Behavioral|'Cognitive Behavioral Therapy for insomnia (CBT-I)'via WeChat mini-program|The CBT-I involves 12 sessions over 6 weeks course, 2 sessions a week and 0.5 hours per session. Two new sessions of online lessons will be updated weekly in the 6 weeks. Each session is consisted of theoretical lecture, cognitive or behavioral regulation techniques, sharing common difficulties and coping way during mindfulness practices and homework assignment in the form of video or audio.Participants in the Control Group will receive CBT-I after follow the WeChat mini-program.
15756442|NCT04805996|Behavioral|Diabetes remission using total diet replacement and eHealth contact with the healthcare provider|Participants will replace usual foods with the commercially available total diet replacement Modifast (Impolin AB), which is delivered to them during the study period without any cost. Participants will be supplied with a scale, a finger-stick blood glucose meter and a blood pressure monitor and will be advised to measure body weight, fasting blood glucose and blood pressure every morning. The results are registered in the mobile phone application Telia Health Monitoring (Telia Sweden AB) and are wirelessly transmitted to the study team.
15756443|NCT04805983|Drug|BMS-984923|Day 1: Admission, administration of study drug, and 2 night in-patient stay; Day 3: Discharge following the completion of all scheduled procedures.
15756444|NCT04805957|Dietary Supplement|Sulforaphane|Sulforaphane comes from eating certain cruciferous vegetables. In this case the pills are made from broccoli seeds.
15756445|NCT04805944|Drug|Dolutegravir|Dolutegravir treated patients will be included and samples (blood for pharmacokinetic, pharmacogenetic et metabolite profiling, stools for microbiota profiling) drawn at follow-up.
15756446|NCT04805944|Drug|Bictegravir|Bictegravir treated patients will be included and samples (blood for pharmacokinetic, pharmacogenetic and metabolite profiling, stools for microbiota profiling) drawn at follow-up.
15756447|NCT04805944|Drug|Dolutegravir|Patient having discontinued dolutegravir will be included and samples (blood for pharmacogenetic and metabolite profiling, stools for microbiota profiling) drawn at follow-up.
15756545|NCT04805099|Drug|Checkpoint inhibitor|Treatment with checkpoint inhibitors in patients with preexisting autoimmune disease
15756546|NCT04805086|Biological|MON002|Autologous monocytes
15756449|NCT04805944|Drug|Bictegravir|Patients starting bictegravir will be included and sampled both before (blood for pharmacogenetic and metabolite profiling, stools for microbiota profiling) and after (blood for pharmacokinetic and metabolite profiling, stools for microbiota profiling) the start of bictegravir
15756450|NCT04805931|Behavioral|Behavioral economics|Tailored behavioral economic text messaging vs. standard text messaging
15756451|NCT04805918|Behavioral|VIPP-SD|Parenting program
15756452|NCT04805905|Other|FACE-Q patient reported outcome|"As both interventions of treatment are gold standards and clinical equipoise exists if one intervention is superior to the other, there is no true control group. However, for the purpose of the application, the local flap group will be chosen as the control group.
~Skin graft (Experimental): Participants in the experimental group will receive a skin graft and receive the FACE-Q skin cancer questionnaire pre- and post-treatment. There will also be photos taken of the patient's face along with the distributed questionnaires.
~Local flap (Control): Participants in the experimental group will receive a local flap and receive the FACE-Q questionnaire pre- and post-treatment."
15756453|NCT04805892|Diagnostic Test|BIOZEK COVID-19 Antigen Rapid Test|The BIOZEK COVID-19 Antigen Rapid Test is used for the detection of SARS-CoV-2 antigens in nasopharyngeal swab specimens from individuals who are suspected of having COVID-19.
15756454|NCT04805879|Biological|FMT oral Capsules|Each dose of FMT capsules consists of 20 capsules. The 20 over encapsulated capsules are derived from 100 grams of stool donated by a healthy indvidual that was screened to have no mental health issues or chronic or contagious doseases. Each capsule will contain 0.67 ml of pelleted intestinal microbes. Therefore it is considered that the 20 capsules are equivalent to 100 grams of stool
15756455|NCT04805879|Biological|Placebo Capsules|Placebo Capsules that will look and weigh the same as the FMT oral capsules.
15756456|NCT04805840|Device|CoV-SCAN rapid COVID-19 antigen test|SARS-CoV-2 rapid antigen screening test
15756457|NCT04805827|Drug|Gabapentin|1 tablet contains 600 mg Gabapentin
15756458|NCT04805827|Drug|Neurontin|2 capsule contains 2*300 = 600 mg Gabapentin
15756459|NCT04805814|Diagnostic Test|CMR results disclosed|The results of the CMR are disclosed, and used to guide management
15756460|NCT04805814|Diagnostic Test|CMR performed but results not disclosed|The results of the CMR are not disclosed, and management is angiography-guided
15756461|NCT04805801|Drug|Emicizumab subcutaneous injection|Safety and efficacy and PK, FVIII inhibitor titers will be evaluated by follow-up observation.
15756462|NCT04805788|Radiation|Proton Stereotactic Body Radiation Therapy|Undergo SBPT
15756463|NCT04805788|Other|Quality-of-Life Assessment|Ancillary studies
15756464|NCT04805775|Drug|Desflurane Inhalant Product|Objective To observe the effect of desflurane on postoperative sleep quality of patients undergoing elective radical mastectomy. Methods 124 patients undergoing elective radical mastectomy were randomly divided into two groups: Propofol group and desflurane group
15756465|NCT04805762|Other|Your COACH Next Door|Children in the study are attending the lifestyle intervention Your COACH Next Door. A coach is supporting the child and it's family to reach their goals regarding lifestyle.
15756466|NCT04805749|Other|Manual Therapy: osteopathy|"Osteopathic protocol applied at week 0, 1, 2 and 3:
~Spinal mobilisation of L1, L2 and L3 vertebrae to stimulate the arterial supply of mesenteric attachments of the colon and small intestine.
~Visceral osteopathic therapy to address adhesions/ fixations in the presacral fascia, Toldt fascia, posterior peritoneum and caudal peritoneum.
~Circulatory techniques to stimulate the celiac plexus, the superior and inferior ganglia.
~Cranial osteopathy techniques to address the vagus parasympathetic nerves."
15756467|NCT04805736|Procedure|Microwave Ablation|Image-guided microwave ablation 7-10 days prior to surgery
15756468|NCT04805736|Drug|Camrelizumab|Camrelizumab 200 mg was given a few days after microwave ablation
15756469|NCT04805736|Procedure|Breast Surgery|Standard of care breast conserving surgery or radical mastectmoy
15756470|NCT04805723|Procedure|VATS|"Video-assisted thoracoscopic surgery is a minimal invasive technique in which used to diagnose or treat for lung diseases. During this surgery, one or two small incisions are opened via camera and surgical instruments in patient's chest wall. Thus, less muscle and nerve tissue are damaged.
~Thoracotomy is an open surgical technique in which allowing visualization of the inside of the thorax. During this surgery, an incision in patient's chest wall is made between the ribs and some muscles important for respiration are cutted to remove a part of lung."
15756471|NCT04805723|Procedure|Thoracotomy|Thoracotomy is an open surgical technique in which allowing visualization of the inside of the thorax. During this surgery, an incision in patient's chest wall is made between the ribs and some muscles important for respiration are cutted to remove a part of lung.
15756472|NCT04805710|Drug|clopidogrel combined with rivaroxaban arm|Patients who have been selected will be randomized to the clopidogrel combined with rivaroxaban arm. clopidogrel 75 mg once daily and rivaroxaban 10 mg once daily
15756473|NCT04805697|Dietary Supplement|placebo group|subjects drank 50 ml , 1 bottle a day for 8 week
15756474|NCT04805697|Dietary Supplement|fermented grape drinks|subjects drank 50 ml , 1 bottle a day for 8 week
15756475|NCT04805684|Device|LUS Twelve area|Application of 12 areas (2 posterior, 2 lateral, and 2 anterior)lung ultrasonography protocol using the convex ultrasound probe (2-6 MHz)
15756476|NCT04805684|Device|LUS Fourteen area|Application of 14 areas (3 posterior, 2 lateral, and 2 anterior) lung ultrasonography protocol using the convex ultrasound probe (2-6 MHz)
15756479|NCT04805658|Diagnostic Test|Clinical examinations|Clinical examinations
15756480|NCT04805645|Other|No intervention (Retrospective Cohort Observational)|No intervention as this study is a Retrospective Cohort Observational
15756481|NCT04805619|Device|Biomime Morph, a tapered drug eluting stent (DES) with hybrid design|Biomime Morph DES is a cobalt-chromium stent, with strut thickness of 65 µm, a hybrid cell design (closed cells in the extremity and open cells in the middle) and a conic shape, where the proximal part of the stent is 0.5 mm larger than the distal part (Table 1). In addition, the Biomime Morph elutes Sirolimus from a biodegradable polymer matrix.
15756482|NCT04805606|Drug|CKD-843 A|Single Dose
15756483|NCT04805606|Drug|CKD-843 B|Single Dose
15756484|NCT04805606|Drug|CKD-843-R|QD, PO
15756547|NCT04805073|Drug|Promethazine|1cc 25mg/ml Promethazine (study medication)
15756485|NCT04805593|Device|WaveLight EX500 excimer laser system|FDA approved stationary scanning-spot excimer laser system used during refractive surgery for the treatment of myopia, myopic astigmatism, hyperopia, hyperopic astigmatism, and mixed astigmatism. For this clinical study, the Wavefront Optimized (WFO) Ablation profile of the WaveLight EX500 excimer laser system will be used for bilateral LASIK treatment of hyperopia with and without astigmatism.
15756486|NCT04805593|Procedure|LASIK|Procedure that reshapes the front part of the eye (cornea) so that light traveling through it is properly focused on the back part of the eye (retina). The procedure will be performed using the WaveLight EX500 excimer laser system.
15756487|NCT04805580|Procedure|unilateral intrathecal block|Quadratus lunborum block
15756488|NCT04805567|Device|endocuff|The Endocuff is a device that can be mounted on the tip of an endoscope and may assist to inspect a greater surface of the colonic mucosa by pulling backwards, flattening, and stretching the colonic folds as the endoscope is gradually withdrawn.
15756489|NCT04805554|Other|Joint Insights decision aid|The Joint Insights decision aid was developed by Dell Medical School faculty in collaboration with OM1, a health outcomes and predictive analytics company. This decision aid uses patient-report outcome measures (PROMs) - specifically, the PROMIS Global and the KOOS JR - along with patient clinical and demographic information (age, sex, race, ethnicity, chronic narcotic use, body mass index), in machine-learning-based predictive analytic models to provide personalized estimates of likely benefit or harm from total knee replacement surgery. The tool is designed to collect PROMs or pull in PROMs collected through other systems (e.g., an EHR or a third-party PROM platform). It also provides condition-specific education to patients with knee OA and allows a patient to reflect on and document their preferences and goals. The personalized risk/benefit report generated by the decision aid is meant to be discussed with the patient's provider to enhance shared decision making.
15756490|NCT04805541|Procedure|Color fundus photography|Subjects will undergo fundus photography before and after administration of mydriatic agent.
15756491|NCT04805541|Drug|Mydriatic Agent|Subjects will be administered mydriatic medication to dilate their pupils.
15756492|NCT04805541|Device|Diabetic retinopathy screening|"Screening for existence of More than mild or Vision-threatening Diabetic Retinopathy, and/or Diabetic Macular Edema."
15756493|NCT04805528|Radiation|Acupuncture-Like Transcutaneous Electrical Stimulation (ALTENS)|Twice weekly ALTENS therapy for 12 weeks
15756494|NCT04805515|Behavioral|Nicotine Corrective Messages|Messages communicating misperceptions of nicotine's role in health harms as well as misperceptions about reduced nicotine content cigarettes and e-cigarettes.
15756495|NCT04805502|Behavioral|Exercise Modes|Moderate intensity aerobic exercise, moderate intensity resistance exercise, moderate intensity combination exercise
15756496|NCT04805489|Other|Mask|"The sequence of mask wearing will be done by drawing lots, in double blind. Only the nurse will be informed of the mask sequence. The doctor will take measurements without seeing the type of mask placed between the athlete's face and the VO2 mask.
~The patient will not know which mask will be applied. He will have been informed that he will test three masks (a so-called high-tech mask which will in fact be without a mask, a surgical mask and a general public mask). When the mask is put on, the athlete's eyes will be closed, the sequence without a mask, presented to the subject as a high-tech mask, will be done with a mask that will be put on like a surgical mask or a mask for the general public, except that it will be hollowed out in its center.
~The effort tests will be done on a carpet with a filter called COVID on the VO2 masks."
15756497|NCT04805476|Device|Non invasive mechanical ventilation|Prophylactic non invasive mechanical ventilation
15756498|NCT04805476|Device|GP|GP subjects will receive oxygen therapy through a nasal cannula with 4 to 6 L / min of oxygen according to team routine and patient need.
15756499|NCT04805463|Other|Control group|The group that did not undergo any procedure after gingivectomy and gingivoplasty operation. Periodontal pack (Coe-Pak, GC America Inc, IL, USA) was applied to the wound area.
15756500|NCT04805463|Other|PRF group|The group in which PRF is applied to the wound area after gingivectomy and gingivoplasty operation. Periodontal pack (Coe-Pak, GC America Inc, IL, USA)was applied over the PRF.
15756501|NCT04805463|Other|CGF group|The group in which CGF is applied to the wound area after gingivectomy and gingivoplasty operation. Periodontal pack (Coe-Pak, GC America Inc, IL, USA) was applied over the CGF.
15756502|NCT04805463|Other|AFG group|The group in which AFG is applied to the wound area after gingivectomy and gingivoplasty operation. Periodontal pack (Coe-Pak, GC America Inc, IL, USA) was applied over the AFG.
15756503|NCT04805450|Procedure|ES before fully covered SEMS placement|
15756504|NCT04805450|Procedure|no ES before fully covered SEMS placement|
15756505|NCT04805437|Device|3D TLSO|Brace treatment with Boston 3D 20 hours a day until skeletal maturity.
15756506|NCT04805437|Device|Standard TLSO|Brace treatment with standard Boston brace 20 hours a day until skeletal maturity.
15756507|NCT04805424|Procedure|Lipo-abdominoplasty|Abdominoplasty plus liposuction
15756508|NCT04805424|Procedure|Abdominoplasty|Abdominoplasty
15756509|NCT04805411|Biological|CM310|IL-4Rα monoclonal antibody
15756510|NCT04805411|Biological|Placebo|Placebo
15756511|NCT04805398|Biological|CM310|300 mg every two weeks
15756512|NCT04805398|Biological|Placebo|300 mg every two weeks
15756513|NCT04805385|Dietary Supplement|PS128|Each PS128 capsule contained >1 × 10^10 colony forming units (CFU) with microcrystalline cellulose and weights 425 ± 25 mg The placebo capsules only contained 425 ± 25 mg microcrystalline cellulose
15756514|NCT04805372|Other|VD+VF group|where they should review a video of an expert performing central vein operation and a video of their own most recent operation, before returning to do another operation. This will be repeated for a total of 5 central vein cannulation encounters and 5 video reviews.
15756515|NCT04805372|Other|VD group|where they should review a video of an expert performing central vein operation before returning to do another operation. This will be repeated for a total of 5 central vein cannulation encounters and 5 video reviews.
15756516|NCT04805359|Behavioral|Normoxic exercise|Trained on a bicycle ergometer at 60% of maximal work-rate (60%Wmax)for 30 minutes per day, 5 days per week for 6 weeks
15756517|NCT04805359|Behavioral|Hypoxic exercise|Trained on a bicycle ergometer at 60% of maximal work-rate (60%Wmax)for 30 minutes per day, 5 days per week for 6 weeks
15756548|NCT04805073|Drug|Placebo|1cc 0.9% Sodium Chloride (placebo)
15756679|NCT04804033|Drug|BHV-3500 (zavegepant)|BHV-3500 (zavegepant) softgel capsule.
15756518|NCT04805346|Device|autoRIC®|With the patient sitting upright in bed or a chair, the remote ischemic conditioning intervention will consist of 4 automatic cycles of upper arm blood pressure cuff inflation to 200 mm Hg for 5 minutes to induce transient, noninjurious, limb ischemia, followed by cuff deflation for 5 minutes, for a total of 35 minutes (autoRIC®, Cellaegis Devices, Mississauga, ON, Canada).17 The remote ischemic preconditioning cycles will be performed by trained research personnel prior to each cycle of chemotherapy (total treatments variable based on chemotherapy protocol
15756519|NCT04805333|Drug|Artemisia annua 450mg|Artemisia annua will be self-administered via a preparation of decaffeinated coffee.
15756520|NCT04805333|Drug|Artemisia annua 900mg|Artemisia annua will be self-administered via a preparation of decaffeinated coffee.
15756521|NCT04805333|Drug|Artemisia annua 1350mg|Artemisia annua will be self-administered via a preparation of decaffeinated coffee.
15756522|NCT04805333|Drug|Artemisia annua 1800mg|Artemisia annua will be self-administered via a preparation of decaffeinated coffee.
15756523|NCT04805333|Drug|Artemisia annua - recommended phase II dose|Artemisia annua will be self-administered via a preparation of decaffeinated coffee. The dose for this cohort will be based on analysis of previous cohorts.
15756524|NCT04805320|Procedure|Dental Extraction|Extraction
15756525|NCT04805307|Drug|CMG901|CMG901 will be administered intravenously (IV) on Day 1 of every 21-day cycle. Individual subjects may continue study treatment until there is evidence of disease progression (clinical or radiologic) judged by Investigators, unacceptable toxicity or other reasons for treatment discontinuation.
15756526|NCT04805281|Other|monolithic zirconia (5Y-TZP/3-YTZ) ZirCAD Prime.|wear of the new material of monolithic zirconia (5Y-TZP/3-YTZ) ZirCAD Prime in posterior teeth
15756527|NCT04805281|Other|Lithium Dislicate IPS e.max crown|wear of lithium disilicate IPS e.max crown in posterior teeth
15756528|NCT04805268|Diagnostic Test|18F FDG PET/CT|18F FDG PET/CT imaging (fluorine-18-fluorodeoxyglucose positron emission tomography/computed tomography).
15756529|NCT04805255|Radiation|Hypofractionated Stereotactic Radiotherapy|A course of hypofractionated stereotactic radiotherapy (HF-SRT) is delivered within 2 weeks with a cumulative dose of 3000 - 3500 cGy in 5 fractions.
15756530|NCT04805242|Other|Dextrose Prolotherapy Injection|"Subacromial injection: 5 cc solution (15% dextrose + saline + 1% lidocaine solution) will be injected into the subacromial bursa using a sterile 21 gauge injector.
~Extra-articular injection: Previously marked using a sterile 27 gauge injector (dental needle); A total of 10 cc solution (15% dextrose + saline + 1% lidocaine solution) will be injected into the infraspinatus, teres minor, supraspinatus insertion on the tuberculum majus, the subscapularis insertion on the tuberculum minus, the coracoid process and the long head of the biceps.
~As a home exercise program, shoulder range of motion and stretching, shoulder isometric and isotonic strengthening exercises will be given at least three days a week with 3 sets of 10 repetitions."
15756531|NCT04805242|Other|Saline Injection|"Subacromial injection: 5 cc solution (saline + 1% lidocaine solution) will be injected into the subacromial bursa using a sterile 21 gauge injector.
~Extra-articular injection: 5 cc solution (saline + 1% lidocaine solution) will be injected to the attachment areas of the previously marked tendons to the bone using a sterile 30 gauge injector.
~As a home exercise program, shoulder range of motion and stretching, shoulder isometric and isotonic strengthening exercises will be given at least three days a week with 3 sets of 10 repetitions."
15756532|NCT04805229|Other|Retrospective analysis of opioid use after surgery|Retrospective analysis of opioid use after one of the following surgical procedure categories: laparoscopic cholecystectomy, laparoscopic appendectomy, minor hernia repair (including laparoscopic or open inguinal, femoral, umbilical, and epigastric hernia repair), open and laparoscopic ventral/incisional hernia repair, laparoscopic colectomy, open colectomy, vaginal hysterectomy, laparoscopic hysterectomy, and open abdominal hysterectomy.
15756533|NCT04805216|Procedure|Blood test|"Participants will have blood tests at baseline (15 - 30 days after 2nd dose of Covid-19 vaccine, +/- 5 days):
~T, B & NK cells
~Full Blood Count and differential
~Serum Immunoglobulins
~Antibodies against VZV, CMV, Rubella
~Quantiferon assay (T-Cell response)
~Covid antibody assay (LIAISON® SARS-CoV-2 S1/S2 IgG quantitative assay)
~Participants will have blood tests during follow up (after second dose of Covid-19 vaccine) with a window of +/- 5 days:
~Day 30 (Covid antibody assay) - this test will not be applicable if baseline test performed at day 25-35
~Day 60 (Covid antibody assay)
~Day 90 (Covid antibody assay)
~Day 120 (Covid antibody assay and quantiferon assay)"
15756534|NCT04805203|Other|blood sample analyses|maximum 4 blood samples analyses per patient. At diagnosis of covid 19, in intensif care (if applicable), at covid19 recovery and 6 months after recovery
15756537|NCT04805177|Procedure|hematoma evacuation|early minimally invasive image guided hematoma evacuation in patients suffering from ICH
15756538|NCT04805164|Procedure|Corticotomy and use of the bone substitute : Cerament-G device.|Corticotomy and Cerament-G device
15756539|NCT04805164|Procedure|Corticotomy|Corticotomy
15756540|NCT04805151|Other|No intervention|No intervention
15756541|NCT04805138|Other|Spectrophotometer|To objectively measure the discoloration of the peri-implant mucosa, spectrophotometric measurements of the buccal mucosa will be performed at study implant and at control tooth.
15756542|NCT04805125|Biological|Moderna COVID-19 Vaccine, mRNA-1273 (100 μg)|intramuscular injection, proposed as a series of two doses (0.5 mL each), dosing is 100 microgram on day 0 and day 28
15756543|NCT04805125|Biological|Pfizer-BioNTech COVID-19 Vaccine BNT162b2 (30 µg)( Comirnaty®)|intramuscular injection, proposed dosing is 30 microgram of the diluted vaccine solution (0.3 mL each) on day 0 and day 21
15756544|NCT04805112|Behavioral|Provision of multiple self-tests|Participants will be given multiple Oraquick Advance HIV-1/2 test kits to distribute to their sexual partners for partner testing or couple testing. Phone interviews will be conducted with the participants to assess whether they provided a HIV self-test to their partner, if the test was used, how it was used (partner testing or couple testing), if the partner disclosed his results, the partner's reaction to the results, and if the partner went for confirmatory testing
15756549|NCT04805060|Drug|TQB2858 injection|TQB2858 administered intravenously (IV) on Day 1 of each 21-day. The established dose of TQB2858 is diluted with normal saline [0.9% (w/v) sodium chloride solution], and the infusion time is 60 ± 10 min.
15756550|NCT04805047|Behavioral|education and monitoring|regular education programs supported by a dietician in combination with urine sodium monitoring as a feedback
15756551|NCT04805034|Other|Age, BMI,Baseline HBV DNA, Baseline HBeAg level, Baseline HBsAg level, Antiviral treatment, Serum ALT level|Exposure factors: Age, BMI, Family history, Baseline HBV DNA, Baseline HBeAg level, Baseline HBsAg level, Antiviral treatment, Serum ALT level
15756552|NCT04805021|Other|no intervention|no intervention
15756553|NCT04805008|Other|Lactation cookies|1 serving of 2 OZ of cookies per day for 30 consecutive days. These cookies will contain ingredients thought to increase breast milk production.
15756554|NCT04805008|Other|Control cookies|"1 serving of 2 OZ of cookies per day for 30 consecutive days.
~The cookies will not contain ingredients thought to increase breast milk production."
15756555|NCT04804995|Other|There is no intervention.|No intervention.
15756556|NCT04804982|Other|Questionnaire|The participants will have to fill in a questionnaire about their knowledge and their attitude regarding auditory risk.
15756557|NCT04804969|Device|MyoVista wavECG Test|The MyoVista wavECG is a standard 12-Lead high-performance, multi-channel resting interpretive electrocardiograph providing both a Glasgow Interpretive Analysis and unique MyoVista wavECG Information.
15756558|NCT04804956|Procedure|Stool sample|One stool sample will be taken at baseline for microbiota characterization
15756559|NCT04804956|Procedure|Rectal mucosa sample|Characterization of tissue microbiota before and after surgery.
15756560|NCT04804956|Procedure|Mesorectal adipose tissue sample|Characterization of tissue microbiota and dysfunction
15756561|NCT04804956|Procedure|Subcutaneous adipose tissue sample|Characterization of tissue microbiota and dysfunction
15756562|NCT04804956|Procedure|Visceral adipose tissue sample|Characterization of tissue microbiota and dysfunction
15756563|NCT04804956|Behavioral|Dietary assessment|Dietary assessment will be taken at baseline
15756564|NCT04804943|Device|NOA-001|NOA-001 will be replaced regularly (at 22 to 24 hours after the initiation of procedure), and will be continuously performed until 168 hours from the enrollment.
15756565|NCT04804930|Procedure|picture|We will perform a non-invasive assessment of the scalp with a dermoscope by taking two standardized pictures on the frontal area and the occipital area in order to a blinded analysis of trichoscopic patterns
15756566|NCT04804904|Drug|TQ-B3101|TQ-B3101 oral capsule
15756567|NCT04804891|Biological|Cell Therapy|Infusion of containing 1x106/kg CD34+ cells from donor bone marrow selected using the CliniMACS® CD34 Reagent System.
15756568|NCT04804878|Procedure|Collection of blood, tissue, and other biological samples.|Behavioral health assessments, including quality of life.
15756569|NCT04804878|Other|Medical Chart Review|Health data abstracted directly from patient's health records
15756570|NCT04804865|Other|prognostic assessment|determination of a prognostic score with 3 clinical and 5 biological parameters.
15756571|NCT04804852|Other|sarcopenia assessment|evaluation of sarcopenia by CT san at the C3 vertebrae
15756572|NCT04804839|Other|First research arm|Patients in this group were given 8-week PFMT (including knack maneuver) and lifestyle recommendations for the treatment of urinary incontinence symptoms.
15756573|NCT04804839|Other|Second research arm|Patients in this group were given only 8-week PFMT (including knack maneuver) for the treatment of urinary incontinence symptoms.
15756574|NCT04804839|Other|Third research arm|It is the control group and patients in this group were given alone8-week PFMT (without knack maneuver).
15756575|NCT04804826|Procedure|Pelvic Reconstructive Surgery|Pelvic Reconstructive Surgery including total vaginal hysterectomy
15756576|NCT04804813|Drug|Cabozantinib|Cabozantinib tablets
15756577|NCT04804800|Other|Experimental group 1 : Virtual Reality|Patients benefit from the care recommended by the HAS, the virtual reality program and time for relaxation and body scan.
15756578|NCT04804800|Other|Experimental group 2 : Virtual Reality + Multi Sensorial Remediation|Patients benefit from the care recommended by the HAS, the virtual reality program, the multisensory remediation, and also the body scan.
15756580|NCT04804774|Behavioral|WW program modified for people with Type 2 diabetes|This 6-month intervention includes the use of WW's mobile app, weekly virtual workshops, and private online community. The program involves: self-monitoring of weight, dietary intake, and physical activity; dietary changes; increasing physical activity; shift in mindset; and behavioral strategies to manage goals. Participants will set goals and weigh-in with a coach via virtual workshop weekly and be encouraged to use the app and private online community daily. The virtual workshop features a behavior change technique and enables the participant to practice it to support their goals. Participants are given a personalized food plan based on expert healthy eating guidelines, an activity plan to promote regular physical activity and techniques to help shift mindset for lasting change. The coach will help with goal setting, overcoming setbacks, and follow-up on progress toward goals weekly. Participants will be encouraged to participate in a private Facebook group for motivational support.
15756581|NCT04804761|Other|Electroacupuncture|Needle insertion on bilateral LI4 HeGu and PC6 NeiGuan and ipsilateral ST6 JiaChe and ST7 XiaGuan (as shown in Table 1), using disposable sterile acupuncture needles (length 25 mm, diameter 0.25 mm; Seirin Corporation, Shizuoka, Japan)
15756582|NCT04804735|Device|REV : local anesthesia and virtual reality|REV : local anesthesia and virtual reality in Implanted Venous Access Device (IVAD) procedure under local anesthesia
15756583|NCT04804735|Device|MUS : local anesthesia and music therapy|MUS : local anesthesia and music therapy in Implanted Venous Access Device (IVAD) procedure under local anesthesia
15756584|NCT04804722|Device|18F-FDG PET-CT (fluorodesoxyglucose positron emission tomography)|18F-FDG PET-CT exams during 30 minutes with injection of radiopharmaceutical product
15756585|NCT04804709|Drug|Panobinostat 15 MG|After each instance of opening the BBB using specific parameters of focused ultrasound in the specific number of tumor sites (one, two, or three), the subjects will receive oral Panobinostat (15 mg/m^2).
15756586|NCT04804709|Device|Focused Ultrasound with neuro-navigator-controlled sonication|"The purpose of this study is to evaluate the feasibility of opening the BBB safely using specific parameters of focused ultrasound in progressive/recurrent diffuse midline gliomas in one, two, or three tumor sites. The trial will follow a 3+3 Number of Tumor Sites (NOTS) escalation scheme. The number of tumor sites in reference to here is the number of openings in the blood-brain barrier using Focused Ultrasound (FUS). Subjects will start the first cycle of the treatment arm with 1 tumor site and move on to incrementing NOTS levels if no dose-limiting toxicities (DLTs) are observed."
15756587|NCT04804696|Drug|Toripalimab|Patients received toripalimab 240 mg I.V. drip on days 1 and 22.
15756588|NCT04804696|Drug|Paclitaxel|Patients received paclitaxel of 175mg/m2 I.V. drip on days 1 and 22.
15756589|NCT04804696|Drug|Cisplatin|Patients received cisplatin of 70mg/m2 I.V. drip on days 1 and 22.
15756590|NCT04804683|Genetic|Genetic dissection of Fibromuscular Dysplasia|Blood sampling for genetic analysis aiming at unraveling the genetic basis of Fibromuscular Dysplasia
15756591|NCT04804683|Other|Search for diagnostic and prognostic biomarkers of Fibromuscular Dysplasia|Blood/urine and in rare cases tissue sampling aiming at identifying biomarkers of Fibromuscular Dysplasia
15756592|NCT04804670|Device|Power device A|Oral hygiene regimen completed daily
15756593|NCT04804670|Device|Power device B|Oral hygiene regimen completed daily
15756594|NCT04804670|Device|Routine Oral Hygiene|Oral hygiene regimen completed daily
15756595|NCT04804657|Dietary Supplement|Sage extracts Cognivia|Cognivia is composed of 400 mg of aqueous extract from Salvia officinalis and the remaining 200 mg contained 50 µL of Salvia lavandulaefolia essential oil and encapsulated with gum acacia. It will be administrated the the morning before the endurance test (oral administration).
15756596|NCT04804657|Dietary Supplement|Placebo|Made with maltodextrin. It will be administrated the the morning before the endurance test (oral administration).
15756597|NCT04804644|Drug|Memantine Hydrochloride|Given PO
15756598|NCT04804644|Other|Neurocognitive Assessment|Ancillary studies
15756599|NCT04804644|Radiation|Stereotactic Radiosurgery|Undergo SRS
15756600|NCT04804644|Radiation|Whole-Brain Radiotherapy|Undergo HA-WBRT
15756601|NCT04804631|Device|Enteral feeding tubes|Families within Great Ormond Street Hospital are offered the choice of two enteral feeding tubes prior to admission for bone marrow transplant. Some families choose a gastrostomy to be placed prophylactically in the weeks prior to admission, others choose a nasogastric tube to be placed during the admission.
15756602|NCT04804605|Drug|ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%|ARQ-151 Cream
15756603|NCT04804592|Device|Tactile Esthesiometer Prototype|A round plastic nozzle (1.8mm diameter) used as a stimulus for corneal sensation threshold measurement
15756604|NCT04804592|Device|Liquid Jet Esthesiometer Prototype|Balanced salt solution with a pH value similar to the tear film uesd as a liquid jet stimulus for corneal sensation threshold measurement
15756605|NCT04804592|Device|Cochet Bonnet esthesiometer|A nylon thread (0.12mm diameter) used as a stimulus for corneal sensation threshold measurement
15756606|NCT04804579|Behavioral|Fall Prevention Intervention|The intervention will aim to reduce fall risk through weekly virtual group meetings and at-home exercise assignments to address physical and environmental factors that may put participants at a higher risk of experiencing a fall.
15756607|NCT04804566|Other|This is a non-interventional study|This is a non-interventional study
15756610|NCT04804540|Drug|Vedolizumab IV|Vedolizumab IV infusion
15756611|NCT04804527|Other|Intensified physiotherapy|Physiotherapy x2
15756612|NCT04804527|Other|Usual care physiotherapy|Physiotherapy x1
15756613|NCT04804514|Drug|KH001|The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to KH001 or placebo in a ratio of 6:2 (6 active, 2 placebo).
15756614|NCT04804514|Drug|Placebo|The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to KH001 or placebo in a ratio of 6:2 (6 active, 2 placebo).
15756615|NCT04804501|Device|Blue Light Glasses|Participants will be randomized into an experimental group (blue light glasses) or a control group (no glasses). Participants will perform a computer reading task while either wearing, or not wearing the glasses.
15756616|NCT04804501|Other|Computer Reading Task|Participants will read on a computer until concussion symptoms increase by a score of 3 or more (reading task termination criteria). One or more points will be assigned for each increase in symptom severity, and one point will be assigned for each new symptom that appears.
15756617|NCT04804488|Procedure|nasal polyp surgery|A retrospective study for patients with recurrent nasal polypi operated at Otorhinolaryngology Department, Sohag University Hospital will be carried out.
15756618|NCT04804475|Other|Exercise Trainig|SSE is performed on a thin exercise mat divided into 40 small squares in 250 cm x 100 cm of size (25 cm each part). Participants are given patterns of a few steps and asked to take steps that match them. Participants must, in principal, move ahead in line with the length forward with no contact on the lines forming the squares. Forward, backward, lateral and oblique stepping patterns are required. Stepping patterns get increasingly difficult. Each pattern consists of 2 to 16 steps; participants are asked to repeat step pattern till the end of exercise mat. Upon completing a pattern, another pattern in the same mirror-image is repeated. In essence each pattern is reiterated for 3-5 times and next its mirror-image pattern is repeated but if participants face challenge in performing the pattern it is repeated till the pattern is learnt
15756619|NCT04804462|Device|Virtual Reality Meditation|After donning the VR headset, participants will be able to use a handheld controller to choose from several virtual outdoor settings, three types of meditation, and three session lengths. After choosing their desired option, participants will experience virtual reality meditation in the desired virtual location, of the desired meditation type, and for the allotted duration chosen.
15756641|NCT04804241|Drug|Senicapoc|10 mg oral tablet
15756642|NCT04804241|Other|Placebo Tablet|Placebo Oral Tablet
15756678|NCT04804046|Other|Digestible Maltodextrin|Eighteen participants with Crohn's disease that are undergoing an ileocecal resection will supplement their normal diet with Maltodextrin daily for six months.
15756620|NCT04804436|Genetic|Genetic analysis|he real-time PCR amplification was performed in a final volume of 20μL reaction mixture, including 10 ng of genomic DNA, 5 µL of TaqMan® Universal PCR Master Mix, and 0.5 µL of 40X TaqMan® assay. Thermal cycling conditions were as follows: initial denaturation at 94℃ for 3 min, 40 cycles of 94℃ for 15 s, and 60°C for 1 min. The Rotor-Gene Q Series Software Version Q 2.3.1 (Rotor-Gene Q Series, Ziagen) was used for allelic discrimination.
15756621|NCT04804423|Drug|38% Silver Fluoride and Potassium Iodide solution (generic name; Riva Star®)|38% silver fluoride will be applied to the surface of the isolated hypersensitive carious lesion followed by application of potassium iodide solution and according to manufacturer's instructions.
15756622|NCT04804423|Drug|Sodium fluoride varnish (generic name; Duraphat®)|22,600 ppm sodium fluoride varnish will be applied on the surface of the affected hypersensitive active carious lesions.
15756623|NCT04804410|Device|LCR Meter (Brand: Keysight, Serial Number:E498AL)|The LCR meter is used for electric property analysis of tissues. It works by measuring impedance on multiple sections of excised tissue and translating those measurement into dielectric properties.
15756624|NCT04804397|Dietary Supplement|Sucrose|Sucrose sweetened soft drinks
15756625|NCT04804384|Device|Prehension neuroprosthesis|"The experimental condition corresponds to patients in the condition where the prehension neuroprosthesis is active, which means that the extensor muscles of the fingers and thumb will be stimulated by the prehension neuroprosthesis to ensure the opening of the hand. The prehension neuroprosthesis designates a functional electrical stimulation device controlled by the patient which will itself trigger the stimulation of the extensor muscles of the fingers (closed-loop control), according to stimuli which it controls voluntarily. The goal is to restore an opening of the fingers to capture objects.
~The control condition corresponds to the patients in the condition where the prehension neuroprosthesis is inactive."
15756626|NCT04804371|Drug|F18-FDG|Evaluate FDG uptake
15756627|NCT04804358|Behavioral|Exposition Test|"During this test (7 minutes) participants will be exposed to photos evoking positive or negative emotions (anger, disgust, sadness and fear) interspersed with emotionally neutral photos.
~The test sequence is composed of 3 blocks as follows:
~12 photos evoking positive emotions (2 min)
~Pause of 30 seconds (white screen)
~12 photos presenting a neutral emotional valence (2 min)
~Pause of 30 seconds (white screen)
~12 photos evoking negative emotions (2min)
~In each block, photos will be selected and presented to the participant in a randomized and sequential manner. In total, 30 photos will be presented in 7 minutes to each participant (10 seconds per photo).
~The participant must be at rest in front of the computer screen during these 7 minutes with optimal visibility. The photos will be presented sequentially using software (E-Prime or Visual Basic 6.0). During this exposure test, a heart rate recording will be made using a BIOPAC MP160 recording system."
15756628|NCT04804345|Other|standard of care|retrospective study: standard of care
15756629|NCT04804332|Procedure|Operative hysteroscopy|Operative hysteroscopy is performed without or under local, regional or general anesthesia according to the local protocol preferably within 2 to 3 weeks after randomization. In case of highly vascularized RPOC, a repeat sonogram is performed 2 to 4 weeks after randomization to check for persistence of vascularity and to optimize operative timing. Operative hysteroscopy is then performed within 2 to 3 weeks after the repeat sonogram. Removal of the RPOC is performed by an experienced gynecologist using hysteroscopic morcellation (TruClearTM Hysteroscopic Tissue Removal System (Medtronic, Minneapolis, MN, USA)) and according to the local protocol.
15756630|NCT04804332|Other|Expectant management|No treatment will be offered. Patients will be given telephone numbers to contact a doctor. In case of severe complaints, defined as heavy uterine bleeding and/or severe abdominal pain, not responding to conservative treatment, an emergency curettage or operative hysteroscopy may be performed.
15756631|NCT04804319|Other|9-days habitual diet|9-days study with habitual diet including one standardized breakfast on a single day
15756632|NCT04804306|Device|Diagnostic Test: CBC-DIFF Monocyte Volume Width Distribution (MDW)|MDW measurement used to detect sepsis. Results will not be used to manage patients.
15756633|NCT04804293|Device|FDA approved ultrasound system with shear wave elastography capability|The investigators will acquire at least 4 acquisitions for each of 2 locations on the wrist. The objective is to correlate SWE measurements with patient-reported measures of symptom severity and functional status scores and severity of pre-operative electrodiagnostic tests (EDX). Evaluate the treatment response to surgical decompression or corticosteroid injection, using quantitative SWE and correlate the results to repeated patient reported outcomes with Boston CTQ, and objective clinical improvement with Semmes-Weinstein monofilament evaluation for recovery of sensibility, and grip and lateral pinch strength.
15756634|NCT04804280|Genetic|DNA methylation of target genes|The methylation status of target genes (BDNF, SLC6A4, OXTR, NR3C1) will be investigated. Cord blood will be collected at birth for PT and FT, only for PT a peripheral blood sample will be collected at hospital discharge, during routine clinical procedures. Genomic DNA will be extracted from aliquots of 0. 2 ml of each blood sample with the GeneElute Blood Genomic DNA kit (Sigma) and stored at -20°C. Aliquots of 250 ng of each DNA will be edited for methylation analysis with the EZ DNA Methylation Lightning kit (Zymo Research). Amplification of samples and their preparation for NGS sequencing will be performed. Samples will be sequenced on NextSeq 500 (Illumina). Individual processed sequences (PE reads) will be independently aligned to reference sequences using a parallel Smith-Waterman algorithm. Only reads that consistently align to the same reference sequence will be retained. At each CpG site in each analyzed sequence, the frequencies of the four bases will be evaluated.
15756635|NCT04804280|Diagnostic Test|Functional Magnetic Resonance Imaging (fMRI) acquisition|Infants will undergo an MRI exam with a 3 Tesla Philips Achieva scanner and a 32-channel head coil. a trained experimenter will apply tactile stimulation associated with affective touch characteristics to the child with a soft brush on the right anterior tibial region in proximal and distal directions. The length of the stimulated area will be measured to cover approximately 15 cm, and tactile stimulations will be applied at a rate of 5 cm/s for 15s, with randomized intervals between stimuli of 10-15s (resulting in 5 stimulations in a 15s block). A regular audio signal will help the researcher to keep a constant stroke velocity. Audio commands will also be used to direct the experimenter. Infant must be asleep (natural sleep) during the fMRI acquisition.
15756636|NCT04804267|Drug|Linaclotide|Manufactured by Jiangsu Hansoh Pharmaceutical Co., Ltd. Drug: Linaclotide 145μg orally once daily
15756637|NCT04804267|Drug|LINZESS®|Manufactured by Almac Pharma Services Limited Drug: Linaclotide 145μg orally once daily
15756638|NCT04804267|Drug|Placebo|Drug: Placebo orally once daily
15756643|NCT04804228|Other|Electrical dry needling|The experimental group consisting of 40 subjects will perform electrostimulation on the active myofascial trigger points of the following muscles: quadratus lumbar, multifidus and iliocostalis. The electrostimulation of the PGM will be carried out using needle electrodes, the generated current will be produced by a TENS device with a frequency of 2 Hz and a pulse width of 250 μs, the application will be approximately 30 min. The therapeutic intervention will be 1 session per week for a total of 3 weeks.
15756644|NCT04804228|Other|Ischemic compression, analytical stretching and postural habits educational dossier|The control group G2, formed by 40 subjects, will perform an ischemic compression technique in active PGM with a time between 20 seconds and 1 minute until pain inhibition is achieved, and finally, analytical stretching will be carried out on the quadratus lumbar, multifidus and iliocostal muscles, 1 weekly session for 3 weeks, in addition to providing them with a training dossier on postural education in their activities of daily life.
15756645|NCT04804215|Procedure|Intraductal transanastomotic stent group|When bile duct anastomosis is performed, a intraductal transanastomotic stent is inserted into the bile duct.
15756646|NCT04804215|Procedure|No stent group|Do not insert a stent into the bile duct during anastomosis of the bile duct.
15756647|NCT04804202|Other|Bicycling with and without virtual reality|In one session: Exercise intensity and enjoyment are measured while participants bicycle in a virtual compared to non-virtual environment. Cycling takes places in two modes continous and interval. In a second session exercise intensity and enjoyment are compared during bicycling with virtual reality presented in two different ways.
15756648|NCT04804189|Behavioral|The Reframe|Clubs will implement The Reframe's intervention into their community by (1) incorporating The Reframe materials into standard Club educational activities; (2) conducting a community- level Reframe event, led by Club adult and teen leaders; and (3) using social norms digital marketing materials.
15756649|NCT04804176|Device|Ultra-low frequency repetitive transcranial magnetic stimulation|Two different modes of the instrument were used to treat patients in groups, to compare the efficacy.
15756650|NCT04804163|Device|telesurgery by domestic robot|telesurgery of the upper urinary disease by domestic robot
15756651|NCT04804150|Device|Vacuum suspension system active or inactive|The device will be plugged in, or won't be plugged in, depending of the randomization. The patient and the investigator will not know whether the device is plugged in or not, and if the medical device is active or not
15756652|NCT04804137|Other|Blood|Blood samples are taken at each visit to the day hospital for a programmed injection of immunotherapy.
15756653|NCT04804137|Other|sputum|induced by saline aerosol sputum during each visit to the day hospital for a programmed injection of immunotherapy.
15756654|NCT04804137|Other|saliva|spontaneous saliva during each visit to the day hospital for a programmed injection of immunotherapy.
15756655|NCT04804137|Other|stool|Stool analyses will be carried out on a sample taken by the patient at home and brought back at the time of a day hospital.
15756656|NCT04804124|Behavioral|Regularized Sleep Schedule|Participants may maintain a self-selected 8-hour per night sleep schedule as an optional intervention. Participants from any of the three groups may complete the intervention.
15756657|NCT04804111|Drug|arm 0|placebo group
15756658|NCT04804111|Drug|arm 1|3 mg of the URC102 group
15756659|NCT04804111|Drug|arm 2|6 mg of the URC102 group
15756660|NCT04804111|Drug|arm 3|9 mg of the URC102 group
15756661|NCT04804111|Drug|arm 4|Febuxostat 80 mg
15756662|NCT04804098|Procedure|Compression Profile/Schedule: 15 minute Non-Linear compression from start of the daily treatment until treatment pressure is reached (45 fsw)|Patients will be compressed according to the 15 minute non-linear compression schedule on a rotating daily basis. A total of 2 randomized hyperbaric treatment compression profiles (accepted standards of care) will be alternated over the patients course of treatment on a daily basis daily to the prescribed treatment depth. There are multiple patients exposed during the compression profile randomized for that day. The patients are exposed over the course of 4-12 weeks using one of the two compression protocols to be studied on alternating days.
15756663|NCT04804098|Procedure|Compression Profile/Schedule: 15 minute Linear compression from start of the daily treatment until treatment pressure is reached (45 fsw)|Patients will be compressed according to the 15 minute linear compression schedule on a rotating daily basis with compression. A total of 2 randomized hyperbaric treatment compression profiles (accepted standards of care) will be alternated over the patients course of treatment on a daily basis daily to the prescribed treatment depth. There are multiple patients exposed during the compression profile randomized for that day. The patients are exposed over the course of 4-12 weeks using one of the two compression protocols to be studied on alternating days.
15756664|NCT04804072|Drug|Medication for opioid-use disorder (MOUD) for opioid-use disorder (OUD)|MOUD for OUD
15756665|NCT04804072|Diagnostic Test|HIV testing|HIV testing
15756666|NCT04804072|Drug|HIV treatment for HIV-positive participants not already in care|HIV treatment for HIV-positive participants not already in care
15756667|NCT04804072|Drug|PrEP for HIV-negative participants|PrEP for HIV-negative participants
15756668|NCT04804072|Diagnostic Test|Testing and referral for vaccination or treatment for hepatitis A virus (HAV) and hepatitis B virus (HBV)|Testing and referral for vaccination or treatment for HAV and HBV
15756669|NCT04804072|Diagnostic Test|Testing and referral for treatment for hepatitis C virus (HCV)|Testing and referral for treatment for HCV
15756670|NCT04804072|Diagnostic Test|Sexually transmitted infection (STI) testing and treatment|STI testing and treatment
15756671|NCT04804072|Other|Primary care|Primary care
15756672|NCT04804072|Behavioral|Harm reduction services|Harm reduction services
15756673|NCT04804072|Behavioral|Peer navigation|Peer navigation
15756674|NCT04804072|Diagnostic Test|COVID-19 testing and referral for further evaluation, care and/or treatment|COVID-19 testing and referral for further evaluation, care and/or treatment
15756675|NCT04804059|Drug|[14C]-APX001 Oral Solution|Total dose containing NMT 3.1 MBq (84.0 µCi) 14C
15756676|NCT04804059|Drug|[14C]-APX001 Solution for Infusion|Total dose containing NMT 3.4 MBq (93.0 µCi) 14C
15756677|NCT04804046|Dietary Supplement|Synbiotic|Eighteen participants with Crohn's disease that are undergoing an ileocecal resection will supplement their normal diet with three Bifidobacterium spp. (3x10^9 CFU) plus three dietary fibers (24 g fiber) daily for six months.
15756680|NCT04804033|Drug|Placebo|Matching placebo softgel capsule.
15756681|NCT04804020|Procedure|NC|The first ultrasound scan will be performed on the second to the fourth day of the menstrual cycle to identify any problem related to the patients' uterus or adnexa. The second ultrasound will be performed on the sixth day of the cycle. Daily ultrasound and serum estradiol and LH level evaluation will be performed when the mean diameter of the dominant follicle of ≥14 mm. LH surge initiation is defined as a concentration of 180% above the latest serum value available in that patient with a continued rise thereafter9 to a level of 20 IU/l or more10 detected by the ECLIA method (Roche Cobas® E 801, Roche Diagnostics, Germany). Embryo transfer will be scheduled by the time of the initiation of LH and embryo stages.
15756682|NCT04804020|Procedure|mNC|The first ultrasound scan will be performed on the second to the fourth day of the menstrual cycle to identify any problem related to patients' uterus or adnexa. A second ultrasound scan will be performed on the sixth day of the cycle; if there is at least one follicle with a diameter of ≥12 mm, an ultrasound scan will be performed daily. When the dominant follicle's mean diameter is ≥16 mm, human chorionic gonadotropin (Ovitrelle® 250 μg; Merck, Kenilworth, NJ, USA) will be injected to trigger ovulation. Embryo transfer will be scheduled by the time of the hCG injection and embryo stages.
15756683|NCT04804020|Procedure|AC|The endometrium is prepared using oral estradiol valerate (Valiera®; Laboratories Recalcine) 8 mg/day, ranging from the second or fourth menstruation day. The endometrial thickness will be monitored from day six onwards, and vaginal progesterone (Utrogestan®; Besins) 800 mg/day will be initiated when endometrial thickness reaches ≥7 mm. Estradiol exposure must be lasting for ≥9 days before progesterone administration. Embryo transfer will be scheduled by the time of the initiation of progesterone and embryo stages.
15756684|NCT04804007|Drug|Etoposide|etoposide will be provided with prescription for etoposide 50mg/m2 orally daily for 21 days out of 28 day cycles. Cycles will be repeated every 4 weeks for a total of 3 cycles.
15756685|NCT04803994|Drug|Atezolizumab|1200 mg atezolizumab intravenously Q3W (max 32 cycles, up to 24 months)
15756686|NCT04803994|Drug|Bevacizumab|15 mg/kg intravenously Q3W (max 32 cycles, up to 24 months)
15756687|NCT04803994|Procedure|TACE|Locoregional therapy will be performed as a standard-of-care procedure
15756688|NCT04803981|Other|SpoonfulONE|SpoonfulONE is a line of nutritional food products designed to help improve diet diversity starting in early infancy. SpoonfulONE covers a wide range of food proteins. Each product contains 30 mg of peanuts, milk, shellfish (shrimp), tree nuts (almond, cashew, hazelnut, pecan, pistachio, and walnut), egg, fish (cod and salmon), grains (wheat and oat), soy, and sesame.
15756689|NCT04803968|Other|bicycle ergometer and arm ergometer exercise|"After the bicycle ergometer training is completed, there will be a 15-minute break for blood pressure measurement of the patients.
~Then the combined upper and lower extremity training group will participate in the arm ergometer exercise separately from the lower extremity training group.
~For this, the patient will sit upright in front of the height-adjustable arm ergometer stand (Lode Angio Arm Ergometer with Automat) with the fulcrum of the handle at shoulder height.
~The arm endurance training group will work for a total of 20 minutes, at 60% of the peak workload and at 50 rpm."
15756690|NCT04803968|Other|bicycle ergometer exercise|All patients in the control and study groups will participate in the routine lower extremity bicycle ergometer training (Lode Corival Cpet Ergoline type: 960900 serial number: 20160094, Netherlands). The exercise protocol for the lower extremities will consist of a total of 40 minutes, including an 8-minute warm-up phase and an 8-minute cool-down phase. Exercise intensity, on the other hand, will be arranged as recommended in the European Society of Cardiology (ESC) 2020 guideline for chronic heart failure patients, at a workload corresponding to 70-80% of peak oxygen consumption (VO2peak), with a turnover rate of 60 cycles / min.
15756691|NCT04803955|Drug|16mg，KB|16mg,Q8h±3min,Day1-Day7
15756692|NCT04803955|Drug|Placebos|16mg,Q8h±3min,Day1-Day7
15756693|NCT04803929|Biological|anti-ILT3 CAR-T|Autologous T cells genetically modified with anti-ILT3 CAR
15756694|NCT04803903|Device|Flotraq Sensor with EV1000 incorporating the HPI algorithm|"The HPI algorithm is only available on the EV1000, Hemosphere and Flotrac monitoring systems and requires the use of a Flotrac sensor connected to an arterial line (Edwards Lifesciences Corp., Irvine, CA, USA). The Flotrac sensor has a splitter which enables the splitting of the arterial blood pressure signal to facilitate a blood pressure signal on both the anesthesia machine monitor (standard care) and the HemoSphere monitor (study).
~In the intervention arm we asked the anesthesiologist and anesthesia nurse to use the study treatment flowchart . If the HPI alarm goes off, which entails both a sound and a flickering light, we ask the anesthesiologist to act upon this alarm immedietaly. Use of the study treatment flowchart ensures that the anesthesiologist has to think about the underlying cause. The HemoSphere/EV1000 with HPI software has a second screen with variables that provide information about the underlying cause of the predicted hypotension."
15756695|NCT04803890|Procedure|"No-Touch Radiofrequency Ablation"|"No-Touch Radiofrequency Ablation Using Octopus Electrodes and Combined RF Energy Delivery Mode"
15756696|NCT04803877|Drug|Regorafenib 40 MG|For subjects age 18 and older, Regorafenib will be administered as 120mg oral once daily on days 1-21 of each 28-day cycle
15756697|NCT04803877|Drug|Regorafenib 20MG|For subjects younger than 18 years, Regorafenib will be administered as 72mg/m2/dose (rounded to the nearest 20mg, maximum dose of 120mg) oral once daily on days 1-21 of each 28-day cycle.
15756698|NCT04803877|Drug|Nivolumab|"For subjects age 18 and older, Nivolumab will be administered at 480mg IV over 30 min every 28 days.
~For subjects younger than 18 years, Nivolumab 3mg/kg (maximum dose 240mg) will be administered IV over 30 minutes on day 1 and 15 of each 28-day cycle."
15756699|NCT04803864|Drug|Roxadustat|Orally 100mg, 3 times per week for 2 weeks First dose administered immediately after successful PCI.
15756700|NCT04803851|Drug|Anlotinib plus AK105|Anlotinib： a multi-kinase inhibitor AK105： an anti-PD-1 antibody
15756701|NCT04803838|Other|No intervention|No intervention
15756702|NCT04803825|Other|Heavy Slow Exercises|"Load magnitude: A dumbbell as heavy as possible within the given repetitions and sets.
~Number of repetitions: week 1: 15 reps, Week 2-3: 12 reps, Week 4-5: 10 reps, Week 6-8: 8 reps, Week 9-12: 6 reps
~Number of sets: 3
~Rest between sets: 2 - 3 min.
~Number of exercise interventions: 2
~Duration of experimental period: 12 weeks
~Fractional and temporal distribution of the contraction modes per repetition and duration of one repetition: 3s concentric, 2s isometric: while change concentric/eccentric phase, 3s eccentric.
~Rest in-between repetitions: No
~Range of motion: Full range of motion
~Intervention frequency: 3 times a week, with minimum 48 h recovery time in-between."
15806193|NCT04399590|Other|Interficial Intelligence|Interficial Intelligence
15756703|NCT04803825|Device|Extracorporeal Shock wave therapy|Two thousand impulses of shock waves are applied to the painful tendon, with a pressure between 1.5 and 3.0 bar (depending on what the patient tolerates). We use a power hand piece that provides energy of 0.01-0.35 mJ/mm2
15756704|NCT04803825|Other|Information and advice|Information and advice are based on assessment and will comprise the standardized oral and written information. Participants will be educated regarding pain during and after activities and encouraged to be physically active. With only one session, there is great reliance on self-management. Thus, information and advice are made available through a handout.
15756705|NCT04803812|Other|"Remote SMS (short message service, also known as text message) delivery"|Assessing the comparative effects of SMS types (storytelling; resources/strategies; and a combination of both) on physician wellbeing.
15756706|NCT04803799|Other|Training Programme|Cognitive-motor dual task exercises corresponding to associations between different motor tasks and different cognitive tasks.
15756707|NCT04803786|Drug|Transition from Xyrem to Xywav|This is a single-group non-interventional study where participant's transitioning from Xyrem to Xywav will be observed. Investigational product (IP) or drug support or requested changes to their medication will not be provided to participants by Jazz Pharmaceuticals. The Xyrem and Xywav that the participants will take will be provided by the participant's health care provider.
15756708|NCT04803773|Device|"UFOGUIDE patient transducer"|The transducer is maintained by a flexible/rigid structure, consisting of a support base, and three to four feet forming an arch around the area to be treated. These feet exist in several lengths (10, 20, 30, 40 cm) depending on the area to be treated and can be easily mounted on the base by fast attachment. The structure is based on the principle of granular jamming: it is flexible in its normal state, and can be stiffened by the application of depression within the feet.
15756709|NCT04803760|Other|A self-administered questionnaire|A self-administered questionnaire will be used to screen Neck disability index, demographic information and ergonomic risk factors.
15756710|NCT04803747|Drug|Tranexamic acid (TXA)|TXA 1 gram bolus (2 grams for patients over 100 kg) intravenously (IV) administered within 10 minutes of the first surgical incision, followed by 1 additional gram given intravenously at 2-4 hours of surgery or prior to skin closure, at the discretion of the anesthesiologist (e.g. IV bolus at 2-4 hours of surgery, at skin closure, or the 1 additional gram given as a continuous infusion throughout the surgical procedure).
15756711|NCT04803747|Drug|Placebo (0.9 % Saline)|Placebo (0.9 % normal saline) 1 gram bolus (2 grams for patients over 100 kg) intravenously (IV) administered within 10 minutes of the first surgical incision, followed by 1 additional gram given intravenously at 2-4 hours of surgery or prior to skin closure, at the discretion of the anesthesiologist (e.g. IV bolus at 2-4 hours of surgery, at skin closure, or the 1 additional gram given as a continuous infusion throughout the surgical procedure).
15756712|NCT04803734|Drug|Albuterol Sulfate inhalation aerosol 108mcg per actuation|MDI, 2 puffs, single dose, fasting
15756713|NCT04803734|Drug|Proair HFA (albuterol sulfate) Inhalation Aerosol 90 mcg per actuation|MDI, 2 puffs, single dose, fasting
15756714|NCT04803708|Biological|TP-102|One mL of IP solution will be applied topically per cm3 of target ulcer. The titer of each bacteriophage in TP 102 is 1x10^9 plaque forming units per milliliter (PFU/mL).
15756715|NCT04803695|Diagnostic Test|Microbial biofilm diagnose|Usage of new microbiological methods for biofilm detection
15756716|NCT04803682|Behavioral|Preventive Intervention|Participate in ASPIRE and mentorship program
15756717|NCT04803682|Behavioral|Questionnaire Administration|Ancillary studies (pre and post questionnaire)
15756718|NCT04803669|Procedure|Intrument-assisted soft tissue mobilization technique|This technique; It is applied with the help of a tool made of stainless steel. The instrument is rubbed on the skin at an angle of about 30 degrees, creating a massage-like effect on the soft tissue (2 sessions per week and 5 minutes per session, 8 sessions in total for 4 weeks).
15756719|NCT04803669|Procedure|Conventional Treatment|Hotpack, TENS, Ultrasound and Exercise will be applied as conventional treatment methods.
15756720|NCT04803656|Other|Assessment of COPD patients|Assessments explained in the arm section were made as described in one session.
15756721|NCT04803630|Other|Quality-of-Life Assessment|Ancillary studies
15756722|NCT04803630|Other|Questionnaire Administration|Ancillary studies
15756723|NCT04803630|Procedure|Thermotherapy|Undergo thermal therapy
15756724|NCT04803617|Other|Assessment of pulmonary function and pectoralis muscle strength|In both groups, forced vital capacity (FVC), forced expiratory volume in one second (FEV1) and FEV1 / FVC ratio were measured with portable spirometer according to the guidelines of the American Thoracic Society (ATS) and the European Respiratory Society (ERS). Maximal inspiratory (MIP) and expiratory pressure (MEP) were evaluated with mouth pressure device as per ATS/ERS guidelines. Sensation of dyspnea was assessed with Modified medical council research scale. Pectoralis muscle strength were measured isometrically using with digital hand held dynamometer.
15756725|NCT04803604|Behavioral|CASCADE (CAre Supporters Coached to be Adept DEcision partners)|CASCADE (CAre Supporters Coached to be Adept DEcision partners) is a multicomponent, lay coach-led supportive care intervention designed to increase family caregivers' skills in providing decision support to individuals with advanced cancer. In a series of weekly, one-on-one, 15-20 minute, in-person or telephone sessions, family caregivers receive psychoeducation on principles of providing effective social support and decision partnering, decision support communication, and Ottawa Decision Guide training as well as monthly follow-up.
15756726|NCT04803591|Drug|Tranexamic Acid|Tranexamic Acid will be administered as an injectable solution (500mg/5ml or 1000mg/10ml).
15756727|NCT04803578|Other|Conventional physiotherapy|The subjects will receive rehabilitation according to the guidelines on the management of subjects after knee or hip arthroplasty, recovery of joint Range of Motion, recovery of lower limb strength, education to the crutches management, and stairs climbing and descending
15756728|NCT04803565|Device|Custom-made shoe insole|Subjects will receive a custom-made shoe insole designed on the patient's foot and shoes. The subjects should wear the insole for at least 6 hours per day.
15756729|NCT04803565|Device|Sham conventional Insole|Subjects will receive a conventional insole without any specific property (sham insole)
15756760|NCT04803279|Device|Collection of Pure tone thresholds from audiogram measured prior to fitting of Ponto 3 SuperPower|Unmasked and if available masked BC thresholds from audiogram obtained prior to Ponto 3 SuperPower were fitted.
15756952|NCT04802161|Drug|Liposome-encapsulated Daunorubicin-Cytarabine|Given IV
15756730|NCT04803552|Device|Overnight sleep study with Sleepiz One and a respiratory polygraphy|"Participants will undergo a screening night with Sleepiz One. and with a cardiorespiratory polygraphy device (Miniscreen, Heinen-Löwenstein).
~Measurements (Miniscreen, Heinen-Löwenstein)
~Thoracic respiratory effort: respiration frequency (BR), respiration curve
~Airflow: respiration frequency (BR), respiration curve
~Body movement: body position
~Blood oxygen saturation (SpO2)
~Pulse
~Measurements (Sleepiz One):
~• Movement originating from breathing and heart contractions"
15756731|NCT04803539|Drug|capecitabine|capecitabine is proved to improve 5-year disease-free survival among women with early-stage triple-negative breast cancer who received standard adjuvant treatment(The SYSUCC-001 Randomized Clinical Trial)
15756732|NCT04803539|Drug|capecitabine + camrelizumab + apatinib|Camrelizumab combined with apatinib is a safe and effective combination proved in patients with advanced TNBC in our early study
15756733|NCT04803513|Drug|Galcanezumab|Galcanezumab according to clinical indication in real life
15756734|NCT04803500|Drug|Simvastatin|single injection of simvastatin gel in the gap around immediately placed implant
15756735|NCT04803500|Drug|Placebo|single injection of the solid lipid nanoparticle carrier in the gap around immediately placed implant
15756736|NCT04803487|Other|robot-assisted cholecystectomy|cholecystectomy was performed for patients using the Chinese Micro Hand S surgical robot.
15756737|NCT04803487|Other|robot-assisted cholecystectomy|cholecystectomy was performed for patients using the da Vinci surgical robot.
15756738|NCT04803474|Diagnostic Test|Measurement of blood values, questionnaire scores and measurements of hormone levels in hair|Measurement of blood values, questionnaire scores and measurements of hormone levels in hair
15756739|NCT04803461|Diagnostic Test|serum and urinary catecholamines|estimation of level of serum and urinary catecholamines before and after excimer light treatment for patient with non segmental vitiligo.
15756740|NCT04803448|Behavioral|Benefit statement|"The participant reads this statement after asked one of eight health questions
~What is your height in inches?
~What is your weight in pounds?
~How many days out of the last 2 weeks did you drink alcohol?
~How often a month do you use other substance such as marijuana, cocaine, ecstasy, or other drugs
~How often a month do you use Rx or non-Rx medications to excessive amounts?
~When was the last time you smoked a cigarette?
~How many days in the last 2 weeks did you engage in more than 30 min exercise?
~How many times did you engage in sexual activity in the last month with another individual? . The statement reads: Accurately answering this will increase the likelihood of a correct diagnosis.
~An example of this with one of the 8 health questions is... What number of days in the last 2 weeks you engaged in >30 minutes of exercise? Accurately answering this will increase the likelihood of a correct diagnosis."
15756741|NCT04803448|Behavioral|Risk Statement|"The participant reads this statement after being asked one of eight health questions.
~The statement reads: Inaccurately answering this will increase the likelihood of an incorrect diagnosis."
15756742|NCT04803448|Behavioral|Privacy Statement|"The participant reads this statement after being asked one of eight health question for example. We will not share or sell this personal health information with anyone. We will comply with all HIPPA regulations regarding the protection of your data."
15756743|NCT04803448|Behavioral|Benefit + Privacy|"The statement reads Accurately answering this will increase the likelihood of a correct diagnosis. We will not share or sell this personal health information with anyone. We will comply with all HIPPA regulations regarding the protection of your data."
15756744|NCT04803448|Behavioral|Risk + Privacy|"The statement reads Inaccurately answering this will increase the likelihood of an incorrect diagnosis. We will not share or sell this personal health information with anyone. We will comply with all HIPPA regulations regarding the protection of your data."
15756745|NCT04803435|Other|Telemedicine Consultation|Brief telemedicine consultation, blindedto subsequent face-to-face evaluation.
15756746|NCT04803435|Other|Face-to-face Consultation|Direct face-to-face evaluation (without telemedicine consultation before).
15756747|NCT04803422|Drug|Antibiotic|The study aims to test whether oral antibiotics is non-inferior compared to intravenous antibiotics.
15756748|NCT04803409|Device|Splenic Ultrasound|Splenic Ultrasound: Daily ultrasound application to the spleen of approximately 18 minutes for up to 7 days, in addition to standard clinical care
15756749|NCT04803396|Drug|DF2755A|"DF2755A was planned to be administered in two different parts:
~Part A: Single oral dose administration on D1 according to the randomization (50, 150, 300 and 300 mg oad).
~Part B: was planned (100 mg bid, 200 mg bid or 300 mg bid) not performed (repeated oral administration from Day 1 to Day 14).
~Hence, only part A of the study was accomplished."
15756750|NCT04803383|Other|Tele-yoga|Tele-yoga training 3 days a week for 8 weeks
15756751|NCT04803370|Other|Convalescent Plasma with antibody against SARS-CoV-2.|"Convalescent plasma plus standard treatment for COVID-19. The convalescent plasma is from patients recovered from COVID-19 and negative viremia in the test detection COVID-19.
~The infusions will be given on days 1 and 2, of the study, after the positive result for COVID-19 of the recipient patient."
15756752|NCT04803370|Other|Standard treatment for COVID-19|The patients will receive the standard treatment for COVID-19, according to guidelines for COVID-19 (retrovirals drugs, interferon-α / β, anti-IL-6 monoclonal antibody, oxygen therapy, etc..)
15756753|NCT04803357|Device|Continuous glucose monitor|We are offering you an opportunity to wear a medical device that monitors your blood sugars (glucose). This device is called a continuous glucose monitor (CGM). The CGM measures glucose levels through a tiny plastic filament that is inserted under the skin in your abdomen by a skin prick. Typically, you cannot feel this device once it is inserted.
15756754|NCT04803344|Behavioral|Expressive Writing tecnique|Expressive Writing (EW), is a simple, potentially inexpensive, therapeutic intervention which involves writing daily for 15-20 min over 3-4 consecutive days. EW can be completed at home without the need for facilitation, a specialist therapist or a dedicated facility.
15756755|NCT04803344|Behavioral|Neutral Writing|Participants were asked to write on neutral objects or events.
15756756|NCT04803331|Diagnostic Test|SPIO-enhanced MRI|SPIO is peritumorally injected. A T2*-weighted iron sensitive MRI scan is performed 1 hour later to localize and assess the sentinel lymph nodes.
15756757|NCT04803318|Drug|Combination of three inhibitors Trametinib, Everolimus and Lenvatinib|Oral administration of three inhibitors including Trametinib, Everolimus and Lenvatinib.
15756758|NCT04803305|Drug|PF-06946860|subcutaneous injection
15756759|NCT04803305|Drug|Placebo for PF-06946860|subcutaneous injection
15756761|NCT04803279|Device|Collection of BC In-situ thresholds from BC In-situ audiogram measured during fitting of Ponto 3 SuperPower|BC In-situ thresholds will be collected from the BC In-situ audiogram obtained when Ponto 3 SuperPower were fitted
15756762|NCT04803279|Device|Collection of Aided sound field thresholds measured with the Ponto 3 SuperPower|Sound field thresholds for frequencies 500Hz, 1kHz, 2 kHz, 3kHz and 4kHz will be collected from sound field audiogram obtained as follow-up after Ponto 3 SuperPower fitting, typically this is collected 3 months post fitting, alternatively from the fitting visit. Thresholds will be obtained aided, and when available unaided
15756763|NCT04803279|Device|Collection of speech intelligibility scores|"Speech intelligibility is measured in a sound treated room using sentence tests. The sentence tests used at Norwich and Norfolk hospital is the BKB (Bamford-Kowal-Bench) and/or the The AB[s] Isophonemic Monosyllabic Word test (7).
~The sentence tests are measured in quiet and/or with background speech-weighted noise."
15756764|NCT04803279|Device|Skin reaction|Classification of skin reactions around skin penetrating implants will be made using the Holgers score. The Holgers classification is a scale from 0 to 4 that is used to grade skin reactions
15756765|NCT04803279|Device|Collection of Glasgow Benefit Inventory|The Glasgow Benefit Inventory (GBI) contains 18 health status questions, which ask specific questions about how the health problem, in this study hearing loss, has affected their quality of life at the time the GBI is completed. In this study GBI has been collected on patients before intervention and 3 months after fitting of Ponto 3 SuperPower on abutment.
15756766|NCT04803279|Device|Collection of power-on usage time with Ponto 3 SuperPower|Average power-on usage hours from Ponto 3 SuperPower will be collected.
15756767|NCT04803266|Radiation|Internal mammary node irradiation|Regional nodal irradiation including internal mammary node irradiation along with breast or chest wall irradiation after breast-cancer surgery
15756768|NCT04803266|Radiation|No internal mammary node irradiation|Regional nodal irradiation not including internal mammary node irradiation along with breast or chest wall irradiation after breast-cancer surgery
15756769|NCT04803253|Device|ORTHOPUS prosthetic accessory: 0109 - Universal Wrist|"The ORTHOPUS mechanical wrist device is intended to provide an external wrist joint only for external upper limb prostheses with pronation/supination passive motion (activation with external force), a quick connection (with automatic lock) and manual disconnection of the mechanical wrist connectors.
~The mechanical wrist connector allows to quickly switch between different type of terminal devices (hand or tools)."
15756770|NCT04803253|Device|ORTHOPUS prosthetic terminal device: 0112 - Hook|The ORTHOPUS body-powered hook is a Voluntary Opening (VO) device made of aluminium intended to provide high grasping capabilities under harsh environments.
15756771|NCT04803253|Device|ORTHOPUS prosthetic terminal device: 0105 - Cosmetic Articulated Hand|The ORTHOPUS cosmetic articulated hand is intended to provide a replacement limb in order to hide the loss of the original one. It is composed of an aesthetic glove (18 colors and 3 sizes, silicone made) and of an internal structure that can be bent to achieve a given position allowing the user to grasp small and light objects.
15756772|NCT04803253|Device|ORTHOPUS prosthetic accessory: 0104 - body powered harness|The ORTHOPUS body powered harness is intended to allow the patient to actuate the 0112 - Hook device. It will be installed on the patient's contralateral shoulder and linked to the 0112 - Hook device with a cable.
15756773|NCT04803240|Device|Thealoz Duo|Non applicable
15756774|NCT04803227|Drug|Emricasan|Emricasan 25 mg BID (days 1-14). Oral (capsule) administration.
15756775|NCT04803227|Other|Placebo|Placebo BID *days 1-14). Oral (capsule) administration.
15756776|NCT04803214|Device|ReActiv8|Market-approved ReActiv8 device implanted
15756777|NCT04803201|Drug|Cyclophosphamide|Given IV
15756778|NCT04803201|Drug|Doxorubicin|Given IV
15756779|NCT04803201|Drug|Vincristine|Given IV
15756780|NCT04803201|Drug|Prednisone|Given PO
15756781|NCT04803201|Drug|Etoposide|Given IV or PO
15756782|NCT04803201|Drug|Duvelisib|Given PO
15756783|NCT04803201|Drug|Oral azacitidine|Given PO
15756784|NCT04803188|Diagnostic Test|Magnetic Resonance|"Screening MRI examinations will be performed on an MRI General Electric (GE) 3 Tesla MRI using a 32-channel phased array pelvic coil. The imaging protocol will include: T2-weighted morphological and diffusion-weighted functional sequences.
~All images will be reviewed by two radiologists experienced in urogenital imaging, who will be blinded to the patients' medical history. Both radiologists in charge will then assign a PI-RADS score (1 to 5) to each lesion for bi-parametric MRI, representing the likelihood of a clinically significant prostate lesion. For the generation of the overall PI-RADS score assigned to each lesion, the PI-RADS score algorithm for non-contrast MRI described in the PI-RADS version 2.1 recommendations will be applied. Lesions scored as bPI-RADS superior or equal than 3 will be directed to MRI-TRUS guided targeted biopsy."
15756785|NCT04803175|Drug|Sacubitril-Valsartan|Participants will receive individualized dosage and titration as part of routine medical care, and a the effect will be studied for at least 12 months. The investigator does not assign specific interventions to the study participants.
15756786|NCT04803175|Drug|Valsartan|Participants will receive individualized dosage and titration as part of routine medical care, and a the effect will be studied for at least 12 months. The investigator does not assign specific interventions to the study participants.
15756787|NCT04803162|Diagnostic Test|High-resolution manometry|The parameters of high-resolution esophageal manometry will be compared between EoE patients and controls.
15756788|NCT04803162|Diagnostic Test|Serum biomarkers|The serum levels of IL-5, IL-13, TGF-β1, MBP and eotaxin 3 will be compared between EoE patients and controls.
15756789|NCT04803162|Diagnostic Test|Gastrointestinal Quality of Life index|The Gastrointestinal Quality of Life index (GIQLI) will be compared between EoE patients and controls.
15756790|NCT04803162|Drug|Omeprazole 20 MG Oral Tablet|The parameters of high-resolution esophageal manometry and serum levels of IL-5, IL-13, TGF-β1, MBP and eotaxin 3 will be compared in the group of patients with EoE at enrollment in the project and after 3 months of treatment with PPIs.
15756791|NCT04803149|Device|Cooled Radiofrequency|Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
15756792|NCT04803149|Device|Conventional Radiofrequency|Delivery of energy to ablate sensory nerves via standard or conventional radiofrequency probe
15756793|NCT04803136|Procedure|spine surgeries|all spine surgeries including stabilization and fusion surgeries
15756953|NCT04802161|Drug|Pomalidomide|Given PO
15756794|NCT04803123|Drug|Copanlisib|Patients must receive at least one dose of copanlisib prior to standard therapy to be evaluable.
15756795|NCT04803110|Procedure|Dental implant placement after tooth extraction|Immediate implant placement after partial or complete tooth extraction.
15756796|NCT04803084|Other|Tempus assay|Blood collection
15756797|NCT04803084|Other|Advanced pathology 1|Tissue procurement (from diagnostic biopsy)
15756798|NCT04803084|Other|Advanced pathology 2|Tissue procurement (from research biopsy)
15756799|NCT04803071|Dietary Supplement|Experimental group of n-pufas improving cognitive formula|Three times a day, one capsule of n-3pufas improvement cognitive formula capsule (once in the morning, in the evening) and routine treatment for depression, lasting for 12 weeks
15756800|NCT04803071|Dietary Supplement|General fish oil formula product adjuvant treatment control group|The control group: 1 capsule of general fish oil formula (once in the morning, in the evening) three times a day, plus routine treatment for depression, lasting for 12 weeks
15756801|NCT04803071|Dietary Supplement|Placebo assisted treatment group|Three times a day, one capsule of placebo adjuvant therapy (once in the morning, one in the evening) and conventional treatment of depression for 12 weeks
15756802|NCT04803058|Biological|TCD601|Investigational Product
15756803|NCT04803045|Other|Follow up email|Patients received an email 3 months after an initial consult asking why they had not returned to care. Patients were provided with 4 options and a space to write in comments. The email asked if the patient had any questions and offered support.
15756804|NCT04803032|Procedure|Superficial parotidectomy|The parotid gland was exposed with its capsule by subplatysmal and SMAS flaps. Dissection was performed from the tragal cartilage until the bony anterior wall of the external auditory canal; from there, the dissection was done using a blunt instrument. The styloid process's base is the upper point of the trident landmark; it is the superior portion of the trident landmark. Identification of the posterior belly of the digastric muscle till its origin was performed deep to the sternocleidomastoid muscle. ); it is the lower point of the landmark. The FNT is located in the region between these two structures. The dissection after identification of the main trunk of the facial nerve was similar to the routine parotidectomy. The surgical defect was closed over a removac suction drain using Vicryl materials; the skin was closed by 6-0 absorbable sutures. A dressing was applied to the surgical site. Then, a gauze was wrapped over the parotid area and secured around the forehead and neck.
15756805|NCT04803019|Combination Product|DEB-TACE|"The chemotherapy used in this arm is the Doxorubicin that will be carried into the tumor by Embozene TANDEM® (Boston Scientific) microspheres. TANDEM® embozene microspheres are made of non-resorbable, biocompatible, hydrogel microspheres, subjected to precision calibration and coated with an inorganic perfluorate polymer (Polyzene®-F).
~TANDEM® embozene microspheres are available in three different sizes, in 2 ml and 3 ml volumes of product and are supplied in preloaded vials and syringes.The maximum loadable amount on the hydrospheres 50 mg of Doxorubicina for ml. The maximum injectable dose of Doxorubicin for each treatment is 150 mg and therefore the maximum amount of microspheres that can be used for each treatment is 3 ml. The size of microspheres that will be used in this study is up to 100 ± 25 μm."
15756806|NCT04803019|Device|TAE|"The TAE will be performed with Embozene microspheres (Boston Scientific). Embozene microspheres are spherical particles of hydrogel, precisely calibrated, biocompatible, non-absorbable and coated with a perfluorinated inorganic polymer (Polyzene®-F). This medical device is available in various sizes; in this study, to avoid that the particle size exceeds the one used for the treatment of arm A, it will be possible to use microspheres with dimensions up to 100 μm (range 75 ± 125 μm).
~Embozene microspheres are offered in vials containing 1 ml of suspended product in physiological saline solution for apyrogenic sterile transport. The total volume of the Embozene microspheres, including the transport solution, is about 7 ml. To this product it is necessary to add an appropriate amount of non-ionic contrast medium in order to obtain a homogeneous suspension and with good visibility during the injection under fluoroscopy."
15756807|NCT04803006|Biological|TCD601|Investigational Product
15756808|NCT04802993|Other|Resection rates|All groups are divided into one high- and one low resection rate group depending on percentage of patients with pancreatic ductal adenocarcinoma resected per county and year (first three groups) and resection rate of pancreaticoduodenectomy per 100 000 inhabitants per county (last three groups)
15756809|NCT04802980|Drug|HB002.1T|HB002.1T is a vascular endothelial growth factor receptor decoy
15756810|NCT04802980|Drug|Oxaliplatin|Oxaliplatin is an anti-tumor drug
15756811|NCT04802980|Drug|Capecitabine|Capecitabine is an anti-tumor drug
15756812|NCT04802980|Drug|Paclitaxel|Paclitaxel is an anti-tumor drug
15756813|NCT04802980|Drug|Gemcitabine|Gemcitabine is an anti-tumor drug
15756814|NCT04802980|Drug|Cisplatin|Cisplatin is an anti-tumor drug
15756815|NCT04802980|Drug|Carboplatin|Carboplatin is an anti-tumor drug
15756816|NCT04802967|Drug|Ketoprofen Lysine Salt combined with Gabapentin|KLS-GABA (80 mg-34 mg) in Part A and KLS-GABA (40 mg-17 mg or 80 mg-34 mg or 160 mg-68 mg) in Part B
15756817|NCT04802967|Drug|Ketoprofen Lysine Salt|KLS (80 mg) alone in each treatment period in Part A and KLS alone (40 mg, 80 mg, or 160 mg) in Part B
15756818|NCT04802967|Drug|Gabapentin|300 mg
15756819|NCT04802967|Other|Placebo|2 capsules to maintain the blind
15756820|NCT04802954|Other|Video acquisition|One to three video acquisitions of 10 seconds will be carried out via the intercostal route. Data acquisition will be standardized according to a mandatory protocol and previously recorded in each ultrasound machine (cross shots, harmonic, filter, depth, focal length, mechanical index, etc.).
15756821|NCT04802941|Device|Neoadjuvant Chemotherapy by CDSS (MedicBK)|CDSS (MedicBK) captures the patient-specific data required to determine appropriate care decisions from the EMR and then presents relevant data alongside treatment suggestions to clinicians. MedicBK uses algorithms for presenting treatment suggestions framed by guideline-based therapy and personalized personalized evidence-based therapy. MedicBK consists of three main blocks: database, network meta-analysis, and heterogeneity of treatment effects assessment.
15756822|NCT04802941|Drug|General practice|General practice
15756823|NCT04802928|Drug|Isoniazid 300 milligram|Tablets 150 milligram b.i.d.
15756824|NCT04802928|Drug|Placebo|Placebo
15756825|NCT04802915|Procedure|Intraoperative ERM and ILM staining with their assessment and removal|ERM and ILM staining is performed after vitrectomy. After that we evaluate the condition of macular zone and make a decision to remove the ERM and the need to remove the ILM
15756826|NCT04802902|Other|home-based hospitalization|management in a hospital-at-home programme of patients treated by immunotherapy and chimiotherapy combo for bronchial cancer
15756827|NCT04802889|Other|scanning electron microscopy|scanning electron microscopy of the сentral retina and preretinal structures
15756828|NCT04802876|Drug|Spartalizumab|Spartalizumab (PDR001) 400mg will be given intravenously every 28 days
15756829|NCT04802863|Drug|XNW4107, Imipenem/Cilastatin|Five doses of 250 mg XNW4107 in combination with 500 mg imipenem/500 mg cilastatin
15756830|NCT04802850|Other|Mulligan mobilization with movement|
15756833|NCT04802824|Other|PET/CT|18F-fluoropivalate PET/CT scan.
15756840|NCT04802798|Dietary Supplement|Fibre 1|Food derived fibre presented as a white powder
15756841|NCT04802798|Dietary Supplement|Fibre 2|Food derived fibre presented as a white powder
15756842|NCT04802798|Dietary Supplement|Placebo|Simple sugar, presented as a white powder
15756843|NCT04802785|Drug|Citicoline|Citicoline 500 mg (Vitaae®) per os
15756844|NCT04802785|Drug|Cytochrome C6|Cytochrome10 mg per os
15756845|NCT04802785|Drug|Sodium Chloride Oral Product|Sodium Chloride (NaCl) 2.6 g. per os
15756846|NCT04802785|Drug|Potassium Chloride Oral Product|Potassium Chloride 1.5 g per os
15756847|NCT04802785|Drug|Sodium Citrate Oral Product|Sodium Citrate 2.90 g per os
15756848|NCT04802785|Drug|Dextrose Oral Tablet, Chewable|Dextrose 13.5 g per os
15756849|NCT04802785|Drug|Domperidone Oral Product|Domperidone 1 tablet per os
15756850|NCT04802785|Drug|Simethicone|3-4 capsules per os
15756851|NCT04802785|Drug|Acetylsalicylic acid|Acetylsalicylic acid 150 mg per os
15756852|NCT04802785|Drug|Magnesium hydroxide|magnesium hydroxide 30 mg per os
15756853|NCT04802785|Drug|Probiotic Formula|1 capsule per os.
15756854|NCT04802785|Drug|Melatonin 5 mg|Melatonin 5 mg per os.
15756861|NCT04802746|Drug|Alprazolam|Study participants will receive Staccato alprazolam Dose 1 and Staccato alprazolam Dose 2 at pre-specified time points in Part A. Study participants will receive single dose of Staccato alprazolam at pre-specified time points in Part B.
15756862|NCT04802746|Other|Placebo|Study participants will receive Staccato placebo at pre-specified time points in Part A and Part B matching the pre-specified Staccato alprazolam dosing.
15756867|NCT04802707|Combination Product|deoxycytidine and deoxythymidine|The Investigational Product (IP) dC/dT100-400 will be administered orally every day (QD) and the dose is divided over 3 taking/day for the daily dose of 100 mg/kg from Day 1-7, 200 mg/kg from Day 8-14, 300 mg/kg from Day 15- 21 and 400 mg/kg from Day 22 to 182. Doses was chosen according to the safety and efficacy doses used in the literature.
15756868|NCT04802694|Device|Water-based barrier tape|"The infants in experiment 1 group will be applied water-based barrier tape. The area will be covered by water-based barrier tape to fix nasogastric tube and after waiting 1 minute for drying up it will be fastened by silk tape used in clinic. The silk tape will be 5 cm long and it will be changed in every 24 hours. Following the removal of silk tape on the water-based barrier tape, the skin integrity of the infants will be evaluated through Neonatal Skin Condition Score Scale and the score will be recorded in the chart. Water-based barrier tape will be applied to the area every time the plaster will be changed and current skin condition score will be noted to the chart."
15756954|NCT04802148|Procedure|membrane guided regeneration|after tooth extraction, the socket was filled with membrane and graft (FDBA)
15807517|NCT04388111|Drug|Morphine|10mg of Morphine delivered Intraosseously
15756869|NCT04802694|Device|Hydrocolloid barrier tape|"As for experiment 2 group, hydrocolloid barrier tape will be used to fix the nasogastric tube. The hydrocolloid barrier tape, which was cut and shaped appropriately beforehand, will be applied to the area in order to stabilize the nasogastric tube and the tube will be stabilized with silk tape used in clinic. The silk tape will be 5 cm long and it will be changed in every 24 hours. Following the removal of silk tape on the hydrocolloid barrier tape, the skin integrity of the infants will be evaluated through Neonatal Skin Condition Score Scale . Since the hydrocolloid barrier tape can stay on the skin for 7 days and be transparent, the assessment of skin condition will be realized for 7 days and noted down to the chart."
15756870|NCT04802694|Device|Silk tape|"The silk tape used in clinic routinely will be used for control group infants to fix the nasogastric tube without any barrier. The silk tape will be 5cm long and it will be changed in every 24 hours. Following the removal of silk tape, the skin integrity of the infants will be evaluated through Neonatal Skin Condition Score Scale and the score will be recorded in the chart."
15756871|NCT04802681|Device|FFR-measurement with different pressure guidewires|Measuring FFR with different pressure guidewires
15756872|NCT04802668|Device|Patients were ventilated with assist-control ventilation（A/C） mode at different tidal volume :A/C-6ml/kg、A/C-8ml/kg、A/C-10ml/kg|Ventilation mode was set to assist-control volume ventilation with different tidal volume : 6ml/kg、8ml/kg and 10ml/kg; fraction of oxygen (FiO2) 40%-50%, respiratory frequency 15 times/min, PEEP 5centimeter water column.
15756873|NCT04802668|Behavioral|spontaneous breathing and no spontaneous breathing|Data were recorded when patients had and did not have spontaneous breathing
15756874|NCT04802668|Device|Patients were ventilated with pressure support ventilation（PSV） mode at different pressure support level:PSV1、PSV2、PSV3|Ventilation mode was set to pressure support ventilation with different pressure support level; fraction of oxygen (FiO2) 40%-50%, respiratory frequency 15 times/min, PEEP 5centimeter water column.
15756875|NCT04802655|Other|Video-game based exercise - Exergame|Selected Kinect compatible video games from Microsoft Xbox one will be applied in this group. Four video games will be selected for a session (each game will last 10 mins). Video games are active video games which participants have to use their body parts in order to control games.
15756876|NCT04802655|Other|Activity Based Exercise Group (AG)|Task-oriented exercises to be performed in standing and sitting positions, including upper extremity and trunk, will be applied to the activity-based exercise group in addition to routine NDT training. Examples for activities; stepping and putting stickers on the wall, treading the play dough placed on a step board within one leg stance; reach-grasp activities progressively from sitting to standing, throwing and catching balls on a balance board.
15756877|NCT04802642|Other|Survey|Survey
15756878|NCT04802629|Device|Near-infrared spectroscopy|For NIRS measurements the t-NIRS 1 and NIRO 200 NX (Hamamatsu, Japan) will be used. A cerebral sensor will be placed and fixed with a CPAP (Continuous Positive Airway Pressure) cap on the left forehead and a peripheral sensor on the right forearm. Duration of measurement will be two hours.
15756879|NCT04802616|Drug|Ismigen|Sublingual tablets containing 7 mg of bacterial lysate from the following bacteria: Staphylococcus aureus, Haemophilus influenzae serotype B, Klebsiella pneumoniae, Klebsiella ozaenae, Neiserria catarrhalis, Streptococcus viridans, Streptococcus pyogenes, Streptococcus pneumoniae (6 strains: TY1/EQ11, TY2/EQ22, TY3/EQ14, TY5/EQ15, TY8/EQ23, TY47/EQ24).
15756880|NCT04802616|Drug|Placebo|Matched tablets without any active substance.
15756881|NCT04802603|Radiation|Spine stereotactic body radiotherapy|"Cohort 1 - De novo: Spine stereotactic body radiotherapy to a dose of 40 Gy in 5 fractions.
~Cohort 2 - Prior radiotherapy: Risk-adapted spinal cord tolerance based on prior spine stereotactic body radiotherapy to a dose of 40 Gy in 5 fractions."
15756882|NCT04802590|Drug|Ibrutinib 560 mg|560mg/d continuously from C1D2 to end C24
15756883|NCT04802590|Drug|Venetoclax 10 MG Oral Tablet [Venclexta]|20mg/d from C2D1 to C2D7
15756884|NCT04802590|Drug|Venetoclax 50 MG Oral Tablet [Venclexta]|50mg/d from C2D8 to C2D14
15756885|NCT04802590|Drug|Venetoclax 100 MG Oral Tablet [Venclexta]|100mg/d from C2D15 to C2D21 200mg/d from C2D22 to C2D28 400mg/d from C3D1 to end C24
15756886|NCT04802577|Diagnostic Test|FACT-F questionnaire|The questionnaire, based on patient report outcome data in which the presence of fatique is investigated in participants.
15756887|NCT04802577|Diagnostic Test|Beck Depression Inventory|The questionnaire, based on patient report outcome data in which the presence of depression is investigated in participants.
15756888|NCT04802577|Diagnostic Test|Beck Anxiety Inventory|The questionnaire, based on patient report outcome data in which the presence of anxiety is investigated in participants.
15756889|NCT04802577|Diagnostic Test|Insomnia severity index.|The questionnaire, based on patient report outcome data in which the presence of insomnia is investigated in participants.
15756890|NCT04802577|Other|ESSPRI|The questionnaire, based on patient report outcome data in which the severity of Sjögren's syndrome is investigated in participants.
15756891|NCT04802577|Other|ESSDAI|Activity scale in which the activity of Sjögren's syndrome is evaluated based on the laboratory and imaging tests of the patients and the examination findings of the evaluator.
15756892|NCT04802577|Other|Pain Detect Questionnaire|The questionnaire, based on patient report outcome data in which the severity and extent of pain in the body are investigated in participants.
15756893|NCT04802564|Other|regular hand therapy|edema control, scar management, stretching regimen, tendon gliding exercise, blocking exercise, muscle strengthening protocols
15756894|NCT04802551|Other|Sensory integration therapy|Sensory integration disorder is defined as the inability of a person to use the information he / she receives through his / her senses properly in order to continue his daily life properly. Intervention group have some therapy sessions which include sensory integration therapy exercises.
15756895|NCT04802538|Device|OstoRing®|Participants will use the OstoRing® along with their standard pouching equipment.
15756896|NCT04802525|Other|Moderate-intensity aerobic exercise training|The first group has received Moderate-intensity aerobic exercise training without dietary control, the second group has received a low-fat diet program without exercise intervention, and the third group has received Moderate-intensity aerobic exercise training plus a low-fat diet program for 10 consecutive weeks
15756897|NCT04802512|Procedure|validity and reability study|validity and reliability assessment of the Turkish version of the Telehealth Usability Questionnaire (TUQ)
15756898|NCT04802499|Procedure|Turkish Reliability and Validity of TESS|Translation and cultural adaptation of the scale will be designed according to the appropriate procedure. Turkish data will be uploaded in the online online method. The scale will be communicated online to those who have received telerehabilitation services, caregivers and healthcare professionals who have applied it. The reliability of the questionnaire will be made by test-retest and internal consistency analysis. Volunteers will be asked to answer the questionnaire online after 5 days. After two weeks, the participants will be asked to answer the questionnaire again with the same method online with 5 days intervals. After all data are collected, validity analysis will be performed
15756899|NCT04802486|Other|EXCAP©®|EXCAP©® is a home-based low-to-moderate intensity program that employs a tailored walking prescription and total body resistance exercises
15756900|NCT04802473|Procedure|Mucogingival surgery|In brief description, Tunnel+acellular dermal matrix treatment will be performed by starting initial sulcular incisions, tunneling knives will be used to elevate the buccal gingiva by means of a full-thickness flap elevation. Flap preparation will be extended beyond the MGJ. The exposed root surfaces will be treated with pre-conditioning EDTA (Straumann PrefGel®) for 2 minutes. ADM (OrACELL, LifeNet Helth, Virginia Beach, VA, USA) of 1.25-1.75mm in thickness will be cut to the exact size of the defect, and will be inserted into the tunnel, and subsequently covered advancing the flap by means of sling sutures to stabilize the flap in a coronal position (6-0 Polypropylene, Prolene, Ethicon, Johnson and Johnson, New Brunswick, NJ, USA). Sutures will be removed after 14 days. Two weeks after surgery, patients will resume mechanical tooth cleaning with a soft toothbrush. Patients will be recalled at 1, 3 and 6 months for professional oral hygiene procedures.
15756901|NCT04802460|Device|Virtual reality headset (The Guided Meditation VR App through Oculus Go headset)|Patients assigned to the VR condition will engage with the VR using The Guided Meditation VR App through Oculus Go headset. They will enjoy up to a 10 minute video of an environment of their choosing. During this video they will listen to calming music and a guided meditation session.
15756902|NCT04802447|Drug|SurVaxM|Each participant will receive 4 doses of SVN53-67/M57-KLH (SurVaxM) spaced two weeks apart. This phase of treatment is known as the prime-boost phase and will take 6 weeks to complete. After completion of the prime-boost phase of treatment, the participant will receive a dose ofSVN53-67/M57-KLH (SurVaxM) every 3 months for up to two years
15756903|NCT04802434|Behavioral|Strengthening Skills Program|The Strengthening Skills Program is a new, multi-component intervention. It includes three components: (1) Forming habits to compensate for the difficulties many adults with ASD have with thinking flexibly, planning, and time management. It will emphasize habit-forming behaviors to compensate for weaknesses in functional skills by training on practical techniques; (2) Content from the PEERS Social Skills program to target social challenges, and (3) strategies derived from Mindfulness Based Stress Reduction to target emotion regulation.
15756904|NCT04802434|Behavioral|PEERS Social Skills Program|PEERS® is a well-established social communication training program, initially developed for adolescents, and more recently extended to young adults with ASD. Program content will be adapted slightly so as to be appropriate for older adults.
15756905|NCT04802421|Procedure|alveolar recruitment manoeuver|alveolar recruitment manoeuver are recommended during general anesthesia to prevent pulmonary atelectasis
15756906|NCT04802408|Combination Product|Shampoo and saline|Nasal washes with 1% baby shampoo solution and oropharyngeal gargles with saline solution
15756907|NCT04802408|Combination Product|Saline and Listerine|Nasal washes with buffered saline solution and oropharyngeal gargles with Listerine Antiseptic® solution
15756908|NCT04802408|Combination Product|Shampoo and Listerine|Nasal washes with 1% baby shampoo solution and oropharyngeal gargles with Listerine Antiseptic® solution
15756909|NCT04802408|Combination Product|Saline and Saline|Nasal washes with buffered saline solution and oropharyngeal gargles with saline solution
15756910|NCT04802395|Diagnostic Test|KidneyIntelX|KidneyIntelX is an in-vitro diagnostic that enables accurate risk prediction of progressive decline in kidney function in patients with type 2 diabetes and existing CKD at stages 1-3 (eGFR of 30 to 59 ml/min/1.73m2, or eGFR ≥ 60 ml/min/1.73m2 and uACR ≥ 30 mg/g).
15756911|NCT04802382|Drug|Placebo administration|patients will receive the placebo treatment in addition to Standard of Care
15756912|NCT04802382|Diagnostic Test|Confirm SARS-CoV-2 infection|patients will be tested for SARS-CoV-2 on days 1, 14 and 28
15756913|NCT04802382|Procedure|Physical Examination|patients will undergo a physical examination on days 1-14 and day 28
15756914|NCT04802382|Procedure|Vital Signs|patient's vital signs will be measured on days 1-14 and day 28
15756915|NCT04802382|Diagnostic Test|Hematology blood test|patients will provide a blood sample for a hematology blood test on days 1-14 and day 28
15756916|NCT04802382|Diagnostic Test|Biochemistry blood test|patients will provide a blood sample for a biochemistry blood test on days 1-14 and day 28
15756917|NCT04802382|Other|NEWS score|patient's NEWS score will be evaluated on days 1-14 and day 28
15756918|NCT04802382|Diagnostic Test|PK test|PK test will be performed on day 1 only (only in Brazil sites)
15756919|NCT04802382|Diagnostic Test|blood test for inflammatory markers|patients will provide a blood sample for an inflammatory markers blood test (IL-6, IL-1β, IL-12, TNF α, IFN-γ) on days 1-7, day 14, and day 28
15756920|NCT04802382|Diagnostic Test|D-dimer test|patients will provide a blood sample for D-dimer blood test on days 1, day 2, day 7, day 14, and day 28
15756921|NCT04802382|Other|VAS scale|patient's VAS scale will be evaluated on days 1-14, day 21, and day 28
15756922|NCT04802382|Diagnostic Test|Urine pregnancy test for women of childbearing potential|patients will provide a urine sample for a urine pregnancy test on days 1, and day 28
15756923|NCT04802382|Procedure|ECG|patients will undergo an ECG examination on days 1, and day 28
15756924|NCT04802382|Other|COVID-19-Impact on Quality of Life Questionnaire|patients will answer the COVID-19-Impact on Quality of Life Questionnaire on days 1, 7,14,21 and 28
15756925|NCT04802382|Drug|CimetrA-1|patients will receive the study treatment, CimetrA-1 treatment in addition to Standard of Care
15756926|NCT04802382|Drug|CimetrA-2|patients will receive the study treatment, CimetrA-2 treatment in addition to Standard of Care
15756951|NCT04802174|Drug|Berzosertib|Participants meeting inclusion and exclusion criteria will receive lurbinectedin (on day 1) and berzosertib (on day 1 and 2) administered every 21 days (1 cycle), either in the in-patient or out-patient setting, until disease progression or development of intolerable side effects.
15756927|NCT04802369|Diagnostic Test|Diagnostic tests|Selected prognostic factors will be analyzed, among others: demographic data of the patient, physical examination, symptoms, etiology and history of arterial hypertension, co-morbidities, results of selected laboratory tests, selected electrocardiographic and echocardiographic data, patient's cooperation with the doctor, treatment applied, parameters in the spiroergometric study, non-invasive assessment for central arterial pressure waveform analysis and body mass analysis.
15756933|NCT04802343|Drug|BAY1817080|Oral, tablet.
15756934|NCT04802343|Drug|Placebo|Oral, tablet.
15756935|NCT04802330|Other|Questionnaire|Assessment of causes of FGM Beni Suef localities. 3. Explore the relationship between some of the social and demographic variables such as age, education, place of residence, marital status, religion and economic level and practice of FGM.
15756936|NCT04802317|Diagnostic Test|Identification of the composition of the intestinal microbiota|Identification of the composition of the intestinal microbiota
15756937|NCT04802304|Other|Beyond Bias Treatment|The intervention has three components: 1) a summit that includes impactful stories told to and by family planning providers that highlight the consequences of provider bias, 2) a forum for continued communication between providers, and 3) a rewards program where clinics in which providers exhibit less biased client interactions or who have improved the most towards this end will be rewarded with social recognition and a ceremony.
15756938|NCT04802291|Behavioral|HomeStyles-2: Obesity Prevention Program for Families with Children in Middle Childhood|Comparison of 2 educational interventions
15756939|NCT04802278|Biological|COVID-19 vaccine|Any COVID-19 vaccine
15756940|NCT04802265|Procedure|Epiretinal membrane surgery|"The surgery consists of a 23 or 25-gauge pars plana vitrectomy (PPV). The surgery was performed peri-bulbar anesthesia and could be combined with phacoemulsification.
~An intraocular dye is used to well visualized and facilitate ERM peeling. The ILM is not actively peeled. A search for iatrogenic breaks is performed towards the end of the procedure. Areas suspicious for breaks are treated with cryotherapy or peripheral endolaser."
15756941|NCT04802239|Other|Medical hypnosis group|"Hypnotic induction is performed according to a standard protocol and identical for all.
~A script will be written to give all the important steps. .Only the pleasant place and the characteristics of the analgesic glove will be different between the subjects .the procedure will follow the following protocol:
~State of calm at rest of 3 minutes.
~Hypnotic induction by catalepsy of the eyes guided by breathing.
~The hypnosis session takes place in safety place , with glove protect by dissociation and confusion techniques."
15756942|NCT04802239|Other|calm wake group|healthy volunteers will observe 3 minutes calm waking state before standardized thermal harmful stimulation
15756943|NCT04802226|Other|self exclusion procedure|self exclusion procedure( responsible gambling tool)
15756944|NCT04802213|Other|Rehabilitation exercise|Rehabilitation exercise use the methods that suggested by previous studies including finger wall climbing, pendulum exercise, and arms lifting.
15756945|NCT04802213|Device|joint mobilization device treatment|The joint mobilization treatment used the mobilization device that developed in this research.It is a device developed by using the design of the vibration force generated by the vibration mechanism and the technologies to simulate the mobilization of the shoulder joint.When the subject uses the device, first sit on a seat that can be adjusted according to the user's body shape and buckle the shoulder fixation device. Then use the specially designed shoulder movement setting mechanism of the device to set the user's shoulder movement and movement angle.The next step is to set the direction and magnitude of the vibration force applied by the device to the shoulder joint in accordance with the joint mobilization technique (posterior, anterior, and inferior) that the therapist or user intends to perform to achieve the effect of simulating joint mobilization and increasing joint mobility.
15756946|NCT04802213|Device|laser acupuncture device treatment|The laser acupuncture treatment use the laser acupuncture device that developed in this research. A gallium-aluminium-arsenide (GaAlAs, infrared laser) continuous wave diode laser device with a wavelength of 850nm (invisible), a power output of 100 mW, and a spot area of 0.07cm2 was used for laser acupuncture.When performing laser acupuncture treatment, the laser emitted by the device is irradiated on the selected acupuncture points .The acupuncture points (GB 21, LI 4, LI 11, LI 14, LI15, LI 16, SI 9, SI 10, SI 11, TE 14, and TE 15) were determined according to the literature regarding acupuncture application in shoulder pain based on traditional chinese acupuncture.
15756947|NCT04802200|Other|Data collect|Data collect following a vascular closure by MANTA
15756948|NCT04802187|Other|RADx CHCs testing intervention strategy|The study team will support partner CHCs to implement workflows with some combination of dedicated testing staff, off-site testing, outreach/communications to priority populations, and linkage with local contact tracing systems. Implementation support will take the form of practice facilitation, rapid cycle testing (by supporting CHCs to review their internal data to assess the impact of workflow changes), and expert consultation from the research team on testing technology and testing location design.
15756949|NCT04802187|Other|Usual care control|CHCs implement testing strategies in accordance with their usual supports.
15756950|NCT04802174|Drug|Lurbinectedin|Participants meeting inclusion and exclusion criteria will receive lurbinectedin (on day 1) and berzosertib (on day 1 and 2) administered every 21 days (1 cycle), either in the in-patient or out-patient setting, until disease progression or development of intolerable side effects.
15756955|NCT04802148|Procedure|collagen plug|after tooth extraction, the socket was filled with collagen plug
15756956|NCT04802135|Other|Survey|directive questionnaire administered during an individual face-to-face interview
15756957|NCT04802122|Drug|Sevoflurane inhalant product|Sevoflurane 8% / O2 100% with the vital capacity breathing method (vital capacity induction, VCI) will be used for induction to anesthesia and facilitate endotracheal intubation.
15756958|NCT04802122|Drug|Propofol Fresenius|Propofol 1,5mg/Kg, supplemented by fentanyl 2mcg/Kg and rocuronium 0,5mg/Kg and O2 100% will be for induction to anesthesia and facilitate endotracheal intubation. .
15756959|NCT04802109|Device|wearing level D personal protective equipment|rubber gloves + surgical face mask + general isolation clothing
15756960|NCT04802109|Device|wearing Level C personal protective equipment with N-95|"C-level protective clothing+ N95 mask + disposable protective clothing (Ten Quin Medial Apparel) + foot cover + rubber gloves + mask + general isolation clothing"
15756961|NCT04802109|Device|wearing Level C personal protective equipment with Powered Air-Purifying Respiratory|"C-level protective clothing+ N95 mask + disposable protective clothing (Ten Quin Medial Apparel) + foot cover + rubber gloves + mask + general isolation clothing+Powered Air-Purifying Respiratory"
15756962|NCT04802096|Other|inspiratory muscle training|Intensity of inspiratory muscle training will be set at 30% of maximal inspiratory pressure. Subjects in intervention experimental group will perform 15 breaths per set, 6 sets per day on daily basis. The intervention will be last for 8 weeks.
15756963|NCT04802096|Other|pulmonary rehabilitation|Pulmonary rehabilitation consists of aerobic exercise training, strength training, and education related to airway clearance and drug utilization. All of subjects will receive 8-week pulmonary rehabilitation.
15756964|NCT04802083|Biological|Eculizumab|Eculizumab 900-1200 mg will be administered intravenously.
15756965|NCT04802070|Drug|Autologous CIK|Lymphocytapheresis of the autologous ex-vivo CIK cell expanded in the Cell factory (4 dose levels)
15756966|NCT04802057|Drug|BIVV020|Pharmaceutical form: solution for injection
15756967|NCT04802031|Biological|Rapid Infusion Isatuximab|Given IV
15756968|NCT04802018|Device|Clinical decision support system based on non-invasive multimodal monitoring|Non-invasive multimodal vital signs monitoring with the wearabl to monitor for a period of 10 days after the date of positive diagnosis to COVID-19. The device will be linked to the Home App, which will allow the sending of temperature, HR and RR data to the server every 15 minutes a day and the notification of symptoms by the patient three times a day.
15756969|NCT04802005|Other|Aerobic Interval Training|The aerobic interval training group
15756970|NCT04801992|Device|MINI WELL Ready (SIFI SpA, Italy)|Implantation during cataract surgery of the progressive extended depth of focus intraocular lens for the posterior chamber to replace the crystalline lens in the correction of aphakia in adult patients.
15756971|NCT04801979|Diagnostic Test|Incremental Step Test|"Performance of the incremental step test (number of steps) for the assessment of exercise capacity. The step test will be designed according to the characteristics of other validated field tests - the walking tests (6-minute walk test and the incremental shuttle walking test) The step test will be performed on a 20 cm tall, single-step device with no handles. The criteria for stopping the test will be the same as described in standard operating procedures for the walking field tests, with the addition of the inability to follow the work rate for a period of 10 seconds.
~The main outcome of the test will be the highest number of steps and work rate achieved."
15756972|NCT04801966|Drug|Trametinib|2 mg per day, continuous
15756973|NCT04801966|Drug|Cobimetinib|60 mg/day for 21 days of a 28 day cycle
15756974|NCT04801966|Drug|Binimetinib|45 mg/twice a day, continuous
15756975|NCT04801966|Drug|Alpelisib|300 mg/day, continuous
15756976|NCT04801966|Drug|Vemurafenib|960 mg/twice per day, continuous
15756977|NCT04801966|Drug|Dabrafenib|150 mg/twicce per day, continuous
15756978|NCT04801966|Drug|Encorafenib|450 mg/day, continuous
15756979|NCT04801966|Drug|Palbociclib|125 mg/day, day 1-21 of a 28 day cycle
15756980|NCT04801966|Drug|Olaparib|300 mg/twice per day, continuous
15756981|NCT04801966|Drug|Ribociclib|600 mg/day, on day 1 -21 of a 28 day cycle
15756982|NCT04801966|Drug|Abemaciclib|150 mg twice/day, continuous
15756983|NCT04801966|Drug|Talazoparib|1 mg/day, on day 1 -28 of each 28 day cycle
15756984|NCT04801966|Drug|Nivolumab|240 mg IV once every 2 weeks
15756985|NCT04801966|Drug|Atezolizumab|1200 mg IV on Day 1 of a 21 day cycle
15756986|NCT04801966|Drug|Pembrolizumab|200 mg IV on day 1 of a 21 day cycle
15756987|NCT04801953|Drug|NiMODipine Injectable Solution|nimodipine solution is applied to cranial nerves during resection of vestibular schwannoma
15756988|NCT04801953|Other|Placebo|Sodium chloride solution is applied to cranial nerves during surgery
15756989|NCT04801940|Drug|Apixaban|Apixaban 2.5mg orally twice daily for 14 days.
15756990|NCT04801940|Drug|Atorvastatin|Atorvastatin 40mg orally once daily for 12 months.
15756991|NCT04801914|Procedure|Percutaneous biliary drainage|Collection of peripheral blood samples before and one month after percutaneous biliary drainage performed for patients with malignant obstructive hyperbilirubinemia for further molecular biochemical analysis (measurement of serum matrix metalloproteinase activity).
15756992|NCT04801901|Procedure|dTRA|Subjects randomized to the experimental arm will undergo coronary angiography and percutaneous coronary intervention using distal transradial access (dTRA)
15756993|NCT04801901|Procedure|fTRA|Coronary angiography and percutaneous coronary intervention using the forearm radial artery.
15756994|NCT04801888|Biological|Two doses of inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 and one dose Quadrivalent Influenza Vaccine on day 0 or day 28.|The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research & Development Co., Ltd., with a antigen content of 600SU/0.5ml. The Quadrivalent Influenza Vaccine manufactured by Sinovac Biotech Co.,Ltd. including 4 antigens H1N1, H3N2, BV and BY, 15μg for each, 0.5ml per dose.
15756995|NCT04801888|Biological|Two doses of inactivated SARS-CoV-2 vaccine at the schedule of day 0,28 and one dose Quadrivalent Influenza Vaccine on day 14.|The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research & Development Co., Ltd., with a antigen content of 600SU/0.5ml. The Quadrivalent Influenza Vaccine manufactured by Sinovac Biotech Co.,Ltd. including 4 antigens H1N1, H3N2, BV and BY, 15μg for each, 0.5ml per dose.
15757208|NCT04800198|Procedure|non-invasive ventilation|none, measurements only
15756996|NCT04801875|Other|Selected Exercise|The violin and ney groups performed a structured exercise training program 3 times a week for a total of 8 weeks. Adherence to the exercise training program was checked using a follow-up schedule to ensure regular participation of the musicians. The 8-week exercise training program was given with same physiotherapist under the same conditions. The every exercise session consisted of warm-up (3-5 min), main exercise (30-35 min) and cooling periods (3-5 min). The main exercise period was included ROM (10 min), stretching (5-7 min), isometric (5-10 min) and stabilization exercises (5 min).
15756997|NCT04801849|Drug|d-alpha-tocopherol|Participants will be assigned to take 200 IU, 400 IU, or 800 IU of vitamin E in matching capsules daily for 24 weeks
15756998|NCT04801849|Drug|Placebo|Participants will take a placebo vitamin E capsule daily for 24 weeks
15756999|NCT04801836|Drug|Estetrol monohydrate 15 mg|One Estetrol monohydrate (E4) 15 mg tablet once per day
15757000|NCT04801836|Drug|Placebo|One placebo tablet once per day
15757001|NCT04801823|Other|Home introduction|Cautious, graded introduction of individual tree nuts
15757002|NCT04801823|Other|Multi Nut oral food challenge|In hospital multi nut oral food challenge (almond, cashew, hazelnut, walnut)
15757003|NCT04801810|Other|Normobaric hypoxia|Low oxygen exposure to mimic ~8500 feet elevation (experimental).
15757004|NCT04801810|Other|Normobaric normoxia|Normal oxygen exposure to mimic sea level conditions (sham comparator).
15757005|NCT04801797|Drug|Cytarabine|Intravenous infusion
15757006|NCT04801797|Drug|Idarubicin|Intravenous infusion
15757007|NCT04801797|Drug|Daunorubicin|Intravenous infusion
15757008|NCT04801797|Drug|Liposomal daunorubicin and cytarabine|Intravenous infusion
15757009|NCT04801797|Drug|Venetoclax|Orally by mouth
15757010|NCT04801797|Drug|Azacitidine|Intravenous infusion
15757011|NCT04801784|Procedure|Increased net ultrafiltration with advanced hemodynamic monitoring|A net ultrafiltration rate of 100 ml/h or more will be applied during the first 72 hours of study participation. To insure the hemodynamic security of the intervention, it is associated with an advanced hemodynamic monitoring protocol which encompasses cardiac index, preload dependence assessment (using postural maneuvers), lactate levels and central venous pressure evaluation. The hemodynamic monitoring protocol allows the decrease or suspension of the neutral ultrafiltration rate in case of hemodynamic instability or of hemodynamic status considered at risk of worsening if net ultrafiltration rate is maintained.
15757012|NCT04801784|Procedure|Zero or near-zero net ultrafiltration|The active control group aims to represent the present standard of care of net ultrafiltration management in the first 72 hours of study participation in patients with critical illness. This will be performed by setting the net ultrafiltration rate to 0 up to 25 ml/h.
15757013|NCT04801771|Device|Inspire Upper Airway Stimulation (UAS) System|The Inspire UAS System is an implantable device that provides hypoglossal nerve stimulation for the treatment of obstructive sleep apnea.
15757014|NCT04801758|Other|Analytical Treatment Interruption|"Participants will stop taking their HIV medication and will stay off HIV medication unless and until the HIV levels in their blood show that their immune system is not controlling their HIV or they meet other ART re-start criteria as noted in section Detailed Description."
15757015|NCT04801745|Other|Healthy vegan diet|Participants will attend group lessons and individual nutrition counseling to help them adopt a healthy vegan diet.
15757016|NCT04801745|Other|My Plate - Low Purine|Participants will attend group lessons and individual nutrition counseling to help them adopt a balanced diet in accordance with my plate, and emphasis on choosing low purine options from the protein food groups.
15757017|NCT04801745|Other|Amla fruits|Participants will be provided with powdered amla fruits, and will be instructed to take 3g per day.
15757018|NCT04801732|Other|mulligan thoracic Sustained Natural Apophyseal Glides|"Extension Thoracic Sustained Natural Apophyseal Glides :
~Patient position: The patient sits astride the end of the table with hands placed behind the neck to protract the scapulae allowing access to the mid thoracic spine for the therapist's hand.
~Therapist position: Therapist stands on their most efficient side for a centrally applied Sustained Natural Apophyseal Glides.
~Therapist grasp: The therapist's mobilizing hand (ulnar border) will apply a cephalad glide in line with the facet joint plane of the involved spinal level and the other arm holds the thoracic wall above the level to be mobilized.
~Traction is applied prior to glide, which is achieved by therapist knee extension
~Repetitions: Three sets of ten repetitions will be done after a trial for the patient to be familial with the technique.
~and traditional treatment."
15757019|NCT04801732|Other|traditional treatments|"includes: Ice pack and Pendulum exercise and shoulder range of motion (elevation, depression, flexion, abduction, rotations).Stretching exercise for internal rotators and posterior capsule.
~Strengthening exercise will be isometric in nature include external shoulder rotators, internal rotators, biceps, deltoid, and scapular stabilizers (rhomboids, trapezius, serratus anterior, Latissimus Dorsi , and pectoralis major muscles)."
15757020|NCT04801719|Device|Habib™ EndoHPB; Boston Scientific, US; former EMcision Ltd., UK|Randomised patients in selected arm received endoluminal RFA by 8F catheter (Habib™ EndoHPB; Boston Scientific, US; former EMcision Ltd., UK) before stenting procedure. Repeated ablations were processed through stenotic areas of bile ducts (10W, 90-120s, Rita 1500, Angiodynamics Ltd), all drained biliary tracts were used for introducing catheter and performance of ablation. Ablation procedure was followed with uncovered self-expandable metal stent insertion.
15757021|NCT04801706|Diagnostic Test|Ultrasound|Association of each ultrasonographic parameter with FIGO clinical grading of placenta accreta and with histopathological diagnosis of placenta accreta in hysterectomy specimens
15757022|NCT04801693|Drug|BI 1819479|BI 1819479
15757023|NCT04801693|Drug|Placebo|Placebo
15757024|NCT04801680|Device|Mpact 3D metal cup|Subjects, among those whose clinical condition makes them eligible for a primary total hip arthroplasty, will be invited to participate to the study during preoperative visit. They'll receive the Mpact 3D metal cup device
15757025|NCT04801667|Biological|Coronavac|The CoronaVac is manufactured by Sinovac Life Sciences Co., Ltd. This vaccine contains the inactivated SARS-CoV-2 virus antigen and is administered intramuscularly.
15757026|NCT04801654|Diagnostic Test|blood sample|preoperative and at 6 months and 1 year follow-up after the surgery the patients will take a blood sample
15757027|NCT04801641|Drug|Placebo|Six placebo capsules taken orally twice daily
15757028|NCT04801641|Drug|Nabilone|Titrated to two 0.5 mg capsules and four placebo capsules taken orally twice daily (Low-Dose) OR Titrated to six 0.5 mg capsules taken orally twice daily (High-Dose)
15757029|NCT04801628|Device|Active Tecar|Active Tecar
15757030|NCT04801628|Device|Placebo Tecar|Placebo Tecar
15757031|NCT04801615|Other|Surgery|All patients in the database undergo surgery due to a suspicion of necrotizing soft tissue infections
15757032|NCT04801602|Diagnostic Test|Rapid diagnostic tests|To evaluate different RDTs that are commercially available internationally for detecting antigens or antibodies to Salmonella Typhi and use blood culture as standard for comparison.
15757033|NCT04801589|Drug|Dexmedetomidine|For patients in the dexmedetomidine group, dose will range from 0.2-2.0 mcg/kg/hr. For example, a 10 kg patient on an infusion of 1 mcg/kg/hr of dexmedetomidine would receive 10 mcg of study drug per hour. This dose range have been selected after literature review and discussions with critical care practitioners, investigational pharmacists, and the mini-MENDS study steering committee.
15757034|NCT04801589|Drug|Midazolam|For patients in the midazolam group, dose will range from 0.025-0.25 mg/kg/hr. For example, a 10 kg patient on an infusion of 0.15 mg/kg/hr of midazolam would receive 1.5 mg of midazolam per hour. This dose range have been selected after literature review and discussions with critical care practitioners, investigational pharmacists, and the mini-MENDS study steering committee.
15757035|NCT04801576|Other|Flouride in mouthrinses|Custom made toothpastes and mouthrinses that do or do not contain flouride as sodium fluoride in different concentrations.
15757036|NCT04801576|Other|Placebo mouthrinse|Mouthrinses without flouride
15757037|NCT04801563|Other|MDS and AlloHSCT|Allogeneic stem cell transplantation, based on TMLI and followed by infusion of donor regulatory T cells and conventional T cells and purified donor CD34+ hematopoietic stem cells
15757038|NCT04801550|Device|Millimeter waves local exposure|several blocks of somatosensory evoked potentials with or without Millimeter waves local exposure
15757039|NCT04801537|Other|normal body temperature and warm extremities|environmental temperature is set according to the standard method to keep normal body temperature and warm extremities
15757040|NCT04801537|Other|normal body temperature and cold extremities|environmental temperature is set according to the standard method to keep normal body temperature, but cold extremities
15757041|NCT04801524|Behavioral|Self-benefit|Participants will be reminded that the vaccine helps protect themselves from COVID.
15757042|NCT04801524|Behavioral|Prosocial-benefit|Participants will be reminded that the vaccine helps protect their family, friends, and community from COVID
15757043|NCT04801524|Behavioral|Early access|Participants will be reminded that they have early access to COVID-19 vaccine.
15757044|NCT04801524|Behavioral|Fresh start|Participants will be reminded that the vaccine offers the promise of a fresh start and chart a new path forward.
15757045|NCT04801511|Drug|Vitamin C|High-dose Intravenous Vitamin C will be delivered on the day of radiotherapy, in order to reduce the acute toxicity of chemoradiotherapy.
15757046|NCT04801485|Dietary Supplement|Myo-inositol|Active group receives myo-inositol 1 gram per day as well as health guidance about diet and exercise. From recruitment until OGTT.
15757047|NCT04801485|Dietary Supplement|Placebo|Placebo (similar appearance but not containing myo-inositol) 1 gram per day before meals. Similar health guidance about diet and exercise. From recruitment until OGTT.
15757048|NCT04801472|Other|Optimisation of dental implant sites protection from irradiation|"Optimal treatment plan validation after two dosimetric computer-tomography scans (with or without radiological guide) and visualisation of virtual dental implants on scanner images.
~Evaluation of toxicity, quality of life and dental implant survival rate"
15757049|NCT04801459|Procedure|Direction procedure of gastrointestinal anastomosis in Roux-en-Y reconstruction|In this study, intervention methods include two kind directions of gastrointestinal anastomosis in Roux-en-Y reconstruction after distal curative gastrectomy for gastric cancer. One is the isoperistaltic anastomosis, representing the peristalsis direction of remnant stomach and jejunal efferent loop was consistent. The other is the antiperistaltic anastomosis, representing the peristalsis direction of remnant stomach and jejunal efferent loop was opposite.
15757050|NCT04801446|Device|Soterix Medical 1X1 tDCS stimulator (active C-tDCS)|Patients will be randomized to active treatment (C-tDCS) vs sham stimulation in a 3:1 ratio. There will be 6 dose tiers, reflecting increasing intensity and duration of stimulation: Tier 1 - 1 mA, single 20 - min cycle; Tier 2- 2 mA, single 20 min cycle; Tier 3 - 1 mA, 2 cycles of 20 min/20 min off; Tier 4- 2 mA, 2 cycles of 20 min/20 min off; Tier 5 - 1 mA, 3 cycles of 20 min/20 min off; Tier 6 - 2 mA, 3 cycles of 20 min/20 min off.
15757051|NCT04801446|Device|Soterix Medical 1X1 tDCS stimulator (sham stimulation)|Patients will be randomized to active treatment (C-tDCS) vs sham stimulation in a 3:1 ratio. Patients in the sham stimulation arm at all the tiers will have the headgear and electrodes in place, and the switch for sham stimulation will be on, i.e. no prolonged electrical stimulation will be delivered.
15757052|NCT04801433|Other|Boleda Supramolecular Active Zinc Conditioner|Boleda Supramolecular Active Zinc Conditioner (Shanghai Ruizhi Pharmaceutical Technology Co., Ltd.): 30ml/bottle. Once a day for 4 weeks, apply topically to the scalp psoriasis area, gently massage for 15 minutes then rinse off with warm water.
15757053|NCT04801433|Drug|Capotetriol scalp solution|Capotetriol scalp solution: 30ml/bottle. Two times a day for 4 weeks, topically applied to scalp psoriasis.
15757054|NCT04801433|Other|Supramolecular Hydrogel|Supramolecular Hydrogel (Shanghai Ruizhi Pharmaceutical Technology Co., Ltd.): 30ml/bottle. Once a day for 4 weeks, apply topically to the scalp psoriasis area, gently massage for 15 minutes then rinse off with warm water.
15757055|NCT04801420|Biological|VLA15|a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate
15757056|NCT04801420|Biological|Placebo|PBS (Phosphate Buffered Saline)
15757057|NCT04801407|Procedure|percutaneous radiofrequency trigeminal rhizotomy|percutaneous radiofrequency trigeminal rhizotomy is a perctaneous procedure that ablate the sensory part of the nerve and
15757058|NCT04801407|Procedure|Microvascular decompression of the trigeminal nerve|Microvascular decompression is a procedure that decompress the nerve from vascular conflict
15757081|NCT04801225|Device|Non-invasive electromagnetic stimulation for acute stroke treatment|Bilateral electromagnetic stimulation to improve blood flow in ischemic regions of acute stroke as an adjunct to current standard-of-care
15757931|NCT04793932|Drug|short-course chemotherapy|other two months of chemotherapy after surgery
15757059|NCT04801394|Procedure|hernioplastic and insertion of FLaPp® composite mesh|"After the reduction of the large incisional hernia, the polypropylene transparent film of this mesh (lower flap) was sutured to the margins of the residual peritoneum and posterior rectus sheath as a neo-peritoneum; the macroporous light polypropylene layer (upper flap) was then sutured circumferentially with full-thickness transabdominal stitches in the retromuscular space."
15757060|NCT04801381|Procedure|Aquablation therapy|Aquablation is carried out with the AQUABEAM Robotic System®, PROCEPT BioRobotics, Redwood City, CA, USA
15757061|NCT04801381|Procedure|Transurethral laser enucleation|Transurethral laser enucleation is performed according to the standard established at the respective test center. Included laser techniques: Holmium laser (HoLEP) and Thulium laser (ThuLEP).
15757063|NCT04801355|Procedure|full-thickness laparo-endoscopic colon adenomas excision|Full-thickness laparo-endoscopic removal of colon adenomas will be performed as follows: an endoscopist during intraoperative colonoscopy visualize the neoplasm, intra-luminary marks the margins of resection and stop at this in some cases. In another one: endoscopist start full-thickness removal of this lesion then the abdominal team during laparoscopy, with using laparoscopic technique, performe full-thickness resection of intestine wall with the tumor. Speciment extracted intralumenary or via minilaparotomy. Defect of the intestinal wall is sutured intracorporeally using laparoscopic technic. Desuflation, suturing of trocar sites.
15757064|NCT04801355|Procedure|laparoscopic colon resection|Standard laparoscopic colon resection
15757065|NCT04801342|Radiation|Conformal Whole Brain Radiotherapy with Unilateral Hippocampal Avoidance|Conformal Whole Brain Radiotherapy 30 Gy in 10 fractions with Unilateral Hippocampal Avoidance using Intensity modulated radiotherapy, Volumetric arc therapy, or Tomotherapy
15757066|NCT04801342|Radiation|Conformal Whole Brain Radiotherapy with Bilateral Hippocampal Avoidance|Conformal Whole Brain Radiotherapy 30 Gy in 10 fractions with Bilateral Hippocampal Avoidance using Intensity modulated radiotherapy, Volumetric arc therapy, or Tomotherapy
15757067|NCT04801342|Drug|Memantine Hydrochloride|Start from day 1 of WBRT orally for 24 weeks and escalating doses over the first 4 weeks
15757068|NCT04801329|Drug|Vyndamax (tafamidis 61mg)|As prescribed in real world practice
15757069|NCT04801316|Behavioral|Steady Feet exercise programme|"Steady Feet (SF) is a 6-month community-based structured exercise programme aimed at improving physical strength and balance among older adults (aged 60 years and above) who are at high risk of falls.
~This exercise programme was developed by Changi General Hospital's physiotherapists and exercise physiologist from evidence found in the literature."
15757070|NCT04801316|Behavioral|Steady Feet Video|About an hour-long video showcasing the exercise steps of the Steady Feet exercise programme
15757071|NCT04801303|Drug|Calcitriol|Administration of Calcitrol 0.25mcg/24h for a year in Friedreich's Ataxia patients (n=20)
15757072|NCT04801303|Other|Blood analysis for frataxin's level measurement|"Five blood analysis in Friedreich's Ataxia patients: before starting the treatment, and after fifteen days, 4 months, 8 months and 12 months of the treatment.
~To validate the Frataxin's levels measurement, a blood analysis will also be done in two kind of controls for every Friedreich's Ataxia patient, only once at the beginning of the trial.
~The control groups will be composed by:
~Heterozygous Ataxia's Friedreich controls (a close relative of the patient, either a heterozygous sibling or one of the parents)
~Age- and gender-matched controls (supposedly non-heterozygous)."
15757073|NCT04801303|Diagnostic Test|Blood analysis for hypercalcemia's control|Five blood analysis in Friedreich's Ataxia patients for monitoring the hypercalcemia risk (with measurement of Calcium, D Vitamin, renal function, albumin, protein, phosphate, sodium and potassium) Before starting the treatment, and after fifteen days, at 4 months, 8 months and 12 months of the treatment.
15757074|NCT04801290|Procedure|TIPS insertion|Patients are included in the registry if they receive a transjugular intrahepatic portosystemic shunt at Hannover Medical School and provide written informed consent.
15757075|NCT04801277|Procedure|Electroacupuncture on acupoints vs sham points|Randomized double blinded clinical trial
15757076|NCT04801264|Drug|68Ga-PSMA|Intravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-PSMA. Tracer doses of 68Ga-PSMA will be used to image lesions of adenoid cystic carcinoma by PET/CT.
15757077|NCT04801264|Drug|1.85GBq (50 mCi) of 177Lu-EB-PSMA-617|Patients were intravenous injected with the dose about 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles.
15757078|NCT04801251|Diagnostic Test|Echocardiographic examination|Each patient included will undergo full cardiac physical examination and echocardiographic examination
15757079|NCT04801238|Procedure|LCBDE + LC|"Experimental group: Laparoscopic common bile duct exploration (LCBDE) + laparoscopic cholecystectomy (LC) is performed under full anaesthesia. Once the dissection has exposed the cystic a clip or ligature is placed peripherally on the cystic duct. Through an incision in the duct central to the clip or ligature a cholangiogram catheter is introduced into the cystic duct and the cholangiogram is completed.
~After identification of the bile duct stones and anatomy, a cholangioscope is introduced through the duct incision into common bile duct. The stones are identified visually and removed by Dormia basket. If the stones are very large, they may be partitioned mechanically or by electrohydraulic lithotripsy. In the presence of CBDS wedged in the papilla these stones will be removed and a secondary cholangiogram will be performed. Subsequently, the cholangioscope is taken out. Then the cystic duct is divided and the gallbladder is dissected out from the liver by hook cautery and removed."
15757080|NCT04801238|Procedure|ERC + LC|Control intervention: (First step) Endoscopic retrograde cholangiography (ERC) is routinely performed in sedation but or in full anaesthesia. ERC is performed with the patient in the supine position. The endoscope is passed down to the second part of the duodenum where the papilla is identified. Cannulation of the papilla and the common bile duct is performed with a papillotome and a guidewire. A cholangiography will confirm the presence, location and size of the CBDS and aims in further choice of extraction method. Stones can be extracted by papillotomy and by either balloon or by a basket. Additional balloon dilation of the papilla, or lithotripsy may be required. If stone extraction is incomplete or if the conditions are unclear a temporary common bile duct stent is placed which has to be removed with additional ERC after 1-2 months (Second step) laparoscopic cholecystectomy is performed after 2-14 days
15757082|NCT04801212|Other|core stability exercises with teeth clenching|The intervention frequency will be 2 sessions per week for the duration of 6 weeks, comprising of 45 minutes session. Both groups will receive heat pack on lumbar spine for 12 minutes and both interventions will be held under the supervision of qualified Musculoskeletal Physiotherapists. During intervention and after 6 weeks of intervention.
15757083|NCT04801212|Other|core stability exercises|The intervention frequency will be 2 sessions per week for the duration of 6 weeks, comprising of 45 minutes session. Both groups will receive heat pack on lumbar spine for 12 minutes and both interventions will be held under the supervision of qualified Musculoskeletal Physiotherapists. During intervention and after 6 weeks of intervention.
15757084|NCT04801199|Drug|CPL-2009-0031 140 mg|Patients will receive OD CPL-2009-0031 140 mg for 36 weeks with or without breakfast with a glass of water.
15757085|NCT04801199|Drug|Sitagliptin 100mg|Patients will receive OD Sitagliptin 100 mg for 36 weeks with or without breakfast with a glass of water.
15757086|NCT04801173|Combination Product|Very low calorie ketogenic diet|Dietary intervention with a very low calorie ketogenic diet, using commercial products of the Pronokal PnK® method
15757087|NCT04801173|Behavioral|Low calorie standard diet|Low calorie standard diet with no specified dietary supplement addition
15757088|NCT04801160|Procedure|REMS+TAI|Radiation-Emitting Metallic Stents (REMS) Combined With Trans-Arterial Infusion (TAI) for Unresectable Hilar Cholangiocarcinoma
15757089|NCT04801160|Procedure|SEMS+TAI|Uncovered Self-Expandable Metallic Stent (SEMS) Combined With Trans-Arterial Infusion (TAI) for Unresectable Hilar Cholangiocarcinoma
15757090|NCT04801147|Biological|Dendritic Cells Vaccine|"Right after the surgical resection of the tumor, leukapheresis will be performed.
~At least 5x109 PBMC must be collected by leukapheresis, so as to make the whole immunotherapy schedule workable.
~Immunotherapy will follow radiochemotherapy and will comprise 4 vaccinations every second week (injections I, II, III, IV), 2 further monthly vaccinations (injections V, VI) and a final vaccination (injection VII) 2 months after the sixth one. Injections I, V, VI and VII will contain 10 million tumor lysate-loaded DC, while the others will be of 5 million cells only. In correspondence to the third vaccine injection (week 13), mTMZ will start.
~Vaccine doses will be injected in the forearm of the patient."
15757091|NCT04801134|Other|Education|as per previous description
15757092|NCT04801108|Procedure|VATS lobar fissure completion|The lobar fissure adjacent to the target lobe will be completed using a surgical stapler through video-assisted thoracic surgery.
15757093|NCT04801108|Device|Endobronchial valves placement|Endobronchial valves will be placed in the target lobe after the fissure completion.
15757094|NCT04801095|Drug|WM-S1-030|WM-S1-030 orally administered once daily (QD) for 28 days of each cycle.
15757095|NCT04801082|Drug|Alcohol injection|Chemical ablation is performed by injection of 10 mL of 0.25% bupivacaine, followed by 10 mL of 98% dehydrated alcohol using a 22G FNA needle (Cook and Olympus)
15757096|NCT04801082|Device|Radiofrequency Ablation|coeliac plexus is identified and punctured with 19G EUSRA RFA needle with 10W-30W of energy for 10-50s bilaterally or unilaterally depends on individual anatomical characteristics.
15757097|NCT04801069|Device|Nocturnal Ventilation|AirCurve 10CS PaceWave (Resmed)
15757098|NCT04801056|Drug|TB006|TB006 monoclonal antibody
15757099|NCT04801056|Other|Placebo|Placebo i.v. infusion
15757100|NCT04801043|Drug|XNW4107|XNW4107 250mg IV over 60 minutes as a single dose
15757101|NCT04801043|Drug|Imipenem/Cilastatin|500mg/500mg IV over 60 minutes as a single dose
15757102|NCT04801043|Drug|placebo|"Matching placebo to XNW4107 containing the same inactive ingredients IV over 60 minutes as a single dose
~Matching placebo to Imipenem/Cilastatin 0.9% sodium chloride IV over 60 minutes as a single dose"
15757103|NCT04801030|Behavioral|CoVax Facts|The intervention will be delivered via multiple strategies- social media (YouTube, Facebook), radio, newspaper, tv ads, community partner networks. Participants receive culturally-tailored message on COVID-19 and the vaccine. The strategies will have a link that will open to a website that is optimized for viewing on a computer or mobile phone which has the look and feel of an app, but without requiring the user to download anything to the phone. On the website, participants will be prompted to select their top concerns from a list. Based on the responses, the top barriers or need will each be mapped to a corresponding educational message, which will be displayed to the user with appropriate images or graphics.
15757104|NCT04801017|Drug|OT-101|TGF β2 specific synthetic 18 mer phosphorothioate antisense oligodeoxynucleotide
15757105|NCT04801017|Drug|Artemisinin|Herbal Supplement/ Purified extract from Artemisia
15757106|NCT04801017|Drug|Placebo|0.9% sodium chloride injection
15757108|NCT04800978|Biological|BAVC-C+Durvalumab|"Durvalumab Durvalumab will be supplied in glass vials containing 500 mg of liquid solution at a concentration of 50 mg/mL for infusion after dilution.
~BVAC-C BVAC-C will be supplied in cyclic olefin co-polymer vials containing 1x10⁸ cells of suspension at a concentration of 5x10⁷ cells/mL infusion"
15757109|NCT04800965|Behavioral|Patient MyChart Scheduling Link|Text message includes a link for patients to sign on to their patient portal (Epic MyChart) and schedule their COVID-19 vaccine appointment.
15757110|NCT04800965|Behavioral|Patient Educational Video|Text message includes a link to a patient education video that aims to encourage patients to obtain the COVID-19 vaccine.
15757111|NCT04800965|Behavioral|Enhanced Follow through Message|Text message includes information that will use enhanced language aimed at reducing psychological barriers that prevent patients from scheduling their appointment.
15757112|NCT04800952|Other|blood samples and filtered fluid will be collected.|"Arterial blood samples will be collected just before the commencement of continuous venovenous haemofiltration (CVVHF) and 1 h after the termination of CVVHF.
~Prefilter and post-filter venous blood samples and filtered fluid will be collected 1 and 3 h after the commencement of CVVHF and at the end of CVVHF."
15757145|NCT04800679|Drug|receive 4 monthly IVB injections and then rescue IVB|IVB group that receive 4 monthly IVB injections and then rescue IVB
15757146|NCT04800679|Drug|PRP group|PRP group that undergo full PRP in 2 or 3 sessions and then rescue IVB
15757147|NCT04800679|Drug|IVB injections and a modified laser|Combination group that receive 2 bimonthly IVB injections and a modified laser (1 session anterior to the equator) and then rescue IVB or laser
15757113|NCT04800939|Other|Acupressure|The experimental group will start with HT7 points and continue with SP6 points. The application will be carried out by determining the priority order of the points with the draw. Attention will be paid to the intensity and duration of the pressure deemed appropriate. Since the individuals' responses will differ, the stiffness and pressure will be adjusted according to the individual's sensitivity not to cause tissue damage. Before starting the application, around the area to be pressed for 20-30 seconds will be gently rubbed with palm. With the gentle rubbing of the surrounding tissue, the tension and tissue sensitivity in warming, relaxing and preparatory will be reduced, and the tissue will be relieved. After, the point determined will be pressed manually for 2 minutes.
15757114|NCT04800939|Other|Plasebo acupressure|In the control group, the application will start with the points 1.5 cm around the HT7 and SP6 points. The application process will continue in the same way with acupressure group and the pressure intensity will be less.
15757115|NCT04800926|Device|Xavier wheelchair controller|Controlling a wheelchair using the Xavier surface EMG system
15757116|NCT04800913|Diagnostic Test|Multimodal imaging|Preoperative 2D/3D TOE and MDCT, operative 2D/3D TOE and fluoroscopy/angiography, postoperative 2D/3D TOE and MDCT
15757117|NCT04800913|Diagnostic Test|Standard imaging|Preoperative 2D/3D TOE or MDCT, operative 2D/3D TOE and fluoroscopy/angiography, postoperative 2D/3D TOE and MDCT
15757118|NCT04800900|Other|Pharmaceutical intervention|A pharmacist will analyse patient's prescription, identify if there is prescribing omission and inappropriated drug prescribed and when necessary will require to doctors deprescribe or introduce or remove prescribed drugs
15757119|NCT04800887|Device|TECNIS Eyhance intraocular lens|Cataract surgery and implantation with extended depth of focus intraocular lens
15757120|NCT04800887|Device|Monofocal intraocular lens Tecnis ZCB00|Cataract surgery and implantation with monofocal intraocular lens
15757121|NCT04800874|Drug|BBP-418|BBP-418 is being developed for the treatment of patients with Limb-Girdle Muscular Dystrophy Type 2I (LGMD2I) for which no approved therapy currently exists. It targets the molecular defect at the source by supplying excess substrate to the mutant enzyme thus boosting glycosylation of muscle α-dystroglycan. The BBP-418 drug product will be packaged in sachets and provided in a carton for in-clinic and at home use.
15757122|NCT04800848|Device|Mask|Physical Fitness is evaluated with the use of a face mask
15757123|NCT04800835|Device|Gastric Balloon|implantation of two types of gastric balloons. Spatz3 Adjustable balloon will be implanted for 12 months and 6-month non adjustable balloon will be implanted for 6 months
15757124|NCT04800822|Drug|PF-07284892|PF-07284892
15757125|NCT04800822|Drug|lorlatinib|lorlatinib
15757126|NCT04800822|Drug|binimetinib|binimetinib
15757127|NCT04800822|Biological|cetuximab|cetuximab
15757128|NCT04800822|Drug|encorafenib|encorafenib
15757129|NCT04800809|Other|This study does not entail offering any intervention; all data collected will be based on standard of care.|This study does not entail offering any intervention; all data collected will be based on standard of care.
15757130|NCT04800796|Other|Audiovisual|Receive blended learning before and reading the Standard operating procedure
15757131|NCT04800783|Diagnostic Test|Swallowing ultrasound|Ultrasound assessment of the tongue movement and thickening, the geniohyoid and suprahyoid muscles echogenicity, thickness and thickening, the hyoid bone elevation, and the number of swallowing trial.
15757132|NCT04800770|Diagnostic Test|4C mortality score|4C mortality score and phosphate levels
15757133|NCT04800757|Behavioral|individual -Brief Motivational Intervention (BMI)|"A baseline survey will be administered prior to the session.Sessions will be initiated by exploring working conditions and psychosocial factors that may influence risk for work related injuries. If the LDL is motivated to change the target behavior, a 'change plan' will be developed which involves identifying reasons for change, goals in making change, specific actions and timelines, and others who may help the person change. The final step will be the development of a personal safety plan to reduce work place risks and a discussion of the following topics: (a) how they will know if their plan is successful, (b) potential obstacles, and (c) what the worker can do if the plan does not work. Finally,each worker will be asked to write and sign a personal pledge (Mi Promesa) to implement his own safety plan.Follow-up surveys will be conducted 4 weeks after the baseline survey."
15757134|NCT04800757|Behavioral|Group (Group Problem Solving)|Participant will be administered a baseline survey prior to the session.The group activity intervention will consist of a discussion between 3-4 LDL and a promotor (a peer LDL) trained as a group facilitator. The sessions are expected to last 20-30 minutes and are intended to provide an opportunity for the participants to work on a safety problem together, get to know each other, and enhance their mutual safety through mutual support.Follow-up surveys will be conducted 4 weeks after the baseline survey. Oral informed consent will be obtained prior to each follow-up survey. The follow-up surveys will reassess participants' work and injury experiences and experiences with the safety intervention they were provided - safety cards, change plan, or safety plan.
15757135|NCT04800757|Behavioral|Standard of Care (OSHA 10 Safety Cards)|Participant will be administered a baseline survey prior to the session.Participants in this standard of care control group will receive four wallet size cards with information about risk reduction strategies to deal with the four hazards responsible for most workplace fatalities in Texas: falls, struck by, heat exposure and cuts. The laminated cards are adapted from OSHA's website publicly available materials in Spanish for workers with limited literacy.
15757136|NCT04800744|Other|Lavender peppermint elequil aromatab|Lavender peppermint elequil aromatab applied pre-operatively and every 12 hours thereafter for the duration of the 72 hour treatment window.
15757137|NCT04800744|Other|Sweet almond oil elequil aromatab|Sweet almond oil elequil aromatab applied pre-operatively and every 12 hours thereafter for the duration of the 72 hour treatment window.
15757138|NCT04800731|Other|observation no intervention|no intervention
15757139|NCT04800718|Other|Intervention Arm|Intervention includes door-to-door screening and awareness generation in 8-12 villages surrounding the Vision Centres
15757140|NCT04800705|Other|ultrasound assessment|Zinc (Zn), copper (Cu), calcium (Ca), iron (Fe), manganese (Mn), selenium (Se), strontium (Sr), aluminum (Al), antimonium (Sb), phosphorus (P), magnesium (Mg), sodium (Na), potassium (K), barium (Ba) and thallium (Tl) measurements (µg/L,mean±SD)
15757148|NCT04800666|Procedure|Stellate Ganglion Block|Patients underwent a stellate-ganglion block at the anterolateral aspect of the C6 vertebra. After local analgesia (lidocaine 2%), a 22-gauge Quincke needle was placed in the anterolateral aspect of the C6 vertebral body. When the needle contacted the bone, it was drawn back 1 mm. 5 mL of 0·5% ropivacaine was subsequently injected next to the stellate ganglion to produce a sympathetic block.The effect of the stellate-ganglion block on the sympathetic nervous system was confirmed by the presence of Horner's syndrome (ie, facial anhydrosis, enophthalmos, ptosis, swelling of the lower eyelid, miosis, and blood-shot conjunctiva), and an increase in the temperature of the right hand of at least 2°F from baseline.
15757149|NCT04800666|Procedure|Facial Nerve Block|Operator touching the location of the mastoid, in the external auditory canal just below the front of the mastoid vertical needling.When touch the surface of the mastoid,adjust the needle across the front of the mastoid then slow needling about 1cm.The pin located below the stylomastoid foramen, and then injected drugs 5mL ( mecobalamin injection 1mg；lidocaine 60mg； dexamethasone 10mg )
15757150|NCT04800666|Drug|Mecobalamin Tablets|oral Mecobalamin Tablets tid-8
15757151|NCT04800653|Procedure|Stellate ganglion block|Find the position of the stellate ganglion under ultrasound guidance, and inject 0.375% ropivacaine near the stellate ganglion to block the sympathetic nerves in the upper chest and head and neck
15757152|NCT04800640|Other|Experimental: Electroanalgesia|The sample will consist of 66 individuals, of both men and women, where they will be randomly included in two groups: Intervention group composed of 33 patients who will effectively receive the treatment through electroanalgesia via TENS;
15757153|NCT04800627|Biological|Pembrolizumab|Given IV
15757154|NCT04800627|Drug|Pevonedistat|Given IV
15757155|NCT04800614|Drug|sitravatinib|100 mg sitravatinib on Day 1 of each of 3 periods
15757156|NCT04800601|Other|Rehabilitation program 1|"Both groups will benefit from a conventional rehabilitation treatment including a repetitive walking.
~In addition to this conventional rehabilitation, the experimental group will receive an ankle isokinetic program, 5 times a week, for 6 weeks (with a minimum of 25 sessions)"
15757157|NCT04800601|Other|Rehabilitation program 2|"Both groups will benefit from a conventional rehabilitation treatment including a repetitive walking.
~The control group will have a supplement in conventional rehabilitation equal to the additional time of the experimental group."
15757158|NCT04800588|Diagnostic Test|California Cognitive Assessment Battery|The California Cognitive Assessment Battery (CCAB) is a collection of computerized cognitive tests that will be telemedically administered to participants in their homes using a tablet computer and accessories provided by the research team. Testing may also occur in research laboratories. Previous versions of CCAB tests have been described in 16 manuscripts which describe (a) the psychometric characteristics of normative data collected in large participant populations (300 to 2,300 subjects for different tests) and (b) the sensitivity of CCAB tests for detecting performance abnormalities in patients with traumatic brain injury (TBI) and in control participants simulating the cognitive deficits that follow mild TBI.
15757159|NCT04800588|Diagnostic Test|Fast Automated Cognitive Test Battery|The Fast Automated Cognitive Test Battery (FACT-B) is a condensed selection of computerized cognitive tests drawn from the CCAB to act as a screening tool. These tests will be telemedically administered to participants in their homes using a tablet computer and accessories provided by the research team. Testing may also occur in research laboratories.
15757160|NCT04800575|Device|semi-permeable film|Experiment group use semi-permeable film as dressing in exit-site of CVC and dressings will be changed per hemodialysis session, or or whenever the dressing is soiled, bloody, or fell off.
15757161|NCT04800575|Device|sterile gauze and tape|Control group use sterile gauze and tape as dressing in exit-site of CVC and dressings will be changed per hemodialysis session, or whenever the dressing is soiled, bloody, or fell off.
15757162|NCT04800562|Drug|PCS499|PCS499 900mg twice a day with food
15757163|NCT04800562|Other|placebo|placebo comparator
15757164|NCT04800549|Other|Oral Mucositis|The data of the study were obtained by conducting six interviews with each child and the family. The first interview was conducted before starting to treatment on the first day of the treatment, the second interview was conducted on the 2nd day after the treatment and the following interviews were conducted on the 4th, 8th, 16th, and 21st days and in-mouth mucosa of the patient was evaluated by taking in-mouth pictures following interviewing with the child and the family. Oral care application was conducted four times a day with sodium bicarbonate solution and a lollipop made with black mulberry syrup (after meals and before going to the bed at night). Oral care was first conducted by the researcher, the oral care was then taught to the patient and patient's relatives and the application was evaluated. Figure 1 shows the study design.
15757165|NCT04800536|Other|Rapidly declining plasma glucose|Acute plasma glucose decline, divided into the following three phases: 1) Hyperglycaemic phase (plasma glucose 15 mmol/l), 2) Rapid plasma glucose decline phase and 3) Euglycaemic phase (plasma glucose 4.5-5.5 mmol/l).
15757166|NCT04800536|Other|Slowly declining plasma glucose|Acute plasma glucose decline, divided into the following three phases: 1) Hyperglycaemic phase (plasma glucose 15 mmol/l), 2) Slow plasma glucose decline phase and 3) Euglycaemic phase (plasma glucose 4.5-5.5 mmol/l).
15757168|NCT04800510|Device|Carbon Fiber Custom Dynamic Orthosis (CDO)|The CDO will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.
15757169|NCT04800497|Procedure|Hepatic resection|Hepatic resection for HCC
15757170|NCT04800484|Device|Tall Soft|Tall heel wedge made of soft foam
15757171|NCT04800484|Device|Tall Firm|Tall heel wedge made of firm foam
15757172|NCT04800484|Device|Short Soft|Short heel wedge made of soft foam
15757173|NCT04800484|Device|Short Firm|Short heel wedge made of firm foam
15757174|NCT04800471|Device|Smart insulin pens and CGM|Participants in this group will be monitored by Smart Insulin pens and Continuous Glucose Monitoring Devices
15757175|NCT04800471|Other|Point of Care Glucose Group|Participants in this group will be monitored by POC glucose values.
15757176|NCT04800458|Biological|Blood samples|If the platelet count is > 20 G / L : 50 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation If the platelet count is < 20 G / L : 30 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
15757177|NCT04800445|Diagnostic Test|Salivary CRP|Salivary C reactive protein in neonatal sepsis
15757178|NCT04800432|Behavioral|ADAPT+|ADAPT+ is designed as an 8-week intervention. For each session, children and parents participate in separate 1.5-hour group meetings, followed by a joint goal setting session. Practical strategies related to improving diet and physical activity as well as the role of dealing with parent stress-related factors related to making long-lasting behavioral changes in the family are addressed.
15757179|NCT04800432|Behavioral|EUC|Enhanced Usual Care is an abbreviated version of the full ADAPT+ intervention in which parents are engaged in a one-time, two hour information session to also learn knowledge and skills to improve the health and lifestyle behaviors for their child and for themselves.
15757180|NCT04800419|Behavioral|Acceptance and Commitment Therapy (ACT)|ACT is a third generation cognitive behavioral approach which uses acceptance and mindfulness processes, and commitment and behavior change processes to produce psychological flexibility. ACT increase adaptive coping through acceptance, cognitive defusion, mindfulness, and perspective-taking exercises while supporting cancer survivors in aligning behavior with their personal values. The objectives of the therapy are for client to learn to focus on behaviors and actions that are in line with their individual values - the things they care about most. ACT facilitates development and maintenance of health behavioral improvements by targeting internal barriers, such as emotional discomfort and self-defeating thoughts, and by fostering connection and commitment to personal values associated with self-management of positive health behaviors. ACT is useful in cancer patients, because it can help them to deal with the negative emotions caused by cancer instead of avoiding these.
15757181|NCT04800419|Behavioral|Mindfulness-based Stress Reduction (MBSR)|The term 'mindfulness' refers to mindful awareness as a way of being - a knowing and experiencing of feelings, thoughts, and perceptions as they arise and pass away each moment. It is a way of relating to all experiences in an open, receptive way, without judging experiences as good or bad (grasping at them or pushing them away). Mindfulness employed two styles of meditations: concentrative meditation involves intentionally focusing attention on a chosen object (e.g. the sensations of breathing) in a sustained way, while receptive meditation involves monitoring the content of experience (e.g. sensations, emotions, thoughts, sounds, etc.) in a non-reactive and non-judgmental way, from moment to moment, with the goal being to recognize the nature of emotional and cognitive patterns. Mindfulness-based stress reduction (MBSR) is an 8-week, standardized group intervention consisting of mindfulness meditation and gentle yoga that is designed to have applications for stress, pain, and illness
15757182|NCT04800406|Procedure|Dental Implants|Resorbable blast media surface treated dental implant and Acid etched surface treated dental implant.
15757183|NCT04800393|Drug|Sevoflurane|sevoflurane-based inhalational anesthesia during breast cancer surgery
15757184|NCT04800393|Drug|Propofol|propofol-based total intravenous anesthesia during breast cancer surgery
15757185|NCT04800380|Other|Edpuzzle interactive videos|The effectiveness of the Edpuzzle application will be evaluated in developing the metric and drug dose calculation skills of first year nursing students.
15757186|NCT04800367|Drug|Romosozumab Prefilled Syringe [Evenity]|2 syringes of 105 MG/1.17 mL subcutaneous solution injected one after the other, once a month from study baseline through 11 month visit
15757187|NCT04800367|Drug|Denosumab 60 MG/ML Prefilled Syringe [Prolia]|1 subcutaneous injection of 60 mg/mL every six months from study 12 month visit through the 24 month visit. Injections occur at the 12 and 18 month visits.
15757188|NCT04800354|Behavioral|Nurse-led Mindfulness Based Intervention|Nurses will read patients a brief (1 minute) scripted, introduction to mindfulness and then have them listen to a very brief (1 minute 30 second) guided mindfulness practice validated in our prior research to encourage focused attention on breath and body sensations and open monitoring and acceptance of discursive thoughts, negative emotions, and pain. Finally, patients will be given an audio recording of the mindful pain management technique for use any time they experience intense pain or take pain medication before and after surgery.
15757189|NCT04800354|Behavioral|Nurse-led Pain Psychoeducation|Nurses will provide psychoeducation about pain along with common pain coping strategies, such as rest, ice, and elevation, for use any time they experience intense pain or take pain medication before and after surgery.
15757190|NCT04800341|Other|Questionnaire|Structured questionnaire to collect cardiovascular and metabolic events, incident cancers and deaths that have occured, as weel as information on CPAP, through telephone interview.
15757191|NCT04800315|Drug|CC-93538|Subcutaneous once weekly
15757192|NCT04800315|Other|Placebo|Subcutaneous Every other week
15757193|NCT04800302|Procedure|Continous Quadratum Lumborum Block III|Continuous infusion of Bupivacaine 0.125 % at a rate of 0.1 ml/kg/hr (not exceeding 12 ml/hour), infused through a catheter inserted in the plane between quadratus lumborum & psoas major muscles with ultrasound guidance.
15757194|NCT04800302|Procedure|Single dose Quadratum Lumborum Block III|Single injection of a mixture solution of 20 ml Bupivacaine 0.5% + 10 ml Lidocaine 2%, injected through a needle inserted at the posterior aspect of the quadratus lumborum muscle between it and erector spinae muscle with ultrasound guidance.
15757195|NCT04800302|Procedure|Intra-venous Morphine|Intra-venous Morphine [0.1 mg/kg] as rescue analgesic shots when the Visual Analogue Score (VAS) for pain exceeds 4.
15757196|NCT04800289|Other|questionnaires|questionnaires about disease and satisfaction of patient
15757197|NCT04800276|Other|muscle strengthening targeted on ischemic areas|muscle strengthening targeted on ischemic areas
15757198|NCT04800276|Other|global muscle strenghtening|global muscle strenghtening
15757199|NCT04800263|Drug|SHR-1905|SHR-1905 will be injected subcutaneously
15757200|NCT04800263|Drug|Placebo|Placebo will be injected subcutaneously
15757201|NCT04800250|Procedure|Treatment of gingival recessions|Patients will have a surgery for their gingival recessions. They will be enrolled in the split mouth-study. They will have on one side mucogain matrix transplant, an on another side they will have the gold standard procedure
15757204|NCT04800224|Drug|Standardized Brazilian Green Propolis Extract|900mg/day of Standardized Brazilian Green Propolis Extract for 10 days.
15757205|NCT04800224|Drug|Placebo|900mg/day of Placebo for 10 days.
15757206|NCT04800211|Other|Experimental: Test Product 1|Subjects were instructed to completely replace their cigarettes with the Test Product 1 EVP (Nu Mark LLC, MarkTen® XL Bold CLASSIC)
15757207|NCT04800211|Other|Experimental: Test Product 2|Subjects were instructed to completely replace their cigarettes with the Test Product 2 EVP (Nu Mark LLC, MarkTen® XL Bold MENTHOL)
15757209|NCT04800185|Drug|Crisaborole 2% Top Oint|To analyze the skin microbiome of patients with atopic dermatitis before, during, and after treatment with crisaborole 2% ointment
15757210|NCT04800185|Genetic|Skin Microbiome Swabs|At the baseline visit the investigator will identify sites for swabbing the skin including one affected distinct crisaborole-treated AD lesion, and one untreated AD lesion. The lesions will both be sampled at baseline, 14 days into treatment, 28 days into treatment, 3 months into treatment, and 4 weeks after treatment completion. Photographs of each lesion will be taken for reference. Skin swabs will be obtained in a sterile fashion using a BD Culture SwabsTM EZ Collection and Transport System (or equivalent) and soaked with sterilized 0.15 M NaCl and 0.1% Tween-20. The samples will be frozen at -80 C, kept at this temperature, and stored until analysis may be completed.
15757211|NCT04800172|Drug|Roflumilast|administration of roflumilast 500 mcg tablet once daily for 3 months.
15757212|NCT04800172|Drug|placebo|administration of placebo tablet once daily for 3 months.
15757213|NCT04800159|Drug|THC Cannabis|Vaporization of cannabis
15757214|NCT04800159|Drug|CBD Cannabis|Vaporization of cannabis
15757215|NCT04800159|Drug|Placebo|Vaporization of placebo
15757216|NCT04800146|Procedure|Blood sample|Patients will be asked to provide blood samples at specified time points: before and after the SARS-CoV-2 vaccination
15757217|NCT04800133|Biological|Tozinameran|mRNA vaccine developed by BioNTech against COVID-19
15757218|NCT04800133|Biological|CoronaVac|Inactivated virus vaccine developed by SinoVac against COVID-19
15757219|NCT04800120|Other|Hyperbaric Oxygen Therapy|Delivery of 100% oxygen within a hyperbaric oxygen therapy chamber
15757220|NCT04800107|Biological|Curcumin-phosphatidylcholine|500 mg of curcumin-phosphatidylcholine combined with 250 mg of boswellia-phosphatidyl
15757221|NCT04800107|Biological|Placebo capsule|Placebo capsule
15757222|NCT04800094|Device|Investigational Liver Fat Quantification Software|All subjects enrolled in this study will undergo two abdominal ultrasound examinations using the investigational Liver Fat Quantification feature on the Philips EPIQ Ultrasound System. In addition, all subjects will also undergo one MRI-PDFF examination according to the clinical standard of care.
15757223|NCT04800081|Drug|Sacubitril/Valsartan|Patients will be randomized to receive once-daily treatment with 100-400 mg of Sacubitril/Valsartan.
15757224|NCT04800081|Drug|Valsartan|Patients will be randomized to receive once-daily treatment with 80-320 mg of Valsartan.
15757225|NCT04800068|Diagnostic Test|[Ga-68] PSMA-11 PET/CT|Imaging scan
15757226|NCT04800068|Diagnostic Test|[Ga-68] PSMA-11 PET/MR|Imaging scan
15757227|NCT04800055|Other|Attractive Targeted Sugar Bait|ATSBs will be installed on all structures of consenting households in intervention areas for six months according to instructions from the manufacturer. Monitoring assistants will be responsible for providing individual level household orientation for the ATSB and seeking informed consent. Prior to ATSB deployment, community sensitization activities will be conducted to prepare communities for the intervention and research activities. Where appropriate, local media may be used to disseminate messages to sensitize the community to the intervention and the research.
15757228|NCT04800042|Diagnostic Test|Diagnostic test|Blood iron status : ferritin and transferrin saturation factor
15757229|NCT04800029|Other|Telehealth in preventing suicide (TIPS)|The TIPS synchronous telehealth protocol will consist of (a) two-way televideo evaluation with enhanced suicide risk components, performed by a Masters-level evaluator from Community HealthLink, and (b) telephone consultation and, in some cases, televideo evaluation by a psychiatrist for patients the evaluator judges should be admitted. The primary evaluation will gather data form the ED providers, patient, and any other collateral sources available. The core of the evaluation itself will consist of Community HealthLink's existing standard adult emergency mental health evaluation, which is a semi-structured evaluation focused primarily on informing a disposition decision on whether to admit the patient to a psychiatric unit. The evaluators will use this same evaluation to guide the telehealth evaluation.
15757230|NCT04800029|Other|Modified ED-SAFE|"Half of the ED discharged patients with suicide risk will be invited to receive post-discharge telephone counseling originally developed during the Emergency Department Safety Assessment and Follow-up Evaluation (ED-SAFE) study. The participant will receive three coaching/counseling calls, clustered within three months of the index visit, with some flexibility to continue beyond that if desired. These coaching calls will still follow the original structure and content from ED-SAFE, with modifications guided by study investigators."
15757231|NCT04800029|Other|Treatment as Usual (TAU)|No study related intervention, just monitoring of current practices used to provide suicide-related care in the non-intervention EDs.
15757232|NCT04800016|Device|AcrySof IQ Vivity Extended Vision IOL|UV and blue-light filtering extended depth of focus foldable IOL intended to provide a full range of vision from distance to functional near.
15757233|NCT04800016|Procedure|Cataract surgery|Cataract extraction by phacoemulsification, followed by implantation of the AcrySof IQ Vivity Extended Vision IOL
15757234|NCT04800003|Diagnostic Test|Gonial angle and submandibular fossa depth measurements from CBCT images|CBCT images were obtained from dry human mandibles
15757235|NCT04799990|Drug|Risankizumab|Subcutaneous Injection
15757236|NCT04799990|Biological|Comparator 1|Subcutaneous or Intravenous Injection
15757237|NCT04799990|Drug|Comparator 2|Oral, Opthalmic, Subcutaneous or Intravenous Injection
15757238|NCT04799964|Device|Flow diverter(Ton-bridgeMT, China)|The device is a self-expanding vascular stent system, which consists of a stent and a delivery system. The stent is made of platinum core nickel-titanium alloy material. The delivery system is composed of a delivery guide wire and an introduction sheath. The stent and the delivery guide wire are pre-installed in the introduction sheath.
15757239|NCT04799964|Device|Tubridge(Microport, China)|Tubridge consists of a stent system and a microcatheter system. The stent system consists of a stent and a conveyor, the stent is self-expanding as well.
15757240|NCT04799951|Other|a survey questionnaire to find knowledge, attitude and practices in treatment of breast cancer.|an electronic webbased survey to assess knowledge, attitudes and practices amongst surgeons with regards to breast conservation surgery and mastectomy
15757241|NCT04799938|Behavioral|Exercise|180 minutes of moderate-intensity exercise per week
15757242|NCT04799925|Drug|Febuxostat|uric acid lowering agent. dose: 80 mg once daily. duration: for 6 months
15757243|NCT04799912|Procedure|Elective labor induction|Elective labor induction at 39 weeks of gestation
15757244|NCT04799899|Behavioral|Adapted MBCT|The adapted MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will be taught how to use evidence-based mindfulness skills to regulate distress and choose healthy behaviors, as well as learn about cardiac health.
15757245|NCT04799899|Behavioral|Cardiac Health Enhancement|The cardiac health enhancement control group will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will learn about depression and cardiac health.
15757246|NCT04799886|Other|Semi structured interview|Interviews are performed by one research group member and based on beforehand decided questions and sub-questions. The interview material is transcribed and analysed on a theme level.
15757247|NCT04799873|Drug|AAT( Alpha 1 Antitrypsin)|AAT administration based on clinical indication
15757248|NCT04799860|Behavioral|health promotive work-way|"Clinical intervention: The patient is asked to fill in a screening form with life-style related questions. The caregiver takes adequate measures according to the recommendations of the national guideline and the filled in screeing form. The caregiver documents the measures taken.
~Implementation intervention as described previously: using tailored strategies to support implementation of the gudieline-based recommendations"
15757249|NCT04799847|Drug|Catumaxomab|This study is conducted in 3 phases sequentially: dose escalation phase, dose expansion phase and dose extension phase. In the dose escalation phase, the preliminary safety and pharmacokinetic profile of catumaxomab by instillation, at 3 dose levels, in NMIBC patients are investigated.
15757250|NCT04799834|Other|Questionnaire administration,blood sampling and genetic analyses.|"Adults (≥18 years) living in Bergamo and in all the towns of its territory shall be invited to voluntarily complete a questionnaire, with their personal data and information on SARS-CoV-2 clinical history (swab test and serologic test results, clinical symptoms, treatments, hospital care) and other previous conditions. Subjects considered fit for the genetic study will be asked to report to the Daccò Clinical Center for an interview, during which the data entered in the questionnaire will be reviewed and implemented, the informed consent for participation in the genetic investigations will be collected and blood sampling will be carried out.
~Genetic: Exome sequencing and genotyping of host genome of individuals infected with SARS-CoV-2 and showing severe disease (cases), or infected with SARS-CoV-2 and showing mild disease or remaining asymptomatic, and in individuals without evidence of infection with SARS-CoV-2 (negative sierology)."
15757251|NCT04799821|Other|Control|Participants will be asked to refrain from walnut intake and to follow an isocaloric meal plan that complies with the recommendations of a healthy Mediterranean-style eating pattern.
15757252|NCT04799821|Other|Walnut intake|Participants will be asked to consume walnuts along with an isocaloric meal plan that complies with the recommendations of a healthy Mediterranean-style eating pattern.
15757253|NCT04799782|Drug|Mirtazapine|15 mg dose before bed-time
15757254|NCT04799782|Drug|Placebo|One placebo pill before bed-time
15757255|NCT04799769|Device|Percutaneous arterial closure device|Large hole percutaneous arterial closure device
15757256|NCT04799743|Drug|Resveratrol|Resveratrol has been used as a food supplement. Its antiviral properties have been well studied including its inhibitory effect against the coronavirus MERS-CoV. Our previous in vitro and in vivo studies found that the compound had other health benefits such as anti-fibrotic effect.The anti-fibrotic effect will add an extra benefit for resveratrol to fight against COVID-19 as lungs are the most affected organs by the coronavirus, which may result in prolonged fibrotic damage of the lungs even when a patient is recovered from the COVID-19 disease.
15757257|NCT04799743|Drug|Placebo capsules|The placebo consist of mainly starch and microcrystalline cellulose, the usage and dosage are the same as the investigational drug.
15757258|NCT04799717|Behavioral|Gaming session|Participants will be provided the option to play an online game with the clinican for the first half of the session through an online platform.
15757259|NCT04799704|Diagnostic Test|swabbing of conjunctiva|Each eye will be sampled with a single, sterile, nylon, flocked swab
15757260|NCT04799691|Procedure|Invasive ventilation strategy|Use of an invasive ventilatory support strategy
15757261|NCT04799691|Procedure|Non-invasive ventilation strategies|Use of non-invasive ventilatory support strategies
15757262|NCT04799678|Other|Recording voice samples|A maximum of 9 voice sample recording session will be carried out on their phones and take less than 2 minutes each
15757263|NCT04799665|Diagnostic Test|Breast CT|This is a cross-sectional clinical study to determine the feasibility of breast CT for breast density assessment and association of CT-derived density measures with metabolic syndrome in overweight/obese Mexican-origin women in Southern Arizona. There is no intervention.
15757264|NCT04799652|Other|Survey|Survey of 21 questions. The questions were divided into sections, evaluating demographics, COVID-19 test status and symptoms, the surgeon's opinion on the COVID-19 vaccination and their main concerns. The questionnaire was completed anonymously between 15/01/2021 and 24/01/2021, before the start of vaccination of health care professionals in a Belgian hospital.
15757265|NCT04799639|Drug|Sindilimab +paclitaxel+ cisplantin|standard dose paclitaxel + cisplantin + Sindilimab every 3 weeks for 3 cycles
15757266|NCT04799626|Drug|biapenem,meropenem,piperacillin and tazobactam,tigecycline|biapenem,meropenem,piperacillin and tazobactam,tigecycline extended infusion time or continuous infusion for 24 hours;Tigecycline changed standard does for treatment.
15757267|NCT04799613|Other|walking speed|walking speed (normal speed vs. fast speed). fast speed was 25% faster than normal speed
15757268|NCT04799613|Other|visual loading|visual loading (walking through narrow pathway using VR)
15757269|NCT04799613|Other|dual task|dual task (serial subtraction using VR)
15757270|NCT04799613|Other|best side reduction|best side reduction (split belt mode, the speed of best side was reduced by 25% compared to the other side)
15757271|NCT04799600|Other|BRESCİA-COVİD Respiratory Severity Scale|KDIGO acute renal failure score BRESCİA-COVID Respiratory Severity Score
15757272|NCT04799587|Other|Magnet at P6|Magnet applied at P6 and attached with adhesive tape. The P6 pressure point is 2 inches proximal to the flexor retinaculum, between the flexor carpi radialis and palmaras longus.
15757273|NCT04799587|Other|Magnet applied to arm not at P6 pressure point.|Magnet applied to arm not at P6 pressure point and affixed with adhesive tape.
15757314|NCT04799236|Drug|Group 1: Miltefosine|Miltefosine 50 mg pill will be administered po every 8 hours with food, during 28 days
15757932|NCT04793932|Drug|long-course chemotherapy|other two months of chemotherapy before surgery
15757274|NCT04799574|Other|music therapy activities|"Music therapy activity course design (Protocol):
~The researchers in this study are the leaders of the activities and the nurses who had completed training in music therapy courses and obtained a senior music activity leadership certificate and qualification, such as books and internship certificates. The course design uses the percussion music theory and Dalcroze and Orpff music pedagogy to plan activities, as follows:
~Each class in the music therapy activity course design has a fixed process. The 90-minute course includes 10-15 minutes of warm-up activities, 50-60 minutes of main activities, 10-15 minutes of recovery activities, and 10 minutes of rest for the elders in the middle. The content of the weekly main activities uses different music, musical instruments, props, or rhythms to lead the rhythm music activities."
15757275|NCT04799561|Behavioral|Multimodal Teleprehabilitation|"Exercise Prescription: patients will be instructed on how to perform aerobic exercise (5 times/week: minimum 30-minute/day) and resistance training (3 times/week: 2-3 sets of 6-8 exercises repeated 8-12 times) at home. Exercise counseling will be weekly, using the video-conferencing application (Zoom).
~Nutrition: nutritional status and dietary intake will initially be assessed by the nutritionist using zoom. All patients will receive daily whey protein supplements. Special precautions will be considered if patients have specific medical conditions.
~Psychosocial intervention: Patients will have access to 1.5 hours of mental relaxation and coping mechanisms session within the first week of enrolment, using Zoom.
~Smoking Cessation: Patients with smoking habits will meet with a respiratory specialist using Zoom, who will establish recommendations and contact the physician for the recommended smoking cessation protocol.
~More counseling sessions will be provided as needed."
15757276|NCT04799548|Drug|Transcatheter Arterial Chemoembolization|"Patients will sequentially receive one cycle TACE (3 weeks), one cycle SOX regimen (3 weeks), one cycle TACE (3 weeks) and one cycle SOX (3 weeks) regimen, a total of 12-week neoadjuvant therapy.
~TACE cycle: Day 1: trans-femorally performed with infusion of oxaliplatin (85 mg/m2) into tumor blood vessels. Then, Embosphere® Microspheres (300-500 μm) will be injected for embolism. Day 1-14: Oral Tegafur Gimeracil Oteracil Potassium Capsule 40-60 mg bid.
~SOX cycle: Day 1: Oxaliplatin 130mg/m2 intravenous. Day 1-14: Oral Tegafur gimeracil oteracil potassium capsule 40-60 mg bid."
15757277|NCT04799548|Drug|Tislelizumab|PD-1 antibody Tislelizumab will be administrated by 200mg, ivgtt, q3w throughout 12-week neoadjuvant treatment.
15757278|NCT04799535|Procedure|Ultrasound|Undergo breast ultrasound
15757279|NCT04799509|Procedure|VATS lobectomy|VATS lobectomy
15757280|NCT04799470|Device|Novel DBS stimulation patterns|Stimulation patterns
15757281|NCT04799457|Other|Suture technique|We wil apply additional sutures to classical caesarean procedure.
15757282|NCT04799431|Drug|Neoantigen Vaccine with Poly-ICLC adjuvant|"Neoantigen Vaccine with Poly-ICLC adjuvant will be administered on days 1, 8, 15 and 22. 2 to 5 subcutaneous injections will be administered in the upper thighs, arms and/or back.
~Drug: 0.3 mg per peptide vaccine + 0.5mg Poly-ICLC"
15757283|NCT04799431|Drug|Retifanlimab|500 mg will be administered as a 30 minute IV. Infusion (-5 min/+15min) on Day 1 of each 28 day cycle every 4 weeks.
15757284|NCT04799418|Device|Open Label Extension Study|This study will investigate the safety and efficacy of extended treatments for the management of symptoms related to PD.
15757285|NCT04799405|Device|tDCS|"Daily sessions (28 daily sessions): The device will be used to apply 30 minutes of tDCS to the participant with MDD's scalp in each of 28 daily sessions.
~Thereafter, participants with MDD will undergo a taper phase of an additional 9 sessions of tDCS applied in progressively decreasing frequency until day #60 of the study as follows:
~First taper phase: three 30 minutes tDCS sessions applied every other day;
~Second taper phase: three 30 minutes tDCS sessions applied one every third day;
~Third and final taper phase: three final 30 minutes tDCS sessions applied one every fourth day."
15757286|NCT04799392|Device|NOWDx COVID-19 Test|The investigational device is the NOWDx COVID-19 Test.
15757287|NCT04799379|Drug|microporous polysaccharide hemospheres (MPH) agent in rectal surgery|Use of microporous polysaccharide hemospheres (MPH) agent in patients after rectal surgery to avoid pelvic collections and the use of any drain
15757288|NCT04799353|Drug|Budigalimab|Subcutaneous (SC)
15757289|NCT04799353|Drug|Placebo|Subcutaneous (SC)
15757290|NCT04799353|Drug|Budigalimab|Intravenous (IV)
15757291|NCT04799353|Drug|Placebo|Intravenous (IV)
15757292|NCT04799340|Behavioral|cognitive training|training to improve encoding and recognition of faces
15757293|NCT04799327|Drug|SHR20004|SHR20004：low dose
15757294|NCT04799327|Drug|SHR20004|SHR20004: medium dose
15757295|NCT04799327|Drug|SHR20004|SHR20004: high dose
15757296|NCT04799327|Drug|placebo|Placebo
15757297|NCT04799314|Drug|PD-1 Inhibitor Tislelizumab maintenance therapy|PD-1 Inhibitor Tislelizumab maintenance therapy
15757301|NCT04799288|Drug|Teriflunomide|Teriflunomide 14mg will be administered orally as 1 tablet once daily during the 9-month treatment phase of the study.
15757309|NCT04799262|Drug|Tofacitinib 5 MG|Oral tofacitinib at the dose of 5mg twice a day was given for 24 weeks. Prednisone at the daily dose of 15 mg was tapered to 2.5 mg or less within 24 weeks and was adjusted if flare-ups occurred.
15757315|NCT04799236|Drug|Group 2: Pentavalent Antimony|will be administered by IV infusion diluted in 150 ml of DWD5% over 20 minutes
15757316|NCT04799236|Drug|Group 3: Liposomal amphotericin B|3 amps (150 mg) will be administered by IV infusion iver 2 hours every other day for a total of 15 doses.
15757317|NCT04799223|Other|Four-foods eating guidelines|To follow a healthy eating pattern and consume four (4) foods designed for the study (extra virgin olive oil with olive leaf extract, chickpea dish with spinach, vegetable cream dish, and olive fiber) and to follow a healthy eating pattern.
15757318|NCT04799223|Other|No designed-foods eating guidelines|To follow a healthy eating pattern. Their diet is not accompanied by the four newly designed foods of the other group.
15757319|NCT04799210|Device|Eximis CS (Contained Segmentation) System|Containment, segmentation and extraction of uterine tissue in pre-menopausal women undergoing laparoscopic hysterectomy or myomectomy for non-cancer indications.
15757320|NCT04799197|Behavioral|Kicking it with the Gurlz|The intervention is a multicomponent intervention, including a screening, groups, and individual sessions.
15757321|NCT04799184|Drug|Levobupivacaine 0.25% with epinephrine 5 ug/ml|"The block will be performed under ultrasound vision at T5 level, with the patient seated.
~Once the ultrasound image is achieved, a 100 mm, 20 G Stimuplex needle will be punctured and a solution of levobupivacaine 0.25% with epinephrine 5 ug / ml until completing a volume of 20 ml in fractional form."
15757322|NCT04799184|Drug|Levobupivacaine 0.25% without epinephrine 5 ug/ml|"The block will be performed under ultrasound vision at T5 level, with the patient seated.
~Once the ultrasound image is achieved, a 100 mm, 20 G Stimuplex needle will be punctured and a solution of levobupivacaine 0.25% without epinephrine 5 ug / ml until completing a volume of 20 ml in fractional form."
15757323|NCT04799171|Other|Isometric Contraction Exercise - Young Adults (Age group 18-39)|Subjects will be asked to lie supine on MRI table with the 31P surface coil placed over the right vastus lateralis, and straps to immobilize the leg. At the start of the scan session, the investigators will instruct the participant on the isometric contraction exercise and coach the participant through a demonstration. The average flexion repetition time is on the order of 1.5 s for a 30 s duration at maximum kick intensity.
15757324|NCT04799171|Other|Isometric Contraction Exercise - Middle Age Adults (Age group 40-59)|Subjects will be asked to lie supine on MRI table with the 31P surface coil placed over the right vastus lateralis, and straps to immobilize the leg. At the start of the scan session, the investigators will instruct the participant on the isometric contraction exercise and coach the participant through a demonstration. The average flexion repetition time is on the order of 1.5 s for a 30 s duration at maximum kick intensity.
15757325|NCT04799171|Other|Isometric Contraction Exercise - Old Adults (Age group >60)|Subjects will be asked to lie supine on MRI table with the 31P surface coil placed over the right vastus lateralis, and straps to immobilize the leg. At the start of the scan session, the investigators will instruct the participant on the isometric contraction exercise and coach the participant through a demonstration. The average flexion repetition time is on the order of 1.5 s for a 30 s duration at maximum kick intensity.
15757326|NCT04799158|Drug|Vonoprazan|Orally via capsules
15757327|NCT04799158|Drug|Placebo|Orally via capsules
15757328|NCT04799119|Behavioral|Do As I Do (DAID) dog training|Children and their family dog will participate in this dog training program.
15757329|NCT04799106|Behavioral|Community Based Strategies for Early Detection of Melanoma|"The main procedures of this study include educational sessions about melanoma and how to detect it at its earliest stages with the help of a community health worker, conducting a self-skin examination every three months, helping to perform a skin examination every three months for a family member or friend who would be selected as a partner, and completing short questionnaires at the beginning of the study, at month three during the study, and at completion of the study."
15757330|NCT04799093|Diagnostic Test|EyeBOX|Eye-Tracking based diagnostic
15757332|NCT04799054|Drug|TransCon TLR7/8 Agonist|TransCon TLR7/8 Agonist will be administered as an IT injection
15757333|NCT04799054|Drug|Pembrolizumab|Pembrolizumab will be administered IV
15757334|NCT04799041|Drug|GTX 2/3|There were 15 patients in this group. Each one received only one treatment.
15757335|NCT04799041|Drug|Placebo|There were 15 patients in this group. Each one received only one treatment.
15757336|NCT04799028|Other|Traditional cow's milk|Fortified cow's milk
15757337|NCT04799028|Other|Experimental milk|Milk with synbiotics and fat blend
15757338|NCT04799028|Other|Habitual diet|Habitual diet
15757339|NCT04799015|Drug|Dexamethasone|Dexamethasone 10mg IV
15757340|NCT04799015|Drug|Metoclopramide 10mg|Metoclopramide 10mg IV
15757341|NCT04799002|Drug|Topotecan|Topotecan intraocular injection for chemotherapy in retinoblastoma
15757342|NCT04799002|Drug|Melphalan|Melphalan intraocular injection for chemotherapy in retinoblastoma
15757345|NCT04798976|Drug|neoadjuvant/adjuvant therapy|chemotherapy/endocrine therapy/surgery/radiotherapy
15757346|NCT04798963|Procedure|On-clamp partial nephrectomy|Partial nephrectomy will performed with renal artery clamping (less than or equal to 25 minutes)
15757347|NCT04798963|Procedure|Off-clamp partial nephrectomy|Partial nephrectomy will performed without renal artery clamping
15757348|NCT04798937|Other|Motivational interviewing|a health education program based on motivational interviewing provided by a nurse
15757382|NCT04798651|Biological|cerebro-spinal fluid|1 ml of cerebro-spinal fluid
15757383|NCT04798638|Drug|TY-9591 Tablets under Fasted Condition - Arm1|Phase 1 (period 1) fasted from 10 hours prior to dosing with 80 mg TY-9591 tablet (p o, once) and 4 hours after dosing on day 1.
15757352|NCT04798911|Other|Phase 1 Observational Interviews|Qualitative interviews with patients with SS
15757353|NCT04798898|Device|RFA (radiofrequency ablation)|Preoperative RFA-induced partial necrosis of the liver metastasis
15757354|NCT04798885|Behavioral|GAIN 2.0|1) three structured group sessions of two hours duration performed jointly by a neuropsychologist, an occupational therapist and a physiotherapist. Relatives are also invited. 2) Up to five weekly semi-structured individual sessions of 30 min. duration with an allocated therapist
15757355|NCT04798872|Other|Web-based educational program|The mothers and fathers will be provided a website that consist of 6 session. at the end of the session, the lactation consultant will do video call to the mothers to discuss the questions from mothers and fathers. after delivery, telephone counseling will be conducted by lactation consultant to mothers at 2, 4, and 6. weeks postpartum
15757356|NCT04798859|Other|Family centered in-home rehabilitation|Goal-oriented individualized intervention targeting brain injury related areas noted as challenging by the child and family
15757357|NCT04798859|Other|Control|Usual follow-up in the municipality
15757358|NCT04798846|Procedure|dorsal plating|Spanning Plate inserted dorsally below tendons Spanning External Fixator by rods inserted in distal radius and metacarpals
15757359|NCT04798833|Device|Integrated Newborn Care Kit (iNCK)|"Contents of the integrated newborn care kit:
~Clean birth kit: sterile blade, clean plastic sheet, plastic gloves, hand soap, cord ties/clamp, maternity pad to absorb post-natal bleeding, 10 cotton balls for applying Chlorhexidine (CHX) to the umbilical stump.
~3x200 µg dissolvable tablets of misoprostol to be ingested prophylactically following delivery of the baby and before delivery of the placenta to prevent post-partum hemorrhage
~4% CHX solution (15 mL)
~Sunflower oil emollient (50 mL)
~Temperature monitoring strip or sticker
~Fleece blanket for the newborn
~Click to heat warmer
~Pictorial guide that illustrates how and when to use each kit component
~Handheld electronic scale with suspended cloth sling (the scale will not be included with the kit but rather one will be issued to each Lady Health Worker in the experimental arm)
~Other Names: Neonatal Care Kit"
15757360|NCT04798820|Other|Dietary education|Dietary education provided to gastrectomy patients by dietitian.
15757361|NCT04798807|Diagnostic Test|Nutritional screening|
15757362|NCT04798794|Other|ECMO for neonates|Neonates (<28 j) supported by ECMO for severe respiratory failure
15757363|NCT04798781|Drug|Telatinib|900mg by mouth twice daily until disease progression, intolerable toxicities, or withdrawal of consent
15757364|NCT04798781|Drug|Keytruda|200mg intravenous infusion every three weeks until disease progression, intolerable toxicities, or withdrawal of consent
15757365|NCT04798768|Device|mCRM Therapy System|Communication testing between S-ICD and LCP in 4 body postures as well as required electrical testing.
15757366|NCT04798755|Drug|Methotrexate|Inicial dose 15mg/week increasing up to 25 mg/week
15757367|NCT04798755|Drug|Adalimumab|At the Baselin visit adalimumab 80 mg subcutaneous loading dose followed a week later by 40 mg every-other-week starting at Week 1.
15757368|NCT04798755|Drug|Adalimumab+Methotrexate|"Adalimumab: at the Baseline visit 80 mg subcutaneous loading dose followed a week later by 40 mg every-other-week starting at Week 1.
~Methotrexate:Inicial dose 15mg/week increasing up to 25 mg/week"
15757369|NCT04798742|Procedure|Gluteus maximus transfer|Gait analysis study of 15 patients with gluteus medius disruption
15757370|NCT04798729|Device|Digital Occlusal Recording with T-Scan|Occlusal contact recordings of all the teeth were obtained digitally under conditions of maximum bite force and centric occlusion only with the T-Scan (T-Scan III, version 9.1, Tekscan Inc., South Boston, USA).
15757371|NCT04798729|Device|Digital Occlusal Recording with Cerec Omnicam|Occlusal contact recordings of all the teeth were obtained digitally under conditions of maximum bite force and centric occlusion only with the CEREC Omnicam™ (version 4.2, Sirona Dental Systems, New York, USA).
15757372|NCT04798716|Drug|MSC-exosomes delivered intravenously every other day on an escalating dose: (2:4:8)|Escalating dose 2 X 10^9, 4 X 10^9, 8 X 10^9/mL
15757373|NCT04798716|Drug|MSC-exosomes delivered intravenously every other day on an escalating dose (8:4:8)|Escalating dose 8 X 10^9, 4 X 10^9, 8 X 10^9 mL
15757374|NCT04798716|Drug|MSC-exosomes delivered intravenously every other day (8:8:8)|Dosed 8 X 10^9, 8 X 10^9, 8 X 10^9 mL
15757375|NCT04798703|Drug|ONCOFID-P-B™ (PACLITAXEL-HYALURONIC ACID)|12 weekly intravesical instillations of ONCOFID-P-B™ (intensive treatment phase) followed by maintenance phase of the study, during which ONCOFID-P-B™ is furtherly administered once a month for 12 months in patients who achieved a complete response (CR) after the 12 weekly instillations.
15757376|NCT04798677|Dietary Supplement|ABBC1 Immunoessential|Powder for dissolution in water, based on a yeast beta-glucan complex and a consortium of Saccharomyces cerevisiae rich in selenium and zinc + excipents. Lemon flavor
15757377|NCT04798677|Dietary Supplement|Placebo|Powder for dissolution in water, excipents. Lemon flavor
15757378|NCT04798664|Behavioral|Removal of Financial Barriers|Free access to nicotine replacement therapies and/or reimbursement for smoking cessation prescription medications
15757379|NCT04798664|Behavioral|Financial Incentives|Financial incentive plan of up to $600 for biochemically-confirmed, sustained abstinence for 6 months.
15757380|NCT04798664|Behavioral|Mobile Health Application|Episodic future thinking tool to overcome temporal discounting of future
15757381|NCT04798651|Biological|blood sample|28 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
15757384|NCT04798638|Drug|Osimertinib Mesylate Tablets under Fasted Condition - Arm1|Phase 1 (period 2) fasted from 10 hours prior to dosing with 80 mg Osimertinib Mesylate Tablets (p o, once) and 4 hours after dosing on day 1.
15757385|NCT04798638|Drug|TY-9591 Tablets after a High-fat Meal - Arm1|Phase 2 (period 3) allocated high-fat meal prior to dosing with 80 mg TY-9591 tablet (p o, once) and 4 hours after dosing on day 1.
15757386|NCT04798638|Drug|Osimertinib Mesylate Tablets under Fasted Condition - Arm2|Phase 1 (period 1) fasted from 10 hours prior to dosing with 80 mg Osimertinib Mesylate Tablets (p o, once) and 4 hours after dosing on day 1.
15757387|NCT04798638|Drug|TY-9591 Tablets under Fasted Condition - Arm2|Phase 1 (period 2) fasted from 10 hours prior to dosing with 80 mg TY-9591 tablet (p o, once) and 4 hours after dosing on day 1.
15757388|NCT04798638|Drug|TY-9591 Tablets after a High-fat Meal - Arm2|Phase 2 (period 3) allocated high-fat meal prior to dosing with 80 mg TY-9591 tablet (p o, once) and 4 hours after dosing on day 1.
15757389|NCT04798612|Drug|Pegasys|45 mikrograms of Pegasys. Two subcutanous doses will be administered with at least 7 days in between
15757390|NCT04798612|Drug|Saline|0.50 ml of Saline. Two subcutanous doses will be administered with at least 7 days in between
15757391|NCT04798599|Other|Telemonitoring and teleorientation|"Teleservice will be performed through a digital platform (Video for Health - V4H). The service will consist of: a) recognition of the condition identified in the pandemic period, including updates on medical history, current oral health condition, search for dental care in other units, need for referral, change of hygiene habits, b) realization of diet guidance, hygiene and other necessary habits, made from a situational recognition of such habits, c) targeting the needs presented, in which individualized counselling will be given seeking to meet the demand presented by that family nucleus. A dental form developed on the digital platform Google Forms will serve as a guide for the performance of the service and where the collected data will be formally recorded. The guidelines, although individualized for the needs of each child, will follow a pre-defined and standardized structure and based on the best evidence available in the subject."
15757392|NCT04798599|Other|Control Group - Waiting list|No intervention (at least, until the time frame for outcome assessment)
15757393|NCT04798586|Drug|Elranatamab (PF-06863135)|BCMA-CD3 bispecific antibody
15757394|NCT04798560|Procedure|Pancreaticoduodenectomy|Patients udergo pancreaticoduodenectomy for periampullary tumors. All of them are observed for developing POPF
15757395|NCT04798547|Procedure|Short Myotomy|Evaluation of short length myotomy
15757396|NCT04798547|Procedure|Standard Length Myotomy|Standard Length Myotomy
15757397|NCT04798534|Behavioral|Service decentralization facilitation intervention|The intervention CHW will participate in three 60-minute intervention weekly sessions. During the intervention, CHW will be provided with the knowledge and skills to serve their MMT patients. The intervention sessions will also focus on enhancing the current service decentralization workflow so that the CHW can work with both their peer providers and their patients more efficiently. Two-times booster sessions will be offered before the 3- and 6-month survey for continued skill building for problem-solving. In addition to the group sessions, the intervention arm CHW will be encouraged to use a specially designed online platform to review the current policy and scientific findings, review their patients' treatment status, communicate with other providers, and provide instant consulting to their MMT patients. The MMT patients in the intervention condition can use the online platform to communicate with their CHW and view education materials disseminated by their MMT providers or CHW.
15757398|NCT04798521|Other|Tele-HCV|Patients will be prescribed HCV medication treatment for 4 weeks at a time. The study pharmacist will check in with the participant by telephone or telemedicine visit at week 0, week 4, and end of treatment to 1) determine general medication tolerance, 2) assess quality of adherence and 3) dispense medications. Peers will assist participants in keeping telehealth appointments and navigating medication pick up or storage. HCV labs will be repeated at 12 weeks post end of treatment and results will be relayed to the participant in the SVR12 follow up visit with the research assistant, along with follow up surveys. Those successfully achieving SVR12 will be counseled on ongoing harm reduction methods. Those showing persistent HCV viremia at 12 weeks post treatment will be referred to community-based HCV treatment providers for treatment re-initiation.
15757399|NCT04798521|Other|Community Linkage to Care|Following study inclusion and enrollment, research staff will refer the participant to a local community health clinic to engage in hepatitis C care and seek treatment. Peers will assist patients to engage with local primary care and health plan resources and will receive an information sheet on optional clinics to attend and questions to ask their provider.
15757400|NCT04798508|Other|Evoked related potential - P3 paradigm|Evoked related potential are performed for each patient during listen to its own name uttered by i) a neutral voice ii) a smiling voice iii) a rough voice
15757401|NCT04798495|Other|Multimodal interdisciplinary rehabilitation programme (HAPPY)|A feasibility study using a single arm pre-test post-test design. The aim was to develop and to assess feasibility of the multimodal interdisciplinary rehabilitation programme HAPPY in patients with haematological cancers, undergoing NMA-HSCT. Furthermore, to report health related quality of life, Patient Activation Measurement, VO2max, muscle power, body-composition, days at hospital, return to work and survival. A 6-month multimodal interdisciplinary rehabilitation programme was tested. We used motivating interviewing technique, individual supervised physical exercise training, relaxation exercises, nutritional counselling and lessons for patients and relatives in small groups. To reach patients at home, the team phoned patients, who were also given tablets with access to the project's homepage and an interactive physical exercise programme. Feasibility parameters were acceptability, practicality, safety and programme adherence.
15757402|NCT04798482|Drug|Dexmedetomidine|Patients will undergo the usual anal manometry study, with no adjuvant medications, per routine practice currently in the gastrointestinal unit. Following completion of manometry, 0.5 mcg/kg DEX will be administered over 1 minute followed by an infusion of 0.15 mcg/kg/hr. Manometry measurements will be followed for 15 minutes in response to DEX.
15757403|NCT04798469|Drug|Testosterone cypionate|Weekly intramuscular administration at a dose of 125 mg
15757404|NCT04798469|Drug|Placebo|Weekly intramuscular administration of placebo
15757405|NCT04798456|Behavioral|Coma scales|CRS-R and GOSE
15757406|NCT04798456|Diagnostic Test|Imaging, electrophysiology, body signals, and brain stimulation|MRI, fMRI, EEG, TMS-EEG, Olfaction, Respiration, EKG
15757407|NCT04798456|Behavioral|Questionnaires|several questionnaires and an interview with the caregiver
15757408|NCT04798443|Procedure|subureteral endoscopic Injection of Dextranomer/Hyaluronic acid (Dexell)|The subureteral endoscopic injection was done under general anesthesia. the investigators used the subureteral injection technique (STING), as described by O'Donnell and Puri. The volume of Dexell was injected until ureteral orifice collapse in all patients. The needle was held for 30 s.
15757409|NCT04798443|Procedure|open ureteral reimplantation (Lich-Gregoir)|The juxtavesical ureter is dissected by open surgery and a submucosal groove is created extending laterally from the ureteral hiatus along the course of the ureter. The ureter is placed in the groove and the detrusor is closed over the ureter with ureteric stent fixation for 21 days. the surgical wound is closed in layers. Urethral catheter for bladder drainage for 3-5 days.
15757410|NCT04798430|Drug|lerodalcibep|PCSK9 inhibitor
15757411|NCT04798417|Dietary Supplement|Probiotic supplement|Use of a probiotic sachet
15757412|NCT04798417|Dietary Supplement|Prebiotic supplement|Prebiotic sachets
15757413|NCT04798417|Dietary Supplement|Maltodextrin|Placebo comparator
15757414|NCT04798404|Other|Multimodal exercise intervention|The intervention conducted was a progressive multicomponent training protocol. The training consisted on 2 collective sessions of 1h per week, during 10 weeks. Sessions involved functional exercises, muscular reinforcement performed at body-weight or with small materials (elastic bands or dumbbells), balance, and adapted sport and physical activities. Progression was based on an increase in workload (or in muscle strains). The workload was considered as the interaction of intensity and volume of exercise (set x repetitions). Intensity was based on effort tolerance, modulate by contraction regimen, velocity and load (elastic bands stiffness). Participants were encouraged to reproduce exercises at home when they were performed easily in supervised collective sessions.
15757415|NCT04798391|Drug|Dexamethasone|Steroids and analgesics
15757416|NCT04798378|Device|Neurosleeve|Myoelectric devices for restoration of independent arm function
15757417|NCT04798365|Behavioral|Intervention group|medical education and distribution of educations materials
15757418|NCT04798352|Other|6-minute walk test|6-minute walk test
15757419|NCT04798352|Other|WIQ functional questionnaire|WIQ functional questionnaire
15757420|NCT04798352|Other|quality of life questionnaires (EQ5D5L and SF-36)|quality of life questionnaires (EQ5D5L and SF-36)
15757421|NCT04798339|Drug|Canakinumab Injection|Participants will be treated at 1 of 2 dose levels of Canakinumab, beginning at 150 mg and increasing to 300 mg or the Maximum Tolerated Dose
15757422|NCT04798339|Drug|Darbepoetin Alfa|Participants will receive Darbepoetin alfa subcutaneously at a dose of 300mg on days 1 and 15 of each cycle
15757423|NCT04798326|Drug|MW032|Subjects would receive a single 120mg (1.7 mL) of MW032 through subcutaneous injection, on the first day of treatment.
15757424|NCT04798326|Drug|Xgeva®|Subjects would receive a single 120mg (1.7 mL) of Xgeva® through subcutaneous injection, on the first day of treatment.
15757425|NCT04798313|Drug|MW031|Subjects would receive a single 60mg (1 mL) of MW031 through subcutaneous injection, on the first day of treatment.
15757426|NCT04798313|Drug|Prolia®|Subjects would receive a single 60mg (1 mL) of Prolia® through subcutaneous injection, on the first day of treatment.
15757427|NCT04798300|Procedure|Newly Introduced Gradient Monolithic Zirconia|Fabrication of full-coverage crowns over posterior teeth using Newly Introduced Gradient Monolithic Zirconia to measure wear
15757428|NCT04798300|Procedure|Full Strength Monolithic Zirconia|Fabrication of full-coverage crowns over posterior teeth using Full Strength Monolithic Zirconia to measure wear
15757429|NCT04798287|Drug|Tofacitinib|First eligible prescription for treating rheumatoid arthritis (RA)
15757430|NCT04798287|Drug|TNF Inhibitor|First eligible prescription for treating rheumatoid arthritis (RA)
15757432|NCT04798261|Device|Indigo Aspiration System|Indigo Aspiration System
15757433|NCT04798248|Behavioral|Momentary Affect Regulation - Safer Sex Intervention (MARSSI)|MARSSI is an individual-level intervention that involves a one-hour manualized session with a sexual reproductive health (SRH) counselor, followed by one-month of daily use of a mobile health app and a final 20-minute booster session with the SRH counselor.
15757434|NCT04798248|Behavioral|Podcast Health Group|Participants assigned to the Podcast Health Group will listen to ~20 minute podcast episode put out by the Susan G. Komen Foundation about family history of breast cancer; the podcast does not include information related to the outcomes of interest for the study.
15757435|NCT04798235|Biological|TSHA-101|AAV9 viral vector containing HEXA and HEXB genes to be administered via Intrathecal injection
15757436|NCT04798222|Drug|Treatment A|Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin tablet in fasted condition.
15757437|NCT04798222|Drug|Treatment B|Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fasted condition.
15757438|NCT04798222|Drug|Treatment C|Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 1 in fed condition
15757439|NCT04798222|Drug|Treatment D|Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fasted condition.
15757440|NCT04798222|Drug|Treatment E|Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 2 in fed condition.
15757441|NCT04798222|Drug|Treatment F|Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 3 in fasted condition.
15757442|NCT04798222|Drug|Treatment G|Participants will receive oral AZD9977 Dose A capsule and 10 mg dapagliflozin capsule 4 in fasted condition.
15757443|NCT04798222|Drug|Treatment H|Participants will receive oral dose of dapagliflozin capsule in fasted condition.
15757444|NCT04798209|Drug|ACT-777991 (SAD)|ACT-777991 administered as hard capsules for oral use.
15757445|NCT04798209|Drug|ACT-777991 (MAD)|ACT-777991 administered as hard capsules for oral use, once daily.
15757446|NCT04798209|Drug|Placebo (SAD)|ACT-777991 matching placebo administered as hard capsules for oral use.
15757447|NCT04798209|Drug|Placebo (MAD)|Matching placebo administered as hard capsules for oral use, once daily.
15757448|NCT04798209|Drug|14C-ACT-777991 microtracer (SAD - Absolute Bioavailability)|Single dose of 14C-ACT-777991 microtracer, administered intravenously.
15757449|NCT04798209|Drug|Microtracer matching placebo (SAD - Absolute Bioavailability)|Single dose of 14C-ACT-777991 microtracer matching placebo, administered intravenously.
15757450|NCT04798209|Drug|14C-ACT-777991 microtracer (MAD - ADME)|Single dose of 14C-ACT-777991 microtracer, oral solution..
15757451|NCT04798209|Drug|Microtracer matching placebo (MAD - ADME)|Single dose of 14C-ACT-777991 microtracer matching placebo, oral solution.
15757452|NCT04798196|Behavioral|ElderTree on laptop (ET- LT)|"ElderTree (ET) is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health.
~ET is based on the extensively tested Comprehensive Health Enhancement Support System (CHESS). ET is a walled garden free of ads, with design features based on older users' feedback as well as best-practice principles such as uncluttered screens and large type. ET uses computers to deliver key elements of successful interventions: long duration, ongoing outreach, prompts, monitoring, cognitive reframing, action planning, problem solving, self-tailoring, and peer support. ET-LT arm will access ET on Laptop (ET- LT)"
15757453|NCT04798196|Behavioral|ElderTree on smart system (ET- SS)|"ElderTree (ET) is an existing intervention providing tools, motivation, and support on a computer platform to help older adults manage their health.
~ET is based on the extensively tested Comprehensive Health Enhancement Support System (CHESS). ET is a walled garden free of ads, with design features based on older users' feedback as well as best-practice principles such as uncluttered screens and large type. ET uses computers to deliver key elements of successful interventions: long duration, ongoing outreach, prompts, monitoring, cognitive reframing, action planning, problem solving, self-tailoring, and peer support.
~ElderTree on smart system (ET- SS) will use voice-activated smart speakers connected to the Internet. Because they are used by talking and listening rather than typing and reading, many barriers associated with laptop use can be avoided."
15757454|NCT04798196|Behavioral|Treatment as usual (TAU)|Treatment as usual (TAU)
15757455|NCT04798183|Diagnostic Test|3-dimensional scan|Facial 3-dimensional scan according to posture
15757456|NCT04798170|Other|Utrasound|Ultrasound examination
15757457|NCT04798157|Radiation|transcranial doppler|Transcranial Doppler ultrasonography will be done using the ultrasound machine by placing a transducer over the relatively thinner temporal and occipital bones in order to visualize and evaluate the velocities at the circle of Willis.
15757458|NCT04798144|Device|Distilled water irrigation kept at 2.5°C degree|The use of cold distilled water for final irrigation of root canal system during root canal treatment
15757459|NCT04798144|Device|Distilled water irrigation kept at room temperature|The use of distilled water kept at room temperature for final irrigation of root canal system during root canal treatment
15757460|NCT04798131|Other|Active neurofeedback procedure|Patients will perform 5 fMRI sessions. Four consecutive fMRI runs (1/ day) during which they will continuously receive visual feedback computed from the fMRI signal analyzed with the hallucinations decoder. Patients will be trained to maintain the brain state associated with the no-hallucination state using appropriate coping strategies. A 5th fMRI scan will be performed at 1 month post-treatment.
15757461|NCT04798131|Other|Sham neurofeedback procedure|Patients will perform 5 fMRI sessions. Four consecutive fMRI runs (1/ day) during which they will receive a random feedback and a 5th run at 1 month post-treatment.
15757462|NCT04798118|Procedure|toilet bronchoscope|Toilet bronchoscopy will be done by infuse normal saline or N-Acetylcysteine with a syringe, observing the flow of saline at the distal tip of the bronchoscope then suction intra bronchial visible secretions during the procedure and also suction of specific lobe guided by radiological finding in the patient A chest X-ray will be routinely performed prior and after the procedure, HRCT is mandatory when chest x-ray not clearly defining the collapse monitoring of heart rate, oxygen saturation, ventilator parameters, and arterial blood pressure will be done
15757463|NCT04798105|Behavioral|Effects of tDCS of dlPFC on Probabilistic Selection Task|Predictors of Probabilistic Selection Task Performance including anodal tDCS of dlPFC, eye blink rate, extraversion and impulsiveness
15757464|NCT04798092|Procedure|parathyroidectomy|surgical removal of parathyroid adenoma(s) with postoperative biological cure
15757465|NCT04798066|Biological|HB-adMSC's|Autologous adipose derived mesenchymal stem cells
15757466|NCT04798053|Behavioral|Questionnaire|14-item Perceived Stress Scale (PSS-14), 9-item Patient Health Questionnaire (PHQ-9 questionnaire), State Trait Inventory Anxiety questionnaire (STAI questionnaire), Post-traumatic Stress Disorder Checklist Scale (PCL-S questionnaire)
15757467|NCT04798053|Biological|blood sample and salivary sample|10 ml whole blood for Peripheral blood and 2 ml saliva sample. Only for 100 cases.
15757468|NCT04798040|Other|cold application|To reduce pain, cold application is applied around the drain before the drain is removed.
15757469|NCT04798040|Other|lavender oil inhalation|To reduce pain, lavender oil is inhaled prior to drain removal.
15757470|NCT04798027|Biological|SARS-CoV-2 mRNA vaccine formulation 1|Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection
15757471|NCT04798027|Biological|SARS-CoV-2 mRNA vaccine formulation 2|Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection
15757472|NCT04798027|Biological|SARS-CoV-2 mRNA vaccine formulation 3|Pharmaceutical form: Sterile suspension Route of administration: Intramuscular injection
15757473|NCT04798027|Biological|Placebo (0.9% normal saline)|Pharmaceutical form: Liquid Route of administration: Intramuscular injection
15757474|NCT04798001|Biological|Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 1, Single Dose, Intranasal Drops|Single intranasal dose on Day 1, by intranasal drops
15757475|NCT04798001|Biological|Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 2, Single Dose, Intranasal Drops|Single intranasal dose on Day 1, by intranasal drops
15757476|NCT04798001|Biological|Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Single Dose, Intranasal Drops|Single intranasal dose on Day 1, by intranasal drops
15757477|NCT04798001|Biological|Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Two Doses, Intranasal Drops|Intranasal dose on Day 1 by intranasal drops. Followed by a second, identical dose on Day 36 by intranasal drops
15757478|NCT04798001|Biological|Investigational vaccine against SARS-CoV-2 [MV-014-212] Dosage 3, Single Dose, Intranasal Spray|Single intranasal dose on Day 1, by intranasal spray
15757479|NCT04797988|Device|eon® FR 1064 nm device|The subject will be treatment area - flanks, will be treated with the eon device.
15757509|NCT04797767|Biological|Recombinant Granulocyte Colony-Stimulating Factor|Given subcutaneously
15757480|NCT04797975|Biological|KDS-1000|"Non-randomized part of study:
~At the beginning of each dose level (Cohort), 3 patients will receive KDS-1000. These initial patients will be enrolled in a staggered manner to ensure detection of any early safety signals.
~Randomized part of the study (Can start when there are no safety concerns in the non-randomized cohorts):
~Cohort 1: Low Dose, 2x10E8 cells/dose
~Cohort 2: High Dose, 1x10E9 cells/dose"
15757481|NCT04797975|Other|Placebo|0.9% Normal Saline
15757482|NCT04797962|Behavioral|Case management|dedicated case management to address social support needs
15757483|NCT04797949|Drug|Low-dose aspirin|Women will be prescribed 81 mg of aspirin to take daily during pregnancy.
15757484|NCT04797936|Drug|BNO 1030|Imupret 25 drops х 6 times per day for 14 days
15757485|NCT04797936|Other|Standard care|isolation mode symptomatic therapy as needed: antipyretic (paracetamol) saline solutions in the nose x 4 times a day -14 days
15757486|NCT04797923|Drug|1. Treatment: IP chemotherapy + Systemic chemotherapy|1. Treatment: IP chemotherapy + Systemic chemotherapy Day1 + Day 8: IP Paclitaxel 40 mg/m2 every 3 weeks Day1: IV Oxaliplatin 100 mg/m2 every 3 weeks Day 1~14: Capecitabine 1000 mg/m2 PO, BID every 3 weeks
15757487|NCT04797923|Procedure|2. Response evaluation after 4 cycles of IP + systemic chemotherapy|"2. Response evaluation after 4 cycles of IP + systemic chemotherapy
~Conversion surgery will be done following diagnostic laparoscopy after 4 cycles of IP + systemic chemotherapy. Additional 4 cycles of IP + systemic chemotherapy wille be done following surgery.
~If surgery is impossible after 4th cycle, four additional cycles of treatment will be done, and convertibility will be evaluated.
~IP chemotherapy should not exceed total of 8 cycles."
15757488|NCT04797897|Device|CORI|unicondylar knee arthroplasty (UKA) treated with CORI
15757489|NCT04797897|Device|Conventional|unicondylar knee arthroplasty (UKA) treated with conventional approach with conventional manual instrumentation
15757490|NCT04797884|Device|TheraBionic Device|Each treatment day consists of three courses of 60-minute treatments to be administered in the morning, at noon, and in the evening. Each 6-week treatment period will be considered a cycle of treatment. With the exception of the first 60-minute treatment, which will be delivered at one of the Comprehensive Cancer Centers, all other treatments will be self-administered at the patient's home.
15757491|NCT04797884|Device|Placebo Device|Each treatment day consists of three courses of 60-minute treatments to be administered in the morning, at noon, and in the evening. Each 6-week treatment period will be considered a cycle of treatment. With the exception of the first 60-minute treatment, which will be delivered at one of the Comprehensive Cancer Centers, all other treatments will be self-administered at the patient's home.
15757492|NCT04797871|Behavioral|Resistance training|Participants will complete a 2-days-a-week training routine: Resistance training (RT, 50-75% 1RM (one-repetition maximum), 4 sets, 8-12 repetitions, 4 exercises). The warn up include Light Intensity Continuous Training (8-10 min, 65-70% HRR). Progressions will be individualized and consistent with patient tolerance. Sessions will be supervised by Physiotherapists and Graduated in Sports Sciences.
15757493|NCT04797871|Behavioral|Standard care|This group will be allocated to standard care and therefore no supervised exercise regimen according to scientific guidelines for general physical activity and return to sport provided by the ACSM guidelines for Chronic Obstructive Pulmonary Disease and Cardiovascular Disease.
15757494|NCT04797858|Behavioral|COVID-19 self-test|5 COVID-19 self-test kits will be given to participants after they have been tested for COVID-19. Participants will be instructed to give test kits to others in their social networks who are symptomatic, exposed to COVID-19, or otherwise at high risk of COVID-19.
15757495|NCT04797858|Behavioral|COVID-19 test referral|5 test referral cards and text messages on how to obtain COVID-19 testing will be given to participants after they have been tested for COVID-19. These cards and text messages will have information on how to obtain free COVID-19 tests at local testing sites. Participants will be instructed to give out referral cards and text messages to others in their social networks to obtain testing.
15757496|NCT04797845|Other|teleconsultation|Patients will benefit from a quarterly teleconsultation to assess the study criteria through different questionnaires during 12 months.
15757497|NCT04797832|Drug|IV Sodium Ferric Gluconate Complex|125 mg of IV Iron per day to 3 to 5 days according to hospitalisation length.
15757498|NCT04797819|Diagnostic Test|Coronary plaque components|Coronary plaque components were detected by CCTA method
15757499|NCT04797806|Drug|Anlotinib|Anlotinib 12 mg once a day from day 1 to 14 of a 21-day cycle.
15757500|NCT04797806|Drug|Icotinib|Icotinib：125 mg/tablet，three times a day，fasting or serving with food. It should be continued until disease progression or intolerable toxicity or patients withdraw of consent.
15757501|NCT04797793|Drug|Adapalene Gel 0.1%|The study medication will be self-applied topically on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
15757502|NCT04797793|Drug|Placebo Control|The study medication will be self-applied topically on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
15757503|NCT04797793|Drug|Differin® Gel (Adapalene 0.1%, Galderma)|The study medication will be self-applied topically on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
15757504|NCT04797780|Drug|SY-1425 + Azacitidine|"SY-1425 will be administered at 6 mg twice per day (BID) (orally) each day on Days 8 through 28 of each 28-day treatment cycle (total daily dose of 12 mg).
~Azacitidine will be administered at 75 mg/m2 (intravenously or subcutaneously) each day on Days 1 through 7 of each 28-day treatment cycle. If dosing on Days 6 and 7 is not possible due to logistical limitations, these doses may be delayed to Days 8 and 9. SY-1425/placebo is permitted to overlap with azacitidine on Days 8 through 9 of this alternative schedule."
15757505|NCT04797780|Drug|SY-1425 Matched Placebo + Azacitidine|"SY-1425 matched placebo will be administered at twice per day (BID) (orally) each day on Days 8 through 28 of each 28-day treatment cycle.
~Azacitidine will be administered at 75 mg/m2 (intravenously or subcutaneously) each day on Days 1 through 7 of each 28-day treatment cycle. If dosing on Days 6 and 7 is not possible due to logistical limitations, these doses may be delayed to Days 8 and 9. SY-1425/placebo is permitted to overlap with azacitidine on Days 8 through 9 of this alternative schedule."
15757506|NCT04797767|Drug|Cladribine|Given IV
15757507|NCT04797767|Drug|Cytarabine|Given IV
15757508|NCT04797767|Drug|Mitoxantrone|Given IV
15757511|NCT04797741|Other|IDEA3 Intervention|Delivery of IDEA3 intervention, a 12-hour online sexual assault resistance intervention for college women.
15757512|NCT04797728|Drug|Elacestrant|Elacestrant continuously at 400 mg given orally (PO), once a day, in a continuous schedule (QD) for 4 weeks (+/- 2 days)
15757513|NCT04797715|Drug|AXS-05|AXS-05 tablets, taken twice daily
15757514|NCT04797715|Drug|Placebo|Placebo tablets, taken twice daily
15757515|NCT04797702|Combination Product|Glumetinib combined with Toripalimab|"Ib：All enrolled subjects received Glumetinib combined with Toripalimab on a 21-day cycle, starting with 200mg/ day continuous Glumetinib and 240mg/ 3 weeks Toripalimab.
~II：The SMC will determine the dose group for the Phase II study based on the safety and initial efficacy data of the Phase Ib subjects. Approximately 62 evaluable subjects will be enrolled in the study to receive the recommended dose of Glumetinib once daily and continuous treatment with Toripalimab 240mg every 3 weeks."
15757516|NCT04797689|Behavioral|Trauma Informed Yoga|One licensed yoga instructor, trained in trauma-informed yoga delivery, will lead the online sessions. Participants will be instructed to engage in the class from a mat or chair in their home or move between them as the class unfolds. The instructor will begin the class by introducing the week's theme (e.g. grounding and safety, non-attachment, imprints of the past and impacts on our reactions to COVID-19, connection to nature), followed by a breath practice (10 min), a yoga practice (50 min), a meditation practice (10 min), and closing words (10 min).
15757517|NCT04797689|Behavioral|Trauma Informed Psychotherapy|Two licensed counsellors (MSW-trained) will co-facilitate the online version of this program. Facilitators will begin the session by introducing the week's theme (e.g. setting goals while working from home, being mindful, health coping) (10 min), followed by a lecture and activity to integrate learning (e.g. large and small group discussion using Zoom break out rooms, journaling) (70 min), and closing words (10 min).
15757518|NCT04797676|Procedure|different methods of specimen acquisition|After informed consent, the investigators use two methods to obtain specimens for patients with pancreatic ductal adenocarcinoma, who needs eus-fnb for auxiliary diagnosis and had the opportunity of surgery. One method is EUS-FNB with wet suction technique, the other is surgery (including radical operation and cytoreductive surgery). Both methods are used on the same patient to remove deviations in results caused by tumor heterogeneity.
15757519|NCT04797663|Device|Nd-YAG laser|laser hair removal device
15757520|NCT04797663|Drug|TCA 20%|chemical peel
15757521|NCT04797650|Drug|CTP-543, 8 mg BID|8 mg twice-daily (BID)
15757522|NCT04797650|Drug|CTP-543, 12 mg BID|12 mg twice-daily (BID)
15757523|NCT04797650|Drug|Placebo, BID|Placebo, twice-daily (BID)
15757524|NCT04797637|Device|ABBy® Adjustable Panniculus Retractor for Wound Care|The ABBy (G-Squared Medical, Brentwood, TN) is an extended-wear panniculus retractor/tissue stabilizer that is intended for use postoperatively after abdominal procedure. It is placed directly onto patient skin, superior to a transverse incision, and is then used to elevate redundant tissues away from an incision or wound (https://www.gsquaredmedical.com/How-it-Works.html). The ABBy can be removed and replaced by patients and can be used for up to 10 days. This study aims to assess the effect of ABBy use on postoperative pain, pain medication requirement, and patient satisfaction, when used as a patient-positioning device in women following cesarean delivery.
15757525|NCT04797624|Procedure|Gastric cancer surgery|Appropriate gastric cancer surgery types for the convenient patients
15757526|NCT04797611|Device|Investigational treatment mode (stimulation pattern)|Participants will self-administer twice daily treatments of Non-Invasive Brainstem Modulations for the treatment of Non-Motor Symptoms in Parkinson Disease for the duration of 12 weeks.
15757527|NCT04797598|Other|Virtual reality group|This will receive Virtual reality sessions and both group will receive conventional physical therapy as base line treatment
15757528|NCT04797598|Other|Cyclic training group|This will receive cyclic training session. both group will receive conventional physical therapy as base line treatment
15757529|NCT04797585|Other|Laparoscopic supracervical hysterectomy|Laparoscopic supracervical hysterectomy
15757530|NCT04797585|Other|Vaginal hysterectomy|Vaginal hysterectomy
15757531|NCT04797572|Device|Free Margin Cusp Sizer|The free margin cusp sizer will be used during aortic valve repair and sparing procedures as a caliper to measure the aortic valve free margin length.
15757532|NCT04797559|Procedure|SZaMN Block|Suprazygomatic Maxillary Nerve (SZaMN) Blocks bilaterally near the temples of the patient
15757533|NCT04797546|Procedure|Adductor Canal Block|Continous peripheral nerve block
15757534|NCT04797546|Device|Morphine Patient Controlled Analgesia|Morphine Patient Controlled Analgesia Delivery System
15757535|NCT04797533|Device|The Body Information Management Systems (BIMS)|"The Body Information Management Systems (BIMS) are advanced biological sensors which monitor human behaviour, activity and basic vital signs. There is a combination of four separate ultra-sensitive weighing scales attached to each of the individual legs of a hospital bed measuring:
~Micro-changes in weight distribution
~Activity/sleep pattern
~In addition to the bed-based system, there will be a wrist worn wearable (Samsung fit gear) that will monitor participants when they are both in and out of bed. These are about the size of a small watch, light weight, water resistant, and will be worn 24/7 by participants. These measure:
~Movement and sleep
~Heart rate"
15757536|NCT04797520|Device|Eko CORE Stethoscope|Eko CORE stethoscope will be used as a visual and auditory means of confirming placement of ETT
15757537|NCT04797520|Device|Point of care ultrasound|"Point of care ultrasound will be used as a means of confirming placement of ETT. This is the gold standard used in standard of care"
15757538|NCT04797507|Drug|SHR-1210 plus Anlotinib|SHR-1210: a novel anti-PD-1 antibody Anlotinib: a multi-kinase inhibitor
15757539|NCT04797494|Device|acrylic removable appliance|"Hand-made, dental laboratory-manufactured, acrylic removable appliances were made on the mandible after intraoral impressions (Alginate, Cavex).
~Patients were asked to wear the RA for a period of 3 weeks prior to restorative treatment, for 24 h per day, except for when eating."
15757540|NCT04797481|Procedure|Exercise|Group A participants will be invited to attend up to 24 exercise sessions (2 sessions per week and a 3rd optional) and 2 virtual (online; a 3rd will be optional) HF workshops over 8 weeks. All sessions will be delivered via online platforms, with 1 facilitator supporting up to 8 participants simultaneously in each session.
15757783|NCT04795336|Drug|Melatonin 5 mg|Melatonin is a widely sold synthetic molecule in various forms including tablets, gummies and liquid. In the present study, the tablet version of the medication will be used at a dose of 5mg
15757541|NCT04797481|Procedure|Self-managed exercise|Group B participants will be provided with a self-care exercise programme. The exercise programme will be home-based with a mixture of online video calls and telephone support contacts, alternating once every other week. The video or telephone contacts will be mutually agreed by the patient and the facilitator at a mutually convenient time and will aim to support Group B participants, by offering advice and tracking progress. Patients will be provided with two exercise programmes: I) a chair-based exercise programme (DVD will be provided), and ii) a progressive walking training programme (a manual will be provided). Patients will be advised to exercise ≥3 times per week, starting from their own personal level and gradually building up over 8 weeks in session's duration, frequency of sessions per week, and walking pace.
15757542|NCT04797468|Drug|HLX23|administered IV.
15757543|NCT04797455|Behavioral|DBT-Based Parenting Intervention|The intervention will consist of 4 individual telehealth parent sessions, to be completed within one month after the teen discharges from the inpatient hospital or within one month of linkage to care whatever comes first . Sessions will be 60-90 minute in length and will be offered weekly. Therapists may see parents more than once a week if needed, as long as the total number of sessions does not exceed 4.
15757544|NCT04797455|Behavioral|Treatment as usual|No parenting intervention provided beyond standard practices on the adolescent psychiatric inpatient unit.
15757547|NCT04797429|Other|Peer Support Intervention via Instant Messaging Service Tool (IMS-Tool)|Peer Support via the IMS-tool increases diabetes self-management, improves self-efficiacy, adherence and glycaemic control
15757548|NCT04797429|Other|antidiabetic therapy according to the current guidelines|In contrast, the control group has to manage their diabetes mellitus type 2 with standard support and without online exchange.
15757549|NCT04797416|Device|FGM infiltration 1 hour group|The sensor is activated immediately after wearing (including the time between the sensor activation and the first blood glucose value stored，about 1 hour).
15757550|NCT04797416|Device|FGM infiltration 6-hour group|Reactivate the sensor 5 hours after wearing (including the time between the sensor activation and the first blood glucose value stored，about 1 hour).
15757551|NCT04797416|Device|FGM infiltration 12-hour group|Reactivate the sensor 11 hours after wearing (including the time between the sensor activation and the first blood glucose value stored，about 1 hour).
15757552|NCT04797403|Behavioral|Stepped-care protocol adapted from the SPRINT intensive-treatment algorithm|The core component of the intervention is protocol-based treatment using the SPRINT intensive BP management algorithm. Implementation strategies include dissemination of SPRINT study findings, team-based collaborative care and shared-decision making, blood pressure audit and feedback, home blood pressure monitoring, and health coaching.
15757553|NCT04797390|Device|Advanced Pneumatic Compression Device (APCD)|Once daily treatment with Flexitouch Plus.
15757554|NCT04797390|Other|Usual Care|Usual care consists of a two-phase CDT. Phase 1 includes consultation with a lymphedema therapist, patient education, MLD, compression garments or bandages, skin care techniques, and a program of exercises and postural recommendations. Phase 2 consists of ongoing self-care, where patients conduct a life-long program of disease management that mimics the program in phase 1.
15757555|NCT04797377|Biological|Autologous ovarian PRP injection|The same day, within 1 hour of sample preparation, PRP injection will be performed transvaginally under ultrasound guidance and under sedation anesthesia into both ovaries using 11.8 inch (30 cm) single lumen 21G needles. The ovaries will be reached using needle guide preventing vascular or other structures rupture. The needle will be advanced into the centre of the ovarian medula without rotation. The correct tip placement will be confirmed by ultrasound. The activated PRP will be slowly introduced during careful retraction of the needle across the previously traversed ovarian cortex. The final PRP volume will be deposited under the ovarian capsule and the needle exit the ovary. Approximately 0.5 ml of the PRP solution will be injected into each ovary. After the procedure, the patients will be taken to the recovery room and will be observed for 30 minutes and also be discharged home on the same day.
15757556|NCT04797364|Diagnostic Test|Pharmacogenetic Testing|Participants will donate a 2ml (teaspoon) sample of saliva. DNA extracted from the saliva sample will be used for genotyping. Genotyping results will be translated into an interpretative clinical report using evidence-based software (Sequence2Script) developed by our group and delivered to the treating physician for use in their clinical decision-making. The report will contain genotyping results, predicted phenotype, and evidence-based drug selection and dosing recommendations relevant to the child's current and future care
15757557|NCT04797351|Behavioral|Dialectical Behavior Therapy - Skills|Pre-treatment session + 12 sessions DBT Skills Group (only) intervention
15757558|NCT04797338|Drug|Synarel, 0.2 Mg/Inh Nasal Spray|Intranasal treatment with Nafarelin inhaler: 200 micrograms twice daily (a total of 400 micrograms/d; Synarel, Pfizer) on the evening after oocyte retrieval, which will be continued up to the bHCG blood test, 12 days post embryo transfer. In cases with positive serum bHCG results, the treatment will be stopped.
15757559|NCT04797338|Drug|Estrofem|A combination of oral estrogen (Estrofem or Progynova 4 mg twice daily), vaginal progesterone (vaginal Utrogestan 200mg or Endometrin 100 mg three times daily) and intramuscular injection of Hydroxyprogesterone Caproate 250 mg once every five days. The treatment will start at the day of the oocyte retrieval up to the bHCG blood test, 12 days post embryo transfer. In cases with positive serum bHCG results, the treatment will be continued up to 9+0 weeks of pregnancy.
15757560|NCT04797338|Drug|Utrogestan|A combination of oral estrogen (Estrofem or Progynova 4 mg twice daily), vaginal progesterone (vaginal Utrogestan 200mg or Endometrin 100 mg three times daily) and intramuscular injection of Hydroxyprogesterone Caproate 250 mg once every five days. The treatment will start at the day of the oocyte retrieval up to the bHCG blood test, 12 days post embryo transfer. In cases with positive serum bHCG results, the treatment will be continued up to 9+0 weeks of pregnancy.
15757784|NCT04795336|Other|Placebo|The placebo ingredients are Microcrystalline Cellulose, Silica, Gelatin, Titanium Dioxide, Red #3, and Blue #1.
15757785|NCT04795323|Device|Self-management support|Self-management support
15757561|NCT04797338|Drug|Hydroxyprogesterone Caproate|A combination of oral estrogen (Estrofem or Progynova 4 mg twice daily), vaginal progesterone (vaginal Utrogestan 200mg or Endometrin 100 mg three times daily) and intramuscular injection of Hydroxyprogesterone Caproate 250 mg once every five days. The treatment will start at the day of the oocyte retrieval up to the bHCG blood test, 12 days post embryo transfer. In cases with positive serum bHCG results, the treatment will be continued up to 9+0 weeks of pregnancy.
15757562|NCT04797325|Drug|Vedolizumab|Repeatedly vedolizumab infusion at week 0, 2, 6, 14, 22
15757563|NCT04797325|Drug|Prednisolone|tablet prednisolone plus infliximab in severe cases.
15757564|NCT04797312|Drug|Opioid Free Anaesthesia protocol|"The OFA protocol begins with a systematic preoperative premedication with clonidine, continues with an adapted intraoperative management without opioid administration, but associating several molecules (clonidine, magnesium, lidocaine, ketamine) and ends with a continued administration of xylocaine up to 1 hour postoperatively in PACU. The use of an opioid in preoperative or intraoperative phases is considered as a deviation from the protocol.
~To these different molecules, the use of hypnotic molecules left to the choice of the practitioner and a curare will be systematically associated."
15757565|NCT04797312|Drug|standard practice protocol based on the use of opioids (sufentanil or remifentanil)|Standard anesthetic practices can be summed up as the combination of a hypnotic, a morphinic (sufentanil or remifentanil) and a curare. The use of ketamine is allowed.
15757566|NCT04797286|Drug|Sildenafil|Sildenafil 20 mg three times a day. This is the approved dose for the treatment of pulmonary arterial hypertension. It is being studied in this trial with a population who has mildly elevated pulmonary pressures.
15757567|NCT04797286|Other|Placebo|Oral pill placebo.
15757568|NCT04797273|Behavioral|Internet-based cognitive behavior therapy|12 week Internet-based cognitive behavior therapy, delivered via an online treatment platform. The treatment includes components such as exercises in conducting recuperating activities, methods to improve sleep, exposure, and behavioral activation. The treatment content is provided through written texts, images and audiofiles in the treatment platform. The participant has access to a therapist who provides support throughout the treatment via asynchronous text messages.
15757569|NCT04797273|Behavioral|Internet-based structured treatment-as-usual|This is a 12-week treatment, delivered via an online treatment platform. The treatment components in this treatment are designed to be similar to what is typically provided in primary care to these patients and includes information about stress and how different factors such as eating habits, physical exercise, and alcohol can contribute to stress problems. The treatment content is provided through written texts, images and audiofiles in the treatment platform. The participant has access to a therapist who provides support throughout the treatment via asynchronous text messages.
15757570|NCT04797260|Genetic|Gene therapy|Patients will be infused with autologous CD34+ cells transduced with the pCCL.MND.coRAG1.wpre lentiviral vector (RAG1 LV CD34+ cells).
15757571|NCT04797247|Drug|lerodalcibep|PCSK9 inhibitor
15757572|NCT04797234|Other|Control|There will be no intervention to the control group.
15757573|NCT04797234|Other|Experiment|The experimental group will be trained for 6 weeks.
15757574|NCT04797208|Device|Real-Time CGM|Participants will be wearing a real-time continuous glucose sensor which will enable their glucose levels to be remotely monitored. High and Low glucose alerts will also be available.
15757575|NCT04797208|Device|Capillary blood glucose testing with masked CGM|Participants will have their glucose monitored in hospital in the conventional manner using the NovaStat® glucometer or similar CE-marked glucose meter) and insulin dose adjusted by the treating clinical team as per usual hospital guidelines. A masked subcutaneous CGM will be inserted for data collection only.
15757576|NCT04797195|Other|CKD-PD app with home monitoring equipment|use home monitoring equipment to measure blood pressure, body weight, and dialysate fluid volume and record in CKD-PD app
15757577|NCT04797182|Drug|avatrombopag|avatrombopag,60 mg/d,po
15757578|NCT04797169|Behavioral|Noom Health|In Noom Health, participants will be encouraged to use the Noom app multiple times a day to log eating episodes, physical activity and weight. They will also have the ability to interact with coaches to receive advice and feedback specific to weight loss.
15757579|NCT04797169|Behavioral|Noom Digital Health|In Noom Digital Health, participants will use a simplified version to log eating episodes and weight. Both conditions will receive the same weight loss advice content.
15757580|NCT04797156|Drug|High Dose Tranexamic acid|50mg/kg IV TXA
15757581|NCT04797156|Drug|Low Dose Tranexamic acid|20mg/kg IV TXA
15757582|NCT04797156|Drug|Tranexamic acid Topical|2g topical TXA
15757583|NCT04797156|Drug|Normal saline|Normal saline poured on wound
15757584|NCT04797143|Device|multidisciplinary consultation program|The multidisciplinary consultation program (MCP) was divided into 3 steps: the first step involved a consultation with an oncologist, the second step involved a consultation with an oncology pharmacist, and the third step involved a meeting with a coordinating nurse (CN). The CN put in place a regular telephone follow-up with the patient, a few days later (7 to 15 days), to ensure adherence and tolerance of the oral anticancer treatment (OAT).
15757585|NCT04797130|Device|Hospital Fit 2.0|HF consists of a smartphone app combined to an accelerometer. HF provides patients and physiotherapists direct feedback on patients' physical activity behavior.. Individual goals regarding the number of minutes per day spent walking can be set by the therapist. HF also shows patients insight into their own recovery progress. During every treatment, the physiotherapist will evaluate the extent of functional recovery. In addition, Hospital Fit will give physiotherapists the option of creating a patient-specific exercise program supported by videos. During every treatment session, the patient and physiotherapist will evaluate (and if necessary adapt) the amount of activity performed since the previous treatment, the extent of functional recovery and the exercise program.
15757586|NCT04797117|Diagnostic Test|blood sample|"The blood samples for the study for each patient will be collected in the form of additional tubes.
~either 1 tube of blood of 4 ml and 2 tubes of blood of 10 ml once a day for 1 or 2 days maximum (or 48 ml maximum) during his hospitalization
~either 2 tubes of 10 ml or 20 ml maximum once during his hospitalization."
15757587|NCT04797104|Drug|lerodalcibep|300 mg Q4W
15757640|NCT04796610|Behavioral|Mopati|The intervention will provide training to health care providers on how to guide unsuppressed HIV patients in the selection of treatment partners. The Mopati program will provide education to patients and their treatment partners about HIV treatment and how treatment partners can support patients in treatment adherence.
15757588|NCT04797091|Other|Retrospective data collection|Retrospective data collection to overcome the lack of knowledge on epidemiology, clinical course including diagnostic and therapeutic approaches and prognostic factors for SARS-CoV-2-infections and their complications among nephrology and elderly patients, as well as to serve as a platform for future studies and outbreak situations.
15757589|NCT04797078|Procedure|Transperineal biopsy|Transperineal free hand MRI-US fusion prostate biopsy
15757590|NCT04797078|Procedure|Transrectal biopsy|Transrectal MRI-US fusion prostate biopsy
15757591|NCT04797065|Procedure|6-minute then 9-minute withdrawal|"Patients in 6-minute then 9-minute withdrawal group will first be carefully observed in 6 minutes then in 9 minutes during the colonoscopy withdrawal.
~In actual performance, withdrawal of the right colon, transverse colon and the left colon can be operated in segmental tandem colonoscopy. Taking the right colon as an example, after the endoscope reaches the cecum, it can be withdrawn to the splenic curvature in 2 minutes, then reentered the cecum and withdrawn to the splenic curvature in 3 minutes."
15757592|NCT04797065|Procedure|9-minute then 6-minute withdrawal|"Patients in 9-minute then 6-minute withdrawal group will first be carefully observed in 9 minutes then in 6 minutes during the colonoscopy withdrawal.
~In actual performance, withdrawal of the right colon, transverse colon and the left colon can be operated in segmental tandem colonoscopy. Taking the right colon as an example, after the endoscope reaches the cecum, it can be withdrawn to the splenic curvature in 3 minutes, then reentered the cecum and withdrawn to the splenic curvature in 2 minutes."
15757593|NCT04797052|Device|Prefrontal EEG (VEEGix by NeuroServo)|Prefrontal EEG reading
15757594|NCT04797039|Procedure|MR guided cryoablation|MR guided cryoablation of focal biopsy proven prostate cancer
15757595|NCT04797026|Other|Letters to increase social connection with goal to alleviate loneliness|Our hypothesis is that a social program connecting patients in residential care facilities with high school students through monthly letter writing would positively impact quality of life for both, reducing quantitative and qualitiative measures of loneliness
15757596|NCT04797013|Drug|rt-PA|Subjects will be randomized to rhTNK-tPA or rt-PA in a 1:1 ratio.
15757597|NCT04797013|Drug|rhTNK-tPA|Subjects will be randomized to rhTNK-tPA or rt-PA in a 1:1 ratio.
15757598|NCT04797000|Drug|Eltrombopag|Eltrombopag comes in 12.5 mg & 25 mg tablets and is taken orally once per day (QD)
15757599|NCT04797000|Drug|Placebo|Placebo comes in 12.5 mg & 25 mg tablets and is taken orally once per day (QD)
15757600|NCT04796987|Diagnostic Test|Convolutional Neural Network|Convolutional neural networks, a machine learning technique, have been used in several industrial and research fields increasingly. The development of computational units and the increasing amount of data led to the development of new methods on artificial neural networks. Deep learning (DL) is a multi-layered neural network in which feature extraction is done automatically. It extends traditional neural networks by adding more hidden layers to the network architecture between the input and output layers to model more complex and nonlinear relationships.
15757601|NCT04796974|Device|Cention|Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the materials listed (Basic Filling Material). Procedures will be done using local anesthesia. The cavity is excavated and filled according to the guidelines for ordinary restorative techniques
15757602|NCT04796961|Other|Implementation Intervention|The implementation intervention involves training, coaching, expert consultation, organizational strategy meetings.
15757603|NCT04796948|Drug|Irinotecan liposome；oxaliplatin；5-FU(Fluorouracil Injection)；LV(Calcium Folinate Injection)|irinotecan liposome in combination with oxaliplatin and 5-FU/LV
15757604|NCT04796935|Device|Device Group 1: Tactile Imaging (VerTouch)|VerTouch device used to identify and mark, or begin placement of a needle at an insertion site. After the device is taken off the back, the procedure will continue in the usual manner for subjects in both groups.
15757605|NCT04796935|Other|Group 2: Control (palpation)|Control, palpation used to identify and mark an insertion site.
15757609|NCT04796909|Behavioral|Occupational Performance coaching|The OPC intervention comprises three components: (1) connect - building parents' trust in the coach by using verbal and nonverbal strategies; (2) structure - building parents' competence by adopting a problem-solving framework of setting goals, exploring options, planning action, carrying out plans, checking performance, and generalizing; and (3) share - building parents' autonomy by reciprocally exchanging information between the coach and parents with an emphasis on eliciting parents existing knowledge. During the exploration of the options for a particular goal, collaborative performance analysis is used. The coach follows the four steps to (a) identify parents' perception of what currently happens, (b) identify what they would like to happen, (c) explore barriers and bridges to the desired performance, and (d) identify their needs for taking actions to achieve goals. Parents are guided to find strategies to facilitate their child's performance to support goal achievement.
15757610|NCT04796909|Behavioral|Parent consultation|The parent consultation consists of the use of the toolbox to provide parents with available environmental resources and strategies to enhance community participation of their child with developmental disability, followed by the understanding of current situation and the identification of problems encountered by parents. Direct informing approach will be used to instruct parents about the availability of environmental resources close to their living areas and what they can plan to do by using possible supportive strategies. In addition, information about child disability and/or developmental milestone may be provided if needed.
15757611|NCT04796896|Biological|mRNA-1273|Sterile liquid for injection
15757612|NCT04796896|Biological|Placebo|0.9% sodium chloride (normal saline) injection
15757613|NCT04796883|Device|Hanita Glaucoma shunt Ver.3.2|The procedure will be performed under anesthesia (at physician discretion) and a Hanita shunt devce will be implanted.
15757641|NCT04796597|Device|Subcutaneous implantation of Epios sub-scalp leads|The sub-scalp Epios Leads will be implanted by a trained neurosurgeon and will provide epicranial EEG recording of specific cortical areas identified by the neurologist.
15757642|NCT04796584|Other|Analysis of cell-mediated and antibody-mediated immunity to SARS-CoV-2 virus|mRNA vaccination for SARS-CoV-2 is not provided by the study
15757615|NCT04796857|Drug|PD-1 Antibody|Tislelizumab will be administered every 4 weeks up to 6 cycles during induction phase if patients get CR or PR after induction phase.
15757616|NCT04796857|Drug|Lenalidomide|"Phase I: dose escalation phase. Patients will oral dosage as 10mg, 20mg, per day. Aim to evaluate MTD and DLT, RP2D.
~Phase II：Patients continuous oral lenalidomide as RP2D up to 6 cycles during induction phase"
15757617|NCT04796831|Drug|Quizartinib dihydrochloride|Single oral dose of 60 mg quizartinib (2 x 30 mg tablets)
15757618|NCT04796831|Drug|14C-Quizartinib solution for infusion|50 μg solution for infusion containing NMT 22.84 kBq 14C in 5 mL; administered once as a 15-minute infusion
15757619|NCT04796818|Procedure|Diffusion Weighted Imaging|Undergo IVIM DWI
15757620|NCT04796805|Other|Topical essential oil application|We applied black pepper essential oil to the participants in experimental group before the catheter insertion procedure
15757621|NCT04796792|Device|Break Wave Lithotripsy and Ultrasonic Propulsion|Novel ultrasound technologies to facilitate passage of stones.This includes Burst Wave Lithotripsy (BWL), a technology to noninvasively fragment urinary calculi within the kidney and ureter, and ultrasonic propulsion, a technology to non-invasively reposition stones within the kidney and ureter. BWL uses short multi-cycle bursts of low amplitude ultrasound to induce stone fracture. This is in contrast to traditional extracorporeal shock wave lithotripsy (SWL), which employs a brief single compression/tensile cycle of high amplitude (shock) waves to achieve stone fracture. Ultrasonic propulsion uses long multi-cycle bursts of low amplitude ultrasound to move stones within the collecting system.
15757622|NCT04796779|Device|Tandem t:slim X2 with Control-IQ Technology Pro|"The Tandem t:slim X2 with Control-IQ Technology Pro is an artificial pancreas (AP) application that uses advanced closed loop control algorithms to automatically manage blood glucose levels for people with Type 1 Diabetes. The system modulates insulin to keep blood glucose in a targeted range. The system components include the t:slim X2 with Control-IQ Technology and the Dexcom G6 CGM. The system is very similar to the commercially available t:sli X2 with Control-IQ but modified to accept the lower weight and Total Daily Insulin of the studied population."
15757623|NCT04796779|Device|Standard Care (SC)|Standard of Care consists in the participant existing insulin therapy (prior to enrollment) in conjunction with a study Dexcom G6 CGM. Existing insulin therapies are defined as multiple daily injections of insulin (MDI) or use of an insulin pump without hybrid closed-loop control capabilities (low-glucose suspend or predictive low-glucose suspend functionality is permitted).
15757624|NCT04796779|Device|Tandem t:slim X2 with Control-IQ Technology V1.5|"The Tandem t:slim X2 with Control-IQ Technology V1.5 is an artificial pancreas (AP) application that uses advanced closed loop control algorithms to automatically manage blood glucose levels for people with Type 1 Diabetes. The system modulates insulin to keep blood glucose in a targeted range. The system components include the t:slim X2 with Control-IQ Technology and the Dexcom G6 CGM. The system is derived from the commercially available t:slim X2 with Control-IQ, with additional features."
15757625|NCT04796766|Diagnostic Test|High frequency stimulation (HFS)|Electrical stimuli via circular electrode array. The electrode array serves as cathode placed above the eyebrow. A surface electrode (anode) will be placed on the temple. Electrical stimuli will be applied via a constant current stimulator. The stimulus intensity for the electrophysiological protocol is adjusted to the 10-fold of the detection threshold. A number of 5 electrical pulses (2 ms, 100 Hertz (Hz)), 10 second intervals.
15757626|NCT04796766|Diagnostic Test|Low-frequency sinusoidal transcutaneous stimulation (sLFS)|Stimulation of C-nociceptors with constant current stimulator. Electrodes (placed on the proband's forehead. Stimulation by sine wave pulses of 250 ms duration (4 Hz), intensities inducing a pain intensity of 50/100 on a visual analogue scale from 0-100.
15757627|NCT04796753|Other|Basketball Injury Defense|To establish a specific evaluation protocol for youth basketball players.
15757628|NCT04796714|Drug|Double antiplatelet therapy|One sachet of aspirin 160 mg and one tablet of clopidogrel 75 mg per day.during 3 months
15757629|NCT04796714|Drug|Aspirin|One sachet of aspirin 160 mg per day during 3 months
15757630|NCT04796714|Device|Brain MRI|Two cerebral Magnetic Resonance Imaging (MRI) examinations will be carried out (D0 and D90).
15757631|NCT04796714|Other|Neurological tests|Neurological assessment with the implementation of the modified rankin, National Institute of Health Stroke Score (NIHSS), and Montreal Cognitive Assessment (MoCA) tests (D1 and M3)
15757632|NCT04796701|Other|Follow-Home|x
15757633|NCT04796688|Drug|Fludarabine + Cyclophosphamide + CAR-NK-CD19 Cells|fludarabine 30 mg/kg on day -5, -4, and -3; cyclophosphamide 300 mg/kg on day -5, -4, and -3; CAR-NK-CD19 Cells on day 0.
15757634|NCT04796675|Drug|Fludarabine + Cyclophosphamide + CAR-NK-CD19 Cells|fludarabine 30 mg/kg on day -5, -4, and -3; cyclophosphamide 300 mg/kg on day -5, -4, and -3; CAR-NK-CD19 Cells on day 0.
15757635|NCT04796649|Device|B-Cure laser pro|The B-Cure laser Pro is a portal, non-invasive, low level laser therapy device, that emits light in the near infrared (808nm) over an area of 1X4.5 cm2 with power output of 250mW, and energy dose of 5J/min.
15757636|NCT04796649|Device|Sham|The sham device is externally identical to the B-Cure Pro and emit the same guiding light, but does not emit the therapeutic near infrared rays.
15757638|NCT04796623|Drug|TQB3616 capsules|TQB3616 capsules 180 mg given orally, once daily in 28-day cycle.
15757639|NCT04796623|Drug|Fulvestrant injection|Fulvestrant injection was given at a fixed dose of 500mg on day 1, day 15 of the first cycle and day 1 of each subsequent cycle, and each cycle is 28 days.
15757818|NCT04794933|Other|CT+ PNF in extremity pattern|
15757819|NCT04794933|Other|CT+ PNF in extremity pattern+PNF in scapula and upper trunk patterns|
15757933|NCT04793919|Drug|Mylotarg|See the protocol
15757643|NCT04796571|Behavioral|Proactive Symptom Monitoring and Care Coordination|Patients randomized to the intervention arm were assigned an IBD-focused care coordinator who facilitated a symptom-based monitoring algorithm and supported patient navigation to complement usual care. Symptom monitoring was facilitated through regular push notifications to participants to complete a validated PRO instrument through the Epic EMR patient portal or telephone. These notifications were scheduled on a monthly basis. The IBD-focused care coordinator made two attempts to reach each participant using portal messaging, followed by a phone call to reduce non-response. PRO questionnaires were reviewed by the care coordinator and out of range scores triggered algorithm-based recommendations to the IBD specialist including stricter monitoring of disease activity, behavioral and medication adherence counseling, facilitation of expedited follow-up with treating providers, and referrals to social work, mental health, and gastroenterology-specific behavioral health services.
15757644|NCT04796558|Other|AVAS Classification|Validation of AVAS classification
15757645|NCT04796545|Device|NG SI IMT 3X implant|The NG SI IMT 3X implant is a visual prosthetic implantable device, which, when combined with the optics of the cornea, constitutes a telephoto system for improvement of visual acuity in patients with bilateral, end-stage age-related macular degeneration.
15757646|NCT04796532|Other|Home based HIIT|"Intervention will consist in a 16-week exercise program with HIIT with a frequency of 3 days/week. The Home-HIIT group participants will attend HIIT workout sessions supervised by a specialised instructor via a videoconference application. Every HIIT workout session will have a 10 minutes' warm-up, followed by an 8/12/16/20 minutes of HIIT (stages of physical adaptation every 4 weeks) training and 5 minutes' cool-down. Tabata method will be used with eight sets of 20 seconds of exercise bouts separated by 10 seconds rest, in 2 to 5 blocks. The intervention will have four stages of physical adaptation.
~This group will have a follow-up period of 16 weeks."
15757647|NCT04796532|Other|Traditional HIIT|"Intervention will consist in a 16-week exercise program with HIIT with a frequency of 3 days/week. The Traditional HIIT group participants will attend a group HIIT workout sessions supervised by a specialised instructor in a sport facility. Every HIIT workout session will have a 10 minutes' warm-up, followed by an 8/12/16/20 minutes of HIIT (stages of physical adaptation every 4 weeks) training and 5 minutes' cool-down. Tabata method will be used with eight sets of 20 seconds of exercise bouts separated by 10 seconds rest, in 2 to 5 blocks. The intervention will have four stages of physical adaptation.
~This group will have a follow-up period of 16 weeks."
15757648|NCT04796519|Procedure|Total knee arthroplasty|Surgical procedure
15757649|NCT04796506|Other|Progressive Resistance Training (PRT)|PD subjects may be randomized (1:1) to PRT with supervised sessions 3 times per week for 12 weeks. Exercise training will consist of a combination of resistance training (RT) and bodyweight functional mobility exercises with limited rest intervals. The full volume exercise prescription will consist of: 1) five movements to improve strength and muscle mass each performed for 3 sets of 8-12 repetitions; 2) trunk exercises to improve postural stability; and 3) 3-4 bodyweight exercises to improve power and balance. Change in slow wave sleep (SWS) from baseline to 12-weeks will be used to determine the assignment in the second 12-week period. Subjects with an increase in SWS by >24 minutes will continue in PRT for the 2nd 12 weeks of the trial, while participants with <24 minutes increase in SWS will transition to endurance training (ET).
15757650|NCT04796506|Other|Delayed Exercise Training (DE)|PD subjects randomized to the exercise control group (1:1) will not exercise during the first 12 weeks of the study. During that time, they will be asked not to change their physical activity levels or dietary habits. All participants in the delayed-exercise group will begin PRT at completion of the 1st 12-week period.
15757651|NCT04796506|Other|Endurance Training (ET)|Non-responders to PRT will transition too ET during 2nd 12 weeks of the study. This intervention is supervised endurance training, 3 times per week for 12 weeks. Each session lasts approximately 75 min., comprised of warm-up, stimulus phase for 50-60 min., and cool-down. Sessions are split between cycle ergometer and treadmill exercise. Participant heart rate is monitored to maintain target exercise intensity of 60-80% (±5%) of heart rate reserve (HRR).
15757652|NCT04796480|Dietary Supplement|YOGURT|Group 1 was given yogurt
15757653|NCT04796480|Dietary Supplement|LACTOSE FREE FORMULA MILK|Group 2 was given lactose free formula milk
15757654|NCT04796467|Drug|68Ga-PSMA-617|Intravenous injection of one dosage of 148-185 MBq (4-5 mCi) 68Ga-PSMA-617. Tracer doses of 68Ga-PSMA-617 will be used to image lesions of prostate cancer by PET/CT.
15757655|NCT04796467|Drug|68Ga-P16-093|Intravenous injection of one dosage of 148-185 MBq (4-5 mCi) 68Ga-P16-093. Tracer doses of 68Ga-P16-093 will be used to image lesions of prostate cancer by PET/CT.
15757656|NCT04796454|Drug|Cisplatin|Cisplatin IV 25 mg/m² on d1 and d8 - always combined with Gemcitabine; maximum treatment 2 years
15757657|NCT04796454|Drug|Gemcitabine|Gemcitabine IV 1000 mg/m² on d1 and d8 if in combination with Cisplatin; Gemcitabine IV 1000 mg/m² on d1 and d15 if in combination with Oxaliplatin; maximum treatment 2 years
15757658|NCT04796454|Drug|Oxaliplatin|Oxaliplatin IV 100 mg/m² on d1 and d15 - always combined with Gemcitabine; maximum treatment 2 years
15757659|NCT04796454|Drug|Pamiparib|Pamiparib 60 mg PO twice a day from d1 to day28 in a 4-week cycle - always combined with Temozolomide; until progression or maximum treatment 2 years
15757660|NCT04796454|Drug|Temozolomide|Temozolomide 60 mg PO once a day from d1 to d7 in a 4-week cycle - always combined with Pamiparib; until progression or maximum treatment 2 years
15757661|NCT04796441|Biological|CAR-γδT|Biological: CAR-γδT; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;
15757662|NCT04796428|Drug|Canagliflozin|Canagliflozin If the patient is already on metformin, the fixed combination Canagliflozin / Metformin can be used.
15757663|NCT04796428|Drug|Dapagliflozin|"Dapagliflozin If the patient is already on metformin, the fixed combination dapagliflozin / metformin can be used.
~If the patient is already on a DPP-4 inhibitor, the fixed dose combination dapagliflozin / saxagliptin can be used."
15757664|NCT04796428|Drug|Empagliflozin|"If the patient is already on metformin, the fixed combination empagliflozin / metformin can be used.
~If the patient is already on a DPP-4 inhibitor, the fixed dose combination empagliflozin / linagliptin can be used."
15757696|NCT04796129|Other|the patients with hip osteoarthritis and their inflammatory status|The participants in the experimental group will be evaluated for the hip osteoarthritis. They will take and X-ray for hip joints and also hemogram for the excluding the inflammatory diseases.
15757820|NCT04794907|Other|Observation|Patient data will be collected from eye exams, surveys and medical record review.
15757665|NCT04796415|Behavioral|the DEMA-Pro intervention|Trained DEMA-Pro coaches will deliver six weekly, 1-hour telephone sessions. The first session is an orientation to the DEMA-Pro intervention and development of the initial Weekly Activity Plan based on the patient's self-identified meaningful activity. Over the next five weekly sessions, the coach uses problem-solving strategies to facilitate dyad collaboration to mutually identify meaningful activities and make a realist plan to achieve the patient-identified meaning activity goals. In each session, the patient and caregiver also select, review, and discuss one of six topics in the Self-Management Toolkit (e.g., planning meaningful activities; learning strategies for living with subjective cognitive impairment; finding resources, planning for the future).
15757666|NCT04796402|Biological|Bamlanivimab|700 mg/20mL IV over at least one hour OD
15757667|NCT04796402|Other|Standard of Care|Standard of care includes primary care and specialist care as indicated by the patient's primary care provider
15757668|NCT04796389|Other|Music|Preferred music of the participant administered using headphones.
15757669|NCT04796376|Procedure|combined partial fistulectomy or fistulotomy and cutting seton procedure|Partial excision of fistulous tract or just fistulotomy plus cutting seton procedure which is a rubber band or threads put through fistulous tract
15757670|NCT04796363|Procedure|Erector Spinae Plane Block with Bubivacaine|Erector Spinae Plane Block with Bubivacaine 0.25% or 0.125% before breast cancer surgery
15757671|NCT04796363|Procedure|Standard General Anaesthesia|Standard General Anaesthesia without ESPB
15757672|NCT04796350|Device|AGN1 LOEP treatment|the implantation site is injected with the AGN1 implant material
15757674|NCT04796324|Drug|Ixabepilone Injection|Ixabepilone 40 mg/m2 is administered as a 3-h intravenous infusion Day 1 in a 3-week cycle
15757675|NCT04796311|Diagnostic Test|blood samples|T cells, B cells and cytokines testing
15757676|NCT04796298|Procedure|Ballistic Hamstring Stretching|Athletes were asked to reach the floor in the BS group by leaning over in the standing posture without knee flexion. When they feel the tension in hamstring muscle groups, athletes were requested to make small rebounding motion at degrees between 3°-5° for half a minute.
15757677|NCT04796298|Procedure|Hamstring Extender Exercise|Athletes were asked to applied 12 repetitions and 3 sets of hamstring extender exercise. Firstly athlete lies on his/her back. Then, athlete is asked to do 90 degrees of knee and hip flexion at the same time. Finally, the person is expected to perform slow repetitive knee extension to the point of maximal possible extension.
15757678|NCT04796298|Procedure|Kinesiotape|Kinesio tape is applied on the hamstring muscle with a Y shape and %25 tension force.
15757679|NCT04796285|Device|Lab Clasp|Finger-based interstitial fluid assessment device
15757680|NCT04796272|Other|Adapted and individualized physical training program|Physical training program adapted and individualized according to each patient in this group
15757681|NCT04796272|Other|traditional training program|Same training program for all patients in this group
15757682|NCT04796259|Dietary Supplement|Malt ingredient|Solution with malt-derived ingredient
15757683|NCT04796259|Dietary Supplement|Non-alcoholic beer solids|Solution with non-alcoholic beer solids
15757684|NCT04796246|Other|Leap Motion Controller|Training with the Leap Motion Controller instrument will be carried out first for 5 minutes, for a presentation and interaction of the virtual immersion with it, in the initial meeting. After the second meeting, the attendance protocol will be 16 sessions, this time being distributed as: first game lasting 7 minutes, second and third games lasting 6 minutes each and the last game lasting 8 minutes, totaling 27 minutes of intervention. Between games it was adopted about 2 minutes of rest.
15757685|NCT04796246|Other|Conventional Physiotherapy|The conventional physiotherapy intervention will be based on the same activities developed (MMSS movements) of the IG: - First, attach pins with magnets with moving disc and after 1 minute and 25 seconds remove flower petals from inside a tube. The movements performed will be fine motricity, related to the tweezers handling (thumb and forefinger), alternating hands after 2 minutes and 30 minutes of play; - Hitting your hands on suddenly raised rulers, performing bilateral flexion / extension movements of the wrist simultaneously and alternating hands after 2 minutes and 30 minutes of play.
15757686|NCT04796220|Drug|Gemcitabine|Gemcitabine (900 mg/m2) will be administered intravenously on day 1.
15757687|NCT04796220|Device|Focused Ultrasound|Focused ultrasound will be applied to up to 2 breast lesions on day 8.
15757688|NCT04796220|Other|Gemcitabine and Focused Ultrasound|Gemcitabine (900 mg/m2) will be administered intravenously on day 1.Focused ultrasound will be applied to up to 2 breast lesions on day 8.
15757689|NCT04796207|Dietary Supplement|Fish Oil (DPA+EPA 2:1 ratio) Capsules|The Treatment Arm intervention consists of providing participants with 3 grams of DHA and EPA (2:1 weight ratio) in capsular form. In order to meet the required 3 grams of DHA and EPA, participants were given 6 capsules to be taken with meals (preferably breakfast, although capsules were provided at lunch when they couldn't be provided at breakfast). Capsules were given 3 times a week during the regular football season.
15757690|NCT04796207|Dietary Supplement|High Oleic Safflower Oil Capsules|"The Placebo Arm intervention consists of providing participants with 3 grams of high-oleic safflower oil in a 1:1 allocation ratio in capsular form. In order to maintain the study masking, participants in the Placebo Arm were given 6 capsules (the same as the Treatment Arm) to be taken with meals (preferably breakfast, although capsules were provided at lunch when they couldn't be provided at breakfast). Capsules were given 3 times a week during the regular football season."
15757691|NCT04796194|Combination Product|LTX-315 in combination with pembrolizumab|"Phase A Pembrolizumab will be given as 200 mg IV infusion over 30 minutes on Days 1 and 22.
~Phase B Pembrolizumab will be given as 400 mg IV infusion over 30 minutes every 6 weeks starting at Day 43 (3 weeks after the last dose of pembrolizumab in Phase A) until discontinuation from the study or for a maximum of 24 months' total therapy, whichever comes first."
15757692|NCT04796181|Device|Neteera 130H|The Neteera 130H will used to perform measurements in proximity to study participants.
15757693|NCT04796168|Procedure|Splinting (plaster of paris)|Placing stockinette followed by cotton rolls and 10-12 layer of posterior ankle splint made of plaster of paris
15757694|NCT04796155|Diagnostic Test|Intrapartum ultrasound|Intrapartum ultrasound will be performed by suprapubic and transperineal approach for 30 seconds.
15757695|NCT04796142|Other|medication reconciliation|medication reconciliation
15757934|NCT04793919|Drug|Arsenic Trioxide|See the protocol
15757699|NCT04796090|Other|Clinical assessment|FSFI, ASEX and FSDS scores were compared between the adolescents with (Study group) or without (Control group) genital warts.
15757700|NCT04796077|Other|Pop-Up Book|Patients spent 5-10 minutes reading an illustrated pop-up book that promoted active learning about the process of general anesthesia induction.
15757701|NCT04796064|Other|low-intensity aerobic training|"A low-intensity aerobic training group started with 15 minutes of warm-up, which includes static stretching of the upper and lower limb muscles. then participants were instructed to do 30 minutes of low-intensity aerobic training exercises, which include 20 minutes on the treadmill and 10 minutes of cycle ergometer, followed by 10 minutes of cool down.
~- In high-intensity training (HAT) the same protocol has been followed, but the intensity of exercises was fixed between 60% to 80 % of maximum heart rate. The strength training includes major group muscles such as shoulder flexors, extensors, and abductors, elbow flexors and extensors, hip flexors& extensors, knee flexors&extensors, abdominal and back muscles also were trained. Each group of muscles was trained for 10 repetitions for 3 sets with a rest period of 5 minutes."
15757702|NCT04796051|Device|Neck orthosis|The posterior cervical weight orthosis is made of a well-padded adjustable Velcro attached to the end with a two-kilogram weight attached with two durable straps. The device is firmly anchored around the curvature of the jaw and attached with Velcro to the apex of the skull.
15757703|NCT04796051|Other|Deep cervical flexors exercise|The participant will lay down in crook lying position, participant's head relaxed on the flat surface. Each participant will passively tuck in his/her chin without activation of superficial cervical muscles. Participants of this group will do 15 repetitions x 3 sets of deep neck flexor exercises every day of the week.
15757704|NCT04796038|Device|Balloon dilatation|Patient will be treated with balloon dilatation either stand-alone (POBA) or followed by stent implantation.
15757705|NCT04796025|Drug|Sintilimab; Bevacizumab Biosimilar|1-4 cycles, intra-arterial infusion: sindilimab 200mg + bevacizumab 7.5mg/kg, q3w; 5-18 cycles: Sintilimab (200mg ivdrip D1 Q3W)+Bevacizumab Biosimilar (15mg/kg ivdrip D1 Q3W）
15757706|NCT04796012|Drug|Atezolizumab|15 mg/kg (max 1,200 mg) IV on Day 1 of each 21-day cycle
15757707|NCT04796012|Drug|Vincristine|1.5 mg/m2 [max 2 mg] IV will be administered on Day 1 of each 21-day cycle
15757708|NCT04796012|Drug|Irinotecan|50 mg/m2 IV or 90 mg/m2 PO will be administered on Days 1-5 of each 21-day cycle
15757709|NCT04796012|Drug|Temozolomide|100 mg/m2 PO or IV will be administered on Days 1-5 if each 21-day cycle
15757710|NCT04795999|Behavioral|Project With|There are 12 lessons in Project With, typically delivered in six weekly sessions, with each session having two one-hour long lessons and a meal with facilitators in between the two lessons. Each lesson includes a discussion of selected literary works, including poetry, short stories, and excerpts from films and other videos. The curriculum is intended to be delivered to groups of 8-12 youth. In ideal program delivery, participants also share a meal with each other and with the Youth Advocate. Shared mealtimes create group cohesion and allow Youth Advocates to connect with participants on a personal level, building trust. At the end of the Project With curriculum, youth will partake in an offsite day excursion to Camp Eaton, a wooded camp outside of Los Angeles. At Camp Eaton, Youth Advocates will lead a Project With session, lunch, bonding activities and games, and an opportunity to engage in an outdoor activity.
15757711|NCT04795986|Procedure|HEARO Procedure|robotic access to the middle and inner ear in cochlear implantation
15757712|NCT04795973|Behavioral|intermittent fasting|intermittent fasting: choose two non-consecutive days per week to eat very little
15757713|NCT04795960|Dietary Supplement|Low serine diet|Participants will be on this diet 1 week prior to initiation and 1 week after initiation of Ustekinumab (standard of care medication). The meals will be prepared in the Michigan Clinical Research Unit (MCRU) at the University of Michigan Health System and given to the participants.
15757714|NCT04795960|Dietary Supplement|High serine diet|Participants will be on this diet 1 week prior to initiation and 1 week after initiation of Ustekinumab (standard of care medication). The meals will be prepared in the Michigan Clinical Research Unit (MCRU) at the University of Michigan Health System and given to the participants.
15757715|NCT04795947|Behavioral|Behavioral|There is no intervention in this study
15757716|NCT04795934|Procedure|LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION|LAPAROSCOPIC PARAESOPHAGEAL HIATAL HERNIA REPAIR COMBINED WITH TRANSORAL INCISIONLESS FUNDOPLICATION VERSUS LAPAROSCOPIC NISSEN FUNDOPLICATION
15757717|NCT04795908|Device|Transcranial Magnetic Stimulation|rTMS will be delivered using a MagStim Super Rapid2 TMS therapy system.
15757718|NCT04795908|Behavioral|Comprehensive behavioral intervention|Patients will receive CBIT with a therapist trained in CBIT. Each session will last about an hour and will be delivered remotely via telemedicine. Sessions will be tailed to the patient's individual needs.
15757719|NCT04795895|Diagnostic Test|ultrasonography (US)|US evaluation was performed after insertion of the tube via subxiphoid approach for tube passing esophagogastric (EG) junction. The tube insertion procedure will be repeated no more than three attempts if no visualization by US.
15757720|NCT04795895|Diagnostic Test|Standard routine (SR)|Standard routine (SR)
15757721|NCT04795882|Biological|BCMA CAR T cells|Infusion with ATIMP: BCMA CAR T-cells
15757722|NCT04795882|Biological|BCMA/CD19 CAR T cells|Infusion with ATIMP: BCMA/CD19 CAR T-cells
15757723|NCT04795869|Drug|Brentuximab Vedotin|Given IV
15757724|NCT04795869|Biological|Pembrolizumab|Given IV
15757821|NCT04794894|Behavioral|outpatient rehabilitation|Treatment provided after completion of inpatient, acute rehabilitation.
15757726|NCT04795843|Other|Progressive exercise therapy and patient education|Over a period of 6-month, patients will be offered eight individual physiotherapist-supervised training sessions. In these sessions, patients will be instructed in a home-based progressive exercise therapy programme and given patient education. The programme includes four exercises covering strength and stability training. The exercises will be performed in sets of three with a minimum of 5 repetitions, and patients will be instructed to perform a minimum of three training sessions each week. Each of the exercises can be progressed through three levels of difficulty levels, allowing for individualised treatment with regard to exercise quality and perceived exertion according to Borg CR10 scale. Exercises will be performed on a perceived exertion level from somewhat hard (level 5) to very hard (level 7). Patient education includes pain management, focus on exercise adherence and progression, and advice on physical activity.
15757727|NCT04795843|Other|Usual Care|Patients will follow usual care, including an individual consultation on self-management of hip symptoms and general advice on exercise and physical activity.
15757728|NCT04795830|Combination Product|Bioceramic root repair material as pulp dressing in pulpotomy in primary molars|BC RRM-F, a novel premixed bioceramic-based putty, can be used as a pulp dressing to promote pulp healing and repair with an added convenience for the pediatric patient. The aim of the present study is to evaluate the efficacy of a bioceramic root repair material as pulp dressing in pulpotomy in primary molars. The success of this material as pulpotomy dressing in primary molars will be evaluated clinically and radiographically in comparison to mineral trioxide aggregate pulpotomy. Both materials will be compared in terms of ease of handling, time to perform procedure and convenience of application. Each material's success will be evaluated by comparing its performance with or without the added peripheral seal of a stainless steel crown.
15757729|NCT04795830|Combination Product|Mineral Trioxide Aggregate as pulp dressing in primary molars (MTA)|MTA's sealing ability, biocompatibility, ability to stimulate hard tissue formation and its regenerative ability when used in contact with pulp tissues has made MTA pulpotomy the new gold standard as opposed to formocresol pulpotomy in treating the amputated pulp stumps of primary molars.
15757730|NCT04795817|Device|Transoral Robotic Surgery|Subjects will undergo TORS benign base of tongue resection procedures (i.e., partial glossectomy, epiglottoplasty, epiglottectomy, and/or lingual tonsillectomy) for the treatment of OSA. Concomitant non-robotic surgical procedures may also be performed as part of the subject's treatment for OSA, and can include one or more of the following: uvulopalatopharyngoplasty (UPPP), lateral pharyngoplasty, expansion sphincter pharyngoplasty, palatine tonsillectomy, or a modified uvulopalatoplasty. Nasal surgery such as septoplasty or turbinoplasty can be combined if it is needed.
15757731|NCT04795804|Dietary Supplement|Human Milk Oligossaccharide|The day before the CIDs, the participants receive the supplements 3x a day in randomized order
15757732|NCT04795804|Dietary Supplement|Maltodextrin|The day before the CIDs, the participants receive the supplements 3x a day in randomized order
15757733|NCT04795804|Dietary Supplement|Human Milk Oligossaccharide and resistant starch|The day before the CIDs, the participants receive the supplements 3x a day in randomized order
15757734|NCT04795765|Procedure|SpineJack system|For use in the reduction of painful osteoporotic vertebral compression fractures.
15757735|NCT04795765|Procedure|Balloon kyphoplasty|Treatment of osteoporotic vertebral compression fractures.
15757736|NCT04795765|Procedure|Vertebroplasty|Treatment of osteoporotic vertebral compression fractures.
15757737|NCT04795752|Device|TearCare System|TearCare procedures in this study will include an in-office eyelid debridement, 15 minute bilateral thermal session with the TearCare System, immediately followed by manual expression of the meibomian glands using the Clearance Assistant Plus device. Subjects randomized to TearCare will receive one in-office TearCare procedure within 7 days of the Baseline visit and at 5 Months. Beginning at 9 Months, subjects will receive an additional TearCare procedure when TBUT drops lower than Baseline or within 2 seconds of baseline AND/OR if OSDI worsens by at least 1 category.
15757738|NCT04795752|Drug|Restasis|Restasis group will be required to self-administer 1 drop twice a day from baseline through the Month 6 visit. At Month 6, subjects will be crossed over to the TearCare group and will receive one (1) TearCare procedure.
15757739|NCT04795726|Drug|Finerenone (BAY94-8862)|10 mg or 20 mg Finerenone tablet to be given orally, once daily, administered in the FIDELIO-DKD or FIGARO-DKD clinical trial.
15757740|NCT04795726|Drug|Placebo|Matching placebo to be taken orally, once daily, administered in the FIDELIO-DKD or FIGARO-DKD clinical trial.
15757741|NCT04795713|Drug|MT-6402|Experimental Treatment
15757742|NCT04795700|Behavioral|MSC intervention|Patients in the intervention group had access to conventional care, in addition to receiving the 8 weeks MSC intervention sessions. The intervention was provided by trained nurses, including one researcher and one MSC therapist. The intervention is mainly out-of-hospital intervention, supplemented by short-term in-hospital intervention. Among them, the first and second weeks of the intervention project in the hospital phase focus on guiding the research subjects to understand the content of mindful self-compassion and emotions, and carry out basic mindful self-compassion training; the content of the 3-8th week of the intervention program outside the hospital, Focus on the maintenance of mindful self-compassion training and the promotion of mindful life. Each face-to-face group contact lasted about 1 hour, depending on the complexity of the patients' problems.
15757743|NCT04795674|Behavioral|EWM Training|Training tasks will target Executive Working Memory areas of the brain. Task difficulty will be adaptively increased across the 5 weeks of training based on session-to-session performance.
15757744|NCT04795674|Behavioral|Placebo Training|Hoyle's tile games
15757745|NCT04795661|Drug|Pembrolizumab|Administered intravenous (IV)
15757746|NCT04795648|Device|Transfluthrin|Passive emanator with formulated transfluthrin
15757747|NCT04795648|Device|Placebo|Passive emanator with formulated inert ingredients
15757748|NCT04795635|Device|CMM + Axon Therapy|transcutaneous magnetic stimulation (tMS)
15757782|NCT04795349|Procedure|Vacuum-assisted breast biopsy|In those patients with a radiological complete response by all the radiological imaging methods, a stereotactic biopsy will be performed before surgery. After that, a comparison will be done between the results of the pre surgical biopsy and the definitive pathology of the specimen.
15757751|NCT04795609|Other|Early mobilization strategy adapted after immediate internal pudendal artery perforator flap reconstruction for abdominoperineal resection (intervention group).|"Early mobilization strategy adapted after immediate internal pudendal artery perforator flap reconstruction for abdominoperineal resection (intervention group).
~Trunk control.
~Orthostatism.
~Walk training.
~Aerobic exercises.
~Muscle strengthening."
15757752|NCT04795596|Procedure|secondary cytoreductive surgery|resection of isolated recurrent ovarian carcinoma in platinum resistant disease
15757753|NCT04795596|Drug|Chemotherapy|second line chemotherapy according to investigator's choice
15757754|NCT04795583|Drug|Prednisone|Prednisone 25 mg capsules
15757755|NCT04795583|Device|Point of Care testing device for C-reactive protein|Determination of C-reactive protein blood levels by point of care testing device
15757756|NCT04795570|Procedure|Transurethral resection of the prostate or bladder|All patients undergoing TUR P/B will undergo a blood draw within 6 months after surgery to determine hormonal status and coagulation disorders.
15757757|NCT04795557|Dietary Supplement|ADAPT-232 oral solution|"One ml of ADAPT 232/CHISAN oral solution contains:
~Fructus Schizandrae native extract DERnative 2-4:1, (extraction solvent . 95% ethanol) - 10 mg corresponding to 20-40 mg dried fruit; Radix Eleutherococci native extract DERnative 17-30:1 (extraction solvent - 70% ethanol) - 2.6 mg corresponding to 44-78 mg dried rhizomes, and Radix Rhodiolae native extract DERnative 2-5:1 (extraction solvent - 70% ethanol) - 3 mg corresponding to 6-30 mg dried rhizomes.
~Excipients"
15757758|NCT04795557|Other|Placebo oral solution|Excipients
15757759|NCT04795544|Procedure|Intracuff pressure measurement|Intracuff pressure is measured by a pressure manometer.
15757760|NCT04795531|Drug|Insulin icodec|"You will get a pen for weekly injection and one for daily injection. One will be icodec 700 units/mL and the other will be placebo.
~Subcutaneously (under the skin) injections"
15757761|NCT04795531|Drug|Placebo insulin icodec|"You will get a pen for weekly injection and one for daily injection. One will be insulin degludec 100 units/mL and the other will be placebo.
~Subcutaneously (under the skin) injections"
15757762|NCT04795531|Drug|Insulin degludec|"You will get a pen for weekly injection and one for daily injection. One will be degludec 100 units/mL and the other will be placebo.
~Subcutaneously (under the skin) injections"
15757763|NCT04795531|Drug|Placebo insulin degludec|"You will get a pen for weekly injection and one for daily injection. One will be icodec 700 units/mL and the other will be placebo.
~Subcutaneously (under the skin) injections"
15757764|NCT04795505|Behavioral|Intervention|The subsequent visit was through WeChat-based online consultations. Follow-up, assessments and feedback were done at each visit. After follow-up, medication adherence and risk factor modification status were assessed, then individualized feedback, encouragement and recommendations were provided.
15757765|NCT04795505|Behavioral|Control|The subsequent visit was through an offline outpatient clinic at 4 different community hospitals. Participants in this group received standard outpatient cardiology follow-up with formal cardiac rehabilitation and secondary prevention
15757766|NCT04795492|Behavioral|remote intervention|Medication adherence and risk factor modification status were assessed, then individualized feedback, encouragement and recommendations were provided. Risk factor modification included lipid control, smoking and drinking cessation, BP monitoring, dietary change keeping a healthy weight and in our trial. There were also a lot of educational materials about coronary heart disease knowledge that were reviewed by cardiologists, and participants were free to provide them whenever and wherever they want.
15757767|NCT04795492|Behavioral|Routine outpatient follow-up|Participants in this group received standard outpatient cardiology follow-up with formal cardiac rehabilitation and secondary prevention.
15757768|NCT04795479|Drug|Relacorilant|Relacorilant 400 mg (therapeutic dose) or 800 mg (supra-therapeutic dose) capsule by mouth once daily
15757769|NCT04795479|Drug|Placebo to relacorilant|Placebo to relacorilant capsule by mouth once daily
15757770|NCT04795479|Drug|Moxifloxacin|Moxifloxacin 400 mg tablet by mouth
15757771|NCT04795466|Biological|Canakinumab|Biological sub-cutaneous injection
15757772|NCT04795466|Other|Placebo|Matching placebo subcutaneous injection
15757773|NCT04795453|Other|score system to predict the need for surgery|two and more grades of NEC is assessed using the score system to predict the need for surgery
15757774|NCT04795453|Other|usual method to predict the need for surgery|two and more grades of NEC is assessed using the usual method to predict the need for surgery
15757775|NCT04795440|Procedure|Testicular biopsy|Performance of a testicular biopsy with the intention of obtaining spermatozoa for the insemination of oocytes with the ICSI technique.
15757776|NCT04795427|Drug|asciminib|Asciminib comes in 20 mg and 40 mg tablets and is taken orally twice daily
15757777|NCT04795427|Other|best available treatment|Best available treatment will be based on investigator's choice identified prior to randomization. Dose and frequency will depend on label and institutional guidelines for various BAT
15757778|NCT04795414|Biological|SARS-CoV-2 Vaccine(Vero Cell), Inactivated|The subjects of Vaccination Group will receive two doses, 21 days apart of inactivated SARS-CoV-2 vaccine (4 μg of BBIBP-CorV)
15757779|NCT04795401|Device|FRAME FR IFU|The surgeon will use the medical device FRAME to perform the plication procedure. The device will be selected and implanted according to the product IFU.
15757780|NCT04795375|Behavioral|Physical Activity counseling|"The Physical activity counseling techniques will be based on the Self Determination Theory and Five A's (Assess, Advise, Agree, Assist, Arrange). Guidelines for physical activity will include combined aerobic and resistance exercises.
~Each participant in the intervention group will receive personal exercise prescriptions in accordance the post-surgical statues and exercise recommendations after bariatric surgery. Participants will receive long term follow-up and accompaniment during the first six months after the surgery, through Personal meetings with a certified nurse, Phone-calls, motivational massages, and Exercise Videos."
15757781|NCT04795362|Biological|blood sample|"5 tubes of 1 milliliters (ml) will be sampled on a catheter placed as part of the usual practice every hour for 4 hours (at Time 0, at Time 1 hour, at time 2hours, at Time 3 hours, at time 4 hours) as soon as DCI is suspected.
~In the event of a mechanical angioplasty decision, the samples will be continued (Time 0, Time 2 hours, Time 4 hours, Time 6hours, Time 12 hours, Time 24 hours, so 6 samples of 1 ml)."
15757822|NCT04794881|Other|24 hours|Performing a lumbar puncture at 24 hours after a traumatic lumbar puncture
15757935|NCT04793919|Drug|All-trans retinoic acid|See the protocol
15757786|NCT04795310|Device|Pulsed dye laser|"PDL (Vbeam perfecta, 595 nm, Candela Corporation, Wayland, MA) was used with energy dosages of 9-11J/cm2, pulse durations of 10ms/20ms, and 7 or 10 mm handpieces with dynamic cooling device (DCD).
~IPL device (M22, Lumenis Limited, Yokneam, Israel) with integration of sapphire ChillTip system for epidermal cooling were used in the study. Three wavelength bands were configured: 560-1200 nm, 590-1200 nm, and vascular wavelength bands of 530-650nm and 900-1200nm. All the treatment handpieces had a spot size of 15mm×35mm, fluence of 9-17J/cm², pulse duration of 4.0-6.0ms and pulse delay of 20-40ms, underwent the M22 advanced optimal pulse technology (AOPT) treatment."
15757787|NCT04795271|Other|Orthopedic intervention|"In each custom insole, modifications can be included in the following aspects according to the requirements of each participant :
~Forefoot specifications: a) Retrocapital bar, b) Retrocapital support, c) Claw toe correction element, d) Pronating wedge, e) Supinator wedge, f) Metatarsal head pad, g) Selective perforations in the insole, h) Others.
~Midfoot specifications: a) Internal arch, b) External arch, c) Full support, d) Excavations, e) Others.
~Hindfoot specifications: a) Heel cup, b) Supinator wedge, c) Pronating wedge, d) Lifter, e) Cup, f) Others.
~Insole type and lining material
~Materials of the added corrections
~Insole base: a) soft ethylene vinyl acetate (eva), b) semi-soft eva, c) hard eva, d) rubber, e) cuerolite."
15757789|NCT04795232|Other|COD45|Participants will perform 2 sets of 10 sprints. The total distance for each sprint will be 27.6 meters and will include two changes of direction of 45 degrees. The recovery time will be 16 seconds between sprints and 2.20 minutes between sets
15757790|NCT04795232|Other|COD90|Participants will perform 2 sets of 10 sprints. The total distance for each sprint will be 21.2 meters and will include two changes of direction of 90 degrees. The recovery time will be 16 seconds between sprints and 2.20 minutes between sets
15757791|NCT04795206|Other|No Intervention|Administered as specified in the treatment arm.
15757792|NCT04795193|Procedure|Minimal invasive coronary surgery|Off-pump multi-vessel coronary artery bypass grafting via left thoracotomy under minimally invasive conditions.
15757793|NCT04795193|Procedure|Off-pump coronary artery bypass surgery|Off-pump multi-vessel coronary artery bypass grafting with conventional thoracotomy.
15757794|NCT04795180|Drug|Irrigations trough the efferent limb of loop ileostomy|Irrigations trough the efferent limb of loop ileostomy during 4 weeks previous to ileostomy closure
15757795|NCT04795154|Other|Yoga excercise|Yoga exercise in pre-eclampsia >20 weeks of pregnancy woman, treatment number was 4 times.
15757796|NCT04795141|Drug|ABY-035|ABY-035 80 mg Q2W, 160 mg Q4W, 40 mg Q2W; Duration: 52 weeks
15757797|NCT04795141|Drug|Normal saline|Dosage form: Solution for injection; Dosage and frequency: Isotonic saline solution (0.9% sodium chloride),Q2W; Duration: 52 weeks
15757798|NCT04795128|Biological|IBI322|Recombinant anti-human CD47/PD-L1 bispecific antibody injection
15757799|NCT04795115|Other|Auditory rhythmical cueing|Auditory rhythmical cueing intervention targeting balance and gait for 30 minutes x5 per week for 3 weeks.
15757800|NCT04795102|Combination Product|immediate implant placement with ATBG and L-PRF|immediate implant placement using ATBG as a graft material, with L-PRF
15757801|NCT04795102|Combination Product|immediate implant placement with ATBG|immediate implant placement using ATBG as a graft material without L-PRF
15757802|NCT04795089|Procedure|Shunt surgery|Patients are evaluated before and after shunt surgery which is a standard intervention in the clinical practice. HI do not undergo intervention.
15757803|NCT04795076|Dietary Supplement|Infant formula|Regular infant formula will be concentrated to give a calorie density of about 90 kcal/100 mL.
15757804|NCT04795063|Procedure|Total Robotic Distal Gastrectomy|All the surgical procedures are performed using the robot system.
15757805|NCT04795063|Procedure|Robotic-Assisted Distal Gastrectomy|After finishing the lymphadenectomy, the digestive tract reconstruction is performed extracorporal.
15757806|NCT04795050|Behavioral|Project POWER|Diabetes health promotion/cardiovascular disease risk reduction educational curriculum
15757807|NCT04795037|Drug|CU06-1004, Single dose|"Single dose of CU06-1004, 7 dose levels, oral capsule : 6 Cohorts (100mg, 300mg, 600mg, 900mg, 1200mg, 300mg bid) + 1 Cohort (Food effect)＊
~＊Cohort S7(TBD mg) will receive a single oral dose of CU06-1004 or placebo under fed conditions. When administered under fed conditions, CU06-1004 or placebo will be administered following a high-fat/high-calorie breakfast. Cohort S7 will be conducted following completion of Cohort S5"
15757808|NCT04795037|Drug|CU06-1004, Multiple doses|"Multiple doses of CU06-1004, 7 days, 3 dose levels＊, oral capsule
~＊The dose levels, regimen (i.e., schedule), and conditions (i.e., fasted versus fed conditions) will be determined based on the safety, tolerability, and plasma PK data from SAD"
15757809|NCT04795037|Drug|Placebo|Placebo matched to CU06-1004, oral capsule
15757810|NCT04795011|Other|exercise and manual lymphatic drainage|MLD will be launched with simple neck application. Hemodynamics of blood and lower extremity motoring will be increased by combining active bilateral shoulder-twisting with breathing after effleurage. Cervical lymph nodes will be stimulated. Back-up treatment will be applied for the abdominal area. Suction power in the ductus thoracicus will be increased with breathing exercises. Ventral drainage will be applied to the lower extremity in accordance with the surgery of the patient.
15757811|NCT04795011|Other|exercise|range of motion and walking exercise
15757812|NCT04794998|Drug|Recommended treatment schedule|Relatively selective Cox-2 inhibitors, Corticosteroids (Dexamethasone), Anticoagulants (LMW heparin), Gentle Oxygen therapy
15757813|NCT04794998|Drug|Control treatment schedule|Treatment regimens different from the recommended one according to family phisicians personal practice.
15757814|NCT04794972|Drug|GNC-039|Administration by intravenous infusion.
15757815|NCT04794959|Diagnostic Test|Dual-energy CT|CMI patients planned for endovascular stent placement will be contacted and informed about this study prior to their procedure. If they wish to take part in the study, then a date for a pre-operative DECT scan will be arranged. Before scanning the patient will be given a standardized calorie dense drink (Nutridrink). This will take place one week prior to their surgical procedure. Following the surgical procedure, the patient will undergo another DECT scan before discharge.
15757816|NCT04794946|Biological|Covishield|2 IM doses (0.5 mL) of AZD1222(Covishield) at Day 0 and after 6-8 weeks of first dose (Day 42-56 days). This schedule will be followed for the first 100 participants, following which vaccination schedule as per the prevailing Government protocols shall be followed as a part of Adaptive Clinical Trial.
15757817|NCT04794933|Other|Conventional therapy|
15757823|NCT04794881|Other|48 hours|Performing a lumbar puncture at 48 hours after a traumatic lumbar puncture
15757824|NCT04794868|Diagnostic Test|CCTA-derived high risk plaque characteristics|Presence of CCTA-derived high risk plaque characteristics
15757825|NCT04794868|Diagnostic Test|CFD-derived hemodynamic parameters|CFD-derived hemodynamic parameters
15757826|NCT04794855|Diagnostic Test|laboratory tests|routine laboratory tests and biomarkers tests
15757827|NCT04794842|Drug|Tetracaine 5% drops|same as information in the arm/group description
15757828|NCT04794842|Drug|Phenol 90% concentration|same as information in the arm/group description
15757829|NCT04794816|Other|Questionnaire Administration|Complete questionnaire
15757830|NCT04794803|Drug|Reparixin|Reparixin will be administered via oral tablets 1200 mg TID for 7 days. In case of improvement, treatment can be prolonged at discretion of the investigator up to a maximum of 21 days of treatment in total or live discharge from the hospital, whichever comes first.
15757831|NCT04794803|Drug|Standard of care|Standard of care
15757832|NCT04794790|Drug|Buprenorphine/naloxone|Buprenorphine/Naloxone induction via a standard dose protocol
15757833|NCT04794777|Combination Product|Individualised therapy|"Group I - No uptake: treated with conventional SRT against the prostate bed. Group II -Uptake only in the prostate bed: will receive intensity modulated RT (IMRT) including Volumetric Modulated Arc Therapy (VMAT) for prostate bed with simultaneous-integrated boost (SIB) to the PET positive uptake in the prostate bed.
~Group III - Uptake in the prostate bed and involvement of regional lymph nodes in the pelvis: will be treated as Group II plus VMAT for the pelvic lymph nodes with SIB to the PET positive lymph nodes or pelvic lymph nodes salvage lymph node dissection (SLND).
~Group IV - Uptake in regional lymph nodes only: will be treated with VMAT for the pelvic lymph nodes with SIB to the PET positive lymph nodes or pelvic lymph nodes SLND.
~Group V - Uptake in extra-pelvic lymph nodes or bone metastasis: systemic treatment instead of surgery or radiation. Local treatment with surgery or radiation is acceptable if curative intention."
15757834|NCT04794777|Radiation|Standard salvage therapy|Standard salvage radiotherapy
15757835|NCT04794764|Device|McGrath Mac|in a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea.
15757836|NCT04794764|Device|Macintosh Laryngoscope|in a randomized order we evaluate the first pass success rate of the tracheal tube into the trachea.
15757837|NCT04794738|Drug|SHR8554|SHR8554 Injection; high dose
15757838|NCT04794738|Drug|SHR8554|SHR8554 Injection; low dose
15757839|NCT04794738|Drug|Saline Solution|Saline Solution
15757840|NCT04794738|Drug|Morphine|Morphine
15757841|NCT04794725|Procedure|Blood sampling|blood samples from venepuncture (10mL)
15757842|NCT04794712|Device|Venous reflux tools (Ultrasound and Photo plethysmography (PPG))|Venous reflux tools Pain assessment tools
15757844|NCT04794673|Other|brain damage|Have or not have the brain damage and the location of the damage
15757845|NCT04794660|Diagnostic Test|HPV DNA Test|Screening for HPV using a HPV DNA test
15757846|NCT04794660|Diagnostic Test|VIA triage test|"VIA is a technique in which cervical neoplastic lesions are visually diagnosed after application of 3-5% acetic acid without using any magnification device.
~After application of 3 - 5% acetic acid, using the naked eye, the cervix is examined for the presence of an aceto-white lesion located in the transformation zone. The results are classified as either positive or negative, inadequate or suspicion of cancer"
15757847|NCT04794660|Procedure|Treatment by ablative treatment|Cryotherapy or Thermal Ablation are performed on the cervix.
15757848|NCT04794660|Procedure|Colposcopy|Colposcopy visit are offered to women with non visible squamous columnar junction or ineligible for ablative treatment.
15757849|NCT04794647|Other|Cervical mobilization|A kind of manual therapy tecnique applied to the cervical region
15757850|NCT04794647|Other|Placebo mobilization|It was applied to the randomly selected cervical faset without any pushing or pulling in the same position and the same grip with cervical mobilization.
15757851|NCT04794634|Diagnostic Test|Optical coherence tomography (OCT)|to make a complete ophthalmological and neurological examination, an OCT to AD and to compare their results with LD and controls subjects
15757852|NCT04794634|Diagnostic Test|Optical coherence tomograpohy angiography (OCTA)|to make a complete ophthalmological and neurological examination, an OCT and OCTA, to AD and to compare their results with LD and controls subjects
15757853|NCT04794621|Device|Electroceutical Dressing Technology-EDThi|Use of EDThi for 3 weeks post enrollment
15757854|NCT04794621|Device|Adding EDTlo (Procellera®) for 3 weeks after use of EDThi|Use of EDTlo (Procellera®) for additional 3 weeks
15757855|NCT04794608|Device|HYPNO VR® device|"The HYPNO VR® device is a software application of medical hypnosis in the treatment of pain and anxiety. It is associated with equipment: a virtual reality headset and a headphone.
~Before each session of hypnosis, the nursing staff offers patients the choices: visual universe, musical theme, male or female voice. The nursing staff selects the program, selects a duration of 20 minutes and presses start to start the medical hypnosis session in virtual reality.
~After completing the hypnotic trance sequence, as in a classic session, the patient is brought back to the return and exit hypnosis phase under the supervision of the nursing staff."
15757856|NCT04794595|Procedure|CBP|continuous blood purification can prevent or treat fluid overload in children with septic shock or other sepsis-associated organ dysfunction who are unresponsive to fluid restriction and diuretic therapy management of septic AKI patients, particularly those with hemodynamic instability or fluid overload. Also, it can remove cytokines
15757857|NCT04794582|Device|ProGrip® Polypropylene Self-Gripping Mesh|Supra-aponeurotic placement of ProGrip® macroporous polypropylene monofilament mesh in the supra-aponeurotic position
15757858|NCT04794569|Drug|tinzaparin|low molecular weight heparin
15757859|NCT04794569|Drug|Rivaroxaban|direct oral anticoagulant
15757860|NCT04794556|Device|tight-fitting of KF94 mask with clip|The general-fitting method involved wearing a mask with ear loops, and the tight-fitting method involved wearing a clip that connected ear loops on the occiput after wearing a mask according to the general method
15757863|NCT04794517|Drug|Dapagliflozin 10Mg Tab|Dapagliflozin 10 mg/die will be administered orally for six-weeks.
15757864|NCT04794517|Other|Placebo|Placebo one tablet/die will be administered orally for six-weeks.
15757865|NCT04794504|Drug|Botox 100 UNT Injection|Botox will be injected intramuscularly into the masseter and temporalis muscles bilaterally to investigate if it can supplement postoperative analgesia in orthognathic surgery patients
15757866|NCT04794504|Other|0.9% Saline Injection|As a placebo control to the 100 UNT Botox injection, 0.9% saline will be injected intramuscularly into the masseter and temporalis muscles bilaterally
15757867|NCT04794491|Drug|JZP-258|Maximum nightly dosage of 9 grams, administered once, twice or thrice nightly, with no single dose > 6 g
15757868|NCT04794478|Device|Dexcom Continuous Glucose Monitoring System|Dexcom Continuous Glucose Monitoring System
15757869|NCT04794465|Diagnostic Test|Colorectal cancer screening|Patients with IBP diagnosed during the colorectal cancer screening
15757870|NCT04794452|Device|Battery operated toothbrush|Device on plaque removal efficacy
15757871|NCT04794452|Device|Manual toothbrush|Device on plaque removal efficacy
15757872|NCT04794439|Drug|Dentifrices|Dentifrice on plaque
15757873|NCT04794426|Drug|Silver diamine fluoride|Previous studies have recommended that Silver diamine fluoride (SDF) solution would exert a preventive result in managing early childhood caries ECC. However, no well-designed clinical trials have yet been performed to study the effect of SDF on caries prevention. the objective is useful in arresting early childhood caries (ECC)
15757874|NCT04794426|Device|Hall Technique|The first report on the Hall Technique published in 2007 by a general dental practitioner from Aberdeen/Scotland, Dr. Norna Hall. Dr. Hall used PMCs to restore carious primary molars rather than using the standard technique, placed them using a simplified method.
15757875|NCT04794413|Drug|Pimavanserin|Pimavanserin is a serotonin receptor inverse agonist used in treatment of psychosis in Parkinson's disease.
15757876|NCT04794400|Other|oxygen mask|All patients fulfilling inclusion criteria would be offered to test the intervention as part of their care. The intervention consisted only of a standardised way to evaluate this new clinical routine.
15757877|NCT04794387|Biological|Amended LLS COVID-19 Registry|Do people with blood cancer who did not develop antibodies after a complete COVID-19 vaccination, develop antoibodies after a COVID-19 booster?
15757878|NCT04794374|Other|Telerehabilitation|Telerehabilitation will consists of physiotherapist-guided exercises. Exercises will be designed by physiotherapists for COVID-19 survivors using the current guidelines. Exercise brochure will be prepared and will be sent to participants. Repetitions and sets of exercises will be modified according to the patients.
15757879|NCT04794348|Biological|Fresh Frozen Plasma (FFP)|Autologous units of fresh frozen plasma collected from the subject by plasmapheresis
15757880|NCT04794348|Biological|Freeze Dried Plasma (FDP)|Autologous units of freeze dried plasma manufactured from plasma collected from the subject by plasmapheresis
15757881|NCT04794322|Diagnostic Test|Uterine lavage, or a wash of the womb|Uterine lavage is performed during surgery using a flexible, 3-way balloon tipped catheter. The catheter is inserted through the cervix, the balloon expanded and the uterine cavity lavaged using 10 cc of sterile saline which is collected, processed and stored for later analysis.
15757882|NCT04794322|Diagnostic Test|Blood sample|Participants undergo two blood draws (one required, one optional) up to 31 days before surgery
15757883|NCT04794322|Diagnostic Test|Pap smear|Participants undergo a standard Papanicolaou smear to collect cells and fluid from the cervix.
15757884|NCT04794309|Other|Circuit training exercise|"circuit training exercise start with 5 minutes of warming-up then followed by a 30-minute conditioning protocol formed 20 minutes of aerobic exercise and 10 minutes of resisted exercise. The cool-down period is doing in form of walking on a treadmill in low intensity for 5 minutes.
~Aerobic exercise will be performed on an electronically-braked cycle ergometer (Quinton Excalibur, QuintonInstrument Company, Bothell, WA). resistance exercise (RT) in the form of eight different exercises will be performed during each workout: military press, leg extension, bench press, standing leg curl (ankle weights), lateral pull-down, dumbbell triceps push-down, dumbbell seated biceps curl, and sit-ups (abdominal curls).
~The participant will do 10 minutes for Aerobic exercise followed by 10 minutes of resistance exercise then 10 minutes for Aerobic exercise. This cycle training will perform five days per week for eight weeks."
15757885|NCT04794309|Dietary Supplement|Healthy high Fiber diet|The diet will be tailor-made for the individual for the body type and obesity in consultation with the nutritionist.
15757886|NCT04794283|Other|Breast milk|Milk substitute given during the first 24h
15757887|NCT04794270|Device|ACUVUE OASYS® 1-Day for Astigmatism - TAM 24|TEST
15757888|NCT04794270|Device|ACUVUE OASYS® 1-Day for Astigmatism|CONTROL
15757889|NCT04794257|Device|Neuromonitoring of the recurrent laryngeal nerves|The NIM Vital system (Medtronic, Jacksonville, US) operates with surface electrodes integrated with an endotracheal NIM TriVantage tube 7.0-8.0 in diameter, which is inserted by an anesthetist between the vocal folds under direct vision during intubation. The standardized technique of IONM RLNs wll be used, including initial vagal response evaluation at the beginning and final vagal response evaluation at the end of surgery (IONM = L1+V1+R1+R2+V2+L2) according to the recommendations formulated by the International Intraoperative Neural Monitoring Study Group. The nerves will be stimulated using a monopolar electrode and the interrupted stimulation technique at 1mA, 100ms impulse duration and 4Hz frequency. In case of the bifurcated RLN nerves, the assessment includes post-stimulation response of each nerve branch. Adduction of the vocal folds is detected by the endotracheal tube electromyography and abduction by finger palpation of muscle contraction in the posterior cricoarytenoid.
15757927|NCT04793958|Drug|FOLFIRI Regimen|"Fluorouracil
~Irinotecan
~Folinic acid"
15757928|NCT04793945|Combination Product|topical steroid and 308nm-Excimer light therapy|applying topical steroid in combination with 308nm-Excimer light therapy to treat Alopecia Areata
15757929|NCT04793932|Drug|PAXG|Nab-paclitaxel, cisplatin and gemcitabine drugs will be administered on day 1 and 15 every 28 days. Capecitabine tablets will be taken orally on days 1 to 28, every 28 days
15757930|NCT04793932|Drug|mFOLFIRINOX|Oxaliplatin, folinic acid, irinotecan and 5-Fluoruracil will be administered on day 1 and 15 every 28 days
15757890|NCT04794244|Behavioral|ASGE-FABES Program|In the control group study, pretest-posttest and experimental design with repeated measurements were used in randomized groups. An overweight and obese adolescent constituted the sample of 250 (125-experiment, 125-control) of the study. Research data Socio-Demographic Features Information Form, Adolescent Nutrition Information Scale, Adolescent Physical Activity Information Scale, Adolescent Lifestyle Scale, Healthy Lifestyle Choice Scale for Adolescents, Beck Anxiety Scale, Daily Food Consumption Form, Beverage Consumption Form, collected using. Data are saved before and after application. ASGEFABES PROGRAM was applied to the experimental group for 10 weeks. Measurements after the training program were collected in four measurements: 1st week, 6th and 12th months.
15757891|NCT04794231|Other|Standard dressing|a standard breathable, hypoallergenic, transparent dressing (TegadermTM 1635 [8.5 x 10.5cm] or 1633 [7 × 8.5 cm] depending on patient size; 3M, Neuss, Germany)
15757892|NCT04794231|Other|Chlorhexidine gluconate -impregnated dressing group|A chlorhexidine gluconate -gel impregnated transparent dressing (TegadermTM CHG 1660R [7 x 8.5 cm] or [11.5 x 8.5 cm] depending on patient size; 3M, Neuss, Germany).
15757893|NCT04794218|Drug|rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^4|rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^4
15757894|NCT04794218|Drug|rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^5|rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^5
15757895|NCT04794218|Drug|rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^6|rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^6
15757896|NCT04794218|Drug|rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^7|rVSV∆G-LASV-GPC Vaccine Dosage (pfu) intramuscularly Day 1 2 X 10^7
15757897|NCT04794218|Other|Placebo|Placebo (matched diluent)
15757898|NCT04794205|Drug|Low Dose Beta-Caryophyllene|5 mg BCP
15757899|NCT04794205|Drug|Medium Dose Beta-Caryophyllene|30 mg BCP
15757900|NCT04794205|Drug|High Dose Beta-Caryophyllene|150 mg BCP
15757901|NCT04794205|Drug|Placebo|Placebo drug.
15757902|NCT04794179|Device|Naida Link CROS|Individuals 65+ who already have Advanced Bionics CII/90K/Ultra cochlear implants will be given Naida Link CROS device to assess the effect the device has on speech understanding in challenging listening situations and on the quality of life in unilateral cochlear implant recipients and their frequent communication partners.
15757903|NCT04794153|Dietary Supplement|whole food sources|Foods selected are naturally high in protein and consumed by the general population as part of a meal.
15757904|NCT04794140|Procedure|different number of passes|Each patient's operation process is the same, that is, after obtaining enough specimens for diagnosis by endoscopic ultrasound-guided fine-needle biopsy (EUS-FNB) wet suction technique, additional three passes are performed. One of which is randomly selected as the one pass group, and the other two passes automatically as the two pass group. Please refer to the literature for EUS-FNB wet technique (Tong T, et al. J Gastroenterol Hepatol. 2020;10.1111/jgh.15371.)
15757905|NCT04794127|Drug|Trabectedin|Patients will be treated with Trabectedin administered at a dose of 1.5 mg/m2-1.3 mg/m2 (according to investigator's choice, with a top-dose of 2.6 total mg per cycle) as a 24-hour continuous infusion via a central venous access every 3 weeks and pioglitazone given continuously at the daily dose of 45 mg by oral route.
15757906|NCT04794127|Drug|Pioglitazone Oral Product|Patients will be treated with Trabectedin administered at a dose of 1.5 mg/m2-1.3 mg/m2 (according to investigator's choice, with a top-dose of 2.6 total mg per cycle) as a 24-hour continuous infusion via a central venous access every 3 weeks and pioglitazone given continuously at the daily dose of 45 mg by oral route.
15757907|NCT04794114|Device|experimental ankle foot orthosis|On the basis of an accurate kinetic and kinematic analysis, a customized orthosis in thermoplastic material with carbon inserts will be created that will make the brace more elastic and facilitate the child's motor activities.
15757908|NCT04794114|Device|traditional ankle foot orthosis|The normal afos in thermoplastic material, while guaranteeing an ankle joint stability, make the joint more rigid and reduce the elasticity of movement especially during running, jumping and sprinting.
15757909|NCT04794101|Biological|Genetic: AAV5-RPGR 4e11|Bilateral, subretinal administration of AAV5-RPGR - deferred treatment group
15757910|NCT04794101|Biological|Genetic: AAV5-RPGR 2e11|Bilateral, subretinal administration of AAV5-RPGR - deferred treatment group
15757911|NCT04794088|Drug|Imatinib Mesylate intravenous solution|A 25ml volume of IMP will be administered over 2-hours as an intravenous infusion. This corresponds to a dose of 200mg imatinib (100mg/h).
15757912|NCT04794088|Drug|Placebo|A 25ml volume of IMP will be administered over 2-hours as an intravenous infusion. This corresponds to a dose of 25ml placebo (12.5ml/h).
15757914|NCT04794049|Drug|Lactulose|In experiment cohort, patients do not use standard bowel preparation regimen, they totally drink 300ml lactulose.
15757915|NCT04794049|Drug|Polyethylene Glycol (PEG)|In control cohort, patients use the standard split-dose bowel preparation regimen,
15757916|NCT04794036|Other|Asynchronous telerehabilitation programme|Home-based physical rehabilitation programme using a telerehabilitation platform
15757917|NCT04794036|Other|Rehabilitation programme|Home-based physical rehabilitation programme by means of an explanatory booklet
15757918|NCT04794023|Device|Corneal Ablation|Corneal ablation for the treatment of myopia with/without astigmatism following flap creation using femtosecond laser.
15757919|NCT04793997|Biological|Microbiome spray|Throat spray containing 3 beneficial lactobacilli strains
15757920|NCT04793997|Biological|Placebo spray|Throat spray
15757921|NCT04793984|Device|Carragelose|inhalation 3 times a day
15757922|NCT04793984|Device|NaCl|inhalation 3 times a day
15757923|NCT04793971|Procedure|percutaneous paratenon release|percutaneous paratenon release for chronic midportion Achilles tendinopathy
15757924|NCT04793958|Drug|MRTX849|28 Day Cycle
15757925|NCT04793958|Biological|Cetuximab|28 Day Cycle
15757926|NCT04793958|Drug|mFOLFOX6 Regimen|"Fluorouracil
~Oxaliplatin
~Folinic acid"
15757936|NCT04793906|Other|Iron supplement with a lunch meal containing beef|Participants will consume a lunch meal containing beef with an iron supplement for 8 weeks.
15757937|NCT04793906|Other|Iron supplement with a lunch meal containing plant-based alternative|Participants will consume a lunch meal containing plant-based alternative with an iron supplement for 8 weeks.
15757938|NCT04793893|Device|ReLex Smile|With the ReLex Smile the optical zone (lenticule diameter) and cap diameter are 6.5 and 7.5 mm respectively. After dissection of both anterior and posterior planes, the lenticule is extracted through 120 degree superior 3.5 mm incision and marked with a sterile marker (ViscotMedster).
15757939|NCT04793880|Behavioral|Medication Cost Information|This version of the HFrEF medication checklist includes patient-specific estimated monthly out-of-pocket cost for each medication. TailorMed, a company designed to provide financial counseling and planning for patients, will generate the patients' out-of-pocket cost based on insurance status. The costs for non-generic HFrEF medications will then be populated onto a checklist of recommended heart failure medications so that patients and their clinicians will have this information available during their clinical encounter.
15757940|NCT04793880|Behavioral|Heart Failure Medicines Checklist|The Heart Failure Medicines Checklist is an evidence-based medication checklist that describes guideline-recommended medications for HFrEF. This tool is used during the clinical encounter to facilitate a discussion about medications that may be most appropriate for the patient.
15757941|NCT04793867|Diagnostic Test|Xenon|"Subjects will be scanned on a commercial 3T whole-body MRI scanner equipped with high-performance gradient systems. Natural isotopic abundance or isotopically-enriched xenon gas (~86% 129Xe, Linde Inc.) will be used for all studies. Subjects will be positioned supine in the scanner with a 129Xe RF coil around their chests. Using conventional proton MRI and a breath-hold acquisition, scout images will be obtained to localize the subject for subsequent 129Xe acquisitions. 129Xe images will be acquired using the same breath-hold maneuver and a pulse sequence, covering the entire lung (acquisition time <10 s, approximately 3-mm in-plane resolution, 15-mm slice thickness or less). Additional scans (sequences) may be performed. A maximum of 4 doses of 129Xe will be given throughout the study following the calibration dose."
15757942|NCT04793854|Other|Measure of the Life habits (MHAVIE)|"Life habits include daily activities and social in 6 groups. Environmental factors include social (9 different subgroups) and physical factors (7 different subgroups).
~Personal factors are person related parameters (gender, age, sociocultural ethnic, skills, deficiencies factors,…)."
15757943|NCT04793841|Other|self-sampling kits for STI testing in laboratory|participants in both groups will receive self-sampling kits and deliver the collected samples to laboratory for testing
15757944|NCT04793828|Behavioral|Velibra|Velibra is an internet-based cognitive behavioral therapy program developed by GAIA AG. It consists of six modules which are meant to be completed over a span of 6 weeks. The first module educates participants about anxiety and the treatment program. The second module focuses on cognitive techniques for dealing with anxiety. In the third module, relaxation techniques are practiced. The fourth module encourages the participant to practice non-anxious behaviors. In the fifth module, the central topic is the experience of social situations in non-anxious ways. The sixth and final module consists of a summary and recapitulation of the most important content.
15757945|NCT04793815|Procedure|Cryo-activation|The cryo-activation procedure involves the insertion of a cryoprobe in the tumor bed with subsequent application of very low temperatures leading to cell necrosis and tumor antigens release.
15757946|NCT04793815|Drug|Pembrolizumab|Following the cryo-activation procedure, patients will sequentially be treated with pembrolizumab (anti-PD-1) monotherapy.
15757947|NCT04793802|Other|PHYSIO|session of physiotherapy
15757948|NCT04793789|Other|monofocal toric lens|not applicable as patients are already implanted with the monofocal toric lens
15757949|NCT04793776|Behavioral|Manage Emotions to Reduce Aggression|MERA begins with education about the adaptive nature of emotions, how childhood and military experiences can influence emotion regulation, and how combat requires different emotion regulation strategies than most civilian environments. MERA use modeling and practice with feedback to teach cognitive-behavioral and acceptance-based emotion regulation skills.
15757950|NCT04793776|Behavioral|Present Centered Psychotherapy|PCT will serve as the comparison group. PCT assists Veterans in understanding and coping with current difficulties, such as aggression, but does not provide systematic training in emotion regulation skills.
15757951|NCT04793763|Other|traditional therapeutic exercises|group A will receive traditional exercises
15757952|NCT04793763|Other|traditional therapeutic exercises and McKenize technique|Group B will receive traditional therapeutic exercises and McKenize technique
15757953|NCT04793763|Other|traditional therapeutic exercises and deep neck flexor exercises|Group C receive traditional therapeutic exercises and deep neck flexor exercises
15757954|NCT04793750|Diagnostic Test|Cepheid GeneXpert HIV-1 Qual POC HIV VL test|POC Nucleic acid-based test for HIV RNA.
15757955|NCT04793750|Diagnostic Test|DPP HIV-Syphilis test system|POC Tests for antibodies to HIV 1/2 and Treponema pallidum.
15757956|NCT04793750|Diagnostic Test|OraQuick|POC oral fluid swab test for HIV 1/2 antibodies.
15757957|NCT04793737|Radiation|Precision Radiation (SBRT)|Precision radiation of melanoma metastases
15757958|NCT04793724|Device|Simeox|"A respiratory physiotherapy session with the Simeox device will be performed in accordance with the official PhysioAssist recommendations, which are;
~clearance of the upper airways before the physiotherapy session
~correct position of the mouthpiece in patient's mouth, with the lips placed on the thinnest part of the mouthpiece and the tongue positioned underneath the mouthpiece
~slow nasal inhalation without too much recruitment of the inspiratory residual volume (IRV) and an exhalation with real deflation of the thorax
~step-by-step shifting of the patient's tidal volume towards the expiratory residual volume (ERV), in order to target the most distal regions of the lungs
~comfortable, relaxed sitting position with straightened spine
~controlled cough, which will be encouraged only when it is productive"
15757993|NCT04793451|Behavioral|Endurance training|The women in group A underwent endurance exercise on cycle ergometers (Schwinn Evolution, Schwinn Bicycle Company, Boulder, Colorado, USA). Exercise sessions consisted of a five-minute warm-up (stretching exercise) at low intensity (50%-60% of maximum heart rate), a 45-minute exercise (at 50%-80% of maximum heart rate), five minutes of cycling without a load, and five minutes of closing stretching and breathing exercise of low intensity.
15758283|NCT04790903|Drug|Prednisone|Participants will receive Prednisone orally (PO) at a dose of 100 mg/day on Days 1-5 of Cycles 1-6.
15757959|NCT04793724|Device|PARI O PEP|"ACT with PARI O-PEP will be performed in an upright sitting position, using four positions of the device for the most effective clearance of mucus from the lungs. These positions will be:
~horizontal;
~low;
~transition of the device from the low position to the horizontal position;
~upside down.
~The mouthpiece will be placed between the patient's teeth as per standard procedure, and enclosed properly within the lips. Patients will perform slow and deep inhalation via the nose, then hold their breath for about 1 to 2 seconds at the end of inhalation. Exhalation will be performed slowly and completely into the PARI O-PEP through the patient's mouth. At the end of the session, the patient will perform huffing with the PARI O-PEP device in the upside down position in order to maintain open airways, and, if possible, expectoration sputum."
15757960|NCT04793711|Device|EpiCeram|Barrier cream
15757961|NCT04793698|Other|Compassion meditation|10 week meditation course taught in 90-minute groups
15757962|NCT04793698|Behavioral|Applied relaxation|10 week applied relaxation course taught in 90-minute groups
15757963|NCT04793685|Drug|Prazosin|Prazosin (16mg/day) versus Placebo comparator, with a 2 week titration period, 9 weeks at full dose and a 5-day taper in week 12.
15757964|NCT04793685|Behavioral|12-Step Facilitation with Relapse Prevention and Contingency Management|12-Step Facilitation and relapse prevention weekly support and Contingency Management with vouchers for each weekly appointment to support treatment attendance for all subjects.
15757965|NCT04793672|Other|Tongue images, coating on the tongue and clinical data of patients with malignant tumors and healthy people will be collected.|Tongue images, coating on the tongue and clinical data of patients with malignant tumors and healthy people will be collected.
15757966|NCT04793659|Drug|Oral Fasudil 90 mg/day|Oral tablet
15757967|NCT04793659|Drug|Oral Fasudil 180 mg/day|Oral tablet
15757968|NCT04793659|Drug|Oral Placebo|Oral tablet
15757971|NCT04793633|Combination Product|LINFU™ Technique|Non-focused ultrasound excitation of the pancreas with IV Lumason and IV secretin injected during the ultrasound procedure.
15757972|NCT04793620|Other|TQL1055|Semisynthetic saponin adjuvant
15757973|NCT04793620|Biological|Acellular pertussis vaccine|Acellular pertussis vaccine
15757974|NCT04793607|Other|Pleural procedures|Any pleural procedure that removes fluid
15757975|NCT04793594|Other|Berg Balance Test|Patients evaluate with Berg Balance Test for balance
15757976|NCT04793594|Other|Tinetti Balance And Gait Test|Patients evaluate with Tinetti Balance And Gait Test for balance
15757977|NCT04793594|Other|Time Up And Go Test|Patients evaluate with Time Up And Go Test for balance
15757978|NCT04793581|Device|Atherectomy|Directional atherectomy of lesions below the knee.
15757979|NCT04793568|Drug|Recombinant Interferon gamma 1b (IMUKIN®)|100 µg/0,5ml subcutaneous injections from day 1 to day 9 (5 injections, i.e. 1 injection of 100 µg every 48h)
15757980|NCT04793568|Drug|Recombinant Interferon gamma 1b placebo|5 subcutaneous injections from day 1 to day 9 (i.e. 1 injection of 0,5ml every 48h).
15757981|NCT04793555|Other|Monitoring by unobtrusive sensors|During the study the behavior of daily activities will be monitored by unobstructive sensors. Most of the sensors will be mounted on the wall or on furniture with direct sight to the participant and thus will not have any physical contact, except some wearables during the stay in the apartment and at home (e.g. watch, mobile polysomnography).
15757982|NCT04793542|Procedure|lower-limb hot water immersion|For a minimum of 30 minutes, 3 times a week for 8 consecutive weeks, participants will submerge their lower-limbs into 30-32°C (lukewarm) or 39-40°C (hot) water which will be measured with a supplied waterproof thermometer.
15757983|NCT04793529|Drug|Cholecalciferol|Cholecalciferol injection
15757984|NCT04793516|Other|VR Therapy Game|Participants will complete 5 sessions of VR-based therapy modules developed for use in helping people with spatial neglect. These 5 sessions will be completed over 7-8 days.
15757985|NCT04793503|Other|conventional complete denture|the complete denture constructed by packing technique
15757986|NCT04793503|Other|CADCAM 3D printed denture|The files from the laser-scan will be translated into stereolithography (STL) files and the CDs are virtually designed in ExoCad software
15757987|NCT04793503|Other|CAD/CAM milled denture|Once the complete denture has been virtually designed in CAD software (ExoCad software) a preview will be sent for evaluation using 3D viewing software
15757988|NCT04793490|Procedure|Sphenopalatine ganglion block|Patients will receive the SPGB via the transnasal approache by a cotton tipped applicator soaked in lignocaine 2% with 4 mg dexamethasone
15757989|NCT04793490|Drug|paracetamol|patients will receive paracetamol 1 g thrice daily intravenously
15757990|NCT04793477|Device|instrumentation technique in pulpectomies|comparison of three file systems for pulpectomies in primary molars
15757991|NCT04793464|Behavioral|Promotores de Salud|The Promotores de Salud intervention is delivered by a paid Promotor(a) who is a trusted member of the community where the testing site is located. The intervention includes: (1) psychoeducation to increase knowledge about COVID-19 and the benefits of testing; (2) motivational interviewing (MI) strategies to explore personal, social, and behavioral barriers to testing and to discuss available resources to resolve these barriers; (3) emotional support to address testing-related concerns and anxieties that may dissuade Latinx individuals from getting tested; and (4) service navigation. When promotores are on-site at testing events, they will provide information about COVID-19 and preventive behaviors using in-person instruction on effective mask wearing, hand washing, and physical distancing, as well as the importance of repeated testing and vaccines.
15757992|NCT04793464|Behavioral|Services as usual|Services as usual, our control condition, includes strategies that are typically conducted by county and community-based organizations that serve under-represented groups to notify people of testing opportunities related to COVID-19. These include Facebook advertisements, email announcements, circulation to other community-based organizations and state agencies (e.g., Oregon Health Authority, county public health), and other flyer distribution means. This condition also includes a pamphlet about health behaviors and community resources handed out by testing facilitators at testing events.
15758177|NCT04791774|Dietary Supplement|Fee amino acids (food grade amino acids)|Nutritional formula containing 20 grams of a free amino acid mixture equivalent in composition to the milk protein with 1-[13C]-labeled phenylalanine
15757994|NCT04793451|Behavioral|Endurance-strength training|Group B performed endurance-strength exercise consisting of a five-minute warm-up (stretching exercises) of low intensity (50%-60% of maximum heart rate), a strength component, an endurance component, 5 minutes cycling without a load, and a 5 minutes closing stretching and breathing exercise of low intensity. The 20-minute-long strength component was performed using a neck barbell and a gymnastic ball. Directly after the strength exercise, the women took part in a 25-minute endurance exercise on cycle ergometers (Schwinn Evolution, Schwinn Bicycle Company, Boulder, Colorado, USA) at 50%-80% of maximum heart rate.
15757995|NCT04793438|Behavioral|Motive-specific intervention|Three appointments are made with the patients of the intervention group within two weeks. With an adaptation of the Autobiographical Memory Test (AMT) participants will be asked to recall events from the past and to imagine future events. The time frame of 45 minutes for each intervention must be strictly adhered to. Patients are additionally asked to complete tasks between the sessions. All appointments take place in the Psychiatric University Hospital directly on the ward.
15757996|NCT04793438|Behavioral|Supportive conversations|Since we want to check whether the patients benefit from the specific intervention and not only from getting more speaking time, patients without the motive-specific intervention should also be given three sessions, in which no intervention takes place. They will be carried out in the sense of supportive conversations (i.e. conversations that do not follow a specific psychotherapy concept). All appointments take place in the Psychiatric University Hospital directly on the ward.
15757997|NCT04793425|Behavioral|Mobile application (afterAMI)|"The rehabilitation process of the patients in the intervention group will be supported by the mobile application (afterAMI) with synchronized, dedicated web page.
~Patients in the intervention group will be given an access to educational data regarding their individualized diseases. Additionally every patient will receive regularly messages with notifications regarding lifestyle and adherence to the therapy. All reported vital signs (blood pressure, heart rate, weight and many more) will be analyzed every day and in case of need a short message will be sent to the patient with indication to go to the primary healthcare clinic/hospital.
~Additionally, application will send notifications with reminders to take drugs."
15757999|NCT04793399|Drug|Bosutinib 400 MG Monotherapy|One cycle (28 days) only with bosutinib 400 mg/day therapy at the beginning of the trial + 12 cycles with bosutinib 400 mg/day therapy after combined therapy
15758000|NCT04793399|Drug|Bosutinib 400 MG + Atezolizumab 840 MG in 14 ML Injection|12 cycles with bosutinib 400 mg/day plus atezolizumab 1680 mg q4w therapy between the monotherapy bosutinib cycles
15758001|NCT04793386|Diagnostic Test|carotid ultrasound|Every time checking pulse, evaluate the carotid artery compressibility and pulsatility by ultrasound
15758002|NCT04793373|Device|Syringe|A syringe will be used to detect the loss of resistance and needle's entry of epidural space.
15758003|NCT04793360|Device|LiverCare|The LiverCare kits contains Streck tubes and PAX gene tubes, which will be collected at the surveillance schedule outlined above, but also prior to any liver biopsy or DSA measurement. For patients who have a histological diagnosis of allograft rejection who are undergoing treatment, serial monitoring of LiverCare will be performed following the schedule above. All research blood tests will be timed with standard clinical testing to avoid any additional needle sticks.
15758004|NCT04793347|Device|shock master (shock waves device)|device produces shock waves
15758005|NCT04793334|Procedure|sleeve gastectomy|routine sleeve gastrectomy
15758006|NCT04793321|Device|Baby carrier|"It is made in china.
~It is made of Cotton-Polyester.
~It has 3 belts - 2 shoulder belts and one waist belt for superior lumbar support. Shoulder straps are padded and adjustable for the parent's comfort. It has webbing straps for shoulder and waist strap adjustment.
~It is suitable for newborn to 12-months baby
~It is available online at babyshopstores https://www.babyshopstores.com/"
15758007|NCT04793321|Device|Biodex Balance System|"The Biodex Balance System SD (The Biodex Balance System SD Model 945-300, 115 VAC, Shirley, NY, USA) is used to assess the balance in this study.
~It is an objective device that measures dynamic postural stability. It uses a circular platform that allows up to 20˚of of platform tilt in a 360˚ range of motion.
~The measures of postural stability score for BBS are the Overall Stability Index (OSI), Medial-Lateral Stability Index (MLSI), and Anterior-Posterior Stability Index (APSI). These indices are standard deviations that assess the path of sway around the zero point from the center of the platform and are measured in degrees. A high score in these stability indices indicates poor balance."
15758008|NCT04793321|Other|Infant mannequin|The mannequin infant has 3 Kg which corresponds to the infant's age from birth until 1month. This weight is selected as it corresponds to the age at which the infants are frequently carried by the mother .
15758009|NCT04793321|Device|Biodex gait trainer 2 TM|"Gait Trainer 2™ ( model number:950-385, 115 VAC 50/60 Hz, made in the USA) is used for participants to walk on as walking is one of the most common daily life activities. because caregivers commonly walk while carrying their infants as it has a calming effect on crying infants
~It consists of :
~Display: Use Audio and Visual Biofeedback - real-time biofeedback prompts patients into a proper gait pattern.
~Heart Rate Monitoring
~Handrail
~Open Platform"
15758010|NCT04793308|Other|Endodontic files|Engine-driven nickel titanium Ni-Ti instruments
15758011|NCT04793295|Drug|MT-7117|MT-7117
15758012|NCT04793282|Behavioral|Telephone Follow-up|Telephone Follow-up within 72 hours to discuss psycho education, discharge planning and clarify any questions they may have.
15758013|NCT04793269|Other|No intervention|no intervention
15758014|NCT04793256|Device|Fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride).|5% sodium fluoride Varnish is a fluoride varnish which is applied to tooth surfaces
15758015|NCT04793256|Device|Resin based fissure sealant (3M Clinpro Sealant)|teeth will be isolated with cotton rolls and saliva ejector than etching for pits and fissure sealant
15758016|NCT04793243|Dietary Supplement|Vitamin D3|Patients received oral supplementation of 10,000 IU daily for fourteen days of vitamin D3
15758017|NCT04793230|Diagnostic Test|biopsying|The procedure was carried out under general or local anesthesia. An otolaryngologist conducts the endoscopic intranasal operation, while an eye surgeon removes tissue from the sac and lacrimal tubes using lacrimal probes passed through the canaliculi.
15758284|NCT04790890|Device|Optical coherence tomography (OCT)|Optical coherence tomography (OCT) is a non-invasive imaging test which uses light waves to take cross-section pictures of the retina.
15758018|NCT04793217|Behavioral|Improving AIDS Care After Trauma +|ImpACT+ integrates skills for HIV treatment adherence and coping with trauma, tailored to the South African context. This includes exploration of values informing care engagement, recognizing the synergistic stress of sexual trauma and HIV, understanding the contribution of stressors to maladaptive coping, and developing adaptive methods for coping as alternatives to avoidance. ImpACT+ will be delivered in private spaces at the primary care clinic and will consist of 6 individual sessions followed by 6 maintenance check-ins. Individual sessions focus on coping, adherence, and care engagement during an early critical period, while maintenance check-ins reinforce positive change and support ongoing implementation of skills. Evidence supports a 6-session format in low-resource settings. Individual sessions will begin within 2 weeks after the baseline survey and be completed by the 4-month assessment. Maintenance check-ins will begin following the 4-month assessment.
15758019|NCT04793217|Behavioral|Adapted Problem-Solving Therapy|Participants will receive three weekly individual sessions of adapted PST. The goal of PST is to identify problems that interfere with daily activities and address them through problem-orientation work. We anticipate stressors will include (a) relationship difficulties, including family stress, (b) financial stress and unemployment, (c) general impact of HIV infection, and (d) overall chronic stress. Thus, PST may indirectly address stressors that may impact care engagement, but will not address the intersection of HIV and trauma specifically.
15758020|NCT04793204|Drug|fezolinetant|oral
15758021|NCT04793178|Device|Oxygen Reserve Index, Masimo Corporation, USA.|The oxygen reserve index (ORI) is a new feature of multiple wavelength pulse oximetry that provides real-time visibility to oxygenation status in the moderate hyperoxic range (PaO2 of approximately 100-200 mm Hg).
15758022|NCT04793165|Device|Non-hybrid closed-loop system with ARG algorithm|To assess efficacy and safety of non-Hybrid Closed-loop System, without CHO counting
15758023|NCT04793152|Drug|Vancomycin|Administration as outlined
15758024|NCT04793139|Drug|Camrelizumab|Camrelizumab-treated advanced NSCLC Patients with advanced non-small cell lung cancer treated with camrelizumab. Dosage form, dosage, frequency and duration of camrelizumab is determined according to the investigator's actual clinical practice.
15758025|NCT04793126|Diagnostic Test|Urodynamic study|comparison between the urodynamic study of the patients before pelvic prolapse surgical repair and 6 months later.
15758026|NCT04793113|Other|FreshlyFit Meals|FreshlyFit meals are low carbohydrate, high protein meals
15758029|NCT04793087|Diagnostic Test|Magnetic Resonance Imaging|Comparing 3D T1 versus coronal T1 MRI in detecting Optic Neuritis
15758030|NCT04793074|Combination Product|Transforming nanoparticle dressing|Transforming nanoparticle dressing
15758031|NCT04793074|Combination Product|Conventional compression dressing|Conventional compression dressing
15758032|NCT04793061|Other|blood sample collection|Blood is samples from peripheral vein during routine care
15758033|NCT04793048|Device|a noninvasive intraoral electrotherapy device|a noninvasive intraoral electrotherapy device to treat periodontal disease at-home for 20 minutes a day
15758034|NCT04793048|Device|a sham device|a sham device to be used at-home for 20 minutes a day
15758035|NCT04793035|Device|Omega-Cuff|An omega-shaped nitinol device to be placed and secured on the Lower Esophageal Sphincter area
15758036|NCT04793022|Drug|TIVA with Propofol|Total intravenous anesthesia with propofol
15758037|NCT04793022|Drug|Inhaled Anesthesia|General anesthesia given with inhaled anesthetics
15758038|NCT04793009|Device|funnel-shaped, intraperitoneal mesh placement|Implantation of a prophylactic, 3D funnel-shaped, intraperitoneal, non-absorbable and synthetic mesh (Dyna Mesh IPST 2x15x15 cm™ and 3x16x16 cm™, FEG Textiltechnik, Aachen, Germany,)
15758039|NCT04792996|Other|No intervention|No intervention. case - control design.
15758040|NCT04792983|Other|No intervention|This is an observational study with no interventions.
15758041|NCT04792970|Drug|Talc|All patients randomized to the Talc arm will receive Talc therapy through the pleural catheter.
15758042|NCT04792957|Diagnostic Test|immunohistochemical methods|The following immunohistochemical stains will be used to evaluate the expression of JAK/STAT pathway: JAK1, JAK2, JAK3, Tyrosine Kinase 2, STAT1, STAT2, STAT3, STAT3, STAT4, STAT5 and STAT6. Staining intensity will be recorded categorically (negative and positive). The positive staining will also be graded semi-quantitively as follows: mildly positive, moderately positive and strongly positive.
15758043|NCT04792944|Drug|Urokinase|Washing the subarachnoid clot induced by a subarachnoid haemorrhage aneurysmal bleeding with urokinase after aneurysm clipping
15758044|NCT04792944|Procedure|Endovascular treatment|Aneurysm treatment through endovascular methods
15758045|NCT04792944|Procedure|Clipping|Surgical clipping of brain aneurysms
15758046|NCT04792944|Procedure|External ventricular drain|Insertion of an external ventricular drain to treat acute hydrocephalus
15758047|NCT04792931|Other|description of adult autoimmune myopathies|description of adult autoimmune myopathies
15758048|NCT04792905|Device|Cardiologs|Two Apple Watch recordings (one recording with the watch on the wrist and one on the left side of the abdomen) interpreted by Cardiologs AI done simultaneously with each 12-lead ECG
15758285|NCT04790877|Other|Sub-study 1|Subjects were provided with: a) Glucose beverage; b) Regular alcohol-free beer; c) Alcohol-free beer with modified composition (isomaltulose + maltodextrin); d) Alcohol-free beer with modified composition (++ maltodextrin).
15758543|NCT04788810|Other|Administration of d12-Cl2BPA|Administration of d12-Cl2BPA
15758050|NCT04792879|Diagnostic Test|Peripheral veins Doppler ultrasound|Patients undergoing a right heart catheterization for PH diagnosis or annual follow-up in the cardiological unit of the university hospital of Poitiers will be included. A venous Doppler ultrasound will be performed by a vascular physician, with experience in vascular ultrasound imaging, within 4 hours before the right heart catheterization. Morphological parameters of vena cava, and velocimetric parameters of femoral, jugular and supra-hepatic veins will be assessed in order to study their correlation with right auricular pressure value.
15758051|NCT04792866|Diagnostic Test|Magnetic Resonance Imaging|Comparing 3D FLAIR versus Coronal T2-WI MRI in detecting Optic Neuritis
15758052|NCT04792853|Behavioral|Tab-G|Participants receive a tablet preloaded with Tab-G application and an accelerometer.
15758053|NCT04792853|Behavioral|Tab-I|Participants receive a tablet preloaded with Tab-I application and an accelerometer.
15758054|NCT04792840|Drug|Femara Pill|study effect on bone
15758055|NCT04792801|Radiation|PET TDM FDG-Choline|Performing an FDG TDM PET and a Choline TDM PET at two different times
15758057|NCT04792775|Behavioral|PE+ER|PE includes the following components: a) psychoeducation about the common reactions to traumatic events and presentation of the treatment rationale b) repeated in vivo exposure to traumatic stimuli, c) repeated, prolonged, imaginal exposure to traumatic memories, and d) relapse prevention strategies and further treatment planning (session 12). DBT Emotion Regulation Skills is integrated as part of this intervention. DBT training provides skills to understand, name, experience and tolerate emotions, as well as skills to change negative emotional responses and to reduce vulnerability to emotion dysregulation (Linehan et al., 2015). The current project includes an adapted 3- session individual emotion regulation skills training intervention to be implemented concurrently with PE which consists of initial teaching/instruction and brief skills review for the remainder of PE treatment.
15758058|NCT04792762|Other|GIP(1-30)NH2|Intravenous administration of the peptide hormone GIP(1-30)NH2 during a stepwise glucose clamp
15758059|NCT04792762|Other|GIP(1-42)|Intravenous administration of the peptide hormone GIP(1-42) during a stepwise glucose clamp
15758060|NCT04792762|Other|Saline|Intravenous administration of saline during a stepwise glucose clamp
15758061|NCT04792749|Drug|Metformin|Patients are given 750, 1500, and 2000 mgs of metformin per os daily (dose increases weekly, then maintain at 2000 mgs) in addition to 500 mgs of medroxyprogesterone acetate per os daily and levonorgestrel-releasing intrauterine device for the treatment of early stage endometrial cancer.
15758062|NCT04792736|Diagnostic Test|Blood lactate level|Blood lactate level measured at admission H0, every 6 hours during the first 24 h and at H48
15758063|NCT04792723|Drug|Sublingual aspirin|Vita Green Health Products sublingual aspirin 80 mg tablet
15758064|NCT04792723|Drug|Oral aspirin|Synco (HK) oral aspirin 80mg tablet
15758065|NCT04792710|Drug|Metronidazole|Metronidazole 500 mg intravenous stat dose prior to skin incision
15758066|NCT04792697|Other|Increase morning bright light|Participants will wear Re-Timer bright glasses for 30 minutes each morning upon rising
15758067|NCT04792697|Other|Decrease evening blue light|Participants will wear blue light blocker goggles for 2 hours before bed
15758068|NCT04792697|Behavioral|Sleep Scheduling|Participants will advance their bedtime by 1.5 hours and regularize their wake time
15758069|NCT04792697|Behavioral|Monitor sleep, mood, and substance use|Participants will complete smartphone-based sleep, mood, and substance use monitoring
15758070|NCT04792684|Diagnostic Test|Optimization of Plasma Circulating Free-DNA (cfDNA) Marker Panel|Evaluate the performance of a preliminary panel of biomarkers
15758071|NCT04792671|Behavioral|Sociodemographic variables|age, residence, education of the mother and her husband, occupation of the mother and her husband, parity, gender, and age of the last baby.
15758072|NCT04792671|Behavioral|Family affluence scale (FAS)|a four-item measure of family wealth, has been developed in the WHO Health Behaviour in School-aged Children Study as an alternative measure.
15758073|NCT04792671|Behavioral|Edinburgh postnatal depression scale (EPDS)|s a questionnaire originally developed to assist in identifying possible symptoms of depression in the postnatal period. It also has adequate sensitivity and specificity to identify depressive symptoms in the antenatal period and is useful in identifying symptoms of anxiety. more than 9 is clinically diagnosed
15758074|NCT04792671|Behavioral|"Symptom Checklist 90 SCL 90:"|is a 90-item questionnaire used to assess psychological problems. It is designed to evaluate a broad range of psychological problems and symptoms of psychopathology. More than 60 is considered clinically diagnosed
15758075|NCT04792658|Behavioral|Detailed interview with personal demographic data|, such as age, sex, education, history of occupation, past medical history, family history, medical, neurological, and psychiatric disorders.
15758076|NCT04792658|Behavioral|Intelligence assessment using the Arabic version of the Wechsler Adult Intelligence Scale (WAIS)|the test consists of six verbal subtests and five performance subtests. It used in measure Intelligence
15758077|NCT04792658|Behavioral|The Arabic version of the Structured Interview for the Five-Factor Personality Model (SIFFM)|it depend on a model of general language personality descriptors that based on theory suggests five broad dimensions to describe human personality
15758078|NCT04792658|Behavioral|the Hamilton Depression Rating Scale|it used for evaluation depression severity. It is 17 items and each item's score (0-4). with a total score range of 0-54
15758079|NCT04792658|Behavioral|The Hamilton Anxiety Rating Scale|it used for evaluation the severity of anxiety. The scale consists of 14 items and each item is scored on a scale from 0 to 4 , with a total score range of 0-56
15758080|NCT04792658|Behavioral|The Minnesota Multiphasic Personality Inventory-2 (MMPI-2)|It used to evaluate range of symptoms of psychopathology and personality traits that are maladaptive. It has 10 clinical scales subscales included the following: 1, hypochondriasis (Hs); 2, depression (D); 3, hysteria (Hy); 4, psychopathic deviation (Pd); 5, masculinity-femininity (Mf); 6, paranoia (Pa); 7, psychophrenia (Pt); 8, schizophrenia (Sc); 9, hypomania (Ma); 10, social introversion (Ma); (Si). More than 65 responses were considered symptomatic
15758081|NCT04792645|Drug|Placebo|Pill that contains no medicine
15758082|NCT04792645|Drug|Memantine|Cognition-enhancing medication
15758083|NCT04792632|Device|Veye Lung nodules|Veye Lung Nodules
15758084|NCT04792619|Other|Bobath Approach|The patients in both groups were treated with the exercise program according to the Bobath concept was planned taking the functional needs of the survivors into account, including stretching and facilitation of latissimus dorsi muscle, facilitation of abdominal muscles, placing exercises, training of lumbar spine stabilizers, functional reach of shoulder in different directions. Five sessions of about an hour each were provided to the patients
15758085|NCT04792619|Other|Isometric scapular exercises|Isometric scapular exercises were performed to the patients included to the study group in a sitting position and at 900 of the shoulder flexion and 900 of the shoulder abduction. The patients were exercised by a physiotherapist using isometric contraction in protraction and retraction by a physiotherapist. Isometric contractions lasted 5 seconds and each exercise was repeated 2x15 times. One minute rest period was given between sets
15758086|NCT04792593|Biological|Senl-h19 CAR-T|Biological: Senl-h19 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis
15758087|NCT04792580|Drug|Lifitegrast 5% Ophthalmic Solution|Used twice a day in both eyes for 4 weeks after a 2 week washout.
15758088|NCT04792580|Drug|Refresh|Used twice a day in both eyes for 4 weeks after a 2 week washout with the same drops.
15758089|NCT04792567|Drug|BAF312|taken orally once per day (dose depends on CYP2C9 genotype)
15758090|NCT04792567|Drug|Baseline disease modifying therapies (DMTs)|DMTs: Dimethylfumarate, glatirameracetate, interferon, teriflunomode according to respective SmPC
15758091|NCT04792554|Other|Neurocognitive tests and blood taking|Battery of neurocognitive tests and questionnaires including MoCA, PHQ-9, Falls History, FIFE, STOPBANG, Nutritional Survey, Global Physical Activity Questionnaire, Brief Pain Index, Brief Psychiatric Rating Scale, NuDESC, 3D-CAM. Blood taking.
15758092|NCT04792541|Other|HY containing gel; GUM® Afta Clear Gel, Sunstar|
15758093|NCT04792541|Other|saline solution|
15758094|NCT04792528|Other|Computerized cognitive training.|COGMED RM program (Pearson Inc., UK)
15758095|NCT04792528|Other|Generalized brain training / Active control|Solitaire
15758096|NCT04792515|Drug|Camrelizumab combined with SOX/ or apatinib|"Camrelizumab: every 3 weeks (21 days) was given as one administration cycle. 200mg was given intravenously on the first day of each cycle. Dose adjustment is not allowed. Delayed administration is allowed.
~Apatinib mesylate: 250mg, qd, stopped 28 days before surgery, and can be used by the investigator according to the patient's recovery 28 days after surgery.
~Chemotherapy: The SOX regimen consisted of one cycle every 3 weeks (21 days).Dose adjustment is allowed. Delayed administration is allowed.
~Oxaliplatin (OXA) : 130mg/m2, intravenous infusion, d1, infusion more than 2 hours.
~Tigio Capsules (S-1) : Take orally after breakfast and dinner, twice daily, d1-14.
~The dosing time window is ±3 days, but within 72 hours before each dosing, subjects must complete an examination that includes all clinical requirements to assess tolerance for continued dosing."
15758097|NCT04792502|Drug|Mosunetuzumab|Administered subcutaneously by injection beginning with 5 mg and increasing to 45 mg.
15758098|NCT04792502|Drug|Lenalidomide|Patients in the augmentation cohort will be dosed continuously, 10 mg orally once daily, with or without food.
15758099|NCT04792489|Biological|MB-CART2019.1|Chimeric antigen receptor (CAR) T cell therapy
15758100|NCT04792476|Other|High Intensity Interval Training|Experimental group will receive, in addition to the conventional treatment, a physical exercise intervention along 12 weeks, which will consist of complying with the general recommendations for physical activity: 75 minutes weekly of high intensity physical exercise. The therapeutic exercise intervention will be supervised by a physiotherapist and designed in a progressive, structured and personalized way.
15758101|NCT04792450|Device|Thermography|Measure Temperature using Thermal Camera
15758102|NCT04792450|Device|Tympanic Thermometer|Measure Temperature using Tympanic Thermometer
15758103|NCT04792450|Device|Forehead Thermometer|Measure Temperature using Forehead Temperature
15758104|NCT04792450|Device|62 Max + Infra-red thermometer|Measure Temperature using 62 Max + Infra-red thermometer
15758105|NCT04792437|Procedure|surgery|surgery
15758106|NCT04792424|Other|Regional citrate anticoagulation|Starting RCA 4 mmol/L (adjust the rate by BFR)
15758107|NCT04792424|Drug|Vasopressor|Vasopressors such as Norepinephrine, dopamine, milrinone, dobutamine
15758108|NCT04792424|Drug|Antibiotic|Antibacterial agents deemed appropriate by physicians in the ICU
15758109|NCT04792424|Device|Dialysis with continuous renal replacement therapy|Prismaflex
15758110|NCT04792411|Behavioral|Prehabilitation|Multimodal, tailored prehabilitation programme
15758111|NCT04792398|Drug|Incobotulinumtoxin A (BTX A) Xeomin®|Injections into the masseter muscles bilaterally (25 Units per muscle applied with 2 injections in each muscle)
15758112|NCT04792385|Drug|E4/DRSP 15/3 mg combined tablet|One E4/DRSP 15/3 mg combined tablet once per day for 24 days followed by 4 days of placebo tablets; this 28-day cyclic regimen should be taken for 6 consecutive cycles.
15758113|NCT04792372|Procedure|Initial periodontal treatment|Conventional periodontal treatment (scaling and root debridement) will be conducted
15758114|NCT04792359|Device|Equinometer|Measurement of dorsiflexion of the ankle will be reproduced three times on each ankle in two positions, with a force applied
15758115|NCT04792346|Radiation|breast/chest wall radiotherapy|34 Gy/10 fxs/2 wks to the whole breast/chest wall and locoregional lymph nodes; an optional single fraction 8 Gy boost was administered with electrons to the tumor bed in patients undergoing conservative surgery
15758116|NCT04792333|Drug|firibastat|Single oral dose of 500 mg administration on Day 1
15758117|NCT04792320|Dietary Supplement|Active bamboo charcoal|4g particle
15758118|NCT04792320|Dietary Supplement|probiotics|0.8g powder
15758139|NCT04792125|Behavioral|External electrical stimulation (EES) added to pelvic floor muscle training (PFMT)|"Patients will be treated with the Innovo device using eight external electrodes with a combined stimulator. Electrodes will be applied to the buttocks, outer hips and anterior and posterior proximal thighs 3 days a week for 30 minutes each session.
~While explaining the exercise to the patients, it was stated that 1 set of exercise consisted of 10 fast contractions and 10 slow contractions. For the first 2 weeks, they were asked to exercise 2 sets a day, every day. Thus, in the first 2 weeks, 20 fast contractions and 20 slow contractions were performed. Then, 2 sets were increased every two weeks and the exercise was ended as 8 sets (80 fast and 80 slow contractions) at the end of the 8th week."
15758544|NCT04788797|Drug|Prolyl Endopeptidase|Two capsules three times a day.
15758119|NCT04792307|Other|Neuromuscular electrical stimulation , no high protein ice cream supplementation|"A trained operator applies Neuromuscular electrical stimulation treatment to one leg, for approximately 30 minutes per session, three sessions per week with or without high protein ice cream. Treatment can stimulate the nerve controlling the vastus lateralis muscle in the thigh or the nerve controlling the tibialis anterior muscle in the lower leg, or both. In our study, we will aim to stimulate both nerves and muscle groups, on the basis that the maximal effect with result from the maximal amount of muscle stimulated.Treatment is adjusted to generate a specific force and maintained for up to 5 minutes, followed by a rest period and then repeated three times over the typical 30-minute session. The stimulation can vary according to the frequency (pulses per second, typically 10-50Hz).
~Additional protein supplementation: high protein ice cream :a single doses of a high protein supplement after each bout of neuromuscular electrical stimulation,"
15758120|NCT04792294|Device|Extracorporeal photopheresis|ECP can be used as second-line treatment in patients unresponsive to azithromycin. ECP has been firstly developed for treatment of cutaneous T cell lymphomas and later used in a variety of other indications including solid organ transplantation. The process starts with leukapheresis, followed by incubation of the isolated cells with 8-methoxypsoralen (8-MOP) and subsequent activation of 8-MOP with ultraviolet A radiation. At the end, the cells are reinfused into the patient. 8-MOP is a biologically inert substance, but in the presence of UVA light it cross-links DNA by forming covalent bonds with pyrimidine bases and causes apoptosis.
15758121|NCT04792268|Other|Access to eCDSS on wards|"Electronic clinical decision support (eCDSS) will be available to clinicians on wards recruited to this arm.
~An eCDSS is a health information technology system designed to assist clinicians and other health care professionals in clinical decision-making.
~The key digital tool to be used for eCDSS in this study is CogStack. This eCDSS has been developed to alert clinicians automatically regarding patients admitted under their care, triggered by the presence of new, old or absent HbA1c pathology reports on the electronic health record (EHR)."
15758122|NCT04792255|Procedure|Carotid artery stenting with standard contrast media protocol|Radial, brachial or femoral arterial access is gained by using the Seldinger technique. The common carotid artery (CCA) is catheterized. Selective angiography is performed from the anteroposterior and lateral view without magnification. Initial angiograms are performed with standard contrast media protocol in anteroposterior and lateral views without magnification with the sheath placed in the common carotid artery. The carotid arterial lesion is crossed and an embolic protection device is deployed in the internal carotid artery. Carotid artery stenting is performed in a standard fashion. Post-stenting angiographies are obtained with the standard contrast media protocol in anteroposterior and lateral views without magnification with the sheath placed in the CCA. Pre- and post-stenting angiographies are performed with the same sheath position. DSA and DVA images will be calculated on a commercially available image processing workstation and the Kinepict Medical Imaging Tool.
15758123|NCT04792255|Procedure|Carotid artery stenting with reduced contrast media protocol|Radial, brachial or femoral arterial access is gained by using the Seldinger technique. The common carotid artery (CCA) is catheterized. Selective angiography is performed from the anteroposterior and lateral view without magnification. Initial angiograms are performed with the reduced contrast media protocol in anteroposterior and lateral views without magnification with the sheath placed in the common carotid artery. The carotid arterial lesion is crossed and an embolic protection device is deployed in the internal carotid artery. Carotid artery stenting is performed in a standard fashion. Post-stenting angiographies are obtained with the reduced contrast media protocol in anteroposterior and lateral views without magnification with the sheath placed in the CCA. Pre- and post-stenting angiographies are performed with the same sheath position. DSA and DVA images will be calculated on a commercially available image processing workstation and the Kinepict Medical Imaging Tool.
15758124|NCT04792255|Diagnostic Test|Carotid Duplex Ultrasound|Pre- and postinterventional assessment of the treated internal carotid artery.
15758125|NCT04792242|Device|cv line insertion|Svo2 and central venous pressure measurements
15758126|NCT04792242|Device|Urinary catheter insertion|urine output measurement
15758127|NCT04792242|Device|Arterial line|Arterial blood gases measurment
15758128|NCT04792229|Other|Whole Body Viberation|WBV device (frequency of 40 Hz), 3 Minute vibration with 3 minute rest
15758129|NCT04792216|Other|Wild Salmon|Wild salmon fillets
15758130|NCT04792216|Other|Farmed Salmon|Farm salmon fillets
15758131|NCT04792190|Drug|dapagliflozin|Subjects will take 1 blinded tablet of study drug (dapagliflozin 10 mg) dosed once daily, for 12 months.
15758132|NCT04792190|Drug|Placebo|Subjects will take 1 blinded capsule of placebo drug dosed once daily
15758133|NCT04792177|Behavioral|Emotion regulation skills training|The intervention will involve an online emotion-regulation skills training for individuals with sexual problems. It will last for 8 weeks, encompassing psycho-educational and emotion-regulation skills components. Every week participants will gain access to a different intervention module of the training, containing videos, presentation slides, written support material and a recommendation of activities to be completed until the following week of training. Participants are expected to dedicate 30 minutes to one hour per week to complete each module.
15758134|NCT04792164|Procedure|Ultra sound guided nerve block|Ultra sound guided nerve block by lidocaine before open inguinal hernia repair.
15758135|NCT04792164|Procedure|Usual infiltration|Usual infiltration by lidocaine before open inguinal hernia repair.
15758136|NCT04792151|Behavioral|Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents|The Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C and UP-A) are transdiagnostic, behavioral interventions for youth with emotional disorders, including anxiety, depression, obsessive-compulsive disorders, and irritability.
15758137|NCT04792138|Diagnostic Test|VERDICT MRI|Advanced Diffusion Model
15758138|NCT04792138|Diagnostic Test|Luminal Index Imaging|Advanced T2 mapping
15758140|NCT04792125|Behavioral|External electrical stimulation|Patients will be treated with the Innovo device using eight external electrodes with a combined stimulator. Electrodes will be applied to the buttocks, outer hips and anterior and posterior proximal thighs 3 days a week for 30 minutes each session.
15758286|NCT04790877|Other|Sub-study 2|Subjects were provided with: a) White bread + Water; b) White bread + Regular alcohol-free beer; c) White bread+Alcohol-free beer enriched with isomaltulose+maltodextrin); d) White bread + Alcohol-free beer enriched with ++ maltodextrin; e) Extra-White bread + Water.
15758141|NCT04792125|Behavioral|Pelvic floor muscle training (PFMT)|While explaining the exercise to the patients, it was stated that 1 set of exercise consisted of 10 fast contractions and 10 slow contractions. For the first 2 weeks, they were asked to exercise 2 sets a day, every day. Thus, in the first 2 weeks, 20 fast contractions and 20 slow contractions were performed. Then, 2 sets were increased every two weeks and the exercise was ended as 8 sets (80 fast and 80 slow contractions) at the end of the 8th week.
15758142|NCT04792112|Behavioral|Decision support tool|Decision support tool for late preterm antenatal corticosteroids
15758143|NCT04792099|Procedure|Continuous positive airway pressure|After study entry, CPAP will be provided via mask or binasal prongs in order to have a relatively uniform CPAP delivery system among infants in the treatment group. Bubble CPAP will be preferred over other modes of CPAP delivery. A PEEP of 5 will be used for uniformity.
15758144|NCT04792099|Procedure|Nasal Cannula|After study entry, flow will be set to 0.5 L/kg with 1L maximum while on NC during the study period to reduce the risk of inadvertent PEEP with higher flows. Initial FiO2 can be titrated to achieve target saturations, and may be increased up to 100% while on NC.
15758145|NCT04792073|Drug|Avelumab|Avelumab 800 mg given intravenously over 60 minutes every 2 weeks (+/- 3 days)
15758146|NCT04792073|Radiation|Comprehensive Ablative Radiation Therapy|Comprehensive ablative radiation therapy 24 Gy in 3 fractions every 2-3 days
15758147|NCT04792060|Procedure|Hook plate|We used titanium 2.4 mm hooked distal ulnar locked plate used for fixation of distal ulna fractures , this plate have low profile which is anatomically precontoured
15758148|NCT04792047|Diagnostic Test|HRP frequency, plaque compostion and local immune-inflammatory activation|HRP frequency, plaque compostion were detected by CCTA method. Local T cell subsets and their intracellular cytokines levels were detected by Flow Cytometry.
15758149|NCT04792034|Drug|Cocaine Hydrochloride Topical Solution|Topical Anesthetic
15758150|NCT04792021|Drug|N-acetylcysteine|Oral formulation: 600 mg sachets of N-acetylcysteine
15758151|NCT04792008|Biological|YQ23|Single dose of 120 mg/kg YQ23 via intravenous route will be evaluated
15758152|NCT04792008|Biological|Matching placebo|Single dose of 0.9% normal saline via intravenous route as matching placebo
15758153|NCT04791982|Behavioral|Educational sessions|Firstly, the literature was scanned and a education booklet prepared after the opinions of 5 academic nurses, who are experts in the field of oncology, was used. The booklet was included colorectal cancer treatment, symptoms that may develop due to chemotherapy and information on their control, psychosocial support of caregiving family members. Interviews and educational sessions with family members who agreed to participate in the study were held in one-on-one and face-to-face meeting room. These interviews lasted approximately 45 to 60 minutes for each family member. In the interviews, a educational booklet containing information on nutrition, exercise, symptom management, physical aspects of care and disease-specific care was used to present information to caregivers. All of educational sessions were performed by the single researcher.
15758154|NCT04791969|Drug|Naltrexone Hydrochloride|Intermittent Oral Naltrexone, 50 mg
15758155|NCT04791969|Drug|Placebo|Intermittent Oral Placebo
15758156|NCT04791969|Behavioral|Ecological Momentary Intervention|"Receive ecological momentary intervention if ecological momentary assessment reports meth craving, stress, not taking study drug, or antecedents detected for high risk meth use."
15758157|NCT04791956|Dietary Supplement|Prebiotic|Daily intake of Inulin-type fructans from chicory
15758158|NCT04791956|Dietary Supplement|Placebo|Daily intake of maltodextrin
15758159|NCT04791943|Drug|Melatonin 10 MG|3 melatonin 10mg capsules will be given to the treatment arm
15758160|NCT04791943|Drug|Lactose pill|3 lactose pills will be provided to the control arm
15758161|NCT04791917|Behavioral|Eccentric Biceps Flexion|Muscle lengthening biceps exercise
15758162|NCT04791917|Behavioral|Concentric Biceps Flexion|Muscle shortening biceps exercise
15758163|NCT04791878|Drug|Mesenchymal stem cells|Direct injection of 75 million allogeneic bone marrow derived mesenchymal stem cells at baseline and again after 3 months if not completely healed
15758164|NCT04791865|Behavioral|Disclosure intervention|Participants who are assigned to the Sankofa intervention will take part in the process of disclosure (pre-disclosure, disclosure, and post-disclosure phases) with the adherence and disclosure specialist (ADDS).
15758165|NCT04791865|Behavioral|Usual Care|During the control period, patients and caregivers recruited at the clinics will receive the current practice in the clinic, where the health care provider is expected to assess the caregiver and child readiness for disclosure during clinic appointments and give some information as they think indicated.
15758166|NCT04791852|Diagnostic Test|Donor-derived Cell Free DNA|We will compare ddcfDNA with coronary angiogram determined CAV grading, according to ISHTL2010 classification
15758167|NCT04791839|Drug|Zimberelimab|Zimberelimab will be supplied by Arcus Biosciences.
15758168|NCT04791839|Drug|Domvanalimab|Domvanalimab will be supplied by Arcus Biosciences.
15758169|NCT04791839|Drug|Etrumadenant|Etrumadenant will be supplied by Arcus Biosciences.
15758170|NCT04791826|Behavioral|On-screen electronic alert|On-screen computer-based alert notifying the provider that the patient is at an increased risk of developing HF based on the WATCH-DM risk score and associated guideline recommendation for preventive management of these patients.
15758171|NCT04791813|Other|Alginate impressions , Photographic data and panoramic radiographs .|Upper and lower alginate impressions will be poured and dental casts produced and converted to 3D digital cast using a 3D scanner-(3Shape )-the 3D data will be imported to a revers modeling software . Also Photographic data using Canon750 camera and panoramic radiographs to be taken.
15758172|NCT04791800|Diagnostic Test|Malaria/CRP combination test|Testing with a malaria/CRP combination test, in parallel with a standard malaria RDT (to guide case management), preparation of thin/thick films for expert malaria microscopy, and collection of venous blood for subsequent CRP quantification.
15758173|NCT04791787|Other|Standard weight maintaining diet|Diet containing diet approximately 25-35% protein, 45-55% carbohydrate, 20- 30% fat
15758174|NCT04791787|Other|Weight maintaining isocaloric ketogenic diet|Isocaloric ketogenic diet containing approximately 15-25% protein, 5-10% carbohydrate,70- 80% fat
15758175|NCT04791787|Dietary Supplement|Beta-hydroxy butyrate|A supplement of ketone ester of beta-hydroxy butyrate
15758176|NCT04791774|Dietary Supplement|Milk protein (food grade protein)|Subjects will receive an enteral nutritional formula containing 20 grams intrinsically labeled (1-[13C]-phenylalanine) milk protein
15758178|NCT04791761|Drug|Oxycodone|Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations. Subjects or parents will purchase this medication and dosage will be given to subjects in easy-to-understand language.
15758179|NCT04791761|Drug|Ibuprofen|Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses. It will be prescribed in liquid suspension form for ease of use in pediatric populations. Subjects or parents will purchase this medication and dosage will be given to subjects in easy-to-understand language.
15758180|NCT04791761|Drug|Acetaminophen|Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours. It will be prescribed in liquid suspension form for ease of use in pediatric populations. Subjects or parents will purchase this medication and dosage will be given to subjects in easy-to-understand language.
15758181|NCT04791761|Other|Opioid disposal pouch|Half of the opioid group will be randomized assigned to an opioid disposal pouch arm. This pouch is a drug deactivation system that can be disposed in the trash in a household.
15758182|NCT04791761|Other|Opioid disposal education|An opioid disposal education document will be provided to all families in the opioid group. This education document has information on unused or expired prescription medication disposal and specific information about permanent collection sites within our health system, drug take-back locations, drug take back day, and disposing at home.
15758183|NCT04791748|Diagnostic Test|Vestibular tests|Screening vestibular test for patients without chronic vestibular deficits Complete vestibular test if not done yet in care of patients with chronic vestibular deficits
15758184|NCT04791748|Other|Virtual reality|Virtual reality protocol : doing tasks involving hand-eye coordination, in virtual reality, and in different sensory situations
15758187|NCT04791722|Behavioral|Adaptive Intervention|The investigators will conduct an adaptive intervention using six key implementation strategies identified in earlier research on the experiences of public housing authorities adopting a smoke-free housing policy: resident engagement, smoking cessation support, smoker compliance strategies, smoke-free policy enforcement, staff training and community partnership development. The implementation approach will be tailored for each property by varying the order and intensity of smoke-free policy implementation approaches. The design will determine the optimal plan for utilizing the six implementation strategies by learning from the challenges and successes of other properties (previous waves) and providing support to property managers to refine an implementation plan.
15758188|NCT04791709|Behavioral|Happy Older Latinos are Active (HOLA)|HOLA is a multicomponent health promotion intervention. First component is a one-on-one social and physical activation with the participant and the community health worker (CHW). Each session will last approximately 30 minutes at day 1 and week 8. The second component is a group walk led by a CHW for 45 minutes, 3 times a week, for 16 weeks. The third component consists of scheduling pleasant events at the end of each group walk session.
15758189|NCT04791683|Other|sexaul counseling|Sexual counseling includes interviews about sexual problems in couples who are in the process of infertility treatment and suggestions for solving these problems.
15758190|NCT04791670|Other|survey study|The surveys will include general data, the type of electronic devices in possession and the purpose of use. eHealth literacy will be assessed with the eHeals questionnaire. Platform's ease of use will be assessed with the System Usability Scale, and participants´ opinion about the digital path utility with six questions. These items will be answered with a Likert-scale. Finally, we added an open question for qualitative analysis.
15758191|NCT04791657|Procedure|Appendectomy|Surgical treatment for appendicitis
15758192|NCT04791631|Procedure|Epiretinal membrane surgery|Surgery for epiretinal membrane i.e. standard 3-port pars plana vitrectomy and epiretinal membrane and internal limiting membrane peel. Phakic patients will undergo cataract surgery.
15758193|NCT04791618|Behavioral|Health360x plus health coach|Access to health360x which provides monitoring, in the moment color coded feedback and goal setting for self management skills
15758194|NCT04791618|Behavioral|Health360x only (High tech)|All participants will have access to Helath360x with reminders generated for goal setting.
15758195|NCT04791605|Other|Gait analysis|Kinematic and kinetic analysis
15758335|NCT04790552|Other|Bar with Tea|Subjects will be asked to consume a Fast Bar with tea.
15758336|NCT04790539|Drug|SHR-1210|SHR-1210 is a humanized anti-PD-1 IgG4 monoclonal antibody
15758504|NCT04789161|Procedure|double kissing crush stenting|Patients with true bifurcation lesion treating with double kissing crsuh stenting technique
15758505|NCT04789161|Procedure|double kissing culotte stenting|Patients with true bifurcation lesion treating with double kissing culotte stenting technique
15758196|NCT04791592|Procedure|Single-injection, ultrasound-guided bilateral PIF block.|"PIF block bilaterally (20 ml, 0.25% bupivacaine + 1:400.000 adrenaline). In addition, LA infiltration (10 ml, 0.25% bupivacaine) will be performed by the surgeon around the chest tube in all patients.
~Intraoperative analgesia: At the end of the surgery, all patients will be given 0.05 mg/kg morphine IV.
~Postoperative analgesia: Paracetamol 1 gr IV (every 6 hours) and IV PCA of 0.5 mg/ml morphine (demand dose 20µg/kg; lock out interval 6-10 min.; the 4-hour limit will be 80% of the total calculated dose).
~In cases where rescue analgesia is required (NRS score ≥4) tramadol 100 mg IV will be infused within 30 minutes (max. 300 mg / day).
~For postoperative nausea and vomiting prophylaxis, patients will be routinely administered ondansetron 4 mg IV 20 minutes before extubation in the intensive care unit."
15758197|NCT04791592|Procedure|Single-injection, ultrasound-guided bilateral TTMP block.|"TTMP block bilaterally (20 ml, 0.25% bupivacaine + 1:400.000 adrenaline). In addition, LA infiltration (10 ml, 0.25% bupivacaine) will be performed by the surgeon around the chest tube in all patients.
~Intraoperative analgesia: At the end of the surgery, all patients will be given 0.05 mg/kg morphine IV.
~Postoperative analgesia: Paracetamol 1 gr IV (every 6 hours) and IV PCA of 0.5 mg/ml morphine (demand dose 20µg/kg; lock out interval 6-10 min.; the 4-hour limit will be 80% of the total calculated dose).
~In cases where rescue analgesia is required (NRS score ≥4) tramadol 100 mg IV will be infused within 30 minutes (max. 300 mg / day).
~For postoperative nausea and vomiting prophylaxis, patients will be routinely administered ondansetron 4 mg IV 20 minutes before extubation in the intensive care unit."
15758198|NCT04791579|Drug|Ciprofloxacin|Fluoroquinolone antibiotic
15758199|NCT04791579|Drug|Placebo|Placebo pill
15758200|NCT04791566|Drug|Dexamethasone 1 mg/kg|Dexamethasone 1 mg/kg administered as a single preoperative i.v. infusion over 10-15 min prior to general anaesthesia
15758201|NCT04791566|Drug|Physiologic saline|100 mL Physiologic saline administered as a single preoperative i.v., infusion over 10-15 min prior to general anaesthesia
15758202|NCT04791553|Drug|Cenobamate|Cenobamate (YKP3089) is a small molecule approved in the United States (US) for the treatment of partial onset seizures (POS) in adult patients.
15758203|NCT04791540|Diagnostic Test|handgrip strenght|Muscle strenght measured with a handheld dynamometer, at admission (T0) and at decannulation time (T1)
15758204|NCT04791540|Diagnostic Test|Bioelectrical Impedance Analysis (BIA)|Muscle mass evaluated by Bioelectrical Impedance Analysis (BIA), at admission (T0) and at decannulation time (T1)
15758205|NCT04791540|Diagnostic Test|MUST|Malnutrition risk assessed by Malnutrition Universal Screening Tool (MUST), at admission (T0) and at decannulation time (T1)
15758206|NCT04791540|Diagnostic Test|GLIM|Malnutrition diagnosis performed by Global Leadership Initiative on Malnutrition (GLIM) criteria, at admission (T0) and at decannulation time (T1)
15758207|NCT04791540|Biological|Gut microbiota|A fecal sample obtained at admission (T0) and at decannulation time (T1)
15758208|NCT04791540|Biological|Blood Sample|A Blood sample obtained at admission (T0) and at decannulation time (T1)
15758209|NCT04791540|Other|Anthropometric measures|Measurement of weight and height (assessed only at admission) to calculate the Body Mass Index (BMI), at admission (T0) and at decannulation time (T1)
15758210|NCT04791527|Behavioral|Mind-body therapy|Online yoga, meditation, behavior change tips, and nutrition tips
15758211|NCT04791514|Drug|Treprostinil Palmitil|Administered by oral inhalation using a Plastiape capsule-based Dry Powder Inhaler
15758212|NCT04791501|Device|Mechanical ventilation|Ventilatory support
15758215|NCT04791475|Procedure|adding Dexmedetomidine and dexamethasone to bupivacaine in USG guided supraclavicular brachial plexus block.|The linear transducer probe (frequency 4 -12 Hz) of USG machine will be used. A superficial skin wheal will be made by 2ml of 1% lignocaine subcutaneously at the point of needle insertion. USG guided Brachial plexus block will be performed by supraclavicular route via the subclavian perivascular approach in in-plane technique from lateral to medial using 22 gauge spinal needle. Study Drug will be administered via Pressure Monitoring line connected to syringe according to the allocated group with repeated aspiration and incremental dosing. • Intercostobrachial nerve block will be performed to alleviate the tourniquet pain. A 25 G needle will be inserted at the level of axillary fossa. The entire width of the medial aspect of arm, starting at the deltoid prominence and proceeding inferiorly, will be infiltrated with 5ml of 1% Lignocaine with Epinephrine (1:4,00,000) to raise a subcutaneous wheal. •
15758216|NCT04791449|Other|Structured exercise program|Medically-supervised participation in 2-3 exercise sessions per week over 12-wk study period. Exercise conducted in the cardiac rehabilitation program.
15758217|NCT04791436|Diagnostic Test|Gustatory and olfactory function test|The gustatory and olfactory function will be tested by using the combined Burghart Screening 12 test containing smelling sticks and taste strips (Fa. MediSense, Groningen, Netherlands). Evaluation of taste and smell is performed by offering the sticks/strips and demand a forced multiple choice.
15758218|NCT04791436|Diagnostic Test|Molecular assessment of saliva|Saliva samples will be taken for molecular biological determination of the oral microbiome. The microbiome is determined at the Institute for Medical Microbiology by 16s-rRNA gene analysis with Next Generation Sequencing and bioinformatics.
15758219|NCT04791423|Biological|GRAd-COV2|GRAd-COV2 is a replication-defective gorilla adenoviral vector (GRAd) encoding the SARS-CoV-2 surface glycoprotein (S, Spike) antigen under the control of CMV immediate early promoter. The encoded Spike antigen is stabilized in pre-fusion conformation by introducing 2 proline residues
15758220|NCT04791423|Other|Placebo|Saline solution
15758221|NCT04791410|Procedure|microvascular decompression|Microvascular decompression of rostral ventrolateral medulla
15758246|NCT04791215|Other|Observational|All patients will be treated with standard of care pembrolizumab. After obtaining written informed consent, NSCLC participants will have serial blood collection. The blood collection (26 ml) should coincide with routine clinical blood draw to minimize participant discomfort if possible. No additional procedures will be performed other than phlebotomy. If additional biopsies or tumor resection are performed as part of routine standard of care throughout the course of the study, an additional 26 ml blood collection may be drawn for the study. Participants will remain on the study for as long as they are being followed or treated at Columbia University Irving Medical Center. Participants can withdraw from the study at any time.
15758222|NCT04791397|Procedure|Interval hypoxic-hyperoxic training (IHHT) using respiratory therapy unit ReOxy.|Every patient from control group undergo 15 procedures of IHHT, 5 procedures per week for 3 weeks, 1 procedure lasts 40 minutes. IHHT is a protocol which employs passive (the patient is at rest), short (several minutes) mild normobaric hypoxic exposures alternated with similar duration intervals of breathing hyperoxia, and repeated for 40 minutes. During the initial pretreatment test, the patient inhales air with low oxygen content at atmospheric pressure in a continuous mode through a mask. In the interval therapeutic mode that follows, periods of hypoxia (10-14% O2) are interrupted by periods of reoxygenation by hyperoxia (up to 35% O2). Automatic switching of gas flows (SRT technology). Built-in intelligent software automatically identifies and suggests key treatment parameters for the individual treatment program, by adjusting the starting parameters based upon the results of the pretreatment hypoxic test.
15758223|NCT04791397|Procedure|Simulating Interval hypoxic-hyperoxic training (IHHT) using respiratory therapy unit ReOxy.|Every patient from group control undergo simulating procedures of interval hypoxic-hyperoxic training, 15 procedures, 5 procedures per week for 3 weeks. 1 procedure lasts 40 minutes, in normoxia. Before the start of the course, each patient undergoes a test procedure for 10 minute (in normoxia) for simulate procedures IHHT.
15758224|NCT04791384|Drug|Abemaciclib|taken orally
15758225|NCT04791384|Drug|Elacestrant|taken orally
15758227|NCT04791358|Diagnostic Test|KidneyIntelX|KidneyIntelX is an in-vitro diagnostic that enables accurate risk prediction of progressive decline in kidney function and kidney failure in patients with type 2 diabetes and existing CKD at stages 1-3 (eGFR of 30 to 59 ml/min/1.73m2, or eGFR ≥ 60 ml/min/1.73m2 and uACR ≥ 30 mg/g).
15758228|NCT04791345|Drug|Methylprednisone|12 mg of methylprednisone (3 pills of 4 mg each) administered orally in a single dose.
15758229|NCT04791345|Drug|Methylprednisone|12 mg of methylprednisone (3 pills of 4 mg each) administered orally every 24 hours during 3 days.
15758230|NCT04791345|Drug|Deflazacort|30 mg of deflazacort (1 pill) administered orally in a single dose.
15758231|NCT04791345|Drug|Dexamethasone|4 mg of dexamethasone (1 pill) administered orally in a single dose.
15758232|NCT04791345|Drug|Dexamethasone|2 mg of dexamethasone (1/2 pill) administered orally every 12 hours during 5 days.
15758233|NCT04791332|Drug|JNJ-67953964|JNJ-67953964 capsule will be administered orally.
15758234|NCT04791332|Drug|Placebo|Matching placebo will be administered orally.
15758238|NCT04791306|Other|supervised exercise training|Participates perform once a week for 4 months an in-house supervised endurance and strength training.
15758239|NCT04791306|Other|home-based exercise training|Participants are provided with an application for planning and documentation of their physical activity, together with an expert participants plan their physical activities for their home-based training to reach at least 150 min physical activity per week.
15758240|NCT04791293|Other|MELD-Na score|MELD-Na scores will be compared between the groups
15758241|NCT04791280|Procedure|Faeces collection|"faeces collection at inclusion
~follow-up visit 6 months after inclusion"
15758242|NCT04791267|Behavioral|Community Health Navigator Program|Patients will be matched to a community health navigator (CHN) who will conduct a needs assessment to determine the frequency of meetings. A CHN may perform any of the following: providing information to a patient's health care provider, translation, advocating for the patient, connecting the patient with resources (e.g., social, financial, insurance), helping patients set health-related goals, facilitating health care referrals and appointments, and monitoring appointments. These activities may require the CHN to be physically present at appointments or have direct contact with the patient's health care provider. Goal setting and support will be provided in-person or over the telephone using motivational interviewing principles.
15758243|NCT04791241|Other|check-list including lung ultrasound|"The investigator will follow the checklist which includes the collection of anamnestic data and clinical signs, the performance of a pulmonary embolism clinical probability score and a cardiopulmonary ultrasound with count -standardized rendering. After completing this checklist, the investigator will note their diagnosis (list of proposals on the data collection sheet), the treatments started (closed list of therapeutic classes). If he orders other tests, he will write them down and then note the diagnosis made and the treatments prescribed after obtaining the results of these tests.
~The therapeutic management of patients compared to the usual care in the respective departments may be modified depending on the results of the cardiopulmonary ultrasound . The emergency physician may initiate therapy before the results of additional examinations that he would have usually performed without cardiopulmonary ultrasound."
15758247|NCT04791202|Drug|Dextrose|See arm descriptions
15758248|NCT04791202|Drug|Methylprednisolone Acetate 40 MG/ML|See arm descriptions
15758249|NCT04791189|Other|questionnaire|questionnaire to survey the needs of adolescents with juvenile idiopathic arthritis and the views of their parents in the area of sexual health.
15758432|NCT04789798|Other|Usual care|Usual diabetes care, as provided by primary care providers
15758250|NCT04791176|Radiation|concurrent lenvatinib and Radiotherapy, followed lenvatinib maintenance|Radiotherapy with IMRT or VMAT with 40-60Gy/20-30f; Concurrent Lenvatinib 12mg/day (for patients≥60 kg) or 8 mg/day (for patients<60kg ) qd po. (Note: Levatinib can be given to patients in four weeks before Radiotherapy is applied, so that it can control disease during waiting for Radiotherapy). Maintenance Lenvatinib 12mg/day (for patients≥60 kg) or 8 mg/day (for patients<60kg ) qd po until disease progress or unacceptable adverse events; six months is recommended but not mandatory.
15758251|NCT04791163|Device|Socket evaluation|The subject will wear the socket for 4 weeks, and then reply questionnaires and achieve a 2-minute walking test
15758252|NCT04791150|Other|Fill in a form|Patient will have to fill in a form at each perfusion of immunotherapy to tell if they presents rheumatologic clinical signs
15758253|NCT04791137|Behavioral|Imagery cognitive bias modification|The imagery cognitive bias modification intervention is derived from that developed via experimental psychopathology research (e.g. Holmes et al., 2009) and adapted for clinical applications in the context of depression (e.g. Blackwell & Holmes, 2010; Blackwell et al., 2015). The intervention is a series of training sessions in which participants listen to training scenarios consisting of descriptions of everyday situations, structured so that they start ambiguously but always end positively. Participants are instructed to imagine themselves in the situations described as the scenarios unfold. It is hypothesised that via repeatedly practising imagining positive resolutions for ambiguous situations in the training sessions, a bias is trained to automatically imagine positive resolutions for ambiguous situations encountered in daily life.
15758254|NCT04791124|Other|Electroencephalography|"EEG evaluation Composed by three consecutive tests
~Resting state EEG, with either eyes open or closed
~Auditory steady-state response (ASSR)
~Auditory evoked potential"
15758255|NCT04791111|Other|Questionnaire|validated questionnaire to assess side effects secondary to antimuscarinics treatment in neurogenic bladder
15758256|NCT04791098|Other|Specific infectious diseases consultation|"Specific infectious diseases consultation at Clermont Ferrand Hospital with a specialist doctor :
~Update vaccinations
~Advice to travelers
~Diagnostic and treatment of latent tuberculosis infection"
15758257|NCT04791072|Other|Exercise|Breathing exercise training Use of incentive spirometry Aerobic exercise training Strengthening exercises
15758258|NCT04791059|Drug|S-ketamine|S-ketamine 50 mg is included in the mixture for patient-controlled analgesia.
15758259|NCT04791059|Drug|Dexmedetomidine|Dexmedetomidine 200 microgram is included in the mixture for patient-controlled analgesia.
15758260|NCT04791059|Drug|Sufentanil|Sufentanil 4 microgram/kg (maximum 250 microgram) is included in the mixture for patient-controlled analgesia.
15758261|NCT04791046|Drug|antihypertensive therapy|Personalized evidence-based antihypertensive therapy in patients with comorbidities
15758262|NCT04791033|Procedure|Hysterectomy|Elective procedure with hysterectomy due to benign gynecological condition
15758263|NCT04791020|Drug|Lidocain topical + paracervical blockade|5mL of lidocaine gel applied topically to cervix previous to clamping and paracervical blockade
15758264|NCT04791020|Drug|Lidocaine topical|5mL of lidocaine gel applied topically to cervix previous to clamping, No paracervical blockade will be applied.
15758265|NCT04791007|Drug|OB-002|vaginal or rectal administration
15758266|NCT04791007|Drug|Placebo|vaginal or rectal administration
15758267|NCT04790981|Other|motor imaginary training|Each child shown a video of 5 minutes of illustrating normal movements while the child resting in semi-reclined sitting in quiet room in front the screen. Children then asked to close their eyes and imagine practicing the task like the illustrative video. Repetition of the exercises depend on the children ranging from 5 to 10 repetitions per exercise.
15758268|NCT04790981|Other|physical thertapy training|The Control group received the selected physical therapy program for one hour, three times weekly for three successive months including facilitation of balance and protective reactions from standing position, standing on one leg, weight shifting from standing, squat to standing, strengthening exercises for trunk muscles and for upper and lower extremities musculatures, gait training activities for correction of gait pattern including.
15758269|NCT04790968|Diagnostic Test|PSMA-PET|Prostate specific membrane antigen positron emission tomography
15758270|NCT04790968|Diagnostic Test|PSMA-PET/MRI|Prostate specific membrane antigen positron emission tomography combined with magnetic resonance imaging
15758271|NCT04790968|Diagnostic Test|PSMA-PET/CT|Prostate specific membrane antigen positron emission tomography combined with computed tomography imaging
15758272|NCT04790942|Drug|berberine hydrochloride|the berberine hydrochloride group (BBR) take berberine hydrochloride tablets (0.4g, 3 times/day, 3 months)
15758273|NCT04790942|Behavioral|lifestyle intervention group|The lifestyle intervention group (CON) mainly includes reducing sodium intake, healthy diet guidance, increasing exercise, quitting smoking and restricting alcohol consumption
15758274|NCT04790929|Device|Muse|Interaxon markets a head-worn EEG biofeedback device ('Muse') to encourage and aid effective meditation and sleep. This device has been previously shown to improve workplace wellness, fatigue and quality of life, and performance on the Stroop Task. It has also been shown to improve physiological markers associated with improved relaxation. Muse has been shown to have an EEG signal comparable to a clinical grade EEG.
15758275|NCT04790929|Behavioral|Meditation Coaching|Participants will be asked to use the Muse Meditation system for a minimum of 5 minutes a day (in one or multiple sessions), a minimum of 5 days a week, for 6 weeks and will be coached in how to do so. Coaches will be versed in Mindfulness and how to use Muse. Coaching will take place virtually using Interaxon's Zoom account.
15758276|NCT04790916|Drug|RO7049665|RO7049665, subcutaneous injection, Q2W.
15758277|NCT04790916|Other|Placebo|RO7049665-matching placebo, subcutaneous injection, Q2W.
15758278|NCT04790903|Drug|Venetoclax|Participants will self-administer Venetoclax, as described in the Arm Descriptions.
15758279|NCT04790903|Drug|Polatuzumab Vedotin|Participants will receive Polatuzumab Vedotin at a dose of 1.8 mg/kg by intravenous (IV) infusion on Day 1 of Cycles 1-6.
15758280|NCT04790903|Drug|Rituximab|Participants will receive Rituximab at a dose of 375 mg/m^2 by IV infusion on Day 1 of Cycles 1-6.
15758281|NCT04790903|Drug|Cyclophosphamide|Participants will receive Cyclophosphamide at a dose of 750 mg/m^2 by IV infusion on Day 1 of Cycles 1-6.
15758282|NCT04790903|Drug|Doxorubicin|Participants will receive Doxorubicin at a dose of 50 mg/m^2 by IV infusion on Day 1 of Cycles 1-6.
15758433|NCT04789785|Diagnostic Test|ultrasound|observation with usg
15758287|NCT04790864|Behavioral|Online large-group one-session treatment with post-treatment exercise targeting expectancy violation|The treatment is aimed at reducing public speaking anxiety by using cognitive and behavioral techniques. Following a psychoeducation phase, different speaking tasks are conducted to expose the individuals to their feared situation on the one hand and to address common cognitive processes characterizing public speaking anxiety, e.g. self-focused attention, on the other hand. The exercises will be conducted in smaller groups. After treatment, participants receive a worksheet with questions aimed at enhancing the processing of what was learned during treatment in terms of expectancy violation. For example, they are asked if what they were most worried about occured and what actually happened compared to what they predicted to happen. This should highlight the discrepancy between anticipated and actual outcomes. The intervention is conducted in an online group format via videoconference with a duration of approximately 5 hours.
15758288|NCT04790864|Behavioral|Online large-group one-session treatment with post-treatment control exercise|The treatment is aimed at reducing public speaking anxiety by using cognitive and behavioral techniques. Following a psychoeducation phase, different speaking tasks are conducted to expose the individuals to their feared situation on the one hand and to address common cognitive processes characterizing public speaking anxiety, e.g. self-focused attention, on the other hand. The exercises will be conducted in smaller groups. After treatment, participants receive a worksheet that addresses basic contentual information concerning the treatment without a specific attempt to highlight the discrepancy between anticipated and actual outcomes. For example, participants will be asked how they would explain public speaking anxiety and exposure therapy to a friend and what advantages they see in conducting treatments like this in groups. The intervention is conducted in an online group format via videoconference with a duration of approximately 5 hours.
15758292|NCT04790838|Drug|Test|2 inhalations of Test and Reference product in each study period
15758293|NCT04790838|Drug|Reference|2 inhalations of Test and Reference product in each study period
15758294|NCT04790825|Procedure|Full mouth scaling and root planing (FMSRP)|Subgingival instrumentation with ultrasonic devices and curettes of all periodontal pockets completed within 48 hours
15758295|NCT04790812|Drug|Celecoxib|Single, preemptive oral dose 200mg of celecoxib. A cyclooxygenase-2 (COX-2) selective inhibitor for pain management. A COX-2 selective nonsteroidal anti-inflammatory drug (NSAID).
15758296|NCT04790812|Drug|Acetaminophen|Single, preemptive oral dose 1000mg of acetaminophen. An over-the-counter medication for pain management.
15758297|NCT04790812|Drug|Placebo|A capsule with no active ingredients designed to mimic the appearance of the acetaminophen capsule to ensure blinding of patients and care providers.
15758298|NCT04790799|Other|Treatment at the skin department at Gentofte Hospital|Treatment in a hospital setting at Gentofte Hospital skin department
15758299|NCT04790786|Biological|Lilly Bamlanivimab|Administration of Lilly Bamlanivimab to COVID positive patients
15758300|NCT04790786|Biological|Regeneron Casirivimab + Imdevimab|Administration of Regeneron Casirivimab + Imdevimab to COVID positive patients
15758301|NCT04790786|Biological|Lilly Bamlanivimab + Etesevimab|Administration of Lilly Bamlanivimab + Etesevimab to COVID positive patients
15758302|NCT04790786|Biological|Sotrovimab|Administration of Sotrovimab to COVID positive patients
15758303|NCT04790773|Other|Amazon Alexa based voice recording patient education|Amazon Alexa based voice recording of medication education material
15758304|NCT04790760|Dietary Supplement|Supplement Consumption|Participants will consume one 500 mg cinnamon capsule and one 300 mg aloe vera capsule twice per day for weeks 3-6.
15758305|NCT04790760|Device|Continuous Glucose Monitors|Participants will wear a CGM on the back of their left and right arm for weeks 1-6.
15758306|NCT04790747|Drug|CAR-T cells|Each subject receives sequential radiotherapy and CAR-T cells by intravenous infusion
15758307|NCT04790734|Drug|Remimazolam Besylate|To achieve light/moderate sedation.
15758308|NCT04790734|Drug|Propofol|To achieve light/moderate sedation.
15758309|NCT04790734|Drug|Remifentanil|remifentanil
15758310|NCT04790708|Radiation|Lutetium-177 (177Lu)-DOTATOC|5 cycles of 3,7 e 5,55 gigabequerel (GBq) of 177Lu-DOTATOC every 8-10 weeks. Cumulative activity: 18,5 e 27,75 GBq
15758311|NCT04790708|Radiation|Yttrium-90 (90Y)-DOTATOC|5 cycles of 1,85 e 2,775 GBq of 90Y-DOTATOC every 8-10 weeks. Cumulative activity: 9,25 e 13,875 GBq
15758312|NCT04790708|Radiation|177Lu-DOTATOC + 90Y-DOTATOC|"3 cycles of 3,7 e 5,55 GBq of 177Lu-DOTATOC alternated with 2 cycles of 1,85 e 2,775 GBq of 90Y-DOTATOC every 8-10 weeks.
~Cumulative activity: 18,5 e 27,75 GBq of 177Lu-DOTATOC and 9,25 e 13,875 GBq of 90Y-DOTATOC"
15758313|NCT04790708|Radiation|Re-treatment 177Lu-DOTATOC|3 cycles of 3,7 e 5,55 GBq of 177Lu-DOTATOC every 8-10weeks. Cumulative activity: 11,1 e 16,65 GBq of 177Lu-DOTATOC
15758314|NCT04790708|Radiation|Re-treatment 90Y-DOTATOC|3 cycles of 1,85 e 2,775 GBq of 90Y-DOTATOC every 8-10 weeks Cumulative activity: 5,55 e 8,325 GBq of 90Y-DOTATOC
15758315|NCT04790695|Drug|Seribantumab|For the induction phase: Seribantumab 3,000 mg IV weekly for 12 weeks then Maintenance Phase: Seribantumab 3,000 mg IV infusion once every 2 weeks, initiating approximately 14 days after completion of induction phase. Dose or schedule may be adjusted at the discretion of the treating physician.
15758316|NCT04790682|Biological|assessment of the predictive value of ctDNA level of the prominent mutant allele variation between baseline and week 6, on response to treatment according to RECIST 1.1 criteria.|"At pre-screening NGS analysis on tumor tissue (slides). Only patients with at least 1 mutation at NGS on the tumor tissue will ultimately be enrolled in the main study, to have the possibility to follow the mutation using ctDNA.
~Main study will be initiated after results of the NGS and before initiation of pembrolizumab. Blood specimens will be taken with EDTA tubes or streck tubes at the time of puncture for pembrolizumab infusion at baseline before starting treatment, at 3 weeks, 6 weeks and then every 6 weeks (30 ml at Baseline then 20 ml of blood). Blood immunomonitoring will be done before starting the treatment, at 6 weeks and at 18 Week. An additional measurement will be performed if treatment is stopped before the end of the study (18 ml of blood).
~Optional blood samples will be realized to analyse the degree of activity of the plasmatic lymphocytes before starting the treatment and at 6 weeks and (18 ml of blood)."
15758317|NCT04790669|Procedure|Daily adjustable progressive resistance exercises (DAPRE)|Daily adjustable progressive resistance exercises (DAPRE) In Group A, 11 participants were received Conventional physiotherapy treatment in addition to DAPRE technique by leg extension machine. In DAPRE technique, four sets of exercises were performed. The first two sets of exercise consisted of ten and then six repetitions, per- formed against one-half and three-fourths of the previously established working weight. Working weight is the amount of weight a patient uses during an individual session. The full working weight was used on the third set, and the patient performed as many repetitions as possible. After performing each of the third and fourth sets, patients rested for 1 min.6 weeks (3 sessions per week)• Hot pack: 10 min• Stretching of calf and hamstring muscle: 10 min. Assessment was done via WOMAC index, universal goniometer, numeric pain rating scale & sphygmomanometer.
15758318|NCT04790669|Procedure|Close kinetic chain exercises (CKC).|Close kinetic chain exercises (CKC). In Group B, 11 participants was received Conventional physiotherapy treatment in addition to close kinetic chain exercises. Close kinetic chain exercises for extensor lag was seated leg press, double or single one third knee bend, step up and down exercise, wall slide with weight. Treatment time was 30 minutes and three session per week was applied on alternate day for up to 6 weeks. Pre interventional readings will be taken at baseline & post interventional readings at 6th week. 6 weeks (3 sessions per week) • Hot pack: 10 min • Stretching of calf and hamstring muscle: 10 min. Assessment was done via WOMAC index, universal goniometer, numeric pain rating scale & sphygmomanometer.
15758319|NCT04790656|Other|Conventional Therapy|Subjects will randomly placed into intervention group and control group . In addition to the physiotherapeutic program standardized by the hospital's team of physical therapists, the intervention group will perform physical exercise on a cycle ergometer with CPAP.
15758320|NCT04790656|Other|Cycle ergometer combine with CPAP|Physical exercise on a cycle ergometer combine with CPAP will be performed in a single daily session from the second to the fourth postoperative days . The maximum exercise time for postoperative day 2 will be 20 min, and 30 min for the third and fourth postoperative days.
15758321|NCT04790643|Other|Exercise-based cardiac rehabilitation program (Stage 1)|In Stage 1 the volunteers will perform 24 sessions of exercise-based cardiac rehabilitation. The rehabilitation session is composed of the following activities: I. Initial rest (where the vital signs are evaluated); II. Warming-up (composed of 15 minutes of stretching and global exercises); III. Aerobic exercise (composed of 30 minutes of treadmill or cycle ergometer exercise, the intensity established varies from 40 to 70% of the heart rate reserve for those diagnosed with cardiovascular diseases and from 60 to 80% of the heart rate reserve for those with only cardiac risk factors); IV. Cooldown (composed of 5 minutes of slow walking).
15758322|NCT04790643|Other|Exercise-based cardiac rehabilitation program (Stage 2)|In Stage 2, the volunteers will perform 24 sessions of exercise-based cardiac rehabilitation. The rehabilitation session is composed of the following activities: I. Initial rest; II. Warming-up; III. Aerobic exercise (these three activities are the same as stage 1); IV. Resistance training (composed of 15 minutes of individualized resistance exercises); V. Cooldown.
15758323|NCT04790630|Other|Computerized Cognitive Remediation of Executive Functioning (CCR-EF)|computerized experimental brain-training treatment
15758324|NCT04790630|Other|Active Control|computerized intervention that follows recommendations for cognitive fitness
15758325|NCT04790617|Behavioral|Community Health Navigator Program|Patients will be matched to a community health navigator (CHN) who will conduct a needs assessment to determine the frequency of meetings. A CHN may perform any of the following: providing information to a patient's health care provider, translation, advocating for the patient, connecting the patient with resources (e.g., social, financial, insurance), helping patients set health-related goals, facilitating health care referrals and appointments, and monitoring appointments. These activities may require the CHN to be physically present at appointments or have direct contact with the patient's health care provider. Goal setting and support will be provided in-person or over the telephone using motivational interviewing principles.
15758326|NCT04790604|Behavioral|Community Health Navigator Program|Patients will be matched to a community health navigator (CHN) who will conduct a needs assessment to determine the frequency of meetings. A CHN may perform any of the following: providing information to a patient's health care provider, translation, advocating for the patient, connecting the patient with resources (e.g., social, financial, insurance), helping patients set health-related goals, facilitating health care referrals and appointments, and monitoring appointments. These activities may require the CHN to be physically present at appointments or have direct contact with the patient's health care provider. Goal setting and support will be provided in-person or over the telephone using motivational interviewing principles.
15758327|NCT04790591|Procedure|Same-day surgery|To be allowed same-day discharge certain postoperative criteria have to be met. These are categorized into four dimensions - vital parameters, urinary function, bleeding, and mobilization.
15758328|NCT04790578|Device|ZoeInsights Application|ZI is designed to promote PA behavior change and maintenance via self-monitoring of PA, symptoms, and other health data. Additional information for using ZI will be provided via a PDF-based user guide on installing and using the application, a live instructional webinar hosted by ZI developer Hanalytics Solutions, and access to continued support via email/telephone communication with study staff as well as Hanalytics Solutions. Reminders to complete self-monitoring tasks will be provided using daily push notifications scheduled according to participant preferences. Automatic graphs will be generated and displayed within the app to allow participants to visualize trends in physical activity, symptoms, and other health data. ZI can be accessed via a web browser on any device that is connected to the internet (e.g. computer, laptop, tablet, smartphone), or via a native android or iOS mobile application on a smartphone or tablet.
15758329|NCT04790578|Behavioral|EXCEL Exercise Class|The group based remote exercise program is delivered twice a week over the Zoom application. Classes are one hour long with a ten minute warm up, 40 minute strength and conditioning focused exercise circuits, and a ten minute stretching. Each class is followed by additional time to provide participants with an opportunity to interact with each other, fostering social support.
15758330|NCT04790565|Biological|FMT|Fecal microbiota in frozen capsules
15758331|NCT04790552|Other|Dinner|Study subjects will consume a standardized ready-to-eat meal as dinner.
15758332|NCT04790552|Other|Fasting|Subjects will be asked to fast overnight for approximately 15 hours.
15758333|NCT04790552|Other|Fast Bar|Subjects will be asked to consume a Fast Bar.
15758334|NCT04790552|Other|Bar with Coffee|Subjects will be asked to consume a Fast Bar with coffee.
15758337|NCT04790526|Other|Eccentric Exercises Dose|Eccentric exercise will be done treadmill in control environment. The treadmill will be declined to 16 degree and 3 sessions of 10 minutes duration will be given wit 1 minute of rest in each session. 10 minutes of warm up and cool down session will be given that includes stretching and stationary bicycle with out any resistance
15758338|NCT04790513|Biological|lerodalcibep|anti-PCSK9 small binding protein
15758339|NCT04790513|Biological|evolocumab|monoclonal antibody to PCSK9
15758340|NCT04790513|Biological|alirocumab|monoclonal antibody to PCSK9
15758341|NCT04790500|Other|mobilization technique|Mobilization of sacroiliac joint which will increase the range of motion and reduction in pain and improvement in functional limitation.
15758342|NCT04790500|Other|muscle energy technique|Muscle energy technique it is known as active muscular relaxation technique. It helps in lengthening the shorten muscle and increasing range of restricted muscles
15758343|NCT04790487|Drug|CPM|one spray dose (~100 µL of the solution containing 1.25 mg CPM) per nostril twice a day
15758344|NCT04790487|Drug|Placebo|Saline
15758345|NCT04790474|Drug|ixazomib-pomalidomide-dexamethasone|"Cycles 1-3: during each 21-day cycle:
~ixazomib 3 mg on Days 1, 4, 8 and 11
~pomalidomide 4 mg on Days 1 through 14
~dexamethasone 20 mg on Days 1, 2, 8, 9, 15, 16
~Cycle 4 and consequently: during each 28-day cycle:
~ixazomib 4 mg on Days 1, 8 and 15
~pomalidomide 4 mg on Days 1 through 21
~dexamethasone 20 mg on Days 1, 2, 8, 9, 15, 16, 22 and 23"
15758346|NCT04790461|Other|Pre-post test|Adult Caregiver Quality of Life Questionnaire (AC-QoL) Perceived Stress Scale (PSS) The Stress Coping Styles Questionnaire (SCSQ)
15758347|NCT04790461|Behavioral|face-to-face training + PMR exercise|4 weeks Roy adaptation-based face-to-face training + PMR exercises to be taught, 4 weeks exercise counseling
15758348|NCT04790461|Behavioral|mobile health education + PMR exercise|To provide awareness and exercise with 8 weeks Roy adaptation model-based training and mobile application access with PMR exercise content
15758349|NCT04790461|Behavioral|face-to-face and mobile health education + PMR exercise|4 weeks face-to-face training based on Roy adaptation model + teaching PMR exercises and 4 weeks based training on Roy adaptation model and mobile application access with PMR exercise content
15758350|NCT04790448|Drug|Cetuximab|Route of administration: Intravenous
15758351|NCT04790448|Drug|Irinotecan|Route of administration: Intravenous
15758352|NCT04790448|Drug|Vemurafenib|Route of administration: Oral
15758353|NCT04790422|Dietary Supplement|Dietary fiber supplement|Dietary fiber
15758354|NCT04790422|Dietary Supplement|Caseine protein hydrolisate|Dietary supplement
15758355|NCT04790422|Dietary Supplement|Maltrodextrine|Placebo comparator
15758356|NCT04790409|Drug|PD-1 inhibitor and anlotinib|This study was a one-arm, open-label, phase II study of PD-1 monoclonal antibody combined with ilotinib in the treatment of advanced EGFR rare-mutant non-small cell lung cancer (NSCLC). Thirty patients enrolled in the study who underwent platinum-containing systemic chemotherapy and EGFR-TKI failure were enrolled in the study.
15758357|NCT04790396|Device|Carotid ultrasound under pulsed-wave doppler mode|Carotid ultrasound under pulsed-wave doppler mode to check whether carotid pulse is present
15758358|NCT04790383|Other|Advanced Self-Adhesive resin composite hybrid restorations (Surefil one (Dentsply Sirona)).|Hybrid resin composite that doesn't need bonding system and releases calcium and flouride.
15758359|NCT04790383|Other|Conventional resin composite restoration. (Sphere Tec, (Dentsply Sirona|Conventional Nanohybrid resin composite
15758360|NCT04790370|Drug|Anticoagulation with heparin|Low-molecular weight heparin (LMWH) or unfractionated heparin (UFH)
15758361|NCT04790370|Device|EkoSonicTM Endovascular System|EkoSonicTM Endovascular System [ultrasound-facilitated catheter-directed delivery of thrombolytic: 2 mg bolus/catheter + 1 mg/hour/catheter for 7 hours (total of 9 or 18 mg]
15758362|NCT04790357|Other|Current guidelines|doppler ultrasound and/or angio CT-scan of the cervical arteries, angio CT-scan of the intracranial arteries, TTE wich can be supplemented by a TEE at the discretion of the investigator. The TEE is not mandatory
15758363|NCT04790357|Other|cc-MRI|of one-shot cardiac-cervical-intracranial MRI: cardiac MRI with late-enhancement, angio-MRI of the cervical and intracranial arteries
15758364|NCT04790344|Device|Investigational LUX-Dx ICM Implant|All subject will receive an investigational version of the LUX-Dx ICM device.
15758365|NCT04790331|Drug|Verapamil|Verapamil is a phenylalkylamine calcium channel blocker used in the treatment of high blood pressure, heart arrhythmias, and angina
15758366|NCT04790331|Drug|Diltiazem|"Diltiazem is a calcium channel blocker. It works by relaxing the muscles of your heart and blood vessels.
~Diltiazem is used to treat hypertension and angina."
15758367|NCT04790331|Drug|Placebo|Placebo oral tablet
15758368|NCT04790318|Procedure|Trans-incisional Quadratus lumborum block|patients will receive combined general anesthesia and quadratus lumborum block (trans-incisional) with 0.5 mL/kg of bupivacaine 0.2 %. with maximum volume was limited to 20 ml
15758369|NCT04790318|Procedure|Caudal block|patients will receive combined general anesthesia and caudal analgesia (just after wound closure) with 1.25 mL/kg of bupivacaine 0.2 % (three parts 0.25 % bupivacaine to one part saline.
15758370|NCT04790305|Drug|Huaier Granule|The subjects in the experimental group will be treated with Huaier Granule continuously for 2 years or until the disease progressed, intolerable toxicity, withdrawal of informed consent form or died for any reason.
15758371|NCT04790292|Drug|group M|10mg morphine in 5ml normal saline + 10ml of 0.25% bupivacaine ( total volume 15 ml) were injected intra-articularly
15758372|NCT04790292|Drug|group MD|10mg morphine + 8mg dexamethasone completed to 5 ml with normal saline + 10 ml of 0.25% bupivacaine (total volume of 15ml) were injected intra-articularly
15758373|NCT04790279|Drug|Amlodipine|Initiation of amlodipine 2.5 mg
15758374|NCT04790279|Drug|NIFEdipine ER|Initiation of nifedipine ER 30 mg
15758375|NCT04790266|Diagnostic Test|Cardiac MRI|cCardiac MRI, ecocardiography and cardiotoxicity blood tests will be repeated as previously scheduled
15758376|NCT04790253|Radiation|Prophylactic cranial irradiation|Prophylactic cranial irradiation (PCI) is a technique used to combat the occurrence of metastasis to the brain in highly aggressive cancers that commonly metastasize to brain, most notably small-cell lung cancer.
15758506|NCT04789148|Drug|Oxytocin nasal spray|4 IU intranasal oxytocin, 24 IU intranasal oxytocin or placebo
15758545|NCT04788797|Other|Placebo|Two capsules three times a day
15758377|NCT04790240|Dietary Supplement|Inflammation (I)|"upper respiratory inflammation (PurInf (I)): Lonicerae Flos 2.4g, Forsythiae Fructus 2.4g, Schizonepetae Herba 2g, Saposhnikoviae Radix 2g, Cicadae Periostracum 1g, Sophorae flavescentis Radix 2.4g, Atractylodis Rhizoma 2g, Angelicae dahuricae Radix 2g, Menthae haplocalycis Herba 2g, Arctii Fructus 2g, Glycyrrhizae Radix 1g
~high fever (PurInf (II)): Bupleuri Radix 3g, Scutellariae Radix 2.4g, Gypsum fibrosum 4g, Anemarrhenae Rhizoma 3g
~lower Respiratory system inflammation (PurInf (III)): Scutellariae Radix 2.4g, Coptidis Rhizoma 1g, Phellodendri Cortex 2.4g, Gardeniae Fructus 2.4g, Houttuyniae Herba 4g, Golden Buckwheat 3g"
15758378|NCT04790240|Dietary Supplement|Inflammation (II)|Platycodi Radix 2.4g, Peucedani Radix 2.4g, Cynanchi stauntonii Rhizoma 2.4g, Asteris Radix 2.4g, Stemonae Radix 2.4g, Lepidii Descurainiae Semen 2.4g, Plantaginis Semen 2.4g
15758379|NCT04790240|Dietary Supplement|Inflammation (III)|"Metabolites, abnormal fluids (PurPhl):
~Citri reticulatae Pericarpium 1.2g, Citri grandis Exocartium rubrum 2g, Aurantii Fructus immaturu 2g, Pinelliae Rhizoma preparatum 2.4g, Arisaematis Rhizoma preparatum 2.4g, Amoni Fructus 1g, Trichosanthis Fructus 2.4g, Fritillatiae cirrhosae Bulbu 2.4g, Poria 2.4g, Rhei Radix et Rhizoma 1g
~Capillaries circulation disorder (PurClo):
~Salviae miltiorrhizae Radix 2.4g, Curcumae Radix 2.4g, Paeoniae Radix rubra 2.4g, Persicae Semen 2.4g, Carthami Flos 2.4g"
15758380|NCT04790240|Drug|Standard of care|remdesivir (Veklury), Colchicine, anti-SARS-CoV-2 monoclonal antibodies, bamlanivimab, Casirivimab & Imdevimab.
15758381|NCT04790227|Device|MRI|MRI
15758382|NCT04790214|Other|CHF Patients|Cardiac rehabilitation program on CHF patients on 06-08 weeks. Program will include: physical aerobic re-training, therapeutic education on CHF, psychological follow-up, nutritional education
15758383|NCT04790201|Behavioral|Friendship Bench Delivered by Professional Counselor|Participants randomized to this arm will receive the Friendship Bench protocol delivered by a professional counselor.
15758384|NCT04790201|Behavioral|Friendship Bench Delivered by Lay Counselor|Participants randomized to this arm will receive the Friendship Bench protocol delivered by a trained lay counselor.
15758385|NCT04790201|Behavioral|Enhanced Usual Care|Enhanced usual care (EUC) will include general training of the HIV providers and clinics about CMD identification and management, and feedback to the HIV provider of the status of their enrolled patient to allow follow-up per the clinic's standard care. Information will be collected in follow-up interviews to characterize the care that patients receive. These activities will occur in all three arms, but they are the only activities in the EUC arm.
15758386|NCT04790188|Dietary Supplement|Nootropic|10g of Evo-Gamers® lemon flavor (HSN®). The nutritional composition per service is: L-Tyrosine (1000mg), Acetyl L-Carnitine HCL (500mg), Citicoline sodium (200mg), L-alpha-Glycerylphosphorylcholine (Alpha-GPC; 100mg), Vitamin C (150mg), Vitamin E (12.1mg), Vitamin B6 (3mg), Vitamin B2 (3mg), Vitamin A (810μg), Vitamin D (10μg), Vitamin B12 (5μg), Taurine (500mg), Caffeine (300mg), L-Theanine (150mg), Mango Leaves (2000mg), Huperzia Leaves (200mg). The dose to be administered is that recommended on the labeling and nutritional information of the nootropic which has been produced under GMP procedures and approved by the EFSA.
15758387|NCT04790188|Dietary Supplement|Placebo|10g of maltodextrin lemon flavor (HSN®).
15758388|NCT04790175|Drug|Tolvaptan (SAMSCA)|The usual adult dose of SAMSCA is 7.5 mg of tolvaptan once daily administered orally, increased stepwise to 60 mg daily until a desirable level of serum sodium concentration is achieved.
15758389|NCT04790162|Behavioral|Heartfulness Meditation|Heartfulness meditation with a trainer provided virtually
15758390|NCT04790149|Other|Conventional Rehabilitation|Motor Imagery Training combined with Active functional exercises
15758391|NCT04790149|Other|NEUROM + tDCS|NEUROM combined to tDCS
15758392|NCT04790149|Other|NEUROM|protocol to induce motor recovery
15758393|NCT04790136|Drug|GLA-015|administration followed by PK blood sampling
15758394|NCT04790136|Drug|"DAC C-052 Cannabidiol / NRF 22.10 Oily cannabidiol solution 100 mg/ml"|administration followed by PK blood sampling
15758395|NCT04790123|Procedure|Injection of autologous freshly collected adipose tissue|injection of fresh autologous fat, previously lipoaspirates from the patient's abdomen and centrifugated, into the fistulous tract, after curettage and closure of the internal opening.
15758396|NCT04790123|Procedure|sham|curettage and closure of the internal orifice of the anal fistula and simulated intervention in the abdomen.
15758397|NCT04790097|Radiation|Moderately Hypofractionated Radiotherapy using Simultaneous In-Field Boost|"78Gy in 30 fractions on FET-PET based target volumes;
~60Gy in 30 fractions on 2cm margin from MRI based target volumes;
~all patients will be treated with concomitant and adjuvant temozolomide"
15758398|NCT04790084|Other|no intervention|no intervention
15758399|NCT04790071|Other|Conventional physical therapy|Conventional physical therapy: The patients received physical therapy to the shoulder, transcutaneous electrical nerve stimulation, and stretching and strengthening exercises (5 days per week for three weeks in a total of 15 sessions).
15758400|NCT04790071|Other|Conventional physical therapy plus dry needling|Conventional physical therapy plus dry needling: The patients received physical therapy to the shoulder, including transcutaneous electrical nerve stimulation, stretching, and strengthening exercise (5 days per week for three weeks in a total of 15 sessions). And also, a total of 3 dry needling sessions were applied at 7-day intervals.
15758401|NCT04790058|Other|Knowledge translation of the CSRS practice recommendations|The intervention is knowledge translation of the CSRS practice recommendations. The first month of the intervention period will be designated as a transition period during which we will undertake intense educational efforts. The practice recommendations will be available online to physicians involved in ED syncope care. The practice recommendations and the online calculator will either be integrated into the electronic medical records (EMR) platforms or a hyperlink provided to physicians at the two hospitals for easy reference and score calculation. The intervention which is the application of the practice recommendations will occur during the patient's ED visit and patients who are eligible for 15-day cardiac rhythm monitoring will have their device applied either at the time of ED discharge or the next day morning.
15758402|NCT04790045|Drug|Venetoclax|Core-needle biopsy to be performed before starting treatment in patients candidates to venetoclax-based regimens
15758403|NCT04790032|Drug|Cangrelor|All patients receiving Cangrelor during PCI will be enrolled and analyzed for platelet function tests.
15758434|NCT04789772|Device|Laser acupuncture|The interventional group receive laser acupuncture applied on acupoints of PC6 (Neiguan), HT7 (Shenmen), LI4 (Hegu), ST36 (Zusanli), SP6 (Sanyinjiao), and LR3 (Taichong).
15758404|NCT04790019|Behavioral|Low energy availability|Participants will be provided with food to eat every day and will not be permitted to consume any other calorie containing foods or beverages. This amount of energy contained within the food provided will be one third of that contained in the food provided in the control condition (45 kilo-calories per kilogram of fat-free mass per day) and will be standardized between and within participants for carbohydrate, protein and fat composition.
15758405|NCT04790019|Behavioral|High impact jumping|Participants will perform a brief session of high impact jumping every morning (10 maximum effort vertical counter-movement jumps, and 5 maximum effort lateral drop jumps in each direction) and a similar session of high impact jumping every evening (20 maximum effort vertical counter-movement jumps).
15758406|NCT04790006|Drug|TG103|Administered SC
15758407|NCT04790006|Drug|Placebo|Administered SC
15758408|NCT04789993|Other|No intervention.|There is no intervention needed. It is a retrospective cohort. The usual follow-up of type 1 diabetes is studied from its beginning to the last news of the patient.
15758409|NCT04789967|Behavioral|Guided Imagery|Individualized Guided Imagery (GI) technique, an alternative type of relaxation therapy. The content of GI usually includes scenery, places or any image projected to the mind. By using information generated, participants are guided to create a place in their mind using their senses of touch, sound, smell, sight and taste.
15758410|NCT04789967|Behavioral|Progressive Muscle Relaxation|Progressive muscle relaxation (PMR) therapy works by progressively relaxing and tensing the muscle groups throughout the entire body. Each muscle group will be tensed for about 5 seconds. If there's any pain or discomfort at any of the targeted areas, participants were told to omit that particular step. Constant purposeful deep breathing was instructed throughout the session especially in between changes of muscle.
15758411|NCT04789967|Other|Educational Audiobook|Participants in the control group will receive an audiobook that targets to educate patients regarding gut-brain disorders, functional gastrointestinal disorders, causes of functional abdominal bloating, and treatment modalities available. Relaxing musical background will be added to facilitate the delivery.
15758412|NCT04789954|Biological|Eptacog alfa, activated|A dose sequence for each injection will be randomly selected from the following doses: 10 μg/kg, 30 μg/kg, 90 μg/kg, or 270 μg/kg, separated by a wash-out period of 3 days.
15758413|NCT04789941|Drug|Cis Platinum + Irinotecan|Studying the efficacy and safety of neoadjuvant cisplatin and irinotecan use in treatment of locally advanced cancer cervix.
15758414|NCT04789928|Drug|Gentamicins-EDTA|Patients included in this study will receive daily injection (up to 10 days) of genta-EDTA-Na2 lock associated with systemic antibiotics.
15758415|NCT04789915|Drug|Memantine|Add on treatment with memantine to amisulpride.
15758416|NCT04789915|Drug|Placebo|Placebo add on to amisulpride
15758417|NCT04789902|Other|SurgeCon|The SurgeCon intervention is a pragmatic ED management platform that includes three distinct intervention components which include 1) Restructuring ED Organization & Workflow, 2) Establishing a Patient-Centric ED Environment, and 3) E-Health Action-Based ED Management that together act to improve ED efficiency and patient satisfaction and value of care.
15758418|NCT04789889|Radiation|intraoperative radiotherapy|intraoperative radiotherapy
15758419|NCT04789889|Radiation|postoperative radiotherapy|postoperative radiotherapy
15758420|NCT04789876|Other|Phosphate mobile app|The phosphate mobile app has the features of i) matching phosphate binder with dietary phosphate intake, ii) educational videos of phosphate management, iii) food database with local food items, iv) record-keeping and goal setting.
15758421|NCT04789876|Behavioral|One-off dietary counselling with a phosphate booklet|One-off 45-minute dietary counselling delivered by a dietitian at the baseline of the study. Patients received a complimentary phosphate booklet after the counselling session. The phosphate booklet contains similar educational information as per the phosphate mobile app excluding the matching of phosphate binder with dietary phosphate information.
15758422|NCT04789863|Device|SMILe-Integrated Care Model|"Four self-management intervention modules will be delivered by human and technology: 1) monitoring & follow-up; 2) infection prevention; 3) medication adherence; 4) physical activity.
~Human. A CC will provide structured and tailored self-management and behavioural support regarding all 4 modules via 12 face-to-face meetings congruent with planned clinic follow-up visits. The CC will be connected with the patients via the SMILe technology, enabling rapid responses to early signs of health deterioration.
~Technology. The SMILe technology consists of the SMILeApp and SMILeCare. The latter is the interface of the monitoring component to connect the patient with the CC supporting fast recognition of symptoms and health deterioration. The SMILeApp enables to daily record a set of medical, behavioural and symptom-related data. A lexicon provides self-management and behavioural information. All data will be transferred to the clinic to be monitored, with the patient's consent, via SMILeCare."
15758423|NCT04789863|Other|Usual Care|The control group (CG) participants will receive usual care, which includes no specific counselling. USB outpatient appointment frequency follows a standard schedule: during the first 3 months post-alloSCT, depending on their health status, most patients (73%) return 1 to 3 times per week for follow-up at the USB outpatient clinic, where they are mainly seen by a junior or senior physician. Depending on health status and recovery, follow-up intervals extend to weekly or monthly within 1 year post-alloSCT. A research assistant (RA) will just contact CG participants for data collection. If participants raise concerns about any symptoms, the RA will encourage them to contact their physicians.
15758424|NCT04789850|Drug|Itacitinib|200 mg oral for 360 days
15758425|NCT04789850|Drug|Placebo|200 mg oral for 360 days
15758426|NCT04789837|Drug|Cilostazol 50 MG|Cilostazol 50 mg twice daily plus Celecoxib 200mg capsule
15758427|NCT04789837|Drug|Placebo|Placebo tablet twice daily plus Celecoxib 200mg capsule
15758428|NCT04789824|Behavioral|eyelid hygiene|EH
15758429|NCT04789811|Other|Stretching exercise|Stretching exercise: Stretching exercises were planned for 30 seconds, ten repetitions for each stretching, 10 minutes in total, four days a week, for two weeks.
15758430|NCT04789811|Other|Dry needling|Dry needling: A total of 3 sessions of dry needling, once a week, were applied to the gastrocnemius muscle.
15758431|NCT04789798|Device|TeleDiab (Telemedicine)|"TeleDiab program components consist of:
~Electronic transmission of capillary blood glucose measurement results
~Electronic transmission of blood pressure measurements
~Synchronized video-conferencing, secure messaging
~Access to clinical data from patient files when necessary
~Reminding of routine follow-up tests and examinations
~Providing web-based educational materials to patients."
15758435|NCT04789759|Device|Socket Preservation - Bond Apatite synthetic bone substitute|"Pre-op CBCT scanner for evaluating bone conditions around hopeless tooth. If 1/3 of the buccal plate is missing, considered a class 2 alveolar socket.
~Extraction of tooth and place 2/3 biphasic calcium sulfate cement matrix's with Hydroxyapatite (HA granules) , condensed , and covered with a resorbable membrane suture to the adjacent tissue.
~At implant placement ,take bone for histological preparation and histomorphometric analysis of the healing pattern.
~At T0, T1 and T2 measure adjacent teeth periodontal status , Probing Depth , bleeding on probing.
~Volumetric measurements, will use fixed landmarks (ex. adjacent teeth) to calibrate the STL measurements. Calculate the difference between pre-extraction socket and the post treatment with the alloplastic material.
~Primary and secondary stability will be measured by ISQ units with a RFA machine, that will include the machine to measure and the magnetic tip to be screwed in the implant platform."
15758436|NCT04789759|Procedure|Socket healing - No Filler|"Pre-op CBCT scanner for evaluating bone conditions around hopeless tooth, at extraction day, no flap opening , atraumatic extraction, no biomaterial filler, At T0, T2 measure adjacent teeth periodontal status , Probing Depth , bleeding on probing.
~Volumetric measurements will include an intramural scanner from all the stages , we will use fixed landmarks (ex. adjacent teeth) to calibrate the STL measurements. Calculate the difference between pre-extraction socket and the post treatment with the alloplastic material."
15758437|NCT04789746|Behavioral|adapted Chicago Run running program|The intervention being piloted is a 6-8 week running program modified from a running curriculum designed for school-aged children. The children will use a RaceRunner device to facilitate their participation, but this device is not explicitly evaluated in this study. Depending on transportation, they may be given access to the device in their home or school between sessions after it has been fit for them. If given access, guardians will be instructed on care and usage.
15758438|NCT04789733|Other|Tight pressure management|Norepinephrine or phenylephrine infusion to maintain intraoperative MAP ≥85 mmHg, delayed resumption of chronic antihypertensive medications, and a target ward MAP ≥80 mmHg (tight pressure management)
15758439|NCT04789733|Other|Routine pressure management|Routine intraoperative blood pressure management and immediate restart of antihypertensive medications.
15758440|NCT04789720|Behavioral|Symptom Monitoring & Systematic Assessment and Reporting System in Young Survivors (SyMon-SAYS)|Participants will complete a 9-item SyMon-SAYS symptom assessment checklist every week during the intervention phase (Intervention Group: weeks 1-16; Waitlist Control: weeks 9-16) through Epic MyChart via mobile app, computer or tablet. Patients' symptom scores will be monitored and reported to their oncology care providers. When a patient symptom score trigger threshold is met, the system will generate an email alert through Epic (electronic medical record system) messaging to the provider. The provider will take appropriate actions using his/her clinical judgement, including contacting patients and families when needed. Symptom scores overtime will be available in MyChart (patient-facing component of the Epic electronic medical record system) for patients and parents to review and to discuss with the child's provider during clinical visits.
15758441|NCT04789707|Behavioral|auto-questionnaire|Patients answer the auto questionnaire in last minutes of consultation.
15758442|NCT04789694|Other|Physiological intervention|"Rehabilitation specialist consultation
~Functional capacity measuring"
15758443|NCT04789694|Behavioral|Psychological intervention|"Clinical psychologist consultation
~Anxiety and depression scoring
~Psychological support"
15758444|NCT04789694|Dietary Supplement|Nutritional intervention|"Nutritional specialist consultation
~Malnutrition scoring
~Dietary supplementation"
15758445|NCT04789681|Drug|Canakinumab|Given SC
15758446|NCT04789681|Other|Quality-of-Life Assessment|Ancillary studies
15758447|NCT04789668|Drug|Bintrafusp Alfa|Given IV
15758448|NCT04789668|Drug|Pimasertib|Given PO
15758449|NCT04789668|Other|Quality-of-Life Assessment|Ancillary studies
15758450|NCT04789655|Drug|CC-96191|CC-96191
15758451|NCT04789642|Other|blood pressure measurement whatsapp educational program|educational
15758452|NCT04789629|Device|low level laser therapy|3 session per week laser with exercises
15758453|NCT04789616|Drug|Maraviroc|Half of the participants will take maraviroc for a period of 8 weeks.
15758454|NCT04789616|Behavioral|Exercise Program|"All participants will take part in an 8-week exercise program. While in-hospital, participants will undergo standard of care rehabilitation (estimated at 45 minutes each daily for PT & OT) plus a supplementary upper extremity exercise program (Graded Repetitive Arm Supplementary Program (GRASP); estimated at 1 hour daily).
~After discharge from inpatient care, participants will complete an at-home supplementary upper and lower extremity exercise program. This program will include walking daily and daily practice using the GRASP program."
15758455|NCT04789616|Other|Placebo|Half of the participants will take a placebo for a period of 8 weeks.
15758456|NCT04789603|Other|6-min-walk surgical mask|To walk as fast as possible without running for 6 minutes with surgical mask
15758457|NCT04789603|Other|6-min-walk Fpp2|To walk as fast as possible without running for 6 minutes with Fpp2 mask
15758458|NCT04789603|Other|6-min-walk without mask|To walk as fast as possible without running for 6 minutes without mask
15758459|NCT04789577|Biological|FLU-Q-PAN H7N9 Formulation 1|Participants will receive two doses of the FLU-Q-PAN H7N9 Formulation 1 vaccine by intramuscular injection in the non-dominant arm.
15758460|NCT04789577|Biological|FLU-Q-PAN H7N9 Formulation 2|Participants will receive two doses of the FLU-Q-PAN H7N9 Formulation 2 vaccine by intramuscular injection in the non-dominant arm.
15758461|NCT04789577|Biological|FLU-Q-PAN H7N9 Formulation 3|Participants will receive two doses of the FLU-Q-PAN H7N9 Formulation 3 vaccine by intramuscular injection in the non-dominant arm.
15758462|NCT04789577|Biological|AS03B|Participants will receive two doses of the AS03B adjuvant by intramuscular injection in the non-dominant arm.
15758463|NCT04789577|Biological|AS03A|Participants will receive two doses of the AS03A adjuvant by intramuscular injection in the non-dominant arm.
15758464|NCT04789577|Drug|Placebo|Participants will receive two doses of Placebo by intramuscular injection in the non-dominant arm.
15758465|NCT04789564|Diagnostic Test|cardiovascular magnetic resonance (CMR)|Testing CMR on patients of 7 days and 6 months after myocardial infarction
15758466|NCT04789551|Other|Blood Sample|a blood sample will be collected
15758467|NCT04789538|Other|monofocal lens|not applicable as patients are already implanted with the monofocal intraocular lens
15758468|NCT04789525|Other|High-intensity aerobic training with high protein diet|High-intensity aerobic training was given with 50 to 70 % of the maximum heart rate. the intervention started with 10 mins of warm-up exercise through stretching of upper and lower limb muscles. Subsequent to stretching, the subjects were asked to do 30 mins of exercises; consisting of 20 mins on the treadmill and 10 mins of cycle ergometer at 50 to 70 % of MHR, then with 10 mins of cool down.
15758469|NCT04789512|Other|Respiratory functions|Respiratory muscle strength, pulmonary functions and body composition were evaluated in volleyball players
15758470|NCT04789499|Drug|Theophylline Powder|"Theophylline is a known phosphodiesterase inhibitor in the treatment of asthma. Evidence for post-viral olfactory dysfunction suggests sensory axonal regeneration and olfactory signaling may rely on elevated levels of secondary messengers cAMP and cGMP, a known effect of theophylline. Therefore it is hypothesized to help treat COVID-related smell dysfunction, especially if delivered intranasally.
~Twice daily nasal irrigation with 400 mg theophylline capsules and USP Grade Sodium Chloride & Sodium Bicarbonate Mixture (pH balanced, Isotonic & Preservative & Iodine Free) commercially prepared packets dissolved in 240 ml of distilled water."
15758471|NCT04789486|Drug|AGuIX|Injected gadolinium-based nanoparticles
15758472|NCT04789486|Radiation|Radiotherapy|Stereotactic magnetic resonance-guided adaptive radiation therapy
15758473|NCT04789473|Genetic|Polygenic Risk Score Generation|PRS will be calculated for gestational diabetes risk using both cohorts, participants wont have results returned to them during the study.
15758474|NCT04789434|Drug|PD-1 Inhibitor Tislelizumab maintenance therapy|PD-1 Inhibitor Tislelizumab maintenance therapy, 200mg, every 2 months, 12 times
15758475|NCT04789421|Device|Clinical, dermoscopy and Reflective confocal microscopy evaluations|Adjunctive reflective confocal microscopy to dermoscopy and clinical dermatological evaluation.
15758476|NCT04789421|Device|Clinical, dermoscopy evaluations|Dermoscopy and clinical dermatological evaluation only
15758477|NCT04789408|Drug|Cyclophosphamide|Administered intravenously
15758478|NCT04789408|Drug|Fludarabine|Administered intravenously
15758479|NCT04789408|Biological|KITE-222|A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously
15758480|NCT04789382|Device|LID018869+RepleniSH|Lehfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with OPTI-FREE® RepleniSH® multi-purpose disinfecting solution (RepleniSH)
15758481|NCT04789382|Device|LID018869+Biotrue|Lehfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with Biotrue® multi-purpose solution (Biotrue)
15758482|NCT04789382|Device|Biofinity+RepleniSH|Comfilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with OPTI-FREE® RepleniSH® multi-purpose disinfecting solution (RepleniSH)
15758483|NCT04789382|Device|PV+Biotrue|Balafilcon A silicone hydrogel spherical contact lens pre-cycled (pre-soaked prior to dispense) with Biotrue® multi-purpose solution (Biotrue)
15758484|NCT04789369|Behavioral|Questionnaires|Assessing the behavioral metrics (quality of life, functionality and fear of movement) with appropriate measurement tools
15758485|NCT04789356|Biological|Adsorbed SARS-CoV-2 (inactivated) vaccine|600 SU/dose; Two doses separated by 28 days (± 7 days). Intramuscular (deltoid) administration.
15758486|NCT04789343|Other|Root canal treatment|The patient usually takes anaesthesia before treatment and access cavity was prepared on the tooth and root canal removed and instrumented and obturated. However, in the present study, previously done root canal was retreated. Usually no anaesthesia was used because all root canals were done before. So just instrumentation and obturation was done.
15758487|NCT04789330|Drug|Norepinephrine|Norepinephrine administered during anesthesia
15758488|NCT04789330|Drug|Phenylephrine|Phenylephrine administered during anesthesia
15758492|NCT04789291|Drug|BI 1595043|BI 1595043
15758493|NCT04789278|Other|Notification|Notification of coronary calcium to the patient and their clinician
15758494|NCT04789265|Other|instrumented- assisted soft tissue mobilization (IASTM)|IASTM is a new, non-invasive, conservative therapeutic approach. Instead of the therapist's hands and fingers in treatment, these devices are used to provide contact mobilization power. AYDM intervention, such as friction, rubbing massage treatments, requires the therapist to apply a significant amount of pressure. The main purpose of IASTM is to eliminate scar tissue and to restore the normal function of the tissue following soft tissue regeneration.
15758495|NCT04789252|Biological|Bioinformatics analysis of single cell transcriptomics data|"Sample collection: Myeloid cell purification + Single cell sequencing
~Primary analysis: QC sequencing data + Reads alignment + UMI quantification
~Bioinformatics analysis: Quality Control (Number of genes, UMI content,%mitochondrial genes, % riboprotein genes,Filtering low quality cells) + Normalization and scaling (Normalization, Remove unwanted sources of variation, HVG detection) + PCA Clustering Markers (PCA and PC selection, Clustering, t-SNE, Differential expression for markers identification)
~Validation: FACS analysis + immunohistochemistry"
15758496|NCT04789239|Drug|Sodium zirconium cyclosilicate|SZC is an approved drug in Sweden and subsidized for patients with chronic kidney disease in stages 3 to 5, with or without chronic heart failure, for whom treatment with Resonium is not suitable and for patients with chronic heart failure without con-comitant chronic kidney disease
15758497|NCT04789239|Other|Placebo|Treatment with the same dose of placebo medicine as they would have received had they been treated with the interventional drug (SZC).
15758498|NCT04789213|Other|Liver Transplantation|Liver Transplantation
15758499|NCT04789200|Drug|NX9 Oral Contrast Agent|Distension and marking of the bowel lumen will be compared between the 1st and 2nd scan. Ability to see IV contrast enhancement will be assessed on the 3rd scan in relationship to the 2nd scan.
15758500|NCT04789187|Procedure|High-Intensity-Interval-Training|Defined exercise program up to four times per week including high-intensity-interval-training for one year of active study intervention.
15758501|NCT04789187|Procedure|General Physical Activity Recommendations|Patients will be given general physical activity recommendations during chemotherapy.
15758542|NCT04788823|Drug|Prednisone|Treatment groups will be administered different dosages of Prednisone post vasectomy reversal.
15758507|NCT04789135|Drug|Ozone|Treatment consists of direct instillation into the bladder of ozone gas, with concentration of 20µg / ml - 60ml via urethral catheter.
15758508|NCT04789122|Other|Attitude assessment|The study covered a representative group of 1000 people. Own questionnaire and standardized tools sent online via the Statistical Research and Analysis Office, in compliance with the privacy policy and personal data protection of the General Data Protection Regulation.
15758509|NCT04789109|Combination Product|Capecitabine tablets + temozolomide tablets + SIR-Spheres|see arm description
15758510|NCT04789096|Drug|Tucatinib|Oral tablet
15758511|NCT04789096|Drug|Pembrolizumab|Intravenous
15758512|NCT04789096|Drug|Trastuzumab|Intravenous
15758513|NCT04789096|Drug|Capecitabine|Oral tablet
15758514|NCT04789083|Other|Propholis extrate|Plassebo
15758515|NCT04789070|Drug|Sirolimus|Sirolimus is a currently licensed drug primarily used for immunosuppression post-kidney transplantation to prevent organ rejection. Sirolimus was initially considered as a treatment in IBM for its immunosuppressive action and beneficial effects in an experimental myositis mouse model.(11) Transfer of effector T cells from affected to healthy animals resulted in myositis, but the presence of Treg cells were protective against development of myositis. As Sirolimus, which acts to deplete effector T cells but preserving the Treg cells, was effective in this mouse model of myositis, it was therefore postulated that it may also be effective in IBM, not only for its effects on effector T cells and Treg cells, but also for its additional effects on protein degradation.
15758516|NCT04789070|Drug|Placebo|Placebo
15758517|NCT04789057|Drug|Atorvastatin 40 Mg Oral Tablet|p.o., once daily
15758518|NCT04789057|Drug|Placebo|p.o., once daily
15758519|NCT04789044|Drug|NTX-001|• PEG fusion is the application of a polyethylene glycol (PEG) using a combination of sequenced reagents to a freshly performed nerve coaptation, or neurorrhaphy, to allow the axonal membranes of the proximal and distal axonal stumps to fuse back together and re-establish full axonal continuity.
15758520|NCT04789031|Dietary Supplement|Oral nutritional supplementation (ONS)|Patients received a renal specific ONS (Novasource Renal, Nestle) providing 475 kcal and 21.7g of protein per serving on a daily basis for 6 months. This was a ready-to- drink formula available in a tetrabrik pack. Patients consumed the product 30 minutes after commencing their dialysis session or at home after completion of dialysis.
15758521|NCT04789018|Other|Educational Intervention|Attend virtual genetics board
15758522|NCT04789018|Other|Survey Administration|Complete survey
15758523|NCT04789018|Other|Interview|Complete interview
15758524|NCT04789005|Drug|Norepinephrine|Norepinephrine 8mcg was administered manually by the anaesthesiologist every time the SBP was 20% lower than baseline and the HR ≥60 bpm.
15758525|NCT04789005|Drug|Phenylephrine|Phenylephrine 100mcg was administered manually by the anaesthesiologist every time the SBP was 20% lower than baseline and the HR ≥60 bpm.
15758526|NCT04788992|Other|Intervention group|Dementia care training consists of dementia care e-books, dementia virtual reality activity and peer support program.
15758527|NCT04788992|Other|Control group|Dementia care training consists of dementia care e-books and peer support program without dementia virtual reality activity
15758528|NCT04788979|Drug|Melatonin 5Mg Oral Tablet|"control without treatment
~obese periodontitis patients treated only by scaling and root planning
~obese periodontitis patients treated with scaling and root planning with daily dietary supplementation of 5 mg melatonin (NOW-USA)"
15758529|NCT04788966|Device|the translation tool BabelDr|Doctors use a speech-enabled fixed-phrase translation tool to help communicate with an allophone patient.
15758530|NCT04788953|Drug|Solriamfetol Oral Tablet|The administered drug is SUNOSI (solriamfetol) tablets for oral use. Initial U.S. Approval: 2019
15758531|NCT04788953|Drug|Placebo|Control subjects will receive placebo tablets for oral use.
15758532|NCT04788940|Procedure|Percutaneous Coronary Intervention|Patients with AMI who underwent PCI and CMR at index hospitalization and 6-month follow-up
15758533|NCT04788914|Dietary Supplement|Active bamboo charcoal± probiotics|Active bamboo charcoal 2g, TID probiotics 0.8g
15758534|NCT04788901|Other|REThink therapeutic game|REThink is a online therapeutic game developed by David and collaborators (2018), proved to be an efficient intervention to reduce emotional symptoms of children and adolescents.
15758535|NCT04788888|Device|Navitor Transcatheter Aortic Valve and FlexNav Delivery System|"For traditional application, the Navitor valve is indicated for transcatheter delivery in patients with symptomatic severe native aortic stenosis who are intermediate or low surgical risk.
~For the valve-in-valve application, the Navitor valve is indicated for use in patients with symptomatic heart disease due to failure (stenosed, insufficient, or combined) of a surgical bioprosthetic aortic valve.
~Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Navitor valve and FlexNav Delivery system"
15758536|NCT04788875|Procedure|Small bite suturing Technique|Small bite suturing technique with PDS 2.0
15758537|NCT04788875|Procedure|Standardised Large Bites Technique|Standardised large bite suturing technique with PDS 2.0
15758538|NCT04788862|Biological|P. falciparum infected erythrocytes|Chloroquine sensitive P. falciparum 3D7-infected red blood cells, thawed and prepared under strict aseptic conditions, will be used as a challenge agent.
15758539|NCT04788849|Diagnostic Test|BD Onclarity™ HPV assay|Women will be asked to self-collect first-void urine using Copan's UriSponge™ 8E031S100 and vaginal swabs using Copan's FLOQSwabs® 5E089N. All samples will be tested with BD Onclarity™ HPV assay. HPV test results on self-collected samples will be compared to those obtained when testing clinician-collected cervical sample
15758540|NCT04788836|Other|Questionnaire (Survey and Food Frequency Questionnaire (FFQ))|Each participant will be asked to fill a web-based questionnaire that captures sociodemographic, lifestyle, physical and mental health information (Survey) and dietary intake patterns (FFQ). This will be done pre-surgery (only for those included pre-surgery), 6 months post-surgery, 1 year post-surgery and then yearly until 5 year post-surgery.
15758541|NCT04788836|Other|Collection of digital receipts from grocery shopping|"Participants will create their BitsaboutMe-account (GDPR-compliant data sharing platform from Bern, Switzerland) with the help of study team members. Data from digital receipts will be obtained from Migros Cumulus and Coop Supercard via their BitsaboutMe-account. The data collection allow retrospective digital receipts collection for up to 2 years and automatically continuous collection during study duration.
~GDPR: General Data Protection Regulation"
15758546|NCT04788771|Procedure|Tracheal intubation in laparoscopic extraperitoneal hernia repair|laryngeal mask airway in laparoscopic extraperitoneal hernia repair
15758547|NCT04788758|Other|Educational Intervention|Receive G8 screening tool administration training
15758548|NCT04788758|Other|Screening Questionnaire Administration|Complete G8 screening tool
15758549|NCT04788758|Other|Referral|Receive referral
15758550|NCT04788758|Other|Questionnaire Administration|Ancillary studies
15758551|NCT04788745|Drug|Trimetazidine Dihydrochloride|Oral tablet, twice-daily
15758552|NCT04788732|Device|ECG and EEG monitoring|the ECG and EEG will also be monitored during the entire period that the patients remain anesthetized with various anesthetics drugs and will later be used to compose the DoA score based on HRV.
15758553|NCT04788719|Other|Gait analysis|Gait analysis
15758554|NCT04788706|Other|Low level Laser Therapy and Russian electrical stimulation|LLLT over three weeks followed by an eight-week receiving Russian electrical stimulation
15758555|NCT04788706|Other|Placebo Laser and Russian electrical stimulation|Placebo laser over three weeks followed by an eight-week receiving Russian electrical stimulation
15758556|NCT04788706|Other|Low level Laser Therapy and Low level Laser Therapy plus Russian electrical stimulation|LLLT over three weeks followed by an eight-week receiving LLLT application combined with Russian electrical stimulation
15758557|NCT04788706|Other|Placebo Laser and Placebo Laser plus Russian electrical stimulation|Placebo laser over three weeks followed by an eight-week receiving Placebo laser application combined with Russian electrical stimulation
15758558|NCT04788693|Other|Physical rehabilitation of gait with motor imagery|Physical rehabilitation of gait is a type of non-invasive treatment that seeks to change the way of performing a task or motor function (in this case, gait) through movement modification and corrected repeated practice, taking into account the alterations, limitations and considerations related to the disease suffered by the person. In this intervention, in addition to physical exercise to correct gait, mental exercises will be included in which the patient visualizes himself performing the exercises that he will then develop with the body.
15758559|NCT04788693|Other|Physical rehabilitation of gait without motor imagery|Physical rehabilitation of gait is a type of non-invasive treatment that seeks to change the way of performing a task or motor function (in this case, gait) through movement modification and corrected repeated practice, taking into account the alterations, limitations and considerations related to the disease suffered by the person. Motor imagery exercises are not included in this program.
15758560|NCT04788680|Other|Dietary intervention 1|Participants receive a beverage with a defined amount of non-nutritive sweetener.
15758561|NCT04788680|Other|Dietary Intervention 2|Participants receive a beverage with a defined amount of non-nutritive sweetener and maltodextrin.
15758562|NCT04788680|Other|Dietary Intervention 3|Participants receive a beverage with a defined amount of monosaccharide.
15758563|NCT04788680|Other|Dietary Intervention 4|Participants receive a beverage with a defined amount of disaccharide.
15758564|NCT04788667|Other|A health education programme using a telerehabilitation platform|All patients enrolled in the study will receive information through the tele rehabilitation platform, although the experimental group will have specific training/education whereas the control group will only receive some general recommendations as control/sham
15758565|NCT04788654|Drug|Celebrex, acetaminophen, and dexamethasone|Pharmacological intervention will be performed. Celebrex 200mg, acetaminophen 1g, and dexamethasone 7 mg will be infused perioperatively.
15758566|NCT04788654|Procedure|Saline irrigation, aspiration of pneumoperitoneum, and low pressure penumoperitoneum|Surgical intervention will be performed. Saline irrigation, aspiration of pneumoperitoneum, and low pressure pneumoperitoneum will be performed.
15758567|NCT04788641|Drug|Tacrolimus|Each subject in this cohort will receive a single dose of oral capsules of tacrolimus on 2 occasions, once alone and once in combination with oral suspension of SZC. Drug administrations will occur after a 12 hour overnight fast.
15758568|NCT04788641|Drug|Cyclosporin|Each subject will receive a single dose of oral capsules of cyclosporin on 2 occasions, once alone and once in combination with oral suspension of SZC. Drug administrations will occur after a 12 hour overnight fast.
15758569|NCT04788641|Drug|Sodium Zirconium Cyclosilicate|Each subject will receive single oral doses of SZC with tacrolimus (cohort 1) or cyclosporin (cohort 2) under fasted conditions. The doses will be administered after an overnight fast of at least 12 hours.
15758570|NCT04788628|Other|Baseline|Hippocampal and scalp EEG monitoring during overnight sleep
15758571|NCT04788628|Other|Motor procedural memory task|Training on the finger tapping MST prior to monitored overnight sleep with MST testing the following morning
15758572|NCT04788628|Other|Motor procedural memory task plus auditory stimulation|Training on the finger tapping MST prior to monitored overnight sleep that includes auditory stimulation, with MST testing the following morning
15758573|NCT04788615|Drug|Ofatumumab|20mg Subcutaneous injection
15758574|NCT04788615|Drug|First line DMT|any one of these based on availability at country given as First line DMT Glatiramer acetate 20mg or 40mg or Interferon 22µg or 0.25mg or Teriflunomide 14mg or Dimethyl fumarate 240mg or 480mg
15758575|NCT04788589|Other|Sedation and ventilator weaning protocol|Subjects randomized to this group will underwent sedation and ventilator weaning protocol as mentioned before.
15758576|NCT04788576|Diagnostic Test|Invasive physiologic evaluation (fractional flow reserve, coronary flow reserve, index of microcirculatory resistance)|In case of heart failure with preserved ejection fraction confirmed by HFA-PEFF scoring system without functionally significant coronary artery disease, coronary angiography with invasive physiologic evaluation including fractional flow reserve, coronary flow reserve, and index of microcirculatory resistance will be performed to evaluate the distribution and clinical implication of coronary microvascular dysfunction.
15758577|NCT04788563|Other|Heat-sensitive moxibustion plus original antihypertensive treatment (compulsively randomized arm)|In this group, patients will self-administer heat-sensitive moxibustion or have family members help with the administration for six months. During this period, they will maintain their original antihypertensive treatment.
15758578|NCT04788563|Drug|Original antihypertensive treatment (compulsively randomized arm)|In this group, patients will maintain their original antihypertensive treatment.
15758579|NCT04788563|Other|Heat-sensitive moxibustion plus antihypertensive treatment (voluntarily randomized arm)|In this group, patients will self-administer heat-sensitive moxibustion or have family members help with the administration for six months. During this period, they will maintain their original antihypertensive treatment.
15758580|NCT04788563|Drug|Original antihypertensive treatment (voluntarily randomized arm)|In this group, patients will maintain their original antihypertensive treatment.
15758581|NCT04788563|Other|Heat-sensitive moxibustion plus original antihypertensive treatment (preference selection arm)|In this group, patients will self-administer heat-sensitive moxibustion or have family members help with the administration for six months. During this period, they will maintain their original antihypertensive treatment.
15758582|NCT04788563|Drug|Original antihypertensive treatment (preference selection arm)|In this group, patients will maintain their original antihypertensive treatment.
15758586|NCT04788537|Behavioral|Training to Understand and Navigate Emotions and Interactions (TUNE In)|A three-part cognitive behavioral treatment strategy to improve social functioning in adults with autism spectrum disorder. TUNE In includes components to address the many behavioral domains involved in social functioning, including social motivation, social anxiety, social cognition, social skills, and generalization of the skills to community settings.
15758587|NCT04788524|Behavioral|Computer Task Manipulation|Participants will complete computer tasks.
15758590|NCT04788498|Procedure|Laparoendoscpoic single site surgery LESS|• A SILS Port (Covidien®) with three access inlets will be inserted into the abdominal cavity using a Heaney clamp
15758591|NCT04788498|Procedure|Conventional multiport laparoscopy|• It will be performed using a three-port system using a closed technique on the umbilicus, left and right lower quadrant area.
15758592|NCT04788485|Drug|Diosmectite|use of diosmectite as a food thickener in neonates in with gastroesophageal reflux in noenates
15758593|NCT04788472|Drug|CAR-T cells targeting CD19 and CD22|Each subject receives sequential CD19 and CD22 CAR-T cells by intravenous infusion
15758594|NCT04788459|Biological|COVID-eVax|Plasmid DNA Vaccine for COVID-19
15758595|NCT04788459|Device|Cliniporator® and EPSGun|IGEA Electroporation Device
15758596|NCT04788446|Behavioral|Mini-flipped Game-based Learning|The intervention was 8 weeks, forty minutes adjusted Mediterranean diet learning plan once a week, which includes the 20 minutes for the Mediterranean food table game, and the 20 minutes for the Mediterranean diet nutrition course. The topic of the course includes the relationship between Mediterranean diet and dementia, knowledge of Mediterranean diet, how to integrate local food ingredients into the Mediterranean diet, etc.
15758597|NCT04788446|Behavioral|Balanced diet|Given a balanced diet nutrition health education manual for the aged.
15758598|NCT04788433|Diagnostic Test|glycomic analysis|Analysis of glycans on plasma samples
15758599|NCT04788433|Other|Phone interview|patients are followed up by phone up to 1 year
15758600|NCT04788420|Drug|Sorafenib|The initial dose of sorafenib is 400 mg orally twice daily and is adjusted in case of suspected toxicity or resistance (dose range, 200-800 mg daily).
15758601|NCT04788407|Drug|Nitazoxanide|Subjects will receive nitazoxanide 500 mg TID for 7 days
15758602|NCT04788407|Drug|Placebo|Subjects will receive placebo TID for 7 days
15758603|NCT04788394|Other|To determine the prevalence of renal dysfunction in hospitalized children with COVID19 in Qatar.|In this retrospective study, the investigators will include all children (age 0-14 years) with COVID-19 admitted to Hamad General Hospital, pediatric division- Doha, Qatar from March 1, 2020, till January 1, 2021, diagnosed by a positive PCR result. they will look for renal abnormalities, specifically at acute kidney injury. Diagnosing acute kidney injury in children is challenging as serum creatinine varies with age and is dependent on muscle mass. investigators therefore referenced serum creatinine values for our sample against the age-specific upper limit of reference interval (ULRI) values according to Hamad Hospital guidelines. Acute kidney injury will be defined as a serum creatinine 1.5 times greater than the ULRI.
15758604|NCT04788381|Drug|Bevacizumab|Enrolled patients may be eligibled if bevacizumab was discontinued within 6 weeks prior to unexpected operation.
15758605|NCT04788368|Procedure|Surgical resection|Surgical resection with either of the above mentioned techniques
15758606|NCT04788355|Drug|Control group (standard hospital treatment)|Medications defined by the hospital involved in the study
15758607|NCT04788355|Drug|Group Hydroxychloroquine|Patients in this group will receive hydroxychloroquine orally 200 mg every 12 hours for 7 days. In addition, patients in this group will receive standard medication for COVID-19 which is part of the hospital protocol involved in the study.
15758608|NCT04788355|Drug|Group Hydroxychloroquine and apixaban|Patients in this group will receive hydroxychloroquine orally 200 mg every 12 hours for 7 days + apixaban orally 2.5 mg every 12 hours, also for 14 days (prophylactic dose). In addition, patients in this group will receive standard medication, which is the protocol of the hospital involved in the study.
15758609|NCT04788355|Drug|Group Apixaban|Patients in this group will receive apixaban 2.5 mg orally every 12 hours, also for 14 days (prophylactic dose). In addition, patients in this group will receive standard medication, which is the protocol of the hospital involved in the study.
15759030|NCT04784832|Device|Transcranial magnetic stimulation|Magnetic stimulation of the cortex
15758610|NCT04788342|Device|pulse wave recording, echocardiography.|pulse wave recording using a single-channel electrocardiogram cardiomonitor with photoplethysmography, conducting echocardiography according to a standard protocol with the determination of systolic function of the left ventricle
15758611|NCT04788329|Behavioral|"Prepare for Surgery, Heal Faster Program"|This NYU program teaches patients how to feel calmer before surgery. Patients are taught relaxation techniques by phone or in person by trained NYU personnel. The program uses five steps to ease stress-related symptoms prior to surgery and improve help recovery time. By practicing deep relaxation, it is possible to reduce anxiety and promote a feeling of calmness. The patient swill be enrolled in the course preoperatively and will be ask to continue these meditations for ten weeks.
15758612|NCT04788329|Behavioral|Wim Hof Method|Patients will be enrolled in Wim Hof Method, a breathing/meditation program. This is a free online program, developed by a man named Wim Hof and his techniques. On this website, he explains the origins and methods behind his teachings ( https://www.wimhofmethod.com/iceman-wim-hof. ). Patients in this group will take the online free course provided by the Wim Hof Method. The patients will be introduced to the online course preoperatively. The three pillars of the WHM are 1) breathing/meditation, 2) stretching exercises and 3) gradual cold exposure. The patients will be told to concentrate on the breathing and meditation component, they may not be able to participate in the cold exposure (cold showers, ice baths) in the immediate post op period because of the open wounds.
15758613|NCT04788316|Behavioral|CBI and Text messaging|A computerized brief intervention (2 sessions) followed by six months of personalized text messaging
15758616|NCT04788290|Other|Observational|Rabone D®, Once daily administered per the locally approved product information
15758617|NCT04788277|Procedure|Biospecimen Collection|Undergo collection of urine samples
15758618|NCT04788264|Other|Medical Device Usage and Evaluation|Receive Fitbit
15758619|NCT04788264|Other|Consultation|Receive consultation from a physical therapist
15758620|NCT04788264|Other|Exercise Intervention|Attend exercise training sessions
15758621|NCT04788264|Behavioral|Behavioral Intervention|Attend sessions with a behavioral therapist
15758622|NCT04788264|Other|Questionnaire Administration|Ancillary studies
15758623|NCT04788264|Other|Quality of Life Assessment|Ancillary studies
15758626|NCT04788238|Behavioral|Dual-Task Zumba Gold|Dual-Task Zumba Gold is a 12-week program to be conducted thrice weekly for 45-60 minutes. The intervention involves the concurrent performance of cognitive tasks and physical movements during specific parts of the dance. The activity will begin with warm-up and end with cool-down periods, at 5 to 10 minutes each. Orientation training will be done during the warm-up period, by asking questions to participants about time, place, and person. In the actual dance (30 to 40 minutes), the following domains will be trained: executive function (forward and backward serial counting); perceptual-motor ability (performing arm clock positions based on instructions); memory (forward and backward repetition of number/word series), and attention (forward and backward spelling of 3- to 5-letter words). The cool-down period will incorporate memory training by reminding the participants to summarize the activities performed.
15758627|NCT04788225|Other|Balance assessment|"Static balances will be measured with the Biodex-BioSway 950-462 static balance device according to 3 different standard test procedures (Postural Stability Test, Stability Limit Test and Modified Sensori Organization Test) in single foot stance and double foot stance.
~Dynamic balances will be evaluated with the Y balance test."
15758628|NCT04788225|Other|Functionality assessment|Functionality will be evaluated with the Lower Extremity Functional Scale and AOFAS (American Orthopedic Foot and Ankle Society Ankle-Hindfoot Scale)
15758629|NCT04788225|Other|Performance assessment|Performance evaluation will be made with a single leg jump test and time up and go test.
15758630|NCT04788225|Other|ROM assessment|Range of motion (ROM) of the ankle will be measured with an electrogonyometer in dorsi-plantar flexion.
15758631|NCT04788212|Behavioral|Group Behavioral Activation Therapy for Autism Spectrum Disorder|This will be a modification of the Group Behavioral Activation Therapy program (Chu et al., 2009) for treatment of depression, anxiety and/or anger in autistic adults.
15758632|NCT04788199|Other|Closure of mesenteric defects using glue|Cyano-acrylate glue is a glue known to be used in surgery as tissue adhesive.
15758633|NCT04788186|Drug|De-prescribe beta blocker therapy|"Participants will be de-prescribed for beta-blocker therapy.
~De-prescription will be performed as follows:
~Half of pre-randomization dose for the first 3 days, then
~Half of the above dose for the next 3 days, then discontinue"
15814017|NCT04333979|Other|Drainage|Using drain after operation
15758634|NCT04788160|Other|Cervical SNAGs along with conventional therapy|"cervical SNAG half rotation technique will be performed with the patient sitting on a chair in the erect posture. The therapist placed his thumb over thumb over the transverse process of C1. Then, he glided ventrally with active rotation of the restricted site 10 times holding for 10 seconds with overpressure at end of the rotation with 30 second rest in between each repetition and 3 session/week for 4 weeks.
~Conventional therapy will include:
~Hot pack over the cervical region for 10 minutes.
~TENS for 10 minutes.
~Furthermore, general stretching the upper cervical muscles will be done with 5 repetitions with 3 sessions/week for 4 weeks.
~Isometric cervical extensor exercise with 10 seconds hold for 10 times will be done.
~Cervical flexor strengthening will be done 10 times in sitting position."
15758635|NCT04788160|Other|Conventional Therapy|"Patients in this group will undergo only conventional therapy which will include:
~Hot pack for 15 minutes.
~TENS for 10 minutes.
~Furthermore, general stretching the upper cervical muscles will be done with 5 repetitions each 3 sessions/week for 4 weeks.
~Isometric cervical extensor exercise with 10 seconds hold for 10 times will be done.
~Cervical flexor strengthening will be given to the patient by the therapist, 10 times in sitting position."
15758636|NCT04788134|Diagnostic Test|Post-rotatory nystagmus test|The test is administrated with the person sit down with cross legs at a rotatory board, with the head positioned by the examiner in 30° of forward flexion. The position was maintained by the administration of the test. The administration consist in two administrations separate by one minute. Each administration consist in rotate the person 10 times in 20 seconds (the first 10 rotations in a counterclockwise direction in 20 s and the second 10 rotations in a clockwise direction in 20 s). After each administration the examiner counts the duration of the reflex in seconds.
15758637|NCT04788121|Drug|Tranexamic acid|The treatment group will receive Injection TXA 1gm intravenous (IV) over 15 minutes infusion dissolved in 100 ml normal saline (NS- 0.9% NaCl), followed by injection TXA 2 g IV over 12 hours infusion dissolved in a 500 ml NS
15758638|NCT04788121|Other|Standard of care|For management, initial priority will be given to secure airway, breathing and circulation. To ensure hemodynamic stability, crystalloids infusion will be given as and when required. Blood transfusion will be initiated at the threshold hemoglobin (Hb) of 7g/dl, to maintain the target Hb of 7-9g/dl or with signs of hemodynamic instability despite fluid resuscitation. Intra venous (IV) PPI and antibiotic will be started promptly in all cases and IV splanchnic vasoconstrictor will be given in all suspicious case of Variceal hemorrhage before definitive therapeutic and diagnostic endoscopic procedure is done.
15758639|NCT04788108|Drug|Dydrogesterone|Dydrogesterone tablet
15758640|NCT04788108|Drug|Placebo|Placebo tablet
15758641|NCT04788095|Behavioral|Behavioral Intervention|Participate in an app-based mindfulness program
15758642|NCT04788082|Diagnostic Test|3D Printed Heart Model|Prior to surgical intervention, the surgeon will be exposed to clinically-indicated images and a patient-specific 3D printed model of the subject's heart anatomy.
15758643|NCT04788069|Dietary Supplement|Wholemeal bread|180g wholemeal bread/day + fixed portion at test day
15758644|NCT04788069|Dietary Supplement|Sourdough bread|180g sourdough bread/day + fixed portion at test day
15758645|NCT04788069|Dietary Supplement|Bread with sourdough|180g bread with sourdough/day + fixed portion at test day
15758646|NCT04788056|Procedure|Parasternal Subpectoral Plane Block|Nerve block catheter inserted into plane between rib cartilages and pectoralis muscle.
15758647|NCT04788043|Drug|Magrolimab|200 mg max, starting 1 mg/kg IV Infusion
15758648|NCT04788043|Drug|Pembrolizumab|200 mg IV infusion
15758649|NCT04788043|Procedure|PET/CT|Scan
15758650|NCT04788030|Other|Nerve reconstruction|Nerve bridging with muscle-in-vein conduits
15758651|NCT04788017|Drug|Ziresovir|"Planned treatments are:
~Cohort 1: 300 mg of ziresovir
~Cohort 2: up to 600 mg of ziresovir
~Cohort 3: up to 900 mg of ziresovir"
15758652|NCT04788017|Other|Placebo|"Planned treatments are:
~Cohort 1: 300 mg of placebo
~Cohort 2: up to 600 mg of placebo
~Cohort 3: up to 900 mg of placebo"
15758654|NCT04787991|Drug|Nivolumab (Cohort A)|Nivolumab will be administered intravenously every 3 weeks for up to 2 years.
15758655|NCT04787991|Drug|Ipilimumab (Cohort A and B)|Ipilimumab will be administered intravenously every 6 weeks for up to 2 cycles.
15758656|NCT04787991|Drug|Hydroxychloroquine (HCQ) (Cohort B)|Hydroxychloroquine will be administered orally daily for up to 2 years.
15758657|NCT04787991|Drug|Nab-paclitaxel (nP) (Cohort A and B)|Nab-paclitaxel will be administered intravenously at 125 mg/m2 for 2 weeks on and 1 week off, for at least 24 weeks, unless treatment discontinuation criteria are met.
15758658|NCT04787991|Drug|Gemcitabine (gem) (Cohort A and B)|Gemcitabine will be administered intravenously at 1000 mg/m2 for 2 weeks on and 1 week off, for at least 24 weeks, unless treatment discontinuation criteria are met.
15758659|NCT04787978|Other|Physical Activity and Education Intervention|"The intervention involves peer teams, health coaches and community health workers [CHW]. Each participant will be assigned to a CHW and grouped into a team of 10-20 participants based on participant proximity to a Columbus Recreation and Parks Center. Each team will be assigned 4 health coaches, 2 medical students, 1 undergraduate student and 1 nursing student from OSU Health Sciences Colleges.
~The lifestyle intervention is 24 weeks consisting of 1 hour and 15 minutes of in person training time per week. The training time consists of 45 minutes of physical activity and 30 minutes of educational content was informed by evidence-based strategies and stakeholder feedback.
~Health coaches will implement the curriculum based on the Diabetes Prevention Program and the American Heart Association Check, Change, Control Program and develop team-based SMART (specific, measurable, achievable, relevant, and time-bound) wellness goals."
15758660|NCT04787965|Drug|Opicapone|Opicapone as adjunctive treatment to levodopa/carbidopa over a 6-month period
15758661|NCT04787952|Other|cold expossure|subjects were exposed for the cold, to activate and diagnose potential brown tissue activity
15758662|NCT04787939|Behavioral|Early Feeding|Subjects will be permitted to drink liquids by mouth on the first day after surgery. Outcomes related to their care, wound healing, and quality of life will be followed for 30 days after surgery.
15758775|NCT04786964|Dietary Supplement|Vitamin B12 1000 μg|Intramuscular injection in the week preceding the first dose of pemetrexed and once every 3 cycles thereafter. Subsequent vitamin B12 injections may be given the same day as pemetrexed administration.
15758663|NCT04787926|Device|Locking Solution|The total duration of the study treatment period will be 90 calendar days, from Visit 1 Pre-Instillation to the last study-related assessment. Two to 3 instillations (1 per lumen per visit) of DuraLock-C 4.0%, 30.0%, or 46.7% (equivalent to the catheter manufacturer's prescribed priming volume) will be instilled 1 to 3 days apart (with a HD schedule of 3 to 4 times per week); each instillation of CLS will remain in the CVC for approximately 24 to 72 hours ± 12 hours, based on their practice preferences. EOS will take place at the patient's next scheduled dialysis session.
15758664|NCT04787913|Behavioral|herdimm|In this visualization participants can build their own avatar representing themselves and 8 other avatars representing people around them, like their family or coworkers. Our visualization then uses these avatars in a brief narrated video explaining how herd immunity works.
15758665|NCT04787913|Behavioral|guardianmeasles|A screen capture of an interactive visualization: https://www.theguardian.com/society/ng-interactive/2015/feb/05/-sp-watch-how-measles-outbreak-spreads-when-kids-get-vaccinated
15758666|NCT04787913|Behavioral|theotheredmundmeasles|A gif showing measles spreading through populations with differing levels of vaccine coverage: https://imgur.com/gallery/8M7q8#J7LANQ4
15758667|NCT04787913|Behavioral|sbsnewsgeneric|A video showing how herd immunity works in general: https://www.sbs.com.au/news/two-sydney-babies-too-young-to-be-vaccinated-infected-with-measles
15758668|NCT04787913|Behavioral|publichealthagencycanadaflu|A video showing how herd immunity works in the context of influenza: https://www.canada.ca/fr/sante-publique/services/video/la-grippe-n-en-passez-pas-les-maux.html
15758669|NCT04787913|Behavioral|robertkochgeneric|A web-based application showing how herd immunity works in general: http://rocs.hu-berlin.de/D3/herd/
15758670|NCT04787900|Device|iPhone measurement application|The iPhone measurement application will be used to ensure validity and reliability.
15758671|NCT04787900|Device|Bubble inclinometer|Bubble inclinometer with proven validity and reliability will be used for this study.
15758672|NCT04787887|Drug|Abcertin|60IU/kg Single Intravenous Administration
15758673|NCT04787887|Drug|EU-sourced Cerezyme|60IU/kg Single Intravenous Administration
15758674|NCT04787874|Behavioral|Prehabilitation Program|"Nutrition component: Participants will receive information on how to follow a healthy diet (Mediterranean-style diet) with emphasis on whole foods, plants, lean protein, olive oil; restriction of red meats, processed meats, processed foods, added sugar)
~Exercise component: Participants will receive an activity tracker to use during the study period (3+ weeks before surgery, and 30 days after surgery). Participants will be assigned strength exercises to work on core strength and proximal muscle strength (biceps/triceps, quads, hamstrings, calves).The exercises will mainly be focused on strengthening the abdominal wall. Exercises will be tailored to patients' individual capabilities. They will also be assigned cardio exercises - either low-intensity steady state cardio vs High Intensity Interval training. Level of cardio exercise will be tailored based on patient's Duke Activity score and baseline activity."
15758675|NCT04787861|Other|motorized movement therapy|The study group received an aerobic exercise regimen using a motorized movement therapy device 3 times /week in addition to the same traditional program used with the control group.
15758676|NCT04787848|Drug|Relistor Injectable Product|Relistor is a peripherally acting opioid receptor antagonist approved by the FDA for relief of opioid-induced constipation
15758677|NCT04787835|Procedure|Forearm nerve block|Local anesthesia will be used to perform a forearm block of the median, radial, and ulnar nerves.
15758678|NCT04787835|Procedure|Local anesthetic infiltration|Local anesthesia will be infiltrated at the site of injury
15758679|NCT04787809|Behavioral|Living Well|Living Well is a single session digital intervention that aims to decrease experiential avoidance and increase engagement in values-consistent behavior.
15758680|NCT04787796|Device|a 28-channel ECG (MECG) system|To test if a 28-channel ECG (MECG) system would efficiently differentiate the patients suspected to have CAD or ACS with acceptable sensitivity and specificity, and optimize this portable self-built-in multichannel ECG recorder system with various algorithms.
15758681|NCT04787783|Other|Web based preoperative assessment|Preoperative assessment conducted through a web based application
15758682|NCT04787770|Other|non-intervention|non-intervention
15758683|NCT04787757|Procedure|Percutaneous cardiac procedure|Collection and analysis of intraprocedural information to provide artificial intelligence algorithms
15758684|NCT04787744|Procedure|PET-directed Local Therapy using Surgery|Surgery will be used to treat metastases.
15758685|NCT04787744|Radiation|PET-directed Local Therapy using Radiation|"Radiation therapy will be used to treat metastases.
~Radiation options include:
~Stereotactic body radiotherapy (SBRT) using 1-10 fractions
~Conventionally fractionated radiotherapy using elective nodal radiotherapy and a simultaneous integrated boost to involved nodes
~The selection of the form of metastasis-directed radiotherapy for each metastasis will be determined using shared decision-making between the treating physician and the Veteran."
15758686|NCT04787744|Other|Salvage Local Therapy for locally recurrent disease|For Veterans who have a local recurrence in addition to oligorecurrent metastatic lesions, they will undergo salvage local therapy using brachytherapy, SBRT, surgery, cryotherapy or HIFU. The selection of modality of salvage local therapy will be determined using shared decision-making between the treating physician and Veteran.
15758687|NCT04787744|Drug|Goserelin, Histrelin, Leuprolide & Triptorelin|Androgen deprivation therapy (ADT) using an LHRH agonist
15758688|NCT04787744|Drug|ADT + Nilutamide, Flutamide, & Bicalutamide|ADT adding anti-androgen therapy to an LHRH agonist
15758689|NCT04787744|Drug|Degarelix|ADT using an LHRH Antagonist.
15758690|NCT04787744|Drug|ADT + Docetaxel +/- prednisone|Enhanced SST using chemohormonal therapy
15758691|NCT04787744|Drug|ADT + Abiraterone + Prednisone|Enhanced SST using Abiraterone + Prednisone
15758692|NCT04787744|Drug|ADT + Abiraterone + Methylprednisolone|Enhanced SST using Abiraterone + Methylprednisolone
15758693|NCT04787744|Drug|ADT + Apalutamide|Enhanced SST using ADT + Apalutamide
15758694|NCT04787744|Drug|ADT + Enzalutamide|Enhanced SST using ADT + Enzalutamide
15758695|NCT04787731|Drug|Bupivacaine Local Anesthetic|Long lasting local anesthetic administered to be compared to Lidocaine for quality of life outcomes in dental patients undergoing endodontic treatment
15758696|NCT04787718|Other|Almond|2.0 oz of raw, shelled, unsalted almonds
15758697|NCT04787718|Other|Control group|an isocaloric amount of unsalted pretzels
15817911|NCT04302064|Drug|AKCEA-TTR-LRx|AKCEA-TTR-LRx administered SC
15758698|NCT04787692|Behavioral|Opioid and Benzodiazepine Naive-patients|Duration of treatment : 1 month Lucid Lane is a service that will be used by patients scheduled for elective orthopedic or neurosurgical spine surgery that will incorporate continuous MEASUREMENT & MONITORING, PERSONALIZED TREATMENT PLANNING and REAL-TIME INTERVENTIONS (MPI) as the patient is tapering off of opioids and/or benzodiazepines. Patients will participate in the Lucid Lane program.Daily support will include 1 or more from the following: Therapist chat, and/or audio psychotherapy sessions, and/or group therapy sessions, Cognitive behavioral therapy(CBT), Mindfulness, and/or peer support. Patients will submit a weekly survey and the therapist will submit weekly reports to the physician.
15758699|NCT04787692|Behavioral|Opioid and Benzodiazepine Tolerant-patients|Duration of treatment : 6 months Lucid Lane is a service that will be used by patients scheduled for elective orthopedic or neurosurgical spine surgery that will incorporate continuous MEASUREMENT & MONITORING, PERSONALIZED TREATMENT PLANNING and REAL-TIME INTERVENTIONS (MPI) as the patient is tapering off of opioids and/or benzodiazepines. Patients will participate in the Lucid Lane program.Daily support will include 1 or more from the following: Therapist chat, and/or audio psychotherapy sessions, and/or group therapy sessions, CBT, Mindfulness, and/or peer support. Patients will submit a weekly survey and the therapist will submit weekly reports to the physician.
15758700|NCT04787679|Procedure|Hip replacement surgery|After hip replacement surgery the sponsor obtains femoral head samples for the study
15758701|NCT04787666|Procedure|Using of non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) and non-invasive ventilation with a helmet|Using of non-invasive mask ventilation, high-flow oxygen therapy through a nasal cannula (high-flow nasal oxygenation) and non-invasive ventilation with a helmet for tackling the problem of respiratory failure
15758702|NCT04787653|Device|Otoband|Participants with Tinnitus will wear the Otoband set at an effective power level during a 30 minute time frame and outcome measurements will be recorded in a Google Form.
15758703|NCT04787653|Device|Placebo|Participants with Tinnitus will wear the Otoband set at a non-effective power level during a 30 minute time frame and outcome measurements will be recorded in a Google Form.
15758704|NCT04787614|Other|No intervention|No intervention
15758705|NCT04787601|Other|Exercise|Cognıtıve-based neuromuscular exercıses will be applied.
15758706|NCT04787601|Other|Classic Training|Classic match preparation training
15758707|NCT04787575|Procedure|Oxygen-ozone therapy|"Oxygen-ozone therapy (group a) will be performed by:
~i) Self-haemoinfusion of 200 cc. with concentrations of 40-50 μg/ml, to be performed two/three times a week, for a time of 6 weeks (for a maximum of 15 sessions); ii) Subcutaneous injections in the perilesional site at the dose of 5 cc. with concentrations of 4 μg,/ml, Cleanse wounds with 100 cc of 5-10 ug ozone gas"
15758708|NCT04787562|Drug|XNW4107, Imipenem/Cilastatin|"Drug: XNW4107 250mg IV over 60 minutes as a single dose
~Drug: Imipenem/Cilastatin 500mg/500mg IV over 60 minutes as a single dose"
15758709|NCT04787562|Drug|XNW4107, Imipenem/Cilastatin|"Drug: XNW4107 250mg IV over 60 minutes as a single dose
~Drug: Imipenem/Cilastatin 500mg/500mg IV over 60 minutes as a single dose"
15758710|NCT04787562|Drug|XNW4107, Imipenem/Cilastatin|"Drug: XNW4107 250mg IV over 60 minutes as a single dose
~Drug: Imipenem/Cilastatin 500mg/500mg IV over 60 minutes as a single dose"
15758711|NCT04787562|Drug|XNW4107, Imipenem/Cilastatin|"Drug: XNW4107 100mg IV over 60 minutes as a single dose
~Drug: Imipenem/Cilastatin 200mg/200mg IV over 60 minutes as a single dose"
15758712|NCT04787562|Drug|XNW4107, Imipenem/Cilastatin|"Drug: XNW4107 100mg IV over 60 minutes as a single dose
~Drug: Imipenem/Cilastatin 200mg/200mg IV over 60 minutes as a single dose"
15758713|NCT04787549|Device|Virtual reality exergames|A total of 10 sessions were held for 30 minutes, 2 to 3 times a week for exergames using fully immersive virtual reality under the assistance of an occupational therapist.
15758714|NCT04787536|Procedure|Non-cardiac surgery|Non-cardiac surgery excluding cranial neurosurgery
15758715|NCT04787523|Radiation|Radiotherapy|Patients have received neoadjuvant radiotherapy
15758716|NCT04787510|Drug|low molecular weight Heparin as standard of care treatment|STANDARD OF CARE
15758717|NCT04787497|Dietary Supplement|High Phenolic Extra Virgin Olive Oil|Participants will be randomly assigned in two groups: the Experimental Group (N= 50) will be receiving 50ml of freshly, cold-pressed, oleocanthal-rich EVOO alongside their prescribed medical treatment, whereas the Control Group (N = 50) will be receiving their medical treatment as usual. The Experimental Group will be receiving the complementary treatment on a daily basis for 12 months and all participants will undergo a neuropsychological assessment at baseline, 6 months and 12 months +/- 7 days after their first assessment or beginning of treatment.
15758718|NCT04787471|Combination Product|30 minute photoactivation of riboflavin 0.1%|Use of riboflavin 0.1% eye drops and 3mW/cm2 UVA light for 30 minutes
15758719|NCT04787471|Combination Product|10 minute photoactivation of riboflavin 0.1%|Use of riboflavin 0.1% eye drops and 9mW/cm2 UVA light for 10 minutes
15758720|NCT04787458|Device|abdomen binder (Sejung Korea, Seoul, Republic of Korea)|abdomen binder with a standard height of 22 cm (Sejung Korea, Seoul, Republic of Korea)
15758721|NCT04787432|Behavioral|Salutogenic Frailty Prevention Program|"Laughter yoga: The first component of intervention is the laughter yoga that is a combination of warm up exercise, deep breathing exercises, childlike playfulness and laughter exercises. Each session of laughter yoga will be offered twice a weekly and 40 minutes each time.
~Health education: The second component of intervention consisted of six health issues which are health, frailty and generalized sources of resistance for frailty, the most common medical condition and medication use, physical activity, healthy diet, falls prevention and cognitive and psychosocial well-being.
~Case management: The third component of intervention is activities that determine each participant's health needs with the Omaha System and support them for the use of appropriate resources."
15758722|NCT04787419|Other|placebo|saccharum lactis
15758723|NCT04787419|Combination Product|probiotics|Lactobacillus acidophilus, Bifidobacterium longum, Strepococcus thermophilus
15758776|NCT04786964|Drug|Dexamethasone 4mg|For prophylaxis; orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.
15759031|NCT04784832|Device|Peripheral Nerve Stimulation|Electric stimulation of the nerves
15758724|NCT04787406|Device|Transcranial direct current stimulation|"Transcranial electrical stimulation device. A weak direct electrical current, up to 2 mA, is passed between two electrodes placed on the scalp. Electrodes are housed in 35 cm2 sponges saturated with 4 ml of saline solution (0.9 % NaCl) per side, per pad.
~Stimulation is phased in with a 30 second ramp up period prior to the specified stimulation period and phased-out with a ramp down of the current following the specified stimulation period. For sham stimulation, the ramp-up and ramp-down periods are retained, but stimulation is switched off for during the specified stimulation period."
15758725|NCT04787393|Device|Heartfelt device|"The Heartfelt device uses a system of cameras in a compact device to generate 3D images of the feet and lower legs with a view to detecting early volume changes. The device can be installed on the wall or as a free standing unit; however, given the COVID-19 pandemic, only the free standing option will be available to participants, so as to avoid the necessity of an installer visiting the patient. For the measurements to take place, the participant walks in the field of view of the device. Participants are not expected to change anything to their routine. The device can also take measurements in the dark.
~The switch between 'full data analysis' and 'technical checks only' modes can be done remotely, making the cross-over seamless.
~In the event that an alert is generated by the device, a medical assessment will take place either by phone or face to face appointment to evaluate the participant's condition."
15758726|NCT04787393|Device|Connected weighing scales|"The participant will be instructed to use those scales for the period of the study, as often as directed by their healthcare professional. The weighing scales display weight so that the participants can record the weight in their own heart failure records if they wish to do so.
~The scales will communicate with the Personal Computer (PC) contained in the Heartfelt device and the data will be sent to the Heartfelt server through an encrypted link.
~The data from the scales will be reviewed retrospectively, as the comparison in this study is with standard care, not with enhanced provision of care, which would be the case if we were using automatic reporting of weights."
15758727|NCT04787380|Device|Heartfelt device|"The Heartfelt device uses a system of cameras in a compact device to generate 3D images of the feet and lower legs with a view to detecting early volume changes. The device can be installed on the wall or as a free standing unit; however, given the COVID-19 pandemic, only the free standing option will be available to participants, so as to avoid the necessity of an installer visiting the patient. For the measurements to take place, the participant walks in the field of view of the device. Participants are not expected to change anything to their routine. The device can also take measurements in the dark.
~The switch between 'full data analysis' and 'technical checks only' modes can be done remotely, making the cross-over seamless.
~In the event that an alert is generated by the device, a medical assessment will take place either by phone or face to face appointment to evaluate the participant's condition."
15758728|NCT04787367|Procedure|TAP block|"An 18-gauge needle will be introduced externally at the center of the mid axillary line between the lower costal margin and the iliac crest until the surgeon feels a pop, after which the surgeon will inject the first 2 mL of 0.25% bupivicaine to verify the correct position. Doyle's internal bulge sign (the bulge seen when the transversus abdominis muscle and peritoneum is pushed internally) will be visualized and the remainder of the 60 mL of 0.25% bupivacaine will be injected. The contralateral block will be performed according to the same technique but with only 30 ml of bupivicaine."
15758729|NCT04787354|Drug|Oxaliplatin|Oxaliplatin: 130 mg/m2/day
15758730|NCT04787354|Drug|Capecitabine|Capecitabine: 2,000 mg/m2/day
15758731|NCT04787341|Drug|Regorafenib|"regorafenib administered until progression, unacceptable toxicity or patient's refusal followed after progression by panitumumab until further progression, unacceptable toxicity or patient's refusal in RAS and BRAF wt mCRC patients with the following characteristics:
~previous treatment with, or not considered candidates for, fluoropyrimidine, oxaliplatin, irinotecan and anti-angiogenic agent (bevacizumab or aflibercept);
~RECIST response or stable disease lasting at least 6 months to a previous first-line anti-EGFR-based treatment;
~RAS and BRAF wt ct-DNA at the time of screening."
15758732|NCT04787341|Drug|Panitumumab|"panitumumab administered until progression, unacceptable toxicity or patient's refusal followed after progression by regorafenib until further progression, unacceptable toxicity or patient's refusal in RAS and BRAF wt mCRC patients with the following characteristics:
~previous treatment with, or not considered candidates for, fluoropyrimidine, oxaliplatin, irinotecan and anti-angiogenic agent (bevacizumab or aflibercept);
~RECIST response or stable disease lasting at least 6 months to a previous first-line anti-EGFR-based treatment;
~RAS and BRAF wt ct-DNA at the time of screening."
15758733|NCT04787328|Drug|HA121-28 tablets|HA121-28 600 mg, po, QD×21 days, every 4 weeks (28 days)
15758734|NCT04787315|Device|Conventional intensive functional rehabilitation + Workstations|Equipment will be provided to participants where they can do exercises to increase their motor abilities at the lower limbs, trunk and upper limbs, in addition to conventional intensive functional rehabilitation
15758735|NCT04787315|Behavioral|Conventional intensive functional rehabilitation|Includes rehabilitation interventions provided by professionnals (OT, PT, speech language therapy, neuropsychologists...)
15758739|NCT04787289|Drug|Bevacizumab|Low standard dose of bevacizumab, combined with single agent chemotherapy (7.5mg/kg IV Q3w or 5mg/kg IV Q2w)
15758740|NCT04787276|Dietary Supplement|E.coli Nissle 1917|Probiotic contains biomass of E.coli Nissle 1917, 2,5-25·109 colony forming units - CFU/g
15758741|NCT04787276|Drug|Lactulose|will receive 30-60 ml of lactulose in 2 or 3 divided doses so that patient passed 2-3 semisoft stools per day, 1 months of treatment
15758742|NCT04787276|Drug|Rifaximin|rifaximin, oral, 500 mg BID, 1 months of treatment
15758743|NCT04787263|Biological|CD19-CAR_Lenti T cell|Fresh peripheral blood mononuclear cells are manufactured to obtain CD19-CAR_Lenti T cell, second generation CAR T cells incorporating the 4-1BB costimulatory domain. The fresh product is infused following lymphodepletion chemotherapy at a dose of 1.0-3.0x10^6 CAR+ cells/kg.
15758744|NCT04787250|Biological|Phage Therapy|Phage will be administered based on patient's matching results.
15758745|NCT04787250|Procedure|Two-Stage Exchange Arthroplasty|Performed per the study center's standard of care. No investigational products are used.
15821829|NCT04269252|Other|CHI-804|CHI-804 is the placebo formulation.
15758746|NCT04787237|Other|VST and immediate implants|One-cm long vestibular access incision was made using a 15c blade 3-4 mm apical to the mucogingival junction at the related socket . A subperiosteal tunnel was created connecting the socket orifice and the vestibular access incision using periotomes and micro periosteal elevators (. Implant fixture were then inserted after drilling to its pre-planned location 3-4 mm apical to socket base with adequate primary stability achieved using a torque wrench reaching 30 Ncm torque . A flexible cortical membrane shield that is made of cortical bone of heterologous origin of 0.6 mm thickness was hydrated and then trimmed and introduced from the vestibular access incision reaching 1 mm below the socket orifice through the tunnel . The socket gap between the implant and the shield was then packed thoroughly with particulate bone graft
15758747|NCT04787237|Other|Buser technique and early implants placement|In Buser's group early implant placement, the failing tooth was extracted atraumatically using a periotome. A collagen plug was placed to stabilize the wound clot. A healing period of 8-12 weeks (depending on the size of the extracted tooth) was followed. Then an open flap implant surgery using a triangular flap design was cut. After preparing the implant bed, the site was irrigated using normal saline. A healing abutment was then attached. Contour augmentation was done using autogenous bone chips mixed with saline and bone conditioned medium (BCM) added to bioss bone granules to activate it. A non-cross liked membrane was then placed, after being soaked with BCM. Finally, the healing abutment was removed and the flap was released to allow for its suturing.
15758748|NCT04787224|Other|immediate implant with vestibular socket therapy|A 1-cm long vestibular access incision was cut, 3-4 mm apical to the mucogingival junction of the involved tooth. The socket orifice and the vestibular access incision were connected by a subperiosteal tunnel that was created using a periotome and a micro-periosteal elevator. Implants were installed using a CADLCAM surgical guide. A flexible cortical membrane shield of heterologous origin, 0.6 mm in thickness was prepared by hydrating and trimming it. It was then tucked through the vestibular access incision, till it extended 1 mm below the socket orifice, and stabilized using a membrane tack ( to the apical bone. The gap between the implant and the shield/the labial plate was then filled with particulate bone graft [75% autogenous bone chips harvested form local surgical sites and 25% inorganic bovine bone mineral matrix.
15758749|NCT04787211|Drug|BRII-196 and BRII-198|BRII-196 and BRII-198 given by intravenous administration
15758750|NCT04787211|Drug|Placebo|Placebo given by intravenous administration
15758751|NCT04787198|Drug|hypertonic saline|The site of injections will be determined by palpation of the contracted First Dorsal Interosseus (FDI) muscle. The skin will be cleaned with alcohol before injection. A bolus injection of hypertonic saline (7% NaCl) will be administered to the FDI muscle using a 1 mL syringe with a disposable needle (27G), and 30 the volume of the bolus will be 0.2 mL .
15758752|NCT04787198|Drug|isotonic saline|The site of injections will be determined by palpation of the contracted First Dorsal Interosseus (FDI) muscle. The skin will be cleaned with alcohol before injection. A bolus injection of 0.2 mL isotonic saline (9 mg/mL) will be administered to the FDI muscle as control.
15758753|NCT04787185|Radiation|Valutation of toxicity|"Observation of toxicity
~All patient with Brain metastases from NSCLC who are candidates for RS or HFSRT in course of immunotherapy"
15758754|NCT04787172|Radiation|Multi Slice computed tomography|use of MSCT as a diagnostic tool in evaluation of patients with congenital cardiovascular anomalies
15758755|NCT04787146|Other|No intervention|Once the patient is included, a drug assessment is carried out as part of the treatment and then an compliance questionnaire is submitted to him.
15758756|NCT04787120|Device|SQUIDperi|Liquid embolic delivery syringes and micro-catheter
15758757|NCT04787107|Device|Mechanical Chair Massage|Healthcare staff will be placed into either massage or break intervention
15758760|NCT04787081|Other|Sleep Care Positioning Training Program GRP1|Video-based tutorial covering six nighttime postural care topic areas which contained narration and closed captioning. This 2-hour online training program was delivered in a University classroom via D2L Brightspace.
15758761|NCT04787081|Other|Sleep Care Positioning Training Program GRP2|Web-link based tutorial covering six nighttime postural care topic areas which contained mostly written content. This self-paced online training program was delivered in a University classroom via D2L Brightspace.
15758762|NCT04787068|Behavioral|Occupational Therapy support|Intervention include (a) didactic education about diseases; (b) the use of errorless techniques to improve assistance for CR's Activities of Daily Living (ADL), Instrumental ADL, and communication tasks; (c) the use of incentives (e.g., providing a favorite scented shampoo); (e) use of a schedule/calendar on a computer, cell phone and/or blackboard in CR's home to coordinate caregiving tasks for family members; (f) suggesting more frequent PACE daycare visits or use of a nearby PACE, having a snack or short game to prevent going to bed right after dinner); (d) use of the Buffalo Functional Exercise for strengthening ( a home-based exercise developed for PACE by the PI and shown to be effective in preventing falls)
15758763|NCT04787055|Device|Receiver-in-canal hearing instrument|Receiver-in-canal hearing instrument
15758764|NCT04787042|Biological|ST-067|ST-067 is an engineered variant of human interleukin-18.
15758765|NCT04787029|Device|Medical compression stocking (medical device name: mediven Harmony 734 (compression class1 AG armsleeve or with wide(735))|Compression stockings worn on the arm or partial swelling of the hand after trauma or surgery.
15758766|NCT04787016|Other|Pilate training|Pilates is an exercise training program used to build core strength and flexibility.
15758767|NCT04787003|Drug|oncolytic virus (OVV-01) injection|intratumoral injection of OVV-01 with or without immune checkpoint inhibitors
15758768|NCT04786990|Drug|SPN-812|Viloxazine extended-release capsule
15758769|NCT04786977|Other|No Intervention, Observational Study|No Intervention
15758770|NCT04786964|Drug|Cosibelimab|IV infusion
15758771|NCT04786964|Drug|Cisplatin|IV infusion
15758772|NCT04786964|Drug|Carboplatin|IV infusion
15758773|NCT04786964|Drug|Pemetrexed|IV infusion
15758774|NCT04786964|Dietary Supplement|Folic acid 350-1000 μg|Orally; at least 5 doses of folic acid must be taken during the 7 days preceding the first dose of pemetrexed, and folic acid dosing must continue during the full course of therapy and for 21 days after the last dose of pemetrexed.
15758780|NCT04786938|Drug|Saccharomyces Boulardii-Containing Product in Oral Dose Form|S. boulardii CNCM I-745 (approximately 22.5 x109 CFU)
15758781|NCT04786925|Other|Control diet|Control diet: A Mediterranean conventional diet based on the current dietary guidelines of the Spanish Society of Community Nutrition (SENC). Participants were strongly advised to use the Healthy Eating Plate (Harvard) to structure and prepare the main meals (lunch and dinner). In this way, at least ½ of the plate should be composed of vegetables, ¼ of lean protein, and ¼ of low glycemic index carbohydrates. The diet encourages participants to eat 5 times/day (breakfast, lunch, dinner, and two snacks). Overall, the control diet was based on high consumption of vegetables and fruits, whole grains, healthy fats (olive oil), and healthy proteins (legumes, fish, and lean meat). There was not energy restriction in the control diet.
15758782|NCT04786925|Other|Nutriprecision diet|Nutriprecision diet: a Mediterranean balanced diet based on the inclusion of precision foods designed according to the particularities of the senior population. The selected precision foods were a) fruit compote, b) smoothie, c) extruded meat product, d) wholemeal bread, e) wholemeal biscuit and f) microwaveable deep-frozen vegetable products. The diet encourages participants to eat 5 times/day with a conventionally balanced distribution of macronutrients (50% of the total caloric value from carbohydrates, 20% from proteins, and 30% from lipids). There was not energy restriction, although the energy requirements of the participants were adjusted to a BMI of 25 kg/m2 to avoid an overestimate of calorie intake. A mobile application designed and developed to provide volunteers with information about follow-up visits, the assigned diet, recommendations, and messages to motivate them during the intervention. A digital tool for cognitive stimulation.
15758783|NCT04786886|Other|VIrtual Reality Visual Field Exam|Virtual reality visual field exam will be administered using the virtual reality headset. Exams can take up to 20 minutes.
15758784|NCT04786873|Drug|Macimorelin|Dosage form: granules for oral solution, Dosage: 1.0 mg/kg body weight, Frequency and duration: single oral dose administration. Macimorelin will be supplied in single-use aluminum pouches (synonymous: sachets) each containing 63.6 mg macimorelin as acetate, which provide 0.5 mg/mL of macimorelin when dissolved in 120 mL of water. The excess amount of 3.6 mg represents an overfill, which is needed to obtain the target concentration.
15758785|NCT04786873|Diagnostic Test|Arginine|For the arginine GHST, R-Gene® 10 from Pfizer will be provided as labelled investigational medicinal product (IMP). After an overnight fast, soluble arginine hydrochloride (0.5 g/kg) will be given i.v. as an infusion with an infusion duration of 30 min.
15758786|NCT04786873|Diagnostic Test|Clonidine|"For the clonidine GHST, CATAPRESAN® 75 tablets (Boehringer Ingelheim) will be provided as labelled IMP. Each tablet contains 75 ug clonidine hydrochloride. The tablets will be provided in boxes containing 10 tablets. The target dose is 0.15 mg/m2 body surface with a dose range of 0.08 - 0.15 mg/m2. Maximum dose will be 0.25 mg.
~After an overnight fast, clonidine (0.15 mg/m2 body surface) will be given orally."
15758787|NCT04786860|Procedure|CPR|Cardiopulmonary resuscitation performed on patients with in-hospital cardiac arrest
15758789|NCT04786834|Procedure|Vesico urethral anastomosis on chicken model|Performance of a vesico urethral anastomosis on a chicken model with Da Vinci robotic system
15758790|NCT04786821|Behavioral|Standard Exercise Training|Participants will receive interventions by an exercise specialist for up to 30 minutes based on the participant's tolerance. The exercises used in control group will depend on the individual and their abilities as evaluated in the baseline assessment session. Possible exercises include arm crank, recumbent cycle, and chair exercises. These sessions will be delivered by a member of the research team.
15758791|NCT04786821|Device|Phoenix Exoskeleton suit|Participants will aim to walk wearing the Exoskeleton for up to 30 minutes. Based on the participant's tolerance, the duration of walking can be shorter and can be split into shorter intervals to achieve more activity. Over the sessions, based on the participants' tolerance, gradually the duration of walking can be increased with shorter breaks. This will be delivered by a research physiotherapist.
15758792|NCT04786795|Drug|Compound Azintamide Enteric-coated Tablets|the experimental group takes Compound Azintamide Enteric-coated Tablets.They were registered before medication and on days 14 and 28 after medication, and gastrointestinal symptoms were assessed at each follow-up visit
15758793|NCT04786795|Drug|Oryz-aspergillus Enzyme both Pancreatin Tablet and Ursodeoxycholic Acid Tablets|the control group takes Oryz-aspergillus Enzyme both Pancreatin Tablet and Ursodeoxycholic Acid Tablets. They were registered before medication and on days 14 and 28 after medication, and gastrointestinal symptoms were assessed at each follow-up visit
15758794|NCT04786782|Diagnostic Test|PPG-detecting software|Virtual PPG (vPPG) of patients in experimental group is calculated based on anatomical and hemodynamic information of portal system collected by ultrasound and CT tests.
15758795|NCT04786782|Diagnostic Test|LSM and PLT count|Patients whose LSM >15kPa, or PLT count < 150*10^9 should be screened with upper GI endoscopy
15758796|NCT04786769|Drug|Ferric carboxymaltose|Intravenous ferric carboxymaltose according to baseline weight and hemoglobin
15758797|NCT04786756|Drug|Bupivacaine 0.25% Injectable Solution|1 mg/kg Bupivacaine (0.25%)
15758798|NCT04786743|Other|endoscopic intervention|performing endoscopy
15758799|NCT04786730|Drug|Centanafadine|Doses of centanafadine will be taken once daily in the morning on Days 1 through 14. The fixed dose strengths will be administered according to body weight. Up to 12 subjects will be enrolled in the 9 to 12 years age cohort (Cohort 1), up to 8 subjects will be enrolled in each of the 6 to 8 years age cohorts (Cohorts 2 and 3), and up to 5 subjects will be enrolled in each of the 4 to 5 years age cohorts (Cohorts 4 and 5).
15758800|NCT04786717|Other|core muscle training|The intervention of this group will focus on training the endurance of the core muscle.
15758801|NCT04786717|Other|movement control training|Based from the initial test, the subjects will receive either lumbar flexion control exercise or lumbar extension control exercise. They will perform each lumbar movement control exercise in different position. Starting from the lying position, then progressing to sitting, standing with support, and the last level will be standing without support. Each set of movement will be practiced 10 times, totally 10 sets. It will take approximately 5~8 minutes to finish each movement. The subjects will learn 5~8 types of the movement every week.
15758826|NCT04786535|Procedure|Hemodiafiltration|"Single-use high-flux hemodialyzer
~Post-dilution mode
~Minimum convective volume of 23 L
~Blood flow (Qb) minimum of 300 mL/min
~Dialysis flow (Qd) 700 mL/min
~Minimum therapy time of 4 hours
~Ultrafiltration necessary to achieve dry weight"
15759032|NCT04784832|Device|Transcranial direct current stimulation|Electric stimulation of the cortex
15758802|NCT04786717|Other|combined imagery and movement control training|The intervention of this group is mostly same as the movement control training group. The different part is that the first 3 times of the movement will be practiced through image training, so the subjects will not have any real movement, and the last 7 times they will perform the lumbar motor control exercise literally. Each set of movement will be practiced 10 times, totally 10 sets. It will take approximately 5~8 minutes to finish each movement. The subjects will learn 5~8 types of the movement every week.
15758803|NCT04786704|Diagnostic Test|Stool-based SDC2 DNA methylation test|A diagnostic device measuring syndecan 2(SDC2) methylation status in stool DNA to detect colorectal cancer
15758804|NCT04786704|Diagnostic Test|quantitative Fecal immunochemical test|A diagnostic device using immunoturbidimetric methods to measure fecal hemoglobin concentration
15758805|NCT04786691|Other|Addition of half and half to coffee|1 oz of half and half is added to 12 oz of black coffee and given to participants assigned to this arm after the baseline gastric ultrasound
15758806|NCT04786691|Other|Addition of non-dairy creamer to coffee|1 oz of non-dairy creamer is added to 12 oz of black coffee and given to participants assigned to this arm after the baseline gastric ultrasound
15758807|NCT04786691|Other|Black|No Creamer
15758808|NCT04786678|Behavioral|Cell phone notification|Habitual bed and wake times will be detected using a wearable for 4 weeks. Using habitual wake time, a minimum bedtime to achieve adequate sleep will be calculated (8 hours). If phone usage is detected after this minimum bedtime, participants will receive a notification informing them they are awake past their minimum bedtime and recommend they go to bed to obtain adequate sleep.
15758809|NCT04786665|Other|Strawberry|Freeze dried strawberry powder
15758810|NCT04786665|Other|Placebo group|Comparative placebo powder
15758811|NCT04786652|Device|estimated stroke volume variation (esSVV, Nihon Kohden, Japan)|Assessment of the estimated stroke volume variation (esSVV, Nihon Kohden, Japan) in the early postoperative period after OPCAB
15758812|NCT04786652|Diagnostic Test|Assessment of fluid responsiveness in mechanically ventilated patients after OPCAB|In mechanically ventilated patients after OPCAB within two hrs after intervention: passive leg raising (PLR), increased PEEP, and mini-fluid load (mFL) tests will be followed by standard fluid load (sFL). Monitoring: SVVPCA, PPVPCA, esSVV, HLI, PVI, pre-ejection fraction (PEP, echocardiography), CIPCA, esCI and CISTD. Transthoracic echocardiography will be performed to assess the volume of heart chambers, ejection fraction and pre-ejection phase (PEP).
15758813|NCT04786652|Diagnostic Test|Assessment of fluid responsiveness in spontaneously breathing patients at 18 hrs of the postoperative period|2) In spontaneously breathing patients at 18 hrs of the postoperative period: PLR, and mFL tests followed by sFL. Monitoring: SVVPCA, PPVPCA, esSVV, PVI, PEP, CIPCA, esCI and CISTD. Transthoracic echocardiography will be performed to assess the volume of heart chambers, ejection fraction and pre-ejection phase.
15758814|NCT04786626|Diagnostic Test|Ultrasound evaluation|After vaginal, all patients were followed by traditional 2D US scanning and Doppler velocimetry on Days: 0, 2, 30, 60 and 90. Authors evaluated: scar diameter and Doppler velocimetry and resistance index (RI) of the uterine arteries, at their ascending branch
15758815|NCT04786613|Other|Intra-articular 20 mg, 1.0% Hyaluronic Acid Injection|"Intra-articular 2 ml linearly linked 20 mg 1.0% hyaluronic acid injection in 5 sessions will be applied.
~As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions."
15758816|NCT04786613|Other|Intra-articular 32 mg, 1.6% Hyaluronic Acid Injection|"Intra-articular 2 ml linearly linked 32 mg 1.6% hyaluronic acid injection in 3 sessions will be applied.
~As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions."
15758817|NCT04786613|Other|Intra-articular 48 mg, 2.0% Hyaluronic Acid Injection|"Intra-articular 2,4 ml linearly linked 48 mg 2.0% hyaluronic acid injection in single session will be applied.
~As a home exercise program, hamstring and quadriceps stretching, quadriceps isometric strengthening, short arc terminal extension exercises will be given at least three days a week with 3 sets of 10 repetitions."
15758820|NCT04786587|Diagnostic Test|blood test|"Each pregnant woman completes the self-report during her prenatal consultation and will have a unique blood sampling for dosage of phosphatidylethanol after she returned her self-report to the practitioner and if she is included in the study (informed consent given).
~the blood test for dosage of phosphatidylethanol will be offered to all eligible pregnant women in each maternity clinic of the study during the recruitment period. There will not be different arms in this study."
15758821|NCT04786587|Other|self-administered questionnaire|"Each pregnant woman completes the self-report during her prenatal consultation and will have a unique blood sampling for dosage of phosphatidylethanol after she returned her self-report to the practitioner and if she is included in the study (informed consent given).
~A self-report, including the T-ACE, is the usual prenatal consultation procedure in the three maternities of the study. The specific procedure for the study is to perform a blood test for dosage of phosphatidylethanol in eligible pregnant women after informed consent."
15758822|NCT04786574|Drug|Tolvaptan (OPC-41061)|Tolvaptan suspension will be administered orally or via nasogastric tube at doses of 0.15 mg/kg once daily in the AM, 0.30 mg/kg once daily in the AM, 0.5 mg/kg once daily in the AM, 0.75 mg/kg split dose (0.5 mg/kg AM and 0.25 mg/kg 8 hours later), and 1 mg/kg split dose (0.67 mg/kg AM and 0.33 mg/kg 8 hours later) based on age. Treatment duration is 2 years.
15758823|NCT04786548|Drug|Celecoxib|Patients will receive standardized pharmacotherapy with celecoxib 100mg twice daily for the first week, and will then, if well-tolerated, will be increased to 200mg twice daily for the next seven weeks.
15758824|NCT04786535|Procedure|Expanded Hemodialysis|"Single-use Theranova 400 Dialyzer
~Blood flow (Qb) minimum of 300 mL/min
~Dialysis flow (Qd) 500 mL/min
~Minimum therapy time of 4 hours
~Ultrafiltration necessary to achieve dry weight"
15758825|NCT04786535|Procedure|High-flux Conventional Hemodialysis|"Single-use high-flux hemodialyzer
~Blood flow (Qb) minimum of 300 mL/min
~Dialysis flow (Qd) 500 mL/min
~Minimum therapy time of 4 hours
~Ultrafiltration necessary to achieve dry weight"
15821884|NCT04268784|Drug|Placebo|Single and repeating oral dose(s)
15758827|NCT04786522|Diagnostic Test|Bioimpedenziometry, Handgrip strenght evaluation|The measurement of body composition was performed using Bioimpedance (BIA 101, Akern srl, Pontassieve (FI), Italy). The handgrip dynamometer (Jamar, Sammons Preston, Bolingbrook, IL, USA) was used to determine the isometric force of the forearm.
15758828|NCT04786522|Diagnostic Test|Evaluation on blood specimens|Serum samples were assayed for calcium, phosphorus, magnesium, iron, lactate dehydrogenase (Ldh), creatine phosphokinase (Cpk), creatine kinase myocardial band (Ckmmb), myoglobin, thyroid stimulating hormone (TSH), 25(OH)-Vitamin D, osteocalcin, bone alkaline phosphatase (b-ALP), C-terminal telopeptide of type I collagen (CTX-I), haptoglobin, sclerostin, myostatin, and Irisin. Irisin serum concentrations were detected using a competitive ELISA kit (AdipoGen, Liestal, Switzerland)
15758829|NCT04786509|Diagnostic Test|Field tests|In this study we used three different standardized running tests, one sub-maximal test - Cooper 2400 m (C), and two maximal (all-out) tests - 100 m sprint (S) and shuttle run (SR).
15758830|NCT04786496|Behavioral|ITP+SA Wise intervention|Intervention designed to promote well-being and resilience in late adolescents and young adults. It includes two components: a self-affirmation (SA) activity and an ITP intervention. The SA component includes a list of values so that they could choose the three most important for them. Next, they are asked to write why those selected values are the most important to them. The ITP component resembled the intervention developed by David S. Yeager and colleagues and it was adapted to first year university students. It consisted of three parts. First, participants are asked to read scientific studies that provide evidence that behaviors are controlled pathways in the brain that have the potential to be changed under the right circumstances. Second, participants read several testimonials purportedly written by second year university students to bring credibility to the ITP. Finally, participants are asked to write their own version of such a narrative (self-persuasive writing exercise).
15758831|NCT04786496|Behavioral|ITP Wise intervention|Intervention designed to promote well-being and resilience in late adolescents and young adults based on four general types of change strategies: (1) scientific knowledge, (2) generation of new meanings, (3) commitment through action, and (4) active reflection. It includes the ITP component described above for the ITP+SA Wise intervention.
15758832|NCT04786496|Behavioral|Control condition|The control intervention was designed to have a similar structure than the experimental interventions, including also reading and writing tasks, but that they were not in any way related to the contents of the experimental interventions. In particular, participants were asked to read an article about the fire that took place in the Notre Dame cathedral in Paris that had been recently published in a newspaper. Starting from the accident of the Notre Dame cathedral, the article focuses on reflecting on the problem of heritage conservation and analyzing the situation of other important cathedrals. After reading the article, the participants were asked to write a few lines evaluating in their opinion the importance of the conservation of historical buildings such as those mentioned and how much of the public economic budget should be used for heritage conservation.
15758833|NCT04786483|Other|Laughter Theraphy|"Laughter therapy will be applied for 60 minutes, 10 sessions, 2 days a week. The therapy, which starts with the stimulation of the acupuncture points in the palm and acquaintance with hand clapping for an average of 10 minutes, continues with deep breathing and breathing exercises that include diaphragmatic breathing. The childish games section, which is played to reveal and trigger simulated laughter, is the section where laughter starts as if and turns into reality. The last part is the part where the group makes eye contact for no reason and for no reason, and laughs for at least 3 minutes unconditionally. In the last part, wish meditation and relaxation sessions are performed."
15758834|NCT04786470|Drug|Ropivacaine|Ropivacaine infusion via transversus abdominis plane catheter.
15758835|NCT04786470|Drug|Saline|Saline infusion via transversus abdominis plane catheter.
15758837|NCT04786444|Biological|Biological Vaccine VLA1553|Single intramuscular vaccination on Day 1 with one of three Lots of VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate
15758838|NCT04786431|Other|Blood collection for lipid profiling by LC-MS|Blood withdrawal
15758839|NCT04786418|Other|Standard of care|Participants allocated to the control group will be given standard clinical information regarding healthy eating, physical activity and management of weight, in line with current NHS practise.
15758840|NCT04786418|Dietary Supplement|Low-calorie diet|The LCD intervention group, will received a well validated, commercially available, intensive weight management protocol Counterweight-Plus.
15758841|NCT04786405|Behavioral|Mindfulness meditation|Participants in the mindfulness meditation condition will practice a breath and body focused meditation.
15758842|NCT04786405|Behavioral|Clinical hypnosis|Participants in clinical hypnosis will be guided in a hypnosis practice with suggestions tailored towards shifting pain appraisals.
15758843|NCT04786392|Dietary Supplement|Lutein supplement|5 mg lutein supplement.
15758844|NCT04786392|Other|Food, blended|5 mg lutein from baby spinach, blended.
15758845|NCT04786392|Other|Food, unprocessed|5 mg lutein from baby spinach, in whole food form.
15758846|NCT04786379|Procedure|Arthroscopic Irrigation and Debridement|Patients with confirmed septic arthritis treated with multiple small incisions to perform irrigation and debridement with partial synovectomy.
15758847|NCT04786379|Procedure|Open Arthrotomy with irrigation and debridement|Patients with confirmed septic arthritis treated with a single large incision, open arthrotomy to perform irrigation and debridement with partial synovectomy.
15758848|NCT04786366|Other|The study does not have an intervention, but observe the AF incidence of the UK disease-free population|The study does not have an intervention, but observe the AF incidence of the UK disease-free population.
15758849|NCT04786353|Other|LongCOVIDkidsDK|Exposure: To be identified as an exposure for the current study, children from 0-18 years with at least one positive COVID test will be identified from Covid-19 data from January 2020 until the last updated version. To be able to identify the parents who will receive the questionnaires we will also need CPR-data on the children's parents.
15758850|NCT04786340|Drug|Active: WST-057 4mL (146 mg pirenzepine free base monohydrate) topical solution|WST-057 is pirenzepine a free base monohydrate. It is formulated into a topical solution (also the placebo); the solution is clear and viscosity is low enough for dispensing through a pump; each pump dispenses approximately 1 mL; patients are to use 4 mL every day approximately the same time of day;
15758851|NCT04786327|Procedure|Minimal invasive flap technique|contained defect treated with Minimally invasive flap
15758852|NCT04786327|Procedure|Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin|contained defect treated by Minimally invasive flap with root conditioning (EDTA) and platelet rich fibrin graft
15758853|NCT04786327|Combination Product|minimally invasive flap with root contioning by EDTA and growth factor enhanced matrix GEM21S|contained defect treated with Minimally invasive flap with root conditioning (EDTA) and growth factor enhanced matrix application in the defect
15758854|NCT04786314|Other|Hot Water Application|Pregnant women will apply hot water to their legs before going to sleep for a week.
15758855|NCT04786314|Other|Cold Water Application|Pregnant women will apply cold water to their legs before going to sleep for a week.
15758856|NCT04786288|Other|massage with lavender essential oil mixed in a carrier oil|22 elderly participants received a one session M technique hand massage that lasted 10 minutes for both their hands and arms using 2% lavender essential oil diluted with odourless baby oil (12 drops of lavender essential oil mixed in 30 ml of carrier oil) was used to apply the M technique hand massage
15758857|NCT04786288|Other|massage with odourless baby oil|odourless baby oil was used for the application of one session M technique hand massage on both hands and arms for 10 minutes for the 22 elderly participants.
15758858|NCT04786275|Drug|Fentanyl|Standard dose of 2 ug/kg after tetanic stimulation.
15758859|NCT04786275|Other|Tetanic stimulation|Standard tetanic stimulation will be used as the stimulus to evaluate response of the intraoperative pain index (NoL) at a standard fentanyl dose.
15758860|NCT04786262|Biological|VX-880|Infused into the hepatic portal vein.
15758861|NCT04786236|Device|"Physiological Control Module for the Medtronic -HVAD Left Ventricular Assist Device"|Software, which sets the device speed according to physiological demand, is activated for the duration of the tests (up to 4 hours). Every patient provides his/her own control, because sequences with active control and with standard pump operation are subsequently performed in randomized order (determined by permutated blocks).
15758862|NCT04786223|Drug|C-11 ER-176|Participants will receive a one-time administration of C-11 ER176 and undergo a PET/CT imaging study. Blood samples for plasma biomarker testing will be obtained as part of the study.
15758863|NCT04786223|Diagnostic Test|Blood Test|Participants will undergo a one time venipuncture blood collection to evaluate the presence of inflammatory and genetic markers.
15758864|NCT04786210|Combination Product|Fractional erbium:YAG-assisted drug delivery of 5-fluorouracil|Split-scar fractional ablative erbium laser-assisted delivery of 50mg/mL of 5-fluorouracil solution to one half of the scar (4 treatments)
15758865|NCT04786210|Combination Product|Fractional erbium:YAG-assisted drug delivery of triamcinolone acetonide|Split-scar fractional ablative erbium laser-assisted delivery of 10 mg/mL of triamcinolone acetonide solution to the other half of the scar (4 treatments)
15758866|NCT04786184|Behavioral|CALM Breathing|CALM Breathing is a mind-body breathing therapy that links CO2 changes to dyspnea and anxiety symptoms and targets breathing efficiency and self-efficacy in COPD. CALM Breathing: Individual interoception- based breathing therapy with capnography (non- exercise training) Home Program: Monitored home- based breathing exercises; RR biofeedback; goal setting; exercise logging. Coaching: Motivational interviewing. Personnel: PT, EP, occupational therapist, or nurse. Frequency: 1-hour sessions, twice per week for 4 weeks. Exercises: • 10 core breathing exercises with ETCO2 biofeedback in recovery postures at rest and with body movement (gentle stretches and brief low-moderate intensity physical activity). • Breathing biofeedback (ETCO2, RR, airflow pattern). Education: Education on anxiety; COPD Patient Guide.
15758867|NCT04786184|Behavioral|Traditional outpatient PR|"After referral to Rusk Rehabilitation's outpatient pulmonary rehabilitation (PR) program, participants randomized to the Wait-List control group will be put on a PR wait list (usual care). In Phase II, all participants will receive PR of 1-hour sessions, twice per week for 10 weeks. Traditional outpatient PR: Group exercise training (ET) combined with pursed lips breathing (PLB) training; 1:2 therapist to patient ratio. Home Program: Unmonitored walking exercise 1-2 days/week; no biofeedback monitoring. Coaching: Traditional monitoring and verbal cueing. Personnel: PT or EP. Frequency:
~1-hour sessions, twice per week for 10 weeks. Exercises: • ET of muscles of ambulation with exercise equipment, such as on a treadmill or cycle ergometer (30-min), plus 15-min strengthening and posture exercises; O2 supplementation as needed. No breathing biofeedback. • PLB instruction only during exercise training. Education: Verbal and written information."
15758868|NCT04786171|Diagnostic Test|4D X-ray Velocimetry|X-ray velocimetry uses fluoroscopy to quantify local ventilation in the lung.
15758869|NCT04786158|Drug|Apomorphine|Reporting the effects of subcutaneous apomorphine on pain and on quality of life
15758870|NCT04786145|Procedure|Cryoneurolysis|This is a medical procedure that temporarily blocks nerve conduction along peripheral nerve pathways by freezing it. Small probe is inserted in order to freeze the target nerve, can facilitate complete regeneration of the structure and function of the affected nerve.
15758871|NCT04786145|Procedure|Radiofrequency ablation|This is a medical procedure that temporarily blocks nerve conduction along peripheral nerve pathways. Small needle with an active heating tip is inserted, to destroy the functionality of the target nerve using heat from radiofrequency energy.
15758872|NCT04786145|Procedure|Placebo|No active treatment is given.
15758873|NCT04786132|Other|Cognitive-motor training|"A DT training protocol of 8 weeks duration was carried out, during 2 days a week, with a duration of 30 minutes each session divided into: warm-up (mobility and warm-up 5 '), main part (20') and cool down (5 'dynamic stretching). The main part consisted of a choreography divided into five measures of thirty-two beats each, in turn divided into four parts of eight movements, which included proprioception and balance exercises such as: squats, imbalances, lateral movements, front, standing on one leg, twist, etc. The sessions evolved from individual exercises, in pairs, in trios and finally in groups. The sessions included music that was unknown to the subjects but at the same time easy to learn, so that while they performed the motor tasks, they would memorize the songs.
~The sessions were carried out by the main researcher who controlled both the technique of the exercises and motivated them to sing and perform a cognitive exercise."
15758990|NCT04785157|Biological|serology testing profiles description|SARS-CoV-2 quasispecies detection and associated serology testing profiles description (peripheral blood and cerebrospinal fluid - CSF)
15758874|NCT04786132|Other|Motor training|A training protocol of 8 weeks duration was carried out, during 2 days a week, with a duration of 30 minutes each session divided into: warm-up (mobility and warm-up 5 '), main part (20') and cool down (5 'dynamic stretching). The main part consisted of a choreography divided into five measures of thirty-two beats each, in turn divided into four parts of eight movements, which included proprioception and balance exercises such as: squats, imbalances, lateral movements, front, standing on one leg, twist, etc. The sessions evolved from individual exercises, in pairs, in trios and finally in groups.
15758875|NCT04786119|Device|CORI Robotics|Knee arthroplasty with robotics assisted surgery using the CORI Robotics System.
15758876|NCT04786106|Drug|Collagenase Clostridium Histolyticum 0.9 MG [Xiaflex] (CCH)|Men in this cohort would receive the full series of 8 Xiaflex injections: 2 injections separated by 1-3 days, repeated 3 additional times with 6 week breaks between treatments.
15758877|NCT04786106|Procedure|Penile Plication Surgery|Men in this cohort would undergo surgery using either penile plication or incision and grafting. The specific surgery would be selected based on commonly used criteria: plication for curvatures <70 degrees; I&G used for ≥70 degrees or severe hourglass / hinge deformities. However, the specific surgery (plication vs I&G) will ultimately be decided based on the primary investigator's clinical judgment.
15758878|NCT04786106|Procedure|Incision and Grafting (I&G) Surgery|Men in this cohort would undergo surgery using either penile plication or incision and grafting. The specific surgery would be selected based on commonly used criteria: plication for curvatures <70 degrees; I&G used for ≥70 degrees or severe hourglass / hinge deformities. However, the specific surgery (plication vs I&G) will ultimately be decided based on the primary investigator's clinical judgment.
15758879|NCT04786106|Device|RestoreX Penile Traction Device|RestoreX is a Class I PTT device developed by PathRight Medical, is registered with the FDA, and has randomized controlled data demonstrating efficacy when used for the treatment of PD.
15758880|NCT04786093|Radiation|Stereotactic radiation therapy|Radiation therapy will be delivered using standard SAbR treatment schedule or every 4 weeks on the PULSAR schedule to achieve optimal local control of metastatic cancer and augment the effects of durvalumab.
15758881|NCT04786093|Drug|Durvalumab|Durvalumab (initially developed as MEDI4736) is a human monoclonal antibody of the immunoglobulin (Ig) G1 kappa subclass that inhibits binding of PD-L1 (B7-H1, CD274) to PD-1 (CD279) and CD80 (B7-1). MEDI4736 is composed of 2 identical heavy chains and 2 identical light chains, with an overall molecular weight of approximately 149 kDa. MEDI4736 contains a triple mutation in the constant domain of the Ig G1 heavy chain that reduces binding to complement protein C1q and the fragment crystallizable gamma receptors involved in triggering effector function.
15758882|NCT04786080|Behavioral|Parent Positive|"Parent Positive is a smartphone app delivering information and parenting support aiming to improve wellbeing within the family and reduce pressures on services given the ongoing pandemic-related challenges. It will consist of three zones, providing:
~structured advice, support and tips for parents
~facilitated parent-to-parent communication platform where parents can post questions of one another and parenting experts
~access to carefully selected high-quality, evidence-based online parenting resources."
15758883|NCT04786067|Drug|Belatacept|Patients will have tapering of their multi-drug immunosuppression, until Belatacept is the sole medication in their immunosuppression regimen. Belatacept will be administered as an infusion, as is routinely done clinically.
15758884|NCT04786054|Diagnostic Test|BED Questionnaire|BED Questionnaire
15758885|NCT04786041|Procedure|laparoscopic appendectomy|laparoscopic appendectomy
15758886|NCT04786028|Other|Isatuximab|Brand name for interventional drug is Sarclisa
15758887|NCT04786015|Other|Active Surveillance Reporting System|A system to actively record change in symptoms older adult patients experience following a chiropractic visit.
15758888|NCT04786002|Drug|Busulfan|The BU administration regimen was four times a day (Q6h), continuous intravenous infusion for 2 hours, 3 or 4 days in a row.
15758889|NCT04785989|Other|[U-13C]glucose|[U-13C]glucose will be administered as a bolus of 8 g (grams) over 10 minutes followed by 8 g/hour continuous infusion over 2 hours . This infusion rate will allow glucose tracer to reach sufficient enrichment without causing significant metabolic perturbation such as hyperglycemia.
15758890|NCT04785989|Other|[13C5]glutamine|6mg/kg of body weight of [13C5]glutamine will be administered as a bolus over 10 minutes (± 1 minute) followed by 6mg/kg/hr body weight continuous infusion for 2 hours through a peripheral IV catheter/line. This infusion rate will allow glutamine tracer to reach sufficient enrichment without causing significant metabolic perturbation such as hyperglycemia.
15758891|NCT04785976|Procedure|Surgical clipping and endovascular coiling|Surgical clipping: Apply aneurysm clip to clip the ruptured aneurysm. Endovascular coiling：Also called endovascular embolization, to block blood flow into an aneurysm.Preventing blood flow into an aneurysm helps to keep it from rupturing.
15758892|NCT04785963|Behavioral|Music with Suggestion|A nonpharmacological, short-term treatment that poses minimal risk and places very limited burden on patients seems ideal for this population, and music with suggestions is one such treatment option.
15758893|NCT04785963|Behavioral|Pain Information|The comparison condition of informational recordings about chronic pain are structured to account for non-specific effects of general time and attention and to evaluate whether the treatments of music alone, and music in combination with suggestion are effective in the reduction of pain intensity more than an appropriate control group.
15758894|NCT04785963|Behavioral|Music|The comparison condition of the music only is structured to account for the effect of music listening, and to evaluate whether the addition of suggestion optimizes its effectiveness in the reduction of pain intensity.
15758895|NCT04785950|Drug|Low-dose levonorgestrel intrauterine systems (LNG-IUS)|Any low-dose intrauterine system (IUS) marketed in Spain
15758896|NCT04785937|Diagnostic Test|Ultrasound and Magnetic Resonance|liver ultrasound (US), including shear wave elastography (SWE) with liver stiffness measurement and US- fatty liver indicator (US-FLI), and a multiparametric unenhanced liver magnetic resonance examination including MR spectroscopy (MRS), Proton Density Fat Fraction (PDFF) and T2* measurement with Multiecho technique, T1 mapping with Inversion Recovery method, and Intravoxel Incoherent Motion diffusion weighted imaging (IVIM-DWI), measuring different parameters.
15758897|NCT04785924|Drug|Imipenem+Relebactam|Antibiotic treatment for KPC producing CRE-containing gram-negative infections
15758898|NCT04785911|Drug|Antiemetic Combinations|Evaluation of response to treatment of hyperemisis gravidarum (antiemetics and other methods ) by PUQE score
15758899|NCT04785898|Diagnostic Test|ID Now™ COVID-19 Screening Test|"Patients, meeting the eligibility criteria, are selected consecutively in the emergency room. The investigating doctor delivers the written information note, answers the patient's questions and obtains his free, informed and express consent. The patient has sufficient time to reflect to make the decision to participate in the study. His oral, free, informed and express consent will be traced in the computerized medical file on the day of its inclusion in the COVID-IDNow protocol. Each patient participating in the study retains the possibility of participating simultaneously in another research. No exclusion period is provided for in the protocol."
15758900|NCT04785885|Diagnostic Test|iStat Handheld Blood Analyzer|An easy-to-use blood analyzer that provides monitoring of heparin anticoagulation quickly for point-of-care testing. Testing will be done at baseline, 30s, 90s and 180s after heparin administration.
15758901|NCT04785885|Diagnostic Test|Hemochron|An easy-to-use blood analyzer that provides monitoring of heparin anticoagulation quickly for point-of-care testing. Testing will be done at baseline, 30s, 90s and 180s after heparin administration.
15758902|NCT04785872|Other|Education|NEUMAN SYSTEMS MODEL BASED NURSING APPROACH
15758903|NCT04785859|Diagnostic Test|BPD prediction|"The following lung ultrasounds will be performed on the patients included in the study: first 24 hours of life, 3rd day of life (DOL) and 7th DOL. At one week of life detection of proteins in nasopharyngeal aspirates will be performed. During the first week of life, an echocardiography will be performed in all patients to evaluate the possibility of a patent ductus arteriosus and its hemodynamic significance.
~In the first 20 patients who remain intubated at one week of life, tracheal aspirates will be obtained too, to compare protein determination in both aspirates at the same time."
15758904|NCT04785846|Device|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
15758905|NCT04785833|Drug|T cell injection targeting CD7 chimeric antigen receptor|Drug name: T cell injection targeting CD7 autologous chimeric antigen receptor. Package specification: 10-50ml bag, 1-4 bags / person, which is determined according to the body weight of the subject and the effective content of cell preparation
15758906|NCT04785820|Drug|RO7121661|2100 milligrams (mg) administered by intravenous (IV) infusion once every 2 weeks on Day 1 of each 14-day cycle.
15758907|NCT04785820|Drug|RO7247669|2100 mg administered by IV infusion once every 2 weeks on Day 1 of each 14-day cycle.
15758908|NCT04785820|Drug|Nivolumab|240 mg administered by IV infusion once every 2 weeks on Day 1 of each 14-day cycle.
15758909|NCT04785807|Other|Post traumatic, Anxiety and depression evaluation|Family member of person or trust of patient who had a limitation or discontinuation of treatments will be identified and asked to fulfilled a hospitalized anxiety and depression scale and the revised Impact Event scale 7 and 30 days after the limitation or discontinuation of treatments announcement
15758910|NCT04785794|Biological|Sing2016 M2SR H3N2 influenza vaccine|This group will receive a dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally on Day 1 followed by IIV at least 28 days later.
15758911|NCT04785794|Other|Placebo|This group will receive saline placebo administered intranasally on Day 1 followed by IIV at least 28 days later.
15758912|NCT04785781|Other|without masks|apply a bicycle ergometer test protocol to individuals without a mask
15758913|NCT04785781|Other|Surgical face mask (Vheal Med Co., Ltd., Istanbul, Turkey)|apply a bicycle ergometer test protocol to individuals with a surgical mask
15758914|NCT04785781|Other|FFP2\N95 protective face mask (Musk protective technology, Gaziantep, Turkey)|apply a bicycle ergometer test protocol to individuals with a FFP2\N95 mask
15758915|NCT04785768|Drug|Hydromorphone Hydrochloride Injection|Intravenous PCA with hydromorphone after successful titration of 24 hours.the PCA setting: 1) continuous dose (dose/hours) = the total dosage of hydromorphone in the previous 24 hours/24; 2) bolus dose = 10-20% of the total dosage of hydromorphone in the previous 24 hours; 3) lockout time = 10 minutes; 4）Evaluate every 24 hours and PCA parameters were adjusted according to the dose of the previous day.
15758916|NCT04785768|Drug|Hydromorphone Hydrochloride Injection|Intravenous PCA with hydromorphone after successful titration of 24 hours.the PCA setting: 1) continuous dose = 0; 2) bolus dose = 10-20% of the total dosage of hydromorphone in the previous 24 hours: 3) lockout time = 10 minutes; 4)Evaluate every 24 hours and PCA parameters were adjusted according to the dose of the previous day.
15758917|NCT04785768|Drug|Morphine Sulfate Sustained-release Tablets|"Swift to sustained-release morphine orally as background dose with immediate release morphine orally for breakthrough pain after successful titration of 24 hours.
~Administration of morphine orally 1) Sustained-release morphine orally (dose/12 hours) = the total equianalgesic of the previous 24 hours/2×75% for day 1; 2）the total equianalgesic of the previous 24 hours/2 for day 2 ; 3）Evaluate every 24 hours and the dose for the next day is adjusted according to the dose of the previous day；4) Immediate release morphine orally = 10-20% of the total equianalgesic of the previous 24 hours;"
15758918|NCT04785755|Drug|Oral standard diuretics therapy|Oral standard diuretics therapy (furosemide 40 mg tablet plus spironolactone 100 mg tablet with a dose increase in 40 mg:100 mg ratio) given once daily in the morning for 38 days (from the first day of the study to the end of the study).
15758919|NCT04785755|Drug|Hypertonic saline solution|Hypertonic saline solution (150ml, 1.4% - 4.6%) infused slowly over one hour peripherally once daily from the first day of the study for eight days.
15758920|NCT04785755|Drug|Etilefrine|Etilefrine 5 mg tablet given by mouth three times daily for 38 days (from the first day of the study to the end of the study).
15758921|NCT04785742|Drug|Almonertinib|Almonertinib
15758922|NCT04785729|Drug|Almonertinib combine with Pyrrolitinib|110mg,qd Almonertinib+（240mg/320mg/400mg）,qd Pyrrolitinib
15758923|NCT04785716|Drug|Niraparib|Niraparib provided through the patient access program
15758924|NCT04785690|Device|CureSight|Subjects assigned to the binocular treatment group will be prescribed the CureSight treatment to watch for 90 minutes per day, 5 days a week for 16 weeks for the total of 120 hours. Parents of subjects will be instructed that the 90 minutes of daily treatment should be completed in a single 90-minute session, but if this is not possible for whatever reason, the treatment may be divided into two shorter sessions totaling 90 minutes per day
15758991|NCT04785157|Biological|immune response characterization|systemic and central immune response characterization , associated to the assessment of CNS damage biomarkers (peripheral blood and CSF)
15758992|NCT04785157|Other|in vivo brain PET-TSPO acquisitions|in vivo brain PET-TSPO acquisitions (Positon Emission Tomography using a radioligand that targets the Translocator Protein, which is upregulated in activated microglia)
15758925|NCT04785690|Device|Patching|"Subjects assigned to the patching group will wear an adhesive patch over the dominant eye for 2 hours per day, 7 days per week for 16 weeks. Parents of subjects will be instructed that the 2 hours of daily patching should be completed in a single 2-hour session, but if this is not possible for whatever reason, the treatment may be divided into shorter sessions totaling 2 hours.
~Parents will be asked to complete a usage diary by manually recording the patch usage time on daily basis."
15758926|NCT04785677|Behavioral|Resiliency in Stressful Experiences (RISE) Program|The Resiliency in Stressful Experiences (RISE) Program is a multi-phased comprehensive trauma based reentry program designed based on the transitional nature of reentry. Participants will receive up to 4 sessions prior to release and up tp 15 session post release from prison. The RISE program is a trauma intervention paired with reentry services, including housing support and employment assistance.
15758927|NCT04785664|Other|Community-based pro-Active Monitoring Program|The Intervention provides phone monitoring addressed to all the clients and home visits tailored to the individual needs. Moreover, it activates other formal or informal care resources based on the needs of the patients reported in the Individualized Care Plan (ICP) which derives from the assessment of multidimensional frailty. The main peculiarity of the program is that the operators identify the main problem of the client and try to track down the best solution in agreement with the client. It can be a health or social intervention or a different kind. Interventions may include assistance to make clients' houses safer thereby reducing risk factors for falls or reviewing the therapeutic scheme to improve patient adherence to the treatment in collaboration with the GP.
15758928|NCT04785651|Drug|Tibial osteotomy with Tranexamic acid|"Patients who will be in the treatment arm after randomisation will receive 100ml saline with a dosage of 20 mg/kg tranexamic acid intravenously at induction. An additional administration of tranexamic acid (10 mg/kg in 100ml intravenous saline) will be given as a booster at the end of the surgical procedure.
~All the patients will undergo to the same tibial osteotomy procedure."
15758929|NCT04785651|Procedure|Tibial osteotomy without Tranexamic acid|Patients in this arm will undergo to the tibial osteotomy procedure as by clinical practice
15758930|NCT04785638|Combination Product|INL-001 (bupivacaine hydrochloride) implant|INL-001 (bupivacaine hydrochloride) implant
15758931|NCT04785625|Combination Product|Bupivacaine Hydrochloride|INL-001 (bupivacaine hydrochloride) implant
15758932|NCT04785625|Combination Product|Placebo collagen-matrix implant|Placebo collagen-matrix implant
15758933|NCT04785612|Biological|RSVPreF|A single dose of 120 mcg RSVpreF for intramuscular injection
15758934|NCT04785612|Other|Placebo|A single Placebo dose for intramuscular injection to match experimental vaccine
15758935|NCT04785599|Behavioral|Exercices|An exercise program. Seven days after lymph node removal, participants began this program at the physiotherapy department. They attended two weekly sessions of 60 minutes each. The sessions at the centre continued for 12 weeks. The program consisted of aerobic exercise, in combination with resistance and stretching exercises.
15758936|NCT04785599|Behavioral|Informative talk|An informative talk: Patients attended a one-hour long talk about lymphedema. The topics covered were a description of the condition, the risks, and preventive measures to include in their daily life. The recommended measures were those from the general consensus of the International Lymphedema Society, the Spanish Rehabilitation Society and The National Breast and Ovarian Cancer Center
15758937|NCT04785599|Device|Compression garment|"Wearing a flat knit compression garment (CG), class 1. Participants were recommended to wear this CG for an average of 8 hours during the daytime for the first 3 months after surgery, and to remove it at night.
~From the fourth month onwards, use of the garment was reduced to 2 hours a day, coinciding with exercises and physical activity."
15758938|NCT04785586|Behavioral|Healthy Weight Coaching|Lifestyle intervention based on Healthy Weight Coaching (HWC) is a 52 week long web-based weight loss program consisting of weekly modules, exercises, peer support, and one-on-one coaching. It encompasses themes such as diet, physical activity, coping with stress, sleep, and general health.
15758939|NCT04785586|Behavioral|Individual meetings|Individual sessions via video, offered to the participant at three (3) different time points during the 12 month intervention.
15758940|NCT04785586|Behavioral|Group meetings|Group sessions via video, offered to the participant at three (3) different time points during the 12 month intervention.
15758941|NCT04785573|Dietary Supplement|Mastiha oil|1 soft gel capsule of Mastiha oil every day for 3 months
15758942|NCT04785560|Device|Initial shunt setting post-operatively of the Certas Plus shunt valve.|The setting/resistance of the Certas Plus Shunt valve implanted is set according to randomisation and is not changed until the first post-operative MRI is performed 36-48 hours after surgery.
15758943|NCT04785547|Drug|Blinatumomab|15 mcg/m2/day for 28 days
15758944|NCT04785534|Other|Clinical Evaluation|Undergo clinical evaluation
15758945|NCT04785534|Other|Laboratory Biomarker Analysis|Correlative studies
15758946|NCT04785534|Procedure|Liver Ultrasonographic Elastography|Undergo fibroscan
15758947|NCT04785534|Other|Survey Administration|Complete survey
15758948|NCT04785521|Radiation|Stereotactic radiosurgery|Gamma Knife stereotactic radiosurgery (SRS-GK)
15758949|NCT04785521|Diagnostic Test|Blood samples|Serum Glu levels and Glu-regulation markers assessed prior to and following SRS-GK in BM or benign lesions or at baseline in non-BM patients.
15758950|NCT04785508|Device|neuromuscolar tape|neuromuscalar tape application in decompression technique (hand and arm)
15758951|NCT04785508|Behavioral|antigravity arm position|antigravity arm position
15758952|NCT04785495|Other|Quality-of-life assessment|Patients will be provided the Functional Living Index - Emesis (FLIE) quality of life survey to be completed at time zero (before the application of chemotherapy) and then after 6 day, after application of chemotherapy.
15758953|NCT04785469|Other|Low-load eccentric training|"Aerobic exercise training on a downhill walking treadmill with the following settings: 10% negative incline and constant speed corresponding to 75% of the average speed recorded during the initial 6-Minute walk test.
~Resistance training: 5 minutes of warm-up on the manual ergometer, then 3 sets for 10 repetitions of the leg extension (performed unilaterally in eccentric phase) with a load of 75% of 1 repetition maximum (concentric) for the first two weeks. The following two weeks, 3 sets for 10 repetitions will be performed on the leg press (performed unilaterally in the eccentric phase) with 75% load of 1 repetition maximum (concentric). In addition, patients will perform 3 upper extremity strengthening exercises (free weights or elastic bands), including 2 sets of 10 repetitions for each exercise."
15758954|NCT04785469|Other|Usual care|"Aerobic exercise training using the cycle ergometer at an intensity calculated as follows: 2 minutes with load equal to 20% of maximum load, then 25 minutes with initial load at 50% of maximum load calculated as 103.217 + (30.500xGender) + (-1.613xAge) + [0.002x6-Minute walk work (6MWW)]. [Sex: female = 0; male:1] [6MWW = 6-Minute walk distance x weight in kg].
~Resistance training: 5 minutes of warm-up on the manual ergometer, then 5 exercises for upper and lower limbs performed with free weights or elastic bands. For the first 2 weeks will be performed 2 sets X 20 repetitions with 1 minute break between sets and a load that allows to perform no more than 20 repetitions. For the following 2 weeks, 3 sets of 10 repetitions x 10 repetitions with 2 min break between sets and a load that allows for no more than 10 repetitions."
15758955|NCT04785456|Device|Active TBS|MagPro X100 device equipped with a Cool-B70 A/P coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark)
15758956|NCT04785456|Device|Sham TBS|MagPro X100 device equipped with a Cool-B70 A/P coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark)
15758957|NCT04785443|Drug|ICG|"During thyroidectomy surgery, the patient will received 3 injections of 5 mg as a bolus. The first one during the dissection of the first lobe, then during the dissection of the second lobe and finally at the end of the dissection.
~Patients will then be followed during 6 months."
15758958|NCT04785443|Procedure|Control group|"During thyroidectomy surgery, patients are treated according to traditional surgery with detection of parathyroids with the naked eyes.
~Patients will then be followed during 6 months."
15758959|NCT04785417|Other|touch screen tablet|traditional occupational therapy in addition to games on tablet
15758960|NCT04785404|Procedure|primary skin closure|skin will be stitched after stoma reversal to heal by primary intention
15758961|NCT04785391|Diagnostic Test|Urine collection for NEPHROCLEAR CCL14 Test|Urine will be collected and banked for future analysis with the NEPHROCLEAR CCL14 Test
15758962|NCT04785378|Device|Medical mask|Participants will carry out field tests one day wearing a medical mask and the other day without a mask.
15758963|NCT04785378|Other|Field tests|Participants will perform 6 MWT and ISWT tests to determine their exercise capacity, and a 30-second sit and stand test to determine lower extremity endurance.
15758964|NCT04785365|Other|Long-Term Follow-Up of Patients who Received ATL001|Patients who received ATL001 in a clinical trial will be evaluated in this trial for long-term efficacy and safety.
15758965|NCT04785352|Dietary Supplement|Nutrition Intervention|One egg per day for six months
15758966|NCT04785352|Behavioral|Grandi Byen|Multicomponent intervention on responsive parenting, nutrition, hygiene + one egg per day for 6 months
15758967|NCT04785339|Behavioral|intervention in adult Latinx immigrants|Participants will complete self-report outcome measures at pre (baseline) and post, and they will receive the intervention in-between these assessments. Thus, the time frame for data collection is 10 weeks.
15758968|NCT04785326|Drug|DMB-3115|45mg or 90mg dose subcutaneous administration
15758969|NCT04785326|Drug|Stelara|45mg or 90mg dose subcutaneous administration
15758970|NCT04785313|Biological|Retrievable Inferior Vena Cava Filters (IVCF)|Analysis anatomopathology of Retrievable Inferior Vena Cava Filters (IVCF) (ALN CF model).
15758971|NCT04785313|Other|Demographics data collection|Demographics data : age, gender, thromboembolic risk factors, Retrievable Inferior Vena Cava Filters (IVCF) (indication, dates of insertion and removal), and anticoagulant management during the period with filter.
15758972|NCT04785300|Drug|Dasatinib|100 mg capsule daily for 2 consecutive days administered orally every 15 days (2 days on drug, 13 days off) for 6 cycles
15758973|NCT04785300|Drug|Quercetin|Four 250 capsules once daily (total daily dosage 1000 mg) administered orally for 2 consecutive days every 15 days (2 days on drug, 13 days off) for 6 cycles
15758974|NCT04785287|Biological|Anti-CTLA4 Monoclonal Antibody BMS-986218|Given IV
15758975|NCT04785287|Biological|Nivolumab|Given IV
15758976|NCT04785287|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15758977|NCT04785274|Device|non-invasive hemoglobin (SpHb)|hemoglobin measuring device
15758978|NCT04785261|Drug|Methylhydroxypropylcellulose|1-2 drips each time, every 4 hours, for 12 weeks.
15758979|NCT04785261|Drug|Carbomer|1 drip each time, at bedtime, for 12 weeks.
15758980|NCT04785261|Drug|TCM Formula|6.0g Chi-Ju-Di-Huang-Wan plus 6.0g Jia-Wei-Xiao-Yao-San, 6.0g twice daily for 12 weeks.
15758981|NCT04785248|Procedure|Three-step disinfection|"Three step disinfection method can be divide in three part. The first step of disinfection: scalp dandruff removal + disinfection The second step of disinfection: whole head Use 2% iodine tincture to smear the whole head skin, the assistant helps to lift the head to expose the surgical field, from both eyebrows to the occipital hairline, from both sides to the neck, after the iodine tincture dry out, use 75% alcohol to deionize. Then placing more than 4 layers of operation towel under the head.
~The third step of disinfection: neck chest abdomen disinfection."
15758982|NCT04785235|Procedure|Non-Surgical Periodontal Therapy|
15758983|NCT04785222|Drug|dexmedetomidine 5 mcg mixed with 0.5% plain bupivacaine|Bilateral infraorbital nerve block with dexmedetomidine 5 mcg mixed with 0.5% plain bupivacaine, in total volume of 2 ml per side
15758984|NCT04785209|Other|Mean platelet volume, lymphocyte number, STEMI clinical risk scores|Lab parameters
15758985|NCT04785196|Drug|APG-115|Dose escalation of APG-115 in combination with label dose of toripalimab, four dose levels of APG-115 will be tested: 50, 100, 150, and 200mg. APG-115 will be administrated orally every other day (QOD) for consecutive 2 weeks (ie. dosed at Day 1, 3, 5, 7, 9, 11, and 13), with one week dosing off as 3 weeks a cycle.
15758986|NCT04785196|Drug|Toripalimab|Toripalimab is administrated following CDE approved label dose, i.e.: 240 mg intravenous infusion at Day 1 of every 3 weeks as a cycle.
15758987|NCT04785183|Dietary Supplement|Melatonin drops|Melatonin oral administration
15758988|NCT04785183|Other|Placebo|Oral 5% glucose
15758989|NCT04785170|Drug|Amino Acid|"A novel non-protein amino acid secreted by skeletal muscles which aids the cross-talk between skeletal muscles, liver, and adipose tissue at molecular levels. amino acid is generated by catabolism of the branched-chain amino acid valine. Existing literature states, amino acid induces body fat loss by increasing energy expenditure, stimulating free fatty acid (FFA) oxidation in the liver and skeletal muscle cell, and by enhancing oxygen consumption by adipose tissue and hepatocytes. It was observed that amino acid stimulated differentiation of energy storing white adipose tissue preadipocytes to an energy burning beige (brown to white) phenotype."
15758993|NCT04785157|Other|brain MRI assessment|structural/functional brain MRI assessment (PWI/DWI mismatch imaging, quantification of gray and white matter microstructural integrity, DTI, functional connectivity)
15758994|NCT04785157|Behavioral|neurocognitive assessment|multi-domains neurocognitive assessment
15758995|NCT04785144|Biological|mRNA-1273|Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike protein of the Wuhan-Hu-1 strain of SARS-CoV-2. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
15758996|NCT04785144|Biological|mRNA-1273.351|Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the pre fusion stabilized spike protein of the B.1.351 variant SARS-CoV-2 strain. mRNA-1273.351 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and PEG2000 DMG.
15758997|NCT04785131|Other|Prune|daily consumption of 50 grams prune.
15758998|NCT04785118|Drug|Hyoscine N Butylbromide|Patients will receive IV hyoscine butyl-bromide 20 mg in 2 ml, just before spinal anaesthesia.
15758999|NCT04785118|Drug|Ondansetron|Patients received IV ondansetron 4 mg in 2 ml, just before spinal anaesthesia.
15759000|NCT04785118|Drug|Saline|Patients received 2 ml of IV normal saline as a placebo just before spinal anaesthesia.
15759001|NCT04785105|Other|No intervention|No intervention
15759002|NCT04785092|Procedure|All Autologous Cartilage Regeneration|All patients will undergo firstly to a blood sampling and then to the arthroscopic debridement of the damage cartilage and subsequently will be harvested the surrounding healthy cartilage The harvested and healthy cartilage will shredded directly in situ with a shaver. This cartilage will then mixed with the patient's own Platelet Concentrate and may be injected directly into the cartilage defect. The Platelet Concentrate stimulates the healing of the cartilage most effectively. At the same time, the Platelet Concentrate will also used to produce autologous fibrin glue, which can be used to fix the applied cartilage chip / Platelet Concentrate product quickly and safely in the damaged cartilage.
15759003|NCT04785079|Procedure|Graston Instrument assisted Soft tissue Mobilization|Instrument assisted soft tissue mobilization using the Graston tool and technique for 3 minutes on each of the three locations
15759004|NCT04785066|Drug|Administration of dornase alfa|Patient treated for a cerebral thrombectomy will be administred dornase alfa treatment by intravenous
15759005|NCT04785053|Device|transcranial alternating current stimulation (tACS)|The tACS intervention (gamma stimulation, theta stimulation and active sham condition) will be administered to the participants over three visits that will be completed within one of the working days (Mon-Fri) at approximately the same time of day for all participants. Participants will be randomized and blinded to the tACS treatment.
15759006|NCT04785040|Other|The groups evaluated by The Musculoskeletal Pain Intensity and Interference Questionnaire for Professional Orchestra Musicians, Brief Pain Inventory, QuickDASH and Fatigue Severity Scale|The groups evaluated by The Musculoskeletal Pain Intensity and Interference Questionnaire for Professional Orchestra Musicians, Brief Pain Inventory, QuickDASH and Fatigue Severity Scale
15759007|NCT04785027|Drug|PSORI-CM01 formula|PSORI-CM01 formula will be orally administrated once a day for 12 weeks excpet the day for the infusion of AD-MSCs
15759008|NCT04785027|Drug|Gu Ben Hua Yu formula|Gu Ben Hua Yu formula will be orally administrated once a day for 12 weeks excpet the day for the infusion of AD-MSCs
15759009|NCT04785027|Biological|adipose-derived multipotent mesenchymal stem cells|AD-MSCs (adipose-derived multipotent mesenchymal stem cells) will be infused intravenously at a dose of 2 million cells/kg
15759010|NCT04785014|Procedure|interventional|In the aspirated group, the popliteal fossa areas were sterilized and BC content was aspirated from the popliteal fossa percutaneously under USG guidance with a 21-gauge needle (Figure 1). If the BC was septal, aspiration was performed from several different levels of the cyst so that the cyst content could be completely emptied.
15759011|NCT04784988|Drug|Adynovate|prophylaxis with Adynovate targeting a 12% FVIII through level based on PK assessment with my-PK-fit
15759012|NCT04784988|Drug|plasma derived or recombinant products containing FVIII|standard prophylaxis with plasma derived or recombinant products containing FVIII according to current guidelines
15759013|NCT04784975|Other|No intervention|No intervention
15759014|NCT04784962|Device|Revitive Medic Neuromuscular Stimulation Device|Usage of the Revitive NMES device - 2-6 sessions daily (1-3 hours per day).
15759015|NCT04784949|Procedure|portland cement|pulpotomy with PRF and white Portland cement
15759016|NCT04784949|Procedure|Mineral trioxide aggregate|pulpotomy with PRF and white Mineral trioxide aggregate
15759017|NCT04784949|Procedure|Biodentine|pulpotomy with PRF and Biodentine
15759018|NCT04784910|Drug|DWP14012 20mg|DWP14012 20mg, tablet, orally, once daily for up to 24 weeks
15759019|NCT04784910|Drug|Lansoprazole 15 mg|Lansoprazole 15mg capsule, orally, once daily for up to 24 weeks
15759020|NCT04784910|Drug|DWP14012 20mg placebo|DWP14012 20mg placebo-matching tablet, orally, once daily for up to 24 weeks
15759021|NCT04784910|Drug|Lansoprazole 15 mg placebo|Lansoprazole 15mg placebo matching capsule, orally, once daily for up to 24 weeks
15759022|NCT04784897|Drug|Brilacidin|Brilacidin IV infusion
15759023|NCT04784897|Drug|Placebo|Placebo IV infusion
15759024|NCT04784897|Drug|Standard of Care (SoC)|SoC therapies for COVID-19
15759025|NCT04784884|Device|HSI|diagnostic hyperspectral imaging
15759026|NCT04784871|Behavioral|5waysA Intervention|Web-based 10 week intervention, encouraging participants engaging in five potential health promoting activities: 1. Be active, 2. Take notice, 3. Keep learning, 4. Connect and 5. Give.
15759027|NCT04784871|Behavioral|5waysA Active wait-list control|Writing activity log in the waiting time. Then, after five months and the writing of activity log, the participants get the web-based intervention and SMS massages, which encourage the participants to engage in five potential health promoting activities: 1. Be active, 2. Take notice, 3. Keep learning, 4. Connect and 5. Give.
15759028|NCT04784871|Behavioral|5waysA Inactive wait-list control|No activity while the participants wait. After five months of waiting, the participants get the web-based intervention and SMS messages, which encourage participants engage in five potential health promoting activities: 1. Be active, 2. Take notice, 3. Keep learning, 4. Connect and 5. Give.
15759033|NCT04784832|Device|Paired Associative Stimulation|Combined magnetic and electric stimulation of cortex and nerve, respectively
15759034|NCT04784832|Device|Wrist|Short-term immobilization of the arm
15759035|NCT04784832|Device|Robotic arm|External perturbation of force field induced by robotic arm
15759036|NCT04784806|Other|Ground beef|Subjects will consume a 106g patty of cooked ground beef.
15759037|NCT04784806|Other|Ground pork|Subjects will consume a 118g patty of cooked ground pork
15759038|NCT04784806|Other|Tofu|Subjects will consume a 113g patty of cooked tofu
15759039|NCT04784806|Other|Beyond Meat|Subjects will consume a 113g BeyondMeat patty.
15759040|NCT04784793|Other|App-based group|"Participants received home exercise programs by a postural alignment exercise mobile app we developed.
~The postural alignment app included 3 main emerged themes were recorded as self-assessment, neck/shoulder, and upper back-specific exercise content, and motivational notifications.
~Participants can evaluate themselves in the application thanks to the self-assessment, receive motivational notifications during the day, and exercise reminders on the days determined by them. They can apply the exercise program with the formed exercise content videos.
~The exercise program consists of combined exercises that postural alignment plus exercises of neck spinal stabilization, stretching, and strengthening of neck/shoulders/upper back regions.
~Both group participants were requested to do the exercises from the app/brochure 3 times a week, for 6 weeks."
15759041|NCT04784793|Other|Control group|"Participants received home exercise programs as a paper handout.
~The exercise program was the same for app-based and control groups.
~Both group participants were requested to do the exercises from the app/brochure 3 times a week, for 6 weeks."
15759042|NCT04784780|Drug|Elobixibat 10mg|Patients with chronic constipation are administered Elobixibat 10mg for 12 weeks
15759043|NCT04784780|Drug|Placebo|Patients with chronic constipation are administered placebo for 12 weeks
15759044|NCT04784767|Biological|25 µg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant)|SpFN_1B-06-PL will be provided in a sterile, 2 mL single-use vial at 0.7 mL/vial, 90-110 ug/mL; ALFQ will be provided in a sterile 3 mL vial at 0.6 mL/vial
15759045|NCT04784767|Drug|Sodium chloride, USP, for injection (0.9% NaCl)|Normal saline will be provided in a sterile, single-use 10 mL vial
15759046|NCT04784767|Biological|50 µg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant)|SpFN_1B-06-PL will be provided in a sterile, 2 mL single-use vial at 0.7 mL/vial, 90-110 ug/mL; ALFQ will be provided in a sterile 3 mL vial at 0.6 mL/vial
15759047|NCT04784754|Drug|Melatonin|Melatonin capsules will be prepared using hypromellose capsules containing 3 mg or 30 mg of the active component and identical excipient (Microcrystalline Cellulose) used in the placebo preparation. Melatonin will be administered orally three times a day for 14 days.
15759048|NCT04784754|Drug|Placebo|Placebo capsules will be prepared using hypromellose capsules, filled using microcrystalline cellulose. This is the same excipient used in the preparation of the interventional drug. Placebo will be administered orally three times a day for 14 days in the same regimen used for the intervention.
15759049|NCT04784741|Other|Conventional static hamstring muscle stretching|Static stretching protocol had 10 repetitions in total with 15 seconds stretch time and 30 seconds relaxing time of hamstring muscle.
15759050|NCT04784741|Device|Low amplitude whole body vibration therapy|"Given five sessions of low amplitude whole body vibration therapy for duration of 10 minutes, on alternative days, along with static stretching of hamstring muscles.
~Static stretching protocol had 10 repetitions in total with 15 seconds stretch time and 30 seconds relaxing time of hamstring muscle."
15759051|NCT04784741|Device|Biodex Balance System|Pre and post balance assessment by Biodex balance system
15759052|NCT04784741|Procedure|Range of motion of hamstring muscle|Straight Leg Raising to check pre and post Range of Motion by using Goniometer
15759053|NCT04784728|Drug|Lidocaine topical system 1.8%|lidocaine patch
15759059|NCT04784689|Biological|COVID-19 Vaccine|COVID-19 Vaccine
15759060|NCT04784676|Other|restoration|indirect restoration
15759061|NCT04784663|Behavioral|Messaging|Four brief video messages, each approximately 1.5 minutes in length, focused on facilitating treatment seeking by addressing barriers and improving attitudes. Intervention delivered to participant by study mobile app downloaded to participants' own smartphone.
15759062|NCT04784663|Other|Wait list control|one push notification each week thanking individuals for participation, informing them that they will receive messages in the near future or reminding them of the length of the study.
15759063|NCT04784650|Other|Pre-dialysis population|Pre-dialysis population, consisting of both Diabetes Mellitus (DM) and non-DM patients
15759064|NCT04784637|Device|Web Simulation Tool (WST)|WST will allow users of the Control-IQ system replay treatment scenarios in computer simulation, thereby allowing user training with carbohydrate and insulin action.
15759065|NCT04784637|Device|Behavioral Adaptation Module (BAM)|BAM provides on-demand information to the participant primarily on glycemic risks.
15759066|NCT04784637|Device|Auto Titration Module (ATM)|ATM provides recommendations to the participant to periodically update insulin parameters.
15759067|NCT04784637|Device|Automated Insulin Delivery (AID) System|The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study.
15759068|NCT04784624|Behavioral|Lifestyle program|The cardiometabolic and weight loss program is based on The Wellness Institute clinically validated lifestyle medicine program and will be delivered virtually using a digital platform and artificial intelligence that is supported by a health coach. The program focuses on building individual's self-efficacy, motivation and importance to make and sustain healthy choices. The 16-week program begins with a health risk assessment and a personalized wellness plan. The plan includes a personalized exercise plan and nutrition strategy. Each user will regularly check-in with their personal health coach whose role is to provide expert advice and also empower, support and help make the user accountable as they build a healthy lifestyle. Coaching includes identifying obstacles to changing behaviors and how to develop new behaviors that will become the norm.
15823134|NCT04258982|Other|no intervention|no intervention
15759069|NCT04784611|Behavioral|Our Peers - Empowerment and Navigational Support (OP-ENS) Peer Health Navigator Intervention|Disability peer health navigator mentored and manualized process of barriers identification, asset mapping, goal setting, and action planning along with on-going social support and information sharing.
15759070|NCT04784598|Other|Insoles adapted in flip-flop sandals|participants of both groups individually received a pair of customized flip-flop sandals, with or without foot pieces, covered with smooth synthetic leather
15759071|NCT04784585|Behavioral|Enhanced Education|"The Enhanced Education intervention option seeks to: 1) enhance understanding of personal health-behavior links, 2) improve health literacy by checking the adequacy of participant understanding, and 3) remind participant of important elements of Behavioral Obesity Treatment (BOT) dietary goals."
15759072|NCT04784585|Behavioral|Self-Efficacy|"This intervention option is based on a previously established self-efficacy intervention for weight loss, which is a multi-component intervention for increasing self-efficacy. To provide variety in this intervention option and limit time spent in a single intervention, components are split into independent modules that either prompt: 1) attainable intention setting related to dietary adherence (e.g., I will focus on eating mostly fruits/vegetables in my next meal/snack in order to take back control of my eating); 2) barrier identification for adhering to dietary goals along with a brief problem-solving exercise; 3) devising a small self-reward; OR 4) self-assessment of thoughts/behaviors that could interfere with dietary adherence in the next several hours with coping strategies (e.g., stimulus control, social support)."
15759073|NCT04784585|Behavioral|Motivation|"To provide variety in this intervention option and limit time spent in a single intervention, components are split into independent modules that either: 1) guide participants in identifying values related to weight control (e.g., longevity, quality of life, being a role model) and connect those values to their behavior in the current moment.; 2) use a collaborative non-judgmental approach to explore the consequences of letting barriers drive behavior (e.g., Take a moment to consider the effect on your longevity if you let your preference for sweets determine your behavior.); 3) prompt participants to identify reasons for change, thereby eliciting change talk; OR 4) engage participants in a brief self-assessment of motivation for dietary adherence (i.e., On a scale of 1-10, how important to you is it to stick to your dietary goals today)."
15759074|NCT04784585|Behavioral|Self-Regulation|"There are 4 independent modules that prompt self-monitoring and self-awareness efforts: 1) advise participants to record everything that they eat before they eat it, with attention to eating in the subsequent few hours; 2) use the traffic light model to enhance awareness of dietary intake. This module provides the traffic light categories of foods (i.e., green=healthiest choices, yellow=sometimes choices, and red=rare choices), and asks participants to check-off foods that they intend to eat vs. stay away from in the next few hours; 3) advise participants to track portion sizes carefully and provide a portion size guide that is available to them until the following EMA survey; OR 4) provide a tutorial on noticing hunger/satiety cues and slowing down rate of eating, with an experiential exercise for use during their next eating episode."
15759075|NCT04784585|Behavioral|Generic Risk Alert (Active Comparator)|"Participants will be notified that the JITAI algorithm has determined heightened lapse risk in the following 2-3 hours (i.e., We have detected that your risk of lapsing from your weight loss diet is higher than usual and may require attention.)."
15759076|NCT04784585|Behavioral|Online Behavioral Obesity Treatment|The online BOT consists of: (a) 12 weekly multimedia lessons for training in behavioral weight loss skills; (b) online tools for self-monitoring weight, diet, and physical activity; and (c) weekly automated text-based feedback on progress to date. Participants are given a goal of losing 1-2lbs per week to achieve a total weight loss of ≥10% of initial body weight. Participants are prescribed a calorie goal of 1200-1800 kcal/day tailored on initial weight. Participants are given guidelines to follow a lowfat or Mediterranean diet to meet the prescribed calorie goal. Participants are given a physical activity goal tailored on initial activity level that gradually increases to 200 min/wk of activity, emphasizing brisk walking as the primary form of activity. They also receive a primer in self-monitoring weight, diet, and physical activity. Participants are instructed to self-monitor and follow the prescribed diet for the 6-month study period.
15759077|NCT04784572|Other|first injection delay and second injection delay|"During the first injection, the patient will make END scale for 5 seconds, EVAF scale for 10 seconds and insight scale for 5 minutes.
~The second injection the patient will make END scale for 5 seconds and EVAF scale for 10 seconds and then a maintenance."
15759082|NCT04784533|Drug|CTP-543|Oral dosing
15759083|NCT04784533|Drug|Placebo|Oral dosing
15759084|NCT04784520|Drug|HA121-28 tablets|HA121-28 600 mg, po, QD×21 days, every 4 weeks (28 days)
15759085|NCT04784507|Procedure|En Bloc Resection|En bloc transurethral resection of bladder tumor (EBR-BT) using any energy source (laser and bipolar or monopolar energy)
15759086|NCT04784507|Procedure|Conventional Transurethral Resection Bladder Tumor (Mono/Bipolar)|Conventional Transurethral Resection Bladder Tumor (Mono/Bipolar)
15759087|NCT04784494|Device|Magnetic Seizure Theapy (MagPro XP MST)|"MST treatment will be administered over the frontal/vertex cortex using 100 Hz stimulation using the MagPro XP MST with Cool TwinCoil. The MST determination of seizure threshold will be done using 100% machine output applied at 100 Hz at progressively escalating train durations, commencing at 2 seconds and increasing by 2 seconds with each subsequent stimulation until an adequate seizure is produced. During subsequent sessions, one stimulation will be delivered using a train duration that is 4 seconds longer than the train duration at threshold (with a maximum train duration of 10 seconds).
~MST treatments will be administered twice a week, for up to 16 treatments. This will be performed under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes."
15759088|NCT04784481|Drug|Ivermectin|Experimental Group received Ivermectin orally 4 tablets of 6 mg = 24 mg every 7 days for 4 weeks.
15759089|NCT04784468|Other|No intervention|Case-control design, one single investigation
15759090|NCT04784455|Drug|nomacopan (rVA576)|The study population will consist of paediatric patients who have undergone allogeneic or autologous HSCT and develop HSCT-TMA within 100 days of HSCT
15759091|NCT04784442|Drug|180mg of ETC-1002(bempedoic acid)|180mg, tablet, once daily, for 12 weeks
15759092|NCT04784442|Drug|120mg of ETC-1002(bempedoic acid)|120mg, tablet, once daily, for 12 weeks
15759093|NCT04784442|Drug|60mg of ETC-1002(bempedoic acid)|60mg, tablet, once daily, for 12 weeks
15759094|NCT04784442|Drug|Placebo|placebo, tablet, once daily, for 12 weeks
15759097|NCT04784416|Device|Active tPBM-2.0|The NIR pulsed wave (irradiance =300 mW/cm2) will be used. The duration or irradiation will be for ~11 minutes (666 seconds).
15759098|NCT04784416|Device|Sham tPBM-2.0|"The sham mode (0 mW/cm2) will be used. The duration or sham irradiation will be for ~11 minutes (666 seconds)."
15759099|NCT04784416|Drug|18F-MK-6240|PET tracer to be injected prior to PET imaging session, which will occur during baseline assessments
15759100|NCT04784403|Diagnostic Test|SARS-CoV-2 PCR and serology tests|Once the informed consent has been signed, the selected subjects must complete an epidemiological survey and go to a UB sample collection center to perform a PCR and serology test for SARS-CoV-2.
15759101|NCT04784390|Device|Binocular video games|Patients will play 1 hour of binocular video game of choice (Dig Rush and/or Monster Burner) a day 7 days a week for 8 to 12 weeks.
15759102|NCT04784390|Device|Patching of the sound eye|Patients will have their sound eye (fellow eye) patched 2 hours per day 7 days a week for 16 weeks.
15759103|NCT04784377|Other|high intensity laser in addition to traditional physical therapy exercises|"high intensity laser will be used with 1064 nm wavelength and maximum of 25 W power. Analgesic and biostimulant modes were used in the present study.
~Also the patients will receive traditional physical therapy exercises in the form of flexibility and strengthening exercises for shoulder muscles."
15759104|NCT04784377|Other|low level laser in addition to traditional physical therapy exercises|"patients will receive low level Laser Therapy in addition to traditional physical therapy exercises.
~diode laser device with a wavelength of 850nm, power output of 100mV, continuous wave and 0.07cm2 spot area laser will be used. The laser will be applied with a dosage of 5 joule/cm2 (totally 15-20 joule) at the most 5 painful points for 1 minute at each point over subacromial region of the shoulder.
~Also the patients will receive traditional physical therapy exercises in the form of flexibility and strengthening exercises for shoulder muscles."
15759105|NCT04784377|Other|traditional physical therapy exercises|Also the patients will receive traditional physical therapy exercises in the form of flexibility and strengthening exercises for shoulder muscles.
15759106|NCT04784338|Behavioral|Virtual shared medical visit|a shared medical visit done by zoom in a group, 1.5 hours
15759107|NCT04784338|Behavioral|Nutritional classes|A cooking class done by the teaching kitchen demonstrating cooking skills
15759108|NCT04784325|Diagnostic Test|Blood draw through TAP II|Two self-administered blood draws through TAP II device
15759109|NCT04784325|Diagnostic Test|Blood draw through ADx cardT|One self-administered ADx card blood draw
15759110|NCT04784325|Diagnostic Test|Blood draw through standard venipuncture|One phlebotomist-performed standard venipuncture
15759111|NCT04784312|Combination Product|9MW1411 injection|9MW1411 injection
15759112|NCT04784312|Combination Product|9MW1411 injection placebo|9MW1411 injection placebo
15759113|NCT04784299|Device|YVOIRE volume plus|Hyaluronic acid dermal filler
15759114|NCT04784299|Device|Restylane Lyft with Lidocaine|Hyaluronic acid dermal filler
15759115|NCT04784286|Other|Telemedicine 30-day post-op visit|Consented subjects randomized to the telemedicine visit arm will do their 30-day post-op visit via secure telemedicine video application through the Center of Connected Care. A survey will be asked via telephone about their post-op care visit, costs incurred, and feedback.
15759116|NCT04784286|Other|In-Person 30-day post-op visit|Consented subjects randomized to the in-person visit arm will physically come to a clinical visit with the bariatric surgery midlevel providers. A survey will be asked via telephone about their post-op care visit, costs incurred, and feedback.
15759117|NCT04784273|Procedure|Tibiotalocalcaneal Arthrodesis|Tibiotalocalcaneal (TTC) arthrodesis with a novel dynamic compression intramedullary nail.
15759118|NCT04784273|Device|DynaNail|Utilization of a novel dynamic compression pseudoelastic intramedullary nail
15759119|NCT04784260|Other|Microbiome analysis|Evaluate the bacterial composition in sperm from the different groups
15759120|NCT04784247|Drug|Lenvatinib|20mg daily (two 10mg lenvatinib capsules) taken orally
15759121|NCT04784247|Drug|Pembrolizumab|(200mg) will be administered as a 30-minute IV infusion, Q3W +/-3 days (infusions lasting between 25-40 minutes. Study treatment with pembrolizumab may be administered up to 3 days before or after the scheduled Day 1 of each cycle due to administrative reasons.
15759159|NCT04784026|Other|Dual tak gait assessment (motor+cognitive)|The dual task gait will be combined with a 10-meter walking test and a cognitive (1-back test) task and evaluated with the G-Walk portable device.
15759122|NCT04784234|Dietary Supplement|GlaucoCetin|GlaucoCetin, a medical food in capsule form, is FDA regulated and includes ingredients that have been shown to support and protect mitochondrial function of retinal ganglion cells. GlaucoCetin consists of a mixture of Curcumin, N-Acetyl Cysteine, Ginkgo Biloba Extract, Alpha-lipoic Acid, Citicoline, Grape Seed Extract, Green Tea Extract, and Coenzyme Q10. Additional ingredients include L-Taurine, Niacinamide, Biotin, Natural Astaxanthin, Fisetin, Quercetin, Luteolin, Proprietary Dragonberry Flavor Complex, Monk Fruit, Bitter Blocker Natural Flavor, Citric Acid, Silica Dioxide, Fibersol-2, L-Leucine. Many of these are known anti-inflammatory and antioxidant ingredients. A 6 month supply of capsules, made for this study, will be provided at randomization with the following instructions: Take 6 capsules by mouth once daily with food.
15759123|NCT04784234|Other|Placebo|The placebo is an identical capsule to the GlaucoCetin, made for this study, with no nutritional value. A 6 month supply of capsules will be provided at randomization with the following instructions: Take 6 capsules by mouth once daily with food.
15759124|NCT04784221|Radiation|Radiation by protontherapy associated to nanoparticles injection|"Treatment for the study will be based on proton therapy and the administration of AGuIX® nanoparticles.
~Protontherapy will be carried out for 4 consecutive weeks with 5 sessions per week (20 sessions) from D1 to D26.
~The administration of the AGuIX® nanoparticle will be done on Days 1, 8 and 15 during protontherapy"
15759125|NCT04784208|Diagnostic Test|Blood test for Thyroid stimulating hormone (TSH)|Blood test for Thyroid stimulating hormone (TSH)
15759126|NCT04784195|Behavioral|Observation|Verification of morfology and functionality of neck muscles
15759127|NCT04784182|Dietary Supplement|probiotic plus prebiotic supplement|Daily consumption of probiotic containing at least 5 billion CFU per day total bacteria including Lactobacillus helveticus and Bifidobacterium longum and prebiotic containing 4 grams of fructooligosaccharides (FOS)
15759128|NCT04784182|Dietary Supplement|placebo|Daily consumption of visually similar placebo pills
15759129|NCT04784169|Device|free middle turbinate flap|Repairing low flow leak using free middle turbinate flap
15759130|NCT04784169|Device|vascularized nasoseptal flap|Repairing low flow leak using fascia lata
15759131|NCT04784156|Procedure|Subtalar (Talocalcaneal) Arthrodesis|Subtalar (Talocalcaneal) arthrodesis with a novel sustained dynamic compression intramedullary nail
15759132|NCT04784156|Device|DynaNail Mini|Utilization of a novel sustained dynamic compression pseudoelastic intramedullary nail
15759133|NCT04784143|Drug|MDMA|3,4-methylenedioxymethamphetamine
15759134|NCT04784143|Behavioral|Psychotherapy|Standardized non-directive psychotherapy performed by therapist team
15759135|NCT04784130|Behavioral|Physical Activity|Respondents will complete activity logs (step count, using pedometer) and surveys (two items from the Summary of Diabetes Self-care activities measure) for physical activity.
15759136|NCT04784130|Behavioral|Medication Adherence|Respondents will provide information on their medication adherence using a survey (questionnaire - MMAS-8).
15759137|NCT04784130|Behavioral|Dietary Modification|Respondents will complete food logs and surveys (three items from the Summary of Diabetes Self-care activities measure) for dietary intake.
15759138|NCT04784117|Other|Dispatcher protocol change|In the beginning of 2019 dispatcher protocol was changed to shorten the time of death detection
15759139|NCT04784104|Drug|Bupivacaine HCl 0.5% Injectable Solution|30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml. (14 ml. bupivacaine, 14 ml. prilocaine and 2 ml saline with 5 mcg adrenaline per ml.)
15759140|NCT04784104|Drug|Prilocaine HCl 2% Injectable solution|30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml. (14 ml. bupivacaine, 14 ml. prilocaine and 2 ml saline with 5 mcg adrenaline per ml.)
15759141|NCT04784104|Drug|Adrenaline amp. 0.5 mg|30 ml of bupivacaine (Bupivacaine HCl %0.5) and prilocaine (Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5 mcg adrenaline per ml. (14 ml. bupivacaine, 14 ml. prilocaine and 2 ml saline with 5 mcg adrenaline per ml.)
15759142|NCT04784104|Procedure|Ultrasound guided supraclavicular block with coronal oblique method|The blocks will be performed by an experienced anesthesiologist with a USG guidence.
15759143|NCT04784104|Procedure|Ultrasound guided lateral sagittal infraclavicular block|The blocks will be performed by an experienced anesthesiologist with USG guidence.
15759144|NCT04784091|Drug|TP-03|TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day
15759145|NCT04784091|Drug|TP-03 Vehicle|Vehicle of TP-03 ophthalmic solution, administered twice a day
15759146|NCT04784078|Procedure|Coronary Angiography and Intervention|Transradial access puncture site
15759147|NCT04784065|Device|Hand orthosis|An orthosis applied to a hand affected by osteoarthritis with the expectation that it will improve symptoms and possibly structural progression.
15759148|NCT04784052|Drug|JSP191|Participants will receive a single IV dose at start of conditioning
15759149|NCT04784052|Device|CliniMACS Prodigy System|The device used to remove the αβ+T cells from donor stem cell transplant before being given to the recipient
15759150|NCT04784052|Biological|Depleted Stem Cell Transplant|TCRαβ+ T-cell/CD19+ B-cell depleted hematopoietic cells will be administered by IV after completion of conditioning regimen.
15759151|NCT04784052|Biological|Rabbit Anti-Thymoglobulin (rATG)|3 consecutive daily doses of rATG will be given by IV during conditioning
15759152|NCT04784052|Drug|Cyclophosphamide|4 consecutive daily doses of cyclophosphamid will be given by IV during conditioning
15759153|NCT04784052|Drug|Fludarabine|4 consecutive daily doses of fludarabine will be given by IV during conditioning
15759154|NCT04784052|Drug|Rituximab|1 dose of rituximab will be given at the end of conditioning
15759155|NCT04784039|Diagnostic Test|Transesophageal echocardiography|Patients randomized to the TEE group will be scheduled for cardioversion with prior TEE
15759156|NCT04784039|Diagnostic Test|D-Dimer analysis|Patients randomized to the DD-group will be scheduled for cardioversion with prior D-Dimer analysis. In case of positive D-Dimer results, TEE will be performed prior to cardioversion
15759157|NCT04784026|Other|Gait assessment (single)|The single walk will be evaluated with a 10-meter walking test and a G-Walk portable device.
15759158|NCT04784026|Other|Dual task gait assessment (motor+motor)|The dual task gait, 10-meter walking test and a motor (carrying a full water glass) will be combined with the task and evaluated with the G-Walk portable device.
15759160|NCT04784013|Procedure|Conventional CLOSE-guided pulmonary vein isolation|Point-by-point RF delivery will be performed aiming for a contiguous circle enclosing the veins. RF will be delivered in a temperature and flow-controlled mode (QMODE, target temperature 45°C, low flow temperature 40°C, cut-off temperature 50°C) with a power of 35W(posterior)/50W(anterior) (irrigation flow at 4-15ml/min). RF will be delivered until an ablation index (AI) of ≥400 at the posterior wall/roof/south pole and ≥550 at the anterior wall.
15759161|NCT04784013|Procedure|High power short duration pulmonary vein isolation|Point-by-point RF delivery will be performed aiming for a contiguous circle enclosing the veins. RF will be delivered in temperature-controlled mode (QMode+, target temperature 55°C, cut-off temperature 65°C) with a power of 90W (irrigation flow at 2-8ml/min). RF will be delivered for 4 sec at both the posterior and anterior wall.
15759162|NCT04784000|Drug|Period 1: AT-527 550 mg|AT-527 550 mg tablet (1 x 550 mg tablet, in the morning) on Day 1
15759163|NCT04784000|Drug|Period 2: carbamazepine|Carbamazepine 100 mg twice daily (BID) Days 3 to 6, 200 mg BID on Days 9 to 11, 300 mg BID on Days 12 to 25
15759164|NCT04784000|Drug|Period 3: AT-527 550 mg + carbamazepine|AT-527 550 mg tablet (1 x 550 mg tablet, in the morning) on Day 26 plus carbamazepine 300 mg BID on Day 26
15759165|NCT04784000|Drug|Period 3: AT-527 1100 mg + carbamazepine|AT-527 1100 mg tablet (2 x 550 mg tablets, in the morning) on Day 26 plus carbamazepine 300 mg BID on Day 26
15759166|NCT04783987|Other|Walking asessments|Gait parameters will be evaluated in single and dual task conditions with 10 Meter Walk Test and wireless digital miniature portable walking and movement analyzer.
15759167|NCT04783974|Device|Dental implants|Treatment of total or partial edentulism through the placement of osseointegrated dental implants
15759168|NCT04783961|Procedure|Cold snare endoscopic resection|Cold snare endoscopic resection
15759170|NCT04783935|Drug|Mavenclad®|No intervention will be administered as a part of this study. Participants who had received Mavenclad® up to 2 years (Year 1 and 2) in the parent study MS700568_0022 (NCT03364036) will be enrolled into this extension study and will be assessed up to 2 years follow-up (Year 3 and 4).
15759171|NCT04783909|Procedure|Phacoemulsification cataract surgery|All surgeries were performed using Infinity (Alcon Laboratories, Inc.) under topical anaesthesia by one surgeon through 2.2 mm incision in the upper corneal limbus. The hydroimplantation of IOL to the capsular bag was performed in all cases.
15759172|NCT04783883|Device|Modius decice (ML600)|Battery powered non-invasive neurostimulation device
15759173|NCT04783870|Drug|Dapagliflozin|Dapagliflozin 10 mg PO QD
15759174|NCT04783870|Drug|Placebo|Placebo
15759175|NCT04783857|Drug|Progesterone 200 MG Oral Capsule|Progesterone, 200mg, once daily, oral tablet/capsule
15759176|NCT04783857|Drug|Depot-Medroxyprogestereone Acetate|Depot medroxyprogesterone acetate intramuscular injection, once every 12 weeks
15759177|NCT04783857|Other|Placebo Oral Tablet|Placebo oral tablet, once per day
15759178|NCT04783857|Other|Placebo Injection|Placebo intramuscular injection, once every 12 weeks
15759179|NCT04783844|Diagnostic Test|Virtual modelization.|3D-MSP technology is used to make virtual 3D models based on conventional CT.
15759180|NCT04783831|Device|Biodegradable stent|Biodegradable stent (polymeric prostheses) is placed from the pancreatic duct to the jejunum. Duct-to-mucosa end-to-side anastomosis is performed for the pancreaticojejunal anastomosis.
15759181|NCT04783818|Radiation|Adjuvant Radiotherapy|PMRT
15759182|NCT04783805|Diagnostic Test|Conservative management with regular follow-up|Women will be followed-up every 4 months, with colposcopy and cytology at each visit.
15759183|NCT04783805|Procedure|Conization|Women with progression of HSIL, HSIL persistence after 24 months of follow-up, or that no longer meet the criteria for surveillance will have conization
15759184|NCT04783792|Dietary Supplement|Ascorbic acid / phytochemical supplement|Ascorbic acid / phytochemical supplement
15759185|NCT04783792|Dietary Supplement|Ascorbic acid|Ascorbic acid
15759186|NCT04783779|Device|Implant of STARgraft-2 shunt in the upper arm and subsequent use for hemodialysis access|After healing from the surgical procedure the graft will be routinely cannulated for hemodialysis sessions. Periodic evaluations of blood flow by ultrasound imaging will be made over the study period. Established standards of care will be followed as needed to maintain dialysis function.
15759187|NCT04783766|Drug|CK-3773274|CK-3773274- Tablets
15759188|NCT04783766|Drug|Placebo|Placebo- Tablets
15759189|NCT04783753|Drug|EDP-514|Subjects will receive EDP-514 on Days 1 and 14
15759190|NCT04783753|Drug|EDP-514|Subjects will receive EDP-514 on Days 1 and 23
15759191|NCT04783753|Drug|EDP-514|Subjects will receive EDP-514 on Days 1 and 8
15759192|NCT04783753|Drug|Itraconazole|Subjects will receive itraconazole QD for 14 days
15759193|NCT04783753|Drug|Carbamazepin|Subjects will receive carbamazepine BID for 23 days
15759194|NCT04783753|Drug|Quinidine|Subjects will receive quinidine BID for 8 days
15759195|NCT04783727|Diagnostic Test|Individualised treatment duration based on RNA transcriptomic model|Anti-MDR-TB treatment with standard drugs and individual treatment duration guided by the RNA transcriptomic model; may be shorter or longer than standard WHO-recommended treatment duration of 20 months.
15759196|NCT04783714|Dietary Supplement|Swisse Nutra+ Cholesterol Balance|Swisse Nutra+ Cholesterol Balance is a multi-ingredient nutraceutical composition contained in a brown soft-gel capsule format. Three capsules are required per dose.Swisse Nutra+ Cholesterol Balance is a multi-ingredient formulation containing artichoke extract, bergamot juice extract, hydroxytyrosol, an antioxidant derived from olive oil and sunflower oil-derived phytosterols. All ingredients target cholesterol reduction by different and complementing mechanisms, as evidenced by human clinical trials. These ingredients have been chosen to work synergistically to alleviate hypercholesterolemia and/or dyslipidemia through multiple pathways, whereby each ingredient works via a different mechanism to lower LDL-cholesterol in the body.
15759197|NCT04783714|Dietary Supplement|Placebo|Matched brown soft-gel capsule placebo containing olive oil and palm olein - no therapeutic benefit.
15759198|NCT04783688|Other|Full Face Snorkel Mask (FFSM)|A mask used for snorkeling that covers the entire face, as opposed to a conventional snorkel, which is held in the mouth only.
15759199|NCT04783675|Drug|Rituximab|Rituximab (375 mg/m2) will be given as a single intravenous infusion after remission
15759200|NCT04783662|Device|Intraoperative frontal electroencephalogram|Intra operative frontal electroencephalogram registration with 1 age adjusted Minimum Anesthetic Concentration of Sevoflurane
15759201|NCT04783649|Diagnostic Test|Papanicolaou cytological test|Cervical smear stained using conventional Papanicolaou technique.
15759202|NCT04783649|Diagnostic Test|Local cytological test (H&E stain)|Cervical smear stained using conventional hematoxylin and eosin staining techniques
15759203|NCT04783649|Diagnostic Test|Validated HPV DNA Test|Digene HC2 HPV DNA Test
15759204|NCT04783649|Diagnostic Test|Local HPV test|RealBest DNA HPV HR genotype (differential detection of human papillomavirus types 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59 DNA)
15759205|NCT04783649|Diagnostic Test|Colposcopy|Women with positive cytology results are referred to colposcopy and biopsy
15759206|NCT04783636|Drug|leuprorelin acetate 3.75mg|PT105, PT105R
15759207|NCT04783623|Procedure|Surgical endometrioma excision|We collect medical records of patients who had underwent surgical endometrioma excision at different sites in our hospital and conduct telephone or clinical interview
15759208|NCT04783610|Other|Ethanol|Ethanol will be administered via oral route.
15759209|NCT04783597|Diagnostic Test|Arterial Stiffness and Wave Reflection|Arterial stiffness and wave refection, a non-invasive test, will be collected and combined with standard clinical markers (blood biomarkers, ultrasound imaging) as well as medical and psychosocial questionnaires in order to test a comprehensive, multi-marker approach for pre-eclampsia prediction in high risk pregnant women.
15759210|NCT04783571|Other|Placebo|Auditory stimulation will not be delivered during the nap
15759211|NCT04783571|Other|Auditory Stimulation|Auditory stimulation will be delivered during the nap
15759212|NCT04783558|Behavioral|Mobile-based NAS Caregiving Tool|The information and skills training in the adapted NAS caregiving tool will be largely based on elements of Eat Sleep Console. Therefore, the NAS mobile tool intervention will incorporate non-intrusive caregiving skills and strategies that encompass providing a low stimulating environment (e.g., dimmed light and low noise), swaddling, continuous comfort and contact with caregiver, skin-to-skin contact, frequent breastfeeding/feeding, as well as novel components identified in the key informant interviews (e.g., preparing for stigma during delivery, CPS involvement, etc.).
15759213|NCT04783545|Drug|VLX-1005|VLX-1005 infusion
15759214|NCT04783545|Drug|Placebo|Placebo infusion
15759215|NCT04783532|Behavioral|Telehealth Mindfulness Program|Enrolled participants will participate in an individual (one-on-one) Telehealth-delivered (online with audio and video) mindfulness intervention with a trained mindfulness therapist. The intervention is adapted from mindfulness-based cognitive therapy and includes eight sessions lasting 75 minutes each (except the first session which lasts 90 minutes) over a 3-month period.
15759216|NCT04783519|Behavioral|Brief Behavioral Therapy for Insomnia (BBTI)|Brief Behavioral Therapy for Insomnia (BBTI) focuses primarily on stimulus control and sleep restriction as well as sleep hygiene recommendations delivered over 2 in-person sessions and 2 brief telephone boosters and is designed to be implemented by nonspecialists in primary care or other non-clinical settings. The intervention is manualized, and clients utilize sleep diaries and workbook assignments to consolidate recommendations.
15759217|NCT04783519|Behavioral|Brief Alcohol Screening and Intervention for College Students (BASICS)|Brief Alcohol Screening and Intervention for College Students (BASICS) is a manualized brief intervention targeting alcohol use and consequences among high risk drinkers and includes both personalized feedback regarding drinking norms, consequences, and motives for drinking, as well as protective behavioral skills for reducing heavy episodic drinking and related consequences. BASICS is delivered in a motivational interviewing (MI) style (Miller & Rollnick, 2002) to enhance intrinsic motivation to change drinking and implement protective behavioral strategies. BASICS has been adapted to target marijuana use and has been adapted for use with a variety of populations.
15759218|NCT04783506|Other|Observational Study|There is no intervention provided by this study. Observed for 12-month period using questionnaires and study visits.
15759219|NCT04783493|Device|Non-invasive magnetic stimulation of the spinal cord|Non-invasive transcutaneous magnetic stimulation of the dorsal spine will be applied by placing a circular magnetic coil (Magventure®️ MagPro®️ R20) on the skin, in the upper thoracic region (chest level T2-T3). The stimulation intensity will represent 100% of the motor threshold. The intermittent theta burst stimulation protocol will consist of 20 stimulation trains, with an interval of 8 seconds between trains, each train will have 20 bursts, and each burst will have 3 pulses at 50 Hz repeated at 5 Hz. In total, 1200 pulses will be applied for 3 minutes and 58 seconds
15759220|NCT04783493|Other|Coil will not be connected to the stimulation device|coil will not be connected to the stimulation device, and another active coil will be positioned about 15cm behind, far from its field of view, to provide idea from the sound stimulus that is being stimulated
15759221|NCT04783480|Other|Birthly|Women will receive a code to sign up for 3 free interactive childbirth education classes through the Birthly platform. They will be enrolled in 3 courses: Prenatal Education, Childcare and Breastfeeding. They will be encouraged to complete all courses prior to 36 weeks gestational age.
15759222|NCT04783480|Other|Standard of care|Subjects will participate in childbirth education at their own discretion.
15759224|NCT04783454|Other|Exercise program|educational video on training program design and healthy lifestyle 24 training sessions (12 on cardiovascular endurance training, 12 on mobility and strength)
15759225|NCT04783441|Device|Dexcom G6|access to continuous glucose monitoring in the Dexcom G6 arm 24/7
15759226|NCT04783441|Device|Dexcom G6 blinded sensor|retrospective access to continuous glucose profile after 10 days of wear
15759227|NCT04783428|Other|No intervention|Access to any treatment is through authorized commercial use and not as part of this DMP
15759228|NCT04783415|Drug|Acalabrutinib|Given PO
15759229|NCT04783415|Biological|Ublituximab|Given IV
15759230|NCT04783415|Drug|Umbralisib|Given PO
15759231|NCT04783402|Other|e-OTCAT program|"The e-OTCAT program consists of a combination of cognitive training in terms of attention, memory and processing speed; and adaptive training based on metacognition and cognitive-behavioral strategies (psycho-education, relaxation techniques training, stress management, energy conservation techniques, time management, etc.).
~This program also includes homework exercises consisting of a handbook of paper-and-pencil exercises, a cognitive training mobile app, and the practice of strategies seen in adaptive training sessions."
15759232|NCT04783402|Other|Educational handbook and standard care|At the beginning of chemotherapy, the participants will receive an educational handbook containing information about most frequent side-effects of cancer and cancer treatments, plus standard care.
15759235|NCT04783376|Drug|: Insulin, lispro and regular insulin|"A: the participant will have a mealtime bolus dose of fast-acting insulin 10 minutes before the meal representing 100% of the dose calculated according to the carbohydrate content of the meal and the individual insulin to carbohydrate ratio
~B: the bolus insulin dose for the meal will be calculated according to the carbohydrate content of the meal and the individual insulin to carbohydrate ratio and additional 30% of the calculated dose will added to cover the fat and protein content of the meal. This total dose will be divided into 2 portions. A premeal portion (60%) will be given 10 minutes before the meal and (40%) will be given 30 minutes after the premeal dose. Both doses will be given as fast-acting insulin.
~C: the same as intervention B but the 40% of the total dose will be given as regular insulin."
15759236|NCT04783363|Other|Snoezelen session|before one of two repeated invasive care
15759237|NCT04783350|Device|Transcranial alternating current stimulation (tACS)|tACS will be administered to the left angular gyrus at gamma frequency to improve cognitive functioning (MoCA score) and resting-state EEG signatures.
15759238|NCT04783337|Diagnostic Test|HR-pQCT (high resolution computertomograph)|In addition to determining the bone density, a quantitative bone structure analysis with measurement of the number of thickness and distribution of the trabeculae can also be carried out. In addition, the finite element analysis (FEA) allows strength models of the examined bone to be created from the data of the hr-pqCTs. In this way, the osseous consolidation of the fracture can not only be observed, but also tested for resilience with the help of mathematical models.
15759239|NCT04783337|Diagnostic Test|Blood withdrawal|Bone remodeling blood marker: S-CTX (Crosslaps), S-TRA5b ( tartrate-resistant acid phosphatase), S-PINP (Procollagen type 1 amino-terminal propeptide), BALP, Calcium, parathyroid hormone, 25-OH-Vitamin D3 (HPLC)
15759240|NCT04783324|Behavioral|E-Mobile Health Application|The e-mobile health application prepared by the researcher will be used. E-mobile health application include information about postpartum care.
15759241|NCT04783311|Biological|EuCorVac-19|Two intramuscular doses (0.5mL per dose) at 3-week interval
15759242|NCT04783311|Other|Normal Saline|Two intramuscular doses (0.5mL per dose) at 3-week interval
15759243|NCT04783298|Other|App|An application to deliver a series of behavioral questionnaires and decision-making game
15759244|NCT04783285|Behavioral|Individual cognitive stimulation therapy (iCST)|The intervention group will receive 32 individual CS sessions per participant. Each session will last approximately 45 minutes and will have the following structure: session introduction (5 minutes); reality orientation (10 minutes); stimulation of cognitive domain (25 minutes); session closure (5 minutes). The sessions will be led by a previously trained therapist. The intervention program will include several activities based on the principles of CS and adjusted for participants with psychotic disorders.
15759245|NCT04783272|Diagnostic Test|Photoacoustic Computed Tomography (PACT) Imaging|PACT will be completed prior surgery.
15759246|NCT04783259|Other|Structured approach|Structured approach with a narrow learning objective. The structured approach concerns a pre-escape room lecture and post-escape room debriefing
15759247|NCT04783246|Behavioral|Group Fitness|The group fitness intervention will involve streaming a group fitness class lead by a certified personal trainer. certified personal trainer and include variations of body-weight strength and aerobic exercise activities. Each work out session will be 30 minutes in duration and follow a structure of a warm-up period, alternating strength and aerobic exercises of varying intensity, and a cool-down period. The videos will be streamed to the group by a facilitator over Zoom video conferencing.
15759248|NCT04783246|Other|Nutrition education|The nutrition education intervention will involve 45-minute educational sessions involving didactic teaching, interactive goal setting, and a live cooking demonstration. Each session will be taught by a registered dietician who will also be responsible for designing the curriculum schedule.
15759249|NCT04783233|Biological|Chitosan succinamide|Chitogel will be tested for suitability as a packing material in tympanoplasty surgery.
15759250|NCT04783233|Biological|Gelfoam|Gelfoam is the current packing material for tympanoplasty surgery.
15759251|NCT04783220|Behavioral|Comprehensive structured parent intervention|"Educational sessions and coaching on infants' behavior cues
~Skills on motor stimulation
~Written instructions for play and stimulation activities at discharge
~Multidisciplinary follow-up
~Developmental tracking and advice via a mobile app"
15759254|NCT04783194|Drug|Dexamethasone+ Bupivacaine|Dexamethasone plus bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery.
15759255|NCT04783194|Drug|Bupivacaine|Bupivacaine in bilateral trans-incisional paravertebral block in lumbar spine surgery.
15759256|NCT04783181|Biological|AAV BBP-631|intravenous
15759257|NCT04783168|Other|Best Practice|Receive usual care
15759258|NCT04783168|Other|Health Promotion and Education|Install and use Fitbit app
15759259|NCT04783168|Other|Medical Device Usage and Evaluation|Use Fitbit to monitor step count
15759260|NCT04783168|Other|Quality-of-Life Assessment|Ancillary studies
15759261|NCT04783168|Other|Questionnaire Administration|Ancillary studies
15759262|NCT04783155|Device|POWERBreathe Plus®|Commercially available pressure-threshold device
15759263|NCT04783155|Other|Cardiopulmonary rehabilitation post lung transplant|Pulmonary function, lung diffusing capacity for carbon monoxide, inspiratory muscle strength, and diaphragm dimensions will be assessed in each patient. Each patient will also undergo a cardiopulmonary exercise test (CPET), 6 minute walk test, and an inspiratory muscle endurance test
15759264|NCT04783142|Other|High-fiber, low-protein diet|Diet will consist of at least 15g fiber above baseline and less than 10% of calories from protein.
15759265|NCT04783142|Other|Low-fiber, high-protein diet|Diet will consist of less than 15g fiber and greater than 18% of calories from protein
15759596|NCT04780386|Drug|NVP-1805|orally, once daily on Period 1 and Period 3 (or Period 2 and Period 4)
15759266|NCT04783129|Other|Education program based on 10 monthly lectures|The education program consist of 10 lectures on the management of motor and non-motor alterations associate with PD will be offered by a nurse, physiotherapist, occupational therapist, speech therapist, neurologist, lawyer, nutritionist, and psychologist.
15759267|NCT04783129|Other|No intervention|Participants will follow no education program (lecture) and will be instructed to follow their usual routine for the treatment of the disease
15759268|NCT04783116|Dietary Supplement|Plant stanols (3g/day)|Oral consumption of 6 plant stanol enriched chews per day for 6 months (total dosage is 3g/day). Chews are consumed with main meals: two with breakfast, two with lunch and two with dinner.
15759269|NCT04783116|Dietary Supplement|Placebo|Oral consumption of 6 placebo chews per day for 6 months. Chews are consumed with main meals: two with breakfast, two with lunch and two with dinner.
15759270|NCT04783103|Device|a Magstim Rapid2 Plus1 Magnetic Stimulator connected to a Brainsway H1 coil|3 weeks home use
15759271|NCT04783090|Drug|MT1013|bispecific peptide as a CaSR agonist and a functional OGP analogue
15759272|NCT04783077|Behavioral|WhatsApp|Participants assigned to the WhatsApp group will receive weekly messages developed by communication specialists aimed to motivate blood donation, be encouraged to discuss their blood donation experiences, and share their own motivations for donating blood in a moderated, closed group over a six-month duration. The moderator will provide guidelines on acceptable use of WhatsApp in the group, including images they can or cannot share. Participants will also receive standard NBSG communications for first-time donors.
15759273|NCT04783077|Behavioral|Control|Participants in this group will receive the standard NBSG communications for first-time donors: 1) a thank you phone call and 2) and a reminder phone call two-weeks prior to the second blood donation eligibility. The second blood donation eligibility is four months after the first donation.
15759274|NCT04783064|Procedure|Interscalene brachial plexus block|Interscalene brachial plexus block is performed at ipsilateral side of the affected shoulder.
15759275|NCT04783051|Drug|Sulfadoxine pyrimethamine|Intermittent Preventive Treatment in pregnant women with Sulfadoxine-Pyrimethamine
15759276|NCT04783051|Drug|Pyramax|Intermittent screening using ultra-sensitive malaria Rapid Diagnostic test and treatment using Pyronaridine - Artesunate (PYRAMAX®)
15759277|NCT04783038|Other|Distance Reiki|Reiki therapy session performed remotely over a Zoom® video conferencing platform led by Reiki Practitioners who are also Health Care Providers at the Mayo Clinic, and have at least 6 months of experience in Reiki.
15759278|NCT04783038|Other|Sham distance Reiki|Session performed remotely over a Zoom® video conferencing platform led by a Health Care Provider employed at the Mayo Clinic, but will have no experience in Reiki and will not be a certified Reiki Practitioner.
15759279|NCT04783025|Behavioral|Blended Gaming COVID-19 Training System (BGCTS)|"BGCTS is a blended training programme integrated with games and short video clips for Residential Care Home staffs to learn the principles of infection control and reinforce actions needed to stop the spread of COVID-19 within the RCHs, and to care for those residents suspected of having COVID-19. The contents of the training will refer to the evidence-based contents from The COVID-19 Risk Communication Package For Healthcare Facilities.
~Dosage of the intervention. Staffs are encouraged to learn each topic independently in 15 minutes. It will take a total of 120 minutes to complete all eight topics in 2 weeks. Staffs will attend two 30-minute face-to-face group sessions conducted by research nurse (and the Infection Control Officer of the RCH) to clarify concepts (one per week; after playing the games). Scores and progress bar will be shown to the staff so as a form of motivation to encourage continuous participation in the training."
15759280|NCT04783025|Behavioral|Usual care, infection control briefing|Participants in the CG will receive usual care, the infection control briefing given by the Infection Control Officer (ICO) of the RCHs to all staffs. Usually the briefing is irregular, non-standardized and determined by ICOs, depending on when the ICOs receive the information about infection control practice from Centre for Health Protection of the Hong Kong government. The format and duration of this briefing is determined by the ICO. Some ICOs deliver the infection control information in the form of posters or a written document, and circulate these materials to all staffs.
15759281|NCT04783012|Procedure|Catheter removal|Catheter management strategy after surgery
15759282|NCT04782999|Diagnostic Test|Oral Glucose Tolerance Test|Standard test of glucose tolerance with ingestion of 75 g glucose followed by blood sampling.
15759283|NCT04782999|Diagnostic Test|Hyperglycemic clamp with infusion of saline, GLP-1 or GIP|"Blood glucose kept at 15 mmol/L via iv 20% glucose infusions.
~Primed co-infusion of either:
~Saline
~GLP-1 (Prime dose 6 pmol/kg, infusion 1 pmol/kg/min)
~GIP (Prime dose 3 pmol/kg, infusion 1.5 pmol/kg/min)."
15759284|NCT04782986|Diagnostic Test|Pan-intestinal capsule endoscopy|Patients with iron deficiency anemia or overt GI bleeding with non-diagnostic upper GI endoscopy will be submitted to same-day pan-intestinal capsule endoscopy using PillCam Crohn's Capsule (Medtronic) followed by conventional colonoscopy under propofol sedation
15759285|NCT04782973|Other|AMAZE (TM) Disease Management Platform|Providing patients with smartphone app that will integrate with provider facing dashboard within electronic medical record.
15759286|NCT04782960|Drug|Iocal anaesthetic bupivacaine|Local anaesthetic Subconjunctival bupivacaine
15759287|NCT04782960|Drug|Placebo|0.9 saline
15759288|NCT04782934|Device|The YANG SENSOR is an active implantable device, for Real Time Continuous Glucose, Lactate and Ketone Measurement|The YANG SENSOR is an active implantable device, that is intended to be implanted in the subcutaneous abdominal tissue, approximately 10mm below the skin. The SENSOR is battery powered. The battery is wirelessly recharged through the skin by the YANGEXD, using a charging coil ('Donut') applied to the skin with an adhesive patch at the level of the SENSOR. The 'Donut' also receives data from the sensor.
15759289|NCT04782921|Device|Xenogenic bone graft material|After access to the periodontal defect via straight incision in vestibulum, at the mucogingival border or short releasing incision on adjacent tooth, Gel 40 (a mixture of collagen gel and xenogenic bone particles) or Gen-Os (pure xenogenic bone particles) will be inserted.
15759290|NCT04782908|Device|Transcatheter tricuspid valve edge-to-edge repair|Transcatheter tricuspid valve edge-to-edge repair is an interventional approach to treat severe tricuspid regurgitation. Under general anesthesia a clip delivery system is forwarded through the vena femoralis and right atrium in the right ventricle. A clip is deployed to clamp the tricuspid valve and reduce tricuspid valve regurgitation.
15759741|NCT04779177|Drug|Lumateperone 42 mg|Lumateperone 42 mg, oral administration
15759291|NCT04782895|Biological|Recombinant Human Papillomavirus Nonavalent (Types 6,11,16,18,31,33,45,52,58 )Vaccine(E.Coli)|Three doses administered intramuscularly at 0, 45 day and 6 month.
15759292|NCT04782895|Biological|Gardasil®9|Three doses administered intramuscularly at 0, 45 day and 6 month.
15759293|NCT04782882|Behavioral|Progressive muscle relaxation+laughter therapy|"Laughter therapy:Laughter therapy is a technique that changes the mood by breathing correctly and by combining childish exercises with laughter exercises to turn into real laughter for no reason.
~Progressive muscle relaxation procedure:
~the participants were asked to tighten and relax large muscle groups in the body with deep breathing exercises. Progressive muscle relaxation was applied to the muscles of the head and face, neck, chest, back, arms, hands, abdomen, hips, legs and feet. The procedure was applied in a dark environment and accompanied by candlelight and relaxing music."
15759294|NCT04782869|Device|transcranial direct current stimulation|Patients will be treated using Starstim 8 device, a device allowing to perform transcranial direct current stimulation. The position of electrodes will be personalized based on the localization of the epileptogenic zone.
15759295|NCT04782856|Drug|Levothyroxine|levothyroxine sodium tablet for oral use
15759296|NCT04782856|Drug|Liothyronine|Liothyronine sodium tablets for oral use treatment of hypothyroidism
15759297|NCT04782856|Drug|Placebo|inert sugar tablets for oral use blinding for treatment of hypothyroidism
15759298|NCT04782843|Other|HEP score assessement|Assessement of the HEP score between 2 physician.
15759299|NCT04782830|Device|Accelerometer|A uniaxial accelerometer-based activity monitor (ActivpalTM) will be worn by participants on one of the thighs during the 7 days of the placebo and treatment periods.
15759300|NCT04782830|Drug|placebo pill|Placebo pill will be taken for 7 days at the same frequency as their regular treatment with either midodrine or atomoxetine.
15759301|NCT04782830|Drug|Midodrine or atomoxetine pill|Either midodrine or atomoxetine at their regular dose.
15759302|NCT04782817|Other|Recommendation for high flow nasal cannula oxygen therapy order set|Participants will be assigned post extubation physician order set which recommends the administration of oxygen therapy via HFNC. HFNC is a heated and humidified system that allows prescribed fraction of inspired oxygen (FIO2) levels to be delivered at very high flow rates.
15759303|NCT04782817|Other|Provider choice standard care order set|Participants will receive order set with provider choice of standard care therapy.
15759304|NCT04782804|Drug|Capecitabine|Capecitabine+PD-1 Antibody（Tislelizumab）as Adjuvant Therapy Oral capecitabine (1250 mg/m²) was given post operatively twice a day on days 1 to 14 of a 3-weekly cycle for 24 weeks (eight cycles), and observation commenced within 16 weeks of surgery.
15759305|NCT04782804|Drug|PD-1 Antibody（Tislelizumab）|PD-1 Antibody（Tislelizumab, 200mg） was given q3w iv.
15759306|NCT04782791|Drug|Nivolumab plus SOX|The preoperative therapy consists of three-week cycles of intravenously administered nivolumab 360mg and oxaliplatin 130mg/m2 on day 1, and orally administered S-1 40-60 mg twice a day (BID) on day 1 to 14. The dose of S-1 depends on body surface area (BSA): BSA<1.25 m2, 40mg; 1.25<BSA<1.50 m2, 50mg; BSA>1.50 m2, 60mg. Day 15 to day 21 is the rest period.
15759307|NCT04782791|Drug|Nivolumab|The preoperative therapy consists of three-week cycles of intravenously administered nivolumab 360mg on day 1.
15759308|NCT04782791|Procedure|Gastrectomy|A standard D2 radical laparoscopic gastrectomy according to the CSCO clinical guidelines for the diagnosis and treatment of gastric cancer is planned 3-4 weeks after the last cycle of preoperative therapy.
15759309|NCT04782778|Drug|Bupivacaine 0.25% Injectable Solution|1 mg/kg Bupivacaine (0.25%)
15759310|NCT04782765|Drug|Camrelizumab+Chemotherapy+Chemoradiotherapy|Patients received neoadjuvant Camrelizumab 200mg combined with chemotherapy (Cisplatin 20mg/m2, Day 1-3, Docetaxel 75mg/m2, Day 1) for 2 cycles every 21 days, followed by concurrent chemoradiotherapy with Camrelizumab monotherapy maintenance
15759311|NCT04782752|Radiation|Radiation: Varying Doses of RT|3+3 radiation dose escalation model to see the maximum tolerated dose
15759312|NCT04782739|Other|None - Descriptive study|Descriptive study
15759313|NCT04782726|Other|Software Solution for Radiation Therapy Treatment|Software has been developed for individualized pre optimization evaluation of the patient anatomy and prescribed dose of radiation therapy.
15759314|NCT04782726|Other|Radiation therapy|Standard of Care planning for Radiation therapy is used to treat the subjects for head and neck cancer
15759315|NCT04782713|Other|Completing surveys|Completing surveys at baseline, 3, 6, 9, and 12 months
15759316|NCT04782700|Other|Steroid Taper (Prednisone)|The patients randomized to the steroid group will be prescribed prednisone PO or an equivalent corticosteroid at a dose of 0.5 mg/kg/day for 4 weeks ((plus BACTRIM-DS (1PO qd. 160/800mg) as prophylaxis against infection - If patient have a sulfa allergy, their physician will prescribe atovaquone 1500mg qd instead of Bactrim) and followed by a gradual taper of 0.25 mg/kg/day for 4 weeks, followed by 0.125 mg/kg qd for 4 weeks.
15759321|NCT04782674|Diagnostic Test|Saliva Testing|Saliva EBV-DNA Detection comparing with PBMC and plasma EBV-DNA
15759324|NCT04782648|Procedure|transit bipartition|transit bipartition as revisional bariatric surgery for weight regain after sleeve gastrectomy
15759384|NCT04782206|Procedure|superior hypogastric plexus block|superior hypogastric plexus chemical neurolysis
15759461|NCT04781569|Diagnostic Test|Intraoperative tissue samples|Intraoperative tissue samples from the site of infection during surgery will be taken in the patient.
15759325|NCT04782635|Device|mobile based application|Application basic function would be support and improve nutrition status of children. Personalization of goals and challenges, daily intake of calories, carbohydrates, proteins, fats, minerals and vitamins will be tracked, food logging, food tracking, meal and supplement reminders, recipes, visual cues (remaining calories) will be notified, episodes of vomiting, meals missed, diarrhea, nausea will be recorded , meal planned according to the food preferences of child, food composition table, nutrition blogs and articles
15759326|NCT04782635|Behavioral|Pamphlet|A pamphlet which will be provide knowledge to the patients
15759327|NCT04782622|Drug|Apatinib+Camrelizumab|Apatinib 250mg po qd+Camrelizumab 200mg ivdrip q14d
15759328|NCT04782609|Drug|Icapamespib|to test the safety, tolerability and pharmacokinetics of single agent oral icapamespib in patients with recurrent brain lesions.
15759329|NCT04782596|Procedure|Posterium nasal septum resection|Posterium nasal septum resection is required to ensure approach during transnasal endoscopic pituitary surgery in patients with pituitary adenoma.
15759330|NCT04782583|Other|Questionnaire|questionnaire for the patients and the volontaire
15759331|NCT04782570|Device|Verum TMS|Intensity of 100% of the resting motor threshold with iTBS. 600 stimuli applied in bursts of three pulses at 50 Hz given every 200 ms. iTBS will be applied 20 times for 2 s every 10 s.
15759332|NCT04782570|Device|Sham TMS|Sham stimulation with same protocol, but without magnetic stimulation
15759333|NCT04782557|Diagnostic Test|EUS-guided portal vein and hepatic vein aspiration|EUS-guided portal vein and hepatic vein aspiration
15759334|NCT04782544|Other|Buttermilk Powder|Treatment with 5.0 g of buttermilk powder daily for 10 weeks.
15759335|NCT04782544|Other|Anhydrous Milk Fat|Treatment with 5.0 g of milk powder (90% anhydrous milk fat, 10% buttermilk powder) daily for 10 weeks.
15759336|NCT04782531|Other|peripheral ECG|Subjects will be placed in supine position. The systematic use of a headset will reduce the noise inherent to the machine. A cardiac synchronization system using peripheral ECG allows the synchronization with the subject's heart rate.
15759337|NCT04782531|Other|Standard MRI|Standard MRI examination using a torso coil consists of morphological and phase-contrast flow sequences(standard and EPI acquisitions).
15759338|NCT04782505|Drug|DWJ1248|Camostat mesylate Tablet from Daewoong
15759339|NCT04782492|Procedure|graft configuration in coronary artery bypass grafting|Saphenous vein could be used as Y-composite graft or aortocoronary conduit during coronary artery bypass grafting
15759340|NCT04782479|Procedure|hand position|For tracheal intubation with a stylet for a manikin, one time, the position of the hand holding the tube was placed in the air, and the other time, the position of the hand holding the tube was placed on the cheek of the patient, while the assistant pulling back the stylet.
15759341|NCT04782466|Behavioral|Physical Activity (PA) Intervention|The ATOMIC intervention consists of four primary components: one-on-one chats with a PA coach, informational posts, PA self-monitoring through an activity tracker and educational modules regarding different aspects of becoming PA delivered through the MS-specific PA app. An overarching goal of moving youth with MS towards meeting current Moderate to Vigorous Physical Activity (MVPA) recommendations will be used in addition to initial results from accelerometer monitoring and evaluation of current PA intentions to establish step goals, with planned weekly incremental increases (10% weekly to goal).
15759342|NCT04782466|Behavioral|Waitlist attention-control|For a period of 6-months, participants will receive the control conditions that involve contact from study personnel and a nutritional educational module to ensure equivalent social contact in both arms of the study. After the 6-months, participants will receive the same intervention as the intervention arm.
15759343|NCT04782453|Behavioral|ToQuit, a technology delivered tobacco cessation intervention|"The intervention messages will consist of specific content areas derived from the formative research of the study. Some of the components of the intervention include
~Psychoeducation about consequences of tobacco use and benefits of quitting;
~goal setting;
~managing goals and self-monitoring of behavior;
~avoidance strategies;
~self-awareness and reflection messages;
~social and pharmacological support, and help-seeking;
~identifying and managing cravings;
~relapse prevention strategies."
15759344|NCT04782453|Behavioral|Tobacco quitting helplines|Participants from the control group will be sent the details of other functional tobacco helplines in India.
15759345|NCT04782440|Other|Telerehabilitaton|Patients will receive telerehabilitation sessions that include strengthening, stretching and range of motion exercises
15759346|NCT04782440|Other|Home exercise|Patients will be given a home-based exercise program without telerehabilitation supervision
15759347|NCT04782427|Other|COVID-19 infection|Case of nosocomial infection within the long-term care facility
15759348|NCT04782414|Procedure|Hot AXIOS® prosthesis|endoscopic trans digestive drainage using of the Hot AXIOS prosthesis in the treatment of pancreatic collections (incompletely fluid or necrotic)
15759349|NCT04782401|Other|Ultrasound guided genicular nerve block + exercise treatment|This method was used to inject a total of 6 mL of lidocaine plus 40 mg of triamcinolone (TA) at 3 separate target sites: the superior lateral, superior medial, and inferior medial genicular nerves plus exercise treatment
15759350|NCT04782401|Device|Physical therapy + exercise treatment|Ten sessions of hotpack as a surface warmer, TENS as a analgezic current, ultrasound therapy as a deep warmer and exercise treatment.
15759351|NCT04782388|Drug|Alprazolam|Study participants will receive Staccato alprazolam at prespecified time-point.
15759352|NCT04782388|Other|Placebo|Study participants will receive Staccato placebo at prespecified time-point.
15759353|NCT04782375|Other|Stop group|discontinue antiviral treatment
15759354|NCT04782375|Drug|Continue group|continue antiviral treatment
15759385|NCT04782206|Procedure|pulsed radiofrequency at S3 root plus superior hypogastric plexus block|pulsed radiofrequency neuromodulation at S3 root plus superior hypogastric plexus chemical neurolysis
15759386|NCT04782193|Biological|CD19 and CD22 targeted prime CAR- T cells|A single infusion of CD19 and CD22 prime CAR-T cells will be administered intravenously
15759387|NCT04782180|Drug|Descovy 200Mg 25Mg Tablet|daily Descovy tab by mouth
15759388|NCT04782180|Behavioral|PrEP|PrEP will be provided in a community setting by community-based harm reduction program.
15759389|NCT04782167|Behavioral|BRACE|BRACE is an interventional protocol that combines different strategies of balance training
15759356|NCT04782349|Other|mulligan mobilization with low level laser therapy and traditional physical therapy exercises|"for mulligan mobilization: for improving the limited range of motion of shoulder joint, the therapist will apply posterolateral mobilization for the shoulder joint. Three sets of painless glides of 10 repetitions will be applied with a rest interval of 30 s between each set.
~For low level laser application: Laser specifications is as follows: 850 nm wave length and pulsed application with 8 W applied for 20 minutes. laser will be applied over painful points of the shoulder.
~For traditional physical therapy exercises: the patients will receive the following exercise program: self stretching exercises for shoulder joint, pully exercises, back climbing exercises, finger ladder exercises, circumduction exercises and pendulum exercises"
15759357|NCT04782349|Other|low level laser therapy and traditional physical therapy exercises|patients in this group will receive low level laser and traditional physical exercises as described before for group (A)
15759358|NCT04782349|Other|physical therapy exercises|The patients will receive traditional physical therapy exercises only as described before for group (A)
15759359|NCT04782336|Other|Group A (Sample Collection)|"Sample Collection - Adult Population:
~Two (2) Nasal AND/OR
~Two (2) Throat Swabs AND/OR
~One (1) Saliva Sample
~Sample Collection - Paediatric Population:
~Two (2) Nasal OR
~Two (2) Throat Swabs AND/OR
~One (1) Saliva Sample"
15759360|NCT04782336|Other|Group B (Sample Collection)|"Sample Collection - Adult Population:
~Two (2) Nasal AND/OR
~Two (2) Throat Swabs AND/OR
~One (1) Saliva Sample
~Sample Collection - Paediatric Population:
~Two (2) Nasal OR
~Two (2) Throat Swabs AND/OR
~One (1) Saliva Sample"
15759361|NCT04782336|Diagnostic Test|On-Site Testing (LumiraDx)|Collected samples may be tested using a LumiraDx POC assay at a selection of sites, prior to being transferred to LumiraDx or one of its approved designees for in-house use, in the development and performance testing of the LumiraDx Influenza A/B, SARS-CoV-2 & RSV assays.
15759362|NCT04782323|Drug|aQII-1|Biological/Vaccine: Investigational aQII-1 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
15759363|NCT04782323|Drug|aQII-3 Investigational|Biological/Vaccine: Investigational aQII-3 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
15759364|NCT04782323|Drug|aQII-6 Investigational|Biological/Vaccine: Investigational aQII-6 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
15759365|NCT04782323|Other|aQII-7 Investigational|Biological/Vaccine: Investigational aQII-7 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
15759366|NCT04782323|Drug|aQII-9 Investigational|Biological/Vaccine: Investigational aQII-9 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
15759367|NCT04782323|Drug|aQII-10 Investigational|Biological/Vaccine: Investigational aQII-10 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
15759368|NCT04782323|Drug|aQII-11 Investigational|Biological/Vaccine: Investigational aQII-11 Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
15759369|NCT04782323|Drug|QII Active Comparator|Biological/Vaccine: Investigational QII Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
15759370|NCT04782310|Drug|Pregabalin|Pregabalin 75mg two hour preoperatively, 12 hours postoperative and will continue for one week twice per day.
15759371|NCT04782310|Drug|Duloxetine|Duloxetine 30mg two hour preoperatively …will be continued for one week once per day after breakfast .
15759372|NCT04782297|Device|Long term hemodialysis catheter|There will be no interventions in this study. Strictly observational.
15759373|NCT04782284|Other|Comprehensive swallowing rehabilitation|The treatment time per session is 30 minutes. Total 12 sessions are provided for 6 weeks.
15759374|NCT04782284|Other|Swallowing education|The education is 30 minutes. Total 1 session is provided immediately after baseline evaluation.
15759375|NCT04782271|Drug|SYL18001 sodium Low dose q.d|1 drop in the randomized eye once daily
15759376|NCT04782271|Drug|SYL18001 sodium Middle dose q.d|1 drop in the randomized eye once daily
15759377|NCT04782271|Drug|SYL18001 sodium High dose q.d|1 drop in the randomized eye once daily
15759378|NCT04782271|Drug|SYL18001 sodium High dose b.i.d|1 drop in the randomized eye twice daily
15759379|NCT04782258|Drug|Tolvaptan Suspension|Tolvaptan suspension will be administered orally or via nasogastric tube at doses of 0.15 mg/kg once daily in the AM, 0.30 mg/kg once daily in the AM, 0.5 mg/kg once daily in the AM, 0.75 mg/kg split dose (0.5 mg/kg AM and 0.25 mg/kg 8 hours later), and 1 mg/kg split dose (0.67 mg/kg AM and 0.33 mg/kg 8 hours later) based on age. Treatment duration is 18 months.
15759380|NCT04782258|Drug|Tolvaptan Tablets|Tolvaptan (OPC-41061) Tolvaptan tablets will be administered orally as split-dose regimens (15/7.5 mg, 30/15 mg, and 45/15 mg) upon awakening and 8 hours later based on weight if able to swallow tablets. Treatment duration is 18 months.
15759381|NCT04782245|Drug|Dapagliflozin 10mg|The intervention group will receive, during 6 months, dapagliflozin per oral route at a dose of 10 mg once daily in addition to the optimal medical management based on current heart failure practice guidelines.
15759382|NCT04782245|Drug|Placebo|Patients randomized in the control group will receive during 6 months, placebo once daily per oral route, in addition to the optimal medical management based on current heart failure practice guidelines.
15759383|NCT04782232|Other|No intervention|No intervention due to observational design
15759390|NCT04782141|Procedure|hand motor coordination in a sitting positin|The subject sat on the therapeutic table (without back support), feet resting on the floor. The upper limb was examined in adduction, with the elbow bent in the intermediate position between pronation and supination of the forearm. Wrist and a hand free from stabilization.
15759391|NCT04782141|Procedure|hand motor coordination in a supine position with the upper extremity positioned perpendicularly to the trunk|motor tasks carried out in starting positions: supine with the upper extremity positioned perpendicularly to the trunk; the upper limb in adduction and flexion in the humeral joint, elbow extension, forearm in the intermediate position; elbow, wrist, hand free from stabilization.
15759392|NCT04782141|Procedure|hand motor coordination in a supine position with adduction in the humeral joint, elbow flexion in the intermediate position|In the supine position, the upper limb was held beside the subject's body (adduction in the humeral joint, elbow flexion in the intermediate position between pronation and supination of the forearm. Wrist and a hand free from stabilization.
15759393|NCT04782128|Biological|RC28-E injection|a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF
15759394|NCT04782115|Biological|intravitreal injection of RC28-E|a chimric decoy receptor trap fusion protein by dual blockage of VEGF and FGF
15759395|NCT04782115|Biological|Conbercept|KH902(Conbercept）
15759396|NCT04782102|Behavioral|SOPHIE Intervention|SOPHIE is an online-intervention aiming to reduce social anxiety in adolescents. SOPHIE has 8 modules, one module per week, which lasts about 60 minutes. SOPHIE includes elements of evidence-based psychotherapeutic interventions to reduce social anxiety and of an existing online-intervention for adults with social anxiety adopted to the needs of adolescents. The intervention consists of psychoeducation (how social anxieties arise), application examples (e.g. setting up a personal anxiety cycle or anxiety pyramid, imagination exercise: journey to a safe place), and contains weekly tasks for which regular repetition in everyday life is important (e.g. progressive muscle relaxation, observing anxiety in everyday life, exposures in various situations). At the end of each module, a short quiz allows participants to recall and consolidate what they have learned. The content is presented in video inputs, short explanatory texts, application tasks and quizzes.
15759397|NCT04782089|Drug|Camrelizumab Anti-PD-1 antibody Fluzoparib PARP inhibitors|Camrelizumab+Fluzoparib：Q3W, Administration until disease progression or intolerable
15759398|NCT04782076|Drug|Dabigatran|Administered orally.
15759399|NCT04782076|Drug|Selpercatinib|Administered orally.
15759400|NCT04782063|Other|Calibration of infant breast milk and formula milk intake|We will calibrate (reduce) the pumped breast milk or formula intake of infants of overweight and obese mothers who exceed 75%ile of WHO BMI, in order to prevent infant obesity and subsequent childhood obesity.
15759401|NCT04782050|Device|Ultrasound liver assessment|The intervention consists in an ultrasound exam performed with the ultrasound medical device subject of the research.
15759402|NCT04782037|Drug|L-Methylfolate Calcium|Folic acid is one of the water-soluble B vitamins, which is synthetically-produced and found in fortified foods and supplements. It is essential for the synthesis and repair of DNA and RNA and metabolism of amino acids which are required for cell division. There is damage to the intestinal mucosa in most diarrhea cases; therefore, the role of folic acid has been studied as adjuvant therapy for diarrhea since folic acid plays an important role in the synthesis of DNA especially in rapidly regenerating cells.
15759403|NCT04782024|Dietary Supplement|7-Keto 50mg|
15759404|NCT04782024|Dietary Supplement|7-Keto 25mg|
15759405|NCT04782024|Dietary Supplement|Placebo|
15759406|NCT04782011|Behavioral|ATC/DDD|The intervention is the introduction of the ATC/DDD including the training on its importance and usage in monitoring antibiotic use at a given primary care facility.
15759407|NCT04781998|Drug|liraglutide 3 mg (Saxenda®) once-daily|Liraglutide 3 mg (Saxenda®) 6 mg/ml, 3 ml pre-filled pen-injector. The injection is administered subcutaneously. The initial daily dose will be 0.6 mg liraglutide (Saxenda®) for one week. If tolerated patients increase the dose by +0.6 mg each week until the full maintenance of 3 mg is reached (week 1: 0.6 mg, week 2: 1.2 mg, week 3: 1.8 mg, week 4: 2.4 mg, week 5-26: 3.0 mg. If necessary, a longer titration period is accepted). If the lowest tolerated dose is less than 1.8 mg of liraglutide (Saxenda®) once-daily after 12 weeks from inclusion, the patient will be excluded from the study.
15759408|NCT04781985|Procedure|cystoscopy|extraction of the bladder stone via suprapubic incision
15759409|NCT04781972|Drug|Methylphenidate|single dose of 10 mg or 15 mg
15759410|NCT04781972|Drug|Placebo|Matching placebo
15759411|NCT04781959|Drug|Filgrastim|Receive filgrastim subcutaneous injection once daily for five consecutive days starting 24-72 hours after chemotherapy
15759412|NCT04781959|Drug|Pegfilgrastim|Receive pegfilgrastim as a single dose subcutaneous injection 24-72 hours after chemotherapy
15759413|NCT04781946|Procedure|Endoscopic pneumatic balloon dilation|Using endoscopy, pneumatic balloon dilation may be used to treat stenosis of the gastric sleeve.
15759414|NCT04781946|Procedure|Gastric peroral endoscopic myotomy (G-POEM)|Gastric per-oral endoscopic myotomy (G-POEM) is a recent innovation offering a minimally invasive endoscopic approach. G-POEM allows for the creation of a tunnel and subsequent myotomy from the gastric cardia to the gastric pylorus.
15759415|NCT04781946|Procedure|Roux-en-Y gastric bypass (RYGB)|The Roux-en-Y gastric bypass is a type of weight-loss surgery that involves creating a small pouch from the stomach and connecting the newly created pouch directly to the small intestine.
15759416|NCT04781933|Dietary Supplement|Treatment with Combo|Treatment with Combo
15759417|NCT04781933|Other|Treatment with placebo|Treatment with placebo
15759418|NCT04781920|Other|datas collection|data collection in history medical : operative report, clinical examination, questionnaires, imaging, isokinetic tests
15759420|NCT04781881|Drug|Entresto|There is no treatment allocation. Patients administered Entresto by prescription that have started before inclusion of the patient into the study will be enrolled.
15759421|NCT04781868|Drug|Multi-nutrient supplement|Multi-nutrient supplement containing a combination of vitamins, minerals and antioxidants
15759422|NCT04781868|Drug|Placebo|Placebo
15759423|NCT04781855|Drug|Ibrutinib|Given PO
15759424|NCT04781855|Biological|Ipilimumab|Given IV
15759425|NCT04781855|Biological|Nivolumab|Given IV
15759426|NCT04781842|Other|Boxing exercise program|Participants attended an hour long class once a week for 12 weeks. Included in class was a warm up, boxing activities including weight shifting, kicking, and punching bags, strengthening activities and a cool down.
15759427|NCT04781829|Diagnostic Test|BioFire Pneumonia Panel|Treatment based on an algorithm that recommends antibiotic choices based on bacteria/virus detected by BioFire Pneumonia Panel
15759428|NCT04781816|Drug|SAR443122|Pharmaceutical form: Capsule Route of administration: Oral
15759429|NCT04781816|Drug|Placebo|Pharmaceutical form: Capsule Route of administration: Oral
15759430|NCT04781803|Drug|Cyclosporine|Cyclosporine 6 mg/kg and mycophenolic acid 1 gram orally on day 0 post-transplant
15759431|NCT04781790|Other|Bone Marrow Failure|without interventional intervention . biological collection in the routine care Standard of care of patients with bone marrow failure.
15759432|NCT04781777|Drug|insulin|sonar guided insulin combined with dexamethasone and local anesthetics
15759433|NCT04781764|Procedure|surgery|surgery
15759434|NCT04781751|Drug|insulin injection|Carpal tunnel syndrome sonagraphic injection
15759435|NCT04781738|Diagnostic Test|Cardiopulmonary exercise test|"CPET using a cycle ergometer (COSMED, Rome, Italy) beginning with no resistance warmup lasting 1-3 minutes followed with an incrementing resistance adapted to the patient's functional capacities according to the examiner's free judgment by successive stages
~Six minute walk test - patients will be instructed to walk as far as possible for six minutes in a 30-meter long enclosed corridor with a flat and hard surface, marked at every meter. Meters will be calculated at the end of the test.
~SF-36 is a questionnaire that contains eight domains - physical functioning (10 items); role limitations due to physical functioning (4 items); role limitations due to emotional problems (3 items); energy and vitality (4 items); mental health (5 items); social functioning (2 items); bodily pain (2 items); and general health perceptions (5 items).
~Scores are summed for each domain and were transformed into scores of between 0 (worst possible health state) to 100 (best possible health state)."
15759436|NCT04781725|Drug|INT230-6|INT230-6 is a formulation of two well known chemotherapeutic agents, cisplatin (0.5mg/mL) and vinblastine sulfate (0.1mg/mL), combined with 2-hydroxybenzoylaminooctanoate (also known as SHAO-FA or SHAO as a sodium salt at 10mg/mL).
15759437|NCT04781712|Behavioral|Modular mHealth for Tailored Rehabilitation|an individually tailored self-management through the mHealth app with a smart band worn on the wrist
15759438|NCT04781686|Drug|Camrelizumab|Camrelizumab (200mg) will be given i.v. on day 1 of each 3-week cycle
15759439|NCT04781686|Drug|Apatinib Mesylate|Apatinib (250mg) will be administered orally once a day .
15759440|NCT04781686|Drug|S1|S1 (BSA<1.25 40mg, BSA >=1.25-<1.5 50mg, BSA >=1.5 60mg) will be administered orally twice daily on days 1-7 of each 3-week cycle
15759441|NCT04781686|Drug|Docetaxel injection|Docetaxel (75mg/m2 IV.drop) will be administered on day 1 of each 3-week cycle, for six cycles.
15759442|NCT04781673|Drug|Ketamine|Will receive titratable infusion.
15759443|NCT04781673|Drug|Lidocaine|Will receive titratable infusion, will have daily lidocaine level labs drawn daily.
15759444|NCT04781660|Device|Implantable Alginate Hydrogel|"Implantable Alginate Hydrogel is a single use, multiple component device. It is expected to be used as a space-occupying material implanted into the myocardium to affect the shape of the left ventricle and reduce the clinical symptoms of patients with left ventricular ischemia and non-ischemic cardiomyopathy.
~The hydrogel serves as an artificial myocardial filler to stop the continuous expansion of the ventricle and restore it to a more favorable shape and size. The expected clinical effect of the Implanted Alginate Hydrogel is to reduce the clinical symptoms of patients and improve the quality of life by improving the structure and function of the failing heart."
15759445|NCT04781647|Drug|ABI-H0731|Participants will receive ABI-H0731 300 mg tablets orally once daily
15759446|NCT04781647|Drug|ETV|Participants will receive ETV 0.5 mg tablets orally once daily
15759447|NCT04781647|Biological|Peg-IFNα|Participants will receive Peg-IFNα with a starting dose of 180 µg solution by subcutaneous injection once weekly
15759448|NCT04781634|Biological|CD19 and CD22 targeted prime CAR-T cells|A single infusion of CD19 and CD22 prime CAR-T cells will be administered intravenously
15759449|NCT04781621|Other|Robotic Gait Training|Participants will wear an exoskeleton suit and receive robotic gait training with a physical therapist for 90 minutes each week. Robot gait training will include standing and walking activities while wearing a robot suit. Participants will be asked to completed questionnaires about walking and function. They will also be asked to wear a watch measuring their heart rate monitor.
15759450|NCT04781621|Other|Usual Care Gait Training|Participants receive usual care gait training with a physical therapist for 90 minutes each week. Usual care gait training may include standing and walking activities while using a treadmill or walker. Participants will be asked to completed questionnaires about walking and function. They will also be asked to wear a watch measuring their heart rate monitor and number of steps.
15759451|NCT04781608|Behavioral|English: In It Together (IIT)|Digital intervention program that consists of 4 modules, to be completed 1 week apart. The modules consist of psychoeducation, as well as acceptance and commitment therapy-inspired activities.
15759452|NCT04781595|Dietary Supplement|Watermelon|A single dose of watermelon powder containing 3g of L-citrulline
15759453|NCT04781595|Dietary Supplement|Beetroot|A single dose of beetroot powder containing 8 mmol of nitrate
15759454|NCT04781595|Dietary Supplement|Watermelon + beetroot|A single dose of watermelon and beetroot powder containing 3g of L-citrulline and 8 mmol of nitrate
15759455|NCT04781595|Dietary Supplement|Placebo|A single dose of maltodextrin
15759456|NCT04781582|Procedure|Lung volume reduction surgery|Surgical lung volume reduction
15759457|NCT04781582|Procedure|Bronchoscopic lung volume reduction|Bronchoscopic lung volume reduction by endobronchial valves
15759458|NCT04781569|Other|data collection|Health-related personal data such as year of birth, sex, Body Mass Index (BMI), infection classification, concomitant infections, comorbidities according to medical chart, standard diagnostic markers (CRP, blood differential plots, creatinine, ...), medication, treatment start, treatment end and discharge from hospital will be collected.
15759459|NCT04781569|Diagnostic Test|blood draw|2 blood drawing events (in total 22.5 ml) will be performed in the patient. 1 blood drawing events will be performed in the healthy proband.
15759460|NCT04781569|Diagnostic Test|nose swabs|2 nose swabs will be taken in the patient. 1 nose swab will be performed in the healthy proband.
15759462|NCT04781556|Other|No intervention|All patients treated between 01/01/2017 and 12/31/2018 in the Fracture sector will be screened through the computerized medical file. For patients who meet all the eligibility criteria, the information note, study questionnaire and a stamped envelope will be sent to them by post. Without feedback from him within 30 days of this submission, the patient is considered not to have objected to the study. The patient's information as well as his non-objection will be recorded in his medical file.
15759463|NCT04781543|Drug|HZN-825 BID|300 mg oral tablets BID
15759464|NCT04781543|Drug|Placebo|Placebo BID
15759465|NCT04781543|Drug|HZN-825 QD|300 mg oral tablets QD
15759466|NCT04781530|Device|BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus)|BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus): Nasopharyngeal swab
15759467|NCT04781504|Behavioral|Exercise|intervention groups will complete supervised virtual exercise sessions for 12 weeks using the platform preferred by the patient (Zoom care, Zoom business, Google duo, google meet, FaceTime, join.me, WhatsApp Call, etc). The appointment will be scheduled and conducted 2 days per week. The first class will be conducted on-site to teach the patient how to take vitals and to do an in-person exercise session
15759468|NCT04781491|Behavioral|Forest Therapy (Düppeler Forst - Berlin-Wannsee)|Forest Therapy means mindful visits in nature, actively perceiving the flora and fauna
15759471|NCT04781465|Device|Immersive Virtual Reality|"Dedicated virtual reality sessions.
~Duration 20 minutes per session.
~The virtual reality session will be supervised by a health professional trained in this tool after 1.5 hours of training by the team responsible for the equipment (use of the equipment, and use of the 20 minutes of VR). This supervising professional may be a doctor, an occupational therapist, a caregiver or any other health professional trained in the tool under this protocol.
~The exercises proposed will be standardized virtual reality exercises with the same exercises for all, but adapted to the level and abilities of each patient."
15759472|NCT04781452|Other|standard treatment|there ist no Intervention but our standart Treatment in the center
15759473|NCT04781439|Procedure|IV-to-PO conversion of antibiotics|IV-to-PO switching of antibiotics treatment
15759474|NCT04781426|Drug|Tenofovir Disoproxil Fumarate (TDF) 300 mg|PrEP regimens of Tenofovir Disoproxil Fumarate (TDF) 300 mg/Lamivudine (3TC) 300mg per oral (PO) daily
15759475|NCT04781413|Drug|Nab-PTX, Sintilimab, S-1|This is a single-arm study with all patients receiving these three drugs.
15759476|NCT04781400|Behavioral|Mobile phone support|Mobile phone support (SMS)
15759477|NCT04781400|Behavioral|Remote service delivery model|ART treatment delivery via a courier service
15759478|NCT04781387|Drug|CRS3123|Study drug dosed at 200 mg PO BID (treatment arm A) or 400 mg PO BID (treatment arm B) for total of 10 days
15759479|NCT04781387|Drug|Active Comparator|Active comparator is administered 125 mg PO QID
15759480|NCT04781374|Drug|Neratinib|Oral, once daily with 28 consecutive days defined as a treatment cycle, dosage per protocol ,
15759481|NCT04781361|Drug|Intravenous isotonic fluid - NaCl 131-154 mmol/L in 5% dextrose|Isotonic group will be given fluids containing 131-154 mmol/L Sodium Chloride
15759482|NCT04781361|Drug|Intravenous Hypotonic fluid- Sodium Chloride < 130 mmol/L|"Hypotonic group will be given fluids containing lower than 130 mmol/L :
~Dextrose 5% in 0.2% Sodium Chloride, or Dextrose 5% in 0.33 % Sodium Chloride,or Dextrose 5% in %0.45 Sodium Chloride, or Intravenous fluid containing Sodium Chloride < 130 mmol/L"
15759483|NCT04781348|Procedure|Platelet Rich Plasma plus fat grafting|The study participants fulfilling the inclusion criteria giving consent will be randomly divided into two groups, one group will receive only fat grafting whereas another group will receive Platelet Rich Plasma plus fat grafting.
15759484|NCT04781335|Drug|Dexycu|"This is a contra-lateral randomized study, meaning that in clinic after a patient is identified as a candidate we will flip a coin for selection of the eye that is going to receive the Dexycu™ implant (the implant will be placed intracapsularly at the optic haptic junction of the IOL). The patients will receive the SAME topical regimen (Eye with Dexycu™: no steroid, Eye without Dexycu™: steroid will be used). The Dexycu™, topical NSAID, and antibiotic regimen will be provided to all patients in the study, at no cost, in order to avoid difficulties with compliance, insurance, and follow up."
15759485|NCT04781335|Drug|Standard of Care post operative eye drops (steroid, antibiotic, NSAID)|"This is a contra-lateral randomized study, meaning that in clinic after a patient is identified as a candidate we will flip a coin for selection of the eye that is going to receive the Dexycu™ implant (the implant will be placed intracapsularly at the optic haptic junction of the IOL). The patients will receive the SAME topical regimen (Eye with Dexycu™: no steroid, Eye without Dexycu™: steroid will be used). The Dexycu™, topical NSAID, and antibiotic regimen will be provided to all patients in the study, at no cost, in order to avoid difficulties with compliance, insurance, and follow up."
15759488|NCT04781309|Drug|NT-I7|NT-I7 is a recombinant human interleukin-7 fused to a hybrid fragment crystallizable region of a human antibody (hyFc). NT-I6 has a molecular weight of 104 kD. The active moiety of NT-I7 is recombinant human interleukin-7 (rhIL-7), containing human IL-7 (amino acids 4 through 155) and exhibiting all known functions of endogenous human IL-7.
15759489|NCT04781296|Device|CT with a photon-counting detector|Enrolled subjects will complete an exam using the photon-counting CT, with or without IV contract as indicated. Images will then be compared with the previously acquired CT conducted as standard of care.
15759550|NCT04780776|Device|UVB treatment|5 weeks of UVB titration to determine individual's UVB sensitivity followed by 16 weeks of UVB exposure intervention
15759551|NCT04780776|Device|Sham comparator|5+16 weeks of visible light exposure
15759552|NCT04780763|Other|Milk product fermented by lactic bacteria or not fermented|2 bottles of 100g consumed daily during 28 days
15759553|NCT04780750|Drug|Docetaxel|Arm A (tested regimen): concurrent chemoradiotherapy with weekly docitaxel (20 mg\m2) and cisplatin (80mg\m2 every 3 weeks)
15759490|NCT04781283|Device|measurement of endothelial cell density by specular microscopy|"During this first appointment (T0), in addition to the usual treatment, measurement of the endothelial cell density by specular microscopy will be carried out on the affected eye (basal cell density). To overcome the variability linked to the machine, three consecutive measurements will be taken; the average of the three measurements will be used.
~As part of his post-operative follow-up, the patient will be reviewed at one month, one year, two years, three years, four years and five years after the operation. During these consultations and as part of the research, a new determination of the cell density (3 consecutive measurements) by specular microscopy of the operated eye and an evaluation of the position of the XEN implant will be carried out each time. ® by OCT scan for patients having undergone this surgery."
15759491|NCT04781270|Drug|mFOLFOXIRI regimen|oxaliplatin 85 mg/m2, irinotecan 165 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1
15759492|NCT04781270|Drug|mFOLFOX regimen|oxaliplatin 85 mg/m2, and folinic acid 400 mg/m2 followed by bolus 5-fluorouracil 400 mg/m2 and 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1
15759493|NCT04781270|Drug|Bevacizumab|5 mg/kg on day 1
15759494|NCT04781257|Diagnostic Test|New test candidates|"The following new diagnostic tests will be done after the completion of the study with the samples (blood, sputum, urine) and data (digital X-ray) obtained during the study period:
~CAD4TB / qXR Xpert Ultra® FLOW-TB TAM-TB 4RISK and COR Cepheid 3-gene signature cartridge BioMérieux ISIT TB blood transcription signature assay Multiplex LSHTM in-house host biomarker assay TB Screen biosignature SeroSelect
~Retrospective testing of participants' samples and data acquired during the study period, differentiated between participants with co-prevalent/incipient TB and participants staying health throughout the trial"
15759495|NCT04781244|Device|EndWarts® FREEZE|EndWarts® FREEZE is an alternative home cryotherapy device. Patients don't have to go to the hospital to receive treatment for their wart.
15759496|NCT04781244|Device|Liquid nitrogen|Liquid nitrogen is a conventional cryotherapy treatment for cutaneous wart performed by physician at the hospital.
15759497|NCT04781231|Device|MusicCare® device|The device consists of a headset and a touch pad. The patient can choose the style of music he prefers among 5. The 'U-shaped sequence' offered by MusicCare® is based on the principle of hypnoanalgesia. Musical induction is personalized according to the patient's preference. It will gradually lead to a hypnotic state of consciousness modified by variations in musical components such as rhythm, frequencies, orchestral formation and volume. A listening session lasts about 20 minutes.
15759498|NCT04781231|Device|Device with quiet recorded music|An mp3 device with headphones will be given to the patient. Caregivers will launch a quiet 20-minute music playlist
15759499|NCT04781231|Other|Usual management of anxiety|No specific intervention
15759500|NCT04781205|Genetic|Mutation arrays, NGS panels, GWAS, WES, WGS,|DNA extracted from peripheral blood as well as genetic analysis of bacteria from feces
15759501|NCT04781205|Device|wearable monitors|test various technologies of sensors to measure continuously various body functions and provide information to person and to physician
15759502|NCT04781192|Drug|Durvalumab|Intra-Venous(IV) once every 28 days (approximately every 4 weeks [q4w])
15759503|NCT04781192|Drug|Regorafenib|Oral once per day, Days 1 - 21 every 28 days
15759504|NCT04781179|Behavioral|CM-II|It is an intervention of 4 two-hour sessions with a psychologist, MC-II technique
15759505|NCT04781179|Behavioral|Psychoeducation|It is an intervention of 4 two-hour sessions with a psychologist, psychoeducation
15759506|NCT04781166|Behavioral|Calm program|7 online modules designed to teach cognitive behavioral skills
15759507|NCT04781153|Procedure|Periodontal treatment|Periodontal treatment (scaling and rootplaning) with adjunctive chlorhexidine use
15759508|NCT04781140|Drug|100mg SPN-812|100mg SPN-812 will be administered once daily and compared to Placebo
15759509|NCT04781140|Drug|Placebo|Placebo will be administered once daily
15759510|NCT04781127|Device|Soterix Medical mini-CT tDCS stimulator|Stimulation will last 30 minutes per day, 5 days per week, for 5 weeks, then 3 days per week for 1 week and then 1 day per week for 4 weeks.
15759511|NCT04781114|Drug|JS002|JS002: 150mg(1mL) Q2W; Placebo 1mL Q2W.
15759512|NCT04781114|Drug|Placebo|JS002: 300mg(2mL) Q4W; Placebo 2mL Q4W.
15759513|NCT04781101|Other|conventional therapy|Conventional therapy sessions that were planned by a physiotherapist for the children were conducted by a physiotherapist experienced in paediatrics. The therapy sessions mainly focused on functions such as the regulation of muscle tone, correction of posture, elimination of stiffness, muscle strengthening, balance/coordination training and mobilisation (Figure 2). The sessions were planned to last 40 minutes.
15759514|NCT04781101|Other|RoboGait®|The RoboGait®-assisted gait system was used for the robot-assisted gait training. In addition to conventional therapy, 16 robot-assisted gait training sessions were conducted, each lasting 25 minutes for 2 days a week (400 minutes in total). Gait speed was 1.5 km/h in all sessions. Considering conditions such as joint limitations and spasticity, gait training was performed with patients bearing 45% to 75% of their weight.
15759515|NCT04781088|Drug|Lenvatinib|Given PO
15759516|NCT04781088|Drug|Paclitaxel|Given IV
15759517|NCT04781088|Biological|Pembrolizumab|Given IV
15759518|NCT04781075|Other|Pain Scale|Maximum Daily Pain Scale will be recorded daily until discharge (typically under 7 days)
15759519|NCT04781075|Drug|Exparel Injectable Product|Given at the beginning of the surgery for post-operative pain management
15759520|NCT04781075|Drug|Bupivacaine Injection|Given at the beginning of the surgery for post-operative pain management
15759521|NCT04781062|Diagnostic Test|Blood and urine molecular analysis (Timing 0)|peripheral blood and urine sample collection
15759522|NCT04781062|Diagnostic Test|Blood and urine molecular analysis (Timing 1)|peripheral blood and urine sample collection
15759554|NCT04780737|Procedure|Cholecystectomy|Laparoscopic or laparotomic cholecystectomy
15759555|NCT04780724|Other|Hypoxic gas mixture|Gas mixture of 12% O2 and 88% N2 for five minutes.
15759556|NCT04780724|Other|Hypercapnic and hypoxic gas mixture|Gas mixture of 12% O2, 5% CO2, and 88% N2 for five minutes.
15759557|NCT04780724|Other|SpO2 measurement|Two SpO2 measuring devices are active simultaneously during measurement.
15759558|NCT04780698|Diagnostic Test|SARS-CoV-2 RT-PCR Assay for Detection of COVID-19 Infection|COVID-19 infection and antibody testing
15759523|NCT04781049|Procedure|Trans-Perineal Laser Ablation of Prostate|"TPLA treatment will be performed using the EchoLaser EVO system (Elesta SpA - Calenzano, FI, Italy). EchoLaser EVO consists of four echolasers, a multi-source laser system with a wavelength of 1064nm and Echolaser Smart Interface (ESI), a treatment planning device for safely inserting introductor needles and optical fibers into prostate tissue. EchoLaser therapy is a micro-invasive percutaneous procedure that uses laser light transmitted through applicators (optical fibers) for a few minutes, causing a heating of the affected tissue to its irreversible damage in situ, without the need to remove it. EchoLaser therapy, through flat-tip fibers, produces an ellipsoidal clotting area (area where the tissue has irreversible damage). EchoLaser therapy will be performed under ultrasound guidance."
15759524|NCT04781049|Procedure|Trans-Urethral Resection of Prostate|TURP is the gold standard for the treatment of benign prostatic obstruction. It will be performed by using a bipolar energy resectoscope. The procedure will be carried out with patient in a lithotomic position.
15759525|NCT04781036|Drug|4%Chlorhexidine|4%Chlorhexidine was given to participants with foot odor for 1 month.
15759526|NCT04781023|Device|Colpofix|Intravaginal gel with carboxymtheyl beta-glucan and polycabophil. Posology: 1 application / day x 20 days, rest 10. Repeat 20 x 3 cycles
15759527|NCT04781010|Device|MRI|MRI pattern in children with Leukodystrophy
15759528|NCT04780997|Other|Virtual Reality|Microsoft Xbox Kinect® was used for virtual reality exercises
15759529|NCT04780984|Drug|Tiotropium bromide inhalation solution|Tiotropium bromide inhalation solution
15759530|NCT04780984|Drug|Placebo|Placebo comparator
15759531|NCT04780971|Diagnostic Test|post-PCI Pd/Pa|After angiographically successful CTO PCI, intra-coronary physiologic assessment (RFR, FFR, CFR and IMR) of the CTO vessel will be performed directly. A staged procedure including several measurements is planned at 4 ± 2 weeks after the index procedure. These measurements consists of the same intra-coronary physiologic assessments at index procedure and OCT imaging of the stented segment in the CTO target vessel.
15759532|NCT04780958|Other|Serum retinol and RBP levels were determined by enzyme-linked immunosorbent assay.|Umbilical cord blood was drawn at birth in all babies included in the study by experienced individuals using a vacutainer. Approximately 6 ml of venous blood was also drawn from the antecubital region of the mothers immediately after the birth in a biochemistry tube.In the serum samples, the retinol levels were analyzed using ELISA kits from the Bioassay Technology Laboratory ( E1548 Hu Jiaxing, Zhejiang, China), RBP levels were analyzed using ELISA kits of Elabscience (E-EL-H1581 Texas USA) following the standard protocol suggested by the manufacturer at the Dynex automated ELISA reading device (Dynex Technologies Headquarters, Chantilly, USA)
15759533|NCT04780945|Diagnostic Test|Functional RAD51 assay|ex vivo functional assay (RAD51 assay also known as Repair Capacity (RECAP) assay ) to test homologous recombination deficiencie (HRD) in viable tumor tissue
15759534|NCT04780945|Drug|Olaparib Oral Product|300 mg bid
15759535|NCT04780932|Drug|Macitentan 10mg|Macitentan 10 mg will be initiated at Day 8 (+/- 3 days) until week 42 (+/- week). The recommended dose is 10 mg once daily by oral administration
15759536|NCT04780932|Drug|Placebo|Placebo 10 mg will be initiated at Day 8 (+/- 3 days) until week 42 (+/- week). The recommended dose is 10 mg once daily by oral administration
15759537|NCT04780919|Device|BTL-6000 FSWT|Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300.
15759538|NCT04780919|Device|BTL-6000 FSWT with sham applicator|Intensity 0,12 mJ/mm2, frequency 10 Hz, total number of shocks 1300 - applied with modified applicator which does not allow wave transmission.
15759539|NCT04780906|Other|Wrist taping|Wrist taping as used as standard in CrossFit practice
15759540|NCT04780893|Device|Modius Sleep|The device utilizes a technology called vestibular nerve stimulation (VeNS). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day.
15759541|NCT04780867|Behavioral|Delayed vaccination|First and second hepatitis B vaccinations will be delayed by 1 month in the interventional group to establish whether changes in psychosocial and lifestyle factors during training impact immune health.
15759542|NCT04780854|Drug|Metformin|Participants in the intervention group will be administered metformin tablets 2 gm daily during the chemotherapy treatment duration
15759543|NCT04780854|Drug|Placebo|Participants in the placebo group will be administered metformin free tablet as placebo twice daily
15759544|NCT04780841|Drug|RDX013|RDX013 is an experimental drug that is a potassium secretagogue
15759545|NCT04780841|Drug|Placebo|Placebo treatment that looks identical to experimental treatment
15759546|NCT04780815|Other|myBluTM Formulation 1|1-2 puffs of each 3-5 seconds duration taken from myBluTM with Formulation 1, with inhalation of the vapour into the lungs
15759547|NCT04780815|Other|myBluTM Formulation 2|1-2 puffs of each 3-5 seconds duration taken from myBluTM with Formulation 2, with inhalation of the vapour into the lungs
15759548|NCT04780802|Procedure|The balloon catheter is placed at the various arterial feeders of the tumor|use of a balloon catheter for providing balloon occlusion, in addition to the standard microcatheter for drug delivery, both catheters are to be placed in parallel through a single guide catheter. Only one arterial puncture wound is involved. The inflated balloon provides temporary occlusion of all arterial tumor feeders except for the one which is selectively catheterized with a microcatheter for delivery of the therapeutic agent. The therapeutic agent consists of Lipiodol mixed with a chemotherapeutic drug, it is delivered through the microcatheter under fluoroscopic control.
15759549|NCT04780789|Procedure|Transarterial Chemoembolization|A contrast agent (Xenetix350, Guerbet, France) was applied under local anaesthesia via the common femoral artery using a 5F sheath. Selective catheterization of the coeliac trunk and other arteries supplying the liver was then performed under fluoroscopic control. A pathological vascularization pattern was identified and chemoembolization material consisting of DC beads (BTG International Ltd) was injected by the treating angiographist using micro instrumentation. Follow-up CT or MRI was performed after 1-3 TACE sessions according to the extent of the lesion, 3 weeks following the last procedure. Patients with completed treatments were scheduled for an imaging follow-up every 3 months, allowing evaluation of the effect of treatment. In case of a positive response to the treatment another session of TACE was indicated. Chemoembolization sessions were performed as inpatient procedures with the mean hospitalization time of 4 days.
15759559|NCT04780685|Biological|hMSC|IV administration
15759560|NCT04780672|Drug|Molixan|The investigational drug in this study is Molixan in the dosage form of 30 mg/ml solution for intravenous and intramuscular injection. Against the background of standard therapy: Molixan® at a dose of 3.0 mg/kg per day is administered once intravenously (stream injection) with 0.9% sodium chloride solution at a volume ratio of 1:1 for 10 days.
15759561|NCT04780672|Drug|Placebo|Placebo will be used as a comparator drug and will be an analogue of the investigational drug without active substance. Against the background of standard therapy: Placebo at a dose of 3.0 mg/kg per day is administered once intravenously (stream injection) with 0.9% sodium chloride solution at a volume ratio of 1:1 for 10 days.
15759562|NCT04780659|Biological|Comirnaty (COVID-19, mRNA vaccine)|Comirnaty will be administered two times, one at Day 0 and the second dose at Day 21.
15759563|NCT04780646|Behavioral|Nature therapy in urban nature|Nature therapy means visits in nature, actively perceiving the flora and fauna
15759564|NCT04780646|Behavioral|City Walk|City Walk means walking through urban surroundings (houses, streets, concrete..) with as little as possible contact to nature
15759565|NCT04780633|Behavioral|Precede-Proceed based Training Program on Genital Hygiene Behaviors|A Training Program for Genital Hygiene Behaviors prepared in line with the Precede-Proceed model was presented to the women in the experimental group. The trainings started one week after the pre-test data were collected and were conducted in a total of 5 sessions, each lasting an average of 40 minutes, once a week. At the end of the five-week training, a post-test was applied. In order to determine the behavior changes of the women in the experimental group, a follow-up test was applied 4 weeks after the training ended. At the end of the training, women were given a training booklet prepared by the researcher.
15759566|NCT04780620|Other|Parent Intervention Group|Parents will be involved in 8 weekly sessions.
15759567|NCT04780607|Device|mitral valve repair|different repair techniques to construct rheumatic mitral valve lesion
15759568|NCT04780594|Procedure|The study evaluates all surgical patients operated, both elective scheduled and emergent cases|Administrative database was automatically collected. That included demographic, clinical antecedents, surgical team and surgical procedure, primary and secondary diagnoses and principal and secondary surgical procedures. A case-mix grouping system administrative automatic recorded based on the ICD-10-AM International Classification of Diseases. According to the Diagnoses-related Groups (DRG's). the Severity of Illness Index assigns to each patient an overall severity score (from 1 to 4) and mortality risk score (from 1 to 4)
15759569|NCT04780581|Drug|Dexamethasone|6 mg/24h - 10 days
15759570|NCT04780581|Drug|Methylprednisolone|250 mg/ 24h - 3 days
15759571|NCT04780568|Drug|Osimertinib|Given PO
15759572|NCT04780568|Drug|Tegavivint|Given IV
15759573|NCT04780542|Behavioral|Yo Puedo Sentirme Bien- Clinician-Guided version|Internet delivered Cognitive Behavioral Therapy- Guided version
15759574|NCT04780542|Behavioral|Yo Puedo Sentirme Bien- Self-Guided version|Internet delivered Cognitive Behavioral Therapy- Self-Guided version
15759575|NCT04780542|Behavioral|Treatment as usual|Waitlist until appointment and then treatment as usually provided by student clinic
15759576|NCT04780529|Biological|gucy2c cart cells|Patients with advanced malignant gastrointestinal tumors were injected with CART cells
15759577|NCT04780503|Diagnostic Test|Rapid Shallow Breathing Index|The RSBI is defined as the ratio of respiratory frequency to tidal volume.
15759578|NCT04780490|Other|liberal fluid management|10 ml/ kg/ hr Ringer's lactate solution
15759579|NCT04780490|Other|restrictive fluid management|2 ml/ kg/ hr Ringer's lactate solution with 2 mcg / kg / hr norepinephrine infusion
15759580|NCT04780477|Dietary Supplement|Experimental: High Fiber Diet (HFD)|Experimental: High Fiber Diet (HFD) pre-portioned entrées for two meals/d in mos. 1-3, and one meal/d in mos. 4-6. Participants continue on their respective diets in mos. 7-12 but assume responsibility for food preparation. The HLD will contain approximately 250g of legumes per day (~1 ½ cups cooked) in months 1-3 provided in two pre-portioned single serving entrées (i.e. ~125g each). A study nutritionist will provide in-person and written guidance for including sides that are nutritionally balanced with energy intake to lose 1-2 lbs. /wk.
15759581|NCT04780477|Dietary Supplement|Healthy American Diet|Healthy American Diet pre-portioned meal replacement entrées with legumes replaced by lean chicken/meat. A study nutritionist will provide in-person and written guidance for including sides that are nutritionally balanced with energy intake to lose 1-2 lbs. /wk.
15759582|NCT04780464|Drug|Doxorubicin|60 to 75 mg/m² intravenous, every 3 weeks for max 6 cycles until PD
15759583|NCT04780464|Drug|Doxorubicin|12 mg/m2 intravenous weekly for a maximum of 450 mg/m2 until PD
15759584|NCT04780464|Drug|Cyclophosphamide Oral Product|100 mg BD on day 1 to day 7 of each 14 day cycle until PD
15759585|NCT04780464|Drug|Prednisolone|10-20 mg on day 1 to day 7 of each 14 day cycle until PD
15759586|NCT04780451|Dietary Supplement|Omega-3 supplementation in recreational runners|Male recreational runners participated in 12 weeks of endurance training combined with omega-3 fatty acids supplementation. Before starting and at the end of the 12-week cycle, the runners performed an increasing intensity treadmill test where oxygen uptake and VO2 peak were assessed.
15759587|NCT04780438|Drug|Dapagliflozin|Patients rendomized in this arm will receive dapagliflozin at a target dose of 10mg once daily.
15759588|NCT04780438|Drug|Placebo|Patients rendomized in this arm will receive placebo.
15759589|NCT04780425|Behavioral|DESMOND|as previously described
15759590|NCT04780425|Other|usual care|usual care as per standard treatment guidelines of Ghana unstructured/adhoc diabetes education during clinic visits
15759591|NCT04780412|Drug|Misoprostol|Vaginal Misoprostol tablets in a dose of 50 microgram given 90-120 minutes before an elective caesarian section.
15759592|NCT04780412|Drug|Placebo|Vaginal placebo pills given 90-120 minutes before an elective caesarian section.
15759593|NCT04780399|Drug|Yangxue Qingnao pills|72 subjects in the Yangxue Qingnao pills group take 7.5g of Yangxue Qingnao pills each time, twice a day, 0.5 hours after breakfast and dinner, taking with warm water.
15759594|NCT04780399|Drug|Yangxue Qingnao pills|72 subjects in the Yangxue Qingnao pills group take 5g of Yangxue Qingnao pills and 2.5g placebo identified to Yangxue Qingnao pills each time, twice a day, 0.5 hours after breakfast and dinner, taking with warm water.
15759595|NCT04780399|Drug|Placebo|72 subjects in the placebo group take 7.5g placebo identified to Yangxue Qingnao pills each time, twice a day, 0.5 hours after breakfast and dinner, taking with warm water.
15759597|NCT04780386|Drug|NVP-1805-R1and NVP-1805-R2|orally, once daily on Period 1 or Period 3 (or Period 2 and Period 4)
15759598|NCT04780373|Other|data collection|clinical data collection
15759599|NCT04780360|Procedure|Cayanoacrylate tissue adhesives|Cyanoacrylates are a family of strong fast-acting adhesives with industrial, medical, and household uses. They are various esters of cyanoacrylic acid. The acryl groups in the resin rapidly polymerize in the presence of water to form long, strong chains
15759600|NCT04780360|Procedure|Silk suture|Non Absorbalble suture materiel used to fixed the edges of the incision in place until healing
15759601|NCT04780347|Drug|Albumin-bound paclitaxel plus capecitabine|Albumin-bound paclitaxel plus capecitabine: Albumin-bound paclitaxel 260mg/m2, IV , D1, q3w； capecitabine 1000 mg/m2, PO，bid, D1-14,q3w.
15759602|NCT04780347|Drug|capecitabine|capecitabine: capecitabine 1000 mg/m2, PO，bid, D1-14,q3w.
15759603|NCT04780334|Diagnostic Test|COVID-19 RT-PCR|Nasopharyngeal swabs for COVID-19 RT-PCR
15759604|NCT04780334|Diagnostic Test|Biosensor|Portable and Connected Biosensor viral
15759605|NCT04780321|Biological|Recombinant Human Anti-SARS-CoV-2 Monoclonal Antibody(25mg/kg;50mg/kg;100mg/kg)|use dose 1/2/3 60 patients receipt JS016 intravenous infusion on day 1
15759606|NCT04780321|Drug|Placebo|30 patients receipt placebo intravenous infusion on day 1
15759607|NCT04780308|Procedure|Pediatric Garthland Type 3 supracondylar humeral fractures fixed by K-wires|The effects of the different types of K-wire configuration on Pediatric Gartland Type 3 supracondylar humeral fractures were evaluated. Pediatric Gartland Type 3 supracondylar humeral fractures operated under general anesthesia with open or closed reduction. After reduction checked by fluoroscopy K-wires applied in different configurations.
15759608|NCT04780282|Other|Scapular Stabilization Group|Participants will apply the 5 exercises given.
15759609|NCT04780269|Device|Induction of labor with Foley catheter|A Foley catheter will be introduced transcervically in women allocated in this group, with the aid of a vaginal speculum after cervical cleaning with an aseptic solution. The balloon will be inflated with 60 mL of sterile 0.9%% sodium chloride (NaCl) after insertion past the internal os. The external end of the catheter is taped to the inner thigh without applying any traction or tension.
15759610|NCT04780269|Drug|Induction of labor with PGE2|PGE2 (1mg) will be inserted into the posterior vaginal fornix. Women will be assigned one hour of bed rest while continuously monitored by cardiotocography.
15759611|NCT04780256|Procedure|Endoscopic resection|"The endoscopic resection is the procedure that allows to remove cancerous or precancerous conditions of digestive tract. Endoscopic resection can be preformed by several techniques:
~Endoscopic mucosal resection (EMR): it allows to remove mucosal lesions
~Endoscopic submucosal dissection: it allows to remove mucosal lesions that involved submucosal layer and large lesions
~Full-thickness resection: it allows to remove infiltrating lesions by the resection of a little piece of the entire gastrointestinal wall"
15759612|NCT04780243|Other|counseling|Mothers presented to infant immunization units are going to be counseled for family planning services and if decide to take any method, they will be linked to family planning services
15759613|NCT04780230|Device|tDCS active|An anodal high-definition tDCS of 2 mA lasting for 20 minutes will be delivered to the orofacial area of the primary motor cortex (SM1) during speech therapy.
15759614|NCT04780230|Device|tDCS sham|An anodal high-definition tDCS of 2 mA lasting for 30 seconds will be delivered to the orofacial area of the primary motor cortex (SM1) during speech therapy.
15759615|NCT04780217|Biological|T3011|T3011 will be administered in a 10 mL solution as an IV infusion
15759616|NCT04780217|Combination Product|T3011 + pembrolizumab|T3011 will be administered in a 10 mL solution as an IV infusion followed by administration of IV pembrolizumab
15759617|NCT04780204|Drug|Treatment|Tenofovir Alafenamide 25 mg oral once daily
15759618|NCT04780204|Drug|Observation of Hepatitis B|Best Supportive care
15759619|NCT04780191|Device|MyoRegulator®|Trans-spinal DC stimulation paired with peripheral DC stimulation
15759620|NCT04780178|Behavioral|Telephone Acceptance and Commitment Therapy Intervention for Caregivers of Adults with Alzheimer's Disease and Related Dementias|A telephone-based acceptance and commitment therapy for caregivers
15759621|NCT04780165|Device|Blephademodex|During the first 28 days of the trial, subjects will use one Blephademodex® eyelid hygiene wipe every evening per eye to clean the eyelids of both their eyes. At the start of the second period the Investigator will assess based on the GDS if the condition is resolved and manage accordingly: subjects will either continue with this regime if GDS is unchanged (further treatment phase) or revert to Blephaclean wipes every evening instead (maintenance phase), again to clean the eyelids of both their eyes.
15759622|NCT04780152|Device|Transcranial Direct Current Stimulation|Participants receive 10 consecutive sessions followed by 1 session per week 10 weeks of tDCS (30 minutes and 2 mA). Anodal stimulation will be applied on F3 according to the intentional 10/20 system, and the cathode will be applied on the contra lateral position (F4).
15759623|NCT04780152|Device|Placebo-simulation of transcranial direct current stimulation|Participants receive 10 consecutive sessions followed by 1 session per week 10 weeks of placebo (30 minutes of placebo-simulation tDCS). Placebo will be administered using the same stimulation parameters and the active treatment position of the electrodes, but current wil be aborted 30 seconds after the ascending slope has begun.
15759624|NCT04780152|Drug|Fluoxetine Tablets|Every patient will receive 10 mg of fluoxetine daily the first 2 two weeks, followed by 20 mg daily.
15759625|NCT04780139|Diagnostic Test|Ultrasonographic Evaluation of Internal Jugular Vein Cross Sectional Area|Measuring the internal jugular vein cross section area and relate this to the incidence of hypotension after spinal anesthesia.
15759626|NCT04780126|Other|Sarcopenia diagnosis|History, physical, laboratory and ultrasound parameters to diagnose sarcopenia
15759627|NCT04780074|Dietary Supplement|Single dose intervention with Standard product (SP)|2 capsules - 200 mg total CoQ10
15759628|NCT04780074|Dietary Supplement|Single dose intervention with Investigational product (IP1)|2 softgels - 200 mg total CoQ10
15759629|NCT04780074|Dietary Supplement|Single dose intervention with Investigational product (IP2)|2 softgels - 200 mg total CoQ10
15759630|NCT04780074|Dietary Supplement|Single dose intervention with Investigational product (IP3)|2 softgels - 200 mg total CoQ10
15759631|NCT04780074|Dietary Supplement|Single dose intervention with Investigational product (IP4)|2 capsules - 200 mg total CoQ10
15759742|NCT04779177|Drug|Lumateperone 28 mg|Lumateperone 28 mg, oral administration
15759632|NCT04780061|Drug|Vitamin D3 50,000 IU|This is a loading dose of Vitamin D. Vitamin D (cholecalciferol [vitamin D3]) is a fat-soluble vitamin that is synthesized following ultraviolet radiation to the skin, naturally occurs in a few dietary sources and is available as a dietary supplement.
15759633|NCT04780061|Dietary Supplement|Vitamin C/Zinc|This is a combination of Vitamin C and Zinc. Vitamin C (ascorbic acid, ascorbate) is a water-soluble vitamin that naturally occurs in many foods and is sold as a dietary supplement. It is required for the functioning of several enzymes and is important for the immune system. Zinc is one of the most abundant essential trace elements in the human body and is required for the function of several hundred enzymes and transcription factors.
15759634|NCT04780061|Dietary Supplement|Vitamin K2/D|This is a combination of Vitamin K2 (menaquinone-7) and vitamin D. Vitamin K (menaquinone-7 [vitamin K2]) is a fat-soluble vitamin found in foods and sold as a dietary supplement. Vitamin K plays a large role in synthesizing coagulation factors in the blood, and vitamin K deficiency has been associated with uncontrolled bleeding. Vitamin K1 (phylloquinone) is an alternate form of vitamin K found in foods and supplements; however, vitamin K2 has a better absorption profile50 and additionally plays a role in bone metabolism controlling the binding of calcium, especially in older adults, where it attenuates the rate of bone loss
15759635|NCT04780061|Other|Microcrystalline Cellulose Capsule|Placebo equivalent of Vitamin C/Zinc and Vitamin D3.
15759636|NCT04780061|Other|Medium Chain Triglyceride Oil|Placebo equivalent of Vitamin K2/D
15759637|NCT04780035|Biological|EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19)|"The EpiVacCorona vaccine is intended to prevent COVID-19. The vaccine relies on chemically synthesized peptide antigens of SARS-CoV-2 proteins conjugated to a carrier protein and adsorbed on an aluminum-containing adjuvant (aluminum hydroxide).
~The vaccine induces the specific immunity against the SARS-CoV-2 coronavirus following two intramuscular injections spaced 21 to 28 days apart.
~The EpiVacCorona vaccine contributes to the development of protective immunity against SARS-CoV-2 coronavirus following two intramuscular administrations given 21 to 28 days apart."
15759638|NCT04780035|Other|Placebo (sodium chloride, a 0.9% solution for the preparation of dosage forms for injections)|The use of placebo: intramuscularly twice, given 21 to 28 days apart at a dose of 0.5 ml
15759639|NCT04780022|Other|Clinical events at last follow-up|Clinical events (stroke, transient ischemic attack, peripheral embolism, deep venous thrombosis, atrial fibrillation, myocardial infarction, bleeding episode, death) at last follow-up
15759640|NCT04779996|Diagnostic Test|Laboratory Samples|"After full vaccination with a Covid 19 vaccine, the following laboratory samples will be taken one time only, two weeks after full dose vaccination: i. Serologic rapid test (IgG, IgM) ii. Serum quantitative immunoglobulin levels iii. CD4 level iv. CD8 level
~Laboratory samples will be taken at Hospital Auxilio Mutuo Laboratorio Clínico. Likewise, the Immuno Reference Lab might be used as an alternative.
~Since monoclonal antibody therapy can induce hypogammaglobulinemia, we will measure gammaglobulin levels to correlate with antibody response to vaccine. Similarly, we will evaluate the CD4 and CD8 counts."
15759641|NCT04779970|Other|Cessation of ongoing treatment|Cessation of ongoing treatment
15759643|NCT04779944|Other|other|questionnaire
15759644|NCT04779931|Behavioral|Convoy-Pal|12 week mobile self-management intervention with palliative care resources.
15759645|NCT04779918|Device|OviTex Reinforced Tissue Matrix|All study subjects will receive OviTex. All OviTex Reinforced Tissue Matrices are intended for use as a surgical mesh to reinforce or repair soft tissue where weakness exists.
15759646|NCT04779905|Diagnostic Test|urinary albumbin/creatinine ratio|detection of microalbuminuria in nafld patients
15759647|NCT04779892|Drug|Infliximab|100mg/vial
15759648|NCT04779879|Biological|Sotrovimab (Gen1)|Participants will be randomized to receive an IV infusion of Sotrovimab Gen 1 material
15759649|NCT04779879|Biological|Sotrovimab (Gen2)|Participants will be randomized to receive Sotrovimab Gen2 material by IV infusion or by IM injection
15759650|NCT04779866|Behavioral|Self-Administered Hypnosis|Participants randomized to the self-administered hypnosis group will receive five audio-recordings of self-administered hypnosis, specifically targeting sleep improvement, which they will use for daily home practice.
15759651|NCT04779866|Behavioral|Self-Administered White Noise Hypnosis|Participants randomized to the white noise hypnosis control will receive the same information and contact with the therapist, but will be provided with audio recordings that contain white noise as a sham hypnosis condition. These recordings include instructions and the use of white noise as a hypnotic induction.
15759652|NCT04779853|Diagnostic Test|Blood samples for pertussis antibody testing|Blood samples will be sent to the laboratories of the National Centers of Expertise within 24-48 hours of blood collection. The samples will be transferred to the reference laboratory of SPCSEEM in Almaty, Kazakhstan. Serum samples will be stored in the reference laboratory at a temperature of -20 C.
15759653|NCT04779840|Other|anemia assessment|evaluation of anemia status
15759654|NCT04779827|Behavioral|Online Social Network and Collective Intelligence Intervention|The online network intervention aims to use different configurations of online social networks to optimize the impacts of collective intelligence process to improve individuals' understanding, beliefs, and behavioral choices regarding a variety of health behaviors. Participants will be put into different online networks and respond to health questions while receiving feedback from their network members.
15759655|NCT04779827|Behavioral|Independent Control|Independent control aims to test the baseline of population understanding of health behaviors and choices. Participants will respond to health questions independently without getting any feedback from others.
15759656|NCT04779801|Behavioral|Attachment-Based Family Therapy|16 weeks of Attachment-Based Family Therapy treatment.
15759657|NCT04779788|Device|I-125 seeds loaded stent (self-expanded metal stent with I-125 seeds, Micro-Tech, Nanjing, China)|An I-125 seeds loaded stent consisted of two overlapped parts: an inner normal bare stent and an outer seeds-loaded stent
15759658|NCT04779788|Device|Normal stent (self-expanded metal stent without I-125 seeds, Micro-Tech, Nanjing, China)|Bare self-expanded metal stent
15759659|NCT04779762|Other|Crohn's disease exclusion diet (CDED)|Dietary therapy for Crohn's disease
15759660|NCT04779762|Drug|Ustekinumab Injection [Stelara]|Drug for Crohn's disease
15759661|NCT04779749|Other|Data extraction from medical files|Data extraction from medical files
15759662|NCT04779736|Behavioral|A set of implementation strategies to reduce sexual stigma|The intervention will be finalized based on formative interviews and consultation with an advisory board. It is likely to include an educational mHealth component followed by an in-person workshop for skills development, then supportive coaching components (i.e., coaching calls and an optional email listserve) to encourage and respond to the implementation of recommended practices.
15759663|NCT04779723|Procedure|Comparison of two Techniques of bariatric surgery|We compared the 30 days outcomes in patients who underwent LSG procedure with those who underwent LRYGB
15759664|NCT04779710|Other|Staff Survey|A mixed mode survey design comprising of a self-administered electronic survey with a secondary option of a postal survey. The survey population was Speech and Language Therapy (SLT) Clinical Leads for Acute Stroke in Hyper/Acute Hospital Stroke Units in England and Wales. The sample frame was Routinely Admitting, and Non-Routinely Admitting Acute Stroke Hospital Teams registered on the Sentinel Stroke National Audit Programme (SSNAP) register. One hundred and sixty-six hospital teams were included after exclusions. Survey participants were asked to respond about assessment and management of dysphagia and other clinical processes during the first seven days of a person's admission to hospital following a stroke. Respondents were asked to respond about practice on behalf of the Stroke Unit rather than as an individual practitioner.
15759665|NCT04779697|Drug|GLP-1 analogue - semaglutide|GLP-1 analogue - semaglutide - administered once weekly for a total of 12 weeks
15759666|NCT04779697|Other|Placebo|Placebo - administered once weekly for a total of 12 weeks
15759667|NCT04779684|Other|Advance care planning by proxy for health care proxies of people without medical decision making capacity|Two discussions between a trained health professional and a health care proxy of an RACF resident who no longer has decision making capacity. First discussion focuses on life story, values, previous experiences with medical treatments, illness and death. Second discussion also includes treating physician and focuses on establishing general goals of care and medical orders in case of emergency.
15759668|NCT04779671|Behavioral|VR cognitive training|"All participants will receive trainings for 60 minutes per day, two days per week for 16 sessions.
~They will receive one immersive leisure-based VR cognitive training for 30 minutes. VR cognitive training receives four gardening activities.
~The cognitive elements including attention, working memory, processing speed, and executive function incorporated training."
15759669|NCT04779671|Behavioral|Traditional cognitive training|"All participants will receive trainings for 60 minutes per day, two days per week for 16 sessions.
~The control group is performing traditional cognitive training program."
15759670|NCT04779645|Drug|REMD-477|12-Week, once weekly subcutaneous injection with 70mg REMD-477
15759671|NCT04779645|Drug|Placebo|12-Week, once weekly subcutaneous injection with placebo
15759672|NCT04779632|Dietary Supplement|Experimental: Fish Oil|Participants are provided with fish oil capsules and asked to take 4 capsules of 1000 mg twice a day (in total 5.2 mg/day of long-chain n-3 fatty acids hereof 2400 mg of eicosapentaenoic acid and 1600 mg of docosahexaenoic acid) for 4 weeks.
15759673|NCT04779632|Dietary Supplement|Comparator: Safflower Oil|Participants are provided with fish oil capsules and asked to take 4 capsules of 500 mg twice a day (containing ~ 3000 mg of linoleic acid) for 4 weeks.
15759674|NCT04779619|Other|Online self-report questionnaire completion|After reading the PIS and completing the consent page on Qualtrics participants will then be presented with the demographic, PHQ-9, GAD-7 and BSL-23 questionnaires which will be used to determine later allocation of their data to one of the three group. They will then be presented with the PERCI, FFMQ-15 and DERS.
15759675|NCT04779606|Drug|Ocular gel|3 drops instilled in the right eye
15759676|NCT04779593|Other|Clinical examination|Clinical data will be recorded (general clinical examination, height, weight, blood pressure,heart beat, alcohol and tobacco consumption, antecedent) as well as concurrent medication at each follow-up visit.
15759677|NCT04779593|Other|SF36 questionnaire|"At D0, M12 and M24. This 36 item patient reported survey of patient's health is the most commonly used and validated health survey instrument for appraising quality of life.
~Items are grouped in 8 scaled scores exploring multiple dimension of global health (vitality, physical functioning, bodily pain, general health, perceptions, physical role functioning, emotional role functioning, social role functioning, mental health).
~Scoring will be performed as recommended by the SF-36 instruction manual to create the eight scale scores. Furthermore, these subscales sum to obtain the total SF-36 score and will be summarized into two composite scores (physical and mental quality of life)."
15759678|NCT04779593|Other|AIMS2_SF questionnaire|At D0, M12 and M24. The Arthritis Impact Measurement Scales 2 Short Form (AIMS2-SF) is a specific tool to measure changes in global health, pain, mobility and social function in patients with arthritis. It was described in 1992 in patients with rheumatoid arthritis and osteoarthritis and include 26 items that are summarized in scales according to a predefined scoring system: mobility, physical activity (walking, bending, lifting), dexterity, household activity (managing money and medications, housekeeping), social activities, activities of daily living, pain, depression, and anxiety. The French translation has been validated and this questionnaires has been widely used in the rheumatology field to assess quality of life of patients with arthritis. Because HFE related arthropathy is very similar to osteoarthritis this questionnaire is ought to be adequate in this setting.
15759679|NCT04779593|Other|WOMAC questionnaire|At D0, M12 and M24. The Western Ontario and McMaster Universities Arthritis Index (WOMAC) is a widely used questionnaires specifically assessing lower limb (hips and knee) osteoarthritis. It measures five items for pain, two for stiffness and 17 for functional limitation and had been translated in French.
15759680|NCT04779593|Other|EQ-5D-5L questionnaire|At D0, M12 and M24. The EQ-5D is a standardized instrument which evaluates the generic quality of life (http://www.euroqol.org/). It is a preference-based health-related quality of life measure with one question for each of the five dimensions that include mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The answers given to EQ-5D permit to find 243 health states that can be converted into utility score anchored at 0 for death and 1 for perfect health. EQ-5D is an instrument developed in Europe, widely used in cost-utility analysis. It has been validated in a representative sample of French population.
15759681|NCT04779593|Biological|Blood Sample Complete blood count|Blood Sample Complete blood count at D0, M6, M12, M18 and M24/end follow-up visit
15759906|NCT04777747|Other|viral infection|a child is infected by virus only
15759682|NCT04779593|Biological|Blood Sample Iron panel|Blood Sample Iron panel (serum ferritin, serum iron and serum transferrin to determine transferrin saturation according to randomization group (at M6, M12 and M18) at D0, M6, M12, M18 and M24/end follow-up visit and at each bloodletting.
15759683|NCT04779593|Biological|Blood Sample Fasting Glucose|Blood Sample Fasting Glucose at D0 and M24/end follow-up visit
15759684|NCT04779593|Biological|Blood sample lipid panel|Blood sample lipid panel (total cholesterol, triglycerides, HDL, LDL) at D0 and M24/end follow-up visit
15759685|NCT04779593|Biological|Blood sample liver panel|Blood sample liver panel (total bilirubin, Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Gamma-Glutamyl Transferase) at D0 and M24/end follow-up visit
15759686|NCT04779593|Biological|Blood sample C reactive protein|Blood sample C reactive protein at D0 and M24/end follow-up visit
15759687|NCT04779593|Procedure|Bloodletting - control group|Patients treated with bloodletting according to current guidelines (ferritin alone). Patient will undergo bloodletting with a goal of maintaining a serum ferritin equal or lower than 50 g/L according to current clinical practice guidelines (French and European).A first bloodletting will be performed at inclusion with the same volume as usually performed by the patients.Results of the biological test performed at this visit will guide the time schedule and volume of the next bloodletting according to randomization group. Time schedule and volume of bloodletting will be adjusted to biological results after each follow-up visit.
15759688|NCT04779593|Biological|BioBank|Blood sample will be collected for BioBank at D0, M12 and M24.
15759689|NCT04779593|Other|Medico-economical|Medico-economic data will be collected at each follow up visit.
15759690|NCT04779593|Procedure|Bloodletting - experimental group|"Patients treated with bloodletting according to transferrin saturation and serum ferritin. Patients will undergo bloodletting with a goal of maintaining a serum transferrin saturation equal or lower than 50 % and a serum ferritin lower than the upper limit of the normal range (300 g/L for men and 200 g/L for women).A first bloodletting will be performed at inclusion with the same volume as usually performed by the patients.Results of the biological test performed at this visit will guide the time schedule and volume of the next bloodletting according to randomization group. Time schedule and volume of bloodletting will be adjusted to biological results after each follow-up visit."
15759691|NCT04779580|Procedure|Lateral Cutaneous Nerve Of The Thigh Nerve Block Using Local Anaesthetic|Currently accepted aseptic conditions will be met. The lateral cutaneous nerve of the thigh will be identified on ultrasound (Sonosite X-Porte) and 5mL of 1% lidocaine will be administered around the nerve using a 50mm Stimuplex needle. The area of anaesthesia will be demarcated using ice.
15759692|NCT04779580|Procedure|Subcostal Nerve Block Using Local Anaesthetic|Currently accepted aseptic conditions will be met. The subcostal nerve will be identified on ultrasound (Sonosite X-Porte) and 5mL of 1% lidocaine will be administered around the nerve using a 50mm Stimuplex needle. The area of anaesthesia will be demarcated using ice.
15759693|NCT04779567|Drug|Acetaminophen|Acetaminophen 1 gr iv 4 times a day
15759694|NCT04779567|Drug|Placebo|100 ml saline 0.9% iv 4 times a day
15759695|NCT04779554|Drug|Mitomycin C, flat dose 40 mg|Mitomycin C will be delivered as heated intraperitoneal chemotherapy (HIPEC) in two flat doses. Dose 1 will be 30mg at minute 0 and dose 2 will be 10 mg at minute 60.
15759696|NCT04779554|Drug|Mitomycin C, weight-based dose 12.5 mg/m2|Mitomycin C will be delivered as heated intraperitoneal chemotherapy (HIPEC) in two weight-based doses of 9 mg/m2 at minute 0 and 3 mg/m2 at minute 60.
15759697|NCT04779541|Other|observation|observation of the mechanisms of acceptance or rejection of the vaccine
15759698|NCT04779528|Procedure|Fiberoptic intubation in supine position.|"Patients will be placed in supine position after the establishment of full vital signs monitoring and the insertion of an intravenous line.
~Under sedation via intravenous infusion of remifentanil plus topical anesthesia with 10 ml of Lidocaine 1% via a 3.7mm bronchoscope. After applying a standard monitoring and preparation of the nose by decongestant and local anesthesia. A loaded flexible scope (by an endotracheal tube ETT) will be introduced through the nostril to reach the carina, then the ETT will be pushed over the scope 3cm above the carina."
15759699|NCT04779528|Procedure|Fiberoptic intubation in lateral position.|"Patients will be placed in lateral position after the establishment of full vital signs monitoring and the insertion of an intravenous line.
~Under sedation via intravenous infusion of remifentanil plus topical anesthesia with 10 ml of Lidocaine 1% via a 3.7mm bronchoscope. After applying a standard monitoring and preparation of the nose by decongestant and local anesthesia. A loaded flexible scope (by an endotracheal tube ETT) will be introduced through the nostril to reach the carina, then the ETT will be pushed over the scope 3cm above the carina."
15759700|NCT04779515|Procedure|low-pressure pneumoperitoneum|insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 8 to 10 mm Hg
15759701|NCT04779515|Procedure|standard-pressure pneumoperitoneum|insufflation of the abdomen for creation of pneumoperitoneum, pressure set points between 12 to 14 mm Hg
15759702|NCT04779502|Other|oregawash|mouthwash containing oregano essential oil
15759703|NCT04779502|Other|corsodyl|0.2% chlorhexidine mouthwash
15759704|NCT04779502|Other|placebo|distilled water
15759705|NCT04779489|Radiation|personalized ultrafractionated stereotactic ablative radiotherapy|next-generation stereotactic ablative radiotherapy to bladder and enlarged lymph nodes
15759706|NCT04779476|Other|Socket Dressing|Following dental extraction immediately, the socket will be dressed with one of the materials tested
15759707|NCT04779463|Diagnostic Test|Parasternal intercostal muscles thickness ultrasound indicies|"Parasternal intercostal muscles thickness ultrasound indicies includes:
~Parasternal Intercostals Thickness Fraction.
~Parasternal Intercostals Thickness at the End of Inspiration.
~Parasternal Intercostals thickness at the End of Expiration."
15759708|NCT04779450|Other|Kinesiotherapy protocol|The kinesiotherapy protocol is an exercise-based treatment designed to gain upper limb range of motion and muscle strengthening.
15759709|NCT04779450|Other|Usual orientations|Usual orientations for post-breast cancer women, such as skin care, return to activities, upper limb functionality, self-care, lymphedema, and physical activity practice.
15759737|NCT04779203|Device|Osseodensification Densah Bur|Implants placed with osseodensification surgical drilling compared to those placed with subtractive conventional drilling technique in a split-mouth design will result: 1) in the same insertion torque values and; 2) in the same implant stability quotient values when measured immediately after implant placement and after 1, 2, 3, 4, 5, 6, 7, 8, and 12 weeks.
15759710|NCT04779437|Behavioral|Imagery Cognitive Bias Modification|"The imagery cognitive bias modification intervention is derived from that developed via experimental psychopathology research (e.g. Holmes et al., 2009) and adapted for clinical applications in the context of depression (e.g. Blackwell & Holmes, 2010; Blackwell et al., 2015). The intervention is a series of training sessions in which participants listen to training scenarios consisting of descriptions of everyday situations, structured so that they start ambiguously but always end positively. Participants are instructed to imagine themselves in the situations described as the scenarios unfold. The training aims to train a bias to automatically imagine positive resolutions for ambiguous situations encountered in daily life.
~Participants will complete one introductory session of the training with the researcher present (in the outpatient center, or via videoconferencing software), then 8 sessions over two weeks completed from home via the study website."
15759711|NCT04779437|Behavioral|Cognitive Control Training|The cognitive control training is an adaptive Paced Auditory Serial Addition Task (PASAT), adapted from that applied in previous studies (e.g. Siegle et al., 2007; Hoorelbeke et al., 2015; Blackwell et al., 2018). Participants will complete one introductory session of the training with the researcher present (in the outpatient center, or via videoconferencing software), then 8 sessions over two weeks completed from home via the study website.
15759712|NCT04779424|Other|POCT|Capillary blood sample antibody point of care test
15759713|NCT04779411|Other|Weekly Food Frequency Questionnaire|A purpose designed 91-item questionnaire to measure frequency of consumption of a selection of L/Z containing foods over the prior 7 days.
15759714|NCT04779411|Other|Monthly Food Frequency Questionnaire|A purpose designed 95-item questionnaire completed at visit 1 to measure frequency of consumption of a selection of L/Z containing foods over the prior month.
15759715|NCT04779411|Other|24-Hour Diet Recall|the diet recall via the online Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24®) takes approximately 25 minutes to complete, and investigates food and beverages consumed in the prior 24-hours.
15759716|NCT04779411|Other|Electronic Device Use Questionnaire|1. The EDUQ: A 22-item questionnaire that takes 20 minutes to complete, and measures participant demographic information (weight, height, age, highest level of education, occupational status, post-code and country of residence), usual daily ED use from present up to 20 years ago, occupational influence to use, and differences to ED use between a weekend and weekday.
15759717|NCT04779411|Other|24-Hour Electronic Device Use Diary|Participants asked to record their electronic device use in hours and minutes over 24 hours.
15759718|NCT04779385|Procedure|PIPAC|"under general anaesthesia, a laparoscopy was performed using an open laparoscopic technique to prevent intestinal wounds, which would contraindicate the procedure. A 12 mmHg pneumoperitoneum was created, and to ensure the safety of the procedure the pressure of the pneumoperitoneum was maintained constant throughout the procedure. Two laparoscopic balloon trocars (of 11 and 12 mm) were used. A thorough exploration of the abdomen, Peritoneal Cancer Index assessment, images, peritoneal biopsies, and ascites cytology (in the case of ascites) were performed prior to administration of the chemotherapy aerosol.
~For carcinomas of gastric origin, Doxurubicin at a dose of 1.5 mg/m2 was administered in combination with Cisplatin 7.5 mg/m2 diluted in 40 and 150 mL of 0.9% sodium chloride, respectively. In the case of contraindication, Oxaliplatine at a dose of 92 mg/m2 in a 5% dextrose solution was recommended."
15759719|NCT04779372|Behavioral|smartphone-based dCBT-I from a Wechat applet|Participants will receive 6-week smartphone-based dCBT-I from a Wechat applet.
15759720|NCT04779372|Behavioral|sleep education|Participants will receive sleep education like the advices getting from common sleep clinic.
15759721|NCT04779333|Behavioral|LEAP|LEAP will be delivered through the typical 9 weekly BMT group sessions lasting 90 minutes. Plus wrist worn activity tracker & facebook group.
15759722|NCT04779333|Behavioral|Standard BMT|Weekly BMT groups sessions which follow the Barkley curriculum
15759723|NCT04779320|Drug|Vedolizumab IV|Vedolizumab IV
15759724|NCT04779307|Drug|Vedolizumab|Vedolizumab IV infusion.
15759725|NCT04779294|Diagnostic Test|STAN ( St wave analysis) and fetal blood sample-lactate|The CTG will be analysed by an expert group additional to the standard procedure that have been done in Labour already. The STAN analysis will be decrypted/ demasked anonymously by the Company producing these machines.
15759726|NCT04779281|Dietary Supplement|Oral Rehydration Salts supplemented with L. Rhamnosus GG|A supplement containing sodium chloride, trisodium citrate, potassium chloride, dextrose, Lactobacillus Rhamnosus GG ATC53103 HN019 strain and fructooligosaccharides
15759727|NCT04779281|Dietary Supplement|Oral Rehydration Salts only|A supplement containing sodium chloride, trisodium citrate, potassium chloride, dextrose, microcrystalline cellulose
15759728|NCT04779255|Drug|Procedure (Tumesent anesthesia)|Photodynamic therapy of vertex with a solution of 180 ml of tumescent anesthesia diffused over 1 hour in three different sub-deceasing points.
15759729|NCT04779255|Drug|Control Arm (Paracetamol)|Photodynamic therapy of vertex with 1g of paracetamol intake 1 hour before cold water is applied during the session.
15759730|NCT04779242|Drug|Omadacycline|IV for injection, oral tablets
15759731|NCT04779242|Drug|Moxifloxacin|IV solution, oral tablets
15759732|NCT04779229|Behavioral|Parent Activation|Parent Activation (PA) is comprised of concrete social learning theory steps (i.e., direct instruction, modeling, practice opportunities, and reinforcement) that aim to enhance a parent's confidence, knowledge, and ability to manage his/her child's health. PA is applicable across a range of conditions, including behavioral and psychiatric problems, and it can be delivered by varied providers, including paraprofessionals.
15759733|NCT04779229|Behavioral|Usual Services|This intervention refers to the typical techniques that JPOs employ to monitor the juveniles on their caseloads (e.g., regular meetings with youth and parents to ensure the youth is following conditions of probation and issuing swift sanctions [community service; detention] if conditions are not being followed).
15759734|NCT04779216|Drug|Romosozumab Prefilled Syringe|Romosozumab 210mg Injection monthly for 12 months
15759735|NCT04779216|Drug|Placebo|Placebo Injection monthly for 12 months
15759736|NCT04779216|Drug|Alendronate 70Mg Tab|Alendronate 70mg PO weekly starting at 12 months through 24 months.
15759738|NCT04779190|Device|Low-level laser therapy|Gallium-aluminum-arsenide diode laser device
15759739|NCT04779190|Device|Therapeutic ultrasound|Therapeutic pulsed ultrasound with a frequency of 1 MHz
15759740|NCT04779190|Other|Home-based exercise|Home-based exercises 3 days a week; each exercise comprises one set with 5 repetitions over 4 weeks.
15759743|NCT04779164|Diagnostic Test|knee ultrasonography|The knees of all patients were screened with ultrasonography device for the measurement of femoral cartilage thicknesses.
15759744|NCT04779151|Drug|Dostarlimab|Substance: immunoglobulin G4 (IgG4) humanized monoclonal antibody (mAb) that binds with high affinity to PD-1 Manufacturer: Tesaro Inc. Dose: 500 mg every 21 days for the first 4 cycles, followed by 1,000 mg every 42 days cycle (ie, Q6W)
15759745|NCT04779151|Drug|Niraparib|Substance: Inhibitor of poly-adenosine diphosphate [ADP] ribose polymerase (PARP) Manufacturer: Tesaro Inc. Dose: Flat-fixed dose (if <77kg or platelets <150,000 μL: 200mg; if >/=77kg and platelets >/= 150,000μL: 300mg)
15759746|NCT04779138|Behavioral|Increasing Willingness and Uptake of COVID-19 Vaccination|Provide/enhance knowledge, modify attitudes, motivate and provide skills and resources to reduce COVID-19 vaccine hesitancy and increase willingness and uptake in COVID-19 vaccination.
15759747|NCT04779125|Procedure|Gluteus plasty enhanced with Progrip self gripping mesh|Intervention group will be compared to historical patients in a case-control setting. Intervention group will have a mesh enhanced gluteus plasty made to reconstruct perineum after abdominoperineal resection.
15759748|NCT04779099|Behavioral|Brief 4-session intervention for borderline personality disorder|Intervention consists of weekly 50-minute 1:1 sessions focused on psycho-education, here-and-now problem solving and safety planning. One of the sessions can involve a significant other to provide psychoeducation about the disorder and to facilitate support. This intervention is detailed in a published manual.
15759749|NCT04779099|Behavioral|Treatment as usual|TAU comprises access to psychiatric assessment, medication review, and unscheduled sessions with allied health professionals using a drop-in model of care.
15759750|NCT04779060|Drug|intrathecal fentanyle|25 mic fentanyle added to heavy bupivacaine for spinal anesthesia
15759751|NCT04779060|Drug|dexamethasone|8 mg dexamethasone give intrathecally for spinal anaesthesia
15759752|NCT04779060|Drug|saline|normal saline will be mixed with bupivacaine intrathecally
15759753|NCT04779047|Drug|Remdesivir|Remdesivir will be administrated intravenously (IV) at a dose of 200 mg at day 1 then 100 mg once daily for 5 days.
15759754|NCT04779047|Drug|Hydroxychloroquine|Hydroxychloroquine will be administrated at a dose of 400 mg twice daily at day 1 then 200 mg twice daily for 5 days.
15759755|NCT04779047|Drug|Tocilizumab|Tocilizumab 800 mg once.
15759756|NCT04779047|Drug|Lopinavir/ Ritonavir|Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days.
15759757|NCT04779047|Drug|Ivermectin|Ivermectin 36 mg at day 1,3 and 6.
15759758|NCT04779034|Other|Measurement of heart rate variability|Heart rate variation will be evaluated with the Polar RS800CX model heart rate monitor
15759759|NCT04779021|Other|Hospitalisation for SARS-COV2 infection|Patients hospitalized for SARS-COV2 infection
15759760|NCT04779008|Other|remote ischemic preconditioning （RIPC）|Four five-minute cycles of upper limb ischaemia and Four five-minute pauses using a blood pressure cuff inflated to 200 mmHg.
15759761|NCT04778995|Other|Structured online training program for effective management of nursing services|"An online structured training program was prepared to reach out to manager nurses for increasing their knowledge regarding the effective management of nursing services in crisis periods. A web page was structured with the support of a professional computer engineer.
~Participant manager nurses could log into the system via a personal username and password on the main login screen of the site. In this page, there is an Informed Consent Form.
~In the Download Training Documents link; the educational content prepared in sections was presented. Educational content consisted of the issues such as: Management of Crises and Emergency Situations, Leadership in Crisis, Planning and Managing Nurse Human Power in Crisis, Supervision and Management of Patient Care, Logistics and Support Services, Communication in Extraordinary Situations, Motivation Tools Used in Extraordinary Situations, Stress Management During Crisis and Employee Adaptation and Training in Crisis."
15759762|NCT04778982|Drug|KN026 combined with Palbociclib|HR-/HER2-positive MBC will be treated by KN026 20 mg/kg and Palbociclib RP2D
15759763|NCT04778982|Drug|KN026 combined with Palbociclib and Fulvestrant|HR+/HER2-positive MBC will be treated by KN026 20 mg/kg and Palbociclib RP2D+fulvestrant 500 mg
15759764|NCT04778969|Device|drug-eluting stent|A group of percutaneous coronary intervention (PCI) using drug-eluting stents (DES)
15759765|NCT04778969|Device|drug-coated balloon|A group of percutaneous coronary intervention (PCI) using drug-coated balloon (DCB)
15759766|NCT04778956|Drug|Toripalimab|Toripalimab: 240 mg, intravenous injection over 60 minutes (Q3W); Toripalimab should be completed for 2 cycles at 1-2 weeks before surgery, and continually applied since 1-2 weeks after surgery until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, investigator decision, or 1 year.
15759767|NCT04778956|Procedure|salvage surgery|Endoscopic nasopharyngectomy is used for recurrent nasopharyngeal tumor and selective neck dissection for recurrent regional lymph node.
15759768|NCT04778943|Other|Surgery(OLIF and MIS-TLIF)|oblique lateral interbody fusion (OLIF); minimally invasive transforaminal lumbar interbody fusion (MIS-TLIF)
15759769|NCT04778930|Other|Physical Therapy|"FACE-TO FACE SESSIONS: approximately 90 minutes of Goal-directed training (activities for the activation of the muscles of the trunk, pelvis and lower limbs; and training of activities will be carried out in a functional and meaningful context, aimed at specific functional objectives, according to the interests of each participant and agreed with the participants and their families) and gait training on the treadmill for 20 minutes.
~TELEHEALTH THERAPEUTIC EDUCATION PROGRAM: Session 1: Concept and causes of CP, together with the general objectives and guidelines of the program. Session 2: The family-centered model; Sessions 3, 4 and 5: Actions Observation Therapy; Session 6: Program Evaluation."
15759770|NCT04778930|Other|THERAPEUTIC EDUCATION PROGRAM|TELEHEALTH THERAPEUTIC EDUCATION PROGRAM: Session 1: Concept and causes of CP, together with the general objectives and guidelines of the program. Session 2: The family-centered model; Sessions 3, 4 and 5: Actions Observation Therapy; Session 6: Program Evaluation.
15759771|NCT04778917|Drug|Low-Molecular-Weight Heparins Calcium Injection|We use different dose of low-molecular-weight heparins calcium injection to different interventions
15759772|NCT04778904|Biological|ChAdOx1-HBV|Chimpanzee Adenovirus Oxford 1-vectored Hepatitis B virus vaccine
15759773|NCT04778904|Biological|MVA-HBV|Modified Vaccinia Ankara-vectored Hepatitis B virus vaccine
15759774|NCT04778904|Biological|Nivolumab|Human immunoglobulin G4 monoclonal antibody
15761081|NCT04767984|Procedure|Biospecimen Collection|Undergo collection of blood samples
15759775|NCT04778891|Other|Comprehensive Medication Management services|Comprehensive Medication Management services (CMM services) is an evidence-based and patient-centred service which involves an assessment of patient's medications to determine that each medication is appropriate, effective for the medical condition being treated, safe for the patient in the presence of other medications and co-morbidities, and that the patient is able and willing to take the medications as intended. As all patient care providers need a structured, rational thought process for sound clinical decision retrieval, the Pharmacotherapy Workup was developed and adopted as a systematic problem-solving process. This process represents the cognitive work taking place in the mind of the practitioner, and is used to identify, resolve, and prevent drug therapy problems (DTP), establish therapy goals, select interventions and evaluate outcomes.
15759776|NCT04778878|Device|Mediracer® NCS|A point-of-care, hand-held nerve conduction device
15759777|NCT04778865|Dietary Supplement|Vitamin D-correction|Capsule with 50.000 UI cholecalciferol
15759778|NCT04778865|Dietary Supplement|Vitamin D-RDA|Capsule with 4.2000 UI cholecalciferol
15759779|NCT04778852|Device|Experimental: EksoGT|EksoGT is an overground wearable gait trainer. The therapy will be carried out 3 days a week for 4 weeks.
15759780|NCT04778852|Other|Functional kinematic training|Device: No device. The functional kinematic training will be delivered as comparator treatment and will be carried out 3 days a week for 4 weeks.
15759781|NCT04778839|Drug|Paclitaxel Micelles for Injection|Paclitaxel Micelles for Injection was intravenously administrated for three hours, three weeks constituted one course of treatment.
15759782|NCT04778839|Drug|Paclitaxel injection|Paclitaxel Injection was intravenously administrated for three hours, three weeks constituted one course of treatment.
15759783|NCT04778826|Procedure|Lymphadenectomy|radical bloc dissection of all mediastinal lymph node stations
15759784|NCT04778813|Drug|Artemether-lumefantrine|In each study site, children fulfilling the inclusion criteria will be assigned randomly to one of three treatment groups: AL, DHA-PPQ or As-Pyr group. Sealed envelopes each containing no more than 10 other small envelopes with randomization numbers and treatment will also be provided. These will be used over time, respecting the ascending order of the numbers to randomly distribute the eligible children after selection in each of the three treatment groups. The treatment to be administered will not be known until after the randomization process. The drugs will be administered based on weight according to the instructions from the drug manufacturer. AL will be administered with fatty food or milk according to the manufacturer's recommendations. All doses of the drug will be administered under the direct supervision of a qualified team member designated by the principal investigator.
15759785|NCT04778800|Drug|almonertinib|Patients was given a standard dose of 110mg/day of almonertinib, orally, and the first efficacy evaluation was carried out 4 weeks later. If the patient's lungs and/or other parts of the disease (PD) progress, then leave the group to receive other treatment; if the patient's lungs If the brain and other parts are stable or relieved and the brain has not progressed, continue the original dose treatment, and evaluate the effect every 8 weeks. Until the patient's lungs and/or other parts progress (PD), then leave the group to receive other treatment; if If the patient's lungs and other parts are stable or relieved and the brain is progressing, the dose of almonertinib can be increased to 165mg/day, orally ± radiotherapy (the investigator's decision), and then the efficacy will be evaluated every 8 weeks until the patient's lungs and/ Or there is progress (PD) in other parts, then the group will receive other treatment.
15759786|NCT04778800|Drug|LM-first line treatment|Patients were given a standard dose of almonertinib 110 mg/day, orally, and the first efficacy evaluation was performed 4 weeks later. If there was no disease progression in two consecutive evaluations, the dose of almonertinib was increased to 165 mg /Day, oral ± radiotherapy (decided by the investigator), continue to evaluate the efficacy every 4 weeks until the patient progresses; if there is no disease progression in two consecutive assessments, the dose of almonertinib is increased to 220 mg/day, orally ± Radiotherapy treatment (determined by the investigator), continue to evaluate the efficacy every 4 weeks until the patient progresses.
15759787|NCT04778800|Drug|LM-second line treatment|Patients were given a standard dose of almonertinib 110 mg/day, orally, and the first efficacy evaluation was performed 4 weeks later. If there was no disease progression in two consecutive evaluations, the dose of almonertinib was increased to 165 mg /Day, oral ± radiotherapy (decided by the investigator), continue to evaluate the efficacy every 4 weeks until the patient progresses; if there is no disease progression in two consecutive assessments, the dose of almonertinib is increased to 220 mg/day, orally ± Radiotherapy treatment (determined by the investigator), continue to evaluate the efficacy every 4 weeks until the patient progresses.
15759788|NCT04778787|Drug|Standard list of drugs used for acute decompensation of CHF (loop diuretics, vasodilators, digoxin, inotropic agents, vasopressors), plus dapagliflozin (Forxiga; MP-002596)|Patients will receive dapagliflozin at a dose of 10 mg daily during hospitalization in addition to ongoing therapy
15759789|NCT04778774|Procedure|Nerve block|Two different nerve block types, Adductor canal block group and Femoral nerve block group
15759790|NCT04778761|Behavioral|Home ACP Video|A video focused on Advance Care Planning and Hospice for patients with serious illness
15759791|NCT04778748|Diagnostic Test|Under-mattress sleep monitor|Under-mattress sleep monitor for patients with a confirmed diagnosis of Obstructive Sleep Apnea.
15759792|NCT04778735|Procedure|Liver Transplantation|Liver Transplantation is performed under spesific conditions to increase the life time of patients with liver diseases.
15759793|NCT04778722|Dietary Supplement|Oral probiotics|containing four Lactobacillus strains (Lactobacillus crispatus -Lbv88, Lactobacillus rhamnosus -Lbv96, Lactobacillus jensenii -Lbv116, and Lactobacillus gasseri -Lbv150)
15759794|NCT04778709|Device|Puros allograft|"Bilateral sinus augmentation procedure using the lateral window technique. Graft material combination A or B will be randomly assigned to right and left sinus.
~Each subject will receive the following bone allograft material:
~Four to six grams of commercially available human donor bone allograft (Puros Allograft Bone Particles, Zimmer Biomet, Palm Beach Gardens, FL USA) consisting of Graft A cortical and cancellous bone chips of both 250-1000 microns and 1000-2000 microns size, or Graft B for contralateral sinus: cancellous 1000-2000 microns size alone."
15759795|NCT04778696|Procedure|PASO Pacemapping|Using the PASO pacemapping visualisation module of CARTO3
15759796|NCT04778696|Procedure|Conventional Pacemapping|without visualisation in 3D mapping
15759907|NCT04777747|Other|viral and bacterial infection|a child is infected by virus and progress to bacterial infection
15759797|NCT04778683|Procedure|Virtual Reality|The investigator explained the use of VR glasses to the children in the VR group. The investigator selected two VR programs to be watched by the children. In the VR program named Amazon, the child perceives himself to be walking among the trees in the Amazon forests. The other VR program gives the child a feeling of water skiing. Before commencement of the study, the VR applications were administered to five children aged between five and ten years, and these children shared no negative feedback about the VR programs. Before the surgery, the children were allowed to watch the VR program of their choice, the average duration of which was 4.5 minutes, using the VR glasses. Parts of the device that come in contact with the children's faces were cleaned before each application
15759798|NCT04778670|Diagnostic Test|AI CAD|The Lunit INSIGHT MMG will be used as the AI CAD in our study. Initially, version 1.6.1.1 will be installed. The software version will be continuously updated with subsequent software releases, after confirming in a historic calibration dataset that the performance is improved. The operating point will be set based on a historic calibration dataset to attain a joint sensitivity of breast cancer detection of AI and first reader which is 2% higher than for first and second reader.
15759799|NCT04778670|Diagnostic Test|Radiologist reading|Standard of care, each radiologist will assess the mammography examination, making a binary flagging decision (flag the examination to continue to consensus discussion, or not)
15759802|NCT04778631|Device|Heat therapy|Application of warm compresses, soaked in hot tap water (between 38° and 44 °C), to the perineum, at each contraction or pushing effort from the start of perineum distension until birth.
15759803|NCT04778631|Device|Cryotherapy|Application of a perineal instant col pack to the perineum, after placental delivery or perineum suturing, for at least 20 minutes.
15759804|NCT04778618|Drug|Antithymocyte Globulin|Individual dose of ATG was Intravenous infused every day from day -5 to day -2 (total ATG dose was calculated based on pharmacokinetic index, within a range of 7 mg/kg to 13mg/kg). Antithymocyte globulin (ATG) was added to conditioning regimens for 4 days (days -5 and -2). Prophylaxis against graft-versus- host disease (GVHD) was performed with cyclosporine A (CsA), mycophenolate mofetil (MMF) and short-term methotrexate
15759805|NCT04778592|Drug|ETX-018810|Study Drug
15759806|NCT04778592|Drug|Placebo|Placebo
15759807|NCT04778579|Drug|ARI-0001 cells|Adult differentiated autologous T-cells from peripheral blood, expanded and transduced with a lentivirus to express a chimeric antigen receptor with anti-CD19 specificity (A3B1) conjugated with the co-stimulatory regions 4-1BB and CD3z
15759808|NCT04778566|Diagnostic Test|Cologuard test|Cologuard is a stool-DNA screening test for detecting colon cancer
15759809|NCT04778553|Diagnostic Test|iMOST X-1 Hematology Analyzer|The X-1 is a point of care automated hematology analyzer
15759810|NCT04778527|Drug|PrEP tablet and a COC as one tablet|a single over-encapsulated DPP containing a PrEP tablet and a COC
15759811|NCT04778527|Drug|PrEP tablet and a COC as two separate tablets|PrEP tablet and a COC as two separate tablets
15759812|NCT04778514|Drug|PrEP and combined oral contraceptive (COC)|Pre-exposure prophylaxis (PrEP) and a combined oral contraceptive (COC) pill
15759813|NCT04778514|Drug|PrEP and combined oral contraceptive (COC) as two separate tablets|Two separate tablets (PrEP and COC)
15759814|NCT04778501|Device|IOL implantation experimental|Mono- or bilateral implantation of toric intraocular lenses PODEYE TORIC. If only one eye qualifies for toric lens implantation due to small amount of pre-existing corneal astigmatism, one eye will be implanted with PODEYE TORIC and the contralateral eye will be receive an implantation with the monofocal parent lens PODEYE (PhysIOL sa/nv, Liège, Belgium).
15759815|NCT04778488|Device|Near-Infrared-Spectroscopy (NIRS)|Placement of 2 NIRS optodes on the patients' forehead, measurement of NIRS during cardiac arrest and up to 72h post return of spontaneous circulation
15759816|NCT04778475|Other|Intensive therapy|PT services twice a day for 3-5 days and then daily for the remainder of hospital stay
15759817|NCT04778475|Other|Standard of care therapy|PT services 3-5 times a week for 15 to 30 minutes
15759818|NCT04778462|Device|extracorporeal shock wave and conventional treament|"Extracorporeal shock wave for 700 impulses of 0.056 mJ/mm at a frequency of 10 Hz to the taut band and 300 impulses surrounding the taut band will be applied as low energy 2 sessions per week for 2 weeks The will be used as a radial type of shock wave therapy.
~Strengthening, stretching exercises and ischemic compression:
~Isometric neck extensor exercise:
~Isometric neck flexor exercise:
~Isometric neck side bending muscle exercise:
~Stretching exercise:
~Passive stretching for the neck extensor muscles:
~Passive stretching of the neck side-bending muscles:
~Ischemic compression"
15759819|NCT04778462|Device|high pain threshold ultrasound and conventional treatment for myofascial pain syndrome trigger points|"will be applied in continuous mode, with the probe placed directly on the TrP and held motionless. To elicit threshold pain, the US probe will be kept static on the TrP. Intensity gradually will be increased to the level of maximum pain the patient could bear. It will be kept at that level for 3 to 4 seconds, then will be reduced to the half-intensity level for another 15 seconds. This procedure was repeated 3 times.the intensity of US will be dependent on the patient's level of pain. intensity will be applied in the range of 0.5 to 2.0 Watt per/cm2. Patients continually report their pain level and its localization and nature High-power pain threshold US will be applied 4 times, with a 3-day interval 2 sessions per week for 2 weeks .
~1)Isometric neck extensor exercise2)Isometric neck flexor exercise3)Isometric neck side bending muscle exercise,Stretching exercise:Passive stretching for the neck extensor muscles ,stretching of the neck side-bending muscles,Ischemic compression"
15759820|NCT04778462|Other|conventional treatment for myofascial pain trigger point|"Strengthening, stretching exercises and ischemic compression:
~Isometric neck extensor exercise:
~Isometric neck flexor exercise:
~Isometric neck side bending muscle exercise:
~Stretching exercise:
~Passive stretching for the neck extensor muscles:
~Passive stretching of the neck side-bending muscles:
~Ischemic compression"
15759821|NCT04778449|Other|Medical Chart Review|Medical charts are reviewed
15759822|NCT04778449|Other|Questionnaire Administration|Complete questionnaires
15759823|NCT04778436|Dietary Supplement|T7082|Patients will take food supplementation for 12 months. For each patient : 5 visits with ophthalmogist and 6 phone call
15759908|NCT04777734|Biological|efgartigimod|an intravenous infusion of efgartigimod
15759913|NCT04777682|Procedure|ultrasound, double balloon enteroscopy|compare intestinal ultrasound versus double-balloon enteroscopy in diagnosis of malabsorption syndrome
15759824|NCT04778423|Other|Avatar Therapy|In the first session (assessment), participants will create a computerised representation of the eating disorder voice (avatar) on a computer. They will be able to manipulate the facial and voice characteristics of the avatar and will be asked to provide examples of the critical eating disorder comments most often spoken by the avatar. In the following sessions (6-8 therapy sessions), participants will interact with the avatar displayed on the computer screen for 5-10 minutes.The main goal during the interaction with the avatar is for participants to stand up to the critical comments made by the avatar and build a sense of power, control and self-awareness in the context of the eating disorder voice. The sessions will be conducted remotely, using a personal laptop or computer. This will provide patients with the opportunity to practise answering back to the eating disorder voice during a meal, a time at which the eating disorder voice is loudest.
15759839|NCT04778384|Behavioral|Micro-training to promote self-management in pain therapy|Micro-training according to the checklist & targeted discussion / dismantling of patient-related barriers based on the answers in the second part of the questionnaire (BQII Barriers Questionnaire) In this discussion, the nurses give their opinion on any patient-related barriers that become apparent after completing the second part of the questionnaire. This is not done according to a fixed template, but with the specialist knowledge and everyday experience of the nurse.
15759840|NCT04778384|Other|Sham intervention|An unstructured conversation is carried out. Patient questions are answered correctly, but there is no training, rather patient information.
15759841|NCT04778371|Other|Almonds|64 g total dry roasted, unsalted almonds per day for a total of 12 weeks
15759842|NCT04778371|Other|Placebo|200 g total calorie matched granola bar per day for total of 12 weeks
15759843|NCT04778358|Drug|Follitropin Delta, Recombinant|15 µg of follitropin delta will be administered subcutaneously daily
15759844|NCT04778345|Diagnostic Test|68Ga-FAPI PET/CT scan|Each subject receives a single intravenous injection of 68Ga-FAPI, and undergo PET/CT imaging after 18F-FDG PET/CT scan during 2 days and 1 week.
15759845|NCT04778319|Other|occlusion of tubes|to occlude the fallopian tubes
15759846|NCT04778319|Other|non occlusion of tubes|not to occlude the tubes
15759847|NCT04778306|Procedure|Transoral Laser Surgery|Remove of the laryngeal tumour via diode laser
15759848|NCT04778293|Other|Diacutaneous fibrolysis|An experienced physiotherapist in the diacutaneous fibrolysis technique will apply the treatment to the lower limb, previously randomized, in the following musculature and intermuscular septums: quadratus lumbar, gluteus maixum, biceps femoris and semitendinosus. Intervention procedure will last about 10-15 minutes
15759849|NCT04778267|Drug|Bupivacaine Hydrochloride|We hypothesize that combined ESPB and PIPB are as effective as TPVB in controlling perioperative pain in patients undergoing modified radical mastectomy (MRM) with lesser complications using bupivacaine hydrocloride
15759850|NCT04778267|Drug|Dexamethasone phosphate|used as additive to bupivacaine
15759851|NCT04778254|Other|PEEK attachment retained obturator|attachment retained obturator for management of hemi maxillectomy
15759852|NCT04778254|Other|metalic attachment retained obturator|attachment retained obturator for management of hemi maxillectomy
15759853|NCT04778254|Other|conventional obturator|clasp retained obturator for management of hemi maxillectomy
15759854|NCT04778241|Procedure|Micro-osteoperforation|Mini-implant facilitated micro-osteoperforation (MOPs) were placed in the experimental group before placing the initial leveling arch wire. MOPs were placed at three sites i.e., interproximally between mandibular canine and lateral incisor on both sides and between central incisors in the midline on labial aspect of mandible.
15759855|NCT04778228|Device|mechanical ventilation|"critically ill patients requiring mechanical ventilation (MV) were ventilated using high tidal volumes (Vt) and high airway pressures, until the pivotal ARDS net randomized controlled trial (RCT) demonstrated that a lung-protective MV strategy using a Vt of 4-8 mL/kg predicted body weight (PBW) and moderate levels of positive end-expiratory pressure (PEEP) improved survival (2). Since then, limitation of Vt to 4-8 mL/kg PBW, plateau pressures (Pplat) to a maximum of 30 cm H2O, and application of PEEP 10 -16 cm H2O represent the standard for MV in ARDS patients."
15759910|NCT04777708|Biological|Nanoplexed Poly I:C BO-112|Given by intratumoral injection
15759856|NCT04778215|Other|A progressive specific lumbar stabilization program|The aim of these programs is to optimize the stabilization and control of segmental motion of the lumbar spine. It is based on the draw-in action, hereafter called the abdominal hollowing, presented by Richardson and Jull (1995). The training program consists of three levels. Level 1 introduces the abdominal hollowing exercise in the prone and four-point kneeling position. Level 2 is a progression of these exercises and the gymnasts are also instructed to perform the abdominal hollowing standing on a balance board with slightly flexed knees while slowly moving the arms. Level 3 takes the training into sports specificity and the abdominal hollowing are to be held during three different basic trampette jumps with emphasis on good trunk and body control during jumping and landing.
15759857|NCT04778202|Diagnostic Test|blood sample collection|blood sample collection by venipuncture four both groups and MRI for breast cancr patient group
15759858|NCT04778189|Drug|Placebo|while patients in group( NS ) will receive 500-mL normal saline IV in 5-10 minutes, after spinal anesthesia
15759859|NCT04778189|Drug|i.v dexmethasone|patients in group( SD )will receive 8-mg dexamethasone IV in 500-mL normal saline after spinal anesthesia
15759860|NCT04778176|Combination Product|continuous oral delivery of levodopa/carbidopa|The system consists of a reusable custom dental retainer, its case, and a pre-filled, single-use container which continuously releases levodopa/carbidopa into the back of the mouth.
15759861|NCT04778163|Behavioral|Clinical use of humor|"Clinical study in psychiatry in young adult patients between 18 and 25 years old. The aim of the study is to evaluate the therapeutic impact of the clinical use of humor through 6 group sessions (group of 5 to 10 patients), at the rate of one hour session per week for 6 weeks.
~The investigators will form 2 groups of 5 to 10 patients matched in terms of gender, education level and score on a scale measuring their sense of humor. The participants will be asked to complete a series of tests measuring their ability to use humor, psychiatric symptoms and well-being."
15759862|NCT04778150|Device|VO 100 medical device from Mespere LifeSciences|The investigators want to show a positive relationship between SjvO2 and SvO2 in order to possibly use in the future SjvO2 measured by VO 100 as a noninvasive surrogate of SvO2 in patients undergoing liver transplantation surgery.
15759863|NCT04778137|Drug|Omalizumab|Biological: CMAB007 Biological: Xolair
15759864|NCT04778124|Procedure|Hemorrhoidal Arterial Ligation (HAL) and Recto Anal Repair (RAR)|All patients underwent hemorrhoidal artery ligation on multiple sites according to pulsations detected by the doppler transducer and mucopexy (RAR) at the sites of prolapse.
15759865|NCT04778124|Procedure|Excision of thrombosed hemorrhoid / Hemorrhoidectomy /|One patient with mucosal necrosis of the hemorrhoidal cushion postoperatively underwent hemorrhoidectomy with excision of necrotic tissues.Furthermore, 2 patients who presented with hemorrhoidal thrombosis postoperatively underwent emergency surgery with supplementary excision of the thrombosed hemorrhoid. In addition, 9 patients who experienced recurrence of hemorrhoidal disease after undergoing HAL-RAR surgery, were treated with hemorrhoidectomy according to the Milligan-Morgan procedure.
15759866|NCT04778111|Other|Measurement of the actual and perceived maximum reachable distance|A device (a table) will present luminous targets (green circles) to the subjects. Subjects will be asked to determine whether or not they are able to reach this target with their upper limb.
15759867|NCT04778098|Other|Received SMS reminder|telenursing
15759868|NCT04778085|Behavioral|Illness management and recovery|Treatment given in groups, weekly for 10-12 months.
15759869|NCT04778085|Other|Semi-structured interviews|Semi-structured individual or group interviews conducted three times with staff on each participating outpatient clinic.
15759870|NCT04778072|Dietary Supplement|Ferrous sulfate 14mg once daily|ACTIVE IRON™ (ferrous sulfate) 14 mg elemental iron once daily with matching placebo
15759871|NCT04778072|Dietary Supplement|Ferrous sulfate 25mg once daily|ACTIVE IRON™ (ferrous sulfate) 25 mg elemental iron once daily with matching placebo
15759872|NCT04778072|Dietary Supplement|Ferrous sulfate 25mg twice daily|ACTIVE IRON™ (ferrous sulfate) 25 mg elemental iron twice daily
15759873|NCT04778059|Drug|USB002|USB002 is pharmaceutically formulated Angiotensin 1-7 [A(1-7)], a non-hypertensive derivative of Angiotensin-II (A-II), and is suspended in a vehicle as a sterile solution of USB002. Depending upon cohort assignment, subjects in the USB002 group will receive one of four doses of USB002 administered intravenously (IV).
15759874|NCT04778059|Drug|Placebo|The placebo formulation will be the USB002 formulated solution without the addition of A(1-7). The placebo will be administered intravenously (IV).
15759876|NCT04778033|Other|Sperm collection|Those recruited will supply a single sperm sample 1-2 months following the second dose of the vaccination. The sample will be analyzed for macroscopic and microscopic features in the IVF laboratory and will be discarded immediately afterwards.
15759877|NCT04778007|Other|Turkish Version of Laryngopharyngeal Measure of Perceived Sensation Questionnaire|The Turkish Version of Laryngopharyngeal Measure of Perceived Sensation Questionnaire consists of 8 questions related with globus pharyngeus symptoms.
15759878|NCT04777994|Drug|ABBV-CLS-484|Oral Capsule
15759879|NCT04777994|Drug|Programmed Cell Death-1 (PD-1) Inhibitor|Intravenous (IV) infusion
15759880|NCT04777981|Dietary Supplement|CBDRA60 supplement|CBD is a non-psychotropic cannabinoid that has a broad spectrum of well-established anti-inflammatory and immunomodulatory effects. Red algae (Rhodophyta) are known for their potent anti-viral properties, non-toxicity and for being well tolerated in humans [15, 16]. Rhodophyta contain several sulfated polysaccharides that exhibit high antiviral activity against enveloped viruses.,
15759881|NCT04777981|Dietary Supplement|Placebo|Placebo
15759882|NCT04777968|Drug|Silver diamine fluoride|a layer of 38% SDF solution was topically applied to the cavity using a micro brush, immediately followed by a saturated Potassium Iodide KI solution using a micro brush also, then a creamy white precipitate was immediately formed, KI was applied until the white precipitate turned clear.
15759911|NCT04777708|Biological|Pembrolizumab|Given IV
15759912|NCT04777695|Other|Decibel Monitor|Placement of a TeckPro data logging sound decibel meter at all patient bed-spaces to measure concurrent sound levels 24 hours per day, over a one (1) month period. Peak and mean sound levels per hour will be collected by the decibel monitor. Sound collected every 5 minutes will be logged by the decibel monitor and downloaded onto manufacturer software daily; data will then be imported into Microsoft Excel for further data analysis.
15759883|NCT04777955|Other|core stabilization exercises|"Core is at the center of almost all kinetic chains in the body. Core force, balance, and motion control maximize all kinetic chains of upper and lower limb function. A stable and strong core can contribute to more efficient use of the lower extremities. Core stability is defined as the ability of the lumbo-pelvic hip complex to prevent bending of the vertebral column and return to balance after perturbation.
~Neuromuscular electrical stimulation (NMES) is a technique in which muscle contraction is electrically stimulated in the area where the surface electrodes are connected. It improves secondary muscle atrophy and weakness in immobilization by preventing a decrease in muscle protein synthesis.
~Kinesiological banding (CT) is a treatment method used in the treatment of various musculoskeletal and neuromuscular deficits. The mechanism of action of CT is to facilitate muscle activation, increase blood and lymph circulation and reduce pain due to neurological suppression."
15759884|NCT04777942|Procedure|neo-TACE-HAIC+Surgery|transartery chemoembolization with lipiodol and EADM, FOLFOX (Oxa 85mg/m2 2h+CF 400mg/m2 2h +5FU 400mg/m2 10min+5FU 1200mg/m2 23h)-based artery infusion chemotherapy, followed by hepatic resection
15759885|NCT04777942|Procedure|Surgery alone|hepatic resection remove the liver tumors
15759886|NCT04777929|Other|test Phthalates, estrogen and progesterone|test mothers Phthalates in their urine, and test estrogen and progesterone receptor in placental tissue
15759887|NCT04777903|Other|collect date about all participants|a standardized and structured questionnaire that included information on age, residence, education, pregnancy history, disease history, height, and conception method, after obtaining the consent of all participants.
15759888|NCT04777890|Other|suboccipital inhibition|The therapist will seat at the patient's head height and place his second, third, fourth and fifth fingertips'over the patient's suboccipital area during a 10-minute period.
15759889|NCT04777890|Other|INYBI|The therapist will place the INYBI at the suboccipital area, specifically placing the fingers of the instrument at the lower border of the occipital. If needed, a rolled towel will be placed behind the INYBI, in order to maintain the physiological lordosis, checking out that the patient doesn't make a cervical extension. Then the therapist will press the vibration button and turn it off after 10 minutes. All patients will receive the treatment with the INYBI's hardest head with a 50 HZ frequency.
15759890|NCT04777890|Other|INYBI + upper cervical manipulation|The participant will also be treated with the INYBI during a 10-minute period. After that, the therapist will carry out the upper cervical manipulation technique. Keeping the patient's head on an upper cervical flexion position, the therapist will turn his/her head to the maximum possible rotation, always maintaining its longitudinal axis. Once this is done, a high velocity and short articular amplitude manipulation in rotation will be carried out
15759891|NCT04777877|Other|Pain Neuroscience Education delivered via a Virtual Reality Headset|Pain educational videos (5) and guided imagery 360 degree nature videos (5)
15759892|NCT04777864|Behavioral|Decision Aid|In addition to usual care, participants (parents and adolescents) receive the newly developed decision aid as part of their clinic visit(s). Clinicians receive an implementation guide to facilitate use of the decision aid.
15759893|NCT04777851|Drug|Regorafenib in combination with nivolumab|Randomized patients will receive regorafenib at a dose of 90 mg per day by mouth on days 1 to 21 of a 28-day cycle, in combination with nivolumab 480 mg using a 30-minute intravenous infusion, starting on day 1 of a 28-day cycle, every 4 weeks.
15759894|NCT04777851|Procedure|Transarterial Chemoembolization (TACE)|"Patients will be treated with transarterial chemoembolization (TACE) on-demand according to the clinical site's standards, with the goal of controlling all known liver lesions. Either conventional TACE (cTACE) or drug-eluting bead transarterial chemoembolization (DEB-TACE) may be used (as long as it is consistently applied for all patients at a given clinical site)."
15759895|NCT04777838|Drug|Citalopram 10 MG|10 mg of citalopram every day
15759896|NCT04777838|Drug|Amitriptyline|25mg of Amitriptyline every
15759897|NCT04777838|Device|Bite Splint|Night use of occlusal splint
15759898|NCT04777825|Other|Heart rate variability biofeedback training (Symbiocenter)|12 sessions of thirty minutes. Patients will participate through several serious game associated with HRV biofeedback training
15759899|NCT04777825|Other|psychoeducation session|Each patient will therefore be presented individually with a Powerpoint consisting of 35 slides divided into 4 sub-sections explaining in a fun and educational format the physiological model of stress, the respiratory function and its benefits, presentation of various relaxation techniques and recommendations for reading (stress management, letting go, mindfulness meditation) and other tools to help relaxation (smartphone applications).
15759900|NCT04777812|Diagnostic Test|Rectal and buccal swabs|The oral and intestinal flora is collected from buccal and rectal swabs.
15759901|NCT04777799|Device|URGOnight|"URGOnight is a daytime brain training solution (CE marked) aim at improve the quality of sleep. The device consists of an electroencephalographic (EEG) measuring strip connected to a mobile application. The latter is available free of charge on Android and iOS in various mobile application stores (Google Play Store and App Store).
~URGOnight is a wireless device, it connects via Bluetooth® Low Energy (BLE) to the URGOnight mobile application running on a smartphone. The EEG data is broadcast via a BLE protocol, and the standard Bluetooth® operating distance has a range of 10 meters.
~To use the URGOnight solution, the user must authorize the application to access his phone's memory to store his usage data and must also authorize the geolocation of his phone to enable BLE connection. This data is not recorded but is necessary for the proper functioning of the solution."
15759902|NCT04777786|Other|Physical Therapy|Individualized physical therapy treatments will be provided based on impairments identified during assessments. Treatment may include but is not limited to the following: passive, assisted and active ROM, manual therapy, soft tissue massage, myofascial release, therapeutic activities and exercise and patient education. Treatment duration and frequency will be specific to each patient, providing personalized care. This type of intervention is considered a pragmatic approach, which will allow for generalization of the results due to the similarity with clinical practice.71 Pilot data indicates women will receive physical therapy intervention 1-2x/week for 3-6 weeks beginning ~4 weeks after surgery (x̄=10 visits).
15759903|NCT04777773|Other|dual-task training|dual-task training
15759904|NCT04777760|Drug|one dose of surfactant replacement|the preterm infants diagnosed with NRDS and/or NARDS will be administrated with only one dose of surfactant
15759905|NCT04777760|Drug|two and more doses of surfactant replacement|the preterm infants diagnosed with NRDS and/or NARDS will be administrated with two and more doses of surfactant
15759914|NCT04777669|Other|Noise Reduction|In within subject design, listeners will have background noise removed by a noise reduction algorithm
15759915|NCT04777656|Dietary Supplement|Phase1 : CDED/Modulen™IBD® + Maintenance therapy|from D0 until M2: Phase 1 (2 months run-in phase with CDED protocol + maintenance therapy, with the exception of corticosteroid that have to be tapered and stopped until M2.)
15759916|NCT04777656|Dietary Supplement|Phase2 and 3 :|from M2 until M4 CDED phase 2 (introduction of a selected number of additional food). From M4 until end of the study CDED phase 3 (enlargement of number of additional foods and allowance of some initially excluded foods).
15759917|NCT04777643|Drug|Cannabidiol|Participants will receive a single 600mg oral dose of Epidiolex (cannabidiol) 2 hours prior to fMRI scanning.
15759918|NCT04777643|Other|Placebo|Participants will receive a single oral dose of placebo 2 hours prior to fMRI scanning.
15759919|NCT04777630|Diagnostic Test|None, neuroimaging|Observation only to observe differences in neuroimaging
15759920|NCT04777617|Other|DD-cfDNA|We are obtaining samples for donor derived cell free DNA in an observational manner. There is no intervention in this study
15759921|NCT04777604|Other|Organoid|The investigators create organoid from the pancreatic cancer tissue obtained via EUS-FNA and EUS-FNB within the pancreatic cancer diagnostic process. And also the investigators create organoid from the pancreatic cancer tissue obtained after surgery as part of the pancreatic cancer treatment process. Check for the reactivity to anti-cancer drugs through cell viability assay after treating with various anti-cancer drugs, such as anti-cancer drugs used as neoadjuvant chemotherapy for pancreatic cancer to the organoid. Also, perform genomic analysis on each organoid, and then check if there are any unique genomic mutations for each organoid. By recognizing the relationship between the unique genomic mutations and reactivity to the anti-cancer drug within patients with resectable pancreatic cancer after neoadjuvant chemotherapy, the investigators aim to strategize appropriate neoadjuvant chemotherapy before surgery, thus developing a platform to predict the outcomes of each patient.
15759922|NCT04777591|Drug|Liposomal bupivacaine TAP block|Group will receive Liposomal bupivacaine TAP block (mixed with plain bupivacaine) intraoperatively during free flap breast reconstruction as part of the multimodal pain control.
15759923|NCT04777591|Drug|Bupivacain|Group will receive plain bupivacaine TAP block intraoperatively during free flap breast reconstruction as part of the multimodal pain control.
15759924|NCT04777578|Other|Dry needling|Dry needling based on fast-in fast-out technique in the teresa major muscle
15759925|NCT04777565|Other|Robotic surgery|Cochlear implant surgery with HEARO procedure
15759926|NCT04777552|Other|diazepam (or equivalence if other benzodiazepine)|
15759927|NCT04777539|Other|At-home natalizumab treated MS patient|"MS patient who are treated with natalizumab in at-home hospitalization (HAD) setting / according at-home hospitalization program"
15759928|NCT04777526|Other|Proprioception exercises|Exercises for recognition of thumb position and thumb force sense.
15759929|NCT04777526|Other|Joint protection program|Reeducation in the activities daily life
15759930|NCT04777526|Other|Thumb orthosis|Thumb night orthosis
15759931|NCT04777526|Other|Manual distraction|Manual distraction of CMC joint
15759932|NCT04777513|Procedure|CCTA (Coronary Computed Tomography Angiography)|Per the protocol, patients had a coronary computed tomography angiography within standard of care before the enrollment to the study.
15759933|NCT04777513|Procedure|ICA (Invasive Coronary Angiography)|Per the protocol, patients will have an Invasive Coronary Angiography within standard of care.
15759934|NCT04777513|Procedure|FFR (Fractional Flow Reserve)|Per the protocol, patients will have a Fractional Flow Reserve procedure within standard of care.
15759935|NCT04777513|Device|CNBP measurement|Per the protocol, patients will have the measurement of the resting Continuous Non-Invasive Blood Pressure (CNBP). The signal is required for iSIL-FFR technology.
15759936|NCT04777513|Device|iSIL-FFR|Per the protocol, non-invasive FFR measurements will be perfomed via iSIL-FFR technology for the enrolled patients.
15759937|NCT04777500|Device|Auricular transcutaneous electrical nerve stimulation device|We are investigating whether taVNS can relieve chronic pain symptoms associated with Fibromyalgia.
15759938|NCT04777487|Diagnostic Test|GCF obtaining|4 samples of gingival crevicular fluid, 1 from each quadrant of the patient's jaw, were collected by means of paper strips.
15759939|NCT04777474|Diagnostic Test|Enhanced contact endoscopy|The study subjects will undergo enhanced contact endoscopy - studied imaging technique
15759940|NCT04777474|Diagnostic Test|Narrow band imaging|The study subjects will undergo narrow band imaging - comparator procedure
15759941|NCT04777474|Diagnostic Test|IMAGE1S imaging|The study subjects will undergo IMAGE1S imaging - comparator procedure
15759942|NCT04777461|Other|Survey on patient's perspectives on the development of an structured education programme for PCOS|The outcome of this survey will help with developing curriculum for the structured education programme.
15759943|NCT04777461|Other|Pre-pilot questionnaire|The questionnaire is aimed to capture the knowledge and expectations of the participants from taking part in the educational sessions.
15759944|NCT04777461|Other|Piloting the structured education programme for PCOS|Piloting the education program through 2 educational group sessions
15759945|NCT04777461|Other|Post-pilot questionnaire|The questionnaire aimed to capture participant's satisfactions and knowledge gained by taking part in the pilot study
15759946|NCT04777461|Other|cognitive outcomes outcome evaluation form|This aimed to capture skills developed, knowledge gained and changes in participants behaviour and perceptions by taking part in the pilot study.
15759947|NCT04777448|Procedure|telerehabilitation|24 sessions (less Thant 1h hour each) of tele rehabilitation. Patients can choose among several activities (gym, dance, cardio training, ...)
15759948|NCT04777435|Diagnostic Test|Therapeutic orientation test for TMA|Therapeutic orientation test for TMA performed on blood sample at inclusion, first visit at 1 month and last visit at 6 months.
15759949|NCT04777422|Drug|Defibrotide|Defibrotide 6.25 mg/kg IV q6h up to 7 days
15759954|NCT04777383|Drug|Acetylcholine|Iontophoretic administration of 5 different concentrations of acetylcholine
15759955|NCT04777383|Drug|Norepinephrine|Iontophoretic administration of 5 different concentrations of norepinephrine
15759956|NCT04777383|Drug|Phenylephrine|Iontophoretic administration of 5 different concentrations of phenylephrine
15759957|NCT04777383|Drug|Atropine|Iontophoretic administration of 5 different concentrations of atropine
15759958|NCT04777383|Drug|Neostigmine|Iontophoretic administration of 5 different concentrations of neostigmine
15759959|NCT04777383|Drug|Sterile water|Iontophoretic administration of sterile water
15759960|NCT04777370|Other|posterior glide mobilization|The participant will be positioned supine on a plinth, with their scapula stabilized against a firm wedge on the table, and the shoulder joint in the resting position (approx. 55 degrees abduction, 30 degrees horizontal adduction, and slight external rotation). With the extremity held in the same position, the researcher will then apply a grade III (into tissue stretch) PG mobilization. This will consist of five 30-second bouts of sustained gr III posterior glide mobilizations.
15759961|NCT04777370|Other|Sleeper stretch|All participants randomized to the stretching group will perform five 30-second holds of the sleeper stretch. This is performed by lying on the side to be stretched, elevating the upper arm to 90° on the support surface with the elbow bent 90°, then passively internally rotating the shoulder with force provided by with the opposite arm.
15759962|NCT04777370|Other|thoracic manipulation|"Individuals will then undergo a single supine grade V thrust manipulation. All manipulations will take place at the T3-4 segment. If a cavitation (pop) is not heard or felt by either the subject or examiner, a second thrust will be performed."
15759965|NCT04777344|Behavioral|Tobacco Treatment Specialist (TTS) intervention|A trained Tobacco Treatment specialist (TTS) embedded in the multi-disciplinary CF care team will provide tobacco use counseling to smoking caregivers of children with CF.
15759966|NCT04777331|Drug|Prasinezumab|Prasinezumab will be administered as an IV infusion to participants Q4W.
15759967|NCT04777331|Drug|Placebo|Prasinezumab placebo will be administered to participants.
15759968|NCT04777318|Other|Conventional physiotherapy|A total of 12 sessions of conventional physiotherapy program for 4 weeks will be applied 3 days a week. The conventional physiotherapy program will include 20 min hotpack , 10 min ultrasound, 20 min conventional (Transcutaneous electrical nerve stimulation) TENS application.
15759969|NCT04777318|Other|Conventional physiotherapy and Muscle Energy Technique|In addition to conventional therapy, the muscle energy technique will be applied to the individuals in the second group at the same frequency. Muscle energy technique will be applied to the upper trapezius, sternocleidomastoideus , scalene (anterior-medius-posterior) and levator scapula muscles. According to the MET post-isometric relaxation method, each muscle will be applied as one set (each set includes three repetitions). The patient will be asked to perform a 7-second isometric contraction corresponding to 20% of the maximum isometric contraction force in the area where the limitation is felt. After the application, the patient will be asked to breathe and relax. The stretching will be kept beyond the resistance barrier for 30 seconds and then the technique will be repeated by taking the neck back to the barrier point.
15759970|NCT04777318|Other|Conventional physiotherapy and Cervical Mobilization Techniques|Cervical mobilization techniques will be applied to the individuals in the third group in addition to conventional physiotherapy at the same frequency. In the first few sessions, bridging and manual traction techniques will be applied in 3-5 repetitions. In the next sessions, in addition to these techniques, rotation with 3-5 repetitions of manual traction, anteroposterior sliding with traction and cervical lateral shift techniques will be applied. Vertebrobasilar Insufficiency Test will be applied to all participants to determine the appropriateness of cervical mobilization. Before mobilization, a deep friction massage will be applied on painful spasmic nuchal muscles for 3-4 minutes in order to increase blood circulation and relax tense tissues.
15759971|NCT04777305|Other|Physical activity training|Participants will be randomized into either one of three intervention groups (aerobic training, resistance training, or combined training comprised of resistance and aerobic training) and a control group. Training is described in the arm description section.
15759972|NCT04777292|Device|Use of a mobile health application until app completion|Participants are asked to use ESTOCMA app approximately during 10 days, until app completion. This app has been designed to increase knowledge about obsessive-compulsive disorder (OCD), help seeking attitudes, and reduce stigmatizing attitudes. It consists in a game in which participants are asked to fight against the OCD stigma monster through ten missions. Participants have to liberate 10 characters who are prisoners of EsTOCma monster.
15759973|NCT04777279|Behavioral|individual physical exercise group|The participants in physical exercise group will receiving individual physical exercise lead by physiological therapist for 60 minutes/ three times weekly for 12 weeks.
15759974|NCT04777279|Dietary Supplement|individual Branched-Chain Amino Acids supplements group|The participants in nutrition supplements group will receiving Branched-Chain Amino Acids 5 g Branched-Chain Amino Acids every day for 12 weeks.
15759975|NCT04777279|Other|combination of physical exercise and nutrition supplements group|The participants in physical exercise group will receiving physical exercise lead by physiological therapist for 60 minutes/ three times weekly for 12 weeks and 5 g Branched-Chain Amino Acids every day for 12 weeks.
15759976|NCT04777266|Behavioral|Musictherapy|The session-based intervention programme was designed with an integrated and multimodal perspective of music therapy [37], which allows the combination of active and passive activities together with focuses and perspectives based on empirical evidence [38]. It was implemented using a process-based approach, adapting content to different phases in the process: initial contact, managing resistance, confidence building, relationships, awareness, and closure. The central focus is on the patient and to adapt and remain flexible in the sessions in accordance with the capabilities and needs of the group members. Different perspectives are integrated via nonverbal communication. The layout and any changes to the setting are made in a gradual way in keeping with the process to foster feelings of security and belonging. Sessions begin with a brief period of breathing which then moves into warming-up and free-expression using instruments, followed by the central activity and the closure.
15760036|NCT04776850|Drug|Mycophenolate Mofetil|Given IV or PO
15759977|NCT04777253|Other|Biofeedback method|"Patients in the study group will participate in training with visual biofeedback, aimed to improve motor function of the arm. The exercise will be performed using a Biometrics device. The biofeedback training will be carried out for 30 minutes per day.
~Health-resort based rehabilitation The patients will participate in a three-week rehabilitation program (from Monday to Friday), with the treatments and therapies continued for up to two hours per day.
~The program will include: group and individual exercise (active and assisted exercises, manipulation exercise, PNF-based practice, balance and breathing exercise), manual massage, physical treatments, such as: laser, whirlpool therapy, mud compress therapy, carbonic acid therapy, TENS therapy, BIO-V lamp, and localized cryotherapy."
15759978|NCT04777253|Other|Health-resort based rehabilitation|"The patients will participate in a three-week rehabilitation program (from Monday to Friday), with the treatments and therapies continued for up to two hours per day.
~The program will include: group and individual exercise (active and assisted exercises, manipulation exercise, PNF-based practice, balance and breathing exercise), manual massage, physical treatments, such as: laser, whirlpool therapy, mud compress therapy, carbonic acid therapy, TENS therapy, BIO-V lamp, and localized cryotherapy"
15759979|NCT04777227|Drug|Lidocaine injection|2% (20mg/ml) lidocaine solution
15759980|NCT04777227|Drug|Physiological water injection|0.9% sterile sodium chloride water
15759981|NCT04777227|Procedure|Debridement|A debridement was completed using a scalpel and number 15 blade, a podiatry drill and a spherical podiatry burr.
15759982|NCT04777227|Procedure|Needle insertion|A 27-gauge needle on a 3 mL syringe was inserted at 10 to 15 degrees with the bevel facing up approaching from the IPK's right side
15759983|NCT04777214|Device|Repetitive Transcranial Magnetic Stimulation|Active TMS will be at 90% motor threshold
15759984|NCT04777214|Device|Sham TMS|Sham TMS will be administered
15759985|NCT04777201|Drug|Faricimab|Faricimab 6 mg will be administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen for the duration of the study.
15759986|NCT04777201|Other|Sham Procedure|The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. The sham procedure will be administered to participants as appropriate during the first 12 weeks of this study in order to maintain the masking of the initial faricimab PTI.
15759987|NCT04777188|Procedure|Percutaneous Intramyocardial Septal Radiofrequency Ablation for hypertrophic obstructive cardiomyopathy|Under transthoracic echocardiography (TTE) guidance, the puncture site is positioned at the apex. A guiding line is applied along the septal long axis and the radiofrequency ablation electrode needle(17G, Cool-tip™ RF Ablation System and Switching Controller;Medtronic, Minneapolis, MN, USA) pierced towards the hypertrophic anterior interventricular septum (AIVS) 8-10 mm from the subaortic valve. Each ablation lasts for up to 12 min and the ablation power is gradually increased from 30-40W. Then, the ablation needle is withdrawn 10 mm to prepare for the next application. Overall, 3-4 applications are performed in each patient. The ablation creates an area of thermal coagulative myocardial necrosis that appears as a hyperechogenic reflection detected by TTE. If deemed necessary, we repeat the procedure at the posterior interventricular septum (PIVS).
15759988|NCT04777175|Drug|immunity therapy|The patient receives immunotherapy
15759989|NCT04777162|Drug|Tislelizumab|For included participants, tislelizumab would be administrated 200mg q3w iv.
15759990|NCT04777162|Drug|Anlotinib|Patients will be administrated with Anlotinib 12mg p.o. d1-d14 q3w.
15759991|NCT04777149|Other|transcranial Random Noise Stimulation (tRNS)|Two electrodes will be placed over the targeted areas on participant's head. A current of random frequency and intensity will be delivered. TRNS will be applied during the first 20 min of functional task practice.
15759992|NCT04777149|Other|transcranial Direct Current Stimulation (tDCS)|Two electrodes will be placed over the targeted areas on participant's head. A continuous low intensity current will be delivered. TDCS will be applied during the first 20 min of functional task practice.
15759993|NCT04777149|Other|sham-stimulation|Two electrodes will be placed over the targeted areas on participant's head. A continuous low intensity current will be delivered for 1- 2 min.
15759994|NCT04777136|Other|Home visit and comprehensive geriatric assessment|Home-visit from the geriatric team, who will do a full geriatric assessment and targeted interventions
15759995|NCT04777136|Other|Control group, no designated follow up|Only follow-up on patients own initiative with contact to the general practitioner
15759996|NCT04777123|Other|sitting position|patients will be left seated for 2 minutes after subarachnoid injection
15759997|NCT04777110|Drug|Esketamine|The main anesthesiologist standing on the right side of the patient injects esketamine (0.25 mg/kg) sequentially, and then propofol (1.5 mg/kg) is injected 1 minute later for 30 s;
15759998|NCT04777110|Other|Saline|The main anesthesiologist standing on the right side of the patient injects saline (0.05ml/kg) sequentially, and then propofol (1.5 mg/kg) is injected 1 minute later, the injection time is 30 s
15759999|NCT04777097|Other|Blood sample|Two blood sample will be drawn. On the day of operation and the first postoperative day.
15760000|NCT04777084|Drug|IBI318|IBI318, 300 mg, administered by intravenous infusion on the first day of each cycle, 1 cycle every 2 weeks (Q2W), continuous medication; lenvatinib 20 mg, orally, continued medication until disease progression, death, toxicity is intolerable, Withdrawal of informed consent, start a new anti-tumor treatment or terminate the treatment for other reasons specified in the plan, the maximum use time is 2 years.
15760001|NCT04777071|Procedure|Computed Tomography|Undergo PET/CT scan
15760002|NCT04777071|Drug|Gallium Ga 68 Gozetotide|Given IV
15760003|NCT04777071|Procedure|Positron Emission Tomography|Undergo PET/CT scan
15760037|NCT04776850|Procedure|Plasmapheresis|Undergo plasmapheresis
15760038|NCT04776850|Biological|Rituximab|Given IV
15760039|NCT04776850|Drug|Tacrolimus|Given IV or PO
15760040|NCT04776837|Behavioral|Observational Cohort|Patients will be followed by collecting clinical data, biospecimens, and quality of life assessment
15760041|NCT04776811|Device|Continuous glucose monitoring system|Medtronic Guardian Connect with Guardian Sensor 3
15760042|NCT04776798|Other|Taping|Tape applications will repeat twice per week, for 4 weeks.
15760071|NCT04776551|Procedure|Percutaneous fixation of acute Scaphoid fractures|Percutaneous Trans-trapezial fixation of acute Scaphoid fractures by Herbert screw
15761082|NCT04767984|Drug|Placebo Administration|Given PO
15760004|NCT04777045|Drug|Diltiazem Hydrochloride|"Diltiazem hydrochloride is a calcium ion influx inhibitor (slow channel blocker or calcium antagonist). It is a white to off-white crystalline powder with a bitter taste. It is freely soluble in water, methanol and chloroform. It has a molecular weight of 450.98.
~It provides its therapeutic effects by blocking the influx of calcium ions into vascular smooth and cardiac muscle cells during membrane depolarization. The decrease in intracellular calcium causes relaxation of smooth muscle cells and cardiac myocytes by inhibiting actin-myosin interactions. Vasodilation subsequently results in decreased peripheral vascular resistance. The antihypertensive effect of diltiazem in hypertensives is greater than in normotensives.
~Diltiazem is registered for the treatment of hypertension, heart rate control in supraventricular tachycardia, chronic stable angina pectoris and angina pectoris resulting from coronary artery spasm."
15760005|NCT04777045|Drug|Placebo|Matching placebo capsules, given QD per oral use. Placebo capsules will be used in the same manner with the same dose titration.
15760006|NCT04777019|Other|Not applicable as standard of care Colonoscopy|Not applicable since not an intervention
15760007|NCT04777006|Behavioral|Problem Management Plus|"PM+ is a cognitive-behavioral intervention that trains recipients to improve their management of practical problems, and uses the term problem management rather than problem solving to emphasize that many problems encountered by individuals living in adverse circumstances may not be solvable. The plus in PM+ underscores additional evidence-based behavioral strategies incorporated into the model, including: stress management strategies, behavioral activation, and social support strengthening. In total, PM+ comprises five sessions held once per week for 1.5. to 2.5 hours per session. The model has shown success in reducing depression symptoms in low-resource settings such as Nepal and Pakistan.4"
15760008|NCT04777006|Drug|Antidepressant Therapy|"Fluoxetine, a serotonin selective reuptake inhibitor (SSRI), and amitriptyline, a tricyclic antidepressant (TCA), are part of Malawi's national formulary. Neno District supply chain is supported by PIH, which reduces stock-outs relative to those observed in other Malawian settings. Fluoxetine is typically the first drug of choice because it is safer and better tolerated.
~Daily dose will commence at 20 mg of fluoxetine, or 25 mg of amitriptyline. At monthly follow-up visits, a dose increment or medication change may be considered based on measures of treatment response and side effects, using an Antidepressant Side Effect Checklist. This algorithm-based process will be repeated every other week until the patient is fully responding to treatment (PHQ-9 < 5) for a period of three months. Dose escalations of more than one increment and medication changes will be reviewed with the doctor-in-charge. If on ADT at end of study, it will be sustained as part of usual care."
15760009|NCT04776993|Drug|Methimazole|Methimazole for 72 weeks
15760010|NCT04776993|Procedure|Radioiodine or thyroidectomy|Treatment with radioiodine or with thyroidectomy
15760011|NCT04776980|Diagnostic Test|Post Feraheme Infusion MRI|All participants will receive a ferumoxtyol (Feraheme) infusion 20-28 hours prior to a head MRI. In addition, a blood draw for liquid biopsy targeted tissue sampling during surgery and special iron and macrophage staining on the tumor tissue.
15760012|NCT04776967|Procedure|Hyperbaric Compression Profile|A total of 4 randomized hyperbaric treatment compression profiles (accepted standards of care) will be alternated over the patients course of treatment on a daily basis daily to the prescribed treatment depth.
15760013|NCT04776954|Device|Forced Air Warming System|"The forced air warming system has a heater unit that blows air through a conduit to an air blanket that inflates with forced air that circulates throughout the blanket, and exits through tiny perforations on the patient-side of that blanket. The heat primarily warms the subject through convective means. As the warmed air escapes through the perforations in the blanket, it creates an environment of continuously circulating warm air that is in contact with the skin."
15760014|NCT04776954|Device|Resistive Blanket Warming System|This blanket is equivalent to an operating-room-safe electric blanket. Through a power cord, a separate power source powers a semiconductor layer within the resistive blanket to generate heat. The heat primarily warms the subject by conductive warming through direct skin contact, and, secondarily, by warming the air around the participant in areas where there is no direct skin contact.
15760015|NCT04776941|Behavioral|Behavioral Intervention|Read positive messages
15760016|NCT04776941|Behavioral|Behavioral Intervention|Write about positive experiences
15760017|NCT04776941|Behavioral|Behavioral Intervention|Write about neutral topics
15760018|NCT04776941|Behavioral|Behavioral Intervention|Read neutral messages
15760019|NCT04776941|Other|Quality-of-Life Assessment|Ancillary studies
15760020|NCT04776941|Other|Questionnaire Administration|Complete questionnaires
15760021|NCT04776928|Behavioral|Push reports|"Surgeons randomized to provider-level push report notifications will receive an email displaying their personal prescribing performance compared to Michigan Opioid Prescribing Engagement Network (OPEN) prescribing guidelines and their de-identified peers.
~The push report will also include a link to the secure MSQC data platform that displays more information about the case so the surgeon can further investigate prescribing information. The email will also contain contact information for the study team so as to help any surgeons troubleshoot, learn more, request to stop receiving reports, etc.
~Following receipt of the push report surgeons will also be invited to participate in a qualitative interview. The purpose of this interview is to learn about surgeons' preferences and experiences with the push reports."
15760022|NCT04776915|Diagnostic Test|Ultrasound and Hysterosalpingography|Ultrasound and Hysterosalpingography
15760023|NCT04776902|Behavioral|Survey|Patients will fill a questionary with 8 questions.
15760024|NCT04776889|Drug|Rosuvastatin 20mg|Rosuvastatin 20mg/day for 6 months added to bilateral subcapsular orchiectomy
15760025|NCT04776889|Procedure|surgical castration|bilateral subcapsular orchiectomy
15760026|NCT04776876|Biological|Retifanlimab|Given IV
15760027|NCT04776876|Drug|Telotristat Ethyl|Given PO
15760028|NCT04776863|Device|optical biometry measurement|The measurements of the individuals using smokeless tobacco and those who do not were taken by optical biometry.
15760029|NCT04776850|Drug|Bortezomib|Given IV
15760030|NCT04776850|Drug|Busulfan|Given IV
15760031|NCT04776850|Drug|Cyclophosphamide|Given IV
15760032|NCT04776850|Drug|Dexamethasone|Given IV
15760033|NCT04776850|Drug|Fludarabine Phosphate|Given IV
15760034|NCT04776850|Procedure|Hematopoietic Cell Transplantation|Undergo HCT
15760035|NCT04776850|Biological|Lapine T-Lymphocyte Immune Globulin|Given IV
15760043|NCT04776785|Device|Curodont™ Repair|"It is a product used in biomimetic remineralization of initial carious lesions. The product consists of smart P11-4 peptide molecules (CUROLOX® TECHNOLOGY) that within the lesion the molecules self-assemble to a 3D matrix. This bio-matrix enables the regeneration of the tooth tissue.
~Test 1 lesions will be cleaned with a prophylaxis paste and isolated with cotton rolls. Then, the pellicle will be removed using 2% sodium hypochlorite (20 sec) and the inorganic deposits will be removed using 35% phosphoric acid (20 sec). The tooth surface will be rinsed with water and dried. Thereafter, Curodont™ Repair will be applied in compliance with the manufacturers' instructions and left for 5 minutes."
15760044|NCT04776785|Device|MI Varnish™|"MI Varnish™ is a 5% sodium fluoride (NaF) varnish that has a desensitizing action when applied to tooth surfaces. The product also contains RECALDENT™ (CPP-ACP): Casein Phosphopeptide-Amorphous Calcium Phosphate. The application leaves a film of varnish on tooth surfaces and also facilitates the tooth remineralization.
~Test 2 lesions will be isolated with cotton rolls. Then, MI Varnish ™ will be applied as a thin layer in equal thickness with a disposable brush in accordance with the manufacturers' instructions. Thereafter, the tooth surface will be moistened with water or saliva to ensure that the material adheres to the applied area."
15760045|NCT04776785|Device|Profluorid® Varnish|"Profluorid® Varnish is a 5% sodium fluoride (NaF) varnish for surface application to enamel and dentin. The product will adhere to wet surfaces and is tolerant to moisture and saliva. Profluorid® Varnish is an ethanolic suspension of colophony with artificial flavors and sweetened with xylitol. It is also used in the remineralization of initial caries.
~Control lesions will be isolated with cotton rolls. Then, Profluorid® Varnish will be applied as a thin layer in equal thickness with a disposable brush in accordance with the manufacturers' instructions. Thereafter, the tooth surface will be moistened with water or saliva to ensure that the material adheres to the applied area."
15760046|NCT04776772|Dietary Supplement|Synbiotic complement|"On two separate days, the baseline-tests and final-tests were conducted. All participants performed a series of tests, before which they had to fast. The order and schedule (8 am) of the tests was the same for the final-test and the same materials and procedures were used. A period of 30 consecutive days elapsed between the base-line and final tests, during which the participants had to ingest their supplement (synbiotic)."
15760047|NCT04776772|Dietary Supplement|Placebo|"On two separate days, the baseline-tests and final-tests were conducted. All participants performed a series of tests, before which they had to fast. The order and schedule (8 am) of the tests was the same for the final-test and the same materials and procedures were used. A period of 30 consecutive days elapsed between the base-line and final tests, during which the participants had to ingest their supplement (placebo)."
15760049|NCT04776733|Other|prepackaged semisolid nutritional formulations|"The day before the colonoscopy: 3 bags of pre-packaged food were used for diet preparation.
~On the day of the colonoscopy: a bag of pre-packaged food were used for breakfast."
15760050|NCT04776733|Other|restricted diet|"The day before the colonoscopy: restricted diet prepared by patients were used for diet preparation.
~On the day of the colonoscopy: restricted diet prepared by patients were used for breakfast."
15760051|NCT04776720|Behavioral|Yoga Practice Program|3 month group yoga classes
15760052|NCT04776720|Behavioral|Physical Conditioning Program|3 month group physical conditioning classes
15760053|NCT04776694|Drug|Dupilumab|
15760054|NCT04776655|Drug|Bevacizumab|"This is the treatment assigned to experimental arm:
~All treatments will continue until disease progression, death, unacceptable toxicity, clinical decision or consent withdrawn."
15760055|NCT04776655|Drug|Cetuximab|"This is the treatment assigned to control arm:
~All treatments will continue until disease progression, death, unacceptable toxicity, clinical decision or consent withdrawn."
15760056|NCT04776655|Drug|5-FU|"FOLFIRI regimen: This is the treatment assigned to control and to experimental arms:
~All treatments will continue until disease progression, death, unacceptable toxicity, clinical decision or consent withdrawn."
15760057|NCT04776655|Drug|Irinotecan|"FOLFIRI regimen: This is the treatment assigned to control and to experimental arms:
~All treatments will continue until disease progression, death, unacceptable toxicity, clinical decision or consent withdrawn."
15760058|NCT04776655|Drug|Calcium levofolinate|"FOLFIRI regimen: This is the treatment assigned to control and to experimental arms:
~All treatments will continue until disease progression, death, unacceptable toxicity, clinical decision or consent withdrawn."
15760059|NCT04776642|Other|Biobank for Left atrial appendage tissue|Bodily material is used for biochemical marker assessments, histological and molecular analyses for research in cardiac arrhythmias.
15760060|NCT04776642|Other|Biobank for Blood|Bodily material is used for biochemical marker assessments, histological and molecular analyses for research in cardiac arrhythmias.
15760061|NCT04776642|Other|Biobank for One or more of following fat patches: epicardial fat, subcutaneous fat, pericardial fat, visceral fat.|Bodily material is used for biochemical marker assessments, histological and molecular analyses for research in cardiac arrhythmias.
15760062|NCT04776629|Drug|Orticumab|A human recombinant monoclonal antibody against a specific oxidized low-density lipoprotein (oxLDL) epitope
15760063|NCT04776629|Drug|Placebo|Placebo for orticumab, containing all components of formulation except the active ingredient
15760064|NCT04776616|Device|Exposure to white LED light|Participants will be exposed to white LED strip lights in a dark room for 2 hours a day
15760065|NCT04776616|Device|Exposure to green LED light|Participants will be exposed to green LED strip lights in a dark room for 2 hours a day
15760066|NCT04776590|Drug|Tislelizumab|neoadjuvant immunotherapy
15760067|NCT04776577|Device|Wirecath@ and Abbott PressureWire® (20 patients)|Simultaneous FFR measurements with Wirecath@ and Abbott PressureWire®
15760068|NCT04776577|Device|Wirecath® (20 patients)|FFR measurement with Wirecath® only
15760069|NCT04776577|Device|Coronary flow reserve|Pressure derived CFR with Wirecath®, Thermodilution CFR with Abbott PressureWire®, Absolut flow CFR with Abbott PressureWire® and Hexacath Rayflow catheter®, Non-invasive echo derived CFR
15760070|NCT04776564|Other|Participation in the couple enhancement program|Participation in a 12 hour long couple enhancement program called Gottman seven principles (G7P)
15760072|NCT04776538|Biological|Stem cells|Each participant will be double-blindly randomized to receive either adipose-derived allogeneic stem cells or placebo consisting of CryoStor10 (BiolifeSolutions), the freeze media for ASCs containing 10% Dimethyl sulfoxide (DMSO).
15760073|NCT04776538|Biological|Placebo|Each participant will be double-blindly randomized to receive either adipose-derived allogeneic stem cells or placebo consisting of CryoStor10 (BiolifeSolutions), the freeze media for ASCs containing 10% Dimethyl sulfoxide (DMSO).
15760074|NCT04776525|Drug|Ifosfamide|3 g/m2 each day for three days
15760075|NCT04776525|Drug|Doxorubicin|80 mg/m2 over four hours day 1
15760076|NCT04776512|Procedure|ESP Block With Bupivacain|bilateral lumbar ESP block using 0.375% Bupivacain
15760077|NCT04776512|Procedure|Epidural Analgesia|Continuous Lumbar Epidural analgesia With 0,125% Bupivacain+0,25 mcg/ml Sufentanil
15760078|NCT04776499|Drug|Propylthiouracil, Riociguat, Perphenazine|"Administration of propylthiouracil, riociguat, and perphenazine in combination
~Investigational medicinal product (IMP):
~Propylthiouracil: 100 mg, Riociguat: 1 mg, Perphenazine: 16 mg"
15760079|NCT04776486|Drug|Iohexol|"Intravenous injection of 5 ml of iohexol (Omnipaque) to calculate the glomerular filtration rate (area under the curve).
~Blood samples (2 ml) and urine (2 ml minimum) are to be collected for the determination of iohexol clearance at the following time points: pre-dose, 5 minutes, and 1, 2, 3, 4, 5, 6 hours post dose."
15760080|NCT04776473|Procedure|Open treatment|Open (i.e. surgical) treatment will be performed following the usual practice of the including centre adopting a pragmatic approach.
15760081|NCT04776473|Other|Closed treatment|Closed (i.e. conservative) treatment will be performed following the usual practice of the including centre adopting a pragmatic approach.
15760082|NCT04776447|Drug|Carboplatin|"Structure: The cis-diamino (cyclobutane-1, 1 dicarboxylate) plating. Stability: 24 hours at ambient temperature in 5% glucose, glucosamine or physiologic saline. It is recommended not to dilute with chlorinated solutions for this could affect the carboplatin.
~Route of administration: Intravenous infusion.
~Guidelines of Carboplatin administration: According to the standard of each center.
~Other Name: ATC code: L01XA02"
15760083|NCT04776447|Drug|Placlitaxel|"Structure: A diterpene whose composition is: 5b, 20-epoxy-1, 2a, 4,7b, 10b, 13a-hexahidroxytax-11-en 9 one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)- N-benzoyl-3-phenylisoserine.
~Stability: Concentrations of 0.3-1.2 mg/ml in 5% dextrose or normal saline have demonstrated chemical and physical stability for more than 27 hours at ambient temperature (25ºC approximately). The intact vial must be stored between 15º and 25ºC.
~Guidelines of Paclitaxel administration: Paclitaxel must be administered by infusion over 3 hours in dextrose (D5W) or normal saline (NS). The concentration must not exceed 1.2 mg/ml."
15760084|NCT04776447|Drug|Atezolizumab|"Atezolizumab is a humanized immunoglobulin (IgG1) monoclonal antibody that is produced in Chinese hamster ovary (CHO) cells. Atezolizumab targets programmed death-ligand 1 (PD-L1) on tumor-infiltrating immune cells (ICs) or tumor cells (TCs) and prevents interaction with the programmed death-1 (PD-1) receptor and B7.1 (CD80), both of which function as inhibitory receptors expressed on T cells and other immune cells.
~Patients will receive 1200 mg of atezolizumab administered by IV infusion every 21 days (+/- 3 days) in a monitored setting where there is immediate access to trained personnel and adequate equipment/medicine to manage potentially serious reactions."
15760085|NCT04776434|Device|SELUTION SLR™ (Sustained Limus Release) drug eluting balloon (DEB)|This study will capture data from the use of the SELUTION SLR according to its approved labelling.
15760086|NCT04776421|Procedure|Diverting ileostomy|Diverting ileostomy
15760087|NCT04776408|Device|Lung recruitment combined inhaled Nitric oxide|Ventilator combined inhaled Nitric oxide and Electrical Impedance Tomography monitor the V/Q mismatch
15760088|NCT04776408|Device|Lung recruitment|Ventilator and Electrical Impedance Tomography monitor the V/Q mismatch
15760089|NCT04776395|Drug|Dexamethasone|Given PO
15760090|NCT04776395|Drug|Iberdomide Hydrochloride|Given PO
15760091|NCT04776395|Other|Quality-of-Life Assessment|Ancillary studies
15760092|NCT04776382|Other|EMME (Eye Movement Modeling Examples)|Trainees of this group will watch an EMME (Eye Movement Modeling Examples)-recorded video, on where to focus their gaze while performing the epidural procedure in accordance with expert eye-tracking
15760093|NCT04776369|Drug|Lidocaine IV|single-bolus of lidocaine IV 4 mg/kg
15760094|NCT04776369|Drug|Magnesium Sulfate Injection|single-bolus of magnesium sulfate IV 30 mg / kg
15760095|NCT04776369|Drug|IV saline|Saline IV 50 ml
15760096|NCT04776356|Device|QuickFix Small Staple (Arthrex)|The Arthrex QuickFix Small Staple enables the surgeon to perform a wedge osteotomy of the first phalanx (Akin). The device is made of stainless steel and designed with barbed leg tips. The staple sizes are 8 and 10 mm wide with a 1 mm diameter.
15760097|NCT04776343|Other|telemedecine follow-up|weekly home-based follow-up of visual acuity on electronic tablet
15760098|NCT04776330|Biological|BCMA targeted prime CAR-T cells|BCMA targeted prime CAR-T cell therapy
15760099|NCT04776317|Biological|ChAdV68-S|Chimpanzee Adenovirus serotype 68 - Spike (ChAdV68-S) is a replication-defective, E1, E3 E4Orf2-4 deleted adenoviral vector based on chimpanzee adenovirus 68 (C68, 68/SAdV-25, originally designated as Pan 9), which belongs to the sub-group E adenovirus family. A single 0.5 mL intramuscular injection will be administered in the deltoid muscle. When possible, the prime vaccine and boost vaccine should be administered in different arms.
15760100|NCT04776317|Biological|ChAdV68-S-TCE|Chimpanzee Adenovirus 68 - Spike plus additional SARS-CoV-2 T cell epitopes (ChAdV68-S-TCE) is a replication-defective, E1, E3 E4Orf2-4 deleted adenoviral vector based on chimpanzee adenovirus 68 (C68, 68/SAdV-25, originally designated as Pan 9), which belongs to the sub-group E adenovirus family. A single 0.5- or 1.0-mL (depending on dose level) intramuscular injection will be administered in the deltoid muscle. When possible, the prime vaccine and boost vaccine should be administered in different arms.
15760101|NCT04776317|Biological|SAM-LNP-S|Self-Amplifying mRNA - Lipid Nanoparticles - Spike (SAM-LNP-S) is a SAM vector based on Venezuelan Equine Encephalitis Virus (VEEV). A single 0.25 mL or 0.5 mL (depending on dose level) intramuscular injection will be administered in the deltoid muscle. When possible, the prime vaccine and boost vaccine should be administered in different arms.
15760212|NCT04775420|Diagnostic Test|Measurement of mean platelet volume (MPV) and blood neutrophil to lymphocyte ratio (NLR)|MPV and NLR are easily accessible and inexpensive tests
15760213|NCT04775407|Procedure|blood sampling|IgM og IgG analysis
15760102|NCT04776317|Biological|SAM-LNP-S-TCE|Self-Amplifying mRNA - Lipid Nanoparticles -Spike plus additional SARS-CoV-2 T cell epitopes (SAM-S-TCE) is a SAM vector based on Venezuelan Equine Encephalitis Virus (VEEV). A single 0.25 or 0.5 mL (depending on dose level) intramuscular injection will be administered in the deltoid muscle. When possible, the prime vaccine and boost vaccine should be administered in different arms.
15760103|NCT04776317|Other|Sodium Chloride, 0.9%|The diluent used for this study will be 0.9% Sodium Chloride Injection, USP, and is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. Each milliliter (mL) contains sodium chloride 9 mg. It contains no bacteriostat, antimicrobial agent or added buffer and is supplied only in single-dose containers to dilute or dissolve drugs for injection. 0.308 mOsmol/mL (calc.). 0.9% Sodium Chloride Injection, USP contains no preservatives.
15760104|NCT04776304|Behavioral|Art Therapy|"This is a pilot study in which every participant receives the art therapy intervention arm. There are no waitlist or control arms. Art therapy is one promising intervention that helps service members (SMs) develop a visual voice, using imagery, symbolism, and metaphor to externalize emotions and experiences that they may not be able to express in words. The standardized, integrative mental health and human services approach of the art therapy program at the NICoE utilizes a mask-making directive to explore thoughts, feelings, and experiences of combat and self-understanding. This process is especially relevant to SMs with PTS symptoms who often remember their trauma as an incoherent, fragmented memory that is often predominantly sensory in nature. NICoE researchers have provided preliminary evidence suggesting associations between recurring art themes represented within the masks and individual BH symptoms."
15760105|NCT04776291|Radiation|4D PET-CT Scan|The recruited patients will have a 4d PET-CT scan that is additional to the usual care.
15760106|NCT04776278|Behavioral|Brief Alcohol Intervention (BAI)|This session includes a discussion related to harm reduction and the participant's autonomy to make decisions about the information provided in the session; an alcohol use decisional balance exercise; personalized alcohol-related feedback, and goal-setting. Elements included in the feedback are: (a) comparison of the participant's perception of how much he or she drinks and actual norms, (b) a comparison of the participant's alcohol consumption vs. norms, (c) an estimate of the participant's peak blood alcohol content in the past month, (d) alcohol-related problems experienced, (e) money spent on alcohol, and (f) calories consumed from alcohol. Participants discuss the personalized feedback with the clinician and review protective behavioral strategies if he or she indicates interest.
15760107|NCT04776278|Behavioral|Substance-free Activity Session (SFAS)|The SFAS session includes : a) discussion of life goals, b) discussion of associations between alcohol and drug use, goals, and substance-free activities; c) a graph depicting the participant's ratings of the relative importance of various aspects of their life and how their actions in the past week have been consistent with these priorities; d) personalized feedback on recent time allocation to activities across life domains, and a discussion of any changes the participant would like to make; e) feedback on symptoms of stress, anxiety and discussion of adaptive coping strategies; f) discussion of enjoyable substance-free activities and hobbies and substance-free recreational activity suggestions tailored to individual's interests and neighborhood; g) a goal setting exercise for specific behavior change plans; h) a Future Thinking Writing Exercise. Participants will receive weekly text-message based booster prompts for four weeks after their SFAS session.
15760108|NCT04776278|Behavioral|Relaxation Training (RT)|The clinician will begin by establishing the credibility of the session by providing the participant with the rationale that developing relaxation or mindfulness training strategies can reduce stress and enhance wellness. The clinician will then lead the participant through a diaphragmatic breathing exercise, followed by a progressive muscle RT protocol, and then a brief breath-counting (mindfulness) exercise. The session will conclude with a brief discussion of additional stress and anxiety management strategies (e.g., apps to monitor heartrate and breathing). Participants will be asked about their reaction to the techniques and, if interested, encouraged to commit to a specific plan for practicing these techniques.
15760109|NCT04776278|Other|Education Control|This condition will not include any clinical contact other than a brief (2-3 minute) discussion with the research assistant (RA) who completed the assessment session and who will describe the educational handout. This condition is meant to approximate a low-threshold public health-level approach to providing referral information and some of the content included in the BAI+SFAS condition but without any of the personalized information or MI/clinical contact. Thus, participants will receive information on risks associated with alcohol and drug misuse, strategies for reducing use/problems, and strategies for managing stress and setting and follow-through with achievable goals. The handout will also include links to hotlines, websites, and apps related to these domains. This condition will not include booster contact.
15760110|NCT04776265|Other|Evaluation of therapeutical approach after ASCT|Evaluation of therapeutical approach after ASCT
15760112|NCT04776239|Drug|100 million Allogeneic Mesenchymal Human Stem Cells|1 single intravenous infusion
15760113|NCT04776239|Other|Placebo|Placebo delivered via peripheral intravenous infusion
15760114|NCT04776226|Drug|Citalopram|Antidepressant use in patients with depression
15760115|NCT04776213|Drug|Mavenclad®|This extension study involves the follow up of participants who were enrolled in the parent study. The participants will be followed up for an additional 2 year period (until 4 years after initial administration of Mavenclad® tablets), during which the participants are not treated with Mavenclad®, as per European Medicines Agency (EMA) label of Mavenclad®.
15760116|NCT04776187|Drug|Gadodiamide|Gadodiamide Injection(OMNISCAN™)
15760117|NCT04776187|Drug|Gadoteric Acid Meglumine Salt|Gadoteric Acid Meglumine Salt Injection(Jia Di Xian™)
15760118|NCT04776174|Device|Ultrasound using the telerobotic Melody system|The children will first have a telerobotic ultrasound abdominal, pulmonary or cardiac followed by a classical ultrasound.
15760154|NCT04775901|Other|CT-guided lung biopsy|Percutaneous transthoracic lung biopsy was conducted stepwise under the real-time guidance of CT scan. This kind of modality served as an effective method for diagnosing peripheral lung lesions (all of the participants received fine-needle aspiration, some of them received coaxial needle biopsy as well, according to the pulmonologist's instruction).
15760214|NCT04775394|Other|Bronchoscopy|Bronchoalveolar lavage, mucosal biopsy and bronchial brushes during bronchoscopy
15760215|NCT04775381|Drug|Vitamin D|Patients will receive a cholecalciferol supplementation added to a fruit juice.
15760119|NCT04776161|Behavioral|Cue-Reward Intervention|"Patients in the first intervention arm will participate in a goal-setting exercise during which they will identify which habit they want to link their medication-taking to. Patients will also receive text messages reminding them of the habit they decided to link to their medication-taking.
~Finally, patients will also select a charity to which a donation will be made every time the bottle is opened. The research team will donate $0.50 every day that the patient takes their medication as prescribed. A research assistant will place a sticker with the charity logo under the pill bottle cap so that the patient is reminded of the donation every time they take the medication. Additionally, the patient will receive texts every 4 days summarizing how much money was donated on their behalf."
15760120|NCT04776161|Behavioral|Cue-Reward Intervention with possible intensification|"Patients in the second intervention arm will participate in a goal-setting exercise during which they will identify which habit they want to link their medication-taking to. Finally, patients will also select a charity to which a donation will be made every time the bottle is opened. The research team will donate $0.50 every day that the patient takes their medication as prescribed. A research assistant will place a sticker with the charity logo under the pill bottle cap so that the patient is reminded of the donation every time they take the medication. Additionally, the patient will receive texts every 4 days summarizing how much money was donated on their behalf.
~After 6 weeks, patients who demonstrate an adherence under 80% to study medications (as measured by the electronic pill bottle) will begin receiving text messages reminding them of their selected cue."
15760125|NCT04776135|Drug|MT-1186|Suspension
15760126|NCT04776122|Device|Therapy|Device-assisted breathing for relaxation
15760127|NCT04776122|Other|No device|Breathing platform without device
15760128|NCT04776109|Procedure|erector spinae block|"Bilateral erector spinae catheters will be placed at T8 level. a high frequency linear-array ultrasound transducer covered in a sterile sleeve will be placed in a longitudinal parasagittal orientation 3 cm lateral to the midline to identify the back muscles and the transverse Processes with shimmering pleura in between. Next, 2-3 ml of 2% lidocaine will be infiltrated .
~A 16-G, 8-cm Tuohy needle will be then introduced medially in the plane of the ultrasound beam and directed towards the transverse process. Once the needle is underneath the anterior fascia of the erector spinae muscle, 10 ml of saline 0.9% will be injected lifting the muscle of the transverse process. A catheter will be inserted into the newly formed space underneath the ES muscle and secured. The procedure will be repeated on the contralateral side. bupivacaine (20 ml of bupivacaine 0.25%) solution will be injected into each catheter"
15760129|NCT04776096|Drug|Bepotastine Besilate 1.5% PF|Bepotastine besilate 1,5% Preservative free ophthalmic solution
15760130|NCT04776096|Drug|Olopatadine Hydrochloride 0.2% BAK|Olopatadine hydrochloride 0.2% with BAK as preservative
15760131|NCT04776083|Drug|first line systemic therapy|first line systemic therapy according to the genetic mutation 0f the patient
15760132|NCT04776083|Radiation|3D radiotherapy or IMRT|Hypo-fractionated radiotherapy to the primary lesion
15760133|NCT04776057|Other|catarct surgery with toric intra ocular lenses|rotation stability of toric intraocular lenses between sitting or routine settings (sitting, going around) after cataract operation
15760134|NCT04776044|Drug|ATR-002|150mg tablets for oral intake
15760135|NCT04776044|Drug|Placebo|matching tablets for oral intake
15760136|NCT04776031|Device|R:GEN Laser System|Laser Treatment
15760137|NCT04776018|Drug|TAK-981|TAK-981 IV infusion.
15760138|NCT04776018|Drug|Mezagitamab|Mezagitamab SC injection.
15760139|NCT04776018|Drug|Daratumumab and Hyaluronidase-fihj|Daratumumab and Hyaluronidase-fihj SC injection.
15760140|NCT04776005|Other|Data collection|Assessment of the efficacy and immunogenicity of the anti-Sars-COv2 vaccines in patients treated for malignant pathology.
15760141|NCT04775992|Other|gabapentoids|Preemptive analgesia
15760142|NCT04775979|Drug|diphenylcyclopropenone (DPCP)|Depigmenting agent
15760143|NCT04775953|Drug|Cefazolin|Cefazolin is a semisynthetic cephalosporin analog with broad-spectrum antibiotic action due to inhibition of bacterial cell wall synthesis. Cefazolin (2 g will be administrated intravenously (IV) every 8 hours for 4-6 weeks)
15760144|NCT04775953|Drug|Dalbavancin|A second-generation lipoglycopeptide antibiotic synthesized from a fermentation product of Nonomuraea species
15760145|NCT04775953|Drug|Daptomycin|Daptomycin (USA) or Cubicin (Spain) is a cyclic lipopeptide antibiotic that inhibits gram-positive bacteria. Daptomycin (6-10 mg/kg will be administrated intravenously (IV) daily for 4-6 weeks
15760146|NCT04775953|Drug|Nafcillin|Nafcillin is a semi-synthetic antibiotic related to penicillin. Nafcillin (2 g will be administrated intravenously (IV) every 4 hours for 4-6 weeks)
15760147|NCT04775953|Drug|Oxacillin|Oxacillin is an antibiotic used in resistant staphylococci infections. Oxacillin (2 g will be administrated intravenously (IV) every 4 hours for 4-6 weeks
15760148|NCT04775953|Drug|Vancomycin|Vancomycin is a glycopeptide antibiotic product of the organism Amycolatopsis orientalis. Vancomycin (dose per local standard of care × 4-6 weeks)
15760149|NCT04775940|Procedure|Perforated collagen membrane|Horizontal Bone Augmentation using Perforated Collagen Membrane
15760150|NCT04775940|Procedure|Occlusive collagen membrane|Occlusive collagen membrane
15760151|NCT04775927|Other|education|premarital education
15760152|NCT04775914|Procedure|PCI + Ischemic conditioning|IPOST is repeated for 4 cycles (60 sec obstruction followed by 60 sec perfusion each) and followed by stent implantation with a 1.1/1.0 ratio of stent diameter/reference vessel diameter and a stent length sufficient to cover the entire lesion from healthy to healthy area of the vessel. During the first cycle of re-occlusion of full vessel occlusion is secured by a small injection of contrast.
15760153|NCT04775914|Procedure|Stent with ultrasound|IVUS catheters are to be advanced at least 20 mm distal to the culprit lesion. After administration of intracoronary nitroglycerine, an IVUS-pullback is to be performed at 0.5mm/second using a commercially available imaging system. Stent size and landing zones are decided based on the IVUS.
15760187|NCT04775602|Drug|18F-PSMA|18F-PSMA will be injected intravenously at a dosage of 200-250 megabecquerel (MBq) prior to perform Image acquisition (Topogram, CT, PET)
15760316|NCT04774393|Drug|Ivosidenib|Given PO
15760317|NCT04774393|Drug|Venetoclax|Given PO
15760155|NCT04775901|Device|Template-guided lung biopsy|A three-dimensional model consisting of participant's thoracic image information was initially reconstructed based on the CT scan data. Afterwards, a navigational template was customized, which accommodated well to the anatomical landmarks of the participant. The template was then printed by means of stereolithography from photopolymer material. Participants would receive navigational template-guided percutaneous transthoracic lung biopsy (all of the participants received fine-needle aspiration, some of them received coaxial needle biopsy as well, according to the pulmonologist's instruction).
15760156|NCT04775875|Device|Focused Ultrasound|The DWL Doppler ultrasound device enables visual and auditory wave form confirmation of cerebral arteries, and optical tracking technology (eg, AntNeuro Visor2 system) may be used in tandem with the Brainsonix Pulsar 1002 ultrasound device to track a patient's brain in virtual space as well as their physical location, thereby ensuring accurate placement.
15760157|NCT04775862|Drug|investigator choice re-challenge with anti EGFR Rx|Upon second progression, patients will be enrolled into the study as per inclusion criteria and consent, and a cfDNA blood test will be drawn, and RAS status will be examined. If RAS is wildtype, then the investigator will decide whether to re-challenge with an anti EGFR antibody , or give SOC third line chemotherapy (Regorafenib or TAS-102).
15760158|NCT04775849|Device|Femtosecond Laser|Femtosecond Laser assisted Cataract Surgery will be performed uni- or bilateral
15760159|NCT04775823|Procedure|Hybrid composite nano-ceramic|Indirect bonding the hybrid composite nano-ceramic restoration to the tooth to be restored of worn dentition patients
15760160|NCT04775810|Device|The device is an algorithm designed to enhance speech intelligibility of speech-in-noise signals|Normal-hearing and hearing-impaired subjects will listen to speech-in-noise audio files that are either unprocessed or processed in order to increase speech intelligibility.
15760161|NCT04775797|Drug|AB-836|Capsules or Tablets
15760162|NCT04775797|Drug|Placebo|Capsules or Tablets
15760163|NCT04775797|Drug|Tenofovir Disoproxil Fumarate|Tablets
15760164|NCT04775784|Diagnostic Test|Determination of SARS-CoV2 presence in CNS|Brain tissue sampling
15760165|NCT04775771|Behavioral|Animal Assisted Practice|The children, who were planned to be hospitalized for at least three days and were randomized to the experimental and control groups, were asked by the researcher using the face-to-face interview technique, and the questions in the patient information form were filled in on the form. Then, pre-test data were recorded by determining their anxiety levels with the State Anxiety Scale for Children, levels of fear with the Child Fear Scale, emotional and psychological well-being with the Stirling Children's Emotional and Psychological Well-being Scale. Unlike the other scales, the anxiety levels were assessed twice with one-hour intervals on the first day with the Children's State Anxiety Scale. On the third day, the anxiety levels were evaluated twice with one-hour intervals on the first day using the State Anxiety Scale for Children. The second group, the children in the control group, had the same procedure except for the intervention; but no intervention was made.
15760166|NCT04775758|Behavioral|Self-evaluating questionnaires|Patients are asked to describe their disease (gathering of anamnesis) and to categorize their symptoms according to their strength. Furthermore, patients complete self-evaluating questionnaires: Visual analog scale, Hospital anxiety and depression scale, Pittsburgh sleep quality index, Big five personality traits questionnaire.
15760167|NCT04775758|Behavioral|iMotions analysis platform|While patients' anamnesis and questionnaire indexes are being gathered, iMotions software will gather facial expression analysis, galvanic skin response and heart rate data which will be compared with self-evaluating questionnaires.
15760168|NCT04775745|Drug|LP-168|For the dose escalation phase, LP-168 will be given once or twice daily at the following dose levels:100 mg QD,150 mg QD, 100 mg BID, 300 mg QD, 150 mg BID, 450 mg QD, 225 mg BID, 600 mg QD, 800 mg QD, and 1000 mg QD.
15760169|NCT04775745|Drug|LP-168|For the dose expansion phase, subjects will receive once or twice daily dose of LP-168 at the Recommended Phase 2 Dose (RP2D). The RP2D may be as high as the MTD and will be determined following evaluation of Phase I Dose Escalation results.
15760170|NCT04775732|Biological|infliximab therapeutic drug monitoring|dose optimization of infliximab based on a predefined dosing algorithm
15760171|NCT04775719|Other|Patient-Specific Prediction of Functional Outcome|Information sheet that describes whether a patient is more likely to improve on or maintain their current preoperative function.
15760172|NCT04775719|Other|Standard Pre-Operative Total Knee Arthroplasty Information|Standard of care information that is routinely provided at patient preadmission appointments.
15760173|NCT04775706|Drug|HM15912 Active|Randomized, double-blind, placebo-controlled
15760174|NCT04775706|Drug|Placebo|Randomized, double-blind, placebo-controlled
15760175|NCT04775693|Device|RE (Robotic Exoskeleton)|Participants will continue to receive their prescribed standard of care physical therapy/gait training. They will also utilize the robotic exoskeleton twice a week during their inpatient stay and 3 times a week for 5 weeks as an outpatient (for outpatient, only if in the RE group). The Robotic Exoskeleton is a device that will be strapped to the chest and legs and worn over the shoulders like a backpack that will assist in walking. It uses sensors and participant motion to move. A licensed physical therapist will be assisting participants as they use the device.
15760176|NCT04775693|Other|SOC (standard of care)|Traditional physical therapist driven gait training.
15760177|NCT04775680|Biological|ADG106 injection|ADG106 injection, intravenous infusion, is administered as body weight every 3 weeks for 21 days as a cycle
15760178|NCT04775680|Biological|PD-1 antibody injection|PD-1 antibody injection is administered as an intravenous infusion and at a dose of 240mg every 3 weeks for 21 days as a cycle
15760179|NCT04775667|Other|questionnaires for clinical assessments|questionnaires for clinical assessments
15760180|NCT04775654|Dietary Supplement|Blackcurrant|Two capsules containing 455mg of CurrantCraft 11% black currant extract.
15760181|NCT04775654|Other|Placebo|Two capsules containing an inert material.
15760182|NCT04775641|Other|questionnaire|questionnaire
15760183|NCT04775628|Procedure|Inferior glide humerus in GH joint|Supine inferior glide GH joint
15760184|NCT04775615|Drug|DDO-3055 tablets；Placebo|Low dose：DDO-3055 tablets for 7 days or Placebo for 7 days
15760185|NCT04775615|Drug|DDO-3055 tablets；Placebo|Medium dose：DDO-3055 tablets for 7 days or Placebo for 7 days
15760186|NCT04775615|Drug|DDO-3055 tablets；Placebo|High dose：DDO-3055 tablets for 7 days or Placebo for 7 days
15760188|NCT04775589|Behavioral|Stepped Exercise for Knee Osteoarthritis|Patients start with a home-based exercise program, supported by an internet-based tool (Step 1). Patients are then assessed for degree of improvement in symptoms, and then can step up sequentially to telephone or video-based physical activity coaching (Step 2) and physical therapy (Step 3) if they do not make clinically relevant improvements in prior steps
15760189|NCT04775576|Other|Pleth Variability Index|Conventional fluid management is widely used in clinical practice. In this method, the fluid need of the patient is decided according to pulse, arterial blood pressure, central venous pressure, urine output and clinical condition. In the targeted fluid therapy method, besides static parameters such as pulse, arterial blood pressure, central venous pressure; Dynamic parameters such as Stroke volume variability (SVV), pulse pressure variability (PPV), pleth variability index (PVI), continuous hemoglobin (SpHb) are also used noninvasively.
15760190|NCT04775576|Other|Conventional fluid theraphy|8-10 ml / kg / hour iv fluid maintenance will be started for the control group. If the mean arterial pressure (MAP) is <65 mmHg or the decrease in MAP is more than 20%, 250 ml iv colloid will be applied. If the decrease in MAP continues despite the colloid bolus or if the MAP is below 65 mmHg, noradrenaline infusion will be started.
15760191|NCT04775576|Other|Anesthesia method|All patients included in the study will be premedicated with 1mg of midazolam after monitoring with pulse, non-invasive blood pressure, oxygen saturation. Then, invasive arterial cannulation will be applied and continuous blood pressure monitoring will be done. In the PVI group, non-invasive PVI and SpHb monitoring will also be performed from the other upper extremity without arterial cannulation. After two minutes of preoxygenation, anesthesia induction will be started. Anesthesia induction doses used routinely in our clinic include iv 2 mg / kg propofol, 0.6 mg / kg rocuronium and 2 μg / kg fentanyl. Sevoflurane will be administered by inhalation during anesthesia maintenance after tracheal intubation.
15760192|NCT04775563|Other|COVID-19 vaccine hesitancy scale in rheumatic diseases|The instrument was developed by Freeman et al, prior to its application, translation, cultural adaptation, and validation were performed.
15760193|NCT04775563|Other|COVID-19 vaccine hesitancy associated factors|The instrument includes questions about the doctor-patient relationship, perception of the COVID-19 vaccine, perception of risk of COVID-19 infection, perception of the severity of the pandemic in Mexico, perception of the severity of their rheumatic disease, perception of the control of comorbidities, perception of the intensity of the immunosuppressive treatment, positioning of the patient towards vaccines for COVID-19
15760198|NCT04775537|Device|OssiMend™ Bioactive Moldable|Lumbar Spine fusion with OssiMend™ Bioactive Moldable
15760199|NCT04775524|Behavioral|Storytelling Through Music (STM)|6 week expressive arts-based program
15760200|NCT04775524|Behavioral|Wait List / Storytelling Through Music-Hybrid|2 week song listening program
15760201|NCT04775511|Other|Heat Therapy with heating pads|20 minutes of heating pads will be applied to the medial gastrocnemius muscle, followed by gastrocnemius muscle stretching for 20 minutes. While the patient is lying in a prone position the towel, which is located between the skin and heating pads, and heating pads will be placed on the gastrocnemius muscle.
15760202|NCT04775511|Other|Cold Therapy with ice packs|20 minutes of ice packs will be applied to the medial gastrocnemius muscle, followed by gastrocnemius muscle stretching for 20 minutes. While the patient is lying in a prone position the towel, which is located between the skin and ice packs, and ice packs will be placed on the gastrocnemius muscle.
15760203|NCT04775511|Other|Stretching Exercises|20 minutes of stretching exercises will be applied. In stretching exercises, stretching will be done for 30 seconds. The stretching exercises, which contain the maximal tension to the ankle, will be performed by the same physiotherapist while the patient is in the supine position, hip and knee extension.
15760204|NCT04775498|Behavioral|Face-to-face psychoeducation group|All of the investigation centers participating in this study have a psychoeducation programme on bipolar disorders labeled and monitored by their Regional Health Agency. For this, he must respect the decree of January 14, 2015 relating to the specifications of therapeutic education programs for the patient. Patients will be receive by an investigator, for inclusion and baseline evaluation and at 6 and 12 months after inclusion. During this meeting, investigator and patient will be complete 7 questionnaires (about disease, treatment observance and quality of life), investigator will collect treatment, style life and adverse event(s).
15760205|NCT04775498|Behavioral|SIMPLe mobile application|The experimental intervention consists of 12 months use SIMPLe smartphone application who has been developed by the Barcelona Institute of neuroscience. The purpose of this application is to deliver individualized psychoeducation messages to the patient's clinical condition. The psychoeducational messages correspond to the contents of the different modules and sessions carried out in face-to-face psychoeducation groups (Colomm & Vieta ; 2015). Patients will be receive by an investigator for inclusion and baseline evaluation, at 6 and 12 months after inclusion. During this meeting, investigator and patient will be complete 7 questionnaires (about disease, treatment observance and quality of life), investigator will collect treatment, style life and adverse event(s).
15760206|NCT04775485|Drug|DAY101|DAY101 is an oral pan-RAF inhibitor provided as a white to off-white crystalline powder as an immediate-release tablet in 2 strengths, 20 mg and 100 mg.
15760207|NCT04775472|Procedure|Early left atrial septostomy within 12 hours after VA-ECMO implantation|Early left atrial septostomy group will routinely receive left atrial septostomy within 12 hours after VA-ECMO implantation. Left atrial septostomy will be done using percutaneous technique.
15760208|NCT04775472|Procedure|Selective left atrial septostomy|Left atrial septostomy will be done in cases of deleterious effect of increased LVEDP after VA-ECMO implantation, such as refractory pulmonary edema, abnormal opening of aortic valve, left ventricular dilatation, refractory ventricular tachycardia or fibrillation.
15760209|NCT04775459|Drug|Surfactant administration until 2020|Surfactant is administrated if Fi02 >30% among the Guidelines of 2019
15760210|NCT04775459|Drug|Surfactant administration since 2021|Surfactant is administrated if Fi02 >30% OR if score LUS >8/18 among the literature
15760211|NCT04775446|Other|Data collection|Data entered in a secure computer database
15760216|NCT04775368|Other|Administering diagnosis orientation questionnaires for the screening of possible sleep disorders|Several diagnosis orientation self-questionnaires will be conducted by the patient following his or her inclusion in order to detect, among other things, possible sleep disorders.
15760217|NCT04775355|Procedure|Biospecimen Collection|Undergo collection of stool and urine
15760218|NCT04775355|Other|Electronic Health Record Review|Medical records are reviewed
15760219|NCT04775355|Other|Quality-of-Life Assessment|Complete quality of life questionnaires
15760220|NCT04775355|Other|Questionnaire Administration|Complete questionnaires
15760221|NCT04775342|Device|smartphone|modern technology
15760222|NCT04775329|Drug|Rifaximin|Rifaximin 1000mg OM
15760223|NCT04775316|Device|Leukomed T / Tplus skin sensitive treatment|Application of sterile wound dressing.
15760224|NCT04775303|Drug|Cyclosporine 0.1% (Ikervis®) eye drop|One drop of Cyclosporine 0.1% (Ikervis®) eye drop once daily for 12 weeks
15760225|NCT04775290|Behavioral|Yoga lessons|2 weekly yoga classes during the 5 weeks of radiotherapy
15760226|NCT04775264|Procedure|pulsed electric field ablation|catheter ablation of ganglionated plexi structures on the epicardial surface of the heart during cardiothoracic surgery
15760227|NCT04775251|Other|Upward rotation exercise|Treatment for correction of depressed scapular Alignment by exercise ( Upward Rotation Exercises) for 6 weeks.
15760228|NCT04775238|Other|Silver nanoparticles|AgNPs (19±5 nm)
15760229|NCT04775238|Other|Copper nanoparticles|CuNPs (150-350 nm)
15760230|NCT04775225|Drug|Lidocaine|denervation of the obturator and femoral genicular branches by Lidocaine 2 %
15760231|NCT04775225|Drug|Placebo|an equivalent amount of saline will be injected subcutaneously in 2 points similar to the active group
15760232|NCT04775212|Drug|Desﬂurane|compare effects of inhaled anaesthetic desflurane and sevoflurane on liver functions.
15760233|NCT04775212|Drug|Sevoflurane|Sevoflurane
15760234|NCT04775199|Behavioral|Language Intervention|We will target vocabulary and grammar in the context of preschool science instructions.
15760235|NCT04775186|Procedure|Laparoscopic Burch colposuspension and Mid-urethral slings (TVT and TOT)|Laparoscopic Burch colposuspension and Mid-urethral slings (TVT and TOT)
15760236|NCT04775173|Drug|Sirolimus|Use of different doses of the same drug
15760237|NCT04775160|Device|SmartSafe|"The SmartSafe Ecological Momentary Intervention is contained in the MEmind smartphone application and consists of a Safety plan, an Enhanced contact via app (app-EC) intervention, and a mental toolbox. The Safety plan is a set of personalized coping strategies that the patient can use in a suicidal crisis. Our safety plan was adapted to a digital environment, including the possibility to activate pre-recorded messages, lead to websites with health resources, or put the patient in contact with the emergency services. The Enhanced contact via app (app-EC) intervention is inspired by the SIAM project and consists in messages that will be sent via the MEmind app inquiring patients about their mental well-being and informing them of the means to request preferential or urgent care. The mental toolbox contains videos relaxation techniques videos and behavioral activation and mentalization exercises."
15760238|NCT04775147|Other|Intensive BP lowering|The aim is to achieve a systolic BP level of <120mmHg within 1hour after successful recanalization and to maintain this BP level for the next 72 hours (or until hospital discharge or death of this should occur earlier)
15760239|NCT04775134|Diagnostic Test|Lung biopsy|Biopsy of residuary material from a medically indicated pulmonary resection
15760240|NCT04775121|Other|Deuterium Glucose|Oral administration of 20 g Deuterium Glucose on a 3-hour
15760241|NCT04775108|Device|Epygon™ Transcatheter Mitral Valve System|"The EPYGON VALVE is an innovative mitral valve, intended for valve replacement of a native mitral valve through a minimally invasive implant procedure by means of a dedicated implant device.
~The EPYGON VALVE is a bio prosthesis, composed by a functional assembly of bovine pericardium on a NiTinol stent."
15760244|NCT04775069|Biological|BNT162b2|Intramuscular injection
15760245|NCT04775069|Biological|CoronaVac|Intramuscular injection
15760246|NCT04775069|Biological|AZD1222|Intramuscular injection
15760247|NCT04775043|Diagnostic Test|HFRDIS questionnaire completion|HFRDIS Questionnaire (Hot Flash Related Daily Interference Scale) completion
15760248|NCT04775030|Drug|CBD occlusal appliance|Occlusal appliance manufactured with CBD molecules released from material to patients oral cavity during sleep time
15760249|NCT04775030|Device|Acrylic resin occlusal appliance|Acrylic resin occlusal appliance during sleep time
15760250|NCT04775004|Other|Bone marrow venting procedure (BMVP)|The BMVP involves creating small holes in a non-weight bearing area of the bone that does not have any important structures; the holes act as channels, which allow for flow of the participants own biologic products and stem cells from within the bone marrow.
15760251|NCT04775004|Other|Platelet Rich Plasma (PRP)|The PRP group will have 40cc to 60cc (about 3 tablespoons) of blood drawn at the time of surgery. The blood sample will then be prepared in a centrifuge machine to collect a component of the blood called platelet rich plasma. Once appropriate concentrations of the PRP are confirmed, the PRP will be injected into the subject's knee prior to wound closure.
15760252|NCT04774991|Drug|Azithromycin for Oral Suspension|"Azithromycin will be administered as a single dose in oral suspension form for children
~Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g) For children 1-11 months of age, weight-based dosing will be used For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program"
15760253|NCT04774978|Device|TTE|Transthoracic echocardiography
15760254|NCT04774965|Device|Slumber Curve sleep aid|Patients who undergo rotator cuff repair and have been consented and randomized to the experimental group will be given a Slumber Curve sleep aid to be used during sleep. Each device will be numbered and recorded in the patient's REDCap entry for future reference if needed. Following administration of the Slumber Curve, patients will be given instructions on how to use the sleep aid while sleeping, and will be asked to use Slumber Curve nightly.
15760255|NCT04774952|Drug|RMC-5552|RMC-5552 for IV administration
15760256|NCT04774939|Procedure|Endovenous laser ablation|The aim is to combine the significance of for sclerotherapy at the primary EVLA treatment
15760257|NCT04774926|Drug|Brolucizumab|120 mg/ml solution for intravitreal injection
15760258|NCT04774913|Procedure|Chronic total occlusion(CTO) percutaneous coronary intervention (PCI)|CTO PCI completed as a two step procedure with an initial planned CTO modification and a completion procedure after 8-12 weeks
15760259|NCT04774900|Procedure|Administration of oxygen|Administration of high-flow oxygen via face mask to a high fidelity mannequin.
15760260|NCT04774900|Procedure|Administration of drug in a nebulizer|Administration of bronchodilator via nebulizer mask to a high fidelity mannequin.
15760261|NCT04774900|Procedure|Securing intravenous line|Securing an intravenous line at the forearm of high fidelity mannequin.
15760262|NCT04774900|Procedure|Administration of IV drug|Administration of bronchodilator via IV line to a high fidelity mannequin.
15760263|NCT04774900|Procedure|Needle decompression of tension pneumothorax|Needle decompression of tension pneumothorax on a high fidelity mannequin.
15760264|NCT04774887|Biological|HPV vaccine, Merck|We will offer vaccination against HPV to 900 children/grandchildren aged 9 through 18 of women attending the Community Meetings.
15760265|NCT04774874|Drug|Topical formulation|Topical administration on the scalp once daily for 16 weeks
15760266|NCT04774848|Device|High Frequency Jet Ventilator|HFJV provides short bursts of gas into the respiratory circuit at a rate of 240 to 600/min (4 to 11 Hz) and expiration is passive. It is used in conjunction with a conventional ventilator which provides positive end expiratory pressure (PEEP) and can also provide occasional sigh breaths.
15760267|NCT04774848|Device|High Frequency Oscillatory Ventilator|HFOV uses a piston diaphragm to generate alternating positive and negative pressure changes to give breaths of 300 to 900/min (5-15 Hz) given over a set mean airway pressure. Both inhalation and exhalation are active.
15760268|NCT04774835|Diagnostic Test|HIVST|aPS will be offered to sexually active men and women who test HIV seropositive at the study sites by facility staff supported by aPS advisors. Those accepting aPS will be asked to provide names and contact information (phone numbers; home and work addresses) for their sexual partners, and these partners will be contacted, notified anonymously of the HIV exposure, and offered HIV self-testing by HTS counselors working at the facilities. Any partner who tests HIV seropositive will receive assistance linking to care and registering in an HIV comprehensive care clinic. They will also receive aPS so that their partners can be notified and HIV tested. Follow-up of index clients will continue after testing through HTS locations and all partners will be followed to determine HIV testing and treatment outcomes.
15760269|NCT04774835|Diagnostic Test|Standard aPS|aPS will be offered to sexually active men and women who test HIV seropositive at the study sites by facility staff supported by aPS advisors. Those accepting aPS will be asked to provide names and contact information (phone numbers; home and work addresses) for their sexual partners, and these partners will be contacted, notified anonymously of the HIV exposure, and offered HIV testing at their local HTS location by HTS counselors working at the facilities. Any partner who tests HIV seropositive will receive assistance linking to care and registering in an HIV comprehensive care clinic. They will also receive aPS so that their partners can be notified and HIV tested. Follow-up of index clients will continue after testing through HTS locations and all partners will be followed to determine HIV testing and treatment outcomes.
15760270|NCT04774822|Procedure|Color Fundus Photography|Stereoscopic Fundus photography
15760271|NCT04774822|Drug|Mydriatics Agent|Eye dilating agent
15760272|NCT04774822|Procedure|Optical Coherence Tomography (OCT)|Optical Tomographic imaging of retina
15760273|NCT04774809|Drug|Low Dose SHR0302 Ointment BID|Low Dose SHR0302 Ointment BID
15760274|NCT04774809|Drug|High Dose SHR0302 Ointment BID|High Dose SHR0302 Ointment BID
15760275|NCT04774809|Other|Placebo Comparator: Vehicle|Placebo
15760276|NCT04774796|Other|Cognitive Behavioural Therapy|Participants will take part in a one day, or two half-day group CBT workshop for parents of children with food allergy. The workshop will included understanding difficulties using a CBT model, psychoeducation on common psychological issues (e.g. anxiety) and the development of skills to help deal with maladaptive cognitions and behaviours relating to managing a child's food allergy.
15760277|NCT04774783|Device|Low-Level Laser Therapy|The TheraTouch LX2 device includes a 9-diode cluster probe which emits a combination of LED and laser light. The cluster probe includes four 650 nm LED diodes capable of delivering a total of 40 mW and five 850 nm laser diodes capable of delivering a total of 1000 mW of power. LLLT will the applied with the cluster probe directly in contact with the subject's skin. LLLT dosages will vary according to the location of the subject's pain and may require multiple applications during a session. Each individual application will typically range from 4-16 Joules.
15760278|NCT04774770|Behavioral|HED-Start|The HED-Start Program is a cognitive-behavioral intervention based on self-management and motivational interviewing principles.
15760279|NCT04774757|Procedure|Para-aortic lymph node dissection|Para-aortic lymph node dissection was defined as the dissection of para-aortic lymph nodes located below renal vein and above the bifurcation of iliac artery.
15760280|NCT04774744|Other|Educational Intervention|Receive digital health coaching program
15760281|NCT04774744|Other|Questionnaire Administration|Ancillary studies
15760282|NCT04774744|Other|Supportive Care|Receive standard of care support services
15760283|NCT04774731|Other|Whole Body Vibration|Receiving WBV training three times a week before initiation of dialysis sessions for 12 weeks. Subjects stand on a platform of WBV for 3 minutes in every training session.
15760285|NCT04774705|Other|SNV activ group (Non-invasive transcutaneous stimulation of the vagus nerve )|A transcutaneous stimulator of the atrial branch of the vagus nerve of the TENS eco Plus type (Schwa-medico) will be used. SNV stimulation will be applied in the concha of the left ear to the subcutaneous area of the atrial branch of the vagus nerve in the left ear (cymba conchae) for each patient, at an intensity of 2 mA, 30 minutes per day for 5 consecutive days, from the day of inclusion / randomization.
15760286|NCT04774705|Other|Placebo group|For the control group, the stimulation electrode will be inverted so as to deliver the stimulation to the ear lobule.
15760287|NCT04774679|Procedure|Endosonographic fine needle aspiration biopsy|An endoscopic ultrasound device will be inserted to the stomach and biopsy will performed with a needle
15760288|NCT04774666|Behavioral|Acceptability of OraQuick Advance© Rapid HIV-1/2 Antibody screening|Oral fluid-based HIV test
15760289|NCT04774653|Other|No intervention|Associations and prevalence will be calculated
15760290|NCT04774640|Device|MaterniT GENOME|
15760291|NCT04774627|Drug|PARP inhibitor|All patients treated at least with 1 PARPi
15760292|NCT04774614|Procedure|anterior laminate veneers|VITA ENAMIC multiColor
15760293|NCT04774588|Other|VSI streamer and Microsoft Hololens 2 classed as a Class III device by Health Canada.|1.1 Description of VSI streamer device and software The VSI Streamer is a box that can be connected to ultrasound, endoscope, microscope, laparoscope and other devices via HDMI connection. The view of the imaging devices, which is conventionally displayed on a monitor, is transmitted wirelessly and in real time to the Mixed Reality HoloLens 2 (Microsoft Inc.) and appears as a virtual monitor that can be flexibly moved and positioned in space. Since this is Mixed Reality, the real environment remains visible. If required, several virtual monitors can be streamed into the Mixed Reality glasses at the same time
15760295|NCT04774562|Behavioral|Video-Assisted Discharge Education (VADE)|Video-Assisted Discharge Education (VADE): Information about THR, preventive rehabilitation approaches, transfer activities, using stairs, self-care activities.
15760296|NCT04774562|Behavioral|Physiotherapy (PT) Program|Physiotherapy (PT): Breathing exercises, positioning, hip range of motion and strengthening exercises, and information about walking and ambulation.
15760297|NCT04774536|Drug|CRISPR_SCD001|CRISPR_SCD001 is administered by IV infusion following myeloablative conditioning with busulfan.
15760302|NCT04774510|Other|Diagnostic Test: optimized C-Arm Cone Beam Computed Tomography|Optimized C-ARM CBCT using new geometry and a novel software can rapidly and accurately detected brain abnormalities and hemorrhagic complications for critical patients with acute stroke. This rapid assessment would eliminate the need for the patient to be imaged in another scanner and be subsequently transported again to another room; all anatomic and physiologic imaging would occur in the neuro angiography suite (NAS).
15760306|NCT04774471|Diagnostic Test|Evaluation of BIT-Motion software|Software program to discern benign versus malignant breast lesions.
15760307|NCT04774458|Procedure|Fluoroscopic-guided cervical epidural access|After identifying the target level of the cervical spine under a fluoroscopy-guided anteroposterior image, an 18-Tuohy needle is inserted through a paramedian approach after local infiltration with 1% lidocaine. When feeling a strong resistance through the needle by a ligamentum flavum, the image intensifier is rotated to 50 degrees contralateral oblique (CLO) direction. After then, the needle is advanced to just before the ventral interlaminar line in CLO view. It is subsequently advanced further until it is in the epidural space using a LOR-to-air technique. Correct epidural access is confirmed by the injection of contrast medium. After identifying epidural space in AP and CLO view without abnormal dispersion of contrast,(vascular uptake, intrathecal spreads, etc.), a 3-4ml mixture of 0.5% lidocaine with dexamethasone 5mg is injected.
15760308|NCT04774445|Behavioral|MyCancerGene|Interactive Health Communication Application
15760309|NCT04774432|Other|GM-CSF group|GM-CSF added to CAPA and maturation medium
15760310|NCT04774432|Other|Control group|GM-CSF will not be added to CAPA and maturation medium
15760311|NCT04774419|Radiation|Intensity modulated radiation therapy (IMRT)|To the pelvic nodes and vaginal cuff (total dose of 45-50.4Gy at 1.8 Gy per fraction) for 5-6 weeks.
15760312|NCT04774419|Drug|TSR-042|IV TSR-042 every 3 weeks for 4 cycles followed by 1 dose of 1000mg (C5). Patients will receive a maximum of 5 cycles of TSR-042.
15760313|NCT04774406|Drug|olaparib, rucaparib, niraparib, talazoparib, veliparib, pamiparib|All patients treated at least with 1 PARPi (alone or in combination)
15760314|NCT04774393|Drug|Decitabine and Cedazuridine|Given PO
15760315|NCT04774393|Drug|Enasidenib|Given PO
15760318|NCT04774380|Drug|Durvalumab|Participants will receive durvalumab via IV infusion on Day 1 of each cycle.
15760319|NCT04774380|Drug|Cisplatin|Participants will receive cisplatin via IV administration on Day 1 of each cycle.
15760320|NCT04774380|Drug|Carboplatin|Participants will receive carboplatin via IV administration Day 1 of each cycle..
15760321|NCT04774380|Drug|Etoposide|Participants will receive etoposide via IV administration on days 1 to 3 of each cycle.
15760322|NCT04774367|Device|Order of forceps : First standard biopsy forceps and second large capacity biopsy forceps|Order of forceps : First standard biopsy forceps and second large capacity biopsy forceps
15760323|NCT04774367|Device|Order of forceps : First large capacity biopsy forceps and second standard biopsy forceps|Order of forceps : First standard biopsy forceps and second large capacity biopsy forceps
15760324|NCT04774354|Diagnostic Test|POSSUM|These scales will be calculated and compared to the outcomes obtained in our center.
15760325|NCT04774341|Drug|anticoagulation treatment|Adherence to personalized evidence-based anticoagulant treatment in patients at high risk for stroke with atrial fibrillation
15760326|NCT04774328|Drug|CA-008 (vocacapsaicin)|Single administration of CA-008 (vocacapsaicin) versus placebo
15760327|NCT04774328|Drug|Placebo|Single administration of CA-008 (vocacapsaicin) versus placebo
15760328|NCT04774315|Drug|Omalizumab|omalizumab 300mg SQ every 4 weeks as part of standard of care
15760329|NCT04774276|Other|cardiac rehabilitation protocol without occupational therapist|cardiac rehabilitation protocol without occupational therapist will be performed (usual practice before January 2021).
15760330|NCT04774276|Other|cardiac rehabilitation protocol with occupational therapist|"This intervention (occupational therapist) have been added since 2021 for all patients who need a cardiac rehabilitation protocol.
~Occupational therapy is scheduled with sessions 3 times a week for 1 month."
15760331|NCT04774263|Other|Individual interviews|Discussion between the searcher and the participant about representations and acceptability about a potential real time localization system
15760332|NCT04774250|Drug|Zonisamide 100Mg Cap|ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide.
15760333|NCT04774250|Drug|Placebo|The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule.
15760337|NCT04774224|Drug|Baricitinib|Participants will take one tablet of study drug per day for 48 weeks, and will be followed up for 48 weeks after study drug treatment has finished. Two-thirds of participants will receive Baricitinib.
15760338|NCT04774224|Drug|Placebo|Participants will take one tablet of study drug per day for 48 weeks, and will be followed up for 48 weeks after study drug treatment has finished. One-third of participants will receive Placebo.
15760339|NCT04774211|Diagnostic Test|SOS-PD|Validation of SOS-PD bedside assessments comparing the Danish SOS-PD scale with a Child Psychiatrist using DSM-V as the reference standard
15760340|NCT04774198|Diagnostic Test|blood sample|Blood samples are collected within 24 hours before the surgical procedure, on postoperative day two and seven. Samples collected are as following: TruCulture, flow cytometry, markers of systemic inflammation (Plasma level of pro- and anti-inflammatory molecules assed by Olink inflammation panel, leucocytes, differential count, hemoglobin, thrombocytes and CRP)
15760341|NCT04774185|Device|New hearing aid loudspeaker|The new hearing aid loudspeaker will be fitted to the participants individual ear anatomy and hearing loss.
15760342|NCT04774185|Device|Standard hearing aid loudspeaker|The standard hearing aid loudspeaker will be fitted to the participants individual ear anatomy and hearing loss.
15760343|NCT04774159|Drug|Colchicine 0.5 MG Oral Tablet|"Colchicine 0.5 mg tablet daily
~Active drug and placebo are of the same appearance and are indistinguishable. All investigators, study personnel and patients will be blinded to drug treatment assignment. Trial treatment supplies must be stored in a secure, limited-access location under the storage conditions specified on the IP supply label."
15760344|NCT04774159|Drug|Colchicine-Placebo|Colchicine-Placebo tablet
15760346|NCT04774133|Diagnostic Test|Blood sample|Pazients will undergo to blood samples at predefined times
15760347|NCT04774120|Drug|Propofol|Propofol will be started at a rate of 15-20 mg/kg/hr in patients >65 years and 20-25 mg/kg/hr in younger patients (<65 years) until a suppression rate (SR) is achieved. If not, can be increased by 5 mg/kg/hr every 5 minutes up to 25 mg/kg/hr in the elderly group and 30 mg/kg/hr in the younger group or after 15 minutes have passed. When the SR appears, propofol infusion will be stopped. Then restarted at half of the initial rate. Maintenance of anesthesia will be guided by Sedline Monitor to maintain an alpha band present in the spectrogram and SEF95 between 8-12 Hz. BIS monitor will be covered. Both EEG signals (Sedline and BIS) will be registered simultaneously until the patient's extubation.
15760348|NCT04774107|Drug|P1101 + Ribavirin|P1101 400 µg SC
15760350|NCT04774081|Device|24h Continuous glucose monitoring and urinary C-peptide collection|Participants will be admitted to the research clinic for a 24-hour stay in a metabolic chamber. During the chamber stay, all urine excreted will be collected to assess C-peptide urinary excretion rate and interstitial glucose will be measured by a continuous glucose monitor (CGM). Participants will consume a eucaloric diet (50% carbohydrates, 30% fat and 20% protein).
15760351|NCT04774068|Drug|Parsaclisib|Given PO
15760352|NCT04774068|Drug|Romidepsin|Given IV
15760353|NCT04774042|Dietary Supplement|Infloran probiotic|Infloran
15760354|NCT04774042|Dietary Supplement|HAC probiotic|HAc probiotic
15760355|NCT04774042|Dietary Supplement|Infloran placebo|Infloran placebo
15760356|NCT04774042|Dietary Supplement|HAC placebo|HAC placebo
15760357|NCT04774029|Procedure|Basivertebral nerve block|Temporary intraosseous basivertebral nerve block using lidocaine
15760358|NCT04774029|Drug|Lidocaine induced basivertebral nerve block|Intraosseous lidocaine basivertebral nerve block
15760359|NCT04774016|Other|Test formula A without added pre- and pro-biotic|An identical formula as test formulas fortified with 2.20 mg iron as FeSO4-58 and 0.05 mg native iron per serving (235 ml), but without added pre- or probiotic.
15760360|NCT04774016|Other|Test formula B with synbiotic|Test formula fortified with 2.20 mg iron as FeSO4-57 and 0.05 mg native iron per serving (235 ml) and added synbiotic.
15760361|NCT04774016|Other|Test formula C with HMOs|Test formula fortified with 2.20 mg iron as FeSO4-54 and 0.05 mg native iron per serving (235 ml) and added HMOs.
15760362|NCT04774003|Drug|100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran)|100 mg inclisiran sodium (equivalent to 94.5 mg inclisiran) in 0.5 mL solution. Subcutaneous administration at Day 1
15760363|NCT04774003|Drug|Placebo|Inclisiran sodium 0mg (equivalent to inclisiran 0 mg) in 1.5 mL solution. Subcutaneous administration at Day 1
15760364|NCT04774003|Drug|300 mg inclisiran sodium (equivalent to 284 mg inclisiran)|300 mg inclisiran sodium (equivalent to 284 mg inclisiran) in 1.5 mL solution. Subcutaneous administration at Day 1
15760365|NCT04773990|Device|Biodex Balance System|Subjects will receive several unique training modules using biodex
15760366|NCT04773990|Other|specific physical therapy exercise program|Subjects will receive recommended PT program
15760367|NCT04773977|Drug|IBI362 liquid formulation|Administered by subcutaneous injection
15760368|NCT04773977|Drug|IBI362 lyophilized powder|Administered by subcutaneous injection
15760369|NCT04773964|Drug|MET642|MET642 active treatment
15760370|NCT04773964|Drug|Placebo|Placebo comparator
15760371|NCT04773951|Biological|JS004, a recombinant humanized, IgG4κ monoclonal antibody (mAb) specific to B- and T-lymphocyte attenuator (BTLA); Toripalimab Injection|Biological: JS004, Intravenous infusion; Toripalimab Injection, Intravenous infusion
15760372|NCT04773925|Behavioral|Mindfulness counseling|Subjects three 60-minute mindfulness counseling sessions with a certified Mind-Body Counselor who has a degree in Social Work in the department of Integrative Medicine. The mindfulness sessions will be conducted entirely via telemedicine. The initial consultation will consist of a 60-minute individual session. The next session will be a group visit (plan for 5 subjects per group) lasting 60 minutes, which will be scheduled for 2 weeks after the initial session. The third session will be another 60-minute group session, which will be scheduled for 6 weeks after the initial session.
15760373|NCT04773899|Diagnostic Test|Procedure : Multimodal microvascular assessment at study inclusion|"Vascular occlusion test (VOT) performed on the arm. Measurement of the quality of tissue reperfusion by NIRS on the thenar eminence and the digital perfusion index.
~Microcirculation reactivity is measured for each patient with a laser speckle contrast imaging (LSCI) placed on the forearm. Tests will be performed for evaluation of microvascular reactivity: Acetylcholine and Nitroprusside Iontophoresis.
~Morphological analysis of the microcirculation by sublingual videomicroscopy."
15760374|NCT04773886|Drug|Mineral trioxide aggregate|Vital Pulpotomy will be done using Mineral trioxide aggregate (MTA) as pulp capping agent
15760375|NCT04773886|Drug|Biodentine|Vital Pulpotomy will be done using Biodentine as pulp capping agent
15760376|NCT04773886|Biological|Platelet rich fibrin|"10 ml of blood was drawn from the peripheral vein in the selected patients with the help of sterilized disposable syringe and blood was collected in the pre-sterilized borosilicate glass test tube, without any addition of anticoagulant and was immediately centrifuged at 3000 rpm for 15 minutes in a centrifuge unit.
~The product obtained after centrifugation consisted of three layers:
~Acellular platelet plasma- top most layer
~Platelet rich fibrin -middle layer
~Red blood corpuscles- bottom layer PRF was then separated from the red blood corpuscles base with the help of sterile tweezers and scissors and squeezed with the help of sterile gauze piece"
15760377|NCT04773873|Device|PFM Crowns on gold coping cast-on|Classic impressions are taken by the operators and sent to one and same laboratory who will deliver all the screw-retained PFM restorations. The crowns will be made using a gold coping cast-on synOcta gold abutment (Ceramicor) for wide (WN) or regular (RN) neck
15760378|NCT04773873|Device|hybrid abutment lithium disilicate crown|Intraoral digital impression with respective scanbodies (Sirona) for Cerec OmniCam or Cerec Bluecam over the chosen TiBase. Cerec CAD designing (operator) and CAM milling (Cerec MCXL) of single crowns with perforated blocs (e.max CAD). crystallization/ characterization/ glaze firing for the e.max CAD crown using an oven with specific firing programmes for e.max CAD. Adhesive cementation steps of the ceramic crown onto the TiBase
15760379|NCT04773873|Device|hybrid abutment ceramic polymer infiltrated crown|Intraoral digital impression with respective scanbodies (Sirona) for Cerec OmniCam or Cerec Bluecam over the chosen TiBase. Cerec CAD designing (operator) and CAM milling (Cerec MCXL) of single crowns with perforated blocs (Enamic). Surface polishing with rubber polishers. Adhesive cementation steps of the ceramic crown onto the TiBase
15760380|NCT04773860|Other|Muscle Energy Techniques|A 4 week intervention will be carried out consisting of Muscle Energy Techniques on the accessory muscle of respiration. That is, Pectoralis Minor, Sternocleidomastoid, Upper trapezius, Scalene muscles and Latissimus Dorsi
15760381|NCT04773847|Procedure|Surgical reconstruction of maxillofacial osseous defect with MimetikOss 3D.|Surgical reconstruction of maxillofacial osseous defect with MimetikOss 3D.
15760384|NCT04773821|Other|Targeted biopsies|Prostate MpMRI at 12 month (after PCa focal treatment in standard care) and targeted biopsies in the presence of lesion(s) suggestive(s) of recurrence
15760385|NCT04773795|Device|EndoZip System|"The Nitinotes EndoZip system is designed to allow for the creation of multiple internal gastric segmentation (4-8) in the stomach by using an endoscopic approach. The system allows the forming of wall-to-wall longitudinal attachments of the anterior and posterior stomach walls, creating multiple strictures within.
~Creation of this segmentation may significantly reduce gastric volume, may affect gastric motility and consequently, reduce weight."
15760386|NCT04773782|Drug|avapritinib|oral administration
15760452|NCT04773236|Drug|sodium bicarbonate 8.4%|mixing the sodium bicarbonate with 2%lidocaine and 1:80.000 epinphrine using mixing pen (onset buffering system)
15760387|NCT04773769|Dietary Supplement|Tea Made of Graviola Leaves|"Graviola leaves will be supplied to the patient with instructions on how to prepare the tea which will consist of 10 guanabana leaves which the patient will boil in 1 liter of water for 3 minutes. Once boiled, the formulation will be stores in the refrigerator and once cool enough the patient will start drinking 100 cc two times per day.
~The Treatment Period begins with Cycle 1 Day 1 dosing. Patients will take the tea continuously during a 28-day cycles, until there is an indication for treatment change based on response assessment."
15760388|NCT04773756|Drug|Sofosbuvir 400 MG/ Daclatasvir 60mg|Giving these two drugs for treatment of COVID patients
15760389|NCT04773743|Other|Yoga|Remotely delivered yoga intervention
15760390|NCT04773730|Procedure|Posterior transversus abdominus plane block|Twenty mL of bupivacaine 0.25% will be injected in the plane between the transverses abdominus muscle and the fascia deep to the internal oblique muscle on each side
15760391|NCT04773730|Procedure|Quadratus lumborum block type 2|Twenty mL of bupivacaine 0.25% will be injected on the posterior surface of quadrates lumborum muscle on each side
15760392|NCT04773717|Drug|Ascorbic acid|200mg/kg/24h in four equal parts
15760393|NCT04773717|Drug|Placebo|The same regimen as ascorbic acid.
15760394|NCT04773704|Diagnostic Test|FILMARRAY® Pneumonia Plus Panel technique|FILMARRAY® Pneumonia Plus Panel technique (multiplex PCR) on a respiratory sample
15760395|NCT04773691|Device|Active rTMS|"Two rTMS stimulation sessions spaced 15 minutes apart are delivered daily for 5 consecutive days.
~A total of 10 sessions. Stimulation parameters: 10 Hz, 1000 pulses per session, 110% of SM, cortical target: right DLPFC"
15760396|NCT04773691|Device|Placebo rTMS|"Two rTMS stimulation sessions spaced 15 minutes apart are delivered daily for 5 consecutive days.
~A total of 10 sessions. Stimulation parameters: delivering a non-significant current at the beginning and end of the stimulation, simulating active stimulation."
15760397|NCT04773691|Other|Questionnaires|questionnaires for craving assessment: EVA, OCDS, CGI and ADS and signs of physical withdrawal by CIWA
15760398|NCT04773691|Device|Breathalyzer|estimation of blood alcohol level
15760399|NCT04773678|Drug|CBP-201|CBP-201 subcutaneous (SC) injection.
15760400|NCT04773678|Drug|Placebo|Placebo subcutaneous (SC) injection.
15760401|NCT04773665|Biological|VBI-2902a|VBI-2902a is an intramuscular injection of VBI-2902a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
15760402|NCT04773665|Biological|Placebo|0.9% sodium chloride
15760403|NCT04773665|Biological|VBI-2905a|VBI-2905a is an intramuscular injection of VBI-2905a investigational enveloped virus-like particle COVID-19 vaccine with aluminum phosphate adjuvant.
15760404|NCT04773652|Diagnostic Test|speckle tracking echo|Two-dimensional and 3D Speckle tracking echocardiography and feature tracking CMR will be performed twice: within 48 hours of admission and 3 months following the index event.
15760405|NCT04773639|Behavioral|Multi-Modal Palliative Care Intervention|An innovative muli-modal palliative care intervention that addresses the lack of advance care planning and unmet psychosocial needs commonly experienced by patients with metastatic cancer.
15760406|NCT04773639|Behavioral|Usual Care Control Condition|The control condition includes usual care (UC) at the collaborating clinics, consisting of access to a clinical social worker and nurse practitioners for advance care planning and supportive visits at patient request.
15760407|NCT04773613|Other|Experimental SLP|SLP was given to the infant during bottle-feeding.
15760408|NCT04773613|Other|Experimental SEP|SEP was given to the infant during bottle-feeding.
15760409|NCT04773600|Drug|ARQ-151 Active|ARQ-151 Cream 0.15% - Active
15760410|NCT04773600|Drug|ARQ-151 Vehicle Cream|ARQ-151 Cream - Vehicle
15760411|NCT04773587|Drug|ARQ-151 Active|ARQ-151 Cream 0.15% - Active
15760412|NCT04773587|Drug|ARQ-151 Vehicle|ARQ-151 Cream - Vehicle
15760413|NCT04773574|Device|Corneal topography, Optical coherence tomography (OCT) and Optical coherence tomography angiography (OCTA)|"Ocular investigations were performed in each trimesters and at 6 weeks after childbirth.
~st trimester : gestational age 8-12 weeks
~nd trimester : gestational age 24-28 weeks
~rd trimester : gestational age 34-38 weeks"
15760414|NCT04773561|Device|Corneal tomography, optical coherence tomography and optical coherence tomography angiography|Ocular investigations were performed in one time during 30-36 weeks of gestational age. Due to avoidance of diurnal variation, all examinations were done between 10 am - 12 pm.
15760415|NCT04773548|Other|VR-JIT|Job interview with virtual interviewer
15760416|NCT04773535|Device|3D Motion analysis|Motion analysis using DyCare® Lynx system with inertial based sensors as well as an optoelectronic motion analysis system based on infrared cameras (11x Vicon infrared high speed cameras)
15760417|NCT04773522|Drug|Talquetamab|Talquetamab will be administered subcutaneously.
15760418|NCT04773509|Procedure|Paravertebral block|Randomly selected patients of the PVB group are performed PVB with 0.2% ropivacaine on both sides.
15760419|NCT04773496|Diagnostic Test|instrumental description of the subject's center of gravity (COG) sway|qualitative and quantitative analysis of the balance function through the description of the center of gravity (COG) sway
15760420|NCT04773483|Dietary Supplement|Quorn Foods products|180 g mycoprotein (wet weight; corresponding to 45 g dry weight) per day (equates to approx. 215 g Quorn Foods products, depending on the product)
15760421|NCT04773483|Dietary Supplement|Meat/fish products|Standard meat/fish products matched to Quorn group for protein intake
15760422|NCT04773470|Diagnostic Test|Flexible Endoscopic Evaluation of Swallowing|Endoscopical swallowing study
15760423|NCT04773457|Other|Surgical Site Infection|infection at the site of the surgery (spine or abdomen)
15760424|NCT04773444|Behavioral|Eccentric cycling training|"Performed exercise training 5 days a week for 6 weeks on an eccentric ergometer.
~Each training session: 3 min at 30% of maximal workload (Wmax) for warmed up and cold down and 30 min the main training phase.
~Intensity: Firstly, set at 45% Wmax, and progressively increased 5% per week"
15760425|NCT04773444|Behavioral|Concentric cycling training|"Performed exercise training 5 days a week for 6 weeks on an eccentric ergometer.
~Each training session: 3 min at 30% of maximal workload (Wmax) for warmed up and cold down and 30 min the main training phase.
~Intensity: Firstly, set at 45% Wmax, and progressively increased 5% per week"
15760426|NCT04773431|Drug|LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) transplantation|LSCD101 (Cultured Autologous Limbal Epithelial Cell Sheet) is transplanted in the lesion.
15760427|NCT04773405|Drug|a 1: 1 mixture of 2% lidocaine with 5ug/ml epinephrine and 0.5% levobupivacaine|"This study adopts a Modified Narayana rule (MNR), a sequential up-and-down pharmacodynamics method (UDM) to estimate the minimum effective local anesthetic volume of 90% (MELAV90) of cases of the aforementioned local anaesthetic (LA) mixture, in order to produce the surgical anaesthesia of the whole upper extremity of the patients scheduled for upper limb surgeries. Based on the principal investigator's clinical experience, the initial volume of 21ml will be used. Depending on the success or failure of the SeTB, which is defined as the readiness for surgery at 30 minutes after the block, the volume for the next patient will be adjusted up or down by 3ml (1ml for each trunk of brachial plexus located above the clavicle). The upper dose limit of the study to minimize the potential for local anaesthetic systemic toxicity will be 30ml and the lower dose limit will be 12ml, which will be of no clinical importance."
15760428|NCT04773392|Drug|Twice-daily Tacrolimus|Within 48 hours of transplantation, immediate release tacrolimus (IRT) (0.1 mg/kg /day) will be administered twice a day.
15760429|NCT04773392|Drug|Once-daily envarsus XR|Within 48 hours of transplantation, Envarsus XR (0.13mg/kg/day) will be administered once a day.
15760430|NCT04773392|Drug|Induction Immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG)|Induction immunosuppression with Basiliximab or Rabbit Anti Thymoglobulin (rATG) per protocol. The dose of Basiliximab will be a standard of two 20 mg doses and total rATG will not exceed 6 mg/kg.
15760431|NCT04773392|Drug|Methylprednisolone, prednisone|Methylprednisolone intraoperatively (500mg) and immediately post transplantation (200mg on post operative day (POD) #1, 150mg on POD#2, 100mg on POD#3) then oral prednisone (50mg on POD #4, 20mg on POD #5). Oral prednisone will be tapered down to a minimal dose of 5mg within 6 weeks post transplantation.
15760432|NCT04773392|Drug|Mycophenolate mofetil (MMF) or Mycophenolic acid (MPA)|Mycophenolate mofetil (MMF) (up to 1000mg) or Mycophenolic acid (MPA) (up to 720mg) will be administered twice a day.
15760433|NCT04773392|Drug|Azathioprine|Azathioprine (1-3 mg/kg) will be administered once a day.
15760434|NCT04773366|Drug|Prednisone+Cytarabine+vincristine|Group 1 initial treatment (W1~W6). Prednisone 40mg/m2×4w, taper 2w; Vincristine 1.5mg/m2 iv d1 of w1,2,3,4,5,6; Cytarabine 100mg/m2 iv/IH d1-4 q2w (w1,3,5)
15760435|NCT04773366|Drug|Prednisone+Cytarabine+vincristine+Mercaptopurine|Group 1 Consolidation continuation treatment (W7~W22) . Prednisone 40mg/m2 d1-5 q3w (w7,10,13,16,19,22); VCR 1.5/m2 iv d1 q3w (w7,10,13,16,19,22); Cytarabine 100mg/m2 iv/IH d1-4 q3w (w7,10,13,16,19,22); 6-MP 50mg/m2/d,po,qn
15760436|NCT04773366|Drug|Prednisone+Cytarabine+vincristine+Mercaptopurine|Group 1 Maintenance continuation treatment (W25~52) . Prednisone 40mg/m2 d1-5 q3w; Vincristine 1.5/m2 iv d1 q3w; Cytarabine 100mg/m2 iv/IH d1-4 q6w ×3 times (w25,31,37); 6-MP 50mg/m2/d,po,qn
15760437|NCT04773366|Drug|Prednisone+Cytarabine+vincristine|Group 2 Initial treatment (W1~W6) . Prednisone 40mg/m2×4w, taper 2w; Vincristine 1.5mg/m2 iv d1 of w1,2,3,4,5,6; Cytarabine 100mg/m2 iv/IH d1-4 q2w (w1,3,5)
15760438|NCT04773366|Drug|Prednisone+vincristine+Mercaptopurine|Group 2 continuation treatment (W7~W52) . Prednisone 40mg/m2 d1-5 q3w; VCR 1.5/m2 iv d1 q3w; 6-MP 50mg/m2/d,po,qn
15760439|NCT04773366|Drug|Prednisone+vincristine|Group 3 Initial treatment (W1~W6) . Prednisone 40mg/m2×4w, taper 2w; Vincristine 1.5mg/m2 iv d1 of w1,2,3,4,5,6
15760440|NCT04773366|Drug|Prednisone+vincristine|. Group 3 Continuation treatment (W7~W52)Prednisone 40mg/m2 d1-5 q3w; Vincristine 1.5/m2 iv d1 q3w
15760441|NCT04773366|Other|Local therapy|Local therapy/wait and see. Group 4
15760444|NCT04773340|Behavioral|Dialectical Behavior Therapy|Behaviorally-focused intervention for individuals with personality disorder and a history of significant behavioral problems.
15760445|NCT04773327|Other|Mecapegfilgrastim Injection|24-48h after the end of antitumor drug administration in each chemotherapy cycle, Mecapegfilgrastim was injected subcutaneously, 6mg/ time, once/cycle
15760446|NCT04773314|Other|PROPESS Cohort|Non-intervention
15760447|NCT04773301|Drug|Levobupivacaine|Local anaesthetic drug belonging to the amino amide group. It is the S-enantiomer of bupivacaine
15760448|NCT04773301|Drug|Ropivacaine|Local anaesthetic drug belonging to the amino amide group. The name ropivacaine refers to both the racemate and the marketed S-enantiomer.
15760449|NCT04773288|Other|Live feedback during handwashing|Live feedback provided during handwashing on display
15760450|NCT04773249|Device|Lateral Epicondylitis Bandage|The lateral epicondylitis bandage was first used by Ilfeld in 1965, and it is a non-elastic band that prevents the expansion of the muscles in the proximal forearm. A lateral epicondylitis bandage will be given to the patient for 6 weeks. The bandage will be positioned 5 cm distal to the lateral epicondyle to allow for elbow flexion. After the application, patients will be asked to punch and the belt on the band will be tightened. After the patients are asked to open the fist, the suitability of the pressure applied to the forearm will be evaluated. Patients will be asked to repeat this application while wearing the band. The patients will also be asked to use the bandage throughout the day, and to remove them during bathing and sleeping.
15760451|NCT04773249|Device|Wrist Extension Splint|Wrist extension splint is an upper extremity orthosis that keeps the wrist at 15-20 degrees of extension with the polyethylene bar it contains. A wrist extension splint will be given to the patient for 6 weeks. The splint will be used to keep the wrist at 15-20 degrees of extension and to wrap the distal wrist and forearm without hindering finger movements. The patients will be asked to use the splint throughout the day, and to remove them during bathing and sleeping.
15760453|NCT04773236|Drug|2%lidocaine with 1:80.000 epinphrine|injection
15760454|NCT04773236|Device|Mixing pen (onset buffering system)|Premixing of the two solutions sodium bicarbonate and lidocaine with epinphrine before the local anesthesia adminstration to the patient
15760455|NCT04773223|Procedure|Open surgery and complex EVAR due to AAA|"There will be two cohorts:
~Patient undergoing open surgery
~Patients undergoing complex endovascular repair (fenestrated, chimney, etc.)"
15760456|NCT04773210|Device|Mini tube system|Mini tube system (FLOW-JAC System, Bogotá, Colombia) orthodontic treatment
15760457|NCT04773210|Device|Conventional ligating brackets|Conventional ligating brackets (Gemini 3M Unitek Orthodontic Products bracket, Calif, USA) with Nitinol Classic or superelastic (SE) archwires 0.014 and 0.016 orthodontic treatment
15760458|NCT04773197|Behavioral|Beating the Blues (BtB)|Beating the Blues (BtB) is a C-CBT intervention with 8 weekly sessions to be completed within 10 weeks.
15760459|NCT04773197|Behavioral|Entertain Me Well (EMW)|Entertain Me Well (EMW) is is a C-CBT intervention with 8 weekly sessions to be completed within 10 weeks.
15760460|NCT04773197|Behavioral|Coaching|A coach will spend approximately 5-10 minutes after each session with the patient to link the C-CBT content with patient's disease specific experiences and to motivate them to continue the program. They will also spend approximately 5 minutes between sessions to motivate a patient to complete assignments and to remind them about starting the next session on time.
15760461|NCT04773184|Procedure|Fiberoptic Endoscopic Evaluation of Swallowing|This procedure involves inserting a flexible laryngoscope that contains a light source and video camera on the end through the open passage of the nose towards the back of the throat in order to visualize the swallowing mechanism.
15760462|NCT04773184|Procedure|Videofluoroscopic Swallowing Study|Videofluoroscopic swallowing study will be performed to measure oropharyngeal swallowing. This is like a moving x-ray of the swallow.
15760463|NCT04773184|Procedure|Voluntary Peak Cough Flow Testing|Voluntary peak cough flow testing will be performed to determine the peak expiratory flow (PEF) and volume of air expelled (FEV1) during voluntary coughing.
15760464|NCT04773184|Procedure|Iowa Oral Performance Instrument|The Iowa Oral Performance Instrument (IOPI) is a device that measures the peak pressure performance of lingual strength and endurance via the action of a bulb placed on the hard palate.
15760465|NCT04773184|Procedure|Capsaicin Challenge|"A capsaicin challenge with three randomized blocks of 0, 50, 100, 200, and 500 μM capsaicin. The capsaicin will be dissolved in a vehicle solution consisting of 80% physiological saline, and 20% ethanol. Participants will be given the instruction cough if you need to prior to capsaicin delivery.The solution will be administered automatically upon detection of an inspired breath and there will be a minimum of one minute between each trial. This is to test the reflexive cough testing for upper airway sensitivity and motor thresholds."
15760466|NCT04773184|Procedure|Pulmonary Function Testing|Pulmonary Function testing will be performed using conventional methods and will include the following outcomes: forced vital capacity (FVC), maximum inspiratory pressure (MIP), and maximum expiratory pressure (MEP) expressed as a percentage of predicted values.
15760467|NCT04773171|Other|Computer-assisted Cognitive Remediation|Drill practice and bridging activities
15760468|NCT04773171|Other|Conventional training programmes|Existing conventional activities in the settings
15760469|NCT04773158|Behavioral|Clinical Decision Support|The intervention clinic sites will be provided access to a Clinical Decision Support System (CDSS) that incorporates the Rome IV criteria for evidence-based care recommendations for functional gastrointestinal disorders (FGIDs)
15760470|NCT04773145|Procedure|Hemiarthroplasty with hydroaxyapatite coated stem|Hemiarthroplasty with non cemented femoral stem, using the hydroxyapatite-coated femoral stem Pharo
15760471|NCT04773132|Other|Low Protein|Low protein/protein-free diet for 3 days (Day 1, 2 and Day 3) in order to deplete the label protein pool. The diet provided will meet the daily energy requirements of all the subjects.
15760472|NCT04773119|Procedure|PVI only|Patients in this group receive PVI only
15760473|NCT04773119|Procedure|PVI with substrate ablation|Patients in this group receive PVI as well as substrate ablation
15760474|NCT04773106|Device|ARGOS-SC suprachoroidal pressure sensor|Single-arm longterm follow-up ARGOS-SC suprachoroidal pressure Sensor System. The ARGOS-SC suprachoroidal pressure Sensor was already implanted in a previous Study-ARGOS-SC01.
15760475|NCT04773093|Drug|Continous Intravenous Lidocaine Infusion|Patient will recieve intravenous Lidocaine dose 1.5 mg/kg at the time of induction and after that will receive maintenance by continous intravenous Lidocaine infusion dose 2 mg/kg/hour until the completion of surgery
15760476|NCT04773093|Drug|Placebo|Patient will recieve Placebo NaCl 0.9% continuous intravenous infusion until the completion of surgery
15760479|NCT04773054|Diagnostic Test|Microbiological analysis of periprosthetic tissue|Microbiological culture of tissue samples collected intraoperatively from the newly-formed joint capsule, between prosthesis stem and femoral bone, and between the acetabular prosthesis and iliac bone.
15760480|NCT04773054|Diagnostic Test|Histological analysis of periprosthetic tissue|Histological assessment of cellular reactivity associated with the infection on tissue samples collected intraoperatively from the newly-formed joint capsule, between prosthesis stem and femoral bone, and between the acetabular prosthesis and iliac bone.
15760481|NCT04773054|Other|Characterization of tissue microbiota|"Assessment of tissue microbiome composition using the next-generation sequencing of DNA extracted from samples collected intraoperatively from the newly-formed joint capsule, between prosthesis stem and femoral bone, and between the acetabular prosthesis and iliac bone."
15760482|NCT04773054|Other|Characterization of gut microbiota|"Assessment of gut microbiome composition using the next-generation sequencing of DNA extracted from stool samples."
15760483|NCT04773054|Other|Characterization of oral microbiota|"Assessment of oral microbiome composition using the next-generation sequencing of DNA extracted from a buccal swab obtained by rubbing the mucosa of cheeks, gingivae, and palate."
15760484|NCT04773041|Procedure|Infinitome|All patients will have rs-FMRI images analyzed with the Infinitome cloud-based software processing program.
15760485|NCT04773028|Other|matrix metalloproteinase enzymes 2 and 9|concentration of matrix metalloproteinase 2 and 9 enzymes
15760486|NCT04773002|Other|Different anesthesia methods|Total intravenous anesthesia (TIVA)and volatile anesthesia
15760487|NCT04772989|Drug|AB308|Administered as specified in the treatment arm
15760488|NCT04772989|Drug|Zimberelimab|Administered as specified in the treatment arm
15760489|NCT04772976|Other|Observational study, not applicable|Observational study, not applicable
15760490|NCT04772963|Genetic|blood sample|During the arteriography a peripheral venous sampling
15760491|NCT04772937|Procedure|LLETZ|LLETZ is one of several possible surgical interventions for treating cervical dysplasia. The transformation zone of the cervix is completely removed
15760492|NCT04772937|Procedure|LEEP|LEEP is one of several possible surgical interventions for treating cervical dysplasia. Only the dysplastic lesion is removed without removing the whole transformation zone.
15760493|NCT04772924|Behavioral|fasting|more than 12 hour of fasting as ceremony of Ramadan
15760494|NCT04772924|Behavioral|not fasting|preferred not to take long term fasting
15760495|NCT04772911|Device|Optical Coherence Tomography (OCT)|OCT will be performed at baseline and prior to each standard of care laser treatment to characterize the mean diameter and depth of blood vessels.
15760496|NCT04772898|Behavioral|Hippotherapy|The hippotherapy involves occupational therapy while being on a horse.
15760497|NCT04772885|Drug|KT-474/Placebo|KT-474 or matching placebo oral tablet(s)
15760498|NCT04772885|Drug|KT-474|KT-474 oral tablet(s)
15760499|NCT04772872|Other|Assessment by Brazelton neonatal behavior for group A,Band C|"Neonatal neurobehavior will be measured by Brazelton neonatal behavior assessment scale.
~Neonatal maturity will be represented by the variance of estimated gestational age that determined by new Ballard score.
~Apgar score will be represented by the variance of degree of scores.
~Birth weight will be measured in grams."
15760500|NCT04772859|Behavioral|Online Lifestyle Intervention|"The intervention will be based on the Planet Nutrition program. This program was previously designed by the present research group and has a handbook that includes nutrition topics, framed by different behavior change strategies. The nutrition education and physical activity sessions will be offered 3 days a week, in the same 1-hour class: 30 minutes for each.
~Nutrition education: presentations based on the Planet Nutrition program, a dedicated website, and the Zoom application, will be used to deliver the intervention. The website will be used to upload the nutrition materials and the recorded sessions. Participants will work on self-monitoring of different health behaviors.
~Physical activity: The classes will be delivered by the Physical Activity team through the Zoom application. A website will be used to upload the recorded sessions.
~Parents participation. The same website and a private Facebook group will be used to upload nutrition information once a week."
15760501|NCT04772859|Other|Control Group|They will receive one digital brochure with general information on a healthy diet, at the beginning of the program.
15760502|NCT04772846|Drug|Oral tablet|Oral 250mg chloroquine tablets
15760503|NCT04772846|Drug|Placebo|Oral placebo tablets
15760504|NCT04772833|Other|Autopsy|The subjects deceased will undergo an autopsy to analyze the histopathological, ultrastructural and microbiological findings, related to the COVID-19 disease.
15760505|NCT04772820|Behavioral|Telephone-based coaching|A telephone-based brief behavioral activation coaching program that will involve 10 sessions over 4 months. Sessions will focus on helping people to identify meaningful activities that they can safely do to decrease loneliness, increase physical activity and improve nutrition.
15760506|NCT04772807|Device|Kinocardiograph|Measure with the Kinocardiograph device and the Okcardio application installed on a smartphone
15760507|NCT04772794|Other|fraction of inspired oxygen|after induction of general anaesthesia, different fraction of inspired oxygen will be given to patient according to their group allocation
15760508|NCT04772781|Drug|S (+) - Ibuprofen|S (+) - Ibuprofen + placebo of Ibuliv®
15760509|NCT04772781|Drug|Ibuliv®|Ibuliv® + placebo of S (+) - Ibuprofen
15760510|NCT04772755|Device|Buzzy® and Electronic Game|Buzzy® will be applied according to manufacturers directions and an electronic game will be played. The participant will be observed for 20 minutes post vaccination.
15760511|NCT04772742|Drug|Placebo|Placebo - solution for infusion
15760512|NCT04772742|Drug|Eptinezumab|Eptinezumab - 100 mg, solution for infusion
15760513|NCT04772729|Drug|Insulin faster aspart (Fiasp, Novo Nordisk)|"Duration of the study: 10 weeks.
~It is assumed that the patients will attend 4 visits in Pediatric Diabetology Clinic, and 3 telephone consultations.
~W0: The study will start with a 2-week run-in period in order to normalize glycemia.
~W1: RT-CGM will be inserted. Subsequently, the participants will be randomly assigned to one of two groups (Fa-A or A-Fa), basing on which the order of insulin use will be determined.
~W2: after 2 weeks, diabetology telephone consultation (washout period).
~W3: after 2 weeks, diabetology consultation. Changing insulin type according to the allocation.
~W4: after 2 weeks, diabetology telephone consultation (washout period).
~W5: after 2 weeks, diabetology telephone consultation.
~W6: the results obtained throughout the study will be discussed with the patient and the parent."
15760514|NCT04772716|Procedure|operation|The intervention was not decided by the investigator but studied following emergency or elective surgeries undergoing in the system
15760515|NCT04772703|Diagnostic Test|COMET ASSAY|The description in the detailed description of the study
15760516|NCT04772690|Other|A resource-oriented intervention|The intervention is delivered by an interdisciplinary team of occupational therapist, physiotherapist, nurse, psychologist, physician and social worker. It consists of a five-day residential stay at REHPA and a two-day follow-up stay after seven weeks at home. The residential stays include both workshops and engagement in physical and creative activities.
15760517|NCT04772677|Behavioral|BEAM Mental Health and Parenting Program|The BEAM program is a novel mobile app-based therapeutic intervention that incorporates key parenting concepts and Unified Protocol (UP) therapy modules with clinician-facilitated peer social support and connection. The primary aim of the program is to improve symptoms of depression and promote a positive parent-child relationship. There are three main components of the program: 1) the UP content, which will target maternal mental health symptomology, 2) the parenting skills training content, which is designed to correspond to the UP modules and promote maternal responsivity to children's emotions, and 3) a closed online community forum to encourage social support and connection between participants of the program.
15760551|NCT04772417|Diagnostic Test|Standardized 1-minute sit-to-stand test|The individuals perform two tests from a standardized chair (seat height 46cm).
15760518|NCT04772664|Dietary Supplement|Multispecies-Probiotic|Participants in intervention group receive 2x3g of a multistrain probiotic containing Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Bifidobacterium lactis W52, Lactobacillus acidophilus W22, Lactobacillus casei W56, Lactobacillus paracasei W20, Lactobacillus plantarum W62, Lactobacillus salivarius W24, Lactococcus lactis W19.
15760519|NCT04772664|Dietary Supplement|Placebo Supplement|Participants in the placebo group receive 2x3 gram of a placebo supplement not containing probiotic strains.
15760520|NCT04772651|Other|Mediterranean Diet|Diet meeting the requirements for mediterranean style (rich in vegetables, fruit, olive oil, fish) (Davis et al., 2015)
15760521|NCT04772651|Other|Normal hospital diet|Normal hospital diet
15760522|NCT04772651|Other|dietary coaching|dietary coaching
15760523|NCT04772651|Other|Psychoeducation on depression|Psychoeducation on depression (50minutes once a week for 4 weeks)
15760524|NCT04772638|Behavioral|PLAY|This intervention focuses on promoting physical activity in preschoolers and the adults (parents and teachers) in their lives. It consists of 1) Teacher training 2) Activity trackers for children, teachers and parents and 3) text messaging with content and individualized goal setting.
15760525|NCT04772638|Other|Wait list control|not an active intervention
15760526|NCT04772625|Procedure|Patellofemoral arthroplasty|Insertion of an artificial joint between the front of the femur and the back of the patella. The femoral component consists of a metal implant, and the patellar component is a polyethylene implant. The two components replace the original articular cartilage of the patellofemoral joint.
15760527|NCT04772612|Drug|sitravatinib|sitravatinib
15760528|NCT04772560|Device|Precision1 for Astigmatism|Daily disposable soft toric contact lens
15760529|NCT04772560|Device|Precision1 Sphere|Daily disposable soft spherical contact lens
15760530|NCT04772547|Drug|Vigabatrin Only Product|enteral medication administration, serial blood draws, and outcome assessment
15760531|NCT04772534|Biological|9vHPV vaccine|9-valent human papillomavirus (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
15760532|NCT04772521|Behavioral|General health talk|Health talk provided information about hazards of tobacco (active smoking, second- and third-hand smoke), benefits of quitting smoking and methods to quit smoking.
15760533|NCT04772521|Behavioral|Personalized chat-based interactions|Individual chat-based interactions last 3 months and consist of 2 parts. First part is regular message. The schedule will be adjusted according to the participants' quitting and mental health status. The second part includes real-time psycho-behavioral intervention delivered by trained cessation counsellors using the acceptance and commitment therapy (ACT) model for smoking cessation and reliving mental health problems. The conversation is based on participants' socio-demographic characteristics, smoking habit at baseline, and updated smoking status and mental health status assessed during online conversation and the baseline questionnaire.
15760534|NCT04772521|Behavioral|Text message|Regular messages will be sent twice per month within 3 months. These messages covers simple cessation advice and reminders for follow-ups.
15760535|NCT04772521|Behavioral|Phone follow-up/counselling service|The intervention outcomes and participants' smoking status will be followed up regularly via telephone interviews (15 - 30 minutes).
15760536|NCT04772521|Drug|Mailed nicotine replacement therapy (NRT)|Full course of NRT treatment (8 weeks) will be provided to all participants who are still smoking at 6-month follow-up and request, or willing to use NRT after advice from counsellors. Medications will be mailed from the smoking cessation clinics.
15760537|NCT04772508|Procedure|Scaling and root planing|15 sites with periodontal pockets ≥ 5mm received only SRP
15760538|NCT04772508|Biological|Amnion membrane|15 sites with periodontal pockets ≥ 5mm received SRP along with placement of amnion membrane.
15760539|NCT04772508|Drug|Taurine|15 sites with periodontal pockets ≥ 5mm received SRP along with placement of amnion membrane hydrated with taurine.
15760540|NCT04772495|Genetic|miRNA|miRNA effect on Multiple sclerosis pathology
15760541|NCT04772482|Diagnostic Test|Sensitivity Patch Testing|Testing patches will be applied on the upper arms. Para-phenylene diamine (PPD) 1% will be applied on one upper arm. Para-toluenediamine sulfate (PTD), 2-methoxyethyl p-phenylenediamine (ME-PPD), PPD6 and PPD7 will be applied to the other upper arm.
15760542|NCT04772469|Behavioral|Provision of multiple self-tests|Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for men in their social networks.
15760543|NCT04772469|Other|Small monetary incentives|Use of small incentive voucher (~$5) to encourage linkage to confirmatory testing.
15760544|NCT04772469|Behavioral|Use of SMS/text reminders to motivate adherence to ART or PrEP|"Messages will be motivational, will not include any identifying information and will include generic texts such as maintain your good health, to cater for status-neutral language that can work for both HIV positive individuals taking ARVs, as well as HIV-negative individuals on PrEP who may need adherence support."
15760545|NCT04772456|Drug|Hyperpolarized 13C-Pyruvate|"Hyperpolarized Pyruvate (13C) Injection, containing spin-polarized (hyperpolarized) [ 13C]pyruvate, is being studied as a diagnostic agent in combination with 13C spectroscopic MR imaging. The aim is to visualize [13C]pyruvate and its metabolites and thereby distinguish between anatomical areas with normal vs. abnormal metabolism, which should be useful in diagnosing and characterizing, for example, malignancy.
~Hyperpolarized Pyruvate (13C) Injection and [13C]pyruvate are general terms used throughout this brochure, that refer to all 13C labeling patterns, such as [1- 13C]pyruvate, [2- 13C]pyruvate and [1,2- 13C]pyruvate. From biological and safety standpoints, pyruvate with each of the labeling patterns behaves identically in the human body [Koletzko et al., 1997]."
15760546|NCT04772443|Drug|DWJ1506|DWJ1506
15760547|NCT04772443|Drug|DWJ1507|DWJ1507
15760548|NCT04772443|Drug|DWC202011|DWC202011
15760549|NCT04772443|Drug|DWJ1177|DWC202011
15760550|NCT04772430|Radiation|snow globe|"Control group; The baby whose height and weight measurements will be taken will be taken to the stretcher, and the vaccine will be administered after the pain score is measured before the procedure. Pain scores will be recorded during and after the procedure.
~Experimental group; The baby whose height and weight measurements will be taken will be taken to the stretcher, after the pain score is measured before the procedure, the snow globe will be operated and the vaccine will be applied. The snow globe will continue to work until the application is completed. Pain scores will be recorded during and after the procedure."
15760552|NCT04772417|Diagnostic Test|Individualized 1-minute sit-to-stand test|The individuals perform two tests from an individualized chair (seat height adjusted so that the starting position elicits a knee flexion angle of 90°).
15760553|NCT04772391|Other|Exercise Sessions|Participant will complete up to 8 exercise sessions
15760554|NCT04772378|Biological|HB-adMSCs|
15760555|NCT04772365|Drug|SHR-1819|SHR-1819 will be subcutaneously administered with different dose levels;
15760556|NCT04772365|Drug|Placebo|Placebo will be subcutaneously administered with different dose levels;
15760557|NCT04772352|Drug|febuxostat treatment|According to NAFLD guidelines, participants accept febuxostat treatment (40mg, once a day, orally)
15760558|NCT04772352|Behavioral|lifestyle intervention|According to NAFLD guidelines, participants receive lifestyle intervention (diet and exercise).
15760559|NCT04772339|Other|Heel-Rise Test|The Heel Rise test for endurance will be performed while the participant stands on a box with 10 ° inclination on one leg. Participants will be allowed to get support from the wall at the point at shoulder level with two fingertips in order to maintain balance. A metronome of 30 beats per minute will be used to maintain the heel-rise frequency every 2 seconds. The participant will be asked to rise as high as possible with each heel rise, then lower the heel to the starting position, and with the next warning, he/she will be asked again. The participant will be asked to adapt to the pace of the metronome as much as possible and to continue the test as much as possible. The test will be terminated when the participant stops, fails to maintain frequency, or performs a proper heel raise. The number of heel raises obtained at the end of the test will be used for data analysis.
15760560|NCT04772339|Other|Paper Grip Test (PGT)|In the paper grip test, a paper is placed under the individual's thumb and the person is asked to squeeze this paper strongly between the big toe and the ground. The paper is pulled by the person performing the test and the individual is asked to hold the paper with his/her thumb as much as he/she can. When the person applies the maximum force, the height of the medial longitudinal arch is measured with a digital caliper in millimeters. The time that the individual can maintain the MLA height with this maximum force is recorded with a stopwatch.
15760561|NCT04772326|Other|Questionnaire|Questionnaire
15760562|NCT04772313|Biological|Pegloticase|Participants will receive MTX during the run-in period then pegloticase with MTX for up to 24 weeks during the treatment period. Participants may opt to receive pegloticase with MTX for an additional 24 weeks.
15760563|NCT04772300|Combination Product|Percutaneous Transluminal Angioplasty (PTA) MagicTouch Sirolimus Coated PTA Balloon Catheter|PTA with an sirolimus drug-coated balloon catheter (SRL-DCB) in the infrapopliteal artery
15760564|NCT04772300|Device|Percutaneous Transluminal Angioplasty (PTA) with non-coated balloon catheter (POBA)|PTA with an non-coated balloon catheter (POBA) in the infrapopliteal artery
15760565|NCT04772287|Drug|Toripalimab|Toripalimab: 240mg, IV, q3w, 4 cycles in total; Platinum-containing dual-drug chemotherapy: The specific dose is based on the standard of the selected protocol, IV, q3w, a total of 4 cycles.
15760566|NCT04772287|Drug|Toripalimab mimetic (placebo)|Placebo: 240mg, IV, q3w, 4 cycles in total; Platinum-containing dual-drug chemotherapy: The specific dose is based on the standard of the selected protocol, IV, q3w, a total of 4 cycles.
15760567|NCT04772274|Drug|Ustekinumab|45 mg, single-dose
15760568|NCT04772261|Diagnostic Test|13C-Spirulina GEBT|Various lots of 13C-Spirulina GEBT test meals
15760569|NCT04772248|Drug|Tofacitinib|First eligible prescription for treating rheumatoid arthritis (RA)
15760570|NCT04772248|Drug|TNF Inhibitor|First eligible prescription for treating rheumatoid arthritis (RA)
15760571|NCT04772235|Drug|Repotrectinib|"Repotrectinib will be taken orally once daily with or without food Part A: Dose escalation phase, with 3 dose levels for repotrectinib: (1) 80 mg QD, (2) 160 mg QD and (3) 160 mg QD for 14 days followed by 160 mg BID; in combination with 80 mg QD of osimertinib
~Part B: at the RP2D for all patients in combination with osimertinib."
15760572|NCT04772235|Drug|Osimertinib|"Osimertinib will be taken orally at 80 mg once daily with or without food. Part A: lead in dose in monotherapy at 80 mg QD during 14 days. In combination with repotrectinib afterwards. Depending on the safety and PK/ dose dependent interactions (DDIs) readout during the DLT assessment period, osimertinib dose may be adjusted.
~Part B: at the RP2D level in combination with repotrectinib"
15760573|NCT04772222|Drug|Dexmedetomidine Hydrochloride|Potent α2-adrenergic receptor agonist that provides sedation, analgesia, and prevents shivering but does not suppress ventilation.
15760574|NCT04772222|Drug|Morphine Sulfate|Opioid agonist that provides analgesia, pain management and sedation and may suppress ventilation.
15760575|NCT04772209|Drug|Sodium bicarbonate|Dialysis catheter lumen will be filled (locked) by sodium bicarbonate solution. The amount of solution depends on the diameter and length and will be in accordance with the manufacturer's specifications.
15760576|NCT04772209|Drug|Heparin|Dialysis catheter lumen will be filled (locked) by classic heparin. The amount of pure heparin depends on the diameter and length and will be in accordance with the manufacturer's specifications.
15760577|NCT04772196|Drug|Vitamin D3|50,000 IU Vitamin D3 weekly for 8 weeks
15760578|NCT04772183|Device|SpO2 and SaO2 comparaison|"Serveral pulse oximeter will be place on patient find few minutes before arterial blood gases.
~During an arterial blood sample, all SpO2 will be recordered"
15760579|NCT04772157|Diagnostic Test|Cardiac Troponin Testing|Lithium heparin whole blood and plasma samples will be measured with Siemens POC High Sensitivity Troponin-I Test System.
15760580|NCT04772144|Behavioral|behavioural and cessation aids|information, motivational interview, refferal to healty life-centers, free cessation aids
15760581|NCT04772131|Device|Desara® One Single Incision Sling|Single incision sling
15760582|NCT04772131|Device|Desara® Blue Transobturator Sling|Standard mid-urethral sling
15760583|NCT04772118|Other|Carevive PROmpt™|Patient Reported Outcomes Mobile Patient (Carevive PROmpt™), a digital cancer symptom monitoring platform.
15760584|NCT04772105|Drug|2.5mg of BAT5906|Specification: 2.5mg of BAT5906
15760585|NCT04772105|Drug|4.0mg of BAT5906|Specification: 4.0mg of BAT5906
15760586|NCT04772092|Biological|Blood samples|"during the routine blood test, collection of additional blood samples:
~1 x 5 mL heparinized tube for plasma collection and storage
~1 heparinized 5 mL tube for immunophenotyping
~4 x 10 mL EDTA tubes for white blood cell (WBC) collection and cryopreservation"
15760655|NCT04771585|Other|FFP3 respirator|Filtering Face Piece with no less than 99% filtering capacity, CE-certified
15760587|NCT04772092|Other|Data collection|"clinical examination data
~test results to measure the degree of geriatric fatigability
~Frailty screening questionnaire for neoplasia patients (G8 score)"
15760588|NCT04772079|Drug|BMS-986165|Specified dose on specified days
15760589|NCT04772079|Other|Placebo matching BMS-986165|Specified dose on specified days
15760590|NCT04772066|Other|Measure of medication adherence|Measure of medication adherence
15760591|NCT04772053|Procedure|Tumor biopsy|Archived or fresh tumor biopsy samples will be collected.
15760592|NCT04772040|Dietary Supplement|Fish oil supplementation|Fish oil capsules.
15760593|NCT04772001|Drug|Hydrochloride anlotinib|Hydrochloride anlotinib is a small molecular anti-angiogenesis drug with multiple targets. It will be taken at a starting dose of 12 mg for 14 days. Then participants will rest for 7 days and start a new cycles. At most of 3 cycles will be administrated. If intolerable toxicity happen, dosage of 10mg or 8mg will be taken.
15760594|NCT04772001|Drug|cis Platinum/carboplatin|Concurrent chemotherapy will be administrated weekly during radiation for a total of 5-6 doses. Cisplatin of 40mg/m2 will be the most preferred regime. For patients with intolerable toxicity of cisplatin, carboplatin of AUC 2 will be the alternative drug.
15760595|NCT04772001|Radiation|External beam radiotherapy and brachytherapy|Radiation will be given by external beam of 45Gy total dose and 3D-brachytherapy of 30Gy/5F or 28Gy/4F. Duration of radiotherapy will be no more than 8 weeks.
15760596|NCT04771988|Radiation|yttrium-90 radioembolization|selective/superselective treatment using resin microspheres labeled with Yttrium-90
15760597|NCT04771975|Behavioral|Exercise Counselling|See previous description for MatchQEP (Intervention) group.
15760598|NCT04771975|Behavioral|Partner Matching|"All participants will be matched with another participant (fellow BCS) and will facilitate / support exercise with their partner for the duration of the study.
~Participants will be matched based on personal and cancer-related characteristics."
15760600|NCT04771949|Diagnostic Test|Full periodontal chart|A full periodontal chart will be carried out including all biometric periodontal variables: Probing Pocket Depth (PPD), Bleeding on Probing (BoP), presence of Plaque, recession (REC), Full Mouth Plaque Score (FMPS), Full Mouth Bleeding Score (FMBS), presence of furcation and mobility. Periodontal status, as assessed by the periodontal chart, will be evaluated following the New Classification of Periodontal and Peri implant diseases.
15760601|NCT04771949|Other|Questionnaires|"After the periodontal chart, patients will be administered the italian version of 4 questionnaires regarding:
~Adherence to Mediterranean Diet (Gnagnarella et al. 2018);
~International Physical Activity Questionnaire (IPAQ) (Mannocci et al. 2010);
~Pittsburgh Sleep Quality Index (PSQI) (Curcio et al. 2013);
~Italian Perceived Stress Scale (Fossati, 2010)."
15760602|NCT04771936|Other|Physiotherapy Exercises|All patients shall be randomly assigned to 3 groups: the control group who shall be awaiting surgery and not receiving a regular physiotherapy, the exercise group who shall be subject to a set of conventional exercises and a core exercise group who shall be performing the conventional exercises plus exercises aimed at the activation of core muscles. These exercises shall be carried out 3 times weekly for a period of 3 months. During the first 4 weeks, all sessions shall be supervised by a physiotherapist. From the 5th to the 8th week, patients shall attend 2 supervised sessions and complete the 3rd one at home. Between the 9th and the 12th week, patients shall then attend 1 supervised intervention and complete 2 sessions at home.Patients assigned to the control group shall be given a chance to enrol into the program upon completion of the study if they wish to do so.
15760603|NCT04771923|Drug|Tranexamic acid|Topical instillation of tranexamic acid up to 3x. If bleeding is not controlled patients crossover to adrenaline.
15760604|NCT04771923|Drug|Adrenaline|Topical instillation of adrenaline up to 3x. If bleeding is not controlled patients crossover to tranexamic acid.
15760605|NCT04771910|Other|Topical cream with live probiotic bacteria|Application of the probiotic cream once a day, for approximately 8 weeks on one side of the body (elbow or knee cavity; decided by doctor in advance, same as placebo cream). Assessment before product use (T0), after 4 and 8 weeks of product use (T4w and T8w, respectively) and after 4 weeks without product use (T12w).
15760606|NCT04771910|Other|Placebo cream|Application of the placebo cream (same formulation as probiotic cream except live probiotic bacteria) once a day, for approximately 8 weeks on one side of the body (elbow or knee cavity; decided by doctor in advance, same as probiotic cream). Assessment before product use (T0), after 4 and 8 weeks of product use (T4w and T8w, respectively) and after 4 weeks without product use (T12w).
15760607|NCT04771897|Drug|BXQ-350 - Part 1 Dose Escalation: Safety and Tolerance|BXQ-350 is a novel anti-neoplastic therapeutic agent configured from two components: Saposin C (SapC), an expressed (human) lysosomal protein, and the phospholipid dioleoylphosphatidyl-serine (DOPS), a phospholipid located on cell membranes (clinical formulation BXQ-350). During Part 1, BXQ-350 will be administered by intravenous (IV) infusion over twelve months.
15760608|NCT04771897|Drug|BXQ-350 - Part 2 BXQ-350 Tumor and Plasma Concentrations|BXQ-350 is a novel anti-neoplastic therapeutic agent configured from two components: Saposin C (SapC), an expressed (human) lysosomal protein, and the phospholipid dioleoylphosphatidyl-serine (DOPS), a phospholipid located on cell membranes (clinical formulation BXQ-350). During Part 2, BXQ-350 will be administered by intravenous (IV) infusion over twelve months.
15760609|NCT04771884|Drug|meropenem vancomycin ceftazidime ceftriaxone ceftizoxime linezolid|The use of antimicrobial agents depends on the clinical practice
15760610|NCT04771871|Drug|Epirubicin|Epirubicin is an antitumor antibiotics with good activity on breast cancer. It has less cardiotoxic effect than doxorubicin
15760611|NCT04771871|Drug|Cyclophosphamide|Cyclophosphamide is a cytoxic drug indicated for the treatment of many malignancies including breast cancer
15760612|NCT04771871|Drug|Paclitaxel|Paclitaxel is a taxane chemotherapy agent indicated for the treatment of many cancers including breast cancer. It can be used alone or in combination with other drugs
15760613|NCT04771871|Drug|Carboplatin|Carboplatin is a platinum compound indicated for the treatment of many types of malignancies including breast cancer
15760614|NCT04771845|Device|Transcranial Magnetic Stimulation|Magnetic stimulation to alter neural activity
15760615|NCT04771832|Procedure|ERAS|Enhanced Recovery After Surgery (ERAS) protocol is an evidence-based multimodal perioperative protocol focused on stress reduction and the promotion of a return to function
15760617|NCT04771806|Procedure|Magnetic Resonance Imaging|Undergo MRI
15760618|NCT04771806|Other|Neurocognitive Assessment|Undergo neurocognitive testing
15760619|NCT04771806|Other|Quality-of-Life Assessment|Ancillary studies
15760620|NCT04771806|Other|Questionnaire Administration|Ancillary studies
15760621|NCT04771793|Behavioral|new physical restraint protocols|new physical restraint protocols
15760622|NCT04771780|Drug|KHK7791|oral administration
15760623|NCT04771767|Drug|Ketamine|Patients will receive 6 sub-anesthetic IV ketamine infusions over 8 weeks, each one lasting 40 minutes.
15760624|NCT04771767|Behavioral|Online Trauma-Focused Cognitive Behavioural Therapy|Participants will enrol in a 14-week online CBT program mirroring in-person trauma-focused CBT.
15760625|NCT04771754|Drug|Dolutegravir|50 mg once daily orally
15760626|NCT04771741|Drug|Acetominophen|1,000 mg every 6 hours
15760627|NCT04771741|Drug|Toradol|10 mg every 6 hours, days 0-3
15760628|NCT04771741|Drug|Meloxicam|15 mg once daily, beginning post-op day 4
15760629|NCT04771741|Drug|Cyclobenzaprine|10 mg every 8 hours
15760630|NCT04771741|Drug|Lyrica|75 mg every 12 hours
15760631|NCT04771728|Drug|Metronidazole vaginal suppositories|Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days )
15760632|NCT04771728|Drug|Metronidazole vaginal suppositories and Probiotics(Umeta-mimi)|Metronidazole vaginal suppositories (200 mg,2 capsules per day,7 days ) and Oral pobiotics(Umeta-mimi,5×109cfu per day,30 days）
15760633|NCT04771715|Drug|Regorafenib|Medical records are reviewed to identify participants who received at least one dose of regorafenib plus a PD-1 inhibitor (nivolumab/pembrolizumab/camrelizumab/sintilimab/toripalimab/tislelizumab) in routine medical care.
15760634|NCT04771715|Drug|Nivolumab|Medical records are reviewed to identify participants who received at least one dose of regorafenib plus a PD-1 inhibitor (nivolumab/pembrolizumab/camrelizumab/sintilimab/toripalimab/tislelizumab) in routine medical care.
15760635|NCT04771715|Drug|Pembrolizumab|Medical records are reviewed to identify participants who received at least one dose of regorafenib plus a PD-1 inhibitor (nivolumab/pembrolizumab/camrelizumab/sintilimab/toripalimab/tislelizumab) in routine medical care.
15760636|NCT04771715|Drug|Camrelizumab|Medical records are reviewed to identify participants who received at least one dose of regorafenib plus a PD-1 inhibitor (nivolumab/pembrolizumab/camrelizumab/sintilimab/toripalimab/tislelizumab) in routine medical care.
15760637|NCT04771715|Drug|Sintilimab|Medical records are reviewed to identify participants who received at least one dose of regorafenib plus a PD-1 inhibitor (nivolumab/pembrolizumab/camrelizumab/sintilimab/toripalimab/tislelizumab) in routine medical care.
15760638|NCT04771715|Drug|Toripalimab|Medical records are reviewed to identify participants who received at least one dose of regorafenib plus a PD-1 inhibitor (nivolumab/pembrolizumab/camrelizumab/sintilimab/toripalimab/tislelizumab) in routine medical care.
15760639|NCT04771715|Drug|Tislelizumab|Medical records are reviewed to identify participants who received at least one dose of regorafenib plus a PD-1 inhibitor (nivolumab/pembrolizumab/camrelizumab/sintilimab/toripalimab/tislelizumab) in routine medical care.
15760640|NCT04771702|Device|Edmon|Exhaled air will be analyzed for propofol
15760641|NCT04771689|Drug|Buprenorphine/Naloxone|Subjects will be randomized into one of the treatment groups and will follow the assigned medication schedule for the length of their hospital stay, at least 6 days.
15760642|NCT04771676|Drug|Oncorine (H101)|A modified human recombinant type 5 adenovirus with genetic modifications.
15760643|NCT04771663|Other|Breathing a mixture of O2, N2 and CO2 and monitoring SpO2 on each finger|The experiment consists of two separate phases. In one phase, the volunteers inhale one of the mixtures for five minutes. After enough time of recovery, the volunteers undergo the other phase in which they inhale the other mixture of gases. Both phases of the measurement will begin with a two-minute stabilization phase, during which the physiological values of the volunteer will be checked. During the experiment, non-invasive SpO2 measurements will be performed continuously on the individual fingers of both volunteer hands throughout the experiment.
15760644|NCT04771650|Other|CAMI|The CAMI is a culturally adapted motivational interview. It is a single 75 minute session that focuses on promoting motivation to change drinking and drug use behavior.
15760645|NCT04771637|Drug|Dexmedetomidine|The loading dose with 0.5 μg/kg, maintenance dose with 0.5 μg/kg of Dexmedetomidine is used to observe the effect on the electrolyte and quality of recovery of the patients
15760646|NCT04771637|Drug|Dexmedetomidine|The loading dose with 1.0 μg/kg, maintenance dose with 0.25 μg/kg of Dexmedetomidine is used to observe the effect on the electrophysiology and quality of recovery of the patient
15760647|NCT04771637|Drug|Dexmedetomidine|The loading dose with 1 μg/kg, maintenance dose with 0.5 μg/kg of Dexmedetomidine is used to observe the effect on the electrophysiology and quality of recovery of the patients
15760648|NCT04771637|Drug|Normal saline|Normal saline is used to observe the effect on the electrophysiology and quality of recovery of the patients
15760649|NCT04771611|Drug|Fisetin|~20mg/kg /day oral for four days (days 0,1 and days 8,9)
15760650|NCT04771598|Other|Breathing exercise with the phone application|"Respiratory Control:
~Pursed Lip Breathing
~Diaphragmatic Breathing Respiratory exercises will be instructed to the individuals forming the intervention group and participants will be asked to do 3 times a day during one month and the exercises will be done by the researchers together with the individuals by establishing a connection with the phone application (zoom, watsapp) once a week from home."
15760651|NCT04771598|Other|Breathing exercise|"Respiratory Control:
~Pursed Lip Breathing
~Diaphragmatic Breathing Breathing exercises will be explained to the control group and visual material will be given. The participants will be asked to do 3 times a day during one month. In terms of physical activity, the patient will be encouraged to participate in the program by suggesting exercises such as walking and cycling at least three times a week for 20 minutes per week"
15760652|NCT04771585|Other|Community Mask|Fabric mask, no medical device
15760653|NCT04771585|Other|Surgical Mask|Medical face mask (personal protective equipment), CE-certified
15760654|NCT04771585|Other|FFP2 respirator|Filtering Face Piece with no less than 94% filtering capacity, CE-certified
15760656|NCT04771572|Drug|LP-118|Evaluate safety and tolerability profile and pharmacokinetics of oral LP-118 in patients on a once daily schedule.
15760657|NCT04771559|Other|COVID-19 antibody test|5 cc blood sample from each participant will be taken 4 weeks after the second dose of the COVID-19 vaccine . After blood samples are centrifuged at 2500 rpm for 10 minutes, the separated serum will be backed up in two different ependorphs and stored at -80 or -20 degrees. The samples will be delivered to the working center in a manner suitable for cold chain transport. COVID-19 antibody test will be performed on the blood samples
15760658|NCT04771546|Device|Colpofix|Intravaginal gel with carboxymtheyl beta-glucan and polycabophil. Posology: 1 application / day x 20 days, rest 10. Repeat 20 x 3 cycles
15760659|NCT04771533|Procedure|hand motor coordination in a sitting position|The subject sat on the therapeutic table (without back support), feet resting on the floor. The upper limb was to be examined in adduction of the humeral joint, with the elbow bent in the intermediate position between pronation and supination of the forearm, with free wrist and the hand. After putting the glove on, the range of passive movement in the radial-carpal joint (flexion and extension) and fingers (global flexion and extension) was measured. Then the subject made active movement in the same order. Finally, the subject was asked to make moves as quickly and in as full a range as possible. Finally, the measurement of grip strength with a dynamometer was performed.
15760660|NCT04771533|Procedure|hand motor coordination in a supine position|In the supine position, the upper limb was stabilized at the subject's body (adduction in the humeral joint, elbow flexion in the intermediate position, wrist and the hand free). After putting the glove on, the range of passive movement in the radial-carpal joint (flexion and extension) and fingers (global flexion and extension) was measured. Then the subject made active movement in the same order. Finally, the subject was asked to make moves as quickly and in as full a range as possible. Finally, the measurement of grip strength with a dynamometer was performed.
15760661|NCT04771520|Drug|Avapritinib|Given PO
15760662|NCT04771507|Drug|Ibrutinib|Ibrutinib will be stopped at inclusion in the and the patient will be followed OFF therapy. At clinical progress, ibrutinib will be restarted (ON period) at the same standard dose as used at inclusion. When the patient achieve at least partial response again, a new OFF period is started, and so on.
15760663|NCT04771494|Other|Power and execution speed as a function of instability experience|"Each subject performed 3 repetitions for the light load (40% RM; VMP > 1.0 m/s), with 1 minute rest; 2 repetitions for the medium load (60% RM; 0.65 m/s ≤ VMP ≤ 1.0 m/s) with 2 minutes rest and 1 repetition for the heavy load (80% RM; VMP < 0.65 m/s) with 4 minutes rest. A metronome was used for the start countdown and to time the eccentric and concentric portions of the exercise.
~Subjects began the bench press with their elbows fully extended, maintaining a grip distance slightly greater than shoulder width. The bar was then lowered to their chest and then applying as much thrust as possible until full elbow extension on a 2-1-0 count. The timing sequence involved 2 seconds for the eccentric phase, a 1 second hold (to minimise the contribution of the rebound effect and allow for more reproducible and consistent measurements) and for the concentric up phase the highest possible execution speed, until the bar returned to the starting position."
15760664|NCT04771481|Drug|Metoclopramide|metoclopramide 10 mg intravenous form
15760665|NCT04771481|Drug|Normal Saline 10 mL Injection|Normal saline 10 ml intravenous form
15760666|NCT04771468|Device|MOSTCAREup Monitoring|The patients will be equipped with mini-invasive hemodynamic monitoring (the MOSTACAREup system). The MOSTCAREup obtains the hemodynamic data from either the same arterial femoral line used by the neuro-radiologist to perform the treatment or from a dedicated radial artery, as decided by the attending anesthetist to monitor and optimize arterial pressure (the decision to use the arterial line is at discretion of the attending anesthetist for clinical reasons and does not delay the procedure, which starts using always the femoral access).
15760667|NCT04771468|Device|Ecocardiography|Echocardiography will be performed 1) soon after the end of the treatment (whenever possible, avoiding delays, before od during the treatment in the angiography room); 2) at day 1 after the procedure; 3) at day 3 after the procedure.
15760668|NCT04771455|Behavioral|Behavioral weight loss|Participants will receive behavioral weight loss intervention
15760669|NCT04771455|Behavioral|Intervention component: Decrease overvaluation of weight and shape|Participants will receive an intervention component to decrease overvaluation of weight and shape
15760670|NCT04771455|Behavioral|Intervention component: Decrease unhealthy weight control practices|Participants will receive an intervention component to decrease unhealthy weight control practices
15760671|NCT04771455|Behavioral|Intervention component: Decrease negative affect|Participants will receive an intervention component to decrease negative affect
15760672|NCT04771442|Drug|Stromal vascular fraction|Single dose
15760673|NCT04771416|Biological|PBKR03|Single dose of PBKR03, via intra cisterna magna
15760674|NCT04771403|Device|FMPD AP algorithm|The Fading Memory Proportional Derivative (FMPD) insulin infusion algorithm determines insulin delivery rates based on proportional error, defined as the difference between the current CGM level and the target CGM level, and the derivative error, defined as the rate of change of the CGM. The FMPD algorithm utilizes derivative and proportional glucose errors to determine delivery rates of insulin.
15760675|NCT04771403|Device|MPC AP system|The Model Predictive Control (MPC) insulin infusion algorithm contains a model within the controller that takes as an input the aerobic metabolic expenditure in addition to the CGM and meal inputs. The algorithm uses heart rate and accelerometer data collected on the patient's body to calculate metabolic expenditure. The metabolic expenditure then acts on the model for the insulin dynamics, whereby more energy expenditure and longer duration exercise can lead to a more substantial effect of insulin on the CGM.
15760676|NCT04771390|Drug|Selitrectinib (BAY2731954) Adult tablet|Tablet, oral administration
15760677|NCT04771390|Drug|Selitrectinib (BAY2731954) Pediatric tablet|Tablet, oral administration
15760678|NCT04771390|Drug|Selitrectinib (BAY2731954) Oral solution|Oral solution after reconstitution
15760679|NCT04771390|Drug|Selitrectinib (BAY2731954) Oral suspension|Oral suspension after reconstitution
15760680|NCT04771377|Dietary Supplement|Protein Supplementation|protein supplements will be supplied to participants at no cost physical activity Will be performed virtually by PT
15760681|NCT04771364|Other|ASAP care's protocol|Early geriatrician's advice, prefer locoregional anesthesia techniques where possible, early surgical therapy and medical adaptation on chronic patient's therapy (in particular with regard to sedative, anticholinergic and psychotropic drugs).
15760682|NCT04771351|Biological|COVI-AMG|COVI-AMG is a fully human SARS-CoV-2 neutralizing monoclonal antibody (mAb)
15760683|NCT04771351|Drug|Placebo|Diluent solution
15760684|NCT04771338|Behavioral|VR-JIT/KF-STRIDE|Treatment group will receive 12 sessions of job interview training protocol.
15760685|NCT04771325|Behavioral|Support from a trained companion|Birth companions trained on how to effectively support women during labor
15760686|NCT04771312|Behavioral|Mobile app information-only intervention|Mobile app intervention. Participants view information regarding PrEP that address beliefs and barriers surrounding adoption and uptake. Participants can respond to daily questions in a diary. Participants can also use a locator tool to find where PrEP can be found near them.
15760687|NCT04771312|Behavioral|Mobile app social support network intervention|Mobile app intervention. Participants view information regarding PrEP that address beliefs and barriers surrounding adoption and uptake. Participants are shown an online chatting tool where they can discuss with each other and answer daily questions. Participants can also use a locator tool to find where PrEP can be found near them.
15760688|NCT04771299|Drug|Cariprazine|Cariprazine is a novel atypical antipsychotic medication that has been approved by the Food and Drug Administration (FDA) for treatment of schizophrenia, manic or mixed, and depressive episodes associated with bipolar I disorder.
15760689|NCT04771299|Other|Placebo|Placebo is an inactive substance that looks identical to the study medication that contains no therapeutic ingredient.
15760690|NCT04771286|Drug|BI 1015550 (C-14)|BI 1015550 (C-14)
15760693|NCT04771247|Procedure|Cardia Band Ligation|Patients will undergo cardia band ligation at the level of the GEJ.
15760694|NCT04771234|Behavioral|Digital self-guided CBT-i|A brief version of CBT-i consisting of brief psychoeducation, and the core components sleep restricion and stimulus control, where sleep restriction is based on a simplified sleep diary.
15760695|NCT04771221|Diagnostic Test|pH metry|The collection of mucus from the laryngopharynx to determine the acid-base values through pH-metry.
15760696|NCT04771221|Diagnostic Test|Filling out the questionnaire|Completion of the questionnaire index of reflux symptoms. An analysis of the results of the effectiveness of this method in patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching will be carried out. Evaluation results range from 0 to 5, where 0 is an indicator of no problem, and 5 is an indicator of a serious problem
15760697|NCT04771221|Device|Endoscopic laryngoscopy|Video laryngoscopy and assessment of the presence / severity of the symptoms. Evaluation results range from 0 to 4, where 0 is an indicator of no problem, and 4 is an indicator of a serious problem
15760698|NCT04771208|Behavioral|"I kua na'u Let Me Carry Out Your Last Wishes"|A combination of Native Hawaiian advance care planning video decision support tool and personalized video declarations shared with providers and family members.
15760699|NCT04771169|Other|vestibular Training Group|this Group will receive vestibular Adaptation & Balance exercises
15760700|NCT04771169|Other|Virtual Reality Group|This Group will receive Virtual Reality Training by using exergaming.
15760701|NCT04771156|Drug|Ketorolac|Ketorolac 0.5mg/kg will be administered intra-operatively at the conclusion of the case and 3 more doses scheduled every 8 hours in the first 24 hours post-operatively for a total of 4 doses of Ketorolac
15760702|NCT04771156|Drug|Placebo|0.9% Normal Saline will be administered intra-operatively at the conclusion of the case and 3 more doses scheduled every 8 hours in the first 24 hours post-operatively for a total of 4 doses of normal saline.
15760703|NCT04771143|Drug|AFQ056|oral administration
15760704|NCT04771143|Drug|Placebo|matching placebo for oral administration
15760705|NCT04771130|Drug|BGB-11417|Oral administration for 10 or 28 days on a 28-day cycle.
15760706|NCT04771130|Drug|Azacitidine|Intravenous or subcutaneous administration for 7 days.
15760707|NCT04771130|Drug|Posaconazole|Oral administration for 10 days on second cycle only.
15760708|NCT04771117|Behavioral|Fear of Covid-19 Scale|"The Fear of Covid-19 Scale (FCV-19S) is a questionnaire that evaluates fear of the global pandemic caused by the SARS-CoV-2. The FVC-19S consists of seven items, such as It makes me uncomfortable to think about coronavirus-19, I am afraid of losing my life because of coronavirus-19, and When watching news and stories about coronavirus-19 on social media, I become nervous or anxious, each with a five-point Likert scale of options. The participant is instructed to choose the option that best represents their perception about the statement presented. The maximum possible total is 35 points. The scale's authors indicate that the higher the score is, the higher is the level of the participants' fear of COVID-19."
15760709|NCT04771104|Dietary Supplement|Amino Acid Challenge (AAC)|The AAC contains 54 g banana flavoured amino acid mixture added 200-300 mL of water. The AAC simulates the composition of haemoglobin in approximately 400 mL of blood.
15760710|NCT04771091|Diagnostic Test|Mesure of head-perineum distance by transperineal ultrasound|A mesure of head-perineum distance by ultrasound will be realized at the beginning of maternal pushing efforts by a junior gynecologist
15760711|NCT04771078|Biological|Nonconforming idecabtagene vicleucel|Nonconforming idecabtagene vicleucel is to be administered to subjects after lymphodepleting chemotherapy.
15760712|NCT04771052|Other|COVID Rehabilitation Program for the Elderly (CORE)|In the intervention unit, two teams (core team: physiotherapists and service healthcare workers; specialized team: occupational therapist, registered dietician, social worker) are dedicated to the patients hospitalized in COVID-19 unit. To prevent malnutrition, caused by disease-associated inflammation, the Nutrition as Medicine program (prescribed small doses (30 or 60 mL; 2 kcal/mL) of oral nutrition supplement dispensed with medication pass, 1 to 4 times a day), has been systematically implemented (collective prescription). To improve muscle strength, balance and tissue oxygenation and concomitantly reduce immobilization and risk of falls, each patient has a private pedal exerciser, resistance elastic bands and free weights to perform a progressive, monitored and individualized rehabilitation program thrice a day.
15760713|NCT04771039|Other|reason for consultation|search in medical files for reasons for ophthalmology consultation, functional signs, clinical signs, treatment, characteristics of IBD
15760714|NCT04771026|Drug|Dexamethasone|Pre-operatively nebuliser dexamethasone 8mg prior to induction of anesthesia
15760715|NCT04771013|Biological|Thymic peptides|250 mg oral daily dose of lyophilized thymic peptides dissolved in 50 mL of water, administered with an empty stomach.
15760716|NCT04771000|Drug|Ambrisentan|Endothelin receptor antagonist
15760717|NCT04771000|Drug|Placebo|Placebo
15760718|NCT04770987|Other|lateral neck flexor endurance test|Individuals will maintain the head in a neutral position off the ground in sidelying for as long as possible.
15760719|NCT04770974|Other|Biomarkers and proteomics|Biomolecular, proteomic, metabolomic and spectroscopy characterization of urothelial bladder neoplasia, on a 3D culture model (organoid) obtained from bladder tumor tissue
15760720|NCT04770961|Procedure|Erector spinae plane catheter with 0.5% Ropivacaine|Ultrasound guided, right sided, ESP catheter inserted at the level of T5. 20 cc injection of 0.5% Ropivacaine is injected at the time of catheter placement. Postoperatively, a programmed intermittent bolus infusion of 0.2% Ropivacaine will be delivered via the ESP catheter.
15760721|NCT04770961|Procedure|Erector spinae plane catheter with saline|Ultrasound guided, right sided, ESP catheter inserted at the level of T5. 20 cc injection of saline is injected at the time of catheter placement. Postoperatively, a programmed intermittent bolus infusion of saline will be delivered via the ESP catheter.
15760722|NCT04770948|Device|19 gauge needle|EBUS-TBNA performed using 19G needle
15760723|NCT04770948|Device|22 gauge needle|EBUS-TBNA performed using 22G needle
15760724|NCT04770935|Drug|efanesoctocog alfa (BIVV001)|Pharmaceutical form:solution for injection Route of administration: intravenous injection
15760725|NCT04770909|Behavioral|Incentives for dietary self-monitoring and weight loss|Participants can earn up to $300 during the trial for achieving adequate dietary self-monitoring and weight loss
15760726|NCT04770909|Behavioral|Incentives for dietary self-monitoring|Participants can earn up to $300 during the trial for achieving adequate dietary self-monitoring
15760727|NCT04770909|Behavioral|Incentives for weight loss|Participants can earn up to $300 during the trial for achieving weight loss
15760728|NCT04770896|Drug|Atezolizumab|Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator.
15760729|NCT04770896|Drug|Lenvatinib|Lenvatinib will be administered once daily by mouth each day of every 21-day study treatment cycle. Participants with a baseline body weight of < 60 kg will receive a daily dose of 8 mg. Participants with a baseline body weight of ≥ 60 kg will receive a daily dose of 12 mg.
15760730|NCT04770896|Drug|Sorafenib|Sorafenib will be administered at a dose of 800 mg per day, i.e. two tablets of 200 mg swallowed by mouth twice daily (equivalent to a total daily dose of 800 mg) each day of every 21-day study treatment cycle.
15760731|NCT04770883|Behavioral|Internet based cognitive behavioral therapy.|Patients will receive iCBT for 10 weeks, divided into five successive steps. The iCBT will be guided by online therapists and emphasizes acceptance of symptoms through exposure training. Patients have to report that they have worked through a treatment step to get access to the next. Patients will be encouraged to work through steps 1-4 during the first half of the treatment and to spend the latter half on step 5, in which exposure exercises will be introduced. The treatment aims to break the vicious cycle between avoidance behavior, symptom severity and functional impairment.
15760732|NCT04770883|Dietary Supplement|Low FODMAP diet therapy|Patients will receive 10 weeks of standardized treatment with low FODMAP diet consisting of 3 stages: FODMAP restriction; FODMAP reintroduction and FODMAP personalization. These stages will be covered in at least three appointments by primary care dieticians in Region Örebro County.
15760733|NCT04770870|Device|Hintermann Series H3 Total Ankle Replacement System|Intervention will include receiving the FDA approved Hintermann Series H3 Total Ankle Replacement System, to include a tibial component, a polyethylene inlay, and a talar component.
15760734|NCT04770857|Other|Visual analogue scale|Post procedural pain assessment using the visual analogue scale (VAS) will be performed in patients undergoing ERCP
15760735|NCT04770844|Other|Acquisitions|"Three acquisitions of 1 hours during hospitalization will be realized:
~a few days after hospitalization,
~in the middle of the hospitalization,
~a few days before hospital discharge. The child will be lying on his back in a heated cradle and filmed with a specific camera. The signal will be obtained by 2k ZED 2 stereo camera in order to obtain a three-dimensional location of the child"
15760736|NCT04770818|Device|Modified Brostrum procedure with Internal Brace Augmentation|Open, anatomic repair of the anterior talofibular and calcaneofibular ligaments for lateral ankle stability with InternalBrace augmentation.
15760737|NCT04770818|Device|Modified Brostrum procedure|Open, anatomic repair of the anterior talofibular and calcaneofibular ligaments for lateral ankle stability
15760739|NCT04770792|Other|2% chlorhexidine gluconate with mineral trioxide aggregate.|2% chlorhexidine gluconate with mineral trioxide aggregate.
15760740|NCT04770792|Other|Mineral trioxide aggregate.|Mineral trioxide aggregate.
15760741|NCT04770779|Drug|Placebo Matching Mitapivat|Tablets
15760742|NCT04770779|Drug|Mitapivat|Tablets
15760743|NCT04770766|Other|Non-medical practitioners|All observational research activity in each cohort is related to the exposure of non-medical practitioners in the Emergency Department or Urgent Treatment Centre
15760744|NCT04770753|Drug|Placebo Matching Mitapivat|Tablets
15760745|NCT04770753|Drug|Mitapivat|Tablets
15760746|NCT04770740|Dietary Supplement|Vitamin K2 in the form of Menaquinone-7 (MK-7)|Patients will take three tablets of vitamin K2 menaquinone-7 (333mcg) per day. Patients taking vitamin K2 MK-7 will receive the total of 999mcg per day from day 1 until day 14 or discharge, whichever occurs earlier. All subjects can be treated with prophylactic or therapeutic heparin-based (heparin or any low-molecular weight heparin) anticoagulants, according to local hospital protocols. Provided by Kappa Bioscience.
15760747|NCT04770740|Dietary Supplement|Placebo|Patients will take three tablets of placebo containing only inactive ingredients per day, from day 1 until day 14 or until discharge, whichever occurs first. The placebo is provided by Kappa Bioscience.
15760748|NCT04770727|Behavioral|CBT workshop|The CBT based intervention for adolescents will include psychoeducation on food allergy and anxiety and also focus on providing skills, knowledge and support.
15760749|NCT04770714|Diagnostic Test|Breast MRI|Standard of Care Breast MRI
15760750|NCT04770714|Diagnostic Test|Contrast Enhanced Mammography|Standard of Care Contrast Enhanced Mammography
15760751|NCT04770701|Drug|Ahah Drug|"- Composition Ahah containing concentrated extracts of plants: Eclipta prostrata 200mg, dioscorea cirrhosa 200mg, phyllanthus urinaria 150mg, adenosma glutinosum 150mg, impatiens balsamina 75mg and ascorbic acid 250mg
~-Take 1tablet x 2 times / 24 hours. Maintained for 9 months."
15760752|NCT04770701|Device|Ahah Placebo|"- Composition Ahah (not containing concentrated extracts of plants): Eclipta prostrata 200mg, dioscorea cirrhosa 200mg, phyllanthus urinaria 150mg, adenosma glutinosum 150mg, impatiens balsamina 75mg and ascorbic acid 250mg)
~-Take 1tablet x 2 times / 24 hours. Maintained for 9 months."
15760753|NCT04770688|Drug|Osimertinib|Osimertinib, 80mg, QD, p.o.
15760754|NCT04770688|Drug|Anlotinib|"(Phase Ib) Anlotinib, from 8mg to10mg to 12mg, QD, p.o. from day 1 to 14 of a 21-day cycle.
~(Phase IIa)Anlotinib, given at RP2D dose QD, p.o. from day 1 to 14 of a 21-day cycle."
15760755|NCT04770675|Diagnostic Test|Bronchoscopy|All subjects who are scheduled for a bronchoscopy may be eligible.
15760756|NCT04770662|Other|Questionnaires|"Administered Questionnaires:
~Dutch version of Children's Yale-Brown Obsessive Compulsive Scale (CYBOCS, Goodman W.K. e.a.)
~Dutch version of Eating Disorder Inventory-3 (EDI-3, David M. Garner)
~General Questionnaire: demografic , scholar and social information and child psychiatric history
~Dutch version of the Child Behavior Checklist (CBCL, T.M. Achenbach)
~Anorectic Behavior Observation Scale (ABOS, Vandereycken W., Universitair Centrum Kortenberg, 1992)"
15760757|NCT04770649|Biological|COVID-19 vaccine|Any vaccine for COVID-19
15760758|NCT04770623|Drug|Docetaxel|patients with gastric cancer who have disease progression after first line treatment will receive the test protocol and evaluated for efficacy and survival
15760759|NCT04770623|Drug|Irinotecan|patients with gastric cancer who have disease progression after first line treatment will receive the test protocol and evaluated for efficacy and survival
15760760|NCT04770610|Drug|OT-101 Ophthalmic Solution|Atropine 0.01%
15760761|NCT04770610|Drug|Vehicle|Investigational Product minus active ingredient
15760762|NCT04770597|Device|Aranet4 Home CO2 monitor|The sensor is placed in the room at a height between 1 and 2 meters and not near the window or door.
15760763|NCT04770584|Other|Fear Conditioning|Participants will be administered increasing intensities of mild electric shock via electrodes connected to the foot. New Biopac stimulators that can deliver higher shock intensity, provided participants agreement will be used to assure adequate conditioning levels. Stimulation is measures in milliamps (mA), and each delivered stimulation will be 0.5 seconds long (500 milliseconds). To colored (blue, red, & yellow) light stimuli (CS). The light stimulus is followed by a shock or no shock depending on color (blue & red - shock; yellow - no shock).
15760764|NCT04770584|Other|Avoidance conditioning|Via button pressing. Only one stimulus-CS (i.e. blue colored light) will enable control over experiencing the shock: the participant can press the button during the first 2 seconds of the light presentation to avoid the shock. CS stays on for 6 seconds after the button is pressed. If the button is pressed, no shock will be administered. After 6 seconds, the light ends and the relief epoch ('good feeling') begins. Pressing the button to the other CS (i.e. red colored light) will not prevent the shock from occurring- the participant will still receive the mild shocked at CS offset (after 6 seconds). The third CS (i.e. yellow light) will serve as a control CS, so while the button is available, pressing it or not is of no consequence.
15760765|NCT04770584|Other|Pavlovian fear extinction learning|After avoidance conditioning, the CS+ associated with avoidance responding (i.e. blue light) appears with no button to press and no shock is administered.
15760766|NCT04770584|Other|Willingness to pay to avoid shock|"On the next day, participants receive a monetary stipend to use to pay to guarantee that they are not to receive any shocks if they press a button from the CS+. No shocks will be delivered on day 2, regardless of money paid.
~This and all previously described experimental phases noted above will occur inside of the fMRI scanner."
15760767|NCT04770558|Other|Interactive Exergame|The one-to-one supervised training session consists of 10 min warm-up exercise, 40 min interactive exergame, and 10 min cool-down exercise. Both physical (muscle strength, coordination and balance in lower limbs) and cognitive functions (visuospatial, attention, short-term memory, calculation, reaction and executive function) will be trained through the interactive exergame.
15760768|NCT04770545|Drug|PEGCETACOPLAN (APL-2)|Complement (C3) Inhibitor
15760769|NCT04770532|Drug|Insulin degludec|Participants will receive subcutaneous (s.c.) injections of insulin degludec once daily for 26 weeks
15760770|NCT04770532|Drug|Insulin Icodec|Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 26 weeks
15760771|NCT04770519|Genetic|whole genome sequencing|Whole genome sequencing will be performed for all enrolled participants.
15760772|NCT04770506|Other|Data extraction from medical files|Data extraction from medical files
15760775|NCT04770480|Behavioral|Standard Care (SC)|No attempt will be made to change usual care practice after surgery
15760776|NCT04770480|Behavioral|Enriched Pain Management Pathway (EPM)|Enriched Pain Management Pathway will be delivered by physical therapists trained to integrate physical therapy and mindfulness techniques grounded in a biopsychosocial context. The intervention will be delivered within the context of the post-operative physical therapy routine (the mindfulness approach will be integrated into the post-operative physical therapy care).
15760777|NCT04770467|Drug|BRII-196 and BRII-198|BRII-196 and BRII-198 given by intravenous administration
15760778|NCT04770467|Drug|Placebo|Placebo given by intravenous administration
15760780|NCT04770428|Drug|MEDI7352|A dose of MEDI7352 will be administered as two 1.5 mL injections in the abdomen. Following an overnight fast of at least 8 hours, each participant will receive a single dose of MEDI7352 on 4 occasions.
15760781|NCT04770428|Drug|Placebo|Matching placebo will be administered as two 1.5 mL injections in the abdomen. To maintain the double-blind requirements, the placebo volume administered will be equivalent to the MEDI7352 volume administered for each dosing. Following an overnight fast of at least 8 hours, each participant will receive matching placebo on 4 occasions.
15760782|NCT04770402|Other|Acupuncture|12 acupuncture sessions over 10 weeks
15760783|NCT04770402|Other|Standard of Care CIPN management|Investigator directed standard of care management of CIPN
15760784|NCT04770389|Drug|Obicetrapib 5mg|tablet
15760785|NCT04770389|Drug|Ezetimibe 10mg|tablet
15760786|NCT04770389|Other|Placebo|tablet
15760787|NCT04770376|Other|Observational study. Blood samples will be collected at scheduled blood draws performed as per clinical practice before each cycle of chemotherapy.|Collection of blood samples during blood draws performed before each cycle of chemotherapy as per clinical practice.
15760788|NCT04770363|Device|Transcranial Direct Current Stimulation (tDCS)|Transcranial direct current stimulation (tDCS) is an emerging non-invasive brain stimulation technique which has been utilized in examining cortical function in healthy subjects and also showed significant outcome in neurological rehabilitation. A safe, portable, noninvasive painless, reversible, selective and focal brain stimulation technique, applied by sponge electrodes over the scalp. tDCS is capable of modulating the excitability of targeted brain zones through delivering a sustained direct current (DC), showed altering neuronal membrane potentials based on the polarity of the current. Researchers demonstrated modulating effects of anodal (increases cortical excitability) and cathodal (decreases cortical excitability) tDCS on brain tissue. The expected effects of tDCS brain stimulation exceeds the duration. Animal studies showed neuronal depolarization and increasing neuronal excitability of the anodal stimulation, and opposite results with cathodal stimulation.
15760789|NCT04770350|Device|Focused Ultrasound|The DWL Doppler ultrasound device enables visual and auditory waveform confirmation of the middle cerebral artery, and optical tracking technology (e.g., AntNeuro Visor2™ system) may be used in tandem with the Brainsonix ultrasound device to track a patient's brain in virtual space as well as their physical location, thereby ensuring accurate placement.
15760790|NCT04770337|Device|STARSTIM device|Cathodal Transcranial Direct Current Stimulation (tDCS). Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current delivered to the brain area of interest via electrodes on the scalp.
15760791|NCT04770337|Device|Sham Device|Intervention which uses enough currents to generate a sensory feedback similar to that of active stimulation via electrodes on the scalp
15760792|NCT04770324|Device|Interposition supraciliary implant|Surgical placement of 2 interposition supraciliary implant in the supraciliary space
15760793|NCT04770311|Behavioral|Microbiome friendly diet|Families in the intervention group will have a microbiome-friendly nutrition assessment and will also receive groceries one time per week for four weeks to help achieve a more microbiome-friendly diet.
15760794|NCT04770298|Other|Halliwick Concept|Halliwick Concept: Water intervention Bobath Concept: Neurodevelopmental Treatment
15760795|NCT04770285|Device|MIRAI Depression Study Digital Therapetic|Two different versions of the MIRAI Depression Study digital therapeutics will be compared.
15760796|NCT04770272|Drug|Atezolizumab 840 MG in 14 ML Injection|840 mg Day 1 for two weeks
15760797|NCT04770272|Drug|Atezolizumab 1200 MG in 20 ML Injection|1200 mg Day 1 every 3 weeks for 8 cycles
15760798|NCT04770272|Drug|Carboplatin|Dosing according to Area Under the Curve of 2 Intravenous weekly x 12 cycles
15760799|NCT04770272|Drug|Paclitaxel|Paclitaxel 80 mg/m² IV weekly x 12 cycles
15760800|NCT04770272|Drug|Epirubicin|90 mg/m2, day 1 for 4 cycles (12 weeks)
15760801|NCT04770272|Drug|Cyclophosphamide|600 mg/m2, day 1 for 4 cycles (12 weeks)
15760802|NCT04770272|Procedure|Biopsy Arm A|1st Biopsy two weeks after Baseline visit. 2nd Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 3rd Biopsy with tumor size greater 10 mm in diameter.
15760803|NCT04770272|Procedure|Biopsy Arm B|1st Biopsy after two weeks of Carboplatin + Paclitaxel + Atezolizumab therapy. 2nd Biopsy with tumor size greater 10mm in diameter.
15760804|NCT04770272|Procedure|Surgery|After completion of 27-28 weeks (Arm B) or 29-30 weeks (Arm A) of neoadjuvant treatment, surgery is planned for all patients.
15760805|NCT04770259|Other|Timely pre-surgical conditioning|Timely pre-surgical conditioning seeks to prepare frail, pre-frail and / or dependent older patients for the surgery process. For which a work plan has been designed according to your needs and health conditions.
15760810|NCT04770233|Procedure|Early ACL reconstruction|ACL reconstruction followed by rehabilitation
15760811|NCT04770233|Procedure|Active rehabilitation|Non-operative treatment with active rehabilitation led by a physiotherapist with optional delayed surgery if indicated.
15760814|NCT04770207|Drug|Injection of drug-eluting microspheres into malignant tumors|Under the guidance of CT, puncture needle was used to inject drug-eluting microspheres into the tumor
15760815|NCT04770194|Drug|SP-8008 Prototype Capsule A|Oral
15760816|NCT04770194|Drug|SP-8008 Prototype Capsule B|Oral
15760817|NCT04770194|Drug|Placebo|Oral
15760818|NCT04770181|Device|Alpha-Stim AID CES (Active Comparator)|The Alpha-Stim® AID CES device delivers a mild electrical current (100-500 µA) to the brain via ear clips electrodes. The treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks at 0.5 Hz. 50% duty cycle with a fixed current of 100 µA (subsensory level).
15760819|NCT04770181|Device|Alpha-Stim AID CES (Sham Comparator)|The Alpha-Stim® AID CES sham device is inactive and does not emit electrical current to the brain via ear clip electrodes. The sham treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks.
15760820|NCT04770168|Behavioral|Cognitive Behavioral Therapy Curriculum|"The 3-month Harry Potter curriculum is delivered by trained teachers and includes lessons on a) risk factors that can contribute to emotional distress, b) how depression and anxiety manifest and how to access support/treatment, c) cognitive distortions, how they differ from rational thoughts and basic cognitive restructuring techniques, d) crisis planning including personalized stressbusters and hope kits, and e) how to be resilient."
15760821|NCT04770155|Dietary Supplement|Dietary Nitrates 400 mg|The nitrates in the beetroot juice will be absorbed and reduced in the plasma to nitrite and nitric oxide, increasing endothelium-independent nitric oxide bioavailability.
15760822|NCT04770155|Dietary Supplement|L-citrulline 3 g|Ingested L-citrulline becomes available in large quantities in the plasma for enzymatic conversion into L-arginine. The activity of the endothelial nitric oxide synthase converts L-arginine into nitric oxide, increasing endothelium-dependent nitric oxide bioavailability.
15760823|NCT04770155|Drug|Sildenafil 100 mg|Sildenafil inhibits phosphodiesterase 5, an enzyme that degrades cyclic guanosine monophosphate in the vascular smooth muscle cells inactivating the nitric oxide-mediated signal; thus, Sildenafil will prolong the availability of cyclic guanosine monophosphate, enhancing the nitric oxide-mediated intracellular cascade.
15760824|NCT04770155|Drug|Bosentan 125 mg|Bosentan blocks endothelin-1 receptors ETA and ETB, leading to a reduction in vasoconstrictor tone and a greater magnitude of vasodilator responses.
15760825|NCT04770142|Device|TIRA catheter|treat hypertrophic obstructive cardiomyopathy
15760826|NCT04770116|Device|Auditory Stimulation|The device records biosignals and precisely plays tones to enhance sleep slow waves.
15760827|NCT04770103|Behavioral|Balance recovery|"Balance recovery by stepping ascertains the capability of the participant to recover when subjected to a loss of balance in the forward direction.
~Attitudes towards exercise, fear of falling and mental wellness a psychosocial measures to ascertain the relationship between perceptions and physical capability."
15760828|NCT04770103|Behavioral|Postural Sway|"Postural sway is a pseudo-static measure of postural control that evaluates a participants balance recovery ability when the perturbation does not require a dynamic step recovery.
~Attitudes towards exercise, fear of falling and mental wellness a psychosocial measures to ascertain the relationship between perceptions and physical capability."
15760829|NCT04770090|Other|Blood samples|Peripheral blood samples at the beginning of surgery, after pneumoperitoneum creation and uterine pedicles coagulation.
15760830|NCT04770077|Other|Intubation on manikin|Training of medical student to focus on manikin vocal cord before intubation
15760831|NCT04770064|Drug|High-dose/short-duration Fisetin|Fisetin is a plant flavanol senolytic found in strawberries, persimmons, and cucumbers. It has senolytic properties that may provide therapeutic benefit for those with knee osteoarthritis. Participants will be asked to take approximately 20 mg/kg of body mass for 2 consecutive days, followed by a 28-day washout period, and then another 2-day administration.
15760832|NCT04770064|Drug|Low-dose/sustained-duration Fisetin|Fisetin is a plant flavanol senolytic found in strawberries, persimmons, and cucumbers. It has senolytic properties that may provide therapeutic benefit for those with knee osteoarthritis. Participants will be asked to take one, 100 mg capsule of fisetin daily for 90 days.
15760833|NCT04770064|Other|Oral placebo capsule|Participants will be asked to take one, 100 mg oral placebo capsule (corn starch) daily for 90 days.
15760834|NCT04770051|Procedure|Percutaneous inferior cervical sympathetic block|The procedure will be performed while the patient was awake and under fluoroscopic guidance. A total of 3 ml of 1% lidocaine will be infiltrated to anesthetize the skin and subcutaneous tissues down to the left common carotid artery. A 22 gauge × 3.5 inch BD™ Quincke spinal needle will be introduced at the level of the body of the sixth cervical vertebra, medial to the left common carotid artery. The needle will be advanced until it reached the junction between the body and transverse process of the sixth cervical vertebra. Contrast injection will be used to demonstrate the position of the needle anterior to the paravertebral muscles, with spread along the axis of the interfascial compartment (Figure 1). A total of 20 ml of 0.25% bupivacaine (Marcaine, Hospira, Lake Forest, IL) will be injected over 10 min through the needle. The effectiveness of sympathetic blockade will be confirmed by postprocedure development of ptosis and miosis in the left eye.
15760835|NCT04770038|Behavioral|Dialectical Behavior Therapy (DBT)|Evidence-based psychotherapy for the treatment of Borderline Personality Disorder
15760836|NCT04770025|Device|High-density transcranial alternating current stimulation|High-density electrode configuration with transcranial alternating current stimulation in the beta (15-40Hz) frequency range
15760837|NCT04770025|Device|Sham stimulation|High-density electrode configuration with sham stimulation
15760838|NCT04770025|Behavioral|Motivational interviewing|Motivational interviewing session focused on alcohol use, approximately 30 minutes in length
15760839|NCT04770012|Drug|Placebo|patients randomized to placebo study group will be dispensed placebo capsules to be taken daily for the duration of the treatment
15760840|NCT04770012|Drug|aspirin|patients randomized to aspirin study group will be dispensed aspirin capsules to be taken daily for the duration of the treatment
15760841|NCT04770012|Drug|Clopidogrel|patients randomized to clopidogrel study group will be dispensed clopidogrel capsules to be taken daily for the duration of the treatment
15760842|NCT04769999|Behavioral|Simple cognitive task|A brief memory reminder cue followed by playing the computer game Tetris for 25 minutes using mental rotation instructions. Option for subsequent booster sessions (self-administered/researcher-assisted).
15760843|NCT04769986|Behavioral|Mobile Mindfulness-Relapse Prevention (mMBRP)|Mindfulness Coach 2.0 is a mobile application designed by the VA's National Center for PTSD. The app provides: (a) psychoeducational topics related to mindfulness; (b) audio-guided mindfulness exercises; (c) self-assessment using the Five Facet Mindfulness Questionnaire (d) a journal to track mindfulness practice sessions; (e) goal setting and tracking; (f) personal, customizable reminders; and (g) immediate access to support and crisis resources. We will enhance Mindfulness Coach with MBRP content by adding information about the triangle of awareness to understand connections among thoughts, sensations, and emotions, and specific meditations of sober breathing space and urge surfing to deal with cravings. We will add additional MBRP-specific modules. Participants will be asked to complete the intervention during 8 weeks, with two to three modules per week. After a beta test with 20 veterans, feedback will be used to refine the app for the national randomized clinical trial (RCT).
15760844|NCT04769986|Behavioral|Exercise/healthy eating mobile app|Participants in the control condition will be asked to download an exercise/healthy eating mobile app and use it for 8 weeks. Similar to Mindfulness Coach, the app will have specialized self-management guides that follow a guide-per-week format, educational videos that teach diet and exercise strategies, and a diary to track diet and exercise progress.
15760845|NCT04769960|Diagnostic Test|MRI Studies|MRI scans will be performed on a 1.5T MRI scanner. Department of Radiology MRI SafetyGuidelines will be followed except regarding breast tissue expanders. Conventional MRIstudies will be performed using the standard of care clinical sequences.
15760846|NCT04769960|Behavioral|Patient Reported Outcomes|Participants will fill out questionnaires before, immediately after, and approximately 3 months following the MRI examination +/- 1 month to evaluate for any pain or perceived changes with the breast tissue expander. The first questionnaire will obtain background participants information as well as establish a baseline pain level, the second questionnaire will evaluate any changes in pain after undergoing the MRI examination, and the last questionnaire will evaluate long term changes in pain.
15760847|NCT04769934|Device|Penguin RFA|to evaluate the peri-implant bone level changes (marginal bone level) around the implant platform.
15760848|NCT04769921|Device|dental implants and abutments from Nobel Biocare|The implants will be inserted in an All-on-4 configuration; Abutments will be connected to the implants and serve as support for a full-arch implant-supported restoration.
15760849|NCT04769908|Drug|Systemic Chemotherapy|Systemic Chemotherapy (Oxaliplatin#5-fluorouracil and leucovorin)
15760850|NCT04769908|Drug|Lenvatinib|Lenvatinib, 8mg or 12mg, po, QD
15760851|NCT04769908|Drug|Sintilimab|Sintilimab, IV, 200mg, q3w
15760852|NCT04769895|Drug|MaaT013|MaaT013 is made of allogeneic, full-ecosystem pooled biotherapeutic intestinal microbiota
15760853|NCT04769882|Device|Er:YAG Laser|"Selected Er:YAG settings: enamel removal program for adult, with normal modality (frequency: 20 Hz, energy: 400 mJ, power: 8.0 W, air: 80%, water: 60%) and dentin removal program for adult, with normal modality (frequency: 20 Hz, energy: 200 mJ, power: 4.0 W, air: 90%, water: 30%)"
15760854|NCT04769869|Drug|AZD4604 for inhalation via DPI|Healthy volunteers will receive AZD4604 administered with a DPI. The dose is expected to be administered between 10 to 45 minutes, depending upon dose. The dose will be administered after an overnight fast of at least 10 hours. Healthy volunteers will be allowed to drink water to prevent dehydration until 1 hour before dosing.
15760855|NCT04769869|Drug|Placebo for AZD4604 for inhalation via DPI|"Part 1a: An additional cohort of healthy volunteers will receive a placebo administered with a DPI.
~Part 2: Healthy volunteers will receive placebo administered with a DPI. They will receive BID doses on Day 1 to Day 6, and a single dose will be administered on Day 7."
15760856|NCT04769869|Drug|AZD4604 for IV administration|Healthy volunteers will receive a single IV dose of AZD4604 administered over 20 minutes. The dose will be administered after an overnight fast of at least 10 hours. Healthy volunteers will be allowed to drink water to prevent dehydration until 1 hour before dosing.
15760857|NCT04769869|Drug|AZD4604 for oral administration|Healthy volunteers will receive a single PO dose of AZD4604. The dose will be administered after an overnight fast of at least 10 hours. Healthy volunteers will be allowed to drink water to prevent dehydration until 1 hour before dosing.
15760858|NCT04769856|Other|State-Trait Anxiety Inventory (STAI) scale|State-Trait Anxiety Inventory (STAI) scale
15760859|NCT04769856|Other|Satisfaction scale|Satisfaction scale
15760860|NCT04769830|Other|Bowel sound|The characteristic data of bowel sounds, such as 24-hour average intestinal rate, duration of gastrointestinal sounds, amplitude, maximum frequency and average frequency, were collected to observe the differences of intestinal sounds among different AGI grades.
15760861|NCT04769817|Other|177Lu-PSMA|Lu-PSMA will be administered as a standard-of-care procedure following assessment of suitability by a nuclear medicine physician and managed in close collaboration with the patient's medical oncologist.
15760862|NCT04769791|Device|intracuff pressure measurement|intracuff pressure is measured by a pressure manometer
15760863|NCT04769791|Device|intracuff pressure measurement|intracuff pressure is measured by a pressure manometer
15760864|NCT04769791|Device|intracuff pressure measurement|intracuff pressure is measured by a pressure manometer
15760865|NCT04769778|Drug|Valsartan 80Mg Oral Tablet|treatment with 80mg /day of valsartan
15760866|NCT04769765|Other|Definition of the Individualized Care Pathway|Implementation of an individualized care pathway defined in concertation with a multidisciplinary tele-expertise meeting held every 3 months for one year. These multidisciplinary tele-expertise meetings will be held between each of the normal routine consultations which are part of the normal, basic diabetic program which includes a consultation with a dietitian, monitoring by a state-registered nurse and treatment prescribed by the patient's general practitioner (with or without a consultation with the clinical pharmacist).
15760867|NCT04769752|Other|collection of the allocated treatment|collection of the allocated treatment
15760868|NCT04769752|Other|collection of medical complications|collection of medical complications
15760869|NCT04769739|Other|CO2|using CO2 insufflation to help insertion
15760870|NCT04769739|Other|Water|using water instead of traditional gas to help insertion
15760871|NCT04769739|Other|50% saline|using 50% saline solution instead of traditional gas to help insertion
15760872|NCT04769739|Other|25% saline|using 25% saline solution instead of traditional gas to help insertion
15760873|NCT04769726|Dietary Supplement|almonds|almond intervention (25% of total energy) for 3 months
15760874|NCT04769713|Procedure|Hepatic Hilar Nerve Block Needle placement|Placement of a needle within 2cm of the portal vein bifurcation along its anterior surface for injection of nerve block agent (for nerve block) or saline (placebo) under US or CT guidance.
15760875|NCT04769713|Drug|Injection of Ropivacaine in the hepatic hilum for the hepatic hilar nerve block|Injection of 15 ml 0.5% Ropivacaine at the hepatic hilum along the anterior surface of the portal vein within 2cm of the bifurcation.
15760876|NCT04769713|Drug|Injection of normal saline in the hepatic hilum for the sham procedure|15 ml sterile normal saline is injected at the hepatic hilum along the anterior surface of the portal vein within 2cm of the bifurcation.
15760909|NCT04769453|Device|Ab-interno canaloplasty using the iTrack surgical system with Healon Pro|360 degree microcatheterization and viscodilation of Schlemm's canal
15761204|NCT04766996|Drug|Baby aspirin|Baby aspirin 81mg: Twice daily for 6 weeks after surgery
15760877|NCT04769700|Behavioral|Edinburgh Postnatal Depression Scale|The Edinburgh Postnatal Depression Scale is a self-administered questionnaire made up of 10 items scored using a four-point Likert scale (0-3) designed to screen for symptoms of postpartum depression. Postpartum depression represents the end of a continuum of severity of symptoms. The present study used a cutoff point for depressive symptomatology risk of higher than 12.
15760878|NCT04769700|Behavioral|Breast Feeding Adherence|This will be addressed according to the breastfeeding initiation practices according to the WHO.
15760879|NCT04769700|Behavioral|Fear of Covid-19 Scale|The Fear of Covid-19 Scale is a questionnaire that evaluates fear of the global pandemic caused by the SARS-CoV-2. It consists of seven items, each with a five-point Likert scale of options. The participant is instructed to choose the option that best represents their perception about the statement presented. The maximum possible total is 35 points. The scale's authors indicate that the higher the score is, the higher is the level of the participants' fear of COVID-19.
15760880|NCT04769687|Biological|probiotic Vivomixx®|Vivomixx® is in powder form packaged in sachets of 4.5.1011 bacteria. The dose used is 2 sachets per day (morning and evening) for 8 weeks (56 days). For the study, the symbiotics will be packaged in the same sachet at the same doses as mentioned above.
15760881|NCT04769687|Biological|prebiotic Orafti®Synergy1|Orafti®Synergy1 is a slightly sweet white powder packaged in 5 g sachets. The dose used is 2 sachets per day (morning and evening) for 8 weeks (56 days).
15760882|NCT04769687|Other|Placebo|Placebo
15760883|NCT04769674|Other|Sensory Integration Intervention through the STAR Frame of Reference|The individualized therapy program will be based on the results of the comprehensive evaluation. Intervention aligns with the STAR Frame of Reference fidelity measure and Ayres Fidelity Measure.
15760884|NCT04769661|Diagnostic Test|Cytokines|Doing cord blood cytokines level in preterm infants
15760885|NCT04769648|Drug|Pro-ocular™ Topical Gel 1%|Pro-ocular™ is a topical gel applied dermally to forehead twice-daily
15760886|NCT04769648|Drug|Placebo|Placebo is a vehicle topical gel without active ingredient applied dermally to forehead twice-daily
15760887|NCT04769635|Device|CPAP therapy|All studied patients were received CPAP therapy with average cumulative adherence ⩾4 h/day of >70% nights [380] obtained from device download with AHI<5 /hr
15760888|NCT04769622|Procedure|Non-surgical periodontal treatment|all included patients will be subjected to non-surgical periodontal therapy
15760889|NCT04769622|Other|Questionnaires|"All patients will be asked to complete a set of questionnaires regarding:
~adherence to Mediterranean Diet;
~sleep quality;
~physical activity;
~perceived stress."
15760890|NCT04769609|Device|bioresorbable membrane|reconstructive surgical treatment of peri-implant bone defects
15760891|NCT04769583|Drug|metronidazole based quadriple therapy|patient randomized in QC will be treated by a double dose PPI (esomeprazole: 40 mg x 2 per day) in combination with amoxicillin (1 g x 2 per day), metronidazole (500 mg x 2 per day) and clarithromycin (500 mg x 2 per day)
15760892|NCT04769583|Drug|placebo based quadriple therapy|patient randomized in TT will be treated by double dose PPI (esomeprazole: 40 mg x 2 per day) in combination with amoxicillin (1 g x 2 per day), clarithromycin (500 mg x 2 per day) and a placebo of metronidazole.
15760893|NCT04769570|Procedure|interscalene brachial plexus block|Single shot ultrasound guided interscalene brachial plexus block will be performed preoperatively to patients.Patient-controlled analgesia (PCA) with morphine will be used for postoperative analgesia.
15760894|NCT04769570|Procedure|suprascapular nerve block|Single shot ultrasound guided interscalene brachial plexus block and Suprascapular nerve block will be performed preoperatively to patients.Patient-controlled analgesia (PCA) with morphine will be used for postoperative analgesia.
15760895|NCT04769570|Procedure|Group Control|consist of the patient group without any procedure.
15760896|NCT04769557|Drug|paracetamol|tablet paracetamol 500 mg
15760897|NCT04769557|Drug|Placebo|placebo
15760898|NCT04769544|Device|total knee arthroplasty with medial pivot tibial insert or symmetrical insert|standard surgical implantation of total knee arthroplasty
15760899|NCT04769531|Other|Hip Joint Mobilizations|i. Anterior-posterior glide ii. Posterior-anterior glide iii. Caudal glide iv. Posterior-anterior glide with Abduction, flexion, and lateral rotation
15760900|NCT04769531|Other|Hip joint Muscle strength training|i. Hip abduction in side-lying ii. Hip extension in the prone position iii. Sideways walk iv. Hip abduction in stand up position v. Hip hitching
15760901|NCT04769531|Other|knee strengthening and flexibility exercises|"i. STRENGTHENING EXERCISES: Knee extension static quads set, terminal knee extension while standing up, sitting leg press, partial squat, step-ups.
~ii. STRETCHING EXERCISES:: stretching of the calf, hamstring, and quadriceps-femoris.
~iii. RANGE OF MOTION EXERCISES: Knee in mid-flexion to full-extension, Knee in mid-flexion to full-flexion:"
15760902|NCT04769518|Procedure|Advanced Recovery Room Care (ARRC)|High acuity care
15760903|NCT04769505|Behavioral|digital mindfulness-based intervention (MBI)|The digital MBI consists of four auditory guided mindfulness exercises lasting between 10 and 15 minutes. The four exercises are a body scan and three sitting meditations (awareness of the heartbeat, awareness of the body, awareness of sounds). The exercises can be conducted via a software on participants' smartphones. Participants will be familiarized with the concept of mindfulness and the intervention in a single face-to-face introductory session. Additionally, participants will receive a manual, containing all relevant information. Participants will be instructed to practice at least once daily over the course of eight weeks, either in the morning or in the evening, and additionally whenever they desire to. They can choose individually between the exercises.
15760904|NCT04769492|Other|#ChopViolence/#ChopHIV|Tailored, community-based violence prevention intervention
15760905|NCT04769479|Drug|acoramidis|acoramidis
15760906|NCT04769466|Other|LifeBio Memory|LifeBio Memory is a digital reminiscence therapy platform designed to collect the life stories of older adults to generate personalized life storybooks that capture their unique narratives and social histories. Life story booklets, summaries, and materials are also developed as mechanisms for sharing this story and for staff to provide enhanced person-centered care.
15760907|NCT04769453|Device|ab-interno canaloplasty using the iTrack surgical system with Healon GV Pro|360 degree microcatheterization and viscodilation of Schlemm's canal
15760908|NCT04769453|Device|Ab-interno canaloplasty using the Omni surgical system with Healon GV Pro|360 degree microcatheterization and viscodilation of Schlemm's canal
15761273|NCT04766463|Drug|SHR8554 Injection|SHR8554 Injection; low dose
15760910|NCT04769453|Device|Ab-interno canaloplasty using the Omni surgical system with Healon Pro|360 degree microcatheterization and viscodilation of Schlemm's canal
15760911|NCT04769440|Drug|mg sulphate|mgso4 infusion will start 15 minutes after intubation , 30 mg/kg LBW of 10%mgso4 in 100 ml normal saline I.V ,over 30 minutes followed by 10 mg/kg LBW for 90 minutes
15760912|NCT04769427|Device|PDO max threads|To determine the effects of absorbable Polydioxanone (PDO) thread non-surgical rhinoplasty on quality of life (FACE-Q scale)
15760913|NCT04769414|Drug|Gemcitabine fluorouracil|"chemotherapy protocol given as:
~Gemcitabine 1000mg/m2 IV short infusion
~Leucovorin 400 mg/m2 IV short infusion
~Flourouracil 400 mg/m2 direct IV shot
~Flourouracil 2000 mg/m2 contineous infusion over 46 hours
~The whole regimen will be repeated bi-weekly"
15760914|NCT04769401|Drug|Progesterone|Progesterone supplementation was initiated by the use of 100 mg of a vaginal progesterone tablet two times daily (Lutinus, Ferring Pharmaceuticals) plus 250 mg of intramuscular hydroxyprogesterone caproate in oil twice a week (IMHPC) or 25 mg/d of SC progesterone daily (Prolutex) as luteal phase support (referred to as day 0 of progesterone administration).
15760915|NCT04769388|Drug|Osimertinib|Pemetrexed (500 mg/m2) plus carboplatin (AUC5) on Day 1 of 21day cycles (every 3 weeks) for up to 6 cycles, followed by Osimertinib daily with pemetrexed maintenance (500 mg/m2) every 3 weeks.
15760916|NCT04769388|Drug|Pemetrexed/Carboplatin|Pemetrexed (500 mg/m2) plus carboplatin (AUC5) on Day 1 of 21day cycles (every 3 weeks) for up to 6 cycles, followed by Osimertinib daily with pemetrexed maintenance (500 mg/m2) every 3 weeks.
15760917|NCT04769375|Other|Evaluation of pain|The presence of pain localization pelvic girdle pain will be questioned in the body chart. Inaddition to this, the level of the pelvic girdle pain will be evaluated by visual analog scale.
15760918|NCT04769375|Other|Application of pelvic girdle pain tests|The tests will be applied sequentially to investigate the presence and severity of the pain (Tests: Posterior Pelvic Pain Provocation, Patriarch FABER, Long Dorsal Sacroiliac Ligament Pain Provocation, Simpsis Palpation, Modified Trendelenburg and Active Straight Leg Raise)
15760919|NCT04769375|Other|Application of pelvic girdle questionnaire|Pelvic girdle questionnaire will be filled by pregnant women with pelvic girdle pain.
15760920|NCT04769362|Drug|Discontinuation of β-blocker|Discontinuation of β-blocker after at least 1 year of β-blocker therapy after acute myocardial infarction
15760921|NCT04769336|Device|Central Lab based CBC|lab samples will be sent to the central lab for CBC analysis
15760922|NCT04769336|Device|Point of Care CBC|lab samples will be analyzed at point of care
15760923|NCT04769323|Device|Virtual Reality|Vestibular rehabilitation is an exercise-based program, designed by a specialty-trained vestibular physical therapist, to improve balance and reduce problems related to dizziness.
15760924|NCT04769323|Other|Traditional home exercises|Vestibular rehabilitation is an exercise-based program, designed by a specialty-trained vestibular physical therapist, to improve balance and reduce problems related to dizziness.
15760925|NCT04769310|Device|Cardiac and Brain MRI|"A CMR to evaluate for LA and LAA high-risk features on either a 1.5 or 3 Tesla clinical MR scanner will be used. Gadolinium injection will be administered. Gadolinium is a contrast product that helps define areas of fibrosis in the LA.
~High-resolution brain MRI with no contrast will include the following sequences for most accurate assessment of embolic lesions: 3D T1 MPRAGE, 3D FLAIR, DWI, ADC, and SWI"
15760926|NCT04769297|Drug|Sublingual Micro-Dose Ketamine|daily micro-dosing of frontline healthcare workers suffering from acute stress disorder due to the COVID-19 pandemic
15760927|NCT04769284|Other|Mental health student|"An ad-hoc questionnaire was designed that included sociodemographic variables related to the characteristics of the students. The variables sex, age, degree, employment situation, coexistence situation, economic situation, origin environment, country of origin, time of residence in the Spanish State were collected.
~Personal variables:
~Gender stereotypes: Short version of the Bem Sex Rol Inventory (BRSI).
~International Physical Activity Questionnaire (IPAQ)
~Abbreviated Goldberg Anxiety Scale EADG
~Modified version of EPP-10 related to COVID-19 (EPP-10-C)"
15760928|NCT04769271|Procedure|Scaling and Root Planing|Supra- and sub-gingival calculus and debris were removed
15760929|NCT04769271|Drug|Scaling and Root Planing with tea tree oil|Supra- and sub-gingival calculus and debris were removed and 5% tea tree oil was applied
15760930|NCT04769258|Biological|Pfizer Comirnaty vaccine|COVID 19 vaccines administered to the patients according to the times and modalities established by the Italian National Vaccination Plan. Further vaccines will be evaluated if and when they are available in Italy during the study period.
15760931|NCT04769232|Device|EG-760Z endoscope by Fujifilm|"Within a single endoscopic procedure under propofol sedation, images of the esophageal wall will be acquired and biopsies will be taken. All patients will be examined using the EG-760Z endoscope by Fujifilm.
~In all patients as part of the clinical routine 4 biopsies of the proximal and 4 biopsies of the distal esophagus will be taken."
15760932|NCT04769219|Other|secondary protection training|Secondary prevention training will be given after acute myocardial infarction
15760933|NCT04769206|Drug|Galantamine|4mg daily titrating up to 8mg twice a day
15760934|NCT04769206|Drug|Placebo|1 pill a day for 4 weeks, 2 pills a day for 8 weeks
15760935|NCT04769193|Other|Adipeau face cream|Adipeau face cream contains the natural actives Carthamus Tinctorius (Safflower) Seed Oil and Kaempferia Parviflora Rhizome Extract (Black Ginger).
15760936|NCT04769180|Other|Evaluation of extraintestinal manifestations|The researchers evaluated the prevalence and kind of extraintestinal symptoms in NCWS patients and the possible relationship between the clinical, serological, genetic and histological characteristics of the NCWS patients and the number and kind of extraintestinal manifestations, using, as control groups, CD and IBS patients.
15760937|NCT04769167|Other|Stool and Blood Specimen Collection|Stool and Blood specimens will be collected at 3 designated time points
15760938|NCT04769167|Other|Follow-up Medical Record Review|Participant medical records as well as the medical records of infants during study enrollment will be reviewed up to 3 years from the date of enrollment.
15760939|NCT04769141|Combination Product|CURATE.AI|"CURATE.AI is one example of an artificial intelligence guided dosing decision tool. It is customized to each individual and can be applicable across many different conditions, as it is disease agnostic.
~This platform has already demonstrated initial success in cancer and transplant populations but yet to be applied to chronic disease patients."
15761274|NCT04766463|Drug|Placebo|Saline Solution
15761275|NCT04766463|Drug|Morphine|Morphine
15760940|NCT04769128|Other|Traditional physical therapy programe|thoracic manipulation spine at the level of T3 and T4 facet joints (Maitland (screw) technique grade V). Using hypothenar eminence of hands, applying direct downward pressure and additional force-directed caudal with one hand and cephalic with the other hand on the transverse processes.
15760941|NCT04769115|Device|Alert for temperature delta|If alert for potential complications refer to appropriate specialist
15760942|NCT04769102|Device|seat cushions|flat versus contoured customized seat cushions
15760943|NCT04769089|Procedure|Treatment with Pulse Dye Laser|Pulse Dye laser treatment will be applied to one randomized area with the 10mm hand piece, duration of 0.45ms, and fluence of 5.25J/s.
15760944|NCT04769089|Procedure|Treatment with CO2 Laser|CO2 laser treatment will be applied to one randomized area with the deep Fx hand piece, 300Hz, 15mJ, 15% density.
15760945|NCT04769089|Procedure|Treatment with combination of pulse dye laser and CO2 laser.|Pulse Dye laser and CO2 treatment will be applied to one randomized area. Pulse Dye will be applied with the 10mm hand piece, duration of 0.45ms, and fluence of 5.25J/s followed by the CO2 laser treatment with the deep Fx hand piece, 300Hz, 15mJ, 15% density.
15760946|NCT04769089|Other|Control|One area will be randomized to receive no laser treatment.
15760947|NCT04769076|Combination Product|Paclitaxel（Albumin-bound）|Three courses of albumin-bound paclitaxel combined with cisplatin and PD-1 monoclonal antibody neoadjuvant treatment followed by cisplatin combined with IMRT (intensity modulated conformal radiotherapy) concurrent radiotherapy and chemotherapy
15760948|NCT04769063|Other|Kinesio Tape|Gluteus medius facilitation and knee spiral taping techniques will be applied to treat dynamic knee valgus
15760949|NCT04769050|Drug|Docetaxel combined with Trastuzumab±Pertuzumab|Docetaxel, 75 mg/m2 ivgtt d1 q3w Trastuzumab, 6 mg/kg(8 mg/kg for initial dose) ivgtt d1 q3w Pertuzumab, 420mg(840mg for initial dose) ivgtt d1 q3w
15760950|NCT04769050|Drug|T-DM1 or Capecitabine combined with Pyrotinib regimen.|T-DM1, 3.6mg/kg(8 mg/kg for initial dose) ivgtt d1 q3w Capecitabine, 1250 mg/m2 bid po d1-14 q3w Pyrotinib, 400mg po daily (continuously)
15760951|NCT04769037|Dietary Supplement|B. infantis|Activated B. infantis EVC001; Bifidobacterium longum subsp. infantis; 8 x 109 colony forming units (CFU) per day
15760952|NCT04769037|Dietary Supplement|Placebo|Lactose identical in appearance and taste to the active supplement
15760953|NCT04769024|Behavioral|LUMEEN|"Participants will benefit from multimodal immersion sessions in relaxing scenarios. These scenarios are based on the technology developed by LUMEEN and consist of three phases. The introduction (10-20 minutes) allows you to introduce, present and discuss in a group around the chosen theme using the software support of the digital tablet. The immersion (6 to 12 minutes) simultaneously immerses the 4 participants in a real environment captured in 360 ° video accompanied by natural sounds and / or music. The conclusion (10-20 minutes) allows you to discuss the experience of the immersion, to elaborate on the feelings and to recall the information shared during the introduction or the immersion.
~The sessions will last about 45 minutes and will be offered twice a week for 8 weeks by a facilitator or a caregiver trained in group care. The sessions will be in groups of 4 participants."
15760954|NCT04769024|Behavioral|USUAL activities|Participants will benefit from thematic group workshops: these workshops follow the themes at each session in the immersive LUMEEN workshops but the proposed activity will be done through the usual paper and pencil type activity. The sessions will last 45 minutes and will be offered twice a week for 8 weeks by a facilitator or a caregiver trained in group care. The sessions will be in groups of 4 participants.
15760955|NCT04769011|Diagnostic Test|Clinical evaluation|Clinical evaluation of participants by means of Autism Diagnostic Observation Schedule, Social Responsiveness Scale, Children Behavior Check List, Conners' Scale
15760956|NCT04769011|Diagnostic Test|Neuropsychological evaluation|The participants' motor skills are measured using the Movement Assessment Battery for Children 2 (MABC2) (Henderson et al., 2007), the Developmental Coordination Disorder Questionnaire (DCDQ) (Wilson et al., 2007), and the kinematic analysis of a reach-to-drop task (Forti et al., 2011; Crippa et al., 2015).Sensorimotor domain will be also further investigated with NEPSY-II (Korkman et al., 2007) (Fingertip Tapping, Imitating Hand Positions, Manual Motor Sequences, and Visuomotor Precision).
15760957|NCT04769011|Diagnostic Test|Neurophysiological evaluation|Magnetic Resonance Imaging (structural MRI and DTI)
15760958|NCT04769011|Diagnostic Test|Genetic evaluation|Either blood or saliva will be obtained for participants for DNA collection. DNA will be extracted in the Molecular Biology Laboratory at the Scientific Institute IRCCS Medea. Captured exome libraries will be sequenced using the Illumina NextSeq 500 in 100 bp paired end reads. Postsequencing reads will be aligned using BWA Enrichment application on BaseSpace. VCF file will be then marked using wANNOVAR (Wang Genomics Lab). The analysis will be focused on non-synonymous variants enrichment in Gene Ontology and Human Phenotype.
15760959|NCT04768998|Other|Observational of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings|Observatory Cohorts focusing (I) on subjects after SARS-CoV-2 infection that are recruited from the general population (POP), and on subjects with acute SARS-CoV-2 infections recruited (II) in university hospital high-care settings or (III) general health care.
15760960|NCT04768985|Drug|Treatment A: Acalabrutinib tablet|Participants will receive fixed single doses of acalabrutinib tablet in 2 treatment periods, under fasted conditions.
15760961|NCT04768985|Drug|Treatment B: Acalabrutinib capsule|Participants will receive fixed single doses of acalabrutinib capsule in 2 treatment periods, under fasted conditions.
15760964|NCT04768959|Behavioral|FelizMente|The intervention aims to improve well-being, without denying the existence of symptoms or problems, focusing on generating positive emotions and actions congruent with the person's values through 11 weekly 90-minute group sessions. The multi-component intervention manual was composed of evidence-based exercises of Positive Psychoterapy Interventions, Acceptance and Commitment Therapy and Mindfulness and was theory driven according the broaden-and-build-theory (Fredrickson, 2001) and the self-serving model of paranoia (Murphy et al., 2018). It was also informed by previous pilot studies carried out on people with paranoid tendencies (see Valiente et al., 2020) and with Severe Psyquiatric Condition samples.
15760965|NCT04768933|Dietary Supplement|Toddler Milk|At least three 130 mL servings daily of study formula are recommended for a total daily intake of 390 mL. Study participants will continue this feeding regimen Days 4 to 28 (approximately 4 weeks).
15760966|NCT04768920|Behavioral|MI-CBT Teletx|"Participants will first receive a 20-45 min phone or video session focused on raising participants' motivation to engage in treatment activities and psychoeducation material about substance use (i.e. engagement session) including possible discussion about risks of substance use, value of alternative healthier activities, and the community and crisis resources pamphlet. The evidence-based manualized psychosocial programs that will be delivered via telehealth are adaptations of cognitive behavioral therapy, motivational interviewing, and other psychosocial interventions to enhance initial and ongoing treatment engagement. TeleTx consists of up to 8 ~30-50 minute psychosocial sessions delivered via phone or videoconference platform (e.g. Zoom etc)"
15760967|NCT04768907|Drug|MaaT013|
15760968|NCT04768894|Procedure|Second transurehral resection of bladder tumour|Remove of the bladder tumour as endoscopically
15760971|NCT04768868|Drug|IMP7068|To evaluate the safety tolerability, pharmacokinetics, and anti-tumor activity of the WEE1 inhibitor IMP7068 monotherapy in patients with advanced solid tumors
15760972|NCT04768855|Drug|LY3540378|Administered IV or SC.
15760973|NCT04768855|Drug|Placebo|Administered IV or SC.
15760974|NCT04768842|Drug|LY3209590|Administered SC.
15760977|NCT04768816|Drug|0.9% Sodium Chloride|0.9% Sodium Chloride in control group
15760978|NCT04768816|Biological|Autologous Umbilical Cord Blood|Autologous Umbilical Cord Blood Mononuclear Cells Therapy in Autism Spectrum Disorder for safety and effect evaluation.
15760979|NCT04768803|Biological|acylated and unacylated ghrelin dosages|realization of plasma samples to evaluate of levels of ghrelin and collection of plasma and cells
15760980|NCT04768790|Other|multidisciplinary program|multimodal exercises to improve, through gradual exposure, cervical mobility, postural control and strengthening of the cervical muscles; stabilization techniques for the deep neck muscles; task-oriented exercises maintaining the activation of the deep spinal muscle. Under the supervision of a psychologist, the subjects will also be involved in cognitive-behavioral therapy aimed at modifying the fear of movement (kinesiophobia) and the maladaptive behavior of the disease. Ergonomic consultancy.
15760981|NCT04768790|Other|General program|exercises for muscle strengthening, regional stretching and spinal mobilization. Ergonomic consultancy.
15760982|NCT04768777|Behavioral|Behavioural intervention for physical activity for multiple sclerosis (BIPAMS)|The current behavioral intervention consists of two primary components; an internet website and one-on-one video chats with a behavioral coach. The internet website involves content delivered through interactive video courses.The interactive video courses are based on elements of social cognitive theory. Each course consists of an introduction, the primary content, and a take home message.The interactive courses include embedded, supplementary options such as videos on content and worksheets related to the topic.A pedometer is provided for tracking steps, and these steps will be entered into the website so progress can be monitored. The chats support adherence to the intervention,discussion of website material,supportive accountability,and reporting of adverse events/injuries. The chats are conducted face-to-face through an online videoconferencing platform. There are a total of 12 chats over 16 weeks. Chats occur on weeks 1-8, 10-11, 13 and16.
15760983|NCT04768764|Procedure|Ultrasound Guided Middle Adductor Canal Block|"Middle adductor canal block will be applied post-operatively with guidance of USG.
~Drug:Bupivacaine 0.25% Injectable Solution"
15760984|NCT04768764|Procedure|Ultrasound Guided Femoral Nerve Block.|Femoral nerve block will be applied post-operatively with guidance of USG. Drug:Bupivacaine 0.25% Injectable Solution
15760985|NCT04768764|Drug|Bupivacain|10 ml %0,5 Bupivacaine will be diluted with 10 ml saline solution. Bupivacaine 0.25% Injectable Solution
15760986|NCT04768764|Procedure|Spinal Anesthesia|Patients will be placed in the lateral decubitus position.Subarachnoid space will be entered through the most suitable intervertebral space.Bupivacaine 0.5% Heavy will be given in the appropriate dose.
15760987|NCT04768751|Diagnostic Test|kidney assessment|Urea, BUN, and Creatinine BLOOD LEVELS
15760988|NCT04768738|Device|Auricular Vagus Nerve Stimulation Level Of Above Threshold|Biphasic current was applied as follows; frequency 10 Hz, in Modulation mode (Modulation mode is a combination of pulse rate and pulse width modulation. The pulse rate and width are automatically varied in a cycle pattern. The pulse width is reduced by 50% from its original setting in 0.5 second, then the pulse rate is reduced by 50% from its original setting in 0.5 second. Total cycle time is 1 second.), the pulse width was 300 μs. The current intensity was kept constant where the participant felt the current comfortably and applied for 5 minutes.
15760989|NCT04768738|Device|Auricular Vagus Nerve Stimulation Level Of Subthreshold|biphasic current was applied as follows; frequency 10 Hz, in Modulation mode (Modulation mode is a combination of pulse rate and pulse width modulation. The pulse rate and width are automatically varied in a cycle pattern. The pulse width is reduced by 50% from its original setting in 0.5 second, then the pulse rate is reduced by 50% from its original setting in 0.5 second. Total cycle time is 1 second.), the pulse width was 300 μs. The parameters were the same with Above Threshold Group but the current was reduced to where the participant did not feel the current after the threshold value was reached and again applied for 5 minutes.
15760990|NCT04768738|Device|Auricular Vagus Nerve Stimulation Sham Method|Participants were shown that the device was working, but no current was given.
15760991|NCT04768738|Diagnostic Test|5 Minutes Bicycle Exercise|Participants in this group were asked to perform bicycle exercise with maximum performance under 50 watts for 5 minutes.
15760992|NCT04768725|Behavioral|Dietary intervention combined with physical-cognitive exergaming|Intermittent Fasting (IF) [self-selected diet with 25-75% of estimated baseline energy requirements for 2 days/week (fast day) along with ad libitum for 5 days/week (feed day)] combined with physical-cognitive exercise [60-70% of heart rate maximum for aerobic and 60-70% of 1 repetition maximum, 8-12 repetitions/set, 3 sets of each exercise for resistance exercise; memory, attention, and executive function for cognition], 60 minutes per session, 3 sessions per week for 12 weeks (36 sessions)].
15760993|NCT04768725|Behavioral|Dietary intervention|Intermittent Fasting (IF) [self-selected diet with 25-75% of estimated baseline energy requirements for 2 days/week (fast day) along with ad libitum for 5 days/week (feed day)].
15760994|NCT04768725|Behavioral|Physical-cognitive intervention|Physical-cognitive exercise [60-70% of heart rate maximum for aerobic and 60-70% of 1 repetition maximum, 8-12 repetitions/set, 3 sets of each exercise for resistance exercise; memory, attention, and executive function for cognition], 60 minutes per session, 3 sessions per week for 12 weeks (36 sessions)].
15760995|NCT04768712|Behavioral|Weight bearing aerobic exercise|Weight bearing aerobic exercise three times per week.
15760996|NCT04768699|Drug|TQG203|TQG203,30µg/kg body weight, will be administered as intravenous (i.v.) administration over a period about 2minutes (min) on Study Day 1 once.
15760997|NCT04768699|Drug|TQG203/NovoSeven®|In each of the two study periods (separated by a washout about two days),a single dose of TQG203 or NovoSeven® will be administered.TQG203 or NovoSeven®,90µg/kg body weight, will be administered as intravenous (i.v.) administration over a period about 2minutes (min) on Study Day 1.
15760998|NCT04768699|Drug|TQG203|TQG203,180µg/kg body weight, will be administered as intravenous (i.v.) administration over a period about 2minutes (min) on Study Day 1 once.
15760999|NCT04768686|Drug|FLX475|tablet
15761000|NCT04768686|Drug|Pembrolizumab|IV infusion
15761001|NCT04768673|Drug|CKD-393 formulation I|single, oral administration of 2 tablets under fed condition
15761002|NCT04768673|Drug|CKD-393 formulation II|single, oral administration of 2 tablets under fed condition
15761003|NCT04768673|Drug|D501, D759, H053|single, oral administration of 1 D501, 1 D759 and 2 H053 under fed condition
15761004|NCT04768660|Other|gum|Other: Chewing gum ChiczaTM organic chewing gum 6 pieces a day Other: Glucose 12ml glucose solution (13,6g) per day
15761005|NCT04768647|Device|TNM|TNM is a small portable head set that can be used by the participants at home to stimulate the vestibular system
15761006|NCT04768634|Diagnostic Test|Provocative electrophysiology study|Provocative electrophysiology testing will be performed at the bedside using the temporary pacing wires placed at the time of surgery.
15761007|NCT04768621|Other|Questionary|Questions about patient health after wintering in Southern and Antarctic French Lands about social and demographics items, psychologic and psychiatric items, sleep disorders, immunological disorders,and endocrinologic disorders, sociological consequences of wintering
15761008|NCT04768608|Drug|PD1-PSMA-CART cells|PD1-PSMA-CART cells will be given IV at split doses
15761009|NCT04768595|Dietary Supplement|Placebo|Two, 1g capsules taken daily with food
15761010|NCT04768595|Dietary Supplement|Ceto 10|Two, 1g capsules daily with food
15761011|NCT04768595|Dietary Supplement|Fish oil|Two, 1g capsules daily with food
15761012|NCT04768582|Diagnostic Test|P2Y12-reaction-units (PRU) by VerifyNow-P2Y12 assay|The efficacy endpoint was platelet reactivity, of which was serially assessed using the VerifyNow-P2Y12 assay and the results were expressed as P2Y12-reaction-units (PRU).
15761013|NCT04768569|Drug|Zonisamide 100Mg Cap|ZONEGRAN® is commercially available for oral administration as capsules containing 100 mg of Zonisamide.
15761014|NCT04768569|Drug|Placebo|The placebo will contain microcrystalline cellulose which is the predominant filler in the generic capsule.
15761015|NCT04768556|Other|EEG experimental sessions 1|An EEG experimentation session on the stop-signal task of inhibiting a prepared discrete graphic action.
15761016|NCT04768556|Other|EEG experimental sessions 2|An EEG experimentation session on the stop-signal task of inhibiting an ongoing rhythmic action
15761017|NCT04768543|Device|Upper airway stimulation (Inspire Medical Systems, Inc.)|phasic hypoglossal nerve stimulation device
15761018|NCT04768530|Procedure|Scaling and Root Planing|Supra- and sub-gingival calculus and debris were removed
15761019|NCT04768530|Drug|Nitazoxanide hydrogel|Scaling and root planing was performed in combination with the subgingivally delivered thermosensitive Nitazoxanide hydrogel as adjunct antimicrobial therapy.
15761020|NCT04768504|Drug|Tofacitinib 10 mg|Tofacitinib 10 mg PO BID for 30 days
15761021|NCT04768491|Drug|Dacomitinib|effectiveness and safety profile in patients with EGFR mutation-positive advanced NSCLC treated with dacomitinib (Vizimpro®) as the first-line treatment followed by 3rd generation EGFR-TKI in case the T790M resistance mutation was developed.
15761022|NCT04768478|Drug|CBD|25mg CBD ODTs (orally disintegrating tablet), with instructions to take CBD tablets t.i.d. (total of 50mg per dose t.i.d.) to be administered with routine post-operative pain management
15761023|NCT04768478|Drug|Placebo|Visually indistinguishable placebo ODTs, with instructions to take two tablets t.i.d., to be administered with routine post-operative pain management
15761024|NCT04768465|Drug|Pyridostigmine, Prednisone, Tacrolimus|Dose of tacrolimus should be initiated based on CYP3A5*3 polymorphism and adjusted to achieve blood trough concentration of 4.8-10.0 ng/ml. Prednisone is administrated with an initial dose of 0.25mg/kg/d and started to tamper with the achievement of MMS or the presence of any intolerable side effects. The rate of tampering is considered by the physician, usually no more than 5mg/month. If the participants failed to maintain MMS, dose of prednisone should be increased 5mg/week to 0.25mg/kg/d and maintained until MMS reached again. After MMS sustained for 1 month, prednisone dose would be tapered again with 2.5mg/month. Calcium and potassium supplements and gastric mucosa protectors could be addressed to avoid any adverse effects of prednisone. Treatment regimens are determined based on the physician's judgment and preferences of the patients. This study was observational and do not change the clinical course of patients.
15761025|NCT04768465|Drug|Pyridostigmine, Tacrolimus|Dose of tacrolimus should be initiated based on CYP3A5*3 polymorphism and adjusted to achieve blood trough concentration of 4.8-10.0 ng/ml. Treatment regimens are determined based on the physician's judgment and preferences of the patients. This study was observational and do not change the clinical course of patients.
15761026|NCT04768439|Drug|Low Dose Vitamin D|Patients will receive a 200 IU/d vitamin D since they tolerate full enteral nutrition.
15761027|NCT04768439|Drug|High Dose Vitamin D|Patients will receive 1600 IU/d vitamin D since they tolerate full enteral nutrition.
15761028|NCT04768426|Drug|Capecitabine|1000 mg/m2 administered on Days 1 to 14 of 21-day treatment cycles, for 8 cycles.
15761029|NCT04768413|Other|Teleconsultation either by phone or by computer consultation. Quantitative and qualitative approaches to analysis|A group of patients who have voluntarily adhered to the clinic's tele-assisted consultation and who receive remote, multidisciplinary team care without requiring physical displacement.
15761078|NCT04767997|Dietary Supplement|Probiotic formulation|Participants will be asked to take one capsule daily, containing 3 billion CFU of the probiotics.
15761030|NCT04768413|Other|Care modalities. Quantitative and qualitative approaches to analysis|Group of patients who wish to continue with the usual face-to-face consultation, since for these patient's isolation measures allow trips to the care centers and who receive care from a multidisciplinary team on a regular basis.
15761031|NCT04768400|Drug|Arm I (MEP)|Arm I (MEP): Motor evoked potential will be measured in various degree of the neuromuscular blockade.
15761032|NCT04768387|Dietary Supplement|Personalized microbiome diet|The personalized nutrition model estimates the optimal micronutrient compositions for a required microbiome modulation. In this study, we computed the microbiome modulation needed for an IBS case, based on the IBS-indices generated by the machine learning models. According to that, the baseline microbiome compositions are perturbed randomly with a small probability p. Perturbed profiles are accepted with a probability proportional to the decrease in the IBS-index as suggested by Metropolis sampling. This Monte-Carlo random walk in the microbiome composition space is expected to meet a low IBS-index microbiome composition nearby the baseline microbiome composition of the patient with a minimal modulation. The personalized nutrition model, then, estimates the optimized nutritional composition needed for this individual, expecting to drive the IBS-index to lower values.
15761033|NCT04768374|Other|Virtual Reality with Kinect|"In the study it was conducted a 12 week-intensive VR intervention (twice a week, 45 minutes each) and compared the results in the 12th week to investigate the effects of rehabilitation and follow-up assessments were made in the 16th and 24th weeks. From the beginning of the VR intervention, each game was played in equal durations by each participant. However, the difficulty of the games varied depending on the child's performance.
~Microsoft Kinect Games-Carnival Games was used as VR intervention. In meeting held with the authors to determine which games would be used in the VR program, 5 games were chosen and the remaining games were removed from the program because of their similar contents."
15761034|NCT04768374|Other|Conventional Occupational Therapy (COT)|"The COT based on neurodevelopmental treatment was carried out by the same occupational therapist. The treatment goals aimed at increasing the use of participant's extremities and improving the independence in ADL. The activities in the treatment were chosen in view of children's motor skills and daily living activities such as getting dressed, solving puzzles, and writing etc.
~Both groups received COT while the control group received COT only for 12 weeks."
15761035|NCT04768361|Behavioral|Behavioral Activation without Mindfulness|"Behavioral Activation without Mindfulness includes functional analysis as key to defining out-of-session and activation strategies as central to mood change."
15761036|NCT04768361|Behavioral|Behavioral Activation with Mindfulness|"Behavioral Activation with Mindfulness includes functional analysis as key to defining out-of-session and activation strategies and mindfulness as central to mood change."
15761037|NCT04768335|Behavioral|cognitive experiments' session|The aim of this unique session of cognitive experiments is to study the links between source memory deficits and externalization abilities in healthy control subjects. Results of this Arm 2 will be compared to those of Arm 1.
15761038|NCT04768322|Device|HeartMate 3 TM Left Ventricular Assist System|The HeartMate 3 TM Left Ventricular Assist System will be implanted within 21 days of randomization.
15761039|NCT04768322|Other|Guideline Directed Medical Therapy|Patients randomized in the control group will continue their guideline directed medical therapy which comprises the following stable combination at the maximal tolerated dose of betablockers, Angiotensin-Converting-Enzyme-inhibitors or Angiotensin II Receptor Blockers or Angiotensin receptor Neprilysin inhibitor and Mineralocorticoid Receptor Antagonists if tolerated.
15761040|NCT04768309|Other|Ex vivo exploration of the effect of a probiotic over precursor indole production|Fresh feces in chronic kidney patients and healthy volunteers will be collected. The feces will be instilled in artificial intestine with and without selected probiotics and production of uremic toxins will be measured.
15761044|NCT04768283|Other|Additional balance and resistance training - 1|"Additional exercise program with balance and resistance training three times per week.
~The balance training included exercises to improve static as well as dynamic balance ability, for 15-20 minutes.
~The resistance training included exercises with weights (0,5, 1 or 2 kg), elastic resistance rubbers, intensity 30-50% 1-RM, 10 repetitions with 3 sets and 3 minute rest between sets."
15761045|NCT04768283|Other|Additional balance and resistance training - 2|"Additional exercise program with balance and resistance training three times per week.
~The balance training included exercises with static and dynamic balance training device Biodex Balance System TM SD, for 15-20 minutes. Exercises are performed with the following programs: Postural stability training, Limits of stability training, Weight shift training, Maze control training, Random control training, Percent weight-bearing training.
~The resistance training included exercises with HUR strength training machines, intensity 30-50% 1-RM, 10 repetitions with 3 sets and 3 minute rest between sets. Strength training was performed with the following exercises: Leg press, leg extension, leg abduction, leg adduction."
15761046|NCT04768270|Other|no intervention|It is an observation trial.
15761047|NCT04768257|Behavioral|Physical activity|We will assess physical activity patterns of patients at baseline (at discharge from hospital or at patients' home), at 12 weeks and 6 months, through an objective measurement (triaxial accelerometer).
15761048|NCT04768244|Other|maternal SARS-CoV-2 infection|positive PCR in nasopharinx and/or presence of antibodies in serum
15761049|NCT04768231|Drug|Rifampin|The target dose of 35mg/kg will be reached supplementing fixed-dose combination tablets (standard dose) with rifampin-only tablets.
15761050|NCT04768205|Device|Kinesio tape|The Kinesio tex tape is a medical tape that had been certified and patented.
15761051|NCT04768192|Procedure|Physical Rehabilitation without lokomat|"Conventional physiotherapy is performed in 10 weekly sessions (45 minutes each) over 4 weeks(total 40 sessions).
~Specific exercises are administered to improve gait, balance and functional abilities focusing on:
~strengthening the gluteus and quadriceps muscles stretching the hip flexor and hamstrings muscles increasing static balance increasing dynamic balance increasing functional abilities improving ground gait going up and down the stairs.
~Physiotherapists can choose from a list of 25 standard exercises, according to some constraints:
~strengthening exercises had to involve all the lower limb joints (no segmental intervention)
~during each session, at least 4 out of the 7 categories above had to be delivered
~the impossibility to perform any of the categories above during any session had to be recorded in the patient's treatment diary.
~Physiotherapists of the treatments group discuss patients' diaries during weekly meetings."
15761052|NCT04768192|Procedure|Physical Rehabilitation with Lokomat|"The rehabilitation protocol consists of 20 sessions of robotic training alternated with 20 sessions of conventional physiotherapy (CP). Each treatment is performed in 5 weekly sessions (45 minutes each) over 4 weeks.
~Robotic training aimed to recovery/improve walking capacity from the initial Gross Motor Function Classification System (GMFCS) level. It is performed using the Lokomat® (Hocoma AG, Volketswil, Switzerland) gait orthosis. Initial set ups includes 50% body weight unload, gait velocity adjusted on the patient individual capability (1.5 km/h on average) and 100% guidance force. Both weight unload and guidance force are gradually reduced across sessions according to patient recovery of muscle strength and allowing patients to work harden and move more freely.
~Children engagement, active participation and motivation were reinforced through frequent encouragement by therapists and performance feedback implemented in the exercise video-games."
15761053|NCT04768179|Drug|3-dayIVM 200 mcg/kg/day/14-day 75mgASA/day + standard of care (intervention 1)|Low dose aspirin for 14 days plus ivermectin at 200 mcg/kg/day or 600 mcg/kg/day for 3 days
15761054|NCT04768166|Drug|Miglustat|Evaluate safety and tolerability of Miglustat in a group of subjects affected of SPG11.
15761055|NCT04768153|Biological|Serology|Serological diagnosis of COVID-19 in patients with cancer from a sample of cancer patients, at 3 and 6 months after implementation of confinement in France
15761056|NCT04768140|Procedure|Bobath treatment approach|scapulothoracic mobilization exercise, reaching in different directions in the supine position and upper extremity weight transfer exercise.
15761057|NCT04768140|Procedure|Conventional physiotherapy|range of motion, stretching, strengthening exercises, electrotherapy, thermotherapy, balance and mobility exercises and exercises for daily living activities.
15761058|NCT04768127|Other|early aftercare|This group begins the aftercare program immediately after their bariatric surgery.
15761059|NCT04768127|Other|mid-term to late aftercare|This group begins the aftercare program 18 months post surgery.
15761060|NCT04768114|Behavioral|Genetically-Informed RiskProfile|"Participants will meet with a behavioral interventionist to receive their personalized genetically-informed RiskProfile intervention which incorporates smoking-related genetic risk propensity and phenotypic risk (cigarettes smoked per day) into a risk communication tool designed to activate behavior change, specifically, to increase the use of smoking cessation medications and promote smoking-related behavior change.
~This is a fully remote trial, with intervention delivered via video conferencing."
15761061|NCT04768114|Other|Brief Cessation Advice|"Participants will meet with a behavioral interventionist to receive standardized brief advice to quit smoking and encouragement to use freely-available smoking cessation resources. Participants will receive their personalized RiskProfile after all data collection has been completed.
~This is a fully remote trial, with brief cessation advice delivered via video conferencing."
15761063|NCT04768088|Other|Falling Training|For the falling training, participants will be instructed to initially land softly with increased knee and hip flexion and then smoothly fall to the direction of the movement while transferring the weight from the feet to the hands and subsequently to the lateral trunk and hip. The training program includes three one-hour training sessions over a week with one or two days between two sessions. Each training session will begin with a warm-up protocol. Participants will progressively increase the task difficulty and decrease the thickness of the mat. For each training session, participants will perform a minimum of one successful practice trial for each task difficulty and each landing direction on the thicker mat and then complete a minimum of three successful practice trials for each task difficulty and landing direction on the thinner mat. The last training session involves falling on a 0.5-inch mat, which is the same as the surface for the post-training and retention assessments.
15761064|NCT04768075|Drug|Camrelizumab|Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody
15761065|NCT04768075|Drug|Placebo|IV infusion Simulator of Camrelizumab
15761066|NCT04768075|Drug|Cisplatin|IV infusion
15761067|NCT04768075|Drug|Carboplatin|IV infusion
15761068|NCT04768075|Drug|Pemetrexed|IV infusion
15761069|NCT04768075|Drug|Paclitaxel|IV infusion
15761070|NCT04768075|Drug|Albumin paclitaxel|IV infusion
15761071|NCT04768062|Drug|Viltolarsen|Received during weekly intravenous infusions
15761072|NCT04768049|Other|Tool Translation|Data Collection procedure will be done in two phases. The first phase will revolve around the translation of the instrument. Firstly the tool will be translated into Urdu with help of two professional translators and then it will be back translated into English to cross check the clarity of text. The translation will focus more on the context and understanding of the text rather literal word-to-word meanings. The translation will be done according to the WHO guidelines
15761073|NCT04768036|Other|IMPROVE DD VTE Tool|"Universal SMART on FHIR platform-based EHR-embedded IMPROVE VTE CPR with electronic order entry incorporated into required admission and discharge EHR workflow."
15761074|NCT04768023|Drug|Juvit D3|Dosage based on the BMI as followed: for BMI under 25 - 4000 IU/day, for BMI between 25 and 30 - 5000 IU/day, and for BMI over 30 - 6000 IU/day.
15761075|NCT04768023|Behavioral|steps per day|The participants will be prompt to do 3500-8000 steps per day.
15761076|NCT04768023|Drug|Placebo|Matching amount of vegetable oil to the vitamin D3.
15761077|NCT04768010|Drug|Misoprostol|Participants will started by receiving 100 micrograms of oral misoprostol twice daily. If adverse effects are not noted dose can be titrated up to 200 micrograms of misoprostol twice daily. Participants will receive a total of five doses.
15761079|NCT04767997|Dietary Supplement|Placebo|Participants will be asked to take a placebo capsule daily.
15761085|NCT04767958|Diagnostic Test|Spartan COVID-19 Platform|Nasal-pharyngeal swab for testing on the Spartan Covid-19 platform
15761086|NCT04767932|Behavioral|vibration machine|Experimental: vibration intervention the experimental group will perform 20mins/ section, three times weekly for 8 weeks vibration training
15761087|NCT04767919|Procedure|Standard Percutaneous Nephrolithotomy (sPCNL)|Endoscopic stone procedure using a laser placed in the kidney through an 30 Fr access sheath following balloon dilation.
15761088|NCT04767919|Procedure|Minimally Invasive Percutaneous Nephrolithotomy (MIP)|Endoscopic stone procedure using a laser placed in the kidney through an 18 Fr access sheath following either balloon dilation or dilation using a single step metal dilator.
15761089|NCT04767906|Drug|Cabozantinib|The medication is taken once a day for 336 days (max.). The start dose is 60mg and can be reduced according to the physicians decision. 40mg and 20mg are also available.
15761090|NCT04767880|Dietary Supplement|Whey|Doses of 10, 15, 20 and 30 gram protein of a regular whey protein compound (whey protein isolate WPI (Lacprodan® ISO.Water. from Arla Foods Ingredients))
15761091|NCT04767880|Dietary Supplement|Placebo|The placebo contains <1 kcal and 0 g protein
15761092|NCT04767867|Other|Pre-oxygenation|"Induction of anaesthesia after 2mins 45 seconds of pre-oxygenation with 1-1.5mcg/kg remifentanil plus 2-3mg/kg propofol. Propofol (10mg/kg/hr) and remifentanil (0.15mcg/kg/min) infusions commenced until study conclusion.
~Positive pressure ventilation commenced at Sp02 92%. Failure to intubate the patient during the first minute of apnoea results in withdrawal from the study.
~Blood samples obtained from an arterial catheter immediately prior to commencing pre-oxygenation, after 90 and 180 seconds of pre-oxygenation, after one minute of apnoea, and every two minutes during the apnoeic period."
15761096|NCT04767841|Drug|Metformin|Metformin 1000mg tablet plus celecoxib 200 mg capsule
15761097|NCT04767841|Drug|Placebo|Placebo tablet plus celecoxib 200 mg capsule
15761098|NCT04767828|Drug|PYRROTINI|CAPECITABINE: 800 mg/m2 twice daily, taken orally within 30 minutes after meal (one in the morning and one in the evening, 12 hours apart, equal to a daily dose of 1600 mg/m2, with one dose in the morning and one dose in the morning) .
15761099|NCT04767828|Radiation|Brain radiation therapy|Brain radiation therapy: the dose and frequency of brain radiation therapy are determined by the doctor according to the patient's condition.
15761100|NCT04767815|Drug|Diet A group|Fasting + DWN12088 200 mg
15761101|NCT04767815|Drug|Diet B group|30 minutes after a high-fat meal + DWN12088 200 mg
15761102|NCT04767815|Drug|Diet C group|2 hours after a high-fat meal + DWN12088 200 mg
15761103|NCT04767802|Drug|PTG-300|Hepcidin mimetic
15761104|NCT04767789|Dietary Supplement|NZ-GHMH-01|Each randomized subject will consume 1 capsule daily bringing 100 mg (≥ 2 x 109 CFU) of active ingredient during 16 weeks (from V2 to V5 visits).
15761105|NCT04767789|Dietary Supplement|Placebo|Each randomized subject will consume 1 capsule with no active ingredient daily during 16 weeks (from V2 to V5 visits).
15761106|NCT04767776|Drug|Rivaroxaban|rivaroxaban 40 mg/day (1 day).
15761107|NCT04767776|Drug|Activated charcoal|Activated charcoal 2 hours after rivaroxaban administration (1 day).
15761108|NCT04767763|Diagnostic Test|Assessment of TSH, fT3, fT4,TRH, TT3, TT4, rT3 in patients with CVVHDF|blood samples were collected before initiation of CRRT and at 1,2,3,6,9-day following. Last samples were collected 3 days after the end of CRRT.
15761109|NCT04767750|Other|Blood sample collection|"5ml of peripheral blood samples will be collected into tubes containing EDTA from all subjects and the following procedures will be performed:
~Peripheral blood mononuclear cells (PBMCs) will be isolated from blood samples.
~Total RNA extraction from PBMCs by Trizol reagent and spin column.
~Reverse transcription to cDNA.
~The expression levels of lncRNA H19, IGF-1R mRNA and GAPDH gene (control gene) will be determined by Real-Time Quantitative PCR"
15761110|NCT04767737|Other|Topically Administered Lavender Aromatherapy|3 puffs (0.3 ml) of 100% lavender (Lavandula Angustifolia) essential oil to the topical lavender oil group were sprayed on the arms of the patients.
15761111|NCT04767737|Other|Topically Administered Water|3 puffs (0.3 ml) of topical distilled water to the placebo group were sprayed on the arms of the patients.
15761112|NCT04767724|Device|Extracorporeal shock wave|Participants received 3 ESWT sessions once per week for 3 consecutive weeks or a single injection of one mL (40 mg) of betamethasone into the region surrounding the median nerve.
15761113|NCT04767711|Dietary Supplement|Lactobacillus reuteri ATCC PTA 6475 (L. reuteri 6475)|L.reuteri high or low dose with cholecalciferol compared to cholecalciferol only.
15761114|NCT04767711|Drug|Prednisolone|Oral glucocorticoid 25 mg daily for 7 days.
15761115|NCT04767698|Drug|Belimumab|200 mg SC weekly for 36 months
15761116|NCT04767698|Drug|Short-course Ocrelizumab|300 mg, two infusions two weeks apart and then 600 mg as a single infusion after six months (only one time) (total of two courses of treatment)
15761117|NCT04767698|Drug|Continued Ocrelizumab|300 mg, two infusions two weeks apart and then 600 mg as a single infusion every six months for a total of 36 months
15761118|NCT04767672|Dietary Supplement|Non digestible carbohydrates|the subjects will consume 2 bags of 10 grams per day of the product: 1 bag in the morning and 1 bag at lunch or in the evening, at the beginning of the meal, diluted in a large glass of beverage, during 12 weeks.
15761119|NCT04767672|Dietary Supplement|Placebo|the subjects will consume 2 bags of 10 grams per day of the product: 1 bag in the morning and 1 bag at lunch or in the evening, at the beginning of the meal, diluted in a large glass of beverage, during 12 weeks.
15761120|NCT04767659|Device|MAMMOT2|Breast cancer patients candidate for neoadjuvant chemotherapy will be evaluated with optical imaging prior to commencement of NAC/baseline, 2-5 days post-NAC, 6-8 days post-NAC, 2 weeks post-NAC, half-way through and on completion of NAC. 2 additional optical evaluations will be carried out on the first 5 patients enrolled, one before breast biopsy and one after the positioning of the metallic clip, in order to evaluate the potential artefacts related to these procedures.
15824808|NCT04245865|Drug|Oxaliplatin|85 mg/m2 iv
15761121|NCT04767646|Procedure|Intensive rehabilitation program with CPNB|"The patient will have an intensive rehabilitation program (two 30-minute kinesitherapy sessions every day and 30-minute occupational therapy sessions 5 days a week) with the CPNB.
~The patient will have follow-up consultation at 1 month, 3 month, 6 month and 1 year after the beggining of the intensive rehabilitation program"
15761122|NCT04767633|Drug|split dose vs standard dose of sodium pico sulfate plus magnesium sulfate in children for bowel cleansing|The preparations will be dispensed by a nurse who carefully explained how the products should be taken, emphasising the importance of complete intake of the solution to ensure a safe and effective procedure. Moreover, each patient will be provided with dietary instructions: low residue diet for 3 days before colonoscopy. During and after bowel preparation, solid food will not be allowed. Clear liquid could be taken until 2 hours before the procedure. All colonoscopy will be performed between 11:00 and 15:00 by two endoscopists.
15761123|NCT04767620|Drug|Rugdenzengsheng No. 1 prescription|The study group was treated with the No. 1 Mammary Gland Growth Recipe orally, a total of 1 course of treatment, each course of 14 days, avoiding the menstrual period. The specific composition of Mammary Gland Hyperplasia No. 1 Recipe: Angelica 10g, Radix Paeoniae Alba 10g, Atractylodes Macrocephala 10g, Ginger 3g, Peppermint 6g, Vinegar Green Peel 6g, Lychee Seed 12g, Tangerine Seed 10g, Corydalis 10g, Fritillaria 6g, Trichosanthis 10g, Kombu 20g , Mustard seeds 10g, Moutan bark 6g, Poria 10g, North Bupleurum 6g. Method of administration: 14 doses in total, taken twice a day. The medicine is formulated in the herbal medicine room of the Affiliated Hospital of Qinghai University, with strict quality control.
15761124|NCT04767594|Drug|Palbociclib + endocrine therapy|Palbociclib + letrozole, or Palbociclib + anastrozole, or Palbociclib + exemestane, or Palbociclib + fulvestrant after prior endocrine therapy In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone-releasing hormone (LHRH) agonist.
15761125|NCT04767581|Drug|KHK7791|oral administration
15761126|NCT04767581|Drug|Placebo|oral administration
15761127|NCT04767568|Diagnostic Test|Blood sample|"In cohort A: Blood sample n°1 (PBMC, plasma, ctDNA) previous colonoscopy. If no cancer lesions: STOP. If cancer lesion detected : Blood sample n°2 (PBMC, plasma, ctDNA) collected 1 month after surgery.
~In cohort B: Blood sample n°1 (PBMC, plasma, ctDNA) collected before surgery. Blood sample n°2 (PBMC, plasma, ctDNA) collected 1 month after surgery"
15761128|NCT04767568|Other|Tumor tissue|In each cohort, tumor tissue will be collected from the surgical specimen.
15761129|NCT04767555|Procedure|ILM (inner limiting membrane) peeling|The standard technique for the removal of the inner limiting membrane is a dye-assisted ILM peeling established since 20 years as the standard of care to treat vision loss due to epiretinal membranes or macular holes in eyes with an otherwise stable retina, but not during retinal detachment surgery. Other dyes may show a stronger staining effect but since there is evidence of a potential toxicity of ICG the investigators use the well-tolerated and for this purpose approved trypan blue dye Membrane Blue ® (Dorc). This intervention will be performed in addition to standard vitreoretinal re-attachment surgery.
15761130|NCT04767542|Drug|Intravenous Infusion|analgesic
15761131|NCT04767542|Procedure|Local anesthesia|Local anesthetic agent (Bupivacaine 0.5%) will be injected bilaterally to transverses abdominis muscle
15761132|NCT04767529|Drug|EFX|Administered by subcutaneous injection
15761133|NCT04767529|Drug|Placebo|Administered by subcutaneous injection
15761134|NCT04767516|Other|no intervention|no intervention
15761135|NCT04767503|Drug|Propofol|Maintence of anestheisa with propofol guided by the bispectral index in the range 40-60.
15761136|NCT04767503|Drug|Desflurane|Maintence of anestheisa with desflurane guided by the bispectral index in the range 40-60.
15761137|NCT04767490|Procedure|Standard Duodenal Switch|
15761138|NCT04767490|Procedure|Single Anastomosis Duodenal Switch|
15761139|NCT04767477|Other|Face-to-face rehabilitation|Aerobic training will be performed with 60% to 80% of the maximum VO2 obtained through the CPET. The exercise will be performed on the treadmill, with a total time of 40 minutes, with 5 minutes of warm-up, 30 minutes of conditioning, 5 minutes of cooling down. Resistance training will be performed for upper and lower limbs and the load used in the exercises will be 60% of the maximum repetition test (1RM), with load progression every six sessions. The exercises are performed in three series of 12 repetitions.
15761140|NCT04767477|Other|Telerehabilitation|The telerehabilitation protocol will consist of stretching the muscles of the upper and lower limbs and accessory muscles of breathing. The conditioning phase will consist of stationary walking, side running, jumping jump and stationary running, 3 times of 40 seconds with a 30-second passive rest interval between them. Resistance training will be applied to the muscles of the upper limbs and lower limbs, with specific exercises for each musculature, using elastic bands as resistance.
15761141|NCT04767464|Other|Compass Course|The Compass Course is an 8-session group course designed to address purpose in life of those with Breast Cancer. Enrollment in this arm will involve participation in the Compass Course virtually.
15761142|NCT04767451|Diagnostic Test|ultrasound assessment|Lead (Pb), Cadmium (Cd), Gadolinium (Gd), Arsenic (As), Mercury (Hg), Cobalt (Co), Vanadium (V), Titanium (Ti), Sulfur (S), Chromium (Cr), Silver (Ag), Molybdenum (Mo), Boron (B), Lithium (Li), and Nickel (Ni) measurements
15761143|NCT04767438|Other|Pregnant women|All pregnant women that present to the 12-week scan in the Obstetrics Unit
15761144|NCT04767425|Radiation|Brachytherapy|• 3D image-based cervical cancer brachytherapy will be delivered as 4 sessions x 7 Gy High Dose Rate (HDR) brachytherapy
15761145|NCT04767412|Device|aerobic exercise training, inspiratory muscle training|All participants received 30 min of aerobic exercise training thrice per week for a period of 12 weeks, whereas the group B received an additional 30 min of IMT before each aerobic exercise session.
15761146|NCT04767399|Behavioral|protaper next|rotary systems used on patients need root canal treatment
15761149|NCT04767360|Device|Bioness-300|Therapeutic treatment of foot drop with the electrical stimulation device Bioness L300.
15761150|NCT04767347|Other|23.0°C WBGT - Fixed Work Rate|"For four hours, participants will walk on a treadmill to elicit 430 W of metabolic heat production in the following conditions:
~23.0°C WBGT (29°C, 46% relative humidity) @ 60 min exercise per hour"
15761303|NCT04766216|Other|Usual care provided by anticoagulation providers|Normal care provided by anticoagulation providers
15761151|NCT04767347|Other|25.5°C WBGT - Fixed Work Rate|"For four hours, participants will walk on a treadmill to elicit 430 W of metabolic heat production in the following conditions:
~25.5°C WBGT (31°C, 52% relative humidity) @ 45 min exercise per hour"
15761152|NCT04767347|Other|27.5°C WBGT - Fixed Work Rate|"For four hours, participants will walk on a treadmill to elicit 430 W of metabolic heat production in the following conditions:
~27.5°C WBGT (33°C, 53% relative humidity) @ 30 min exercise per hour"
15761153|NCT04767347|Other|28.5°C WBGT - Fixed Work Rate|"For four hours, participants will walk on a treadmill to elicit 430 W of metabolic heat production in the following conditions:
~28.5°C WBGT (34°C, 54% relative humidity) @ 15 min exercise per hour"
15761154|NCT04767347|Other|35.5°C WBGT - Fixed Work Rate|"For four hours, participants will walk on a treadmill to elicit 430 W of metabolic heat production in the following conditions:
~35.5°C WBGT (40°C, 65% relative humidity) @ 15 min exercise per hour"
15761155|NCT04767347|Other|26.0°C WBGT - Fixed work-to-rest ratio|"For four hours, participants will walk on a treadmill at differing levels of metabolic heat production and environmental conditions (noted below), but at a fixed work-rest ratio of 30 minutes per hour.
~26.0°C WBGT (31°C, 55% relative humidity) @ 530 W metabolic heat production"
15761156|NCT04767347|Other|27.5°C WBGT - Fixed work-to-rest ratio|"For four hours, participants will walk on a treadmill at differing levels of metabolic heat production and environmental conditions (noted below), but at a fixed work-rest ratio of 30 minutes per hour.
~27.5°C WBGT (33°C, 53% relative humidity) @ 430 W metabolic heat production"
15761157|NCT04767347|Other|28.5°C WBGT - Fixed work-to-rest ratio|"For four hours, participants will walk on a treadmill at differing levels of metabolic heat production and environmental conditions (noted below), but at a fixed work-rest ratio of 30 minutes per hour.
~28.5°C WBGT (34°C, 54% relative humidity) @ 330 W metabolic heat production"
15761158|NCT04767347|Other|30.5°C WBGT - Fixed work-to-rest ratio|"For four hours, participants will walk on a treadmill at differing levels of metabolic heat production and environmental conditions (noted below), but at a fixed work-rest ratio of 30 minutes per hour.
~30.5°C WBGT (36°C, 55% relative humidity) @ 230 W metabolic heat production"
15761159|NCT04767347|Other|35.5°C WBGT - Fixed work-to-rest ratio|"For four hours, participants will walk on a treadmill at differing levels of metabolic heat production and environmental conditions (noted below), but at a fixed work-rest ratio of 30 minutes per hour.
~35.5°C WBGT (40°C, 65% relative humidity) @ 430 W metabolic heat production"
15761160|NCT04767334|Device|Anti-Gravity Treadmill|"Each participant will started with a 5 - 10 minute warm-up on a standard cycle ergometer, manual and therapeutic therapy for upper extremity, and gait training using LBPP. Manual and therapeutic therapy will consist of passive and active ROM, joint mobilization, passive and active stretch, manual resistance exercise, and activities of daily life (ADL). All participants will walk in Alter G one session a day (for 40 min), three days a week, for six weeks. On session one, the Alter G pressure chamber will be set to unload 50% of patient's body weight. On the following sessions, the percentage of unload patient's body weight will be decrease depends on the patient's comfort.
~The physical therapist assistance and treadmill speed will be evaluated and altered based on the patient's capacity. The participants can take a rest whenever his/her need during walking. The rest time will be measured and documented."
15761161|NCT04767321|Drug|LTX-109 gel, 3% w/w|LTX-109 gel will be applied topically to both nostrils by a qualified health professional. On each dosing occasion, a large drop of IMP will be applied into each nostril and distributed to cover the whole area of the nostril.
15761162|NCT04767321|Drug|Placebo|Placebo gel will be applied topically to both nostrils by a qualified health professional. On each dosing occasion, a large drop of IMP will be applied into each nostril and distributed to cover the whole area of the nostril.
15761163|NCT04767308|Biological|CT125A cells|Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to manufacture CT125A cells, during which cyclophosphamide and fludarabine will be administered for the purpose of lymphocytes depletion. After lymphodepletion, subjects will receive one dose treatment with CT125A cells by intravenous (IV) infusion. The initial dose of 1×10^6 CAR+ T cells/kg will be infused on day 0.
15761164|NCT04767308|Drug|Cyclophosphamide, fludarabine|Subjects will be given IV infusion of cyclophosphamide 500 mg/m2/day and fludarabine 30 mg/m2/day on days -4, -3 and -2
15761165|NCT04767295|Drug|Camrelizumab, Albumin Paclitaxel, Carboplatin|Intravenous administration of Camrelizumab (200mg/3weeks); Intravenous administration of albumin paclitaxel (260 mg/m2/3weeks); Intravenous administration of carboplatin (AUC 4/3weeks)
15761166|NCT04767282|Other|Fruit and Vegetable Prescription|$15 voucher for fruit and vegetables
15761167|NCT04767269|Drug|Cuminum Cyminum|Cuminum Cyminum mouthwash in chronic gingivitis patients
15761168|NCT04767269|Drug|herbal Mouthwash|herbal mouthwash in chronic gingivitis patients
15761169|NCT04767256|Drug|Dexamethasone and dexmedetomidine|General anesthesia was induced with sufentanil 0.5-0.8 ug/kg, propofol 1.5-2.0 mg/kg, and rocuronium 0.5-1.0 mg/kg. Intravenous dexamethasone 10 mg was injected and a 50-ml syringe containing dexmedetomidine 1 ug/kg in 0.9% saline was infused after induction of general anaesthesia over a 30-min period. Anesthesia was maintained by remifentanil and sevoflurane to keep the Narcotrend index reading between 40 and 60.
15761170|NCT04767256|Drug|Dexmedetomidine|Intravenous dexmedetomidine 1 ug/kg was infused after induction of general anaesthesia over a 30-min period.
15761171|NCT04767256|Other|Ultrasound-guided lumbar erector spinae plane block|The probe was installed in the sagittal axis in the midline at the L3 vertebral level. The spinous processes were ﬁrst visualized, after which the probe was lateralized, and the transverse processes and the erector spinae muscle were visualized approximately 3 cm laterally to the midline. The needle was advanced between the transverse process and the deep fascia of the erector spinae muscle from the caudal to the cranial using in-plane technique. The location of the needle was confirmed with 2mL saline solution, after which 20 mL of 0.4% ropivacaine was administered.
15761172|NCT04767256|Other|PCIA|Intravenous PCA included 0.9% saline with sufentanil and was programmed to run at 2ml with a 1-ml bolus dose and a 10-min lockout time. The patients with VAS more than 4 despite using intravenous PCA were treated with rescue analgesics comprising intravenous parecoxib.
15761201|NCT04767009|Radiation|SBRT|Patients with oligoprogressive NSCLC after treatment with PD-1 inhibitors will be treated with curative-intent SBRT of progressing lesions. The choice of dose-fractionation regimen is at the discretion of the treating radiation oncologist. PD-1 blockade will be withheld one day before the treatment and resumed within 2 weeks after completion of SBRT.
15761173|NCT04767243|Procedure|open flap debridement and filled with A-PRF ( Advanced platelet rich fibrin)|After phase 1 therapy, surgical procedure would be carried out in the selected patients under aseptic conditions. Full thickness mucoperiosteal Kirkland flap would be raised on both buccal and lingual sides using periosteal elevator. Pocket lining epithelium would be removed and a thorough debridement and root planing would be done in the intrabony defect by using Gracey curettes and universal curettes. After placement of A-PRF in bony defect site the mucoperiosteal flaps would be sutured for complete soft tissue closure.
15761174|NCT04767243|Procedure|open flap debridement and filled with Bioactive glass (Perioglas®)|After phase 1 therapy, surgical procedure would be carried out in the selected patients under aseptic conditions. Full thickness mucoperiosteal Kirkland flap would be raised on both buccal and lingual sides using periosteal elevator. Pocket lining epithelium would be removed and a thorough debridement and root planing would be done in the intrabony defect by using Gracey curettes and universal curettes. After placement of perioglas in bony defect site the mucoperiosteal flaps would be sutured for complete soft tissue closure.
15761175|NCT04767243|Drug|open flap debridement and filled Bioactive glass (Perioglas®) and A-PRF|After phase 1 therapy, surgical procedure would be carried out in the selected patients under aseptic conditions. Full thickness mucoperiosteal Kirkland flap would be raised on both buccal and lingual sides using periosteal elevator. Pocket lining epithelium would be removed and a thorough debridement and root planing would be done in the intrabony defect by using Gracey curettes and universal curettes. After placement of perioglas with A-PRF in bony defect site the mucoperiosteal flaps would be sutured for complete soft tissue closure.
15761176|NCT04767230|Other|Dietary Intervention|A heart-healthy diet + daily consumption of 30 grams of flaxseed + 25 mL/day of refined olive oil in adjunct to medical treatment for 3 months
15761177|NCT04767217|Drug|artemether-lumefantrine (ALN)|Assessing the efficacy on current 1st line antimalarial, and an alternative 1st line or 2nd line medicine
15761178|NCT04767217|Drug|dihydroartemisinin-piperaquine (DHA-PPQ)|dihydroartemisinin-piperaquine (DHA-PPQ)
15761179|NCT04767204|Behavioral|peer co-delivered vocational rehabilitation service|The services provided by the trained peers in the work training or problem-solving group, which integrates into a supported employment services
15761180|NCT04767191|Drug|artemether lumefantrine|The drugs are approved and in use by the Kenya Ministry of Health as the 1st and 2nd line treatment for malaria. The study is to assess the continued efficacy of the two drugs in the treatment of uncomplicated malaria.
15761181|NCT04767191|Drug|dihydroartemisinin piperaquine|Antimalarial Combinations
15761182|NCT04767178|Drug|Ibuprofen (Sanofi, Istanbul, Turkey)|Each enrolled infant received oral ibuprofen at a dose of 10 mg/kg 60 min before the onset of the eye examination.
15761183|NCT04767178|Drug|Paracetamol (GlaxoSmithKline, Istanbul, Turkey)|Each enrolled infant received oral paracetamol at a dose of 10 mg/kg 60 min before the onset of the eye examination.
15761184|NCT04767165|Diagnostic Test|MRI|Dynamics of Bone marrow fat fraction by mDixon-quant (%)
15761185|NCT04767152|Diagnostic Test|MRI|The quantitative assessment of MRI parameters, The macromolecular proton fraction (MPF) (%) in brain tissue. Before the start of therapy - the starting point. Point 2. 36 ± 3 days after the start of the therapy. Point 3. After completing three courses of consolidation chemotherapy. Point 4. After confirmation of remission status, optionally provided.
15761186|NCT04767139|Behavioral|counseling for family planning|all mothers presented to infant immunization units of the selected health centers will be counseled for family planning service and referred to the family planning unit if they decided to use.
15761187|NCT04767113|Drug|Heparin sodium|"For infants without thrombosis at enrollment, heparin 1 U/kg/h/line for term infants was used and 0.5 U/kg/h/line for preterm infants. The speed of infusion was 0.5ml/h.
~For infants with thrombosis at enrollment, heparin 10-15 U/kg/h for term infants was used with a target activated partial thromboplastin time 60-70s. Other interventions were at the clinical team's discretion under the local protocol."
15761188|NCT04767113|Drug|Normal saline|For infants enrolled, normal saline was infused at the corresponding speed.
15761189|NCT04767100|Device|Social telepresence robot|Use of a social telepresence robot at home, during three months with the aim of reducing the feeling of loneliness and social isolation among the elderly.
15761190|NCT04767087|Drug|Honey|0.5 gm/Kg/day honey
15761191|NCT04767087|Drug|Nigella sativa seed|40 mg/Kg/day
15761192|NCT04767087|Other|Placebo|empty capsule with sugar water
15761193|NCT04767074|Other|Non-pharmacological Cough control Therapy|"Participants will attend four virtual sessions of 45 to 60 minutes of educational and self-management.
~Session 1 General assessment Prescription and taught of one cough suppression technique.
~Session 2 Cough principles: mechanism, cough reflex, chronic cough, the importance of cough and negative effects of repeated coughing.
~Cough control: identify triggers, use cough suppressions and distractions techniques.
~Session 3 Breathing pattern retraining and laryngeal hygiene: reinforce nasal breathing and pursed lips breathing as strategies to avoid the urge to cough, identification of risk factors for laryngeal dehydration and hydration education.
~Session 4 Reinforcement: Clarification of doubts, techniques' reinforcement and application during daily life situations."
15761194|NCT04767061|Drug|Beta blockers|"The intervention is a two-arm crossover withdrawal/ reversal design (On [A] vs Off [B]) with 4 periods, each period lasting up to 6 weeks. During the On period (A), subjects will be on their beta blocker. During the Off period (B), their beta blockers will be down titrated and subsequently discontinued.
~Subjects will be randomized into either ABAB or BABA sequences."
15761195|NCT04767048|Procedure|bilateral mucosectomy + tonsillectomy|Basic bilateral tongue mucosectomy assisted by robot or laser plus tonsillectomy (unilateral or bilateral at the choice of the investigator)
15761196|NCT04767048|Procedure|tonsillectomy|tonsillectomy (unilateral or bilateral at the choice of the investigator)
15761197|NCT04767035|Drug|midazolam / ketamine sublingual tablet|sublingual tablet
15761200|NCT04767009|Drug|PD-1 Blockade|Patients will receive PD-1 blockade for up to 2 years or until confirmed progression or unacceptable toxicity. PD-1 blockade will be administrated as an intravenous(IV) infusion.
15761202|NCT04766996|Behavioral|Guided mindfulness exercises|Guided Meditation twice daily
15761203|NCT04766996|Other|Self-administered aromatherapy|Self-administered aromatherapy every 6 hours and at bedtime
15761205|NCT04766996|Drug|Tylenol/Acetaminophen|Tylenol/Acetaminophen 1000mg: Pre-operative one dose; Every 8 hours for three weeks after surgery
15761206|NCT04766996|Drug|Pregabalin|"Pregabalin 25mg:
~Twice a day for two weeks before surgery; Pre-operative 25-100 mg; Twice a day for two weeks after surgery"
15761207|NCT04766996|Drug|Prednisone|Prednisone 5mg: Daily for three weeks after surgery
15761208|NCT04766996|Drug|Meloxicam|"Meloxicam 7.5mg:
~Twice a day, with food, for two weeks before surgery; Twice a day, with food, for two weeks after surgery"
15761209|NCT04766996|Drug|Prilosec|"Prilosec 20mg:
~Daily for two weeks before surgery; Daily for for two weeks after surgery"
15761210|NCT04766996|Drug|Tramadol|Rescue pain medicine Tramadol 50mg up to three times a day as needed will be provided for rescue pain
15761211|NCT04766996|Drug|Voltaren|Voltaren 1% topical arthritis gel up to 4 times daily pre-operative only
15761212|NCT04766996|Drug|Zofran|Zofran 4 mg pre-operative
15761213|NCT04766996|Drug|Pepcid|Pepcid 20 mg pre-operative
15761214|NCT04766996|Drug|Reglan|Reglan 10 mg pre-operative
15761215|NCT04766996|Drug|Versed|Versed 2 mg pre-operative
15761216|NCT04766996|Drug|Lidocaine|Lidocaine (preservative free) height based dosing for subarachnoid block intraoperatively
15761217|NCT04766996|Drug|Propofol|Propofol 10-125 mcg/kg/min intraoperative
15761218|NCT04766996|Drug|Ancef|Ancef 2-3 gm weight-based dosing intraoperative
15761219|NCT04766996|Drug|Tranexamic Acid (TXA)|Tranexamic Acid (TXA) 2 gm intraoperative
15761220|NCT04766996|Drug|Decadron|Decadron 10 mg intraoperative
15761221|NCT04766996|Drug|Bupivacaine hydrochloride|Local anaesthetic 0.5% bupivacaine hydrochloride intraoperative
15761222|NCT04766996|Drug|Toradol|Toradol nonsteroidal anti-inflammatory drug max 30 mg intraoperative
15761223|NCT04766983|Diagnostic Test|bronchoalveolar lavage|BAL and ETA are performed as per clinical practice on clinical suspicion of VAP (Johanson score)
15761224|NCT04766970|Behavioral|ADOS-2 Module 4|Assessment in person using standardized Autism Diagnostic Observation Schedule, 2nd Edition (ADOS-2) Module 4.
15761225|NCT04766970|Behavioral|Adapted Telehealth ADOS-2 Module 4|Assessment via telehealth/teleconference platform using an adapted ADOS-2, Module 4 assessment protocol.
15761226|NCT04766957|Device|Idracare|Treatment will last 3 months (12 weeks). The treatment will be applied 2 times a week, preferably at night before going to bed.
15761227|NCT04766944|Other|No intervention|No intervention
15761228|NCT04766931|Drug|FB2001|Subjects will be administered with FB2001 by intravenous (IV) infusion
15761229|NCT04766931|Drug|FB2001 Placebo|Subjects will be administered with FB2001 placebo by intravenous (IV) infusion
15761230|NCT04766918|Procedure|Sono-guided injection with high molecular weight hyaluronic acid|Sono-guided injection with hyaluronic acid (Aragan Plus, 20 mg/2 ml, 3000kDa) between carpal tunnel and median nerve
15761231|NCT04766918|Procedure|Sono-guided injection with low molecular weight hyaluronic acid|Sono-guided injection with hyaluronic acid (ARTZDispo, 25 mg/2 ml, 600-1200kDa) between carpal tunnel and median nerve
15761232|NCT04766905|Procedure|Mini Lateral Shoulder Approach (MLSA)|"The skin incision is about 4 to 5 cm made by the distal acromial edge in sagittal plane, The dissection takes place slightly over the acromial edge proximally and over the origin of the acromial deltoid part (the middle part of deltoid origin) distally.
~After clearly revealing the region of the medial deltoid origin on the acromion, the acromionic deltoid origin is skinned only; of the edge of the acromion, and that maybe accrued by electric knife pen or periosteal elevator, without exposure the clavicular deltoid origin in the front and the deltoid origin on the spine of scapula in the back, the origin of the acromial deltoid is distanced laterally and distally, where the lateral edge, the lower surface of the acromion, under acromial bursa and the rotator cuff are exposed clearly."
15761233|NCT04766892|Drug|Mavacamten|Mavacamten Capsules
15761234|NCT04766879|Device|Transfluthrin|Passive emanator with formulated transfluthrin
15761235|NCT04766879|Device|Placebo|Passive emanator with formulated inert ingredients
15761236|NCT04766866|Diagnostic Test|sFlt1/PlGF screening in maternal blood at 35 to 37 weeks of gestation|A ratio cutoff of >p90th will be used to define low and elevated risk of developing a placental complications of pregnancy and therefore induction of labour will be offered from 37th weeks of gestation
15761237|NCT04766853|Drug|Dexamethasone|Dexamethasone 5mg/ml
15761238|NCT04766853|Drug|Hyaluronic acid|Dexamethasone+Hyaluronic Acid
15761239|NCT04766840|Drug|CAR-T cells|Drug: IM73 CAR-T Cells Drug: Fludarabine Two days before cell infusion, patient will be treated with fludarabine for 3 days Drug: Cyclophosphamide: Two days before cell infusion, patient will be treated with Cyclophosphamide for 3 days
15761240|NCT04766827|Drug|albumin-bound paclitaxel|Paclitaxel for injection (albumin-bound) uses human serum albumin as the carrier to avoid the use of organic solvents for intravenous injection of paclitaxel, reducing the incidence of allergic reactions, and reducing the toxicity of the drug.
15761241|NCT04766801|Procedure|Laparoscopic adjustable gastric banding|Weight-loss surgery, with the use of gastric banding
15761243|NCT04766775|Device|Silver Diamine Fluoride|Silver Diamine Fluoride (Riva Star) which contains silver, fluoride, ammonia and water.
15761244|NCT04766762|Procedure|Acupuncture combined with placebo|This group will include 48 patients. Patients in this group will receive acupuncture combined with placebo. Participants are in the supine position. The bilateral Tianrong (SI 17) acupoints are needled for 1-1.5 inch with the direction tilted back 45±5 degrees. The bilateral Fengchi (GB 20) acupoints are needled for 0.5-1 inch with the direction tilted to nose. The bilateral Neiguan (PC 6) acupoints are also needled for 0.5-1 inch with the straight direction. In addition, 4-6 additional acupoints can be identified according to different syndrome types of patients. The needles are kept for 30 min, the treatment frequency is 3 times per week, and the treatment duration lasts 8 weeks. Meanwhile, the dosage of placebo is 1 capsule twice a day and the treatment duration also lasts 8 weeks.
15761359|NCT04765722|Drug|Mepolizumab|Mepolizumab subcutaneous injection administered 3 times days 0, 28, 56 and 84 during 12 week treatment period.
15761565|NCT04764084|Drug|Niraparib|Niraparib 100mg or 200mg, PO, qd，d1-d21
15761245|NCT04766762|Procedure|Sham acupuncture combined with flunarizine hydrochloride|This group will include 48 patients. Participants in this group will receive sham acupuncture plus flunarizine hydrochloride. Participants are in the supine position and sham acupuncture is conducted. The bilateral Tianrong (SI 17) acupoints, Fengchi (GB 20) acupoints and Neiguan (PC 6) acupoints are selected, and 4-6 additional acupoints can be identified according to the syndrome type of the participants. The needles are kept for 30 min, the treatment frequency is 3 times per week, and the treatment duration lasts 8 weeks. Moreover, the dosage of flunarizine hydrochloride is 5mg twice a day and the treatment duration also lasts 8 weeks.
15761246|NCT04766749|Other|RIPC|RIPC is delivered with a standard blood pressure cuff placed on the upper thigh. The cuffs are inflated to 200 mm Hg and keep inflated for 5 minutes,Then deflated to 0 mmHg and keep uninflated for 5 minutes, This cycle is repeated four times
15761247|NCT04766736|Procedure|Quantification of netrin-1 signals by antibody-based approaches|Samples have been obtained upon curative surgery without any other therapy administered and subsequently characterized by pathologists after FFPE inclusion.
15761250|NCT04766710|Other|Community-based ART delivery (CAD)|The frontline workers to implement the CAD model intervention will be people living with HIV recruited from the community who will plays roles as CAWs. The CAWs will receive intensive training, coaching, and mentoring from their respective ART clinics and implementing partners' field staff on ARV dispensing, drug storage, patient's vital sign assessment and recording, HIV education and counseling, medication adherence, referral systems, mental health, stigma and discrimination, and sexual and reproductive health of people living with HIV. To closely monitor the work of the CAWs, a respective ART clinic team, consisting of an ART counselor and a physician, will be tasked to conduct regular supervision along with the program team of the implementing partners to the community groups at least once a month in the first six months. After the six months, supervisory visits will be extended to once every two months.
15761251|NCT04766710|Other|ART multi-month dispensing (MMD)|The control arm participants will receive routine services under the MMD model based on standard community-based prevention, care, and support practices in Cambodia. The NCHADS has introduced MDD in all ART sites across the country. However, so far, not all ART sites currently operate the MMD. The MMD is designed to help ART service providers implement MMD for eligible patients-that is, patients whose condition is determined to be stable-which will reduce the need for frequent visits and providers' workload. Stable people living with HIV receive care and support from counselors and ARVs at the clinics every four to six months.
15761252|NCT04766697|Behavioral|Risk-Reduction Sessions|The 8-session intervention protocol emphasizes cognitive-behavioral interventions for anger management, conflict resolution, reducing sexual risk behavior, substance use, and enhancement of couple functioning.
15761253|NCT04766684|Device|J-Tip with Xylocaine MPF with placebo cream|J-Tip with 0.25mL of 1% Xylocaine MPF with placebo cream
15761254|NCT04766684|Drug|L.M.X.4 cream with J-Tip saline injection|L.M.X.4 cream with J-Tip saline injection
15761255|NCT04766658|Other|Gargle Phonation|Subjects will gargle water while making sound
15761256|NCT04766658|Other|Water swallow|Subjects will hold water in their mouth for 5 seconds and swallow
15761257|NCT04766645|Device|Robotic assisted intervention|Conventional rehabilitation and Robotic treatment of the upper limb (30 sessions, 5 times a week) using a set of 4 robotic devices: Motore (Humanware); Amadeo, Diego, Pablo (Tyromotion). The training will include motor-cognitive exercises specifically selected to train spatial attention, vision and working memory, praxis, executive function, and speed of processing.
15761258|NCT04766645|Genetic|epigenetic analyses|Epigenetic study: evaluation of methylation levels of ACE2 promoter and miR-200c-3p levels.
15761259|NCT04766645|Diagnostic Test|biochemical analyses|Biochemical analysis: the evaluation of serum levels of angiotensin II, ACE2 and Vitamin D.
15761260|NCT04766632|Device|Brain PET-CT of 18F-DOPA|PET-CT is a nuclear medicine exam with radiopharmaceutical injection of 18F-DOPA for the patient
15761261|NCT04766593|Other|Oncological functional reeducation program|"It will consist of the following actions:
~Prescription of multimodal physical exercise.
~Retraining in activities of daily living."
15761262|NCT04766580|Behavioral|Placebo and nocebo effect|The intervention focuses on the speech and instructions given with each placebo (positive for the placebo effect and negative for the nocebo effect)
15761263|NCT04766567|Procedure|Cesarean section with cesarean myomectomy (serosal)|Serosal or endometrial myomectomy performed during cesarean section
15761264|NCT04766567|Procedure|Cesarean section without myomectomy|Cesarean delivery without performing myoemctomy
15761265|NCT04766554|Device|Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter) and protocol-based interventions|In the intervention group, an alarm threshold below 15% of the baseline rSO2 value will be established. Based on the predetermined algorithm the rSO2 will be maintained at or above 85% of the baseline measurements. If the rSO2 reaches levels below 15% of the baseline values or below 50% in absolute value for over 30 seconds, protocol-based interventions will be performed to restore rSO2 to baseline levels.
15761266|NCT04766541|Other|no intervention|There is no intervention.
15761267|NCT04766528|Other|3 maximal aerobic tests|Maximal aerobic tests will be performed before diet intervention, after the first diet and after the second diet
15761268|NCT04766502|Other|Blood sample (20 ml) and EORTC QLQC30 survey|"Blood sample (20ml) will be taken before and 24h after PIPAC procedure
~EORTC QLQC30 during pre operative consultation and at each post operative consultations"
15761269|NCT04766489|Procedure|Complete Decongtestive Therapy|Patients will be given complete decongestive therapy, which includes decongestive exercises, manual lymphatic drainage, compression therapy(either through short stretch bandaging and/or pneumatic device) and exercise, for 5 days a week and for a mean of 20 sessions. Each session will be of 1 hour duration for compressive therapies(Short stretch bandages will be left on for 23 hours a day), 30 minutes of manual lymphatic drainage, and decongestive exercises 3 times a day for 15 minutes each time.
15761270|NCT04766476|Drug|BMS-963272|Specified dose on specified days
15761271|NCT04766476|Other|Placebo matching BMS-963272|Specified dose on specified days
15761272|NCT04766463|Drug|SHR8554 Injection|SHR8554 Injection; high dose
15761276|NCT04766450|Drug|Acetyl cysteine|NAC exhibits potent anti-oxidant activity in the cell through augmentation of intracellular GSH, which is a major component of the pathways by which cells are protected from OTS, and its direct scavenging activity of free radicals by providing sulfhydryl groups. Additionally, NAC treatment exhibits anti-inﬂammatory effects via inhibition of NF-κB activation and reducing subsequent cytokine production . Mitochondria-protective mechanisms of NAC may also be related to its anti-oxidant and anti-inﬂammatory properties
15761277|NCT04766437|Drug|Prasugrel 10mg|Once daily 10 mg prasugrel for 12 months preceded by a loading dose of 60 mg prasugrel at least 2 hours prior to percutaneous coronary intervention without concurrent aspirin therapy.
15761278|NCT04766424|Behavioral|Sleep extension intervention|Participants will receive a fitbit and 8 weekly sleep-related educational materials via email and telephone coaching to review their sleep tracker data, set goals, trouble shoot any problems, and increase motivation.
15761279|NCT04766424|Behavioral|Health education|Participants will receive 8 weekly health education newsletters delivered via email.
15761280|NCT04766411|Other|Unresisted sprint training|"Particiapants will perform:
~2 sets of 3 x 20m sprint
~1 set of 3 x 30m sprint"
15761281|NCT04766411|Other|Resisted sprint training with load equal to 10% of body weight|"Particiapants will perform:
~2 sets of 3 x 20m sprint
~1 set of 3 x 30m sprint"
15761282|NCT04766411|Other|Resisted sprint training with load equal to 20% of body weight|"Particiapants will perform:
~2 sets of 3 x 20m sprint
~1 set of 3 x 30m sprint"
15761283|NCT04766411|Other|Control trial|Participants will not perform any sprint training protocol
15761286|NCT04766385|Drug|KHK7791|oral administration
15761287|NCT04766372|Other|Behaviour change|Using needs supportive, self-determination theory-based, components to improve the physical activity behaviours of adolescent girls.
15761288|NCT04766359|Drug|Albumin-Bound Paclitaxel|Compare the effectiveness and safety of paclitaxel (albumin-bound) combined with radiotherapy and cisplatin combined with radiotherapy in the treatment of early nasopharyngeal carcinoma.
15761289|NCT04766346|Other|Fortified Cow's Milk-Based Oral Nutritional Supplement|The NS is a fortified cow's milk-based product provided in powdered form that provides the appropriate amount of energy and protein to promote growth in children.
15761290|NCT04766333|Behavioral|Healthcare Worker Focused Outreach|This a focused outreach intervention strategy specifically designed for healthcare workers.
15761291|NCT04766333|Behavioral|Community Organization Led Outreach|This is a standard community engaged outreach approach that has traditionally been used in previous research. Analogous to the standard of care for outreach.
15761292|NCT04766320|Biological|Tumor Infiltrating Lymphocytes (TIL)|Adoptive transfer of 1x10^9-3x10^11 autologous TILs to patients i.v. in 30-120 minutes.
15761293|NCT04766307|Drug|Interleukin-2|Interleukin 2 (IL-2) is a pleiotropic cytokine that is produced after antigen activation and plays crucial roles in the immune response. IL-2 secreted by activated T cells is central to the development of an immune response to infection, promoting the differentiation and proliferation of lymphoid cells. This hydrophobic molecule and the various cytokines that it elicits regulates the behavior of T and B lymphocytes, monocytes/macrophages, natural killer (NK) cells, and neutrophils. IL-2 therapy regimens are expected to limit mycobacterial replication. Early clinical trials with IL-2 demonstrated that IL-2 immunotherapy may be useful in controlling infectious disease.
15761294|NCT04766281|Dietary Supplement|MLC901|This consists of extracts from 9 herbal components in a dark blue/light blue capsule
15761295|NCT04766281|Genetic|Placebo|This consists of a dark brown powder in size 0 dark blue/light blue vegetable capsule
15761296|NCT04766268|Other|Prostate artery embolization|Prostate artery embolization (PAE) is a safe and effective minimally invasive interventional radiology procedure in which intraprostatic vessels are embolized to shrink the size of the prostate gland. LUTS is mainly categorized into irritative, obstructive, and mixed types. This has a variable impact on patients' quality of life by interfering with sleep, activities of daily living, anxiety, mobility, leisure, and effect on sexual activities. This trial aims to determine safety and effectiveness of prostate artery embolization and determine factors associated with improved procedure outcome.
15761297|NCT04766255|Procedure|Soft Tissue graft augmentation|"Donor site:
~SCTG group: The SCTG will be harvested in the palat,In order to extract the same thickness in each grafts a double-bladed knife (separated by 1,5mm) will be used. The donor area will be sutured.
~Recipient site:
~SCTG group: the connective tissue graft will be trimmed to the correct dimensions (10mm height, 12mm length and 1,5mm thick) and placed and secured at the recipient site with a resorbable 5-0 suture CM group: The CM graft (Geistlich Fibro-gide) will be trimmed to the indicated dimensions (10mm height, 12mm length) and placed and secured at the recipient site with resorbable 5-0 suture PADM Group: the ADM (NovoMatrix, Biohorizons, Birmingham AL) graft will be trimmed to the indicated dimensions (10mm height, 12mm length) and placed and secured at the recipient site with resorbable 5-0 suture"
15761298|NCT04766255|Procedure|Implant Placement|A crestal incision will be made in the implant reception area, extending from the distal of the most mesial tooth to the mesial of the most distal tooth. A mucoperiosteal flap will be elevated in the most crestal part of the ridge. The receptor bed will be prepared following the established drilling protocol for the placement of a BioHorizons Tapered Pro Implant (Biohorizons, Birmingham AL). The diameter and length of the implant will be previously established during the implant study. Later a healing abutment will be placed.
15761299|NCT04766242|Other|Spiritual healing|"The spiritual healing will be based on an assessment of the total health situation of the individual patient. Spiritual healing will mainly consist of a treatment where the healers hold their hands for some time at different parts of the patient's body, known as power points, outside the patients clothing. The consultation might also include possible life-style advice. The treatments will last for 45-60 minutes each time."
15761300|NCT04766242|Other|Usual care|The care the general practitioner (GP) prescribe when the patients are diagnosed with moderate depression.
15761301|NCT04766229|Combination Product|Citalopram +/- Gabapentin + Sleepio + support person|All participants will receive citalopram and/or gabapentin to manage vasomotor symptoms of menopause and will get access to digital CBT for insomnia and be asked to identify a support person
15761302|NCT04766216|Other|Patient self-management|Patient makes independent decisions regarding warfarin therapy changes using warfarin dosing tools
15761566|NCT04764084|Drug|Anlotinib|Anlotinib 12mg, PO, qd，d1-d14
15761304|NCT04766203|Behavioral|Treatment of REDS using a holistic treatment arm|This arm aims to treat athletes with REDS symptoms by implementing a holistic, individualized nutrition intervention to improve energy availability and thus restore impaired body function due to REDS.
15761305|NCT04766190|Behavioral|Group 2: The DISCO App|Patients will receive an individually-tailorable cancer treatment cost education and communication intervention delivered on an iPad just prior to meeting with their oncologist.
15761306|NCT04766190|Behavioral|Group 1: Usual Care|Patients randomized to this arm will receive usual care.
15761307|NCT04766190|Behavioral|Group 3: The DISCO App + Booster|Patients will receive an individually-tailorable cancer treatment cost education and communication intervention delivered on an iPad just prior to meeting with their oncologist. Then, 2 months later they will receive an intervention booster in the form of an individually-tailored email to remind patients of the contents of the intervention.
15761308|NCT04766177|Drug|Bumetanide|bumetanide 0.5 mg twice daily
15761309|NCT04766177|Drug|Placebo|placebo tablets twice daily
15761310|NCT04766164|Behavioral|Survey|Data will be obtained via self-report from participants via a one-time Qualtrics survey.
15761311|NCT04766151|Drug|Transdermal glyceryl trinitrate 10mg patches|Transdermal patches applied to skin 30 minutes before cardiac catheterization
15761312|NCT04766151|Drug|Placebo patches|Transdermal placebo patches applied to skin 30 minutes before cardiac catheterization
15761313|NCT04766138|Device|Fecobionics|Fecobionics is a new device to be inserted through the anal canal into rectum for studying defecation
15761314|NCT04766125|Behavioral|Adverse event information|All patients have access to the standard material about adverse events related to the surgery. One arm will additionally receive elaborated adverse event information from a nurse and a surgeon
15761315|NCT04766112|Other|Group I|Group I will receive yang style Tai chi exercises combined with mental imagery training
15761316|NCT04766112|Other|Group II|Group II will receive yang style Tai chi exercise which consist of 10 positions.
15761317|NCT04766099|Other|Childbirth Educational Video|Educational video describing techniques for pushing
15761318|NCT04766086|Biological|Hexavalent Group B streptococcus vaccine|Hexavalent Group B streptococcus vaccine
15761319|NCT04766086|Biological|Tetanus, diphtheria, and acellular pertussis vaccine|Tetanus, diphtheria, and acellular pertussis vaccine
15761320|NCT04766086|Biological|Placebo|Saline control
15761322|NCT04766060|Other|Fluorescent Imaging|Fluorescense imaging used to evaluate blood perfusion
15761323|NCT04766047|Drug|Dexmedetomidine|Administration of dexmedetomidine intraoperatively
15761324|NCT04766034|Behavioral|Simulated Grocery Shopping Exercise|Participants will click a link and simulate a shopping experience by selecting a week's worth of SNAP-eligible groceries for their household in a web-based supermarket platform
15761325|NCT04766021|Drug|Mirabegron|Dose-response effect on thermogenesis
15761326|NCT04766008|Drug|Metformin|Diabetic patients treated with metformin undergoing coronary angiography will not suspend metformin before and after PCI.
15761327|NCT04765995|Drug|HZBio1 0.96mg / kg|HZBio1 will be administered intramuscularly in single ascending doses with starting of 0.96 mg/kg and subsequent doses of 3.0 mg/kg, 6.0 mg/kg ,9.0 mg/kg,and 12mg/kg, respectively.
15761328|NCT04765995|Drug|HZBio1 3mg / kg|HZBio1 will be administered intramuscularly in single ascending doses with starting of 0.96 mg/kg and subsequent doses of 3.0 mg/kg, 6.0 mg/kg ,9.0 mg/kg,and 12mg/kg, respectively.
15761329|NCT04765995|Drug|HZBio1 6mg / kg|HZBio1 will be administered intramuscularly in single ascending doses with starting of 0.96 mg/kg and subsequent doses of 3.0 mg/kg, 6.0 mg/kg ,9.0 mg/kg,and 12mg/kg, respectively.
15761330|NCT04765995|Drug|HZBio1 9mg / kg|HZBio1 will be administered intramuscularly in single ascending doses with starting of 0.96 mg/kg and subsequent doses of 3.0 mg/kg, 6.0 mg/kg ,9.0 mg/kg,and 12mg/kg, respectively.
15761331|NCT04765995|Drug|HZBio1 12mg / kg|HZBio1 will be administered intramuscularly in single ascending doses with starting of 0.96 mg/kg and subsequent doses of 3.0 mg/kg, 6.0 mg/kg ,9.0 mg/kg,and 12mg/kg, respectively.
15761332|NCT04765995|Drug|Placebo|Matching placebo will be administered intramuscularly.
15761333|NCT04765982|Diagnostic Test|Checking diabetes development in follow up at 3 month|An outpatient visit will be planned approximately three months after ICU discharge. At the time of this visit, we will obtain age, BMI, waist circumference, diet, exercise, history of hypertension and family and personal history of elevated blood glucose to calculate the Finnish diabetes risk score (FINDRISC) questionnaire. (28) Oral glucose tolerance test (OGTT) will be performed according to the guidelines of the World Health Organization (WHO) with 75-g glucose load. Diabetes will be diagnosed according to the American Diabetes Association guidelines that stat fasting plasma glucose ≥126 mg/dl(7mmol/L) and/or 2-h plasma glucose during the OGTT ≥200 mg/dl (11.1mmol/L) and/or HbA1c ≥6.5 % (48 mmol/L); impaired glucose tolerance is noted when 2-h plasma glucose during the OGTT is between 140-200 mg/dl (7.7-11.1mmol/L). Impaired fasting glucose defined as fasting plasma glucose between 100-126 mg/dl (55.7mmol/L). (29)
15761334|NCT04765956|Device|Drug-eluting balloon treatment|Drug-eluting balloon (DEB) treatment of lipid-rich plaque
15761335|NCT04765943|Device|Implantable Loop Recorder implant|Patients will be undergone to an Implantable Loop Recorder implant and monitored for the next 6 months.They will then undergo a cardiac MRI and an ICD will be implanted according to clinical practice guidelines. A minimum follow-up of 2 years is scheduled.
15761336|NCT04765930|Other|Q-switched nd:YAG laser toning|Q-switched nd:YAG laser toning for melasma.
15761337|NCT04765917|Other|Selected physical Therapy program|"-Facilitation of balance reactions from standing position including: Standing on one leg, weight shifting from standing position, stoop and recover from standing, squat from standing, standing on balance board and pushing the child in different directions.
~Facilitation of counterpoising mechanism through instructing the child to kick ball from standing position as well as catching and throwing ball with his hands.
~Strengthening exercises for weakened muscles in upper and lower limbs muscle.
~Strengthening exercises for back and abdominal muscles.
~Stretching exercises for tight muscles in upper and lower limbs.
~Gait training activities for correction of gait pattern including: walking on balance beam, walking on balance board, walking on uneven surface, walking using different obstacles (rolls, wedges, stepper) and walking up and down stairs.
~Jumping in place and jumping a board."
15761338|NCT04765917|Other|Motor imagery training program|"As a preparation each child will be shown a video of 5 minutes of normal movements.
~They will be positioned in a comfortable position. The screen is in the child's visual field. Children will be asked to close their eyes and imagine they will perform the physically practiced task for 10 minutes, similar to one shown in the video. Sequence of the task will be verbally explained to the child for better recalling of sensations in muscles during the movements. During the entire exercise schedule child's attention will be focused on the position, and movement of their body, on proprioceptive inputs coming from the leg muscles and on the tactile sensations of foot floor contact.
~Thereafter, the child will be asked to perform the sequence of tasks, rehearsed mentally for 20 minutes."
15761339|NCT04765904|Procedure|SDF|1)Dry with cotton to affected tooth surfaces 2) Apply the SDF material 3)Dry with a gentle flow of compressed air for at least one minute. and Remove excess SDF with gauze
15761340|NCT04765904|Procedure|Hall technique|Orthodontic separator being stretched between two pieces of floss, then placed between the contact points of primary molars (for five days.) 2)The correct size of crown will not impinge on the teeth on either side, and a slight 'spring back' will be felt when the PMC is gently pushed up
15761341|NCT04765891|Other|Positional release therapy|Positional release therapy was administered in the upper trapezius muscle. The muscle was placed in a shortened position with light pressure and held for 90 seconds per treatment location.
15761342|NCT04765891|Other|Therapeutic Massage|Participants underwent a petrissage type massage for 5 minutes at the site of the trigger point in the upper trapezius.
15761343|NCT04765878|Device|RespirAq Humidification|Humidifier
15761344|NCT04765865|Other|SHAKE Package|The SHAKE (Surveillance of salt intake, Harness industry, Adopt standards for labelling and marketing, Knowledge to empower consumers, and Environments to promote health eating) package is a WHO Best Buy and is recently implemented within Nigeria by the Nigerian Agency for Food and Drug Administration and Control (NAFDAC).
15761345|NCT04765852|Other|High dose probiotic supplement|One probiotic stick pack will be dissolved in 10 mL lukewarm formula milk or breastmilk at body temperature. The dissolved supplement will be fed orally, preferably in the morning, starting on Day 1 until Day 56.
15761346|NCT04765852|Other|Low dose probiotic supplement|One probiotic stick pack will be dissolved in 10 mL lukewarm formula milk or breastmilk at body temperature. The dissolved supplement will be fed orally, preferably in the morning, starting on Day 1 until Day 56.
15761347|NCT04765852|Other|Placebo|One placebo stick pack will be dissolved in 10 mL lukewarm formula milk or breastmilk at body temperature. The dissolved supplement will be fed orally, preferably in the morning, starting on Day 1 until Day 56.
15761348|NCT04765839|Other|Educational, culturally appropriate COVID-19 messages|Educational, culturally appropriate COVID-19 messages will be developed and shared by RHCP.
15761349|NCT04765826|Procedure|Autologous mini punch grafting|"All the medications will be administered for 3 months prior to surgery in addition to twice-weekly NB-UVB sessions following its standard protocol.and all patients will continue the treatment till the end of the follow up period Only stable non-responsive or poorly responsive patients (<25% according to VASI score vitiligo area severity index) and image J measurement during the 1st 3 months phase will be included.
~. Chosen lesions in all included patient's groups will undergo mini-punch grafting Mini punch grafting: Skin grafts will be harvested from the anesthetized (local inﬁltration of 2% lignocaine) donor site (the anterolateral aspect of the thigh, using 1mm sterile disposable punches. The grafts obtained will be placed in the slots made by removing the vitiliginous skin using 1mm punches at the recipient site"
15761350|NCT04765813|Behavioral|Cognitive-behavioral treatment to quit smoking along with an App with active therapeutic components|"Cognitive-behavioral smoking cessation treatment components will be: treatment contract, self-report and graphic representation of cigarette consumption, information about tobacco, stimulus control, activities for the avoidance of withdrawal syndrome, physiological feedback (CO in expired air) on cigarette consumption, nicotine fading (change of cigarette brands each week progressively decreasing the intake of nicotine and tar), and relapse-prevention strategies (assertion training, problem-solving training, change tobacco-related misconceptions, management of anxiety and anger, exercise, weight control, self-reinforcing, and changing irrational beliefs).
~Participants will use a smartphone App with therapeutic components during the intervention (8 weeks) and follow-up period (time frame: one year)."
15761351|NCT04765813|Behavioral|Cognitive-behavioral treatment to quit smoking along with a control App|"Cognitive-behavioral smoking cessation treatment components will be: treatment contract, self-report and graphic representation of cigarette consumption, information about tobacco, stimulus control, activities for the avoidance of withdrawal syndrome, physiological feedback (CO in expired air) on cigarette consumption, nicotine fading (change of cigarette brands each week progressively decreasing the intake of nicotine and tar), and relapse-prevention strategies (assertion training, problem-solving training, change tobacco-related misconceptions, management of anxiety and anger, exercise, weight control, self-reinforcing, and changing irrational beliefs).
~Participants will use a control smartphone App (only to access session materials) during the intervention period (8 weeks)."
15761352|NCT04765800|Behavioral|weekly sessions of face to face outpatient psychotherapy|according the German Richtlinie des Gemeinsamen Bundesausschusses über die Durchführung der Psychotherapie
15761353|NCT04765787|Drug|Combination of Paracetamol 650mg + Orphenadrine 50mg|In routine practice for pain , combination of Paracetamol 650 mg + Orphenadrine 50mg prescribed for 7-10 days with follow up and as per physician discretion
15761354|NCT04765774|Other|Ekspressive touch|Patients will be divided into three groups. The expressive touch group will touch the patient's hand. The music chosen by the patient will be played in the music group.
15761355|NCT04765761|Device|PLMA with introducer|The pro-seal laryngeal mask airway (PLMA) will be inserted along with introducer tool which will be kept in-situ throughout the duration of positive pressure ventilation
15761356|NCT04765761|Device|PLMA without introducer|The pro-seal laryngeal mask airway (PLMA) will be inserted along with introducer tool which will be removed after insertion and patient will be ventilated using PLMA without the introducer in-situ throughout the duration of positive pressure ventilation
15761357|NCT04765748|Device|Cytosorb|Cytokine filter, which can be used intraoperatively while using a heart lung machine
15761358|NCT04765735|Device|Open-loop testing, Closed-loop testing - External Spinal Cord Stimulator (SCS)|SCS therapy with an external neurostimulator using either open-loop or closed loop algorithm
15761528|NCT04764383|Drug|L-Histidine|1000 mg capsules taken by mouth (PO) twice daily (BID).
15761360|NCT04765722|Drug|Normal Saline|Placebo subcutaneous injection administered 3 times days 0, 28, 56 and 84 during 12 week treatment period.
15761361|NCT04765709|Combination Product|durvalumab plus platinum-based chemotherapy (cisplatin or carboplatin plus vinorelbine or pemetrexed)|Induction therapy: durvalumab plus histology-based chemotherapy regimen (cisplatin or carboplatin plus vinorelbine for squamous histology and pemetrexed for non-squamous histology).
15761362|NCT04765709|Combination Product|Durvalumab plus radiotherapy|Concomitant durvalumab and radiotherapy
15761363|NCT04765709|Biological|durvalumab|Consolidation treatment with durvalumab
15761364|NCT04765696|Other|No intervention is administered|No intervention is administered, the cohort is followed in order to evaluate the impact of housing and relocation on active ageing outcomes.
15761365|NCT04765683|Other|questionnaire|Survey of views on outpatient consultation format
15761366|NCT04765670|Other|Instrument Assisted Soft Tissue Mobilization|Bilateral Instrument assisted soft tissue mobilization application will be applied in a single session to the trapezius and sternocleideomastoideus muscles.
15761367|NCT04765670|Other|Kinesiotape Application|Bilateral Kinesiotape application will be applied in a single session to the trapezius and sternocleideomastoideus muscles.
15761368|NCT04765657|Drug|inclisiran sodium|Subcutaneously injected on Day 1, 90 and 270 (Core Part). Subcutaneously injected on Day 360 and every 6 months thereafter until EOS visit (Extension Part)
15761369|NCT04765657|Drug|Placebo|Subcutaneously injected on Day 1, 90, and 270.
15761370|NCT04765644|Drug|Celecoxib|Two 200 mg capsules per day (400 mg/day) for 7 days
15761371|NCT04765644|Other|Placebo|2 capsules/day for 7 days
15761372|NCT04765644|Other|L-arginine + placebo|L-arginine = Five capsules of 2 mg per day (10 mg/day) for 7 days Placebo = 2 capsules/day for 7 days
15761373|NCT04765644|Other|L-arginine + celecoxib|L-arginine = Five capsules of 2 mg per day (10 mg/day) Celecoxib = Two 200 mg capsules per day (400 mg/day) for 7 days
15761374|NCT04765631|Other|Patients with Type 2 diabetes|No intervention
15761375|NCT04765631|Other|Placebo|Placebo comparator
15761376|NCT04765618|Procedure|bariatric surgery|laparoscopic sleeve gastrectomy,or gastric bypass
15761377|NCT04765605|Device|WeFlow-Tbranch Stent Graft System|The single-embedded branch thoracic aorta stent graft system consists of the thoracic aorta stent graft system and the branch stent system. The main chest embedded stent graft system consists of the main chest embedded stent graft and its system conveyor, and the branch stent system consists of branch stents and its conveyor. The main chest embedded stent graft and the branch stent are pre-installed in the conveyor
15761378|NCT04765592|Device|WeFlow-Arch Modeler Embedded Branch Stent Graft System|The modular embedded aortic arch stent graft system consists of the embedded ascending aorta stent graft system, the arch aorta stent graft system and the branch stent system.
15761379|NCT04765579|Behavioral|visual analogy scala|We will investigate the effect of 4in1 block by questioning the vas score of the patients, its effect on quadriceps strength, and additional analgesia needs for 24 hours.
15761381|NCT04765553|Drug|NI-0501|Emapalumab single i.v infusion (1 mg/kg)
15761382|NCT04765553|Drug|Saline|Saline single i.v infusion
15761383|NCT04765540|Behavioral|Low Intensity Nudges|"A bundle of 'low-intensity' passive interventions, including:
~Large Mirrors & hand-shaped sign posts pointing to the station"
15761384|NCT04765540|Behavioral|High Intensity Activities|"A bundle of 'high-intensity' active interventions delivered for three weeks, including:
~Free soap and free facemasks for handwashing station users, a community message board & general encouragement"
15761385|NCT04765540|Behavioral|BRAC's business-as-usual|A set of community activities to increase awareness of public handwashing stations and the need to use them. This includes in-person group sessions demonstrating hand hygiene as well as stickers and posters placed in the community to alert people to the handwashing stations.
15761386|NCT04765527|Dietary Supplement|Turmeric Strength for Joint|Turmeric-based tablets
15761387|NCT04765527|Dietary Supplement|Placebo|Placebo tablets
15761388|NCT04765514|Other|Biomarker based treatment (Temozolomide monotherapy or Radiotherapy monotherapy)|Temozolomide or Radiotherapy
15761389|NCT04765514|Combination Product|Chemo-Radiotherapy consisting of 40 Gy in 15 daily fractions with concurrent temozolomide.|Temozolomide will be administered at a dose of 75 mg/m2 daily for a total of 21 days. This will be followed by adjuvant temozolomide (150-200 mg/m2 daily for 5 day
15761390|NCT04765501|Other|Survey study|Headache Impact Questionnaire (HIQ) will be applied.
15761391|NCT04765488|Procedure|WashIn /WashOut|"According Wash In / WashOut procedure in study group we stop the supply of sevoflurane to the first signs of awakening and record the level of sevoflurane , then we resume the supply of sevoflurane to the end-tidal concentration of 1 MAC maintain the anesthesia for 5 min and stop the supply of sevoflurane to the first signs of awakening again, then we resume the supply of sevoflurane to the end-tidal concentration of 1 MAC maintain the anesthesia for 5 min and finally ( the third time) stop supplying sevoflurane and extubate patient after recovery of muscle tone, spontaneous breathing and consciousness."
15761392|NCT04765475|Behavioral|Motivational Interviewing|A culturally-tailored brief motivational interviewing (MI) intervention to promote preventive behaviors and COVID-19 testing when experiencing symptoms, and isolation and care-seeking when positive among two important high-risk groups in American Indian and Alaska Native communities-ages 18-34 and elders (ages ≥65 years).
15761393|NCT04765475|Behavioral|COVID-19 Symptom Monitoring System|A daily COVID-19 symptoms (CS) monitoring system with alerts, ways for participants to request home testing after first symptoms, and Geographic Information System (GIS) routing for those responding to alerts.
15761394|NCT04765475|Behavioral|Motivational Interviewing and COVID-19 Symptom Monitoring System|A combination of: 1) a culturally-tailored brief motivational interviewing (MI) intervention to promote preventive behaviors and COVID-19 testing when experiencing symptoms, and isolation and care-seeking when positive among two important high-risk groups in American Indian and Alaska Native communities-ages 18-34 and elders (ages ≥65 years); 2) a daily COVID-19 symptoms (CS) monitoring system with alerts, ways for participants to request home testing after first symptoms, and Geographic Information System (GIS) routing for those responding to alerts
15761395|NCT04765475|Other|Supportive Services|Provision of supportive services such as referrals to needed medical, mental or behavioral health care and delivery of a hygiene kit containing basic hygiene supplies. Participants will also be provided information on COVID-19 and nearby testing locations and basic information about COVID-19, mask wearing, how to prevent the spread in the home and managing stress during COVID-19.
15761396|NCT04765462|Biological|Allogeneic γδ T cells|During Stage 1, Subjects will receive 4-6 cycles of allogeneic γδ T cells with three target dose levels , 2x10^6/kg , 1x10^7/kg ,5x10^7/kg per infusion to determine the safe regimen. The identified safe regimen will be used to further confirm safety and efficacy in Stage 2. Whether chemotherapy should be combined or not depends on the specific condition of the patient.
15761397|NCT04765449|Drug|Cytotoxic T Lymphocytes|Given IV. Cytotoxic T Lymphocytes collected from healthy volunteer donors who have recovered from COVID-19. The T cells are collected, manufactured to be COVID-specific, and stored frozen at Thomas Jefferson University.
15761398|NCT04765436|Biological|PTX-COVID19-B|Sterile solution for injection
15761399|NCT04765436|Biological|Placebo|0.9% sodium chloride (normal saline) injection
15761400|NCT04765423|Device|[F-18] NaF PET/CT|Radiotracer F-18 NaF used on the PET/CT imaging
15761401|NCT04765423|Device|[F-18] fluciclovine PET/CT|F-18 fluciclovine (Axumin ®) used on the PET/CT camera
15761402|NCT04765410|Diagnostic Test|EUS FNA (endoscopic ultrasound fine needle aspiration)|Patients with solid pancreatic masses fulfilling the inclusion and exclusion criteria will receive EUS FNA (endoscopic ultrasound fine needle aspiration).
15761403|NCT04765397|Procedure|Effect of different resectoscope fluids on optic nerve diameter measured by ultrasound|During the operation Blood pressure, pulse minute the number of irrigation solutions used, and intravenous serum amounts, operation time will be saved. If there is an abnormal parameters or increased optic nerve sheath surgical team will be informed.
15761405|NCT04765371|Drug|DEXAMETHASONE|Patients will take 60 mg per day of Prednisolone (40 mg morning and 20 md evening) between D1 to D10
15761406|NCT04765371|Drug|PREDNISOLONE|Patients will take 60 mg per day of Prednisolone (40 mg morning and 20 md evening) between D1 to D10
15761407|NCT04765358|Other|Virtual Clinic|CGM, Clinical Care Support and Behavioral Health Support
15761408|NCT04765332|Other|DLQI and PSO-TARGET QoL grid|At inclusion visit, and after 3 and 12 months, the patient will fill a patient questionnaire containing DLQI and PSO-TARGET QoL grid
15761409|NCT04765319|Behavioral|CPT for PTSD|Evidence based psychotherapy for PTSD
15761410|NCT04765306|Device|Traditional Direct Fascial Closure|Fascial closure using traditional surgical instruments and suture without laparoscopic guidance.
15761411|NCT04765306|Device|Fascial Closure Device|Fascial closure using a fascial closure device under direct laparoscopic guidance.
15761412|NCT04765293|Other|Physical Therapy|Physical Therapy Gravity strengthening exercises vs standard physical therapy
15761413|NCT04765280|Diagnostic Test|Central sensitization inventory|Standardized questionnaire to determine the level of central sensitization. Patients with a score of 40 and above are considered to have central sensitization.
15761414|NCT04765280|Other|Short form-36|Standardized questionnaire to investigate the quality of life in patients. The score of the scale is between 0-100. The higher scores are associated with greater deterioration in quality of life.
15761415|NCT04765280|Other|Istanbul Low Back Pain Disability Index|Standardized questionnaire to investigate the disability in patients with low back pain. The score of the scale is between 0-90. It is accepted that the higher the score, the higher the disability.
15761416|NCT04765280|Other|Disabilities of the Arm, Shoulder and Hand (DASH)|Standardized questionnaire to investigate the disability in patients with upper extremity musculoskeletal disorders. The score of the scale is between 0-100 It is accepted that the higher the score, the higher the disability.
15761417|NCT04765280|Other|Neck Pain and Disability scale|Standardized questionnaire to investigate the disability in patients with neck pain. The score of the scale is between 0-100. It is accepted that the higher the score, the higher the disability.
15761418|NCT04765280|Other|Knee Injury and Osteoarthritis Outcome Score|Standardized questionnaire to investigate the disability in patients with knee pain. The score of the scale is between 0-100It is accepted that the higher the score, the higher the disability.
15761419|NCT04765280|Other|Western Ontario and McMaster Universities Arthritis Index|Standardized questionnaire to investigate the disability in patients with hip osteoarthritis. The score of the scale is between 0-240. It is accepted that the higher the score, the higher the disability.
15761420|NCT04765280|Other|Visual analogue scale|global pain score on a 0 to 10
15761421|NCT04765267|Dietary Supplement|Zinc sulphate heptahydrate|Dietary supplements
15761422|NCT04765254|Other|no intervention as it is an observational study|both groups will be monitored for the disease progress or deterioration and mortality rate
15761423|NCT04765241|Behavioral|Physical Activity|The intervention includes a physical activity prescription, a Polar activity tracker watch, access to a private AYA cancer survivor community through the Polar Flow community platform, mHealth nudges and surveys via text messaging, and regular phone or email contact from study staff.
15761424|NCT04765228|Drug|Pegylated liposomal doxorubicin|Pegylated liposomal doxorubicin 50mg/m2 intravenous infusion on the first day + Anlotinib 12mg/d orally, medication on days 8-21, one cycle every 21 days, 2~4 cycles
15761425|NCT04765228|Drug|Anlotinib|Anlotinib
15761426|NCT04765215|Biological|CoronoVAC|SARS-CoV-2 IgM and IgG will be measured from blood samples between 3-6 weeks after the 2nd dose of vaccination
15761427|NCT04765202|Procedure|AG Tx|The control treatment is meshed autograft applied to a FT burn area
15761428|NCT04765202|Biological|SOMA Tx|The experimental treatment is meshed autograft applied to a FT burn area and covered with SOMA
15761429|NCT04765189|Dietary Supplement|Placebo|Placebo product is 100% maltodextrin. Daily dosage is 500 mg in 2 capsules.
15761430|NCT04765189|Dietary Supplement|Verum A|Verum A is 200 mg of mangosteen extract. Daily dosage is 200 mg in 2 capsules.
15761431|NCT04765189|Dietary Supplement|Verum B|Verum B is 400 mg of mangosteen extract. Daily dosage is 400 mg in 2 capsules.
15761432|NCT04765189|Dietary Supplement|Verum C|Verum C is 200 mg mangosteen extract + 300 mg grape extract. Daily dosage is 500 mg in 2 capsules.
15824809|NCT04245865|Drug|Bevacizumab|5 mg/kg OR 7.5 mg/kg iv
15761433|NCT04765176|Device|Endovascular Repair|Endovascular repair of the infrarenal aorta using a AAA stent graft.
15761434|NCT04765163|Device|Intelligent Operating Handle|Intelligent Operating Handle
15761435|NCT04765150|Procedure|3 Tesla Magnetic Resonance Imaging|Undergo 3T MRI
15761436|NCT04765150|Other|Electronic Health Record Review|Medical charts are reviewed
15761437|NCT04765137|Drug|Atorvastatin Oral Tablet|Atorvastatin pill 40 mg to be taken every night
15761438|NCT04765111|Drug|Acalabrutinib|Given PO
15761439|NCT04765111|Biological|Rituximab|Given IV
15761440|NCT04765098|Drug|Tamoxifen|Tamoxifen 20 mg daily for 3 days then 20 mg BID for 3 days then increase by 20 mg daily every 3 days until 100 mg BID continuously
15761441|NCT04765098|Drug|Etoposide|etoposide 50mg/m2 daily
15761442|NCT04765085|Behavioral|comprehensive behavioral intervention therapy (CBIT)|"Comprehensive behavioral intervention for tics is an extension of habit reversal training. It includes an expanded set of strategies, such as psycho-education about tic disorders, tic awareness training, competing response training, relaxation training, and functional analysis.
~According to the CBIT treatment manual (translated by sun Jinhua and Xu Wen, the author were Douglas W. woods et al., Oxford University Press, New York). The treatments consisted of 8 sessions for 10 weeks The first two phases were 1.5 hours, the last six stages were 1 hour.The treatment process was regularly supervised by a treatment supervisor."
15761443|NCT04765085|Drug|Aripiprazole 5Mg Oral Tablet|Considering the patients with chronic tic disorder (chronic motor or vocal tic disorder or Tourette's disorder), aripiprazole was selected as a single drug with constant dose during the treatment. In case of extrapyramidal side effects, benhexol was given to reduce the extrapyramidal side effects, and the dosage and duration of medication were recorded
15761444|NCT04765072|Behavioral|Survivorship Patient Navigation Intervention|Patient navigator assistance for navigating the healthcare system and locating and utilizing beneficial resources
15761445|NCT04765072|Behavioral|Telehealth Survivorship Visit Intervention|Individualized survivorship care plan
15761446|NCT04765059|Drug|Osimertinib (AZD9291) pemetrexed cisplatin or carboplatin|Randomized patients will receive oral dose of osimertinib with intravenous (IV) pemetrexed plus either IV cisplatin or IV carboplatin
15761447|NCT04765059|Drug|Placebo for osimertinib (AZD9291) pemetrexed cisplatin or carboplatin|Randomized patients will receive oral dose of placebo matching osimertinib with IV pemetrexed plus either IV cisplatin or IV carboplatin
15761448|NCT04765046|Device|Bispectral (BIS™) Complete Monitoring System|The BIS™ Complete Monitoring System is a user-configurable patient monitoring system designed to monitor the hypnotic state of the brain based on the acquisition and processing of EEG signals. The BIS technology converts raw EEG data acquired from the frontal cortex into a single number to measure the level of consciousness, called the BIS index. A bilateral sensor is to be placed on the patient's forehead to collect the EEG signals and transmit them back to the system.
15761449|NCT04765033|Drug|Nebulized 5% Hypertonic saline|nebulized
15761450|NCT04765033|Drug|Placebo|Nebulised
15761451|NCT04765020|Behavioral|Experimental: moderate to high-intensity exercise|"Four parts:
~Initial consultation with recommendations for general physical activity, brochure with exercise recommendations
~Once per week multi-modal group-based exercise (endurance, strength, mobility, coordination)
~Once per week supervised multi-modal individual training session (endurance, strength, mobility, coordination). Intensity: 60-80% of max. HR
~Activity trackers with individual movement goals that will be adjusted every two weeks"
15761452|NCT04765007|Other|mindfulness-based stress reduction|"Eight sessions of two hours and a half, one day per week during eight weeks. In addition, patients will perform a day of intensive silent practice of 6-8 hours of duration.
~The content of each session balances three activities: the presentation of a topic, moments of dialogue and group exploration (using appreciative inquiry) and a Mindfulness practice.
~The sessions will take place in online format, through the google meet application"
15761453|NCT04765007|Other|Minimal intervention|A guided meditation program of eight weeks of duration will be provided to the patients and they will be informed about the procedure and the beneficial effects of the therapy.
15761454|NCT04764994|Device|Armeo®Spring ((Task-oriented upper extremity rehabilitation system)|Armeo®Spring is a functional upper extremity rehabilitation device to provide specific therapy with augmented feedback. The Armeo Spring instrument facilitates intensive task-oriented upper extremity therapy after stroke, traumatic brain injury or other neurological diseases and injuries. It combines an adjustable arm support, with augmented feedback and a large 3D workspace that allows functional therapy exercises in a virtual reality environment.
15761455|NCT04764994|Other|Conventional Physical Therapy Program|This intervention t will include: muscle facilitation exercises, proprioceptive neuromuscular facilitation exercises, strengthening activities, stretching exercises and postural reactions exercises.
15761456|NCT04764981|Other|Essence oils|Consists in olfactory training using essence oils
15761457|NCT04764968|Drug|Dasiglucagon|Abdominal s.c. administration using a multi-dose reusable pen injector
15761458|NCT04764955|Dietary Supplement|Placebo|This product is identical in appearance, taste and texture to the experimental formulation but does not include any vitamin D3.
15761459|NCT04764955|Dietary Supplement|Vitamin D3 (cholecalciferol)|The intervention is an oral tablet containing vitamin D3 (cholecalciferol). Each weekly dose consists of a single tablet. Vitamin D3 content of the dose depends on the intervention group.
15761460|NCT04764942|Drug|Carfilzomib|Given IV
15761461|NCT04764942|Drug|Dexamethasone|Given PO
15761462|NCT04764942|Drug|Pomalidomide|Given PO
15761463|NCT04764942|Other|Quality-of-Life Assessment|Ancillary studies
15761464|NCT04764942|Other|Questionnaire Administration|Ancillary studies
15761465|NCT04764942|Drug|Selinexor|Given PO
15761466|NCT04764929|Device|Helmet CPAP|Vyatil nonpowered oxygen tent system
15761467|NCT04764916|Drug|Liposomal bupivacaine|Liposomal bupivacaine will be used as adductor canal block
15761468|NCT04764916|Drug|Bupivacaine Hydrochloride|This is the facility's standard of care medication for this procedure
15761469|NCT04764903|Other|No intervention|There is no intervention in this study
15761470|NCT04764890|Other|Electroacupuncture|Electroacupuncture in several point
15761471|NCT04764890|Other|Manual therapy|Manual therapy in the lower spine.
15761472|NCT04764877|Other|Osteopathic Manipulative Medicine|Provided 15-20 minute long OMT session for patients in the OMT arm
15761473|NCT04764864|Procedure|Angioembolization|"Via the femoral route, a non-selective pelvic arteriography with a selective embolization of the arterial branches that show direct or indirect signs of injury will be performed.
~In the event of persistent hemodynamic instability after selective embolization, non-selective bilateral embolization of the internal iliac arteries will be evaluated.
~The material used will vary depending on the characteristics of the injury and the availability of the materials."
15761474|NCT04764864|Procedure|Preperitoneal Pelvic Packing|"Pfannestiel incision / infraumbilical laparotomy. Dissection of tissues up to and including the transversalis fascia. Inferior to this and anterior to the peritoneum, the preperitoneal cavity is identified.
~Inclusion of radiopaque laparotomy gauze in each hemipelvis, from the posterior part (anterior to the sacro-iliac joint) to the most anterior in the retropubic position. Subsequently, the closure is carried out to increase the plugging effect.
~A second intervention is required to remove the material in 24-48 hours."
15761475|NCT04764851|Drug|ecopipam HCl ~2mg/kg/day|oral tablet
15761476|NCT04764851|Combination Product|Cohort 1 Probe Cocktail|dextromethorphan, caffeine, omeprazole, and midazolam
15761477|NCT04764851|Combination Product|Cohort 2 Probe Cocktail|dabigatran, pitavastatin, rosuvastatin, atorvastatin, midazolam
15761478|NCT04764851|Combination Product|Cohort 3 Probe Cocktail|bupropion
15761479|NCT04764838|Other|Yoga|"Breath Awareness Training (5 minutes) Asanas (20 minutes)
~Bending sideways in Mountain Stance
~Standing Pelvic Shaking Warrior Stance II Squatting and malasana (wreath pose) Breath awareness in lotus pose (sitting) Cane pose Fixed Butterfly / Angel Pose
~Sitting wide in Angel Pose Cat Pose Tiger Breath Mudra and meditation (10 minutes)"
15761480|NCT04764825|Drug|Methadone|"The dosage administered differ in regards to age and tolerance to opioids:
~0.2 mg/kg: all patients <65 years of age and all patients tolerant to opioids (defined as treatment with opioids (at least the last 7days) exceeding 60 oral morphine milligram equivalents daily.
~0.15 mg/kg: Opioid naive patients > 65 years of age."
15761481|NCT04764825|Drug|Morphine|"The dosage administered differ in regards to age and tolerance to opioids:
~0.2 mg/kg: all patients <65 years of age and all patients tolerant to opioids (defined as treatment with opioids (at least the last 7days) exceeding 60 oral morphine milligram equivalents daily.
~0.15 mg/kg: Opioid naive patients > 65 years of age."
15761483|NCT04764786|Other|EVOO+POLY|a test meal seasoned with extra virgin olive oil rich in polyphenols
15761484|NCT04764786|Other|OO-POLY|a test meal seasoned with olive oil poor in polyphenols
15761485|NCT04764773|Other|No intervention|No intervention
15761486|NCT04764760|Device|Wing shaped Tensiflex prosthesis|Curative inguinal hernia repair techniqque
15761487|NCT04764734|Device|NightOwl|The NightOwl is a finger-mounted home sleep apnea testing device
15761488|NCT04764721|Device|18F-FDG PET-CT|Enrolled patients in Neurocog-Covid will receive a 18F-FDG PET-CT
15761489|NCT04764708|Behavioral|Compassion and Metacognition Based Therapy|The intervention is a Third Wave Cognitive Therapy targeting metacognitive dysfuctions (through Metacognitively Oriented Psychotherapy) and self-criticism (through Compassion Focused Therapy).
15761490|NCT04764708|Behavioral|Cognitive Behavioral Therapy|Standard Cognitive Behavioral Therapy for Personality Disorders plus Standard Psychopharmacological Treatment.
15761491|NCT04764695|Dietary Supplement|Individualized Nutritional Treatment|Pre-test / post-test clinical trial. Children aged 2-14 years in the remission stage of ALL (4-6 weeks post-diagnosis) will participate. The nutritional status will be evaluated using a diagnostic questionnaire (SCAN), habitual diet (ENSANUT consumption frequency questionnaire) and body composition (dilution with deuterium oxide, electrical bioimpedance and anthropometry). Subsequently, an individualized nutritional plan will be implemented for 6 months with the following distribution of nutrients: <30% fat / day, 55-60% carbohydrates and 1-1.5 g protein / kg / day. Every two weeks a new 7-day eating plan will be provided with 5 interchangeable meals, adapting to food intake, percentage of adherence to the nutritional plan, modifications and symptoms related to treatment (nausea, diarrhea, taste alteration, etc.). For hospitalized patients, the options offered by the hospital will be evaluated and adapted to the intervention.
15761492|NCT04764669|Drug|E2027|Oral hypromellose capsules.
15761493|NCT04764656|Drug|Brolucizumab|There is no treatment allocation. Patients administered Brolucizumab by prescription that have started before inclusion of the patient into the study will be enrolled.
15761494|NCT04764643|Drug|N-acetylcysteine solution|use N-acetylcysteine solution to alleviate esophageal irritation caused by Lugol's chromoendoscopy
15761495|NCT04764643|Drug|sodium thiosulfate solution|use sodium thiosulfate solution to alleviate esophageal irritation caused by Lugol's chromoendoscopy
15761496|NCT04764630|Drug|Four naloxone nasal spray doses (1 every 2.5 min)|Four 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min, left nostril at 5 min, right nostril at 7.5 min
15761497|NCT04764630|Drug|Four naloxone nasal spray doses (2 every 2.5 min)|Four 4 mg IN naloxone doses (left and right nostrils at 0 min, left and right nostrils at 2.5 min)
15761498|NCT04764630|Drug|Two naloxone nasal spray doses (1 every 2.5 min)|Two 4 mg IN naloxone doses (left nostril at 0 min, right nostril at 2.5 min)
15761499|NCT04764604|Device|Acapella Choice|3 minutes of exercise consisting of blowing through the device (on setting '5') and phonating at the same time.
15761500|NCT04764604|Device|Tube-in-water|3 minutes of exercise consisting of blowing through a silicone tube (10mm internal diameter) submerged in 5 cm of water whilst phonating at the same time.
15761501|NCT04764591|Other|Lateral sagittal approach|Lateral sagittal approach for ultrasound guided infraclavicular brachial plexus block
15761502|NCT04764591|Other|Costoclavicular approach|Costoclavicular approach for ultrasound guided infraclavicular brachial plexus block
15761503|NCT04764565|Dietary Supplement|Nuun Instant|Contains (per 11 gram serving) the following: 7 grams of carbohydrate, calcium (20mg, 2%DV), sodium (520mg, 23%DV), potassium (385mg, 8%DV), magnesium (8mg, 2%DV), chloride (250mg, 10%DV), and 100% of vitamin C (90mg) and B12 (2.4 mcg).
15761504|NCT04764565|Other|Water|water
15761529|NCT04764383|Drug|Placebo|Microcrystalline cellulose (placebo) 1000 mg capsules taken by mouth (PO) twice daily (BID).
15761530|NCT04764383|Drug|Lodosyn|50 mg capsules taken PO BID.
15761505|NCT04764565|Dietary Supplement|Nuun Electrolyte|Citric Acid, Dextrose, Sodium Bicarbonate, Potassium Bicarbonate, Sodium Carbonate, Natural Flavors, Potassium Chloride, Malic Acid, Magnesium Carbonate, Calcium Carbonate, Stevia Leaf Extract, Beet Powder Color, Safflower Oil. Nuun electrolytes contains (per tablet) the following: 3 grams of carbohydrate, calcium (15 mg, 1%DV), sodium (200 mg, 9%DV), potassium (125mg, 3%DV), magnesium (15mg, 4%DV), and chloride (75mg, 3%DV).
15761506|NCT04764552|Dietary Supplement|Yeahhh Baby Ointment|The ointment consists primarily of coconut oil (98%), with small amounts of herbal ingredients (tanner's bark, slippery root, sweet weed, velvet plant, walnut hulls, kidney root, green ginger, Indian pink, mad dogweed, and nigella seed) thought to reduce inflammation and to promote tissue healing.
15761507|NCT04764552|Other|Coconut oil ointment|Coconut oil ointment with a little olive oil.
15761508|NCT04764539|Behavioral|Video Assisted Speech Therapy (VAST)|6 ASD children between the ages of 4 and 8 who participated in all 14-sessions-long study that utilized the VR-integrated and the tablet-based VAST application. Three subjects received a 3D VR-integrated, bone conduction VAST prototype, while the remaining group of three received a tablet with a 2D version of the software. Sessions were held twice a week with each lasting approximately 15 minutes (i.e. +/- 5 minutes).
15761509|NCT04764526|Other|Protein-enriched ice cream|Offering two protein-enriched ice creams
15761510|NCT04764513|Biological|Ex-vivo expanded γδ T cell infusion|"Phase 1: Patients receive ex-vivo expanded γδ T cell (Dose escalation, 3 cohorts, x5 dose increments between cohorts, 2×10^6、 1×10^7 and 5×10^7 of cells per kg of body weight).
~Phase 2: Patients receive ex-vivo expanded γδ T cell at the maximum tolerated dose determined in Phase 1."
15761511|NCT04764500|Other|examination of stool sample|Each participant provides stool samples before and after travelling, after 2, 4, 6, 8, 10, 12, 16, 20 and 52 weeks. Stool samples will be used for isolating both a) ESBL E. coli strains and b) pan-sensitive E. coli strains. Part of the stool sample is stored for isolation of further E. coli clones and microbiota analysis of the isolation of other microbiota strains. All found Enterobacteriaceae will be screened for additional resistance such as Carbapenem and Colistin. In case of a specific resistance, this will be confirmed with additional phenotypic and genotypic tests such as ROSCO disk and polymerase chain reaction (PCR) based panel and whole genome sequencing in order to detect specific resistance mechanisms and genes. Bacteria will be sequenced using Illumina and Nanopore based sequencing. Bioinformatic analysis will allow to determine the whole bacterial genome with containing resistance genes and also describe the microbiota diversity over time in single individuals.
15761512|NCT04764500|Other|patient questionnaire|Each participant will have to provide a questionnaire before and after travelling, as well after 2, 4, 6, 8, 10, 12, 16, 20 and 52 weeks.
15761513|NCT04764500|Other|examination of blood sample|Each participant will have to provide a blood sample before and after travelling and after 6, 12 and 20 weeks. A serum sample (5mL) for antibody measurement and a 50 ml blood sample for recovery of peripheral blood mononuclear cells (PBMCs in 6 CPTs) for cell mediated immunity will be collected. Serum and PBMCs will allow the analysis of anti-E. coli humoral and cellular responses in order to characterize the individual immune response to specific bacteria over time. Single nucleotide polymorphisms associated with humoral and cellular immune responses will be characterized and linked to immunological and clinical phenotypes and endpoints of the study.
15761514|NCT04764487|Device|KidneyPRO|Web-application for symptoms assessment
15761515|NCT04764487|Other|standard follow-up|usual follow-up
15761516|NCT04764474|Drug|HMPL-306|Administered orally QD in a 28-day continuous dosing treatment cycle
15761517|NCT04764461|Other|Use of customised GROW Charts|Intervention group will follow the same antenatal visit plan and two ultrasounds will be offered (NT 11-13+6 weeks & anomaly scan 19-22 weeks of gestation) in routine. A third trimester scan will not be offered in routine to Intervention group. Serial SFH measurements will be plotted against estimated date of delivery at each review from 26 weeks of gestation on the customized GROW chart already attached in the maternity notes. On each visit patient will be examined after emptying bladder in a semi-recumbent position, using non-elastic tape with cm side hidden; measurement will be taken from the fundus to upper margin of pubic symphysis. Abnormal SFH measurements, when plotted below the 10th or does not follow its trajectory on customized growth charts will be referred for growth scan suspecting SGA. SFH plotted above 90th centile will also be referred for growth scan, as a part of antenatal care.
15761520|NCT04764435|Other|Physician ownership|"The intervention or exposure is whether the dialysis facility was owned by a physician in 2017"
15761521|NCT04764435|Other|Large dialysis organization ownership|"The intervention or exposure is whether the dialysis facility was owned by a large dialysis organization in 2017"
15761522|NCT04764422|Biological|Normal Saline|0.9% normal saline for injection
15761523|NCT04764422|Biological|NDV-HXP-S vaccine|Vaccine NDV-HXP-S, manufactured by GPO with or without adjuvant CpG1018.
15761524|NCT04764409|Procedure|Chemoembolization|Transarterial Chemoembolization (TACE)
15761525|NCT04764409|Procedure|Chemoinfusion|Transarterial Infusion (TAI)
15761526|NCT04764396|Combination Product|Heparin will be used for needle priming (BD PosiFlush™ Pre-Filled Heparin Lock Flush Syringe)|The needle will be flushed with 1 milliliter (mL) of heparin (100 USP/mL) and then flushed with air. The first two passes will be collected for clinical purposes and sent to pathology per standard clinical procedures. Pass 3 will be obtained for research purposes and placed in a separate formalin jar for research. Between passes (after pass 1 and 2) after tissue is extracted from the needle, the needle will be flushed with 1 mL of heparin (100 USP/mL) and flushed with air before next pass is made.
15761527|NCT04764396|Drug|Saline|The first two passes will be collected for clinical purposes and sent to pathology per standard clinical procedures. Between passes and after tissue is extracted from the needle, the needle will be flushed with 1 mL of saline, as per standard clinical practice, and flushed with air before next pass is made. Pass 3 will be taken for research purposes and placed in a separate formalin jar for research. Between passes (after pass 1 and 2) after tissue is extracted from the needle, the needle will be flushed with 1 mL of with 1 mL of saline, as per standard clinical practice, and flushed with air before next pass is made.
15824810|NCT04245865|Drug|Capecitabine|2000 mg/m2 orally daily for two weeks
15761531|NCT04764370|Device|WeFlow-Ach Moduler Embedded Branch Stent Graft System|The modular embedded aortic arch stent graft system consists of the embedded ascending aorta stent graft system, the arch aorta stent graft system and the branch stent system.
15761532|NCT04764357|Device|Paxman Scalp Cooling System|Scalp cooling will begin 30-45 minutes prior to administration of each chemotherapy (45 minutes for those with thick or coarse hair types). Scalp temperature will be maintained at +3°C (37°F) throughout drug administration and for 90-120 minutes after discontinuing the infusion. Scalp cooling will occur with each dose of chemotherapy.
15761533|NCT04764357|Other|Alopecia Assessments|Photographs of the hair will be taken before initiation of chemotherapy (baseline) and at a visit 4 weeks (3-6 week window) after the last dose of chemotherapy.
15761534|NCT04764357|Other|Patient Reported Outcomes Questionnaires|"Selected questions from NCI PRO-CTCAE™, Chemotherapy-Induced Alopecia Distress Scale (CADS), and PediQUEST Memorial Symptom Assessment Scale, at the following time points: baseline, end of chemotherapy administration, and 4 week follow up.
~Tolerability Questionnaire each time the cooling cap is used and at the end of study"
15761535|NCT04764344|Drug|Haloperidol|2.5mg of IV haloperidol will be diluted to 5ml with 0.9% NS and given over 2 minutes IVP
15761536|NCT04764344|Drug|Ondansetron|Ondansetron
15761537|NCT04764331|Device|Revian Red All LED cap|Cap that uses two wavelengths of light, 620 nm and 660 nm will be used once a day for 10 minutes.for treatment
15761538|NCT04764318|Behavioral|Remote patient monitoring for hypertension|The intervention involves making available remote physiologic monitoring services for hypertension patients allowable under Medicare for blood pressure (and weight if desired) when ordered by a patient's clinician.
15761539|NCT04764318|Behavioral|Remote patient monitoring with care management|The intervention involves making available remote physiologic monitoring services for hypertension patients allowable under Medicare for blood pressure (and weight if desired) when ordered by a patient's clinician and providing care management services to support the enrollment and active use of this service.
15761540|NCT04764292|Device|Contrast-enhanced mammography|supplemental breast cancer screening with contrast-enhanced mammography
15761541|NCT04764292|Drug|Iodinated Contrast Media (ICM)|supplemental breast cancer screening with contrast-enhanced mammography
15761542|NCT04764279|Dietary Supplement|OPTIFAST dietary supplement|Participants will use Optifast Nutrition Supplement as previously described
15761543|NCT04764266|Diagnostic Test|Heparansulfate and Syndecan 1|Blood samples will be collected from the patient at 5 different time points. Three perfusate samples will be collected during normothermic machine perfusion (4,9ml each).
15761544|NCT04764253|Behavioral|Modified Sodium Watcher Program + Digital Self-Monitoring|Participants randomized to the experimental group will be asked to follow the modified Sodium Watchers Program intervention along with goal setting for low salt foods. Each participant will be registered to assign a unique ID in the Connected Health Platform developed by the Center on Smart and Connected Health Technologies at UT Health Science Center San Antonio and each account from the individuals' wireless and wearable devices (Fitbit and BP monitor) will be connected to his or her unique ID through this platform. Participants will be instructed to log their activities in real-time, including food intake and in-home BP monitoring using Fitbit and accompanied mobile app and BP monitor. Through the Connected Health Platform, the Fitbit app and BP monitor will transmit the data of the intervention group to the research team.
15761545|NCT04764253|Behavioral|Usual care + Digital Self-Monitoring|Participants randomized to the control group will be asked to follow usual care which is based on their routine medical and nursing care for hypertension that consists of a recommendation to follow a sodium-restricted diet and take medications as prescribed. The participants will receive wireless and wearable devices (Fitbit wristband, BP monitor). Each participant will be registered to assign a unique ID in the Connected Health Platform at the baseline and each account from the individual's wireless and wearable devices (Fitbit and BP monitor) will be connected to their unique ID through this platform. Participants will be instructed to log their activities in real-time, including food intake and in-home BP monitoring using Fitbit and accompanied mobile app and BP monitor.
15761546|NCT04764240|Procedure|R0 resection with lymphadenectomy|Patients received a surgical R0 resection; patients who received an R1 or R2 resection were excluded.
15761547|NCT04764227|Drug|Paclitaxel|paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1, qw*5
15761548|NCT04764227|Drug|Carboplatin|carboplatin AUC=2, ivgtt, d1, qw*5
15761549|NCT04764227|Radiation|Radiotherapy|1.8Gy/d, d1-5/week, 28Fx
15761550|NCT04764214|Drug|3rd generation EGFR-TKI|Osimertinib will be administered orally at the dose of 80 mg once daily.
15761551|NCT04764214|Radiation|Consolidative SBRT|Patients who possess oligoresidual disease after 3rd generation EGFR-TKI therapy will be treated with the intent to ablate all residual disease with consolidative SBRT. The choice of dose-fractionation regimen is at the discretion of the treating radiation oncologist. TKI will be continued during and after consolidative SBRT until disease progression or intolerable toxicity.
15761552|NCT04764201|Drug|HIP2001|Test drug
15761553|NCT04764201|Drug|HGP2001|Reference drug
15761555|NCT04764175|Behavioral|Telephone All Nations Breath of Life|Same as described above.
15761556|NCT04764175|Behavioral|Comparison Program|Same as described above.
15761557|NCT04764162|Dietary Supplement|Choline capsule|Participants will consume 1000 mg (2 x 500 mg) of choline bitartrate (over-the-counter supplement) for 28 consecutive days. They will continue to consume 1000 mg of choline bitartrate during the post-testing period.
15761558|NCT04764162|Dietary Supplement|Placebo capsule|Participants will consume 1000 mg (2 x 500 mg) of placebo (maltodextrin) for 28 consecutive days. They will continue to consume 1000 mg of placebo during the post-testing period.
15761559|NCT04764136|Device|Scoliometer (scolioscope)|Individuals with scoliosis will participate in this study. The device will be used to determine spinal rotation on the transverse plane. Repeated measures will be taken.
15761560|NCT04764123|Diagnostic Test|AVNRT mapping|AV annuli mapping during AVNRT
15761561|NCT04764110|Dietary Supplement|Cyplexinol|partially hydrolyzed Collagen and its associated proteins including Bone Morphogenetic Proteins (BMPs)
15761562|NCT04764110|Other|Placebo|Maltodextrin
15761567|NCT04764071|Procedure|percutaneous nephrolithotomy|percutaneous access of the desired calyx is achieved under fluoroscopic guidance with the use of an 18-gauge needle and a guidewire passage. Tract dilation is accomplished by using Amplatz dilators up to 30F.
15761568|NCT04764071|Procedure|ultra-mini percutaneous nephrolithotomy|percutaneous access of the desired calyx is achieved under fluoroscopic guidance with the use of an 18-gauge needle and a guidewire passage. Tract dilation is accomplished by using Amplatz dilators up to 12-14 F fascial dilator was used to dilate the nephrostomy tract to pass the 13 F semi-rigid plastic sheath.
15761569|NCT04764058|Drug|Tienam 500|Imipenem and cilastatin sodium
15761570|NCT04764058|Device|Infusion|Health caregivers give the drug to the patients and monitoring the infusion rate
15761571|NCT04764045|Drug|Ropivacaine|Injection of 1 ml Ropivacaine in all trigger points in and around scar. Injection of 1 ml saline in all trigger points in and around scar.
15761572|NCT04764032|Diagnostic Test|Echocardiography|Echocardiography will be undertaken by a range of appropriately competent practitioners including; intensive care clinicians, cardiologists and specialist echocardiographers. Imaging obtained will be in keeping with the protocol required for a Focused Intensive Care Echo (FICE) scan and should include ECG monitoring at all times. A focused dataset will be used to answer the primary outcome. If available and the echocardiographers competency and experience permit, further measures of RV function will be obtained at this time.
15761573|NCT04764019|Diagnostic Test|High resolution intestinal manometry|Evaluation of intestinal manometry by the use a high resolution intestinal manometry catheter with 34 closely spaced sensors.
15761574|NCT04764006|Drug|Surufatinib|Surufatinib(250mg ,qd,po)+Sintilimab(200mg,q3w,iv),21 days for a cycle.The curative effect was evaluated every 8 weeks.
15761575|NCT04763993|Procedure|Roux-en-Y-Gastric bypass, Sleeve gastrectomy|RYGBP consists in creating a small gastric pouch along the little curvature of the stomach, followed by the section of the small bowel. The restoration of the gastro-intestinal tract is achieved by performing a gastro-jejunal and a jejuno-jejunal anastomosis, giving this procedure the characteristic aspect of a Y. Also, for RYGBP the laparoscopic approach requires the placement of 5 trocars in the upper part of the abdomen.
15761576|NCT04763993|Procedure|SG|SG consists in removing the fundus and the body of the stomach, along the greater curvature. To perform it with a laparoscopic approach, we create the pneumoperitoneum with Veress needle and place 5 trocars in the upper part of the abdomen. The first step is the dissection of the greater curvature of the stomach, that starts at 6 centimetres from pylorus and it's conducted up to the angle of His, freeing the fundus and exposing the left pillar. A 38 Fr bougie is placed inside the stomach to calibrate its section. After it is carried out, the specimen is removed from the greater trocar site.
15761577|NCT04763980|Other|Educational Intervention|Participate in educational session with health coach
15761578|NCT04763980|Other|Genetic Testing|Undergo genetic testing
15761579|NCT04763980|Other|Survey Administration|Complete survey
15761580|NCT04763967|Device|PedSCath Pediatric Urinary Catheter|PedSCath Pediatric Sampling Catheter is a pediatric sampling catheter. The product is supplied as a catheter and syringe. PedSCath Pediatric Sampling Catheter is manufactured by Medical Murray Inc. for Big Blue Biotech. The device consists of a blend of LDPE/Elvax/Crodamide.
15761581|NCT04763967|Device|Standard of Care|Current Standard of Care for pediatric patients
15761582|NCT04763954|Other|Rethink therapeutic game|The Rethink therapeutic game is a 7 levels online game developed and tested for children. Each level is based on a specific skill and its efficiency has been previously studies in children.
15761584|NCT04763928|Drug|Venetoclax+Decitabine|"Patients will receive treatment with a combination of decitabine and venetoclax as follows:
~Decitabine 20 mg/sqm intravenously on days 1 to 5 of 28-days courses
~Venetoclax 400 mg per day orally on days 1 to 28 of 28-days courses; a dose escalation period is provided at first cycle (ramp-up) in which VEN is administered as follows: 100 mg on day -2, 200 mg on day -1, and 400 mg on day 1, a dose that is continued subsequently, daily, for 28-day cycles.
~In case of achievement of response, the treatment will be continued until disease progression or death by other causes."
15761585|NCT04763915|Other|Correlative Studies (Survey)|Administer surveys
15761586|NCT04763915|Other|Correlative Studies (Interview)|In-depth interviews among a subset of participants after the 12-month follow-up survey to either: 1) determine additional resources and tailored message that would be helpful; or 2) assess the adaptive intervention
15761587|NCT04763915|Behavioral|GeneSHARE|Access to GeneSHARE, a web-based toolkit which includes interactive and narrative components to enhance FC of genetic test results.
15761588|NCT04763915|Behavioral|LivingLabReport|Access to LivingLabReport, a website containing multiple resources including a summary of the patient's genetic test results, condition-specific information, recommended CRM, and information on accessing CRM services.
15761589|NCT04763915|Behavioral|Standard-of-care & Adaptive Intervention|Receive standard-of-care from their treating healthcare provider. A subset of individuals will also be asked to test and pilot the adaptive intervention, which will consist of tailored resources to promote CRM and FC, after the 12-month follow-up survey.
15761591|NCT04763889|Behavioral|CBT|CBT for those with an allergy and anxiety
15761592|NCT04763876|Drug|Ketorolac Injection 15 mg|A single dose of 15 mg ketorolac administered intramuscularly.
15761593|NCT04763876|Drug|Ketorolac Injection 60 mg|A single dose of 60 mg ketorolac administered intramuscularly.
15761594|NCT04763863|Other|Body Assessment Tool|Assessment tool to evaluate stoma to find proper ostomy products
15761595|NCT04763850|Other|Decline Walking with real-time Feedback|Participants are walking decline with self-paced speed on an instrumented treadmill with virtual reality projection under three conditions: without instruction, with instruction for an internal focus of attention and with real-time feedback of their frontal knee alignment
15761596|NCT04763837|Device|Intraureteral stent|This intervention involves the placement of an intraureteral stent, a tube that drains urine from the kidney to the bladder and has a loop of tube only in the kidney and NOT in the bladder. The distal end of the tube will stay in the ureter just proximal to the opening to the bladder.
15762235|NCT04758910|Device|T-piece|A 30-minute spontaneous breathing trial using T-piece via tracheostomy.
15761597|NCT04763837|Device|Conventional Double-J stent|This intervention involves the placement of a conventional double-J stent, a tube that drains urine from the kidney to the bladder and has a loop of tube in both the kidney and in the bladder.
15761598|NCT04763824|Behavioral|Telementoring with Practice Facilitation|We are attempting to provide education and encourage practice change
15761599|NCT04763811|Other|Focus groups|discussion between participants about representations of health, dependance, fragility, and new technologies
15761600|NCT04763811|Other|Individual interviews|Discussion between the searcher and the participant about representations of captors, discretion of captors, wish about feed-backs of captors
15761601|NCT04763798|Other|Straight-leg-raise (SLR)|The stretched lower limb was on a mobile support and the contralateral limb was stabilized with a belt on the bench. For the SLR, the knee was kept in full extension and then, hip flexion was performed until a marked resistance. All stretching modalities were applied until a marked resistance was felt by the physical therapist (end-feel) or until the point of maximal tolerance referred by subjects.The stretch lasted 30 seconds followed by 15 seconds rest period and the procedure was repeated 5 times. Each stretching was applied for 5 minutes
15761602|NCT04763798|Other|Passive Knee extension test (PKE)|"The stretched lower limb was on a mobile support and the contralateral limb was stabilized with a belt on the bench. For the PKE, the hip was kept in 90º flexion and then, knee extension was performed. All stretching modalities were applied until a marked resistance was felt by the physical therapist (end-feel) or until the point of maximal tolerance referred by subjects.
~The stretches lasted 30 seconds followed by 15 seconds rest period and the procedure was repeated 5 times. Each stretching was applied for 5 minutes"
15761603|NCT04763798|Other|Maximum hip flexion (MHF)|"The stretched lower limb was on a mobile support and the contralateral limb was stabilized with a belt on the bench. For MHF, a maximal hip flexion was performed and then, knee extension was applied. All stretching modalities were applied until a marked resistance was felt by the physical therapist (end-feel) or until the point of maximal tolerance referred by subjects.
~The stretches lasted 30 seconds followed by 15 seconds rest period and the procedure was repeated 5 times. Each stretching was applied for 5 minutes"
15761604|NCT04763785|Device|Corneal tomography with Eyestar 900|Non-invasive corneal tomography to develop an imaging analysis algorithm for keratoconus corneas
15761605|NCT04763785|Device|Corneal tomography with Pentacam|Non-invasive corneal tomography to develop an imaging analysis algorithm for keratoconus corneas
15761606|NCT04763785|Device|Biometry with IOL-Master|Non-invasive biometry for presurgical intraocular lens calculation
15761607|NCT04763785|Other|retrospective analysis, no intervention|retrospective analysis of 4500 existing, fully anonymised picture data
15761608|NCT04763772|Diagnostic Test|Body Fat Distribution Imaging Report|Those randomized to body fat distribution imaging will be scanned on a 1.5 Tesla Siemens Aera MRI scanner (Siemens, Erlangen, Germany), located in the Center for Advanced Heart and Vascular Care using a 6-minute dual-echo Dixon Vibe protocol providing a water and fat separated volumetric data set covering neck to knees, and a multiecho Dixon acquisition for proton density fat fraction assessment in the liver. Images of the liver will be acquired using a 16-channel SENSE extra large Torso coil and images from the rest of the body will be acquired using the body coil. Volumetric imaging datasets of the body derived by MRI will be generated and adipose tissue/fat depots will be quantified: abdominal subcutaneous compartment (ASAT), visceral compartment (VAT), and hips and buttocks (lower body fat); proton density fat fraction of the liver (i.e. hepatic steatosis) as well as the quality of lean (skeletal muscle) including muscle volume and degree of fat infiltration.
15761609|NCT04763772|Diagnostic Test|Basic Weight Information|Body weight and body mass index
15761610|NCT04763772|Behavioral|Patient Provided|Body weight/fat distribution information will be provided directly to the patient
15761611|NCT04763772|Behavioral|Physician Provided|Body weight/fat distribution information will be provided directly to the physician
15761612|NCT04763759|Drug|TRL1068, a human monoclonal antibody|A human IgG1κ (G1m1,17 (z,a); Km3 allotype) monoclonal antibody
15761613|NCT04763746|Device|Lifelight Data Collect Sub-protocol 1|"Study nurse 1 will announce when the 60-second period of Lifelight® measurement begins and ends, guided by the timer on the software. They will observe the oxygen saturation measurements during this 60-second measurement period, noting down the first reading displayed at 0, 30 and 60 seconds. The three oxygen saturation readings should be averaged to generate a single, average oxygen saturation reading.
~Study nurse 2 will operate the automatic sphygmomanometer upon hearing from study nurse 1 that the 60-second measurement period has begun. Study nurse 2 will then spend the remaining measurement period observing the heart rate measurements and note the reading displayed after 0, 30 and 60 seconds. The three heart rate readings should be averaged to generate a single, average heart rate reading.
~This sub-protocol will be repeated twice more to generate three sets of blood pressure, heart rate and oxygen saturation measurements and three concurrent video datasets."
15761614|NCT04763746|Device|Lifelight Data Collect Sub-protocol 2|"Study nurse 1 will announce when the 60-second period of Lifelight® measurement begins and ends, guided by the timer on the software. They will observe the oxygen saturation measurements during this 60-second measurement period noting down the first reading displayed at 0, 30 and 60 seconds timepoints. The three oxygen saturation readings should be averaged to generate a single, average oxygen saturation reading.
~Study nurse 2 will be directed by the announcement of study nurse 1 to begin and end manually counting observed inspirations by watching chest rises throughout the full 60-second period. According to the results of the quality improvement initiative, Study nurse 2 may place their hand on the participant's chest to increase the accuracy of their manual counting.
~This sub-protocol will be repeated once more to generate two sets of respiratory rate and oxygen saturation measurements and two concurrent video datasets."
15761615|NCT04763746|Device|Lifelight Data Collect Sub-protocol 3|"The study nurse will observe the oxygen saturation measurements during this 60-second measurement period indicated by the timer on the software. They will note down the first reading displayed after 0, 30 and 60 seconds. The three oxygen saturation readings should be averaged to generate a single, average oxygen saturation reading for the 60-second period.
~This sub-protocol will be repeated once more to generate two sets of oxygen saturation measurements and two concurrent video datasets."
15761641|NCT04763447|Other|Attempt to withdrawal OMA treatment|Patients will be told to stop abruptly (no progressive decrease of the dose) their Omalizumab treatment and they will not be prescribed new OMA. In case of loss of control, pulmonologist can adapt asthma treatment, as in usual care. In that case, OMA can be prescribed for a second line
15761616|NCT04763746|Device|Lifelight Data Collect Sub-protocol 4|"Study nurse 1 will announce when the 60-second period of Lifelight® measurement begins and ends, guided by the timer on the software. They will manually count observed inspirations by watching chest rises throughout the 60-second period. They may place their hand on the participant's chest to increase the accuracy of manual counting.
~Study nurse 2 will operate a standard automatic sphygmomanometer and clinical finger clip sensor upon hearing from Study nurse 1 that the 60-second measurement period has begun. Study nurse 2 will then spend the remaining measurement period observing these measurements and note the readings displayed after 0, 30 and 60 seconds. The three heart rate and three oxygen saturation readings will each be averaged to generate a single, average reading.
~This sub-protocol will be repeated twice more to generate three sets of blood pressure, heart rate, respiratory and oxygen saturation measurements and three concurrent video datasets."
15761617|NCT04763733|Other|laparoscopic splenectomy|surgical
15761618|NCT04763720|Behavioral|Dyadic Developmental Psychotherapy|DDP involves approximately twenty sessions with the family, conducted by a trained DDP therapist. DDP is developed to treat trauma-related and attachment difficulties. DDP is not a manualized treatment but involves using a set of core communication techniques (termed PACE; Playfulness, Acceptance, Curiosity and Empathy).
15761619|NCT04763694|Device|Multifocal soft contact lenses|Myopic subjects wore multifocal soft contact lenses for 12 months
15761620|NCT04763681|Behavioral|Couple HOPES Guided, Internet-Delivered, Self-Help Intervention|Couple HOPES is a guided self-help intervention for individuals with PTSD and their partners based on Cognitive-Behavioral Conjoint Therapy for PTSD (Monson & Fredman, 2012). This intervention consists of text and video-based content across seven intervention modules and phone and online-based coaching sessions with a paraprofessional. Participants are able to complete these modules in their own home or private location of their choosing. The primary outcomes are PTSD symptoms, relationship satisfaction, and the mental health and wellbeing of partners of those with PTSD.
15761621|NCT04763668|Other|Pregnant HIV positive women on ARTs|Cardiovascular disease risk in pregnant HIV positive women on ARTs
15761622|NCT04763668|Other|Babies born to HIV positive mothers on ARTs|cardiovascular disease risk in the offspring of HIV positive mothers on ARTs
15761623|NCT04763655|Diagnostic Test|clinical and neuropsychological testing|Patients are monitored with Brief Psychiatric Rating Scale (BPRS) weekly and structural and functional MRI and MATRICS battery before and at the end of the course of the study
15761624|NCT04763642|Procedure|pancreaticoduodenectomy|Robotic Whipple operation Open Whipple operation Laparoscopic Whipple operation
15761625|NCT04763629|Other|Physical exercise|Patients of both arms will undergo two different modalities of exercise during the 12 weeks study period.
15761626|NCT04763616|Drug|Isatuximab|The treatment cycle will be repeated up to 2 years. If a patient shows disease progression or unacceptable toxicity, the study treatment will be discontinued and followed up for efficacy and safety after the discontinuation of study treatment.
15761627|NCT04763616|Drug|Cemiplimab|The treatment cycle will be repeated up to 2 years. If a patient shows disease progression or unacceptable toxicity, the study treatment will be discontinued and followed up for efficacy and safety after the discontinuation of study treatment.
15761628|NCT04763590|Behavioral|Cognitive Behavioral Therapy|"This study focuses on patients who are on a mechanical ventilator and who have been medically cleared to come off of it. The purpose of the study is to learn more about the possible influence of cognitive behavioral therapy in helping patients who are having some trouble getting off of the ventilator. Cognitive behavioral therapy is a highly effective intervention for anxiety and the investigators are evaluating whether cognitive behavioral therapy might be helpful in cases where it is difficult to come off of the ventilator.
~Cognitive behavioral therapy is experimental for mechanical ventilation assistance as no research to date has evaluated whether it might be helpful."
15761629|NCT04763577|Other|Assay of Bradykinin-degradating enzymes.|Aminopeptidase P activity assay; Dipeptidyl peptidase IV activity assay; Angiotensin Converting Enzyme activity assay; MME gene polymorphisme exploration.
15761630|NCT04763564|Drug|Liraglutide Pen Injector|Treatment will be initiated at 0.6 mg per day for one week. The patient will be instructed to increase the dose to 1.2/day and 1.8 mg /day in week 2 and in week 3, respectively. From week 3 after the start of the drug until week 6 the patient will apply 1.8 mg/day liraglutide. In case of intolerance (e.g. occurrence of refractory nausea) at a higher dose (e.g. 1.8 mg daily, the highest dose in this trial) liraglutide can be reduced to the previous level.
15761631|NCT04763564|Drug|Placebo Pen Injector|Matching placebo pens used to administer normal saline in the same fashion as for liraglutide
15761632|NCT04763538|Other|Standard of care|Patients are treated according to the standard of care for each individual disease.
15761633|NCT04763525|Behavioral|Pythagorean Self-Awareness Intervention(PSAI)|The PSAI is a mental, stress-management technique that promotes self-awareness, cognitive reconstruction and self-improvement based on the Golden Verses moral framework of the ancient Greek philosopher Pythagoras. The individual must practice the technique twice daily( at bed-time and in the morning, every day, at home) and through a 3-stage internal dialogue (recall of daily events, inspection of related thoughts and emotions and self-appraisal)is encouraged to detect wrong choices and unhealthy behaviours and initiate self-correction towards a healthier lifestyle.
15761634|NCT04763512|Dietary Supplement|Intact Cow's Milk Protein Formula|Study product will be provided as powder, reconstituted with water by parents/caregivers according to label instructions, and consumed orally. Study participants will continue this feeding regimen for 4 months.
15761635|NCT04763512|Dietary Supplement|Partially Hydrolysed Whey Formula|Study product will be provided as powder, reconstituted with water by parents/caregivers according to label instructions, and consumed orally. Study participants will continue this feeding regimen for 16 months.
15761636|NCT04763499|Other|freeze dried strawberry powder|approximately 24 strawberries that have been freeze dried into a powder
15761637|NCT04763486|Drug|Cefazolin (Cefamezin)|Cefamezin 2 gr within 6 hour of delivery
15761638|NCT04763473|Dietary Supplement|Avocado extract|Participants will consume 10 grams of freeze dried avocado daily for 12 weeks.
15761639|NCT04763473|Dietary Supplement|Placebo|Participants will consume 10 grams of corn meal daily for 12 weeks.
15761640|NCT04763460|Device|Programming of CRT device settings|Reprogramming of CRT device to maximize the benefit derived from the electrocardiographic assessment.
15761734|NCT04762784|Drug|Tocilizumab|Tocilizumab treatment: Tocilizumab infusion 8mg/Kg，Once per month for 3 months.
15761642|NCT04763447|Drug|Continuation of OMA treatment|"Patients will be prescribed the same dosage of Omalizumab than they received before randomization, according to their weight and total circulating IgE levels.
~In case of safety concerns or loss of control, pulmonologist can modify the patient treatment regimen of OMA or other co-medications, as in usual care."
15761643|NCT04763434|Drug|dexamethasone; dexmedetomidine; ropivacaine|Ultrasound-guided multilevelTPVB is performed at the end of lobectomy
15761644|NCT04763421|Device|ENSEAL X1 Curved Jaw|ENSEAL X1 Curved Jaw is used for vessel transection according to instructions for use.
15761645|NCT04763408|Drug|Lenvatinib|Oral capsules.
15761646|NCT04763408|Drug|Sorafenib|Oral tablets.
15761647|NCT04763395|Other|No intervention|No intervention
15761648|NCT04763382|Other|experimental group: Training of caregivers|Pre-test, post-test, retention test, education, guide booklet delivery, android application installation and urinalysis
15761649|NCT04763382|Other|Control gruop|Pre-test, post-test and urinalysis
15761650|NCT04763369|Biological|Injection of stem cells in sub-tenon space of eye for the management of retinitis pigmentosa|Cultured stem cells will be injected in the sub-tenon space of eye and patients will be monitored and evaluated for outer retinal thickness, early treatment of diabetic retinopathy study visual acuity, visual field sensitivity, fundus photography, amplitudes of multifocal electroretinogram and implicit times of multifocal electroretinogram at baseline (day 0) and days 30, 60, 90, 180, 270 and 360.
15761651|NCT04763369|Biological|Injection of stem cells in suprachoroidal space of eye for the management of Retinitis Pigmentosa|Cultured stem cells will be injected in the suprachoroidal space of eye and patients will be monitored and evaluated for outer retinal thickness, early treatment of diabetic retinopathy study visual acuity, visual field sensitivity, fundus photography, amplitudes of multifocal electroretinogram and implicit times of multifocal electroretinogram at baseline (day 0) and days 30, 60, 90, 180, 270 and 360.
15761653|NCT04763343|Drug|Ketamine Hydrochloride|Ketamine hydrochloride will be given as an intravenous infusion using a standard regimen given in most studies conducted: 0.5 mg/kg over 40 minutes. Ketamine infusions will be given every other day until either the subject reports clinician rated Scale for Suicidal Ideation (SSI) score of<4, and >50% decrease from baseline, and clinical assessment of patient not being suicidal for three consecutive pre-infusion ratings, or a maximum of six infusions have been given over the course of 2 weeks, or they have been discharged from the inpatient unit.
15761654|NCT04763343|Drug|Saline|Subjects randomized to placebo will be administered a saline (0.9% sodium chloride) drip for 40 minutes. Saline placebo infusions will be given every other day until either the subject reports clinician rated Scale for Suicidal Ideation (SSI) score of<4, and >50% decrease from baseline, and clinical assessment of patient not being suicidal for three consecutive pre-infusion ratings, or a maximum of six infusions have been given over the course of 2 weeks, or they have been discharged from the inpatient unit.
15761655|NCT04763343|Behavioral|CAMS Therapy|CAMS weekly sessions will also be started immediately as an inpatient at the start of the study while receiving ketamine or saline. CAMS will be continued weekly after the patient is discharged and followed up as an outpatient. Weekly CAMS sessions will be terminated after the subject, as an outpatient, has a clinician rated Scale for Suicidal Ideation (SSI) score of<4, and >50% decrease from baseline, and clinical assessment of patient not being suicidal, for at least 3 consecutive sessions of CAMS.
15761658|NCT04763317|Genetic|Prostate cancer risk gene panel|A list of genes created by study experts, thought to increase the risk of prostate cancer from from review previous research, this list is regularly reviewed for accuracy
15761659|NCT04763304|Other|Gown personal protective equipment (PPE-G) suit|Placement of PPE-G under direct instructions (audio recording), fluorescent solution full-body spray, removal of PPE under direct instructions (audio recording) and assessment of self-contamination through ultraviolet light scanning. Active (wet wipe cleanse of any fluorescent traces visible under ultraviolet light scanning) and passive (15 minute interval) washout period to prevent a carry over effect on the second allocated intervention.
15761660|NCT04763304|Other|Coverall personal protective equipment (PPE-C) suit|Placement of PPE-C under direct instructions (audio recording), fluorescent solution full-body spray, removal of PPE under direct instructions (audio recording) and assessment of self-contamination through ultraviolet light scanning. Active (wet wipe cleanse of any fluorescent traces visible under ultraviolet light scanning) and passive (15 minute interval) washout period to prevent a carry over effect on the second allocated intervention.
15761661|NCT04763291|Dietary Supplement|Juice Plus+ Fruit, Vegetable and Berry blends|Encapsulated juice powder concentrate derived from 36 dried fruits, vegetables and berries.
15761662|NCT04763291|Dietary Supplement|Juice Plus+ Omega blend|Encapsulated plant-based fatty acid supplement.
15761663|NCT04763278|Device|Point Digit|The Point Digit partial hand prosthetic system consists of 1-4 ratcheting mechanical digits and a mounting bracket
15761664|NCT04763265|Biological|"Botulinum toxin A BoNT/A-DP"|To assess the efficacy of treatment with BoNT/A-DP in reducing the severity of glabellar frown lines at maximum frown.
15761665|NCT04763265|Biological|"Botulinum toxin A Botox Cosmetics"|To assess the efficacy of treatment with Botox Cosmetics in reducing the severity of glabellar frown lines at maximum frown.
15761666|NCT04763252|Other|Spectrum Therapeutics cannabis products|"For the purposes of this study, subjects enrolled will have been prescribed/authorized Spectrum Therapeutics (ST) products that are commercially available in participating countries. It is important to note that product availability varies from country to country. No country except Canada, has access to the full ST medical portfolio (e.g., only flowers are available in Germany). The full repertoire of Spectrum Therapeutics products are outlined on the website https://www.spectrumtherapeutics.com/canada/en/patients/products. It encompasses six colors (order from Red to Yellow follows the descending THC:CBD ratio), and five types of formulations: soft gels, spray, oil, flowers and vapes). Refer to webpage for the most up to date products available per country https://www.spectrumtherapeutics.com/canada/en/patients/products."
15761667|NCT04763226|Drug|BMS-986308|Specified dose on specified days
15761668|NCT04763226|Other|Placebo (for BMS-986308)|Specified dose on specified days
15761669|NCT04763226|Drug|Furosemide|Specified dose on specified days
15761670|NCT04763213|Diagnostic Test|Coronary Angiography|Patients diagnosed with occlusive or nonocclusive coronary artery disease who were treated invasive techniques (Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting)
15761671|NCT04763213|Diagnostic Test|Coronary Angiography|Patients diagnosed with oclusive or nonoclusive coronary artery disease who were treated medically
15761672|NCT04763200|Device|Impella CP® / Impella CP® with SmartAssist® / Impella 2.5®|Impella CP / Impella CP with SmartAssist will be used in most patients randomized to the Impella arm. Impella 2.5 may be used in patients with small body size (BMI <20 kg/m2 or body weight <60 kg) or if the iliofemoral vasculature is able to accommodate the smaller Impella 2.5 device but not the Impella CP device.
15761673|NCT04763200|Device|IABP Intra-aortic balloon pump|IABP uses counterpulsation to provide 0.2L/min coronary flow
15761674|NCT04763187|Procedure|Tooth extraction|Tooth extraction and alveolus regeneration with autologous blood concentrate.
15761675|NCT04763174|Behavioral|mHealth Coping Skills Training for Symptom Management (mCOPE)|mCOPE participants will complete 5 videoconferencing sessions (within 5-9 weeks) with a psychologist, each lasting 45-60 minutes, from a location convenient to the patient (e.g., home, work). Sessions will include cognitive behavioral coping skills designed to target pain, fatigue and psychological distress symptoms unique to colorectal cancer patients. mCOPE will include a mobile app for: 1) coping skills content (e.g., audio, video), 2) daily symptoms assessment and coping skills use tracking transmitting in real-time to study staff, and 4) push notifications for reminders, encouragement, and personalized feedback.
15761676|NCT04763161|Procedure|Decompressive hemicraniectomy|Decompressive hemicraniectomy in the context of a malignat sylvian ischaemic cerebral accident
15761677|NCT04763161|Procedure|neurosurgical operation|neurosurgical operation on which cranial, meningeal, vascular (branch of the middle meningeal artery) or cerebral bone tissue is not preserved during the surgical approach.
15761678|NCT04763135|Drug|Mirtazapine|"Orally disintegrating tablets of mirtazapine introduced at the dose of 15 mg and increased up to 45 mg per day during 56 days.
~Doses escalation: based on symptom management and side effect assessment."
15761679|NCT04763135|Drug|Escitalopram|"Orally disintegrating tablets of escitalopram introduced at the dose of 10 mg (or 5 mg for patients older than 65) and increased up to 20 mg per day during 56 days.
~Doses escalation: based on symptom management and side effect assessment."
15761680|NCT04763122|Other|not applicable as it is a retrospective study|It is a retrospective study
15761681|NCT04763109|Other|Whole-body Magnetic Resonance Imaging|Whole-body Magnetic Resonance Imaging at baseline, 1 month, and 12 months
15761682|NCT04763096|Drug|Advagraf|"Researchers must check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 5~10ng/ml of study treatment. Duration of treatment The investigational product will be administered for 24 weeks. (The lowest blood levels shall be adjusted at the discretion of the researchers, taking a blood sample is carried out in the morning before administrated of Investigational Product)
~Tacrolimus blood level is 3-10 ng/ml for 6 months prior to screening and during the maintenance therapy.
~( ① -1day to enrollment : swich to the day before ADVAGRAF®, ② 0day to enrollment : the day swich to ADVAGRAF® )
~Duration of treatment the investigational product will be administered for 24 weeks."
15761683|NCT04763083|Drug|NVG-111|Open label, continuous iv infusion, escalating doses of NVG-111 for minimum 3 cycles, 21 days on, 7 days off
15761684|NCT04763083|Drug|NVG-111 (RP2D)|Open label, continuous iv infusion at RP2D
15761685|NCT04763070|Drug|Ciprofloxacin Oral Product|The first stool sample will be taken before treatment and the second one will be taken in day 5 to 7 after treatment initiation. Treatment includes ciprofloxacin tablet 500mg twice a day for 5 days.
15761686|NCT04763057|Drug|NeoPUTTY MTA|NeoPUTTY, a premixed bioactive bioceramic MTA that triggers hydroxyapatite and supports healing
15761687|NCT04763057|Drug|calcium hydroxide|Calcium hydroxide the gold standard for IPT
15761688|NCT04763044|Drug|0 ppm F|Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
15761689|NCT04763044|Drug|250 ppm F as MFP|Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
15761690|NCT04763044|Drug|1100 ppm as MFP|Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
15761691|NCT04763044|Drug|2800 ppm F as MFP|Each subject will be randomly assigned to this treatment during one of the four periods for this crossover study.
15761692|NCT04763044|Drug|1100 ppm SnF2|Each subject will be assigned to this treatment during the fifth period for this crossover study.
15761693|NCT04763031|Radiation|Intra-operative Radiation Therapy - IORT|Single dose of 20 Gy
15761694|NCT04763018|Device|iTEAR100|Neurostimulation external nasal nerve to stimulate tear production
15761735|NCT04762784|Drug|Glucocorticoids|Prednisone/prednisolone: started at 0.6-0. 8mg/kg.d for 2 to 4 weeks, tapered at 5mg per 1-2 weeks to equal to or less than 15mg per day in 3 months.
15761964|NCT04760925|Device|CascadeTM, Non-Occlusive Remodeling Net|Temporary assistance device for coil embolization of intracranial aneurysms
15761695|NCT04763005|Behavioral|HIIT exercise intervention|The exercise intervention will be eight weeks of high-intensity interval training (HIIT) started by one warm-up week with an intensity of 75% maximum heart rate (HRmax). In the following seven weeks, the participants will perform a HIIT based on the following protocol and with a total duration of 45 minutes per session: warm-up for 10 minutes at 60-70% HRmax followed by a high-intensity interval consisting of 4x4 minutes at 80-90% HRmax with 3 minutes of active recovery at 60-70% HRmax and a 10 minutes cool-down at 60-70% HRmax. HR will be monitored during training by Polar® H7 heart rate sensors combined with Polar® M400 watches.
15761696|NCT04763005|Behavioral|Physical activity recommendations|The control group will get physical activity recommendations based on actual guidelines from the European Association of Preventive Cardiology.
15761697|NCT04762992|Drug|subcutaneous Enoxaparin|Enoxaparin subcutaneous injections (40 mg, 4000 IU daily) starting immediately after the diagnosis of FGR, and until 36 weeks of gestation or 12 hours before delivery, whichever comes first.
15761698|NCT04762992|Other|standard of care|Obsteric standard of care.
15761702|NCT04762966|Drug|Metformin|Level of Metformin blood concentration
15761703|NCT04762953|Drug|Paclitaxel|Intraperitoneal Paclitaxel
15761704|NCT04762953|Drug|Paclitaxel|IV Paclitaxel
15761705|NCT04762953|Drug|Leucovorin|IV Leucovorin
15761706|NCT04762953|Drug|Fluorouracil|IV 5-FU
15761707|NCT04762940|Device|Robotic|"The Amadeo® Manual Robotic System (Tyromotion GmbH, Graz, Austria) is designed for rehabilitative treatment of the hand and fingers providing robot-assisted exercise for the finger flexors and extensors. This system has a controlled position, active, active-assisted and passive exercise mode, it also allows isometric exercises with visual feedback provided during computerized games that emphasize flexion and extension.
~Robotic treatment will be conducted three times a week with 24 sessions (a month and a half of treatment) with assisted therapy: It allows to carry out the movement by force of the fingers themselves, compensating the range of movement that the user does not perform; and interactive therapy: it allows to carry out active finger movement oriented to tasks or games. These can be configured to adapt them as much as possible to the capabilities of the user."
15761708|NCT04762940|Device|Vibration|Vibration duration of approximately 20 minutes with a high vibration frequency will be conducted prior to robotic treatment. The intensity and timing of this treatment has been based on previous protocols, as previously justified in this project. Vibration therapy, with proprioceptive stimuli through sensors placed on the distal phalanges of the fingers, modulation from lower to higher frequency being possible (high frequency vibration of 300 Hz).
15761709|NCT04762914|Other|Prehabilitation|Prehabilitation is a multimodal and multidisciplinary person-centred perioperative approach involving supervised exercise training, nutritional education, management of polypharmacy and psychological advice.
15761710|NCT04762901|Drug|Niraparib|Oral tablet
15761711|NCT04762901|Drug|Doxorubicin|IV
15761712|NCT04762901|Drug|Cyclophosphamide|IV
15761713|NCT04762901|Drug|Paclitaxel|IV
15761714|NCT04762901|Drug|Pegfilgrastim|Injection
15761715|NCT04762901|Drug|Carboplatin|IV
15761716|NCT04762888|Procedure|Computed Tomography|Undergo PET/CT
15761717|NCT04762888|Drug|Gallium Ga 68 Gozetotide|Given IV
15761718|NCT04762888|Procedure|Magnetic Resonance Imaging|Undergo PET/MRI
15761719|NCT04762888|Procedure|Positron Emission Tomography|PET/MRI or PET/CT
15761720|NCT04762875|Biological|MGTA-145|MGTA-145 will be be administered as an IV infusion
15761721|NCT04762875|Biological|Plerixafor|240 µg/kg subcutaneously
15761722|NCT04762849|Procedure|Laparoscopic one anastomosis gastric bypass|Laparoscopic one anastomosis gastric bypass include the creation of gastric pouch; a jejunal loop measure about 200 cm from the ligament of Treitz and anastomosed to the gastric pouch. For the creation of a gastric pouch and gastroenterostomy use a linear stapler.
15761723|NCT04762849|Device|A shape-memory ring for adjustable gastric banding|A shape-memory ring (SMR) use for adjustable gastric banding. SMR is placed around the gastric pouch above the gastro-entero-anastomosis.
15761724|NCT04762836|Drug|D-cycloserine|Antibiotic medication that augments the function of NMDA-receptors
15761725|NCT04762836|Behavioral|Conditioning|During nocebo acquisition trials, the conditioned stimulus (i.e., activation of a sham electrode that can increase pain sensitivity, is paired to unconditioned high-pain stimuli (nocebo trials). During control trials of the acquisition phase, moderate-pain stimuli are paired to no sham electrode activation.
15761726|NCT04762836|Behavioral|Extinction|During nocebo extinction, moderate pain stimulations are administered both after the administration of the conditioned stimulus (i.e., activation of the sham electrode) and the control stimulus (no activation of the sham electrode), in order to evoke nocebo responses to the sham hyperalgesic procedure.
15761727|NCT04762836|Other|fMRI|In both arms of the study, BOLD response data will be collected with fMRI during the acquisition and extinction of nocebo effects on pain.
15761728|NCT04762836|Drug|Placebo|Placebo control in oral form
15761729|NCT04762823|Device|Cerebellar transcranial direct current stimulation at 4 mA|Uses weak electrical current (4 mA intensity) to either increase or decrease brain excitability and improve functional or cognitive outcomes.
15761730|NCT04762823|Device|Sham cerebellar transcranial direct current stimulation|Uses weak electrical current (4 mA intensity) at the beginning and the end of a given stimulation period to control for potential placebo effects or participant expectation bias.
15761731|NCT04762810|Drug|Cyclophosphamide and glucocorticoids|Prednisone/prednisolone: started at 0.6-0. 8mg/kg.d for 2 to 4 weeks, tapered at 5mg per 1-2 weeks before 15mg per day, and tapered at 2.5-5mg per 2 weeks to equal to or less than 5mg per day in 6 months. Cyclophosphamide 50mg per day for 6 months and decrease to 50mg Qod for 6 months.
15761732|NCT04762810|Drug|Glucocorticoids|Steroids have fast onset of action and multiple anti-inflammatory effects. Prednisone/prednisolone: started at 0.6-0. 8mg/kg.d for 2 to 4 weeks, tapered at 5mg per 1-2 weeks before 15mg per day, and tapered at 2.5-5mg per 2 weeks to equal to or less than 5mg per day in 6 months.
15761733|NCT04762797|Other|Non|This is a retrospective study, without intervention.
15761736|NCT04762771|Drug|Colchicine|"Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of CKD stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (AST/ALT > 3x normal).
~Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral"
15761739|NCT04762745|Drug|Pomalidomide|Pomalidomide( Anyue®, Chia Tai TIANQING, China), 4mg, orally(PO), d1-21, 28d/cycle, 1cycle.
15761740|NCT04762745|Drug|Bendamustine|Bendamustine( Leweixin®, Chia Tai TIANQING, China), 60mg/m2/d, intravenously(IV), d1-2, 28d/cycle, 1 cycle.
15761741|NCT04762745|Drug|Dexamethasone|Dexamethasone, 40mg, PO or IV, d1, 8, 15, 22, 28d/cycle, 1 cycle.
15761742|NCT04762745|Drug|Pomalidomide|Pomalidomide( Anyue®, Chia Tai TIANQING, China), 4mg, orally(PO), d1-21, 28d/cycle, 1cycle.
15761743|NCT04762745|Drug|Bendamustine|Bendamustine( Leweixin®, Chia Tai TIANQING, China), 70mg/m2/d, intravenously(IV), d1-2, 28d/cycle, 1 cycle.
15761744|NCT04762745|Drug|Dexamethasone|Dexamethasone, 40mg, PO or IV, d1, 8, 15, 22, 28d/cycle, 1 cycle.
15761745|NCT04762745|Drug|Pomalidomide|Pomalidomide( Anyue®, Chia Tai TIANQING, China), 4mg, orally(PO), d1-21, 28d/cycle, 1cycle.
15761746|NCT04762745|Drug|Bendamustine|Bendamustine( Leweixin®, Chia Tai TIANQING, China), 70mg/m2/d, intravenously(IV), d1-2, 28d/cycle, 1 cycle.
15761747|NCT04762745|Drug|Dexamethasone|Dexamethasone, 40mg, PO or IV, d1, 8, 15, 22, 28d/cycle, 1 cycle.
15761748|NCT04762745|Drug|Pomalidomide|Pomalidomide( Anyue®, Chia Tai TIANQING, China), 4mg, orally(PO), d1-21, 28d/cycle, 8 cycles. Then pomalidomide( Anyue®, Chia Tai TIANQING, China), 4mg, orally(PO), d1-21, 28d/cycle until progression or intolerable toxicities.
15761749|NCT04762745|Drug|Bendamustine|Bendamustine( Leweixin®, Chia Tai TIANQING, China), 70mg/m2/d, intravenously(IV), d1-2, 28d/cycle, 8 cycles.
15761750|NCT04762745|Drug|Dexamethasone|Dexamethasone, 40mg, PO or IV, d1, 8, 15, 22, 28d/cycle, 8 cycles. Then dexamethasone, 40mg, PO or IV, d1, 8, 15, 22, 28d/cycle until progression or intolerable toxicities.
15761751|NCT04762732|Device|NPWT|Wound of ALT donor site will be cared under PREVENA™ Incision Management System for 5 days post-operatively.
15761752|NCT04762732|Device|Traditional wound care|Wound of ALT donor site will be covered by vaseline gauze coated with tetracycline ointment (Genuine Chemical Pharmaceutical, Tao-Yuan, Taiwan), and layers of gauze.
15761753|NCT04762719|Drug|PET/CT Scan with 11C-ER176|An enrichment of markers associated with pro-inflammatory macrophages as well as loss of anti-inflammatory macrophages has been demonstrated in gastroparesis. There are currently no non-invasive ways of assessing immunopathology in the gastric muscle. Additionally, cellular changes can be patchy and untargeted full-thickness biopsies do not allow a comprehensive assessment of the gastric wall. Recently, there have been advancements in radioligands that can be used to determine activated macrophages. A novel, third-generation translocator protein (TSPO)-specific radioligand is ER176, which has shown high affinity and excellent in vivo target-to-background binding. Our preliminary data shows that TSPO is expressed in human gastric muscle macrophages. The overall goal of this proposal is to determine the utility of 11C-ER176 PET/CT imaging for assessing macrophage activation in vivo in gastric muscle of patients with diabetic gastroparesis.
15761754|NCT04762719|Diagnostic Test|Core biopsy of gastric muscle|We hypothesize that increased uptake of 11C-ER176 associates with a shift towards pro-inflammatory macrophage milieu on tissue assessment made by targeted biopsies of gastric muscle. EUS guided biopsies will be taken from the enhancing as well as non-enhancing (control) areas from the diabetic gastroparesis patients. Immune cell gene expression will be determined for pro- and anti-inflammatory gene markers
15761756|NCT04762693|Device|Hyfe cough tracker|A mobile app that runs in the background of smartphones and detects putative cough sounds.
15761757|NCT04762680|Biological|SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 1|Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection
15761758|NCT04762680|Biological|SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 2|Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection
15761759|NCT04762680|Biological|SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 3|Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection
15761760|NCT04762680|Biological|SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage A|Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection
15761761|NCT04762680|Biological|SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03, Dosage A|Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection
15761762|NCT04762680|Biological|SARS-CoV-2 adjuvanted recombinant protein vaccine, bivalent (D614+B.1.351)-AS03, Dosage A|Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection
15761763|NCT04762680|Biological|SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage B|Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection
15761764|NCT04762680|Biological|SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03, Dosage B|Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection
15761765|NCT04762680|Biological|SARS-CoV-2 adjuvanted recombinant protein vaccine, bivalent (D614+B.1.351)-AS03, Dosage B|Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection
15761965|NCT04760912|Drug|Rocuronium|Rocuronium used for neuromuscular blokade during anesthesia and anesthesia without rocuronium
15761766|NCT04762680|Biological|SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 1|Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection
15761767|NCT04762680|Biological|SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 2|Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection
15761768|NCT04762680|Biological|SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 3|Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection
15761769|NCT04762680|Biological|SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 4|Pharmaceutical form: Emulsion for injection. Route of administration: Intramuscular injection
15761770|NCT04762667|Procedure|reverse shoulder arthroplasty|"In our work, all patients are performs MSCT of the shoulder joint. The construction of a 3D model is carried out using the obtained data. Taking into account the individual features of the bone structure of the shoulder joint, images of the pilot wire guides, fixing screws and a resection template for the humerus are created. Holes for fixing spokes for the planned structures are also calculated.
~Using a 3D printer, models of guides and a resection template are printed. During the reverse shoulder arthropalsty, instead of a standard guide, patient-specific instrumentation are used.
~In the early postoperative period, all patients are performs MSCT of the shoulder joint. The obtained data are compared with the results of MSCT of the shoulder joints of patients previously operated on using the standard technique."
15761771|NCT04762654|Other|Modified Child Dental Anxiety Scale (MCDASf)|The MCDASf is self-reported dental anxiety measure effective among children aged 5-12 years.11 The scale has eight questions about 'going to the dentist generally,' 'having teeth examined,' 'teeth being scraped and polished,' 'injections in the gum,' 'fillings,' 'having a tooth taken out,' 'being put to sleep for treatment,' and 'having a mixture of gas and air that will help you feel comfortable for treatment but will not make you sleep.' The scores of each question ranged from 1 'relaxed' to 5 'very worried.' The scores are also represented by cartoon faces varied according to emotions and anxiety levels. The total scores can range from 8 to 40.
15761772|NCT04762641|Drug|ABL503|ABL503 will be administered intravenously (IV) on Day 1 and Day 15 of every 28-day cycle in the dose-escalation part. The dosing interval to be used in the dose-expansion part will be re-evaluated based on the emerging safety and PK data from the dose-escalation part of the study.
15761773|NCT04762628|Dietary Supplement|MAF capsules 148 mg|enteric capsules based on enzymatically treated bovine colostrum
15761774|NCT04762628|Dietary Supplement|M capsules 148 mg|enteric capsules based on enzymatically treated bovine whey
15761775|NCT04762628|Other|Standard of care|Standard of care
15761776|NCT04762615|Diagnostic Test|AMH level measurement|AMH level measurement using ELISA test from blood samples
15761777|NCT04762602|Drug|HMPL-306|Administered orally QD in a 28-day continuous dosing treatment cycle
15761778|NCT04762589|Drug|RT001|RT001 8.64 g/d (3 capsules TID) for 1 month followed by 5.76 g/d (3 capsules BID) for an additional 5 months
15761779|NCT04762589|Drug|Placebo|Placebo Comparator: Placebo Inactive comparator capsule 960 mg/capsule: 3 capsules TID for 4 weeks, followed by 3 capsules BID for the remaining 20 weeks.
15761780|NCT04762563|Other|IASTM application|IASTM application .
15761781|NCT04762563|Other|Kinesio Tape® Tex Gold)|Kinesio Tape® Tex Gold)
15761782|NCT04762537|Other|Standard Induction Procedure (SP)|SP includes stabilization on buprenorphine (6-8 mg) on Day 1 followed by a taper over the subsequent 4 days. After the completion of buprenorphine taper, participants will enter a washout period of at least 8 days. On the last day of the washout period, participants will be evaluated for eligibility to receive XR-NTX injection. Once found eligible, an XR-NTX injection will be given.
15761783|NCT04762537|Other|Rapid Induction Procedure (RP)|RP includes 1 day of buprenorphine 6-8 mg, followed by a day of washout and 4 days of oral naltrexone titration. If the participant is able to tolerate the last dose of the naltrexone titration, an XR-NTX injection will be given
15761784|NCT04762524|Other|CVVH vs CVVHD|Patients are initiated on CRRT in either the CVVH or CVVHD modality
15761785|NCT04762511|Biological|Lower dose formulation of HSV vaccine (GSK4108771A)|2 doses of the lower dose formulation of HSV vaccine (GSK4108771A) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 57.
15761786|NCT04762511|Biological|Low dose formulation of HSV vaccine (GSK4108771A)|2 doses of the low dose formulation of HSV vaccine (GSK4108771A) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 57.
15761787|NCT04762511|Biological|Medium dose formulation of HSV vaccine (GSK4108771A)|2 doses of the medium dose formulation of HSV vaccine (GSK4108771A) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 57.
15761788|NCT04762511|Biological|High dose formulation of HSV vaccine (GSK4108771A)|2 doses of the high dose formulation of the HSV vaccine (GSK4108771A) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 57.
15761789|NCT04762511|Drug|Placebo (saline)|2 doses of placebo (saline) administered intramuscularly in the non-dominant arm, one each at Day 1 and Day 57.
15761790|NCT04762498|Biological|Pegloticase and Methotrexate (MTX)|16 mg IV dose of pegloticase q4 weeks [with a potential for higher dose in cohort 2 (24 or 32 mg)], co-administered with 15 mg oral dose methotrexate weekly
15761791|NCT04762485|Biological|Humanized CD7 CAR-T cells|Split intravenous infusion of CD7 CAR-T cells [dose escalating infusion of (0.5-10)x10^6 CD7 CAR-T cells/kg
15761792|NCT04762472|Drug|Montelukast Oral Tablet|i) Montelukast 10mg daily (tablet) orally x 26 weeks
15761793|NCT04762472|Drug|Montelukast Placebo Oral Tablet|i) Placebo (Montelukast identical) tablet 1 daily orally x 26weeks
15761794|NCT04762459|Drug|Almonertinib|Almonertinib 110mg PO once daily
15761795|NCT04762459|Drug|Pemetrexed|500 milligrams per square meter (mg/m²) Pemetrexed
15761796|NCT04762459|Drug|Cisplatin|75mg/m² Cisplatin taken intravenously (IV) once every 3 weeks concurrently
15761827|NCT04762186|Drug|IMP RP2D plus SoC|"Intravenous administration adoptive SARS-CoV-2 specific T cells (IMP) at Recommended Phase II Dose (RP2D).
~The adoptive SARS-CoV-2 specific T cells are suspended and formulated in 50 ml of platelet additive solution and will be administered intravenously within 15 min to 30 min."
15761966|NCT04760912|Procedure|General anesthesia for surgery|General anesthesia with standard anesthetic monitoring,
15761797|NCT04762433|Device|Kegel Exercise Pregnancy Training - app|"KEPT-app is designed to educate pregnant women on PFMT via the step-by-step training with the capability element to improve their confidence and skills (beginner, intermediate and advance skills). Pregnant women are encouraged to continue adopt the PFMT throughout pregnancy until postpartum period.
~The details of the mHealth app content was developed based on the need assessment gathered from the cross-sectional study (Jaffar et al., 2020). It was conducted to identify the need of PFMT by looking at the prevalence of the UI among pregnant women and to understand their knowledge, attitude, and practices towards PFMT."
15761798|NCT04762420|Other|Dose of sugammadex according to SSD and QSD|At the time of pharmacologic reversal of the NMB, both the SSD and QSD, according to portuguese guidelines on the management of the NMB, were recorded. The QSD was then administered to the patient. The SSD was considered appropriate if it was within 10% of the recommended dose for the given depth of NMB, as measured by TOFscan® monitor. The results were analyzed descriptively.
15761799|NCT04762407|Drug|HGP1910|Take it once per period.
15761800|NCT04762407|Drug|HGP1909|Take it once per period.
15761801|NCT04762407|Drug|HCP1903|Take it once per period.
15761802|NCT04762394|Behavioral|The Child Behavior Checklist (CBCL),|It consists of 113 items; the parents complete it to detect emotional and behavioural problems in children and adolescents aged 6 to 18 years. It is scored on a three-point Likert scale (0=absent, 1= occurs sometimes, 2=occurs often). The time duration for item responses is the past six months.
15761803|NCT04762381|Drug|Dexamethasone phosphate|24 mg dexamethasone infused peroperatively
15761804|NCT04762381|Other|Placebo|Saline
15761805|NCT04762368|Device|Active anodal tDCS|a weak electric current is applied to the head through electrodes to affect the cortical excitability of the targeted cells in the brain.
15761806|NCT04762368|Device|Sham anodal tDCS|The tDCS machine will be used as in active stimulation, except the electrical current will not be applied.
15761807|NCT04762355|Drug|Palovarotene|ophthalmic solution in different concentrations: Dose 1, Dose 2 and Dose 3
15761808|NCT04762355|Drug|Vehicle|Placebo-to-match palovarotene ophthalmic solution vials
15761809|NCT04762342|Other|Resistance training (Power training)|"All sessions will start with a brief warm up on a stationary bike and uni-lateral knee raises.
~Power training: Involves exercises in which participants has to focus on performing fast/explosive muscle contraction during the concentric phase, and slow/controlled (approximately 2-3 s) muscle contraction during the eccentric phase.
~Functional- and balance exercises are included from week 10-24.
~Set, repetition, and load:
~Week 1-4: 3 sets of 15 repetitions at a load of 15 repetitions maximum (RM). Week 5-14: 3 sets of 12 repetitions at a load of 12 RM. Week 15-24: 3 sets of 10 repetitions at a load of 10 RM.
~Strengthening exercises:
~Bilateral leg press
~Bilateral plantar flexion (performed in leg press machine)
~Knee extension
~Dorsal flexion (Theraband gold resistance band (Theraband, Akron, OH, US))
~Seated crunches on exercise ball (Theraband gold resistance band (Theraband, Akron, OH, US)).
~Seated back extension lower back"
15761810|NCT04762329|Other|Manage My Pain (MMP) digital pain app group|To evaluate the extent of patient engagement with the Manage My Pain (MMP) digital application when used in a clinical setting
15761811|NCT04762316|Drug|PP6|"Dosage:
~-Take 1tablet/2 times/day/in throughout pregnancy."
15761812|NCT04762316|Device|PP6 Placebo|"Dosage:
~-Take 1tablet/2 times/day/in throughout pregnancy."
15761813|NCT04762303|Other|MedReviewRx|During the intervention phase, MedReviewRx will be made available to nursing homes with the understanding that it will be used to facilitate medication reviews and prescription check-ups. MedReviewRx provides clinicians with access to individualized and prioritized deprescribing information from MedSafer which: a) identifies potentially inappropriate medications (PIMs), b) explains why the medication is potentially inappropriate and c) provides instructions on how to safely stop/taper the medication.
15761814|NCT04762290|Other|Dance|The intervention is a series of expressive dance movements.
15761817|NCT04762264|Device|ProFlor inguinal hernia device|Device follow up after inguinal hernia repair with ProFlor
15761818|NCT04762251|Other|Time-restricted eating|Time restricted eating for a self-selected 9 hour window per day
15761819|NCT04762251|Other|Current Best Practice|Best practice guidelines to improve diet quality
15761820|NCT04762238|Other|Diacutaneous Fibrolysis|Diacutaneous Fibrolysis is a non invasive physiotherapeutic technique applied by means of a set of metallic hooks ending a spatula with bevelled edges that help to treat the muscles and conjunctive tissues and trying to improve mobility between mobility between muscle planes.
15761821|NCT04762225|Biological|RPTR-168|Escalating doses of RPTR-168 as a monotherapy
15761822|NCT04762212|Procedure|Mobilization with movement and stretching, stretching or control|The participants will receive a therapist performed mobilization with movement and then instructed in a stretching program to be followed for one week or only receive instruction in a stretching program to be followed for one week on the hip with the greatest limitation in motion. The hip with the least amount of limitation will not receive an intervention.
15761825|NCT04762186|Drug|IMP 1,000 plus SoC|"Intravenous administration of 1,000 adoptive SARS-CoV-2 specific T cells (IMP) per kg BW.
~The adoptive SARS-CoV-2 specific T cells are suspended and formulated in 50 ml of platelet additive solution and will be administered intravenously within 15 min to 30 min.
~All study patients at WHO Ordinal Scale ≥ 5 will receive the current SoC for treatment of COVID-19. Currently this is remdesivir (loading dose 200 mg i.v. on day 1, 100 mg maintenance dose day two to five (up to day 10)) - only WHO Ordinal Scale 5, dexamethasone 6 mg once daily p.o. or i.v. up to day 10 and a subcutaneous thromboembolism prophylaxis with low molecular-weight heparin."
15761826|NCT04762186|Drug|IMP 5,000 plus SoC|"Intravenous administration of 5,000 adoptive SARS-CoV-2 specific T cells (IMP) per kg BW.
~The adoptive SARS-CoV-2 specific T cells are suspended and formulated in 50 ml of platelet additive solution and will be administered intravenously within 15 min to 30 min.
~All study patients at WHO Ordinal Scale ≥ 5 will receive the current SoC for treatment of COVID-19. Currently this is remdesivir (loading dose 200 mg i.v. on day 1, 100 mg maintenance dose day two to five (up to day 10)) - only WHO Ordinal Scale 5, dexamethasone 6 mg once daily p.o. or i.v. up to day 10 and a subcutaneous thromboembolism prophylaxis with low molecular-weight heparin."
15762267|NCT04758767|Drug|CID-103|anti-CD38 antibody
15761828|NCT04762186|Drug|SoC|"Patients will receive the current SoC for treatment of COVID-19.
~Currently this is remdesivir (loading dose 200 mg i.v. on day 1, 100 mg maintenance dose day two to five (up to day 10)) - only WHO Ordinal Scale 5, dexamethasone 6 mg once daily p.o. or i.v. up to day 10 and a subcutaneous thromboembolism prophylaxis with low molecular-weight heparin."
15761829|NCT04762173|Device|Online self-help intervention|Access to two online, self-guided programs available on the SilverCloud Health website.
15761830|NCT04762160|Drug|Tazemetostat|Tazmetostat in combination with rituximab
15761831|NCT04762147|Drug|paracetamol, the group P|The paracetamol was administered 30 minutes before the start of surgery for intra-operative and post-operative analgesia in patients undergoing for hysteroscopy
15761832|NCT04762147|Drug|fentanyl, group-F administered as an active comparator|The fentanyl 2mcg/kg was administered at the time induction of anaesthesia for intra-operative and post-operative analgesia in patients undergoing for hysteroscopy
15761833|NCT04762134|Drug|Doxycycline Hyclate|STI PrEP arm: doxycycline capsules 100mg orally daily for 12 months STI PEP arm: doxycycline 200mg orally once within 24-72 hours following each sexual encounter deemed at risk (i.e. condomless anal or oral sex), to a maximum of six pills (i.e. 600 mg total) per week
15761834|NCT04762121|Procedure|Peripheral IV|Insertion of peripheral intravenous catheter
15761835|NCT04762108|Other|Standard of care|Patients will be given standard of care as per their clinical needs
15761836|NCT04762095|Other|mindfulness stress reduction program|mindfulness stress reduction program
15761837|NCT04762082|Drug|Tadalafil 10 MG|comparison of tadalafil gummy 10mg and tadalafil oral tablet 10mg
15761840|NCT04762056|Other|Chelsea Critical Care Physical Assessment Tool|Chelsea Critical Care Physical Assessment Tool is a bedside assessment tool firstly reported in 2013 to measure physical morbidity in the critical care population, consisting of 10 items (respiratory function, cough, moving within the bed, supine to sitting on the edge of bed, dynamic sitting, standing balance, sit to stand, transferring from bed to chair, stepping, and grip strength) rated on a 6-point scale from complete dependency (level=0) to independency (level=5). Therefore, the CPAx sum score ranges from 0 (worst condition) to 50 (best functioning/independence)
15761841|NCT04762043|Device|MyoVoice|Person-centric AAC system comprising a user-specific set of wearable sensors for capturing articulatory muscle activity and mobile software that provides real-time audible speech outputs.
15761842|NCT04762043|Device|Electrolarynx|Hand-operated electromechanical device that operates as an artificial larynx to enable a person after laryngectomy to produce speech.
15761843|NCT04762030|Drug|Durvalumab Anlotinib Carboplatin Nab-paclitaxel|"Neoadjuvant treatment (durvalumab+carboplatin+nab-paclitaxel + anlotinib) will start within 1-3 days from enrollment. 2 cycles will be administered at 21-day (+/- 3 days) intervals (QW3). Then, two cycles of combined durvalumab and anlotinib (QW3) will be administered prior to surgery. Before surgery, a tumor assessment will be done. Patients with stable disease or partial response may be considered for surgery.
~Surgery: Surgery must be done within the 5rd-7th week from day 1 cycle 4 of neoadjuvant treatment (day 35-49 after day 1 of cycle 4). Adjuvant treatment: Patients that are R0 confirmed by surgical pathology evaluation will receive the first adjuvant administration within the 2rd to 8th week from surgery. Twelve cycles of durvalumab adjuvant treatment (Q4W) will be administered."
15761844|NCT04762017|Drug|ACT-01 IV administration|Multiple Dose of ACT-01 IV administration for 5 consecutive days
15761845|NCT04762017|Other|Placebo IV administration|Placebo IV administration for 5 consecutive days
15761846|NCT04762004|Behavioral|Maternal speech|In both intervention conditions, speaking and singing, the mothers were asked not to touch the baby but to pay close attention to his/her reactions and to modulate the voice accordingly. A nurse was present during all procedures.
15761847|NCT04762004|Behavioral|Maternal singing|In both intervention conditions, speaking and singing, the mothers were asked not to touch the baby but to pay close attention to his/her reactions and to modulate the voice accordingly. A nurse was present during all procedures.
15761848|NCT04762004|Behavioral|Standard care|the newborn was placed by the nurse in the incubator in the standard care conditions recommended for painful procedures (supine position, wrapped and contained by the nest).
15761849|NCT04761991|Diagnostic Test|CMR and CTCA with CT-FFR|multi-parametric CMR assessment and CT coronary angiography with FFR assessment
15761850|NCT04761965|Diagnostic Test|Bone marrow cellularity by mDixon-quant|if trepanobiopsy was performed during the diagnosis, then comparison with MRI Bone marrow cellularity by mDixon-quant
15761851|NCT04761952|Drug|azathioprine|daily orally
15761852|NCT04761952|Drug|infliximab|intravenously, at 0, 2,6 weeks with every 8-week-interval later
15761853|NCT04761952|Drug|N-3 Polyunsaturated Fatty Acids|Ethyl polyenoate capsule is given as drug intervention. The main components are ethyl eicosapentaenoate (EPA-E) and ethyl docosahexaenoate (DHA-E), both of which will transform into ethyl eicosapentaenoate (EPA) and ethyl docosahexaenoate (DHA). Drug dose is 0.25 g EPA-E&DHA-E; per capsule one at a time, Three times a day.
15761854|NCT04761939|Combination Product|EluNIR Ridaforolimus Eluting Coronary Stent System|"The EluNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising of:
~Stent - a pre-mounted Cobalt Chromium (CoCr) alloy based stent - 2.25 mm Diameter and 8mm, 12mm, 15mm, 17mm, 20mm, 24mm, 28mm and 33mm length
~Delivery System - Rapid Exchange (RX) Coronary System
~Polymer matrix coating - Poly n-butyl methacrylate (PBMA) and CarboSil®
~Ridaforolimus drug - CAS Registry Number: 572924-54-0"
15761894|NCT04761562|Drug|Platelet- and extracellular vesicle-rich plasma|PVRP will initially be applied to the gelatine sponge without prior exogenous activation, which will first be inserted into the middle ear cavity to support the reconstructed tympanic membrane. The remainder of the PVRP will then be exogenously activated with calcium chloride. Gel rich with platelets and extracellular vesicles will be created and applied on top of the reconstructed tympanic membrane. Finally, the external auditory canal will be filled with pieces of gelatine sponge soaked with PVRP.
15762004|NCT04760665|Biological|Fecal microbiota transplantation|Patients will receive four fecal microbiota transplantation (FMT) capsules. Microbiota is obtained from healthy patients.
15761855|NCT04761926|Device|Audiometry|"Audiometry: Thresholds from the audiogram obtained when Ponto 4 were fitted. Pure tone air conduction (AC) and bone conduction (BC) audiometry conducted at the visit.
~Speech recognition in quiet: Speech intelligibility is measured in a soundproof room using the Matrix sentences presented from a loudspeaker. The Matrix test includes five-word sentences with a fixed syntactical structure and limited contextual cues. A list of 20 sentences is compiled from these words, ensuring that no sentence is repeated twice. This test will be obtained both unaided and aided (with and without the Ponto 4(s)).
~Sound field Audiometry: Detection of sound field thresholds presented from a loudspeaker. Thresholds will be obtained both unaided and aided and the test order will be balanced between subjects. During these measurements, the Ponto 4 will be programmed in omni-directional mode, with noise reduction and feedback management system turned off."
15761856|NCT04761900|Diagnostic Test|the differences of MAFLD and MAFLD-simplified definitions were compared in predicting metabolic diseases|
15761857|NCT04761887|Drug|Cool Ropivacaine Block|Ropivacaine is cooled.
15761858|NCT04761887|Drug|Room Temp Ropivacaine Block|Room Temp Block
15761859|NCT04761874|Other|Telestroke|In the telestroke cohort, acute ischemic stroke patients at a single comprehensive stroke center received their stroke care and management exclusively via telestroke.
15761862|NCT04761848|Drug|Cilostazol 50 MG|Cilostazol 50 MG tablet twice daily
15761863|NCT04761848|Drug|Placebo|Placebo tablet twice daily
15761864|NCT04761835|Biological|Peanut powder or peanut butter|Commercially available peanut powder or peanut butter.
15761865|NCT04761822|Biological|Moderna COVID-19 Vaccine|Intramuscular injection
15761866|NCT04761822|Biological|Pfizer-BioNTech COVID-19 Vaccine|Intramuscular injection
15761867|NCT04761822|Biological|Placebo|Intramuscular injection
15761868|NCT04761796|Other|Sleeping condition self-questionnaire|Professional flight members will answer a self questionnaire related to their sleeping conditions
15761869|NCT04761770|Other|Geriatric assessment (GA) pre-transplant|Assessment of comorbidities, polypharmacy, and functional, nutritional, and psychosocial impairment.
15761870|NCT04761770|Drug|conditioning regimen|"Based on the Geriatric assessment.
~HCT-CI/Age ≤4 AND no IADL impairment (less vulnerable/fit) -> Myeloablative (MA) regimen
~HCT-CI/Age >4 AND/OR any IADL impairment (more vulnerable) -> Reduced-intensity (RIC)/Nonmyeloablative (NMA) regimen"
15761871|NCT04761770|Procedure|Allogeneic CD34+ selected stem cells|Stem cells are collected as per institutional guidelines. CD34+ enriched stem cells will be obtained using the FDA approved reagents from Miltenyi, according to the instruction manual.
15761872|NCT04761757|Other|Booklet of Scripts of Doctors|"The Booklet of Scripts for Doctors was used in the control arm. This tool was developed and tested to encourage shared decision-making in prescribing antidepressants within the Malaysian context."
15761873|NCT04761757|Other|Booklet of Scripts for Doctors and the Antidepressant Decision Aid for Major depressive disorder patients (ADAM)|"The Booklet of Scripts for Doctors along with the Antidepressant Decision Aid for Major depressive disorder patients, ADAM, was used in the intervention arm. The decision aid was developed as per the International Patient Decision Aid Standards (IPDAS) criteria to enhance patient understanding of risks and benefits of different antidepressants available within the Malaysian context."
15761874|NCT04761744|Drug|Nivolumab|Study treatment consists of nivolumab 3mg/kg, and will be repeated every 2 weeks.
15761875|NCT04761731|Drug|ADVAGRAF®|"Administration method The total daily dose of tacrolimus will be converted to 1:1 (mg:mg) and the total daily dose of ADVAGRAF® will be administered only once daily in the morning, starting from Day 1 (at least one hour before breakfast or 2 to 3 hours after breakfast).
~Dose adjustment after conversion On Day 1, the total dose will be converted to 1:1. It is recommended to check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 5~8ng/ml for 0 to 3 months and then at 5ng/ml or below for 3 to 6 months of study treatment.
~Duration of treatment The investigational product will be administered for 24 weeks."
15761876|NCT04761705|Drug|JV-GL1|Experimental Treatment
15761877|NCT04761705|Drug|Latanoprost 0.005% Ophthalmic Solution|Active Control
15761878|NCT04761692|Behavioral|Full VEPMP Intervention|Delivery of intrapersonal/interpersonal (i.e., motivational interviewing, vaccine educators, personal testimony, etc.), AND organizational (i.e., church-based sponsored events, seminars, web/online activities, bulletin inserts, etc.)
15761879|NCT04761692|Behavioral|Partial VEPMP Intervention|Delivery of iAND organizational (i.e., church-based sponsored events, seminars, web/online activities, bulletin inserts, etc.)
15761880|NCT04761692|Behavioral|Delayed VEPMP Intervention|Delayed implementation of delivery of intrapersonal/interpersonal AND organizational after 1 year of study start
15761881|NCT04761679|Behavioral|Applying the Mepilex foam|Mepilex foam will be directly applied on the nasal bridge directly between the skin and the N95 mask.
15761884|NCT04761614|Biological|Bevacizumab|Given IVPB
15761885|NCT04761614|Drug|Fluorouracil|Given IV
15761886|NCT04761614|Drug|Leucovorin Calcium|Given IVPB
15761887|NCT04761614|Drug|Oxaliplatin|Given IVPB
15761888|NCT04761614|Drug|Riluzole|Given PO
15761889|NCT04761601|Drug|UCT-01-097|Orally available kinase inhibitor
15761890|NCT04761601|Drug|Gemcitabine|Gemcitabine injection for intravenous use.
15761891|NCT04761601|Drug|Paclitaxel|Paclitaxel protein-bound particles for injectable suspension (albumin-bound).
15761892|NCT04761588|Dietary Supplement|Tyr sphere|"Tyr sphere is a powdered, low phenylalanine and tyrosine protein substitute, containing a balanced mix of casein glycomacropeptide (cGMP) isolate, essential and non-essential amino acids, carbohydrate, fat, vitamins, minerals and the long chain polyunsaturated fatty acid (LCP) and docosahexaenoic acid (DHA). It contains sugars and sweetener.
~The product is designed to be prescribed based on its protein content, not its energy content."
15761893|NCT04761575|Other|Validation of the FFQ65+ via eNutri app|All participants will provide two eNutri FFQ datasets within a 14-day interval along with three 24-hour dietary recalls and dried blood spot samples.
15761895|NCT04761562|Procedure|Control group|Edges of the tympanic membrane perforation will be refreshed and the tympanomeatal flap raised. Under the tympanic membrane perforation, a guide (fascia of the temporalis muscle, perichondrium, cartilage or fat) will be placed. An absorbent gelatin sponge will be placed under the guide and on the outer surface of the reconstructed tympanic membrane.
15761896|NCT04761549|Other|Adolescent Idiopathic Scoliosis|Adolescent Idiopathic Scoliosis
15761897|NCT04761536|Other|Rectal cancer case centralization|In November 2016, the decision to centralize rectal cancer patients to only one surgical unit was taken, with only two surgeons performing the procedures. Furthermore, a close collaboration with local Gastroenterology Units and General Practiotioners was started in order to increase colorectal cancer case referral to our unit. At the same time, we decided to promote the use of laparoscopy and to implement ERAS protocol in our colorectal surgery practice.
15761898|NCT04761523|Behavioral|Dietary intervention: reduced fat diet|Participants will receive a dietary intervention, and will be proposed to adhere to a diet with a 15% fat, 65% carbohydrate, 20% protein content.
15761899|NCT04761523|Behavioral|Dietary intervention: standard healthy diet|Participants will receive a dietary intervention, and will be proposed to adhere to a diet with a 30% fat, 50% carbohydrate, 20% protein content.
15761900|NCT04761510|Behavioral|Mindfulness-SOS for Refugees|Mindfulness-SOS for Refugees is a brief internet-based mobile-supported intervention program which is a mobile-health adaptation of MBTR-R - a mindfulness- and compassion-based, trauma-sensitive, and socio-culturally adapted group intervention program designed for FDPs. Mindfulness-SOS for Refugees entails 8 brief sessions and 9 mindfulness meditation practice exercises - delivered via audio recordings using participants' smartphones. The intervention program is specifically designed to mitigate acute stress and related mental health symptoms among FDPs. During participation in the Mindfulness-SOS for Refugees intervention program, participants will be encouraged to complete 2 sessions per week and practice each day for 4 weeks but can choose to extend this up to 8 weeks. Delivery of Mindfulness-SOS for Refugees entails administrative guidance as well as adherence-focused guidance.
15761901|NCT04761497|Other|Actice music therapy|active music therapy sessions for three months
15761902|NCT04761497|Other|Watching nature videos|nature videos sessions for three months
15761903|NCT04761497|Other|Passive music therapy|passive music therapy for three months
15761904|NCT04761484|Procedure|Vascular access on admission|PIVC insertion
15761905|NCT04761471|Device|TI transcranial electrical stimulation|"Participants will undergo transcranial electrical stimulation, which will be delivered with low current amplitudes (<= 2 mA) established with international safety guidelines for electrical stimulation. Threshold for the current amplitude will be established by participants themselves, such that they cannot distinguish when stimulation is applied and not applied.
~Duration of stimulation will not last longer than 30 minutes."
15761906|NCT04761458|Diagnostic Test|Olfactory function testing|Olfactory function will be evaluated through the Burghart Sniffin' Sticks test which is a validated psychophysical testing method. Sniffin' Sticks test is based on pen-like odor dispensing devices that will be presented to the patients. The extended version of this test will be used and consist of three tests of olfactory function, namely tests for odor threshold, odor discrimination and odor identification.
15761907|NCT04761458|Diagnostic Test|Edmonton Frail Scale|The Edmonton Frail Scale (EFS) involves nine domains of frailty : functional performance, cognitive function, general health, functional independence, social support, used medications, nutrition, mood and continence. It has been validated with respect to comprehensive geriatric assessment and to other screening tools related to frail state. EFS test is considered most appropriate for use in routine preoperative screening and only requires 5 minutes.
15761908|NCT04761458|Diagnostic Test|Clinical Frailty Scale|The Clinical Frailty Scale (CFS) uses clinicians' judgement to evaluate frailty. It comprises assessment of specific domains including comorbidity, function, and cognition. Score ranges from 1 (very fit) to 9 (terminally ill).
15761909|NCT04761458|Diagnostic Test|Neuropsychological test battery|Patients will undergo a neuropsychological test battery preoperatively and postoperatively. This test consists of a battery of psychometric assessments with the ability to objectively assess specific cognitive domains such as attention, executive function, learning and memory, language, perceptual-motor, or social cognition.
15761910|NCT04761445|Other|Straumann Standard Plus implant and JDental care (JD) Octa implant|Two different implant systems were used. The above-mentioned implants share many features in common, such as implant design. They both have a machined implant collar of 1.8 mm.
15761911|NCT04761432|Device|neoGuard|NeoGuard is a wireless wearable vital signs monitor that continuously measures temperature, pulse rate, respiratory rate and oxygen saturation.
15761912|NCT04761419|Behavioral|Parents' longer presence beside their infant|They are not intervention. We will collect data about these items.
15761913|NCT04761406|Dietary Supplement|Phaeosol group|"In a double blind, randomized manner, 40 pre-menopausal females will ingest one of the following for 12 weeks:
~Treatment 1 -Placebo (218 mg/d of 100% sunflower Oil) Treatment 2 - PhaeoSOL (218 mg/d)
~Supplements will be prepared in softgel capsules for double blind administration by the sponsor."
15761914|NCT04761406|Dietary Supplement|Placebo group|"In a double blind, randomized manner, 40 pre-menopausal females will ingest one of the following for 12 weeks:
~Treatment 1 -Placebo (218 mg/d of 100% sunflower Oil) Treatment 2 - PhaeoSOL (218 mg/d)
~Supplements will be prepared in softgel capsules for double blind administration by the sponsor."
15761915|NCT04761393|Procedure|Hyperpolarized 129Xe (Xenon) diffusion-weighted MRI|Participants will inhale a one litre gas mixture containing hyperpolarized 129Xe mixed with nitrogen (N2) or helium (4He) from a one litre dose bag. Breath-hold will be up to 16 seconds
15761916|NCT04761380|Diagnostic Test|balloon-based tongue pressure measurement device|The probe was inflated at a baseline pressure of 19.6 kilopascal (kPa). To measure MTP, the balloon was positioned on the anterior palate with the lips closed. Subjects raised their tongue and compressed the balloon onto the palate with maximal voluntary muscular effort for approximately 7s. The measurement was taken three times with a 1-min interval. The maximum value was recorded as the MTP.
15761917|NCT04761367|Other|Physical activity. Physical Activity program is performed in a group in a gym|The intervention groups will be trained in a gyms under the direct supervision of a graduate trainer. All subjects will be requested to choose an additional third day of the week to carry out at least one of the following activities: walking, cycling or swimming
15761918|NCT04761354|Procedure|Unilateral adrenalectomy|
15761920|NCT04761328|Behavioral|cognitive behavioral therapy|Cognitive-behavioral therapy involves changing these erroneous cognitions and beliefs through cognitive restructuring, modification of behavior, and development of alternative coping skills.
15761921|NCT04761302|Other|Use of non-steroid anti-inflammatory drugs (NSAIDS) as an alternative for post-operative pain management after a femur and tibia fracture|This is a prospective, single blind, parallel groups, opioid control trial of all patients (total of 150 patients) who suffered tibial and femoral shaft fractures and were treated with intramedullary nailing. Patients will be aleatory assigned to two study groups: Group-1 will receive non-opioid medications, and Group-2 will receive opioid medications. During the inpatient postoperative period, patients will undergo subjective evaluation of pain utilizing a previously validated questionnaire, the Visual Analogue Score (VAS). The first questionnaire will be completed twelve hours after surgery and during subsequent twelve-hour intervals until discharge. Secondary outcomes will include efficiency such as time to gastrointestinal motility, time to weight bearing of affected limb, resumption of ambulation, and length of hospital stay. The evaluation will take approximately 15 minutes to complete each time, we the entire participation time to be 60 minutes.
15761922|NCT04761289|Other|Multimodal Exercise and Functional Rehabilitation Program|"Prescription of multimodal physical exercise.
~Reeducation of Activities of Daily Living (ADL).
~Prescription of support products and adaptations of the environment."
15761923|NCT04761276|Device|Surgical implantation of intra ocular lens|Cataract surgery may be indicated when the cataract reduces visual function to a level that interferes with everyday activities of the patient leading the patient to desire a surgical intervention to improve its vision.
15761924|NCT04761263|Other|Task-oriented circuit training|The task-oriented circuit training program consisted of 14 workstations. Time spent at each station will be 1.5 minutes. The children will complete the activity at one station and move to another station. The whole circuit will be completed in 21 minutes and it will be repeated twice per session with 3 minutes rest interval between the 2 circuits. Children will be encouraged to work as hard as possible at each workstation and will also be given verbal feedback and instructions aimed at improving performance. The progression of the task will be considered according to each child's ability and progressed as tolerated. Progressions include increasing the number of repetitions and increasing complexity of the exercise performed at each workstation, such as the distance reached in standing, reducing the height of the chair during sit-to stand, changing the height of blocks or by increasing speed of movement.
15761925|NCT04761263|Other|Selected Physical therapy program|"Facilitation of balance reactions from standing position including; standing on one leg, weight shifting from standing position, stoop and recover from standing, squat from standing and standing on balance board.
~Facilitation of counterpoising mechanism through instructing the child to kick ball from standing position as well as catching and throwing ball with his hands.
~Gait training activities including: walking using different obstacles (rolls, wedges, stepper) and walking up and down stairs.
~Facilitation of protective reaction from standing position by pushing the child in different directions.
~Facilitation of rising mechanism through changing position as well as returning back to the original position e.g.: from lying to standing and from sitting to standing.
~Strengthening exercises for back and abdominal muscles as well as upper and lower limbs.
~Jumping in place and jumping a board."
15761926|NCT04761250|Dietary Supplement|Lifestyle|Lifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation
15761927|NCT04761237|Drug|Goal-directed fluid therapy (GDET)|Compensatory dilatation was performed firstly and 5ml/kg crystal solution was added within 30min before induction of anesthesia.When SVV≥13%, infusion of colloidal solution 2ml/kg was performed 15-20 minutes.If the increase of SV was≥10% after the liquid impact and the SVV was still≥13%, the colloidal solution was used again for 2mL/kg and the infusion was maintained until the SVV < 13%.The infusion was stopped when the SVV < 10%.If the increase of SV was less than 10% or CI < 2.0L/min/m2 after infusion, dobutamine was given intravenously to observe the change of SV. If the increase of SV was greater than 10%, dobutamine could be maintained and the above fluid regimen continued.If the increase of SV was less than 10% and MAP≥65mmHg, the infusion of liquid was stopped and replaced with 4ml/kg/h infusion for maintenance.If the increase of SV was less than 10% and MAP was less than 65mmHg, the infusion was suspended.
15761928|NCT04761224|Device|Fluido® Irrigation Fluid Heater System|"Patients in the Heated group will benefit from intraoperative warming by means of NaCl bags instilled using the Fluido® Irrigation warming cassette and with the use of specific instillation tubing (SEBAC laboratory, Set URO Fluido® Irrigation): this device allows continuous and precise heating of the solution with an instillation temperature of 38-39°C."
15761930|NCT04761198|Drug|Etigilimab dosing|IV infusion of IV etigilimab every 2 weeks
15761931|NCT04761198|Drug|Nivolumab|IV infusion of nivolumab every 2 weeks
15761932|NCT04761185|Drug|Raltitrexed|Raltitrexed in HIPEC
15761933|NCT04761172|Procedure|Intraoperative near-infrared fluorescence imaging using indocyaninegreen|ICG administration before/during surgery and using near-infrared fluorescence imaging for intra-operative detection and identification of GISTs
15761934|NCT04761159|Drug|Ketamine|Different mixture of ketamin-propofol will apply for anesthesia induction.
15761935|NCT04761146|Radiation|DaRT Diffusing Alpha-emitters Radiation Therapy|DaRT is a brachytherapy treatment comprising stainless-steel 316LVM wires coated with radium-224 (Alpha DaRT seeds). The radioactive seeds are inserted directly into the tumour on the perineum and will be removed after 14 days.
15761936|NCT04761133|Drug|Povidone-Iodine pleural irrigation|Irrigation of the infected pleural cavity with an antiseptic solution to reduce microbial load
15761937|NCT04761120|Device|Abbott SJM Rigid Saddle Ring|The Abbott SJM Rigid Saddle Ring is a rigid, polyester-velour-covered, titanium alloy mitral annuloplasty ring with a saddle shape intended to mimic the shape of a healthy mitral annulus during systole.
15761938|NCT04761120|Device|Abbott SJM Séguin Ring|The Abbott SJM Séguin Ring is a semi-rigid, polyester-velour-covered, polyethylene mitral annuloplasty ring that varies in thickness and flexibility over its circumference, with the posterior portion of the ring having greater flexibility than the anterior portion.
15761939|NCT04761120|Device|Abbott SJM Tailor Ring|The Abbott SJM Tailor Ring is a flexible, polyester-velour-covered, silicone annuloplasty ring indicated for use in surgical repair of the mitral or tricuspid valve. The Tailor Ring can be implanted as a full annuloplasty ring, or the surgeon can remove the ring's cut zone with a scalpel and use the partial Tailor Ring as a posterior annuloplasty band.
15761940|NCT04761120|Device|Abbott SJM Tailor Band|The Abbott SJM Tailor Band is a flexible, polyester-velour-covered, silicone band for posterior annuloplasty indicated for use in surgical repair of mitral or tricuspid valve. The Tailor Band is identical to the Tailor Ring with the cut zone removed, save that the polyester covering is sewn closed at the ends of the band during manufacturing.
15761941|NCT04761094|Device|Insulin pump|Treatment with continuous subcutaneous insulin infusion
15761942|NCT04761081|Behavioral|Habitual physical activity assessment|7 days habitual physical activity via accelerometry (ActiGraph GT3x). Specifically steps per day, light physical activity (minutes per day), and moderate to vigorous physical activity (minutes per day).
15761943|NCT04761068|Device|VEST|Venous External Support for vein grafts in CABG
15761944|NCT04761055|Other|Clinical Breast exam (CBE)|The standard CBE will be performed by a nurse practitioner (NP) who will record any positive CBE finding.
15761945|NCT04761055|Device|iBreastExam device|The iBE is an FDA 510(k) cleared portable device which utilizes an array of dynamic capacitive pressure sensors to perform electronic palpation for breast abnormalities. The iBE exam will be administered by a mammogram technologist, blinded to CBE results.
15761946|NCT04761055|Diagnostic Test|mammogram|All patients will have routine standard mammographic views performed. Patients with positive iBE and/or CBE findings will have additional mammographic and/or ultrasound imaging to determine if a correlating breast lesion is present using the same standard of care algorithm as is used currently for positive CBE findings.
15761947|NCT04761042|Other|WAYA-Wilderness|"The wilderness intervention includes challenging tasks in order to help participants' overcome and master new physical and psychological challenges in an unknown environment, with the idea to support self-efficacy, self-esteem, and ability to recover from adversity. The program is designed to encourage participants to connect with nature as to experience gratitude for the richness of the natural world, a sense of calmness and trust upon spending time in nature, and to be more physically active in nature.
~Elements previously described Participants will continue in a three-month program at home (on-line supported) after the initial 8-days in order to empower participants to incorporate elements of the onsite wilderness program into their daily life. An individualized a plan for activities will be developed together with the participant.
~After three months, there will be a re-visit with follow up on outcome measures and reconnection."
15761948|NCT04761042|Other|WAYA-Holiday|"An attention control group (information in Detailed description)"
15761949|NCT04761029|Other|RIIS|unilateral Rhomboid intercostal and subserratus block
15761950|NCT04761029|Drug|Tramadol|intravenous patient-controlled analgesia (tramadol)
15761951|NCT04761016|Other|Usual Care|The current I-POP health model includes: 1) BSW HWC primary care medical home (for uninsured or Medicare patients), 2)BSW HWC providing diabetes prevention, nutrition education, weight loss, farm stands, physical activity programming (in collaboration with its onsite City of Dallas Park and Recreation Center), 3) BSW HWC programming at community sites in 75210, 4) Referrals to Parkland Hatcher Station clinic that provides health care to Medicaid patients, 5) Referrals between Parkland Hatcher Station and BSW HWC programming, 6) Community improvement in collaboration with Frazier Revitalization Inc. Individuals will have access to resources within our current, ongoing I-POP Health model, but without CHW navigation between BSW HWC and local service providers. Participants will complete follow-up visits for collection of study measures with study personnel at 6- and 10- months. At the end of the 10-month follow-up period, participants receive an assigned CHW and CHW-navigation.
15761952|NCT04761016|Other|I-POP + CHW navigation|Individuals randomized to this condition will be paired with a CHW to assist with navigation of I-POP Health resources at BSW HWC and entities in local zip codes. CHW navigation will occur through monthly one-on-one follow-up visits for a period of 10-months. Participants will complete study visits for collection of data measures at baseline, 6- and 10- month timepoints. Study participation ends with completion of 10-months data measures.
15761953|NCT04761003|Device|Thoracoscopy forceps|take pleural biopsy
15761954|NCT04760990|Other|data collection|clinical data collection regarding COVID-19 suggestive symptoms or confirmed SARS-CoV-2-infections (medical events), recorded comorbidities (concomitant diseases relevant to MS and COVID-19) and recorded vaccinations (other treatments). This information is systematically collected during the routine clinical visits of the patient within the SMSC every 6-12 months.
15761955|NCT04760990|Other|analysis of blood samples|analysis of archived serum samples collected every 6-12 months within the SMSC for measurement of anti-SARS-CoV-2 antibodies in pre-pandemic reference samples and prospectively determine the anti-SARS-CoV-2-serostatus during the study period.
15761956|NCT04760977|Drug|Drugs administration|Antifibrinolytics, analgesics, sedatives, neuromuscular blocking agents
15761957|NCT04760977|Device|Resuscitative endovascular balloon occlusion of the aorta|Resuscitative technique for exsanguinating traumas
15761958|NCT04760977|Biological|Blood transfusions|Transfuion of transported blood products for exsanguinating traumas
15761959|NCT04760977|Other|Prehospital management|Stay and play strategy vs scoop and run
15761960|NCT04760951|Dietary Supplement|TOTUM-070|5-g dose of TOTUM-070 diet supplement, a mix of 5 plant extracts. Eight capsules per day to consume orally in two intakes
15761961|NCT04760951|Dietary Supplement|Placebo|Placebo. Eight capsules per day to consume orally in two intakes
15761962|NCT04760938|Behavioral|Outdoor Behavioral Healthcare (OBH)|Participants in this intervention will participate in one of 7 programs that have been accredited by the Outdoor Behavioral Healthcare Council that specializes in 13-17 year old adolescents experiencing behavioral healthcare issues. Each program works in a unique wilderness setting in various United States National Forests and Parks (e.g., Washington, Oregon, New Mexico, Wisconsin, Utah). The average length of stay in an OBH wilderness program is 90 days, which is a total standard care time of 1,056 hours. All of the OBH programs have been accredited by the Association for Experiential Education Accreditation for Outdoor Behavioral Healthcare programs.
15761963|NCT04760938|Behavioral|Cognitive Behavioral Therapy (CBT)|The 12-week treatment period will consist of 15 90-minute sessions that will be administered individually. Homework (including reading assignments) are given to encourage your child to practice the techniques learned during the weekly sessions. The total standard of care time for CBT is 22.5 hours of direct treatment hours not including time spent on homework over these twelve weeks. Those therapists that are selected to deliver treatment for the CBT group will be certified by a nationally recognized CBT organization and licensed to work as a therapist in the state where they are providing treatment. Therapy will be delivered in an outpatient setting or through Telehealth.
15761967|NCT04760899|Device|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation is a form of non-invasive brain stimulation. It uses small electrodes to deliver small amounts of current to specific areas of the brain to either increase or decrease excitability.
15761968|NCT04760886|Other|Type of hospital (rural DGH vs Urban MTC)|In this small cohort study, the hospital in which the patients were treated was the intervention. One was in a rural area and was a district general, whereas one was in an urban enviroment and was a major trauma centre.
15761969|NCT04760873|Device|cryotherapy|cryotherapy is a freeze spray that will be applied to GAVE for bleeding
15761970|NCT04760860|Drug|Terazosin Hydrochloride|In this double blind, randomized, placebo controlled phase I clinical trial, subjects randomized into the Terazosin group will receive Terazosin hydrochloride treatment for 15 weeks. Participants will start at 1mg daily for the first 6 week, then the dosage will be increased to 5mg daily over 3 weeks, and continued for the last 6 weeks.
15761971|NCT04760860|Other|Placebo|In this double blind, randomized, placebo controlled phase I clinical trial, subjects randomized into the control group will receive placebo for 15 weeks.
15761972|NCT04760847|Other|Intermittent Fasting|These subjects will will then receive information regarding intermittent fasting, which would include fasting for a 16-hour period each day, followed by ingestion of an appropriate number of calories for the remaining part of the day. See attached IF Quick Facts for details provided to the patient.
15761973|NCT04760847|Other|No intermittent fasting|These subjects will undergo standard caloric dietary guidance. Patients in group B will also be given the above information, though not be asked to intermittently fast
15761974|NCT04760834|Other|Questionnaire|Complete a questionnaire to look for signs of concussion in the past. The questions also seek to collect data on participants' knowledge, concussion management and potential confounding factors
15761975|NCT04760821|Drug|Trimetazidine|Trimetazidine 35mg bid in patients with GFR above 60mL/min. Trimetazidine 35mg od in patients with GFR between 30 and 60mL/min.
15761976|NCT04760808|Diagnostic Test|Baseline Clinical Examination|Evaluations of Postural control; Subjective postural vertical; Subjective visual vertical; Verticality perception
15761977|NCT04760808|Radiation|Initial 3T MRI of the Brain and Spine|Non-injected CSF flow MRI
15761978|NCT04760808|Diagnostic Test|6-month Follow-up Clinical Examination|Evaluations of Postural control; Subjective postural vertical; Subjective visual vertical; Verticality perception
15761979|NCT04760808|Radiation|6-month Follow-up 3T MRI of the Brain and Spine|Non-injected CSF flow MRI
15761980|NCT04760795|Other|PTSD Check List (PCL) scale|PTSD Check List (PCL) scale will be realized to evaluated post-traumatic stress disorder.
15761981|NCT04760795|Other|Brief COPE scale|Brief COPE scale dispositional version will be realized to evaluated usual coping strategies. It was assessed during the teleconsultations and post containment.
15761982|NCT04760795|Other|GAD-7 (Generalized Anxiety Disorder) scale (during containment)|GAD 7 (Generalized Anxiety Disorder) scale will be realized to evaluated anxiety during containment. It was assessed during the teleconsultations.
15761983|NCT04760795|Other|Analog scale|Analog scale will be realized to evaluated anxiety during containment. It was assessed during the teleconsultations.
15761984|NCT04760795|Other|GAD-7 (Generalized Anxiety Disorder) scale (post containment)|GAD-7 (Generalized Anxiety Disorder) scale will be realized to evaluated anxiety during post containment.
15761985|NCT04760795|Other|Big Five Inventory (BFI) scale|Big Five Inventory (BFI) will be realized to evaluated personality.
15761986|NCT04760795|Other|Relationship Scales Questionnaire (RSQ)|Relationship Scales Questionnaire (RSQ) will be realized to evaluated attachment style.
15761987|NCT04760782|Drug|Abaloparatide|Abaloparatide 80 mcg by subcutaneous, self-administered injection once per day (8 weeks)
15761988|NCT04760782|Device|Hard collar immobilization|Hard collar immobilization of the cervical spine for 12 weeks
15761990|NCT04760756|Other|Fragility Fracture Integrated Rehabilitation Management|"At least 2 hours of rehabilitation management per day
~Including occupational therapy (training to improve daily life performance)
~Inpatient (the first 2 weeks): daily management (body control ability, mobility ability, hygiene management, etc.)
~Outpatient (2-6 weeks): management once a week
~The management period is for 2 weeks (1 week after surgery)"
15761991|NCT04760743|Biological|NBP2001 adjuvanted with alum (RBD 30μg/dose)|Participants will receive intramuscular (IM) injections of NBP2001(RBD 30μg/dose) on Days 0 and 28.
15761992|NCT04760743|Biological|NBP2001 adjuvanted with alum (RBD 50μg/dose)|Participants will receive intramuscular (IM) injections of NBP2001(RBD 50μg/dose) on Days 0 and 28.
15761993|NCT04760743|Other|Normal Saline|Participants will receive intramuscular (IM) injections of Normal saline on Days 0 and 28.
15761994|NCT04760730|Biological|AZD1222|"Active substance: ChAdOx1 nCoV-19, a replicant-deficient simian adenoviral vector in the amount of 5 х 10^10 particles (nominal) per dose (unit dose strength > 0.7 × 10^11 vp/mL).
~Solution for intramuscular injection, supplied in vials in a carton box"
15761995|NCT04760730|Biological|rAd26-S|"Component I (Dose 1) - (0.5 ml per dose) contains:
~Active substance: recombinant adenovirus serotype 26 particles containing the SARS-CoV-2 protein S gene, in the amount of (1.0±0.5) х 10^11 particles per dose (unit dose strength 1 × 10^11 vp/0.5 mL) .
~Solution for intramuscular injection, supplied in vials in containers"
15761996|NCT04760717|Drug|Spironolactone Pill|Participants randomized to the Spironolactone arm will be receiving Spironolactone in addition to their normal routine blood pressure treatment.
15761997|NCT04760704|Biological|Specific antibody and cellular immune response after anti-SARS-CoV-2 vaccine administration|Specific T cells and specific antibodies assessment
15761998|NCT04760691|Drug|Truvada alone|TDF/FTC 300 mg (milligrams) / 200 mg by mouth once daily
15761999|NCT04760691|Drug|Truvada plus Leuprolide|TDF/FTC 300mg/ 200 mg by mouth once daily Leuprolide 11.25 mg im once
15762000|NCT04760691|Drug|Truvada plus Estradiol 1 mg|TDF/FTC 300mg/ 200 mg by mouth once daily Estradiol 1 mg by mouth once daily
15762001|NCT04760691|Drug|Truvada plus Estradiol 6 mg|TDF/FTC 300mg/ 200 mg by mouth once daily Estradiol 3 mg by mouth twie daily
15762002|NCT04760691|Drug|Estradiol 6 mg alone|Estradiol 3 mg by mouth twice daily
15762003|NCT04760678|Other|Observational study|No intervention (observational study in human participants)
15762005|NCT04760665|Other|Placebo|Patients will receive four oral capsules containing placebo. These capsules will have the same shape, weight and colour as capsules containing FMT.
15762006|NCT04760652|Behavioral|Cognitive Behavioral Therapy CBT|CBT: In-person and computer-based components (Good Days Ahead) First 4 weeks of CBT are twice weekly; thereafter weekly CBT
15762007|NCT04760639|Diagnostic Test|Breath test|Participants provide a breath sample
15762008|NCT04760626|Drug|Insulin icodec|Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 52 weeks.
15762009|NCT04760626|Drug|Insulin Glargine 100U/mL|Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.
15762010|NCT04760626|Drug|Insulin Degludec|Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.
15762011|NCT04760626|Drug|Insulin Glargine 300U/mL|Participants will receive subcutaneous (s.c.) injections of insulin analogues once daily for 52 weeks.
15762012|NCT04760613|Drug|Cannabidiol|600 mg oral daily use (each capsule of active drug contains 50 mg of CBD)
15762013|NCT04760613|Drug|Placebo|identical capsules containing placebo (taken daily by mouth)
15762014|NCT04760587|Behavioral|smart devices in adolescent weight control|The study will apply mobile phone applications and smart watches to understand the relationship between weight control behaviors and weight control health outcome in adolescent.
15762015|NCT04760574|Diagnostic Test|Testosterone|Serum total testosterone and free testosterone level
15762016|NCT04760561|Procedure|prone position group|Patients randomized to this arm will receive self-prone positioning. Each patient in the intervention group will be helped into the prone position and encouraged to stay in the prone position as long as tolerated (at least 1 hour). The prone positioning consists of placing the patient on his or her stomach with the head on the side. Self-prone position will be performed 45 minutes up to 1 hour after meals to avoid gastrointestinal side effects. The patient will be maintained in prone position until the patient becomes too tired and uncomfortable to keep that position. If patients will asked to regain the supine position before the 1 hour period was complete, patient's prone position will be considered unfeasible and the reason will be reported. Patients who required invasive mechanical ventilation at any time point will be intubated and excluded from the study.
15762017|NCT04760548|Other|Observational study|
15762018|NCT04760535|Device|Invisalign® First Phase I treatment (Align Technology, Inc., Santa Clara, CA, USA)|Subjects in this arm will be instructed to wear aligners 24h/day for entire duration of the therapy. They will be asked to remove their retainers only while eating, drinking (except water), or cleaning.
15762019|NCT04760535|Device|Tooth-borne Hyrax-type maxillary expander|The expansion protocol will be one quarter-turn twice a week (0.45 mm activation per week) until overcorrection with the maxillary lingual cusps contacting the mandibular buccal cusps. The expander will be left passively for retention for a minimum of 6 months.
15762020|NCT04760522|Genetic|WGS Diagnostic: Blood take for genetic diagnostic|Blood sampling, short clinical characterization, WGS based sequencing, NGS analysis and other omics analysis (transcriptomics, proteomics, metabolomics).
15762021|NCT04760509|Other|In this study, the short-term follow-up of patients with neural tube defects in the neonatal intensive care unit will be evaluated retrospectively.|there is no intervention. It is retrospective study.
15762022|NCT04760496|Drug|Oxytocin 4 mIU/mL|Oxytocin at 4 mIU/mL administrated by IV infusion controlled by pump or electric syringe.
15762023|NCT04760496|Drug|Oxytocin 2 mIU/mL|Oxytocin at 2 mIU/mL administrated by IV infusion controlled by pump or electric syringe.
15762024|NCT04760483|Device|SoracteLite(TM) TPLA for BPH|see prior section
15762025|NCT04760470|Other|Technological-assisted upper extremity rehabilitation|Subjects get 6 weeks of technological-assisted upper extremity rehabilitation
15762026|NCT04760457|Procedure|Implant placement with flapped surgery|Four mini implants will be placed reflecting a flap.
15762027|NCT04760457|Procedure|Implant placement with flapless surgery|Four mini implants will be placed without reflecting a flap.
15762028|NCT04760457|Procedure|Implant immediate loading|Four mini implants will be immediately loaded.
15762029|NCT04760457|Procedure|Implant delayed loading|Four mini implants will be loaded after a 6-week healing period.
15762030|NCT04760444|Behavioral|Peer Leader Diabetes Self-Management Support|While the effectiveness of peer-led interventions delivering diabetes-related education and support for short-term clinical, psychosocial, and behavioral improvements is well-established, older Black men in particular are less likely to participate and are at a higher risk of drop-out from these studies. This intervention aims to determine if using older Black men as peer leaders to other older Black men will improve retention rates for this population.
15762031|NCT04760444|Behavioral|Virtual Diabetes Self-Management Education|Participants will attend 10 hours of virtual group diabetes self-management education classes led by a certified diabetes care and education specialist through the online HIPPA compliant Zoom, Med platform.
15762032|NCT04760431|Drug|Trastuzumab|8 mg/kg loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles, administered by IV infusion every week until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
15762033|NCT04760431|Drug|Taxanes|Docetaxel: 75 mg/m2, administered by IV infusion every 3 weeks Paclitaxel: 175 mg/m2, administered by IV infusion every 3 weeks Paclitaxel (Albumin bound): 260 mg/m2, administered by IV infusion every 3 weeks Paclitaxel Liposome: 135-175 mg/m2, administered by IV infusion every 3 weeks
15762034|NCT04760431|Drug|Pertuzumab|840 milligrams (mg) loading dose of pertuzumab, followed every 3 weeks thereafter by a dose of 420 mg via intravenous (IV) infusion until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
15762035|NCT04760431|Drug|Tyrosine kinase inhibitor|Pyrotinib: 400mg po within 30 minutes after a meal, QD, every 3 weeks Neratinib: 240mg po QD, every 3 weeks Tucatinib: 300mg po Q12H
15762036|NCT04760418|Behavioral|Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE)|A 12-session integrated cognitive behavioral therapy for posttraumatic stress disorder and substance use
15762037|NCT04760405|Other|Tai Chi Easy|Patients will receive two 30-minute small group training sessions (Via Zoom) within 7 days of their scheduled transplant. After the training has been completed the participant will be provided with written (via manual) and electronic (DVD, MP3 file download) materials to continue with self-direct practice throughout the duration of the study.
15762038|NCT04760392|Behavioral|Goal-directed mobilization|"A short educational intervention with handout of a leaflet on GDM.
~Definition of personal mobility goal level.
~Communication of the mobility goal level to involved stakeholders.
~Regular reassessment of the mobility goal level and booster sessions by physiotherapists."
15762039|NCT04760379|Other|Conventional therapy|Bridging, Stretching exercises (quadratus lumborum, erector spinae) McKenzie exercises and TENS (10 mins).
15762040|NCT04760379|Other|vibration therapy|Focal muscle vibrator (120 Hz) for 10 minutes on paraspinal muscles. Bridging, Stretching exercises (quadratus lumborum, erector spinae) McKenzie exercises and TENS (10 mins).
15762041|NCT04760366|Other|fascial- muscular lengthening therapy|"Patients in this group will receive interventional therapy
~To perform this technique:
~Have the patient in side lying position
~Hip is maximally flexed to shorten the iliopsoas muscle.
~Therapist fingers should be on to the targeted area.
~Apply gentle pressure in upward direction.
~While maintain the pressure, stretch the muscle by moving the hip in extension through full ROM.
~Therapist will maintain the pressure in opposing direction. This is considered as one pass. This technique is performed bilaterally. Patients in this group will also receive the conventional therapy which will include:
~Hot pack for 15 minutes.
~Myofascial release of iliopsoas.
~TENS for 15 minutes."
15762042|NCT04760366|Other|Stretching's of iliopsoas muscle|"Patients in this group will receive the interventional therapy which will include:
~Stretching's of iliopsoas muscle which can be done in two positions:
~modified lunge position.
~The prone stretch.
~Patients in this group will also receive the conventional therapy which will include:
~Hot pack for 15 minutes.
~Myofascial release of iliopsoas
~TENS for 15 minutes."
15762043|NCT04760366|Other|the conventional therapy|the conventional therapy
15762044|NCT04760353|Dietary Supplement|Probiotic mixture (OMNi-BiOTiC STRESS)|OMNi-BiOTiC STRESS containing 9 human bacterial strains [Lactobacillus casei W56, Lactobacillus acidophilus W22, Lactobacillus paracasei W20, Bifidobacterium lactis W51, Bifidobacterium lactis W52, Lactobacillus salivarius W24, Lactococcus lactis W19, Lactobacillus plantarum W62, Bifidobacterium bifidum W23, with at least 7,5 billion CFU per one dose (3 g) and 15 billion CFU per two doses (6 g)] and vitamin B (B2, B6, B12),
15762045|NCT04760353|Other|Placebo|"one powder portion bag self-administered orally twice a day for 8 weeks, identical in all aspects (organoleptic) as investigational product (IP) but containing excipient only.
~Powder portion bags are suitable for participants with intolerance to yeasts or lactose
~Each patient will receive a container with 112 powder portion bags (IP or placebo depending on the randomization) at the randomization period (0 weeks)."
15762046|NCT04760327|Combination Product|Electrochemotherapy with bleomycin or cisplatin|Electrochemotherapy with cisplatin or bleomycin of gynecological cancers
15762047|NCT04760314|Drug|Lebrikizumab|Administered SC
15762048|NCT04760314|Drug|Placebo|Administered SC
15762049|NCT04760314|Drug|Topical Corticosteroid|Self-applied
15762050|NCT04760301|Drug|local tranexamic acid injection|local tranexamic acid injection to cervix- 1 g tranexamic acid diluted in 10 ml saline
15762051|NCT04760301|Other|local normal saline injection to cervix|local normal saline injection to the cervix- 20 ml saline
15762052|NCT04760301|Drug|IV 1 g tranexamic acid|IV 1 g tranexamic acid diluted in 100 ml saline
15762053|NCT04760301|Other|IV 1 g normal saline|IV 100 ml normal saline
15762054|NCT04760288|Drug|Pralsetinib|Participants will receive Pralsetinib at a dose of 400mg, as per the dosing schedule described above.
15762055|NCT04760288|Drug|Cabozantinib|Participants will receive Cabozantinib at a dose of 140mg, as per the dosing schedule described above.
15762056|NCT04760288|Drug|Vandetanib|Participants will receive Vandetanib at a dose of 300mg, as per the dosing schedule described above.
15762057|NCT04760275|Drug|Fluoxetine|"This will be a single-blind SMART design of 24 weeks duration that will employ two sequential levels of randomization, one in each of two 12-week stages of the study.
~In Stage 1, participants will be randomized 1:1 to receive 12 weeks of the medication fluoxetine in upward-titrated dosages. In Stage 2, also 12 weeks in duration, participants who remit during the first 12 weeks of treatment will continue maintenance-level therapy with fluoxetine. All participants who do not remit will be randomized (1:1) to either (1) optimization of fluoxetine (increasing the dose of fluoxetine as tolerated), or (2) optimization of fluoxetine and addition of Cognitive Behavioral Therapy (CBT)."
15762058|NCT04760275|Behavioral|Cognitive Behavioral Therapy (CBT)|"This will be a single-blind SMART design of 24 weeks duration that will employ two sequential levels of randomization, one in each of two 12-week stages of the study.
~In Stage 1, participants will be randomized 1:1 to receive 12 weeks of weekly CBT implemented with Coping Cat (CC). In Stage 2, also 12 weeks in duration, participants who remit during the first 12 weeks of treatment will continue maintenance-level therapy with CBT. All participants who do not remit will be randomized (1:1) to either (1) optimization of CBT (intensifying exposure practice and skills review), or (2) optimization of CBT and addition of the medication fluoxetine."
15762059|NCT04760262|Drug|Sevoflurane|Sevoflurane %2-3 for general anesthesia maintenance, BIS values were arranged 40-60 until the end of operation, In case of tachycardia or hypertension the opioid dose was reduced, in case of bradycardia or hypertension the opioid dose was increased
15762060|NCT04760262|Drug|Propofol|BIS values were arranged 40-60 until the end of operation, In case of tachycardia or hypertension the opioid dose was reduced, in case of bradycardia or hypertension the opioid dose was increased
15762061|NCT04760236|Biological|Oral Cholera Vaccine Simplified (OCV-S)|"Manufacturer: EuBiologics Co., Ltd.
~Oral administration"
15762062|NCT04760236|Biological|Shanchol™|"Manufacturer: Shantha Biotechnics
~Oral administration"
15762063|NCT04760223|Behavioral|Video intervention|a 100-second video, presenting a personal story of a boy/girl dealing with depression
15762064|NCT04760210|Other|Control Group|Treatment for this group is conventional physical therapy along with the bed rest.
15762065|NCT04760210|Other|Decompression Group|Treatment for this is conventional physical therapy along with the spinal decompression.
15762066|NCT04760210|Other|ELDOA|Treatment for this is conventional physical therapy along with the ELDOA.
15762067|NCT04760197|Other|no intervention|no intervention
15762068|NCT04760184|Other|Autologous stem cell transplantation|The study will describe the implications of COVID-19 infection following autologous stem cell transplantation
15762069|NCT04760158|Other|Exercise|Participants of this study exercised strengthening and stretching 3 days a week for 6 weeks
15824811|NCT04245865|Dietary Supplement|Tocotrienol|300 mg orally x 3 daily
15762070|NCT04760145|Other|Multicomponent Exercise with Blood Flow Restriction|"10 minutes of initial warm-up.
~20 minutes of strength exercises.
~10 minutes of resistance exercises.
~10 minutes of coordination and balance exercises.
~5 minutes of flexibility.
~5 minutes of return to calm and relaxation.
~All of this multicomponent training will be performed with blood flow restriction."
15762071|NCT04760145|Other|Multicomponent Exercise without Blood Flow Restriction|"10 minutes of initial warm-up.
~20 minutes of strength exercises.
~10 minutes of resistance exercises.
~10 minutes of coordination and balance exercises.
~5 minutes of flexibility.
~5 minutes of return to calm and relaxation.
~All of this multicomponent training will be performed without blood flow restriction."
15762072|NCT04760132|Biological|COMIRNATY - BioNTech Manufacturing GmbH|Vaccination as part of the the Danish national government programme
15762073|NCT04760132|Biological|COVID-19 Vaccine Moderna dispersion for injection - MODERNA BIOTECH|Vaccination as part of the the Danish national government programme
15762074|NCT04760132|Biological|COVID-19 Vaccine AstraZeneca suspension for injection|Vaccination as part of the the Danish national government programme
15762075|NCT04760119|Procedure|Vein bypass surgery first strategy|Vein bypass will be performed with standart anaesthetic and surgical techniques using reversed great saphenous vein conduit. Location of proximal and distal anastomosis will be recorded. Post surgery completion angiography imaging will be performed.
15762076|NCT04760119|Procedure|Endovascular treatment first (drug coated balloon angioplasty) strategy|Endovascular treatment using drug-coated balloons will be performed under local anaesthetic via common femoral artery. Final angiography imaging will be demonstrated.
15762077|NCT04760106|Diagnostic Test|gastric ultrasound|"For the qualitative assessment, every participant was scanned once by both examiners. Each scan session lasted no longer than 5 minutes to mitigate the confounding effect of gastric emptying time.
~For the quantitative assessment, the participants were put in a right lateral decubitus position and the antral cross-sectional area (CSA) is measured in the sagittal plane."
15762078|NCT04760093|Dietary Supplement|Low polyphenol concentration extra virgin olive oil (EVOO)|Subjects will complete a consecutive 28-day period of consuming low polyphenol concentration EVOO daily.
15762079|NCT04760093|Dietary Supplement|High polyphenol concentration extra virgin olive oil (EVOO)|Subjects will complete a consecutive 28-day period of consuming high polyphenol concentration EVOO daily.
15762080|NCT04760080|Other|pre-treatment data|"We will evaluate in all patients pre-treatment data :
~Melanoma staging at treatment initiation
~Melanoma characteristics at initial diagnosis
~Number and location of metastasis
~Performans status
~Demographic information"
15762081|NCT04760080|Other|during study treatment|"We will evaluate in all patients during study treatment :
~Rate of adverse events
~Type of adverse events
~Radiological response to treatment by CTscans that are routinely performed every three months."
15762082|NCT04760067|Other|Sports Injury Anxiety Scale|Sports Injury Anxiety Scale
15762083|NCT04760054|Behavioral|HUBOD|Participants in the intervention group will attend 5 separate training sessions instructing them in Hubod. The Hubod exercise is a partnered coordination drill involving moves derived from numerous martial arts, most often seen in the Filipino martial art of Kali. Participants will aim to reach a level of comfort and competency in the basic, non-competitive aspects of the Hubod exercise by the end of their participation in this intervention.
15762084|NCT04760054|Behavioral|Active Comparator|Participants in the active comparator group will attend 5 separate training sessions. Each session will involve a 5 minute warmup of joint mobilization exercises and mild pedaling on the bicycle before the main effort of continuously using the bicycle for approximately 20 minutes. The session finishes with a 5 minute cooldown period and light stretch. Heartrate will be monitored regularly in order to prevent this exercise exceeding the relative intensity of the Martial Arts intervention group. Participants will be allowed to talk and interact with research assistants in order to keep socialization effects consistent across groups.
15762085|NCT04760054|Behavioral|Control Condition|Participants in this group will attend 5 separate training sessions. Each session will involve watching educational videos on martial arts techniques and training methods from a sedentary position. Participants will be allowed to talk and interact with research assistants in order to keep socialization effects consistent across groups.
15762086|NCT04760041|Drug|Midazolam nebulized|midazolam nebulized
15762087|NCT04760041|Drug|Midazolam oral solution|midazolam given oral
15762089|NCT04760002|Device|NightOwl|The NightOwl consists of a small sensor device which is placed on the fingertip and a smartphone app that is connected to an encrypted cloud-based analytics platform within the European Union, the NightOwl software. It is self-applied by attaching the sensor to the fingertip by means of an adhesive patch. The NightOwl sensor acquires accelerometer data and reflectancebased photoplethysmography (PPG) from which it derives actigraphy (sleep/wake behavior), SpO2, peripheral artery tone (PAT) and pulse rate, among other features. A PAT analysis derives changes in caliber of arteries elicited by alterations in the contractile activity of vascular smooth muscle and are referred to as changes in arterial tone. The end state of the apnea-hypopnea events are associated with sympathetic activation.
15762090|NCT04759989|Procedure|Actual Body Weight Dosing|30cc/kg initial bolus calculated using Actual Body Weight
15762091|NCT04759989|Procedure|Adjusted Body Weight Dosing|30cc/kg initial bolus calculated using Adjusted Body Weight
15762092|NCT04759989|Procedure|Ideal Body Weight Dosing|30cc/kg initial bolus calculated using Ideal Body Weight
15762093|NCT04759976|Behavioral|Robotic motor training|The experiments consist in performing motor tasks with upper-limb robotic devices.
15762094|NCT04759950|Behavioral|Multicomponent Physical Activity Program|The proposed physical exercise intervention follows the American College of Sports Medicine (ACSM, 2017) and the American Stroke Association (Billinger et al., 2014) recommendations for stroke patients. The five weekly 45-minute sessions are divided into (1) three sessions guided and supervised telematically by a physical exercise specialist and a physiotherapist; (2) and two autonomous exercise sessions. The supervised sessions include exercises to work aerobic capacity, muscle strength and endurance, flexibility, agility, and balance. The intensity of these exercises is prescribed individually according to each participant's initial level and are gradually increased as the program progresses. Participants are encouraged to walk at a similar intensity on autonomous physical exercise days as performed in the guided sessions (moderate intensity), based on the Borg scale of perceived exertion (Borg, 1982).
15762095|NCT04759950|Behavioral|Mindfulness-Based Stress Reduction Program|This intervention follows an adaptation of the scheme and instructions of the official Mindfulness-Based Stress Reduction (MBSR) program designed by Jon Kabat-Zinn. It includes body scanning, sitting meditation, and gentle hatha yoga techniques. An accredited mindfulness instructor leads the 12-week online program, which comprises a presentation session, followed by eight intervention sessions (once a week, lasting 2.5 hours) and an intensive practice session interspersed between sessions six and seven. Apart from the supervised session, the therapist asks participants to carry out some independent practice daily.
15762096|NCT04759950|Behavioral|Computerized Cognitive Training|An accredited neuropsychologist programs and supervises the computerized cognitive training through the Guttmann Neuropersonal Trainer (GNPT®) platform. The 12-week program consists of five sessions a week (45 minutes each) that include personalized activities planned to stimulate executive functioning, attention, processing speed, and memory.
15762097|NCT04759911|Other|Quality-of-Life Assessment|Ancillary studies
15762098|NCT04759911|Other|Questionnaire Administration|Ancillary studies
15762099|NCT04759911|Drug|Selpercatinib|Given PO
15762100|NCT04759911|Procedure|Therapeutic Conventional Surgery|Undergo standard of care surgery
15762101|NCT04759898|Device|transcranial direct current stimulation (noninvasive recording)|Subjects will enter the EEG lab and be seated in a chair. The 26-electrode EEG array will be placed using a conductive paste. The electrodes will be connected to a clinical grade EEG machine used in standard of care routine EEG monitoring. Next, a soft cloth cap will be placed over the subject's head with the tDCS electrodes pre-positioned in place. The cap will be positioned so that the tDCS electrodes cover the scalp without disturbing the underlying EEG electrodes. Conducting gel will be applied in direct contact with the scalp to facilitate stimulation. In addition, lidocaine jelly will be added topically to provide local anesthesia. The tDCS electrodes will be connected to a low-current generator. Participants receive 2.0 milliamps in electrical stimulation from the tDCS machine for 20 minutes. The device will be manually controlled by study personnel assisting with the experiment. A virtual reality environment will be utilized to collect kinematic data during the study.
15762102|NCT04759898|Device|sham transcranial direct current stimulation (noninvasive recording)|Subjects receiving sham undergo the same setup as the stimulation group with the exception that sham subjects experience stimulation for one minute only (30 second ramp-up to 2 milliamps immediately followed by 30 second ramp-down to 0 milliamps for the remaining 19 minutes). This provides similar sensory feedback to sham subjects that treatment subjects experience. The same electrode array, soft cloth cap, conducting gel application, and lidocaine are applied as in a stimulation subject. The tDCS electrodes will be connected to a low-current generator. A virtual reality environment will be utilized to collect kinematic data during the study.
15762103|NCT04759898|Device|transcranial direct current stimulation (invasive recording)|Subjects are brought into the operating room. The scalp is prepped with a sterilizing solution. Following infiltration with local anesthetic and incision, a 6-contact electrocorticography strip is inserted into the burr hole covering primary motor cortex. Electrocorticography strip terminals are connected to an amplifier for signal recording. Gas-sterilized transcranial direct current stimulation electrodes are placed on the scalp directly overlying primary motor cortex. tDCS electrodes are connected to a low-current generator. During electrocorticographic recording, stimulation is turned on while subjects are asked to flex each arm. At the conclusion of the experiment, the electrocorticography strip and tDCS electrodes are removed and the surgery proceeds as planned.
15762104|NCT04759885|Drug|NTC015 low dose|Participants should self administer the preparation within 30 minutes and drink one litre of clear liquid in the next hour according to local practice at the centre to prevent dehydration
15762105|NCT04759885|Drug|NTC015 medium dose|Participants should self administer the preparation within 30 minutes and drink one litre of clear liquid in the next hour according to local practice at the centre to prevent dehydration
15762106|NCT04759885|Drug|NTC015 high dose|Participants should self administer the preparation within 60 minutes and drink one litre of clear liquid in the next hour according to local practice at the centre to prevent dehydration
15762107|NCT04759885|Drug|Polyethylene glycol plus ascorbate solution (2L PEG ASC)|"One treatment consists of two litres of Moviprep® taken according to split-dose regimen.
~The first litre of Moviprep® is prepared by dissolving one sachet A and one sachet B together in water to make one litre of solution. The reconstituted solution must be drunk over a period of one to two hours the evening before colonoscopy. About half a litre of clear liquid should be drunk in the next hour to prevent dehydration according to local practice at the centre. This process should be repeated with a second litre of Moviprep® prepared by dissolving one sachet A and one sachet B together in water to make one litre of solution in the early morning of the day of the procedure."
15762108|NCT04759872|Other|Hyperinsulinemic-euglycemic Clamp|Participants will be administered a constant-rate insulin infusion (to induce mild hyperinsulinemia), with an infusion of dextrose to maintain blood glucose concentration (to maintain euglycemia).
15762109|NCT04759846|Drug|Encorafenib + Binimetinib|The doses administered to patients with normal hepatic function will be the same as the recommended commercialised doses
15762110|NCT04759846|Drug|Encorafenib + Binimetinib|A smaller dose than the dose approved for patients with normal hepatic function has been defined
15762111|NCT04759846|Drug|Encorafenib + Binimetinib|A smaller dose than the dose approved for patients with normal hepatic function has been defined
15762112|NCT04759833|Drug|Prucalopride|Participants will receive 0.04 mg/kg or 0.08 mg/kg oral solution or 2 mg oral tablet of prucalopride QD.
15762113|NCT04759833|Other|Placebo|Participants will receive matching placebo of oral solution or tablet QD.
15762114|NCT04759820|Drug|injecting Carbon Nanoparticles Suspension|injecting Carbon Nanoparticles Suspension for lymph node detection
15762115|NCT04759820|Drug|Injecting indocyanine green|Injecting indocyanine green for lymph node detection
15762116|NCT04759807|Drug|Placebo Comparator|The placebo designed for administration in the proposed clinical study consists of a dry powder composed of the same excipients as the active (sodium sulfate, mannitol and polysorbate 80), pre-metered into HPMC capsules at the same 5 mg powder fill weight as the active formulations. Subjects will receive 14 doses administered once daily in the morning.
15762162|NCT04759534|Biological|protein convertase subtilisin/kexin type 9 inhibitor|IBI306 is a kind of protein convertase subtilisin/kexin type 9 inhibitor.Received abdominal subcutaneous injection of IBI306 150 mg Q2W or 300 mg Q4W
15824812|NCT04245865|Other|Placebo|Placebo orally x 3 daily
15762117|NCT04759807|Drug|PUR1800 250 ug|The PUR1800 drug product intended for use in the proposed clinical study comprises bulk powder containing 5 wt% or 10 wt% RV1162 pre-metered into HPMC capsules for oral delivery via a passive DPI. The capsules contain 5 milligrams (mg) of the powder formulation, corresponding to a 250 μg nominal dose strength of RV1162. Subjects will receive 14 doses administered once daily in the morning.
15762118|NCT04759807|Drug|PUR1800 500 ug|The PUR1800 drug product intended for use in the proposed clinical study comprises bulk powder containing 5 wt% or 10 wt% RV1162 pre-metered into HPMC capsules for oral delivery via a passive DPI. The capsules contain 5 milligrams (mg) of the powder formulation, corresponding to a 500 μg nominal dose strength of RV1162. Subjects will receive 14 doses administered once daily in the morning.
15762119|NCT04759794|Diagnostic Test|Cytology staining|"Two stainings will be performed in cytology specimens obtained from the same patient. The cytology specimen will be obtained through brushing cytology using endoscopic retrograde cholangiopancreatography
~conventional cytology staining method
~new cytology staining method using the antibody of aminoacyl-tRNA synthetases"
15762122|NCT04759742|Drug|ropivacaine|According to previous clinical experience, 0.5% ropivacaine was given in the subarachnoid cavity, and the initial dose was set at 2.5 mL (12.5mg). Dixon's up-and down method was adopted to adjust or down-adjust the dose of ropivacaine in the next patient according to the experimental results of the previous patient, and the adjusted dose was 0.1 mL (0.5mg).
15762123|NCT04759729|Combination Product|Probiotic and vitamin D|"Participants enrolled to PRO + D group will receive probiotics and vitamin D supplements as a intervention product.
~Participants enrolled to probiotic group will receive probiotics as well as vitamin D supplements."
15762124|NCT04759729|Dietary Supplement|placebo and vitamin D|Participants enrolled to PL+D group will receive vitamin D. Additionally they will get placebo instead of probiotics.
15762125|NCT04759716|Other|Health Literacy-based Weight Control Intervention|intervention arm will be applied to receive health literacy-based mobile Health App, smart sports watch Fitbit versa during the 12 months weight control program
15762126|NCT04759703|Drug|Pramipexole|0.25 mg pramipexole tablets
15762127|NCT04759703|Drug|Placebo|Matching placebo tablets
15762128|NCT04759690|Behavioral|Action observation|Action observation group: The participants will first watch the conventional balance exercises with the action observation method on video for 15 minutes.After watching of conventional balance exercise for 30 minutes in 8-10 repetitions.
15762129|NCT04759690|Behavioral|Exercise group|Exercise group is the control group.TheParticipants will only do the conventional balance exercise without action observation for 30 minutes in 8-10 repetitions.
15762130|NCT04759677|Other|Exercise with active video games|45-minute exercise in which individuals played pre-selected games from Nintendo Wii while keeping in mind their functional level, skills and needs. Four Nintendo Wii games were chosen: Island Cycling, Tilt Table Balance Board, Soccer Heading and Boxing. Each and every individual played these given four games consecutively in one session.
15762131|NCT04759664|Drug|LUT014 Gel (Dose 1)|Topical gel
15762132|NCT04759664|Drug|LUT014 Gel (Dose 2)|Topical gel
15762133|NCT04759664|Drug|Placebo|LUT014 matching placebo topical gel
15762134|NCT04759651|Other|Functional Outcome of Sleep Questionnaire Turkish version (FOSQ-TR)|Sleep related quality of life questionnaire.
15762135|NCT04759651|Other|Epworth Sleepiness Scale (ESS)|Subjective level of daytime sleepiness.
15762136|NCT04759651|Other|Berlin Questionnaire|Evaluation of high-risk for Obstructive Sleep Apnea.
15762137|NCT04759651|Other|Stop-Bang Questionnaire|Evaluation of high-risk Obstructive Sleep Apnea.
15762138|NCT04759651|Other|Insomnia Questionnaire|Subjective evaluation of insomnia.
15762139|NCT04759651|Other|Restless Leg Syndrome Questionnaire|Subjective evaluation of Restless Leg Syndrome.
15762140|NCT04759651|Other|Zung Self-rating Depression Scale (SDS)|Subjective test for evaluation of depressive mood.
15762141|NCT04759651|Other|Beck Anxiety Inventory|Subjective test for evaluation of anxiety.
15762142|NCT04759625|Other|Novel biscuit enriched with mushroom powder containing 3g of β-glucans|Daily consumption of a novel biscuit enriched with mushroom powder containing 3g of β-glucans
15762143|NCT04759625|Other|Placebo biscuit|Daily consumption of placebo biscuit
15762144|NCT04759612|Other|Action Observation|Participants will watch an upper extremity functionality test.
15762145|NCT04759599|Procedure|Shock Wave Lithotripsy (SWL)|Shock Wave Lithotripsy (SWL) with focal size 2mm (F1), and 3000 shocks or Shock Wave Lithotripsy (SWL) with focal size 8mm (F3), and 3000 shocks
15762158|NCT04759573|Behavioral|Early Vocal Contact|Mothers will be asked to speak and sing to their infants continuously over a 10-min period for each type of intervention (20 min in total). Mothers will be asked to talk in their native language and to sing familiar songs, while observing their infant's reactions. The order of the two vocalizations, speaking and singing, will be reversed in the next intervention.
15762159|NCT04759573|Behavioral|Behavioral Observation|Mothers in the active control group will be encouraged to spend the same amount of time next to the incubator, observing the infant's behaviours through a standard cluster of indicators.
15762160|NCT04759547|Device|handheld ultrasound-assisted technique|Ultrasound with 3D navigation function is used to determine the needle insertion point and the insertion angle.
15762161|NCT04759547|Other|conventional palpation-guided technique|The interspinous space is detected by palpation
15762233|NCT04758923|Procedure|Cholecystectomy|Under General anaesthesia cholecystectomy and CBD exploration
15762163|NCT04759508|Dietary Supplement|Flax Oil Capsule|Flaxseed with brand name Flax Oil Capsule will be administered to subjects receiving antihypertensives.
15762164|NCT04759508|Dietary Supplement|Placebo Soya Oil Capsule|Placebo capsule filled with soya oil and inert(inactive) substances will be administered to subjects remaining anti hypertensives.
15762165|NCT04759495|Device|Continuous Glucose Monitoring Dexcom G5 and G6 system (real-time continuous glucose monitoring)|rtCGM is used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.
15762166|NCT04759495|Device|Continuous Glucose Monitoring FreeStyle Libre Flash system (flash glucose monitoring)|FGM is used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.
15762167|NCT04759482|Diagnostic Test|polysomnography|Polysomnography consisted in recording sleep parameters during one night, using a non-invasive multi-channels device, including respiratory sensors, electrocardiogram and electroencephalogram
15762168|NCT04759469|Behavioral|High-intensity interval training|High-intensity interval training is a form of intermittent training using relatively high exercise intensity
15762169|NCT04759469|Behavioral|Moderate intensity interval training|Moderate intensity interval training is a form of intermittent training using moderate exercise intensity
15762170|NCT04759456|Other|Remotely-supervised rehabilitation program|Include nutrition, health-related lifestyle and behavioral changes recommendations, and at least 5 times a week 30 minutes of moderate-intensity aerobic training, 10 minutes of inspiratory and expiratory muscle training with breathing device and 10 minutes of oropharyngeal exercise along with individually titrated CPAP therapy
15762171|NCT04759443|Other|Image processing of skin|Image processing will be used to extract skin features that correlate with loss of small skin fibers.
15762172|NCT04759430|Other|Supervised Group|Individuals will apply ten different stabilization exercises in company with a physiotherapist.
15762173|NCT04759430|Other|Telerehabilitation group|Same stabilization exercises will be performed online with the patient by the researcher physiotherapist and supervised through the video conference or phone.
15762174|NCT04759404|Other|Deep Oscillation Treatment|Deep oscillation to the lumbar region and stretching and strengthening exercise for waist, back and abdominal
15762175|NCT04759404|Other|Myofascial Release Treatment|Myofascial release to the lumbar region and stretching and strengthening exercise for waist, back and abdominal
15762176|NCT04759391|Other|Exercise|Pelvic floor muscle training program planned under the supervision of a physiotherapist was applied and followed to the exercise group, using the digital application.
15762177|NCT04759391|Other|Lifestyle recommendations|Information was given within the scope of lifestyle recommendations (fluid intake, diet, constipation, weight control, smoking related to lower urinary system symptoms
15762178|NCT04759378|Diagnostic Test|Upper endoscopy, esophageal manometry, 24-hour pH monitoring|upper endoscopy determines if there are structural abnormalities in upper Git. esophageal manometry determines if there are motility disorders. 24-hour pH monitoring determines if acid reflux is present or not, and specifies its rate and duration.
15762179|NCT04759365|Drug|ASN51|ASN51 formulation for oral capsule
15762180|NCT04759365|Drug|Placebo|Placebo formulation for oral capsule
15762181|NCT04759352|Other|Post-test genetic counseling delivered by telephone|Participants enrolled in the experimental arm will receive genetic counseling for test result communication by telephone.
15762182|NCT04759339|Drug|AG-920|AG-920 is a sterile, isotonic, non-preserved aqueous solution containing the active ingredient Articaine HCl 8%
15762183|NCT04759326|Other|Hippotherapy|Hippotherapy is an emerging specialized rehabilitation approach, performed on a specially trained horse via its movement at a walk by accredited health professionals (e.g., physicians, psychologists, physical therapists, occupational therapists, psychomotor therapists, chiropractors ...). The horse is an excellent support for temporary or consolidated disabilities, providing key elements of recovery for impairment, activity limitation, and participation restriction. It is a dynamic activity where the amplitude of movement of the patient's body transmitted by the horse is similar to the human walking (micro-movements of postural muscles). Moreover, through multimodal inputs (sensory, exteroceptive, proprioceptive, interoceptive), hippotherapy has a direct action on the individual's motor capacities and cognitive abilities. The degree of change relying on neuroplasticity is linked both to the relevance of the activity and to the intensity and frequency of the elements that constitute it.
15762184|NCT04759326|Other|Conventional Neurorehabilitation|The neurorehabilitation therapy is an intervention from two or more disciplines (physiotherapy, occupational therapy, social work, psychology and other related disciplines, nursing) prescribed by a medical specialist (neurologist, neurosurgeon, oncologist, physiatrist). It is designed to be patient-centered, time-limited and functionally oriented, and aims to maximize activity and participation (social inclusion) using a biopsychosocial model.
15762185|NCT04759313|Behavioral|Image Narrative|Each participant will take part in a 5-week program of weekly 1-hour telehealth sessions with the PI or a social work PhD student facilitator trained in the INI by the PI.
15762186|NCT04759300|Device|C-MAC VS|patients undergoing tracheal intubation using the C-MAC VS
15762187|NCT04759300|Device|C-MAC VL D -blade|patients undergoing intubation using the C-MAC VL D-blade.
15762188|NCT04759287|Device|C-MAC VS|The first group (VS group) will include patients undergoing awake intubation using the C-MAC VS
15762189|NCT04759287|Device|flexible fibreoptic bronchoscope|The second control group (FOB group) will include patients undergoing awake intubation using the flexible fibreoptic bronchoscope.
15762191|NCT04759261|Other|SMAD4 expression and methylation|Effect of SMAD4 methylations on smad4 expression
15762192|NCT04759248|Drug|Atezolizumab + Trastuzumab + Vinorelbine|"Atezolizumab IV 1200 mg in combination with
~Trastuzumab sc 600mg or IV 6mg/kg every 3 weeks and
~Vinorelbine 25 mg/m² IV or 60 mg/m2 PO on days 1 and 8, every 3 weeks during the first cycle and if there are no toxicity signs dose will be increased to 80 mg/m2 PO o 30 mg/m2 IV."
15762193|NCT04759235|Diagnostic Test|Magnetic resonance imaging (MRI)|Anatomical (T2W) and functional MRI (DWI) at a 3.0T Siemens or Philips scanner Three MRI scan series (before, during, after nCRT) Measurements: change in apparent diffusion coefficient (ADC)
15762234|NCT04758910|Device|High Flow Oxygen Therapy|A 30-minute spontaneous breathing trial using high flow oxygen therapy via tracheostomy.
15762194|NCT04759235|Diagnostic Test|18F-Fluorodeoxyglucose (FDG)-positron emission tomography/computed tomography (PET/CT)|PET-CT scan at diagnosis and 4-6 weeks after nCRT before operation Measurements: change in TLG (Total Lesion Glycolysis), SUVmax (Standardized Uptake Value)，MTV（Metabolic tumor volume）
15762195|NCT04759235|Diagnostic Test|Blood and urine metabolic biomarker|Blood and urine specimens are collected before radiotherapy, the third week of radiotherapy, and at the end of radiotherapy.
15762196|NCT04759222|Diagnostic Test|vascular occlusion test|The VOT was performed five times in each patient, before the induction of general anesthesia (baseline, T0), 30 min after the induction of general anesthesia (T1), 30 min after applying CPB (T2), 10 min after injection of protamine (T3), and after sternal closure (T4). Before induction of anesthesia, an NIRS sensor was placed on the thenar eminence and an automated tourniquet was placed around the upper arm. The arterial catheter was placed in the contralateral radial artery and the baseline blood pressure was measured. When the baseline tissue oxygen saturation (StO2) was stabilized, the automatic tourniquet was inflated to 50 mmHg over the patient's baseline systolic blood pressure and maintained for 5 min. After the 5-min ischemic period, the tourniquet rapidly deflated to 0 mmHg. StO2 data were continuously recorded during the VOT procedure.
15762197|NCT04759209|Diagnostic Test|Biopsies|
15762198|NCT04759196|Drug|Topamax|TPM : 50 mg BID, with increased of 50 mg by week until efficacy, to a maximum of 100 mg BID.
15762199|NCT04759196|Drug|Levetiracetam|LEV : 500 mg BID, with increase of 1000 mg die divided in two doses each week until efficacy, to a maximum of 1500 mg BID.
15762200|NCT04759183|Other|Survey Administration|Ancillary studies
15762201|NCT04759183|Procedure|Virtual Reality Game|"Participate in VR Game Angry Birds"
15762202|NCT04759183|Procedure|Virtual Reality Meditation|"Participate in VR Meditation TRIPP"
15762203|NCT04759170|Other|Music therapy|The effects of receptive music therapy on oral nutrition and the well-being of the Italian premature baby
15762204|NCT04759157|Behavioral|Couples-based treatment|Couples will attend 3, video based sessions for couples-based treatment
15762205|NCT04759157|Other|Standardized education|Patients will receive standardized educational materials
15762208|NCT04759131|Drug|efanesoctocog alfa (BIVV001)|Pharmaceutical form:solution for injection Route of administration: Intravenous
15762209|NCT04759118|Behavioral|modified childbirth education program|The participants in the intervention group are pregnant women and their husbands. The instructors employed teaching methods such as a group discussion, watching videos, and brainstorming, as well as questions and answer periods, demonstrations, childbirth simulation, and practice. The primary investigator (PI) will teach particular sessions, including maternal-fetal attachment skills, parenting skills, comfort measures, childbirth positions, as well as knowledge about anatomy and physiology during pregnancy and birth Classes consisted of 120-minute sessions held once a week for four weeks.
15762210|NCT04759105|Drug|Autologous BM-MSC|intradiscal injection of autologous bone marrow mesenchymal stromal/stem cells
15762211|NCT04759105|Other|Sham Procedure|anaesthesia, no disc injection, no placebo injection
15762212|NCT04759092|Device|transcranial direct current stimulation (tDCS)|Apply 30min low dose (2mA) transcranial current stimulation on the scalp every day for four months.
15762213|NCT04759079|Device|Acupuncture Needles|Acupuncture Needles placement at the PC6 in association to anti-emetic medication
15762214|NCT04759079|Drug|Antiemetic Drug|Administration of Anti-emetic medication without acupuncture
15762215|NCT04759066|Device|HEALiX|HEALiX is a non-restraint patient safety device
15762216|NCT04759053|Procedure|FNB|Fine needle aspiration from the nodules
15762217|NCT04759053|Procedure|Core biopsy|Core biopsy from thyroid nodules
15762218|NCT04759040|Dietary Supplement|Migraineguard|2 Capsules per day for 7 Months
15762219|NCT04759027|Other|subacromial distance measurement|distance between acromion and humerus
15762220|NCT04759014|Other|The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of life|The effect of using two different prosthetic feet on functional capacity, pain severity, satisfaction level and quality of life
15762221|NCT04759001|Biological|Donor FMT|This intervention is represented by the administration, in the recipients' gut, of donor microbiota through FMT
15762222|NCT04759001|Other|Placebo FMT|This intervention is represented by the administration, in the recipients' gut, of a placebo through FMT
15762223|NCT04758988|Other|DermLoop Learn|DermLoop Learn is our AI augmented digital online educational system with case training on a library of 10,000+ benign and malignant skin lesion as well as written learning modules for the most common skin lesion diagnosis.
15762224|NCT04758975|Drug|Venetoclax|VENETOCLAX: Ramp-up than 400 mg QD
15762225|NCT04758975|Drug|Rituximab|RITUXIMAB: Cycle 7 Day 1 375 mg/m2; Cycles 8-12 Day 1 500 mg/m2
15762226|NCT04758975|Drug|Ibrutinib|IBRUTINIB 420 mg QD
15762227|NCT04758962|Biological|1 µg CoV2 SAM (LNP)|2 doses of 1 µg CoV2 SAM (LNP) vaccine in 0,1-month schedule, administered IM in the deltoid of the non-dominant arm.
15762228|NCT04758949|Drug|FL-101|200 mg administered intravenously every 2 weeks prior to surgery.
15762229|NCT04758949|Drug|Nivolumab|240 mg administered intravenously every 2 weeks prior to surgery.
15762230|NCT04758949|Drug|Placebo|200 mg administered intravenously every 2 weeks prior to surgery.
15762231|NCT04758936|Drug|Clonidine|The doses administered (clonidine 1500mg diluted in NaCl0.9% solution of 50 ml) ranged from 0.01μg/kg/min to 0.03μg/kg/min.
15762232|NCT04758936|Drug|Dexmedetomidine|The doses administered (dexmedetomidine 200mg diluted in NaCl0.9% 50ml) ranged from 0.4μg/kg/h and can be titrated up to 1.4μg/kg/h.
15762236|NCT04758897|Drug|Recombinant Human IL12/15-PDL1B Oncolytic HSV-1 Injection (Vero Cell))|Intratumoral injection only. The dosing date can be the Day 1 only or Days 1 through 5.
15762237|NCT04758884|Other|Telemedicine|Visits by videoconference in months 0, 1, 2, 3, 4 and 6.
15762238|NCT04758871|Drug|Dydrogesterone 10 MG Oral Tablet|10 mg three times daily
15762239|NCT04758871|Drug|Micronized progesterone|2x 200 mg vaginal tablets two times daily
15762240|NCT04758858|Other|Insulin treatment optimization with participant's usual diet|Two weeks before the intervention phase, insulin dose optimization and revision of participants' knowledge on carbohydrates counting, hypo- and hyperglycemia prevention and treatment will be done with a nurse and a dietitian under a physician's supervision. Once to twice a week, participants will be contacted to review if glucose values are in target.
15762241|NCT04758858|Device|Abbott's FreeStyle Libre|During the whole trial, blood glucose will be assessed by intermittent scanning Continuous Glucose Monitors (isCGM; Abbott's Freestyle-Libre glucose sensor). Participants will be asked to record or download, in their Freestyle Libre reader or in their insulin pump, their insulin doses being injected each day.
15762242|NCT04758858|Other|Three-day food journal|Two weeks before the intervention phase, participants will be asked to complete a 3-day food journal, using the Keenoa mobile application, with carbohydrates (CHO) content of food and blood glucose measures to optimize their insulin doses. Analysis of the food journal will allow us to quantify the participants' usual diet.
15762243|NCT04758858|Other|Medical visit|During visit 1, a short medical interview will be done to establish if the subject is eligible to participate in the study. A list of current medications, presence of complications, as well as comorbidities associated with their diabetes will be collected in their medical file during the visit with the endocrinologist.
15762244|NCT04758858|Other|Blood pressure measurements|Blood pressure (systolic and diastolic blood pressure) will be measured during all visits (visits 1 to 4).
15762245|NCT04758858|Other|Anthropometric parameters measurements|Weight, height, BMI and waist circumference will be measured during all visits (visits 1 to 4).
15762246|NCT04758858|Other|Indirect calorimetry test|Both resting metabolic rate and respiratory quotient will be measured after a 10-hour fast by indirect calorimetry. The test will be done twice, before (visit 2) and after (visit 4) the intervention phase.
15762247|NCT04758858|Other|Well-being questionnaire|Participants will be asked to complete a well-being questionnaire (nausea, fatigue, etc) during visits 2, 3 and 4.
15762248|NCT04758858|Other|Diet appreciation questionnaire|Participants will be asked to complete a diet appreciation (appetite, fullness, etc) questionnaire during visits 3 and 4.
15762249|NCT04758858|Device|Pedometer (PiezoRxD)|Participants will be asked to wear a pedometer (PiezoRxD) that will record their steps every day during the whole trial. Also, they will have to install Piezo: Achieve the Guidelines!, a free mobile application, on their smartphone or tablet. It will connect to their pedometer via bluetooth and will help the research assistant track their data remotely
15762250|NCT04758858|Other|Hepatic imaging (MRI)|Imaging of participants' liver will be done by MRI at the Centre Hospitalier de l'Université de Montréal (CHUM). The test will be done twice, before (visit 2) and after (visit 4) the intervention phase.
15762251|NCT04758858|Other|Glucagon efficiency test|The glucagon efficiency test will be done twice, before (visit 2) and after (visit 4) the intervention phase. A subcutaneous insulin injection based on individual insulin correction factor will be given to induce hypoglycemia down to 3 mmol/L (based on plasma glucose). A subcutaneous injection of 300 µg of glucagon will be administered.
15762252|NCT04758858|Other|Body composition : Dual Energy X-ray absorptiometry (DEXA)|Lean body mass and fat mass will be measured by Dual Energy X-ray absorptiometry (DEXA). The DEXA test will be done twice, before (visit 2) and after (visit 4) the intervention phase.
15762253|NCT04758858|Other|Blood tests|Blood tests will be done to assess participants' diabetes control as well as to assess other biochemical markers (blood lipids as well as markers of inflammation and liver function). Blood will be collected and analyzed during all visits (visits 1 to 4).
15762254|NCT04758858|Other|Stool sample collections (optional)|Participants will be asked to collect and immediately freeze their stool sample until it is given to the study team (for intestinal microbiota composition analysis). This will be done three times during the study, during phase 1, between week 1 and 6 of phase 2 and between week 6 and 12 of phase 2.
15762255|NCT04758858|Other|Hypoglycemia journal|During the whole trial, participants will be asked to keep a log of their hypoglycemia episodes, which are defined by the need to consume CHO. They will be asked to note the time, symptoms (including time taken for disappearance after treatment), capillary glucose measurement and the amount of CHO consumed.
15762256|NCT04758858|Other|Ketone journal|During the intervention phase, participants will be asked to measure their ß-hydroxybutarate level (mmol/L) with their Abbott's Freestyle-Libre scanner at least twice per week before breakfast. Participants will be asked to check their ketone bodies for sensor or capillary glucose levels exceeding 15 mmol/l, when their sensor indicates high without a specific glucose value and when they have symptoms of ketoacidosis (regardless of glucose reading).
15762257|NCT04758858|Other|Adherence to the diet (Keenoa)|During the whole dietary intervention phase (phase 2), participants will confirm that they have followed their menus by taking before and after pictures of their meals every day and indicating the percentage of their meal consumed (25-50-75-100%) via the Keenoa mobile application.
15762258|NCT04758845|Dietary Supplement|Cocktail|Subjects will consume 2B CFU once daily containing .5B CFU DE111, .5B CFU MIT411, .5B CFU CGI314, and .5B CFU CSI08 for 45 days.
15762259|NCT04758845|Dietary Supplement|CGI314|Subjects will consume 1B CFU of CGI314 once daily for 45 days.
15762260|NCT04758845|Dietary Supplement|CSI08|Subjects will consume 1B CFU of CSI08 once daily for 45 days.
15762261|NCT04758845|Dietary Supplement|MIT411|Subjects will consume 1B CFU of MIT411 once daily for 45 days.
15762262|NCT04758819|Procedure|Comprehensive chromosomal Testing of Trophectoderm biopsies of Blastocysts (CTTEB)|In vitro Fertilization by ICSI then embryo culture until Day 5/6; all blastocysts with morphological scores compatible with TE biopsy and vitrification will be submitted to Comprehensive chromosomal Testing of Trophectoderm biopsies of Blastocysts (CTTEB) and vitrified.
15762263|NCT04758806|Biological|Fecal microbial transplantation|Procured faeces procured from unrelated donor
15762264|NCT04758793|Other|blood samples|3 citrated tubes and 3 EDTA tubes
15762265|NCT04758793|Other|biopsy of abdominal paroie|a muscle biopsy will be performed on the incision area
15762268|NCT04758754|Other|Training|8-weeks iso-volume active (SLKE) or passive static stretching training (PST) involving lower limb muscles
15762269|NCT04758741|Behavioral|Acceptance and Commitment Therapy|Investigating the impact of Acceptance and Commitment Therapy on Resiliency in women affected by domestic violence
15762270|NCT04758741|Other|placebo|This rct has one arm and health education is done only for the purpose of blinding the study so that the participant does not know which of the control or intervention groups it is in and has no comparative aspect and has nothing to do with resilience
15762271|NCT04758728|Procedure|Great saphenous vein stripping and varicectomies|Removal of the great saphenous vein (partially - from just below the knee up to the saphenofemoral junction) by two 3cm skin and subcutaneous fat incisions and the introduction of a conventional vein stripper device, under general or epidural/regional anesthesia. Removal of varicose veins of the lower limb by 0,5cm skin incisions and the use of a conventional phlebectomy stainless steel hook. Mechanical hemostasis by direct compression of the thigh for 10 minutes.
15762272|NCT04758728|Drug|Epinephrine Topical|Use of epinephrine/adrenaline solution 1:1000 topically
15762273|NCT04758728|Drug|normal saline|Use of normal saline solution NaCl 0,9% topically
15762274|NCT04758715|Other|Food provided from a commercial meal service provider for a week|Meals from a commercial meal service provider provide for a week to participant
15762275|NCT04758702|Biological|L-PRF (Leucocyte- platelet rich fibrin)|Leucocyte-Platelet rich fibrin is a high density fibrin clot. it serves as a biological healing matrix by supporting cell migration and cytokine release, expanding the range of its potential applications greatly. Patient's own blood is centrifuged using (Intra-spin) FDA approved centrifuge on 45 degrees angle on 2700 rpm for 12 minutes.
15762276|NCT04758702|Biological|H-PRF (Horizontal -platelet rich fibrin)|Platelet rich fibrin is a high density fibrin clot. it serves as a biological healing matrix by supporting cell migration and cytokine release, expanding the range of its potential applications greatly.Horizontally centrifuged platelet rich fibrin using (Bio-prf) centrifuge on 700 g force for 8 minutes. On a horizontal centrifugation, the cells separate much more efficiently throughout the entire membrane. This leads to better layer separation and also favors cells that are evenly distributed throughout the PRF clot.
15762277|NCT04758702|Device|Surgical stent|An essix surgical stent will be obtained using a high vacuum suction and used to protect the denuded donor site after suturing the wound. (Biostar® Scan/Biostar®V) will be used to make the stent.
15762278|NCT04758689|Combination Product|Laser, exercise, and methotrexate|Laser therapy at acupuncture points, aerobic exercise, and methotrexate
15762279|NCT04758689|Combination Product|Exercise, and methotrexate|Aerobic exercise, and methotrexate
15762280|NCT04758676|Other|Nutritional and physiotherapy protocol, BIA|Study subjects will be treated using the nutritional and physiotherapy protocol, based upon the results of measurements, using bioimpedance analysis.
15762281|NCT04758676|Other|Standard of care|Study subjects will receive the current standard of care.
15762282|NCT04758663|Behavioral|Nap/wake conditions on memory|Habitual and non-habitual napping children will complete a two conditions-a nap condition where they are encouraged to nap in the afternoon and a wake condition where instead of napping, they spend an equal amount of time awake engaging in quiet activities.
15762283|NCT04758663|Behavioral|Nap/wake conditions on overnight physiology|Habitual and non-habitual napping children will complete a two conditions-a nap condition where they are encouraged to nap in the afternoon and a wake condition where instead of napping, they spend an equal amount of time awake engaging in quiet activities. On the nights of the nap and wake conditions, physiology will be recorded in habitual and non-habitual nappers.
15762284|NCT04758650|Drug|68GaNOTA-Anti-MMR-VHH2|All subjects will receive at least one single intravenous injection of the IMP followed by a total body PET/CT prior to receiving standard-of-care therapy.
15762285|NCT04758650|Drug|68GaNOTA-Anti-MMR-VHH2|An optional injection of the IMP during or after therapy can be administered if a patient is treated with non-surgical modalities.
15762286|NCT04758637|Behavioral|Overdose Notification|We will identify overdoses from state vital records and insurance claims data linked to emergency departments. We will use electronic health record data to identify prescriptions of scheduled drug to patients who experienced a non-fatal or fatal overdose within the health system. If randomized to the overdose notification group, physicians who prescribed the controlled substances to the deceased or surviving patient in the year prior to their overdose will be informed of the overdose via letter. The letters will alert prescribers to the patient's opioid-related overdose, recommend the use of the state-level PDMP, and list evidence-based interventions to lower opioid-related overdoses. The letters will increase the salience and availability of opioid-related harms, which may cause clinicians to be more wary of a future overdose when prescribing opioids, benzodiazepines, muscle relaxants, or sedative-hypnotics.
15762287|NCT04758624|Device|Deep Brain Stimulation|Medtronic Activa device will be implanted and administered clinically, except as part of the trial after 24 months of DBS being on it will be turned off for 3 days and will be turned back on.
15762288|NCT04758611|Device|eShunt™ Implant|The eShunt™ Implant is designed to drain excess cerebrospinal fluid (CSF) from the intracranial subarachnoid space (SAS) into the venous system as a minimally invasive treatment for communicating hydrocephalus.
15762289|NCT04758598|Device|Direct Selective Laser Trabeculoplasty (DSLT)|DSLT employs frequency-doubled, Q-switched Nd:YAG laser with a wavelength of 532 nm. During the procedure, a laser beam targets the trabecular meshwork (TM) - to improve intraocular fluid outflow. The laser beam is delivered in short nanosecond pulses and the selective cellular effect occurs at the pigmented cells of the TM. This increases the permeability of the TM endothelial cells and thereby increases outflow, resulting in reductions in IOP. In contrast to SLT, the DSLT treatment directs the laser beam directly through the sclera around the limbus without the need for a delivery device (gonioscope lens). Laser treatment lasts for about 2 seconds with about 120 laser shots delivered to the sclera around the limbus.
15762315|NCT04758390|Behavioral|Health promotion control group|The health promotion control intervention is a family-based intervention previously delivered to families in SA and translated into isiXhosa. The intervention promotes healthy living by encouraging good nutrition, exercise, and violence reduction. It will be delivered in the same format as IMARA and will be identical in length and intensity.
15762316|NCT04758377|Procedure|Magnetic resonance imaging (MRI)|Serial MRI scans of patients with acute cervical SCI to quantify hemorrhage.
15762317|NCT04758364|Other|measurement of gait speed|Cross sectional, cohort
15762290|NCT04758598|Device|Selective Laser Trabeculoplasty (SLT)|SLT employs frequency doubled Q switched Nd:YAG laser with a wavelength of 532 nm. It is delivered in short nano second pulses and the resulting selective effect to the pigmented cells of the TM, leaving the surrounding non-pigmented cells unaffected. This increases the permeability of the TM endothelial cells and can assist in increasing outflow and hence result in reductions in IOP. The procedure lasts approximately 10 minutes, with delivering 100 separate laser beams through a manually rotated mirrored lens (gonioscope), involving prolonged contact with the participant's eye. This treatment is applied on the cornea through a gonioscopic lens which is used to direct the laser beam to the desired location - the TM (360 degrees of treatment area).
15762291|NCT04758585|Procedure|Arthroscopy|Shoulder Arthroscopy
15762292|NCT04758572|Other|Manual Therapy|Mobilization, massage and stretching
15762293|NCT04758572|Other|Placebo massage|Kneading and rubbing without intention to treat
15762294|NCT04758559|Other|myfood24|An app to support monitoring of food and nutrient intake using robust validated methodology.
15762295|NCT04758559|Other|usual care|Patients will receive standard advice as provided by the clinical team, this may or may not include nutrition.
15762296|NCT04758546|Diagnostic Test|Screening criteria for weaning and minimal ventilatory settings for spontaneous breathing trial|Aggressive screening criteria: Walsh Conservative screening criteria: Boles High minimal ventilatory settings: pressure Support 8 + positive end-expiratory pressure 5 Low minimal ventilatory settings: pressure support 5
15762297|NCT04758533|Biological|AloCELYVIR|Mesenchymal allogenic cells + ICOVIR-5: 500.000 cells/kg
15762298|NCT04758520|Device|FLOAT upper limb exoskeleton|The FLOAT device is composed by a wearable exoskeleton assembled on a poly-articulated arm that, in turn, is mounted on a support base with unlockable wheels. The exoskeleton includes 5 motors arranged in a way that, when generating movement, ensures the optimal involvement of all the articulations of the shoulder complex, particularly the glenohumeral and the scapulothoracic joints. According to the chosen modality of use of the exoskeleton, the device allows patient's passive or active-assisted mobilization. The poly-articulated arm supporting the exoskeleton is capable to compensate exoskeleton weight in every configuration and, if configured appropriately, permits exoskeleton use both in seated and standing positions. The support base of the device has unlockable wheels that, if unlocked, permit the free movement of the patient in the workspace, enabling the performance of more complex functional activities while assisted by the exoskeleton.
15762299|NCT04758507|Biological|donor FMT|This intervention is represented by the administration, in the recipients' gut, of donor microbiota through FMT
15762300|NCT04758507|Other|Placebo FMT|This intervention is represented by the administration, in the recipients' gut, of a placebo through FMT
15762301|NCT04758494|Other|Questionnaire|"In the present study a questionnaire was designed by combining three separate questionnaires, which were weighted for use in Greek population and which are often being used to investigate quality of life of young populations diagnosed with stroke or multiple sclerosis, according to international literature. Those were the following questionnaires: Bathrel (Mahoney et al), Patient Health Questionairre (PHQ-9) (Thomson K et al), Health Survey SF-12 (Kontodinopoulos et al 2007). A draft questionnaire was then created with the addition of questions deemed necessary to provide necessary research information. Overall the questionnaire consisted of 42 questions.
~Part A The first part of the questionnaire included demographics of participants. Part B. The second part of the questionnaire included an assessment of the functionality and independence, an evaluation of experienced depression and an assessment of the quality of life of the target population."
15762302|NCT04758481|Radiation|primary tumour radiotherapy|The study subjects will undergo primary tumour radiotherapy.
15762303|NCT04758481|Radiation|stereotactic body radiotherapy|The study subjects will undergo stereotactic body radiotherapy.
15762304|NCT04758481|Radiation|maintenance radiotherapy|The study subjects will undergo maintenance radiotherapy.
15762305|NCT04758468|Behavioral|Telerehabilitation-based pelvic floor muscle training|"Telerehabilitation-based pelvic floor muscle training group will individually receive telerehabilitation-based pelvic floor muscle training under the guidance of a physiotherapist 2 sessions per week for 8 weeks. Participants will do their exercises themselves 2 times on the days where sessions are held with a physiotherapist. Participants will continue to exercise 3 times a day in the remaining days.
~Both intervention groups will follow the same pelvic floor muscle training protocol for 8 weeks."
15762306|NCT04758468|Behavioral|Home-based pelvic floor muscle training|"The home-based pelvic floor muscle training group will do their individual exercises 3 times a day for 8 weeks.
~Both intervention groups will follow the same pelvic floor muscle training protocol for 8 weeks."
15762307|NCT04758455|Diagnostic Test|P53, Ki67 and Cyclin A IHC.|P53, Ki67 and Cyclin A immunohistochemical staining of formalin-fixed paraffin-embedded specimens of Wilms' tumour.
15762308|NCT04758442|Other|Additional blood sample|Included subjects will provided three blood samples to follow vancomycin concentration
15762309|NCT04758429|Device|Machine-learning Algorithm|System technology/Software
15762310|NCT04758416|Procedure|biopsy or surgical pathology in metastases|biopsy or surgical pathology in extrahepatic/liver/brain metastases
15762311|NCT04758416|Drug|68Ga-HER2 affibody,18F-FDG, 18F-FES|68Ga-NOTA-MAL-MZHER2 (68Ga-HER2) affibody is an investigational Positron Emission Tomography (PET)/ Computed Tomography (CT) radiopharmaceutical.
15762312|NCT04758403|Radiation|Navigation Bronchoscopy|Navigation Bronchoscopy procedure will be performed per product instructions and the institution's standard practice.
15762313|NCT04758403|Radiation|Cone beam computed tomography (CBCT)|Per Protocol
15762314|NCT04758390|Behavioral|IMARA (intervention group)|The IMARA intervention aligns with an ecological framework, emphasizing the intersection of individual, social, and structural determinants of women's sexual health and behavior. Separate FC and AGYW groups run simultaneously and cover parallel content, while joint activities enhance FC credibility as a resource for HIV/STI prevention and facilitate practice of communication skills. Interventionists use interactive and experiential activities. IMARA's goals and motto emphasize strong FC-AGYW relationships, sisterhood, community empowerment, and motivation for HIV prevention, and build group cohesion. FC and AGYW sign a pact to confirm commitment to the program. At the end of Workshop Day 1, participants receive homework to complete during the week. Woven throughout IMARA is the impact of mental health issues, alcohol and drug use, and violence on HIV-risk.
15762318|NCT04758351|Other|Usual clinical practice|Based on European Respiratory Society guidelines on management for chronic cough.
15762319|NCT04758338|Other|VUMC telehealth services|Participants will access the CTS link (sent to them via email), which will connect them directly to a videoconference and enable them to see and hear the facilitators and other patients in the group.
15762320|NCT04758338|Other|Interview|25-30 participants will be interviewed
15762321|NCT04758338|Other|Educational materials|Participants will be provided educational materials
15762322|NCT04758312|Behavioral|MY-Skills Mobile|Yoga and Self-Management Education
15762323|NCT04758299|Other|decision science-based design|decision science-based design explaining actions to take for a negative or positive COVID-19 test
15762324|NCT04758286|Procedure|Emergency surgical procedures|COVID-19 patients who had presented to the Emergency Department were evaluated for their emergency surgical conditions and were managed appropriately
15762325|NCT04758273|Biological|medium dosage inactivated SARS-CoV-2 vaccine|medium dosage
15762326|NCT04758273|Biological|high dosage inactivated SARS-CoV-2 vaccine|high dosage
15762327|NCT04758273|Biological|Placebo|placebo
15762328|NCT04758260|Dietary Supplement|Antioxidant|Oral antioxidant oral intake in the 3 months prior to inclusion in the study
15762329|NCT04758247|Device|TheraNova Neuromodulation System|The investigational device is a transcutaneous electrical nerve stimulation (TENS) device that is designed to provide stimulation to the nerves at the site of application via surface electrodes temporarily adhered to the skin.
15762330|NCT04758234|Drug|LY3549492|Administered orally.
15762331|NCT04758234|Drug|Placebo|Administered orally.
15762332|NCT04758221|Other|Treatment by composite coronal build-up|A total of (42) decayed or traumatized primary anterior teeth were treated with composite coronal build-up based on the micromechanical adhesive procedure of composite resin in addition to macro mechanical retentive grooves created on the lateral sides of the cervical one third of the roots of treated teeth.
15762333|NCT04758208|Diagnostic Test|Hematology Parameters|Measurement of hematology parameters on BC-6800Plus
15762334|NCT04758195|Procedure|Transanal irrigation|Transanal irrigation (TAI) is performed using the irrigation bag, electronic irrigation system, or balloon catheter with syringe. TAI is performed with up to 2000 ml tap water every 24-48 hours (3-7 times per week) over the course of 6 months.
15762335|NCT04758195|Other|Best supportive therapy|Best supportive therapy consists of dietary modification, pelvic floor muscle training, biofeedback, and necessary medication.
15762336|NCT04758182|Device|High intensity laser therapy|Device: HIRO 3.0 device high peak power (3kW), a wavelength of 1064 nm
15762337|NCT04758182|Device|Ultrasound therapy|Device: Chattanooga intellect mobile ultrasound device frequency of 1 MHz, an intensity of 2 W/cm2 and a duty cycle of 100%
15762338|NCT04758169|Other|Enhanced Homestead Food Production|Enhanced Homestead Food Production program will provide increased production and consumption of nutrient rich foods, increased income of the households through the sale of surplus produce, and increased self-efficacy and decision making by adolescents due to increased knowledge and skills- resulting increased food security and nutrition and ultimately delay of child marriage.
15762339|NCT04758169|Other|Control|Control group will only receive parental awareness sessions, community awareness-raising activities, adolescent group sessions involving awareness on the benefit of delayed marriage and empowerment, SRH, and basic life-skill trainings.
15762340|NCT04758156|Drug|CleanViewAL|1L PEG + ascorbic acid bowel preparation for colonoscopy
15762341|NCT04758156|Drug|SUPREP|Oral sulfate solution for colonoscopy bowel preparation
15762342|NCT04758130|Other|Zamplo Digital Health Platform|This application will be provided to patients and provide them with a method to track various data related to their metabolic disease.
15762343|NCT04758104|Radiation|Yttrium90|Intracystic implantation of 90yttrium colloid
15762344|NCT04758078|Other|Inhaled corticosteroids|Budesonide 2 mL = 1000 microgram will be given within 6 hours of birth and the second dose will be given after 12 hours
15762345|NCT04758078|Other|Placebo|Nebulized 0.9% saline will be given four times per day
15762346|NCT04758065|Other|Radial pressure waves Therapy|"Combination of the usual physiotherapy treatment with the application of radial pressure waves compared with a control group in which only the usual treatment, in people with non-specific neck pain, will be applied.
~During the first month, the participants will perform 3 weekly sessions of home-based cervical therapeutic exercise and will come to the facilities, once a week, to get a manual therapy session based on the Maitland Concept (15 minutes of posteroanterior mobilizations in the restricted and/or painful vertebrae of the cervical and thoracic spine). Besides this participants of the experimental group will receive a radial pressure waves treatment sessión.
~Experimental Group: Home-based cervical therapeutic exercise, manual therapy, and radial pressure waves."
15762347|NCT04758065|Other|Therapeutic Exercise and Manual Therapy|"Combination of the usual physiotherapy treatment with the application of radial pressure waves compared with a control group in which only the usual treatment, in people with non-specific neck pain, will be applied.
~During the first month, the participants will perform 3 weekly sessions of home-based cervical therapeutic exercise and will come to the facilities, once a week, to get a manual therapy session based on the Maitland Concept (15 minutes of posteroanterior mobilizations in the restricted and/or painful vertebrae of the cervical and thoracic spine). Besides this participants of the experimental group will receive a radial pressure waves treatment sessión.
~Control Group: Home-based cervical therapeutic exercise and manual therapy."
15762348|NCT04758052|Other|Timing of placement|Simultaneous placement of tracheostomy and gastrostomy
15762349|NCT04758013|Procedure|Epidural injection through thoracic epidural catheter|The investigators inject drugs through a catheter inserted into the thoracic epidural space to control pain after surgery in patients undergoing gastric surgery by laparoscopy.
15762350|NCT04758013|Procedure|Without epidural injection|The investigators don't epidural injection to find out the effect of only inter-abdominal pressure on intracranial pressure.
15762351|NCT04758000|Drug|Metformin Hydrochloride|"Metformin will be administrated according with patients body mass index (BMI).
~Patients between 14 and 18 years old or with BMI ≤ 20: 500 mg two times a day Patients older than 18 years or with BMI > 20: 850 mg two times a day.
~In all cases, metformin will be administrated for 3 years maximum, unless there is a progression disease or if toxicity is verified."
15762352|NCT04757987|Other|Pain|As above
15762353|NCT04757974|Drug|Fostemsavir 600 mg|Fostemsavir tablets will be administered via oral route.
15762354|NCT04757974|Drug|Fostemsavir 200 mg|Fostemsavir tablets will be administered via oral route.
15762355|NCT04757961|Behavioral|LifeStories|The content of LifeStories is divided thematically into core ACT concepts across the four episodes as follows: 1) cultivating awareness of the transient nature of mood experiences and the benefit of trying out various strategies to cope with depression when it arises; 2) clarifying one's own values and setting personal goals related to these values; 3) developing a more accepting and nonjudgmental stance towards difficult thoughts and feelings and practicing self-compassion;and 4) living more mindfully in the present moment.
15762356|NCT04757948|Procedure|Acupuncture|Acupuncture of acupoints P-6 and St-36
15762357|NCT04757948|Device|TENS|TENS of acupoints P-6 and St-36
15762358|NCT04757948|Device|Sham-TENS|Sham-TENS of acupoints P-6 and St-36
15762359|NCT04757935|Behavioral|Yoga|Yoga for 30 minutes three times weekly for 8 weeks in addition to three, 1-hour in-studio yoga sessions.
15762360|NCT04757922|Procedure|Opportunistic salpingectomy / bilateral salpingectomy|An opportunistic salpingectomy refers to removal of the salpinges without the ovaries during (laparoscopic) interventions for benign (gynaecological) disease to reduce the number of ovarian cancer cases. Therefore, a so-called opportunistic salpingectomy is a method of female sterilization.
15762361|NCT04757909|Diagnostic Test|Monthly Haemoglobinometry|"Monthly measurement of capillary hemoglobin with non-invasive techniques in primary health care.
~Inclusion in a transfusion circuit with referral to a hospital day hospital if necessary."
15762362|NCT04757896|Procedure|Lateral costoclavicular approach|USG guided lateral costoclavicular approach for brachial plexus block
15762363|NCT04757896|Procedure|Medial costoclavicular approach|USG guided medial costoclavicular approach for brachial plexus block
15762364|NCT04757883|Other|Study of the synthesis of antibodies directed against SARS|Between 5 mL and 45 mL of additional blood will be collected to study the synthesis of antibodies against CoV-2 SARS and to investigate whether specialised immune cells also show an effective response against the virus.
15762365|NCT04757870|Other|frequency|Macro-scale risk factors for the frequency of and mortality of infection
15762366|NCT04757857|Drug|Rivaroxaban 10 mg|Rivaroxaban pharmaceutical form will be tablets of 10 mg
15762367|NCT04757844|Device|Functional Near-Infrared Spectroscopy (fNIRS)|The hemodynamic response in prefrontal cortex will be measured using an Octamon+ system (Artinis). Eight emission and two detector probes will be arranged on the participant's forehead.
15762368|NCT04757818|Other|0.07% cetylpyridinium chloride (CPC) in mouthwash|A mouthwash and gargles with 15 ml of 0.07% cetylpyridinium chloride (CPC) in mouthwash for 1 minute.
15762369|NCT04757818|Other|Distilled water with the same colorant as the experimental product|A mouthwash and gargles with 15 ml of distilled water for 1 minute
15762370|NCT04757805|Diagnostic Test|Ultrasound|Ultrasound to locate the appropriate lumbar interspace to perform spinal anesthesia.
15762371|NCT04757792|Other|File inquiry|Data extraction out of file registry
15762372|NCT04757779|Drug|anlotinib hydrochloride combined with irinotecan or docetaxel|From the start of the study, the subjects are orally administered with anlotinib 12mg on empty stomach.Subjects need to take anlotinib 2 weeks continuously and stop for 1 week(every 3 weeks is a cycle),the dose of anlotinib can be adjusted as 12mg,10mg or 8mg according to adverse effects.On Day1 and Day8, subjects are required to inject irinotecan (65mg/m2)or docetaxel (60mg/m2) of a cycle,until disease progression or intolerable toxicity, for 4 cycles at most.
15762373|NCT04757766|Drug|in daily everyday routine practice|The treatment of patients with chronic venous disease of CEAP classes C6 will be consistent with routine clinical practice, local label for the medical use of drugs and the specific clinical situation.
15762374|NCT04757753|Device|ready-to-use root canal sealer: PA1704|The participant will be treated with the ready-to-use root canal sealer (PA1704) in combination with gutta percha.
15762375|NCT04757753|Device|root canal sealer: BioRoot™ RCS|The participant will be treated with BioRoot™ RCS sealer in combination with gutta percha.
15762376|NCT04757740|Biological|intra-articular Platelet rich fibrin and lidocaine|intra-articular injection of 3.5 ml of 1% lidocaine and PRF mixture.
15762377|NCT04757740|Drug|methylprednisolone acetate and lidocaine|intra-articular injection of Mixture of 40 mg of methylprednisolone acetate(1 ml) and 1% lidocaine (2.5 ml). intra-articular steroid
15762378|NCT04757727|Other|Decriptive study of EDB|data on EDB will be register
15762379|NCT04757714|Procedure|The high-resolution peripheral scanner (HRpQCT) of the tibia and radius|The high-resolution peripheral scanner (HRpQCT) of the tibia and radius
15762380|NCT04757714|Procedure|a low-dose imaging system exploration of their thoraco-lumbar spine (EOS system)|a low-dose imaging system exploration of their thoraco-lumbar spine (EOS system)
15762381|NCT04757714|Other|Questionnaires|"a physical activity questionnaire (PHAS instrument)
~a COPD quality of life questionnaire (St George Hospital)"
15762382|NCT04757714|Other|A search for sarcopenia by studying the strength of the grip (dynamometer)|A search for sarcopenia by studying the strength of the grip (dynamometer)
15762383|NCT04757701|Other|Social Behavioral surveys, interviews, and focus groups|Surveys with dentists/hygienists, interviews/focus groups with service learning center directors and key staff at federally qualified health centers.
15762384|NCT04757688|Radiation|Cardiac radioablation (CRA)|CRA to 25 Gy in 1 fraction
15762385|NCT04757675|Drug|S-ketamine 0.3|0.3 μg/kg intravenous injection s-ketamin
15762386|NCT04757675|Drug|S-ketamine 0.5|0.5 μg/kg intravenous injection s-ketamin
15762387|NCT04757675|Drug|S-ketamine 2|2 μg/kg intranasal s-ketamin
15762388|NCT04757675|Drug|S-ketamine 1+Dexmedetomidine 1|1 μg/kg intranasal s-ketamin + 1 μg/kg intranasal dexmedetomidine
15762389|NCT04757675|Drug|S-ketamine 0.5 +Dexmedetomidine 2|0.5 μg/kg intranasal s-ketamin + 2 μg/kg intranasal dexmedetomidine
15762390|NCT04757662|Drug|Tadalafil|Tadalafil is commercially available and will be purchased by the Siteman Cancer Center and distributed to participants free of charge.
15762481|NCT04756765|Drug|Talazoparib Tosylate|Talazoparib1 mg/day is to be administered orally on a continuous dosing schedule.
15762482|NCT04756752|Other|Fit and Vitaal program|Intervention type: training
15762483|NCT04756739|Device|Clearblue Connected Ovulation Test System|Clearblue Connected Ovulation Test System which is a CE marked device used for tracking the menstrual cycle
15762484|NCT04756726|Drug|CFT7455|oral CFT7455 QD for 21 days of a 28-day cycle
15762395|NCT04757623|Procedure|Purse string closure of Ileostomy|conventional proceedure
15762399|NCT04757597|Device|Remote ischemic conditioning|RIC is a non-invasive therapy that performed by an electric autocontrol device with cuff placed on arm. RIC procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on one arm. The procedure will be performed once daily for consecutive 10-14 days after enrollment.
15762400|NCT04757584|Drug|Beta blockers|"The intervention is a two-arm crossover withdrawal/ reversal design (On [A] vs Off [B]) with 4 periods, each period lasting up to 6 weeks. During the On period (A), subjects will be on their beta blocker. During the Off period (B), their beta blockers will be down titrated and subsequently discontinued.
~Subjects will be randomized into either ABAB or BABA sequences."
15762401|NCT04757571|Drug|Paroxetine|Paroxetine 20 mg tablet plus standard therapy
15762402|NCT04757571|Drug|Placebo|Placebo tablet plus standard therapy
15762403|NCT04757558|Device|C-MAC video-stylet|Patients will be randomly assigned two group 40 patients each, C-MAC-VS group (VS group) (Karl Storz GmbHand Co.KG, Germany), and control group (C group). This will be done using a closed envelope technique using a computer-generated block randomization method.
15762404|NCT04757558|Device|Macintosh laryngoscope|Patients will be randomly assigned two group 40 patients each, C-MAC-VS group (VS group) (Karl Storz GmbHand Co.KG, Germany), and control group (C group). This will be done using a closed envelope technique using a computer-generated block randomization method.
15762405|NCT04757545|Other|HM-PRO|"The intervention group will have a predetermined consultation appointment planned to assess medical status and symptom control. Seven days prior to the scheduled visit, the patient will receive an electronic invitation via RedCap to complete and send PRO data (HM-PRO). Prior to each appointment PRO data will be evaluated by a nurse from an algorithm deciding one of three tracks for the patients:
~Worsening in symptoms results in a nurse-led telephone consultation within two days guided by the symptom management manual.
~Minor changes in patient's symptom assessment result in a nurse-led telephone consultation within seven days using the symptom management manual.
~Patients that are completely stable in the symptom assessment will receive an electronic answer via min-SP (electronic patient journal) regarding the results and a new appointment, including PRO-data prior to this."
15762406|NCT04757532|Drug|Bupropion|300 mg of bupropion hydrochloride (1 tablet) administered orally in a single dose.
15762407|NCT04757532|Drug|Anastrozole|1 mg of anastrozole (1 tablet) administered orally in a single dose.
15762408|NCT04757532|Drug|Testosterone cyclopentylpropionate|100 mg of testosterone cyclopentylpropionate (equivalent to 70 mg of testosterone) administered via intramuscular injection in a single dose (2 mL).
15762409|NCT04757532|Drug|Danazol|200 mg of danazol (1 capsule) administered orally in a single dose.
15762410|NCT04757532|Drug|Chlorthalidone|50 mg of chlorthalidone (1 tablet) administered orally in a single dose.
15762411|NCT04757519|Behavioral|DPP-GLB Standard|The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer.
15762412|NCT04757519|Behavioral|DPP-GLB Enhanced|The intervention is based upon the 2017 version of the University of Pittsburgh DPP Group Lifestyle Balance Program (DPP-GLB). Participants will receive the DPP-GLB intervention once per week for 12 weeks, then twice monthly for 12 weeks (18 sessions total). The program includes hour-long group-based sessions and supportive materials including a weekly food diary and FitBit/pedometer. Intervention week 4, weight loss non-responders defined as weight loss less than 1% receive weekly telephone intervention, using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Additionally, this intervention includes weekly phone calls using motivational interviewing techniques to provide social support, assess barriers, resolve ambivalence, and support the participant in developing personal strategies. Links to relevant videos may also be provided.
15762413|NCT04757506|Drug|Naltrexone|opioid receptor antagonist
15762414|NCT04757506|Drug|Placebo|
15762416|NCT04757480|Procedure|Thoracolumbar Interfascial Plane Block (TLIP)|(20ml) (plain bupivacaine 0.25% on each side toward the LG-MF interface.
15762417|NCT04757480|Procedure|Bilateral Erector Spinae plane Block (ESB)|Will receive (20ml) (plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath) at the level of the eighth thoracic segment (T8).
15762418|NCT04757467|Other|Standard physiotherapy neuro-rehabilitation|Treatment interventions which will be used for this group Passive range of movement exercises. Therapeutic positioning of the lower limb. Strengthening exercise for the lower limb. Over-ground gait training 5 times a week for 4 weeks. First week= 30 min exercise Second week= 1hour exercise Third week= 1hour and 30 min exercise Fourth week= 2 hours exercise All the treatment protocols will be applied to the patient for 5 times a week for consecutive 4 weeks. Interventions will be performed in the clinic and through home-based exercises using patient education
15762419|NCT04757467|Other|Repetition-CIMT|"In this group of patients, the CIMT technique will be used for treatment. Following tasks will be performed by the patient, the unaffected limb will be constrained using a tight knee brace for about3 hr.
~Sit-to-Stand
~Forward and Backward stepping
~Stair Climbing and Descending (only the first stair will be used)
~Side-to-Side stepping with the affected limb
~Each task will be performed 10 times per session in the first week and 2 sessions a day. In the second week, each task will be performed 20 times per session for 2 sessions a day. In the third week, each task will be performed 30 times per session for 2 sessions a day.In the fourth week, each task will be performed 40 times per session for 2 sessions a day. The session will be held 5 days in a week for the period of consecutive 4 weeks. Total of 1000 repetitions of the above mentions tasks will be performed in 4 weeks' study time by every participant"
15762420|NCT04757467|Other|Hour-CIMT|A task that performed by the participants in this group will be the same as performed by the rep-CIMT group. The unaffected limb will be in constrained for 3 hours. (15) Sessions will be held 5 days in the week for a period of consecutive 4 weeks.
15762421|NCT04757454|Diagnostic Test|5-item SARC-F questionnaire|Administration of the 5-item SARC-F questionnaire in patients admitted to an acute care unit
15762422|NCT04757441|Other|Group A: Conventional Treatment + Elongation Longitudinaux Decoaption of Osteo-Articulaire|"ELDOA position for L5, S1 level Patient will ask to lie on his back, wedge buttocks in the corner of wall and raise his legs. Then Stretch the legs and push the heels toward ceiling. Extend the spine and stretch the arms above head .
~• Patient will hold this position for one minute and repeat it for 4 -5 times.
~Conventional treatment will include:
~Hot pack for 15 minutes .
~TENS for 10 minutes .
~self stretching of hamstrings"
15762423|NCT04757441|Other|Group B: Conventional treatment|"Participants will receive only conventional treatment which will include:
~Hot pack for 15 minutes .
~TENS for 10 minutes .
~self stretching of hamstrings"
15762424|NCT04757428|Procedure|Endocrown|Endocrown
15762425|NCT04757415|Other|Traction straight leg raise technique for hamstring|traction straight leg raise technique is used along with gluteal exercises
15762426|NCT04757415|Other|Gluteal activation exercises,Hotpack|only gluteal activation exercises were performed without traction straight leg raise technique
15762427|NCT04757402|Other|Counselling with NSQIP Surgical risk calculator|Use of NSQIP surgical risk calculator to check for patient satisfaction regarding pre operative counseling.
15762428|NCT04757376|Biological|CT-P41|60 mg/mL single dose, Solution for injection in PFS
15762429|NCT04757376|Biological|US-licensed Prolia|60 mg/mL single dose, Solution for injection in PFS
15762430|NCT04757363|Drug|regorafenib|regorafenib (80 mg on days 1-21 of the 28-day cycle)
15762431|NCT04757363|Drug|nivolumab|nivolumab (240 mg on days 1 and 15 of the 28-day cycle).
15762432|NCT04757363|Drug|FOLFOX chemotherapy with oxaliplatin|FOLFOX chemotherapy with oxaliplatin (85 mg/m2 IV), leucovorin (400 mg/m2 IV), 5-FU (400 mg/m2 IV bolus), and 5-FU (2400 mg/m2/day continuous IV infusion over 48 h).
15762433|NCT04757350|Other|Observational research, not applicable|Observational research, not applicable
15762434|NCT04757337|Drug|Doxorubicin|6 x 3-week cycles corresponding to a maximal duration of 18 weeks
15762435|NCT04757337|Drug|Cyclophosphamide|Until progression up to 24 months
15762436|NCT04757324|Other|breastfeeding education|
15762437|NCT04757298|Behavioral|Navigation Services|Navigation services include assessment and support with service referrals. Each participant will meet with a peer navigator in person or on Zoom Conferencing for 30 minutes to go over results from their social and health needs assessment that is retrieved from the baseline assessment. The navigator shares information about COVID-19, answers questions about testing, and makes referrals to other needed services
15762438|NCT04757298|Behavioral|Critical Dialogue|Critical Dialogue includes three one-hour-long, open-group-sessions facilitated in person or online by a trained licensed facilitator. Group critical dialogue is prompted by thematic images developed by the NCCB to foster a deeper understanding of how systematic stigma, feelings of rage as victims of discrimination, and/or apathy may impact participants' beliefs and behaviors related to COVID-19 and empower participants to make critical choices to protect their health and the health of their communities.
15762439|NCT04757298|Behavioral|Brief Counseling|Brief Counseling is a 15-minute post-COVID-19 test session delivered by a trained licensed clinician in person or via Zoom Conferencing. In the session, the clinician shares the test results and offers recommendations and information about COVID-19 treatment and prevention.
15762440|NCT04757298|Behavioral|Referral and Digital Brochure|Referral will consist of a five-minute phone call where an outreach worker offers participants information about COVID-19 testing and encourages them to get tested within one week. A digital brochure containing NJ recommendations is e-mailed or texted to participants.
15762441|NCT04757259|Drug|cerdulatinib|Participants will receive oral cerdulatinib at the starting dose he or she was receiving at completion of Study 13-601 (30, 25, 20, or 15 milligrams [mg] twice daily [BID]).
15762442|NCT04757246|Other|MouthLab Device|Use of MouthLab system
15762443|NCT04757233|Behavioral|GlucoType|GlucoType is an mobile Health intervention for facilitating self-management in T2DM built for iPhone and Android smartphones. GlucoType includes a custom-built interface for low-burden capture of diet and blood glucose (BG) levels and relies on a commercial activity tracker, FitBit, for capture of sleep and physical activity. It then applies computational phenotyping techniques to identify patterns of associations between daily activities and changes in BG levels. GlucoType uses an expert system developed by our research team to translate identified phenotypes into automatically-generated personalized behavioral goals for improving glycemic control formulated in natural language.
15762444|NCT04757220|Other|Cognitive tasks with EEG recording|questionnaires and cognitives tasks
15762445|NCT04757207|Other|survey|International Physical Activity Questionnaire (short form)
15762446|NCT04757194|Diagnostic Test|openTriage - Alitis algorithm|A machine learning algorithm (Gradient boosting) applied to structured data collected in the Alitis Clinical Decision Support system, patient demographics, and free-text notes.
15762485|NCT04756726|Drug|Dexamethasone Oral|oral dexamethasone [ ≤75 years old: 40 mg once per week (QW) on days 1, 8, 15, and 22; >75 Years old: 20 mg QW on days 1, 8, 15, and 22]
15762486|NCT04756713|Procedure|Uterine curettage|Manual or electric vacuum aspiration under ultrasound guidance.
15762447|NCT04757181|Other|The IBD-AID|Subjects will meet with study personnel for to fill out baseline questionnaires (approximately a 1-hour visit). Subjects will be instructed to make dietary changes based one the IBD-AID guidelines. Dietary instruction will be delivered via individual and group sessions led by trained study personnel. Participants will be expected to learn the skills of dietary change to the IBD-AID and will begin their 8 weeks compliance period followed by endpoint measures. Participants are encouraged to attend 3 cooking classes (1.5 hours duration) in our teaching kitchen.
15762448|NCT04757168|Device|NOGA TM probe|"Each subject will be his own witness since the linear local shortening (LLS) will be measured successively in all patients before, then after stimulation of the scar zone (comparison of LLS measured in sinus rhythm then during stimulation in the scar zone for each patient.
~Each subject being his own witness and the two recordings being made a few minutes apart, during the same procedure."
15762449|NCT04757155|Behavioral|Internet Adaptation of Managing Cancer and Living Meaningfully (iCALM)|A online psychotherapy designed for patients with advanced and metastatic cancer.
15762450|NCT04757116|Device|iTind|The iTind is implemented for 5-7 days
15762451|NCT04757116|Procedure|TURP|TURP is a surgical procedure which removes prostatic tissue by electrocautery dissection
15762452|NCT04757103|Procedure|Resection of the retrorectal tumor|Surgical resection of the retrorectal mass
15762453|NCT04757090|Drug|89Zr-trastuzumab|"-To minimize uptake of the 89Zr-trastuzumab in normal tissues, immediately prior to planned 89Zr-trastuzumab injection patients will receive a 50 mg dose of cold unlabeled trastuzumab intravenously (IV). The administration of a fixed small dose of unlabeled antibody to improve tumor-to-normal-tissue (T/N) uptake of the radiolabeled antibody is standard in this type of imaging procedure."
15762454|NCT04757064|Other|standard rehabilitation protocol|they will receive knee flexion exercises and increase the extensor strength
15762455|NCT04757038|Device|Intradiscal injection|The injection will be administered at V1 baseline (day 0). Any physical activity (e.g. jogging, tennis, weightlifting, prolonged upright position) in the 48 hours following the injection should be avoided.
15762456|NCT04757025|Device|Electrical Impedance Tomography|In 27 patients ventilation will be guided with an Electrical Impedance Tomography system
15762457|NCT04757025|Device|Peripheral arterial Saturation|The ventilation of 27 patients will be guided by Peripheral arterial Saturation alone
15762458|NCT04757012|Device|calinange|calinange
15762459|NCT04756999|Behavioral|massage therapy|Reflexology is massage therapy used to maintain and improve health, as well as relieve some symptoms.
15762460|NCT04756986|Drug|malic acid|1% malic acid spray
15762461|NCT04756973|Behavioral|Behavioral weight loss program|A 12 week small group weight loss program delivered via teleconference video technology
15762462|NCT04756960|Drug|CHF6001|4 inhalations of CHF6001 800µg/20mg NEXThaler® DPI (total dose of 3200µg) co-administered with an intravenous microdose (18.5µg (18.5kBq)) of [14C]-labelled CHF6001
15762463|NCT04756947|Procedure|surgical treatment according to standard indication criteria|internal fixation according to standard indication criteria
15762464|NCT04756947|Procedure|conservative treatment according to standard indication criteria|conservative therapy according to standard indication criteria
15762465|NCT04756934|Drug|HX008|HX008: 200mg, Q3W
15762466|NCT04756934|Drug|LP002|LP002: 1mg/kg, or 3mg/kg, or 5mg/kg, Q3W
15762467|NCT04756921|Drug|Pyrotinib|Pyrotinib 400mg po qd
15762468|NCT04756908|Device|Cataract Surgery|The surgical procedure in which the natural crystalline lens is removed and replaced with a lens implant.
15762469|NCT04756895|Other|Vancomycin dose adjustment using the Bayesian method|This intervention is the experimental method. The AUC/MIC target is 400-600 mg*hour/L.
15762470|NCT04756895|Other|Vancomycin dose adjustment using the trough level method|This intervention is the standard method. Previous clinical guidelines recommended this method. The trough target is 10-15 mg/L for non-severe infections and 15-20 mg/L for severe infections.
15762471|NCT04756882|Drug|AbobotulinumtoxinA 500 UNT|"Anaerobic fermentation of the bacterium Clostridium botulinum produces botulinum toxin. A range of different C. Botulinum strains have been recognized; eight immunologically different serotypes (type A-H) are created and consist of botulinum neurotoxin complexed with a number of related proteins.
~Neurotoxin type A preparations are the most widely used for therapeutic application. There are currently three leading botulinum neurotoxin type A (BoNT/A) products on the market in the Western Hemisphere: onabotulinumtoxinA (ONA; Botox/Vistabel, Allergan Inc., Irvine, CA, USA), abobotulinum toxin A (ABO; Dysport/Ipsen Limited, Slough Berkshire, UK), and incobotulinum toxin A (INCO; Xeomin/Bocouture, Merz Pharmaceuticals GmbH, Frankfurt, Germany). In nature, BoNT-A is synthesized as macromolecular protein complexes"
15762472|NCT04756869|Other|COVID-19 Monitoring Using Wearable Sensors and Smartphone Technology|Health care workers are on-study for 30 days, in which they wear a smart watch and temperature patches up to daily. Subjects also may provide nasal and saliva samples up to daily during the study period, and they may opt-in to blood samples lasting up to 1 year after study completion. Through a smartphone app, participants complete surveys at baseline and at study completion, as well as daily mood surveys and symptom-reporting surveys. Finally, exit interviews occur at the end of the study period, and follow-up interviews may occur at specified timepoints up to 1 year after study completion.
15762473|NCT04756856|Other|Muscle-target oral nutritional supplementation|Patients will receive daily for 12 weeks two servings (40 grams each) of powder (Fortifit; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, and 800 IU vitamin D. Patients will be also followed for 12 weeks after the suspension of supplementation.
15762474|NCT04756843|Device|Quad-helix|Fixed orthodontic appliances
15762475|NCT04756830|Biological|Adsorbed COVID-19 (inactivated) Vaccine|Participants will receive two doses with 14-days interval of adsorbed COVID-19 (inactivated) vaccine
15762476|NCT04756804|Drug|70% v/v Isopropyl Alcohol Surgical Solution|Patient preoperative skin preparation
15762477|NCT04756804|Drug|2%w/v Chlorhexidine Gluconate / 70% v/v Isopropyl Alcohol|Patient preoperative skin preparation
15762478|NCT04756791|Procedure|SAPB|local anesthetic is injected between the serratus anterior and latissimus dorsi muscles.
15762479|NCT04756791|Procedure|Local Injection Anesthesia|Anesthesia is injected directly into the tissue that is will be numbing.
15762480|NCT04756778|Procedure|Aortic surgery +/- aortic valve replacement|Replacement of aneurysmal proximal thoracic aorta +/- replacement of diseased bicuspid aortic valve
15762487|NCT04756713|Drug|Chemotherapy|conventional chemotherapy will be treated with MTX (1 mg/kg intramuscular) with rescue of FA (15mg orally). In cases of chemoresistance, second-line chemotherapy will be performed with actinomycin-D (Act-D) 1.25 mg intravenous pulse every 14 days. The third line of chemotherapy will be the EMA/CO regimen (, reserving the EP / EMA regimen (E, cisplatin, MTX / Act-D) for the fourth line.
15762488|NCT04756700|Diagnostic Test|DigiCog (BCCAMS app)|Administered as specified in the treatment arm.
15762489|NCT04756700|Diagnostic Test|Konectom Application|Administered as specified in the treatment arm.
15762491|NCT04756674|Other|No intervetion will be used|No intervention will be used
15762492|NCT04756661|Drug|Carbetocin|100 mcg of Carbetocin intravenous injection
15762493|NCT04756661|Drug|Oxytocin|10 IU oxytocin IV drip
15762494|NCT04756661|Drug|Misoprostol|400 mcg rectal
15762495|NCT04756648|Drug|CT0180 Cells|Five dose levels were tentatively determined.
15762496|NCT04756635|Other|Experimental Group|This 3-year project will include two groups of participants: 1) young men accustomed to resistance training (study #1) and 2) young men accustomed to endurance training (study #2). Inclusion will be limited to healthy participants (i.e. nonsmokers, normotensive with systolic and diastolic values <135/85 mmHg, non-obese, non-medicated, and free of any known disease as assessed by medical history) (Pickering, Hall et al. 2005). Month 1-3 will focus on literature review and month 4 to 8 will address experimental settings preparation and selection of participants to include in each study. Testing and data collection will be scheduled for months 9-14 and 13-18 (study # 1 and 2 related testing, respectively). Data processing, analysis and presentation will occur from month 21 to 33. All participants will read and sign an informed consent document with the description of the testing procedures. The Faculty's ethical committee will be asked to approve this document before testing.
15762497|NCT04756622|Drug|N acetyl cysteine|N acetyl cysteine dissolved in water at a dose of 600 mg three times daily from day of transplant until neutrophil engraftment, or upon resolution of OM, whichever appears later.
15762498|NCT04756609|Procedure|Systematic offer of nurse-driven SARS-CoV-2 screening combined with usual practice|"I- A SARS-CoV2 self-administered questionnaire about SARS-CoV2 symptoms, possibilities of close contacts, risk exposure situations and socio-demographic characteristics will be offered to patients included who are capable of filling it out.
~The patient will fill out the questionnaire and hand it in to the nurse caring for him/her.
~The nurse, regardless of the answers to the questionnaire, will offer the SARS-CoV2 screening.
~A nasopharyngeal swab for SARS-CoV2 will be carried out.
~A patient will be considered as symptomatic if he/she presents one or more symptoms listed in the questionnaire.
~For symptomatic patients, a SARS-CoV2 for multiplex PCR will be carried out. This analysis takes 75 minutes.
~For asymptomatic patients, a RT-LAMP test will be carried out. This analysis takes 5 to 15 minutes."
15762499|NCT04756609|Other|Usual emergency department practice with physician-directed diagnostic testing|The physician offers a SARS-CoV2 test according to current recommendations. The tests are prescribed as a means of diagnosis for patients presenting symptoms suggestive of Covid-19 or as a means of diagnosis for patients requiring hospitalisation for another cause, before their transfer to hospital. Patients will be cared for according to usual procedures of each hospital. Patients tested positive will be asked to fill out the DEPIST-COVID questionnaire. Patients who had not completed it will be contacted by phone to answer the questions over the phone.
15762500|NCT04756596|Diagnostic Test|DDVIT testing|One randomly selected eye will be included for each study participant. Participants respond to the DDVIT test in standard environmental lighting conditions at 4 m viewing distance. Visual acuity will be evaluated.
15762501|NCT04756596|Diagnostic Test|ETDRS testing|The same eye is included for each study participant. Participants respond to the standard ETDRS chart of our Ophthalmology Department in standard environmental lighting conditions at 4 m viewing distance. Visual acuity will be evaluated.
15762502|NCT04756583|Other|Notification system|Email and page notification sent to clinicians for patients at high-risk of mortality in 30 days and 6 months
15762503|NCT04756570|Other|Control|Individuals in this group will be randomly recruited from hospitalized stroke volunteers. Since these individuals receive routine rehabilitation 5 days a week, they will be evaluated at the beginning and end of 18 sessions over a total period of 6 weeks. Conventional physiotherapy will include normal joint movements, muscle strengthening exercises, balance and mobility exercises, and exercises to improve daily life activity.
15762504|NCT04756570|Other|Robotic Group 1|Individuals in this group will receive one session of robotic rehabilitation in addition to conventional therapy each week
15762505|NCT04756570|Other|Robotic Group 2|Individuals in this group will receive two sessions of robotic rehabilitation in addition to conventional therapy each week
15762506|NCT04756557|Other|Experimental.|Tooth Brushing HAP 2x daily repeated cleaning of all teeth 3 min. using a standardized electric tooth brush Electric (powered) toothbrushes (Oral-B; P&G, Schwalbach, Germany), brushing head: medium; will be changed every 2 months and a non-fluoridated tooth paste containing microcrystalline hydroxyapatite . HAP-toothpaste (Karex toothpaste with 10 % hydroxyapatite) If a subject shows multiple carious lesions during the course of the study, the study dentist will decide whether the subject must be excluded from the study. In this case the subject will receive additional intensive caries prophylactic measures (e.g. chlorhexi-dine gel application, dietary counselling, etc.). Caries preventive treatment (removing caries and placing a restoration) by the study centers is offered.
15762507|NCT04756557|Other|Active comparator|Tooth Brushing F 2x daily repeated cleaning of all teeth 3min.using a standardized electric tooth brush ((Oral-B; P&G, Schwalbach, Germany) and a fluoridated toothpaste (Karex Base with sodium fluoride 1450 F-), brushing head: medium; will be changed every 2 months If a subject shows multiple carious lesions during the course of the study, the study dentist will decide whether the subject must be excluded from the study. In this case the subject will receive additional intensive caries prophylactic measures (e.g. chlorhexidine gel application, dietary counselling, etc.). Caries preventive treatment (removing caries and placing a restoration) by the study centers is offered.
15762508|NCT04756544|Dietary Supplement|Lactobacillus helveticus Rosell®-52, Bifidobacterium longum Rosell®-175|probiotic
15762509|NCT04756544|Other|placebo|placebo
15762520|NCT04756466|Dietary Supplement|Placebo|Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits
15762521|NCT04756466|Dietary Supplement|Lactobacillus|Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits
15762522|NCT04756453|Device|clip-traction|A endoscopic clip with a loop of tied dental floss will be attached to the lesion. The loop will then be caught by another endoscopic clip and attached to adjacent bowel wall, thus creating tension in the tissue, making dissection easier.
15762523|NCT04756440|Behavioral|Education Program and Music Therapy|After the intervention, it is expected that their awareness of Romana cervical cancer will increase, their perception of obstacle towards screening tests will decrease and they will be tested.
15762524|NCT04756427|Drug|Sodium Citrate 4% Inj Syringe 3Ml|3 ml of sodium citrate 4% locking solution instilled into the central catheter daily during the period that parenteral nutrition is not infusing, and will be withdrawn and disposed of prior to resuming infusion of parenteral nutrition
15762525|NCT04756414|Behavioral|Exposure based face-to-face Cognitive Behavior Group Therapy|See under detailed description
15762526|NCT04756401|Drug|Carfilzomib|Given IV
15762527|NCT04756401|Biological|Daratumumab|Given IV
15762528|NCT04756401|Drug|Dexamethasone|Given PO
15762529|NCT04756401|Other|Quality-of-Life Assessment|Ancillary studies
15762530|NCT04756401|Drug|Selinexor|Given PO
15762531|NCT04756388|Other|Strategy Development|Participants engage in cognitive strategy discussions to develop new executive function strategies that can be used in daily life, and track their strategies between sessions. No computerized cognitive training.
15762532|NCT04756388|Other|Computerized Cognitive Training|Participants practice computerized training exercises targeting executive functioning skills, and complete computerized exercises between sessions.
15762535|NCT04756349|Other|composite resin restoration|All patients will receive adhesive composite resin restorations. There will be 3 groups (different adhesives): Clearfil SE, Optibond All-in-One and Prime & Bond Universal.
15762536|NCT04756336|Drug|LTX-109 gel, 3% w/w|The drug is applied to affected lesions according to treatment regimen
15762537|NCT04756323|Biological|medium dosage inactivated SARS-CoV-2 vaccine|medium dosage
15762538|NCT04756323|Biological|high dosage inactivated SARS-CoV-2 vaccine|high dosage
15762539|NCT04756323|Biological|Placebo|placebo
15762540|NCT04756310|Dietary Supplement|Retilut|antioxidants, antiangiogenic, antiinflammatory micronutrients
15762541|NCT04756310|Dietary Supplement|Theavit|antioxidants micronutrients
15762543|NCT04756245|Behavioral|Virtual Reality|Participants in this arm participate in 4 group-based behavioral counseling sessions plus 8 one-on-one coaching session within virtual reality software. Participants aim to engage in approximately 150 minutes per week of moderate-to-vigorous activity, with options including both virtual reality and real-world physical activities.
15762544|NCT04756245|Behavioral|Video Conference|Participants in this arm participate in 4 group-based behavioral counseling sessions plus 8 one-on-one coaching session within video conference software. Participants aim to engage in approximately 150 minutes per week of moderate-to-vigorous activity, with options including both streaming video and real-world physical activities.
15762545|NCT04756232|Drug|Mecamylamine Challenge|Mecamylamine 20 mg oral pill administered once
15762546|NCT04756232|Other|Placebo Comparator Challenge|Matching placebo oral pill administered once
15762547|NCT04756219|Other|Contact Video|No additional information necessary.
15762548|NCT04756219|Other|Contact Text|No additional information necessary.
15762549|NCT04756219|Other|Education Video|No additional information necessary.
15762550|NCT04756219|Other|Education Text|No additional information necessary.
15762551|NCT04756206|Drug|Dutasteride 0.5 mg|patients were randomized into 2 equal groups with 1:1 ratio using a computer-based system. Dutasteride of 0.5 mg once daily was given for 3 months compared to a placebo. Patients, data collector,s and the statistician were blinded to the type of intervention.
15762552|NCT04756206|Drug|Placebo|patients were randomized into 2 equal groups with 1:1 ratio using a computer-based system. Dutasteride of 0.5 mg once daily was given for 3 months compared to a placebo. Patients, data collector,s and the statistician were blinded to the type of intervention.
15762553|NCT04756193|Diagnostic Test|Point of care ultrasound including echocardiography, lung ultrasound, vascular ultrasound|Point of care ultrasound including echocardiography, lung ultrasound, vascular ultrasound, ECG, pulse oximetry, blood draw, spirometry
15762554|NCT04756180|Drug|Omega-3-acid ethyl ester or Placebo|Omega-3-acid ethyl ester 2 gm/day for first 4 week followed by 4gm/day for 8 week
15762555|NCT04756167|Other|Conventional Treatment|Hotpack, TENS, ultrasound and exercise
15762556|NCT04756167|Other|Myofascial Release Treatment|Hotpack, TENS, ultrasound, exercise and myofascial release therapy for subscapularis and serratus anterior muscles
15762557|NCT04756154|Drug|CHG/IPA Surgical skin preparation|Apply topically
15762558|NCT04756154|Drug|Normal saline|Apply topically
15762559|NCT04756141|Device|Continuous Glucose Monitor (CGM)|A CGM will be placed on patients with DM and COVID-19 infection and interstitial glucose will be monitored continuously while the patients are in the hospital.
15762560|NCT04756128|Drug|Colchicine 0.6 mg|"Colchicine is an oral anti-inflammatory agent that is relatively inexpensive, readily available, and has been used for generations. Approved for treatment and prophylaxis of gout flares and Mediterranean fever, it is also used in a variety of other inflammatory conditions (e.g. pericarditis and diffuse vascular inflammation such as Behcet syndrome). Colchicine binds to tubulin causing depolymerization, which interferes with neutrophil chemotaxis, adhesion, and mobilization to sites of inflammation, and contributes to reduction in superoxide production; through interference of the NLRP3 inflammasome protein complex, colchicine inhibits IL-1b, IL-6, and IL-18 production.
~For this study, patients enrolled in a colchicine containing arm will receive 0.6mg of colchicine BID (unless renal function/gastrointestinal issues require adjustments described in the protocol)"
15762561|NCT04756128|Drug|Naltrexone|"Most well known as an opioid antagonist, or a treatment for alcohol dependence, naltrexone also possesses immunomodulatory effects. Seen exclusively at low doses, this attribute is being employed in the pain community as a novel anti-inflammatory agent that has been shown to reduce symptom severity in fibromyalgia, Crohn's disease, multiple sclerosis, and complex regional pain syndrome.
~For this study, patients enrolled in a naltrexone-containing arm will take their daily dose of the medication (4.5mg) by oral suspension."
15762562|NCT04756115|Procedure|Vascular Surgery.|Open Vascular, endovascular or hybrid procedures.
15762563|NCT04756102|Other|Observation of their fetomaternal outcome|observe the fetal outcome and maternal outcome
15762564|NCT04756089|Device|Electronic breast pump|Participants randomized to the breast stimulation will use breast stimulation by hand or with an electronic breast pump (intervention) to stimulate labor.
15762565|NCT04756089|Other|Exogenous oxytocin intravenous infusion|Participants randomized to the standard care arm will use exogenous oxytocin intravenous infusion to stimulate labor.
15762566|NCT04756076|Diagnostic Test|Metal level measurements|Measure multiple metal levels
15762567|NCT04756063|Drug|Ascorbic acid|Intravenous vitamin C
15762568|NCT04756063|Other|Placebo|Normal Saline
15762569|NCT04756050|Drug|Bupivacaine HCl 0.5% Injectable Solution|20 ml of bupivacaine(Buvicaine HCl %0.5) and prilocaine(Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5mcg adrenaline per ml.(9ml bupivacaine, 9ml prilocaine and 2ml saline with 50 mcg adrenaline per ml)
15762570|NCT04756050|Drug|Prilocaine HCl % 2 injectable solution|20 ml of bupivacaine(Buvicaine HCl %0.5) and prilocaine(Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5mcg adrenaline per ml.(9ml bupivacaine, 9ml prilocaine and 2ml saline with 50 mcg adrenaline per ml)
15762571|NCT04756050|Drug|adrenaline amp 0.5mg|20 ml of bupivacaine(Buvicaine HCl %0.5) and prilocaine(Priloc HCl %2) 1:1 mixture will be prepared in a way that there will be 5mcg adrenaline per ml.(9ml bupivacaine, 9ml prilocaine and 2ml saline with 50 mcg adrenaline per ml)
15762572|NCT04756050|Procedure|Ultrasound Guided Supraclavicular Block Corner pocket approach|The blocks will be performed by an experienced anesthesiologist with a USG guidance. Local anesthetic mixture will be given to the corner pocket - where the artery and the first rib intersect in the sonoanatomical image.
15762573|NCT04756050|Procedure|Ultrasound Guided Supraclavicular Block Corner pocket + intracluster approach|The blocks will be performed by an experienced anesthesiologist with a USG guidance .10 ml of the local anesthetic mixture will be given to the described corner pack and the remaining 10 ml into the largest nerve cluster (Intracluster injection).
15762574|NCT04756050|Procedure|Ultrasound Guided Supraclavicular Block multi approach|The blocks will be performed by an experienced anesthesiologist with a USG guidance Local anesthetic mixture will be administered by multi injection method between the nerve groups seen in the sonoanatomical image.
15762575|NCT04756050|Procedure|diagraphma muscle evaluation with ultrasound|"All patients will be evaluated with USG in a head-up position facing the side to be operated before and 30 minutes after the block is performed.
~The probe will be placed perpendicular to the chest wall, in the eighth or ninth intercostal space, between the anterior axillary and midaxillary lines, 0.5 to 2 cm below the costophrenic sinus."
15762576|NCT04756037|Drug|Relugolix Combination Therapy|Participants will receive orally 1 fixed-dose combination tablet (relugolix 40 mg/E2 1 mg/NETA 0.5 mg) once daily.
15762577|NCT04756011|Other|Health related quality of life|Confidence in diabetes self care questionnaire the socioeconomic level of the family scale MINI-KID the Peds-QL
15762578|NCT04755998|Other|Use of virtual reality glasses during vaccination applications in children|"To the experimental group:
~Before the vaccine administration;
~Children's Fear Scale, and Children's Anxiety Scale-State Scale was applied to the student.
~Cartoons and virtual reality glasses that the student wanted to watch were prepared.
~While the nurse was preparing the vaccines, the student was put on virtual reality glasses and the distance settings of the lenses were adjusted and the cartoons he chose to watch during the vaccination applications started to be shown. Since virtual reality glasses can cause anxiety attacks manifested by nausea in some children, this was also tested beforehand. It took about two minutes to administer the vaccine and watch cartoons.
~Those applied after the vaccine administration;
~- Children's Fear Scale, and Children's Anxiety Scale-State Scale was applied to the student."
15762579|NCT04755985|Drug|AD-213-B|1 tablet administered before the breakfast during 5 days
15762580|NCT04755985|Drug|AD-2132|1 tablet administered before the breakfast during 5 days
15762581|NCT04755972|Other|Inhalation of N-acetylcysteine|Group 1 will receive N-acetylcysteine inhalation every 12 hours from the beginning of invasive mechanical ventilation.
15762582|NCT04755972|Other|Inhalation of 5% sodium chloride|Group 2 will receive inhalation with a 5% sodium chloride solution every 12 hours from the beginning of invasive mechanical ventilation.
15762583|NCT04755972|Other|Inhalation of 8,4% sodium bicarbonate|Group 3 will receive inhalation of 8.4% sodium bicarbonate every 12 hours from the beginning of invasive mechanical ventilation.
15762584|NCT04755946|Drug|Roflumilast|adding one tablet of roflumilast 500 mcg to the standard ACEI (captopril) for diabetic nephropathy management
15762585|NCT04755946|Drug|Placebo|Placebo
15762586|NCT04755933|Behavioral|Raising Confident Children Course|An online learning tool consisting of 8 different modular components, designed to reduce the transmission of anxiety from parents to children. The modular components include: a core starter about anxiety, the role of avoidance, using play to develop childrens confidence, using Emotion Coaching with children, managing difficult behaviour, the role of sleep, exercise and diet, reducing overprotection, modelling confident behaviour and managing difficult behaviour.
15762587|NCT04755920|Drug|SGM-101|Fluorescence-guided surgery
15762588|NCT04755907|Procedure|surgical resection|Surgical resection will be performed for locoregional lesions or liver metastases.
15762589|NCT04755907|Other|adjuvant chemotherapy|Regimens of adjuvant chemotherapy are directed by clinical guidance and experience.
15762590|NCT04755907|Other|neoadjuvant therapy|Regimens of neoadjuvant chemotherapy are directed by clinical guidance and experience.
15762591|NCT04755894|Drug|HDDO-1756|single dose
15762592|NCT04755894|Drug|HDDO-17561/HDDO-17562|single dose
15762593|NCT04755881|Other|Occurence of biphasic reaction following anaphylaxis|Prospective observation for biphasic reaction following anaphylaxis and subsequent analysis (comparison between usual care and the care that would have been suggested by the three proposed clinical decision rules).
15762594|NCT04755868|Drug|Talazoparib|The Arm A (Experimental arm) Maintenance therapy with talazoparib (1mg once daily) (once daily 1.0 mg oral administration), 103patients
15762595|NCT04755868|Drug|Placebo|The Arm B (Control arm) Maintenance therapy with placebo (once daily 1.0 mg oral administration), 103patients
15762596|NCT04755829|Device|BreathX test for breath VOCs|Breath samples are collected into an ultra-clean bag and breath VOCs are analyzed with GC-SAW.
15762597|NCT04755816|Behavioral|Sodium intervention|The sodium dietary intervention provides uses location services to determine when a participant is at home, arrives at a grocery store or arrives at a restaurant. The user receives a tailored message to assist with making dietary choices based on sodium content.
15762598|NCT04755816|Behavioral|Clinical worsening intervention|The intervention adapts to the participant's reported symptoms and provides feedback with a global health status indicator (HSI). Users will receive tailored push notification based on their HSI status.
15762599|NCT04755816|Behavioral|Educational content|Standard heart failure educational information and a daily symptom survey.
15762600|NCT04755803|Procedure|Penoplasty|"Modified penoplasty technique:
~Degloved the penile skin and excise the inner prepuce.
~Advanced penoscrotal skin to cover penile shaft
~Fixed the penis base and reconstructed the penoscrotal angle"
15762601|NCT04755790|Device|Point Digit|Patient is fit with Point Digit partial hand prosthetic system
15762602|NCT04755764|Drug|Labetalol|Beta blocker
15762603|NCT04755764|Drug|Atenolol|Beta blocker
15762604|NCT04755764|Drug|Nifedipine|Calcium channel blocker
15762605|NCT04755751|Diagnostic Test|Cardiopulmonary exercise testing (CPET)|CPET using a cycle ergometer (COSMED, Rome, Italy) beginning with a no resistance warm up lasting 1 to 3 minutes and followed with an incrementing resistance adapted to the patient's functional capacities according to the examiner's free judgment and ranging from no resistance (20 Rounds Per Minute (RPM)/minute) 5 to 20 Watts/minute on ramps or by successive stages
15762606|NCT04755738|Combination Product|Almonertinib plus microwave ablation|Patients were treated with almonertinib firstly.When almonertinib achieved the maximal response, microwave ablation was conducted on the primary lung tumors.
15762607|NCT04755725|Device|Epidural catheter|epidural catheter inserted pre induction
15762608|NCT04755725|Device|rectus sheath catheter|The surgeon will place one hand inside the abdomen and with the other hand inserted the Tuohy needle through the skin and fascia. The surgeon will feel when the needle tip is just superfacial to interface between the peritoneum and muscle layer and avoid penetration of inferior epigastric artery. The procedure will be repeated on the contralateral
15762609|NCT04755712|Drug|Rachianesthesia|Administration of different anesthesia drugs in accordance with the courant practice (mixture of bupivacaine and sufentanil)
15762610|NCT04755712|Drug|Sodium Chloride Injection|"Subcutaneous injection of Sodium chloride at the usual quadratum lumburum block 2 (QLB2) injection site under ultrasound (sham-QLB2)."
15762611|NCT04755712|Drug|Morphine|Morphine via pump (patient controlled analgesia)
15762612|NCT04755699|Device|Transcutaneous Electrical Stimulation|The study involves the administration of various electrical pulses being delivered to muscles and/or the spinal column with an investigational neurostimulator to evoke various limb movements in order to improve functional movement.
15762613|NCT04755686|Procedure|Fast-tracking|
15762614|NCT04755673|Other|Atrantil (Medical Food)|All participants will be given 28 days supply of Atrantil. The impact of the intervention will be measured by daily symptom surveys as well as a hydrogen methane breath test administered at the end of the 28 days of treatment to identify if methane levels have changed.
15762615|NCT04755660|Behavioral|Exercise behavior change for resistance exercise|The intervention includes motivational interviews and self-efficacy theory-based exercise behavior and home-based resistance exercise intervention (by Elastic Band or non- Elastic Band ), and 3 follow-up telephone calls. The usual care group will receive exercise counseling.
15762616|NCT04755647|Drug|Nitric Oxide-Releasing Solution|Active antimicrobial
15762617|NCT04755647|Drug|Saline solution, hypotonic|Placebo
15762618|NCT04755634|Device|Hyaluronic Acid|Injectable
15762619|NCT04755621|Other|Core stability training|Core stability exercises
15762620|NCT04755621|Other|Rocabado Exercises|Exercises for Temporomandibular Disorders
15762621|NCT04755608|Other|Low Intensity Exercises with Blood Flow Restriction|In the exercise protocol, people exercised resistance between 20% and 30% of 1 MaxRepetition with free weight. In addition, blood flow was restricted in 70% of the arterial occlusion pressure of the individual with the help of a cuff during exercise.
15762622|NCT04755608|Other|High Intensity Resistant Exercise|People included in the study did resistance exercise with free weight at 70-80% of 1 MT.
15762623|NCT04755595|Drug|Botox Cosmetic Injectable Product|Acetylcholine release inhibitor and a neuromuscular blocking agent
15762624|NCT04755595|Device|Juvéderm Voluma XC|Gel implants consisting of cross-linked hyaluronic acid
15762625|NCT04755595|Device|Juvéderm Volbella XC|Gel implants consisting of cross-linked hyaluronic acid
15762626|NCT04755569|Device|ODOCOR II CCM LEADS|ODOCOR II CCM LEADS Implantation
15762627|NCT04755556|Other|home based intensive bimanual training|Home Based Intensive Bimanual Training with Routine Physical Therapy bimanual training includes. functional activities play with ball, make a dough, make beads, make blocks .Routine Physical Therapy includes stretching spastic muscles, EMS, normalizing muscle tone.
15762628|NCT04755556|Other|Routine Physical Therapy|Routine physical Therapy includes stretching spastic muscles, EMS, normalizing muscle tone.
15762629|NCT04755543|Drug|LP002|600mg or 900 mg by intravenous (IV) infusion on Day 1, every 2 weeks (Q2W).
15762630|NCT04755543|Drug|Cisplatin|50mg/m2 IV on Day 1, Q2W
15762631|NCT04755543|Drug|Fluorouracil|2000 mg/m2 IV continuous infusion over 48 hours from Day 1, Q2W
15762632|NCT04755543|Biological|OH2 oncolytic virus|106 or 107 or 108 CCID50/mL by intra-tumoral injection, Q2W
15762633|NCT04755530|Dietary Supplement|Regular whole milk|400 g/day of regular whole milk
15762634|NCT04755530|Dietary Supplement|Yogurt with live bacteria|400 g/day of yogurt with live bacteria
15762635|NCT04755530|Dietary Supplement|Yogurt with inactivated bacteria|400 g/day of yogurt with inactivated bacteria
15762636|NCT04755530|Dietary Supplement|Acidified whole milk|400 g/day of yogurt with acidified whole milk
15762637|NCT04755517|Other|Frequent information of cytological/ HPV DNA screening results|"All participants will be referred to pertinent diagnosis and treatment according to local standard of care (Käypä hoito 2010) should the cytological screening results (HSIL, ASC-H, AGC-FN) or three consecutive LSIL findings at repeated control visits within 3 years indicate it. The most common screening results (ASCUS, LSIL) are, however, not convened to arm A2 participants before age 28.
~All cytology and HPV DNA results results are being revealed to all trial participants at age 28 at the study end."
15762638|NCT04755504|Diagnostic Test|EEG behind the ear|2 additional electrodes behind each ear will record EEG
15762639|NCT04755491|Device|Continuous veno-venous hemofiltration|Treatment of KDIGO stage 3 AKI by CVVH, in which renal replacement therapy is applied using a convection technique (ultrafiltration). Indication, choice of CRRT modality, and CRRT settings are made by the clinician in charge, following international recommendations. The measurement of chloride transfer over 24h is performed during CVVH treatment.
15762640|NCT04755491|Device|Continuous veno-venous hemodialysis|Treatment of KDIGO stage 3 AKI by CVVD, in which renal replacement therapy is applied using a diffusion technique (dialysis). Indication, choice of CRRT modality, and CRRT settings are made by the clinician in charge, following international recommendations. The measurement of chloride transfer over 24h is performed during CVVD treatment.
15762641|NCT04755491|Device|Continuous veno-venous hemodiafiltration|Treatment of KDIGO stage 3 AKI by CVVHDF, in which renal replacement therapy is applied using a combination of diffusion technique (dialysis) and convection technique (ultrafiltration). Indication, choice of CRRT modality, and CRRT settings are made by the clinician in charge, following international recommendations. The measurement of chloride transfer over 24h is performed during CVVHDF treatment.
15762642|NCT04755478|Procedure|Thoracotomy|Participants will undergo lobectomy via open thoracotomy at the discretion of the surgical team.
15762643|NCT04755478|Procedure|VATS|Participants will undergo lobectomy via VATS at the discretion of the surgical team.
15762644|NCT04755465|Device|Neuromuscular Electrical Stimulation|"Neuromuscular Electrical Stimulation (NMES) is based on the principle of creating a contraction by stimulating the nerve fibers innervating the related muscle in the healthy muscle and the muscle fibers in the denervated muscle with electrical current. The electric currents used in stimulation of muscles and nerves perform this function by changing the electrical potential of cell membranes.
~It is contraindicated in pregnancy, presence of pacemaker, severe heart disease, epilepsy, fracture, dementia and impaired consciousness. We prevent contraindicated situations by excluding volunteer participants with these characteristics."
15762645|NCT04755465|Other|Structured Exercise|Warm-up exercise, main training program and cool down exercise. Main training consists of resistance exercises to be applied with resistance bands of different resistance or with the patient's own body weight. Our prescribed training protocol includes 4-6 different exercises for each limb (bench press with resistance band, upper extremity proprioceptive neuromuscular facilitation exercises, biceps/triceps curl, leg press, knee extension, 4-way hip motion, mini squat). Intensity, sets and number of repetitions will be adapted to a target score between 12 and 14 using the Borg scale. It will be applied as low intensity, long-term passive stretching exercises to the pectoral, hamstring and gastrocsoleus muscle groups. Patients will perform 1-2 sets of 8-10 repetitions of each resistance exercise determined by their level of fatigue. Resistance will be increased every three visits. If the patient complains of excessive fatigue, the resistance will be reduced to the previous level.
15762646|NCT04755452|Procedure|Low intra-abdominal pressure|7 mm Hg pneumoperitoneum during robot-assisted laparoscopic surgery
15762647|NCT04755452|Procedure|High (standard) intra-abdominal pressure|12 mm Hg pneumoperitoneum during robot-assisted laparoscopic surgery
15762648|NCT04755439|Procedure|DHCA|DHCA THE USE OF SEREBRAL PROTECTİON TECHNİQUE
15762649|NCT04755426|Behavioral|Preference assessment tool|A brief shared decision making tool that helps patients clarify their treatment goals and preferences and communicate those preferences to their HCP.
15762650|NCT04755413|Other|Medical/Behavioral therapy|"Sedentary lifestyle: Advise increasing exercise to at least 30 minutes of moderate-intensity aerobic activity 5 days a week.
~Overweight/Obese: Advise calorie reduction, dietician consultation.
~Smoking: standard smoking cessation advice and literature and medical therapy as indicated to include Wellbutrin, nicotine patch etc.
~High LDL cholesterol: a) Start high dose statin if patient not on high dose statin.
~b) If on high dose statin, add ezetimibe 10mg daily c) If statin intolerant, start ezetimibe 10mg, colestid or other bile sequestrant combination.
~d) If still not at goal, start PCSK-9 inhibitor e) LDL cut off of <55mg/dl in diabetes
~Blood Pressure optimization treatment following 2020 International Society of Hypertension Global Hypertension Practice Guidelines.
~Diabetes management: HbA1c goal 6.5%"
15762651|NCT04755413|Other|Standard of Care|Participants will receive standard of care therapy prescribed by their primary care physician and/or cardiologist.
15762652|NCT04755413|Other|Registry|Participants with BRS of 0 will get measurements of BRS at the time-points specified for the randomized subjects and also for adverse events.
15762653|NCT04755400|Other|isotonic saline 9%|1 Liter of Isotonic saline administered I.V.
15762654|NCT04755400|Dietary Supplement|Potassium nitrate|24 mmol of Potassium nitrate is the active comparator substance, that is ingested every morning for 4 days before and on the examination day.
15762655|NCT04755400|Dietary Supplement|Potassium chloride|24 mmol of Potassium nitrate is the placebo substance, that is ingested every morning for 4 days before and on the examination day.
15762656|NCT04755387|Drug|Ticagrelor 90mg|Standard strategy initially receive ticagrelor 90mg twice daily for 12 months.
15762657|NCT04755387|Drug|Ticagrelor 60/45mg|In-hospital treatment with standard strategy ticagrelor 90mg twice daily, following de-escalation strategy ticagrelor 60/45mg twice daily after discharge for 12 months.
15762658|NCT04755374|Other|Discharged ≤ 21 days|Discharged from palliative care unit in equal less than 21 days
15762659|NCT04755374|Other|Prolonged discharge|Discharged from palliative care unit in longer than 21 days
15762710|NCT04755036|Other|Survey and case vignette|We sent a survey and case vignette cases to every responsible in each center
15762711|NCT04755023|Drug|Bis-Chloroethyl-Nitroso-Urea (BCNU) withTemozolomide|Chemotherapy (BCNU) will be delivered at Day 1. between day 1 and day 5, temolozomide will be administered . One cycle is planned every 6 weeks until 6 cycles.
15762712|NCT04755010|Device|Linq II implantable cardiac monitor|Implantation of Linq II implantable cardiac monitor
15826143|NCT04234867|Drug|Placebo oral tablet|once daily for 5 days
15762660|NCT04755361|Behavioral|Housing Outreach Project Collaboration (HOP-C)|HOP-C has several components: HOP-C Case management is outreach-based (emphasizing community and home contacts) and participant goal-driven, providing coaching and skill building in key functional domains and assistance with navigating various systems (justice, housing, employment, health, education). The mental health component has two parts. One is a weekly, 90-minute, mental health and wellness-oriented group. The group acts, for most, as a stepped care approach, with members moving on to access individual psychotherapy as needed. Peer support is provided by youth with a history of lived experience of homelessness who have successfully achieved housing stability and progress in major life domains. Peers receive extensive training and are formally hired into these roles with their being 2-3 peers on the team.
15762661|NCT04755348|Other|Product A|A 4mg nicotine pouch product
15762662|NCT04755348|Other|Product B|A 4mg nicotine pouch product
15762663|NCT04755348|Other|Product C|A 2mg nicotine lozenge product
15762664|NCT04755348|Other|Product D|A 2mg nicotine lozenge product
15762665|NCT04755348|Other|Product E|A 2mg nicotine lozenge product
15762666|NCT04755348|Other|Product F|A 2mg nicotine lozenge product
15762667|NCT04755335|Diagnostic Test|Ultrasound|In this project, The investigators will use Alpinion ECUBE-12R (Alpinion, Bothell, WA) US platform. This state-of-the-art research US machine provides beam formed as well as Plane-Wave imaging options that allow high frame rate imaging. The investigators have characterized the acoustic output of this system for safe human studies and obtained the IRB approval for human studies. It should be noted that our technique is not limited to the Alpinion system; the investigators can also use other US systems, such as Verasonics, Vantage, (Redmond, WA). This technique can be adapted to other modern US machines in the future.
15762668|NCT04755322|Drug|Hydroxychloroquine|Hydroxychloroquine 400 mg at start of pregnancy
15762669|NCT04755322|Drug|Folic acid|5 mg
15762670|NCT04755322|Drug|Low-dose aspirin|75 mg
15762671|NCT04755322|Drug|Placebo|oral tablets
15762672|NCT04755309|Behavioral|Rhythmic intervention|"The rhythmic intervention consists in an ecological and non-invasive intervention based on enriched auditory and musical active experience. It is based on the most recent scientific evidence in the field and provides exposure to and active synchronization with complex musical rhythms. It is thought to promote the infant's ability to recognize and process the complex rhythms of spoken language. Importantly, it taps into and empowers early auditory processing skills. The intervention includes several tasks described in the literature, for example tapping and bouncing at the beat of complex musical rhythms.
~The intervention takes place in small groups of infant-caregiver pairs (N=4/5) for 1 hour/week for 6 weeks."
15762673|NCT04755309|Behavioral|Passive auditory stimulation|The same auditory stimulation is provided to infants, but no active tasks are proposed. Children and caregiver are entertained with motor and cognitive tasks not related to the auditory stimuli presented. The intervention takes place in small groups of infant-caregiver pairs (N=4/5) for 1 hour/week for 6 weeks.
15762674|NCT04755296|Device|Low level laser therapy|Low level laser therapy was applied immediately before each aerobic exercise training session by using a multidiode cluster (with four diode spots; Polaris2, manufactured by Astar ABR, Poland) )on 12 sites on the lower limb (6 on quadriceps ( 2 centrally on rectus femoris and vastus intermedius,2 laterally on vastus lateralis, and two medially on vastus medialis), 4 on hamstrings and 2 on gastrocnemius) with the following parameters: 808 nm, continous output, 200 mW each diode (total of 800 mW) power output, 24 J energy on each site (6 J for each spot) , 40 seconds at each site (8 minutes of total treatment time in lower limb) and 288 J total energy delivered per lower limb, 48 irradiation points per lower limb ,3 sessions weekly for 12 weeks.
15762675|NCT04755296|Other|Aerobic exercises|Aerobic exercise program consisted of walking on the treadmill at a rate of 3 sessions/week for 12 weeks, with each session lasting for 40 minutes in the form of warming up for 5 minutes at intensity of <50% of the previously determined VO2max of each participant, 30 minutes of treadmill exercises at intensity of (70-85%) of the previously determined VO2max of each participant then 5 minutes cooling down at intensity of<50% of the previously determined VO2max of each participant.
15762676|NCT04755296|Other|Traditional physical therapy program|Patients were received traditional physical therapy program in the form of (stretching and strengthening exercises for all affected areas, diaphragmatic breathing exercises and activities of daily living).
15762677|NCT04755283|Biological|Abelacimab|Abelacimab provided as liquid in vial (150 mg/mL)
15762678|NCT04755283|Drug|Rivaroxaban|Rivaroxaban 15 mg and 20 mg provided as commercially available film-coated tablets
15762679|NCT04755270|Device|VR Glasses|techniques of hypnofertility and VR glasses
15762680|NCT04755257|Device|Isokinetic test|Using IsoMed 2000 device (D. & R. Ferstl GmbH, Hemau, Germany) we conducted the isokinetic test of concentric (CON) and eccentric (ECC) shoulder internal (IR) and external (ER) strength at the angular velocity of 60˚/s in both Method I (scapular position) and Method II (25⁰ Abd and 20⁰ ER). There were seven days between the testing sessions, and both tests were conducted at the same time of day. The same examiner with experience in performing isokinetic testing with IsoMed 2000 tested all subjects in both testing sessions.
15762681|NCT04755244|Drug|evorpacept|Fusion protein that blocks CD47-SIRPalpha pathway
15762682|NCT04755244|Drug|venetoclax|BCL-2 inhibitor
15762683|NCT04755244|Drug|azacitidine|Hypomethylating agent (HMA)
15762684|NCT04755231|Device|AcrySof IQ PanOptix Presbyopia Correcting IOL|UV and blue-light filtering foldable multifocal IOL with a +2.17 diopter (D) addition power of intermediate visual acuity and a +3.25 D addition power of near visual acuity. This device is approved in China.
15762685|NCT04755231|Procedure|Cataract surgery|Cataract extraction by phacoemulsification, followed by implantation of the AcrySof IQ PanOptix Presbyopia Correcting IOL
15762686|NCT04755218|Other|Vaginal Misoprostol|"Although labeled experimental for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States"
15762687|NCT04755218|Other|Oral Misoprostol|Patients will receive standard oral misoprostol 100mcg according to current labor induction protocol
15762713|NCT04754997|Other|Traditional exercise training|The therapy program will planned for 12 weeks and the sessions will be performed in 45 minutes (min) for 2 days a week. The lower extremity range of motion exercise and strengthening exercises will be applied on the mat 10 repetition. The number of repetitions and type of exercises will be changed every 3 weeks.
15827064|NCT04227782|Other|Stable Isotope Study|Stable Isotope study
15762688|NCT04755179|Procedure|Laparoscopic appendectomy|"Laparoscopic appendectomy is performed according to daily practice but with the following standardized key points:
~Conventional laparoscopy (three-trocar technique)
~In case of purulent fluid: Suction and no peritoneal lavage procedure
~Skelletizing of the mesoappendix (coagulation/clips according to routine practice locally)
~Appendiceal stump closure: with two endoloops and dissected between the endoloops. In case of involvement of the appendiceal base, the use of endostapler is recommended.
~Withdrawal of appendix: principle of abdominal wall protection is followed (trocar technique / endobag)
~No drain placement, no nasogastric tube, and no urinary catheter routinely, only on indication.
~Closure of wounds as appropriate"
15762689|NCT04755179|Procedure|Open appendectomy|"Open appendectomy will be performed according to the following standardized key points:
~Gridiron incision at the right lower quadrant. (McBurney's point)
~After obtaining access to the abdominal cavity the principle of abdominal wall protection will be followed.
~The appendiceal stump will be closed by ligation, not a purse string suture.
~Closure of wounds as appropriate"
15762690|NCT04755179|Procedure|Non-operative treatment|"Non-operative treatment consisting of administration of intravenous antibiotics with or without drainage procedures (in case of an abscess), reserving an appendectomy for those not responding or with recurrent disease.
~One of the two antibiotic regiments:
~Combination A:
~Amoxicillin/clavulanic acid 25/2.5mg/kg 6 hourly (total 100/10 mg/kg daily. Maximum 6000/600mg a day) for children <40 kg OR Amoxicillin/clavulanic acid 1000/200mg/kg 8 hourly (total 3000/6000 mg/kg daily) for children > 40 kg
~Gentamicin 7mg/kg once daily
~Combination B:
~Cefuroxim 25 mg/kg 6 hourly (total 100 mg/kg/day. Maximum 6gram/day)
~Metronidazole 10mg/kg 8hourly (total 30 mg/kg/day. Maximum 4000 mg/day) In case of peri-appendicular abscess the decision can be made to perform a drainage procedure either percutaneously or surgical."
15762691|NCT04755179|Procedure|Direct appendectomy|laparoscopic or open appendectomy as described
15762692|NCT04755166|Procedure|Lateral ridge augmentation|
15762693|NCT04755153|Behavioral|Kaiser Bundle|Kaiser Permanente demonstrated that a bundle of evidence-based interventions implemented within a large, integrated health system in Northern California significantly increased blood pressure control rates.
15762694|NCT04755140|Behavioral|Questionnaires|The patient and an informant will be asked to complete a questionnaire about his or hers current and past physical thinking abilities.
15762695|NCT04755140|Behavioral|Interviews|Cognition and memory interviews will take place with the patient.
15762696|NCT04755140|Diagnostic Test|Blood Test|Three blood draws will occur to assess patients immune response, metal levels, and cardiac health.
15762697|NCT04755140|Diagnostic Test|Echocardiogram|Each echocardiogram takes about 3 hours and 30 minutes. This test uses sound waves to look at your heart. The person doing the test will press on your chest with a machine to obtain the pictures. The pressure may be uncomfortable. The echocardiogram will involve an image enhancement agent infusion to obtain better images.
15762698|NCT04755127|Procedure|Arthroscopic synovectomy of the wrist|Wrist arthroscopy in day surgery setting with debulking of synovitis, inspection of cartilage, ligament, tendon and bone damage, collection of synovial biopsies and deposition of intra-articular corticosteroids (40mg triamcinolone acetonide)
15762699|NCT04755127|Drug|Intra-articular corticosteroid injection|Injection with 40mg triamcinolone acetonide (kenacort) in the wrist
15762700|NCT04755114|Other|Turkish Music|Turkish Music;In choosing the music, patients will be asked about their favorite vocalist and music pieces before the procedure. The researcher will then download these music pieces from YouTube and create a 30-minute list and listen to patients.
15762701|NCT04755114|Other|comedy movie|Prior to the research, attention will be paid to the selection of comedy films that do not contain violence, swearing and obscene scenes that may adversely affect patients. Prior to the research, attention will be paid to the selection of comedy films that do not contain violence, swearing and obscene scenes that may adversely affect patients. In the selection of comedy films, the opinions of two experts from Mimar Sinan University, Faculty of Fine Arts, Department of Cinema and Television and İnönü University will be preferred, and the films Kemal Sunal and Şener Şen, one of the actors that Turkish people know closely, laugh most and have settled into their culture, will be preferred.
15762708|NCT04755062|Behavioral|Micronutrient-dense plant-rich Intervention|"The mNDPR dietary protocol is designed to be (1) micronutrient rich (i.e., high in plant-derived phytochemicals, antioxidants, vitamins, and minerals); (2) nutritionally adequate and diverse; (3) hormonally favorable, avoiding carbohydrates with a high glycemic index that could elevate levels of serum insulin and minimizing animal protein that may invoke an inflammatory response; and (4) encourage intake of regular meals, limited consumption of snacks, and an overnight fast of at least 12 hours. The calorie breakdown of the diet is derived from approximately: 30-60% vegetables, 10-40% beans/legumes, 10-40% fruit, 10-40% seeds/nuts, 20% whole grains, no more than 10% naturally raised and wild animal products, poultry, eggs, fish, dairy, oil and white potatoes."
15762709|NCT04755049|Diagnostic Test|The Chinese version of the American Shoulder and Elbow Surgeons standardized shoulder assessment form questionnaire|The Chinese version of the American Shoulder and Elbow Surgeons standardized shoulder assessment form questionnaire
15762714|NCT04754997|Other|Specific exercise training|The therapy program will planned for 12 weeks and the sessions will be performed in 45 minutes (min) for 2 days a week. Exercise training consists of lower extremity closed kinetic chain exercises and core exercises. The type of exercise changes every 3 weeks.
15762716|NCT04754971|Other|psycho-education program|Psychoeducation Practice 1 day per week, 60-90 min. sessions will take 8 weeks. At the end of the training, the final test will be applied to the experimental and control group. 3rd and 6th month follow-up measurements are planned to be carried out intermittently at the end of the month.
15762717|NCT04754958|Device|Immersion in virtual reality using Nordic Neurolab(™) Visual System|In addition to the standard MRI procedure, the VR intervention group will be looking at stereoscopic computer generated images through a pair of head-coil-mounted googles (Nordic Neurolab ™ Visual System). Two markers (color balls) will be fixed on their knees to capture their movement (camera tracking from the outside of the MRI room). The VR scenario will consist in showing a replication of the actual MRI examination room, as seen from the point of view of the participant lying on the MRI bed, but without the MRI tunnel. Participant can see themselves in the large room (a simplified gender-matched avatar), and an entertaining video can be displayed.
15762718|NCT04754945|Drug|Bortezomib|Given SC
15762719|NCT04754945|Drug|Cyclophosphamide|Given IV or PO
15762720|NCT04754945|Drug|Dexamethasone|Given IV or PO
15762721|NCT04754945|Biological|Isatuximab|Given IV
15762722|NCT04754932|Other|Cognitive Stimulation Therapy|Group-based therapy for people living with mild to moderate stage dementia, delivered by two trained facilitators.
15762723|NCT04754919|Other|Transition intervention group|Support and on-going treatment intervention; monitoring the uptake of routine annual diabetes tests and encouraging to access where default observed General specialist diabetes support and provision of education and referral to other specialist healthcare agencies as individual requires
15762724|NCT04754919|Other|Post transition group|The previous fifty eligible young people who have transitioned to adult service, will be compared with the active comparator group.
15762725|NCT04754906|Other|Sequence 1|perform arm movements towards a target
15762726|NCT04754906|Other|Sequence 2|judge the verticality of an object
15762727|NCT04754906|Other|Sequence 3|In standing position, point as quickly as possible with the right arm at the diode that will light up in front of the participant.
15762728|NCT04754906|Other|Sequence 4|Composed of 5 sessions of about 15 minutes each (5 consecutive days), it will be required to perform a walking test (10 meters) in 3 different conditions and a manual dexterity test. Participants will be asked to imagine carrying out these tests during the training sessions.
15762729|NCT04754906|Other|Sequence 5|Composed of 5 sessions of about 20 minutes each (5 consecutive days), it will be asked to perform pointing movements of the arm. It will be asked to imagine these movements during training sessions.
15762730|NCT04754893|Device|Healthdot application|Healthdot device is applied on subject's chest after surgery
15762731|NCT04754880|Diagnostic Test|Comparison of oxidative and antioxidative markers between groups|Oxidant and anti-oxidant markers
15762732|NCT04754867|Behavioral|Future Self Virtual Reality Image - Normal Aging|Using software developed for this purpose, a current photograph of the subject will be aged and presented through a visual medium. The image (face) will be rendered as a 3D virtual reality avatar.
15762733|NCT04754867|Behavioral|Future Self Virtual Reality Image - Smoking Consequences Aging|Using software developed for this purpose, a current photograph of the participant will be aged showing the results of continued smoking and presented through a visual medium. The image (face) will be rendered as a 3D virtual reality avatar.
15762734|NCT04754867|Behavioral|Current Self Virtual Reality Image|Using software developed for this purpose, a current photograph of the participant will be rendered as a 3D virtual reality avatar.
15762735|NCT04754867|Behavioral|Letter - 20 years|"Participants will write a 200-300 word letter to the self they see in that image in 20 years' time. The instructions will read: Think about who you will be in 20 years from now, and write about the person you are now. What things are important and dear to you, and how do you see your life?"
15762736|NCT04754867|Behavioral|Letter - 3 months|"Participants will write a 200-300 word letter to the self they see in that image. The instructions will read: Think about who you will be in 3 months from now, and write about the person you are now. What things are important and dear to you, and how do you see your life?"
15762737|NCT04754841|Other|platelet cryopreservation|The cryopreservation of platelets will be carried out using as alternatives of cryopreservative solution: 5% dimethylsulfoxide alone (solution 1) or combined with 5% dextrose 160 mg (solution 2) or with 2% albumin (solution 3) and then be frozen at -80 ° C
15762738|NCT04754828|Other|Assigned to a rounding style|Team rounded on new admissions either in hallway or at the bedside
15762739|NCT04754815|Drug|Pembrolizumab|PD-L1 inhibitor administered as an intravenous (IV) infusion.
15762740|NCT04754815|Drug|Pemetrexed|Folate analog metabolic inhibitor administered as an intravenous (IV) infusion single agent chemotherapy for advanced NSCLC
15762741|NCT04754815|Drug|Paclitaxel|A novel antimicrotubular agent administered as an intravenous (IV) infusion single agent chemotherapy for advanced NSCLC
15762742|NCT04754815|Drug|Nab-paclitaxel|Microtubule inhibitor administered as an intravenous (IV) infusion indicated for the treatment of locally advanced or metastatic NSCLC
15762743|NCT04754815|Other|Laboratory Biomarker Analysis|Correlative studies
15762744|NCT04754802|Drug|PH94B Nasal Spray|Nasal spray delivered 20 minutes before the public speaking stressor
15762745|NCT04754802|Drug|Placebo Nasal Spray|Nasal spray delivered 20 minutes before the public speaking stressor
15762746|NCT04754789|Drug|Atorvastatin|preloading with high dose statins (atorvastatin 80mg) with loading dose of dual antiplatelet( asprine 300 mg and ticagrelor 180 mg) pre-primary PCI
15762747|NCT04754789|Drug|Aspirin|Loading dose of dual antiplatelet (asprine 300 mg and ticagrelor 180 mg)
15762748|NCT04754776|Biological|ChAdOx1 RVF|Single dose of ChAdOx1 RVF
15762749|NCT04754763|Drug|Dentin-Bonding Agents|3M ESPE Scotchbond™ Universal Adhesive systems is a seventh generation single-bottled one-step self-etch adhesive system.
15762789|NCT04754425|Drug|Erdafitinib|Given PO
15763171|NCT04751396|Other|Educational Intervention|Navigate educational tool
15762750|NCT04754763|Drug|Propolis|Propolis was obtained from Margalla hills, Islamabad by NARC (National Agriculture Research Council, Islamabad). Plant source origin is Acacia modesta and Apis mellifera bees collect it. The 30% ethanolic extract of propolis from raw propolis was obtained in Pakistan Council of Scientific & Industrial Research (PCSIR) by dissolving the propolis in 95% ethanol and straining out the precipitate
15762751|NCT04754750|Drug|Paliperidone Palmitate 156 MG/ML Prefilled Syringe [Invega]|
15762752|NCT04754750|Drug|Paliperidone Palmitate 546 MG Intramuscular Suspension, Extended Release [INVEGA TRINZA]|
15762753|NCT04754737|Other|No antibiotic|No antibiotics will be given prior to intravesical injection of onabotulinumtoxinA
15762754|NCT04754737|Other|Prophylactic antibiotic|This is the current standard of care, this group of patients will be given a single dose of prophylactic antibiotic prior to the injection of onabotulinumtoxinA via cystoscopy
15762755|NCT04754737|Procedure|cystoscopic injection of onabotulinumtoxinA|cystoscopic injection of onabotulinumtoxinA
15762756|NCT04754724|Diagnostic Test|GIMate|Use of GIMate to detect lactose malabsorption
15762757|NCT04754724|Diagnostic Test|H2 Check|Use of H2 Check to detect lactose malabsorption
15762759|NCT04754698|Biological|CoronaVac|CoronaVac (Sinovac Biotech Ltd., Beijing, China)
15762760|NCT04754685|Drug|Intra-articular injection of platelet-rich plasma|The patient was put in 20 degree flexion in supine position with the knee. Under aseptic conditions, a 21-gage needle was used to inject 5 mL of PRP into the suprapatellar knee joint pouch, using a superolateral method. Local anesthetics were not used. Patients were instructed after the injection to refrain from physical exercise for at least 24 hours but no restriction was specified regarding activities of daily living. Three IA-PRP injections were administered at 2-week intervals. The same physician who was engaged in selecting and testing participants did the injections
15762761|NCT04754672|Behavioral|Continuous aerobic and resistance exercise intervention|Continuous aerobic and resistance exercises intervention
15762762|NCT04754672|Behavioral|Continuous aerobic and aerobic interval exercise intervention|Continuous aerobic and aerobic interval exercise intervention
15762763|NCT04754659|Device|Stentgraft|Stentgraft treatment for AAA. Comparison between supra vs infrarenal fixation.
15762764|NCT04754620|Other|real time online video visit|Participants have received an online visit by a smartphone application
15762765|NCT04754607|Other|Low-Level Laser Therapy|Eight target points (superior, mediolateral, inferior border of the right and left thyroid lobes, right and left sides of the isthmus) will be marked with a surgical pen by determining the thyroid borders on the skin by thyroid ultrasonography by the specialist physician. Low-level laser (28.57 J / cm2) fixed applications will be made on the thyroid gland, approximately 1 cm from each other. In practice, the patient's neck will be maintained in the extension position. Each application will last 20 seconds and the radiant energy will be 2 J, the tip of the laser will be kept in contact with the skin and upright. Duration of treatment is 6 sessions 2 days a week. The cumulative dose will be 96 J.
15762768|NCT04754581|Other|Maximal ATP Production (ATPmax)|ATPmax will be measured in order to determine in vivo mitochondrial capacity. The magnetic resonance scans to measure mitochondrial energetics will also be performed.
15762769|NCT04754581|Other|Exercise Testing (VO2max)|Aerobic fitness level will be assessed while participant pedals on a stationary bicycle/walk on a treadmill. The volume of oxygen intake and carbon dioxide (CO2) production will be measured.
15762770|NCT04754581|Procedure|Muscle Biopsy|Sample muscle cells from the left leg Vastus Lateralis (thigh) muscle.
15762771|NCT04754581|Procedure|Adipose Tissue Biopsy|Sample fat tissue from the abdomen.
15762772|NCT04754581|Other|Hyperinsulinemic euglycemic clamp|Measurement of insulin sensitivity.
15762773|NCT04754581|Other|PET imaging|After an overnight fast, an intravenous catheter will be placed in each arm (one with arterial line for PET infusion, and the other for infusion of insulin, glucose, and 6,6 D2 glucose tracer. FDG-glucose will be injected followed by 90-minute PET scanning of the thigh.
15762774|NCT04754568|Other|Virtual reality instructional design|60 minute immersive VR experience with branching method information delivery, physical therapy assessment, and diagnosis.
15762775|NCT04754568|Other|Role-playing instructional design|60 minute traditional role-playing with standardized patient
15762776|NCT04754555|Other|Arm Activity Measure (ArmA) in french|The Arm Activity Measure (ArmA) provides a standardized assessment of upper limb passive and active perceived performance
15762777|NCT04754529|Other|Quality-of-Life Assessment|Ancillary studies
15762778|NCT04754529|Other|Survey Administration|Ancillary studies
15762779|NCT04754529|Other|Yoga|Receive yoga intervention
15762780|NCT04754490|Diagnostic Test|Speech Recognition|Speech Recognition
15762781|NCT04754477|Device|Active Osseointegrated Steady-State Implant System (OSI)|System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound process
15762782|NCT04754464|Dietary Supplement|synbiotic|Consumption of 6 g powder consisting of the strains Lactobacillus fermentum K7-Lb1, L. fermentum K8-Lb1, L. fermentum K11-Lb3, acacia gum (gum arabic), maltodextrin, sucralose and flavour twice a day resolved in water
15762783|NCT04754464|Dietary Supplement|microcrystalline cellulose|Consumption of 6 g powder containing microcrystalline cellulose, maltodextrin , sucralose and flavour twice a day, resolved in water
15762784|NCT04754451|Drug|Group L|Attach two lidocaine patches for 12 hours, one above and below the incision site.
15762785|NCT04754438|Behavioral|e-CBT|Electronically delivered cognitive behavioural therapy
15762786|NCT04754438|Behavioral|Mental Health Coaching|Electronically delivered mental health coaching
15762787|NCT04754425|Procedure|Biopsy|Undergo biopsy
15762788|NCT04754425|Procedure|Biospecimen Collection|Undergo collection of blood and bone marrow
15762790|NCT04754412|Other|Behavioral, Psychological or Informational Intervention|Write about stress and coping, emotional disclosure, and benefit finding
15762791|NCT04754412|Other|Behavioral, Psychological or Informational Intervention|Write about positive thoughts and feelings regarding their breast cancer experience
15762792|NCT04754412|Other|Best Practice|Write about facts regarding their cancer diagnosis and treatment
15762793|NCT04754412|Other|Quality-of-Life Assessment|Ancillary studies
15762794|NCT04754412|Other|Questionnaire Administration|Ancillary studies
15762795|NCT04754399|Drug|Cannabidiol (CBD)|"week 1: 25 mg twice daily, approximately 12 hours apart, with food
~week 2: 50 mg twice daily, approximately 12 hours apart, with food
~week 3: 75 mg twice daily, approximately 12 hours apart, with food
~week 4+: 100 mg twice daily, approximately 12 hours apart, with food"
15762796|NCT04754386|Behavioral|Acceptability of OraQuick Advance© Rapid HIV-1/2 Antibody screening Oral fluid-based HIV test|The project offers HIV oral test kits to index parents/caregivers with children eligible for index testing services at facility settings to expand access to HIV testing and treatment services for children, and to ensure that all children who screen positive with an oral fluid-based HIV screening kit are linked to confirmatory testing, and newly diagnosed children are initiated on ART.
15762803|NCT04754347|Device|Computer Aided Detection device|The Computer Aided Detection device, Skout, is designed to help endoscopists detect potential colorectal polyps during colonoscopies. The system performs automated real-time analysis on endoscopic video data to identify potential polyps and produces an informational visual aid around the appropriate sections of the video frames on a display monitor.
15762804|NCT04754334|Drug|ORMD-0801|Oral Insulin
15762805|NCT04754334|Other|Placebo|Fish Oil
15762806|NCT04754321|Radiation|External Beam Radiation Therapy|Undergo EBRT
15762807|NCT04754321|Radiation|Intraoperative Radiation Therapy|Undergo IORT
15762808|NCT04754321|Biological|Pembrolizumab|Given IV
15762809|NCT04754321|Other|Quality-of-Life Assessment|Ancillary studies
15762810|NCT04754321|Procedure|Salvage Surgery|Undergo salvage surgery
15762811|NCT04754308|Diagnostic Test|Spirometry|The method of examination, Spirometry, is non-invasive (i.e. not an intervention that involves penetration into the body by means of incisions or injections.). It is a routine examination and there are no risks, adverse reactions, or discomforts associated with the examination.
15762812|NCT04754295|Other|Goal-Directed Therapy|Administration of fluids and vasoactive drugs guided by non-invasive haemodynamic monitoring
15762813|NCT04754295|Other|STANDARD|Administration of fluids and vasoactive drugs guided by standard vital signs monitoring
15762814|NCT04754282|Other|Position of labouring women for epidural analgesia catheter placement : Traditional Sitting Position (TSP)|"Labouring women admitted to the delivery room of Necker Enfants Malades hospital, requesting an epidural analgesia for labour, and willing to participate in our study will be randomized in the Traditional Sitting Position (TSP) group on odd days or in the Cross-legged Sitting Position (CSP) group on even days.
~Patients in the TSP group seat on the edge of the bed, their feet laid on a support set next to the bed. Patients in the CSP group also seat on the edge the bed, but in a so-called tailor position, their knees bent, their hips flexed and in abduction, their feet under each contralateral thigh.
~The epidural catheter will be placed according to standard local practice in either of the groups."
15762815|NCT04754282|Other|Position of labouring women for epidural analgesia catheter placement : Cross-legged Sitting Position (CSP)|"Labouring women admitted to the delivery room of Necker Enfants Malades hospital, requesting an epidural analgesia for labour, and willing to participate in our study will be randomized in the Traditional Sitting Position (TSP) group on odd days or in the Cross-legged Sitting Position (CSP) group on even days.
~Patients in the TSP group seat on the edge of the bed, their feet laid on a support set next to the bed. Patients in the CSP group also seat on the edge the bed, but in a so-called tailor position, their knees bent, their hips flexed and in abduction, their feet under each contralateral thigh.
~The epidural catheter will be placed according to standard local practice in either of the groups."
15762816|NCT04754269|Behavioral|Beverage Intervention|Parents will watch a video that promotes optimal beverage practices for young children including discouraging consumption of sugar-sweetened beverages and fruit juice and encouraging consumption of water and unsweetened milk. Parents will receive 24 text messages over a 12 week period that reinforce and expand on the messages in the video.
15762817|NCT04754269|Behavioral|Reading Intervention|Parents will watch a video that promotes reading to children and includes specific ideas and techniques for how to make reading interactive and engaging. Parents will receive 24 text messages over a 12 week period that reinforce and expand on the messages in the video.
15762818|NCT04754256|Behavioral|Council of Nutrition Appetite Questionnaire - test for applicability in Danish COPD patients|Council of Nutrition Appetite Questionnaire - test for applicability in Danish COPD patients and for correlation of scores with lung function, CAT-score and other
15762819|NCT04754243|Drug|Gonadotropin|Giving patients gonadotropins and antagonist cetrotide
15762820|NCT04754243|Drug|Standard protocol in IUI|Giving patients gonadotropins without antagonist cetrotide
15762821|NCT04754230|Drug|Tranexamic Acid 1,000 Mg/10 mL (100 Mg/mL) INTRAVEN VIAL (ML)|Medication administered 15 minutes prior to end of surgery.
15762822|NCT04754217|Device|Implant of VAVGJ in native or prosthetic valve|Replacement of the aortic valve and ascending aorta
15762823|NCT04754217|Device|Implant of CAVGJ in native or prosthetic valve|Replacement of the aortic valve and ascending aorta
15762824|NCT04754204|Device|Arrhythmia Management System (AMS)|AMS records rhythm, heart rate, subject-reported symptoms, and multiple parameters that include respiration rate, activity and body posture.
15762826|NCT04754165|Other|Virtual Reality Immersive Relaxation|The VR software developed allows patients to select from scenery such as mountains, the beach or from a selection of short videos, which are intended to promote relaxation.
15762827|NCT04754152|Other|θ burst transcranial magnetic stimulation|In addition to drug therapy, TBS supplementary therapy was given every 3 months.The TBS parameters were as follows: 3 pulses, 50 Hz bursts given every 200 ms (at 5 Hz), and an intensity of 70% of the resting motor threshold, as measured from the right first dorsal interosseous muscle using a handheld 70 mm figure-of-eight coil. Take a course every 10 weeks .
15762828|NCT04754152|Drug|Pharmacotherapy|Stable doses of cholinesterase inhibitors were given and the patients were followed up every three months.
15762829|NCT04754139|Other|WeChat mobile mini-application|Sexual health education and the role of PrEP
15762830|NCT04754126|Behavioral|Amazing Me|The Amazing Me Program is an evidence-based program designed to help children between the ages of 9 and 11 build self-esteem, body confidence, and eliminate weight-based bullying and teasing. This school-based curriculum satisfies national educational health requirements and provides tools for teachers to implement in 4th and 5th grade classrooms.
15762831|NCT04754113|Other|prone position|patient was helped into the prone position, patient received instructions of end expiratory occlusion lasting at least 10 seconds and, 1 seconds after the start, a bolus of 10 mL of 5% NaCl solution was injected via the central venous catheter
15762832|NCT04754100|Drug|agenT-797|"Part 1 agenT-797 is an off-the shelf cell therapy consisting of ≥ 95% allogeneic human unmodified iNKT isolated from 1 healthy donor mononuclear cell apheresis unit and expanded ex-vivo.
~Part 2 agenT-797 is an off-the shelf cell therapy consisting of ≥ 95% allogeneic human unmodified iNKT isolated from 1 healthy donor mononuclear cell apheresis unit and expanded ex-vivo.
~Lymphodepletion:
~The conditioning therapy will be administered prior to agenT-797 infusion. Dose and rate of infusion of the chemotherapy may be adapted as medically indicated."
15762833|NCT04754087|Device|Vivacit-E and Longevity (HXLPE) Liners|This is a dual cohort study in which 150 subjects will receive the Vivacit-E (HXLPE) Liner and 150 subjects will receive the Longevity (HXLPE) Liner.
15762834|NCT04754074|Behavioral|Education|Weekly education related to behavior change
15762835|NCT04754074|Behavioral|Personalized coaching|Weekly calls with personalized coaches in behavior modification, nutrition, and physical activity/exercise.
15762836|NCT04754074|Behavioral|Weekly behavior modification challenges|Weekly challenges to address behavior change
15762837|NCT04754061|Drug|Psilocybin|"Phase 1 (week 1): all enrolled participants will take a single 1mg oral dose of psilocybin once per day on Monday and Thursday. If no adverse events are reported at any point during the week (Mon-Fri), the participant will continue to Phase 2 for week 2.
~Phase 2: The participant will take a single 1mg oral dose of psilocybin once per day for 5 consecutive days (Monday to Friday). If no adverse events are reported at any point during the week (Mon-Fri), the participant will continue to Phase 3 for week 3.
~Phase 3: The participant will take two 1mg oral doses (2mg total) of psilocybin once per day for 5 consecutive days (Monday to Friday). If no adverse events are reported at any point during the week (Mon-Fri), the participant will continue to Phase 4 for week 4.
~Phase 4 (maximum allowable dose): The participant will take three 1mg oral doses (3mg total) of psilocybin once per day for 5 consecutive days (Monday to Friday)."
15762838|NCT04754048|Device|Avance Solo NPWT System|Wound treatment with Avance Solo NPWT System for up to 28 days.
15762839|NCT04754035|Drug|Venetoclax|venetoclax 20 mg, 50 mg, 100 mg
15762840|NCT04754035|Drug|Imbruvica Oral Product|Imbruvica 140 mg
15762841|NCT04754022|Other|Restrictive Transfusion Strategy|Patients will receive a RBC transfusion if their Hb concentration is <75 g/L (<7.5 g/dL; <4.7mmol/L) intraoperatively and/or postoperatively.
15762842|NCT04754022|Other|Liberal transfusion strategy|Patients will receive a RBC transfusion if their Hb concentration is <95 g/L (<9.5 g/dL; <5.9mmol/L) intraoperatively, or postoperatively in the ICU; and/or <85 g/L (< 8.5 g/dL; <5.3mmol/L) on the ward.
15762843|NCT04754009|Behavioral|Trauma-Sensitive Yoga + TAU|Trauma-Sensitive Yoga is a movement-based approach that are used to integrate both mind and body, and promote body awareness and acceptance for those who have been exposed to traumatic events and currently experience trauma symptoms.
15762844|NCT04754009|Behavioral|Chen Style Tai Chi + TAU|Chen Style Practical Method tai chi is a martial art that is used as a form of self-defense and to maintain physical health and well-being.
15762845|NCT04754009|Behavioral|Treatment as Usual|Consists of traditional talk therapy for mental health.
15762846|NCT04753983|Diagnostic Test|Functional magnetic resonance imaging (fMRI)|Diagnostic imaging measuring the metabolic changes that occur within the brain used for measuring and mapping brain activity
15762847|NCT04753970|Drug|Cilostazol|Cilostazol 100mg BID
15762848|NCT04753957|Drug|micronized Progesterone|200mg micronized progesterone placed vaginally
15762849|NCT04753944|Dietary Supplement|Active Comparator: Probiotic|The evaluation of the influence of a probiotics therapy on mood improvement and the reduction of depressive symptoms in women in the perimenopausal age group.
15762850|NCT04753944|Dietary Supplement|Placebo group|Patients will be introduced for 5 weeks with placebo consisting of starch, maltodextrins and vegetable protein. The placebo dose is going to be 4 capsules daily. The treatment will be administered two times a day, during breakfast and supper.
15762851|NCT04753931|Other|Sensory Training in addition to Bobath Training|Trunk-focused exercises will be applied for different senses (tactile, proprioceptive, etc.) in addition to Bobath exercises. Bobath exercises will be determined individually according to the evaluation results. In general, exercises aiming to muscle tone regulation, increase balance, walking, and functionality will be applied. Trunk-focused Bobath exercises will be selected.
15762852|NCT04753931|Other|Bobath Training|Bobath exercises will be determined individually according to the evaluation results. In general, exercises aiming to muscle tone regulation, increase balance, walking, and functionality will be applied. Trunk-focused Bobath exercises will be selected.
15762853|NCT04753918|Drug|Porfimer sodium|Photofrin 2mg/kg was iv injected 48-50 hours before light illumination.
15763172|NCT04751396|Other|Interview|Participate in interview
15762854|NCT04753918|Drug|Ethiodized oil|In hybrid operation room setting, a navigational bronchoscope guide sheath was inserted to the proximal end of the tumor region. About 5 ml Lipiodol was infused to full cover whole the tumor.
15762855|NCT04753918|Procedure|Novel light delivery methods of photodynamic therapy|Using high-refraction index contrast medium: lipiodol as a light diffusor to enhance the range of photodynamic therapy
15762856|NCT04753918|Device|Fiber optic|A cylindrical laser fiber was then inserted through the guide sheath to the tumor region then illuminate light to complete the photodynamic therapy.
15762857|NCT04753892|Other|3SM2-G-CRM197 with squalene adjuvant|Immune challenge agent
15762858|NCT04753879|Drug|Nab-paclitaxel|"Patients will receive treatment Day 1 and Day 15 of each cycle (28 days).
~Nab-paclitaxel (80 mg/m2) will be administered IV on Day 1 and Day 15 (28 day cycle).
~Other Name: Abraxane"
15762859|NCT04753879|Drug|Gemcitabine|"Patients will receive treatment Day 1 and Day 15 of each cycle (28 days).
~Gemcitabine (500mg/m2) will be administered IV on Day 1 and Day 15 (28 day cycle).
~Other Name: Gemzar"
15762860|NCT04753879|Drug|Cisplatin|"Patients will receive treatment Day 1 and Day 15 of each cycle (28 days).
~Cisplatin (20mg/m2) will be administered IV on Day 1 and Day 15 (28 day cycle).
~Other Name: N/A"
15762861|NCT04753879|Drug|Irinotecan|"Patients will receive treatment Day 1 and Day 15 of each cycle (28 days).
~Irinotecan (20 mg/m2) will be administered IV on Day 1 and Day 15 (28 day cycle).
~Other Name: N/A"
15762862|NCT04753879|Drug|Capecitabine|"Patients will receive treatment Day 1-7 and Day 15-21 of each cycle (28 days).
~Capecitabine (500 mg) will be administered orally twice a day on days 1-7 and 15-21 of each cycle (28 days).
~Other Name: Xeloda"
15762863|NCT04753879|Drug|Pembrolizumab|"Patients will receive treatment Day 1 every other cycle (every 6 weeks) (28 days) during maintenance phase.
~Pembrolizumab (400 mg) will be administered IV on day 1 every other cycle (every 6 weeks).
~Other Name: MK-3475; Keytruda"
15762864|NCT04753879|Drug|Olaparib|"Patients will receive treatment on Days 1-21 during the maintenance phase.
~Olaparib (300 mg) will be administered orally twice a day on Days 1- 21 of each cycle (28 days).
~Other Name: Lynparza"
15762865|NCT04753866|Device|Facial scanner|The Bellus3D facial scanner will be used to scan the patient before and after implant rehabilitation in order to produce .obj files that allow 3D comparisons and to obtain discrepancy values regarding lip support.
15762866|NCT04753853|Procedure|Stromal Vascular Fraction injection|intra- and peri-tendon ultrasound-guided injection of Stromal Vascular Fraction
15762867|NCT04753840|Other|Antihypertensive drugs|One of ACEI / ARB, beta blocker, calcium channel blocker, diuretic
15762868|NCT04753840|Other|remote ischemic preconditioning（RIPC）|40 minutes per day, 10 minutes as a cycle (cuff inflated to 200 mmHg and maintained for 5 minutes, then deflated for 5 minutes to start the next cycle)， a total of 4 cycles.
15762869|NCT04753840|Behavioral|lifestyle intervention|Such as changing dietary habits, smoking cessation and alcohol restriction, exercise and so on.
15762870|NCT04753827|Other|Drug eluting stent|Put a Drug eluting stent in the blood vessel
15762871|NCT04753827|Other|Durg coated balloon|Put a Durg coated balloon in the blood vessel
15762872|NCT04753814|Diagnostic Test|Diagostic tests|Selected prognostic factors will be analyzed, among others: demographic data of the patient, physical examination, symptoms, etiology and history of HF, co-morbidities, results of selected laboratory tests, selected electrocardiographic and echocardiographic data, patient's cooperation with the doctor, treatment applied, parameters in the spiroergometric study and distance in 6MWT and subjective assessment of quality of life according to the KCCQ questionnaire.
15762873|NCT04753801|Behavioral|Thinking, writing and imagination|All participants are asked to take some time to think and write about the respective intervention group's content. In some groups (after the writing exercise (approx. 15min)), participants are also asked to imagine that content or engage in a mindfulness activity or recall task for about 5 minutes.
15762874|NCT04753788|Diagnostic Test|PCR|qPCR for T.pallidum
15762875|NCT04753788|Diagnostic Test|LAMP|LAMP assay for T.pallidum
15762876|NCT04753775|Drug|Aloe vera gel|
15762877|NCT04753749|Drug|Shortened DAPT followed by P2Y12 inhibitor monotherapy (cessation of aspirin)|Subjects will receive DAPT during 1 month post procedure, followed by P2Y12 inhibitor monotherapy (cessation of aspirin) for the next 11 months
15762878|NCT04753749|Drug|Standard DAPT|Subjects will receive standard treatment: P2Y12 inhibitor and aspirin (DAPT) during 12 months after procedure
15762879|NCT04753736|Procedure|Intrauterine administration of hCG-activated peripheral blood mononuclear cells|Intrauterine administration of hCG-activated peripheral blood mononuclear cells
15762880|NCT04753723|Combination Product|Gentamycin with Platform Wound Device|Treatment of wounds with gentamycin and covered with platform wound device.
15762881|NCT04753710|Drug|Ocular gel|Instillation
15762882|NCT04753697|Drug|CC-93538|Subcutaneous
15762883|NCT04753697|Other|Placebo|Subcutaneous
15762884|NCT04753658|Drug|lorlatinib|Oral
15762885|NCT04753645|Behavioral|Handwashing stations at the public places and no soap|BRAC has built 1000 handwashing stations in 20 sub-districts from 3 divisions (out of a total of 8 divisions), namely Dhaka, Mymensingh and Khulna, to increase the access of communities to handwashing facilities. In addition to these handwashing stations, there are other supports available in the intervention areas i.e. in-person demonstration, hygiene meetings, and soap distribution from BRAC. However, this group did not receive any soap from the research team.
15762886|NCT04753645|Behavioral|No activities of the HBCC project and also no soap (Pure Control)|In these randomly selected villages, BRAC did not implement any activity of its HBCC project. Also, the research team did not distribute soap to these households
15762887|NCT04753645|Behavioral|Soap distributed but no activities of the HBCC project|In these randomly selected villages, BRAC did not implement any activity of its HBCC project but the research team randomly selected this group for soap distribution.
15762888|NCT04753645|Behavioral|HBCC project and Soap|These households belong to those villages where the HBCC project has been implemented and also received the soap from the research team.
15762974|NCT04752826|Drug|Pembrolizumab 25 Mg/mL Solution for Injection|Pembrolizumab a programmed death receptor (PD-1) blocking antibody administered at 200mg by intravenous (IV) infusions every 3 weeks.
15762975|NCT04752813|Drug|BPM31510|Subjects will receive a weekly, 96-h infusion of BPM31510 for a duration of 8 weeks.
15763274|NCT04750564|Device|EStim|EStim will applied for 10 to 20 minutes.
15762889|NCT04753619|Drug|Niclosamide Oral Tablet|"NCS 2 grams orally loading dose chewable then 1g every 8 hours in the first day, then on the 2nd day 1g x3 for 7 days. [ this means only in the first day 4 gm/d then on the second day 3g/d in 3 divided doses for 7 days]
~If the participant requires mechanical ventilation over the course of the study, NGT may be administered via nasogastric (NG) or orogastric (OG) tube and, if possible, should be administered with a scheduled nasogastric (NG) or orogastric (OG) feeding."
15762890|NCT04753606|Drug|Obicetrapib|tablets
15762891|NCT04753580|Genetic|Stool collection|"The volunteer will receive the stool collection kit as well as the procedure to follow for this collection.
~Treatment of stool after collection:
~The stool will be treated according to the following two procedures:
~i) part of the stool will be sequenced and will be stored as quickly as possible (4 hours maximum) at -80 ° C, 3 separate aliquots of 1 g; ii) the other part will be intended for implantation in rats and must be homogenized in a final concentration of 20% glycerol (2 hours maximum) and then stored at -80 ° C, 3 aliquots of 1 g."
15762892|NCT04753567|Device|nCap pain relief patch|Each participant will be randomly assigned to sham or actual patch. Patches will be worn for 3 weeks. Pain and quality of life will be assessed and compared between groups
15762893|NCT04753567|Device|Sham Patch|Sham patch will be worn for 3 weeks exactly like actual pain patch
15762894|NCT04753554|Device|ORI group|The patient group whose oxygenation will be managed by ORI values. Hyperoxia or hypoxia will be prevented by using also blood gas analysis in critically ill patients.
15762895|NCT04753554|Other|Conventional group|In this patient group oxygenation will be managed as usual, using blood gas analysis.
15762896|NCT04753541|Other|no intervention|this is not an interventional study
15762897|NCT04753528|Device|AuriMod CT01_A|AuriMod CT01 is a wearable medical device for personalised pain treatment through auricular vagus nerve stimulation. AuriMod CT01 is a battery-operated electrical stimulation device, to be placed behind the ear on the neck. AuriMod CT01 connects to three needle electrodes, which are placed in vagally innervated regions of the auricle. It emits electrical signals with a personalized set of stimulation parameters and adjustable amplitude.
15762898|NCT04753528|Device|AuriMod CT01_B|AuriMod CT01 with a fixed set of stimulation parameters and adjustable stimulation amplitude.
15762899|NCT04753528|Device|AuriMod CT01_C|AuriMod CT01 with a fixed set of stimulation parameters and amplitude.
15762900|NCT04753515|Drug|dexmedetomidine combined with midazolam and remifentanil.|Patients in this group will receive a bolus of midazolam 0.03 mg/kg intravenously, and then a loading dose of 0.5 mcg/kg remifentanil and 0.5 mcg/kg dexmedetomidine over 5 min via separate syringe pumps.
15762901|NCT04753515|Drug|propofol combined with midazolam and remifentanil.|Patients in this group will receive a bolus of midazolam 0.03 mg/kg intravenously, and then a loading dose of 0.5 mcg/kg remifentanil and 0.33 mg/kg propoful over 5 min via separate syringe pumps.
15762902|NCT04753502|Procedure|Laparoscopy|laparoscopic removal of pathologic appendix
15762903|NCT04753489|Drug|Rivaroxaban film-coated tablet 10 mg|Rivaroxaban is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 10 mg of rivaroxaban.
15762904|NCT04753489|Drug|Xarelto® film-coated tablet 10 mg|Xarelto® is manufactured by Bayer AG, Germany. Each tablet contains 10 mg of rivaroxaban.
15762905|NCT04753476|Biological|Injection of Secretome-MSCs|"Injection of Hypoxic Secretome-MSCs intramuscular (deltoideus) :
~Day 1: 1 cc every 12 hours
~Day 2: 1 cc every 12 hours
~Day 3: 1 cc every 12 hours"
15762906|NCT04753476|Drug|Standard treatment of Covid-19|Patients will be given Standard treatment of Covid-19 which accordance with National protocol
15762907|NCT04753463|Other|Survey|The on-line questionnaire which assess the subjective feelings of residents of pandemic impact on ophthalmology training programs
15762908|NCT04753450|Other|No intervention|No intervention
15762914|NCT04753424|Procedure|Surgical technique|Description of novel surgical technique using autologous semitendinosus graft as meniscus transplant.
15762915|NCT04753398|Device|Blood Pressure Monitor, medication dispenser, telemonitoring technology|The telemonitoring interference in the telemonitoring arm consists of an automatic blood pressure device and medication dispenser that transmit data to a central platform.
15762916|NCT04753372|Drug|Rivaroxaban 2.5 MG [Xarelto]|rivaroxaban 2.5mg bid on top of ASA for CAD and/or PAD
15762917|NCT04753359|Other|Med|Mediterranean diet
15762918|NCT04753359|Other|WL|Measuring change in weight
15762919|NCT04753346|Other|Physical Activity Level|International Physical Activity Questionnaire
15762920|NCT04753346|Other|Anxiety and Depression Assessment|Hospital Anxiety and Depression Scale
15762921|NCT04753346|Diagnostic Test|Exercise Capacity|6 Minute Walk Test
15762922|NCT04753346|Diagnostic Test|Pulmonary Function Test|Spirometry
15762923|NCT04753346|Diagnostic Test|Cardiopulmonary Fitness Level|Cardiopulmonary Exercise Test
15762924|NCT04753333|Behavioral|Electromyography biofeedback (EMG-BF)|Participants in this group will receive electromyography biofeedback (EMG-BF) guided strength training with patellar taping
15762925|NCT04753333|Behavioral|Sham electromyography biofeedback (EMG-BF)|Participants in this group will receive Sham electromyography biofeedback (EMG-BF) guided strength training without patellar taping
15762926|NCT04753307|Diagnostic Test|Laboratory measurements|Inflammatory and cardiac biomarkers will be measured before surgery, and on the first, second, third and fifth postoperative day
15762927|NCT04753294|Device|Avance Solo NPWT System|Wound treatment with Avance Solo NPWT System for up to 28 days.
15762928|NCT04753294|Device|Avance Solo Adapt NPWT System|Wound treatment with Avance Solo Adapt NPWT System for up to 28 days.
15762929|NCT04753281|Other|Lifestyle counselling|brief psychological intervention, based on the behaviour change whee
15762976|NCT04752813|Other|Vitamin K1|Subjects will receive prophylactic Vitamin K1 at a recommended dose of 10 mg Intramuscularly prior to the beginning of each week of BPM31510 therapy.
15763035|NCT04752280|Radiation|Proton irradiation|proton irradiation applied as follows: 30 x 2 Gy(RBE) 33 x 1,8 Gy (RBE), or 15 x 2,67 Gy (RBE)
15762930|NCT04753268|Behavioral|Noom Healthy Weight Program|"The intervention consists of a curriculum, provided through daily articles that users are encouraged to read; logging features for weight, meals, and physical activity; in-app groups; and a virtual coach, who will communicate with participants via in-app messaging. During the first week of the study, participants will be introduced to the program, the Noom app, and their coach.
~Coaches will use a secure dashboard to monitor patient progress, which is used to increase engagement and motivation. Participants are encouraged to log their weight, physical activity, and meals daily."
15762932|NCT04753216|Biological|Bevacizumab|Given IV
15762933|NCT04753216|Drug|Irinotecan Sucrosofate|Given IV
15762934|NCT04753203|Drug|Alpelisib plus Capecitabine combination|Adding Alpelisib to Capecitabine as a salvage regimen in mCRC with PIK3CA mutation
15762935|NCT04753190|Behavioral|Baseline Sleep Satiation and Phase Stabilization|All participants will be assigned a 9-h sleep opportunity for the first week of the 2-week study. This will ensure that adolescents are not sleep restricted before living in the laboratory during the second week of the study. The 9-h sleep schedule will be individually timed from his/her averaged wake time (± 15 mins) before the study begins. Assigned bedtime will be 9 h before wake.
15762936|NCT04753190|Behavioral|Gradually Shifted Sleep|For all participants, their assigned baseline sleep/wake schedule will gradually shift earlier over 3 days in the laboratory to facilitate the phase advance shift of the circadian system.
15762937|NCT04753177|Drug|Ribocyclib, fulvestrant, triptorelin|Neoadjuvant treatment will last 24 weeks in both groups. A follow-up examination will be carried out every 8 weeks. In the group of combined hormone therapy, repeate cor-biopsy of the tumor is planned to assess the Ki-67
15762938|NCT04753177|Drug|Doxorubicin, cyclophosphamide, paclitaxel|Neoadjuvant treatment will last 24 weeks in both groups. A follow-up examination will be carried out every 8 weeks. In the group of combined hormone therapy, repeate cor-biopsy of the tumor is planned to assess the Ki-67
15762941|NCT04753151|Drug|Tranexamic acid|The study will be designed as a prospective, double-blinded clinical trial, compared to placebo (0.9% saline) in combination with conventional treatment. Patients will receive intravenous administration of 10 mg / kg tranexamic acid or placebo (0.9% saline) for 10 minutes in the 20 minutes prior to the estimated skin incision. Right after the skin incision, a maintenance dose of 1 mg / kg / h of tranexamic acid (or equivalent infusion rate of 0.9% saline) will be started, remaining until the end of the suture of the surgical wound.
15762942|NCT04753138|Device|TotalFill Bioceramic Sealer|It will be used in conjunction with TotalFill® bioceramic impregnated gutta percha points for the obturation of root canals. It is dispensed through a fine disposable syringe into the root canals during obturation.
15762943|NCT04753138|Device|AH+ Sealer|It consists of 2 pastes that are mixed together in equal amounts before it is used in conjunction with gutta percha points for obturation during root canal treatment.
15762944|NCT04753125|Behavioral|follow-up by telephone|The SIM study is a single-centre, randomized, controlled trial with a 12-month follow-up period. The aim is to determine which of the 3 methods of follow-up is the most effective in promoting patient treatment compliance
15762945|NCT04753125|Behavioral|follow-up via a game in a smartphone app|The SIM study is a single-centre, randomized, controlled trial with a 12-month follow-up period. The aim is to determine which of the 3 methods of follow-up is the most effective in promoting patient treatment compliance
15762946|NCT04753125|Behavioral|conventional follow-up by a health professional|The SIM study is a single-centre, randomized, controlled trial with a 12-month follow-up period. The aim is to determine which of the 3 methods of follow-up is the most effective in promoting patient treatment compliance
15762947|NCT04753112|Drug|Sacubitril / Valsartan Oral Tablet [Entresto]|Treatment of Pulmonary Hypertension With Angiotensin II Receptor Blocker and Neprilysin Inhibitor
15762948|NCT04753099|Behavioral|occupation-based coaching|"Occupation based coaching is an intervention proven to be an effective intervention in family-centered practice. OBC is a strength-based approach that emphases collaboration with clients in goals setting and attainment to increase overall health and quality of life. Clients are the central focus of the intervention and generate their own strategies to address goals as part of the coaching process. In their role as coach, the therapists employ techniques such as reflective questioning and comments to support clients in identifying existing routines and rituals that impact goal attainment and to increase knowledge and access to resources that can promote improved caregiver quality of life after a child's diagnoses with T1D. Occupation based coaching can be divided into the following steps: (1) setting goals, (2) exploring options, (3) planning action, (4) carrying out the plan, (5) checking performance, and (6) generalizing(Little et al., 2018, p.2)."
15762949|NCT04753073|Procedure|Non-invasive physical plasma|Treatment with non invasive physical low-temperature plasma
15762950|NCT04753060|Procedure|Waxing|Donor sites of patients skin grafts are waxed prior to surgery for donor harvesting.
15762951|NCT04753047|Other|No intervention|No intervention
15762952|NCT04753034|Drug|TER-101|Active Comparator
15762953|NCT04753034|Drug|Vehicle|Placebo Comparator
15762954|NCT04753021|Other|Exercise|Progressively increasing training load
15762955|NCT04753008|Drug|Dopamine administration|Administration of dopamine (3 mcg/kg/min) as part of cardiac support therapy after the cardiopulmonary bypass. Administration of dopamine is a subject of clinical decision based on the cardiovascular status of the patients.
15762956|NCT04752995|Procedure|osteotomy|osteotomy osteoclasis of upper tibia
15762957|NCT04752982|Behavioral|c-SIGHT intervention|The c-SIGHT active intervention involves grasping, lifting and balancing wooden rods using the unaffected hand. C-SIGHT uses a training mat, three wooden rods of different lengths, a laptop (to run the computer program) and a small motion tracking sensor which records the user's session length and trials completed. The participant's existing television is used to present the program (connected to the laptop).
15762958|NCT04752982|Behavioral|c-SIGHT attentional control|The c-SIGHT attentional control exercises involves grasping and lifting wooden rods from one end using the unaffected hand. Identical to the intervention group, the c-SIGHT attentional control version uses a training mat, three wooden rods of different lengths, a laptop (to run the computer program) and a small motion tracking sensor which records the user's session length and trials completed. The participant's existing television is used to present the program (connected to the laptop).
15762959|NCT04752956|Other|"Total nasal symptom score (TNSS)"|TNSS contains 4 parameters in assessing the severity of allergic rhinitis: nasal congestion, runny nose, nasal itching, and sneezing. Each symptom is scored out of 4 points, from 0 to 3. 0, none- there are no complaints 1- mild- any symptom that exists but is not particularly annoying; 2, moderate, - any annoying symptom but does not interfere with daily activities or sleep; 3, severe - any symptom preventing daily activities or disturbing during sleeping. The total score is calculated by summing all the scores of 4 fields, which vary ranges from 0 to 15 .In our study, all patients will be instructed to record their TNSS symptom scores on their diary cards each morning before taking the drug. Patients will be graded on baseline TNSS parameters compared to 4 weeks before starting treatment.
15762960|NCT04752956|Behavioral|"Paediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ)"|"PRQLQ, is a self-administered, disease-specific questionnaire, evaluating physical, emotional, and social status of individuals with AR. It contains 23 items in 5 domains: nose symptoms (RS), eye symptoms (ES), practical problems (PF), activity limitation (RL) and other symptoms (OS). One score is given to each domain. 7-point scale (from 0, not problematic; to 6, very problematic). The overall score is derived from the average score of all items (20). In our study, the Turkish validated form of PRQLQ was used
~Patients will be asked to answer PRQLQ questions at the end of each week during treatment. At the end of the treatment, an average of 4 weeks will be taken as the PRQLQ score. Basal PRQLQ questions will be evaluated by the participants based on 4 weeks prior to treatment."
15762961|NCT04752956|Diagnostic Test|Nasal cytology|In anterior rhinoscopy, nasal cytology will be scraped off the middle part of the lower turbinate with the help of a small sterile cotton swab. The cellular material obtained will be fixed by air drying on a glass slide and then stained by the May-Grünwald-Giemsa method. Preparations that do not contain respiratory epithelium or contain less than 10 epithelium at high magnification will be excluded from the study. A percentage of cells per 100 cells will be reported. NECs (nasal eosinophilic count) will be evaluated according to the quantitative classification of Gelardi et al. An experienced cytologist who is blind to the study groups will perform this test. Eosinophil percentages in nasal smears of all patients will be evaluated before and after the treatment.
15762962|NCT04752956|Diagnostic Test|anterior rhinomanometry|Children's right, left and total nasal airway resistance (NAR) and nasal airflow (NAF) will be measured with active anterior rhinomanometry ZAN 100 USB Rhinomanometry (Longmont, Colo., USA). In the evaluation, the NAR- pressure difference / air flow (R = P / V) formula will be used at a constant 150 Pascal prescribed by the European Rinomanometry Standardization Committee in 1984. After the patient is rested for 20 minutes, measurements will be made at 20-22 ° C and the nasal secretion will be cleared. NAR and NAF values of the participants will be measured before starting treatment and 4 weeks after treatment.
15762963|NCT04752943|Other|Tips By Text Messages|Texts sent to caregivers meant to increase parent child interaction around literacy, sent to participants 3 x a week for 7 months
15762964|NCT04752930|Diagnostic Test|ctDNA monitoring|Patients who undergoing radical surgery for colorectal cancer for 6~12 months and with 2 consecutive positive ctDNA testing results within 1 month will be enrolled, and diagnostic laparoscopy will be performed immediately after enrollment. Patients with positive peritoneal metastasis (PCI score <20) will be treated with CRS+HIPEC. Tumor markers, endoscopic and imaging examinations, and ctDNA monitoring will be performed every 3 months in patients with negative peritoneal metastasis. Laparoscopy will be performed when imaging suggested peritoneal metastasis (oligometastases). Re-diagnostic laparoscopy will be performed 24 months after radical surgery when there is no radiographic evidence of recurrence or metastasis. Follow-up time will up to 36 months after colorectal cancer surgery.
15762965|NCT04752930|Diagnostic Test|Imageology|Patients who undergoing radical surgery for colorectal cancer for 6~12 months and with 2 consecutive positive ctDNA testing results within 1 month will be enrolled. and there will be no need to conduct endoscopic exploration immediately after enrollment. Tumor markers, endoscopic and imaging examinations, and ctDNA monitoring will be performed every 3 months until imaging suggested peritoneal metastasis (oligometastases). Patients with positive peritoneal metastasis (PCI score <20) will be treated with CRS+HIPEC. Re-diagnostic laparoscopy will be performed 24 months after radical surgery when there is no radiographic evidence of recurrence or metastasis. Follow-up time will up to 36 months after colorectal cancer surgery.
15762966|NCT04752917|Device|Noise Cancelling headphones|Use of headphones playing patients choice of music
15762967|NCT04752904|Device|ClearSight System|Non-invasive, continuous blood pressure is monitored using ClearSight Sytem
15762968|NCT04752891|Other|AOM diagnosis with app|the diagnosis made by a senior physician using a traditional otoscope. the diagnosis made by the junior physician using an otoendoscope fixed on a connected smartphone
15762969|NCT04752891|Other|AOM diagnosis without app|the diagnosis made by a senior physician and by the junior physician, using a traditional otoscope
15762970|NCT04752878|Diagnostic Test|Ottawa sitting scale|The Ottawa Sitting Scale is a performance-based balance measurement consisting of 10 items that aims to evaluate the sitting balance in a comprehensive, specific, efficient and functional manner.
15762971|NCT04752852|Drug|Dexamethasone|8 mg/2 ml dexamethasone IV, 60 minutes before the induction of anaesthesia
15762972|NCT04752852|Drug|Placebo|2 ml normal saline (0.9%) IV, 60 minutes before the induction of anaesthesia
15762973|NCT04752826|Drug|BI-1808|BI-1808, a fully human immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that targets TNFR2 administered at different dose [Phase I, Part A] and at Recommended Dose for Part B [Phase I, Part B and Phase IIa] by intravenous (IV) infusions every 3 weeks.
15828672|NCT04215120|Drug|Epoetin Alfa|Epoetin Injection
15762977|NCT04752813|Drug|Temozolomide (TMZ)|After 2 wk of treatment with BPM31510 (ie, on Day 15), subjects will start concurrent TMZ 75 mg/m2 once daily (qd) × 42 days. Subjects will receive the standard TMZ treatment for additional 6 cycles post BPM31510 treatment.
15762978|NCT04752813|Radiation|Radiation|After 2 wk of treatment with BPM31510 (ie, on Day 15), subjects will start concurrent standard RT for 42 days.
15762979|NCT04752800|Device|Direct Current Transcranial Stimulation - tDCS|Intervenção Ativa
15762980|NCT04752800|Device|Sham Intervention|Direct Current Transcranial Stimulation - Sham Intervention
15762981|NCT04752787|Other|Online breastfeeding training|Online breastfeeding training will be provided to pregnant women expecting twin babies.
15762982|NCT04752787|Other|QR code supported online breastfeeding training|QR code supported online breastfeeding training will be given to pregnant women who are expecting twin babies.
15762983|NCT04752774|Biological|IPN10200|Powder and solvent for solution for injection
15762984|NCT04752774|Drug|Placebo|Powder and solvent for solution for injection
15762985|NCT04752774|Biological|Dysport|Powder for solution for injection
15762986|NCT04752761|Behavioral|Extrambulatory digital PROMs detection|An alternative PROMs evaluation method will be used in which the questionnaire will be administered to the patient digitally (Google Forms) in an outpatient environment
15762987|NCT04752748|Drug|Drug protocol|"The following drug scheme was carried out: The patients began with methotrexate (MTX) 15 mg / week, which was increased to 25 mg / week until week 12. Subsequent steps for patients with an insufficient response (DAS28 score> 3.2 and the Physician's Global Assessment (PGA)> 4.0 [0-10 cm]) were leflunomide 20mg / day with MTX 15 mg / week from week 12 to week 24 and adalimumab twice a month and MTX 15mg / week from week 24 to week 48. The use of 5mg folic acid was advised once a week during the 48 weeks of the study. Three treatment failures were considered over these 48 weeks:
~Failure 1: failure of the first DMARD (MTX) in week 12.
~Failure 2: failure of the second DMARD (leflunomide) at week 24
~Failure 3: failure of the first immunobiological (adalimumab) at week 48."
15762989|NCT04752722|Drug|EG-70|Patients will receive one cycle of EG-70 administered as a bladder instillation of a 50 mL volume of study drug via catheter with a targeted retention time of 60 minutes. One cycle is defined by 2 intravesical administrations separated by 1 week, and followed by another 10 weeks (1 cycle lasts approximately 12 weeks).
15762990|NCT04752722|Drug|EG-70|Patients will receive up to 4 cycles of EG-70 administered as a bladder instillation of a 50 mL volume of study drug via catheter with a targeted retention time of 60 minutes. One cycle is defined by 2 intravesical administrations separated by 1 week, and followed by another 10 weeks (1 cycle lasts approximately 12 weeks).
15762991|NCT04752709|Device|ELITONE UUI|External electrical stimulation
15762992|NCT04752696|Drug|Onvansertib|Oral capsule
15762993|NCT04752696|Drug|Nanoliposomal irinotecan|Intravenous infusion
15762994|NCT04752696|Drug|Leucovorin|Intravenous infusion
15762995|NCT04752696|Drug|Fluorouracil|Intravenous infusion
15762996|NCT04752683|Other|MyBuddy Employee Wellbeing App|"The intervention is not being evaluated in this research study.
~The MyBuddy app contains five core components to help employees track their wellbeing (assisting employers in managing their employees' wellbeing). The six core components are: (1) a 'Budometer' stress measure (measure to be validated); (2) working from home information and assessment designed to inform employees about the legal requirements and risks they and their employers are subject to when home working; (3) messaging service for employees to contact their HR department or their line manager; (4) a 'Think Room' forum for staff to discuss ideas; (5) an 'Appreciation Page' for staff to show appreciation for their colleagues; and (6) 'my hours this week' log to track the hours they have worked. A seventh element is available for HR departments demonstrating data for the employees (employees are aware that HR will be able to see their data)."
15762997|NCT04752657|Other|Delayed administration of survey modules|The intervention consists in delaying the administration of the physical function, physical activity, and events survey modules by 2 weeks
15762998|NCT04752657|Other|Regular administration of survey modules|The physical function, physical activity, and events survey modules are administered according to the regular pattern
15762999|NCT04752644|Biological|MVA-mBN294B|MVA-BN-RSV (nominal titre 5 x10*8 Inf.U per 0.5 mL) as intramuscular injections. Liquid frozen suspension, single dose of 0.5ml.
15763000|NCT04752644|Drug|Placebo|TBS (Placebo) as intramuscular injections (0.5ml)
15763001|NCT04752631|Drug|Tenecteplase|The participants received TNK-tPA thrombolytic therapy
15763002|NCT04752618|Behavioral|P-STAIR|PCIT+ STAIR
15763003|NCT04752618|Behavioral|Supportive Counseling|Non-trauma focused psychotherapy
15763004|NCT04752605|Behavioral|Finnish ENGAGE together|Early childhood education workers play games with children during day care. The games (e.g. ball games, puzzles, Simon says) target children's executive functions and self-regulatory skills, e.g. inhibition, attention, and emotion regulation. The first phase of the intervention (6 weeks) includes play sessions (15 minutes each day) for all children as well as a parents' evening to encourage playing at home. In the second phase (8 weeks), more individualized small group play sessions (3 times a week, 30 minutes at once) are arranged for the children that show difficulties in self-regulation after the first phase. Also, a parents' group including 6 group sessions and 2 phone calls is arranged for their parents in this phase. The participating parents are asked to play the games for 20 minutes each day with their children. During the group meetings, the parents share their experiences of playing at home and receive support and guidance from 2 health care professionals.
15763005|NCT04752592|Diagnostic Test|SeroSelectTB rapid TB test|The SeroSelectTB test is a rapid blood-based immunochemical lateral flow assay for the detection of active tuberculosis.
15763032|NCT04752319|Device|BreEStim|BreEStim will be applied for 10 to 20 minutes per session for multiple sessions
15763033|NCT04752319|Device|EStim|EStim will be applied for 10 to 20 minutes per session for multiple sessions
15763034|NCT04752306|Other|Interviews|Semi-structured interviews will take place between June and August 2020. Eight individual interviews with healthcare workers, ten individual interviews with residents and two individual interviews with policymakers. Interviews with the healthcare workers and policymakers will take place in a meeting room at the nursing home of employment. One interview with a policymaker will take place online. Interviews with residents will be hold in their personal room.
15763006|NCT04752579|Other|Pilates exercise program|"The program will be individually supervised and will be conducted twice a week at the physiotherapy center.
~• Slow execution of 7-10 repetitions of the following Pilates exercises: Pelvic Curl, Pilates Single Legs Lifts & Leg Change, Twist Supine Pilates exercise, Chest Lifts Pilates Exercise, Chest Lift with Rotation Pilates exercise, 100's Prep Pilates Exercise, Single Leg Stretch Pilates Exercise, Front Support Pilates Exercise and Basic Back Extension Pilates Exercise. After the 6th week, while the person will be familiar with the basic exercises of the Pilates method the following exercises will be added: Leg Pull Front, Side Bend Pilates Exercise, Sphinx - Abdominal Lift Pilates Exercise, Shoulder Bridge Prep Pilates and Shoulder Bridge Pilates Exercise. Each session will be completed with breathing exercises and stretching exercises of the torso and lower limbs for 5 minutes."
15763007|NCT04752566|Biological|Eculizumab|Eculizumab will be administered via IV infusion once a week for 4 weeks.
15763008|NCT04752566|Drug|Placebo|Placebo will be administered via IV infusion once a week for 4 weeks.
15763009|NCT04752540|Drug|Olorofim|single oral dose
15763010|NCT04752527|Drug|venetoclax combined with decitabine|combination of venetoclax plus decitabine, and sorafenib for patients with high FLT3-ITD allelic ratio. (On day 1 of cycle 1, decitabine 20 mg/m2 will be given intravenously, and will continue for 5 days. Simultaneously the patient will start out with Venetoclax 100mg and progress to 400mg until the 28 day cycle is finished. For patients with high FLT3-ITD allelic ratio, sorafenib was administered at a dose of 400mg orally twice daily, on days 3 through 28.
15763011|NCT04752501|Other|Psychologically Informed Education|This arm will provide an education intervention which will attempt to address maladaptive psychological behaviors in adolescents with knee pain
15763012|NCT04752501|Other|Biomedical Education (Control)|This arm will provide education of basic knee anatomy, lower extremity mechanics, and simple exercises and will not address maladaptive psychological behaviors
15763013|NCT04752488|Other|Telerehabilitation (TR)|The home exercise program will be educated to the patient on the first day. Exercises for isometric and isotonic strengthening, stretching, and stabilization of the neck muscles will be given. Exercises will be presented to the patients in audio-video format and detailed instructions with explanations. The exercise protocol will also be the same as in the conventional rehabilitation group. Patients will be asked to do the exercises once a day for 8 weeks and 10 repetitions each.
15763014|NCT04752488|Other|Conventional Rehabilitation (CR)|The home exercise program will be educated to the patient on the first day. Isometric and isotonic strengthening, stretching and stabilization exercises for the neck muscles will be given. Exercise information form including explanation and picture of the exercises will be given to the patients. Patients will be asked to do the exercises once a day for 8 weeks and 10 repetitions each.
15763015|NCT04752475|Drug|Furosemide|Furosemide 20 mg pill taken daily for 5 days
15763016|NCT04752475|Other|Placebo|Identical-appearing placebo pill taken daily for 5 days
15763017|NCT04752462|Behavioral|Telemedicine Intensive Motivational Enhancement|Participants will attend a telemedicine motivational enhancement visit to improve PAP adherence along with regular follow up for sleep apnea
15763018|NCT04752449|Behavioral|Virtual Cognitive Behavioural Therapy for Psychosis|CBT will be delivered according to an established manual that the PI has previously used successfully for in-person treatment. Treatment will consist of individual sessions with a psychologist employed by the University of Toronto for 1-hour per week for 6-months, or by one of the listed clinical graduate students under his supervision. All treatment will be delivered virtually in the participant's home using the online platform Zoom which is PHIPA/PIPEDA compliant. If participants do not have the technology required for virtual sessions, then a tablet will be loaned to them for the duration of treatment. This treatment will be delivered in addition to usual care and no changes to usual care will be required.
15763019|NCT04752436|Behavioral|Supra high intensity interval training|The exercise program will consist of eight 20-second all-out exercise bouts followed by 10 seconds of rest for a total of 4 minutes of total exercise duration. The intensity of exercise is all out. The exercise will be conducted 3 times a week for 8 weeks.
15763020|NCT04752423|Other|Pre operative assessment|"Anxiety assessment : Numeric rating scale (patient and caregiver), APAIS scale (patient), Covi Scale (Caregiver)
~Verbalization : anesthesia-related concerns (expressed by patient and considered by caregiver)"
15763021|NCT04752410|Procedure|Selective Brachial Plexus Block|It is one type of peripheral nerve blocks for upper extremity surgery. In this study, the block will be done under the ultrasound guidance and the local anesthetic agent (a mixture of 2% Xylocaine with 1:200,000 adrenaline and 0.5% Chirocaine in a total of 25ml) will be injected at the trunks of the brachial plexus in order to produce the surgical anesthesia of the whole upper extremity of the patients scheduled for upper limb surgeries.
15763022|NCT04752384|Drug|Buprenorphine|Transdermal buprenorphine will be started at 5 mcg/hr once a week. Depending on the Visual Analog Scale (VAS) score, it may be increased up to 20 mcg/hr once a week.
15763023|NCT04752384|Drug|Tramadol|Oral tramadol will be started at 50 mg/day. Depending on the Visual Analog Scale (VAS) score, it may be increased up to 400 mg/day.
15763024|NCT04752384|Device|Oral Mucositis (OM) Pain App|"Each study participant will be issued an Android smartphone, or he or she may use his/her own compatible device (whether or not it has an active data service) to which the OM Pain App will be downloaded and installed. Subjects will receive a preprogrammed alarm four times a day from their smartphones prompting them to directly enter OM pain levels on the device. Patients may submit as many pain entries as they wish beyond the four minimum levels.
~Subjects will receive a preprogrammed alarm four times a day from their smartphones prompting them to directly enter OM pain levels on the device. Patients may submit as many pain entries as they wish beyond the four minimum levels."
15763027|NCT04752345|Other|Pharmacoinvasive strategy|Pharmacoinvasive treatment [full-dose fibrinolysis combined with rescue PCI (in case of failed fibrinolysis) or routine early PCI (3 to 24 hours, in case of successful fibrinolysis)
15763028|NCT04752345|Other|Reduced-dose facilitated PCI strategy|Reduced-dose facilitated PCI[reduced-dose fibrinolysis,simultaneously transfer,immediate coronary angiography and andioplasty when arrived at PCI center(<3 hours)]
15763036|NCT04752280|Radiation|Photon irradiation|proton irradiation applied as follows: 30 x 2 Gy 33 x 1,8 Gy, or 15 x 2,67 Gy
15763037|NCT04752267|Procedure|Computed Tomography|Undergo PET/CT
15763038|NCT04752267|Drug|18F-FMAU|Given IV
15763039|NCT04752267|Procedure|Multiparametric Magnetic Resonance Imaging|Undergo mpMRI
15763040|NCT04752267|Procedure|Positron Emission Tomography|Undergo PET/CT
15763041|NCT04752241|Procedure|Inferior Mesenteric Artery Preservation|Performing left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries.
15763042|NCT04752241|Procedure|Inferior Mesenteric Artery Ligation|Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery
15763043|NCT04752228|Other|Philadelphia ACE Survey|The Philadelphia ACE survey assesses the three major domains featured within the original ACE Study Questionnaire developed by Felitti et al. (abuse, neglect, and family dysfunction), in addition to five community-level stressors.
15763044|NCT04752228|Other|Lifestyle Assessment|The Lifestyle Assessment questionnaire features the Short Form (36) Health Survey, Patient Health Questionnaire-9, General Anxiety Disorder-7 questionnaire, Seattle Angina Questionnaire-7, and modified Perceived Need for Card Questionnaire, which are validated questionnaires for the assessment of quality of life, depression, anxiety, angina, and perceived need for care, respectively.
15763045|NCT04752215|Drug|BI 765049|BI 765049
15763046|NCT04752215|Drug|BI 754091|BI 754091
15763047|NCT04752202|Behavioral|Individually balanced elimination/reducing diets|Participants received diets in the range of 1400-1600 kcal/day (with a deficit of about 1000 kcal/day, depending on the resting metabolism and energy expenditure during the day). At the initial visit and every subsequent month, the women received individually balanced elimination/reducing diets, in accordance with the previously performed food sensitivity tests for 6 months. Laboratory tests for type III food sensitivity in the IgG1-3 class using the ELISA method were performed in an accredited medical laboratory. Diets were designed by a qualified dietitian using the Aliant (Poland) diet calculator. Each diet had the same macronutrient content - 25% protein, 30% fat, and 45% carbohydrate, and met the daily requirements for micro and macro elements for the given age group.
15763048|NCT04752202|Behavioral|Individually balanced reducing diets (without elimination)|Participants received diets in the range of 1400-1600 kcal/day (with a deficit of about 1000 kcal/day, depending on the resting metabolism and energy expenditure during the day). At the initial visit and every subsequent month, the women received individually balanced reducing diets (without elimination) for 6 months.Diets were designed by a qualified dietitian using the Aliant (Poland) diet calculator. Each diet had the same macronutrient content - 25% protein, 30% fat, and 45% carbohydrate, and met the daily requirements for micro and macro elements for the given age group.
15763049|NCT04752189|Behavioral|Enhanced Replicating Effective Programs (Enhanced REP)|Deploy Enhanced REP to optimize the delivery of a drug use prevention intervention in community schools and test its feasibility, acceptability, and appropriateness; Enhanced REP includes tailoring the curriculum, training, and providing ongoing provider consultation, or facilitation, to support implementation.
15763050|NCT04752189|Behavioral|Standard implementation|Standard implementation of the Michigan Model for Health is akin to Standard REP and includes the curriculum materials, standard training and as-needed technical assistance.
15763051|NCT04752176|Device|ØREBLUE® Method|"The ØREBLUE® Method combines 2 inseparable therapeutic approaches that will be personalized, one dedicated to the auditory symptom (personalized sound therapy based on music and delivered through a helmet as part of the device), the other dedicated to the psychology of the subject.
~Sound rehabilitation will be based on successive treatment sequences. The 1st sequence includes 30 hours of listening, at a rate of 2 hours / day, 5 days a week. A period of 4 to 6 weeks is necessary before carrying out a new sequence. The second sequence (and subsequent ones when necessary, respecting a 4-to-6-weeks window in between) of sound rehabilitation consists of 20 hours distributed as for the first sequence."
15763052|NCT04752163|Drug|DS-1594b|Given DS-1594b PO
15763053|NCT04752163|Drug|Azacitidine|Given IV or SC
15763054|NCT04752163|Drug|Cyclophosphamide|Given IV
15763055|NCT04752163|Drug|Cytarabine|Given IT
15763056|NCT04752163|Drug|Dexamethasone|Given PO or IV
15763057|NCT04752163|Biological|Filgrastim|Given SC
15763058|NCT04752163|Drug|Leucovorin|Given IV or PO
15763059|NCT04752163|Drug|Mesna|Given IV
15763060|NCT04752163|Drug|Methotrexate|Given IT
15763061|NCT04752163|Drug|Posaconazole|Given PO
15763062|NCT04752163|Drug|Prednisone|Given PO
15763063|NCT04752163|Biological|Rituximab|Given IV
15763064|NCT04752163|Drug|Venetoclax|Given PO
15763065|NCT04752163|Drug|Vincristine|Given IV
15763066|NCT04752163|Drug|Voriconazole|Given PO
15763067|NCT04752150|Other|Analgesia management; group ESPB and RIB|Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
15763068|NCT04752137|Drug|Indocyanine green|The SPY PHI and its dye Indocyanine Green dye (ICG) is a non-invasive device that is connected to a light source tower that is already available in the hospital in the operating room under Gynecology and Obstetrics Equipment. This is a special light source lamp that allows to test for vascularity in the soft tissues intraoperatively. Previous research in animal models proved the concept that the increased vascularity in tumors can be used to use this device to improve intraoperative assessment of tumor margins during resection. Our study will help to establish a correlation between activity with the dye and histological findings. This information has the potential to help sarcoma patients by avoiding staged surgeries, decreasing hospitalization times, and decreasing the likelihood of local recurrence by improving margin quality.
15763098|NCT04751903|Behavioral|oral motor stimulation|Oral motor stimulation (OMS) is defined as the sensorial stimulation of cheek, lip, jaw, upper-lower gum, internal cheek, tongue and soft palate that affects the physiology of oropharyngeal mechanisms and develops feeding functions.It took 15 minutes to apply the OMS by lightly touching their cheeks, lips, gums, and tongue with fingertips for the first 12 minutes, followed by letting the infant suck on a pacifier for the remaining 3 minutes. OMS used as an alternative or supplementary early intervention strategy to develop oral feeding skills in preterm infants.
15763069|NCT04752137|Device|SPY-PHI|The SPY PHI and its dye Indocyanine Green dye (ICG) is a non-invasive device that is connected to a light source tower that is already available in the hospital in the operating room under Gynecology and Obstetrics Equipment. This is a special light source lamp that allows to test for vascularity in the soft tissues intraoperatively. Previous research in animal models proved the concept that the increased vascularity in tumors can be used to use this device to improve intraoperative assessment of tumor margins during resection. Our study will help to establish a correlation between activity with the dye and histological findings. This information has the potential to help sarcoma patients by avoiding staged surgeries, decreasing hospitalization times, and decreasing the likelihood of local recurrence by improving margin quality.
15763070|NCT04752124|Other|Exercise Therapy|High intensity speed based interval treadmill training
15763071|NCT04752124|Other|conventional therapy|conventional physical therapy
15763072|NCT04752111|Drug|Esmolol|administration of a loading dose esmolol infusion 0.5 mg/kg in 30 ml isotonic saline in the IV line, followed by an IV infusion of esmolol 0.05 mg/kg/min till the completion of surgery
15763073|NCT04752098|Diagnostic Test|Vibro-acoustic analysis (VAA), based on ultrasound radiation force|The study will develop and validate a new ultrasonic method for assessment of infant bone by evaluating structural and mechanical characteristics of the infant tibia. This project will utilize a novel, non-invasive method, vibro-acoustic analysis (VAA), to evaluate infant bone properties in a wide frequency range while reducing the artifacts from soft tissue.
15763074|NCT04752085|Diagnostic Test|Chitotriosidase activity|The chitotriosidase activity will be measured in all the subjects
15763075|NCT04752072|Behavioral|Enhanced Skills Training in Affective and Interpersonal Regulation|"The first (formulation) session enables linking present difficulties and traumatic events, identifying current issues/concerns, and collaboratively agreeing on the order of modules based on symptom severity and client readiness.
~The PTSD module provides narrative exposure to the traumatic memories and targets re-experiencing, avoidance and hyperarousal symptoms. The AD module focuses on identifying and labelling feelings, emotion management, distress tolerance, acceptance of feelings and experiencing positive emotions. The NSC module focuses on staying in the present moment and combating dissociation; self-compassion and mindfulness skills; challenging thinking patterns and developing a balanced view of self. The DR module focuses on exploring and revising maladaptive schemas; effective assertiveness; awareness of social context; and flexibility in interpersonal expectations and behaviours displayed in social interactions."
15763076|NCT04752072|Behavioral|Treatment as usual|The first session will involve a mental health assessment by either a psychiatrist or psychologist. A treatment package will be developed based on the information collected during the assessment. Details of the interventions delivered to each participant receiving TAU, which will include elements of psychoeducation, symptom-management and trauma-focused cognitive behaviour therapy, will be recorded.
15763077|NCT04752059|Drug|Trastuzumab deruxtecan|Trastuzumab-deruxtecan 5.4 mg/kg body weight i.v. on day 1 once every three weeks until progression or death
15763078|NCT04752046|Procedure|maxillary cancer resection|patient with maxillary cancer will resected and reconstructed
15763079|NCT04752033|Drug|Morphine|Dose titration utilizing will be done using sequential up and down design using biased coin method. All participant will receive a morphine dose that is within the range of doses currently utilized clinically and no participant will receive placebo only.
15763080|NCT04752033|Drug|Hydromorphone|Dose titration utilizing will be done using sequential up and down design using biased coin method. All participant will receive a hydromorphone dose that is within the range of doses currently utilized clinically and no participant will receive placebo only.
15763081|NCT04752020|Drug|Netarsudil Ophthalmic|Use of netarsudil after Descemetorhexis without endothelial keratoplasty
15763082|NCT04752007|Radiation|CT or RSA; SI joint movement: stright leg raise with 1 kg load|Measurement of the SI joint movement in mikrometer
15763083|NCT04752007|Radiation|CT or RSA; SI joint movement: One side figure of four position with 1 kg load|Measurement of the SI joint movement in mikrometer
15763084|NCT04752007|Radiation|CT or RSA; SI joint movement: supine position|Baseline position
15763085|NCT04751994|Dietary Supplement|Iron drops/Ferrous sulphate|participant will consume daily drops of iron
15763086|NCT04751994|Dietary Supplement|Placebo drops|Participants will consume daily drops of placebo
15763087|NCT04751981|Procedure|Patient Specific Guide|For lumbar fusion pedicle screws will be placed with the aid of patient specific guides.
15763088|NCT04751981|Procedure|Navigation|Conventional navigation will be used to place pedicle screws.
15763089|NCT04751968|Other|Group Intervention|The intervention will consist of 6 psycho-educational group sessions for caregivers and 6 psycho-educational group sessions for adolescents. Adolescent and caregiver sessions will be held separately and will focus on different issues. Adolescents are taught skills for coping and relating more effectively with others. Caregivers learn about adolescent development, effective parenting and the importance of connection. The groups consist of 6 stand-alone modules permitting rolling entry and prompt access. Youth and Caregivers will receive a weekly text message reminder of their exit assessment date/time, homework from that week's intervention group and crisis resources.
15763090|NCT04751968|Behavioral|Enhanced Treatment as Usual|Youth and Caregivers will receive a weekly text message reminder of their exit assessment date/time, a mental health tip and crisis resources.
15763091|NCT04751955|Drug|Olinvacimab added to Capecitabine|Olinvacimab: IV weekly administration In phase lb, 12mg/kg and 16mg/kg weekly IV will be tested. In phase ll, the RP2D in phase lb will be used. Capecitabine: fixed dose as an oral administration, 1250mg/m2 BID on day 1 to 14 followed by 7 days off
15763094|NCT04751929|Drug|Abemaciclib|Taken orally 2x daily
15763095|NCT04751929|Drug|Atezolizumab|Intravenously Day 1 of 21 day cycle
15763096|NCT04751916|Dietary Supplement|Essential Amino Acid Protein Supplement|Proprietary essential amino acid protein supplement
15763097|NCT04751916|Dietary Supplement|Beneprotein®|Whey protein supplement
15763099|NCT04751890|Behavioral|Structured home-based exercise|Low-intensity interval walking program prescribed at hospital and performed at daily at home
15763100|NCT04751890|Behavioral|Walking advice|Walking advice according to the guidelines for peripheral artery disease patients
15763101|NCT04751877|Drug|Isatuximab|Isatuximab by IV route, per 28 days cycle - Cycle1: 10 mg/kg on days 1, 8, 15, and 22. Cycles 2 to 12: 10 mg/kg on days 1 and 15. From cycle 13: 10 mg/kg on day 1.
15763102|NCT04751877|Drug|Lenalidomide|Lenalidomide by oral route, per 28 days cycle - 25 mg daily on days 1-21.
15763103|NCT04751877|Drug|Bortezomib|Bortezomib sub-cutaneous, per 28 days cycle - Cycles 1 to 12: 1.3 mg/m2 on days 1, 8, 15. Cycles 13-18: 1.3 mg/m2 on days 1, 15.
15763104|NCT04751877|Drug|Dexamethasone|Dexamethasone by oral route, per 28 days cycle - 20 mg daily on days 1, 8, 15 and 22.
15763105|NCT04751864|Device|Cranial Electrotherapy Stimulator (CES) Device|Fisher Wallace Cranial Electrotherapy Stimulator (CES) Device
15763106|NCT04751851|Behavioral|Medium duration withdrawal programme with ACT|"10 interviews of withdrawal monitoring and psychological support during a taper programme of 6 weeks.
~8 individual weekly ACT sessions. The ACT programme includes mindfulness, acceptance and thoughts defusion exercises, identification of personal values and promotion of actions committed to these values. It also includes sleep restriction, a component of CBT for insomnia, used in this protocol to carry out committed-actions, according to the principles of ACT."
15763107|NCT04751851|Behavioral|Long duration withdrawal programme with ACT|"10 interviews of withdrawal monitoring and psychological support during a taper programme of 18 weeks.
~8 individual weekly ACT sessions. The ACT programme includes mindfulness, acceptance and thoughts defusion exercises, identification of personal values and promotion of actions committed to these values. It also includes sleep restriction, a component of CBT for insomnia, used in this protocol to carry out committed-actions, according to the principles of ACT."
15763108|NCT04751851|Behavioral|Medium duration withdrawal programme without ACT|10 interviews of withdrawal monitoring and psychological support during a taper programme of 6 weeks.
15763109|NCT04751851|Behavioral|Long duration withdrawal programme without ACT|10 interviews of withdrawal monitoring and psychological support during a taper programme of 18 weeks.
15763110|NCT04751838|Other|no intervention|no intervention
15763111|NCT04751825|Behavioral|I-EAET|See information in arm description.
15763112|NCT04751812|Procedure|High-pain extra|"Paracetamol, Etoricoxib, Oxycodone, Ondansetron po. Betamethasone 4 mg iv.
~Anesthesia:
~As standard + bolus esketamine 0.25 mg/kg iv + Clonidine 1 µg/kg i.v.
~Postoperative pain treatment:
~At pain NRS ≥ 4 - 5 mg of oxycodone i.v. Paracetamol will be administered every 6 hours. If above is not sufficient bolus Clonidine 1 µg/kg i.v."
15763113|NCT04751812|Procedure|Low-pain opioid free|"Paracetamol, Etoricoxib, Ondansetron p.o. Betamethasone 4 mg iv.
~Anesthesia:
~Infusion Dexmedetomidin 0.2 mikrogram/kg/h iv started 5 min before induction Induction: Esketamin 0.1mg/kg + Propofol 1.5-2 mg/kg iv + rocuronium 0.5 mg/kg iv Start of surgery: Esketamin 0.1 mg/kg iv. Maintenance of anesthesia: Sevoflurane Dexmedetomidin inf 0.2 mikrogram/kg/h Esketamin inf 0.1-0.3mg/kg/h and 0.1 mg/kg adjusted after BP and HR 30 min before end of surgery Lidocaine 1 mg/kg iv
~Postoperative pain treatment:
~• Dexmedetomidin (inf 01-0.2 µg/kg/h) 4 hours postoperative
~If pain NRS ≧3 Esketamin 0.1mg/kg iv + Lidocain 0.5 mg/kg iv (max 4 mg/kg /4 h) If pain NRS ≧3 within 30 min after treatment above is given with Esketamin + Lidocain, 2.5 mg Oxycodone iv. is given and may be repeated."
15763114|NCT04751812|Procedure|Standard|"Paracetamol, Etoricoxib, Oxycodone, Ondansetron p.o. Betamethasone 4 mg iv.
~Anesthesia:
~Target controlled infusion (TCI) with doses of propofol and remifentanil based on age, weight and height. Oxycodone 0.1 mg/kg 30 minutes before cessation of remifentanil.
~Postoperative care:
~At pain NRS ≥ 4 - 5 mg of oxycodone i.v. Paracetamol will be administered every 6 hours. If above is not sufficient bolus Clonidine 1 µg/kg i.v."
15763115|NCT04751799|Device|Virtual reality headset before colposcopy|Patients wear a virtual headset presenting 360° 3D views of relaxing environments
15763116|NCT04751799|Device|Virtual reality headset during colposcopy|Patients wear a virtual headset presenting 360° 3D views of distracting environments
15763117|NCT04751786|Drug|PRECIOUS-01|Subjects will be enrolled in one of three dosing cohorts (three subjects per cohort for the planned dose escalation with a planned extension to a total of six subjects for the two highest dosing cohorts for the evaluation of the pharmacodynamic effects of PRECIOUS-01 for determination of the RP2D, if MTD is not reached).
15763118|NCT04751773|Behavioral|Exercise training|Perioperative exercise training
15763119|NCT04751760|Biological|collection of blood and urine|blood and urine will be collected during a blood test scheduled for the follow-up of the patient
15763120|NCT04751747|Procedure|Computed Tomography|Undergo CT simulation
15763121|NCT04751747|Other|Contrast Agent|Given IV
15763122|NCT04751734|Biological|Covid vaccines|women within Priority groups for coronavirus (COVID-19) vaccination
15763123|NCT04751721|Biological|CoronoVac Vaccine|CoronaVac vaccines will be inoculated in 2 doses with an interval of 24 days.
15763124|NCT04751708|Procedure|endovascular treatment|For patients randomized to endovascular treatment arm, EVT has to be initiated within 12 hours of estimated time of basilar artery occlusion. If an appropriate thrombus or residual stenosis is identified, the choice of EVT strategy will be made by the treating neurointerventionalist. The endovascular procedures allowed by the steering committee include mechanical thrombectomy, intra-arterial thrombolysis, balloon angioplasty, stent implantation, or any combination of above procedures. We recommend applying ADAPT as the first choice of treatment. All mechanical thrombectomy devices for EVT, which are approved by CFDA for this purpose, are allowed in the trial.
15763125|NCT04751708|Other|best medical management|best medical management
15763126|NCT04751695|Biological|CoronoVac Vaccine|CoronaVac vaccines will be inoculated in 2 doses with an interval of 24 days.
15763127|NCT04751682|Biological|BBV154 Vaccine|Replication deficient Adenoviral vector-based (expressing a stabilized spike protein) SARS-CoV-2 vaccine (BBV154) NLT 1X10^10 Virus Particle.
15763128|NCT04751682|Biological|Placebo|Placebo
15763129|NCT04751669|Dietary Supplement|Vitamin and trace elements|Dietary supplement oral route, once a day, during 14 days
15763130|NCT04751669|Dietary Supplement|Placebo|Dietary supplement (placebo) oral route, once a day, during 14 days
15763167|NCT04751409|Procedure|Follow-Up|Undergo limited follow-up
15763168|NCT04751409|Procedure|Imaging Technique|Undergo imaging
15763169|NCT04751409|Other|Questionnaire Administration|Ancillary studies
15763170|NCT04751396|Other|Best Practice|Receive standard educational information
15763131|NCT04751656|Behavioral|Steady Intervention|"Participants will be asked to weigh themselves daily via a smart scale that transmits weight data directly to the study team via the cellular network for 12 months. Every-other week, participants will be sent text messages providing brief feedback encouraging continued self-weighing. Moreover, if a small weight gain is observed, participants will be sent text messages aiming to engage them in commercial or community-based evidence-based weight management resources."
15763132|NCT04751643|Other|Therapeutic plasma exchange : 3 sessions in 3 consecutive days (day 1 to day 3)|"Therapeutic plasma exchange (TPE) ; 3 sessions in 3 consecutive days (Day 1 to Day 3) in intensive care unit in addition to usual treatments.
~Plasma removed is replaced by thawed fresh frozen plasma. Plasma blood volume exchanged : 1.2 Apheresis type: centrifugation"
15763133|NCT04751643|Other|Usual treatments in intensive care unit according to the current state of knowledge|Usual treatments of patients in intensive care unit with hyperinflammatory condition due to Covid-19 infection consist in supporting respiratory function, oxygen supplementation, non invasive ventilation, invasive ventilation, antibiotic, vasopressive support and corticosteroids (in absence of bacterial secondary infection)
15763134|NCT04751630|Other|Therapeutic Exercise|Online and structured exercise therapeutic program based on flexibility, strength, balance and aerobic exercises. The program have been supervised by an expert on the field and it participants will perform it under the supervision of an expert physiotherapist.
15763135|NCT04751617|Procedure|Pulmonary rehabilitation|Pulmonary rehabilitation will include: early mobilization with frequent posture changes and simple exercises in bed taking into account the patient's respiratory tract. Respiratory physiotherapy will also include improving diaphragm function along with training additional respiratory muscles. Active exercises of the upper limbs will be accompanied by gradual muscle strengthening. Aerobic regeneration will be carried out by walking along the hospital corridor, stationary bike and climbing stairs. Body balance therapy in closed systems in front of the mirror will also be included. After kinesiotherapy, the session will end with a vibration massage and relaxation of the whole body. Motivational breathing training will be used every 2 hours, 7 days a week, performed independently by the patient in the ward room. The physiotherapy process will be carried out 6 times a week and lasts 30-45 minutes a day. The duration of rehabilitation depends on the patient's condition: from 7 to 14 days.
15763136|NCT04751604|Dietary Supplement|Nicotinamide|Daily oral administration of 1,000 mg nicotinamide [1x 500-mg conventional nicotinamide tablet and 1x 500-mg tablet with controlled-ileocolonic-release nicotinamide (CICR-NAM)] for 4 weeks
15763137|NCT04751604|Dietary Supplement|Placebo|Daily oral administration of 2 matching placebo tablets for 4 weeks
15763140|NCT04751578|Device|IMPEDE-FX Embolization Plug|Fill an abdominal aortic aneurysm (AAA) sac outside of an endovascular aneurysm repair (EVAR) stent graft
15763141|NCT04751565|Other|Probing depth reduction following peri-implant therapy|Statistically significant different in terms of probing depth (PD) will be recorded between groups.
15763142|NCT04751552|Procedure|Erector Spinae Plane Block (for postoperative pain relief)|A ultrasound guided single bolus injection of 20 ml of levobupivacaine or placebo between the erector spinae muscle and process transversus of vertebra T5.
15763143|NCT04751539|Drug|AND017 single dose|AND017 administrated as oral single-dose on Day 1 in Part A
15763144|NCT04751539|Drug|AND017 multiple dose|AND017 administrated once daily from Day 1 to Day 10 in Part B
15763145|NCT04751539|Drug|Placebo|Placebo administrated once on Day 1 in Part A or daily from Day 1 to Day 10 in Part B
15763146|NCT04751526|Device|BreEStim 240|240 BreEStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.
15763147|NCT04751526|Device|EStim 240|240 EStim stimuli/visit will be applied for 10 sessions to test any accumulated analgesic effect.
15763148|NCT04751513|Other|auricular acupressure|Pressure on auricular point of Shenmen (TF4), Sympathesis (AH6a), Subcortex (AT4), Endocrine (CO18), finger (SF1), and toe (AH2) of the ear.
15763149|NCT04751500|Procedure|Outpatient hysteroscopy|Direct visualisation and careful extraction of retained pregnancy tissue using a specific hysteroscopic technology known as a hysteroscopic tissue retrieval system.
15763150|NCT04751500|Behavioral|Expectant management|Leaving the retained pregnancy tissue alone to pass by itself
15763151|NCT04751500|Drug|Medical management|Giving medications to contract the womb to pass the retained pregnancy tissue
15763152|NCT04751500|Drug|Antibiotic|Giving antibiotics to reduce any inflammation/infection caused by the retained pregnancy tissue allowing it to pass by itself
15763153|NCT04751500|Procedure|Surgical management|Passing a small cannula/catheter/currette into the womb and mechanically scraping the womb lining to remove the retained pregnancy tissue
15763154|NCT04751487|Drug|Itepekimab SAR440340|Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous
15763155|NCT04751487|Drug|Placebo|Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous
15763156|NCT04751474|Other|Motivational messages|Participants in the motivational group were sent to motivational messages to their mobile phones for 21 days.
15763157|NCT04751461|Other|Product A|P0213420, a 1.8% nicotine ENDS product
15763158|NCT04751461|Other|Product B|P0213520, a 1.8% nicotine ENDS product
15763159|NCT04751461|Other|Product C|P0211220, a 1.8% nicotine ENDS product
15763160|NCT04751461|Other|Product D|P0211820, a 1.8% nicotine ENDS product
15763161|NCT04751461|Other|Product E|P0213417, a 2.4% nicotine ENDS product
15763162|NCT04751435|Other|Cognitive interview|Researchers will use formative methods to adapt our previously-developed mainstreaming pre-genetic test educational materials plus standard post-test clinical communication materials used by the MSK CGS for use with the diverse patients. Specifically, it will adapt these materials to be responsive to patients' linguistic and literacy needs, and sensitive to their cultural diversity.
15763163|NCT04751422|Other|Electronic Health Record Review|Medical data is collected
15763164|NCT04751409|Procedure|Chest Radiography|Undergo CXR
15763165|NCT04751409|Procedure|Computed Tomography|Undergo CT-chest
15763166|NCT04751409|Procedure|Follow-Up|Undergo intense follow-up
15763173|NCT04751396|Other|Questionnaire Administration|Complete questionnaire
15763174|NCT04751396|Other|Survey Administration|Complete surveys
15763182|NCT04751357|Diagnostic Test|ECA-Test (Clot-Pro)|Thrombelastometric ECA-Test performed on Clot-Pro
15763183|NCT04751344|Drug|Liposomal bupivacaine|Prior to procedure, surgeon will administer 15cc of Lidocaine 2% plain. After the procedure is finished, 8cc of liposomal bupivacaine (13.3mg/mL) will be injected around the surgical site.
15763184|NCT04751344|Drug|Bupivacaine HCl|Prior to procedure, surgeon will administer 15cc of Lidocaine 2% plain. After the procedure is finished, 10cc of bupivacaine HCl (5mg/mL) will be injected around the surgical site.
15763185|NCT04751331|Biological|LPS|Lipopolysaccharide (LPS) (0.8ng/kg of body weight; E. coli group O:113)
15763186|NCT04751331|Biological|Saline|0.9% saline administered as an intravenous bolus
15763187|NCT04751318|Drug|Duloxetine 60mg Test Drug Enteric Coated Granules|Investigational Medicinal Product
15763188|NCT04751318|Drug|Duloxetine 60mg Reference Product Enteric Coated Granules|Cymbalta (Eli Lilly)
15763189|NCT04751305|Behavioral|Health Coaching|The weekly health coaching (HC) calls were structured to be participant-centered, built on a coach participant relationship, and include participant-determined goals, a self-discovery process to find solutions, patient accountability, and education. Before each HC call, the participants received a short questionnaire on fatigue, QOL, stress, loneliness, and social support which enabled tailoring the HC call to the individual. Educational topics are discussed in the following order: Goal Setting, Monitoring Behaviour, Barrier Management, Social Support, Stress Management, Adapting the Program, Self-Compassion, Sleep & Nutrition, Reflection, Health Media, Remote Resources, and Maintaining Motivation. However, the order of the educational topics can be adjusted based on the specific participants' needs each week. At the half-way point of the intervention, the participant provided feedback on the HC calls, ensuring optimization of HC impact.
15763190|NCT04751305|Behavioral|Online delivered Exercise Classes|The group based remote exercise program was delivered over the Zoom application (2x/wk for first 2 weeks; 1x/wk for the remaining weeks). Classes were one hour long with a ten minute warm up, 40 minute strength and conditioning focused exercise circuits, and a ten minute stretch. Each class was followed by additional time to provide participants with an opportunity to interact with each other, fostering social support.
15763191|NCT04751292|Other|Exposure to high altitude|permanence at high (>2500 m) altitude; permanence is defined as being born and living at high altitude with the total time spent at lower altitudes not exceeding 2 years in the past 10 years
15763192|NCT04751279|Other|Blood sample|Blood sample collection of 5 blood sample at the inclusion in the study the samle consite of 5 tubesEthylene Diamine Tetra Acetate (ADTA) of 7 ml
15763193|NCT04751266|Procedure|minimally invasive repair of pectus excavatum|substernal insertion of a metal bar
15763194|NCT04751266|Procedure|osteosynthesis|metal fixation of a fracture (Kirschner wire, intramedullary nail)
15763195|NCT04751253|Device|High Intensity Laser Therapy|different doses of energies of high-intensity LASER on pain and functional activity in patients with chronic knee OA.
15763196|NCT04751240|Behavioral|SIT and resistance training|Participants complete 30 sessions of sprints and resistance training. Outcomes are assessed acutely and at 6 months.
15763197|NCT04751227|Drug|Modafinil|100-200 mg oral daily for for Wakefulness in the Critical Care Units
15763198|NCT04751214|Procedure|APPENDICECTOMY|
15763199|NCT04751201|Behavioral|Mindfulness open and circular program|"At the end of the first and the last cycle, as well as 3 weeks after the last cycle, the patient will be invited to answer different questionnaires evaluating his or her quality of life (HADS, QLQC30, FA12). This is why the observation period is 3 months (3 cycles of 3 weeks + 3 weeks).
~Similarly, some of the patients included in the study will be asked to complete a semi-structured interview at the end of the MAEva programme.
~Patients and nursing staff participating in the study will be asked to complete a satisfaction questionnaire"
15763200|NCT04751188|Drug|Bezafibrate 200 MG Oral Tablet|Bezafibrate one tablet every 12 hours for six months.
15763201|NCT04751188|Drug|Placebo|Placebo one tablet every 12 hours for six months.
15763202|NCT04751188|Drug|Ursodeoxycholic Acid|At a dose of 13 to 15 mg per Kg per day.
15763203|NCT04751175|Drug|Ketamine|Ketamine, being a non-competitive antagonist of NMDA receptors, could represent a good option as an opioid treatment enhancer for acute postoperative pain and avoid chronic pain, by reducing the '' wind-up '' phenomenon of central sensitization
15763204|NCT04751175|Drug|Dexamethasone|"A meta-analysis published in September 2011 affirms that the administration of dexamethasone at a dose of 0.1 mg / kg is an effective complement to multimodal analgesia strategies to reduce postoperative pain and opioid consumption after surgery.
~Preoperative administration of the drug produces a more consistent analgesic effect than intraoperative administration"
15763205|NCT04751175|Drug|Physiologic saline|placebo
15763207|NCT04751149|Procedure|Removal of Urinary Catheter|Urinary catheter will be removed in aeseptic conditions. Before the removal a urinary culture will be obtained from the catheter.
15763208|NCT04751136|Drug|cerebrolysin|Infants of the treatment group were given Cerebrolysin in a dose of 0.1 ml / kg body weight once weekly intramuscular injection for 12 month (total of 48 injections).Each selected infant, in both treatment and control group, was assessed as regard: Socioeconomic status, Nutritional status and feeding practice, assessed for neurocognitive development
15763209|NCT04751110|Other|ultrasound guided rhomboid intercostal block|A linear ultrasound probe was medially placed in the sagittal plane on the medial border of the scapula at the T5-T7 level. We inserted a 22-gauge needle into the fascial plane between the rhomboid major and intercostal muscles in a craniocaudal direction and injected 15 ml mixture of 0.25% bupivacaine with 8 mg of dexamethasone into the fascial plane.
15763210|NCT04751097|Other|CUSH Health Digital platform|Remote mobility monitoring and physiotherapy video app
15763211|NCT04751084|Drug|Buscopan 20 milligrams/ML Injectable Solution|cases will be randomized to Buscopan group or Normal Saline group, injection will be given 5 minutes prior to embryo transfer
15763212|NCT04751071|Drug|Roflumilast 250Mcg Tab|Roflumilast 250 µg tablet once daily for 6 weeks plus the standard therapy
15763213|NCT04751071|Drug|Placebo|Placebo tablet once daily for 6 weeks plus the standard therapy
15763214|NCT04751058|Genetic|genetic analysis|"Intervention details: sampling in peripheral blood for the Methodology:
~Automatic DNA extraction (ChemagicTM 360)
~Mass sequencing using SeqCap EZ Choice Library capture technology (NimbleGen) and NextSeq sequencer (Illumina).
~Bioinformatic analysis:.
~Identification of point mutations and small deletions or insertions
~Analysis of CNVs using the BEDtools program package
~Search of the identified variants in the following public databases: 1000G, dbSNP, ExAC, EVS, GenomADm CSVS and DGV. Those with a MAF> 1% have been considered benign, in public or private databases of our population.
~The analysis process has focused exclusively on the genes described to date as associated with the pathology under study and included in the panel used. The reference sequences used for these genes are: determination of possible mutations, nucleotics, etc."
15763215|NCT04751045|Procedure|EUS liver biopsy|Endoscopic ultrasound guided liver biopsy
15763216|NCT04751019|Device|Amber Glasses|It is hoped that the use of amber glasses to complement the natural sleep-wake by inducing a perceived 'physiological darkness' to aid the secretion of melatonin should help sleep and reduce the use of hypnotic medication
15763217|NCT04751006|Other|Gaze Stabilization Exercises|Gaze group performed balance exercises with gaze stability exercise.Gaze stability exercises included two types of exercises vestibular adaptation and substitution exercises. In Adaptation exercises individual need to fixate on a visual target during horizontal and vertical head movement with a purpose of increasing gaze stability and a long term gain to vestibular system. Subsitution exercises are planned to use other eye movement stratigies to substitute vestibular function and sustained visual fixation. During Substitution exercises individual need to perfomed eye head movement between target with a purpose of clear sighting during these tasks. Balance exercises consist of both static and dynamic balance exercises with weekly progression making balance exercises more challenging.
15763218|NCT04751006|Other|Balance Training|Participants performed balance training with saccade eye exercises.balance exercises included both static and dynamic balance exercises with a purpose of increasing mobility and stability of a posture by weekly progression. These exercises included standing on firm and foam surface with eyes open or close, heel stand, toe stand, marching on firm surface, forward and backward walking with normal base of support with weekly progression. Each task was performed for 5 repetitions with weekly progression in each task.
15763219|NCT04750993|Diagnostic Test|musculoskeletal ultrasonography|The presence of subclinic synovitis findings in the hand joints was evaluated with musculoskeletal ultrasonography.
15763220|NCT04750980|Other|food allergy|food allergy
15763221|NCT04750980|Other|respiratory allergy|respiratory allergy
15763222|NCT04750980|Other|healthy controls|healthy controls
15763223|NCT04750967|Drug|Lidocaine 1% Injectable Solution|Repeated injections of lidocaine to greater occipital nerve and supraorbital nerve once a week for first four weeks then once a month for five months
15763224|NCT04750967|Drug|Amitriptyline|Amitriptyline 25 mg daily
15763225|NCT04750954|Drug|Lutetium Lu 177 Dotatate|Given IV
15763226|NCT04750954|Drug|Peposertib|Given PO
15763227|NCT04750941|Drug|Copanlisib|Copanlisib will be infused intravenously on days 1, 8, 15 of each cycle, over 1 hour, of 28-day cycles.
15763228|NCT04750941|Other|Ketogenic Diet|"In cycle 1, patients will first start the ketogenic diet for 7 days (Day -6 to Day 0).
~Only the patients who demonstrate compliance and tolerance with the ketogenic diet, as confirmed by pertinent blood and urine tests and a diary of diet, will be allowed to continue the study and start copanlisib on Day 1. The ketogenic diet will continue daily throughout the treatment days.
~In cycle 2 and beyond, patients will start the ketogenic diet and copanlisib on day 1.
~The ketogenic diet will then continue daily throughout the treatment days."
15763230|NCT04750902|Drug|0.24% Sodium Fluoride Dentifrice|Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
15763231|NCT04750902|Drug|1.5% Arginine Dentifrice|Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
15763232|NCT04750902|Drug|4.0% Arginine Dentifrice|Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
15763233|NCT04750902|Drug|8.0% Arginine Dentifrice|Whole mouth brushing with a toothpaste, 2 times/day for 2 minutes each time for the duration of the study
15763234|NCT04750889|Device|RFID tags|Installation of the RFID tag device wire localization)
15763235|NCT04750889|Device|Wire localization|Installation of the wire localization device
15763236|NCT04750876|Other|Conventional support|"Patients in the Conventional support randomisation arm will follow the usual care of amputee patients in the vascular surgery department. They will be cared for by the surgeon, nurses and nursing auxiliaries, who will provide individualised care (nursing care, mobilisation, pain management, technical care, etc.), listening and support."
15763237|NCT04750876|Other|Specific care, including the intervention of a psychologist and a physical therapist.|"In the case where the patient is in the Specific care, including the intervention of a psychologist and a physical therapist. arm, the usual care will be associated with :
~consultations with a psychologist
~The patient will also be cared for on a daily basis by a physical therapist."
15763238|NCT04750863|Other|diagnosis criteria performance|
15763239|NCT04750850|Other|Therapeutic core stability exercises|exercises focused on trunk muscle strengthening, proprioception, selective movements of the trunk and pelvis muscle, and coordination, and will be carried out in supine, sitting on a stable surface and sitting on an unstable surface (ball). The exercise involves changes in the position of the body with or without resistance, aiming to improve strength, endurance, proprioception and coordination. Training is determined by the patient's ability to undertake easy exercises and progress to more challenging exercises.
15763240|NCT04750850|Other|Usual care|Usual routine as walking and activities of daily living.
15763275|NCT04750551|Device|BreEStim|BreEStim will applied for 10 to 20 minutes.
15763241|NCT04750837|Procedure|debridement of the wound|The edges and the floor of the wound were firstly debrided, and any callosities around the wound were removed. This was repeated if needed when callosities around the wound reappeared. By this technique, the chronic wound was transformed into an acute one
15763242|NCT04750837|Biological|platelet rich plasma|Part of activated PRP was injected around the wound and under the base of the wound, while another portion of PRP was left over the floor of the wound and let to coagulate and form a gel.
15763243|NCT04750837|Procedure|conventional dressing|The wound was irrigated by normal saline, covered by vaseline gauze then sterile dressing. Repeated dressing every two days till 20 weeks, if the wound failed to heal at that time
15763244|NCT04750824|Drug|Afatinib|Afatinib
15763245|NCT04750824|Drug|other systemic therapy|other systemic therapy
15763246|NCT04750798|Device|BWI Medical Device|Participants will be treated with commercially approved BWI medical devices following routine clinical practice. No specific intervention will be observed for this study.
15763247|NCT04750785|Other|No Intervention|Administered as specified in the treatment arm.
15763248|NCT04750772|Diagnostic Test|18F-FDG and 68Ga-NOTA-FAPI04 PET/CT|Each subject receive a single intravenous injection of 18F-FDG and 68Ga-NOTA-FAPI04, and undergo PET/CT imaging within the specified time
15763249|NCT04750772|Diagnostic Test|18F-FDG and 18F-NOTA-FAPI04 PET/CT|Each subject receive a single intravenous injection of 18F-FDG and 18F-NOTA-FAPI04, and undergo PET/CT imaging within the specified time
15763250|NCT04750759|Drug|Niclosamide + Camostat|Niclosamide will be applied in combination with camostat.
15763251|NCT04750759|Other|Placebo|Placebo to interventional drug
15763252|NCT04750746|Other|Control group|Conventional Therapy Passive ROM and/or AROM exercises Muscle strengthening; Therapeutics stretching of the shoulder, the elbow, the wrist, and the fingers. Activities of daily living training, including eating, grooming, dressing, toileting, and transfer
15763253|NCT04750746|Other|Experimental Group|Interventional therapy Xbox Kinect (Xbox 360, Microsoft,) For training, programs such as Boxing and Bowling in the Kinect sports pack and Rally Ball, 20,000 Leaks, and Space Pop in the Kinect adventure pack, all of which required the use of the upper extremities, will be selected
15763254|NCT04750733|Other|Assessment|Assessment of core strength and endurance, muscle strength, postural sway in different condition, physical capacity and fatigue
15763255|NCT04750720|Other|Sampling by venipuncture (and eventually by nasopharyngeal swab)|"Biological samples :
~Serum and plasma from each donor for the purpose of performing (if applicable) the SARS-CoV-2 serologic test
~PBMC (peripheral blood mononuclear cells)
~Nasopharyngeal samples (not mandatory)
~Associated data :
~Demographic data
~Description of clinical manifestations related to SARS-CoV-2 infection
~Notion of hospitalization/ambulatory follow-up
~Blood Fractioning
~Serum and plasma aliquoted and stored under 250, 500 and 1000 µL (at -80°C)
~Separation of PBMC on Lymphoprep and freezing in liquid nitrogen for subsequent analysis of immune system cells"
15763256|NCT04750707|Drug|Hydroxyurea|The study intervention will be daily oral Hydroxyurea given in single doses starting at approximately 20mg/kg/day and escalated to a maximum 30mg/kg/day depending on clinical need and according to standard guidelines.
15763257|NCT04750694|Behavioral|Resistance training|A full-training programme with high intensity followed by back squat exercise with blood flow restriction. Inflatable cuffs will be placed proximally on both thighs. The cuff pressure will be 50% of individual arterial occlusion pressure and will be maintained during the rest intervals. Participants will perform 30, 15, 15 and 15 repetitions of 30% of 1 Repetition Maximum. Totally 75 repetitions will be performed. 45 seconds rest interval between sets will be given.
15763258|NCT04750681|Dietary Supplement|Placebo|Subjects orally ingested, with water, one capsule per day (in the evening)
15763259|NCT04750681|Dietary Supplement|Saffron|Subjects orally ingested, with water, one capsule per day (in the evening)
15763260|NCT04750668|Other|Multisensory Balance Training|Multisensory Balance training includes 30 minutes per day, 5 days a week for 4 weeks, using visual, proprioceptive, and vestibular manipulations. The exercises involved movements of the eye, head, and body to stimulate the vestibular system, postural control exercises in different positions (feet together, tandem stance, and one leg stance), use of a soft surface to reduce the proprioceptive inputs, and exercises with closed eyes to deprive them of visual cues.
15763261|NCT04750655|Drug|Moxifloxacin (Topical)|We are using moxifloxacin as indicated and as intended for use as an antibiotic during surgery. Frequency of postoperative antibiotics dependent on group randomization.
15763262|NCT04750642|Device|CI632D|CI632 cochlear implant with Slim Modiolar electrode including dexamethasone in the electrode within wells (CI632D)
15763263|NCT04750642|Device|CI632|CI632 cochlear implant with Slim Modiolar electrode with market approval and does not include dexamethasone
15763264|NCT04750629|Device|POC CoviDx™ Rapid Antigen Test|All patients will have a nasal swab for CoviDx™ Rapid Antigen testing
15763265|NCT04750616|Drug|Niacinamide|Niacinamide 3 grams on the day of surgery and post-surgical days one and two
15763266|NCT04750616|Drug|Placebo|Matched placebo on the day of surgery and post-surgical days one and two
15763267|NCT04750603|Drug|Fluticasone furoate (FF)/Vilanterol (VI)|Patients with a positive exercise challenge test were allocated to a single administration of salbutamol (400 µg) and 22 to FF/VI (92/22 µg) in a double blind, double dummy method to assess the short-term effect on exercise induced complaints
15763268|NCT04750603|Drug|Salbutamol|Patients with a positive exercise challenge test were allocated to a single administration of salbutamol (400 µg) and 22 to FF/VI (92/22 µg) in a double blind, double dummy method to assess the short-term effect on exercise induced complaints.
15763269|NCT04750590|Procedure|en bloc resection, morcellation|Laser en bloc resection with subsequent tumor morcellation will be performed. This tissue will be sent for histology in order to estimate the histological subtype and differentiation grade. Next stage laser resection of the tumor basis will be performed with subsequent histology to determine the depth of invasion and the status of surgical margin.
15763270|NCT04750590|Procedure|piecemeal resection, tissue removal by loop|Tumor piecemeal resection will be performed with electric loop. Then fragments of the tumor will be removed by the loop or Janet's syringe. Fragments from the base of the tumor will be sent separately in order to assess which stage the tumor is at and its surgical margin status.
15763273|NCT04750564|Device|BreEStim|BreEStim will applied for 10 to 20 minutes.
15763277|NCT04750538|Device|BreEStim 120|120 BreEStim stimuli will applied for about 10 minutes.
15763278|NCT04750538|Device|BreEStim 240|240 BreEStim stimuli will applied for about 20 minutes.
15763279|NCT04750525|Device|BreEStim|120 BreEStim stimuli will applied for about 10 minutes.
15763280|NCT04750525|Device|EStim|120 EStim stimuli will applied for about 10 minutes.
15763281|NCT04750512|Procedure|ESP block|US guided ESP infiltration (saline solution vs Ropivacaine 0.2% according to randomization): bilateral injection of 30ml (60ml total) under US guidance between the deep fascia of erector spinae muscle and the the two transverse process at the level of the 10th thoracic vertebrae
15763282|NCT04750512|Procedure|TAP block|"US guided TAP block (saline solution vs Ropivacaine 0.2% according to randomization):
~bilateral injection of 30ml (total 60ml) under US guidance in the plane between the internal oblique and transversus abdominis muscles at the level of the midaxillary line in the Petit triangle."
15763283|NCT04750499|Procedure|Adipose tissue injection associated with endorectal advancement flap.|"Injection of adipose tissue will be associated with endorectal advancement flap technique. In blind fistulas and special cases, in which the flap is not indicated, alternative techniques will be used. In all cases, autologous, micro-fragmented and minimally manipulated adipose tissue, obtained with a standardized procedure, previously validated and authorized, will be injected. This procedure uses the Lipogems ® device (Lipogems International SpA, Milan, Italy), with which a well-characterized adipose tissue is obtained with the maximum safety guarantees."
15763284|NCT04750486|Device|Sequential compression devices|Two lower limb intermittent compression devices to be placed on the mid-calf of each leg.
15763285|NCT04750473|Procedure|Computed Tomography|Undergo PET/CT scan
15763286|NCT04750473|Drug|Fluciclovine F18|Given IV
15763287|NCT04750473|Drug|Gallium Ga 68 Gozetotide|Given IV
15763288|NCT04750473|Procedure|Positron Emission Tomography|Undergo PET/CT scan
15763289|NCT04750460|Drug|Teriparatide|Subcutaneous injections of study drug will be assigned immediately after parathyroidectomy (20 mcg), on the 1st (20 mcg) and 2nd (10 mcg) postoperative day.
15763290|NCT04750447|Device|XEN 63|The Xen gelatin microstent (Allergan, CA, USA) is a 6mm gelatin tube used in microinvasive glaucoma surgery (MIGS) to create a bleb. A bleb is a fluid filled blister located in the tissue covering the white portion of the eye (the conjunctiva) created after glaucoma surgery. The bleb allows the eye pressure (intraocular pressure - IOP) to be lowered by bypassing the natural pathways by which the fluid called aqueous leaves the eye and redirecting it towards the bleb to be absorbed by other pathways. Amongst the main advantages of this device is the ability to create a bleb without disrupting tissue unlike other methods of glaucoma surgery (e.g., trabeculectomy). This decreases the amount of wound healing and scarring, and potentially limiting bleb failure.
15763291|NCT04750421|Device|Transillumination Venolux®|Transillumination Venolux® method was used on the other half of the face before injections to visualize veins.
15763292|NCT04750408|Device|Standard oxygen|COT describes the application of low-flow oxygen in any way (Hudson mask, nasal prongs,...).
15763293|NCT04750408|Device|Nasal high-flow|F is combination of room air supplemented with oxygen can be better patients. This gas mixture will be provided to the patient with a specialized nasal prong.
15763294|NCT04750395|Drug|Haloperidol Solution|Oral transmucosal haloperidol solution 2.5mg
15763295|NCT04750395|Drug|Olanzapine Tablets|Oral transmucosal olanzapine tablet 5.0mg
15763296|NCT04750382|Drug|HX008+Cisplatin+Gemcitabine|Participants will receive HX008 3mg/kg, Day 1,Q3W for up to 2 years + Cisplatin 75mg/m^2, Day 1, Q3W for up to 6 cycles +Gemcitabine 1250mg/m^2, Day 1, Day 8, Q3W for up to 6 cycles
15763297|NCT04750343|Biological|GBP510 adjuvanted with AS03 (RBD 10μg/dose) - Stage 1|Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with AS03 (RBD 10μg/dose) on Days 0 and 28.
15763298|NCT04750343|Biological|GBP510 (RBD 10μg/dose) - Stage 1|Participants will receive intramuscular (IM) injections of GBP510 (RBD 10μg/dose) on Days 0 and 28.
15763299|NCT04750343|Other|Normal saline (0.9% sodium chloride solution) - Stage 1|Participants will receive intramuscular (IM) injections of Normal saline on Days 0 and 28.
15763300|NCT04750343|Biological|GBP510 adjuvanted with AS03 (RBD 25μg/dose) - Stage 1|Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with AS03 (RBD 25μg/dose) on Days 0 and 28.
15763301|NCT04750343|Biological|GBP510 (RBD 25μg/dose) - Stage 1|Participants will receive intramuscular (IM) injections of GBP510 (RBD 25μg/dose) on Days 0 and 28.
15763302|NCT04750343|Other|Normal saline (0.9% sodium chloride solution) - Stage 1|Participants will receive intramuscular (IM) injections of Normal saline on Days 0 and 28.
15763303|NCT04750343|Biological|GBP510 adjuvanted with AS03 (RBD 10μg/dose) - Stage 2|Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with AS03 (RBD 10μg/dose) on Days 0 and 28.
15763304|NCT04750343|Biological|GBP510 adjuvanted with AS03 (RBD 25μg/dose)- Stage 2|Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with AS03 (RBD 25μg/dose) on Days 0 and 28.
15763305|NCT04750343|Biological|GBP510 (RBD 25μg/dose)- Stage 2|Participants will receive intramuscular (IM) injections of GBP510 (RBD 25μg/dose) on Days 0 and 28.
15763306|NCT04750343|Other|Normal saline (0.9% sodium chloride solution)- Stage 2|Participants will receive intramuscular (IM) injections of Normal saline on Days 0 and 28.
15763307|NCT04750317|Drug|Tofacitinib|Tofacitinib was administered at a dose 10 mg twice daily on day 1, followed by 5 mg twice daily on day 2-5. The dosage was reduced up to 5 mg once daily in patients with moderate renal impairment or moderate hepatic impairment.
15763308|NCT04750304|Behavioral|Application ARTHe|Patient will use ARTHe Application for 3 months
15763311|NCT04750278|Drug|FP-025 100 mg|FP-025 100 mg BID
15763312|NCT04750278|Drug|FP-025 300 mg|FP-025 300 mg BID
15763313|NCT04750278|Drug|Placebo|Placebo BID
15763314|NCT04750265|Device|Robotic assisted early mobilization|Robotic assisted early mobilization Robotic assisted early mobilization started within 72 hours of ICU admission.
15763315|NCT04750252|Biological|StroMel|Autologous MSC
15763316|NCT04750239|Drug|Nivatrotamab|Anti GD2×CD3 monoclonal bi-specific antibody
15763318|NCT04750200|Procedure|Embolization of the Middle Meningeal Artery|EMMA is performed inside of the blood vessels where tiny catheters are used to deliver polymer embolic agents to block small blood vessels supplying the brain coverings. A particulate polymer embolic agent (also called polyvinyl acrylate, PVA) or a liquid embolic agents (polymers of ethynyl vinyl alcohol, EVOH) can be used.
15763319|NCT04750187|Other|Hypo-pressive abdominal exercise intervention|An 8-week hypo-pressive abdominal exercise program
15763320|NCT04750174|Other|Kinesiotaping|Kinesiotape (KT) has been used by Dr. Kenzo Kase for the first time as based on the opinion that more successful results can be obtained in a banding method similar to the structural characteristics and flexibility of human skin without limiting the joint movements for edema control, joint protection, and proprioception training. In recent years, KT have been applied with a wide variety of techniques including muscle techniques for the inhibition and stimulation of muscles, fascia correction technique which aims to reduce tension and adhesions by making vibration movement between the fascia layers and field correction technique aiming to reduce regional pressure in the presence of pain, inflammation or edema as well as lymphatic correction technique for regulating lymphatic circulation .
15763321|NCT04750161|Other|No intervention|No intervention will be given to participants. It is purely observational.
15763322|NCT04750148|Diagnostic Test|6-minute walk test|The subject walks as far as possible for 6 minutes along a 30m long corridor.
15763323|NCT04750148|Diagnostic Test|2-minutes walk test|The subject walks as far as possible for 2 minutes along a 30m long corridor.
15763324|NCT04750148|Diagnostic Test|10-meters walk test|The natural and fast walking speeds of the subject are measured over 10m. This speed is measured by the examiner as well as by the subject (self-tested version).
15763325|NCT04750148|Diagnostic Test|One leg stance test|The time held in unipodal equilibrium is measured by the examiner.
15763326|NCT04750135|Drug|metformin 500 mg TID Oral Tablet|biguanides derivatives
15763327|NCT04750135|Drug|Placebo|Placebo
15763328|NCT04750122|Drug|neoadjuvant chemotherapy upon in vitro PTC drug sensitivity screenning|The choice of chemotherapy is based on the PTC drug sensitivity results.
15763329|NCT04750083|Drug|HX008|HX008 200 mg intravenously (IV) on Day 1 of every 3-week cycle (Q3W) for up to 35 cycles
15763330|NCT04750083|Drug|Pembrolizumab|Pembrolizumab 200 mg intravenously (IV) on Day 1 of Q3W for up to 35 cycles
15763331|NCT04750083|Drug|pemetrexed|pemetrexed 500 mg/m^2 IV on Day 1 of Q3W for up to 35 cycles
15763332|NCT04750083|Drug|cisplatin/carboplatin|cisplatin 75 mg/m^2 IV OR carboplatin AUC 5 IV on Day 1 of Q3W for 4 cycles
15763333|NCT04750070|Drug|Dopamine|Children will receive dopamine, 8 microgram/kg.min (increasing the dose after 15 minutes to 12 microgram/kg/min to a maximum of 15 microgram/kg/min)
15763334|NCT04750070|Drug|adrenaline|Children will receive adrenaline, 0.1 microgram/kg/min (increasing the dose after 15 minutes to 0.2 microgram/kg.min to a maximum of 0.3 microgram/kg.min)
15763335|NCT04750070|Drug|Blood Transfusion|Children will receive a transfusion of whole human blood in a dose of 10 mL/kg over 2-3 hours. While the blood transfusion is being arranged, IV fluid would be given @ of 3 ml per kg per hour
15763336|NCT04750057|Drug|Anifrolumab|Multi-centre, open-label, early access program (EAP) designed to provide access to intravenous (IV) treatment regimen of 300 mg anifrolumab (MEDI-546) every 4 weeks (Q4W) for eligible patients with moderate-to-severe active SLE while receiving standard therapy.
15763337|NCT04750044|Other|early refeeding|In the early refeeding group, oral diet is started 24 hours after PEP is confirmed. The oral diet starts with SOW (Sips of water) and builds up sequentially in the order of clear liquid diet-soft diet, considering patient tolerability.
15763338|NCT04750044|Other|delayed refeeding|In the delayed refeeding group, oral diet is started after confirmation of restoring of normal bowel sound, pain decreasing below VAS 2. The oral diet starts with SOW (Sips of water) and builds up sequentially in the order of clear liquid diet-soft diet, considering patient tolerability.
15763339|NCT04750031|Procedure|Liver Biopsy|Liver biopsy is a procedure to obtain small amount of liver by a needle.
15763340|NCT04750018|Other|surgery|Patients were divided into surgery and no disease.
15763341|NCT04750005|Other|Listerine Cool Mint|Participants use 20 mL of Listerine cool mint mouth rinse for 30 sec after brushing twice a day.
15763342|NCT04750005|Other|Colgate Cavity Protection Toothpaste|Participants used Colgate cavity protection toothpaste for brushing teeth twice daily.
15763343|NCT04750005|Other|Reach Unflavored Waxed Dental Floss|Participants after brushing for 1 minute, rinse mouth with water and FLOSS once a day in first use.
15763344|NCT04750005|Other|American Dental Association (ADA) Ref Toothbrush|Participants will brush twice daily for 1 minute with the toothpaste and soft bristled toothbrush provided.
15763345|NCT04749992|Procedure|Polysomnographic examination in sleep laboratory (PSG measurement)|Recording of sleep quality and quantity by sleep parameters, such as total sleep time - TST; duration of sleep stages - S1t, S2t, S3t, rapid eye movement - REMt; sleep onset latency - SL; wake after sleep onset - WASO, sleep efficiency - SE.
15763346|NCT04749979|Drug|Agonist (decapeptyl )|giving agonist
15763347|NCT04749979|Drug|HCG ( eg. Choriomon )|giving HCG
15763349|NCT04749953|Procedure|Maxillary sinus floor augmentation|The sinus membrane of the maxillary sinus is elevated to create a space for the grafting material and placement of dental implants in the posterior maxilla
15763350|NCT04749940|Other|Half of the harvested area will be dressed with PRF dressing, and half with Aquacel®.|Half of the harvested area will be dressed with PRF dressing, and half with Aquacel®.
15763351|NCT04749914|Drug|Lasmiditan|Administered orally.
15763352|NCT04749914|Drug|Dabigatran Etexilate|Administered orally.
15763353|NCT04749914|Drug|Rosuvastatin|Administered orally.
15763354|NCT04749901|Other|Psycho-emotional and semiological measures|Surveys, interviews and measures
15763402|NCT04749498|Other|Oat Bread|In a crossover design, this bread was served with a standard breakfast to compare other breads.
15763403|NCT04749485|Drug|HX008|Patients will receive HX008 3mg/kg by intravenous (IV) infusion on Day 1, every 3 weeks (Q3W), till progressed disease or withdrawal.
15763404|NCT04749472|Other|Sling|Participants wore six different shoulder slings in a randomized order.
15763355|NCT04749888|Behavioral|Targeted nurse-led home visiting|The KECHI encompasses 25-29 home visits, group activities, and community service linkage by social workers from the prenatal period until the child reaches the age of 2 years; as such, it is a complex intervention involving various domains to address a wide range of outcomes. Pregnant women with two or more risk factors who are deemed to have difficulties in raising children are eligible for the targeted multiple nurse home visits. Each home visit is implemented based on families' needs, and individualized interventions are provided to improve parenting and the home environment in order to promote the child's health and development and maternal health. The program includes educational materials for parents, such as a booklet covering issues on prenatal care, child development, postnatal child care, parent-child attachment, play, communication, safety, and goal-setting.
15763356|NCT04749875|Other|blood sample|sampling of blood for research during routine care
15763357|NCT04749862|Other|Online symptom reporting|Online symptom reporting questionnaire with linked self-management advice
15763358|NCT04749836|Procedure|His bundle pacing implantation, Left bundle branch area pacing implantation, Bachmann bundle pacing|"Different active fixation leads and the dedicated delivery sheaths are introduced via standard transvenous approach under fluoroscopic guidance. His bundle potential mapping is performed in a unipolar setting with the use of the electrophysiological system for His bundle pacing. After localizing the His bundle potential, the pacing is attempted before the lead fixation to confirm HB capture. The lead is then screwed into position. Acute HBP threshold ≤ 2.5V at 1ms is considered acceptable. On the other hand, the initial site for LBBP is approximately 1-1.5 cm distal to the HBP lead position in the RV septum along the line between the HBP site and RV apex in the right anterior oblique (30°) fluoroscopic view. Bachmann bundle pacing (upper atrial septum) will be performed with the J-stylet modification technique or with specialized catheter method using the SelectSecure active fixation lead.
~Stepwise approach for conduction pacing will also be tested."
15763359|NCT04749823|Other|Blended treatment program|A combined treatment program with specific active neck exercises and general aerobic training in counteractive amount will be executed during 12 weeks. Nine supervised sessions will be supplemented with 1 to 3 weekly unsupervised home exercise sessions.
15763360|NCT04749823|Other|Specific strength exercise program|This program includes an individual, patient-tailored exercise program with the aim of retraining the neck musculature. A detailed exercise programme will be constructed in which all exercises are listed with the amount of repetitions and series of each exercise. Strength exercises will be performed by means of dumbbells with different weights and elastic bands with different degrees of resistance. The amount of weight or resistance, and the amount of series and repetitions will be evaluated during the first session. This exercise programme will be re-evaluated repeatedly during the course of the program. Specific strength neck exercises will be performed for 30 minutes. Nine supervised sessions will be supplemented with 1 to 3 weekly unsupervised home exercise sessions.
15763361|NCT04749823|Other|General aerobic exercise program|This control group will receive a general aerobic exercise program. Within a 12-week period, patients will be instructed to perform a general aerobic exercise session 3 times a week.
15763362|NCT04749810|Drug|Elizaria®|Induction cycle: 900 mg (3 vials of 30 mL, 10 mg/mL) intravenous infusion for 30 minutes once a week for 4 weeks. Maintenance therapy: 1200 mg (4 vials of 30 mL, 10 mg/mL) intravenous infusion for 30 minutes in Week 5, followed by 1200 mg every 14 days.
15763363|NCT04749797|Drug|Liposomal bupivacaine|Used as cranial block for craniotomy surgery
15763364|NCT04749797|Drug|Bupivacaine Injection|Used as cranial block for craniotomy surgery
15763365|NCT04749797|Drug|Saline|Used as cranial block for craniotomy surgery
15763366|NCT04749784|Dietary Supplement|High Dose Arterin Cholesterol|240mg active ingredient daily
15763367|NCT04749784|Dietary Supplement|Low Dose Arterin Cholesterol|120mg active ingredient daily
15763368|NCT04749784|Dietary Supplement|Placebo|Placebo tablet
15763369|NCT04749771|Behavioral|Filming Interactions to Nurture Development|FIND is a brief video coaching intervention which involves feedback provided by the coach to the caregiver using brief film clips derived from video of caregiver-child interaction collected in the home.
15763370|NCT04749771|Behavioral|The Healthy Toddler Program|HTP, the active control intervention, consists of weekly sessions alternating between (a) coaching sessions covering one of five domains of child development (Motor, Cognitive, Language, Play, and Social-Emotional and (b) observation sessions that will include a review of the prior coaching session and an observation and discussion of the caregiver-child interaction.
15763371|NCT04749758|Biological|SVF treatment|SVF treatment is developed by Cellab Laboratory (Celstem®). It is made following strict manufacturing guidelines and approved by Andorra's Government authorities. An abdominal fat liposuction is required to obtained Celstem®. The preparation of the product is carried out exclusively in a clean laboratory room under the conditions described by the AABB (American Association of Blood Banks) standards. The treatments application is carried out on the same day of the extraction, at some point between the next 6 hours from the end of the extraction. Firstly, ultrasound joint evaluation is performed. Under sterility measures, intraarticular infiltration of SVF treatment is performed at affected knee or knees. Previous synovial fluid aspiration is performed, if required. Once the procedure is completed, rehabilitation recommendations and clinical follow-up information is provided.
15763372|NCT04749745|Drug|L-theanine|The subject will receive paired-pulse TMS (ppTMS) procedure before and 30min after taking the drug orally, to assess motor cortex excitability, measured by surface electromyogram (EMG). The ppTMS procedure is administered by a TMS stimulator controlled a program software named Signal. The coil of the stimulator is placed above the scalp where the stimulation would activate the left primary motor cortex region that controls the right thumb. When a pulse stimulation is delivered by the coil, the EMG over a thumb muscle (abductor pollicis brevis) will record a motor-evoked potential on the tracing. Cross-over with placebo in two separate sessions at least 72 hours apart.
15763373|NCT04749745|Drug|Placebo|The subject will receive paired-pulse TMS (ppTMS) procedure before and 30min after taking the drug orally, to assess motor cortex excitability, measured by surface electromyogram (EMG). The ppTMS procedure is administered by a TMS stimulator controlled a program software named Signal. The coil of the stimulator is placed above the scalp where the stimulation would activate the left primary motor cortex region that controls the right thumb. When a pulse stimulation is delivered by the coil, the EMG over a thumb muscle (abductor pollicis brevis) will record a motor-evoked potential on the tracing. Cross-over with L-theanine in two separate sessions at least 72 hours apart.
15763374|NCT04749732|Behavioral|WalkingPad plus Psychological Intervention - PsyWPad Group|The 24-week walking program will be monitored by the WalkingPAD application that will accompany the patient on their walks and record their adherence to the previously defined individual program. Motivational support for a behavioral intervention will include two face-to-face sessions and the following contacts will be made over the phone. The behavioral motivational intervention will follow the principles of 1) motivational interview, will be based on 2) Theory of self-determination, taking into account 3) components of the Transtheoretical Model of Change and the Theory of Planned Behavior.
15763375|NCT04749732|Behavioral|WalkingPad plus Virtual Assistant - CyberWPad Group|The 24-week walking program will be monitored by the WalkingPAD application, which will accompany the patient on their walks and record their adherence to the previously defined individual program. Motivational support will be provided by a virtual assistant through daily and on-the-spot interactions and through support and motivational messages.
15763376|NCT04749732|Behavioral|WalkingPad group - Paper WPad Group|The 24-week walking program will be supported by a printed prescription of an individualized HbET previously defined on the WalkingPAD platform. However, this group of patients will not have the support of an application to monitor and record adherence to the program. Motivational support for a behavioral intervention will include two face-to-face sessions and the following contacts will be made over the phone. The behavioral motivational intervention will follow the principles of 1) motivational interview, will be based on 2) Theory of self-determination, taking into account 3) components of the Trans-Theoretical Model of Change and the Theory of Planned Behavior.
15763377|NCT04749719|Device|remotely supervised transcranial direct current stimulation|Low levels of electrical current are applied across the scalp to induce small changes in brain activity. This is done using remote supervision.
15763378|NCT04749706|Behavioral|Physical training alone|The physical activity intervention will consist in 12 weeks of training composed of 3 sessions per week. The three sessions will be mainly composed of resistance training aiming at increasing body weight through increased fat free mass. The main muscle groups (lower limbs, upper limbs and trunk) will be trained. The intervention will be performed under the supervision of a specialized coach.
15763379|NCT04749706|Behavioral|physical training + protein intake|"The physical activity intervention will consist in 12 weeks of training composed of 3 sessions per week. The three sessions will be mainly composed of resistance training aiming at increasing body weight through increased fat free mass. The main muscle groups (lower limbs, upper limbs and trunk) will be trained. The intervention will be performed under the supervision of a specialized coach.
~15 women with constitutional leanness will, on top of the physical training, received a daily protein supplementation corresponding to 20 grams of proteins + 10 grams of Maltodextrine"
15763380|NCT04749693|Device|DBLG1 System|Use of DBLG1 System in real life condition
15763381|NCT04749680|Device|PD cycler Silencia|Treatment for 2 weeks either with PD-Night or Homechoice PD cycler (Comparators) depending on the previous Treatment ((clinical phase I). At the end of these 2 treatment weeks and a subsequent training phase which up to 3 weeks, treatment with the Silencia PD cycler for 2 further weeks (clinical phase II).
15763382|NCT04749667|Other|MSCs|Autologous bone-marrow derived mesenchymal stem cells
15763383|NCT04749667|Drug|Saline|Isotonic saline
15763384|NCT04749654|Other|The Salivary pH measured|The saliva samples were obtained at 10-12 a.m. from all children. The saliva was collected into plastic cylinders and the salivary pH was measured with a pH meter (Compact pH meter B-212 twin pH, HORIBA, Osaka, Japan).
15763385|NCT04749654|Other|The saliva flow rate was measured|The saliva flow rate was estimated by during the first 30 s of paraffin chewing. The saliva was collected into plastic cylinders for a period of 5 minutes. Afterward, the saliva were weighed with a in a precision balance (Mettler PC 400, Zurich, Switzerland) and the flow rate was computed in gms/ml.
15763386|NCT04749654|Other|Streptococcus mutans and Lactobacillus counts in saliva were measured|The saliva samples were obtained according to described above. Numbers of colony-forming units (CFU) of S. mutans were counted on TSY20B agar and Lactobacilli were counted on Rogosa agar.
15763387|NCT04749641|Biological|Histone H3.3-K27M Neoantigen Vaccine Therapy|"The researched vaccine, containing H3.3-K27M-targeting neoantigen peptides and poly ICLC, will be administered through subcutaneous injection into DIPG patients after they complete surgical/stereotactic biopsy and conformal radiotherapy. The day of first vaccine injection is defined as D1 (day 1), and then the injections will be administered on D3, D15, Day 29, Day 57, Day 85 and one injection every 8 weeks thereafter. In order to determine the Maximum Tolerated Dose (MTD) of the vaccine, a 6+3 dose escalation design is applied. There are three doses for the vaccine. Dose 1: 0.5mg peptide + Poly ICLC; Dose 2: 1mg peptide + Poly ICLC; Dose 3: 2mg peptide + Poly ICLC."
15763388|NCT04749628|Drug|cannabidiol|Epidiolex (cannabidiol) oral solution
15763389|NCT04749628|Other|Sesame Oil|Sesame oil placebo
15763390|NCT04749615|Drug|Periarticular Injection (PAI)|PAI is a widely-utilized, surgeon-performed, analgesic intervention for TKA patients.
15763391|NCT04749615|Drug|Saline Control Periarticular Injection (PAI)|equal volume of saline will be used in place of analgesics used in PAI injections
15763392|NCT04749602|Drug|Nivolumab|40 mg of the nivolumab will be used intrapleurally (once).
15763393|NCT04749589|Diagnostic Test|iron deficiency|Its not an intervention. Its an observational study. The groups are defined based on their iron status
15763394|NCT04749576|Dietary Supplement|saffron supplement for IBD|anti inflammatory effect
15763395|NCT04749563|Drug|IGC AD1|IGC AD1 oral Solution
15763396|NCT04749563|Drug|Placebo|Placebo of IGC AD1 oral Solution
15763397|NCT04749524|Diagnostic Test|Measurement of Otoacoustic Emissions with and without suppression noise|Otoacoustic emissions will be recorded using an ear probe with and without a suppression noise.
15763398|NCT04749511|Behavioral|Extrambulatory digital PROMs detection|The aim of the study is to investigate the validity of an alternative method of evaluating PROMs in which the questionnaire will be administered to the patient digitally (Google Forms) in an out-of-patient setting.
15763399|NCT04749498|Other|White Bread|Test breakfast with white bread was served after 12-hours of fasting and participants were asked to consume the meal in full, within 15 minutes.
15763400|NCT04749498|Other|Whole Wheat Bread|In a crossover design, this bread was served with a standard breakfast to compare other breads.
15763401|NCT04749498|Other|Barley Bread|In a crossover design, this bread was served with a standard breakfast to compare other breads.
15763405|NCT04749459|Drug|ChapStick Moisturizer, Strawberry Flavor|A single topical application of ChapStick Moisturizer, Strawberry Flavor will be applied to the appropriate 40 square centimeter (cm^2) test site (on the back of each participants). This application shall provide a test material film of approximately 2.00 +/- 0.05 milligram per centimeter square (mg/cm^2), using 80 +/-2 milligrams (mg) of material.
15763406|NCT04749459|Drug|ChapStick Moisturizer, Classic Flavor|A single topical application of ChapStick Moisturizer, Classic Flavor will be applied to the appropriate 40 cm^2 test site (on the back of each participants). This application shall provide a test material film of approximately 2.00 +/- 0.05 mg/cm^2, using 80 +/-2 mg of material.
15763407|NCT04749459|Drug|ISO 24444:2010 P2 Standard Reference Sunscreen|A single topical application of ISO 24444:2010 P2 Standard Sunscreen will be applied to the appropriate 40 cm^2 test site (on the back of each participants). This application shall provide a test material film of approximately 2.00 +/- 0.05 mg/cm^2, using 80 +/-2 mg of material.
15763408|NCT04749446|Other|Treatment of Breast Sarcoma according clinical practice (includes drugs, surgery or any other received treatments)|"This observational study collects all the treatments received by the patients according clinical practices or experimental trials and therefore includes drug/biological/surgical and any other applicable treatments
~Reorder Outcome Measures"
15763409|NCT04749433|Drug|[11C]CPPC Injection|A single dose of [11C]CPPC (370 megabecquerel (MBq) (X±1 mCi)) intravenously and subsequent positron emission tomography (PET) scan.
15763410|NCT04749420|Other|Survey study|Cervical Radiculopathy Impact Scale (CRIS) will be applied
15763411|NCT04749407|Genetic|biomarker detection|PBMC and ctDNA analysis
15763412|NCT04749394|Drug|Camrelizumab, PD-1 monoclonal antibody|Camrelizumab 200mg IV, Q3W, until clinical progression/deterioration or confirmed radiological progression, or up to 1 year.
15763413|NCT04749394|Drug|Apatinib, VEGFR2 antibody|Apatinib 250mg PO, QD, until clinical progression/deterioration or confirmed radiological progression, or up to 1 year.
15763414|NCT04749381|Combination Product|acupoint with TCM|The acupoint application was made of traditional Chinese medicine (TCM), and the therapeutic effect was produced through the stimulation of TCM drugs and acupoints.
15763415|NCT04749381|Combination Product|acupoint with placebo|The placebo acupoint application was made of black beans and honey, which shares the similar shape and smell of the experiment group, applied at the same acupoints.
15763416|NCT04749368|Drug|BRII-835 (VIR-2218)|BRII-835 (VIR-2218) will be given by subcutaneous injection
15763417|NCT04749368|Biological|BRII-179 (VBI-2601) with IFN-α|BRII-179 (VBI-2601) with IFN-α will be co-administered by intramuscular injection
15763418|NCT04749368|Biological|BRII-179 (VBI-2601)|BRII-179 (VBI-2601) will be administered by intramuscular injection
15763419|NCT04749355|Drug|BST-236|BST-236 is a conjugate of cytarabine and asparagine, provided as a sterile lyophilized powder for IV administration
15763420|NCT04749342|Other|Physiotherapy Treatment|Physical Therapy sessions for treatment of advanced Lymphedema Cases
15763421|NCT04749329|Device|Mesh Group|"All MG patients underwent the procedure with ante rectus positioned prophylactic mesh according to the following standardized technique. A BIO-A circular-shaped mesh measuring 8X10 cm in diameter is prepared with an internal 2 cm hole to let the bowel pass.
~An at least 8x8 cm space is created between the anterior rectus sheath and the rectus abdominis muscle and, then, the mesh is positioned. The bowel is passed through the rectus muscle via the circular incision in the middle of the mesh. Single absorbable monofilament sutures anchored the mesh laterally in the ante rectus pocket, while medially the mesh is fixed with four stitches to the colon and to both the anterior rectal sheet. The stoma is attached to the skin similarly to CG patients."
15763422|NCT04749316|Procedure|AcuTENS|Stimulation of acupuncture points with TENS machine
15763423|NCT04749303|Procedure|Large Screen|Large screen size is 4x larger than standard screen, we hope that the colonoscopies carried out with large screens will confer to better lesion detection
15763424|NCT04749290|Other|Study Formula|Study infant formula for term infants containing OPO and CPP
15763425|NCT04749277|Other|CAD EYE® (Fujifilm, Europe, Gesellschaft mit beschränkter Haftung, Dusseldorf, Germany)|"Methods plan
~Phase 1. Brief virtual chromoendoscopy training on the characterization of colorectal polyps (WLI, LCI and BLI)
~Phase 2. CAD EYE® system applied during colonoscopy retrieval:
~2.1. CAD EYE® system OFF: Virtual chromoendoscopy (BLI) - independently characterization of a suspected polyp in WLI and BLI by the first endoscopist and by the second endoscopist (iconographic record) 2.2. CAD EYE® system ON: Characterization mode (BLI): Characterization of a suspected polyp by CAD EYE® and respectively level of characterization (1 to 3) (iconographic record) Phase 3. Histopathological evaluation (pathologist with gastrointestinal expertise): Resection and recovery of a suspected polyp for anatomopathological characterization"
15763426|NCT04749264|Behavioral|Mindfulness meditation retreat|6 to 7-days mindfulness retreat (Vipassana/insight meditation). The retreats are held in silence and led by senior teachers with many years of experience in teaching meditation. The focus of the retreat is the practice of mindfulness meditation while sitting and walking. Retreats include focused attention and open monitoring mindfulness meditation practices. Each retreat has a similar practice schedule thus the amount and nature of formal practice is mostly the same.
15763427|NCT04749251|Procedure|Individualized blood pressure management|During the EVT procedure, mean arterial blood pressure (MABP) is targeted to remain within +/- 10 % of a reference value using vasoactive drugs and/or fluids
15763428|NCT04749251|Procedure|Standard blood pressure management|During the EVT procedure, mean arterial blood pressure (MABP) is targeted to remain within a fixed range of 70-90 mmHg
15763429|NCT04749238|Device|NucleoCapture device|Device: 100 ml NucleoCapture selective DNA adsorber. Treatment with NucleoCapture in one arm
15763430|NCT04749212|Diagnostic Test|serum high-sensitivity Troponin I (TnI) and NT-Pro-Brain Natriuretic Peptide (NT-proBNP)|Both biomarkers will be determined in each patient preoperatively and at postoperative day 1 and day 2.Measurements will not necessarily be taken independently of other measurements, meaning that the addition of the biomarker could be included in routine pre or postoperative day-1 and day 2 blood tests.
15763431|NCT04749199|Behavioral|Enhanced mirror therapy|Participants of the enhanced mirror therapy group will perform complex, randomized, finger opposition and reposition movements, using the thumb, index, middle, ring, and little fingers, and will be shown a 35% blurred visual feedback through the computerized mirror therapy device. Each participant will receive a mirror training session for 60 minutes each day, three times per week for four consecutive weeks.
15763432|NCT04749199|Behavioral|Standard mirror therapy|Participants allocated to this group will perform simple, sequential finger opposition and reposition movements, using the thumb, index, middle, ring, and little fingers, and will be shown a clear image of the exercising hand. Each participant will receive a mirror training session for 60 minutes each day, three times per week for four consecutive weeks.
15763433|NCT04749186|Device|Compuflo Epidural Training Instrument|The intervention will consist of a Structured Didactic Model. It will include the following: two standardized video lessons (anatomy and technique), construction of a 3D epidural plastic module, practical training by using an epidural simulator with the CompuFlo Trainer instrument, and practical training with the eye-tracking assisted technique.
15763435|NCT04749160|Device|Connected device|Connected device is a smart watch (with accelerometer without location data).
15763436|NCT04749147|Other|Black and White Printed Survey|This survey will feature black and white text and graphics.
15763437|NCT04749147|Other|Red Printed Survey|This survey will feature red text and graphics.
15763438|NCT04749121|Device|UVC Irradiation|We used the Porcine epidemic diarrhea virus (PEDV) as the indicator virus .An N99 mask was contaminated by spraying or applying with the virus on the exterior and interior surface of each silicone mask. Also, 100 μl of the viral suspension was spotted onto the filter part of N99 masks. Following 20-30 minutes of drying, the silicone masks underwent each of the decontamination procedures which are ultraviolet-C (UV-C) irradiation and 70% alcohol treatment. For UV irradiation, N99 masks were placed in an UV-C incubator ) and were exposed for different times at 1, 10 and 20 minutes, respectively.Untreated control and treated N99 masks were analyzed for viral infectivity in VERO cell cultures. At 48 hours post-infection, cells were examined for evaluation the viral infectivity via observation of cytopathic effect. Results for each treatment express mean ± standard deviations of 3 biological replicates.
15763439|NCT04749121|Drug|UVC Irradiation|Bacterial and fungal sampling were obtained from the inside and outside surface areas likely to the frequently touched and close contact with the face of hospital personnel. The cultures were then isolated onto the blood agars and Mac Conkey agars, respectively. After incubation, the total number of bacterial and fungal colonies were counted, recorded, and selected different colonies.
15763440|NCT04749121|Device|Fit test|All the participants had to pass the initial fit test.After decontamination with UVC irradiation for 60 minutes, fit testing was conducted using qualitative fit test (Bittrex Solution aerosol),
15763441|NCT04749121|Device|Tensile strength|We measured the tensile strength of the strap of the Silicone mask before and after the UVC irradiation to study the strength and reliliency of the strap
15763442|NCT04749108|Drug|Induction chemotherapy - modified FOLFIRINOX regimen|An induction chemotherapy (6 cycles) combining irinotecan 180 mg/m2, oxaliplatin 85 mg/m2, elvorin 200 mg/m2 followed by a 46-hour continuous infusion 2,400 mg/m2) will be delivered every 15 days (D1=D15).
15763443|NCT04749108|Other|Early tumor response evaluation by MRI volumetry|Two weeks after the CT completion, the tumor volume will be measured by MRI with specific software which automatically borders the tumor so as to determine the early tumor response. A centralized reassessment of all MRI exams will be systematically performed by two radiologists of the coordinator center.
15763444|NCT04749108|Radiation|Radiochemotherapy Cap 50|RCT Cap 50 will combine radiotherapy at a dose of 50 Gy by either conventional 3D or Intensity-Modulated RadioTherapy (IMRT) (2 Gy per fraction, 5 fractions per week during 5 weeks / 44 Gy in mini pelvis, and boost 6 Gy on reduced peritumoral volume) with concomitant oral capecitabine at 1600 mg/m2 per day delivered the days of radiotherapy treatment (2 daily intake).
15763445|NCT04749108|Procedure|Radical proctectomy with total mesorectal excision|The proctectomy can be performed by laparoscopic surgery or conventional laparotomy.
15763446|NCT04749095|Drug|Erector spinae plane block|bilateral ESP block will be injected with 20 ml of 0.25% bupivacaine
15763447|NCT04749095|Drug|sham subcutaneous infiltration|bilateral ESP block will be injected with 20 ml of normal saline
15763448|NCT04749069|Diagnostic Test|Comparison of pain intensity rating scale|Comparison of numerical pain intensity rating scale Comparison of faces pain rating scale Comparison of consumption of total amount of remifentanil
15763449|NCT04749056|Behavioral|EPAS (electronic psycho-oncological adapative screening program)|"Adaptive tests assess depression, anxiety and distress. Only items with highest information value are selected. Furthermore, patients fill in a checklist to report supportive care needs.
~The results page contains (i) the extent of distress and additional information to interpret these levels, (ii) a summary of the reported supportive care needs and (iii) individualized recommendations for the use of psychosocial services at the institution based on the care needs.
~The supportive care needs are transformed into concrete recommendations to use the adequate psychosocial service at the institution. Highly distressed patients are recommended to use psycho-oncological service irrespective of whether they have reported such a need in the check list. Physicians of highly distressed patients are recommended on their results page to talk with the patient about his/her psychosocial condition and further issues within such an appointment are suggested."
15763450|NCT04749043|Device|Oculus Quest 2 Virtual Reality Device|30 min VR experience exposure for labor analgesia. VR experiences include swimming in the ocean, walking through forests, engaging in 3D puzzles, exploring virtual lands, or interacting with musical objects
15763451|NCT04749043|Drug|Nitrous oxide|30 min exposure for labor analgesia
15763452|NCT04749030|Other|Faecal microbiota transplantation (FMT) capsules|The faeces is minimally processed through a series of centrifugation steps and dispensed into double-coated, acid resistant enterocapsules. A single treatment includes approximately 22 capsules (~50 grams of original donor faeces).
15763453|NCT04749030|Other|Placebo capsules|The placebo capsules are produced from a suspension of 50% glycerol, 40% sterile saline and 10% food coloring in enterocapusles
15763454|NCT04749017|Dietary Supplement|Experimental product consumption|Consumption of the experimental product 2 capsules daily, morning and evening (450 mg each capsule) for 60 days
15763455|NCT04749017|Other|Control product consumption|Consumption of control product of identical appearance 2 capsules daily for 60 days, morning and evening
15763456|NCT04749004|Behavioral|Promotion of physical activity|Provision of motivational stimuli (commitment contracts, nudges, financial incentives) to increase amount of steps taken
15763457|NCT04748991|Drug|Vernakalant|Post operative AF after cardiac surgery. Vernakalant 3mg/kg over 10 minutes followed by 2mg/kg over 10 minutes if still in AF.
15763458|NCT04748991|Drug|Amiodarone|Post operative AF after cardiac surgery. Amiodarone 150mg IV followed by 1 mg/min x 6 hours then 0.5 mg/min x 12 hours
15763459|NCT04748978|Procedure|hysteroscopy|OPPIum and Myolysis
15763460|NCT04748965|Diagnostic Test|Digital Subtraction Angiography|Compare optical coherence tomography lesion sizing and characteristics compared to traditional digital subtraction angiography
15763461|NCT04748952|Device|Densah burs|Osseodensification is a non-excavating implant site preparation technique. It creates a densified layer of surrounding bone through compaction autografting while simultaneously plastically expanding the bony ridge at the same time facilitating for placement of large diameter implants and also avoiding fenestration and dehiscence defects. The autografting occurs along the entire length of the osteotomy through a hydrodynamic process with the use of irrigation. The result is a consistently cylindrical and densified osteotomy.
15763462|NCT04748939|Biological|recombinant subunit herpes zoster vaccine|vaccine administration
15763463|NCT04748926|Drug|rilzabrutinib SAR444671|Pharmaceutical form: caplet Route of administration: oral
15763464|NCT04748926|Drug|rilzabrutinib SAR444671|Pharmaceutical form: Oral Formulation 1 tablets Route of administration: oral
15763465|NCT04748926|Drug|rilzabrutinib SAR444671|Pharmaceutical form: Oral Formulation 2 tablets Route of administration: oral
15763466|NCT04748913|Device|Radiographic examination|Standardized bitewing radiographs will be performed by the principal investigator
15763467|NCT04748913|Device|Scanning with DIAGNOcam|The surface of the selected teeth will be examined under near infrared light using the DIAGNOcam device
15763468|NCT04748913|Device|Scan with DIAGNOcam and Indocyanine|One the dye has been applied, a new series of images will be taken with Diagnocam
15763469|NCT04748913|Diagnostic Test|Visual-tactile exploration with separation|The point of contact will be open in the corresponding proximal area of the lesion using an elastic orthodontic separator
15763470|NCT04748900|Diagnostic Test|spirometer|different values are measured on the spirometer after training in respiratory physiotherapy.
15763471|NCT04748887|Other|oxidative stess markers|markers of oxidative stress , Superoxide Dismutase (SOD) and Malondialdehyde (MDA) by ( ELISA Kit SinoGeneClon Biotech Co.,Ltd Catalog No : SG- 10188) .
15763472|NCT04748874|Procedure|Immediate mNC-FET|In the immediate arm, patients undergo mNC-FET in the menstrual cycle immediately following oocyte retrieval and failed fresh embryo transfer or freeze-all.
15763473|NCT04748861|Other|Indoor Cycling (IC)|Participants will ride a Peloton bike 3x/week for 18 months.
15763474|NCT04748848|Drug|CC-90011|CC-90011 will be given PO on Days 1, 8, and 15 of continuous 4-week (28-day) cycle. The dose escalation is designed to explore three dose levels of CC-90011, for example 20, 40, and 60 mg as determined by Bayesian design.
15763475|NCT04748848|Drug|Venetoclax|Venetoclax is administered orally QD on Days 1 to 28 of each 28-day cycle with a brief dose ramp-up for Cycle 1 with the dosing of 100 mg on Day 1, 200 mg on Day 2, and 400 mg on Day 3. Venetoclax should be administered at 400 mg on subsequent days.
15763476|NCT04748848|Drug|Azacitidine|Azacitidine is administered on Days 1 to 7 of each 28-day cycle as an IV infusion or SC injection at 75 mg/m2
15763477|NCT04748848|Drug|Venetoclax|Venetoclax is administered orally QD on Days 1 to 28 of each 28-day cycle
15763478|NCT04748848|Drug|CC-90011|CC-90011 will be given PO on Days 1, 8, and 15 of continuous 4-week (28-day) cycle at the recommended phase to dose of CC-90011 confirmed in dose escalation.
15763479|NCT04748822|Other|questionnaires|The Alcohol Quality of Life Scale (AQoLS) will be completed at baseline and at 6-month follow-up. Alcohol status (relapse/abstinence) will be assessed at 6 months.
15763480|NCT04748809|Other|Diet 1|Dietary intervention
15763481|NCT04748809|Other|Diet 2|Dietary intervention
15763482|NCT04748796|Other|echocardiography|Full echocardiography will be performed at baseline and during the follow-up at H1, H3, H6 and H12.
15763483|NCT04748796|Drug|Landiolol|Patients randomized to the experimental group will be treated according to the standard of care plus for 2 days with landiolol IV started at a dose of 1 microgram/kg/min and progressively increased every 10 minutes to a maximum of 40 micrograms/kg/min.
15763484|NCT04748783|Other|Water|Subject participants will rinse mouth one time for 60 seconds with 10 mL of sterile water.
15763485|NCT04748783|Other|Peroxyl|Subject participants will rinse mouth one time for 60 seconds with 10 mL Peroxyl (1.5% w/v hydrogen peroxide) rinse
15763486|NCT04748783|Drug|Periogard|Subject participants will rinse mouth one time for 60 seconds with 10 mL Periogard (0.12% Chlorhexidine Gluconate) rinse.
15763487|NCT04748783|Other|Colgate Total Zero|Subject participants will rinse mouth one time with Colgate Total Zero Fresh Breath (0.075% Cetylpyridinium Chloride) 20ml for 30 seconds
15763488|NCT04748757|Drug|recombinant human annexin A5|recombinant human annexin A5, manufactured as SY-005
15763489|NCT04748757|Drug|Placebo|Normal saline 50 ml
15763490|NCT04748744|Combination Product|Butyrylcholinesterase|Value of Butyrylcholinesterase as a Marker of Surgical Site Infection Following Surgery for Colorectal Diseases
15763491|NCT04748731|Behavioral|Internet mentalization-based video feedback intervention to improve parental sensitivity in mother-infant dyads with maternal depressive symptoms|a weekly online brief intervention using video-feedback and psycho-educational materials on early parenting
15763492|NCT04748731|Behavioral|Psycho-Educational Intervention|Reception of psycho-educational materials
15763493|NCT04748718|Other|Exercise-based injury prevention program|~10-minute, 4+ times/week exercise-based injury prevention program. Includes flexibility, strengthening, balance, agility and plyometric exercises.
15763494|NCT04748705|Drug|IMC-1|Patients will take 1 tablet twice daily, each morning and evening, of randomly assigned study drug orally starting on Day 1 through study duration.
15763495|NCT04748705|Drug|Placebo BID Tablet|Patients will take 1 tablet twice daily, each morning and evening, of randomly assigned study drug orally starting on Day 1 through study duration.
15763496|NCT04748692|Procedure|Local exercise therapy|The local exercise therapy group will focus on strengthening knee and hip muscles three times a week for 6 weeks. Once a week, patients will train with the support of a physiotherapist. The physiotherapist gradually increases the intensity of the exercises improving muscle endurance. The exercises will be supplemented with mobilisations of the patellofemoral joint. Twice a week, patients train at home following a prescribed exercise program writing down their work-out in an exercise journal.
15763497|NCT04748692|Procedure|Spinal manual therapy|The spinal manual therapy group will be treated one a week for 6 weeks. Before the first intervention an experienced manual therapist performed a clinical examination of the lower back, SIJ, hip and knee. Anatomical maps showing innervation areas of spinal nerve roots will be used to explain the regional interdependence model in the treatment of anterior knee pain. Manual therapy treatment will include manipulations of the thoracolumbar (T12-L3) region or SIJ as well as hip joint. Manipulation will be conducted if a restriction of range of motion will be found in any of the regions. Patients will also be asked to do home exercises focusing on mobilizing the thoracolumbar region and to write down their performance in an exercise journal.
15763498|NCT04748679|Behavioral|Worry Intervention|The worry intervention is weekly individual therapy with a trained therapist
15763499|NCT04748679|Behavioral|Befriending|The worry intervention is weekly individual therapy with a trained therapist
15763500|NCT04748666|Behavioral|Problem Solving Training|Problem Solving Training (PST) is a metacognitive strategy training approach, grounded in self-management theory, that teaches a simple, systematic method for evaluating problems, generating and selecting solutions, developing specific goals and action plans, and evaluating and revising plans as needed.
15763501|NCT04748653|Behavioral|Multi-component reintegration intervention|The intervention incorporates health education, psychosocial counseling, physiotherapy and economic investment.
15763502|NCT04748640|Procedure|Gamma Knife VIM thalamotomy|Ablation of contralateral VIM nucleus of thalamus with GK using a frame-based, Gamma Knife Perfexion or Icon unit (Elekta, Stockholm, Sweden).
15763503|NCT04748614|Other|Cost|ICU cost
15763504|NCT04748601|Drug|Qudexy XR|Extended-Release Capsule
15763505|NCT04748601|Drug|Placebo|Qudexy XR Matching capsules
15763506|NCT04748588|Drug|Anti-SARS-CoV-2 mAb|"Casirivimab/imdesimab 1200mg/1200mg OR sotrovimab 500mg OR bamlanivimab 700mg IV x1.
~Casirivimab/imdesimab (REGN) and sotrovimab will be the default agents used (according to local availability) unless both unavailable AND virus strain known to be native or alpha (B.1.1.7) in which case bamlanivimab can be used."
15763507|NCT04748575|Dietary Supplement|Acai smoothie|Smoothie containing 150g acai pulp
15763508|NCT04748575|Dietary Supplement|Placebo smoothie|Control smoothie matched nutritionally (macronutrients) and sensorially to the acai smoothie.
15763509|NCT04748562|Drug|Progesterone|Taking prontogest vaginally
15763510|NCT04748549|Other|Virtual Reality Immersive Relaxation|The VR software developed allows patients to select from scenery such as mountains, the beach or from a selection of short videos, which are intended to promote relaxation.
15763511|NCT04748549|Other|Immersive Audio Experience|A study team member will play from a library of music or other audible content (audiobook, podcast) that was preselected by the patient.
15763512|NCT04748549|Other|Sham Virtual Reality Experience|Subjects will wear VR headsets and headphones but will not view any content or listen to any audible content.
15763513|NCT04748536|Drug|IRL201104|lyophilised powder for reconstitution for IV dosing
15763514|NCT04748536|Drug|Placebo|Matching placebo for IRL201104
15763515|NCT04748523|Drug|Mirtazapine|arm to receive 15 to 30 mg of Mirtazapine for a period of 8 weeks.
15763516|NCT04748523|Drug|Placebo Oral Tablet|arm to receive 15 to 30 mg of Placebo for a period of 8 weeks.
15763517|NCT04748510|Procedure|Functionally Aligned Total Knee Arthroplasty|Femoral + tibial osteotomy planned for equal resection of femoral condyles to replicate patient anatomy. In coronal plane, distal femoral resection of 6.5mm subchondral bone from medial + lateral condyles, adjusted 1-3mm for compensation of wear. Proximal tibia, 7mm resection from subchondral bone from medial + lateral tibial plateau. Sagittal plane, resection angle determined intraoperatively to closely match native femoral flexion + tibial slope. Axial plane: posterior femoral resection 6.5mm from the subchondral bone of medial and lateral posterior condyles. Tibial rotation aligned to Akagi's line. Adjustments will be made to bony alignment to balance soft tissues within boundaries of 6° varus/3° valgus HKA alignment. Femoral component alignment limited to 6° valgus/3° varus in coronal plane. Tibial alignment limited 6° varus/3° valgus in coronal plane. Combined flexion of components limited to 10° flexion. Soft tissue release if balance within boundaries not achieved.
15763518|NCT04748510|Procedure|Mechanically Aligned Total Knee Arthroplasty|Tibial and femoral osteotomies in the coronal plane will be planned perpendicular to the tibial and femoral mechanical axes respectively to achieve neutral overall alignment. Soft tissue balance will be assessed and minor adjustments to bony alignment made to balance the knees with a maximal adjustment of two degrees valgus and two degrees varus of coronal alignment from neutral. Femoral rotation will be planned to surgical epicondylar axis and adjustments to rotation made to allow equal flexion and extension balance (to within 1mm). If balance can not be achieved within these boundaries then soft tissue release will be undertaken. In the sagittal plane, 0-3° degrees of posterior tibial slope and 0-5° of femoral component flexion will be used to optimise implant sizing whilst preventing notching. In the axial plane, the tibial component aligned to Akagi's line, which connects the medial border of the patellar tendon attachment to the middle of the posterior cruciate ligament.
15763519|NCT04748497|Other|Standardization of evaluation and follow-up|"Standardization of evaluation and clinical and sportive follow-up of athletes.
~Made-to-measure technical supports will be tested regarding the Paralympic regulations."
15763520|NCT04748484|Device|KCC Active or inactive|Depending of the randomization, the KCC will be active or inactive, and will provide heat when active, but the patient won't know if the medical device is active or not. The battery charge indicator will work the same whether the device is operating or not.
15763521|NCT04748471|Biological|mRNA-1273|SARS-CoV-2 vaccine
15763522|NCT04748458|Device|Conical tapered stem|Implantation of conical tapered stem
15763523|NCT04748445|Diagnostic Test|SARS-CoV-2/Influenza/RSV RT-PCR|nasal swab
15763524|NCT04748419|Radiation|consolidative hypofractionated radiation therapy (hfRT)|Consolidative hfRT will start from 6.5Gy x 2 fractions and dose escalate to 10Gy x 2 fractions in a 3+3 design
15763525|NCT04748419|Drug|Durvalumab 50 MG/ML|Durvalumab 10 mg/kg via a 60-minute iv infusion every two weeks ± 3 days for up to 12 months
15763526|NCT04748406|Device|Extracorporeal Shock Wave Therapy(ESWT)|Group 2 (n = 35) will be applied 1 session per week for 3 weeks, 3 sessions of ESWT (1.8 bar, 10.0 Hz, 2000 beats) + cold application + home exercise program will be applied.
15763527|NCT04748406|Other|Peloid therapy|Group 1 (n = 35) will be given 15 sessions of peloid therapy + cold application + home exercise program for 3 weeks, 5 days a week
15763528|NCT04748406|Other|Home Workout Program|Patients will be given a home exercise program consisting of eccentric strengthening exercises and stretching exercises, which are planned to increase resistance every week. The patients will be taught strengthening exercises for forearm pronation-supination with wrist extensors and a home exercise program will be started 3 sets of 10 repetitions per day.
15763529|NCT04748406|Other|Cold application|At the beginning of each treatment, gel ice packs are wrapped with a moist towel and placed around the elbow joint for 15 minutes. will be applied.
15763530|NCT04748380|Other|CRC decision aid pamphlet|A newly developed 8-10 page decision aid pamphlet that discusses:1. Information on CRC; 2. Information about risk and benefits including the 10-year lag-time to benefitting from CRC screening; 3. Information to help patients evaluate CRC screening options (colonoscopy or stool testing); 4. Possible outcomes relevant to LE and health status. In addition, there will be a values clarification exercise
15763531|NCT04748380|Other|Home Safety Pamphlet|The home safety information pamphlet is a 2-page fact sheet on home safety tips for older adults, and was designed by the AGS Health in Aging Foundation. It includes information in seven areas to help older adults stay safe in their homes. Areas include but are not limited to fall prevention and safety proofing homes. It has been used successfully in prior studies of DAs as a control intervention
15763532|NCT04748367|Device|Virtual Reality Headset|Virtual Reality Headset running SILVER software
15763533|NCT04748354|Behavioral|Otago Exercise Program|An individualized and home-based program of progressive strength and balance training exercises delivered by a physical therapist
15763534|NCT04748354|Other|Usual Care|Clinical care provided by a geriatrician.
15763535|NCT04748341|Other|Pedagogical Framework (Learn, See, Practice, Prove, Do, and Maintain)|"The Learn, See, Practice, Prove, Do, and Maintain (LSPPDM) pedagogy is acting as a guiding path for educators in teaching and learning procedural skills. It is synthesized after intensely reviewing the literature comprises steps. In the 1st step, learners learn through didactic lectures, further proceeding to see procedural videos. The 3rd step, Practice expose learners to perform the skill on a simulator. In the 4th step Prove the learner proves the skill. The 5th step Do comprise real-life exposure through the clinical rotation. Then, finally the 6th stepMaintain the learner maintains skill supplemented with simulation as needed."
15763536|NCT04748341|Other|Traditional Method|"The traditional method group learns through 2-step method.
~didactic lectures on neonatal resuscitation were delivered.
~Practice skill on mannequins"
15763537|NCT04748328|Procedure|ACL Reconstruction surgery and Rehabilitation Treatment|ACL Reconstruction surgery is a procedure to treat ACL injury by replacing the torn ligament with another. ACL Rehabilitation treatment is a procedure to treat ACL injury by muscle strengthening and exercise
15763538|NCT04748315|Other|SEMT(1:1)|Soccer trainning protocolo will be performed on an work to rest ratio 1:1 and the trainning volume will consist of 1 set and 6 repetitions per set
15763539|NCT04748315|Other|SEMT (1:3)|Soccer trainning protocolo will be performed on an work to rest ratio 1:3 and the trainning volume will consist of 1 set and 6 repetitions per set
15763540|NCT04748289|Device|ICU Cockpit software testing|"the ICU Cockpit Software Platform is intended to be used for monitoring of patient characteristics and vital physiological parameters in patients at the Neurointensive Care Unit of the University Hospital Zurich.
~Furthermore, three different applications for prognostication and prediction of complications will be tested:
~ICU Cockpit COVID-19 for remote monitoring of isolated patients,
~ICU Cockpit Stable State for a comprehensive visualization of vital parameters and as additional aid in early detection of imminent critical complications
~ICU Cockpit Cerebral Ischemia for the prediction of delayed DCI in patients with subarachnoid hemorrhage (SAH)."
15763541|NCT04748276|Drug|FDA-approved selective-serotonin reuptake inhibitors (SSRIs) and selective-norepinephrine reuptake inhibitors (SNRIs)|Protocol-approved antidepressant treatments (ADT) will be prescribed in accordance with standard of care, whenever possible following dosing recommendations within the Study Formulary and Prescribing Guidelines (Sertraline 100 mg/day; Citalopram 20 mg/day; Escitalopram 10 mg/day; Fluoxetine 20 mg/day; Paroxetine 20 mg/day; Duloxetine 60 mg/day; Buproprion 300 mg/day; Desvenlafaxine 50 mg/day; Venlafaxine 150 mg/day). ADTs may be up or down-tapered as necessary.
15763542|NCT04748263|Other|No intervention. Only survey and normal use of eye-tracking|"The study is conducted in accordance with usual practices of eye-tracking and neuropsychological evaluations carried out at the Center Rainier III.
~Eye-Tracker® is used at the Centre Rainier III since August 2014. It is a non-invasive device for eye movements recording, allowing doctors and researchers to measure standard parameters related to eye movements. Developed by the Eye Brain Company (France), this is a Class IIa medical device, CE marking, according to Annexe IX of the directive 93/42/CE."
15763543|NCT04748250|Device|Acupuncture needles|Standard acupuncture needle which is 3 cm long with diameter o.3 mm
15763544|NCT04748250|Dietary Supplement|Soy phytoestrogens|100 millilitre of soy milk every day or 100 gram of cooked soy beans per day.
15763545|NCT04748237|Diagnostic Test|Coronary computed tomopraphic angiography|CCTA as soon as possible, preferably within 24 hours, but not later than within 7 days.
15763546|NCT04748224|Drug|Bupivacaine 0.25% Injectable Solution|a local anesthetic drug
15763547|NCT04748224|Drug|bupivacaine plus dexmedetomidine|bupivacaine is a local anesthetic drug plus dexmedetomidine is a new generation highly selective α2-adrenergic receptor (α2-AR) agonist that is associated with sedative and analgesic sparing effects
15763548|NCT04748211|Procedure|Infraclavicular Block|USI and neurostimulator guided infraclavicular block, 10 ml 2% lidocain and 10 ml 0.05% marcaine was administered for local anetshesia. After the block was administered MAP, HR, TAV, BAD, BAA, BF, PI and rSO 2 values were measured and recorded at the 10th, 20th, and 30th minutes.
15763549|NCT04748211|Procedure|Interscalen Block|USI and neurostimulator guided interscalen block, 10 ml 2% lidocain and 10 ml 0.05% marcaine was administered for local anetshesia. After the block was administered MAP, HR, TAV, BAD, BAA, BF, PI and rSO 2 values were measured and recorded at the 10th, 20th, and 30th minutes.
15763550|NCT04748198|Procedure|Intracorneal ring segment implantation|Surgical procedure for keratoconus treatment. A tunnel is created in the corneal stroma with femtosecond laser and ring segments are implanted in the corneal stroma
15763551|NCT04748172|Biological|SARS-CoV-2 virus vaccines|mRNA SARS-CoV-2 virus vaccines ( By Pfizer or Moderna)
15763552|NCT04748172|Diagnostic Test|AMH sampling|Blood sample for AMH on recruitment and after three months
15764483|NCT04740580|Dietary Supplement|Alanine|The placebo arm will supplement Alanine
15763553|NCT04748159|Other|Prone position/ Abdominal position|Standardized positioning of the infant in the prone position respectively abdominal position. Depending on age and size, one or two rolled towels are placed lengthwise under the baby. Both arms are placed cranially in U-position towards the head. Since the position of the head has no significant influence on lung ventilation, the head is placed according to the infant's tolerance.
15763554|NCT04748146|Other|Brain stimulation|Theta-burst stimulation will be applied to selected regions of distributed networks to test whether distal stimulation can modulate hippocampus-mediated episodic recollection.
15763555|NCT04748133|Device|acupuncture needles|"Site of acupuncture points:
~Du 26: At junction of the upper and middle third of philtrum.
~Ren 17: On the midline level with the 4th intercostal space midway between the nipples.
~LI4 (Large Intestine 4): On the dorsum of the hand, between the 1st and 2nd metacarpal bones
~HT7 (Heart 7): On the ulnar end of the transverse crease of the wrist, in the small depression between the pisiform and ulna bones
~LV3 (Liver 3): On dorsum of the foot in a depression distal to the junction of the 1st and 2nd metatarsal bones.
~ST36 (Stomach 36): Antero-lateral leg, 1 middle-finger breadth next to the anterior crest of tibia, 3 cun under the depression lateral to the patellar ligament.
~PC6 (Pericardium 6): Palmar aspect of the forearm, between the tendons, 2 cun away from the transverse crease of the wrist"
15763556|NCT04748133|Other|placebo|no treatment
15763557|NCT04748120|Procedure|Operative management|Patients will undergo surgical removal of the affected organ. The initial approach will be in a minimally invasive, laparoscopic fashion. If necessary, conversion to an open operation may be performed. These patients will be treated preoperatively and postoperatively with similar antibiotic regimens, however the duration of antibiotic therapies will be dependent on factors such as intraoperative findings, resolution of laboratory abnormalities, and tolerance of oral medications.
15763558|NCT04748120|Procedure|Non-operative management|"Patients will be treated with 3 days of intravenous antibiotics followed by 7 days of oral antibiotics, as described below:
~Non-penicillin allergic patients
~piperacillin/tazobactam 3.375g IV every 6 hours for 3 days
~amoxicillin/clavulanate 875/125mg by mouth every 12 hours for 7 days
~Penicillin allergic patients
~ertapenem 1g IV every 24 hours for 3 days
~ciprofloxacin 500mg every 12 hours AND metronidazole 500mg every 8 hours for 7 days
~Patients may be considered to have failed non-operative management (e.g. treatment failure) if they experience absence of clinical improvement, worsening abdominal pain and/or localized/diffuse peritonitis in the judgment of the treating surgeon at any point within the study window. If this occurs, then surgeons may proceed with rescue appendectomy or percutaneous drainage in the setting of appendicitis, or with placement of a percutaneous cholecystostomy tube in the setting of acute cholecystitis."
15763559|NCT04748107|Diagnostic Test|Impendence Cardiography|ICG is a noninvasive method of determining the amount of blood flow using the Non-Invasive Cardiac System - Cardiac Surveyor (NICaS) system, which provides an assessment of the cardiovascular system, respiratory system, and fluid retention.
15763560|NCT04748094|Device|Compression belt|The abdominal belt is fastened around the lower abdomen and inflated (like an inner tube) to apply pressure to the belly and reduce the motion associated with respiration (breathing)
15763561|NCT04748094|Other|Visual Guided Breath-hold|A small tracer will be place on the lower abdomen that will feedback to a computer screen that will have graphics to show you if the participant is in breath-hold or not.
15763562|NCT04748081|Procedure|hepatectomy|hepatectomy (ICD-9-CM procedure code: 50.2, 50.22, 50.3 and 50.4)
15763563|NCT04748068|Device|7-Fr Glidesheath Slender|The 7 Fr Glidesheath Slender is a recently developed thin-walled radial sheath. It combines an ID of 2.46 mm, with an OD of 2.79 mm, representing thereby the thinnest 7 Fr sheath currently available on the market
15763564|NCT04748068|Device|Cordis 7-Fr radial sheath|Avanti+ Catheter Sheath Introducer, Cordis, USA, outer diameter: 3.02 mm
15763565|NCT04748042|Drug|Abiraterone|Abiraterone 1000 mg by mouth per day for approximately 6 months.
15763566|NCT04748042|Drug|Prednisone|Prednisone 5 mg by mouth per day for approximately 6 months.
15763567|NCT04748042|Radiation|External Beam Radiotherapy|External beam radiotherapy, dose will depend on lesion location. Completed within 40 days of study start.
15763568|NCT04748042|Biological|Androgen Deprivation Therapy (ADT)|ADT by luteinizing hormone-releasing hormone (LHRH) agonist or antagonist for 6 months.
15763569|NCT04748042|Drug|Olaparib|Olaparib tablets 300 mg by mouth twice a day for approximately 5 months.
15763570|NCT04748029|Other|Systemic immune inflammation index|The systemic immune inflammation index (SII) was calculated using the formula, SII = platelet count x neutrophil count / lymphocyte count. Systemic immune inflammation index (SII) is a new index related to systemic inflammation calculated by the numbers of lymphocytes, neutrophils and platelets in peripheral blood.
15763571|NCT04748016|Other|3D printed (3DP) bone models + CT imaging|In addition to CT-MPR and CT-3DR, 3DP models will be used for surgical planning and intraoperative visualization.
15763572|NCT04748016|Other|CT imaging|CT-MPR and CT-3DR used for surgical planning and intraoperative visualization.
15763573|NCT04747990|Procedure|Early Definitive Treatment|defined as treatment in accordance with the current guidelines (cholecystectomy or ERCP with endoscopic sphincterotomy during the same hospital admission or within 2 weeks of discharge)
15763574|NCT04747977|Drug|OTX-DED|0.2mg dexamethasone ophthalmic insert
15763575|NCT04747977|Drug|OTX-DED|0.3mg dexamethasone ophthalmic insert
15763576|NCT04747977|Drug|OTX-DED|Hydrogel vehicle ophthalmic insert
15763577|NCT04747964|Drug|STSP-0601 for Injection|Subjects will receive one single lowest dose of STSP-0601 for Injection following protocol requirements
15763578|NCT04747964|Drug|STSP-0601 for Injection|Subjects will receive one single low dose of STSP-0601 for Injection following protocol requirements
15763579|NCT04747964|Drug|STSP-0601 for Injection|Subjects will receive one single intermediate dose of STSP-0601 for Injection following protocol requirements
15763580|NCT04747964|Drug|STSP-0601 for Injection|Subjects will receive one single high dose of STSP-0601 for Injection following protocol requirements
15763581|NCT04747964|Drug|STSP-0601 for Injection|Subjects will receive one single highest dose of STSP-0601 for Injection following protocol requirements
15763582|NCT04747951|Combination Product|Concurrent Chemoradiotherapy|"50Gy in 25 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.
~Concurrent chemotherapy:
~Capecitabine 1650 mg/m2/d"
15763583|NCT04747951|Procedure|TME|Total mesorectal excision
15831275|NCT04194515|Drug|metformin|metformin treatment for one month
15763584|NCT04747951|Drug|consolidation chemotherapy|Intravenous infusion of oxaliplatin (130 mg/m2 over 2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 3 courses, 3 weeks per course
15763585|NCT04747951|Drug|adjuvant chemotherapy|Administration of l-LV (400 mg/m2) and oxaliplatin (85 mg/ m2) by intravenous infusion over 2 h, followed by rapid intravenous infusion (iv) of 5-FU (400 mg/m2) and then slow infusion (civ) of 5-FU (2400 mg/m2 over 46 h), is repeated every 2 weeks for 6-12 cycles
15763586|NCT04747938|Device|Energy accumulator|All subjects treated with thermal therapy using the Energy Accumulator by acupoint concepts. The course included 8 sessions of treatment, twice every week for 4 weeks. Each session lasted for 30-45 minutes. During heat therapy, the ceramic nozzle of the Energy Accumulator was lightly pressed in contact of the skin, without any contact medium, and moved slowly along the meridians with some circular movements.
15763587|NCT04747938|Behavioral|Home exercise program|Home exercises aimed at providing gentle mobilization at the shoulder and were capable of carrying out at home. Patients were requested to perform the movements on a daily basis within the first 4 weeks of treatment. Four movements were involved: Movement 1 - Pendular Exercise, Movement 2 - Circle Exercise, Movement 3 - Wall Climbing Exercise, and Movement 4 - Lie on bed and move both arms up and down.
15763588|NCT04747925|Other|Mulligan two leg rotation core muscle strengthning exercises|Group A :is receiving moist heat for the hamstrings muscles prior the Mulligan Two leg rotation technique for 10mins.Hold the position for 30 seconds, relax for 1 minute. Reps are given 3 repetitions. And 3 Sets at each session .core muscle strenthening exercises for back extensors and abdominals i.e Bridge curls ,table top ,abdominal crunches,back extension with arms supporting, is being performed. Position is being held for about 10 seconds and each exercise are performed with 10 repititions. Patient is being relaxed for 3 seconds between repetitions and 60 second rest between each exercise
15763589|NCT04747925|Other|mulligan bent leg raise technique, core muscle strengthning exercises|Group B is receiving moist heat for the hamstrings muscles prior the Mulligan Bent leg raise technique for 10 minutes. Hold the position for 30 seconds, relax for 1 minute. Reps are 3 repetitions. And 3 Sets at each session .Subject is being receive 2 weeks protocol. core muscle strenthening exercises for back extensors and abdominals i.e Bridge curls ,table top ,abdominal crunches,back extension with arms supporting, are being performed. Position is held for about 10 seconds and each exercise is performed with 10 repititions. Patient is being relaxed for 3 seconds between repetitions and 60 second rest between each exercise
15763590|NCT04747912|Drug|Inotuzumab ozogamicin|Inotuzumab ozogamicin, sold under the brand name Besponsa, is an anti-cancer drug used to treat relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
15763591|NCT04747912|Drug|Dasatinib|Dasatinib is a prescription treatment for adults with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).
15763592|NCT04747912|Drug|Dexamethasone|Dexamethasone is a steroid that prevents the release of substances in the body that cause inflammation.
15763593|NCT04747912|Drug|Methotrexate|Methotrexate is a chemotherapy drug that is used to treat certain types of cancer and leukemia.
15763594|NCT04747912|Drug|Vincristine|Vincristine, also known as leurocristine and marketed under the brand name Oncovin among others, is a chemotherapy medication used to treat various types of cancer such as acute lymphocytic leukemia, acute myeloid leukemia, Hodgkin's disease, neuroblastoma, and small cell lung cancer among others.
15763595|NCT04747912|Drug|Ponatinib|A drug used to treat chronic myelogenous leukemia (CML) and Philadelphia chromosome-positive acute lymphoblastic leukemia. It is used in patients whose cancer has the T315I mutation or whose cancer cannot be treated with other tyrosine kinase inhibitors. It is also being studied in the treatment of other types of cancer. Ponatinib blocks BCR-ABL, which may help keep cancer cells from growing and may kill them.
15763596|NCT04747912|Drug|Methotrexate for Injection|Methotrexate is a chemotherapy drug that is used to treat certain types of cancer and leukemia. When given intrathecally, it prevents leukemia cells entering the cerebrospinal fluid (CSF) around the spine and brain. Intrathecal chemotherapy is administered during a procedure called a lumbar puncture or through an ommaya reservoir (shunt).
15763597|NCT04747912|Procedure|Allogenic Stem Cell Transplantation|A procedure in which a patient receives healthy blood-forming cells (stem cells) from a donor to replace their own stem cells that have been destroyed by treatment with radiation or high doses of chemotherapy. In an allogeneic stem cell transplant, the healthy stem cells may come from the blood or bone marrow of a related donor who is not an identical twin of the patient or from an unrelated donor who is genetically similar to the patient. An allogeneic stem cell transplant is most often used to treat blood cancers, such as leukemia and lymphoma, and certain types of blood or immune system disorders.
15763598|NCT04747899|Other|Positional release technique|"Experimental group is given Positional Release Technique along with the hot pack, muscle stretching and posture correction.
~Positional release technique position will maintained for almost 90 seconds. This technique will be repeated for three times each session, with 10 sec relaxation, 3 days/week.
~Upper trapezius stretching 5 repetitions×1 set, 3 days/ week. Total of 3 sessions were given each consisting of 30 min.
~Posture correction in ADLs as well as in working place by advising correct sitting posture, the participants will advised to relieve muscle tension after every 20-30 minutes of work by getting up; stretching the arm, shoulder, neck, and back muscles."
15763599|NCT04747899|Other|Traditional physical therapy|"Hot pack for 15-mins. Upper trapezius stretching 5 repetitions×1 set, 3 days/ week. Total of 3 sessions are given each consisting of 30 min.
~Posture correction in ADLs as well as in working place by advising correct sitting posture, the participants will advised to relieve muscle tension after every 20-30 minutes of work by getting up; stretching the arm, shoulder, neck, and back muscles."
15763600|NCT04747886|Behavioral|WW Only|WW is a structured behavioral weight management program that focuses on diet, physical activity and mindset skills. The dietary approach is based on creating an energy deficit diet to produce weight loss while also being attentive to the quality of the calories. Specifically, the WW program assigns SmartPoints values to foods based on calories, sugar, saturated fat and protein. In addition, particular foods are assigned a points value of zero (0) to encourage a healthier eating pattern (e.g. fruits, vegetables, non-fat yogurt, fish).
15763601|NCT04747886|Behavioral|WW + PolyRules!|In addition to WW, participants will be asked to engage in daily cognitive training using the PolyRules! app for three months. They will be instructed to start with 20-min of daily cognitive training and to progressively increase their training time to 30-min.
15832489|NCT04184570|Other|Observational Trial|Observational Trial
15763602|NCT04747873|Behavioral|e-CBT|The focus of the sessions is placed on the connection between thoughts, behaviours, emotions, physical reactions, and the environment. We work on evaluating negative beliefs and thought processes and their relationship with depression. Our goal is to adjust the negative thinking so that participants can think about and adapt to the things that are happening to them. This allows them to adjust the way they behave and think about their problems in a way that is not as negative and replaces those thoughts and behaviours with potentially more realistic and productive ones. Participants will be offered e-CBT program over 12 weeks with approximately 30 slides in each module. Participants will complete pre-designed modules and homework assignments while receiving personalized feedback and asynchronous interaction with a therapist through the platform.
15763603|NCT04747873|Behavioral|Stepped Care|Stepped care procedure (see arm/group descriptions).
15763604|NCT04747847|Drug|Atorvastatin and anakinra|Anakinra up to 8 mg/kg/day and atorvastatin at 0.75 mg/kg/day in children with acute KD at least 1 year old with CAA
15763605|NCT04747834|Device|MICOR-304|The MICOR-304 offers a mechanical approach to lens fragmentation and aspiration which provides an alternative to phacoemulsification with no cavitation, no thermogenic energy in the eye, which can eliminate generation of heat inside the eye while maintaining the same minimally invasive surgical approach through a small clear-cornea 2.5 mm incision.
15763606|NCT04747821|Biological|Adsorbed COVID-19 (Inactivated) Vaccine|Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac
15763607|NCT04747808|Drug|LL-BMT1|Drug-printed contact lens in both eyes
15763608|NCT04747795|Drug|Vitamin C|IV
15763609|NCT04747795|Drug|Normal saline|IV
15763610|NCT04747782|Other|no interventions performed. Just collecting data, blood samples and post-mortem biopsies.|no interventions performed. Just collecting data, blood samples and post-mortem biopsies.
15763611|NCT04747756|Other|Virtual Village|The purpose of this study is to create a virtual village for people aging with HIV, and to pilot test the virtual village intervention as a final step.
15763612|NCT04747743|Other|a self structured questionnaire|A self structured questionnaire to assess knowledge of skeletal muscle use in dental practice
15763613|NCT04747730|Other|Transcendental Meditation training|The programme targets inmates in HMP Warren Hill who are eligible to learn the meditation technique, who are staying in prison for at least six months since the beginning of the programme and who provide the signed informed consent. The sample of eligible inmates is approximately 190 inmates out of 250 currently in the prison. Inmates will be contacted by the research team in prison during introductory sessions of the research intervention.
15763614|NCT04747717|Procedure|chemotherapy/surgery|NEO chemotherapy/interval debulking surgery/AD chemotherapy
15763615|NCT04747704|Behavioral|Three Principles Counseling|A 10-week insight-based program offered in prisons in a group setting for 2 hours each week. Approximately 15 - 20 adults or youth in custody participate at a time, led by two trained teachers. The curriculum is designed to teach an understanding of the mind and human experience for the purpose of reducing risk factors, uncovering resiliency and to promote emotional and psychological well-being for adults and youth in the criminal justice system. This is taught through a compilation of sessions that speak to the potential, ability and resilience inherent in every individual. Sessions include a mix of lessons, experiential learning, and group conversations.
15763616|NCT04747691|Diagnostic Test|Bedside gastric ultrasound|Bedside ultrasound exam of the stomach
15763617|NCT04747678|Drug|Ivermectin|retrograde study of common and rare adverse effects of multiple doses of ivermectin used during the coivd 19 pandemic in egypt
15763618|NCT04747665|Other|Patient and endoscopist reported experience|Exploration of patient and endoscopists experiences of colonoscopy.
15763619|NCT04747639|Other|500 ml glucose-depleted apple juice|
15763620|NCT04747639|Other|500 ml conventional apple juice|
15763621|NCT04747639|Other|250 ml glucose-depleted apple juice|
15763622|NCT04747639|Other|250 ml conventional apple juice|
15763623|NCT04747626|Device|B-SAFER|Simplified hybrid frozen elephant trunk repair will be performed by utilizing B-SAFER technique which involves a physician modified endovascular stentgraft to treat the proximal aorta in subjects with aortic disease involving multiple segments.
15763625|NCT04747600|Procedure|surgical resection|surgical resection
15763626|NCT04747587|Other|Reaching Session|"Two x 45 minutes sessions of reaching tasks. Patients in the stroke group will perform the task with the paretic arm using a weight reduction system, allowing movement in the horizontal plane.
~Subjects in the control group will perform the task with the randomly selected arm weighted at 80% of their maximum voluntary shoulder torque"
15763627|NCT04747574|Drug|EXO-CD24|The study active treatment is EXO-CD24 -exosomes (natural nano-sized vesicles secreted by human cells) that were engineered to overexpress CD24, aerosolized in normal saline for inhalation via a standard hospital-grade inhalation device, QD for 5 days.
15763628|NCT04747561|Drug|18F-PEG3-FPN|For clinically suspected or confirmed melanoma patients and healthy volunteers, integrated PET/MR imaging was performed using targeted melanin-specific imaging agent 18F-PEG3-FPN. Meanwhile, the general imaging agent 18F-FDG was compared with MR multi-sequence and multi-parameters
15763631|NCT04747535|Device|Auto-CPAP|AIrSense 10, Auto-CPAP, Minimum pressure 5 cm water, maximum pressure 10 cm water
15764962|NCT04736654|Other|Survey study|Headache Disability Questionnaire (HDQ) will be applied.
15763632|NCT04747535|Device|CPAP since before|A CPAP the patient uses since before because of previously diagnosed obstructive sleep apnea
15763633|NCT04747522|Drug|SARS-CoV-2 vaccine|SARS-CoV-2 vaccines currently on market, i.e. Pfizer/BioNTech and Moderna
15763634|NCT04747509|Other|Blackburn exercises|"Experimental group will include Blackburn exercises and hot pack for 10 minutes prior to the application of exercises; 3 sessions/week for a total of 4 weeks. Measurement will be taken at base level and after the last session, i.e. bilateral difference in lateral scapular slide test, serratus anterior and lower trapezius muscle strength, static measurements of scapula ROM, and pain and disability.
~These exercises will include prone horizontal abduction neutral and with full external rotation, prone horizontal scaption neutral and with full external rotation, prone horizontal external rotation, prone horizontal extension. All these exercises will be performed 3x15 repetitions with 30 seconds rest interval between each set."
15763635|NCT04747509|Other|Conventional Physical therapy|"Control group will include conventional physical therapy and hot pack for 10 minutes prior to the application of exercises; 3 sessions/week for a total of 4 weeks. Measurement will be taken at base level and after the last session, i.e. bilateral difference in lateral scapular slide test, serratus anterior and lower trapezius muscle strength, static measurements of scapula ROM, and pain and disability.
~These exercises will include push-ups on a stable surface, upward rotation shrugs and resisted scapular retraction. All these exercises will be performed 3x15 repetitions with 30 seconds rest interval between each set."
15763636|NCT04747496|Drug|Edoxaban|This is a non-interventional, observational study.
15763637|NCT04747483|Other|Extension Oriented Treatment Approach|"The EOTA intervention involves three components.
~The first component is a series of active extension- oriented exercises:
~Prone lying: Able to tolerate for 5 minutes, no pillow Prone lying on elbows: Able to tolerate for 5 minutes Prone press up exercise: 3 sets of 10 repetitions, move to end-range extension Repeated extension in standing: 3 sets of 10 repetitions, move to end-range extension The second component of the EOTA is subject education. Subjects are educated to maintain the natural lordosis of the lumbar spine while sitting, and are instructed to avoid prolonged sitting for greater than 20-30 minutes whenever possible.
~The third component of the EOTA is mobilization of the lumbar spine to promote lumbar extension. The mobilization component consist of a series of up to 20 graded oscillatory mobilizations performed with the subject prone by using a grade I - IV mobilization force as described by Maitland."
15763638|NCT04747483|Other|EOTA+ Traction|"Subjects in the EOTA + traction group receive the EOTA components described above with Mechanical lumbar traction.
~Intermittent traction being applied (30-sec hold, 10-sec rest) for 15 minutes. Traction started with 25% of the patients' body weight and increased until the patient indicated that the tolerance for pulling was reached, with a maximum of 50% of the total body weight.
~2 sessions being given per week for 3 weeks."
15763639|NCT04747470|Drug|GS-3583|Administered as an intravenous (IV) infusion
15763640|NCT04747457|Device|Research FibroScan|"After having obtained the patient's Informed Consent Form signature, the following 3 examinations will be done:
~Standard examination [Reference CE-marked FibroScan]: the operator will need to find an optimal measurement area, and perform 10 valid measurements.
~Standard examination [Research FibroScan]: the operator must take 15 valid measurements at the same measurement point as the one used for the examination with the Reference FibroScan.
~Exploratory examination [Research FibroScan]: the operator needs to perform15 invalid measurements to acquire data in non-optimal regions of measurement (lungs, vessels, intestines, ribs, edges of the liver)."
15763641|NCT04747444|Other|Anti-Gravity Treadmill|Treadmill in which the body weight percent placed on the lower extremities can be controlled
15763642|NCT04747431|Drug|PBFT02|PBFT02
15763643|NCT04747418|Procedure|Diagnostic Hysteroscopy|Collection of first 5 cc of normal saline from the output port during diagnostic hysteroscopy
15763644|NCT04747418|Procedure|Trans-vaginal ultrasound|Trans vaginal ultrasound performed immediately following the diagnostic hysteroscopy ( as sonohysterography)
15763645|NCT04747405|Other|therapy group|therapy group of maximum 8 people repeated twice
15763646|NCT04747392|Biological|SAL001|administrated once by subcutaneous injection
15763647|NCT04747392|Biological|FORSTEO|administrated once by subcutaneous injection
15763648|NCT04747353|Device|Catheter ablation procedure with heart 3D model|Device: Catheter ablation procedure performed as part of standard care, although with the addition of an image-based 3D heart model including detailed anatomy and primary ablation targets
15763649|NCT04747340|Behavioral|Training for Awareness Resilience and Action (TARA)|See arm-description
15763650|NCT04747340|Other|Standard treatment|See arm-description
15763651|NCT04747327|Behavioral|specific health incentive information 1 with facts|a brief message that describes a debate over whether to pay people a large financial incentive to vaccinate
15763652|NCT04747327|Behavioral|specific health incentive information 2 with facts|a brief message that describes a debate over whether to pay people a smaller financial incentive to vaccinate
15763653|NCT04747327|Behavioral|just facts|a brief message that describes vaccine safety
15763654|NCT04747327|Behavioral|requirement to vaccinate message|a brief message that describes vaccination is likely to be required for work, plus safety and efficacy vac info
15763655|NCT04747327|Behavioral|freedom to decide|a brief message that notes you have the freedom to choose if you want to be vaccinated, and also include safety and efficacy vac info
15763656|NCT04747314|Drug|Antidepressant|"The antidepressant treatment utilizes antidepressant medication to improve pain, function, and depression outcomes.
~The Antidepressant Treatment History Form (ATHF) will be used to assess adequacy of any prior antidepressant medication treatment and to assist the decision regarding which antidepressant to start. A medication flowchart will help serve as a guideline throughout the drug selection and dosing determination. Weekly assessments completed by subjects will help determine response, tolerability, and necessity for dose adjustment or medication change."
15763657|NCT04747314|Other|Enhanced Fear Avoidance Rehabilitation|The EFAR treatment utilizes physical therapy, pain education, and motivational messaging to improve pain, function, and depression outcomes. Subjects will engage in gradual exposure to exercises and activities they are apprehensive about, such as standing to wash dishes.
15763687|NCT04747145|Drug|Adjuvant Chemotherapy (Temozolomide)|Starting no sooner than 4 weeks after completion of chemoradiation, 150-200mg/m^2, days 1-5 of 28-day cycle, for minimum of six cycles and up to 12 cycles.
15764991|NCT04736420|Drug|Rivaroxaban|Rivaroxaban dispensing claim is used as the exposure group
15763658|NCT04747301|Device|Double-balloon catheter (UTAH CVX-RIPE) for cervical ripening|"Sweeping the membranes by UTAH CVX-RIPE® (Utah Medical Products, Inc, 7043 South 300 West, Midvale, Utah 84047 USA). The catheter will be inserted manually until the proximal balloon is in the cervical canal, the distal balloon should be intrauterine and in the extra-amniotic space. The intrauterine balloon is inflated with 40mL saline and retracted so that it rests against the internal oz. The proximal balloon should now be outside the external oz and is inflated with 20mL saline. If the balloons are correctly situated on both ends of the cervix, they can be inflated with up to 80mL saline each.
~Cardiotocograph will be performed 30min, 2 hours after insertion and every 6 hours. The balloon is placed for a maximum of 24 hours.
~If it is expelled in the first 12 hours and the patient has no contractions or still shows an unfavorable cervix, another balloon is placed for a maximum of another 24 hours.
~The patients will be examined in case of extremely painful or membranes ruptured."
15763659|NCT04747301|Drug|Dinoprostone 10mg (Propess)|"Propess® 10mg Vaginal delivery system (Ferring Controlled Therapeutics Ltd., 1 Redwood Place, Peel Park Campus, East Kilbride, Glasgow, G74 5PB, UK) is a vaginal insert containing 10mg of dinoprostone in a timed-release formulation (the medication is released at 0.3 mg/hour).
~A Propess vaginal system is inserted by a research doctors. As in the catheter procedure, Fetal Heart Rate is monitored 30min before and 2 hours after placement. Cardiotocograph and vaginal examination will be performed every 6 hours. The vaginal system is placed for a maximum of 24 hours.
~If it is expelled in the first 12 hours and the patient has no contractions or still shows an unfavorable cervix, another vaginal system is placed for a maximum of another 24 hours.
~The patients will be examined in case of extreme pain or membranes ruptured."
15763660|NCT04747288|Diagnostic Test|Traditional Chinese Medicine pattern|Autoimmune disease (AID) as Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) and non AIDDES Healthy Controls subjects will take the Traditional Chinese Medicine pattern diagnosis.
15763661|NCT04747288|Diagnostic Test|Traditional Chinese Medicine tongue diagnosis|Autoimmune disease (AID) as Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) and non AIDDES Healthy Controls subjects will take the Traditional Chinese Medicine tongue diagnosis.
15763662|NCT04747288|Diagnostic Test|Heart rate variability|Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the Heart rate variability.
15763663|NCT04747288|Diagnostic Test|Schirmer's test|Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the Schirmer's test.
15763664|NCT04747288|Diagnostic Test|Ocular Surface Diseast Index (OSDI)|Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the Ocular Surface Diseast Index (OSDI).
15763665|NCT04747288|Diagnostic Test|EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI)|Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI).
15763666|NCT04747288|Diagnostic Test|36-Item Short Form Survey (SF-36)|Autoimmune disease (AID) as Sjögren's syndrome (SJS) and Systemic lupus erythematosus (SLE) for comparing with the Dry eye syndrome (DES) subjects will take the 36-Item Short Form Survey (SF-36).
15763669|NCT04747262|Behavioral|SPACE|SPACE program, an evidence-based protocol that has been proven to be efficent in childhood anxiety disorders and OCD (Lebowitz, 2013; Lebowitz, Omer, Hermes & Scahill, 2014)
15763670|NCT04747249|Other|Psychological support|Psychological care will be based on a monthly interview lasting approximately 45 minutes for 6 months.
15763671|NCT04747236|Drug|Azacytidine|Azacytidine, 300 mg po daily on Days 1-14
15763672|NCT04747236|Drug|Romidepsin|Romidepsin, 14 mg/m2 as an intravenous infusion over 4 hours on Days 8, 15, and 22 of a 35-day cycle
15763673|NCT04747236|Drug|Belinostat|Belinostat, 1000 mg/m2 as an intravenous infusion over 30 minutes on Days 1-5 every 21 days.
15763674|NCT04747236|Drug|Pralatrexate|Pralatrexate, 30 mg/m2 as an intravenous infusion over a 3-5 minute push once weekly for 6 weeks of a 7 week treatment cycle.
15763675|NCT04747236|Drug|Gemcitabine|Gemcitabine, 1000 mg/m2 as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of a 28 day cycle.
15763676|NCT04747223|Other|Run Gait Retraining|Running step rate will be retrained by real-time biofeedback via a watch accelerometer. Recent literature showed that performing gait retraining by altering step rate reduces loading rates and joint stress that are associated with lower extremity injuries (Wilson et al 2014, Lenhart et al 2014, Heidersheit et al 2011).
15763677|NCT04747210|Behavioral|contextual one-on-one coaching|Training workshop and coaching one-on-one
15763678|NCT04747210|Behavioral|Trainig workshop|Ten-hour training workshop.
15763679|NCT04747197|Drug|EYP-1901|Intravitreal injection
15763680|NCT04747184|Other|DNA extraction and 16S rRNA sequencing|DNA extraction using QIAamp® DNA mini kit (QIAGEN) was done under aseptic techniques in the sterile room for all samples according to the manufacturer instructions. The DNA extracts for the 54 samples collected (27 from asthmatic patients and 27 from healthy subjects) were stored at -80° C in a sterile Eppendorf tubes until they were sent to the Molecular Research (MR DNA) Lab (Molecular Research LP, Shallowater, TX, USA) for sequencing.
15763681|NCT04747171|Drug|intrathecal Magnesium|intrathecal adjuvants to bupivacaine
15763682|NCT04747171|Drug|intrathecal dexamthasone|intrathecal adjuvants to bupivacaine
15763683|NCT04747171|Drug|intrathecal dexmedetomidine|intrathecal adjuvants to bupivacaine
15763684|NCT04747158|Biological|Convalescent plasma|COVID-19 convalescent plasma at admission, after confirmation of eligibility, 200 ml on day 1 and 2
15763685|NCT04747145|Device|Radiation|60 Gy to be delivered over 30 daily treatments in six weeks. Chemoradiation is to start no sooner than 3 weeks after surgery and not later than 8 weeks.
15763686|NCT04747145|Drug|Concurrent Chemotherapy (Temozolomide)|75mg/m^2 x 42 days (concurrent chemotherapy with radiation). Chemoradiation is to start no sooner than 3 weeks after surgery and not later than 8 weeks.
15763811|NCT04746053|Biological|blood sample|blood sample (5ml)
15763688|NCT04747132|Other|Telegeriatric intervention|Individualized, comprehensive and specialized counseling for older adults through the Internet
15763689|NCT04747119|Other|muscle energy technique|the patient was supine and the therapist fix the lower limb of the affected side then ask the patient to perform isometric contraction for abductors maintained for 3-5 seconds, then the patient was instructed to stop, exhale and relax then the therapist perform further adducted the patient's knee of the affected side as a stretching exercise for Three to five repetitions of these directions were performed.
15763690|NCT04747119|Other|conventional selected physical therapy|"life style modification
~Transcutaneous electrical nerve stimulation (TENS)
~Flexibility stretching exercises to the hip flexors"
15763691|NCT04747106|Biological|plasma exchange|when ADP inhibition >30%, plasma exchange, once or twice a week, 1000-1500ml plasma was exchanged for each time
15763692|NCT04747093|Biological|CAR-ITNK cells|CAR-ITNK cells will be infused over 10-15 minutes on Day 0.
15763693|NCT04747080|Drug|Dexamethasone|Dexamethasone 40 mg per day, 4 consecutive days (the 4-day course of dexamethasone is repeated in the case of lack of response by day 14).
15763694|NCT04747080|Drug|Tacrolimus|Tacrolimus is given at a dose of 0.03mg/kg·d, and the dose is adjusted to maintain the trough concentration of tacrolimus at approximately 3-5 ng/mL for 12 weeks.
15763695|NCT04747054|Drug|Pembrolizumab|Pembrolizumab 200 mg every 3 weeks until disease progression (as confirmed according to response evaluation criteria in solid tumors version 1.1 (RECIST v1.1)) or unacceptable toxicity. The treatment of pembrolizumab should not be delayed because of radiotherapy planning.
15763696|NCT04747054|Radiation|Loco-regional radiotherapy|The loco-regional radiotherapy will start at D8 after the first administration of pembrolizumab (D1) (if delayed, RT should be started no later than three weeks after the first administration of pembrolizumab, i.e. before the second administration of pembrolizumab if possible), with 54 Gy/18 fractions in the head and neck region. The volume of RT will include only involved loco-regional tumor region and no prophylactic neck volume will be necessary.
15763697|NCT04747041|Combination Product|CYSCONTROL/PHYTOCYST Herbal tea|Alternating every month from Day1 to Day15 cyscontrol and phytocyst herbal tea to prevent episode of cystitis
15763698|NCT04747028|Diagnostic Test|Dmf score|A chart to calculate the caries index
15763699|NCT04747015|Drug|Oxytocin|Oxytocin 10 IU I.V shot administered at the time of delivery of the anterior shoulder of the baby according to the WHO recommendation
15763700|NCT04747015|Drug|Oxytocin|5 IU units IM (WHO GDG recommendations,2012) and waiting for signs of placental separation then controlled cord traction (CCT)to the umbilical cord while applying simultaneous counter-pressure to the uterus, through the abdomen(Brandt Andrews maneuver)
15763701|NCT04747015|Procedure|cervical traction|sustained traction downward and posteriorly was applied to anterior and posterior lips of the cervix using ovum forceps for approximately 90 seconds. The traction should be adequate to allow the cervix to reach the vaginal introitus. Meanwhile (CCT ) is avoided and watchful waiting for signs of placental separartion till 90 seconds end
15763702|NCT04747002|Drug|DSP-7888|Cocktail peptide vaccine designed to induce cytotoxic T lymphocytes that recognize WT1 peptides
15763703|NCT04746989|Drug|Probenecid|Probenecid claim is used as the reference group.
15763704|NCT04746989|Drug|Allopurinol|Allopurinol claim is used as the exposure group.
15763705|NCT04746976|Drug|Diroximel Fumarate|As described in the arm.
15763706|NCT04746963|Drug|AXT107 0.1 mg|Single intravitreal injection of AXT107 0.1 mg/eye (low dose)
15763707|NCT04746963|Drug|AXT107 0.25 mg|Single intravitreal injection of AXT107 0.25 mg/eye (mid dose)
15763708|NCT04746963|Drug|AXT107 0.5 mg|Single intravitreal injection of AXT107 0.5 mg/eye (high dose)
15763709|NCT04746937|Drug|Nitazoxanide|nitazoxanide adjuvant to standard therapy
15763710|NCT04746937|Drug|Norfloxacin|Standard therapy
15763711|NCT04746924|Drug|Tislelizumab|Tislelizumab is a monoclonal antibody formulated for intravenous injection.
15763712|NCT04746924|Drug|Ociperlimab|Ociperlimab is a monoclonal antibody formulated for intravenous injection.
15763713|NCT04746924|Drug|Pembrolizumab|Pembrolizumab is a monoclonal antibody formulated for intravenous injection.
15763714|NCT04746924|Drug|Placebo|Placebo infusions will consist of a sterile, normal saline solution.
15763715|NCT04746911|Drug|ARQ-151 cream 0.3%|ARQ-151 cream 0.3% applied to chronic plaque psoriasis lesions once a day for 4 weeks
15763716|NCT04746898|Other|Virtual Reality Training|Students received their basic life support application training through virtual reality glasses with special software.
15763717|NCT04746898|Other|High Fidelity Simulation Training|Students received their basic life support application training through high fidelity simulator mannequins.
15763718|NCT04746898|Other|Low Fidelity Simulation Training|Students received their basic life support application training through low fidelity simulator mannequins.
15763719|NCT04746885|Dietary Supplement|DHA|Oral supplement
15763720|NCT04746872|Device|Alinity m HR HPV|Alinity m HR HPV
15763721|NCT04746859|Behavioral|Peer health coaching|Patients will receive ongoing support from a trained peer health coach (PHC) for 6 months after their BETTER prevention visit. The PHC will work collaboratively with the patient to help her follow through on a step-wise, personalized plan to achieve health goals that the patient identified with their prevention practitioner at their BETTER prevention visit. The PHC's approach will be informed by principles of brief action planning and motivational interviewing. PHCs will also provide social support, help to navigate to relevant information and community resources, and advise about options for self-monitoring (e.g., relevant applications that may be helpful to track health behaviours).
15763722|NCT04746859|Other|Usual Care|Patients will interact with their primary care providers (including their prevention practitioner) as usual and receive treatment, advice and/or support as they normally would after their BETTER prevention visit.
15763723|NCT04746833|Behavioral|SUMMIT|multicomponent web-based application focused on pain self-management skills
15763724|NCT04746833|Behavioral|control|My Pain Diary app
15763812|NCT04746040|Drug|Test|2 inhalations of Test and Reference product in each study period
15763813|NCT04746040|Drug|Reference|2 inhalations of Test and Reference product in each study period
15763814|NCT04746014|Diagnostic Test|Clearblue Pregnancy Test|Urine Pregnancy Test
15763815|NCT04746001|Diagnostic Test|Genomic sequencing|Sequencing data
15763725|NCT04746820|Other|single-center prospective pilot study|"fNIRS will be compared to evoked potentials in an experimental group consisting of unconscious neuro-intensive care patients and in a control group consisting of healthy, conscious subjects.
~To compare fNIRS with evoked potentials there are two test phases:
~The cerebral response to a somatosensory stimulus (peripheral nerve stimulation) is measured by fNIRS and SSEP
~The cerebral response to an auditory stimulus is measured by fNIRS and AEP"
15763726|NCT04746794|Behavioral|Population-level screening|"The study intervention involves having patients complete a familial cancer risk assessment survey. Those who are found to be at high risk will be offered genetic testing for a panel of hereditary cancers. A previvor plan will be created to assist patients and their providers in completing the appropriate follow-up for those with a mutation identified."
15763727|NCT04746781|Behavioral|Mobile 360° Video intervention|Using 360° Videos to educate participants about the effect of diabetes.
15763728|NCT04746781|Behavioral|Motivation and Problem Solving (MAPS)|Using Motivation and Problem Solving to help people enroll in the Diabetes Prevention Program.
15763729|NCT04746781|Behavioral|Risk notification/education|Sending participants (all of whom meet the diagnostic criteria for prediabetes) educational information about the condition.
15763730|NCT04746768|Combination Product|exercise and nutritional support|exercise and nutritional support program during an active support phase (0 to 6 months) followed by an empowerment phase (from 6 to 12 months)
15763731|NCT04746755|Device|Orthotic Insole: Lower Back|This Insole is a full-length shaped orthotic insole, with a heel cup and an arch support. The insole can cover several shoe sizes and can be cut to the correct size to fit in the shoe.
15763732|NCT04746755|Device|Orthotic Insole: Heel|This Insole is a horseshoe shaped flexible heel cup with a softer area where the heel would be expected.
15763733|NCT04746755|Device|Orthotic Insole: Knee to Heel|This Insole is a ¾ length rigid orthotic insole with a softer area where the heel would be expected. Each insole will cover several shoe sizes.
15763734|NCT04746755|Device|Orthotic Insole: Arch|"This Insole is a ¾ length shaped medical device with a softer area incorporated into the ball of foot and heel area and an external arch.
~support and 6-8 mm metatarsal dome. The slim fit insole runs from the heel along under the arch of the foot and reaches to just behind the toes to prevent squashing the toes in tight fitting shoes."
15763735|NCT04746742|Procedure|Tunneled Femoral Catheter (TFC) group|Patients with end-stage chronic kidney disease exhausted upper-extremity and chest-wall vascular accesses will be submitted to creation of a Lower-Extremity Hemodialysis Vascular either through application of tunneled femoral catheter
15763736|NCT04746742|Procedure|Femoro-femoral Arteriovenous graft (FF-AVG) group|Patients with end-stage chronic kidney disease exhausted upper-extremity and chest-wall vascular accesses will be submitted to creation of a Lower-Extremity Hemodialysis Vascular either through application of tunneled femoral catheter
15763737|NCT04746729|Other|No intervention|No intervention
15763738|NCT04746716|Other|Phone call|Phone call to the patient to complete quality of life scales
15763739|NCT04746703|Radiation|Magnetic Resonance Imaging|Pancreatic MRI will be performed in severe-obese patients with a planned bariatric surgery, before and 6 months after bariatric surgery.
15763740|NCT04746690|Other|Slider, tensioner neurodynamic mobilization techniques and stretching exercises of back, hamstrings and gastrocnemius|neurodynamic mobilization techniques of sciatic nerve and stretching exercises of back extensors, hamstrings and lower limbs for patients with chronic discogenic sciatica.
15763741|NCT04746677|Device|Endovascular aortic repair with a physician-modified endovascular graft (PMEG)|Endovascular aortic repair with a physician-modified endovascular graft (PMEG)
15763742|NCT04746664|Behavioral|Nutritional counselling|Individual-based nutrition counselling guided with the health belief model (HBM) and the theory of planned behavior (TPB) will be implemented.
15763743|NCT04746651|Other|Guided Self Help|Guided self help appointments with prison staff - 4x 30 minute appointments.
15763744|NCT04746638|Diagnostic Test|whole body study and SPECT with 99mTc-RM26|One single intravenous injection of 99mTc-RM26, followed by gamma camera imaging after 2, 4, 6 and 24 hours.
15763745|NCT04746612|Drug|HH30134|HH30134 administered orally on a continuous once daily(QD) in patients with advanced solid tumors
15763746|NCT04746599|Procedure|Autologous Fat Grafting|The trochanteric area or the periumbilical abdominal region represents the donor sites. Following Coleman's technique and after the administration of modified Klein solution, a skin incision is performed in the selected area. Adipose tissue is harvested and after suture the area is managed with an elastic-compressive dressing, to be kept in place for 5 days to prevent hematoma formation. The adipose tissue is the centrifuged at 920 × g for 3 min in sterile conditions. Only the intermediate layer containing adipocytes and stromal vascular component will be then injected using a blunt cannula. The terminal branches of the patient's leg arteries are mapped to facilitate graft placement. Under local anesthesia multiple injections of the adipose tissue formulation are inoculated 1 cm above the end of the terminal branch of the peroneal, anterior, and posterior tibial arteries.
15763747|NCT04746586|Other|Circulating MiRNA indentification|Identification of circulating miRNA useful to discriminate between worsening and stable forms of AIS
15763748|NCT04746573|Device|Natrox Topical Oxygen Therapy|Device delivering humidified oxygen directly to the wound bed
15763749|NCT04746560|Device|TEG®6S device with its Platelet mapping® cartridge|Platelet function monitoring using the TEG®6S device with its Platelet mapping® cartridge
15763750|NCT04746547|Drug|Dolutegravir 50 MG|Twice daily dolutegravir with rifampicin containing TB treatment
15763751|NCT04746521|Diagnostic Test|Multitest 6 color TBNK and BD Lyotubes|The Multitest 6 color TBNK allows us to count the population-specific B, T, NK cells
15763752|NCT04746495|Drug|Placebo|Participants will go through a 2-week wash-in period. During the wash-in period, the participant will be asked not to take their usual antihypertensive medications for their mild hypertension. After the 2-week wash-in period, the participants will begin a 4-week treatment period and will take a placebo once a day for 4 weeks. After the 4 weeks, the participants will have a 2-week wash-out period where they will be off the study treatment. After the 2-week wash-out period, the participants will begin the Eplerenone treatment for another 4 weeks.
15763816|NCT04746001|Diagnostic Test|Histological examination|Images for deep learning
15763817|NCT04745988|Drug|Lenvatinib|Lenvatinib will be administered at a dose of 20mg as oral dose, once a day.
15764992|NCT04736420|Drug|Warfarin|Warfarin dispensing claim is used as the reference group
15763753|NCT04746495|Drug|Eplerenone 50mg|Participants will go through a 2-week wash-in period. During the wash-in period, the participant will be asked not to take their usual antihypertensive medications for their mild hypertension. After the 2-week wash-in period, the participants will begin a 4-week treatment period of Eplerenone for 4 weeks. After the 4 weeks, the participants will have a 2-week wash-out period where they will be off the study treatment. After the 2-week wash-out period, the participants will then begin the Placebo treatment for another 4 weeks.
15763754|NCT04746482|Procedure|single visit root canal retreatment|cases that were subject to root canal retreatment performed in single visit
15763755|NCT04746469|Behavioral|Delayed automated phone call|Cipher provides automated phone calls to patients; in this case the script for Cipher was modified to provide patients a reminder to return FIT kits, allow patients to request a new kit in case they need a replacement, and to allow patients to provide information if they already completed CRC screening
15763756|NCT04746443|Other|NOT APPLICABLE (NA)|THE INTERVENTION GROUP IS NOT APPLICABLE TO THE CURRENT STUDY DESIGN
15763757|NCT04746430|Drug|Dexamethasone|6 mg dexamethasone prescribed during ten days and as a precaution combined with electronic monitoring of saturation and other signs and symptoms
15763759|NCT04746391|Device|Dialyzer type|Fiber blocking and dialyzer clearance is calculated in two different commercially available dialyzers
15763760|NCT04746391|Other|Dialysis duration|Fiber blocking and dialyzer clearance is calculated for three different dialysis durations
15763761|NCT04746378|Diagnostic Test|Computed Tomography, CSD|Measurement of the stone burden by cumulative stone diameter, the sum of linear longest diameters of all the stones to be treated within one patient as measured on the CT or by additional rendering software
15763762|NCT04746378|Diagnostic Test|Computed Tomography, SA|Measurement of the stone burden by surface area, the sum of surface areas of all the stones to be treated within one patient as measured on the CT or by additional rendering software
15763763|NCT04746378|Diagnostic Test|Computed Tomography, 3D|Measurement of the stone burden by volume of all the stones to be treated within one patient, as measured on the CT or by additional rendering software
15763764|NCT04746365|Drug|ivermectin|ivermectin is anthelmintic
15763765|NCT04746365|Drug|hydroxychloroquine|hydroxychloroquine is antimalarial.
15763766|NCT04746365|Drug|Placebo|Standard treatments
15763767|NCT04746352|Procedure|BES-SMFR|For the BES intervention, it was performed using the same Vishee neuro-muscle stimulator as the sEMG assessment with a vaginal probe was inserted into the vagina and placed close to the PFMs. At the same time, patients could learn about their neuromuscular activity through the biofeedback instrument, abdominal breathing for 5 sec was necessary when PFMs were overactive. BES was performed once every 2 days for 4 weeks.
15763768|NCT04746352|Procedure|BES|First, a standardized and structured vaginal examination was performed by digital palpation to identify pelvic floor active MTrPs, and then pain mapping was developed for the patient's use. Second, patients were required to participate in intensive training regarding myofascial release techniques. Following the training, SMFR was regularly performed by at home for 5 minutes daily for 4 weeks. SMFR was confirmed with patients at all their follow up visits.
15763769|NCT04746339|Drug|Apixaban 2.5 MG|Apixaban 2.5mg twice daily for 30 days
15763770|NCT04746339|Drug|Placebo|placebo twice daily for 30 days
15763771|NCT04746326|Procedure|Failure conservative treatment|Surgery was performed in patients who failed conservative treatment.
15763772|NCT04746326|Procedure|Surgery|Surgery was performed in patients who had generalized peritonitis and perforation.
15763773|NCT04746326|Other|Conservative treatment|Conservative treatment was performed in patients who had no generalized peritonitis and perforation.
15763774|NCT04746313|Biological|blood test|"to analysis prolactin in healthy subjects and scleroderma patients
~then to analysis in only scleroderma patients: thyroid-stimulating hormone (TSH), thyroxine (T4), luteinizing hormone (LH), oestradiol, follicle-stimulating hormone (FSH), BAFF (B-cell activating factor), IL-6 (interleukin 6) and endoglin"
15763775|NCT04746300|Procedure|Biopsy|A biopsy will be taken from metastatic tissue, which will be used for DNA sequencing
15763776|NCT04746300|Procedure|Blood sample|Blood samples will be taken for additional translational research
15763777|NCT04746287|Drug|CKD-510 single dose|Investigational drug
15763778|NCT04746287|Drug|CKD-510 food effect|Investigational drug
15763779|NCT04746287|Drug|CKD-510 multiple dose|Investigational drug
15763780|NCT04746287|Drug|Placebo|Matching placebo
15763781|NCT04746274|Behavioral|Online large-group one-session multicomponent positive psychological intervention|The intervention is aimed at enhancing positive mental health by using components from positive psychology or positive psychotherapy. These include for exapmle using character strengths, savoring the moment, goal setting and goal attainment. The intervention is conducted in an online group format via videoconference with a duration of approximately 3 and a half hours.
15763782|NCT04746274|Behavioral|Online large-group one-session cognitive intervention targeting dysfunctional thoughts|The intervention is aimed at reducing dysfunctional thoughts by applying strategies known from the cognitive therapy of depression. These include for example identification of automatic thoughts and cognitive biases as well as evaluating evidence for and against automatic thoughts. The intervention is conducted in an online group format via videoconference with a duration of approximately 3 and a half hours.
15763783|NCT04746261|Behavioral|ASSIP + treatment as usual|"ASSIP:
~First session: Videotaped narrative interview focusing on the background to the suicidal crisis.
~Second session: Video playback. The patient and the therapist watch the recorded interview together, stopping the film regularly to add information. The patient is given a psychoeducational text to read and comment on as homework.
~Third session: Compilation of a written case formulation of the individual's vulnerability and triggering events that preceded the suicidal crisis. Individual preventive measures are developed by the patient and the therapist together and written down in a document that the patient keeps and which is attached to the patient's medical record.
~Fourth session (optional): Mini-exposure.
~Standardized letters: The therapist contacts the patient by letter during two years, every three months the first year and every six months the second year.
~Treatment as usual: As described bellow"
15763818|NCT04745988|Drug|Pembrolizumab|Pembrolizumab will be administered at a dose of 200mg as a 30-minutes IV infusion, Q3W (25 minutes to 40 minutes are acceptable).
15763784|NCT04746261|Other|Treatment as usual|Treatment as usual will be multidisciplinary and combine psychotherapy, pharmacotherapy and other treatments as well as referral to specialist psychiatry or primary care as required. At the first visit, a specialist or resident in psychiatry will assess the suicide risk as high, medium or high, based on the information from the referring psychiatrist, the standardized interview, the Columbia- Suicide Severity Rating Scale (C-SSRS) and Suicide Intent Scale (SIS) scales and the medical record. Based on the suicide risk assessment the follow up treatment will be divided into different levels.
15763785|NCT04746248|Other|Outpatient labor induction|The participants stay at home during til labor induction process and are admitted to hospital at the onset of labor or if a complication occur. Outpatient consultations once a day.
15763786|NCT04746248|Other|Inpatient labor induction|The participants are induced following standard inpatient care
15763787|NCT04746235|Drug|Decitabine and Cedazuridine|Given PO
15763788|NCT04746235|Drug|Venetoclax|Given PO
15763789|NCT04746222|Biological|Oral capsule faecal microbiota transplantation|Single dose of 30 oral capsules containing healthy donor stool from a stool bank
15763790|NCT04746222|Other|Placebo|Single dose of 30 oral placebo capsules
15763791|NCT04746209|Device|Alpha/Beta T-cell and B-cell depleted HCT|Device: Alpha/Beta T-cell and B-cell depletion
15763792|NCT04746209|Drug|Blinatumomab|28 day continuous infusion given on Day 100 post-HCT if no significant ongoing GVHD
15763793|NCT04746196|Other|Serum galectin-3 concentration was measured.|Serum galectin-3 concentration was measured using a commercial chemiluminescent microparticle immunoassay.
15763794|NCT04746183|Drug|CST-2: EIDD-2801|"CST-2 Phase Ib: EIDD-2801 will be administered orally, twice daily (BID) for 10 doses (5 or 6 days). The starting dose will be established based on safety and pharmacokinetics from the EIDD-2801-1001-US/UK study, and dose escalations may occur as described in this CST.
~Phase II: As per Phase Ib, with the dose determined by the recommended phase II dose."
15763795|NCT04746183|Drug|CST-2: Placebo|CST-2 Phase II: Placebo will be administered orally, twice daily (BID) for 10 doses (5 or 6 days).
15763796|NCT04746183|Drug|Nitazoxanide|"CST3A & CST3B Phase I: Nitazoxanide will be administered orally, initially twice daily (BID) for 14 doses (7 days). The starting dose will be 1500mg BID based on existing dose information, but dose adaptations may occur.
~Phase II: As per Phase Ib, with the dose determined by the recommended phase II dose."
15763797|NCT04746183|Drug|VIR-7832|"CST-5: Phase I, Single doses of VIR-7832 will be administered by intravenous (IV) infusion over 1 hour. The starting dose will be 50 mg, and dose escalations of 150 and 500 mg are anticipated, with escalation guided by emerging safety data and decision by the SRC.
~Phase II: As per Phase I, with the dose determined by the recommended phase II dose."
15763798|NCT04746183|Drug|VIR-7831|CST-5 Phase II: A 500 mg dose of VIR-7831 will also be given by IV infusion over 1 hour.
15763799|NCT04746183|Drug|CST-5: Placebo|CST-5 Phase 1, Phase II: Placebo given by intravenous infusion over 1 hour
15763800|NCT04746170|Other|Labor Dance|Pregnant women in the experimental group will be given a birth dance with music for 15 minutes per hour until the cervical opening starts from 3 cm (latent phase) and the cervical opening reaches 8 cm. The massage application will be made by the researcher to their waist and sacrum area with a ball massage glove.
15763801|NCT04746157|Other|Nurse intervention|Patients will undergo an individualized patient care plan conducted by a lead nurse. According to their results on the Stroke Riskometer and their cardiovascular risk factors, the nurse will prepare a phone call for the next two weeks with information and support adapted to each patient and their necessities. Phone calls will be repeated monthly until the sixth month, then, one more the ninth month and one last previous to the end of the treatment. Patients will be able to contact the reference nurse whenever they would need to.
15763802|NCT04746144|Procedure|Total knee arthroplasty|
15763803|NCT04746131|Drug|IMM0306|IMM0306 is an bi-specific antibody
15763804|NCT04746118|Behavioral|DIET CHANGE|Nutritional supervision will be carried out individually based on the Food Guide for the Brazilian Population, ensuring an accessible, hygienic and contextualized diet according to the subject's culture and physiology. The protocol includes an initial assessment to define the meal plan and individual reassessments every four weeks. In the first evaluation participants will receive an eating plan with a 20% reduction in the total calories consumed or even the equivalent of their daily energy needs with a distribution of macronutrients comprised of 65% carbohydrate, 15% protein and 20% fat. The intention is to promote a reduction in weekly consumption by about 2000 kilocalories (Kcal). The prescription and diet control plan will include and be conducted by a team coordinated by a clinical nutritionist.
15763805|NCT04746118|Behavioral|PHYSICAL ACTIVITY|The physical activity program will consist of daily walking sessions performed outdoors and on a flat surface suitable for hiking. Each session will last 70 minutes and will be performed between 55% -60% of the maximum oxygen consumption (VO2), six times a week, for 24 weeks, with alternate on-site supervision on odd days and remote monitoring on even days. On-site supervision will be carried out by a team coordinated by a Physical Education teacher and implemented at two times in the morning and another two in the afternoon with meeting points previously defined. At the end of each supervised walking session, 20 minutes of exercise will be performed using the equipment available at the Senior Citizens Academy set up in public squares in the region so that the total expenditure of calories spent weekly with physical activities reach about 2000 kilocalories.
15763806|NCT04746118|Other|INTEGRATIVE PRACTICES|The health integrative practices will includes Mind-Fullness, auriculotherapy and laying on of hands. A suitably qualified professional, using it use a practical manual so that the practice became uniform among the subjects, will apply the practice of Mind-Fullness in weekly 1-hour sessions to individuals. The practice of auriculotherapy will be applied to individuals by a professional qualified to perform the technique, which consists in the selection of auricular points according to the health problems presented and the therapeutic objectives that are to be achieved, followed by the insertion of the mustard seed at specific points in the ear over a six-month period. The laying on of hands will be carried out by properly trained individuals.
15763807|NCT04746105|Drug|TS-142|Subjects received single-dose of 10 mg of TS-142 (oral tablet)
15763808|NCT04746105|Drug|Dose-matched Placebo to TS-142|Subjects received single-dose matched placebo to TS-142 (oral tablet)
15763809|NCT04746079|Behavioral|Positive Imagery Therapy|Perform procedural sedation with slow push of ketamine, 1.5mg/kg, over thirty seconds while reading the Positive Imagery Therapy.
15763810|NCT04746053|Other|Pelvic ultrasound|Pelvic or vaginal ultrasound
15763819|NCT04745975|Drug|Personalized treatment guided by mini-PDX and RNA sequencing|Personalized treatment guided by mini-PDX and RNA sequencing
15763820|NCT04745975|Drug|Nab paclitaxel|Nab-paclitaxel 125 mg/m2，ivgtt，d1, 8, 15, q4w
15763821|NCT04745975|Drug|Eribulin|Eribulin 1.4 mg/m2, d1,8 q3w
15763822|NCT04745975|Drug|Vinorelbine|Vinorelbine 25mg/m2 d1,8, q3w
15763823|NCT04745975|Drug|Gemcitabine|Gemcitabine 1000 mg/m2, d1,8, q3w
15763824|NCT04745975|Drug|Capecitabine|Capecitabine 1250 mg/m2 bid po
15763825|NCT04745962|Device|Slimscope|Slimscope thin EBUS endoscope is inserted and used to visualize lung nodules.
15763826|NCT04745949|Drug|Brentuximab Vedotin|Given IV
15763827|NCT04745949|Drug|Cyclophosphamide|Given IV
15763828|NCT04745949|Drug|Doxorubicin|Given IV
15763829|NCT04745949|Biological|Nivolumab|Given IV
15763830|NCT04745949|Drug|Prednisone|Given PO
15763831|NCT04745949|Other|Quality-of-Life Assessment|Ancillary studies
15763832|NCT04745949|Biological|Rituximab|Given IV
15763833|NCT04745936|Other|Style curve similar to natural curvature of endotracheal tube|Stylet curvature is made similar to the natural curvature of endotracheal tube for intubation using C-MAC videolaryngoscope.
15763834|NCT04745936|Other|Style curve similar to hockey stick shape|Stylet curvature is made similar to hockey stick shape for intubation using C-MAC videolaryngoscope.
15763835|NCT04745910|Drug|Pegloticase|Given IV
15763836|NCT04745910|Drug|Rasburicase|Given IV
15763839|NCT04745884|Device|Non-invasive bilateral monitoring of ICP waveform|Brain4care non-invasive bilateral monitoring of ICP waveform
15763840|NCT04745871|Diagnostic Test|PSMA PET/CT|The PSMA PET/CT will be performed on an outpatient in the nuclear medicine department of the Brest University Hospital (CHRU). For this exam, the administration of 2-4 MBq/kg of 68Ga-HBED-CC-PSMA will be performed to patient by a single intravenous injection.
15763841|NCT04745858|Other|Bowen's Technique|In Bowen's Technique, sequence of short gentle moves are applied over Hamstrings. Skin slack is taken to the lateral side of muscle. The muscle is hooked by the thumbs from its lateral edge. Skin is carried along and thumb is flattened in a medial direction, the muscle plucks under the thumbs. Three alternate sessions per week are given for 4 weeks. The treatment time for each session is 20 minutes.
15763842|NCT04745858|Other|Muscle Energy Technique|Isometric contraction of hamstrings is performed by the patient being employing 20% of the strength. This contraction is resisted by the practitioner for 7-10 s. A three second relaxation period is given. This technique is repeated for three times. Three alternate sessions per week is given for 4 weeks.
15763843|NCT04745845|Procedure|Noradrenalin|Norepinephrine challenge (concentration 'A' ) in fluid responsive position
15763844|NCT04745845|Procedure|Noradrenalin|Norepinephrine challenge (concentration 'A') in non-fluid responsive position
15763845|NCT04745845|Procedure|Noradrenalin|Norepinephrine challenge (concentration 'B') in fluid responsive position
15763846|NCT04745845|Procedure|Noradrenalin|Norepinephrine challenge (concentration 'B') in non-fluid responsive position
15763847|NCT04745832|Drug|Zandelisib|Zandelisib 60 mg capsules taken daily for two cycles followed by intermittent schedule starting at Cycle 3
15763848|NCT04745832|Drug|Rituximab|Rituximab IV 375 mg/m2 for 6 cycles
15763849|NCT04745832|Drug|Bendamustine|Bendamustine IV 90 mg/m2 on Days 1 and 2 for 6 cycles
15763850|NCT04745832|Drug|CHOP|Cyclophosphamide, Vindcristine IV, and Prednisone daily orally
15763851|NCT04745819|Behavioral|1. The Child Behavior Checklist (CBCL), parent form|It consists of 113 items; the parents complete it to detect emotional and behavioural problems in children and adolescents aged 6 to 18 years. It is scored on a three-point Likert scale (0=absent, 1= occurs sometimes, 2=occurs often). The time duration for item responses is the past six months.
15763852|NCT04745806|Device|ActiGraft|Whole blood clot (WBC) gel
15763853|NCT04745793|Other|Hyperspectral and Fluobeam acquisition|"Once enough exposure of the operative site is achieved, an RGB (Red Green Blue) picture will be taken and the surgeon will depict the parathyroid glands on it, this picture will act as ground truth. At this point, without changing the surgical exposure, a second surgeon involved in the study will attempt once to detect the parathyroid glands intraoperatively using the HSI system and the Fluobeam® alternatively. The number and the position of the parathyroid glands visualized with each tool will be compared to the number and position of the glands previously visualized by the operating surgeon. The procedure will be repeated every time the surgeon attempts to visualize the parathyroid glands. The order of the detection tools randomized for each case will be preserved in case of repeated visualizations."
15763854|NCT04745780|Dietary Supplement|Myo-inositol, D-chiro-inositol, Gymnema sylvestre, Zinc and Alpha-lactalbumin|Myo-inositol (1950 mg), D-chiro-inositol (50 mg), Gymnema sylvestre (250 mg), Zinc (7,5 mg) and Alpha-lactalbumin (50 mg) - Two-times daily on an empty stomach, for 6 months
15763855|NCT04745780|Dietary Supplement|Placebo|Placebo - Two-times daily on an empty stomach, for 6 months
15763856|NCT04745767|Drug|TAK-994|T2 formulation.
15763857|NCT04745767|Drug|TAK-994|T1 formulation.
15763858|NCT04745767|Drug|TAK-994|T3 formulation.
15763859|NCT04745767|Drug|TAK-994|T4 formulation.
15763860|NCT04745767|Drug|TAK-994|T5 formulation.
15763861|NCT04745754|Other|Embedded primary care in cancer survivorship model|Primacy care physicians will receive comprehensive training in cancer survivorship care for low-risk, early stage breast and colorectal patients. Training will include continuing medical education (CME) modules, webinars, and in-person discussion and clinical shadowing.
15763862|NCT04745741|Radiation|IB-positive group|The gross tumor volume of the nasopharynx and neck nodes (GTVnx and GTVnd) were delineated according to the tumor extension. The CTVnx was defined as GTVnx + nasopharynx mucosa + 8mm +corresponding anatomical structure without the delineation of CTV1. The CTVnd was defined as GTVnd plus the elective neck area. The prescribe doses of GTVnx/GTVnd, CTVnx, CTVnd were 66-70Gy,54-56Gy and 50-54Gy in 31-35 fractions, respectively.
15763863|NCT04745728|Drug|Prednisone|1mg/kg/d p.o.which will be tapered after 2 months and discontinued over a 6-12 month period.
15763864|NCT04745728|Drug|Cyclophosphamide|1-2mg/kg/d p.o. with a target accumulated dose of 12g.
15763865|NCT04745728|Drug|Rituximab|1000mg I.V. on D1 and at 6 month. After 6 month, in patients with response but not complete remission, Rituximab could be stopped or repeated with a 6 month-interval (12 month, 18 month, 24 month) until complete remission. Rituximab 1000mg I.V. will be repeated on the 15th day of each Rituximab infusion if CD19+ B cell count>5/ul.
15763866|NCT04745715|Procedure|craniectomy|craniectomy outcomes and survival
15763867|NCT04745702|Combination Product|Low Calorie Meals Rich in Plant Components|Twice a day reduced calorie frozen ready meals (rich in plant components) to substitute participants' two main meals/day consecutively for a period of 16 weeks.
15763868|NCT04745702|Combination Product|Low Calorie Balanced Meals|Twice a day reduced calorie frozen ready meals (balanced composition) to substitute participants' two main meals/day consecutively for a period of 16 weeks.
15763869|NCT04745689|Drug|Durvalumab|"IV infusions through induction phase.
~IV infusions through maintenance phase until PD or other discontinuation criteria."
15763870|NCT04745689|Drug|AZD2811|IV infusions through maintenance phase until PD or other discontinuation criteria.
15763871|NCT04745689|Drug|Carboplatin|IV infusions through induction phase if chosen by Investigator.
15763872|NCT04745689|Drug|Cisplatin|IV infusions through induction phase if chosen by Investigator.
15763873|NCT04745689|Drug|Etoposide|IV infusions through induction phase.
15763874|NCT04745676|Behavioral|Telehealth|Telehealth ACP intervention advance care planning intervention
15763875|NCT04745663|Drug|Povidone-Iodine 0.3%|Low concentration iodine
15763876|NCT04745663|Drug|Povidone-Iodine 5%|Standard concentration iodine
15763877|NCT04745637|Drug|Ruxolitinib|provide access to ruxolitinib, for Patients with Primary Myelofibrosis (PMF) or Post Polycythemia Myelofibrosis (PPV MF) or Post-Essential Thrombocythemia Myelofibrosis (PET-MF)
15763878|NCT04745611|Diagnostic Test|MRI|3T cranial MRI with T1-, and T2 weighted imaging, a FLAIR sequence, diffusion-weighted imaging and susceptibility-weighted sequence
15763879|NCT04745611|Diagnostic Test|Neuropsychological assessment|Montreal Cognitive Assessment (MoCA), Rey-Auditory Verbal Learning Test (RAVLT), Trail making A/B, Stroop, Digit Span Coding, Judgement of line orientation (JOLO), Boston Naming Task (BNT), Controlled Oral Word Associations Task (COWAT), Category Fuency, Test of Memory Malingering (TOMM)
15763880|NCT04745611|Diagnostic Test|Questionnaires Patient|EuroQol-5D-5L (EQ-5D-5L), Utrecht Scale for Evaluation of Rehabilitation-Participation - Restrictions (USER-P-R), NeNeSCo-Q (questionnaire created for this study, including common neurological symptoms), Checklist for post-IC cognitive complaints (CLC-IC self-report), Hospital Anxiety and Depression Scale (HADS), Primary Care Post-Traumatic Stress Disorder (PC-PTSD-5), Utrecht Coping List (UCL) (subscale passive coping), PROMIS physical functioning short form, Items of Insomnia Severity Index (ISI) & Pittsburgh Sleep Quality Index (PSQI), Fatigue Severity Scale (FSS), Social Support List (SSL-12-I)
15763881|NCT04745611|Diagnostic Test|Questionnaires Family|EuroQol-5D-5L (EQ-5D-5L), Utrecht Scale for Evaluation of Rehabilitation-Participation - Restrictions (USER-P-R), Checklist for post-IC cognitive complaints (CLC-IC proxy-report), Hospital Anxiety and Depression Scale (HADS), Primary Care Post-Traumatic Stress Disorder (PC-PTSD-5), Utrecht Coping List (UCL) (subscale passive coping), Social Support List (SSL-12-I), Caregiver Strain Index (CSI)
15763882|NCT04745598|Behavioral|Control group: Dental Model|- Patients receive a demonstration of plaque control methods (modified Bass dental brushing technique and the use of the electric toothbrush) using a dental model.
15763883|NCT04745598|Behavioral|Computer-assisted teaching format group|- Patients receive a Powerpoint presentation containing:
15763884|NCT04745598|Behavioral|Plaque-disclosing group|- Patients place a few drops of a plaque-disclosing solution on the tongue and run the tongue over all the teeth and gums. With the aid of a hand mirror, patients can observe the stained plaque residue on their teeth
15763885|NCT04745598|Behavioral|Intra-oral camera group|- An ACTEON Soprocare® intraoral camera is used during the examination and explanation of oral hygiene strategies.
15763886|NCT04745572|Behavioral|High Carbohydrate Diet|Participants randomized to this group will participate in the State of Slim (SOS) weight management program and consume a high carbohydrate (HC) diet. Because this protocol uses a sequential, multiple assignment, randomized trial (SMART) design, response will be assessed at week 4. Responders will continue with their 1st stage assignment for the remainder of the study. Non-responders will be randomized to 2nd stage intervention of either combine HC diet with time-restricted eating (TRE) or HC diet with structured exercise counseling sessions (2 days per week).
15763887|NCT04745572|Behavioral|Reduced Carbohydrate Diet|Participants randomized to this group will participate in the State of Slim (SOS) weight management program and consume a reduced carbohydrate (RC) diet. Because this is a sequential, multiple assignment, randomized trial (SMART) design, response will be assessed at week 4. Responders will continue with their 1st stage assignment for the remainder of the study. Non-responders will be randomized to 2nd stage intervention of either combine RC diet with time-restricted eating (TRE) or RC diet with structured exercise counseling sessions (2 days per week).
15763888|NCT04745559|Biological|Pneumococcal conjugate vaccine (PCV13)|Licensed heptavalent pneumococcal conjugate vaccine (PCV13, Pneumococcal 13-valent conjugate vaccine
15763889|NCT04745559|Biological|CD19 targeted CAR T Cell Therapy|This is a personalized therapeutic approach that entails removal of T cells from patient's peripheral blood, genetic modification, activation and expansion in vitro to retarget cells against CD19 protein on the surface of B cells, and infusion of the genetically engineered cells back into the patient. CD19 is a surface protein that is expressed on B cells starting from early pre-B cells to mature fully differentiated B cells. Therefore, CD19-targeted CAR T cell therapy can effectively treat refractory B cell lymphomas.
15763890|NCT04745546|Device|WeFlow-JAAA Stent Graft System|The abdominal aorta stent graft system consists of the abdominal aorta embedded stent system, the abdominal aorta bifurcation stent system and the extended stent system. The abdominal aorta embedded stent has two embedded branch stents and two fenestrations. It can be combined with a peripheral small stent system of appropriate specifications to reconstruct the superior mesenteric artery, bilateral renal arteries and keep the abdominal trunk unobstructed. At the same time, the combination of the abdominal aorta embedded stent, the abdominal aorta bifurcation stent and the extended stent can solve the proximal renal and transrenal abdominal aortic aneurysm lesions with the upper edge of the abdominal aortic aneurysm body and the lower edge of the superior mesenteric artery opening ≥ 5 mm.
15764165|NCT04743180|Device|LUMINOR© Paclitaxel eluting balloon|Patients will be treated with the Luminor paclitaxel eluting balloon
15763891|NCT04745533|Diagnostic Test|Antigen detection test|To compare the results of the antigen detection test against the polymerase chain reaction in the study of contacts of COVID-19 patients during quarantine.
15763892|NCT04745520|Device|Rib fixation|"Rib fixation is performed by a senior surgeon. The patient is under general anesthesia. A thoracotomy focused on the fracture is performed to optimize access to the rib to be repaired. Video-assisted thoracic surgery (VATS) can be performed to better localize rib fractures. Significant muscle division is avoided. Removal of the periosteum is not required. The broken rib segments are approximated with forceps and the medical devices are used to fix the fracture. The medical devices are implemented according to the manufacturers' recommendations. The goal is to stabilize the chest wall. It is not useful to fix all fractures to stabilize the wall. A chest tube can be placed at the end of the operation.
~Medical devices
~The following medical devices can be used:
~MatrixRIB™, De Puy Synthes Companies, Zuchwill, Switzerland
~STRATOS™, MedXpert GmbH, Heitersheim, Germany
~NiTi Fixing PlatesTM, IAWAI, Yandzhou, China"
15763893|NCT04745520|Drug|Analgesia|Epidural analgesia is continuing for 24 to 72 hours post-randomization to maximize outcome benefits. Afterwards, paracetamol, NSAID and/or opioid treatment are used according to pain severity. In case of opioid use, morphine treatment is preferred. However, other opioid drugs or doses can be considered to better customize the treatment.
15763894|NCT04745507|Other|Inpatient Equivalent Home Treatment|At-home psychiatric treatment by means of a multiprofessional clinic team (an equivalent to stationary psychiatric care).
15763895|NCT04745494|Other|OT administration|OT nasal administration
15763896|NCT04745494|Other|Placebo administration|Placebo nasal administration
15763897|NCT04745481|Device|Trunk stabilization training device|"Conventional rehabilitation 30min daily, 20times 4weeks
~+Trunk stabilization training device 30min daily, 20time 4weeks"
15763898|NCT04745481|Device|Conventional rehabilitation|"Conventional rehabilitation 30min daily, 20times 4weeks
~+Conventional rehabilitation 30min daily, 20times 4weeks"
15763899|NCT04745468|Device|CRP apheresis|Selective CRP apheresis by use of the PentraSorb-CRP adsorber
15763900|NCT04745455|Other|Infant formula containing prebiotics, probiotics and postbiotics|Infant formula containing prebiotics, probiotics and postbiotics
15763901|NCT04745442|Drug|Antithrombin + best available treatment|The subject will be treated with Antithrombin (50 IU/Kg/12h) for 72 hours and the best available treatment for COVID-19.
15763902|NCT04745442|Drug|Best available treatment|The subject will be treated with the best available treatment for COVID-19.
15763903|NCT04745429|Other|breathing exercises, cold exposure and meditation|It is a combination of exercises that include breathing exercises, cold exposure and meditation
15763904|NCT04745403|Drug|mRNA HBV/TCR T-cells|"Study Infusion
~The first dose of mRNA HBV-TCR T-cells at dose 1x10e5/kg BW will be infused on Day 0, and subsequently incremental doses on Day 14 and 28, up to the dose of 5-10x10e6/kg BW."
15763905|NCT04745390|Radiation|Radiation therapy|Patients will be randomized between standard of care palliative irradiation of 2000cGy in 5 fractions (Arm 1) versus radiobiologically guided dose selection also in 5 fractions (Arm 2). For all patients randomized, radiation is to be delivered in 5 fractions delivered over 5 to 15 days.
15763906|NCT04745377|Diagnostic Test|IgG neutralising antibody titers to S1 and S2 proteins of SARS-COV-2 virus|IgG neutralising antibody titers to S1 and S2 proteins of SARS-COV-2 virus
15763907|NCT04745364|Behavioral|A 4-week Bharatanatyam course from the organization Mindful Kala|The 4-week Mindful Kala program focuses on three components of Bharatanatyam: nritta (i.e. technical movements), natya (i.e. storytelling), and nritya (i.e. a combination of movements and narration; nritta + natya).
15763911|NCT04745338|Device|3max cool shaping device|cryolipolysis sessions are applied on abdomen area each session for 40 min. each
15763912|NCT04745338|Dietary Supplement|low calolric diet|low caloric diet (1200cal/day)
15763913|NCT04745325|Behavioral|SMAART Canada smartphone app|a smartphone app designed to promote reductions in alcohol consumption among people who drink in a hazardous fashion
15763914|NCT04745312|Device|Visible light|Ambient room lighting will be supplemented with additional light from a task lamp.
15763915|NCT04745299|Biological|Lenzumestrocel|Single cycle administration group : injections twice in a 26-day interval Multiple administration group : injections twice in a 26-day interval followed by repeated three times injections every three months
15763916|NCT04745299|Drug|Riluzole|concomitant administration of Riluzole to all groups, except subjects to whom Riluzole administration is deemed impossible owing to adverse events as determined by medical experts
15763917|NCT04745299|Drug|Placebo Comparator|"Single cycle administration group: Placebo comparator is injected three times every three months after injection of Lenzumestrocel twice in a 26-day interval.
~Control group: Placebo comparator is injected twice in a 26-day interval followed by repeated three times injcections every three months"
15763918|NCT04745286|Drug|S-ketamine|Patients will receive the label-covered trial agent covered by the label after premedication 5 min before induction. Agent preparation method of S-ketamine group (Group S): Draw the dosage of S-ketamine 0.25mg ·kg -1 and dilute it with normal saline to 5ml in opaque 5-ml syringes.
15763919|NCT04745286|Drug|normal saline group|"Patients will receive the label-covered trial agent covered by the label after premedication 5 min before induction. Normal saline group (Group N): 5ml of normal saline, labeled as study agents."
15763920|NCT04745273|Drug|Ondansetron 4 MG (Kemoset 4mg)|Ondansetron 4mg (iv) will administer to participants
15763921|NCT04745273|Other|Salin solution|Salin solution 2ml (iv) will administer to participants
15763922|NCT04745260|Drug|Intranasal Fentanyl Spray and Intranasal Midazolam Spray|Intranasal Fentanyl 2mcg/kg and Intranasal Midazolam 0.2mg/kg
15763923|NCT04745260|Drug|Intranasal Midazolam Spray|Intranasal Midazolam 0.3mg/kg
15763924|NCT04745247|Procedure|RSS|"Repetitive somatosensory stimulation (RSS) applied on a small region of the face for 3 hours
~Sham Repetitive somatosensory stimulation (RSS) applied on a small region of the face for 3 hours : the number of stimuli is reduced compared to the effective RSS"
15764166|NCT04743167|Procedure|Surgery|Laparoscopic treatment of endometriotic lesions
15764167|NCT04743167|Procedure|IVF|Up to three completed cycles of IVF
15763925|NCT04745234|Drug|Mogamulizumab|"For the first 28-day induction cycle (C1), mogamulizumab 1 mg/kg will be administered as an IV infusion through a 0.22- or 0.2-μm in-line filter over at least 60 minutes on Days 1, 8, 15, and 22.
~For all subsequent 28-day cycles (C2, 3, 4, etc.), mogamulizumab 2 mg/kg will be administered as an IV infusion over at least 60 minutes on Day 1 of each subsequent therapy cycle."
15763926|NCT04745221|Other|autologous fecal bacteria|autologous fecal bacteria transplantation
15763927|NCT04745208|Behavioral|Simulation based education|high fidelity simulation with moulage
15763928|NCT04745182|Behavioral|MASTERY|A 12-week, phone-delivered intervention utilizing positive psychology (PP), motivational interviewing (MI), and specific midlife modules (e.g., on time management, financial stress, caregiving stress, or occupational stress) to promote physical activity and well-being in mid-life adults.
15763930|NCT04745156|Device|RNS System Implantation|Following resection consistent with SoC, if there is evidence of residual tumor which cannot be resected due to invasion of hand-M1 but which is small enough to be covered by two four-electrode strips, these strips will be placed on the functional cortex of interest and secured to the dura. The location of the leads will be registered into the navigation software (either Medtronic Stealth or Brainlab). The dura will then be closed as watertight as possible, and the RNS System will be incorporated into the craniotomy on closure Prior to closure, four bone screws will be placed and registered to the intraoperative navigation system as internal fiducials to be retrieved for future procedures.
15763931|NCT04745143|Drug|NMDAE|Use of an NMDA enhancer for the treatment of schizophrenia
15763932|NCT04745143|Drug|Placebo Cap|Use of placebo as a comparator
15763933|NCT04745130|Drug|Sintilimab，regofinib，cetuximab|KRAS BRAF mutant Sintilimab 200mg D1 Q3W + regafinil 80mg D1-21 Q4W；KRAS BRAF wild type Sintilimab 200mg d1q3w+ regofinib 80mg d1-21 q4w with or without cetuximab 500mg/m2 q2w
15763934|NCT04745117|Behavioral|READHY - questionnaire|The READHY tool consists of 70 questions divided into three sections, one with a focus on eHealth literacy, one on self-management and one on the social context. The READHY consists of the eHealth Literacy Questionnaire (eHLQ) that includes seven scales, supplemented with four scales from the Health Education Impact Questionnaire (heiQ) and two scales from the Health Literacy Questionnaire (HLQ). The READHY tool has been validated. Each question presented to the participant as a statement and scored on a 4-point rating, from 1=strongly disagree to 4=strongly agree. The overall score of each scale was calculated as the mean score of the 4-6 items (i.e., statements) that constitute the scale (2).
15763935|NCT04745104|Drug|SHR-1707|SHR-1707 will be administered through IV infusion
15763936|NCT04745104|Drug|Placebo|Placebo will be administered through IV infusion
15763937|NCT04745091|Procedure|total mesorectal excision|excision of the rectum with complete excision of the mesorectum
15763938|NCT04745078|Other|Caboxy30|carboxy30 to periorbital dark halos
15763939|NCT04745078|Other|Caboxy60|carboxy60 to periorbital dark halos
15763940|NCT04745065|Behavioral|Connect2BWell|Please see the description provided for arm 1.
15763941|NCT04745052|Other|Clinical observation index|The first is to verify the application effect of intravenous thrombolytic hemorrhage prediction models (HAT, SIT-sICH, THRIVE) in the population of acute ischemic stroke in Guangdong Province, and verify the clinical application effects of existing prediction models. Secondly, analyze the predictive value of clinical indicators, optimize HAT, SIT-sICH, and THRIVE scores, construct an improved HT prediction model, and optimize and improve the existing prediction model. The third is to apply the improved HT prediction model to the clinic, collect clinical data prospectively, evaluate the prediction effect of the model, and evaluate the clinical application effect of the improved prediction model.
15763942|NCT04745039|Device|Endopatch System|The patch system for aortic dissection tear is composed of a dissection tear patch system and an adjustable bend conveyor. The patch system is composed of a patch and a conveying steel cable. The patch is pre-installed on the conveying steel cable.
15763945|NCT04745013|Behavioral|PRIORITY|PeRsonalIzed remOtely guided preventive exeRcIse therapy for a healThY heart
15763946|NCT04745013|Behavioral|Usual care|Only a written personalized exercise prescription will be provided.
15763947|NCT04744974|Behavioral|Diet intervention|Participants will be given dietician counseling on their assigned diet
15763948|NCT04744961|Other|SCAR-Q survey|Telephone survey
15763949|NCT04744948|Device|Treadmill exercise|high intensity interval training
15763950|NCT04744948|Other|low caloric diet|low caloric diet (1200ca/lday)
15763951|NCT04744935|Device|1064 nm long-pulse Nd:YAG laser|BCC lesion will be treated with long-pulse 1064 laser, with surface temperature monitored by infrared camera.
15763952|NCT04744922|Dietary Supplement|Extracts of citrus peels standardized in AUR and NAR (phytocomplex).|One capsule a day for 9 months
15763953|NCT04744909|Device|SafeTrach for tracheotomy|The navigation system is a forceps-like instrument with an outer and an inner shank. The inner shank serves as a ventilation lumen and stabilizes the orotracheal tube in the midline of trachea. The outer shank acts as a three-dimensional guide for the puncturing needle to the midline of trachea
15763954|NCT04744896|Device|cryolipolysis(3 max cool shaping)|cryolioplysis applied over abdomen area
15763955|NCT04744896|Device|Treadmill (jkexer focus 8020A)|aerobic training ( high intensity interval training)
15763975|NCT04744675|Drug|Triamcinolone Acetonide 40mg/mL|Triamcinolone acetonide is a synthetic glucocorticoid corticosteroid with marked anti-inflammatory action, in a sterile aqueous suspension suitable for intramuscular, intra-articular, and intrabursal injection.
15833873|NCT04173611|Drug|EXPAREL|Injection into the Intrathecal space.
15763956|NCT04744883|Other|Spinal Manipulation Therapy (SMT)|2 SMT techniques are administered each session, both of which are scripted interactions between the physical therapist (PT) providing the SMT and the subjects: 1) Participants will lie on the SMT table for 20 mins, while the PT sits approximately 6 ft away. As part of the script, the PT will review with subjects the inclusion/exclusion criteria ostensibly to ensure that nothing has changed. 2) The PT will perform the 2 SMT techniques during the next 20 mins. 3) Subjects will sit upright in a chair for the remaining 20 mins, while the PT sits approximately 6 feet away. The PT will review home exercises with participant.
15763957|NCT04744883|Drug|Naloxone|In randomized order (crossover) across 2 laboratory sessions each approximately 3 days apart, participants will receive either 1) 2 doses of saline placebo (20ml each) or 2) weight-adjusted doses of Naloxone beginning with a dose of 0.11mg/kg followed by a weight-adjusted dose of 0.055 mg/kg
15763958|NCT04744883|Drug|Placebo|In randomized order (crossover) across 2 laboratory sessions each approximately 3 days apart, participants will receive either 1) 2 doses of saline placebo (20ml each) or 2) weight-adjusted doses of Naloxone beginning with a dose of 0.11mg/kg followed by a weight-adjusted dose of 0.055 mg/kg
15763959|NCT04744883|Behavioral|Mindfulness Based Stress Reduction Therapy (MT)|Each MT session consists of (a) body scan meditation accompanied by awareness of breathing and other bodily sensations while in a lying position, (b) sitting meditation, focusing on awareness of breathing, bodily sensations, thoughts, and emotions (c) gentle movement exercises intended to develop awareness (mindfulness) during movement. In-session activities include suggestions for application of mindfulness as a method for responding positively to stress; dealing with the challenges of pain; and exercises focusing on the challenges and achievements patients experience in integrating mindfulness into their lives and the stressful situations they encounter. Additional discussion will focus on stress reactivity and they will be taught problem-solving skills to develop solutions to meet MT goals. Finally, patients will develop a written maintenance plan that includes a list of short- and long-term goals for applying mindfulness methods and a plan for dealing with possible setbacks.
15763960|NCT04744857|Combination Product|The experimental apparatus consisted of artificial aortic valve, transporter and grip-loading system.|Using the grip-loading system, the artificial aortic valve was squeezed and loaded into the sheath of the transporter through the vascular approach.The artificial aortic valve is delivered and positioned at the correct anatomical position for release. For example, the artificial main valve is displayed after partial release If the aortic valve is not in the correct anatomical position, the artificial aortic valve can be recovered and placed into the sheath tube of the transporter for re-positioning and release.
15763961|NCT04744844|Procedure|blastocoel fluid biopsy|In the present study, blastocoel fluid biopsy (BF-biopsy) and collapse will be performed using a microinjection pipette similar to that used to perform ICSI. The pipette will be pushed gently through the zona pellucida and TE, and up to 90% of the BF will be aspirated.
15763962|NCT04744831|Drug|DS-8201a 5.4 mg/kg Q3W|DS-8201a for injection will be administered intravenously (IV) at a dose of 5.4 mg/kg every 3 weeks (Q3W)
15763963|NCT04744831|Drug|DS-8201a 6.4 mg/kg Q3W|DS-8201a for injection will be administered intravenously (IV) at a dose of 6.4 mg/kg every 3 weeks (Q3W)
15763964|NCT04744818|Dietary Supplement|Iron syrup|Daily supplementation with iron
15763965|NCT04744818|Dietary Supplement|Multivitamin syrup|Daily supplementation with multivitamins
15763966|NCT04744805|Other|face mask or not|long term face mask wear
15763967|NCT04744792|Other|Short Form - 36|"Medical outcomes: 36-item short form health survey (SF-36)
~The SF-36 was used as a measure of health-related QoL because it is an internationally recognized global measure. It comprises 36 items that measure perceived health on eight scales (i.e., physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health) with higher scores (range 0-100) reflecting better perceived health. Additionally, two summary scores can be obtained: the physical component summary score (PCS) and the mental component summary score (MCS).
~In addition, this tool has been validated in Turkish patients"
15763968|NCT04744792|Other|WHODAS-II|"The World Health Organization disability assessment schedule II (WHODAS-II)
~The WHODAS-II is an instrument developed by the World Health Organization to assess behavioral limitations and restrictions regarding participation in specific activity domains experienced by an individual independent of their medical diagnosis. The conceptual frame of reference of this instrument is the International Classification of Functioning, Disability, and Health (ICF). Specifically, the instrument is a 36-item, generic, multidimensional questionnaire designed to evaluate the functioning of the individual in six activity domains (i.e., understanding and communicating, getting around, self-care, getting along with people, life activities, and participation in society). This questionnaire has been validated in Turkish patients."
15763969|NCT04744779|Behavioral|Office-based accommodative/vergence therapy and home reinforcement|Office-based accommodative/vergence therapy (60 minutes per visit, one time per week, 16 weeks) and home reinforcement (15 minutes each time, five times per week, 16 weeks)
15763970|NCT04744766|Procedure|major duct excision|2 methods of major/central mammary duct excision are compared as regard the outcome
15763971|NCT04744753|Drug|Calcium Ionophore A23187|"Calcium Ionophore A23187 is used in laboratories to increase intracellular Ca2+ levels in intact cells. It also uncouples oxidative phosphorylation, the process cells use to synthesize Adenosine triphosphate which they use for energy. In addition, A23187 inhibits mitochondrial ATPase activity. A23187 also induces apoptosis in some cells (e.g. mouse lymphoma cell line, or S49, and Jurkat cells) and prevents it in others (e.g. cells dependent on interleukin 3 that have had the factor withdrawn).
~In IVF field, Ca Ionophore can be used in case of low fertilization rate after ICSI procedure, particularly with Globozoospermia (Round Head sperm syndrome), Ca Ionophore will replace absence of sperm acrosom, and plays role in oocyte activation after ICSI. Recommended use is 0.5 microgram/ml twice for 10 min interrupted with fresh media with 30 min incubation, followed with regular injected eggs culture for IVF."
15763972|NCT04744740|Device|in-home sleep recording|in-home, nightly, zero-burden objective quantification of sleep scheduling and sleep heart rate via a mattress-top sensor (Sleepace RestOn) + ad lib quantification of blood SaO2 via a ring-based sensor (Bodimetrics Circul) + ad lib quantification of sleep and waking activity and heart rate via a wrist-worn sensor (Garmin Vivosmart 4)
15763973|NCT04744727|Drug|paracetamol-pethidine|100 ml containing 1000 mg paracetamol -50 mg pethidine HCL
15763974|NCT04744701|Diagnostic Test|Hemochron Signature Elite Whole Blood Microcoagulation System|Bedside test of Activated Partial Thromboplastin Time
15834200|NCT04171037|Other|Questionnaire Administration|Ancillary studies
15763976|NCT04744675|Drug|Saline Injection|Saline is a buffer solution commonly used in biological research. It is a water-based salt solution containing disodium hydrogen phosphate, sodium chloride and, in some formulations, potassium chloride and potassium dihydrogen phosphate. The buffer helps to maintain a constant pH. The osmolarity and ion concentrations of the solutions match those of the human body.
15763977|NCT04744662|Drug|ONL1204 Ophthalmic solution|Liquid formulation administered by intravitreal (IVT) injection
15763978|NCT04744662|Procedure|sham injection|sham injection is done by touching the eye surface with a syringe without a needle
15763979|NCT04744649|Drug|XELOX or SOX|"XELOX: Oxaliplatin+Capecitabine; SOX: Oxaliplatin+S-1
~Oxaliplatin: 130mg/m2, iv drip for 2h, d1, q3w;
~S-1:40~60mg Bid, d1~14, q3w;
~Capecitabine: 1000mg/m2 Bid, d1-14, q3w;
~Neoadjuvant chemotherapy for 4 cycles, adjuvant chemotherapy for 4 cycles.
~Drug: Oxaliplatin Oxaliplatin: 130mg/m2，iv drip for 2h，d1, q3w
~Drug: S1 S-1: 40~60mg Bid，d1~14, q3w
~Drug: Capecitabine Capecitabine: 1000mg/m2 Bid, d1-14, q3w Other Name: XELODA
~JS001: 240mg, ivdrip, d1, q3w;
~S-1:40~60mg Bid, d1~14, q3w;
~Capecitabine: 1000mg/m2 Bid, d1-14, q3w;
~Neoadjuvant chemotherapy for 4 cycles, adjuvant chemotherapy for 4 cycles.
~Drug: JS001 JS001, recombinant humanized anti-PD-1 monoclonal antibody for injection; 240mg ivdrip, d1, q3w.
~Other Name: PD-1 antibody
~Drug: Oxaliplatin Oxaliplatin: 130mg/m2,iv drip for 2h, d1, q3w
~Drug: S1 S-1: 40~60mg Bid,d1~14, q3w
~Drug: Capecitabine Capecitabine: 1000mg/m2 Bid, d1-14, q3w Other Name: XELODA"
15763980|NCT04744649|Drug|S001+XELOX or SOX|"XELOX: Oxaliplatin+Capecitabine; SOX: Oxaliplatin+S-1
~JS001: 240mg, ivdrip, d1, q3w;
~S-1:40~60mg Bid, d1~14, q3w;
~Capecitabine: 1000mg/m2 Bid, d1-14, q3w;
~Neoadjuvant chemotherapy for 4 cycles, adjuvant chemotherapy for 4 cycles.
~Drug: JS001 JS001, recombinant humanized anti-PD-1 monoclonal antibody for injection; 240mg ivdrip, d1, q3w.
~Other Name: PD-1 antibody
~Drug: Oxaliplatin Oxaliplatin: 130mg/m2,iv drip for 2h, d1, q3w
~Drug: S1 S-1: 40~60mg Bid,d1~14, q3w
~Drug: Capecitabine Capecitabine: 1000mg/m2 Bid, d1-14, q3w Other Name: XELODA"
15763981|NCT04744636|Drug|Other|"Healthy volunteers will be selected within 3 weeks before inclusion (Day 0). The investigations will be performed on 2 days (Day 1 (D1) and Day 2 (D2)): vascular endothelial function assessment and blood collection for biomarker investigation on Day 1 and Case Report Form (CFR) on Day 2.
~Then, subjects will be discharged at the end of the last investigation day (Day 2).
~All the participants have received two pharmacological agents (NIMP) :
~Acetylcholine : administered subcutaneously (by iontophoresis) to assess maximal vascular endothelial function.
~Adenosine : administered intravenously during MRI for the measurement of CFR."
15763982|NCT04744636|Drug|Other|"Type 2 diabetic patients will be selected within 3 weeks before inclusion (Day 0).
~The investigations will be performed on 2 days (Day 1 (D1) and Day 2 (D2)): vascular endothelial function assessment and blood collection for biomarker investigation on Day 1 and CFR on Day 2.
~Then, subjects will be discharged at the end of the last investigation day (Day 2).
~All the participants have received two pharmacological agents (NIMP):
~Acetylcholine : administered subcutaneously (by iontophoresis) to assess maximal vascular endothelial function.
~Adenosine : administered intravenously during MRI for the measurement of CFR."
15763983|NCT04744623|Drug|large dose of prednisolone plus intra-lesional of Triamcinolone Acetonide followed the systemic combination of mycophenolate mofetil (MMF), dapsone and low dose prednisolone in treatment of MMP|10 patients suffering from MMP were selected after complete diagnosis based on their clinical diagnosis and immunopathologic findings of IgG, IgA, and/or C3 targeting skin basement membranes with a linear deposition pattern refered from dermatology department. These patient were treated using large dose of prednisone 60mg daily plus intrational injection of Triamcinolone Acetonide every week until no further improvement of the lesion occurred (stage I) then the prednisolone is withdrawn gradually and substituted with using 1 g of MMF plus 50 mg dapsone till the lowest dose of prednisone could be reached (stage II).
15763984|NCT04744610|Diagnostic Test|Add 4-hour delayed radiographs|Normal patients only need to take delayed radiographs 24h after HSG operation. In this study, 4-hour delayed radiographs were added to the 24-hour delayed radiographs, so that the patients had to take one more delayed radiographs .
15763985|NCT04744597|Behavioral|Real execution of Fitts's law tasks|Children will be training Fitts's law tasks of different difficulties. Once each task will be solved, they will receive a new, more demanding task
15763986|NCT04744597|Behavioral|Motor imagery of Fitts's law tasks|Children will be training Fitts's law tasks of different difficulties, same as RE group but the exception of doing it mentally - motor imagery of Fitts's law tasks with eyes open.
15763987|NCT04744597|Behavioral|Skip counting|Children in SCg will silently count (one number per second) in the same working blocks as both experimental groups with a task of saying the number they reached during each block - control condition to keep them mentally active at very low mental engagement.
15763988|NCT04744584|Other|Medication reconciliation|MR will be performed directly upon entering the patient's hospital for a first PAH or HTP-Thrombo embolic assessment, just after inclusion. Information regarding the treatments taken by the patient at the time of admission will be retrieved. The entry medication assessment will then be compared with the first medical prescription in order to identify whether medications have been forgotten, prescribed at a different dosage or prescribed when not indicated, etc. All of these differences will be considered medication errors if the reason for the discrepancy is not entered in the patient medical file.
15763989|NCT04744584|Other|Medication reconciliation|After inclusion of the patient, the MR will be carried out retrospectively, that is to say that the information concerning the treatments taken by the patient at the time of the first assessment will be retrieved during the period of the first reassessment (therefore with a delay of 3 to 6 months depending on the deadline for the first assessment). All these discrepancies will be considered medication errors if the reason for the discrepancy was not entered in the patient's computerized medical record (IMR).
15763990|NCT04744571|Drug|aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor|Optimal medical therapy includes dual antiplatelet therapy and statins (aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc). And optimal medical therapy should include adequate ventricular rate- limiting medication (i.e. Beta- blocker or rate-limiting calcium antagonist) where appropriate. Anti- anginal therapy should be used if the patients have symptom.
15763991|NCT04744571|Device|coronary wires. or coronary balloons|all species of coronary wires, or plain balloons
15763992|NCT04744571|Other|drug-coated balloon|Drug-coated balloon including all sizes and all brands
15763993|NCT04744571|Device|drug-eluting stent|Drug-eluting stent including all sizes and all brands
15765288|NCT04734197|Drug|Restasis 0.05% Ophthalmic Emulsion|topical ophthalmic emulsion
15763994|NCT04744558|Other|Low carb high fat ketogenic dieting|Macronutrient ratios for low carb high fat ketogenic diet were 20 %, 5 %, 75 % of protein, carbohydrates and fat, respectively. Caloric intake for experimental phase was set to cover basal metabolism and sedentary activities (BMR times 1.2) for every participant using the Mifflin St Jeor equation.
15763995|NCT04744558|Other|Low carb high fat non-ketogenic dieting|Macronutrient ratios for low carb high fat non-ketogenic diet were 20 %, 15 %, 65 % of protein, carbohydrates and fat, respectively. Caloric intake for experimental phase was set to cover basal metabolism and sedentary activities (BMR times 1.2) for every participant using the Mifflin St Jeor equation.
15763996|NCT04744545|Behavioral|Meru Health Program|12 week evidence-based mental health intervention overseen by a licensed clinical therapist delivered via Smartphone app
15763997|NCT04744545|Dietary Supplement|Curcumin|1500mg/day curcumin plus black pepper to aid absorption
15763998|NCT04744532|Drug|Bosutinib|Subjects will receive 100 mg, 200mg, 300mg or 400 mg of bosutinib once daily, orally.
15763999|NCT04744519|Other|Collect data|- Controlled ovarian stimulation with GnRH antagonists effected to the patients in order to get their eggs through follicular puncture, which will be trigger by GnRH analogue. The eggs will be isolated and processed according to the standard protocol.
15764000|NCT04744506|Device|Tissue Marker Clip|Tissue Marker Clip Placed in Metastatic Lymph Node (Before Neoadjuvant Chemotherapy for Breast Cancer)
15764001|NCT04744493|Device|ExaBlate 4000|The Exablate 4000, an advanced, non-invasive technique for performing ablation of the Thalamus for treating Essential Tremor, received FDA PMA (P150038) approval for unilateral treatment of Essential Tremor in 2016.
15764002|NCT04744480|Procedure|The combined topical anesthesia induction group|The superior glottic mucosa would be anesthetized 3 times with a vaporizer before intravenous anesthesia. After the intravenous induction, a catheter would be inserted to provide the subglottic anesthesia，3-5ml 2% lidocaine would be used for supraglottic anesthesia, and 3ml 1% tetracaine would be used for subglottic anesthesia.
15764003|NCT04744467|Device|IOL implantation experimental|Mono- or bilateral implantation of toric intraocular lenses PODEYE TORIC. If only one eye qualifies for toric lens implantation due to small amount of pre-existing corneal astigmatism, one eye will be implanted with PODEYE TORIC and the contralateral eye will be receive an implantation with the monofocal parent lens PODEYE (PhysIOL sa/nv, Liège, Belgium).
15764005|NCT04744441|Procedure|CHOLECYSTECTOMY|Surgical treatment
15764006|NCT04744441|Procedure|PERCUTANEOUS CHOLECYSTOSTOMY|Patients treated with a percutaneous cholecystostomy
15764007|NCT04744441|Procedure|EXCLUSIVE ANTIBIOTICS|Patients that are treated only with i.v. antibiotics
15764008|NCT04744428|Behavioral|Autism Parent Navigators|The Autism Parent Navigator program consists of six sessions delivered to parents in the home, supporting adjustment to ASD, accessing services, and coparenting support.
15764009|NCT04744428|Behavioral|Peer mentoring|Six in-home or telephone sessions, depending on family uptake, providing non-manualized general support as usual from parent peer mentors regarding adjustment to ASD.
15764010|NCT04744415|Other|Epidemiology of admissions|Cardiology Intensive Care Unit admission
15764011|NCT04744402|Drug|Autologous Chondrocyte Implantation (CartiLife®)|CartiLife consists of small beads (1 mm in diameter) in suspension, developed from pellet culture of autologous costal chondrocytes after multiplication. The beads are implanted in an injective manner with fibrin glue through minimal arthrotomy. The dose depends on the size (volume) of the defect, recommended dose is 480 pellets/cm^3 defect
15764012|NCT04744402|Procedure|Microfracture Surgery|Microfracture surgery, performed by arthroscopy after the joint is cleaned of calcified cartilage, will be conducted using an awl or drill to create tiny fractures in the subchondral bone plate.
15764013|NCT04744389|Device|Hypothermic Machine Perfusion|The perfusion system was primed with 4 L of Belzer machine perfusion solution University of Wisconsin Machine Perfusion Solution (Bridge for Life, Ltd., Columbia, SC). The arterial and portal pressures were set at 25 mm Hg with a flow and at 3-4 mm Hg with a continuous flow, respectively. The oxygen flow was set at 0.25 L/minute. The target liver temperature was between 4°C and 10°C.
15764014|NCT04744389|Device|Normothermic Machine Perfusion|Grafts were perfused at 37°C in an OR next to the transplant OR and under medical supervision using a blood-based perfusate. Initial perfusate temperature was set at 20°C and raised by 1°C every 2 minutes. Oxygenation was provided by an anesthesia ventilator initially set at 4 L/minute with 30% fraction of inspired oxygen, and later adjusted based on perfusate pH, partial pressure of oxygen, and partial pressure of carbon dioxide. Blood gas analyses were drawn every 20 minutes during the first hour and every 30 minutes thereafter with the aim to maintain a physiological pH and ionogram result, and a partial pressure of oxygen between 200 and 250 mm Hg. Perfusate glucose, transaminases, and lactate were measured during NMP as were bile production and quality (pH, sodium, glycemia, lactate, and HCO3)
15764015|NCT04744376|Other|QoR15|Quality of Recovery 15 questionnaire (QoR-15) is a measurement tool that evaluates the recovery quality of patients after surgery and anesthesia by the patient himself.
15764016|NCT04744376|Other|ACS risk calculator|American College of Surgeons risk calculator is a risk prediction tool for abdominal surgery. It calculates the risk of possible postoperative complications according to the type of surgery, ASA score, and patients' preoperative co-morbidities.
15764017|NCT04744376|Other|Clavien - Dindo classification|It is a classification for postoperative complications.
15764018|NCT04744363|Drug|Stelara PFS|Pre filled syringes filled with AVT04 and Stelara
15764019|NCT04744350|Procedure|Treatment of FFP type IIb and IIc|Patients will either be randomized in the surgical or conservative group.
15764020|NCT04744337|Procedure|orthodontic treatment|fixed orthodontic treatment in adolescent females initially treated with removable functional appliances for skeletal class II, Angle's class II division 2 malocclusion.
15764021|NCT04744324|Behavioral|Self-supporting Care|Individualized self-supporting care with four principals (i.e., drinking water, exercise, excretion, and nutrition)
15764022|NCT04744324|Behavioral|Home health education|Individualized home health education
15764078|NCT04743856|Behavioral|ActiveGOALSv2|13 weekly self-guided sessions on problem solving and goal setting related to increasing physical activity, and weekly remote coaching support. Once a month support materials sent monthly from months 4-12 of intervention.
15834201|NCT04171037|Device|Optiflow THRIVE|Oxygen Administration
15764023|NCT04744311|Other|ObsQoR-11T Questionnaire|The ObsQoR-11T questionnaire consists of 11 items assessing different aspects of postpartum recovery: physical comfort and pain, physical independence and emotional status. If the patient is not able to read the questionnaire herself, a third person can ask the questions orally to the patient. Each item is scored from 0 to 10 and the total score is the sum of the score for each item, which is a score from 0 to 110.
15764024|NCT04744298|Other|TheraPPP|"TheraPPP Steps:
~Step 1. All mechanically ventilated patients will have a height measured and documented. Step 2. Screening for HRF. Step 3. Initiate Lung Protective Ventilation (LPV). Step 4. Paralysis. Step 5. Prone Positioning."
15764025|NCT04744285|Other|Cigarette packaging|receive normal packet cigarette
15764026|NCT04744285|Other|Data capture|Attend video sessions
15764027|NCT04744285|Other|Questionnaire administration|Ancillary studies
15764028|NCT04744272|Device|myAsthma|myAsthma is an online digital self-management application to support asthma patients by offering education, inhaler technique, pulmonary rehabilitation, symptoms and medication usage tracking remotely.
15764029|NCT04744259|Behavioral|Behavioural Activation|A psychological intervention which aims to increase activity and reduce depressive symptoms.
15764030|NCT04744246|Other|load carriage|35 pound load carried on the back
15764031|NCT04744233|Other|Orange juice|Subjects were enrolled to consume 500 mL of orange juice/day during three consecutive 14 days periods separated by 1 - 1.5 month washouts. The orange juices assayed were: freshly squeezed (FS), commercially available low pasteurized juice (LP) and juices treated by high-pressure processing (HPP) and by pulsed electric fields (PEF). All participants consumed the LP and the HPP orange juices. Six subjects consumed PEF-orange juice and other six consumed the FS-orange juice.
15764032|NCT04744220|Other|Yoga Training Program (exercises)|Training: Before the yoga program, the patients will be informed about the bronchiectasis disease and its symptoms, as well as all the parameters used in the evaluation, tests and the content of the yoga session. The patients will start with breathing exercises, then relaxation exercises, warm-up exercises, asanas (posture exercises) and finally the yoga training program will be completed with deep relaxation technique.
15764033|NCT04744207|Drug|GS-248|120 mg, capsule, once daily for 4 weeks
15764034|NCT04744207|Drug|Placebo|capsule, once daily for 4 weeks
15764035|NCT04744194|Other|Nordic hamstring exercise program|Week 1 - 1 session per week consisting of 2 sets of 5 reps of the exercise Week 2 - 2 sessions per week consisting of 2 sets of 6 reps of the exercise Week 3 - 3 sessions per week consisting of 3 sets of 6 reps of the exercise Week 4 - 3 sessions per week consisting of 3 sets of 8 reps of the exercise Weeks 5 and 6 - 3 sessions per week consisting of 3 sets of the exercise. Set 1 with 12 reps, set 2 with 10 reps and set 3 with 8 reps.
15764036|NCT04744194|Other|Single leg bridge exercise program|Week 1 - 1 session per week consisting of 2 sets of 5 reps of the exercise Week 2 - 2 sessions per week consisting of 2 sets of 6 reps of the exercise Week 3 - 3 sessions per week consisting of 3 sets of 6 reps of the exercise Week 4 - 3 sessions per week consisting of 3 sets of 8 reps of the exercise Weeks 5 and 6 - 3 sessions per week consisting of 3 sets of the exercise. Set 1 with 12 reps, set 2 with 10 reps and set 3 with 8 reps.
15764037|NCT04744181|Drug|Ferric carboxymaltose|administration of a single dose of ferric carboxymaltose in those patietns who fulfill the inclusion criteria
15764038|NCT04744181|Drug|B vitamin|administration of a single dose of B vitamin in those patietns who fulfill the inclusion criteria
15764039|NCT04744181|Drug|Folic acid|administration of a single dose of folic acid in those patietns who fulfill the inclusion criteria
15764040|NCT04744168|Other|Acupuncture|Puncture of 5 points 4GI, 6RP, 34VB, 36E, 3F
15764041|NCT04744168|Other|Placebo Acupuncture|Puncture of point HM
15764042|NCT04744155|Behavioral|Multi-Level Intervention|Behavioral intervention that assesses uptake of contraception and seeks follow-up care.
15764043|NCT04744155|Behavioral|Enhanced Standard of Care|Behavioral intervention that assesses uptake of contraception from follow-up care.
15764044|NCT04744142|Drug|Ketone supplementation|Subjects receive either placebo or ketone ester supplementation
15764045|NCT04744142|Dietary Supplement|Increased protein intake|Subjects receive either normal or increased protein intake
15764046|NCT04744129|Drug|NN414|To investigate the role of NN414 on cerebral hemodynamic in migraine patients
15764047|NCT04744129|Drug|Saline|To investigate the role of NN414 compared with saline cerebral hemodynamic in migraine patients.
15764048|NCT04744116|Other|Cellular Therapy|Given ds-MSCs IV
15764049|NCT04744116|Drug|Ruxolitinib|Given PO
15764050|NCT04744103|Drug|TCA|Patients will receive a TCA peel as a treatment for their actinic cheilitis.
15764051|NCT04744090|Drug|Roflumilast|"Roflumilast 500 mcg daily for up to 28 days
~Total follow up time will be 28 days.
~Proinflammatory parameters will be assessed at baseline, day 7, day 14, and at the end of treatment.
~Roflumilast will be combined with standard of care for ARDS.
~During hospitalization, clinical and laboratory data will be recorded daily in the medical history of the patient and in data collection table of the study.
~During hospitalization, adverse drug reaction will be monitored clinically and by laboratory tests.
~In case of an adverse effect or a need to discontinue the treatment, roflumilast should be suspended."
15764052|NCT04744090|Drug|Placebo|Placebo (identical to roflumilast dosage form) will be used for placebo-comparator group.
15764053|NCT04744077|Behavioral|Influencer Instagram account|Participants randomized to this group will follow a public Instagram account. This account was chosen because they have a strong following (over 600,000 followers) and it is a public account that anyone can follow. The content shared on this page is motivational and community driven. There is a focus of healthy living with an emphasis on exercise. Additionally, there are no paid sponsorships or radical exercise advice, which is common on other influencer pages. The Co-PIs determined that this page accurately represents the exercise-related content that is readily available on Instagram. The research team will not have control over the content of this account, but the account holder will be notified about the study.
15764079|NCT04743856|Behavioral|PAT|Participants will receive a physical activity tracker and encouragement to increase activity.
15764080|NCT04743843|Device|Omnyx Dynamyx Software|Digital pathology image management and viewing software.
15764164|NCT04743193|Other|8% sevoflurane low flow anesthesia|For 35 patients after reaching 1 (MAC) level with 1 lt / min fresh gas flow and 8% sevoflurane concentration in the initial phase, maintenance of anesthesia will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration, targeting 1 MAC. .
15764054|NCT04744077|Behavioral|Research study Instagram account|Intervention arms will deliver the same exercise-related content on the same schedule on the intervention Instagram accounts. The arms will deliver 13-weeks worth of content which goes through the last possible day of the intervention. The structure was based on feedback from stakeholders in a formative focus group. All of the content delivered through the accounts is evidence-based and referenced from reputation organizations/agencies such as the American College of Sports Medicine, American Heart Association, Center for Disease Control, and World Health Organization. Each Co-PI will post videos to answer participant questions. To ensure that the content between both groups is the same, the Co-PIs will meet to determine which questions to answer and draft the response.
15764055|NCT04744064|Dietary Supplement|Protein and carbohydrate|Intake of 2 x 250 ml of either protein (750 KJ, 21.0 g protein (milk protein), 15.0 g carbohydrate, 4.5 g fat ) or carbohydrate ( 750 KJ, 0 g protein, 0 g fat and 49.2 g carbohydrate (2:1 ratio of maltodextrin: fructose))
15764056|NCT04744051|Drug|50 Adipose Derived Stem Cell Infusion|Each participant in this arm will receive a single dose of 50 million cultured adipose derived stem cells derived from their own adipose (fat) tissue via infusion therapy delivery over the course of one hour.
15764057|NCT04744051|Drug|150 Adipose Derived Stem Cell Infusion|Each participant in this arm will receive a single dose of 150 million cultured adipose derived stem cells derived from their own adipose (fat) tissue via infusion therapy delivery over the course of one hour.
15764058|NCT04744051|Drug|300 Adipose Derived Stem Cell Infusion|Each participant in this arm will receive a single dose of 300 million cultured adipose derived stem cells derived from their own adipose (fat) tissue via infusion therapy delivery over the course of one hour.
15764059|NCT04744051|Drug|Placebo Infusion|Each participant in this arm will receive a single dose of placebo. Upon completion of the study each placebo participant will with be given the option to be treated with their cultured adipose derived stem cells derived from their own adipose (fat) tissue via infusion therapy delivery over the course of one hour. Dosage for the crossover will be determined by the PI following review of data collected from the other arms of the study.
15764060|NCT04744038|Device|Positive Airway Pressure (PAP) Therapy|PAP therapy supplies pressurized air from the flow generator to the upper airway via air tubing and a mask to prevent the repetitive collapse of the upper airway during sleep.
15764061|NCT04744025|Device|Microfluidics chamber|Unwashed sperm will be placed into the inlet chamber of the microfluidics device. The most motile sperm will swim to the outlet chamber, and these sperms will be used for intracytoplasmic sperm injection (ICSI) into the eggs.
15764062|NCT04744025|Other|Density Gradient Centrifugation|Sperm will be washed and centrifuged according to standard protocol, and these washed sperm will be used for ICSI.
15764063|NCT04744012|Procedure|Modified Periostal Pocket Flap Technique|"After local anesthesia, a full thickness flap was elevated from the lingual wall and a partial thickness flap was performed in the buccal one. After that, the buccal periosteum was detached and dental implants were placed following the biological drilling protocol, getting autologous bone particles from the implant site.
~Patient's blood collection was performed and the plasm obtained was poured down on a sterile container and mixed with autologous bone particles collected previously during the drilling procedure. Finally the graft was placed in the pocket prepared previously and the surgical wound was sutured in two planes."
15764064|NCT04743999|Other|Quality of life questionnaire|We will evaluate patients' quality of life with a series of questionnaires at baseline, 3, 6, 12, and 24 months after surgical staging. These are prospectively validated questionnaires and include FACT-G (physical and functional well-being sections), FACT-En (additional concerns section), FACT/GOG-NTX-4 (additional concerns section), and FACT-C (items C3 and C5).These sections will be combined into one single form for ease of completion for the patients (a total of 36 items).
15764065|NCT04743986|Biological|Platelet Rich Plasma (PRP)|RegenLab, Lausanne, Switzerland
15764066|NCT04743986|Drug|Corticosteroid (CS)|40mg/ml triamcinolone in 2 ml 0.5% bupivicaine
15764067|NCT04743973|Device|Muse S™ Headband system|Brain sensing headband that measures brain activity by detecting electrical impulses created by the brain.
15764068|NCT04743960|Dietary Supplement|Time-of-day of parenteral nutrition provision|Parenteral nutrition will be provided during the nighttime followed by daytime.
15764069|NCT04743947|Other|No intervention; observational study|no intervention
15764070|NCT04743934|Drug|Flibanserin 100 MG|Flibanserin 100mg tablets taken by mouth daily at bedtime
15764071|NCT04743934|Drug|Placebo|Visually identical placebo tablets taken by mouth daily at bedine
15764072|NCT04743934|Drug|Androgen deprivation therapy|Androgen deprivation therapy consisting of a GnRH agonist or antagonist, choice of agent at discretion of treating physician.
15764074|NCT04743908|Other|Social Network Strategy + COVID-19 messaging|Contextually adapted and theory-driven messages - misinformation correction and self-affirmation - to increase awareness, self-efficacy and community engagement in our adapted Social Network testing Strategy (SNS). SNS is an evidence-based testing intervention that has been widely used in multiple settings with marginalized individuals (ie substance-users) who facilitate the recruitment of their social contacts into testing services.
15764075|NCT04743895|Device|Stainless Steel Wire Cerclage|Wire cerclage used to close sternum after cardiothoracic surgery.
15764076|NCT04743869|Device|Kyphos FS™ Bone Substitute|Dorsal instrumentation via Longitude II (Medtronic Austria GmbH/Vienna) and balloon kyphoplasty are performed. KyphOs FS™ bone cement will be introduced in the fractured vertebral body.
15764077|NCT04743869|Device|KYPHON ActivOs® Bone Cement with Hydroxyapatite|Dorsal instrumentation via Longitude II (Medtronic Austria GmbH/Vienna) and balloon kyphoplasty are performed. KYPHON ActivOs® Bone Cement with Hydroxyapatite will be introduced in the fractured vertebral body.
15764081|NCT04743830|Other|Neurodevelopmental Treatment (Bobath) + Scapular Training|The Bobath concept for 40 minutes will be formed according to the needs of the individual and involve the upper limb, trunk and lower limb. It will be performed with 20 minutes scapular training including scapular exercise such as Proprioceptive Neuromuscular Facilitation (PNF), dynamic hug, towel-wall slide, scapular punch exercises etc. 3 days a week for 8 weeks.
15764082|NCT04743830|Other|Neurodevelopmental Treatment (Bobath)|The Bobath concept for 60 minutes will be formed according to the needs of the individual and involve the upper limb, trunk and lower limb. It will be performed 3 days a week for 8 weeks.
15764083|NCT04743817|Device|OtoSet - Ear Cleaning System|Up to five (5) cleaning cycles using the OtoSet - Ear Cleaning System
15764084|NCT04743804|Biological|Ravulizumab|Body weight-based doses of ravulizumab will be administered intravenously as loading dose regimen followed by maintenance dosing every 8 weeks.
15764085|NCT04743804|Other|Placebo|Matching placebo
15764086|NCT04743804|Other|Best Supportive Care|Participants will receive medications, therapies, and interventions per standard hospital treatment protocols (unless specifically prohibited by the protocol).
15764087|NCT04743791|Drug|Dupilumab|Dupilumab is supplied as a sterile aqueous solution for SC injection at the concentration of 175 mg/mL in glass pre-filled syringe to deliver 200 mg in 1.14mL.
15764088|NCT04743791|Other|Placebo|Sterile placebo for dupilumab will be provided in identically matched glass pre-filled syringe to deliver 200 mg in 1.14mL, which will match dupilumab 200 mg (1.14mL).
15764089|NCT04743778|Behavioral|Virtual Diabetes Self-Management Education and Support|Diabetes self-management education and support delivered through Zoom for health.
15764090|NCT04743778|Behavioral|Resources|Newsletters, pedometers, and community resources.
15764091|NCT04743765|Other|Accelerated medical clearance and surgery|Rapid medical clearance with targeted arrival to the operating room within 6 hours of diagnosis of a hip fracture requiring surgical repair.
15764092|NCT04743739|Drug|Rituximab|Rituximab 1000mg, I.V. on Days 1 and 181, and will be retreated or not at Days 15 and 195 according to the CD19+ B cell count.
15764093|NCT04743739|Drug|cyclosporine|cyclosporine (CsA) will be started at a dose of 3mg/kg/d and adjusted according to the blood levels of the CsA. CsA will be tapered after 6 months and discontinued over a three month period.
15764094|NCT04743713|Other|UWRI-Tr|Questionnaire
15764095|NCT04743700|Procedure|Piezocision|Piezocisions with the help of piezotome , mesial and distal to a canine (in a vertical line) with the help of piezotome. These piezocisions will be performed on the buccal cortical bone only, 2-3mm below the alveolar crest level, 2mm deep into the bone under local anaesthesia (2% lidocaine with 1:100,000 epinephrine) and with standard asepsis, and gingival overlying will be incised first with blade number 15 in a Bard Parker handle . The exact location of incision will be determined by transgingival probing mesial and distal to the canine to know the alveolar crest level and to this measurement 2-3 mm is added and then 5mm incision is given in gingiva and overlying mucoperiosteum in a vertical line apically to expose the underlying bone.
15764096|NCT04743700|Procedure|Micro-osteoperforations|Three MOPs mesial and three MOPs distal to canine(in a vertical line) with the help of minisrew implant driver (fig.2). These MOPs will be performed on the buccal cortical bone only, 2-3 mm below the alveolar crest level, 2mm deep into the bone under local anaesthesia (2% lidocaine with 1:100,000 epinephrine) and with standard asepsis, and no flap will be raised. The exact location of first MOP will be determined by transgingival probing mesial and distal to the canine to know the alveolar crest level and to this measurement 2-3 mm is added. The location of second MOP at 5mm apically in a vertical line and third MOP at 5 mm apically to second MOP
15764097|NCT04743687|Drug|Zanubrutinib|Oral Zanuburutinib, 160mg twice a day
15764098|NCT04743661|Drug|Irinotecan|"Irinotecan is a semisynthetic water-soluble analog of camptothecin (a plant alkaloid isolated from Camptotheca acuminata). Irinotecan is available in single-dose amber glass vials in 40 mg (2 mL) and 100 mg (5 mL), 300 mg (15 mL), and 500 mg (25 mL).
~Patients on Stratum 1 will be given irinotecan at 50 mg/m2/day IV on Days 1 through 5 of each chemotherapy course."
15764099|NCT04743661|Drug|Temozolomide|"An orally administered alkylating agent, a second generation imidazotetrazine. A prodrug of MTIC, temozolomide spontaneously decomposes to MTIC at physiologic pH. Exerts its effect by cross-linking DNA. Temozolomide capsules are available in six different strengths (5, 20, 100, 140, 180, 250 mg). The capsules vary in size, color, and imprint according to strength. In the US, capsules are packaged in 5-count and 14-count bottles.
~Patients on Stratum 1 will be given temozolomide at 150 mg/m2/dose PO on Days 1-5 of each chemotherapy course."
15764100|NCT04743661|Drug|Bevacizumab|"Bevacizumab is a recombinant humanized anti-vascular endothelial growth factor (anti-VEGF) monoclonal antibody. Bevacizumab is supplied as a clear to slightly opalescent, sterile liquid ready for parenteral administration. Each 400 mg (25 mg/mL, 16 mL fill) glass vial contains bevacizumab with phosphate, trehalose, polysorbate 20, and Sterile Water for Injection.
~Patients on Stratum 1 will be given bevacizumab at 10 mg/kg/day IV on Days 1 and 15 of each chemotherapy course, with the exception of the last course of Induction Chemotherapy (i.e., Course 2 or 4) where it will be administered on Day 1 only."
15764101|NCT04743661|Drug|Omburtamab I-131|"Omburtamab is a murine IgG1 monoclonal antibody (mAb) against B7-H3 (CD276) manufactured by in vivo growth of the hybridoma cell line without the use of animal-derived components. Omburtamab will be radiolabeled with iodine-131 at a designated radiolabeling facility. 131I-omburtamab is supplied as a sterile, injectable, radioactive product in a vial. Each supplied vial will contain enough radioactivity to prepare 50 mCi of 131I-omburtamab, formulated in 3.5-4 mL of solution. 131I-omburtamab should be administered via an intraventricular access device (i.e., Ommaya catheter or programmable VP shunt). Radioimmunotherapy consists of 56 days.
~Patients on Stratum 1 will receive a therapeutic dose of 50 mCi cRIT 131I-omburtamab on Days 8 and 36 of Radioimmunotherapy.
~Patients on Stratum 2 will receive a therapeutic dose of 50 mCi cRIT 131I-omburtamab on Days 1 and 29 of Radioimmunotherapy."
15764102|NCT04743661|Drug|Liothyronine|Liothyronine (or equivalent) will be given as premedication for 131I-omburtamab to prevent thyroid accumulation. Liothyronine (or equivalent) will be administered at 25 µg PO, NG, or G-tube (if weight < 25 kg) or 50 µg PO, NG, or G-tube (if weight ≥ 25 kg) daily starting on Day 1 of Radioimmunotherapy (for Stratum 1 patients) or Day 1 of Dosimetry (for Stratum 2 patients), with a mandated minimum of 7 days before each 131I-omburtamab injection and 14 days after each 131I-omburtamab injection. On the day of the 131I-omburtamab injection, administer any time before the injection.
15764132|NCT04743414|Drug|CTP-543|Itraconazole in solution dosage form
15764103|NCT04743661|Drug|SSKI|SSKI (potassium iodide) will be given as premedication for 131I-omburtamab to prevent thyroid accumulation. SSKI (potassium iodide) will be administered as 7 drops (~0.35 mL) PO, NG, or G-tube daily starting on Day 1 of Radioimmunotherapy (for Stratum 1 patients) or Day 1 of Dosimetry (for Stratum 2 patients), with a mandated minimum of 7 days before each 131I-omburtamab injection and 14 days after each 131I-omburtamab injection. On the day of the 131I-omburtamab injection, administer any time before the injection.
15764104|NCT04743661|Drug|Dexamethasone|Dexamethasone will be given as premedication for 131I-omburtamab to prevent possible meningeal inflammatory reaction. Starting within 24 hours prior to each 131I-omburtamab injection, dexamethasone will be administered orally at 0.5 mg (if weight < 15 kg) or 1 mg (if weight ≥ 15 kg) twice-daily doses for a total of 6 doses to alleviate infusion-related AEs: Two doses starting 24 hours pre-131I-omburtamab injection, two doses on the day of the injection (can be given before or after), and two doses 24 hours post-131I-omburtamab injection.
15764105|NCT04743661|Drug|Antipyretic|An antipyretic (e.g., oral acetaminophen [15 mg/kg, 650 mg maximum] or equivalent) will be given as premedication for 131I-omburtamab within 1 to 3 hours before each 131I-omburtamab injection.
15764106|NCT04743661|Drug|Antihistamine|An antihistamine (e.g., IV diphenhydramine [1 mg/kg, 50 mg maximum] or equivalent) will be given as premedication for 131I-omburtamab within 1 to 3 hours before each 131I-omburtamab injection.
15764107|NCT04743661|Drug|anti-emetics|An anti-emetic (e.g., IV ondansetron [0.25 mg/kg, 16 mg maximum] or equivalent) will be given as premedication for 131I-omburtamab within 1 to 3 hours before each 131I-omburtamab injection.
15764108|NCT04743648|Behavioral|Innovative Thinking Development Program (ITDP)|With the implementation of the program, nursing students are expected to develop innovative thinking skills.
15764109|NCT04743635|Device|minimally invasive procedure|Procedure for reducing cellulite
15764110|NCT04743622|Drug|Monoprost|preservative-free latanoprost 1 drop once a day for 12 weeks to target eyes
15764111|NCT04743622|Drug|Xalatan|preserved latanoprost 1 drop once a day for 12 weeks to target eyes
15764112|NCT04743609|Diagnostic Test|nasopharyngeal samples|rapid antigen test for Sars Cov-2, influenza and RSV. RT-PCR for a subgroup of 400 patients
15764113|NCT04743596|Device|High-Definition Videobronchoscopy|Endoscopic inspection and endobronchial biopsy with standard forceps during high-definition videobronchoscopy.
15764114|NCT04743583|Device|Endosonography B-mode examination|Endobronchial ultrasound (EBUS) or Endoscopic with bronchoscope (EUS-B) B-mode examination and sampling, when indicated, of lymphadenopathy
15764115|NCT04743570|Drug|Placebo treatment|Active drug/placebo is given for the first 5 days of admission.
15764116|NCT04743570|Drug|Methylnaltrexone treatment|Active drug/placebo is given for the first 5 days of admission.
15764117|NCT04743557|Drug|DYN101|DYN101, is a constrained ethyl gapmer ASO directed against human DNM2 pre-mRNA
15764118|NCT04743544|Drug|Voriconazole|This is an observational study and only the patients already on voriconazole treatment will be included in the study.
15764119|NCT04743531|Behavioral|HEROs|Intervention Description: The intervention will consist of a 6-week family workshop series, held one evening per week for six consecutive weeks. The intervention modules will be delivered by trained researchers at two preschool sites in rural Colorado in Fall 2019 and Spring 2020. The primary caregiver and preschool child will be the targets of the study. Each of the workshops will be structured to include joint caregiver-child activities and programming that is tailored for caregivers and children individually. Caregivers will learn about and engage in activities related to healthy eating and picky eating; physical activity and motor development; and parenting strategies. Children will participate in activities focused on healthful eating and physical activity that supports content their parents are learning.
15764120|NCT04743518|Other|Aortic pulse wave velocity|Aortic pulse wave velocity (aPWV) is a measure of aortic stiffness
15764121|NCT04743518|Other|carotid intima media thickness (CIMT)|carotid intima media thickness (CIMT)
15764124|NCT04743492|Behavioral|cognitive behavioral therapy|cognitive behavioral therapy delivered by clinical psychologists in order to help patients gain coping skills.
15764125|NCT04743479|Diagnostic Test|high-resolution MRI/CT examinations|Participants will undergo annual questionnaire survey, laboratory tests and high-resolution MRI/CT examinations of the pancreas. Any suspicious lesions will be further examined by endoscopic ultrasound (EUS).
15764126|NCT04743466|Other|Electronic Health Record Review|Biobank records are reviewed
15764127|NCT04743453|Drug|Dapagliflozin|Dapagliflozin 10 mg: Study drug will be administered by once-daily orallly. The first dose MUST be started within 1 and 7 days after randomization. The subsequent doses will be administered 24 ± 4 hours after the previous dose.
15764128|NCT04743453|Drug|Placebo|Placebo will be administered by once-daily orallly. The first dose MUST be started within 1 and 7 days after randomization. The subsequent doses will be administered 24 ± 4 hours after the previous dose.
15764129|NCT04743440|Device|Bronchoscopic endotracheal intubation through a supraglottic airway device|Prior to trial commencement, participants will be asked to watch a video demonstrating preparation and conduction of the procedure (bronchoscopic endotracheal intubation through a supraglottic airway device) in a patient not involved in the project. Afterwards they will submit an online test, examining knowledge of the procedure relating to the procedure checklist. After participants have watched the demonstration video and submitted the online test, trial investigator will demonstrate the procedure in the manikin; subsequently, they have the opportunity to train the procedure in the manikin with both Igel and Auragain - training estimated to take less than 30 minutes. Afterwards, they will have the opportunity to train the procedure on manikins, on their own discretion, as per usual standards for maintaining airway competence at the Anaesthesiology Department.
15764130|NCT04743427|Other|hot pack and exercises|20-minute hot pack,and three active exercises: (a) chin tucks in supine lying with the head in contact with the floor, (b) active Standing Shoulder pull back , and (c) scapular plane shoulder elevation. (3 sets of 10 repetitions for all the 3 exercises)
15764131|NCT04743427|Device|body blade(BB)|The Body-blade (Classic, Mad Dogg Athletics, USA), an elastic pole exercise tool with 122 cm in length, 0.68 kg, 4.3 cm in width,based on oscillatory/vibration motions that have been used in training or rehabilitation.The body blade works by rapidly changing directions at a low-frequency rhythm of approximately 4.5 Hz (cycles per second )
15764133|NCT04743401|Other|Tele-exergaming Tablet|"The Tele-Exergame platform virtually supervises exercise tasks and coaches patients to perform evidence-based foot and ankle exercises that have been designed to improve balance, cognition, and lower extremity vascular health.
~The exergame program uses a game-based approach, similar to playing a video game, which helps to increase patient motivation and engagement in the cognitively demanding exercise program."
15764134|NCT04743388|Biological|BNT162b2|Vaccine against SARS-Cov-2 of the Pfizer/BioNTech companies
15764135|NCT04743388|Biological|Other vaccine against SARS-Cov-2|Any other vaccine authorized and administered by the Greek Ministry of Health against SARS-Cov-2
15764136|NCT04743375|Other|wound dressing application|Sericin dressing with collagen or Bactigras will be used as a primary dressing for treating the STSG donor site.
15764137|NCT04743362|Diagnostic Test|Dermoscopic imaging|The skin lesion will be imaged before application of alcohol (spray/wipe) and after application of alcohol (spray/wipe). The dermatoscope/camera with dermoscopy imaging capabilities, including but not limited to VEOS® SLR (Canfield Scientific, Inc.), will be placed on/near the area(s) of interest. Images will be captured in polarized and/or nonpolarized modes and contact and/or non-contact modes.
15764138|NCT04743362|Diagnostic Test|3-dimensional total body photography|Participants will stand in the center of an imaging station consisting of 92 high-resolution cameras. Image capture by all cameras will occur simultaneously, (approx. 3 milliseconds). Within a few minutes, specialized software will process and assemble the images into a 3D avatar - a digital model of the patient's skin - showing all his or her lesions.
15764139|NCT04743362|Diagnostic Test|Confocal microscopy|CM imaging (Vivascope®, Caliber Imaging and Diagnostics, Rochester, NY) will be performed using an arm-mounted CM device (Vivascope1500, Caliber I.D., Inc.) or using a handheld CM device (Vivascope3000, Caliber I.D., Inc.).
15764140|NCT04743362|Diagnostic Test|Optical Coherence Tomography imaging|OCT subsurface imaging shows structural-level morphology (epidermal and dermal layers) in skin down to the deeper reticular dermis.
15764141|NCT04743362|Diagnostic Test|Ultrasound|US imaging allows assessment of depth, Doppler vascular imaging, and elastography features of skin lesions.
15764142|NCT04743362|Diagnostic Test|Hyperspectral imaging|Hyperspectral imaging shows biochemical information regarding the distribution of skin melanin and hemoglobin50. SkinSpect™ is a form of a hyperspectral dermatoscope.
15764143|NCT04743362|Diagnostic Test|Electrical impedance spectroscopy|Electrical impedance spectroscopy (EIS) measures skin's resistance to the flow of alternating electric currents to differentiate benign and malignant lesions.
15764144|NCT04743362|Diagnostic Test|Patient self-imaging|Clinical and dermoscopy self-imaging by patients can be accomplished using mobile phone technology. In the case of dermoscopy, this requires a small dermatoscope attachment for the phone.
15764145|NCT04743349|Procedure|Steam inhalations|Exposure of airway mucosae to humidified steam through steam inhalation for at least 20 min (4 cycles of 5 min) daily, for 10 days.
15764146|NCT04743336|Other|Measuring pocket depth|Probing pocket depth (PPD = distance between gingival margin and bottom of the periodontal pocket)were evaluated in each patient. All periodontal measurements were recorded at six sites around each tooth by a periodontal probe excluding third molar
15764147|NCT04743310|Drug|tozuleristide|tozuleristide 24mg administered intravenously 1-24 hours prior to surgery
15764148|NCT04743310|Device|Canvas imaging system|imaging device attached to surgical microscope
15764149|NCT04743310|Procedure|Surgical resection of tumor|Standard of care surgical resection of tumor
15764150|NCT04743297|Drug|Prostaglandin E2 (Propess)|Propess - The vaginal insert is removed 24 h after the application. It is only to be removed earlier in case of the onset of active labour or at the occurrence of hyperstimulation.
15764151|NCT04743297|Drug|Prostaglandin E2 (Prostin)|Prostin - 3 mg vaginal tablet is placed in the posterior vaginal fornix. Dose can be repeated every 8 hours till onset of active labour or the occurrence of hyper-stimulation.
15764152|NCT04743271|Other|High-Fat Diet|The diet will consist of a breakfast, lunch, dinner, and snack
15764153|NCT04743271|Other|Low-Fat Diet|The diet will consist of a breakfast, lunch, dinner, and snack
15764154|NCT04743258|Procedure|MAXILLARY PREMOLAR EXTRACTION|Patients will undergo bilateral maxillary 1st premolar extraction before bonding followed by leveling & alignment.
15764155|NCT04743258|Procedure|DISTALIZATION|Maxillary arch will be distalized with the help Zygomatic miniplates will be placed bilaterally.
15764156|NCT04743245|Device|TherOx DownStream System|SSO2 Therapy with Therox downstream System after Percutaneous Coronary Intervention (PCI)
15764157|NCT04743245|Device|PCI|Standard Care of PCI
15764158|NCT04743232|Other|Decision tool for clinicians|Clinical decision aid, using a structured approach to advanced care directives and a comprehensive view of available risk scores.
15764159|NCT04743219|Procedure|Selective removal to soft dentin, Biodentine|"Carious tissue removed until its complete elimination from the lateral walls of the cavity using a round tungsten carbide bur at low speed until consistency of hard dentin around perimeter. With a manual excavator, the central cariogenic biomass will be removed, specifically the superficial part of the necrotic and demineralized caries dentin.
~In the Biodentine group, Biodentine (Septodont) will be placed on the base of the cavity with a thickness of 2 mm.
~The last step will be to perform a definitive direct resin restoration according to clinical indication."
15764160|NCT04743219|Procedure|Selective removal to soft dentin, No Base|"Carious tissue removed until its complete elimination from the lateral walls of the cavity using a round tungsten carbide bur at low speed until consistency of hard dentin around perimeter. With a manual excavator, the central cariogenic biomass will be removed, specifically the superficial part of the necrotic and demineralized caries dentin.
~In the No base group, no bioactive material will be placed as a liner, the 3M Scothcbonf Universal Plus adhesive will be placed directly over the remaining dentin surface.
~The last step will be to perform a definitive direct resin restoration according to clinical indication."
15764161|NCT04743206|Device|Standard Airway Clearance device|A large majority of our patients will be using VEST therapy as their standard of care airway clearance
15764162|NCT04743206|Device|Portable Internal Airway Percussion device|Smart One® portable home spirometer
15764163|NCT04743193|Other|2.5 %sevoflurane|for 35 patients after reaching 1 MAK level with 4 lt / min fresh gas flow and 2,5% sevoflurane concentration in the initial phase, maintenance of anesthesia will be continued with 0.5 lt / min fresh gas flow and 2 -4% sevoflurane concentration with the target of 1 minimum alveolar concentration
15764168|NCT04743154|Other|Time to procedure|To perform percutaneous coronary intervention of non-culprit vessels in patients admitted with a STEMI and multivessel disease.
15764170|NCT04743128|Behavioral|Exercise|The experimental group started an exercise program to achieve 65% to 80% of the maximum heart rate by using a pulsometer that measured the heart rate in order to get to the moderate intensity activity goal. The exercise session was 60 minutes long, three times per week, completing 180 minutes per week of moderate intensity exercise, for 12 weeks in total.
15764171|NCT04743115|Drug|BS HH 002.SA|"The Dose Escalation Part is a 3+3 design dose escalation study to determine the MTD of BS HH 002.SA in up to approximately 30 patients with the protocol AML indication or high risk MDS. Cohorts of 3 patients will be sequentially assigned to receive BS HH 002.SA at escalating DLs following the standard 3+3 dose escalation design, with 3 to 6 patients at each DL.
~Cohort Expansion Part: Following determination of the MTD, the study will continue at the MTD and/or a lower DL"
15764172|NCT04743102|Procedure|multi-points and full-thickness Biopsy|Four points around the tumor site and center of the tumor site full-thickness Biopsy
15764173|NCT04743102|Diagnostic Test|traditional cCR|diginal examination, endoscopy test, rectal MRI, and serum CEA level
15764174|NCT04743089|Device|ERCP using SpyGlass™ DS Direct Visualization System|Lithotripsy and stone removal will be performed using ERCP and Spyglass system to patients with IHD/EHD stone, which is difficult to remove through conventional ERCP. The SpyGlass™ DS Direct Visualization System will be applied directly into the bile duct via the working channel of the duodenoscope. Under the high-resolution digital imaging, lithotripsy such as EHL could be done.
15764175|NCT04743089|Other|PTCS|A historical cohort of patients who underwent PTCS to remove bile duct stones which is difficult to treat by ERCP.
15764176|NCT04743076|Procedure|Endovascular treatment|Endovascular treatment
15764177|NCT04743076|Other|Standard medical treatment|Standard medical treatment
15764178|NCT04743063|Drug|sacubitril/valsartan|Initiation of sacubitril/valsartan, identified using prescription fill in pharmacy claims
15764179|NCT04743063|Drug|Angiotensin II Receptor Blockers|Initiation of ARBs, identified using prescription fill in pharmacy claims
15764180|NCT04743050|Drug|Fatty Acids, Unsaturated|All participants from Experimental Groups will receive supplementation of different fractions of EFAs esters for six months daily. Control Group will be monitored with the same tests, but will not receive any supplementation.
15764181|NCT04743050|Diagnostic Test|Diagnostic Tests|All participants will have laboratory tests marking: CRP, fasting glucose, lipid profile, total blood count, and additional tests, which will include blood pressure measurements and measurements of body mass and composition on a specialized body composition analyzer (InBody 270). All the mentioned tests will be performed at the time of joining the research program, after 3 months (in the middle of the research program) and after 6 months (at the end of the research program).
15764182|NCT04743037|Behavioral|iSMART|This patient-centered and participation-focused self-management intervention will help individuals develop strategies to manage chronic conditions and support their full participation in meaningful life activities.
15764183|NCT04743011|Drug|Heparin sodium|Nebulized inhalation of 5 mL of a solution containing high molecular weight heparin - enriched heparin - 2.5mg/mL and 0.9% saline solution, every 4 hours for 7 days, except during the nighttime (5 doses/day)
15764184|NCT04743011|Drug|Placebo|Nebulized inhalation of 5 mL of 0.9% saline solution, every 4 hours for 7 days, except during the nighttime (5 doses/day)
15764185|NCT04742998|Other|Acoustic-phonetic decoding task (DAP)|Completion of speech-related quality of life autoquestionnaires Routine speech assessment Acoustic-phonetic decoding task (DAP) two lists of 16 pseudo-words
15764186|NCT04742985|Dietary Supplement|Green tea combined extracts group|Green tea combined extracts 320 mg/day (main compound 62,5 mg for A group, 125 mg for B group) during 8 weeks
15764187|NCT04742985|Dietary Supplement|Placebo group|Placebo 320 mg/day during 8 weeks
15764188|NCT04742972|Radiation|SABR|SABR is delivered to all sites of oligometastasis with continuation of Enzalutamide. Further oligo-progressive lesions may be treated with SABR if possible. Upon progression at sites not amenable to SABR, the patient may receive any of the options in SOC Arm.
15764189|NCT04742972|Other|SOC|"Three options:
~Continuation of Enzalutamide
~Observation
~Switch to next line treatment"
15764192|NCT04742946|Other|Standard Physiotherapy program|Respiratory and Standard Physiotherapy
15764193|NCT04742946|Other|Telerehabilitation|Online Physiotherapy services
15764194|NCT04742933|Other|There is no intervention in this observational trial|There is no intervention in this observational trial
15764195|NCT04742920|Device|Middle Meningeal Artery Embolization|MMA embolization using the Onyx™ non-adhesive liquid embolic agent within 24 hours after randomization in addition to standard management
15764196|NCT04742920|Procedure|Standard Management|"Procedure : Surgical Management Surgical evacuation of the subdural hematoma
~Other: Conservative Management Standard medical management: drug treatment and/or observation"
15764197|NCT04742907|Drug|TU-100|Treatment with investigational product
15764198|NCT04742907|Drug|Placebo|Treatment with placebo product
15764199|NCT04742894|Behavioral|Visual Feedback Training|Participants will be trained to work with a computer setup to control the position of a visual cursor on the screen using their speech while their auditory feedback is altered. The goal of the training is to help improve speech production and motor control ability.
15764200|NCT04742881|Procedure|Low pressure + microsurgical instruments|Low pressure pneumoperitoneum (5-7mmHg) and use of microsurgical instruments (3mm and 5mm instruments)
15764201|NCT04742881|Procedure|Low pressure + standard instruments|Low pressure pneumoperitoneum (5-7mmHg) and use of standard instruments (5mm and 10mm instruments)
15764202|NCT04742868|Procedure|ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITH BONE GRAFT|Quadriceps tendon with pattlar bone will used for grating
15764203|NCT04742868|Procedure|ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH HAMSTRING TENDON GRAFT|Hamstring tendon with will used for grating
15764963|NCT04736641|Other|Survey study|Japanese Orthopaedic Association Hip Disease Evaluation Questionnaire (JOAHDEQ) will be applied
15764204|NCT04742868|Procedure|ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH QUADRICEPS TENDON WITHOUT BONE GRAFT|Quadriceps tendon without pattlar bone will used for grating
15764205|NCT04742868|Other|Rehabilitation protocol|All patients will receive six months rehabilitation program which aim to recover the strength and function
15764206|NCT04742855|Dietary Supplement|Probiotics|Study product is packaged as powders in a sachet. Participants and their parents will be instructed to dissolve the powder in water or milk, and to drink it in the morning and/or evening.
15764207|NCT04742842|Biological|COVIGEN 0.8 mg ID or Placebo ID|2 doses of COVIGEN 0.8 mg ID or Placebo ID will be given at Day 1 and Day 29.
15764208|NCT04742842|Biological|COVIGEN 2.0 mg IM or Placebo IM|2 doses of COVIGEN 2.0 mg IM or Placebo IM will be given at Day 1 and Day 29.
15764209|NCT04742842|Biological|COVIGEN 4.0 mg IM or Placebo IM|2 doses of COVIGEN 4.0 mg IM or Placebo IM will be given at Day 1 and Day 29.
15764210|NCT04742829|Dietary Supplement|INTRAVIT ®|2 tablets per day morning and evening before meals
15764211|NCT04742816|Diagnostic Test|IHX-CL measurements|The distribution of measured IHX-CL values and other continuous variables will be assessed to ensure a parametric distribution.
15764212|NCT04742816|Drug|Iohexol|Iohexol clearance measurement
15764213|NCT04742803|Device|Epistamp|"The patient's entire face will be treated with the Epistamp needling device.
~The following settings will be used as a treatment protocol. Needle length between .02- 1.55 mm"
15764214|NCT04742790|Diagnostic Test|Scalp electroencephalography (EEG)|Resting EEG will be recorded before initiation of the combination treatment (visit 1) and 7-10 days after treatment (visit 2). Drug-induced sedation-related changes in the EEG frequency spectrum. Five minutes of resting EEG eyes-open will be recorded in a quiet room while participants are asked to focus on an image displayed on a wall. Then, they will be asked to close their eyes for an additional 2 minutes. The alpha power ratio eyes open/eyes closed will be computed (alpha attenuation coefficient; Kaida et al., 2006). Changes in this coefficient will be used as a measure of drug-induced sedation.
15764215|NCT04742790|Diagnostic Test|Laser-evoked potentials (LEPs)|Laser-evoked potentials (LEPs) will be recorded before (visit 1) and 7-10 after (visit 2) initiating the combination treatment. Short pulses (50-100 ms) of radiant heat generated by a C02 laser stimulator will be applied to the skin of the left or right hand dorm to briefly and selectively activate heat-sensitive pain receptors. A concomitant EEG recordings will be used to measure the amplitude and latency of the elicited laser-evoked potentials. Changes in LEP amplitude (expressed as percentage of change) will be used as a measure of drug-induced effects on the state of the thermonociceptive system.
15764216|NCT04742790|Diagnostic Test|Cognitive auditory-evoked potentials (P300)|Cognitive auditory-evoked potentials will be recorded before (visit 1) and 7-10 after (visit 2) initiating the combination treatment. Short-lasting auditory tones will be delivered using a three-stimulus oddball paradigm combining standard tones (90% of stimuli), slightly different target tones that the subject must attend and detect (10% of stimuli), and strongly different distractor non-target tones (10% of stimuli). The stimuli will be delivered binaurally using headphones. Participants will be instructed to press a button when they detect a target tone, and to ignore the standard and distractor non-target tones. The EEG recordings will be used to measure the amplitude and latency of the cognitive P3a and P3b potentials (Komerchero & Polich 1999). Changes in P3a/P3b amplitude will be used as a measure of drug-induced effects on cognition (expressed as percentage of change).
15764217|NCT04742790|Diagnostic Test|Cervical somatosensory-evoked potentials|Cervical spinal-cord evoked potentials will be recorded before (visit 1) and 7-10 after (visit 2) initiating the combination treatment. The responses will be elicited by transcutaneous electrical stimulation of the median nerve. The N13 component of this response is mediated by large myelinated non-nociceptive fibers and reflects a segmental postsynaptic response of dorsal horn interneurons at the level of lumbar spinal cord (Cruccu et al., 2008). Changes in magnitude of the N13 will be used as a measure of drug-induced effects on spinal cord function (expressed as percentage of change).
15764218|NCT04742790|Diagnostic Test|Pupillometry|Pupillometry measurements will be performed before (visit 1) and 7-10 after (visit 2) initiating the combination treatment. Pupillometry has been proposed as a method to assess opioid pharmacodynamics. The extent of pupil dilatation can provide an index of nociceptive input via autonomic innervation of the iris muscles, while the extent of the attenuation of this pupillary response during exposure to opioid analgesics could provide an index of pharmacological effects reflecting the extent of opioid receptor occupancy in the CNS. Pupillometry (static pupil diameter, variability of pupil diameter [variation coefficient of pupillary dilation, VCPD, Charier et al. 2017]), light-evoked speed of pupil constriction [maximum pupil constriction velocity, PCV, Connely et al., 2014]) will be measured using a handheld pupillometry device routinely used for clinical evaluations.
15764219|NCT04742790|Diagnostic Test|Saccadic Peak Velocity|The saccadic peak velocity (SPV; m/s) will be measured before before (visit 1) and 7-10 after (visit 2) initiating the combination treatment. Saccadic peak velocity is one of the most sensitive parameters for sedation. Recording of eye movements will be performed in a quiet room with dimmed lightning. Average values of saccadic peak velocity (expressed as degrees/second) of all correct saccades will be measured.
15764220|NCT04742790|Diagnostic Test|Adaptive tracking test|The test will be performed before (visit 1) and 7-10 after (visit 2) initiating the combination treatment. Adaptive tracking is a pursuit-tracking task sensitive to impairment of eye-hand coordination by drugs. It has been proven useful for measuring CNS effects of alcohol, various other psychoactive drugs, and sleep deprivation.
15764221|NCT04742790|Diagnostic Test|Body Sway Test|Body sway will be assessed before (visit 1) and 7-10 after (visit 2) initiating the combination treatment, using a body sway meter and with eyes closed. The body sway meter allows measurement of body movements in a single plane, providing a measure of postural stability. The method has been used to demonstrate effects of sleep deprivation, ethanol and psychoactive drugs. All body movements over a 2-min period are integrated and expressed as millimeters of sway.
15764243|NCT04742699|Drug|Lemborexant (LEM) 5 mg (RMT-combination cohort)|"Pretreatment phase: Continue pre-registration treatment (RMT and BZRA combination therapy) without LEM.
~First treatment phase: Administer LEM 5 mg/day as a substitute for RMT and continue BZRA. Increasing to LEM dose to 10 mg/day is allowed.
~Maintenance phase: Succeed the treatment of the first treatment phase. Changing LEM dose is allowed. Decreasing dose or discontinuation of BZRA is allowed. Rescue administration of Z-drug or RMT is allowed under a defined condition."
15764222|NCT04742790|Diagnostic Test|N-back working memory test|"Working memory performance will be assessed before (visit 1) and 7-10 after (visit 2) initiating the combination treatment. In this test, a series of letters are shown to the participant on a computer screen. The test includes three conditions with increased working memory load. The 0-back condition simply requires to indicate whether the presented letter is the letter X or another letter. In the 1-back condition, participants are requested to indicate whether the displayed letter is identical to the preceding letter. In the 2-back condition, participants are required indicate whether the letter is repeated with one other letter in between (e.g., B … C … B)."
15764223|NCT04742790|Other|Patient-reported outcomes|Before (visit 1) and 7-10 after (visit 2) initiating the combination treatment, but also daily between the two visits, 14 days, 1 month, 3 months and 6 months after treatment initiation, patient-reported outcomes will be collected to assess clinical effects and side-effects of the combination treatmen These include the short form of the Brief Pain Inventory (BPI), the PROMIS PQ-NEURO score for neuropathic pain, the Stanford Sleepiness Scale (SSS), and the PROMIS Neuro-QOL self-assessment of cognitive functioning.
15764224|NCT04742777|Drug|rapamycin|Taken orally 1mg daily for 8 weeks
15764225|NCT04742764|Combination Product|Standard medical therapy|Standard medical therapy (according to the Surviving Sepsis Campaign) will include standard monitoring (pulseoximetry, 5-lead ECG, continuous invasive blood pressure monitoring, central venous cannulation and 24 with PiCCO-technology. Norepinephrine as a vasopressor and dobutamine - if needed - as an inotrope will be administered by the attending physician.
15764226|NCT04742764|Device|Standard medical therapy plus cytokine removal treatment using Cytosorb, with the adsorber changed in every 12 hours|Standard medical therapy, as discussed above will be applied. Furthermore, Cytosorb will be administered as soon as it is possible after randomization but not later than 2 hour (start of the treatment, T0). In a blood pump circuit in pre-haemofilter position, using a kidney replacement device of Fresenius Multifiltrate as a solo therapy or in combination with renal replacement therapy. It will be run in CVVHD, CVVHDF or CVVH mode with a 150 and 200 ml/min blood flow. Anticoagulation will be applied intravenously with heparin, low molecular weight heparin or citrate. The aim of the pump flow rate will be 100-400 mL/min, and the flow rate will be recorded. Possible shock reversal will be assessed by the physician attending. Adsorber cartridges will be changed in every 12 hours. End of the study period (Te): 12 hours after shock reversal, death of the patient, or maximum of five days, whichever happens first.
15764227|NCT04742764|Device|Standard medical therapy plus cytokine removal treatment using Cytosorb, with the adsorber changed in every 24 hours|The standard medical therapy and method of Cytosorb treatment as detailed above will be applied. Adsorber cartridges will be changed in every 24 hours.
15764228|NCT04742751|Drug|Metformin|Dosage and Route of Administration: 500 mg dose/day to be taken orally, increased to 1000 mg dose/day at day 14 through week 24. The dose should be taken immediately following the evening meal and at approximately the same time daily
15764229|NCT04742751|Behavioral|Digital Intervention|"Lifestyle Change Digital Intervention - This is a digital platform that will include a core curriculum focused on diet, exercise, and behavioral strategies for goal setting and self-monitoring to improve diet including a weight loss On Day 1, participants will begin their digital lifestyle intervention using their smart-phone application with their lifestyle coach and peer group.
~On day 14, participants will be contacted by phone (+/- 4 days, day 10 to 18) and adherence assessed using virtual pill counts via phone calls.
~At weeks 4, 8, 16 and 20 a phone-based pill count for adherence and adverse event symptom log will be completed and study medication dispensed.
~At week 12 (interim assessment) and 24 (study-end), the participant will return to St. Jude Children's Research Hospital (SJCRH) for an in-person assessment.
~The digital lifestyle change program will complete at week 24."
15764230|NCT04742738|Biological|GBP510 adjuvanted with Alum (RBD 10μg/dose) - Stage 1|Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with Alum (RBD 10μg/dose) on Days 0 and 28.
15764231|NCT04742738|Other|Normal saline (0.9% sodium chloride solution) - Stage 1|Participants will receive intramuscular (IM) injections of Normal saline on Days 0 and 28.
15764232|NCT04742738|Biological|GBP510 adjuvanted with Alum (RBD 25μg/dose) - Stage 1|Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with Alum (RBD 25μg/dose) on Days 0 and 28.
15764233|NCT04742738|Other|Normal saline (0.9% sodium chloride solution) - Stage 1|Participants will receive intramuscular (IM) injections of Normal saline on Days 0 and 28.
15764234|NCT04742738|Biological|GBP510 adjuvanted with Alum (RBD 10μg/dose) - Stage 2|Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with Alum (RBD 10μg/dose) on Days 0 and 28.
15764235|NCT04742738|Biological|GBP510 adjuvanted with Alum (RBD 25μg/dose)- Stage 2|Participants will receive intramuscular (IM) injections of GBP510 adjuvanted with Alum (RBD 25μg/dose) on Days 0 and 28.
15764236|NCT04742738|Other|Normal saline (0.9% sodium chloride solution)- Stage 2|Participants will receive intramuscular (IM) injections of Normal saline on Days 0 and 28.
15764237|NCT04742725|Drug|Placebo|Placebo
15764238|NCT04742725|Drug|Prothione™ (6g)|Prothione is a pro-Glutathione compound includes free-form amino acids
15764239|NCT04742712|Device|CoronaCheck Device|All participants breath normally into the device for up to 6 minutes
15764240|NCT04742699|Drug|Lemborexant (LEM) 5 mg (Z-Drug-mono cohort)|"Pretreatment phase: Continue pre-registration treatment (Z-drug monotherapy) without LEM.
~First treatment phase: Administer LEM 5 mg/day as a substitute for Z-Drug. Increasing LEM dose to 10 mg/day is allowed.
~Maintenance phase: Succeed the treatment from the first treatment phase. Changing LEM dose is allowed. Rescue administration of Z-drug or RMT is allowed under a defined condition."
15764241|NCT04742699|Drug|Lemborexant (LEM) 5 mg (SUV-mono cohort)|"Pretreatment phase: Continue pre-registration treatment (SUV monotherapy) without LEM.
~First treatment phase: Administer LEM 5 mg/day as a substitute for SUV. Increasing to LEM dose to 10 mg/day is allowed.
~Maintenance phase: Succeed the treatment of the first treatment phase. Changing LEM dose is allowed."
15764242|NCT04742699|Drug|Lemborexant (LEM) 5 mg (SUV-combination cohort)|"Pretreatment phase: Continue pre-registration treatment (SUV and BZRA combination therapy) without LEM.
~First treatment phase: Administer LEM 5 mg/day as a substitute for SUV and continue BZRA. Increasing to LEM dose to 10 mg/day is allowed.
~Maintenance phase: Succeed the treatment of the first treatment phase. Changing LEM dose is allowed. Decreasing dose or discontinuation of BZRA is allowed. Rescue administration of Z-drug or RMT is allowed under a defined condition."
15764337|NCT04741906|Procedure|Prosthetic treatment|Prosthetic treatment and loading of the dental implants
15764244|NCT04742686|Other|Aerobic exercise training|5-day, power-assisted, low- to moderate-intensity, aerobic exercise training programme. Exercise duration to progress from 10 minutes on day 1, to 30 minutes on day 5. Exercise equipment: Letto-2 (Motomed, Germany).
15764245|NCT04742673|Drug|Guanfacine|Patients randomized to the IV Guanfacine arm will receive intravenous guanfacine when they exhibit ICU delirium.
15764246|NCT04742673|Drug|Placebo|Patients randomized to the placebo arm will receive intravenous normal saline when they exhibit ICU delirium.
15764247|NCT04742660|Drug|Ammonium Glycyrrhizinate|In control group, we assess the incidence and severity of PONV when participants are aministered ramosetron and placebo. In intervention group, the outcomes are assessed as a result of administration of ramosetron and glycyrrhizin.
15764248|NCT04742647|Procedure|Double cerclage|Two cervical cerlages will be placed
15764249|NCT04742647|Procedure|Single cerclage|One cerclage will be placed
15764250|NCT04742634|Drug|DEC-C|"DEC-C will be provided by Taiho Pharmaceuticals.
~Cycle 1 Day 1 may take place between Day 42 & Day 100 post-transplant."
15764251|NCT04742634|Device|MyeloSeq-HD|-Laboratory test developed at Washington University School of Medicine
15764252|NCT04742621|Procedure|Liver transplant|Eligibility for liver transplantation will be limited to patients with histologically confirmed metastatic colorectal adenocarcinoma who have achieved stability of liver metastasis on chemotherapy for at least 6 months prior to transplantation. All patients who undergo liver transplantation will start immunosuppressive therapy per protocol. Patients who undergo a successful liver transplant will not receive adjuvant therapy.
15764253|NCT04742608|Procedure|Biospecimen Collection|Undergo collection of blood and tissue samples
15764254|NCT04742608|Other|Electronic Health Record Review|Medical charts are reviewed
15764255|NCT04742595|Biological|SARS-CoV-2 Antigen-specific Cytotoxic T-lymphocytes|Given IV
15764256|NCT04742582|Dietary Supplement|Preterm Infants - fed fermented formula|Feeding infants with fermented formula supplemented with the fermentation products of the probiotic L. paracasei CBA L74 (800 mg / 100 ml of milk) (84 kcal and 2.9 g protein per 100 ml)
15764257|NCT04742582|Other|Preterm Infants - fed standard formula|Feeding infants with standard formula with the addition of skimmed milk powder in order to provide the same protein and energy amount of the supplemented formula (84 kcal and 2.9 g protein per 100 ml)
15764258|NCT04742582|Other|Pre-term Infants - breastfed|Breastfeeding infants - Reference group
15764259|NCT04742556|Drug|BI 3011441|BI 3011441 in different doses
15764260|NCT04742543|Device|SootheVR: AppliedVR, Los Angeles, California a head-mounted display|"For the study group, virtual reality content will be shown to the participant for the duration of the conization procedure through a head-mounted display, RelieVRTM. The default VR content for the trial will be swimming with dolphins or any other content chosen by the participant"
15764261|NCT04742530|Behavioral|Fasted Evening Exercise|A 45 minute exercise session will take place on a stationary cycle ergometer at 18:30, after a 7-hour period of fasting. This will consist of 30 minutes of steady state cycling at 60% of VO2max, followed by an exercise test during which participants will complete as much work as they can within 15 minutes.
15764262|NCT04742530|Behavioral|Fed Evening Exercise|A 45 minute exercise session will take place on a stationary cycle ergometer at 18:30, after having consumed a carbohydrate-containing meal (20% estimated energy requirements) 2 hours prior. This will consist of 30 minutes of steady state cycling at 60% of VO2max, followed by an exercise test during which participants will complete as much work as they can within 15 minutes.
15764263|NCT04742530|Behavioral|Fed Morning Exercise|A 45 minute exercise session will take place on a stationary cycle ergometer at 10:30, after having consumed a carbohydrate-containing meal (20% estimated energy requirements) 2 hours prior. This will consist of 30 minutes of steady state cycling at 60% of VO2max, followed by an exercise test during which participants will complete as much work as they can within 15 minutes.
15764264|NCT04742517|Drug|ASP1128|Intravenous
15764265|NCT04742517|Drug|Placebo|Intravenous
15764266|NCT04742504|Biological|BENRALIZUMAB|The decision of the patients treatment with benralizumab (Fasenra®, Astra Zeneca) included in the study will not come in any case influenced by their participation in the study but will be made in accordance with the clinical criteria established by the Asthma Multidisciplinary Unit (UMA).
15764267|NCT04742491|Drug|Immediate Intervention Arm Truvada in the US|Truvada in the United States
15764268|NCT04742491|Drug|Deferred Intervention Arm Truvada in the US|Truvada in the United States
15764269|NCT04742491|Drug|Immediate Intervention Arm Truvada in Brazil|Truvada in Brazil
15764270|NCT04742491|Drug|Deferred Intervention Arm Truvada in Brazil|Truvada in Brazil
15764271|NCT04742491|Drug|Immediate Intervention Arm Descovy in the US|Descovy in the United States
15764272|NCT04742491|Drug|Deferred Intervention Arm Descovy in the US|Descovy in the United States
15764273|NCT04742478|Procedure|Rotational Atherectomy|Rotational atherectomy (RA) has been the most used atherectomy modality since its first inception in1988. RA uses high speed rotation (140,000 - 180,000 rpm) to ablate inelastic plaque, resulting in debris averaging 5µm in size24. The main focus of RA in the era of DES stent has been on plaque modification rather that plaque debulking with more papers showing improved PCI success rates.
15764274|NCT04742465|Other|Augmented reality technological assistance for the movements of people with Alzheimer's disease or MCI in a controlled environment.|"Augmented reality technological assistance for the movements of people with Alzheimer's disease or MCI in a controlled environment.
~The ARIADE project will take place in a controlled and reproducible ecological environment (Ker Lann gymnasium) and will aim at assessing the effectiveness of Augmented Reality assistance, that of the devices for detecting wandering, the safety of the patient when traveling with an Augmented Reality headset, and his acceptance of the device.
~Three routes each comprising seven intersections, i.e. a location requiring a decision on navigation, will allow us in 20 patients to objectively compare the three different visual aids offered in augmented reality, i.e. arrows, light path, animated companion."
15764275|NCT04742452|Procedure|Superior Capusular Reconstruction|Superior capsular reconstruction is one treatment option for massive and irreparable rotator cuff tears. The superior shoulder capsule, a thin membranous structure located on the inferior surface of the supraspinatus and infraspinatus muscles, is often torn in this type of rotator cuff tear. In superior capsular reconstruction, this structure is reconstructed with acellular dermal allograft.
15834231|NCT04170738|Drug|Adderall|3 weeks of Adderall
15764276|NCT04742452|Procedure|Partial Rotator Cuff Repair|Partial rotator cuff repair can be performed, in conjunction with other procedures such as subacromial decompression and biceps tenodesis, when a rotator cuff tear is not amenable to a complete repair.
15764277|NCT04742439|Device|Sham transcranial direct current stimulation|Participants will receive 30 seconds of ramp up and down stimulation at the start and end of the 20 minute stimulation period.
15764278|NCT04742439|Device|Individualized transcranial direct current stimulation|Participants will receive 20 minutes of transcranial direct current stimulation (tDCS) at the individualized dose (maximum of 4mA).
15764279|NCT04742439|Device|2mA transcranial direct current stimulation|Participants will receive 20 minutes of transcranial direct current stimulation (tDCS) at a 2mA dose.
15764280|NCT04742439|Device|4mA transcranial direct current stimulation|Participants will receive 20 minutes of transcranial direct current stimulation (tDCS) at a 4mA dose.
15764281|NCT04742426|Other|WHO recommended PPE|Uses polycarbonate safety spectacles, fluid-resistant (Type IIR) surgical mask and disposable surgical gown. No head or foot cover.
15764282|NCT04742426|Other|Super-safe setup|Uses surgical cap, FFP3 respirator covered by surgical mask, face shield, whole-body suit (Tyvec), 3 pairs of gloves typed to suit sleeves and disposable foot cover.
15764284|NCT04742374|Biological|Blood sampling|Blood sampling before and after each type of cycle, Single Plasma Exchange or Double Filtration Plasmapheresis
15764286|NCT04742348|Drug|Carbidopa Levodopa|Participants who are randomized to active drug group will receive 1 dose of immediate release carbidopa-levodopa (50mg/500mg) .
15764287|NCT04742348|Drug|Placebo|Participants who are randomized to placebo group will be provided with similar looking tablet(s) as the active drug.
15764288|NCT04742335|Other|Survey|Survey will be applied to the participants.
15764289|NCT04742322|Dietary Supplement|Bifidobacterium Lactis CCT7858|Probiotic B Lactis
15764290|NCT04742322|Dietary Supplement|Maltodextrin|Maltodextrin
15764291|NCT04742309|Drug|Pecs-2 block (single injection)|For Pecs-2 blocks, the needle will be advanced to the tissue plane between the pectoralis major and minor muscles at the vicinity of the pectoral branch of the acromiothoracic artery where 10 mL of local anesthetic will be deposited. In a similar manner, 20 mL will be deposited at the level of the third rib above the serratus anterior muscle with the intent of spreading injectate to the axilla. The study fluid will be ropivacaine 0.3% with epinephrine.
15764292|NCT04742309|Drug|Paravertebral block (single injection)|For paravertebral blocks, ropivacaine 0.5% (with epinephrine) 9 mL will be administered at each of two levels per side: the T3 and T5 levels for sides without axillary involvement; and at the T2 and T4 level for sides with axillary involvement.
15764293|NCT04742296|Device|low level laser therapy|We will use laser light that has continuous wave mode, power of 100 mW, energy density of 7,5 joule/cm2, treatment time as 300 seconds.
15764294|NCT04742283|Drug|DE-126 Ophthalmic Solution 0.002% QD|DE-126 Ophthalmic Solution QD evening and Vehicle QD Morning
15764295|NCT04742283|Drug|Timolol Maleate Ophthalmic Solution 0.5% BID|Timolol Maleate Ophthalmic Solution BID (morning and evening)
15764296|NCT04742270|Device|SIMEOX+ respiratory physiotherapy telecare|"Every 10 days, the patient's expert physiotherapist will contact the patient by video-transmission or telephone call for motivational reinforcement and technical support in the use of the device.
~During these phone calls, a quick 3-question questionnaire will be administered to the patient to monitor events of hemoptysis, chest pain and clinical symptoms of gastroesophageal reflux disease: pyrosis.If patients report this type of event, the physiotherapist will inform the patient's physician for management at his/her discretion.
~The expert physiotherapist will also conduct this sessions in order to increase the patient's motivation and compliance to the device. In order to do this, he will identify (in collaboration with the patient), the patient's difficulties and obstacles and he will try to find solutions with him."
15764297|NCT04742257|Device|MyoRegulator® device|Trans-spinal DCS paired with peripheral DCS
15764298|NCT04742244|Dietary Supplement|Lvemon verbena extract|Each capsule contained 200 mg of lemon verbena extract 2 capsules/day, 14 days
15764299|NCT04742244|Dietary Supplement|maltodextrin|Each capsule contained 0 mg of lemon verbena extract 2 capsules/day, 14 days
15764300|NCT04742231|Device|Hand-held dynamometer|Maximum Grip Strength will be measured using a hand-held dynamometer (K-FORCE Grip dynamometer®. Kinvent Biomequanique S.A.S, Montpellier, France) during the preoperative, intraoperative (Awake craniotomy) and postoperative period.
15764301|NCT04742218|Drug|K-877|K-877 Tablet
15764302|NCT04742205|Drug|Tranexamic Acid 500 MG|Loading dose of trial (1g of tranexamic acid in 10ml) is mixed in 100ml sodium chloride 0.9% and given over 10 minutes. Maintenance dose of trial mixed in 500ml sodium chloride 0.9% is given over 8 hours
15764303|NCT04742179|Other|Manteinance and care intervention on the green areas.|Manteinance and care intervention on the green areas.
15764304|NCT04742166|Procedure|Reconstruction|Lateral gastrojejunal Terminolateral gastrojejunal
15764305|NCT04742153|Drug|MRG002|Administrated intravenously
15764306|NCT04742140|Drug|Magnesium sulfate|each patient injected 0.5ml in each TrPs of magnesium sulphate according to the treatment group by the same operator
15764307|NCT04742140|Drug|Saline|each patient injected 0.5ml in each TrPs of saline according to the treatment group by the same operator
15764308|NCT04742127|Diagnostic Test|Single surgical debridement|To describe the clinical factors associated with failure of a single surgical debridement in patients with septic arthritis of the native hip.
15764309|NCT04742114|Device|use the face mask with Expiratory Positive Airway Pressure(EPAP).|The subjects were divided into two groups. The first group use the face mask without EPAP, and the other group use the face mask with EPAP.
15764310|NCT04742114|Device|use the face mask without Expiratory Positive Airway Pressure(EPAP).|The subjects were divided into two groups. The first group use the face mask without EPAP, and the other group use the face mask with EPAP.
15764311|NCT04742101|Drug|S65487 and azacitidine|Treatment cycle of combination of S65487 and azacitidine during 4 weeks. S65487 will be administered via intravenous (IV) infusion. Azacitidine will be administered via either subcutaneous (SC) or Intravenous (IV) infusion according to local practices.
15764338|NCT04741893|Device|EndoFLIP|Use of Endoluminal Functional Lumen Imaging Probe to assess anal canal function
15764312|NCT04742088|Device|ankleSOFT100|During the first two weeks of follow-up, the subject shall not use the device during the sports sessions. The subject shall use the device during the sports sessions for the next 4 weeks (6 weeks of follow-up)
15764313|NCT04742075|Drug|Olaparib + durvalumab + UV1|The subjects are randomized 1:1:2 to receive treatment until progression of disease or untorable toxicity.
15764314|NCT04742062|Drug|ApTOLL|ApTOLL is a Toll-like receptor 4 (TLR4) antagonist, a receptor that is involved in innate immune responses but also responds to tissue damage, and therefore it is directly involved in a large number of diseases where the inflammatoryy response is involved. ApTOLL has demonstrated specific binding to human TLR4 as well as a TLR4 antagonistic effect, reducing inflammation and improving outcome after different disease models.
15764315|NCT04742062|Other|Placebo|100 mL 0.9% Sodium Chloride solution
15764316|NCT04742049|Other|Telerehabilitation-based|15 pediatric cystic fibrosis patients who are at home during the self- isolation process due to the COVID-19 pandemic will be included in this group. Online exercise training protocol will be apply for patients. Each training protocol was planned as 30 minutes for 3 days a week for 6 weeks with a physiotherapist. Exercise protocol will start with the warm-up exercises and finish with cooling exercises.
15764317|NCT04742049|Other|Follow-up based|15 pediatric cystic fibrosis patients who are at home during the self- isolation process due to the COVID-19 pandemic will be included in this group. An exercise document including the same exercise protocol in study group will be sent the patients. Patients will be called by the physiotherapist once a week for follow-up. .
15764318|NCT04742036|Drug|Capivasertib|Part A Cycle 0: Single dose 480 mg(3 x 160 mg tablets) on Day 1 of Cycle 0 Cycle 1 (monotherapy): 480 mg(3 x 160 mg tablets) twice daily given on an intermittent weekly dosing schedule (4 days on, 3 days off for 7 days) Part B Cycle 2 (in combination therapy with paclitaxel): 400 mg (2 x 200 mg tablets) twice daily given on an intermittent weekly dosing schedule. Patients will be dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week off-treatment within each 28-day treatment cycle. Capivasertib treatment will continue until disease progression, unacceptable toxicity or the participant requests to stop treatment.
15764319|NCT04742036|Drug|Paclitaxel|"Part B Cycle 2: Patients will receive 3 consecutive weekly infusions of 80 mg/m2 (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle.
~Paclitaxel treatment will continue for at least 6 cycles, unless the participant experiences unacceptable toxicity that is attributed directly to treatment with paclitaxel, or disease progression."
15764320|NCT04742023|Device|Continuous Glucose Monitor Application|The Guardian™ Sensor glucose sensor is part of the Medtronic Continuous Glucose Monitoring (CGM) system. The system then uses these signals to provide sensor glucose values. Patients post-renal transplantation will have CGMs applied and values interpreted by nursing.
15764321|NCT04742023|Diagnostic Test|Finger Stick Glucose Measurement|Patients post-renal transplant will have finger-stick glucose measurements checked prior to meals.
15764322|NCT04742023|Drug|Insulin|Insulin will be administered.
15764323|NCT04742023|Device|Continuous Glucose Monitor Placebo Applied|The Guardian™ Sensor glucose sensor is part of the Medtronic Continuous Glucose Monitoring (CGM) system. The system then uses these signals to provide sensor glucose values. Patients post-renal transplantation will have CGMs applied however values will not be interpreted.
15764324|NCT04742010|Drug|Zoledronic Acid|"A single treatment 21 days before bariatric surgery with Zoledronic acid 5 mg or placebo
~Pharmaceutical form: Solution for infusion (100 ml normal saline containing 5 mg zoledronic acid or placebo)
~Administration: slow intravenous infusion with a duration of at least 15 minutes"
15764325|NCT04742010|Drug|Placebo|as above
15764326|NCT04741997|Drug|Encorafenib Pill|Encorafenib 450 mg will be administered orally once per day in continuous 28-day cycles
15764327|NCT04741997|Drug|Binimetinib Pill|Binimetinib 45 mg will be administered orally twice per day in continuous 28-day cycles
15764328|NCT04741997|Drug|Nivolumab|Nivolumab will be administered at a dose of 480 mg IV infusion over 30 minutes every 4 weeks.
15764329|NCT04741984|Biological|MT-201-GBM monocyte vaccine|monocytes isolated from patient's leukapheresis loaded with CMV pp65-LAMP (Lysosomal-associated Membrane Protein) mRNA (Messenger Ribonucleic Acid)
15764330|NCT04741971|Dietary Supplement|Probiotics group|Will give Probiotics with Vitamin D3 one drop per day for 90 days
15764331|NCT04741971|Dietary Supplement|Non-probiotics group|Will give Vitamin D3 five drops per day for 90 days
15764332|NCT04741958|Diagnostic Test|Ultrasound Guided Peripheral Thoracic Tumors|Transthoracic ultrasonography: Transthoracic US was done using machine Hitachi 5500 in the Diagnostic Ultrasound Unit - Chest Department- Kasr El-Aini Hospital.on 60 patients that had radiographic evidence of thoracic mass suspected of malignancy
15764333|NCT04741945|Drug|Metformin|2000mg/daily metformin for 12 months with a slow up-titration two weeks prior to full dose treatment.
15764334|NCT04741932|Other|Dementia Care Management (DCM)|"A computerized Information and Care Management System (IMS) will identify unmet nursing, medical, psychosocial and social needs of the PwD and its informal caregiver. Based on this data, the IMS generates suggestions for interventions: The DCM in cooperation with the general practitioner (GP) develops an individual treatment and care plan that is tailored to the needs of the PwD and its caregiver. The DCM will initiate the implementation of respective actions and monitor the status of implementation. Therefore, the DCMs are supposed to take on activities that were previously usually performed by doctors (redistribution of tasks between physicians and qualified nurses in primary care)."
15764335|NCT04741919|Procedure|Yag Laser peripheral Iridotomy|Laser peripheral iridotomy will be performed using neo-dynium:yttrium:aluminium-garnet laser after pretreatment with 2% pilocarpine and brimonidine 0.15%. Superior LPIs will be placed between the 11- and 1-o'clock positions such that they were covered completely by the upper eyelid; nasal/temporal LPIs will be placed between the 2- and 4-o'clock positions or the 8- and 10-o'clock positions such that they were completely clear of the lid margin. Preference will be given to iris crypts, avoiding iris vessels when possible. Laser peripheral iridotomies will be performed in both eyes during the same visit and will be confirmed to be patent after the procedure. Intraoperative data collected will include initial per-shot laser energy in milli joules, number of laser shots, and total laser energy in millijoules. All the patients will be treated with flurometholone 0.1% eye drops QID for 5 days after surgery.
15764336|NCT04741906|Procedure|Dental implant surgery|Dental surgery in cancer patients in high dose antiresorptive treatment
15764369|NCT04741646|Drug|Placebo|Placebo to match Ferric Citrate tablets
15764339|NCT04741880|Drug|Lidocaine IV|"Will be sent to Group L a 10 ml syringe of 2% lidocaine and 200 ml of lidocaine solution at 8mg.ml-1 (80ml of 2% lidocaine associated with 120ml 0.9% sodium chloride)
~A syringe with 10 ml of solution and a bag with 200 ml of solution indistinguishable between the groups, with the identification of the patient by label prepared specifically for the study will be prepared by the Pharmacy personal. The bag and the solution will be sealed in a waterproof and opaque envelope and sent to the Operating Theatre (OT). The envelope will be stored in the refrigerator of the sector between 3º C and 8º C until the patient is sent to the operating room, when the drugs will be sent to the operating room. At the time designated for the start of the intervention, a bolus of 0.075 ml.kg-1 of the syringe solution, followed by 0.25 ml.kg-1.h-1 in the infusion pump of the solution in the bag will be administered."
15764340|NCT04741880|Drug|Saline|"Group S will be sent a 10 ml syringe of 1% lidocaine and 200 ml of saline solution (0.9% sodium chloride)
~A syringe with 10 ml of solution and a bag with 200 ml of solution indistinguishable between the groups, with the identification of the patient by label prepared specifically for the study will be prepared by the Pharmacy personal. The bag and the solution will be sealed in a waterproof and opaque envelope and sent to the Operating Theatre (OT). The envelope will be stored in the refrigerator of the sector between 3º C and 8º C until the patient is sent to the operating room, when the drugs will be sent to the operating room. At the time designated for the start of the intervention, a bolus of 0.075 ml.kg-1 of the syringe solution, followed by 0.25 ml.kg-1.h-1 in the infusion pump of the solution in the bag will be administered."
15764341|NCT04741867|Other|Education|Patients will be educated to determine their level of coping with stress and their adaptation.
15764342|NCT04741854|Device|Positive Airway Pressure (PAP) Therapy|PAP therapy supplies pressurized air from the flow generator to the upper airway via air tubing and a mask to prevent the repetitive collapse of the upper airway during sleep.
15764343|NCT04741841|Dietary Supplement|GutMagnific™ H.|Vegan Capsules with active product, GutMagnific™ high dose
15764344|NCT04741841|Dietary Supplement|GutMagnific™ L.|Vegan Capsules with active product, GutMagnific™ low dose
15764345|NCT04741841|Dietary Supplement|Placebo|Vegan capsules identical to active product in taste and appearance but without probiotic
15764346|NCT04741828|Drug|Vi-DT Typhoid Conjugate Vaccine|Typhoid Conjugate Vaccine
15764347|NCT04741815|Device|Forced Air Warming|It consists of the WarmAir® unit and FilteredFlo® blankets. FilteredFlo® blankets are a cover designed to cover the entire body and extremities with air channels that provide the appropriate distribution of patient warm. The WarmAir® warming device connected to the shroud via a pipe; it has three temperature settings, 32.2 C, 37.8 C, and 43.3 C.
15764348|NCT04741815|Device|Peripheral Carbon Fiber Warming|It was developed by the researcher. Designed as gloves and socks, these warming materials have three layers. The first layer in contact with the patient and the third layer in contact with the external environment is a thermal material to maintain body temperature. The second floor consists of a USB-connected carbon fiber warmer and foil.
15764350|NCT04741789|Drug|Capmatinib|Tablet for oral use, dose Up to 400mg, twice daily
15764351|NCT04741776|Behavioral|Resilience Enhancement Skills Training|Family therapy
15764352|NCT04741776|Behavioral|Problem-Solving Individual Therapy|Individual therapy
15764353|NCT04741763|Dietary Supplement|EyePromise Visual Edge|A dietary eye supplement containing 8 mg zeaxanthin and 4 mg lutein and additional proprietary nutrients
15764354|NCT04741750|Other|Simplified HCV care within a mobile medical unit|Delivers guideline-based care for HCV in a stream-lined manner on a mobile medical unit
15764355|NCT04741737|Procedure|reSLNB arm|Radioisotope, blue dye, dual mapping methods are all allowed for re-SLNB mapping. Positive finding in re-SLNB is defined according to AJCC 8th edition, as micrometastasis or macrometastasis. Isolated tumor cell is considered negative. When sentinel lymph node is not identified, axillary operation is via physician's choice. When re-SLNB finding is negative, no further axillary lymph node dissection is performed. If there is node metastasis from re-SLNB, axillary lymph node dissection or radiation therapy can be performed as in physician's choice.
15764356|NCT04741724|Device|TEDS|An non-invasive intervention. During the intervention, the electrode was placed on the skin stimulated muscle.
15764357|NCT04741711|Procedure|An ultrasound (lung and inferior vena cava) will be performed and the heart failure treatments will be guided by the results of the lung ultrasound and the evaluation of the inferior vena cava.|An ultrasound (lung and inferior vena cava) will be performed and the heart failure treatments will be guided by the results of the lung ultrasound and the evaluation of the inferior vena cava. The choice of congestion treatment modalities to be implemented is left to the investigators' discretion, in accordance with European practice guidelines.
15764358|NCT04741711|Procedure|Usual care without ultrasound guidance|Usual care (i.e. without ultrasound guidance)
15764359|NCT04741698|Drug|Propranolol|Propranolol 2mg IV
15764360|NCT04741685|Device|TTSX2|Treatment with Tandem T Slim X2 with Basal IQ
15764361|NCT04741685|Device|MM640G|Treatment with Medtronic Minimed 640G with Smartguard
15764362|NCT04741672|Behavioral|Providing guidance after discharge routine procedure and calling one week after discharge.|Guidance will be given to mothers after routine discharge. After one week, she will be called by phone and her questions about infant care will be answered.
15764363|NCT04741672|Behavioral|Discharge routine procedure.|Discharge routine procedure.
15764364|NCT04741659|Device|Ventimask|The patients will be asked to breathe spontaneously using their actual low oxygen flow
15764365|NCT04741659|Device|High Flow Nasal cannula (HFNC)|The patients will be asked to breathe using high flow nasal cannula (HFNC). Air flow will set up to 60 l/m, temperature according to patient's comfort and FiO2 in order to obtain SpO2 values >/= 92%
15764366|NCT04741659|Device|Helmet CPAP|The patients will be asked to breathe with Helmet. CPAP will set at 10 cmH2O and FiO2 in order to obtain SpO2 values >/= 92%
15764367|NCT04741659|Device|Non Invasive Ventilation (NIV)|the patients will be asked to breathe with the support of a ventilator via a oro-nasal interface
15764368|NCT04741646|Drug|Ferric Citrate|Auryxia® 210 mg ferric iron tablets equivalent to 1 g of FC and matching placebo will be supplied as 200 tablets in 400cc high-density polyethylene bottles.
15764370|NCT04741620|Other|Capsaicin 10microM (TRPV1 natural agonist)|10 mL Capsaicin 10microM solution 3 times per day (before each meal) during 14 consecutive days.
15764371|NCT04741620|Other|Piperine 150microM (TRPV1 & TRPA1 natural agonist)|10 mL Piperine 150microM solution 3 times per day (before each meal) during 14 consecutive days.
15764372|NCT04741620|Other|Cinnamaldehyde 756,6microM + zinc 70microM (TRPA1 natural agonist)|10 mL Cinnamaldehyde 756,6microM + zinc 70microM solution 3 times per day (before each meal) during 14 consecutive days.
15764373|NCT04741620|Other|Citric acid 457,5microM (pH=3,5) (ASIC3 natural agonist)|10 mL Citric acid 457,5microM (pH=3,5) solution 3 times per day (before each meal) during 14 consecutive days.
15764374|NCT04741620|Other|Capsaicin 10microM + Citric acid 457,5microM (pH=3,5) (TRPV1 & ASIC3 natural agonists)|10 mL Capsaicin 10microM + Citric acid 457,5microM (pH=3,5) solution 3 times per day (before each meal) during 14 consecutive days.
15764375|NCT04741620|Other|Placebo (Methyl benzoate, Propyl benzoate, Propylenglycol)|10 mL placebo solution 3 times per day (before each meal) during 14 consecutive days.
15764376|NCT04741607|Device|Implant placement (BLX implant system, Straumann, Basel, Switzerland)|Implants are placed after a healing period of 4 months (delayed implant placement, control group) or immediately after tooth extraction and ridge preservation (immediate implant placement, test group).
15764377|NCT04741607|Procedure|Ridge preservation (Bio-Oss Collagen 250 mg, Geistlich Pharma AG, Wolhusen, Switserland)|Ridge preservation is performed by inserting a collagen-enriched DBBM (Bio-Oss Collagen 250 mg, Geistlich Pharma AG, Wolhusen, Switserland) in the empty extraction socket (delayed implant placement, control group) or by filling the gap between the implant and buccal bone wall (immediate implant placement, test group).
15764378|NCT04741607|Procedure|Socket seal (Mucograft Seal, Geistlich Pharma AG, Wolhusen, Switserland)|The occlusal aspect of the grafted socket in the delayed implant placement/control group is closed with a collagen matrix.
15764379|NCT04741594|Device|Densah|Alveolar bone remodeling after tooth extraction may result in significant ridge resorption and inadequate bone volume for implant placement. Several methods have been designed for ridge augmentation, among which is the new technique of osseodensification, using the Densah® burs by Versah® (Versah®, LLC, Jackson, MI, USA). This method compresses the trabecular bone to periphery of the osteotomy site and has shown up to 80% ridge expansion in animal histological studies , , , , , . Apart from being an animal model with a short follow-up, another limitation of these studies is the lack of three-dimensional evaluation of the change in morphology of the ridge. Human clinical studies , , , , have reported similar results, but they do not evaluate if this bone volume is retained during osseointegration and loading periods. No standardization method or long-term evaluation of peri-implant health was reported.
15764380|NCT04741581|Dietary Supplement|ThickenUp® Gel Express|Thickening gel
15764381|NCT04741568|Behavioral|Parental psychoeducational Intervention|"The psychoeducation intervention for parents will focus on providing skills, knowledge and support motivation for caregivers of children with diabetes.
~A brief (one-day or two half days) workshop, and a website with downloadable content will be made available to review and refresh any skills and techniques."
15764382|NCT04741542|Drug|SP-420|This study aims to establish the safety of SP-420 administered orally three times per week (TIW).
15764383|NCT04741529|Behavioral|Healthy Minds Program app|"The HMP app was developed by Healthy Minds Innovations at the UW Center for Healthy Minds, and is based on the work of Drs. Richard Davidson and Cortland Dahl. HMP is designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of high-quality guided practices. HMP is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). HMP has >100 guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose.
~Participants in this study will receive 2 weeks of training in the Connection module of HMP."
15764384|NCT04741516|Drug|Foquest|The drug being evaluated in this study is controlled release methylphenidate HCl control (Foquest®). Foquest® is a novel formulation of MPH developed by Purdue Pharma (Canada) and is approved in Canada for the treatment of ADHD in patients six years of age and older. Foquest® is the first methylphenidate product approved in Canada with an onset of action within one hour and a duration of action up to and including 16 hours (Wigal et al.2016). Foquest® is an ADHD treatment option for patients who require a rapid onset of action and extended duration of action
15764385|NCT04741503|Other|Breast Cancer Screening Decision Support Tool|-Provides a description of screening mammography, current screening recommendations, benefits and downsides, narratives, and questions for the participant's physician.
15764386|NCT04741503|Other|National Cancer Institute Breast Cancer Screening PDQ|-Provides current information about breast cancer screening and is meant to inform and help patients
15764387|NCT04741490|Drug|Camrelizumab|PD-1antibodies，200mg ivgtt Q3W
15764388|NCT04741490|Radiation|radiotherapy|45-55Gy/1.8～2.0Gy
15764389|NCT04741477|Drug|CBD|CBD will be topically applied
15764390|NCT04741477|Drug|THC|THC will be topically applied
15764391|NCT04741477|Drug|Placebo|a placebo product (without cannabinoids) will be topically applied
15764392|NCT04741464|Drug|Tinzaparin|"Tinzaparin 20 000 anti-Xa IU/mL dispensed in graduated syringes of 0.5 mL, 0.7 mL and 0.9 mL at the dose of 175IU/Kg/d.
~Strategy: Tinzaparin 175 UI/Kg/d for 21 days After this time the physician will continue the treatment of his choice to treat DVT."
15764393|NCT04741438|Drug|Nivolumab and IPILIMUMAB|"The combination of Nivolumab+Ipilimumab will be given to patients as follows:
~Nivolumab: 3 mg/kg IV over 30 minutes every 2 weeks for 4 cycles.
~Ipilimumab 1 mg/kg IV over 60 minutes every 6 weeks for 4 cycles. After completion of 4 courses with ipilimumab, patients continue receiving nivolumab IV at the dose of 480 mg Q4W in the absence of disease progression or unacceptable toxicity for a maximum of 6 months.
~Nota Bene: A cycle is defined as a 6-weeks period.
~The planned treatment period is12 months
~Nivolumab and Ipilimumab must be injected the same day every 6 weeks (Q6W). In case of toxicity, dose will be delayed, but will not be reduced."
15764394|NCT04741438|Drug|Pazopanib Oral Tablet [Votrient]|"Treatment by pazopanib 800 mg/day per os, continuously during a maximum 12 months.
~In case of toxicity, dose will be delayed and reduced."
15764426|NCT04741087|Drug|AMT-101 (oral)-Dose B|AMT-101 is an orally administered biologic therapeutic, taken once daily.
15764395|NCT04741425|Other|REST intervention|"The breastfeeding talk will be conducted by Zoom at the third trimester about breastfeeding benefits and other practical advices. There is also a sharing session by a successful breastfeeding mother and a group discussion with different breastfeeding scenarios.
~Once the mothers return home after delivery, individualized breastfeeding coaching will be provided by PI through a daily Zoom videoconference within 24 hours upon hospital discharge till Day 7 after delivery.
~During the last breastfeeding videoconference, mothers will be reminded to have weekly telephone follow-ups by PI from week 2 to 2 months postpartum.
~Women who are randomised into the intervention group will receive REST in addition to the standard antenatal and postnatal care (described at below) by the Obstetrics Department of their delivery hospitals."
15764396|NCT04741386|Biological|SARS-CoV-2 vaccination|All participants will receive two vaccinations against COVID-19 according to the manufacturer's instructions.
15764397|NCT04741373|Dietary Supplement|oral nutritional supplements|oral nutritional supplements, 400-600kcal/day;
15764398|NCT04741373|Behavioral|rehabilitation exercise|Aerobic exercise: fixed cycling in rehabilitation center or walking at home, 3-5 times/week, Resistance exercise: lift dumbbell by upper limb, raise legs tying sandbags, 2-3 times/week
15764399|NCT04741373|Other|health education|Establish WeChat group or QQ group or telephone contact, and regularly distribute electronic science pictures or small videos
15764400|NCT04741360|Other|Modified Story Memory Technique|10-session computerized program to improve new learning and memory
15764401|NCT04741334|Drug|direct anticoagulant|exposure to direct anticoagulant
15764402|NCT04741334|Drug|antiplatelet drugs|exposure to antiplatelet drugs
15764403|NCT04741334|Drug|Dicumarolics|exposure to dicumarolics
15764404|NCT04741321|Other|VascuQol-6 questionnaire Spanish version|VascuQol-6 questionnaire was translated by two professional translators into Spanish.
15764405|NCT04741308|Behavioral|cognitive behavior therapy|The CBT intervention is a 10-times group-based intervention that meets monthly for 1.5 hours. Our CBT intervention is designed to be conducted in groups of six to eight patients led by two group facilitators. The first session will be done a week before surgery, and the next nine sessions will be done a week before chemical therapy. Group leaders will: guide participants relaxation training, develop a supportive group environment, encourage emotional expression, assist participants develop a sense of self-confidence, identify maladaptive coping and encourage adaptive coping responses.
15764406|NCT04741295|Drug|Low molecular weight heparin|Patients with adenomyosis were treated with low molecular weight heparin after frozen embryo transfer in addition to routine luteal support.
15764407|NCT04741282|Other|Pulmonary telerehabilitation|pulmonary telerehabilitation program include breathing exercise,aerobics exercise and upper and lower limbs muscle strengthening exercise
15764408|NCT04741282|Other|progressive muscle relaxation training|summarized Jacobson progressive muscle relaxation training method
15764409|NCT04741269|Diagnostic Test|Find a link between lack of knee flexion and meniscal posterior luxation fixed|"Measure the full flexion angle of the knee using a goniometer. Measure the heel-buttom distance. All measurements are carried out in bilateral and comparative ways.
~Search for the meniscal position on MRI and intraoperatively: no shift, anterior, medial, posterior shift."
15764410|NCT04741256|Behavioral|Education booklet & standardized discharge training|Tracheostomy education booklet and tracheostomy teaching performed by nurses during hospitalization as dictated by the booklet.
15764411|NCT04741243|Device|Extracorporeal Shock wave|Dietary modifications are changes made during food preparation, processing, and consumption to increase the bioavailability of micronutrients-and reduce micronutrient deficiencies-in food at the commercial or individual/household level
15764412|NCT04741230|Device|Gebauer Lenticule|The Gebauer™ Lenticule corneal implant device is a custom-made device intended for patients suffering from keratoconus or post-LASIK ectasia. The device is expected to reinforce and stabilize the patient's cornea, so that a more consistent refraction is induced and a penetrating human cornea donor transplantation may be avoided or postponed.
15764413|NCT04741217|Other|Not an interventional study|No interventions are implemented. This is an observational study of respiratory droplet aerosolisation during respiratory procedures.
15764414|NCT04741204|Drug|Metformin Extended Release Oral Tablet|initial dose of metformin of 750 mg Q.D. (with dinner) for 3-4 weeks. They then will be increased to the final dose of 750 mg BID (breakfast and dinner) until the end of the study.
15764415|NCT04741191|Other|Cycle ergometer training|Hospital-based ergometer cycling for 20 minutes (Including warm-up and cooldown), 3x/week on alternate days for 6 weeks at 40-60% of VO2max.
15764416|NCT04741191|Other|Conventional therapy|In bed activities (Active ankle and hand pumping exercise* 15 Rep* BD AROMS of extremities* 15 Rep* BD, Deep breathing exercises* 15 Rep* BD, Ambulation (walk 10-15 minutes below fatigue and onset of symptoms level* BD) for 6 weeks.
15764417|NCT04741165|Drug|HX008|200 mg administered as IV infusion on Day 1 of each 21-day cycle.
15764418|NCT04741165|Drug|Bevacizumab|15 mg/kg administered as IV infusion on Day 1 of each 21-day cycle.
15764419|NCT04741165|Drug|Lenvatinib|Administered orally once a day during each 21-day cycle
15764420|NCT04741152|Procedure|Pancreatic resection|Different pancreatic resections
15764422|NCT04741126|Other|Manually assisted cough technique|Manually assisted cough technique will be given for four weeks. 10 to 12 repetitions of manually assisted cough technique with rest will be given in one minute 3 to 4 time of repetition in a 1 set. The result of the peak cough flow meter and incentive spirometer will be check pre and post only.3 sets will be given in one session and 2-time session will be recommended per day. The session will be given three days in a week. The Result of the Peak Cough flow meter and incentive spirometer will be check pre and post only.
15764423|NCT04741113|Other|An online 15-minute educational module|"An online 15-minute educational module with four sections: a) Knowledge about obesity; b) Weight bias definition and impact; c) Strategies to reduce weight bias; d) A short quiz.
~The module will be based on relevant literature and expert opinion"
15764424|NCT04741100|Other|Ex-vivo analysis|Ex-vivo analysis
15764425|NCT04741087|Drug|AMT-101 (oral)-Dose A|AMT-101 is an orally administered biologic therapeutic, taken once daily.
15764427|NCT04741074|Drug|Semaglutide 2 mg/1.5 ml (1.34 mg/ml), prefilled pen-injector for subcutaneous injection solution|Dose will be started at 0.25 mg per week. Dose escalation will occur every 4 weeks to mitigate risk of gastrointestinal side effects to a maximum dose of 1.0 mg per week.
15764428|NCT04741074|Drug|Placebo 1.5 ml, prefilled pen-injector for subcutaneous injection solution|Matched placebo solution for injection will be provided by Novo Nordisk in a 1.5 ml pre-filled pen-injector for subcutaneous injection with the same instructions on dose escalation.
15764429|NCT04741061|Biological|Sputnik Light|"Sputnik-Light vector vaccine:
~Active substance: recombinant adenovirus serotype 26 particles containing the SARS-CoV-2 protein S gene, in the amount of (1.0±0.5) х 1011 particles per dose."
15764430|NCT04741061|Other|Placebo|Placebo
15764431|NCT04741048|Device|CI624 Slim 20 Electrode|Cochlear Ltd CI624 cochlear implant with Slim 20 Electrode
15764432|NCT04741035|Other|Modified sternal precautions|"Use pain and discomfort to guide the safe use of the arms Avoid pushing or pulling with one arm Use both arms close to the body during lifting Use of arms is possible, but keep them close to the body Avoid stretching one or both arms backwards at the same time Use a cushion or perform sternal preservation technique (crossing the arms in a 'self-hugging 'posture) when coughing.
~When transferring, roll onto the side, ease the legs over the edge of the bed and carefully use the arms to sit up from a lying position"
15764433|NCT04741035|Other|Conventional sternal precautions|Avoid pushing or pulling through the arms Avoid one-arm (unilateral) activity Limit the elevation of the arms to 90 degrees Avoid lifting objects heavier than 2 kg Use a cushion or perform sternal preservation technique (crossing the arms in a 'self-hugging' posture) when coughing Limit the use of the arms when transferring from sitting to standing and getting out of bed Avoid placing the arms behind the back
15764434|NCT04741009|Device|CI632 Slim Modiolar Electrode|Cochlear Ltd CI632 cochlear implant with Slim Modiolar Electrode
15764435|NCT04740996|Drug|Pembrolizumab|Pembrolizumab (formerly lambrolizumab, brand name Keytruda) is a humanized antibody used in cancer immunotherapy. This includes to treat melanoma, lung cancer, head and neck cancer, Hodgkin lymphoma, and stomach cancer.
15764436|NCT04740983|Other|Heliotherapy (a sole sun-bathing)|16-week heliotherapy regimen based on the predicted anti psoriasis effective irradiance values.
15764437|NCT04740970|Drug|JNJ-64304500|JNJ-64304500 injection will be administered subcutaneously.
15764438|NCT04740970|Drug|Placebo|Matching placebo injection will be administered subcutaneously.
15764439|NCT04740957|Other|Distal limb reintroduction of ileostomy effluent|"Patients will undergo water soluble contrast enema to confirm anastomotic healing 8 weeks post operatively as per standard practice at Imperial.
~Patients will be educated in how to reintroduce ileostomy output to the distal (downstream) loop of their ileostomy. They will be asked to reintroduce 50ml of ileostomy output using a conventional long-tipped bladder syringe daily until surgery to close the stoma."
15764440|NCT04740944|Behavioral|Salutogenic Approach Based Interview|Salutogenic Approach Based Interview has five basic components. (1) Continuity of health, (2) The story of the person, (3) Health promoting factors, (4) Understanding the health promoting power of tension and strain, (5) Active adaptation In traditional therapy recommended for recovery, more emphasis is placed on negative life events, diagnosis and medication. In the salutogenic approach-based interview, the resources and coping potential of the person are discussed and three healing factors are focused on for the recovery process. These factors are that the participants (1) perceive themselves as more than just a diagnosis and disease, (2) self-discovery and respect for other people's self-discovery, (3) control over their own lives. In the intervention, mental health nurses take part as group leaders. The focus in interviews is therapeutic conversations.
15764441|NCT04740931|Drug|Faricimab|Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm.
15764442|NCT04740931|Drug|Aflibercept|Aflibercept 2 mg will be administered by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
15764443|NCT04740931|Procedure|Sham Procedure|The sham is a procedure that mimics an IVT injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
15764444|NCT04740918|Drug|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 mg/kg IV infusion
15764445|NCT04740918|Drug|Atezolizumab|Atezolizumab 1200 mg IV infusion
15764446|NCT04740918|Other|Placebo|Placebo matched to atezolizumab
15764447|NCT04740905|Drug|Faricimab|Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm.
15764448|NCT04740905|Drug|Aflibercept|Aflibercept 2 mg will be administered by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).
15764449|NCT04740905|Procedure|Sham Procedure|The sham is a procedure that mimics an intravitreal (IVT) injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
15764450|NCT04740892|Other|Wash IP|Parent participant will bathe the child participant with the investigational wash at least 3 times per week, but no more than once daily, for 4 weeks.
15764451|NCT04740892|Other|Cream IP|Parent participant will apply the investigational cream on their child participant twice daily for 4 weeks.
15764452|NCT04740879|Behavioral|Be Mindful|The online 4-week Be Mindful intervention was designed to follow the same outline as typical in-person 8-week MBCT courses. Week 1 and Week 2 introduce the topic of mindfulness and encourage its daily use, whereas Week 3 and Week 4 teach the individual to decenter from thoughts and utilize mindfulness when coping with stressors. Each week focuses on a separate mindfulness topic, which is initially presented to the individual in a short (under 5 minute) video containing didactic information and an overview of the experiential activities that will be introduced in subsequent videos. The intervention is provided entirely through audio, video, and text provided on the Be Mindful website (BeMindfulOnline.com).
15764453|NCT04740866|Radiation|Adjuvant Radiotherapy|Irradiation of both the bladder tumor bed and pelvic lymph nodes using Intensity-Modulated Radiation-Therapy (IMRT) technique. ([50Gy in 25 fractions conventional fractionation including tumor bed & pelvic lymph nodes]
15764481|NCT04740580|Dietary Supplement|Glycine|The active arm will supplement a combination of glycine and N-acetylcysteine (GlyNAC)
15764482|NCT04740580|Dietary Supplement|N-acetylcysteine|The active arm will supplement a combination of glycine and N-acetylcysteine (GlyNAC)
15764454|NCT04740853|Behavioral|Sensory Integration Therapy+Special Education|Sensory integration is a theory first put forward by Ayres in 1972. It is a neurological process that organizes sensory stimuli from our body and our environment for use in the daily life. When the sensory integrity organization of individuals is provided, it is possible to use their body effectively against the environment. Sensory integration therapy, which is defined as a physiologically based process by Ayres and Dunn, also provides changes in individuals' occupations.
15764455|NCT04740840|Drug|Levamlodipine|According to the inclusion criteria of the trial, those who met the diagnosis of hypertension were randomly divided into the experimental group and the control group. The experimental group was treated with 2.5mg levamlodipine to lower blood pressure. Abdominal blood was emptying before the start of the trial and at the first and third month of medication.Data on CRP, TNF-α, IL-6, Lp-PLA2 and ATP were collected.
15764456|NCT04740840|Drug|Amlodipine|According to the inclusion criteria, patients who met the diagnosis of hypertension were randomly divided into the experimental group and the control group. The experimental group was given 5mg amlodipine to lower blood pressure. Fasting blood was collected before the trial and during the first and third months of treatment. CRP, TNF-α, IL-6, Lp-PLA2 and ATP data were collected.
15764459|NCT04740814|Drug|Certolizumab pegol|"Pharmaceutical form: Solution for injection
~Route of administration: Subcutaneous Subjects will receive certolizumab pegol in a pre-specified sequence during the study."
15764460|NCT04740801|Device|Ablation procedure|Catheter ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav StablePoint ablation catheter
15764461|NCT04740788|Device|Monofocal IOL|Patients are already implanted with a monofocal lens
15764463|NCT04740762|Behavioral|Intervention group|The women in the intervention groups were administered a three-session intervention program in addition to the routine care they received.The program encompassed providing the women with an educational booklet, childbirth stories and childbirth videos that were created to reduce their fears of childbirth.The interviews were held a total of three times, in gestational weeks 28-30, 31-33 and 34-36. The duration of the intervention at each visit was 60-80 minutes. Depending on the woman's own preference, she was invited to visit the delivery room at the second or last session and meet the midwives there. The women who did not wish to go to the delivery room were alternatively provided with photographs of the delivery room so they could take a look. Again as part of the education program, the women were given the links to the selected childbirth videos and given the opportunity to watch them.
15764464|NCT04740749|Device|Compress Compliant Pre-Stress System|Treatment of malignant femor tumors with the Compress Compliant Pre-Stress System
15764466|NCT04740723|Device|iRF System Renal Denervation|The iRF System is a percutaneous, catheter-based device which uses RF energy to circumferentially denervate the sympathetic nerves surrounding the artery
15764467|NCT04740710|Behavioral|Breathing and Attention Training|A guided audio recording will instruct participants to alter their breathing and pay attention in specific ways.
15764468|NCT04740697|Other|Treatment requiring adjuvant Hormonal Therapy (HT) with tamoxifen.|"Each included patient will be referred to the health care staff for a blood sample:
~for the determination of the residual plasma concentration of tamoxifen and its active metabolites,
~for the constitution of a biobank.
~Patients will then complete a questionnaire to collect information on tamoxifen intake and adherence (via the GIRERD questionnaire), as well as possible Alternative and Complementary Therapeutics (ACT) intake (reason for use, type of ACT, ...)."
15764469|NCT04740684|Other|Standardized diet|Standardized diet is prepared in a commercial kitchen and packaged in single serve portions to provide to participants to consume for 7 days
15764470|NCT04740671|Drug|HLX04-O|Biologic recombinant anti-VEGF humanized monoclonal antibody, developed by Shanghai Henlius Biotech, Inc.
15764471|NCT04740671|Drug|ranibizumab|Biologic anti-VEGF recombinant humanized monoclonal antibody fragment
15764472|NCT04740658|Other|No intervention|There is no intervention
15764473|NCT04740645|Other|NOCDURNA Cohort|Non intervention
15764474|NCT04740645|Other|LUTS Cohort|Non intervention
15764475|NCT04740632|Behavioral|Assessment of the quality of life of mothers of children with IgE-mediated food allergy|"Questionnaire on the demographic characteristics of the mother;
~The food allergy self-efficacy scale for parents (FASE-P);
~The Food Allergy Quality of Life - Parental Burden Questionnaire (FAQL-PB);
~Food Allergy Quality of Life Questionnaire - Parent Form (children aged 0-12 years) (FAQLQ-PF)"
15764476|NCT04740619|Procedure|Natural Orifice Specimen Extraction|Natural Orifice Specimen Extraction via transanal
15764477|NCT04740606|Device|Augmented Reality Navigation System|Investigators will assess the nodules based on the CT images of subjects before procedure. And then, the appropriate intra-airway path planned by the Augmented Reality Navigation System will be selected. The bronchoscopy with intra-airway navigation under the guidance of the Augmented Reality Navigation System will be performed and the following surgical information will be record.
15764478|NCT04740593|Other|Orthoptic care with the prescription of glasses from age 12-18 months onwards|Children assigned to the intervention group (group 1) will receive orthoptic care, including exams 1-3 (depending on the refractive error) times a year, and glasses, based on accurate determinations of refractive error by retinoscopy in cycloplegia by the study orthoptists at age 12-18 months. The spectacles for the children in this study will be provided by the study via their optician without costs.
15764479|NCT04740593|Other|Orthoptic care without the prescription of glasses from age 12-18 months onwards|Children with high refractive error in the control group (group 2) will also receive orthoptic care, including exams 1-3 (depending on the refractive error) times a year, but they will not receive glasses.
15764480|NCT04740593|Other|First measurement only|Children who have no or mild refractive error (group 3), the majority of all children, will be examined by the study orthoptists only once at the age of 12-18 months, after which youth health care (YHC) physicians and nurses will continue standard vision screening at CHCs, as part of screening for general health disorders and vaccinations. Visual acuity is measured routinely at 42-48 months as part of standard vision screening.
15764484|NCT04740567|Behavioral|Cognitive Training|The cognitive training program regimen and its degree of difficulty will be tailored to the patient's current level of cognitive functioning and interests. Patients will be asked to work through progressively more challenging exercises pertaining to orientation, attention, problem-solving, and memory. These cognitive training exercises will be significantly difficult but when they can be completed easily (>85% mastery), their difficulty will be increased, and this process will be repeated as appropriate. They will also perform puzzles, games, or cognitive tasks related to their hobbies.
15764485|NCT04740567|Behavioral|Goal Management Training|"Goal management training will (1) teach patients compensatory strategies such as stop techniques [e.g., to stop and think about consequences of a decision before making it]; (2) help them to take complex tasks and divide them into manageable subtasks to increase the likelihood of completing the task; and (3) enable them to learn to regain cognitive control when their behavior becomes incompatible with their intended goals. GMT is anchored in sustained and vigilant attention theory and it enables patients to actively attend to higher order goals critical to functioning. GMT is tailored to the individual needs of the patient. During the initial session, the Cognitive Intervention Specialist will meet with the subject and their family member or caregiver to identify these functional and cognitive deficiencies."
15764486|NCT04740554|Behavioral|Duchenne Muscular Dystrophy group with Deflazacort|Subjects with duchenne muscular dystrophy undergoing drug therapy with Deflazacort
15764487|NCT04740554|Behavioral|Duchenne Muscular Dystrophy group with Prednisone/Predisolone|Subjects with duchenne muscular dystrophy undergoing drug therapy with Prednisona/Predinisolone
15764488|NCT04740554|Behavioral|Duchenne Muscular Dystrophy group without Corticosteroids therapy|Control group with duchenne muscular dystrophy without the use of corticosteroid drug therapy.
15764489|NCT04740554|Behavioral|Control Group Typically Developing|Control group with tipical development.
15764490|NCT04740541|Other|Dietary Intakes (Reference protein drinks (Scandishake, Solcarb, Beneprotein) and cookies)|Reference protein drinks (Scandishake, Solcarb, Beneprotein) and cookies to meet nutritional requirements, 5 levels of threonine intakes
15764491|NCT04740528|Diagnostic Test|fto gene testing|Blood samples were collected after a 12-h fasting by Prodia Laboratory for DNA isolation and biochemical analysis
15764492|NCT04740515|Other|pharmacists involved PPMTM|This was an open labelled randomised study. Preterm Infants With iron supplementation were recruited and arbitrarily divided into the intervention group (usual care plus PPMTM) and the non-intervention group (usual care only). Those enrolled in the research were scheduled for follow-up for eight consecutive visits. Improvements in lab results and direct costs were compared longitudinally (pre and post analysis) between the groups.
15764493|NCT04740502|Procedure|Parahtyroidectomy|Parathyroidectomy
15764494|NCT04740489|Behavioral|Phase 3 Cardiac rehabilitation|Phase 3 CR is a comprehensive outpatient programme, considered the core rehabilitation phase, in which participants receive structured exercise, health education, risk factor modification and psychological support. Upon discharge from clinically supervised phase 3 CR participants are generally signposted to long-term community-based exercise classes (phase 4). The current study will take place within a core phase 3 CR programme in the UK.
15764495|NCT04740476|Drug|STK-001|STK-001 drug product is an antisense oligonucleotide administered as an intrathecal injection.
15764496|NCT04740450|Device|Kinesio taping|skin colored Kinesio-Tex Gold tape, 50 mm _ 5 m (Kinesio Holding Corp, Albuquerque, NM) tapped in technique described by Gozluklu et al in 2020
15764497|NCT04740450|Device|Wound Tape|skin colored wound tape tapped in technique described by Gozluklu et al in 2020
15764498|NCT04740424|Drug|FS222|Dosing of participants will occur intravenously (IV), at a fixed dose in treatment cycles once every 4 weeks (Q4W) until disease progression or unacceptable toxicity.
15764499|NCT04740411|Behavioral|The Common Elements Toolbox (COMET)|COMET is an online unguided self-help intervention that lasts approximately 60-80 minutes.
15764500|NCT04740398|Drug|CBP-1008|CBP-1008 for injection；Slight yellow freeze-dried block and a small amount of powder10mg/vial;IV infusion；Infusion for 90 minutes
15764501|NCT04740385|Diagnostic Test|Lung auscultation|auscultation of air entry through chest wal
15764502|NCT04740385|Device|Fiberoptic bronchoscopy|Checking correct double lumen position through direct vision using fiberoptic bronchoscopy
15764503|NCT04740385|Device|Lung Ultrasound|real time visualization of air entry to the lungs using trans-thoracic lung ultrasound
15764504|NCT04740372|Other|No intervention. Method study. Psychometric testing|Patients will fill in the questionnaire followed by an interview (phase IIIA) or a debriefing questionnaire (Phase IIIB)
15764505|NCT04740359|Other|Functional training|The therapy program was planned for 8 weeks and the sessions were performed in 45 minutes (min) for 3 days a week. The functional reach (forward-lateral-cross), trunk rotation exercises were performed in the sitting positions.(25min) Facilitation of trunk extension and elongation in the prone position (10 min). Thoracic mobilization on exercise ball (10min).
15764506|NCT04740359|Other|Routine training|The therapy program was planned for 8 weeks and the sessions were performed in 45 minutes (min) for 3 days a week. The strengthening exercises were applied on the mat (3x10 for the first 4 weeks and 3x15 repetition for the last 4 weeks). Eyes open-closed perturbation training was performed for trunk control in sitting and standing positions (10 min.).
15764508|NCT04740333|Other|No intervention- observational study|No intervention- observational study
15764512|NCT04740294|Drug|Magnesium Sulfate|Randomized to receive either magnesium sulfate or normal saline placebo.
15764513|NCT04740281|Behavioral|Footwear|Assessment of footwear
15764514|NCT04740268|Device|Epistamp|"The patient's entire face will be treated with the Epistamp microneedling devise.
~The following settings will be used as a treatment protocol. Needle length between .02- 1.55 mm"
15764515|NCT04740255|Device|Epistamp|The patient's entire face will be treated. The following settings will be used as a treatment protocol. Needle length between .02- 1.55 mm
15764516|NCT04740229|Behavioral|Yoga|Moderate-intensity flow-based yoga movements, breathing, and relaxation for 50 minutes, 3 times per week, for 8 weeks
15764517|NCT04740216|Behavioral|exercise therapy plus jaw device|The mouth-opening rehabilitation exercise lasts for twelve weeks, five days a week, three times a day. Subjects can arrange to perform before or after meals according to personal eating time and preferences. The experimental group performs 30 minutes each time, including 20 minutes of stretching exercises. Ten-minute mouth expander assisted passive exercise.
15764518|NCT04740216|Behavioral|exercise therapy|the control group performed 20-minute stretching exercises each time.
15764519|NCT04740203|Drug|CAR-T cells targeting CD19 and CD22|Each subject receives sequential CD19 and CD22 CAR-T cells by intravenous infusion
15764520|NCT04740190|Drug|Talazoparib|low dose whole brain radiation, followed by combination talazoparib and carboplatin
15764521|NCT04740164|Procedure|Endoscopic Retrograde Cholangiopancreatography|Undergo ERCP with LMA Gastro
15764522|NCT04740164|Procedure|Endoscopic Retrograde Cholangiopancreatography|Undergo ERCP with standard nasal cannula
15764523|NCT04740151|Procedure|Best PEEP|In OLV, the investigator will perform a PEEP decremental titration trial, decreasing PEEP from 16 to 4 cmH2O (steps of 2-cmH2O, lasting 1 minute). At the end of every step driving pressure (Pplat-PEEP) will be calculated, and the PEEP corresponding to the lowest driving pressure + 2cmH2O will be set.
15764524|NCT04740151|Procedure|Standard PEEP|In OLV, a PEEP of 5 cm H2O will be set.
15764525|NCT04740138|Behavioral|Dialectical Behavioral Therapy Skills + Parent Training|"The DBT/Parent training group intervention is a novel integration of three evidence-based treatments (i.e. DBT Skills, Parent Management Training (PMT), and Emotion Coaching (EC)). The DBT Skills portion of each session follows the DBT Skills Training Manual Second Edition and DBT Skills Training Handouts and Worksheets Second Edition. DBT Skills portions cover the four modules of traditional DBT Skills: mindfulness, distress tolerance, emotion regulation and interpersonal effectiveness.
~PMT portions of the intervention cover: praise, positive interactions and parental attention, reward systems, effective commands, use of consequences, and problem solving. EC portions of the intervention cover: psychoeducation on children's emotional development, teaching children to identify and label emotions, validation of children's emotions, handling children's negative emotions, fostering children's positive emotions and parental modeling of emotion regulation and expression."
15764526|NCT04740112|Other|Foods with beta-glucan from oats and barley|Breakfast bars made with varying levels of total dietary fiber and beta-glucan, with or without claims on package image
15764527|NCT04740099|Other|SOONER Video & Kit|A brief animated video including basic instructions for opioid overdose response accompanied by a Naloxone kit with an info graphic.
15764528|NCT04740099|Other|Standard of Care|A handout including a map and list of locations offering this service.
15764529|NCT04740086|Procedure|Calcium alginate hydrogel|"The external and internal fistulous orifice and fistulous tract were explored without applying any product, including hydrogen peroxide or povidone-iodine.
~The seton was removed and FT cannulation was performed using a needle for cleaning with a gauze impregnated with saline.
~Calcium chloride was applied through the EFO until it exits through the IFO, and then the IFO was obturated.
~Alginate was applied, and the pressure at the IFO was stopped, until the alginate solution partial exits through the IFO.
~The IFO was closed with a 3/0 braided resorbable suture.
~The EFO was removed with an electric scalpel and closed with a 3/0 braided resorbable suture."
15764530|NCT04740060|Other|Augmented Feedback without Virtual Reality(VR|"For Walking Speed:One-minute fast walking with visual augmented feedback without VR interface (we ask participants to look at a screen where their walking speed and distance are tracked and increase their speed).
~For Step Length: Maximum step length with visual augmented feedback without VR interface in which we ask participants to look at a screen where their step length is displayed and attempt to increase their step length up."
15764531|NCT04740060|Other|Augmented Feedback with Non-Game based VR|"For Walking Speed:One-minute fast walking with basic VR interface (we ask participants to look at a screen where their avatar walker representative will be represented in a virtual walking environment and try to make the avatar walk faster).
~For Step Length: Maximum step length with basic VR interface in which we ask participants to look at their avatar feet in a virtual stepping environment and step with the avatar foot as far as possible."
15764532|NCT04740060|Other|Augmented Feedback with Game based VR|"For Walking Speed: One-minute fast walking with the VR Racing exergame (we ask participants to look at a screen where their avatar walker representative present in a virtual racing environment with other avatar racers and try to beat the avatar racers).
~For Step Length: Maximum step length with the VR Stepping Exergame (we ask participants to look at their avatar legs and avatar animals in a virtual stepping environment and try to step over the avatar animals without touching the animal."
15764533|NCT04740047|Diagnostic Test|Ion Endoluminal System|Robotic bronchoscopy with c-arm imaging.
15764534|NCT04740034|Drug|TNB-585|TNB-585 is a bispecific antibody targeting prostate-specific membrane antigen (PSMA) on tumor cells and CD3 on T-cells
15764535|NCT04740021|Drug|LP002|10 mg/kg administered as IV infusion on Day 1 of each 21-day cycle.
15764536|NCT04740021|Drug|Carboplatin|AUC 5 administered as IV infusion on Day 1 of each 21-day cycle.
15764537|NCT04740021|Drug|Etoposide|100 mg/m^2 administered as IV infusion on Day 1, 2 and 3 of each 21-day cycle.
15764538|NCT04740008|Drug|Low Nicotine Content Cigarettes|Low Nicotine Content Cigarettes 0.4 mg/g nicotine; 9 mg tar Other Name: Reduced Nicotine Content Cigarettes
15764539|NCT04740008|Other|Control message|Participants will read control message
15764540|NCT04740008|Other|Test message|Participants will read test message
15764541|NCT04739995|Drug|Low-dose naltrexone|4.5 mg LDN/day for 1 year
15764542|NCT04739982|Device|GuessWhat Mobile App|The GuessWhat app is a charades style game and app that engages parent and child in fluid social interaction where the parent must guess what the child is acting out based on the prompt shown on the phone screen. Participants will use their own personal phone to download the study app. Parent and child will be encouraged to play using the emojis and emotion game mode at least 3 individual game sessions per week. Parents are asked to play GuessWhat with their child 3-4 times per week for 4 weeks.
15764988|NCT04736446|Device|Face mask ventilation|Use of a face mask to deliver ventilations
15764543|NCT04739969|Device|Active TBS-DLPFC|"Participants in the active stimulation group will receive intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the Soterix Neural Navigator neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004).
~Stimulation will be delivered to the L-DLPFC using a MagPro TMS system (MagVenture, Denmark)."
15764544|NCT04739969|Device|Sham TBS-DLPFC|The parameters in the sham arm will be as above with the internal randomization of the device internally switching to sham in a blinded fashion.
15764545|NCT04739956|Other|The Hospital and Anxiety Depression Scale|Patients and partners will be asked to complete the questionnaire at three time points: 1) On classification of PUL at time zero once blood is taken, 2) at the 48-hour time point after blood is taken (if 48 hour bloods are required for the patient); and 3) after definitive diagnosis and management.
15764546|NCT04739956|Other|Point of care testing (POCT)|Patients will have 1ml sample of blood taken for POCT at two time points: 1) On classification of PUL at time zero at the same time as when routine blood samples taken; and 2) at the 48-hour time point at the same time as when routine blood samples are taken (if 48 hour bloods are required).
15764547|NCT04739943|Device|Mobile Monitoring Device|App for self monitoring device for respiratory symptoms
15764548|NCT04739930|Procedure|Autologous bone marrow aspirate will be harvested and concentrated to a bone marrow aspirate concentrate (BMAC) containing bone marrow derived mesenchymal stem cells and delivered to site of operation|Autologous bone marrow aspirate will be processed and concentrated to a bone marrow aspirate concentrate (BMAC) containing bone marrow derived mesenchymal stem cells and delivered to the site of operation in the treatment group
15764549|NCT04739930|Procedure|Control group incision|0.5cm sham incision over the iliac crest
15764550|NCT04739917|Biological|Vaccine PvCS N+C+R 150 mcg|Vaccine PvCS N+C+R 150 mcg (Montanide ISA-51), freeze dried powder.
15764551|NCT04739917|Other|Placebo SSN Montanide ISA-51 1 mL|SSN Montanide ISA-51 1 mL
15764552|NCT04739904|Other|Normoxia|48 hours experimental protocol conducted at sea level
15764553|NCT04739904|Other|Normobaric hypoxia|24 hours experimental protocol conducted in a normobaric hypoxic facility
15764554|NCT04739904|Other|Hypobaric hypoxia|72 hours experimental protocol conducted at terrestrial altitude
15764555|NCT04739878|Procedure|Airway Ultrasound|Comparison between Airway ultrasound and CT cervical
15764556|NCT04739865|Drug|Psilocybin|Open label
15764557|NCT04739852|Other|Fasting|Patients undergo a 5-10 day fasting period with a dietary energy supply 350-400kcal per day with fruit and vegetable juices or, if not feasible, an established fasting-mimicking diet of 600-800 kcal according to Longo et al.
15764558|NCT04739839|Other|survey questionnaire|Questionnaire focusing on low back pain in relation to life style, physical activity level, illness perception and quality of life.
15764559|NCT04739826|Drug|Flumatinib Mesylate|Flumatinib mesylate tablets 600mg qd
15764560|NCT04739826|Drug|Nilotinib Pill|Nilotinib Capsules 300mg bid
15764561|NCT04739813|Biological|obinutuzumab|administered intravenously, days 1 and 2, at a dose of 1000 mg; every 21 days for up to 6 cycles, or until disease progression or unacceptable toxicity
15764562|NCT04739813|Drug|prednisone|administered orally, days 1-7, at a dose of 100 mg; every 21 days for up to 6 cycles, or until disease progression or unacceptable toxicity
15764563|NCT04739813|Drug|Revlimid|administered orally, days 1 and 14, at a dose of 15 mg; every 21 days for up to 6 cycles, or until disease progression or unacceptable toxicity
15764564|NCT04739813|Biological|Polatuzumab|administered intravenously, on day 2, at varying doses of 1.4-1.8 mg/kg (based upon assigned dose level); every 21 days for up to 6 cycles, or until disease progression or unacceptable toxicity
15764565|NCT04739813|Drug|ibrutinib|administered orally, days 1-14, at a dose of 560 mg; every 21 days for up to 6 cycles, or until disease progression or unacceptable toxicity
15764566|NCT04739813|Drug|venetoclax|administered orally, days 2-14, at a dose of 600 mg; every 21 days for up to 6 cycles, or until disease progression or unacceptable toxicity
15764573|NCT04739774|Drug|CHF6001 DPI|Single dose of CHF6001
15764574|NCT04739774|Drug|Itraconazole|Repeated doses of oral Itraconazole
15764575|NCT04739761|Drug|Trastuzumab Deruxtecan|Participants will receive T-DXd administered using an IV bag containing 5% (w/v) dextrose injection infusion solution.
15764576|NCT04739748|Diagnostic Test|complete blood picture|Measure the red blood cell distribution width (RDW), the neutrophil-lymphocyte ratio (NLR).
15764577|NCT04739735|Procedure|Dental Local Anaesthesia|lower primary molar teeth indicated for extraction will be given a local anaesthetic injection according to the random allocation to one of the two arms mentioned previously
15764578|NCT04739722|Diagnostic Test|Colonosight Stool Sample Collection Kit|The ColonoSight Collection Kit provides information on how to collect a stool swab using a fecal immunochemical test (FIT) and how to collect a stool sample using the ColonoSight Collection Kit. After a stool sample is produced, patients will swab the stool sample using the FIT tube according to instructions and return the stool sample via mail courier to Geneoscopy's Laboratories. Patients will then be directed to receive a colonoscopy. If a lesion is removed during the colonoscopy, the tissue sample will be sent for histopathology review. The colonoscopy report and the histopathology report will be reported to Geneoscopy. Stool samples returned to Geneoscopy's Laboratories will be subjected to the ColonoSight test system, which includes targeted nucleic acid enrichment and biomarkers quantification via droplet digital polymerase chain reaction. The FIT returned in the ColonoSight Collection Kit will also be read by laboratory technologists at Geneoscopy.
15764609|NCT04739488|Device|Inhaler training|This training was given to both intervention groups. How the patients used their inhaler medication was evaluated. The steps to use the correct inhaler medication were taught sequentially. It was applied with the patient. At the end of the training, brochures prepared by the researchers were given to the patients.
15764581|NCT04739696|Behavioral|PEPRR|Briefly presented in the following order, sessions will include: 1) Overview and Introduction to Stress Management 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with work and caregiver stress, 5) Strategies for maintaining energy and stamina with caregiver and work demands, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs to employers and your loved ones, and 8) Getting the support they need including work accommodations and/or legal protections (e.g., Family Medical Leave Act, Americans with Disabilities Act)
15764582|NCT04739696|Behavioral|Pep-Pal|Pep-Pal program consisted of 11 sessions: 1) Introduction to stress management, 2) Stress and the mind body connection, 3) How thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty, 7) Managing changing relationships and communicating needs, 8) Getting the support they need; 9) Employment related challenges and resources for working caregivers; 10) Employment session one; 11) Employment session two
15764583|NCT04739683|Device|Foley bulb placement|A 16 F Foley catheter with a 30-mL balloon and stylet is inserted into the endocervical canal under direct visualization by sterile speculum exam or by digital palpation. The Foley catheter is advanced to or past the internal os, and the balloon is filled with 30-40 mL of sterile water. The catheter is then placed on genital traction by taping the end of the catheter to the medial portion of the thigh.
15764584|NCT04739683|Device|DILAPAN-S® placement|A bivalve speculum will be used to visualize and prepare the cervix with an antiseptic solution. The DILAPAN-S® (4 x 65 mm) will be inserted in the cervical canal until it traverses the internal os. As many dilators as needed to achieve the desired effect should be inserted. Specific number of pieces always depends on decision and clinical judgement of physician and indications. A gauze pad moistened with sterile water or saline may be inserted into the vagina to help keep the DILAPAN-S® in place, if needed
15764585|NCT04739670|Drug|Atezolizumab|Atezolizumab is a monoclonal antibody of IgG1 isotype PD-L1. It is used across a number of tumour types, both as a single-agent and in combination with other therapies such as chemotherapy.
15764586|NCT04739670|Drug|Bevacizumab|Bevacizumab is a monoclonal antibody to vascular endothelial growth factor (VEGF) which exerts its effect by inhibiting angiogenesis, a critical component of tumour growth and metastasis.
15764587|NCT04739670|Drug|Gemcitabine|Gemcitabine is a type of chemotherapy drug
15764588|NCT04739670|Drug|Carboplatin|Carboplatin is platinum based chemotherapy drug
15764589|NCT04739657|Device|InSight Lifetech IVUS System|The InSight Lifetech IVUS System is intended for examination of coronary intravascular pathology only, including TrueVisionTM intravascular ultrasound diagnostic catheter and VivoHeartTM intravascular ultrasound diagnostic device. Intravascular ultrasound imaging is used in patients who will undergo transluminal coronary intervention.
15764590|NCT04739657|Device|Boston Scientific IVUS System|The Boston Scientific IVUS System is intended for examination of coronary intravascular pathology only, including OpticrossTM coronary ultrasonic imaging catheter and iLABTM intravascular ultrasound diagnostic device. Intravascular ultrasound imaging is used in patients who will undergo transluminal coronary intervention.
15764591|NCT04739644|Device|Specific wrist rehabilitation by WRISTBOT device|The WRISTBOT is a fully backdrivable manipulandum that allows for movements along its 3 Degrees of Freedom (DoFs) in a human-like Range Of Motion (ROM) of the wrist: 62° flexion/extension (FE), -40°/+45° in ulnar/radial deviation (RUD), and 60° pronation/supination (PS). In addition, the robot permits motions along planes that involve combined multi-DoFs movements. Mechanically, the robot was developed to have low values of inertia, emulating the fluency of natural movements. Each DOF is measured by high resolution incremental encoders and actuated by one brushless motor or two in case of the RUD planes, providing both gravity compensation and continuous torque values necessary to manipulate the human wrist joints. Depending on the torques exerted, the device can be used in either active or assistive/passive modality. The system is integrated with a Virtual Reality environment (VR), useful to provide a visual feedback to the user while he/she is requested to complete the tasks.
15764592|NCT04739644|Other|Specific wrist rehabilitation performed by the physiotherapist|Passive, active and assisted mobilization
15764593|NCT04739644|Other|General rehabilitation|Exercise with elastic bands or weights, exercise of manipulation and dexterity, simulation of daily life activities supervised by the physiotherapist
15764594|NCT04739631|Other|acupuncture|use disposable sterile needles to insert to the acupuncture point
15764595|NCT04739631|Other|minimal acupuncture|The sham-controlled group will be performed with minimal acupuncture(superficial needling) at non- acupoints.
15764596|NCT04739618|Drug|Keytruda Injectable Product|PD-1 inhibitor antibody
15764597|NCT04739618|Drug|Yervoy Injectable Product|Anti-CTLA-4 antibody
15764598|NCT04739618|Drug|GM-CSF|1 mL injected into each non-ablative cryosurgical freezing zone. Daily injection administered subcutaneously. 250 mcg daily injections for a total of 25 days after each treatment.
15764599|NCT04739618|Procedure|Non-ablative Cryosurgical freezing|To induce immediate necrosis and necroptosis and a rim of injured cancer cells, thereby exposing a complete range of patient-specific tumor antigens that are specific to the treated subject.
15764600|NCT04739592|Drug|alendronate sodium vitamin D3 tablets|once per week for one year
15764601|NCT04739592|Drug|Placebo|once per week for one year
15764602|NCT04739579|Diagnostic Test|C-Reactive Protein|C-Reactive Protein trend in post-operative course
15764603|NCT04739566|Drug|Dabrafenib|Given PO twice daily
15764604|NCT04739566|Drug|Trametinib|Given PO once daily
15764605|NCT04739553|Device|His Pacing|The patients will receive a pacemaker implant with a traditional right ventricular pacing lead and an additional His pacing lead in a basal high septal position at the level of the proximal electrical conduction system (His). An atrial lead is implanted if dual chamber pacing is needed. All leads are connected to a biventricular pacemaker with the His lead in the LV port.
15764606|NCT04739527|Biological|DCP-001|allogeneic dendritic cell vaccine
15764607|NCT04739514|Other|Exercises for dysphagia rehabilitation|Diet modifications, postural exercises, compensatory exercises, swallowing exercises
15764608|NCT04739501|Procedure|TACE|Trans-arterial chemoembolization in patients with hepatocellular carcinoma
15764668|NCT04738929|Other|Extra virgin coconut oil or extra virgin olive oil|"Subjects consumed standard breakfast meals containing extra virgin coconut oil or extra virgin olive oil"
15764989|NCT04736433|Drug|ACE inhibitor|ACE inhibitor dispensing claim is used as the reference
15764610|NCT04739488|Behavioral|Breathing exercises|"This training was given only to the group that received breathing exercise and inhaler training.
~Pursed lips breathing exercises were taught to the patients. Patients were asked to continue their breathing exercise for 10 minutes before using their inhaler medication.
~Thus, it was evaluated whether breathing exercises performed before using inhaler drugs provided benefit on drug effectiveness."
15764611|NCT04739475|Procedure|Non Surgical Periodontal Therapy|"Conventional staging debridement (CSD) according to the severity of periodontal disease in 2 to 4 appointments at day 0, 7, 14 and 21.
~Supra and subgingival scaling and polishing will be performed by the use of manual and ultrasonic instruments and oral hygiene instructions will be given. Patients will be instructed to use interdental brushes with appropriate size interdental brushes or dental floss when interdental embrasures will not allow for interdental brushing."
15764612|NCT04739462|Behavioral|mHealth Platform|All participants randomized to the intervention group will receive 2-4 informational texts each week and will also receive interactive health screening questions throughout enrollment. A participant will also receive appointment reminder texts. All SMS text messages will be transmitted through a local organization known as The Medical Concierge Group (TMCG) via an electronic system that allows for bulk messaging. TMCG also staffs a 24-hour call line for those using TMCG services to call in for medical related questions. This call line is staffed by doctors and nurses; SMS Maama participants randomized to the interventional group will be able to access this call line free of charge as part of their enrollment in SMS Maama.
15764613|NCT04739449|Behavioral|Coaching, Cleaning, Communication, Collaboration|"Coaching staff
~Cleaning protocols, standardized
~Communication with staff and leadership
~Collaboration with local expertise"
15764614|NCT04739436|Device|Hearing amplification|Bilateral vs. unilateral hearing aids for hearing loss
15764616|NCT04739410|Drug|Ivermectin|Ivermectin Prescribing protocol: Participants were prescribed Ivermectin 12 mg per oral stat and then 12 mg per oral after 12 hours and 12 mg per oral after 24 hours and we looked at the response at day 7 on follow up in terms of improvement of symptoms like (Fever, Cough, sore throat, Headache, Shortness of breath, lethargy, and fatigue.Any side effects of the drugs were noted as well
15764617|NCT04739397|Device|Glare Testing|Vision in Cataract patients were tested with and without the EpiGlare Tester
15764618|NCT04739384|Drug|Ticagrelor 90mg|Ticagrelor 90 mg followed by Ticagrelor 60 mg
15764619|NCT04739384|Drug|Ticagrelor 60 mg|Ticagrelor 60 mg followed by Ticagrelor 90 mg
15764620|NCT04739371|Drug|Insulin, Regular, Human|The spray will last a few seconds and then the participant will be asked to sniff to aid the drug into the nose. The device (i.e. ViaNase) is an atomizer that uses its patented technology that turns the liquid into a fine mist of droplets to facilitate the drug along the nose to brain pathway. Each nostril will receive this administration 2 times for a total of 40 IUs or 0.4 mL of liquid.
15764621|NCT04739371|Drug|Placebo|The spray will last a few seconds and then the participant will be asked to sniff to aid the saline into the nose. The device (i.e. ViaNase) is an atomizer that uses its patented technology that turns the liquid into a fine mist of droplets to facilitate the drug along the nose to brain pathway. Each nostril will receive this administration 2 times for a total of 40 IUs or 0.4 mL of liquid.
15764622|NCT04739358|Drug|Tepotinib|Subjects will receive tepotinib daily in cycles of 21-day duration. Subjects in the Combination Therapy arm will continue to receive their last tolerable dose of tyrosine kinase inhibitor (TKI) together with tepotinib.
15764623|NCT04739332|Behavioral|The Newborn behavioral observations system|The NBO system is a relationship building tool to enhance parental sensitivity in the newborn period. Mothers at risk for post-partum depression are supported by a clinician to respond with confidence to their newborn's individual needs.
15764624|NCT04739319|Other|N/A Observational study|N/A Observational study
15764625|NCT04739306|Biological|CT-P42|2mg/0.05 mL by Intravitreal injection
15764626|NCT04739306|Biological|Eylea|2mg/0.05 mL by Intravitreal injection
15764627|NCT04739293|Drug|ON123300|ON 123300 hard gelatin capsules
15764628|NCT04739280|Other|Not an intervention|Not an intervention
15764629|NCT04739267|Device|CardioFlux|Not an intervention
15764630|NCT04739254|Other|Not an intervention|Not an intervention
15764631|NCT04739241|Drug|premixed insulin therapy|Premixed insulin treatment: 30% of the calculated dose was administered before breakfast and before lunch (biphasic insulin lispro 50% or biphasic insulin aspart 50%) and the remaining 40% of the dose before dinner (biphasic insulin lispro 25% or biphasic insulin aspart insulin 30%).
15764632|NCT04739241|Drug|basal bolus insulin therapy|Basal-bolus insulin treatment: 50% dose in insulin glargine and 50% dose in insulin lispro or aspartic, distributed in equal parts in the 3 main meals
15764633|NCT04739228|Behavioral|Guided Written Disclosure Protocol Group|The writing task consists of three sessions of 20 minutes each, with an interval of one week between each other. In the first session, patients were asked to describe the onset of illness, describing chronologically and detailed places, images, sounds and actions, as they are followed and detached from the emotions. In the second session, the patients were asked to write about thoughts and emotions felt during the illness experience, talking about the impact that illness had on their daily lives and how it had changed their personal attitude to life itself. In the third and final session, the patients were asked to analyze subjective new skills acquired.
15764634|NCT04739228|Behavioral|Active Control Group|The writing task also consists of three sessions of 20 minutes each, with an interval of one week between each other. In all three writing sessions, patients were asked to report the daily activities during the last week, without focusing on the emotional aspects.
15764635|NCT04739215|Drug|Dapagliflozin 10 MG [Farxiga]|Dapagliflozin 10 mg / day oral
15764636|NCT04739215|Drug|Placebo|One Placebo capsule daily oral
15764637|NCT04739202|Drug|Atezolizumab + Ipatasertib|Atezolizumab IV (1200 mg on day 1 of each 21-day cycle) and Ipatasertib PO (400 mg per day continuously, starting on cycle 1 day 1). Treatment given until disease progression or unacceptable toxicity.
15764638|NCT04739202|Drug|Atezolizumab + Bevacizumab|Atezolizumab IV (1200 mg on day 1 of each 21-day cycle) and Bevacizumab IV (15 mg/kg on day 1 of each 21-day cycle). Treatment given until disease progression or unacceptable toxicity.
15764701|NCT04738656|Dietary Supplement|Diet plan|Mediterranean style is a non-restricted diet plan compared with the open protein diet plan
15764639|NCT04739189|Behavioral|Con : control condition without exercise / rest condition|Control condition without exercise / rest condition. The adolescents will be asked to remain quiet and at rest during the morning and will receive an ad libitum meal at dinner time. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals.
15764640|NCT04739189|Behavioral|Def-EX : Condition with an exercise-induced energy deficit|Condition with an exercise-induced energy deficit The adolescents will be asked to complete an acute exercise set at 65% of their capacities (cycling) during the afternoon, inducing an energy expenditure of 400 kcal. Dinner will be served ad libitum. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals.
15764641|NCT04739189|Behavioral|Def-EI : Condition with an energy-restriction energy deficit|Condition with an energy-restriction energy deficit The adolescents will be asked to remain quiet during the whole day (no physical activity). They will receive a calibrated breakfast reduced from 400 kcal compare to their CON and Def-EX conditions. Dinner will be served ad libitum. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals.
15764642|NCT04739176|Other|One-on-one rehabilitation program including computerized mirror therapy in addition to standard rehabilitation.|atients will be admitted to the day hospital 2 days a week for 9 weeks. They will participate in a one-on-one rehabilitation program conducted by a multidisciplinary team including a physiotherapist, psychomotor therapist, occupational therapist and a physical activity monitor. Patients will also participate in 12 computerized mirror therapy sessions (twice a day, 2 days a week, from week 4 to 6 of the program).
15764644|NCT04739137|Diagnostic Test|DDiVAT Testing|Participants will self examine his/her distance visual acuity via application in a simulation room of our department with certain predetermined environmental lighting conditions using the same smart devices.
15764645|NCT04739137|Diagnostic Test|Distance visual acuity assessment via ETDRS chart|The distance visual acuity of each participant will be measured with the conventional method via ETDRS chart
15764646|NCT04739124|Other|Follow-up questionnaires|"The patient normally follows the education program as usual but research specific data is collected:
~Biological sampling at the start and end of the education program (glycated hemoglobin).
~Retrieval of usage and glycemic balance data from the Libreview online platform (at one week, one month and three months of use)
~Iterative questionnaires allowing the study of factors of acceptance, appropriation and use (at the start of the study, at 4 weeks, at 12 weeks)"
15764647|NCT04739124|Other|Interviews|Semi-structured interviews will be carried out during the visits, either face-to-face or remotely.
15764648|NCT04739111|Drug|Human Anti-PD-L1 Monoclonal Antibody Injection (LDP) Combined with Recombinant Anti-EGFR Human Mouse Chimeric Monoclonal Antibody Injection (CDP1)|In the dose-escalation phase, CDP1 400 mg/ m2 will be given in the first week, then 250 mg/m2 will be given evert week. LDP will be given every two weeks with dose climbing of 5 mg/kg, 10 mg/kg, 20 mg/kg. Dose in the dose-expansion phase according to the assesment in the dose-escalation phase.
15764649|NCT04739085|Diagnostic Test|Defocus curves - Monocular distance visual acuity with trial lenses added to the best correction for distance|The monocular distance visual acuity of each participant' eye is evaluated using trial lenses of -3.00 sph, -2.50 sph, -1.75 sph, and -1.25 sph (added to the best correction for distance), which correspond to distances 30 cm, 40 cm, 60 cm and 80 cm, respectively.
15764650|NCT04739085|Diagnostic Test|wDDART - Monocular near visual acuity using the best correction for distance|The same participants undergo visual acuity test via the web-based digital near vision reading test wDDART at 30 cm, 40 cm, 60 cm and 80 cm, having their best correction for distance.
15764651|NCT04739072|Procedure|Biospecimen Collection|Undergo collection of blood and tissue samples
15764652|NCT04739072|Other|Electronic Health Record Review|Review of medical records
15764654|NCT04739046|Drug|Theragene arm|Theragene®,Ad5-yCD/ mutTKSR39rep-ADP with radiation therapy
15764655|NCT04739033|Behavioral|VIVIR MEJOR EXPERIMENTAL|"This group will receive access to the web-based lifestyle intervention (exercise and nutritional education), supported by audiovisual instructions given by their hypertension specialist doctor.
~The self-applied online program will comprise a three months behavioural intervention composed by 9 modules seeking to develop gradually achieving the goals of changing eating and physical activity habits, supported by audiovisual instructions. This group will receive access to the web-based lifestyle intervention (exercise and nutritional education), supported by audiovisual instructions given by their hypertension specialist doctor."
15764656|NCT04739020|Diagnostic Test|Resp-Aer-Meter|Measurement of respiratory aerosols (particle size and concentration) through breathing into the Resp-Aer-Meter for 3-6 Minutes and comparison between groups.
15764657|NCT04739020|Diagnostic Test|Spirometry|Comparison of peak expiratory flow (PEF) and forced expiratory volume in one second (FEV1) between groups.
15764658|NCT04739020|Diagnostic Test|Qualitative and quantitative virus PCR of respiratory secretions in patients with high aerosol concentrations|Comparison between result of aerosol measurement and quantitative and qualitative virus PCR of respiratory secretions that are caught in a filter in which the patient breathes for 10 minutes. Test will be conducted on patients with high aerosol concentrations (>5000/L).
15764659|NCT04739007|Procedure|Veno-arterial extracorporeal membrane oxygenation (VA-ECMO)|VA-ECMO used for resuscitation after cardiac arrest
15764660|NCT04739007|Device|Electrical Impedance Tomography (EIT)|EIT used to demonstrate ventilation and perfusion distribution in intubated patients on VA-ECMO
15764661|NCT04738994|Dietary Supplement|whey protein-enriched nutritional supplement|Standard hospital diet + 80 g/die (two servings) of whey protein-enriched nutritional supplement dissolved in 125 ml of water
15764662|NCT04738994|Other|Control group|Standard hospital diet
15764663|NCT04738981|Drug|UC-MSC|UC-MSC, iv, 1×10^6 cells/kg, once a week, for 4 weeks.
15764664|NCT04738981|Drug|Anti-CD25 mAb|Anti-CD25 mAb, iv, 20mg，twice in first week and once a week thereafter, for 4 weeks.
15764665|NCT04738968|Device|Cochlear implant|A cochlear implant is standard care for profoundly deaf persons. It enables hearing through electrical stimulation of the auditory nerve.
15764666|NCT04738955|Drug|Micafungin Sodium|micafungin sodium ≥ 100, <200mg/time, once a day, intravenous drip. Low dose group
15764667|NCT04738942|Drug|Vedolizumab|Vedolizumab 300 mg, IV infusion
15764669|NCT04738916|Device|Whole-body vibration training|Whole body vibration (WBV) is a form of treatment that has been shown to have an important role in increasing neuromuscular performance, improving muscular strength, balance. The technique involves standing and holding positions, or performing prescribed exercises, on a platform that is vibrating at a programmed frequency, amplitude, and magnitude of oscillationWhole-body vibration (WBV) is a therapeutic method that exposes the entire body to mechanical oscillations while the patient stands or sits on a vibrating platform.
15764670|NCT04738903|Procedure|Femtosecond laser assisted LASIK eye surgery|FS-LASIK eye surgery includes corneal flap creation with femtosecond laser using the Femtosecond laser WaveLight FS200 followed by excimer laser vision correction of the patient's refractive error using excimer laser WaveLight EX500.
15764671|NCT04738890|Behavioral|Mindfulness-based cognitive therapy|Mindfulness-based cognitive therapy adapted for parents and carers of children with food allergy (MBCT-PCCFA) offered live online by video-conferencing
15764672|NCT04738890|Other|Treatment as usual|Continuance as planned of whatever other treatments or interventions the participants were receiving at the time of recruitment.
15764673|NCT04738877|Diagnostic Test|Body fat measurement|Body fat measurement using skinfolds
15764674|NCT04738877|Diagnostic Test|Cardiopulmonary exercise testing|Electrocardiographic exercise testing with ergospirometer on a treadmill
15764675|NCT04738877|Diagnostic Test|Echocardiography|Transthoracic echocardiography
15764676|NCT04738877|Diagnostic Test|Blood test|Blood test for measurement of haemoglobin, serum electrolytes, iron, ferritin and vitamins
15764677|NCT04738864|Diagnostic Test|ultrasound|extracranial and intracranial ultrasound assessment
15764678|NCT04738851|Other|Therapy Mirror task|"The protocol has 3 conditions:
~A virtual TM task (TMV
~A classic TM task (TMC)
~A control task (TC)
~The order of the 3 conditions will then be randomized to avoid potential biases linked to the sequence of conditions."
15764679|NCT04738838|Drug|Oxytocin nasal spray|Intranasal treatment with oxytocin via nasal spray (48 IU per dose)
15764680|NCT04738838|Drug|Placebo nasal spray|Intranasal treatment with placebo via nasal spray
15764682|NCT04738812|Drug|Intensified TB treatment (initial phase)|"8 weeks of RHEZ with high dose of rifampicin (R) and isoniazid (H). Fixed dose combination (FDC) of RHZE with the addition of FDC of RH and single caps of R.
~6 weeks of prednisone with tapering doses. 3 days of albendazole 400 mg."
15764683|NCT04738812|Drug|WHO standard TB treatment (initial phase)|8 weeks of RHEZ with FDC.
15764684|NCT04738799|Behavioral|Carbohydrate-Last Meal Sequence|Carbohydrates consumed last during mealtimes for 6 days
15764685|NCT04738799|Behavioral|Carbohydrate-First Meal Sequence|Carbohydrates consumed first during mealtimes for 6 days
15764686|NCT04738786|Procedure|1.5 cm surgical safety margin for cT1-2N0 oral tongue cancers|"Surgical resection including 1.5 cm normal tissue around the gross tumors
~Definition of safety margin: A surgical safety margin is defined as the margin of apparently non-tumorous tissue around a tumor that has been surgically removed (Resected normal-looking tissues from the gross tumor border). The surgical safety margin is applied to all directions of 3-dimensional tumors (mucosal and deep side)."
15764687|NCT04738786|Procedure|1.0 cm surgical safety margin for cT1-2N0 oral tongue cancers|Surgical resection including 1.0 cm normal tissue around the gross tumors
15764688|NCT04738773|Drug|Naltrexone|On the active drug group, naltrexone will be prescribed on flexible dose mode, receiving 50mg per day on the first week, with an increase of 25mg each week until a maximum of 200 mg per day or as much as tolerated by the patient.
15764689|NCT04738773|Drug|Placebo|Placebo
15764690|NCT04738747|Behavioral|WHOOP fitness tracker|WHOOP is a device that uses a wristband or arm band to track heart rate, heart rate variability (HRV), and sleep to calculate proprietary strain and recovery scores for its users. Heart rate variability is an important metric for correlation with acute stress
15764691|NCT04738734|Device|CellFX System Device|The CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death.
15764692|NCT04738734|Device|Cryosurgery Liquid Nitrogen Sprayer|Cryosurgery will be standardized across all investigational sites using the Brymill Cry-Ac spray canister with standard cryoprobe.
15764693|NCT04738721|Behavioral|Evaluation|"Within the scope of the course, the demographic information of the students (such as height, weight, body mass index) is recorded and the physical activity status is recorded with International Physical Activity Questionnaire Short Form (UFAA). Cardiovascular endurance with 6-Minute Walking Test, flexibility and circumference of waist, hip and neck with the Sit and Lie Test and body composition and Body Fat Ratio will be evaluated. After a full year of quarantine, the same students who were previously evaluated and accepted to participate in the current study will be evaluated with online remote video viewing methods (Teams, Zoom, etc.) and, with the same tests and measurements under supervision by the researchers."
15764694|NCT04738708|Other|Telemedicine|Referring to the interactions between remote healthcare professionals and patient/ caregivers for the purposes of direct clinical care.
15764695|NCT04738708|Other|Routine in-person counselling|Face-to-face genetic counselling.
15764696|NCT04738695|Diagnostic Test|Point-of-care rapid anti-SARS-CoV-2 antibody test (Orient Gene Biotech) and Dry Blood Spot collection (Euroimmun)|Bimonthly finger pricks with collection of 1-10 drops of capillary blood for detection of anti-SARS-CoV-2 immune markers
15764697|NCT04738682|Other|Digital dietary registration|"The purpose of the intervention is to test whether digital dietary registration can yield more precise and consistent data, than conventional pen and paper based registration.
~Furthermore a subjective evaluation of the use of digital registration will be conducted by the staff upon completion of the intervention. The format will be individual interviews held by the investigators."
15764698|NCT04738682|Other|Conventional dietary registration|The conventional way of doing dietary registration. This is done by a paper form, with the dietary options listed. The form is then filled in and logged by staff working in the afternoon.
15764699|NCT04738669|Other|mHealth|The mHealth intervention includes telephonic call and SMS.
15764700|NCT04738669|Behavioral|Teach-back|While the teach-back includes counselling session related to discharge instruction including medication adherence.
15764702|NCT04738643|Other|Tobacco Use Treatment Service and Varenicline Management|The VM intervention builds upon the established TUT Service process. In addition to connecting the patient to TUT Service via electronic referral, it activates a medication management protocol that: 1) actively confirms no evidence of renal failure or pregnancy with oncology provider, 2) automates a referral to prescribing providers within the TUT Service team, prompting a call-back to patient within 24 hours, 3) provides written AVS instructions to contact TUT Service for initiation instructions and clinic appointment, and 4) pends a varenicline prescription to the medication list, ready for reconciliation by TUT Service prescribing clinicians. The protocol formalizes standard management principles for varenicline, including follow-up evaluation, pre-quit period duration, and side effect amelioration.
15764703|NCT04738630|Drug|HX008|200 mg administered as IV infusion on Day 1 of each 21-day cycle.
15764704|NCT04738617|Behavioral|Inter and intra-individual variation in acute responses to two different warm-up types|Comparison of the acute effects of two different warm-up protocols on subsequent performance.
15764705|NCT04738604|Other|Ceram•X (Dentsply De Trey GmbH, Konstanz, Germany|The prepared cavities will be restored with Ceram•X (Dentsply De Trey GmbH, Konstanz, Germany) with incremental placement technique (maximum: 2-mm layer). Increments will be light curing for 20 seconds according to manufacturer's instructions.
15764706|NCT04738604|Other|Zenit Nano Ceramic Composite (PRESIDENT DENTAL, GmbH, Munich, Germany)|The prepared cavities will be restored with Zenit Nano Ceramic Composite (PRESIDENT DENTAL, GmbH, Munich, Germany) with incremental placement technique (maximum: 2-mm layer). Increments will be light curing for 40 seconds according to manufacturer's instructions.
15764707|NCT04738591|Device|DIABE-TEXT|Participants will receive daily (from monday to friday) text messages in their mobile phones during three months.
15764708|NCT04738565|Dietary Supplement|Probiotic preparation|The mixture of Lactobacillus rhamnosus ŁOCK 0900, Lactobacillus rhamnosus ŁOCK 0908 and Lactobacillus casei ŁOCK 0919 administered once a day at a dose of one billion for 3 months.
15764709|NCT04738565|Dietary Supplement|Maltodextrin|Maltodextrin comparable in color, texture and taste to the probiotic mixture administered once a day for 3 months.
15764710|NCT04738552|Device|Nelli|Nelli detects and registers activity that is indicative of seizure events. Nelli captures, stores, and processes video and audio recordings from each patient. Biomarker data is collected during periods of rest for the length of an examination period, which may span several days or months (when used inside and outside of a hospital setting, respectively), as prescribed by a treating physician.
15764711|NCT04738539|Drug|Contrast Enhanced Voiding Urosonography with Urodynamic Testing|We will be using contrast enhanced voiding urosonography to image urodynamic testing on patients with neurogenic bladder.
15764712|NCT04738539|Diagnostic Test|Urodynamic Testing|We will be using contrast enhanced voiding urosonography to image urodynamic testing on patients with neurogenic bladder.
15764713|NCT04738526|Other|lithium disilicate (IPS e-max) ceramic crown|monolithic lithium disilicate ceramic crown
15764714|NCT04738526|Other|New gradient technology zirconia (5Y-TZP\ 3Y-TZP) IPS e.max ZirCad Prime ceramic crown|conjunction with the two zirconium oxide raw materials 3Y-TZP and 5Y-TZP is responsible for producing a continuous, seamless progression of the shade and translucency within the material
15764715|NCT04738526|Other|natural tooth|natural tooth is composed of enamel. Enamel is on the surface of every tooth and it has a natural hue of white. However, the underlying dentin layer has a slightly yellowish color. This yellowish hue shows through the enamel in almost everyone
15764716|NCT04738513|Procedure|Vertical preparation technique|Teeth in dental esthetic zone will receive Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns using vertical preparation technique.
15764717|NCT04738513|Procedure|Conventional Preparation technique|Teeth in dental esthetic zone will receive Monolithic Zirconia (5Y-TZP/3Y-TZP) Crowns using conventional preparation technique.
15764718|NCT04738500|Procedure|PENG Block combinated with PCA|After spinal anesthesia PENG block will be performed
15764719|NCT04738500|Procedure|PCA|PCA will be applied after surgery
15764722|NCT04738474|Behavioral|Promoting Resilience in Stress Management (PRISM)|"Develops personal resilience resources through 1:1 sessions with a PRISM coach."
15764723|NCT04738474|Other|Usual Care|No additional study-specific interaction with subjects. Subjects continue to receive usual medical care.
15764724|NCT04738461|Other|Telerehabilitation|The Posterior Glenohumeral Capsule Stretching Exercise, Pectoral Stretching Exercise, Push-up Against Wall Exercise, Scapular Plan Exercise, 90 Degree Shoulder Flexion Exercise, Isometric External Rotation Exercise and Isometric Internal Rotation Exercise will be applied according to the severity of the disease and the size of the disability.
15764725|NCT04738461|Other|Standard Physiotherapy|Active-passive exercises accompanied by a physiotherapist and physical therapy methods (electrotherapy and thermotherapy) will be applied in accordance with the standard procedure according to the patient's needs.
15764726|NCT04738461|Other|Home Exercise Group|The same exercise program applied to telerehabilitation group.
15764727|NCT04738448|Behavioral|Art Therapy Group|The art therapy intervention will be executed by the same Medical University of South Carolina (MUSC) board-certified art therapist for each group. The art therapist is a masters-level, licensed practitioner who has experience working in the healthcare system and treating providers. The same art therapy practices that are utilized in daily practice at MUSC will be employed in this study, with a focus on reducing burnout symptoms. Pilot testing of the intervention has been performed informally at MUSC with positive feedback reported by healthcare providers.
15764728|NCT04738422|Drug|Alkaline glycine|Subjects will inhale alkaline glycine via nebulizer. Alkaline glycine is an alkaline medication designed for medication.
15764729|NCT04738383|Procedure|Version 1: Paramedic|Instead of a physician, who is constantly present, a paramedic is present next to the instructor during the sessions, who can give first aid in case of an emergency and bridge the time until the ambulance arrives on site. The physician still acts as a supervisor visiting the group roughly every six weeks.
15764990|NCT04736433|Drug|Sacubitril/Valsartan|Sacubitril/Valsartan dispensing claim is used as the reference
15764730|NCT04738383|Procedure|Version 2: Physician-on-call|This version implicates that a physician is not physically present but is on call during the sessions and must be constantly accessible by phone and able to arrive within three minutes in case of an emergency. To ensure this, version two should be implemented in facilities, which are linked to cardiac or rehabilitation center.
15764731|NCT04738383|Procedure|Version 3: Trained instructor|The sessions take place with the instructor only, who receives a comprehensive emergency training before and during the model phase and replaces the constantly present physician. Just like in the previous versions the physician still acts as a supervisor visiting the group roughly every six weeks.
15764732|NCT04738370|Other|Sample collection|Bloods +/- urine +/- vaginal swabs taken
15764733|NCT04738357|Drug|HSK21542|HSK21542：1 µg/kg
15764734|NCT04738357|Drug|Placebo|Placebo
15764735|NCT04738344|Device|Percutaneous Coronary Intervention and Stent Implantation|Percutaneous Coronary Intervention and Stent Implantation will be implanted as recommended by guidelines and according to the standard techniques.
15764736|NCT04738318|Drug|Glucocorticoids|Patients will receive a single intraoperative dose of 10mg of intravenous dexamethasone intraoperatively. Following surgery, the participant will be provided with a six-day oral methylprednisolone taper course.
15764737|NCT04738318|Drug|Saline|Patients will receive a single intraoperative dose of 10 mg of saline. Following surgery, the participant will be provided with a six-day placebo course.
15764738|NCT04738305|Other|Dignity Therapy|"The Italian version Dignity Therapy intervention (Chochinov HM 2015) has been delivered. Intervention questions were not previously delivered to patients.
~DT interview was provided to patients by Specifically trained Nurses. Interviews were audio-recorded and transcribed then revised by the patients to develop the final Generativity Document. Generativity Document was delivered to patients that could share it with their loved ones."
15764741|NCT04738279|Device|Non-Invasive Continuous Remote Patient Monitoring|Continuous remote patient monitoring will consist of continuous collection of physiological data and patient status through a non-invasive wearable solution, connected to a structured cascading escalation management pathway
15764742|NCT04738279|Other|Affective Analysis of Participant Response to Continuous Remote Patient Monitoring|Survey and qualitative interviewing of participants
15764743|NCT04738266|Diagnostic Test|Amyloid Cardiomyopathy|Echocardiographic red flags of Amyloid Cardiomyopathy to guide the suspicion of disease and to proceed with second level diagnostic work up including cardiac scintigraphy with bone tracers and search of monoclonal component in serum and urine
15764744|NCT04738253|Diagnostic Test|Ultrasonography|The ultrasound measurement s of the axillary recess capsule thickness.
15764745|NCT04738240|Diagnostic Test|Intra-operative endoscopy|Intra-operative endoscopy to assess rectal anastomosis
15764746|NCT04738227|Radiation|Low-Level Laser Therapy|Low level laser will be applied and post laser results will be seen to assess any improvements.
15764747|NCT04738214|Other|Neoadjuvant CCRT+operation +/- adjuvant treatment|Patients receive neoadjuvant CCRT and operation. Adjuvant treatment after operation is performed depending on pathologic response. The patients showing pathologic complete response after neoadjuvant CCRT are not treated with any adjuvant treatment.
15764748|NCT04738201|Other|Proprioceptive thumb exercises.|Exercises for recognition of thumb position and thumb force sense.
15764749|NCT04738188|Procedure|DEB-TACE|Drug-eluting beads transcatheter arterial chemoembolization
15764750|NCT04738188|Procedure|cTACE|Transcatheter arterial chemoembolization
15764751|NCT04738188|Device|Drug-eluting Beads|Drug-eluting beads
15764752|NCT04738188|Drug|Epirubicin|Chemotherapy drug for intra-arterial infusion
15764753|NCT04738175|Biological|COVI-AMG|COVI-AMG is a fully human SARS-CoV-2 neutralizing monoclonal antibody (mAb)
15764754|NCT04738175|Drug|Placebo|Diluent solution
15764755|NCT04738162|Drug|5-Aminolevulinic Acid Hydrochloride, Oral|Application of 5-ALA oral solution (20mg/kg bw) 4 hours (range 3.5-4.5 hours) prior to anesthesia followed by fluorescence-guided tumor resection Tumor resection is performed conventionally using a surgical microscope. A change from white light to blue light is possible at anytime to make the fluorescence visible
15764759|NCT04738136|Drug|S-1226|S-1226 has two components delivered by inhalation. It is a mixture of perfluorooctylbromide (PFOB) delivered in vapour form within a medical gas mixture containing CO2. The PFOB component remains the same but the medical gas component contains 4%, 8%, or 12% CO2
15764760|NCT04738123|Drug|Xanomeline and Trospium Chloride Capsules|Oral xanomeline 50 mg/trospium 20 mg BID on days 1-2 followed by xanomeline 100 mg/trospium 20 mg BID on days 3-7. The dose is increased to xanomeline 125 mg/trospium 30 mg BID on days 8-35 unless the subject is experiencing adverse events from the xanomeline 100 mg/ trospium 20 mg dose. Subjects who were increased to xanomeline 125 mg/trospium 30 mg will have the option to return to xanomeline 100 mg/ trospium 20 mg depending on clinical response and tolerability.
15764761|NCT04738123|Drug|Placebo|Placebo Capsules
15764762|NCT04738110|Other|MRI|Structural MR (T2, FLAIR, T1 and T1+C), DCE, DSC
15764763|NCT04738097|Drug|Ticagrelor 90mg|ASA 325 mg stat and ticagrelor 180 mg stat, then ASA 80 mg daily and ticagrelor 90 mg BID for 21 days.Treatment will be continue with ASA 80 until 3 months.
15764764|NCT04738097|Drug|Clopidogrel 75 mg|ASA 325 mg stat and clopidogrel 300 mg stat, then ASA 80 mg and clopidogrel 75 mg daily for 21 days.Treatment will be continue with ASA 80 until 3 months.
15764765|NCT04738084|Behavioral|Meru Health Program|Each week of the 12 week program follows a different theme. Patients and therapists interact asynchronously after their initial Zoom-based intake call. Psychiatrists and medical doctors are available for consults if needed.
15764766|NCT04738071|Device|PFO closure|PFO closure after stroke or transient ischemic attack
15764767|NCT04738058|Drug|Bovine Lactoferrin Supplement|Bovine lactoferrin or placebo will be given to both arms with each feed for 30 days or till discharge from NICU the Lactoferrin dose 100mg/day Then determin is effect by serum zonulin level
15764768|NCT04738058|Drug|placebo|placebo
15764769|NCT04738045|Drug|Remdesivir|Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily.
15764770|NCT04738045|Drug|Lopinavir/ Ritonavir and Remdesivir combination|Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily and Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days
15764771|NCT04738032|Other|Digital Storytelling Intervention|12-minute digital storytelling intervention in Spanish, with four individuals explaining their personal Type 2 Diabetes stories.
15764772|NCT04738019|Diagnostic Test|Medical examination or treatment.|Medical examination or treatment when delayed on-set nodule or other side effects occur due to Y-Solution filler injection.
15764773|NCT04737993|Drug|licocain|pulsed radiofrequency stimulation
15764774|NCT04737993|Other|pulsed radiofrequency stimulation|pulsed radiofrequency stimulation of joint capsel
15764775|NCT04737980|Drug|Liposomal bupivacaine|Injection of 10 ml of liposomal bupivacaine 1.3% (133 mg) for ultrasound guided interscalene block
15764776|NCT04737980|Drug|Bupivacaine Hcl 0.5% Inj|Injection of 10 ml of 0.5% bupivacaine hydrochloride as admixture for ultrasound guided interscalene block
15764777|NCT04737980|Drug|Ropivacaine 0.5% Injectable Solution|Injection of 30 ml of ropivacaine 0.5% injectable solution for ultrasound guided interscalene block
15764778|NCT04737980|Drug|Dexamethasone|Injection of 8mg (2ml) dexamethasone injectable as admixture
15764779|NCT04737967|Drug|Venlafaxine|Patients will receive will receive Venlafaxine extended release (37.5 mg) tablets once daily(Zimmerman et al., 2016)
15764780|NCT04737967|Drug|Memantine|Patients will receive memantine (10 mg) once daily (Morel et al., 2016)
15764781|NCT04737954|Diagnostic Test|Venepuncture|Venous blood draw
15764782|NCT04737954|Diagnostic Test|Fingerstick|Capillary blood draw
15764783|NCT04737941|Procedure|Endothermal Ablation|Endothermal ablation is performed to suitable insufficient truncal veins (Great-, Anterior Accessory- and/or Small Saphenous Vein)
15764784|NCT04737941|Procedure|Foam Sclerotherapy|Foam sclerotherapy is performed to insufficient veins distal to the truncal superficial veins.
15764785|NCT04737928|Drug|Latanoprost|latanoprost 0.05%(one drop, once daily)
15764786|NCT04737928|Drug|tafluprost|tafluprost 0.015% (one drop, once daily)
15764787|NCT04737915|Behavioral|Exposure Therapy (In Vivo)|Participant completes a single session of exposure therapy for fear of heights by looking over railings into an atrium at various floor levels in a virtual environment.
15764788|NCT04737915|Behavioral|Exposure Therapy (Virtual Reality)|Participant completes a single session of exposure therapy for fear of heights by looking over railings into an atrium at various floor levels in a real environment.
15764789|NCT04737902|Procedure|Erector spinae plane block|Unilateral ESP block was performed between T3 and T7 levels depending on the thoracic surgical incision. The patient is placed in lateral decubitus position, under sterile conditions, a high frequency (6-15 MHz) linear-array transducer (Sonosite® Edge II, Bothell, USA) was placed in a longitudinal parasagittal orientation 2 cm from the posterior midline to visualise the tips of the transverse processes deep to the erector spinae muscle (ESM). A 21 G, 50 mm or 100 mm needle (Pajunk UniPlex NanoLine; Germany) was advanced in-plane with the ultrasound beam. The needle tip was directed to the plane between the transverse process and the posterior fascia of the ESM. Correct needle tip location was confirmed by ultrasound visualisation of linear fluid spread in the fascial plane. The injection of 0.5 to 1 ml of bupivacaine was 0.5% with epinephrine 5 µg/ml; then, a total of 20-30 ml of the same local anaesthetic was administered.
15764790|NCT04737889|Drug|Rituximab|Induction Chemotherapy: 375mg/m2, Intravenous administration on day 0 of each 3-week cycle until disease progression/stable disease or unacceptable toxicity develops, up to 6 cycles.
15764791|NCT04737889|Drug|Lenalidomide|"Induction Chemotherapy: 25mg, oral administration on day 1 to 10 of each 3-week cycle until disease progression/stable disease or unacceptable toxicity develops, up to 6 cycles.
~Maintenance Treatment: 10mg oral administration on day 1 to 21 repeated every 4 weeks until disease progression or unacceptable toxicity develops, up to 12 cycles."
15764792|NCT04737889|Drug|Methotrexate|Induction Chemotherapy: 3mg/m2, Intravenous administration (pumping for 3h) on day 1 of each 3-week cycle until disease progression/stable disease or unacceptable toxicity develops, up to 6 cycles.
15764793|NCT04737889|Drug|Temozolomide|Induction Chemotherapy: 150mg/m2/d oral administration on day 1 to 10 of each 3-week cycle until disease progression/stable disease or unacceptable toxicity develops, up to 6 cycles.
15764794|NCT04737876|Biological|BX002-A|bacteriophage cocktail
15764795|NCT04737876|Other|Placebo|Placebo
15764796|NCT04737863|Procedure|Endodontic retreatment|Root canal retreatment in cases with secondary root canal infection
15764797|NCT04737850|Drug|Hetrombopag|Thrombopoietin receptor agonist
15764798|NCT04737850|Drug|Placebo|Placebo with no active pharmaceutical ingredient
15764799|NCT04737837|Drug|lacosamide|lacosamide as first add on therapy
15764800|NCT04737824|Procedure|"An adaptation of the balloon-blowing exercise"|The participants were positioned in supine, on a semi-rigid surface, with the upper limbs placed above the level of the head, at rest. Their feet were also placed at a resting position on a wall and with their hips and knees at 90o of flexion. The cervical was placed in a neutral position and the pelvis was maintained in a posterior pelvic tilt, both structures corrected by the researcher. The participants were asked to contract the adductors, maintaining a bilateral and symmetric pressure between 10 and 15 mmHg on two sphygmomanometers placed between the knees. Also, an isometric contraction of the hamstrings and gluteus was requested. A Threshold®, with a minimum resistance of 5 cmH2O, and they were instructed to close their lips around the mouthpiece, to avoid air leaks. To start the exercise, it was transmitted to the participants to make a maximum inspiration through the nose, for two seconds. Subsequently, a maximum exhalation throughout the threshold was made for three seconds.
15764849|NCT04737421|Device|NobelActive TiUltra implant|Subjects will be enrolled and treated with one of the above groups as per the their clinical requirement and standard of care of the clinic.
15764908|NCT04737018|Other|Postural Assessment Scale for Stroke|score from 0 to 36 measures the patient's ability to maintain stable postures and balance in changes of position
15764801|NCT04737824|Procedure|"An adaptation of the balloon-blowing exercise for seven weeks, three times a week, at home"|The participants were positioned in supine, on a semi-rigid surface, with the upper limbs placed above the level of the head, at rest. Their feet were also placed at a resting position on a wall and with their hips and knees at 90o of flexion. The cervical was placed in a neutral position and the pelvis was maintained in a posterior pelvic tilt, both structures corrected by the researcher. The participants were asked to contract the adductors, maintaining a bilateral and symmetric pressure between 10 and 15 mmHg on two sphygmomanometers placed between the knees. Also, an isometric contraction of the hamstrings and gluteus was requested. A Threshold®, with a minimum resistance of 5 cmH2O, and they were instructed to close their lips around the mouthpiece, to avoid air leaks. To start the exercise, it was transmitted to the participants to make a maximum inspiration through the nose, for two seconds. Subsequently, a maximum exhalation throughout the threshold was made for three seconds.
15764802|NCT04737811|Other|Turkish Version of Swallowing Disturbance Questionnaire|The Turkish Version of Swallowing Disturbance Questionnaire consists of 15 questions related with dysphagia.
15764803|NCT04737798|Other|oil pulling with coconut oil|using oil pulling therapy with coconut oil
15764804|NCT04737798|Other|oil pulling with sesame oil|using oil pulling therapy with sesame oil
15764805|NCT04737772|Behavioral|Behavioral: Quitline treatment as usual|TAU is state quitline treatment that may include coaching sessions, text messaging and access to the web-based program plus cessation medications and unlimited calls to the QL for support between sessions.
15764806|NCT04737772|Behavioral|QL Marijuana Check-Up intervention (QL-MJCU)|QL Marijuana Check-Up intervention (QL-MJCU) was developed for non-treatment seeking MJ users and is based on Motivational Enhancement Therapy. Includes TAU (see standard quitline arm) with a trained coach plus a MJ assessment and Personalized Feedback Report (PFR).
15764807|NCT04737759|Behavioral|Taking Care of Us|A social-behavioral intervention that is targeted at the couple living with heart failure and delivered via Zoom.
15764808|NCT04737759|Other|SUPPORT|SUPPORT is an educational counseling intervention that is targeted at the couple living with heart failure and delivered by Zoom.
15764809|NCT04737733|Other|The dementia friendly program|Implementation of a systematic screening and risk modification and management plan, to identify and enhance the management of patients with cognitive impairment and risk of delirium.
15764810|NCT04737707|Other|Dialectical Behavior Therapy (DBT)|Dialectical Behavior Therapy (DBT)
15764811|NCT04737694|Dietary Supplement|Ketone ester|Oral ketone ester + glucose supplement
15764812|NCT04737694|Dietary Supplement|Glucose|Glucose supplement
15764813|NCT04737681|Other|body composition|This is an observational study to determine immune response and skin barrier restoration in individuals with and without obesity.
15764814|NCT04737668|Other|Intrathecal pump refill with Virtual Reality|VR game
15764815|NCT04737668|Other|Intrathecal pump refill with distraction|Video
15764816|NCT04737668|Other|Intrathecal pump refill|daily routine care for pump refill
15764817|NCT04737655|Drug|TRIMBOW® pressurised inhalation solution: Beclometasone dipropionate / formoterol fumarate /glycopyrronium 87/5/9 µg per inhalation|Evaluate Trimbow associated with the standard of care in comparison with the standard of care alone.
15764818|NCT04737642|Procedure|Papillary ballon dilatation|Trans cystic papillary ballon dilatation during cholecystectomy
15764819|NCT04737629|Behavioral|Expectancy and Water|In the expectancy and water condition, participants will be instructed to consume the mint herb and 500mL of water before the start of the taste test. The script for this condition will inform them of research that has shown water to decrease appetite by up to 50% (attempting to create an expectancy).
15764820|NCT04737629|Behavioral|No Expectancy and Water|Participants will be instructed to consume the mint herb and 500mL of water before the start of the taste test. The script will inform them of research that has shown water to decrease appetite by up to 50%. In this condition, however, the research team will also inform them that this herb is expected to counteract the effects of water on appetite because it decreases water retention, causing water to pass through the stomach and intestines at a faster than normal rate (attempting to create no water expectancy or nullify any pre-existing expectancy).
15764821|NCT04737629|Behavioral|No Water|Participants will be instructed to consume the mint herb and 50mL of water before the start of the taste test. Participants will be given 100mL of water during the taste test to aid in their ability to taste and consume food, and to avoid acute thirst interfering with food consumption. Access to fluids during a taste test has been used in control conditions in similar studies. The script for this condition will inform participants of research that has shown water to decrease appetite by up to 50% but acknowledge that they will not be receiving water (thus, they should not expect an effect on appetite).
15764822|NCT04737616|Device|CO2 laser|Fractional CO2 vaginal laser for genitourinary syndrome of menopause
15764823|NCT04737616|Device|OCT|Optical coherence tomography endoscope
15764824|NCT04737603|Drug|ED-Initiated treatment with buprenorphine / naloxone|A Clinical Opiate Withdrawal Score (COWS) score will be administered, and an induction dose of buprenorphine when COWS scores >=8. Participants who weigh > 70 kg and/or reported using ≥ 3 bags of heroin/day or its prescription opioid equivalent will receive 4 mg. After 1 hour an additional 4 mg will be administered for a total of 8 mg. Participants who weigh <= 70 kg and/or reported using ≤ 3 bags of heroin/day or its prescription opioid equivalent will receive 4 mg of buprenorphine. After 1 hour, an additional 2 mg will be administered for a total of 6 mg. Patients will be prescribed sufficient take-home daily doses (one-week supply) to ensure that the patient has adequate medication to receive 12-16 mg buprenorphine sublingual once daily. Parents of adolescents will also receive appropriate education on how to administer medication. Home induction instructions will be provided to patients and parents that arrive to the ED after an opioid overdose.
15764825|NCT04737590|Device|Bioactive glass|Comparison of bioactive glass to allogenic bone in pediatric bone cysts
15764826|NCT04737577|Procedure|Supramarginal resection|Tissue removal beyond the GAD-enhancing region extending to either at least 1 cm into non-enhancing tissue, or the nearest non-enhancing sulcal boundary/ventricle wall if these structures are closer than 1 cm.
15764827|NCT04737577|Procedure|Conventional (i.e. GTR) resection|Planned resection of ≥95% of the GAD-enhancing regions of tumor without expanding the resection beyond this margin.
15764907|NCT04737018|Other|Modified Ashworth Scale|score from 0 to 4 evaluation of spasticity
15764828|NCT04737564|Behavioral|Attachment and Biobehavioral Catch-up (ABC10)|"The ABC parenting targets include: nurturing children when they are distressed (Sessions 1 and 2), following the child's lead in play (Sessions 3 and 4), and avoiding harsh or frightening behavior (Sessions 5 and 6). Sessions 7 and 8 help parents consider how their own experiences of being parented affect their sensitivity, and Sessions 9 and 10 consolidate gains with additional practice. Session content focusing on parenting targets is guided by a manual. Additionally, parent coaches make frequent in-the-moment comments (at least once per minute) about parent-child interactions as they occur in session, and use video feedback."
15764829|NCT04737564|Behavioral|Attachment and Biobehavioral Catch-up, Brief (ABC3)|The 3-session Attachment and Biobehavioral Catch-up intervention (ABC 3) is a brief version of the standard protocol. Parents who receive ABC 3 will receive the first 3 sessions of the ABC intervention, which focus on enhancing parental sensitivity (i.e., nurturance to distress, following the child's lead) by providing in-the-moment feedback on parent-child interactions, video feedback, and discussion of manualized content. ABC 3 was adapted from the standard protocol based on modeling of session-by-session data that demonstrated that, on average, most of the change in parental sensitivity happens in the first several sessions of the intervention.
15764830|NCT04737564|Behavioral|Safe Environment for Every Kid (SEEK)|Safe Environment for Every Kid (SEEK) is an evidence-based screening and referral system to facilitate parents' access to services for risk factors for maltreatment, including: mental health, substance abuse, intimate partner violence, harsh parenting, major parental stress, and food insecurity. Parents first complete the SEEK Parent Questionnaire with the help of an outreach worker. Following the SEEK protocol, handouts will be provided that address the identified problems and parents will be referred to partnering organizations in the community. Any additional work is completed by phone. The developer of the intervention, Howard Dubowitz, is a consultant on this application and will provide support around effective implementation.
15764831|NCT04737551|Other|Follow-up only|Only routine follow-up but no treatment
15764832|NCT04737551|Drug|Adjuvant chemotherapy|Chemotherapy regimens will be decided by physicians or MDT teams, basing on patients' physical status, income status, and/or desire. Toxicity was evaluated every cycle and efficacy was evaluated every two cycles. The treatment course of adjuvant chemotherapy was followed the recommendation of NCCN guideline.
15764833|NCT04737551|Radiation|Adjuvant chemoradiotherapy|"Adjuvant CRT could be delivered before or simultaneously with adjuvant chemotherapy. Radiation used 6 MV or 15 MVX-ray beams delivering daily fractions of 180-200cGy to a total dose of 45-55Gy in 25-28 fractions using CT-based, three-dimensional conformal radiation therapy (3DRT), intensity-modulated radiation therapy (IMRT) or tomotherapy (TOMO).
~S-1 was administered orally at a dose of 40mg twice a day during radiation day as radiosensitizer through radiotherapy. Antiemetic medications and proton pump inhibitor were prophylactic used to reduce the occurrence of nausea and inhibit gastric acid secretion."
15764834|NCT04737551|Radiation|Adjuvant chemoradiotherapy + Adjuvant chemotherapy|See as above (adjuvant chemotherapy and adjuvant chemoradiotherapy).
15764835|NCT04737538|Other|Experimental Dentrifrice|Toothpaste containing sodium bicarbonate, sodium hyaluronate and sodium fluoride
15764836|NCT04737538|Other|Positive control dentifrice|Dentifrice containing 67% w/w sodium bicarbonate and 0.221% w/w sodium fluoride
15764837|NCT04737538|Other|Negative control dentifrice|Dentifrice containing 1100ppm fluoride as sodium fluoride (Crest Cavity Protection)
15764838|NCT04737525|Device|Dental implant placement, bone and soft tissue augmentation on buccal site|"Atraumatic extraction
~Palatinal positioning of tapered implant (BLX) 3.75mm diameter
~3-4 mm below vestibular gingival line or 1 mm below bone crest
~Implant placement
~Allogenic bone packing of the jumping distance and soft tissue grafting
~Connective tissue graft (CTG) or porcine-derived membrane
~Provisional restoration out of occlusion and mandibular movements
~X-ray"
15764839|NCT04737512|Behavioral|Mindfulness-Based ADHD Treatment for Children|MBAT-C is derived from Mindfulness-Based Stress Reduction (MBSR), a well-known and extensively-studied mindfulness intervention. Unlike all other mindfulness-based interventions, however, MBAT-C is tailored to the needs, abilities, and vulnerabilities of children with ADHD through the use of age-appropriate class length, homework assignments, contemplative practices, and discussion topics.
15764840|NCT04737512|Biological|Goal-Standard Medication (Treatment as Usual)|"Participants will receive gold-standard, non-experimental medication. This treatment arm relies on a step-by-step approach that is designed to mimic pharmacologic treatment-as-usual in the community. The treatment algorithm is as follows:
~All participants will start with Concerta; Ritalin may be started if the effect of Concerta wears off mid-day;
~If Concerta +/- Ritalin is ineffective or not tolerated, participants will progress to Vyvanse; Adderall may be started if the effect of Vyvanse wears off mid-day;
~If Vyvanse +/- Adderall is also ineffective or not tolerated, participants will progress to Kapvay;
~If Kapvay is ineffective or not tolerated, participants will progress to Intuniv.
~Alternative combinations of the above medications will be considered if the above combinations are ineffective or otherwise not tolerated."
15764841|NCT04737499|Behavioral|CASCADe|Culturally tailored diabetes self-management and education sessions with mHealth integration
15764842|NCT04737486|Drug|AV-001|AV-001 (mpaBr) Cl for Injection 2.5 mg/mL
15764843|NCT04737486|Other|Placebo|D-PBS
15764844|NCT04737473|Drug|Opiod Free Anesthesia|The OFA protocol will entailed induction of anesthesia intravenously by the administration of the following drugs: magnesium sulfate 40mg/kg (without exceeding 2.5g), lidocaine 1.5mg/kg, ketamine 25mg, propofol 1.5-2mg/kg, dexamethasone 8mg and rocuronium
15764845|NCT04737460|Genetic|AAV9/CLN7|Enrollees will receive gene therapy via a viral vector
15764846|NCT04737447|Device|Whole Body Vibration Training|Galileo® Trainer is a vibration board. The movement alternating to different sides during walking correlates with the movement on the board due to variable amplitudes and frequencies. Movements of the vibration board are quickly changing and thus simulating the tilting movements of the pelvic during walking but with higher frequency. Muscles of legs and core are activated reflexively. In our study there are performed static practices and pelvic activating practices. Each physiotherapist is experienced in the technical and practical handling of the device.
15764847|NCT04737434|Device|Extremely low frequency electromagnetic field device|with extremely low frequency electromagnetic wave deliver or not to participants during sleep.
15764848|NCT04737434|Device|electromagnetic field with no wave|electromagnetic field with no wave
15764961|NCT04736693|Drug|Zoledronic Acid|Zoledronic Acid dispensing claim is used as the exposure group.
15764850|NCT04737421|Device|NobelParallel CC TiUltra implants|Subjects will be enrolled and treated with one of the above groups as per the their clinical requirement and standard of care of the clinic.
15764851|NCT04737421|Device|NobelReplace CC TiUltra implants|Subjects will be enrolled and treated with one of the above groups as per the their clinical requirement and standard of care of the clinic.
15764852|NCT04737421|Device|Nobel Biocare N1 TiUltra TCC implants|Subjects will be enrolled and treated with one of the above groups as per the their clinical requirement and standard of care of the clinic.
15764853|NCT04737408|Drug|Rosuvastatin 40mg|Rosuvastatin 40 mg
15764854|NCT04737395|Device|"upper extremity training program (Meditouch,MSQUARE)"|40 hours of therapy with the Hand Tutor (MediTouch) device and a wearable vest (EkssoUE, Ekso Bionics) for arm rehabilitation
15764855|NCT04737382|Diagnostic Test|biopsy|The formalin fixed material will be processed for molecular analysis in a clinically validated diagnostic pipeline according to ISO 15189 or other acceptable standard
15764856|NCT04737382|Diagnostic Test|ctDAN analysis|ctDNA analysis will be performed using the AVENIO ctDNA targeted kit according to the guidelines from the manufacturer with respect to isolation, library preparation and bioinformatics analysis.
15764857|NCT04737356|Behavioral|Cognitive behavior therapy|Internet-based CBT intervention based on CBT theory as well as self-determination therapy for low self-esteem among adolescents.
15764858|NCT04737343|Drug|Leflunomide|Patient will be treated with Leflunomide(Tuoshu, the commericial name) 30mg QD for 18 months
15764859|NCT04737343|Drug|Azathioprine Tablets|Patients included into this study will be treated with Azathioprine tablets 100mg QD for 18 months.
15764862|NCT04737317|Diagnostic Test|ECG, Echo, laboratory tests, CMR, PET-CT, Biopsy|ECG - 12 leads ECG Echo: transthoracic echocardiography laboratory tests: full blood count, electrolytes, creatinine, high sensitive cardiac troponin T, angiontesin converting enzyme, soluble interleukin-2 receptor, cardiac magnetic resonance imaging: 1.5 Tesla scanner, Conventional cine imaging and late gadolinium enhancement imaging PET-CT: 18F-fluorodeoxyglucose (FDG)- positron emission tomograph Biopsy: cardiac biopsy = endomyocardial biopsy, left and right ventricle, at least 5 specimens in formaldehyd and 3 specimens for testing of infectious agents Biopsy: extracardiac biopsy, as accessible according to imaging
15764863|NCT04737304|Drug|BEN2293 (0.25% or 1.0% w/w) or matching placebo|BEN2293 and placebo will be administered as a topical ointment. Both ointments contain the same excipients; placebo ointment has been manufactured in the same way except for the addition of 0.25% and 1.0% (w/w) BEN2293.
15764864|NCT04737291|Device|drug coated balloon|use of drug coated balloon in treatment of critical limb ischemia
15764865|NCT04737278|Drug|Cunermuspir|"Copper Niacin Chelate, 6.06 mg per capsule Non-medicinal ingredients:
~Organic evaporated cane juice powder, hypromellose, titanium dioxide"
15764866|NCT04737278|Other|Placebo|same non-medical ingredients and encapsulation as Intervention 1
15764868|NCT04737252|Behavioral|Connecting, Overcoming and Moving Past Suicide and Self-Injury|COMPASS is a remote 8-12 session intervention for couples wherein one individual has Borderline Personality Disorder (BPD) and engages in self-injury thoughts and behaviours. The intervention consists of elements of Cognitive Behavioural Conjoint Therapy (CBCT) and has been adapted for this population. Couples will meet remotely with a clinician (registered psychologists and/or graduate level clinicians) for 8-12 sessions via Zoom Healthcare. The primary outcomes are self-injury thoughts and behaviours (as measured by the Suicide Attempt and Self-Injury Interview-modified, and the Beck Scale for Suicidal Ideation and ecological momentary assessment) and borderline personality disorder symptoms (as measured by the Borderline Symptom List-23).
15764869|NCT04737239|Other|Corticosteroid injections for CTS treatment|Treatment of carpel tunnel syndrome with corticosteroid injections for EMG mild and EMG negative patients
15764870|NCT04737226|Diagnostic Test|myotonometric assessment|The measurement method of the device is based on the free oscillation technique. Firstly, the probe of the device is placed perpendicular to the skin and a pre-pressure is applied to compress the subcutaneous tissue. Then, a short mechanical impulse is applied, causing damped oscillation on the tissue and the co-oscillation is recorded by an accelerometer.
15764871|NCT04737226|Diagnostic Test|Ankle mobility assessment|The knee to wall lunge test will use in a standing position while the heel in contact with the ground and the knee was in line with second toe. Athletes will do lunge forward and inclinometer will be place at the middle anterior tibial crista and measurement will be record.
15764872|NCT04737213|Drug|SGM-101|Fluorescence guided surgery
15764873|NCT04737200|Dietary Supplement|Time-of-day of enteral nutrition provision (daytime first)|Enteral nutrition (tube feeds) will be provided during the daytime followed by nighttime.
15764874|NCT04737200|Dietary Supplement|Time-of-day of enteral nutrition provision (nighttime first)|Enteral nutrition (tube feeds) will be provided during the nighttime followed by daytime.
15764875|NCT04737187|Drug|Trifluridine/Tipiracil|Taken by mouth two times a day, 5 days on/2 days off, over 2 weeks, followed by a 14-day rest
15764876|NCT04737187|Drug|Bevacizumab|administered every 2 weeks (Day 1 and Day 15)
15764877|NCT04737174|Drug|ES-481|28-day screening period followed by 4-week dose escalation period followed by 16-week treatment period followed by 4-week dose washout period
15764878|NCT04737161|Biological|T regulatory cells|T regulatory cells isolated by immunomagnetic selection; donor cells collected through large volume apheresis.
15764879|NCT04737148|Other|Mortality scores|Revised Baux, BOBI and FLAMES scores
15764880|NCT04737135|Other|Non intervention|Patients without intervention
15764881|NCT04737122|Drug|LM-061|The subjects in each dose level will be administered single oral dose of LM-061 tablet on C0D1, and washout for 5 days. After that, the subjects will be administered multiple oral doses once daily (QD) in continuous 28 days (4 weeks) per treatment cycle, until meet the treatment termination criteria, including disease progression or unaccepted toxicity, etc. After obtaining MTD/RP2D, the Safety Review Committee (SRC) may combine the data of safety, PK, and preliminary efficacy to explore other dosing schedules (such as 3 weeks on and 1 week off).
15764882|NCT04737122|Drug|LM-061|The subjects in each dose level will be administered single oral dose of LM-061 tablet on C0D1, and washout for 5 days. After that, the subjects will be administered multiple oral doses once daily (QD) in continuous 28 days (4 weeks) per treatment cycle, until meet the treatment termination criteria, including disease progression or unaccepted toxicity, etc. After obtaining MTD/RP2D, the Safety Review Committee (SRC) may combine the data of safety, PK, and preliminary efficacy to explore other dosing schedules (such as 3 weeks on and 1 week off).
15764883|NCT04737122|Drug|LM-061|The subjects in each dose level will be administered single oral dose of LM-061 tablet on C0D1, and washout for 5 days. After that, the subjects will be administered multiple oral doses once daily (QD) in continuous 28 days (4 weeks) per treatment cycle, until meet the treatment termination criteria, including disease progression or unaccepted toxicity, etc. After obtaining MTD/RP2D, the Safety Review Committee (SRC) may combine the data of safety, PK, and preliminary efficacy to explore other dosing schedules (such as 3 weeks on and 1 week off).
15764884|NCT04737122|Drug|LM-061|The subjects in each dose level will be administered single oral dose of LM-061 tablet on C0D1, and washout for 5 days. After that, the subjects will be administered multiple oral doses once daily (QD) in continuous 28 days (4 weeks) per treatment cycle, until meet the treatment termination criteria, including disease progression or unaccepted toxicity, etc. After obtaining MTD/RP2D, the Safety Review Committee (SRC) may combine the data of safety, PK, and preliminary efficacy to explore other dosing schedules (such as 3 weeks on and 1 week off).
15764885|NCT04737122|Drug|LM-061|The subjects in each dose level will be administered single oral dose of LM-061 tablet on C0D1, and washout for 5 days. After that, the subjects will be administered multiple oral doses once daily (QD) in continuous 28 days (4 weeks) per treatment cycle, until meet the treatment termination criteria, including disease progression or unaccepted toxicity, etc. After obtaining MTD/RP2D, the Safety Review Committee (SRC) may combine the data of safety, PK, and preliminary efficacy to explore other dosing schedules (such as 3 weeks on and 1 week off).
15764886|NCT04737122|Drug|LM-061|The subjects in each dose level will be administered single oral dose of LM-061 tablet on C0D1, and washout for 5 days. After that, the subjects will be administered multiple oral doses once daily (QD) in continuous 28 days (4 weeks) per treatment cycle, until meet the treatment termination criteria, including disease progression or unaccepted toxicity, etc. After obtaining MTD/RP2D, the Safety Review Committee (SRC) may combine the data of safety, PK, and preliminary efficacy to explore other dosing schedules (such as 3 weeks on and 1 week off).
15764887|NCT04737122|Drug|LM-061|The subjects in each dose level will be administered single oral dose of LM-061 tablet on C0D1, and washout for 5 days. After that, the subjects will be administered multiple oral doses once daily (QD) in continuous 28 days (4 weeks) per treatment cycle, until meet the treatment termination criteria, including disease progression or unaccepted toxicity, etc. After obtaining MTD/RP2D, the Safety Review Committee (SRC) may combine the data of safety, PK, and preliminary efficacy to explore other dosing schedules (such as 3 weeks on and 1 week off).
15764891|NCT04737096|Drug|DAOIB|The DAOIB dose will be adjusted every 8 weeks according to clinical evaluation.
15764892|NCT04737096|Drug|Placebo|placebo
15764893|NCT04737096|Device|tDCS|tDCS
15764894|NCT04737083|Genetic|CGH array|a CGH array is systematically offer to women when the fetus show bilateral clubfoot during prenatal ultrasound screening
15764895|NCT04737070|Biological|Prenatal test for Trisomy 21 screening|prenatal routine test for Trisomy 21 screening (blood test + nuchal translucency test)
15764896|NCT04737057|Procedure|SDF|Apply this topical medication through : 1)Dry with a gentle flow of compressed air to decayed tooth surfaces. 2) Bend micro sponge brush to remove excess liquid before application apply SDF directly to only the affected tooth surface. 3) Apply the SDF material 4)Dry with a gentle flow of compressed air for at least one minute. and Remove excess SDF with gauze
15764897|NCT04737057|Procedure|Hall technique|this technique is performed through :1) Orthodontic separator being stretched between two pieces of floss, then placed between the contact points of primary molars (for five days.) 2)The correct size of crown will not impinge on the teeth on either side, and a slight 'spring back' will be felt when the PMC is gently pushed up to (but not through) the contact points and the PMC has been filled with a Riva self-cure capsule cement, extruded cement is quickly wiped away and the child is asked to keep biting on the crown for two minutes, until the cement is set, to prevent 'spring back' of the PMC from the fully seated position
15764898|NCT04737044|Other|Study 1: MRBS|MRBS as added sugar based on their habitual diet
15764899|NCT04737044|Other|Study 2: White sugar & education module|White sugar for daily usage (<10% daily energy intake)
15764900|NCT04737044|Other|Study 2: MRBS & education module|MRBS for daily usage (<10% daily energy intake)
15764901|NCT04737031|Other|Clinician Nudge|"Investigators will use the Best Practice Alert functionality within the EMR as the conduit to the point of decision-making. Epic currently fires a BPA for each new patient presenting to ACC within the Medical Assistant check-in and vital sign workflow, requiring that medical assistants assess tobacco use status within the past 30 days and satisfy the alert with one of three possible answers. Upon opening the Epic Order tab at a patient's next Repeat Visit after the Index Visit, clinicians will receive the implementation strategy, placed directly over the order interface. The clinician will be required to acknowledge or opt-out when presented with the order. Opting-out will require clinicians to acknowledge a reason for opt-out using a checklist or free text. Upon a clinician's decision to opt-out, the BPA will fire at up to two subsequent Repeat Visits."
15764902|NCT04737031|Other|Patient Nudge|Patients will receive a message sent through myPennMedicine following establishment of their smoking status (at the Index Visit). In all cases, the message will include information specific to the upcoming appointment with the oncology clinician (next Repeat Visit).
15764903|NCT04737018|Other|Fugl-Meyer Assessment (FMA)|assessment of motor skills : measurement of the intensity of reflexes, as well as an assessment of voluntary movements and motor coordination Score from 0 to 34
15764904|NCT04737018|Other|Medical Research Concil (MRC)|evaluation of muscular strength score from 0 to 5
15764905|NCT04737018|Other|2 Minute Walk Test (2MWT)|Assess functional walking and aerobic abilities
15764906|NCT04737018|Other|Timed Up & Go Test|measures the time it takes to get up from a chair, walk 10 feet, turn around, return to the seat and sit down
15764909|NCT04737018|Device|posturographic recording|analysis of static equilibrium parameters and positional measurement of the center of gravity on the Winposturo platform
15764910|NCT04737018|Other|vibration program|a 4-week program of muscular focal vibrations, at the rate of 5 sessions of 30 minutes per week, in addition to conventional rehabilitation. The program will apply a frequency of 100 Hz, with an amplitude of 1 mm
15764911|NCT04737018|Other|sham program|a 4-week program of muscular focal vibrations, at the rate of 5 sessions of 30 minutes per week, in addition to conventional rehabilitation.
15764912|NCT04737005|Procedure|Nano-ceramic hybrid (Grandio Blocs) Endo-crown|Nano-ceramic hybrid
15764913|NCT04736992|Other|No intervention involved|No intervention involved
15764914|NCT04736979|Drug|amoxicillin clavulanate|dosage according to Shariff score and creatinine clearance
15764915|NCT04736966|Drug|Guselkumab 30mg|30mg of Guselkumab administered by subcutaneous injection
15764916|NCT04736966|Drug|Guselkumab 70mg|70mg of Guselkumab administered by subcutaneous injection
15764917|NCT04736966|Drug|Guselkumab 100mg|100mg of Guselkumab administered by subcutaneous injection
15764918|NCT04736953|Drug|Sirolimus|Sirolimus
15764919|NCT04736953|Other|Placebo|Placebo
15764920|NCT04736927|Drug|GLPG3667|From Day 3 to Day 8, GLPG3667 capsules q.d. orally in fed state.
15764921|NCT04736927|Drug|Midazolam|On Day 1 and Day 7 as liquid formulation, orally in fed state.
15764922|NCT04736914|Drug|R-CHOP/R-DHAOx； Zanubrutib（induction）； ASCT conditioning ； Zanubrutinib（Maintenance）|"Alternating 3× R-CHOP/ 3× R-DHAOx, every 21 days plus oral Zanubrutinib in cycle 1, 3, 5 in combination with R-CHOP:
~R-CHOP (cycle 1,3,5):
~Rituximab 375 mg/m2 D1, I.V. Cyclophosphamide 750 mg/m2 D1, I.V. Doxorubicine 50 mg/m2 D1, I.V. Vincristine 1.4mg/m2(max 2mg)D1, I.V. Prednisone 100mg D1-5, oral Zanubrutinib 160mg BID D1-21, oral
~R-DHAOx (cycle 2,4,6):
~Dexamethasone 40mg D1-4 oral/I.V. Rituximab 375mg/m2 D1, I.V. Ara-C 2×2g/m2 q12h D2, I.V. Cisplatin 100mg/m2 D1, I.V.
~Maintenance:
~Zanubrutinib, 160mg PO BID, continuously for 2 year or until progressive disease。
~Zanubrutinib maintenance will start after regeneration of peripheral blood count after the end of the last cycle of induction therapy or ASCT"
15764923|NCT04736901|Drug|Enoxaparin|0.5 mg/kg every 12 hours
15764924|NCT04736901|Drug|Enoxaparin|40 mg/day
15764925|NCT04736901|Drug|Rivaroxaban|10 mg once daily
15764926|NCT04736901|Drug|Rivaroxaban|20 mg once daily
15764927|NCT04736901|Drug|Apixaban|2.5 mg twice daily
15764928|NCT04736901|Drug|Apixaban|5 mg twice daily
15764929|NCT04736888|Other|extended-reality CPR training|extended-reality technologies based CPR training module
15764930|NCT04736888|Other|conventional CPR training|conventional CPR training with video
15764931|NCT04736875|Diagnostic Test|Doppler ultrasound study|Transcutaneous Doppler ultrasound (DUS) study was performed at the mid brachial artery to assess diameter, VF and RI, and at the mid segment of the efferent vein to assess the diameter and wall thickness.
15764932|NCT04736862|Device|Continuous non-invasive blood pressure monitoring|In patients randomized to the continuous monitoring group, continuous non-invasive finger-cuff blood pressure monitoring will be displayed on the patient monitor. The treating anesthesiologist will be blinded to intermittent blood pressure monitoring using upper-arm cuff oscillometry.
15764933|NCT04736862|Device|Intermittent non-invasive blood pressure monitoring|In patients randomized to the intermittent monitoring group, intermittent blood pressure monitoring using upper-arm cuff oscillometry will be displayed on the patient monitor. The treating anesthesiologist is blinded to continuous non-invasive finger-cuff blood pressure monitoring.
15764935|NCT04736836|Drug|Rifaximin|locally absorbed antibiotic
15764936|NCT04736823|Drug|AK112|IV infusion
15764937|NCT04736823|Drug|Pemetrexed|IV infusion
15764938|NCT04736823|Drug|Paclitaxel|IV infusion
15764939|NCT04736823|Drug|Carboplatin|IV infusion
15764940|NCT04736823|Drug|Docetaxel|IV infusion
15764941|NCT04736823|Drug|AK105|IV infusion
15764942|NCT04736810|Biological|AK105|IV infusion
15764943|NCT04736810|Drug|Cisplatin|IV infusion
15764944|NCT04736810|Drug|Gemcitabine|IV infusion
15764945|NCT04736810|Drug|Anlotinib hydrochloride|Oral administration
15764946|NCT04736784|Other|Food-based - beetroot juice|Beetroot juice containing approximately 340 mg nitrate daily
15764947|NCT04736784|Other|Food-based - leafy green vegetable juice|Leafy green vegetable juice containing approximately 340 mg nitrate daily
15764948|NCT04736758|Drug|GP681 tablet|influenza subjects is randomized 1:1:1 into GP681 tablet 40mg group,GP681 tablet 20mg group and Placebo group,with 72 patients in each group.subjects is given with GP681 tablet or GP681 Simulant only once to treat influenza.
15764949|NCT04736758|Drug|GP681 Simulant|influenza subjects is randomized 1:1:1 into GP681 tablet 40mg group,GP681 tablet 20mg group and Placebo group,with 72 patients in each group.subjects is given with GP681 tablet or GP681 Simulant only once to treat influenza.
15764950|NCT04736745|Biological|IPN59011|Powder and solvent for solution for injection
15764951|NCT04736745|Biological|Azzalure|Powder for solution for injection
15764952|NCT04736745|Drug|Placebo|Powder for solution for injection
15764953|NCT04736732|Other|Medical follow-up|Patients will be followed for medical evaluation and for biobanking of data and biological samples.
15764954|NCT04736719|Drug|Apixaban|Apixaban dispensing claim is used as the exposure group
15764955|NCT04736719|Drug|Warfarin|Warfarin dispensing claim is used as the reference group
15764960|NCT04736693|Drug|Raloxifene|Raloxifene dispensing claim is used as the reference group.
15764968|NCT04736602|Drug|Triptorelin pamoate 15mg|Intramuscular injection (IM)
15764969|NCT04736589|Drug|Inetetamab|Initial dose of 8mg/kg, completed in 90 minutes IV infusion, and then 6 mg/kg over 30-90 minutes IV infusion every 3 weeks.
15764970|NCT04736589|Drug|Rapamycin|Oral 2mg, once a day.
15764971|NCT04736589|Drug|Pyrotinib|Oral 400mg, once a day.
15764972|NCT04736589|Drug|Chemotherapy|Chemotherapy drugs are not limited in this trial, please refer to their instructions for specific usage.
15764973|NCT04736576|Device|Wearable device|As a low-interventional procedure, enrolled patients will be provided with wearable device and requested to wear the device at all-times, except of while bathing and sleeping, for 6 cycles (24 weeks).
15764974|NCT04736563|Device|Joint and muscle gel Puressentiel|To evaluate the antalgic effect in patients with chronic pain related to osteoarthritis of the knee when applied to the skin of Puressentiel Joints and Muscles - Gel with 14 essential oils.
15764975|NCT04736550|Behavioral|Exercise|"Participants who are randomized to exercise will be perform exercise on stationary bikes. Participants randomized to Voluntary Exercise will exercise on a standard stationary bike where they will pedal at their voluntary rates. Participants randomized to Assisted Exercise will exercise on a special bike that assists them to pedal faster than they do voluntarily on their own (assisted (exercise) bike)."
15764976|NCT04736550|Behavioral|Psychotherapy for Pain (I-STOP)|"Participants who are randomized to receive I-STOP will receive the Self-regulation Treatment for Opioid addiction and Pain (STOP) program modified for inpatients/residential drug treatment (I-STOP). I-STOP uses empirically validated pain psychotherapy approaches targeted to patients with an OUD using psycho-physiological self-regulation components and biofeedback with Bio-dots."
15764977|NCT04736537|Device|4DCT|CT imagining conceptually similar to time-lapse photography.
15764978|NCT04736524|Other|Rapid antibody test|Serial serology tests on day 21, 90, 180 and 365 following the first dose of the COVID-19 vaccine to detect the temporal trend of the IgM and IgG production in response to the vaccination.
15764979|NCT04736511|Other|Star Excursion Balance Test|"The subject will be in unipodal support (only one foot on the ground) on the tested lower limb in the center of the platform. Three lines forming a Y will be arranged according to the lower limb in charge in three directions : anterior (ANT), posteromedial (PM) and posterolateral (PL). The goal is then to reach the longest distance possible in all three directions with the tip of the foot in relief before returning to the starting position. The subject will have 4 training trials per direction on each lower limb then 3 trials will be recorded in order to keep the average."
15764980|NCT04736511|Other|Single leg Drop Vertical Jump|The subject will drop from a step and land on one leg, then jump as high as possible and stabilize again on the same leg. The height of the step is 30 cm. The subject will perform 3 consecutive jumps in the strictest respect of the instructions: drop to the level of the mark on the ground and bounce as high as possible while spending a minimum of time on the ground. The subject must stabilize for 3 seconds during the second contact with the ground so that the instructions and measurements are reproducible.
15764981|NCT04736511|Other|Unplanned sidestep cutting manoeuvre|"The objective is to create an unanticipated playing situation, close to the daily actions of the subjects in the practice of handball. The subject will make sidestep cutting manœuvre in front of an opponent simulated by a dummy used during usual training.
~The subject will sprint in a straight line and then at the force platform will make a rapid change of direction on the side of his shooting arm or will continue his run in a straight line. A light signal randomly will indicate to the player the direction in which he must carry out his manoeuvre. A computer reconstruction of the kinematics and dynamics (knee moment) will be performed."
15764982|NCT04736511|Other|Tendon vibration|The subject will be asked to stand, motionless in bipodal (both feet on the ground) support on a stable and unstable ground (foam). A tendon vibration (80Hz) will be randomly applied to the subject in the Achilles tendons or paravertebral muscles. This vibration will cause an alteration of proprioceptive information in the vibrated area leading to a disruption of postural balance. Thus, according to the amount of displacement of the center of pressure (CoP), the proprioceptive weighting ratio (dRPW) is calculated to deduce therefrom the weight assigned by the CNS to the various proprioceptive inputs during the postural task.
15764983|NCT04736498|Other|Inferior venacava Ultrasonography (IVC USG) guided fluid management|The IVC will be visualized using a paramedian long-axis view via a subcostal approach. A two-dimensional image of the IVC as it enters the right atrium will be first obtained. Variations in IVC diameter with respiration will be assessed using M-mode imaging performed 2 to 3 cm distal to the junction of right atrium and IVC. Maximum and minimum diameter will be measured from inner wall to inner wall and collapsibility index(CI) will be calculated using formula: CI = [(dIVCmax - dIVCmin)/dIVCmax] x 100% CI of ˃36% will be accepted as predicted fluid responder and ≤36% will be regarded as predicted fluid non responders. Predicted fluid responders will receive a bolus of 500 ml of Ringer's lactate over a time period of 15 min, after which the IVC diameter variation will be reassessed. Additional 250ml of Ringer's lactate bolus will be applied until a non fluid responder pattern is observed during IVC USG. Thereafter,spinal anaesthesia will be performed.
15764984|NCT04736485|Drug|perioperative treatment|FLOT + Spartalizumab
15764985|NCT04736472|Device|Pharmacogenetic test|Patients with reduced function alleles (DPYD intermediate or poor metabolizer and/or UGT1A1 poor metabolizer) will be recommended to receive dose reductions per clinical pharmacogenetic guidelines. Patients that do not carry actionable alleles (DPYD normal metabolizer and/or UGT1A1 normal or intermediate metabolizer) will receive standard dosing.
15764986|NCT04736459|Procedure|Pre-washed catheter vs. Unwashed catheter in the intrauterine insemination|The pre-washed catheter will be washed with culture medium before intrauterine insemination The unwashed catheter will not be washed with culture medium as a standard intrauterine insemination procedure
15764987|NCT04736446|Device|I-gel® supraglottic device|Use of an i-gel® supraglottic device to deliver ventilations
15764993|NCT04736407|Other|Observational sampling of CSF timed around routine clinical repositioning, or not|no true intervention
15764994|NCT04736394|Drug|APL-1202|APL-1202 single-agent oral treatment
15764995|NCT04736394|Drug|Epirubicin Hydrochloride|Epirubicin hydrochloride
15764996|NCT04736381|Drug|Belatacept Injection [Nulojix]|Drugs administrated are part of the usual care
15764997|NCT04736368|Other|EDIP Diet Suggestions|CD participants will receive EDIP diet suggestions after random allocation.
15764998|NCT04736368|Other|diet guidance|Control group will be given diet guidance according to routine experience under the participant's request.
15764999|NCT04736355|Drug|DAOIB|oral, for 24 weeks
15765000|NCT04736355|Drug|Placebo|oral, for 24 weeks
15765001|NCT04736342|Other|PALI questionaire|Survey comprised of a series of multiple choice questions
15765002|NCT04736329|Drug|Telmisartan|Telmisartan (20 up to 80mg) for RAAS inhibition, as part of heart failure therapy.
15765003|NCT04736316|Behavioral|Early CCLAD|Community-based client led antiretroviral therapy delivery groups.
15765004|NCT04736303|Device|BIS|The implementation of BIS monitoring
15765005|NCT04736290|Other|NLR|Calculation of NLR
15765006|NCT04736290|Other|PLR|Calculation of PLR
15765007|NCT04736277|Other|Preoperative HbA1c|Documentation of the preopetative HbA1c in patients undergoing noncardiac surgery under general anesthesia
15765008|NCT04736264|Other|Visual rehabilitation module: navigation and mobility|The visual rehabilitation regime consist of education and activity include dressing, feeding, personal hygiene and grooming activities, functional mobility, room orientation and memory, reading, eye hand coordination and also optokinetic training programme. A diary will be given to assess their compliance. Reassessment based on the number of fall, stumble etc when they go through a maze (developed in Phase 1)will be done every 2weeks for 8 weeks (4 times), every 4 weeks for next 8 weeks (2 times) and the final assessment 8 weeks later. A total study intervention will be 24 weeks
15765009|NCT04736264|Other|Visual rehabilitation module: exercise|An instruction course will be conducted and a CD (with step by step exercise demonstration) will be given to the patients in group A. They will be asked to come for another session in 2 weeks. Then they will be asked to conduct the exercise for at least three times a week for 24 weeks. Exercise diary and accelerometer will also be given to patients of both groups. They will be seen in the clinic every 8 weeks.
15765010|NCT04736264|Other|Visual rehabilitation module: reading|Patient in intervention group will be asked to complete a reading task (reading the given book) a day, number of pages completed in an hour per day and time taken to complete a page in given book. They are asked to complete the books within 24 weeks with follow up every 8 weeks.
15765011|NCT04736238|Procedure|Arthroscopy surgery|The patient receives intraspinal anesthesia or general anesthesia under supine position. Establish an anteromedial channel at the inner side of the tibial anterior tibial tendon at the level of the tibiotalar joint, and establish an anterolateral channel at the lateral angle of the talus. Exploring and clearing the ankle joint and dealing with possible combined injuries, such as talar cartilage injury, ankle impingement, and loose ankle joints. Then observe the lateral sulcus through the anterior medial channel, clean the synovium in the lateral sulcus, and explore the anterior talofibular ligament. A double-line anchor was inserted into the fibula side stop of the anterior talofibular ligament through the anterolateral channel. The anterior talofibular ligament was sutured using an outside-in technique in the anterior inferior safety zone of the distal end of the fibula. Fix the ankle joint with the suture after the dorsiflexion, neutral valgus position.
15765012|NCT04736238|Procedure|BrostrÖm surgery|The patient receives intraspinal anesthesia or general anesthesia under supine position. The first ankle arthroscopy is performed to deal with possible combined injuries, such as talar cartilage injury, ankle impingement, and loose ankle joints. Then, open surgery was performed, and an arc incision was made at the anterior edge of the lateral malleolus to the tip of the fibula. After separating the subcutaneous tissue, the anterolateral joint capsule and talofibular ligament are exposed. A double-line anchor was placed at the fibular side stop of the anterior talofibular ligament. Tighten and suture the anterior talofibular ligament, anterolateral joint capsule, and extensor support belt with an anchor band. Fix the ankle joint with the suture after the dorsiflexion, neutral valgus position.
15765013|NCT04736225|Other|Insulin Self-Titration Education Program|The program contents of instruction included blood glucose self-monitoring, types of insulin, insulin self-administration, insulin dose titration, hyperglycemia or hypoglycemia self-management, diet, and exercise.a 20-min one-on-one training session from a nurse on how to self-titrate the insulin dose. The participants were taught to monitor their before-breakfast and before-dinner blood glucose levels at home and adjust their insulin doses accordingly.
15765014|NCT04736212|Device|Bed sensor monitoring system|Respiratory patterns in the post-anesthesia care unit will be assessed using a validated, modified under bed weighing scale placed under the patient's bed in the PACU.
15765018|NCT04736186|Drug|Loperamide|Loperamide 4 mg， t.i.d.(d 1-7);4 mg, b.i.d.(d 8-21)
15765019|NCT04736186|Drug|Loperamide and golden bifid|Patients with secondary prevention will be randomly assigned to B：Loperamide 4 mg， t.i.d.(d 1-7);4 mg, b.i.d.(d 8-21)+golden bifid 2 g t.i.d.
15765020|NCT04736186|Drug|Loperamide and montmorillonite powder|Patients with secondary prevention will be randomly assigned to D：Loperamide 4 mg， t.i.d.(d 1-7);4 mg, b.i.d.(d 8-21)+montmorillonite powder 3 g t.i.d.
15765149|NCT04735328|Behavioral|LOCI|LOCI includes training of leaders in general leadership, implementation leadership, and implementation climate.
15765026|NCT04736160|Other|collect data|The data for this project will be obtained directly from the IVI digital work platform (SIVIS) where the characteristics and scans performed to each patient are recorded. Furthermore, it will be recollected information from the time-lapse incubator. For the current study will be used Embryoscope and Geri time-lapse incubators
15765027|NCT04736147|Biological|JNJ-64300535|JNJ-64300535 injection will be administered intramuscularly.
15765028|NCT04736134|Biological|BMS-986326|Specified dose on specified days
15765029|NCT04736134|Other|Placebo matching BMS-986326|Specified dose on specified days
15765031|NCT04736108|Drug|Abiraterone acetate|1000 mg orally daily for 24 weeks before radical prostatectomy
15765032|NCT04736108|Drug|Prednisolone|5 mg oral low dose prednisone, once daily
15765033|NCT04736108|Drug|Goserelin|10.8 mg goserelin hypodermic once per 12 weeks
15765034|NCT04736095|Diagnostic Test|3D Ultrasound|Doing 3D ultrasound for diagnosis of submucous myoma
15765035|NCT04736095|Diagnostic Test|Hysteroscopy|Doing hysteroscopy for diagnosis of submucous myoma
15765036|NCT04736082|Other|Intervention Group: Infant Formula with hydrolyzed protein|Infants will receive infant formula during the first 120 days of life with optional follow up until 180 days of life (intervention formula manufactured from extensively hydrolysed whey protein).
15765037|NCT04736082|Other|Control Group: Infant Formula with intact protein|Infants will receive infant formula during the first 120 days of life with optional follow up until 180 days of life (control formula manufactured from intact cow's milk protein).
15765038|NCT04736069|Other|Physical therapy program|In the physical therapy program, 20 minutes of hot pack, 20 minutes of transcutaneous electrical nerve stimulation (TENS; 30 to 40 Hz), 6 minutes of ultrasound (US; 1 MHz, 1 to 1.5 Watt/cm2) therapy were applied to both groups. Both of the programs were supervised by physical therapists. A combined range of motion and strengthening exercises were given to both groups to be performed two times a day.
15765039|NCT04736056|Behavioral|Mindfulness-Based Therapy for Insomnia with Cognitive-Behavioral Symptom Coping Skills|Mindfulness-based sleep strategies and cognitive-behavioral symptom coping skills.
15765040|NCT04736043|Other|Organoid|The investigators create organoid from the pancreatic cancer tissue obtained via EUS-FNA and EUS-FNB within the pancreatic cancer diagnostic process. And also the investigators create organoid from the pancreatic cancer tissue obtained after surgery as part of the pancreatic cancer treatment process. Check for the reactivity to anti-cancer drugs through cell viability assay after treating with various anti-cancer drugs, such as anti-cancer drugs used as adjuvant chemotherapy for pancreatic cancer to the organoid. Also, perform genomic analysis on each organoid, and then check if there are any unique genomic mutations for each organoid. By recognizing the relationship between the unique genomic mutations and reactivity to the anti-cancer drug within pancreatic cancer patients eligible for surgery, the investigators aim to strategize appropriate adjuvant chemotherapy after surgery, thus developing a platform to predict the outcomes of each patient.
15765041|NCT04736030|Behavioral|Intervention|Twelve weekly sessions will be led by Ms. Schneider and Ms. Montañez supported by Drs. Arredondo and Ayala and student research assistants. Mothers and daughters will participate in weekly virtual 1.5-hour sessions that include didactic teaching, skill building (including PA parenting and communication skills training), interactive discussions, PA, and homework review (homework examples: 30-min walks, practicing communication strategies). Mothers and daughters will attend sessions together, with 10-12 mother-daughter dyads participating in each series. Sessions 2-12 will include at least 30 min PA. Sessions will discuss strategies to engage in PA outside the sessions (goal of 60-min MVPA daily).
15765042|NCT04736017|Device|TSB Axo|The TSB Axo is a wearable biosignal recording device combined with an auditory stimulation. The device consists of pre-gelled biosignal electrodes, headphones integrated in a headband, and a biosignal processing module.
15765043|NCT04735991|Behavioral|Kapok Initiative|"The detailed process is:
~After randomization, the Kapok assistant will contact the patient's family
~The family of the patient joins the Kapok Initiative. They will participate in a 60-minute training program for 27 days, which is taught online by experts; The contents of the lectures are as follows: 1) Doctors are also mortal; 2) New medicines and new therapies; 3) Alternative therapies; 4) Don't panic during the operation; 5) Pain relief; 6) Side effects of treatment; 8) About the truth; 9) New topics; 10) Anti-cancer cost-effectiveness; 11) Medical insurance; 12) Commercial medical insurance; 13) Exercise and rehabilitation; 14) Nutrition and Foods to increase leukocytes level; 15) Long-term persistence; 16) Acceptance Change; 17) Two new roles; 18) Future expectation."
15765044|NCT04735978|Biological|RP3|Genetically modified HSV-1
15765045|NCT04735978|Biological|anti-PD1 monoclonal antibody|anti-PD1 monoclonal antibody
15765046|NCT04735965|Drug|Dexmedetomidine|Dexmedetomidine would be intravenously infused at a dose of 1μg/kg over 15 minutes at the beginning of thoracic closure
15765047|NCT04735965|Drug|Meperidine|Meperidine would be intravenously injected at a dose of 0.5mg/kg at the beginning of thoracic closure
15765048|NCT04735965|Drug|Placeb|Equal volume of normal saline to dexmedetomidine and meperidine group.
15765049|NCT04735939|Radiation|radiotherapy|Determine whether there is a difference in outcomes seen when patients are assigned to take their radiotherapy at either a morning time or evening time.
15765050|NCT04735926|Drug|Calcifediol 75mcg|Soft gelatin capsule. Oral administration once per week
15765051|NCT04735926|Drug|Calcifediol 100mcg|Soft gelatin capsule. Oral administration once per week
15765052|NCT04735926|Drug|Calcifediol 125mcg|Soft gelatin capsule. Oral administration once per week.
15765053|NCT04735926|Other|Placebo|Soft gelatin capsule. Oral administration once per week.
15765054|NCT04735913|Drug|Abiraterone acetate tablets|Subjects will take abiraterone acetate tablets (250 mg, produced by Patheon Ich, trade name: Zytiga®) orally on an empty stomach or after meals and their blood and plasma samples, urine and faeces samples in 72h will be collected for detection.
15765055|NCT04735900|Procedure|Liquid biopsy sampling|Biweekly liquid biopsy sampling to measure circulating tumor DNA (ctDNA) level up to and including 9 months after start first-line therapy.
15765178|NCT04735029|Other|Heat pack|A hydrocollator heat pack used to simulate traditional thermal therapy
15765056|NCT04735887|Other|SADL-eM|The SADL-eM includes three elements essential to the intervention, namely: knowledge, skills, and advice. The manual includes 92 A5 pages with six detailed sections: an Introduction and five chapters: (1) Rehabilitation team, (2) Activities of Daily Living, (3) Assistive devices, (4) Home environment adaptation, and (5) Knowledge guide. The SADL-eM uses text and illustrative pictures that are carefully selected for contextual relevance. The manual is simple, easy, and suitable for people with a non-medical background.
15765057|NCT04735874|Other|Evaluate vascular disease risk factors in children with Down Syndrome|We will determine CV disease risk profiles in children with DS at our centers. We will compare these data to published national norms of children without DS. Risk factor data will include: anthropometric measures; blood pressure; history of congenital heart disease and associated surgery, sleep apnea, hypothyroidism, and cancer; fasting blood draw [lipid panel with subfractions (NMR), insulin, glucose, and CRP].
15765058|NCT04735874|Other|Determine the associations between cardiovascular disease risk factors and markers of early atherosclerosis in children with Down Syndrome|We will perform PWV, CIMT, and CD studies in children with DS and compare these data to available data in children without DS. We will also perform multivariable analysis of the influence of combinations of CV disease risk factors on markers of early atherosclerosis in children with DS. Hypothesis: CV disease risk factors will correlate with markers of early atherosclerosis in children with DS but the associations between risk factors and markers of early atherosclerosis will differ between children with DS vs. the general population of children.
15765059|NCT04735861|Drug|Sintilimab|Sintilimab 200mg iv. q3w, up to 2 years.
15765060|NCT04735861|Drug|Bevacizumab Biosimilar IBI305|Bevacizumab 15mg/kg iv. q3w, up to 22 cycles
15765061|NCT04735848|Dietary Supplement|Iron-supplement application|The participants will take the corresponding amount of iron-supplement supervised at 8am.
15765062|NCT04735835|Other|Dietary Intervention|To carry out a dietary intervention using standardized test meals, where the participant's postprandial response to the meal is measured and is used to predict their postprandial responses to other foods, along with input variables including metabolic profile, anthropometry, sleep and exercise.
15765063|NCT04735822|Drug|Part 1: Belumosudil 40 mg/mL Sequence ABFCED|Oral suspension belumosudil 40 mg/mL in sequence Regimen A, then Regimen B, then Regimen F, then Regimen C, then Regimen E, then Regimen D
15765064|NCT04735822|Drug|Part 1: Belumosudil 40 mg/mL Sequence BCADFE|Oral suspension belumosudil 40 mg/mL in sequence Regimen B, then Regimen C, then Regimen A, then Regimen D, then Regimen F, then Regimen E
15765065|NCT04735822|Drug|Part 1: Belumosudil 40 mg/mL Sequence CDBEAF|Oral suspension belumosudil 40 mg/mL in sequence Regimen C, then Regimen D, then Regimen B, then Regimen E, then Regimen A, then Regimen F
15765066|NCT04735822|Drug|Part 1: Belumosudil 40 mg/mL Sequence DECFBA|Oral suspension of belumosudil 40 mg/mL in sequence Regimen D, then Regimen E, then Regimen C, then Regimen F, then Regimen B, then Regimen A
15765067|NCT04735822|Drug|Part 1: Belumosudil 40 mg/mL Sequence EFDACB|Oral suspension of belumosudil 40 mg/mL in sequence Regimen E, then Regimen F, then Regimen D, then Regimen A, then Regimen C, then Regimen C
15765068|NCT04735822|Drug|Part 1: Belumosudil 40 mg/mL Sequence FAEBDC|Oral suspension of belumosudil 40 mg/mL in sequence Regimen F, then Regimen A, then Regimen E, then Regimen B, then Regimen D, then Regimen C
15765069|NCT04735822|Drug|Part 2: Belumosudil 200 mg Sequence GHI|1 dose of belumosudil 200 mg in sequence Regimen G (tablet), then Regimen H (oral suspension; subject fasted), then Regimen I (oral suspension; subject fed)
15765070|NCT04735822|Drug|Part 2: Belumosudil 200 mg Sequence HIG|1 dose of belumosudil 200 mg in sequence Regimen H (oral suspension; subject fasted), then Regimen I (oral suspension; subject fed), then Regimen G (tablet)
15765071|NCT04735822|Drug|Part 2: Belumosudil 200 mg Sequence IGH|1 dose of belumosudil 200 mg in sequence Regimen I (oral suspension; subject fed), then Regimen G (tablet), then Regimen H (oral suspension, subject fasted)
15765072|NCT04735822|Drug|Part 2: Belumosudil 200 mg Sequence IHG|1 dose of belumosudil 200 mg in sequence Regimen I (oral suspension; subject fed), then Regimen H (oral suspension; subject fasted), then Regimen G (tablet)
15765073|NCT04735822|Drug|Part 2: Belumosudil 200 mg Sequence GIH|1 dose of belumosudil 200 mg in sequence Regimen G (tablet), then Regimen I (oral suspension; subject fed), then Regimen H (oral suspension; subject fasted)
15765074|NCT04735822|Drug|Part 2: Belumosudil 200 mg Sequence HGI|1 dose of belumosudil 200 mg in sequence Regimen H (oral suspension; subject fasted), then Regimen G (tablet), then Regimen I (oral suspension; subject fed)
15765075|NCT04735809|Dietary Supplement|Whole Cell Algae Fermentate|Contains at minimum 50% Beta Glucan
15765076|NCT04735809|Dietary Supplement|Placebo|microcrystalline cellulose
15765078|NCT04735783|Dietary Supplement|Placebo breakfast|Participants will consume a very low-energy, placebo breakfast meal, but will be unaware of its near complete absence of energy until the end of the study.
15765079|NCT04735783|Dietary Supplement|Typical whole-food breakfast|Participants will consume a typical whole-food breakfast meal, equating to 20% of estimated energy requirements.
15765080|NCT04735783|Dietary Supplement|Water-only control|Participants will consume a volume of plain water to match the water content of the very low-energy placebo breakfast and the typical whole-food breakfast.
15765081|NCT04735770|Procedure|Postoperative pain management: LTAP block or local wound anesthesia with levobupivacaine|Postoperative pain management
15765082|NCT04735757|Other|Contrast-enhanced MRI|Contrast-enhanced MRI
15765083|NCT04735757|Other|Measurement of respiratory muscle force|Measurement of the maximum inspiratory and expiratory pressure.
15765105|NCT04735549|Other|The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire|The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency).
15765106|NCT04735549|Other|Vulvovaginal Symptoms Questionnaire|Vulvovaginal Symptoms Questionnaire will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency).
15765084|NCT04735744|Other|Patients recovering from COVID19 receive usual care by allied health professionals|We will not develop specific interventions for this prospective observational cohort study. The care provided by allied health professionals in daily practice are based on recommendations published by the professional bodies of allied health professionals and on the interdisciplinary guidance developed by the LAN. All allied health professionals are working according to these recommendations. Dissemination of these recommendations is done by the professional bodies of the allied health professionals. Given the observational nature of our study, no additional implementation strategies will be employed to stimulate this care by the research group.
15765085|NCT04735731|Diagnostic Test|Echography|Echography of diaphragma and other respiratory muscles
15765087|NCT04735705|Device|Cerviron|Cerviron ovules ® is a class IIb medical device indicated as adjuvant in the treatment of acute and chronic vulvovaginitis of mechanical etiology, caused by changes of vaginal pH and changes of the vaginal flora. It is also used in cervical lesions of mechanical origin as it favors the healing and re-epithelialization processes and reduces the proliferation of endogenous pathogens.
15765088|NCT04735692|Other|Observation of serum and salivary MMP-9 levels|Evaluation of serum and salivary MMP-9 levels
15765089|NCT04735666|Device|TauroPace™|TauroPace™ is intended to be used as a disinfecting solution during any CIED related surgery procedure or handling of any uncoated or silicon-, epoxy- or polyurethane-coated CIED (including its components, e.g., leads) made of titan or stainless steel in any adult patient requiring or carrying a CIED.
15765090|NCT04735653|Behavioral|Personalized Glaucoma Coaching|This is a six-month personalized glaucoma coaching program where a coach trained in motivational interviewing (MI)-based counseling uses a web based tool that generates tailored education to help glaucoma patients identify their barriers to optimal medication adherence and explore potential solutions during three in-person coaching sessions. The coach provides between-session support through four phone calls, with two phone calls between the first and second session and one phone call after each subsequent session. Participants can elect to receive any of the following type of alarm when a dose of medication is due: visual or audible alert or automated text or phone call reminder. Glaucoma medication adherence will be monitored electronically for all participants between the baseline visit and the exit visit six months later.
15765091|NCT04735653|Behavioral|Enhanced Standard care|Participants will receive non-tailored educational materials about glaucoma from leading sources by mail every 2 months for a total of 3 mailings during the 6-month study period. Glaucoma medication adherence will be monitored electronically for all participants between the baseline visit and the exit visit six months later.
15765092|NCT04735640|Behavioral|nurse-led teleconsultation|Patients assigned to this group will receive personalized dietary and physical activity advice during 9 months. Behavioural goals and action plans will be developed in a stepwise manner in accordance with baseline levels of nutritional and physical activity adherence to recommendations.
15765093|NCT04735640|Behavioral|SMS|Patients assigned to this group will receive a total of 150 text messages (4 to 5 messages per week during weekdays) throughout the intervention period (9 months). The content of the text messages includes advice on diet and exercise.
15765094|NCT04735627|Device|Levodopameter|The device is a microneedle sensor that can detect levodopa levels in the interstitial fluid.
15765095|NCT04735614|Device|Posthorax Thoraxbelt|The patients will be assisted to put on the ThoraxBelt after the surgery by our research member and will be asked to keep it on except for during showering through the whole study period.
15765096|NCT04735601|Procedure|Ahmed Valve|Ahmed valve implantation coated with poly lactic -co-glycolic acid (PLGA) saturated with Mitomycin-C in the management of adult onset glaucoma in Sturge Weber syndrome
15765097|NCT04735575|Biological|EMB-06|EMB-06 is a FIT-Ig® bispecific antibody against BCMA and CD3.
15765098|NCT04735549|Device|Laser Treatment|"Laser radiation is emitted by a series of pulses following each other through a pause. The duration of one pulse is 20-200 ns, the pause between pulses is 30 us. The energy of one pulse is about 1 mJ.
~General laser radiation parameters for 1st and 2nd stages are: beam with diameter of 4 millimeters (mm) scans treatment area by 4 circles with step of 2 mm (50 percentage (%) overlap), average power of 10-25 Watt (W), treatment time in one point of 1-10 seconds (s), treatment step of 5 mm, from 1 to 5 repetitions of total vagina treatment. General laser radiation parameters for 3d stage are: beam diameter of 6 mm, average power of 15-30 W, duration of ns-pulses packet of 50-100 milliseconds (ms), pause between packets of 50-100 ms, treatment duration up to 65 s, treatment in permanent motion with speed of 10-50 mm/s.
~The procedure is performed without anesthesia. The doctor always focuses on the participant's feeling of warmth."
15765099|NCT04735549|Drug|Topical hormone estriol|Estriol ((17 beta)-estra-1,3,5 (10)-trien-3,17-diol). Daily dose will be 0.5 gram daily for 2 weeks, later 0.5 gram twice a week for 12 months.
15765100|NCT04735549|Diagnostic Test|Сlinical blood analysis|Taking blood from a vein for Clinical blood analysis, Wassermann reaction (WR), human immunodeficiency viruses (HIV), hepatitis B infection (HBsAg), hepatitis C infection (HCVAg) determination, glucose test (to include the participant in the study).
15765101|NCT04735549|Diagnostic Test|Сlinical urine test|Urine sampling for Clinical urine test (to include the participant in the study).
15765102|NCT04735549|Diagnostic Test|Vaginal smear|Vaginal smear for flora investigation (to include the participant in the study), cytology, microbiological analysis with Gram staining (to evaluate procedure efficiency).
15765103|NCT04735549|Diagnostic Test|Pelvic ultrasound|Pelvic ultrasound investigation to determine pathologies of the pelvic through a gynecological probe (to include the participant in the study).
15765104|NCT04735549|Other|Female Sexual Function Index|Female Sexual Function Index will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency).
15765179|NCT04735016|Device|DiamondTemp™ Ablation System|A cardiac ablation will be performed using the DiamondTemp™ Ablation System.
15765107|NCT04735549|Diagnostic Test|Vaginal Health Index|Vaginal Health Index will be investigated by clinical examination for vaginal elasticity, vaginal secretions, epithelial mucous membrane, vaginal hydration. Potential of hydrogen (pH) will be investigated by test-lines paper (to evaluate procedure efficiency).
15765108|NCT04735549|Diagnostic Test|Elastography (ultrasound investigation)|Ultrasound investigation for assessing elasticity / stiffness of tissues of vulva region with Mindray device (head L14-6WU) (to evaluate procedure efficiency).
15765109|NCT04735549|Diagnostic Test|Perineometry|Pressure force of vaginal walls measurement with EmbaGYN device (to evaluate procedure efficiency).
15765110|NCT04735549|Other|Visual Analogue Scale (VAS)|Visual Analogue Scale will be used to collect feedback on changes in the participants life quality (to evaluate procedure efficiency).
15765111|NCT04735536|Drug|CT1812|Active Treatment- CT1812 at a dose of 300mg
15765112|NCT04735536|Other|Placebo|Placebo Comparator
15765113|NCT04735523|Drug|Dabigatran|Dabigatran dispensing claim is used as the exposure group
15765114|NCT04735523|Drug|Warfarin|Warfarin dispensing claim is used as the reference group
15765115|NCT04735510|Drug|cyclosporine ophthalmic emulsion 0.05%|All subjects will receive restasis
15765116|NCT04735484|Device|Gait analysis|Collecting movement data whilst participants walk
15765117|NCT04735471|Genetic|ADI-001|Anti-CD20 CAR-T
15765118|NCT04735471|Drug|Fludarabine|Chemotherapy for Lymphodepletion
15765119|NCT04735471|Drug|Cyclophosphamide|Chemotherapy for Lymphodepletion
15765120|NCT04735471|Drug|Bendamustine|Chemotherapy for Lymphodepletion
15765121|NCT04735471|Drug|Interleukin-2|To support growth and activation of ADI-001
15765122|NCT04735458|Other|Procedure/Surgery: Response Inhibition and Deep Brain Stimulation in Parkinson's disease|After creation of the burr hole and prior to DBS electrode placement, 1-2 subdural strip electrodes will be placed anteriorly or posteriorly from the cranial opening. These electrodes are routinely placed using this technique for seizure mapping, with arrays of electrodes (up to 6) being placed around the perimeter of the opening.14 Subdural strips vary in length and contact size (e.g., the 6-contact Ad-Tech strip), and are currently placed predominantly for studies of sensorimotor function,13 including at our institution (IRB-140327003). Placement over prefrontal areas is performed at other institutions.11-13 The DBS surgery will then proceed according to routine practice, and following lead placement in the optimal desired location, the research task paradigm will begin.
15765123|NCT04735445|Diagnostic Test|Digital rectal exam and / or anal cytology (day 1 and after 36 months)|For anal screening in MSM man or woman with abnormal cervical cytology, genital warts or having anal sex (day 1 and after 36 months)
15765124|NCT04735445|Diagnostic Test|Semestral digital rectal exam and / or anal cytology if abnormal → ANOSCOPY with biopsy|For anal screening in MSM man or woman with abnormal cervical cytology, genital warts or having anal sex (semestral)
15765125|NCT04735445|Diagnostic Test|Cervical cytology and cervical sample for HPV detection (day 1 and after 36 months)|For Cervix Screening in sexually active woman (day 1 and after 36 months)
15765126|NCT04735445|Diagnostic Test|Semestral cervical cytology and cervical sample for HPV detection|For Cervix Screening in sexually active woman (semestral)
15765127|NCT04735445|Diagnostic Test|Appointment for mammography (day 1 and after 36 months)|For Breast Screening in woman between 50-70 years old (day 1 and after 36 months)
15765128|NCT04735445|Diagnostic Test|Annual appointment for mammography|For Breast Screening in woman between 45-70 years old (annual)
15765129|NCT04735445|Diagnostic Test|Semestral appointment for liver ultrasound|"For Hepatic Screening:
~Cirrhosis or Chronic HBV, and meet any of the following risk factors:
~Asian male> 40 years old
~Asian woman> 50 years old
~African man or woman
~HCC family history"
15765130|NCT04735445|Diagnostic Test|Semestral appointment for liver ultrasound|Having chronic liver disease with fibrosis ≥ F3 or Presents chronic HBV
15765131|NCT04735445|Diagnostic Test|Semestral blood collection for alpha-fetoprotein and others hepatic biomarkers determination|Having chronic liver disease with fibrosis ≥ F3 or Presents chronic HBV
15765132|NCT04735445|Diagnostic Test|Fecal occult blood test (day 1 and after 36 months)|"For Colon Screening:
~Age between 50-70 years old"
15765133|NCT04735445|Diagnostic Test|Annual fecal occult blood test|"For Colon Screening:
~Age older than 40 years"
15765134|NCT04735445|Diagnostic Test|Digital rectal exam and PSA determination (day 1 and after 36 months)|"For Prostate Screening:
~Man older than 50 years"
15765135|NCT04735445|Diagnostic Test|Annual digital rectal exam and PSA determination|"For Prostate Screening:
~Man older than 50 years"
15765136|NCT04735445|Diagnostic Test|Annual appointment for low dose computed tomography for lung screening|"For Lung Screening: should accomplish
~ALL the following criteria:
~Age > 40 years
~Active smoker or former smoker<3 years, with IPY ≥20. IPY: index of packages-year: nº packages that smoke per day x nº years smoking
~No contraindications for thoracic surgery
~No lung infection in the last 2 months"
15765137|NCT04735445|Diagnostic Test|Annual general inspection for skin lesions suggestive of malignancy|"For Skin Screening:
~Woman ≥18 years Man ≥40 years"
15765138|NCT04735432|Biological|efgartigimod PH20 SC|Subcutaneous injection with efgartigimod PH20 SC
15765139|NCT04735432|Biological|efgartigimod IV|Intravenous infusion of efgartigimod
15765140|NCT04735419|Other|No intervention|No intervention
15765141|NCT04735393|Drug|Reproxalap Ophthalmic Solution (0.25%)|Reproxalap Ophthalmic Solution (0.25%) administered for six weeks (QID for four weeks then BID for two weeks).
15765142|NCT04735393|Drug|Placebo Comparator|Vehicle Ophthalmic Solution administered for six weeks (QID for four weeks then BID for two weeks).
15765143|NCT04735393|Drug|Reproxalap Ophthalmic Solution (0.25%)|Reproxalap Ophthalmic Solution (0.25%) administered for one year (QID for four weeks then BID for 11 months).
15765144|NCT04735393|Drug|Placebo Comparator|Vehicle Ophthalmic Solution administered for one year (QID for four weeks then BID for 11 months).
15765145|NCT04735380|Device|TCM-5 Flex monitor connected to a Sensor 84 (Radiometer Medical Aps, Brønshøj, Denmark)|Patients undergo 2-3 hrs of observation while wearing the device.
15765146|NCT04735367|Drug|palbociclib plus letrozole|palbociclib plus letrozole
15765148|NCT04735341|Device|Ion Endoluminal System|Ion Endoluminal Procedure for pulmonary nodule
15765150|NCT04735328|Behavioral|CT-PTSD|CT-PTSD (Cognitive Therapy for PTSD), treatment method developed for treating patients with Post Traumatic Stress Symptoms (PTSD).
15765151|NCT04735328|Behavioral|EMDR|EMDR (Eye Movement and Desensitization Reprocessing), treatment method developed for treating patients with Post-Traumatic Stress Symptoms (PTSD).
15765152|NCT04735315|Other|Preterm birth|The study compares young adult subjects born premature (< 29 weeks) versus term > 37-41 weeks)
15765153|NCT04735302|Other|Radiographic Feature|Radiographic rewiev
15765154|NCT04735289|Other|EPIC-COS Food Frequency Questionnaire diet Evaluation|Anthropometric measurements (Body mass Index, Lean and fat body composition evaluation) and diet habits evaluation with EPIC-COS-FFQ
15765155|NCT04735289|Other|Metabolome, Microbiota, Lymphocytes subpopulations|"At diagnosis before any treatment for bone sarcoma will be obtained :
~a blood sample for metabolomics analyses
~a stool sample for microbiota analysis
~Lymphocyte subpopulations (CD3, CD4, CD8, NK) will be analyzed in blood samples"
15765156|NCT04735276|Device|HFNO for 5 min|1st basic MRI then HFNO for 5 min with mouth closed breathing and 2nd MRI. Analysis of the surface of the gastric antrum.
15765157|NCT04735263|Drug|Atorvastatin 80mg|Patient will be receiving 80mg of Atorvastatin, if they are able to tolerate it from the start to the end of the study.
15765158|NCT04735237|Procedure|Autogenous fat injection|Done under general anesthesia. Fat is to be harvested from the abdomen using manual liposuction. Small aliquots of fat are to be injected into the philtral column (and in the vermilion and any other area of volume insufficiency if needed).
15765159|NCT04735237|Procedure|Surgical revision with orbicularis oris muscle reconstruction.|Surgical repair done under general anesthesia. The original scar will be marked on the skin with methylene blue. The skin will be incised along the designed line with scar removal. The orbicularis oris muscle stump will be dissected medially and laterally and approximated by means of 4-0 inverted horizontal mattress sutures.
15765160|NCT04735211|Procedure|Surgery|Pediatric Surgery with hospitalized
15765161|NCT04735198|Procedure|Primary tumor surgery|Large bowel resection.
15765162|NCT04735198|Procedure|Primary tumor surgery (bowel resection) combined with prophylactic cholecystectomy|Large bowel resection combined and cholecystectomy.
15765163|NCT04735185|Other|Autologous stem cells|In this intervention participants will receive a 2 mL intradiscal injection into each affected disc of autologous bone marrow-derived mesenchymal stem cells from bone marrow aspirate of the posterior ilium.
15765164|NCT04735185|Drug|Corticosteroid|In this intervention participants will receive a 1 mL intradiscal injection of the steroid methylprednisolone (40 mg/mL) into each affected disc.
15765165|NCT04735185|Drug|Local anesthetic|In this intervention participants will receive a 1 mL intradiscal injection of the local anesthetic bupivacaine 0.5% into each affected disc.
15765166|NCT04735172|Other|specific MRI Acquisition (NMR spectroscopy) at 7T|"The MRI protocol will be performed at 7T on a Siemens NMR imaging system (Magnetom Terra, Siemens Healthcare, Erlangen, Germany), the radio frequency emission and signal reception will be done through a head quadrature resonator (64-channel phase-array coil). To avoid motion-related artifacts, the patient will be seated in a supine position, with the arms along the body and the head immobilized using a suitable head restraint. The MR protocol will take place in two phases:
~Acquisition of 3D multi-slice T1 and T2-weighted morphological images to identify areas of interest;
~Acquisition of 1D RMN spectra in the right and left putamen and STN. Spectra will be acquired in volumes of interest of 15mmx15mmx15mm using a localized spectroscopy sequence with and without suppression of the water signal. Main parameters are: TR (repetition time)=3000ms; TE (echo time)=20 ms; number of repetitions=128; scan time 6min)."
15765167|NCT04735159|Device|SCS implanted with Precision SpectraTM|Analyze the relationship between neuroimaging biomarkers and the different clinical scales and variables captured from each patient
15765168|NCT04735146|Other|Adapted physical activity|"Participants in the experimental group will undergo the adapted physical activity program that will be co-designed during phase I of the study.
~The 6-week program is aimed at improving the quality of life; increase the physical activity levels according to recommended guidelines; improving body awareness through an educational component; maintain and ameliorate the previous functions (for women previously active) and build the exercise background for sedentary women; increase physical fitness and functional capacity."
15765169|NCT04735133|Device|pNBYT|pNPWT device (80mm Hg) was placed in the pNPWT group for seven days The incision area was evaluated during the first seven days, and on the 15th, 21st, and 30th days postoperatively for the presence of hematoma, seroma, wound dehiscence/evisceration, and SSI.
15765170|NCT04735120|Device|iLASE DIODE LASERS|940nm diode laser with 1.5 watts activated in a continuous mode and applied on to the canal orifices during root canal treatment to reduce intraoperative pain and further its effect on post operative pain is assessed
15765171|NCT04735107|Procedure|colorectal anastomosis reinforcement and trans-anal drainage|Circular mucosal flap created to cover stapled anastomosis + vacuum sponge drainage
15765172|NCT04735094|Diagnostic Test|Endobronchial biopsy with the use of a balloon attached to the echo-bronchoscope|A small balloon made of latex can be attached to the tip of echo-bronchoscope which is then inflated with water or saline for better apposition of the echo-endoscope and the airway wall. This may improve ultrasound image quality and aid better visualization of the lymph nodes.
15765173|NCT04735068|Drug|Binimetinib Pill|Patients will be treated with B 45 mg two times daily and HCQ 400 mg twice daily beginning on day 1. The dose of HCQ is based on an ongoing Phase 1 trial, and may be modified in a future amendment prior to the first patient enrolled. Efforts will be made to ensure dose homogeneity throughout the trial. Treatment will be administered on an outpatient basis on a 28 day cycle
15765174|NCT04735068|Drug|Hydroxychloroquine Pill|Patients will be treated with B 45 mg two times daily and HCQ 400 mg twice daily beginning on day 1. The dose of HCQ is based on an ongoing Phase 1 trial, and may be modified in a future amendment prior to the first patient enrolled. Efforts will be made to ensure dose homogeneity throughout the trial. Treatment will be administered on an outpatient basis on a 28 day cycle
15765175|NCT04735042|Drug|Empagliflozin / Linagliptin or Dapagliflozin/Saxagliptin Pill|association between SGLT2-inhibitor and DPP4-inhibitor
15765176|NCT04735042|Drug|Empagliflozin or Dapagliflozin Pill|SGLT2-inhibitor: diabetic oral drug with diuretic properties.
15765177|NCT04735029|Device|Thermal gun|"Thermal gun used a heat-generating ceramic head to apply a dual effect called heat-and-light-pressure on the acupuncture points."
15765180|NCT04735003|Device|Transcatheter tricuspid valve interventions|Transcatheter repair or replacement to treat tricuspid regurgitation
15765181|NCT04734990|Drug|Azacitidine|Given IV or SC
15765182|NCT04734990|Drug|Seclidemstat|Given PO
15765183|NCT04734977|Device|High-intensity laser therapy (HILT)|High intensity laser therapy-Patients received pulsed laser treatment, using a HIRO 3 device (ASA Laser, Arcugnano, Italy), five times a week for a period of four weeks, and one session per day for a total of 20 sessions. A 3-phase treatment program was performed in each session.
15765184|NCT04734977|Device|Sham high-intensity laser therapy (Sham HILT)|Sham High intensity laser therapy was applied in five sessions a week for four weeks, with a total of 20 sessions a day, with no current flowing through the device using a HIRO 3 device (ASA Laser, Arcugnano, Italy).
15765185|NCT04734977|Other|Therapeutic Exercise|"As therapeutic exercise program; active cervical ROM, cervical isometric and progressive (self-exercise with Thera-Band) strengthening muscles; trapezius, scalene, rhomboid, levator scapular, pectoral, suboccipital muscles stretching exercises, scapular stabilization exercises.It was planned to implement a total of 20 sessions 5 days a week for 4 weeks, for approximately 30 minutes.
~Exercises will be performed by a trained (at least 5 years experienced) physiotherapist, three times a day, in 3 sets, 10 repetitions."
15765186|NCT04734964|Behavioral|exercise training|Exercise training session for 45 minutes.
15765187|NCT04734951|Other|Power/resistance exercise program|participants will complete a power/resistance program during 14 weeks. The exercise program will consist of training to improve muscle strength, neuromotor skills, flexibility, endurance, and a greater emphasis on maximum strength and power. The intensity will be set according the estimated repetition to failure.
15765188|NCT04734951|Dietary Supplement|HMB supplementation|Daily oral supplementation with 237 ml of a polymeric nutritional formula added with 1.5 g of HMB (Ensure Advance®)
15765189|NCT04734938|Dietary Supplement|Huel Powder|Huel is made of an ultra-fine blend of sustainable ingredients. Oats, rice, peas, coconut, flaxseed, and our unique mix of vitamins and nutrients to provide you a meal with all the carbohydrates, protein, essential fats, fibre, and all the 26 essential vitamins and minerals your body needs to thrive. Volunteers will consume only Huel as their food source for the final four weeks of the study.
15765190|NCT04734912|Other|gastroscopy in transnasal techique|All patients with indication for gastroscopy in transnasal technique are included.
15765191|NCT04734899|Other|Exercise program|Strengthening with resistance bands for tibialis posterior, tibialis anterior, peroneus longus, finger flexors, hip and knee muscles, sheet gathering exercises, fingertip walking exercises, Stretching exercises for gastrocnemius and soleus muscles, plantar fascia stretching, weight transfer on one leg
15765192|NCT04734899|Other|Foot core training|Short foot exercises with passive modeling, active assisted modeling, active modeling, functional training
15765193|NCT04734886|Dietary Supplement|L. reuteri DSM 17938 + vitamin D|1 * 10^8 CFU of L. reuteri DSM 17938 + 10 ug vitamin D3, two capsules per day for 6 months
15765194|NCT04734886|Dietary Supplement|Placebo + vitamin D|Placebo tablet + 10 ug vitamin D3, Similar in shape and taste to intervention capsules but without the probiotic components, two capsules per day over six weeks
15765195|NCT04734873|Drug|CPI-006 2 mg/kg + SOC|IV CPI-006 2 mg/kg up to a maximum dose of 200 mg plus standard of care
15765196|NCT04734873|Drug|CPI-006 1 mg/kg + SOC|IV CPI-006 1 mg/kg up to a maximum dose of 100 mg plus standard of care
15765197|NCT04734873|Drug|Placebo + SOC|IV placebo plus standard of care
15765198|NCT04734860|Biological|COVI-AMG|COVI-AMG is a fully human SARS-CoV-2 neutralizing monoclonal antibody (mAb)
15765199|NCT04734860|Drug|Placebo|Diluent solution
15765200|NCT04734847|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|Non-invasive magnetic stimulation of the brain
15765201|NCT04734847|Device|Sham Repetitive Transcranial Magnetic Stimulation (Sham-rTMS)|Device that appears identical to the active rTMS device, but does not produce any magnetic field and does not stimulate the brain.
15765202|NCT04734834|Dietary Supplement|"Prodovite® VMP35"|"Efficacy of Prodovite® VMP35 will be Assessed as Compared to Placebo"
15765203|NCT04734821|Procedure|Near Infra-Red Fluorescence Guided Surgery|ICG injection around tumor each four direction by endoscopy followed by NIR fluorescence guidance laparoscopic or robotic esophagectomy or gastrectomy
15765204|NCT04734808|Diagnostic Test|Electroencephalography|Electroencephalography is an electrophysiological monitoring method to record electrical activity of the brain.
15765205|NCT04734808|Diagnostic Test|Electromyography|Electromyography is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles. We will use the hdEMG version.
15765206|NCT04734782|Diagnostic Test|Determination of antibodies in maternal serum IgG for respiratory syncytial virus|By venipuncture, a blood sample will be taken and the levels of anti-RSV IgG antibodies will be processed in serum by commercial techniques.
15765207|NCT04734769|Other|Collect retrospectively clinical data on reproductive outcomes|Collect retrospectively clinical data on reproductive outcomes
15765208|NCT04734756|Device|Dragonfly Transcatheter Mitral Valve Repair System|To conduct edge-to-edge repair with Dragonfly System under the guidance of transesophageal echocardiography.
15765209|NCT04734743|Other|cystic fibrosis|Evaluation of Upper Extremity Muscle Strength and Endurance, functional capacity, Respiratory Function and Quality of Life
15765210|NCT04734730|Drug|Abiraterone Acetate|Given PO
15765211|NCT04734730|Drug|Bicalutamide|Given PO
15765212|NCT04734730|Drug|Degarelix|Given SC
15765213|NCT04734730|Drug|Goserelin Acetate|Given SC
15765214|NCT04734730|Drug|Leuprolide Acetate|Given IM
15765215|NCT04734730|Drug|Prednisone|Given PO
15765216|NCT04734730|Other|Questionnaire Administration|Ancillary studies
15765217|NCT04734730|Drug|Talazoparib|Given PO
15765218|NCT04734717|Diagnostic Test|Neurology test|movement examination of patients with covid19 disease
15765219|NCT04734704|Procedure|skin swabs at lesional and non-lesional sites|It will be examined in patients skin swabs sampled at lesional and non-lesional sites
15765220|NCT04734704|Procedure|skin swabs on skin|It will be examined in patients skin swabs sampled on skin
15765221|NCT04734691|Procedure|PIPAC|PIPAC is a laparoscopic procedure for intraperitoneal administration of chemotherapy
15765222|NCT04734678|Drug|Tocilizumab|400 mg IV only once
15765224|NCT04734665|Drug|Niraparib-Bevacizumab|"Niraparib 200mg or 300mg (once daily[QD]) Bevacizumab 15mg/kg every 3 weeks (Q3W)
~*The recommended starting dosage of niraparib is 200mg QD. For patients who weigh ≥77 kg and have baseline platelet count ≥150,000/μL, the recommended starting dosage is 300 mg QD."
15765225|NCT04734652|Combination Product|Biktarvy®|"Biktarvy® is a fixed dose combination, single tablet containing bictegravir (BIC), emtricitabine (FTC), and tenofovir alafenamide (TAF) for oral administration.
~BIC is an integrase strand transfer inhibitor (INSTI). FTC, a synthetic nucleoside analog of cytidine, is an HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI). TAF, an HIV NRTI, is converted in vivo to tenofovir, an acyclic nucleoside phosphonate (nucleotide) analog of adenosine 5'-monophosphate. Each tablet contains 50 mg of BIC (equivalent to 52.5 mg of bictegravir sodium), 200 mg of FTC, and 25 mg of TAF (equivalent to 28 mg of tenofovir alafenamide fumarate) and the following inactive ingredients: croscarmellose sodium, magnesium stearate, and microcrystalline cellulose."
15765226|NCT04734652|Combination Product|TLD- fixed-drug combination single tablet|Standard of care Dolutegravir-based regimen
15765227|NCT04734639|Behavioral|CON . control condition without exercise / rest condition|Control condition without exercise / rest condition. The adolescents will be asked to remain quiet and at rest during the morning and will receive an ad libitum meal at dinner time. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals.
15765228|NCT04734639|Behavioral|Def-Mixed. Condition with a mixed energy deficit induced by exercise + dietary restriction.|Def-Mixed. Condition with an exercise-induced energy deficit The adolescents will received a calibrated lundh meal with a deduction of 250 kcal compared with the lunch meal of Con; and will be asked to realise an acute exercise set at 65% of their capacities (cycling) during the afternoon, inducing an energy expenditure of 250 kcal. Dinner will be served ad libitum. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals.
15765229|NCT04734639|Behavioral|Def-EI. Condition with an energy-restriction energy deficit|Condition with an energy-restriction energy deficit The adolescents will receive a calibrated breakfast reduced from 500 kcal compare to their CON and Def-mixed conditions. Dinner will be served ad libitum. Their food reward will be assessed before dinner. Their appetite feelings will be assessed at regular intervals.
15765230|NCT04734626|Diagnostic Test|Creatine Chemical Exchange Saturation Transfer (CrCEST) Imaging Sequence|CrCEST be used to assess creatine distribution and concentrations in muscle (lower extremity), both at rest and after recovery from a brief foot-pedal depression exercise
15765231|NCT04734613|Behavioral|Tai Chi exercise|Yang style Tai Chi 16 movements
15765232|NCT04734613|Behavioral|self management|health education and dietary counseling
15765233|NCT04734600|Device|Electronic Treadmill device|"group A:PN-7001M Panasonic Treadmill 130 kg, frequency 50 HZ, input voltage AC220 V, input power 100W+_ 10 will usefor aerobic training program ,start by 1pbm grading to 2pbm speed and increase according to patient abilities during sessions ,0% treadmill inclination angle for two month as a total treatment period for study group patients.
~Patients in this group will participate in aerobic training as march walking on treadmill for 45 mints duration for session 3 times per week, start with 5 mints warm up beginning and 5 mints cooling down at end session, in addition to their medical program and burger exercises"
15765234|NCT04734600|Other|myofascial release technique|"group B:The myofascial release technique group will receive a 45 mints session time, for3 times per week for two months in addition to their medical program and burger exercises. Before the MF will starte, patient will rested in a relaxed prone position for 15 to 30 mints and also after end session time, MF protocol will applied as follow sequence over all period of total treatment sessions (8) week.:
~thoracolumbar cross hand facial release technique for at least 5 mints for every barrier depth area, started by one hand will place on high thoracic area with pressure applied cephalic, the other hand was placed directly on the lower lumbo -sacrum area pushing caudal and arms are crossed to maximize as leverage as the barrier sense of softening will occurre and release sense on fascia under hand (release done at transverse alternative with longitudinal direction)alternation same methods to affected leg"
15765235|NCT04734587|Diagnostic Test|Blood serum Neuron-specific Enolase measurement|The Silent Brain Injury ratio was compared by measuring the Neuron-specific enzyme level with venous blood sampling from both patient groups before and after percutaneous coronary intervention.
15765236|NCT04734561|Other|Inspiratory muscle training group|Participants will perform an inspiratory muscle training including warm-up, recovery between intervals and return to calm.
15765237|NCT04734561|Other|Inspiratory muscle training placebo group|Participants will perform an inspiratory muscle training including warm-up, recovery between intervals and return to calm.
15765238|NCT04734561|Other|Inspiratory + expiratory muscle training group|Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.
15765239|NCT04734561|Other|Inspiratory + expiratory muscle training placebo group|Participants will perform an inspiratory and expiratory muscle training including warm-up, recovery between intervals and return to calm.
15765240|NCT04734548|Drug|ApTOLL|ApTOLL is a Toll-like receptor 4 (TLR4) antagonist, a receptor that is involved in innate immune responses but also responds to tissue damage, and therefore it is directly involved in a large number of diseases where the inflammatory response is involved. ApTOLL has demonstrated specific binding to human TLR4 as well as a TLR4 antagonistic effect, reducing inflammation and improving outcome after different disease models.
15765241|NCT04734548|Other|Placebo|White freeze-dried powder which is indistinguishable to ApTOLL for taste, color, texture and size.
15765242|NCT04734535|Device|HEMOBLAST™ Bellows|Intraoperative bleeding during epidural spine surgery will be treated with HEMOBLAST™ Bellows
15765243|NCT04734535|Device|absorbable gelatin sponge with thrombin|Intraoperative bleeding during epidural spine surgery will be treated with absorbable gelatin sponge with thrombin
15765244|NCT04734522|Device|Progressive Additional Lenses (PAL), pre calibrated and made of polymeric material with anti-reflection coating|Subjects will be wearing three different PAL designs with different geometries of the optical progression.
15765245|NCT04734509|Device|Silhouette breathing system|The Silhouette is a single-use nasal mask and breathing circuit with lightweight tubing and an adhesive strip across the bridge of the nose to secure the mask in place and create a good seal around the patient's nose.
15765289|NCT04734197|Drug|Xiidra 5% Ophthalmic Solution|topical ophthalmic solution
15765290|NCT04734197|Drug|Mycophenolic Acid 0.3%|topical immunosuppressant
15765246|NCT04734496|Other|National Healthcare System Standard of care for each disease type (National Institute for Health and Care Excellence guidelines)|National Healthcare System Standard of care for each disease type (National Institute for Health and Care Excellence guidelines)
15765247|NCT04734483|Diagnostic Test|spirometry|spirometry
15765248|NCT04734483|Radiation|MRI and CT|MRI and CT
15765249|NCT04734483|Other|Laryngoscopy|laryngoscopy
15765250|NCT04734483|Other|electromyography|electromyography
15765251|NCT04734470|Diagnostic Test|Flow cytometry|The study of CD19 complex expression in lymphoproliferative disorders by flowcytometry
15765252|NCT04734457|Drug|Levothyroxin|We assess the effect of early diagnosis of CH by neonatal screening and start of treatment on the final height of the patients
15765253|NCT04734444|Device|SonoClear ACF|The SonoClear ACF is intended to be used as an acoustic coupling fluid during ultrasound imaging in brain surgery of human beings
15765254|NCT04734431|Biological|Eosinophil count|Evaluation of the eosinophil count from admission to day 7
15765255|NCT04734418|Drug|Remifentanil|Intravenous pump injection.The initial dose of remifentanil is 0.05 μg/kg/min.The drug dosage will be adjusted according to the subjects' intolerance relief (the treatment target is NIS ≤ 2), and the maximum dosage of remifentanil is 0.12 μg/kg/min
15765256|NCT04734418|Drug|Dexmedetomidine|Intravenous pump injection.The initial dose of dexmedetomidine is 0.5 μg/kg/h.The drug dosage will be adjusted according to the subjects' intolerance relief (the treatment target is NIS ≤ 2), and the maximum dosage of dexmedetomidine is 1.0 μg/kg/h.
15765257|NCT04734405|Drug|Prof-001|Prof-001 cream
15765258|NCT04734405|Drug|Fluconazole 150 mg|Fluconazole capsule
15765259|NCT04734405|Drug|Placebo cream|ointment base to mimic Prof-001
15765260|NCT04734405|Drug|Placebo capsule|encapsulated lactose powder to mimic 150 mg fluconazole capsule
15765261|NCT04734392|Procedure|TAVR|TAVR implantation in cusp overlay technique
15765262|NCT04734379|Drug|Fasudil|Oral fasudil 180 mg/day
15765263|NCT04734366|Procedure|"Uterine closure with Baseball suture technique"|"A simple running (continuous) baseball suture is essentially an interrupted sutures. Applied as inside to outside/inside to outside of incision."
15765264|NCT04734366|Procedure|Single Layer Continuous Locked|Suturing is continued by passing through the previous stitch.
15765265|NCT04734353|Drug|Prasugrel 5mg|Prasugrel 20 mg loading, followed by prasugrel 5 mg/day for 12 months
15765266|NCT04734353|Drug|Ticagrelor 60mg|Ticagrelor 120 mg loading, followed by ticagrelor 60 mg bid for 12 months
15765267|NCT04734340|Procedure|EIT-guided PEEP setting|Ventilator parameter setting by EIT
15765268|NCT04734340|Procedure|ARDS-net PEEP setting|Ventilator parameter setting according to ARDS-net table
15765269|NCT04734327|Procedure|Orthokine periradicular injection|Ultrasound guided injections
15765270|NCT04734327|Procedure|Orthokine epidural injection|Ultrasound guided injections
15765271|NCT04734314|Other|conventional physical therapy|conventional physical therapy in the form of transcutaneous electrical stimulation (TENS) for 20 min and hot pack for 10 min Each patient received 12 sessions three session per week.
15765272|NCT04734314|Other|vojta therapy|"Vojta Dynamic Neuromuscular Stabilization (DNS) is a therapy used to manage neurological and musculoskeletal conditions each patient in the study group (group B) was instructed to lie prone on an examination table with the participant's shoulders abducted, elbows flexed approximately 80-90°, and the forearms hanging off the edge of the table. Pressure-like stimulation of the calcaneus and ASIS were performed in the postural position named by Vojta as reflex creeping.
~Each patient received 12 sessions three session per week."
15765273|NCT04734301|Device|Intravaginal Electrical Stimulation (2 times/week)|IVES sessions were performed two times in a week, for 10 weeks. Every session lasted 20 minutes. The intervention comprised a 20-sessions treatment program of ES. The stimulation parameters were frequency at 10 Hz, a 5-10s work-rest cycle and 100 ms pulse width. The symmetric biphasic pulse wave could be delivered over a range of 0-100 mA. The intensity was controlled according to patients' discomfort level feedback.
15765274|NCT04734301|Device|Intravaginal Electrical Stimulation (5 times/week)|IVES performed in the same way as Group 1, except for frequency of treatment. IVES sessions were performed five times in a week, for 4 weeks. Every session lasted 20 minutes. The intervention comprised a 20-sessions treatment program of ES. Stimulation parameters were the same as Group 1.
15765275|NCT04734288|Dietary Supplement|Vit.D3 5000 IU, Immune Active|"The subjects will receive monthly (for either 3 or 6 months):
~Vit.D3 5000 and Immune Active. The first phase includes 3 months of treatment and the second phase includes 6 months of treatment.
~An in-home Vit.D/ hs-CRP test kit and asked to self-administer a blood collection via fingerstick and return the kits for analysis within a few days.
~Two online questionnaires each month and asked to fill them out within a few days. It will either be the Medical Outcomes Study (MOS) Short Form (SF)-36 and the Health Status Baseline or Health Status Follow-up Questionnaire."
15765276|NCT04734275|Drug|AZD5718|Subjects will receive single doses of AZD5718 on 3 occasions, separated by at least 7 days washout, under fasted and fed conditions.
15765277|NCT04734262|Drug|Sitravatinib|Sitravatinib QD PO Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases
15765278|NCT04734262|Drug|Tislelizumab|Tislelizumab Q3W IV Tislelizumab is a programmed death receptor-1 (PD-1) blocking antibody
15765279|NCT04734249|Drug|Surufatinib(HMPL-012)|"Cohort 1:Surufatinib(250mg ,qd,po)+mFOLFOX6/FOLFIRI,14 days for a cycle.The curative effect was evaluated every 4 cycles.
~Cohort 2:Surufatinib(250mg ,qd,po)+FOLFOXIRI,14 days for a cycle.The curative effect was evaluated every 4 cycles.
~if the first-line chemotherapy was used FoLFOX ,the second-line is FOLFIRI,or the first-line chemotherapy was used FOLFIRI ,the second-line is FoLFOX.
~Second-line Surufatinib Combined With Chemotherapy in Advanced CRC."
15765280|NCT04734236|Diagnostic Test|New technique vs Xpert|New technique vs Xpert
15765281|NCT04734223|Diagnostic Test|Neuroimaging Findings in Patients With COVID-19|MR and BT Imaging
15765282|NCT04734210|Drug|0.02% Betamethasone Sodium Phosphate|topical corticosteroid solution
15765283|NCT04734210|Drug|0.04% Betamethasone Sodium Phosphate|topical corticosteroid solution
15765284|NCT04734210|Drug|Placebo|topical vehicle solution
15765285|NCT04734197|Drug|Combination of 0.3% Mycophenolic Acid and 0.01% Betamethasone Sodium Phosphate|combination of a topical immunosuppressant and a topical corticosteroid solution
15765286|NCT04734197|Drug|Placebo|topical vehicle solution
15765291|NCT04734197|Drug|Betamethasone Sodium Phosphate 0.01%|topical corticosteroid solution
15765292|NCT04734184|Diagnostic Test|DCFPyL|Single dose injection
15765293|NCT04734171|Behavioral|Digital social activity video intervention|A 150 seconds video aimed at encouraging the use of a digital device (i.e. not in person contact) to meet with friends during the COVID-19 pandemic. Two friends meet via zoom instead of in person and share their experiencing supporting each other.
15765294|NCT04734171|Behavioral|Informational sheet|An informational sheet to learn about the COVID-19 outbreak (standard).
15765295|NCT04734171|Behavioral|Stigma awareness video intervention|A video aimed at sensitizing participants to COVID-19 related stigma. A COVID-19 + individual share their experience.
15765296|NCT04734158|Other|corneal imaging|corneal imaging using AS-OCT
15765297|NCT04734145|Diagnostic Test|Breathprinting test|Consented, enrolled participants will undergo a breathprinting test (e-nose) during the presurgical visit and at the same facility as their presurgical or prebiopsy visit, before any attempt is made to obtain cytohistological diagnosis of the pulmonary nodule.
15765298|NCT04734132|Dietary Supplement|Moringa|Leaves of Moringa oleifera from an organic Iberian peninsula cultivar. A single lot was prepared from the same crop. Leaves were dried and ground and encapsulated as a organic dietary supplement. No other changes in diet or physical activity were included although a general healthy lifestyle pattern was recommended.
15765299|NCT04734132|Dietary Supplement|Placebo|Placebo capsules were indistinguishable from the experimental capsules in material and color (opaque white). Same number of capsules were consumed as in the experimental arm and no other changes in diet or physical activity were included although a general healthy lifestyle pattern was recommended.
15765300|NCT04734119|Other|Pre operative evaluation and anesthesia administration by the same anesthesiologist|Pre operative evaluation and anesthesia administration by the same anesthesiologist (instead of two different anesthesiologists, as routinely performed in our medical center)
15765301|NCT04734106|Drug|Desert Harvest Aloe Vera Capsules|600 mg pure, freeze-dried aloe vera super-concentrate with a minimum of 200 mg glycosaminoglycan per capsule.
15765302|NCT04734106|Other|Placebo Capsules|550mg of Avicel microcrystalline cellulose per two-piece, hard-shelled gelatin capsule.
15765303|NCT04734093|Diagnostic Test|Evaluation of sonographic signs of gouty arthritis|the EULAR scanning protocol for the knee and 1st MTP will be considered [2]. Further, scanning of the double contour sign over the femur condyles anteriorly and posteriorly in sagittal planes will be assessed. Examination of erosions, tophus, double contour, effusion, and echogenic foci will be recorded.
15765304|NCT04734080|Drug|Dronabinol 5mg Cap|Dronabinol is a synthetic tetrahydrocannabinol (THC) agent approved for nausea and vomiting with chemotherapy and as an appetite stimulant in AIDS patients.
15765305|NCT04734080|Drug|Placebo oral tablet|Non-active placebo
15765306|NCT04734067|Other|Immune checkpoint inhibitors(ICIs) therapy|Patients with malignant tumors who first received ICIs
15765307|NCT04734054|Device|Modified Hyrax Palatal Expander|The rapid maxillary expansion will be performed. The expansion should be accomplished between 10 to 15 days at most. The screw is going to be turned in a rapid manner.
15765308|NCT04734054|Device|Removable Palatal Expander|The slow maxillary expansion will be performed. The expansion will be performed in a slow manner. Patients may need between 6 to 8 months to achieve the required expansion.
15765309|NCT04734041|Behavioral|Anti-inflammatory (Mediterranean-style) diet|Prescription of an anti-inflammatory diet, which encourages increasing whole fruits, vegetables, and grains, as well as balancing macronutrients (proteins, carbohydrates, and fat) for every meal.
15765310|NCT04734041|Behavioral|Behavioral and psychosocial support|Capture a complete and detailed medical history and background. Discuss familial and social support, provide psychosocial support, assess the patient's current self-management strategies for self-care, and assess the patient's current self-management strategies for mental health. Recommendations will be made in accordance with the needs of the participant.
15765311|NCT04734028|Drug|Clopidogrel Tablets|DES-treated patients were treated with clopidogrel 75 mg daily and aspirin 100 mg daily
15765312|NCT04734015|Behavioral|Together Overcoming Diabetes (TOD)|Curriculum approaches health through a holistic lens of spiritual, mental, physical and emotional wellness. American Indian Family Health Coaches conduct motivational interviewing to help participant dyads (adult caregivers with Type 2 diabetes and their youth) set attainable goals and work through obstacles to reach those goals.
15765313|NCT04733989|Other|Biomarker Data Collection|During this study, a sample of your blood will be collected and you will have a PET scan taken of your brain. Blood sample results will be compared to PET scan pictures to understand how well the markers in the blood predict whether there is amyloid in the brain. Blood samples will also be collected that contain your genes. These genetic samples will also be compared to PET scans to help researchers understand how different people react to medicines and to understand the genetic causes of Alzheimer's disease. Some of the samples will be stored for future analysis.
15765314|NCT04733963|Drug|Fruquintinib Plus Capecitabine|Maintenance therapy with fruquintinib at the dose determined in phase safety lead-in, orally once daily, on d1-21, given every 4 weeks (Q4W); plus capecitabine at the dose 850mg/m2, orally twice daily, d1-7, given every 2 weeks (Q2W); until progressive disease, death from any cause, unacceptable toxicity or informed consent withdrawal
15765315|NCT04733963|Drug|Bevacizumab Plus Capecitabine|Maintenance therapy with bevacizumab at the dose 5mg/kg q2w (Q2W); plus capecitabine at the dose 850mg/m2, orally twice daily, d1-7, given every 2 weeks (Q2W); until progressive disease, death from any cause, unacceptable toxicity or informed consent withdrawal
15765316|NCT04733950|Other|Forced choice psychoacoustic task for the evaluation of modulation detection performance and selective auditory attention. (for both arm)|"Description:
~3-interval, 3-alternative forced choice amplitude modulation detection task using a target sinusoidal carrier and a spectrally distant, interfering (distracting), sinusoidal carrier that may or not be modulated at the same rate as the target."
15765317|NCT04733950|Other|Measurement of the pupil diameter for the evaluation of listening effort during speech perception|Pupil diameter is recorded using an eye-tracker device (Tobii Pro TX300) while the subject performs a 16-alternative consonant identification task both in silence and in the presence of interfering speech.
15765349|NCT04733664|Device|VFI using the FAST PV Technology|The bolus IV administered visible fluorescent injectate (VFI) agent is comprised of a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.
15765318|NCT04733937|Other|a2 Platinum® stage 1 infant formula|Upon randomization (if not included in the breastfed group), each participant will be provided with up to 105 days' supply of the standardized formula and up to 28 days' supply of the allocated formula. Participants and study investigators will conduct the trial via a pre-determined randomization schedule.
15765319|NCT04733937|Other|Conventional, A1 and A2 β-casein containing stage 1 infant formula|Upon randomization (if not included in the breastfed group), each participant will be provided with up to 105 days' supply of the standardized formula and up to 28 days' supply of the allocated formula. Participants and study investigators will conduct the trial via a pre-determined randomization schedule.
15765323|NCT04733911|Other|75 eccentric contractions|An acute bout of eccentric exercise will be performed on an isokinetic dynamometer, including 5 sets of 15 repetitions, with 30 sec rest intervals,at 60 degrees/sec.
15765324|NCT04733911|Other|150 eccentric contractions|An acute bout of eccentric exercise will be performed on an isokinetic dynamometer, including 10 sets of 15 repetitions, with 30 sec rest intervals,at 60 degrees/sec.
15765325|NCT04733911|Other|300 eccentric contractions|An acute bout of eccentric exercise will be performed on an isokinetic dynamometer, including 20 sets of 15 repetitions, with 30 sec rest intervals,at 60 degrees/sec.
15765326|NCT04733898|Other|SamenSpelen.app|An app designed to play simple, social games in a chat environment. These games are designed to elicit personal interaction.
15765327|NCT04733898|Other|FijnSpelen.app|An app designed to play simple, social games in a chat environment. These games are designed to not elicit personal interaction.
15765328|NCT04733885|Device|Experimental|Current application will be made in the frequency range of 20-50 Hz. The Chattanooga (Intelect Neo) device with interfering current will be used for treatment, vacuum electrodes will be made in the form of 4 pole application. Two electrodes to the outside of the inguinal ligament, the other two electrodes will be placed on the upper inner part of the thigh.ES applications will be performed in the supine position with head and knee pillow supported.
15765329|NCT04733885|Device|Control|The Chattanooga (Intelect Neo) device with interfering current will be used for treatment, vacuum electrodes will be made in the form of 4 pole application. Two electrodes to the outside of the inguinal ligament, the other two electrodes will be placed on the upper inner part of the thigh. The same device used in ES application to the sham group will be attached to the patients, however, active ES will not be issued from the device and only vacuum will turn on. ES applications will be performed in the supine position with head and knee pillow supported.
15765330|NCT04733872|Dietary Supplement|placebo|subjects drank 50 ml , 1 bottle a day for 8 week
15765331|NCT04733872|Dietary Supplement|Vegetable and Berry Drink|subjects drank 50 ml , 1 bottle a day for 8 week
15765332|NCT04733859|Dietary Supplement|placebo group|subjects drank 50 ml , 1 bottle a day for 8 week
15765333|NCT04733859|Dietary Supplement|red djulis drinks|subjects drank 50 ml , 1 bottle a day for 8 week
15765334|NCT04733846|Other|data collection|Collection of clinical and paraclinical data during preoperative consultation Collection of clinical and paraclinical data during post-operative consultations Tele-consultation to determine if criteria for good healing / adherence, treatment tolerance / response to questions Remote follow-up 6 and 12 months after the trauma
15765335|NCT04733833|Drug|VB-201 + Standard of care|Daily oral administration of VB-201- 160 mg (80 mg BID) with standard of care
15765336|NCT04733833|Drug|Standard of care|Standard of care
15765337|NCT04733820|Drug|Adjuvant chemotherapy|Drug: Paclitaxel or docetaxel + Cisplatin or carboplatin Paclitaxel 135-175mg/m2 over 3 hours or docetaxel 70-75 mg/m2， 30min ＋ Cisplatin 75-80mg/m2 or carboplatin AUC = 5, repeat per 21 days.
15765338|NCT04733807|Biological|BNT162b2 mRNA Covid-19 Vaccine|Hospital employers vaccinated with BNT162b2 mRNA against Sars-Cov2 are studied for serum antibody response.
15765339|NCT04733794|Procedure|Stoma reversal|Patients will receive a comprehensive intervention to addresses bowel, sexual, and urinary dysfunction. Patients meeting appropriate inclusion criteria will be approached at a clinic visit with their surgeon. If they agree to participate, they will complete an initial baseline questionnaire. Questionnaires will be distributed on iPads during their clinic visit
15765340|NCT04733781|Drug|Tumescent Lidocaine and Epinephrine|Subcutaneous injection of a relatively large volume (125ml to 250ml) of a relatively dilute solution of lidocaine (1gm/L) and epinephrine (1mg/L or 2mg/L).
15765341|NCT04733768|Diagnostic Test|18F-PSMA-1007|18f-PSMA-1007 PET/CT scan
15765342|NCT04733755|Dietary Supplement|Beauty Image|1.97g/package; 2 packages one day for 8 weeks
15765343|NCT04733755|Dietary Supplement|Placebo Control|Placebo Control; 1.97g/package; 2 packages one day for 8 weeks
15765344|NCT04733742|Drug|Tenecteplase|intravenous thrombolysis with tenecteplase followed by endovascular treatment
15765345|NCT04733742|Other|Endovascular treatment|endovascular treatment
15765346|NCT04733716|Procedure|Using Tourniquet|The purpose of this prospective randomized double blinded study was to compare the effect of using a tourniquet on early-stage pain and 1-year postoperative functional outcomes when patients were divided into two groups according to the pain threshold.
15765347|NCT04733703|Other|questionnaire|assessment of postoperative quality of recovery with the QoR-15
15765348|NCT04733690|Dietary Supplement|Common bean product|"Healthy volunteers Healthy volunteers in the GI and FII studies will participate in the study during 3 test days for each of the studies. The reference food will be tested 2 times and the test food 1 time in each participant.
~T2DM patients T2DM patients will participate in the study for one test day for the assessment of postprandial glycemic, insulinemic and satiety responses.
~For both healthy volunteers and T2DM patients, the following will be assessed during study days: 24-hour of dietary recall; weight, height, waist and hip circumferences; blood pressure; and body composition using bioelectrical impedance analysis (BIA). Participants will be fed with a portion of the test or reference food and 250ml water. Two fasting blood samples (-5 and 0 min) and postprandial blood samples (15, 30, 45, 60, 90 and 120 min) will be collected"
15765350|NCT04733651|Drug|Hospital standard of care for COVID-19|Standard care for COVID-19 as per the hospital guidelines
15765351|NCT04733651|Drug|Isoquercetin|Daily 1000 mg Isoquercetin as 4 capsules
15765352|NCT04733638|Device|Viz ICH VOLUME|Viz ICH VOLUME software is a module that identifies and segments Intraparenchymal Hemorrhage (IPH) from NCCT imaging. This software is for investigational use in the study and is not FDA cleared. For subjects who undergo a brain scan, Viz will use deep learning algorithms to analyze computed tomography (CT) or magnetic resonance (MR) images of the brain for ICH in parallel to standard of care image interpretation. If a suspected ICH is detected, Viz will perform an automatic volumetric analysis and will send a notification to a specialist, such as a neurointerventionalist or a neurosurgeon. Notifications prompt the specialist to review the patient's case. Additionally, non-diagnostic previewing of DICOM images, and HIPAA-compliant text messaging and phone calls are available in the software platform. Viz ICH VOLUME is not intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man.
15765353|NCT04733625|Drug|Cholecalciferol|single injection of Vitamin D (200000 I.U
15765354|NCT04733625|Drug|Placebo|placebo medication
15765355|NCT04733612|Other|Informative messages|"In addition to their standard treatments, an informative SMS (text message) on diabetes was sent to the intervention group three to four times a week for six months.
~The short messages were in the form of a short sentence for the subject and the predicate. The messages sent have been prepared in such a way that they do not exceed 1 SMS quota and are less than 160 characters on mobile phones."
15765356|NCT04733586|Procedure|Sonar guided fascia iliaca|Sonar guided fascia iliaca
15765357|NCT04733586|Procedure|Sonar guided quadratus lumborum block|Sonar guided quadratus lumborum block
15765358|NCT04733573|Device|Two different occlusal splints|Two different occlusal splints will be used for bruxism management, PPT would be evaluated twice - before and after 30 days of splint therapy using pressure algometer (FPX25, Wagner Instruments, US)
15765359|NCT04733560|Procedure|Pudendal nerve block|Vaginally administered pudendal nerve block of 10ml 0.25% Bupivacaine prior to making any surgical incisions.
15765360|NCT04733560|Procedure|Sham Pudendal nerve block|Vaginally administered pudendal nerve block of 10ml Normal Saline prior to making any surgical incisions.
15765361|NCT04733560|Drug|Bupivacaine Injectable Product|Used for pudendal nerve block in the intervention arm
15765362|NCT04733547|Procedure|Placement of a central venous catheter|The right internal jugular vein is located at the first rib level under ultrasound-guidance. Using an out-of-plane technique, a needle is introduced into the lumen of the vessel. The aspiration of blood into the syringe connected to the hub of the needle confirms the placement of the needle tip in the lumen. After the syringe is detached from the needle, a guidewire is advanced into the vessel lumen through the needle. A dilator is introduced over the guidewire and subsequently is removed. Then, a central venous catheter is introduced over the guidewire into the vessel lumen through the pathway expanded by the dilator. The catheter tip is placed in the superior vena cava by inserting the catheter as far as the distance between the edge of the right transverse process of the first thoracic vertebra and the carina, which is preoperatively measured on a posteroanterior chest radiograph.
15765363|NCT04733547|Device|Monitoring of central venous pressure|Following the placement of a central venous catheter, a fluid-filled system for monitoring central venous pressure is connected to the proximal lumen of the catheter. The reference transducer is placed at the level of 4/5 of the anteroposterior diameter of the thorax.
15765364|NCT04733547|Drug|Furosemide-induced hypovolemia before graft procurement|Patients fast from 10 pm the day before surgery. On the arrival at the operating room, an intravenous catheter for Plasmalyte infusion is placed into the right cephalic or basilic vein. The distal lumen of the central venous catheter is used for the infusion of 6% hydroxyethyl starch. Fluid requirements due to anesthesia, surgery, and no per os intake are not replaced by minimizing the administration of the fluids. Five minutes after the collection of the baseline data, 20 mg of furosemide is administered to promote diuresis for facilitating the venous outflow of the liver. An additional dose of furosemide 20 mg is given if the urine output is <1 ml/kg within 30 minutes after the first dose. Unless the second dose of furosemide produces >1 ml/kg of urine within 30 minutes, 40 mg of furosemide is administered. In the absence of effective diuresis (1 ml/kg within 30 minutes after each dose), the use of furosemide is abandoned and the patients are excluded from the study.
15765365|NCT04733547|Drug|Replacement of fluid loss after graft procurement|Immediately after the graft procurement, 500 ml of 6% hydroxyethyl starch are infused over 25 minutes. Afterward, Plasmalyte is infused at a rate of 10 ml/min until the end of surgery.
15765366|NCT04733547|Device|Monitoring of stroke volume variation|Following anesthesia induction, the right radial artery is catheterized. The catheter is connected to the EV1000 monitor (Edwards Lifesciences, Irvine, CA) through the FloTrac transducer (Edwards Lifesciences). The transducer is level with the one for central venous pressure monitoring. Using pulse contour analysis without external calibration, the stroke volume for each heartbeat is measured. At a 20-second interval, stroke volume variation is calculated as (maximum stroke volume - minimum stroke volume)/mean stroke volume.
15765367|NCT04733534|Drug|Dasatinib plus Quercetin|Dasatinib (100 mg/day) plus Quercetin (500 mg twice daily) on days 1, 2, 3, 30, 31, 32 taken orally under observation of the study nurse.
15765368|NCT04733534|Drug|Fisetin|Fisetin (20mg/kg/day) on days 1, 2, 30 and 31 taken orally under observation of the study nurse. Fisetin will be dispensed based on weight of 20 mg/kg/day on the four separate days.
15765369|NCT04733521|Drug|SC-43|SC-43 oral, every day of 21-day cycle
15765370|NCT04733521|Drug|Cisplatin|cisplatin 75mg/m2 on day 1 of 21-day cycle
15765371|NCT04733508|Drug|111In-DTPA-exendin-4|Injection of 111In-DTPA-exendin-4 and localization of the tracer in excised pancreatic tissue using autoradiography
15765372|NCT04733508|Drug|IRDye800CW-exendin-4|Injection of IRDye800CW-exendin-4 and localization of the tracer in excised pancreatic tissue using fluorescence microscopy
15765373|NCT04733495|Other|Counseling|Receive group-based behavioral counseling
15765374|NCT04733495|Behavioral|Dietary Counseling and Surveillance|Receive dietary counseling
15765375|NCT04733495|Other|Quality-of-Life Assessment|Ancillary studies
15765376|NCT04733495|Other|Questionnaire Administration|Ancillary studies
15765377|NCT04733495|Other|Resistance Training|Undergo personalized resistance exercises
15765378|NCT04733482|Behavioral|Cosmetic care|
15765690|NCT04730778|Diagnostic Test|serum creatinine and estimated glomerular filtration rate, on daily basis|Assess establishing criteria of CIN through a week after primary PCI
15765379|NCT04733469|Behavioral|Multimedia Psychoeducational Intervention|"The Multimedia Psychoeducational Intervention includes a multimedia educational video plus additional resources to reinforce the video content. The Multimedia Psychoeducational Intervention includes the following:
~A multimedia educational video about palliative care that is individually tailored to each patient's level of education and health literacy
~Take-home and online copies of the video for repeat viewing
~A video summary
~A question prompt list patients can use to ask clinicians more questions about palliative care
~Contact information and brochures for local palliative care programs"
15765380|NCT04733469|Behavioral|Enhanced Usual Care|"Enhanced Usual Care refers to usual care plus minor enhancement to improve quality and standardization. Enhanced Usual Care includes the following:
~Usual care
~A packet of flyers and handouts with general information on psychosocial oncology services derived from the American Society of Clinical Oncology (ASCO), Center to Advance Palliative Care (CAPC), and American Cancer Society (ACS)"
15765381|NCT04733456|Behavioral|Quality of life questionnaires|Mayo Clinic Score (UC) or HBI score (CD), short IBDQ73, *EQ5D-5L, *GAD-774, *PHQ-975, *PROMIS (Gastrointestinal Belly Pain), Multidimensional Assessment of Interoceptive Awareness (MAIA)77, *Pain Catastrophizing Scale, Pittsburg Sleep Quality Index (PSQI) and Fatigue Severity Scale (FSS) at baseline and 16 weeks after the start of anti-TNF therapy
15765382|NCT04733456|Device|NIRS|A TechEn NIRSOptix continuous-wave fNIRS system will be used to record changes in cerebral oxygenation, at a sampling rate of 25 Hz
15765383|NCT04733456|Other|Stool Collection|For assessment of the known biomarker fecal calprotectin, in addition to fecal bacterial and fungal microbiome
15765384|NCT04733456|Other|Blood and urine collection|for inflammatory markers and metabolomic [IMC] analysis
15765385|NCT04733443|Device|Biolimus|140 patients who met the inclusion/exclusion criteria for in-stent restenosis were enrolled and assigned to the Biolimus treatment group
15765386|NCT04733443|Device|SeQuent® Please Neo|140 patients who met the inclusion/exclusion criteria for in-stent restenosis were enrolled and assigned to the SeQuent® Please Neo treatment group
15765387|NCT04733417|Drug|SHR6390|SHR6390 is a novel small molecule inhibitor specifically targeting the CDK4/6 pathway.
15765388|NCT04733417|Drug|famitinib|Famitinib is a tyrosin-inhibitor agent targeting at c-Kit, VEGFR2, PDGFR, VEGFR3, Flt1 and Flt3.
15765389|NCT04733404|Device|Dragonfly Transcatheter Mitral Valve Repair System|To conduct edge-to-edge repair with Dragonfly System under the guidance of transesophageal echocardiography.
15765390|NCT04733391|Other|Quality of life questionnaire|"Quality of life will be evaluated using the child version of the VSP-A questionnaire, for patients aged 8-10 years and the adolescent version for those aged 11-17 years."
15765391|NCT04733378|Procedure|Peri-operative neurological monitoring|Pre- and post-operative cerebral MRI, standardized neurological examinations at 4, 12, 24 months and neuropsychological evaluation with a Bayley III test (Bayley Scale of Infant and Toddler Development, Third Edition) at 24 months.
15765392|NCT04733365|Other|ERIC protocol|ERIC protocol is an aerobic exercise protocol with 5 levels of intensity
15765393|NCT04733352|Other|acupuncture|to conduct acupuncture on different acupoints
15765394|NCT04733339|Behavioral|Secondary Prevention|behavioral changes in dieting and exercising up to one year after clinical discharge
15765395|NCT04733326|Drug|Ketorolac Tromethamine|final rinse with non-steriodal anti-inflammatory drug or cold saline during single visit endodontic treatment
15765396|NCT04733313|Procedure|ultrasound guıded quadratus lumborum block|Administering local aneshtetic agent with a block needle using the in-plane technique, bilaterally. Lumbar interfascial triangle, where the middle lumbar fascia joins the deep lamina of the posterior layer on the lateral border of the erector spinae was targeted as the optimal point of injection.
15765397|NCT04733300|Behavioral|Mindfulness-Based College for Young Adults|"MB-College (MBC) is a 9-week, 9 session curriculum providing systematic and intensive training in mindfulness meditation practices, applied to health behaviors relevant to young adults (18-29). The curriculum, which is based on the manualized and standardized Mindfulness-Based Stress Reduction (MBSR) curriculum is designed to teach participants how to integrate and apply mindfulness in their everyday lives to the range of challenges arising from medical and psychological conditions and life stresses.
~MBC will be administered live, online via a video conferencing platform to participants enrolled in the active arms of the study: (1) standard dose MBC and (2) low-dose MBC. Standard dose MBC meets once a week for 2.5 hours for 9 weeks, while low-dose MBC meets for 1.5 hours per week for 9 weeks. There is an all-day retreat that takes place around week six of the program that applies to both MBC programs."
15765398|NCT04733300|Other|Health Education for Young Adults|The health education control group will receive young adult-specific online health resources offered through www.youngwomenshealth.org and www.youngmenshealthsite.org. Both websites provide resources to improve mental and physical health, and include opportunities to ask health questions, and learn ways to improve mental and physical well-being.
15765399|NCT04733287|Other|High Intensity Interval Training of the Knee Extensors|"Subjects will perform intense, single leg knee extension exercise 3 times a week for 6 weeks. Specifically, subjects will be seated in a custom knee extension ergometer and perform single leg, dynamic knee extension (similar to single leg cycling) as they perform the exercise. After a 6 minute warm-up at ~20% of that leg's maximum aerobic power (determined during a graded exercise test of single leg knee extension), subjects will perform 4 bouts of 4 minutes at ~80% of maximum aerobic power. Recovery of 4 minutes at ~40% will occur between each bout of exercise. A cool down will be provided at the end of exercise. In total, subjects will perform 40 minutes of single leg knee extension exercise, 3 times a week for 6 weeks.
~Maximum aerobic power (determined by a graded exercise test) will be determined again at 3 weeks to appropriately adjust the training intensity."
15765400|NCT04733287|Other|Muscle Heat Therapy|Subjects will receive muscle heat therapy on the knee extensor muscles (short-wave diathermy) for 120 minutes for each visit. Specifically, subjects will lie supine while short-wave diathermy units (Megapulse II) will be placed on the quadriceps femoris and turned on to 800 pulses per second with a pulse duration of 400 microseconds. Our previous research (e.g. Hafen et al 2018- Repeated exposure to heat stress...) has indicated that this treatment raises muscle temperature to ~39C, a similar temperature induced by exercise.
15765513|NCT04732260|Drug|Letermovir|"Each patient will receive 1 tablet of Letermovir (240 mg or 480 mg /day) during 3 days before TOP.
~The first 5 included women will receive 240 mg. The 5 subsequent women will receive 480 mg.."
15765514|NCT04732247|Drug|Oxytocin nasal spray|Intranasal treatment with oxytocin via nasal spray (48 IU per dose)
15765401|NCT04733287|Other|Muscle Disuse|Subjects will undergo 2 weeks of limb immobilization (a model of muscle disuse). Specifically, a knee brace will be placed on one of the subjects' legs and bent to a flexion of 60 degrees to prevent the foot from touching the ground while standing. Subjects will given a pair of crutches and asked to ambulate on crutches for 2 weeks, avoiding bearing any weight with the immobilized leg.
15765402|NCT04733287|Other|Sham Heat Therapy|Specifically, subjects randomly assigned to the sham group will receive the same treatment as the heat group (same number of visits and set up with the heating units applied to leg for 2 hours each visit) except, unbeknownst to either group, the heating units will never be turned on for the sham group.
15765403|NCT04733261|Other|Diaphragmatic mobility|Therapist will manually make contact with Pisiform Hypothenar region and last three fingers among the underneath the costal cartilage of the 7th in the direction of 10 ribs. For the duration of participant's inhalation, the counselor drag softly within a upward course accompany the increase motion of the ribs. For the period of expiration, the counselor will deepens make contact with in the direction of the internal costal border. Taking place consequent breathing, the counselor wanted on the way to expand traction as well as slickly make deeper the contact.
15765404|NCT04733261|Other|Chest Physiotherapy|Patients allocated to the control group and interventional group received pulmonary rehabilitation two times a day beginning happening the day of entrance on the way to the intensive care unit. It consists of side-lying positioning with the head of the bed horizontal for at least 20 min with the most affected lung on chest x-ray positioned uppermost is also known as postural drainage, 4 sets of 6 cycles of expiratory chest wall vibrations , and airway suctioning at least three times through the endotracheal and tracheotomy tube disperse in the course of the management
15765405|NCT04733248|Other|Kinesiotaping group|"HOT PACK (10 MINTS)
~TENS(10 MINTS)
~STRETCHING EXERCISES(10 reps 3sets) hold for 2 sec
~Apply KINESO- TAPE on upper trapezius (from I-O for Inhibition purpose)
~HOME PLAN OF EXPERIMENTAL GROUP:
~SELF STRECHINGS (10 reps 3 sets)
~AROMS
~NECK ISOMETRICS (10 reps 3 sets)hold for 10 sec (In neck flexion, In neck extension, In side bending) In experimental group kinesiotape was applied on upper trapezius from insertion to origin for inhibition purpose. As it had increased the functional status of the patient. Post -intervention assessment was taken on 1 st, 2nd and 3rd visit."
15765406|NCT04733248|Other|stretching group|"HOT PACK (10 MINTS)
~TENS(10 MINTS)
~STRETCHINGS EXERCISES (10 reps 3sets) hold for 2 sec 5.9HOME PLAN OF CONTROL GROUP:
~SELF STRECHINGS (10 reps 3 sets)
~AROMS
~NECK ISOMETRICS (10 reps 3 sets)hold for 10 sec In neck flexion In neck extension In side bending Post-intervention assessment was taken on 1 st, 2nd and 3 rd visit"
15765407|NCT04733235|Drug|Progesterone|ultrasound measurements of endometrial thickness at the end of the estrogen phase and the day of embryo transfer.
15765410|NCT04733209|Other|TENS, US, exercise|Physiotherapy
15765411|NCT04733196|Drug|Essential oils|Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
15765412|NCT04733196|Drug|Essential oils in combination with chlorhexidine 0,12%|Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
15765413|NCT04733196|Drug|Placebo mouthwash|Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
15765414|NCT04733196|Drug|Chlorhexidine 0,20 % in combination with aroma oils|Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
15765415|NCT04733196|Drug|Prebiotic|Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
15765416|NCT04733196|Drug|Hydrogen peroxide 0,8 %|Participants were asked to rinse with 15 ml mouthwash twice daily for 21 days.
15765417|NCT04733183|Drug|Dacarbazine|Dacarbazine (DTIC), 1000 mg/m2 or 850 mg/m2 on Day 1 of every 21-day cycle (based on results and DSMB evaluation in the safety run-in part of the study)
15765418|NCT04733183|Drug|onfekafusp alfa|L19TNF, 13 μg/kg, on Day 1, 3, and 5 of every 21-day cycle for a maximum of 6 induction cycles. Patients experiencing apparent or real benefit with minimal or acceptable toxicity from the first 6 cycles of treatment, can receive, at investigator's discretion, maintenance treatment of 13 μg/kg, on Day 1 every 21-day
15765419|NCT04733170|Diagnostic Test|KnowNow SARS-CoV-2 Rapid Antigen Test|KnowNow SARS-CoV-2 Rapid Antigen Test for the detection of Covid-19 in saliva, as compared to high sensitivity reverse transcription polymerase chain reaction (RT-PCR) of nasopharyngeal swabs as the reference test method
15765420|NCT04733157|Drug|Tranexamic acid injection|Tranexamic 1g administered intravenously at the onset of skin incision at caesarean section
15765421|NCT04733157|Other|Normal saline placebo|10ml of normal saline will be administered intravenously at onset of skin incision at caesarean section to the placebo group
15765422|NCT04733144|Drug|Prednisolone|7,5 mg prednisolone (low dose) 30 mg prednisolone (high dose)
15765423|NCT04733144|Drug|Dexamethasone|1,125 mg dexamethasone 4,5 mg dexamethasone
15765424|NCT04733131|Drug|Conversion to a belatacept regimen|belatacept intravenous on Days 1, 15, 29, 43, 57 then every 28 days.
15765479|NCT04732572|Procedure|Adenotonsillectomy|Surgery will be performed by board-certified otolaryngologists with or without the assistance of resident physicians in accredited otolaryngology training programs. Prior to the surgical procedure, tonsillar size will be graded using a standardized scale of 0-4. Extent of adenoid tissue will also be graded as mild (0-33%), moderate (34-66%) or severely (67-100%) obstructing the posterior choanae. Complete bilateral tonsillectomy and removal of obstructing adenoid tissue will be performed by cold dissection, monopolar electrocautery or plasma knife-assisted surgical technique under general anesthesia. All procedures will be performed using inpatient facility for 3-4 days.
15765425|NCT04733118|Drug|Trastuzumab and Pertuzumab (FDC SC) and T-DM1|"Patients will receive Trastuzumab and Pertuzumab as a subcutaneous fixed-dose combination (PH FDC SC) (± ET depending on HR status) for 8 3-week cycles, on day 1 only. ET will consist of letrozole for post-menopausal women or tamoxifen ± ovarian function suppression (OFS) for pre-menopausal women administered continuously. Men will receive tamoxifen.
~After completing neoadjuvant therapy, a final breast MRI will be performed 2 weeks prior to surgery. Surgery will be performed within 4 weeks after completion of the last cycle of PH FDC SC.
~Adjuvant systemic therapy will start within 4 weeks from surgery. There will be three different cohorts depending on pathological report:
~Cohort A: PH FDC SC ± ET for 10 additional 3-week cycles
~Cohort B: T-DM1 ± ET for 10 cycles
~Cohort C: T-DM1 ± ET for 10 cycles, with possibility of physician's choice chemotherapy before adjuvant T-DM1."
15765426|NCT04733092|Drug|Lipiodol|Lipiodol in emulsion with contrast agent
15765427|NCT04733079|Other|Cleanweb electronic messaging ePro|Patient and their medecin will communicate regulary via Cleanweb electronic messaging ePro to adapt the posology of THU untill the target urecemia is reached
15765428|NCT04733079|Other|Usual follow-up|Adaptation and follow-up of ULT according to referring physician's habits
15765429|NCT04733066|Drug|Teduglutide|Intervention group consists of patients, who receive teduglutide within routine medical care
15765430|NCT04733053|Other|Diet plus exercise|"The diet program has two phases: 1) intensive weight loss through a ketogenic very low calorie diet VLCD, and 2) transition from ketogenic VLCD onto a healthy eating plan for weight maintenance. Meal replacements will be provided to participants free of charge from the start of the trial to a maximum of 14 weeks (12 weeks for the ketogenic diet and 2 weeks for transition). If a participant does not wish to transition off the ketogenic diet after 14 weeks but wants to continue or if they wish to recommence the ketogenic diet any time after week 14 they will need to purchase meal replacements themselves at their own cost.
~Participants will be encouraged to aim to lose at least 10% body weight."
15765431|NCT04733053|Other|Exercise|The trial coordinator will have provided participants with educational material about OA, handouts of home exercises including photographs and descriptions, a logbook for recording home program completion and resistance exercise bands ahead of their first appointment. Physiotherapists will prescribe 5-6 strengthening exercises from a pre-determined list to be performed at home three times/week, including two quadriceps exercises, one each for hip abductors, hamstrings and calf, and any other as appropriate. Review and modification will occur at each consultation to maintain moderate intensity (effort of ≥5 out of 10 (hard) on a modified Borg Rating of Perceived Exertion scale). The physiotherapist will also prescribe a personalised physical activity plan in collaboration with the participant that is supported and progressed over time.
15765433|NCT04733027|Combination Product|Dose escalation, first-in-human phase I clinical trial with an Expansion phase|PEP-010 will be administered on days 1, 2 and 3 every week, as a 3-hour intravenous infusion. Treatment will be administered until disease progression, unacceptable toxicity, death or withdrawal of consent, whichever occurs first. Each cycle will be of 21 days duration.
15765434|NCT04733001|Drug|HSG4112|Once-daily oral administration
15765435|NCT04732988|Drug|HSG4112|Once-daily oral administration
15765436|NCT04732988|Drug|Placebo|Once-daily oral administration
15765437|NCT04732975|Device|CardioFlux|Non-invasive screening for ACS
15765438|NCT04732962|Device|AposHealth|"AposHealth is comprised of a unique footwear (Apos device) and uses two convex pods called Pertupods, which are screwed into the plantar surface of the sole so that a person walks on these pods. A trained Apos therapist calibrates the devices. The location of the pods is adjusted according to the treatment methodology, depending on the needed effect on unloading the knee and with the purpose of potentially alleviating pain immediately."
15765439|NCT04732962|Procedure|Total Knee Replacement (TKR)|A total knee replacement occurs when a diseased or damaged knee joint is totally replaced with an artificial joint called an implant. The implant consists of high-grade metal and plastic components that fuse to the resurfaced bone. It is designed to move like a healthy human joint.
15765440|NCT04732949|Drug|SNG001|SNG001 nebuliser solution, 2 syringes each containing 0.65 mL once a day
15765441|NCT04732949|Drug|Placebo|Placebo nebuliser solution, 2 syringes each containing 0.65 mL solution containing excipients of the SNG001 solution
15765442|NCT04732936|Device|Temporary Peripheral Nerve Stimulator|Temporary Peripheral Nerve Stimulator to deliver 1-hr of electrical stimulation to injured nerves.
15765443|NCT04732923|Other|Assigned intervention - procedure|"This study is defined in 3 stages :
~STEP 1 : during the cardiac rehabilitation program over 4 weeks 6 minute walk test, questionnaires
~STEP 2 : monitoring at 6 months after cardiac rehabilitation program Nurse interview, 6 minute walk test, questionnaires
~STEP 3 : monitoring at one year after cardiac rehabilitation program Nurse interview, 6 minute walk test, questionnaires"
15765444|NCT04732910|Drug|Treatment with cystic fibrosis transmembrane regulator (CFTR) modualtors Ivacaftor, Lumacaftor-Ivacaftor, Tezacaftor-Ivacaftor, Elexacaftor-Tezacaftor-Ivacaftor|observational
15765445|NCT04732897|Procedure|dynamic dressing|Dynamic dressing is made by bandages of the foot with gauze pad, stretchable adhesive tape and elastic compression band
15765446|NCT04732884|Device|Sens2Go, Golex AG; w biofeedback|The Sens2Go is a CE certified 4-cell load sensor integrated in an insole that can be placed in any orthosis or cast. A threshold (10-50kg) can be defined at which - if higher loads are measured - an audio signal warns the patient of overloading (biofeedback). The device additionally registers loads from 0-100kg continuously.
15765447|NCT04732884|Device|Sens2Go, Golex AG; w/o biofeedback|Patients will not be warned by an audio signal in case of overloading. The device registers loads from 0-100kg continuously.
15765480|NCT04732533|Other|tDCS (transcranial direct current stimulation)|"Phase 1: The participant will receive 10, 20-minute sessions of tDCS on Monday-Friday, at approximately the same time of day, over two consecutive weeks.
~Phase 2: The participant will receive 22, 20-minute sessions of tDCS. 10 sessions will take place over the first two weeks on Monday-Friday, at approximately the same time of day. This will be followed by 3 tDCS sessions per week over four weeks.
~Phase 3: The participant will receive 156, 20-minute sessions of tDCS, 3 tDCS sessions per week over 52 weeks."
15765515|NCT04732247|Drug|Placebo nasal spray|Intranasal treatment with placebo via nasal spray
15765449|NCT04732858|Other|Cross sectional e-Survey on surgeons exposed to any educational intervention|"Educational intervention was considered as any procedure or program to facilitate the acquisition of basic skills about the disease, its ramifications and treatment2,6,7:
~Education in infectious disease, including
~pandemic training for health personnel
~Personal protective equipment (PPE) and protection.
~Specific speed-training focusing on environmental control (decontamination area, dressing...), personal protection, hand hygiene, sample management, risky gestures, control measures.
~Intensive care education:
~mechanical ventilation
~airways management
~emergencies and cardiovascular drugs
~Intensive care monitoring systems
~Basic nurse skills
~COVID-specific clinical management"
15765450|NCT04732845|Biological|Fully human anti CD19 CAR-T Cell Dose|"Level -1 (1 x 10^5 cells/kg) Level 1 [Starting Dose] (5 x 10^5 cells/kg) Level 2 (1 x 10^6 cells/kg) Level 3 (2 x 10^6 cells/kg)
~Infusion of CAR-T cells will occur over 5-30 minutes."
15765451|NCT04732845|Drug|Fludarabine|25 mg/m2 daily from day -5 to -3
15765452|NCT04732845|Drug|Cyclophosphamide|60mg/Kg on day -6
15765453|NCT04732819|Behavioral|High touch multi-pronged behavioral intervention|"In this intervention, facilities will work with our research team to accomplish the following:
~Identify and engage a Facility Opinion Leader.
~Employ Consenting Specialists to facilitate the clinical consent for vaccination process.
~Engage well respected persons in the community who are willing to provide messages that promote trust in the vaccine and that will be distributed widely within a facility by email, website, text and/or social media.
~Distribute buttons, T-shirts, and masks that promote awareness about vaccination (e.g., Ask me about the COVID-19 vaccine!) through facility leadership.
~Acquire additional COVID-19 testing kits using funds provided by our research team."
15765454|NCT04732806|Behavioral|Mightier video games|Biofeedback video game play in home
15765455|NCT04732793|Device|Hyruan ONE®|For use as a symptomatic treatment of osteoarthritis (OA) of the knee
15765456|NCT04732793|Device|Durolane®|For use as a symptomatic treatment of osteoarthritis (OA) of the knee
15765457|NCT04732780|Other|No intervention|No intervention
15765458|NCT04732754|Dietary Supplement|Aerobic exercise + Theobroma cocoa (AETC)|Daily consumption of 500mg cocoa in capsules and 3 sessions of physical exercise / week, 50 min / session, with moderate intensity of 50-70% of VO2peak for 8 weeks.
15765459|NCT04732754|Dietary Supplement|Control Group (CG)|Daily consumption of placebo capsules for 8 weeks
15765460|NCT04732754|Dietary Supplement|Aerobic Exercise (AE)|Daily consumption of placebo capsules and 3 sessions of physical exercise / week, 50 min / session, with moderate intensity of 50-70% of VO2peak for 8 weeks.
15765461|NCT04732754|Dietary Supplement|Theobroma Cocoa (TC)|Daily consumption of 500mg cocoa in capsules for 8 weeks.
15765462|NCT04732741|Diagnostic Test|Salivary Gamma-synuclein|Gamma-synuclein salivary levels measured using ELISA assay
15765463|NCT04732741|Diagnostic Test|Incisional biopsy|"A) Biopsy (reference standard): biopsy for group 1 will be performed by specialists in the national cancer institute.
~B) Biopsy for oral potentially malignant lesions will be performed by the candidate from the most representative region."
15765464|NCT04732741|Diagnostic Test|Conventional visual and tactile examination|Conventional visual and tactile examination using light and mirror
15765465|NCT04732715|Behavioral|CaRE Course|Participants will complete the CaRE Course over a 6-8 week time period. The curriculum of the CaRE course will include topics addressing caregiving for a PLWD during a pandemic, navigating the healthcare system for a PLWD, guiding and managing daily life, and self care.
15765466|NCT04732702|Other|no intervention|There will be no intervention.
15765467|NCT04732676|Other|Smartphone application|"Ecological Momentary Assessment (EMA)
~: ambulatory assessment of behaviors/symptoms in real-time on smartphones"
15765468|NCT04732663|Other|No Intervention|Cross-sectional study, no intervention.
15765469|NCT04732637|Diagnostic Test|"Test At Home's Proprietary Lollipop Buccal Cavity Swab"|"Self-collected Test At Home's proprietary Lollipop Buccal Cavity Swab with VTM."
15765470|NCT04732624|Drug|Oral Rehydration Solution|Feasibility study of Enteral-based resuscitation with Oral Rehydration Solution (ORS) vs standard-of-care Intravenous Fluid resuscitation for moderate-sized burn injuries in Nepal
15765471|NCT04732624|Drug|Lactated Ringer|Standard-of-care Intravenous Fluid resuscitation
15765472|NCT04732611|Other|Pilates exercises|Pilates group participants will perform 3 weekly Pilates sessions lasting approximately 50 minutes for 20 weeks.
15765473|NCT04732611|Other|Walking protocol|Walking group participants will perform 3 weekly walking sessions lasting approximately 50 minutes for 20 weeks.
15765474|NCT04732598|Drug|Paclitaxel + bevacizumab therapy|"The following regimen will be continued as a 28-day course until disease progression or the criteria for treatment discontinuation are met.
~[Paclitaxel] 90mg/m^2, day1,8,15, IV [Bevacizumab] 10mg/kg, day1,15, IV"
15765475|NCT04732598|Drug|Paclitaxel + bevacizumab + atezolizumab|"The following regimen will be continued as a 28-day course until disease progression or the criteria for treatment discontinuation are met.
~[Atezolizumab] 840 mg/body, day 1,15, IV [Paclitaxel] 90mg/m^2, day1,8,15, IV [Bevacizumab] 10mg/kg, day1,15, IV"
15765476|NCT04732585|Procedure|Physiotherapy or Surgery|"Physiotherapy: Guidelines suggest a tailored and progressive exercise program to improve muscle strength and control, joint mobility, and patient understanding of the problem and how to manage it. Additional interventions like tape or manual treatment can also be implemented but should not be exclusive
~Surgery: ACL surgical reconstruction"
15765477|NCT04732572|Behavioral|Sleep and healthy lifestyle education|Participants in both groups will receive age-appropriate standardized educational material for both Optimal Sleep Hygiene and Healthy Habits. Educational play will also be encouraged by providing take-home materials. Participant and parent/legal guardian (s) will be given verbal and written directions on the use of these materials at the time of the visit. Research Coordinators will encourage and track utilization of the sleep hygiene educational tools during the trial.
15765478|NCT04732572|Other|Other supportive care|Throughout the course of the trial participants identified by the principal investigator as having suboptimal asthma or rhinitis will be referred to their primary care physician for management and further treatment of these problems. All participants will receive a generic brand of an over-the-counter saline nasal spray to use as needed for nasal dryness and crusting. Proper use of the spray will be reviewed and demonstrated by the research coordinator at the baseline visit.
15765481|NCT04732520|Device|Pulsed electric field treatment using the Aliya System|pulsed electric field treatment of a single NSCLC tumor
15765482|NCT04732507|Combination Product|1% plain lidocaine and 0.25% plain bupivacaine|A 5- or 10-ml syringe will be filled equally with 1% plain lidocaine and 0.25% plain bupivacaine. A 1.5-inch 25-gauge needle will be attached to the syringe. The needle will be carefully inserted at the first trigger point and 2 mls of the mixed local anesthetic will be infiltrated. At that point, the needle will be carefully inserted into the trigger point based on the group assigned. Once needling is done for the first trigger point, the process will be repeated in exactly the same fashion for the remaining points.
15765486|NCT04732481|Procedure|passive leg lift test|passive leg lift test
15765487|NCT04732468|Biological|hAd5-S-Fusion+N-ETSD (Suspension for injection)|The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
15765488|NCT04732468|Drug|hAd5-SFusion+ N-ETSD (Oral capsule)|The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
15765489|NCT04732455|Drug|Lidocaine in Saline|Lidocaine IV infusion (2 mg/kg) in 200 ml saline over forty minutes with a maximum upper limit of 200 mg pre each chemotherapy session until end of the cycle.
15765490|NCT04732455|Drug|Duloxetine 30 MG|Oral Duloxetine tablet 30 mg once per day starting from the night pre chemotherapy during the whole period of chemotherapy cycle which expected to be three month
15765491|NCT04732455|Drug|Normal saline|200 ml normal saline over forty minutes pre each chemotherapy session until end of the cycle.
15765492|NCT04732442|Dietary Supplement|Immunonutrition|Impact Oral® Nestle, Switzerland
15765493|NCT04732442|Dietary Supplement|Standard Oral Nutritional Support|Fortimel Compact Protein® Nutricia, United Kingdom
15765494|NCT04732429|Drug|HST5040|Liquid solution
15765495|NCT04732429|Drug|Placebo|Liquid solution
15765496|NCT04732416|Drug|HM15136|Low dose of HM15136/ High dose of HM15136, SC injection, weekly
15765497|NCT04732403|Other|Patient Position|The patient will be placed in an angle on the surgical table during cystoscopy.
15765498|NCT04732390|Procedure|erector spinae block with bupivacaine|Patient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5
15765499|NCT04732390|Procedure|erector spinae block with bupivacaine and magnesium sulphate|Patient will receive 20ml 0.25% levobupivacaine + 0.7 mg/kg MgSo4 into interfascial plane below erector spinae muscle at level of T5.
15765500|NCT04732377|Procedure|erector spinae block with bupivacaine|"Group (A) (control group):
~Patient will receive 20 ml 0.25% levobupivacaine into interfascial plane below erector spinae muscle at level of T5."
15765501|NCT04732377|Procedure|erector spinae block with bupivacaine and dexmedetomidine|Patient will receive 20ml 0.25% levobupivacaine above + 1μ/kg dexmedetomidine into interfascial plane below erector spinae muscle at level of T5.
15765502|NCT04732364|Procedure|ultrasound guided erector spinae plan block using bupivacaine for modified radical mastectomy|Ultrasound guided Erector spinae plane (ESP) block will be given with patient in sitting position depending on surgical site (left or right) ESP block will be given using high frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to thoracic fifth spinous process, then Trapezius muscle, Rhomboidus major muscle, and erector spinae muscle
15765503|NCT04732364|Procedure|ultrasound guided erector spinae plan block with bupivacaine and Dexmetonidine for modified radical mastectomy|Ultrasound guided Erector spinae plane (ESP) block will be given with patient in sitting position depending on surgical site (left or right) ESP block will be given using high frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to thoracic fifth spinous process, then Trapezius muscle, Rhomboidus major muscle, and erector spinae muscle
15765504|NCT04732364|Procedure|ultrasound guided erector spinae plan block with bupivacaine and magnesium slphate for modified radical mastectomy|Ultrasound guided Erector spinae plane (ESP) block will be given with patient in sitting position depending on surgical site (left or right) ESP block will be given using high frequency linear u/s transducer, the probe is placed in longitudinal orientation lateral to thoracic fifth spinous process, then Trapezius muscle, Rhomboidus major muscle, and erector spinae muscle
15765505|NCT04732338|Other|Osteopathic Manipulative Therapy|Osteopathic Manipulative Therapy (OMT) is a non-pharmacological, noninvasive form of manual medicine. Osteopathic practitioners use a wide variety of therapeutic manual techniques to improve physiological function and help restore homeostasis in the body. There is a structural assessment is to identify possible abnormalities of tissue texture. Areas of asymmetry and misalignment of bony landmarks are also evaluated, along with the quality of motion, balance, and organization. These asymmetries, also known as somatic dysfunctions, are then treated by a variety of manual treatments, administered by osteopaths.
15765506|NCT04732325|Device|Spinal cord stimulation|Researchers will program the spinal cord stimulation (SCS) system to deliver, according to the randomization status of the participant, burst, kHz, tonic, and sham stimulation.
15765507|NCT04732312|Other|Home help|Setting up of a formal home help
15765508|NCT04732299|Other|MRI examination|Magnetic resonance thrombography is used to determine the location of thrombus, quantify the thrombus and determine its stage.
15765509|NCT04732286|Drug|Atezolizumab|Atezolizumab will be administered intravenously at a dose of 1200 mg on Day 1 of each 21-day cycle.
15765510|NCT04732286|Drug|Bevacizumab|Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.
15765511|NCT04732273|Other|Physical examination, diagnostic tests, laboratory tests|Physical examination, diagnostic tests depending on examined organ system (e.g. lung function test, echocardiography, audiometry), and laboratory tests (e.g. kidney parameter, hormonal levels).
15765512|NCT04732273|Other|Personal history, questionnaire|Personal history and focused questionnaires per organ system including symptoms, medication use, physical activity, and general wellbeing.
15765593|NCT04731545|Device|immediate implant placement|Minimally traumatic tooth extraction, immediate implant placement and hard tissue grafting. loading after 3 months.
15765516|NCT04732234|Procedure|Superior Hypogastric Plexus Block|Pre operative ultrasound guided superior hypogastric plexus block in pelvic surgeries using a curvilinear probe below umbalicus with needle in plane technique to reach the plexus in front of L5 vertebra
15765519|NCT04732208|Diagnostic Test|Colour fundus photography|Fundus images will be captured before and after administration of mydriatic agent
15765520|NCT04732195|Device|Pilocarpine microneedle patch|Each microneedle (MN) patch contains an array of solid, water-soluble, micron-scale needles that encapsulate the medication (Pilocarpine). The patch form can be placed directly on the skin.
15765521|NCT04732195|Device|Pilocarpine Iontophoresis|Pilocarpine Iontophoresis is a process of transdermal pilocarpine delivery by use of a voltage gradient on the skin. An agar gel disc containing pilocarpine is placed under the electrodes which are connected to the Macroduct 3700 Sweat Inducer device.
15765522|NCT04732182|Device|BrightGo cognitive training|Training on the BrightGo experimental device in the home
15765523|NCT04732182|Drug|Standard of Care medication for early Alzheimer's Disease|Participant takes 10 mg of Aricept daily or wears an Exelon 9.5 mg patch and is stable on one of these medications that were prescribed for diagnostic of early Alzheimer's Disease
15765524|NCT04732169|Drug|Active study drug ( oral CBD)|CBD in single dose syringes
15765525|NCT04732169|Drug|matching placebo|Placebo made with sesame oil flavored with strawberry flavoring in single dose syringes
15765526|NCT04732156|Biological|Blood sample|Measurement of PHI Index
15765527|NCT04732156|Other|Follow up questionnaire|3 years after inclusion
15765528|NCT04732156|Diagnostic Test|Human reading of prostate MR images (PI-RADSv2.1).|The PI-RADSv2.1 score will be compared to systematic and targeted biopsy findings (primary objective) and 3-year follow-up (secondary objective)
15765529|NCT04732143|Other|Inspiratory muscle training|At least 2 weeks prior to surgery, participants will be given a Vyaire incentive spirometer device and provided with formal training on proper inspiratory muscle breathing exercise using the device. They will be instructed to perform 4 sets of these exercises per day for 14 days prior to surgery.
15765530|NCT04732130|Behavioral|Time-Restricted Feeding|Participants are instructed to limit food intake to maximum 8 hours per day.
15765531|NCT04732130|Behavioral|Alternate Day Fasting|Participants are instructed to fast every other day.
15765534|NCT04732104|Drug|Lidocaine topical|intranasal spray anesthesia will be administered for achieving pulpal local anesthesia of maxillary anterior and premolar teeth. Xylometazoline OTC decongestant will be used to prolong the duration of anesthesia
15765535|NCT04732104|Drug|Lidocaine Hydrochloride|injectable local anesthesia will be administered to achieve pulpal local anesthesia of maxillary anterior and premolar teeth
15765536|NCT04732091|Procedure|Therapeutic ultrasound with 20 usec|A custom designed high mechanical index (MI) impulses at 4-20 usec and >1.0 mechanical index designed for the 1.8 MHz S5-1 transducer
15765537|NCT04732065|Drug|ONC206|Given orally (PO)
15765538|NCT04732065|Radiation|Standard of Care Radiation Therapy|Undergo RT
15765539|NCT04732052|Device|Transcranial Direct Current Stimulation|non-invasive brain stimulator
15765540|NCT04732039|Other|Measurement of peak oxygen uptake|Oxygen uptake measured on bike (pVO2) and during the conduction of specific daily life activities (ADL-VO2).
15765541|NCT04732013|Other|No clinical intervention is planned; study is observational|No intervention
15765542|NCT04732000|Drug|N-acetyl cysteine|Intravenous infusion started during the clinically indicated surgery at a rate of 50mg/kg over 1 hour followed by 50mg/kg over 3 hours. This will be an accumulated total of 100 mg/kg over 4 hours.
15765543|NCT04732000|Other|Normal Saline|Intravenous infusion at a time and rate to mimic the active treatment. The infusion will be given over 4 hours beginning during the clinically indicated surgery
15765544|NCT04731987|Behavioral|Beverage consumption|"Volunteers will consume, in random order, daily 330 ml of 1 experimental beverage per period (Orange Juice, Control Beverage, Control Beverage supplemented with hesperidin) for 6 weeks in each period.
~At the beginning and the end of each period, exploration will be conducted at fasted state and at post-prandial state after the administration of a high-fat high-sugar meal."
15765546|NCT04731961|Procedure|Standard of care (15 Botox injections)|The controls will be given the standard of care of 15 Botox injections.
15765547|NCT04731961|Procedure|Experimental Arm (5 Botox injections)|5 Botox injections will be given, with each injection containing three times the amount of Botox than each of the 15 injections given in the standard of care arm.
15765548|NCT04731948|Dietary Supplement|Folic Acid|400µg Folic Acid per day for 16 weeks
15765549|NCT04731948|Dietary Supplement|2 µg Vitamin B12|2 µg Vitamin B12 per day for 16 weeks
15765550|NCT04731948|Dietary Supplement|10 µg Vitamin B12|10 µg Vitamin B12 per day for 16 weeks
15765551|NCT04731948|Dietary Supplement|50 µg Vitamin B12|50 µg Vitamin B12 per day for 16 weeks
15765552|NCT04731935|Device|Sparrow Therapy System|Transcutaneous auricular neurostimulation
15765553|NCT04731922|Drug|TAK-510|TAK-510 solution.
15765554|NCT04731922|Drug|TAK-510 Placebo|TAK-510 placebo-matching solution.
15765555|NCT04731909|Drug|Toripalimab|Toripalimab 240mg,ivgtt,d1,q3w.
15765556|NCT04731909|Drug|Anlotinib|Anlotinib 12 mg/d,d1-14,q3w,4-6 cycles in total. In maintenance treatment period, Anlotinib 12 mg/d,d1,Oral for 2 weeks and stop for 1 week.
15765557|NCT04731909|Drug|Cisplatin|75mg/m2,d1,q3w,4-6 cycles in total.
15765558|NCT04731909|Drug|Carboplatin|AUC=5,d1,q3w,4-6 cycles in total.
15765559|NCT04731896|Procedure|Amniotomy|artificial rupture of the amniotic sac
15765560|NCT04731870|Other|Survey research|This is not an intervention study. It involves social science research of surveys and focus groups.
15765561|NCT04731857|Genetic|Retrospective data analysis|The outlined evaluation contributes to the improvement of molecular genetic diagnostics in patient care - for example when which diagnostics can be sensibly recommended for patients with which indications or not. Diagnostic gaps can be systematically evaluated and specifically addressed in the future. This potentially affects every examination assignment for current and future patients. In addition, the evaluation of the PRSs for example, can contribute significantly to the timely introduction to routine diagnostics. For familial breast cancer, according to the guidelines, there may be very specific preventive measures. Estimates currently assume up to 5% of patients, which would mean up to 25 cases per year with a potentially adapted management for patients with the question of a tumor disease alone.
15765562|NCT04731844|Drug|Curcumin plus Piperine|Curcumin with piperine is a well-tolerated over-the-counter supplement.
15765563|NCT04731818|Biological|ZB-06|ZB-06 is a polyvinyl alcohol-based film containing 20 mg of human contraceptive antibody (HCA) for topical intravaginal administration.
15765564|NCT04731805|Behavioral|Moving On After Breast Cancer|Patient education intervention that is evidence-based, physical therapy, patient & family centered through the use of face to face instruction, a booklet, and therapeutic exercise DVD. The education materials are designed to deliver information on short term, long term, and late physical and functional effects of breast cancer treatment and given to breast cancer survivors before beginning cancer treatment. The education materials are designed to be used before, during, and after breast cancer treatment.
15765565|NCT04731792|Other|Virtual Reality|a bronchial fibroscopy with a virtual reality helmet
15765566|NCT04731779|Drug|cannabidiol|Cannabidiol oral product formulated in MCT (medium chain triglyceride) oil
15765567|NCT04731779|Drug|Placebo|Placebo oral product formulated in MCT (medium chain triglyceride) oil
15765568|NCT04731766|Behavioral|Citrine 5 % sodium fluoride|Citrine varnish is a 5% sodium fluoride varnish, It was developed to prolong the contact between the tooth surface and fluoride to increase the resistance against caries attack and manage tooth hypersensitivity; the active ingredient of fluoride varnish is mostly 5% sodium fluoride.
15765569|NCT04731766|Behavioral|concocted nano-silver fluoride|Nano-silver fluoride (NSF) is a solution which has been introduced as an experimental formulation in which it's stability for three years has been proved by Santos et al. The laboratory synthesis of concocted NSF was carried out in a nano-technology center; Several trials were done until we have reached a successful end product.
15765570|NCT04731753|Device|mechanical debridement|The mechanical debridement is performed using the debridement pad Cutimed DebriClean. After the pad is moistened with wound-cleansing solution, the wound is cleaned using circular movements while applying gentle pressure.
15765571|NCT04731740|Drug|Lenvatinib|PO
15765572|NCT04731740|Biological|Pembrolizumab|IV
15765573|NCT04731740|Drug|Chemotherapy|Investigators' choice
15765574|NCT04731727|Drug|Riboflavin|Corneal cross linking achieved by combination of Riboflavin and ultraviolet light
15765575|NCT04731714|Device|Rhythmic median nerve stimulation|Square-wave 200 µs pulses triggered by computer at 12 Hz, at the threshold for thumb movement (expected ~2-15mA), applied to surface electrodes over the median nerve at the right wrist (conductive gel, 30 mm apart center-to-center, anode distal). This is a non-significant risk device study.
15765576|NCT04731714|Device|Arrhythmic median nerve stimulation|Square-wave 200 µs pulses triggered by computer at random intervals with a mean rate of 12 Hz (as described in Morera Maiquez et al., 2020), at the threshold for thumb movement (expected ~2-15mA), applied to surface electrodes over the median nerve at the right wrist (conductive gel, 30 mm apart center-to-center, anode distal). This is a non-significant risk device study.
15765577|NCT04731701|Diagnostic Test|Hemophilia Joint Health Score (HJHS)|Joint examination with Hemophilia Joint Health Score (HJHS)
15765578|NCT04731688|Behavioral|Weight Maintenance Group|The behavioral program is rooted in social learning theory and based on our existing prenatal intervention but with full food provision to ensure gestational fat mass loss is steady and closely supervised. Brief counseling sessions are designed to review self-monitoring records, reinforce adherence to the structured food provision program, problem-solve barriers, and provide additional support. Individuals will be provided with a structured meal plan designed to promote 25% calorie restriction during the second trimester followed by eucaloric intake during the 3rd trimester. Participants will be provided three meals and two snacks on 7 days at no cost.
15765579|NCT04731675|Biological|AMB-05X|A fully human monoclonal immunoglobulin (IgG2) directed against c-fms
15765580|NCT04731662|Behavioral|Short sleep|6-hours time-in-bed during weeknights
15765581|NCT04731662|Behavioral|Variable short sleep|Variable hours of time-in bed during weeknights
15765582|NCT04731649|Behavioral|Families Talking Together Plus (FTT +)|FTT + consists of three online intervention sessions of approximately 60-90 minutes each, that cover content from nine modules designed to teach parents effective communication skills, build parent-adolescent relationships, help parents develop successful monitoring strategies, and teach adolescents assertiveness, refusal skills, and how to use a condom correctly and every time.
15765583|NCT04731636|Device|G-Branch thoracoabdominal aortic stent system|Patients who meet all the inclusion criteria and don't meet the exclusion criteria will be implanted with thoracoabdominal aortic stent system.
15765584|NCT04731623|Drug|ION904|ION904 will be administered by SC injection.
15765585|NCT04731623|Drug|Placebo|Placebo (0.9% sterile saline) will be administered by SC injection.
15765586|NCT04731610|Other|Radiotherapy|postoperative radiotherapy after complete resection of thymoma
15765587|NCT04731610|Other|Surveillance after resection|Surveillance after tumour resection
15765588|NCT04731597|Drug|drug interaction|when two drugs are taken together
15765589|NCT04731584|Biological|Blood sample|Patients from 2 groups will undergo blood sample (during a blood sample for there care) and inflammation parameters will be measure the day of the stroke
15765590|NCT04731571|Radiation|CBCT-guided Adaptive Radiotherapy|The aim is to deliver adaptive radiotherapy using a CBCT-based radiotherapy delivery system.
15765591|NCT04731558|Drug|enoxaparin or tinzaparin or dalteparin|Thromboprophylaxis initiated approximately 14 hours prior to the planned liver resection skin incision. Thromboprophylaxis can be initiated using enoxaparin (20 - 40 mg), tinzaparin (2500 - 4500 IU), or dalteparin (2500 - 5000 IU), with the dose based on patient's renal function
15765592|NCT04731558|Drug|No intervention|No preoperative thromboprophylaxis.
15765594|NCT04731532|Procedure|classical respiratory physiotherapy with thoracic vibration|Classical respiratory physiotherapy application: Patient is positioned, postural drainage application is operated by tapping and trifled .
15765595|NCT04731519|Behavioral|Continuous Identity Cognitive Therapy (CI-CT)|CI-CT was developed as a manualized treatment integrating components of CBT and Acceptance and Commitment Therapy (ACT) with self-continuity and future-self related interventions to help Veterans develop a better present-to-the-future life story as a framework for increasing hopefulness, a sense of life meaning, empowerment, and an ability to attain future self-goals. The recovery oriented CI-CT for post acute suicidal episode Veterans includes eight components: 1) constructing a CI narrative, 2) mindfulness training, 3) life values identification, 4) developing a self-growth perspective, 5) identifying possible future selves - timelines, 6) connecting with the desired future self, 7) CI as context for current problems, and 8) moving toward the future self.
15765596|NCT04731519|Behavioral|General Health Education|General Health Education a structured manualized group health education intervention previously developed by VISN 2 MIRECC investigators as a control condition for group psychotherapy RCTs. It has 12 1.5-hour weekly group sessions focusing on health and wellness topics such as Sleep, Physical Activity, Impact of Stress, Relaxation Techniques, Substance Use, Nutrition, Managing Daily Activities, Medication Benefits and Side Effects. GHE was chosen for the AC because it aligns in many respects with CI-CT (e.g., group format, length of sessions, similar expectations) while diverging in specific topics and skills targeted allowing for control of common factors like attention without causing confounding due to overlap in concepts
15765597|NCT04731506|Behavioral|Family Connections|The program starts with 2 small group support sessions spaced one week apart that guides participants through developing an action plan; followed by 10 IVR calls (5-10 minutes) beginning with weekly (4), biweekly (4), and monthly (2) calls. During each IVR call parents provide information on current physical activities, and food consumption that is used to provide feedback on success in subsequent IVR calls.
15765598|NCT04731493|Other|Therapeutic Education Program|"needs assessment
~educational group workshop
~specialized workshops by age group: child / adolescent / transition / adult / entourage / separated parents and in parallel
~socio-administrative workshop
~individual summary (accompanied or not by his entourage / family)
~satisfaction questionnaire"
15765599|NCT04731480|Drug|Propofol|Propofol administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the closed loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of anaesthesia.
15765600|NCT04731480|Drug|Propofol|The target controlled infusion (TCI) pump will be programmed to marsh model with the target plasma site concentration of 3-µg/ml. The plasma concentration will be altered to maintain a target BIS of 50 during induction and maintenance of anesthesia
15765601|NCT04731480|Drug|Propofol|The target controlled infusion (TCI) pump will be programmed to Schneider model with the target effect site concentration of 3-µg/ml. The effect-site concentration will be altered to maintain a target BIS of 50 during induction and maintenance of anesthesia
15765602|NCT04731480|Drug|Propofol|Manual propofol administration will be done using an intravenous infusion pump to maintain a target BIS of 50 during induction and maintenance of anesthesia.
15765606|NCT04731454|Other|Control Diet (CD)|All food was provided to participants for the duration of the intervention (8 days), including prepared lunches and dinners and ingredients for breakfasts and snacks. A sugar-sweetened juice drink was provided for consumption of one portion per day. Water, milk, coffee, tea and alcohol were consumed as usual.
15765607|NCT04731454|Other|Healthy Nordic Diet (ND)|All food was provided to participants for the duration of the intervention (8 days), including prepared lunches and dinners and ingredients for breakfasts and snacks. Water, milk, coffee, tea and alcohol were consumed as usual.
15765608|NCT04731441|Behavioral|Home-based Exercise Program Prior to CRS-HIPEC|Exercise Program Subjects randomized to the intervention arm should have 6 weeks of home exercise prior to surgery, with a minimum of 5 weeks and not more than 7 weeks. The program will begin with an exercise consultation appointment with a certified fitness professional. During this consultation participants will receive an exercise manual for individualized home-based exercise and a practical introduction by an exercise and cancer specialist. PowerBlock adjustable dumbbells will be used for resistance training exercises and walking or jogging will be the primary type of aerobic training. The current program design was developed and successfully used with women with breast cancer. Thus, some components may need modification for this group of patients with advanced GI cancer.
15765609|NCT04731441|Behavioral|Exercise Education|Control arm: Subjects randomized to the control arm will receive education and a handbook on the benefits of exercise and will be encouraged to have adequate protein in their diet and provided with the list of high protein foods and nutritional information. These subjects will undergo the same assessments as the intervention arm at all time points. Control subjects will be offered a 6-week home exercise program 3 months after CRS/HIPEC, as described in sections 7.2.1-7.2.3. Results and outcomes will not be recorded.
15765610|NCT04731428|Behavioral|Progressive Relaxation Exercise|Progressive Relaxation Exercise involves stretching sixteen muscle groups while breathing in sequentially, relaxing while exhaling. Exercise can be from head to toe or from foot to head. In order for the technique to be effective, it is important to have affective (music, etc.) and visual aids. During the exercise, the patient should complete the processes of perceiving the tension in his body, maintaining control and getting into a state of relaxation. After the patient is informed about the exercise, the person starts with breathing exercises. A deep but relaxing breath is taken from the nose, and lips are given by contracting simultaneously with relaxation. During this application, the patient keeps contracting the muscle group that he exercises for 10 seconds; the nurse provides the patient to notice the temperature / warming felt in the muscle group.
15765715|NCT04730609|Drug|Dexmedetomidine|Doses of dexmedetomidine will be selected according to a sequential up-and-down method, using a biased coin design to find the estimated dose at which 90% of patients would have desired effect
15765611|NCT04731415|Device|Optical coherence tomography and optical coherence tomography angiography (Optovue®)|"Optical coherence tomography and optical coherence tomography angiography (Optovue®) were performed in each trimesters and at 6 weeks after childbirth.
~st trimester : gestational age 8-12 weeks
~nd trimester : gestational age 24-28 weeks
~rd trimester : gestational age 34-38 weeks"
15765612|NCT04731402|Other|Acupressure, laughter yoga and mindfulness stress reduction program|Initiatives will be applied to the experimental group. only measurement tools will be applied to the control group
15765613|NCT04731389|Behavioral|internet-based cognitive-behavioral therapy|Composed of 4 modules: the first module will address psychoeducation on dermatillomania, self-monitoring of symptoms and habit reversal techniques; the second module works with anxiety coping techniques (diaphragmatic breathing and muscle relaxation); module 3 addresses cognitive correction techniques, such as stopping thinking, analyzing evidence, reassigning severity and responsibilities; the last module reviews the techniques learned and addresses techniques for preventing symptom relapse. The modules will be applied by the patient in an online format, each module lasts an average of 30 minutes. The platform will send notice by email through automation tools, SMS or message by application to patients to remind them to complete 1 module per week.
15765614|NCT04731389|Behavioral|Quality of life improving intervention|consisting of videos with guidance on quality of life, with a total of 4 videos of 2 minutes, each being made available in 1 week, consisting of: guidance on sleep hygiene; guidance on healthy eating; guidelines on the practice of physical activity and guidelines on the excessive use of social networks.
15765615|NCT04731376|Other|Best Practice|Receive standard peri-operative care
15765616|NCT04731376|Procedure|Quality-of-Life Assessment|Ancillary studies
15765617|NCT04731376|Other|Questionnaire Administration|Ancillary studies
15765618|NCT04731376|Drug|Testosterone Cypionate|Given IM
15765619|NCT04731363|Dietary Supplement|xylitol|Intervention is a drink consisting of 300mL of water containing 30g of xylitol as a single oral dose.
15765620|NCT04731363|Dietary Supplement|erythritol|Intervention is a drink consisting of 300mL of water containing 30g of erythritol as a single oral dose.
15765621|NCT04731350|Device|radial extracorporeal shock wave|Radial shock wave device, Swiss DolorClast (EMS Electro Medical Systems, Nyon, Switzerland)
15765622|NCT04731350|Device|iontophoresis|Iontophoretic drug delivery system (phoresors II auto model PM850 IOMED):
15765623|NCT04731350|Other|Exercise|strengthening exercise
15765624|NCT04731337|Device|Digital Caliper (Shenzhen Jiabaili Electronic Commerce Co., Ltd)|Measuring the vertical distance between the tip of the upper and lower canine teeth.
15765625|NCT04731324|Drug|ZYIL1 capsule|NLRP3 inflammasome inhibitor
15765626|NCT04731311|Device|Usability evaluation of BrightGo computerized device for cognitive therapy of individuals with early Alzheimer's Disease|4 participants with undergo 4 usability evaluations each, inter-spaced by days when researchers will address design changes. 2 participants will be elderly healthy and 2 will have the early Alzheimer's disease. Each session will last up to 1 hour, during which participants will interact with tasks in the form of games. Games will be gradated in level of difficulty, increasing from session to session. They will be played with one game controller or with two controllers while participants wear an all-in-one head mounted display. The degree of cognitive engagement during tasks will be measured with custom biosensors and used in adjusting level of difficulty. Each participant will fill subjective evaluation form and a USE form assessing ease of use, usefulness, and perceived technology issues. Scores will be analyzed and data published, in conjunction with game performance data.
15765627|NCT04731298|Drug|Emapalumab|"Emapalumab (previously referred to as NI-0501, trade name Gamifant®) is a fully human immunoglobulin G1 (IgG1) anti-IFNγ monoclonal antibody that binds to and neutralizes IFNγ. Emapalumab binds to both soluble and receptor (IFNγR1)-bound forms of IFNγ.
~Emapalumab is in development for treatment of primary and secondary HLH. The benefit expected from the targeted neutralization of IFNγ by emapalumab has been validated by the recent FDA approval of emapalumab for treatment of patients with pHLH who have refractory, recurrent or progressive disease or intolerance with conventional HLH therapy. The safety profile has been assessed as acceptable.
~Emapalumab will be administered by intravenous infusion over 1 to 2 hours, depending on the volume of the infusion. The first infusion must be performed within 12 hours after CXCL9 levels have been measured above defined threshold. Treatment will last until maximum dose 15 (up to 56 days) or until evidence of engraftment, whichever comes first."
15765628|NCT04731285|Diagnostic Test|Pressure wire fractional flow reserve|Pressure wire is inserted into coronary arteries. The ratio of the average distal pressure and average aorta pressure is FFR.
15765629|NCT04731285|Diagnostic Test|CFD-based RuiXin-FFR|"CT-FFR was evaluated in a blinded fashion with a Coarse-to-Fine Subpixel algorithm for lumen contour"
15765630|NCT04731272|Drug|Dulaglutide 0.75Mg/0.5Ml Inj Pen|Randomized, open-label, cross-over study of 6 weeks exposure to dulaglutide 0.75 mg subcutaneous weekly or observation.
15765631|NCT04731259|Drug|ATR-04|ATR-04 is a proprietary formulated product containing lyophilized SEΔΔΔ, a Staphylococcus epidermidis genetically modified to be auxotrophic to D-alanine as the active ingredient.
15765632|NCT04731259|Other|Placebo|Placebo
15765633|NCT04731246|Other|Video-oculography / Neuropsychological evaluations|Annual evaluation: Medical history; Clinical, Neurological and Neuropsychological evaluations; Video-oculography examination; Inventory of examinations carried out in routine care (brain MRI, cerebral DaTScan, cerebral F-Dopa PET/CT scan, MIBG myocardial scintigraphy, blood test). Follow-up is carried out over 7 years.
15765634|NCT04731233|Biological|Plasma Rich in Growth Factor (PRGF) Supplementation|After rinsing the joint, the TMJ will be injected with blood plasma rich in growth factors (PRGF). PRGF supplementation which is an autologous platelet-enriched plasma obtained from patient's own blood, which after activation with calcium chloride allows the release of a pool of biologically active proteins that influence and promote a range of biological processes.
15765635|NCT04731233|Drug|Triamcinolone Acetonide|After rinsing the joint, the TMJ will be injected with 40 mg of triamcinolone acetonide with 5 mg bupivacaine.
15765636|NCT04731207|Device|Optovue®|Optical coherence tomography and optical coherece tomography angiography
15765662|NCT04730999|Drug|Bevacizumab|"Induction phase: 7.5 mg/kg on day 1, for a maximum of 6 cycles (each one of 21 days duration). Intravenous administration.
~Maintenance phase: 7.5 mg/kg on day 1, for a maximum of 12 cycles (each one of 21 days duration). Intravenous administration.
~In both phases, the treatment will continue until progression of disease, unacceptable toxicity, patient refusal."
15765637|NCT04731194|Behavioral|Performance-based financial incentive program|"Enhance policy awareness through verbal communication with patients, distributing picture-rich fliers to patients, and putting up large posters in public places of the villages.
~Support patients' registration in the reimbursement system
~Follow-up patients after the first, third, and sixth months after the start of the study, measuring blood pressure and blood glucose level. Encourage patients to purchase medications from public institutions and to take their medications on time.
~Receive financial incentives based on performance in the amount of 3 RMB per patient enrolled (first month) and 5 RMB per patient (at third and sixth month) buying medications with reimbursement from the policy."
15765638|NCT04731181|Behavioral|mobile application (little lovely dentist).|mobile application
15765639|NCT04731168|Device|Mandibular advancement device|Patients will have a mandibular advancement device during the first postoperative night
15765640|NCT04731155|Drug|PCSK9 inhibitor （Alirocumab）plus standard medications|PCSK9 inhibitor（Alirocumab） was giving to subjects before PPCI and continued twice a month until 3 month after AMI
15765641|NCT04731155|Drug|standard medications|standard medications was giving to subjects according guidelines
15765642|NCT04731142|Device|Huma|V. Digital remote patient monitoring using blood pressure and blood sugar devices in combination with a smartphone application ('the Huma app'). Participants are provided with home monitoring devices and download the Huma app. Participants are shown how to use the devices, how to input measurements into a smart phone and how to set personal goals. Data recorded via the Huma app is self-reported and includes activity data, diet information, blood glucose measurements, blood pressure measurements, weight, and the Diabetes Distress Scale (a self-reported questionnaire used to measure distress related to living with diabetes).
15765643|NCT04731142|Behavioral|Video group consultations|"Each patient is invited to attend a total of three VGCs during the 12-weeks lasting approximately one hour and 15 minutes each. Each session is facilitated by a Practice Nurse (PN) and consists of 6-10 people with T2DM. The self-reported Huma app (see below) and patient EPR data are used to populate a Discussion Dashboard which is used in each VGC to facilitate discussion. During the first VGC session, patient goals are discussed and adjusted in a group setting with topics relevant to their condition covered by the PN. Between each VGC session, patients spend time working on their goals and continuing to enter self-reported metrics into the Huma app. During the second and third VGC sessions, each patient is discussed, along with their performance against agreed goals. The PN also uses pre-prepared content to discuss topics relevant to managing diabetes (e.g., staying motivated, low carb diets)."
15765644|NCT04731142|Behavioral|KNOW Diabetes|Each patient is signed up to a series of educational email campaigns to complement the VGC sessions and provide broader education around diabetes management. Patients receive two emails per week during the 12-week service on a variety of topics.
15765645|NCT04731142|Other|Standard of care|Normal primary care service provided to matched control group.
15765646|NCT04731129|Device|Probe based confocal laser endomicroscopy of the pleura|Every patient referred for medical thoracoscopy will be screened. The pCLE of the pleura will be performed 2 times. First, just before the thoracoscopy, through the Boutin's needle or the thoracentesis catheter and second through the working chanel of the pleuroscope. This last acquisition allows visual control to target the pleural endomicroscopy assessment. These two acquisitions will be compared between each other and with the histological samples of the pleuroscopy.
15765647|NCT04731116|Drug|Cannabidiol|Oral Cannabidiol 150 mg twice daily during 14 days
15765648|NCT04731103|Drug|Abacavir (ABC)|Tablets or oral solution
15765649|NCT04731103|Drug|Lamivudine (3TC)|Tablet or oral solution
15765650|NCT04731103|Drug|Abacavir (ABC)+Lamivudine (3TC)+Zidovudine (AZT)|Tablet or oral solution
15765651|NCT04731090|Drug|IV fluoroquinolone 1 hour preoperatively and oral antibiotics for 24h postoperatively.|IV fluoroquinolone 1 hour preoperatively and oral antibiotics for 24h postoperatively.
15765652|NCT04731090|Other|Urine culture, antibiotic prophylaxis and hydrophilic-coated ureteral access sheaths|Patients had urine culture 10 days before the procedure. In addition to the antibiotic prophylaxis, hydrophilic-coated ureteral access sheaths were systematically used.
15765654|NCT04731064|Procedure|HAL (Hemorrhoidal Artery Ligation) - RAR (Recto-Anal Repair)|The patient is operated on in the first perineal position, under general anesthesia or under locoregional or even local anesthesia, after rectal preparation by simple enema. The HAL equipment included a disposable transparent rectoscope fitted near its end with a centimeter window through which wire stitch ligatures will be made. A light source facilitating the exposure of the internal face of the rectum and a Doppler transducer secured to the base of the rectoscope containing the Doppler system. Everything is connected to a generator which transmits Doppler noises to the surgeon. A printer on the generator makes it possible to map ligatures and note the depth of linked arteries. Equipment includes needle holder, knot pusher, scissors and dissecting forceps. The material for HAL is identical, except for the disposable rectoscope which is more indented at its end and on one side.
15765655|NCT04731051|Drug|HCQ01|HCQ01 is a sterile, clear and colorless, ready-to-use aqueous nebulizer solution. Hydroxychloroquine sulfate administered via nebulization
15765656|NCT04731051|Drug|standard of care (SOC) for COVID-19|Standard of care (SOC) for COVID-19
15765657|NCT04731038|Drug|Anlotinib, Toripalimab, Paclitaxel, Cisplatin/ Carboplatin|This is a single-arm study with all patients receiving these four drugs.
15765660|NCT04730999|Drug|Etoposide|Induction phase: 100 mg/sqm on days 1-3, for a maximum of 6 cycles (each one of 21 days duration). Intravenous administration. Treatment will continue until progression of disease, unacceptable toxicity, patient refusal.
15765661|NCT04730999|Drug|Carboplatin|Induction phase: AUC 5 on day 1 for a maximum of 6 cycles (each one of 21 days duration). Intravenous administration. Treatment will continue until progression of disease, unacceptable toxicity, patient refusal.
15765716|NCT04730596|Drug|Ketamine|Ketamine at a dose of 0.3 mg/kg dissolved in normal saline.
15765663|NCT04730999|Drug|Atezolizumab|"Induction phase: flat dosing of 1200 mg on day 1, for a maximum of 6 cycles ( each one of 21 days duration). Intravenous administration.
~Maintenance phase: flat dosing of 1200 mg on day 1, for a maximum of 12 cycles (each one of 21 days duration). Intravenous administration.
~In both phases, the treatment will continue until progression of disease, unacceptable toxicity, patient refusal, loss of clinical benefit."
15765664|NCT04730986|Behavioral|ED GOAL Nursing|A brief (<7minutes) interview by an emergency department nurse to empower patients to formulate and communicate their goals for medical care with patients' outpatient clinicians.
15765665|NCT04730973|Drug|Evolocumab|Evolocumab 140 mg s.c. every two weeks on top of optimal lipid lowering therapy
15765666|NCT04730973|Other|lipid-lowering therapy (LLT)|lipid-lowering therapy (LLT)
15765667|NCT04730947|Drug|Dapagliflozin|10 mg orally once a day
15765668|NCT04730947|Drug|Placebo|Taken orally once a day, the placebo looks identical to the study drug but it contains no active ingredient
15765669|NCT04730934|Other|Perceived stress scale|Perceived stress scale (PSS) : The PSS is a validated 10-item self-report questionnaire which asks individuals to indicate how often they have found their lives unpredictable, uncontrollable, and overloaded in the last month. The higher scores indicating greater perceived stress.
15765670|NCT04730934|Other|Fibromyalgia impact questionnaire|Fibromyalgia impact questionnaire (FIQ): The FIQ is composed of 10 items. The first item contains 11 questions related to physical functioning - each question is rated on a 4 point Likert type scale. Items 2 and 3 ask the patient to mark the number of days they felt well and the number of days they were unable to work (including housework) because of fibromyalgia symptoms. Items 4 through 10 are horizontal linear scales marked in 10 increments on which the patient rates work difficulty, pain, fatigue, morning tiredness, stiffness, anxiety and depression.
15765671|NCT04730934|Other|The drugs used before and during the pandemic, the patient's job status, physical activity conditions, pain status|"Drug using: Antidepressant, SNRI, gabapentin, SSRI, myorelaxan, nsaid, paracetamol, pregabalin, tramadol, food supplement.
~Job status: Participants were questioned about their occupational status before and during the pandemic as I am a housewife, I quit my job, I worked from home, I worked part-time and there was no change in my job.
~Physical activity: I do not have physical activity, I do my daily work at home, I do daily walks, I exercise regularly.
~Pain status: Participants were questioned that their pain conditions before and during the pandemic were much worse, worse, a little bad, no change, a little good,  better, It was questioned as much better."
15765672|NCT04730921|Device|Left bundle branch area pacing|Left bundle branch area pacing(LBBAP) is a novel physiological pacing form for ventricular pacing. In patients received LBBAP, the pacing lead will be placed at left bundle branch area to achieve narrow paced QRS duration.
15765673|NCT04730921|Device|Right ventricular pacing|Right ventricular pacing is the traditional pacing modality for ventricular pacing. The pacing lead was placed in the apex or septum of right ventricle.
15765674|NCT04730908|Other|DENTIFRICE|GEL -DENTIFRICE FOR BRUSHING TEETH
15765675|NCT04730895|Drug|Oral 13 cis retinoic acid|Dose of 0.5 mg/kg/day in 2 divided doses orally for 14 days
15765676|NCT04730895|Drug|Aerosolized 13 cis retinoic acid|Dose of Aerosolized 13 cis retinoic acid in gradual in 2 divided doses increases froms 0.2 mg/kg/day to 4 mg/kg/day
15765677|NCT04730895|Combination Product|13 cis retinoic acid doses orally in combination with spike protein based vaccine|Dose of 13 cis retinoic acid (0.5 mg/kg/day in 2 divided doses orally for 14 days and also, participants will receive two doses of 5-7.5x10^10 vp spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine in deltoid of non-dominant arm, 28 days apart
15765678|NCT04730895|Combination Product|Aerosolized 13 cis retinoic acid in combination with spike protein based vaccine|Dose of Aerosolized 13 cis retinoic acid in gradual in 2 divided doses increases from 0.2 mg/kg/day to 4 mg/kg/day for 14 days and also, participants will receive two doses of 5-7.5x10^10 vp spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine in deltoid of non-dominant arm, 28 days apart
15765679|NCT04730895|Biological|Biological: spike protein based vaccine such as ChAdOx1 nCoV-19 vaccine|Dose of 5-7.5x10^10vp of spike protein based vaccine such as ChAdOx1 nCoV-19 in deltoid of non-dominant arm, 28 days apart
15765680|NCT04730882|Dietary Supplement|Mixed Meal|the meal will be 40% of each subject's daily estimated caloric need, with 50%, 30%, 20% from carbohydrates, fat and protein, respectively
15765681|NCT04730869|Other|Standard Treatment Plus Metabolic Therapy Program|"See description under Arms."
15765682|NCT04730856|Drug|Tinzaparin|"day subcutaneously • Follow-up phase 1 (Day 15 to day 30): The information is obtained at discharge and on day +14, + 28 on 30 days. The latter information is obtained from patients, from medical records or by telephone contact at the patient's home.
~• Follow-up phase 2 (At 3 months: Information is obtained from patients, medical records, or by telephone contact at the patient's home."
15765683|NCT04730843|Drug|ES102|ES102 is administered via intravenous injection once every 21 days, every 21 days as a treatment cycle.
15765684|NCT04730830|Other|Questionnaire|Patients completing emergence assessment questionnaires at the time of the first dressing placement, as well as at the scheduled weekly placement. As part of a planned repair, the emergence will be assessed at most once a week, preferably at the beginning of the week by the patient. In any other case of dressing change, an emergence assessment will be requested.
15765685|NCT04730817|Device|Virtual Reality Motor-Cognitive Training System|Immersive VR training system tailor-made for the daily living experiences in the Hong Kong context to provide interactive experiences for older people in Hong Kong. The VR training system is designed as a game with 16 progressive levels (anticipating intervention group participants to complete 2 levels per week for 8 weeks) which aim to train their motor and cognitive functions.
15765686|NCT04730804|Drug|ALXN1830|ALXN1830 will be administered as SC infusion(s).
15765687|NCT04730804|Drug|Placebo|Placebo will be administered as SC infusion(s).
15765688|NCT04730791|Diagnostic Test|Algo(s)rithm|Specialized Algorithm for the categorization of Central Sensitisation. The algorithm is completed by the healthcare professional and includes questions about the patient's clinical picture.
15765689|NCT04730791|Diagnostic Test|Pressure Pain Threshold|The pain pressure threshold (PPT) is used to measure the sensitivity of specific areas. The test quantifies the minimum amount of pressure in a given area, during an increasing skin pressure stimulus, which is capable of altering the feeling of pressure in pain.
15765717|NCT04730596|Drug|Dexmedetomidine|Dexmedetomidine at a dose of 0.5 ug/kg dissolved in normal saline.
15765691|NCT04730765|Procedure|left elective colectomy (Surgical Experimental Group)|Conventional laparoscopic resection of the sigmoid colon is performed using four ports. The left colon is mobilised from the lateral side along Gerota's fascia. The splenic flexure is mobilised at the discretion of surgeons. The mesentery of the sigmoid colon is then medially fenestrated at the promontory level. The superior rectal artery as well as the inferior mesenteric artery and vein are identified and are cut using tissue-sealing devices. A linear stapler device is applied for division of the large intestine. The sigmoid is retracted through a Pfannenstiel incision or enlargement of the left lower abdominal incision. Colorectal anastomosis is performed using a double stapling technique following open resection of the affected colon.
15765692|NCT04730765|Drug|antibiotic therapy (medical Control Group)|Antibiotic treatement for 10 days by oral or intravenous administration
15765693|NCT04730752|Diagnostic Test|Appendicitis Inflammatory Response|A scoring system used to diagnose acute appendicitis. It consists of clinical findings and laboratory parameters
15765694|NCT04730752|Diagnostic Test|Adult Appendicitis Score|A scoring system used to diagnose acute appendicitis. It consists of clinical findings and laboratory parameters
15765695|NCT04730739|Device|FastFrame External Fixation System - Knee Spanning Kit or FastFrame External Fixation System - Damage Control Kit|The FastFrame External Fixation Systems - Knee Spanning Kit and Damage Control Kit are single-use external fixators that are sterile packed with all required components for convenience of the end user.
15765696|NCT04730726|Device|MSOT Acuity Echo|Hybrid optoacoustic and ultrasonography imaging
15765697|NCT04730713|Device|The morphology and parameters of cranial ultrasound spectrum based on cerebral artery|Subjects who meet the standards will undergo a full-body examination and basic life after entering the ICU Sign evaluation and monitoring, mainly including nervous system specialist physical examination, multi-modal brain function testing, Respiratory system monitoring and management, hemodynamic monitoring, APACHE Ⅱ score, GCS score, and routine general circulation, respiratory management, sedation and analgesia management, temperature management, infiltration Pressure management, lumbar pressure measurement The included subjects were monitored for optic nerve sheath diameter, TCD/TCCD before and after lumbar puncture, and recorded spectrum morphology: normal, high resistance state, ischemic topic, congestion state, spasticity, nail wave/oscillating wave state, S1S2 fusion high point state, and recording at the same time Parameters: systolic flow rate (Vs) Shu Tensile blood flow velocity (Vd), average blood flow velocity (Vm), pulsatility index (PI), impedance Index (RI)
15765698|NCT04730700|Procedure|Radiofrequency Ablation with MEE|RFA will be performed in the usual fashion utilizing the MEE instead of the RFA needles routinely used at each institution.
15765699|NCT04730700|Behavioral|Conventional Medical Management|Conventional medical management (CMM), which may include physical therapy, home exercise programs, pain medication, and other conservative therapies such as back brace, walking aid, and chiropractic care.
15765700|NCT04730687|Device|Traditional non surgical mechanical therapy|Mechanical instrumentation in all groups was made with titanium Gracey curettes (8mm in diameter, Langer ½, item code: 7103, Kohler Medizintechnik, GmbH & Co, Ltd, Stockach, Germany).
15765701|NCT04730687|Device|Diode laser assisted non-surgical mechancal therapy|One week after mechanical treatment, a 940 nm diode laser (Ezlase®, Biolase Technology, Inc., San Clemente, CA) with a 300 µm diameter optical fiber tip applied approximately 1 mm above the most apical part of the peri-implant pocket, parallel to the implant surface (E3-9 mm).
15765702|NCT04730687|Device|Er, Cr: YSGG laser-assisted non-surgical mechanical therapy|1 week after mechanical treatment, 2780 nm Er, Cr: YSGG laser (Waterlase®, Biolase Technology, Inc., San Clemente, CA), short pulse '' H '' with 500 µm diameter fiberoptic periodontal tip (RFPT5-14 mm) mode has been applied.
15765703|NCT04730674|Drug|tetracycline mixed with xylocaine|10 cc of saline containing 2 gm of tetracycline mixed with 5 ml of 2% xylocaine (as a pain relieving agent) was injected at the seroma bed.
15765704|NCT04730661|Diagnostic Test|Sit to stand test|"The sit to stand test (or STST) is a test consisting of performing as many sit-to-stand tests as possible in one minute, from a chair without armrests.
~We note before and during this test, the SpO2 (pulsed oxygen saturation) (rest value and minimum value during exercise), heart rate (HR), dyspnea on the modified Borg scale as well as the number of chair lifts performed. completely and minimum SpO2 during the recovery phase.
~The possible results from this one-minute test are as follows:
~If SpO2 <90% or appearance of signs of respiratory distress: Immediate stop of the test and hospitalization
~SpO2 <90% or decrease in SpO2 ≥ 4% during the test or during the recovery period: Hospitalization
~SpO2 ≥90% and no decrease in SpO2 ≥ 4% during the test or during the recovery period which will be 3 minutes maximum: discharge."
15765705|NCT04730648|Drug|PCSK9 inhibitor|For newly diagnosed ACS patients with diabetes, multivessel occlusion, or recurrent ACS attack, who are willing to accept PCSK9 inhibitor injection.
15765708|NCT04730622|Diagnostic Test|SARC-F questionnaire|Assessment of muscle performance based on self-reported information about grip strength, assistance with walking, rising from a chair, climbing stairs, and falls.
15765709|NCT04730622|Diagnostic Test|Bone tissue histology|Assessment of histomorphology and matrix-structure of tissue samples obtained from the bone resected during the hip prosthesis positioning.
15765710|NCT04730622|Diagnostic Test|Muscle tissue histology|Assessment of histomorphology and ultrastructure of muscle biopsies taken from the upper portion of the vastus lateralis muscle, which is accessed in the surgical procedure of hip replacement.
15765711|NCT04730622|Diagnostic Test|Myostatin serum levels|Quantification of circulating myostatin, a muscle-specific biomarker that suppresses muscle growth and bone formation.
15765712|NCT04730622|Diagnostic Test|Insulin-like growth factor 1 (IGF-1) serum levels|Quantification of circulating IGF-1, a growth factor that promotes muscle growth and osteogenesis.
15765713|NCT04730622|Other|Frequency food questionnaire|Assessment of dietary habits based on self-reported information about the monthly- weekly- or daily-frequency consumption of main food groups, including cereals and bread, meat, fish, fruit, vegetable, legumes, dairy products, sweets and snacks, drinks, and dietary supplements.
15765714|NCT04730622|Other|Gut microbiota profiling|Assessment of gut microbiome composition on stool samples.
15765718|NCT04730596|Drug|Normal saline|Normal saline in a labeled syringe
15765719|NCT04730583|Drug|Kybella|Injection into the cutaneous Neurofibromas lesion
15765720|NCT04730583|Device|980nm laser|Pulse laser at a wavelength of 980nm to the cutaneous Neurofibromas lesion
15765721|NCT04730583|Device|755nm Alexandrite Laser|Pulse laser at a wavelength of 755nm to the cutaneous Neurofibromas lesion
15765722|NCT04730583|Device|Radiofrequency|Using an insulated micro-needle, the radio-frequency will be delivered to the cutaneous Neurofibromas lesion
15765723|NCT04730570|Behavioral|Essential Coaching for Every Mother|Essential Coaching for Every Mother consists of 53 standardized text messages that provide evidence-based information that women should be aware of related to caring for their newborn and maternal mental health. Messages are personalized with the name of the child. Messages sent from birth to six-weeks postpartum, with two messages sent per day in the first two weeks and a daily message for weeks 3-6. The following topics covered in Essential Coaching for Every Mother include anxiety, depression, maternal self-care, postnatal follow-up, breastfeeding or formula feeding, infant concerns, cord care, well-baby care, normal development, crying, and safe sleep. Women who receive the messages will be able to self-select breastfeeding or formula feeding messages.
15765724|NCT04730557|Behavioral|Weight Loss|Each participant receives a calorie (kcal) prescription derived from calculations of estimated total energy expenditure (TEE) based on weight, height, sex, age, and activity level using equations developed by the Institute of Medicine [29]. Prescribed kcal levels are adjusted downward from the TEE to achieve a weekly weight loss of 1 to 2 pounds, generally a deficit of 500-1000 kcal/day. Weekly intervention sessions and activities will be delivered virtually using Microsoft Teams, Duke ZOOM or Duke Webex and led by Registered Dietitians.
15765725|NCT04730544|Drug|Nivolumab|480 mg
15765726|NCT04730544|Drug|Ipilimumab|1 mg/kg
15765727|NCT04730544|Drug|Nivolumab|induction phase : 240 mg and then maintenance : 480 mg
15765728|NCT04730531|Procedure|Local infiltration with 0.25% bupivacaine and epinephrine|The local infiltration will occur in 2 stages, separated by 30 minutes. The first dose will be injected just prior to the final tightening of set screws, decortication, and bone grafting, and will occur via multiple small volume injections 1 centimeter apart into the paraspinal musculature. The second injection will occur at an interval of 30 minutes following deep fascial closure and similarly consist of multiple small volume injections at 1 centimeter intervals into the subcutaneous tissue and skin.
15765729|NCT04730531|Procedure|Placebo of equal volume injectable saline|An equal volume of injectable saline will be used in the exact 2 stages as the treatment group. The first dose will be injected just prior to the final tightening of set screws, decortication, and bone grafting, and will occur via multiple small volume injections 1 centimeter apart into the paraspinal musculature. The second injection will occur at an interval of 30 minutes following deep fascial closure and similarly consist of multiple small volume injections at 1 centimeter intervals into the subcutaneous tissue and skin.
15765730|NCT04730518|Behavioral|Yoga-based group therapy|see above
15765731|NCT04730505|Device|MyHOPE™ for Multiple Myeloma|The MyHOPE for MM Platform is designed to provide patients with tools and resources to support them in their overall experience with MM. Patients can share their data through a PDF or by showing their device to their care team at clinic visits.
15765732|NCT04730505|Device|MyHope HCP Portal|Is designed to provide HCPs with the ability to view patient data and symptom notifications (Cohort 1 only) to provide support between clinic visits and to facilitate dialogue during clinic visits.
15765733|NCT04730466|Other|Neuropsychological rehabilitation|The intervention can be carried out in the research unit or in the Parkinson's association. Each session will consist of a series of cognitive stimulation tasks aimed at improving attention, perception and processing speed. These tasks will be applied through the NeuronUp cognitive neurorehabilitation platform to achieve maximum homogeneity and objectivity in their application. The program is programmed and is identical for all patients. Performing tasks through the platform allows us to objectively record the performance of each patient in all tasks.
15765734|NCT04730453|Procedure|ENB-guided ablation therapy combined with VATS|After receiving multidisciplinary assessments, Lesion A will receive ENB-guided ablation therapy and Lesion B will receive VATS at the same time.
15765735|NCT04730440|Other|AD-TAR|Intervention description: 12 sessions in groups of 4 subject, over 6 weeks (2 sessions per week), using a rehabilitation program named Training of Affect Recognition (TAR).
15765736|NCT04730440|Other|AD-Cognitive Stimulation|Intervention description: 12 sessions in groups of 4 subject, over 6 weeks (2 sessions per week), using classic cognitive stimulation workshops.
15765737|NCT04730427|Drug|GX-I7|Recombinant human interleukin-7 hybrid Fc
15765738|NCT04730427|Drug|GX-I7 vehicle|Formulation buffer of recombinant human interleukin-7 hybrid Fc
15765739|NCT04730414|Drug|Full-spectrum hemp (0.018% THC)|Topical Application
15765740|NCT04730401|Biological|Convalescent plasma from COVID-19 donors|Convalescent plasma from COVID-19 donors
15765741|NCT04730401|Biological|Placebo|200mL saline
15765742|NCT04730375|Drug|Dexmedetomidine Injection [Precedex]|two different doses dexmedetomidine bolus then maintenance infusion till end of surgeries and evaluation of lung mechanics and oxygenation
15765743|NCT04730362|Device|guedel airway|"Anesthesia will be conducted by induction with 1-2
~• Mg/kg of an IV propofol bolus and then anesthesia is maintained with an inhalational anesthesia with sevoflurane 2%-4%. The goal is to maintain the patient spontaneous ventilation throughout the procedure. Monitoring of the patients is done by MRI compatible pulse oximetry for heart rate and oxygen saturation which is connected to MRI control room."
15765744|NCT04730362|Device|supraglottic airway|supraglottic airway
15765745|NCT04730362|Drug|propofol bolus and then anesthesia sevoflurane|Mg/kg of an IV propofol bolus and then anesthesia is maintained with an inhalational anesthesia with sevoflurane 2%-4%
15765746|NCT04730349|Biological|Nivolumab|Specified dose on specified days
15765747|NCT04730349|Biological|NKTR-214|Specified dose on specified days
15765748|NCT04730336|Device|Tixel|Peri-Orbital fractional treatment on the Eye-Lid to assess the effect on Dry Eye symptoms
15765779|NCT04730063|Device|VQm PHM™|Procedure: Non-invasive measurements obtained with the VQm PHM™
15765780|NCT04730050|Drug|TT-01025-CL|Oral tablet
15765749|NCT04730323|Drug|Tocilizumab|"Participants received an initial dose calculated as per the body weight (8mg/kg) maximum 800mg/dose) over 1 hour, followed by up to three additional doses if required as per the response after the first dose with 8 hours intervals. Predefined Parameters of disease severity were assessed 12 to 24 hourly. Injection Paracetamol 1g was administered before infusion. The response of the participants after Tocilizumab administration was recorded based on clinical parameters (Oxygen requirement, Fever, Need for invasive positive pressure ventilation), biochemical parameters (D-dimers, C-reactive protein (CRP), Ferritin, Lactate dehydrogenase (LDH) levels), Chest X-ray findings, and Repeated PCR test for COVID-19. Any side effects noted after administration of TOCILIZUMAB were recorded.
~Any side effects noted after administration of TCZ/ Corticosteroid were recorded."
15765750|NCT04730310|Procedure|NSQIP Lower Extremity Open (LEO) procedure-targeted dataset (i.e. undergoing Lower extremity open revascularization) from 2014-2019|Infrainguinal, open lower extremity revascularization procedures
15765751|NCT04730297|Drug|paracetamol 500 mg plus codeine 30 mg preoperative administration|each patient 30 minutes before surgery received paracetamol 500 mg plus codeine 30 mg
15765752|NCT04730297|Drug|ibuprofen 400 mg preoperative administration|each patient 30 minutes before surgery received ibuprofen 400 mg
15765753|NCT04730297|Drug|Placebo oral tablet preoperative administration|each patient 30 minutes before surgery received placebo
15765754|NCT04730284|Other|Health supplements|tailor-made Synbiotics, 4g per day for 28 days
15765755|NCT04730271|Device|Total Knee Replacement|Subjects will be implanted with an ATTUNE Primary total knee replacement.
15765756|NCT04730258|Drug|CFI-400945|The starting dose is 32 mg/day for escalation arms and the recommended starting dose for the expansion arms.
15765757|NCT04730258|Drug|Azacitidine|Azacitidine will be given at its labeled dose and schedule
15765758|NCT04730258|Drug|Decitabine|Decitabine will be given at its labeled dose and schedule
15765759|NCT04730245|Drug|sodium phosphate enema, oral rifaximin and polyethylene glycol|Patients were hospitalized for 4-5 hours to receive two saline colon enemas with sodium phosphate Fleet®, 2 to 3 hours apart, appropriate hydration was provided during the procedure. If signs of fecal impaction were observed, the stools were removed manually prior to the first enema. Patients were discharged with oral treatment consistent with rifaximin 200 mg three times a day for 7 days and polyethylene glycol-3350, 17 gr per day in water for 10 days, but it was continued if necessary. Importantly, no modifications in time and dose of dopaminergic therapy or anti-dyskinetic medication (i.e. amantadine) were done at baseline or during the study
15765762|NCT04730219|Drug|Tislelizumab|Tislelizumab 200mg will be administered on Day 1 every 3 weeks for 3 cycles
15765763|NCT04730219|Drug|Nab paclitaxel|Nab paclitaxel 200mg will be administered on Day 2 every 3 weeks for 3 cycles
15765764|NCT04730206|Drug|Camostat|100 milligram tablets
15765765|NCT04730206|Drug|Placebo|oral tablets, identical in size and shape
15765766|NCT04730193|Drug|Caffeine|Caffeine, also known as Trimethylxanthine, will be purchased through the University of Oklahoma Health Sciences Pharmacy and formulated into capsule pills containing 100mg of active ingredient
15765767|NCT04730193|Drug|Placebo|Placebo pill will be formulated with a non active ingredient such as rice flour powder
15765768|NCT04730180|Device|Transcranial Magnetic Simulation|Brain stimulation treatment will be performed using FDA-cleared TMS coils according to their intended use of treatment of medication resistant depression by targeting the dorsolateral prefrontal cortex.
15765769|NCT04730180|Device|Mixed reality neuronavigation|Targeting of the dorsolateral prefrontal cortex will be performed with the help of a mixed reality neuronavigation system.
15765770|NCT04730167|Other|Neurological and neuropsychological assessments / MRI / PET scan / Video-oculography.|Essential data for this study are those collected during the concussion assessment, carried out as part of routine care at Princess Grace Hospital (medical background; history of sports practice and history of concussions; data extracted from clinical and neuropsychological evaluations, from imaging exams (MRI and PET-Scan) and from eye-tracking evaluation).
15765771|NCT04730154|Behavioral|Pain Neuroscience Education (PNE)|PNE is a cognitive behavioural intervention, including educating patients that pain is an output product of the brain resulting from input from multiple central and peripheral nervous system processes and leading to threat perception. Transferring that knowledge to patients, allows them to understand, accept and effectively cope with their pain. In order to obtain the targeted behavioural change, motivational interviewing is used as the communication process throughout PNE.
15765772|NCT04730154|Behavioral|Motivational Interviewing (MI)|Motivational interviewing is a directive, collaborative, patient-centered communication approach for eliciting and enhancing motivation for behaviour change by helping clients to resolve ambivalence and uncertainty.
15765773|NCT04730154|Behavioral|Biomedically-focused education|The traditional biomedical-focused education programme explains patient's pain experience from a tissue (injured versus healthy tissue) and biomechanical perspective.
15765774|NCT04730141|Other|Patient mobilization with pre-operative mobilization training and mobilization protocol|Postoperative mobilization for the first 24 hours
15765775|NCT04730102|Procedure|Rectal washout|Rectal washout is performed intraoperatively before transection and means irrigation of the rectum following the closure of the rectal lumen below the tumour with a purse string suture. Rectal washout is performed with a total of 500 ml sterile water. Fluid samples are collected after every 100 ml by instilling 50 ml of saline after each washout. A sixth sample is collected from the presacral cavity.
15765776|NCT04730089|Device|Electrical impedance tomography|A bolus of 10ml 10% NaCl was injected during a respiratory pause (≥10s) through the central venous catheter.The results of arterial blood gas analysis and the data of EIT were collected before the first prone session (time baseline), the end of prone positioning (time P).
15765849|NCT04729491|Drug|Nitazoxanide|500mg twice daily for 06 days
15765781|NCT04730037|Drug|Edoxaban|- Edoxaban 30 mg/60 mg tablet according to body weight. 60 kg or less: 30 mg once daily, over 60 kg: 60 mg once daily, reduced to 30 mg once daily depending on renal function and concomitant medications
15765782|NCT04730037|Drug|Warfarin Potassium|- Warfarin K 1 mg tablets once daily (Dose adjusted with target PT-INR of 1.5-2.5)
15765783|NCT04730037|Drug|Warfarin Potassium placebo|- Warfarin K 1 mg placebo tablets once daily
15765784|NCT04730037|Drug|Edoxaban placebo|- Edoxaban 30 mg/60 mg placebo tablet according to body weight. 60 kg or less: 30 mg once daily, over 60 kg: 60 mg once daily, reduced to 30 mg once daily depending on renal function and concomitant medications
15765785|NCT04730024|Other|Not applicable(observational study)|Not applicable(observational study)
15765786|NCT04730011|Behavioral|Short and Intensive Treatment|Intensive Treatment Week with behavioural psychotherapy
15765787|NCT04729998|Drug|Rivaroxaban film-coated tablet 20 mg|Rivaroxaban is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 20 mg of rivaroxaban.
15765788|NCT04729998|Drug|Xarelto® film-coated tablet 20 mg|Xarelto® is manufactured by Bayer AG, Germany. Each tablet contains 20 mg of rivaroxaban.
15765789|NCT04729985|Device|CGM device with diabetic education, CGM education and a follow up protocol.|Blind CGM placed and recorded for 14 days after discharge and data downloaded
15765790|NCT04729972|Combination Product|NT-501 CNTF implant|Single implantation of CNTF-secreting NT-501 device into one eye
15765795|NCT04729946|Device|Pure-Vu Cleansing Device|The Pure-Vu device attaches to the colonoscope and provides colonic cleansing during urgent colonoscopy without the need for a bowel preparation
15765796|NCT04729933|Device|V-Wave Shunt Placement|After the MitraClip Placement and after final screening, the existing transseptal puncture used for MitraClip placement is used to place the V-WAVE Shunt device.
15765797|NCT04729920|Device|Mechanical insufflation/exsufflation device (MI-E)|download of device (MI-E) data and self-reported satisfaction with the device
15765798|NCT04729907|Drug|Nusinersen|Administered as specified in the treatment arm
15765799|NCT04729894|Other|Medication Lockbox|Participants will receive a medication lockbox to store medications in their home.
15765800|NCT04729894|Behavioral|Education|Participants will receive information on safe medication storage practices.
15765801|NCT04729881|Other|Conventional Rehabiliation Group|Transcutaneous Electrical Nerve Stimulation, Ultrasound and Exercise
15765802|NCT04729881|Other|Spesific Exercise Group|Cervical stretching exercise, Craniocervical flexion exercise, Neck isometric exercises, Cervical retraction exercise, Scapular retraction exercise, Modified push-up plus exercise
15765803|NCT04729881|Other|Control group|No intervention will be aplied
15765804|NCT04729868|Drug|Levobupivacaine(chirocaine) plus dexmedetomidine(precedex)|evaluate the efficacy of levo-bupivacaine alone and with dexmedetomidine in Ultrasound guided infraclavicular brachial plexus block for hand and forearm surgeries
15765805|NCT04729855|Diagnostic Test|serum HOTTIP ,EIF4EBP1 and serum SNP HOTTIP rs1859168|5 ml fresh blood sample
15765806|NCT04729842|Procedure|Axillary Brachial plexus block|Brachial plexus block via axillary route was administered using 30 ml of 0.5% Bupivacaine in group B and 30 ml of 0.5% Ropivacaine in Group R
15765809|NCT04729816|Other|Controlled, high fat/low fiber diet background diet, sequentially supplemented with an escalating dose of a fiber-blend snack food.|"Phase 1: Participants will be provided with a high fat/low fiber diet in the form of packed out meals and snacks for 10 days in total (days 2-11 and days 54-63)
~Phase 2: Participants will be provided with the high fat/low fiber diet, plus 1 daily fiber-blend snack serving from days 12-25
~Phase 3: Participants will receive 2 daily fiber-blend snack servings to supplement the high fat/low-fiber diet from days 26-39.
~Phase 4: Participants will receive 3 daily fiber-blend snack servings to supplement the high fat/low-fiber diet from days 40-53.
~Phase 5: Participants will return to the unsupplemented high fat/low fiber diet for days 54-63"
15765810|NCT04729803|Behavioral|Experimental: Attention Guidance + Exposure|"Participants will receive a brief standardized psychoeducation module, presented via a video recording.
~Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes.
~Between speeches participants will have a 1-minute break.
~Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.
~The experimental attention guidance condition: (1) the intervention rationale will include information about the importance of visually attending to the faces of the audience; (2) participants will be given target audience members to focus their gaze on during the their impromptu response. They will be told that they should look at and focus on the target audience member for the whole response."
15765811|NCT04729803|Behavioral|Active Comparator: Exposure Alone|"Participants will receive a brief standardized psychoeducation module, presented via a video recording.
~Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes.
~Between speeches participants will have a 1-minute break.
~Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial."
15765850|NCT04729491|Drug|Placebo|Use of placebo q.d. for 30 days or until COVID-19 remission, in recently diagnosed COVID-19 subjects.
15765812|NCT04729803|Behavioral|Experimental: Attention Control + Exposure|"Participants will receive a brief standardized psychoeducation module, presented via a video recording.
~F
~Participants will then complete up to 10 analogue teleconferencing calls, each lasting a maximum of two minutes. During each call participants will be prompted by one of the audience members.
~Between speeches participants will have a 1-minute break.
~Participants will complete the subjective units of distress scale (SUDS) before and after each speech trial.
~The experimental attention control condition: (1) the intervention rationale will include information about the importance of attention control; (2) participants will be given target at the center of the screen to focus their gaze on during the their impromptu response. They will be told that they should look at and focus on the target for the whole response."
15765813|NCT04729790|Drug|PRIM-DJ2727|oral FMT capsules
15765814|NCT04729777|Procedure|Combined Cardiovascular Magnetic Resonance and Cardiopulmonary Exercise Testing|Clinical Cardiac MRI scan at rest with routine administration of gadolinium contrast agent. Participants then undergo the research component of the test which requires them to perform exercise, using a recumbent, MRI-compatible cycle ergometer, whilst their breathing is simultaneously analysed using a mask connected to a CPET machine, until they are limited by symptoms and they stop pedalling. Most participants will undergo only one scan. Some participants will be asked to have two or three such scans over 3 months to assess changes over time, and in response to standard treatment of pulmonary hypertension.
15765815|NCT04729764|Drug|GP681 Tablet|Designed as 5 dose groups (20mg, 40mg, 60mg, 80mg, 120mg), the starting dose group (20mg) 8 subjects (including 2 placebo), each other 10 subjects (including Placebo (2 cases), male and female.
15765817|NCT04729725|Biological|Anti-TGF-beta Monoclonal Antibody SAR-439459|Given IV
15765818|NCT04729725|Biological|Cemiplimab|Given IV
15765819|NCT04729712|Procedure|Anaesthesiologist-administered ultrasound guided Erector Spinae block with catheter insertion|Erector Spinae block: A bolus of 20 ml 0.375% Levobupivacaine will be administered into the erector spinae plane prior to surgical incision. A further bolus of 10 ml 0.25% Levobupivacaine will be given at skin closure if it has been greater than 1 hour after the first bolus of local anaesthetic medication. A continuous infusion of 0.125% Levobupivacaine will be commenced via the sited nerve catheter for postoperative analgesia. This will be started at 10 ml/hr and titrated to effect to a maximum rate of 15 ml/hr.
15765820|NCT04729712|Procedure|Surgeon-administered video-assisted Paravertebral block with catheter insertion|Paravertebral block: A bolus of 20 ml 0.375% Levobupivacaine will be administered into the paravertebral space after the thoracoscopic ports have been sited. A further bolus of 10 ml 0.25% Levobupivacaine will be given at skin closure if it has been greater than 1 hour after the first bolus of local anaesthetic medication. A continuous infusion of 0.125% Levobupivacaine will be commenced via the sited nerve catheter for postoperative analgesia. This will be started at 10 ml/hr and titrated to effect to a maximum rate of 15 ml/hr.
15765821|NCT04729699|Other|Aerobic exercise and exercise for TMJ|Aerobic exercise
15765822|NCT04729699|Other|Aerobic exercise at home|Aerobic exercise
15765823|NCT04729686|Other|Pericapsular Nerve Block|Per Standard Institutional Practice
15765824|NCT04729686|Other|Fascia Iliaca Nerve Block|Per Standard Institutional Practice
15765825|NCT04729673|Device|Digital caliper (Shenzhen Jiabaili Electronic Commerce Co., Ltd)|Measuring the vertical distance between the tip of the upper and the lower canine.
15765826|NCT04729660|Device|Kinesio Tex Gold|The Kinesio Tex Gold is a kinesio tape that had been certified and patented.
15765827|NCT04729647|Procedure|Mastectomy|Mastectomy for breast cancer Blood sample for Complete Blood Cell Count and other blood parameters (Delta Neutrophil Index, Immature Granulocyte Count)
15765828|NCT04729634|Other|Mobilization|Mobilization and breathing exercises according to clinical care
15765829|NCT04729621|Combination Product|TVB-009|TVB-009 Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
15765830|NCT04729621|Combination Product|Prolia®|Denosumab solution for injection 60 mg/mL (1 mL) prefilled syringe (PFS)
15765831|NCT04729608|Drug|AVB-S6-500|AVB-S6-500 is an experimental drug
15765832|NCT04729608|Drug|Paclitaxel|Paclitaxel is the standard of care, background therapy
15765833|NCT04729608|Other|Placebo|Matching placebo
15765834|NCT04729595|Drug|Tempol|Tempol 800 mg capsule will be administered at 400mg (2 capsules) two times daily for fourteen (14) consecutive days.
15765835|NCT04729595|Other|Placebo|Placebo capsules will be administered orally (2 capsules) two times daily for fourteen (14) consecutive days.
15765836|NCT04729582|Biological|Primary human muscle stem cells (Satori-01)|Primary human muscle stem cells are isolated from patient's muscle tissue and expanded ex-vivo. They are injected into the urethral sphincter region as a one-time autologous treatment.
15765837|NCT04729582|Other|Placebo|Placebo is the injection solution without muscle stem cells.
15765838|NCT04729569|Procedure|Feather edge finish line preparation|Tooth preparation with feather edge finish line will be done to posterior teeth to receive all ceramic full coverage zirconia crowns.
15765839|NCT04729569|Procedure|Deep chamfer finish line preparation|Tooth preparation with deep chamfer finish line will be done to posterior teeth to receive all ceramic full coverage zirconia crowns.
15765840|NCT04729556|Device|Sericin and chitosan cream|A novel film-forming cream containing sericin and chitosan
15765841|NCT04729543|Biological|Adoptive therapy with autologous MC2 TCR T cells|Adoptive therapy with autologous MC2 TCR T cells combined with AZA/VP
15765842|NCT04729530|Device|Dyson Pure Cool - Active Purifier|Free standing air purifier
15765843|NCT04729530|Device|Dyson Pure Cool - Placebo purifier|Placebo air purifier
15765844|NCT04729517|Drug|AI201901|Twice daily inhaled AI201901 for 4 weeks
15765845|NCT04729517|Drug|Azelastine Hydrochloride|Twice daily inhaled Azelastine Hydrochloride for 4 weeks
15765846|NCT04729504|Behavioral|Adapted Project BRAVE|A culturally and linguistically adapted Project BRAVE is web-based single session intervention that is about 30 minutes in length. The session is designed to focus on targeting child anxiety symptoms in the multilingual and diverse families in Miami-Dade.
15765847|NCT04729491|Drug|Dutasteride 0.5 mg|Use of dutasteride 0.5mg/day q.d. for 30 days or until COVID-19 remission, in recently diagnosed COVID-19 subjects.
15765848|NCT04729491|Drug|Azithromycin|Azithromycin 500mg/day for 05 days
15765851|NCT04729478|Device|Drug-induced sleep endoscopy|An intravenous bolus injection of midazolam 1.5 mg will be used to induce sleep. Maintenance of sedated sleep will be obtained by a target-controlled infusion of propofol (2.0-3.0 µg/mL).
15765852|NCT04729478|Device|Natural sleep endoscopy|Endoscopy during natural sleep.
15765853|NCT04729465|Drug|Propofol|Propofol
15765854|NCT04729465|Device|Bispectral Index Monitor|Bispectral Index Monitor
15765855|NCT04729452|Other|blood test|blood test to test immune response to SARS-CoV-2
15765858|NCT04729426|Other|Peanut Ball Position|The group of healthy pregnant women who meet the inclusion criteria will be determined by randomization according to the order of application to the delivery room. A group (intervention group) will be given positions using the peanut ball tool in active phase and transition phase and the positions will be changed every 30 minutes.
15765859|NCT04729413|Behavioral|Couples Counseling|Psychoeducational counseling on relationships and maternal and child health in the context of HIV.
15765860|NCT04729413|Other|Enhanced Standard of Care|Enhanced standard of care with education on pregnancy and postpartum health, similar to what is presented to women at routine antenatal and postpartum care.
15765861|NCT04729400|Device|Vacuum Myofascial Therapy device|Therapeutic Percutaneous Electrolysis and Vacuum Myofascial Therapy device once week for four weeks associated with eccentric exercises devices at home.
15765862|NCT04729400|Other|physical therapy program|The multimodal physical therapy program includes 10 sessions of ultrasound pulsatil therapy (US) and massage associated with eccentric exercises devices at home.
15765863|NCT04729400|Procedure|Therapeutic Percutaneous Electrolysis|Therapeutic Percutaneous Electrolysis
15765864|NCT04729400|Procedure|ultrasound pulsatil therapy (US) and massage|ultrasound pulsatil therapy (US) and massage
15765865|NCT04729387|Drug|Alpelisib|Alpelisib will be administered at 200 mg orally once daily following food on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28-day cycle
15765866|NCT04729387|Drug|Olaparib|Olaparib will be administered at 200 mg orally twice daily irrespective of meals on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28-day cycle.
15765867|NCT04729387|Drug|Paclitaxel|Paclitaxel will be administered at 80 mg/m2 as an intravenous infusion weekly during a 28-day treatment cycle, starting on Cycle 1 Day 1, and on Day 8, Day 15 and Day 22 of every cycle thereafter
15765868|NCT04729387|Drug|Pegylated liposomal doxorubicin (PLD)|PLD will be administered at 40-50 mg/m2 (physician discretion) as an intravenous infusion once every 28-days in a 28 day treatment cycle, starting on Cycle 1 Day 1
15765869|NCT04729361|Genetic|CGH array analysis|CGH array analysis
15765870|NCT04729348|Drug|Pembrolizumab|Oral, daily, dosage per protocol
15765871|NCT04729348|Drug|Lenvatinib|Oral, daily, dosage per protocol
15765872|NCT04729335|Diagnostic Test|phonocardiac spectrometry|Detection and application of organic disease with phonocardiac spectrometry
15765873|NCT04729322|Procedure|Biopsy|Undergo biopsy
15765874|NCT04729322|Procedure|Fecal Microbiota Transplantation|Undergo colonoscopic FMT
15765875|NCT04729322|Drug|Fecal Microbiota Transplantation Capsule|Given PO
15765876|NCT04729322|Drug|Metronidazole|Given PO
15765877|NCT04729322|Drug|Neomycin|Given PO
15765878|NCT04729322|Biological|Nivolumab|Given IV
15765879|NCT04729322|Biological|Pembrolizumab|Given IV
15765880|NCT04729322|Other|Questionnaire Administration|Ancillary studies
15765881|NCT04729322|Drug|Vancomycin|Given PO
15765882|NCT04729309|Drug|[12C] RO7049389|Participants will receive oral [12C] RO7049389.
15765883|NCT04729309|Drug|[13C] RO7049389|Participants will receive IV [13C] RO7049389.
15765884|NCT04729309|Drug|[14C] RO7049389|Participants will receive an oral suspension of [14C] RO7049389.
15765885|NCT04729296|Drug|Golimumab|For participants ≥45 kg, 50 mg of golimumab will be administered subcutaneously For participants <45 kg, the dose of golimumab is 30 mg/m2 to maximum of 50 mg
15765886|NCT04729296|Drug|Placebo|Inactive Drug
15765887|NCT04729283|Procedure|Sigmoidectomy|The sigmoid resection surgery, realized by laparoscopy or laparotomy, with anastomosis.
15765888|NCT04729270|Procedure|Physiotherapy treatment with physium device.|The intervention for this group consisted of 10 sessions with Transcranial Direct Current Stimulation for a month.
15765889|NCT04729270|Procedure|Conventional physiotherapy treatment.|The intervention for this group consisted of 10 sessions with Electrical Nerve Stimulation (TENS) for a month.
15765890|NCT04729257|Device|Philips IntelliSpace Cognition (ISC).|Philips ISC is a Class-II Medical Device in the US that aids in assessing cognition and helps inform the HealthCare Professional (HCP) to make a diagnosis and treatment plan. ISC can be used in a variety of healthcare environments such as neurology and neuropsychology practices.
15765891|NCT04729257|Diagnostic Test|Paper-Pencil Tests.|The same cognitive tests that are on the ISC platform are performed using paper and pencil (rather than digitally) as is the case in standard clinical practice.
15765892|NCT04729244|Drug|CBD|Hemp Oil
15765893|NCT04729231|Procedure|Nasalis Sling Flap|The nasalis sling flap involves alteration of the nasalis muscle to create a myocutaneous pedicle flap that will be used to fill in the wound.
15765894|NCT04729231|Procedure|Lobed Transposition Flap|Lobed flap reconstruction involves the use of cutaneous tissue located adjacent to the nasal tip to fill in the wound. The flap will undergo a 90-degree arc to approximate the desired position.
15765895|NCT04729218|Behavioral|movement imagery ability|Determining the movement imagery ability: internal visual, external visual and kinesthetic imagery
15765926|NCT04728932|Drug|Levosimendan|A continuous infusion of Levosimendan over 24h
15765927|NCT04728932|Drug|Placebo of Levosimendan|A continuous infusion of Placebo of Levosimendan over 24h
15766004|NCT04728282|Procedure|RTSA with subscapularis repair|Lateralized reverse total shoulder arthroplasty with repair of subscapularis
15765896|NCT04729205|Drug|Promitil|The first 6 patients recruited to the study will receive 1.6 mg/kg Promitil. Dose escalation to cohort 2 (PROMITIL dose of 2mg/kg) will be authorized after 5 or 6 patients of cohort 1 have completed the second cycle with DLT detected in fewer than two patients. If ≥2 patients of Cohort 1 develop DLT, dose escalation will be halted and Cohort -1 (PROMITIL dose of 1.2 mg/kg) will be opened. Should ≥2 patients in Cohort -1 or Cohort 2 experience DLT events, the study will be discontinued. In parallel, on days 1 and 15 of each cycle, patients will be treated with the mFOLFOX6 regime, which involves concurrent treatment with oxaliplatin 85 mg/m2 IV and leucovorin 200 mg/m2 IV, immediately followed by 5-FU 400 mg/m2 IV bolus, and then continuous infusion of 5-FU 1200 mg/m2/day, for 2 days (46-48 h).
15765897|NCT04729192|Other|ObsQoR-10T Questionnaire|The ObsQoR-10T questionnaire consists of 10 items assessing physical comfort and pain, physical independence, and emotional status. Each item is scored from 0 to 10 and the total score is the sum of the score for each item, which is a score from 0 to 110.
15765898|NCT04729179|Drug|Cannabidiol|Participants will start with 10 mg of cannabidiol daily and the dose will be escalated every third day until the maximum dosage of 50 mg is reached (after two weeks). The participants be on the 50 mg dosage of cannabidiol for 24 weeks.
15765899|NCT04729179|Drug|Placebo|Placebo is administered as tablets of 10 mg that are identical in appearance, taste, and smell to the Cannabidiol tablets.The participants will be on the 50 mg dosage of placebo for 24 weeks.
15765900|NCT04729166|Behavioral|Structured education and follow-up|This structured educational material was developed by the authors on the basis of the literature. Interventions of the study were carried out in the 32nd-42nd week of pregnancy, 3rd-7th day postpartum, and at the 1st month. At first stage, a 15-20-minute education was given to the pregnant women in the study group in the breastfeeding room of the facility, educational booklets were distributed. The main emphasis parts of the education were repeated with a standard summary information form at each follow-up.
15765901|NCT04729153|Drug|DAAD Compound|Sofosbuvir , Daclatasvir and ribavirin
15765902|NCT04729140|Drug|Ivermectin Tablets|Double-blinded, prospective, placebo controlled outpatient randomized clinical trial.
15765903|NCT04729140|Drug|Doxycycline Tablets|Double-blinded, prospective, placebo controlled outpatient randomized clinical trial.
15765904|NCT04729140|Drug|Placebo|Double-blinded, prospective, placebo controlled outpatient randomized clinical trial.
15765905|NCT04729127|Behavioral|Project ImPACT|Project ImPACT (Improving Parents As Communication Teachers) is an evidence-based parent-mediated intervention program based on best practices in early intervention. The program is designed for young children up to age six with social communication delays, including autism spectrum disorder. Project ImPACT focuses on social engagement, language, social imitation, and play. Project ImPACT is a naturalistic developmental behavioral intervention (NDBI).
15765906|NCT04729114|Drug|abiraterone decanoate|"PRL-02 depot (abiraterone decanoate for intramuscular injection) is a solution formulation of abiraterone decanoate at a concentration of 180 mg/mL and will be provided as a 10 mL vial containing 990 mg of abiraterone decanoate in 5.5 mL of solution.
~PRL-02 will be administered as an intramuscular injection every 84 days (+3 days)"
15765907|NCT04729101|Drug|Vonoprazan|Oral tablet
15765908|NCT04729101|Drug|Lansoprazole|Oral capsule
15765909|NCT04729088|Drug|Isosorbide mononitrate|Intra-anal application performed by the study physician of 2 g of the study drug
15765910|NCT04729075|Other|ARDS and COVID19 treatments|Interventions that will be analyzed will include: immunomodulation; oxygen supplementation type, duration and level; mechanical ventilation type, duration; diuresis; inotrope/vasopressors; prone positioning
15765911|NCT04729062|Drug|Pegcetacoplan|Complement (C3) Inhibitor
15765912|NCT04729049|Procedure|Erector Spinae plane Block|Ultrasound-guided interfascial technique, aiming to block the anterior and posterior branches of the spinal nerves for multi-dermatomal analgesia. Injection of local anesthetic in the plane deep to the erector spinae muscles and superficial to the transverse processes, to achieve a craniocaudal distribution along several vertebral levels.
15765913|NCT04729049|Drug|Patient controlled analgesia with intravenous morphine|Patient-controlled intermittent boluses of morphine 1 mg (maximum once every 15 minutes).
15765914|NCT04729036|Procedure|open reduction and internal fixation|The same surgical team have treated all the patients through open reduction via an intra-oral mucosal flap under general anesthesia with insertion and fixation of a 4-6 holes 2.0 miniplate and 5 mm screws at the superior border of the mandible at Champy's osteosynthesis line
15765915|NCT04729023|Procedure|Pars plana vitrectomy combined with cataract surgery.|In the combined surgery group, phakic diabetes retinopathy patients over 45 years old without severe lens opacity will receive pars plana vitrectomy combined with phacoemulsification and intraocular lens (IOL) implantation at the same time.
15765916|NCT04729023|Procedure|Pars plana vitrectomy with subsequent cataract surgery.|In the control group, phakic diabetes retinopathy patients over 45 years old without severe lens opacity will first receive pars plana vitrectomy and a subsequent phacoemulsification with IOL implantation will be performed at least 6 month after the PPV.
15765917|NCT04729010|Other|Acupuncture to treat anxiety in Parkinson disease|Subjects will be randomized in a 1:1 ratio to receive sham acupuncture.
15765918|NCT04728984|Drug|Nalfurafine Hydrochloride|"Nalfurafine Hydrochloride 2.5μg*2
~; Oral administration after dinner, once daily for 14 consecutive days"
15765919|NCT04728984|Drug|Nalfurafine Hydrochloride+Placebo|Nalfurafine Hydrochloride 2.5μg+ A placebo pill; Oral administration after dinner, once daily for 14 consecutive days
15765920|NCT04728984|Drug|Placebo|two placebo pills; Oral administration after dinner, once daily for 14 consecutive days
15765921|NCT04728971|Drug|Micafungin Sodium 50 MG Injection|Give Micafungin 150 mg/d within 24 hours after liver transplantation.
15765922|NCT04728971|Drug|Caspofungin Acetate|Give Caspofungin 35 mg/d lasts 1 week after liver transplantation.
15765923|NCT04728958|Behavioral|Gratitude|A positive psychology intervention using expressions of gratitude
15765924|NCT04728945|Procedure|lung recruitment|Automatic lung recruitment using the anesthetic machines (with PEEP 15 cmH2O for 30 seconds) will be performed every 30 minutes during laparoscopy.
15765925|NCT04728945|Procedure|Standard ventilatory management|"After tracheal intubation, standard ventilatory management (metered ventilation) should be performed with the following initial settings, and rescue should be performed when hypoxemia occurs, if necessary.
~[initial setting] PEEP 4cmH2O, FIO2 0.3 Ventilation rate: 6-8 ml/kg predicted body weight (PBW)"
15765928|NCT04728906|Device|Heart patch seeded with autologous cardiomyocytes and amnion epithelial stem cells|heart patch is seeded with patient's cardiomyocytes (taken from patient's heart waste tissue when undergoing bypass surgery) and stock amnion epithelial stem cells (HLA-DR negative to eliminate risk of rejection)
15765929|NCT04728893|Drug|Nemtabrutinib|Nemtabrutinib tablets administered PO QD.
15765930|NCT04728880|Drug|Remdesivir|This study is a retrospective trial to assess the efficacy of Remdesivir in adult patients diagnosed with COVID-19 in Mansoura University Isolation Hospital. In this study we will analyze the data collected during treatment.
15765931|NCT04728867|Other|to compare the educational effectiveness of various educational tools|This prospective, randomized, blinded study is designed to compare the educational effectiveness of various educational tools including the surgical textbook, animation, and cadaveric videos in laparoscopic rectal surgery among board-certificated surgeons.
15765932|NCT04728841|Genetic|Injection of GS001|"Patients will be enrolled sequentially every 3 weeks or more between cohorts. Dose escalation may occur after a single patient has been safely dosed if the resulting FVIII activity at Week 3 is < 5 IU/dL.The dose levels are as follows:
~2×10^12 vg/kg
~6×10^12vg/kg
~2×10^13 vg/kg"
15765933|NCT04728828|Biological|Serological COVID-19 vaccine immunogenicity|Serological test
15765934|NCT04728815|Behavioral|TAU - Phase 1|4-8 weeks of TAU treatment
15765935|NCT04728815|Behavioral|CAMS - Phase 1|4-8 weeks of CAMS treatment
15765936|NCT04728815|Behavioral|DBT - Phase 1 and 2|up to 16 weeks of DBT treatment
15765937|NCT04728815|Behavioral|CAMS - Phase 2|Up to 8 weeks of CAMS treatment
15765938|NCT04728815|Behavioral|DBT - Phase 2|Up to 8 weeks of DBT treatment
15765939|NCT04728802|Drug|Proxalutamide|Proxalutamide 300mg q.d
15765940|NCT04728802|Drug|Placebo|Placebo pill
15765941|NCT04728789|Drug|Avatrombopag 20 MG|Avatrombopag 20mg/week to 60mg/day, starting at 20mg/day and increased by 20 mg/day every 2 weeks if the platelet count remains less than 20×10e9/L and reduced if the platelet count reaches over than 150×10e9/L.
15765942|NCT04728763|Other|Protein profile|Analysis of the protein content by proteomics of bronchoalveolar lavage
15765943|NCT04728750|Procedure|Enucleation of a tumor of the pancreas|Enucleation of a tumor in the pancreas is feasible and safe, as it offers a minimally invasive approach, and morbidities are fewer than open or conventional approach
15765944|NCT04728737|Other|swallowing therapy|oral exercises, tongue movement, and compensatory techniques, swallowing maneuvers and food modifications, will be performed by an experienced speech and language therapist during intervention
15765945|NCT04728737|Other|IOPI therapy|tongue muscle strengthening and endurance exercises by using 15-min IOPI biofeedback program. The biofeedback will be 50%-60% of maximal strength. (total 1 hour/session for 10 sessions)
15765946|NCT04728737|Other|neuromuscular electrical stimulation (NMES) therapy|"The neuromuscular electrical stimulation (NMES) therapy with VitalStim therapeutic device will be done by one physician who is licensed practitioner and certified in use of the VitalStim device. The placement of 2-channel electrodes is depended on the dysphagic types and the clinical swallowing disorders with for oropharyngeal muscles
~(1 hour/session for 10 sessions)"
15765947|NCT04728724|Drug|Sintilimab|"Neoadjuvant treatment stage: Sintilimab 200mg, q3w, i.v., 2-4 cycles, then receive chest CT evaluation.
~Surgery stage: the patients will receive radical surgery after the neoadjuvant treatment.
~Adjuvant treatment stage: according to the NCCN guidelines."
15765948|NCT04728724|Drug|Chemotherapy|"Neoadjuvant treatment stage: Sintilimab 200mg, q3w, i.v., 2-4 cycles; platinum-based chemotherapy (Non-squamus: Carboplatin AUC 5 + Pemetrexed 500mg/m2; Squamous: Carboplatin AUC 5 + Gemcitabine 1000mg/m2 or Paclitaxel 200mg/m2) q3w, i.v., 2-4 cycles, then receive chest CT evaluation.
~Surgery stage: the patients will receive radical surgery after the neoadjuvant treatment.
~Adjuvant treatment stage: according to the NCCN guidelines."
15765949|NCT04728711|Drug|ADX-629|ADX-629, 600 mg administered orally twice daily (PO bid) for a minimum of 1 week
15765950|NCT04728711|Drug|Placebo|Placebo, 600 mg administered orally twice daily (PO bid) for minimum 1 week
15765951|NCT04728698|Drug|COVI-MSC|1 x 10^6 MSCs/kg or 1.5 x 10^6 MSCs/kg, depending on CRP level
15765952|NCT04728698|Drug|Placebo|Equivalent volume of placebo will be administered
15765953|NCT04728685|Procedure|Mechanical Traction|Mechanical Traction will be applied to the lumbar region using a traction unit.
15765954|NCT04728672|Other|Kinesio Tape|Kinesio Tape
15765955|NCT04728672|Other|Micropore Tape|Micropore Tape
15765956|NCT04728659|Drug|Desogestrel 0.075 MG|It will be given orally for 3 to 5 days during FSH administration for ovarian stimulation
15765957|NCT04728659|Drug|Orgalutran|It will be given subcutaneously for 3 to 5 days during FSH administration for ovarian stimulation
15765958|NCT04728646|Drug|DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg, for intracanalicular use|Inserted During Screening/Baseline: Day Zero in either the right or left eye (depending on randomization)
15765959|NCT04728646|Device|Regular dissolvable intracanalicular plug|Inserted During Screening/Baseline: Day Zero in either the right or left eye (depending on randomization)
15765964|NCT04728620|Other|Diabetes Care Gaps Patient Portal Intervention|The Diabetes Care Gaps Patient Portal Intervention involves a new feature embedded with the My Health At Vanderbilt (MHAV) native app (on Epic's MyChart platform) for mobile devices that allows patients to: (a) receive notifications when the patient is due for certain types of diabetes monitoring and preventative care and (b) initiate an order for the care. Automated notifications will be sent to patients if, according to the evidence-based guidelines, the patients are due for a hemoglobin A1C blood test, microalbumin urine test, diabetes eye exam, or pneumonia vaccination. Once notified patients can initiate orders for the care within the MHAV app. The patient will receive confirmation when the order has been processed and will be provided instructions to receive the relevant care.
15766002|NCT04728308|Drug|Bupivacain|Before closing the skin incision,Infiltration of 20ml of 0.5% bupivacaine around incision site will be done in the patients of experimental group and 20 ml of distill water will be infiltrated in the pateints of the placebo group
15765965|NCT04728607|Device|Compression device.|A compression device is a device that uses circumferential compression to reduce swelling around a stuck ring. The device is used by placing it near, but not overtop, the offending ring, and then is inflated compressing the finger. The device is applied, and the hand elevated, for approximately five minutes. The device is then removed, and with a small amount of lubricant, the ring is removed.
15765966|NCT04728594|Behavioral|Social Proof|Email
15765967|NCT04728594|Behavioral|Reframing|Email
15765968|NCT04728594|Behavioral|Scarcity Message|Email
15765969|NCT04728581|Drug|Mirtazapine|Use of 3.75mg mirtazapine before lights-out during first 2 weeks after TKA surgery. With insufficient effect on sleep, patients are allowed to increase medication to 7.5mg mirtazapine.
15765970|NCT04728581|Drug|Quetiapine|Use of 3.125mg quetiapine before lights-out during first 2 weeks after TKA surgery. With insufficient effect on sleep, patients are allowed to increase medication to 6.25mg mirtazapine.
15765971|NCT04728581|Drug|Placebo|a gelatinous capsule without an active ingredient
15765972|NCT04728568|Drug|Sintilimab|Sintilimab binds to PD-1, an inhibitory signaling receptor expressed on the surface of activated T cells, and blocks the binding to and activation of PD-1 by its ligands, which results in the activation of T-cell-mediated immune responses against tumor cells
15765973|NCT04728555|Procedure|Game about radiotherapy|A digital pedagogical game about radiotherapy
15765974|NCT04728542|Device|ORIGIN PS System|Group of 70 subjects who will undergo a surgery with the ORIGIN PS System
15765975|NCT04728542|Device|VANGUARD PS System|Group of 70 subjects who will undergo a surgery with the VANGUARD System
15765976|NCT04728529|Procedure|USSM protocol|"In the initial step, all subjects will receive emergency management: oxygen support, vascular access, and fluid therapy. Doppler ultrasonography by Ultrasound Cardiac Output Monitoring (USCOM) is also performed to record initial stroke volume (SV), cardiac index (CI), and systemic vascular resistance (SVR). The initial fluid resuscitation is 20 mL/kg body weight, then the response measured by clinical and USCOM examination. If any improvement of clinical sign and normal SVI, CI, SVR, intervention will be stopped. In contrary, if shock persist, subsequent fluid resuscitation and/or vasoactive therapy will be administered, guided by USCOM.
~The therapeutic goal of USCOM: SVI 30-60 mL/m2, CI 3.3-6.0 L/minute/m2, and SVRI 800-1600 d.s/cm5/m2"
15765977|NCT04728529|Procedure|ACCM protocol|In the initial step, all subjects will receive emergency management: oxygen support, vascular access, and fluid therapy. Doppler ultrasonography by Ultrasound Cardiac Output Monitoring (USCOM) is also performed to record initial stroke volume (SV), cardiac index (CI), and systemic vascular resistance (SVR). The initial fluid resuscitation is 20 mL/kg body weight, then the response measured by clinical. If any improvement of clinical sign, intervention will be stopped. In contrary, if shock persist, subsequent fluid resuscitation and/or vasoactive therapy will be administered, guided by clinical parameter.
15765978|NCT04728516|Drug|Vonoprazan-based dual eradication therapy for two weeks|Patients with ACS after PCI, associated with positive Hp need a long-term DAPT treatment. We conducted a study on the prevention of gastrointestinal bleeding between vonoprazan-based dual eradication therapy for two weeks and pantoprazole for six months of a rountine therapy.
15765979|NCT04728516|Drug|amoxicillin|amoxicillin
15765980|NCT04728516|Drug|Pantoprazole|Pantoprazole
15765981|NCT04728503|Behavioral|5-Minute Mindful Movement Video|5 minute video includes a brief verbal introduction to mindfulness and then guides participants through a mindful movement exercise to facilitate grounding in the present moment and activation of the parasympathetic nervous system.
15765982|NCT04728503|Behavioral|Written Educative Materials|1 page written educative material about the benefits of mindfulness to serve as a control.
15765983|NCT04728490|Other|Allogenic transplantation transplantation|Haplo-identical transplantation with the use of Treosulfan, Thiotepa and Fludarabine in conditioning regimen.
15765984|NCT04728477|Device|OPti BP measurements|measurement of blood pressure with the new smartphone App ( OPTIBP)
15765985|NCT04728464|Procedure|Periodontally Accelerated Osteogenic Orthodontics (PAOO)|Fixed appliance will be placed for every patient, then surgical procedure will be applied after reflecting a full-thickness labial flap.
15765986|NCT04728451|Behavioral|Spectacle wear support|Parents of children in the full-time group are provided with encouragement, support, and counseling throughout the study in order to maximize their child's spectacle wear.
15765987|NCT04728451|Device|Spectacles|Children prescribed and provided spectacles with full correction of their refractive error, with the exception of prescriptions with ≥ +1.50D sphere (plus cylinder notation) in the least hyperopic eye, which will be symmetrically reduced by 1.00D
15765988|NCT04728425|Drug|subcutaneous immunoglobulin (SCIG)|20% subcutaneous immunoglobulin
15765989|NCT04728425|Drug|intravenous immunoglobulin + subcutaneous immunoglobulin (SCIG)|10% intravenous immunoglobulin + 20% subcutaneous immunoglobulin
15765990|NCT04728412|Device|High Flow Oxygen Therapy (HFOT)|HFOT administration in patients undergoing bronchoscopy under moderate sedation, affected by or at risk of hypoxemic and/or hypercapnic respiratory failure.
15765991|NCT04728399|Dietary Supplement|Experimental group|Take 1 bag a day with warm boiling water. Intervention: 2g Soybean peptide, 3g CLA and ng protein. They will complete all baseline, 12-weeks, and 24-weeks visits
15765992|NCT04728399|Dietary Supplement|Control group|Take 1 bag a day with warm boiling water. Intervention: 2g+N protein and 3g Soybean oil. They will complete all baseline, 12-weeks, and 24-weeks visits
15765993|NCT04728386|Other|curcumin solution|2 % curcumin solution as root canal irrigant
15765994|NCT04728386|Other|sodium hypochlorite|2.5% sodium hypochlorite solution as root canal irrigant
15765995|NCT04728373|Procedure|surgery|the need for surgery after aircraft accidents
15765996|NCT04728360|Drug|BAT2206|45 mg/0.5 mL
15765997|NCT04728360|Drug|Stelara (EU-sourced)|45 mg/0.5 mL
15765998|NCT04728347|Biological|ARCT-021|ARCT-021 single dose
15765999|NCT04728334|Drug|AK117|An intravenous (IV) infusion of AK117 as monotherapy. All subjects will receive 4 weekly infusions (Days 1, 8, 15, and 22) of AK117 in each 28-day treatment cycle until unacceptable toxicity, documentation of confirmed progressive disease (PD), or subject withdrawal
15766000|NCT04728321|Biological|AK104 lenvatinib|Subjects will receive AK104 and lenvatinib until disease progression or for a maximum of 24 months
15766001|NCT04728321|Biological|AK104|Subjects will receive AK104 until disease progression or for a maximum of 24 months
15766005|NCT04728282|Procedure|RTSA without subscapularis repair|Lateralized reverse total shoulder arthroplasty without repair of subscapularis
15766006|NCT04728269|Other|Lactibiane Topic AD|Application of Lactibiane topic AD twice a day (morning and evening) on one lesional area
15766007|NCT04728269|Other|Placebo|Application of placebo twice a day (morning and evening) on the symmetrical lesional area
15766008|NCT04728256|Behavioral|Laughter therapy+Music listening+Keeping diary|"Laughter therapy was carried out by the researcher as a total of three sessions every 15 days, and each session lasted 30 minutes.
~Participants listened to the types of music that they like (pop, Turkish folk music). In the meeting room in FHC, Two professional artists performed music recitals with a guitar and saz (qopuz) to pregnant women, and pregnant women actively participated in this process. The performance was carried out as three sessions, once every 15 days, and each session took 40 minutes.
~In addition to music listening and laughter therapy, the pregnant women were asked to keep a diary to write down their emotions about their health status, pregnancy and baby. Then, each participant had an opportunity to explain her emotions or replies to the questions during the group therapy sessions every 15 days so that pregnant women were able to express their feelings."
15766009|NCT04728243|Other|WHO QualityRights e-training|The WHO QualityRights online training aims to increase knowledge about the rights of people with psychosocial disabilities and change negative attitudes towards these persons and their role as rights holders. Furthermore, the training provides mental health professionals with the skills necessary to support people with psychosocial disabilities to advocate for their rights. The WHO QualityRights online training includes five core modules: 1) Human rights; 2) Mental health, disability, and human rights; 3) The right to health and recovery; 4) Legal capacity and the right to decide; 5) Free from coercion, violence, and abuse. Each module is composed of presentations, videos, interactive exercises, and forum discussions involving all participants. In the online training forum discussions, particular attention will be given to issues relevant to the Ghanaian context.
15766010|NCT04728243|Other|WHO COVID-19 online training|The WHO novel coronavirus 2019 online training series provides a general introduction to COVID-19 and similar respiratory infections and information on what facilities and professionals should be doing to prevent and respond to COVID-19 cases. The training is similar in length to the WHO QualityRights training (13 h 15 min vs. 19 hours) and is intended for health professionals and other stakeholders.
15766011|NCT04728230|Drug|Carboplatin|Given IV
15766012|NCT04728230|Biological|Durvalumab|Given IV
15766013|NCT04728230|Drug|Etoposide|Given IV
15766014|NCT04728230|Drug|Olaparib|Given PO
15766015|NCT04728230|Radiation|Radiation Therapy|Undergo consolidative thoracic radiation therapy
15766016|NCT04728217|Drug|Efmoroctocog Alfa Injection [Eloctate]|Efmoroctocog alfa should be administered according to Summary of Product Characteristics (SmPC)/ Instruction on Medical Use approved by Russian Ministry of Health ЛП-006034 (13.01.2020).
15766017|NCT04728204|Behavioral|Depresijos terapija|Intervention is based on the principles of cognitive behavioral therapy and culturally adapted to elderly Lithuanian population. The main purpose of the intervention is to reduce the symptoms of depression and increase psychological well-being. Intervention contains psychoeducation, examples, exercises and consultation with a psychologist.
15766018|NCT04728191|Other|Physiotherapy|physiotherapeutical instructions and training as described.
15766019|NCT04728191|Other|standard care|Standard care as described.
15766020|NCT04728178|Other|Crystalloid solution|Crystalloid solution is a true solution and is able to pass through a semipermeable membrane.
15766021|NCT04728178|Other|Colloid solution|Colloid solution is a heterogeneous mixture whose particle size is intermediate between those of a solution and a suspension.
15766022|NCT04728152|Other|Blood and salivar test|"Saliva samples will be taken (concomitant with a visit carried out as part of routine care):
~At the pre-therapy visit (t3),
~At the post-treatment visit (at 3-6 weeks).
~Blood samples will be taken at two stages (concomitant with a blood test performed as part of routine care):
~At the pre-therapy visit (t3),
~At the post-treatment visit (at 3-6 weeks)."
15766023|NCT04728139|Diagnostic Test|glypican 3|Assessment of glypican 3 presence in colorectal cancer patients using ELISA
15766024|NCT04728126|Other|Survey|"The questionnaire will include socio-demographic information (i.e., gender, age, job seniority) and sub-scales for measuring study variables (i.e., menopausal symptoms, social and personal resources, burnout, and work ability).
~Menopausal symptoms will be assessed using the Menopause-Specific Quality of Life questionnaire.
~Job burnout will be measured through OBI inventory, which consists of 16 items describing the states of emotional exhaustion and detachment - two core dimension of burnout, and were developed to meet different occupational groups.
~The menopause and the quality of working environment will be assessed using the Questionnaire developed by National Health Service in England and Wales."
15766025|NCT04728113|Other|Supportive care visit with questionnaires|5 Questionnaires (SCNS, QLQ-C30, HADS, PTPQ, GSE) will be filled by the patient with introduction of supportive care visit
15766026|NCT04728113|Other|Oncological standard visit|Oncological standard visit
15766027|NCT04728100|Other|LQT|Patients with LQT syndrome diagnosis.
15766028|NCT04728087|Device|ACCEL® Absorbable Hemostat Powder|Up to 2 bellows (10 grams nominal) of ACCEL®
15766029|NCT04728087|Device|Gelfoam® (Absorbable Gelatin Sponge, Pfizer Manufacturer Part Number 0342-01)|Up to 12.5 cm x 8.0 cm of Gelfoam®
15766030|NCT04728074|Other|The Entering Employment and Sustaining Work Program|A structured, motivation and self-awareness based group intervention
15766031|NCT04728074|Other|vocational rehabilitation|An individual based, focused on desired job or occupation, face-to-face intervention
15766032|NCT04728061|Drug|Gen1E-1124|Intravenously-infused Gen1E-1124 in vehicle.
15766033|NCT04728061|Drug|Placebo|Intravenously-infused vehicle.
15766034|NCT04728061|Drug|Lipopolysaccharide|Intravenously-infused lipopolysaccharide.
15766035|NCT04728048|Procedure|Dural puncture epidural|already described
15766036|NCT04728048|Procedure|Standard epidural|already described
15766037|NCT04728035|Drug|Irinotecan Liposome Injection|Irinotecan Liposome Injection
15766038|NCT04728022|Behavioral|Education program|Mentored high school summer research program
15766061|NCT04727827|Other|Pharmacogenomic-guided supportive care|Patients undergoing hematopoietic stem cell transplantation will be genotyped and supportive care therapies tailored to identified drug-gene pairs and guideline recommendations
15766039|NCT04728009|Dietary Supplement|Longan and lingzhi mushroom syrup|Fresh fruit pulps of longan were stewed in hot water until they softened. No sugar and additives were added. The pulps were removed by filtration in order to obtain concentrated longan juice. After that, spray-dried powder of lingzhi mushroom extract was dissolved in water in the ratio of 1:2. To make the finished product, 99 g of longan juice was mixed with 1 g of the lingzhi extract in water. The sugar content of the syrup was 77 degrees Brix.
15766040|NCT04727996|Drug|Sitravatinib|120 mg will be administered orally once daily
15766041|NCT04727996|Drug|Tislelizumab|200 mg will be administered intravenously (IV) once every 3 weeks
15766042|NCT04727983|Device|Electrotherapy|The first group will be given Neuromuscular Electrical Stimulation (NMES) and lifestyle suggestions (LSS) (NMES group)
15766043|NCT04727983|Device|Sham Electrotherapy|The second group will be given sham NMES in addition to LSS (SHAM ES group)
15766044|NCT04727970|Drug|Tricaprilin|Tricaprilin will be emulsified in infant formula/milk
15766045|NCT04727957|Other|Diagnostic and prognostic models for VA-LRTIs|Diagnostic and prognostic models for VA-LRTIs
15766046|NCT04727944|Other|Reach and grasp tasks in healthy participants using MEG technique (Experiment 1)|"Human participants will perform reach and grasp movements to various objects (e.g. a cube, sphere, or rod) driven either by perceived action affordances, or instruction cues. A rotating carousel will be used to present subjects with various objects affording different types of grasps (e.g. a precision pinch, a whole hand 'power' grasp, or a tripod grasp).
~Prior to the experiment, subjects will be tested outside the scanner by asking them to grasp each object as they would naturally to ensure that each object elicits the expected grasp type. Subject-specific, 3D-printed head-casts will be created based on high resolution MRI scans from each subject, and worn by subjects during the MEG experiment (Experiment 1) to reduce within-session head movement associated with reaching and grasping."
15766047|NCT04727944|Other|Reach and grasp tasks in healthy participants using EEG technique (Experiment 2)|Experiment 2 consists of a task of reaching for and grasping several objects (e.g. a cube, sphere, or rod) ; the task used for experiment 2 is the same as that used for experiment 1. EEG signals will be measured.
15766048|NCT04727931|Behavioral|Neuropsychological assessement and questionnaires|Neuropsychological assessement including memory, working memory, executive function, oral naming and speed processing tests. There are questionnaires to assess mood disorders, anxiety and cognitive reserve.
15766049|NCT04727918|Procedure|Polypectomy of diminutive colorectal polyps will be performed by CBF|All polypectomy procedures will be standardized amongst the study centers. Endoscopists with a minimal experience of at least 50 CBF and CSP performed the polypectomies CBF : The CBF will be performed using a standard biopsy forceps (Gluton Life ® Life Partners). Multiple biopsies bites were taken until complete resection (as many as needed).
15766050|NCT04727918|Procedure|Polypectomy of diminutive colorectal polyps will be performed by CSP|All polypectomy procedures will be standardized amongst the study centers. Endoscopists with a minimal experience of at least 50 CBF and CSP performed the polypectomies CSP : The CSB procedure will be performed using a 9 mm cold snare (Exacto ® Life Partners). One to two mm of normal surrounding mucosa will be ensnared around the base of the polyp, followed by mechanical excision without electrocautery
15766051|NCT04727905|Dietary Supplement|energy drink|The explosive force and muscle endurance of the lower limbs were tested first, and then the special training intervention for fire rescue was performed. Solution supplementation was carried out. The experiment group was divided into the control group and only drank 1 liter of pure water, and the sports drink group supplemented with commercially available sports drinks (using commercially available treasures). Mineral water powder configuration), mint-flavored sports drink group supplemented with mint-flavored commercially available sports drinks (using commercially available treasure mineral water powder configuration plus edible flavor 0.01% menthol)
15766052|NCT04727892|Procedure|epilepsy surgery|Surgical procedures were individually designed according to the presurgical evaluation findings. Standard epilepsy surgery procedures were applied. Generally, surgical procedures were divided into curative and palliative surgery. Curative surgery included resection and disconnection of the epileptogenic zone. Palliative surgery included corpus callosotomy for bilateral synchronous onset and multiple subpial transections for epileptic foci located in the eloquent cortex. For widespread epileptogenic zones, multiple surgical techniques were combined.
15766053|NCT04727879|Procedure|Synovial membrane biopsy with puncture of synovial fluid|The biopsy of the shoulder bursae will be carried out thanks to a device Tru-cut (Tru-Cut Biopsy Needle), minimally invasive, introduced, as during an infiltration, within the bursa serosa.
15766054|NCT04727879|Procedure|Joint fluid sampling|In case of associated peripheric arthritis, the patient will also be offered a sample of joint fluid during a cortisonic infiltration for analgesic purposes, performed as part of routine care.
15766055|NCT04727879|Procedure|Blood sample|A blood sample taken during routine care and unused will also be collected from patients and controls for immunoassays.
15766056|NCT04727866|Device|transcutaneous spinal direct current stimulation (tsDCS) - coronal|20 minutes of tsDCS will be delivered at 66% of maximum tolerated intensity with cathode over C5-C7 transverse process on target side, anode over C5-C7 transverse process on non-target side.
15766057|NCT04727866|Device|transcutaneous spinal direct current stimulation (tsDCS) - caudal|20 minutes of tsDCS will be delivered at 66% of maximum tolerated intensity with DCS cathode over ~T1-T4 posteriorly, anode over ~C5-T1 anteriorly
15766058|NCT04727866|Device|transcutaneous spinal direct current stimulation (tsDCS) - rostral|20 minutes of tsDCS will be delivered at 66% of maximum tolerated intensity with DCS cathode over ~C3-C5 posteriorly, anode over ~C5-T1 anteriorly
15766059|NCT04727853|Drug|irinotecan liposome injection|Drug: irinotecan liposome injection
15766060|NCT04727840|Drug|Sodium Zirconium Cyclosilicate Oral Product|"Sodium zirconium cyclosilicate (SZC), a non-absorbed cation exchanger, selectively binds potassium in the intestine. SZC is in a powder form and will be provided to patients in packets containing 5g or 10gm of the medication. Participants will mix the contents of one packet with water (about 45mL). The drink should be stirred and drank immediately. If powder remains in the glass, then water should be added and the remainder of the drink should be consumed. Other medications should be taken 2 hours before or after SZC.
~At Day 0 and Day 1, participants will be taking SZC at 10gm three times a day. A serum potassium will be checked on Day 2; if serum potassium is <5.1mEq/L, then the dose will be decreased to the maintenance dose of 5gm per day. At each serum potassium checks, the medication dosage will be adjusted accordingly."
15766062|NCT04727814|Other|Computer-aided detection system overlaid colonoscopy videos analysis|Analysis of computer-aided detection system overlaid videos from colonoscopies performed with water exchange or air insufflation method.
15766063|NCT04727801|Device|Verily Patch|The Verily Patch is an investigational wearable temperature sensor that consists of a Patch (Verily Patch), with swappable adhesives, as well as an app (Verily Patch app).
15766064|NCT04727775|Drug|Favipiravir|Antiviral drugs
15766065|NCT04727775|Drug|Remdesivir|Antiviral drugs
15766066|NCT04727749|Behavioral|Therapy Dog Team Visit|For the intervention group, patient interacts with the therapy dog, handler shares information about the therapy dog, asks about patient's pets, and offers a trading card of the therapy dog at the conclusion of the visit.
15766067|NCT04727736|Drug|18F-DCFPyL|18F-DCFPyL (single dose injection) - a radiolabeled prostate-specific membrane antigen (PSMA) ligand
15766068|NCT04727723|Drug|Lutathera®|Treatment with Lutathera® will be independent from participation in this observational study and must not be initiated for the purpose of participating in this study. The decision to treat patients with Lutathera® will occur before patients are enrolled in the study.
15766069|NCT04727710|Behavioral|Mindfulness-based Intervention|A self-directed, web-based mindfulness training. Investigators recommend one module a week for 6 weeks. Each module is approximately 1 hour long and consists of didactic components as well as meditation and mindfulness exercises.
15766070|NCT04727710|Behavioral|Usual Care|Standard pre-operative survivorship seminar, offered monthly to all patients at Michigan Medicine about to undergo prostatectomy and their partners is aimed at promoting realistic expectations of prostatectomy outcomes, typical side effects, rehabilitation and emotional adjustment.
15766071|NCT04727697|Other|Augmented Reality|Patients will receive the preoperative AR experience during their immediately preoperative office visit. The duration of the exposure is approximately 15 minutes.
15766072|NCT04727697|Other|Standard of Care preoperative teaching and handouts|At preoperative appointments, patients receive verbal teaching and written handouts about day of surgery instructions and expectations.
15766073|NCT04727684|Drug|Triptorelin acetate|0.05-0.1 mg subcutaneously (SC) once daily from the mid-luteal phase (day 21) of the cycle until the day of ovulation triggering.
15766074|NCT04727684|Drug|Cetrorelix|0.25 mg subcutaneously (SC) once daily starting from the day detecting a leading follicle diameter ≥ 14 mm until the day of ovulation triggering.
15766075|NCT04727684|Drug|recombinant-FSH or recombinant-FSH + human Menopausal Gonadotropin|Dosage adjustment according to the ovarian response.
15766076|NCT04727684|Drug|Human Chorionic Gonadotropin (hCG)|Ovulation will be triggered by the administration of 10,000 IU of human chorionic gonadotropin when at least three follicles become more than 16-17 mm.
15766077|NCT04727671|Drug|Triptorelin acetate|0.05-0.1 mg subcutaneously (SC) once daily from the mid-luteal phase (day 21) of the cycle until the day of ovulation triggering.
15766078|NCT04727671|Drug|Cetrorelix|0.25 mg subcutaneously (SC) once daily starting from the day detecting a leading follicle diameter ≥ 14 mm until the day of ovulation triggering.
15766079|NCT04727671|Drug|recombinant-FSH or recombinant-FSH + human Menopausal Gonadotropin|Dosage adjustment according to the ovarian response.
15766080|NCT04727671|Drug|Human Chorionic Gonadotropin (hCG)|Ovulation will be triggered by the administration of 10,000 IU of Human Chorionic Gonadotropin (hCG) when at least three follicles become more than 16-17 mm.
15766081|NCT04727658|Radiation|Radiosurgical thalamotomy on GammaKnife|fractional radiosurgical thalamotomy on an accelerator (3 sessions of 50 Gy at the isocenter )
15766082|NCT04727645|Other|Philips interventional MRI suite (Philips Healthcare, Best, the Netherlands)|iSuite is an an electroanatomical mapping system (EAM) designed to support real-time MRI guided interventional procedures.
15766083|NCT04727632|Drug|[18F]Fluoroestradiol (FES) PET/CT|[18F]Fluoroestradiol (FES) PET/CT
15766084|NCT04727619|Behavioral|SLEEP program|SLEEP is a 6-week educational program designed to improve sleep hygiene and habits.
15766085|NCT04727606|Drug|Ure-Na|"Participants in the study will receive Oral Urea (Ure-Na) treatment at a dose of 30 grams per day (2 x 15 gram pouches per day)
~Treatment will continue for approximately 1 month."
15766086|NCT04727593|Behavioral|Mindfulness Based Cognitive Therapy (MBCT)|Experimental group: MBCT is program developed by Zindel Segal, Mark Williams, and John Teasdale , based on Jon Kabat-Zinn's Mindfulness-based Stress Reduction (MBSR) program. Participants learn to acknowledge their unhelpful thoughts and feelings, allowing the mind to move from an automatic and spiraling thought pattern to a more conscious emotional processing. Mindfulness practices include breath awareness, sitting and walking meditations, and mindful yoga. In this study, the following MBCT structure will be followed: group setting of 12 participants (maximum); 8 online weekly meetings of 2 hours via a videoconference platform (e.g., Cisco Webex), each one mediated by a trained mindfulness instructor(s); daily home practice of the learned skills; 2 hours of retreat after the fifth week; 6 months of home practice; 4 monthly consolidation sessions of 90 minutes each.
15766087|NCT04727593|Other|Treatment as Usual|In this case, participants will follow the usual institutional intervention protocol for medical follow-up and identification, referral, and intervention for people with significant distress difficulties. Regarding pharmacological intervention, medication intake will be monitored during the study and changes will be registered. The engagement in non-pharmacological interventions such as psychological and psychosocial interventions will also be monitored.
15766088|NCT04727580|Drug|HSK7653 10mg Q2W|HSK7653 5mg (2 tablets) and placebo of HSK7653 25mg (1 tablet) Q2W, oral, Day1 to week12
15766089|NCT04727580|Drug|HSK7653 25mg Q2W|HSK7653 25mg (1 tablet) and placebo of HSK7653 5mg (2 tablets) Q2W, oral, Day1 to week12
15766090|NCT04727580|Drug|Placebo|Placebo of HSK7653 25mg (1 tablet) and placebo of HSK7653 5mg (2 tablets) Q2W, oral, Day1 to week12
15766091|NCT04727554|Drug|AMG 994|Administered as an intravenous (IV) infusion.
15766092|NCT04727554|Drug|AMG 404|Administered as an intravenous (IV) infusion.
15766093|NCT04727541|Drug|Bintrafusp alfa|Neoadjuvant therapy with bintrafusp alfa
15766094|NCT04727528|Drug|Sodium zirconium cyclosilicate|Investigational medicinal product
15766095|NCT04727528|Drug|Placebo|Plabeco comparator
15766096|NCT04727515|Drug|fentanyl 2µg/kg intravenously and maintained with isoflurane|Anesthesia will be induced using titration of intravenous propofol till loss of verbal contact and fentanyl 2µg/kg intravenously and maintained with isoflurane (end tidal up to 1.5%), oxygen in air 50:50 via a laryngeal mask.
15766097|NCT04727515|Procedure|Axillary nerve Block|Axillary block will be performed using ultrasound technique. Patients will receive an axillary block under ultrasound guidance using a linear 5-12 MHz probe.
15766098|NCT04727502|Drug|Duloxetine|duloxetine
15766099|NCT04727502|Drug|Pregablin|Pregablin
15766100|NCT04727489|Genetic|DNA from subjects will be stored in the biobank of our study.|Diagnostic Interview-Revised (ADI-R) criteria for autism and Autism Diagnostic Observation Schedule (ADOS-G) criteria for autism or Autism Spectrum Disorders.
15766101|NCT04727476|Drug|Lisdexamfetamine|Prescription of lisdexamfetamine sometime during til period from 1 April 2013 to 5 November 2019.
15766102|NCT04727463|Procedure|Sphincteroplasty|Overlapping sphincteroplasty
15766103|NCT04727450|Behavioral|Cognitive training|Involves participants engaging in selected games which require thinking skills to be played in a group of 2-4 people.
15766104|NCT04727450|Behavioral|physical training|"Involves learning of preselected routines of line dancing taught by a line dance instructor."
15766105|NCT04727450|Behavioral|Combination of cognitive and physical training (CCPT)-BIGMAP|BIGMAP is a program engaging participants in specially designed cognitive/memory games together with physical training (Fu & Chow, 2019).
15766106|NCT04727437|Other|No treatment|Withholding anticoagulation for at least 3 months.
15766107|NCT04727437|Drug|Warfarin|anticoagulation drug given for at least 3 months.
15766108|NCT04727437|Drug|direct oral anticoagulants|anticoagulation drug given for at least 3 months.
15766109|NCT04727437|Drug|Low molecular weight heparin|anticoagulation drug, subcutaneous injection given for at least 3 months.
15766110|NCT04727424|Drug|Fluvoxamine Maleate 100 MG [Luvox]|One tablet every 12 hours since randomization through day 09.
15766111|NCT04727424|Drug|Doxazosin 2 Mg Oral Tablet|One to four tablets daily, as per uptritation schedule up to 08 mg/ day since randomization through day 13.
15766112|NCT04727424|Drug|Ivermectin 06 mg Oral Tablet|Oral tablets administered once a day for three consecutive days (as of randomization day 0).
15766113|NCT04727424|Drug|Placebo|"Placebo SC normal saline syringe (single day dosing schedule):
~Matching syringes containing 0,5 ml normal saline will be administered by SC route just after randomization Day 0 (single dose SC administration).
~OR
~Placebo oral tablets (3-day dosing schedule):
~Matching tablets started right after randomization using the dosing regimen of a medium 400mcg/ kg up to 90 kg weight, administered once a day for three consecutive days (including randomization day, which is designed as Day 0).
~OR
~Placebo oral tablets (10-day dosing schedule):
~Matching tablets started right after randomization using the dosing regimen of 01 tablet every 12 hs starting at Randomization Day (Day 0) until end of Day 09 (total of 10 day schedule)
~OR
~Placebo oral tablets (14-day dosing schedule):
~Matching tablets started right after randomization (Day 0) until Day 3, when uptritation of tablets will happen as per protocol, up to 4 pills daily (08 mg/ day) ending on Day 13."
15766114|NCT04727424|Drug|Peginterferon Lambda-1a|One syringe of 180 mcg of Peginterferon Lambda SC right after randomization Day 0 (single dose SC administration).
15766115|NCT04727424|Drug|Peginterferon Beta-1A Prefilled Syringe|One syringe of 125 mcg of Peginterferon Beta SC right after randomization Day 0 (single dose SC administration).
15766116|NCT04727411|Procedure|XEN45 Gel stent|XEN Gel stent implantation either combined or as a stand-alone procedure
15766117|NCT04727411|Procedure|Trabeculectomy|XEN Gel stent implantation either combined or as a stand-alone procedure
15766118|NCT04727398|Device|Wide-field optical coherence tomography (Optovue®)|Merged 4 images for wide-filed OCT-based PVD classification, 2 vertical line images and 2 horizontal line images
15766119|NCT04727385|Device|Double Crosslink Microgel|"DXM hydrogel is a pH responsive Double Cross-Linked microgel based on single internally cross-linked microspheres (comprising a methacrylic acid-methyl methacrylate-ethylene glycol dimethacrylate copolymer)
~The DXM gel is injected into the intervertebral disc (IVD) space via a standardised procedure similar to the routinely-performed Discography procedure. The disc approach described in the discography procedure has been reported to allow the injection of a solution in the centre of the disc. The injection of the gel takes about 2 min."
15766120|NCT04727372|Other|Questionnaire|A structured questionnaire will be served to each participant of study after getting the verbal consent from him for inclusion into the study
15766121|NCT04727359|Other|FIT64b model project|FIT64b model project: The SHI funds AOK Baden-Württemberg and SVLFG (as an agricultural health insurance fund) have established a contract (duration = at least eight year) with the model hospital for an alternative remuneration / financing of patients treated in the model hospital (FIT64b hospital, UKT). This contract encourages the model hospital an alternative treatment of their patients (with the above mentioned SHI fund), for example fewer inpatient and more outpatient treatment.
15766122|NCT04727346|Radiation|CBCT|Cone Beam Computed Tomography
15766123|NCT04727346|Procedure|DISE|Drug Induced Sleep Endoscopy
15766124|NCT04727320|Drug|Tauroursodeoxycholic acid|Oral TUDCA, once a day, one tablet (250mg) at a time for 6 months
15766125|NCT04727320|Drug|Placebo|Oral placebo, once a day, one tablet at a time for 6 months
15766126|NCT04727307|Drug|Atezolizumab (neoadjuvant)|Atezolizumab 1200mg will be delivered as an IV infusion on Day 1 of each cycle (every 3 weeks) in neoadjuvant, for 2 cycles. The initial dose will be delivered over 60 (± 15) minutes and if tolerated subsequent infusions may be given over 30 (± 10) minutes.
15766127|NCT04727307|Procedure|Percutaneous Radiofrequency|Any RFA system (uni/multi-needle, monopolar or multi-bi-polar) is allowed. Microwave ablation or irreversible electroporation is not allowed.
15766128|NCT04727307|Drug|Bevacizumab (adjuvant)|Bevacizumab 15 mg/kg will be delivered as an IV infusion on Day 1 of each 3 week cycle in adjuvant, for 15 cycles maximum. The initial dose will be delivered over 90 minutes (±15 minutes) and if tolerated subsequent infusions may be given over 60 (± 10) minutes then over 30 (± 10) minutes.
15766129|NCT04727307|Drug|Atezolizumab (adjuvant)|Atezolizumab 1200 mg will be delivered as an IV infusion on Day 1 of each cycle (every 3 weeks) in adjuvant, for 15 cycles maximum. The dose will be delivered over 30 (± 10) minutes.
15766130|NCT04727294|Behavioral|Questionnaire|Series of questions covering COVID-19 diagnosis and treatment, changes in myeloma treatment and care, clinical trial familiarity, health and fitness, and quality of life.
15766169|NCT04726982|Drug|Acetazolamide|500 mg once daily
15766170|NCT04726982|Other|Placebo|Once daily
15766171|NCT04726969|Drug|Moxidectin 2 mg Oral Tablet|Tablets of 2 mg moxidectin
15766131|NCT04727281|Other|Quality of life assessment using the Kidney Disease Quality of Life 36 (KDQOL-36) short form and Malnutrition-Inflammation Score|"Data about nutritional status using the Malnutrition-Inflammation Score, and Quality of life assessment using the Kidney Disease Quality of Life 36 (KDQOL-36) short form. Dialysis related data, The time needed for the patient to recover from a dialysis session (in minutes), Detailed history taking, Thorough physical examination, Laboratory Investigations:
~• Hemoglobin , Serum sodium and potassium , Serum creatinine and blood urea , Serum phosphorus, serum calcium , Serum PTH level , Serum albumin ,CRP ,Total iron-binding capacity ."
15766132|NCT04727268|Other|No intervention|No interventions present in this study.
15766133|NCT04727255|Behavioral|Engaged and Resilient intervention|"Engaged and Resilient is a 3-phase program addressing the promotion of psychological resilience strategies for leaders.
~To implement resilience training as a strategic and ethical intervention in the organization, stakeholders from Management/HR will be involved in the final design of the training program based on local institutional data, and the baseline measure result. Local training sessions will be selected from a bag-log of resilience skills structured by three general resilience factors.
~To support ownership and internal sustainability, internal trainers will be educated on how to train the resilience skills in the program.
~The Engaged and Resilient program consists of 20 short-term sessions for leaders based on cognitive and positive psychology."
15766134|NCT04727242|Drug|Gemcitabine|Hyperthermic intraperitoneal chemotherapy (HIPEC) with gemcitabine. Gemcitabine will be instilled at a dose of 1000 mg/m2 for 60 minutes at temperatures of 42° to 43°C.
15766135|NCT04727242|Drug|Dacarbazine|Dacarbazine 1000 mg/m2 IV every 3 weeks x 6 cycles given IV
15766136|NCT04727242|Procedure|Cytoreductive Surgery|Surgery for cancer removal
15766137|NCT04727242|Behavioral|Functional Assessment of Cancer Therapy (FACT) G questionnaire|Preoperative and Postoperative FACT G questionnaire to assess QoL
15766138|NCT04727242|Procedure|Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) Scan|Radiologic imaging after Cycle 3 and 6 and at each follow up visit
15766139|NCT04727242|Drug|Gadolinium|Contrast Agent
15766140|NCT04727229|Drug|Bupivacaine Hydrochloride|Injection of Bupivacaine near the stellate ganglion
15766141|NCT04727229|Drug|Normal Saline|Injection of Normal Saline near the stellate ganglion
15766142|NCT04727216|Device|Dorsal Root Ganglion Stimulation (DRG-S)|Dorsal Root Ganglion stimulation will be delivered with continuous dosing and 2 different ON/OFF periods to compare effects for each patient.
15766143|NCT04727203|Behavioral|AHAA|Multi-component healthy lifestyle program
15766144|NCT04727190|Procedure|Transbronchial Cryobiopsy|The eligible patient will be randomized to TBCB group to receive transbronchial cryobiopsy.
15766145|NCT04727190|Procedure|Transbronchial Forceps Biopsy|The eligible patient will be randomized to TBFB group to receive transbronchial forceps biopsy.
15766146|NCT04727177|Device|Transcranial magnetic stimulation|Transcranial magnetic stimulation (TMS) is a noninvasive biological stimulation technique born in the middle of 1980's.
15766147|NCT04727164|Drug|HBM4003 and Triprilimab|Subjects will be treated with HBM4003 on Day 1 Cycle 1 and be treated with HBM4003 and Triprilimab during each 21-day cycles from Cycle 2 in part 1.Subjects will be treated with HBM4003 and Triprilimab on Day 1 during each 21-day cycle in part 2.
15766148|NCT04727151|Biological|TAC01-HER2|TAC01-HER2, fludarabine, cyclophosphamide.
15766154|NCT04727112|Drug|Usual care versus primary care|RCT study
15766155|NCT04727099|Device|PicoWay Laser System|The PicoWay® laser system is an alexandrite laser pumped, solid-state Neodymium:Yttruium Aluminum Garnet (Nd:YAG) laser emitting energy at user selectable wavelengths of 1064 nm, 532 nm, 785 nm or 730 nm, designed for the treatment of tattoo, benign pigmented lesions, acne scars, and wrinkles.
15766156|NCT04727086|Drug|BP1.3656|BP1.3656 will be administered in tablet form once daily at a dose of 30 µg/day for the first 4 days of the intervention phase, followed by a dose increase to 60 µg/day for the remaining 10 days. If the highest dose is not tolerated, it will be lowered to 30 µg.
15766157|NCT04727086|Drug|Placebo|Administered once daily in tablet form.
15766158|NCT04727073|Drug|Experimental: Spironolactone|Spironolactone (an aldosterone antagonist) in tablet form taken daily. The initial study drug dose is 25 mg/day (one tablet) and may be titrated up to 50 mg/day (two tablets) within 4 weeks if kidney function at VR was > 30 mL/min/m2 and potassium < 4.5 mmol/L.
15766159|NCT04727073|Drug|Placebo Comparator|Placebo of Spironolactone in tablet form taken daily with dosage escalation rules in accordance with dosage of the study drug Spironolactone.
15766160|NCT04727060|Device|patient with knee arthroplasty|
15766161|NCT04727047|Device|neuromuscular electrical stimulation|All subjects will receive standard rehabilitation for Achilles tendon repair. In addition, neuromuscular electrical stimulation will be applied to the calf muscles of the injured leg. The stimulation volume, the electrode placement and the intensity of the stimulation will be selected based on the mechanical strength of healing Achilles tendon. The intervention will be applied for 6 weeks after repair.
15766162|NCT04727034|Drug|Remimazolam tosylate|Remazolam tosylate is an ultra-short-acting benzodiazepine drug, which has a mild inhibitory effect on the respiratory and circulatory systems and has anterograde amnesia. These advantages make remazolam tosylate very likely to replace propofol in painless gastroscopic anesthesia.
15766163|NCT04727034|Drug|Propofol|Propofol is the most commonly used intravenous anesthetic for painless gastroscopy, but propofol significantly inhibits the respiratory and circulatory systems. Therefore, the incidence of intraoperative hypoxemia and hypotension is high.
15766164|NCT04727021|Drug|20 mg tablet rivaroxaban|Single oral dose of a 20 mg tablet rivaroxaban, administered under fed conditions
15766165|NCT04727021|Drug|20 mg rivaroxaban, granules for oral suspension|Single oral dose of 20 mg rivaroxaban, granules for oral suspension administered under fed conditions.
15766166|NCT04727008|Biological|CXCR4 modified anti-BCMA CAR T cells|intravenous infusion
15766167|NCT04726995|Other|CHOP and BFM regiments|used CHOP and BFM regiments
15766168|NCT04726982|Drug|Acetazolamide|250 mg once daily
15766172|NCT04726969|Drug|Albendazole 400 mg Oral Tablet|Tablets of 400 mg albendazole
15766173|NCT04726969|Drug|Ivermectin 3 mg Oral Tablet|Tablets of 3 mg ivermectin
15766174|NCT04726943|Procedure|Radiofrequency Energy Applications|RF energy applications to the atrial edge of a leak resulting from incomplete LAA occlusion
15766175|NCT04726930|Procedure|Intercostal nerve blocks|Intercostal nerve block is a regional anesthetic procedure for peri-operative pain management. It inhibits the action of the ipsilateral sensory and motor branches, and produces analgesic effects at the targeted thoracic level.
15766176|NCT04726930|Procedure|Paravertebral block|Paravertebral block is the technique of injecting local anesthetic alongside the thoracic vertebra close to where the spinal nerves emerge from the intervertebral foramen. This produces unilateral, segmental, somatic, and sympathetic nerve blockade, which is effective for anesthesia and in treating acute and chronic pain of unilateral origin from the chest and abdomen
15766177|NCT04726917|Behavioral|Pulmonary rehabilitation|Patients qualified for rehabilitation were assessed for stress levels as well as symptoms of anxiety and depression before rehabilitation began
15766178|NCT04726904|Procedure|Sacral neuromodulation in conventional implantation technique|Sacral neuromodulation is implanted with the patients in a prone position, then the insert point of the needle is decided according to anatomical landmarks; afterwards, the lead will be inserted.
15766179|NCT04726891|Behavioral|Movement-2-Music + Social Networking Support|The primary goal of the proposed research is to conduct a 12-week pilot study of the SMART-HEALTH intervention in 30 individuals with SCI. There are several unique features of this study design, including a novel adapted exercise program (M2M), instructor-led, individualized training (M2M Live; described in D.2.1), individualized behavioral coaching, and social networking support.
15766180|NCT04726878|Procedure|Erector spinae plane block|Ultrasound-guided the erector spinae plane block with 0.375% ropivacaine, 0.4 mL per KG, up to 40 mL (maximum dose).
15766181|NCT04726878|Procedure|Sham block|Ultrasound-guided the erector spinae plane block with 0.9% saline, 0.4 mL per KG, up to 40 mL (maximum dose).
15766182|NCT04726878|Procedure|General anesthesia|"Standard general anesthesia. The induction with fentanyl, 1-3 mcg per KG; propofol, 1.5-2 mg per kg. Then, the laryngeal mask airway will be inserted. Patients with the risk of aspiration will be intubated using rocuronium or suxamethonium.
~The maintenance with oxygen/air mixture, sevoflurane, and fentanyl."
15766183|NCT04726878|Procedure|Patient-controlled analgesia|All patients will receive a PCA pump with oxycodone (1 mg/mL, 5-minute interval) after transfer to PACU (post-anesthesia care unit)
15766184|NCT04726878|Drug|Oxycodone|Intravenous oxycodone will be administered about 30 minutes before the end of the surgery at a dose of 0.1 mg/KG. Additional 2 doses can be given if pain on the visual analog scale will be higher than 40.
15766185|NCT04726878|Drug|paracetamol|intravenous paracetamol will be used (1.0 gram), up to 4 grams per day
15766186|NCT04726865|Other|Naser Al-Husban|voluntary completion of an online questionnaire
15766187|NCT04726852|Device|Concurrent comparison|Concurrent comparisons at defined procedure events
15766188|NCT04726839|Other|Standard of care for stroke management and evaluation of functionnal outcome at 3 months|Additional tubes at inclusion (maximum 13 mL) Collection of the mRS data during a routine visit if planned at 3 months +/-15 days or, if not during a specific research phone call at 3 months
15766189|NCT04726826|Diagnostic Test|Diagnostic and prognostic biomarkers|Observational study of biomarkers predictive of morbidity and mortality in febrile children
15766190|NCT04726813|Behavioral|MyADHD|The main goals of the intervention are to help participants with better functioning in daily life; offer strategies that will lead to stress reduction and reduce inattention and improve quality of life.The intervention includes: a short introductory chapter (open to everyone), followed by a start module (goal setting), followed by 6 different themed optional modules. Module content is based on GMT, DBT and CBT techniques and is tailored towards key concerns and difficulties experienced adults with ADHD as informed by previous research (focus-groups, lived experience groups) and experiences from group GMT and DBT.
15766191|NCT04726813|Behavioral|Psychoeducation|Participants in the control condition will be assigned to psychoeducation modules (see Table 2) and will receive restricted access to the platform. They can contact or be contacted if their symptoms levels increases.
15766192|NCT04726787|Radiation|Bridging Radiotherapy|Bridging Radiotherapy will start immediately after leukapheresis and before Tisagenlecleucel treatment
15766193|NCT04726774|Behavioral|Hypnosis|"Two sessions of hypnosis, about 30 minutes each, weekly provided, by a physician trained in medical hypnosis.
~Each session was realized as possible during walking, according to the agreement and the physical status of the participant.
~Each sessions of hypnosis includes 3 phases : induction, walk perception alteration and post-hypnotic suggestion."
15766194|NCT04726774|Behavioral|Rehabilitation program|Intensive physiotherapy for 2 weeks, with walking and balance exercises, (individual and group exercises). Education of risk of falling and prevention of falls.
15766195|NCT04726761|Diagnostic Test|Ambulatory Blood Pressure Monitoring, frequent/non-frequent|Patient will have a Spacelabs 90217 attached. This device can automatically measure the blood pressure over 24 hours. Patients will have their blood pressure measured first with a frequent interval, and then a non-frequent interval.
15766196|NCT04726761|Diagnostic Test|Ambulatory Blood Pressure Monitoring, non-frequent/frequent|Patient will have a Spacelabs 90217 attached. This device can automatically measure the blood pressure over 24 hours. Patients will have their blood pressure measured first with a non-frequent interval, and then a frequent interval.
15766197|NCT04726748|Procedure|Comparisons between the Prostatic urethral lift (PUL) and the TURP/Laser cohorts|"Comparison between the PUL and the TURP/Laser cohorts will be performed after 1 year and 3 years of follow-up in a intention-to-treat analysis using:
~a linear regression model when it involves quantitative variables,
~a logistic regression model adjusted on potential confounding when it involves qualitative variables."
15766198|NCT04726748|Procedure|Comparison between the Prostatic urethral lift (PUL) and the SNDS cohorts|"Comparison between the PUL and the SNDS cohorts will be performed after 1 year and 3 years of follow-up in a intention-to-treat analysis using:
~a linear regression model when it involves quantitative variables,
~a logistic regression model adjusted on potential confounding when it involves qualitative variables."
15766199|NCT04726735|Biological|Samples of bladder tissue|Samples of bladder tissue collected between 2007 and 2011.
15766256|NCT04726293|Dietary Supplement|Control|control beverage 1 cup, twice a day for 4 weeks
15766200|NCT04726722|Behavioral|internet-based cognitive behavioral theraphy|"When determining the content of the I-CBT program, the participants and therapist will be allowed to choose from a library of treatment modules.
~Therapist controlled support and feedback are given weekly and in a structured manner. Participants will be able to contact the therapist when support and feedback is desired"
15766201|NCT04726709|Behavioral|Poised for Parkinson's|Lecture, demonstration, activities, and supplemental materials designed to improve self-awareness, situational awareness, and ability to make good choices for physical and emotional self-care, moment-to-moment.
15766202|NCT04726696|Behavioral|ROLE-AP programme|The intervention group will be split in two groups of 7-8 primary care nurses each. These two groups will receive the ROLE-AP program over a three weeks period. Each workshop will be divided into two sessions of 90-120min. The first workshop focuses on the clarification of health promotion concepts and the discussion of the state of nursing practice in health promotion. Participants will discuss the misalignments between this description of nursing practice and the ideal one portrayed by the Ottawa Charter. The second workshop will allow the presentation of the objectives of the health care organization, showing its alignment with the Ottawa Charter areas of action. In addition, it will present a standardized instrument that reflects expectations about nurses' activities in health promotion that will serve for discussing and realigning participants' expectations on nurses' role in health promotion. The third workshop will continue with the discussion of nurses' expected activities.
15766203|NCT04726683|Procedure|Dry needling and placebo injection|Dry Needling is applied with a filiform needle to penetrate the skin and stimulate the underlying myofascial trigger point of the masseter muscle. Dry needling is combined with placebo injection, in which the tip of a beveled needle is cut and the process of injection is simulated without penetrating the skin.
15766204|NCT04726683|Procedure|Injection and placebo dry needling|Lidocaine injection applied in the myofascial trigger point of the masseter muscle. Lidocaine injection is combined with placebo dry needling, in which the tip of a filiform needle is cut and the dry needling technique simulated without penetrating the skin
15766205|NCT04726683|Procedure|Dry needling and injection|Dry Needling is applied with a filiform needle to penetrate the skin and stimulate the underlying myofascial trigger point of the masseter muscle. Dry needling is combined with lidocaine injection applied in the myofascial trigger point of the masseter muscle.
15766206|NCT04726683|Procedure|Placebo dry needling and placebo injection|Placebo dry needling, in which the tip of a filiform needle is cut and the dry needling technique simulated without penetrating the skin. Placebo dry needling is combined with placebo injection, in which the tip of a beveled needle is cut and the process of injection is simulated without penetrating the skin
15766207|NCT04726670|Other|Evaluation of postoperative pain|"A participant voluntary consent form was obtained from each patient. Ninety patients were numerically coded in computer environment by someone who was not included in the study for randomization (www.random.org).
~A single clinician performed retreatment on each of the 90 teeth during a single visit."
15766208|NCT04726657|Drug|Premixed Human Isophane Insulin Suspension + Human Insulin Injection|premixed human insulin
15766209|NCT04726657|Drug|Premixed Insulin|Premixed Insulin Analog Biphasic Aspart 30
15766210|NCT04726644|Procedure|hernia repair|different methods for hernia repair
15766211|NCT04726631|Drug|Basal insulin analogue|Analogue insulin is a sub-group of human insulin
15766212|NCT04726631|Drug|rapid acting insulin|Rapid acting insulins are usually taken just before or with a meal. They act very quickly to minimise the rise in blood sugar which follows eating.
15766213|NCT04726631|Drug|Neutral Protamine Hagedorn|is an intermediate-acting insulin
15766214|NCT04726631|Drug|regular insulin|is a type of short-acting insulin.
15766215|NCT04726618|Drug|Hyperpolarized 129-xenon gas and Perfluoropropane gas|"Hyperpolarized 129-xenon gas will be used as a contrast agent for MRI. Xenon will be inhaled by the participant at a maximum dose volume of 1/6 of the participant's total lung capacity.
~Perfluoropropane will also be used as a contrast agent for MRI. Perfluoropropane will be inhaled as a normoxic mixture (21% O2 and 79% perfluoropropane)."
15766216|NCT04726592|Drug|Clorazepate Dipotassium|Clorazepate Dipotassium : 20 mg intravenous injection
15766217|NCT04726592|Drug|Placebo|Placebo IV
15766218|NCT04726592|Drug|Ketoprofen|Ketoprofen 100 mg IV
15766219|NCT04726592|Drug|Metoclopramide|Metoclopramide 10 mg IV
15766220|NCT04726566|Procedure|Tendon graft|Anatomical surgery for chronic lateral ankle instability under arthroscopy with tendon graft
15766221|NCT04726566|Procedure|Suture with biological reinforcement|Anatomical surgery for chronic lateral ankle instability under arthroscopy by suture with biological reinforcement
15766222|NCT04726553|Drug|Anifrolumab|Anifrolumab is a monoclonal antibody which inhibits the Interferon alpha beta receptor (IFNAR) which is the main transducer of signals from Type I interferons.
15766223|NCT04726553|Drug|Standard of Care|Standard of Care treatments for Systemic Lupus Erythematosus
15766224|NCT04726540|Other|Patient Satisfaction|Patients were then asked to grade their overdentures/dentures on a visual analog scale and written questionnaire to evaluate their overall satisfaction.
15766225|NCT04726527|Drug|Florbetapir F 18|A single injection of 10 mCi (370 MBq) florbetapir F 18 will be administered by intravenous bolus injection.
15766226|NCT04726527|Device|Positron Emission Tomography|PET Scan for brain imaging
15766227|NCT04726514|Device|SleepFlex|SleepFlex Program
15766228|NCT04726501|Other|Combined chemotherapy with or without involved-field radiotherapy|Patients in low risk group receive 4 cycles of AVE-PC with or without involved-field radiotherapy (IFRT). Patients in intermediate risk group4 cycles ABVE-PC with or without IFRT. RERs in high risk group receive 4 cycles of ABVE-PC followed by followed by IFRT. SERs in high risk group receive 2 cycles of ABVE-PC followed by 2 cycles of IFOS/VINO and 2 cycles of ABVE-PC then followed by IFRT. IFRT consists of 21 Gy in 14 fractions of 1.5 Gy per day and is scheduled within 4 weeks after chemotherapy.
15766229|NCT04726488|Procedure|Periareolar Approach in Minimally Invasive Cardiac Surgery (PAMI Technique)|"To study the feasibility and safety of periareolar minimally invasive surgery protocol in patients undergoing periareolar minimally invasive surgery vs. Control group (inframammary approach)."
15766230|NCT04726488|Procedure|inframammary approach|"To study the feasibility and safety of periareolar minimally invasive surgery protocol in patients undergoing periareolar minimally invasive surgery vs. Control group (inframammary approach)."
15766231|NCT04726475|Behavioral|Memory Reactivation|"A script-driven imagery approach adapted from prior research (see Brunet et al., 2018) will be used for the memory reactivation procedure. Specifically, participants will be instructed to write a brief one-page narrative in the present tense, first-person singular, focusing on their worst panic attack's most disturbing moments. The participant will then be asked to read the narrative aloud as if they were back in the event and record it on a recording device. Lastly, the participant will be asked to close their eyes and listen to their recording once while focusing intensely on their panic memory."
15766232|NCT04726475|Dietary Supplement|Cannabidiol (CBD) Oil|Participants will be asked to take a single 300mg oral dose of a hemp-derived formulation of purified isolate cannabidiol oil. Study CBD was prepared by Way West Hemp Inc. and cannabinoid potency testing has been performed by Botanacor Laboratories. Botanacor conducts potency testing that is in accordance with FDA-compliant Pharma practices.
15766233|NCT04726475|Dietary Supplement|Placebo Oil|Participants will be asked to take a single 300mg oral dose of MCT oil.
15766234|NCT04726462|Other|Functional exercises|The exercise program is planned as a function-oriented exercise program aimed at improving balance skills, increasing lower extremity muscle strength and functions.
15766235|NCT04726462|Other|Posture exercises|The exercise program was planned by focusing on posture exercises in order to increase the postural smoothness of the participants.
15766236|NCT04726449|Other|Screening for acute confusional state|The intervention will consist of two psychometric test to screen for acute confusional state with the usual physical examination by the emergency physician. The neurological examination abnormalities will be noted
15766237|NCT04726436|Other|Dextrose 5% in water|One hour before operation, patients were given dexrose 5%100/hour only for 2 hours to end at about middle of surgery
15766238|NCT04726436|Other|Dextrose 10%|One hour before operation, patients were given dexrose 10 %100/hour only for 2 hours to end at about middle of surgery
15766239|NCT04726436|Other|Saline placebo|One hour before operation, patients were given normal saline100/hour only for 2 hours to end at about middle of surgery
15766240|NCT04726423|Other|transcranial direct current stimulation|5 daily sessions of tDCS (2mA, 20 min) were recommended to all patients. Physical exercises were also done at the physiotherapy clinic. Physical exercises program was recommended to be continued at home after the week of physiotherapy visits.
15766241|NCT04726410|Biological|Cold Stored Platelets|early infusion of urgent release CSP
15766242|NCT04726410|Biological|Standard Care|standard care including room temperature platelets
15766243|NCT04726397|Radiation|Reduced margin adaptive radiotherapy|Reduced (5 mm) clinical target volume margin with weekly contrast-enhanced adaptive radiation on the MR-Linac treatment machine
15766244|NCT04726384|Device|Assessment of physical activity level|Physical activity was assessed using the Sensewear Armband device. Patients received the device on Thursday mornings, prior to exercise and treatments. The device was placed on the right arm throughout the study. Patients in whom the device monitored a minimum of 95% of the time of the study day were analyzed. Prior to the study, the devices were programmed to record a minimum level of intense (>3MET) and moderate ( >6MET) exercise.
15766245|NCT04726371|Behavioral|Generic Best Practices|GBP consists of (1) Massachusetts Executive Office of Health and Human Services distribution of standard guidelines and policies for public health prevention and management of COVID and (2) standard virtual training of the staff of the group homes in these generic COVID-19 prevention practices including recommended use of hand washing, use of PPE, and symptom-triggered screening. Group homes randomized to this intervention will receive standard recommended and fully vetted best practices with respect to preventing and managing COVID-19 based on recommendations by the CDC and on consultation with leading national experts in infectious disease working with the Commonwealth of Massachusetts. The control condition does not represent inferior or substandard practice. As findings occur and as policy leads to adjustments in recommendations during the course of the study, the GBP condition will incorporate recommendations that are appropriate and up-to-date with CDC and state policy.
15766246|NCT04726371|Behavioral|Tailored Best Practices|TBP consists of optimized, tailored, and highly specific COVID-19 best practices and training materials specific to the setting, staff, and residents with SMI and ID/DD in congregate living settings based on the comparative effectiveness of different types, intensities, and combinations of COVID-19 prevention practices (screening, isolation, contact tracing, use of PPP, vaccination) specifically modeled for residents and staff of congregate living settings for people with ID/DD and SMI derived by a simulation model. Results from this modeling process will be provided to stakeholders to support decision makers in prioritizing resources and practices with the greatest impact on reducing COVID-19 tailored for people with SMI and ID/DD in congregate living settings. This process to determine the content of TBP will occur as part of this study prior to randomization.
15766247|NCT04726345|Drug|Fexofenadine Hcl 180Mg Tab|Fexofenadine 180mg tablet to be taken orally once a day until stent removal.
15766248|NCT04726345|Drug|Placebo|Placebo tablet to be taken orally once a day until stent removal.
15766249|NCT04726332|Drug|XL102|oral doses of XL102
15766250|NCT04726332|Drug|Fulvestrant|fulvestrant 500 mg administered as an intramuscular (IM) injection every 2 weeks for the first 3 doses and then every 4 weeks.
15766251|NCT04726332|Drug|Abiraterone|abiraterone 1000 mg administered orally once daily.
15766252|NCT04726332|Drug|Prednisone|prednisone 5 mg administered orally twice daily.
15766253|NCT04726319|Other|FHAMe Intervention|Patients will receive an invitation email prior to their scheduled clinical visit which includes information about the study, a link to the YouTube patient presentation, and a link to the consent form and questionnaire. Patients will be invited to fill out the questionnaire prior to their appointment. After patients complete the initial questionnaire, physicians will receive an EMR message on the day of patient's clinic visit alerting them that patient family history information is available and to complete the Family History Action Form. They will be prompted to respond to the message which will open the action form and ask what action the provider intends to take with this family history information. The form will then link to management support tools for use during the patient visit. All participants will attend their clinical visit after which they will receive a post-visit electronic survey regarding their clinical visit and whether family history was reviewed with their provider.
15766254|NCT04726306|Diagnostic Test|Otic Barotrauma Grading System|Otic Barotrauma Grading System Placards for TEED Score and the OGS grading system.
15766255|NCT04726293|Dietary Supplement|Mango|Mango beverage -1 cup fresh mango equivalent, twice a day for 4 weeks
15766257|NCT04726280|Drug|Ropivacaine 0.75% Injectable Solution|10 ml extrafascial interscalene brachial plexus block
15766258|NCT04726280|Drug|Ropivacaine 0.75% Injectable Solution|20 ml extrafascial interscalene brachial plexus block
15766259|NCT04726267|Device|Wide-field optical coherence tomography|Merged 4 images of wide-field optical coherence tomography, 2 images of vertical scan and 2 images of horizontal scan.
15766260|NCT04726241|Procedure|Biospecimen Collection|Undergo collection of blood and/or bone marrow samples
15766261|NCT04726215|Drug|[18F]F AraG|PET imaging agent specific to activated T cells
15766262|NCT04726202|Other|Standard procedure|Coding of cases follows the standard procedures established at the hospital
15766263|NCT04726202|Other|precoding|"Standard coding will be reviewed by dedicated physicians and corrected or extended if necessary.
~Coding will compared to the written OP report for consistency. Dedicated physician visits patients daily (in addition to routine visits). Dedicated physicians review discharge report and will make changes and additions. DRG coding will be adapted to results from visits and discharge report."
15766264|NCT04726189|Other|Standard exercises|Consists of a a standard exercise program with range of motion exercises from the third week and elastic band exercise from the sixth week.
15766265|NCT04726189|Other|Standard exercises plus Early progressive exercises|This exercise program consists of standard exercises plus the early progressive program that initiates early (second week) and continues with resistance exercises with progression of the load according to individual participant toleration. Exercises are isometric exercises from the second week and then gradually progression of load in seated heel-rise and resistance band exercises.
15766267|NCT04726163|Device|Continuous blind glucose measurement device (Free style Pro)|A continuous blind glucose measurement device (Free style Pro) will be set up on the first day and throughout the entire hospital stay
15766268|NCT04726150|Other|ILR implantation|If LGE is present on CMR, ILR implantation will be proposed
15766269|NCT04726124|Device|Microwave Ablation Therapeutic Apparatus|The selected and qualified subjects with primary lower extremity varicose veins were randomly treated with microwave ablation equipment or laser treatment equipment. Subjects in the two groups were returned to the hospital for follow-up at 7 days, 3 months and 6 months after surgery, respectively, for ultrasound examination and questionnaire evaluation, medication status and adverse events were recorded, and target lesion closure rate and subject satisfaction were evaluated.
15766270|NCT04726111|Other|Specimens specific for the study|Specimens (blood, umbilical cord, umbilical cord blood, placenta)
15766273|NCT04726085|Drug|Indomethacin 150mg|Patients will be randomized to either received perioperative indomethacin or ibuprofen at the time of their emergent cerclage placement for 24 hours following surgery. Patient will be followed up through our electronic medical record system to determine gestational latency to evaluate if ibuprofen is inferior to indomethacin.
15766274|NCT04726085|Drug|Ibuprofen 2400mg|Patients will be randomized to either received perioperative indomethacin or ibuprofen at the time of their emergent cerclage placement for 24 hours following surgery. Patient will be followed up through our electronic medical record system to determine gestational latency to evaluate if ibuprofen is inferior to indomethacin.
15766275|NCT04726072|Behavioral|Kundalini Yoga|Participants met once a week for two hours for 12 weeks total. The Kundalini yoga intervention is a mixture of basic yoga, breathing exercises, and meditation. Participants were also asked to do at-home practice for half an hour daily.
15766276|NCT04726072|Behavioral|Psychoeducation|Participants met once a week for two hours for 10 weeks total. The psychoeducation group acted as our control group and consisted of teaching participants about healthy aging. Participants were asked to do at-home practice for half an hour daily.
15766277|NCT04726059|Device|Transcutaneous Spinal Cord Stimulation|Therapeutic TCSCS will be delivered during ABT using an isolated bipolar constant current stimulator (Keypoint 4, Natus Medical Incorporated, USA). A biphasic rectangular waveform with 0.3 to 1.0-ms pulses, a carrier frequency of 10 kHz, administered at 5 to 40 Hz with a current ranging from 30 to 200 mA will be used.
15766278|NCT04726059|Device|SHAM (low-intensity) Transcutaneous Spinal Cord Stimulation|Ineffective stimulation will be verified by the absence of lower extremity skeletal muscle activation, determined by electromyography, and administered at the same anatomical location as therapeutic TCSCS.
15766279|NCT04726059|Device|Activity-Based Therapy|"Using the Lokomat exoskeleton by Hocoma, all participants (both arms) will train 3 times per week for 12 weeks with a target to reach 20 minutes of balance training and 30 minutes of gait training in each session.
~For balance training, participants will be asked to attempt to stand to the best of their ability without relying on the Lokomat's structural support. Sensors built into the Lokomat will capture pressure the participant is applying to the joints and provide visual feedback for how much they are relying on the device for support. Will be done in 5-minute bouts with 1-minute rest inbetween.
~For gait training, the Lokomat will provide participants with the complete walking assistance, but level of body weight support and speed of walking will be adjusted to allow the person to bear as much weight as possible while maintaining proper stance limb kinematics."
15766280|NCT04726046|Drug|Cefotetan|Cefotetan (as Disodium) 1 GM Injection before surgery
15766281|NCT04726033|Drug|64Cu-DOTA-TLX592|TLX592, a humanised, engineered monoclonal antibody HuX592r conjugated with a DOTA chelator and radiolabelled with 64Cu (64Cu-TLX592)
15766282|NCT04726020|Other|Intensive monitoring|periodic and planned monitoring nurse intervention with phone call
15766283|NCT04726020|Other|Standard monitoring|standard monitoring of adverse event reaction
15766284|NCT04726007|Drug|Antithrombotic Agents|Antithrombotic agents include anticoagulants, antiplatelet drugs, thrombolytic drugs.
15766285|NCT04725994|Drug|IDX-1197+XELOX|The dose levels will be escalated following a 3+3 dose escalation scheme.
15766286|NCT04725994|Drug|IDX-1197+Irinotecan|The dose levels will be escalated following a 3+3 dose escalation scheme.
15766287|NCT04725981|Procedure|Total laparoscopic hysterectomy|Control group: colpotomy closure technique: 3 Z-sutures PDS 0 Intervention group: colpotomy closure technique: 3 Z sutures with PDS 0 and 1 continuous suture with V-Loc 2-0
15766288|NCT04725968|Procedure|Urgent major general surgery|All geriatric patients (75 years and over) going under urgent major general surgery during 2018 in our centre
15766289|NCT04725955|Other|Enriched wheat bread|Either 50g of glucose dissolved in 250mL water or wheat bread enriched with 5mg a-cyclodextrin or wheat bread enriched with a 5mg mixture of a-cyclodextrin and encapsulated hydroxytyrosol (per 50g of available carbohydrates).
15766290|NCT04725942|Drug|Oral Posaconazole tablets|Posaconazole tablets (300 mg Q12h D1) taken orally on the day of transplantation, and followed by 300mg Qd, until 90 days after transplantation.
15766291|NCT04725916|Other|Showering|Patients will be instructed to shower after surgery with drains in place
15766292|NCT04725916|Other|Restriction of Showering|Patients will be restricted from showering post operatively if they have drains in place
15766293|NCT04725903|Radiation|High-Dose Rate Brachytherapy|Receive high-dose rate brachytherapy boost
15766294|NCT04725903|Radiation|Proton Beam Radiation Therapy|Undergo proton beam therapy
15766295|NCT04725903|Other|Quality-of-Life Assessment|Ancillary studies
15766296|NCT04725903|Other|Survey Administration|Ancillary studies
15766297|NCT04725890|Device|The DyaMX Device|The DyaMX device is designed to induce duodenal mucosal regeneration using pulsed electric field. The DyaMX procedure is a non-surgical, endoscopic procedure.
15766298|NCT04725877|Biological|VIR-1111|VIR-1111 is administered as a 1 mL subcutaneous injection in the deltoid area of the upper arm on Day 1 and Day 57.
15766299|NCT04725877|Drug|Placebo|A placebo (Tris NaCl Sucrose formulation buffer) given by subcutaneous injection.
15766301|NCT04725851|Procedure|High concentration Oxygen therapy|FiO2 >80% Oxygen (Delivered with 12-15L/min Non-rebreather Mask)
15766302|NCT04725851|Procedure|Control: Room Air or Low concentration Oxygen|FiO2 <30% Oxygen (Delivered with 0-2L/min Nasal Cannula)
15766303|NCT04725838|Device|Medtronic Intellis™|Differential Target Multiplexed (DTM®) programming using Medtronic Intellis™ Spinal Cord Stimulation system
15766304|NCT04725825|Other|Dry needling|Dry needling (DN) is a myofascial treatment technique, in which a thin, solid filiform needle is inserted directly into the MTrP. During dry needling, local twitch responses (LTR) can be elicited. These are involuntary contractions of muscle fibers, leading to muscle relaxation, an increase in blood flow,recovery of the muscle metabolism and thus a reduction of pain and stiffness.
15766305|NCT04725825|Other|Sham needling|During sham needling, a solid, filiform needle is inserted in the skin surface at the trigger point location, without penetrating the fascia and muscle tissue.
15766306|NCT04725812|Drug|Eculizumab|Eculizumab Intravenous Solution
15766307|NCT04725786|Other|thoracic echography|The research intervention corresponds to the performance of a thoracic echography to diagnose an incipient pulmonary interstitial syndrome.
15766308|NCT04725773|Device|Deep brain stimulation effect on apraxia|We will evaluate the effect of DBS on apraxia
15766309|NCT04725760|Device|BrainPort Vision Pro|"Ten hours of training over 3 to 5 days, followed by autonomous use of the device.
~It will be recommended that the subject use the BrainPort® Vision Pro device for at least 5 hours per month for a period of 12 months."
15766310|NCT04725747|Drug|Midazolam/Ketamine HCl 3mg-50mg sublingual|Single sublingual administration of Midazolam/Ketamine HCl 3mg-50mg sublingually prior to surgery
15766311|NCT04725747|Drug|Midazolam 3mg Sublingual|Single sublingual administration of Midazolam 3mg sublingually prior to surgery
15766312|NCT04725747|Drug|Ketamine 50mg Sublingual|Single sublingual administration of Ketamine HCl 50mg sublingually prior to surgery
15766313|NCT04725734|Other|Pregnant women|The patients will complete a questionnaire for each quarter
15766316|NCT04725708|Procedure|procedure: cerebral oxygenation intervention|During the surgery, cerebral oxygenation will be followed and intervention will be made to pH, PaO2, PaCO2, mean arterial pressure, hematocrit when necessary. In addition perfusion flow was maintained at or close to between 2.2-2.5 L/min/m2 . Perfusion pressure was adjusted using a phenylephrine infusion to maintain a mean arterial pressure of 50 to 70 mm Hg.
15766317|NCT04725695|Drug|Viscous Lidocaine|The patients will be randomized to either viscous lidocaine or placebo
15766318|NCT04725682|Drug|Tacrolimus|a single dose of 1 mg capsule per period
15766319|NCT04725669|Diagnostic Test|ELISA IgG Testkit|All samples will be tested for IgG antibody level to pertussis toxin using a commercial Bordetella pertussis ELISA IgG Testkit in accordance to the manufacturers' protocol in the laboratory at the University Hospital for Infectious Diseases in Zagreb.
15766320|NCT04725656|Procedure|Smoking cessation counseling|Smoking cessation counseling at baseline, week 1, week 2 and week 4.
15766321|NCT04725656|Other|Open system vape device and nicotine salt e-liquids|Ad libitum use of nicotine salt e-liquids during three months.
15766322|NCT04725643|Device|Track bleeding patterns before and after implant|Participants will report if they had bleeding and the amount based on the Pictorial Blood Assessment Chart. Participants will also complete weekly surveys regarding their satisfaction with their bleeding. We will also ask participants to complete a survey regarding their satisfaction with their bleeding at end of month 2 and at the end of month 3 after replacement of their contraceptive implant.
15766323|NCT04725630|Behavioral|Healthy food subsidy|$1.50/day/household member for 6 months to purchase healthy foods in participating supermarkets.
15766324|NCT04725630|Behavioral|Healthy food prescription|A one-time healthy food prescription pamphlet
15766325|NCT04725617|Drug|Varenicline|Standard smoking cessation treatment.
15766326|NCT04725617|Behavioral|Smoking Cessation Counseling|Standard smoking cessation treatment
15766327|NCT04725617|Behavioral|Health Approach 1 to Reduce Smoking|Behavioral health intervention option 1
15766328|NCT04725617|Other|Health Approach 2 to Reduce Smoking|Behavioral health intervention option 2
15766329|NCT04725604|Device|pH probe|"Patients who agree to take part will have a pH probe inserted into their injured limb. The pH probe will be attached to a pH monitor which will record pH data for up to a maximum of 72 hours (24 hours per probe). The surgical team will not have access to the pH data. During the time they are considered at risk for ACS, patients will be monitored in the routine way (using regular clinical assessment and pressure monitoring). If ACS is diagnosed in the routine way, then treatment (fasciotomy) will be offered as appropriate."
15766330|NCT04725591|Device|Dexcom G6 Continuous Glucose Monitoring|Collection of glucose data
15766331|NCT04725591|Device|Kaleïdo External Insulin Pump|Insulin delivery
15766332|NCT04725591|Device|Diabeloop Software (Model predictive control)|Diabeloop software embeds a regulation algorithm to automatically regulate the patient's glycaemia. It takes as input glycaemia value received every 5 minutes from the CGM and patient inputs related to meals and physical activities and it calculates the amount of insulin to be delivered. It sends this information to the pump that automatically delivers this quantity.
15766333|NCT04725591|Other|Declaration of meals|Patient inputs related to meals
15766334|NCT04725591|Other|No declaration of meals|No patient inputs related to meals
15766335|NCT04725591|Other|Remote monitoring (Telemedicine)|Remote follow up by care health providers team
15766336|NCT04725578|Behavioral|Telehealth Single Session Consultation|A remotely delivered, single, goal-directed consultation session based on Solution-Focused Brief Therapy (SFBT). SFBT is an evidence-based therapy approach that is primarily focused on the client's present problems and their immediate future. When using SFBT in a single-session the aim of the intervention becomes empowering the client to take the smallest possible steps towards their desired future.
15766337|NCT04725565|Behavioral|Genetics ADvISER Decision Aid Plus Standard Genetic Counselling|The decision aid will educate patients about the types of incidental finding they can learn from genomic sequencing and will give them opportunity select what types of results they would like to receive.
15766338|NCT04725565|Behavioral|Standard Genetic Counseling|Standard Genetic counseling to learn about and select incidental results from genomic sequencing.
15766339|NCT04725552|Behavioral|'Change' - an e-health intervention|The aim of the e-health intervention is to support the patient's change process and facilitate the doctor's ability to help. We plan for a web-application instead of a native application. A web-application enables use from mobile devices and from computers and is thus not dependent on a specific mode or system. Before including patients (postponed to September 2020 because of the Corona-virus pandemic), about 30 members of the general public have tested the e-health intervention.
15766340|NCT04725539|Procedure|hypoxic exposure|"Administration of different hypoxic doses.
~Intermittent hypoxia:
~days 1-5 duration of breathing periods 5*3min (FiO2 14-21%) days 8-12 duration of breathing periods 4*4min (FiO2 = 12%) and 3*3 min (FiO2 = 21%) days 15-19 duration of breathing periods 5*5min (FiO2 = 10%) and 4*3 min (FiO2 = 21%)
~one night at 1900m"
15766341|NCT04725526|Device|Mobile phone compatible with iOS or Android|MHealth (mobile health) intervention is an act whose purpose is to improve, maintain, promote or modify health, functioning or health conditions.
15766342|NCT04725513|Device|Shockwave Therapy|Participants will receive shockwave therapy once a week for three weeks
15766343|NCT04725513|Device|Photobiomodulation Therapy|Participants will receive photobiomodulation therapy twice a week for three weeks
15766344|NCT04725513|Other|Physical Therapy|Participants will enroll in physical therapy and complete an at-home exercise protocol
15766345|NCT04725500|Device|Auto-Titrating EPAP|In the Auto-titrating EPAP mode, the device automatically adjusted EPAP to the minimum level able to abolish tidal expiratory flow limitation.
15766346|NCT04725487|Other|Standard integration program with social and health promoting intervention|"Basic language course, internships, courses in Labour market knowledge and Danish culture
~Physical activity workshops
~Community gardening (garden workshops)
~Entrepreneurship course
~MindSpring course
~Family excursions
~Danish language workshops"
15766347|NCT04725487|Other|Standard integration program|Standard integration program (basic language course, internships, courses in Labour market knowledge and Danish culture)
15766348|NCT04725474|Biological|CTL-002|monoclonal antibody
15766349|NCT04725461|Device|Low cost lower limb prosthetic socket|"A pre-made 3D printed cylinder used as an outer shell is selected for each subject based on their measurements. The space between the residual limb and the outer shell will be filled with an expanding polyurethane foam (Foam IT 8, Smooth On Inc.) that conforms to the residual limb and bonds with the outer shell to form a strong and lightweight socket. The foam forms a smooth surface against the protective sheath; the socket is fully formed once the foam has hardened to the 3D printed cylinder.
~A prefabricated supracondylar suspension cuff made of Dacron or nylon, or a commercially available suspension sleeve may be will be applied to the prosthetic socket to aid in suspension. Commercially available components, including the International Committee of the Red Cross (ICRC) transtibial polypropylene component system will be attached to the bottom of the socket to allow the patient to ambulate in the prosthesis."
15766350|NCT04725448|Drug|Toripalimab|240mg, ivgtt, d1, every 3 weeks until disease progress or intolerable toxicity, up to 2 years of administration
15766351|NCT04725448|Drug|Bevacizumab|7.5mg/kg, ivgtt, d1, every 3 weeks, up to 2 years of administration
15766352|NCT04725448|Drug|Nab-paclitaxel|260mg/m2,d1 or 130mg/m2,d1,8, ivgtt, every 3 weeks, up to 6 cycles
15766353|NCT04725448|Drug|Carboplatin|AUC=4～5, d1, ivgtt, every 3 weeks, up to 6 cycles
15766354|NCT04725435|Behavioral|Kangaroo care|Experimental: Kangaroo care The mother kangaroo will care for at least 60 minutes.
15766355|NCT04725435|Behavioral|Facilitated Tucking Position|"Experimental 1: Manual Facilitated Tucking Position, infants will be given a manual facilitated tucking position during the heel stick procedure.
~Experimental 2: Facilitated Tucking Position with the Nesting Bed (Tortoise Neo Bed), the facilitated tucking position will be given by the clinic nurse with the nesting bed during the heel stick collection procedure."
15766356|NCT04725422|Drug|Methotrexate|second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs
15766357|NCT04725422|Drug|Sulfasalazine|second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs
15766358|NCT04725422|Drug|Leflunomide|second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs
15766359|NCT04725422|Drug|Pamidronate|second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs
15766360|NCT04725422|Drug|Zoledronic acid|second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs
15766361|NCT04725422|Drug|Etanercept|second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs
15766362|NCT04725422|Drug|Adalimumab|second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs
15766363|NCT04725422|Drug|Certolizumab|second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs
15766364|NCT04725422|Drug|Infliximab|second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs
15766365|NCT04725422|Drug|Golimumab|second-line treatment for children with CNO/CRMO after failure to respond to NSAIDs
15766366|NCT04725396|Device|Mandibular Reconstruction (MR) with Preoperative Virtual Planning (PVP).|PVP-assisted mandibular reconstruction includes the production of the surgical cutting guides required for mandibular resection and fibula free-flap conformation and of the preformed plates for flap osteosynthesis (for all patients, PVP will be done by the same laboratory).
15766367|NCT04725396|Device|Conventional Mandibular Reconstruction (MR without PVP)|Conventional Mandibular Reconstruction
15766368|NCT04725383|Drug|amitriptyline|Amitriptyline is a tricyclic antidepressant being studied off-label here for repetitive behaviors in autism spectrum disorders.
15766369|NCT04725370|Other|NA - survey instrument|Survey instrument was administered verbally to parents of the Guatemalan cohort.
15766370|NCT04725357|Drug|Meloxicam 15 mg|Participants will receive a prescription of 20 pills of 15 mg Meloxicam after surgery
15766371|NCT04725357|Procedure|Preoperative Interscalene Nerve Block|Preoperatively participants will standardly receive an interscalene nerve block
15766372|NCT04725357|Procedure|arthroscopic labral repair|participant will have their standard surgical procedure done
15766373|NCT04725344|Other|ACTIV'DOS group|ACTIV'DOS group use ACTIV'DOS application (with smartphone) to do the self rehabilitation each day (15 minutes per day) during 6 weeks. There are 7 exercices.
15766374|NCT04725344|Other|Usual practise|Control group uses a standard sheet of paper to do the self-rehabilitation (15 minutes per day) during 6 weeks. There are 7 exercises.
15766377|NCT04725318|Other|One-lung ventilation|One-lung ventilation as part of routine clinical care for patients undergoing thoracic surgery under general anesthesia
15766378|NCT04725305|Device|BiZact|It has been described as describes a bipolar device that continuously measures impedance of clamped tissue, adjusting energy levels in real time and automatically stopping energy delivery when a seal is established. Their literature suggests the device permanently seals vessels up to 3mm with less thermal damage, resulting in less intraoperative blood loss, more efficient procedures, and possibly less pain
15766379|NCT04725305|Procedure|Standard of care|This method would involve removal of tonsils using electrocautery technique
15766380|NCT04725279|Procedure|Rehabilitation Treatment: Physiotherapy, Electrotherapy or Exercises at home|The 67 patients attended the rehabilitation consultation where, after taking the anamnesis, they began to perform balance tests with a stabilometric platform and those patients with associated neck pain, with cervical motion sensors. Treatment with conventional physiotherapy, electrotherapy or exercises at home was prescribed as appropriate to each one. 3 months later, the patients were examined again in consultation, using a new anamnesis, the platform and the sensors.
15766381|NCT04725266|Behavioral|Family-based intervention|The intervention aims to motivate drug abusers to stay drug abstinence and improve family functioning with the support of their own families. In the component of engagement, we will use effective and appropriate skills to engage clients, understand their concerns, and provide necessary resources to them. In the component of role identification, we will help drug abusers identify their family roles through providing education on family roles and responsibilities. The component of affection is designed to learn affective responsiveness and enhance their emotional bonds with each other, while in the component of competence, we will enhance their competency to take care of the family. The intervention will be conducted in group sessions with 4-6 families per group. A total of 10 sessions will be delivered with 1.5-2 hour for each session (3 sessions for role identification, 4 sessions for affection, and 3 sessions for competence).
15766382|NCT04725266|Other|routine care|Routine care includes individual-session components of engagement, case assessment, drug education, service referral, family support, and etc.
15766383|NCT04725253|Dietary Supplement|Nicotinamide|Nicotinamide, 1,5 gr per day for 7 days.
15766384|NCT04725253|Other|Placebo tablets|Placebo tablets, 1 per day for 7 days.
15766385|NCT04725240|Drug|Setmelanotide|"Subjects aged 6 to <16 years, inclusive
~Starting at Baseline (Day 1; Visit 2) through approximately Day 14, subjects will receive setmelanotide 1.0 mg/day.
~Starting at approximately Day 15 through 28, subjects will receive setmelanotide 2.0 mg/day.
~Subjects/caregivers will be contacted by study center personnel on Day 15 to ensure dose titration has occurred and to document any adverse events (AEs).
~• Starting on approximately Day 29 (Visit 3), subjects will receive setmelanotide 3.0 mg/day; subjects will continue to receive setmelanotide 3.0 mg/day for 12 weeks.
~The dose of setmelanotide should be titrated as explained in the SoA. Subjects aged ≥16 years, inclusive
~Starting at Baseline (Day 1; Visit 2) through approximately Day 14, subjects will receive setmelanotide 2.0 mg/day.
~Starting at approximately Day 15, subjects will receive setmelanotide 3.0 mg/day; subjects will continue to receive setmelanotide 3.0 mg/day for 14 weeks."
15766386|NCT04725214|Drug|Anlotinib|Anlotinib With STUPP Regimen
15766387|NCT04725201|Drug|Intravenous unfractionated heparin|See experimental arm description for intervention description.
15766388|NCT04725201|Drug|Sham|See sham comparator arm description for intervention description.
15766392|NCT04725175|Drug|PIPE-307|Single and multiple ascending oral doses of PIPE-307 tablets
15766393|NCT04725175|Drug|Placebo oral tablet|Single and multiple ascending oral doses of matching Placebo tablets
15766394|NCT04725162|Radiation|18F-FDG|All subjects received 18F-FDG PET examination.
15766395|NCT04725149|Other|500 ml base solution|Color, taste, aroma, and calorie matched water base
15766396|NCT04725149|Other|500 ml containing 30 ml tart cherry concentrate diluted with water and base solution|Montmorency cherry concentrate
15766397|NCT04725149|Other|500 ml containing 60 ml tart cherry concentrate diluted with water only|Montmorency cherry concentrate
15766398|NCT04725136|Biological|FURESTEM-AD inj|Repeated administration group: 3 times high or low dose at 4 week intervals. Single administration group: 1 time high or low dose, 2 times placebo injection at 4 week intervals Placebo: 3 times placebo injection at 4 week intervals.
15766399|NCT04725123|Diagnostic Test|Microbiome analysis|Stool microbiome analysis of 16S rRNA sequencing to an anticipated number of 8,000,000 reads
15766400|NCT04725110|Drug|Instilled T3|The first dose of T3 (50 micrograms in 10 mls volume BID) will be instilled by an investigator or under their direct supervision within 48 hours of obtaining consent after verifying that the patient is not too unstable to treat at that time. T3 doses will be given in 50 mcg doses twice daily for 4 days.
15766401|NCT04725110|Other|Placebo Therapy|A placebo therapy will be instilled into the lungs by the investigator or under their direct supervision within 48 hours of obtaining consent after verifying that the patient is not too unstable to treat at that time. Doses will be given twice daily for 4 days.
15766402|NCT04725084|Other|Use of High Flow Nasal Cannula alone|Use of high flow nasal cannula oxygen therapy alone
15766403|NCT04725084|Other|Use of Non-invasive Ventilation|Use of non-invasive ventilation combined or not with high flow nasal cannula oxygen therapy
15766404|NCT04725084|Other|Use of Continuous Positive Airway Pressure|Use of continuous positive airway pressure combined or not with high flow nasal cannula oxygen therapy
15766407|NCT04725058|Other|Medical Group Visit|A group of 20 or more participants will receive obesity management through endocrinologist and registered dietitian.
15766408|NCT04725058|Other|Dietitian Individual Visit|Participant receives obesity management individually from a registered dietitian.
15766409|NCT04725045|Device|Boston Scientific: Study tool computer|compare clinical outcome measurements of complex pulse shapes to standard clinical pulse shape
15766410|NCT04725032|Drug|Propofol|Propofol will be administered for anesthesia maintenance in patients randomized to the propofol-based TIVA arm of the study. In order to record the VEPs, standard spiral electrodes or subcutaneous electrodes will be inserted subcutaneously around the visual area and the Nicolet Viking IV System will be used to monitor VEP during surgery.
15766411|NCT04725032|Drug|Sevoflurane|Balanced general anesthesia with sevoflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study. In order to record the VEPs, standard spiral electrodes or subcutaneous electrodes will be inserted subcutaneously around the visual area and the Nicolet Viking IV System will be used to monitor VEP during surgery.
15766412|NCT04725019|Device|active transcranial direct current stimulation|Participants will receive 20 min of tDCS over the scalp during 20 min of motor training.
15766413|NCT04725019|Behavioral|Motor training|Participants will engage in a high number of repetition of movements that use both hands while playing with toys and games. Training will be provided 20 min/day, for 5 consecutive days.
15766414|NCT04725006|Device|Spinal cord stimulation system|These systems are indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain and leg pain. Stimulation will be applied to the system using an external stimulator to see if sensations can be evoked in the participant's limb/foot.
15766415|NCT04724993|Other|Online Aerobic Dance Exercises|Online aerobic dance exercises will be performed with observance of physiotherapist. They will record their daily physical activity.
15766416|NCT04724993|Other|Physical Activity Counseling|Physical activity and exercise will ve explained to the participants.And they will record their daily physical activity.
15766417|NCT04724980|Drug|PRGN-2012|This is a phase I, 3+3 dose escalation clinical trial evaluating PRGN-2012 at two dose levels (1x10^11 and 5x10^11 particle units (PU)) administered as adjuvant therapy prior to standard-of-care debulking surgery.
15766418|NCT04724967|Drug|CeraVe Hydrating Cleanser|topical cleanser applied twice a day for 28 days
15766419|NCT04724967|Drug|CeraVe Moisturizing Cream|topical cream applied twice a day for 28 days
15766420|NCT04724954|Device|Rehabilitation Therapy on Experimental Robotic Table and standard of care|Experimental group will receive VR game-based rehabilitation therapy through Bright Cloud's proprietary device, called BrightArm Compact (BAC). They will also receive Standard of Care rehabilitation
15766421|NCT04724954|Genetic|Rehabilitation Therapy as part of Standard of Care (Control)|Control group will receive Standard of Care training only
15766422|NCT04724941|Other|No intervention|No intervention
15766423|NCT04724928|Radiation|metastasis directed therapy (MDT)|MDT in case of oligometastases
15766424|NCT04724928|Drug|Immunotherapy|immunotherapy in the setting of polymetastatic disease
15766425|NCT04724915|Procedure|Conventional Total Knee Arthroplasty|People will undergo surgery to replace the knee joint with a prosthesis in case of osteoarthritis. This will be performed with manual instrumentarium (jig-based).
15766426|NCT04724915|Procedure|Robot-Assisted Total Knee Arthroplasty|People will undergo surgery to replace the knee joint with a prosthesis in case of osteoarthritis. This will be performed with the help of a surgical robot.
15766448|NCT04724681|Device|WARD CSS|Wireless devices monitor vital signs continuously and transmit real-time data to an app that notifies clinical personnel when relevant deviations in vital signs occur This group will be monitored with standard Early Warning Score as well
15766427|NCT04724902|Other|Elastic bandage compression|The compression will be applied with the volunteer in the supine position on a stretcher, with both lower limbs extended and relaxed. The intervention in the Compression group will be with elastic bandages involving the entire surface of the knee, positioned considering anatomical aspects: femoral condyles and the anterior tibial tuberosity. The level of compression must be maintained between 30 mmHg and 60 mmHg, according to the researched literature. The variations within these values will be stipulated according to the volunteer's self-report (comfortable and painless compression). The Shan Group will have the bandage wrapped around the knee without any compression force being exerted. The intervention will be carried out for 20 minutes, once a day, for 4 consecutive days. The Control group will be composed of volunteers who make up a study waiting list and will carry out the evaluations at the same time intervals as the other groups, but will not receive any type of intervention.
15766428|NCT04724889|Diagnostic Test|blood test|Blood test to check high sensitivity troponin. Additional blood biomarkers maybe added in light of new research
15766429|NCT04724863|Procedure|Angioscan|"The study procedure foresees to take images during a deep breath as well as deep exhalation. This second measurement does not require the administration of an additional amount of contrast material. However, the exposure time to ionising radiation is doubled. The examination uses helical acquisition in fast mode. The duration of the helix is of the order of 2 seconds in the inspiration phase, then there is a delay of 5 seconds of machine time (half-turn) and again 2 seconds of exposure in the expiration phase, i.e. 4 seconds of actual exposure to ionizing radiation, the time of image taking and 9 seconds the total time of the examination."
15766430|NCT04724837|Drug|Zibotentan|Participants will receive zibotentan as per the arms they are randomized.
15766431|NCT04724837|Drug|Dapagliflozin|Participants will receive dapagliflozin as per the arms they are randomized.
15766432|NCT04724837|Drug|Placebo|Participants will receive placebo matched to zibotentan or dapagliflozin.
15766433|NCT04724824|Device|Brain-Computer Interface|Passive hand movement will be provided to patients' paralyzed hand by means of a robotic hand orthosis that will be activated by the brain-computer interface based on hand movement intention.
15766434|NCT04724824|Device|Sham Brain-Computer Interface|Passive hand movement will be provided to patients' paralyzed hand by means of a robotic hand orthosis which activation will be independent of the output of the brain-computer interface based on hand movement intention.
15766435|NCT04724811|Procedure|Open reduction and internal fixation (ORIF)|"Approaches used:
~Intrapelvic approach +/- iliac window
~Kocher-Langenbeck approach"
15766436|NCT04724785|Other|only monitoring|monitoring the viraemia only
15766437|NCT04724785|Other|monitoring and regimen change if necessary|if those patients agree, the regimen will be changed.
15766438|NCT04724785|Drug|regimen change|Based on ongoing one, regimen will be changed . The principle for adjusting anti-viral regimen is as follows: 1. The patients were treated with second-line drugs: changing ADV to ETV/TAF/TDF , changing LAM to TAF/TDF and changing LdT to TAF/TDF; 2. The patients were treated with ETV: adding or switching to TAF/TDF;3. TAF or ETV is recommended for patients with one or more TDF risk factors, such as > 40 years old, patients with abnormal bone/kidney related indicators or patients with high risk of bone/kidney injuries.【ADV=adefovir dipivoxil, LAM=lamivudine, and LdT=telbivudine , TAF =Tenofovir alafenamide Fumarate, ETV=Entecavir and TDF=Tenofovir disoproxil fumarate 】
15766439|NCT04724772|Drug|Tranexamic acid injection|Injection of tranexamic acid preoperatively
15766440|NCT04724759|Drug|Dexmedetomidine / Ketamine / Lidocaine|Patients in this group will receive an infusion of lidocaine, ketamine, or dexmedetomidine supplemented with other intravenous analgesics and intravenous and inhaled anesthetics, as needed clinically. This includes administration of 5 mcg/kg/min of ketamine plus 0.5 - 1.0 µg/kg/hr of dexmedetomidine (Precedex) as a continuous infusion, started from induction to stop one hour before surgery is anticipated to end.
15766441|NCT04724746|Behavioral|Written Exposure and Cognitive Behavioral Therapy|Intervention involves writing details about a recent sexual assault and coping skills for substance use.
15766442|NCT04724733|Behavioral|Smoke Sense|Smoke Sense is a smartphone application (app). Smoke Sense participants will be asked to establish a profile which includes demographics, baseline health information and current beliefs about smoke and air pollution. In the Symptoms & Smoke Observations tab, participants are asked to report their weekly observations of smoke, health symptoms, and exposure reduction behaviors. In the Fire & Smoke Near Me tab, participants review the most recent AQ data measured at an AQ monitoring sites. Participants are asked to complete the AQ 101 module which test knowledge of AQ facts and provides correct answers. Badges are awarded for accomplishments within the app to promote certain desired behaviors: completing a user profile, launching the app weekly to check local AQ, reporting smoke and symptom observations, expanding AQ knowledge with AQ lessons, and exploring the map. Finally, participants can engage with other users by viewing cumulative statistics of symptoms and smoke observations.
15766443|NCT04724733|Behavioral|Smoke Sense Plus|Participants randomized to the Smoke Sense Plus intervention will be asked to do everything that the Smoke Sense intervention group does on a weekly basis, as well as: 1) Receive weekly push notifications that remind them to, for example, review their asthma action plan, refill any expired medications, take their daily controller medication, identify a clean air space in their home and community, 2) Monitor their lung function weekly via mobile spirometry, and 3) Subscribe to a social network to share strategies to minimize exposure.
15766444|NCT04724720|Drug|Famotidine|Standard or care treatment plus prescribed famotidine
15766445|NCT04724720|Drug|Placebo|Standard of care treatment plus placebo
15766446|NCT04724694|Behavioral|Brief CBT for Chronic Pain|Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6-12 weeks. Session one focuses on foundational pain education and the development of treatment goals. Session two emphasizes balanced engagement in physical activity and pleasurable events. Session three emphasizes skills training for easily implemented relaxation techniques. Sessions four and five focus on recognizing and modifying unhelpful thoughts that negatively impact pain. Session six focuses on relapse prevention and independent implementation of CBT-CP skills following treatment.
15766447|NCT04724694|Other|Treatment as usual|Participants assigned to TAU will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated.
15766449|NCT04724668|Dietary Supplement|Melatonin (3hrs before DLMO)|Melatonin 3mg (3hrs before DLMO)
15766450|NCT04724668|Dietary Supplement|Placebo (3hrs before DLMO)|Placebo capsule (3hrs before DLMO)
15766451|NCT04724668|Device|Morning light version 1|Morning light version
15766452|NCT04724668|Device|Morning light version 2|Morning light version
15766453|NCT04724655|Other|gastric lavage with paraffin oil and bicarbonate|Gastric lavage will be initiated with 50 mL of Paraffin oil and 50 mL of sodium bicarbonate solution 8.4%, then aspiration will be done after 3-5 min through nasogastric tube
15766454|NCT04724655|Other|gastric lavage with coconut oil and bicarbonate|Gastric lavage will be initiated with 50 ml coconut oil and 50 ml sodium bicarbonate 8.4 % then aspiration will be done after 3-5 min through nasogastric tube
15766455|NCT04724655|Drug|standard treatment|inotropes as levophid, fluids and electrolytes , endotracheal intubation, mechanical ventilation and antiarrhythmic agents as Magnesium sulfate
15766456|NCT04724655|Other|gastric lavage with saline and bicarbonate|Gastric lavage with saline and sodium bicarbonate 8.4% then aspiration will be done after 3-5 min through nasogastric tube
15766457|NCT04724629|Biological|Ixekizumab|80 mg of IL-17 inhibitor
15766458|NCT04724629|Biological|Aldesleukin|1.5 million IU (low-dose) of IL-2
15766459|NCT04724629|Drug|Colchicine|0.5 mg of indirect IL-6 inhibitor
15766460|NCT04724629|Drug|Standard of care (SOC)|Active comparator (Corticoids and antiretrovirals)
15766461|NCT04724616|Other|Educational Program (CARTOON)|CARTOON is an interdisciplinary psychoeducational intervention program. It consists of five teaching sessions: 1) hand hygiene, not grasping the face, 2) sneezing etiquette, 3) wearing a mask, 4) social distancing, and 5) theoretical knowledge about the coronavirus. Using special exercises and games, information about the coronavirus is conveyed in a child friendly manner.
15766462|NCT04724603|Other|patients having had avderse event after phagotherapy for bone or joint or implant infection|to determine the accountability of adverse effects in having had avderse event after phagotherapy for bone or joint or implant infection
15766463|NCT04724590|Radiation|IMRT(IMAGE GUIDED INTENSITY-MODULATED RADIATION THERAPY )|Evaluation the optic neuropathy in nasopharynx cancer patients treated in our clinic.
15766464|NCT04724577|Radiation|carbon ion radiotherapy|dose escalation radiotherapy with five levels of dose from 54GyE/12Fx to 58.8GyE/12Fx
15766465|NCT04724564|Diagnostic Test|THE SURGICAL PLETH INDEX|CORRELATION OF DIFFERENT TIME MEASUREMENTS OF THE SURGICAL PLETH INDEX WITH POSTOPERATIVE PAIN
15766466|NCT04724551|Procedure|pancreatoduodenectomy (PD)|A pancreaticogastrostomy or -jejunostomy duct-to-mucosa was achieved according to the surgeon's preference and pancreatic texture.
15766467|NCT04724538|Radiation|99mTc-pertechnetate aerosol|99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol
15766468|NCT04724538|Drug|99mTc-pertechnetate aerosol|99mTc-pertechnetate is 99mTc-labeled carbon ultrafine aerosol
15766469|NCT04724525|Other|soft contact lens Toric|soft contact lens toric with different axis and power that use in human's eye
15766470|NCT04724512|Device|suture|a type of suture used in entropion surgery
15766471|NCT04724499|Behavioral|High-Intensity Intervals Training|16 week exercise program with stationary bike.
15766472|NCT04724499|Other|Attention Control|16 week stretching program.
15766473|NCT04724486|Drug|Triptorelin acetate|0.05-0.1 mg subcutaneously (SC) once daily from the mid-luteal phase (day 21) of the cycle until the day of ovulation triggering.
15766474|NCT04724486|Drug|Cetrorelix|0.25 mg subcutaneously (SC) once daily starting from the day detecting a leading follicle diameter ≥ 14 mm until the day of ovulation triggering.
15766475|NCT04724486|Drug|recombinant-FSH or recombinant-FSH + human Menopausal Gonadotropin|Dosage adjustment according to the ovarian response.
15766476|NCT04724486|Drug|Human Chorionic Gonadotropin (hCG)|Ovulation will be triggered by the administration of 10,000 IU of human chorionic gonadotropin when at least three follicles become more than 16-17 mm.
15766477|NCT04724473|Drug|Tretinoin Cream 0.025%|The study medication will be self-applied topically on the affected areas of the face lightly, once daily at bedtime, avoiding contact with the mouth, eyes, and other mucous membranes for 84 consecutive days.
15766478|NCT04724460|Drug|Long DOAC|Administration of Rivaroxaban for 18 months
15766479|NCT04724460|Drug|Short DOAC|Administration of Rivaroxaban for 6 months
15766480|NCT04724447|Drug|Valganciclovir|2 x 450mg VGCV tablets
15766481|NCT04724447|Drug|Placebo|Placebo equivalent of 900mg/day VGCV
15766482|NCT04724421|Drug|Voxelotor|synthetic small molecule
15766483|NCT04724408|Device|VieScope|see above
15766484|NCT04724408|Device|Conventional|see above
15766485|NCT04724395|Other|Hospitalization|Hospitalization in intensive care and non-intensive care units for COVID-19 followed by usual care
15766486|NCT04724382|Behavioral|Culturally tailored healthy eating advice|Culturally-tailored education includes strategies for healthy eating, preferences for traditional healthy foods, recommendations for limiting unhealthy traditional foods, portion sizes, etc.
15766487|NCT04724382|Behavioral|Standard healthy eating advice|Standard healthy eating education includes strategies, foods, portions, and cooking and eating tips for general dietary recommendations
15766488|NCT04724369|Drug|18F-MFBG|Positron-emitting tomography (PET) (either PET/CT or PET/MR) imaging agent
15766489|NCT04724356|Other|Virtual Reality|Intervention was led once per day, five days a week, over 8 weeks.
15766490|NCT04724356|Other|Resistance Exercise|Intervention was led once per day, five days a week, over 8 weeks.
15766491|NCT04724343|Drug|Triptorelin acetate|0.05-0.1 mg subcutaneously (SC) once daily from the mid-luteal phase (day 21) of the cycle until the day of ovulation triggering.
15766492|NCT04724343|Drug|Cetrorelix|0.25 mg subcutaneously (SC) once daily starting from the day detecting a leading follicle diameter ≥ 14 mm until the day of ovulation triggering.
15766493|NCT04724343|Drug|recombinant-FSH or recombinant-FSH + human Menopausal Gonadotropin|Dosage adjustment according to the ovarian response.
15766494|NCT04724343|Drug|Human Chorionic Gonadotropin (hCG)|Ovulation will be triggered by the administration of 10,000 IU of Human Chorionic Gonadotropin (hCG) when at least three follicles become more than 16-17 mm.
15766495|NCT04724330|Behavioral|Healthy for Two/Healthy for You|~10 month (early pregnancy to 12 weeks postpartum), remotely-delivered, behavioral lifestyle intervention including health coach contacts (via phone, videoconference, and email/MyChart) and an interactive web-based platform.
15766496|NCT04724317|Procedure|Steroid Group|Ultrasound guided shoulder intra-articular steroid injection
15766497|NCT04724317|Procedure|Ozone Group|Ultrasound guided shoulder intra-articular Ozone injection
15766498|NCT04724317|Procedure|PRF Group|Ultrasound guided shoulder intra-articular pulsed radiofrequency application
15766499|NCT04724304|Diagnostic Test|Real-Time Myocardial Echocardiography (RTMPE)|Uses sound waves (ultrasound) to produce an images of the heart. During RTMPE a microbubble contrast agent is administered through an intravenous line (IV) to make the images of your heart clearer.
15766500|NCT04724304|Diagnostic Test|Magnetic resonance image (MRI)|Imaging that focuses on the heart or blood vessels to assess size and function of the heart's chambers, thickness and movement of the walls of the heart, and blood flow in the blood vessels.
15766502|NCT04724265|Biological|collection of sample of perilymphatic fluid during cochlear implantation|collection of sample of perilymphatic fluid during cochlear implantation and to analyse it with a CMV polymerised-chain-reaction to evaluate the involvement of CMV in hearing loss.
15766503|NCT04724252|Drug|Gabapentin|Determine if the peri and post operative use of gabapentin in children reduces the need for narcotics after surgery.
15766504|NCT04724252|Other|Placebo|Control Arm
15766505|NCT04724239|Drug|Sintilimab|200mg IV on Day 1 Q3W
15766506|NCT04724239|Drug|Chidamide|30mg PO BIW each 3-week cycle
15766507|NCT04724239|Drug|IBI305|7.5mg/kg IV on Day 1 Q3W
15766508|NCT04724226|Drug|Camrelizumab; Apatinib|"Cryoablation
~Drug: Camrelizumab and Apatinib Camrelizumab (200mg), iv, Q3W; Apatinib (250mg), po, QD"
15766509|NCT04724213|Other|Testing of reliability / validity of new questionnaire|Participants will answer new questionnaire and other, established, generic and chronic generic HrQol instruments
15766510|NCT04724200|Diagnostic Test|Echocardiogram|Echocardiography plays a crucial role in the diagnosis of HF; it is the standard of care imaging modality used to confirm the diagnosis, it permits real-time imaging of the heart and quantitative assessment of cardiac structure and function, crucial for diagnosis.
15766511|NCT04724187|Drug|Misoprostol|it is prostaglandin E1 .
15766512|NCT04724187|Drug|Oxytocin|it stimulates uterine contractions
15766513|NCT04724174|Procedure|pancreaticogastrostomy|Pancreaticogastrostomy technique was performed according to the precise description of Addeo et al.
15766514|NCT04724174|Procedure|pancreaticojejunostomy|Pancreaticojejunostomy technique was performed using the 5/0 polypropylene interrupted monofilament suture in a one-layered duct-to-mucosa end-to-side anastomosis (Cattell-Warren anastomosis).
15766515|NCT04724161|Diagnostic Test|ANC surveillance|Clinic-based testing of all pregnant women during antenatal care visits using national standards and commercially available malaria rapid diagnostic tests
15766516|NCT04724148|Drug|Fentanyl|To assess the accuracy of HVPG in TIPS after injecting a dose of 1~2 mg/kg fentanyl.
15766517|NCT04724135|Other|Survey|The first part will assess the sociodemographic variables and reproductive characteristics, and the second part contain the Menopause-Specific Quality of Life (MENQOL) questionnaire The 29 questions of the MENQOL are divided into four domains: vasomotor (items 1-3), psychosocial (items 4-10), physical (items 11-26), and sexual (items 27-29).
15766518|NCT04724122|Other|Observational / Assessment only|The results of this assessment will determine the needs for future interventions
15766519|NCT04724109|Drug|Equfina|Equfina oral tablets.
15766520|NCT04724096|Diagnostic Test|Oxygen Enhanced MRI scan|Dynamic MRI scanning switching from breathing room air to high concentration oxygen part way through the scan.
15766521|NCT04724083|Diagnostic Test|biomarkers|new diagnostic biomarkers
15766522|NCT04724070|Genetic|NGS, PDO/PDX establishment|Patients' tumor specimens will be collected for next generation sequencing, PDO/PDX establishment and tissue banking.
15766523|NCT04724057|Device|AutocathFFR|The MedHub Autocath FFR device is a software only medical device. The FFR is computed from several standard DICOM format 2D angiography images retrieved from the C-arm imaging system, which display the structure of the vessels. The MedHub AutocathFFR device software analyzes these images and automatically (without the need for user selection or markings) and computes and displays the FFR on the viewed blood vessel.
15766524|NCT04724044|Drug|Tablets|Oral tablets of similar appearance to active study drug
15766525|NCT04724044|Drug|Clarithromycin 500mg|Oral tablets of 500mg of clarithromycin
15766526|NCT04724031|Drug|PARP inhibitor|use at any line of treatment in patients with advanced ovarian cancer
15766527|NCT04724018|Drug|Sacituzumab Govitecan (SG)|Intravenous infusion
15766528|NCT04724018|Drug|Enfortumab vedotin-ejfv (EV)|Intravenous infusion
15766529|NCT04724005|Other|No drug|No drug used
15766530|NCT04723992|Other|retrospective analysis|The investigators retrospectively analyzed the outcome and possible prognostic factors in polytrauma patients.
15766531|NCT04723979|Drug|Eptacog alfa|Recombinant coagulation factor VII activated
15766532|NCT04723979|Other|Standard of care|Patients have been treated according to local routine clinical practice at the discretion of the treating physician.
15766533|NCT04723966|Dietary Supplement|TPN|Total parenteral nutrition
15766534|NCT04723953|Diagnostic Test|68Ga-FAPI PET/MRI|PET and MRI in patients with acute myocardiac infarction are simultaneously analyzed using hybrid PET/MRI device for monitoring myocardial fibrosis and function.
15766535|NCT04723940|Drug|Bactrim|Bactrim will be given for 6 weeks to treat joint infection
15766536|NCT04723940|Drug|Cefadroxil|Cefadroxil will be given for 6 weeks to treat joint infection
15766537|NCT04723940|Drug|Doxycycline Hcl|Doxycycline HCl will given for 6 weeks to treat joint infection
15766538|NCT04723940|Drug|Clindamycin|Clindamycin will given for 6 weeks to treat joint infection
15766539|NCT04723927|Other|Older adults|The data for motor function and gait pattern analysis was obtained.
15766540|NCT04723914|Biological|dual target CAR-T cell therapy|CD19/CD20 dual target CAR-T cell therapy
15766541|NCT04723901|Biological|Dual target CAR-T cell therapy|CD19/CD22 dual target CAR-T cell therapy
15766542|NCT04723888|Dietary Supplement|alpha-ketoglutarate|alpha-ketoglutarate supplements
15766543|NCT04723875|Drug|Paclitaxel or docetaxel + Cisplatin or carboplatin|Paclitaxel 135-175mg/m2 over 3 hours or docetaxel 70-75 mg/m2， 30min ＋ Cisplatin 75-80mg/m2 or carboplatin AUC = 5, repeat per 21 days.
15766544|NCT04723862|Drug|Spironolactone|Spironolactone is an androgen-receptor blocker commonly used (off-label) for hyperandrogenism. The spironolactone dose will be 50 mg taken orally twice daily (for two weeks before admission to the Clinical Research Unit).
15766545|NCT04723862|Drug|Placebo|Placebo contains only inert ingredients and is not expected to exert any direct physiological effects.
15766546|NCT04723849|Dietary Supplement|Auxilie® Immuplus, Envicon Medical, Verona, Italy|"Subjects took one tablet per day orally starting day one after the visit and continuing for the 6-month duration of the study. Height (cm) and weight (kg) were measured for each child at every visit. Endothelial function was assessed using two methodologies: a post occlusive release hyperemic test (PORH) and a heat provocation test (HPT)."
15766547|NCT04723836|Dietary Supplement|Riboflavin (5mg)|From 16th week gestation until end of pregnancy
15766548|NCT04723836|Dietary Supplement|5-methyltetrahydrofolate (400µg)|From 16th week gestation until end of pregnancy
15766549|NCT04723836|Dietary Supplement|Placebo|From 16th week gestation until end of pregnancy
15766550|NCT04723823|Other|Motor or sensory imagery|Brain activity will be measured using fMRI while participants imagine different movements or sensations in order to assess the organization of sensorimotor cortical activity after injury
15766551|NCT04723810|Drug|Indocyanine Green|The investigational drug is indocyanine green, single dose between 1-5 mg/kg diluted into sterile water for intravenous (IV) injection up to 5 days prior to resection surgery. The actual dose and timing from dose to imaging will be determined based on tumor type.
15766552|NCT04723797|Other|Physical activity|Physical activity program consisting of running and/or cycling
15766553|NCT04723784|Other|Initial Assessment|In this phase the evaluation of the participants will be done, with the application of the instrument presented in outcome measures' section. According to the age of the person, specific questionnaires will be used to gather information more concrete about the skills for mobility. This assessment will allow determining the specific needs, demands and capabilities of participants. The assessment process will be done by professionals of research groups in rooms of collaborators centers.
15766554|NCT04723784|Other|Implementation of assistive technology in the daily life of participants|The professionals of collaborator centers, supported by the research groups, will carry on the training in the use of AT by the participants, facilitating its incorporation during the performance of activities of daily living.
15766555|NCT04723784|Other|Application of outcome measures|After the process of implementation of AT (the next 2 and 6 months), members of the research group and the professionals of collaborators centers will apply the measurement instruments to determine the possible improvements in the level of functional independence (FIM scale) of people with disabilities, the impact that the AT has had on their lifes (PIADS scale) and the level of matching between person and AT (ATD PA - MPT model).
15766556|NCT04723758|Device|GI Genius-assisted diagnostic colonoscopy|Participants will undergo diagnostic colonoscopy, which will be identical to the normal standard of care at the unit where they are undergoing their procedure, except that GI Genius will be turned on during the procedure.
15766557|NCT04723758|Diagnostic Test|Diagnostic Colonoscopy|Diagnostic colonoscopy will be performed as per the standard of care for the unit where the patient is having their procedure.
15766558|NCT04723745|Behavioral|V-TRACTS Assessment/Feedback|The proposed V-TRACTS assessment strategically targets emotional, cognitive and behavioral functions that we have determined are highly predictive of long-term outcome in Veterans. The assessment targets domains of head injury, psychological trauma, depression, suicidality, anxiety, chronic pain and sleep, substance use and activity level. This assessment will, in most cases, be completed online using the Qualtrics platform and online using telehealth or other approved platform for the clinical interview. Once the assessment is complete, the clinical team will convene a consensus meeting to review the case and determine a course of recommended additional assessment and/or rehabilitation action. After a consensus is reached, a V-TRACTS psychologist/supervised fellow will provide comprehensive feedback encompassing the entire assessment battery and offer rehabilitation options that would be targeted to the individual veteran's needs via VA telehealth or other approved online service.
15766559|NCT04723745|Behavioral|OPTIONAL Brief Assessment of Thinking|A neuropsychological/cognitive assessment will be conducted to gather information about functioning in the areas of memory, attention, and thinking. This assessment is designed to be done online in a single session, and it will take approximately 45-90 minutes to complete. The test battery is designed to focus on the specific cognitive abilities thought to be impacted by blast, mTBI, PTSD, etc. This battery is not intended to be an exhaustive assessment of all neuropsychological functions.
15766560|NCT04723745|Behavioral|OPTIONAL STEP-Home-Brief|STEP-Home-Brief is a condensed version of the 12-week experimental program STEP-Home that will target four core skills (problem solving, emotional regulation, attention training, and health and wellness). It will be individualized to Veterans' problems: vocation/career, community reintegration, psychoeducation to destigmatize barriers to mental health, substance misuse, anger management, and family and intimate partner relationships. STEP-Home-Brief will include 1-3 sessions using the same treatment modules as the 12-week program in a condensed, targeted format.
15766561|NCT04723745|Behavioral|OPTIONAL At-home Exercise Program|This is a 5-week, full-body exercise program that can be done in the convenience of the Veteran's home, using only bodyweight as resistance and with household items as equipment. Given the online delivery of this program, they will receive access to instructional videos and materials that demonstrate how to perform each exercise safely and correctly. Participants will be contacted by study staff weekly over the phone to maintain interest and monitor adherence during the study.
15766562|NCT04723745|Behavioral|OPTIONAL Referral to 12-week STEP-Home|Referral to the experimental 12-week STEP-Home workshop research study (VABHS IRB #3210).
15766563|NCT04723745|Behavioral|OPTIONAL Clinical Referral|Clinical referrals to VABHS clinical services based on assessment and patient-directed primary problem/complaint.
15766564|NCT04723732|Drug|Myrrh mouthwash|1% mouthwash solution of commiphora myrrha, made from Commiphora Myrrha resin extract.
15766565|NCT04723732|Drug|Chlorhexidine mouthwash|0.2% mouthwash solution of chlorhexidine gluconate.
15766566|NCT04723732|Drug|Normal saline|0.9% solution of sodium chloride, containing 9 g/L Sodium Chloride (154 mEq/L sodium and 154 mEq/L chloride)
15766567|NCT04723719|Behavioral|SIESTA|SIESTA is a CBT sleep training for adolescents with ADHD with a focus on sleep hygiene, motivational interviewing and planning and organization.
15766568|NCT04723719|Other|Treatment as usual for ADHD|Participants continue their treatment as usual for ADHD.
15766569|NCT04723706|Diagnostic Test|COVID-19 serology IgG|patients with SCT or CART who decide to get their vaccines we will measure response by therapy by measuring COVID-19 serology IgG at the following schedule: Baseline +5 days after vaccination; 1 month +/- 10 days (after the first dose), 2 months +/- 10 days (after the 2nd dose), 3 months +/- 10 days, 6 months +/- 10 days and 12 months +/- 10 days
15766570|NCT04723693|Other|Qualitative Interview|A single one hour semi structured qualitative interview
15766571|NCT04723680|Other|Qualitative interview|Qualitative semi structured interview
15766574|NCT04723654|Device|Skin Sensor|Placement of wireless wearable vital sign monitors on patients for up to 48 hours
15766575|NCT04723641|Other|functional training exercises|progressive resistive functional strength training from plantigrade foot position conducted for one hour, 3 days/week. The therapist will replace the conventional physical therapy with the progressive resistive functional strength training, when this is consistent with the objectives of the strength training.
15766576|NCT04723628|Behavioral|Intervention group (telephone counseling)|Then, each patient was given 45-60 minutes of individual instruction. The patient training content was prepared based on the Knowledge, Motivation and Behavioral Skills Model (IMB). A total of 12 weeks of follow-up was performed with a weekly short reminder message and a two-weekly phone call. The research data were collected again at the end of 12 weeks.
15766577|NCT04723615|Other|Orebro Musculoskeletal Screening Questionnaire-12|It is a 12-item self-report questionnaire that aims to estimate the severity of the problem, functional impairment, reporting status, cost and recovery time in musculoskeletal problems.
15766578|NCT04723615|Other|Visual Analog Scale|A Visual Analogue Scale (VAS) is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured.
15766579|NCT04723615|Other|The Tampa Scale of Kinesiophobia|The Tampa Scale of Kinesiophobia that was developed in 1990 is a 17 item scale originally developed to measure the fear of movement related to chronic lower back pain.
15766580|NCT04723615|Other|Short Form-12 (SF-12)|The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure.
15766581|NCT04723602|Biological|cAd3-Marburg|A total of 16 healthy adults will be enrolled and vaccinated with a single dose of vaccine. Group 1 (N = 16) will receive a single injection of cAd3-Marburg at 1 x 10^11 Particle Units (PU) vaccine.
15766582|NCT04723602|Biological|cAd3-EBO-S|A total of 16 healthy adults will be enrolled and vaccinated with a single dose of vaccine. Group 2 (N = 16) will receive a single injection of cAd3-EBO-S at 1 x 10^11 Particle Units (PU) vaccine.
15766583|NCT04723589|Biological|Thawed plasma|"Plasma not labeled convalescent plasma is presumed to be free of COVID antibodies, but is not tested for antibodies. To ensure that we are using antibody-free plasma, we will test each unit of plasma with a quick COVID test before it is utilized in this study."
15766584|NCT04723576|Behavioral|Stress First Aid|"Stress First Aid (SFA) is an evidence-based intervention to mitigate the psychosocial impact of COVID-19 on Health Care Workers (HCWs). SFA was initially developed for the United States Navy and Marine Corps as a framework of actions for peer support delivered by individuals without mental health training. SFA is designed to teach simple, supportive actions that can be seamlessly integrated into work environments. SFA training focuses on five essential principles: cover (restore and support a sense of safety), calm (encourage simple strategies such as breathing), connect (engage in and promote social support), competence (improve ability to address crucial needs and concerns), and confidence (increase hope and limit self-doubt and guilt). In this study, we are adapting the SFA model to include HCW-specific examples of SFA actions and case scenarios specific to the COVID-19 pandemic and will implement SFA using a train-the trainer model."
15766585|NCT04723563|Drug|Heparin|25,000 units of unfractionated heparin nebulized 4 times daily for the duration of hospitalization
15766586|NCT04723563|Drug|0.9%sodium chloride|5 mL of 0.9% sodium chloride nebulized 4 times daily for the duration of hospitalization
15766587|NCT04723550|Device|Hospital telemedicine management system|Patients upload data of blood glucose, diet and exercise. Then doctors guide patients' diet, exercise and medication adjustment through the telemedicine system.
15766588|NCT04723550|Other|Usual care|Outpatient/telephone follow-up：continued care, as usual, from their primary care provider through out duration of action 6 months intervention period
15766589|NCT04723537|Drug|Part A: Upamostat 200 mg|1 capsule comprising 200 mg of upamostat and 1 capsule comprising matching placebo.
15766590|NCT04723537|Drug|Part A: Upamostat 400 mg|2 capsules, each capsule comprising 200 mg of upamostat
15766591|NCT04723537|Drug|Part A and B: Placebo|1 or 2 capsules, each capsule a matching placebo
15766592|NCT04723537|Drug|Part B: Upamostat 200 or 400 mg|"Based on dose selection from Part A, Part B Upamostat will be EITHER a single 200 mg dose of upamostat OR two 200 mg doses of upamostat, for a total of 14 days."
15766593|NCT04723524|Combination Product|Jinhua Qinggan (JHQG) Granules, Traditional Chinese Medicine|Jinhua Qinggan granules: 5g/sachet; 1 sachet each time, 3 times daily after meal, dissolve in boil water.
15766594|NCT04723524|Other|Placebo Comparator|Jinhua Qinggan granules simulation (placebo) agent: 5g/sachet; 1 sachet each time, 3 times daily after meal, dissolve in boil water.
15766653|NCT04722965|Procedure|Fistulotomy with marsupialization|A probe is placed in the fistula tract and it's laid open over that probe. The tract is curretted. Wound edges are sutured to the bottom of the fistula using interrupted sutures of vicryl 3-0 completing the marsupialization.
15766768|NCT04722120|Drug|Low contrast dose CT|Underwent spectral CT 20% lower dose contrast media.
15766595|NCT04723511|Other|Global Postural Re-education|"treatment techniques include corrective exercises both local and global to correct forward head posture.
~first session will be to educate participants the treatment sequence. This will be a session of Kendall exercises as described below. This will followed be performing GPR techniques of Anterior Chain stretch in the supine frog like position for 20 minutes followed by posterior chain stretch against the wall for another 20 minutes. This is repeated in the first 6 sessions. Staring from the seventh session the time of holding each position is decreased to 15 minutes and a third position (standing against the wall) is introduced and performed for 15 minutes. Starting from the eighth session a forth position of sitting on the floor position is introduced and performed for another 15 minutes. total of a session will then take a bout 90 minutes."
15766596|NCT04723511|Other|Kendall exercises|"exercises that correct upper crossed syndrome:
~Treatment sequence will be:
~a) Strengthen deep Cervical Flexors via Chin tucks. Repetition will be 15 times repeated for 3 sets.
~(b) Stretching the cervical extensors. This is held for 1 minute and repeated 5 times.
~(c) Strengthening shoulder retraction. Repetition will be 15 times repeated for 3 sets.
~(d) Stretching the pectoralis muscle. This is held for 1 minute and repeated 5 times."
15766597|NCT04723498|Diagnostic Test|screening questionnaire|Fill in screening questionnaire
15766598|NCT04723472|Drug|Cefuroxime containing bismuth quadruple treatment|"Cefuroxime containing bismuth quadruple treatment:
~Rabeprazole 20mg bid po, Colloidal Bismuth Pectin 200mg bid po, Cefuroxime 500mg bid po, Metronidazole 400mg tid po Treatment duration is 14 days."
15766599|NCT04723472|Drug|Classic bismuth quadruple treatment|"Classic bismuth quadruple treatment:
~Rabeprazole 20mg bid po, Colloidal Bismuth Pectin 200mg bid po, Tetracycline 500mg qid po, Metronidazole 400mg tid po Treatment duration is 14 days."
15766600|NCT04723459|Other|ivermectin impregnated mask|mask with ivermectin nano solution
15766601|NCT04723446|Drug|Corsodyl® Alcohol free -0.2 % Chlorhexidine digluconate|Corsodyl® Alcohol-free is a clear to slightly opalescent oromucosal solution with an odour of peppermint that contains 0.2% w/v chlorhexidine digluconate which is an antimicrobial preparation for external use. It is effective against a wide range of Gram negative and Gram positive vegetative bacteria, yeasts, dermatophyte fungi and lipophilic viruses. It is active against a wide range of important oral pathogens and is therefore effective in the treatment of many common oral conditions.
15766602|NCT04723446|Drug|Colgate Peroxyl® -1.5% Hydrogen peroxide|Peroxyl mouthwash is a clear aqua-blue liquid oromucosal solution which 100ml of solution contains 1.5g of Hydrogen peroxide (as 30% Hydrogen Peroxide solution). It is an oral antiseptic cleanser for external use. The principal action is brought about by contact of hydrogen peroxide with peroxidases and catalases present in tissues and saliva, which causes the rapid release of oxygen. This provides mechanical cleansing which flushes out mouth debris and helps in the treatment of oral irritations. This mouthwash is used as a cleanser in the symptomatic relief of minor mouth and gum irritations.
15766603|NCT04723446|Other|Oral-B® Gum & Enamel Care -Cetylpyridinium chloride|The Oral-B® Gum & Enamel Care mouthwash is an oromucosal solution containing Cetylpyridinium chloride (CPC) and used as an adjunct to oral hygiene.
15766604|NCT04723446|Other|No rinsing|No rinsing
15766605|NCT04723433|Other|Oxygen gas -Conservative|Oxygen administration will titrated to a oxyhemoglobin saturation (SpO2) between 90% and 94%.
15766606|NCT04723433|Other|Oxygen gas -Liberal|Oxygen administration will titrated to a oxyhemoglobin saturation (SpO2) higher than 96%.
15766607|NCT04723420|Other|Steamroller technique|Following intravitreal gas injection, patient positioned face down for 4-6 hours and subsequently patient changes the position of the head so that the bubble is then placed directly over the retina break.
15766608|NCT04723420|Other|Direct technique|Following intravitreal gas injection, patient is immediately positioned so that the bubble is placed directly over the retina break.
15766609|NCT04723407|Other|questionnaires|Questionnaire completion
15766610|NCT04723394|Drug|AZD7442|Single dose (× 2 separate IM injections) of 600 mg of AZD7442 or saline placebo on Day 1.
15766611|NCT04723394|Drug|Placebo|Single dose (× 2 separate IM injections) of 600 mg of AZD7442 or saline placebo on Day 1.
15766612|NCT04723381|Other|web based education|Expert support and consultancy were received for the design and preparation of the web page.
15766613|NCT04723368|Device|Automated flying Drone carrying an Automated external defibrillator (AED)|Totally n=5 drones are equipped with automated external defibrillators (AEDs). These drones are deployed by the dispatch centre to cases of suspected out-of-hospital cardiac (OHCA) as a complement to standard care (ambulance/EMS) over up to 9 months during daytime Monday to Sunday 08:00-22:00. The bystander onsite receives instructions from the dispatcher to retrieve the AED outside the house when it has been delivered by the drone. The bystander attaches the AED to the patients chest to facilitate early defibrillation.
15766616|NCT04723342|Drug|Blinatumomab|"Blinatumomab, intravenously, as continuous 24 hours infusion 1-7 days - 5 μg/m2/day, 8-28 day - 15 μg/m2/day
~1 course after induction treatment"
15766617|NCT04723329|Behavioral|Web-based exercise training based on the transtheoretic model|Motivating interviews will be provided to the patients to receive training on the website by contacting them one-on-one. In the following 1st and 3rd months, patients will be contacted individually again to confirm whether they follow the website, and they will be asked to fill in the scales on the website by providing consultancy on the issues they need. In the 6th month, the final test data will be obtained from the website using the same data collection forms.
15766618|NCT04723303|Drug|Umbilical Cord Lining Stem Cells|An IV infusion of ULSCs will be administered.
15766619|NCT04723290|Diagnostic Test|Serological tests for SARS Cov-2|Each participant will have a blood test on a dry tube of maximum 8 ml of whole blood
15766654|NCT04722965|Procedure|Fistulotomy with open wound|A probe is placed in the fistula tract and it's laid open over that probe. The tract is curretted. The wound is left open.
15766676|NCT04722796|Device|TAVR with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution)|Transcatheter aortic valve replacement (TAVR) with Venus A plus using supra-annular sizing and THV implantation technique (Hangzhou solution)
15766724|NCT04722484|Drug|Vericiguat (BAY1021189)|Oral single dose of 2.5 mg (2 x 1.25 mg immediate release tablet)
15766620|NCT04723277|Behavioral|Tealeaf-Mansik Swasta (Tealeaf)|Tealeaf is a task-shifting intervention in which teachers deliver transdiagnostic mental health care. Mental health challenges are understood through basic functional behavior assessments, providing a framework for the analysis of observable behaviors. Teachers deliver care primarily through the incorporation of basic therapeutic interactions into classroom instruction time, supplemented by one-on-one interactions with the child and family. Teachers receive ongoing supervision and support from the intervention team including monthly site visits supplemented by monthly and as-needed telephone discussions.
15766621|NCT04723277|Behavioral|Enhanced Usual Care (EUC)|Enhanced Usual Care (EUC) is a less intensive version of the Tealeaf intervention. The EUC service package has been designed to be the most intensive form of care that could be envisioned as viable in the study setting in the foreseeable future without a significant increase in resource investment.
15766622|NCT04723264|Behavioral|Food protocols|"Participants will engage in several activities (i.e. offering a variety of foods and age appropriate games, etc.) regarding eating behaviors.
~Participants will be asked to videotape interactions using a secure system. An alternative option may be provided if this videotaping is not acceptable."
15766623|NCT04723251|Behavioral|taking photographs|"Participants will photograph images (using a cell phone) that invoke a feeling of gratitude. At least 1 photograph (at any time of the day) should be taken for a period of three weeks.
~Once the photo images are captured, the participant should spend a moment looking at the image and reflecting on why they are grateful for the subject of the photograph."
15766624|NCT04723238|Drug|Duloxetine 60mg Test Drug Enteric Coated Granules|Investigational Medicinal Product
15766625|NCT04723238|Drug|Duloxetine 60mg Reference Product Enteric Coated Granules|Cymbalta (Eli Lilly)
15766626|NCT04723225|Other|Cat-Cow Yoga|Cat-Cow is one of the essential postures in yoga for its beneficial reasons. It is an alternate shift of posture from flexion of the back (rounded) to the extension of the back (arched). During each set of movement, inhalation and exhalation will be guided
15766627|NCT04723199|Device|Electrocautetery LAMS|Electrocautetery LAMS
15766628|NCT04723186|Drug|MT1002|Monotherapy of MT1002, 3 doses via intravenous (IV) + infusion
15766629|NCT04723173|Device|Feature for noise reduction (on)|The noise reduction feature shall support the hearing aid user in noisy situations and shall reduce the listening effort.
15766630|NCT04723173|Device|Feature for noise reduction (off)|To show the advantage of the noise reduction feature there is a comparison without the feature necessary.
15766631|NCT04723160|Diagnostic Test|Software assisted imaging diagnosis|In the test group, diagnoses are given with the help of the software.
15766632|NCT04723147|Drug|Carbidopa Levodopa|Patients will receive L-DOPA at doses ranging from 150 to 450 mg administered at a ratio of 1 mg carbidopa for every 4 mg L-DOPA. Starting dose is 150 mg/day with dose escalation 150 mg/day per week to a final dose of 450 mg/day
15766633|NCT04723147|Drug|Placebo|A placebo is a sugar pill that has no therapeutic effect and will be administered orally. Participants will receive 1 placebo tablet matching the Carbidopa Levodopa tablet.
15766635|NCT04723121|Diagnostic Test|Urine ELISA for immunological markers (IL-2 and IL-10)|IL-2 and IL-10 levels were measured in the supernatants. Natural human-produced IL-2 and IL-10 concen¬trations were determined in the urine of all patients and controls by solid phase ELISA Quantikine IL-2 Immunoassay and IL-10 Immunoassay, respectively
15766636|NCT04723121|Diagnostic Test|Reverse transcriptase-quantitative polymerase chain reaction (RT-qPCR) analysis|blood samples using QIAamp® RNA Blood Mini kit (QIAGEN, USA). 1 μg of total RNA was reverse transcribed with random primers, using High Capacity cDNA Archive Kit (Applied Biosystems, Foster City, CA, USA). RT-qPCR analysis was carried out with SYBER Green PCR Master Mix (Applied Biosystems, Foster City, CA, USA). Primers for TNF-α, CTLA4, T-bet+, GATA3+, FoxP3+ and GABDH as PCR control
15766637|NCT04723108|Other|Destek V4 Virtual Reality Headset|The DESTEK V4 is a smartphone VR headset made by DESTEK, a manufacturer based in the US. This mobile virtual reality headset is compatible with most iOS and Android smartphones, as long as their screen size is between 4.5 and 6.
15766638|NCT04723095|Other|Follow-Up|Receive follow up
15766639|NCT04723095|Other|Medical Chart Review|Review of medical records
15766640|NCT04723069|Drug|Fuke Qianjin capsule|Experimental group
15766641|NCT04723069|Drug|metronidazole tablets + doxycycline hyclate tablets|Active Comparator group
15766642|NCT04723056|Device|Use of Zemedy Application|8 weeks of CBT via the Zemedy Application.
15766643|NCT04723043|Device|mechanical ventilation modes|ventilation with pressure controlled mode in laparoscopic abdominal surgery ventilation with volume controlled mode in laparoscopic abdominal surgery
15766644|NCT04723030|Drug|carleilizumab+apathy mesylate+radiotherapy+paclitaxel (albumin-bound)|"Carrilizumab ：200mg,q2w; Apatinib :250mg,d1; which is taken continuously for 5 days and stopped for 2 days, and stopped for 2 weeks after radiotherapy.
~Taxol :125mg/m2,q2w; Gemcitabine :1000mg/m2, q2w; cisplatin :25mg/m2, q2w; Radiotherapy:30Gy, divided into five times and completed within one week."
15766645|NCT04723017|Other|Retrospective analysis cohort|We analyze pre-existing data base and develop machine-learning-based system that predicts the risk of hypoxemia
15766646|NCT04723017|Other|Prospective validation cohort|We validate our model to predict the risk of hypoxemia to prospective cohort
15766647|NCT04723004|Combination Product|Toripalimab combined with Bevacizumab|"Experimental group:
~Toripalimab, 240mg, IV infusion, every 3 weeks (q3w). combined with Bevacizumab 15mg/kg, IV infusion, every 3 weeks (q3w), Continuous infusion, in a cycle of 3 weeks (21 days), until occurrence of termination event specified in the protocol."
15766648|NCT04723004|Drug|Sorafenib|"Control group:
~Sorafenib 400mg, po, Bid, continuous administration, until occurrence of termination event specified in the protocol."
15766649|NCT04722991|Drug|Runcaciguat (BAY1101042)|Oral doses of runcaciguat
15766650|NCT04722991|Other|Placebo|Oral doses of matching placebo
15766651|NCT04722978|Drug|Gemcitabine and carboplatin plus antibiotic (moxifloxacin)|Standard chemotherapy (gemcitabine and carboplatin) plus antibiotic (moxifloxacin)
15766652|NCT04722978|Drug|Gemcitabine combined with carboplatin plus placebo|Standard chemotherapy (gemcitabine and carboplatin) plus placebo
15766725|NCT04722471|Drug|Vaginally administered progesterone|The artificial endometrial preparation for an embryo transfer with the use of 400 mg vaginal tablet (one tablet twice a day) or 200 mg (two tablets twice a day)
15766655|NCT04722952|Drug|Visilizumab|Azacytidine 75mg/(m2.d) by IV on days 1-7 of every cycle. Anti-PD-1 mAb 200mg by IV on day 8 of every cycle. Homoharringtonine(HHT) 2mg/(m2.d) by IV on days 1-6 of every cycle Cytarabine 10mg/(m2.d) by SC on days 1-7 of every cycle Granulocyte colony-stimulating factor(G-CSF) 300ug/d by SC on days 1-7 of every cycle，until absolute neutrophil count(ANC) > 5X109／L or white blood cell（WBC）> 20X109／L.
15766656|NCT04722939|Diagnostic Test|Cerebral oxygenation|Cerebral oxygenation will be monitored with the FORESIGHT Elite cerebral oximeter during the first 72h of critical illness, and during subsequent hemodialysis sessions
15766657|NCT04722926|Other|PJI|patients having had a PJI managed at the CRIOAc Lyon, with or without relapse
15766658|NCT04722913|Diagnostic Test|Photogrametry , flexion rotation (FRT) test, Diagnosis of CGH according diagnostic criteria of the Cervicogenic Headache International Study Group (CHISG)|"Photogrammetry is the science and technology of obtaining reliable information about physical objects and the environment through the process of recording, measuring and interpreting photographic images and patterns of electromagnetic radiant imagery and other phenomena.
~Flexion rotation (FRT) test:
~FRT is a manual examination technique with high sensitivity and specificity. It is performed with the patient in supine by passively taking the cervical spine into full flexion. End-range cervical flexion imparts ligamentous tension that impedes movement at vertebral segments below C2.7 Maintaining the flexion position, the patient's head is then rotated to each side until the patient reports pain or the operator determines that end of motion has been achieved. It is then determined if a restriction in ROM is present."
15766659|NCT04722900|Other|intrauterine exposure to elevated glucose levels|intrauterine exposure to elevated glucose levels
15766660|NCT04722887|Biological|Alpha-1 15%|Alpha1-Proteinase Inhibitor (Human), 15%, Subcutaneous infusion
15766661|NCT04722887|Biological|Liquid Alpha1-Proteinase Inhibitor (Human)|Intravenous infusion
15766662|NCT04722874|Device|Ortho-k lenses|Ortho-k lenses will be administered nightly.
15766663|NCT04722874|Device|RLRL|RLRL will be performed twice a day with an interval of at least 4 hours, each treatment last 3 minutes. Nightly treatment should be performed at least 30 minutes before ortho-k lens insertion.
15766664|NCT04722861|Other|GVFQ-40|GVFQ-40 is a 40-item questionnaire developed to evaluate the visual ability of glaucoma patients in detail. It consists of 40 items and measures the impact of glaucoma on restriction of participation in daily activities in five domains of functioning. Each item is rated on a five-level scale from ''no difficulty'' to ''can't do because of vision''. Another possible response is that the activity is not performed for nonvisual reasons.
15766665|NCT04722848|Drug|Ponatinib + Blinatumomab|"Patients aged 18-65 will receive Ponatinib at the dose of 45 mg/day for the first 22 days and then will reduce the dose to 30 mg (depending on the morphologic and molecular response), whereas patients older than 65 years will start Ponatinib at 30 mg/day, in order to avoid TAEs. Patients will continue treatment with Ponatinib up to day 70 (10 weeks of treatment), except for disease progression, intolerable toxicity, or withdrawal from study. Thereafter:
~Patients will receive Blinatumomab (minimum 2 cycles, up to a maximum of 5).
~Patients not achieving a CHR after 2 cycles of Blinatumomab will go off-study. After the 2 cycles of Blinatumomab patients aged 18-65 will be stratified for transplant allocation"
15766666|NCT04722848|Drug|Chemotherapy + Imatinib|patients aged 18-65 will receive chemotherapeutic scheme combined with Imatinib. Elderly patients will receive Imatinib plus mild chemotherapy.
15766667|NCT04722835|Procedure|Bronchoscopy with Bronchoalveolar Lavage (BAL)|"Bronchoscopy w/ (BAL): The bronchoscope will be introduced through mouth and directed into the right middle lobe bronchus for bronchial lavage. The BAL will be performed with two 60-mL aliquots (total of 120 ml) of saline in each of medial and lateral segments of Right Middle Lobe (RML) (total 240 ml lavage).
~Albuterol Administration: The subjects will inhale 2 puffs of respiratory medication albuterol, then repeat the breathing test.
~Peak Flow Measurement: Subjects will breathe in fully then out forcefully into the handheld device.
~Pulmonary Function Test w/ Spirometry: will be used for determination of COPD and its severity. The PFT measures breathing capacity and lung function with different types of breathing maneuvers including flow-volume curve, single breath CO diffusing capacity, and total lung capacity.
~Blood draw
~Medical Health and Symptom Questionnaires
~Physical Exam by study doctor to determine suitability and safety for participation."
15766668|NCT04722822|Behavioral|(Intervention) Recommending HPV vaccine for patients 9-10 years of age|Providers within intervention practices will receive training which includes both standardized communication strategies and strategies for switching from 11-12 years to 9-10 years including: challenges with 11-12 strategy, long-term immunity, success of other practices and tips to help standardize to age 9-10. Trainings will be a combination of online and in-person or virtual. Annual trainings will be offered and providers will receive Maintenance of Certification credits (MOC) for participating. Providers will routinely recommend HPV starting at age 9 for all patients -- which is already approved for this vaccine but is not routinely recommended at age 9 years.
15766669|NCT04722822|Behavioral|(Control) Recommending HPV vaccine for patients 11-12 years of age|Providers within control practices will receive a training on standardized communication for HPV vaccine including: using strong recommendations, using presumptive recommendation, providing specific phrases to use with parents, answering common questions and, HPV vaccine as a cancer prevention. Annual trainings will be offered and providers will receive professional development credit (MOC).
15766670|NCT04722809|Drug|Botulinum toxin injection|Injection in the temporal and masseter muscles: in 3 points in the masseter muscles and in 2 points in the temporal muscles.
15766671|NCT04722809|Other|QOL-Brux|Questionnaire evaluating the symptoms of bruxism Inclusion and 3 months post-injection
15766672|NCT04722809|Other|Muscular strength of the jaw|"Measurement in the jaw with a dynamometer connected to a sensor placed on the 1st molar on the right side.
~At inclusion and 1 month post-injection."
15766673|NCT04722809|Other|Intensity and frequency of episodes of nocturnal bruxism|Measurements via a portable electromyography system, coupled with a heartbeat sensor (Bruxoff®). Measurements performed during normal sleeping conditions at home before injection and 1 month after.
15766674|NCT04722809|Other|visual analogue pain scale|Evaluation of jaw pain. At inclusion and 3 months post-injection
15766675|NCT04722809|Other|Endobuccal and linea alba photographs|"anonymous endobuccal and linea alba photographs (line on the inner face of the cheeks as the result of chronic friction).
~At inclusion"
15766726|NCT04722458|Other|Lower Urinary Tract Dysfunction Research Network Symptom Index-29 (LURN SI-29)|LURN SI-29
15766727|NCT04722458|Other|IPSS|International Prostate Symptom Score
15766677|NCT04722796|Device|TAVR with Venus A plus using annular sizing and THV implantation technique|Transcatheter aortic valve replacement (TAVR) with Venus A plus using annular sizing and THV implantation technique (Traditional sizing strategy)
15766678|NCT04722783|Behavioral|Parent-Child-Interaction Therapy adapted for children with autism spectrum disorder (PCIT-A)|PCIT is a behavioral family therapy approach emphasizing the integration of traditional child play therapy techniques within a behavioral framework of parent-child therapy and was developed by Eyberg (1988). It is based on attachment theory, social learning theory, and parenting styles theory. Recently, the intervention was adapted to children with ASD by our team (McNeil, Quetsch, & Anderson, 2019). PCIT-A will last about 8 months, 1 day per week, 60min per day (see Study Protocol, Fig. 2).
15766679|NCT04722783|Behavioral|Early Start Denver Model (ESDM) intervention|ESDM intervention provides intensive teaching by trained therapists and parents during natural play and relationship-focused daily routines. It is evidence-based and uses principles of developmental psychology and applied behavior analysis. It was designed for toddlers and preschoolers with autism spectrum disorder by Rogers and Dawson (2010). The first intensive part of ESDM intervention (20h per week) will last 40 weeks of intervention within a period of 12 months. It includes 2 days per week for 6h a day clinic therapy, and 5 days per week for 1h homework tasks, and 2 days per week for 1.5h an early special needs education at home. After the first 12 months, children receive the second lower intensity part of ESDM (7 hours per week). It includes 1 days every two weeks 1h day clinic therapy, and 5 days per week for 1h homework tasks, and 1 days per week for 1.5h an early special needs education at home (see Study Protocol, Fig. 2).
15766680|NCT04722783|Behavioral|1-hour ESDM|The active control group for PCIT-A stays in the ESDM day clinic therapy for the 12 hours per week while the PCIT-A group will receive 11 hours of ESDM day clinic therapy and 1 hour PCIT-A per week (see Study Protocol, Fig. 2).
15766681|NCT04722783|Behavioral|Early special needs education (ESNE)|The wait-list control group will receive early special needs education. It consists of a 90-minute visit at participants' homes once a week by an employee educated in early special needs education. As soon as space in ESDM is available children will receive the ESDM intervention (stepped-wedge design, see Study Protocol, Fig. 2).
15766682|NCT04722770|Device|PhotoniCare OtoSight Middle Ear Scope|PhotoniCare OtoSight imaging using a near-infrared laser
15766683|NCT04722757|Procedure|ta-IPAA|A trans-anal port (gelpoint path, Applied Medical®) will be used for transanal acces and pneumopelvis will be created. The initial purse string is to be placed approximately 3cm above the dentate line, followed by a rectotomy. The perirectal dissection is then continued and should be pursued for at least 5cm. More proximal dissection can be done by transabdominal access. After completion of the proctectomy, a double purse string anastomosis is performed after creation of the J-pouch. A defunctioning loop ileostomy can be placed according to surgeon's preference.
15766684|NCT04722757|Procedure|tabd-IPAA|Patients in the control group will undergo a rectal dissection by laparotomy, Pfannenstiel incision, (hand-assisted) laparoscopy, single port laparoscopy or robotic surgery, but performed from the abdominal side (tabd-IPAA). Dissection will be performed down to the pelvic floor and include the distal rectum. It is anticipated that most dissection will occur using the TME plane, however, close rectal dissection is also acceptable. Transection of the distal rectum approximately 2 cm above the dentate line will be performed using a linear stapler of the surgeon's choice. After placing the anvil in the J-pouch, a circular stapler will be introduced through the sphincter and a circular anastomosis will be performed. A defunctioning loop ileostomy can be placed according at the surgeon's discretion.
15766685|NCT04722744|Procedure|screwmented metal frameworks|Intervention group: in which the edentulous area will be restored with 3-implant, screwmented CAD/CAM frameworks constructed based on planned implant positions
15766686|NCT04722731|Behavioral|Confident Parents - Brave Children (CPBT)|"Session 1: Psychoeducation.
~Session 2: How to decrease criticism and rejection. Skills that provide a warm parenting style and acceptance of the child: validation and child directed play/activities.
~Session 3: Strategies to increase the autonomy of the child. The parents will learn how to use a stepladder approach to decrease overprotective behaviours.
~Session 4: How to decrease modelling of anxious behaviours and how to be a brave role model.
~Session 5: How to recognise and respond when your child is anxious. How to help your child approach new or scary things by using a stepladder approach.
~Session 6: Review of the principles and skills learned during the program. The group members will make a plan for how to continue the work on their own."
15766687|NCT04722731|Behavioral|"Self-help book What all parents ought to know"|Participants in the control group will receive a self-help parenting book containing general research-based parenting strategies. They will be instructed to read the book within the 10 weeks from baseline to post.
15766688|NCT04722718|Drug|Sintilimab+Apatinib+Albumin-Bound Paclitaxel(Nab-Paclitaxel)+Carboplatin|Sintilimab:200mg,ivgtt,d1,21days/cycle;Apatinib:250mg po,d1-14days,21days/cycle;Albumin-Bound Paclitaxel(Nab-Paclitaxel):125mg/m2,ivgtt,d1,d8,21days/cycle;Carboplatin:AUC=1.5,ivgtt,d1,d8, 21days/cycle.Monitoring of blood routine, biochemical and urine routine, electrocardiogram, and record the patient's drug-related adverse reactions every cycle,according to the curative effect of patients, compliance and tolerance, neoadjuvant therapy 6 cycles,every 2 cycles to evaluate curative effect (ultrasonic, breast X-ray CT, bone scan, brain, lungs, assessment and breast MRI imaging).
15766689|NCT04722705|Device|fractional Er:YAG laser|"At baseline, three lesions were randomized. Topical anesthetic cream was applied to the scar 30 minutes before laser treatment.
~The same dermatologist performed 2,940 nm Er:YAG fractional laser. (long pulse mode, 1500mJ, 2Hz, 2 pass) The face was cooled after treatment with gauze soaked in ice water. The laser treatment was conducted total three sessions, immediately at suture removal, 4 weeks after suture removal and 8 weeks after suture removal. The evaluation of scar site was conducted 3 months later after last treatment."
15766690|NCT04722705|Device|Intense pulse light|"At baseline, three lesions were randomized. Topical anesthetic cream was applied to the scar 30 minutes before laser treatment.
~The same dermatologist performed IPL. (irridation energy: 12.5J/cm2, pulse duration: 10ms, 1pass) The face was cooled after treatment with gauze soaked in ice water. The laser treatment was conducted total three sessions, immediately at suture removal, 4 weeks after suture removal and 8 weeks after suture removal. The evaluation of scar site was conducted 3 months later after last treatment."
15766723|NCT04722497|Other|Sound Education|All physicians and nurses involved in cesarean births will be given an education intervention explaining the impact of noise levels on stress and focus. The SoundEar device will be used as an intervention tool to inform operating room physicians and nurses when the noise level is above the desired level.
15766691|NCT04722692|Diagnostic Test|Delayed SLND|"SLND performed after surgery for DCIS or other pre-invasive lesions, where final pathology showed invasive breast cancer. Patients have received SPIO in the breast at the first operation, prior to dissection and resection and the SLN has already been marked with SPIO. These SLNs are to be removed.
~SLND is divided into the following steps:
~Transcutaneous signal
~Incision in the axilla (skin, subcutaneous fat and fascia) and In situ signal
~SLN identification in situ
~SLN excision and signal ex vivo
~Background axillary counts. For step d the radioactive counts are registered for each SLN that has been excised. When the procedure is completed successfully with SPIO, then background axillary isotope counts are registered and, if present, SLND continues as described above with the isotope as primary tracer."
15766692|NCT04722692|Diagnostic Test|Late SLND|"SLND performed after surgery for DCIS or other pre-invasive lesions, where final pathology showed invasive breast cancer. Patients will be injected with radioisotope in the operated breast before SLND according to standard of care. Any SLNs detected with this intervention are to be removed.
~SLND is divided into the following steps:
~Transcutaneous signal
~Incision in the axilla (skin, subcutaneous fat and fascia) and In situ signal
~SLN identification in situ
~SLN excision and signal ex vivo
~Background axillary counts. For step d the magnetic counts are registered for each SLN that has been excised. When the procedure is completed successfully with the isotope, then background axillary iSPIO counts are registered and, if present, SLND continues as described above with the SPIO as primary tracer."
15766694|NCT04722666|Drug|MIJ821 Intravenous Injection|MIJ821 supplied in vials to be prepared on a mg/kg basis and to be administered for 40 minutes IV infusion on Day 1, Day 15 and Day 29
15766695|NCT04722666|Drug|Placebo Intravenous Injection|40 minutes IV infusion of 0.9% sodium chloride solution on Day1, Day 15 and Day 29
15766696|NCT04722653|Drug|NNC0194-0499|1 single dose administered subcutaneously (s.c. - under the skin)
15766697|NCT04722653|Drug|Placebo (NNC0194-0499 )|1 single dose administered subcutaneously (s.c. - under the skin).
15766698|NCT04722640|Drug|SKYRIZI|SKYRIZI
15766699|NCT04722627|Drug|AT-752|Parallel Assignment
15766700|NCT04722627|Drug|Placebo|Parallel Assignment
15766701|NCT04722614|Other|Music|Classic music hearing at amplitude approximately 60-80 dB using MP3 player connected to headphone with noise canceling property
15766702|NCT04722614|Other|Essential oil|Bergamot oil inhalation through a piece of cotton gauze (2 × 2 cm square shape) with 0.5 cc of bergamot oil. It will be attached to the collar of the patient's clothes gown, approximately 15 cm below their nose.
15766703|NCT04722614|Other|Control|The routine intensive care unit sedation protocol
15766704|NCT04722601|Drug|Venetoclax|A drug used with other drugs to treat acute myeloid leukemia that is newly diagnosed. It is used in adults who are 75 years and older or in adults who cannot be treated with other anticancer drugs. Venetoclax is also used to treat chronic lymphocytic leukemia and small lymphocytic lymphoma in adults. It is also being studied in the treatment of other types of cancer.
15766705|NCT04722601|Drug|Obinutuzumab|Obinutuzumab is a prescription medicine that can be used in combination with other cancer medicines to treat follicular lymphoma (a type of non-Hodgkin lymphoma), or to help delay the progression of this disease.
15766706|NCT04722601|Drug|CC-486|An oral form of azacitidine (a standard chemotherapy drug).
15766707|NCT04722588|Other|Introducing clinical pharmacists to the interdisciplinary ED team.|There will be two shifts, one shift from 08.00 - 15.00 and one from 12.00 - 19.00. Consequently, the hours of the day when the majority of patients arrives, are covered and the pharmacist capacity is doubled during the busiest time of the day. Early mornings are normally relatively slowed paced and the pharmacist may use this time to follow up on patients admitted during the night (from 19.00 - 08.00), in particularly those who have been admitted to wards without an assigned pharmacist.
15766708|NCT04722575|Drug|Cobimetinib 20 MG Oral Tablet|Cobimetinib 60 mg qd p.o. from week 1 to week 3 and week 5 to week 6. Week 4 off.
15766709|NCT04722575|Drug|Vemurafenib 240 Mg Oral Capsule|960 (arm A) /720 (arm B) mg bid p.o. from week 1 to week 6.
15766710|NCT04722575|Drug|Atezolizumab 1200 MG in 20 ML Injection|840 mg IV for 2 cycles for Arm B and C. After surgery in all arms 1200 mg IV for 52 weeks
15766711|NCT04722562|Drug|Vericiguat (BAY1021189)|Oral single dose of 2.5 mg (2 x 1.25 mg immediate release tablet)
15766712|NCT04722549|Dietary Supplement|Placebo|Cellulose
15766713|NCT04722549|Dietary Supplement|Butyrate|Sodium butyrate
15766714|NCT04722536|Procedure|Cervico-isthmic cerclage|There is no intervention in this study. It's an observational retrospective study, before/after.
15766715|NCT04722523|Drug|Cisplatin|Cisplatin 75mg/m2 AUC 5 on weeks 2, 5, and 8
15766716|NCT04722523|Drug|Carboplatin|Carboplatin AUC 5 on weeks 2, 5, and 8
15766717|NCT04722523|Drug|Docetaxel|Docetaxel 75mg/m2 on weeks 2, 5, and 8
15766718|NCT04722523|Drug|Cetuximab|Cetuximab 400mg/m2 on week 1, 250mg/m2 on weeks 2, 3, 4, 5, 6, 7, 8, 9, 10
15766719|NCT04722523|Drug|Cemiplimab|Cemiplimab 350mg on weeks 2, 5, 8, 11; if adjuvant radiation +/- chemotherapy is omitted, Cemiplimab will be administered on weeks 16, 19, 22, 25, 28, 31, 34, 37
15766720|NCT04722523|Procedure|Surgical Resection of Primary +/- Neck Dissection|Twenty-eight days (+ 7 days) following the 3rd cycle of neoadjuvant therapy, patients will then undergo definitive surgical resection of the primary site +/- neck dissection(s).
15766721|NCT04722523|Radiation|Post-operative radiation therapy|Post-operative radiation therapy +/- radiosensitizing agent(s) will be administered per standard-of-care based on pathologic staging of the surgical specimen. If there is an excellent response to treatment with a high degree of downstaging the addition of adjuvant radiation may be omitted if NCCN guidelines are met. If the pathologic stage following induction systemic therapy and surgery is ypT1-2N0 without the presence of adverse features that include positive margins or a combination of perineural invasion, vascular invasion, and a depth of invasion of >0.5mm, adjuvant radiation will not be administered, consistent with the NCCN guidelines [2]. Otherwise, patients will receive adjuvant RT-based treatment with standard radiation techniques.
15766722|NCT04722510|Device|repeated transcranial magnetic stimulation|Transcranial magnetic stimulation is a non-invasive brain modulation technique that has proven to be a useful study and treatment tool in neuropsychiatric disorders. This technique allows to increase (with high frequency protocol, > 1 Hz) or decrease (with low frecuency protocols, 1 hz or less) neuronal excitability in a focused cortical area.
15766729|NCT04722445|Diagnostic Test|Early ultrasound measurement of quadriceps shortening during neuromuscular electrical stimulation (NMES)|NMES will be applied to the quadriceps muscle to generate muscle contraction. Ultrasound measurement of the quadriceps thickness will be provided during contraction and rest, and the shortening of the quadriceps muscle will be measured. A second measurement using Shear-wave elastography measurement will also be undertaken. The measures will be undertaken at day 1 of neuromuscular blockers liberation (if any) as well as at day 3 and day 7 for the patients that will still be received mechanical ventilation at that time.
15766730|NCT04722432|Device|Outside the Scope (OTS), Detachable Catheter System|Evaluation of Deployment Capability and Accuracy of an Outside the Scope (OTS), Detachable Catheter System for Ablation of Peripheral Lung Lesions: An Ex-Vivo Human Lung Model Study
15766731|NCT04722419|Other|Probe meal|The probe meal will be served in 112 Kcal portions (16 g white bread, 10 g cheese, 10 g jam, 3.25 g butter, and 50 mL orange juice) up to the level of maximal satiation.
15766732|NCT04722406|Other|This item is not applicable to our observational study.|This item is not applicable to our observational study.
15766733|NCT04722393|Other|Exercise|Exercise training
15766734|NCT04722380|Procedure|periodontal regenerative surgery|Procedure/Surgery: open flap debridement Open flap for removal of diseased periodontal tissues and necrotic cementum , using xenogenic bone graft with or without Nigella Sativa oil extract
15766735|NCT04722367|Behavioral|Art Pedagogy and Mindfulness|Each participant will take part in four 1-hour sessions. Study activities include guided meditation, close looking, drawing, writing, and storytelling. Each session will begin with a guided meditation that is followed by an exercise inspired by two works of art, and end with an opportunity for students to reflect on the experience.
15766736|NCT04722354|Other|Hyperinsulemic euglycemic clamp|Following a 12-hour overnight fast at the CRU (including abstinence from caffeine containing foods and beverages), insulin sensitivity will be measured using the criterion method of the euglycemic clamp. Participants will have not performed vigorous physical activity for at least the previous 24 h, and be free of acute illness for the prior 2 weeks. An intravenous catheter will be placed in an antecubital vein for subsequent insulin (40 mU/m2-min) and glucose infusions and for stable isotope (6, 6-2H2) infusions to measure insulin sensitivity.
15766737|NCT04722354|Procedure|Muscle Biopsy|One biopsy taken prior to clamp and a second biopsy taken 30-45 min after the start of the clamp. A biopsy of the Vastus Lateralis muscle will be performed on the leg/thigh using the Bergstrom technique.
15766738|NCT04722354|Dietary Supplement|Oral abscisic acid (ABA)|Those in this group will receive ABA (95 µg ABA and 300 mg of corn starch)
15766739|NCT04722354|Other|Placebo|Those in this group will receive placebo (300 mg cornstarch)
15766740|NCT04722341|Behavioral|Time-Restricted Eating (TRE)|8-hour daily eating period, starting 1-3 hours after waking up
15766741|NCT04722341|Behavioral|Control|More than equal to a 12-hour daily eating period
15766742|NCT04722328|Diagnostic Test|CSF metagenomic next generation sequencing (mNGS)|TestCSF routine, biochemical, smear staining (Gram staining, acid fast staining, ink staining), culture and mNGS。
15766743|NCT04722315|Dietary Supplement|Modified Atkins diet|12 weeks of modified Atkins diet
15766744|NCT04722289|Behavioral|Together on Diabetes|Social and emotional support'; 'Assistance in daily management'; and 'Linkage to healthcare services'
15766745|NCT04722276|Other|positive end expiratory pressure|7cmH2O of positive end expiratory pressure with fraction of inspired oxygen 100% applied during induction of anesthesia
15766746|NCT04722276|Other|fraction of inspired oxygen 80%|fraction of inspired oxygen 80% applied during induction of anesthesia
15766750|NCT04722237|Behavioral|Acceptance and Commitment Therapy|Acceptance and Commitment Therapy (ACT) is an evidence-based psychological therapy that has been used to improve physical and mental health among adults with health conditions, including cancer (Graham, Gouick, Krahe, & Gillanders, 2016). It fosters engagement with, rather than avoidance of, painful experiences, to move towards acceptance of unchangeable difficulties alongside building a rich and meaningful life despite the presence of ongoing problems.
15766751|NCT04722224|Other|Home-based pulmonary rehabilitation|The reabilitAR program includes the self-management educational program Living Well with COPD. The exercise training will include endurance, resistance/strength, flexibility and balance training.
15766752|NCT04722211|Dietary Supplement|PS128|daily ingestion of 2 capsules of Lactobacillus plantarum PS128 (>10 billion CFU/capsule)
15766753|NCT04722211|Dietary Supplement|placebo|daily ingestion of 2 capsules which only contained 425 ± 25 mg microcrystalline cellulose
15766754|NCT04722198|Dietary Supplement|PS128|daily ingestion 2 capsules of Lactobacillus plantarum PS128 (>10 billion CFU/capsule)
15766755|NCT04722185|Diagnostic Test|Veriton SPECT/CT|The Veriton system represents an FDA approved (510k cleared) new generation of SPECT/CT systems. It consists of 12 small gamma cameras arrayed in a circle around the patient, and is coupled to a 64-slice CT system.
15766756|NCT04722172|Drug|Acalabrutinib|Acalabrutinib for a minimum of 13 cycles and maximum 26 cycles.
15766757|NCT04722172|Drug|Obinutuzumab|Obinutuzumab will be administered during Cycles 2-7.
15766758|NCT04722159|Device|Renal denervation|Catheter-based inhibition of renal sympathetic nerve traffic.
15766759|NCT04722146|Drug|Teclistamab|Participants will receive teclistamab.
15766760|NCT04722146|Drug|Daratumumab|Participants will receive daratumumab.
15766761|NCT04722146|Drug|Pomalidomide|Participants will receive pomalidomide.
15766762|NCT04722146|Drug|Lenalidomide|Participants will receive lenalidomide.
15766763|NCT04722146|Drug|Bortezomib|Participants will receive bortezomib.
15766764|NCT04722146|Drug|Nirogacestat|Participants will receive nirogacestat.
15766765|NCT04722133|Drug|HERZUMA+mFOLFOX|Herzuma (Trastuzumab-pkrb) 4mg/kg after 6mg/kg loading D1 5FU 400mg/m2 bolus+2400mg/m2 infusion for 46 hrs D1 Leucovorin 200mg/m2 D1 Oxaliplatin 85mg/m2 D1 every 2 weeks
15766766|NCT04722120|Radiation|Low radiation dose CT|Underwent spectral CT with 30% lower radiation dose
15766767|NCT04722120|Radiation|Conventional CT (radiation)|Underwent spectral CT without change of radiation.
15766769|NCT04722120|Drug|Conventional CT (contrast agent)|Underwent spectral CT without change of contrast media doses.
15766770|NCT04722107|Drug|Gene Replacement Therapy by rAAV2/8-hCYP4V2|Gene Replacement Therapy by rAAV2/8-hCYP4V2
15766771|NCT04722094|Diagnostic Test|Full periodontal chart|A full periodontal chart will be carried out including all biometric periodontal variables: Probing Pocket Depth (PPD), Bleeding on Probing (BoP), presence of Plaque, recession (REC), Full Mouth Plaque Score (FMPS), Full Mouth Bleeding Score (FMBS), presence of furcation and mobility. Periodontal status, as assessed by the periodontal chart, will be evaluated following the New Classification of Periodontal and Peri implant diseases.
15766772|NCT04722094|Other|Saliva sampling|Saliva samples for miRNAs detection will be taken before starting the visit.
15766773|NCT04722081|Other|physical therapy|physical therapy-specific exercises
15766774|NCT04722068|Other|Kinetics test|Subjects will participate in two study visits to evaluate lipoprotein kinetics before and after administration of evinacumab.
15766775|NCT04722055|Diagnostic Test|Multigene Methylation Detection Kit|Eligible participants are required to take stool samples for multigene methylation detection and gene sequencing, undergo colonoscopy examination, and have a biopsy when necessary (gold standard).
15766776|NCT04722042|Other|place-based mapping|Adjusting the electric frequency filters to align with the cochlear place frequency
15766777|NCT04722042|Other|default mapping|Default frequency filter assignments
15766778|NCT04722029|Biological|Adenovirus Specific T lymphocytes|ADV-VSTs is being proposed for the treatment of refractory ADV infection and/or disease in these populations using haploidentical donors for ease of donor selection, antiviral immunity, coupled with a high-throughput antigen stimulation/IFN-γ capture system (Miltenyi Biotec, CliniMACS Prodigy® System) for rapid and less costly isolation of ADV-VSTs.
15766779|NCT04722003|Biological|Meningococcal Group B Vaccine|A combination vaccine consisting of recombinant proteins Neisserial adhesin A (NadA), Neisserial Heparin Binding Antigen (NHBA), and factor H binding protein (fHbp), Outer Membrane Vesicles (OMV), aluminum hydroxide, sodium chloride, histidine, and sucrose.
15766780|NCT04722003|Other|Placebo|0.9% Sodium Chloride, USP injection.
15766781|NCT04721990|Device|Automatic Sound Management 3.0|The investigational front-end features include those within Automatic Sound Management 3.0 (i.e., Ambient Noise and Transient-Noise Reduction, and Adaptive Intelligence). Automatic Sound Management 3.0 will be accessed in the MAESTRO system software. The investigational front-end features within Automatic Sound Management 3.0 will be programmed in the SONNET2EAS processor.
15766785|NCT04721964|Dietary Supplement|Ferric ammonium citrate and ferrous fumarate syrup (Ranbaxy Ranferon-12 Syrup, Ranbaxy Laboratories, Gurgaon, India)|Daily supplementation with iron syrup for 13 weeks. The dosage will be calculated based on body weight and adjusted after 4 and 8 weeks of intervention
15766786|NCT04721951|Procedure|Endovascular Aortic Repair using Carbon Dioxide Angiography|Endovascular Aortic Repair using Carbon Dioxide Angiography
15766787|NCT04721938|Behavioral|Systematic weight loss intervention|"Weight reduction through life style changes in diet and exercise by the following means:
~Counselling with a Nutritionist Nurse on diet and exercise
~Online Smartphone coaching program (Life-sum App)
~Motivational and adjustment dialogue and counselling with Nutritionist Nurse including anthropometric measures every month"
15766788|NCT04721925|Behavioral|Social media messaging|A motivational interviewing-based intervention delivered via private health coaching on social media for 8 weeks.
15766789|NCT04721912|Drug|Probiotic dietary supplement|GBS positive patients, at ≥ 36 weeks gestation, will begin taking oral Florajen Digestion probiotic capsules once daily from time of enrollment/randomization at ≥ 36 weeks gestation until the time of birth.
15766790|NCT04721899|Dietary Supplement|Vitamin D|Vitamin D 50,000 IU once per week for 4 weeks, followed by 50,000 IU once every 2 weeks for 4 weeks
15766791|NCT04721886|Procedure|Ultrasonsgraphy|Undergo ultrasonography
15766792|NCT04721886|Drug|Perflutren Lipid Microcpheres|Given IV
15766793|NCT04721886|Procedure|Contrast - Enhanced Ultrasound|Undergo CEUS
15766794|NCT04721873|Drug|Phentermine-Topiramate|Patients will be randomized to either once-daily, oral phentermine-topiramate 15-92mg or placebo, in a 1:1 fashion, for 22 weeks, with clinic visits with an obesity medicine specialist, for intensive counseling for diet and lifestyle intervention. All patients will be dose-titrated within the first 4 weeks, starting at phentermine-topiramate 3.75-23mg, or placebo. Dose titration will be performed as follows 3.75-23mg x 1 week --> 7.5-46mg x 1 week --> 11.25-69mg x 1 week --> 15-92mg. Patients who experience side effects would undergo slower titration, and dose would be down-titrated and capped at highest tolerated dose.
15766795|NCT04721873|Drug|Placebo|Matching placebo, titrated as active intervention
15766796|NCT04721860|Behavioral|Backward Locomotion Treadmill Training (BLTT)|12-training sessions of reverse treadmill training (no bodyweight support) over four weeks.
15766797|NCT04721860|Behavioral|Forward Locomotion Treadmill Training (FLTT)|12-training sessions of forward treadmill training (no bodyweight support) over tfour weeks.
15766798|NCT04721847|Other|Pain Neuroscience Education|In first part educational content will be designed to be given in group of patients in six sessions by PNE booklet. The six sessions are 1.5 hours long (9 hours) and will be given at a frequency of 1 session per week. Final session will be given to solve doubts, and to provide additional information to the educational program. Book for additional material will be delivered to participants.
15766799|NCT04721847|Other|Conventional Physical therapy|Control group will be treated by Conventional Physical therapy like TENS, stretching and strengthening exercises. Intervention will be initiated with warm up period (joint mobility exercises) for the duration of 5 mins and ended up with cool down period (relaxing exercises i.e. deep breathing) for the duration of 5 mins.
15766800|NCT04721834|Device|Low-intensity Extracorporeal Shockwave Therapy|Low intensity shockwave energy would be delivered to stimulate angiogenesis in corporal tissue. Therapy would be delivered through a linear probe in 6 sessions. It would be conducted as a day procedure.
15766801|NCT04721834|Device|Sham Therapy|Same device as the active treatment arm would be used, with the addition of sham probe which block all shockwaves.
15766802|NCT04721821|Drug|Tofacitinib|Patients who received Tofacitinib for RA
15766803|NCT04721795|Drug|Atorvastatin with standard anti tuberculosis drugs|Participants will receive oral 30/40mg of atorvastatin daily for 2 months together with oral doses of standard antituberculosis drugs consisting of Rifampicin, INH, Ethambuthol and pyrazinamide for 2months. At the end of 2months, participants will continue with only standard anti tuberculosis drugs, Rifampicin and INH for 4months.Doseage of antituberculosis drugs are dependent on weight
15766804|NCT04721795|Drug|Anti tuberculosis drugs only|Participants will receive oral doses of standard antituberculosis drugs consisting of Rifampicin, INH, Ethambuthol and pyrazinamide for 2months. At the end of 2months, participants will continue with only standard anti tuberculosis drugs, Rifampicin and INH for 4months.Doseage of antituberculosis drugs are dependent on weight
15766805|NCT04721782|Other|smoking|to assess the effect of smoking of fetal liver circulation with prenatal Doppler Ultrasonography
15766806|NCT04721769|Procedure|Endoscopic strip craniectomy with post-operative helmet therapy|Endoscopic strip craniectomy is a surgical procedure performed to remove pathologic bone of the calvarium that includes the fused suture. Lateral osteotomies, also known as barrel-stave osteotomies, are performed by some surgeons because of their perceived benefit in regard to cranial expansion. Following surgery, orthotic helmet therapy is performed in order to mold the calvarium with the goals of optimizing contour.
15766807|NCT04721756|Drug|18F-LY3546117 Injection|370 megabecquerel (MBq) intravenous injection
15766808|NCT04721756|Procedure|PET Scan|positron emission tomography (PET) scan
15766809|NCT04721730|Behavioral|PLH-YC|There will be 5 weekly 2-hour sessions. The optimised PLH-YC uses a participatory, non-didactic approach to engage parents. Parents learn positive parenting skills and how to manage child behaviour problems. The program includes Session 1: One-on-One Time and Say What You See, Session 2: Praise and Rewards, Session 3: Instructions, Redirect, Rules, and Routines, Session 4: Ignore and Consequences, Session 5: Reflection and Moving On. Core activities during sessions include group discussions illustrated vignettes, role-plays, collaborative problem solving, practicing skills at home.
15766810|NCT04721730|Behavioral|Lecture|Lecture on parenting. This is a 26-slides power-point presentation that was developed by the University of Bremen for the purpose of this study. Duration: 1 to 1.5 hours. Content: 1) Stages of child development; (2) Potential risk factors for child emotional or behaviour problems; (3) Resources and protective factors; (4) Tips: What parents can do to promote children's development.
15766811|NCT04721704|Drug|Clarithromycin+ Amoxicillin + Omeprazole|In Group A: Amoxicillin AMO + Clarithromycin CLA + Proton pump inhibitor PPI will be given to children
15766812|NCT04721704|Drug|Metronidazole +Amoxicillin + Omeprazole|Group B: Amoxicillin AMO+ Metronidazole MET+ Proton pump inhibitor PPI
15766813|NCT04721691|Drug|Epidiolex 100 mg/mL Oral Solution|Epidiolex is a schedule 5 controlled substance that is a colorless to yellow oral liquid solution that is prepackaged into 100mL vials with 5mL syringes for use. It is typically used for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet Syndrome in patients 2 years of age and older.
15766814|NCT04721691|Other|Placebo|Placebo is composed of dehydrated alcohol, sesame seed oil, strawberry flavor, and sucralose.
15766815|NCT04721678|Behavioral|Interpersonal psychotherapy|Internet-based interpersonal psychotherapy aimed at reducing symptoms of depression. The content of the intervention is divided into three parts: the assessment phase (the first four weeks), the focus phase (the following five weeks), and the end phase (the last week).
15766816|NCT04721639|Other|Sphinx Yoga Therapy|Sphinx Pose Yoga is among the best beginner Yoga Poses that relieve Lower Back Pain. It extends the back gently and activates muscles along the spine. The subject will be asked to lay down on their stomach with feet set hip-width apart, the elbows positioned under the shoulders, and the legs held together. The chin should be pointing towards the floor. Next, the subject is required to pull up the kneecaps, squeezing the thighs and buttocks, pressing the pubic bone into the floor and dropping shoulders back away from the neck and pushing the chest forward. In this position, the subject is asked to breathe and hold the pose for two to six breaths. By the end, the subject will be required to exhale, bringing the elbows to the sides and slowly lowering the chest and head to the floor.
15766817|NCT04721626|Drug|Chlorhexidine Gluconate|"Preoperative: The patient's dentition, or mandibular alveolus in the absence of dentition, will be brushed for two minutes with 0.12% chlorhexidine gluconate.
~Intraoperative: The wound will be irrigated for 60 seconds with 0.05% chlorhexidine after it is irrigated with povidone-iodine.
~Postoperative: Patients will swish and spit/suction 15mL 0.12% Chlorhexidine Gluconate (CHG) oral rinses for 30 seconds every six hours for two days (8 total administrations)"
15766818|NCT04721626|Drug|Povidone-iodine|"Preoperative: The oral cavity and oropharyngeal mucosa as well as the nasal vestibules will be coated with 5% povidone-iodine which will stand for at least three minutes prior to incision.
~Intraoperative: The wound will be irrigated for 60 seconds with 10% povidone-iodine."
15766819|NCT04721626|Drug|Tetracycline Ointment|Postoperative: ~10g 3% tetracycline ointment will be placed into the oral cavity to coat the dorsal tongue and any oral suture lines every six hours for two days (8 total doses).
15766820|NCT04721613|Other|Assessment of Melatonin level|Measuring the plasma or serum melatonin in pg/ml during the first 24 hours after delirium diagnosis in two-hour intervals.
15766821|NCT04721600|Device|Evoke Radiofrequency Device|Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments.Treatment area will include face and under chin
15766822|NCT04721587|Device|Virtual Reality|"The patients of the VR Group will be subjected to the same hysteroscopy technique as the Standard of Care Group, but additionally a VR device will be applied where a distraction VR environment (Underwater Game) will be reproduced during the exploration"
15766823|NCT04721574|Device|Philips EnergyUp Energy light HF3418/01|high brightness LED light box
15766824|NCT04721574|Device|Philips EnergyUp Energy light HF3418/01 with filter|high brightness LED light box with filters that reduced lamp output to less than 50 lux
15766825|NCT04721548|Drug|Minoxidil Topical Foam|1 mL of solution twice a day.
15766826|NCT04721548|Drug|Placebo|1 mL of solution twice a day.
15766827|NCT04721535|Drug|DWJ1248|Orally, 1 tablet of DWJ1248 TID, up to 14 days
15766828|NCT04721535|Drug|Placebo|Orally, 1 tablet of placebo TID, up to 14 days
15766860|NCT04721249|Dietary Supplement|D-serine|Patients will receive four 500mg capsules of D-serine each day over a course of six weeks (two after breakfast and two after dinner).
15766829|NCT04721509|Device|Experimental : Smartphone-based telemedicine with the app 'Songaree diabetes'|Experimental group: outpatient clinic and offline education every 12 weeks plus telemedicine and education with smartphone app 'Songaree diabetes' every 2 weeks for 24 weeks
15766830|NCT04721496|Behavioral|Power and Speed|"Analysis of the power and speed of execution in 6 conditions of increasing instability Situation 1 is stable and basic execution. Condition 6 is the most unstable.
~The participants performed 2 series of 3 repetitions in each of the situations. All the exercises were executed on the same day."
15766831|NCT04721483|Procedure|Ramicotomy|We will selectively lesion the gray rami communicantes from T3 and T4 thoracic sympathetic ganglia
15766832|NCT04721470|Procedure|Combined therapy|Patients undergoing combined therapy
15766833|NCT04721470|Procedure|Microwave ablation|Patients undergoing Microwave ablation
15766834|NCT04721470|Procedure|Transarterial chemoembolization|Patients undergoing Transarterial chemoembolization
15766835|NCT04721457|Drug|Distilled Water|Distilled Water placebo rinse
15766836|NCT04721457|Drug|1% Povidone Iodine (PVP-I)|Over-the-counter antiseptic mouth rinse
15766837|NCT04721457|Drug|1.5% Hydrogen Peroxide (H2O2)|Over-the-counter antiseptic mouth rinse
15766838|NCT04721457|Drug|0.075% Cetylpyridinium Chloride (CPC)|Over-the-counter antiseptic mouth rinse
15766839|NCT04721457|Drug|0.1% Sodium Hypochlorite|Over-the-counter antiseptic mouth rinse
15766840|NCT04721444|Diagnostic Test|Machine Learning Classification of parenchymal lung change cause|Arms A & B: Radiomics and deep-learning approaches will be used on patient's imaging to develop a feature vector that can distinguish parenchymal lung changes, e.g. infection from drug-toxicity.
15766841|NCT04721444|Diagnostic Test|Machine Learning Classification of recurrence and non-recurrence|Arm C: Radiomics and deep-learning approaches will be used on patient's imaging to develop a risk-signature for recurrence of malignancy following radical treatment
15766842|NCT04721431|Diagnostic Test|Myotonometric assessment|MyotonPro device is vertically placed on the muscle, a probe (3 mm diameter) creates constant pre-excitations (0.18 N) and generates short-term (15 ms), low-force (0.4 N) mechanical stimulations.These stimulations induce damped natural oscillations in the tissue and the device records these oscillations using an accelerometer. Muscle tone, elasticity, and stiffness are calculated separately by the device
15766843|NCT04721418|Radiation|11C-UCB-J|11C-UCB-J PET scan
15766844|NCT04721405|Device|Observational Study: No intervention|Observational Study: No intervention
15766847|NCT04721379|Behavioral|Meditation|"Group 1 participants with unguided session simply close their eyes for 10 minutes while EEG and EKG recordings are performed. Following 10 minutes, after briefly opening their eyes, they will be asked to relax with eyes closed for 30 minutes. After finishing the session, they fill out meditation depth questionnaire.
~Group 2 participants with guided sessions close their eyes for 10 minutes while EEG and EKG recordings are performed. Following 10 minutes, after briefly opening their eyes, they will be guided through relaxation and meditation session for 30 minutes with a Heartfulness trainer with continued recording. After finishing the session, they also fill out meditation depth questionnaire."
15766848|NCT04721366|Other|Standard of Care|Neonatal and pediatric participants who has been on ERT (VPRIV) will be assessed as per SOC.
15766850|NCT04721340|Other|Test Group|Individuals who meet the inclusion criteria will be evaluated for manual dexterity, performance, muscle strength and fatigue, respectively, on a predetermined day.
15766851|NCT04721340|Other|Control Grup|Individuals who meet the inclusion criteria will be evaluated for manual dexterity, performance, muscle strength and fatigue, respectively, on a predetermined day.
15766852|NCT04721327|Other|remote CI programming|provision of CI programming provided remotely via Zoom in a 2 hour session
15766853|NCT04721314|Device|Adjustment of lower rate limit|Patients with preserved ejection fraction (EF >50%) and implanted pacemakers will have the lower rate limit adjusted to a personalized heart rate based on a heart rate algorithm.
15766854|NCT04721314|Device|Maintenance of lower rate limit|Lower rate limit will be maintained at 60 beats-per-minute
15766855|NCT04721301|Combination Product|Nivolumab plus Ipilimumab plus Maraviroc|In the single treatment arm, all patients receive Nivolumab, Ipilimumab and Maraviroc
15766856|NCT04721288|Other|Active communication through Reboot application|Access to active communication with the transplant care team through Reboot application based asynchronous messaging for non-urgent issues, as well as personalized clinical notifications.
15766857|NCT04721288|Other|Generic communication through Reboot application|Access to generic messaging through Reboot application, and communication with the transplant care team through standard of care communication system.
15766858|NCT04721275|Other|measurement of pronostic sepsis scores|qSOFA, NEWS and MEDS sores are measured to each patient admitted in the emergency department with a suspicion of infection (excluding localized infection as abscess, angina, cystitis).
15766859|NCT04721262|Device|Hyperfine Portable MRI|The Hyperfine device is a newly developed MRI unit that has multiple potential advantages over standard CT or MRI including portability, easier upkeep, open design, and ease of use. Unlike CT, the Hyperfine device does not use moving parts or X-rays to generate images. Unlike routine MRI, the Hyperfine device uses two permanent magnets with open space between and around them, rather than a super-cooled superconducting magnetic tube. In contrast to CT and routine MRI, the device can be wheeled from place to place and moved into position with the patient remaining on a gurney or hospital bed. Relative to routine MRI, the device uses a very low magnetic field strength of 64 mT compared to 1.5 T or 3 T, making it safer for patients or environments with medical devices having metallic components.
15766861|NCT04721249|Dietary Supplement|Placebo|Patients in the placebo group will receive four placebo capsules each day (two after breakfast and two after dinner). The placebo capsules will contain Mannotol / Mannitol-Silica (99.5/0.5, respectively) and will be indistinguishable from D-serine by matching colour, shape, size and packaging.
15766862|NCT04721236|Other|hyperimmune plasma|plasma collected from convalescent Covid-19 donors with titre 1:80 or more
15766863|NCT04721223|Drug|JAB-3068|JAB-3068 administrated orally as a tablet.
15766864|NCT04721223|Drug|PD1 inhibitor|JS001 administrated as an intravenous(IV) infusion.
15766865|NCT04721210|Other|Transcranial magnetic stimulation|"The investigated method is called transcranial magnetic The impact on the SMA will be made using a special inductor of the double conical coil type. Navigation will be carried out through the use of the international system 10-20%. The threshold of motor response will be determined by stimulating the motor area of the legs with the intensity of stimulation necessary to trigger a motor response with an amplitude of more than 50 mv."
15766868|NCT04721171|Device|The Bridge device|he Bridge device is a non-invasive percutaneous electrical nerve field stimulation (PENFS) applied to the external ear. The Bridge device delivers low voltage (3.2), continuous stimulation for 5 days (around the clock) in alternating frequencies (1-10Hz) with an impulse interval of 100ms/2 sec. This is placed on the ear as per standard protocol at the beginning of the study and removed by the patient after 5 days.
15766869|NCT04721158|Device|Continuous glucose monitor|Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.
15766870|NCT04721145|Device|Dexcom G6 Continuous Glucose Monitor|Eligible patients will have a Dexcom G6 Continuous Glucose Monitor placed for 10 days.
15766871|NCT04721132|Biological|Atezolizumab|Given IV
15766872|NCT04721132|Biological|Bevacizumab|Given IV
15766873|NCT04721132|Procedure|Therapeutic Conventional Surgery|Undergo surgery
15766874|NCT04721119|Procedure|Local Infiltration Anesthetic|For the local infiltration anesthetic, patients will receive 20 cc of 0.5% ropivacaine, by intra-articular injection performed by the surgeon. The injection is done at the end of the surgical procedure, after suturing the incision.
15766875|NCT04721119|Procedure|Local Infiltration Anesthetic + Adductor Canal Block|For the local infiltration anesthetic, patients will receive 20 cc of 0.25% ropivacaine, by intra-articular injection performed by the surgeon. The injection is done at the end of the surgical procedure, after suturing the incision. For the adductor canal block, patients will receive 20 cc of 0.25% ropivicaine, through injection performed by the anesthesiologist. The injection is done under the sartorius muscle, in mid-thigh, using ultrasound guidance.
15766876|NCT04721106|Drug|Vizimpro|treatment group
15766877|NCT04721093|Device|Photobiomodulation device|In this study, PBM was applied using a machine made to be attached to the subject in the form of a probe. In this clinical trial, a low-intensity irradiation device (Color-DNA-WSF U) from Color seven was used to deliver visible light (610nm± 10nm wavelength, 3.0mW/㎠±20%) irradiation. PBM was applied 5 times a week for 8 weeks, 30 minutes per session.
15766878|NCT04721080|Other|Functional Outcome Measurements|Dyspnea Exercise capacity Quality of life assessment
15766879|NCT04721067|Device|SHUTi|SHUTi is the empirically supported, internet CBT-I that is fully accessible via tablets and smartphones. It uses a self-guided, fully automated, interactive, multimedia format to deliver six 45-minute sessions, the structure and content of which mirror traditional face-to-face CBT-I. Session content includes sleep restriction, stimulus control, sleep hygiene, cognitive restructuring, and relapse prevention. SHUTi is enhanced through a variety of interactive features, including personalized goal setting, graphical feedback based on inputted symptoms, animations and illustrations to enhance comprehension, quizzes to test user knowledge, patient vignettes, and video-based expert explanation. Across sessions, patients also receive tailored sleep recommendations and feedback based on the sleep diary data they enter into the program.
15766880|NCT04721067|Behavioral|Sleep Education/Hygiene|A research assistant (RA) will deliver the active control procedures. During the first 4 weeks, the RA will have two calls with each control participant - one 45-minute call on insomnia education (including their HIV provider's role in its management) and one 45-minute call on sleep hygiene practices. To end the first call, the RA will email or mail a list of local behavioral health services to patients and will encourage them to follow-up with their HIV provider. We will then notify the HIV provider, which will encourage them to address their patient's insomnia and provide the same list of local services.
15766881|NCT04721054|Drug|Thoracic epidural effect on heart rate in Laparoscopic Cholecystectomy (bupivacaine and lignocaine)|patients in epidural anesthesia were given epidural anesthesia and assessed for heart rate and mean arterial pressure
15766882|NCT04721054|Drug|general anesthesia effect on heart rate in Laparoscopic Cholecystectomy|patients in general anesthesia were given epidural anesthesia and assessed for heart rate and mean arterial pressure
15766883|NCT04721041|Procedure|Washed Microbiota Transplantation (WMT)|Washed microbiota suspension (5u) delivered through nasogastric tube, nasojejunal tube or oral. Dose and frequency: 5u, three times.
15766884|NCT04721028|Device|Human body component analyzer|The body composition analyzer is a kind of instrument that can measure the body composition health index. It is composed of professional tester, professional consulting management software, color printer A/B machine and so on.
15766888|NCT04720989|Procedure|Bathing With Baby Cleanser and water|Late preterm and term newborns, whose informed consents are obtained by their parents to participate in the project, will be given their first baths according to the intervention group they are assigned to. Before the first bath / after birth, preterm newborns in all groups will be wiped only once with a clean towel without removing the vernix caseosa. Newborns who were bathed before the application of the study will be excluded from the study. As the most appropriate time for bath time, 30 minutes after the end of the feeding and treatment of the newborns, the bath application will be made at any time between 9 pm and 3 pm.
15766889|NCT04720989|Procedure|Bathing With only Water|Preterm infants will have their first baths only with water.
15766890|NCT04720976|Drug|JAB-3312|JAB-3312 will be administered orally, variable dose.
15766891|NCT04720976|Drug|Binimetinib|Binimetinib will be administered orally.
15766892|NCT04720976|Drug|Pembrolizumab|Pembrolizumab will be administered as an intravenous infusion.
15766893|NCT04720963|Drug|Remimazolam|intranasal remimazolam
15766894|NCT04720963|Other|Distilled water for injection|intranasal distilled water for injection
15766895|NCT04720950|Other|Exercise|1 hour of exercise on a motorised treadmill at 70% maximal heart rate
15766896|NCT04720924|Device|Computer-aided Real-time Automatic Quality-control System|EGD automatic quality-control system(AQCS),developed based on deep convolutional neural network (DCNN) models,could facilitate real-time detection of upper gastrointestinal lesions, assess inspection completeness and mucosal visibility, and calculate time of EGD procedure.
15766897|NCT04720911|Behavioral|In-person TASCS|In-person clinician delivery of the intervention, including the Safety Planning Intervention, connection to best-match behavioral health resources, and development of an outpatient treatment plan by a research clinician, facilitated by the TASCS Clinician App.
15766898|NCT04720911|Behavioral|Telehealth TASCS|Telehealth clinician delivery of the intervention, including the Safety Planning Intervention, connection to best-match behavioral health resources, and development of an outpatient treatment plan by a research clinician, facilitated by the TASCS Clinician App.
15766899|NCT04720911|Behavioral|Self-administered TASCS|Self-administration of the intervention, including the Safety Planning Intervention, facilitated by the TASCS ED Patient App.
15766900|NCT04720911|Behavioral|Follow-up care|Counseling calls and access to the Post-ED Patient and Family App for three months after the index presentation. These resources allow the patient and family to review their safety plan, life plan, and outpatient care plan
15766901|NCT04720898|Device|LUNA-EMG|The LUNA-EMG (Samcom) system is a robot that allows the evaluation of muscular strength through the recording of muscle activity (electromyography - EMG) in order to provide precise objective data on the patient's muscle function. In addition to the diagnostic aspect (evaluation of muscle strength, range of motion and proprioception), the LUNA-EMG robot provides optimized range of motion's movements and a visual feedback on the patient's performance. In addition, it may enhance neuroplasticity due to the increased number of movements repetitions which could influence motor learning.
15766902|NCT04720885|Procedure|kind of surgery|hysteroscopy, curettage, other
15766903|NCT04720872|Other|Manual therapy and vestibular rehabilitation treatment|The experimental group received manual therapy and vestibular rehabilitation treatment.
15766904|NCT04720859|Drug|Canagliflozin 300 MG Oral Tablet|Patients diagnosed with PHH following bariatric surgery by 100g glucose OGTT were prescribed 300mg canagliflozin during two weeks. 100g glucose OGTT response was evaluated after canagliflozin treatment.
15766905|NCT04720846|Other|Matrix-based physical therapy|Matrix-based physical therapy will be physical therapy that is based on the matrix categorization of the patient (stiff vs. mobile hips, weak vs. strong hips) and involves instructions on the amount of time that should be spent doing stretching and strengthening therapy.
15766906|NCT04720846|Other|Standard-of-care physical therapy|Physical therapy that is being conducted as standard-of-care
15766907|NCT04720833|Dietary Supplement|dried plum|Dried plum
15766908|NCT04720833|Dietary Supplement|Calcium and vitamin D|Calcium and vitamin D supplement
15766909|NCT04720820|Other|Early Supported discharge with home based Rehabilitation|Treatment by Physiotherapist and occupational therapist at least 30 minutes each, per week provided at home.
15766910|NCT04720820|Other|Conventional rehabilitation|Treatment will be provided according to current hospital's stroke rehabilitation program.
15766911|NCT04720807|Drug|Letrozole combined with anlotinib hydrochloride|Letrozole combined with anlotinib hydrochloride in the treatment of platinum-resistant recurrent ovarian cancer.
15766912|NCT04720794|Device|Lucira COVID-19 All-In-One test kit|"The Lucira COVID-19 All-In-One Test Kit is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 in nasal swab samples. This test is a single-use test kit that determines whether there is active shedding of the virus which causes COVID-19. This test utilizes a molecular amplification technology for the detection of SARS-CoV-2 RNA.
~Positive results are indicative of active infection with SARS-CoV-2. Persons who test positive should self-isolate and seek care from their healthcare provider.
~Negative results do not preclude SARS-CoV-2 infection. Persons who continue to experience COVID-like symptoms should seek follow up care from their healthcare provider"
15766913|NCT04720781|Drug|Vonoprazan|Vonoprazan (20mg/day) is prescribed for 4 weeks.
15766914|NCT04720781|Drug|Esomeprazole|esomeprazole (20mg/day)
15766915|NCT04720768|Drug|Binimetinib|MEK inhibitor
15766916|NCT04720768|Drug|Encorafenib|BRAF inhibitor
15766917|NCT04720768|Drug|Palbociclib|CDK4/6 inhibitor
15766918|NCT04720755|Device|Low-Intensity Extracorporeal Shock Wave Therapy|Twice-weekly treatments for 6 weeks, of 0.2mL/mm^2 administered for 500 shocks per treatment site, for a total of 3000 shocks per week.
15766919|NCT04720742|Drug|Analytical Treatment Interruption + bNAbs infusion|The participant will perform an Analytical Treatment Interruption (ATI) of up to 18 months of duration. During the first 8 months, the participants will be infused once per month with a combination of the broadly neutralizing antibodies (bNAbs) 3BNC117 and 10-1074
15766921|NCT04720716|Drug|IBI310|IBI310 IV d1, Q3W for up to 4 cycles
15766922|NCT04720716|Drug|Sintilimab|sintilimab IV d1, Q3W
15766923|NCT04720716|Drug|Sorafenib|Sorafenib 400mg po
15766924|NCT04720703|Behavioral|Newsletters|Similar to prior empirical pediatric obesity interventions (Elder et al., 2009), the active attention waitlist control group will receive monthly newsletters that focus on physical activity, healthy eating, and screen time. These newsletters will be based on standard materials from the We Can program of the National Heart, Lung, and Blood Institute (NHLBI).
15766925|NCT04720703|Behavioral|Family-based Telehealth Intervention|All communications related to the intervention will occur through weekly small group video conferencing calls via Zoom and emails or text messages. The intervention will include diverse topics proven effective in prior interventions (Davis et al., 2019; McLean et al., 2003), including reading food labels, eating out, eating at social gatherings, sticker charts, praising/rewarding healthy choices, healthy foods available at home, portion sizes, healthy/easy/low-cost cooking ideas, goal setting, monitoring screen time, exercise opportunities available in neighborhood, family exercise ideas, and healthy sleep. The research team will also send relevant video/audio clips, brochures, reminders (text messages and emails) every week.
15766926|NCT04720690|Device|Vicorder: pulse wave velocity, pulse wave analysis, stroke volume, cardiac output|Measurement of arterial stiffness and cardiac output
15766927|NCT04720690|Device|NICaS|Measurement of cardiac output
15766928|NCT04720690|Device|Echocardiography and ultrasound of arteries|Measurement of cardiac output; measurement of intima-media thickness of arteries
15766929|NCT04720677|Other|Turkish Version of The Italian Spine Youth Quality of Life (ISYQOL) Questionnaire|Turkish Version of The Italian Spine Youth Quality of Life (ISYQOL) Questionnaire
15766931|NCT04720638|Other|Short fiber reinforced flowable resin composite restorations|reinforced flowable resin composite
15766932|NCT04720638|Other|Conventional resin composite restoration|Microhybrid resin composite
15766933|NCT04720625|Behavioral|Adapt2Quit|Motivational text messages and quitline facilitation text messages will be sent to participants; these participants will receive Adapt2Quit (experimental) messages as well as quitline facilitation messages.
15766934|NCT04720625|Behavioral|Control|Quitline facilitation text messages will be sent to participants; these participants will receive quitline facilitation-only messages.
15766937|NCT04720599|Diagnostic Test|ExoDx Prostate(IntelliScore)|The ExoDx Prostate test result supports the biopsy decision process by stratifying patients based on risk for high grade prostate cancer
15766938|NCT04720586|Procedure|lower eyelid blepharoplasty , retractor plication and wedge resection|combined lower eyelid blepharoplasty , retractor plication and wedge resection
15766939|NCT04720586|Procedure|lower eyelid blepharoplasty and retractor plication|combined lower eyelid blepharoplasty and retractor plication procedures
15766940|NCT04720573|Drug|Neostigmine|50 mcg/kg neostigmine was used under the guidance of TOF monitoring after cessation of anesthesia.
15766941|NCT04720573|Drug|Sugammadex|2 mg/kg sugammadex was used under the guidance of TOF monitoring after cessation of anesthesia.
15766942|NCT04720560|Diagnostic Test|regulatory B cell by flow cytometry|"4-Evaluation of the Frequency of regulatory B cells (Bregs) by Flow Cytometry Using flow cytometry, circulating Bregs will be detected using FITC-conjugated-CD38, PE-conjugated-CD24 (Bioscience, USA), and PerCP-conjugated CD19 (BD Bioscience, USA). Briefly, 100 µl of blood sample will be incubated with 10 µL of CD24, CD38 and CD19 for 20 minutes at 4 °C in the dark. Following incubation, RBCs will be lysed and washed. Cells will be fixed and permeabilized then stained with APC-conjugated IL-10 (BD Bioscience, San Jose, CA, USA) and analysis will be done by FACS Calibur flow cytometry with CellQuest software (Becton Dickinson Biosciences, San Jose, CA, USA).
~An isotype-matched negative control will be used for each sample. Forward and side scatter histograms will be used to define the lymphocytes population. CD19+ IL-10+ B cells will be gated, then the expression of CD38 and CD24 on the CD19+B cells will be detected. Bregs will be identified as CD19+ IL-10+CD24+hiCD38+hi cells."
15766943|NCT04720547|Drug|Zolpidem|A nonbenzodiazepine hypnotic
15766944|NCT04720534|Drug|ARO-APOC3|2 doses of ARO-APOC3 by subcutaneous (sc) injection
15766945|NCT04720534|Drug|Placebo|calculated volume to match active treatment by sc injection
15766946|NCT04720521|Diagnostic Test|OE+white light|Firstly use white light to observe from esophagus to duodenum and then switch OE mode to observe from antrum to esophagus
15766947|NCT04720508|Diagnostic Test|blood sample collection.|venipuncture procedure
15766948|NCT04720495|Procedure|One stage ridge splitting with simultaneous implant placement|"A full mucoperiosteal flap was raised using the sharp periosteal elevator to expose the bone crestally and buccally.
~An inverted U-shaped bone cut, down to the cancellous bone, was done in the undercut area with a piezoelectric device.
~The horizontal bone cut was made apical to the most concave point in the undercut area with a distance of 3 mm.
~The two vertical bone cuts were placed at least 1 mm away from the adjacent roots and extended beyond the undercut area.
~The released bone end was minimally elevated using a periosteotome through a greenstick fracture.
~All implants were installed with the implant shoulders flush to the bone level using a low-speed drilling procedure."
15766949|NCT04720495|Procedure|Two-stage ridge splitting with implant placement|"The first surgery is the same as one stage ridge splitting Four weeks later, after revascularization between the bone block and the mucoperiosteum, the second surgery will be performed.
~A crestal incision was done and the envelope flap slightly elevated to preserve the blood supply.
~The implants will be placed in the same manner as one stage ridge splitting"
15766950|NCT04720482|Diagnostic Test|Somatosensory Evoked Potentials|SSEP performed bilaterally with stimulation of the median nerve
15766951|NCT04720482|Diagnostic Test|Automated Pupillometry|PLR quantified as NPi using a handheld automated pupillometer
15766952|NCT04720469|Device|MRgFUS thalamotomy|Ablation of untreated thalamus using focused ultrasound to abate tremor.
15766955|NCT04720443|Drug|NIP292 tablet|NIP292 (oral tablet at 10 mg) or placebo
15766956|NCT04720443|Drug|NIP292 tablet|NIP292 (oral tablet at 30 mg) or placebo
15766957|NCT04720443|Drug|NIP292 tablet|NIP292 (oral tablet at 100 mg) or placebo
15766958|NCT04720443|Drug|NIP292 tablet|NIP292 (oral tablet at 300 mg) or placebo
15766959|NCT04720443|Drug|NIP292 tablet|NIP292 (oral tablet at 600 mg) or placebo
15766960|NCT04720443|Drug|NIP292 tablet|NIP292 (oral tablet at 900 mg) or placebo
15766961|NCT04720443|Drug|NIP292 tablets|NIP292 (oral tablet at dosage TBD) or placebo
15766962|NCT04720443|Drug|NIP292 tablets|NIP292 (oral tablet at dosage TBD) or placebo
15766963|NCT04720443|Drug|NIP292 tablets|NIP292 (oral tablet at dosage TBD) or placebo
15766964|NCT04720417|Drug|Defactinib Hydrochloride|Given PO
15766965|NCT04720417|Drug|Raf/MEK Inhibitor VS-6766|Given PO
15766966|NCT04720404|Behavioral|Mindfulness-Based Stress Reduction|Participants in the intervention group will follow a 4-week adapted MBSR training. The training consists of biweekly sessions of 1,5 hours. The training is structured based on the Mindfulness-Based Stress Reduction training as originally designed by John Kabat Zinn. The program includes both formal and informal meditation exercises.
15766967|NCT04720404|Other|Self-help mindfulness/compassion exercises|Participants in the self-help group will receive a 4-week program with daily suggestions for mindfulness/compassion exercises of 30 minutes on a YouTube-channel. Participants can schedule the exercises themselves.
15766968|NCT04720404|Other|Support as usual|Support as usual (SAU) consists of facilities or interventions already available healthcare organisations provided to their healthcare workers (e.g. buddy-, team- and peer support system, shopping/dinner service etc.).
15766969|NCT04720378|Biological|ST266|1X ST266
15766970|NCT04720365|Device|play-based rehabilitaion|usual re-education treatment by their physiotherapist
15766971|NCT04720352|Device|Active treatment|Active treatment delivers radiofrequency and cryogen
15766972|NCT04720352|Device|Sham|Sham delivers non therapeutic levels of radiofrequency and cryogen
15766973|NCT04720339|Genetic|Molecular monitoring by quantification of cell-free DNA|"Molecular monitoring by quantification of cell-free DNA (absolute value and variation from baseline) of two house-keeping genes (RPP30, ASL) by droplet digital PCR, during based-immunotherapy treatments of NSCLC patients.
~Cell-free DNA will be extracted from 4 ml of plasma before treatments by immunotherapy, obtained from blood Streck® tubes.
~Quantification of house-keeping genes (or mutated genes if some are previously routinely identified in tumor tissue) by ddPCR."
15766974|NCT04720326|Drug|Tacrolimus Pill|Envarsus® tablets dosed to achieve and maintain whole blood trough levels of tacrolimus within a patient-specific therapeutic range (interval of 3 ng/ml) that lies within a wider reference range of 3-12 ng/ml.
15766975|NCT04720326|Drug|Tacrolimus capsule|Advagraf® capsules dosed to achieve and maintain whole blood trough levels of tacrolimus within a patient-specific therapeutic range (interval of 3 ng/ml) that lies within a wider reference range of 3-12 ng/ml.
15766976|NCT04720313|Drug|CART BCMA|HBI0101 CART is defined as autologous T cells transduced ex-vivo with anti-BCMA CAR retroviral vector encoding the chimeric antigen receptor (CAR) targeted to human BCMA. The HBI0101 CART is provided fresh without cryopreservation.
15766977|NCT04720300|Other|MaaS app|The MaaS App will be downloaded to students' smartphones and will provide real-time, multimodal trip planning to students on demand when they open the app.
15766978|NCT04720300|Other|No app|students receive no app or housing information
15766979|NCT04720287|Drug|bupivacaine/ neostigmine.|will receive bilateral ultrasound guided QLB
15766980|NCT04720287|Drug|bupivacaine/ neostigmine.|will receive ultrasound guided CB.
15766981|NCT04720274|Device|Electromyopathy (EMG) Shorts|Participants will be asked to complete physical activities while wearing EMG shorts
15766982|NCT04720261|Drug|Caplacizumab|Analyse of ADAMTS13 activity in patients with aTTP treated with Caplacizumab in order to help adapting the treatment with caplacizumab in TTP patients
15766983|NCT04720248|Drug|Metamizole|Patients will receive metamizole intraoperatively and throughout 48h postoperatively.
15766984|NCT04720235|Device|Lucira COVID-19 All-In-One test kit|"The Lucira COVID-19 All-In-One Test Kit is intended to detect the novel coronavirus SARS-CoV-2 that causes COVID-19 in nasal swab samples. This test is a single-use test kit that determines whether there is active shedding of the virus which causes COVID-19. This test utilizes a molecular amplification technology for the detection of SARS-CoV-2 RNA.
~Positive results are indicative of active infection with SARS-CoV-2. Persons who test positive should self-isolate and seek care from their healthcare provider.
~Negative results do not preclude SARS-CoV-2 infection. Persons who continue to experience COVID-like symptoms should seek follow up care from their healthcare provider"
15766985|NCT04720222|Device|TENA-PROTO1|Each volunteer will test the TENA-PROTO1 according to a standardized protocol in multiple postural positions to evaluate the detectability of the bladder by help of the investigational device
15766986|NCT04720209|Other|CARE|CARE is a 16-week, supervised, periodized AE and RE program performed in a circuit fashion 3 days/week (2 days mandatory on-site, 1 day with the option of completion on-site or at home)
15766987|NCT04720209|Other|TARE|TARE is a 16- week, supervised AE and RE program consisting of three sessions per week (2 mandatory on-site and 1 with option to complete on-site or at home),
15766988|NCT04720209|Other|Home-Based Stretching|This group will perform a home-based program of the same stretches utilized in the CARE and TARE groups.
15766989|NCT04720196|Device|Active repetitive transcranial magnetic stimulation|High frequency rTMS over the primary motor area to induce the long term potentiation of primary motor areas for the muscles of upper extremity.
15766990|NCT04720196|Device|Sham repetitive transcranial magnetic stimulation|Sham stimulation to mimic the high frequency rTMS over the primary motor area.
15766991|NCT04720183|Drug|Sulfasalazine|On Day 1, Day 5 and Day 9, a single oral dose of sulfasalazine tablets in fasted state.
15766992|NCT04720183|Drug|GLPG3970|On Day 5 and Day 9, a single dose of GLPG3970 oral solution in fasted state.
15766993|NCT04720170|Procedure|Revascularization|Angiogram and IVUS with revascularization of the lateral plantar artery and pedal arch on target foot.
15766998|NCT04720131|Drug|Camrelizumab|Camrelizumab was administered 200mg iv every 3 weeks.
15766999|NCT04720131|Drug|apatinib|"Apatinib A safety-run-in was conducted in the first cycle to identify the recommended dose of Apatinib, the initial dose was administered 250mg orally daily every 3 weeks (Day 1-14 of a treatment cycle) The dose of Apatinib increase and reduction was 250 mg orally q.d. and 250 mg orally q.o.d. every 3 weeks respectively according to the number of doses limiting toxicity events (DLTs) in the initial group.
~The final dose of Apatinib for the extension stage was detemained by the result of safety-run-in stage."
15767000|NCT04720131|Drug|Capecitabine|Capecitabine was administered 1000mg/m2 orally, b.i.d. every 3 weeks (Day 1-14 of a treatment cycle)
15767001|NCT04720118|Other|No Intervention|There is no intervention for this study.
15767002|NCT04720105|Drug|Duobrii®|Duobrii® (halobetasol propionate 0.01%/tazarotene 0.045% lotion, HP/TAZ) will be provided at weeks 0,2,8,16 for a total of 24 weeks.
15767003|NCT04720092|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Granules for oral suspension, 10 mg, oral, single dose
15767004|NCT04720092|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Tablet, 10 mg, oral, single dose
15767005|NCT04720079|Procedure|Subcutaneous infiltration of intercostobrachial nerve|Preoperative subcutaneous infiltration of intercostobrachial nerve with 10ml of 0.5% ropivacaine
15767006|NCT04720079|Procedure|T2 paravertebral nerve block|Preoperative ultrasound guided T2 paravertebral nerve block with 10ml of 0.5% ropivacaine
15767008|NCT04720053|Device|Wearable brain sensing wellness device headband system|Brain sensing headband that measures brain activity by detecting electrical impulses created by the brain.
15767009|NCT04720040|Device|Mind STIM|transcranial Direct Current Stimulation (tDCS) 2mA for 30 min; 30 sec of ramp-up and -down; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)
15767010|NCT04720027|Diagnostic Test|Duplex imaging|Completion of AVVQ and EQ5D questionnairs
15767011|NCT04720014|Behavioral|SMART-3RP Group Intervention|"Nine 1.5 hour group sessions focusing on developing:
~an understanding of stress physiology and the physiology of the relaxation response;
~a regular practice of eliciting the relaxation response; and
~cognitive behavioral and positive psychology/resilience skills.
~Participants receive a copy of the SMART-3RP session manual and audio recorded guided meditations for independent relaxation practice. Participants are encouraged to practice eliciting the relaxation response daily throughout the study, using the audio recordings or other mind body techniques. Participants will use a practice log to track their practice."
15767012|NCT04720001|Drug|Florbetaben F18|A single injection of 8.1mCi of florbetaben F18 will be administered by intravenous bolus injection
15767013|NCT04720001|Device|PET|PET Scan for brain imaging
15767014|NCT04719988|Biological|Blood sample collection|"A total of 9 EDTA (ethylenediaminetetraacetic acid) tubes will be collected at each time point to perform:
~PBMC collection: 6 EDTA tubes of 6 ml of peripheral blood mononuclear cell [PBMC] will be sent to the central laboratory (Biomonitoring Platform of Besançon, CHRU de Besançon located at Etablissement Français du Sang) at room temperature within 24 hours via an approved carrier for their processing, storage and immunomonitoring analysis. A sending sheet of the samples will be attached to each single sample.
~Plasma collection: One 6 ml EDTA tube should be frozen in each investigation center for plasma collection.
~Plasma for circulating tumoral DNA (ctDNA) collection: Two 4 ml EDTA tube should be frozen in each investigation center for ctDNA collection."
15767015|NCT04719988|Procedure|Biopsy|A tumor biopsy will be performed at 2 months after enrollment.
15767016|NCT04719975|Other|Mental Fatigue (Stroop task)|"A modified Stroop task of approximately 60 min will be used in order to induce mental fatigue (MF). This will be based on their performance during the max test that was conducted during the familiarization session. In this task, which will be partitioned in 4 blocks of 468 stimuli, four colored words (rood, blauw, groen and geel) will be presented one at a time on a computer screen. The participants will be required to indicate the color of the word, ignoring the meaning of the word itself."
15767017|NCT04719975|Other|Control (Documentary)|In the control task subjects will have to watch a documentary of 60 min on the same computer screen as the one used for the experimental trial. In order to avoid under- and over-arousal the subjects will have the opportunity to choose between several documentaries as proposed by the research team. During the control task physiological and psychological measures will be assessed at the same time points as during the mental fatigue trial.
15767018|NCT04719962|Procedure|Targeted proteomics in skin +/- cerebrospinal or synovial fluid to diagnose disseminated Lyme disease|"Following a 2-days course of local daily clobetasol propionate 0,05% cream application, a skin biopsy (3 mm punch-biopsy ) of healthy-looking skin of the upper part of the thigh will be performed in all patients,.
~Arthrocentesis (in patients with Lyme arthritis only) and lumbar puncture to collect cerebrospinal fluid (in patients with neuroborreliosis only) will be performed in the usual care setting as appropriated.
~All biological samples will be subject to Borrelia culture, PCR and SRM-MS proteomics."
15767019|NCT04719949|Behavioral|Behavioral Activation (BA) Therapy|Brief BA is a manualized individual psychotherapy adapted to a four-session structure for this pilot study. The first session provides psychoeducation about the value and reinforcement of various behaviors and treatment rationale. Three additional sessions include reviewing the youth's log of the activities they planned each week, assessing youths' values and planning further valued activities, and reviewing progress.
15767020|NCT04719949|Behavioral|Problem Solving Therapy (PST)|Brief PST is a manualized individual psychotherapy adapted to a four-session structure for this study. The first session provides psychoeducation on links between mood and managing social problems, as well as defining and identifying individual problems. Three additional sessions focus on generating solutions, decision making, implementing solutions, and evaluation and assessment of the outcomes of these solutions.
15767021|NCT04719936|Procedure|inferior capsulotomy|inferior capsulotomy will be conducted during posterior approach.
15767022|NCT04719936|Procedure|superior capsulotomy|superior capsulotomy will be conducted during posterior approach.
15767023|NCT04719923|Behavioral|Children with autism spectrum disorders|Subjects affected by autism spectrum disorders
15767024|NCT04719910|Other|Visual exposure to taped food preparation|Patients in the study group can watch the preparation of the the type of food she prefers to eat normally.
15767025|NCT04719910|Other|Visual exposure to topics not related to food|Patients in the placebo group can choose a video that is relaxing but not related to food.
15767026|NCT04719897|Behavioral|FIRST: Repairing Thoughts|"This intervention uses the Repairing Thoughts cognitive restructuring module of the FIRST (Feeling Calm, Increasing Motivation, Repairing Thoughts, Solving Problems, Trying the Opposite) cognitive behavioral therapy protocol. This psychotherapy module teaches adolescents that thoughts are linked to feelings and behaviors, and that thoughts are often guesses to interpreting the world around us. Adolescents are taught to notice their thoughts in real-time and evaluate the evidence that supports or contradicts the thoughts and interpretation. Adolescents are then taught strategies to re-interpret thoughts in a more realistic manner and notice changes in emotional and behavioral responses. Clinicians are provided with examples to enhance learning, and between-session practice is assigned as homework."
15767027|NCT04719884|Procedure|Perioperative fluid optimisation|"In case of stroke volume variation (SVV) >10% and SI and CI >10% below the starting value, fluid challenge was performed with approximately 2 ml/kg of colloid over maximum of 5 minutes. The response was monitored.
~If there was a fall in SVV and an increase in SI of >10% and the SVV still >10%, the second fluid challenge was performed.
~If there was still a reduction in SVV after the second fluid challenge, but an increase in nSI <10% and decrease in systemic vascular resistance (SVR), no additional fluids were given. Vasoactive drugs were used instead."
15767028|NCT04719858|Behavioral|#LIFEGOALS|"Digital health behaviour change intervention including:
~self-regulation component with Fitbit: goal setting, monitoring, feedback;
~narrative component: every week participants receive a new episode (2-5 minutes) of a youth series modeling the target behaviours;
~chatbot component: automated virtual coach that will send encouraging messages and give an automated answer to user questions.
~Participants install the #LIFEGOALS app on their own mobile phone and are asked to use the app during 12 consecutive weeks. Three times per week a notification will be sent to encourage engagement with the intervention."
15767029|NCT04719845|Procedure|Endoscopic laser resection|Laser resection
15767030|NCT04719845|Procedure|Dilatation|Dilatation
15767031|NCT04719832|Biological|GSK3511294 (Depemokimab)|GSK3511294 (Depemokimab) will be administered.
15767032|NCT04719832|Drug|Placebo|Matching placebo will be administered.
15767033|NCT04719832|Drug|Standard of care|SoC will include ICS plus at least one other controller, Long-acting beta-agonist (LABA), Long-acting muscarinic antagonist (LAMA), with or without maintenance oral corticosteroids (OCS).
15767034|NCT04719832|Device|Pre-filled Syringe|Pre-filled syringe will include glass barrel with pre-staked needle and plunger.
15767035|NCT04719819|Procedure|Spinal anaesthesia for caesarean section|Descriptive questionnaire with open and closed questions, to be completed during the procedure
15767036|NCT04719793|Biological|Umbilical Cord-derived Wharton's Jelly|Intraarticular injection
15767037|NCT04719780|Behavioral|Emotionally Focused Therapy for Individuals|Emotionally Focused Therapy for Individuals (EFIT) is formulated as a transdiagnostic treatment to treat depression and anxiety, adapted from the well-studied Emotionally Focused Therapy. EFIT has been formulated as an attachment-based alternative to current cognitive approaches (e.g., Cognitive Behavioural Therapy). The strong evidence for insecure attachment as an underlying factor in psychopathology, especially depression and anxiety, positions this theory well as a foundational principle to support psychotherapy for these conditions.
15767038|NCT04719780|Behavioral|Self-Help CBT Training|Individuals in the Waitlist Control Group will receive access to MoodGym, a self-help online program that helps teach CBT interventions. This access will last 15 weeks and is self-driven, meaning participants proceed through the program at their own pace.
15767039|NCT04719767|Device|visual laryngeal mask|After anesthesia induction, visual laryngeal mask airway was placed in the visual group and tracheal intubation was guided under visual conditions. In the non-visual group, laryngeal mask airway was inserted, after clinical judgment of good counterpoint of the laryngeal mask, endotracheal intubation was inserted blindly through LMA. Selection of laryngeal mask airway (LMA) model: the ideal body weight of the patient was calculated.
15767040|NCT04719754|Diagnostic Test|Vaginal swab|The other vaginal swab will be cultured on blood agar, chocolate agar, MacConkey agar and Sabourauds dextrose agar. The cultures will be incubated at 37ºC for 24-96 h or until the colonies appear.
15767041|NCT04719741|Other|Parallel Assignment|Prospective, Triple blinded, randomized, controlled trial
15767042|NCT04719728|Diagnostic Test|Aided pure tone audiometry|aided response, speech, evoked potential
15767043|NCT04719715|Diagnostic Test|Indirect immunofluorescence (IIF) , myeloperoxidase antibody(MPO)- and anti-proteinase 3 (PR3-) ANCA immunoassays|Measurement and evaluation of the ANCA testing
15767044|NCT04719689|Other|Dry needling|Experimental group 1 got this intervention containing Dry needling for 10 mins, followed by conventional physiotherapy treatment (hot pack and stretching) for 15 mins. Participants were treated 6 times over a 3 week period with 2 treatment sessions per week per patient. Pre and Post treatment readings were taken in 1st and 6th session over a 3 week period respectively. A follow up reading was also taken after 1 month for checking prolonged post treatment effects. Assessment was done via Pressure pain threshold Scale, Pelvic goniometer and Measuring tape for assessing functional positional fault of pelvis and muscle length of Quadratus lumborum
15767045|NCT04719689|Other|Dry cupping|Experimental group 2 got this intervention containing Dry cupping for 10 mins, followed by conventional physiotherapy treatment (hot pack and stretching) for 15 mins. Participants were treated 6 times over a 3 week period with 2 treatment sessions per week per patient. Pre and Post treatment readings were taken in 1st and 6th session over a 3 week period respectively. A follow up reading was also taken after 1 month for checking prolonged post treatment effects. Assessment was done via Pressure pain threshold Scale, Pelvic goniometer and Measuring tape for assessing functional positional fault of pelvis and muscle length of Quadratus Lumborum
15767046|NCT04719676|Other|Core strength training using unstable surface|"Training would include big 3 exercises as described by McGill. These include the curl-up, side bridge, and quadruped position on unstable surface"
15767047|NCT04719676|Other|The stable surface would be gym floor.|"Training would include big 3 exercises as described by McGill. These include the curl-up, side bridge, and quadruped position on stable gym Floor"
15767191|NCT04718389|Biological|GSK3511294 (Depemokimab)|GSK3511294 (Depemokimab) will be provided in a single-use prefilled syringe (PFS).
15767048|NCT04719663|Behavioral|Biological illness and treatment rationale|Depression is described as a brain disorder and the role of monoamine, brain structures, and brain functions are reported as central mechanisms of relevance for its etiology and treatment. Biological processes are illustrated using typical charts and visualizations. Psychological influences are mentioned, but only as a byproduct of the disorder.
15767049|NCT04719663|Behavioral|Psychological illness and treatment rationale|Depression is described as a psychological disorder resulting from emotion regulation deficits. The suppression of emotions receives a special role in explaining depression. The psychological processes are illustrated using charts and visualizations. Biological aspects are mentioned, but only as a byproduct of the disorder.
15767050|NCT04719663|Drug|Active pharmacological placebo|"The active placebo pill does not have direct effects on the brain. Buscopan (butylscopolamine, 10 mg daily, 1 pill in the morning) does not cross the blood-brain barrier, yet induces some smaller side effects that resemble those of antidepressants (e.g., mouth dryness, fatigue, nausea). Treatment duration is 4 weeks. The rationale is briefly explained to participants as stimulating the biological balance in humans with depression, using a well-tolerated drug similar to Buscopan, which is well-known from pain treatments."
15767051|NCT04719663|Behavioral|Active psychological placebo|"Emotional writing consists of writing about emotional experiences (4 sessions, one per week, 30 minutes each). The study instructor will be present displaying standard psychotherapeutic attitudes but will not read the participant's notes. The rationale for this treatment is briefly explained as improving the dealing with emotions to achieve a psychological balance in humans with depression."
15767052|NCT04719650|Drug|Zoledronic Acid Injection|Infusion 1mg zoledronic acid once.
15767053|NCT04719650|Drug|Zoledronic Acid Injection|Infusion 2.5mg zoledronic acid once.
15767054|NCT04719650|Drug|Zoledronic Acid Injection|Infusion 5mg zoledronic acid once.
15767055|NCT04719650|Drug|Placebo|Infusion normal saline once.
15767056|NCT04719637|Device|PRDS-001 Renal Denervation Ultrasound System|Renal Denervation Ultrasound System
15767057|NCT04719624|Device|Adaptos®-Si [0.5-1 mm] (bone grafting surgery)|After screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of one of the four randomized, synthetic bone graft substitutes with a gelatin sponge (Spongostan Dental). Following 5 months of healing a dental implant will be placed. The subjects will then be followed for another 5 months for healing. Follow-up visits will be at 2 weeks, 5 months, and 10 months.
15767058|NCT04719624|Device|Adaptos®-Si [1-2 mm] (bone grafting surgery)|After screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of one of the four randomized, synthetic bone graft substitutes with a gelatin sponge (Spongostan Dental). Following 5 months of healing a dental implant will be placed. The subjects will then be followed for another 5 months for healing. Follow-up visits will be at 2 weeks, 5 months, and 10 months.
15767059|NCT04719624|Device|Geistlich Bio-Oss (bone grafting surgery)|After screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of one of the four randomized, synthetic bone graft substitutes with a gelatin sponge (Spongostan Dental). Following 5 months of healing a dental implant will be placed. The subjects will then be followed for another 5 months for healing. Follow-up visits will be at 2 weeks, 5 months, and 10 months.
15767060|NCT04719624|Procedure|Tooth extraction without bone graft material|After screening and enrollment, subjects will undergo tooth extraction of a single tooth and the socket is filled only by clot. Subject will be followed at 2 weeks, 5 months, and 10 months for healing.
15767061|NCT04719624|Device|Adaptos® (bone grafting surgery)|After screening and enrollment, subjects will undergo tooth extraction of a single tooth with placement of one of the four randomized, synthetic bone graft substitutes with a gelatin sponge (Spongostan Dental). Following 5 months of healing a dental implant will be placed. The subjects will then be followed for another 5 months for healing. Follow-up visits will be at 2 weeks, 5 months, and 10 months.
15767062|NCT04719611|Dietary Supplement|Probiotic|Healthy women receive a probiotic supplement containing 6 x 10^9 colony-forming units/capsule of Bifidobacterium and Lactobacillus strains.
15767063|NCT04719598|Behavioral|congnitive behavioural therapy|CBT Sessions divide into three main components; 1) cognitive interventions, concerns with cognitive restructuring attempts to change maladaptive thought about thoughts about sleep into more adaptable . 2) Behavioral intervention: concerns with Relaxation training, stimulus control, and sleep restriction promote relaxation and help to establish healthy sleep habits. 3) Psychoeducational interventions: Providing information about the connection between thoughts, feelings, behaviors, and sleep.
15767064|NCT04719585|Drug|Duloxetine vs. Opioid|Prior to discharge, the drug is prescribed for a total of 6 weeks by dividing the duloxetine-administered group and the opioid-administering group, respectively. The administration period of duloxetine or opioid is 6 weeks. The follow-up periods for out-patient clinic are 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after the TKA surgery. During the follow-up period, NSAIDs will be prescribed the same in both groups. As an additional rescue medication, 650 mg of acetaminophen will be allowed to use up to 2g per day.
15767065|NCT04719572|Other|Basic treatment group|A total of 60 subjects were recruited in the group.
15767066|NCT04719572|Other|Basic treatment+ anti-osteoporosis drug group|A total of 60 subjects were recruited in the group.
15767067|NCT04719572|Other|Basic treatment + non-drug treatment group|A total of 60 subjects were recruited in the group.
15767068|NCT04719559|Device|Laser-assisted drug delivery|All patients received treatment using the same protocol with the same fractional ablative carbon dioxide laser (eCO2 PlusTM, manufactured by Lutronic, South Korea). Each patient was applied with Lidopin 5% cream (Panion & BF Biotech Inc.), which remained on the scar for 30 min for pain relief before each laser course. Later, the Lidopin 5% cream was gently removed using a normal saline-rinsed gauze, and the scar was treated with a fractional ablative carbon dioxide laser with two passes under a 10,600 nm wavelength, 120 mm spot size, pulse energy of 50 mJ, 30 W of power, and a density of 200. A topical steroid cream (clobetasol propionate, 0.05%) was evenly applied on the scar gently back and forth using a cotton swab immediately after the laser treatment. The patients underwent five full courses by the same doctor according to the same protocol, with each course given 4 weeks apart.
15767069|NCT04719546|Other|Observation of related perinatal factors|Data described in Primary outcome measures will be collected in both groups
15767071|NCT04719520|Behavioral|wireless vibrating caller|using the wireless vibrating caller to notify the patient's family to the operating room
15767072|NCT04719507|Procedure|erector spinae block|ultrasound probe is placed parallel to the vertebral spine at T4 level and shifted 3 cm laterally to obtain the appropriate visualization. Under aseptic precautions, the needle is inserted and advanced perpendicular to the skin in all planes to contact the transverse process of the vertebra at a variable depth of 2-4 cm from the skin depending on the build of the individual. At this point, the needle tip lies between the erector spinae muscle and transverse process. After negative aspiration, 20 ml of 0.25% bupivacaine is administered in cephalad and caudal directions.
15767073|NCT04719507|Procedure|thoracic paravertebral block|ultrasound probe is placed parallel to the vertebral spine at T4 level and shifted 2-3 cm laterally to obtain the appropriate visualization. Following the identification of pleura, transverse process and paravertebral space, the needle is inserted cranial to caudal direction using in-plane approach . After confirming the displacement of pleura with 0.5-1 ml of local anesthetic (LA), 20 ml of 0.25% bupivacaine is administered for the block.
15767074|NCT04719507|Drug|Pethidine Only Product in Parenteral Dose Form|pethidine (1 mg/kg ) once
15767075|NCT04719494|Other|Dynamic balance walking training|Participants in the training group will walk on an elevated treadmill that will move side-to-side in a pseudorandom manner, thereby increasing the difficulty to their balance. Participants are asked to walk independently for 30-minutes per session, for 12 days over 4 weeks.
15767076|NCT04719481|Drug|Pravastatin Sodium 80 MG|daily oral administration of 80mg
15767077|NCT04719481|Drug|Placebo|daily oral administration
15767078|NCT04719468|Other|Dance with ballet elements|Ballet-based dance sessions will be delivered by trained artists within the English National Ballet group in a professional dance space/ delivered remotely, COVID-19 permitting.
15767079|NCT04719455|Behavioral|Adherence Improving self-Management Strategy|An in-person delivered intervention imbedded in regular follow-up care during 9-months. Patients will receive an electronic monitoring System to track medication intake and a pedometer to count daily amount of steps. During the baseline visit, the health care professional (HCP) will use pre-tested materials for informing and motivating patients; and collaboratively set goals and plans for medication adherence and physical activity. During regular follow-up consultations with the HCP, personalized visual reports of medication intake and amount of steps will be evaluated to enhance patients awareness of their (non-)adherence and (in)activity and identify any problems and solutions to reduce undesired behaviour. The control group will receive usual treatment only.
15767080|NCT04719455|Other|Regular care|Treatment as usual (appointments with nurse/nurse practioner with regular content)
15767081|NCT04719442|Behavioral|Building Healthy Families|Building Healthy Families (BHF) is a family based obesity treatment program which includes key behavior change strategies including goal setting for both behavior change and weight loss, self-monitoring, rewards/contingency management, role modeling, and stimulus control/ modifying the environment. BHF includes a minimum of 32 contact hours consisting of three main program components: nutrition education, behavior modification, and physical activity. Participants and parents are expected to attend 12 continuous weeks of education (2 hours/session) followed by 12 weeks of relapse prevention refresher courses. Relapse prevention refresher sessions are every three weeks for one hour to re-evaluate goals, discuss rewards/contingency management and changes in stimulus control with seasonal changes and holidays. A final follow-up check-in session is conducted at 12 months for approximately 1 hour.
15767082|NCT04719429|Dietary Supplement|Cricket-derived Protein|Beverage containing 25 g cricket-derived protein
15767083|NCT04719429|Dietary Supplement|Beef-derived Protein|Beverage containing 25 g beef-derived protein
15767084|NCT04719416|Behavioral|Guided Meditation|Approximately 10 minute recording of guided meditation focuses on muscle relaxation.
15767085|NCT04719403|Other|HealthPAL|Participants who are randomly assigned to the HealthPAL arm will have immediate post- visit access to audio/video-recordings of their clinical visit through a HIPAA-compliant web-based program called HealthPAL.
15767086|NCT04719390|Behavioral|TMI Component|The text messaging intervention will include 2 motivational interviewing components and 2 cognitive behavioral therapy components, targeting motivation and coping, and taking a harm reduction approach.
15767087|NCT04719377|Device|catheter placement|catheter placement
15767088|NCT04719351|Behavioral|The DIARY mobile application|The mobile application has two main functionalities. First, it will remind the user to report in regular time periods on their mental health status (e.g., sleep disturbances, stress). The assessment is done daily for four weeks. Second, some completed assessments will be combined with a behavioral prompt i.e. short message encouraging the user to engage in one of the strategies that can help coping with stress at work, e.g. remember to take short breaks, exercise in daylight, summarize a day with a colleague after a finished shift.
15767089|NCT04719338|Diagnostic Test|presence of HCV RNA in peripheral blood mononuclear cells (PBMCs) .|samples of peripheral blood from each patient into EDTA tube will be collected and tested for HCV RNA in peripheral blood mononuclear cells (PBMCs) .
15767090|NCT04719325|Other|Herbert screw|Fracture line exposed through intra-oral approach. bone reduction into proper anatomical occlusion and application of Herbert screw
15767091|NCT04719325|Other|Lag screw|Fracture line exposed through intra-oral approach. bone reduction into proper anatomical occlusion. Application of either lag screw according to Champy's osteosynthesis lines.
15767092|NCT04719312|Procedure|Y modification of transconjunctival approach|"Section of the orbital septum is done at the Arcus Marginalis and subperiosteal dissection done to expose the infraorbital rim and orbital floor.
~Subsequently, canthotomy of the superficial limb of the lateral canthal ligament is performed and subperiosteal dissection is carried out to expose the fracture at the frontozygomatic region.
~The cutaneous Y will transform into a box when retracting its corners, increasing the working area and allowing access of the frontozygomatic (FZ) suture, lateral orbital wall, body of the zygoma, infraorbital rim, and floor of the orbit with a single approach.
~A small upper vestibular incision is placed to expose the fracture at the zygomatic buttress. Reduction and fixation of fractures in a regular fashion are accomplished."
15767093|NCT04719299|Behavioral|Tell-Play-Do|Using smart phone application
15767094|NCT04719299|Behavioral|Tell-Show-Do|Using traditional behavior management technique
15767123|NCT04719065|Drug|Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)|Subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/ m2, IV, on day 1 of each cycle for a maximum of 8 cycles.
15767095|NCT04719286|Device|MinSafeStart app|The intervention is the opportunity of using the MinSafeStart app. Women can register their NVP severity in the app by answering a few questions daily. Based on this, they will get tailored advice on NVP, and get alert when they should see a doctor.
15767096|NCT04719273|Drug|Extended-release Onapristone|Given PO
15767097|NCT04719273|Drug|Anastrozole|Given PO
15767098|NCT04719273|Other|Quality-of-Life Assessment|Ancillary studies
15767099|NCT04719273|Other|Questionnaire Administration|Ancillary studies
15767100|NCT04719260|Behavioral|Nutrition Thinking®|In the first session, the nutritionist will carry out the anamnesis through the Empathy Map and assessment of the nutritional status to define the Nutrition Briefing. The steps described by Design Thinking as understanding, observation, and point of view comprise the first phase of this session. The ideation process will proceed from the definition of the Nutrition Challenge. Prototyping is the final stage of the first session, where an initial prototype of the diet will be co-created based on visual thinking tools and the description underlying the creation of diets. Within 24 hours the individual will receive a summary of the material developed by email. The period between sessions will comprise the testing phase and the follow-up sessions the iteration phase where the experience and previous steps are revisited in order to create new insights, anthropometric measurements will be seen as reflections of the experience and not as primary outcomes of the intervention.
15767101|NCT04719260|Behavioral|Standard Nutritional Approach|In the first session the nutritionist will carry out the food and nutritional anamnesis and assessment of the nutritional status. From this information, the nutritionist will generate the diagnostic hypothesis and determine the specific nutritional needs. The professional will be responsible for generating the dietary prescription defining the characteristics of the diet that will be delivered printed to the individual after a period of 15 days, in the second session of the protocol. The follow-up session will be based on adherence to the established conduct and monitoring of anthropometric variations.
15767102|NCT04719247|Procedure|Pulpotomy|Irreversibly damaged dental pulp is partially removed and a dressing either Turmeric or Thymus Vulgaris or Nigella Sativa or Aloe Vera is placed. Clinical and Radiographic signs and symptoms are assessed and compared with Formocresol.
15767103|NCT04719234|Device|lung ultrasonography|Application of 12 zone lung ultrasonography protocol using the konvex ultrasound probe (2-6 MHz)
15767104|NCT04719221|Drug|Evolocumab|The maximum dose of combined cholesterol therapy (Statin + Ezetimibe) is prescribed for 2 months, and a cholesterol test is performed in an outpatient clinic to ensure that LDL-Cholesterol <70mg/dL is met. Patients who do not meet the criteria are randomized to maintain current treatment or receive additional Evolocumab according to randomization.
15767105|NCT04719221|Device|NIRS IVUS|near-infrared spectroscopy
15767106|NCT04719208|Other|Water (E) Mouth rinse with the solution provided|Subject will be asked to perform a simple mouth rinse for 2 minutes with one of the 5 mouth washes to be tested.
15767107|NCT04719208|Other|Chlorhexidine gluconate (A) Mouth rinse with the solution provided|Subject will be asked to perform a simple mouth rinse for 2 minutes with one of the 5 mouth washes to be tested.
15767108|NCT04719208|Other|Hydrogen peroxide (B) Mouth rinse with the solution provided|Subject will be asked to perform a simple mouth rinse for 2 minutes with one of the 5 mouth washes to be tested.
15767109|NCT04719208|Other|Betadine (C) Mouth rinse with the solution provided|Subject will be asked to perform a simple mouth rinse for 2 minutes with one of the 5 mouth washes to be tested.
15767110|NCT04719208|Other|Alcohol mouthwash (Listerine) (D) Mouth rinse with the solution provided|Subject will be asked to perform a simple mouth rinse for 2 minutes with one of the 5 mouth washes to be tested.
15767111|NCT04719195|Other|Meniscus extrusion ultrasonogrphic evaluation|This study will enroll the patients with knee medial compartment osteoarthritis of the knee joint who undergo open proximal tibial osteotomy. The degree of medial and lateral meniscus extrusion will be measured through ultrasound measurements before and after surgery. Also, demographic factors and radiographic measurements will be also investigated before and after surgery. In addition, preoperative, postoperative 3, 6, and 1 year clinical results including meniscus extrusion will be compared and judged, and the evaluation will be evaluated by an orthopedic surgeon who has not participated in the operation among registered researchers.
15767112|NCT04719182|Other|Adjunctive therapies|Determine and compare practice of adjunctive and supportive treatments for COVID-19
15767113|NCT04719169|Diagnostic Test|Dynamic MRI enema|Dynamic MRI enema
15767114|NCT04719169|Diagnostic Test|Fluoroscopic enema|Fluoroscopic enema
15767115|NCT04719156|Drug|Indocyanine green solution administered at 2.5mg/kg.|Dosing of ICG to be administered at 2.5mg/kg, two hours prior to surgery.
15767116|NCT04719156|Device|Stryker SPY-PHI Imaging Device|The SPY-PHI system is used with the ICG dye to provide fluorescence images.
15767117|NCT04719143|Behavioral|Cognitive Behavioral Therapy for Insomnia (CBT-I)|Subjects receive 6-8 CBT-I sessions in an individual format.
15767118|NCT04719130|Other|Multimodal circuit exercise|A structured and supervised multimodal exercise circuit twice a week, under 12 weeks program. The circuit workout program consists of 8 exercises, divided into motor coordination, balance, strength, and aerobic exercises. The exercises will be employed in a reserved room inside of the Basic Health Units. The sessions of exercises will last approximately 50 minutes,
15767119|NCT04719130|Other|Multidisciplinary lectures|Multidisciplinary lectures on pain and usual care provided by the Basic Health Units. A cycle of multidisciplinary lectures on pain will be offered by professionals in physical education, nursing, physiotherapy, medicine, psychology and social work that will take place in the Basic Health Units every 15 days.
15767120|NCT04719104|Device|Transcutaneous Bilirubin Meter - 'Bilimeter'|Taking a transcutaneous (TcB) measurement will involve using a 'biliflash'. This is a non-invasive measurement that involves flashing a light against the helix of the infant's ear and can be done at the cotside. This process takes approximately 1-2 minutes and does not cause the baby discomfort. The meter gives an immediate bilirubin level.
15767121|NCT04719091|Device|Lubricity|Oral spray
15767122|NCT04719078|Diagnostic Test|MRI of the chest|The study participants will obtain a MRI of the thorax with one of the institutions MR machines (Philips Achieva 1.5T, GE Discovery 3T, MRI Siemens Skyra 3T, and GE SIGNA Artist 1.5T). The study participant will be asked to lie in the MR scanner for about 30 minutes while the images will be acquired. The image acquisition with the above-mentioned MR machines is authorised in Switzerland and the application is done according to the product information.
15767124|NCT04719052|Other|Diet and behavioural intervention|Intervention will receive a specific diet designed following the characteristics of Mediterranean Diet
15767125|NCT04719052|Other|Diet and behavioural intervention|Control group will receive a specific diet designed following the characteristics of Low fat Diet.
15767126|NCT04719039|Behavioral|Restorative Yoga Internvention|Participants in the intervention group will receive links to two 60-min videos per week for 8 consecutive weeks. Each video will include a yoga practice guided by a certified yoga instructor. The intervention group is required to perform the yoga practice at least two times per week. If preferred, they can do additional sessions with the videos and record their total hours of self-practice.
15767127|NCT04719026|Other|Full-mouth periodontal examination using computerised Florida probe|It is an observational study to investigate the prevalence of periodontitis in cases and controls.
15767128|NCT04719013|Device|Evoke radiofrequency device|Enrolled subjects will undergo up to 3 successive bi-weekly (every 2 weeks) treatments,
15767129|NCT04719000|Drug|rhFSH+rhLH|300 IU of rhFSH and 150 IU of rhLH (Pergoveris®) GnRH antagonist: cetrorelix 0.25 mg (Cetrotide® - Merck) GnRH antagonist: cetrorelix 0.25 mg (Cetrotide® - Merck) Recombinant human chorionic gonadotropin (rhCG) 6500 IU (Ovitrelle® - Merck) micronized progesterone 90 mg (Crinone 8% ® - Merck)
15767130|NCT04719000|Drug|rhFSH|300 IU rhFSH (Gonal-F®- Merck) GnRH antagonist: cetrorelix 0.25 mg (Cetrotide® - Merck) GnRH antagonist: cetrorelix 0.25 mg (Cetrotide® - Merck) rhCG 6500 IU (Ovitrelle® - Merck) micronized progesterone 90 mg (Crinone 8% ® - Merck)
15767131|NCT04718987|Radiation|Low dose rate (LDR) brachytherapy|Low dose rate (LDR) brachytherapy is a type of radiation treatment where doctor places the radioactive implants (seeds) inside patient's prostate gland and these seeds emits low dose radiation over a certain period of time. During low-dose-rate brachytherapy, a continuous low dose of radiation is released over time -from several hours to several days.
15767132|NCT04718974|Other|mHealth call for life system/ tool using IVR ( interactive voice response)|The tool capitalises on a basic mobile phone's core utilities of voice and short messaging services. The system design, development, testing and evaluation was done by Janssen and the Grameen Foundation (http://motechsuite.org/index.php/implementations). In 2015, Janssen Global Public Health Research and Development, in close collaboration with the Infectious Diseases Institute Kampala (IDI), developed Call for Life Uganda (CFLU) tailored to the needs of PLHIV in Uganda
15767133|NCT04718961|Drug|Volixibat|Oral capsules, administered twice daily. Volixibat is an apical sodium-dependent bile acid transporter (ASBT) inhibitor.
15767134|NCT04718961|Drug|Placebo|Capsules matched to study drug minus active substance.
15767135|NCT04718948|Device|Urinary Multimodal Fiber Optic Spectroscopy|"Approach based on a physical principle, mainly spectroscopy, which is rapid non-invasive and does not require the use of additional substances or contrast media in the diagnosis of urothelial neoplasms in urine samples.
~It will be administered through a appositely designed device"
15767136|NCT04718948|Diagnostic Test|Urine Cytology|An expert cytopathologist will analyze urine samples to detect urinary tract cancer cells. It is the current golden standard to detect urothelial cancer in urine
15767137|NCT04718948|Procedure|Surgery|It will provide a reliable information on the presence/absence of cancer in the urinary tract (from direct visualization to pathological analysis)
15767138|NCT04718922|Drug|Chlorhexidine Gluconate 0.12 % Mouthwash|Intervention with chlorhexidine mouthrinse will be performed approximately 10 min before the start of EBUS-TBNA
15767139|NCT04718909|Drug|Regorafenib + sintilimab|"Regorafenib: 160 mg p.o. qd for 3 weeks of every 4 week cycle (i.e. 3 weeks on, 1 week off).
~Sintilimab: 200mg i.v. q3w."
15767140|NCT04718909|Drug|Regorafenib|160 mg p.o. qd for 3 weeks of every 4 week cycle.
15767142|NCT04718883|Biological|CD19-targeted Chimeric Antigen Receptor (CAR) T Cells|JWCAR029 will be administered at dose level: 1 x 10^8 CAR+T cells
15767143|NCT04718870|Drug|Dupilumab SAR231893|Pharmaceutical form: solution for injection Route of administration: subcutaneous (SC)
15767144|NCT04718857|Behavioral|Online education|health education
15767145|NCT04718844|Drug|SLN124|SLN124 for subcutaneous (s.c.) injection
15767146|NCT04718844|Drug|Placebo|Sodium chloride for s.c. injection
15767147|NCT04718831|Dietary Supplement|Spirulina|Spirulina, as demonstrated in previous researches in vitro and in animals, can regulate immunity, enhance anti-virus activity, lower inflammation response and slower tumor progression. Liver function and liver fibrosis is improved by Spirulina as well. In our recent clinical trial, hepatitis B patients that received anti-virus medicine orally and was supplemented with Spirulina FEM-102 showed lower qHBsAg, reflecting the clearance of cccDNA. It might be related to immune modulation against HBV, which is induced by Spirulina.
15767148|NCT04718805|Drug|Darunavir|Participants will receive a single dose of Darunavir tablets orally as per assigned treatment sequence.
15767149|NCT04718805|Drug|Cobicistat|Participant will receive a single dose of Cobicistat tablets orally as per assigned treatment sequence.
15767150|NCT04718805|Drug|Darunavir/Cobicistat FDC|Participants will receive a single dose of darunavir and cobicistat FDC tablets orally as per assigned treatment sequence.
15767151|NCT04718792|Drug|Psilocybin|A single administration psilocybin (25mg, opaque capsule for oral ingestion). The psilocybin is synthetically manufactured under current Good Manufacturing Practices (cGMP)
15767152|NCT04718779|Drug|Velaglucerase alfa|Participants will receive VPRIV 60 U/kg intravenous infusion every other week for 60 minutes.
15767153|NCT04718753|Behavioral|Mindful breathing intervention|Mindful breathing intervention audio, which is used in mindfulness-based interventions, will be sent to the participants once per day.
15767154|NCT04718740|Drug|fluzoparib|Group A: Caffeine, vitamin K, warfarin, omeprazole, and midazolam with or without fluzoparib Group B: Repaglinide and bupropion with or without fluzoparib
15767155|NCT04718727|Drug|Placebo|oral Placebo tablets one-hour preoperatively
15767156|NCT04718727|Drug|5 mg Olanzapine Tablets|oral 5 mg Olanzapine tablets one-hour preoperatively
15767157|NCT04718727|Drug|10 mg Olanzapine Tablets|oral 10 mg Olanzapine tablets one-hour preoperatively
15767158|NCT04718714|Drug|Midazolam|loading dose intravenous infusion of 0.2 mg/kg over 10 minutes followed by a maintenance dose of 0.02 -0.2 mg /kg/hr. over 24 hours.
15767192|NCT04718389|Biological|Mepolizumab|Mepolizumab will be provided in a single-use PFS.
15767159|NCT04718714|Drug|Propofol|loading dose intravenous infusion of one mg/kg over 15 minutes followed by a maintenance dose of 20-80 microgram/kg/min. over 24 hours.
15767160|NCT04718714|Drug|Dexmedetomidine|loading dose of dexmedetomidine of one µg/kg over 10 minutes followed by maintenance dose of 0.2 -1.5 µg/kg/hr. over 24 hours.
15767161|NCT04718701|Drug|Anlotinib+Toripalimab+Nab-paclitaxel|Using combination treatment of anlotinib (12 mg, po. qd.) plus toripalimab (240 mg, ivgtt. q3w.) and nab-paclitaxel (260 mg/m2, ivgtt, q3w) with every 3 weeks as a cycle.
15767162|NCT04718688|Other|CO-OP rehabilitation|"The intervention was included within the child's conventional rehabilitation program.
~In the CO-OP original protocol, the child sets 3 goals. Here, we concentrated on two rather than three goals, as addressing three occupations per session seemed too ambitious given the children's cognitive profile (the third goal served as control goal).
~We chose to increase the number of sessions to 14 (two sessions per week for seven weeks, vs ten in the original protocol).
~The global strategy was taught to the child at the first session. The following sessions consisted of an iterative process of implementation of the global strategy in the context of guided discovery to identify domain specific strategies to overcome performance ''breakdowns the children were experiencing when performing the self-selected tasks. In addition, homework was assigned to encourage the application and practice. Parents were invited to attend the sessions if it was possible for them."
15767163|NCT04718675|Drug|KB-0742|Oral capsules
15767164|NCT04718662|Dietary Supplement|2'-fucosyllactose|Oligosaccharide added to infant's breast milk diet (or placebo)
15767165|NCT04718662|Dietary Supplement|Placebo|Oral dextrose
15767166|NCT04718649|Drug|Celebrex with Joins or not|The enrolled patienst will be divided into the group taking celecoxib 200mg with Joins tab together and the group taking celecoxib 200mg with Joins placebo in the same probability of 2:1 according to the randomization table at the first outpatient visit. Among the co-researchers, one researcher who is in charge of patient assignment will create a randomization table through computer generated randomization. And this researcher who is charge of the patient assignment will not intervene in any other process of this study, and only participates in the task of selecting the assigned group using random checks. The evaluation will be evaluated by an researcher who is not aware of the patient allocation according to the randomization table among researchers participating in the clinical study
15767169|NCT04718623|Diagnostic Test|Quantitative determination of serum Presepsin (sCD-14), and Syndecan-1 concentrations|Quantitative determination of serum Presepsin (sCD-14), and Syndecan-1 concentrations by ELISA technique
15767170|NCT04718610|Other|Osteopathic intervention|Nerve vagus stimulation
15767171|NCT04718610|Biological|CRP assessment|Blood CRP will be assessed during trial
15767172|NCT04718610|Behavioral|QLQ-C30 questionnaire|Completion of QLQ-C30
15767173|NCT04718597|Procedure|Robotic assisted inguinal hernia repair|Robotic assisted inguinal hernia repair with DaVinci Xi system instead of open repair
15767174|NCT04718597|Procedure|Open inguinal hernia repair|Classical approach (open repair)
15767175|NCT04718584|Drug|Human Anti-PD-L1 Monoclonal Antibody Injection (LDP)|All participants will receive treatment with LDP 10mg/kg once every two weeks, every 2 weeks will be a cycle. In Cort 1, surgical treatment will be performed within 2 weeks after the end of 3 cycles of treatment.
15767176|NCT04718545|Procedure|Mucogingival surgery|The gingival recession at mandibular incisor site will be covered by a gingival graft harvested from the palate.
15767177|NCT04718506|Behavioral|Exercise|Participants from the experimental group will complete 8 weeks of a tailored, educational and supervised multicomponent exercise program adapted from the ACSM guidelines for Chronic Obstructive Pulmonary Disease and Cardiovascular Disease. Concurrent training (i.e., develop both aerobic capacity and strength within the same training session) will be adopted since its greater adherence and proven adaptations in 6 weeks. Participants will complete a 3-days-a-week training routine: two days of resistance training (RT, 50-75% 1RM (one-repetition maximum), 2-4 sets, 6-12 repetitions, 5 exercises) combined with Moderate Intensity Variable Training (MIVT: 4-6 x 3-5 min at 65-80% Heart Rate Reserve (HRR) / 2-3 min at 50-70% HRR), and one day of Light Intensity Continuous Training (LICT: 30-60 min, 65-70% HRR). Progressions will be individualized and consistent with patient tolerance. Sessions will be supervised by certified strength and conditioning coaches, Graduated in Sports Sciences
15767178|NCT04718506|Behavioral|Controls|Controls will follow the general physical activity and return to sport guidelines provided by the SEPAR
15767179|NCT04718493|Procedure|Self-expandable metal stent|Endoscopic stenting of intestinal stricture related to Crohn´s disease
15767180|NCT04718493|Procedure|Balloon dilatation|Endoscopic balloon dilatation of intestinal stricture related to Crohn´s disease
15767181|NCT04718480|Drug|Placebo|po placebo tablets
15767182|NCT04718480|Drug|Fluvoxamine|po fluvoxamine tablets
15767183|NCT04718467|Biological|Recombinant COVID-19 vaccine (Sf9 cells)|Three doses of Recombinant COVID-19 vaccine (Sf9 cells) (40μg) at the schedule of day 0, 21, 42.
15767184|NCT04718467|Biological|Placebo|Three doses of Placebo (1.0ml) at the schedule of day 0, 21, 42.
15767185|NCT04718454|Device|dental attachment|This research aimed to evaluate the retentive power and wear of the smart box attachment use with tilted two implant assisted mandibular overdenture
15767186|NCT04718441|Drug|Lumason|Lumason will be administered at a dose of 0.03 mL/kg up to a maximum dose of 2.4mL injected into a peripheral intravenous catheter. An abdominal contrast enhanced ultrasound will be performed to look for solid organ injury. The will be given twice during the intervention, for a total maximum dose per subject of 4.8mL.
15767187|NCT04718428|Diagnostic Test|Nail Ultrasonography|The MyLab 60 (Esaote Biomedica Genoa, Italy) device and linear probe were used. Nails were examined in B-mode grayscale and power Doppler.
15767188|NCT04718415|Drug|sintilimab, paclitaxel, carboplatin|Patients receive sintilimab IV on day 1, paclitaxel IV on day 1 and carboplatin IV on day 1 . Treatment repeats every 21 days for up to 2 - 4 courses in the absence of disease progression or unacceptable toxicity.
15767189|NCT04718415|Procedure|Surgical resection|Surgical therapy will be at the discretion of the treating surgeon per standard of care.
15767190|NCT04718402|Drug|Mitoxantrone Hydrochloride Liposome, intravenous injection|All subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2, IV, on day 1 of each 21-day cycle (q3w).
15767402|NCT04716920|Other|Quality-of-Life Assessment|Ancillary studies
15767193|NCT04718389|Biological|Benralizumab|Benralizumab will be provided in a single-use PFS.
15767194|NCT04718389|Biological|Placebo|Placebo will be a sterile liquid formulation.
15767195|NCT04718389|Drug|Standard of care (SoC)|Non-biologic SoC will include inhaled corticosteroid (ICS) plus at least one other controller, long-acting beta-2-agonist (LABA), long-acting muscarinic antagonist (LAMA), with or without maintenance oral corticosteroids (OCS).
15767196|NCT04718389|Device|Pre-filled Syringes (PFS)|PFS will include glass barrel with pre-staked needle and plunger.
15767197|NCT04718376|Drug|Mitoxantrone Hydrochloride Liposome, intravenous injection (IV)|All subjects will receive Mitoxantrone Hydrochloride Liposome 20 mg/m2, IV, on day 1 of each 21-day cycle (q3w).
15767198|NCT04718363|Other|PNF stretching|A contract-relax PNF stretching technique will be applied to hamstring muscle.
15767199|NCT04718363|Other|Non-vibration foam rolling prior to PNF stretching|Prior to PNF stretching, participant will perform unilateral hamstring non-vibration foam rolling.
15767200|NCT04718363|Other|Vibration foam rolling prior to PNF stretching|Prior to PNF stretching, participant will perform unilateral hamstring vibration foam rolling (48 Hz).
15767201|NCT04718350|Drug|levosimendan at a dose of 6 mcg/kg|levosimendan will be administered intravenously at a dose of 6 mcg/kg after anesthesia induction
15767202|NCT04718350|Drug|milrinone at a dose of 50 mcg/kg|milrinone will be administered via inhalation at a dose of 50 mcg/kg after anesthesia induction
15767203|NCT04718324|Other|e-PROMS|Participants randomised to the e-PROMS arm will receive a safe link to the e-PROMS and a unique identification number in the electronic form, so as to preserve anonymity. This is a one-time intervention
15767204|NCT04718324|Other|p-PROMS|Participants randomised to the p-PROMS arm will receive the PROMS and PREMS questionnaires and a unique identification number in paper form.
15767205|NCT04718311|Drug|Oral lichen clinical Healing evaluation|Treatments were topically applied for 5 days
15767206|NCT04718298|Device|ProFlor laparoscopic technique|Inguinal hernia repair laparoscopic
15767207|NCT04718285|Drug|Montelukast Oral Tablet|6x10 mg oral montelukast daily for 14 days.
15767208|NCT04718285|Drug|Montelukast plus Favicovir (Favipiravir)|200 mg oral favicovir for 5 days in a regimen of 2x1600 mg (oral) loading dose on day-1 (eight tablets in the morning and eight tablets in the evening) followed by 2x600 mg maintenance dose (three tablets in the morning and three tablets in the evening) on day-2 to day-5 and 6x10 mg oral montelukast daily for 14 days, concurrently.
15767209|NCT04718285|Drug|Favicovir (Standard Treatment)|200 mg oral favicovir for 5 days in a regimen of 2x1600 mg (oral) loading dose on day-1 (eight tablets in the morning and eight tablets in the evening) followed by 2x600 mg maintenance dose (three tablets in the morning and three tablets in the evening) on day-2 to day-5.
15767210|NCT04718272|Procedure|thoracic drainage management|After uniportal VATS pulmonary lobectomy, the traditional silicone tube which placed through the surgical incision was removed in the operating room in the experimental group.
15767211|NCT04718259|Drug|intrathecal bupivacaine|The use of intrathecal bupivacaine will be compared to the use of intrathecal bupivacaine and midazolam.
15767212|NCT04718259|Drug|midazolam|midazolam
15767213|NCT04718246|Other|Dental Implants Placed In hyperlipidemia patients|"A preoperative cone beam CT (CBCT) will be performed for each patient prior to the surgery.
~Surgical phase (T0):
~After local anesthetics, all osteotomies will be prepared by the same operator, using a drilling speed of 1200 rpm, under copious irrigation with normal saline.
~Penetration of cortical bone will be achieved with no. 6 round burs.
~The osteotomies will be widened, using a drill 1 mm larger than the final drill provided by the manufacturer. The final size of the control osteotomies were same diameter of the implant.
~Periotest® will measure initial implant stability. Implant site exposure will take place 6 months following the implant placement. Insertion of the healing collars in order to obtain adequate soft tissue form for 1-2 weeks"
15767214|NCT04718233|Drug|Sildenafil 25Mg Tablet|Sildenafil citrate at a dose of 25mg will be administered orally in patients with recurrent pregnancy loss
15767215|NCT04718233|Drug|Placebo Oral Tablet|placebo will be administered orally in patients with recurrent pregnancy loss
15767216|NCT04718220|Diagnostic Test|Antibody testing for SARS-CoV-2 IgG|Women enrolled into the unexposed (SARS-CoV-2 negative) cohort will undergo testing for SARS-CoV-2 IgG antibodies at enrollment, every trimester of pregnancy, and during delivery hospitalization.
15767217|NCT04718220|Diagnostic Test|Testing for SARS-CoV-2 RNA|Women in the exposed (SARS-CoV-2 positive) cohort will undergo testing of placental tissue, umbilical cord blood, amniotic tissue, and neonates for SARS-CoV-2 RNA, as available.
15767218|NCT04718220|Diagnostic Test|Testing for SARS-CoV-2 IgM/IgG|Women in the exposed (SARS-CoV-2 positive) cohort will undergo testing of umbilical cord blood for SARS-CoV-2 IgG and IgM antibodies, as available.
15767219|NCT04718207|Device|Brain positron emission tomopgraphy (PET) - scan|Patients who performed brain PET/CT scans in the nuclear medicine department from December 2017 to December 2020.
15767220|NCT04718194|Behavioral|ESTEEM iCBT|The online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
15767221|NCT04718194|Behavioral|Self-monitoring control|Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
15767222|NCT04718181|Drug|risdiplam|Risdiplam will be administered orally at a single dose of 5 mg in different formulations. Dispersible tablet formulations (F21/F22) will be administered as swallowed tablet or as tablet dispersed in water. The powder for constitution to an oral solution will be administered as an oral solution constituted with purified water.
15767223|NCT04718181|Drug|omeprazole|Omeprazole will be administered orally as a capsule at a dose of 40 mg per day
15767224|NCT04718168|Device|Gore ENFORM Biomaterial (Preperitoneal)|ENFORM Biomaterial bioabsorbable hernia mesh
15767225|NCT04718168|Device|Gore ENFORM Biomaterial (Intraperitoneal)|ENFORM Biomaterial bioabsorbable hernia mesh
15767226|NCT04718155|Drug|Atorvastatin|will receive 40 mg atrorvastatin 2 days
15767227|NCT04718155|Other|placebo|will receive 40 mg placebo 2 days
15767228|NCT04718142|Device|vNEP|Apply vNEP therapy to the anterior surface of the throat with a variable negative pressure ranging from -20 cmH2O up to -35 cmH2O and vNEP devices of varying shapes and sizes.
15767403|NCT04716907|Genetic|Single-Nucleotide Polymorphisms (SNP) within the TCRA/D region|DNA extraction from blood samples, PCR and Sequencing
15767229|NCT04718129|Behavioral|Youth Mindful Awareness Program (YMAP)|The Mindfulness Intervention is an app-based program that involves a coach. It is 9 weekly sessions and involves practicing the skills between sessions.
15767230|NCT04718116|Drug|Group tapentadol 50 mg|patients in group A will receive tapentadol 50 mg p.o 3 times daily for two days
15767231|NCT04718116|Drug|group tapentadol 75 mg|patients in group B will receive tapentadol 75 mg p.o 3 times daily for two days
15767232|NCT04718116|Drug|group tramadol 100 mg|patients in group C will receive tramadol 100 mg p.o 3 times daily for two days
15767233|NCT04718103|Biological|GSK3511294 (Depemokimab)|GSK3511294 (Depemokimab) will be provided in a single-use prefilled syringe.
15767234|NCT04718103|Biological|Placebo|Placebo will be available as normal saline in a single-use prefilled syringe.
15767235|NCT04718103|Drug|Standard of Care|SoC will include ICS plus at least one other controller, Long acting beta-2-agonist (LABA), Long-acting muscarinic antagonist (LAMA), with or without maintenance oral corticosteroids (OCS).
15767236|NCT04718103|Device|Pre-filled Syringe|Pre-filled syringe will include glass barrel with pre-staked needle and plunger.
15767237|NCT04718090|Procedure|PENG Block|Pericapsular nerve group block in shoulder surgery.
15767238|NCT04718077|Other|Intraosseus|IO dexamethasone injection Dexamethasone 4 mg
15767239|NCT04718077|Other|Submucoal|SM dexamethasone injection Dexamethasone 4 mg
15767240|NCT04718064|Drug|Fingolimod|fingolimod (Gilenya, Novartis) at a dosage of 0.5 mg once daily, for three consecutive days
15767241|NCT04718064|Drug|placebo|placebo once daily, for three consecutive days,
15767242|NCT04718051|Drug|Shen Pu Yang Gan Wan|Shen Pu Yang Gan Wan is Traditional Chinese Medicine; in addition, it has a high dose.
15767243|NCT04718051|Drug|Placebo|Shen Pu Yang Gan Wan is Traditional Chinese Medicine; however, it has a very low dose.
15767244|NCT04718038|Drug|Cetuximab combind mFOLFOX6/FOLFIRI|Cetuximab 500mg/m2 ivgtt 2h d1 ,q14d;mFOLFOX6: Oxaliplatin 85mg/m2 ivgtt 2h d1, 5-Fu 400mg/m2 iv d1,Lefucovorin 400mg/m2 ivgtt 2h d1, 5-Fu 2.4/m2 CIV 46h, q14d; FOLFIRI: CPT-11 180mg/m2 ivgtt 60-90mins d1, 5-Fu 400mg/m2 iv d1,Lefucovorin 400mg/m2 ivgtt 2h d1,5-Fu 2.4/m2 CIV 46-48h, q14d
15767245|NCT04718025|Drug|Ticagrelor 90mg|Up to day 30 after ACS, all enrolled patients will receive standard-dose ticagrelor 2x90mg as a part of dual antiplatelet therapy. Participants in SDTA arm will continue treatment with ticagrelor 2x90mg until 12 months post-ACS, while patients in LDTA and LDTP will be switched to low-dose ticagrelor 2x60 mg starting on day 31.
15767246|NCT04718025|Drug|Ticagrelor 60mg|Starting from day 31, LDTA and LDTP patients will receive low-dose ticagrelor 2x60mg until 12 months post-ACS.
15767247|NCT04718025|Drug|Aspirin|Up to day 90 after ACS, all enrolled patients will receive aspirin 1x100mg as a part of dual antiplatelet therapy. Starting from day 91, LDTP patients will discontinue aspirin and proceed with low-dose ticagrelor monotherapy until 12 months post-ACS, while patients in LDTA and SDTA will continue aspirin 1x100 mg until 12 months post-ACS.
15767248|NCT04717999|Biological|NKG2D CAR-T|The NKG2D CAR-T will be administrated via intracerebroventricular injection through an Ommaya catheter. Standard treatments such as temozolomide will be stopped during the infusion of NKG2D CAR-T.
15767249|NCT04717986|Drug|Dapagliflozin 10Mg Tab|patients who meet the inclusion criteria will be randomized to receive dapagliflozin 10 mg every 24 hours for 12 months
15767250|NCT04717986|Drug|Placebo|patients meeting the inclusion criteria will be randomized to receive a placebo solution every 24 hours for 12 months
15767251|NCT04717973|Diagnostic Test|laboratory testing of CBC, serum ferritin, and vitamin B 12|"laboratory testing of CBC, serum ferritin, and vitamin B 12, vitamin D and ionized serum calcium after the 1st month, 3rd month, 6th month, and then after one year postoperative.
~The pre-operative and post-operative measures will be compared in patients who will be subjected to Laparoscopic Sleeve Gastrectomy versus Laparoscopic Gastric Bypass."
15767252|NCT04717960|Procedure|nasal submucosal injection of platelet rich plasma|"The selected region will be inﬁltrated with a cold saline solution with addition of 1 mL of adrenaline and 25 mL of 2% lignocaine per 500 mL saline.
~Platelet-rich plasma is prepared by drawing 10 mL of blood sample from the patient.
~The blood will be centrifuged at 1530 g for 10 min to obtain platelet-poor plasma.
~This will again centrifuged at 2720 g for 10 min to get platelet-rich plasma.
~Approximately 1 mL of platelet-rich plasma will be obtained from 10 mL blood. Usually amount of about 3ml is needed to be injected in each nostril at the affected sites of inferior and middle turbinates, septum and floor of the nose. Platelet rich plasma injected into the affected area after degranulating the platelet by adding 0.5 mL of calcium chloride.
~Injection interval of 2 weeks (up to total 3 consecutive injections).
~Follow-up duration: 4 months"
15767253|NCT04717947|Procedure|Interval between NAT and surgery|Evaluate three groups according to the interval between the end of neoadjuvant therapy and surgery.
15767254|NCT04717934|Device|GAL1906|hyaluronic acid dermal filler gel
15767255|NCT04717908|Drug|Bedaquiline|400 mg once daily for 2 weeks then 200mg 3 times per week;
15767256|NCT04717908|Drug|Pyrazinamide|1500 mg daily
15767257|NCT04717908|Drug|Linezolid|600 mg daily
15767258|NCT04717908|Drug|Cycloserine|≤50kg 500 mg daily, >50kg 750mg daily;
15767259|NCT04717908|Drug|Clofazimine|100 mg daily;
15767260|NCT04717895|Diagnostic Test|Rocking environment forward (B) followed by a translation environment|Start by the virtual reality session by viewing a rocking environment followed by a translation environment
15767261|NCT04717895|Diagnostic Test|Translation environment followed by a rocking environment|Start by the virtual reality session by viewing a translation environment followed by a rocking environment
15767262|NCT04717882|Device|CDSS-OPTIMED|The CDSS-OPTIMED is a software program that provides the physician with a personalized alert on whether to consider stopping or starting medication for a specific patient.
15767263|NCT04717869|Diagnostic Test|Ultrasound|2D ultrasound image collection
15767264|NCT04717869|Diagnostic Test|Biomarker Analysis|Inflammatory and nutritional biomarker analysis
15767265|NCT04717869|Other|Frailty Index|A Frailty Index Questionnaire be completed by patients or their surrogates to determine the presence of frailty at ICU admission
15767266|NCT04717856|Other|screening: HCV RNA test and risk factors questionaire|Screening by using a rapid finger prick test for HCV RNA and a questionnaire to assess risk factors.
15767404|NCT04716907|Biological|Blood sample|Dosage of sj/βTREC ratio, lymphocytes, cytokines and chemokines.
15767267|NCT04717843|Other|4D Flow MRI|Acquisitions of MR imagining with special contrast phase CMR sequences. There is no need for agent contrast injection. The CMR is performed at the time of inclusion.
15767268|NCT04717843|Other|Medical consultation with 12 leads ECG|Collection of medical history, treatment, physical examination and realization of a 12 leads ECG.
15767269|NCT04717843|Other|Holter ECG|48 hours ECG recording
15767270|NCT04717843|Other|Trans thoracic echocardiography|Trans thoracic echocardiography with standard measures performes in the core lab.
15767271|NCT04717843|Biological|Blood sample|Blood sample in a peripheral vein, send to medical laboratory to dosage of NT pro BNP and troponin serum level.
15767272|NCT04717843|Other|Standard MRI|Acquisitions of MR imagining
15767273|NCT04717830|Drug|Gamezumab|solution for infusion
15767274|NCT04717817|Device|Inspiratory muscle training (IMT) using an IMT Threshold device (Philips)|Inspiratory muscle training on a daily basis prior to surgery during 2-3 weeks
15767275|NCT04717817|Other|Standard physiotherapy|Standard instructions and physiotherapy prior to surgery during 2-3 weeks
15767276|NCT04717804|Other|AIP CT|An image taken over a longer time of the lungs (average intensity projection of 4DCT) will be compared with breathing during treatment.
15767277|NCT04717804|Other|FB (Free-Breathing) CT|A snapshot of breathing (free-breathing traditional CT) will be used to compare with breathing during treatment.
15767278|NCT04717791|Device|Vivaer® ARC Stylus|The Vivaer procedure will be performed in the study clinic using the VivAer Stylus and Aerin Console. The VivAer Stylus is a disposable handheld device capable of delivering low-temperature bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants will have both nasal valves treated in a single study procedure session. Each nostril will be treated at up to 3 positions
15767279|NCT04717778|Dietary Supplement|Comparison of salivary pH after consuming milk of origin vegetable vs cow's milk|They were given 5 types of milk, each one was measured on different days (Monday cow's milk, Tuesday coconut milk, Wednesday almond milk, Thursday soy milk, Friday rice milk).
15767280|NCT04717765|Device|Preventive, LLL Phototherapy and topical Vit E|Interventions will be carried out for patients who have already passed or will undergo anti-neoplastic chemotherapy or radiation therapy.
15767281|NCT04717765|Device|Curative, LLL Phototherapy and topical Vit E|Interventions will be carried out for patients who have already passed or will undergo anti-neoplastic chemotherapy or radiation therapy.
15767282|NCT04717765|Device|Preventive, LLL Phototherapy and LPRF|Interventions will be carried out for patients who have already passed or will undergo anti-neoplastic chemotherapy or radiation therapy.
15767283|NCT04717765|Device|Curative, LLL Phototherapy and LPRF|Interventions will be carried out for patients who have already passed or will undergo anti-neoplastic chemotherapy or radiation therapy.
15767284|NCT04717752|Drug|Ovidrel|recombinant human chorionic gonadotropin for injection
15767285|NCT04717752|Drug|Troprilin|triptorelin acetate injection
15767286|NCT04717739|Device|TTFields|Tumor Treating Fields (TTFields) help slow down or stop glioblastoma cancer cells from dividing by disrupting dividing mechanism of cancer cells leading to apoptosis. TTFields are low-intensity, intermediate frequency, alternating electric fields delivered continuously through adhesive patches, called transducer arrays, to the area of the brain where the GBM tumor is located. These transducer arrays are applied to the scalp and are connected to the wearable and portable device. TTFields are approved for the treatment of newly diagnosed and recurrent GBM.
15767287|NCT04717726|Dietary Supplement|Milk Thistle (MT)|Participants in the MT and EX + MT groups will be provided 900 mg of standardized milk thistle extract daily (300 mg three times per day before meals) over the 12-week regimen. We will use the standardized Jarrow Formulas Milk Thistle Veggie Caps containing 30:1 extract that is standardized to contain 80% total Milk Thistle seed flavonoids (polyphenols), including the critical Silymarin fractions isosilybinins A and B, silybinins A and B, silychristin and silydianin that is active against suppressing the UGT1A1 enzyme increasing plasma bilirubin. The capsules are free of wheat, gluten, soybeans, dairy, egg, fish/shellfish, peanuts/tree nuts, and GMOs. Rationale for using this brand: There have been inconsistencies with previous studies that did not use a standardized silymarin extract, which may have contained low levels of the active polyphenolic flavonoids in the milk thistle plant, which varies in the plant's stems, leaves, roots, and flowers.
15767288|NCT04717726|Dietary Supplement|Lactobacillus Gasseri (LAC)|Participants in the LAC and LAC + EX groups will receive two doses of 3 billion CFU of lactobacillus gasseri per day for a total of 6 billion CFU, the recommended upper level for supplementation of probiotic cultures. We will use Swanson brand Lactobacillus gasseri, whose capsules are also free of wheat, gluten, soybeans, dairy, egg, fish/shellfish, peanuts/tree nuts, and GMOs. Importantly, this brand uses acid-resistant designed release capsules to improve the viability of the lactobacillus in the human stomach.
15767289|NCT04717726|Behavioral|Exercise (EX)|Participants in the EX, EX + MT, and EX + LAC groups will complete five weekly exercise sessions on their own, expending roughly 600 kcal per session. Participants will be provided a Polar A-300 heart rate monitor programmed for their individual attributes (height, weight, age, training status, gender), which gives a real-time estimate of energy expenditure during exercise. Participants will report to the lab once per week to download the exercise sessions and verify compliance. If participants are not compliant (defined as completing 85% of their assigned exercise sessions per month), they will be disqualified. This intervention has been successfully used by Dr. Flack in multiple studies to produce significant weight loss without dietary intervention in this population with a retention rate of over 90%
15767290|NCT04717726|Dietary Supplement|Control (CON)|Participants in the CON and EX group will receive a placebo (maltodextrin) made to look identical to the MT and LAC capsules.
15767291|NCT04717713|Drug|steroid injection|steroid injection at surgical location
15767292|NCT04717713|Drug|placebo|saline injection at surgical location
15767293|NCT04717700|Drug|Selinexor 20 MG Oral Tablet|Comparing an alternating regimen of selinexor-lenalidomide/bortezomib-dexamethasone to standard bortezomib-lenalidomide-dexamethasone
15767294|NCT04717700|Drug|Bortezomib Injection|Comparing an alternating regimen of selinexor-lenalidomide/bortezomib-dexamethasone to standard bortezomib-lenalidomide-dexamethasone
15767295|NCT04717700|Drug|Lenalidomide capsule|Comparing an alternating regimen of selinexor-lenalidomide/bortezomib-dexamethasone to standard bortezomib-lenalidomide-dexamethasone
15767405|NCT04716907|Diagnostic Test|CT Scan|Thymus and lung imaging
15767296|NCT04717700|Drug|Dexamethasone Oral|Comparing an alternating regimen of selinexor-lenalidomide/bortezomib-dexamethasone to standard bortezomib-lenalidomide-dexamethasone
15767297|NCT04717687|Procedure|Irreversible electroporation|Device: NanoKnife The aim of the treatment is to surround the tumour with two to six needles and to deliver a very high voltage current (3000 volts in 70 to 80 microseconds pulses) by a generator synchronized with an electrocardiogram.
15767298|NCT04717674|Drug|[18F]Fluoropivalate ([18F]Fluoro-2,2-Dimethylpropionic Acid)|[18F]FPIA radiotracer administration
15767299|NCT04717674|Procedure|PET/CT|PET/CT scan
15767300|NCT04717648|Diagnostic Test|Biochemical test|C Reactive protein and sodium
15767301|NCT04717635|Biological|Canakinumab|Provide as 150 mg/1 mL solution for subcutaneous injection and administer 4mg/kg every 4 weeks.
15767302|NCT04717609|Procedure|Saphenous Nerve Block|Preoperative Saphenous Nerve Block for partial Meniscectomy
15767303|NCT04717609|Drug|Ropivacaine injection|preoperatively the participant will receive an injection ar the surgical site of 5 milliliters (mL) of 0.5% ropivacaine
15767304|NCT04717596|Other|BC4Teens Care|Healthcare providers will be trained in contraceptive counseling and provision.
15767305|NCT04717583|Procedure|Intense pulsed light (IPL) treatment|"After randomization, one side of the face will be treated with IPL using the M22™ Universal IPL device, once every 4 weeks for 3 consecutive times.
~Starting from Week 12 (the time point of the primary endpoint), the control side of face will also be treated by IPL if the IPL-treated side shows satisfactory improvement of erythema or telangiectasia by IPL treatment. If the patient was unsatisfied with the improvement in the IPL-treated side at Week 12 visit, no IPL treatment will be given to either side of the face any more."
15767306|NCT04717570|Device|Foldax TRIA Mitral Valve|Mitral Valve Replacement
15767307|NCT04717557|Drug|Hyperbaric Oxygen|Hyperbaric oxygen (HBO2) 1-2 times daily for up to 10 times after amputation
15767308|NCT04717544|Behavioral|Intervention Arm|The smoking cessation intervention will include 1) a six-week, 60-75 minute weekly cognitive-behavioral therapy (CBT) smoking cessation counseling group; and 2) smoking cessation medication include varenicline (Chantix), bupropion (Zyban) and nicotine replacement therapy (NRT). Dispensing these medications will include a 15-minute medication management visit with a prescribing clinician. Clients will choose their own preferred treatment. The standard prescription for NRT will include a transdermal patch at a dose that approximates for current average mg of nicotine intake and nicotine gums or lozenges (in either 2 mg or 4 mg strengths). Prescription for varenicline will be 0.5 mg once daily for three days, then 0.5 mg twice daily for the next four days, then 1 mg twice daily thereafter. Absent any contraindications to the drugs listed above, bupropion (Zyban) 150mg will be offered and prescribed once daily for one week, following by bupropion 300 mg once daily thereafter.
15767309|NCT04717531|Drug|Pyrotinib|400mg, qd, po, day 1-21
15767310|NCT04717531|Drug|Trastuzumab|6 mg/kg, day 1
15767311|NCT04717531|Drug|Pertuzumab|420 mg, day 1
15767312|NCT04717531|Drug|Docetaxel|100 mg/m2, day 1
15767313|NCT04717531|Drug|Epirubicin|90mg/m2, day 1
15767314|NCT04717531|Drug|Cyclophosphamide|600 mg/m2, day 1
15767315|NCT04717518|Other|Measurement of Pain|Patients will fill out a brief survey concerning the current visit to the ED.
15767316|NCT04717505|Other|Gait Assessments|"10 Meter Walking Test: It is applied by walking at a normal walking speed (like walking in a shopping mall) without any assistance at a marked distance of 10 meters.
~1- Evaluation of walking under single task conditions is done with the 10 Meter Walk Test and without any cognitive or motor second task. Evaluation of walking under dual task conditions is applied in two different ways: 2-adding a cognitive task to the walking motor task (motor + cognitive dual task) 3-adding one more motor task to the walking motor task (motor + motor dual task). While performing dual tasks, the time-distance (walking speed, cadence, stride length) characteristics of the gait are recorded using with wearable gait device."
15767317|NCT04717505|Other|Arthritis Impact Measurement Scales 2|It is a multidimensional, disease-specific, self-administered questionnaire designed to measure health status outcomes in patients with arthritis.
15767318|NCT04717505|Other|Visual Analogue Scale|The Visual Analogue Scale is a reliable and easily applicable scale used to measure the pain intensity of patients, accepted in the world literature.
15767319|NCT04717505|Other|Standardized Mini Mental Test|Although the test has limited specificity in terms of differentiating clinical syndromes, it is a short, useful and standardized method that can be used to determine the cognitive level globally.
15767320|NCT04717492|Other|Observational|Observational
15767321|NCT04717479|Other|Intervention (videoconferencing)|1 hour videoconferencing sessions over 8 weeks with an English language learner partner.
15767322|NCT04717466|Biological|Secukinumab|300mg subcutaneous injection
15767326|NCT04717401|Procedure|Strain-Counterstrain|Strain-counterstrain will be applied to four muscle which are . Tender point of each muscle will be identified then the muscle will be positioned passively in the most relaxed position which will be held for 90 sec. This procedure will repeated 3 times for each muscle
15767327|NCT04717401|Procedure|Muscle Energy Technique|Muscle energy technique will be applied to four muscles which are quadratus Lumborum, iliacus, piriform and erector spinae. Each muscle will be positioned passively in stretched position the patient asked to push against the therapist isometrically while holding breath for 5-10sec. After exhalation, the muscle will be moved into a new barrier. This procedure will repeated 3 times for each muscle
15767328|NCT04717388|Other|acoustics tests, Questionaries,|"acoustics tests at V1 Questionaries at V1
~cognitive
~emotional
~auditory"
15767329|NCT04717388|Radiation|MRI|Anatomical and functional MRI at V2
15767330|NCT04717375|Drug|BND-22|Monoclonal antibody administered intravenously
15767331|NCT04717375|Drug|Pembrolizumab|Monoclonal antibody administered intravenously
15767332|NCT04717375|Drug|Cetuximab|Monoclonal antibody administered intravenously
15767333|NCT04717362|Drug|Natesto Nasal Product|Nasally administered exogenous 4.5% testosterone gel, administered from a non-pressurized, manual pump dispenser equipped with a specialized nasal applicator which administers 125uL (5.5mg of testosterone).
15767406|NCT04716907|Biological|Bronchial fibroscopy|Bronchoalveolar lavage in mechanically ventilated patients for dosage of recent thymic emigrants in lungs
15767334|NCT04717336|Other|SODIUM CHLORIDE|It is well established that increased dietary sodium can predispose to an increase in blood pressure; particularly in salt-sensitive individuals. Seeking to test the hypothesis that changes in dietary sodium intake are sufficient to influence the composition of the gut microbiome in association with sodium-induced changes in vascular function, epigenome, transcriptome and blood pressure in African Americans.
15767335|NCT04717336|Other|placebo|placebo capsules, salt treatment
15767336|NCT04717323|Device|mPAD (or TPAD) Pelvic Assist Device|Gait retraining device that applies pelvic forces and measures response
15767337|NCT04717323|Device|No Intervention|Gait with no pelvic assistance
15767338|NCT04717310|Drug|SHR0302 Ointment|SHR0302 Ointment Twice a day (BID)
15767339|NCT04717310|Drug|SHR0302 Ointment|SHR0302 Ointment Twice a day (BID)
15767340|NCT04717310|Drug|SHR0302 Ointment|SHR0302 Ointment Twice a day (BID)
15767341|NCT04717310|Drug|Vehicle|Twice a day (BID)
15767342|NCT04717297|Behavioral|Medication Management Intervention|First, the study pharmacist reviews the older adult's medication for potentially inappropriate medications. The pharmacist collaborates with the prescribing physician(s) to deprescribe as indicated. The pharmacist educates the older adult and OT on any changes that were made. The OT and older adult will develop a plan to reduce risk factors and improve medication management. Participants receive tailored compensatory strategies and supports to remediate extrinsic risk factors and modify the home environment to improve medication adherence. The OT provides training and active practice of the compensatory strategies and supports in the home in an effective and safe manner.
15767343|NCT04717297|Behavioral|Attention Control|A trained research assistant will complete two attention control visits in the homes of participants. Visit will consist of semi-structured interview exploring the participant's life history.
15767344|NCT04717284|Other|Self-compassion intervention (SCI)|All participants will be asked to recall a recent parenting event they feel ashamed of and type it into a text box provided. Participants in the SCI group will then be instructed to reflect on their recalled parenting event and prompted to think about and write about the event in a self-compassionate manner. The prompt is designed to induce on all of the three key elements of self-compassion described by Neff (2003a): self-kindness; common humanity; and mindfulness. The same instructions will be provided for follow-up period.
15767345|NCT04717284|Other|Control condition|All participants will be asked to recall a recent parenting event they feel ashamed of and type it into a text box provided. Participants in the control group will then be instructed to make notes about factual information of the event (e.g. time of day, who was there, the weather, etc.). During the two-week follow-up period, participants in the control group will not take part in any intervention as part of the trial.
15767346|NCT04717271|Other|Movement Guidance Group|"Participants of the MVG will received kinesthetic stimuli by manual assistance of the physiotherapist, which has the intention of guiding and improving the quality of movement during XBOX Kinect training for balance and gait.
~Each session consisted of 10 minutes of warm-up and 40 minutes of XBOX Kinect training, using 4 different exergames."
15767347|NCT04717271|Other|No Movement Guidance Group|"Participants of the NO-MVG will not received kinesthetic stimuli by manual assistance of the physiotherapist during XBOX Kinect training for balance and gait.
~They will perform the exercises without any manual correction. Although, the physiotherapist will be present during all session to ensure their safety.
~Each session consisted of 10 minutes of warm-up and 40 minutes of XBOX Kinect training, using 4 different exergames."
15767348|NCT04717258|Other|Fire and Rescue Service Safe and Well Visit|Safe and Well Visits by the Fire and Rescue Service to prevent falls and improve quality of life in an older population
15767349|NCT04717258|Other|Self-Determination Theory informed trial invitation letter|Invitation letter to take part in the FIREFLI study informed by Self-Determination Theory
15767350|NCT04717258|Other|Pen included with reminder questionaire|A pen will be included with the four-month reminder questionnaire.
15767351|NCT04717245|Drug|Promestriene Vaginal|Patients used promestriene vaginal cream for 3 months. The use was recommended to be diary fot the first 2 weeks, and then, repeat every 3 days.
15767352|NCT04717245|Other|Fractional CO2 LASER|"LASER treatment with fractional CO2 Laser was performed in 3 sessions with intervals of 4 weeks between them. Before each session, the patients underwent specular examination.
~Fractional CO2 LASER was applied following these parameters, fixed in all sessions: vagina wall - power40 W, dwel time 1000 mcs, spacing 1000 mcm and stack 2, vestibule - power 10W, dwel time 500mcs, spacing 300mcg and satck 1"
15767353|NCT04717245|Other|Microablative Fractional radiofrequency|"Microablative fractional radiofrequency was performed with the equipment calibrated in FRAXX mode, 45W, Low Energy program 40 milliseconds in the vaginal and introitus wall. Lidocaine spray was applied to vaginal introitus before the procedure.
~The patient was in the gynecological position. The vaginal speculum was placed and, afterwards, the vaginal antisepsis was performed with aqueous chlorhexidine and cleaning with 0.9% saline solution.
~All liquid contents were wiped off before beginning the procedure. The fractured tip will be pressed lightly and as perpendicular as possible into the vulvar or vaginal surface, ensuring full contact of all points in the tissue, starting at the lateral vaginal walls and from the proximal to the distal third."
15767354|NCT04717232|Other|Blended learning approach to mentoring education for dental health care professionals|The participants in the intervention group are dentists´ and dental hygienists´. The mentoring education for dental health care professionals (3 ECTS credits) will be organized by the program leader in Dentistry at the place-blinded. The aim of the mentoring education is to build understanding of how to support a student's professional development (both basic education and specialization) and transfer skills that are relevant to working as an independent expert in oral health care.
15767355|NCT04717232|Other|The interprofessional online mentoring education|The participants in the intervention group are dentists´ and dental hygienists´. The interprofessional online mentoring education (3 ECTS credits) will be organized in collaboration with the Finnish Dental Association in an online environment. The aim of the intervention is to in-crease mentors' competence in guidance processes and interactions, supporting students´ goal-oriented learning and professional evaluation, and providing constructive feedback.
15767356|NCT04717219|Other|Blood drawing|Blood will be drawn after inclusion of the participants.
15767357|NCT04717206|Other|Plyomtric training to male badmninton players|"Plyometric training has been proven to be effective and effecient in developing strength and speed.
~plyometric training includes different types hops,jumping,drills."
15767358|NCT04717206|Other|Plyomtric training to female badmninton players|"Plyometric training has been proven to be effective and effecient in developing strength and speed.
~plyometric training includes different types hops,jumping,drills."
15767359|NCT04717193|Drug|Rectus Sheath Block with 0.25% bupivicaine with 1:200 000 epinephrine|Bilateral rectus sheath block plus infiltration local anesthetic at incision sites.
15767360|NCT04717193|Procedure|Local Anesthetic Infiltration with 0.25% bupivicaine with 1:200 000 epinephrine|Infiltration of local anesthetic at incision sites.
15767361|NCT04717180|Behavioral|aphasia rehabilitation using software program or conventional therapy|Patients were randomized into two groups: group I who received therapy using the software aphasia rehabilitation program and group II who received conventional (traditional) language therapy
15767362|NCT04717167|Other|Dry Needling|
15767363|NCT04717167|Other|Sham Needling|
15767364|NCT04717154|Biological|Ipilimumab|4 courses of 1mg/kg q3w
15767365|NCT04717154|Biological|Nivolumab|4 courses of 3mg/kg q3w, followed by maintenance flat dose (480mg, q4w, for 10 doses)
15767366|NCT04717141|Other|Selective nerve block|"D0 :
~Information, collection of consent, inclusion,
~Clinical and instrumental evaluation,
~Realization of the selective nerve block,
~Post-selective nerve block clinical and instrumental re-evaluation,
~Performance of the botulinum toxin injection if indication selected.
~D28 (+/-5 days) :
~- Clinical and instrumental post-botulinum toxin injection evaluation."
15767367|NCT04717128|Other|Breastfeeding Skills Workshop|Participants will complete the standardized patient-led breastfeeding skills workshop where they will learn breast massage techniques to alleviate plugged ducts and engorgement, hand expression of breast milk, effective breast pump use, and newborn positioning and attachment.
15767368|NCT04717115|Genetic|Genetic diagnosis|No Intervention foreseen, but genetically confirmed diagnosis of PCD (bi-allelic mutations in a gene, known to cause PCD) with typical clinical symptoms of PCD and at least one other method confirming PCD-diagnosis is needed
15767369|NCT04717102|Drug|0.5 MAC desflurane|Following induction of anesthesia by propofol, the patients will be maintained on 0.5 MAC desflurane with remifentanil infusion during spinal surgery.
15767370|NCT04717102|Drug|0.75 MAC desflurane|Following induction of anesthesia by propofol, the patients will be maintained on 0.75 MAC desflurane with remifentanil infusion during spinal surgery.
15767371|NCT04717102|Drug|1.0 MAC desflurane|On completion of the neuromonitoring phase of surgery, the patients will be maintained on 1.0 MAC desflurane with remifentanil infusion.
15767372|NCT04717089|Other|overnight intensive recovery / extended post anaesthetic care in PACU|From January 2020, during COVID-19 first pandemics in Hong Kong, a bundle of interim measures was implemented with the joint efforts of the Department of Anaesthesia and Operating Theatre Services (A&OT) and Intensive Care Unit (ICU), and two ordinary recovery beds were converted into extended post anesthetic care in PACU (ExRR), based on the concept of overnight intensive recovery (OIR) to provide level 2 intensive care to patients undergoing major or ultra-major operations or having multiple comorbidities warranted intensive care in the immediately postoperative periods. This was conducted over 3 pandemic waves in Hong Kong.
15767373|NCT04717076|Behavioral|App-based nutritional concept and fitness tracking|The App-based nutritional concept based on menu plan, which are personalized according to participants age, gender, physical activity. The App is coupled with a Smartwatch to encourage and track physical activity over the study period.
15767374|NCT04717076|Behavioral|Nutritional concept with individual nutritional counselling|Nutritional concept based on personalized menu plans and individual nutritional counselling every four weeks (4 times during the study)
15767375|NCT04717076|Behavioral|Nutritional concept without individual nutritional counselling|Nutritional concept based on personalized menu plans
15767376|NCT04717063|Drug|Peroxyl Oral Product|mouth wash
15767377|NCT04717063|Drug|Placebo|placebo mouth wash
15767378|NCT04717050|Behavioral|Progressive combine training (PCT)|8 month exercise program with 4 month follow up.
15767379|NCT04717050|Behavioral|Attention Control (AC)|12 month stretching program
15767380|NCT04717037|Biological|Olive Oil Massage|olive oil massage application.
15767381|NCT04717024|Device|Observational Study - no intervention|Observational Study - no intervention
15767382|NCT04717011|Diagnostic Test|PCR test|PCR test in two different semen samples from each patient: first with positive diagnosis for COVID-19 and the second after negative diagnosis for COVID-19.
15767383|NCT04716998|Biological|MesenCure|Three administrations of MesenCure in addition to standard care
15767386|NCT04716972|Other|survey|Online survey
15767387|NCT04716972|Other|Interview|Interview
15767388|NCT04716959|Procedure|Prepectoral Prosthetic Breast Reconstruction|The prepectoral approach involves placing the tissue expander on top of the pectoralis muscle.
15767389|NCT04716959|Procedure|Subpectoral Prosthetic Breast Reconstruction|The subpectoral approach involves placing the tissue expander under the pectoralis muscle with or without acellular dermal matrix (ADM).
15767390|NCT04716946|Drug|Durvalumab|Patients will receive durvalumab 1500mg durvalumab via IV infusion over 1 hour, once every 4 weeks (Q4W) for up to a maximum of 6 months (up to 6 doses/cycles) unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met.
15767391|NCT04716946|Radiation|Stereotactic Body Radiation Therapy|Radiation therapy will be performed with external beam ionizing radiation in accordance with institutional standard practice. 3D conformal radiation therapy (3D-CRT), intensity-modulated radiation therapy (IMRT) or volumetric arc therapy (VMAT) will be used at the discretion of the treating radiation oncologist.
15767392|NCT04716933|Biological|Pembrolizumab|IV infusion Q3W
15767393|NCT04716933|Drug|Carboplatin|IV infusion Q3W
15767394|NCT04716933|Drug|Cisplatin|IV infusion Q3W
15767395|NCT04716933|Drug|Pemetrexed|IV infusion Q3W
15767396|NCT04716933|Drug|Lenvatinib|Oral capsule once daily
15767397|NCT04716933|Drug|Placebo matching lenvatinib|Oral capsule once daily
15767398|NCT04716920|Other|Tai Chi|Attend Tai Chi exercise classes
15767399|NCT04716920|Device|FitBit|Wear FitBit
15767400|NCT04716920|Other|Support Group Therapy|Join Tai4Chijoint group
15767401|NCT04716920|Other|Questionnaire Administration|Ancillary studies
15767409|NCT04716881|Drug|Naltrexone 380 MG|Vivitrol (naltrexone) 380 mg delivered intramuscularly every 28 days
15767410|NCT04716868|Dietary Supplement|Agave Fructans 5 g|Agave tequilana Weber blue variety 5 g once a day for 8 weeks
15767411|NCT04716868|Dietary Supplement|Agave Fructans 10 g|Agave tequilana Weber blue variety 10 g once a day for 8 weeks
15767412|NCT04716868|Dietary Supplement|Agave Fructans 5 g + Maltodextrin 10 g|Maltodextrin 10 g + Agave tequilana Weber blue variety 5 g once a day for 8 weeks
15767413|NCT04716868|Dietary Supplement|Psyllium plantago|Psyllium plantago 15 g once a day for 8 weeks
15767414|NCT04716855|Other|Quality of life and daily living activities assessment tests|
15767415|NCT04716829|Device|LUNA-EMG|The LUNA-EMG (Samcom) system is a robot that allows the evaluation of muscular strength through the recording of muscle activity (electromyography - EMG) in order to provide precise objective data on the patient's muscle function. In addition to the diagnostic aspect (evaluation of muscle strength, range of motion and proprioception), the LUNA-EMG robot allows the adaptation of movements during rehabilitation sessions according to the individually generated strength.
15767416|NCT04716816|Procedure|Stripping massage|Stripping massage for rhomboid myofascial trigger points
15767417|NCT04716803|Biological|Bone Marrow Aspirate Concentrate|Aspiration of bone marrow will be collected from the patient's pelvic bone region and subsequently concentrated with the Angel Concentrated Platelet Rich Plasma (cPRP) System.
15767418|NCT04716803|Device|Angel Concentrated Platelet Rich Plasma (cPRP) System|Aspiration of bone marrow will be collected from the patient's pelvic bone region and subsequently concentrated with the Angel Concentrated Platelet Rich Plasma (cPRP) System.
15767419|NCT04716790|Procedure|Ultrasound Debridement|Ultrasounds debridement is performed using an SONOCA 185 device (Söring GmbH, Germany). The ultrasounds device generates an ultrasound low frequency of 25kHz and is equipped with three instruments with different sonotrode shapes. The choice of sonotrode depends on wound depth. The ultrasounds instrument piezoelectrically transforms the electrical energy delivered from the ultrasound device into mechanical oscillations in the sonotrode tip.
15767420|NCT04716790|Procedure|Conventional Treatment|Conventional Treatment based on international guidelines for diabetic foot
15767421|NCT04716777|Behavioral|Brief Transdiagnostic group-based Cognitive-Behavioral Treatment|Weekly group-based transdiagnostic CBT sessions for eight weeks.
15767422|NCT04716764|Other|3-Day Food Intake Record|Collecting clinical and socio-demographic information, nutritional status, food consumption (dietary intake of advanced glycation end products, dietary total antioxidant capacity, dietary inflammatory index), anthropometric measurements (body weight, height, body composition, handgrip strength, upper-middle arm circumference, waist circumference, hip circumference, triceps skinfold thickness), quality of life, biochemical biomarkers (serum carboxymethyl lysine, advanced glycation end products receptor, the soluble receptor of advanced glycation end products, TNF-α, IL-1β, IL-6, malondialdehyde, 2,4-dinitrophenyl hydrazine, 8-hydroxy-2'-deoxyguanosine, total antioxidant capacity)
15767423|NCT04716751|Drug|Toripalimab|"Neoadjuvant treatment stage: Toripalimab 240mg, Carboplatin AUC5+ paclitaxel 200 mg/m ², iv, 3 weeks per cycle, 2-4 cycles in total; Surgical treatment stage: Patients with tracheal malignant tumor received radical surgery after neoadjuvant therapy, and patients who could not or refused surgical treatment due to various reasons were treated with multidisciplinary discussion.
~Adjuvant treatment stage: Toripalimab 240mg, Carboplatin AUC5+ paclitaxel 200 mg/m ²,iv, up to 4 cycles (including neoadjuvant stage)."
15767424|NCT04716738|Diagnostic Test|Blood analyses and coprological|We will take a blood and stool sample
15767425|NCT04716725|Drug|68Ga-PSMA-11|Given IV
15767426|NCT04716725|Procedure|Positron Emission Tomography (PET)|Undergo PET
15767427|NCT04716712|Drug|Azithromycin|Azithromycin is a macrolide-type antibiotic that is used to treat various types of infections. Previous studies in Niger have demonstrated a nearly 18% reduction in all-cause child mortality following biannual mass administration to children 1-59 months.
15767428|NCT04716712|Drug|Placebo|Matching identical placebo in packaging, appearance, and taste.
15767429|NCT04716699|Procedure|Biospecimen Collection|Undergo collection of blood and tumor samples
15767430|NCT04716699|Drug|Lidocaine|Given IV
15767431|NCT04716699|Procedure|Resection|Undergo surgical resection per standard of care
15767432|NCT04716686|Drug|Niraparib|Patients received oral niraparib 200/300 mg QD and every cycle (28 days) thereafter until disease progression.
15767433|NCT04716673|Other|Down-phase targeted auditory stimulation|The presentation of a soft, brief tone (50 ms of pink noise). The volume will be held low enough to avoid provoking arousals or awakenings. In case of a waking-up-reaction, the volume will be lowered in steps of 5 dB.
15767434|NCT04716660|Other|Sensory block level check|Patients will have their sensory block level checked multiple times following administration of their epidural bolus for labor analgesia.
15767435|NCT04716647|Other|Ayurveda|Dosage was used in common range (Ashwagandha: Doses range from 250 mg to 5 g; Giloy: range from 500mg to 1g; Tulsi: 500mg-1g) Dosage were altered based on age, weight and severity of symptoms.
15767436|NCT04716634|Drug|Tislelizumab|Tislelizumab is a humanized, immunoglobulin G4 (IgG4)-variant monoclonal antibody against PD 1.
15767437|NCT04716634|Drug|Fruquintinib|Fruquintinib is a potent, oral VEGFR tyrosine kinase inhibitor (TKI)
15767438|NCT04716621|Other|Early intervention|"The Pain Management Support System for Primary Care (PMSS-PC) generated best practice alerts and gave clinicians access to a pain assessment template, measures of psychological distress and substance use, guidelines for drug and non-drug therapies, and facilitated referrals. At implementation, clinicians at the practices were offered in-person and virtual education through six webinars on best practices for pain."
15767439|NCT04716621|Other|Delayed intervention|Delayed wait-list control group. The second arm involved three additional sites receiving the PMSS-PC intervention 6 months after the first arm. Initial outcomes from the PMSS-PC Experimental Intervention arm were compared to those of this Wait-list Control arm.
15767440|NCT04716608|Other|physiotherapy program|"physiotherapy program with Myofascial Release Massage, stretching, strengthening.
~2 sessions per week (duration 30 minutes per session) for 8 weeks, supervised by a physiotherapist; complemented by a home training program."
15767441|NCT04716608|Other|usual care treatment|stretching,strengthening; 2 sessions per week (duration 30 minutes per session) for 8 weeks
15767442|NCT04716595|Drug|K-877 ER 0.2 mg/day morning administration (once daily)|K-877 ER 0.2 mg tablet
15767443|NCT04716595|Drug|K-877 ER 0.2 mg/day evening administration (once daily)|K-877 ER 0.2 mg tablet
15767444|NCT04716582|Behavioral|Sitting interrupted by light physical activity|Each 30 minutes will be 25 minutes sitting followed by 5 minutes walking that designed as prescribed walking route outside laboratory corridor.
15767445|NCT04716582|Behavioral|Sitting with cognitive task|Participants will perform online cognitive task during prolonged sitting.
15767446|NCT04716582|Behavioral|uninterrupted sitting|Participants will watch documentary during prolonged sitting.
15767447|NCT04716569|Drug|intranasal ivermectin spray|usage of ivermectin as intranasal spray for treating early covid patiens
15767448|NCT04716556|Biological|Convalescent plasma|Convalescent plasma will be collected by healthy donors, recovered by COVID19 and, after standard preparation and dosage of neutralizing antibodies, it will be administered to patients with SARS-CoV2 pneumonia
15767449|NCT04716543|Diagnostic Test|ILI and COVID-19 detection|"All participants presenting with ILI symptoms will have non-invasive exam for SARS-CoV-2 detection (nasal, throat, swab, saliva) and a questionnaire.
~All family members more than 6 months living with SARS-CoV-2 positive individuals will have will have non-invasive exam for SARS-CoV-2 detection (nasal, throat, swab, saliva) and a questionnaire."
15767450|NCT04716530|Other|No intervention is associated with the study.|No intervention is associated with the study.
15767451|NCT04716517|Other|Alkasite bioactive restorative material.|"Alkasite restorative is a category of filling material, like compomer, and is essentially a subgroup
~of the composite resin. Cention N is a urethane dimethacrylate (UDMA)-based, self-curing powder/liquid restorative with optional additional light curing. The liquid comprises of dimethacrylates and initiators, while the powder contains various glass fillers, initiators, and pigments. It is radio opaque and contains alkaline glass fillers capable of releasing fluoride, calcium, and hydroxide ions. Due to the sole use of cross-linking methacrylate monomers in combination with a stable, efficient self-cure initiator, Cention N displays a high polymer network density and degree of polymerization over the complete depth of the restoration."
15767452|NCT04716517|Other|Resin Modified Glass Ionomer|The resin-modified glass ionomer materials are hybrid materials of traditional glass ionomer cement with a small addition of light-curing resin, and hence exhibit properties intermediate to the two, with some characteristics superior to conventional glass ionomer materials
15767453|NCT04716491|Device|Intervention to decrease disruptive sleep in patients undergoing percutaneous intervention to treat cardiac disorders admitted to the ICU: ear protector and eye mask.|When they meet the inclusion criteria and accept to participate in the study, the interventionist nurse will explain to the patient the objectives and protocol of the study, apply the consent form and the instruments for assessing sleep (pittsburgh), trait and state anxiety (STAI). Then the software will be randomized and after defining the group, the nurse will guide the patient on the use of the devices from 9:00 am until the final awakening in the morning. Control group participants will only complete the assessment instruments. Noise and brightness will be measured at randomization of participants. The following morning, the visual sleep scale and the sleepiness scale will be applied for both groups, in addition to filling in information regarding the length of time the devices stay with patients at night and the clinical data that will be collected until discharge from the hospital. ICU, when independent of the group, the state anxiety instrument will be applied.
15767454|NCT04716478|Other|Clinical and radiological data collection|No specific intervention. Data of the usual care will be collected as the demographic data, the medical history, imaging report, etc.
15767455|NCT04716465|Other|Dysautonomia|Indicators of dysautonomia
15767456|NCT04716452|Drug|Ceramide NanoLiposome (Ceraxa)|Ceramide NanoLiposome will be given by IV twice a week. The dose, which is based on body size, will be increased for the next group of patients if the first group of patients tolerates that dose and it will decrease for the next group if they do not tolerate the dose.
15767457|NCT04716439|Procedure|Spine Surgery|spine decompression and fixation
15767458|NCT04716426|Drug|Tetracycline hydrochloride 3%|Proprietary formulation composed of FDA approved inactive ingredients and the active pharmaceutical ingredient tetracycline hydrochloride.
15767459|NCT04716426|Drug|Placebo|Formulation composed of FDA approved inactive ingredients.
15767460|NCT04716413|Drug|Dsuvia|Subject will receive up to 2 doses of Dsuvia. The first dose will be intra-op and the second dose will be post-op (if needed)
15767461|NCT04716400|Behavioral|Stop sexual harassment|Teachers will be introduced to a digital course on the prevention of sexual- and gendered harassment. In the course they will provided with a manual containing eight lessons to be held for the pupils. Each lesson will last 45 minutes and consist of a short film and practical activities for the pupils.
15767462|NCT04716387|Other|Standard LLIN|Long-lasting insecticidal net containing alphacypermethrin, a pyrethroid insecticide, and manufactured by Shobikaa Impex Private Limited.
15767463|NCT04716387|Other|Piperonyl butoxide ITN|Insecticide treated net containing permethrin, a pyrethroid, and piperonyl butoxide, an insecticide synergist, manufactured by Sumitomo Chemical.
15767464|NCT04716387|Other|Pyriproxyfen ITN|Insecticide treated net containing alpha-cypermethrin, a pyrethroid, and pyriproxyfen, an insect growth regulator, manufactured by Disease Control Technologies.
15767465|NCT04716387|Other|Chlorfenapyr ITN|Insecticide-treated nets containing two active ingredients: alpha-cypermethrin, a pyrethroid insecticide, and chlorfenapyr, a pyrrole insecticide, manufactured by BASF.
15767466|NCT04716374|Other|Tumor molecular profiling|Tumor tissue processing and all NGS genotyping were performed at the Laboratory of Molecular Oncology (Hellenic Foundation for Cancer Research / AUTH). Paraffin H&E sections from the retrieved tissue blocks were centrally reviewed for tumor histology and tissue adequacy for DNA extraction and were marked for macrodissection along with tumor DNA content [(former tumor cell content (TCC%)] assessment. DNA was extracted from macrodissected tissue fragments with the QIAamp® DNA mini kit (Qiagen, Hilden, Germany), measured in a Qubit fluorometer (Thermo Fisher Scientific, Paisley, UK), and genotyped with NGS in an Ion Torrent Proton sequencer (Thermo Fisher Scientific) by using a previously published custom panel (Kotoula, Lakis et al. 2019). Following stringent variant quality filtering (Kotoula, Chatzopoulos et al. 2021), 500 tumors
15767467|NCT04716348|Procedure|muscle energy technique|muscle energy technique for suboccipital muscles
15767468|NCT04716335|Drug|DMT|DMT (max. 100mg; intranasal over 120 minutes)
15767469|NCT04716335|Drug|Harmine|Harmine (100mg; sublingual)
15767470|NCT04716335|Drug|Placebo (Harmine)|Placebo for Harmine (sublingual)
15767472|NCT04716322|Behavioral|Adapted Physical Activity|A 16-week health-adapted physical activity program, individualized from baseline evaluation of participants including the specificities of their pathologies
15767473|NCT04716309|Procedure|Open reduction and volar locking plate and closed reduction and K-wires.|DVR Anatomic Plate, K-wires
15767474|NCT04716296|Drug|Ketamine|Ketamine will be given for the second stage of the DBS surgery.
15767475|NCT04716296|Drug|Saline|Saline will be given for the second stage of the DBS surgery.
15767477|NCT04716270|Procedure|Electrophysiology Study and Ablation|Electrophysiology Study and Ablation of Supraventricular Arrhythmias
15767478|NCT04716244|Other|interview/focus group/questionnaire|"Prior to the meetings, participants will be asked to fill in a questionnaire with demographic data including age, family status, number of pregnancies, number of children, education, and employment, history of preeclampsia or GDM, family history of CVD, and self-reported height and weight We will conduct up to 8 groups or until we reach saturation of themes. For the teleconference focus groups, the number of participants will be limited to 6 women per group, as recommended from previous research on teleconference focus groups51. The face to face focus groups will include up to -12 women. The expected duration of each group, will last 1-2 hours.
~We will conduct up to 36 in-depth interviews. The expected duration of each interview will last 30 minutes to -1.5 hours.
~Participants will be asked for their consent to record the meetings, audio only. The discussions will be then transcribed. An interview guide will be followed."
15767481|NCT04716218|Procedure|back up head elevated position|The patient was then placed in the back-up position to align the external auditory meatus and sternal notch, which was achieved by breaking the operating table at the hips to prevent patients from sliding off the table.
15767482|NCT04716205|Other|Mulligan Bent Leg Raise Technique|Participant will be in supine lying on a high couch with the resting on the shoulder. A distraction (longitudinal traction force along the long axis of femur) will be investigator in walk stand position lateral to the leg, which to be stretch. Hip and Knee of the side to be stretch will bent at 90˚- 90 ˚. Participant's flexed knee will be placed over the shoulder, the popliteal fossa of the knee applied at the lower end of femur and the participant will ask to push the shoulder with his or her leg followed by voluntary relaxation.The traction will maintained throughout the technique.
15767483|NCT04716205|Other|Static Stretching|It will be given in supine position by performing passive SLR and end range will hold in 30sec.
15767484|NCT04716192|Other|Positional release technique|"Positional Release Technique The subject lies supine with therapist standing on the affected side; tender points are located along the upper fibres of the trapezius. Pressure will applied by pinching the muscle between the thumb and fingers. The subject's head is laterally flexed toward the side of tender point, then therapist grasps the subject's forearm and abducts shoulder to approximately 90° a slight flexion or extension is added to obtain fine-tune. The ideal position of comfort achieved is held for a period of 90 seconds and followed by a passive return of the body part to an anatomically neutral position continued for 5 minutes.
~Mayofascial Release Technique Therapeutic Ultrasound"
15767485|NCT04716192|Other|Myofascial release technique & Ultrasound|"Myofascial Release Technique
~Position of the patient - sitting comfortably with supported back, elbow flexed with forearm placed on a pillow. A low load, long duration stretch is applied along the lines of maximal fascial restrictions. The fascia is palpated and the pressure is applied directly to the skin, into the direction of restriction just until resistance (tissue barrier) is felt. The pressure will be applied for 90 to120 seconds. This procedure will carried out without sliding over the skin or forcing the tissue until the fascia complex starts to yield and a sensation of softening is achieved.
~Therapeutic ultrasound with the frequency of 3Mhz , with continuous mode and an intensity of 0.1-1.5 W/cm2 for a duration of 5 min will given with the patient position back rest."
15767486|NCT04716179|Diagnostic Test|Sperm test|The semen sample will be collected and analyzed within an hour after collection.
15767487|NCT04716179|Diagnostic Test|hormone levels (testosterone, FSH, LH, prolactin)|Hormone levels (testosterone, FSH, LH, prolactin) will be assessed on 5-7 days after symptom onset until the end of hospital stay.
15767488|NCT04716179|Diagnostic Test|SARS-CoV-2 Ig G levels|SARS-CoV-2 Ig G levels will be assessed on 3 months after discharge
15767489|NCT04716179|Other|Testis pathology samples|Postmortem examination of the testes of patients deceased as a result of COVID-19 infection will be carried out using immunohistochemistry analysis.
15767492|NCT04716153|Other|Multifactorial sensory rehabilitation workshops|A multifactorial sensory rehabilitation Workshops : a multifactorial program in order to optimize the recovery of flavors, focused on smell and taste which integrates several non-drug interventions, which are part of the current recommendations: hydration of the mucous membranes with daily (3 times a day) liposomal sprays (nose and mouth), presentation of visual dishes.
15767493|NCT04716153|Other|Usual care|"The control group only receives the usual care provided for as part of routine care. It consists of a nutritional assessment at home by a dietician, with monitoring of intake and weight, in order to readjust nutritional support. A systematic search for oral mycosis is carried out in order to treat.
~The foods that the patient prefers, identified from a list of authorized foods, are preferred or even fortified."
15767541|NCT04715776|Dietary Supplement|placebo|Uptake of 1650 mg placebo twice daily
15767494|NCT04716153|Other|Tests and Questionnaire|fulfillment of Taste Strips Test, Sniffin'sticks test and FACT-BMT, HADS, PG-SGA, l'EVA des ingesta and GPAQ questionnaires to assess the quality of life of patients
15767495|NCT04716140|Procedure|Debridement of the MTP1 cartillage lesion and microfracture|Patients with a MTP1 cartillage lesion > grade I (based on based on the ICRS scale and an MS HoloLens measurement) randomised in the treatment group will be treated with debridement and microfracture
15767496|NCT04716127|Behavioral|Proximity-incentive strategy based on vaginal self-sampling for women 50 to 65 years who do not participate to cervical cancer screening|"Direct offer of a vaginal self-sampling kit with information to perform at home and send back to the laboratory for HR-HPV testing
~The psychosocial determinants involved in decision-making process and compliance to cervical cancer screening will be collected from open questionnaires and by semi-directive phone interviews
~Control ; Receive reminder to send the self-sample to the laboratory : After 3 and 6 months without return, women receive a remind letter to send the vaginal self-sample to the laboratory. We call return the receipt of the vaginal self-sample at the laboratory.
~Control ; Receive reminder to perform cervical smear in case of positive HR-HPV test : In case of a positive HR-HPV test, women are asked to perform a control cervical smear. After 3, 6 months and 12 months without return, women and their health-care professional will receive a remind letter to perform a cervical smear for control. We call return the performance of a pap smear."
15767497|NCT04716114|Drug|SKLB1028|SKLB1028 will be administered by oral capsules, 150 mg twice daily (BID).
15767498|NCT04716114|Drug|Salvage Chemotherapy|Low-dose cytarabine (LoDAC); azacytidine; homoharringtonine (HHT), cytarabine and aclarubicin (HAA) or fludarabine, cytarabine and granulocyte colony-stimulating factor (FLAG) will be administered by subcutaneous (SC) and/or intravenous (IV) injections.
15767499|NCT04716101|Other|Massage therapy technique|The massage therapy technique consists of manual deep and slow compression and shearing forces applied on the lumbar spine muscles and thoracolumbar fascia in a distal to proximal direction.
15767500|NCT04716101|Other|Sham massage technique|For the sham massage technique the massage therapist will put the right palm at the participant's right lower back along erector spinae and likewise left palm at left lower back without applying force, holding the palm during 2 minutes and half.
15767501|NCT04716088|Diagnostic Test|Rapid antigen test for SARS CoV2|Defining diagnostic performance of repeated testing regimen in hospital setting
15767502|NCT04716075|Drug|Acalabrutinib 2x100 MG Oral Capsule + alloSCT|Acalabrutinib 100 mg caps will be administered twice daily for 3-6 months before the intended alloSCT. After restarting acalabrutinib (2x100 mg daily) after the transplant procedure it will be administered for further 9 months. In patients who do not have an acceptable donor acalabrutinib will be administered until disease progression or unacceptable toxicity.
15767503|NCT04716062|Procedure|Open or Laparoscopic-assisted Colorectal surgery|Colorectal surgery
15767504|NCT04716049|Other|Powerade©, CHP, CJ, FR, CWI|"Combination of recovery strategies including dietary, neuromuscular and physiological as follows:
~Powerade©: players will drink 500 mL during the game
~Carbohydrate and protein (CHP): players will drink 250 mL of water with CHP within 30 minutes after the end of the game.
~Tart cherry concentrate (CJ): players will drink 30 mL of CJ within 30 minutes after the end of the game.
~Foam roller (FR): players will follow FR protocol using a polyvinylchloride pipe roller. They will begin with the FR at the most proximal portion of the muscle and to roll as much body mass as tolerable back and forth at a cadence of 1 second superior and 1 second inferior for 45 seconds followed by a 15-second rest for each muscle group (quadriceps, adductors, hamstrings, abductors and calf) in each extremity and repeated once.
~Cold Water Immersion (CWI): will be the last strategy used. Players will immerse their lower body to the level of hips for 10 minutes in cold water (13-14°C)."
15767505|NCT04716049|Other|Powerade©, CHP, STR, ICWI|"Combination of recovery strategies including dietary, neuromuscular and physiological as follows:
~Powerade©: players will drink 500 mL of Powerade© during the game
~Carbohydrate and protein intake (CHP): players will drink 250 mL of water with CHP within 30 minutes after the end of the competition.
~Stretching (STR): players will perform 10-min of static stretching, involving 2 unilateral repetitions of 30 seconds held stretches to the quadriceps, adductors, hamstrings, abductors and calf muscles.
~Intermittent Cold-Water Immersion (ICWI): will be the last strategy used. It will consist of five 2 min intermittent immersions of the lower limb (up to the iliac crest) in a cold-water bath (13-14ºC), separated by 2 min rest in ambient air. Ice will be added to the bath at regular intervals to maintain water temperature at 13-14ºC. Players will be instructed to stand in the bath, with as little movement as possible."
15767506|NCT04716036|Other|Alcohol beverage|Participants will be provided alcohol during study visits and changes in behavior/neural activity after consuming alcohol will be examined.
15767507|NCT04716036|Other|Placebo beverage|placebo beverage condition.
15767508|NCT04716010|Other|Control|Participants will complete a shopping task in the online grocery store, and the products that contain red meat will not have warning labels or a 30% increase in price.
15767509|NCT04716010|Other|Warning Labels|While completing the shopping task in the online grocery store, the health and environmental warning labels will appear next to the image of every product that contains red meat.
15767510|NCT04716010|Other|Tax|While completing the shopping task in the online grocery store, all products containing red meat will have a 30% increase in price.
15767511|NCT04716010|Other|Combined Warning Labels and Tax|While completing the shopping task in the online grocery store, all products containing red meat will have the health and environmental warning labels appear next to the product image and a 30% increase in price.
15767512|NCT04715997|Drug|GX-19N|DNA vaccine expressing SARS-CoV-2 S-protein antigen including the Nucleocapsid protein (NP) antigen
15767542|NCT04715763|Drug|Telmisartan Oral Product|Angiotensin Receptor Blocker (ARB) FDA approved for use in hypertension and for cardiovascular risk reduction
15767543|NCT04715763|Drug|Placebo|Gelatin capsules filled with an inactive ingredient
15767572|NCT04715555|Device|Electrocardiogram recording|Intermittent electrocardiogram (ECG) recordings taken using a wearable device on the wrist.
15767515|NCT04715971|Diagnostic Test|portable ultrasound bladder scan|A post-void residual volume was measured using a Verathon BladdersScan BVI 3000.
15767516|NCT04715958|Procedure|Contrast-Enhanced Ultrasound|Undergo CEUS
15767517|NCT04715958|Drug|Perflutren Lipid Microspheres|Given IV
15767518|NCT04715932|Drug|Hesperidin|Patients will receive study medication Hesperidin and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
15767519|NCT04715932|Drug|Placebo|Patients will receive study medication Placebo and will take 2 capsules of 500mg at the same time in the evening, at bedtime with water.
15767520|NCT04715919|Diagnostic Test|Chest Computed Tomography|Evaluation of Lung Structure
15767521|NCT04715919|Diagnostic Test|Pulmonary Function Tests|Respiratory Capacity
15767522|NCT04715919|Other|Six Minutes Walk Test|Exercise Capacity
15767523|NCT04715919|Other|Quality of Life|Physical disability assessment tool
15767524|NCT04715906|Behavioral|UP-Caregiver|The Unified Protocol (UP) is a telehealth group session using Zoom with each session lasting approximately 60-90 minutes. The sessions will focus on a variety of Cognitive Behavior Therapy techniques. These sessions may include teaching coping skills, goal setting, parent-child problem solving and communication, and motivation during this pandemic.
15767525|NCT04715893|Device|Ostomy belt|Stealth ostomy belt continuous for eight weeks
15767526|NCT04715880|Procedure|Paravertebral block/Intercostal Block (PVB/ICB) group|A paravertebral catheter will be placed by surgeon into pleural cavity and will not be loaded with bolus dose. At the end of surgery the (consultant anaesthesiologist) will perform intrathoracic unilateral intercostal nerve block two level above and two level below and at site of incision with 4 ml per level of 0.25 % bupivacaine followed by continuous infusion with 0.25 % bupivacaine at 6-8 ml/hour through catheter placed in paravertebral space.
15767527|NCT04715880|Procedure|Paravertebral Block (PVB) group|A paravertebral catheter will be placed by the surgeon before closure of thoracotomy wound. The catheter will be introduced percutaneously through 18 gauge needle into the pleural cavity. The tip of catheter will be loaded by anaesthesiologist with 0.25 % isobaric bupivacaine with 20 ml followed by continuous infusion with bupivacaine 0.25 % at 6-8 ml per hour
15767528|NCT04715867|Drug|Rabix-VC|Rabix-VC will be locally manufactured by Incepta Vaccine Ltd
15767529|NCT04715854|Device|Mask|addition of the mask above the nasal cannulas
15767530|NCT04715841|Other|gait assessment|gait assessment were done using 3DMA system
15767531|NCT04715828|Other|Cryopreserved semen|sperm will be frozen in Cryosperm® cryoprotectant medium (Origio). The samples will be packaged in previously identified high security straws (Cryobiosystem). Slow freezing of the straws will be carried out using the Nanodigicool® programmable device (Cryobiosystem).
15767532|NCT04715828|Other|Acute and low irradiation|sperm sample will be placed on the scanner's processing table to be exposed for 1 to 2 seconds. Several dose levels will then be made in order to limit the value of 17 mGy
15767533|NCT04715828|Other|Long and low irradiation|sperm sample will be exposed to gamma radiation by adding a solution of Tc99m for 3 hours.
15767534|NCT04715828|Other|Long and medium irradiation|sperm sample will be exposed to gamma radiation by adding a solution of I131 for 3 hours
15767535|NCT04715815|Other|No intervention (only interview)|Interview
15767536|NCT04715802|Procedure|Immediate breast reconstruction with implant|Because most fillers are under the mammary gland, it is better to place the prosthesis into the opening under the pectoralis major muscle, which avoids contact between the prosthesis and the residual hydrogel to reduce the chance of infection. If postoperative complications disappear and imaging shows no filler remnants after more than 3-month follow-up, secondary breast augmentation can be planned. For placement of the prosthesis, the plane under the pectoralis major is preferred, which avoids prosthesis contact with the residual hydrogel to thus reduce the chance of infection.
15767537|NCT04715802|Procedure|delayed breast reconstruction with implant|The first stage included maximal gel removal and purulent tissue debridement, if necessary. Thereafter, patients were invited for a clinical follow-up and discussion about DBR 3 months later. The latter was offered as a second stage in those opting for it.
15767538|NCT04715802|Procedure|delayed breast reconstruction with autologous fat transplantation|Because fat injection after PAAG removal has a high infection risk, it is recommended to be conducted after 3-6 months of follow-up. The advantage of autologous fat transplantation is its ability to repair a variety of breast shape deformities caused by PAAG removal. Fat injections may need to be repeated several times. The interval between injections should be at least 3 months. Usually, the amount of transplanted fat is 150-200 mL/side. A multilayer and multi-tunnel injection method is commonly used.
15767539|NCT04715789|Behavioral|graded exposure and activity|"Graded exposure: This approach followed a model where the patient was gradually exposed to previously pain provocative, feared and or avoided tasks. These activities are started at a diminished level that elicits minimal amounts of fear and then gradually increased to situations that elicit larger amounts of fear patients are asked to create a hierarchy of feared activities. The exposure starts with the least feared activity, and the therapist helps the patient appraise the exposure and its consequences and then address irrational and counterproductive beliefs, leading to reductions in the anxiety associated with the activity
~Graded activity exercises: The new postural and movement behaviors were integrated into each person's nominated pain provocative functional activities linked to their goals in order to generalize learning and build self-efficacy the program focuses on functional activities and progresses in a time contingent manner"
15767540|NCT04715776|Dietary Supplement|Brown seaweed|Uptake of 1650 mg brown seaweed product twice daily
15767545|NCT04715737|Drug|Vasopressin|Administration of vasopressin (20IU) intranasally
15767546|NCT04715737|Drug|Oxytocin|Administration of oxytocin (24IU) intranasally
15767547|NCT04715737|Drug|Placebo|Administration of placebo intranasally
15767548|NCT04715724|Other|Positioning and Attachment video-based simulation (telesimulation)|Participants will teach a standardized patient actor (SP) to position and attach the baby doll at the breast of the Lactation Simulation Model in a video-based simulation (telesimulation)
15767549|NCT04715711|Other|Forearm coolng|forearm immersion will be performed for active cooling assessment
15767550|NCT04715711|Other|Wet-towel cooling|Wet towels will be wrapped around the participant's arms for active cooling
15767551|NCT04715711|Other|mist-fan|a mist-fan will be placed in front of the participant for active cooling
15767552|NCT04715711|Other|passive cooling|"participants will sit in a chair and passively cool (no active intervention)"
15767553|NCT04715698|Other|ICG-guided drug selection|anti-hypertensive drug selection based on patient's hemodynamic profiling and physician's experience
15767554|NCT04715698|Other|empirical drug selection|anti-hypertensive drug selection based on physician's experience only
15767555|NCT04715685|Behavioral|40 minute session|The 40 minute session will include all of the content contained in the 20 minute session, but will include a greater explanation of each of the mind and body skills, followed by in vivo practice of each skill with the nurse. Sessions will also include review of home practice for each group.
15767556|NCT04715685|Behavioral|20 minute session|For participants randomized to the 20 minute session, content will include pain education, followed by brief explanations of each of the mind and body skills, in vivo diaphragmatic breathing practice and demonstration of use of biofeedback card. Sessions will also include review of home practice for each group.
15767557|NCT04715685|Behavioral|home practice e-health|Participants will be provided and instructed on access to a migraine-specific interactive web portal, Migraine e-Health. This web-based tool actively guides participants in practicing evidence-based mind and body skills. Use of the Migraine -e-Health application for the high dose capitalizes on teaching participants mind and body skills while increasing accessibility due to implementation on mobile devices.
15767558|NCT04715685|Behavioral|home practice handout|Participants will be given a handout of commercially available free apps relevant to the mind body skills introduced.
15767559|NCT04715685|Behavioral|phone call|The dose of phone call will occur about 4 weeks following the face-to-face mind and body introduction session and will last approximately 5-10 minutes. The phone call will be used to promote adherence to home-practice and answer questions related to skill use/home practice completion.
15767560|NCT04715659|Diagnostic Test|Performance of step test (number of steps) for the assessment of exercise capacity|"The development of the step test will be designed according to the characteristics of other validated field tests - the walking tests (6-minute walk test and the incremental shuttle walking test) The step test will be performed on a 20 cm tall, single-step device with no handles. The criteria for stopping the test will be the same as described in standard operating procedures for the walking field tests, with the addition of the inability to follow the work rate for a period of 10 seconds.
~The main outcome of the test will be the highest number of steps and work rate achieved."
15767562|NCT04715633|Drug|PD-1 inhibitor plus VEGF inhibitors|Camrelizumab 200mg IV every 3 weeks; Apatinib 250mg QD day 1-14. Rescue chemotherapy: Oxaliplatin 130mg/m2 IV drip Q3W d1+Capecitabine 1000mg/m2 QD d1-d14 Rescue chemoradiotherapy: Long-course radiotherapy +Capecitabine 825mg/m2 QD d1-d14
15767563|NCT04715620|Drug|Niraparib|Niraparib 300mg/day (body weight ≥77Kg and baseline platelet count ≥150,000/µL) or 200mg/day (body weight <77Kg or baseline platelet count <150,000/µL)
15767564|NCT04715607|Diagnostic Test|Sequence of testing.|The participants will be tested in the following sequences of sampling technique: (1) nasopharyngeal swab, oropharyngeal swab, and salvia collection OR (2) oropharyngeal swab, salvia collection, and nasopharyngeal swab OR (3) salvia collection, nasopharyngeal swab, and oropharyngeal swab. Only the sequence is different in the different arm, while the sampling technique for each method is the same in all arms.
15767565|NCT04715594|Device|1st-generation drug-eluting stent|Implantation of 1st-generation drug-eluting stent
15767566|NCT04715594|Device|2nd-generation drug-eluting stents|Implantation of 2nd-generation drug-eluting stent
15767567|NCT04715581|Dietary Supplement|Preoperative nutritional optimization|"Indication for oral nutritional supplementation: Patients at risk of malnutrition (MNA-SF 8-11) or with malnutrition (MNA-SF 0-7).
~Protocol of nutritional optimization: Enteral nutritional powder (Ensure for patients without diabetes and Glucerna for patients with diabetes) twice a day. The target protein intake is 1.5-1.8 g/kg/d. Patients with iron deficient anemia (hemoglobin <130 g/L for men and <120 g/L for women) will be given oral iron therapy.
~The duration of nutritional optimization: Two weeks prior to the surgery to one day prior to the surgery."
15767568|NCT04715581|Other|Preoperative exercise training|"Exercise training includes aerobic exercise and respiratory training.
~A home-based aerobic exercise will be performed for at least 1-2 times per day. The respiratory training will be performed for at least 2-3 times per day. Every training should be last for 45 minutes to 1 hour. If the patient can not tolerate, the training time should be reduce to 30 minutes.
~Aerobic exercise includes jogging, walking or climbing stairs. Exercise intensity will be based on patients' tolerance. The goal of the training is to complete the training plan as far as possible.
~Respiratory training include thoracic breathing exercise and cough training."
15767569|NCT04715568|Drug|Losartan|50 mg tablets taken orally
15767570|NCT04715568|Drug|Placebo|Tablets taken orally
15767571|NCT04715555|Device|Electrocardiogram monitoring|Continuous monitoring using a wearable, single-lead electrocardiography (ECG) device affixed to the chest.
15767573|NCT04715555|Device|Photoplethysmogram monitoring|Photoplethysmogram monitoring using a wearable device on the wrist.
15767574|NCT04715555|Other|Feedback questionnaire|A questionnaire to collect feedback on participants' experiences of wearing the devices.
15767575|NCT04715542|Drug|Stibium metallicum praeparatum 6x|Stibium metallicum praeparatum 6x will be administered with subcutaneous injections 3 times a week at 1 ampoule at 1 mL during the chemotherapy and shall be continued during 6 weeks after the end of chemotherapy . The first injection will be administered on the day of the first dose of chemotherapy, before the injection of the first dose of chemotherapy.
15767576|NCT04715542|Drug|Placebo|Placebo will be administered with subcutaneous injections 3 times a week at 1 ampoule at 1 mL during the chemotherapy and shall be continued during 6 weeks after the end of chemotherapy . The first injection will be administered on the day of the first dose of chemotherapy, before the injection of the first dose of chemotherapy.
15767577|NCT04715529|Drug|FZJ-003|Subjects will receive FZJ-003 oral capsules in a dose escalation format.
15767578|NCT04715529|Drug|Placebo|Subjects will receive placebo oral capsules (matching FZJ-003) in a dose escalation format .
15767579|NCT04715516|Behavioral|alcohol brief intervention|Nested within the lifestyle health promotion provided in both conditions, participants randomised to the experimental condition will receive an alcohol brief intervention. The strong evidence-base for alcohol brief intervention, amplified by Co-Investigators' Smith and Bragge's (BehaviourWorks) approaches to applied behaviour change, has provided the framework for the development of the alcohol brief intervention used in this study. This intervention comprises personalised feedback on alcohol consumption levels, comparison to gender/age drinking norms, and information and behaviour-change content regarding alcohol consumption (i.e. negative-framed messaging around alcohol risks and harms, positive-framed messaging on the health benefits of reducing alcohol intake, alcohol harm reduction strategies).
15767580|NCT04715516|Behavioral|lifestyle health promotion|Lifestyle health promotion specific to physical activity and maintaining a healthy weight, developed to be relevant to women attending breast screening services, will be provided.
15767581|NCT04715503|Radiation|PET imaging, 18F-FDG|PET-MRI with 18F-FDG
15767582|NCT04715503|Radiation|PET imaging, 68Ga-DOTANOC|PET-CT with 68Ga-DOTANOC
15767583|NCT04715490|Other|The Multimedia Symptom Management Program Intervention|"The program is composed of two parts: 1) a face-to-face presentation about the contents of the program, and 2) structured telephone support. The first part of the program will be conducted in the cardiology outpatient department. Participants will be instructed to read a HF handbook.
~The second part of the program, structured telephone support, allowed the nurses to maintain contact with the participants in order to follow their progress. The participants will be scheduled to receive eight telephone coaching calls over a 3-month period."
15767584|NCT04715490|Other|Control group|The control group will be provided with the HF handbook at the beginning of the 3-month period, and also will be received usual care, which included medical consultations, and two telephone calls.
15767585|NCT04715477|Behavioral|Hospital Anxiety Depression Measure|Hospital Anxiety Depression Measure
15767586|NCT04715464|Other|review of surveillance cultures within the past year|"ASC results are reported as positive or negative based on the culture source. Antimicrobial susceptibility testing is performed but not reported; however, physicians may obtain susceptibility information for MDR GNB only if clinically indicated through the microbiology department.
~Nasal swab for MRSA
~Respiratory specimens
~i. Sputum for MRSA, VRE, and Multi Drug Resistant gram-negative Bacteria (MDR GNB) (if not intubated but with productive cough) ii. Endotracheal aspirate for MRSA, VRE, and MDR GNB (if intubated) c. Drainage from any wounds for MRSA, VRE, and MDR GNB d. Rectal/ perianal swab for VRE, and MDR GNB e. Urine for MRSA, VRE, and MDR GNB (from patients catheterized prior to admission only)"
15767587|NCT04715451|Other|Novel Swaddle|A novel swaddling method.
15767588|NCT04715438|Biological|mRNA-1273 SARS-CoV-2 vaccine from Moderna|All participants will receive two vaccinations against COVID-19 according to standard of care.
15767589|NCT04715425|Procedure|Thoracoscopic pulmonary vein isolation without additional lesion + left atrial appendage exclusion/amputation|Bilateral pulmonary vein isolation using radiofrequency energy
15767590|NCT04715425|Procedure|Catheter pulmonary vein isolation without additional lesions|Bilateral pulmonary vein isolation using radiofrequency energy
15767591|NCT04715412|Other|patient counseling and adherence support|"Technical interventions include; identification of possible reasons for non-adherence, adherence support by developing simplified schedules for taking medications that were customized to individualized patient's lifestyle. Reminders for dose as well as tools/strategies the RTR may use to follow the dosing schedules if needed as pillbox were provided as needed
~Clinical pharmacists' guided patient training was individualized, repetitive, covered 6 months, and included more aspects and provided practical hints and strategies for medication management.
~Initial clinical pharmacist face-to-face session will be up to 60-minute then 30-minute follow-up sessions will be conducted monthly for 6 months during the scheduled post-transplant clinic visits as coordinated with the transplant physician to allow for single office visits for transplant related issues and comorbidities."
15767592|NCT04715399|Other|No intervention|No intervention
15767593|NCT04715386|Drug|StrataXRT|Patients will be asked to start topical application of their allocated topical preparation on the area of skin that will be irradiated at the onset of radiation therapy, every day until skin symptoms subside (see patient information pamphlet). Apply twice per day and can be reapplied as skin symptoms arise or as needed. The amount of StrataXRT provided to each patient will be recorded throughout treatment.
15767594|NCT04715373|Procedure|LISA|LISA administered in the DR after initial resuscitation or in the NICU after stepwise escalation of CPAP based on FiO2 ≥0.3. While maintaining infant on CPAP with binasal prongs/small nasal mask, a thin catheter (Hobart method) is inserted below the vocal cord using direct laryngoscopy. Poractant alfa (200mg/kg) is administered slowly over 2-3 minutes. Catheter is then withdrawn and infant is maintained on CPAP
15767595|NCT04715360|Combination Product|autologous activated platelet-rich plasma|Patient received standard medication for COVID-19 management and autologous activated platelet-rich plasma on day 1, 3 and 5 while patient in ICU. On day 0, 4 and 6, hematology analysis, multicytokines measurement and thorax X-ray were done to each patient
15767596|NCT04715360|Drug|Avigan|Patient received avigan 2x1,600 mg for a day, followed by 2x600 mg for five consecutive days.
15767749|NCT04714099|Drug|Placebo|Placebo
15767597|NCT04715334|Device|Mollii suit|The Mollii suit is a new technology of electrical stimulation in the form of whole-body garment with multiple electrodes individually programmed to stimulate the selected muscles. Based on preliminary studies, it is suggested that the Mollii suit improves spasticity. Recent studies also proposed that it improves mobility, gait, function and quality of life. However, these studies are based on qualitative and subjective measures.
15767598|NCT04715321|Other|CT perfusion examination|CT perfusion was performed with a 64-section multidetector CT scanner. The following CT parameters were used to acquire dynamic data: blood flow (BF), blood volume (BV), mean transit time (MTT), permeability-surface area product (PS), hepatic artery ejection fraction (HAF), hepatic artery perfusion (HAP), and hepatic portal vein perfusion (PVP). And we used these parameters to predict the vascular pattern.
15767599|NCT04715308|Procedure|Urinary diversion|The formation of a stoma to divert urine to the skin because of the need to resect the bladder as part of surgery for advanced pelvic malignancy
15767600|NCT04715295|Drug|Doxycycline Tablets|Doxycycline 200 mg daily for 7 days
15767601|NCT04715295|Drug|Rivaroxaban 15Mg Tab|Rivaroxaban 15 mg tablets daily from day 1 to day 10
15767602|NCT04715295|Combination Product|Hydroxychloroquine and Azithromycin|Hydroxychloroquine 400mg daily from day 1 to day 5 in combination with Azithromycin 500mg on day 1 and 250 mg daily from day 2 to day 5
15767603|NCT04715282|Procedure|Epley maneuver|Epley maneuver
15767604|NCT04715269|Drug|Alprazolam|Alprazolam 0.5 mg will be given when the patient with acute coronary syndrome would present to the emergency
15767605|NCT04715269|Other|Placebo|Empty capsule
15767606|NCT04715256|Behavioral|Cognitive assessment of obsessive-compulsive and impulsive behaviours|The content of the assessment will be the same for all subjects and will consist of a cognitive assessment (attention, impulsivity) and a clinical assessment (impulsive behaviour, autistic traits,obsessive-compulsive behaviour).
15767607|NCT04715256|Genetic|Genomic analysis|A genome-wide association study (GWAS) will be performed for all subjects to search for associations between KCNQ1 mutations, insulin regulation and psychological features.
15767608|NCT04715256|Diagnostic Test|Glucoregulation assessment|Fasted glycaemia and insulinaemia, glycated haemoglobin (HbA1c) and glycaemia following an oral glucose challenge test will be measured in all study subjects.
15767609|NCT04715243|Device|High flow nasal cannula (HFNC)|High flow nasal cannula as a form of non-invasive oxygen delivery
15767610|NCT04715243|Device|Helmet NIV|NIV interface
15767611|NCT04715243|Device|Face-mask NIV|NIV interface
15767615|NCT04715217|Biological|CD19-CD22 CAR-T cells|A autologous doping CAR - T cells injection targets with CD19 and CD22，fluorine dara marina injection(30 mg/m2，QD×3d) and cyclophosphamide injection (300 mg/m2，QD×3d)will be used to remove the lymphocyte before infusion CD19-CD22 CAR-T cells .
15767616|NCT04715204|Other|High Energy Oral Nutrition Supplement|Oral Nutrition Supplement (ONS) or enteral formula is a formula intended to treat individuals who are unable to meet their nutritional requirements through oral diet alone. European Food Safety Authority described ONS as a formula with caloric density >0.9 kcal/mL. Formula with caloric density of >1.2 kcal/mL is categorized as high energy ONS. This intervention has caloric density of 1.5 kcal/mL.
15767617|NCT04715204|Other|Standard Energy Oral Nutrition Supplement|Oral Nutrition Supplement (ONS) or enteral formula is a formula intended to treat individuals who are unable to meet their nutritional requirements through oral diet alone. European Food Safety Authority described ONS as a formula with caloric density >0.9 kcal/mL. This intervention has caloric density of 1 kcal/mL and it is categorized as standard energy ONS.
15767618|NCT04715204|Other|Formula-75/Formula-100|"Formula-75/Formula-100 is a special therapeutic foods to treat children with severe acute malnutrition. WHO designed F75 as a starter formula for stabilization phase with 75 kcal/100 mL, then it is continued with F100 for rehabilitation phase with 100 kcal/100 mL Formula-75 and Formula-100 are made according to recipe from WHO. The ingredients are skimmed milk powder, coconut oil, and sugar. Mineral mix is added, i.e. 2 ml every 100 ml of formula.
~The composition of F-75:
~Skimmed milk 25 g, coconut oil 100 g, sugar 30 g, mineral mix 20 ml, add water to 1000 ml
~The composition of F-100:
~Skimmed milk 80 g, coconut oil 50 g, sugar 60 g, mineral mix 20 ml, add water to 1000 ml"
15767619|NCT04715191|Genetic|CARE T cells|"Three different dosing schedules will be evaluated. The following dose levels will be evaluated:
~DL1: 1x10^8/m2 DL2: 3x10^8/m2 DL3: 1x10^9/m2
~The doses are calculated according to the actual number of GPC3-CAR transduced T cells."
15767620|NCT04715191|Drug|Cytoxan|Cyclophosphamide will be given at a dose of 500 mg/m2/day for 3 days given intravenously.
15767621|NCT04715191|Drug|Fludara|Fludarabine will be given at a dose of 30 mg/m2/day for 3 days given intravenously.
15767622|NCT04715178|Other|No intervention- registry only|No intervention- registry only
15767623|NCT04715165|Drug|USG-STAP with bupivacaine and dexmedetomidine|Patients will receive USG-STAP block with bupivacaine and dexmedetomidine in both sides ten minutes before skin incision and intraperitoneal normal saline
15767624|NCT04715165|Drug|IP bupivacaine and dexmedetomidine|Patients will receive bupivacaine and dexmedetomidine through the intraperitoneal route and USG-STAP block with normal saline at the end of surgery
15767625|NCT04715152|Drug|ACB with levobupivacaine and dexamethasone|Patients will receive ultrasound-guided (USG) ACB with levobupivacaine and dexamethasone 30 minutes before spinal anesthesia and sham intra-articular normal saline
15767626|NCT04715152|Drug|IA analgesia with levobupivacaine and dexamethasone|Patients will receive intra-articular levobupivacaine and dexamethasone at the end of surgery and sham USG-ACB with normal saline
15767627|NCT04715139|Device|Arthrex ProStop Implant|The ProStop® arthroereisis subtalar implant is intended to assist in treating the hyperpronated foot by stabilizing the subtalar join
15767630|NCT04715113|Other|Normobaric hypoxia (FiO2 15%)|"Inhalation of deoxygenated air through an altitude simulator (Altitrainer), for approx. 1/2 hour given by a facemask, first at rest and then during exercise."
15767631|NCT04715113|Other|Placebo-ambient air (FiO2 21%)|"Inhalation of room air through an altitude simulator (Altitrainer), for approx. 1/2 hour given by a facemask, first at rest and then during exercise."
15767632|NCT04715113|Other|Normobaric hypoxia (FiO2 15%) under Sildenafil|"Inhalation of deoxygenated air through an altitude simulator (Altitrainer), for approx. 1/2 hour given by a facemask, first at rest and then during exercise under Sildenafil."
15767633|NCT04715113|Other|Placebo-ambient air (FiO2 21%) under Sildenafil|"Inhalation of room air through an altitude simulator (Altitrainer), for approx. 1/2 hour given by a facemask, first at rest and then during exercise under Sildenafil."
15767634|NCT04715100|Other|Observational group|The study dependent variables will be: pain (vas scale), joint status (Hemophilia Joint Health Score), perception of quality of life (SF-36 questionnaire), list of roles (Oakley questionnaire), performance of basic activities of daily life (Barthel index) and the performance of instrumental activities of daily living (Lawton and Brody scale).
15767635|NCT04715087|Other|Blood sample (Day -42 to Day -28, Day 3),Skin swab sampling (Day -42 to Day -28, Day 0, Day 13) , patch test application (Day 0) , skin biopsies (Day 13)|A 50 mL blood sample will be collected in Lithium Heparin tubes (45 mL) and dry tube (5 mL), by venipuncture, at screening and Day 3. Bacteriological samples from AD patients will be performed by swabbing the skin at screening visit (Day -42 to Day -28). Each sample will be cultured in a RPMI/human serum AB medium and methi.R (methicillin Resistant) strains will be eliminated. Thus, only S. aureus methi.S (methicillin Sensitive) will be isolated to be re-applied (via patchtest) to AD patient. A well-characterized S. epidermidis lab strain will be also applied to AD patients. Patch tests containing S. aureus, S. epidermidis or a mix S. aureus/S. epidermidis will be applied on healed or improved area as defined by a lesional score ≤ 1 or a 2-point change from the baseline lesional score. Patch tests will be applied 48h and reading of the patch tests results and biopsies will be performed 72h after patch test application.
15767636|NCT04715087|Other|Blood sample (Day 0 ,Day 3),Skin swab sampling (Day 0,Day 13), patch test application (Day 1), skin biopsies (Day 13)|"A 50 mL blood sample will be collected in Lithium Heparin tubes (45 mL) and dry tube (5 mL), by venipuncture, at Day 0 and Day 3.
~Each bacteriological sample from AD patients performed by swabbing the skin at screening visit will be cultured in a RPMI/human serum AB medium and methi.R (methicillin Resistant) strains will be eliminated. Thus, only S. aureus methi.S (methicillin Sensitive) will be isolated to be applied (via patchtest) to a paired (age/sex) healthy volunteer. A well-characterized S. epidermidis lab strain will be also applied to healthy volunteers. Patch tests containing S. aureus, S. epidermidis or a mix S. aureus/S. epidermidis will be applied on healthy skin. Patch tests will be applied 48h and reading of the patch tests results and biopsies will be performed 72h after patch test application"
15767637|NCT04715074|Behavioral|Interviews|We will understand the impact psychosocial, lifestyle, and familial aspects play on an EOCRC diagnosis through 20 one-hour interviews with EOCRC patients and survivors.
15767638|NCT04715074|Behavioral|Pilot|Utilizing the Behaviour Change Wheel in conjunction with results gathered from Aims 1 and 2 we will develop a theory-driven, multi-media campaign intervention to increase awareness of EOCRC, risk factors, and early detection benefit.
15767639|NCT04715061|Other|Resting state (Control)|Participants were asking to sit on a sofa for 50 minutes.
15767640|NCT04715061|Other|Moderate Intensity Continuous Exercise (MICE)|MICE condition consisted of 50 minutes of moderate and continuous aerobic exercise on ergocycle. This includes a warm-up and cool-down period at low intensity, and a 40-minute period at moderate intensity (power output is equivalent to an effort perception from 4 to 6/10 and lactate levels from 2 to 4 mmol/L, obtained by submaximal test)
15767641|NCT04715061|Other|High Intensity Interval Exercise (HIIE)|HIIT condition consisted of a 30 minutes of aerobic exercise training perform on ergocycle. This includes a warm-up at low intensity, followed by 10 blocks of 1 minute at high intensity (power output corresponding to the highest power reached at the submaximal test and lactate levels > 4 mmol/L) and 1 minute of active cooldown (effort perception around 1-2/10).
15767642|NCT04715048|Drug|PrabotulinumtoxinA|Glabellar line correction
15767643|NCT04715048|Drug|Onabotulinum toxin A|Glabellar line correction
15767644|NCT04715035|Other|Physical therapy interventions|mobilization, stretch, education, eccentric exercises
15767645|NCT04715022|Drug|Ascorbic acid solution (American Regent Laboratories Inc.)|"Ascorbic acid solution (American Regent Laboratories Inc.) will be obtained from the KU Investigational Pharmacy located in the KU Clinical Research Center where studies will take place. A priming bolus of 0.06 g ascorbic acid/kg fat free mass (FFM) dissolved in 100 mL of saline will be infused intravenously at 5 mL/min for 20 minutes, followed immediately by a drip-infusion of 0.02 g/kg FFM dissolved in 30 mL of saline administered over 2 hours at 0.5 mL/min."
15767646|NCT04715022|Drug|Saline|Placebo (saline) will be administered
15767647|NCT04714996|Drug|ES-481|"Treatment Period Week 1 - 25 mg qd, Week 2 - 25 mg bid, Week 3 - 50 mg bid, Week 4 - 75 mg bid.
~Step-down and Washout Period Day 1 - 125 mg, Day 2 - 100 mg, Day 3 - 75 mg, Day 4 - 50 mg, Day 5 - 50 mg, Day 6 - 25 mg, Day 7 - 25 mg, Days 8 to 14 - 0 mg"
15767648|NCT04714996|Drug|Placebo|Placebo on Week 1, Week 2, Week 3 and Week 4
15767649|NCT04714983|Biological|DNX-2440|DNX-2440 is a replication competent oncolytic adenovirus expressing human OX40 ligand.
15767650|NCT04714970|Device|iTBS|Intermittent theta burst stimulation (iTBS) on left dlPFC. 90% RMT, 50Hz within train and 5Hz train for 2 second and rest for 8 second. 600 train and 200 second in total.
15767651|NCT04714970|Device|Shame stimulation|TMS coil vertical to the brain surface, with same protocol as iTBS
15767652|NCT04714957|Other|construction of a database of genetic and epigenetic data on peritoneal carcinomatosis of colorectal or ovarian origin.|Construction of a core database of genetic and epigenetic markers, in order to identify predictive biomarkers and potentially actionable targets for controlling the spread of peritoneal carcinomatosis.
15767653|NCT04714944|Dietary Supplement|Placebo|Supplementation period 12 weeks
15767654|NCT04714944|Dietary Supplement|Whole fiber product|Supplementation period 12 weeks
15767750|NCT04714086|Drug|Avapritinib|Avapritinib will be administered orally (PO) at a dose of 200 mg daily (QD), continuously in 28-day cycles
15767751|NCT04714073|Drug|BI 706321|BI 706321
15767752|NCT04714073|Drug|Itraconazole|Itraconazole
15767655|NCT04714931|Diagnostic Test|Sentinel lymph node detection|Tracer (Indocyanine green or blue dye) will be injected into the IP and utero-ovarian ligaments, after opening of the pelvic and paraaortic retroperitoneal spaces, sentinel lymph nodes which can be identified with the tracer involvement will be removed. Then, systematic lymphadenectomy will be performed according to the routine practice.
15767656|NCT04714879|Other|Device: anodal tDCS|anodal current modulated by an oscillatory component including a fixed (0,75 Hz) versus individually adapted so-tDCS frequency with three different stimulation durations (5 min, 2 min, 30 sec)
15767657|NCT04714879|Other|Device: no stimulation|sham stimulation
15767658|NCT04714866|Behavioral|Cognitive behavioral therapy for ADHD|CBT is a time-limited and structured approach that influences change in thoughts, feelings and behavior, leading to symptom changes.
15767659|NCT04714840|Other|Exercise testing results|Tailored, home-delivered aerobic and strengthening intervention,exercise intolerance,Both groups of participants will be provided with the results of their exercise testing.
15767660|NCT04714840|Other|Individually tailored exercise program (INT)|Individuals randomized to receive an individually tailored exercise program will meet with an exercise specialist. Written instructions, videos of each strengthening exercise, a blue tooth enable heart rate monitor, all necessary exercise equipment, and an iPad pre-loaded with heart rate monitor software, exercise videos and ZOOM app (for video conferencing) will be provided. After returning home, the exercise specialist will supervise and provide guidance to the individual via the ZOOM app during the first 2 weeks (3 sessions per week). Supervision will slowly decrease to twice a week in weeks 3-4, once a week in weeks 5-8, every other week in weeks 9-16, and to one time midway between weeks 17-20. The exercise program will be adjusted depending on the individuals progress.
15767661|NCT04714840|Other|Generalized exercise recommendations (AC)|Individuals randomized to receive the generalized exercise recommendations will receive a copy of the Physical Activity Guidelines for Americans. At the baseline visit, a study staff will review these guidelines and answer questions about their exercise testing and encourage them to be physically active. The staff will contact them via telephone to complete a short questionnaire weekly during weeks 1-8 and monthly for weeks 9-20.
15767662|NCT04714827|Biological|CD19-CD22 CAR-T cells|A autologous doping CAR - T cells injection targets with CD19 and BCMA，fluorine dara marina injection(30 mg/m2，QD×3d) and cyclophosphamide injection (300 mg/m2，QD×3d)will be used to remove the lymphocyte before infusion CD19-BCMA CAR-T cells .
15767663|NCT04714801|Drug|adipose derived mesenchymal stromal cells|Intravenous infusion of cells
15767664|NCT04714801|Drug|Saline|Intravenous infusion of saline
15767665|NCT04714788|Device|RECAP_MyLife mobile app|"The intervention will be the use of a mobile application for collecting data from cohorts participants, envisioning to engage participants and collect continuous unbiased records. Participants in the intervention group will install the mobile application on their smartphones on the beginning of the trial and will be asked to self-report information on mood every day. Simultaneously, physical activity (number of steps) will be passively tracked through real-time information.
~Participants will complete baseline and post-intervention measures of mood status based on the Circumplex Mood Model and IPAQ-Short form. Following these measures, participants will be asked to complete questionnaires on usability (SUS scale) and acceptability of the intervention."
15767666|NCT04714788|Other|Usual data collection methods|Participants in this group will provide data through usual types of data collection methods (face-to-face assessments, mailed questionnaires, online questionnaires).
15767667|NCT04714762|Device|eMOM GDM application|"Participants in the intervention group will use the eMOM GDM -application one week/month.
~eMOM GDM application includes:
~continuous glucose monitor (CGM, Medtronic)
~diet (speech-enabled food tracker) (min 3 days during one application week)
~heartrate, stress and physical activity with the wrist-worn activity tracker (Vivosmart 3)
~weight measured once a week
~The sensors can be worn and the application used during the whole pregnancy (if a mother is interested in)"
15767668|NCT04714749|Procedure|Endovenous treatment|Treatment of great saphenous vein (its tributaries and possible incompetent perforators feeding the ulcer) by endovascular cyanoacrylate glue
15767669|NCT04714749|Device|Cyanoacrylate glue|Treatment of great saphenous vein (its tributaries and possible incompetent perforators feeding the ulcer) by endovascular cyanoacrylate glue
15767670|NCT04714736|Device|Coronary angiography using DyeVert system|Invasive diagnostic and/or interventional cardiovascular procedures in the setting of acute coronary syndrome using DyeVert system.
15767671|NCT04714736|Procedure|Coronary angiography using conventional manual injection syringe.|Invasive diagnostic and/or interventional cardiovascular procedures in the setting of acute coronary syndrome using conventional manual injection syringe.
15767672|NCT04714723|Behavioral|Routine education|Routine lifestyle education based on smartphone for six month
15767673|NCT04714723|Behavioral|Programmed smartphone intervention|Interactive programmed lifestyle education based on smartphone for six month
15767674|NCT04714723|Behavioral|Programmed smartphone plus dietitian intervention|Interactive programmed lifestyle education based on smartphone plus dietitians support for six month
15767675|NCT04714710|Drug|IV Potassium Canrenoate|"Administration of 200 mg of IV potassium canrenoate (diluted in sodium chloride 0.9%) in brain-dead donors at 3-6 hours after the diagnosis of brain death and before the departure to the operating room.
~Second administration of potassium canrenoate 6 hours after first administration if the patient is not YET admitted IN the operating room"
15767676|NCT04714710|Drug|IV Sodium Chloride 0.9 %|"Administration of IV sodium chloride 0.9% (placebo) in brain-dead donors at 3-6 hours after the diagnosis of brain death is made and before the departure to the operating room.
~Second administration of IV sodium chloride 0.9% (placebo) 6 hours after first administration if the patient is not YET admitted IN the operating room."
15767677|NCT04714697|Drug|Cabometyx|Cabometyx 60mg once daily, oral , up to Progression disease
15767678|NCT04714684|Device|Fitostimoline proctogel|Medical device for topical use for the treatment of fissures
15767679|NCT04714684|Device|Fitostimoline proctogel + muscle relaxant|medical device for topical use for the treatment of fissures
15767753|NCT04714060|Biological|UB-621|mAb by SC administration
15767780|NCT04713891|Drug|KF-0210 tablets, 450 mg|KF-0210 tablet will be orally administered as a single agent at 450 mg once daily (QD) continuously, until the disease progression, intolerance, or informed consent withdrawal.
15767680|NCT04714671|Other|The virtual version of the Social stress task : V-TSST|The task consists in a brief presentation about the abilities of participants followed by an arithmetic task in front of a virtual 3D audience projected and one researcher in a small room.First, participants have 5 minutes to prepare an exhibition about their qualities, their strengths and defects, and, why they identify with them. During this period virtual reality shows a closed curtain, and sounds from the audience can be heard. In the second phase, the curtain is raised and the participant must expose his speech during 5 minutes. Audience will remain attentive during 2 minutes, then audience will change to a restless attitude. The third phase consists of subtracting back a two-digit number from a four-digit number, as quickly as possible, starting again if participant makes a mistake. A debriefing of the test is scheduled at the end of the protocol, to remind patients of the purely fictional nature of this test. The visit will only end after a return to the baseline emotional state
15767681|NCT04714658|Other|Therapeutic Education|"Each patient will participate in 1 to 3 PTE sessions.
~st group collective workshop : allow the patient to better understand autoimmune
~nd workshop : fatigue and techniques that enable its best management.
~rd workshop : improving the management of the emotions generated by myasthenia. It allows patients to express their experiences of the disease in front of a group, to talk about their difficulties in their relationships and mobilize their resources to promote exchanges."
15767682|NCT04714645|Device|VR neglect training|Patients will undergo 1 session a day for 30 minutes for 5 consecutive days. The training consists of 5 different VR tasks specifically designed for neglect training.
15767683|NCT04714645|Device|VR control training|Patients will undergo 1 session a day for 30 minutes for 5 consecutive days. This is a placebo training, where patients will also wear the HMD. Patients will be immersed in a virtual environment without a specific task.
15767685|NCT04714606|Other|Sibling support group|The intervention is a novel, 8 session sibling support group which has been created for the purpose of the study.
15767686|NCT04714606|Other|None - control condition|The second arm of the study is a control condition in which participants will be given a tailored booklet to complete at home as it was deemed unethical to provide them with nothing.
15767687|NCT04714593|Biological|CD19-CD22 CAR-T cells|A autologous doping CAR - T cells injection targets with CD19 and CD22，fluorine dara marina injection(30 mg/m2，QD×3d) and cyclophosphamide injection (300 mg/m2，QD×3d)will be used to remove the lymphocyte before infusion CD19-CD22 CAR-T cells .
15767688|NCT04714580|Other|Animal Fun Program|This program permits the operators to propose different activities, by following the needing of the children. As the name of this program suggests, all the activities involve an animal description, and ask the children to move like this animal, in a proper, correct and supervised way.
15767689|NCT04714554|Drug|Relugolix/E2/NETA FDC|Relugolix/E2/NETA (40 mg/1 mg/0.5 mg) FDC tablet; oral administration.
15767690|NCT04714554|Drug|Relugolix|Relugolix 120-mg tablets; oral administration.
15767691|NCT04714554|Drug|Erythromycin|Erythromycin 500-mg tablets; oral administration.
15767692|NCT04714541|Drug|Ketamine Hcl 50Mg/Ml Inj|Racemic Ketamine Will Be Infused At A Starting Dose of 0.75 mg/kg Over A Period of 45 Minutes. The Dose Will be Titrated, Based on Clinical Signs With Changes of 0.3mg/kg Up to Maximum of 0.95 mg/kg, and Lowest Dose of 0.3 mg/kg
15767693|NCT04714528|Other|Physical Exercise|Physical exercise as described before.
15767694|NCT04714528|Other|Relaxation Therapy|Relaxation therapy as described before.
15767695|NCT04714515|Drug|Montelukast|An FDA approved medicine to treat asthmatic patients
15767696|NCT04714515|Drug|Hydroxychloroquine|An FDA approved antiarthritis drug
15767697|NCT04714515|Drug|Ivermectin|An FDA approved anti-parasitic medicine
15767698|NCT04714489|Other|NO.|NO.
15767699|NCT04714476|Device|Made-to-measure compression garment|"Subjects will wear one of two made-to-measure compression garments:
~(1) JOBST® Confidence leggins (BT) and (2) JOBST® Confidence Bermuda (ET)"
15767700|NCT04714463|Procedure|Implant-based breast reconstruction|All types of implant based breast reconstructions
15767701|NCT04714463|Procedure|Autologous breast reconstruction|All types of autologous breast reconstructions
15767702|NCT04714463|Procedure|Combined methods|All types of breast reconstructions combining autologous and implant based techniques
15767703|NCT04714450|Behavioral|Experimental: MMST+|The format of the MMST will remain the same; however, the white noise, images and math task will be modified to mitigate habituation effects.
15767704|NCT04714437|Behavioral|F|The participant will be asked to chew the latex bag naturally.
15767705|NCT04714437|Behavioral|R|The participant will be asked to chew the latex bag unilaterally on the right-side.
15767706|NCT04714437|Behavioral|L|The participant will be asked to chew the latex bag unilaterally on the left-side.
15767707|NCT04714437|Behavioral|A1|The participant will be asked to chew the latex bag changing the side once.
15767708|NCT04714437|Behavioral|A3|The participant will be asked to chew the latex bag changing the side three times.
15767709|NCT04714437|Behavioral|A5|The participant will be asked to chew the latex bag changing the side five times.
15767710|NCT04714424|Device|Virtual Reality Headset|Virtual reality (VR) - a 3-D reality right in a headset
15767711|NCT04714411|Drug|Omadacycline|Omadacycline monotgherapy
15767712|NCT04714398|Behavioral|Opt-In Recruitment|Patients in the opt-in recruitment arm will receive a letter describing the program and inviting them to participate in the remote monitoring program. Along with the letter they will receive an informational brochure and a copy of the informed consent form. Patients in this arm will then receive a recruitment phone call explaining the program and consenting the participant verbally. If the participant consents to participate in the remote monitoring program, to receive text messaging, and to connection to care, the research coordinator will mail a blood pressure cuff and begin the remote monitoring program for the patient 6 days later.
15767713|NCT04714398|Behavioral|Opt-Out Recruitment|Patients assigned to opt-out recruitment will receive a blood pressure cuff with instructions in the mail along with a letter describing the program and opt-out framing regarding their participation, as well as a brochure and a copy of the informed consent form. Patients in this arm will receive a recruitment phone call similar to recruitment arm A, explaining the program and consenting the participant verbally. If the participant consents to participate in the remote monitoring program, to receive text messaging, and to connection to care, the research coordinator will begin the remote monitoring program for the patient immediately.
15767718|NCT04714359|Drug|MDMA|Three sessions of MDMA-assisted psychotherapy with flexible dose of MDMA from 80 to 120 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later
15767719|NCT04714346|Other|no interventions|there is no intervention
15767722|NCT04714307|Diagnostic Test|SCA3/MJD molecular diagnosis|Double-blind molecular diagnosis for determination of the presence of the mutation.
15767723|NCT04714307|Diagnostic Test|Cognitive Testing|"Cross-sectional Cognitive evaluation with
~CCAS Scale
~Trail-Making Test parts A and B
~Stroop Color-Word Test"
15767724|NCT04714307|Diagnostic Test|Psychiatric Evaluation|Cross-sectional Psychiatric evaluation with Hamilton-Anxiety and Hamilton-Depression rating scales.
15767725|NCT04714307|Diagnostic Test|Clinical Neurological Evaluation|Cross-sectional neurological evaluation with standardized clinical scales - SARA, SCAFI and CCFS.
15767726|NCT04714307|Diagnostic Test|Emotional Attribution Evaluation|Cross-sectional emotional attribution evaluation by means of the Reading the Mind in the Eyes Test (RMET).
15767727|NCT04714307|Diagnostic Test|Activities of Daily Living|Cross-sectional evaluation of Activities of Daily Living (ADLs) by means of Friedreich Ataxia Rating Scale Part II.
15767728|NCT04714294|Drug|HPP737 or placebo|HPP737 or placebo will be randomized to assign to subjects
15767729|NCT04714281|Device|Dialyser|Three consecutive treatment periods of four weeks, one last study week where the patient is re-assigned to the same type of dialyzer used before beginning the study and one follow-up week per patient. Each treatment period includes 12 hemodiafiltration HDF sessions and is assigned to one type of dialyzer: FX CorAL 600 Fresenius Medical Care, comparator FX CorDiax 600 Fresenius Medical Care and comparator xevonta Hi 15 (B. Braun).
15767730|NCT04714268|Procedure|Aorto-iliac endovascular procedure|Percutaneous procedure with stent placement
15767731|NCT04714255|Other|Trace Image and Coloring for Kids-Book (TICK-B)|A collection of images attractive that need to be colored, created as a book called TICK-B. This book was created with the instructions and recommendations of a pediatric psychiatrist and a professional drawing teacher at a children's school.Distraction with TICK-B began 1-3 min. before the intravenous cannula procedure and lasted until the end of the procedure.
15767732|NCT04714242|Drug|Ranibizumab Injection|Three monthly intravitreal injections of Ranibizumab
15767733|NCT04714229|Biological|Meningococcal(Groups A, C, W-135, and Y) Conjugate Vaccine|0.5mL single intramuscular dose on Day 0
15767734|NCT04714229|Biological|Meningococcal(Groups A, C, Y, and W-135) Conjugate Vaccine|0.5mL single intramuscular dose on Day 0
15767735|NCT04714216|Device|The Omnipod 5/Horizon HCL system|"The Omnipod 5/Horizon HCL system, consists of a disposable insulin infusion pump (or pod), a built-in model predictive control (MPC) insulin dosing algorithm, and a remote Personal Diabetes Manager (PDM) interface, that interact with a Dexcom G6 continuous glucose monitor (CGM) to automatically control insulin delivery based upon real-time glucose values. The PDM component also enables remote interaction with the system, including glucose monitoring as well as insulin dosing management and adjustments."
15767736|NCT04714203|Other|sarcopenia assessment|evaluation of sarcopenia status
15767737|NCT04714190|Drug|RC48-ADC|2.5 mg/kg IV every 2 weeks
15767738|NCT04714190|Drug|Paclitaxel injection|Administered according to label, as one option for Physician's Choice (determined before randomization)
15767739|NCT04714190|Drug|Irinotecan Hydrochloride Injection|Administered according to label, as one option for Physician's Choice (determined before randomization)
15767740|NCT04714190|Drug|Apatinib Mesylate Tablets|Administered according to label, as one option for Physician's Choice (determined before randomization)
15767741|NCT04714177|Drug|Edaravone Dexborneol|Edaravone Dexborneol 37.5 mg, containing Edaravone 30 mg and Dexborneol 7.5 mg, Edaravone Dexborneol 37.5 mg BID, 14 days, addition to standard of care of Intracerebral Hemorrhage
15767742|NCT04714177|Drug|Placebo|Edaravone Dexborneol matching injection, addition to standard of care of Intracerebral Hemorrhage
15767743|NCT04714164|Behavioral|Group Cognitive Behavioral Therapy|Therapy will be delivered weekly for 8 weeks by Zoom.
15767744|NCT04714151|Drug|K-877 ER 0.2 mg/day (once daily)|K-877 ER 0.2 mg tablet
15767745|NCT04714151|Drug|K-877 ER 0.4 mg/day (once daily)|K-877 ER 0.4 mg tablet
15767746|NCT04714151|Drug|K-877 IR 0.2 mg/day (twice daily)|K-877 IR 0.1 mg tablet
15767747|NCT04714112|Drug|dexamethasone|Intravenous administration of dexamethasone at different time for the duration of ISB with 0.5% ropivacaine
15767748|NCT04714099|Drug|Topical Cyclosporine A|In our study we used 0.05% CsA prepared in castor oil by transferring (20ml ) of sterile castor oil in a sterile glass vial under laminar flow, removing a volume (400ul)of oil with micropipette (sterile tips), and replacing this volume with an equal volume of alcoholic CsA solution [200mg cyclosporine in 8 ml ethanol (96%)] under laminar flow.
15767754|NCT04714047|Other|Progressive Resistance Training and no booster sessions|"An initial 12-week exercise intervention, consisting of 1-hour group sessions of progressive resistance training supervised by a physiotherapist 2 times per week.
~The sessions consist of a 10-minute submaximal warm up on an exercise bike followed by 50 minutes of PRT with exercises targeting the muscles of the hip and knee joints; leg press, hip extension, hip abduction, hip flexion and knee extension. The progression will be in line with guidelines provided by the American College of Sports Medicine. The intensity will follow repetition maximum (RM) targets, from 12 RM for the first week towards 8 RM for the last weeks.
~After the 12 weeks, this group consists of patients who are randomized to receive no further treatment. For the following 9 months, these patients are given a membership to a fitness center where they are encouraged to continue the same exercise regime."
15767755|NCT04714047|Other|Progressive Resistance Training and booster sessions|"An initial 12-week exercise intervention, consisting of 1-hour group sessions of progressive resistance training supervised by a physiotherapist 2 times per week.
~The sessions consist of a 10-minute submaximal warm up on an exercise bike followed by 50 minutes of PRT with exercises targeting the muscles of the hip and knee joints; leg press, hip extension, hip abduction, hip flexion and knee extension. The progression will be in line with guidelines provided by the American College of Sports Medicine. The intensity will follow repetition maximum (RM) targets, from 12 RM for the first week towards 8 RM for the last weeks.
~After the 12 weeks, this group consists of patients who are randomized to receive 4 booster sessions (at 1, 3, 5 and 7 months after termination of the initial 12 week intervention). Additionally, for the following 9 months, these patients are given a membership to a fitness center where they are encouraged to continue the same exercise regime without supervision."
15767756|NCT04714047|Other|Neuromuscular exercise and no booster sessions|"An initial 12-week exercise intervention, consisting of 1-hour group sessions of progressive resistance training supervised by a physiotherapist 2 times per week.
~The sessions consist of a 10-minute submaximal warm up on an exercise bike followed by 50 minutes of NEMEX training with exercises focused on stability, postural function, postural orientation, lower extremity muscle strength, and functional exercises. Progression is made when an exercise is performed with good sensorimotor control and good quality of the performance and with minimal exertion and adequate control of the movement.
~After the 12 weeks, this group consists of patients who are randomized to receive no further treatment. For the following 9 months, these patients are given equipment and encouraged to continue the same exercise regime at home without supervision."
15767757|NCT04714047|Other|Neuromuscular exercise and booster sessions|"An initial 12-week exercise intervention, consisting of 1-hour group sessions of progressive resistance training supervised by a physiotherapist 2 times per week.
~The sessions consist of a 10-minute submaximal warm up on an exercise bike followed by 50 minutes of NEMEX training with exercises focused on stability, postural function, postural orientation, lower extremity muscle strength, and functional exercises. Progression is made when an exercise is performed with good sensorimotor control and good quality of the performance and with minimal exertion and adequate control of the movement.
~After the 12 weeks, this group consists of patients who are randomized to receive 4 booster sessions (at 1, 3, 5 and 7 months after termination of the initial 12 week intervention). Additionally, for the following 9 months, these patients are given equipment and encouraged to continue the same exercise regime at home."
15767758|NCT04714034|Diagnostic Test|"to develop and validate a scale measuring online dating addiction (ODA) in sexual minorities - the ODA Scale"|"Qualitative part: scale development and validation with testing in 3 different participant samples, i.e. preliminary testing (n=10), pilot testing (n=30-60), validation (n=300).
~Quantitative part: longitudinal part conducted in the validation sample of the qualitative study part (n=300) with the aim to evaluate the association of ODA Scale scores with sexual health and mental health outcomes."
15767759|NCT04714021|Other|CO2|to insufflate CO2 into the stomach instead of air during the PEG
15767760|NCT04714021|Other|air|to insufflate air into the stomach instead of CO2 during the PEG
15767762|NCT04713982|Drug|Deutetrabenazine|Maximum dose of 48mg/day or up to 36 mg/d if receiving a strong CYP2D6 inhibitor
15767763|NCT04713969|Drug|Pantoprazole 40mg|Pantoprazole 40mg twice daily
15767764|NCT04713956|Drug|Granulocyte Colony-Stimulating Factor(G-CSF)|G-CSF was administered at 5 ug/kg/day on days-17 to -10. When white blood cell is more than 20G/L, stop using G-CSF.
15767765|NCT04713956|Drug|Decitabine (DAC)|Decitabine was administered at 20mg/m2/day on days -14 to -10.
15767766|NCT04713956|Drug|Busulfan (BU)|Busulfan was administered at 3.2 mg/kg/day on days -7 to -4 in G-CSF+DAC+BUCY group, and it was administered at 3.2 mg/kg/day on days -6 to -3 in G-CSF+DAC +BF group .
15767767|NCT04713956|Drug|Cyclophosphamide (CY)|Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
15767768|NCT04713956|Drug|Fludarabine (FLU)|Fludarabine was administered at 30 mg/m2/day on days -7 to -3.
15767769|NCT04713943|Dietary Supplement|>Your< Iron Syrup|Once daily dose of >Your< Iron Syrup in the amount of 1 mg/kg body weight of elemental iron for 12 weeks
15767770|NCT04713943|Other|Placebo|Once daily dose of placebo syrup for 12 weeks
15767771|NCT04713930|Drug|JNJ-61393215|JNJ-61393215 will be administered orally.
15767772|NCT04713930|Drug|Placebo|Placebo will be administered orally.
15767773|NCT04713917|Device|Hyaluronique Acid Gel|Vaginal gel based on HA with liposomal structure applicated 2 times a week
15767774|NCT04713917|Device|Laser CO2|The laser energy delivered along the vaginal wall heats the tissue without damaging it.
15767775|NCT04713917|Device|Hyaluronique Acid Injection|HA injection performed under the mucosae (2-3mm in depth) following one injection point every 5mm on the 3 first cm of the vagina and on the posterior part of the introitus.
15767776|NCT04713904|Drug|Clormadinone 2 mg and Ethinyl estradiol 0.02 mg Test Product Coated Tablets|Investigational Medicinal Product
15767777|NCT04713904|Drug|Clormadinone 2 mg and Ethinyl estradiol 0.02 mg Reference Product Coated Tablets|Evafem 20 (Trademark)
15767778|NCT04713891|Drug|KF-0210 tablets, 120 mg|KF-0210 tablet will be orally administered as a single agent at 120 mg once daily (QD) continuously, until the disease progression, intolerance, or informed consent withdrawal.
15767779|NCT04713891|Drug|KF-0210 tablets, 240 mg|KF-0210 tablet will be orally administered as a single agent at 240 mg once daily (QD) continuously, until the disease progression, intolerance, or informed consent withdrawal.
15767781|NCT04713891|Drug|KF-0210 tablets, 600 mg|KF-0210 tablet will be orally administered as a single agent at 600 mg once daily (QD) continuously, until the disease progression, intolerance, or informed consent withdrawal.
15767782|NCT04713891|Drug|KF-0210 (dosage RP2D-2) + Atezolizumab|KF-0210 tablet will be orally administered at dosage RP2D-2 once daily (QD) in combination with Atezolizumab that will be administered at 1200 mg every 3 weeks via intravenously infusion.
15767783|NCT04713891|Drug|KF-0210 (dosage RP2D-1) + Atezolizumab|KF-0210 tablet will be orally administered at dosage RP2D-1 once daily (QD) in combination with Atezolizumab that will be administered at 1200 mg every 3 weeks via intravenously infusion.
15767784|NCT04713891|Drug|KF-0210 (dosage RP2D) + Atezolizumab|KF-0210 tablet will be orally administered at dosage RP2D once daily (QD) in combination with Atezolizumab that will be administered at 1200 mg every 3 weeks via intravenously infusion.
15767785|NCT04713878|Other|Mesenchymal stem cells|Intravenous infusion of Mesenchymal stem cells
15767786|NCT04713865|Procedure|endovascular treatment|The bare metal stent covers the deep femoral artery lower than 50%
15767787|NCT04713865|Procedure|endovascular treatment|The bare metal stent covers the deep femoral artery in 50-90%
15767788|NCT04713865|Procedure|endovascular treatment|The bare metal stent totally covers the deep femoral artery
15767789|NCT04713839|Other|no intervention|We didn't have an intervention program, we used two questionnaires to evaluate participants.
15767792|NCT04713813|Other|Therapeutic exercise program via hippotherapy mechanical stimulator|Patients were planned to complete hippotherapy exercises sessions 3 times a week for 12 weeks, each lasting 35 minutes per sessions.
15767793|NCT04713813|Other|Therapeutic home exercise program|Patients were planned to complete home exercises sessions 3 times a week for 12 weeks, each lasting 35 minutes per sessions.
15767794|NCT04713800|Device|Monolithic zirconia screw retained implant-supported cantilever reconstruction supported by titanium base abutments, in a full digital workflow (ZR-TiB)|In group ZR-TiB the implant impressions will be taken using an intra-oral scanner and the respective scanbody. The restorations will be manufactured by means of CAD/CAM procedures using monolithic zirconia. For sufficient aesthetics, the zirconia restorations can be manually veneered with veneering ceramic only at the buccal surface, while the occlusal surface will remain monolithic and will be high-gloss polished. The zirconia restorations will be extra-orally cemented onto titanium base abutments (Straumann® Variobase® for crown, Straumann AG), correctly polished and delivered to the patient, by screw-retention onto the implant.
15767795|NCT04713800|Device|porcelain fused-to metal screw retained implant-supported cantilever reconstruction supported by a gold-abutment, in a conventional workflow (PFM-GA)|In group PFM-GA implant impression will be taken using a polyvinyl siloxane or polyether impression material in a conventional manner with the use of stock trays and corresponding impression copings. The framework will be manufactured by the lost wax-technique using a gold-abutment (Straumann® Gold abutment for crown, Straumann AG) and a gold-alloy. All metal frameworks will be manually veneered with veneering ceramic, polished and glazed, and delivered to the patient, by screw-retention onto the implant.
15767796|NCT04713787|Drug|Albendazole|Albendazole, 5-(prophylthio)-2-benzimidazole carbamate, is a broad-spectrum benzimidazole antihelminthic drug. It is provided as a white to off-white, circular, film-coated tablet with a slightly raised pentagonal projection on either side. This trial will use the 400 mg tablet formulation.
15767797|NCT04713787|Drug|Oxfendazole|The active pharmaceutical ingredient is methyl-5 (6)-phenylsulfiyl-2-benzimidazole carbamate, which is a broad-spectrum benzimidazole antihelminthic. Oxfendazole is the sulphoxide metabolite of fenbendazole.
15767798|NCT04713774|Device|High-resolution peripheral quantitative CT scanner (HRpQCT)|HR-pQCT images of the distal radius and distal tibia (non-dominant, non-fractured limb) will be obtained using the XtremeCT device with standard protocols. HR-pQCT images wil be analysed with standard software and extended cortical measures software. This software identifies the periosteal and endosteal boundaries, enabling assessment of cortical micro- structural bone properties, including apparent cortical thickness (Ct.Th, mm), cortical tissue mineral density (TMD, mgHA/cm3) and cortical porosity (Ct.Po, %).
15767799|NCT04713761|Drug|Toripalimab|"Neoadjuvant treatment stage: Toripalimab 240mg, Carboplatin AUC5+ pemetrexed 500 mg/m ², iv, 3 weeks per cycle, 2-4 cycles in total; Surgical treatment stage: Patients with MPM received surgical treatment (PD/EPP) after neoadjuvant therapy. Patients who were unable to operate or refused surgical treatment due to various reasons were treated with multidisciplinary discussion.
~Adjuvant treatment stage: CR, PR and SD patients who have been treated surgically: Toripalimab 240mg, Carboplatin AUC5+ pemetrexed 500 mg/m ²,iv, up to 4 cycles (including neoadjuvant stage)."
15767800|NCT04713748|Device|Tasso-SST on Demand|Participants will collect a small blood sample using the Tasso-SST OnDemand device during a serology blood draw visit already scheduled for the MURDOCK C3PI Study (Pro00105703). Participants will be provided a kit that includes written, step-by-step instructions that include pictures. Participants will also have the option to watch a brief video on using the device, available online, prior to collection. Both blood samples will be spun and processed for serum. Serum will be frozen and shipped to the lab at Duke for antibody testing. Antibody results will be compared between the two methods.
15767801|NCT04713748|Other|Regular Phlebotomy|Participants will have a small blood sample collected via regular venipuncture.
15767802|NCT04713735|Dietary Supplement|Control: Placebo|Placebo
15767803|NCT04713735|Dietary Supplement|bovine lactoferrin supplement|600 mg
15767804|NCT04713709|Combination Product|Nasus Pharma FMXIN001|A nasal spray of 4mg Naloxone Hydrochloride powder in a unit dose device
15767805|NCT04713709|Combination Product|Nasal Naloxone liquid spray|A nasal spray of 4mg/0.1mL Naloxone Hydrochloride solution in a unit dose device
15767806|NCT04713696|Other|Functional training|Functional training refers to exercises that targets the muscles of the lumbopelvic-hip complex in order for them to more appropriately support and control the spine.
15767807|NCT04713696|Other|Routine training|Routine training refers to general exercises that perform before and after practice, including jogging, stretching and strengthening exercises for upper and lower extremities
15767833|NCT04713592|Drug|Risankizumab|Subcutaneous (SC) Injection
15767834|NCT04713592|Drug|Placebo for Risankizumab|Subcutaneous (SC) Injection
15767808|NCT04713683|Device|Percutaneous Patent Foramen Ovale Closure|Patients with well-documented embolic stroke of unknown source (ESUS) and a patent foramen ovale (PFO) are indicated for percutaneous closure of PFO. The intervention is performed through the right femoral vein. The interventional cardiologist introduces the sheath and advances the device via inferior vena cava to right atrium. Then, the catheter is passed through the PFO, the device is deployed and the occlusion is achieved. The procedure is performed under fluoroscopy guidance with or without transesophageal echocardiography guidance.
15767809|NCT04713670|Drug|(A) T-V14|vonoprazan(vocinti)-based triple therapy for 14 days (T-V14)
15767810|NCT04713670|Drug|(B) T-V7|vonoprazan(vocinti)-based triple therapy for 7 days (T-V7)
15767811|NCT04713670|Drug|(C) D-V14|vonoprazan(vocinti)-based dual therapy for 14 days (D-V14)
15767812|NCT04713670|Drug|(D) HD-V14|vonoprazan(vocinti)-based high dose dual therapy for 14 days (HD-V14)
15767813|NCT04713670|Drug|(E) BQ-V14|vonoprazan(vocinti)-based bismuth quadruple therapy for 14 days (BQ-V14)
15767814|NCT04713670|Drug|(F) RH-V14|vonoprazan(vocinti)-based reverse hybrid therapy for 14 days (RH-V14)
15767815|NCT04713670|Drug|(G) BQ-L14|lansoprazole(takepron)-based bismuth quadruple therapy for 14 days (BQ-L14)
15767816|NCT04713670|Drug|(H) T-L14|lansoprazole(takepron)-based triple therapy for 14 days (T-L14)
15767817|NCT04713657|Other|N-thymidine|15N-thymidine will be administered to patients in order to quantify cardiomyocyte proliferation. 15N-thymidine will be administered as 5 separate syringes. Each syringe will contain the recommended daily dose based on participants weight. Subjects will be given the labeled thymidine by mouth once a day for 5 consecutive days. The dosing will begin one week after starting the study drug.The caregiver (parent or nurse) will administer the labeled thymidine by mouth via a syringe once a day for 5 consecutive days. They will be provided with a diary to keep track of study drug dosing.
15767818|NCT04713657|Other|Urine Collection|Parents will be asked to keep a diary of the child's feeding and diaper changes during the administration of thymidine. To monitor how the labeled thymidine is processed in the body, investigators will analyze urine from the child's diapers. Each time a diaper is changed, a cotton ball will be placed in the diaper. At the next diaper change, this cotton ball will be removed from the diaper, placed in a Ziploc bag, and stored in the freezer. They will be collected and stored cotton balls starting with the first administration of thymidine until 24 hours after the last administration. The frozen cotton balls may be collected from the home by a nurse or brought by parent to the next clinic visit.
15767819|NCT04713657|Procedure|Echocardiogram|On Study Day 1 to obtain baseline assessment of cardiac size. A second research dedicated echocardiogram will be done after being anesthetized for surgery. Echocardiography is routinely performed to determine right ventricle (RV) structure of the heart and function in ToF/PS and is non-invasive.
15767820|NCT04713657|Procedure|Cardiac MRI|"A limited study protocol will be performed using the feed-and-bundle technique at the time of study enrollment, The feed and bundle technique is utilized so that the infant will be as comfortable as possible and asleep during the procedure. This is done to prevent the risk of sedation and allow for a more natural sleep. The baby is undressed, prepared with ECG-leads and an oxygen saturation probe, and fed. With this feed, swaddle, and sleep technique, scanning times of 30-60 minutes can be achieved, which provides the stillness needed for accurate visualization of the heart. A second CMR, with the same limited study protocol, will be performed under general anesthesia prior to surgical repair. It does not pose any risk of radiation exposure and will not require IV placement or contrast administration for a limited assessement of the right ventricle."
15767821|NCT04713657|Drug|Propranolol Hydrochloride|For patients who are randomized to receive propranolol, The target dose for this study will be 4 mg/kg/day divided in 4 doses. The first dose will be given in the Pediatric Clinical and Translational Research Center (PCTRC) at 1mg/kg. Parents will administer propranolol (1 mg/kg po x 4 doses per day). Parents will be instructed to administer propranolol with feeding or soon after feeding, but not before feeding. families will also be given instructions for regarding 15N-thymidine dosing frequency and interval and provided with a log sheet to record administered and missed doses of propranolol and 15N-thymidine.
15767822|NCT04713657|Drug|Placebo|For patients who are randomized to receive placebo, the first dose will be given in the Pediatric Translational Research Center (PCTRC) and will be based on the patients weight. Parents will administer placebo 4 doses per day. Treatment with placebo will begin at 1 month of age and continue until surgical repair, which happens usually at 3 - 9 months of age.
15767823|NCT04713657|Procedure|Physical Exam|On Study Day 1; monthly until surgery in conjunction with patient's clinical cardiology appointment; and at the time of surgery. Will include vital signs.
15767824|NCT04713657|Other|Specimen Collection|On the morning of surgery, after IV access is obtained for anesthesia 2 ml of blood will be collected for analysis. A small piece of heart tissue and fat that has already been removed during surgery will be collected for analysis.
15767825|NCT04713644|Drug|Standardized Propofol Administration|Intravenous bolus propofol administration of 0.5 mg/Kg dose, plus 0.5 mg/Kg extra if necessary
15767826|NCT04713631|Drug|Artesunate|Artesunate is approved for the treatment of malaria and is on the World Health Organization list of Essential Medicines. Artesunate has a hemisuccinate group which confers substantial water-solubility and high oral bioavailability and therefore a convenient oral route of administration. Artesunate has a good safety and tolerability profile, having been used to treat millions of adults and children globally.
15767827|NCT04713631|Drug|Curcumin|Curcumin has been used in Indian cuisine and traditional medicine for centuries. It has low solubility in aqueous solution and yields low serum levels following oral administration. In the setting of inflammatory bowel disease where the required site of action is the bowel, systemic absorption may be less relevant. Curcumin and its reduced metabolites undergo conjugation in the liver. Curcumin has a half life of 6-7 hours. It has been found to be safe at oral doses of 2 gm and 3 gm a day in patients with ulcerative colitis, for up to 1 year. In a dose titration study conducted in children with inflammatory bowel disease 2 gm twice daily of curcumin was well tolerated
15767828|NCT04713631|Drug|Placebo A|Artesunate looking placebo
15767829|NCT04713631|Drug|Placebo C|Curcumin looking placebo
15767830|NCT04713618|Procedure|Pelvic Examination|Undergo pelvic exam
15767831|NCT04713618|Other|Survey|Complete surveys
15767832|NCT04713605|Device|Critical closing pressure detection|Observational study that determines the critical closing pressure (CrCP) of the brain by comparison of the cerebral blood flow velocity (measured by TCD) and invasive blood pressure measurement (IABP)
15767835|NCT04713579|Other|No intervention - observational study|There is no intervention in this study as it is purely observational.
15767836|NCT04713566|Other|oral rinces|natural and commercial oral rinses were compared for efficacy
15767837|NCT04713553|Biological|BNT162b2|Intramuscular injection
15767838|NCT04713553|Biological|BNT162b2.B.1.351|Intramuscular injection
15767839|NCT04713527|Diagnostic Test|Cultivation and PCR within 24 hours|During operation for appendicitis peritoneal fluid will be extracted. This is sent to cultivation and PCR analysis to determine if there is bacteria within the peritoneal cavity.
15767840|NCT04713527|Drug|Enteral antibiotics|Patients with complicated appendicitis will receive enteral antibiotics instead of intravenous
15767841|NCT04713514|Drug|OSE2101|subcutaneous injection on day 1, every 3 weeks for 7 doses then every 6 weeks up to week 48 and then every 12 weeks until intolerance, disease progression, or up to 2 years.
15767842|NCT04713514|Drug|Pembrolizumab 25 MG/ML [Keytruda]|400 mg IV infusion on day 1 every 6 weeks until intolerance, disease progression, or up to 2 years.
15767843|NCT04713501|Behavioral|PARTS Program|The PARTS Program is a 16-week group intervention model, with 8 individual clinical sessions on a biweekly basis, developed to resolve and alleviate trauma and stress for individuals diagnosed with PTSD.
15767844|NCT04713488|Biological|Sputnik Light|solution for intramuscular injection Composition for 1 dose (0.5 ml)
15767845|NCT04713475|Biological|PBGM01|AAVhu68 viral vector
15767849|NCT04713436|Drug|Differentiation Markers|Osteocalcin (BGLAP), dentin sialo phosphoprotein (DSPP) and alkaline phosphatase (ALPP) gene expression levels were also evaluated.
15767850|NCT04713423|Diagnostic Test|Diagnosis and treatment of the case|The infant was transferred to a hospital for better management of her infection. She was immediately started on intravenous acyclovir (20 mg/kg/6 h/5 d) while acetaminophen suppositories (80 mg/8 h/5 d) were given to lower her body temperature. In addition, other palliative drugs, such as diphenhydramine syrup (12.5 mg/5 mL, 2.5 mL orally) once-a-night for five days, were given to ease the effort of drinking and to aid in achieving good sleep. Upon completion of five days of therapy, the patient showed complete recovery and was subsequently discharged from the hospital free from symptoms.
15767851|NCT04713410|Drug|Prednisolone|Regimen will be to administer prednisolone as a single dose of 60 mg/m2 once daily for 6 weeks, then 40 mg/m2 on alternate day.
15767852|NCT04713397|Diagnostic Test|Leg Length Discrepancy Scoliometer Test|"A scoliometer used as an indirect and quantitative method to evaluate LLD for the first time in this study, and described it as Leg Length Discrepancy Scoliometer Test. Scoliometer were used on Adams' forward bending position and the level of the pelvis accepted as equal when the scoliometer degree pointed zero on the sacral basis (angle of trunk rotation on sacrum). When considering pelvis level is high on the longer side and is low on the shorter side, if the angle of the scoliometer on the sacrum is negative (slope to the left), the left extremity was considered as shorter. In order to determine its correlation with an indirect method, scoliometer degree on the sacral basis was recorded then wooden blocks were added to the unequal leg side on the sacral basis until the pelvic equality was achieved on the scoliometer. Afterward, a correlation between the first measurement of ATRsacrum and the height of the wooden block which provides ATRsacrum to reach zero was investigated."
15767853|NCT04713384|Device|Integrative tele-rehalitation of chronic stroke survivors using custom therapeutic games|20 sessions of playing therapeutic games using both arms while siting at a table at home. Arms hold either generic game controllers, or BrightBrainer therapeutic controllers. Sessions involve a variety of games that train motor and cognitive function in an integrative way. The games are rendered by the BrightBrainer system. Games adapt and are winnable, benefiting well-being (reducing depression). Each session may generate many hundreds of arm repetitions, finger movement and grasps, depending on session duration. Data on arm reach as well as game outcomes and vitals are uploaded to an secure server. These data allow researchers to remotely monitor compliance to protocol and longitudinal progress. Caregivers are present at each session, and provide feedback as well as subjective ratings of the system.
15767854|NCT04713371|Drug|Keytruda Injectable Product|"Keytruda (pembrolizumab): PD-1 inhibitor antibody
~Injectable 50mg/mL, only 2 mL injected."
15767855|NCT04713371|Drug|Yervoy Injectable Product|"Yervoy (ipilimumab): Anti-CTLA-4 antibody
~Injectable 5mg/mL, only 2 mL injected."
15767856|NCT04713371|Drug|Cytoxan|Injectable 250mg/m2, only 1 mL injected. Oral low dose cyclophosphamide: 50mg once daily pill for 5 days prior to first treatment, 3 days prior to 2nd and 3rd treatment.
15767857|NCT04713371|Procedure|Cryosurgical freezing (cryosurgery)|Cryosurgery, also known as cryoablation, for metastatic cancer works by freezing the cancer cells inside the tumor. Cryoablation will release intact antigens to prime the immune system.
15767858|NCT04713371|Drug|GM-CSF Injectable|Daily injection administered subcutaneously. 250 mcg daily injections for a total of 25 days post after each treatment.
15767859|NCT04713358|Drug|Nalmefene|Immediately Intravenous injection of Nalmefene (0.25 g/kg, plus normal saline to 1ml) after surgery
15767860|NCT04713358|Drug|normal Saline|Immediately Intravenous injection of normal saline 1ml after surgery
15767861|NCT04713345|Other|Virtual Reality Observations|If the patient is included in the Virtual Reality group, they will be asked to observe 1 time per day for 9 days for 5 minutes Virtual Motor Actions (avatar moving in a virtual environment) using a headset. Virtual Reality, followed by 5 minutes of relaxation performed using soothing music played through headphones.
15767862|NCT04713345|Other|Relaxation|If the patient is included in the Relaxation group, they will be offered 10 minutes of relaxation performed using soothing music played through headphones once a day for 9 days.
15767892|NCT04713124|Other|Self-help booklet|A booklet of information and self-help strategies for methamphetamine use problems.
15767893|NCT04713111|Behavioral|Lifestyle (Meditation)|Those in the meditation arm (exercisers) were instructed to complete meditation sessions from the smartphone app, Headspace 2 or more times a week for a duration of 4 weeks.
15767894|NCT04713111|Behavioral|Lifestyle (Exercise)|Those in the physical activity arm (meditators) were instructed to complete 30 minutes to 1 hour of physical activity for 2 or more sessions per week for 4 weeks.
15767863|NCT04713332|Dietary Supplement|Vitamin E|Members of the vitamin E family are hydrophobic fat-soluble compounds found in a variety of food sources such as vegetable oils, fruits, and vegetables consumed through diet. Vitamin E exists in 8 isoforms, a, b, g, d-tocopherol, and a, b, g, d-tocotrienol. The recommended daily allowance for adults is 15 mg per day for alpha-tocopherol, an amount which is easily met by dietary sources, and 30 mg per day for synthetic all-rac-alpha-tocopherol. The upper limit for intake is 1,000 mg per day. Very often, the dosage of vitamin E is given in international units (IU) as capsules, with a typical dose being 400 IU per day, which is above the recommended daily allowance. The health benefits of consuming vitamin E through diet or supplementation are believed to be for its antioxidant properties as a peroxyl radical scavenger. Vitamin E protects cells from cell damage caused by free radicals that damage cell membranes through lipid oxidation leading to DNA damage and cancer development.
15767864|NCT04713332|Dietary Supplement|Hydrogen rich water|Molecular hydrogen is a new medical gas that can be dissolved in water and administered through drinking, inhalation, baths, intravenous drip. A growing body of evidence indicates that hydrogen, as a novel antioxidant, scavenges hydroxyl radical and peroxynitrite. In contrast to other antioxidants, gaseous molecular hydrogen efficiently penetrates cytoplasmic membranes and targets intracellular organelles, largely owing to its small size and neutral electricity. Thus, hydrogen has been suggested as a suitable candidate for the therapeutic strategies for various diseases, including certain types of cancer. Hydrogen has emerged as a promising cancer remedy as a preventative agent or in combined therapy with anticancer drugs. Hydrogen water consumption might mitigate the side effects of anticancer drugs by decreasing oxidative stress and ameliorating metamorphosis due to decreased apoptosis.
15767865|NCT04713332|Dietary Supplement|placebo|Placebo containing gelatin is made by cooking down the protein collagen found in the skin, hooves, connective tissues, and bones of animals. The cooking process breaks down the bonds between proteins to make smaller, more bioavailable building blocks that your body can easily absorb. Like collagen, gelatin is packed with beneficial amino acids, especially the anti-aging superstar's glycine and proline, which are lacking in the standard Western diet. These amino acids make gelatin especially powerful for healing skin, gut, and joint damage. Because collagen and gelatin come from the same source, they have identical amino acid profiles
15767868|NCT04713280|Procedure|Maxillary posterior dento-alveolar intrusion|Mini-screw supported maxillary or bi-maxillary posterior dento-alveolar intrusion
15767869|NCT04713267|Device|ISABel Bed 1|During the intervention nights (2 out of 3 experiment nights), positional therapy by means of the automated bed will be applied in order to induce a change in the sleeping position.
15767870|NCT04713254|Drug|Lu AG06466|10, 20, 30 mg/day oral capsules on Day 5-18
15767871|NCT04713254|Other|Midazolam|4 mg syrup, oral single dose on Day 1 and Day 15
15767872|NCT04713254|Other|Metoprolol|100 mg tablets, oral single dose on Day 1 and Day 15
15767873|NCT04713254|Other|Bupropion|100 mg tablets, oral single dose on Day 3 and Day 17
15767874|NCT04713241|Procedure|Electro-acupuncture|"20-30 minute acupuncture treatment in sessions from start of study (within 48 hours of diagnosis) to return of bowel functions
~A practitioner stimulates certain points on the body by placing thin needles in the skin. Electrical stimulation is then added to some of the needles. This involves placing wires on the needles, which are connected to a machine that delivers a weak electrical current through the wires. The strength of the electrical current will be changed slowly until it is at a comfortable level."
15767875|NCT04713241|Other|Standard of Care Bowel rest|Bowel rest with NPO status and placement of nasogastric tube (NGT) if clinically indicated
15767876|NCT04713228|Device|ARTSENS Pen|ARTerial Stiffness Evaluation for Noninvasive Screening
15767877|NCT04713215|Other|Questionnaire|A short (approximately 20-minute) questionnaire will be administered to patients and carers who meet the inclusion criteria and who have expressed and interested, and consented to completing the questionnaire.
15767878|NCT04713202|Drug|Telotristat ethyl|Telotristat Ethyl, 250mg
15767879|NCT04713202|Drug|Peptide Receptor Radionuclide Therapy|Peptide Receptor Radionuclide Therapy
15767880|NCT04713202|Other|Placebo|Placebo
15767881|NCT04713189|Drug|Inhaled fentanyl aerosol|Participants in the stage I were randomized to 6 BTP episodes, in which 4 BTP episodes were treated with inhale fentanyl aerosol (with a starting dose of 25 µg every 4 minutes until adequate pain alleviation. The maximum doses are 6×25 µg) and 2 BTP episodes with placebo(0 µg every 4 minutes until adequate pain alleviation. The maximum doses are 6×0µg) in a random sequence.
15767882|NCT04713189|Drug|Placebo|Participants in the stage Ⅰ were randomized to 6 BTP episodes, in which 2 BTP episodes were treated with placebo (0 µg every 4 minutes until adequate pain alleviation. The maximum doses are 6×0µg) in a random sequence. I
15767883|NCT04713176|Drug|DWJ1248 with Remdesivir|PO, 1 tablet of DWJ1248 TID(up to 14 days) IV, Remdesivir(up to 5 or 10 days)
15767884|NCT04713176|Drug|Placebo with Remdesivir|PO, 1 tablet of placebo TID(up to 14 days) IV, Remdesivir(up to 5 or 10 days)
15767885|NCT04713163|Drug|covid19 vaccine|Vaccine
15767886|NCT04713150|Other|No Intervention|No Intervention
15767887|NCT04713137|Dietary Supplement|Erythritol|50g erythritol dissolved in 300mL tap water.
15767888|NCT04713137|Dietary Supplement|Sucrose|33.5g sucrose dissolved in 300mL tap water.
15767889|NCT04713137|Dietary Supplement|Sucralose|0.0558g sucralose dissolved in 300mL tap water.
15767890|NCT04713137|Dietary Supplement|Water|300mL tap water.
15767891|NCT04713124|Behavioral|R2C-M|R2C-M comprises 12 modules addressing core practice elements and skills from evidence-based cognitive and behavioural interventions. Modules include: (i) self-monitoring, goal setting and behaviour change skills; (ii) identification of strengths and motivational enhancement; (iii) relapse prevention; (iv) psychoeducation and harm reduction; (v) emotion regulation skills; (vi) anger management skills; (vii) urges and cravings management skills; (viii) sleep hygiene skills; (ix) mindfulness skills; (x) interpersonal skills; (xi) anxiety management skills; (xii) depressed mood management skills. The R2C-M workbooks contain psychoeducation and intervention exercises, to facilitate counsellor-delivered exercises within sessions, and between-session practice.
15767895|NCT04713098|Device|Peripheral Nerve Stimulation|ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that generates electric current for 14 days
15767896|NCT04713098|Device|Sham|SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that does not generate electric current for 14 days
15767897|NCT04713085|Device|Sacral Nerve Stimulation|Internal, implanted sacral nerve stimulation (electrodes in contact with neuronal fibers S3/4)
15767898|NCT04713085|Device|Non-invasive Sacral Nerve Stimulation|External, non-invasive sacral nerve stimulation via two adhesive electrodes (single current).
15767899|NCT04713072|Biological|ABY-035|ABY-035 solution for injection
15767900|NCT04713072|Biological|Placebo|Placebo to ABY-035 solution for injection
15767901|NCT04713059|Genetic|FGFR2|Mutation of FGFR2
15767902|NCT04713046|Biological|CD8 reduced peripheral blood cells taken from related donors vaccinated against HPV16|Patients will receive CD8+ T cell-depleted peripheral blood cells at one of three dose levels following cyclophosphamide: 1) 10^6 CD4+ cells/kg; 2) 5 x 10^6 CD4+ cells/kg; or 3) 10^7 CD4+ cells/kg of recipient ideal body weight.
15767903|NCT04713046|Biological|Non-myeloablative allogeneic bone marrow transplant from related donors vaccinated against HPV16|Standard dosing for bone marrow graft (target dose of 4 x 10^8 nucleated cells/kg) and if progression at Day 90, will receive dose level 1 for the CD8-depleted DLI (106 CD4+ cell/kg).
15767904|NCT04713033|Diagnostic Test|surface electromyogram (sEMG)|A device that measures electrical signals from your skin will be connected to those stickers and will make a graph that is characteristic to your vocal function.
15767905|NCT04713033|Diagnostic Test|flexible laryngoscopy|"A device that examines the throat and nasal passages. The flexible laryngoscope or scope consists of an eyepiece and a fiber-optic light enclosed in a thin, flexible tube. The scope looks like a strand of black spaghetti with a tiny light on the end of it. The scope is inserted through the nose, and can be moved around to help the doctor see all areas of the nasal passages and throat."
15767906|NCT04713020|Other|Intervention:APP educational programs|Use mobile device education programs to improve disease knowledge and self-efficacy of stroke patients, and reduce depression
15767907|NCT04713020|Other|No Intervention:general care|general care
15767908|NCT04713007|Behavioral|Quality of Life Ted Talks|There will be 9 training modules released weekly on the tablet. A survey will be required at baseline, each of the 9 weeks and at 3 months.
15767909|NCT04713007|Behavioral|Quality of Life Supportive Resources|The tablet will be preloaded with cancer information and supportive care resources from the National Cancer Institute. A survey will be required at baseline, each of the 9 weeks and at 3 months.
15767910|NCT04712994|Other|PrEP Optimization Interventions|There will be four strategies or bundles of strategies tested, one bundle in each of the four interrupted-time series evaluations. Three of the bundles of strategies will be determined based on the qualitative information gathered in Aim 1 by stakeholders and are unknown at this time. One bundle of strategies is pre-developed and includes 3 components: video-based PrEP counselling, HIV Self-Testing [HIVST] for women undergoing repeat HIV testing, and optimized PrEP delivery and prescription processes
15767911|NCT04712981|Other|Behavioral Intervention|Peer leaders/role models will be trained in HOPE intervention fundamentals and assigned to online community groups with participants.
15767912|NCT04712968|Behavioral|Regular exposure to morning daylight|"Participants are asked to stay outside in morning daylight for minimum 30 minutes each day before 1 pm for 6 weeks. A specific plan for individual outdoor possibilities for daylight exposure is made (e.g. a walk, a stay in a park or in their garden, a bike trip). Furthermore a detailed instruction to the personal light tracker LYS Button and the matching LYS Insight app is provided. The LYS Insight app gives the user access to real-time insight of light stimulus. Further, the participants receive psycho-education on the connection between exposure to morning daylight and antidepressant effect. All participants in this group receive the intervention as add-on to usual treatment, which may comprise prescribed antidepressants, psychotherapy, including psycho-education and psychiatric care."
15767913|NCT04712955|Other|Bloodflow restricted exercise|Low-intensity bloodflow restricted resistance exercise is conducted as traditional knee extension exercise with a load corresponding to 30% of 1 repetition maximum (RM), with concurrent partial occlusion of the circulation by means of inflatable pneumatic cuffs wrapped around the proximal part of the thighs. Cuffs are inflated to a pressure corresponding to 50% of the arterial occlusion pressure, which only compromises venous but not arterial blood flow.
15767914|NCT04712942|Drug|Pevonedistat|Patients receive pevonedistat at 20 mg/m2 i.v. (d1,3,5, q4w) up to 12 cycles
15767915|NCT04712942|Drug|Azacitidine|azacitidine is given at a standard dose of 75 mg/m² (d1-7 or 1-5,8,9, q4w) up to 12 cycles
15767916|NCT04712929|Other|Fluconazole|( Tab Fluconazole 100 mg as a mouthwash ( tablet dissolved in 10 ml of drinking water and used as a rinse for 2 minute and swallowed) once a day for 14 days WHO criteria 5As and 5Rs for tobacco cessation
15767917|NCT04712916|Behavioral|Health education|Individualized education intervention on medication use, appropriate diet and physical activity was explained to participants. Participants were guided on achieving recommended metabolic equivalent per week (MET) physical activity considering their health status and daily activities. Furthermore, participants were guided on appropriate dietary recommendation and resolving non-adherence behaviour to medication(s), diet and physical activity.
15767918|NCT04712903|Drug|Durvalumab|Durvalumab 1500 mg via IV infusion over 60 minutes on Day 1 of each cycle.
15767919|NCT04712903|Drug|Cisplatin|Cisplatin as an IV infusion per local standards (usually over 60 to 120 minutes on Day 1) of each cycle.
15767920|NCT04712903|Drug|Etoposide|Etoposide sequentially administered per local standards (usually over 30 to 60 minutes IV infusion) on Days 1, 2, and 3 of each cycle.
15767921|NCT04712903|Drug|Carboplatin|Carboplatin as an IV infusion per local standards (usually over 30 to 60 minutes on Day 1) of each cycle.
15767922|NCT04712877|Diagnostic Test|ctDNA, tumor NGS|Testing for actionable oncogenic drivers
15767923|NCT04712864|Biological|LB1901|LB1901 - an autologous CD4-targeted CAR-T immunotherapy
15767924|NCT04712851|Biological|Pembrolizumab|Given IV
15767931|NCT04712825|Behavioral|Cognitive-behavioural therapy|Cognitive-behavioural therapy sessions during 6 weeks of treatment
15767932|NCT04712825|Device|HypnoVR® device|HypnoVR® sessions during 6 weeks of treatment
15767933|NCT04712799|Drug|Otrivin|oxymetazoline nasal spray
15767934|NCT04712786|Other|pars plana vitrectomy|23 gauge pars plana vitrectomy was performed for retinal detachment, vitreous hemorrhage or epiretinal membrane
15767935|NCT04712773|Device|PMD-200 monitor|Patient is connected to non-invasive PMD-200 monitor, measuring Nociception Level
15767936|NCT04712773|Device|Surgical Pleth Index monitor|Patient is connected to non-invasive monitor measuring Surgical Pleth Index
15767937|NCT04712747|Procedure|Ophthalmological examinations|"OCT (Optical Coherence Tomography): posterior pole OCT B scan , optic nerve and posterior pole OCT Angiography
~Adaptive optics (AO) : Image acquisition on the vessels at the exit of the optic nerve before the first upper temporal bifurcation OD or OG and evaluation of the photoreceptor mosaic. Adaptive optics may require dilatation of the pupil with a drop of tropicamide in the eye examined a few minutes before the examination.
~Color retinophotography
~Measurement of intraocular pressure
~Patients with stroke : At the inclusion visit and 3 months after their stroke Control group : At the inclusion visit."
15767938|NCT04712747|Procedure|Blood pressure measurement at rest|At the inclusion visit
15767939|NCT04712734|Drug|Iloperidone|oral tablet, long-acting injection
15767940|NCT04712721|Drug|68Ga-FF58|single intravenous radio-labelled FF58 Gallium ligand injection determined by body weight (3 Mega Becquerel (MBq)/Kg (+/- 10%)). Administered dose must not be lower than 150 MBq or higher than 250 MBq.
15767941|NCT04712708|Device|Rebound Therapy|Rebound therapy is the therapeutic use of full sized trampoline or mini sized trampoline. It provides opportunities for exercise recreation and therapy; and it is distinct from gymnastic trampolining. It is used for facilitating movements, improving balance, enhancing coordination and promoting motor performances in children with different disorders includes learning disabilities, communication disorders and motor dysfunction (Rebound Therapy South Africa, 2020; The Chartered society of Physiotherapists, 2016).
15767942|NCT04712708|Other|Physical Therapy Program|"The Mat Exercises:
~Stretching exercises to all spastic muscle groups (Kalkman et al., 2018). Gentle exercises was applied for 40-60 seconds and repeated from 3-5 times/ movement as supported by (Fragala et al., 2003).
~Strengthening Exercises:
~Dynamic Rising Positioning
~The Gym Exercises:"
15767943|NCT04712695|Other|Exercise Based Interventions|Proprioception Training Interventions
15767944|NCT04712682|Other|Assessment of neck posture.|pain, pain threshold, CVA angle, muscle strenght test, joint position sense test
15767945|NCT04712669|Drug|Rodatristat Ethyl 300 mg tablet|Rodatristat ethyl is a tryptophan hydroxylase (TPH) inhibitor designed to block peripheral serotonin production.
15767946|NCT04712669|Drug|Placebo|Inactive pill manufactured to mimic rodatristat ethyl
15767947|NCT04712656|Device|CPAP therapy|CPAP treatment of obstructive sleep apnea.
15767948|NCT04712643|Drug|Atezolizumab|Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until participant experience loss of clinical benefit as evaluated by the investigator or unacceptable toxicity or withdrawal of informed consent.
15767949|NCT04712643|Drug|Becavizumab|Bevacizumab will be administered by IV infusion at a fixed dose of 15 mg/kg on Day 1 of each 21-day Cycle.
15767950|NCT04712643|Device|Transarterial chemoembolization (TACE)|TACE will be performed by clinical demand.
15767951|NCT04712630|Procedure|Non-incised papila surgical approach without grafting biomaterial|Periodontal reconstructive surgery
15767952|NCT04712630|Procedure|Non-incised papila surgical approach with grafting biomaterial|Periodontal reconstructive surgery
15767953|NCT04712604|Behavioral|My Sleep Our Sleep (MSOS) Program|MSOS Program is a weekly one-hour Zoom session that focuses on psychoeducation on sleep health for both patients and their sleep partners.
15767954|NCT04712578|Dietary Supplement|Caffeinated pre-workout supplement|The intervention will consist of consuming a standardized meal followed by one serving of the commercially available Pulse caffeinated pre-workout supplement (Legion Athletics, Inc.).
15767955|NCT04712578|Dietary Supplement|Non-caffeinated pre-workout supplement|The intervention will consist of consuming a standardized meal followed by one serving of the commercially available Pulse non-caffeinated pre-workout supplement (Legion Athletics, Inc.).
15767956|NCT04712578|Dietary Supplement|Placebo|The intervention will consist of consuming a standardized meal followed by a placebo beverage.
15767957|NCT04712565|Device|Astra Tech Implant System Profile EV|dental implant with a sloped neck configuration
15767958|NCT04712565|Device|Astra Tech Implant System EV|dental implant with a conventional neck configuration
15767959|NCT04712552|Procedure|deep brain stimulation|"On the day of surgery, under general anesthesia, a Fischer ZD frame will be attached to the skull. A T1-weighted 3D MRI with gadolinium will be performed.
~Investigators will plan on this MRI, anatomical targets and deep brain trajectories using the NeuroInspire surgical planning software.
~The patient will be attached to the base of the robot through the frame. Registration will be performed using the Neurolocate method after the acquisition of 3D CT images using the O-arm. The Neurolocate recording is based on radiographic images.The 3D MRI will be merged with the 3D tomography images taken with the O-arm to co-register the trajectories planned on the MRI in the robot space The surgical procedure will be performed as usual by milling the bone at the entry point and inserting under robotic guidance an electrode through a guide tube to the intended target."
15767960|NCT04712539|Drug|Baloxavir Marboxil|Given PO
15767961|NCT04712539|Drug|Oseltamivir|Given PO
15767962|NCT04712526|Device|AEON Endostapler|Surgery with AEON Endostapler
15767963|NCT04712513|Diagnostic Test|Dynamic cardiac CT perfusion imaging|Multiple images of the heart are acquired with a clinical CT scanner after an intravenous bolus injection of contrast solution. The images are then analyzed to provide fractional flow reserve and myocardial perfusion values.
15767964|NCT04712500|Drug|AND017|AND017 oral capsule
15768021|NCT04712071|Drug|Ketamine Hydrochloride|Patients with a diagnosis of Gulf War Illness using Kansas Criteria will be enrolled to receive a single 40 minute infusion of 0.5 mg/kg ketamine.
15767965|NCT04712487|Diagnostic Test|Microbiological culture, viral PCR, histopathological analysis|"Intervertebral disc tissue was sent to the laboratory for further analysis:
~Microbiological culture: Detection of bacterial growth Viral PCR: Detection of Herpes-Simplex-Type 1 virus, Herpes-Simplex-Type 2 virus, Cytomegalovirus Histopathological analysis: Inflammation signs of disc tissue"
15767966|NCT04712474|Behavioral|In-home decluttering practice|"The in-home decluttering intervention comprises 10, 1.5-hour home-visits over the course of 10 weeks.
~These home visits are personalized, goal-oriented and focused on decluttering. They include 1) a brief check-in, 2) guided unclutter time 3) a reflective period during which participants share their thoughts and objectives for the coming week, and 4) homework assignments."
15767967|NCT04712461|Other|SUPPORTS|The SUPPORTS implementation model will be developed and refined based on community feedback. It will likely include a combination of strategies demonstrated to reduce burnout and secondary traumatic stress in the occupational health literature, such as psychoeducation about burnout, mindfulness training, or changes in scheduling or the physical environment. As the most effective interventions have been shown to involve an integration of both individual- and organization-directed strategies supporting each other, SUPPORTS will aim to include both. For example, the model may include provider-directed strategies such as group peer consultation meetings, and organizational-directed strategies such as increasing communication and providers' involvement in organizational decisions. Through this approach, SUPPORTS will aim to target therapist burnout and turnover at the provider and organizational level.
15767968|NCT04712448|Diagnostic Test|Anti-COVID test|No intervention is foreseen by the protocol
15767969|NCT04712435|Drug|N-acetylcysteine|Eligible patients will be randomised to receive N-acetylcysteine versus matching placebo
15767970|NCT04712435|Drug|Placebo|Eligible patients will be randomised to receive N-acetylcysteine versus matching placebo
15767971|NCT04712422|Other|Healthy subjects|"Participants will be tested for their foot dominance by means of the Waterloo footedness questionnaire-revised, their hand dominance by means of the Edinburgh inventory, and their eyedness Coren's Lateral Preference Inventory.
~Participants will perform a cervical repositioning test. They will seat in a chair in front of a Plexiglas screen with the eye closed. The operator will guide the participant in four positions: at 30° right/left rotation and at 25° extension/flexion. The participant will be then asked to reproduce the angle. Each movement will be repeated four times in a random order. The whole sequence will be repeated by another second operator. Both the tests will be repeated after two weeks.
~Head movements will be detected using an optoelectronic system using passive markers positioned on the head of the participant."
15767972|NCT04712422|Other|Pathologic group|"Clinical evaluation of the participants will be performed by means of the Myotonic Dystrophy Health Index (MDHI), the Rivermead Mobility Index (RMI), the Fall Events Questionnaire, and the Dizziness Handicap Inventory- short form (DHIsf).
~Participants will perform a cervical repositioning test. Participants will seat in a chair in front of a Plexiglas screen with the eye closed. The operator will guide the participant in four positions: at 30° right/left rotation and at 25° extension/flexion. The participant will be then asked to reproduce the angle. Each movement will be repeated four times in a random order.
~Head movements will be detected using an optoelectronic system using passive markers positioned on the head of the participant.
~Participants will then perform test of balance in standing, using the EquiTest platform. Individuals will be requested to perform three different tasks: sensory organization test, adaptation test-upward tilt, and adaptation test-downward tilt."
15767973|NCT04712409|Procedure|Single anastomosis duodeno-ileal bypass|Sleeve gastrectomy followed by division of the duodenum bypassing the jejunum with end-to-side duodeno-ileal diversion
15767974|NCT04712409|Procedure|Biliopancreatic diversion with duodenal switch|Sleeve gastrectomy, followed by division of the duodenum bypassing the jejunum with end-to-side duedeno-ileal diversion and Roux-en-y entero-enteric anastomosis, leaving 100 cm common channel.
15767975|NCT04712409|Procedure|SADI-S as a revisional procedure|In patients previously submitted to sleeve gastrectomy a single anastomosis duodeno-ileal bypass will be performed as 2nd time surgery
15767976|NCT04712409|Procedure|BPD-DS as a revisional procedure|In patients previously submitted to sleeve gastrectomy a biliopancreatic diversion with duodenal switch will be performed as 2nd time surgery
15767977|NCT04712396|Drug|Capivasertib|Subects will be administered single doses of capiversatib on Day 1 and Day 6.
15767978|NCT04712396|Drug|Itraconazole|Subjects will be administered itraconazole twice daily on Day 3, followed by once daily doses in the morning for 4 days.
15767979|NCT04712383|Combination Product|Fitbit Care intervention arm|Entire suite of Fitbit Care.
15767980|NCT04712370|Procedure|Conventional caudal block|Patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected in the caudal epidural space) by the conventional method (blind technique without ultrasound).
15767981|NCT04712370|Procedure|Ultrasound-guided caudal block|Using ultrasound, patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected in the caudal epidural space).
15767982|NCT04712370|Procedure|Ultrasound guided erector spinae plane Block|Under ultrasound guidance, patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath) at the level of the transverse process of the second lumbar vertebrae(L2).
15767983|NCT04712357|Drug|Vitamin C 500 MG Oral Tablet|Vitamin C 500 MG per day for 10 days
15767984|NCT04712357|Drug|Tenofovir disoproxyl fumarate 300 MG Oral Tablet|Tenofovir disoproxyl fumarate 300 MG per day for 10 days
15767985|NCT04712357|Drug|Tenofovir disoproxyl fumarate 300 MG plus emtricitabine 200 MG Oral Tablet|Tenofovir disoproxyl fumarate 300 MG plus emtricitabine 200 MG per day for 10 days
15767986|NCT04712344|Biological|COVID-19 convalescent plasma|Infusion of a total of three units of COVID-19 convalescent plasma administered on three separate occasions during Day 1 and Day 2 in Addition to standard treatment.
15767987|NCT04712331|Other|Graduated abdominal strengthening exercises|"Graduated abdominal strengthening exercises
~In this study the following equipments will be used to achieve treatment approaches:
~Exercise mat and inflatable Swiss ball 55 cm & 65 cm diameter. Wall bar, wedges, elastic tubing (Thera-band) with resistance ranges from light to very heavy (yellow, red, blue, green, and gray colors)."
15767988|NCT04712331|Device|The Russian current stimulation|The Russian current is used for enhancing muscle; the muscular fiber by the electric stimulation.
15768022|NCT04712058|Drug|Bictegravir / Emtricitabine / Tenofovir Alafenamide Oral Tablet [Biktarvy]|Biktarvy will be administered on the same day of diagnosis. The daily dosing will be continued for 48 weeks.
15767989|NCT04712331|Other|Combination Product: Graduated abdominal strengthening exercises and the Russian current stimulation|"Graduated abdominal strengthening exercises and the Russian current stimulation
~In this study the following equipments will be used to achieve treatment approaches:
~Exercise mat and inflatable Swiss ball 55 cm & 65 cm diameter. Wall bar, wedges, elastic tubing (Thera-band) with resistance ranges from light to very heavy (yellow, red, blue, green, and gray colors).
~The Russian current is used for enhancing muscle; the muscular fiber by the electric stimulation."
15767990|NCT04712318|Procedure|Relex Smile|Procedure/Surgery: Relex Smile The residual myopic refraction on Pseudophakic patients after 6 months using Relex-Smile surgery by VisuMax femtosecond laser. The residual refractive power was min -0.75D.The optical zone (lenticule diameter) and cap diameter were 6.5 and 7.5 mm respectively. After dissection of both anterior and posterior planes, the lenticule was extracted through 120 degree superior 3.5 mm incision and marked with a sterile marker(ViscotMedster).
15767991|NCT04712318|Procedure|Relex smile with fresh corneal lenticule implantation|"VisuMax femtosecond laser performed flap-cut procedure with an energy cut index of 30 nJ (150nJ), spot and track spacing surface cut of 4.5 μm, side cut 2.0 μm were used to create an intrastromal pocket into the patient's cornea to receive the donor lenticule.
~The stromal pocket diameter was set 7.6 to 8.0 mm (1 mm larger than the optical zone of the donor lenticule) and cap thickness was set to 130 μm from corneal surface and a 4 mm superior incision. Hinge position flap was set at 90°, angle 50° and width 4 mm, side cut angle 90°. The pocket was dissected using a blunt spatula washed with normal saline. The lenticule was held with lenticule forceps and gently inserted into the pocket through the 4 mm superior incision.
~In pseudophakic patients with hyperopic astigmatism residual refraction, corneal topography-guided intrastromal fresh lenticular implantation should be performed according to the low K values."
15767992|NCT04712305|Other|No intervention required|No intervention required
15767993|NCT04712292|Procedure|Surgical procedure for cancer|Surgical procedure for cancer may include right or left hemicolectomy, rectal resection, abdomino-perineal resection, total colectomy, proctocolectomy, and others depending on the tumor site and other tumor characteristics. Both groups may undergo the same procedures.
15767994|NCT04712279|Drug|Ivermectin 0.6mg/kg/day|Use of ivermectin 0.6m/kg/day q.d.for 05 days
15767995|NCT04712279|Drug|Ivermectin 1.0mg/kg/day|Ivermectin 1.0mg/kg/day q.d. for 05 days
15767996|NCT04712279|Drug|Placebo|Placebo q.d.for 05 days
15767997|NCT04712279|Drug|Hydroxychloroquine|Hydroxychloroquine 200mg/day q.d. for 05 days
15767998|NCT04712266|Drug|Glucagon|calculated IV insulin:Glucagon molar ratio
15767999|NCT04712266|Drug|Insulin|calculated IV Insulin dose infused at a constant rate
15768000|NCT04712240|Device|Respiration rate monitor|A portable continuously monitoring respiration rate monitor will be fitted to each participant. The respiration rate monitor is housed within a comfortable chest strap that be secured to the participant for the duration of the surgical procedure
15768001|NCT04712227|Other|intubation|intubation
15768002|NCT04712227|Other|mask ventilation|mask ventilation
15768003|NCT04712214|Device|Intra-operative multispectral / hyperspectral analysis|During surgery, the operating surgeon will be using standard NHS neurosurgical equipment such as an endoscope and/or a microscope. This equipment is operated in exactly the same way as with any other procedure, but either the microscope or the endoscope in use will be connected to the system of camera and filters for multispectral/hyperspectral analysis. During each surgical intervention, tissue-specific spectral data will be collected at specific stages - mostly once the brain surface is exposed and at the end of the resection on the surgical cavity. The operation will be visually recorded in order to sync visual data with the spectral data obtained at the same moment in time. The video recording will not be patient identifiable and will be viewed only by members of the research team working on this project (see below). The use of video recording equipment will be included in the patient information sheet given to all patients prior to gaining consent
15768004|NCT04712201|Procedure|En bloc transurethral resection of bladder tumor (TURBT)|En bloc transurethral resection of bladder tumor using thulium:yttrium aluminium garnet, monopolar and bipolar energy
15768005|NCT04712201|Procedure|Conventional TURBT|Conventional transurethral resection of bladder tumor using monopolar and bipolar energy
15768006|NCT04712188|Diagnostic Test|Musculoskeletal ultrasonography|The ultrasonographic assesment will be used to examine the supraspinatus tendon thickness, the long head of the biceps brachii tendon thickness and acromio-humeral distance before and after wheelchair propelling test.
15768007|NCT04712188|Other|Wheelchair propelling test|Participants will use their own wheelchairs with their preferred stroke pattern for 20 minutes at a speed of 1 m / s on a motorized treadmill for a wheelchair propelling test. Wheelchair propelling videos will be recorded during the test. Shoulder kinematics will be analyzed using Kinovea motion analysis software and stoke pattern will be confirmed
15768008|NCT04712175|Diagnostic Test|Nasopharyngeal sampling|Swabs will be taken of nasopharyngeal samples for RT-PCR
15768009|NCT04712175|Diagnostic Test|Saliva sampling|A 10ml saliva sample will collected in a sterile 60ml bottle for mass spectrometry and RT-PCR
15768010|NCT04712162|Other|Other|Compare time to awakening and quality of recovery after general anesthesia between two groups.
15768011|NCT04712149|Device|Weekly digital follow up|weekly digital follow-up by sending a questionnaire to patients and sending alerts based on the questionnaire to the care team
15768012|NCT04712136|Other|MRI|MRI cardiac
15768013|NCT04712123|Other|relapse due to S. aureus|to find out if it is the same S. aureus in both infections
15768014|NCT04712110|Biological|TAK-019|TAK-019 intramuscular injection
15768015|NCT04712110|Biological|Placebo|Placebo intramuscular injection
15768020|NCT04712084|Procedure|Positive pressure|Inspiratory support of 8 cmH2O was applied associated with PEEP at 6 cmH2O. After extubation, same support was applied by facemask for 3 minutes
15768023|NCT04712045|Other|New PPE|The use of a new protocol of level 2 PPE which involves wearing a short-sleeve gown and a single pair of gloves
15768024|NCT04712045|Other|Old PPE|The use of a standard protocol of level 2 PPE which involves wearing a long-sleeve gown and double pairs of gloves
15768025|NCT04712032|Drug|ICG-guided bowel perfusion assessment|ICG will be injected prior to anastomosis creation, to assess perfusion status of the bowel.
15768026|NCT04712019|Device|Closed Incision Negative Pressure Therapy (ciNPT)|Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric at 125mmHg of continuous negative pressure on a closed surgical incision
15768027|NCT04712019|Device|Standard Silver-containing Dressing|A standard silver-containing dressing applied to a closed surgical incision
15768028|NCT04712006|Drug|JNJ-64304500|Participants will be administered with JNJ-64304500 SC (Dose 1 or 2) injection on Day 1.
15768029|NCT04711993|Other|Aerobic exercise|"Patients will do aerobic exercise three days a week for 40 minutes during 8 weeks. Aerobic exercise protocol will consist of warm up, loading and cooling periods. . Exercise prescription will be prepared in line with the recommendations of The American College of Sports Medicine."
15768030|NCT04711993|Other|Stretchin exercise|Patients will do stretching exercise three days a week for 40 minutes during 8 weeks. Stretching exercises will start with active warm-up activities. Static stretching method will be used.
15768031|NCT04711980|Drug|Mudan granule|"Mudan granule,a traditional Chinese medicine formula,consists of nine Chinese herbs.
~Other: Standard medical care.Standard medical care is in accordance with China Guideline for type 2 diabetes (2013)."
15768032|NCT04711980|Drug|Placebo|"Granule(Placebo) is in accordance with Mudan granule in appearance, colour, taste.
~Other: Standard medical care. Standard medical care is in accordance with China Guideline for type 2 diabetes (2013)."
15768033|NCT04711967|Biological|Fecal Microbiota Transplantation|fecal microbiota transplantation
15768034|NCT04711967|Drug|drug|drug
15768035|NCT04711941|Behavioral|Rehabilitation training|Rehabilitation with behavioural stimuli
15768036|NCT04711928|Behavioral|Physical activity and sedentary behaviour|Athletes with a high physical activity and a low or high sedentary time
15768037|NCT04711915|Drug|0.1 mg/kg Dimethyltryptamine (DMT)|0.1 mg/kg DMT
15768038|NCT04711915|Drug|0.3 mg/kg Dimethyltryptamine (DMT)|0.3 mg/kg DMT
15768041|NCT04711889|Drug|Ulinastatin|Ulinastatin is taken three times a day.
15768042|NCT04711889|Drug|Saline|Saline is taken three times a day.
15768043|NCT04711876|Biological|Cytokine level in blood and CSF|Measure of cytokine level
15768044|NCT04711863|Drug|Fluvoxamine|Up to 200 mg per day as tolerated until discharge from community treatment center or for approximately 10 days
15768045|NCT04711863|Drug|Placebo|Up to 200 mg per day as tolerated until discharge from community treatment center or for approximately 10 days
15768047|NCT04711837|Drug|HSK3486|HSK3486 for induction of general anesthesia.
15768048|NCT04711837|Drug|Propofol|Propofol for induction of general anesthesia.
15768053|NCT04711811|Biological|HB-adMSC|Hope Biosciences adipose derived autologous mesenchymal stem cell product
15768054|NCT04711798|Other|passive leg raising maneuver (PLR)|Passive leg raising maneuver (PLR) for preload status evaluation using the PICCO system will be realized in Phase 1 (pre operatively), Phase 2 (after the sternotomy closure in the operating room), Phase 3 (H+2 of the arrival in cardiac intensive care unit).
15768055|NCT04711798|Other|lung recruitment maneuver (LRM)|lung recruitment maneuver (LRM) will be realized in Phase 1 (pre operatively), Phase 2 (after the sternotomy closure in the operating room), Phase 3 (H+2 of the arrival in cardiac intensive care unit).
15768056|NCT04711798|Other|echographic evaluation of the right cardiac function|echographic evaluation of the right cardiac function will be realized in Phase 1 (pre operatively), Phase 2 (after the sternotomy closure in the operating room), Phase 3 (H+2 of the arrival in cardiac intensive care unit).
15768057|NCT04711785|Behavioral|Multicomponent exercise program|"The exposed group will carry out the following program of specific muscle strength and cardio physical activity aimed at reducing frailty.
~For 2.5 hours per week."
15768058|NCT04711772|Other|whole-genome sequencing|Whole-genome sequencing will be preformed for each participate to explore the potential disease-causing genes of DOR.
15768059|NCT04711759|Device|High flow nasal cannula|High flow nasal cannula will be provided through a commercial device (AIRVO2 + Optiflow nasal cannula, Fisher & Paykel), at 50 LPM and at the same FiO2 applied during the spontaneous breathing trial.
15768060|NCT04711759|Device|Standard oxygen therapy|Standard oxygen therapy will be provided through a Venturi mask and O2 flow will be adjusted to keep the same FiO2 applied during the spontaneous breathing trial.
15768061|NCT04711746|Biological|blood sample|Blood sample withdrawal in order to perform DNA sequencing
15768062|NCT04711733|Other|Interview|The qualitative interview aims to identify the supportive care needs of patients and parents as well as their expectations with regard to a long-term follow-up.
15768090|NCT04711512|Behavioral|Encouragement/Support|Messages that focus on improving self-efficacy and motivation for physical activity
15768091|NCT04711512|Behavioral|Social Comparison|Messages that provide exposure to another person's physical activity engagement data (for comparison)
15768063|NCT04711733|Other|Self-report questionnaire|"To assess the quality of life, anxiety/depression of former patients and relatives:
~For child and adolescent patients (less than 15 years old at inclusion):
~Pediatric Quality of Life Inventory Cancer module
~Screen for Child Anxiety Related Emotional Disorders Revised
~Children's Depression Inventory
~For patients over 15 years of age at the time of inclusion and parents:
~36-Item Short Form Health Survey
~Hospital Anxiety and Depression Scale
~To describe and evaluate the offer and use of the network of health professionals who are aware of post-treatment issues: number of consultations, speciality and location of the professionals requested following the long-term follow-up consultation, time between referral and first consultation, evaluation of the geographical accessibility of care around the patient's home."
15768064|NCT04711733|Other|Medical consultation|"To assess adherence to long-term follow-up medical consultation:
~- number of patients summoned/ number of consultations carried out ; reason for refusal of long-term follow-up medical consultation To assess medical complications through clinical data collection"
15768065|NCT04711720|Device|"VTS surgical navigation system"|"TheVTS surgical navigation system can accurately match the preoperative and intraoperative image data with the patient's anatomical structure on the operating table, track the surgical instruments during the operation, and update the position of the surgical instruments on the patient's image in real time, so that the doctor can clearly understand the position of the surgical instruments relative to the patient's anatomical structure, and make the operation procedure more accurate and safer."
15768066|NCT04711707|Other|Community navigator|All patients who consent to participate in the study will complete a pediatric social history tool to identify social needs. The intervention group will receive support through a community navigator to guide and understand appropriate services for their specific needs. This arm will receive guidance and bimonthly check-ins.
15768067|NCT04711707|Other|Self-Navigation|The control group will receive an electronic or paper copy of community resources that address the identified social needs.
15768068|NCT04711694|Behavioral|Minfulness-based Intervention|"The proposed MBI is an adaptation from the Mindfulness Based Stress Reduction (MBSR) and Mindfulness based Cognitive Therapy (MBCT) programs to youth. This MBI consists of a total of twelve 90 minutes long sessions, the first 8 being the intervention per se and the last 4 a proposition to the transition to regular practice and a chance to better integrate mindfulness in daily life.
~A theme regarding mindfulness is addressed in each session, through meditation practices and exercises. Between sessions, participants are invited to practice at home, using an application designed for this study (the MindApp), where participants can find the recorded practices. Investigators have access to participants' use of the meditation recordings and expect that these data will provide a more objective measure of the amount of home practice."
15768069|NCT04711681|Behavioral|Positive Behavior Supports in Middle Schools|"2-4 days SWPBS training for school team and 1-2 days for whole staff training (SW and Classroom Management). Use staff release days for whole staff training.
~Schedule up to four meetings with the PBS team
~1K/School is to fund part or whole day training meeting with PBS team Schedule whole staff training per school year staff release days Enhanced Intervention Family Support Universal -- parent education and invitation Selective -- Family Check up School Intervention ACT for teachers PBS Calendar Kernel Recipes (Treatment) Reminder Emails Brochures Weekly phone contact (Treatment)"
15768070|NCT04711681|Behavioral|Positive Behavior Supports in Middle Schools|1 days PBS training for school team and informational presentation to whole staff Attend 2-3 PBS team meetings (coaching) Data-based feedback (limited)
15768071|NCT04711668|Drug|Ketamine|intraoperative ketamine bolus and infusion
15768072|NCT04711668|Drug|Lidocain|intraoperative lidocain bolus and infusion
15768073|NCT04711668|Drug|Saline|intraoperative saline bolus and infusion
15768074|NCT04711655|Procedure|ARMA (antireflux ablation of the cardiac mucosa)|is an endoscopy in which argon gas ablation of the cardiac mucosa
15768075|NCT04711655|Procedure|upper digestive endoscopy|Quality diagnostic upper gastrointestinal endoscopy will be performed without intervention in patients assigned to this treatment arm.
15768076|NCT04711642|Drug|The study will include three arms, one non interventional and 2 interventions. The intervention arms will include two commercially available sodium hyaluronate 0.1% (Systane ultra plus and Hylo-comod)|All groups will receive a topical steroid-antibiotic for 3 weeks. The study groups will be also prescribed eye drops containing sodium hyaluronate 0.1% from the postoperative day 7 for 4 weeks.
15768077|NCT04711629|Other|Clinical Tests|Respiratory function test, arterial blood gas analysis, six-minute walking test (6-MWT), mMRC Dyspnea Scale, St George Quality of Life Questionnaire and Hospital Anxiety Depression Scale
15768078|NCT04711616|Behavioral|physical therapy intervention|physical therapy interventions include thermal therapy, electrical therapy, manual therapy, and therapeutic exercise.
15768079|NCT04711603|Drug|MR13A9|Intravenous administration
15768080|NCT04711603|Drug|Placebo|Intravenous administration
15768081|NCT04711590|Other|Microcirculation examination|Sublingual microcirculation images were recorded using an incident dark-field video microscope
15768082|NCT04711577|Behavioral|Track clinician-determined symptoms|Participants will track clinician-determined symptoms
15768083|NCT04711577|Behavioral|Track clinician-determined and self-determined symptoms|Participants will track clinician-determined symptoms and a self-determined symptom
15768084|NCT04711564|Other|Olive oil-based intravenous fat emulsions|Parenteral nutrition planned according to the requirements of the patients is given for ten days.
15768085|NCT04711564|Other|Soybean-based intravenous fat emulsions|Parenteral nutrition planned according to the requirements of the patients is given for ten days.
15768086|NCT04711551|Combination Product|PRP and related devices to abtain platelet concentrate from whole blood, medullary and adipose tissue and related devices|PRP and related devices to abtain platelet concentrate from whole blood, medullary and adipose tissue and related devices
15768087|NCT04711538|Device|MRI|imaging inner ear and petrous bone of the candidate by MRI and CT
15768088|NCT04711525|Behavioral|Experimental Group: Interactive Malaysian Childhood Healthy Lifestyle Program (i-MaCHeL)|The preschool children in the experimental group will be received the i-MaCHeL program delivers through interactive classroom instruction, and their parents will have access to the i-MaCHeL Web-based program.
15768089|NCT04711525|Behavioral|Control Group: Standard health education|The children in the control group will be continued with standard health education only in the preschool setting, and their parents will be received general Web-based health newsletters.
15768092|NCT04711499|Behavioral|Fatigue|The intervention will be assessing the participant in a fatigued state compared to a non fatigued state
15768093|NCT04711486|Drug|Contraloid acetate|Oral administration of drug substance capsules
15768094|NCT04711486|Drug|Placebo|Oral administration of placebo without any exipients.
15768095|NCT04711473|Behavioral|Colonoscopy Only|Mailed letter asking participants to complete CRC screening by colonoscopy
15768096|NCT04711473|Behavioral|Choice|Mailed letter and FIT test asking participants to complete CRC screening by their choice of either colonoscopy or mailed FIT
15768097|NCT04711473|Behavioral|FIT Only|Mailed letter and FIT test asking participants to complete CRC screening by mailed FIT
15768098|NCT04711460|Behavioral|observation|Young participants versus Old participant scores at admission and discharge were compared
15768099|NCT04711447|Device|kinesio-tape|Twenty-one individuals with healthy shoulders completed 10 repetitions of an arm elevation task during three taping conditions (no-tape, experimental KT, sham KT) and 2 loading conditions (no-load and loaded).
15768100|NCT04711434|Drug|PD-1 Antibody|Toripalimab: 240mg IV every 3 months for a year
15768101|NCT04711421|Device|4 VIVOFIT-|Feedback on number of steps taken by patint, as recorded by pedometers, provided by research team
15768102|NCT04711408|Device|SootheVR: AppliedVR, Los Angeles, California a head-mounted displa|"For the study group, virtual reality content will be administered to the participant for the duration of the examination through a head-mounted display, RelieVRTM. The VR content for the trial will be swimming with dolphins."
15768103|NCT04711395|Device|measure the preoperative DLI、 SS-OCT image of the lens,、take photos of the anterior segment and self-scoring of the preoperative visual quality assessment scale.|subjects in the observation group and Healthy used iTrace ocular aberration analyzer（itracey Technologies）and IOL-Master 700 biometer to measure the preoperative DLI(Dysfunctional lens index) and SS-OCT image of the lens, and The researchers used the anterior segment slit lamp to take photos of the anterior segment of the subject's lens in a state of dilated pupils .and self-scoring of the preoperative visual quality assessment scale.
15768104|NCT04711369|Device|Erbium:Yag laser|"Vulvovaginal laser therapies will be performed with the non-ablative 2940 nm Er:YAG laser (Smooth XS, Fotona, Slovenia) in the Renova mode according to the manufacturer's guidelines and recommendations. The spot size (diameter of the laser beam) is 7 mm, with a pulse at a frequency of 1.6 Hz, and a fluence (laser energy delivered per unit area) of 5.0 to 10.0 J/cm2.
~All sensitive/painful areas of the introitus will be treated, using 1-3 repetitions.
~In postmenopausal women with signs of atrophy, additional irradiation of the vaginal wall will be performed."
15768105|NCT04711369|Device|Sham Erbium:Yag laser|"Clinical examination and preparations will be identical to the intervention group. Sham laser treatments will be performed with the same laser and the same procedures. However, a specially devised placebo probe with a steel shutter, which blocks the emission of radiation, will be used. Women will therefore receive no therapeutic irradiation. Before treatment, a study assistant, who is aware of the study allocation, will prepare the laser with the placebo probe, which looks identically to the normal probe. The treating physician will not be aware of the study allocation and the type of probe in use."
15768106|NCT04711356|Drug|Ad26.ZEBOV booster vaccination, given at a dose of 5x10^10 vp, via IM injection|Ad26.ZEBOV is a monovalent, replication-incompetent adenovirus serotype 26-based vector that expresses the full-length Ebola virus Mayinga glycoprotein
15768107|NCT04711343|Drug|BAT2306|150mg/1 ml; single dose；prefilled syringe; subcutaneous injection
15768108|NCT04711343|Drug|Cosentyx (US-licensed)|150mg/1 ml; single dose；prefilled syringe; subcutaneous injection
15768109|NCT04711343|Drug|Cosentyx (EU-licensed)|150mg/1 ml; single dose；prefilled syringe; subcutaneous injection
15768110|NCT04711317|Device|Nasal high flow oxygen|Pregnant women scheduled for cesarian section in general anaesthesia will be preoxygenated using nasal high flow oxygen
15768111|NCT04711304|Biological|Umbilical Cord-derived Wharton's Jelly|Intraarticular injection
15768112|NCT04711304|Device|Hyaluronic acid|Intraarticular injection
15768113|NCT04711304|Other|Saline|Intraarticular injection
15768114|NCT04711291|Combination Product|Conversion to Envarsus-XR and use of smart phone app, TransMedAx|"Convert to tacrolimus extended release (Envarsus XR) prescribed dose every 24 hours used in combination with the smart phone application, TransMedAx.
~Patients in this arm will be trained to use the app along with conversion to Envarsus-XR. Once patient scan the code on medicine bottle and the app will remind them about the time and dose of the medication in their native language."
15768115|NCT04711291|Drug|Convert to Envarsus XR once daily|Convert from tacrolimus immediate release to tacrolimus extended release (Envarsus XR) prescribed dose every 24 hours
15768116|NCT04711278|Device|Mask-wearing hypnosis|"Virtual mask will be worn by patients before and during surgery of Hallux valgus to realize hypnosis.
~Virtual mask with 2 types of voice: female voice and male voice. Several types of image or music to choice by patient."
15768117|NCT04711278|Other|Without hypnosis|No hypnosis during surgery of Hallux valgus.
15768118|NCT04711265|Drug|Quadrivalent HPV [Type 6, 11, 16 and 18] L1 Virus-Like Particle Vaccine|Intramuscular injection with 3 doses of QHPV
15768125|NCT04711239|Diagnostic Test|PGT-A / niPGT-A|PGT-A and niPGT-A will be performed using next generation sequencing (NGS) analysis for chromosome copy number variation (CNV). Embryo transfers will rely solely on the results of PGT-A for trophectoderm biopsies.
15768126|NCT04711226|Drug|AT-1501|AT-1501 IV infusion
15768127|NCT04711213|Drug|Dexamethasone Dose 1|Dexamethasone ophthalmic suspension dose 1
15768128|NCT04711213|Drug|Dexamethasone Dose 2|Dexamethasone ophthalmic suspension dose 2
15768129|NCT04711213|Drug|Placebo Dose 1|Placebo suspension dose 1
15768131|NCT04711200|Drug|Adipose derived stromal cells intravenously injected|2×10^6/kg of Adipose derived stromal cells A single injection at D0 (performed maximum three days post-admission).
15768132|NCT04711187|Drug|AT-527 Formulation 1|AT-527 Formulation 1 (R07496998)
15768133|NCT04711187|Other|Placebo Comparator|Placebo Comparator
15768134|NCT04711187|Drug|AT-527 Formulation 2|AT-527 Formulation 2 (R07496998)
15768135|NCT04711174|Behavioral|LMA removal|the timing when conducting LMA removal
15768136|NCT04711161|Drug|GRN-300|A salt-inducible kinase inhibitor
15768137|NCT04711161|Drug|Paclitaxel|Microtubule inhibitor
15768140|NCT04711135|Drug|Lutetium [177Lu] oxodotreotide/dotatate|Radiopharmaceutical solution for infusion (7.4 GBq of Lutathera per 30 ml vial)
15768141|NCT04711122|Drug|Third generation cephalosporin antibiotics|Assessment of antibiotic effect
15768142|NCT04711109|Drug|Denosumab|Given SC
15768143|NCT04711109|Drug|Placebo|Given SC
15768144|NCT04711109|Other|Quality-of-Life Assessment|Ancillary studies
15768145|NCT04711096|Procedure|Ultrasound-guided transversus abdominis plane (TAP) block 0.25% bupivacaine.|After preparing the skin with antiseptic solution, a linear high frequency ultrasound probe will be placed abdominal wall between the iliac crest and the costal margin. A Spinal needle 22g attached with flexible tubing to a syringe filled with saline will be used to perform the block then introduced through the skin anteriorly in the plane between the internal oblique and transversus abdominis muscles with its tip lying in the mid axillary line. To assist with identifying these structures, The final position of the probe will to be no further anterior than the anterior axillary line. If satisfactory views are not obtained, the TAP block will not be performed. Hydro dissection with saline (2-5 ml) will be used to separate the fascial layers. After aspiration to exclude inadvertent vascular puncture, 20 ml of the 0.25% bupivacaine will be injected . TAP block will be performed in a similar fashion on the opposite side.
15768146|NCT04711083|Diagnostic Test|overnight pulse oximetry|"Wrist worn Overnight oximetry was performed using portable Nonin 2500 (Nonin Medical Inc., USA) pulse oximeters. The test was explained to the subjects and their caregiver by experienced health-care staff from the sleep unit. The recording was done at home and started just before going to bed and ended on awakening; the recommended duration was a minimum of 5 h and a maximum of 7 h. The awake SpO2, mean SpO2. The data were analysed to calculate the overnight minimum SpO2, mean SpO2, dip frequency (defined as a fall in SpO2 of > 4%), the percentage of oximetry sleep time spent with a SpO2 of < 90%, and the total oximetry time. Recordings were classified as normal (< 4.9 desaturation events an hour), equivocal (5 to 14.9 desaturation events an hour), or abnormal (> 15 desaturation events an hour) according to the severity and pattern of nocturnal desaturation observed ."
15768147|NCT04711057|Other|Community-based PA program|After completing the PR program, the experimental group (EG) will enroll in a 6-month personalized community-based PA program, which should be attended twice-weekly, minimum. During the first month the physiotherapist will guide patients through all available physical activities; afterwards, patients will be asked to choose one or two activities, according to their preference, which they'll attend for five more months. Physiotherapists' support will gradually decrease over time.
15768148|NCT04711057|Other|Pulmonary Rehabilitation|Exercise training, twice a week, and education and psychosocial support once every other week during 12 weeks.
15768149|NCT04711044|Other|Papain|Papain will be applied using cowhage spicules inactivated by heat
15768150|NCT04711044|Other|Histamine|To deliver histamine, standard allergy skin prick test (SPT) lancets are applied
15768151|NCT04711044|Other|Cowhage|Cowhage spicules are 1-2 mm in length and have a diameter of 1-3 μm. The spicules are inserted by gently rubbing 30-35 spicules into a 1 cm diameter skin area.
15768152|NCT04711044|Other|L-menthol|A 1 mL aliquot is dispensed onto a 2,5 × 2,5 cm cotton pad and placed on a 6 × 6 cm sheet of medical tape.
15768153|NCT04711031|Other|FLUS|The participating GPs use ultrasonography on a weekly basis and will use the ultrasonography device already available to them; however, the ultrasound machine system and type of transducer will be reported. The GPs will use a 14-zone FLUS scanning protocol that has previously been validated in a general practice setting. Each of the scanning zones on the patient's left side can be denoted from 1L to 7L and from 1R to 7R on the right side. Each scanning zone should be assessed using FLUS. The transducer is placed in the middle of a scanning zone making a cross sectional image of an intercostal space and the underlying pleura blades. The patients will be examined in an upright position. The GPs will be trained in the 14-zone scanning protocol during a FLUS training program prior to recruitment of patients. FLUS pathological findings are predefined, and the variables will be dichotomized into present or not present for each scanning zone.
15768154|NCT04711018|Diagnostic Test|Laryngoscopy|The laryngoscopy is performed with the help of an appropriate size Macintosh blade. The patient's head is held in the sniffing position. External manipulation is not used for improving the view in this investigation.
15768155|NCT04711005|Drug|(2R,6R)-Hydroxynorketamine hydrochloride|(2R,6R)-Hydroxynorketamine is a metabolite of the drug ketamine. (2R,6R)-Hydroxynorketamine hydrochloride will be administered intravenously over a 40-minute period as a solution in a 25 mM sodium phosphate 0.9% w/v saline solution. The investigational drug product will be diluted into a 53 mL total volume of formulant.
15768156|NCT04711005|Drug|Placebo|Placebo will be made up of a 0.9% w/v saline solution (53 mL total volume) administered via slow IV infusion over a 40-minute period.
15768157|NCT04710992|Procedure|Isolated needling procedure|The needle will be inserted into the common extensor tendon of the epicondyle (dominant elbow) for 90 seconds without galvanic current.
15768158|NCT04710992|Procedure|Low intensity percutaneous electrolysis|Once the needle is located in the common extensor tendon of the epicondyle (dominant elbow), a single impact of galvanic current will be applied with an intensity of 0.3 mA for 90 seconds.
15768159|NCT04710992|Procedure|High intensity percutaneous electrolysis|The needle will be inserted in the target position during the same time as in the other groups (90 seconds). During the first stage of intervention the needle will be imbedded without galvanic current and when the end of the application time approaches (approximately 75 seconds) three impacts of galvanic current will be applied with an intensity of 3 mA and a duration of 3 seconds each.
15768354|NCT04709341|Device|TR Band 60MIN|TR-Band will be in left in place for 15 minutes before it is gradually deflated by 25% at 15 minute intervals
15768160|NCT04710979|Behavioral|Yoga Intervention|This group will have in-person, 60 minute yoga sessions three times per week for 12 weeks. These sessions will also include a sharing circle to provide group feedback as to how the practice felt and integration into ones' daily life. There will be biweekly themes established for these sessions (i.e. common yoga poses, importance of breath) and biweekly in-person workshops will be offered. These will be specialty classes for participants to experience additional exposure to meditation and breathing. They will be a longer format so participants can delve deeper into yogic philosophy and practice. There will also be a private Facebook group for participants to connect with each other and for the research staff to maintain contact and share information with the participants (eg. weekly reminder for yoga sessions and workshops).
15768161|NCT04710966|Procedure|arthroscopic debridement|For the arthroscopic debridement, only stump refreshing and surrounding soft tissue cleaning were performed.
15768162|NCT04710966|Procedure|arthroscopic repair|For the arthroscopic repair, we converted partial tears into full-thickness tears and sutured them.
15768163|NCT04710953|Device|Continuous positive airway pressure machine|CPAP device set at 6-8cmH2O for several hours
15768164|NCT04710940|Behavioral|DM-BOOST|DM-BOOST is a technology based, patient centric behavioral intervention for support of diabetes self-management for patients with T2D.In DM-BOOST, the investigators hypothesize that patients with gaps in recommended diabetes care can be grouped by similar clinical and/or sociodemographic characteristics.
15768165|NCT04710927|Device|Silver Diamine Fluoride|A single application of SDF 38% (Riva Star) on dry affected molar for 1 minute and immediately restored using HVGIC
15768166|NCT04710927|Device|Papain-Based Gel|Papain based Gel (Papacarie Duo) will be applied to the MIH affected molar for 60 seconds and repeated if required. The molar will be treated with SDF and restored using HVGIC
15768167|NCT04710927|Device|High Viscosity Glass Ionomer Cement|The molar will be restored with HVGIC
15768168|NCT04710914|Drug|Prolonged sedation with isoflurane|"Adult patients admitted to the surgical intensive care unit at the Rouen University Hospital for septic shock and requiring sedation for more than 3 days and a maximum of 10 days will be randomised in two groups.
~The experimental group will receive sedation by inhaled isoflurane The control group will receive sedation by intravenous midazolam"
15768169|NCT04710914|Drug|Prolonged sedation with midazolam|"Adult patients admitted to the surgical intensive care unit at the Rouen University Hospital for septic shock and requiring sedation for more than 3 days and a maximum of 10 days will be randomised in two groups.
~The experimental group will receive sedation by inhaled isoflurane The control group will receive sedation by intravenous midazolam"
15768170|NCT04710901|Behavioral|uTECH|"uTECH intervention utilizes video-based, didactic teaching in four areas (PrEP/PEP, medication assisted treatment, sexual risk and substance use harm reduction, and overdose prevention) and a machine learning algorithm that leverages baseline data, individual social media use patterns, and strategic opportunistic learning questions to push messages to participants that offer strategic content about biomedical and behavioral HIV prevention."
15768171|NCT04710901|Behavioral|YMHP|YMHP intervention provides a four-session evidence-based Motivational Enhancement intervention developed as part of the Young Men's Health Project (YMHP) and delivered via Zoom. Participants complete the four-session intervention during the first three months of their enrollment in this study. Months 3-6 are inactive.
15768172|NCT04710888|Drug|use of basil extract gel in treatment of aphthus ulcer|This study aimed to evaluate the efficacy of basil extract (Ocimum basilicum) in the treatment of aphthous ulcers
15768173|NCT04710888|Other|muco adhesive placebo gel|mucoadhesive gel without drug which was used as placebo (contains tragacanth gum, alcohol, sodium benzoate, and distilled water) 4 times per day
15768174|NCT04710888|Other|no treatment|(i) had underlying systemic disease(s) or a history of immunologic disorder(s); (ii) were taking immunomodulatory agents or systemic nonsteroidal anti-inflammatory drugs < 1 month before study commencement; (iii) are smokers; (iv) are pregnant; (v) had a history of abusing drugs or alcohol; (vi) could not provide written informed consent.
15768175|NCT04710875|Drug|Na-lactate|intravenous
15768176|NCT04710875|Drug|Sodium chloride|Intravenous
15768177|NCT04710862|Behavioral|Breathing training without a device|Breathing training without a mouth device
15768178|NCT04710862|Behavioral|Breathing training with a device|Breathing training with a mouth device
15768179|NCT04710849|Diagnostic Test|Serum metabolic markers|Ultraperformance liquid chromatography / mass spectrometry (LC-MS) and gas chromatography / mass spectrometry (GC-MS) methods for analysis of the metabolites in AECOPD patients and compare the metabolites profiles between patients with systemic glucocorticoid treatment success and treatment failure.
15768180|NCT04710823|Procedure|Thoracic paravertebral block|A bolus dose of 0.25% bupivacaine (0.3 ml/kg) will be injected slowly over 3-5 minutes. At 30 minutes after injection of the loading dose, the dermatomal loss of sensation to pinprick was tested. Patients who reported pain to pinprick will be considered to have a failed block and were excluded from the study. The block will be maintained by continuous infusion of bupivacaine 0.25% at a rate of 0.1 ml/kg/h via a syringe pump. The infusion will be continued for 4 days.
15768181|NCT04710823|Procedure|Serratus anterior plane block|A bolus of 30 ml of 0.25% bupivacaine will be injected slowly over 3-5 minutes between latissmus dorsi muscle and serratus anterior muscle (Figure 15). Then a catheter was inserted through the Tuohy needle and advanced 3cm into the space and secured in place. At 30 minutes after injection of a loading dose, the dermatomal loss of sensation to pinprick will be tested. Patients who reported pain to pinprick will be considered to have a failed block and were excluded from the study. The block will be maintained by continuous infusion of bupivacaine 0.25% at a rate of 0.1 ml/kg/h via a syringe pump. The infusion was continued for 4 days.
15768203|NCT04710706|Other|Colonoscopy insertion technique used during procedure|Each arm is using a different colonoscopy insertion technique: either water-alone colonoscopy or water-CO2 colonoscopy.
15768204|NCT04710693|Diagnostic Test|CAD polyp-detection system|Software will be used during the procedure to aid the detection of polyps during the procedure.
15768205|NCT04710680|Other|no intervention|no intervention
15768206|NCT04710654|Other|connective tissue manipulation|Individuals in CTM group, will sit on a stool with hips and knees flexed at 90° and their hands free on the thighs. The application will start from the basic area in the first session, and in the other sessions, the lower thoracic, scapular, inter-scapular and cervical regions will be included in the treatment as soon as possible according to the state of the vascular reaction. CTM will be applied three days a week, for four weeks.
15768182|NCT04710810|Other|umbilical cord blood mononuclear stem cells|UCB samples (70-130 ml of initial volume) were aseptically drained in blood-collection bags with 35 mL of citrate phosphate dextrose (CPDA-1) anticoagulant. Red blood cell-depleted/plasma-reduced nucleated cells were isolated by sedimentation in dextran-40, resuspended in autologous plasma with 10% dimethylsulfoxide and 1% dextran-40, and aliquoted in 3.8 ml vials with target doses of 3.0±0.2 x 10⁶ cells per vial. Vials were cooled to -90⁰C, quarantined in the vapor phase of liquid nitrogen. Tested for HIV-1/2, hepatitis B and C, HTLV-1/2, HSV-1 and -2, CMV, syphilis, and sterility. Characterized by AB0/Rh, CD34/CD45-positive cell content. Before injection sample thaws in the water bath at +37⁰C and washes from an excess amount of DMSO in 40 mL of physiological saline containing 2.5% human serum albumin and 5% dextran-40. After centrifugation and supernatant withdrawal, the UCB resuspends in 40 ml of the same solution at a target dose of 250±10 x 10⁶ viable cells per sample.
15768183|NCT04710797|Procedure|Completion staging surgery including systematic pelvic and para-aortic lymphadenectomy|"open or minimally invasive surgical approach
~cytologic examinations
~All peritoneal surfaces should be visualized, and any peritoneal suspicious for metastasis should be selectively excised or biopsied
~BSO and hysterectomy
~For selected patients desiring to preserve fertility, USO or BSO with uterine preservation may be considered
~Omentectomy
~Para-aortic lymph node dissection should be performed by stripping the nodal tissue from the vena cava and the aorta bilaterally to at least the level of the inferior mesenteric artery and preferably to the level of the renal vessels
~The preferred method of dissecting pelvic lymph nodes is bilateral removal of lymph nodes overlying and anterolateral to the common iliac vessel, overlying and medial to the external iliac vessel, overlying and medial to the hypogastric vessels, and from the obturator fossa at a minimum anterior to the obturator nerve"
15768184|NCT04710797|Procedure|Comprehensive staging surgery with no Lymphadenectomy|"open or minimally invasive surgical approach
~cytologic examinations
~All peritoneal surfaces should be visualized, and any peritoneal suspicious for metastasis should be selectively excised or biopsied
~BSO and hysterectomy
~For selected patients desiring to preserve fertility, USO or BSO with uterine preservation may be considered
~Omentectomy
~In open approach surgery, exploring the pelvic and Para-aortic lymph node with hand. In minimally invasive surgery, the peritoneal above the pelvic and Para-aortic lymph node area should be open and visualized.Biopsy and frozen section of the suspicious lymph nodes"
15768185|NCT04710784|Behavioral|Sexual health information|We will provide participants with sexual health information, that is basic, accurate, and directly contributes to health-promoting decisions and behavior, once a week at the beginning of the study.
15768186|NCT04710784|Behavioral|I-TEST branded HIVST package|The I-TEST branded HIVST package will include HIV self-testing (HIVST) kits, referral coupons, condoms, female or male hygiene products, and instructions on how to use the I-TEST photo verification App or USSD (Unstructured Supplementary Service Data) system to verify the HIVST results. Study participants will be referred to a youth-friendly health clinic for confirmatory HIV testing, STI testing (syphilis, gonorrhea, chlamydia, and hepatitis B), STI treatment and PrEP referral.
15768187|NCT04710784|Other|Follow-up testing and clinic assessments|Information to encourage routine retesting for HIV every 6 months and linkage to the youth-friendly clinic for confirmatory HIV testing, STI testing (syphilis, gonorrhea, chlamydia, and hepatitis B), STI treatment, and PrEP referral. Additionally, follow-up surveys will be administered to assess HIV testing, sexual behavior history, youth participation experience, and other related outcomes will be collected from enrolled participants.
15768188|NCT04710771|Other|Prone Lying Position|patient lies on his/ her stomach facing floor.
15768189|NCT04710771|Other|alternate nostril breathing|patient inspires with one nostril at a time, right or left one by one and expires by mouth.
15768190|NCT04710758|Procedure|Laparoscopic total gastrectomy|LTG with D2 lymphadenectomy for patients with locally advanced gastric cancer (clinical stage T2-4aN0-3M0)
15768191|NCT04710758|Procedure|Open total gastrectomy|OTG with D2 lymphadenectomy for patients with locally advanced gastric cancer (clinical stage T2-4aN0-3M0)
15768192|NCT04710745|Diagnostic Test|Peripheral blood samples for routine analysis including NT-proBNP and plasmatic biomarkers.|Sampling of peripheral venous blood for analysis of plasma concentration of plasmatic markers (Apelin, microRNA, FGF-23, IGF-1, IGFBP-1) and routine analysis (laboratory parameters: NT-proBNP, D-dimer, Creatinine Clearance, CRP, Hs-troponin).
15768193|NCT04710745|Diagnostic Test|Echocardiography|"ECHO parameters:
~E/e´
~Mean e' septal and lateral wall
~LA volume (Biplane Area-Length Method)
~Left atrial volume index
~Diameter of left atrium in PLAX
~Severe aortic stenosis
~Severe mitral regurgitation
~Severe tricuspid regurgitation
~Left ventricular end-diastolic diameter
~Interventricular septum
~Posterior wall
~LV Mass
~Left ventricular mass index"
15768194|NCT04710745|Diagnostic Test|ECG Holter monitor|Patient receives an ECG Holter for a 7-day monitoring.
15768195|NCT04710745|Diagnostic Test|Standardized Mini-Mental Status Exam (SMMSE)|A screening test for evaluating cognitive performance of patients done in the clinician's office.
15768196|NCT04710732|Drug|Standard Enoxaparin 40 mg once-daily before randomization|"Once-daily subcutaneous injection of a standard prophylactic dose of Enoxaparin 40 mg according to the set schedule:
~12 hours before the surgery (if applicable) on a postoperative day -1 (POD -1)
~6-12 hours after the surgery (key injection 1) on the surgery day (POD 0)
~12 hours after the previous key injection 1 (key injection 2) on the POD 1
~24 hours after the previous key injection 2 on the POD 2"
15768197|NCT04710732|Drug|Standard Enoxaparin 40 mg once-daily after randomization|Once-daily subcutaneous injection (every 24 hours) of a standard prophylactic dose of Enoxaparin 40 mg since POD 3 and until discharge
15768198|NCT04710732|Drug|Escalated Enoxaparin 30 mg twice-daily after randomization|Twice-daily subcutaneous injection (every 12 hours) of an escalated prophylactic dose of Enoxaparin 30 mg since POD 3 and until discharge
15768199|NCT04710732|Device|Anti-embolic elastic compression stockings|Applied before or just after the surgery and used around the clock until discharge
15768200|NCT04710732|Diagnostic Test|Thrombodynamic test (TD)|"Blood sampling for TD:
~12 hours after key injection 1 (TD-12) on the POD 1
~24 hours after key injection 2 (TD-24) on the POD 2
~24 hours after each daily injection on the POD 4 (TD-4) and POD 5 (TD-5)"
15768201|NCT04710719|Drug|Triamcinolone Injection|Post surgical injection at site of keloid with TAC for 3 injections
15768202|NCT04710719|Drug|Triamcinolone Injection and 5-fluorouracil injection|Post surgical injection at site of keloid with TAC and 5FU for 3 injections
15768235|NCT04710381|Drug|IMUNOR|The intervention consists of the administration of IMUNOR as prevention against COVID-19 disease
15768207|NCT04710654|Other|Interferential current stimulation (100 Hz frequency)|The four electrodes (superficial, self-adhesive, 5x9 cm rectangular) coming out of the two channels will be used. Two of the electrodes will be placed bilaterally at the level of the spinal segment, T9-L2, where the sympathetic fibers of the gastrointestinal tract are innervated, in the posterior region, and the other two will be placed anteriorly on the umbilicus lateral to the abdomen. The current will be applied at the sensory level, increasing to the extent that the patient feels the current effectively but does not reveal pain, discomfort and visible muscle contractions. The application will be made to the individuals at 100 Hz frequency three days a week, for four weeks.
15768208|NCT04710654|Other|Interferential current stimulation (0-100 Hz frequency)|The four electrodes (superficial, self-adhesive, 5x9 cm rectangular) coming out of the two channels will be used. Two of the electrodes will be placed bilaterally at the level of the spinal segment, T9-L2, where the sympathetic fibers of the gastrointestinal tract are innervated, in the posterior region, and the other two will be placed anteriorly on the umbilicus lateral to the abdomen. The current will be applied at the sensory level, increasing to the extent that the patient feels the current effectively but does not reveal pain, discomfort and visible muscle contractions. The application will be made to the individuals at 0-100 Hz frequency three days a week, for four weeks.
15768209|NCT04710654|Other|behavioural therapy|"The behavioral therapy includes patient education (description of the disease, symptoms, risk factors, treatment, defecation mechanism and informing about negative attitudes and behaviors towards defecation), lifestyle advices (diet, water consumption, fiber food, etc.), teaching effective defecation posture, timed toilet training, self-abdominal massage.
~Constipation Behavioral Therapy Booklet will be prepared within the scope of behavioral therapy."
15768210|NCT04710654|Other|exercise program|"Exercise program consisting of physical activity, core stabilization exercises and pelvic floor muscle exercises.
~Exercise Program Booklet will be prepared within the exercise training."
15768211|NCT04710641|Drug|MTL-CEBPA|Administered over a 4 week cycle on Day, D8 and D15
15768212|NCT04710641|Drug|Sorafenib|Oral adminstration twice a day
15768213|NCT04710628|Drug|Pembrolizumab|Pembrolizumab 200 mg will be administered to patients as 30-minute intravenous infusion (a window of -5 minutes and +10 minutes is permitted) every 3 weeks.
15768214|NCT04710628|Drug|Lenvatinib 10 mg|Lenvatinib 20 mg (2 capsules of 10 mg) will be administered daily at the same time, with or without food. At the day 1 of each cycle, lenvatinib will be administered within 4 hours after finishing pembrolizumab (lenvatinib after pembrolizumab)
15768216|NCT04710602|Procedure|Minimally invasive surgical fixation of unstable rib cage|Minimally invasive and muscle sparing surgical fixation of ribs and/or sternum in an unstable segment of the chest wall (flail chest) with titan plates or medullary nails (MatrixRib Fixation System, DepuySynthes).
15768217|NCT04710602|Procedure|Large incision surgical fixation of unstable rib cage.|Surgical fixation of ribs and/or sternum in an unstable segment of the chest wall (flail chest) with titan plates or medullary nails (MatrixRib Fixation System, DepuySynthes). Large non muscle sparing incision with simultaneous thoracotomy.
15768218|NCT04710589|Radiation|CTV|According to the clinical conditions of the patients, they will be assigned to two groups based on the doctor's recommendations and their own wishes
15768220|NCT04710550|Drug|F18-3F4AP|PET Scan
15768223|NCT04710524|Drug|Placebo|Placebo BID for 13 weeks
15768224|NCT04710524|Drug|FM101 150 mg BID|FM101 (150 mg) BID for 13 weeks
15768225|NCT04710524|Drug|FM101 300 mg BID|FM101 (300 mg) BID for 13 weeks
15768226|NCT04710511|Other|Child and Youth Resilience Measure - Revised (CYRM-R)|(CYRM-R): questionnaire , answered by the child (PMK): questionnaire, answered by the parent
15768227|NCT04710498|Drug|Atezolizumab|Atezolizumab administered intravenous (IV) infusion at a fixed dose of 1200 mg
15768228|NCT04710472|Device|Mentora App|"Participants will be invited to register their treatment side effects, symptoms, daily activities and exercise and QoL on a health app designed for this purpose.
~The Mentora Health App includes a tool based on PRO-CTCAE™, a patient-reported outcome measurement system developed by the National Cancer Institute, version 1.1, that includes 80 symptoms (attachment 1) and has been translated and validated to Portuguese (Portugal) by the authoring entity. These symptoms are graded on a five-point scale from 0 (not present) to 4 (disabling) based on clinical criteria."
15768229|NCT04710459|Procedure|cryotherapy|Group 1 included 30 patients, they were subjected to chemoradiotherapy plus endobronchial cryotherapy. Group 2 included include 30 patients, they were subjected to chemoradiotherapy.
15768230|NCT04710433|Device|Non-invasive Neuromodulation|Sacral nerve stimulation via two adhesive electrodes (single current).
15768231|NCT04710433|Other|Medical and Behavioral Therapy|Behavioral Therapy consists of toilet training, an active and healthy lifestyle. Doses of medical options are applied weight-adjusted.
15768232|NCT04710420|Device|Endovascular therapy|Endovascular treatment for critical limb threatening Ischemia
15768233|NCT04710407|Drug|TBPM-PI-HBr|TBPM-PI-HBr (2 x 300mg tablets) a total of five doses
15768234|NCT04710394|Behavioral|Smell Training|Participants will be provided with 4 labeled jars, each containing an odor pre-impregnated cotton pad. Participants will sniff each scent for 10 seconds, twice daily, once in the morning and once in evening. The participant will take 30 seconds of rest between each scent. All participants will undergo this smell training regimen for 12 weeks.
15768393|NCT04709055|Other|Usual care|Pre-operative and post-operative geriatric care as per usual practice
15768236|NCT04710368|Drug|Evolocumab Injections|Administered on day 1 (the day of the first treatment) and through week 26 with a personal injector or prefilled auto injector/pens.
15768237|NCT04710355|Device|Spinal cord stimulation|Adhesion of Intellis spinal cord stimulator to the skin of the abdomen for 4 weeks for baseline recording of activity level prior to trial with spinal cord stimulation.
15768238|NCT04710342|Device|CapBuster|Evaluate the safety and effectiveness of the CapBuster System in crossing de novo or restenotic chronic total occlusions in infrapopliteal peripheral arteries.
15768239|NCT04710329|Drug|Ascorbic acid|The daily administration of 6 grams of vitamin C intravenously in 4 equal doses every 6 hours occurred and the treatment lasted 96 hours. Vials containing 1.5 gr vitamin C were placed in 100 cc 5% dextrose and infused intravenously in 30-60 minutes. Prepared serum bottles and sets are wrapped with aluminum foil in order to protect them from sunlight.
15768240|NCT04710316|Diagnostic Test|SARS-CoV-2 screening by molecular biology|SARS-CoV-2 RT-PCR in nasopharyngeal swab targeting 2 regions of the viral genome
15768241|NCT04710316|Diagnostic Test|Serological screening|Serological screening of caregivers at D0, M1, M2, M3 (anti-nucleocapsid antibodies).
15768242|NCT04710303|Biological|hAd5-S-Fusion+N-ETSD vaccine|The hAd5-S-Fusion+N-ETSD vaccine is a hAd5 [E1-, E2b-, E3-] vector-based targeting vaccine encoding the SARS-CoV-2 S and N proteins. The hAd5-S-Fusion+N-ETSD vaccine is designed to induce both humoral and cellular responses even in individuals with pre-existing adenoviral immunity.
15768243|NCT04710290|Dietary Supplement|Beta-Glucan|Solid beverage powders, capsules and placebo were randomly assigned. The main components of the solid beverage powder are beta-glucan combined with glutamine and immunoglobuin.and the main component of the capsule is beta-glucan . The main ingredient of placebo is corn starch.
15768244|NCT04710290|Dietary Supplement|Glutamine|Solid beverage powders, capsules and placebo were randomly assigned. The main components of the solid beverage powder are beta-glucan combined with glutamine and immunoglobuin.and the main component of the capsule is beta-glucan . The main ingredient of placebo is corn starch.
15768245|NCT04710290|Dietary Supplement|Immunoglobuin|Solid beverage powders, capsules and placebo were randomly assigned. The main components of the solid beverage powder are beta-glucan combined with glutamine and immunoglobuin.and the main component of the capsule is beta-glucan . The main ingredient of placebo is corn starch.
15768246|NCT04710290|Dietary Supplement|Corn starch|Solid beverage powders, capsules and placebo were randomly assigned. The main components of the solid beverage powder are beta-glucan combined with glutamine and immunoglobuin.and the main component of the capsule is beta-glucan . The main ingredient of placebo is corn starch.
15768247|NCT04710277|Other|Opioid-sparing multimodal pain management|Ice pack applied to abdominal incisions for 20 minutes every 2 to 3 hours for 24 hours after surgery and scheduled acetaminophen and NSAID for 96 hours after surgery. Narcotic pain medication for severe breakthrough pain.
15768248|NCT04710277|Other|Usual care|Scheduled acetaminophen and NSAID for 24 hours after surgery. Narcotic pain medication for severe breakthrough pain.
15768249|NCT04710264|Other|AURORA-Rec|Explorative study of cumulus cells gene expression in relation to the patient treatment and oocyte competence.
15768250|NCT04710251|Device|Speedometer|We will measure and monitor the withdrawal time of colonoscopy with a speedometer.
15768251|NCT04710225|Procedure|Upper limb fracture surgery and arterial occlusion pressure (AOP) estimation based tourniquet pressure (TP) setting|"Upper limb fracture surgery will be performed with the aid of a pneumatic tourniquet.
~The cuff (11 cm) of the tourniquet will be placed around the arm with the distal edge 5 cm above the olecranon. AOP estimation formula according to initial systolic blood pressure (SBP) and Tissue Padding Coefficient (KTP) values (AOP= [SBP+10]/KTP) from a list (Table 1) will be used to calculate AOP (17). After calculation of AOP, a safety margin of 20 mmHg will be added to AOP to determine the TP (TP=AOP+20 mm Hg). Exsanguination of the limb will be provided with an Esmarch bandage and the cuff will be inflated to the predetermined TP. TP will be manually raised in response to each 10 mmHg increase in SBP during the surgical procedure."
15768252|NCT04710212|Other|No intervention.|Observational study with no intervention.
15768255|NCT04710186|Procedure|arterial reconstructive open surgery|Patients with peripheral artery disease (PAD) will undergo arterial reconstructive open surgery. Samples obtained from diseased arteries of lower limbs of patients undergoing arterial reconstructive open surgery will be collected and immediately preserved at -80°. Briefly, arterial tissues were excised, homogenized using a motor driven homogenizer and total RNA was isolated using Trizol reagent (Invitrogen, Milan, Italy), in accordance with the manufacturer's instructions. The expression of Androgen Receptor (AR), insulin receptor (IR) and the IGF-I receptor (IGF-IR) will be quantified by real-time PCR using platform Quant Studio7 Flex Real-Time PCR System (Thermo Fisher Scientific, Milan, Italy), following the manufacturer's instructions.
15768256|NCT04710173|Procedure|ECMO|VV-ECMO
15768257|NCT04710160|Drug|Novel fast-setting calcium silicate cement (Protooth)|In form of power and liquid to be mixed together to form a paste.
15768258|NCT04710134|Biological|Reslizumab|Reslizumab 3,4, or 5 mg/kg IV q4 weeks
15768259|NCT04710121|Other|Virtual Reality Glasses|Virtual Reality Glasses (VRG), one of the methods of distracting attention; widely used in clinical medical care to relieve symptoms by providing the opportunity to create therapeutic environments for the evaluation and treatment of medical conditions. Virtual reality is a computer simulation technique that enables individuals to hear and feel the sounds and corresponding stimuli accompanying the visual image through headphones. The most basic feature that distinguishes virtual reality (VR) glasses from similar applications is that it gives individuals a real feeling. VR has helped to distract patients from mental processing and reduce the amount of pain. Virtual reality glasses, which are inexpensive to apply and use, do not cause side effects, and can be used in the recovery of the individual, are an intervention that can be preferred in nursing practices.
15768260|NCT04710108|Other|Health Communication|Spoken word poem set to video images performed by author. Comic book was transformed from the video that was equivalent in content to the video.
15768355|NCT04709341|Device|TR Band 120MIN|TR-Band is left in place for 60 minutes before it is gradually deflated by 25% at 15 minute intervals
15768356|NCT04709328|Drug|SCTA01|Diluted by 0.9% normal saline，IV
15768261|NCT04710095|Behavioral|Brief Alcohol Intervention|Brief alcohol intervention uses a motivational interviewing approach and covers the following components: giving information about the possible health risks associated with alcohol use, placing the responsibility for change on the individual, discussing the reasons for drinking and downsides of drinking, and setting a goal and change plan if the participant is receptive.
15768262|NCT04710095|Behavioral|Control Condition|The attention-matched control condition consisting of a 30-min video about astronomy.
15768263|NCT04710082|Procedure|Photorefractive keratectomy (PRK)|Photorefractive keratectomy (PRK) is a surgical procedure used by ophthalmic surgeons to treat patients presented with refractive errors and involves corneal epithelial removal followed by application of excimer laser to correct different refractive errors including Myopia, Hyperopia and Astigmatism.
15768264|NCT04710069|Behavioral|POINT|Patients randomized to the POINT program will be given preoperative counseling on adverse effects of opioids and expectations will be set that most patients do not require opioids for pain control after endocrine surgery, they will receive the info in writing afterwards as well. These patients will also be shown a short instructional video reiterating the counseling provided in the preoperative clinic visit. Information in the video will pertain to the expected pain after surgery, the over-the-counter options for pain control, the risks and side effects of using opioids, and reassurances that opioids may be prescribed at any time after discharge if pain is unmanageable. After the video, the patient will be provided with paperwork, requiring patient consent/signature to receive opioids if they opt into narcotic treatment. They will not be provided with a narcotic prescription if consent is not explicitly provided.
15768265|NCT04710056|Drug|REGN4461|
15768266|NCT04710043|Drug|BNT152|IV
15768267|NCT04710043|Drug|BNT153|intravenous (IV)
15768268|NCT04710030|Drug|Valacyclovir hydrochloride 500g caplet|Active Comparator
15768269|NCT04710030|Drug|Placebo sugar pill caplet|Placebo Comparator
15768270|NCT04710017|Drug|Tranexamic acid|will be given Tranexamic acid at 500 mg four times daily (2 g/day) during the bleeding episodes for 5 days. The dose is 250 mg.
15768271|NCT04710017|Drug|Medroxyprogesterone Acetate 150 MG/ML|will be given MPA at 150 mg once intramuscular injection
15768272|NCT04710004|Device|Asynchronous distributed multi-electrode stimulation (ADMES) using an implantable neurostimulation device|Participants will receive asynchronous pulses distributed across a multi-electrode array of 16 micro-electrodes and stimulating at low (theta) frequencies.
15768273|NCT04709991|Procedure|Endovascular procedure|Creation of a bone and arterial panorama using EndoNaut® software. The routine care procedure begins with staged injections of contrast medium to provide a map of the lesions. The lesions are then treated by angioplasty with or without stenting.
15768274|NCT04709978|Diagnostic Test|Videofluoroscopic Swallowing Study|Participants swallow different barium containing liquid and food boluses types that are captured on fluoroscopic imaging in real time.
15768275|NCT04709978|Diagnostic Test|Nuclear medicine pulmonary aspiration study|Participants will be administered radiotracer (Tc-99m-Sulfur Colloid) orally and static images of the chest will then be obtained at specified intervals over the next 2 hours to determine location of the radiotracer.
15768276|NCT04709978|Diagnostic Test|TOR-BSST and 3 oz Water Swallow|"The research specialist will conduct ten 1 tsp water swallows, one cup sip of water and a 3 ounce water swallow test with the patient. After each swallow, the participant is asked to say ah so that their voice quality can be assessed."
15768277|NCT04709978|Diagnostic Test|Sputum Culture|Patients will have sputum collected during stay
15768278|NCT04709965|Diagnostic Test|Face2Gene|This study investigates whether a new diagnostic intervention (Face2Gene facial recognition software) is better than using standard approach to diagnosis.
15768279|NCT04709952|Device|Transcranial direct current stimulation_High real|Transcranial DCS (tDCS) is applied to patients with depressive disorder taking antidepressants in high real stimulation group (2mA).
15768280|NCT04709952|Device|Transcranial direct current stimulation_Low real|Transcranial DCS (tDCS) is applied to patients with depressive disorder taking antidepressants in Low real stimulation group (1mA).
15768281|NCT04709952|Device|Transcranial direct current stimulation_Sham|Transcranial DCS (tDCS) is applied to patients with depressive disorder taking antidepressants in sham stimulation group (0mA).
15768282|NCT04709939|Other|OPAT|Observation of patients who are discharged from the hospital on OPAT.
15768283|NCT04709939|Other|Focus Group|Focus group with infectious disease physicians who prescribe OPAT to patients but were not involved in the study.
15768284|NCT04709926|Other|Survey|Paramedics will complete a 5 minute survey that is asking for their opinions on why they did or did not take part in the PRESTO training package and also why they think paramedics might not engage with research training in general.
15768285|NCT04709926|Other|Interview (optional)|Paramedics will also be given the option to participate in a 1hr interview to explore the questions asked in the survey in more detail.
15768286|NCT04709913|Drug|HU6|HU6 is designed to reduce the steatosis, inflammation, fibrosis and hepatocyte injury in Noncirrhotic Nonalcoholic Steatohepatitis (NASH)
15768287|NCT04709900|Diagnostic Test|CT angiography, FFR-CT and stress CT myocardial perfusion|The study intervention heart team consists of a specialist in Cardiac CT imaging, an invasive cardiologist, a thoracic surgeon and a cardiology nurse specialist. Treatment strategy defined by the study heart team based on CT findings involve referral for percutaneous coronary intervention, Coronary Artery Bypass surgery and/or initiation of optimal medical therapy, in addition to potential supplementary diagnostic procedures.
15768288|NCT04709887|Procedure|Wound treatment|According to the guidelines and recommendations of the International Diabetic Foot Working Group, ulcer surface debridement, negative pressure suction drainage, and routine dressing were performed until the wound healed or the end of the trial.
15768289|NCT04709887|Procedure|Vascular intervention surgery|Segmented distal angiography under the guidance of digital subtraction angiography (DSA) were perform after local anesthesia. The superficial artery is expanded by a 3-4 mm balloon.
15768351|NCT04709380|Drug|Sorafenib|Sorafenib is a multi-targeted oral drug for the treatment of cancer.Treatment of inoperable advanced renal cell carcinoma ,inoperable or distant metastatic primary hepatocellular carcinoma and so on.
15768353|NCT04709354|Diagnostic Test|Dermoscopic examination|The periungual area, nail plate, subungual area of the patients' fingernails will be examined and images of the lesional nails or target nails will be recorded for comparison.
15768290|NCT04709887|Procedure|Tibial transverse transport surgery|In the anteromedial area of the proximal tibia of the affected limb, the external fixation frame was compared with the area along the midline of the medial longitudinal axis of the proximal tibia. Subsequently, two 3.0 Steinmann pins were inserted through the single layer of cortical bone. The skin was cut along the long axis with the 3.0 Steinmann pin as the centre, and the subcutaneous tissue was separate bluntly to expose the periosteum. The Steinmann pins were used as the centre point for the drilling on four sides with a 2.0 drill bit and use of a rapid osteotomy device; the length of each side was 2.5 cm. Subperiosteal osteotomy was performed with a 5-mm narrow bone knife at an angle of 15°-30° to the bone surface. The surgeons should pay attention to protect the blood supply of the periosteum during this procedure. The external fixators were fixed with 4.0 Steinmann pins at the distal and proximal ends. The subcutaneous tissue and skin were sutured.
15768291|NCT04709874|Other|Paravertebral block|Paravertebral block using nerve stimulator guidance will be done at C7-T1
15768292|NCT04709874|Other|Suprascapular block|Paravertebral block using nerve stimulator guidance will be done
15768293|NCT04709848|Other|None - standard of care|Observational study only. Pre-screening group were not screened for Strongyloides, as per the standard of care at the time. Screened group were screened for Strongyloides, because the standard of care at our centre changed.
15768294|NCT04709835|Drug|AT-527|Results from Cohort A will determine the dose and regimen to be used for Cohort B. Cohort C, D and E dose and regimen will also be based on emerging data.
15768295|NCT04709835|Drug|Placebo|The dose and regimen of the placebo will match that of the respective AT-527 comparator arm.
15768296|NCT04709822|Behavioral|Visuospatial Interference|"Two remote intervention sessions with a researcher including a simple cognitive task (a memory cue and 25 minutes of Tetris game play with mental rotation) alongside accompanying information.
~Participants are instructed that they may continue using the technique self-guided after the first intervention session, and they may opt for additional intervention sessions with remote researcher support (maximum 6 intervention sessions)."
15768297|NCT04709809|Device|Retinal Vessel Analyzer recordings with electrocardiographic (ECG) gating|Video recordings of ocular fundus, an analysis of dynamic vessel diameters and putting them in ECG context.
15768298|NCT04709796|Drug|EmbryoGlue®, Vitrolife|The intervention under study is the application of EmbryoGlue®, a class III medical device (CE Marked). EmbryoGlue® is a bicarbonate buffered medium containing recombinant human albumin, hyaluronan and gentamicin as an antibacterial agent.
15768299|NCT04709796|Drug|Conventional Transfer|The control arm is the conventional embryo transfer without Embryo glue medium
15768300|NCT04709783|Other|3-Step Workout for Life|Participants will receive the 3-step Workout for Life program given by their physical therapy or occupational therapy providers. The program includes single-joint and multiple joint progressive resistance exercise and activities of daily living exercise training. During the resistance exercise sessions, participants will use resistance tubing to strengthen major muscle groups of the upper extremity and lower extremity. During the activities of daily living exercise, participants will practice activities of daily living that they experience difficulty. The intervention volume, duration, and frequency will be modified to enhance practicality in a home health care setting over the implementation phase. In addition to the 3-Step Workout for Life, participants may also receive other routine rehabilitation treatment determined and provided by their therapists to facilitate their functional recovery.
15768301|NCT04709770|Drug|2-liters polyethylene glycol with citrate and simethicone|Low-volume polyethylene glycol-based bowel cleansing agent for colonoscopy.
15768302|NCT04709770|Drug|4-liters polyethylene glycol with simethicone|High-volume polyethylene glycol-based bowel cleansing agent for colonoscopy.
15768303|NCT04709770|Dietary Supplement|Low-residue diet|Diet before colonoscopy.
15768304|NCT04709757|Device|Intermittent Dosing HF10 30/90|10kHz frequency spinal cord stimulation delivered at 30 seconds ON and 120 seconds OFF
15768305|NCT04709757|Device|Intermittent Dosing HF10 30/360|10kHz frequency spinal cord stimulation delivered at 30 seconds ON and 360 seconds OFF
15768306|NCT04709744|Drug|Vitamin D|Impact of serum vit D level in SLE patients with COVID-19 disease on severity of infection, duration of COVID-19 disease course, fatigue development as a complication for both SLE and COVID-19 and assess impact of prior chloroquine on COVID-19 disease outcomes
15768307|NCT04709744|Diagnostic Test|ELISA|Measure vitamin D level
15768308|NCT04709731|Drug|Ponatinib 15mg QD|Ponatinib 15 mg tablet, taken orally once daily
15768309|NCT04709731|Drug|Ponatinib 30mg QD|Ponatinib 30 mg tablet, taken orally once daily
15768310|NCT04709718|Procedure|hepatectomy|liver resection taking over the liver hemangioma
15768311|NCT04709705|Biological|Human platelets|Platelets given to control bleeding
15768312|NCT04709692|Drug|(+)-SJ000557733 (SJ733)|Anti-Malarial
15768313|NCT04709679|Procedure|MicroPulse TransScleral CycloPhotoCoagulation|A laser power of 2000- 2500 mW, a laser duration time of 50 to 80 sec per hemifield and varying da number of sweeps per hemifield 3, 4 or 5 will be randomized between patients
15768314|NCT04709666|Procedure|Endsocopic Retrograde ColangioPancreatography (ERCP)|
15768315|NCT04709653|Other|occupational-based nursing program|"First Session (Rug Weaving Activity): The child and the caregiver will be informed about the purpose and process of the research. The researcher will show in detail how to use rug weaving materials. Rug weaving activity will be started with the child. At the end of the 30-minute practice, the second session with the child will be planned and the session will be ended.
~Second Session (Rug Weaving Event Continues). Third Session (Rug Weaving Activity Continues): Rug weaving activity will be completed and the session will be ended by planning the fourth session with the child.
~Fourth Session (Origami Activity): A figure will be made with origami with the child. The child will be given support to make another figure. The fifth session hour will be planned with the child and the session will be ended.
~Fifth Session (Shape Making Activity with Chenille): A shape will be created with the child with chenille."
15768316|NCT04709653|Other|Control Group|Routine nursing care
15768352|NCT04709367|Other|3D optical scan|The clinical protocol consisted of four test sessions in four different days for an overall duration of 3 weeks. During the 1st session, amputees' residual limb volume was measured 7 times at intervals of 10 minutes after the prosthesis removal. During the subsequent sessions, the residual limb volume was measured immediately after the prosthesis doffing and after the amputee's stabilization time, before and after 15-min of walking on a treadmill, both in the morning and in the afternoon.
15768317|NCT04709640|Other|Tailored Medication Management Intervention|This research study involved an initial 1.5 hour visit and 2-3 follow up home visits (each lasting 60 minutes). Participants received 2-3 home visits during which they received recommendations on strategies which will improve medication management. Level II occupational therapy fieldwork students made the recommendations, after approval from their supervising licensed OT. The OT fieldwork students provided assistance to the individual in implementing strategies, obtaining adaptive equipment at little or no cost to the individual.
15768318|NCT04709627|Device|enFlow IV Fluid and Blood Warming System|The enFlow IV fluid/blood warming system's intended use is for warming blood, blood products and intravenous solutions prior to administration.
15768319|NCT04709601|Drug|Hiprex|Patients with negative urine culture will be prescribed Hiprex 1 g PO BID x 1 yr and patients with a positive urine culture will be prescribed antibiotics.
15768320|NCT04709588|Dietary Supplement|placebo group|subjects drank 50 ml every night for 14, 28 days
15768321|NCT04709588|Dietary Supplement|collagen drinkss|subjects drank 50 ml every night for 14, 28 days
15768322|NCT04709575|Drug|REGN5713|Administered subcutaneously
15768323|NCT04709575|Drug|REGN5714|Administered subcutaneously
15768324|NCT04709575|Drug|REGN5715|Administered subcutaneously
15768325|NCT04709575|Drug|Placebo|Placebo that replaces REGN5713-5714-5715
15768326|NCT04709562|Device|High Velocity Nasal Insufflation (HVNI)|The purpose of this intervention is to evaluate the efficacy of HVNI in clinically stabilizing patients presenting with hypercapnic respiratory distress.
15768327|NCT04709562|Device|Noninvasive Positive Pressure Ventilation (NIPPV)|The purpose of this intervention is to evaluate the efficacy of NIPPV in clinically stabilizing patients presenting with hypercapnic respiratory distress.
15768328|NCT04709549|Behavioral|Diabetes Prevention Program + Job and Legal Services|"Diabetes Prevention Program (DPP) is a one-year lifestyle modification program that helps adults at risk for developing type 2 diabetes gain tools for healthy living.
~Job readiness services will be provided by YMCA SF service connectors, trained staff with expertise in employment services who are bi-lingual in English/Spanish and/or Cantonese/English to serve the needs of the community. Service Connectors will assist with providing employment services (e.g job search, potential placement and retention services, relationship development with partners and employers) and job readiness instruction/training."
15768329|NCT04709549|Behavioral|Diabetes Prevention Program|Diabetes Prevention Program (DPP) is a one-year lifestyle modification program that helps adults at risk for developing type 2 diabetes gain tools for healthy living.
15768330|NCT04709536|Drug|IBI306|Recombinant humanized Anti- PCSK9 monoclonal antibody, administered SC from BL to week 24
15768331|NCT04709536|Drug|Placebo|Recombinant humanized Anti- PCSK9 monoclonal antibody, administered SC from BL to week 24
15768332|NCT04709523|Procedure|bovine-derived xenograft with i-PRF|Bovine-derived xenograft was mixed with i-PRF and was placed in the augmentation site.
15768333|NCT04709523|Procedure|bovine-derived xenograft alone|Bovine-derived xenograft was placed in the augmentation site.
15768334|NCT04709510|Diagnostic Test|Duplex Ultrasound|Duplex Ultrasound was performed for every participants for the diagnosis of symptomatic or asymptomatic deep vein thrombosis
15768335|NCT04709497|Procedure|viscotrabeculotomy (VT)|viscotrabeculotomy (VT)
15768336|NCT04709497|Procedure|visco-circumferential-suture-trabeculotomy (VCST) .|visco-circumferential-suture-trabeculotomy (VCST)
15768337|NCT04709497|Procedure|combined VT-Trabeculectomy with MMC (VT-Trab).|combined VT-Trabeculectomy with MMC (VT-Trab).
15768340|NCT04709471|Drug|Nicotine|Participants will reduce their nicotine intake
15768341|NCT04709471|Device|Juul e-cigarette|Participants will switch to Juul pods containing less nicotine
15768342|NCT04709471|Behavioral|Reduction|Participants will reduce the number of Juul pods that they use
15768343|NCT04709458|Biological|TBX-2400|Hematopoietic stem cells transplantation
15768344|NCT04709445|Diagnostic Test|ICG-NIRF Imaging plus ingress and egress analysis|intraoperative NIRF Imaging using the fluorescence agent ICG (indocyanine-green) before and after anastomosis formation, postoperative analysis of ingress and egress for specific regions of interest
15768345|NCT04709432|Procedure|ECMO|ECMO is a form of Extracorporeal Life Support (ECLS) to support either the pulmonary, or both the pulmonary and cardiac systems.
15768346|NCT04709419|Device|Celliant Diabetic Medical Socks|"Celliant® Diabetic Medical Socks (Celliant Socks) are intended to provide infrared radiation (IR) to increase tissue oxygen thereby increasing blood flow and circulation in the affected area leading to an effect on wound closure outcomes and possible pain reduction."
15768347|NCT04709419|Device|Control (placebo) Medical Socks|The Control Sock will be visually identical to the Active Celliant® Sock. The sock will be made of identical materials without the Celliant® components. The Control sock will be 82% standard polyester, 13% Nylon, and 5% Spandex.
15768348|NCT04709406|Drug|deep neuromuscular blockade in bariatric surgery|obese patients who underwent bariatric surgery
15768349|NCT04709393|Other|FRAX+SARC-F questionnaire pre-screening|Pre-screening group participants will receive the FRAX+SARC-F questionnaire pre-screening and be notified of the preliminary estimation of their future hip fracture risk before being invited to our DXA screening and fall-risk assessment.
15768350|NCT04709380|Other|Radiotherapy plus Toripalimab|Intensity modulated radiotherapy has shown important role in the treatment of hepatocellular carcinoma (HCC), especially for advanced disease with portal vein tumor thrombosis (PVTT), or hepatic vein tumor thrombosis. Toripalimab is a recombinant, humanized programmed death receptor-1 (PD-1) monoclonal antibody that binds to PD-1 and prevents binding of PD-1 with programmed death ligands 1 (PD-L1) and 2 (PD-L2).
15768357|NCT04709328|Other|Placebo|IV
15768358|NCT04709315|Drug|dexemedetomidine and rocuronium|In the DR group, patients received pretreatment with Dex 1 µg / kg in 10 ml 0.9% saline over 10 minutes and rocuronium 0.6 mg/kg was the intubating muscle relaxant
15768359|NCT04709315|Drug|0.9% saline and succinyl choline 1mg/ kg|0.9% saline over 10 minutes, and succinyl choline 1mg/ kg
15768360|NCT04709302|Biological|COVID-19|Patients diagnosed with a COVID-19 infection
15768361|NCT04709302|Biological|HIV|Patients diagnosed HIV-positive
15768362|NCT04709302|Drug|ART|Patients on ART
15768363|NCT04709289|Other|Aminolevulinic acid, photodynamic therapy|Aminolevulinic acid, photodynamic therapy
15768364|NCT04709276|Drug|Nivolumab|360 mg intravenously every 3 weeks
15768365|NCT04709276|Drug|Ipilimumab|1 mg/kg intravenously every 6 weeks
15768366|NCT04709276|Drug|Carboplatin|"AUC 4 mg/ml per minute intravenously every 3 weeks for up to 10 cycles.
~Subjects will also receive granulocyte-colony stimulating factor (G-CSF) therapy while receiving carboplatin."
15768367|NCT04709276|Drug|Cabazitaxel|"20 or 25 mg/m2 intravenously every 3 weeks for up to 10 cycles.
~Subjects will also take prednisone by mouth at a dose of 10 mg daily and receive granulocyte-colony stimulating factor (G-CSF) therapy while receiving cabazitaxel."
15768368|NCT04709250|Procedure|interscalene block|The patient will be put in the supine position, with the arm adducted a high-frequency linear ultrasound probe is oriented transversely across the lateral neck. When visualizing the ''stoplight sign,''15 to 30 mL of 0.25% bupivacaine will be injected
15768369|NCT04709250|Procedure|selective nerve block|"the patient will be put in the sitting position, linear 38-mm high frequency 10-12 MHz transducer will be placed first on the scapula to view of the suprascapular nerve. 5-8 mL of 0.25% bupivacaine is injected to block the SSN.
~The ultrasound probe put on the posterior aspect of the shoulder to view the circumflex artery, 10 mL of 0.25% bupivacaine this will lead to loss of sensation over the deltoid.lateral pectoral nerve block (LPNB) will be done by injecting a volume of 8 ml of a 0.25% bupivacaine The probe will be moved towards the biceps muscle until the musculocutaneous nerve is seen and 8 ml of 0.25% bupivacaine will be injected."
15768370|NCT04709250|Drug|bupivacaine|bupivacaine
15768371|NCT04709224|Drug|Lumateperone Long-Acting Injectable|Lumateperone Long-Acting Injectable
15768372|NCT04709211|Procedure|Facia Iliaca block|patients will receive Ultrasound-guided Facia Iliaca block using 50 ml 0f Bupivacaine 0.25%
15768373|NCT04709211|Procedure|Anterior Quadratus Lumbroum block|patients will receive Ultrasound-guided Anterior Quadratus Lumbroum block using 50 ml 0f Bupivacaine 0.25%
15768374|NCT04709211|Drug|bupivacaine|bupivacaine
15768375|NCT04709185|Drug|Dexamethasone 1 MG Oral Tablet|oral 1 mg dexamethasone at 23:00-24:00 the night before AVS
15768376|NCT04709185|Drug|Placebo|oral placebo at 23:00-24:00 the night before AVS
15768377|NCT04709172|Drug|Cefditoren pivoxil 400mg|Cefditoren pivoxil 400mg bid for 7 days
15768378|NCT04709159|Other|Call for Life Uganda|"Call for Life™ Uganda (C4LU) is a web-based mHealth tool that provides treatment support to patients in the form of daily or weekly pill adherence reminders, health messages, clinic appointment reminders and a remote symptom reporting service. The tool interacts with patients by text message (SMS) or using voice and tone input via keypad (Interactive Voice Response - IVR) on both analogue and smart phones.
~The tool uses CONNECT FOR LIFE technology, which is on an open source platform developed by Grameen Foundation and the University of Southern Maine with financial support from the Bill and Melinda Gates Foundation. It was supported by Janssen, the Pharmaceutical Companies of Johnson and Johnson and was released under the terms of the MOTECH open source license agreement."
15768379|NCT04709146|Diagnostic Test|Audio-Vestibular evaluation|Diagnostic evulation with audiometry, Tympanography, SVV, VHIT, VNG.
15768380|NCT04709133|Procedure|multi-ligament knee surgery|a chart review will be performed to identify patients who underwent surgical treatment for multi-ligamentous knee injuries at Assiut University Hospital performed by one of sports medicine orthopaedic surgeons at Assiut arthroscopy and sport unit.
15768381|NCT04709107|Other|Quality of life assessment - elective|"Patients will be asked to fill up both VascuQoL-6 and SF-36 questionnaires before the procedure, as well at 30-days and 1-year follow-up visit while they are sitting in the waiting room. To assess reliability and systematic shift and variation between the two assessments, elective patients will be asked to fill the VascuQoL-6 again at the admission to hospital, as well as 1 week after the 30-days follow-up vie an e-mail link for a test-retest assessment. All questionnaires will be administered on a tablet.
~During the 30-days follow-up 4 extra questions concerning patient related outcomes and occurrence of major complication will be added to the VascuQoL-6 questionnaire in the App. During every visit (preoperatively, at 30-days and 1-year follow-up) the stage of the lower limb peripheral artery disease will be noted according to the WIfI-Classification."
15768382|NCT04709107|Other|Quality of life assessment - emergent|"Patients will be asked to fill up both VascuQoL-6 and SF-36 questionnaires before the procedure, as well at 30-days and 1-year follow-up visit while they are sitting in the waiting room. All questionnaires will be administered on a tablet.
~During the 30-days follow-up 4 extra questions concerning patient related outcomes and occurrence of major complication will be added to the VascuQoL-6 questionnaire in the App. During every visit (preoperatively, at 30-days and 1-year follow-up) the stage of the lower limb peripheral artery disease will be noted according to the WIfI-Classification."
15768383|NCT04709094|Drug|Danicopan|Danicopan was dosed as 2 x 100 milligram (mg) tablets.
15768384|NCT04709094|Drug|Warfarin|Warfarin was dosed as 2 x 10 mg and 1 x 5 mg warfarin sodium tablets (Coumadin or generic equivalent).
15768385|NCT04709094|Drug|Bupropion|Bupropion was dosed as Wellbutrin (or generic equivalent) as 1 x 100 mg tablet.
15768386|NCT04709094|Drug|Ethinyl Estradiol/Norethindrone|EE/NET (0.035 mg/1 mg) was dosed as Ortho-Novum-1/35 (or generic equivalent) fixed-dose combination tablets.
15768387|NCT04709081|Drug|ACH-0145228|ACH-0145228 was dosed as 2 x 60 milligram (mg) (Part 1) or 1 x 40 mg (Part 2) powder in capsules.
15768388|NCT04709081|Drug|Midazolam|Midazolam was dosed at 2 mg (1 milliliter [mL] of a 2 mg/mL syrup).
15768389|NCT04709081|Drug|Digoxin|Digoxin was dosed as Lanoxin (or generic equivalent) at 1 x 0.25 mg tablet.
15768390|NCT04709081|Drug|Itraconazole|Itraconazole was dosed as Sporanox (or generic equivalent) at 200 mg (20 mL of a 10 mg/mL oral solution).
15768391|NCT04709068|Device|Current Health|wearable device and tablet used to collect health measures at home
15768392|NCT04709055|Other|Co-management|Personalized and intensive geriatric peri-operative care
15768394|NCT04709042|Procedure|Chordal tension measurement|"The chordal tension measurement will be performed during surgery. The neochordae are connected to the measuring device through crocodile clips (e.g. machine-patient interface).We start to apply traction on the chordae that is in the center of the flailing area thanks to a millimeter screw and under TEE control. After obtaining a stable tension (plateau value), the other chordae are then tracked, one at a time, with an individual screw. When we achieve an equivalent tension on all chordae, a traction on all chordae is applied thanks to the principal screw under TEE control until obtaining a perfect coaptation. When the correction is optimal (good echocardiographic result, chordal tension low and equally spread on each chordae), the measurements are then stopped, and the chordae are fixed at the apex of the left ventricle at the optimal length."
15768395|NCT04709042|Other|Cardiac Magnetic Resonance Imaging (MRI)|Patients will undergo 2 MRI exams: 1 MRI before surgical intervention (maximum 21 days before) and 1 MRI three months after surgery (+/- 14 days), with intravenous administration of gadolinium.
15768396|NCT04709029|Drug|Dexamethasone intravenous|Evaluation of intravenous dexamethazone in prevention of postdural puncture headache
15768397|NCT04709029|Drug|Dexamethasone intrathecal|Evaluation of intrathecal dexamethazone in prevention of postdural puncture headache
15768398|NCT04709016|Behavioral|self-questionnaire|self-questionnaire assessing Chemsex's (drug use in a sexual context) consumption over the last 12 months
15768399|NCT04709003|Diagnostic Test|Serologic test|A blood test to check antibodies type and amount
15768400|NCT04709003|Diagnostic Test|Respiratory swabs|PCR test to Covid-19
15768401|NCT04708990|Device|Delipid Extracorporeal Lipoprotein filter from Plasma|As a non-pharmacological therapy, Delipid Extracorporeal Lipoprotein filter from Plasma (DELP) hase been approved by China Food and Drug Administration to treat acute stroke
15768402|NCT04708977|Procedure|One-level lateral lumbar interbody fusion with Indirect Decompression|One-level lateral lumbar interbody fusion, with or without percutaneous posterior instrumentation. Thorough discectomy will be performed using lateral access. Fusion will then be performed using lateral access interbody cage and allograft bone graft with or without use of recombinant human bone morphogenic protein 2.
15768403|NCT04708977|Procedure|One-level lateral lumbar interbody fusion with Direct Decompression|"One-level lateral lumbar interbody fusion, with or without percutaneous posterior instrumentation. Thorough discectomy will be performed using lateral access instruments. Fusion will then be performed using lateral access interbody cage and allograft bone graft with or without use of recombinant human bone morphogenic protein 2.
~Additionally, direct decompression through midline or parasagittal approach will be utilized. A unilateral laminotomy or complete bilateral laminectomy may be performed."
15768404|NCT04708964|Drug|Flurbiprofen|Flurbiprofen solution will be administered, through the subglottic intake door of the endotracheal tube.
15768405|NCT04708964|Drug|saline solution|Saline solution will be administered, through the subglottic intake door of the endotracheal tube.
15768408|NCT04708938|Other|High voltage electrical stimulation+exercise therapy|The effect of high voltage electrical stimulation on temporomandibular disorders
15768409|NCT04708938|Other|Exercise therapy|The effect of high voltage electrical stimulation on temporomandibular disorders
15768410|NCT04708925|Other|conservative versus plasmapharesis therapy|conservative versus plasmapharesis therapy
15768411|NCT04708912|Other|Observation|The study parameters will be obtained at the time of recuirement (Basal)
15768412|NCT04708899|Behavioral|arabic version of differential processing training program|comprehensive training program for central auditory processing disorder contains auditory and linguistic tasks (language organization, phonemic and phonetic awareness, dichotic listening,temporal patterning and auditory discrimination).
15768413|NCT04708899|Behavioral|Arabic computer based auditory traing program(CBAT)|comprehensive computer based traing program for central auditory processing disorder contains auditory memory, temporal processing, dichotic listening , selective attention and phonemic awareness games.
15768414|NCT04708886|Drug|Romosozumab|Year 1 study drug
15768415|NCT04708886|Drug|Alendronate|Year 2 study drug
15768416|NCT04708873|Other|High intensity interval training|4x4 min intervals of high intensity treadmill running (80-95% of HRR, RPE 7-10 on Borg's category ratio scale of perceived exertion) interspersed with active recovery (slow jogging or fast walking at 50-70% HRR). HIIT-Resistance exercises 2 sessions per week, RPE 5 (hard) 6-8 RM, 1-3 sets of as many repetitions as possible in 60 seconds, active recovery 20-60 seconds b/w exercises,
15768417|NCT04708873|Other|Moderate Intensity Continuous Training|Moderate intensity continuous Aerobic exercises (Stationary cycling for 15-20 min followed by treadmill walking for 15-20 min) at 55-70% 55-70% of HRR, RPE 3-4 on Borg's category ratio scale of perceived exertion. The session will be preceded by 5-7 minute warm-up &amp; 7-10 min cool-down.
15768418|NCT04708860|Behavioral|Prolonged Nightly Fasting|Restriction of consumption of calorie-containing food/drinks after 8pm
15768419|NCT04708860|Behavioral|Exercise|Personalized moderate-intensity, aerobic exercise and strength training
15768420|NCT04708847|Drug|GYM329|GYM329 subcutaneous injection
15768421|NCT04708847|Drug|Placebo|Placebo subcutaneous injection
15768422|NCT04708834|Drug|Troriluzole (BHV-4157)|200 mg daily first 2 weeks, 280 daily for following 46 weeks
15768423|NCT04708821|Drug|Dexamethasone ophthalmic insert 0.4Mg|Dextenza 0.4Mg Ophthalmic Insert
15768424|NCT04708821|Drug|0.2% loteprednol etabonate ophthalmic suspension|0.2% loteprednol etabonate ophthalmic suspension
15768425|NCT04708821|Drug|olopatadine hydrochloride ophthalmic solution 0.7%|olopatadine hydrochloride ophthalmic solution 0.7%
15768426|NCT04708808|Behavioral|music therapy|cases will randomly assigned to receive music therapy group with routine care, plus music given via headphone, or assign to control group with no music given.
15768427|NCT04708795|Drug|AP701|Preparation of Cannabis flowers (Cannabis flos)
15768428|NCT04708782|Drug|Placebo|Placebo administered QID
15768429|NCT04708782|Drug|Inhaled Treprostinil|Inhaled treprostinil (6 mcg/breath) administered QID
15768430|NCT04708782|Device|Treprostinil Ultrasonic Nebulizer|Treprostinil ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath.
15768431|NCT04708769|Behavioral|Smartphone App Participants (APP)|Participants will receive calorie, fat, and physical activity goals, a Smartphone application for self-monitoring their diet, activity and weight, online educational readings, and brief bi-weekly remote health sessions with a Health Promotionist. They will also be provided with a wireless bluetooth scale and portable blood pressure machine.
15768432|NCT04708769|Behavioral|Diabetes Prevention Program Participants (DPP)|In accordance with the Center for Disease Control curriculum, participants will receive a participant log for tracking physical activity, food intake, and weight, a paper participant guide with worksheets, logs, and psycho-educational materials, and 16 hour long remote sessions with a Health Promotionist. They will also be provided with a wireless bluetooth scale and portable blood pressure machine.
15768433|NCT04708756|Behavioral|Collabree Mobile Phone Application Medication Adherence Booster (simplified version)|Patients take part in a 90-day program to promote medication adherence and a 90-day follow-up through the Collabree application. Patients will receive more information as to the exact functions and use of the mobile phone application when the application is installed on their mobile phone. Patients will receive standard care.
15768434|NCT04708756|Behavioral|Collabree Mobile Phone Application Medication Adherence Booster|Patients take part in a 90-day program to promote medication adherence and a 90-day follow-up through the Collabree application. Patients will receive more information as to the exact functions and use of the mobile phone application when the application is installed on their mobile phone. Patients will receive standard care.
15768435|NCT04708743|Diagnostic Test|Automatic Tongue Diagnosis System|tongue image capture tongue images by Automatic Tongue Diagnosis System
15768436|NCT04708730|Device|Delipid Extracorporeal Lipoprotein filter from Plasma|As a non-pharmacological therapy, Delipid Extracorporeal Lipoprotein filter from Plasma (DELP) hase been approved by China Food and Drug Administration to treat acute stroke
15768437|NCT04708717|Behavioral|Stimulation Rate|Psychophysical training listening to stimulation rate as a cue for auditory pitch perception. The intervention is the listening rehabilitative exercises. Exercises are completed daily as 30-minute sessions for 2 weeks.
15768438|NCT04708717|Behavioral|Electrode Location|Psychophysical training listening to electrode location as a cue for auditory pitch perception. The intervention is the listening rehabilitative exercises. Exercises are completed daily as 30-minute sessions for 2 weeks.
15768442|NCT04708691|Other|Aerobic exercise|aerobic exercise
15768443|NCT04708652|Other|No intervention|No intervention
15768444|NCT04708639|Drug|Alectinib|Use of ctDNA to establish response and resistance to alectinib.
15768445|NCT04708626|Other|Description and analysis|Collection of clinical, laboratory and radiological data from medical records.
15768446|NCT04708626|Other|Description and analysis|Collection of laboratory data.
15768447|NCT04708613|Diagnostic Test|Cognitive/Neuropsychological Testing|Comprehensive testing of cognitive function and brain health.
15768448|NCT04708613|Diagnostic Test|Vestibular/Ocular-Motor Testing|A series of tests and questionnaires that asses vestibular function, balance, ocular-motor coordination, and reflexes.
15768449|NCT04708613|Diagnostic Test|Sleep Evaluation|A full assessment of sleep health, including insomnia (duration, frequency, daytime consequences) and other sleep disorders such as obstructive sleep apnea. Overnight sleep study is included.
15768450|NCT04708613|Diagnostic Test|MRI, High-Resolution|A high-resolution MRI to provide qualitative and quantitative assessments of brain structure.
15768451|NCT04708613|Diagnostic Test|Health & Physical Exam|Participants will undergo an executive history and physical exam of all body systems.
15768452|NCT04708613|Diagnostic Test|Physical Function|These assessments will involve a series of tests and questionnaires that focus on physical function.
15768453|NCT04708613|Diagnostic Test|Blood Testing and Biomarker Analysis|"A blood draw will be performed to measure standard clinical labs as part of a full history and physical, as well as additional analysis of biomarkers indicative of brain health.
~An optional lumbar puncture will be performed and CSF samples (20-30 mL) stored in the NCTC Biorepository until shipment to the CLIA-certified laboratory.
~Both CSF and blood samples will be analyzed for t-tau, p-tau, and Aβ42 and stored for future testing,"
15768454|NCT04708613|Diagnostic Test|Applanation Tonometry|Hearth health is evaluated through testing of arterial stiffness and pulse wave reflections using a high fidelity applanation tonometer.
15768455|NCT04708613|Diagnostic Test|PET brain imaging|PET imaging of the brain using tau and amyloid ligands.
15768456|NCT04708613|Drug|[C-11]6-OH-BTA-1|PET imaging of the brain using an amyloid ligand.
15768457|NCT04708613|Drug|[F-18]AV-1451|PET imaging of the brain using a tau ligand.
15768458|NCT04708600|Behavioral|Pitch Elevation Therapy|"Goal: mean fundamental frequency of 180Hz (range 140 and 300Hz); Doses and duration: 5 one hour sessions (5h), 5 weeks
~Content:
~auditory discrimination of lower and higher tones
~pitch glides
~pitch glides using straw phonation and resonance tube phonation
~practice of higher pitch voice (target: 180Hz) in isolated vowels - syllables - mono and bisyllabic words -phrases - sentences and texts - conversation (generalization to spontaneous speech)"
15768459|NCT04708600|Behavioral|Articulation Resonance Therapy|"Goal: increase in lipspreading, forward tongue carriage, larynx elevation, forward resonance, precise articulation; 5 sessions Doses and duration: 5 one hour sessions (5h), 5 weeks
~Content:
~auditory and visual discrimination of forward vs backed tongue carriage and lip spreading vs lip rounding)
~practice of technique on isolated vowels -syllables -mono and bisyllabic words - phrases - sentences and texts - conversation (generalization to spontaneous speech)
~practising larynx elevation through the twang technique, isolated vowels -syllables -mono and bisyllabic words - phrases - sentences and texts - conversation (generalization to spontaneous speech)
~forward resonance, focusing on oral forward resonance rather than chest resonance, isolated vowels -syllables -mono and bisyllabic words - phrases - sentences and texts - conversation (generalization to spontaneous speech)
~clear, precise articulation and cork exercise"
15768460|NCT04708600|Behavioral|Sham therapy|"Goal: active sham treatment, 4 sessions Doses and duration: 4 one hour and 15 minutes sessions (5h), 4 weeks
~Content:
~providing information about vocal function, vocal surgery, vocal hygiene, transgender health care
~discussing communication aspects and patterns, possible exercise contexts, communication partners, expectations of voice modification, conversational subjects
~active intervention on nonverbal communication (Kinesics, gestures and sign language, facial expression, haptics, proxemics, occulsics, and physical appearance)
~practising costo abdominal breathing patterns"
15768461|NCT04708587|Drug|dual anti-platelet therapy at least 6 months|Patients enrolled in dual antiplatelets at least 6 months arm would be administered with aspirin 100mg plus clopidogrel 75mg or prasugrel 10mg once daily for at least 6 months after randomization. Clopidogrel or prasugrel should be maintained after 6 months.
15768462|NCT04708587|Drug|dual anti-platelet therapy 3months or less|Patient enrolled in the dual antiplatelet therapy less than 3 months arm would be administered with aspirin 100mg plus clopidogrel 75mg or prasugrel 10mg once daily for less than 3 months after randomization. After 3 months clopidogrel or prasugrel should be maintained.
15768463|NCT04708574|Behavioral|Lifestyle intervention|
15768464|NCT04708574|Other|Placebo - Control|
15768465|NCT04708561|Behavioral|Speech and language therapy|"The intervention focuses on understanding the thoughts of the characters. Twenty written stories will be used, which end with statements that can be interpreted literally, ironically, as a lie, a request or a faux-pas (maladroitness). At the end of each story, the participant should explain what the characters want to mean by their statement.
~To help the participant in his understanding of the character's intention, he will be asked:
~1) To mention as many intentions as possible that can be associated with the target statement presented out of context (eg: it's hot here that can be interpreted literally, ironically, as a lie or a request) and to imagine contexts in connection with interpretation; 2. Analyze the relevant elements of the context (environment, the relationship between the characters, knowledge of the characters); 3. To judge the probability of the possible interpretations (pt 1) by justifying using the elements of the context analyzed previously (pt 2)."
15768466|NCT04708548|Other|Health-related Quality of Life|Health-related quality of life (HRQOL) is an individual's or a group's perceived physical and mental health over time.
15768467|NCT04708548|Other|Psychological Distress|Measured of the distress experienced by patients
15768468|NCT04708548|Other|Fatigue|Measure of the extreme tiredness resulting from mental or physical exertion or illness
15768469|NCT04708548|Other|Cognitive Functioning|Cognitive functioning refers to multiple mental abilities, including learning, thinking, reasoning, remembering, problem solving, decision making, and attention. This will be measured through self-report and cognitive testing.
15768470|NCT04708522|Behavioral|Breath Control - Equal Breathing Technique|The equal breathing (EB) exercise also known as square or box breathing will follow the four-part breathing cycle of inhalation, hold, exhalation, hold, repeat. Each part of the cycle will be a 4 second count repeated for 20 minutes.
15768471|NCT04708522|Behavioral|Guided Mindfulness Exercise|The guided seated mindfulness (GSM) exercise will lead the participant through a 20 minute mindfulness meditation exercise using an audio recording.
15768472|NCT04708522|Behavioral|Control|The control intervention will utilize a sham exercise. The participant will be asked to rest in a comfortable seated position for the duration of the 20 minute session.
15768473|NCT04708509|Device|Extubation Advisor|Participants undergoing a Spontaneous Breathing Trial (SBT) to assess readiness for extubation will be connected to a portable monitor displaying ECG, capnography, and other waveforms. This monitor will also be connected to a laptop containing the Extubation Advisor (EA) software. During the SBT, relevant patient information will be entered into the EA application and the EA application will record waveform data. When the SBT is complete, the EA application will analyze the waveform and patient data to generate a score summarizing the risk of extubation failure. A report will be generated and provided to the respiratory therapist and attending physician to help determine whether to proceed with extubation or not. Patients will be followed for 72 hours after extubation, when the clinical outcome case report form will be completed.
15768474|NCT04708496|Drug|Artemether-lumefantrine|"A three-arm single blind Randomized Clinical Trial in which HIV-malaria co-infected individuals with uncomplicated malaria receiving efavirenz-based ART will be randomized to one of three arms; a standard dose of artemether-lumefantrine, or a double dose of artemether-lumefantrine, or a 5-day course of artemether-lumefantrine for treatment of uncomplicated malaria. Participants will be followed up for 42 days to determine safety, drug pharmacokinetics and malaria treatment outcomes.
~The 4th objective focuses on the interaction between Dolutegravir and Artemether Lumefantrine hence this will be a single blind pharmacokinetic trial among HIV-malaria co-infected individuals receiving Dolutegravir based ART and standard dose of artemether-lumefantrine for treatment of uncomplicated malaria."
15768475|NCT04708483|Device|Extra DCE-CT scan|DCE-CT of thoracic tumors as an early biomarker for treatment monitoring in comparison with morphologic criteria.
15768479|NCT04708457|Other|VV-ECMO|Early use of VV-ECMO in SARI patients.
15768480|NCT04708444|Diagnostic Test|CD318|Flowcytometric marker
15768484|NCT04708405|Other|Observation|Follow up and observe under standard of care given
15768485|NCT04708392|Device|Spinal Cord Stimulator|A spinal cord stimulator is a surgically implanted device that delivers an electrical signal to a patient's spinal cord to reduce the perception of pain
15768486|NCT04708379|Behavioral|Lifestyle intervention|Nutrition and physical activity education.
15768487|NCT04708366|Drug|NER1006|Patients will be randomly assigned (1:1:1) to receive 1L PEG (PLENVU; Norgine, Amsterdam, Netherlands), administered as a 2-day evening/morning split-dosing, or the 2L PEG + ascorbate preparation (2LPEG - MOVIPREP; Norgine), or the 4L PEG (SELG-ESSE; Alfasigma Bologna, Italy), both administered as a 2-day evening/morning split-dosing regimen.
15768488|NCT04708366|Drug|MoviPrep|Patients will be randomly assigned (1:1:1) to receive 1L PEG (PLENVU; Norgine, Amsterdam, Netherlands), administered as a 2-day evening/morning split-dosing, or the 2L PEG + ascorbate preparation (2LPEG - MOVIPREP; Norgine), or the 4L PEG (SELG-ESSE; Alfasigma Bologna, Italy), both administered as a 2-day evening/morning split-dosing regimen.
15768489|NCT04708366|Drug|Macrogol 400|Patients will be randomly assigned (1:1:1) to receive 1L PEG (PLENVU; Norgine, Amsterdam, Netherlands), administered as a 2-day evening/morning split-dosing, or the 2L PEG + ascorbate preparation (2LPEG - MOVIPREP; Norgine), or the 4L PEG (SELG-ESSE; Alfasigma Bologna, Italy), both administered as a 2-day evening/morning split-dosing regimen.
15768490|NCT04708353|Drug|placebo capsule (vitamin c)|the patient will receive one placebo capsule (vitamin c) once one hour before the operation
15768491|NCT04708353|Drug|Group pregabalin 150|the patient will receive one capsule of pregabalin 150 mg once one hour before the operation
15768492|NCT04708353|Drug|Group pregabalin 300|the patient will receive one capsule of pregabalin 300 mg once one hour before the operation
15768493|NCT04708340|Drug|Rejuveinix (RJX) Active Comparator|Active drug comprised of: ascorbic acid, magnesium sulfate heptahydrate, cyanocobalamin, thiamine, riboflavin 5' phosphate, niacinamide, pyridoxine, calcium d-pantothenate, and sodium bicarbonate.
15768494|NCT04708340|Drug|Placebo Comparator|0.9% Sodium Chloride in Water for Injection a.k.a. Normal Saline for injection
15768495|NCT04708327|Drug|Naltrexone Hydrochloride|naltrexone hydrochloride capsules 4.5 mg each
15768496|NCT04708314|Drug|Golodirsen 50 MG/1 ML Intravenous Solution [VYONDYS 53]|Vyondys 53
15768498|NCT04708288|Device|ARCHIMEDES Biodegradable Biliary and Pancreatic Stent|Pts that will receive ARCHIMEDES Biodegradable Biliary and Pancreatic Stent
15768499|NCT04708275|Procedure|PaCT|Manualized Psychoanalytic short-term therapy (PaCT) for children with internalizing disorders, 20-25 sessions (1, 2). PaCT helps the child to resolve rigid conflictual internal representations/ working models by using interpretative and mentalizing techniques and drawing on therapeutic transference relationship with the child and the parent.
15768500|NCT04708262|Other|Cognitive Analytic Therapy for Containing Self-Harm in Young People|The intervention will run over five sessions, each lasting around 30 - 40 minutes. Researchers will follow the CATCH-Y manualised treatment guide. CATCH-Y is a brief, five session psychological intervention based upon CAT principles and designed to help young people who have self-injured.
15768501|NCT04708249|Dietary Supplement|D-chiroinositol|Supplementation with 600 mg of D-chiroinositol, two-times daily on an empty stomach, for 30 days.
15768502|NCT04708236|Drug|ORTD-1 low dose|ORTD-1 will be administered intravenously once daily for 5 consecutive days.
15768503|NCT04708236|Drug|ORTD-1 mid dose|ORTD-1 will be administered intravenously once daily for 5 consecutive days.
15768504|NCT04708236|Drug|ORTD-1 high dose|ORTD-1 will be administered intravenously once daily for 5 consecutive days.
15768505|NCT04708236|Other|Vehicle control|Vehicle Control will be administered intravenously once daily for 5 consecutive days.
15768506|NCT04708223|Device|Direct restorative treatment with fast-curing composites (Tetric PowerFill/ Tetric PowerFlow)|Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric PowerFill/ Tetric PowerFlow (test group) was cured for 3 s.
15768507|NCT04708223|Device|Direct restorative treatment with conventionally applied composites (Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill)|Tooth (teeth) affected by dental caries or with an existing defective filling will be restored. Adhese Universal in self-etch mode, was used to prepare the surfaces for the composite fillings. Tetric EvoCeram Bulk Fill/ Tetric EvoFlow Bulk Fill (control group) were conventionally cured for 10 s per increment.
15768508|NCT04708210|Drug|IBI319|Iv infusion day 1 of every 14 or 21 days in Phase Ia until disease progression or loss of clinical benefit.
15768509|NCT04708197|Device|rTMS (repetitive transcranial magnetic stimulation )|applying high frequency TMS over the damaged hemisphere in chronic post stroke aphasic patients
15768510|NCT04708184|Drug|GLPG3970 oral solution|GLPG3970 for oral administration
15768511|NCT04708184|Drug|GLPG3970 tablet|GLPG3970 for oral administration
15835191|NCT04163263|Drug|BOS-356|topical gel
15768512|NCT04708171|Procedure|Awake mapping under local anesthesia|During an awake craniotomy, the patient is awake and cooperative during the resection of the tumor while the surgeon uses electro(sub)cortical mapping to prevent damage to eloquent areas.
15768513|NCT04708171|Procedure|Asleep mapping under general anesthesia|During asleep mapping under general anesthesia, the surgeon uses electro(sub)cortical mapping with evoked potentials (MEPs, SSEPs or continuous dynamic mapping) to prevent damage to eloquent areas.
15768514|NCT04708171|Procedure|Resection under general anesthesia without mapping|During resection under general anesthesia without mapping, the surgeon does not use any intraoperative stimulation mapping techniques to identify eloquent areas.
15768515|NCT04708158|Biological|Novaferon|a novel recombinant antiviral protein drug
15768516|NCT04708158|Biological|Placebo|Saline
15768517|NCT04708145|Drug|Aflibercept Injection|Intravitreal 2mg aflibercept injection
15768518|NCT04708132|Procedure|Screw retained restoration|Hybrid prosthesis
15768519|NCT04708132|Procedure|implant-retained ball overdentures|Removable prosthesis
15768520|NCT04708119|Procedure|The follicular tissues were also excised after tooth extraction.|The follicular tissues were also excised after tooth extraction. Soft tissue samples taken during surgical removal of ILTM were evaluated in the department of pathology.
15768521|NCT04708106|Other|RELX ENDS Tobacco Flavor|Ad libitum use of the RELX ENDS Tobacco Flavor product
15768522|NCT04708106|Other|RELX ENDS Menthol Flavor|Ad libitum use of the RELX ENDS Menthol product
15768523|NCT04708106|Other|RELX ENDS Tobacco and Menthol Flavors|Ad libitum use of the RELX ENDS Tobacco and Menthol Flavor products
15768524|NCT04708093|Device|whole body vibration training|Oscillating platform
15768525|NCT04708080|Procedure|thoracic epidural analgesia|A thoracic epidural catheter is routinely placed in patients undergoing open heart surgery in our hospital, at least 1 hour before heparin administration during the operation. After standard monitoring (ECG, SpO2, NIBP) is applied to the patients in the operating room, sedoanalgesia is provided with 1-3mg of midazolam and 50-100mcg of fentanyl. Then, by providing sterilization conditions, an epidural catheter is inserted through the T5-T6 interval with Tuohy needle. After confirming the location of the epidural catheter, 25mg / 10ml bupivacaine is administered as a bolus and then 3ml / hour bupivacaine infusion is started from the solution prepared as 3mg / ml and continues until the 48th postoperative hour. On the postoperative 2nd day, the catheter is removed 10-12 hours after LMWH administration and 2-4 hours after UFH, as recommended by the guidelines, paying attention to the anticoagulant administration times applied to the patients.
15768529|NCT04708054|Drug|Busulfan|Given IV
15768530|NCT04708054|Drug|Cladribine|Given IV
15768531|NCT04708054|Drug|Fludarabine Phosphate|Given IV
15768532|NCT04708054|Procedure|Hematopoietic Cell Transplantation|Undergo stem cell transplantation
15768533|NCT04708054|Drug|Thiotepa|Given IV
15768534|NCT04708054|Drug|Venetoclax|Given PO
15768536|NCT04708015|Other|No Intervention|A retrospective chart review of medical records
15768537|NCT04708002|Other|early integrated palliative approach model|From the construction of a common vision of palliative care between actors inside and outside the nursing home to the sustainability of palliative care in nursing home.
15768538|NCT04707989|Other|Ketone- Promoting Food Ingredient #1|Novel proprietary food ingredient (#1) that contains precursors to naturally occurring energy molecules called ketone bodies. Promotes mildly elevated blood ketone concentrations. Mixed into a beverage.
15768539|NCT04707989|Other|Ketone- Promoting Food Ingredient #2|Previously characterized proprietary food ingredient (#2) that contains precursors to naturally occurring energy molecules called ketone bodies. Promotes mildly elevated blood ketone concentrations. Mixed into a beverage.
15768540|NCT04707989|Other|Ketone Free Placebo|Beverage that is matched to ketone-promoting food ingredient #1 beverage for appearance, taste, texture and volume. Does not contain ketones or ketone precursors.
15768541|NCT04707976|Device|Navina Smart|CE-marked NavinaTM Smart including Navina Smart App.
15768542|NCT04707976|Other|Standard Bowel Care|Bowel care will be scheduled at least every 2nd day according to a defined study specific standard bowel care protocol. Diet, fluids, abdominal massage, regular physical activity and medications will be used if non-interventional treatment is insufficient.
15768543|NCT04707963|Dietary Supplement|Peanut protein powder|Peanut protein powder will be provided to participants who will be instructed to consume 72g daily, mixed with water
15768544|NCT04707963|Behavioral|Full body resistance training|Participants will undergo supervised resistance training two times per week (5 exercises, 3 sets of 8-12 repetitions per set)
15768545|NCT04707950|Drug|Tranexamic Acid 100 milligram/Milliliter|"Participants will be divided into two groups: a study group & a control group. In addition to the standard management, the study group will be given TXA 1 gm (100 mg/ml) slowly intravenous infusion during delivery after clamping of the cord (administered over 10 minutes at 1 ml/minute).
~The second dose of TXA 1 g Intravenous can be given if:
~Bleeding continues after 30 minutes
~Bleeding restarts within 24 hours of completing the first dose While the control group will not be given TXA and we will compare the results in both groups (amount of blood loss during operation to assess the efficacy of TXA in the prevention of PPH and reduction of intraoperative and postoperative blood loss and to assess its safety and benefit in the reduction of incidence of hysterectomy or blood transfusion requirements)."
15768546|NCT04707950|Drug|Oxytocin|both groups will be given oxytocin as a standard management
15768547|NCT04707937|Other|Online education|Access to online modules about brachytherapy education in addition to receiving regular standard of care education
15768548|NCT04707937|Other|Regular standard of care education|Access only to regular standard of care education
15768549|NCT04707924|Device|Er:YAG laser|Treatment of scars with fractional Er:YAG 2940nm laser.
15768550|NCT04707911|Behavioral|Social Media Intervention|Social media based intervention using Instagram with up to 3 posts per day for 30 days
15768551|NCT04707898|Device|Single Bond Universal|Adhesive system
15768552|NCT04707898|Device|G-Premio Bond|Adhesive system
15768557|NCT04707859|Diagnostic Test|Head to head comparison: Rubidium vs 15O-water PET|Head to head comparison with invasive FFR as reference. Adjustment for abnormal microcirculation
15768558|NCT04707846|Device|Bright Blue Light Commercial AYO Light Therapy Device|"AYO light therapy glasses are a commercially available device which have 4 Light-emitting diodes (LEDs) with a dominant wavelength of approximately 470nm ± 2nm and typical irradiance (100% intensity) of approximately 250 µW/cm². AYO bright light glasses are classified as exempt for photo-biological risk based on the international standard and conformity assessment for photo-biological safety of lamps (IEC 62471)."
15768559|NCT04707846|Device|Dim Blue Light Commercial AYO Light Therapy Device|"AYO light therapy glasses were made available to the research team by the vendor. The device has 4 Light-emitting diodes (LEDs) with a dominant wavelength of approximately 470nm ± 2nm and reduced irradiance (1% intensity) of approximately 250 µW/cm². AYO dim light glasses are classified as exempt for photo-biological risk based on the international standard and conformity assessment for photo-biological safety of lamps (IEC 62471)."
15768560|NCT04707833|Diagnostic Test|Serological testing for COVID-19 infection|"The tests used will be the following:
~EUROIMMUN SARS-CoV-2(IgA) ELISA ELISA SARS-CoV-2 (IgG) EUROIMMUN WANTAI SARS-CoV-2 Ab ELISA WANTAI SARS-CoV-2 IgM ELISA Abbott Architect SARS-CoV-2 IgG Diasorin SARS LINK CoV-2 S1/S2 IgG Roche ECL anti-SARS-Cov-2 (combined IgG IgM IgA)"
15768561|NCT04707820|Diagnostic Test|ELISPOT|"The evolution of the number of gamma interferon (IFN) producing T lymphocytes in response to Spike glycoprotein (Spike glycoprotein) will be assessed by enumeration in ELISPOT method at 4 measurement times: D0 (confirmation of infection by PCR), D+7, D+14 or at hospital departure (D+Departure) and D+56±14 days.
~The ELISPOT method consists in stimulating peripheral blood mononuclear cells (isolated by density gradient and containing a known CD3+ T lymphocyte count) over a short period of time (16 to 20 hours) with a pool of 15 amino acid peptides (overlapping on 11 amino acids) representative of the S protein."
15768562|NCT04707807|Diagnostic Test|IIEF-5|IIEF-15 form will be filled out by all participants
15768563|NCT04707794|Drug|Sevoflurane|Sevoflurane delivery will will be titrated to maintain anaesthesia depth of 50 (BIS score) using bispectral (BIS) index monitioring
15768564|NCT04707794|Drug|Desflurane|Desflurane delivery will be titrated to maintain anaesthesia depth of 50 (BIS score) using bispectral (BIS) index monitioring
15768565|NCT04707781|Diagnostic Test|chest CT|assessment of interstitial lung disease using chest CT
15768566|NCT04707768|Drug|Vadadustat|oral tablets
15768567|NCT04707768|Drug|Mircera®|intravenous administration
15768568|NCT04707755|Other|Motor imagery technique|"The patient will sit on chair in a quiet room. The patients will be observing motor performance in video, motor performance video will consist of (1) knee flexion and extension movement, (2) sitting to standing movement, (3) stepping movement, (4) walking, (5) climbing and descending stairs.
~Addition to motor imagery, the patients will be provided the passive stretching, ROM exercises, sitting to standing, anteroposterior step, climbing and descending stairs."
15768569|NCT04707755|Other|Conventional Physical Therapy|It includes passive stretching, ROM exercises, sitting to standing, anteroposterior step, climbing and descending stairs.
15768570|NCT04707742|Drug|Betadine© bucal 100 mg/ml|15 ml 2% povidone-iodine, one minute rinse.
15768571|NCT04707742|Drug|Oximen® 3%|15 ml 1% hydrogen peroxide, one minute rinse.
15768572|NCT04707742|Drug|Clorhexidine Dental PHB©|15 ml 0,12% clorhexidine, one minute rinse.
15768573|NCT04707742|Drug|Vitis Xtra Forte©|15 ml 0,07% cetylpyridinium chloride, one minute rinse.
15768574|NCT04707742|Drug|Distilled Water|15 ml distilled water, one minute rinse.
15768575|NCT04707729|Diagnostic Test|ROX index algorithm|"The thresholds of the ROX index for intubation are the following:
~After 2 hours of HFNC: ROX <2.85.
~After 4 and 6 hours of HFNC: ROX <3.47
~After 8, 10 and 12 hours of HFNC: ROX <3.85 If the ROX index is between the abovementioned thresholds and 4.88, the NHF support will be also increased to the maximum tolerated flow (up to 60L/min) and FIO2 of 1 and subsequently titrated with the target SpO2. If the patient is already treated with to 60L/min) and FIO2 of 1 and no further increase could be done and the ROX index will be recalculated after 30 minutes of full NHF support. The ROX index will be recalculated in 30 minutes: 1) if the ΔROX is <0 the patient will be intubated; 2) if the ΔROX is 0-0.5, the ΔROX will be reassessed in 20 minutes; and 3) if the ΔROX is >0.5 the patient will not be intubated, NHF will be managed as protocolized and respiratory condition will be reassessed every two hours or at any new clinical deterioration."
15768576|NCT04707716|Other|conometric concept Acuris system|implant crown retention type using friction only
15768577|NCT04707716|Other|screw retention|screw retained implant crown
15768578|NCT04707716|Other|cementation|cement retained implant crown
15768579|NCT04707703|Drug|Isavuconazonium Injection [Cresemba]|Intravenous isavuconazonium sulfate 372 mg every 8 hours for 6 doses followed by intravenous isavuconazonium sulfate 372 mg once daily for up to 28 days
15768580|NCT04707703|Drug|Placebo|Intravenous placebo every 8 hours for 6 doses followed by intravenous placebo once daily for up to 28 days
15768581|NCT04707690|Device|Intraurethral laser therapy|The laser will be applied according to the manufacturer's protocol. This includes a 2 step laser treatment using 2 different modes at 2 timepoints. The treatment takes about 15 minutes time.
15768582|NCT04707690|Device|Intraurethral SHAM laser therapy|The laser will be applied according to the manufacturer's protocol. This includes a 2 step laser treatment using 2 different modes at 2 timepoints. The treatment takes about 15 minutes time.
15768583|NCT04707677|Device|Titanium and ceramic dental Implants|Two types of implant placement and follow-up to compare the esthetic, clinical and radiographic parameters between them.
15768586|NCT04707651|Dietary Supplement|Formula diet|Formula diet for 12 weeks
15768587|NCT04707638|Other|No intervention used|No intervention used
15768588|NCT04707625|Drug|Aflibercept Ophthalmic|Anti-vascular endothelial growth factor intraocular injection
15768589|NCT04707612|Other|No intervention.|No intervention.
15768590|NCT04707599|Other|Reminder plus (telephone call from therapist)|Reminder plus (telephone call from therapist)
15768591|NCT04707586|Other|Cold Application|Created by the researcher; A bandage with 3 pieces of 13x10 cm cold gel and a cold gel container in which they are placed will be used, which can be adjusted according to the head circumference of the patient between 60-80 cm in length. The ability of the cold gel cups of the bandage to be moved on the bandage will allow comfortable cold application to the patient's bilateral frontotemporal and occipital areas at the same time. After waiting for 20 minutes in the freezer part of the refrigerator, the temperature and temperature of the gels applied and the cold application area before and after each application will be measured and recorded. An Infrared Non-Contact Food Thermometer will be used for temperature measurement of cold gel packs, and an Infrared Non-Contact Thermometer device will be used for temperature measurement of the cold application area.
15768592|NCT04707573|Drug|vadadustat|oral capsules
15768593|NCT04707560|Procedure|EUS fine needle biopsy with heparin wet suction|"EUS FNB with Heparin wet suction:
~Investigator will remove stylet from the FNB device and then infuse Heparin 1ml (5000IU) into device before procedure. The syringe will pre-loaded with 10 ml negative pressure and attach to device upon needle tip insertion into mass lesion.
~EUS FNB with Dry suction:
~Investigator will remove stylet from the FNB device. Syringe will be pre-loaded with 10 ml negative pressure in syringe and attach to needle tail upon needle tip inserted into target lesion."
15768594|NCT04707547|Biological|immunotherapy with Nivolumab|After subjects had received radiofrequency ablation for two weeks, they were performed by immunotherapy with Nivolumab 200mg.
15768595|NCT04707547|Procedure|Radiofrequency Ablation|The most commonly used local ablation is radiofrequency ablation. In this operation, a radio frequency probe is used to insert the liver cancer under ultrasound or computer tomography guidance, and then the radio frequency waves generated by the current oscillations locally heat the high temperature, causing the liver cancer cells to die.
15768596|NCT04707534|Drug|Dexamethasone|Dexamethasone
15768597|NCT04707521|Behavioral|3M tape ship-shaped combined with strap fixing method|During fixation, the endotracheal intubation and dental pad were located in the center of the mouth, and one end of one piece of medical cloth adhesive was pasted on the patient's cheek near the side. When it reached one side of the mouth, the endotracheal intubation and dental pad were wound around twice, and then the other side of the adhesive tape was pasted on the cheek opposite the side from the other side of the mouth,The other is fixed in reverse with the same sticking method, and the two pieces of adhesive tape are finally crossed and fixed at the corners of the mouth.Finally, fasten it with a lacing
15768598|NCT04707508|Drug|Valsartan 80 mg and metformin|Valsartan 80 mg once daily in addition to metformin monotherapy
15768599|NCT04707508|Drug|Metformin|Metformin monotherapy
15768600|NCT04707495|Device|Smartphone Application (SPSRS)|"The experimental group receives video-viewing intervention using the SPSRS application, which is a smartphone application. SPSRS is programmed to present 150 ms of positive words after presenting 17 ms of self-confidence-boosting words in videos.
~These words are repeated every 5 s. The words to increase self-confidence are can, let us try, good luck, able, and do not worry. These self-confidence-boosting words randomly appear in the four corners of the screen. The positive words are nice, great, fantastic, satisfactory, and enjoyable. These words are displayed at the center of the screen. Interveners use the SPSRS application according to the operating manual. The participants will use an iPhone managed by interveners to watch a pre-determined 10-minute video."
15768601|NCT04707495|Device|Smartphone Application (YouTube)|The control group uses the same iPhone as the experimental group. The control group uses the YouTube application to receive video-viewing intervention. The control group videos do not show confidence-boosting and positive words. The control group watches the same video as the experimental group for 10 min.
15768603|NCT04707456|Other|Training operator|"After recruitment, the participants were divided into two groups to perform first-trimester ultrasound scan by two different levels of proficiency.
~First group : operator has experience more than 3 years in NT scan and second trimester ultrasound scan Second group : operator has experience less than 3 years in NT scan and second trimester ultrasound scan"
15768604|NCT04707443|Other|donor human milk|"Donor human milk: from our center's milk bank
~Starting dose: 10-20 ml/kg/day (specific according to the amount of fistula or excrement).
~Evaluate twice every 24 hours, observe for at least 24 hours before volume advancement.
~Target dose: 150mL/kg/d (energy: 100 to 140 kcal/kg/d).
~Duration: from the first day when the patient start enteral feeding to the 28th day, lasting for four weeks."
15768605|NCT04707443|Other|extensively hydrolyzed formula|"eHF：commercial formulation, distribution from enteral nutrition preparation room of our center
~Starting dose: 10-20 ml/kg/day (specific according to the amount of fistula or excrement).
~Evaluate twice every 24 hours, observe for at least 24 hours before volume advancement.
~Target dose: 150mL/kg/d (energy: 100 to 140 kcal/kg/d).
~Duration: from the first day when the patient start enteral feeding to the 28th day, lasting for four weeks."
15768606|NCT04707430|Other|blood progesterone test|progesterone levels on blood sample
15768607|NCT04707417|Other|Home care|Advanced home care
15768608|NCT04707404|Procedure|Cranioplasty|The surgery implanted artificial material to repair the skull defect.
15768714|NCT04706546|Other|Hemodynamic effect of exercise|"Inhalation of room air through an altitude simulator (Altitrainer), for approx. 1/2 hour given by a facemask, first at rest and then during exercise."
15768613|NCT04707378|Device|repetitive transcranial magnetic stimulation(rTMS)|Each patient will be given 10 treatment sessions per week for 2 weeks (a total of 10 sessions). In each rTMS session, 1200 pulses of stimuli at an intensity of 100% rest motor threshold (RMT) will give over the left DLPFC. Each session is 20 minutes long and will be consisted of 10Hz stimulation trains (active) over the left DLPFC. For sham control rTMS blocks, the coil will be oriented 90◦ away from the scalp so that no pulses perturbed underlying neural tissue.
15768614|NCT04707365|Biological|Tumor samples|for each patient: liver sampling, blood samples ( serum, plasma, PBMC, whole blood), per-endoscopic bile sampling, stool samples, and materials derived from fresh tumors
15768615|NCT04707352|Drug|Dapagliflozin|All eligible subjects will receive Dapagliflozin 10 mg each day. The study treatment will be provided for the duration of the trial from baseline (Day 1) through last visit (Day 180).
15768616|NCT04707339|Procedure|Appendicectomy|Laparoscopic or Open Appendicectomy
15768617|NCT04707326|Drug|Dolutegravir / Lamivudine Pill|HIVRNA suppressed patients without documented M184V mutation in HIV RT and who are hepatitis B immune or have no risk factors for acquiring hepatitis B
15768618|NCT04707313|Drug|Placebo|4 matching placebo tablets taken twice daily
15768619|NCT04707313|Drug|PF-06882961|Participants will be randomized to one of 5 active target dose levels (40, 80, 120, 160 or 200 mg) achieved through 1-week titration steps (standard titration) or 3 active target dose levels (120, 160 or 200 mg) achieved through 2-week titration steps (slow titration), taking 4 tablets twice daily
15768621|NCT04707287|Other|No Intervention|No intervention used. This is observational study
15768622|NCT04707274|Other|Survey study|Victorian Institute of Sports Assessment for Gluteal Tendinopathy (VISA-G) Questionnaire will be applied.
15768627|NCT04707235|Drug|Hydroxycarbamide|Patients, aged ≥ 2 years old, with symptomatic SCD, treated with Siklos®.
15768628|NCT04707222|Drug|Ciprofloxacin & Metronidazole|Ciprofloxacin, 500 mg 2/day & Metronidazole (Flagyl), 500 mg 3/day
15768629|NCT04707222|Other|Placebo|Placebo pills
15768630|NCT04707222|Other|Fecal microbiome transplant|Fecal bacteriotherapy is the process of transferring stool from a healthy donor to another.
15768631|NCT04707209|Drug|Sirolimus|"An intravitreal injection of 20 µL of drug will be given through the pars plana of the eye. The injected eye will be treated with topical antibiotic and steroid eye drops prescribed for 7 to 10 days after the injection. The first injection will only be provided into the worse eye despite both eyes showing signs of exudation. Injection into the other eye will be considered only two months after the safety of this first injection is determined.
~Safety and efficacy of treatment will be determined by repeat eye examinations in the eye clinic one day, one week and one month after each injection.
~Injections will be repeated every eight weeks. A total of 3-6 injections will be given per eye, over 6-12 months. The current treatment plan is for a maximum of six injections per eye, which may be amended to accommodate more in the future."
15768632|NCT04707196|Drug|Abemaciclib|Administered orally
15768633|NCT04707196|Drug|Nonsteroidal Aromatase Inhibitor (NSAI)|Letrozole administered orally or anastrozole administered orally (physician choice)
15768634|NCT04707196|Drug|Fulvestrant|Administered intramuscularly
15768635|NCT04707183|Drug|Lidocaine IV Infusion|Lidocaine will infused through erector spinae plane block catheter in patients with traumatic rib fracture.
15768636|NCT04707183|Drug|2% Lidocaine via ESPB|10 ml of 2% lidocaine will be infused through ESPB in treatment group
15768637|NCT04707170|Device|MRI with gadolinium injection|"Patients presenting for imaging for whom an MRI examination with gadolinium injection has been prescribed and who meet the inclusion and non-inclusion criteria will be offered to participate in the study.
~The patients included, hospitalized at the A. de Rothschild Foundation Hospital for at least 24 hours, may be included in the ancillary study to meet secondary objective number 5."
15768640|NCT04707144|Device|MRI 1.5 tesla|"standard imaging protocol prescribed as part of the usual treatment: sagittal T1 and T2 slices after injection of contrast product (Gadolinium), o 3D STIR sequence.
~3D PSIR sequence at the level of the cervical cord for the duration of the additional sequence is 10 minutes, for a total examination time of 45 minutes (instead of 35 minutes)"
15768641|NCT04707131|Drug|LEM-S401|siRNA encapsulated in DegradaBALL®
15768642|NCT04707131|Drug|Placebo|Placebo
15768643|NCT04707118|Drug|cisplatin+Nab-paclitaxel+GEM|Laparoscopic exploration + thermal perfusion cisplatin 40 mg/m2, Postoperative exploration D1, 8 Nab-paclitaxel 125 mg/m2, GEM 1000 mg/m2, D1, 8, 15 after the second thermal perfusion 4 weeks plan, 6 cycles
15768644|NCT04707118|Drug|Nab-paclitaxel+GEM|Nab-paclitaxel 125 mg/m2, GEM 1000 mg/m2, D1, 8, 15 4 weeks plan, 6 cycles
15768645|NCT04707092|Drug|Antibiotic|Antibiotic in case of now allergies will be Cefazolin at induction and Amoxicillin plus Clavulanic acid for the oral treatment week
15768646|NCT04707079|Drug|Duvelisib|Eligible subjects will be given duvelisib orally at a dose of 25 mg BID during each 28-day treatment cycle, for up to 12 cycles.
15768647|NCT04707066|Behavioral|Treatment As Usual (TAU)|Treatment As Usual
15768648|NCT04707066|Behavioral|Collaborative Assessment and Management of Suicidality (CAMS) - Phase 1|Collaborative Assessment and Management of Suicidality
15768649|NCT04707066|Behavioral|Dialectical Behavior Therapy (DBT) - Phase 2|Dialectical Behavior Therapy
15768650|NCT04707066|Behavioral|Maintenance/Monitoring - Phase 2|Maintenance/Monitoring
15768651|NCT04707066|Behavioral|Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2|Collaborative Assessment and Management of Suicidality (CAMS) - Phase 2
15768652|NCT04707040|Other|Neurocognitive Exercise Program|Neurocognitive Exercise Program (NEP) is defined as a multimodal exercise program including different motor coordination exercises and cognitive tasks. Exercise progression is performed from easy to difficult, and consist of simple and complex tasks. Different sports equipment (such as different sizes of balls, racket, tulle, pilates ball, eye band, rope, etc.) is used in motor coordination exercises where multiple extremities can be used in NEP. These materials are used during different exercises including cross-limb movements, throwing, jumping, walking, involving different cognitive tasks. The cognitive task used and the degree of difficulty of the task are provided by different visual (colored cards, numbered cards, gestures, etc.) or auditory (keywords, ring signal, etc.) signs. For example, showing a red card might indicate throwing a ball with the left hand, while showing a blue card indicates throwing a ball with the right hand and walking forward
15768653|NCT04707027|Drug|Aflibercept Injection (2 mg/0.05 ml)|Intravitreal aflibercept injections (treat and extend regimen)
15768654|NCT04707027|Other|Defer treatment|Follow up with fundus photo and OCT every 4 weeks
15768655|NCT04707014|Behavioral|Hypnosis|Rapid conversational hypnosis
15768656|NCT04707014|Behavioral|Attention-distracting techniques|i-pad with movies, games and music
15768657|NCT04707001|Other|Catheterization based on ultrasound|Bladder volume ultrasound
15768658|NCT04707001|Other|Catheterization based on evaluation of symptoms|Ask for symptoms: Need to urinate, lower abdominal pain
15768659|NCT04706988|Other|Treatment of asthma according to GINA guideline|Pharmacological treatment depending on level of control of asthma
15768660|NCT04706975|Drug|difelikefalin 2.0 mg|Oral difelikefalin 2.0 mg administered twice daily
15768661|NCT04706975|Drug|Placebo|Oral Placebo administered twice daily
15768662|NCT04706962|Drug|TH1902|Intravenous infusion
15768663|NCT04706949|Drug|Pyrotinib combined with pemetrexed plus carboplatin|"Pyrotinib: oral administration within 30 minutes after breakfast, 400mg / day, continuous administration for 21 days as a cycle; each continuous pause time and the cumulative pause time of each cycle should not exceed 14 days. It is allowed to suspend the drug for many times due to adverse events.
~Pemetrexed: the recommended dosage is 500mg / m2, once every three weeks. 3) Carboplatin: the dosage was determined according to Calvert formula, in which AUC was 5mg / ml / min."
15768664|NCT04706936|Biological|anti-BCMA CAR-T|Retroviral vector-transduced autologous T cells to express anti-BCMA CAR.
15768665|NCT04706936|Drug|Cyclophosphamid|300mg/m2/d
15768666|NCT04706936|Drug|Fludarabine|30mg/m2/d
15768667|NCT04706923|Drug|BCV|BCV 0.2 mg/kg BIW, 0.3 mg/kg, or 0.4 mg/kg dosed BIW or 0.4 mg/kg dosed QW via IV infusion for 2 hours
15768668|NCT04706910|Drug|18F-DOPA|All participants will receive an intravenous injection of 18F-DOPA (4MBq/kg; minimum 110 MBq, maximum 600 MBq) for this study
15768669|NCT04706910|Drug|Furosemide Injection|Some participants will receive an intravenous injection of furosemide (40mg, single dose)
15768670|NCT04706897|Drug|Dexmedetomidine, ketamine and lidocaine|A loading infusion of syringe (B) containing the a mixture [dexmedetomidine (2 µg/ml), ketamine (0.5 mg /ml) and lidocaine (4 mg /ml)] was started at rate of 0.2 ml/kg/h ten minutes before induction. Then anesthesia was induced with 2 mg/kg IBW of propofol, patients were intubated with the aid of 0.5 mg/kg IBW atracurium and received 0.1ml/kg from syringe (D) containing normal saline (as masking for fentanyl in the control group).
15768671|NCT04706897|Drug|Normal saline|A loading infusion of the 50 ml syringe (A) containing normal saline was started at rate of 0.2 ml/ kg/hr ten minutes before induction (as masking for mixture in group S). Then anesthesia was induced with 2 mg/kg ideal body weight (IBW) of propofol , patients were intubated with the aid of 0.5 mg/kg IBW atracurium and received 0.1ml/kg from syringe (C) containing fentanyl (1mic/kg of IBW).
15768672|NCT04706884|Device|Near infrared spectroscopy|The rSO2 (cerebral oxygen satutation) was continuously monitored by NIRS (Near infrared spectroscopy) with a sensor positioned on the forehead of the patient
15768673|NCT04706871|Device|taVNS|"taVNS was applied using a Huatuo stimulator (SDZ-IIB) developed by Suzhou manufacture of Medical Device and Material. Stimulation parameters was 1 mA of electrical current at a frequency of 30 Hz with pulse duration ≤ 1 ms, for 30min, administered twice daily.
~The two electrodes were placed on the cymba conchae and concha around the left ear."
15768674|NCT04706871|Device|tnVNS|"tnVNS was applied using a Huatuo stimulator (SDZ-IIB) developed by Suzhou manufacture of Medical Device and Material. Stimulation parameters was 1 mA of electrical current at a frequency of 30 Hz with pulse duration ≤ 1 ms, for 30min, administered twice daily.
~The two electrodes were placed on the antihelix around the left ear."
15768675|NCT04706858|Dietary Supplement|Dietary fiber supplementation|Randomization to the order of first fiber: either inulin or arabinoxylan. Third cycle will include a mix of 5 fibers: inulin, arabinoxylan, resistant starch, glucomannan, and acacia gum.
15768676|NCT04706832|Device|Thoracic Splanchnic Magnetic Neuromodulation Therapy|ThorS-MagNT is performed by low-frequency, low-intensity repetitive magnetic stimulation bilaterally around T7-8 intervertebral space twice a day for 5 days with a total 1200 magnetic stimulations per treatment session at 1 Hz.
15768677|NCT04706806|Dietary Supplement|apple cider vinegar|2 tablespoons diluted in water taken twice daily with meals
15768678|NCT04706806|Dietary Supplement|vinegar pill|one pill taken daily
15768679|NCT04706793|Drug|Etrasimod|Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks
15768680|NCT04706793|Drug|Placebo|Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks
15768681|NCT04706780|Other|ESP block|ESP block performed using ultrasound guidance. Diaphragmatic excursion was measured using M-mode ultrasound during normal breathing, deep breathing and with the sniff manoeuvre.
15768682|NCT04706767|Drug|Co-administration Lidocaine and Dexmedetomidine|Patients received a bolus infusion of lidocaine (2%; 1.5 mg/kg) and dexmedetomidine (0.5 µg/kg) over 10 min before the induction of anesthesia, and then lidocaine and dexmedetomidine were infused at a rate of 1.5 mg/kg/h and 0.4 µg/kg/h until close of the pneumoperitoneum, respectively.
15768683|NCT04706767|Drug|Dexmedetomidine infusion|Patients received a bolus infusion of dexmedetomidine (0.5 µg/kg over 10 min before the induction of anesthesia), and then dexmedetomidine was infused at a rate of 0.4 μg/kg/h until close of the pneumoperitoneum.
15768684|NCT04706767|Drug|Lidocaine infusion|Patients received a bolus infusion of lidocaine (2%; 1.5 mg/kg over 10 min before the induction of anesthesia), and then lidocaine was infused at a rate of 1.5 mg/kg/h until close of the pneumoperitoneum.
15768685|NCT04706767|Drug|Saline infusion|Patients received the same volume of normal saline 10 min before the induction of anesthesia, and then normal saline (0.9%) was continuously infused in an equal volume until close of the pneumoperitoneum.
15768686|NCT04706754|Other|Questionnaires|Prospectively enrolled participants will be provided with survey packets comprised of different questionnaires at the initial/baseline visit and every 3 months and/or whenever there is an update in their treatment protocol
15768687|NCT04706741|Drug|ABY-035|ABY-035 is an Interleukin-17 Inhibitor that will be administered subcutaneously
15768688|NCT04706741|Drug|Prednisolone/Prednisone|Background Corticosteroid
15768689|NCT04706741|Drug|Placebo|Placebo to ABY-035
15768690|NCT04706728|Other|Listening to playlists with music prior to-, during and after the ECT procedure|Patients choose between two expert-curated playlists with music one day prior to ECT procedures for the first four weeks of their ECT treatment.
15768691|NCT04706728|Other|Listening to playlists with music prior to-, during and after the ECT procedure|Patients choose between two expert-curated playlists with music one day prior to ECT procedures for the first two weeks of their ECT treatment.
15768692|NCT04706728|Other|Listening to playlists with sound from nature (rain, waves) prior to-, during and after the ECT procedure|Patients choose between two expert-curated playlists with sounds from nature one day prior to ECT procedures for the first two weeks of their ECT treatment
15768693|NCT04706715|Other|89Zr-DFO-REGN3767|Anti-LAG-3 PET imaging tracer
15768694|NCT04706715|Drug|Cemiplimab|Cemiplimab 350 mg every 3 weeks with or without platinum-based chemotherapy.
15768695|NCT04706702|Behavioral|Tele-EnhanceFitness|Livestream, instructor-led tele-exercise classes, involving balance, endurance, and strength training
15768696|NCT04706689|Behavioral|SWADOC tool|"The tool explores some oral and pharyngeal components of swallowing as well as a range of prerequisite and related components of swallowing in DOC patients.
~It is composed of an average of 50 qualitative items and a subsection named SWADOC-scored comprising 8 quantitative items."
15768697|NCT04706689|Behavioral|FOTT-SAS|"Facial Oral Tract Therapy Swallowing Assessment of Saliva : the results of the SWADOC-scored in one of the sessions will be compared to the FOTT Swallowing Assessment of Saliva (FOTT-SAS) (27). The test is based on 7 questions under which if items 1-4 are answered Yes and items 5-7 are answered No, oral intake should be initiated. The FOTT-SAS includes items that can be scored based on the administration of the SWADOC tool. In that respect, no additional administration will be required"
15768698|NCT04706676|Behavioral|Integrative neuromuscular training (INT)|"Integrative neuromuscular training (INT), contains a multifaceted range of developmentally appropriate activities that incorporate general and specific strength and conditioning elements such as strength, power, motor skill training, dynamic stability, core-focused strength, plyometric and agility. INT can be camouflaged as games and play or performed as structured strength and conditioning program, depending on the participant's age, motor skill level and diagnosis. The intervention is designed to enhance health- and skill-related components of physical fitness.
~Parents or guardians will receive education in conducting INT at home, alongside an exercise-kit consisting of training equipment corresponding to the child's age and fitness level (fitness ropes, medicine ball, dumbbells).
~The INT group will receive usual standardized hospital care, including physiotherapy if needed."
15768699|NCT04706676|Behavioral|Active control group: home-based training program|"The active control group is offered a home-based training program consisting of combined aerobic, strength and stretching exercises. Further, they will receive monthly motivational consultations, as described below, concerning the training program. The use of the home-based training program will be monitored through exercise journals.
~The INT group will receive usual standardized hospital care, including physiotherapy if needed."
15768700|NCT04706676|Behavioral|motivational counseling session|"Each child and their parents will participate in a monthly 30-minute motivational counseling session to adjust the intervention and training program according to the child's physical capacity and preferences. Further, the session will determine potential barriers towards performing physical exercise using the Self-efficacy for Exercise Scale.
~The sessions are based on the principles in Self-Determination Theory that includes a spectrum of external and internal motivation factors for engaging in exercise. Each session will provide guidelines to increase the general activity levels and adjust the intervention according to the child's preferences and presence of symptoms."
15768701|NCT04706637|Drug|Evogliptin|evogliptin 5mg + metformin, oral administration once a day for 48 weeks
15768702|NCT04706637|Drug|Dapagliflozin|dapagliflozin 10mg + metformin, oral administration once a day for 48 weeks
15768703|NCT04706624|Behavioral|High intensity contingency management|Participants receive 12 weeks of contingency management.
15768704|NCT04706624|Behavioral|Low intensity contingency management|Participants receive 6 weeks of contingency management and 6 weeks of group education.
15768705|NCT04706624|Behavioral|SMS reminders|Participants receive two daily SMS reminders plus one weekly self-monitoring assessment.
15768706|NCT04706624|Behavioral|Matrix only|Participants attend 12 weekly Matrix group counseling sessions.
15768707|NCT04706624|Behavioral|Matrix + Contingency management|Participants attend 12 weekly Matrix group counseling sessions plus 12 weeks of contingency management.
15768708|NCT04706611|Procedure|Fecal Microbiota Transplantation|Procedure: Fecal Microbiota Transplantation
15768709|NCT04706598|Drug|Camrelizumab|Solution for Infusion (Intravesical and Intravenous) .
15768710|NCT04706572|Other|Stimulation with external auditory bio-feedback|Administration of an external cue based on a personalized Golden Ratio -rhythm or a metronome-rhythm through an ad-hoc App for Smartphone
15768711|NCT04706559|Drug|Probiotic sachet containing mixture of four strains i.e.Lactobacillus rhamnosus, Lactobacillus acidophilus, Bifidobacterium longum, and Saccharomyces boulardii|Interventional group: Children with AD meeting eligibility criteria receiving probiotics and conventional treatment (topical corticosteroid, topical tacrolimus, an oral antihistamine and emollients).
15768712|NCT04706559|Drug|Conventional treatment|topical corticosteroid, topical tacrolimus, an oral antihistamine and emollients as per atopic dermatitis treatment guidelines.
15768713|NCT04706546|Other|Hemodynamic effect of exercise under Sildenafil|"Inhalation of room air through an altitude simulator (Altitrainer), for approx. 1/2 hour given by a facemask, first at rest and then during exercise under SIldenafil."
15768715|NCT04706533|Diagnostic Test|Biomarkers of inflammation|Biomarkers were measured on blood samples collected within 48 hours of admission
15768716|NCT04706520|Dietary Supplement|Study Beverage Consumption|All participants will follow the same intervention as the study staff is blinded in addition to the participant. Randomized participants will be asked to consume 2 bottles per day of a study beverage for 12 weeks. Compliance checks will occur remotely by having participants send photos of their bottles each day and weekly phone/video calls with intervention staff. Participants will be asked to keep their diet and activity level consistent throughout the 12 weeks.
15768717|NCT04706507|Drug|IV Ganciclovir|For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
15768718|NCT04706494|Dietary Supplement|AlphaWave® LTheanine|200 mg of AlphaWave® LTheanine
15768719|NCT04706494|Dietary Supplement|Placebo|microcrystalline cellulose
15768720|NCT04706481|Procedure|Specimen Collection|Specimens obtained from surgical, phlebotomy or other non-invasive procedure
15768721|NCT04706468|Drug|TG-1000|Capsules taken orally
15768722|NCT04706455|Device|sodium hyaluronate 0.1%|Instillation of one drop sodium hyaluronate 0.1%
15768723|NCT04706455|Device|sodium hyaluronate 0.3%|Instillation of one drop sodium hyaluronate 0.3%
15768724|NCT04706442|Other|Supportive Parenting Application|The Supportive Parenting Application is a theory-based perinatal educational intervention for couples administered through a mobile application. The mobile app consist of knowledge-based content, informational videos and audio, discussion forum, chat groups with peer volunteers, and an experts advice section
15768725|NCT04706429|Drug|Trientine|Trientine dihydrochloride is a white to pale yellow crystalline hygroscopic powder.
15768726|NCT04706429|Drug|Placebo|Placebo capsule, manufactured with the exact components of the trientine capsules, without the active ingredient / investigational medicinal product.
15768727|NCT04706416|Dietary Supplement|N-acetyl glucosamine (NAG)|Patients with novel coronavirus (COVID-19) will be treated with N-acetylglucosamine (NAG) (700 mg every 12 hours) as first-line treatment for 30 days, along with standard of care.
15768728|NCT04706403|Behavioral|Healthcare Providers' Communication about the COVID-19 Vaccine|Participants who express hesitation about getting vaccinated for COVID-19 will be randomized to receive one of five different versions of messages from a healthcare provider (experimental groups) or a control message (control group). The messages that participants in each experimental group receive will vary slightly and systematically. Specific content and wording of these messages will be developed to address and mitigate concerns of those at risk for not being vaccinated.
15768729|NCT04706390|Biological|covid-19 vaccine|vaccination
15768730|NCT04706377|Dietary Supplement|B12 fix 1000mcg|oral dispersible tablet with vitamin B12 1000mcg
15768731|NCT04706377|Other|Placebo|Placebo tablet
15768732|NCT04706364|Behavioral|Neuropsychological Testing|Includes an IQ test, Autism Diagnostic Observation Schedule-2 (ADOS-2), and Autism Diagnostic Interview-Revised (ADI-R) assessments.
15768733|NCT04706364|Genetic|(Optional) Saliva Collection|"The sample is to test for genes (BDNF/APOE/COMT) that everyone has, but people have different varieties of these genes.
~Genetic testing is funded by Boston Children's Hospital."
15768734|NCT04706364|Device|Sensory Testing|"Three different tests will be completed:
~the tactile prepulse inhibition test (PPI) texture perception indentation testing (Mechanical Detection Threshold).
~Investigators will also apply mild electrical stimulation to the median nerve of the hand (on the wrist).
~The second sensory visit will be another version of the PPI testing involving hearing and sound."
15768735|NCT04706364|Device|Electroencephalogram (EEG)|A cap will be placed on the participants head that will be filled with electrodes (small discs). The EEG will allow investigators to measure how the brain reacts to the sensory testing.
15768736|NCT04706364|Device|Transcranial Magnetic Stimulation|"Single pulses of TMS, as well as PAS (a second type of TMS), will be applied to the cortex.
~There will be two - four identical TMS testing visits."
15768737|NCT04706351|Other|IdFAI questionnaire|The Identification of Functional Ankle Instability (IdFAI) is a newly published questionnaire that was specifically designed to detect whether individuals meet a minimum criteria necessary for inclusion in an FAI population. The IdFAI is intended to give both researchers and clinicians a simple and effective tool to determine an individual's ankle stability status
15768738|NCT04706338|Device|TMS treatment|Using TMS to stimulate (5 Hz, 90%~110% resting motor threshold) patients' primary motor area and SMA.
15768739|NCT04706325|Other|ACUTE KIDNEY INJURY|KDIGO LEVELS
15768740|NCT04706312|Other|stem cells|hAMSCs injection via venous in the dorsum of hand
15768741|NCT04706299|Other|Resistance Exercise|Participants will perform for each leg, 3 sets comprised of 15 repetitions set to 180 degrees per second of an isokinetic, concentric knee extension and flexion. Resulting in a 20 second long working set (10 seconds extension, 10 seconds flexion), per set. Each set will be followed by a 90 second period of recovery. After completing 3 sets on initial leg, testing will be set up for second leg.
15768742|NCT04706286|Drug|CKD-501, D759, D150|CKD-501 0.5 mg 1T, D759 100 mg 1T and D150 1000 mg 1T, single oral administration under fed condition
15768743|NCT04706286|Drug|CKD-393 0.5/100/1000 mg|CKD-393 0.5/100/1000 mg 1T, single oral administration under fed condition
15768744|NCT04706273|Device|GORE® VIABAHN® Endoprosthesis|On Day 1, Participants will receive the GORE® VIABAHN® Endoprosthesis
15768745|NCT04706247|Other|thoracic combined spinal epidural anesthesia|A combined spinal-epidural anesthesia set will be used for the block. Using the loss of resistance to saline technique, an 18 G Tuohy needle will be advanced to the T2-3 vertebral interspace with the mid-line approach. After confirming the epidural space, a 26 G pencil point spinal needle will be inserted slowly through the Tuohy needle to puncture the dura. After free flow of cerebrospinal fluid will be observed, local anesthetic wil be injected into the subarachnoid space over 15 secs. Then, an epidural catheter will be inserted into the epidural space.
15768746|NCT04706221|Device|CM-1500|Blood volume monitor CM-1500
15768773|NCT04705974|Procedure|Fascia iliaca block|Fascia iliaca block will be performed under ultrasound guidenance.
15768774|NCT04705974|Procedure|Femoral nerve block|Femoral nerve block will be performed under ultrasound guidenance.
15768775|NCT04705974|Procedure|Pericapsular nerve group block (PENG block)|Pericapsular nerve group block (PENG block) will be performed under ultrasound guidenance.
15835192|NCT04163263|Drug|Vehicle|topical gel
15768747|NCT04706208|Behavioral|Cognitive Multisensory Therapy|Cognitive multisensory rehabilitation (CMR) is a type of physical therapy that incorporates conscious perception of body positions and movements during (multi)sensory discrimination exercises. The treating therapists will give 40 minutes of discrimination exercises embedded in functional movements followed by 5 minutes of applying the learned strategies during activities of daily living. CMR uses several types of discrimination exercises: Participants discriminated shapes, length, weight, distance, resistance, textures or compare kinesthetic information with visual information for integration of multisensory information. Solving the discrimination task is combined with reflection and a learning process, prompted by the therapist on how the limb (was) moved or was positioned.
15768748|NCT04706208|Other|Usual Care|Standard of care treatment for neuropathic pain after spinal cord injury
15768749|NCT04706208|Behavioral|Clinical Assessment|Clinical assessments are detailed below. Screening will include demographic and general health data; mini mental state evaluation (MMSE)-short version; Edinburgh handedness inventory; and the kinesthetic and visual imagery questionnaire (KVIQ).
15768750|NCT04706208|Behavioral|Magnetic Resonance Imaging (MRI)|The MRI scanning will include structural scans, resting-state functional MRI, and 4 task-based functional MRI.
15768751|NCT04706208|Other|OPTIONAL: blood draw|This part is OPTIONAL: 38ml of blood will be taken one time (for able body adults) or at 3 time points (for adults with spinal cord injury and neuropathic pain.
15768752|NCT04706195|Behavioral|Person-centred care at distance through an eHealth platform|Person-centred care at distance through an eHealth platform, used by professionals, patients and relatives
15768753|NCT04706182|Procedure|Platelet-rich fibrin (PRF)|Platelet rich fibrin (PRF) serves as a structural reservoir of cytokines such as platelet-derived growth factor (PDGF), transforming growth factor (TGF-b), insulin-like growth factor (IGF), platelet factor 4 (PF4) and vascular endothelial growth factor (VEGF) which aids in healing and preventing infection. PRF will be prepared as recommended by the manufacturer (Intra-Lock International) by centrifuging 20 mL of the subject's venous blood for 12 minutes at 2700 rpm, followed by compression. The fibrin clot will then be applied to the SSO site prior to fixation. The blood draw for the PRF will be performed approximately 15 minutes prior to fixation of the mandible. 20 mL will be drawn for each PRF side treated. The blood venous draw will be from the subject's arm or from an existing intra-venous line.
15768754|NCT04706182|Procedure|Proximal segment grooving (PSG)|Proximal segment grooving is a mechanical method to create additional space within the inferior alveolar canal to allow the IAN to rest without compression or trauma. The surgeon uses a round or acrylic bur to cautiously remove any bony spicules, and remove cancellous bone in the proximal mandibular segment. PSG will be done by using an acrylic round bur on a surgical handpiece to remove 3 to 4 mm of cancellous bone where the IAN will passively rest into prior to fixation.
15768755|NCT04706169|Device|Surface Electromyography|SEMG was used to measure the amplitude and onset of five shoulder muscle electrical signal, performing glenohumeral abduction. In this movement, the middle deltoid muscle was selected because it is a main motor. The infraspinatus muscle represented the rotator cuff muscle group. The middle deltoid muscle was selected as the representative of shoulder abduction because it is a main motor in this movement. The trapezius muscle and the serratus anterior muscle were chosen as representative established of the ascending scapular rotator muscles.
15768756|NCT04706156|Biological|COVID-19 Vaccine|Receiving coronavirus disease (COVID-19) vaccine e.g. Pfizer-BioNTech, Moderna, Oxford/AstraZeneca, or Sinovac COVID-19 Vaccine
15768757|NCT04706143|Biological|COVID-19 Vaccines|different available vaccines: live inactivated, mRNA and viral vector vaccines
15768758|NCT04706130|Drug|Primaquine|After treatment of the blood stage infection, enrolled participants will receive either no primaquine, a low dose of primaquine or a high dose of primaquine against liver parasites
15768759|NCT04706130|Drug|Artesunate|All enrolled participants will receive a 7-day treatment of artesunate ((2 mg/kg/day) to clear blood-stage parasites
15768760|NCT04706117|Device|Self-retaining bicanalicular intubation stent|self-retaining bicanaliculs intubation setII(SRSII) which is the latest innovation in the field as these silicone stent segments traverse both canaliculi till the lacrimal sac. In which each end of this semicircular device has 2 stout angulated wings/flanges which pose no resistance while proceeding forward into the canaliculus, but once they get into open cavity (lacrimal sac), the flanges open up and give resistance to their removal against the common canalicular opening
15768761|NCT04706091|Drug|Suvorexant|10-mg or 20-mg suvorexant capsules
15768762|NCT04706091|Other|Placebo|Matching placebo capsules
15768763|NCT04706078|Diagnostic Test|The biotype of gingival|The biotype of gingival was also determined by periodontal probe.
15768764|NCT04706065|Genetic|SHMT1 polymorphism|It is to identify the role of SHMT1polymorphism in PD and examine the relationship between it and Severity of PD.
15768765|NCT04706052|Other|Superficial Parotidectomy|Classical procedure for pleomorphic adenoma of the parotid gland is superficial parotidectomy around the world. This study only observed the outcome with reference to facial nerve morbidity
15768766|NCT04706039|Diagnostic Test|Performance evaluation (sensitivity and specificity) for COVID-19 diagnosis of the Vocus PTR-TOF process|"Each patient will be sampled to do a systematic respiratory virus infection screening (SARS-CoV-2 and Flu and RSV). Then each patient will be tested using the Vocus PTR-TOF process.
~A self-answering questionnaire will be used to collect symptomatology information and date of onset of symptoms."
15768767|NCT04706026|Other|Local anesthesia|This is the treatment group. Patients will receive an injection of a 50:50 mix of 1% lidocaine with epinephrine and 0.25% Marcaine at the surgical site (in the skin and subcutaneous layers + beneath the external oblique aponeurosis). Patients in the local arm will also receive intravenous sedation (propofol or Precedex) and pain medication (morphine or fentanyl) at the discretion of the attending anesthesiologist.
15768768|NCT04706026|Other|General anesthesia|This group is the active comparator. General anesthesia will be administered at the discretion of the anesthesiologist and will involve a combination of inhaled and intravenous anesthesia.
15768769|NCT04706013|Drug|Pyridoxal Phosphate|Oral tablets 50 mg
15768770|NCT04706000|Genetic|Beclin 1 gene|The determination of Beclin 1, LC3-II and p62 genes, which are evaluated by immunohistochemistry, at the protein level will be done by ELISA method in MSKU Medical Faculty Medical Biology Laboratory.
15768771|NCT04705987|Drug|Colchicine 0.5 MG|Colchicine 0.5 mg/24h Treatment 8 weeks
15768772|NCT04705987|Drug|Placebo|Placebo 1c/24h Treatment 8 weeks
15768776|NCT04705948|Drug|Magnesium sulfate versus ketamine|Magnesium sulfate versus ketamine for of post-operative sore throat after endotracheal intubation
15768777|NCT04705922|Drug|TT-00420 Capsule|TT-00420 capsule formulation, administered orally
15768778|NCT04705922|Drug|TT-00420 Tablet|TT-00420 tablet formulation, administered orally
15768779|NCT04705909|Drug|Pitavastatin|Pitavastatin 2 mg oral tablets daily will be given to the patients concomitantly with the intended chemotherapy protocol for the treatment period prior to surgery.
15768780|NCT04705909|Drug|placebo|patients in this group will receive placebo tablets concomitantly with the intended chemotherapy for the treatment period prior to surgery.
15768781|NCT04705896|Biological|Alburex 25% Albumin fluid (100 mL)|"Participants will be randomized to receive albumin (25%) during their RRT sessions (either SLED or IHD) in ICU. Once randomized the same fluid will be given for all subsequent RRT sessions.
~RRT sessions will be determined as per the treating physician. Boluses will be given at the start of, and halfway through, RRT sessions (i.e. for SLED sessions, at 0 and 4 hours; for IHD sessions, at 0 and 2 hours)."
15768782|NCT04705896|Other|0.9% Normal Saline (100 mL)|"Participants will be randomized to receive normal saline 100 mL boluses during their RRT sessions (either SLED or IHD) in ICU. Once randomized the same fluid will be given for all subsequent RRT sessions.
~RRT sessions will be determined as per the treating physician. Boluses will be given at the start of, and halfway through, RRT sessions (i.e. for SLED sessions, at 0 and 4 hours; for IHD sessions, at 0 and 2 hours)."
15768783|NCT04705883|Drug|Prasterone (DHEA), Micronized|Vaginal prasterone 6,5mg/24h first month, next 5 months 6,5mg/48h, vaginal administration.
15768784|NCT04705870|Device|cerebral MRI|"MRI of routine care in the context of MS includes at least the following sequences:
~3D T1 TFE (2 minutes)
~T2 TSE (2 minutes)
~3D FLAIR (3 minutes)
~SWI EPI 0.6 iso (7 minutes)
~The sequences added by the search are:
~SWI non EPI QSM 6 echo (10 minutes)
~SWI EPI in resolution equivalent to non-EPI SWI (3 minutes)
~SWI EPI to TR equivalent to SWI non EPI (6 minutes)"
15768785|NCT04705857|Combination Product|"Histograft, a bone substitute based on octacalcium phosphate (OCP) and plasmid DNA encoding VEGFA gene"|gene-activated bone substitute in granular form, concentration of the plasmid DNA is 100 μg per 1.0 g of the OCP scaffold
15768786|NCT04705844|Drug|Adalimumab|adalimumab (160 mg administered as 4×40 mg subcutaneous [SC] injections at separate sites on the thigh or abdomen)
15768787|NCT04705844|Drug|Placebo|placebo (4 SC injections of equal volume administered at separate sites on the thigh or abdomen)
15768788|NCT04705831|Drug|Ruconest|C1 Esterase Inhibitor
15768789|NCT04705818|Drug|Durvalumab|Durvalumab will be administered by intraveinous infusion (1120 mg) on day 1, every 3 weeks. Treatment by durvalumab will start on Day 22 (i.e., day 1 of cycle 2)
15768790|NCT04705818|Drug|Tazemetostat|Tazemetostat will be administered per-os, twice daily (800 mg x 2), continuously. Treatment by tazemetostat will start on day 1 (of cycle1).
15768791|NCT04705805|Behavioral|Self-assessment of olfactory disorders through two questionnaires.|"Assessment of sense of smell or loss of smell using an Analogue Visual Scale
~Carrying out the objective smell test (Sniffin' sticks test) (gold standard)
~Information from two self-questionnaires translated into French: a quality of life questionnaire (The Questionnaire Olfactory Disorders (QOD)) and a self-assessment questionnaire of his olfactory capacities (Self-Mini Olfactory Questionnaire (Self-MOQ))"
15768792|NCT04705792|Procedure|Physical activity|Activities included overall stretching and strengthening (flexion, extension, adduction and abduction movements) and muscular endurance exercises (exercises involving open and closed kinetic chains), along with aerobic conditioning using a functional circuit.
15768793|NCT04705779|Behavioral|HARMONY|The HARMONY intervention will be delivered over 8 every-other-week sessions and 6 monthly booster sessions. Each session will have three components; an exercise sampler, cool down and tailored education on cardiometabolic prevention and risk reductions.
15768794|NCT04705779|Behavioral|Nutrition and Exercise Education (NEEW)|The Nutrition and Exercise Workgroup (NEEW) group will be delivered over 8 every-other-week sessions and 6 monthly booster sessions. Each session will have three components; an exercise sampler, cool down and tailored education on cardiometabolic prevention and risk reductions.
15768795|NCT04705766|Other|Urine Collection|A urine collection kit will be mailed to subjects' residence at 3 different timepoints over the course of 1 year to be returned to study team, upon which KIT score and other biomarkers will be assessed as outlined in the study design.
15768796|NCT04705753|Dietary Supplement|Cretan IAMA|Cretan IAMA (CAPeo) soft gels, 1 ml/day of a 1.5% essential oil combination from three aromatic plants (Thymbra 59 capitata (L.) Cav., Origanum dictamnus L., Salvia fruticosa Mill.) in extra virgin olive oil
15768797|NCT04705740|Other|ERCP|ERCPs performed annually by an endoscopist
15768798|NCT04705727|Drug|Budesonide Formoterol Drug Combination|This combination will be used to treat the asthma exacerbation, patients will take one inhalation of budesonide/formoterol Turbuhaler® 100/6 μg every 5 minutes (Maximum 12 inhalations).
15768799|NCT04705727|Drug|nebulisation of terbutaline|Patients will receive 0.1 mg/kg nebulized terbutaline 5 mg/2 ml of Terbutaline dilution diluted with 2 ml normal saline delivered by an air compressor nebuliser driven by oxygen at a flow rate of 8l/min. The duration of one dose will be approximately 20 minutes and a total of 3 doses will be administered.
15768800|NCT04705714|Drug|Frankincense Extract|The phytochemical composition of the volatile components of the extract was identified by GC-MS analysis, Crystal violet assay to test inhibition of biofilm formation by the tested isolates,Light microscope and scanning electron microscope were used to examine the biofilms and they confirmed the reduction of biofilm formation by frankincense extract
15768801|NCT04705701|Procedure|Hemodialysis|Renal replacement therapy is considered standard of care for end stage renal disease patients for clearing the blood and also helping with volume optimization, has different modalities, in our study we are using intermittent hemodialysis.
15768802|NCT04705675|Behavioral|Breastfeeding Education|The mothers were asked to remember the pseudonyms they used on the pretest and to use the same pseudonym on the posttest. Following the pretest, the mothers in the study group were taken into a separate room at the FHC and asked to breastfeed their infants. The mothers' breastfeeding behaviors were observed. After the breastfeeding, each mother was provided an average 30-minute session of individual education. All of the mothers in the study group received the education from the same researcher. Both audio and visual materials were used in the mothers' training.
15768906|NCT04704869|Biological|Platelets|Platelets are utilized as part of the Massive Transfusion protocol for hemorrhage control.
15768808|NCT04705649|Other|Treatment de-escalation|De-escalation from standard treatment based on molecular profile
15768809|NCT04705636|Device|"Connected device named Leo from Ludocare society"|"Connected device named Leo from Ludocare society will be allocated to each child for three-months period. During this time, child will be helped to take all of his medication and specific care by this connected device."
15768810|NCT04705623|Behavioral|Iyengar Yoga|Weekly 90 minute Iyengar Yoga classes taught y a professional instructor. Twice weekly 45 minute self practice of Iyengar Yoga at home by the participants
15768811|NCT04705610|Other|Video-oculography / Social cognition tasks / Neuropsychological evaluations|"Recording of eye movements with a video-oculography device during oculomotor paradigms (Fixations, horizontal and vertical reflex saccades, horizontal and vertical smooth pursuit, anti-saccades)
~Recording of eye gaze with a video-oculography device during emotions recognition tasks (Reading the Mind in the Eyes test (Baron-Cohen 2001); Ekman Faces task (1976))
~Neurological evaluation
~Neuropsychological evaluations
~Social cognitions tasks
~Behaviour assessment"
15768812|NCT04705597|Drug|BGE-175|Drug
15768813|NCT04705597|Other|Placebo|Placebo
15768814|NCT04705584|Drug|Prednisolone (as Acetate)|Standard treatment protocol includes Topical steroids for 8 weeks with gradual dose tapering.
15768815|NCT04705584|Drug|CycloSPORINE Ophthalmic Suspension|This treatment arm includes the use of topical cyclosporine A after 2 weeks of topical steroid use.
15768816|NCT04705584|Drug|LTacrolimus Topical|This treatment arm includes the use of topical Tacrolimus after 2 weeks of topical steroid use.
15768817|NCT04705571|Device|MorpheusV Applicator|1 treatment with the MorpheusV Applicator
15768818|NCT04705558|Other|continuous moderate intensity aerobic training|continuous moderate intensity aerobic exercises with ketogenic diet group underwent supervised moderate-intensity exercised on a treadmill at 50%-70% of heart rate reserve for three month
15768819|NCT04705558|Other|ketogenic diet|Ketogenic diet: a low carbohydrate high-fat diet consisted of the following nutrient conformation: 80% fat, 15% protein and 5% carbohydrates, entire daily intake was estimated to be 20-30 g of carbohydrates for three month.
15768820|NCT04705545|Device|transpalatal arch group|transpalatal arch is a 1.0 mm stainless steel wire connecting the upper permanent first molar, with a U loop pointing posteriorly, soldered to the palatal side of the molar bands.
15768821|NCT04705545|Device|Nance button|Nance button is a 1.0mm stainless steel wire connecting the upper permanent first molar, with a Nance button incorporated in the middle of the wire, soldered to the palatal side of the molar bands
15768826|NCT04705519|Drug|Nab-paclitaxel Combined With Bevacizumab|Nab-paclitaxel 150mg/m2 ，iv drip, d1, Bevacizumab 5mg/kg, iv drip, d1, q2w.
15768827|NCT04705506|Drug|Gemigliptin|We collected baseline data from all participants for demographic characteristics,comorbid conditions and biochemistry indexes.The biomarkers for vascular calcification and renal injury were collected.Baseline CAC score and CAVI were done.The patients then were randomized into 2 groups: Group 1 received gemigliptin 50 mg /day for 6 months in addition to standard treatment ,Group 2 will have standard treatment for diabetes mellitus (DM) and chronic kidney disease (CKD).The patients will be followed up every eight weeks.Fasting plasma glucose ,BUN creatinine and 24 hour urine protein were measured at each study visit.Patients were scheduled for follow-up visits at months 2,4,and 6.After 6 months ,all the blood tests,CAC score and CAVI will be done again.
15768828|NCT04705493|Other|fluid resuscitation with crystalloid|give two-volume of fluids initial 250ml then another 250 ml
15768829|NCT04705480|Drug|Pregabalin 50mg|Patients will receive 50 mg every 8 hours without dose titration. Patients with CrCl < 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if < 7 days post-enrollment).
15768830|NCT04705480|Drug|Gabapentin 300mg|Patients will receive 300 mg PO every 8 hours without dose titration. Patients with CrCl < 60mL/min will receive same dose given q12 hours. The q12 hour regimen may be increased to q8 hours if CrCl increases above 60mL/min during the 7 days study period or until discharge (if < 7 days post-enrollment).
15768831|NCT04705480|Drug|Neither Pregabalin nor Gabapentin|Patients will receive neither Pregabalin nor Gabapentin.
15768832|NCT04705467|Device|Gynecological brachytherapy|Management of gynecological malignancies is done through brachytherapy treatment, which involves the delivery of radiation via radioactive sources that are placed into or in close proximity to the tumour.
15768833|NCT04705454|Biological|Loncastuximab Tesirine|
15768899|NCT04704908|Drug|Recombinant Human Papillomavirus Bivalent (Types 16, 18) Vaccine (Escherichia coli)|The bivalent HPV-16/18 vaccine was a mixture of two aluminum hydroxide adjuvant-absorbed recombinant L1 VLPs of HPV-16 and HPV-18 expressed in E. coli. A 0.5 ml dose of the bivalent HPV test vaccine comprised 40 μg of HPV-16 and 20 μg of HPV-18 L1 VLPs absorbed with 208 μg of aluminum adjuvant
15768900|NCT04704895|Dietary Supplement|Total parenteral nutrition|Total parenteral nutrition, TPN also starts from POD 1 and is delivered through a central venous catheter, with a target energy of 1.5 amino acids/kg/day reaching 30 kcal/kg/day
15768834|NCT04705441|Behavioral|SMART 2|Participants receiving the SMART intervention will participate in 8 group-format 45-60 minute sessions (up to 10 participants per group), which will be collaboratively delivered over Zoom by a Nurse Educator and a Peer Educator with epilepsy. Telephone call-in and supplemental printed materials will be available for those who do not have internet access. The initial group session portion of SMART will be completed over 10-12 weeks. Educational components address the challenges imposed by epilepsy and comorbidity, as well as problem-identification and goal-setting, while Peer Educators and the group format address adherence, social support/social isolation, and self-efficacy. Following group sessions, participants will have 3 brief (no more than 15 minutes) monthly web-based or telephone maintenance sessions conducted by the Nurse Educator. Telephone sessions will address on-going issues of epilepsy self-management, including treatment adherence.
15768835|NCT04705428|Other|FLUORINE VARNISH|"Participants in all groups will receive written oral hygiene and oral prophylaxis instructions. All groups will receive the application of fluorine varnish every 3 months.
~The application of fluoride in the three groups will be done as follows:
~-Drying of the teeth, placement of the fluorine varnish on the teeth by quadrants. The varnish will be left to dry for a few seconds according to the manufacturer's instructions. Children in all groups will be asked to avoid brushing and flossing for one day after applying fluoride. They will be instructed to avoid hard food and hot drinks for 4 hours. Children and parents will be instructed on how to care for their teeth at home: brush teeth with conventional toothpaste containing 1000 ppm sodium fluoride, for 3 minutes without rinsing.
~In the following reviews (3 and 6 months) the effectiveness of the treatments will be evaluated by visual examination, tactile examination, fluorescence and photography."
15768836|NCT04705415|Drug|Niclosamide|Niclosamide is an antihelmintic with in-vitro antiviral activity
15768837|NCT04705415|Drug|Placebo|Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients
15768838|NCT04705402|Drug|Mannitol|"Mannitol (Israeli Brand Name: Osmitrol) is in the osmotic diuretic pharmacologic categoryaccording to the American Hospital Formulary Service (AHFS) database. . During the procedure, volume of 2.8 cc / kg body weight of the solution bag (either mannitol or saline 0.9%) will be given. The bag itself will be covered so it cannot be identified which solution is in it and marked per patient.
~Mannitol is injected by intravenous infusion using an I-vac pump and infused over 15 minutes."
15768839|NCT04705402|Drug|Saline|Study participants randomized to this arm will receive a 0.9% saline solution at a dose of 2.8 cc / kg, infused within 15-30 minutes prior to renal artery reperfusion through an existing intravenous access catheter (either through an central or peripheral intravenous infusion).
15768840|NCT04705389|Other|Samples|blood samples
15768841|NCT04705376|Device|Breg Polarcare|The Breg Polarcare device is a type of cryotherapy machine that circulates ice cold water into a patch that can be worn by the patient on their affected joint (e.g., shoulder, knee).
15768842|NCT04705376|Device|Thermazone|ThermaZone is a compact device that uses thermoelectric technology to provide heating and cooling therapy without the use of ice.
15768843|NCT04705363|Behavioral|Dialectal Features Varied|Participants will randomized to interact with a VHA that speaks either Standardized American English, a low level of African American English, or a high level of African American English
15768844|NCT04705363|Behavioral|Video Intervention|Participants will randomized to either receive a video introduction from the voice actor or receive no introduction
15768845|NCT04705363|Behavioral|VHA with no voice|virtual health assistant that will consist of photos of the computer-generated doctor with text that will guide you through the interaction. No voice will accompany the photos or text.
15768846|NCT04705350|Drug|Zampilimab|Participants will receive a single intravenous dose of zampilimab at a pre-specified time point.
15768847|NCT04705350|Drug|Placebo|Participants will receive matching placebo at a pre-specified time point to maintain the blinding.
15768848|NCT04705337|Drug|Levosimendan|administration of levosimendan as a continuous iv. infusion, every 4 weeks for 48 weeks (12 infusions in total)
15768849|NCT04705337|Other|Placebo|administration of glucose as a continuous iv. infusion, every 4 weeks for 48 weeks (12 infusions in total)
15768850|NCT04705324|Procedure|Operative Hysteroscopy|Separation of the non-viable gestational sac from the uterine wall will through operative hysteroscopy
15768851|NCT04705324|Procedure|D&C|Separation of the non-viable gestational sac from the uterine wall through dilation and curettage
15768852|NCT04705311|Other|Pain neuroscience education|Neurophysiological education of pain allows patients to explore a wider contribution to pain through the knowledge that pain is often an unreliable indicator of the extent or extent of tissue damage. This aims at reconceptualization from biomedical or structural models to actual biological psychosocial pain models.
15768853|NCT04705311|Behavioral|Rotator cuff repair rehabilitation|Postoperative rehabilitation programs include thermal therapy, electrical therapy, manual therapy, and therapeutic exercise.
15768854|NCT04705298|Dietary Supplement|Prebiotic|Oligofructose-enriched inulin. 4 grams daily for ≤ age 6; or 8 grams daily for >6 years
15768855|NCT04705298|Dietary Supplement|Placebo|Maltodextrin 4 grams daily for ≤ age 6; or 8 grams daily for >6 years
15768856|NCT04705285|Device|Erbium Yag Laser|Subjets in the laser arm will undergo 2 sessions of vaginal erbium-yag laser, separated by a month
15768857|NCT04705285|Behavioral|Pelvic Floor Training|Patients allocated to pelvic floor training, are goin to undergo 10 sessions of pelvic floor exercises coached by an expert physiotherapist
15768858|NCT04705272|Other|Questionnaire|Pregnant women will be included in the study at the time of their first or second trimester ultrasound in the Hautepierre and CMCO ultrasound department. The period of inclusion should extend from 1 October 2020 to 31 October 2021 with a duration of participation of each subject of 9 months.
15768901|NCT04704895|Dietary Supplement|Enteral nutrition|NJEEN was defined as providing at least 50% of the nutritional requirements through the nasojejunal tube prior to the 5th day after surgery (POD) and having no parenteral nutrition for 72 hours or more.
15768902|NCT04704882|Other|omental patchwork|the omental flaps were sewn to lesser omentum and hepatorenal ligament to cover all the vessels
15768903|NCT04704869|Biological|Cryoprecipitate|Cryoprecipitate is a blood product high in fibrinogen. The Cryoprecipitate will be given with 90 minutes of emergency department arrival. Cryoprecipitate dose will be 3 pools (equivalent to 15 single units).
15768904|NCT04704869|Biological|Red Blood Cells|RBCs are utilized as part of the Massive Transfusion protocol for hemorrhage control.
15768859|NCT04705259|Behavioral|Antimicrobial Stewardship ENGAGEMENT bundle|"Given that a single intervention is unlikely to be effective in stewardship programs, nor in care improvement processes at RACFs [7], this trial will deliver a set of multimodal, multidisciplinary interventions to optimise antibiotic use in RACFs. This RACF AMS ENGAGEMENT bundle will comprise the following key interventions:
~Education and engagement of prescribers, nurses, pharmacists and residents and family members
~Nursing initiatives to improve UTI diagnosis and reduce inappropriate urine testing
~Guideline development specific to antibiotic use in RACF residents
~Antimicrobial stewardship team creation in RACF with GP involvement
~EMergency department liaison and use of clinical pathways to ensure consistency of practice across the care continuum
~ElectroNic decision support to guide RACF urine testing and GP antibiotic prescribing
~Telehealth support for key intervention components"
15768860|NCT04705246|Behavioral|Psychoeducation|The goal of the psychoeducation session is to provide insight in the hyperacusis symptoms, take away the fear of external noises, and encourage exposure to noise.
15768861|NCT04705233|Other|sputum colour chart|5-point Sputum Colour Chart plus best standard care
15768862|NCT04705220|Dietary Supplement|MERIVA® Tablets|The treatment corresponds to 1 g / day of experimental product (corresponding to about 200 mg of curcuminoids).
15768863|NCT04705220|Other|Placebo Tablets|The composition of placebo includes the same components of the treatment tablets, except for the active substance.
15768864|NCT04705207|Procedure|reflexology massage|the patient receive only foot reflexology massage
15768865|NCT04705207|Procedure|sham massage|the patient receive only foot traditional massage
15768866|NCT04705194|Procedure|Hepatectomy|Resection of one or more liver segments as treatment for primary or metastatic liver cancer
15768867|NCT04705194|Procedure|PVE or ALPPS|Embolization of the portal vein feeding the diseased liver segments or surgical liver partition and portal vein ligation of the diseased liver segments in order to induce growth of the future liver remnant ahead of the resection.
15768868|NCT04705168|Diagnostic Test|Nevisense electrical impedance spectroscopy|Each participants will undergo Nevisense electrical impedance spectroscopy in order to characterize the electrical impedance spectroscopy scores of nevi in patients with ≥ 100 nevi on the entire cutaneous surface and at least three large acquired nevi (LAN) > 5 mm in diameter
15768869|NCT04705142|Drug|MgSo4|Before and during administration of MgSO4, B.P, Capillary refill time, Heart rate and respiratory rate will be assessed closely i-e on 10 minutes interval, infusion of MgSO4 will be give over 30 minutes and baby will be monitored every 15 minutes interval after completion of infusion as well for 1 hour.
15768870|NCT04705129|Drug|Zanubrutinib|160mg Bid, D1-21, po
15768871|NCT04705129|Drug|Tislelizumab|200mg, D1, ivgtt
15768872|NCT04705116|Biological|COVID-19 vaccine|At least one dose of a COVID-19 vaccine.
15768873|NCT04705090|Drug|YY-20394 treatment|Each treatment cycle is comprised of 28-day consecutive dosing of YY-20394, 80mg QD (days 1 to 28). Upon completion of each cycle, patients may continue to receive oral YY-20394 tablets if they are benefit from the treatment and the toxicity is tolerable.
15768874|NCT04705077|Drug|SR419|2 formulations of SR419, SR419 suspension and SR419 capsule will be used in the study.
15768875|NCT04705064|Diagnostic Test|Prediction of postoperative acute kidney injury using an artificial intelligence|The performance of an artificial intelligence model to predict postoperative acute kidney injury will be tested prospectively.
15768876|NCT04705051|Drug|Venglustat GZ402671|Pharmaceutical form:capsule Route of administration: oral
15768877|NCT04705038|Behavioral|Patient Education|Brief educational session on surgical castration as an alternative to lifelong ADT for prostate cancer.
15768878|NCT04705025|Behavioral|Cognitive Behavior Therapy|Undergo CBSM using the BNT001 app
15768879|NCT04705025|Other|Interview|Complete interview
15768880|NCT04705025|Other|Quality-of-Life Assessment|Ancillary studies
15768881|NCT04705025|Other|Questionnaire Administration|Ancillary studies
15768882|NCT04705012|Other|Submucosal supportive therapy|Increased frequency of submucosal cleaning using a rotating chitosan brush
15768883|NCT04704999|Drug|Tafenoquine|Tafenoquine will be given as 100mg coated tablets. Whole tablets will be given based on weight bands.
15768884|NCT04704999|Drug|Chloroquine|Chloroquine will be given as daily dose over 3 days (25mg/kg total dose divided 10/10/5mg/kg)
15768885|NCT04704999|Drug|Artemether 20 mg-Lumefantrine 120 mg|Artemether-lumefantrine will be given twice daily over 3 days. Whole tablets will be given based on weight bands.
15768886|NCT04704986|Device|PVI using the Arctic Front Cryoballoon (Medtronic)|"Patients randomized to the Arctic Front cryoballoon group will undergo PVI using the Arctic Front Cryoballoon (Medtronic).
~At the end of the procedure, an implantable cardiac monitor (Medtronic Reveal LINQ) will be implanted for the purpose of continuous arrhythmia monitoring."
15768887|NCT04704986|Drug|PVI using the PolarX Cryoballoon (Boston Scientific)|"Patients randomized to PolarX cryoballoon group will undergo PVI using the PolarX Cryoballoon (Boston Scientific).
~At the end of the procedure, an implantable cardiac monitor (Medtronic Reveal LINQ) will be implanted for the purpose of continuous arrhythmia monitoring."
15768888|NCT04704973|Behavioral|Transdiagnostic short-term psychotherapy|Focused clinical functional analysis, formulation of a valued life direction includings strategies to handle obstacles, and a summarizing exercise including relapse prevention.
15768889|NCT04704960|Other|Diagnostic Test: liquid biopsy|detection of tumor DNA alteration in cf-DNA
15768890|NCT04704947|Drug|nonselective beta blocker|nonselective beta blocker
15768891|NCT04704947|Drug|cardio-selective beta blocker group|cardio-selective beta blocker group
15768892|NCT04704947|Drug|alendronate sodium|alendronate sodium
15768893|NCT04704934|Drug|Trastuzumab deruxtecan|6.4 mg/kg IV infusion every 3 weeks on Day 1 of each 21-day cycle
15768894|NCT04704934|Drug|Ramucirumab|8 mg/kg IV infusion on Days 1 and 15 of a 28-day cycle
15768895|NCT04704934|Drug|Paclitaxel|80 mg/m^2 IV infusion on Days 1, 8, and 15 of a 28-day cycle
15768896|NCT04704921|Genetic|RGX-314|AAV8 vector containing a transgene for anti-VEGF Fab (Dose 1)
15768897|NCT04704921|Genetic|RGX-314|AAV8 vector containing a transgene for anti-VEGF Fab (Dose 2)
15768898|NCT04704921|Biological|Ranibizumab (LUCENTIS®)|0.5 mg (0.05 mL of 10 mg/mL solution) administered by intravitreal injection approximately every 28 days
15768905|NCT04704869|Biological|Plasma|Plasma is utilized as part of the Massive Transfusion protocol for hemorrhage control.
15768907|NCT04704869|Biological|Whole Blood|Whole Blood is utilized as part of the Massive Transfusion protocol for hemorrhage control.
15768908|NCT04704856|Behavioral|Supervised exercise|Supervised exercise during first 6 weeks of neoadjuvant chemotherapy.
15768911|NCT04704830|Biological|R21/Matrix-M|Adjuvanted malaria vaccine
15768912|NCT04704830|Biological|Rabies vaccine|Placebo Comparator
15768913|NCT04704817|Other|obsevation|prospective data collection for colonic or rectal surgery
15768914|NCT04704804|Diagnostic Test|Synthetic CT Scan|method of generating CT-synthetic image from MRI
15768915|NCT04704791|Procedure|PA-LAA shunt|At the time of surgery a covered stent will be inserted through the atriotomy into the left pulmonary artery and balloon dilated to stabilize the device. The target shunt diameter will be 3.5-4 mm to minimize LAA stasis.
15768916|NCT04704778|Combination Product|Transcutaneus electrostimulation therapies|"Sterile steel acupuncture needles of 0.25x13mm, disposable AcuBEST brand, and portable electro-stimulator equipment KWD- will be used. The superficial area of the skin of the masseter muscle will be cleaned with alcohol.
~Two needles will be placed in each masseter muscle, the area to be punctured is the origin of the masseter muscle or superficial area of the mandibular condyle anterior to the atrial tragus approximately 1cm away, insertion of the masseter muscle at the angle of the mandible. The two double alligator cables will be connected to the head of the needles. The positive pole will be connected at the origin of the masseter muscle and the negative pole at the insertion.
~The parameters to be used will be are two frequency bands (210Hz-10140Hz.); amplitude 3050 volts, pulse duration: 40100 msec; and the output intensity: 0.70 (for 100Hz). The treatment time will be 20 minutes."
15768917|NCT04704778|Combination Product|Percutaneus electrostimulation therapies|"Kendall® MediTrace 100 conductive adhesive ECG electrodes (pediatric) 2.4 cm in diameter, and portable KWD-808 electrostimulator equipment will be used.
~The superficial area of the skin will be cleaned, two electrodes will be placed on each muscle (superficial area of the mandibular condyle and at the angle of the jaw). The current leads will then be connected to the KWD-808 electroacupuncturist to the patient.
~Current will be transmitted with a square waveform, 210Hz-10140Hz of frequency, 3050 volts of amplitude and 40100 msec pulse time. The treatment time will be 20 minutes."
15768918|NCT04704778|Diagnostic Test|Oclusal splint|"The occlusal splint is worn 24 hours a day, removed for eating and brushing teeth. It is washed with neutral liquid hand soap.
~For the preparation, an impression of the maxillary dental arches will be taken with alginate; It is made with acetate .060 and .080.
~Relining is done with self-curing acrylic on the occlusal surface of the splint"
15768919|NCT04704765|Other|abdominal breathing training|The abdominal breathing training at the outpatient clinic (every day 30 minutes, can include every time during the day). When the subjects were at home, they received self-training using the abdominal breathing training video (once every day and 30 minutes every time).
15768920|NCT04704752|Diagnostic Test|Swallowing Evaluation|Study Evaluation includes basic test batteries. These are observational.
15768921|NCT04704739|Drug|GLPG1205 film-coated tablets|Single oral dose of GLPG1205
15768922|NCT04704739|Drug|[14C]-GLPG1205 solution for infusion|A 15-minute IV infusion of [14C]-GLPG1205
15768923|NCT04704739|Drug|GLPG1205 capsules|Single oral dose of GLPG1205 as solid formulation
15768924|NCT04704713|Drug|Afamelanotide|
15768925|NCT04704713|Drug|Placebo|
15768926|NCT04704700|Device|repair of a cuff tear|Group (Treatment): Arthroscopic Implantation of the System InSpace on a repaired rotator cuff tendon
15768927|NCT04704700|Device|repair of a cuff tear|Group (Control): standard Arthroscopic repair of the cuff rotator
15768928|NCT04704687|Other|Transcranial Direct Current Stimulation|Children will perform two successive interventions composed each by a set of 15 sessions of effective-tDCS combine with cognitive-training exercises.
15768931|NCT04704648|Procedure|Surgical|"The treatment involves excision only of the conjunctival lesion with 3 mm margins. Surgeons (registered as investigators at each site) will perform the operation in accordance with the procedures outlined in the AMC-104 manual of procedures (MOP).
~As part of the study patients will be asked to return for follow-up evaluation 1 week, 6 weeks, 6 months, and 12 months after surgery. At each of these follow-up visits, the AMC-certified ophthalmologist will obtain a thorough ocular history as well as a history of AIDS-defining illnesses and perform a slit-lamp examination of both eyes, complete with templated drawings of the conjunctiva, and careful examination of the cornea for limbal stem cell deficiency."
15768932|NCT04704622|Drug|Ketamine|ketamine intranasal injection,2 mg/kg, once, 30 min preoperative
15768933|NCT04704622|Drug|Midazolam|midazolam intranasal injection,0.2mg/kg, once, 30 min preoperative
15768934|NCT04704622|Drug|Dexmedetomidine|dexmedetomidine intranasal injection,1 μg/kg, once, 30 min preoperative
15768935|NCT04704609|Other|Standard of Care Imaging|We are collecting imaging that is standard of care for uveitis patients
15768936|NCT04704596|Device|anesthesia ventilator machine|dynamic lung compliance measurements will be used for detection of the optimum PEEP after alveolar recruitment
15768937|NCT04704596|Device|lung ultrasound|lung ultrasound views will be used for detection of the optimum PEEP after alveolar recruitment
15768938|NCT04704583|Behavioral|SPACE parental-guidance|The treatment will be delivered to the parents in ten 50-minute sessions. The sessions are planned to be weekly and will be completed within 13 weeks of the first session. The sessions include instruction and education, acquiring skills, role-play, and simulations. Parents will be given exercises and goals in reducing accommodation to achieve at home (in cognitive behavioral therapy this is sometimes called 'homework') in some of the sessions. For example, parents to write down one or two things that they would most like to see their child handling better.
15768939|NCT04704570|Other|Exercise|Spinal stabilization exercise
15769016|NCT04703985|Dietary Supplement|Enteral Nutrition|Protocol of Enteral Nutrition adapted to the conditioning autograft (BEAM or Melphalan 200)
15769017|NCT04703972|Behavioral|clinical assessment (mood relapses identification)|clinical assessment via psychometric scales physiological data acquired automatically via the connected device (wristwatch, wristband)
15768940|NCT04704570|Other|Remotely and face to face evaluation of Functional Capacity Level, Quality of life, Kinesophobia, Cognitive Level|Functional capacity assessment tests, quality of life assessment (SF-36), kinesiophobia assessment (Tampa Kinesiophobia Scale) and cognitive assessment ((Montreal Cognitive Assessment Scale (MOCA)) will be administered both face-to-face and remotely. All participants will be administered both remotely and face-to-face. The order of the remote and face-to-face evaluations will be determined by the closed envelope randomization method. The remote evaluation will be done by video interview method under the direction of the researcher. During the remote evaluation, the necessary equipment for the participant will be prepared in the unit in advance. There will be a 10-30 minute rest interval between each evaluation.This application will only be applied at the beginning of the exercise program.After the 8-week program, only face-to-face evaluation will be made.
15768941|NCT04704557|Device|geko Neuromuscular Electro Stimulator (NMES)|Neuromuscular Electro Stimulator (NMES)
15768943|NCT04704531|Drug|Sodium Hyaluronate Ophthalmic 0.4% BID|Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno BID.
15768944|NCT04704531|Drug|Sodium Hyaluronate Ophthalmic 0.4% QID|Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno QID.
15768945|NCT04704531|Drug|Sodium Hyaluronate Ophthalmic 0.4% Six times per day|Topical ophthalmic administration of one drop of Multidose Lagricel® Ofteno six times per day.
15768946|NCT04704518|Drug|Sodium Hyaluronate Ophthalmic 0.4%|Topical ophthalmic administration of one drop of Lagricel® Ofteno PF QID.
15768947|NCT04704518|Drug|Trehalose 3% / Sodium Hyaluronate Ophthalmic 0.15%|Topical ophthalmic administration of one drop of Thealoz® Duo QID.
15768950|NCT04704492|Drug|Biological: SM03|Biological: SM03 600 mg or 900 mg intravenous (IV) on week 0,2
15768951|NCT04704479|Device|Russian current|For application of Russian current, 2 channels with 2 electrodes each will positioned on the oblique muscles and rectus abdominis motor points using wet spongy pads to enhance electrical activity. Russian current will be a carrier frequency 2500 Hz with frequency of 5 Hz for 5 minutes of muscular conditioning, 40 Hz for 10 minutes for training of slow contraction muscular fibers and 120 Hz for 5 minutes for training of fast contraction muscular fibers with On time (contraction time) 4 secs and Off time (relaxation time) 2 secs. The contraction phase will be at time of patient's expiration while relaxation will be at time of patient's inspiration
15768952|NCT04704479|Device|EMT|patients in both groups trained 3 times a week, each session consisting of 1/2 h by the end of sessions. Initially, repeated cycles of 3 min of work followed by 2 min of rest were conducted (total work- time 18 min). The length of work intervals was increased on a weekly basis while rest periods were shortened to obtain a total work time of 30 min in the last week of the program. The valve opening pressure was continuously monitored at the mouthpiece to ensure the achievement of the target pressure. Patients will receive EMT with a threshold expiratory muscle trainer (Threshold; HealthScan), started breathing through the expiratory port of the threshold muscle trainer at a resistance equal to 15% of their Pemax for 1 week. The resistance will then increase incrementally, 5 to 10% each session, to reach 60% of their baseline Pemax at the end of the first month then continued at 60% of the Pemax, will be adjusted weekly to the new Pemax achieved
15768953|NCT04704453|Drug|Capsaïcin patch (Qutenza®)|Treatment by application of capsaicin 8% (Qutenza®) patches 3 months apart (Month 1, Month 4 and Month 7).
15768954|NCT04704453|Drug|Amitriptyline (Laroxyl®)|Treatment by amitriptyline (oral solution 40mg/ml), for 9 months at the recommended dose of 25 mg to 75 mg daily.
15768955|NCT04704440|Other|Normobaric hypoxia (FiO2 15%)|"Inhalation of deoxygenated air through an altitude simulator (Altitrainer), for approx. 1/2 hour given by a facemask, first at rest and then during exercise."
15768956|NCT04704440|Other|Placebo-ambient air (FiO2 21%)|"Inhalation of room air through an altitude simulator (Altitrainer), for approx. 1/2 hour given by a facemask, first at rest and then during exercise."
15768957|NCT04704440|Other|Normobaric hypoxia (FiO2 15%) under Sildenafil|"Inhalation of deoxygenated air through an altitude simulator (Altitrainer), for approx. 1/2 hour given by a facemask, first at rest and then during exercise."
15768958|NCT04704440|Other|Placebo-ambient air (FiO2 21%) under Sildenafil|"Inhalation of room air through an altitude simulator (Altitrainer), for approx. 1/2 hour given by a facemask, first at rest and then during exercise."
15768959|NCT04704427|Device|Non-invasive BCI training|In the experimental group, the participants receive non-invasive rehabilitative BCI training. The training using the lower limb orthosis targeted the patient's ability to walk.
15768960|NCT04704427|Other|Traditional Physiotherapy protocol|In the control group，the participants receive the traditional physiotherapy protocol, including muscle strength training, balance training and walking training, etc.
15768961|NCT04704414|Device|Exophthalmos measurement|Exophthalmos measurement with iPhone 11 vs Artec Space Spider 3D Scanner vs Hertel Exophthalmometer.
15768962|NCT04704401|Other|Questionnaire|Structured questionnaire to collect cardiovascular and metabolic events, incident cancers and deaths that have occured, as weel as information on CPAP, through telephone interview.
15768963|NCT04704375|Device|Bio Electro-Magnetic Regulation (BEMER) Therapy|BEMER is a therapeutic modality that deploys a biorhythmically defined stimulus through Pulsed Electromagnetic Field (PEMF). This stimulus has a targeted effect on the microvasculature, and the primary effect is an improvement in tissue microcirculation. The positive effects of vasomotion on the microcirculation has been shown to result in significant increases in arteriovenous oxygen difference, number of open capillaries, arteriolar and venular flow volume, and flow rate of red blood cells in the microvasculature. Therefore, BEMER can potentially be used in the treatment of LBP by improving microcirculation in muscular tissue.
15768964|NCT04704375|Procedure|OMT (osteopathic manipulative treatment)|i. OMT Myofascial release (MFR), soft tissue (ST) release, muscle energy (ME), counterstrain (CS), and balanced ligamentous tension (BLT) technique.
15769018|NCT04703959|Other|polysomnography|polysomnography is already done for all patients
15769199|NCT04702360|Drug|ELX/TEZ/IVA|Fixed-dose combination tablet for oral administration.
15768965|NCT04704375|Procedure|Light touch|Treaters will place their hands lightly on the subject's lumbar paraspinal muscles in the supine and prone positions in the same area as where one would place your hands for lumbar MFR technique for the same amount of time as it would take to perform MFR in this area (approximately 5 minutes). However, no lifting or action will be done. In addition, the subject will lie down on the BEMER mat (as they would do during a BEMER session), but the device will not be activated.
15768966|NCT04704362|Behavioral|Ensuring Quality in Psychological Support|Trainees are evaluated with the Enhancing Assessment of Common Therapeutic factors structured role play tool and the results are shared with trainers and/or supervisors to modify training based on strengths and weakness on the competency scores.
15768967|NCT04704362|Behavioral|Standard Training and Supervision|Trainees are trained using a manual for non-specialist-delivered psychological interventions.
15768968|NCT04704349|Radiation|Scintigraphy|The scintigraphy of the patients will be carried out on 2 distinct devices and the images obtained will be compared.
15768969|NCT04704336|Behavioral|Task-shifting strategy for HTN control (TASSH) protocol|The TASSH protocol include the following 4 steps: 1). Identify HIV patients with uncontrolled HTN: trained HIV nurses will take patients' medical history (whether or not they have a diagnosis of diabetes, heart attack, stroke, heart failure, smoking). 2) Next, they will measure the patients' weight, height, waist circumference and BP with a valid automated device following standard procedures and then conduct lab tests with point-of-care testing on blood glucose, lipids and urine dip stick. 3) Initiate lifestyle counseling and medication treatment every 1-3 months: The nurses will next counsel eligible patients on lifestyle behaviors for 20 to 30 minutes (increased intake of fruits and vegetables, moderate physical activity and reduce salt intake). 4). Refer patients with complicated HTN to physicians for further care
15768970|NCT04704323|Drug|CAP-100|CAP-100 (humanized antibody against C-C-chemokine receptor 7 [CCR]7)
15768971|NCT04704310|Behavioral|Enhancing exercise training for adults with COPD: The roles of peers and functional tasks|A proof-of-concept online 8-week exercise training program for adults with COPD that incorporates both a peer mentorship and a functional tasks component.
15768972|NCT04704297|Drug|Treatment of Myofascial Pain Syndrome in the low back. This intervention will be based on outcomes of the medications listed below.|We are testing which of the three arms is superior for the treatment of Myofascial Pain Syndrome of the Low Back. Pain will be measured using a 10 cm visual analogue scale (VAS) at baseline and 30-minutes after treatment.
15768973|NCT04704297|Drug|Evaluation of functional ability using a patient centered functional score known as the Modified Oswestry Disability Index (MODI). The intervention will be based on outcomes of medications below.|Evaluation of functional ability using a patient centered functional score known as the MODI. The MODI will be scored at baseline and 30-minutes after treatment.
15768974|NCT04704297|Drug|Following up with participants 60-72 hours after treatment in the Emergency Department. This intervention will be based on outcomes of the medications listed below.|60-72 after treatment in the Emergency Department, a member of the study team will follow up with participants to repeat a measurement of pain and functional ability on VAS and MODI respectively. This will be compared to baseline measurements.
15768975|NCT04704284|Diagnostic Test|Zero Echo Time Magnetic Resonance Imaging (ZTE MRI)|Magnetic Resonance Imaging (MRI) with zero echo-time (ZTE) that uses proton density differences rather than T2 relaxation time differences to achieve contrast.
15768976|NCT04704271|Drug|Inhaled THC|4 mg inhaled THC
15768977|NCT04704271|Drug|Placebo|Inhaled placebo (no active cannabinoids)
15768978|NCT04704258|Procedure|TAVI (Transcatheter Aortic Valve Implant)|Placement of a filter to capture and remove emboli or debris detached during any transcatheter heart procedures
15768979|NCT04704258|Device|TAF System|Transcatheter Antiembolic Filter (TAF)
15768980|NCT04704245|Drug|epidermal growth factor (EGF)-containing ointment|The subjects applied the epidermal growth factor (EGF) ointment twice daily (morning and evening) to the lesion for 4 weeks after laser treatment.
15768981|NCT04704245|Drug|Vehicle ointment|To compare the effect of epidermal growth factor (EGF) ointment, the control subjects applied the vehicle ointment twice daily (morning and evening) to the lesion for 4 weeks after laser treatment.
15768982|NCT04704245|Procedure|Q-swithced (QS) 532-nm Nd:yttrium aluminum garnet (YAG) laser|"The subjects received one session of laser treatment with a Q-swithced (QS) 532-nm Nd:yttrium aluminum garnet (YAG) laser of their solar lentigines after enrollment.
~The procedure parameters were as follows: 5-10-ns pulse duration, 3.5-mm spot size, 0.9-1.1-J/cm2 fluence, and 2-Hz frequency.
~The end point of laser treatment for lentigines was immediate whitening."
15768983|NCT04704232|Drug|ACD440|Double blind, parallel within subject comparison
15768984|NCT04704219|Biological|Pembrolizumab|Pembrolizumab 400 mg, every 6 weeks (Q6W) intravenous (IV) up to 18 infusions or up to progressive disease or discontinuation.
15768985|NCT04704219|Drug|Lenvatinib|Lenvatinib 20 mg, daily (QD), oral, until progressive disease or discontinuation.
15768986|NCT04704206|Other|Children will perform activities on interactive tablet|"The main difference between the types of interventions is the mode of use and the level of interactivity of the interactive media, where the AIMG actively performs activities, that is, there is user interaction with the equipment through touch or verbal response and the performance of activities like rotating an object, dragging and zooming. PIMG is not the same, the user is just a spectator, having contact with the equipment only when switching on / off, choosing the content, performing activities such as increasing / decreasing the volume and touching certain specific objects such as giving play / pause . Both groups will have a total of 48 intervention sessions."
15768987|NCT04704193|Other|Survey of Decision Aid|The decision aid will be evaluated by a survey administered to those who have used the tool.
15769019|NCT04703946|Other|observacional|"Analyze the incidence of short sublingual frenulum in newborns of the Hospital Nostra Senyora de Meritxell of the Principat of Andorra.
~Association or not of the AG with auxological parameters (weight, height, cranial perimeter) at birth.
~Association or not of the AG with sex.
~Association or not of the AG with gestational age.
~Association or not of the AG with other minor and major malformations."
15769020|NCT04703933|Other|EVALUATION OF THE LEVEL OF KNOWLEDGE AND ATTITUDE OF THE OPERATING ROOM NURSES|This descriptive study was conducted with 100 nurses working in the operating room of two university hospitals in Istanbul
15769021|NCT04703920|Drug|Talazoparib|Talazoparib will be administered in increasing doses up to 1 mg orally once a day.
15769200|NCT04702360|Drug|IVA|IVA monotablet for oral administration.
15768988|NCT04704180|Behavioral|Facilitation Tuchking Position|The nurse placed the neonate in the facilitated tucking position by rolling up a sizeable sterile towel in a U-shape and covering it with covers available in the unit and then placed the neonate in a supine position. The physiological parameters at admission and in the 15th and 30th minutes of facilitated tucking were recorded. In the 30th minute of facilitated tucking, the researcher and the observer nurse completed the COMFORTneo simultaneously but separately. The neonate was in the facilitated tucking position until delivered to its mother. The researcher and the observer nurse had a full view of the neonate's face and body when completing the COMFORTneo, which took them about two minutes. After the neonate stabilized (within the first half an hour to an hour), it was delivered to its mother for breastfeeding based on specialist consent. The first breastfeeding was performed and completed the LATCH by researcher and the observer nurse.
15768989|NCT04704167|Other|fixation of double barrel vascularised fibula|3D titanium miniplate or 3D titanium mesh tray are used as a method of fixation for double barrel vascularized fibula
15768992|NCT04704141|Drug|Hormone replacement therapy|A hormone replacement regimen using any medication of a number of standard treatment options
15768993|NCT04704128|Other|Salivic sample|Collection of total saliva not stimulated
15768994|NCT04704102|Behavioral|Muscle energy technique (MET)|A manual therapy technique that uses the gentle muscle contractions of the patient to relax and lengthen muscles and normalize joint motion.
15768995|NCT04704102|Behavioral|Strain-counterstrain (SCS)|"It's also called the positional release technique, a manual therapy technique that passively positions the hypertonic (spasmed) muscles and dysfunctional joints in positions of shortened or comfort."
15768996|NCT04704102|Behavioral|sham SCS|SCS intervention that position with opposite site limb and direction, and with modified method as consider the easiness of a practitioner to press the tender points
15768997|NCT04704089|Other|spectrophotometer|"Calibration of the spectrophotometer (calibration of white and green color on the provided support),
~Placing the patient or witness in the chair,
~Placement of intraoral retractors,
~Photographs of the dental arch in occlusion as well as slightly open mouth to visualize the mandibular incisors,
~If MIH is suspected, occlusal images of the occlusal surfaces of the first molars will be taken with the help of a dental mirror,
~Shooting with the spectrophotometer centered on each of the teeth of interest in the anterior sector with verification of the good quality of the shot according to the axis (validated in green on the camera),
~Backup of images with coded identification number"
15768998|NCT04704089|Other|Biological (protein analysis by western blot or mass spectrometry of matrix proteins), structural (electron microscopy) and physico-chemical analyses|"Chemical analysis of enamel mineral.
~Techniques of spectrometry and spectroscopy (Raman and FTIR)
~Atomic Probe Tomography and Protein Mass Spectrometry (ICP-MS)."
15768999|NCT04704076|Other|ESVS|Breastfeeding with up to 59-mL formula daily for the first 30 days, followed by exclusive breastfeeding through 6 months of age
15769000|NCT04704076|Other|Exclusive breastfeeding|Breastfeeding exclusively without any other food or fluid except vitamins, minerals and medications through 6 months of age
15769001|NCT04704063|Drug|Tocotrienols / Vitamin E|Palm Tocotrienols complex
15769002|NCT04704063|Drug|Placebo control|Placebo matching Tocovid Suprabio
15769003|NCT04704050|Drug|dronedarone 400 mg Oral Tablet|"Dronedarone is an anti-arrhythmic drug with properties belonging to Vaughan-Williams class I-IV.
~Participants will receive dronedarone 400 mg tablet, to be taken orally and twice daily for 52 weeks."
15769004|NCT04704050|Drug|Placebo|Participants will receive a placebo tablet matching the physical appearance of dronedarone, to be taken orally and twice daily for 52 weeks.
15769005|NCT04704037|Other|Guideline implementation tool|Family physicians will receive a tailored letter with their patient's mental health screening test results and associated mental health treatment recommendations from the Ontario Neurotrauma Foundation guidelines, as well as a list of mental health treatment resources. In addition, the patient will receive a written information package about mental health problems after mTBI and treatment options to discuss with their family physician.
15769006|NCT04704037|Other|Generic information about concussion management|Family physicians will receive a generic letter drawing their attention to Canadian clinical practice guidelines for mild Traumatic Brain Injury (developed by the Ontario Neurotrauma Foundation). Patients will receive instructions about how to access generic education materials about mTBI (from concussion.vch.ca/), which they should have received anyway as part of usual care.
15769007|NCT04704024|Drug|Tenofovir Disoproxil Fumarate|oral TDF medication 300 mg daily
15769008|NCT04704024|Drug|Lamivudine Oral Solution|Oral lamivudine with weight-based dosing BID from birth until 6 months of age
15769009|NCT04704011|Other|2-1-1 United Way Healthy Missouri Hotline|This federally funded, free service connects callers with appropriate community services to help address their unmet basic needs.
15769010|NCT04704011|Other|National Comprehensive Cancer Network (NCCN) Distress Thermometer|Study participants will be asked to rate the amount of distress that they have experienced in the past week (scale of 0 to 10, 10=extreme distress) and indicate areas of concern including practical basic needs and family, emotional, spiritual, and physical problems. They will also be asked to rate the amount of distress (scale 0-10) that they attribute to their abnormal cervical cancer screen.
15769011|NCT04704011|Other|Basic needs survey|11-item survey with questions regarding safety, housing, food, and financial needs
15769012|NCT04704011|Other|2-1-1 survey|This brief, 5-minute survey will be performed either in person or by phone after the participants arrive to their colposcopy appointment or after 6 weeks of their scheduled visit if they are nonadherent. The research team will ask patients regarding any changes in the status of their unmet basic needs (resolved, improved, worsened, or stayed the same) and how useful they found the 2-1-1 resource.
15769013|NCT04704011|Other|Usual Care Reminder Call|-Automated phone call two weeks before their colposcopy appointment
15769014|NCT04703998|Procedure|Arthroscopic rotator cuff repair|A double-row rotator cuff repair will be performed.
15769015|NCT04703998|Biological|platelet rich plasma|A single dose of 10 ml of autologous platelet rich plasma at the bone-tendon interfase will be administered.
15769022|NCT04703920|Drug|Belinostat|Belinostat will be administered in increasing doses up to 1000 mg/m2 IV once daily on days 1-5 of a 21-day cycle.
15769023|NCT04703907|Other|Auricular stimulation|"Auricular acupuncture-like stimulation (percutaneous sensory stimulation of cranial nerves)"
15769024|NCT04703894|Dietary Supplement|AYMES 'CARDIFF'|AYMES CARDIFF is a Food for Special Medical Purposes (FSMP) and must, therefore, be used under medical supervision. It is not designed as a sole source of nutrition.
15769025|NCT04703881|Dietary Supplement|AYMES ActaGain|AYMES ActaGain is a Food for Special Medical Purposes (FSMP) and must, therefore, be used under medical supervision. It is designed as a supplement to the diet but can also be used as a sole source of nutrition.
15769026|NCT04703868|Drug|Rabeprazole Sodium 10mg|Part A: 1 tablet administered before the breakfast during 7 days
15769027|NCT04703868|Drug|Rabeprazole Sodium 20mg|Part B: 1 tablet administered before the breakfast during 7 days
15769028|NCT04703855|Device|HeartMate 3™ left ventricular assist system (HM3 LVAS)|Advanced heart failure patients will be implanted with the HM3 LVAS
15769029|NCT04703842|Biological|SRD-001|AAV1/SERCA2a
15769030|NCT04703842|Drug|Placebo|SRD-001 matching placebo
15769031|NCT04703816|Other|Interpersonal Skills Multifaceted Training Program for the physician-patient relationship|The training program consisting of two half-day group workshops with a review of the skills needed to build effective patient relationships and a discussion of difficult consultations based on communication theory like Process-Com® and the Four Habits Model.
15769032|NCT04703803|Combination Product|1% lidocaine injection in trigger points|The trigger point injection procedure with 1% lidocaine will be e (the sum of all needled trigger points will have a maximum of 10 ml), in a single intervention
15769033|NCT04703764|Drug|HSG4112|once-daily, 14-day multiple oral administration
15769034|NCT04703764|Drug|HSG4112 Placebo|once-daily, 14-day multiple oral administration
15769035|NCT04703751|Device|Transcoronary delivery of a pharmacological agent (nitroglycerin) and cell based agent (Cardiocell) using the CIRCULATE Catheter|Investigated device - the CIRCULATE Catheter will be introduced, using a standard radial or femoral access and a typical guiding catheter and typical coronary wire, first into the right coronary artery. After that the one dose of NTG (200µg) will be administered followed by a typical angiographic recording to visualize the vasodilatatory effect of the medication. Then CardioCell in doses of 10mln cells each (6.7mL) will be administered transcoronary to each of the coronary arteries (right coronary artery (RCA), LAD, left circumflex (Cx)). Angiography will be performed routinely before and after each product administration.
15769036|NCT04703738|Procedure|Soft tissue flap + Connective Tissue Graft|The treatment site is accessed using a full thickness flap extending at least 1 full tooth mesial and distal, vertical releasing incisions may be used to obtain flap release for full coverage of the treatment site and graft without compression. The harvest graft donor area will be the palate in the bicuspid region on the same side as the control soft tissue augmentation therapy. The CTG will be harvested using full thickness incisions that include the periosteum and will be closed using suture and coating the incision line with a tissue adhesive. No covering stents or packs should be employed. The CTG will be sling sutured in place and the flap secured using a double sling suturing technique.
15769037|NCT04703738|Device|Soft tissue flap + Geistlich Fibro-Gide®|The treatment site is accessed using a full thickness flap extending at least 1 full tooth mesial and distal, vertical releasing incisions may be used to obtain flap release for full coverage of the treatment site and matrix without compression. Geistlich Fibro-Gide® is cut to shape to the treatment site and placed dry into the site. The flap is secured using a double sling suturing technique.
15769038|NCT04703725|Behavioral|Psychosocial Care|"First Follow-Up: One of the implementation of the module
~Second Follow-up: Implementation of the second module; Breathing Exercises and EFT
~Third Follow-up: Emotional preparation about egg pick up process, individual application of coping methods
~Fourth Follow-up: Implementation of the second module; Briefing about Breathing Exercises and EFT embryo transfer process
~Fifth Follow-up: Implementation of the second module; Breathing Exercises and EFT
~Sixth Follow-up: Individual application of coping methods until the learning process of pregnancy test result
~Seventh Follow-up: Providing information about the first periods of pregnancy after treatment resulting in pregnancy and providing information about the psychosocial problems that may be encountered. Identifying psychosocial problems that may be encountered after unsuccessful treatment and individual application of coping methods to help cope."
15769039|NCT04703712|Procedure|Lens extraction combined with goniosynechialysis|The patients enrolled underwent phacoemulsification combined with goniosynechialysis surgery.
15769040|NCT04703712|Procedure|Trabeculectomy surgery|The patients enrolled underwent trabeculectomy surgery
15769041|NCT04703699|Device|Myval Transcatheter Heart Valve System|Myval™ THV is a newer-generation balloon-expandable THV characterized by a nickel-cobalt alloy frame composed of a single element - hexagon arranged in a hybrid honeycomb fashion.
15769042|NCT04703686|Drug|Obinutuzumab|1000mg - prephase - one infusion at D-3
15769043|NCT04703686|Drug|RO7082859|2.5 mg D1C1, 10 mg D3C1, then 30 mg D8C1 and D1 every 21 days (C2-C11, D1C2 starts 14 days after D1C1)
15769044|NCT04703673|Drug|Cineole|self administration according to directions for use
15769045|NCT04703673|Drug|Nasal Decongestant|self administration according to directions for use
15769046|NCT04703660|Procedure|cervical mobilization|3 types of cervical mobilization at the level of C 5- 6
15769047|NCT04703647|Other|Administration of questionnaires for prospective group|Questionnaires: administration at T0, T1,T2,T3 and T4 of Short Form Health Survey (SF-36),Brief Pain Inventory (BPI),Disabilities of the Arm, Shoulder and Hand (DASH) for upper limb,Foot and Ankle Ability Measure (FAAM) for lower limb,Hospital Anxiety And Depression Scale (HADS),Tampa Scale of Kinesiophobia (TSK),Pain Catastrophizing Scale (PCS),Pattern Of Activity Measure - Pain (POAM-P) .
15769048|NCT04703647|Other|Blood samples for prospective group|Blood samples at T0,T1,T2 and T3.
15769049|NCT04703647|Other|Blood samples for control group|Blood samples just one time
15769050|NCT04703634|Procedure|erector spinae block (ESP)|Administration of local anesthetic under the erector spinae muscle just below the transverse process of the thoracic 12th vertebra
15769051|NCT04703621|Drug|Daratumumab Injection|subcutaneious daratumumab administration
15769052|NCT04703608|Drug|Ivermectin|Ivermectin 0.3-0.4mg/Kg daily for 3 days.
15769053|NCT04703608|Drug|ASP|Aspirin 150mg daily for 28 days or until hospital discharge (whichever is sooner)
15769055|NCT04703595|Genetic|To determine the presence of biallelic expansion of AAGGG in RFC1 in patients with chronic cough, regardless of the presence of neurological symptoms.|"To determine the presence of biallelic expansion of AAGGG in RFC1 in patients with chronic cough, regardless of the presence of neurological symptoms.
~For the molecular study of the DNA sample of the patients, two techniques will be used: standard Polymerase chain reaction amplification with primers flanking the intron 2 fragment of the RFC1 gene and amplification using Repeated Primed Polymerase chain reaction in 3 independent reactions."
15769056|NCT04703582|Diagnostic Test|Activated clotting time|Relationship between elongated baseline activated clotting time and comorbidity
15769057|NCT04703569|Procedure|Dressing with monolayer high compression elastic bandage|The nurse will be apply the therapy high compression elastic bandage once a week, during 26 weeks
15769058|NCT04703569|Procedure|Dressing with Unna boot|The nurse will be apply the therapy Unna Boot once a week, during 26 weeks.
15769059|NCT04703556|Device|Devices for deep brain stimulation|Effect of DBS parameters (amplitude, frequency) on gait and balance deficits, and their dynamical evolution over a pre-defined time
15769060|NCT04703543|Device|Pilot evaluation study on use PSMA and Cu-PET/CT|This study aims at assessing the detection rate of both PSMA and Cu-PET/CT on tissue relapse, study whether this method is equivalent to mpMR
15769061|NCT04703530|Other|hot footbath|The experimental group was given a hot footbath with a temperature of 41℃±1℃ for 20 minutes at about 1-2 hours before sleep
15769062|NCT04703517|Diagnostic Test|Point of care ultrasound|Patients will receive a point of care ultrasound at the bedside in the Emergency Department and compare the impression to the x ray result
15769063|NCT04703504|Other|Multiple intervention program|Support for patient follow-up assisted by a computer program
15769064|NCT04703491|Behavioral|Interactive and full-featured intervention|Participants will go through an automated program. Participants will learn and practice the techniques of CBT through multimedia elements. They will play games based on Cognitive Bias Modification (CBM) paradigms, practice mindfulness, and chat with an automated empathic chatbot.
15769065|NCT04703491|Behavioral|Feature-limited CCBT|Participants will be going through an automated program. Participants will learn and practice the techniques of CBT in a plain-text format with reduced features
15769066|NCT04703491|Other|Waitlist control|Participants will be put on a waitlist for a period of 6 weeks.
15769067|NCT04703478|Other|Breathing exercise|Participants will carry out a breathing exercise program through the RespiraConNosotros mobile application. They will be asked to carry out the proposed exercises with a frequency of 3 times a week for 3 months.
15769068|NCT04703465|Drug|Tenofovir Alafenamide 25 MG|Tenofovir Alafenamide 25mg for 48 weeks will be delivered
15769069|NCT04703452|Other|Indicators of central sensitisation|Indicators of central sensitisation, assessed by the Central Sensitization Inventory
15769070|NCT04703439|Behavioral|Medication-taking reminders & educational materials|The intervention has been described in arm/group descriptions, which lasted for 60 days for each participants.
15769071|NCT04703439|Behavioral|Educational materials|The intervention has been described in arm/group descriptions, which lasted for 60 days for each participants.
15769072|NCT04703426|Drug|Sargramostim (GM-CSF)|Drug that binds to the protein PD-1 to help immune cells kill cancer cells better, it is given as an intravenous injection through a vein.
15769073|NCT04703426|Drug|Pembrolizumab (anti-PD-1)|Drug that stimulates blood cells that may help support the immune system during cancer treatment, given as intravenous infusion
15769074|NCT04703413|Device|LoFric® OrigoTM and LoFric® SenseTM|The investigational device is either a CE-marked LoFric® OrigoTM , 40 cm, CH12/CH14 or LoFric® SenseTM, 15 cm, CH12. They are all intermittent urinary catheters with a Nelaton tip from a more sustainable manufacturing process. All subjects will use the investigational device for 30 days each.
15769075|NCT04703400|Other|anonymous survey|anonymous survey with 25 mandatory questions
15769076|NCT04703387|Diagnostic Test|transthoracic echocardiography|Trans-mitral flow velocities (peak early diastolic E and peak late diastolic A) will be recorded with pulsed-wave Doppler, placing the sample volume at the mitral valve tips from the apical 4-chamber view; deceleration time of the E wave (DTE) will be measured. Peak early diastolic velocity will be obtained with tissue Doppler imaging (TDI), in the apical 4-chamber view, positioning the pulsed-wave Doppler sample volume at or 1 cm within the septal insertion sites of the mitral leaflets, so as to cover the longitudinal excursion of the mitral annulus in both systole and diastole. Then, the E/A ratio and the trans-mitral inflow E wave to mitral annular e' (E/e) will be calculated.Diaphragmatic thickness will be assessed in the zone of apposition of the diaphragm to the rib cage between the 8th and 10th intercostal spaces using a 3-12 MHz linear array probe , we will record changes in diaphragm vertical excursion using M-mode ultrasound.
15769077|NCT04703374|Drug|CKD-382(formulation I)|1 tablet administered under fasting condition for 7days
15769078|NCT04703374|Drug|CKD-382(formulation II)|1 tablet administered under fasting condition for 7days
15769079|NCT04703374|Drug|D026|1 tablet administered under fasting condition for 7days
15769080|NCT04703361|Biological|Placebo NaCl|Placebo
15769081|NCT04703361|Biological|Niacin|B3 vitamin, Niacin
15769082|NCT04703361|Biological|Na-3-OHB|Na-3-OHB
15769083|NCT04703348|Diagnostic Test|Motor imagery Questionnaire - Revised Second (MIQ-RS)|"Patients fulfill a questionnaire measuring individuals capacities to realize mental imagery. For more facilities and less risk of bias, the MIQ-RS was written on an online version with questions recorded in audio format. No official cut-off exists but studies seem to prove that people with :
~a score less than 48/98 are unable to do motor imagery
~a score between 49 and 73/98 have disturbed motor imagery capacities
~a score more than 74/98 have normal motor imagery capacities."
15769084|NCT04703335|Drug|Antimicrobial efficacy of gel ZHCK4 as a patient preoperative skin preparation|Evaluate the antimicrobial efficacy of two concentrations of one patient preoperative skin preparation product compared to a positive control (2.0% chlorhexidine gluconate) and negative control (physiological saline 0.9% solution). Following a 14-day restriction period, subjects will be sampled for baseline, 10-minutes, 6-hours, and 24-hours microbial reduction evaluations post-product application. Subjects will not be sequestered for the 6-hour or 24-hour evaluations. Test day baseline criteria will be set at: abdomen: ≥ 3.0 log10 CFU/cm2, and inguen: ≥ 5.0 log10 CFU/cm2.
15769085|NCT04703322|Drug|Pexidartinib|400 mg twice daily for a total daily dose of 800 mg (each capsule contains 200 mg of pexidartinib for oral administration)
15769086|NCT04703296|Behavioral|MBAT course|"The MBAT will involve:
~(i) 4 weekly 2-hour course sessions. The sessions will provide guided exercises, didactic information, and discussions to promote greater mindfulness.
~(ii) Daily mindfulness practice that will be facilitated by the Measuring Mindfulness App (MMA) and/or instructor-delivered mindfulness practices. The daily mindfulness practice will require about 15 minutes to complete."
15769087|NCT04703283|Behavioral|Lifestyle Medicine|Lifestyle intervention with components including exercise, diet, stress management, and sleep management
15769088|NCT04703257|Drug|Metamizole|Patients in the experimental group will be instructed to take metamizole 1000 mg orally three times a day for four days patients will be instructed to take 1000 mg paracetamol orally four times a day for four days. .
15769089|NCT04703257|Drug|Placebo|Patients in the control group will be instructed to take a placebo tablet three times a day for four days and patients will be instructed to take 1000 mg paracetamol orally four times a day for four days.
15769090|NCT04703244|Procedure|chemotherapy or endocrine therapy for breast cancer|Collect blood and leftover surgical tissue from patients with breast cancer remaining after chemotherapy or endocrine therapy is completed.
15769091|NCT04703231|Diagnostic Test|measurement of macular thickness, corneal thickness and lens opacities|The incidence of macular thickness, Corneal thickness, intraocular pressure and lens opacities will be investigated by an ophthalmologist.
15769092|NCT04703218|Other|olfactory rehabilitation|Olfactory rehabilitation consists of smelling 4 scents twice a day using scent sticks, for 12 weeks
15769096|NCT04703179|Other|Genetic test evaluation|Patients with rare and undiagnosed disease and their family members may be evaluated on a case by case basis. The research study may perform multi-omics testing to provide a diagnosis or to provide biomarker discovery.
15769098|NCT04703140|Diagnostic Test|Rapid Diagnostic Test vs PCR|2 nasopharyngeal swabs taken for PCR and COVIDISC
15769099|NCT04703127|Drug|Tadalafil and Combined Dapoxietine|Group 1 was given on-demand 30 mg dapoxetine and 10 mg tadalafil 1 h before intercourse.
15769100|NCT04703127|Drug|Dapoxietine and Combined Lidocaine 5% Spray|Group 2 was given on-demand 30 mg dapoxetine 1 h before intercourse and apply lidocaine 5% spray on the glans penis 10 minutes the wash before intercourse.
15769101|NCT04703114|Diagnostic Test|Blood count|Blood count at each visit
15769102|NCT04703114|Diagnostic Test|Blood collection|Blood collection to understanding of the immunological profile at each visit
15769103|NCT04703114|Diagnostic Test|Nasopharyngeal swab|Research of SARS-CoV-2 infection in nasopharyngeal swab by RT-PCR at day 8 and day 15
15769104|NCT04703114|Diagnostic Test|Saliva samples|Research of SARS-CoV-2 infection in saliva samples at each visit (excepted inclusion)
15769105|NCT04703114|Diagnostic Test|Faeces samples|Research of SARS-CoV-2 infection in faeces samples at day 3, day 15 and day 90
15769106|NCT04703114|Genetic|Genetic blood collection|Collection to further research at each visit
15769107|NCT04703114|Other|Data collection|Demographics, symptoms, biological constants
15769108|NCT04703101|Drug|Capecitabine|Given IV
15769109|NCT04703101|Drug|Fluorouracil|Given IV
15769110|NCT04703101|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
15769111|NCT04703101|Drug|Leucovorin|Given IV
15769112|NCT04703101|Drug|Oxaliplatin|Given IV
15769113|NCT04703101|Other|Quality-of-Life Assessment|Ancillary studies
15769114|NCT04703101|Behavioral|Surveillance|Undergo NOM
15769115|NCT04703101|Procedure|Total Mesorectal Excision|Undergo TME
15769116|NCT04703088|Drug|Ondansetron 4 MG|2 mL of a solution of Ondansetron containing 2mg/ml in a 3 ml syringe will be given intravenously to a patient five minutes before positioning for induction of spinal anesthesia
15769117|NCT04703088|Drug|0.9% Saline|2 mL of 0,9% Saline in a 3 ml syringe will be given intravenously to a patient five minutes before positioning for induction of spinal anesthesia
15769118|NCT04703075|Drug|Rifapentine 600 mg and INH 300 mg|Participants will receive Rifapentine 600 mg and INH 300 mg
15769119|NCT04703075|Drug|Rifapentine 900 mg and INH 900 mg|Participants will receive Rifapentine 900 mg and INH 900mg
15769120|NCT04703062|Behavioral|Experimental group 1|It is planned to do exercises for 50 minutes a day, 2 days a week during 8 weeks with physiotherapist. It will be planned individually according to the needs of the patients. Exercises will progress in the following weeks by changing the number of repetitions, the amount of resistance and the amount of time. Counseling about physical activity and the suggested sports activity will be provided. In daily living activities ergonomics and joint protection principles will be taught. Informing Family.
15769121|NCT04703062|Behavioral|Experimental group 2|Counseling about physical activity and the suggested sports activity will be provided.Patients make aerobic and strengthening exercises by himself based on physiotherapist's suggestions. Informing Family about; Why are the exercises necessary To what extent the families should be protective The harmful effects of inactivity There will be information about the resting-activity cycle when there is bleeding.
15769122|NCT04703049|Other|Blood Viscosity Testing|we calculated WBV using the formula [(0.12 × hematocrit) + (0.17 × (total protein - 2.07)]. We defined CIN as the absolute (≥0.5 mg/dl) or relative increase (≥25%) in serum creatinine 48-72 h after exposure to a contrast agent compared with baseline serum creatinine values.
15769123|NCT04703036|Dietary Supplement|Glycine|Glycine is an amino-acid (protein)
15769124|NCT04703036|Dietary Supplement|N-acetylcysteine|This is a donor of the amino-acid cysteine (protein)
15769125|NCT04703036|Dietary Supplement|Alanine|Alanine is an amino-acid (protein)
15769159|NCT04702698|Drug|Peposertib|Participants will receive oral suspension dose of peposertib tablets under fasted condition (Treatment C) in either period 1, 2 or 3 of part 1.
15769126|NCT04703010|Device|Electroencephalography-Near infrared spectroscopy|Brain activity will be measured using 128-channel EEG and 2 channel NIRS during tactile stimulation (15 minutes sequence of vibrations) while the newborn is asleep.
15769127|NCT04703010|Device|Magnetic resonance imaging|Structural (T1-T2), siffusion tensor imaging and blood-oxygen level dependant signal will be acquired in a subset of 40 subjects (20 minutes while asleep)
15769128|NCT04703010|Behavioral|Psychometric testing|Cognitive evaluation at age 2 (Parental questionnaires on sensory profiles, executive functions and neurodevelopmental disorders screening, child tests : movement assessment battery, Laby, Head-toes-shoulders-knees)
15769129|NCT04702997|Drug|Bardoxolone methyl oral capsule|Bardoxolone methyl capsules dose escalated from 5 mg to a maximum of 20 or 30 mg, depending on baseline proteinuria status
15769130|NCT04702997|Drug|Placebo oral capsule|Capsule containing an inert placebo
15769131|NCT04702971|Drug|Flunarizine|The flunarizine will be given per clinical routine
15769132|NCT04702971|Other|healthy control|no intervention for healthy control
15769133|NCT04702919|Other|Registration|Synchronized recording of BTP in ultrasound, brain activity by EEG, heart rate and blood pressure.
15769134|NCT04702919|Other|Auditive oddball task|Presentation of an auditory sequence, comprising 'Standard' (probability of occurrence: p = 0.90) and 'Deviants' (p = 0.10, targets) sounds via loudspeakers.
15769135|NCT04702906|Other|standard treatment|Standard treatment if indicated.
15769136|NCT04702906|Drug|"trimetazidine hydrochloride metacardia ® 20 mg tablet"|"trimetazidine hydrochloride metacardia ® (20 mg three times daily produced by Global NAPI Pharmaceuticals-Egypt)"
15769138|NCT04702880|Biological|BMS-986012|Specified dose on specified days
15769139|NCT04702880|Drug|Carboplatin|Specified dose on specified days
15769140|NCT04702880|Drug|Etoposide|Specified dose on specified days
15769141|NCT04702880|Biological|Nivolumab|Specified dose on specified days
15769142|NCT04702854|Diagnostic Test|Ultrasound Biomicroscopy|Measure of cutaneous melanomas by ultrasound Biomicroscopy
15769143|NCT04702841|Drug|Chimeric antigen receptor modified γδ T cells|Dosage: the total dosage of reinfusion is 0.2-5 × 10^6 / kg, which is determined according to the body weight of the subject and the effective content of cell preparation.
15769144|NCT04702802|Device|Sodium hyaluronate 3%|During intraocular surgery phacoemulsification and intraocular lens implantation, patients with age-related cataract will be exposed to injection of viscoelastic device in the anterior chamber, allowing the procedure to take place.
15769145|NCT04702802|Device|Sodium hyaluronate 3%|During intraocular surgery phacoemulsification and intraocular lens implantation, patients with age-related cataract will be exposed to injection of viscoelastic device in the anterior chamber, allowing the procedure to take place.
15769146|NCT04702789|Drug|Dorzolamide-timolol-brimonidine and latanoprost|Application of Gaap Ofteno PF® every 24 hrs for 30 days plus concomitant application of Krytantek Ofteno PF® every 12 hours for 60 days. Total intervention time: 90 days.
15769147|NCT04702789|Drug|Dorzolamide-timolol and latanoprost|Application of Gaap Ofteno PF® every 24 hrs for 30 days plus concomitant application of Eliptic Ofteno PF® every 12 hours for 60 days. Total intervention time: 90 days.
15769148|NCT04702776|Drug|Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%|Application of one drop of Humylub Ofteno® PF (Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) QID in both eyes (OU) during 30 days.
15769149|NCT04702776|Drug|Sodium hyaluronate 0.15%|Application of one drop of Hyabak® PF (Sodium hyaluronate 0.15%) QID in OU during 30 days.
15769150|NCT04702776|Drug|Sodium hyaluronate 0.4%|Application of one drop of Lagricel Ofteno® PF (Sodium Hyaluronate 0.4%) QID in OU during 30 days.
15769151|NCT04702763|Other|Eye-Tracker®T2 + e-VOG|"1st step: eyes movements assessed with standard video-oculography device
~2° step: eyes movements assessed with e-VOG digital application
~Patient study duration is about 30 minutes, the day the patient performs their standard video-oculography examination in routine care"
15769152|NCT04702763|Other|e-VOG + Eye-Tracker®T2|"1st step: eyes movements assessed with e-VOG digital application
~2° step: eyes movements assessed with standard video-oculography device
~Patient study duration is about 30 minutes, the day the patient performs their standard video-oculography examination in routine care"
15769155|NCT04702737|Drug|AMG 757|AMG 757 will be administered as an intravenous (IV) infusion.
15769157|NCT04702711|Other|No intervention|No intervention
15769158|NCT04702698|Drug|Peposertib|Participants will receive single oral dose of Peposertib tablet under fasting (Treatment A) or fed (Treatment B) conditions.
15769161|NCT04702685|Other|Placebo|Bandage will be placed in the presumed injection site while patients in under general anesthesia
15769162|NCT04702672|Dietary Supplement|100% wheat (control)|Intake of 250 ml of tap water and 100 g of bread baked with 100% wheat flour (regular commercial available wheat flour). Consumed over maximum 10 minutes at time 0 min after overnight fasting. At one of four visits.
15769163|NCT04702672|Dietary Supplement|50% HIAMBA®|"Intake of 250 ml of tap water and 100 g of bread baked with 50% HIAMBA® flour and 50% wheat flour. Consumed over maximum 10 minutes at time 0 min after overnight fasting. At one of four visits.
~HIAMBA® are naturally bred in corporation with PlantCarb ApS and researchers at Aarhus and Copenhagen Universities. The wheat flour is standard commercial available flou"
15769164|NCT04702672|Dietary Supplement|75% HIAMBA®|"Intake of 250 ml of tap water and 100 g of bread baked with 75% HIAMBA® flour and 25% wheat flour. Consumed over maximum 10 minutes at time 0 min after overnight fasting. At one of four visits.
~HIAMBA® are naturally bred in corporation with PlantCarb ApS and researchers at Aarhus and Copenhagen Universities. The wheat flour is standard commercial available flour."
15769165|NCT04702672|Dietary Supplement|50% nude barley|"Intake of 250 ml of tap water and 100 g of bread baked with 50% nude barley flour and 50% wheat flour. Consumed over maximum 10 minutes at time 0 min after overnight fasting. At one of four visits.
~Ancient nude barley naturally bred in corporation with PlantCarb ApS and researchers at Aarhus and Copenhagen Universities. The wheat flour is standard commercial available flour."
15769166|NCT04702646|Drug|Bowel preparation before colonoscopy|one day liquid diet will be administered to every patient included in the study and: split-dose bowel preparation with 4 Liters of Polyethylene glycol solution, 2 Liters of PEG-Ascorbic acid or 2 Liters Picosulfate.
15769167|NCT04702646|Procedure|Colonoscopy|colonoscopy will be performed to every patient included in the study
15769168|NCT04702633|Other|Results obtained by biopsy and MRI results.|Results obtained by biopsy and MRI results.
15769169|NCT04702633|Other|Clinical data|Clinical data
15769170|NCT04702620|Device|Ventica® device from Revenio|Measurement of expiratory flow variability for the detection of bronchospasm in infants
15769171|NCT04702607|Procedure|contrast enhanced 4DCT|Functional Lung Imaging with DECT and 4DCT
15769172|NCT04702594|Behavioral|Music therapy session via tools validated by MUSIC CARE|Use of the MUSICARE tool, a digital space allowing access to different validated methods of music therapy. Music listening times are offered to patients with cognitive impairment with psycho-behavioral symptoms. The sessions are individual or group performed by a psychomotor therapist in UHR and volunteer caregivers trained in SRH. The sessions last on average 20-30min.
15769173|NCT04702581|Drug|PCV chemotherapy|"cycle of PCV chemotherapy is given as:
~Day 1: CCNU 110 mg/m2 orally;
~Days 8 and 29: Vincristine 1.4 mg/m2 IV;
~Days 8 to 21: Procarbazine 60 mg/m2 orally
~6 cycles are given."
15769174|NCT04702581|Drug|Radiotherapy and PCV chemotherapy|"Radiotherapy will deliver 50.4 Gy in 28 fractions of 1.8 Gy using IMRT technique.
~Followed by 6 cycles of PCV chemotherapy
~1 cycle of PCV is given as:
~Day 1: CCNU 110 mg/m2 orally;
~Days 8 and 29: Vincristine 1.4 mg/m2 IV;
~Days 8 to 21: Procarbazine 60 mg/m2 orally"
15769175|NCT04702568|Drug|BCX9930|BCX9930 for oral administration
15769176|NCT04702555|Drug|VTS-K|An oral combination drug of VTS-Aspirin and ketamine (VTS-K)
15769177|NCT04702542|Drug|Enteral oxygen therapy|Enteral oxygen therapy during the rehabilitation period of patients with CGDP.
15769178|NCT04702529|Device|Treatment of hypertrophic scars (Soliton's Rapid Acoustic Pulse (RAP) Device)|Administration of 3 Rapid Acoustic Pulse (RAP) treatments
15769179|NCT04702516|Drug|Ozempic|2 mg prefilled pen for subcutaneous injection, 0.25 mg for two weeks then 0.5 mg for two weeks and then 1 mg for another 48 weeks.
15769180|NCT04702516|Drug|Placebo|2 mg prefilled pen for subcutaneous injection, 0.25 mg for two weeks then 0.5 mg for two weeks and then 1 mg for another 48 weeks.
15769181|NCT04702503|Drug|WP1220|Topical administration 2x daily for 84 consecutive days
15769182|NCT04702490|Drug|MET409 Active|MET409 Active (50mg)
15769183|NCT04702490|Drug|MET409 Placebo|MET409 Placebo (50mg)
15769184|NCT04702490|Drug|Empagliflozin|Empagliflozin (10mg)
15769185|NCT04702477|Behavioral|Mindfulness Based Stress Reduction|Mindfulness Based Stress Reduction (MBSR) is a well-documented approach to reduce participants' stress level [19], with the existing group-based peer support, self-empowerment, and lifestyle counseling intervention. MBSR is a type of meditation therapy with the goal of actively cultivating conscious attention and awareness to enhance health benefits. This included 10 hours of intervention with groups of 3-5 people.
15769186|NCT04702464|Drug|Fedratinib|Fedratinib
15769187|NCT04702464|Drug|Fluconazole|Fluconazole
15769188|NCT04702451|Procedure|Dispersion ablation + PVI|Ablation of spatio-temporal dispersion electrograms in combination with pulmonary vein antrum isolation
15769189|NCT04702451|Device|VX1|VX1-based dispersion mapping
15769190|NCT04702451|Procedure|PVI|Pulmonary vein antrum isolation
15769191|NCT04702438|Behavioral|ICT activities|Family interventions using ICT to promote family communication, sharing happiness with family members, and well-being in the community.
15769194|NCT04702412|Other|The Opal patient portal and smartphone application combined with the I-Score patient-reported outcome measure|HIV patients will complete the I-Score PROM via Opal (patient portal) prior to three consecutive clinic visits with their HIV physician who is expected to access their PROM results in time for the visit. The clinic visits will be held at Time 1, Time 2 (3 months) and Time 3 (6 months).
15769195|NCT04702399|Device|GEL GROUP|Application of an anti-adhesion gel (HYALOBARRIER® GEL ENDO) in the uterine cavity
15769196|NCT04702386|Behavioral|Focus groups|Groups of 3 to 8 children led by the study psychologist lasting 1 hour for the 8-11-year-old children and up to 2 hours for the children of at least 12 years old, about being the child of a parent with CF
15769197|NCT04702386|Behavioral|Individual interviews|Interview led by the psychologist about being the child of a parent with CF
15769198|NCT04702373|Other|passive range of motion exercise therapy|Systematic flexion-extension with gentle compression at the end of the movement is performed 10 times at the wrist, elbow, shoulder, ankle, knee, and hip joints. Ten repetitions of adduction-abduction are performed at the shoulder and hip joints.
15835337|NCT04162093|Procedure|uretero ileal anastomosis in single trough|
15769201|NCT04702347|Diagnostic Test|Urine biomarker|Bladder urine samples (> 10 ml) will be collected for cytology and for the methylation test before cystoscopy. Prior to semirigid and flexible ureteroscopy, urine specimens from the upper urinary tract will be obtained via a ureteral catheter.
15769202|NCT04702334|Drug|Hyaluronic Acid|After application of local anesthetic, removal of plaque and polishing of the tooth surfaces was performed followed by the local administration of hyaluronic acid gel for the test group . The tip of blunt application needle mounted on the syringe containing HA was delicately inserted in the pocket until resistance was felt. The injection was performed until the remnants started getting out of the pocket.This adjunctive treatment was performed at baseline and at the 3 months control.
15769203|NCT04702334|Drug|Lidocain|After application of local anesthetic, removal of plaque and polishing of the tooth surfaces was performed followed by the local administration of anesthetic for the control group. The tip of blunt application needle mounted on the syringe containing HA was delicately inserted in the pocket until resistance was felt. The injection was performed until the remnants started getting out of the pocket.This adjunctive treatment was performed at baseline and at the 3 months control.
15769204|NCT04702321|Other|Procedure: Biospecimen Collection|Collection of saliva, buccal swabs, blood, or other sample adequate for germline DNA extraction
15769205|NCT04702321|Other|Procedure: Medical Chart Review|Collection of clinical data
15769206|NCT04702308|Other|Clinical Decision Rule Alerts|The
15769207|NCT04702282|Diagnostic Test|ropivacain concentration measurements|Free and total plasma concentrations of ropivacaine were measured within 24 hours using liquid chromatography - mass spectrometry. A population pharmacokinetic model was built using non-linear mixed effect models
15769208|NCT04702256|Drug|Obinutuzumab administration|"Obinutuzumab administration by intravenous infusion (IV), IV of methylprednisolone, oral mycophenolate mofetil, no prednisone (or if required for extrarenal manifestation(s): less than 10mg/day at any time, less than 7.5mg/day after 6 months and less than 5mg/day after 9 months).
~Hydroxychloroquine will be strongly recommended for all the patients."
15769209|NCT04702256|Drug|Administration of Methylprednisolone + Prednisone + Mycophenolate mofetil|"IV of methylprednisolone, oral prednisone (according to the PNDS), and oral mycophenolate mofetil.
~Hydroxychloroquine will be strongly recommended for all the patients."
15769210|NCT04702256|Drug|Administration of methylprednisolone, paracetamol and dexchlorpheniramine|Prior to infusion of obinutuzumab, patients receiving obinutuzumab will receive premedication including 100 mg of methylprednisolone, paracetamol and dexchlorpheniramine.
15769211|NCT04702243|Diagnostic Test|Genetic Testing for PCD or PID|Patients with high likelihood of a PID disorder or a high likelihood of PCD will initially undergo research genetic testing on a commercial approved panel for PID disorders or a panel of at least 37 PCD genes.
15769212|NCT04702243|Other|Unaffected Family Member Genetic Testing|Unaffected family members will undergo genetic testing if genetic findings are identified in their affected family member.
15769213|NCT04702230|Diagnostic Test|MRI|Baseline and follow-up MRI at 1 and 3 months post-TAE or post-TARE
15769214|NCT04702217|Other|Training program|A 16-week training program consisting of 2-3 visits per week, and 60 minutes per visit. The program will be done as group exercise under supervision from physiotherapists with special interest in POTS.
15769215|NCT04702204|Drug|Denosumab 60 MG/ML|"Denosumab, another antiresorptive agent, is a fully human monoclonal IgG2 antibody that binds to the receptor activator of the nuclear factor-kB ligand (RANKL) with high specificity and affinity. Denosumab inhibits bone resorption by affecting the development, activation, and survival of osteoclasts.
~Denosumab 60 mg subcutaneously was administered to the patients whose consent forms were obtained, once every 6 months."
15769216|NCT04702191|Behavioral|Triple P|Triple P - level 4 group is a group-based parenting intervention for families with children who exhibit behavioural or emotional difficulties. Group sessions typically focus on topics such as positive parenting, helping children develop, managing misbehaviour, and planning ahead. Practitioners then provide individual feedback on progress using positive parenting strategies and goal setting. Trained practitioners will deliver the program according to the manualized protocol (Turner, Markie-Dadds, & Sanders, 2010). This will include eight weekly sessions with maximum of 12 parents. The first four sessions will be as group sessions. These four group sessions will be followed by three one-to-one practical and personalised telephone consultations. Finally, there will be one group session, which will complete the programme and parents' contact with the Triple P practitioners. The main aim of this session is to review progress and plan for the future.
15769217|NCT04702191|Behavioral|Circle of Security Parenting|Circle of Security - Parenting (COS-P) will be delivered according to the protocol outlined by Cooper, Hoffman and Powell (Cooper et al., 2009). COS-P is a manualized eight-session parent-education group program which has the same broad aims and core components of the COS-Intensive model from which it was developed (i.e., to increase caregiver sensitivity and responsiveness to child cues, empathy for the child by supporting parental reflective functioning, recognition and understanding of child attachment cues, and awareness of the impact of the caregiver's own attachment history on caregiving patterns). The program is led by one or two facilitators and includes 10-12 caregivers. The program uses clinical DVD clips of problematic parent-child interaction and healthy alternatives to illustrate attachment patterns and parenting styles, and to promote group discussion.
15769218|NCT04702178|Biological|COVAC-2|Intramuscular vaccine against SARS-CoV-2
15769219|NCT04702178|Biological|Saline Placebo|Intramuscular injection of saline placebo
15769220|NCT04702165|Device|lung resection with Lung Resection Marker Locator Kit|Nodules eligible for surgical resection using the Lung Resection Marker Locator Kit
15769221|NCT04702152|Behavioral|Targeted memory reactivation (sounds)|I will unobtrusively and repeatedly present learning-related sounds during sleep using speakers. This method was shown to improve memory in various tasks. The sounds will be presented several seconds apart and the volume will be so adjusted as not to disturb the participant's sleep. The sounds will be presented during non-rapid eye movement sleep (sleep stage 2 and slow wave sleep). The sounds presented will be non-congruently related to the scenes in the previous learning task. This manipulation is within-subject - all participants will get it, but different specific sounds will be presented for each individual participant.
15769222|NCT04702139|Device|shoulder arthroplastis|- Group (Treatment): Placement of the Game-Ready splint immediately after surgery for 12 hours. They will then be put on the standard splint which they will keep for 2 weeks as for the other group but without ice packs.
15769223|NCT04702139|Device|shoulder arthroplastis|- Group (Control): Placement of a standard splint immediately after surgery for 2 weeks with ice packs to be used for an average of 8 days.
15769224|NCT04702113|Diagnostic Test|Cipherome Lighthouse Pilot|Preemptive pharmacogenomic testing
15769225|NCT04702100|Other|instrument assisted soft tissue mobilization|the patients will receive instrument-assisted soft tissue mobilization:The subject was seated in a relaxed sitting position. M2T blade was used to find specific areas of restriction on RT upper trapezius. Then treatment plane 1 - 2 and 3 were used.The lubricant (Vaseline) was applied to the skin around the neck area prior to treatment and the tool was cleaned with an alcohol preparation pad. Then by using M2T blade with angle 45, we were giving long slow strokes without causing any discomfort or pain over muscle starting from its insertion up to its origin approximately for 2 to 3 min repeated two times.
15769226|NCT04702100|Other|integrated neuromuscular inhibition technique|will receive integrated neuromuscular inhibition technique: from supine lying position.we the patients will perform ischemic compression at trigger points then positional release technique and finally muscle energy technique.
15769227|NCT04702100|Other|conventional therapy|the patients will receive hot back for 10 minutes, active range of motion exercise, chin tuck, stretches
15769228|NCT04702087|Dietary Supplement|OLEP|omega 3 (500 mg), leucine (2,5 g), probiotic Lactobacillus paracasei PS23
15769229|NCT04702087|Combination Product|Placebo|Isocaloric formula
15769230|NCT04702074|Drug|Traditional Chinese medicine granules|"Bu Fei Jian Pi Hua Tan granule for syndrome of the lung and spleen qi deficiency and unclean phlegm dampness.
~Yi Qi Yang Yin Qing Fei granule for syndrome of qi and yin deficiency and unclean phlegm heat.
~Traditional Chinese medicine granules will be administered twice daily for 2 months."
15769231|NCT04702074|Drug|Traditional Chinese medicine granules placebo|"Bu Fei Jian Pi Hua Tan granule placebo for syndrome of the lung and spleen qi deficiency and unclean phlegm dampness.
~Yi Qi Yang Yin Qing Fei granule placebo for Syndrome of qi and yin deficiency and unclean phlegm heat.
~Traditional Chinese medicine granules placebo will be administered twice daily for 2 months.
~The appearance, weight, color and odor of the preparation are the same as those of experimental group.
~The granule placebo consists of dextrin, bitter and 5% of the Traditional Chinese medicine granules ."
15769232|NCT04702061|Other|Erector spina plane block before general anaesthesia|After skin infiltration with 2 ml of 2% lidocaine, an 18 G tuohy needle will be directed between the erector spina muscle and the transverse process of the T4 vertebra using the in-plane technique. The location of the needle will be confirmed by hydrodissection with saline after touching the transverse process. After the plan open, 5 ml of 2% lidocaine, 10 ml of 0.5% bupivacaine and 10 ml of saline, including hydrodissection, will be given in a total amount of 25 ml. Then a 20-G epidural catheter will be inserted 3-4 cm and fixed.
15769233|NCT04702061|Other|Thoracic epidural block before general anaesthesia|After skin infiltration with 2 ml of 2% lidocaine, an 18 G tuohy needle will be entered through the T4-5 interspinous space (median or paramedian approach). After reaching the thoracic epidural area by loss of resistance method, the epidural catheter will be advanced and fixed to remain 3-4 cm in the epidural area. Following the test dose (2 ml of 2% lidocaine), 3 ml of 2% lidocaine, 5 ml of 0.5% bupivacaine and 5 ml of saline will be administered intermittently in a total volume of 15 ml.
15769234|NCT04702048|Drug|Aflibercept Injection|Patients randomized to Arm A will receive 2 mg IVT aflibercept injections every 4 weeks (Q4W) to Week 20, followed by 2-mg aflibercept injections Q8W to Week 52.
15769235|NCT04702048|Drug|Sham injection|Patients randomized to Arm B will receive sham intravitreal injections every 4 weeks (Q4W) to Week 20, followed by sham intravitreal injections Q8W to Week 52. Sham means eye will be numbed and a syringe with no needle will be touched to the eye.
15769236|NCT04702035|Device|Characterization of walking pattern characteristics in an ambulatory setting using wearable IMUs (ZurichMOVE sensors)|All participants receive a set of 5 wearable IMUs for a period of 3 days. The IMUs are fixed at both wrists, ankles and one over the sternum. A 10-meter walking test, 180 degree turnaround test and normal walking at home are performed. Afterwards, the IMUs are removed for data extraction and evaluation. The patient group is examined a second time after CSF diversion surgery.
15769237|NCT04702022|Diagnostic Test|18FDG PET / CT|The PET/CT procedure was performed using cross-calibrated Philips Gemini TF Big Bore or TF 16 PET/CT systems (Philips Medical Systems, Cleveland, OH) at 201 18 minutes following intravenous injection of a mean dose of 3.2 0.2 MBq/kg of body weight of 18 F-FDG. A low-dose helical CT (5-mm slice thickness, 120-kV tube voltage, and 40-mAs tube current-time product) centered to the renal transplant was performed, followed by PET scanning with two bed positions, each lasting 240 seconds. Images were reconstructed using iterative list mode time-of-flight algorithms. Corrections for attenuation, dead time and random and scatter events will be applied.
15769238|NCT04702009|Drug|Anti-PD-1/PD-L1 Monoclonal Antibody，Chemotherapy|Anti-PD-1/PD-L1 monoclonal antibody (approved anti-PD-1/PD-L1 monoclonal antibody)；albumin paclitaxel/docetaxel + carboplatin (albumin paclitaxel 130mg/m2, d1 d8, Docetaxel 75mg/m2, carboplatin AUC=5, d1, every 21 days, 4 cycles of chemotherapy; immunotherapy no more than 2 years)
15769239|NCT04702009|Device|Bronchoscopy-assisted Interventional Therapy|Bronchoscopy-assisted interventional therapy (1 time before chemotherapy or 2 times before chemotherapy and before the third cycle of treatment)
15769240|NCT04701996|Biological|serological surveillance|serological surveillance, detection of antibodies (Total Ig and IgM) developed against SARS-CoV-2 in a population living in a rural area (Kimpese, DRC)
15769241|NCT04701983|Drug|Itepekimab SAR440340|Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous
15769242|NCT04701983|Drug|Placebo|Pharmaceutical form: solution for injection in pre-filled syringe Route of administration: subcutaneous
15769243|NCT04701970|Procedure|relining of mandibular complete denture|Relining of mandibular dentures was performed by reducing one mm of the denture fitting surfaces and borders to make a right-angled border. apply two separate layers of Mucopren adhesive upon the vestibular surface of the mandibular denture and allow each layer to dry for about 40 seconds. then, the lower denture was inserted and molded in patient mouths; while biting in centric occlusion with the opposing maxillary complete dentures.
15769244|NCT04701957|Behavioral|Ketogenic diet|The Atkins 2: 1 diet as prescribed for the participants of our intervention group (N = 35) is based on a diet moderately rich in protein (meat, fish, cheese, eggs, vegetable proteins) and without restriction of fats, provided they are balanced, but limiting the carbohydrate intake (bread, pasta, rice) to 50 grams / day. The ratio calories from fat / calories from protein + carbohydrates will be 3 to 1
15769247|NCT04701892|Other|Indicators of central sensitisation|Indicators of central sensitisation, assessed by the Central Sensitization Inventory
15769248|NCT04701879|Other|Spine decompression with core stability exercises|"50 minutes per session
~Decompression with core stability on alternate days for 8 visits."
15769249|NCT04701879|Other|Spine decompression|"40 minutes per session
~-Decompression therapy on alternate days for 8 visits."
15769250|NCT04701866|Other|Music|Music will be provided via headphones during all 6 ketamine treatments, beginning at the commencement of each infusion and ending 55 minutes later. On the day of each infusion, before the treatment begins, clinicians will discuss music choices with participants in order to select amongst one of several options that have been designed for this purpose (length, genre, intensity, etc.).
15769251|NCT04701853|Other|Specific abdominal muscle training|Specific abdominal muscle training
15769252|NCT04701853|Other|Usual care|Care according to each center.
15769253|NCT04701827|Combination Product|AWARE intervention|Comprehensive 360 degrees intervention. The intervention targets multiple aspects of the described enhancers of functioning based on on the ICF Brief Core Set. 1) ADL ability as a part of carrying out daily routines 2) Mood symptoms, medication and side effects 3) Social, relatives and network 4) Physical health, including BMI, biomarkers and exercise5) Cognition, circadian rhythm measured as sleep quality, and coping (stress reduction).
15769254|NCT04701814|Other|biomechanical scapular mobilization with movement and motor learning|the therapist applied posterior tilt and exteral rotation with upward rotation mobilization to scapula and therapist also warp bilt around GH joint to applied inferior and posterior glid then ask patient to elevate his arm. then we applied motor learning approach by asking patient to elevate his arm with maintaining of external rotation with posterior glid of scapula.
15769255|NCT04701801|Diagnostic Test|Moca test|Preoperative Moca test and State-Trait Anxiety Inventory Test (STAI FORM TX - I State Anxiety Scale) questionnaire form will be filled in female patients between the ages of 18-65 by making a one-on-one interview with the patient and the MoCA test will be applied in the early postoperative period (1st week) to ensure its relationship with POKD will be checked.
15769256|NCT04701788|Biological|23-valent pneumococcal polysaccharide vaccine|The study group and the control group were injected with a dose of 23-valent pneumococcal polysaccharide vaccine. One month later, blood was collected and serum was separated.
15769257|NCT04701775|Dietary Supplement|Only Lactobacillus rhamnosus GG strains|1x106 colony forming unit (CFU) Lactobacillus rhamnosus GG probiotic capsule
15769258|NCT04701775|Combination Product|Combined Lactobacillus acidophilus and Bifidobacterium animalis subsp.lactis strains|combination of Lactobacillus acidophilus 1x109 CFU and Bifidobacterium animalis subsp.lactis 1x109 CFU probiotic capsule
15769259|NCT04701775|Other|Placebo|Placebo probiotic capsule
15769260|NCT04701762|Device|GlideScope videolaryngoscope (Verathon, Bothell, WA 98011)|After confirming adequate muscle relaxation, initial laryngoscopy will be performed using GlideScope videolaryngoscope with an appropriately sized blade (usually size 3 or 4). The GlideScope (Verathon, Bothell, WA 98011) is an FDA-cleared commercially available portable videolaryngoscope.
15769261|NCT04701762|Device|Direct laryngoscopy|After confirming adequate muscle relaxation, initial laryngoscopy will be performed using direct laryngoscopy with an appropriately sized Macintosh or Miller blade (usually size 3 or 4);
15769262|NCT04701749|Device|Percutaneous left atrial closure|Percutaneous left atrial closure was performed under general anesthesia with angiographic control and transesophageal echocardiography. The procedure takes between 15 and 20 minutes. This begins with a right femoral venipuncture, progression of the guide in the right atrium allowing atrial trans-septal puncture to catheterize the left atrium. A nitinol prosthesis is implanted (Boston Watchman) at the ostium of the left auricle between the left superior pulmonary vein and the circumflex artery. After a tensile test verifying the stability of the prosthesis, the absence of peri-prosthetic leakage is verified by ETO and angiographic control. The patient is monitored 48 hours before discharge to eliminate the appearance of pericardial effusion and prosthetic embolization. Aspirin 75 mg monotherapy is started the same day with stopping anticoagulation.
15769263|NCT04701749|Other|No Percutaneous left atrial closure|No Percutaneous left atrial closure
15769264|NCT04701736|Device|Picture Medication Calendar|
15769265|NCT04701723|Other|cardiac coherence|standard care associated to cardiac coherence training during 3 months
15769266|NCT04701710|Drug|Ivermectin / Iota-Carrageenan|The EG received Ivermectin orally 2 drops of 6 mg = 12 mg every 7 days, and Iota-Carrageenan 6 sprays per day for 4 weeks.
15769267|NCT04701697|Drug|Recombinant Human Albumin Injection|Participants will receive Recombinant Human Albumin Injection of intravenous infusion
15769268|NCT04701697|Drug|HumanAlbumin|Participants will receive HumanAlbumin of intravenous infusion
15769269|NCT04701684|Device|Direct to Angio Suite (DTAS) Philips' CBCT triage|Stroke patients are diagnosed and treated (mechanical thrombectomy) in the same angio suite
15769270|NCT04701684|Procedure|Conventional CT/MR triage|First a CT or MRI exam is acquired for triage. In case of an ischemic stroke the patient is then treated in an interventional suite.
15769271|NCT04701671|Behavioral|Observational (not including MRI scanning)|Observational data will be obtained through self-report measures, parental report measures, cognitive assessments, and a semi-structured interview.
15769272|NCT04701671|Behavioral|Observational (including MRI scanning)|Observational data will be obtained through self-report measures, parental report measures, cognitive assessments, fMRI imaging, and a semi-structured interview.
15769273|NCT04701658|Drug|Bamlanivimab|Administered intravenously.
15769303|NCT04701372|Behavioral|Exposure and response prevention therapy|Exposures and response prevention therapy (a type of cognitive-behavioral therapy for obsessive-compulsive disorder), delivered in real-time by licensed therapists remotely via video. The treatment was augmented by between-session text messaging and online community support.
15769304|NCT04701359|Device|TiN-alloy based total knee arthroplasty|TiN-alloy based TKA implanted for knee osteoarthritis.
15769305|NCT04701359|Device|CoCr-coating based total knee arthroplasty|CoCr-coating based TKA implanted for knee osteoarthritis.
15769306|NCT04701346|Other|Low SAA diet|Diet with low content of methionine and cysteine
15769274|NCT04701645|Combination Product|Microdevice|"Placement of 1 to 6 implantable microdevices with multiple miniature drug reservoirs into a tumor mass 24 +/- 8 hours prior to surgery. Drugs will be released over 24 (+/- 8) hours while the microdevice is in the tumor prior to retrieval. The local tissue is retrieved along with the microdevice and no residual drug will remain.
~Each microdevice will harbor up to 20 drugs and drug combinations relevant to the treatment of ovarian cancer.
~Each drug or drug combination will be released from a single, separate reservoir. At least two reservoirs will harbor a drug vehicle only.
~Drugs will include all or a subset of the following: Cisplatin, Carboplatin, Paclitaxel, Doxorubicin or pegylated liposomal doxorubicin (PLD), Cyclophosphamide, Etoposide, Gemcitabine, Ifosfamide, Pemetrexed, Topotecan, Vinorelbine, Olaparib, Niraparib, Rucaparib, Carboplatin + paclitaxel (combination), Carboplatin + doxorubicin (combination),Carboplatin + gemcitabine (combination)"
15769275|NCT04701619|Other|Immuno-inflammatory profile description in patients with ischemic stroke|Patients will be evaluated for inflammatory biomarkers at inclusion, at 24-48 hours of reperfusion treatment , at 72 hours, at 7 days or at discharge if before D7, at discharge if after D7, at 3 months and at 1 year.The biomarkers will be measured using ELISA panels for inflammatory biomarkers
15769276|NCT04701606|Drug|Artecom® (pyronaridine-artesunate)|"* Participant body weight (Artecom® dose)
~≥ 65kg (Artecom® 4 tablets: Pyronaridine 720mg/ Artesunate 240mg)
~≥ 45kg and < 65kg (Artecom® 3 tablets: Pyronaridine 540mg/ Artesunate 180mg)"
15769277|NCT04701606|Drug|Placebo|"* Participant body weight (Placebo dose)
~≥ 65kg (Placebo 4 tablets)
~≥ 45kg and < 65kg (Placebo 3 tablets)"
15769278|NCT04701593|Drug|Triamcinolone Acetonide 40mg/mL|Sub-tenon irrigation 1cc
15769279|NCT04701580|Diagnostic Test|11C-UCB-J PET-CT|Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 11C-UCB-J.
15769280|NCT04701580|Diagnostic Test|18F-FDG PET-MR|Positron Emission Tomography (PET) of glucose metabolism using the radioligand 18F-FDG, and brain MRI performed simultaneously.
15769281|NCT04701567|Diagnostic Test|Magnetic resonance imaging|Advanced multiparametric MRI techniques to diagnose hepatic and pancreatic disease
15769282|NCT04701554|Other|Qigong program|The intervention group received sixteen sessions lasting one hour with different techniques of diaphragmatic breathing, concentration techniques and exercises with smooth and coordinated musculoskeletal movements. The Qigong program was performed by a therapist with more than 10 years of experience.
15769283|NCT04701554|Other|Information on healthy lifestyles, physical exercise and dietary recommendations.|The control group received information on healthy lifestyles, physical exercise and dietary recommendations.
15769284|NCT04701541|Device|Diaphragmatic Ultrasound|Diaphragmatic ultrasound is non-invasive, portable, quick to perform, with a linear relationship between diaphragmatic movement and inspired volume. In eligible patients, a preoperative baseline ultrasound evaluation of the diaphragm and lungs is accomplished. Evaluation will be performed by a single operator, blinded to the arterial blood gas analysis values. In a semi recumbent position, patients will be asked to rest and breath quietly. An anterior approach will be carried out applying freehand transducer on abdomen at the right midclavicular line immediately below the costal margin with firm pressure, steering in cranial direction. A B-mode transverse scanning will be performed looking across the liver with gallbladder in the middle. Measurements will be recorded by the M-mode frozen images. The M-mode modality will be used to study DIA. The best sinusoidal curve will be considered for measurements.
15769285|NCT04701528|Drug|Voclosporin|Temporarily switching of tacrolimus maintenance immunosuppression to voclosporin maintenance immunosuppression with possible additional anti-viral activity
15769286|NCT04701528|Drug|Tacrolimus|Comparator
15769287|NCT04701515|Other|Chart review|Chart review
15769291|NCT04701489|Device|Splenic ultrasound|GE LOGIQ E10 device with C1-6 ultrasound probe
15769292|NCT04701476|Drug|TATE and pembrolizumab|All liver metastatic lesions will be treated with TATE for maximally debulking. Pembrolizumab IV infusion every 3 weeks until progression or maximally 2 years.
15769293|NCT04701463|Dietary Supplement|L-glutamine, L-arginine and calcium beta-hydroxy-beta-methylbutyrate|2 daily sachets (mid morning and mid afternoon) of an oral dietary supplement with L-glutamine and L-arginine and calcium beta-hydroxy-beta-methylbutyrate
15769294|NCT04701463|Combination Product|Placebo|Isocaloric formula
15769295|NCT04701450|Other|digital consent|the patient's medical history is taken in a digital survey, information about the anaesthetic procedure is aided by video material
15769296|NCT04701437|Behavioral|Peer mentor|Peer mentors will contact participants within 72 hours of enrollment to discuss the early release period, gauge their readiness for HCV treatment, and identify ancillary needs. They will also accompany the participant to their first medical appointment with an HCV provider and any future appointments if requested by the participant. Peer mentors will offer participants social support throughout the 6 months they are enrolled in the study.
15769297|NCT04701437|Behavioral|Standard of care|Passive referral to a HCV provider
15769298|NCT04701424|Device|CamAPS HX Closed-loop|"The CamAPS HX closed-loop system comprises:
~Dana insulin pump (Diabecare, Sooil, Seoul, South Korea) Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA) An Android smartphone hosting CamAPS HX Application with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump Glooko/Diasend cloud upload system to monitor CGM/insulin data."
15769299|NCT04701424|Other|Multiple Daily Insulin Injections (Control)|Multiple Daily Insulin Injections with masked Dexcom G6 CGM sensor (Dexcom, Northridge, CA, USA)
15769301|NCT04701398|Other|Multimodal prehabilitation|Exercise + nutritional supplementation + psychological advice
15769302|NCT04701385|Diagnostic Test|Optical Coherence Tomography (OCT)|Optical Coherence Tomography (OCT) can undertake detailed characterisation of plaque morphology in patients with myocardial infarction at the time of percutaneous treatment. This allows plaque rupture, erosion and other mechanisms of myocardial infarction to be differentiated
15836298|NCT04154540|Other|Motion analysis|Gait and posture recording
15769307|NCT04701346|Other|High SAA diet|Diet with high content of methionine and cysteine
15769308|NCT04701333|Drug|Cabergoline 1 MG|Dopamine agonist
15769309|NCT04701333|Drug|Placebo|Placebo
15769310|NCT04701320|Drug|Conventional glass ionomer|Conventional glass ionomer with enhanced mechanical and esthetic proberties
15769311|NCT04701320|Drug|Nano hydroxyapatite reinforced glass ionomer|Nanohydroxyapatite reinforced glass ionomer restorative material with enhanced mechanical proberties and chemical adhesion to tooth structure
15769312|NCT04701307|Biological|Dostarlimab|Given IV
15769313|NCT04701307|Drug|Niraparib|Given PO
15769314|NCT04701294|Device|Giomer Beautifil flow plusF03 Shofu-Japan|A pair of permanent first molars will be used for each participant homologs The operator will apply in the upper / lower first molars the sealant material in the order assigned according to the previous randomization. For the intervention group, they will be sealed based on a fluid resin with s-prg glass ionomer filling (Giomer F03 Beautiful -Shofu) in association with a bottle of adhesive (Single Bond) . The evaluation and monitoring process; another operator will record the retention of the sealant in a period of 6, 9 and 12 months.
15769315|NCT04701294|Device|Tetric N flow ivoclar vivadent-Germany|And on the contralateral side (control) the first upper / lower molars will be sealed will be sealed with a fluid resin compound (Tetric N-Flow ivoclar vivadent) in association with a bottle of adhesive (Single Bond). Both materials have a similar color. The operator and the child will not be informed about the brand of the material used. The assistant will collect the data in the file. The evaluation and monitoring process; another operator will record the retention of the sealant in a period of 6, 9 and 12 months.
15769317|NCT04701268|Other|Device: Hemiverse|Implantation of the hemiverse shoulder prothesis
15769318|NCT04701255|Procedure|phacoemulsification with intraocular lens implantation|treatment of cataract by phacoemulsification procedure and implantation of different types of IOLs.
15769319|NCT04701255|Device|ocular aberrometer assesment|evaluate total ocular wavefront, corneal wavefront & internal wavefront (High order aberrations ) post operative by corneal tomography and aberrometer
15769320|NCT04701242|Drug|Ezetimibe 10mg|comparing upfront use of Ezetimibe (added to high intensity statins) after acute myocardial infarction versus selective Ezetimibe initiation to those failing to achieve LDL-C targets when assessed in follow up visit.
15769321|NCT04701229|Genetic|somatic cytogenetic and genetic characterization|investigating the presence of some genes allelles (RBM22, SLU7, RBM27, other on chromosome 5) by FISH, and sequencing of a classical panel of myeloid genes including RBM22, SLU7, for somatic identification of genetic alterationss of the blasts.
15769322|NCT04701216|Drug|SHR8735|SHR8735 is an thrombopoietin receptor agonist to promote platelet production.
15769323|NCT04701203|Combination Product|TransCon PTH|TransCon PTH drug product is supplied as a solution with a concentration of 0.3 mg PTH(1-34)/mL in a single-patient-use prefilled pen intended for subcutaneous injection.
15769324|NCT04701203|Combination Product|Placebo|Placebo is supplied as a solution containing the formulation buffer for TransCon PTH in a single-patient-use prefilled pen intended for subcutaneous injection.
15769325|NCT04701190|Drug|Noradrenalin 10 microgram bolus|The noradrenaline bolus dosage of 10 microgram will be administered to the patient at the same time of obtaining cerebrospinal fluid running freely.
15769326|NCT04701190|Drug|Noradrenaline 5 microgram bolus|The noradrenaline bolus dosage of 5 microgram will be administered to the patient at the same time of obtaining cerebrospinal fluid running freely.
15769327|NCT04701190|Drug|Noradrenaline 0.1 microgram/kg/minute infusion|"Infusion dosage: 0.1 microgram/kg/minute After the end of the injection of heavy marcaine 0.5% to the subarachnoid space, the infusion of noradrenaline with a 0.1 microgram/kg/minute dosage will be started.
~Noradrenaline will be continued until 5 minutes after delivery of fetus."
15769328|NCT04701190|Drug|Noradrenaline 0.05 microgram/kg/minute infusion|"Infusion dosage: 0.05 microgram/kg/minute After the end of the injection of heavy marcaine 0.5% to the subarachnoid space, the infusion of noradrenaline with a 0.05 microgram/kg/minute dosage will be started.
~Noradrenaline will be continued until 5 minutes after delivery of fetus."
15769329|NCT04701190|Drug|Infusion dosage: 0.075 microgram/kg/minute infusion|"nfusion dosage: 0.075 microgram/kg/minute After the end of the injection of heavy marcaine 0.5% to the subarachnoid space, the infusion of noradrenaline with a 0.075 microgram/kg/minute dosage will be started.
~Noradrenaline will be continued until 5 minutes after delivery of fetus."
15769330|NCT04701190|Procedure|Spinal anesthesia|Spinal anesthesia using 0.5% 10 milligram heavy bupivacaine plus 12.5 microgram fentanyl
15769331|NCT04701177|Diagnostic Test|AltoidaML|Computerized Complex Instrumental Activities of Daily Living Marker (NMI) (AltoidaML). ClinicalTrials.gov Identifier: NCT02843529
15769332|NCT04701164|Drug|ANX005|Solution for intravenous infusion
15769333|NCT04701164|Drug|Placebo|Solution for intravenous infusion
15769334|NCT04701151|Drug|Bacillus Calmette Guerin|The same dose of the drug will be given in both arms but the dwell-time will be adjusted for the subjects in the intervention arm according to the grading of side effects given by the study algorithm.
15769335|NCT04701138|Dietary Supplement|SPM Active|Each capsule contains 145 mg of SPMs (fractionated marine lipids standardized to 18-HEPE, 14-HDHA, and 17-HDHA). All subjects will take 4 capsules orally each day for a total daily dose of 580 mg.
15769336|NCT04701125|Device|selective head-neck cooling using PolarCap system|Players receiving selective head-neck cooling after SRC
15769337|NCT04701112|Device|Temporary His bundle pacing|"Temporary use of a Medtronic 3830 electrode placed in the region of His bundle, in combination with a Medtronic 5392 dual chamber external pacemaker and a temporary Edwards D200F7 Swan Ganz Pacing -catheter with atrial pacing capability.
~AV synchronous pacing (DDD 60/minute during rest and 120/minute during exercise, AV delay 150/180ms) will be performed using the atrial port (pacing catheter atrial electrodes) and ventricular port (His bundle electrode), or in the case of atrial fibrillation, only pacing the the His bundle in VVI mode 60/minute during rest and 120/minute during exercise.
~The Swan-Ganz will then be used for hemodynamic measurements during pacing. A Cardiotek ECG system will be used for simultaneous 12 lead ECG registration."
15769338|NCT04701086|Device|Cationorm Pro|Eye Drops
15769339|NCT04701086|Device|Vismed|Eye Drops
15769431|NCT04700241|Dietary Supplement|Potassium nitrate|Acute intervention (5.5 hours)
15769340|NCT04701073|Device|LombaStab belt|"Instruction given to the patient will be to wear the LombaStab belt from 4 to 8 hours per days, over the whole duration of the study (12 weeks). The investigator will explain to the patient how to adjust it.
~The LombaStab belt will be equiped with thermosensor to evaluate the belt wearing time at the end of the study."
15769341|NCT04701060|Drug|Camrelizumab:200mg， iv，d1 q2w;apatinib:250mg,po，qd，q2w|preoperative：Camrelizumab ：200mg， iv，d1 q2w；apatinib：250mg,po，qd，q2w；four cycles， operation postoperation 4-8weeks，Camrelizumab ：200mg， iv，d1 q2w；apatinib：250mg,po，qd，q2w；Up to one year
15769342|NCT04701047|Device|vaginal pessary|insertion and follow up of a vaginal pessary
15769343|NCT04701047|Procedure|Vaginal prolapse surgery|surgery and follow up after vaginal prolapse surgery
15769344|NCT04701034|Drug|Human Intravenous Immunoglobulins, (Privigen (R), CLS Behring)|"Privigen 100 mg/ml (CLS Behring); Infusion of approximately 0.4 ml/kg body weight. Administration is planned at the time of embryo/blastocyst transfer (5 days before to 2 days after ET) and if she becomes pregnant, the infusion is repeated in the same dose in gestational week 5, 6, and 7.
~Patients with pre-pregnancy weight ≤70 kg will receive 25 g Privigen (250 ml), patients with weight 70-85 kg will receive 30 g Privigen (300 ml), and patients with weight ≥85 kg will receive 35 g Privigen (350 ml) at each infusion, which will approximate 0.4 g IVIg per kg body weight."
15769345|NCT04701034|Drug|Prednisolone Tablets|Prednisolone DAK, tablets, 5mg. 1 tablet daily from first day of menstrual cycle and until embryo/blastocyst transfer. On the day of embryo/blastocyst transfer, she will double her dose to 2 tablets daily until negative pregnancy test, pregnancy week 8+0 or the time of biochemical loss/miscarriage, whichever comes first.
15769346|NCT04701034|Drug|Human Albumin Solution|Human albumin, 5%, (CLS Behring). 0.4 ml/kg body weight. Administration is planned at the time of embryo/blastocyst transfer (5 days before to 2 days after ET) and if she becomes pregnant, the infusion is repeated in the same dose in gestational week 5, 6, and 7.
15769347|NCT04701034|Drug|Placebo|The Placebo tablets contain 85 mg of lactose monohydrate, 85 mg potato starch, 8.1 mg, talc 3 mg gelatine, and 0.9 mg magnesium stearate. 1 tablet daily from first day of menstrual cycle and until embryo/blastocyst transfer. On the day of embryo/blastocyst transfer, she will double her dose to 2 tablets daily until negative pregnancy test, pregnancy week 8+0 or the time of biochemical loss/miscarriage, whichever comes first.
15769348|NCT04701021|Biological|TENDU|The vaccine is administrated by subcutaneous injections, one injection per drug substance (four separate injections) consecutively.
15769349|NCT04701008|Drug|Ketamine|IV ketamine - 10mg bolus may be repeated repeated 2-3 times depending on clinical judgement
15769350|NCT04700995|Procedure|NiTi instruments|Root canal filling removal
15769351|NCT04700982|Other|Based on the length of hospital stay|Based on the length of hospital stay, patients were divided into two groups: hospital stays ≤ 3 months (Group 1) and > 3 months (Group 2).Clinical features and functional output will be then compared between the groups.
15769352|NCT04700969|Other|: A support program to facilitate implementation of evidence-based practice for postoperative urinary retention|A 12-month implementation support program for multi-professional internal facilitator teams
15769353|NCT04700956|Procedure|primary abdominal closure|The linea alba will be closed to a ratio of 5mm / 5mm. Only the fascia will be sutured ; fat or muscle tissue will be avoided. Subcutaneous tissue will be closed with polyglactin 3/0 suture. The skin will be closed with a stapler.
15769354|NCT04700956|Device|abdominal closure with prophylactic mesh|After the fascia was closed with the same method, 5 cm of subcutaneous tissue will be dissected around the incision. The mesh will be placed in the supra-aponeurotic area (onlay) to a distance of laterally and cranial-caudally 5 cm from the fascia margins. The mesh used will be partially absorbable, light and large porous. After this procedure, the borders of the mesh will be fixed circumferentially on the abdominal wall using polypropylene suture to prevent the intestines from herniating on the mesh. Two subcutaneous drainage catheters will be placed in all patients with mesh.
15769355|NCT04700943|Procedure|Regional awake anesthesia|We want to assess the impact of regional anesthesia on diaphragmatic function in patients undergoing Video-assisted thoracoscopic surgery pulmonary biopsy in interstitial lung disease
15769356|NCT04700930|Other|CBD-Cigarettes|CBD-Cigarettes instead of normal Cigarettes: The participants in this arm receive CBD-Cigarettes which are then inhaled/smoked instead of their normal tobacco cigarettes
15769357|NCT04700917|Behavioral|Cognitive Behavioural Therapy|Internet-Based CBT
15769358|NCT04700891|Diagnostic Test|Olfactory identification test|"Burghart Sniffin' Sticks Screening 12 Test Olfactory function will be evaluated through the Sniffin' Sticks test which is a validated psychophysical testing method. Sniffin' Sticks test is based on pen-like odor dispensing devices that will be presented to the patients. The short version of this test will be used and will consist solely of a test of odor identification function."
15769359|NCT04700891|Diagnostic Test|Edmonton Frail Scale|The Edmonton Frail Scale (EFS) involves nine domains of frailty : functional performance, cognitive function, general health, functional independence, social support, used medications, nutrition, mood and continence. It has been validated with respect to comprehensive geriatric assessment and to other screening tools related to frail state. EFS test is considered most appropriate for use in routine preoperative screening and only requires 5 minutes.
15769360|NCT04700891|Diagnostic Test|Handgrip strength|Handgrip strength is a simple and reliable measurement technique for the assessment of maximal voluntary hand force. Handgrip strength is used as a reflect of nutritional status and muscle mass, physical function and health status. Measurement will be realized using a digital handgrip dynamometer. Patients will be asked to grip the dynamometer with the second finger node at 90° angle to the handle and to grab the handle as strongly as they can. Maximal grip strength will be checked with the forearm away from the body in standing position.
15769363|NCT04700865|Diagnostic Test|AF screening|Continous ECG monitoring for minimum 3 days
15836325|NCT04154306|Dietary Supplement|Red clover|2 weeks of Red clover
15769364|NCT04700852|Device|Puressentiel protective nasal spray|provocative nasal test with grass pollen and nasal lavage
15769365|NCT04700839|Drug|SGLT2 inhibitors|This isa novel drug for the treatment of type 2 diabetes, with weight loss, reducing insulin resistance and cardiovascular benefits.
15769366|NCT04700839|Drug|Metformin|metformin
15769367|NCT04700826|Drug|Direct Oral Anticoagulants|choice of DOAC (apixaban, dabigatran, edoxaban or rivaroxaban) according to local practice
15769368|NCT04700813|Diagnostic Test|search for rare pathogenic mutations|search for rare pathogenic mutations causing diabetes type 2
15769369|NCT04700800|Other|Exercise|Acute cycle-ergometer exercise for 45 minutes at 65% of peak oxygen uptake
15769370|NCT04700800|Other|Infusion of Amino Acids|Intravenous infusion of mixture of amino acids
15769371|NCT04700787|Drug|Sulopenem|sulopenem intravenous 1000 mg on Day 1 and then sulopenem etzadroxil/probenecid oral 500 mg/500 mg on Day 2
15769372|NCT04700774|Behavioral|Behavioral activation|Brief Behavioral Activation Treatment with and without motor enhancement. All patients will receive 10 online video sessions. BA focuses on increasing overt behaviors to bring patients into contact with reinforcing environmental contingencies and corresponding improvements in thoughts, mood, and quality of life (Hopko, Lejuez, et al., 2003). BA follows the basic behavioral principles of extinction, shaping, fading, and in vivo exposure (Hopko & Lejuez, 2007; Lejuez et al., 2001, 2011). In the mBA condition only a) patients will be introduced to the idea that the motor system can be used in the service of action initiation and will receive an audio recording with motor manipulations to assist in action initiation and b) the therapist will conduct imaginary behavioral activation and - in session - complete questionnaires identical to those in the experiment before and after the bodily instructions presented in the treatment.
15769373|NCT04700761|Procedure|Opioid-free anesthesia|Anesthesia induction: thiopental, rocuronium, desflurane + single dose of alfentanil for endotracheal intubation Anesthesia maintenance: desflurane (without any opioid) Rescue for hypertension, tachycardia: desflurane and beta blocker/calcium channel blocker
15769374|NCT04700761|Procedure|Opioid-using anesthesia|Anesthesia induction: thiopental, rocuronium, desflurane + continuous infusion of remifentanil (TCI, Minto model) Anesthesia maintenance: desflurane, remifentanil Rescue for hypertension, tachycardia: desflurane, remifantanil and beta blocker/calcium channel blocker
15769375|NCT04700748|Radiation|Brain metastases radiation|Brain metastases radiation according to clinical practice.
15769376|NCT04700735|Device|geko Neuromuscular Electro Stimulator (NMES)|Neuromuscular Electro Stimulator (NMES)
15769377|NCT04700722|Diagnostic Test|Skin Biopsy|Test accuracy and precision of skin biopsy detection of phosphorylated α-synuclein, define sensitivity and specificity of skin biopsy detection of phosphorylated α-synuclein deposition for the diagnosis of synucleinopathies and to differentiate between the synucleinopathies by quantitative measurement of phosphorylated α-synuclein with skin biopsies.
15769378|NCT04700709|Drug|Sirolimus Tab.|Orally, once-daily in the morning - The first dose is administered within maximum 6mg/day according to the investigator's judgement, check the blood concentration of Sirolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3~8ng/ml.
15769379|NCT04700709|Drug|Mycophenolate Mofetil Cap./Tab.|Up to 1g BID(total 2g daily), PO
15769380|NCT04700696|Behavioral|Peer Recovery Support|Weekly visits with peer who has lived experience related to child welfare and addiction
15769381|NCT04700696|Behavioral|Family Treatment Drug Court with Medications for Opioid Use Disorders (MOUD)|Incentivized to participate in Family Treatment Drug Court with option for Medications for Opioid Use Disorders (MOUD)
15769382|NCT04700696|Behavioral|Relational Skill Building based on the Nurturing Parenting Program (NPP)|Home-based parenting support
15769383|NCT04700683|Device|Noctrix Health NPNS device v1.0 - Active|Wearable device programmed to deliver electrical stimulation to peripheral nerves of the lower limbs.
15769384|NCT04700683|Device|Noctrix Health NPNS device v1.0 - Sham|Wearable device programmed to deliver sham stimulation.
15769385|NCT04700670|Biological|measurement of anti-Xa activities|"The measurement of anti-Xa activities will be carried out on frozen-defrosted plasma citrate and CTAD with 4 reagents
~STA-Liquid anti-Xa (STAGO) (not containing dextran)
~Biophen Heparin LRT (Hyphen) (reactive containing dextran)
~Berichrom (Siemens) with dextran
~Berichrom (Siemens) without dextran
~The dosage of platelet factor 4 and of the beta-TG will be carried out on frozen-defrosted plasma with the asserachrom PF4 and Asserachrom beta-TG (Diagnostica Stago) kits."
15769386|NCT04700631|Diagnostic Test|urinary extracellular vesicle concentration|urinary extracellular vesicle concentration will be determined in urine samples from CRF and healthy patients
15769387|NCT04700631|Diagnostic Test|blood sample|blood sample in order to determine creatin level
15769388|NCT04700618|Biological|23-valent pneumococcal polysaccharide vaccine|The study group and the control group were vaccinated with one dose of vaccine and blood was collected after 28-40 days.
15769389|NCT04700605|Behavioral|Dual task balance test|Participants will be conducting two dual task tests; an 8m gait test and a Wii Balance Board test with simultaneous various cognitive tests.
15769390|NCT04700592|Other|Gabapentin versus Ketamine|A Comparison of Gabapentin and Ketamine in Acute and Chronic Pain
15769391|NCT04700566|Biological|Renuva Allograft Adipose Matrix|Injection of Renuva Allograft adipose Matrix in the vocal fold for vocal fold medialization and treatment of glottal insufficiency
15769392|NCT04700553|Device|Localized muscle vibration|All patients in both experimental and control groups received CPT protocol consisted of 30 minutes of manual resistance exercise (3 sets/10 repetitions each for knee extensors and flexors) and 30 minutes of treadmill training, short breaks (1-5 minutes) were allowed, depending on the patient tolerance. The training was conducted for 3 days per week for 8 weeks. The patients in CPT+LMV experimental group received localized muscle vibration at the end of each CPT session. The LMV was applied for 5 minutes perpendicularly along quadriceps muscle fibers. The frequency set at 30 Hz, amplitude of 2 mm.
15769393|NCT04700553|Other|Conventional physiotherapy intervention|All patients in both experimental and control groups received CPT protocol consisted of 30 minutes of manual resistance exercise (3 sets/10 repetitions each for knee extensors and flexors) and 30 minutes of treadmill training, short breaks (1-5 minutes) were allowed, depending on the patient tolerance. The training was conducted for 3 days per week for 8 weeks. The patients in CPT+LMV experimental group received localized muscle vibration at the end of each CPT session. The LMV was applied for 5 minutes perpendicularly along quadriceps muscle fibers. The frequency set at 30 Hz, amplitude of 2 mm.
15769394|NCT04700540|Device|Smartwatch Reminder (SR) system|The Smartwatch Reminder (SR) system will automatically transmit pictures and relevant information, such as name or relationship, to a smartwatch worn by the PWMC when family or friends visit.
15769397|NCT04700514|Drug|Dexmedetomidine|Dexmedetomidine (1 mcg/kg loading for 10 min, then 1 mcg/kg/min continuous infusion) is used with sevoflurane in every time of general anesthesia
15769398|NCT04700501|Other|Enjoy Your Bump - CBT life skills learning programme|Antenatal use of an online Cognitive Behavioural Therapy life skills learning programme to improve maternal feelings of anxiety and low mood.
15769399|NCT04700488|Diagnostic Test|6D-MRI|Six-Dimensional Quantitative Dynamic Contrast Enhanced MRI
15769400|NCT04700475|Device|low level laser|"Laser will be performed with a GaAlAs diode laser at a wavelength of 808 nm, 100-mW output power, laser beam area of 0.03 cm2, and in continuous wave mode, three times a week, on alternate days. Laser therapy will be initiated before the first radiotherapy session and ended after the last session, totaling 21 sessions.
~The total energy per session (56 J) will be divided into 14 irradiation points, as marked on the overlying skin (Fig.2). Each irradiation point received a dose of 4 J over an irradiation time of 40 s.
~With exclusion of tumor area or area of removed tumor laser will be applied as following:
~• Extra oral application: The laser will be used extraorally at eight points in the parotid glands (bilaterally, four points in each gland), at four points in the submandibular glands (bilaterally, two points in each gland
~• Intraoral application: The will be used intraorally at two points in the sublingual glands bilaterally, one point in each gland ."
15769401|NCT04700475|Drug|citric acid solution|citric acid solution applied as a mouth rinse
15769402|NCT04700462|Behavioral|Sm-EMA|Self-monitoring ecological momentary assessment behavior change tool to promote adherence to a desired behavior (i.e. COVID-19 preventative behaviors).
15769403|NCT04700449|Drug|CBP-307|CBP-307 capsules oral administration
15769404|NCT04700449|Drug|Placebo|Placebo capsules oral administration
15769405|NCT04700436|Drug|Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg)|"IP
~Test drug: Rosuzet tablet 10/5 mg (Ezetimibe 10 mg/Rosuvastatin 5 mg)
~Control drug: Suvast tablet 10 mg (Rosuvastatin 10 mg)"
15769406|NCT04700423|Drug|moxidectin (8 mg) / albendazole (400 mg)|Combination therapy of moxidectin (8 mg using 2 mg tablets) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
15769407|NCT04700423|Drug|ivermectin (200 µg/kg) / albendazole (400 mg)|Combination therapy of ivermectin ((200 µg/kg), 3 mg tablet) plus albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
15769408|NCT04700423|Drug|ALBENDAZOLE 400 Mg ORAL TABLET [ZENTEL]|Monotherapy of albendazole (Zentel®, 400 mg, single tablet) administered orally at day 0
15769409|NCT04700423|Drug|ivermectin (200 µg/kg)|Monotherapy of ivermectin ((200 µg/kg), 3 mg tablet) administered orally at day 0
15769410|NCT04700423|Drug|moxidectin (8 mg)|Monotherapy of moxidectin (8 mg, using 2 mg tablets) administered orally at day 0
15769411|NCT04700410|Device|Pure-Vu System|All patients willing to participate will receive a limited bowel preparation (2-days of dietary restrictions + 2x 150ml picoprep) followed by intra-procedural bowel cleansing with the Pure-Vu System.
15769412|NCT04700397|Diagnostic Test|Nitroglycerine|We aim to test the repeatability of NTG-Pd/Pa with different dosages of nitroglycerine injection.
15769413|NCT04700384|Behavioral|Virtual Operative Assistant Training|Individuals receive the same basic information, have the same amount of time and perform the same scenarios as the control group. In the 5-minutes between attempts, participant receive the Virtual Operative Assistant assessment of their performance and audiovisual feedback.
15769414|NCT04700384|Behavioral|Remote-Based Expert Instructor Training|Individuals receive the same information, have the same amount of time and perform the same scenarios as the control group. Meanwhile, a trained instructor observes the participant's on-screen performance, that is live-streamed, remotely. Instructors are senior neurosurgery residents with extensive experience in performing and assessing this scenario. During the 5-minute feedback session, they chat with the student, discussing the performance and help in setting goals for the next trial.
15769415|NCT04700371|Device|Interwoven stent|Interwoven nitinol stent placement in patients with arteriosclerotic lesions of the distal portion of the superficial artery and/or the popliteal artery.
15769416|NCT04700371|Device|Laser-cut stent|Laser-cut nitinol stent placement in patients with arteriosclerotic lesions of the distal portion of the superficial artery and/or the popliteal artery.
15769417|NCT04700358|Other|Blood sampling|"Screening: Blood sampling of 15 ml whole blood
~B cell isolation: Blood sampling of max. 400 ml whole blood or 6% of the total blood volume (♀ 65 ∓ 10 ml/kg; ♂ 77 ∓ 10 ml/kg)"
15769418|NCT04700345|Device|Onyx|Embolization of the Middle Meningeal Artery using the liquid embolic material
15769419|NCT04700345|Procedure|Burr-hole|Burr-hole drainage of subdural hematoma
15769420|NCT04700345|Other|Medical Management|best medical management
15769421|NCT04700332|Drug|DCFPyL PET/CT|Prostate Membrane Specific Antigen-specific imaging
15769422|NCT04700319|Drug|CD19/CD20 CAR-T cell infusion|CD19/CD20 CAR-T,Infusion,iv,0.2×10^6-5×10^6γδT /kg,once
15769423|NCT04700306|Behavioral|Sophrology|Patient must make 8 visits with interviews and questionnaires, including 7 visits with a session of sophrology.
15769424|NCT04700293|Dietary Supplement|AYMES AMSTERDAM|AYMES AMSTERDAM is a Food for Special Medical Purposes (FSMP) and must, therefore, be used under medical supervision. It is not designed as a sole source of nutrition.
15769425|NCT04700280|Drug|GLPG3970|GLPG3970 film-coated tablet.
15769426|NCT04700280|Drug|Placebo|Placebo film-coated tablet.
15769429|NCT04700254|Other|DASS questionnaire|The DASS is a 42-item self report instrument designed to measure the three related negative emotional states of depression, anxiety and tension/stress
15769430|NCT04700254|Other|EAT-26 questionnaire|The Eating Attitudes Test (EAT-26), is a self-report 26-item questionnaire of symptoms and concerns characteristic of eating disorders.
15836326|NCT04154306|Dietary Supplement|Placebo|2 weeks of Placebo
15769432|NCT04700241|Dietary Supplement|Placebo|Acute intervention (5.5 hours)
15769433|NCT04700228|Drug|Bupivacaine Hydrochloride|We are going to see the effects of dexmedetomidine as an adjunct to bupivacaine in caudal block. In first (control) group (group C) only bupivacaine will be given. Group BD1 patients will be given bupivacaine plus 1mcg/kg dexmedetomidine. Group BD2 patients will get bupivacaine plus 0.5mcg/kg dexmedetomidine. All the groups will be given a volume of 0.5ml/kg.
15769434|NCT04700228|Drug|Dexmedetomidine|We are going to see the effects of dexmedetomidine as an adjunct to bupivacaine in caudal block. In first (control) group (group C) only bupivacaine will be given. Group BD1 patients will be given bupivacaine plus 1mcg/kg dexmedetomidine. Group BD2 patients will get bupivacaine plus 0.5mcg/kg dexmedetomidine. All the groups will be given a volume of 0.5ml/kg.
15769435|NCT04700215|Device|BiPAP|To give bilevel positive airway pressure to the lungs
15769436|NCT04700215|Device|Incentive spirometry|IS for 15 minutes after every 4 hours
15769437|NCT04700202|Other|Observational|Single center, retrospective chart review. Patients admitted to MDMC ICU from 4/1/2017 to 6/30/2020 will be identified through the electronic medical record utilizing ICD codes for HAP and VAP
15769438|NCT04700176|Drug|Daratumumab|During 28-day treatment cycles, patients will receive Dara 16 mg/kg intravenously (IV) at their current dose upon enrollment onto the study depending on their cycle. They will receive Dara depending on the cycle they are in. If they are on cycles 1-2 then they will receive Dara 16 mg/kg IV on days 1,8,15,22; if they are on cycles 3-6 they will receive Dara 16 mg/kg on days 1 and 15; and if they are on cycle 7 or beyond they will receive Dara 16 mg/kg on day 1.
15769439|NCT04700176|Drug|Pomalidomide|Pomalidomide will be administered at the patient's currently tolerated dose (4,3, or 2 mg po daily) on days 1-21
15769440|NCT04700176|Drug|All-trans retinoic acid|ATRA will be administered in a divided dose of twice daily as an oral formulation at 45mg/m2/day for 3 days. The first administration of ATRA will be given in the morning, two days before the scheduled Dara infusion. The last administration of ATRA will be given in the evening of the day that Dara was administered
15769441|NCT04700176|Drug|Dexamethasone|Dexamethasone will be administered at 40 mg once weekly on days 1,8,15 for patients 75 years old and younger and at 20 mg once weekly on days 1,8,15 for patients older than 75.
15769442|NCT04700163|Biological|C144-LS and C-135-LS|A combination of two highly neutralizing anti-SARS-CoV-2 mAbs targeting two distinct epitopes on the receptor protein binding domain (RBD) of the SARS-CoV-2 spike protein
15769443|NCT04700150|Other|Tai Chi 2 month|Tai chi sessions will consist of repetition of simple and basic movements focusing mainly on breathing, relaxation and body diagram. This Chinese martial art also includes coordination exercises of body parts (legs, arms, pelvis and spine), looseness and limbering up of joints and muscles.
15769444|NCT04700150|Other|Tai Chi 4 month|Tai chi sessions will consist of repetition of simple and basic movements focusing mainly on breathing, relaxation and body diagram. This Chinese martial art also includes coordination exercises of body parts (legs, arms, pelvis and spine), looseness and limbering up of joints and muscles.
15769445|NCT04700137|Other|Caring Contacts Plus Introductory Phone Call (CC+)|One introductory semi-structured caring phone conversation with a follow-up specialist to check-in, establish a personal connection, and provide resources at the 0-2 week time-point followed by 11 non-demanding, caring text or email messages sent over the course of 6 months.
15769446|NCT04700137|Other|Caring Contacts without an introductory phone call (CC)|Eleven non-demanding, caring text or email messages sent over the course of 6 months. Participants will not know or have spoken to the follow-up specialist who sends the caring messages.
15769452|NCT04700111|Device|DOT Pattern 1|DOT Pattern 1 Spectacle Lens
15769453|NCT04700111|Device|DOT Pattern 2|DOT Pattern 2 Spectacle Lens
15769454|NCT04700111|Device|Control lens|Control lens
15769457|NCT04700085|Device|ReMotion Knee|The ReMotion Knee is a prosthetic knee mostly used in low-income countries. It has been approved according to the ISO 10328 standards and has received the CE Mark.
15769461|NCT04700059|Behavioral|Virtual perinatal home visiting|10 perinatal home visits
15769462|NCT04700046|Drug|Mexiletine 167 mg|Mexiletine 167 mg (equivalent to mexiletine HCl 200 mg) immediate release, oral capsules.
15769463|NCT04700046|Drug|Placebo|The placebo capsules contain the same ingredients as the active formulation with the exception of mexiletine
15769464|NCT04700033|Device|Somatic IVR (sIVR)|This intervention will consist of an IVR protocol that is focused on somatic interaction that encourages disassociation between pain and visualization and movement of the affected limbs. Subjects in this group will be exposed to an IVR environment that cycles them through a series of stretching and mobility exercises for the affected limbs bilaterally.
15769465|NCT04700033|Device|Distractive IVR (dIVR)|This intervention will consist of an IVR that is focused on distracting the subject from the pain. Subjects in this group will be exposed to a variety of engaging landscape IVR environments, without the ability to visualize their own body.
15769466|NCT04700033|Device|Control IVR (cIVR)|This intervention will consist of an IVR exposure to a black screen for 20 minutes. No light, images or scenery will be present in the IVR and it will serve as a control condition for the trial.
15769467|NCT04700020|Diagnostic Test|ITT|In the context of this study, we will take two blood samples. In addition to the second blood sample, an insulin tolerance test (ITT) is also performed, even if the result of the blood values is normal. MRI will only be performed if the previous imaging was done more than two years ago or when the quality of the MRI was not good enough to measure the volume of the pituitary gland. This is needed for better analysis of the pituitary gland, as the pituitary volume could be important for the hormonal abnormalities.
15769468|NCT04700007|Drug|Capsaicin|A capsaicin patch will be applied on a 3x3 cm squared area on the volar forearm. The patch will be left in place for 24h after which it will be removed.
15769469|NCT04700007|Drug|Diphenhydramine|Diphenhydramin cream 1% (Restamine®) will be applied on a 3x3 cm squared predetermined area on the volar forearm for 24 hours.
15769470|NCT04700007|Drug|Morphine Chloride|Morphine solution (0.1mg/ml, Morphine Hydrochloride) 50 μl will be applied intradermally to the center of a predetermined area on the volar forearm by a 1 ml syringe.
15769471|NCT04700007|Drug|Isotonic saline|injections of isotonic saline (0.05 ml, 0.9%) as vehicle will be performed.
15769472|NCT04700007|Drug|Histamine|A small drop of histamine dihydrochloride (1%, in saline) will be applied to a previously determined area on the volar forearm followed by a prick through the drop.
15769473|NCT04699994|Drug|FLOT therapy|Preoperative FLOT therapy
15769474|NCT04699981|Other|Control (Patients colonized rectally with ESBL-producing enterobacteria without antibiotic pressure)|"For patients included in the Control group on discharge from hospitalization and 60 days after inclusion of patients, data will be collected either from the patient's medical file (T1Control) or during '' a telephone call from the patient (T2Control). The data collected concerns the occurrence of an infectious episode. They will also benefit from a stool sample at T1 control in order to assess the evolution kinetics of the relative fecal abundance of ESBL-producing enterobacteria in these patients who are not subjected to antibiotic pressure but subjected to other drug pressures (PPI, corticosteroids, etc.)."
15769475|NCT04699981|Other|Case (Patients colonized rectally with ESBL-producing enterobacteriaceae, with antibiotic pressure)|"A stool culture is performed on the first stool emitted after the start of antibiotic therapy. 72 hours after the start of antibiotic therapy, a blood sample (5 ml) and a stool sample will be taken. A stool sample will be taken at the end of the antibiotic therapy and 60 days after the end of the antibiotic therapy. In the event of normal transit (daily bowel movements), the stool emitted 48 hours after the start of antibiotic therapy will be analyzed. If the patient does not pass stool, an eswab rectal swab will be taken. In the event of discharge from the hospital before the end of the antibiotic therapy and / or the D60 after the end of the antibiotic therapy, the patient will be given a prescription and an appointment at the collection center of the center concerned for the sample stool."
15769476|NCT04699968|Drug|SHR-1701，Famitinib|SHR -1701, Intravenous ；Famitinib, oral
15769477|NCT04699968|Drug|SHR-1701|SHR -1701, Intravenous
15769478|NCT04699955|Behavioral|Deviance Regulation Theory|In the negative message condition, participants received information on the negative aspects of individuals that did not used protective strategies and were encouraged to report why these individuals were viewed so much more negatively. In the positive message condition, participants received information on the positive aspects of individuals that used protective strategies and were encouraged to report why these individuals were viewed so much more positively.
15769479|NCT04699942|Device|Conventional (low flow) oxygen delivery via nasal cannula|Conventional (low flow) oxygen delivery via nasal cannula or face mask for 20 minutes
15769480|NCT04699942|Device|Revoxa Oxygen Rebrearther|Oxygen delivery via Revoxa Oxygen Rebreather device for 20 minutes
15769481|NCT04699929|Drug|YH001|YH001 will be administered intravenously over 60minutes every three weeks (Q3W) for up to 1 years .
15769482|NCT04699916|Other|EEG based protocol for deep sedation|Protocol established to guide sedation drug dosification to maintain the patient with a Suppression Rate (SR) less than 1% and a Spectral Edge Frequency 95 over 10 Hz
15769483|NCT04699903|Diagnostic Test|POC SARS-Cov-2 IgG Antibody test|All patients will undergo a Point of care (POC) SARS-Cov-2 IgG Antibody test in fingerstick whole blood
15769484|NCT04699890|Other|Blood sampling, questionnaires and specific exams|Patients will have additionnal blood samples, answer to self-questionnaires and will performed an electrocardiogram and an echocardiography if not performed in routine care.
15769486|NCT04699864|Diagnostic Test|Screening of DR and DME with artificial intelligence using NeoRetina|Macula-centered eye color fundus photos will be acquired by DIAGNOS team using a non-mydriatic digital camera (without pupil dilation). After a numerical treatment, retinal images will be analyzed by NeoRetina artificial intelligence (AI) algorithm in order to find eye lesions characteristics of diabetic retinopathy (DR) and diabetic macular edema (DME). The severity of DR and DME will be graded by NeoRetina according to the ''Early Treatment Diabetic Retinopathy Study'' (ETDRS) international classification standards.
15769487|NCT04699864|Diagnostic Test|Routine ophthalmological evaluation of DR and DME|Standard of care eye examination (blind assessment) will be performed by an ophthalmologist of the CHUM in order to find lesions characteristics of diabetic retinopathy (DR) and diabetic macular edema (DME). The severity of DR and DME will be graded by the doctor according to the ''Early Treatment Diabetic Retinopathy Study'' (ETDRS) international classification standards.
15769488|NCT04699864|Diagnostic Test|Manual grading of DR and DME by CHUM ophthalmologists based on retinal photographies acquired by Diagnos|Ophthalmologists of the CHUM will revise the macula-centered eye color photos acquired by DIAGNOS in order to find lesions characteristics of diabetic retinopathy (DR) and diabetic macular edema (DME). The severity of DR and DME will be graded (blind assessment) according to the ''Early Treatment Diabetic Retinopathy Study'' (ETDRS) international classification standards.
15769489|NCT04699851|Behavioral|Tailored recommendations|Tailored informations delivered by email about health prevention behavior in a pandemic based on the answers in the survey.
15836327|NCT04154293|Drug|Isotretinoin|Topical Isotretinoin ointment
15769490|NCT04699851|Behavioral|General recommendation|The control group will receive general recommendations by email about health prevention in a pandemic.
15769496|NCT04699825|Other|Cardiovascular and immunological changes|performing cardiac ultrasound, vascular doppler, and immunological study on cord blood sample
15769497|NCT04699799|Other|Present odors to participants while recording brain activity|Present odors to participants while recording brain activity
15769498|NCT04699786|Other|Arm A and Arm B|Both Arms A and B will receive the same intervention, but at different time points. Both arms will be offered the option to learn their research results in personalized five-year risk estimate of getting Alzheimer disease dementia. Arm A participants will receive their risk estimate about two weeks after consent is signed and Arm B will receive their risk estimate about one year after consent is signed. The risk estimate returned to participants is based on research results from individual genotyping results, imaging testing and demographic characteristics. Both arms will complete psychosocial and cognitive testing. Also, surveys used in this study will ask about participants' experiences and feelings after learning participant's risk estimate. Arm A and Arm B will receive follow up surveys at one week post disclosure of the risk estimate, two months and six months post disclosure. Arm A will have extra surveys at fourteen and eighteen months post disclosure.
15769499|NCT04699773|Procedure|LITT|This procedure is done under MRI guidance and employs low-powered thermal energy to achieve tumor ablation through coagulation.
15769500|NCT04699773|Radiation|Hypofractionated Radiation Therapy|Treatments will be delivered once daily on consecutive treatment days (typically 5 fractions per week). Radiation therapy simulation is to be performed within 10 days of the LITT procedure.
15769501|NCT04699760|Dietary Supplement|Fish Oil|8 weeks, 2.2 G EPA/day
15769502|NCT04699760|Dietary Supplement|Placebo|Placebo
15769503|NCT04699747|Drug|F-18 3F4AP|Subjects will be injected once per imaging session (a maximum of 2 imaging sessions) with up to 10 mCi (±20%) of 18-F 3F4AP as a rapid intravenous bolus (within 1 min).
15769504|NCT04699734|Diagnostic Test|Xylocaine 1%|Nerve block
15769505|NCT04699734|Diagnostic Test|NaCl 9mg/ml|Nerve block
15769506|NCT04699721|Drug|nivolumab 4.5mg/kg+Paclitaxel (albumin-bound type) 260mg / m2+ Carboplatin AUC5|3 cycles of nivolumab+Paclitaxel (albumin-bound type)+ Carboplatin AUC5 (21 days/cycle); as well as BiFico (oral taking, 4 capsules/time, 2 times per day)
15769507|NCT04699708|Device|Carbon dioxide monitoring|Blinded recording of CO2 during preterm resuscitation.
15769508|NCT04699695|Other|Biologic therapy versus no biologic therapy|Biologic therapy administered per standard of care
15769509|NCT04699682|Other|Control|During follow-up visits, as part of this research, additional stool samples are taken every month (M1 to M12).
15769510|NCT04699682|Other|BHR Case|"During follow-up visits, compared to the usual management of patients with BHRe (monthly sampling for 6 consecutive months), additional samples are taken as described below:
~- stool samples taken at different times:
~every 7 days during the first month (M1)
~every 14 days for the following months until the end of the patient's participation (M2 to M12)."
15769511|NCT04699669|Drug|CBL-514, placebo|"One side of the abdominal region will receive CBL-514, while the other will receive placebo with equal volume.
~Which side of the abdominal region to receive CBL-514 or placebo would be randomized.
~No PK samples will be collected in this cohort."
15769512|NCT04699669|Drug|CBL-514, placebo|"One side of the abdominal region will receive CBL-514, while the other will receive placebo with equal volume.
~Which side of the abdominal region to receive CBL-514 or placebo would be randomized."
15769513|NCT04699669|Drug|CBL-514|Both sides of the abdominal region will receive CBL-514.
15769514|NCT04699656|Drug|Plazomicin Injection|single dose of plazomicin
15769515|NCT04699643|Drug|EVER4010001|Please refer to information in arm/group descriptions.
15769517|NCT04699617|Device|Dolphin 2.0|The Dolphin 2.0 is a platform that runs an immersive virtual reality software, based on an oceanic environment, where players control simulated creatures.
15769518|NCT04699604|Drug|Levocetirizine Dihydrochloride|At the end of the HILD assessment participants will be randomized to Levocetirizine Dihydrochloride or placebo. Children will be randomized by an investigational pharmacist to add-on either Levocetirizine dihydrochloride/ Xyzal® (UCB, Inc.) immediate release oral solution 2.5mg/5ml (2.5mg in children 6-11 years of age; 5mg in children >11 years per recommended doses) or placebo to their current asthma regimen.
15769519|NCT04699604|Drug|Placebo|Placebo
15769520|NCT04699591|Drug|Domperidone|Domperidone taken 4 times a day, dose based on body weight
15769521|NCT04699578|Diagnostic Test|Covid-19 positive|All pregnant women at any stage of pregnancy afferent to obstetrics services who tested positive in confirmation tests by nasopharyngeal swab for viral RNA detection through real-time reverse transcriptase - polymerase chain reaction (rRT-PCR) will be included.
15769522|NCT04699565|Diagnostic Test|Cardiac magnetic resonance|Evaluate the predictive value of myocardial viability measured with cardiac magnetic resonance for the identification of LV REM 6 months after STEMI
15769523|NCT04699552|Device|120W Lumenis Holmium:YAG laser 20J|120W Lumenis Holmium:YAG laser 20J
15769524|NCT04699552|Device|120W Lumenis Holmium:YAG laser 40 J|120W Lumenis Holmium:YAG laser 40J
15769525|NCT04699552|Device|120W Lumenis Holmium:YAG laser 60 J|120W Lumenis Holmium:YAG laser 60J
15769526|NCT04699539|Radiation|SBRT|SBRT: in 5-6fractions with Cyberknife.
15769527|NCT04699539|Drug|Chemotherapy|Gemcitabine (1000mg/m2，d1, 8) + albumin-bound paclitaxel (125mg/m2，d1, 8), repeat every 3 weeks.
15769528|NCT04699526|Other|Universal Prevention Curriculum Training for Schools|School administrators and teachers participated in UPC training and formed prevention leadership action teams
15769553|NCT04699318|Procedure|Group A|To release the pediatric hypospadias using Single Dartos Tubularized incised plate (TIP) Urethroplasty
15769554|NCT04699305|Device|ActiGraft|Whole blood clot (WBC) gel
15769555|NCT04699292|Procedure|Surgery|Surgery
15769556|NCT04699292|Radiation|Preoperative RT 36Gy|Preoperative radiotherapy to 36Gy (equivalent)
15769529|NCT04699513|Device|Mechanical Ventilation Mode (airway pressure release ventilation )|Airway pressure release ventilation (APRV) is a mode of mechanical ventilation that alternates between two levels of continuous positive airway pressure (CPAP) support and allows spontaneous respiratory effort at either CPAP level. It is considered as an alternative, life-saving modality in patients with acute respiratory distress syndrome (ARDS) that struggle for oxygenation.
15769530|NCT04699487|Device|Photobiomodulation|"Oral pads will be applied on irradiated areas presenting a risk of radiotherapy-related OM. In addition, a derma pad will be applied on the anterior face of the neck to protect the oropharynx from OM.
~The dose to be delivered, at each session and each applied area, has been set at 3 J/cm². In case a lesion appears, the dose will be increased to 6J/cm² for curative treatment.
~Treatment with CareMin650 must start on the first day of radiotherapy and will be administered during the whole radiotherapy period, ideally 5 days/week, at least 3 days/week, ideally before the radiotherapy session."
15769531|NCT04699474|Device|Leg ergometer|Leg cycling in bed using motorized ergometer
15769532|NCT04699461|Drug|Loncastuximab Tesirine|IV infusion
15769533|NCT04699461|Drug|Idelalisib|Oral tablet
15769534|NCT04699448|Other|Nutritional intervention.|Diets designed for body weight loss, based on different macronutrient content.
15769535|NCT04699435|Other|Control|"All patients are installed with a 30 ° proclive and have pre-oxygenation (FiO2 = 1) with a face mask. At the end of the 3-minute pre-oxygenation for the Control group, the values of ORI, SpO2, mean arterial pressure and heart rate are recorded."
15769536|NCT04699435|Other|PreOx_3min|"Patients with a BMI between 30 kg / m² and 40 kg / m² are distributed according to a random allocation in the group PreOx_3min.
~All patients are installed with a 30 ° proclive and have pre-oxygenation (FiO2 = 1) with a face mask. At the end of the 3-minute pre-oxygenation for the PreOx_3min group, the values of ORI, SpO2, mean arterial pressure and heart rate are recorded."
15769537|NCT04699435|Other|PreOx_6min|"Patients with a BMI between 30 kg / m² and 40 kg / m² are distributed according to a random allocation in the group PreOx_6min.
~All patients are installed with a 30 ° proclive and have pre-oxygenation (FiO2 = 1) with a face mask. At the end of the 6-minute pre-oxygenation for the PreOx_3min group, the values of ORI, SpO2, mean arterial pressure and heart rate are recorded."
15769538|NCT04699422|Procedure|Serratus anterior plane block|The needle will be introduced in-plane from supero-anterior to postero-inferior until the needle tip is positioned in the plane underneath the serratus muscle (deep compartment). Under continuous ultrasound guidance,30 cc Bupivacaine 0.25% will be injected in the deep compartment. After the deep component of the SAP is completed, the needle will be withdrawn to the subcutaneous tissues. The needle will be flattened and advanced in-plane to the plane superficial to the serratus muscles. 10 cc Bupivacaine 0.25% will be injected superficial to the serratus muscles after correct placement of the needle tip is confirmed on ultrasound
15769539|NCT04699422|Drug|PCIA with Piritramide|A patient controlled intravenous analgesia system (IVAC PCAM®, Cardinal Health or CADD pump) with piritramide (Dipidolor®, Janssen) using following settings: bolus 2 mg and lockout interval 15 min.
15769540|NCT04699409|Other|stroke educational campaign: FAST|After randomization, study staff provided 15-minute education on the selected campaign to each individual participant using educational pictures.
15769541|NCT04699409|Other|stroke educational campaign: STROKE 112|After randomization, study staff provided 15-minute education on the selected campaign to each individual participant using educational pictures.
15769542|NCT04699396|Procedure|Mobilisation With Movement 1|"Application of a sustained passive accessory movement to a joint (talus or fibula) while the patient actively performs a forward lean/lunge that was previously limited.
~3 sets of 10 repetitions of a glide applied to the talus were performed, followed by 3 sets of 10 repetitions of a glide applied to the fibula."
15769543|NCT04699396|Procedure|Mobilisation With Movement 2|"Application of a sustained passive accessory movement to a joint (talus or fibula) while the patient actively performs a forward lean/lunge that was previously limited.
~3 sets of 10 repetitions of a glide applied to the fibula were performed, followed by 3 sets of 10 repetitions of a glide applied to the talus."
15769544|NCT04699396|Other|Placebo|The Placebo group participants performed the same number of sets and repetitions (6 sets of 20 repetitions) of lean/lunge forward into dorsiflexion, without any glide application.
15769545|NCT04699383|Drug|Sodium Stibogluconate with allopurinol|Routine administration of SSG/allopurinol combination treatment, from 1-5 cycles
15769546|NCT04699370|Other|cognition-targeted exercise|"All Standardized physical therapy exercises will be performed in a time-contingent .
~Goal setting is essentially done together with the patient, focussing on functionality instead of fatigue relief. Progression to a next level of (more difficult) exercises will be preceded by an intermediate phase of motor imagery.
~The treating physical therapist will be advised to address patients' cognitions about their problems during the cognition-targeted exercise training, so that patients will have positive perceptions regarding their illness and treatment outcome.
~The treating physical therapist will be advised to discuss the patient's perceptions about each exercise. This include discussion of the anticipated consequences of the exercises and challenging the patient's cognitions in relation to the exercises"
15769547|NCT04699370|Behavioral|Cognitive behavioral therapy|In the first and second sessions, patients will learn about fatigue-related symptoms as well as Cognitive behavioral therapy and its effectiveness. The third and fourth sessions will be devoted on the introduction of behavioral strategies. The fifth session will introduce cognitive strategies to decrease fatigue. The last three sessions will be about how to adopt the proposed strategies consistently.
15769548|NCT04699370|Other|Standardized physical therapy|The standardized physical therapy will consist of eight half-hour individualized face to face physiotherapy sessions, over a 4-week period. this program will consist of twice-weekly supervised general aerobic, strengthening and flexibility exercise sessions .This exercise program is reflective of the general exercises typically undertaken within routine clinical practice.
15769549|NCT04699357|Drug|Atropine|different concentrations (0.01%/0.04%/0.1%) of atropine were administered to high myopic children
15769550|NCT04699344|Diagnostic Test|The level of CNV|The extracted DNA from morning urine will be analyzed by PROUD to determine the level of CNV.
15769551|NCT04699331|Device|Transcranial Direct Current Stimulation|Transcranial direct current stimulation is a form of noninvasive neuromodulation that uses constant and low direct current delivered via electrodes on the scalp.
15769552|NCT04699318|Procedure|Group B|To release the pediatric hypospadias using Double Dartos Tubularized incised plate (TIP) Urethroplasty
15769557|NCT04699292|Radiation|Preoperative RT 50Gy|Preoperative radiotherapy to 50Gy (equivalent)
15769558|NCT04699292|Radiation|Postoperative RT 50-66Gy|Postoperative radiotherapy to 50-66Gy (equivalent)
15769559|NCT04699292|Radiation|RT 36Gy|Definitive radiotherapy to 36Gy (equivalent)
15769560|NCT04699279|Drug|Rosuvastatin 10mg|Rosuvastatin 10mg is taken by oral or nasal feeding every day at ang time.
15769561|NCT04699266|Device|Assigned Intervention (POD F GF)|The investigational lens (POD F GF )will be implanted to both eyes in subjects with bilateral cataract. Registration of patients and the implantation of the investigational lens (POD F GF) will be conducted in consideration of securing 44 eyes in 22 subjects as the analysis subjects
15769562|NCT04699253|Device|SanaCoach Heart failure|Patients will be using the SanaCoach heart failure for at least 6 months during the study period. SanaCoach heart failure is a web application that will be guiding the patient through a regular, systematic assessment of patient's health and wellbeing as well as regular education sessions. The assessment frequency ranges from daily to monthly, based on the settings provided by the health care provider. Furthermore, it provides a repository for patient's care plan to give insight into the course and treatment of the disorder and offers the possibility to contact the health care provider through the web application.
15769563|NCT04699240|Drug|clotrimazole vaginal tablets|Intensive treatment: clotrimazole vaginal tablets 500mg, every 72 hours, three consecutive times Consolidation treatment: clotrimazole vaginal tablets 500mg, once a week, 6 months
15769564|NCT04699240|Drug|Clotrimazole vaginal tablets+ Lactobacillus|Intensive treatment: clotrimazole vaginal tablets 500mg, every 72 hours, three consecutive times Consolidation treatment: clotrimazole vaginal tablets 500mg, once a week, 6 months Human Reproductive Tract Active Lactobacillus,4g,qd ,3months
15769565|NCT04699227|Procedure|Cuff application with inflation|The blood pressure cuff will be placed on the arm and inflated.
15769566|NCT04699227|Other|Sham inflation|The blood pressure cuff will be placed on the arm and not inflated.
15769567|NCT04699214|Drug|Endostar (recombinant human endostatin injection)|The experimental group is Endostar combined with AI
15769568|NCT04699214|Drug|Chemotherapy AI|AI: Doxorubicin (ADM) 60mg/m2 iv D1+ Ifosfamide (IFO) 2g/m2/d D1-5+ Mesna 400mg/m 2 (ifosfamide start infusion, time after infusion 4 hours, 8 hours injection) D1-5, Q3W
15769569|NCT04699201|Procedure|Hincisional hernia prevention by onlay prosthesis trocar closure|Hincisional hernia prevention by onlay prosthesis trocar closure
15769570|NCT04699201|Procedure|laparoscopic cholecystectomy|Laparoscopic cholecystectomy with or without common bile duct exploration
15769571|NCT04699201|Diagnostic Test|Abdominal ultrasound|Ultrasound focused in abdominal wall defects on the trocar incisions, 12 months after the surgery
15769572|NCT04699188|Drug|JDQ443|KRAS G12C inhibitor
15769573|NCT04699188|Drug|TNO155|SHP2 inhibitor
15769574|NCT04699188|Biological|spartalizumab|Anti PD1 antibody
15769575|NCT04699175|Drug|HR021618|Treatment group A:HR021618; high dose
15769576|NCT04699175|Drug|HR021618|Treatment group B:HR021618; low dose
15769577|NCT04699175|Drug|Placebo|Treatment group C: HR021618 blank preparation.
15769578|NCT04699149|Other|Transcranial magnetic stimulation|Non-invasive brain stimulation
15769579|NCT04699149|Other|Sham transcranial magnetic stimulation|Non-invasive brain stimulation
15769581|NCT04699123|Drug|NC318|NC318 will be given intravenously (IV) every 2 weeks for patients receiving combination therapy treatment or weekly for patient receiving NC318 in monotherapy.
15769582|NCT04699123|Drug|Pembrolizumab|Pembrolizumab 200 mg will be given IV every 3 weeks
15769583|NCT04699110|Drug|Adrenaline|Treatment group will receive adrenaline (100 to 400 mcg) for the treatment of No-reflow
15769584|NCT04699110|Drug|Adenosine|Control group will receive adenosine (100 to 400 mcg)
15769585|NCT04699097|Drug|Azithromycin|250 mg tablet, 5 ml / 200 mg 30 ml suspension
15769586|NCT04699084|Other|Mozart music|A 20-minute piece composed by W.A Mozart ( Sonata K. 448 in D Major for 2 pianos) was applied in music group, directly after the arrival of patients in the Post Anesthesia Care Unit (PACU), while they were receiving usual postoperative care.
15769588|NCT04699058|Diagnostic Test|COVID-antibody test|Questionnaire and COVID-antibody test for all participants
15769589|NCT04699045|Other|No active intervention|
15769591|NCT04699019|Other|Four speeds|Four speeds ranging from a set walking speed up to 9 mph
15769592|NCT04699019|Other|Foot Strike Pattern|Foot strike sequences (rearfoot strike, midfoot strike, forefoot strike)
15769593|NCT04698993|Diagnostic Test|Dräger Antigen Test SARS-CoV-2|Collection of patient samples using the Dräger sample collector with subsequent test reading via the Dräger Antigen SARS-CoV-2 Test
15769594|NCT04698980|Diagnostic Test|blood samples (venous and capillary at the fingertip)|For each participant, the intervention will be a fingertip sample to perform the STANDARD G6PD test and two blood samples on EDTA to perform the reference test
15769595|NCT04698967|Behavioral|Career Counseling & Development for Veterans|An eight week intervention delivered via weekly individual counseling sessions. The intervention consists of the following topics: Identifying career-related problems; Work needs assessment; Career uncertainty; Career adaptability; Critical consciousness; Work volition; Behavioral activation; Warm hand-offs.
15769596|NCT04698967|Behavioral|Transitional Work Experience|Provides Veterans with immediate access to a non-competitive, paid job contracted by the VA. Positions are typically housed within a VA hospital (e.g., housekeeping, grounds, kitchens, and construction), but are sometimes located in the community. TWE is time-limited. TWE is staffed by vocational rehabilitation specialists (VRS).
15769711|NCT04698096|Other|Medical examination|Blood pressure measurement, abdominal and thoracic physical examination
15769597|NCT04698954|Behavioral|Adherence Improving self-Management Strategy|The AIMS intervention is a conversation between a patient and a trained nurse, imbedded in the usual care. It consists of structured modules with visual materials, developed based on a sound understanding of the factors that drive non-adherence and potent behaviour change techniques to modify those. These modules aim to enhance patient knowledge, motivation, self-efficacy, and skills for self-managing their treatment. As part of the intervention, patients use electronic monitors to track their own behaviour, namely a medication and a physical activity monitor. Together with the nurse they examine these results to identify adherence problems and solutions and make a plan.
15769598|NCT04698954|Other|Treatment-as-usual|Participants in the control group will receive treatment as usual. They will visit the nurse in the out patient clinic each 3 or 6 months for 30 minutes.
15769599|NCT04698941|Drug|Albumin Paclitaxel|Albumin Paclitaxel intravenous infusion was administered at a dose of 260 mg/m^2 on Day 1 of each 21-day cycle.
15769600|NCT04698941|Drug|Simvastatin|20mg daily oral tablet taken.
15769601|NCT04698928|Device|Theta burst stimulation|Theta burst stimulation over SMA. 3 section per day, for 5 days, total 15 sections.
15769602|NCT04698915|Drug|Drug GC4711|15 Minute IV Infusion
15769603|NCT04698915|Drug|Placebo|15 Minute IV Infusion
15769604|NCT04698902|Device|Intracoronary lithotripsy|Intracoronary lithotripsy involves the use of sonic pressure waves generated from emitters enclosed within a balloon delivery system. The generated sonic waves act to fracture calcium within the coronary artery wall.
15769605|NCT04698889|Dietary Supplement|natural cow|
15769606|NCT04698889|Dietary Supplement|high protein cow milk|
15769607|NCT04698889|Dietary Supplement|natural human|
15769608|NCT04698889|Dietary Supplement|low protein cow milk|
15769609|NCT04698876|Procedure|Self-tonometry by means of ICareHOME|Outpatient measurement of intraocular pressure at home
15769610|NCT04698876|Procedure|Intraocular measurement by means of rebound tonometry or Goldmann applanation tonometry|Stationary measurement of intraocular pressure in a clinic
15769611|NCT04698876|Procedure|Blood pressure|Blood pressure measurement for 24 h
15769612|NCT04698863|Device|Oxygen reserve index|eveluating oxygen reserve in blood
15769613|NCT04698850|Drug|Aflibercept 40 MG/ML [Eylea]|Patients will be receiving intravitreal aflibercept starting with 3 monthly doses and continuing with treat-and-extend regimen with minimal interval of 8 week and maximum interval of 16 week. Interval can be prolonged or shortened by 2 or 4 weeks based on the disease activity and BCVA..
15769614|NCT04698850|Drug|Brolucizumab-Dbll 120 MG/ML [Beovu]|Patients will be receiving intravitreal brolucizumab starting with 3 monthly doses followed by the treatment interval of 8 or 12 weeks based on the disease activity and BCVA.
15769615|NCT04698850|Drug|Ranibizumab 6 MG/ML [Lucentis]|Rescue therapy for patients with study drug related adverse events or with worsening of BCVA and OCT finding even on the shortest treatment interval when resistance to study drug is suspected.
15769616|NCT04698824|Procedure|Hypnosis session|"At least one session of hypnosis in the internal medicine unit at the hospital Groupe Hospitalier Mutualiste de Grenoble"
15769617|NCT04698811|Behavioral|VIRTUAL ENEAGRAM|"Presentation of the Virtual Enneagram and its content and realization of the first battery of tests (World Health Organization Quality of Life - (WHOQOL-BREF). Stress Perception Scale 10 (EPS-10) The Trait-State Anxiety Inventory: IDATE E and T.) .
~Guidance and training on personality and the Enneagram, its classification system, personality subtypes and dynamics of stress and growth allowing self-recognition.
~Second test battery ((World Health Organization Quality of Life - (WHOQOL-BREF). Stress Perception Scale 10 (EPS-10) The Trait-State Anxiety Inventory: (IDATE E and T.) and Enneagram Questionnaire."
15769618|NCT04698798|Procedure|Muscle Biopsy|Patients will be treated for SARS-CoV-2 symptoms on the intensive care unit. During this treatment two muscle biopsies will be obtained with an interval of seven days between them.
15769619|NCT04698785|Drug|Treatment by regorafenib and best supportive care|Treatment for 13 cycles (12 months) maximum. During each cycle, patient will take 3 tablets, once a day, corresponding to a total of 120 mg Regorafenib, during 21 days, followed by 7 days without treatment.
15769620|NCT04698785|Drug|Treatment by placebo and best supportive care|Treatment for 13 cycles (12 months) maximum. During each cycle, patient will take 3 tablets, once a day, corresponding to a total of 120 mg Regorafenib, during 21 days, followed by 7 days without treatment.
15769621|NCT04698772|Drug|Ketamine|Blinded study group will receive ketamine for pain control (0.3 mg/kg IV over 3-5 minutes)
15769622|NCT04698772|Drug|Morphine|Blinded study group will receive morphine 4 mg IV push over 3-5 minutes for pain control
15769623|NCT04698759|Other|No Intervention|no Intervention
15769624|NCT04698746|Procedure|Pericapsular nerve group block|PENG block will be made with 10 ml 0.5% bupivacaine + 2 mg dexamethasone + 9.5 ml NaCl under US-guidance
15769625|NCT04698746|Procedure|Intra-articular local anesthetic injection|Intra-articular local anesthetic injection will be made with 10 ml 0.5% bupivacaine + 2 mg dexamethasone + 9.5 ml NaCl
15769626|NCT04698733|Device|BEST™ HVPC microcurrent electrical stimulation Pro-Sport Ultra® device|"Participants will receive two (2) 20-minute treatments a week on nonconsecutive days for 6 weeks in the clinic. At the end of 6 weeks, participants will have a 6-week pause in treatment.
~Active Avazzia PRO-Sport Ultra® medical device, BEST™ HVPC microcurrent electrical stimulation, FDA cleared for pain relief"
15769627|NCT04698720|Behavioral|Muscle Relaxation with Guided Imagery|Relaxation intervention session begins with diaphragmatic breathing, followed by Jacobson's progressive muscle relaxation, which involves the contraction and subsequent relaxation of the 16 muscle groups of the body (forearm, arm, upper forehead, eye, mouth, jaw and throat, neck, shoulder, chest, stomach, thigh, leg and foot).The contraction is performed for 7 seconds while the relaxation lasts for about 40 to 50 seconds.The relaxation of the foot muscle group is only performed on the healthy foot, because dressing and bandages may bandage the foot with the DFU, which together with the typical joint stiffness of the diabetic foot, make it difficult to perform. After muscle relaxation, begins the guided imagery focused on DFU healing. The patient is instructed to think about his/her current state of health and to imagine the DFU as a dark area and the healing relaxation as a light associated to pleasant sensations, which will focus on the foot with DFU to heal it.
15769678|NCT04698278|Device|PanOptix Trifocal Intraocular Lens|This is a FDA approved trifocal lens that will be placed in patients who have had previous myopic LASIK or PRK.
15836328|NCT04154293|Other|Vehicle|Topical Vehicle Ointment
15769628|NCT04698720|Behavioral|Hypnosis with Guided Imagery|"In the beginning of the first session we apply the Eye-Roll Test for Hypnotizability of Herbert Spiegel. Each session follows the Hypnotic Protocol with the following steps:Pre-talk/Absortion/Ratification/Aliciation/Dissociation/Awakening.
~The four sessions train the participants in visual, auditory and kinesthetic perception on ulcer healing. The protocol also promotes medical treatment acceptance."
15769629|NCT04698720|Behavioral|Neutral Guided Imagery|This placebo consists on neutral guided imagery focused on themes of the patient's daily life before having DFU. Each session has a theme associated with the patient's life - family, work, friends and leisure. Initially, the patient is asked to think about an event related to the theme of the session of his/her choice, be it positive or negative, which occurred before patient has the current DFU. Then, questions are asked which allow a more detailed reconstruction of the event and the patient is asked to imagine according only to the instructions given. When the whole episode is remembered, the patient is asked to tell what he or she imagined/remembered in each of the questions given.
15769630|NCT04698707|Other|Vascularized lymph node flap transfer|Patients who have received VLNT as their primary treatment but with minimal improvement
15769631|NCT04698707|Other|Patients without prior lymphedema surgery|Patients without prior lymphedema surgery
15769632|NCT04698694|Device|Electroporation with voltage amplitude of 40 V (corresponding to an electric field strength of 100 V/cm)|The physician will select the voltage amplitude of 40 V to be given to the subject based on a randomization list, while the subject will remain blind to the voltage he/she is assigned to. The electroporation will be performed with a EPS electrode gun.
15769633|NCT04698694|Device|Electroporation with voltage amplitude of 60 V (corresponding to an electric field strength of 150 V/cm)|The physician will select the voltage amplitude of 60 V to be given to the subject based on a randomization list, while the subject will remain blind to the voltage he/she is assigned to. The electroporation will be performed with a EPS electrode gun.
15769634|NCT04698681|Diagnostic Test|Liquid Biopsy NGS Test|Ct-DNA from blood samples collected from eligible patients will be analyzed using NGS for the presence of mutations in either the NRF2/NFE2L2 or KEAP1 genes.
15769635|NCT04698668|Device|fusion imaging|To drain a pancreatic fluid collection through the assitance of the CT-scan image that is superimposed on the radiological field
15769636|NCT04698655|Other|Information on treatment options|"Asked to read two A4 pages of information on treatment options (osteoarthritis treatment options)"
15769637|NCT04698655|Other|Recommendation from general practitioner|Receive a hypothetical general practitioner recommendation for exercise
15769638|NCT04698655|Other|Information on osteoarthritis|Asked to read 1 A4 page of brief information on osteoarthritis
15769639|NCT04698642|Drug|CBL-514|Both sides of the abdominal region will receive CBL-514.
15769640|NCT04698603|Drug|5 Methoxy N,N Dimethyltryptamine|GH001 administered via inhalation
15769641|NCT04698590|Device|Wavefront Guided Scleral Lenses|Custom wavefront guided, higher order aberration correcting scleral lenses
15769642|NCT04698590|Device|Traditional Scleral Lenses|Traditional scleral lenses
15769643|NCT04698577|Behavioral|Attention Training|The training was delivered face-to-face in groups of three participants. Participants were involved in a game of table tennis with two players and one spectator. The roles were rotated every 5 minutes so that each participant experienced 10 minutes of play and 5 minutes of observation. The game was played as normal with one point awarded to the player for every score achieved. All 3 players were asked to keep the score of the game in their minds during each 5-minute round. Participants had two objectives 1) to play and win the game and 2) to silently keep the score of the game. The researcher watched the game and accurately kept score, using a notepad. At the end of every 5-minute round, the researcher paused play and asked each child to write down the score they were holding in their mind. The researcher then revealed the true score, asked participants to swap roles and commence another round.
15769644|NCT04698577|Behavioral|Active Control|The control group was the same as the training group except for the core training mechanism; children were not required to mentally keep score. The researcher kept score by continually calling out the updated score as each point was won. The observing child was simply told to wait his/her turn.
15769645|NCT04698564|Drug|Hyperpolarized 13C-Pyruvate|"Hyperpolarized Pyruvate (13C) Injection, containing spin-polarized (hyperpolarized) [ 13C]pyruvate, is being studied as a diagnostic agent in combination with 13C spectroscopic MR imaging. The aim is to visualize [13C]pyruvate and its metabolites and thereby distinguish between anatomical areas with normal vs. abnormal metabolism, which should be useful in diagnosing and characterizing, for example, malignancy.
~Hyperpolarized Pyruvate (13C) Injection and [13C]pyruvate are general terms used throughout this brochure, that refer to all 13C labeling patterns, such as [1- 13C]pyruvate, [2- 13C]pyruvate and [1,2- 13C]pyruvate. From biological and safety standpoints, pyruvate with each of the labeling patterns behaves identically in the human body [Koletzko et al., 1997]."
15769646|NCT04698551|Genetic|Non invasive prenatal diagnosis|Search for the familial mutation involved in DPN requests from phasing of parental haplotypes by 3rd generation long-fragment DNA sequencing techniques coupled with targeted sequencing of free circulating DNA from maternal plasma.
15769647|NCT04698538|Behavioral|JASPER|JASPER is a naturalistic, developmental, behavioral intervention (NDBI) that focuses on developing social communication and language skills in the context of a play based intervention.
15769648|NCT04698525|Drug|Valproate Sodium|Comparison between two actives
15769649|NCT04698525|Drug|Memantine|Memantine
15769650|NCT04698512|Device|AVFistuloplasty with Sirolimus coated balloon|After an initial fistulogram, the lesion will first be predicated with standard high pressure balloon, followed by MagicTouch™ Sirolimus drug coated balloon
15769651|NCT04698499|Other|Swallowing exercise from home|Treatment Arm A will consist of using pen and paper to complete the exercises. This is considered standard care. Treatment Arm B will consist of using Mobili-T to complete the exercises.
15769652|NCT04698486|Other|Hyperinsulinemic euglycaemic clamp|"Infusion of constant intravenous insulin to achieve hyperinsulinemia and concomitant infusion of glucose to maintain euglycemia (plasma glucose at 5 mM).
~Infusion of palmitate and VLDL-triglyceride tracer. PET/CT scans of heart and liver, both in basal period and during intervention."
15769653|NCT04698473|Other|NCPAP|NCPAP infants will be randomized into two different non invasive ventilation groups
15769654|NCT04698473|Other|NIPPV|NIPPV NCPAP infants will be randomized into two different non invasive ventilation groups
15836828|NCT04150289|Drug|Farydak|non-interventional study
15769655|NCT04698460|Procedure|Hybrid coronary revascularization|A staged procedure with a minimally invasive direct coronary artery bypass grafting of left anterior descending artery by left internal mammary artery (LIMA-LAD MIDCAB) at first stage, and percutaneous stenting of iFR-significant lesions in non-LAD arteries at the second stage
15769656|NCT04698460|Procedure|Coronary artery bypass grafting|A conventional procedure of median thoracotomy with on-pump bypass grafting of left anterior descending artery by left internal mammary artery and saphenous vein grafting of circumflex and/or right coronary artery
15769657|NCT04698447|Dietary Supplement|Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_MetS|20 eligible subjects with the metabolic syndrome (MetS) will take natural supplement containing a spray-dried formulation of citraVes™, directly in the mouth, without water, to be dissolved preferably under the tongue, at a stable dose of one sachet a day (1000 mg/day) for 6 months and as add-on therapy to the ongoing treatment, maintained at fixed doses for the entire study.
15769658|NCT04698447|Dietary Supplement|Placebo (without any active ingredients)|20 eligible subjects with the metabolic syndrome will take placebo in a spray-dried formulation (without any active ingredients) directly in the mouth, without water, to be dissolved preferably under the tongue, at a stable dose of one sachet a day for 6 months, as add-on therapy to the ongoing treatment, maintained at fixed doses for the entire study.
15769659|NCT04698447|Dietary Supplement|Natural supplement containing nanovesicles delivered from Citrus Limon (L.) juice_HS|20 eligible healthy subjects (HS) will take natural supplement containing a spray-dried formulation of citraVes™, directly in the mouth, without water, to be dissolved preferably under the tongue, at a stable dose of one sachet a day (1000 mg/day) for 6 months, maintained at fixed doses for the entire study.
15769660|NCT04698434|Drug|Esketamine|each group was given a single intravenous dose of the corresponding esketamine.
15769661|NCT04698421|Biological|Blood collection on admission and longitudinally|Biological samples will be collected in the normal diagnosis and follow-up process. Only blood will be taken in larger quantity (6 tubes of 7mL).
15769662|NCT04698408|Other|high-protein, carbohydrate-reduced diet|the high-protein, carbohydrate-reduced diet will consist of 1.2-1.4 g/kg/d protein, 26-20en% carbohydrates and +/- 50en% fatty acids, with mainly unsaturated fatty acids. This diet consist of mainly unprocessed, fresh nutrient-dense food-products. Ultra-processed foods and alcoholic beverages will be totally avoided. Salt consumption will not exceed 5-6 g/d. The diet is ad libitum and caloric restriction will not be applied. The diet will be followed for 6 weeks.
15769663|NCT04698408|Other|Dutch Nutritional Guidelines|the diet according to the Dutch Nutritional Guidelines will consist of a protein intake of 0.8-1.0 g/kg/d and 50-60en% carbohydrates, and +/-30en% fatty acids, with restriction of saturated fatty acids <10en%. This diet consist of mainly unprocessed, fresh nutrient-dense food-products. Ultra-processed foods and alcoholic beverages will be totally avoided. Salt consumption will not exceed 5-6 g/d. The diet is ad libitum and caloric restriction will not be applied. The diet will be followed for 6 weeks.
15769664|NCT04698395|Behavioral|Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)|motor learning-based, intensive therapy for children with cerebral palsy
15769665|NCT04698395|Behavioral|Regular care|customary or usual care given to any infant/toddler with cerebral palsy
15769666|NCT04698369|Device|Vibration Massage Therapy|WearUL is a patent pending wearable rehabilitation technology that targets localized vibration massage therapy directly onto the body. The frequency and amplitude combinations to be delivered by WearUL are safe and effective in clinical and research settings based on previous studies on focal vibration.
15769667|NCT04698356|Behavioral|Auditory-cognitive training paradigm|The investigators developed an American English version of the Nottingham (UK) PLUS training paradigm in which listeners are asked to focus and listen to one speaker while ignoring another speaker. The paradigm is designed to optimally enhance the possibility of benefit: an adaptive procedure is employed in order to train each individual at their own level and to make the task challenging. A short-term memory component was also added to the original training paradigm, to enhance the cognitive skills of our participants. To provide maximal speech-in-noise benefit for older, normal-hearing adults, a validation of our new training materials is required. The investigators will evaluate this in young, normal-hearing adults (18-30 years) by studying our outcome measure (speech reception threshold) for the different sentence-scenarios and test-retest sessions.
15769668|NCT04698343|Device|Noninvasive Peripheral Nerve Stimulation (NPNS)|NPNS device programmed to deliver active stimulation.
15769669|NCT04698330|Drug|Berberine|0.6g (6 pills) of Berberine tablets administered twice a day orally before meal for 3 months
15769670|NCT04698330|Drug|Inulin|0.6g (6 pills) of Inulin tablets administered twice a day orally before meal for 3 months
15769671|NCT04698330|Drug|Berberine placebo tablets|0.6g (6 pills) of Berberine placebo tablets administered twice a day orally before meal for 3 months
15769672|NCT04698330|Drug|Inulin placebo tablets|0.6g (6 pills) of Inulin placebo tablets administered twice a day orally before meal for 3 months
15769673|NCT04698317|Procedure|open flap debridement|Open flap for removal of diseased periodontal tissues and necrotic cementum
15769674|NCT04698317|Other|use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate plus concentrated growth factors|use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate incorporating Concentrated Growth Factors in Periodontal Defect
15769675|NCT04698317|Other|use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone|use of Biodegradable Gelatin Sponge loaded with Beta-tricalcium Phosphate alone in the Intrabony Periodontal Defect
15769676|NCT04698304|Procedure|endovascular treatment|All the patients are treated by endovascular therapy, through contralateral femoral artery approach, ipsilateral antegrade femoral artery approach or brachial artery approach. If the lesion is difficult to pass in antegrade approach, retrograde puncture at the distal artery of the lesion can be performed. Surgeons can choose treatment methods according to the characteristics of the lesions. For example: (a) Plain old balloon angioplasty; (b) Drug-coated balloon angioplasty; (c) Drug-coated balloon angioplasty + provisional stenting; (d) Bare-metal stent implantation; (e) Stent graft implantation; (f) Directional atherectomy + drug-coated balloon angioplasty, (g) Drug -eluting stent.
15769677|NCT04698291|Procedure|Blood Donation|The blood donation will take place at the Gene & Health clinical assessment centre facilities. A trained member from Gene & Health program will be responsible for taking the blood samples.
15769710|NCT04698096|Other|Questionnaire|Anamnestic questionnaire, 3-day food questionnaire, Food Frequency Questionnaire
15769679|NCT04698265|Biological|Human amniotic suspension allograft (ASA)|Human amniotic suspension allograft (ASA) intra-articular injection.
15769680|NCT04698252|Radiation|Radiotherapy|Radiation therapy for oligometastatic sites
15769681|NCT04698252|Procedure|Surgery|Surgery for oligometastatic sites
15769682|NCT04698252|Other|Radiofrequency ablation|Radiofrequency ablation for oligometastatic sites
15769683|NCT04698239|Device|LASER MILESMAN 445 NM|Laser application
15769684|NCT04698226|Procedure|25-gauge pars plana vitrectomy with complete internal limiting membrane peeling and SF6 tamponade|Standard 3 port 25-gauge pars plana vitrectomy with complete internal limiting membrane peeling around the macular hole after brilliant blue dye staining and sulfur hexafluoride (SF6) tamponade
15769685|NCT04698226|Procedure|25-gauge pars plana vitrectomy with inverted flap technique and SF6 tamponade|"Standard 3 port 25-gauge pars plana vitrectomy with inverted flap technique after brilliant blue dye staining and SF6 tamponade. Flower petal type of inverted flap will be performed - multiple small ILM flaps will be created around the macular hole and placed over the macular hole."
15769686|NCT04698213|Drug|Axitinib Oral Tablet|"Axitinib is an orally bioavailable tyrosine kinase inhibitor currently approved in EU for treatment of patients affected by metastatic renal cell carcinoma (mRCC) progressed after another anti VEGFR-tyrosine kinase inhibitor (TKI).
~Axitinib inhibits the proangiogenic cytokines vascular endothelial growth factor (VEGF) and platelet-derived growth factor receptor (PDGF), thereby exerting an anti-angiogenic effect."
15769687|NCT04698213|Drug|Avelumab|Avelumab is a human immunoglobulin G1 (IgG1) monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein, with potential immune checkpoint inhibitory and antineoplastic activities. Upon administration, avelumab binds to PD-L1 and prevents the interaction of PD-L1 with its receptor programmed cell death protein 1 (PD-1). This inhibits the activation of PD-1 and its downstream signaling pathways. This may restore immune function through the activation of cytotoxic T lymphocytes (CTLs) targeted to PD-L1-overexpressing tumor cells. In addition, avelumab induces an antibody-dependent cellular cytotoxic (ADCC) response against PD-L1-expressing tumor cells. PD-1, a cell surface receptor belonging to the immunoglobulin superfamily expressed on T cells, negatively regulates T-cell activation and effector function when activated by its ligand, and plays an important role in tumor evasion from host immunity.
15769688|NCT04698200|Other|Cold exposure|Whole body resting cold (+10 degrees centigrade) and heat (+40 degrees centigrade) for 60 minutes.
15769691|NCT04698174|Procedure|Transepithelial Photorefractive keratectomy (tPRK) without laser polishing|Transepithelial Photorefractive keratectomy (tPRK) with laser ablation of the corneal epithelium and stroma in a single-step procedure using the B+L Teneo 317 Model 2 Excimer Laser.
15769692|NCT04698174|Procedure|Transepithelial Photorefractive keratectomy (tPRK) with laser polishing|Transepithelial Photorefractive keratectomy (tPRK) using the B+L Teneo 317 Model 2 Excimer Laser with end-treatment laser polishing using a fixed thickness of the additional layer of 5 μm.
15769693|NCT04698174|Procedure|Standard Photorefractive keratectomy (PRK)|Conventional Photorefractive keratectomy (PRK) with alcohol-assisted epithelium ablation. Then the aspheric ablation profile will be performed using the B+L Teneo 317 Model 2 Excimer Laser.
15769694|NCT04698161|Other|Biological sample collection|Collection of faeces, coproculture examination, urine, saliva, PBMC and blood for biobanking, to evaluate the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile, and to perform routine screening. Analysis for the identification, quantification and characterization of health-promoting bacteria
15769695|NCT04698161|Other|Questionnaire|Anamnestic questionnaire, 3-day food questionnaire, Food Frequency Questionnaire
15769696|NCT04698161|Other|Medical examination|Blood pressure measurement, abdominal and thoracic physical examination
15769697|NCT04698148|Other|Biological sample collection|Collection of faeces, coproculture examination, urine, saliva, PBMC and blood for biobanking, to evaluate the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile, and to perform routine screening. Analysis for the identification, quantification and characterization of health-promoting bacteria
15769698|NCT04698148|Other|Questionnaire|Anamnestic questionnaire, 3-day food questionnaire, Food Frequency Questionnaire
15769699|NCT04698148|Other|Medical examination|Blood pressure measurement, abdominal and thoracic physical examination
15769700|NCT04698135|Other|Biological samples collection|Collection of faeces, coproculture examination, urine, saliva, PBMC and blood for biobanking, to evaluate the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile, and to perform routine screening. Analysis for the identification, quantification and characterization of health-promoting bacteria
15769701|NCT04698135|Other|Questionnaire|Anamnestic questionnaire, 3-day food questionnaire, Food Frequency Questionnaire
15769702|NCT04698135|Other|Medical/laboratory examinations|Blood pressure measurement, abdominal and thoracic physical examination, body composition through bioimpedance analysis and metabolic, cardiovascular and respiratory variables; OGTT 75gr for blood glucose and insulin at times 0, 30, 60, 90 and 120', and a nocturnal oximetry and subsequently, if necessary, overnight polysomnography for the diagnosis of obstructive sleep
15769703|NCT04698122|Other|Biological sample collection|Collection of faeces, urine, saliva, and blood for biobanking, to evaluate the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile, and to perform routine screening
15769704|NCT04698122|Other|Questionnaire|Anamnestic questionnaire, 3-day food questionnaire, Food Frequency Questionnaire
15769705|NCT04698122|Other|Medical examination|Blood pressure measurement, abdominal and thoracic physical examination
15769706|NCT04698109|Other|Biological sample collection|Collection of faeces, urine, saliva, vaginal swab for biobanking, to evaluate the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile, and to perform routine screening
15769707|NCT04698109|Other|Questionnaire|Anamnestic questionnaire, 3-day food questionnaire, Food Frequency Questionnaire
15769708|NCT04698109|Other|Medical examination|Blood pressure measurement, abdominal and thoracic physical examination
15769709|NCT04698096|Other|Biological sample collection|Collection of faeces, urine, saliva, and blood for biobanking, to evaluate the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile, and to perform routine screening
15769712|NCT04698083|Diagnostic Test|Electrocardiography ,Tomographic imaging|Based on electrocardiographic follow-up analyses,the two main groups were compared in terms of rotation condition (i.e., Cwr, normal transition, or CCwr), electrocardiographic intervals, and laboratory findings In our study,CO-RADS5 was considered an advanced tomographic finding(e.g., multifocal ground glass opacities with consolidation, vascular thickening,crazy paving pattern,mixed pattern),while CO-RADS1,2,3, and 4 were considered non-advanced tomographic findings.
15769713|NCT04698070|Dietary Supplement|Nutritional Strategy - OptiMA|"All children randomized to this arm will be treated with a RUTF, with weekly ration determined according to MUAC, weight and presence of nutritional edema. Ration will be adjusted weekly according to the change in MUAC and weight throughout the outpatient follow-up until the child achieves nutritional recovery.
~RUTF dosage will 170 kcal/kg/d for the most severely wasted (MUAC < 115 mm or edema) and reduced to 125 kcal/kg/d for children with MUAC 115-119mm and 75 kcal/kg/d for children with MUAC 120-124 mm.
~All children will be followed-up for 6 months following randomization. They will have weekly outpatient visit in the health facility until they meet nutritional recovery criteria, and then a monthly community-based follow-up in their villages (vital status, anthropometric measures and clinical condition). Referral to the health facility for appropriate nutritional/medical care if illness or acute malnutrition relapse detected)."
15769714|NCT04698070|Dietary Supplement|Nutritional Strategy - ComPAS|All children randomized to this arm will be treated with RUTF, with weekly ration determined according to MUAC and presence of nutritional edema. Children enrolled with MUAC < 115 mm or edema will receive 1000 kcal/d (2 sachets/day) RUTF until MUAC has surpassed 115 mm and/or edema is resolved for 2 weeks at which time ration will be reduced to 500 kcal/d (1 sachet/day) until MUAC > or = to 125 mm is achieved for 2 consecutive weeks. Children enrolled with MUAC 115-124 mm will receive 1 sachet/day until MUAC > or = 125 mm is achieved for 2 consecutive weeks and clinically well. Following nutritional recovery, a study nurse will conduct monthly community-based follow-up in their villages (vital status, anthropometric measures and clinical condition) with referral to the health facility for appropriate nutritional/medical care if illness or acute malnutrition relapse detected) for the remainder of the 6 month period following inclusion.
15769715|NCT04698070|Other|National nutritional Strategy (Niger)|"Different protocols for SAM and MAM comprise the Niger National Nutrition Protocol:
~SAM: Children with MUAC<115 or WHZ<-3 or nutritional edema, will be treated with RUTF, according to a dosage table based on weight at each visit.
~MAM: Children aged between 6-24 months with MUAC between 115 -124 mm and WHZ>-3 will be treated with RUSF. Children with the same anthropometry but age 24-59 m will only receive supplementation if they develop criteria for SAM during the 6 month study period. They will be monitored via monthly home visits by a study nurse.
~All children will be followed-up for 6 months following randomization. Children eligible for RUTF at randomization will have a weekly outpatient visit in the health facility until they meet discharge criteria, and then a bi-monthly community-based follow-up in their villages (vital & anthropometric status and referral to the health facility for appropriate nutritional/medical care if indicated)."
15769716|NCT04698057|Drug|Placebo|The aim of the study is to validate the desescalation of the treatment to stop ciprofloxacin prescription that may not impact the outcome of the patients but add toxicity and antibiotics selection. Placebo will be administred in the experimental arm
15769717|NCT04698057|Drug|Amoxicillin Clavulanate|Will be administred to all patients
15769718|NCT04698057|Drug|Ciprofloxacin|Will be administred to patients in the standard of care arm
15769719|NCT04698044|Diagnostic Test|Hospital Anxiety Depression Scale|HADS is a self-report questionnaire designed to screen the symptoms of anxiety and depression in individuals with medical diseases other than psychiatric illnessesHADS is a self-report questionnaire designed to screen the symptoms of anxiety and depression in individuals with medical diseases other than psychiatric illnesses The 4-point Likert type scale, which consists of 14 items, has 2 subscales. Each of the HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D) subscales has 7 items. The score given for each question varies between 0 and 3. A high score indicates a high level of anxiety and depression. The responses given to the questions are given certain scores, and as a result, a score of 0-7 refers to a normal level, 8-10 to a level at the limit and 11 and above to a high level (abnormal level).
15769720|NCT04698031|Drug|Clopidogrel treatment|After randomization, patients will receive clopidogrel 75 mg daily for the duration of the study. The VA Research Pharmacy will dispense similar looking medication with Arm 2 to ensure the double-blind nature of the intervention. Clopidogrel is FDA approved for secondary prevention of stroke. Follow-up will be for 24 months with repeat brain MRI obtained at 24 months to assess for interval presence of silent brain infarctions.
15769721|NCT04698031|Drug|Aspirin treatment|After randomization, patients will receive Aspirin 325 mg daily for the duration of the study. The VA Research Pharmacy will dispense similar looking medication with Arm 2 to ensure the double-blind nature of the intervention. Aspirin is FDA approved for secondary prevention of stroke. Follow-up will be for 24 months with repeat brain MRI obtained at 24 months to assess for interval presence of silent brain infarctions.
15769722|NCT04698018|Drug|Faster Aspart|Administered s.c. (subcutaneously, under the skin) of the lower abdomen using a pen-injector.
15769723|NCT04698018|Drug|Novo Rapid|Administered s.c. (subcutaneously, under the skin) of the lower abdomen using a pen-injector.
15769724|NCT04698005|Dietary Supplement|25g Ketone monoester without added salts|oral supplementation of ketone monoester
15769725|NCT04698005|Other|Placebo|The patients will receive a placebo drink (drinking water) of equivalent volume (3x 65ml)
15769726|NCT04697992|Drug|vitamin c 20%|one eye was treated with vitamin c 20% + microneedling a session was done every 2 weeks a total of 4 sessions (other eye was placebo treated with saline + microneedling).
15769727|NCT04697992|Drug|Tranexamic acid 5mg/ml|one eye was treated with tranexamin acid 5 mg/ml + microneedling a session was done every 2 weeks a total of 4 sessions (other eye was placebo treated with saline + microneedling)
15769728|NCT04697979|Other|Questionnaire|"Selection of patients for a discharge interview in the stroke unit with collection of non-opposition and scheduling of telephone interviews or by teleconsultations at one week and then at two months after hospitalization.
~Data collection through interviews using a telephone questionnaire (or by teleconsultation) one week and then at two months after discharge. Elements on knowledge of treatment, dietary measures and warning signs and recurrence of stroke will be collected and re-explained if necessary."
15769818|NCT04697381|Biological|somatropin - adult cohort|somatropin 0.084 mg/kg/week
15770674|NCT04690075|Dietary Supplement|Nutrition Management|Routine nutrition management for 12 weeks.
15769729|NCT04697966|Behavioral|Mindfulness (Headspace) App|"The Headspace app consists of guided mindfulness meditations and is available for both Apple iOS and Android devices. For the proposed study, participants will be instructed to complete the app's most popular introductory program which consists of three levels (Basics 1-3), with each level comprising 10 sessions (30 in total) over 30 days. The program is intended to introduce the key principles and techniques of mindfulness (including focused meditation on the breath, body scanning, and noting), and strategies for applying mindfulness to daily life. Sessions begin with a duration of 10 mins, though users have the option to increase the duration to 15- and 20-mins during levels 2 and 3, respectively. (The length of these guided meditation sessions could be considered relatively brief, but they will not be modified as the purpose of this study is to examine this highly popular mindfulness app as is.) The guided meditations are supplemented with psychoeducational content."
15769730|NCT04697966|Behavioral|Psychoeducational Active Control Condition|The majority of prior research on mindfulness interventions has relied on single-arm designs or wait-list controls conditions, rather than active control conditions. Accordingly, we will include a structurally-equivalent active control condition, delivered via the same Headspace app. Specifically, the control condition will consist of 30 excerpts from Andy Puddicombe's audiobook The Headspace Guide to Meditation and Mindfulness. The narrated sessions are 10 mins in duration and delivered via the Headspace app, thus closely matching the mindfulness intervention across key attributes. User flow through the app is identical in both the mindfulness and control conditions, differing only in session content. The audiobook sessions, being predominantly psychoeducational, introduce the background and key concepts and principles behind mindfulness, and include reflections from Mr. Puddicombe's experience as a monk. The chosen excerpts exclude content which feature guided mindfulness exercises.
15769731|NCT04697953|Drug|brolucizumab|Pre-filled Syringes for intravitreal injection
15769732|NCT04697940|Biological|Decitabine-primed Tandem CAR19/20 engineered T cells|Tandem dual Specificity targeting CD19 and CD20 decitabine-primed CAR-T cells can recognize and kill the CD19 negative malignant cells through recognition of CD20 and improve the possibility of killing lymphoma tumor cells.
15769733|NCT04697927|Other|Questionnaires|The epidemiologic questionnaires used in this study are a composite of validated questions from multiple sources. Many of the questions are an expansion of the MSK General Medical Health clinical questionnaire. Validated questions capturing demographics, employment, lifestyle risk factors, family history, as well as, specific research domains including psychosocial, food security, and financial toxicity have already been utilized in other MSK minimal risk studies. The COVID-19 symptom and history tracker questions were largely drawn from the COronavirus Pandemic Epidemiology (COPE) consortium study.
15769734|NCT04697914|Diagnostic Test|Plantar pressures will be measured in 7 zones using the Footscan® platform following the two-step method. Three plantar pressures measurements were made for each foot.|to protect the metatarsus and prevent the appearance of foot pain.
15769735|NCT04697901|Device|Active Transcranial Direct Current Stimulation (tDCS)|"Active simulation will be applied to the right PPC. To target this region for stimulation, the anode electrode will be placed on the subject using the 10-20 EEG system as reference location (Thair et al., 2017). Stimulation intensity for all conditions will be set to 2 mA, which was chosen based on previous studies that have compared 1 mA to 2 mA and found the higher intensity produced reliable changes to performance (e.g., Moos et al., 2012). Total time of active stimulation will be the same for each group (20 minutes). Delivery times of the stimulation will vary based on Group assignment:
~Group A: During pre-flight brief/checklist, for 20 minutes. Group B: First delivered at 30 minutes into flight for 10 minutes, second delivered at 60 minutes into flight for 10 minutes."
15769736|NCT04697901|Device|Sham Transcranial Direct Current Stimulation (tDCS)|"Sham simulation will be applied to the right PPC. To target this region for stimulation, the anode electrode will be placed on the subject using the 10-20 EEG system as reference location (Thair et al., 2017). Stimulation intensity for all conditions will be set to 2 mA, which was chosen based on previous studies that have compared 1 mA to 2 mA and found the higher intensity produced reliable changes to performance (e.g., Moos et al., 2012). Total time of active stimulation will be the same for each group (20 minutes). Sham stimulation will consist of active stimulation for 120s, including the ramping up to 2 mA and down to no stimulation. Delivery times of the stimulation will vary based on Group assignment:
~Group A: During pre-flight brief/checklist, for 20 minutes. Group B: First delivered at 30 minutes into flight for 10 minutes, second delivered at 60 minutes into flight for 10 minutes."
15769737|NCT04697888|Drug|Omegaven|Expanded Access Therapy with Omegaven will be initiated at a starting dose of 0.5 gm/kg/day to be infused over 24 hrs. After two days of infusion the dose will be increased to 1gm/kg/day.
15769738|NCT04697875|Other|Normobaric hypoxia (FiO2 15%)|"Inhalation of deoxygenated air through an altitude simulator (Altitrainer), for approx. 1/2 hour given by a facemask, first at rest and then during exercise."
15769739|NCT04697875|Other|Placebo-ambient air (FiO2 21%)|"Inhalation of room air through an altitude simulator (Altitrainer), for approx. 1/2 hour given by a facemask, first at rest and then during exercise."
15769740|NCT04697862|Other|Normobaric hypoxia (FiO2 15%) under Sildenafil|"Inhalation of deoxygenated air through an altitude simulator (Altitrainer), for approx. 1/2 hour. given by a facemask, first at rest and then during exercise under Sildenafil."
15769741|NCT04697862|Other|Normobaric hypoxia (FiO2 15%)|"Inhalation of deoxygenated air through an altitude simulator (Altitrainer), for approx. 1/2 hour given by a facemask, first at rest and then during exercise."
15769742|NCT04697849|Behavioral|Cognitive Rehabilitation and Exposure/Sorting Therapy|Cognitive Rehabilitation and Exposure/Sorting Therapy (CREST) provides training in compensatory cognitive strategies to address the executive dysfunction typical of individuals with HD, then helps reduce the distress associated with discarding items via exposure therapy.
15769743|NCT04697849|Behavioral|Case Management|Case Management (CM). CM is the most widely available and utilized intervention for HD and is considered standard of care. This form of treatment involves managing the functional, housing, and legal ramifications of HD. Additionally, CM often involves assistance with economic, health, and social resources while providing support for the client.
15769847|NCT04697134|Behavioral|Conscious Discipline-Based Environmental Enrichment Intervention|Conscious Discipline, a social-emotional skills-based learning program that draws on current brain research and fosters enhanced connections between parents and their children.
15769939|NCT04696354|Diagnostic Test|IVUS|Those who are randomized to the interrogation arm will have diagnostic imaging performed by IVUS to determine their treatment plan.
15769744|NCT04697836|Procedure|ST|"After a computer-generated randomization list with a 1:1 intergroup ratio, ensuring equal distribution in the two groups, 30 opaque sealed envelopes numbered 1-30 were prepared. The patients were randomly divided into the Group with bilateral CPB with 15 ml 0.5% bupivacaine or the patients with translaryngeal block with 5 ml 2% lidocaine in addition to bilateral CPB.
~Following inclusion, two research assistants, with no further involvement in the study, prepared 15mL syringes and 5 ml syringes according to the envelope's specifications. The syringes were marked with the patient's randomization number. All other investigators, staff, and patients were blinded to group allocations. Before surgery, the patients were transferred to the specified block room area monitored with 3-lead electrocardiography, pulse oximetry, and non-invasive blood pressure. All patients had two intravenous cannula lines, and then bilateral CPB block procedures were performed in awake non-sedated patients."
15769745|NCT04697823|Other|use of hyaluronan-enriched transfer medium|In the study group, an embryo transfer will be performed in hyaluronan-enriched transfer medium
15769746|NCT04697810|Drug|Namodenoson|25 mg q12hours x 36 weeks
15769747|NCT04697810|Drug|Placebo|Matching capsules q12hours x 36 weeks
15769748|NCT04697797|Other|Device Programming|Intervention includes (1) pacemaker reprogramming (2) echocardiographic parameters aquisition (3) ECG recording
15769749|NCT04697784|Device|TREO Abdominal Stent-Graft System|The TREO Abdominal Stent-Graft System is intended for the treatment of infrarenal abdominal aortic aneurysms with or without iliac involvement.
15769750|NCT04697771|Other|Fine Motor Skills Training|Fine Motor Skills Training The sessions will be held by considering the fine motor skills training and the criteria of fidelity of the fine motor interventions suggested by Pfeiffer et al. Each goal was enriched with activities and games that improve fine motor skills and handwriting performance.
15769751|NCT04697758|Drug|AXT107 0.1 mg|Single intravitreal injection of AXT107 0.1 mg/eye
15769752|NCT04697758|Drug|AXT107 0.25 mg|Single intravitreal injection of AXT107 0.25 mg/eye
15769753|NCT04697758|Drug|AXT107 0.5 mg|Single intravitreal injection of AXT107 0.5 mg/eye
15769754|NCT04697745|Drug|Intrathecal dexamethasone|intrathecal adjuvants to bupivacaine
15769755|NCT04697745|Drug|Intrathecal dexmedetomidine|intrathecal adjuvants to bupivacaine
15769756|NCT04697732|Other|General anesthesia|Following emergence from general anesthesia, patients will be evaluated at 4 different timepoints; (a) One hour after emergence, (b) Twenty four hour after emergence (c) One week after emergence (d) One month after emergence. The first interview will be made face-to-face in the recovery unit, and other interviews will be made by phone.
15769757|NCT04697719|Drug|Aspirin 81mg|81mg oral capsule
15769758|NCT04697719|Drug|Aspirin 325mg|325mg oral capsule
15769759|NCT04697706|Dietary Supplement|Moonstone|"Participants will take one packet of Moonstone powder reconstituted in 500 ml water, twice a day, to total 1 L per day (66 meq of potential alkali/day) plus ad lib fluids. Moonstone packets will be supplied by Dr. Arnie's, Inc.
~Participants will follow their own self-chosen ad lib diets and complete a diet diary (Appendix) for days 6 and 7 in the first study period. On day 7, a 24-hour urine collection will be performed, and a 50-ml aliquot of urine will be sent to Litholink (Chicago, IL) via FedEx for analysis. Participants will then continue to the second study period and will use the diet diary completed in the first study period on days 6 and 7 to reproduce the identical diets for days 6 and 7 of the subsequent collection period."
15769760|NCT04697706|Other|Water|"Participants will take in 1L of tap water per day plus ad lib, self-selected fluids.
~Participants will follow their own self-chosen ad lib diets and complete a diet diary (Appendix) for days 6 and 7 in the first study period. On day 7, a 24-hour urine collection will be performed, and a 50-ml aliquot of urine will be sent to Litholink (Chicago, IL) via FedEx for analysis. Participants will then continue to the second study period and will use the diet diary completed in the first study period on days 6 and 7 to reproduce the identical diets for days 6 and 7 of the subsequent collection period."
15769761|NCT04697693|Drug|Escitalopram|he participant will be begun on either escitalopram 10mg or duloxetine 30mg. Subjects will begin escitalopram 10mg, continue this dosage for 4 weeks, then if the HRSD >7 at Week 4, he/she will have their dosage increased to 20mg for the remainder of the 8 week study.
15769762|NCT04697693|Drug|Duloxetine|Participants who have not responded to or not tolerated escitalopram in the current depressive episode will be started on duloxetine. They will take 30mg for the first 4 weeks, then be increased to 60mg for the remaining 4 weeks of the study.
15769763|NCT04697680|Behavioral|Algorithm 1|A sleep extension algorithm (algorithm 1) will be calculated and implemented based on information obtained from Sleep Diary and Fitbit data.
15769764|NCT04697680|Behavioral|Algorithm 2|A sleep extension algorithm (algorithm 2) will be calculated and implemented based on information obtained from Sleep Diary and Fitbit data.
15769765|NCT04697680|Behavioral|Algorithm 3|A sleep extension algorithm (algorithm 3) will be calculated and implemented based on information obtained from Sleep Diary and Fitbit data.
15769766|NCT04697667|Other|Exercise|Supervised exercise program
15769767|NCT04697667|Biological|PRP|Intra-articular PRP injections to knee joint
15769768|NCT04697654|Drug|TLC19|Hydroxychloroquine Liposome Inhalation Suspension
15769769|NCT04697654|Drug|TLC19 Vehicle|Liposome Inhalation Suspension (same formulation as TLC19 but without the active ingredient, HCQ)
15769770|NCT04697641|Drug|Clarithromycin 500mg|Clarithromycin 500 mg twice a day for two weeks
15769771|NCT04697641|Drug|Amoxicillin 1000 MG|Amoxicillin 1000mg twice a day for two weeks
15769772|NCT04697641|Drug|Pantoprazole 40mg|Pantoprazole 40 mg or equivalent for eight weeks
15769773|NCT04697641|Drug|Levosulpiride|Levosulpiride 25 mg as and when required before meals
15769774|NCT04697641|Drug|Acotiamide|Acotiamide 100mg as when required before meals
15769775|NCT04697641|Drug|Itopride|Itopride 50mg as when required before meals
15770675|NCT04690062|Drug|Brolucizumab-Dbll|intravitreal injection of Brolucizumab (BEOVU)
15769782|NCT04697615|Device|Algometry|The evaluation with the algometer was carried out in the same way by the two examiners, who held the instrument with the dominant hand, in order to adjust and coordinate the movements, while the non-dominant hand was used to stabilize the participant's skin, providing more security, avoiding thus small deviations. The pressure was applied at an angle of 90 ° (between the tool surface and the evaluated point), the rate of pressure increase was approximately 2 kg / cm² / s (kilogram per centimeter squared per second), up to the level that the participant reported a change in the sensation of pressure to a sensation of discomfort and immediately the examiner removed the device from the positioned location.
15769783|NCT04697602|Drug|Stepwise dose titration of febuxostat and low-dose colchicine|Febuxostat 10 mg, orally, once daily, in week 1-4 Febuxostat 20 mg, orally, once daily, in week 5-8 Febuxostat 40 mg, orally, once daily, in week 9-12 Concomitant colchicine 0.5 mg, orally, once daily in week 1-12
15769784|NCT04697602|Drug|Fixed dose febuxostat and low-dose colchicine|Febuxostat 40 mg, orally, once daily, in week 1-12 Concomitant colchicine 0.5 mg, orally, once daily in week 1-12
15769785|NCT04697589|Dietary Supplement|Memophenol 300 mg|300 mg a proprietary, standardized botanical blend rich in polyphenols (SBRP) and especially in monomers of flavanols.
15769786|NCT04697589|Dietary Supplement|Memophenol 600 mg|600 mg a proprietary, standardized botanical blend rich in polyphenols (SBRP) and especially in monomers of flavanols.
15769787|NCT04697589|Dietary Supplement|Placebo|Colored maltodextrin
15769788|NCT04697576|Biological|Ipilimumab|immune checkpoint inhibitor
15769789|NCT04697576|Biological|Nivolumab|immune checkpoint inhibitor
15769790|NCT04697576|Biological|Pembrolizumab|immune checkpoint inhibitor
15769791|NCT04697576|Biological|Quadrivalent Inactivated Influenza Vaccine|Given IM and intratumorally
15769792|NCT04697576|Procedure|Resection|Undergo surgical resection
15769793|NCT04697563|Device|Laser|real laser beam administered
15769794|NCT04697563|Device|Placebolaser|no laser beam admitted
15769795|NCT04697550|Other|Fecal microbiome transplant|fecal bacteriotherapy is the process of transferring stool from a healthy donor to another.
15769796|NCT04697550|Other|placebo|consist of a combination of agarose in normal saline/glycerol (the same vehicle as in a FMT capsules)
15769797|NCT04697537|Drug|Ultrasound guided regional anesthesia|Applied perineurally preoperatively ultrasound guided regional anesthesia
15769798|NCT04697537|Drug|Local infiltration analgesia|Applied in the wound intraoperatively from the orthopedics
15769799|NCT04697524|Behavioral|Support Group Therapy|Virtual group meetings
15769800|NCT04697524|Behavioral|Symptom Management Service (SMS) Consultation|Virtual individual meetings with symptom management service (SMS) over 5 minutes
15769801|NCT04697524|Other|Quality of Life (QOL) Questionnaires|Administered at each study visit
15769802|NCT04697524|Other|Interview|Virtual exit interview at end of study
15769803|NCT04697511|Drug|Midazolam|Participants will receive single oral dose of midazolam on Days 1, 3 and 13 under fed conditions.
15769804|NCT04697511|Drug|M2951|Participants will receive multiple oral doses (twice daily) of M2951 on Day 3 to Day 13 under fed conditions.
15769805|NCT04697498|Procedure|Bilateral bi-level Erector spine plane block|After intubation of the trachea and rotation on the abdomen before the skin incision will be performed bilateral bi-level Erector spine plane block. Before surgery, the level of screw placement will be discussed with the surgeon, and the blockade will be performed at two levels of the spine bilaterally as close as possible to the screw placement site. For blockade a solution for prolonged blockade of peripheral nerve plexuses with bupivacaine 0.375%, dexamethasone 0.02% and epinephrine 0.00018% will be used.
15769806|NCT04697498|Procedure|General anaesthesia|The control group - will include patients who will undergo surgery under general anaesthesia
15769807|NCT04697485|Drug|Bumetanide 0.5 mg, dapaglifozin 5 mg, eplerenone 25 mg|"Low-Dose, Triple Polydiuretic Therapy (LDTPT) Treatment consists of:
~Loop diuretic (bumetanide 0.5 mg)
~Mineralocorticoid receptor antagonist (eplerenone 25 mg)
~Sodium-glucose co-transporter 2 inhibitor (SGLT2i): Farxiga® (dapagliflozin) 5 mg"
15769809|NCT04697459|Other|chronic phase|1h of intradialytic execise, starting 30 min after hemodialysis beginning : 30 min of low-intensity (Borg Scale 11-14) aerobic exercise + 30 min of resistance training, frequency : 3 times a week for 16 weeks.
15769810|NCT04697459|Other|acute phase|30 min of low-intensity (Borg Scale 11-14) aerobic exercise, starting 30 min after hemodialysis beginning
15769811|NCT04697433|Device|Myotonometry|The examiner should exert a slight pressure on the determined point to the necessary depth, which will be indicated by changing the color from red to green light on the device. The device has an automatically controlled preload (0.18 Newton (N)) that will be applied to the contact area by an automatic mechanical pulse, with a duration of 15 milliseconds (ms) and a constant force of 0.4 N , these oscillations will be registered by an accelerometer next to the measurement mechanism inside the device. For each evaluation, a series of 10 consecutive pulses (multiscan mode) will be used with an interval of one second between each pulse. In each shot, the tone, stiffness, elasticity, relaxation time and creep will be calculated.
15769812|NCT04697420|Procedure|Thoracic paravertebral block|Thoracic paravertebral block is a technique in which , the local anesthetic agent is injected in the paravertebral space to anesthetise the spinal nerves after emerging from the vertebral canal in order to provide analgesia in the thoracic and upper abdominal area .
15769813|NCT04697420|Procedure|Transversus abdominis plane block|Transversus abdominis plane block is a technique is mostly done under ultrasound guidance to identify the transversus plane between the internal oblique muscle and the transverses abdominis muscle , the space in which the neurovascular supply of the anterior abdominal wall is present , and hence the injection of local anesthetic agent in this space results in anesthesia of the anterolateral aspect of the abdominal wall.
15769814|NCT04697407|Biological|Blood sampling|In all groups, 80 ml of blood will be collected. For patients, this will be done during routine cares.
15769815|NCT04697407|Biological|CSF sampling|Only in both patients groups whom will have a CSF sampling in routine care, some CSF will be collected for the study in addition, with a limit of 5 ml for routine care and study.
15769816|NCT04697381|Biological|somatropin - GH naïve pediatric cohort|somatropin 0.245 mg/kg/week
15769817|NCT04697381|Biological|somatropin - GH treated cohort|somatropin 0.084 mg/kg/week
15769819|NCT04697368|Device|Exoskeleton-Assisted Upper Limb Rehabilitation|"The patients will be undergone 25+/-3 Armeo-P training sessions, each lasting 40 minutes (i.e. five times a week for five consecutive weeks). During the first session, the device should be adjusted to the patient's arm size and the angle of suspension. The working space and the exercises will be selected once the UL has been fitted with the system. The selection of personalized exercises will be based on the motor skills of each patient and the difficulty can be gradually increased during training. In particular, a course of exercises has been defined in which the difficulty (suspension rate; the level of assistance; the complexity of movement (1D, 2D, 3D)).
~The physiotherapist will choose the modality based on the patient's motor skills (standardized personalized training)."
15769820|NCT04697368|Other|Traditional Upper Limb Rehabilitation|The control group (CG), in addition to the conventional treatment based on the routine rehabilitation program, will follow 25+/-3 sessions of traditional upper limb rehabilitation (i.e. five times a week for five consecutive weeks). Each session will consist of passive, active-assisted, and active exercises addressed for shoulder, arm and hand motor rehabilitation.
15769821|NCT04697355|Dietary Supplement|naringenin and beta carotene|Subject will ingest 300 mg naringenin three times/day and 6 mg beta carotene two times/day for eight weeks
15769822|NCT04697342|Behavioral|strategy of education|"one of the strategies is microvideo with nursing information system(NIS); another of the strategies is workshop with NIS.
~NIS of PI education is the routine education"
15769823|NCT04697329|Drug|Preincisional infiltration with levobupivacaine|Local, preincisional infiltration of port sites with levobupivacaine 5 mg/ml 20 ml
15769824|NCT04697316|Device|Transcranial Direct Current Stimulation|To stimulate the left DLPFC, the anode electrode will be placed over F3 and the cathode will be placed over F4. Each stimulation will be applied for 20 min at 2mA intensity.
15769825|NCT04697316|Device|Sham|For the sham treatment, stimulation will be stopped after 30 seconds. Current will be renewed five times throughout the session for 2 seconds each time, to mimic the tDCS stimulation.
15769826|NCT04697303|Other|anorectal function test|anorectal function test
15769827|NCT04697290|Biological|CD19/CD20 Dual-CAR-T cells|CD19/CD20 Dual-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest at least for 2 days before infusion. CD19/CD20 Dual-CAR-T cells will be intravenously infused with a escalated dose of 2E6、6E6、1E7、3E7 cells/kg.
15769828|NCT04697277|Drug|Antibiotic prophylaxis timing (before skin incision and after cord clamping) for caesarean section|
15769829|NCT04697264|Diagnostic Test|Blood and tissue sample collection from patients with endometrial cancer|Blood and tissue sample collection from patients undergoing surgery for endometrial cancer and blood sample collection only from patients undergoing chemotherapy for endometrial cancer
15769830|NCT04697251|Diagnostic Test|FOT measurements in newborns and small infants|Measurements will be performed using the device TremoFlo N-100, at bedside, with the infant in the supine position during quiet natural sleep. After proper cleaning and decontamination, the face mask of the device will be preheated at 37oC (to avoid awakening) and will be placed on infant's face. The duration of each measurement will be predetermined at 10 s. At least 3 technically acceptable measurements will be performed per infant, with 30 s intervals between them. The validity of each measurement will be assessed according to the coherence function (automatically determined by the operating system of the device).
15769831|NCT04697238|Device|Weight vest|A vest weighing up to a maximum of 15 kg.
15769832|NCT04697225|Behavioral|weight loss strategies|Participants will receive recommendations on how to increase physical activity, decrease caloric intake, monitor their weight, and track the related behaviors and progress.
15769833|NCT04697225|Behavioral|weight loss coaching sessions and email support|Participants will receive weekly coaching sessions and tailored support emails.
15769836|NCT04697199|Drug|Lactobacillus Reuteri Oral Drops|Subgingival delivery of probiotic suspension
15769837|NCT04697199|Procedure|Scaling and root planing|Scaling and root planing using hand and ultrasonic instruments
15769838|NCT04697186|Drug|Berberine|berberine , amoxicillin and rabeprazole triple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ，rabeprazole 10 mg BID.
15769839|NCT04697186|Drug|Amoxicillin|berberine , amoxicillin and rabeprazole triple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ，rabeprazole 10 mg BID.
15769840|NCT04697186|Drug|Rabeprazole|berberine , amoxicillin and rabeprazole triple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ，rabeprazole 10 mg BID.
15769841|NCT04697186|Drug|Amoxicillin|Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ，clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID
15769842|NCT04697186|Drug|Clarithromycin|Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ，clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID
15769843|NCT04697186|Drug|Rabeprazole|Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ，clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID
15769844|NCT04697186|Drug|Bismuth|Bismuth-containing Quadruple Therapygroup: given for 14 days at a dose of amoxicillin 500 mg 2 capsules BID ，clarithromycin 500mg BID ,rabeprazole 10 mg BID and bismuth 110 mg 2 capsules BID
15769845|NCT04697173|Other|Single consent|A single consent form for possible procedures the child may undergo while in the PICU
15769846|NCT04697147|Behavioral|Conscious Discipline-Based Environmental Enrichment Intervention|Conscious Discipline, a social-emotional skills-based learning program that draws on current brain research and fosters enhanced connections between parents and their children.
15769848|NCT04697121|Dietary Supplement|Combined Bergamot phytosome and Artichoke leaf dry extract|600 mg of Bergamot Phytosome and 100 mg of Artichoke leaf standardized dry extract. Supplementation regimen was 2 daily tablets, one before lunch and one before dinner, for 8 continuous weeks.
15769849|NCT04697121|Combination Product|Placebo|Supplementation regimen was 2 daily tablets, one before lunch and one before dinner, for 8 continuous weeks.
15769850|NCT04697108|Other|Shoulder reproduction teste assisted by laser pointer|In the step (1) of Familiarization in which the SRTLP was applied through a single evaluator with the aim of knowledge and understanding of the test. After five minutes, step (2) test started. In this step, the test was applied twice, by different evaluators, with an interval of five minutes between applications (inter-rater reliability). Ten minutes after the end of the tests, step (3) retest (intra-rater reliability) was started, following the same procedures as in step 2. The order of the evaluators was randomized through a draw in Excel, the order of randomization of the steps (2) and (3) was the same in order not to influence intra-rater reliability
15769851|NCT04697095|Other|Blood samples|: The blood sample from all groups will be taken on the day of inclusion, in the ophthalmology department. The patient will be cared for by a nurse and then taken to the collection room. A 100 ml sample will be taken (10 tubes of 10 ml). Blood samples will be labeled with the patient's identification number as part of the protocol. They will be transported to the research laboratory in order to be picked up for monocyte extraction. The purification of blood monocytes will be done. In case of excess, the samples will be destroyed at the end of the study.
15769852|NCT04697082|Procedure|Open surgery|Each patient entered the operating room, and after the administration of general anaesthesia, the patient was placed in the prone position. Then, the buttocks were stretched to the lateral sides using adhesive bands to remove the disease area. The sacrococcygeal region was cleaned and disinfected with 10% povidone iodine. After covering the area around the region, the sinus tract was examined by using a thin-steel cane. The length and wealth of the cavity were noted. Then, the sinus tract was removed. The depth of the cavity was noted. Then, 50 cc of 0.9% saline solution (SS) was taken into a syringe and applied to the cavity until it filled the whole space, allowing the cavity volume to be measured accurately. The measurement was performed by subtracting the remaining saline-solution volume in the syringe from the whole syringe volume, which was 50 cc.
15769853|NCT04697082|Procedure|Minimal invasive surgery|In the operating room, after the patient was placed in the prone position, the region was removed by stretching the buttocks with adhesive bands and cleaning the area with 10% povidone iodine. The largest pit was excised, and hairs in the cavity were removed with forceps. Then, the whole cavity was curetted meticulously and irrigated with SS. After haemostasis, the cavity volume was measured
15769854|NCT04697082|Other|Platelet rich plasma administration|Platelet rich plasma (PRP) was administered by filling the whole space from the lateral side of the cavity. After the first implementation of PRP, the second one was applied at 48 hours. Until that time, the dressing was not uncovered. PRP was applied on the 3rd, 4th and 5th days postoperatively.
15769855|NCT04697069|Biological|ANB019|Humanized Monoclonal Antibody
15769856|NCT04697069|Biological|Placebo|Placebo
15769857|NCT04697056|Drug|ANB019|Humanized Monoclonal Antibody
15769858|NCT04697056|Biological|placebo|placebo
15769859|NCT04697043|Procedure|Systemic therapy followed by surgery if the disease is not progressive|Primary systemic therapy (PST) or neoadjuvant therapy is used in nonmetastatic breast cancer to treat systemic disease earlier, decrease tumor bulk ideally to a complete pathological response (pCR), and reduce the extent of surgery. The systemic therapy followed by surgery if the disease is not progressive.
15769860|NCT04697017|Other|The contribution of genetics to dental caries, oral habits and occlusal traits in children of multiple births|The contribution of genetics to dental caries, oral habits and occlusal traits in children of multiple births
15769861|NCT04697004|Device|Investigational Arm: SMR Stemless Reverse|The SMR Stemless Reverse is intended for total, primary shoulder joint replacement by reducing pain and restoring shoulder articular mobility function.
15769862|NCT04697004|Device|Control Arm: SMR Reverse Shoulder System|Conventional stemmed shoulder prostheses are commonly used in the clinical practice.
15769863|NCT04696991|Behavioral|The postpartum discharge education with PechaKucha Method.|The postpartum discharge training in which the PechaKucha method was applied via the smartphones was offered to the mothers in the experimental group whereas the mothers in the control group had solely the routine discharge training. The postpartum training was offered as per the Postpartum Care Management Guideline of the Ministry of Health of Turkey. The discharge training was offered to the experimental group by using the PechaKucha presentation technique.
15769864|NCT04696965|Other|Correct/recheck strategy|One month after recruitment and every 3 months. 1. Check the inhaler step errors of patients by research assistant; 2.Demonstrate the right way by research assistant; 3. give the inhaler check list with marks of the wrong step(s) patients made to patients and 4. confirm the patients do the right way of the previous wrong step(s).
15769865|NCT04696965|Other|Usual verbal instruction|One month after recruitment and every 3 months.1. Check the inhaler step errors of patients by research assistant; 2. Verbal instruction with a physical demonstration will be given by educational nurse in usual care.
15769866|NCT04696952|Drug|TS-142|TS-142
15769867|NCT04696952|Drug|Zopiclone|Zopiclone
15769868|NCT04696952|Drug|Placebo|Placebo
15769869|NCT04696939|Drug|Atezolizumab|Atezolizumab intravenous infusion was administered at a dose of 1200mg on Day 1 of each 21-day cycle.
15769870|NCT04696939|Drug|Carboplatin|Carboplatin intravenous infusion was administered at a dose of 75mg/m^2 on Day 1 of each 21-day cycle.
15769871|NCT04696939|Drug|Etoposide|Etoposide intravenous infusion was administered at a dose of 100 mg/m^2 on Day 1 of every 3-day cycle.
15769872|NCT04696926|Other|Edwards Intuity TM Valve implantation|aortic valve replacement with an Edwards Intuity TM bioprosthesis
15769873|NCT04696913|Diagnostic Test|Exposure: Positive COVID-19 infection|Exposure: Positive COVID-19 infection as determined by RT-PCR
15769874|NCT04696913|Diagnostic Test|Exposure: Negative COVID-19 infection|Exposure: Negative COVID-19 infection as determined by RT-PCR
15769875|NCT04696900|Procedure|Exercise training|exercise training in an approved rehabilitation program
15769937|NCT04696380|Device|JUUL e-cigarette|Participants will sample preferred vs non-preferred JUUL flavors.
15769938|NCT04696367|Procedure|Emergency laparotomy|Midline laparotomy for acute intra-abdominal pathology
15769876|NCT04696887|Behavioral|Tele Tai Chi Intervention for Persons Aging with Long-Term Mobility Disabilities|• 8-week Tele Tai Chi intervention, participants will use a tablet or computer to join a small-group, online class (1hr, twice weekly) from home; during each session, participants will exercise as a group along with the pre-recorded video lessons and have the opportunity for social interaction (via video chat) before and after class.
15769877|NCT04696861|Behavioral|IDEAS for Hope|Participants will receive three counseling sessions at two week intervals, delivered by telehealth by a trained psychiatric nurse, focused on managing suicidal ideation and enhancing HIV care engagement.
15769878|NCT04696861|Behavioral|Enhanced Standard of Care (Safety Planning)|Participants will receive a brief, 10-15 minute counseling session, delivered by telehealth by a trained psychiatric nurse, focused on safety planning.
15769879|NCT04696848|Drug|CKD-516 plus Durvalumab|"Stage 1 : dose escalation durvalumab (1500 mg Q4W) in combination with CKD-516 at 1 of 3 planned dose levels (9, 11, or 13 mg/m2 twice a week for 3 weeks in each cycle, Q4W).
~Stage 2 : durvalumab (1500 mg Q4W) in combination with CKD-516 at recommended phase 2 dose (twice a week for 3 weeks in each cycle, Q4W)."
15769880|NCT04696835|Diagnostic Test|speech audiometry|65dB, 55dB or 75dB SPL speech audiometry
15769881|NCT04696822|Drug|Epinephrine Nasal Product, 1.6 mg|Single dose Nasal powder spray without allergen challenge
15769882|NCT04696822|Drug|Epinephrine nasal product, 1.6 mg + allergen|Single dose Nasal powder spray with allergen challenge
15769883|NCT04696822|Drug|Epinephrine Injection 0.3 mg|Intramuscular injection
15769884|NCT04696822|Drug|Epinephrine Nasal Product, 3.2 mg|Twice dose Nasal powder spray without allergen challenge
15769885|NCT04696822|Drug|Epinephrine Nasal Product, 3.2 mg + allergen|Twice dose Nasal powder spray with allergen challenge
15769886|NCT04696809|Drug|Teclistamab|Teclistamab will be administered subcutaneously.
15769887|NCT04696796|Procedure|Mediolateral Episiotomy with BasIQ-4 Surgical Knife|Mediolateral episiotomy will be performed with BasIQ-4 Surgical Knife which cuts from distal to the center with inner knife.
15769888|NCT04696796|Procedure|Mediolateral Episiotomy with Episiotomy Scissors|Mediolateral episiotomy will be made from the central to the distal with episiotomy scissors
15769889|NCT04696783|Drug|Esomeprazole Magnesium Enteric-coated Tablets|Nexium taken once every 2 days plus lifestyle adjustment
15769890|NCT04696783|Behavioral|Lifestyle adjustment|Lifestyle adjustment
15769891|NCT04696770|Behavioral|Mindfulness|Mindfulness techniques will be taught to the participants
15769892|NCT04696757|Drug|Capecitabine|Capecitabine without surgery
15769893|NCT04696744|Biological|CTC detection|"The collection and analysis of CTCs will be carried out in the following 6 steps: A blood sample will be taken: a maximum volume of 30 ml on 3 x 10 ml BD Vacutainer® EDTA tubes is required for the study.
~CTCs will be enumerated and characterized by immunofluorescence after immunostaining with the following antibodies: anticytokeratin, anti-CD44, anti-N-cadherin and anti-PD-L1.
~• - Secondary criterion(s) : Different tumor and clinical parameters will be analysed to find a correlation with CTC detection Gene expression profiles will be analyzed using the RNAseq single-cell at different times: before treatment, at interim times, and in case of relapse in order to establish correlations between patients at high risk of relapse and their molecular profiles"
15769894|NCT04696731|Genetic|ALLO-316|ALLO-316 is an allogeneic CAR T cell therapy targeting CD70
15769895|NCT04696731|Biological|ALLO-647|ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
15769896|NCT04696731|Drug|Fludarabine|Chemotherapy for lymphodepletion
15769897|NCT04696731|Drug|Cyclophosphamide|Chemotherapy for lymphodepletion
15769898|NCT04696718|Dietary Supplement|daily supplementation|the patients will consume 1 pill of probiotic each day for 28 days per treatments each treatment is separated by a wash out period of 21 days
15769899|NCT04696705|Biological|Ex-vivo expanded allogeneic γδT cells|Cells will be extracted from a healthy donor by apheresis, followed by ex-vivo expansion and activation. The ex-vivo expanded γδT cells from donors will be adoptively transfused.
15769900|NCT04696692|Other|Patient with histologically confirmed diffuse large B-cell lymphoma with a planned first line treatment by R-CHOP.|"Blood samples will be collected :
~at baseline (before the 1st R-CHOP cycle)
~before the 3d administration of chemotherapy (CT) (i.e. after 2 cycles of CT and same timepoint as interim FDG-PET/CT)
~at the end of induction (i.e. end of R-CHOP treatment)
~at 24 months after initiation of R-CHOP treatment
~at the time of progression (if progression occurs before 24 months of treatment).
~Tumor samples will be collected at baseline (from an archived initial diagnostic tumor specimen) and at the time of progression (if applicable from lymph node biopsy performed as part of a standard of care surgical procedure).
~Bone marrow samples will be collected at baseline and at the time of progression (if applicable) only in patients for whom a bone marrow aspiration (BMA) is necessary as part of their standard of care, upon physician's decision."
15769901|NCT04696679|Other|Patient Quality of life assessment|Other: Patient questionnaire about quality of life assessment and their determinants during the confinement-deconfinement period of Covid-19 pandemic in France
15769902|NCT04696679|Other|Control group Quality of life assessment|Other: Patient questionnaire about quality of life assessment and their determinants during the confinement-deconfinement period of Covid-19 pandemic in France relationships with teachers, schoolwork, and self-esteem)
15769903|NCT04696666|Device|INSTYLAN (Sodium Hyaluronate 80mg/50ml)|The bladder instillation with INSTYLAN is a treatment involving a sterile solution of Sodium Hyaluronate (80mg/50ml) inserted into the bladder through a catheter and released after a short period of time.
15769904|NCT04696653|Other|Comprehensive Unit Based Safety Program (CUSP)|CUSP is a quality improvement strategy developed by the Johns Hopkins University Armstrong Institute for Patient Safety and Quality that is used to improve care delivery.
15769905|NCT04696640|Behavioral|Remote Patient Monitoring|Participants' glucose data will be monitored by the study team using population analytic reports. Participants who either have excessive hypoglycemia or hyperglycemia on these reports will be contacted by a pediatric endocrinologist (the principal investigator) to discuss any necessary adjustments to their home diabetes management plans. This intervention will be in addition to their usual care (regular visits at the UC Davis Pediatric Endocrinology clinic).
15769906|NCT04696627|Other|Questionnaire|Participants from all 3 groups will be interviewed
15769907|NCT04696614|Behavioral|exercise|intervention groups provided different sequential modality of exercise
15769908|NCT04696601|Diagnostic Test|Olfactory test|The olfactory test (Olfascan) is in the form of a paper stick, previously impregnated with an odorant (non-liquid). It is placed a few centimetres from the participant's nose at the time of the test. It is a single-use test, without contact with the participant.
15769909|NCT04696588|Other|Complex set of kinesiotherapy of cervical spine and delicate massage|"Intervention:- A complex neck therapy.Treatment comprises 10 sessions performed on consecutive working days, includes four parts.
~Active exercises of the neck, 5 minutes, first demonstrated by the physiotherapist and next the patient performs them under supervision, 5 repetitions of each of the following: cervical flexion, rotation to the left and to the right, side bending to the left and to the right, torsion to left and right.
~Massage of cervical interspinales muscles performed by therapist 3 minutes.
~Post Isometric Relaxation (PIR) performed by physiotherapist. 15 minutes.
~Active neck exercises - the same as mentioned in step 1. 5 minutes. Total duration of one treatment session is around 30 minutes."
15769910|NCT04696575|Biological|Atezolizumab|Given IV
15769911|NCT04696575|Drug|Carboplatin|Given IV
15769912|NCT04696575|Drug|Etoposide|Given IV
15769913|NCT04696575|Drug|Lamivudine|Given PO
15769914|NCT04696562|Behavioral|Deep Breathing Exercise with Triflo|The investigators will do deep breathing exercises 5-10 times an hour with the triflo device.
15769915|NCT04696549|Behavioral|Virtual visual art experience guided by Visual Thinking Strategies|All study dyads (where study dyad consists of a participant with dementia and his/her care-partner) will participate in 3 scheduled virtual visual art sessions via Zoom. Each session will last about an hour and will include a guided discussion of pre-selected visual art using the Visual Thinking Strategies approach. It is anticipated that two pieces of art will be shown during each art session. The three sessions will be scheduled one month apart.
15769916|NCT04696536|Other|Colgate Cavity Protection Toothpaste|Participants will use Colgate cavity protection toothpaste for brushing teeth twice daily.
15769917|NCT04696536|Other|American Dental Association (ADA) Referenced Toothbrush|Participants will brush teeth at least one minute with provided toothbrush twice daily.
15769918|NCT04696536|Other|5% Hydroalcohol Mouth Rinse|Participants use 20 mL of 5% Hydroalcohol mouth rinse as negative control for 30 sec twice a day after brushing.
15769919|NCT04696536|Other|REACH Dental Floss|Participants after brushing, rinse mouth with water and floss using Reach dental floss once a day.
15769920|NCT04696536|Other|Alcohol-containing Essential Oil (AEO) Mouth Rinse (Listerine Cool Mint, marketed)|Participants after brushing, rinse with 20mL of the AEO mouth rinse for 30 seconds twice a day.
15769921|NCT04696523|Drug|Xenon|Xenon arm will be treated with xenon inhalation with endtidal concentration of 50 % in air/oxygen and with standard of care
15769922|NCT04696523|Drug|air/oxygen|Control group will be treated with air/oxygen
15769923|NCT04696497|Diagnostic Test|Ultrasound|"Ultrasound measurements of muscle thickness, using a linear probe (high frequency) on four muscle groups:
~Shoulder Side muscular compartment
~Anterior Arm muscular compartment
~Anterior thigh muscular compartment
~Antero-lateral leg muscular compartment"
15769924|NCT04696497|Diagnostic Test|Dynamometric muscular assessment|"The principle of electronic dynamometry is to measure an isometric force. To carry out these measurements, the examiner will stand on the side who has to be tested by exerting a pressure diametrically opposite to the patient's movement, thus preventing him/her from carrying out the movement. The patient will perform 3 tests for each movement, the best value will be collected by the examiner.
~The reference position is :
~Patient elbowed to the body bent at 90°, with trunk inclination at 30° in the resuscitation bed, lower limbs flat."
15769925|NCT04696497|Diagnostic Test|Manual muscular Assessment (MRC-SS)|Following the same positions as for the dynamometer, the examiner will evaluate the 12 motor functions according to the following 60-point rating. With the maximum quote of 5 point representing normal strength and 0 point the total absence of any muscular contraction
15769926|NCT04696484|Behavioral|coopeRATE Prompt|The coopeRATE Prompt intervention is a set of two questions delivered to patients before the clinical encounter that elicit their concerns and goals. The intervention is delivered to patients online, outside the clinic setting.
15769929|NCT04696458|Dietary Supplement|Lactobacillus plantarum (CECT7484 and CECT7485)/ Pediococcus acidilactici (CECT7483)|Probiotic Capsules in blister packets of capsules containing the probiotic intervention contain a combination of three strains of lactic acid bacteria: two Lactobacillus plantarum (CECT7484 and CECT7485) and one Pediococcus acidilactici (CECT7483).
15769930|NCT04696458|Other|Placebo Comparator: Placebo|Placebo Capsules in blister packets of capsules containing the inert (controlled) non-interventional treatment.
15769931|NCT04696445|Drug|Morphine & Oxycodone|Morphine and Oxycodone are used in daily practice as part of standard care. Morphine and Oxycodone will be acquired through the clinical pharmacy of St Antonius and administered according to the standard postoperative pain protocol.
15769932|NCT04696432|Biological|CD19/CD20-directed CAR-T cells|Autologous 2nd generation CD19/CD20-directed CAR-T cells, single infusion intravenously
15769933|NCT04696419|Other|Different intensities of contact to dogs|Each subject is exposed to four test situations of 10 minutes. Three situations with increasing intensity of dog contact, and one control test situation with no contact to a dog. The order of the test situations is random and with 30 minute washout in-between
15769934|NCT04696406|Device|RESPINOR DXT|Blinded, continuous diaphragmatic excursion measurements by DXT will be conducted during the patients' first SBT. The recording shall be initiated 15 minutes prior to the first SBT and will end 15 minutes post SBT.
15769935|NCT04696393|Drug|Mitapivat tablet|Oral tablets
15769936|NCT04696380|Drug|Nicotine|Participants will sample high vs low nicotine.
15769940|NCT04696354|Other|Continued Compression Therapy/Stockings|Those who are randomized to the deferred interrogation arm while continue compression therapy as prescribed.
15769941|NCT04696341|Procedure|Matrix Rhythm Therapy|Hot pack to cervical and upper thoracic regions (20 min), conventional TENS (100 Hz for 40 μsec), therapeutic ultrasound (1 MHz for 5 min) and conventional massage (using stroking, kneading and friction techniques for 5 minutes) were applied as passive physiotherapy modalities. Normal range of motion exercises, posture exercises, stretching exercises and isometric exercises were instructed as part of active physiotherapy.Five sessions of MRT (2., 5., 6., 8., 10. sessions of combined physiotherapy programme) was added at combined physiotherapy to Matrix Rhythm Group. Matrix Rhythm Therapy was applied to cervical and thoracic regions using 10 Hz frequency for 30 min (15 min for right and left sides each) according to the instructions of the technique developer.
15769942|NCT04696341|Procedure|Control|Hot pack to cervical and upper thoracic regions (20 min), conventional TENS (100 Hz for 40 μsec), therapeutic ultrasound (1 MHz for 5 min) and conventional massage (using stroking, kneading and friction techniques for 5 minutes) were applied as passive physiotherapy modalities. Normal range of motion exercises, posture exercises, stretching exercises and isometric exercises were instructed as part of active physiotherapy.
15769943|NCT04696328|Biological|Human (allogeneic) iPS cell derived-cardiomyocyte sheet|Transplantation
15769944|NCT04696315|Diagnostic Test|Multiple features extraction|"In the present study, the gold standard of preclinical AD is amyloid PET. SCD with positive amyloid is the target population for early AD intervention. The investigators aim to extract the diagnostic features from multiple parameter MRI, genetic, blood and clinical data using Max-Relevance and Min-Redundancy (mRMR) algorithm. Then, based on support vector machine (SVM), random forest (RF) and multi-kernel learning (MKL) classification methods, the investigators will construct predicted diagnostic model of preclinical AD."
15769945|NCT04696302|Behavioral|Focus of attention|Individuals were asked to laterally weight shift while seated with either internal focus or external focus instructions.
15769946|NCT04696289|Diagnostic Test|Standardized catheterization assessment|"There are four components to the pulmonary vein assessment.
~Angiography: pulmonary artery wedge injection and/or selective pulmonary vein injection.
~Intravascular ultrasound: manual pullback of IVUS catheter from lobar segment to left atrium.
~Pressure assessment: pulmonary vein pressure (mmHg) measured before and after (if applicable) intervention.
~Compliance testing: the compliance of the vein will be measured using a compliant conventional balloon."
15769947|NCT04696276|Other|ERAS protocol|special approaches in three phases preoperatively, intraoperatively and postoperatively, by an interdisciplinary team comprising of the surgeon, the anesthesiologist and the nurse. The combination of these techniques reduces the reaction to postoperative stress, relieves acute postoperative pain, restores the patient immediately to their original feeding and mobilization habits, thus reducing the time required for their complete recovery.
15769948|NCT04696263|Device|Da Vinci ® Xi system - MP Robotic Radical Prostatectomy|After pneumoperitoneum is established, four 8mm, one 12 mm, and one 5 mm trocars are placed for instrumentation. After the robot is docked, radical prostatectomy is performed with the SOC approach.
15769949|NCT04696263|Device|Da Vinci ® SP system - SP Robotic Radical Prostatectomy|After induction of general anesthesia and supine participant positioning, a 3.5 cm infraumbilical incision will be made for single-port access into the space of Retzius. Radical prostatectomy is then performed with the SOC approach
15769950|NCT04696250|Drug|Antineoplastic and Immunomodulating Agents|Antineoplastic agents, endocrine therapy, immunostimulants and immunosuppressants drugs included in the ATC classification L
15769951|NCT04696237|Other|Questionnaire|a questionnaire to provide data about the management of cleft lip and palate patients in Egypt will be designed
15769952|NCT04696224|Drug|Tranexamic acid|The surgical technique consists in patient in supina position with previous reduction with lower limb traction (on a traction table or manual) associated or not with the use of percutaneous reduction clamps. Longitudinal lateral incision of 3-5 cm proximal to the greater trochanter, approximately 5 cm long, will be performed. After the skin and subcutaneous incision, the fascia lata will be incised in the same direction, with exposure of the gluteal muscles and the proximal femur. The awl will be introduced at the tip of the greater trochanter and then, at the same location, an intramedullary guidewire, towards the proximal shaft, crossing the fracture. A 3 cm incision to the thigh and inferior to the initial incision with template to introduce the screw in the center of the femoral head. Then, a 2cm incision will be made at the distal end of the nail, and a hole in the femur for the distal lock in dynamic nail hole with a 4.5mm drill where a cortical screw will be inserted.
15769953|NCT04696224|Other|Saline solution|30 patients who will not receive the TXA, but will receive a 100ml intravenous saline solution 0,9% after anesthetic induction and before incising the skin (such as group 1) and a compress soaked in saline solution as used in group 2
15769954|NCT04696211|Other|Music-with-movement exercise|A music-with-movement exercise programme to reduce chronic pain in older adults.
15769955|NCT04696198|Other|Manual Therapy Intervention|Manual Therapy Interventions to improve range of motion and decrease pain
15769956|NCT04696198|Other|Standard care|standard care
15769957|NCT04696185|Drug|Dapagliflozin 10 MG|Dapagliflozin 10 mg (daily oral dose)
15769958|NCT04696159|Procedure|Pyloromyotomy|Endoscopic Per-Oral Pyloromyotomy (POP)
15769959|NCT04696146|Drug|Berinert|Intrarenal dose of 500 U of Berinert
15769960|NCT04696146|Drug|Placebo|Normal Saline placebo
15769961|NCT04696133|Other|fine motor skills|stretching and strengthening exercises in addition to exercises to enhance fine motor skills
15769962|NCT04696133|Other|sensory integration|"Tactile stimulation
~Proprioceptive stimulation
~The fine motor skills
~Heavy work activities (i.e., proprioceptive input)"
15769963|NCT04696120|Drug|Apixaban|Patients who are randomly assigned to apixaban group will receive apixaban 5mg or 2.5mg bid
15769964|NCT04696120|Drug|Placebo|All patients who are assigned to placebo group will receive placebo
15770011|NCT04695652|Biological|MVC-COV1901(S protein with adjuvant)|Approximately 3180 participants will receive 2 doses of MVC-COV1901(S-2P protein with adjuvant) at Visit 2 (Day 1) and Visit 4 (Day 29) via intramuscular (IM) injection in the deltoid region
15770012|NCT04695652|Biological|MVC-COV1901(Saline)|Approximately 530 participants will receive 2 doses of MVC-COV1901(Saline) at Visit 2 (Day 1) and Visit 4 (Day 29) via IM injection in the deltoid region
15771459|NCT04683445|Drug|Eribulin|Eribulin，1.4mg/m2，Intravenous infusion，d1，d8，3-week cycle
15769965|NCT04696107|Behavioral|Psychoeducative intervention|"This workshop is centred in psychoeducational and training action in emotional self-regulation in a group modality and participatory character, aimed at patients with mCNCP to acquire basic knowledge in:
~Neurology and psychoneuroimmunology.
~The role of beliefs in our manifestation of the disease.
~Body language and modulation of pain perception.
~Relaxation body-mind techniques.
~Creative visualization for pain management.
~Mirror feed-back.
~The workshop will take place at the Hospital San Juan de Dios del Aljarafe, in four weeks, once a week, three hours each. Until now, the attendance was 24 patients per workshop. After the pandemic, we will reduce to 15 to increase safety distance. We will also conduct a telephone survey of each patient on symptoms of Covid infection in the 24 hours prior to the workshop."
15769966|NCT04696081|Other|occurence of atrial fibrillation|all adult patients with an active cancer and experiencing atrial fibrillation will be consecutively include. Active cancers will be defined according Agnelli et al. (NEJM 2020; 382:1599-1607).
15769967|NCT04696068|Other|Porcelain plates|The patients will receive the same food in another presentation : porcelain plates instead of plastic trays
15769970|NCT04696042|Drug|Lanreotide autogel|Lanreotide autogel 90-120 mcg, every 4 weeks
15769971|NCT04696029|Drug|Difluoromethylornithine|"DFMO (difluoromethylornithine is an inhibitor of ornithine decarboxylase (ODC) designated chemically as 2-(difluoromethyl)-DL-ornithine monohydrochloride monohydrate.
~The dosage form to be used in this study is provided as a convex tablet containing 192 mg eflornithine (equivalent to 250 mg of eflornithine HCl, monohydrate). The tablets are packaged and sealed in opaque white HDPE bottles, and each bottle contains 100 tablets. The DMFO tablets are supplied by USWorldMeds (USWM).
~The tablets are to be stored at room temperature (20-250C)."
15769972|NCT04696016|Procedure|Skin conductance guided antinociception|The value of skin conductance guides the titration of sufentanil
15769973|NCT04696016|Procedure|Standard care antinociception|The intensive care team titrates antinociception based on their standard approach (using a clinical approach by assessing blood pressure, heart rate, and ventilator dyssynchrony).
15769974|NCT04696003|Combination Product|Continuous amnioinfusion with Amnion Flush Solution through the intraamniotic catheter|The amniotic cavity will be punctured with a 18 gauge needle under ultrasound control. The intraamniotic catheter (0.65 mm Diameter, CE 0481, PakuMed GmbH, Essen, Germany) will be placed under local anesthesia with Xylocaine 1% 10 ml. and the amnioinfusion (about 100 ml/h, 2400 ml/day) with artificial amniotic fluid (Amnion Flush Solution, CE 0483, Serumwerk AG Bernburg, Germany) will be carried out with an infusion rate of 100 ml/h under periodic ultrasound using the standard i.v. pump.
15769975|NCT04695990|Drug|Wenyang Huoxue Decoction|Wenyang Huoxue granules
15769976|NCT04695990|Drug|Wenyang Huoxue placebo|Wenyang Huoxue placebo have an identical appearance and scent as the active treatment granules.
15769977|NCT04695977|Drug|CMP-001|Subjects will receive CMP-001 10 mg IT weekly for 7 doses after which CMP-001 will be administered every 3 weeks (Q3W).
15769978|NCT04695977|Drug|Nivolumab|Nivolumab 360 mg IV is administered Q3W.
15769979|NCT04695964|Diagnostic Test|ICG-NIRF Imaging plus ingress and egress analysis|intraoperative NIRF Imaging using the fluorescence agent ICG (indocyanine-green) at regions of interest before (T1) + after pouch construction (T2) + after ileoanal anastomosis (T3) Additional ingress and egress analysis (inflow and outflow analysis) of specificities regions of interest at regions of interest before (T1) + after pouch construction (T2) + after ileoanal anastomosis (T3)
15769980|NCT04695951|Dietary Supplement|Renalof|A total of 120 patients treated with the study product Renalof® at a dose of 650 mg twice daily were followed for 4 months. A preliminary analysis of the types of stones present in the study patients was performed according to the main compound, using a biophysical profile by biochemical analysis and the clinical characteristics, medical history and biochemical profile of the creatinine values of the test patients. Imaging and quality of life tests were carried out during the trial to check the efficacy and possible adverse effects of the test product in patients with kidney stones.
15769981|NCT04695951|Other|Placebo|A total of 35 patients treated with Placebo at a dose of 650 mg twice daily were followed for 4 months. A preliminary analysis of the types of stones present in the study patients was performed according to the main compound, using a biophysical profile by biochemical analysis and the clinical characteristics, medical history and biochemical profile of the creatinine values of the test patients. Imaging and quality of life tests were carried out during the trial to check the efficacy and possible adverse effects of the test product in patients with kidney stones.
15769982|NCT04695938|Diagnostic Test|MRI|MRI examination with Black Bone, and ultrashort/zero echo time MRI techniques
15769983|NCT04695925|Drug|Osimertinib 80 MG [Tagrisso]|osimertinib 80 mg po qd until disease progression
15769984|NCT04695925|Drug|Pemetrexed 500 MG Injection|pemetrexed 500 mg/m2 intravenously every 3 weeks until disease progression
15769985|NCT04695925|Drug|Carboplatin|carboplatin area under curve 5 intravenously every 3 weeks for four cycles
15769986|NCT04695912|Device|The SENS motion® sensor|"The sensor is a wearable physical tracker giving investigators feedback about daily activity
~The SENS motion® system consists of:
~The sensor 'SENS Motion Patch' A smart-phone application 'SENS motion´
~SENS motion cloud storage database, a web-based visualization of data for the healthcare team
~The iSpine app shows activity-information recorded by the sensor to the patient and gives nudges to activity."
15769987|NCT04695899|Device|Dental Implant|"See Section Procedures."
15770136|NCT04694638|Other|Body position change|combined use of prone positioning and high-flow nasal cannula (HFNC) and non-invasive positive pressure ventilation (NIPPV) can reduce the rate of intubation in acute hypoxemic and/or hypercapnic respiratory failure secondary to COVID-19 infection.
15770137|NCT04694625|Other|Structured Rehabilitation Program|Early Function Phase (Protective phase) week 1 Progressive Function Phase (Recovery Phase) 2nd and 3rd week Advance Function Phase (Activity Phase) 4th week
15770140|NCT04694612|Drug|Placebo|Comparison of clinical improvement and clinical deterioration between those receiving Favipiravir compared to placebo in the patients with mild COVID-19
15837115|NCT04147936|Dietary Supplement|AXA1665|Dietary supplement: AXA1665
15769988|NCT04695886|Other|Community-delivered Integrated Malaria Elimination (CIME) intervention model|"Malaria: Malaria Diagnosis using RDT, treatment, referral and reporting; Prevention interventions (Behavioral Change Communication, net and repellent distribution); assisting in case and foci investigation and larval source management.
~Dengue: Assisting in dengue prevention; Referral of cases. Tuberculosis (TB): Detection and referral of suspected cases; Contact tracing; Directly observed treatment, short-course (DOTS) providers; defaulter tracing; follow-up sputum examinations; assisting in TB health education talks and active case detection activities.
~Childhood diarrhea: Prevention; Health education and Water, sanitation and hygiene (WASH) promotion; Diagnosis and dehydration assessment; Treatment and referral; Rehydration therapy using Oral Rehydration Solution (ORS) and oral Zinc tablet; assisted referral.
~RDT-negative fever: Prevention and health education; Symptomatic treatment with antipyretics and immediate assisted referral."
15769989|NCT04695873|Device|Corn Foam Cushion|An anatomically shaped foam pad with a central hole. The upper layer is made from a honeycomb of interconnecting cells, the external facing surface is smooth, the underside is coated with adhesive.
15769990|NCT04695860|Drug|Burosumab|Q4w, 1mg/kg Body weight, s.c.
15769991|NCT04695847|Drug|M1231|M1231 will be administered at escalated doses every three weeks until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
15769992|NCT04695847|Drug|M1231|M1231 will be administered at the dose determined as RDE in part 1, every three weeks until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
15769993|NCT04695834|Procedure|Neurolysis peroneal nerve|The surgical approach for entrapment at the fibular head is usually through a curvilinear incision just distal to the fibular head. The subcutaneous tissue is bluntly dissected, and the common peroneal nerve is identified proximal to the peroneus longus muscle. The peroneal nerve is then released from the surrounding fibrous tissue and fascia. The nerve is decompressed distally as it dives under the peroneus longus muscle. The decompression at this site is essential. Certain authors state that an adequate decompression should extend beyond the bifurcation in the deep and superficial peroneal nerve and should involve cutting the intermuscular septa
15769994|NCT04695834|Other|Maximal physiotherapy|Mobilization of ankle and foot, stretching of the calf muscles (prevention of contractures) Tonification of the dorsiflexion- and eversion muscles of the ankle Proprioceptive training Gait rehabilitation Home exercise schedule
15769995|NCT04695821|Device|Senti V1.0 Device|"This device class I, CE marked garment, with a similar form to a T-Shirt, embedded with ten sensor modules encased in silicone; the device comes with a charging stand in the form of a clothes hanger. Depending on the outcome of this feasibility study, the device may, in the future, form part of a class IIb medical device system, when accompanied by cloud-based software to listen to both current and historically recorded breath sounds for each Senti patient. The Senti Version One device will be labelled clearly to indicate the device version, on the inside of the garment, conforming to the MDR.
~The garment itself will be made from textile composite, including cotton, elastase, micromodel, spandex, and polyester. All other components (including electronic and other plastic components) will be entirely encased in medical-grade silicone."
15769996|NCT04695808|Behavioral|yoga|Yoga practice will be done two days a week for 10 weeks.
15769997|NCT04695782|Radiation|Pencil beam proton radiotherapy|Doseescalated pencil beam proton Therapy
15769998|NCT04695769|Drug|Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi] plus Ribavirin|Patients will receive Sofosbuvir / Velpatasvir / Voxilaprevir with weight-based Ribavirin for 12 weeks.
15769999|NCT04695769|Drug|Sofosbuvir / Velpatasvir / Voxilaprevir Oral Tablet [Vosevi]|Patients will receive Sofosbuvir / Velpatasvir / Voxilaprevir for 12 weeks.
15770000|NCT04695756|Other|COVID-19 pandemic|The exposure of this observational study is the COVID-19 pandemic
15770001|NCT04695743|Other|Online Cognitive Stimulation Therapy|Participants will attend 14 x 1 hour online CST sessions that involve a variety of activities to stimulate the brain and focus on cognitive strengths based on a variety of themes i.e. childhood, using money, etc. This will aim to be multisensory and give choice and empowerment to participants. Benefits of face to face CST are shown to slow cognitive decline and improve quality of life. Adapting it for online use will investigate whether participants can still benefit in this way.
15770002|NCT04695730|Other|Active physical therapy (including both pain education and home exercises)|"One session (60 minutes). In this session, a physical therapist will explain and demonstrate the exercises to perform individually at home. Exercises will be performed daily. In addition, an education session will be provided, concerning pain mechanisms and management. To support patients during the treatment, a booklet will be created.
~One booster session (30minutes) will be planned after 4 weeks. Patients will follow the active treatment for 8 weeks."
15770003|NCT04695730|Other|Active physical therapy plus manual therapy|"Participants in the Group 2 will receive active intervention plus 8 Pompage technique sessions (1 session/week). In these sessions (30 minutes each), Pompage technique will be performed by a physical therapist."
15770004|NCT04695717|Biological|IVACFLU-S|"The Seasonal Inactivated, Split Virion, Trivalent Influenza Vaccine (TIV) were purified by the method of super centrifugation to create gradient segments in sucrose sugar produced by IVAC, or placebo produced by IVAC. Vaccines are produced on eggs, inactivated with formaldehyde. The dose of the vaccine tested was 15 mcg of HA for each antigen component in 0.5 ml.
~The influenza virus strains used to produce the 2020-2021 seasonal vaccine will also be provided by the NIBSC, which will be used according to WHO's recommendation, which is expected to include the following Southern Hemisphere strains:
~Influenza A / H1N1 strain: Recombinant strain IVR-190 44250 E12 of the strain (A / Brisbane / 02/2018).
~Influenza strain A / H3N2: strain IVR-197 (H3N2) 44850 E14 recombinant strain (A / South Australia / 34/2019).
~Flu strain B (B / Washington / February 2019)."
15770005|NCT04695704|Drug|Montelukast|10 mg oral montelukast once daily for 28 days
15770006|NCT04695704|Other|placebo|10 mg oral placebo once daily for 28 days
15770007|NCT04695678|Diagnostic Test|COVID-19 nasal/pharyngeal swab|each study participant receives a nasal/pharyngeal swab
15770008|NCT04695665|Other|Cervical pain|Exercise program for cervical spine according to McGill's approach.
15770009|NCT04695665|Other|Thoracic pain|Exercise program for thoracic spine according to McGill's approach.
15770010|NCT04695665|Other|Lumbar pain|Exercise program for lumbar spine according to McGill's approach.
15770177|NCT04694300|Drug|Naproxen|"440 mg by mouth immediately after completion of implant surgery followed by 220 mg 12 hours later.
~Then 220 mg every 8 hours for the next two days."
15770013|NCT04695639|Other|Test of Arm Selective Control|It will be used to assess selective voluntary motor control. It is a reliable and valid evaluation tool used to quantify and describe selective voluntary motor control in children with spastic cerebral palsy. The goal of the assessment is to systematically evaluate a person's ability to move the upper extremity with selective voluntary motor control by observing movement control, coordination, fluency, mirroring, and speed at each joint, and then assigning a grade, all in 'real time. Clinically this measure may guide the selection of medical, surgical, or therapy interventions and may improve outcome prognosis after brief training. Raters demonstrated excellent reliability in assessing upper extremity SVMC in a group of children with hemiplegic, diplegic, and quadriplegic CP using the Ttest of arm selective control
15770014|NCT04695639|Other|Hand Held Dynamometer|Hand held dynamometer (Camry Digital Hand Dynamometer Grip Strength, Model EH101-37, China) will be used to assess hand grip strength of the affected upper extremity. It is generally small, portable and relatively cheap reliable measurement instruments to measure muscle strength of the arm and hand in children with spastic cerebral pasly. It is used to measure strength; maximal voluntary isometric contraction; objectively in kilograms, pounds or newtons. Such devices have been proven to have good to excellent reliability in different populations. It represents an easily accessible way to assess muscle weakness in children with cerebral palsy and the overall reliability is considered to be good.
15770015|NCT04695639|Other|Quality of Upper Extremity Skill Test|It will be used to assess function of the affected upper extremity. It is a reliable and valid outcome measure designed to evaluate movement patterns and hand function in children with cerebral palsy. It is designed to be used with children who have neuromotor dysfunction with spasticity and has been validated with children from 18 months to 8 years of age.
15770016|NCT04695626|Procedure|The combination of bone marrow stimulation and modified suture bridge(Greenhouse tec)|According to the anteroposterior diameter of the injury, single or double high braided thread were used to suture the tendon in a modified Mason Allen way without knotting. Bone marrow stimulation was carried out in the footprint area of rotator cuff. A 2.0 mm diameter cone was created with a depth of 1 cm and a spacing of 5 mm. Six to eight holes were made due to the diameter of the tear of rotator cuff until blood and fat droplets exudate. Then the threads were passed through the locking eyelet of the lateral row anchor. After tightening the threads, the anchor was screwed in at the distal part of the gteater tuberosity. With this new technique, the rotator cuff was repaired by one lateral row anchor without medial row knotting.
15770017|NCT04695613|Drug|Aminoacid|amino acid infusion 150 ml/kg/hr starting preoperative
15770018|NCT04695613|Drug|Magnesium sulfate|magnesium sulphate bolus and infusion 60 mg/kg starting preoperative
15770019|NCT04695600|Drug|Botulinum Toxin Type A Injection [Botox]|100 units of Botulinum toxin A (Botox, Allergan, CA) under endoscopic guidance will be injected in the cricopharyngeus muscle
15770020|NCT04695587|Diagnostic Test|123 MIBG scintigraphy testing|123 MIBG scintigraphy testing in subacute phase and 12 months after the acute episode in a subgroup of patients according to individualized needs.
15770021|NCT04695587|Diagnostic Test|MSNA|MSNA in subacute phase and 12 months after the acute episode
15770022|NCT04695587|Diagnostic Test|ABPM|ABPM in subacute phase and 12 months after the acute episode
15770023|NCT04695587|Diagnostic Test|ECHO|ECHO in subacute phase and 12 months after the acute episode
15770024|NCT04695587|Diagnostic Test|24hour ECG|24hour ECG in subacute phase and 12 months after the acute episode
15770025|NCT04695587|Diagnostic Test|CMR|CMR in 12 months after the acute episode
15770026|NCT04695574|Procedure|Some clinical evaluation performance tests together with procedure of Closed Kinetic Chain Lower Extremity Stability Test|Clinical evaluation methods
15770027|NCT04695561|Other|Self Myofascial Relaxation|Total of 12 times for 6 weeks
15770028|NCT04695561|Other|Instrument Assisted Soft Tissue Mobilization|Total of 12 times for 6 weeks
15770029|NCT04695561|Other|Only Exercise (Control)|Every day for 6 weeks
15770030|NCT04695548|Other|Concentric contraction exercise|The participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of raising the shoulder against the resistance of the elastic band, slowly and for 5 seconds
15770031|NCT04695548|Other|Isometric contraction exercise|The participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of raising the shoulder and maintaining the tension of the elastic band for 5 seconds
15770032|NCT04695548|Other|Eccentric contraction exercise|The participant will be placed in a standing position, with the shoulders positioned in the scapular plane. A medium stiffness Theraband elastic band will be placed between the participant's ipsilateral foot on the side on which the dry needling technique was applied and the acromio-clavicular joint on the same side.The exercise will consist of asking the participant to lower their shoulder, against the resistance of the elastic band, in a slow and controlled manner for 5 seconds.
15770033|NCT04695548|Other|Analytic passive stretching|The patient remains supine position. The analytical passive stretch of the upper trapezius will be performed only once, bringing the muscle to the limit of elastic tension perceived by the subject. The passive stretching technique will be held for 30 seconds.
15770034|NCT04695522|Biological|ADR-002K administration|ADR-002K administration
15770035|NCT04695509|Drug|"moderate propofol sedation (Bispectral index monitoring 70-90; The Richmond Agitation and Sedation scale (RASS) -2 - -3"|Two peripheral venous blood catheters are placed after admission in the operation room and venous blood sample is taken (10 ml). Complete monitoring of vital functions is provided (pulse oximetry, noninvasive blood pressure, electrocardiography, bispectral index monitoring). Doctor anesthesiologist performs regional anesthesia and propofol light-moderate sedation starts. The second blood sample (10 ml) is taken 35-40 minutes after the start of propofol sedation. The third blood sample (10 ml) is taken after emergence from propofol sedation (10-15 minutes after propofol discontinuation). Blood samples are centrifuged and received plasma is frozen at a temperature of -20 C*. After 26 patients are recruited, the blood plasma is analyzed by conducting the enzyme-linked immunosorbent assay (ELISA) of neuromediators (Dopamine, serotonin, Gamma-aminobutyric acid (GABA), acetylcholine, noradrenaline).
15770036|NCT04695509|Drug|"deep propofol sedation (BIS 60-70, The Richmond Agitation and Sedation scale (RASS) -4)"|Two peripheral venous blood catheter is placed after admission in the operation room and venous blood sample is taken (10 ml). Complete monitoring of vital functions is provided (pulse oximetry, blood pressure, electrocardiography, bispectral index monitoring). Doctor anesthesiologist performs regional anesthesia and propofol deep sedation starts. The second blood sample (10 ml) is taken 35-40 minutes after the start of propofol sedation. The third blood sample (10 ml) is taken after emergence from propofol sedation (10-15 minutes after propofol discontinuation). Blood samples are centrifuged and received plasma is frozen at a temperature of -20 C*. After 26 patients are recruited, the blood plasma is analyzed by conducting enzyme-linked immunosorbent assay (ELISA) of neuromediators (Dopamine, serotonin, Gamma-aminobutyric acid (GABA), acetylcholine, noradrenaline).
15770037|NCT04695496|Device|Theta bust stimulating|Theta burst stimulation with Magstim super rapid 2, over SMA. 3 section per day, for 5 days, total 15 sections.
15770038|NCT04695483|Drug|Corifollitropin alfa|Controlled ovarian stimulation long-acting protocol
15770039|NCT04695483|Drug|Follitropin Beta|Daily controlled ovarian stimulation protocol
15770040|NCT04695470|Drug|Fruquintinib and Sintilimab|"fruquintinib 5mg qd for 2 weeks on and 1 week off, Q3w
~Sintilimab 200mg iv, Q3w"
15770041|NCT04695444|Device|nasotracheal tube (Ring-Adair-Elwin)|different materials for nasotracheal intubation conventional PVC tube
15770042|NCT04695444|Device|nasotracheal tube (Ring-Adair-Elwin)|different materials for nasotracheal intubation conventional PVC tube with rubber suction catheter
15770043|NCT04695444|Device|nasotracheal tube (portex)|different materials for nasotracheal intubation velvet soft PVC tube.
15770044|NCT04695418|Dietary Supplement|Rice Germ|The rice germ was taken every day (25 g in the morning with breakfast and 25 g in the afternoon as snacks) for four weeks
15770045|NCT04695418|Combination Product|Placebo|An isocaloric wheat germ-based supplement was taken every day (25 g in the morning with breakfast and 25 g in the afternoon as snacks) for four weeks
15770046|NCT04695405|Genetic|Saliva Genetic Samples|Patients will provide two saliva swabs containing genetic materials.
15770047|NCT04695392|Other|R2 Bundle|"During the intervention phase subjects will receive R2.
~Focused effort to replicate the child's pre-hospitalization daily routine (bedtime/wake time, bedtime/arousal routine, nap time, feeding schedule, active periods),
~Cycled day-night lighting and modulation of sound to match the child's routine,
~Minimal yet effective sedation using a nurse-implemented goal-directed sedation plan (RESTORE),
~Night fasting with bolus enteral daytime feedings,
~Early, developmentally-appropriate, progressive exercise and mobility (PICU Up!),
~Continuity in nursing care, and
~Parent diaries."
15770048|NCT04695366|Other|No intervention|No intervention
15770049|NCT04695353|Procedure|Telemedicine: Virtual visits (videoconferences, texts)|Patients will receive clinical care by using telemedicine (virtual visits)
15770050|NCT04695340|Dietary Supplement|Psyllium|Psyllium is given to patients
15770051|NCT04695327|Biological|TILT-123|TNFalpha and IL-2 coding oncolytic adenovirus TILT-123
15770052|NCT04695314|Device|Massage|Foot reflexology board (JAPAN TSUBO HH-700) with massage focused at the base of the second and third toes
15770053|NCT04695314|Procedure|Experimental insert|Raised shoe insert, insert used for massage
15770054|NCT04695314|Procedure|Sham insert|Flat shoe insert, insert used for massage
15770055|NCT04695301|Other|Rehabilitation protocol through a digital platform|During 3 months the patients will participate in a rehabilitation program through a digital platform
15770056|NCT04695262|Procedure|EUS-FNB|Endoscopic ultrasound (EUS)-guided fine needle biopsy (FNB)
15770057|NCT04695249|Behavioral|Exposure intervention using 360 degree videos|The intervention consists of eleven sessions. The first five sessions are dedicated to functional assessment and psychoeducation. The second five sessions are dedicated to exposure in 360-degree videos. The last session is provided for relapse prevention.
15770058|NCT04695236|Device|ZOLL Intravascular Temperature Management system, Quattro catheter|ZOLL Intravascular Temperature Management system, Quattro catheter
15770059|NCT04695223|Drug|Arsenic Trioxide|Refractory cancer patients without standard-of-care harboring TP53 mutation received Arsenic Trioxide Injection (0.16mg/kg,d1-5,ivgtt,28days as a duration)
15770060|NCT04695210|Behavioral|Virtual peer-to-peer support|See arm description
15770061|NCT04695197|Drug|Artemether-lumefantrine (AL)|Current first line treatment of malaria. Dose: Bodyweight (kg) Dose (mg) of artemether + lumefantrine given twice daily for 3 days (total, six doses) 5 to < 15 20 + 120 15 to < 25 40 + 240 25 to < 35 60 + 360 >=35 80 + 480; Twice daily for 3 days (total, six doses)
15770062|NCT04695197|Drug|Pyronaridine-artesunate (PA)|Antimalarial; Dose: Body weight (kg) Dose (mg) of pyronaridine + aresunate given once daily for 3 days (total, three doses) 5 to < 8 60 + 20 8 to <15 120 + 40 15 to <20 180 + 60 20 to <24 kg 180 + 60 24 to <45 360 + 120 45 to <65 540 + 180 >=65 720 + 240; Once-daily for 3 days (total, three doses).
15770063|NCT04695184|Diagnostic Test|ICG-NIRF Imaging|intraoperative NIRF Imaging using the fluorescence agent ICG (indocyanine-green) at regions of interest before (T1) + after pouch construction (T2) + after ileoanal anastomosis (T3)
15770064|NCT04695171|Device|LINX Reflux Management System|"The LINX Reflux Management System consists of a series of titanium beads each with a magnetic core connected with independent titanium wires to form an annular shape when implanted. The attractive force of the magnetic beads is designed to provide additional strength to keep a weak lower esophageal sphincter (LES) closed. During swallowing, the magnetic beads slide away from each other on the independent titanium wire links to allow esophageal distention as the bolus passes by."
15770065|NCT04695171|Procedure|Fundoplication|A surgical procedure where the fundus of the stomach is wrapped around and sutured to the distal esophagus to restore the function of the lower esophageal sphincter in limiting stomach contents from refluxing into the esophagus.
15770066|NCT04695158|Drug|COVID-19 group (Group I)|Routine COVID-19 treatment
15770067|NCT04695158|Drug|Type II Diabetes Mellitus and COVID-19 group (Group II)|Routine Type II Diabetes Mellitus and COVID-19 treatments
15770138|NCT04694625|Other|Conventional Physical Therapy|• Rapid post-operative mobilization • Range of motion exercises started • Passive extension by placing pillow under foot • Flexion-by dangling the leg over the side of bed • Muscle strengthening exercises • Weight bearing is allowed on 1st post-operative
15770240|NCT04693780|Other|Structured guide|Structured guide
15770241|NCT04693780|Other|List|List
15770068|NCT04695145|Behavioral|Aerobic exercise in group|"Progression
~The goal with every new week should be making every workout a little bit harder than the week before.
~Strength sessions
~Week 1-6: 12-18 reps x 2 set per exercise and muscle 30 s rest between exercises
~Week 7-12: 10-12 reps x 3 set per exercise and muscle 20 s rest between exercises
~Adding weight with gym equipment or changing body position in the exercises to succeed with the rep scheme and making it harder as the group develop their physical and mental ability.
~Conditioning sessions
~Week 1-6: 75 seconds work time x 1 set per exercise 30 seconds of rest between exercises
~Week 7-12: 50 seconds work time x 2 set per exercise 20 seconds of rest between exercises
~Mixed sessions
~Week 1-6: 35 s work time per exercise 25 s rest between exercises x 2 rounds
~Week 7-12: 45 s work time per exercise 15 s rest between exercises x 2 rounds"
15770069|NCT04695145|Behavioral|Group sessions with leisure activities|The control group will receive leisure activity in a group setting for one hour three times a week for 12 weeks. The sessions will be held at the same weekdays and about the same hours as the exercise group sessions. The same group leaders as in the exercise sessions will participate in leisure sessions and will support the adolescents through reminders and reassurance before and during the sessions to enhance adherence. The sessions will start with a check in on feelings, recent events and difficulties (i.e. supportive listening but not any interventions) followed by non heart rate increasing activities, such as playing games or watching movies together.
15770070|NCT04695132|Behavioral|Illness Management and Recovery treatment programme|The Illness Management and Recovery treatment programme is a psychosocial treatment aimed at attaining illness management skills and promoting a sense of personal recovery amongst patients with serious mental illness. The original treatment protocol has been translated to Swedish and adapted to a forensic mental health setting. The treatment consists of ten chapters containing information and practical exercises relating to topics relevant for mental health and mental health recovery. These topics include medication use, stress reduction, problem solving, recovery goals and navigating the forensic mental health system. Participants are assigned practical homework and tasks to be completed outside of treatment sessions. Group sessions are conducted to present and discuss treatment material. Individual sessions are used to rehearse treatment content, personalize the treatment and review progress in achieving tasks agreed upon in the group setting.
15770071|NCT04695106|Drug|Ticagrelor|Within 72 hours post PCI, patients will be randomized in a 1:1 ratio to receive one of the two treatments: dual therapy with ticagrelor (90 mg twice daily for one month, followed by 60 mg twice daily up to 12 months) plus dabigatran (150 mg twice daily or 110 mg twice daily; standard of care) or triple therapy with clopidogrel (75 mg once daily) plus aspirin (75 mg once daily) plus dabigatran (150 mg twice daily or 110 mg twice daily), according to current guidelines. Study treatment will be continued for 12 months.
15770072|NCT04695106|Drug|Dabigatran Etexilate|Within 72 hours post PCI, patients will be randomized in a 1:1 ratio to receive one of the two treatments: dual therapy with ticagrelor (90 mg twice daily for one month, followed by 60 mg twice daily up to 12 months) plus dabigatran (150 mg twice daily or 110 mg twice daily; standard of care) or triple therapy with clopidogrel (75 mg once daily) plus aspirin (75 mg once daily) plus dabigatran (150 mg twice daily or 110 mg twice daily), according to current guidelines. Study treatment will be continued for 12 months
15770073|NCT04695106|Drug|Aspirin|Within 72 hours post PCI, patients will be randomized in a 1:1 ratio to receive one of the two treatments: dual therapy with ticagrelor (90 mg twice daily for one month, followed by 60 mg twice daily up to 12 months) plus dabigatran (150 mg twice daily or 110 mg twice daily; standard of care) or triple therapy with clopidogrel (75 mg once daily) plus aspirin (75 mg once daily) plus dabigatran (150 mg twice daily or 110 mg twice daily), according to current guidelines. Study treatment will be continued for 12 months
15770074|NCT04695106|Drug|Clopidogrel|Within 72 hours post PCI, patients will be randomized in a 1:1 ratio to receive one of the two treatments: dual therapy with ticagrelor (90 mg twice daily for one month, followed by 60 mg twice daily up to 12 months) plus dabigatran (150 mg twice daily or 110 mg twice daily; standard of care) or triple therapy with clopidogrel (75 mg once daily) plus aspirin (75 mg once daily) plus dabigatran (150 mg twice daily or 110 mg twice daily), according to current guidelines. Study treatment will be continued for 12 months
15770075|NCT04695093|Other|Ultra Low Emission Zone (ULEZ)|"The ULEZ comprises a Central London zone, implemented on 8th April 2019, within which polluting vehicles are subject to a charge. Using number plate recognition technology, a daily penalty charge notice is issued for vehicles entering this central zone not meeting the standard of Euro 4 for petrol, Euro 6/VI for diesel, and Euro for motorcycles.
~The ULEZ will subsequently be extended to include:
~In 2020, a London-wide ULEZ for heavy duty vehicles (HDV) within the LEZ boundary (green zone). HDVs not meeting Euro 6 standard will be charged daily.
~In 2021, an Inner London ULEZ area for all light duty vehicles (LDV) within the boundary of the North and South Circular Roads (yellow zone). Vehicles not meeting the above criteria will be charged daily as for the Central London area."
15770076|NCT04695080|Drug|Cladribine (MAVENCLAD®)|"Cladribine (MAVENCLAD®) 3.5mg/kg, administered as weight-adjusted 10mg tablets in two treatment courses (12 months apart) lasting 8- 10 days each.
~Cladribine (MAVENCLAD®) 10mg available in blister packs of 1 tablet, 4 tablets and 6 tablets."
15770077|NCT04695080|Drug|Placebo|"Placebo administered as weight adjusted tablets in two treatment courses (12 months apart) lasting 8-10 days each.
~Placebo 10mg available in blister packs of 1 tablet, 4 tablets and 6 tablets."
15770078|NCT04695067|Behavioral|Central fatigue group|a fatigue protocol that pitchers need to pitch 80 trials in a simulated game
15770079|NCT04695054|Device|Buzzy device plus EMLA cream|EMLA cream will be applied 60 minutes before the needle procedure; the Buzzy device will be used during the procedure
15770080|NCT04695054|Drug|Only EMLA cream|EMLA cream will be applied 60 minutes before the needle procedure
15770081|NCT04695041|Drug|PBI-4050/ Placebo|Participants receive either 800mg PBI-4050 capsules or placebo, twice a day for 14 days
15770082|NCT04695041|Drug|PBI-4050/ Placebo|Participants receive either 1200mg PBI-4050 capsules or placebo, once a day for 14 days
15770083|NCT04695041|Drug|PBI-4050/ Placebo|Participants receive either 1000 mg PBI-4050 capsules or placebo, twice a day for 14 days
15770084|NCT04695041|Drug|PBI-4050/ Placebo|Participants receive either 1200 mg PBI-4050 capsules or placebo, twice a day for 14 days
15770085|NCT04695041|Drug|PBI-4050/ Placebo|Participants receive either 800 mg PBI-4050 capsules or placebo, three times a day for 14 days
15770139|NCT04694612|Drug|Favipiravir|Comparison of clinical improvement and clinical deterioration between those receiving Favipiravir compared to placebo in the patients with mild COVID-19
15770086|NCT04695028|Other|Data collection|"The following data will be collected by the physician: sociodemographic profile, clinical manifestations, comorbidities, laboratory tests,etc.
~Diagnostic performance of different imagery techniques, performance of crystal deposit quantification in ultrasound and Dual-energy computed tomography (DECT), link between co-morbidities and volume of baseline crystal deposits then during monitoring, link between co-morbidities (including cardiovascular events and new diagnoses of co-morbidity) and vascular baseline crystal deposits and during follow-up, link between microcrystalline rheumatism activity and the quantity of crystal deposits in baseline imaging and during follow-up, link between co-morbidities and the evolution of microcrystalline baseline rheumatism and then during follow-up, link between co-morbidities and the evolution of crystal deposition volumes, the concordance of the evaluation of uratic stocks and their evolution between the imagery means."
15770087|NCT04695002|Behavioral|MIRA|Based on the initial assessment, the citizen and professional agree what outcomes the citizen should report in MIRA. This could be pain, mood, sleep quality, energy level, dependent on the priorities of the citizen. Similarly, different activities are reported, e.g. exercise, social activities, prolonged sitting or work-related tasks. The citizen and the professional agree how often the citizen reports the outcomes and tasks, and the citizen is notified by the MIRA-app when it's time for reporting. The data will be visualized in a graph for the professional in the back-end of the system, making it possible for the citizen and the professional to view the same, real-time reported data. This provides the base for discussing and adjusting the course of rehabilitation as symptoms change over time. At the same time, this increases the citizen's knowledge of how symptoms, mood, sleep and activities all interact, thereby giving them the tools better cope with their health condition.
15770088|NCT04695002|Behavioral|Control|Citizens in the control group participate in the standard course of vocational rehabilitation, without the use of MIRA app. Citizens are referred from the jobcenter if the case manager assesses that a health condition limits the citizen's ability to resume work. The typical course of rehabilitation lasts 4-12 weeks, and is managed by a physiotherapist, a psychologist and a physician. Depending on the condition of the citizen, the rehabilitation may be managed by only two of the three professionals. During the course of rehabilitation, the citizen may consult the team with varying frequency. If physical rehabilitation is part of the prescribed rehabilitation, the citizen shows up twice per week for several weeks of supervised exercise, whereas rehabilitation courses where self-management is in focus, only biweekly consultations may be provided. The decisions and planning of contents and duration of the rehabilitation programme is done in collaboration with the citizen.
15770089|NCT04694989|Drug|CKD-386|QD, PO
15770090|NCT04694989|Drug|D013, D326, D337|QD, PO
15770091|NCT04694976|Biological|25-OH Vitamin D measure|As a complement to the off-study prescription, the investigator are taking two 1 mL tubes of extra blood to measure vitamin D, calcium, phosphorus, parathyroid hormone (PTH) and creatinine.
15770092|NCT04694963|Procedure|Blood sample|2 ml venous blood was collected and separated into serum.
15770093|NCT04694963|Procedure|Data collection|"Whether the patient has been vaccinated with DPT vaccine and record the time of vaccination;
~Medication situation of patients in the past year, including rescue drugs, antitussive and expectorant drugs, inhaled corticosteroids and antibiotics;"
15770094|NCT04694963|Procedure|Throat swab|"Before the collection of oropharyngeal swabs, instruct the patient to wash the mouth or gargle, fix the patient's head, open the mouth and expose the throat. If necessary, use a tongue depressor to gently press the tongue.
~Use the swab to wipe the secretion on both sides of the palatal arch, pharynx and tonsil with a sensitive and gentle action, and quickly withdraw the swab to avoid contacting other parts of the mouth.
~Put the swab in the sterile test tube, plug the opening with cotton ball, and send it for inspection and registration in time."
15770095|NCT04694950|Procedure|Usual care|Intravenous morphine according to clinician´s discretion.
15770096|NCT04694937|Device|heart rate variabilty measured by pulse oximetry|"Resting HRV will be measured by Pulse Oximeter BM2000A/Shanghai Berry Electronic Tech Co., Ltd. that is validated for this purpose and is approved by FDA. The measurement, at the patient's fingertip, takes 5 minutes. The measurement will be performed twice - at two consecutive visits at the clinic, as part as the routine follow up of the patient every 3 months.
~HRV will be correlated to demographic and metabolic parameters between patients. In order to reveal whether HRV can serve as a predictor to metabolic disease progression or improvement, HRV will be correlated to metabolic parametrers in the same patient at two time-points."
15770097|NCT04694924|Other|standard of care|"No other procedures than those performed during the usual care for prostate cancer patients will be done. No study medication will be provided as part of participation.
~Clinical outcomes will be reported via predefined electronic forms, integrated into the EHR. Patient-reported outcomes will be collected electronically.
~All treatment decisions will be made at the discretion of the investigator or treating physician."
15770098|NCT04694911|Behavioral|Focus Group|Participate in focus group
15770099|NCT04694911|Other|Interview|Complete cognitive interview
15770100|NCT04694911|Other|Research or Clinical Assessment Tool|Receive OOCAT
15770101|NCT04694898|Behavioral|Standard programme|The control arm will receive national standard programme for women and children under the age of 2 years. This includes 1) national nutrition and health care including iron & folic acid (IFA) supplementation in pregnancy; 2) early initiation and exclusive breastfeeding until 6 months of age; 3) timely introduction of liquid and semi-solid complementary foods; and 4) diversified complementary foods.
15770102|NCT04694898|Behavioral|SURE intervention|"The SURE package includes: 1) promoting diversified agriculture; 2) promoting infant and young child feeding practices; 3) women empowerment in decision making related to agriculture, food and health; and 4) enhanced food security and Water, Sanitation and Hygiene (WASH) practices."
15770104|NCT04694872|Other|Telerehabilitation Based LSVT BIG Exercise Protocol|Lee Silverman Voice Treatment-LOUD therapy is a protocol involving intensive speech therapy, which was initiated at the Lee Silverman Parkinson Center between 1987-1989 to heal hypophonia in individuals with PD. LSVT-BIG, on the other hand, is a protocol derived from LSVT-LOUD, used in neurorehabilitation, consisting of focused large-amplitude functional movements performed with great effort. Maximal Daily exercises consist of seven standard exercises. Functional component tasks, on the other hand, will be created for movements in which the patient has difficulty in daily life activities selected individually based on his complaints. In hierarchical tasks, daily life activities with difficulties will be studied with large amplitudes. Exercises will be applied simultaneously with the physiotherapist over the Zoom application, 4 days a week, 60 minutes a day, 4 weeks protocol respectively.
15770105|NCT04694872|Other|Telerehabilitation Based Functional Balance and Mobility Exercise|"These exercises will be applied simultaneously with the physiotherapist over the Zoom application, 4 days a week and 60 minutes a day for 4 weeks.
~Exercises will get harder with each passing week and its progression will be adjusted to the patient."
15770106|NCT04694859|Device|Transcatheter Aortic Valve Implantation|Transfemoral or transapical Transcatheter Aortic Valve Implantation
15770107|NCT04694846|Drug|Nicotine Replacement|Given NRT via trans-dermal patch, gum, nasal spray, inhaler or lozenges
15770108|NCT04694846|Drug|Bupropion Hydrochloride Controlled-release|Given PO
15770109|NCT04694846|Drug|Varenicline|Given PO
15770110|NCT04694846|Other|Tobacco Cessation Counseling|Receive counseling
15770111|NCT04694846|Other|Questionnaire Administration|Ancillary studies
15770112|NCT04694846|Other|Quality of Life Assessment|Ancillary studies
15770113|NCT04694846|Other|Best Practice|Receive standard treatment
15770114|NCT04694833|Behavioral|Motor and cognitive virtual reality-based assessments|Motor and cognitive testing in virtual reality
15770115|NCT04694833|Behavioral|Motor and cognitive virtual reality-based serious games|Serious games implemented in virtual reality to rehabilitate motor and cognitive impairments.
15770116|NCT04694820|Other|Text Message-Based Navigation Intervention|Receive txt4TKI
15770117|NCT04694820|Other|Survey Administration|Ancillary studies
15770118|NCT04694807|Behavioral|Group-based Cognitive Behavioural Therapy for Complicated Grief Reactions|"CBTgrief is a transdiagnostic psychotherapeutic treatment for complicated grief reactions, i.e., symptoms of prolonged grief disorder as well as post-loss depression, anxiety, and posttraumatic stress. The treatment manual is developed by Professor Paul A. Boelen. CBTgrief includes methods such as psycho-education, homework, exposure, alteration of grief-related negative automatic thoughts, behavioural activation, and goal-oriented work. CBTgrief consists of 12 sessions with a session duration of 2.25 hours for the group format.
~Group-based CBTgrief will follow the same content and exercises for each session as individually delivered CBTgrief."
15770119|NCT04694807|Behavioral|Individually delivered Cognitive Behavioural Therapy for Complicated Grief Reactions|"CBTgrief is a transdiagnostic psychotherapeutic treatment for complicated grief reactions, i.e., symptoms of prolonged grief disorder as well as post-loss depression, anxiety, and posttraumatic stress. The treatment manual is developed by Professor Paul A. Boelen. CBTgrief includes methods such as psycho-education, homework, exposure, alteration of grief-related negative automatic thoughts, behavioural activation, and goal-oriented work. CBTgrief consists of 12 sessions with a session duration of 1 hour for the individually delivered format.
~Individually delivered CBTgrief will follow the same content and exercises for each session as group-based CBTgrief."
15770120|NCT04694794|Other|Educational Brochure|Participants will be provided with Education Brochure developed by the study team to provide information to patients about managing side effects related to chemotherapy
15770121|NCT04694781|Drug|LVGN6051|Route of administration is IV infusion, and the frequency of administration is once every 3 weeks (Q3W). one cycle is 3 weeks, and treatment can be up to 35 cycles if patients receive benefits.
15770122|NCT04694781|Drug|Pembrolizumab|Route of administration is IV infusion, and the frequency of administration is once every 3 weeks (Q3W). one cycle is 3 weeks, and treatment can be up to 35 cycles if patients receive benefits.
15770123|NCT04694768|Behavioral|Rehabilitation|Rehabilitation program
15770124|NCT04694755|Drug|Placebo|On the basis of dextrin and bitter agent, 5% of the drug was used to prepare.Its appearance, weight, color and smell are basically the same as traditional Chinese medicine granule.Tianjiang brand formula granules, in line with GMP standards
15770125|NCT04694755|Drug|Traditional Chinese medicine prescription|Tianjiang brand formula granules, in line with GMP standards
15770126|NCT04694742|Other|data collecting|"Within 24h from ICU admission, the ventilatory efficiency will be assessed by the following Ventilatory Ratio equation:
~Ventilatory Ratio = [minute ventilation (ml/min) × PaCO2 (mm Hg)]/(predicted body weight × 100 × 37.5).
~Where PaCO2 is the partial pressure of carbon dioxide in mmHg in the arterial blood.
~Tha quasi-static compliance will be calculated according to the equation:
~C=Tidal Volume/(Paw plateau - PEEP total)
~where Paw plateau is the airway pressure measured during 4 seconds of inspiratory pause, PEEP total is the airway pressure measured during 4 seconds of expiratory pause.
~In the same time frame, complete blood count, d-dimer, sequential organ failure assessment score, blood gas analysis, haemodynamic and ventilatory parameters will be collected."
15770127|NCT04694729|Other|videoconference-based|Exercises will be done 3 days a week for 6 weeks, with the help of a physiotherapist via video conference.
15770128|NCT04694729|Other|video-based|The exercise video will be sent to the patients and they will do it 3 days a week for 6 weeks. The subjects will be asked to keep an exercise diary and the status of the diaries will be followed by calling once a week.
15770129|NCT04694716|Other|No intervention|No intervention will be applied.
15770130|NCT04694703|Drug|Covid-19 group|Routine COVID-19 treatment
15770131|NCT04694690|Other|Self adhesive resin cement|Self adhesive resin cement
15770132|NCT04694690|Other|Resin cement|Resin Cement system used after surface treatment
15770133|NCT04694677|Drug|women receiving tranexamic acid|women receiving tranexamic acid during myomectomy
15770134|NCT04694677|Drug|women receiving misoprostol|women receiving misoprostol in myomectomy
15770135|NCT04694664|Other|This is an online survey with no intervention.|As this is an online survey about health and wellbeing, there is no intervention.
15770141|NCT04694612|Drug|Remdesivir|Comparison of clinical improvement and clinical deterioration between those receiving Favipiravir compared to Remdesivir Injection in the patients with moderate COVID-19
15770142|NCT04694599|Device|Low flow oxygen|Low flow oxygen delivered via nasal prong or facial mask. The flow rate is adjusted according to oxygen saturation of the patient.
15770143|NCT04694586|Drug|rifampicin|rifampicin 35 mg/kg
15770144|NCT04694586|Drug|pyrazinamide|pyrazinamide 40 mg/kg
15770145|NCT04694586|Drug|HRZE|isoniazid 75 mg + rifampicin 150 mg + pyrazinamide 400 mg + ethambutol 275 mg combination tablets
15770146|NCT04694586|Drug|HR|isoniazid 75 mg + rifampicin 150 mg combination tablets
15770147|NCT04694560|Other|Treatment Free Observation|Participants without evidence of clinical relapse will remain off therapy and continue serial monitoring through end of study at 24 cycles. Participants with clinical relapse will continue to be monitored off therapy through 24 cycles or until meeting criteria for treatment per iwCLL criteria. If participants experience clinical relapse requiring treatment, radiology assessment, disease assessment, and testing for resistance mutations will be performed. Participants will be observed for an additional 12 cycles following start of reintroduction of therapy.
15770148|NCT04694547|Other|There is no intervention, as this is a survey study|Survey
15770149|NCT04694534|Diagnostic Test|Serious game|"The serious game is accessible via an online platform, on a tablet: 4 20-minutes activities sessions per week must be carried out.
~The program format in the serious game form makes possible to simultaneously understand a large number of cognitive functions."
15770150|NCT04694534|Diagnostic Test|Usual HAS care|The control group patients will follow the care they need, according to the HAS recommendations. Non-specific cognitive activities notebooks will be provided to them. They will be instructed to perform the 4 20-minutes sessions per week for 4 months.
15770151|NCT04694521|Procedure|openSide to end colorectal anastomosis .|open Side to end colorectal anastomosis
15770152|NCT04694521|Procedure|open end end to end stapler anastomosis|open end to end stapler anastomosis
15770153|NCT04694508|Device|Headphones (Disok, Alicante, España)|A pair of non-reusable headphones (Disok, Alicante, Spain)
15770154|NCT04694495|Diagnostic Test|16S rRNA gene sequencing of cervical secretions|"16S rRNA gene sequencing of vaginal secretions: using NGS technology to assess the microbiota of the vaginal secretions
~Microecology assessment of vaginal secretions: morphology test, functional assessment and Nugent score assessment of the vaginal secretions are included.
~Genotyping of HPV and detection of sexually transmitted diseases pathogens based on the cervical exfoliated cells
~Thinprep cytologic test of cervical exfoliated cells: to evaluate the grade of cervical intraepithelial neoplasia"
15770155|NCT04694482|Other|Psychometric scale administration|PTSD symptoms are assessed using a specific scale (IES-R) and compared between the two groups
15770156|NCT04694469|Procedure|Closed reduction and percutaneous pinning (CRPP)|Operated for supracondylar humeral fractures
15770157|NCT04694456|Other|cytokines dosage|Mesure of cytokines concentration in serum
15770158|NCT04694456|Procedure|test of walk|patient must walk during 6 minutes on a flat surface
15770159|NCT04694456|Procedure|Manual muscular test|test performed to evaluate the patient muscular weakness
15770160|NCT04694456|Procedure|Motrice fonction mesurement|scale allowing the evaluation of patient posture and upper body movements
15770161|NCT04694443|Procedure|Multidisciplinary tele-health intervention (physical therapy, neurologist, nurse, psychologist)|Non-pharmacological and pharmacological treatment provided by telemedicine plus in-office visits
15770162|NCT04694443|Other|Standard in-office medical care|Non-pharmacological and pharmacological treatment provided in-office visits
15770163|NCT04694430|Procedure|Blood sample|2 ml venous blood was collected and separated into serum.
15770164|NCT04694430|Other|Data collection|"Whether the patient has been vaccinated with DPT vaccine and record the time of vaccination;
~Medication situation of patients in the past year, including rescue drugs, antitussive and expectorant drugs, inhaled corticosteroids and antibiotics;
~Assess COPD using ABCD assessment tool."
15770165|NCT04694430|Procedure|Throat swab|"Before the collection of oropharyngeal swabs, instruct the patient to wash the mouth or gargle, fix the patient's head, open the mouth and expose the throat. If necessary, use a tongue depressor to gently press the tongue.
~Use the swab to wipe the secretion on both sides of the palatal arch, pharynx and tonsil with a sensitive and gentle action, and quickly withdraw the swab to avoid contacting other parts of the mouth.
~Put the swab in the sterile test tube, plug the opening with cotton ball, and send it for inspection and registration in time."
15770166|NCT04694417|Other|Compression stocking|Please see the description of the intervention in another section
15770167|NCT04694417|Dietary Supplement|Magnesium tablet|Please see the description of the intervention in another section
15770168|NCT04694417|Other|Placebo tablet|Please see the description of the intervention in another section
15770169|NCT04694404|Drug|S-1,Oxaliplatin|Oxaliplatin 85 mg/m2 (D1, q2w) and S-1 (40mg BID for body surface area < 1.25 m2; 50mg BID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area >1.5 m2; D1-10, q2w)
15770170|NCT04694391|Genetic|whole exome sequence|To seek genomic characteristics of relapsed esophageal cancer with whole exome sequence.
15770171|NCT04694365|Drug|Fluzoparib|A single oral dose of 50 mg Fluzoparib will be administered.
15770172|NCT04694352|Other|Jumping Exercises|Jumping in place Jump and clap Jump and reach Jump and twist Jump and turn Half jumping jack Jumping side to side Each exercise done for 1 minute, 5 repetitions is session of 1 hour 15minutes
15770173|NCT04694352|Other|Conventional Physical therapy|"Drop and catch a ball Squeeze ball between legs, jump up and catch the ball Walking on a straight line Stand on one leg try to pick object from floor without using hands (do this on both legs) Drop the ball and catch it with both hands Jump up stair with both limbs off the floor simultaneously while holding railing.
~Skipping. At least 5 repetitions for each exercise in session of total 1 hour"
15770174|NCT04694339|Other|Survey|Survey
15770175|NCT04694326|Diagnostic Test|HbA1c|The participants' age, sex, education level, known diseases, unit of hospitalization and inpatient diagnosis were questioned and recorded. Height, weight and waist circumference measurements were taken. Fasting blood sugar and HbA1c measurements were made
15770176|NCT04694313|Device|OPM|Simultaneous MEG SQUID + SEEG acquisition followed by a simultaneous MEG OPM + SEEG acquisition.
15771552|NCT04682743|Drug|normal saline|received intravenous 0.9% normal saline over a 15-minute period.
15770178|NCT04694300|Drug|Acetaminophen|1000 mg by mouth immediately after the completion of implant surgery followed by 1000 mg every 6 hours for 3 days after surgery with a maximum daily dose of 3000 mg.
15770179|NCT04694300|Drug|Tramadol|50 mg by mouth every 6 hours as needed for pain
15770180|NCT04694287|Diagnostic Test|Percutaneous DUS volume flow measurements|Volume flow measurements of the AFV will be obtained using intraprocedural DUS just prior to sheath insertion and at the end of the final balloon dilation, before sheath removal.
15770181|NCT04694274|Device|stabilization splint|The device made of a hard acrylic on stone cast of the upper jaw in the centric relation position. It has a thickness of 1.5 mm at the level of the first molar.
15770182|NCT04694274|Procedure|physical therapy|Home-exercise program included exercises for passive and active stretching, joint mobilization, passive extension, and translational movements to the right, left, and forward.
15770183|NCT04694274|Device|placebo splint|The placebo splint was made of thin heat-treatable foil (0.5 mm). The foil was heated and printed over a plaster model of the upper jaw resulting in a very thin film over the occlusal surfaces of all teeth.
15770184|NCT04694261|Behavioral|SM-ART|Intervention is a group based training delivered by midwives on SM-ART module. These training will consist of 6 sessions, one per week for 90 to 120 minutes each.
15770185|NCT04694248|Drug|Rivaroxaban|For anticoagulant, it is rivaroxaban 20mg once a day for 6 months.
15770186|NCT04694248|Drug|Aspirin|For antiplatelet therapy, it is aspirin 100mg once a day indefinitely.
15770187|NCT04694235|Dietary Supplement|Egg intervention|Eggs are boiled until the white and yolk are firm (ca. 8 minutes) to maintain quality and safety and ensure the eggs are safe for consumption.
15770188|NCT04694222|Device|Nd:YAG laser|For LANAP, the fiber optic tip of the Nd:YAG laser (1064 nm) (Fotona Fidelis AT, USA) was used. For LLLT R24 biostimulation handpiece tip (950-μm) Nd:YAG laser (1064 nm) was used.
15770189|NCT04694209|Procedure|maxillary and mandibular telescopic retained overdentures supported by 4 implants|The wax of the trial denture was converted into heat-cured acrylic resin using conventional packing and flasking techniques. The prosthesis was finished, polished and screwed in the patient's mouth. Engaging (Internal hex) cylindrical, plastic patterns (Octa plastic cylinder, multi unit abutment, Red, Dentis, Daegu -Korea) were used to construct the primary copings of the telescopic prosthesis.The finished primary copings were scanned using a lab scanner (Shera Echo-scan 7. Dental Wings, Montreal-Canada). This was necessary to design and to mill the wax pattern of the secondary copings using CAD/CAM technology (Dental Wings Software, Dental Wings, Montreal -Canada). Secondary coping was designed to properly fit to the primary coping. The framework was then tried in. At that time it was ready for its intra-oral luting to the secondary copings.
15770190|NCT04694209|Procedure|maxillary and mandibular screw retained hybrid prostheses supported by 4 implants|Framework of the hybrid prosthesis is waxed using plastic copings attached to multiunit abutments. once the framework is finished , bite is recorded, teeth are set up and the waxed up prosthesis are tried in. IF accepted the wax is eliminated the wax up denture is converted inti heat cured acrylic resin
15770191|NCT04694196|Device|Dentures in edentulous patients|Making a Complete denture using CN in anterior border of ramus
15770192|NCT04694183|Drug|Paclitaxel + S-1 + anti-PD-1 antibody (Peritoneal metastasis)|"Drug：Paclitaxel
~50mg/m², intravenous drip administration, d1, d8, q3w.
~Drug：Paclitaxel
~20mg/m², intraperitoneal administration, d1, d8, q3w.
~Drug:S-1
~Oral, d1-14, q3w.
~Drug:Camrelizumab
~200mg，Intravenous drip administration, d1, q3w."
15770193|NCT04694183|Drug|SOX regimen + anti-PD-1 antibody (Liver metastasis, para-aortic lymph node metastasis )|"Drug:Oxaliplatin
~Injection: 130mg/m² intravenous drip administration, d1, q3w.
~Drug:S-1
~Oral, d1-14, q3w.
~Drug:Camrelizumab
~200mg，Intravenous drip administration, d1, q3w."
15770194|NCT04694170|Other|additional therapy|Using conventional physiotherapy together with additional yoga exercising and regimen restriction acc to TCM.
15770195|NCT04694170|Other|conventional physiotherapy|Using conventional physiotherapy only.
15770196|NCT04694157|Device|cardiac shock wave therapy|Two target segments of left ventricle will be chosen for all participants. In each target segment, 9 sties will be administered with 200 shots at each site. Low-intensity SW (200 impulses/spot; energy flux 0.09 mJ/mm2), will be administered under electrocardiographic R-wave gating. The entire treatment period will last 3 months with 9 sessions. CSWT will be administered in the first week, followed by a 3-week non-treatment interval.
15770197|NCT04694144|Device|telescoping intramedullary nail|All osteogenesis imperfecta patients with lower limb skeletal deformities corrected with multiple corrective osteotomies and insertion of two parts male and female segments of intramedullary telescoping nail
15770198|NCT04694131|Device|TMS|The intervention of interest will be TMS delivered to the region of the left posterior parietal cortex with the greatest connectivity with the left hippocampus derived from the baseline resting-state fMRI session. This region was chosen because of its dense connections with the hippocampus, allowing stimulation of this location to modulate function of the hippocampal-cortical network. The control intervention target will be vertex, a commonly used active control site which does not influence neural or behavioral activity.
15770199|NCT04694118|Other|rebound therapy|3 days a week in 12 weeks
15770200|NCT04694105|Drug|Dexmedetomidine injection|perineural injection of Bupivacaine 30 ml 0.25% combined with 50 microgram (0.5 ml) peri-neural dexmedetomidine plus 1.5 ml normal saline
15770201|NCT04694105|Drug|Dexamethasone|perineural injection of Bupivacaine 30 ml 0.25% combined with 4 mg peri neural dexamethasone (2 ml)
15770202|NCT04694105|Drug|saline|perineural injection of Bupivacaine 30 ml 0.25% combined with 2 ml normal saline
15770203|NCT04694092|Drug|Intensive heart rate control with landiolol|Intensive heart rate control preferably with the use of short-acting betablocker landiolol in combination with digoxin
15770204|NCT04694092|Drug|Standard approach to heart rate control|Standard heart rate control with intravenous or oral beta-blockers and/or antiarrhythmic in combination with digoxin
15770205|NCT04694079|Procedure|Group 1, CMR-guided/aided VT ablation|"Ablation of the anatomical channels of heterogeneous tissue within the scar"
15770206|NCT04694079|Procedure|Group 2, CMR-aided VT ablation|"Ablation of the electrical conduction channels within the scar"
15770207|NCT04694079|Procedure|Group 3, Electroanatomical guided ablation|Ablation guided by an electro-anatomical system without the aid of CMR
15770208|NCT04694066|Behavioral|Qigong|Qigong Baduanjin, comprising eight standardized movements, will be adopted in the study. It is practiced as a combination of body movements, breath control, and mindful meditation.
15770209|NCT04694066|Behavioral|Light flexibility exercise|The supervised sessions will include seated and standing stretches that target upper (neck, arms, upper back, shoulders, and chest) and lower body (quadriceps, hamstrings, calves, and hips), as well as trunk rotations.
15770210|NCT04694053|Procedure|surgical debridement|The surgical team performed an extended surgical debridement to healthy tissue of external genital, as well as perineal, perianal, and infrapubic regions.
15770211|NCT04694040|Device|Modjaw® device|Analysis of mandibular kinematics with Modjaw® device
15770212|NCT04694027|Drug|Omega 3 fatty acid|omega 3 1000 mg
15770213|NCT04694027|Drug|VitaE|vitamin e 400 mg
15770214|NCT04694014|Behavioral|EI Open ended Pre-Survey and Semi Structured Interview|Provide Interview questions via online survey with informed consent to the participants then contact a 60 minute member checking interview in person or virtually via recorded Zoom sessions for each participant
15770215|NCT04694014|Behavioral|Behavioral and Cognitive Assessment|Use Predictive index for both cognitive and behavioral assessment of the paticipants
15770216|NCT04694014|Behavioral|Geneva Emotional Competence Test (GECO)|Administer the Geneva Emotional Competence Test to each participant
15770217|NCT04694001|Device|Use of the Atalante exoskeleton|A session includes stand-up, walks, exercises with or without the assistance of the exoskeleton, rotation, side and back step, squat and sitting.
15770218|NCT04693988|Behavioral|Case Management|a case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as provide advice about cardiac symptoms and behavioral life style changes
15770219|NCT04693962|Diagnostic Test|Plasmatic Fibroblast Growth Factor-23 by means of ELISA|Plasma levels of FGF-23 will be measured by ELISA
15770220|NCT04693949|Other|NAC|Pretreatment of zirconia RBFDP with nanostructured alumina coating after milling of RBFDP's framework
15770221|NCT04693949|Other|APA|Air-borne particle abrasion of zirconia RBFDPs prior to bonding
15770222|NCT04693936|Combination Product|Nutraceutical Combination Plan|"Multivitamin (My Total Health) 1 tablet per day Vitamin C (My Immuno) 1 scoop per day Calcium-Magnesium combination (My Calmag) 1 scoop per day Omega 3-6-9 My Omega Krill. 1 capsule per day Glutamine (L-Glutamin &Chios Mastiha) 1 tablet per day Probiotics 40 billion 1 capsule per day
~Nutraceuticals will be received daily along with the patient's customary psoriasis/Hashimoto's disease treatment."
15770223|NCT04693923|Procedure|Fluid challenge|Fluid challenge according to the assigned group
15770224|NCT04693910|Other|Multimedia-Based Hormone Therapy Information Program|The multimedia hormone therapy information program lasted 6 weeks and covered 6 topics, namely the recognition of hormone therapy and multimedia information programs, mindfulness, exercise, stress relief, positive thinking, and prevention or reduction of fatigue.
15770225|NCT04693897|Drug|Mirabegron 50 MG|Mirabegron 50mg once daily given to treatment in patients with overactive bladder syndrome
15770226|NCT04693897|Drug|Solifenacin Succinate 5 MG|Solifenacin 5mg once daily given to treatment in patients with overactive bladder syndrome
15770227|NCT04693884|Drug|Cannabis|Cannabis of (~10% THC concentration <1% CBD concentration) will be smoked.
15770228|NCT04693884|Drug|Cannabis|Cannabis of (~10% THC concentration <1% CBD concentration) will be vaporized.
15770229|NCT04693884|Drug|Cannabis|Cannabis of (~10% CBD concentration <1% THC concentration) will be smoked.
15770230|NCT04693884|Drug|Cannabis|Cannabis of (~10% CBD concentration <1% THC concentration) will be vaporized.
15770231|NCT04693871|Device|Transesophageal ultrasound|Patients with nonvalvular atrial fibrillation underwent radiofrequency ablation combined with left atrial appendage closure and recovered to sinus rhythm after the operation. To study the changes of left atrial organization and function of two groups of patients with different left atrial appendage emptying speeds.
15770232|NCT04693858|Behavioral|Child Anxiety Learning Modules (CALM)|CALM is a cognitive-behavioral intervention for childhood anxiety. CALM consists of five modules. The primary components include psychoeducation, relaxation training (C), behavioral exposure (A), cognitive restructuring (L), and relapse prevention (M). There is also an optional parent psychoeducation module. Students randomized to the CALM condition will receive the 5 modules over 8 weeks.
15770233|NCT04693858|Behavioral|Child Anxiety Learning Modules--Relaxation (CALM-R)|CALM-R serves as an active comparison condition to CALM and consists of 5 modules of relaxation skills. The key components of CALM-R include psychoeducation, deep breathing, progressive muscle relaxation, guided imagery, and relapse prevention. Students randomized to the CALM-R condition will receive the 5 modules over 8 weeks.
15770234|NCT04693845|Behavioral|Collaborative Assessment and Management of Suicidality|"CAMS is a suicide-focused intervention that stabilizes the suicidal patient and identifies, targets, and treats patient-defined suicidal drivers-the problems (e.g., trauma, financial issues, relationship loss) that compel a patient to consider suicide. CAMS is theoretically agnostic, patient-centered, and can be used across different suicidal populations and clinical settings."
15770235|NCT04693845|Behavioral|Treatment as Usual|Treatment as Usual was based on the staff, policies, and procedures of the community mental health center Next Day Appointment clinic (CMHC) affiliated with our university. Research therapists and the research psychiatrist were hired from the CMHC staff who followed standard CMHC policies and procedures.
15770236|NCT04693832|Device|5inD|Interactive Mobile Application which is includes five different game (mandala, puzzle, tetris, music, breath exercise)
15770237|NCT04693819|Diagnostic Test|Somatic modulation|"Type of modulations: 3 jaw and 6 cervical spine modulations, 1 control movement (i.e. without any expected somatic modulation effect) Jaw modulations: laterotrusion to the left, laterotrusion to the right and protrusion Cervical spine modulations: isometric flexion, extension and left and right lateroflexion of the head against resistance of the investigator's hand, compression and traction of the cervical spine in sitting position.
~Control movement: the investigator's hand rests against the patient's forehead without any force application"
15770238|NCT04693806|Other|Continuous CO2 Level|Embryos will be cultured in a single, continuous CO2 setting
15770239|NCT04693793|Other|Education Materials and Janssen Test|"Intervention-1- and Intervention-2-arm participants will receive educational materials duplicating what physicians would receive in the real-world market as they adopt the Janssen technology. These materials are comprised of a slide deck, a sample test report, and a frequently asked questions (FAQ) sheet.
~Intervention 1 participants only will receive the Janssen test results whether they select it or not, and Intervention 2 participants will receive the Janssen test results only if they select it during the second round of case simulations."
15770244|NCT04693741|Procedure|secondary alveolar bone graft|"Under general anesthesia, the soft tissue in the gingiva surrounding the alveolar cleft will be injected with 0.5% lidocaine with 1:100,000 parts of epinephrine. At the alveolar cleft site, gingival sulcus incisions will be made on both sides of the cleft. The tissue will then elevated beneath the periosteum. The mucosa of the nasal floor and the oral mucosa will be dissected. Next, the bone particles will be implanted into the bone defect.
~Then, The cleft site will be closed without tension by the advancement of the gingival flaps."
15770245|NCT04693741|Procedure|Harvesting of the autogenous bone graft|Under general anaesthesia ,the soft tissue in the superior iliac crest will injected with 0.5% lidocaine with 1:100,000 parts of epinephrine. The cancellous bone will harvested with an osteotome and then cut into small bone granules.
15770246|NCT04693741|Procedure|Preparation of PRP|10 ml of blood will be collected in vacuum tubes without anticoagulants which are then immediately centrifuged at a rate of 3000 rpm for 10 min. After centrifugation, the resultant product consists of three layers. The topmost layer consisting of acellular PPP (platelet poor plasma), PRF clot in the middle and RBCs at the bottom of the test tube. The attached red blood cells scraped off from it and discarded. The discarded PRF is then mixed with xenograft and placed inside the alveolar defect.
15770247|NCT04693728|Behavioral|Resilient Intrinsic Self-Regulation Strategies in Extremes|The manualized intervention covered resilience strategies organized into four modules: (1) engagement, (2) social relatedness, (3) transformation of pain and (4) building a good life. The modules were delivered in 8 weekly sessions of 90 minutes each.
15770248|NCT04693715|Drug|RNS60|RNS60 injection solution
15770249|NCT04693715|Drug|Placebo|Placebo injection solution
15770250|NCT04693702|Device|Corneal treatment by a low vision aid device|Near infrared light is used to irradiate the cornea to change the modulus of small volumes of anterior stroma. The modulus change produces a change in light distribution onto the retina. Light rays are redirected from dysfunctional areas of the retina to functional areas, thereby improving patient vision.
15770251|NCT04693689|Other|RNA vaccine|We elicit subjects' willingness to receive RNA COVID-19 vaccine
15770252|NCT04693689|Other|20% adoption rate|We elicit subjects' willingness to receive the new vaccine if 20% of the country's population has received it
15770253|NCT04693689|Other|40% adoption rate|We elicit subjects' willingness to receive the new vaccine if 40% of the country's population has received it
15770254|NCT04693689|Other|60% adoption rate|We elicit subjects' willingness to receive the new vaccine if 60% of the country's population has received it
15770255|NCT04693689|Other|80% adoption rate|We elicit subjects' willingness to receive the new vaccine if 80% of the country's population has received it
15770256|NCT04693689|Other|Conventional vaccine|We elicit subjects' willingness to receive conventional COVID-19 vaccine
15770257|NCT04693689|Other|0% adoption rate|We elicit subjects' willingness to receive the new vaccine if 0% of the country's population has received it
15770258|NCT04693676|Biological|CD19/CD20-directed CAR-T cells|Autologous 2nd generation CD19/CD20-directed CAR-T cells, single infusion intravenously
15770259|NCT04693663|Procedure|Relex-Smile surgery|surgery using Relex-Smile
15770260|NCT04693650|Device|NeuroBlock UHF stimulation|NeuroBlock ultrahigh frequency (UHF) stimulation with 500kHz intra-pulse
15770261|NCT04693637|Biological|Viralym-M Cells|Infusion
15770262|NCT04693637|Biological|Placebo (visually identical to Viralym-M)|Infusion
15770263|NCT04693624|Other|Hormonal levels|"A total of ten (10) blood samples (2ml/each) will be collected during the study for subsequent analysis of progesterone, hCG, inhibin-A, and 17-OH-progesterone:
~Day of triggering (before the injection of hCG, appx. 6 pm) Twelve (12 hours) after hCG injection (appx. at 6 am) Twenty-four (24) hours after hCG injection (appx. at 6 pm) Thirty-six (36) hours after hCG injection (appx. at 8 am, 2 hours after OPU) One (1) day after OPU (60h after hCG) (appx. at 6 am) Two (2) days after OPU (84h after hCG) (appx. at 6 am) Three (3) days after OPU 108h after hCG) (appx. at 6 am) Four (4) days after OPU (132h after hCG) (appx. at 6 am) Five (5) days after OPU (156h after hCG) (appx. at 6 am) Six (6) days after OPU (180h after hCG) (appx. at 6 am)"
15770264|NCT04693611|Behavioral|Individual cognitive stimulation therapy (iCST)|The intervention group will receive 24 individual CS sessions per participant. Each session will last approximately 45 minutes and will have the following structure: session introduction (5 minutes); reality orientation (10 minutes); stimulation of cognitive domain (25 minutes); session closure (5 minutes). The sessions will be led by a previously trained therapist. The intervention program will include several activities based on the principles of CS and adjusted for participants without any neurocognitive disorder.
15770265|NCT04693611|Procedure|Functional near-infrared spectroscopy (fNIRS)|The acquisition by fNIRS will be performed in each CS session in four regions of interest (ROIs) in the prefrontal cortex: left dorsolateral prefrontal cortex (LDLPFC); left medial prefrontal cortex (LMPFC); right medial prefrontal cortex (RMPFC); right dorsolateral prefrontal cortex (RDLPFC).
15770266|NCT04693598|Biological|FBX-101|A replication-deficient adeno-associated virus gene transfer vector expressing the human galactocerebrosidase (GALC) cDNA will be delivered one-time through a venous catheter inserted into a peripheral limb vein.
15770267|NCT04693585|Behavioral|MESSSSAGE - live|mHealth education and social support intervention, synchronous via call
15770268|NCT04693585|Behavioral|MESSSSAGE - asynchronous|mHealth education and social support intervention, asynchronous via text
15770269|NCT04693559|Procedure|secondary alveolar bone graft|Under general anaesthesia, the soft tissue in the gingiva surrounding the alveolar cleft will injected with 0.5% lidocaine with 1:100,000 parts of epinephrine. At the alveolar cleft site, gingival sulcus incisions will made on both the sides of the cleft. The tissue will then elevated beneath the periosteum. The mucosa of the nasal floor and the oral mucosa will dissected. Next, the bone particles will implanted into the bone defect. The cleft site will closed without tension by advancement of the gingival flaps
15770270|NCT04693559|Procedure|harvesting of the autogenous bone graft|osteotome and then cut into small bone granules. The bone granules will then carefully placed into a syringe and pressed to its densest state by pushing the plunger
15770271|NCT04693559|Procedure|Nanocrystalline Hydroxyapatite|Nanocrystalline Hydroxyapatite will be used to fill the alveolar defect
15770272|NCT04693546|Diagnostic Test|LifeKit Prevent Colorectal Neoplasia Test|Procedure: Colonoscopy
15770273|NCT04693546|Diagnostic Test|FIT Test|Procedure: Colonoscopy
15771733|NCT04681430|Drug|Camostat Mesilate|Tablets over 7 days, daily dose of 600 mg split into 3 doses
15770274|NCT04693533|Drug|Fremanezumab Prefilled Syringe [Ajovy]|The treatment is 225 mg (dissolved in 1.5 ml saline) fremanezumab. Fremanezumab (Ajovy) is a month-long-acting anti-CGRP injection that patients are taught to self-administer at home.
15770275|NCT04693520|Drug|ALZ-801|ALZ-801 265 mg twice daily (BID)
15770276|NCT04693507|Drug|teverelix TFA 120 mg|Teverelix TFA 240 mg Day 0 and 120 mg every 6 weeks from week 6 to week 24
15770277|NCT04693507|Drug|teverelix TFA 90 mg|Teverelix TFA 180 mg Day 0 and 90 mg every 4 weeks from week 4 to week 24
15770278|NCT04693494|Other|Training program|Training program consisting in 4 sessions with information about milestones to achieve and advices for motor development. Triptychs and short videos containing the main points containing the main points.
15770279|NCT04693481|Other|nature exposure|Nature exposure has different ways, such as walk in the real nature environment; viewing nature photos. Two main reasons make this study will not use the real nature environment: (1) the limitation of time before or amid the soccer competition; (2) the pandemic situation does not allow people go outside as frequently as before. Therefore, the current study will select some nature photos, which are restorative environments and can restore directed attention to counteract mental fatigue.
15770280|NCT04693468|Drug|Axitinib|Given PO
15770281|NCT04693468|Drug|Crizotinib|Given PO
15770282|NCT04693468|Drug|Palbociclib Isethionate|Given PO
15770283|NCT04693468|Drug|Talazoparib Tosylate|Given PO
15770284|NCT04693455|Drug|ZD03|ZD03 capsule
15770285|NCT04693455|Other|Placebo|placebo capsule
15770286|NCT04693442|Other|taking of blood, urine and blood samples and objective scar assessment|blood, urine and skin tissue sampling & scar assessment questionnaires
15770287|NCT04693429|Drug|Bepotastine Besilate|Bepotastine Besilate 1.5% QID (quater in die) for 7 days
15770288|NCT04693416|Other|Intrapersonal Stigma Reduction|Brief intervention for stigma reduction
15770289|NCT04693416|Other|Interpersonal Stigma Reduction|Brief intervention for support persons of intrapersonal intervention participants.
15770290|NCT04693403|Procedure|HFNC|40-60l/min humidified oxygen by nasal cannula
15770291|NCT04693403|Procedure|CPAP|oxygen therapy by Continuous positive airway pressure face mask or helmet mask
15770292|NCT04693403|Procedure|Standard Oxygen|Oxygen therapy by low flow (upto 15l/min) by Non-rebreather face mask
15770293|NCT04693390|Procedure|Acupuncture|Application of acupuncture
15770294|NCT04693377|Procedure|Cryosurgery|Undergo cryoablation
15770295|NCT04693377|Other|Quality-of-Life Assessment|Ancillary studies
15770296|NCT04693377|Radiation|Stereotactic Body Radiation Therapy|Undergo stereotactic body radiation therapy
15770297|NCT04693364|Other|Decision Aid|Use 3D printed breast model
15770298|NCT04693364|Procedure|Discussion|Participate in consultation
15770299|NCT04693364|Other|Questionnaire Administration|Complete questionnaires
15770302|NCT04693338|Other|Quality-of-Life Assessment|Ancillary studies
15770303|NCT04693338|Other|Questionnaire Administration|Ancillary studies
15770304|NCT04693338|Other|Supportive Care|Receive ICP tasks
15770305|NCT04693325|Procedure|Prolonged normothermic machine perfusion|First, a cohort of DCD kidneys (n=6) will be subjected to 1 hour of NMP and subsequently transplanted [NMP1]. Before extending the duration, secondary endpoints will be evaluated. Thereafter, the duration of NMP will be prolonged to 3 hours (n=6) [PNMP3] and consequently 6 hours (n=6) [PNMP6].
15770306|NCT04693312|Drug|Depo medrol|local injection
15770307|NCT04693299|Diagnostic Test|colonoscopy|A colonoscopy scheduled within the normal pathway of care will be performed. No interventions will be performed.
15770308|NCT04693286|Biological|novel oral polio type 2 vaccine (nOPV2)|• nOPV2 (C1) is a live-attenuated serotype-2 poliovirus that was derived from a modified Sabin type-2 infectious cDNA clone and propagated in Vero cells (S2/cre5/S15domV/rec1/hifi3). Placebo contain sucrose in buffer.
15770309|NCT04693286|Other|Placebo|Placebo contains no active ingradients, only sucrose in buffer
15770310|NCT04693273|Other|Decision Aid for Surgical Modality Choice|A novel decision aid that helps surgical patients choose between Wide-Awake carpal tunnel release and traditional tourniquet surgery. It involves an orientation-memory-concentration test to test if patients are cognitively capable of making decisions, then the decision aid table that has similarities and differences between the two modalities, and a few survey questions that help the investigators know what the patients prefer. Finally, patients finish the decision conflict test to see how confident these patients are about their preference.
15770311|NCT04693260|Device|Visual Acuity with a Hand-held Device Supported by Mobile App.|The Insight will be compared to a standard ETDRS eyechart
15770312|NCT04693247|Device|EQ103|Refraction device
15770313|NCT04693234|Drug|Tislelizumab|Administered as specified in the treatment arm
15770314|NCT04693234|Drug|Ociperlimab|Administered as specified in the treatment arm
15770315|NCT04693221|Other|Choice of VNS set of parameters based on the lowest PLI|Vagal nerve stimulation according to PLI results.
15770316|NCT04693221|Other|EEG|Patient will have an EEG and 12 sets of parameters will be tested. EEG results will be analyzed which will allow to determine the set involving the lowest phase lag index.
15770317|NCT04693208|Device|Laser therapy|Laser treatment parameters will be two combined wavelength (660 and 970 nm), 3.2 Watt peak power, 320 milliWatt/cm2, 36.8 Joule/cm2 fluency, and 50% frequency, for a total time of 3 minutes for each site
15770318|NCT04693195|Drug|BLU-5937|Oral administration of BLU-5937 tablets
15770319|NCT04693195|Drug|Placebo|Oral administration of matching placebo for BLU-5937 tablets
15770320|NCT04693182|Other|Shift schedule without quick returns|The intervention entails implementing a shift schedule which abolishes or substantially reduces the number of quick returns (less than 11 hours of rest between two shifts) for a six-month intervention period.
15770343|NCT04693000|Drug|Arsenic Keratosis lesion or nodular size observation after 12 weeks of therapy with solasodine ointment|An ointment containing solasodine extract of solanum melongena peel origin applied to patients with palmar arsenical keratosis; dose-twice daily for 12 weeks.Keratotic nodular size observation after 12 weeks
15770321|NCT04693169|Drug|11C-Choline|1、PSMA137 labeled with [Al18F] will be used as a molecular imaging tracer for PET/CT scanning。 2、11C-choline (0.05-0.1mCi/kg) was injected intravenously in a week after the [Al18F]PSMA137 PET/CT examination, and imaging of the head and body cadres was performed 20 min after the injection using Philips Gemini TF16 or Siemens Biograph M-CT flow PET/CT
15770322|NCT04693156|Procedure|unilateral ultrasound-guided oblique subcostal TAP block with %0.5 Bupivacaine 10ml + %1 Prilocaine 10ml + %0.9 NaCl 10ml|In the supine position, after the skin sterilization, ultrasound with a high-frequency linear probe will be placed subcostally and from the xiphoid to the right iliac crest obliquely. The rectus abdominis and underlying transversus abdominis muscles will be identified. The local anesthetic solution (%0.5 Bupivacaine 10ml + %1 Prilocaine 10ml + %0.9 NaCl 10ml) will be injected after negative aspiration to the transversus abdominis plane between the rectus abdominis and transversus abdominis muscles along the oblique subcostal line.
15770323|NCT04693156|Procedure|unilateral ultrasound-guided oblique subcostal TAP block with %0.9 NaCl 30ml|In the supine position, after the skin sterilization, ultrasound with a high-frequency linear probe will be placed subcostally and from the xiphoid to the right iliac crest obliquely. %0.9 NaCl 30ml will be injected after negative aspiration to the transversus abdominis plane between the rectus abdominis and transversus abdominis muscles along the oblique subcostal line.
15770324|NCT04693156|Procedure|unilateral ultrasound-guided posterior TAP block with %0.5 Bupivacaine 10ml + %1 Prilocaine 10ml + %0.9 NaCl 10ml|After the oblique subcostal TAP block, the operation table will be slightly turned left laterally for better visualization of the blocking area. The same high-frequency linear ultrasound (Esaote MyLab5) probe will be placed over the postero-lateral abdominal wall, posterior of the mid-axillary line between the costal margin and iliac crest. After the identification of the internal abdominis, transversus abdominis, and quadratus lumborum muscles, the needle will be advanced into the transversus abdominis plane between the internal abdominis and transversus abdominis muscles, at the aponeurosis of quadratus lumborum and these muscles. The local anesthetic solution (%0.5 Bupivacaine 10ml + %1 Prilocaine 10ml + %0.9 NaCl 10ml) will be injected after negative aspiration.
15770325|NCT04693156|Procedure|unilateral ultrasound-guided posterior TAP block with %0.9 NaCl 30ml|After the oblique subcostal TAP block, the operation table will be slightly turned left laterally for better visualization of the blocking area. The same high-frequency linear ultrasound probe will be placed over the postero-lateral abdominal wall, posterior of the mid-axillary line between the costal margin and iliac crest. After the identification of the internal abdominis, transversus abdominis, and quadratus lumborum muscles, the needle will be advanced into the transversus abdominis plane between the internal abdominis and transversus abdominis muscles, at the aponeurosis of quadratus lumborum and these muscles. %0.9 NaCl 30ml will be injected after negative aspiration.
15770326|NCT04693143|Other|A randomized controlled open-label clinical trial.|This was a single-center; open-label randomized controlled trial performed at a Pediatric Intensive Care Unit (PICU) in tertiary care hospital
15770327|NCT04693130|Behavioral|Mindfulness-based prenatal education|Mindfulness-based prenatal education involves mindfulness breathing and other skills with mindfulness meditations.
15770328|NCT04693130|Behavioral|Application for prenatal education|Application for prenatal education involves daily mood's record and some mindfulness-based suggestions which is helpful to relieve negative mood.
15770329|NCT04693130|Behavioral|Hospital-based antenatal education|Hospital-based antenatal education involves all aspects of pregnancy, childbirth and postpartum.
15770330|NCT04693117|Other|Interval Training|All individual of interventional group participated in an interval training program, which comprised of 3 days/week for twelve weeks. A booklet was given to each participant containing instructions and guideline about interval training. The interval training program was introduced as prescribed previously.17 After the workout, a cool down period of 5 minutes was given during which they perform paddling with low speed. All training program was supervised by a qualified physical therapist.
15770331|NCT04693104|Device|PVA Hydrogel|PVA Hydrogel will be supplied in 2 mL sterile and endotoxins-free pre-filled syringes containing a biocompatible polyvinyl alcohol crosslinked (PVA CL, main component) and buffered water for injections.
15770332|NCT04693104|Device|Synvisk-One®|Synvisc One® (comparator) will be supplied in a 6 mL sterile and non-pyrogenic syringe containing containing Hylan polymers (hylan A + hylan B) (main component), sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate monohydrate and water for injections.
15770333|NCT04693091|Device|Senti V1.0 Device|"This device class I, CE marked garment, with a similar form to a T-Shirt, embedded with ten sensor modules encased in silicone; the device comes with a charging stand in the form of a clothes hanger. Depending on the outcome of this feasibility study, the device may, in the future, form part of a class IIb medical device system, when accompanied by cloud-based software to listen to both current and historically recorded breath sounds for each Senti patient. The Senti Version One device will be labelled clearly to indicate the device version, on the inside of the garment, conforming to the MDR.
~The garment itself will be made from textile composite, including cotton, elastase, micromodel, spandex, and polyester. All other components (including electronic and other plastic components) will be entirely encased in medical-grade silicone."
15770334|NCT04693078|Device|AI polyp detection system based on deep learning|A Polyp detection system based on deep learning and artificial intelligence, which can alert the operator in real-time to the presence and location of polyps during a colonoscopy.
15770335|NCT04693065|Other|ponseti|Standard of care, treatment by ponseti method
15770336|NCT04693052|Other|No interventions|This is a self-reported survey study about receiving mental health care during the COVID-19 pandemic
15770337|NCT04693039|Drug|Phenlarmide|Dosage form：Tablet; Give the medicine once a day，4 weeks is a cycle of administration, a total of 3 cycles of administration.
15770338|NCT04693039|Drug|Placebo|Dosage form：Tablet; Give the medicine once a day，4 weeks is a cycle of administration, a total of 3 cycles of administration.
15770339|NCT04693026|Drug|Remdesivir|Remdesivir 100 IV Infusion as a lyophilized powder
15770340|NCT04693026|Drug|Baricitinib|Baricitinib oral tablet form
15770341|NCT04693026|Drug|Tocilizumab|Tocilizumab IV Infusion
15770342|NCT04693013|Device|Virtual Reality for Anxiety Reduction|Virtual Reality for Anxiety Reduction during suturing of perineum
15770344|NCT04692987|Other|Decision-aid video|Decision-aid video will be developed to disseminate knowledge and to raise awareness on colorectal cancer screening
15770345|NCT04692974|Device|Mobile phone application and smart watch|Mobile phone application prompts
15770346|NCT04692961|Device|Elastography|Use elastography to evaluate the stiffness of lower leg muscle after peroneal artery-based free flap harvested
15770347|NCT04692948|Other|Chimeric antigen receptor T cells (car-t)|Chimeric antigen receptor T cells (car-t) is one of the most effective therapies for malignant tumors (especially hematological tumors). Like other immunotherapies, the basic principle is to use the patient's own immune cells to clear cancer cells. Chimeric antigen receptor (car) is the core component of car-t, which endows T cells with the ability to recognize tumor antigens in an independent manner, which enables car modified T cells to recognize a wider range of targets than natural T cell surface receptors (TCR). The basic design of car includes a tumor associated antigen binding region (usually derived from scFv segment of monoclonal antibody antigen binding region), transmembrane region and intracellular signal region. The selection of target antigen is a key determinant for the specificity and effectiveness of car and the safety of genetically modified T cells.
15770348|NCT04692922|Diagnostic Test|MRI|MRI will include structural sequences (e.g., T1 weighted imaging, T2 weighted imaging, T2 FLAIR, diffusion weighted imaging with apparent diffusion coefficient, susceptibility weighted imaging, and diffusion tensor imaging). Using the structural sequences we will make note of the types of brain lesions (e.g., ischemic stroke, hemorrhage, hypoxic-ischemic brain injury), and the locations of these brain lesions. MRI will also include fMRI under three conditions: while the patient is at rest (to evaluate resting state functional connectivity), while the patient is exposed to auditory stimuli (to evaluate passive fMRI responses to stimuli), and while the patient is asked to follow commands (to evaluate active fMRI responses to tasks).
15770349|NCT04692922|Diagnostic Test|EEG|The EEG will include resting, stimulus-based, and task-based assessments of brain function.
15770350|NCT04692909|Device|dTMS with mPFC stimulation|dTMS with Brainsway's H7 device, stimulating the mPFC.
15770351|NCT04692896|Drug|lidocaine|different concentrations of lidocaine with same concentration of adrenaline
15770352|NCT04692883|Procedure|Percutaneous suturing|
15770353|NCT04692857|Procedure|supra inguinal fascia iliaca block|injection of 30,40 or 50 ml of 0.2 ropivacaine .
15770354|NCT04692844|Drug|Propranolol|Patients will receive Propranolol in the course of their routine treatment. Results will be used to explore biological phenomena or disease processes.
15770355|NCT04692844|Drug|Primidone|Patients will receive Primidone in the course of their routine treatment. Results will be used to explore biological phenomena or disease processes.
15770356|NCT04692831|Combination Product|89Zr-ss-pertuzumab PET/CT|Patients in Arm A will receive 89Zr-ss-pertuzumab first, followed by 89Zr-pertuzumab. Patients in Arm B will receive 89Zr-pertuzumab first, followed by 89Zr-ss-pertuzumab.
15770357|NCT04692831|Combination Product|89Zr-pertuzumab PET/CT|Patients in Arm A will receive 89Zr-ss-pertuzumab first, followed by 89Zr-pertuzumab. Patients in Arm B will receive 89Zr-pertuzumab first, followed by 89Zr-ss-pertuzumab.
15770358|NCT04692831|Diagnostic Test|Static PET/CT scans|89Zr-pertuzumab will be administered followed by 1 PET/CT scan 5-8 days post administration. For standard first in-human dosimetry, the first 6-8 patients who receive 89Zr-ss-pertuzumab will be followed by PET/CT imaging at 3 timepoints: 24 hours post administration (scan 1), 3-4 days post administration (scan 2) and 5-8 days post administration (scan 3). Once the optimal imaging timepoint for 89Zr-ss-pertuzumab is determined from these 6-8 patients, the remaining 12-14 participants will be scanned only at this optimal imaging timepoint.
15770359|NCT04692818|Diagnostic Test|GE Logiq E10 clinical ultrasound scanner|2D B-mode, Doppler, and shear wave elastography images of the lesion
15770360|NCT04692818|Diagnostic Test|Verasonics research scanner|3D B-mode imaging, microvessel imaging, and shear wave elastography
15770361|NCT04692805|Device|coils|EUS-guided injection of coils
15770362|NCT04692805|Drug|cyanoacrylate glue|EUS-guided injection of cyanoacrylate glue
15770363|NCT04692792|Dietary Supplement|Placebo drink|consume 1 bottle (50 mL) per day for 8 weeks
15770364|NCT04692792|Dietary Supplement|Dai Dai flower drink|consume 1 bottle (50 mL) per day for 8 weeks
15770365|NCT04692779|Other|Lung Ultrasound (LUS)|Enrolled subjects will undergo LUS 1 hour before and 1 hour after prone positioning by a trained clinician and will be assessed using a LUS score based on LUS pattern. LUS will then be performed again 1 hour before supination (16 hours) and assessed by a LUS score. This process will be repeated on the first 3 prone sessions. Patients will be enrolled in the study for 4 weeks in order to observe patient outcomes.
15770366|NCT04692766|Biological|RPH-104|solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL transparent glass vial
15770367|NCT04692766|Drug|Placebo|Normal Saline (0.9% Sodium Chloride solution for Injection), 5 mL in a polypropylene ampoule, 10 ampoules per labeled package
15770368|NCT04692753|Other|Training and education|Training and education of health care workers in the form of online seminars and bed side demonstration of care and maintenance of venous access devices
15770369|NCT04692740|Drug|Chlorambucil, Oral, 2 Mg|Eligible patients will be treated with Chlorambucil 6 mg/m2 daily p.o. for 42 consecutive days (weeks 1-6). After restaging, responder patients (complete or partial response) and those with stable disease will receive Chlorambucil 6 mg/m2 daily p.o for 14 consecutive days every 28 days until disease progression or unbearable toxicity, patient refusal or medical decision. Patients' clinical data will be collected pseudo-anonymously and a sequential identification code number will be assigned to each patient enrolled in the study.
15770370|NCT04692727|Other|Exercise program|"Hamstring, quadriceps, gastrocnemius, iliopsoas, iliotibial band (ITB), lateral and medial retinaculum stretching exercises
~Isometric exercises of vastus medialis, gluteus medius and external rotators
~Isotonic exercises of vastus medialis, gluteus medius and external rotators
~Closed kinetic chain exercises
~Balance and coordination exercises
~Core stabilization exercises"
15770371|NCT04692727|Other|McConnel patellar taping technique|Individuals are placed in a supine position with their knees extended and the quadriceps relaxed. A 5 cm wide hypoallergenic band is applied transversely over the patella without affecting the position of the patella. Then, it is started at the lateral edge of the patella with a rigid tape. The tape is terminated at the medial femoral condyle after a medial pull and / or medial tilt to the patella.
15770372|NCT04692727|Other|Femoral rotational taping technique|This technique is applied in a standing position and hip extreme external rotation. Taping is started on the vastus medialis and is pulled diagonally from the anterior of the leg to the lateral and ends on the trochanter major.
15770523|NCT04691388|Drug|Amlotinib+Sindili|All patients will receive Sindelizumab combined with Antinib Hydrochloride capsule every 3 weeks
15770373|NCT04692714|Device|Knee prosthesis implementation with additional cement|During surgery, a TRIATHLON prosthesis will be implemented with the MAKO robot with additional cement.
15770374|NCT04692714|Device|Knee prosthesis implementation without additional cement|During surgery, a TRIATHLON prosthesis will be implemented with the MAKO robot without additional cement.
15770375|NCT04692701|Device|Pulvinar deep brain stimulation|Stimulation of the medial pulvinar
15770376|NCT04692688|Drug|APX3330|APX3330, a small-molecule oral tablet, is a Ref-1 inhibitor that can potentially reduce proinflammatory and hypoxic signaling that contributes to several eye diseases.
15770377|NCT04692688|Drug|Placebo|Placebo tablets are identical to APX3330 tablets except for the absence of the active pharmaceutical ingredient.
15770379|NCT04692649|Other|pragmatic posterior capsular stretch|pragmatic posterior stretch is used to increase the length of the posterior capsule
15770380|NCT04692649|Other|cross body stretch|crossbody stretch performed by an individual
15770381|NCT04692636|Diagnostic Test|Measure: BP measurements, inter-dialysis BP variability, intra-dialysis hypotension|BP will be measured at the beginning and end of each dialysis session in a seated position by a trained dialysis nurse in accordance with the routine unit practice and entered into an electronic database. BP was measured using validated oscillometric BP monitor equipped in hemodialysis machines (Fresenius 4008S or Nikisso DBB-05), which were maintained as per dialysis unit protocols.
15770382|NCT04692623|Drug|Moxifloxacin 400mg|Blood will be checked for glucose levels at Baseline(Day Ist) and at Steady state Steady state(Tmax) via Glucometer and Insulin ELISA KIT will be used for determination of serum insulin levels.
15770383|NCT04692623|Drug|Gemifloxacin 320 MG|Blood will be checked for glucose levels at Baseline(Day Ist) and at Steady state(Tmax) via Glucometer and Insulin ELISA KIT will be used for determination of serum insulin levels.
15770384|NCT04692610|Behavioral|Stoma prehabilitation|A stoma pouch was attached to the marked stoma site on the patient's abdominal surface after stoma education (only in group C). EST nurse filled 250 ml water into the pouch. Patients lived with these pouches until surgery. They experienced walking, sitting, sleeping, changing clothes with a pouch. They learned how to empty it. When a leak occurred, the pouch was changed by the nurse
15770385|NCT04692610|Behavioral|preoperative stoma education|A consultation period for stoma education by an EST nurse was approximately 45 minutes. Patients were shown pictures of a stoma. The stoma-care equipments and a pouch were also shown to the patients and they were informed about these equipments. They were also provided information about daily living with a stoma.
15770386|NCT04692610|Behavioral|postoperative stoma education|A consultation period for stoma education by an EST nurse was approximately 45 minutes. Patients were shown pictures of a stoma. The stoma-care equipments and a pouch were also shown to the patients and they were informed about these equipments. They were also provided information about daily living with a stoma.
15770387|NCT04692610|Behavioral|Postoperative stoma care|Usual stoma care given by enterostomal therapy nurse after a surgery with fecal diversion
15770388|NCT04692597|Device|Phoenix Thera-Lase System|Low level laser therapy (LLLT) using Phoenix Thera-lase device (74 Watts, 1275 nm wavelength) for 6 minutes per affected hand.
15770389|NCT04692597|Device|SHAM Phoenix Thera-Lase System|Sham LLLT using the Phoenix Thera-lase device with the guide light on but without emitting laser photons for 6 minutes per affected hand.
15770390|NCT04692584|Behavioral|The Lullaby Group|"Approximately 15 seconds before the vaccination, each baby's mother began to sing a lullaby. The mothers stood approximately 30 cm from their babies and were allowed to touch their babies during the vaccination process. All the mothers sang the same lullaby, Sleep and Grow. This selection was determined by two different faculty members at a State University, Faculty of Education, Department of Fine Arts Education, Department of Music Education. Mothers were reminded of the words to the lullaby before vaccine administration."
15770391|NCT04692571|Device|PSICON Measurement Apparatus|Test apparatus acquires 16 sEMG channels, measure four DoFs of force/moment at the hand-wrist [hand open-close (Opn-Cls); wrist extension-flexion (Ext-Flx), radial-ulnar deviation (Rad-Uln) and pronation-supination (Pro-Sup)]. sEMG system used 16 custom encased bipolar electrodes. A commercial LTI EMG amplifier (BE328) conditioned each EMG signal before A/D conversion on a PC. A thermoplastic hand cuff secured the wrist to a six-axis load cell (AMTI, model MC3A-100) for force/moment measurement. A separate hand-grasp one-axis load cell (Omega Engineering Inc., model LCR-150) was Velcro-secured between the fingers and the thumb, to measure power grip forces. The PC acquired and stored the sEMG and load cell data, and commanded a triangular screen target. The subject controlled a second triangular cursor. Left-right movement of the cursor was controlled by wrist Ext-Flx, up-down movement by Rad-Uln deviation, cursor rotation by Pro-Sup and cursor size by hand Opn-Cls forces.
15770392|NCT04692558|Biological|HYALURONIC ACID|Hyaluronic acid will be applied on denuded root surface after reflection of isolated gingival recession.
15770393|NCT04692558|Procedure|coronally advanved flap with connective tissue harvesting|Coronally advanced flap surgery with connective tissue harvesting from palate
15770394|NCT04692545|Dietary Supplement|Immunonutrition|nutridrinks 3 times a day 5 days prior surgery plus maltodextrins the day of surgery
15770395|NCT04692532|Other|8-hour Time restricted eating|Ad libitum food intake from 12-8 pm every day Fasting from 8-12 pm every day (16-h fast)
15770396|NCT04692532|Other|Calorie restriction|25% energy restriction every day
15770397|NCT04692519|Behavioral|Duet Language Intervention Modules|The Duet 2.0 intervention modules promote the following guiding principles that help build effective communication. Below are the 5 principles covered in the six Duet modules: 1) General Awareness: Awareness and knowledge of child development 2) Creating Opportunities: Opportunities for communication during everyday activities 3) Conversational Duets: Rhythmic and reciprocal early language interactions 4) Scaffolding: Providing just enough help to support child independence 5) Harmonizing: Using the strategies together. These modules, which include behavioral strategies, real-life and animated examples of high-quality early language interactions, and interactive scenarios. The modules were informed and narrated by community members and carefully designed to address specific needs of high-risk communities. The modules have also been translated into Spanish, making sure to encompass specific cultural and dialect needs. Translation accuracy was verified by a qualified Spanish translator.
15770398|NCT04692506|Other|Probiotic|The study product is probiotic
15837116|NCT04147936|Dietary Supplement|Placebo|Placebo
15770401|NCT04692480|Behavioral|Breastfeeding Video Education|"Video entitled Breastfeeding in the First Hour, It's in Your Hands"
15770402|NCT04692480|Behavioral|Breastfeeding PDF education|PDF of standard breastfeeding education handouts
15770403|NCT04692467|Drug|Amlodipine 5mg|Amlodipine, Haiti's first-line antihypertensive medication, will be administered to the intervention group.
15770404|NCT04692454|Other|Modern acupuncture|use the scalp and ear acupuncture methods to identify diseases and checkpoints and apply them to regulate the immune function of patients with gastroenterological cancers.
15770405|NCT04692441|Dietary Supplement|Heavy Cream|100 ml of dairy cream with 40.4g of total fat, to ingest orally
15770406|NCT04692428|Procedure|Locoregional analgesia|the supra-inguinal fascia iliaca block versus the femoral nerve block
15770407|NCT04692415|Drug|Degludec|treatment of DM and it's affect on Glycaemic Variability, Oxidative Stress, Arterial Stiffness and the Lipid Profiles
15770408|NCT04692415|Drug|Glargine U300|treatment of DM and it's affect on Glycaemic Variability, Oxidative Stress, Arterial Stiffness and the Lipid Profiles
15770409|NCT04692402|Device|Solitaire™ thrombus retrieval device|After consent has been obtained, interventional cardiologist selects the proper solitaire device size per device-specific instructions for use. Adjunctive intervention with Solitaire will be done with a maximum of 2 device deployments. Do not perform more than three recovery attempts in the same vessel using the devices (Maximum of 2 attempts per device per subject). Do not reposition each device more than two times. TIMI flow, thrombus grade and myocardial blush grade will be assessed immediately upon completion of procedure. If recanalization is deemed inadequate by the interventional cardiologist, rescue treatment will follow as per current clinical practice. All other procedures followed will be as clinically indicated.
15770410|NCT04692389|Device|Jalosome soothing gel|This study has not got other intervention
15770411|NCT04692376|Biological|Mesenchymal stem cells|Mesenchymal stem cells (MSCs) will be intravenously infused via a central venous catheter(at a dose of 1×10^6 cells/kg, over 15 mins) weekly. MSCs will be administrated for 8 doses.
15770412|NCT04692376|Drug|Glucocorticoids|Glucocorticoids (i.e. Methylprednisolone) will be used with an initial dose of 1mg/kg.
15770413|NCT04692376|Drug|cyclosporine|Cyclosporine (CsA) will be used with an initial dose of 2.5mg/kg/d and adjusted according to the concentration of CsA. The targeted concentration is 200-300 ng/Ml.
15770414|NCT04692337|Procedure|Intra-operative Ommaya Reservoir placement|An Ommaya reservoir is a small device implanted under the scalp that enables percutaneous access to cerebrospinal fluid.
15770415|NCT04692324|Procedure|Cerebrospinal Fluid Collection|The optimal approach for CSF collection will be determined by the treating physician based on clinical judgement in discussion with the participant. CSF may be obtained during a clinically indicated surgery, via an existing device (such as a lumbar drain, Ventriculoperitoneal shunt, or Ommaya reservoir), by tapping a percutaneously-accessible CSF collection such as a pseudomeningocele if present, or by performing a lumbar puncture.
15770416|NCT04692311|Device|an intelligent client-centred task-oriented training|3 x 45min of training with i-ACT system
15770417|NCT04692311|Other|Semi-structured interview|Participants, patients and therapists, were invited to a semi-structured interview after training period.
15770418|NCT04692298|Other|pulses|kidney beans, pinto beans, lentil, black-eyed pea and chickpea
15770419|NCT04692285|Drug|Zolpidem|Patients will undergo transcranial magnetic stimulation, 18F-FDG-PET brain imaging, and clinical testing after a single 5 mg dose of Zolpidem.
15770420|NCT04692285|Drug|Placebo|Patients will undergo transcranial magnetic stimulation, 18F-FDG-PET brain imaging, and clinical testing after a single dose of placebo.
15770421|NCT04692272|Behavioral|Exercise in the XBOX kinect|"The XBOX group performed exercise for 60 min, three times/week, for 6 weeks, using the Xbox Kinect game Your Shape Fitness evolved. This game was chosen because it simulates an environment with a variety of physical activities, in which the majority can be practiced by older adults. The activities were carried out individually. The game activities selected for the physical activity sessions were: 1) Zen-Develop it (stretching, balance and flexibility activities, similar to Yoga); 2) Pump it (to fill balls until they burst); 3) Wall Breaker (to break blocks, similar to boxing); 4) Kick it (soccer activity); 5) Hurricane (to lift the balls off the floor and not let them fall); 6) Stack in Up (balance activity)."
15770422|NCT04692259|Diagnostic Test|MRI|Liver MRI before liver resection
15770423|NCT04692246|Other|Plant-based oral rinse|Oral rinse enriched with plant-based essential oils.
15770424|NCT04692246|Other|Placebo oral rinse|Oral rinse with the exact characteristics in terms of colour and odour of the plant-based one, but without the essential oils aimed to test in this study
15770425|NCT04692233|Behavioral|Qigong Baduanjin|Qigong Baduanjin will comprise eight standardized movements. It is practiced as a combination of body movements, breath control, and mindful meditation, which is designed to improve qi function.
15770426|NCT04692233|Behavioral|Light flexibility exercise|Each session will include seated and standing stretches that target upper (neck, arms, upper back, shoulders, back, and chest) and lower body (quadriceps, hamstrings, calves, and hips), as well as trunk rotations.
15770428|NCT04692181|Biological|SYN-004, Ribaxamase or Placebo|SYN-004 is an oral formulation of a recombinant class-A beta-lactamase that hydrolyzes the beta-lactam ring of susceptible antibiotics that are excreted into the intestines
15770429|NCT04692155|Drug|Ublituximab|Ublituximab (900mg) will be administered as an intravenous infusion through a dedicated line.
15770430|NCT04692155|Drug|Umbralisib|Umbralisib(800mg)will be administered orally once daily within 30 minutes of starting a meal.
15770464|NCT04691882|Behavioral|Diaphragmatic contraction|Sequential periods (30 s) of voluntary diaphragmatic contraction after meal ingestion
15770465|NCT04691882|Behavioral|Diaphagmatic relaxation|Sequential periods (30 s) of voluntary diaphragmatic relaxation after meal ingestion
15770466|NCT04691869|Device|Achilles EXPII|Portable ultrasound machine that measures a patient's bone density at the calcaneus.
15770431|NCT04692142|Other|Flipped classroom teaching method|Participants will have 7 -day monitored remote access to a recorded lecture about orthodontic topic. At the expiry of remote access to the recorded lecture, participants from FG will be invited to attend post-lecture discussion sessions. To enhance the effectiveness of flipped classroom teaching method, the cohort of FG will be randomly, using computer generated randomisation, subdivided to two smaller groups in which each group will be consisted of half of the FG cohort. The same lecturer will moderate the discussions for each group separately.
15770432|NCT04692116|Device|ExAblate treatment|Subthalamotomy using the ExAblate
15770440|NCT04692090|Other|Yoga|"Each class started with a check-in period during which any questions or concerns could be raised, after which the patients were given 5 minutes for seated meditation and 10 minutes for Shavasana (lying down in a restorative position).
~The following poses were instructed during the course: standing poses with mountain pose (tadasana), chair pose (utkatasana), extended triangle pose (utthita trikonasana), extended side angle pose (utthita parshvakonasana), warrior 1 (virabhadrasana 1), warrior 2 (virabhadrasana 2) and tree pose (vrikshasana). The intervention was applied twice a week for 10 weeks."
15770441|NCT04692077|Drug|Cabotegravir (CAB) tablet|30 mg tablets
15770442|NCT04692077|Drug|CAB LA|Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter.
15770443|NCT04692077|Drug|Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) tablet|300 mg/200 mg fixed-dose combination tablets
15770444|NCT04692064|Other|There is no intervention|There is no intervention
15770445|NCT04692051|Drug|Nab-paclitaxel + Cisplatin|Nab-paclitaxel 125mg/m2 IV on D1,8 plus Cisplatin 75mg/m2 IV on D1 , every 21 days.
15770446|NCT04692051|Drug|Gemcitabine + Cisplatin|Gemcitabine1000mg/m2 IV on D1,8 plus Cisplatin 75mg/m2 IV on D1 , every 21 days.
15770447|NCT04692038|Device|Forceps biopsy combined with puncture biopsy under the guidance of Augmented Reality Navigation and Radial EBUS|During the operation, under the guidance of Augmented Reality Navigation, the bronchoscope will reach the location of the target pulmonary nodules, and the EBUS probe will be inserted through the bronchoscope working channel, and gradually approach the target nodules to obtain EBUS images. After typical EBUS images are observed and the location is confirmed, the EBUS probe will be withdrawn and biopsy forceps and puncture biopsy needle will be used to obtain samples at the target locations respectively.
15770448|NCT04692025|Drug|ASC41 tablet|Oral tablet
15770449|NCT04692012|Other|FRESH CORNEAL MYOPIC LENTICULE IMPLANTATION|VisuMax femtosecond laser performed flap-cut procedure with an energy cut index of 30 nJ (150nJ), spot and track spacing surface cut of 4.5 μm, side cut 2.0 μm were used to create an intrastromal pocket into the patient's cornea to receive the donor lenticule. The stromal pocket diameter was set 7.6 to 8.0 mm (1 mm larger than the optical zone of the donor lenticule) and cap thickness was set to 130 μm from corneal surface and a 4 mm superior incision. Hinge position flap was set at 90°, angle 50° and width 4 mm, side cut angle 90°. The pocket was dissected using a blunt spatula washed with normal saline. The lenticule was held with lenticule forceps and gently inserted into the pocket through the 4 mm superior incision. Incision position changed according to the position of the highest K values. Current orientation was marked with a sterile skin marker. The lenticule was positioned around the marked center of the cone and flattened out from the surface using a blunt spatula.
15770450|NCT04691999|Behavioral|Intermittent Fasting|16-18 hour fasting period four times per week
15770453|NCT04691973|Behavioral|Health and lifestyle tool|Health and lifestyle tool used online
15770454|NCT04691973|Other|Usual care|Usual care at ordinary healthcare provider
15770455|NCT04691960|Other|Ketogenic Diet|Ketogenic diet is high-fat, low carbohydrate diet. Ketogenic diet will be maintained on a continuous basis. The diet will begin at an approximately 3:1 fat to carbohydrate + protein ratio for 5 days. If the patient does not show urine ketosis (1.5 mmol/L or 27.0 mg/dL), the ketosis diet will be advanced to approximately 4:1 ratio for 5 days. If the patient still does not attain ketosis a 24 hour fast will be done to promote ketosis. The diet will encourage at least 30 ml per day of Medium Chain Triglycerides (MCT) oil to enhance ketosis.
15770456|NCT04691960|Drug|Metformin|Metformin will be administered as a single 850 mg dose P.O. at Week 8, then titrated up to 850 mg P.O. BID at Week 10, and then 850 mg T.I.D. at Week 12, as tolerated.
15770457|NCT04691947|Biological|ERUCOV-VAC|Vaccination on Day 0 and Day 21
15770458|NCT04691947|Other|Placebo Vaccine|Placebo Vaccination on Day 0 and Day 21
15770459|NCT04691934|Procedure|Anesthesia management|Patients who underwent cesarean section and had positive PCR nasopharyngeal swabs for COVID-19 were included in the study. Patients who tested negative and were clinically suspicious were excluded from the study. PCR test was not performed on all elective and emergency pregnant women to be taken for cesarean section in our hospital. It was only applied to patients with symptoms or patients who were suspected. All patient demographics and information about anesthesia were analyzed retrospectively from the patient files.
15770460|NCT04691921|Behavioral|Current clinical practices of participating physicians|Current clinical practice of participating physicians on choice of pharmacological agents for clinical management of Severe COVID-19
15770461|NCT04691908|Biological|QazCovid-in®-vaccine against COVID-19|QazCovid-in® (inactivated) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan
15770462|NCT04691908|Other|Placebo|Placebo (sodium chloride buffs, solvent for the preparation of dosage forms for injection 0.9%)
15770463|NCT04691895|Other|SARS-CoV2 infection|Confirmed COVID19 cases The definitions of COVID19 state are according to the WHO document released in March 2020. A person with laboratory confirmation of COVID-19 infection, irrespective of clinical signs and symptoms.
15770467|NCT04691856|Drug|Morphine Sulfate|Patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
15770468|NCT04691856|Drug|Intravenous paracetamol|1 g paracetamol will be administered 30 minutes before the end of surgery. All administrations will be applied through IV infusion over 30 minutes. Patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
15770469|NCT04691856|Drug|Intravenous ibuprofen|800 mg ibuprofen (diluted with 250 ml saline) will be administered 30 minutes before the end of surgery. All administrations will be applied through IV infusion over 30 minutes. Patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
15770470|NCT04691856|Drug|Morphine|All patients were instructed to use intravenous patient-controlled analgesia (IV PCA). All administrations will be applied through IV infusion over 30 minutes. Patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
15770471|NCT04691843|Drug|Iron Sulfate|Early, high dose, iron supplementation
15770472|NCT04691830|Behavioral|Prosody treatment program|"The prosody treatment program is an evidence-based practice targeting receptive and expressive prosodic skills in addition to speech production, intelligibility, pragmatics and phonology. The program incorporates the principles of validated prosodic rehabilitation strategies such as Dynamic Temporal and Tactile Cueing (DTTC), Melodic Intonation Therapy, Lee Silverman Voice Treatment in addition to expert professional practice.
~The program was applied using a systematic approach of providing cues to help accelerate the child's learning of the prosodic skills targeted in the program. The program is divided into two sections according to the age into preschool section and school age section."
15770473|NCT04691830|Behavioral|Traditional auditory and language rehabilitation|Auditory rehabilitation therapy included activities targeting auditory skills: sound detection, discrimination, identification and auditory comprehension. Language rehabilitation targeted improving semantics, syntax, pragmatics and phonology.
15770474|NCT04691817|Drug|Atezolizumab|1200mg infusion
15770475|NCT04691817|Drug|Tocilizumab|Tocilizumab 6mg/kg or 4mg/kg infusion
15770476|NCT04691804|Drug|Fuzuloparib , Abiraterone acetate and Prednisone|"Fuzuloparib capsules (strength: 50 mg),150mg, Bid,po
~Abiraterone acetate tablets (strength: 250 mg) 1000mg Qd,po
~Prednisone tablets (strength: 5 mg) 5mg, Bid po"
15770477|NCT04691804|Drug|Fuzuloparib Placebo， Abiraterone acetate and Prednisone|"Fuzuloparib capsules Placebo (strength: 50 mg),150mg, Bid,po
~Abiraterone acetate tablets (strength: 250 mg)1000mg Qd,po
~Prednisone tablets (strength: 5 mg)5mg, Bid po"
15770478|NCT04691778|Procedure|CTO PCI with the first-choice Gladius guidewire|CTO PCI using antegrade wiring strategy with the first-choice Gladius guidewire
15770479|NCT04691778|Procedure|CTO PCI without the first-choice Gladius guidewire|CTO PCI using standard antegrade wire escalation strategy
15770480|NCT04691765|Drug|Kineret|escalating doses of drug will be administered to 3 groups of 4 patients for 7 months
15770481|NCT04691752|Other|Audit|Audit from clinical records
15770482|NCT04691739|Other|occupational therapy|occupational therapy sessions include a set of standardized test exercises plus additional modalities that are optimized to each patient's needs according to the clinical judgement of the treating therapist
15770483|NCT04691726|Drug|lidocaine 10mg/ml|bolus i.v. + continuous i.v. infusion
15770484|NCT04691726|Drug|Placebo|bolus i.v. + continuous i.v. infusion
15770485|NCT04691726|Drug|Metamizole|2,5 g i.v. BD
15770486|NCT04691726|Drug|Morphine|continuous i.v. infusion adjusted to VAS scale score
15770487|NCT04691713|Drug|Targeting CD276 autologous chimeric antigen receptor T cells|Chimeric antigen receptor T cells (car-t) is one of the most effective therapies for malignant tumors (especially hematological tumors). Like other immunotherapies, the basic principle is to use the patient's own immune cells to clear cancer cells. Chimeric antigen receptor (car) is the core component of car-t, which endows T cells with the ability to recognize tumor antigens in an independent manner, which enables car modified T cells to recognize a wider range of targets than natural T cell surface receptors (TCR). The basic design of car includes a tumor associated antigen binding region (usually derived from scFv segment of monoclonal antibody antigen binding region), transmembrane region and intracellular signal region. The selection of target antigen is a key determinant for the specificity and effectiveness of car and the safety of genetically modified T cells.
15770488|NCT04691700|Drug|Goreisan|Add Goreisan 7.5g per day to standard treatment with the intention to reduce or discontinue the existing diuretics
15770489|NCT04691700|Drug|Standard Treatment|Standard therapy without Goreisan
15770490|NCT04691687|Drug|Furosemide|IV loop diuretic therapy
15770491|NCT04691687|Drug|IV Solution|IV Placebo comparator
15770492|NCT04691674|Procedure|Endoscopy|Endoscopic removal of the pancreatic stent
15770493|NCT04691661|Drug|Radotinib HCl 50 mg|Enrolled subject will continue to administer Radotinib 50mg/day, 100mg/day, 150mg/day, 200mg/day, depending on the dose level once daily for 6 months.
15770494|NCT04691661|Drug|Placebo|Placebo
15770496|NCT04691635|Other|evaluation of movements with sensors|evaluation of movements with sensors
15770497|NCT04691622|Biological|Norovirus -specific T-cell (NST) therapy|"Arm A: Investigators will test three doses: 1 x 107 /m2, 2 x 107 /m2, and 4 x 107 /m2. After infusion, participants will have a 45-day safety monitoring period for immediate toxicities following infusion.
~Arm B: Investigators will test three doses: 1 x 107 /m2, 2 x 107 /m2, and 4 x 107 /m2. After infusion, participants will have a 45-day safety monitoring period for immediate toxicities following infusion."
15770498|NCT04691596|Behavioral|Non-cue-contingent weekly incentives|Eligible to win $5 Amazon gift card conditional on completing a daily ≥10-minute walk at any time of day
15770524|NCT04691375|Drug|PY314|Dose of PY314 as a single agent given in a standard 3+3 design.
15770499|NCT04691596|Behavioral|Cue-contingent weekly incentives|Eligible to win $5 Amazon gift card conditional on completing a daily ≥10-minute walk within a +/-1 hour window of the pre-specified time of their chosen contextual walking cue
15770500|NCT04691596|Behavioral|Habit Coaching|Received an instructional video on the benefits of contextual-cue-dependent habits and instructions on how to identify an optimal personalized cue that would consistently trigger their ≥10-minute walking habit
15770501|NCT04691596|Behavioral|App use instructions|Received a basic training with the StepUp app
15770502|NCT04691583|Other|Fast diet|"Fast diet of High control ：From May 24, 2018, the method of fast diet was adopted on alternate days. According to the dietary records of normal diet, the normal caloric intake of each subject was calculated. Fast diet was carried out according to 2/3, 1/2, 1/3 and 1/4 of the original normal caloric intake.Each caloric stage last for 4 days, and the total cycle of fast diet was 31 days.
~Fast diet of Low control ：After the intervention of fast diet of high control, the subjects were allowed to continue the diet fast diet every other day. It was suggested that the daily caloric intake was 600kal/ day for males and 500kal/ day for females."
15770503|NCT04691570|Drug|ANX005|ANX005 is provided as a solution for IV infusion
15770504|NCT04691557|Other|Mobile Health Application|AST-M is designed as an adolescent-focused, interesting, creative, useful, provide unlimited and unimpeded access to information resources, mobile interfaces that can be individualized and enable self-learning, connect in-depth information enriched with much visual content and a communication channel with healthcare professional that they can consult whenever they wish. Also content of the app is based on Social Cognitive Theory (Bandura, 1986)
15770505|NCT04691557|Other|Usual Care|Adolescents in the control group, an asthma training covering also individualized specific conditions is provided by education nurses for 15-30 minutes in the nursing room of the outpatient clinic for all children. In this training with adolescents, video and visual materials included in the routine of the outpatient clinic for the use of devices and drugs are used.
15770506|NCT04691544|Biological|Fecal microbiota transplantation (FMT)|Delivered by enema
15770507|NCT04691531|Device|The use of classical Gauge 22 needle|After induction of general anesthesia, patients will undergo caudal block by using classical Gauge 22 needle under ultrasound guidance using a linear probe 5.5-12 MHz.
15770508|NCT04691531|Device|The use of classical Gauge 27 needle|After induction of general anesthesia, patients will undergo caudal block by using Gauge 27 needle under ultrasound guidance using a linear probe 5.5-12 MHz.
15770509|NCT04691518|Other|Acute Intermittent Hypoxia|30 minute session of Acute Intermittent Hypoxia
15770510|NCT04691518|Other|Sham Acute Intermittent Hypoxia|30 minute session of Sham Acute Intermittent Hypoxia
15770511|NCT04691505|Drug|Methotrexate|Methotrexate is used as the reference group.
15770512|NCT04691505|Drug|Hydroxychloroquine|Hydroxychloroquine is used as the exposure group.
15770513|NCT04691492|Behavioral|Friend-Based Motivational Interview|The intervention will use Motivational Interviewing's (MI) collaborative conversation style for strengthening commitment to change, to motivate and prepare women to work together to reduce Sexual Assault (SA) risk. This intervention will target ways that the friend dyad may support, encourage, and share responsibility with one another in protecting against SA. The Friend-based MI (FMI) will then use the responsibility and relationship of friends as a framework to foster collaborative efforts to increase readiness and decrease barriers to helping behavior. As part of this, the FMI will focus on the identification and implementation of skills friends can use to help one another prevent sexual assault. FMI will include a focused discussion of the ways drinking may impede helping efforts. Moreover, the FMI will encourage women to identify personal, specific strategies for reducing the effects of alcohol on helping.
15770514|NCT04691479|Behavioral|Motivational Interview (MI) & Adherence Follow-Up|"MEntA: Educational & Training Program
~Stratification: Identification of Personal Variables (Age, Level of study, Work status, preference of care attention, digital behaviour)
~Adherence evaluation: Evaluation of Perceived Competence, Quality of Life, Mood, Activities, Social relations and Social Support
~Identification of Care plan and Schedule next visits
~Follow-up D30-D60-D90-D180 depending of the care plan, through the channel that belong for each care plan"
15770515|NCT04691479|Behavioral|Adherence Follow-Up|The nurse takes the compliance of the CPAP device, and ask to the patient if he had some problems.
15770516|NCT04691466|Procedure|Joint replacement|Routinely performed hip- or knee replacement
15770517|NCT04691453|Procedure|QM-C Hysterectomy|This operation corresponds to the classical radical hysterectomy. The lateral border is defined as the medial aspect of the internal iliac artery and vein. Transection of the rectovaginal and rectouterine ligaments is performed at the rectum. Transection of the ventral parametrium ligament is performed at the bladder. Both the vesicouterine and vesicovaginal ligaments are resected. The ureter is completely mobilized and lateralized. The length of the vaginal cuff is adjusted to the vaginal extent of the tumor.
15770518|NCT04691453|Procedure|QM-B Hysterectomy|Type B is the modified radical hysterectomy. The ureter is unroofed and mobilized laterally, permitting transection of the paracervix at the level of the ureteral tunnel. Partial resection of the uterosacral peritoneal fold of the rectouterine ligament (dorsal parametrium) and the vesicouterine (ventral parametrium) ligament also is a standard component of this resection. Approximately 10 mm of the vagina from the caudal edge of the cervix or tumor is resected, without intent to radically resect the paravaginal tissues.
15770519|NCT04691440|Drug|Hyperbaric oxygen|The course of hyperbaric oxygen treatment comprises a total of 6 pressure exposures, distributed 2 times daily, for 3 days.
15770521|NCT04691414|Genetic|NGS|next-generation sequencing on preexisting samples
15770522|NCT04691401|Device|Artificial Intelligence System (CAD EYE, Fujifilm Co.)|A dedicated CNN-based AI system (CAD EYE, Fujifilm Co, Tokyo, Japan) has been recently developed. The Computer-aided diagnosis (CAD) CAD EYE system is a real-time computer-assisted image analysis that allows automatic polyp identification without modifications to the colonoscope or to the actual endoscopic procedure. When CAD EYE identifies a polyp, both a visual (a green blinking box surrounding the identified polyp, called the detection box) and an acoustic alarm pop up and attract the endoscopist attention. Around the endoscopic image a visual assist circle is shown and lights up in the direction where the suspicious polyp is detected.
15770525|NCT04691375|Drug|Combination Therapy: PY314 + Pembrolizumab|Dose of PY314 alone and given in combination with pembrolizumab
15770526|NCT04691362|Drug|Tranexamic Acid Oral Product|Oral administration of 2 grammes tranexamic acid 2 hours before skin incision and 2 grammes oral tranexamic acid 4 hours after first administration
15770527|NCT04691362|Drug|Tranexamic acid injection|Intravenous administration of 1 gramme tranexamic acid 30 minutes before skin incision and 1 gramme intravenous tranexamic acid 4 hours after first administration
15770528|NCT04691349|Drug|CAR-T|The basic design of car includes a tumor associated antigen binding region (usually derived from scFv segment of monoclonal antibody antigen binding region), transmembrane region and intracellular signal region.
15770529|NCT04691336|Behavioral|Educational and Training with counselling|The nurse conducts a structured interview that covers the following areas: information on respiratory attraction and the symptom of dyspnea, expectations and beliefs about oxygen therapy, use of oxygen therapy, healthy habits, social support. It also evaluates the patient's perception of oxygen therapy, and the level of dyspnea using the mMRC scale. After this, the nurse evaluates the current level of adherence, and if she considers that the patient needs a reinforcement session, she schedules a workshop with 3 other patients and their main caregivers. This workshop takes place 30 days after this interview. In other patients, depending on the level of adherence, a support call is made, and all patients are visited again at the center at 90 days, performing the same evaluation with a structured interview and the scales that were made on day 1
15770530|NCT04691323|Other|HU-Go app|A novel multifunctional mobile app (HU-Go) to improve adherence to hydroxyurea in patients with sickle cell disease
15770531|NCT04691310|Device|Kinesio Tex Gold|The Kinesio Tex Gold is a kinesio tape that had been certified and patented.
15770532|NCT04691297|Other|Escape|The ESCAPE intervention consists of five components:1) behavioral counseling, 2) the use of NRT, 3) digital SNC 4) decision aid about LDCT screening, and 5) a letter and educational materials sent to the primary care provider.
15770533|NCT04691297|Other|Standard Care|Participants in the standard care arm (brief advice and referral to quit line), will be referred to the MA Quitline which provides free NRT by the study team and will receive an educational brochure related to lung cancer screening.
15770534|NCT04691284|Other|Blood, urine and stool sampling|Sampling of blood and urine for miR and chemokine detection. Sampling of stool for for microbiome studies.
15770535|NCT04691271|Procedure|Stellate ganglion block|After the patient entered the operating room, the average fastest blood flow velocity of the bilateral middle cerebral arteries was measured for the first time, and then an experienced anesthesiologist performed a SGB on the ipsilateral side of the lesion. The dose and concentration of local anesthesia: 0.5% ropivacaine 8-10ml. In order to reduce puncture complications, B-ultrasound visualization technology was used to perform SG block. Criteria for successful block: the patient developed Horner's syndrome, characterized by miosis, ptosis, eyeball caved in, nasal congestion, conjunctival congestion, reddish face and no sweat on the face
15770536|NCT04691258|Behavioral|Experimental: Complete Group|"The participants performed the squat and Stiff exercises with the maximum range of motion. In the squats, the knees were completely flirted, even if the participant could not perform the movement with neutral vertebral posture. The heels were also not supported to the ground in some participants due to lack of flexibility. It was instructed that the participants tried to perform the Squats and Stiff keeping the lumbar lordosis neutral, with the best posture they could in all training sessions, but all should perform the exercise with as much range of motion as possible.
~The positioning of the feet was also carefully controlled, there was no hip rotation and the distance between the lateral edges of the heels was defined as the distance between the upper iliac spines (EIAS). The direction of the knees was oriented pointing in the direction of the tip of the feet parallel throughout the cycle of the movement."
15770537|NCT04691258|Behavioral|Active Comparator: Restricted Group|"The conventional movement technique of the squat exercise was used, in which the participants performed with the range of motion restricted to the neutral vertebral posture, approximately 90º of movement of the knee joint. may increase the range of motion if the lumbar posture did not rectify.
~The positioning of the feet in this group was carefully controlled, the participants performed the exercise with the joints of the hips abducted and rotated laterally. Having markings on the ground as a reference, the feet went rotated at 21º and the lateral edge of the heels were moved away from each other, approximately with the biacromial distance. The direction of the knees was oriented pointing in the direction of the tip of the feet throughout the cycle of the movement, aligned to the lateral rotation of the hip. In the first training session, with the aid of a goniometer and metric tape, adhesive marks were placed on the floor to ensure this positioning of the support base."
15770538|NCT04691245|Device|3D US|3D US guided access to femoral artery
15770539|NCT04691245|Device|2D US|2D US guided access to femoral artery
15770540|NCT04691232|Biological|Regulatory T cells|Autologous, ex vivo expanded, regulatory T cells
15770541|NCT04691219|Dietary Supplement|Mulberry leaves powder|Dried powder of mulberry leaves crude extract containing 12 mg of DNJ will be packed in a sealed packet with light and moisture protection. Participants will be instructed to mix 1 packet of the powder with a half glass (approximately 120 mL) of plain water and ingest thrice daily before meals. Additionally, they will be informed to rinse the glass with more water and drink to ensure that all of the powder will be taken.
15770542|NCT04691219|Behavioral|Diet control|Participants will be requested for diet control. They will be asked for attending the diet control program, maintaining diet pattern throughout the study period, and recording a 3-day food record. Individual counseling and assessment of compliance will be performed by licensed dietitians every 4 weeks. Diet control is principally based on carbohydrate counting.
15770543|NCT04691206|Other|briefing objectives, intraoperative teaching, and debriefing feedback|A standardized step-wise operative curriculum amongst general surgeons will be implemented among all general surgery residents. Residents will follow and graduate through this curriculum by initiating a perioperative model of briefing objectives, intraoperative teaching, and debriefing feedback (BID).
15770544|NCT04691180|Drug|BRII-196 and BRII-198|BRII-196 and BRII-198 given intravenously
15770545|NCT04691180|Drug|Placebo|Placebo given intravenously
15770546|NCT04691167|Device|repetitive trans magnetic stimulation|Repetitive Trans-cranial Magnetic Stimulation (rTMS) is a relatively safe and non-invasive method to modulate neuronal activity; rTMS uses alternating magnetic fields in a certain frequency to induce an electric current in the underlying brain tissue.
15770547|NCT04691154|Combination Product|L606 inhalation suspension|L606 inhalation suspension, twice daily dosing
15770548|NCT04691141|Drug|ATG-016|59 patients enrolled will be treated with 5 mg (QD×Days 1-5/week), orally, each 4 week (28-day) a cycle
15770551|NCT04691115|Drug|AM1476 - Placebo|Oral drug administration
15770552|NCT04691076|Drug|Propofol|Propofol is administered by target-controlled infusion
15770553|NCT04691076|Drug|Esketamine|Esketamine is intravenously administrated
15770554|NCT04691076|Drug|Fentanyl|Fentanyl is intravenously administrated
15770555|NCT04691063|Drug|SHR-1316; Carboplatin; Etoposide；Radiotherapy|SHR-1316; Carboplatin; Etoposide；Radiotherapy（Part 1 and Part 2）
15770556|NCT04691063|Drug|Palcebo; Carboplatin; Etoposide；Radiotherapy|Palcebo; Carboplatin; Etoposide；Radiotherapy（Part 2）
15770557|NCT04691050|Procedure|OrthoMTA (BioMTA)|Primary second molars without successors in which traditional root canal treatment with gutta-percha could not be performed was treated with OrthoMTA
15770558|NCT04691037|Diagnostic Test|CCTA|All patients underwent CCTA according to established guidelines and local institutional protocols. The imaging data were evaluated using different image post-processing software to comprehensively analyse anatomical, functional and histological information of coronary.
15770559|NCT04691024|Other|Exercise|Spinal stabilization exercises
15770560|NCT04691011|Other|Muscular MRI|MRI (1.5T)
15770561|NCT04691011|Other|Electrophysiological exam|MUNIX
15770562|NCT04691011|Other|Brain MRI|MRI (7T)
15770563|NCT04691011|Other|Spinal cord MRI|7T and 3T MRI
15770564|NCT04690998|Other|Blood Samples|Genetic, proteomic, neurofilament analysis
15770565|NCT04690998|Other|MRI|Spinal and muscular MRI
15770566|NCT04690985|Behavioral|Dietary behaviour change|The intervention consists of dietary guidance and behaviour change techniques, which will last for 15 weeks. The experimental group will be required to adhere to a diet consisting of a 12% reduction in calorie and a 1.2-1.5 g/kg body weight/day intake of protein. The participants will receive the dietary behaviour change guidance in 6 times face-to-face meetings and weekly telephone calls. They will also be asked to take daily food diary.
15770567|NCT04690985|Other|Social contact|The control group will not be required any dietary changes. The investigator will contact with the control group with the same frequency and numbers of experimental group. But the chat topic will not be related to sarcopenic obesity or dietary guidance.
15770568|NCT04690972|Procedure|Blood sample during surgery|During the hepato-bilio-pancreatic surgery, blood is drawn.
15770569|NCT04690972|Procedure|Taking an additional biopsy|As part of the treatment, an additional biopsy is executed and blood is drawn.
15770570|NCT04690972|Diagnostic Test|Blood sample during diagnostic test|Blood sample as part of the care
15770571|NCT04690959|Other|neural mobilization|Neural mobilization, or neurodynamics, is a movement-based intervention aimed at restoring the homeostasis in and around the nervous system.
15770572|NCT04690959|Other|Sham intervention|it is faked neural mobilization that mimic the neural mobilization treatment but believed not to stress the neural tissues in the upper extremity.
15770573|NCT04690946|Behavioral|Cognitive Behavioral Therapy|14-18 sessions of CBT
15770574|NCT04690946|Behavioral|Emotion-Focused Therapy|14-18 sessions of EFT
15770575|NCT04690933|Other|Real-life observatory of efficacy and resistance to anti CMV molecules in stem cell recipients|Signing of consent at the time of the pre-transplant consultation (1 month before grafting). Inclusion of patients during conditioning (around D-8 of transplantation). Samples related to the cohort:one blood sample from the donor (only familial donors) for genetic SNPs analysis. 5 samples: D-8, D20, D100, D200 (+/-10 days), 1 year : 1 tube of 7ml of whole blood on EDTA: Biobanking of whole blood for genetic SNPs analysis (D-8) of specific transporters for GCV, and of plasma for TTV viral load at all times. In routine care:samples taken in the event of a therapeutic escape (2 x 7 ml EDTA tubes, for resistance genotype, and ganciclovir dosage, 3 x 1 ml for Quantiferon CMV, according to CNR Herpesvirus recommendations. 1 x Paxgene tube (2.5 ml) for subsequent CMV genomic and transcriptomic studies. Cell preservation plasma and whole blood for biocollection (2 tubes EDTA de 7ml). Samples stored by the centers' virology laboratories are periodically sent to the CNR for analysis.
15770576|NCT04690920|Drug|Tocilizumab|Comparison of drugs, Tocilizumab, Remdesivir, standard treatment with controls
15770577|NCT04690907|Behavioral|Dietary intervention|Written material on healthy diet during pregnancy and 2 virtual dietary counseling sessions.
15770578|NCT04690894|Procedure|erector spinae block - caudal block|the child placed in lateral position identification of spinous process of 10th thoracic vertebral then the transducer was moved 2.5 cm laterally to visualize the transverse process and a total of 0.4mg/kg of 0.25%bupivacaine was adminstered
15770579|NCT04690881|Behavioral|Psychodrama group psychotherapy|In order to reduce the fear of cihildbirth, pregnant women are given 90 minutes right after the training in addition to the routine pregnancy training. In the psychodrama-based pregnancy education program, fear of childbirth were assesment by sociometric measurement in order to increase the awareness of pregnant women about birth fear levels in the first week. Afterwards, they were given the opportunity to express themselves about the factors that may cause fear in pregnant women (their previous traumatic experiences, negative prejudices about childbirth, etc). The group members shared about their process in the first session and the session was ended. The session was evaluated with other researchers. In the following sessions, in order to strengthen their coping with the fear of childbirth, besides psychodrama warm-up games, the basic techniques of psychodrama, role switching, matching and mirror were used in protogonist works.
15770580|NCT04690868|Drug|AD-213-A|1 tablet administered before the breakfast during 5 days
15770581|NCT04690868|Drug|AD-2131|1 tablet administered before the breakfast during 5 days
15770582|NCT04690855|Drug|Talazoparib|Talazoparib 1 mg Orally Day 1 to Day 28
15770583|NCT04690855|Drug|Atezolizumab|Atezolizumab 840 mg IV over 60 minutes Day 15 of Cycle 1 then Day 1 and Day 15 of subsequent Cycles
15770584|NCT04690855|Radiation|Radiation|Radiation 8 Gy will be given in 3 fractions QOD beginning Day 12, 13 or 14 of Cycle 1 but 24-72 hours prior to 1st dose of Atezolizumab
15770585|NCT04690842|Diagnostic Test|PTH measurements post-thyroidectomy (at 5 and 60 min post thyroid removal)|We implement an algorithm employing PTH levels post-thyroidectomy to stratify patients according to their postsurgical risk for hypoparathyroidism, and to distinctively manage them in the immediate postsurgical period. High risk patients are quickly supplemented with Calcium iv and activated 25OH vitamin D. Low risk patients are clinically controlled and calcium level were checked at 24 and 48 hs post thyroidectomy.
15770586|NCT04690803|Drug|air cooling|intervention is adding air-cooling to treatment
15770587|NCT04690790|Procedure|Thoracoscopy|Patients who are indicated for thoracoscopic nodulectomy.
15770588|NCT04690777|Procedure|Experimental: VESTIBULAR EXERCISE|OCULAR AND MOVEMENT EXERCISES
15770589|NCT04690777|Procedure|MULTICOMPONENT EXERCISE|exercises includes strengthening, cardiovascular training, flexibility and balance
15770590|NCT04690751|Drug|Cenobamate|Cenobamate (YKP3089) is a small molecule approved in the United States (US) for the treatment of partial onset seizures (POS) in adult patients.
15770591|NCT04690738|Diagnostic Test|Fecal Elastase Concentration|Each patient will provide a stool sample for Fecal Elastase Concentration to measure Fecal Elastase-1, a proteolytic enzyme
15770592|NCT04690725|Drug|TQB3525|TQB3525 is an orally bioavailable, potent, class I kinase inhibitors of PI3Ka and PI3Kd.
15770593|NCT04690712|Behavioral|Health Education|"All students who attended the school were provided training by the researchers to improve oral and dental health and general hygiene. These trainings were made using slide shows and various entertaining materials. In addition, education was transformed into a drama with a theater show, and the importance of hand washing, hair and toilet hygiene was explained.
~In addition to hygiene, students were given training on correct eating patterns for a day so that they could develop healthy."
15770594|NCT04690699|Biological|PVSRIPO|PVSRIPO administered via intertumoral injection every 3 weeks
15770595|NCT04690699|Biological|Anti-PD-1 / L1|Anti-PD-1 / L1 Therapy administered per package insert instructions.
15770596|NCT04690686|Device|LW-02 device immunopheresis combined with atezolizumab|The LW-02 device comprises an immunoadsorption affinity column, employing a proprietary human recombinant protein, single chain TNF-α ligand, covalently linked to a bead resin, that both enhances the capture efficiency of sTNF-Rs while avoiding complications from column leaching. Reduced sTNF-R plasma levels may lead to objective tumor responses. In combined treatment arm the immunopheresis procedure is combined with standard dose immunotherapy (atezolizumab) to potentially enhancing its cytotoxic effect.
15770597|NCT04690686|Device|LW-02 device immunopheresis combined with weekly paclitaxel|The LW-02 device comprises an immunoadsorption affinity column, employing a proprietary human recombinant protein, single chain TNF-α ligand, covalently linked to a bead resin, that both enhances the capture efficiency of sTNF-Rs while avoiding complications from column leaching. Reduced sTNF-R plasma levels may lead to objective tumor responses. In combined treatment arm the immunopheresis procedure is combined with low dose chemotherapy to potentially enhancing its cytotoxic effect.
15770598|NCT04690686|Device|LW-02 device immunopheresis|The LW-02 device comprises an immunoadsorption affinity column, employing a proprietary human recombinant protein, single chain TNF-α ligand, covalently linked to a bead resin, that both enhances the capture efficiency of sTNF-Rs while avoiding complications from column leaching. Reduced sTNF-R plasma levels may lead to objective tumor responses.
15770599|NCT04690673|Drug|Paracetamol|1 g oral paractamol
15770600|NCT04690673|Diagnostic Test|Paracetamol concentration measurements and lipidomic assessment|Paracetamol concentration is measured from saline-, urine-, venous blood- and fingerprick- samples at timely intervals. Also serum lipidomic assessment is performed from venous blood samples.
15770601|NCT04690660|Other|Data collection for parameters of organ damage (cardiac and renal blood markers)|Blood results will be taken out of next routine venipuncture. Routinely collected standard parameters are a blood count, chemistry panel including renal parameters and electrolytes, lipid profile and a HbA1c as well as albumin/creatinine and protein/creatinine ratio in urine.
15770602|NCT04690660|Other|Data collection for blood pressure (BP)|Clinic blood pressure and 24hour BP Measurements
15770603|NCT04690660|Other|Home-based blood pressure management (substudy)|Subjects participating in home-based blood pressure management via telemonitoring will receive a free HekaHealth application (App) for the structured assessment of HBPM.
15770604|NCT04690660|Other|Biomarker Profiles (substudy)|Substudy where possible cardiac, renal and pregnancy related biomarkers will be additionally analyzed. The following biomarkers will be analyzed: N terminal (NT)-proBNP, Troponin, elevated mid-regional pro-atrial natriuretic peptide (ANP), elevated mid-regional pro adrenomedullin (ADM), soluble fms-like tyrosine kinase (sFlt-1), and placenta growth factor (PlGF).
15770605|NCT04690660|Other|Data collection on patient reported outcomes|Data collection on patient reported outcomes (Questionnaire EQ-5D, Questionnaire for App based monitoring )
15770606|NCT04690647|Other|Opioid and non opioid postoperative analgesia.|Postoperative analgesia will be based on opioid and non opioid analgesics according to standardised protocol.
15770607|NCT04690647|Other|Fascia iliaca compartment block|Ultrasound guided suprainguinal fascia iliaca compartment block will be performed using 0.375% ropivacaine and 5ug/ml adrenaline according to standardised protocol.
15770608|NCT04690647|Drug|Dexamethasone|Dexamethasone will be administered preoperatively in a dose of 0,1 mg/kg.
15770609|NCT04690634|Procedure|laparoscopic sleeve gastrectomy (LSG)|Multiple studies have indicated that laparoscopic sleeve gastrectomy (LSG) was superior to nonsurgical approaches for the treatment of obese PCOS patients over both the short and long term
15770610|NCT04690608|Drug|Triamcinolone Acetonide 40Mg/Ml Inj,Susp_#1|suprachoroidal injection of the drug in cases of resistant diabetic macular edema and central retinal vein occlusion
15770612|NCT04690582|Behavioral|Cognitive Processing Therapy (CPT)|Cognitive processing therapy (CPT) is a specific type of cognitive behavioral therapy that has been effective in reducing symptoms of PTSD that have developed after experiencing a variety of traumatic events including child abuse, combat, rape and natural disasters. CPT is generally delivered over 12 sessions and helps patients learn how to challenge and modify unhelpful beliefs related to the trauma. In so doing, the patient creates a new understanding and conceptualization of the traumatic event so that it reduces its ongoing negative effects on current life. This treatment is strongly recommended for the treatment of PTSD.
15770613|NCT04690582|Behavioral|Crisis Response Plan (CRP)|The crisis response plan (CRP) is a collaborative, patient-centered intervention that is typically handwritten on an index cards and focuses on several key components: (1) warning signs, (2) self-regulatory strategies, (3) reasons for living, (4) sources of social support, and (5) professional and crisis services.
15770614|NCT04690582|Behavioral|Safety Planning Intervention (SPI)|The safety planning intervention (SPI) is a suicide-focused intervention typically handwritten on a pre-printed form that includes the following sections: (1) warning signs, (2) internal coping strategies, (3) people and social settings that provide distraction, (4) people who can offer help, (5) professionals or agencies they can contact during a crisis, and (6) making the environment safe.
15770615|NCT04690582|Behavioral|Narrative Assessment|"The narrative assessment is a patient-centered assessment approach in which the clinician invites the patient to share the story of a recent crisis or period of intense emotional distress. Patients are asked to identify the thoughts, emotions, and physical sensations experienced in the time leading up to this crisis, as well as the contextual and environmental characteristics surrounding the crisis. Information obtained from the narrative assessment is then used to help formulate a crisis response plan."
15770616|NCT04690569|Diagnostic Test|MeMed BV|The MeMed BV™ Test is an immunoassay that measures three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum samples. The test is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. The test is indicated for use in patients presenting to the ED, urgent care center and inpatients with suspected acute bacterial or viral infection. The MeMed BV™ Test generates a numeric score that falls within discrete interpretation bins based on the increasing likelihood of bacterial infection. The MeMed BV™ test is intended for in vitro diagnostic use only.
15770617|NCT04690556|Drug|Lucentis (ranibizumab)|Lucentis® 0.5 mg via intravitreal injection once monthly
15770618|NCT04690556|Drug|LUBT010 (proposed ranibizumab biosimilar)|LUBT010 (proposed ranibizumab biosimilar) 0.5 mg via intravitreal injection once monthly
15770619|NCT04690543|Procedure|z-plasty|Z-plasty: It will be defined as a local transposition flap that will be used to improve the functional and cosmetic appearance of scars. It will be involved creating two triangular flaps of equal dimensions that will be transposed.
15770620|NCT04690543|Procedure|square flap|Square flap: It will be defined as is another local transposition flap which will be used for release of contractures. Square will be marked on one side of the contracture, and two triangles will be marked on the other side, with the length of all the flaps equal, which will be then transposed.
15770621|NCT04690530|Procedure|mechanical ventilation|mechanical vantilation will be performed
15770622|NCT04690530|Drug|Sedation|sedation wil be performed
15770623|NCT04690517|Procedure|tracheal ultrasound|When checking tracheal ultrasound, several signs are used in judgements. Direct signs include reverberation artifact and double ring sign. Indirect sign means checking the bilateral lung sliding.
15770624|NCT04690504|Other|dim light melatonin onset (DLMO)|A series of saliva samples will be collected and assayed for melatonin so that the timing of melatonin secretion onset can be determined.
15770625|NCT04690491|Other|follicular cyclus|Days of cyclus 6-12
15770626|NCT04690491|Other|luteal cyclus|Days of cyclus 20-24
15770627|NCT04690478|Device|Electronic remote blood pressure monitor|Remote blood pressure management group through remote blood pressure management the platform realizes functions such as automatic upload of patient measurement data, intelligent analysis, and early warning reminders
15770628|NCT04690478|Device|Ordinary household electronic sphygmomanometer|One group is distributed a set of ordinary household electronic sphygmomanometer, and the blood pressure is recorded by themselves at home following routine community office follow-up
15770629|NCT04690478|Device|Office electronic sphygmomanometer|One group follows routine community office follow-up and uses office electronic sphygmomanometer to measure blood pressure
15770630|NCT04690465|Behavioral|Resistance training|"Participants will receive a 16-week resistance training program, with 3 times a week (a total of 48 training sessions) and 60 minutes per session intervention, which is adopted from the 12-week resistance training program introduced in the book Growing Stronger: Strength Training for Older Adults (Seguin et al., 2002), with minor modifications under the advice of Physical Fitness Association of Hong Kong, China (PFA)."
15770631|NCT04690465|Behavioral|Eight-form Yang-style Tai Chi program|The active concurrent control group will receive Eight-form Yang-style Tai Chi program which has been confirmed feasible and will be taught by the qualified coach.
15770632|NCT04690452|Behavioral|Compassion Cultivation Training|The Compassion Cultivation Training (CCT©) is an 8-week standardized meditation program conducted in groups of 15-20 participants and consisting of weekly 2 hour on-line sessions with 20-30 minutes of daily formal meditation practices and informal compassion practices. The CCT© program will be guided by a certified instructor form the Center for Compassion and Altruism Research and Education at Stanford University. The CCT© program comprises six sequential steps: 1) Settling the mind; 2) Loving-kindness and compassion for a loved one; 3) Self-directed loving-kindness and compassion; 4) Common humanity; 5) Cultivating compassion for others; and 6) Active compassion (Tonglen).
15770633|NCT04690439|Device|Photobiomodulation therapy (PBMT)|The MLS M6 laser from ASA will be used to apply the laser therapy.
15770634|NCT04690439|Device|Sham PBMT|The MLS M6 laser from ASA will be used to apply the laser therapy, but the device will not be activated.
15770635|NCT04690426|Biological|PRV-101|Coxsackie Virus B vaccine
15770636|NCT04690426|Other|Placebo|Placebo
15770637|NCT04690413|Device|NOWDx COVID-19 Test|The investigational device is the NOWDx COVID-19 Test.
15770638|NCT04690400|Other|Experimental: Active care group|Stretching exercise program remotely supervised. Total of approximately 40 minutes per session by WhatsApp, individually and supervised by a professional (physiotherapist or physical education teacher). As recommended for flexibility improving, 30 seconds of stretching in each exercise will be perform fractionated (3 series of 10 seconds of static position at the point of moderate discomfort, with 10 seconds interval between series). There will be two stretching protocol models with exercises variations, but for the same muscle groups, intensity, volume, and duration. The position at the point of moderate discomfort will be self-adjusted by subjective perception over 12 weeks of intervention. The protocol model will change after seven weeks. In order to make the interventions more similar, the guide and videos of control group will be also sent to experimental group
15770639|NCT04690400|Other|Active Comparator: Self-care group|The participants will receive counseling to stretching by guide and explanatory video that will be send by WhatsApp. The stretching exercise protocols will be the same performed by the experimental group. In addition, participants will receive recommendation to perform the protocol with the same weekly frequency, intensity, volume, and duration perform by the experimental group After the guide and explanatory video are sent, participants will receive a call for clarification. As well as in the experimental group, the protocol model will change after seven weeks; so, other guide and explanatory video will be sent for participants.
15770640|NCT04690387|Biological|AV-COVID-19|Autologous dendritic cells previously incubated with SARS-CoV-2 spike protein
15770641|NCT04690387|Other|GM-CSF|GM-CSF as an adjuvant
15770642|NCT04690348|Procedure|Craniotomy|Craniotomy
15770643|NCT04690348|Radiation|Cesium-131 brachytherapy|Intracavitary Cesium-131 brachytherapy
15770644|NCT04690335|Biological|MV-012-968|MV-012-968 is a recombinant, live attenuated RSV vaccine.
15770645|NCT04690335|Other|Placebo|Saline solution
15770646|NCT04690322|Drug|Eloctate|Eloctate is FDA-approved to treat patients with Hemophilia A. This drug will be used for extended half-life factor VIII-based replacement therapy.
15770647|NCT04690322|Drug|Adynovate|Adynovate is FDA-approved to treat patients with Hemophilia A. This drug will be used for extended half-life factor VIII-based replacement therapy.
15770648|NCT04690322|Drug|Emicizumab|Emicizumab is FDA-approved to treat patients with Hemophilia A. This drug will be used for non-factor VIII-based replacement therapy.
15770649|NCT04690309|Drug|Treatment with human insulin preparations or treatment with insulin analogues|The doses of human insulin preparations and insulin analogues will be matched individually to achieve target values of blood glucose - fasting < 100 mg/dl (5.5 mmol/L) and postprandial < 140 mg/dl (7.8mmol/L)
15770650|NCT04690296|Device|cathetherization approach|real time ultrasound guidance versus anatomical landmarks subcalvain vein catheterization
15770651|NCT04690283|Drug|Mimetic granules of Yiqi-Wenjing prescriptions|The intervention relates to a multiple granules, which contains 2.5% concentrated Huangqi-Guizhi-Wuwu decoction (a classical traditional Chinese prescription consists of astragalus membranaceus, cassia twig, radix paeoniae alba, ginger and jujube), 2.5% concentrated Danggui-Sini decoction (a classical traditional Chinese prescription consists of angelica sinensis, cassia twig, radix paeoniae alba, asarum, tetrapanax papyriferus, jujube and honey-fried licorice root), bitter principle, food colouring and starch.
15770652|NCT04690283|Drug|Huangqi-Guizhi-Wuwu granules|The intervention relates to a traditional Chinese prescription granules, which contains astragalus membranaceus, cassia twig, radix paeoniae alba, ginger and jujube.
15770653|NCT04690283|Drug|Danggui-Sini granules|The intervention relates to a traditional Chinese prescription granules, which contains angelica sinensis, cassia twig, radix paeoniae alba, asarum, tetrapanax papyriferus, jujube and honey-fried licorice root.
15770654|NCT04690270|Drug|Sumatriptan 100 mg|Single dose Sumatriptan 100 mg
15770655|NCT04690257|Other|Trace Image and Coloring for Kids-Book (TICK-B)|A collection of pictures designed as a book contains and given to children during the procedure and they take a picture as they favored.
15770656|NCT04690244|Other|Tai Chi Chuan trainings|10 weeks of Tai Chi Chuan practice by 6-year experienced training teacher, 2 times per week, 60 min per session.
15770657|NCT04690231|Drug|Apatinib Mesylate|apatinib orally daily and ifosfamide 1.8mg/m2/d d1-3, etoposide 100mg/m2/d d1-3
15770658|NCT04690231|Drug|ifosfamide and etoposide|ifosfamide and etoposide
15770659|NCT04690218|Diagnostic Test|Hospital anxiety and depression scale|Self assessment scale suitable for hospital community as well as public community. Applying the scale does not require any psychopathologic training.
15770660|NCT04690218|Diagnostic Test|Pittsburgh Sleep Quality Index|Self assessment scale for public community. Applying the scale does not require any specially trained personnel.
15770661|NCT04690218|Behavioral|Nutritional Status Questionnaire|It consists of 26 items, questioning the frequency and amount of certain nutritional elements (ones known to worsen and benefit mastalgia) consumed by the individual.
15770662|NCT04690205|Other|End of Life (EOL) Care at at Home|Remote monitoring and home-based care designed for patients with advanced hematologic malignancies
15770663|NCT04690192|Biological|CNCT19|2×10^6/kg, infused in a single-dose on day +2, +3 or +4 following stem-cell infusion
15770664|NCT04690192|Drug|Gemcitabine Injection|600mg/m2/h, infused for 3 hours with loading bolus of 75mg/m2, day -7, -3,
15770665|NCT04690192|Drug|busulfan|105mg/m2, day -7 until -5,
15770666|NCT04690192|Drug|Melphalan Injection|60mg/m2, day -3, -2
15770667|NCT04690166|Other|The speech records related to the reading document|"The document consists bit, bet, but words and Diyet passage. Volunteers will read the document in front of the microphone and also the speech will recorded by a computer."
15770668|NCT04690153|Other|Patients with three vertical Hayman Sutures|Patients who are referred to our clinic due to postpartum hemorrhage between the ages of 18-45 and who need to undergo a surgical procedure (not responding to medical treatment) due to abnormal uterine bleeding in our clinic will be included. Patients with a previously known diagnosis of bleeding and coagulation disorders will not be included in the study. Considering that we are one of the primary referral centers in Istanbul in terms of deliveries and post-partum bleeding in our hospital, it is aimed to terminate the study with approximately 50 participants.
15770669|NCT04690140|Procedure|Epithelialized free gingival graft|The Epithelialized free gingival graft placed on the prepared bed.
15770670|NCT04690140|Procedure|Modified coronally advanced tunnel technique|Connective tissue graft placed under the prepared tunnel
15770671|NCT04690127|Other|Plyometric Exercise|Plyometric training consisting of ten different exercises [vertical unilateral and bilateral counter movement jump, horizontal unilateral and bilateral counter movement jump, drop jump (30 cm), squat jump, step-hop (20 cm), 180 degree rotation in transverse plane, frontal plane hurdle jump (20 cm) and sagittal plane hurdle jump (20 cm)] for 8 weeks, 3 sessions per week. Individuals will not participate in a real plyometric training. Volunteers will watch videos to be prepared (action observation) and imagine them performing those exercises (motor imagery)
15770672|NCT04690101|Other|none, this is an observational study|none, this is an observational study
15770673|NCT04690075|Dietary Supplement|Nutrition Management and Dietary Fiber|Routine nutrition management and dietary fiber supplements based on recommendation for 12 weeks.
15770676|NCT04690049|Other|Neuromuscular resistance exercise program|This neuromuscular resistance exercise program will be organized in 5 stages, distributing the different phases in 2, 4, 4, 2 and 2 weeks respectively, with a frequency of 3 sessions/week. In addition, 2 weekly sessions of aerobic work with cycloergometer will be developed. The duration of each session will last 30 minutes. The parameters of load and execution speed will be modified as the exercise program progresses along the phases, with the goal of have an impact on the different aspects of the neuromuscular system.
15770677|NCT04690049|Other|Control exercise program with elastic band|"This program is based on previous literature so that it remains comparable to the experimental program.
~The parameters will consist in 3 sets of 10 repetitions, 2 times/day, 3 times/week, for a total of 6 weeks."
15770678|NCT04690036|Drug|toripalimab injection|when EBV-DNA is positive after allo-HCT, and EBV infected T/NK cell, one dose of toripalimab 3mg/kg would be used, the same dose would be repeated 4 weeks later.
15770679|NCT04690023|Procedure|Pericapsular nerves group (PENG) block|Patients scheduled for total hip arthroplasty with spinal anesthesia receive before intra-thecal injection, ultrasound-guided PENG block with injection 20 ml of ropivacaine 0,75%, between the anterior hip articular capsule, the ilii-psoas muscle, the ileo-pubic eminence and the antero-inferior iliac spine.
15770680|NCT04690023|Procedure|Supra-inguinal fascia-iliaca compartment block|Patients scheduled for total hip arthroplasty with spinal anesthesia receive before intra-thecal injection, ultrasound-guided supra-inguinal fascia iliaca compartment block with injection over de inguinal ligament of 40 ml of ropivacaine 0,375%, between de ilio-psoas muscle and internal oblique muscle.
15770681|NCT04690023|Drug|Ropivacaine 0,75% in PENG block|20 ml injection of ropivacaine 0,75%
15770682|NCT04690023|Drug|Ropivacaine 0,375% in SFICB block|40 ml injection of ropivacaine 0,375%
15770683|NCT04690010|Procedure|Ambulatory tubeless PCNL|Patients will be discharged the same day of surgery. No nephrostomy tube will be left in place. A ureteral stent on a string may be left for up to 5 days.
15770684|NCT04690010|Procedure|Inpatient PCNL with nephrostomy tube|Patients will be admitted to hospital for 1-3 days. A nephrostomy tube will be placed at the time of surgery that will be removed prior to discharge.
15770685|NCT04689997|Behavioral|cSBI|The standard CRAFFT SU screen has additional questions about reasons to use or not use, SU expectancies of effect and embedded education. The teens of enhanced care PCPs will also complete a Strengths and Goals tool. Data from both will be used by the PCP in counseling regarding continued abstention, reduction or cessation of SU or referral. Teens will also get monthly text messages about goals.
15770686|NCT04689984|Drug|Standard therapy|Gabapentin, pregabalin, or amitriptyline
15770687|NCT04689984|Drug|Astaxanthin|Astaxanthin 6 mg tablet once daily
15770688|NCT04689971|Drug|Standard therapy|Gabapentin, pregabalin, or amitriptyline
15770689|NCT04689971|Drug|Vitamin B combination|Vitamin B combination (B1 100 mg, B2 200 mg and B12 200 mcg) tablet once daily
15770690|NCT04689958|Drug|Standard therapy|Gabapentin, pregabalin, or amitriptyline
15770691|NCT04689958|Drug|Vitamin D 5,000IU Oral Tablet|Vitamin D 5000 IU oral tablet once daily
15770695|NCT04689932|Drug|Triferic AVNU|Ferric Pyrophosphate Citrate
15770696|NCT04689919|Drug|Rivaroxaban 20 MG Oral Tablet|The subjects randomly received single oral dose of Rivaroxaban 20 MG Tablet.
15770697|NCT04689906|Other|surgery|This is a retrospective study that includes patients operated for suspicion of acute appendicitis
15770698|NCT04689893|Drug|68Ga-Dotatate|68Ga-Dotatate was injected into the patients before the PET/CT scans
15770699|NCT04689893|Drug|68Ga-DOTA-JR11|68Ga-DOTA-JR11 was injected into the patients before the PET/CT scans
15770700|NCT04689867|Behavioral|Cognitive Behavioral Suicide Prevention for psychosis CBSPp)|Cognitive and behavioral approach to suicide prevention among individuals with psychosis
15770701|NCT04689841|Other|Vojta Therapy|"Reflex locomotion is activated by the reflexogenic pathway. In context with reflex locomotion, the term reflex does not represent the mode of neuronal control, but rather refers to defined, automatic and always equal motor responses produced by external stimuli, applied therapeutically."
15770702|NCT04689841|Other|placebo|In the control group, a placebo intervention is administered, similar to an experimental intervention
15770707|NCT04689815|Drug|Oral Arsenic Trioxide Formulation|Eligible subjects with NPM1 MRD positivity will receive oral arsenic trioxide (oral-As2O3) (Arsenol ®) (5-10mg per day, from days 1-7 per cycle), ascorbic acid (1g per day, from days 1 - 7 per cycle) plus azacitidine (75mg/m2 per day subcutaneously, from days 1 to 3 per cycle). Each cycle of oral-As2O3 plus azacitidine will be given once every 28 days. The total duration of treatment is 12 months (12 cycles). Treatment will be day-care and outpatient based. Reduction in the dosage and duration of oral-As2O3 is required if the subject is experiencing adverse events (AEs). In case of grade 3 or above toxicity, the dosage of oral-As2O3 will be reduced to 5mg per day.
15770708|NCT04689789|Diagnostic Test|optical coherence tomography angiography|optical coherence tomography aniography is a non-invasive, fast, diagnostic imaging technique that evaluates the retinal vascular network
15770815|NCT04688788|Drug|Ocrelizumab|Ocrelizumab is a recombinant humanised monoclonal IgG1 antibody which depletes CD20-positive cells. Ocrelizumab is approved for multiple sclerosis.
15770709|NCT04689776|Behavioral|Dual-Task Training|The programs are based on dual-task trainings which contain cognitive training and exercise simultaneously. For physical exercise, we will design the programs that involve balance or strength training components in the aerobic exercises. In terms of cognitive training, we will design self-made teaching aids and board games to train different domains of cognitive functions. We plan to assess the participants before and after the intervention programs. We expect that elders receiving dual-task training will improve on outcome measures, and the group with more frequency will have better performance. The results of the study will provide evidence of interventions for elderly with cognitive decline, thereby reducing the burden on their caregivers and the cost of medical resource.
15770710|NCT04689763|Behavioral|Training|The programs contain sequential cognitive and exercise training, health lectures, and groups of daily living participation. We plan to assess the participants before and after the intervention programs. We expect that elders receiving training will improve on outcome measures. The results of the study will provide evidence of interventions for elderly with cognitive decline.
15770711|NCT04689750|Diagnostic Test|Next generation sequencing|"Genetic profile of donors will be collected at the time of PBSC or BM stem cell donation. Genetic profile of recipients will be collected at 1-month, 6-month, 12-month post-HSCT and at time of relapse or occurrence of leukaemia.
~Gene mutations and pathogenic gene fusion will be determined in the peripheral blood and/or marrow samples by next-generation sequencing (NGS) using a myeloid-gene panel and nanopore long-read sequencing."
15770712|NCT04689737|Drug|Doravirine|Participants will be told to take one tablet of doravirine (Pifeltro, MDS) once daily, with or without food, approximately at the day time that they usually finish the hemodialysis sessions. The rest of their antiretroviral regimen and concomitant medications will remain unchanged
15770713|NCT04689698|Diagnostic Test|Thomayer test|Testing of the ankle in sagittal line and Thomayer test before and after flossing of sole.
15770714|NCT04689685|Other|Wearing smartwatch and continous glucose sensor|Patients will be wearing a smartwatch and a continuous glucose meter (CGM) over a maximum duration of 3 months in an outpatient setting.
15770715|NCT04689672|Diagnostic Test|Lung ultrasound|Bedside lung ultrasound
15770716|NCT04689659|Biological|chimeric antigen receptor T cell treatment|CD7 CAR T cells will be given once intravenously at one dose (1×106, with an allowance of ± 20%) in patients received previous HSCT donor-derived CAR T cells. Patients who received fresh donor derived CD7 CAR T cells were given initial dose of 1×106, with an allowance of ± 20%. The dose levels may be adjusted during the study based on the specific number of cells on the day of fresh CAR T cells infusion, due to at this time all the patients have completed lymphodepleting, so we adopt the allowance of ±20% for each group of absolute infusion cells. And patients who were lower than the designed dose group were also given infusion, but they will be either assigned to the lower dose group or exclude from safety analysis.
15770717|NCT04689646|Behavioral|Mind Body Intervention 1|Mind body techniques for Intervention 1 will be taught in lectures and group discussion sessions.
15770718|NCT04689646|Behavioral|Mind body intervention 2|Mind body techniques for Intervention 2 will be taught in lectures and group and/or individual sessions.
15770719|NCT04689633|Procedure|nerve block|bilateral ultrasound-guided posterior quadratus lumborum block was done in the lateral decubitus and linear or curvilinear probe was used according to the depth and placed in the midaxillary line in the transverse plane above the iliac crest
15770720|NCT04689620|Device|laser|treating the venous ulcer with laser
15770721|NCT04689607|Other|Mulligan Traction Straight Leg Raise (TSLR)|The patient was in a supine position on a low bed and the therapist faced the limb of the patient that was to be treated. The therapist grasped the lower leg of the patient just near the ankle and raises the leg off the bed to a position just above the painful range. The therapist flexes the knees. Traction was retained as far as possible with a straight leg lift if there was no pain. The pain-free traction straight leg raise range was administered for 10 second and the procedure was repeated three times.
15770722|NCT04689607|Other|Post Isometric Relaxation technique (PIR):|The knee of the affected leg was extended, and the affected hip was flexed. Then the calf of the patient was placed on the shoulder of therapist. The therapist was standing on the side of the affected leg. The flexion of the hip was performed on the affected leg until resistance was felt. The patient was asked to gently push down on the therapist's shoulder with the leg. The therapist resisted hip extension to create an isometric contraction. The duration of the contraction was 10 seconds. Then the patient was instructed to relax and the therapist gently flexed the hip until the next barrier was felt. The technique was repeated three times.
15770723|NCT04689594|Combination Product|CLS2702C/CLS2702D|"CLS2702C (cell sheet) will be transplanted to the wound site using CLS2702D (transplantation device) (screening period, 1 month [4 weeks]; cell sheet culture period, 0.5 month; transplantation and assessment period, 6 months [24 weeks]); follow-up period, 6 months [24 weeks]) Other Names: •Human (autologous) oral mucosal cell sheet
~•Transplantation device"
15770724|NCT04689581|Other|Ultrasound guided bi-level erector spinae plane block|Bi-level ultrasound (US)-guided Erector spinae plane block (ESP) with 30 ml 0.25% bupivacaine at the T2 andT4 vertebral level will performe preoperatively to all patients in the ESP group.
15770725|NCT04689581|Other|Ultrasound guided modified pectoral nerve block|Ultrasound (US)-guided modified pectoral nerve block (PECs) with 30 ml 0.25% bupivacaine will performe preoperatively to all patients in the PECs group.
15770726|NCT04689568|Behavioral|Moodkit|"MoodKit is divided into four main sections: Activities, Thoughts, Mood and Journal. In the Thoughts section, the user is asked to briefly describe stressful situations and their reactions to the event and is later educated on a number of thought distortions. In the Mood section, the user is asked to give an overall rating of mood, which can be done several times per day. In the Journal section, the user can write freestanding journal entries. Additional areas of advice and goal setting are contained in a section called Thrive Tips."
15770727|NCT04689568|Behavioral|Moodgym|The program consists of five modules each taking 20- to 40-minutes to complete, which are completed in a prescribed order.
15770728|NCT04689568|Behavioral|University of Michigan Depression Center Toolkit|The Toolkit provides information, tools, support, and resources to guide individuals through their mental health journey.
15770729|NCT04689555|Procedure|Novel method without manual compression|Novel method for femoral artery hemostasis without manual compression. After sheath removal, four or five sterile gauzes were overlaid layer by layer and then bandaged without the procedure of manual compression.
15770848|NCT04688580|Drug|XW10172|Various formulations
15770730|NCT04689555|Procedure|Standard method with manual compression.|Standard method for femoral artery hemostasis with manual compression.After sheath removal, manual compression was continued for at least 10 minutes or until hemostasis. After that four or five sterile gauzes were overlaid layer by layer and then bandaged without the procedure of manual compression.
15770731|NCT04689542|Other|Sit-To-Stand test|The 1-minute sit-to-stand test will be realized with or without a surgical facemask covering the face of the patient with COVID-19
15770733|NCT04689516|Device|Thoracic fluid content estimation|The patient will be monitored for thoracic fluid content and LUS score. The infusion will stop if TFC reaches 40 k ohm-1 or after completion of the infused volume. LUS evaluation will be done before the start and after the end of the infusion.
15770735|NCT04689477|Device|Vascular occlusion test|The ischemic challenge will consist in a standardized Vascular Occlusion Test (VOT), as previously described in the literature. Briefly, a blood pressure cuff will be placed proximal to the forearm, and rapidly inflated at 40 mmHg above systolic pressure, and kept inflated during three minutes. Then the cuff will be rapidly deflated. The resulting deoxygenation (DeO2) and reoxygenation (ReO2) slopes will be reported as change in O2 saturation over time.
15770736|NCT04689438|Diagnostic Test|gingival crevicular fluid|GCF samples were collected in the morning hours 24-48 hours after clinical periodontal measurement.
15770737|NCT04689425|Drug|Umbilical cord blood mononuclear cell gel（MNC）|Local wound treatment by combination of PRP and MNC, once;
15770738|NCT04689425|Drug|The platelet rich plasma（PRP）|Local wound treatment by PRP alone, once.
15770739|NCT04689412|Drug|Resveratrol|Nasal administration of resveratrol
15770740|NCT04689399|Diagnostic Test|Standard Q COVID-19 Ag - test, produced by SD Biosensor INC.|Alle Danish citizens tested for infection with SARS-CoV-2 by swabs in the oropharynx, and subsequently analysis of the specimens by RT-PCR test at Testcenter Danmark's test centers will be included in the study. Participants will, in addition to the oropharyngeal swab they are already schedule for, be examined by a rapid antigen test.
15770741|NCT04689386|Other|"Group I (GE-I) - Stimulation of reflex rolling from the Vojta method"|"This manoeuvre does not require the newborn to be moved, but only a slight rotation of the head towards the side from which the stimulus is delivered. The starting position for performing the first phase of reflex rolling is the asymmetric supine position, with the limbs freely lying on the resting surface.
~A digital pressure will exert on the chest area, where the mammillary line crosses the insertion of the diaphragm, either at the level of the 6th rib, or between the 5th and the 6th, or between the 6th and the 7th. A one minute stimulus will be performed on each side. The intervention will be repeated twice a day, ensuring that the period between one intervention and another is at least two hours."
15770742|NCT04689386|Other|Group II (GE-II) - expiratory flow increase technique|The technique adapted to the premature infant will be performed. This maneuver consists of slowly applying light pressure to the infant's chest with one hand, obliquely, starting from the end of the inspiratory plateau until the end of expiration, which is prolonged. The hand should be placed between the sternal notch and the xiphoid process of the newborn's sternum. The therapist's other hand is placed on the last ribs (without applying pressure) as a bridge, of which the columns are the thumb and forefinger (or middle finger). Therefore, contact with the infant's abdomen is avoided and the expansion of the lower rib is limited, allowing a better displacement of the diaphragm and avoiding an increase in intra-abdominal pressure. The maneuver will be repeated three times, respecting the infant's responses and their physiological constants. The intervention will be repeated twice a day, trying to ensure that the period between one intervention and another is at least 2 hours.
15770745|NCT04689347|Drug|Bevacizumab|Bevacizumab 5 mg/kg intravenous infusion every 2 weeks
15770746|NCT04689347|Drug|Irinotecan|irinotecan 165 mg/sqm intravenous infusion every 2 weeks
15770747|NCT04689347|Drug|Leucovorin|leucovorin 200 mg/sqm intravenous infusion every 2 weeks
15770748|NCT04689347|Drug|5Fluorouracil|48-hours continuous intravenous infusion of 5-fluorouracil (5-FU) 3200 mg/sqm every 2 weeks
15770749|NCT04689347|Drug|Temozolomide|Oral temozolomide with progressive dose escalation at inter-patient level over days 1-5 every 28 days. (75 mg/sqm; 100 mg/sqm; 125 mg/sqm or 150 mg/sqm)
15770750|NCT04689334|Other|Outcome|The number of surgeries
15770751|NCT04689321|Other|No intervention|This is not an interventional study.
15770752|NCT04689308|Drug|MH048|Soft gel capsules 5 mg and 25 mg，oral MH048 should be administered after an overnight fast.
15770753|NCT04689295|Other|exercise programme 1|Schroth three dimensional scoliosis therapy method
15770754|NCT04689295|Other|exercise programme 2|Traditional scoliosis exercises
15770755|NCT04689282|Biological|Bioactive Factors, Produced by M2 Type Macrophages (M2-BFs).|Intranasal delivery of M2-BFs is performed with the aerosol inhaler device (nebulizer), 2.0 mL once a day up to 30 days.
15770756|NCT04689269|Other|"The simulated easy airway"|A high-fidelity simulator (Airway Management Trainer, model AA-3100, Laerdal Medical Ltd., Orpington, England, UK) will be equipped to create an easy airway situation by adjusting the manikin until it becomes in a neutral position
15770757|NCT04689269|Other|"The simulated difficult airway"|"A high-fidelity simulator (Airway Management Trainer, model AA-3100, Laerdal Medical Ltd., Orpington, England, UK) will be equipped to create a difficult airway scenario will be established by placing the occiput on an Oasis Elite™ Prone Head Rest, Adult (140 mm in height) (Covidien, Mansfield, MA, USA), and inhibiting head and neck movement by securing the head with an adhesive tape, simulating the effect produced by a cervical-collar."
15770758|NCT04689269|Device|King Vision Laryngoscope|Using a King Vision Laryngoscope for placement of the DLT
15770759|NCT04689269|Device|MacGrath Laryngoscope|Using a MacGrath Laryngoscope for placement of the DLT
15770760|NCT04689256|Device|MR-010|MR-010 includes a patient application and sensors with commercially available headphones and smartphones. Sensors are placed on the subject's shoes and measure gait metrics. The algorithm uses data from the sensors to inform changes made to the audio cues. These cues, which are embedded in time-shifted music, are delivered back to the users who aim to walk to the beat.
15770761|NCT04689243|Procedure|ALA-PDT|Low concentration ALA-PDT, 3 times a week.
15770762|NCT04689243|Procedure|red light|red light, 3 times a week.
15770763|NCT04689230|Procedure|upper eyelid blepharoplasty|upper eyelid blepharoplasty
15770764|NCT04689217|Drug|intrathecal drug injection|"All patients will be put in the sitting position and lean forward. After sterilization, Dural puncture will be performed at L4-L5 interspace or L3-L4 with a 25 gauge Quincke spinal needle.
~The patients will be divided equally into 3 groups according to the additive (fentanyl, nalbuphine or placebo), and all patients will receive the local anesthetic dose of 0.5% heavy bupivacaine according to weight and height"
15770765|NCT04689204|Drug|CTA30X|CTA30X cell injection by intravenous infusion
15770766|NCT04689191|Biological|Experimental Group A and C meningococcal polysaccharide vaccine|One dose of Experimental Group A and C meningococcal polysaccharide vaccine
15770767|NCT04689191|Biological|Control Group A and C meningococcal polysaccharide vaccine|One dose of Control Group A and C meningococcal polysaccharide vaccine
15770768|NCT04689178|Other|Invitation letter + GP reminder|40-65 year-old women who did not perform a PAP test over the last 3 years will receive an invitation to consult a health professional to perform a screening test, AND GPs will receive the list of their 40-65 year-old patients who did not perform a PAP test over the last 3 years
15770769|NCT04689178|Other|Invitation letter|40-65 year-old women who did not perform a PAP test over the last 3 years will receive an invitation to consult a health professional to perform a screening test. GPs will NOT receive any list of their non-adherent patients.
15770770|NCT04689165|Biological|Experimental Group A meningococcal polysaccharide vaccine|Two doses of Experimental Group A meningococcal polysaccharide vaccine at the vaccination schedule of week 0, 12
15770771|NCT04689165|Biological|Control Group A meningococcal polysaccharide vaccine|Two doses of Control Group A meningococcal polysaccharide vaccine at the vaccination schedule of week 0, 12
15770772|NCT04689152|Biological|Cellgram-LC|Patients will receive single injection of Cellgram-LC(mesenchymal stem cell) hepatic artery.
15770773|NCT04689139|Diagnostic Test|blood sample tests for determination of biomarkers levels|Using of proadrenomedullin, presepsin, NT-proBNP, Troponin I to determine the correlation of perioperative complications.
15770774|NCT04689126|Procedure|surgical or nonsurgical endodontic treatment|Change in diagnosis and treatment plans between the two imaging - periapical radiography and cone beam computed tomography
15770775|NCT04689113|Behavioral|Incontinence Health Belief Development Program|After the applied interventions, it is desired to develop kegel exercise behavior in women.
15770776|NCT04689100|Drug|JMT101|Monotherapy: Accelerated titration method, IV infusion QW; Conventional 3 + 3 study design, IV infusion Q2W. (28-day cycles) Combined with chemotherapy: Conventional 3 + 3 study design, IV infusion Q2W. (28-day cycles)
15770777|NCT04689100|Drug|JMT101|IV infusion Q2W (28-day cycles)
15770778|NCT04689087|Combination Product|TTFields|For patients with relapsed GBM, before receiving electric field treatment, the patient can be re-operated, and TTFields+BPC chemotherapy is used after surgery
15770779|NCT04689074|Other|Biological sample collection|Collection of faeces, urine, saliva, PBMC and blood for biobanking, to evaluate the proteomic, metascriptomic, metabolomic, metagenomic, and metagenetic profile, and to perform routine screening
15770780|NCT04689074|Other|Questionnaire|Anamnestic questionnaire, 3-day food questionnaire, Food Frequency Questionnaire
15770781|NCT04689074|Other|Medical examination|Blood pressure measurement, abdominal and thoracic physical examination
15770782|NCT04689061|Device|Arthrex FastThread Interference Screw|The Arthrex PEEK and Biocomposite FastThread Interference Screws have a tapered hexalobe design along the entire length of the screw to maximize transfer of torque and reduce screw stripping. The Arthrex PEEK and Biocomposite FastThread Interference Screws have a tapered hexalobe design along the entire length of the screw to maximize transfer of torque and reduce screw stripping
15770783|NCT04689048|Drug|18F fluciclovine|Patients will receive a standard 5 millicuries dose of 18F-fluciclovine intravenously as a bolus injection. They will be required to fast for at least four hours prior to 18F-fluciclovine injection. Patients will be positioned for PET/CT brain imaging and will be injected with 18F-fluciclovine immediately prior to PET data acquisition. PET data will be collected in list mode up to 25 minutes post-injection. PET images will be reconstructed in two ways: as a standard static image of data acquired between 10 to 20 minutes post-injection, and as a dynamic series of four 5-minute frames between 5 to 25 minutes post-injection to allow for motion assessment and correction and time-dependent observations.
15770784|NCT04689035|Drug|AVLX-144|Test drug
15770785|NCT04689035|Drug|Placebo|Placebo
15770786|NCT04689022|Behavioral|Mississippi Scale for Combat-Related PTSD (M-PTSD)|The treatment outcome rate was assessed by the Mississippi Scale for Combat-Related PTSD (M-PTSD). A positive outcome rate is represented with the patient post-discharge positive coping, which corresponds to 94-58 points, observed in 39 patients (17.9%). A treatment failure is regarded as the absent PTSD treatment effect after discharge, which corresponds to 148-113 points, observed in 5 patients (2.3%) and psychic disorders, which correspond to 112-95 points, observed in 174 patients (79,8%).
15770787|NCT04689022|Diagnostic Test|visual analogue scale (VAS)|pain intensity
15770788|NCT04689022|Diagnostic Test|Douleur Neuropathique 4 questions (DN4)|neuropathic pain component
15770789|NCT04689009|Device|EmoLED|The treatment with EmoLED, in addition to the SOC, will be performed during each visit for 60 seconds on each 5 cm diameter sub-area of the selected lesion.
15770790|NCT04689009|Procedure|current Standards Of Care|"The lesions will be cleansed with saline solution and, if necessary, surgical debridement will be performed with the most suitable method. At this point, if patient is included in EmoLED Group, the EmoLED treatment starts. After EmoLED application (EmoLED Group) or after cleansing (SOC Group), a polyurethane foam dressing will be applied on the lesion. In case of clinical signs of infection, a silver dressing will be applied.
~Then an elasto-compressive double layer dressing of the limb with cohesive fixation bielastic latex-free bandage will be carried out."
15771734|NCT04681430|Drug|Placebo for Camostat Mesilate|Placebo Tablets over 7 days, split into 3 doses
15770791|NCT04688996|Diagnostic Test|Lateral Flow Assay for Pathogens of the Plague|A dipstick type of rapid test for antigens of the plague bacterium Yersinia pestis in samples from enrolled participants from both a known geography of plague activity (Madagascar) as well as samples from a geographically separated population of likely plague free status (US Naval Health Research Center, San Diego, CA).
15770792|NCT04688983|Drug|Ponatinib|30 mg QD starting day 1, given continuously unless interruption required for toxicity
15770793|NCT04688983|Drug|Blinatumomab|A single cycle of blinatumomab treatment is 6 weeks in duration, which includes 4 weeks of blinatumomab CIVI followed by a 2-week treatment-free interval.
15770794|NCT04688983|Drug|Imatinib|starting day 1, given orally at 400mg BID continuously for 8 weeks
15770795|NCT04688970|Other|no intervention|no intervention
15770796|NCT04688957|Procedure|oseodensification sinus lifting|application of first densah bur with densifying mood (reverse) counterclockwise, 1200 revolution per minute until the sinus is reached then use a wider densah bur with the same mode and bouncing motion to elevate the sinus floor up to 3 mm in 1mm increments.
15770797|NCT04688957|Procedure|osteotome sinus lifting|drilling implant site with consecutive drills short of the sinus floor by 1-2mm , using osteotome in appropriate size and application of one tap until sinus floor is elevated, using the final drill for the desired implant diameter
15770798|NCT04688944|Other|observation|observation the difference between two groups
15770799|NCT04688931|Drug|UGN-102|UGN-102 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation. The reverse thermal properties of UGN-102 allow for local administration of mitomycin as a liquid, with subsequent conversion to a semi-solid gel depot following instillation into the bladder.
15770800|NCT04688931|Procedure|TURBT|The current standard of care for treatment of LG IR NMIBC is TURBT under general anesthesia.
15770801|NCT04688918|Procedure|Retrolaminar block|A high-resolution 5-12 MHz linear probe with a sterile cover will be used to perform the block. The patient will be placed in a prone position with a pillow under the chest. The spinous process of the fourth thoracic vertebrae will be identified and marked. Under complete sterilization, the ultrasound high frequency linear probe will be placed in a para-sagittal position, just lateral to the spinous processes of thoracic vertebra, to identify the vertebral lamina. A 50 mm 22-gauge needle will be inserted in an in-plane technique from cranial to caudal direction and will be advanced till hitting the laminae of fourth thoracic vertebrae and then we will try to inject the local anesthetic, if the resistance to injection is very high, hence we will withdraw the needle slowly and its tip will be kept in its position immediately after disappearance this high resistance. Bupivacaine 0.25%, 0.4mL/kg will be injected.
15770802|NCT04688918|Procedure|paravertebral group|A high-resolution 5-12 MHz linear probe with a sterile cover will be used to perform the block. The patient will be placed in a prone position with a pillow under the chest. The transverse process of the fourth thoracic vertebrae will be identified and marked. Under complete sterilization, the ultrasound high frequency linear probe will be placed in a para-sagittal position, just lateral to the spinous processes of thoracic vertebra, to identify the vcostotransverse ligament, 0.4mL/kg will be injected
15770803|NCT04688905|Diagnostic Test|Invasive hemodynamics of left ventricle via conductance catheter at rest, with exercise and with temporary vena cava occlusion|Invasive hemodynamics of left ventricle will be done by the conductance method. Left ventricular stiffness constant will be obtained by temporary vena cava occlusion. Right heart catherization will be done by pulmonary artery catherization and cardiac output will be estimated by thermodilution and Fick´s method.
15770804|NCT04688892|Device|Cupping|dynamic cupping
15770805|NCT04688879|Procedure|intra-arterial urokinase thrombolysis|Under local anaesthesia, the right femoral artery was punctured in accordance with the Seldinger technique, and a 6-Fr sheath, 10 cm in length, was implanted. Selective catheterization of the SMA was performed with 4-Fr catheter. The SMA angiography was performed to identify the filling defect. Thrombolysis was performed using a 5-Fr multiple-sideport infusion catheter (100cm with sideport of 7cm, 14 ports or 100cm with sideport of 15cm, 30 ports, Cook, Bloomington, IN, U.S.A). The tip of the microcatheter was embedded in the thromboembolism, which was fragmented at the time of thrombolysis. Thrombolysis was performed locally in the SMA with a bolus of urokinase
15770806|NCT04688866|Other|Sequencing|This is an observational study, since the assignment of the medical intervention (e.g. cerclage or pessary) is not at the discretion of the investigator. However, cervical samples collected from both groups are subjected to amplicon sequencing for taxonomic classification of microorganisms.
15770807|NCT04688853|Biological|TEG002|TEG002 cells are autologous T cells transduced with a specific γδTCR
15770808|NCT04688840|Procedure|hip arthropalsty|follow up of patients with primary hip arthroplasty with at least one year follow up electronically and by routine method
15770809|NCT04688827|Other|Exercise therapy|15 weeks of resistance training (additional to endurance training)
15770810|NCT04688814|Procedure|Single puncture combined lumbar erector spinae plane block and quadrates lumborum block|"Patients will lay laterally with the fracture side independent, a curvilinear transducer will be placed in a parasagittal plane 3-4 cm lateral to the lumbar spinous process of L4.The probe is shifted slowly to the lateral side till the transverse processes disappear. After subcutaneous local infiltration with lidocaine 1% at the cephalic end of the probe, the block needle is advanced through the erector spinae and QL muscles, until it pierces the epimysium of the QL muscle. LA is injected anterior to the QL, between the QL and psoas muscles.
~Then the caudal end of the probe is rotated slowly medially towards lumbar spine till the transverse process of L4 appears in the ultrasound image. The needle is withdrawn to subcutaneous tissue, then advanced in plane towards transverse process of L4. After contacting it, LA is deposited between transverse process and overlying ESM."
15770811|NCT04688814|Drug|Morphine Sulfate|Patients will receive GA and analgesia will be based on opioids mainly intravenous morphine
15770812|NCT04688801|Drug|Chemotherapy Drugs, Cancer|Chemotherapy± Radiotherapy after surgery
15770813|NCT04688801|Drug|Immunotherapy|Chemotherapy + Immuonotherapy ± Radiotherapy after surgery
15770814|NCT04688788|Drug|Rituximab|Rituximab is a chimeric mouse/human monoclonal immunoglobulin gamma-1 (IgG1) antibody which depletes cluster of differentiation antigen 20 (CD20)-positive cells. Rituximab is approved for non-hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangitis and microscopic polyangitis, and pemphigus vulgaris.
15771735|NCT04681430|Other|Standard of Care (SoC)|Control Arm for convalescent plasma (CP)
15770816|NCT04688788|Drug|Fexofenadine|Premedication with oral fexofenadine 360 mg is given before every infusion to reduce frequency and intensity of infusion related reactions.
15770817|NCT04688788|Drug|Paracetamol|Premedication with oral. paracetamol 1000 mg is given before every infusion to reduce frequency and intensity of infusion related reactions.
15770818|NCT04688788|Drug|Methylprednisolone|Premedication with oral methylprednisolone 100 mg is given before every infusion to reduce frequency and intensity of infusion related reactions.
15770821|NCT04688762|Other|e-consult application (tool)|A numeric application used as a support in consultation to explain the surgical management of the patient.
15770822|NCT04688749|Diagnostic Test|Electrical Impedence Spectroscopy DermaSense|Two sets of measurements will be performed to each subject, either at a nevus in contrast with a nearby clear patch of skin. The duration of each measurement will last for approximately 1.5 minutes and the excel file will be directly available to researcher, allowing him/her for data storage and data visualization.
15770823|NCT04688736|Drug|Placebo|The tablet resembles chlorpheniramine but has no therapeutic value.
15770824|NCT04688736|Drug|Chlorpheniramine|An antihistamine that reduces the natural chemical histamine in the body.
15770825|NCT04688723|Drug|Dabigatran + Ticagrelor|Patiënt interventional treatment, with dabigatran + ticagrelor (Brilique) 90mg twice daily up to 12 months.
15770826|NCT04688723|Drug|Dabigatran + clopidogrel|Patiënt interventional treatment, with dabigatran + clopidogrel (plavix) 75mg once daily up to 12 months.
15770827|NCT04688710|Behavioral|Self-Hypnosis (HYP)|"Self-Hypnosis (HYP) teaches skills people with MS can use to effectively self-manage symptoms related to fatigue. Recordings are designed to help participants learn new strategies for influencing fatigue and its effects on their lives. The Self-Hypnosis recordings will start with a relaxation hypnotic induction (e.g., Notice how with each breath, you are feeling more and more relaxed …) followed by hypnotic suggestions (e.g., for experiencing more energy, improved sleep, more comfort or less pain, etc.). The goal of Self-Hypnosis is to change participant's experiences. To the extent that participants respond to the suggestions, participants would then get more control over their feelings of energy, sleep quality, and comfort levels."
15770828|NCT04688710|Behavioral|Mindfulness Meditation (MM)|"Mindfulness Meditation (MM) teaches skills people with MS can use to effectively self-manage symptoms related to fatigue. Recordings are designed to help participants learn about a new way to live with chronic fatigue and new ways to relate to how fatigue may influence their thoughts, feelings, and behavior. The mindfulness techniques train the mind to non-judgmentally observe experience (e.g., symptoms of fatigue or pain, etc.) on a moment-to-moment basis, with an attitude of acceptance. The goal of Mindfulness Meditation is not to alter experiences, but rather to change how someone responds to their experiences. With practice, automatic, kneejerk reactions to symptoms are replaced with mindful choices about how best to respond to symptoms. This will lighten the load of living with the symptoms, moving participants in the valued direction of their choosing."
15770829|NCT04688697|Procedure|prepectoral implant-based reconstruction|In this group, patients receive breast reconstruction with prosthesis placed to anterior pectoralis major, synthetic mesh is used to enclose the prosthesis and place it to anterior pectoralis major.
15770830|NCT04688697|Procedure|subpectoral implant-based reconstruction|In this group, patients receive breast reconstruction with placed to posterior pectoralis major, part of the mesh is placed under the pectoralis major during the operation, and the mesh is used to cover the suture of the prosthesis on the inferior plica, or to directly enclose the lower part of the implant.
15770831|NCT04688684|Behavioral|Family-based diet and exercise intervention|The participants will meet together weekly as a family unit to receive education and planning to implement diet and lifestyle changes under the supervision of a health coach. This coach will also be available during the week by telephone or messaging for additional individualized support if needed.
15770832|NCT04688684|Behavioral|Usual care|These age and gender matched patients will undergo usual care with dietician appointments.
15770833|NCT04688671|Drug|ETX-018810|Study Drug
15770834|NCT04688671|Drug|Placebo|Matching Placebo
15770835|NCT04688658|Drug|Nivolumab|Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer.
15770836|NCT04688658|Drug|Duvelisib|Duvelisib is a potent inhibitor of both γ and δ isoforms. Duvelisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
15770837|NCT04688645|Drug|Balanced crystalloid solution|Balanced crystalloid solution (Plasmalyte) given as an initial bolus of 10 ml/kg body weight within the first 60 min after randomization, and then continued at a rate of 2 ml/kg body weight during the next 72 hours. If needed boluses may be repeated.
15770838|NCT04688645|Drug|Normal saline|0.9% sodium chloride solution given as an initial bolus of 10 ml/kg body weight within the first 60 min after randomization, and then continued at a rate of 2 ml/kg body weight during the next 72 hours. If needed boluses may be repeated.
15770839|NCT04688632|Drug|Ampreloxetine <Dose A>|Ampreloxetine <Dose A> will be administered as 1 tablet of <Dose A> and 3 tablets of Ampreloxetine Placebo.
15770840|NCT04688632|Drug|Ampreloxetine <Dose B>|Ampreloxetine <Dose B> will be administered as 4 tablets of <Dose A>
15770841|NCT04688632|Drug|Ampreloxetine Placebo|Ampreloxetine Placebo will be administered as 4 tablets of placebo. The placebo tablet will match (in appearance) the ampreloxetine <Dose A> tablet.
15770842|NCT04688632|Drug|Moxifloxacin|Moxifloxacin will be administered orally as a single tablet.
15770843|NCT04688632|Drug|Moxifloxacin Placebo|Moxifloxacin placebo will be administered orally as a single tablet. The placebo tablet will match (in appearance) the moxifloxacin tablet.
15770844|NCT04688619|Behavioral|"Prevention Program young In Favor of Myself, active parents"|"Prevention program: young In Favor of Myself, with parent participation"
15770845|NCT04688619|Behavioral|"Prevention Program young In Favor of Myself, no parental involvement"|"Prevention program: young In Favor of Myself, without parent participation"
15770846|NCT04688606|Diagnostic Test|Circulating tumor cell capture technology|CTCBIOPSY® automatic testing platform
15770847|NCT04688593|Device|MobileLink|Patients who receive a MobileLink hip prosthesis system will be followed-up for 10 years.
15770849|NCT04688567|Behavioral|Patient-driven iCBT|1) Participants who are randomized to the experimental condition are asked to make choices regarding the structure of their treatment by the time of the randomization call. The participant can choose which of the available treatment programs (targeting anxiety, worry, stress, sleep disorders or depression) they want to undergo, how many modules in the treatment program they want to complete and in what order, for how many weeks they want to complete the treatment as well as how much telephone contact and how much written contact they want to have with their therapist.
15770850|NCT04688567|Behavioral|Standardized iCBT (TAU)|2) Patients who are randomized to the control condition (standardized iCBT) undergo the usual iCBT program available for anxiety disorders for 8 weeks. The psychologist provide weekly feedback on the patient's exercises and interact with the patient via secure encrypted messages in the treatment program. A follow-up telephone call takes place at the middle of treatment and at the end of the treatment.
15770851|NCT04688554|Diagnostic Test|fMRI and DTI|Neurologic imaging correlates
15770852|NCT04688554|Behavioral|Behavioral questionnaires|RAND 36-item Quality of Life survey, Mini Mental Status Exam, MOCA Cognitive Exam
15770853|NCT04688554|Behavioral|Disease-Specific Patient-Reported Outcomes|Y-BOCS Survey, QUEST, PDQ39, PHQ2 Depression Screening, PHQ9 Depression Inventory, Beck's Depression Inventory, PROMIS Pain Intensity Short Form 3, McGill Pain Scale, Visual Analog pain scale, FTM (Tremor Scale)
15770854|NCT04688554|Behavioral|Behavioral tests|Behavioral tests may include one or more of the following procedures: Upper extremity testing, Perdue Peg Board testing, Hand tactile detection and discrimination test, Temperature and pain threshold testing, Lower extremity Testing, Myomotion Inertial Motion Testing.
15770855|NCT04688541|Device|Optitip Catheter (LinC Medical)|The Optitip catheter, unlike the Foley catheter design which has a protruding tip, the Optitip has a blunt open end (eyelet) that protrudes slightly beyond a single fluid-filled 10ml balloon. It has an additional drainage eyelet underneath the balloon.
15770856|NCT04688541|Device|Foley catheter|Foley catheter
15770857|NCT04688528|Radiation|Dose de-escalation and / or Volume de-escalation|The dose de-escalation and/or volume de-escalation strategy will be individually adapted in function of the draining pattern of sentinel lymph nodes on the contralateral side of the neck.
15770858|NCT04688515|Behavioral|Nutrition program developed using positive deviance approach|It is a 3-month nutrition program including nutrition education session and rehabilitation session. The education session consists of half hour education lesson and one and half hours peer-led cooking session. The cooking demonstration will be led by volunteers from PD family. Participating mothers will need to bring along their children during this session, prepare meal according to pre-planned menu and feed their children with the prepared meal after cooking as snack or additional meal. The rehabilitation session will be the rest of the days following each education session until the next education session. Growth monitoring session will also be conducted in each session, whereby mothers will be taught and trained to weigh their children.
15770861|NCT04688489|Dietary Supplement|Carbloading and maltodextrin|The intervention is a dietary intervention that consists of a supplement of maltodextrin and added dietary carbohydrates. The supplement (20 g for women and 30 g for men) will be given to patients before and after a scheduled training, while the carbohydrates are given with meals. The extra carbohydrates given at meal time consists of extra potatoes, rice, bread, fruit, juice or other carbohydrate-rich food items.
15770862|NCT04688450|Device|VIGORIS Blood Pressure Management Clinical Decision Support System|Software system to optimize tight blood pressure management during vasopressor infusion
15770863|NCT04688437|Radiation|standard standing-sitting posteroanterior and lateral whole spine X-ray and lumbar MRI examination|Routine examination
15770864|NCT04688424|Device|FES|FES will be applied via surface electrodes placed over bilateral quadriceps muscles. FES-stimulation will be ramped from sensory level (the level at which the individual feels a cutaneous sensation from the stimulation) to the maximum-tolerated level using a closed loop system controlled by computer software Subjects will exercise at home, three times per week, with FES on for 8 weeks with a goal of attaining 30 minutes of continuous cycling per session. If the individuals are unable to cycle for 30 continuous minutes, rest breaks will be provided with a goal of cycling for a total of 30 minutes. The length of each session will be approximately 45 minutes, with 15 minutes of set-up and 30 minutes of cycling.
15770865|NCT04688424|Other|Cycling|Subjects will exercise at home, three times per week, without FES for 8 weeks with a goal of attaining 30 minutes of continuous cycling per session. If the individuals are unable to cycle for 30 continuous minutes, rest breaks will be provided with a goal of cycling for a total of 30 minutes. The length of each session will be approximately 45 minutes, with 15 minutes of set-up and 30 minutes of cycling.
15770866|NCT04688411|Behavioral|MED-Go App|A novel multifunctional mobile app (MED-Go) to improve adherence to hydroxyurea in patients with sickle cell disease
15770867|NCT04688398|Dietary Supplement|Seal oil|Consumption of seal oil once per day (at breakfast)
15770868|NCT04688398|Dietary Supplement|Control|Consumption of vegetable oil once per day (at breakfast)
15770869|NCT04688385|Biological|Multipeptide Vaccine+ XS15|Peptide vaccination will take place in CLL patients that achieved at least a partial remission with detectable MRD after at least 6 and less than 9 months of an ibrutinib-based treatment regime. MRD will be determined by flow cytometry. MRD positivity is defined as > 10-4 CLL cells in peripheral blood or bone marrow. Patients will receive either ibrutinib monotherapy or combinational therapy before study treatment. Vaccination will be done under ibrutinib monotherapy (i.e. after the end of e.g. anti-CD20 treatment, if applicable).
15770870|NCT04688372|Other|Surge Index|See study description above
15770871|NCT04688359|Behavioral|Guided Self Determination|Nurse lead intervention in primary care
15770872|NCT04688346|Drug|HemeRX epinephrine pellets|Racemic Epinephrine Pellet
15770873|NCT04688333|Other|Internet-Based Intervention - Complete iConquerFear program|Online adaptation of a highly effective face-to-face treatment for fear of recurrence.
15770874|NCT04688333|Other|Quality-of-Life Assessment|Ancillary studies
15770875|NCT04688333|Other|Questionnaire Administration|Complete questionnaires
15837213|NCT04147260|Drug|Ciprofloxacin|Film-coated tablet
15770876|NCT04688320|Drug|Recombinant nonimmunogenic staphylokinase|15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds
15770877|NCT04688320|Drug|Alteplase|Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.
15770879|NCT04688294|Drug|Sacubitril-Valsartan|Study participants initially received Sacubitril/Valsartan at 49 mg/51 mg twice daily orally then dose was doubled as tolerated every 2-4 weeks to reach the target maintenance dose 97 mg/103 mg twice daily
15770880|NCT04688281|Device|Medicurtain®|Medicurtain® 5ml prefilled syringe
15770881|NCT04688281|Device|GUARDIX-SG®|GUARDIX-SG® 5ml prefilled syringe
15770882|NCT04688268|Drug|deep neuromuscular blockade|Train of Four=0/4, Post tetanic count 1-2
15770883|NCT04688255|Behavioral|MSTEP|Aerobic exercise that is advanced weekly
15770884|NCT04688255|Behavioral|Stretching|Stretching exercises that are advanced weekly
15770885|NCT04688242|Other|Anal dilatation per anus|Digital anal dilatation through anastomosis, with concomitant administration of probiotics per anus
15770886|NCT04688242|Drug|administration of probiotics (Clostridium butyricum TO-A; Bacillus mesentericus TO-A; Streptococcus faecalisT-110) per anus|Digital anal dilatation through anastomosis, with concomitant administration of probiotics per anus
15770887|NCT04688229|Device|Hummingbird hand training device plus standard of care rehabilitation|The Hummingbird is a comprehensive hardware and software platform that isolates the hand, wrist, and forearm in a neutral and comfortable position, allowing linear force and angular torque to be measured at the finger-tips between 0-10 Newtons at milli-newton resolution at 100 Hz per digit, in 5 degrees of freedom simultaneously, in real-time, for all 5 digits. The platform allows isolating and characterizing fine resolution forces with sufficient sensitivity and resolution to record data in severe paralysis. The platform also comprises therapeutic software to train exploratory, individuated, and inter-digit complex finger movements by coupling force and torque output to NeuroAnimation physics-based virtual interface in engaging therapeutic experiences.
15770888|NCT04688229|Other|Comparison (sham) intervention|During each hour of sham therapy the therapist will select cognitive tasks (e.g. puzzles and games) targeted to a level of difficulty based on the subjects ability. No grasping or object manipulation using the target upper limb will be included in this intervention. Rather, the participant will use either the unaffected limb (or non-targeted limb for SCI subjects) as needed for any particular puzzle or game.
15770889|NCT04688216|Other|risk factors of infection with multidrug-resistant organisms|"General information: age, gender, length of stay in ICU, method of admission, tubes taken at the time of admission, APACHEⅡ score, surgery, laboratory tests (PCT, CRP, WBC), pressure sores, etc.
~Iatrogenic factors: days of using ventilator, days of using antibacterial drugs, types of antibacterial drugs, use of glucocorticoids, use of immunosuppressants, days of central venous intubation, days of indwelling catheters, days of arterial catheterization, and other indwelling catheters.
~The patient's own related factors: diagnosis, whether complicated with hypertension or diabetes; whether exist malignant tumor, primary lung infection, hypoproteinemia; whether antibiotic treatment before admission; fever and fever days, whether diarrhea occurs"
15770890|NCT04688203|Drug|Magnesium Sulfate Injection|will receive IV bolus dose of 40mg/kg magnesium sulfate in 100 ml saline solution over ten minutes then continuous infusion of 10-15mg/kg/h will be titrated till achieve target mean arterial blood pressure (55-65 mmHg) and will be terminated by the end of surgery.
15770891|NCT04688203|Drug|Labetalol Injectable Solution|will receive IV bolus does of labetalol 0.25 mg/kg over ten minutes then continuous infusion of 0.5-1mg/kg/h will be titrated till achieve target mean arterial blood pressure (55-65 mmHg) and will be terminated by the end of surgery.
15770892|NCT04688177|Device|Body Composition|The subjects should lie in the supine position on a non-conducting surface for 5 min. 4 surface electrodes with cables will be attached to the right hand and ankle of subjects.
15770893|NCT04688177|Device|Heart rate variability|After supine quietly for 20 min, a lead I electrocardiogram will be taken for 5 min.
15770894|NCT04688177|Device|Grip Strength|The participants will squeeze the hand dynamometer as hard as possible with the dominant hand. 3 successive measurements will be taken.
15770895|NCT04688177|Device|Exhale Carbon Monoxide Concentration|Subjects in sitting position, performing 1 inspiration, then exhale to carbon monoxide meter.
15770896|NCT04688177|Device|Pulmonary Function Test|Subjects should be in a sitting position with a nose clip, then perform pulmonary function test. Participants should perform at least 3 acceptable attempts, but no more than 8 attempts in total.
15770897|NCT04688177|Device|Respiratory Muscle Function|Subject will perform both maximal inspiratory pressure and maximal expiratory pressure for 3 times in sitting position with the nose clip.
15770898|NCT04688177|Behavioral|Fagerström Test for Nicotine Dependence|Fagerström Test for Nicotine Dependence Traditional Chinese version will be adopted. It is a 6-item questionnaire that could help quantify the smoking frequency, amounts, and level of dependence.
15770899|NCT04688177|Behavioral|Seven-Day Physical Activity Recall Questionnaire|Physical activity will be measured by the Chinese Version of the Seven-Day Physical Activity Recall Questionnaire. Participants will need to recall the time (hours) they spent in various leisure activities in the past 7 days.
15770900|NCT04688177|Device|Cardiopulmonary exercise testing|Bruce protocol as the treadmill evaluation protocol will be adopted for cardiopulmonary exercise testing.
15770901|NCT04688164|Drug|REL-1017|REL-1017 tablet
15770902|NCT04688164|Drug|Placebo|Placebo tablet
15770903|NCT04688151|Drug|Rituximab|Dose level 1:Rituximab 375mg/m2 infusion once every 4 weeks for 8 cycles Acalabrutinib 100mg PO once every day Durvalumab 1500mg infusion once every 4 weeks Dose level 2:Rituximab 375mg/m2 infusion once every 4 weeks for 8 cycles Acalabrutinib 100mg PO twice every day Durvalumab 1500mg infusion once every 4 weeks Expansion:Determined by the result of the dose escalation phase
15770934|NCT04687891|Diagnostic Test|transabdominal ultrasound and transvaginal ultrasound|Within a week before scheduled delivery,antepartum transabdominal and transvaginal ultrasound will be performed with moderately full bladder.
15770935|NCT04687878|Drug|Insulin|20 IU twice a day, intranasally, every day for 12 weeks
15770904|NCT04688086|Diagnostic Test|Thermalytix|Thermalytix is an Artificial intelligence based automated breast screening solution that analyzes thermal distribution on the breast to generate a breast health score automatically. Thermal imaging was performed by a trained technician to capture thermal images of the participant in five views. These thermal images were uploaded to Thermalytix software on the cloud where it was automatically analyzed by AI-based Thermalytix computer-aided detection (CADe) engine. This CADe engine analyzes uploaded thermal images and outputs an interpretation report for each participant with quantitative scores corresponding to computed probability of malignancy based on the structural, vascular, areolar, thermal properties of the observed abnormality. Thermalytix also generates annotated images with markings of abnormal regions and an overall Thermalytix score suggesting likelihood of breast malignancy. The locked AI model Thermalytix algorithm version 3, dated December 2018 was used for the analysis.
15770905|NCT04688073|Behavioral|Exercise|Running
15770906|NCT04688073|Behavioral|Rest|sit and rest
15770907|NCT04688060|Diagnostic Test|Falls Efficacy Scale-International (FES-I)|The FES-1 was used to assess the fear of falling level of participants about falling during indoor or outdoor activities. It has 16 items scored on a four-point Likert scale. The Turkish validated version of the FES-I was used in this study. The total score (sum of the 16 responses) ranging from 16 to 64 points was used for data analysis. A higher score indicates better mobility performance. A cut-off score of 27 points on the 16- item FES-I was used to differentiate high concern for falling from low concern
15770908|NCT04688047|Behavioral|Nursing care based on the transtheoretical model|Nursing care consists of urinary incontinence training, motivational interview and telephone/mail counseling processes.
15770909|NCT04688034|Drug|OP-724|Twice a week for 4 hours continuous intravenous administration of OP-724.
15770910|NCT04688021|Drug|Cytarabine|4 mg/m2/day administered IV day -10 through -9.
15770911|NCT04688021|Drug|Busulfan|3.2 mg/kg/day administered IV day -8 through -6.
15770912|NCT04688021|Drug|Cyclophosphamide|1.8 g/m2/day administered IV day -5 through -4.
15770913|NCT04688021|Drug|Me-CCNU|250mg/m2 once administered orally on day -3.
15770914|NCT04688021|Drug|Rabbit antithymocyte globulin|1.5mg/kg/day administered IV day -5 through -2.
15770915|NCT04688021|Drug|Tocilizumab|8mg/kg administered IV on day -1.
15770916|NCT04688021|Procedure|Allogeneic HSCT|Day 0
15770917|NCT04688021|Drug|Cyclosporin A|2.5 mg/kg/day administered intravenously from day -7, target: 200-300ng/mL. Usually tapered during the second month, and ended in complete withdrawal during the ninth month after transplantation.
15770918|NCT04688021|Drug|Mycophenolate Mofetil|500 mg/day administered intravenously from day -9, ended in complete withdrawal on day +100.
15770919|NCT04688021|Drug|MTX|15 mg/m2 administered intravenously on day +1, 10mg/m2 on day +3, +6, and +9.
15770920|NCT04688008|Drug|Hetrombopag|"Drug: Early phase hetrombopag olamine formulation single oral dose of 5 mg hetrombopag under fasting conditions
~Drug: Late phase hetrombopag olamine formulation single oral dose of 5 mg hetrombopag under fasting conditions"
15770921|NCT04687995|Procedure|Endoscopic myringoplasty|Endoscopic myringoplasty by using two different grafts one each time
15770922|NCT04687982|Biological|modified donor lymphocytes infusion (mDLI)|"The planned number of mDLI is 3.
~Day +50 (+/- 7 days) from allogenic transplant, 1st mDLI 5x105CD3+/kg of recipient.
~4-6 weeks after 1st DLI, 2nd mDLI 1x106CD3+/kg of recipient.
~4-6 weeks after 2nd DLI, 3rd mDLI 5x106CD3+/kg of recipient."
15770923|NCT04687969|Drug|[18F]DCFPyL|will be administered by intravenous injection by bolus by a qualified nuclear medicine technician
15770924|NCT04687969|Radiation|PET/MRI scanner|PET/MRI Scan with [18F]DCFPyL as directed by protocol
15770925|NCT04687956|Procedure|LYMPHA|Axillary reverse mapping is performed before surgery, axillary lymph node resection is performed, and 'LYMPHA' (Lymphatic microsurgical preventing healing approach) is performed, and the surgery is terminated. Subsequently, the occurrence of lymphedema is followed up.
15770926|NCT04687956|Procedure|control|In the control group, axillary lymph node resection is performed and the surgery is terminated without additional procedures. Subsequently, the occurrence of lymphedema is followed up.
15770927|NCT04687943|Combination Product|PELOID therapy, kinesio tape, exercise|126 patients diagnosed with lateral epicondylitis will be divided into 3 groups. Totally 15 sessions of peloid therapy for 42 patients in 1 group for 3 weeks, 5 days a week, 2 sessions of muscle and fascia correction techniques for 3 weeks in the second group for 3 weeks, and 3 sets per day for 42 patients in the third group for 3 weeks. You will be given 10 repetitive home workouts.
15770928|NCT04687930|Drug|genicular nerve block|nerve block of the genicular nerve at 3 points around the inflamed knee using ultrasound.
15770929|NCT04687930|Drug|intra-articular steroid injection|Triamcinilone injection into the knee joint under ultrasound guidance.
15770930|NCT04687917|Behavioral|The facilitation, training, feedback, and consultation (FTFC) Strategy|A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, and consultation
15770931|NCT04687917|Behavioral|The facilitation, training, feedback, consultation, and pay-for-performance (FTFC+PFP) Strategy|A multilevel implementation strategy that includes team-focused facilitation, as well as staff-focused training, feedback, consultation, and pay-for-performance.
15770932|NCT04687904|Behavioral|Mindfulness meditation training|Patients will be able to benefit from mindfulness meditation training at the rate of 1h30 in the morning and 1h30 in the afternoon. During this training, patients will be invited to share with the psychologist their vision of mindfulness meditation and their expectations of this practice. The psychologist will then introduce what mindfulness is and how the sessions will take place. Several sessions guided by the psychologist will then be offered to the patient (body scan, focused attention, mindfulness movements...).
15770933|NCT04687904|Behavioral|Therapeutic education|"Patients will benefit from a 2-hour interview which will be conducted by the psychologist associated with the project.
~The aim of this interview is to help patients better understand their disease in order to adopt the right behaviors on a daily basis. This session will inform patients about their disease, its origins, its treatment, the difficulties it causes and the means to remedy it. The objective of this session is to better understand and manage epilepsy and to enable patients to take an active part in the process of care and management of the disease.
~No specific instructions will be given at the end of this interview."
15770936|NCT04687878|Drug|Normal saline|twice a day, intranasally, every day for 12 weeks
15837214|NCT04147247|Drug|BI 905681|Infusion
15770937|NCT04687865|Other|Biobank|"For each patient included in the study the following samples will be collected at the indicated time points after transplantation:
~Serum samples and plasma sample: Day1, Month 1, Month 3, Month 6, Month 12, month 60, month 120 and at the time of each allograft biopsy.
~Urines samples: Month 3 and Month 12 and at the time of each allograft biopsy.
~Peripheral Blood Mononuclear Cell (PBMC): for each organ allograft biopsy.
~Allograft biopsies: systematically at Month 3, and Month 12, and for cause in case of allograft dysfunction."
15770938|NCT04687852|Other|Conservative and Non-conservative treatments|This program includes Focused Pelvic Floor with Motor Imagery Technique Group ,Nonsteroidal Anti-Inflammatory Drug Group, Diosmin Group, Acupressure Group (LI-4 (Bilateral), CV-6, CV-4, SP-6 (Bilateral). It is aimed to determine the most effective treatment among these groups.
15770939|NCT04687839|Procedure|Induction of suction blister|For each subject, 2 superficial wounds will be made on the inner aspect of each forearm using the suction blister model.
15770940|NCT04687839|Other|Transepidermal water loss (TEWL)|"At V1, before blister suction use (T0) and after blister withdrawal before product application (T1)
~For subsequent visits, before product application"
15770941|NCT04687839|Other|Macrophotography|"At V1, before blister suction use (T0) and after blister withdrawal before product application (T1)
~For subsequent visits, before product application"
15770942|NCT04687839|Device|Wound healing medical device|Twice daily application on superficial wounds
15770943|NCT04687826|Other|Goal directed fluid therapy|Patients in 2015 got intraoperative fluid therapy in goal directed fluid therapy technique.
15770944|NCT04687826|Other|Liberal fluid therapy|Patients in 2017 got liberal intraoperative fluid therapy influenced by their anaesthesiologist.
15770945|NCT04687813|Drug|Placebo|Placebo is a tablet with the same appearance as FTP-198
15770946|NCT04687800|Drug|Dextenza 0.4mg intracanalicular Insert|intracanalicular insert delivery system
15770947|NCT04687800|Drug|Durezol 0.05% Ophthalmic Emulsion|Standard therapy, topical steroid drop
15770948|NCT04687787|Other|Core Stabilization exercises|. Each session will be given for 40 mins (20 mins for TENS and 20 Mins for exercise) Core Stability Exercises include Kegel Exercises, Modified V-sit, opposite Arm Leg Raise, Seated Side bends poses, Dumbell Side bends and Pelvic Tilt. Participants will perform 1 set of exercise having 10 repetitions with hold of 5 seconds. Session would be performed thrice a week.
15770949|NCT04687787|Other|Routinely prescribed exercises|Each session will be given for 40 mins ( 20 mins for TENS and 20 Mins for exercise Routinely prescribed exercises composed of Hamstring stretches, hip flexor stretches, hip extensor stretches, calf stretches, and back extensor stretches. Participants will perform 1 set of exercise having 10 repetitions with hold of 5 seconds. Session would be performed thrice a week.
15770951|NCT04687761|Drug|Azacitidine|AZA 75 mg/m2/daily SC days 1 to 7 or on a 5-on/2-off [weekend]/2-on schedule in 28-day cycle
15770952|NCT04687761|Drug|Venetoclax|Venetoclax (ramp-up) 400 mg/daily oral days 1 to 28
15770953|NCT04687761|Drug|Quizartinib|Quizartinib 40 mg/daily oral, days, 8 to 28
15770954|NCT04687761|Drug|Cytarabine|Low-dose subcutaneous cytarabine (LDAC) 20 mg/m2/daily SC, days 1 to 10
15770955|NCT04687761|Drug|Venetoclax|Venetoclax (ramp-up) 600 mg/daily oral, days 1 to 28
15770956|NCT04687761|Drug|Quizartinib|Quizartinib 40 mg/daily oral, days 8 to 28
15770957|NCT04687748|Device|Electromographic Biofeedback|Surface EMG biofeedback is an adjunct therapy to standard exercise regime for increasing muscle strength. Electromyographic biofeedback is a specific form of biofeedback. The device records muscle activity through application of vaginal probe will be inserted in vagina and the reference surface electrode would be placed over the right anterior superior iliac spine.
15770958|NCT04687748|Other|PFM exercises|Patients would be advised to maximally contract the pelvic floor muscles as forcefully a possible for about 5 seconds. Three attempts would be made with 40 seconds rest in between each contraction. The exercises would be performed with the patient initially in supine position, with hip and knee flexed at 30 and 90 degrees.
15770959|NCT04687735|Other|Intervention after nerve block|Brachial plexus block + Physical therapy
15770960|NCT04687722|Other|High Intensity Aerobic Training.|Participants will perform 2-5 minutes of low to moderate intensity warm up exercises and then 20 minutes of high intensity aerobic training at 80-90% of heart rate maximum increased gradually on treadmill and elliptical trainer and then 2-5 minutes of low to moderate intensity cool down exercises.
15770961|NCT04687722|Other|Low intensity Aerobic Training|Participants will perform 2-5 minutes of low to moderate intensity warm up exercises and then 20 minutes of low intensity aerobic training at 40-60% of heart rate maximum increased gradually on elliptical trainer and jogging and then 2-5 minutes of low to moderate intensity cool down exercises.
15770962|NCT04687696|Other|Post Isometric Relaxation Group|Athletes will be positioned in a modified cross-body position. They will be asked to actively bring their underlying arm in the direction of horizontal adduction up to the physiological barrier barrier. The participants will be asked to perform an isometric contraction for 5 seconds in the horizontal abduction direction with 20% of the maximum muscle strength. After the relaxation, the arm will be moved towards horizontal adduction and 15 seconds active-assistive stretching will be applied. Participants will be given a 5-second rest period between contractions.This stretching exercise will be applied in 5 repetitions in one session for 6 weeks 5 times a week.
15770963|NCT04687696|Other|Isolytic Stretching Group|Athletes will be positioned in a modified cross-body position. They will be asked to actively bring their underlying arm in the direction of horizontal adduction up to the physiological barrier barrier. The participants will be asked to perform a contraction in the horizontal abduction direction with 20% of the maximum muscle strength. When the muscle contraction occurs, the arm will be moved quickly in 2-4 seconds towards horizontal adduction and 15 seconds active-assistive stretching will be applied. Participants will be given a 5-second rest period between stretches. This stretching exercise will be applied in 5 repetitions in one session for 6 weeks 5 times a week.
15771010|NCT04687306|Diagnostic Test|X-rays- total of 4|X-rays of the sacral scope, pelvic femoral angle and cup ante-inclination in both sitting and standing positions
15771071|NCT04686812|Behavioral|Worksite health promotion program|Physical activity, nutrition, and stress management programs
15770964|NCT04687696|Other|Static Stretching Group Group|Athletes will be positioned in a modified cross-body position. They will be asked to actively bring their underlying arm in the direction of horizontal adduction up to the physiological barrier. Then, the arm will be moved towards horizontal adduction and 15 seconds active-assistive stretching will be applied. Participants will be given a 5-second rest period between stretching exercises. This stretching exercise will be applied in 5 repetitions in one session for 6 weeks 5 times a week.
15770965|NCT04687683|Other|Post Isometric Relaxation Group|Athletes will be positioned in a modified cross-body position. They will be asked to actively bring their underlying arm in the direction of horizontal adduction up to the physiological barrier barrier. The participants will be asked to perform an isometric contraction for 5 seconds in the horizontal abduction direction with 20% of the maximum muscle strength. After the relaxation, the arm will be moved towards horizontal adduction and 15 seconds active-assistive stretching will be applied. Participants will be given a 5-second rest period between contractions. This stretching exercise will be applied in 5 repetitions for one session.
15770966|NCT04687683|Other|Isolytic Stretching Group|Athletes will be positioned in a modified cross-body position. They will be asked to actively bring their underlying arm in the direction of horizontal adduction up to the physiological barrier barrier. The participants will be asked to perform a contraction in the horizontal abduction direction with 20% of the maximum muscle strength. When the muscle contraction occurs, the arm will be moved quickly in 2-4 seconds towards horizontal adduction and 15 seconds active-assistive stretching will be applied. Participants will be given a 5-second rest period between stretches. This stretching exercise will be applied in 5 repetitions for one session.
15770967|NCT04687683|Other|Static Stretching Group Group|Athletes will be positioned in a modified cross-body position. They will be asked to actively bring their underlying arm in the direction of horizontal adduction up to the physiological barrier. Then, the arm will be moved towards horizontal adduction and 15 seconds active-assistive stretching will be applied. Participants will be given a 5-second rest period between stretching exercises. This stretching exercise will be applied in 5 repetitions for one session.
15770968|NCT04687670|Diagnostic Test|ERA|Before the randomization, Endometrial Fluid (EF) and Endometrial Biopsy (EB) samples will be collected from all participants. EF will be obtained by aspiration immediately prior to the EB after around 120 hours of progesterone (P) impregnation following the standard HRT cycle. The results of the ERA test will be provided to participants and their gynecologists for the personalized embryo transfer.
15770969|NCT04687670|Diagnostic Test|ERA|Before the randomization, Endometrial Fluid (EF) and Endometrial Biopsy (EB) samples will be collected from all participants. EF will be obtained by aspiration immediately prior to the EB after around 120 hours of progesterone (P) impregnation following the standard HRT cycle. The results of the diagnosis will not be disclosed with the patients randomized into this arm nor with their gynecologists.
15770970|NCT04687657|Drug|umbilical cord blood|During the consolidation chemotherapy stage, the umbilical cord blood transfusion is given twice (interval of 1 month) to support treatment. On the first day after umbilical cord blood transfusion, the proportion of NK cells in peripheral blood is detected. If it is less than 20%, the NK cells sre activated by subcutaneous injection of recombinant human interleukin-2 (rhIL-2) on the second day after infusion.
15770971|NCT04687644|Behavioral|Online education|Education group
15770972|NCT04687631|Drug|mFOLFOXIRI plus Cetuximab|cetuximab 500mg/m2 + oxaliplatin 85 mg/m2 + irinotecan 165 mg/m2 + folinic acid 400 mg/m2 + 5-fluorouracil 2400 mg/m2 46h infusion starting on day 1, every 2 weeks
15770973|NCT04687631|Drug|mFOLFOXIRI Plus Bevacizumab|bevacizumab 5mg/kg + oxaliplatin 85 mg/m2 + irinotecan 165 mg/m2 + folinic acid 400 mg/m2 + 5-fluorouracil 2400 mg/m2 46h infusion starting on day 1, every 2 weeks
15770974|NCT04687618|Device|High Flow Nasal Cannula withAutomatic control of FiO2 using OAM|The target oxygen saturation (SpO2) value will to be determined and set by the clinician according to specific patient needs. The target SpO2 in preterm infants is 90-95% with alarm limits at 89-96%. In automatic control of oxygen, the OAM automatically increases or decreases the FiO2 (oxygen delivery) setting on the Vapotherm Precision Flow based on pulse oximetry readings of the OAM. The target saturation will be set at 93% and the FiO2 will be adjusted by OAM to maintain the target saturation. The automated FiO2 setting can be overridden for a clinician pre-set period of time (30-120 sec) by simply manually adjusting the FiO2 on the Precision Flow. Automated control resumes after the clinicians pre-set period of time (30-120 sec) based on the current SpO2 and FiO2. The OAM utilizes a feedback control algorithm that receives a patient's oxygen saturation value from a build in pulse oximetry device (Masimo SET OEM - normal sensitivity, averaging time window set at 8 seconds).
15770975|NCT04687618|Device|High Flow Nasal Cannula with manual control of FiO2|In manual control of oxygen all FiO2 adjustments will be done by the clinical staff to maintain saturations between 90-95%. The alarm limits will be 89-96%.
15770976|NCT04687605|Procedure|Temporary hypercapnia|Temporary daily hypercapnia for 2 hours between day 4 and 14 after SAH
15770977|NCT04687592|Procedure|reduction and fixation|"Reduction: one trial of closed reduction under anaesthesia and image control. Open reduction will be done by anterolateral or lateral approach if closed reduction failed
~Fixation: internal fixation of the fracture by appropriate implant according to the fracture state"
15770978|NCT04687579|Other|Screening|Screening: All health professionals at the hospitals will participate in the screening of umbilical hernia. The screening will be done in the outpatient clinic, the Emergency Department and at the hospital wards.
15770979|NCT04687579|Procedure|Preoperative optimization|Ascites will be drained using percutaneous drainage or PleurX. Diuretics be used to control ascites preoperative. Haemoglobin < 5 mmol/L indicates the need for red blood cell concentrates using two dosage SAG-M (350-400 mL of red blood cell concentrates in each dose) will be done. Thrombocytopenia < 150 10^9/L will be treated with a TPO-analog using avatrombopag 40-60 mg dispensed as an intravenous fluid. Culture verified infection will be treated with specific antibiotics depending on the blood culture. International Normalized Ratio > 1.7 will be treated with either phytomenadion, Octaplex or fresh frozen plasma depending on the INR.
15771039|NCT04687059|Biological|PQ Grass|Suspension for injection
15771040|NCT04687059|Drug|Placebo Option 1|Suspension for injection
15771041|NCT04687059|Drug|Placebo Option 2|Solution for injection
15771042|NCT04687046|Device|JUVÉDERM VOLUX®|JUVÉDERM VOLUX® injectable gel
15771072|NCT04686799|Drug|Doxycycline Hyclate 20 MG|Subjects will receive doxycycline 20 mg BID
15773363|NCT04668066|Drug|PF-07242813|PF-07242813 given intravenously or subcutaneous
15770980|NCT04687579|Procedure|Umbilical hernia repair|A curved incision placed superiorly or inferiorly around the umbilicus. The umbilicus proper is retained in the skin flap. The blunt dissection is made to the hernia sac. The neck of the herniated sac is then dissected from adjacent tissues by a combination of blunt and sharp dissection. The edges of the fascial defect are measured and the fascial defect is closed with a non-absorbable running suture 2-0. A fitted lightweight polypropylene mesh is placed in an onlay fashion and fixed with 4-8 single non-absorbable sutures in the corners and at the midline, with a mesh overlap of at least 4 cm. The umbilicus is re-inserted with a single knot absorbable suture 3-0. Hemostasis is ensured. Skin closure is performed with Nylon suture 3-0. 20 ml bupivacaine 0.5% is injected to the fascia for early pain control.
15770981|NCT04687566|Drug|Dextromethorphan|The participants will take dextromethorphan 60 mg per day, once daily, for 12 weeks. The participants will be blind to the assigned treatment group.
15770982|NCT04687566|Drug|Memantine|The participants will take memantine 5 mg per day, once daily, for 12 weeks. The participants will be blind to the assigned treatment group.
15770983|NCT04687566|Drug|Dextromethorphan and memantine|The participants will take dextromethorphan (60 mg per day) and memantine (5 mg per day) combination, once daily, for 12 weeks. The participants will be blind to the assigned treatment group.
15770984|NCT04687566|Drug|Placebo|The participants will take the placebo pills, once daily, for 12 weeks. The participants will be blind to the assigned treatment group.
15770985|NCT04687553|Diagnostic Test|Simplified Evaluation of CONsciousness Disorders (SECONDs)|All patients were assessed by the Simplified Evaluation of CONsciousness Disorders (SECONDs)
15770986|NCT04687540|Drug|Tocilizumab|Baseline: Tocilizumab (infusion of 8 mg/kg bodyweight or a maximum of 800 mg) will be infused over 60 minutes at the end for the study day, therefore study visit 1 (study day 1) measurements are baseline.
15770987|NCT04687540|Drug|Saline 0.9%|Participants are under influence of tocilizumab since the effect of the drug will last for 4 weeks. Participants will be infused with saline at study visit 2 (study day 21). Placebo to tocilizumab will be saline (NaCl 0.9%) as tocilizumab is a colorless solution and has to be diluted with NaCl 0.9% prior to administration
15770988|NCT04687514|Drug|Dulaglutide|Dulaglutide: first week 1x 1.5mg in 0.5 ml, following 3 weeks 2 x 1.5 mg weekly in 0.5ml each, via Pen s.c.
15770989|NCT04687514|Drug|Placebo|Placebo: first week 1x0.5 ml physiological saline (0.9% sodium chloride) injection s.c. via syringe, following weeks 2x0.5 ml physiological saline (0.9% sodium chloride) injection s.c. via syringe once weekly for 3 further weeks.
15770990|NCT04687501|Device|Virtual Reality|Virtual reality in gynaecological surgery in the pre- and postoperative setting
15770991|NCT04687488|Other|Fluorescein|For droplet visualization, we will use fluorescein, which has been used for many years in medicine for diagnostic purposes and is safe upon topical administration, as a tracer. There are no local or systemic side effects of topical sodium fluorescein (5). Fluorescein is routinely used in the mouth to stain dental plaque (6). Through the lacrimal duct, the nasal cavity is exposed to fluorescein when it is used for ophthalmological purposes (7). Allergic reactions have been described to intravenous injection, which is not part of our trial. In the setting of head-and-neck and otolaryngological surgeries, coating the mouth with fluorescein has been used to quantify droplet spread, to assess for risk of transmission of COVID-19 (8). Hence, fluorescein can be safely applied to nasal and oropharyngeal cavities. We will use a similar approach, coating the nasal cavity, to study droplet spread from the nose during naso-gastric intubation for motility or reflux testing.
15770992|NCT04687488|Other|Particle measurement|Quantification of aerosol will be done using a medical particle counter, as used for hospital safety measurements.
15770993|NCT04687475|Other|Clinical Tool (Mobile Spirometry and Survey)|The clinical tool is a combination of home spirometry measurements and a patient survey measuring patient reported outcomes including the Cystic Fibrosis Respiratory Symptom Diary (CFRSD) and Chronic Respiratory Infection Symptom Score (CRISS©), with permission from the Seattle Quality of Life Group.
15770994|NCT04687462|Device|1-mm thickness variance polyethylene insert total knee arthroplasty system (Exult, Corentec)|TKRA operation undergoing 1-mm thickness variance polyethylene insert total knee arthroplasty system (Exult, Corentec)
15770995|NCT04687449|Dietary Supplement|Curcumin therapy|Clear capsules (made of vegetable cellulose) with turmeric extract (500 mg, 95% curcuminoids), Bioperine (5 mg, improves absorption), and inactive ingredients (microcrystalline cellulose, vegetable magnesium stearate, silicon dioxide).
15770996|NCT04687449|Other|Placebo|Clear capsules (made of vegetable cellulose) with inactive ingredients (lactose monohydrate and food color); the capsules will be matched in size and color of the content to the preparation used in the Curcumin capsule.
15770997|NCT04687449|Other|Standard care|The standard of care for COPD.
15770998|NCT04687436|Device|mechanical cervical ripening|mechanical cervical ripening with a foley catheter or double-balloon catheter
15770999|NCT04687423|Drug|FCN-011|FCN-011 will be given orally in ascending doses starting at 50 mg Q12h or 100mg QD until the maximum tolerated dose or recommended dose is reached.
15771000|NCT04687410|Device|ProControl, MediGlobe|standard 22G FNA needle
15771001|NCT04687410|Device|TopGain, Medi-Globe|novel 22G crown-cut FNB needle
15771002|NCT04687397|Behavioral|Rehabilitation|Multidisciplinary rehabilitation
15771003|NCT04687384|Procedure|Robotic-assisted colectomy|Robotic-assisted colectomy performed by usage of da Vinci Xi robotic technology
15771004|NCT04687384|Procedure|Conventional laparoscopic colectomy|Conventional laparoscopic colectomy
15771005|NCT04687371|Other|Proprioceptive vestibular exercise|To assess effects of proprioceptive vestibular exercises training in patients with peripheral vestibular hypofunctions
15771006|NCT04687371|Other|Standard vestibular rehabilitation exercises|To assess effects of standard vestibular rehabilitation exercises in patients with peripheral vestibular hypofunctions
15771007|NCT04687371|Other|Controlled|First and last measurement will be taken. There will be no intervention. study will include 9 patients.
15771008|NCT04687332|Other|Apheresis therapy by Octo Nova Technology (DIAMED, Cologne, Germany)|One group was treated with IA and the single use tryptophan adsorber, the other group was treated with PE and the Plasmaflow (see above). In total, all patients receive 5 treatments.
15771009|NCT04687319|Biological|bronchial mucus collection|mucus resulting from respiratory physiotherapy sessions for patients with cystic fibrosis or COPD, bronchial aspirations resulting from the bronchial fibroscopy programme
15771011|NCT04687293|Device|HUBER (LPG Systems, France)|The HUBER® device consists of an oval motorized platform, which performs rotating, oscillatory movements with a controlled amplitude and speed. It also comprises, two large handles with force sensors, mounted on a movable column. Its originality is based on its capacity to capture simultaneously the subjects' balance, core stability, core strength and total body strength; and adapt the training accordingly. Indeed, the platform interferes with the balance of the patient who must continually adjust his/her posture by exerting isometric pushing and pulling efforts with the arms. As a result, the device provides postural and muscle adaptation with visual feedback. Due to the constant adaptation of the device, it is thought to enhance muscular strength and improve neuromuscular coordination simultaneously.
15771012|NCT04687280|Other|non interventional|non interventional, study on data
15771013|NCT04687241|Drug|Almonertinib|The initial dose of Almonertinib 110 mg daily can be reduced to 55 mg daily under specific conditions.
15771014|NCT04687241|Drug|Placebo Almonertinib|Placebo Almonertinib
15771015|NCT04687228|Behavioral|More than Muscles (MTM)|"In session 1, the primary activities are: 1) define the ideal body type for men in our culture, 2) discuss the origin and perpetration of the ideal, 3) brainstorm the costs of pursuing the ideal, 4) participate in a verbal challenge during which participants counter the ideal message, and (5) are asked to complete three homework assignments (i.e., a letter to an adolescent boy, a behavioral challenge, and a mirror exposure assignment). In session 2, the primary activities are: 1) reviewing homework, 2) engage in role-plays to counter/discourage pursuit of the ideal, 3) discuss ways to challenge and avoid negative body talk statements, 4) list ways to resist the pressure to pursue this ideal both individually and as a group within the larger community (i.e., body activism), 5) discuss barriers to body activism and strategies to overcome those barriers, and 6) individually select an exit exercise to continue to actively challenge the appearance ideal."
15771016|NCT04687228|Behavioral|Media Advocacy (MA)|MA content generally centers on acknowledging and discussing the role the media has on shaping body image ideals. Session 1: In session 1, similar to MTM, the primary activities will include: (1) describing the ideal body for men in our culture, (2) discussing how the media impacts this ideal, with a particular focus on advertising. Following this, participants will (3) watch a video on how the media influences body image among men, and the consequences of internalizing these messages. Session 2: In session 2, content will continue by further discussion of the video showed in session 1, with participants sharing their reactions. Next, the group discusses the attainability of the ideal as well as discusses other forms of media (e.g., social media) and how it impacts body image.
15771017|NCT04687202|Other|follow up and record|None additional intervention was applied to the subjects.
15771018|NCT04687189|Device|Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine)|Imaging performed by woman on herself with remote healthcare professional (HCP) supervision compared to images taken when same ultrasound is administered in person by HCP. The ultrasound device used is cleared for HCP-supervised use in environments where healthcare is provided by trained HCPs. No changes to the design or manufacture have been made for this study.
15771019|NCT04687176|Drug|Oral Arsenic Trioxide Formulation|"Patients will be recruited to oral arsenic trioxide, all-trans-retinoic acid, ascorbic acid (AAA) based-induction for 42 days. Daunorubicin (50mg/m^2/day for 3 days) will only be used during induction in patients <65 with presenting white blood cell count (WBC) ≥ 10 x 10^9/L. In patients not receiving daunorubicin, hydroxyurea (2-4g/day) if WBC ≥ 5 x 10^9/L within the first 14 days of induction. A reassessment bone marrow aspirate will be performed on day 28 of induction for assessment of morphologic remission.
~Four weeks after the completion of induction phase, all patients, regardless of initial WBC, will receive two cycles of chemotherapy-free AAA consolidation (14 days every 28 days).
~Four weeks after completion of consolidation, all patients will receive 12 cycles of chemotherapy-free AAA maintenance (14 days every 8 week)."
15771020|NCT04687163|Drug|HAIC of 130 mg/m² Oxaliplatin, and 5-fu|Hepatic arterial infusion of 130 mg/m² oxaliplatin,leucovorin and 2400 mg/m² 5-FU
15771021|NCT04687163|Drug|HAIC of 85 mg/m² Oxaliplatin, and 5-fu|Hepatic arterial infusion of 85 mg/m² oxaliplatin,leucovorin and 2400 mg/m² 5-FU
15771022|NCT04687163|Drug|TKI|sorafenib 400mg bid or lenvatinib 12 mg/day (for bodyweight ≥60 kg) or 8 mg/day (for bodyweight <60 kg)
15771023|NCT04687150|Other|Fecal microbiota transplantation|Fecal microbiota transplantation from a tested general donor, frozen and thawed from a fecal bank
15771024|NCT04687150|Other|Colored water|Colored water (placebo)
15771025|NCT04687137|Drug|TAK-743 300 mg|TAK-743 300 mg, subcutaneous injection every 2 weeks
15771026|NCT04687124|Dietary Supplement|Fish oil|Dietary counseling including an oral nutritional supplement (ONS) containing 2.2 g of n-3 fatty acid EPA (Forticare®)
15771027|NCT04687124|Other|standard care|No specified intervention
15771028|NCT04687111|Drug|Sacubitril-Valsartan|Sacubitril-Valsartan is an Angiotensin Receptor blocker and Neprilysin Inhibitor
15771029|NCT04687111|Drug|Valsartan|Valsartan is an Angiotensin Receptor Blocker
15771030|NCT04687098|Drug|Idarubicin|12 mg/m2/day; intravenous, administration at induction phase, days 1 to 3.
15771031|NCT04687098|Drug|Ara-C|"200mg/m2/day, intravenous at induction phase; days 1-7.
~- High dose during consolidation phase. In patients up to 60 years 3g/m2/12hours days 1,3,5, and patients 60 to 70 years: 1.5g/m2/12hours days 1,3,5."
15771032|NCT04687098|Drug|G-CSF|"Administration at induction phase to remission days 1 to 7. G-CSF will not be initiated if the leukocyte count is over 30x10e9/L at diagnosis or will be interrupted if the leukocyte count during treatment arises 30x10e9/L.
~Administration at consolidation phase day 7."
15771033|NCT04687098|Procedure|Allogeneic matched or unrelated donor transplant.|To be performed in patients in the intermediate or adverse risk groups.
15771034|NCT04687098|Procedure|Autologous peripheral blood stem cell transplant|To be considered in patients in the intermediate risk group without an available allogeneic donor and negative measurable residual disease, per center decision.
15771035|NCT04687098|Procedure|Measurable residual disease|To be performed either with molecular monitoring or, if not applicable, by flow cytometry. Pre-stablished cut-off values are defined for decision-making.
15771036|NCT04687085|Other|10 minute mindful meditation recording|10 minute mindful meditation recording
15771037|NCT04687072|Biological|Efgartigimod PH20 SC|Subcutaneous injection with efgartigimod PH20 SC
15771038|NCT04687072|Other|Placebo PH20 SC|Subcutaneous injection with placebo PH20 SC
15771043|NCT04687033|Device|Transcranial direct current stimulation|This instrument will be used to induce post-stroke motor recovery, two different monocephalic montages are typically used to restore excitability in the lesioned hemisphere and to down-regulate excitability of the non-lesioned hemisphere and rebalance Interhemispheric inhibition. each participant will undergo a 20-minute period of tDCS, applied at 2 mA through a pair of saline-soaked surface sponge electrodes (35 cm2).
15771044|NCT04687020|Drug|Viltolarsen|Received during weekly intravenous infusions
15771045|NCT04687007|Behavioral|SMART-ALD|At the beginning of SMART-ALD, a multi-professional team evaluates participant's current health status and develops an individual treatment plan together with the participant. The SMART-ALD intervention offers medical, psychological, and social counseling, as well as a physical fitness and disease-specific nutritional program carried out via video consultation. Thus, scope and intensity of SMART-ALD intervention is initially tailored to individual needs and continuously adapted to changes during intervention.
15771046|NCT04687007|Behavioral|Waiting list|At the beginning of the study, patients of the waiting list (WL) control condition receive one medical consultation via video consultation, including recommendations to contact their local treating physician if necessary. Individuals are instructed not to seek any other medical or psychological treatment for X-ALD symptoms without informing the study staff. All WL patients are guaranteed 6 months of SMART-ALD intervention after a waiting period of 6 months.
15771047|NCT04686994|Drug|ASC 41|Oral tablets
15771048|NCT04686994|Drug|ASC 41 Placebo|Oral tablets
15771049|NCT04686968|Procedure|Greenhouse Technique|First, the high-strength sutures were passed through the teared tendon, and then Crimson duvet procedure was performed on the footprint from the articular margin of the humeral head to the apex of the greater tubercle, followed by a lateral row anchor.
15771050|NCT04686968|Procedure|Microfracture Combined With Suture Bridge Technique|A three-line anchor suture method is used as in the greenhouse technique, except that the position is between the apex of the greater tubercle and the articular surface. After the rotator cuff is sutured, the bone bed beyond the suture point to the outer edge of the greater tubercle is opened with 2.0mm Kirschner wire every 5mm ( Crimson duvet), 1cm in depth, about 6 in total.
15771051|NCT04686955|Drug|Xiao-Xian-Gui-Fu-Tang|The Xiao-Xian-Gui-Fu-Tang includes Xiao-Feng-San 2.0g, Dang-Gui-Yin-Zi 1.2g, Bai-Xian-Pi(Cortex Dictamni Radicis) 0.4g, and Di-Fu-Zi(Fructus Kochiae) 0.5g. The Xiao-Xian-Gui-Fu-Tang will be manufactured, packaged, and labeled by the KO DA Pharmaceutical Company (Taiwan), using good manufacturing practice standards.
15771052|NCT04686942|Diagnostic Test|After sonazoid|0.015ml/mg sonazoid enhanced US to detection of liver metastases.
15771053|NCT04686929|Drug|Lower dose of abatacept|subcutaneous abatacept: 250mg (d-1) , 125mg (d+5, +14, +21, +28, +35, +42, +49, +56) combined with CsA, MTX, MMF.
15771054|NCT04686929|Drug|Higher dose of abatacept|subcutaneous abatacept: 250mg (d-1, +5, +14, +21, +28, +35, +42, +49, +56) combined with CsA, MTX, MMF.
15771055|NCT04686916|Drug|IP2018|Test drug
15771056|NCT04686916|Drug|Placebo|Placebo
15771057|NCT04686903|Procedure|Epiduroscopy treatment|Device Epiduroscop, procedure mecahnical lysis, laser, radiofrequency + drug administration into the epidural space (corticosteroid methylprednisolone acetate 80mg and solution of hyaluronidase 150 I.U. in 10mL of saline) Follow-up: before procedure, 6 months and 12 months after procedure
15771058|NCT04686903|Procedure|Racz catheter epidural procedure|"Device Racz catheter, two procedures during clinical trial observation
~First procedure after enrolment into the study mechanical lysis and drug administration into the epidural space (corticosteroid methylprednisolone acetate 80mg and solution of hyaluronidase 150 I.U. in 10mL of saline)
~Second procedure after 6 months mechanical lysis + drug administration into the epidural space (corticosteroid methylprednisolone acetate 80mg and solution of hyaluronidase 150 I.U. in 10mL of saline)"
15771059|NCT04686903|Procedure|Caudal epidural block|"Technique Caudal epidural block
~Three procedures during clinical trial observation :
~First procedure after enrolment into the study drug administration into the epidural space (corticosteroid methylprednisolone acetate 80mg and solution of hyaluronidase 150 I.U. in 10mL of saline)
~Second procedure after 4 months drug administration into the epidural space (corticosteroid methylprednisolone acetate 80mg)
~Third procedure after 8 months drug administration into the epidural space (corticosteroid methylprednisolone acetate 80mg)"
15771060|NCT04686890|Procedure|erector spinea plane block administered preoperative open nephrectomy|erector spinae plane block applied in this group before open nephrectomy
15771061|NCT04686890|Procedure|intravenous analgesic ( 1 mg/kg tramadol + non-steroid antiinflamatuar paracetamol )drug + 10 mg.kg|intarvenous analgesic administered in this group for analgesia end of the open nephrectomy
15771062|NCT04686877|Procedure|STAPLE|Stereotactic aspiration plus urokinase clot irrigation
15771063|NCT04686864|Behavioral|Support Group for Caregivers|"Engage parents in the community via this support group, so they can be supported by other parents who know the system, can advise them on how to proceed, and empower them to help their children. Parents will learn psychoeducation about eating disorders and how to support their children."
15771064|NCT04686851|Other|Comprehensive Geriatric Assessment and follow-up|"All patients will receive standardized oncological treatment according to national guidelines. For patients randomized to the intervention arm, a full Comprehensive Geriatric Assessment (CGA) and corresponding interventions on identified health issues will be performed alongside oncologic treatment. The domains are assessed using validated tests based on a Danish version of the Geriatric Core Dataset (G-CODE). The domains are cognition, mood, comorbidity, functional status, physical status, polypharmacy, nutrition, fall risc and social support. The CGA will be performed by the PhD-student (geriatric resident) or a geriatrician together with geriatric nurses at the Department of Geriatric Medicine, OUH. Nutritional status and interventions are assessed by a dietician. A physical therapist will evaluate the physical performance as part of the CGA.
~Follow-up on initial treatment plan is scheduled to one month after baseline CGA."
15771065|NCT04686838|Behavioral|READyR II: A|Continuous monitoring for anomaly detection and contact phone call when a potential change in care needs is indicated by an anomaly.
15771066|NCT04686838|Behavioral|READyR II: B|Sensors will remain in the home but anomaly detection analysis will not be performed and contact phone calls will be at regular intervals without dynamic tailoring content.
15771067|NCT04686825|Drug|DA-8010 2.5mg (Fasting)|Test drug l : DA-8010 2.5mg (Fasting)
15771068|NCT04686825|Drug|DA-8010 2.5mg (Fed)|Test drug ll : DA-8010 2.5mg (Fed)
15771069|NCT04686825|Drug|DA-8010 5mg (Fasting)|Test drug llI : DA-8010 5mg (Fasting)
15771073|NCT04686786|Drug|CVL-865|Participants will receive 25 mg CVL-865 tablets orally BID during the treatment period. The dose may be decreased to 17.5 mg BID for tolerability.
15771074|NCT04686773|Biological|AZD1222|"Active substance: ChAdOx1 nCoV-19, a replicant-deficient simian adenoviral vector in the amount of 5 х 10^10 particles per dose.
~Solution for intramuscular injection, supplied in vials in a carton box"
15771075|NCT04686773|Biological|rAd26-S|"Component I (Dose 1) - (0.5 ml per dose) contains:
~Active substance: recombinant adenovirus serotype 26 particles containing the SARS-CoV-2 protein S gene, in the amount of (1.0±0.5) х 10^11 particles per dose.
~Solution for intramuscular injection, supplied in vials in a carton box"
15771076|NCT04686760|Drug|Nitroglycerin|2 mg/ml solution of nitroglycerin used for nebulization four hourly
15771077|NCT04686734|Other|No active intervention (observational only)|No active intervention (observational only)
15771078|NCT04686721|Diagnostic Test|Chest CT scan + baseline spirometry|Patients will perform an initial evaluation at 2 months from hospital discharge using a chest CT scan without contrast-enhancing along with a pulmonary function test using spirometry. Based on results and according to current guidelines, further follow-up or intervention will be administered.
15771079|NCT04686708|Other|Emergency general surgical admissions|All emergency general surgical admissions are admitted initially to the emergency department and then referred to the general surgery department for further management (medical, interventional, or surgical approaches).
15771080|NCT04686695|Device|taVNS|taVNS was applied using a Huatuo stimulator (SDZ-IIB) developed by Suzhou manufacture of Medical Device and Material. Stimulation parameters was 1 mA of electrical current at a frequency of 20 Hz with pulse duration ≤ 1 ms, for 30min,administered twice daily.
15771081|NCT04686682|Drug|JAB-8263|Variable dose, orally Q2D with 28 days each cycle
15771082|NCT04686682|Drug|JAB-8263|RP2D dose, orally Q2D with 28 days each cycle
15771083|NCT04686669|Drug|FOR-6219 capsule formulation|FOR-6219 capsule formulation will be available as a soft gelatine capsule with a single dose of 50 milligrams, administered orally.
15771084|NCT04686669|Drug|FOR-6219 tablet formulation|FOR-6219 tablet formulation will be available as a tablet with a single dose of 50 milligrams, administered orally.
15771085|NCT04686656|Other|nasal oxygen|Nasal cannula will be placed by the anesthesiologist. 6 l/ min of supplemental oxygen will be administered with nasal cannula.
15771086|NCT04686656|Other|buccal oxygen|Ring-adair-elwyn (RAE) tube will be placed by the anesthesiologist. 6 l/ min of supplemental oxygen will be administered with RAE tube.
15771087|NCT04686643|Drug|AGSAVI|S-amlodipine, Valsartan, Indapamide
15771088|NCT04686643|Drug|AGLS|S-amlodipine, Valsartan
15771089|NCT04686630|Other|Video based observational gait analysis and SCALE Test|Twenty-four spastic diparesis and eighteen spastic hemiparesis cases were included in the study. Data was collected from 84 lower extremities. There were 22 female and 20 male patients aged between 4-18 years. Personal and disease-related information of 42 individuals with diplegic or hemiparetic CP were recorded by using the data collection form. Information collection form; The patient's name-surname, age, gender, height, weight, history, gestational age, birth weight, SCALE Test, GMFCS, Modified Ashworth Scale (MAS), Range of Motion (ROM), EVGS, affected side and previous surgical histories were recorded and their functional levels were determined and recorded.
15771090|NCT04686617|Diagnostic Test|Mechanical Vibration|Oral B HummingBird device (Procter&Gamble, USA) with a modified tip was used for the application of vibration. The tip was positioned mid-buccally of teeth to perform buccally directed vibration. HummingBird is prescribed maximum period 0.00885s corresponding to 6800RPM or 113Hz of the motor. The vibration procedure was applied for 10mins/day during the period of 12 weeks.
15771091|NCT04686604|Other|Best practice alert for the notification of patient HFrEF and recommended evidence-based medical therapies (NO drugs are being administered in this trial)|Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction, most recent blood pressure and heart rate, most recent potassium and estimated glomerular filtration rate, and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.
15771092|NCT04686591|Drug|AZD9977 capsule 50 mg|100 mg dose of AZD9977 capsule 50 mg (as 2 x 50 mg capusles)
15771093|NCT04686591|Drug|[14C]AZD9977 Solution for Infusion, 20 µg/mL (NMT 37.0 kBq/5 mL)|One 100 µg dose of [14C]AZD9977 Solution for Infusion, 20 µg/mL (NMT 37.0 kBq/5 mL)
15771094|NCT04686591|Drug|[14C]AZD9977 Oral Suspension, 100 mg (NMT 9.9 MBq)|One 100 mg dose of [14C]AZD9977 Oral Suspension, 100 mg (NMT 9.9 MBq)
15771095|NCT04686552|Dietary Supplement|cinnamon|6 g of ground cinnamon
15771096|NCT04686539|Drug|CBD|CBD oil not containing THC, to be administered sub-lingual.
15771097|NCT04686539|Drug|Placebo|Placebo Oil
15771098|NCT04686513|Other|Observation|observational study
15771099|NCT04686500|Device|Tidal volume measured by spirometer and DIBH surface from CT image|The SOC DIBH CT scan will be transferred to Eclipse treatment planning system for treatment planning. Tidal volume measured by spirometer and DIBH surface from CT image will be used as a reference surface for patient treatment initial setup. CBCT will be acquired before each fractional treatment for the patient alignment before beam delivery.
15771101|NCT04686474|Drug|Azadirachta indica leaves extract containing ointment intervention.|Azadirachta indica leaves extract containing ointment, white petroleum, bee wax, stearyl alcohol
15771102|NCT04686461|Drug|Nigella sativa seeds extract containing ointment intervention|Nigella sativa seeds extract containing ointment Nigella sativa seed extract, bee wax, white petrolatum, stearyl alcohol
15771103|NCT04686448|Drug|propofol-ketamine|patients will receive IV ketofol (0.5 mg/kg ketamine and 1 mg/kg propofol) as bolus injection over 5 minutes in the same syringe then infusion of 0.05 mg/kg/min propofol increased or decreased rate of infusion according to achieve sedation response by modified Ramasy sedation score of ≤ 4
15771191|NCT04685629|Other|25 post non-ICU patients|patients who were not hospitalized in an intensive care unit
15771199|NCT04685603|Biological|AV-COVID-19|Autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein
15771104|NCT04686448|Drug|propofol-fentanyl|patients will receive IV fenofol (1 µg/kg fentanyl and 1 mg/kg propofol) as bolus injection over 5 minutes in the same syringe then infusion of 0.05 mg/kg/min propofol increased or decreased rate of infusion according to achieve sedation response by modified Ramasy sedation score of ≤ 4
15771105|NCT04686435|Other|Non-surgical treatment such as physiotherapy, exercise, corticosteroid injection, medication, acupuncture|Treatment consisting of different non-surgical interventions as recommended by the orthopedic specialist and decided upon in shared decision making with the patient
15771106|NCT04686435|Procedure|Surgery|Surgery can consist of rotator cuff repair, Bankart repair, subacromial decompression, biceps tenodesis or tenotomy, acromioclavicular joint resection.
15771107|NCT04686422|Device|Tetric PowerFill|Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the PowerCure system.
15771108|NCT04686409|Biological|COVID-19 vaccines|Participants will be vaccinated with one of the approved COVID-19 vaccines
15771109|NCT04686396|Device|Demineralized bone matrix|Demineralized bone matrix
15771110|NCT04686383|Drug|CAL056 mesylate|Dosage form: 20 mg CAL056 mesylate/tablet
15771111|NCT04686370|Other|laser treated implant surface|Better marginal bone stability is expected for this type
15771112|NCT04686357|Diagnostic Test|EMMA/ALICE|"Before randomization, an endometrial biopsy (EB) sample will be collected from all participants between day 15 and 25 of a natural cycle or after around 120 hours of progesterone (P) impregnation during a standard HRT cycle. The results of the EMMA/ALICE test will be provided to participants and their gynecologists. Depending on the test results, there are 3 different possibilities:
~Normal result
~Ultralow or Dysbiotic result
~Abnormal result (pathogens) All probiotics and antibiotics that will be used in the study are already authorized by the local health authorities and will be prescribed under their technical data sheet/brochure conditions following the medical indications."
15771113|NCT04686357|Diagnostic Test|EMMA/ALICE|Before randomization, an endometrial biopsy (EB) sample will be collected from all participants between day 15 and 25 of a natural cycle or after around 120 hours of progesterone (P) impregnation during a standard HRT cycle. The results of the diagnosis will not be disclosed with the patients randomized into this arm nor with their gynecologists.
15771114|NCT04686344|Drug|intermittent boluses of Hypertonic saline|intermittent boluses every 6 hours over 30 min for 48 hours
15771115|NCT04686344|Drug|continuous infusion of Hypertonic saline|continuous infusion over a period of 48 hours
15771116|NCT04686331|Diagnostic Test|Biomarkers for pneumonia|"Blood samples will be collected by a medical laboratory technologist and transferred to the local laboratory for analysis of surfactant protein D, Krebs von den Lungen (KL-6), and YKL-40. Laboratory staff will be blinded to participant diagnosis and outcome. None of the biomarkers will be available to the treating physician.
~Diagnostic test of surfactant protein D - will be quantified using enzyme-linked immunosorbent assay (ELISA)-based analysis
~Diagnostic test of KL-6: will be quantified using enzyme-linked immunosorbent assay (ELISA)-based analysis
~Diagnostic test of YKL-40 - will be quantified using enzyme-linked immunosorbent assay (ELISA)-based analysis"
15771117|NCT04686318|Diagnostic Test|Biomarkers for acute pyelonephritis|"Blood samples will be collected by a medical laboratory technologist and transferred to the local laboratory for analysis of CRP, PCT and suPAR. Laboratory staff will be blinded to participant diagnosis and outcome. CRP and PCT results will be available to the treating physician, but the suPAR result will not be available.
~Diagnostic test of CRP. CRP will be measured using an immunoturbidimetric assay (Tina-quant®, Roche) on Roche/Hitachi Cobas© systems.
~Diagnostic test of PCT: Plasma PCT will be quantified by an automated sandwich immunoassay ECLIA (Elecsys®, BRAHMS PCT-analyses) on Cobas© within two hours from collection according to standard procedure.
~Diagnostic test of suPAR: Plasma suPAR will be quantified by using the commercial available suPARnostic© Tubilatex assay reagents (ViroGates, Denmark) on Cobas© as previously validated (35). Separated plasma is kept refrigerated and analysed for suPAR within 48 hours after collection."
15771118|NCT04686305|Drug|Trastuzumab deruxtecan|T-DXd: administered as an IV infusion
15771119|NCT04686305|Biological|Durvalumab|Durvalumab: administered as an IV infusion
15771120|NCT04686305|Drug|Cisplatin|Cisplatin: administered as an IV infusion
15771121|NCT04686305|Drug|Carboplatin|Carboplatin: administered as an IV infusion
15771122|NCT04686305|Drug|Pemetrexed|Pemetrexed: administered as an IV infusion
15771123|NCT04686292|Diagnostic Test|urine flow cytometry|Diagnostic test of urine flow cytometry. A urine sample will be collected according to routine procedure by a study assistant. The sample will be divided into two aliquots; half for routine urine culturing, and half for Point-of-care Urine Flow cytometry (POC-UFC) analysis (UF-5000, Sysmex, Kobe, Japan). The analysis will be performed according to manufacturer's instruction and conducted by laboratory staff. Laboratory staff will be blinded to the participants diagnosis and outcome. The results of the POC-UFC analysis will not be visible to the treating physician.
15771124|NCT04686279|Drug|Tenofovir Douche|660 mg TFV in 125 mL hypo-osmolar solution
15771125|NCT04686266|Behavioral|Health Information + Health Coaching|Virtual Health Coaching for You: The focus of these sessions is helping caregivers take care of themselves. These are virtual health coaching sessions by trained Health Coaches over 6 months with content based on the theoretical framework from our prior research
15771126|NCT04686253|Other|not appliable|not appliable
15771127|NCT04686227|Diagnostic Test|3D Ultrasound|Newly married women between the ages of 18-40 will be evaluated by 3D ultrasonography about the uterine morphology
15771128|NCT04686214|Procedure|heating|patients were aggressively warmed using multiple heating methods such as pressurized air heater and intravenous fluid heater
15771129|NCT04686201|Device|Diabetes Mobile Application|incorporating mobile application usage in managing diabetes mellitus patient in health clinics
15771130|NCT04686175|Drug|INZ-701|Recombinant fusion protein that contains the extracellular domains of human ENPP1 coupled with an Fc fragment from an immunoglobulin gamma-1 (IgG1) antibody (rhENPP1-Fc)
15771192|NCT04685616|Radiation|Involved site radiotherapy|"Involved site radiotherapy as per International Lymphoma Radiation Oncology Group (ILROG) guidelines.
~Recommended dose 30Gy"
15771193|NCT04685616|Drug|Doxorubicin|See arm description
15771194|NCT04685616|Drug|Bleomycin|See arm description
15771195|NCT04685616|Drug|Brentuximab vedotin|See arm description
15771196|NCT04685616|Drug|Vinblastine|See arm description
15771197|NCT04685616|Drug|Dacarbazine|See arm description
15771131|NCT04686162|Other|bae application|"Patients will be assisted by a research team member to install and configure the application bae on their smartphone; then, they will be trained to use it.
~Bae proposes 4 types of assessments :
~5 times a day during 3 days, every month (5 minutes) : patients can assess their emotions, their thoughts, their behavior and their occurrence context.
~Weekly (7 minutes) : consists of a summary of the week, about their emotions, thoughts, behavior, their relationships (family, work, friends), and their quality of life.
~Monthly (5 minutes): assessment of the usefulness and satisfaction about the application.
~Assessment available at any time An action plan is designed to support the participants, to help them facing difficult emotions and feelings, and to encourage them to ask for help.
~They can contact a relative or call the psychiatric emergency service directly by clicking on a button.
~Patients can try to identify their own warning signs, to prevent suicidal behavior."
15771133|NCT04686123|Other|Active Stretching or Self-stretching exercises|Pectoralis minor muscle was actively stretched under the supervision of a physiotherapist as follows: - 2 sets of 3-stretches/session/day, for 5 consecutive days a week, for 3 weeks
15771134|NCT04686123|Other|Active strengthening Or Self-Strengthening exercises|Lower trapezius muscle was strengthened under the supervision of a physiotherapist as follows: -2 sets of 5-rep./session/day, for 5 consecutive days in 1st week, progressed to 10 and 20 reps./session/day for 2 weeks and 3 weeks respectively.
15771135|NCT04686110|Other|angiographic optical coherence tomography|angiographic optical coherence tomography
15771136|NCT04686097|Procedure|treatment: puncture of coagulation|ultrasound-guided puncture of coagulation
15771137|NCT04686097|Procedure|treatment: sclerosing agent injected|ultrasound-guided sclerosing agent injected
15771138|NCT04686084|Device|Dual-energy computed tomography scan|Diagnostic CT scan
15771139|NCT04686071|Other|PNF method|Treatment in the study group was conducted with PNF method with a use of indirect training based on irradiation phenomenon. The program included: proprioceptive stimulation of the operated limb, improving trunk stabilization and active control, active foot training, muscle strength facilitation of lower limbs in closed kinematic chain with considering periarticular stabilization within the operated knee joint as well as exercises improving mobility of the operated knee, verticalization and locomotion with emphasis on the stance phase.
15771140|NCT04686071|Other|Standard rehabilitation|In the control group standard rehabilitation protocol was used in patients following TKA, which is mainly based on activities in open chains (passive exercises with continuous passive motion (CMP) device, active exercises, isometric, active resistance, patella mobilization, deep tissue massage, verticalization and gait relearning).
15771141|NCT04686058|Drug|Propofol 10 MG/ML Injection|
15771142|NCT04686058|Drug|Midazolam injection|
15771143|NCT04686058|Drug|Pethidine Hydrochloride 50 Mg/mL Solution for Injection|
15771144|NCT04686058|Device|target controlled infusion pump|
15771145|NCT04686058|Device|patient-controlled sedation pump|
15771146|NCT04686045|Other|observational study|observational study
15771147|NCT04686032|Other|Advanced early Rehabilitation Program|Patient education, Ambulation, In bed exercises, Deep breathing exercises: (5 rep x 3set), Connective tissue manipulation for intestinal motility (5 min) and TENS* for incisional pain (30min)
15771148|NCT04686032|Other|Early ambulation|Patient education & Assisted ambulation out of bed including walking away from bedside for at least 15 min gradually moving to Unsupervised ambulation for 30 min
15771149|NCT04686019|Other|Inspiratory muscle training (IMT)|"IMT and conventional neurorehabilitation - treatment as usual. The intervention group will add-on IMT sessions exercising at 30 % of MIP. MIP is measured by instructing the patient to perform five forceful inspirations against an occluded mouthpiece (Power Breath). The best score is multiplied by 0.3 to determine the resistance. IMT is performed with IMT Threshold flute with the calculated resistance. During the measurement with Power Breath the patient sits straight up and uses nose clip. The patient can receive help to hold the Power Breath if necessary.
~One session of IMT with IMT threshold flute consists of 2 times 15 inspirations in normal breathing rhythm (5-10 min). Patients in the intervention group perform 2 sessions a day (morning and evening), training is performed prior to a meal, 7 days a week for 3 weeks."
15771150|NCT04686006|Drug|Potassium Iodide|
15771151|NCT04685993|Drug|LPCN 1144|Oral LPCN 1144, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose).
15771152|NCT04685980|Procedure|spinal anaesthesia with local anaesthetic and intrathecal morphine|Patients undergoing cesarean delivery and received spinal anaesthesia with local anaesthetic and intrathecal morphine
15771153|NCT04685967|Device|Glass ionomer|Equia Forte HT, GC, Tokyo, Japan
15771154|NCT04685967|Device|Bulk-fill composite|SonicFill2, Orange, CA, USA
15771155|NCT04685954|Device|Filtek Bulk-Fill Posterior|Bulk-fill restorative composite
15771156|NCT04685954|Device|Filtek Ultimate Universal|Incremental restorative composite
15771159|NCT04685928|Diagnostic Test|MRI and MRI-guided prostate biopsy|Multiparametric MRI prostates in the MRI arm will be performed using 1.5 or 3.0 Tesla scanner with a pelvic phased array coil and contrast injection. T2-weighted, diffusion weighted and dynamic contrast enhanced scans will be included and the reporting of MRI finding will be done according to PI-RADS (Prostate Imaging-Reporting and Data Systems) v2.1 recommendations. MRI-guided targeted biopsy will be performed by Urologists experienced in MRI-guided biopsy for men with PI-RADS score 3-5.
15771160|NCT04685928|Diagnostic Test|TP-arm Systematic biopsy|Transperineal 24-core biopsy using a free-hand technique under local anaesthesia will be performed under transrectal ultrasound guidance for men in this arm
15771161|NCT04685915|Drug|Ibrutinib|Capsule, taken by mouth once daily
15771162|NCT04685915|Drug|Copanlisib|Intravenous Infusion
15771163|NCT04685902|Device|One-way speaking valve|One-way speaking valve is a small device that attaches to the tracheostomy tube, to allows tracheostomy patient to breathe in through his or her trach tube. After the inhalation, the speaking valve closes. Air is breathed out (exhaled) up through the vocal cords, then through the mouth and nose.
15771164|NCT04685889|Procedure|Resin infiltration|"A sufficient amount of HCl was applied to the lesion using the icon etch syringe included in the set and was allowed to sit for 2 minutes. After washing with water for 30 seconds, the tooth was dried using an air spray. Once the enamel surface appeared chalky, Icon® dry application was initiated.
~Ethanol was applied to the lesion using the Icon® dry syringe included in the set, and after 30 seconds it was dried using an air spray. Sufficient amount of resin infiltrant was applied to the lesion using the Icon® infiltrant syringe. The resin infiltrant was applied to the lesion surface by massaging with the tip of the syringe in circular movements for 3 minutes such that it penetrates the surface thoroughly. The resin infiltrant was polymerized for 40 seconds with a light device."
15771165|NCT04685876|Drug|Liposomal bupivacaine|4-quadrant TAP block with liposomal bupivacaine
15771166|NCT04685876|Drug|Plain bupivacaine|4-quadrant TAP block with plain bupivacaine
15771167|NCT04685876|Drug|Normal saline|placebo (normal saline).
15771168|NCT04685863|Other|Mobilizing the knee with active neurodynamic sliding technique (active Slump slider)|60 physiotherapy students perform measurements during three tutorials. The first involves training in evaluation techniques. The second involves mobilizing the knee, out of the SLUMP position. The third tutorial includes neuronal mobilization in SLUMP.
15771169|NCT04685850|Other|sequela evaluation|clinical and neurological examination, psychological evaluation (cognitive performance), an auditory, speech and visual assessment and an evaluation of the child's school performance
15771170|NCT04685837|Other|therapeutic exercise|"As soon as the study investigators have obtained a significant sample of patients with non-specific sub-acute low back pain, the intervention will begin.
~The principal investigator will perform an individual assessment of the patients. At the end of the assessment, he will randomly distribute them into two groups. Tele-rehabilitation group and face-to-face group.
~On the one hand, the main researcher will explain the application works to the tele-rehabilitation group. For 8 weeks, they have to perform 2 therapy exercise training sessions following the instructions on the application.
~On the other hand, the researcher will explain the protocol to be followed by the group face to face. In addition, he will provide a schedule to follow a correct development of the protocol. Like the tele-rehabilitation group, they will carry out 16 sessions over 8 weeks.
~At the end of the protocol, the principal investigator will perform an individualized assessment of each of the study participants."
15771171|NCT04685824|Device|Biofeedback Training|Audiovisual stimulation
15771172|NCT04685824|Device|Immersive Virtual-Reality|Audiovisual stimulation
15771173|NCT04685811|Drug|68Ga-PSMA-cyclotron Versus 68Ga-PSMA-generator|68Ga-PSMA-cyclotron and 68Ga-PSMA-generator; single dose each, approximately 100-300 mBq.
15771174|NCT04685798|Device|Diffusion-weighted imaging magnetic resonance imaging|The research MRI study of the head and neck will be performed on a Siemens 3T MRI Scanner system
15771175|NCT04685772|Drug|Methylprednisolone|"The Methylprednisolone dose pack (Medrol Dose Pack) is pre-packaged with dosing instructions. This dose pack is tapered over 7 days and administration will be the following for all patients:
~Day 1 (total 24 milligrams (mg)) - 8mg before breakfast, 4mg after lunch and dinner, and 8mg at bedtime Day 2 (total 20mg) - 4mg before breakfast, after lunch and dinner, and 8mg at bedtime Day 3 (total 16mg) - 4mg before breakfast, lunch, dinner, and at bedtime Day 4 (total 12mg) - 4mg before breakfast, after lunch, and at bedtime Day 5 (total 8mg) - 4mg before breakfast and at bedtime Day 6 (total 4mg) - 4mg before breakfast Day 7 (total 0mg) - Completed"
15771178|NCT04685746|Behavioral|Balanced Growth Protocol|Assessment of the Balanced Growth Protocol, consisting of audiovestibular testing, motor and cognitive tasks
15771179|NCT04685733|Device|Non-invasive hemodynamic measurements|Non-invasive hemodynamic measurements
15771180|NCT04685720|Device|LungFit|LungFit for NTM is an experimental device that produces Nitric Oxide from the ambient air.
15771181|NCT04685707|Device|Visual feedback monitoring system|Participants will follow the exercise monitoring system's instructions displayed on a TV. Treadmill walking speed will be set at a comfortable walking speed.
15771182|NCT04685707|Device|Control|Participants will monitor the intensity of exercise independently using a standard heart rate monitor and control it by adjusting the treadmill speed (walking speed).
15771183|NCT04685694|Drug|Misoprostol|sl 800 mcg misoprostol
15771184|NCT04685681|Behavioral|Hiking challenge|The main intervention of interest is the provision of free access to a local hiking challenge (which is provided following baseline assessments in the experimental group and after the conclusion of the study in the control group; $20 value). If participants choose to sign up for the free hiking challenge, they receive a list of local hikes/nature walks, accompanying maps, scavenger-hunt-like activities (finding a certain landmark on each hike), and the opportunity to earn prizes and engage with other hikers on social media.
15771185|NCT04685681|Other|Activity list|The control group will receive a list of CDC-recommended activities following the baseline survey and will receive the hiking challenge as a delayed intervention following post-test.
15771187|NCT04685655|Other|Therapeutic plasma exchange|Treatment with therapeutic plasma exchange. Plasma from healthy donors is used.
15771188|NCT04685642|Drug|Aspirin|Aspirin (100mg/day)
15771189|NCT04685642|Drug|Atorvastatin|Atorvastatin (20mg/day)
15771190|NCT04685629|Diagnostic Test|25 post ICU-patients|patients who were hospitalized in an intensive care unit
15771200|NCT04685590|Drug|Dasatinib + Quercetin|D+Q will be administered once daily (1st dose of each cycle will be given, supervised, at the clinic visit; the 2nd dose will be taken at home) for 2 consecutive days followed by a 13-day (+/- 2 day) no-drug period for 12 consecutive weeks for 6 rounds of administration.
15771201|NCT04685590|Other|Placebo Capsules|Matching placebo capsules following the same administration protocol as the experimental treatment - administered once daily (1st dose of each cycle will be given, supervised, at the clinic visit; the 2nd dose will be taken at home) for 2 consecutive days followed by a 13-day (+/- 2 day) no-drug period for 12 consecutive weeks for 6 rounds of administration.
15771202|NCT04685577|Drug|Nefopam|Nefopam HCl inhibits the proliferation and viability of human mesenchymal fibroblasts with elevated β-catenin expression without affecting normal fibroblasts. Nefopam HCl primarily targets cells in which β-catenin is above normal physiologic levels. This threshold effect makes Nefopam HCl a good prospective therapeutic agent by limiting its effect to abnormal mesenchymal cells.Nefopam HCl has been found safe and effective for the reduction of dermal scarring following standardized human dermal wounds of critical depth that produces HTS in normal human volunteers Phase 1 study. In the current study, it is proposed that the concentration of the cream will be 3% and the timing of application will be delayed until after re-epithelialization at about 21 days to maximize the antiproliferative effects of NEFOPAM during the fibrotic/proliferative phase of healing.
15771203|NCT04685577|Other|Placebo (Vehicle)|Participants will receive vehicle with out the investigational product
15771204|NCT04685564|Drug|RBD1016|"Sentinel cohort design is used in each cohort: each cohort will be administered in two batches, the first 2 subjects will receive RBD1016 or placebo respectively, and safety assessment will be done on D8±1. After safety is confirmed through SRC assessment, the remaining 6 subjects will be randomly assigned to receive RBD1016 or placebo in a ratio of 5:1. SRC will assess the safety after all the subjects in each cohort complete the 28-day safety observation and the subjects may proceed to the next dose cohort with permission.
~Only after all the subjects in the previous dose cohort have completed the safety assessment by SRC (observed for 28 days) may the next dose cohort be initiated with permission."
15771205|NCT04685564|Drug|Placebo|the same as RBD1016
15771206|NCT04685551|Behavioral|Change in knowledge, motivation, skills, and resources|Provide/enhance knowledge, modify attitudes, motivate and provide skills and resources to improve survivorship outcomes.
15771207|NCT04685538|Drug|Chloroprocaine 3%|"Administration: three IMP drops instillation as follow:
~1st Drop instillation, then wait for 5 minutes
~Eye Disinfection, then wait for 2 minutes
~2nd Drop instillation, then wait for 1 minute
~3rdDrop instillation, then wait for 1 minute
~Start of Surgery."
15771208|NCT04685538|Drug|Tetracaine 0.5%|"Administration: three IMP drops instillation as follow:
~1st Drop instillation, then wait for 5 minutes
~Eye Disinfection, then wait for 2 minutes
~2nd Drop instillation, then wait for 1 minute
~3rdDrop instillation, then wait for 1 minute
~Start of Surgery."
15771209|NCT04685525|Behavioral|Mycobiome Supporting Diet|MSD takes combines elements from several diets (e.g., Paleo, low-carbohydrate, vegetarian, and Mediterranean) and excludes elements of these diets that have been specifically proven to increase pathogenic fungi in the human gut.
15771210|NCT04685512|Drug|tenofovir disoproxil and emtricitabine|Experimental drugs administration of 7-day short course TDF/FTC
15771211|NCT04685499|Drug|OBP-301|Telomerase-specific Type 5 Adenovirus. OBP-301 OBP 301 will be injected intratumorally into tumor lesions.
15771212|NCT04685499|Drug|Pembrolizumab|Standard dose pembrolizumab 200 mg IV every 3 weeks for up to one year
15771213|NCT04685486|Other|Virtual Reality|Immersive and interactive game played through a portable head-mounted display as a distraction mechanism
15771214|NCT04685473|Drug|T-1101 (Tosylate)|T-1101 (Tosylate) Capsule
15771215|NCT04685460|Other|customized 3D-printed bolus fabricated based on reconstruction of computed tomography (CT) images|customized 3D-printed bolus fabricated based on reconstruction of computed tomography (CT) images were used in this study.
15771216|NCT04685447|Procedure|Expanded Hemodialysis for Covid19 maintenance hemodialysis patients|After Covid19 diagnosis participants are randomized to receive Expanded Hemodialysis for two weeks
15771217|NCT04685447|Procedure|Hemodialysis by protein-leaking dialyzer for Covid19 maintenance hemodialysis patients|After Covid19 diagnosis participants are randomized to receive hemodialysis by protein-leaking dialyzer for two weeks
15771218|NCT04685434|Other|Shriners Hospital for Children Upper Extremity Evaluation|The interventions are evaluating tools for the functional performance of the upper extremity.
15771219|NCT04685421|Drug|Bupivacaine liposome|Liposomal Bupivacaine PKs collections up to 96 hours on children from 2 to 17 years in pediatric cardiac surgeries.
15771220|NCT04685408|Behavioral|TEAM|TEAM is informed by principles of social cognitive theory TEAM uses nurses and peer educator dyads (PEDs) composed of patients and their care partners to co-deliver an intervention intended to help reduce future stroke risk. Team begins with one 60-minute 1:1 orientation session, in which the nurse and PED meet with the patient and his/her care partner. This is followed by 6 hour-long group sessions with 6-8 patients and their care partners held approximately weekly. The first orientation session will be done approximately 1 week post baseline, followed by group sessions were done at 2, 4, 6, 8, 10 and 12 weeks post-baseline.
15771221|NCT04685408|Behavioral|ETAU|ETAU will consist of an orientation visit with a nurse who will provide patient-education materials on stroke risk adapted from the American Heart Association materials and cover common risk factors such as hypertension, obesity, high salt/high fat diet and diabetes. Patients will also receive basic written information in their language of preference and tailored to the reading level of most patients at the clinic. Patients will be offered the opportunity to bring a family member with them to this visit who may also ask questions and who can assist them with understanding written materials for those with limited literacy. The nurse in ETAU will then follow-up with participants with a series of 9 brief phone calls spaced out over the course of 6 months (approximately every 2 weeks during months 1 and 2, then approximately monthly thereafter). Content will reinforce materials provided in the orientation visit and the nurse will be available to answer questions that may arise.
15771222|NCT04685395|Drug|Ribamipide gargle \benzdymine HCL gargel|ribamipide gargle 6 time daily 5ml dosage
15771223|NCT04685369|Other|Medical Data extraction|Medical Data extraction
15771253|NCT04685148|Drug|Transdermal patch placebo|Placebo patches will be administered at day 0 (+1) to day 21 postpartum.
15771224|NCT04685356|Other|IBAIP : Infant Behaviour Assessment and Intervention Program|The IBAIP intervention program consists of providing an intervention with the child and their family, at home, upon discharge from hospital and up to a corrected age of 6 months. Interventions therefore take place at the early stage of the child's brain development. The intervention is performed by a IBAIP-trained and certified physiotherapist or psychomotor therapist trained , at the rate of one session per month over a period of approximately 6 to 8 months (6 months of corrected age). The session takes place in the child's usual living environment, at home, in the presence of at least one of the parents. It focuses on the child's behaviors and consists of assisting the family in its interactions with the child so that these are adapted and responsive to the child's development needs over time through repeated interventions.
15771225|NCT04685356|Other|Standard Support|One medical consultation per month and, if indicated by the physician providing follow-up, medical specialist and / or paramedical (physiotherapy, speech therapy, psychomotricity, etc.) consultations including interventions in the case of developmental delays
15771226|NCT04685356|Other|Ages and Stages Questionnaire (ASQ)|Global development screening tool
15771227|NCT04685356|Other|Parenting Stress Index (PSI)|Index used to detect difficulties sufficiently significant that they might require psychosocial intervention
15771228|NCT04685356|Other|Bayley Scales of Infant and Toddler Development (BSID-III)|This test was designed to measure the development of infants / young children. This assessment examines all spheres of child development, identifies children with developmental delay and assesses children's developmental performance compared to their peers.
15771229|NCT04685343|Behavioral|Quantitative Sensory Testing|Quantitative sensory testing (QST) consisting of 4 pain induction and sensory sensitivity tasks (i.e., pressure applied to the thumbnail, arms, shoulders, and lower abdomen, a cold water task, and one video-watching task).
15771230|NCT04685343|Other|fMRI|Functional magnetic resonance imaging (fMRI) session consisting of structural and functional brain scans.
15771231|NCT04685330|Procedure|Ultrasound guided procedure|Single-arm, open-label device efficacy study to enroll 200 patients who have been ordered to have an ultrasound-guided procedure by the MGH Interventional Radiology department, including paracentesis, thoracentesis, biopsy, or ultrasound-guided drain placement. Patients will be restricted to adults who can consent.
15771232|NCT04685330|Device|Portable ultrasound|The FDA approved Healcerion SONON portable ultrasound (linear and curved) will be used during clinically indicated standard ultrasound-guided procedures following clinical standard of care. A standard clinical ultrasound will subsequently be used for image guidance as the gold standard. Images will be compared and improved. The efficacy of the portable ultrasound will be monitored by the clinical user and any complications within 30 days will be determined by chart review.
15771233|NCT04685317|Device|Sentinel® Cerebral Protection System|A percutaneously delivered dual-filter protection device, designed to capture and remove debris dislodged during transcatheter aortic valve replacement procedures.
15771234|NCT04685304|Genetic|Pharmacogenetic Testing|Genetic results will be reported for CYP2D6, CYP2C19, CYP2C9, CYP2B6, CYP3A4, CYP3A5, SLCO1B1, TPMT, and VKORC1.
15771235|NCT04685304|Other|Pharmacist Consultation Note|Recommendations will be based on phenotypes translated from genetic data in accordance with CPIC guidelines. Drug interactions will be incorporated into phenotype assignments when appropriate.
15771236|NCT04685304|Other|Delayed pharmacogenetic testing|Pharmacogenetic testing and a pharmacist consultation note will be provided to participants provided to the standard care arm once 3 months have passed since their baseline visit.
15771237|NCT04685291|Procedure|Ultrasound-guided block of the supraclavicular nerves|The supraclavicular nerves (SCN) arise from the 3rd and 4th roots of the spinal nerves. After emerging from the spine, they run at the rear margin of the sternocleidomastoid muscle and divide into their three terminal branches. With a high-resolution Ultrasound (US)-probe they can be visualized as a grape-like structure under the skin. At this location, patient's skin is disinfected and covered with a sterile perforated blanket. The US-probe is covered with a sterile sheath. The patient is positioned as comfortably as possible so that the broken clavicle is not mobilized. SCN are shown by US and a 0.5 mm needle is advanced through the patient's skin in order to direct it to the nerves under US-guidance. Both the nerves and the needle are permanently visualized. As soon as the needle tip is placed next to the SCN, 2-3 millilitres of a long-acting LA are injected. The distribution of the LA around the nerves is controlled.
15771238|NCT04685291|Drug|Conventional pain management|"oral pain medication in patients younger than 70 years: Ibuprofen 400mg (1-1-1) AND Metamizole 500mg (max. 2 tbl. every 6 hours)
~oral pain medication in patients older than or equal 70 years: Acemetacin 60mg (1-1-1) AND Metamizole 500mg (max. 2 tbl. every 6 hours)
~Rescue analgesic medication for all patients: oxycodone hydrochlorid (drops) p.o. (10 mg/ml) 0.1mg/kg p.o. hour
~In the ED Rescue analgesic medication for all patients: Fentanyl 50mcg i.v. (max. 200mcg/hour)"
15771239|NCT04685278|Biological|Blood samples|Blood samples were collected in dry tubes on days 1, 3, 5, 8 and 10 of hospitalization
15771242|NCT04685252|Other|(BL) NCC3001|Probiotic strain (BL) NCC3001 packed in stickpack, to be consumed daily.
15771243|NCT04685252|Other|Placebo|Matching placebo containing maltodextrin packed in stickpack, to be consumed daily.
15771244|NCT04685239|Device|dual mobility cup|The use of a Sunfit dual mobility cup
15771245|NCT04685239|Device|unipolar cup|The use of a TMT cup
15771247|NCT04685213|Device|Electrical Stimulation|Subjects will receive an active electrical stimulation device to wear for 1 hour daily for up to 4 weeks.
15771248|NCT04685213|Device|Electrical Stimulation - Sham|Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.
15771249|NCT04685174|Device|Invos Model 5100C Cerebral/Somatic Oximeter|To measure the correlation between post arterial and venous anastomoses (reperfusion) NIRS values of transplanted kidney and post-transplant graft failure as manifested in initiation of renal replacement therapy post transplant
15771250|NCT04685161|Procedure|Surgical extrusion|Invasive treatment option for fractured tooth
15771251|NCT04685161|Device|Fibre post|Easy approach for treatment
15771252|NCT04685148|Drug|Transdermal patch estradiol|Estradiol patches (200 μg per day by transdermal delivery) will be administered at day 0 (+1) to day 21 postpartum.
15771256|NCT04685122|Procedure|Phacoemulsification and intraocular lens implantation for cataract|Phacoemulsification and intraocular lens implantation for cataract
15771257|NCT04685109|Device|Alocross 0.2% Unit Dose|Eye Drops
15771258|NCT04685109|Device|Vismed|Eye drops
15771259|NCT04685096|Other|Test product creme|twice daily application of creme containing 2% NMN
15771260|NCT04685096|Other|Reference creme|twice daily application of reference creme
15771261|NCT04685070|Drug|HS-10296 (Almonertinib)|Neoadjuvant treatment stage: HS-10296 110mg, qd, po, 4 weeks per cycle, 2-4 cycles in total; Surgical treatment stage: CR + PR patients and SD + PD patients who could still undergo surgery will receive radical surgery; Adjuvant treatment stage: CR, PR and SD patients who have been treated surgically: HS-10296 110mg, qd, po, up to 48 weeks (including neoadjuvant stage). PD patients: transferred into medical oncology or/and radiation oncology and receive comprehensive therapy.
15771262|NCT04685057|Dietary Supplement|Placebo|Intervention with a daily dose of placebo for 6 months
15771263|NCT04685057|Dietary Supplement|Probiotic|Intervention with a daily dose of probiotic for 6 months
15771264|NCT04685057|Dietary Supplement|Follow-up probiotic|Intervention with a daily dose of probiotic for 6 months
15771265|NCT04685044|Device|IH 1Tx32Rx Head Array|BrainPET insert
15771266|NCT04685031|Drug|Nitroglycerin ointment|after venipuncture, 1.5 cm (about 2 g) of ointment was applied in the distal part of the Angio catheter and the site was dressed with sterile gauze. In three time periods of 24, 48 and 72 hours from the time of venipuncture.
15771267|NCT04685031|Drug|Clobetasol Topical|after venipuncture, 1.5 cm (about 2 g) of ointment was applied in the distal part of the Angio catheter and the site was dressed with sterile gauze. In three time periods of 24, 48 and 72 hours from the time of venipuncture.
15771268|NCT04685018|Device|fMRI acquisition|Participants from the two groups will perform an avoidance-relief task inside an MRI scanner
15771269|NCT04685005|Dietary Supplement|"Wake Up"|The current composition of the WakeUp® beverage consists of herbal extracts of guarana, green tea, elderberry and Fruit-up
15771270|NCT04685005|Dietary Supplement|Caffeine|Caffeine
15771271|NCT04684992|Device|GEBT Telehealth Administration Usability|Establish the usability of a telehealth platform for the administration of GEBT
15771272|NCT04684979|Biological|Hematopoietic Stem Cells from HLA-compatible Related|NMA PBSCT (Non-Myeloablative peripheral blood stem cell transplantation) incorporating rituximab and utilizing PBSC (Peripheral blood stem cells) to increase graft cell dose in patients with selected B lymphoid malignancies.
15771273|NCT04684979|Biological|Hematopoietic Stem Cells from HLA Unrelated|NMA PBSCT (Non-Myeloablative peripheral blood stem cell transplantation) incorporating rituximab and utilizing PBSC (Peripheral blood stem cells) to increase graft cell dose in patients with selected B lymphoid malignancies.
15771274|NCT04684966|Device|Neuromuscular Electrical Stimulation|Standart pulmonary rehabilitation with combined quadriceps and triceps surae ESNM using two identical electrotherapy devices allowing simultaneous stimulation of the quadriceps and triceps (EG group).
15771275|NCT04684966|Device|Sham Neuromuscular Electrical Stimulation|Standart pulmonary rehabilitation with combined sham NMES of the quadriceps and triceps surae performed using two identical electrotherapy devices allowing simultaneous stimulation of the quadriceps and triceps (CG group)
15771276|NCT04684953|Procedure|Throid autotransplantation|Operative
15771277|NCT04684953|Drug|Hormone|thyroid hormone replacement therapy
15771278|NCT04684940|Biological|Valoctocogene roxaparvovec|Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Hemophilia A
15771279|NCT04684927|Device|MID-C System -Minimal invasive deformity correction system for the treatment of AIS|"A 5 years follow-up will be performed for all patients who underwent AIS repair surgery using the MID-C System. The follow-up in order to assess safety and efficacy measurments. Eligible Patients will be followed and assessed at the following time points: Immediate Post-op up to 6 weeks, 6 months, 12 months, and then annually out to 5 years post-implantation.
~During the study, the following rating scales and assessments will be conducted to assess the probable benefit and safety of the treatment: Physical exam,X-rays,Cobb angle measurements,Adverse Events (AEs) and Scoliosis research society (SRS-22) questionnaire: The questionnaire is commonly used to assess health related quality of life in children with AIS."
15771280|NCT04684914|Biological|HepTcell|Intramuscular injection
15771281|NCT04684914|Drug|Placebo|Intramuscular injection
15771282|NCT04684901|Other|AlloWrap® Amniotic Membrane|AlloWrap is a human amniotic membrane designed to provide a biologic barrier following surgical repair.
15771283|NCT04684888|Procedure|Visumax Femto-flap|"Under topical anesthesia [Tetracaine eye drop 0.5%]. A-90 µm thick flap was done by using Visumax femtosecond laser. The flap hinge was set to be nasally placed. A nasal-hinge flap with 90 µm thickness, 8.8 mm flap diameter, and 90º side cut angles were created with 500 kHz Visumax FSL, 160 nJ energy [Carl Zeiss, Meditec, Germany]. The sphero- cylindrical refractive corrections with optical zone 6.5 mm and ablation zone 8.0 mm were done by excimer laser operating system [Carl Zeiss, Meditec, MEL 90, Germany]. Automatic iris registration and pupil-tracking system were activated before photoablation. The patient's eyes were examined postoperatively on a slit-lamp biomicroscope and all treatments that were given for home use have been explained in terms of frequency of instillation, possible side effects, and benefits before discharging them on the same day.
~Follow up visits were scheduled clearly on printed patients' discharging cards."
15771284|NCT04684888|Procedure|Sub Bowman's keratomileusis (SBK)-flap|"Under topical anesthesia [Tetracaine eye drop 0.5%] .A-90µm flaps done using Maria one use plus SBK mechanical microkeratome with a nasal located hinge. The sphero- cylindrical refractive corrections with optical zone 6.5 mm and ablation zone 8.0 mm were done by excimer laser operating system [Carl Zeiss, Meditec, MEL 90, Germany]. Automatic iris registration and pupil-tracking system were activated before photoablation. The patient's eyes were examined postoperatively on a slit-lamp biomicroscope and all treatments that were given for home use have been explained in terms of the frequency of instillation, possible side effects, and benefits before discharging them on the same day.
~Follow up visits were scheduled clearly on printed patients' discharging cards
~."
15771285|NCT04684875|Device|Radiofrequency Stylus|Low power radiofrequency energy delivered to the posterior nasal nerve area
15771317|NCT04684550|Drug|Stabilized hypochlorous acid|Application of 2 puffs and gargles every 8 hours of a solution with low concentrations of S-HCLO (3-5 ppm).
15773364|NCT04668066|Drug|Placebo|Placebo given intravenously or subcutaneous
15771286|NCT04684862|Device|Medtronic SynchroMed II programmable pump connected to an Intera tapered catheter (Combined Infusion System)|This infusion system is composed of a Medtronic SynchroMed II programmable pump connected to a Intera tapered catheter. Specifically, the Medtronic pump comes with a small connector that ends in a metal flange. During the operation, under sterile conditions, the distal 1 cm of the flange is severed using a scissor. Then, using a Intera connector pin, the end of the Medtronic catheter is connected to the Intera catheter . Two 2-0 silk ties secure the catheters to the pin. The pump and catheter are then inserted into the patient into the abdominal wall or into the chest wall. The catheter is inserted into an artery within the abdomen (usually the gastroduodenal artery but it depends on the exact arterial branching in the individual patient) that feeds the liver.
15771287|NCT04684836|Other|Exposure to telemedicine, after the onset of the pandemic|Telemedicine exposure will be defined based on the proportion of all visits at a given clinic that are delivered via telemedicine in each month.
15771288|NCT04684823|Device|Patch Cap|A prescription container cap to track the dispensing of an oral dose of medication with an associated app which tracks the adherence to medication regimen.
15771289|NCT04684823|Device|Patch App|A mobile app that is used with Patch Cap to track adherence to medication regimen
15771290|NCT04684810|Behavioral|Community Lay Therapist-Administered EBT|Community Therapists Used CBT and EMDR Interventions
15771291|NCT04684797|Behavioral|Virtual T-maze task|Patients will have to perform the virtual T-maze task, which is known to elicit reward positivity. During this task, the patients will see a virtual T-maze on a computer screen and have to choose at every junction whether they go right or left. Depending on the direction they choose, they either get positive or negative feedback (reward or no reward). This feedback is chosen completely at random, on a 50% reward/50% no reward basis.
15771292|NCT04684784|Device|Intervention-Dry Needling|Deep Dry Needling into the site of the latent TriggerPoint of the upper trapezius muscle. 1 session in upper trapezius muscle moving the needle up and down ten times.
15771293|NCT04684784|Device|Control-Dry Needling|Sham Dry Needling into the site of the latent Trigger Point of the upper trapezius muscle with non-penetrating needles
15771294|NCT04684771|Dietary Supplement|MYOSTIM®|Food supplement n° NCT 2485/8 (Red fruits flavor bar) and NCT 2485/7 (Black chocolate flavor bar) delivered by the Federal Public Service, Health, Food chain safety and environment.
15771295|NCT04684771|Dietary Supplement|PLACEBO|Bars with no active ingredient and the same flavor (chocolate and red fruits).
15771296|NCT04684758|Other|Self-completion of a questionnaire|The questionnaire will be translated into 5 languages (English, Spanish, Portuguese, Arabic, and Russian) in order to allow almost all of the participants to answer the survey themselves, without assistance. In order to not exclude those who cannot read, or those who do not master any of the 6 languages offered, the questionnaire may be administered with the assistance of a member of the research team of the associated center, including through a telephone interpretation service, if necessary.
15771297|NCT04684745|Drug|BION-1301|A solution for IV infusion administered as multiple doses
15771298|NCT04684719|Biological|low titer whole blood|low titer whole blood, group O, Rh positive kept to either 21 days or 35 days based upon which preservation process is employed at each respective participating site
15771299|NCT04684719|Biological|Standard Care|crystalloid infusion or blood component transfusion resuscitation
15771300|NCT04684706|Device|intermittent Theta Burst Stimulation|The present study will utilize TMS dosage of iTBS of 18 000 pulses a day for 5 consecutive days.
15771301|NCT04684693|Device|Laser|Laser puncture and exercise
15771302|NCT04684693|Procedure|Control|Exercise
15771303|NCT04684680|Dietary Supplement|zamzam water|will receive the normal need of daily requirement of water (2.5 liter) in form of zamzam water till patients deliver or till term
15771304|NCT04684680|Dietary Supplement|tap water|will receive the normal need of daily requirement of water (2.5 liter) in form of tap water
15771305|NCT04684667|Drug|Propranolol Therapy for Infantile Hemangioma|If there are no contraindications to propranolol, it will be given at initial dose of 0.5 mg /kg/day in 2-3 divided doses with feeds and the patients will be observed for clinical signs of serious adverse reactions. If the dose is tolerated, it will be maintained for four to seven days, and then it will be increased by 0.5mg/kg/day every four days to the target dose of 2mg/kg/day. The patients will be observed for 2 hours after each dose increase for the clinical signs of severe side effects.
15771306|NCT04684654|Biological|BMS-986325|Specified dose on specified days
15771307|NCT04684654|Other|Placebo for BMS-986325|Specified dose on specified days
15771308|NCT04684641|Drug|Standard Dose YPT-01|Participants will be randomized to receive the standard dose of phage therapy YPT-01.
15771309|NCT04684641|Other|Placebo|Participants will be randomized to receive the placebo.
15771310|NCT04684628|Drug|68Ga-PSMA PET/CT|Administration of 68Ga-PSMA-11 followed by a PET/CT scan at 45 min after injection.
15771311|NCT04684602|Biological|PrimePro™/ PrimeMSK™|Injection via condition specific route of administration.
15771312|NCT04684589|Drug|Tadalafil 20 MG|Tadalafil is an FDA approved, clinically-available drug that inhibits the enzyme phosphodiesterase type 5A (PDE5). Subjects who are randomized to this arm will be provided with 20mg of Tadalafil to take every day for 12 weeks, beginning at their baseline visit.
15771313|NCT04684589|Drug|Placebo|Subjects in this arm will be provided with 20mg Placebo to take every day for 12 weeks, beginning at their baseline visit.
15771314|NCT04684576|Device|Permobil Explorer Mini|The use of powered mobility devices for young children with cerebral palsy is increasingly recommended. The Permobil Explorer Mini is a new pediatric powered wheelchair that has been cleared by the FDA. The Explorer Mini will be provided for 8-weeks, and families will be provided with suggested use frequencies and provided with support for implementing the device intervention with their child.
15771315|NCT04684576|Device|Modified Ride-On Car|Access to commercial powered mobility devices is often limited by funding or size. Many families use toy ride-on cars for early mobility, which can be easily adapted for safety and accessibility. The modified ride-on car will be provided for 8-weeks, and families will be provided with suggested use frequencies and provided with support for implementing the device intervention with their child.
15837215|NCT04147234|Drug|BI 1387446|intratumoral injection
15771318|NCT04684550|Drug|Placebo|Application of 2 puffs and gargles every 8 hours of a solution with low concentrations of S-HCLO (3-5 ppm).
15771319|NCT04684537|Procedure|Extracorporeal shockwave therapy (ESWT)|The therapy will be performed with the focused piezoelectric shockwave (F10G4 Richard Wolf GmbH, Germany). The patient will be kept in the hip flexion, adduction and internal rotation position. After sonography-guided localization of the affected muscle and identification of the trigger point by the participant, ultrasound gel is applied to the skin and the applicator couple is placed with an impulse energy flux density of 0.456-0.882 mJ/mm2 for 3500 impulses.
15771320|NCT04684537|Procedure|Ultrasound-guided piriformis steroid injection|all the participants will receive ultrasound-guided piriformis injection with 10 mg triamcinolone and 1 c.c. 1% lidocaine for one time.
15771321|NCT04684524|Drug|Dupilumab SAR231893|Pharmaceutical form:Injection solution Route of administration: Subcutaneous
15771322|NCT04684524|Drug|Placebo|Pharmaceutical form:Injection solution Route of administration: Subcutaneous
15771323|NCT04684511|Drug|TRM-201 (Rofecoxib)|Eligible patients will be randomized to receive TRM-201 or placebo
15771324|NCT04684511|Drug|Placebo|Matching Placebo
15771325|NCT04684498|Drug|Oseltamivir phosphate capsules|Treatment group vs. Control group
15771326|NCT04684485|Drug|Placebo|Placebo Tablet of SCD-044 product in subjects with moderate to severe atopic dermatitis.
15771327|NCT04684485|Drug|SCD-044_Dose 1|SCD-044 tablets of low dose (Dose 1) in subjects with moderate to severe atopic dermatitis.
15771328|NCT04684485|Drug|SCD-044_Dose 2|SCD-044 tablets of intermediate dose (Dose 2) in subjects with moderate to severe atopic dermatitis.
15771329|NCT04684485|Drug|SCD-044_Dose 3|SCD-044 tablets of high dose (Dose 3) in subjects with moderate to severe atopic dermatitis.
15771330|NCT04684472|Biological|Modified anti-CD19 CAR T cells|intravenous infusion
15771331|NCT04684459|Biological|Dual-targeting HER2 and PD-L1 CAR-T cells|serosal cavity infusion
15771332|NCT04684446|Biological|AZD1222|Participants will receive 1 intramuscular (IM) injection of 5 ×1010 viral particles (vp) (nominal) of AZD1222 on Day 1 followed by rAd26-S 1×1011 viral particles (vp) (nominal) on Day 29 of the study
15771333|NCT04684446|Biological|rAd26-S|Participants will receive 1 IM injection of rAd26-S on Day 1 followed by AZD1222 on Day 29
15771334|NCT04684433|Other|Data extraction from medical files|Data extraction from medical files
15771337|NCT04684407|Procedure|ROOT CANAL TREATMENT|TWO TYPE OF INTRA CANAL MEDICATION PLACEMENT
15771338|NCT04684394|Biological|GEM103|Drug: GEM103 Biological
15771339|NCT04684394|Drug|sham + SoC|SoC defined as 2 mg aflibercept EOM
15771340|NCT04684381|Drug|L-glutamine|Pharmacokinetic study
15771353|NCT04684355|Other|Real-time colonoscopic optical diagnosis for colorectal neoplasm|Colonoscopic optical diagnosis by image enhanced technology has been validated as an excellent tool to predict the histology of colorectal polyps and to differentiate the invasion depth of colorectal cancer.
15771354|NCT04684342|Diagnostic Test|Routine Laboratory investigations|"Complete blood picture
~Liver function test and prothrombine time & concentration.
~Blood urea and creatinine
~Blood glucose, serum Na and K
~CRP and ESR
~Clinical specimens will be collected from patients according to the suspected site of infection (e.g. blood, urine, ascitic fluid, sputum or endo- tracheal aspirates) VITEK 2Compact inflammatory markers"
15771355|NCT04684316|Other|Electronic survey with selective consultations|Participants complete an online questionnaire, after which the 20% employees that mostly need contact with the occupational physician (based on their survey score) are invited to a consultation with the occupational physician.
15771356|NCT04684303|Procedure|Lumbar medial branch radiofrequency ablation neurotomy|Procedure based on positive lumbar Z- joint testing followed by medial branch neurotomy
15771357|NCT04684303|Procedure|Lumbar medial branch cryo ablation neurotomy|Procedure based on positive lumbar Z- joint testing followed by medial branch neurotomy
15771358|NCT04684290|Procedure|Alcohol Septal Ablation|Participants will be treated with alcohol septal ablation.
15771359|NCT04684290|Procedure|Surgical Septal Myectomy|Participants will be treated with surgical septal myectomy.
15771360|NCT04684277|Drug|antidepressant treatment|depression recieve antidepressant treatment
15771361|NCT04684277|Other|antidepressant treatment combined with Internet-based interventions|depression recieve antidepressant treatment combined with Internet-based interventions
15771362|NCT04684264|Other|Heart Failure Prevention Clinic|Heart Failure Prevention Clinic is a pharmacist-directed practice in collaboration with an attending cardiologist that uses evidence-based guidelines to optimize medications and lifestyle interventions for heart failure prevention.
15771363|NCT04684251|Procedure|Coil embolisation of hemorrhoidal arteries.|Coil embolisation of hemorrhoidal arteries as previously described.
15771364|NCT04684238|Drug|Midazolam|Solution for Injection/Infusion
15771365|NCT04684238|Drug|Isoflurane|Inhalation vapour, liquid. Isoflurane delivered by the AnaConDa-S (Anaesthetic Conserving Device)
15771366|NCT04684225|Other|Hand Therapy via Telerehabilitation|Hand Therapy via Telerehabilitation
15771367|NCT04684225|Other|Hand Therapy via home-exercises|Hand Therapy via home-exercises
15837216|NCT04147234|Drug|BI 754091|intravenous infusion
15771368|NCT04684212|Device|LAmbreTM Left Atrial Appendage Closure System|The LAmbre device is a self-expanding occluder, composed of a distal Umbrella and a proximal Cover laser welded together, delivered percutaneously via femoral venous access and trans-septal puncture. The distal Umbrella consists of an elastic nitinol frame and outer PET membrane, and has circumferential anchors to secure the occluder to the left atrial appendage (LAA) wall. The proximal Cover is a disc of elastic nitinol mesh, which seals the orifice of the LAA and minimizes thrombus formation, and includes a PET membrane to prevent the passage of blood into the LAA after implantation.
15771369|NCT04684199|Dietary Supplement|Melatonin|Comparison between melatonin and placebo (2 weeks each) with active and placebo crossover during the study period of 34-36 days.
15771370|NCT04684199|Dietary Supplement|Placebo|
15771371|NCT04684186|Procedure|Endovascular fiducial marker insertion|Fiducial markers will be inserted using an endovascular route
15771372|NCT04684186|Procedure|Bronchoscopic fiducial marker insertion|Fiducial markers will be inserted using an endoscopic route
15771373|NCT04684160|Device|Fixed-bearing TKA|
15771374|NCT04684160|Device|Mobile-bearing TKA|
15771375|NCT04684147|Biological|single dose of CNCT19|Dose: 0.5 x 10^8 CNCT19 Cell Injection via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide
15771378|NCT04684108|Drug|SG301|During study treatment, subjects will receive SG301 treatment via IV infusion once every week at doses of 0.01, 0.03, 0.1, 0.3, 1.0, 2.0, 4.0, 8.0, 12.0 and 16.0mg/kg
15771379|NCT04684095|Behavioral|electronic patient report outcome|ePRO was conducted every two weeks in addition to routine follow-up
15771380|NCT04684082|Device|Colonic irrigation with the Colon Hydromat|"A designated health professional will administer to the patient the colonic irrigation procedure - using the Colon Hydromat device, a CE certified device for colonic irrigation and cleansing before endoscopic procedures."
15771381|NCT04684069|Device|Long-axis syringe free in-plane|Long-axis syringe-free in-plane catheter placement
15771382|NCT04684069|Device|Short-axis out-of-plane|Short-axis out-of-plane catheter placement
15771383|NCT04684043|Device|Percutaneous coronary intervention|PCI was performed using drug-eluting stents
15771384|NCT04684030|Device|Continuous glucose monitoring system(CGMS)|Patients will randomized 1:1 to either continuous glucose monitoring system(CGMS) or conventional self-monitoring of blood glucose (SMBG) group. After the randomization, patients in CGMS group will given education on how to use the device and check the result using the smart phone. The data collected from the sensors were computed to generate the respective ambulatory glucose profiles so as to determine the total numbers of scans conducted during the study period.
15771385|NCT04684030|Device|Self-monitoring of blood glucose (conventional fingerpricking method)|Patients will randomized 1:1 to either continuous glucose monitoring system(CGMS) or conventional self-monitoring of blood glucose (SMBG) group. After the randomization, patients in SMBG group will check their blood glucose by finger pricking method and record the data in a notebook to share the data in their outpatient clinic visit.
15771386|NCT04684017|Drug|Anlotinib hydrochloride|anlotinib 10 mg/day orally (from days 1 to 14 in a 21-day cycle)
15771387|NCT04684017|Drug|Etoposide|100mg/m2 iv on days 1-3 every 21 days for 4 cycles
15771388|NCT04684017|Drug|Carboplatin|AUC 5 iv on day 1 every 21 days for 4 cycles
15771389|NCT04684004|Other|To report number of HF events and deaths|In these two cohorts of study authors will evaluate at 2 years of follow-up the number of HF events and of deaths.
15771390|NCT04683991|Procedure|Subepithelial connective tissue graft|A de-epithelialized connective tissue graft is harvested from the homolateral palate and sutured to the buccal periosteum where the implant is placed.
15771391|NCT04683978|Other|Position|Neck extension
15771392|NCT04683965|Drug|Pemetrexed|Pemetrexed 500 mg/m2 d1
15771393|NCT04683965|Drug|TAS-102|TAS-102, capsule, 35mg/m2, bid,p.o, d1~5,d8~12
15771394|NCT04683965|Drug|Bevacizumab|Bevacizumab 5 mg/kg d1,d14
15771395|NCT04683952|Device|Exercise training with Humified High Flow Nasal Cannula|The experimental group will be trained using HHFNC with the most adequate continuous flow, in a range between 25 and 30 L / min.
15771396|NCT04683952|Other|Exercise training - Control Group|The control group will perform exercise training in spontaneous breathing.
15771397|NCT04683939|Biological|BNT141|Intravenous (IV)
15771398|NCT04683926|Drug|Desmetramadol|Analgesic
15771399|NCT04683913|Behavioral|Foot rotation modification|"The instruction of gait modification provided via teleconferencing sessions (5 over 6 weeks) focusing on increasing toe-in or toe-out angles by as much as is comfortable."
15771400|NCT04683913|Other|Waiting Period - Delayed Group|Participants allocated to the Delayed Group will wait 6 weeks after their initial baseline, then complete a second baseline to provide a control condition. After the second baseline they will enter the intervention.
15771401|NCT04683900|Other|Standard of care + Mediterranean diet (intervention)|"Participants will receive a constipation management handout that is distributed regularly to patients who present with constipation symptoms at an outpatient neurology clinic. The handout recommends increasing fluids daily, as well as increasing physical activity and dietary fiber intake. Laxative medications and recommendations for usage are included.
~Participants will be instructed to include the following in their diet: a) abundant use of olive oil for cooking and dressing dishes; b) consume ≥2 daily servings of vegetables; c) ≥2-3 daily serving of fruits; d) ≥3 weekly servings of legumes; e) ≥3 weekly servings of fish/seafood; f) ≥3 weekly serving of nuts/seeds; g) select white instead of red or processed meats; h) cook at least twice a week with sofrito. Limit consumption of cream, butter, processed meat, sugared beverages, industrial bakery products and desserts, and French fries or chips. For usual drinkers, the main source of alcohol should be wine."
15771402|NCT04683900|Other|Standard of care (control)|Participants will receive a constipation management handout that is distributed regularly to patients who present with constipation symptoms at an outpatient neurology clinic. The handout recommends increasing fluids daily, as well as increasing physical activity and dietary fiber intake. Laxative medications and recommendations for usage are included.
15771403|NCT04683887|Device|Tape application|Application of the tape with lymphatic technique to the fingers, both dorsally and volarly, of wrist fractured patients treated with a forearm cast
15771404|NCT04683874|Device|3D printed tray|3D printed tray
15771405|NCT04683861|Procedure|Spinal cord stimulation|Paddle-shaped Spinal cord stimulation electrode with 16 contacts (AdaptiveStim® 39, 565; Medtronic, USA) will be implanted into the epidural space at the thoracic levels ranging from T10 to T12.
15771406|NCT04683848|Biological|MT-3921|Solution for infusion; Intravenous (IV)
15771407|NCT04683848|Biological|Placebo|Solution for infusion; Intravenous (IV)
15771408|NCT04683835|Device|Neurosteer Aurora system|The system is composed of hardware and software modules that facilitate the capture and interpretation of electrophysiological data as well as enable viewing the processed data in real time and offline. An electrode patch is attached on the subject's forehead to capture the electrophysiological signal. The signal is sent via low energy Bluetooth to an EEG Monitor. The signal is then sent via Wi-Fi to the cloud where the data is stored on a HIPAA compliant server. Data analysis performed in the cloud transforms the electrophysiological signal into easily readable data of brain activity, which is accessible via any web interface
15771409|NCT04683822|Other|Telerehabilitation|Patients will attend telerehabilitation sessions
15771410|NCT04683809|Other|Telerehabilitation|Patients will attend rehabilitation sessions through online programmes for rehabilitation
15771411|NCT04683796|Drug|100% Autologous platelet rich plasma|Patients' blood (36 ml per tube) will be collected in three 50-ml sterile centrifuge tubes containing 4 ml of 3.2% buffered citrate acid for anticoagulation. Tubes will be centrifuged at 350 g for 10 minutes at 20 C. The two upper layers of the centrifuged blood, the plasma and the superficial buffy coat, will be separated in a sterile manner under a laminar air flow hood. A 1.5 ml aliquot of both final blood products will be transferred into identical opaque eye drop bottles, labelled name, hospital number, dated and sealed.
15771412|NCT04683796|Drug|100% Autologous serum|Patients' blood (36 ml per tube) will be collected in three 50-ml sterile centrifuge tubes. The tubes will be left standing in an upright position for 1-2 hours to enable blood clot formation at room temperature (18-25 C). The tubes will be centrifuged at 3000 g for 30 minutes at 20 C. The supernatant serum will be aseptically transferred into a sterile syringe to enable filtration through a 0.2 µm pore size membrane filter under a laminar air flow hood. A 1.5 ml aliquot of both final blood products will be transferred into identical opaque eye drop bottles, labelled name, hospital number, dated and sealed.
15771413|NCT04683757|Other|Establishment of a Survival Prediction Model|a nomogram to predict the survival of patients with ER positive / HER-2 negative advanced breast cancer
15771414|NCT04683744|Other|Semi-structured interviews-Patients|The interview guide will consist of questions to elicit the patients thoughts about getting preventive healthcare during the COVID-19 pandemic, including perception of risk, barriers to getting healthcare, and information needed for decision making.
15771415|NCT04683744|Other|Semi-structured interviews-Health system|The interview guide will consist of questions to elicit thoughts from health system leadership, providers, and staff about implementing decision aids, provider notifications, and cancer risk assessments in their health center or healthcare system. The questions may be specific to colorectal cancer screening or more generally about other cancer screenings. The investigators may also ask questions about cancer screening initiatives their health center or healthcare system engaged in during the COVID-19 pandemic.
15771416|NCT04683731|Behavioral|Decision aid without personalized message|The decision aid without personalized message consists of a PowerPoint presentation converted to mp4 (video) with text, photos, and an audio track, that is advanced by the viewer and can be viewed online. It begins with a 60 sec video on CRC screening produced by the Centers for Disease Control and Prevention (CDC), followed by slides summarizing the advantages and disadvantages of colonoscopy and stool testing with the fecal immunochemical test (FIT) and DNA+FIT (Cologuard). The presentation is approximately 10 minutes long.
15771417|NCT04683731|Behavioral|Decision aid with personalized message|The decision aid with personalized message will first present the decision aid without personalized message followed by additional PowerPoint slides converted to mp4 (video) with text, photos, and an audio track briefly explaining the risk tool, the participant's score on the 5 risk factors, total score, ACN risk, and implications for screening and test choice. The presentation is approximately 14 minutes long.
15771418|NCT04683731|Behavioral|Provider notification without personalized message|Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
15771419|NCT04683731|Behavioral|Provider notification with personalized message|Providers will receive a message informing them that their enrolled patient is due for CRC screening. The notification will also include the patient's ACN risk (very low, low, moderate, high-average) and implications for screening decisions and test choice. Links to a web landing page containing a more detailed explanation of the risk tool and additional references will be included. The notification will be sent to them through the EHR within 24 hours of their visit with the enrolled patient.
15771420|NCT04683718|Device|Permanent implant of a BIOTRONIK Prospera™ SCS (Spinal Cord Stimulation) System with HomeStream™ Remote Management|The Prospera™ SCS System is a rechargeable, 16-electrode, MRI conditional Spinal Cord Stimulation system that delivers electrical stimulation to the dorsal column of the spinal cord for the treatment of chronic intractable pain of the trunk and/or limbs.
15771421|NCT04683705|Diagnostic Test|Ultrasound|"High-resolution ultrasound evaluation of the shoulder region to recognize the biceps tendon, subscapularis tendon, supraspinatus tendon, and infraspinatus tendon.
~High-resolution ultrasound evaluation for the C5, C6 and C7 nerve roots and the suprascapular nerve over the supraclavicular fossa , in the supraspinatus fossa and in the infraspinatus fossa to obtain the nerve cross-sectional image.
~Collecting the shoulder pain-related information, including physical examination results (bicipital groove tenderness, Speed test, Yergason's test, Empty can test, Neer test, Hawkins-Kennedy test and painful arc test) and status of disability using Shoulder Pain and Disability Index (SPADI)."
15837765|NCT04142762|Drug|Rifampin|Rifampin capsules
15771424|NCT04683679|Drug|Pembrolizumab|Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks for 3 doses
15771425|NCT04683679|Drug|Olaparib|Olaparib will be administered twice daily continuously without breaks on a 21-day (3 week) cycle length, for a total of 2 cycles. Olaparib tablets will be administered bid (2 x 150 mg tablets twice daily; total 600 mg daily) on continuous days without interruption for 2 cycles. Each 3 week period constitutes one cycle.
15771426|NCT04683679|Radiation|Radiation|The dose of radiation will be 8-9 Gy x 3 fractions. Radiation therapy will begin on C1D2-7. For tumors that are too large for this schedule, an accomodation of 30 Gy in 6 Gy per fraction is allowed, a schedule commonly used at MSK.
15771427|NCT04683666|Procedure|Bariatric surgery|Laparoscopic Roux-en-Y gastric bypass (LRYGB) or laparoscopic sleeve gastrectomy (LSG), as primary bariatric procedures, were performed. ^Postoperative complications were assessed.
15771428|NCT04683653|Radiation|Hypofractionated Radiation|Radiation treatment in which the total dose of radiation is divided into large doses and treatments are given less often. Hypofractionated radiation therapy is given over a shorter period of time (fewer days or weeks) than standard radiation therapy.
15771429|NCT04683653|Other|Clinical Follow-Up and Assessments|"At each visit, the subject will be evaluated for any signs of their endometrial cancer or symptoms returning (clinical disease recurrence) and any negative side effects associated with their prior radiation treatment. Study participants will also be asked to fill out a survey regarding bowel/urinary habits and quality of life questionnaires (known as the EPIC questionnaire) during these visits. The data collected during these clinical follow up visits will be used to determine how effective hypofractionated/shortened whole radiation therapy is for treating endometrial cancer."
15771430|NCT04683640|Dietary Supplement|GABA|Daily oral GABA for 4 weeks
15771431|NCT04683640|Drug|Placebo|Daily oral Placebo for 4 weeks
15771432|NCT04683627|Drug|Diclofenac sodium active topical patch|A topical patch with diclofenac sodium will be evaluated against the placebo patch for the treatment of OA pain of the knee
15771433|NCT04683627|Drug|Placebo patch|A placebo patch without diclofenac sodium will be used for the placebo arm.
15771434|NCT04683614|Drug|Norepinephrine|5 mic/kg/hr norepinephrine
15771435|NCT04683614|Biological|Fresh frozen plasma|early administration of fresh frozen plasma
15771436|NCT04683601|Other|Thoracoscopic esophagectomy in left decubitus|Making surgical field at thoracoscopic esophagectomy in left decubitus
15771437|NCT04683588|Other|Nursing Coaching|Different strategies, methods and training techniques are used in the implementation of preoperative and postoperative nursing care of surgical patients scheduled for total knee arthroplasty surgery. One of them is patient coaching. Coaching is a method that increases the quality of nursing care.While the coaching strategy contributes more to the recovery process of the patient with the role of the case manager of the nurse, it provides a reduction in the problems related to surgery (pain, nausea-vomiting, mobilization problems), reduction in repeated hospitalizations and positive contributions to the cost.
15771438|NCT04683575|Drug|Selenium Yeast|oral medication
15771439|NCT04683575|Drug|Placebo|oral medication
15771440|NCT04683562|Other|Pregnant women at 28-32 weeks|Pregnant women at gestational age 28-32 weeks
15771441|NCT04683562|Other|at delivery|women delivered at term
15771442|NCT04683549|Diagnostic Test|HPV serum level and FDG PET CT in patients with cervical cancer treated with radical radiochemotherapy|"Locally advanced non-operable newly diagnosed FIGO stage IB-IVA cervical cancer patients planned for definitive radiochemotherapy will be accrued to study and will have:
~FDG PET Scan before treatment and 3 months after treatment
~Pre- treatment DNA from the neoplastic time preserved in the form of paraffin blocks to determine HPV status
~Blood sample to measure HPV DNA at time point baseline (before treatment), in the middle of treatment and at the end of definitive radiochemotherapy,
~[F-18] - FDG PET scan before treatment and 3 months post completion of radiochemotherapy."
15771443|NCT04683536|Procedure|Obturator nerve blockade|We performed spinal anesthesia combined with ultrasound guided obturator nerve blockade according to the localization of bladder cancer in patients with lateral wall localized non-muscle invasive bladder cancer
15771444|NCT04683523|Other|Exercise|Resistance training using dumbbells and therabands
15771453|NCT04683497|Other|Contrast-enhanced Intraoperative Ultrasound|Intraoperative ultrasound with the administration of a contrast agent I.V.
15771454|NCT04683484|Biological|Nanocovax|Recombinant Protein spike (s) SARS-CoV-2 and adjuvant (0,5 mg Al PO4)
15771455|NCT04683484|Biological|Placebo|0,5 mg Al PO4
15771456|NCT04683471|Device|Stimulator|Neuromodulation
15771457|NCT04683471|Device|Sham|Sham
15771458|NCT04683458|Device|Drug-coated device|The endovascular (intraluminal) application of a medical-device that was coated with paclitaxel
15771460|NCT04683445|Drug|Trastuzumab|Trastuzumab，8mg/kg for the first dose，6mg/kg for the following dose，Intravenous infusion，3-week cycle
15771461|NCT04683445|Drug|pertuzumab|Pertuzumab，，840mg for the first dose，420mg for the following dose，Intravenous infusion，3-week cycle
15771462|NCT04683445|Drug|Pyrotinib|Pyrotinib，400mg，oral，every day
15771463|NCT04683445|Drug|Pembrolizumab|Pembrolizumab，200mg，Intravenous infusion，3-week cycle
15771464|NCT04683445|Drug|Camerlizumab|Camerlizumab，200mg，Intravenous infusion，3-week cycle
15771465|NCT04683419|Device|Modified Thoracoscopic pleural Cryobiopsy|"Thoracoscopic pleural biopsy will be taken with a modified technique raising of the parietal pleura by injection of saline, adrenaline and xylocaine, then taking the biopsy via a cryoprobe"
15771466|NCT04683406|Drug|ZSP1273 600 mg|3 X 200-mg tablet taken orally
15771467|NCT04683406|Drug|Placebo to Oseltamivir|Placebo capsules matching oseltamivir2 X 75-mg
15771468|NCT04683406|Drug|Oseltamivir(oral)|2 X 75-mg tablet taken orally
15771469|NCT04683406|Drug|Placebo to ZSP1273|Placebo capsules matching ZSP1273 600 mg
15771470|NCT04683367|Procedure|laparoscopic surgery|laparoscopic repair of hernia
15771471|NCT04683354|Drug|HL-085|HL-085 is a MEK inhibitor with potential indication for cancers. It will be given twice or three times daily continuously in the study until disease progression; or the risks outweigh the benefits, if the subject continues study treatment; or subjects with poor compliance; or subjects need to receive or have already started alternative antitumor drugs; or Subjects who need to receive or have already started alternative any other concomitant medication and/or treatment, which would significantly impact their safety; or interruption of IP administration for more than 14 days due to IP-related AEs.
15771472|NCT04683341|Drug|Tenofovir Alafenamide Tablets|Approximately 100 adults, cirrhotic or non-cirrhotic (capped at 50), CHB patients with hepatic decompensation, will receive initial treatment (Arm A) with or switch (Arm B) to TAF 25 mg/day for 144 weeks. For Initiation Arm (Arm A), CHB patients with hepatic decompensation, who are currently not under HBV antiviral treatment will be enrolled. For Switch Arm (Arm B), CHB patients who are currently with hepatic decompensation and virally suppressed under HBV NUC treatment (HBV DNA < 20 IU/mL) will be enrolled.
15771473|NCT04683328|Biological|SCTA01|Recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
15771474|NCT04683328|Biological|SCTA01 Placebo|The excipients of SCTA01
15771475|NCT04683315|Drug|mFOLFIRINOX Treatment Regimen|This therapy will be 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX).
15771476|NCT04683315|Drug|Gemcitabine/Nab-paclitaxel Treatment Regimen|This regimen will be nab-paclitaxel and gemcitabine.
15771477|NCT04683315|Radiation|Chemoradiation|50.4 Gy in 28 fractions.
15771478|NCT04683302|Device|3DUS biplanar catheterization|biplanar view of both short and long axis view of the internal jugular vein improves anatomical awareness and potentially improves safety of venous catheterization
15771479|NCT04683302|Device|2D US catheterization|2D short axis internal jugular vein catheterization
15771480|NCT04683289|Procedure|trabeculotomy|performing partial unroofing of the SC and viscoelastic injection into the 2 ostia of the canal. This was followed by connecting the scalemm canal to the anterior chamber
15771481|NCT04683276|Procedure|pars plana vitrectomy with ILM inverted flap|Complete vitrectomy was done with the aid of triamcinolone acetonide followed by fluid-air exchange. Staining of the ILM was carried with 0.05% solution of Brilliant Blue dye (BBG), (Ocublue plus, Aurolab, India) for 30 seconds, ILM peeling was proceeded leaving a circle of ILM measuring approximately 1-2 DD in SF groups and >2 to 4DD in LF group, centered around the MH. The ILM outside the parafoveal area was peeled to the arcade. The ILM around the hole was then detached from the retina up to the edge of the hole. The ILM flap around the edge of the hole was inverted over the MH using a scraper.
15771482|NCT04683263|Other|Placebo|topical cream with same composition as Intervention but without active ingredients
15771483|NCT04683263|Other|Fisiocrem|a natural topical composition containing Arnica montana, Hypericum perforatum, Calendula officinalis, Melaleuca sp. and menthol
15771484|NCT04683250|Drug|TAS0953/HM06|Phase 1: oral, starting dose 20mg twice a day, until recommended phase 2 dose, continuous daily dosing, cycles lasting 21 days
15771485|NCT04683250|Drug|TAS0953/HM06|Phase 2: oral, recommended dose twice a day, continuous daily dosing, cycles lasting 21 days
15771486|NCT04683237|Drug|Liraglutide Injection|Initiate liraglutide with a dose of 0.6 mg daily for one week. After one week at 0.6 mg per day, increase the dose to 1.2 mg daily in a week, and increase the dose to 1.8 mg daily after at least one week of treatment with the 1.2 mg daily dose. If the patients can not tolerate 1.8mg per day, decrease the dose to the max tolerable dose.
15771487|NCT04683237|Drug|Megestrol Acetate 160 MG|160mg po qd
15771488|NCT04683224|Biological|UB-612|100 µg [microgram] of an experimental study vaccine
15771489|NCT04683224|Other|Placebo|Placebo is a 0.9% sodium chloride (normal saline) injection
15771490|NCT04683211|Other|Evaluation of iodine supplementation|survey of iodine supplementation
15771491|NCT04683198|Drug|camrelizumab|Camrelizumab intravenous infusion was administered at a dose of 200 mg on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4/6) and maintenance phase ,until PD.
15771492|NCT04683198|Drug|Apatinib Mesylate|Apatinib capsules 250 mg given orally , once daily in 21-day cycle and maintenance phase,until PD.
15771493|NCT04683198|Drug|Carboplatin|Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4/6).
15771494|NCT04683198|Drug|Etoposide|Etoposide intravenous infusion was administered at a dose of 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle during the induction phase (Cycles 1-4/6).
15771495|NCT04683185|Drug|E6742|E6742 tablets.
15771496|NCT04683185|Drug|Placebo|E6742-matched placebo tablets.
15771620|NCT04682262|Procedure|Cervical dilatation|Patients undergo to cervical dilatation prior to the hysteroscopy under general anaesthesia with using Hegar dilator (no.10)
15771621|NCT04682249|Drug|Systemic Chemotherapy|Systemic Chemotherapy (Oxaliplatin#5-fluorouracil and leucovorin)
15771622|NCT04682249|Drug|Sintilimab|Sintilimab
15771623|NCT04682249|Drug|Apatinib|Apatinib
15771804|NCT04680884|Drug|Experimental for antifungals|IV placebo of methylprednisolone + IV isavuconazole (200 mg every 8 hours for 2 days followed by 200 mg per day until ICU discharge or for a total duration of 14 days)
15771497|NCT04683172|Device|Active Transcranial Direct Current Stimulation|"tDCS consists of delivering a low-intensity (1 to 2 milliamperes) direct electrical current by means of a pair of electrodes (anode and cathode) applied to the scalp. Electrodes generally have a diameter (round electrode) or a diagonal (rectangular electrodes) ranging from 2 to 3.5 cm.
~To stimulate a given cortical zone, the anode is placed over of the selected zone, generally identified by means of an EEG headset (10/20 System Positioning). For the treatment of pain, the anode is placed over the primary motor cortex (M1) on the contralateral side to the pain or on the left side in patients with diffuse pain. The cathode is placed over a supposedly neutral cortical zone, usually the contralateral supraorbital cortex with respect to the anode. In this study, the stimulation intensity will be 1.5 mA using round sponge electrodes 3.5 cm in diameter."
15771498|NCT04683172|Device|Sham Transcranial Direct Current Stimulation|"The tDCS device has a Sham mode that allows for true placebo stimulation. A simulated session is thus designed as a real stimulation session without its effects. Sensations similar to tDCS are created by generating currents only at the start of the session.
~Same modalities as for the Active tDCS procedure will therefore be put in place: a pair of electrodes (anode and cathode) are applied to the scalp.To stimulate a given cortical zone, the anode is placed over of the selected zone, generally identified by means of an EEG headset (10/20 System Positioning). For the treatment of pain, the anode is placed over the primary motor cortex (M1) on the contralateral side to the pain or on the left side in patients with diffuse pain. The cathode is placed over a supposedly neutral cortical zone, usually the contralateral supraorbital cortex with respect to the anode."
15771499|NCT04683159|Drug|Brimonidine Tartrate 0.15% Oph Soln|1 drop of brimonidine 0.15% (~0.05mL) 15 minutes prior to surgery
15771500|NCT04683159|Drug|Brimonidine Tartrate 0.025% Oph Soln|1 drop of brimonidine 0.025% (~0.05mL) 15 minutes prior to surgery
15771501|NCT04683146|Drug|Hand antisepsis with Propanolol- 1 60%.|"Pre-washing for one minute with neutral soap to remove the transient flora.
~Hand antisepsis using Propanolol-1 60% in both hands.
~Bacterial sample collection from right hand.
~Sterile surgical glove in both hands.
~Bacterial sample collection from left hand three hours later"
15771502|NCT04683146|Drug|Hand antisepsis with a solution of alcohol, chlorhexidine digluconate and potassium sorbate.|"Pre-washing for one minute with neutral soap to remove the transient flora.
~Hand antisepsis using a solution of alcohol, chlorhexidine digluconate and potassium sorbate.
~Bacterial sample collection from right hand.
~Sterile surgical glove in both hands.
~Bacterial sample collection from left hand three hours later."
15771503|NCT04683133|Diagnostic Test|Optical coherence tomography assessment|Optical coherence tomography assessment of coronary arteries with intermediate to severe stenosis
15771504|NCT04683120|Diagnostic Test|Zenith FLIM Diagnostics|In-vitro
15771505|NCT04683107|Other|Eccentric protocol|Participants in this arm will perform progressive eccentric exercise protocol
15771506|NCT04683107|Other|Isometric protocol|Participants in this arm will perform progressive isometric exercise protocol
15771507|NCT04683081|Device|mechanical cervical ripening|mechanical cervical ripening methods have been used to make the cervix more eligible for vaginal delivery
15771511|NCT04683042|Device|Transcutaneous Electrical Nerve Stimulation (TENS) with PT|Use of TENS units along with routine PT therapy
15771512|NCT04683042|Other|PT only|Routine PT therapy only
15771513|NCT04683029|Drug|Guselkumab Dose 1|Guselkumab Dose 1 will be administered intravenously.
15771514|NCT04683029|Drug|Guselkumab Dose 2|Guselkumab Dose 2 will be administered subcutaneously.
15771515|NCT04683029|Drug|Placebo|Placebo will be administered intravenously or subcutaneously.
15771516|NCT04683016|Other|Questionnaires|"Patients will be asked two sets of questions:
~questionnaire about their perception of periodontal disease (Brief Illness Perception Questionnaire; 9 questions, answers will be registered on a scale of 0 to 10);
~Oral Health Impact Profile 14 (OHIP-14) questionnaire.
~All these two sets of questions will be asked before and after non surgical periodontal therapy"
15771517|NCT04683003|Biological|TAK-755|Participants in prophylaxis cohort will receive IV infusions of 40 IU/kg TAK-755 during Q1W or Q2W up to 3 years. On-demand cohort participants will receive an initial IV infusion of 40 IU/kg followed by 20 IU/kg on Day 2 and 15 IU/kg daily until 2 days after the acute event has resolved (approximately one month).
15771518|NCT04682990|Device|Tor Vergata Electronic Nose (TV eNose)|Participants will be asked to perform a breath sampling with a nose clamp in Alveolar sampling bag. This exhaled breath in the sampling bag will be analyse with the TV eNose
15771519|NCT04682990|Other|Survey & Physical Exam|Perform a oriented survey for risk factors, symptoms and a complete physical exam.
15771520|NCT04682990|Diagnostic Test|TB LAMP test|Collection of Sputum samples and Perform TB-LAMP (temperature-independent way of amplifying DNA from TB organisms)
15771521|NCT04682990|Other|Sputum Samples|Sputum samples for Ziehl Neelsen smear or Culture in L-J (if required by the medical staff)
15771522|NCT04682990|Other|Chest X-Ray|Perform anteroposterior chest X-ray (if required by the medical staff)
15771523|NCT04682990|Other|Follow Up 5 days after beginning of Tx.|"Following the usual planning of the center for Positive TB Patients, they will be asked to come 5 days after initiation of treatment, to perform another measurement with the device.
~Also will perform a Medical History, including Symptom based Survey, Physical Exam, to determine progress of treatment."
15771524|NCT04682990|Other|Follow Up & 15 days after beginning of Tx.|"Following the usual planning of the center for Positive TB Patients, they will be asked to come during treatment, to perform another measurement with the device.
~Also will perform a Medical History, including Symptom based Survey, Physical Exam, to determine progress of treatment."
15771525|NCT04682990|Other|Follow Up & 30 days after beginning of Tx.|"Following the usual planning of the center for Positive TB Patients, they will be asked to come during treatment, to perform another measurement with the device.
~Also will perform a Medical History, including Symptom based Survey, Physical Exam, to determine progress of treatment."
15771526|NCT04682977|Other|IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning)|IPROACTIF (Integrated PRimary Care and Occupational Therapy for Aging and Chronic Disease Treatment to preserve Independence and Functioning) is an intervention designed to be delivered in primary care settings by an on-site occupational therapist. Based on the premise of preventing the physical and cognitive decline that is associated with aging and chronic disease, the 12-week intervention includes a comprehensive assessment of ADL functioning and ten intervention sessions addressing disease management, physical activity and executive functioning.
15771527|NCT04682977|Other|Usual primary care services|Usual primary care services might include monitoring of vitals and other relevant laboratory testing, prescription of medications for chronic disease management, as well as counseling for lifestyle changes.
15771528|NCT04682964|Drug|Nebulizer inhalation irrigation of the mucous membranes of the tonsils with a bacteriophage.|Bacteriophage therapy using a liquid complex of pyobacteriophages (pyobacteriophage complex liquid - PСL). PСL was administered via nebulizer inhalation to irrigate the mucous membranes of the tonsils. In total, 5 ml of PCL was inhaled for up to 10 minutes once every 5 days.
15771529|NCT04682951|Procedure|Decompressive Craniectomy|
15771530|NCT04682925|Other|skin care arm of where evidence-based practices in the implementation guide|"The nasal mucosa and nasal skin under the nasogastric tube will be cleaned and dried twice a day with a pH-compatible cleanser.
~A water-based moisturizing cream will be applied to the nasal skin under the nasogastric tube twice a day, after care with a pH-compatible cleanser.
~Spray skin barrier will be applied twice a day after applying water-based moisturizing cream to the nasal skin under the nasogastric tube.
~The nasal mucosa and nasal skin under the nasogastric tube will be evaluated twice daily for signs of pressure-related injury. All these care interventions applied to the skin care arm will be applied together with the doctor and nurse responsible for the treatment and care of the patient."
15771531|NCT04682925|Device|hydrocolloid (Convatec Granuflex-extra thin) dressing|The nasal skin of the patients and the surrounding skin will be cleaned with a pH-compatible cleaner, dried and a new hydrocolloid cover will be applied once a day. All these care interventions applied to the hydrocolloid dressing arm will be applied together with the physician and nurse responsible for the treatment and care of the patient.
15771532|NCT04682925|Other|control|In routine care, the skin under the nasogastric tube is evaluated once a day for redness and wound formation by the nurse responsible for the patient's care and is cleaned and dried with appropriate cleaners.
15771533|NCT04682899|Drug|procalcitonin-guided antibiotic therapy|In procalcitonin group, clinican make a decision of antibiotic precription based on the results of procalcitonin.
15771534|NCT04682899|Drug|guideline-guided antibiotic therapy|In guideline group, clinican make a decision of antibiotic precription based on the recommendations of GOLD guideline.
15771535|NCT04682886|Diagnostic Test|diagnosis|there is no intervention diagnosis or treatment for patients
15771536|NCT04682873|Drug|Enisamium Iodide|"Capsule formulations of the active product (enisamium iodide 500 mg; Investigational medicinal product 1 [IMP-1]).
~1 capsule Amizon® Max contains: enisamium iodide 500 mg.
~Amizon® Max (active ingredient: enisamium iodide; IMP-1 will be administered as 1 capsule 4 times a day, every 6 hours (total dose 2,000 mg per day). Capsule will be taken orally (swallowed whole), together with a sufficient amount of liquid (preferably water).
~Treatment will start on Day 1 (randomization) and for up to 168 hours after the first dose administration i.e. Day 7 or Day 8. The site staff will ensure that the IMP (1 capsule) is taken every 6 hours by the study subjects.
~For documentation purposes, the IMP-1 packs (empty blister / blister with unused capsules) will be kept at the site and drug accountability forms are completed."
15771537|NCT04682873|Drug|Placebo|"Capsule formulations of the reference product placebo Amizon® Max (IMP-2), will be identical in appearance (size, shape, and color), taste, and smell as the active formulation capsule.
~1 capsule placebo Amizon® Max contains: placebo (no active substance).
~Amizon® Max placebo (IMP-2), will be administered as 1 capsule 4 times a day every 6 hours. Capsule will be taken orally (swallowed whole), together with a sufficient amount of liquid (preferably water).
~Treatment will start on Day 1 (randomization) and for up to 168 hours after the first dose administration i.e. Day 7 or Day 8. The site staff will ensure that the IMP (1 capsule) is taken every 6 hours by the study subjects.
~For documentation purposes, the IMP-2 packs (empty blister / blister with unused capsules) will be kept at the site and drug accountability forms are completed."
15771538|NCT04682860|Drug|Hyoscine N Butylbromide|Hyoscine N butylbromide injection for the treatment of abdominal pain in acute gastroenteritis
15771539|NCT04682860|Other|Placebo|2 ml of normal saline injection as placebo
15771540|NCT04682847|Drug|Ferumoxytol injection|This is a prospective observation study of 1.5T MR-Linac-SPION imaging with Ferumoxytol for radiotherapy planning in patients with pre-existing liver condition in order to increase safety of liver SBRT with assessment of tumor and hepatic parenchyma response.
15771541|NCT04682834|Drug|Sulopenem Etzadroxil/Probenecid|Individual Patients
15771543|NCT04682808|Drug|FCN-338|FCN-338 will be given orally in ascending doses starting at 50 mg QD until the maximum tolerated dose or recommended dose is reached.
15771544|NCT04682795|Device|Needle-free injector|Using needle-free injector as insulin carrier to treat T2DM
15771545|NCT04682795|Device|Insulin pen|Using insulin pen as insulin carrier to treat T2DM
15771546|NCT04682782|Drug|Esketamine|Esketamine is infused through the whole period of surgery. Participants randomized to the esketamine arm will receive 1 mg/ml solution infused at 0.1 mg/kg/hour (0.1 ml/kg/h) .
15771547|NCT04682782|Drug|Saline|Participants randomized to the placebo arm will receive 0.9 mg/ml sodium chloride, infused at a rate of 0.1 ml/kg/hour throughout the surgery.
15771548|NCT04682769|Other|Other|Patients with Coronary Heart Disease and Depressive Disorder are receiving routine treatment by their physician.
15771549|NCT04682756|Diagnostic Test|The model of machine learning|Early diagnosis of NTEMI patients by machine learning model
15771550|NCT04682743|Drug|paracetamol|received intravenous one gram of paracetamol over a 15-minute period,
15771551|NCT04682743|Drug|ondansetron|received intravenous 8 mg of ondansetron over a 15-minute period.
15771553|NCT04682730|Behavioral|Deliberative Loop|"The investigators will give background information to the stakeholders before they engage in the Deliberative session.
~Stakeholders from a given clinic will come together for a Deliberative session (i.e., facilitated conversation), enabling them to hear the full range of perspectives held by their fellow colleagues and to share their own perspective regarding how best to implement the guideline in small-group discussions.
~Following the Deliberative session, each stakeholder will have the opportunity to record their opinions regarding possible implementation interventions. The investigators will share these opinions with the clinic's decision-makers to help guide their decision-making about which implementation interventions to deploy. If a stakeholder happens to be absent the day of their clinic's Deliberative session, they will still have the opportunity to complete the survey."
15771554|NCT04682717|Device|perfusion index monitoring for postinduction hypotension|Hemodynamic parameters will be recorded at 1-min intervals till 10 min after intubation. Hypotension will be defined as a drop in SBP to <30% of baseline or absolute MAP <60 mmHg. MAP <55 mmHg (severe hypotension) will be treated immediately by rapid intravenous fluid administration (10 ml/kg) and ephedrine sulphate 6 mg IV boluses. Bradycardia will be defined as HR <50 bpm or decrease by more than 30% below baseline value, whichever will be lower and will be treated with atropine 0.6 mg IV boluses. The incidence of hypotension will be calculated in 2 sets - 5 min after induction of anesthesia (effect of induction agent) and first 15 min after induction (effect of induction process and endotracheal intubation).
15771555|NCT04682704|Device|Parasym|Tragus stimulation
15771556|NCT04682691|Drug|Erythromycin (400mg)|parturients will receive oral Erythromycin (400mg)
15771557|NCT04682691|Drug|metoclopramide (10mg)|will be receive oral metoclopramide (10mg)
15771558|NCT04682691|Dietary Supplement|naturally flavored water|will be receive naturally flavored water
15771559|NCT04682678|Procedure|Implantation of electrodes for Spinal cord stimulation|The implantation of electrodes for SCS at the epidural thoracic level connected to a neurostimulator at the abdominal level will be performed under general anaesthesia (hospitalization for 3 days in the Neurosurgery Department, CHUGA) in a maximum delay of 1 month following the preoperative assessment. During the first postoperative month, the optimization of SCS parameters will be performed by an experienced movement disorders neurologist.
15771560|NCT04682665|Drug|Icosapent Ethyl Oral Capsule|Soft gelatin capsules containing 1g pure EPA-EE. Administered as 4g per day to be taken as 2 capsules in the morning and 2 capsules in the evening.
15771561|NCT04682665|Other|Placebo|Soft gelatin capsules containing light mineral oil. 4 capsules to be taken per day (2 in the morning and 2 in the evening).
15771562|NCT04682652|Device|Embozene MicroSpheres|Embozene is a medical device made by Boston Scientific approved in the United States for the treatment of hypervascular tumors and arteriovenous malformations. It consists of thousands of microscopic spheres that are injected into the artery in the knee going to the region of pain. One of the causes of pain in the setting of knee arthritis is increased blood flow going to the specific area of pain. The goal of this procedure is to decrease the blood flow (embolize) to the specific region of the knee that is causing your pain. This is done by infusing Embozene particles into the specific blood vessel (genicular artery) supplying the area of pain in the knee.
15771563|NCT04682639|Drug|Etrasimod|Participants will receive etrasimod tablet by mouth, once daily during the 24-week Double-Blind and 28-week Extension Treatment Periods.
15771564|NCT04682639|Drug|Placebo|Participants will receive etrasimod matching placebo tablet by mouth, once daily during the 24-week Double-Blind Treatment Period.
15771565|NCT04682639|Drug|Etrasimod|Participants will receive etrasimod tablet by mouth, once daily during the 28-week Extension Treatment Period.
15771566|NCT04682626|Dietary Supplement|Soft gelatin capsules each contains 50 000 IU VD3 (cholecalciferol) equivalents to 1.25 mg.|Soft gelatin capsules each contain 50 000 IU VD3 (cholecalciferol) equivalents to 1.25 mg.
15771567|NCT04682613|Behavioral|"Experimental: Prevention Program young In Favor of Myself, active teachers"|"Prevention program: young In Favor of Myself, with teacher participation"
15771568|NCT04682613|Behavioral|"Experimental: Prevention Program young In Favor of Myself, no teacher involvement"|"Prevention program: young In Favor of Myself, without teacher participation"
15771569|NCT04682600|Device|Liver Incytes System|The Liver Incytes System uses the Shear Wave Absolute Vibro-Elastrography (S-WAVE) method. The imaging procedure of the Liver Incytes system is similar to a traditional ultrasound scanning procedure or FibroScan, in which the patient is asked to lie supine on an examination bed, with the operator seated next to them. A vibration source is placed under the patient, between the patient and the bed to induce shear waves in the liver. Ultrasound imaging through the patient ribs is used to track the displacements of these waves. Through tracking of the displacements, the shear wave velocity and tissue stiffness can be calculated. The use of volumetric multi-frequency imaging increases the amount of liver scanned
15771570|NCT04682587|Drug|Axitinib|Inlyta, axitinib
15771571|NCT04682587|Drug|Avelumab|Avelumab, Bavencio
15771572|NCT04682587|Drug|Pembrolizumab|Pembrolizumab, Keytruda
15771573|NCT04682574|Drug|Vitamin C|mega dose is given to the selected critically ill patients
15771574|NCT04682561|Behavioral|Supportive Trauma Exposure Preparation Program|The Supportive Trauma Exposure Preparation Program is based on the theory that the ability to set compassionate boundaries will enhance acceptance of the reality of trauma in the workplace, and will also increase the cognitive/emotional/physical energy needed to engage in adaptive emotional strategies in response to trauma exposure. Therefore, the goal of therapy is to learn to set compassionate boundaries and engage with oneself and others from a perspective of self-empowerment and acceptance of life events. Concepts and skills will be addressed through the following modules: 1) understanding of trauma and its effects, 2) personal rights and boundaries, 3) emotional literacy, 4) distress tolerance and emotion regulation skills building, 5) communication skills building, 6) self-compassion and acceptance, and 7) enhancing self-care.
15771575|NCT04682535|Other|Social relationships|Exposure to social interactions with spouse, friends, and family. Perceived loneliness, emotional strain, and emotional support.
15771649|NCT04682041|Dietary Supplement|Bovine Plasma-Derived Immunoglobulin Concentrate|EnteraGam® 10.0 g, containing 5.0 g of serum-derived bovine immunoglobulin/protein isolate (SBI) BID (every 12 hours) for 2 weeks.
15771650|NCT04682041|Other|Standard of care|Standard of care PSMAR protocol for COVID-19 patients.
15771577|NCT04682509|Drug|Glecaprevir/pibrentasvir|Manufacturer is AbbVie, Inc., North Chicago, IL Mavyret® is commercially available and FDA approved for the treatment of HCV genotype 1, 2, 3, 4, 5, or 6 infection in patients without cirrhosis or with compensated cirrhosis and also for the treatment of adult patients with HCV genotype 1 infection who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor. An immediate release bilayer oral tablet containing a fixed-dose combination of 100 mg of glecaprevir and 40 mg of pibrentasvir. The daily dose of glecaprevir/pibrentasvir used will be the standard FDA approved dose: 3 tablets taken once daily (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg).
15771578|NCT04682496|Procedure|Intratendon vascularization|Ultrasonic exploration by power-Doppler of the intratratendon vascularization, making longitudinal cuts of the patellar tendon and with previously pre-established Doppler optimization parameters for all patients. The optimization parameters of the power-Doppler signal will be set at a Doppler frequency of 6.7 MHz, pulse repetition frequency (PRF) of 0.7 kHz. The lowest wall filter and a standardized gain just below the level that produces random noise will be applied. This examination will be repeated several times with different probe pressures, which will be quantitatively adjusted through the force sensor and maintained with the articulated arm. A 4-second static video will be recorded of the longitudinal section that presents a higher Doppler signal in each of the scans at different probe pressures.
15771579|NCT04682483|Drug|Vasopressor|The vasopressors include phenylephrine, norepinephrine, epinephrine, dopamine and vasopressin.
15771580|NCT04682483|Drug|Inotrope|Inotropes include dobutamine and milrinone.
15771581|NCT04682483|Device|Acute Mechanical Circulatory Support Devices|Acute Mechanical Circulatory Support devices include ECMO (VV), ECMO (VA), Impella CP, Impella 2.5, Impella 5.0, Impella 5.5, Impella RP, IABP, Centrimag, Tandem Heart and ProTek Duo.
15771582|NCT04682470|Other|No intervention ; observational|No intervention; observational
15771583|NCT04682444|Drug|Enisamium Iodide|Patients ingested Amizon tablets after meal without chewing as follows: 2 tablets (total dose 0.5 g) 3 times a day, for 7 days. Each tablet contains 0.25 g of Nmethyl- 4-N-methyl-4-benzylcarbamidopyridinium iodide (INN enisamium iodide).
15771584|NCT04682444|Drug|Placebo|Patients ingested placebo tablets after meal without chewing in the dose 0.5 g (2 tablets), 3 times a day, for 7 days.
15771585|NCT04682431|Drug|PY159 Single agent dose level 1|Dose of PY159 as a single agent given in a standard 3+3 design.
15771586|NCT04682431|Drug|PY159 Single agent dose level 2|Dose of PY159 as a single agent given in a standard 3+3 design.
15771587|NCT04682431|Drug|PY159 Single agent dose level 3|Dose of PY159 as a single agent given in a standard 3+3 design.
15771588|NCT04682431|Drug|PY159 Single agent dose level 4|Dose of PY159 as a single agent given in a standard 3+3 design.
15771589|NCT04682431|Drug|PY159 Single agent dose level 5|Dose of PY159 as a single agent given in a standard 3+3 design.
15771590|NCT04682431|Drug|PY159 Single agent dose level 6|Dose of PY159 as a single agent given in a standard 3+3 design.
15771591|NCT04682431|Drug|PY159 Single agent dose level 7|Dose of PY159 as a single agent given in a standard 3+3 design.
15771592|NCT04682431|Drug|PY159/Pembrolizumab Combination dose level 1|Dose of PY159 and given in combination with pembrolizumab
15771593|NCT04682431|Drug|PY159/Pembrolizumab Combination dose level 2|Dose of PY159 and given in combination with pembrolizumab
15771594|NCT04682431|Drug|PY159/Pembrolizumab Combination dose level 3|Dose of PY159 and given in combination with pembrolizumab
15771595|NCT04682431|Drug|PY159/Pembrolizumab Combination dose level 4|Dose of PY159 and given in combination with pembrolizumab
15771596|NCT04682431|Drug|PY159/Pembrolizumab Combination dose level 5|Dose of PY159 and given in combination with pembrolizumab
15771597|NCT04682431|Drug|PY159 Single agent dose expansion cohorts|Dose of PY159 as a single agent given for predefined tumor histology
15771598|NCT04682431|Drug|PY159/Pembrolizumab Combination dose expansion cohorts|Dose of PY159 as a single agent and in combination with pembrolizumab for predefined tumor histology
15771599|NCT04682418|Device|xvision Spine sytem|pedicle screw placement will be performed using the XVS navigation system
15771600|NCT04682405|Drug|Uproleselan|Provided by study
15771601|NCT04682405|Drug|Placebo|Provided by study
15771602|NCT04682405|Drug|Melphalan|-Standard of care
15771603|NCT04682392|Device|Delfi's PTS Personalized Tourniquet System for Blood Flow Restriction Group|A Delphi Personal Tourniquet system for blood flow restriction (BFR) therapy will be applied to each treatment session for this group. They will do 3-5 exercises with the BFR system on the surgical or both lower extremities for bilateral or unilateral movements.
15771604|NCT04682392|Other|Standard ACL rehab|Standard accelerated ACL protocol
15771605|NCT04682379|Diagnostic Test|Repositioning|"Trunk circumduction test
~Trunk flexion-hyperextension test
~Trunk lateral flexion test
~Trunk axial rotation test
~Finger-to-Nose test
~Fukuda stepping test"
15771606|NCT04682366|Drug|Tamsulosin|Oral drug: 10 days of 0.4 mg of oral Tamsulosin
15771607|NCT04682366|Drug|Placebo|Oral drug: 10 days of identical-appearing placebo
15771608|NCT04682353|Drug|TV-46046|SC injection of 300 mg/mL (120 mg/0.4mL; 180 mg/0.6mL; 240 mg/0.8mL)
15771609|NCT04682353|Drug|DeposubQ Provera|SC injection of 104 mg/0.65 mL
15771610|NCT04682340|Diagnostic Test|Serum BPA|Serum BPA levels will be compared between women with autoimmune thyroid disease and normal women.
15771611|NCT04682327|Other|Response to anti-PD-1/PD-L1|Response to anti-PD-1/PD-L1, after 4 cycles of anti-PD-1/PD-L1 treatment.
15771612|NCT04682327|Other|Non-response to anti-PD-1/PD-L1|Non response to anti-PD-1/PD-L1, after 4 cycles of anti-PD-1/PD-L1 treatment.
15771613|NCT04682301|Behavioral|Behavioral Intervention|Receive SDM intervention
15771614|NCT04682301|Other|Discussion (focus group)|Attend focus group
15771615|NCT04682301|Other|Discussion (feedback on SDM)|Provide feedback on SDM
15771616|NCT04682301|Other|Interview|Attend a telephone interview
15771617|NCT04682301|Other|Survey Administration|Ancillary studies
15771618|NCT04682288|Drug|Levofloxacin Ocular Implant|Levofloxacin Ocular Implant an implant that delivers a bolus dose of levofloxacin and a constant daily dose for a further 5-7 days.
15771619|NCT04682275|Other|Psychological measurements|A questionnaire test (Beck depression Inventory) for depression was performed.
15771651|NCT04682028|Other|professional care|The trained nurses provide professional care for the patients.
15771624|NCT04682223|Behavioral|Semantically-focused therapy tasks|1) Semantic feature analysis (SFA; Boyle & Coelho, 1995; Boyle, 2004). For each pictured stimulus the participant is prompted to name the picture. Then, s/he is encouraged to produce semantically related words that represent features similar to the target word. 2) Semantic barrier task. This approach includes features of the Promoting Aphasics' Communication Effectiveness (PACE; Davis & Wilcox,1985). The goal of the task is for one participant (e.g., person with aphasia) to describe each card so that the other participant (e.g., clinician) can guess the picture on the card. 3) Verb network strengthening therapy (VNeST; Edmonds et al., 2009; 2014) targets lexical retrieval of verbs and their thematic nouns. The objective of VNeST is for the participant to generate verb-noun associates with the purpose of strengthening the connections between the verb and its thematic roles.
15771625|NCT04682223|Behavioral|Phonologically-focused therapy tasks|1) Phonological components analysis task (PCA; Leonard et al., 2008). The participant first attempts to name a given picture and then to identify the phonological features of the target words. 2) Phonological production task focuses on the identification of phonological features of targeted, imageable nouns and verbs. It requires the participant to sort picture stimuli based on the number of syllables and then to identify a hierarchy of phonological features. Once each targeted feature is identified for the pair of words, the participant is required to blend the syllables/sounds together. 3) Phonological judgment task relies on computerized presentation of verbs and nouns where participants are required to judge whether pairs of words include similar phonological features (e.g. # of syllables, initial phonemes, final phonemes, rhyming).
15771626|NCT04682210|Drug|Sintilimab|Sintilimab 200mg IV Q3W
15771627|NCT04682210|Drug|Bevacizumab|Bevacizumab 7.5mg/kg IV Q3W
15771629|NCT04682184|Drug|Propranolol|Administered orally.
15771630|NCT04682184|Drug|Pseudoephedrine|Administered orally.
15771631|NCT04682184|Device|Wearable Biosensor Patch Device|Biosensor patch device attached to the chest and worn throughout the trial with replacement of biosensor every 7 days.
15771632|NCT04682171|Other|Low level laser therapy|"Gallium aluminium arsenide laser device will be used with wavelength of 850nm, power 100 mW, spot size of 1.0 mm and energy of 6J/point for 60seconds. Total 8 points will be irradiated. It will take 20 minutes.
~Patient will receive treatment in supine position with the affected knee(s) slightly flexed supported by the pillow or rolled towel.
~On the affected knee the laser probe will placed with full contact with skin at 8 points. Three points at medial side of the knee, three points at lateral side and two points at the medial edge of the bicep femoris muscle tendon and semitendinosus muscle tendon in the popliteal fossa"
15771633|NCT04682171|Other|Conventional Exercise Therapy|"Quadriceps isometric strengthening exercises.
~Range of motion and active stretching exercises applied to hamstring and quadriceps muscle.
~Hamstring muscle isometric exercises
~Active ankle pump.
~Short arc terminal extension exercises for the knee joint.
~Static and dynamic strengthening exercises for the hip abductors, adductors and extensor group of muscles.
~Non-weight bearing progressive resistance exercises with weighted cuffs, with progression to closed chain exercises as patient's pain allows.
~Isometric exercises were applied with 6 second contractions and rest period of 2 seconds. Isotonic exercises were started as 10 repetitions with half of weight of 10 RM, 10 repetitions with three fourth of this weight and 10 repetitions with whole 10 RM"
15771634|NCT04682158|Drug|Carboplatin|Given IV
15771635|NCT04682158|Radiation|3 Dimensional Conformal Radiation Therapy|Undergo 3D CRT
15771636|NCT04682158|Drug|Propranolol|Subject will be treated with 30 mg po BID Propranolol for up to 6 weeks
15771637|NCT04682158|Radiation|Intensity Modulated Radiation Therapy|Undergo IMRT
15771638|NCT04682158|Drug|Paclitaxel|Given IV
15771639|NCT04682145|Drug|Turoctocog alfa pegol|Patients will be treated with commercially available turoctocog alfa pegol according to routine clinical practice at the discretion of the treating physician. A decision to initiate treatment with commercially available turoctocog alfa pegol has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in the registry in scope.
15771640|NCT04682132|Diagnostic Test|COVID-19 antigen and antibody tests, and influenza rapid test|Study volunteers will be offered free COVID-19 and influenza testing and the opportunity to complete an electronic survey about any symptoms.
15771641|NCT04682119|Drug|LY3526318|Administered orally.
15771642|NCT04682119|Drug|Placebo|Administered orally.
15771643|NCT04682106|Drug|LY3493269|Administered orally.
15771644|NCT04682106|Drug|Placebo|Administered orally.
15771645|NCT04682080|Behavioral|Needle-free injection|"This study was performed among children aged 4-10 years who required dental treatment and were treated at the Department of Pedodontics, Faculty of Dentistry, Gaziosmanpasa University. A total of 120 patients were evaluated in accordance with the exclusion criteria and 94 children (39 girls and 55 boys) were included in this study. Children who needed dental treatment were randomly divided into two groups. All dental injections were administered by the same operator (MB), a pediatric dentist with two years of experience in using the Comfort-In system.
~In both groups, the children were asked to rate their pain intensity by choosing the closest statement on the colorful Wong-Baker Pain Scale at four time points: immediately after injection (Pain 1), during treatment (Pain 2), at the end of the treatment (Pain 3) and postoperative first day.Anxiety levels were recorded using the Modified Children's Dental Anxiety Scale face version"
15771646|NCT04682067|Behavioral|Contingency Management|Escalating financial incentives contingent upon biochemical evidence of abstinence
15771647|NCT04682067|Behavioral|Usual Care smoking cessation|Usual care smoking cessation support
15771648|NCT04682054|Procedure|ocular surgery|surgery to remove the pathological eye tissue
15771652|NCT04682028|Other|coventional care|nurses provide coventional care for the patients.
15771653|NCT04682015|Other|WeChat platform group|Participants in the intervention group will receive educational messages related to hypertension, such as impact of hypertension on cardiovascular system, lifestyle adjustment and side effects of antihypertensive drugs. Participants will be reminded to take their blood pressure regularly and enter the blood pressure readings into the WeChat platform. If participants enter extremely high or low readings, they will be asked to seek medical help from doctors. Participants can also consult doctors online via WeChat platform by text and voice messages, or voice calls.
15771654|NCT04682002|Other|Osteopathic manipulative treatment|"OMT will be used to treat pregnancy women after having performed a manual osteopathic assessment. The first osteopathic evaluation is carried out during the 12th week, with the possibility to undertake a personalized treatment built on the needs of the single patient; the chosen techniques are based on the collected data by the operator. A black-box type of treatment is undertaken."
15771655|NCT04682002|Other|Usual care|Administration of routine care based on international guidelines
15771656|NCT04682002|Other|Mindfulness|Mindfulness group weekly meetings. Mindfulness practices consist of cognitive and behavioral treatments for depression and anxiety, including mindfulness-based stress reduction and mindfulness-based cognitive therapy.
15771657|NCT04682002|Other|Yoga|Weekly yoga group meetings. Yoga is a mind-body practice that encompasses a system of postures, deep breathing, and meditation. In this context, yoga practice is adapted to pregnancy with the aim of benefit women who suffer from anxiety, depression, stress, low back pain, and sleep disturbances.
15771658|NCT04682002|Other|Clinical nutrition|Nutritional advice to all women participating in the study at 12 weeks of pregnancy, with the possibility of starting an individualized path.
15771659|NCT04682002|Other|Coaching|There will be five personalized coaching sessions during the pregnancy.
15771660|NCT04681989|Behavioral|Moving On After Breast Cancer|"After the MOVE-ABC interventional group participant completes their baseline assessment (T0) and been given the study survey by a research staff member she will receive the following:
~Instructions on how to use the physical therapy-based education materials by a research staff member
~a range of motion wand
~a small ball
~MOVE-ABC education booklet and video
~The intervention group will complete 4 weekly follow-ups with a research staff member over the phone. The follow-ups will be completed in between the T0 (baseline) assessment, and the T1 (1 month after baseline) assessment."
15771661|NCT04681976|Behavioral|Telematic dance program|"Telematic dance program
~The dance program will consist of 24 sessions distributed twice a week for a total period of 3 months. Each session will include:
~A) Warm up: It will consist of analytical and global movements of increasing intensity and stretching exercises. It will also involve body awareness and motor control exercises.
~B) Choreography part: the participants must follow and learn the choreographies. Intensity ranges shall vary between low and moderate. (3-4 in Borg's Modified Scale (0-10)).
~C) Cool down: It will consist of global movements of decreasing intensity, stretching, breathing, and relaxing exercises."
15771662|NCT04681963|Other|Clinical Assessment within 4 hours of admission|Demographics, Symptoms, Severity scores (Triage at admission, confusion, urea, respiration, blood pressure, age (CURB 65) and pneumonia severity score (PSI), clinical parameters, blood testing, chest x-rays, comorbidities, electro-cardiogram
15771663|NCT04681937|Combination Product|Subacromial Injection (hyaluronic acid) + Physical Therapy.|arm1: sodium hyaluronate (4ml) arm2: platelet-rich-plasma (4ml) arm3: methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) arm4: serum saline (4ml) The same physical therapy procedure will be applied to all arms after injection.
15771664|NCT04681937|Combination Product|Subacromial Injection (Platelet-Rich-Plasma) + Physical Therapy.|arm1: sodium hyaluronate (4ml) arm2: platelet-rich-plasma (4ml) arm3: methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) arm4: serum saline (4ml) The same physical therapy procedure will be applied to all arms after injection.
15771665|NCT04681937|Combination Product|Subacromial Injection (methylprednisolone acetate) + Physical Therapy.|arm1: sodium hyaluronate (4ml) arm2: platelet-rich-plasma (4ml) arm3: methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) arm4: serum saline (4ml) The same physical therapy procedure will be applied to all arms after injection.
15771666|NCT04681937|Combination Product|Subacromial Injection (Serum Saline) + Physical Therapy.|arm1: sodium hyaluronate (4ml) arm2: platelet-rich-plasma (4ml) arm3: methylprednisolone acetate (1ml methylprednisolone acetate + 3 ml serum saline) arm4: serum saline (4ml) The same physical therapy procedure will be applied to all arms after injection.
15771667|NCT04681924|Other|Diet intervention|Low carb diet group are compared to low fat diet group and followed up for 6 months
15771668|NCT04681911|Drug|Inetetamab|Inetetamab: 8mg/kg for the first dose, 6mg/kg for the following doses, every 3 weeks for one cycle.
15771669|NCT04681911|Drug|Pyrotinib|Pyrotinib: 400mg, oral, every day.
15771670|NCT04681911|Drug|Capecitabine|Capecitabine, 1000 mg/m2, d1-d14, 3-week cycle
15771671|NCT04681911|Drug|Gemcitabine|Gemcitabine, 1000 mg/m2, D1, D8, 3-week cycle
15771672|NCT04681911|Drug|Vinorelbine|Vinorelbine, 25-30 mg/m2, D1, D8, 3-week cycle
15771673|NCT04681911|Drug|Carboplatin|Carboplatin, AUC = 6, 3-week cycle
15771674|NCT04681911|Drug|Albumin paclitaxel|Albumin paclitaxel, 100 mg/m2, weekly
15771675|NCT04681911|Drug|Eribulin|Eribulin, 1.4 mg/m2, D1, D8, 3-week cycle
15771676|NCT04681885|Device|Tapered bristles A|Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week .
15771677|NCT04681885|Device|Tapered bristles B|Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.
15771678|NCT04681885|Device|End rounded bristles|Subjects use the toothbrush two times daily with a fluoride toothpaste for 2 minutes with instructed brushing method for one week.
15771679|NCT04681872|Procedure|Destruction of Marshall bundles|Destruction of Marshall bundles by ethanol 96% infusion (2 separate injections of 5ml on 1 minute each) followed by ablation of the distal coronary sinus bundles, the ridge and the saddle.
15771680|NCT04681872|Procedure|Pulmonary veins isolation|Achievement of a wide disconnection of the right and left pulmonary veins.
15771681|NCT04681872|Procedure|Linear ablation in the left and right atria|Ablation of the mitral, the roof, and the cavo-tricuspid isthmus
15771732|NCT04681430|Biological|Convalescent plasma|transfusion of convalescent plasma (CP) with neutralizing antibodies against anti-SARS-CoV-2 ((titer of at least 1:160)
15771682|NCT04681859|Device|High Flow Nasal Oxygen (HFNO) treatment|Administration of High Flow Nasal Oxygen (HFNO) to patients who did not respond to standard low-flow oxygen therapy (non-rebreather mask on 15L/min). Adjust flow-rate and FiO2 as per standard HFNO treatment protocol.
15771683|NCT04681859|Device|Continuous Positive Airway Pressure (CPAP) therapy using OxyJet|Administer CPAP to patients who did not respond to standard low-flow oxygen therapy (non-rebreather mask on 15L/min). CPAP initiated with FiO2 at 40% and a 10cm PEEP. Titrate PEEP to 15 cm if required. Deliver additional oxygen via secondary port if a higher FiO2 is required.
15771684|NCT04681846|Procedure|Staged approach using antibiotic-cement impregnated PMMA spacer|It will be prepared in the following manner. the cement will be mixed with vancomycin in a ratio of 2 gm to each 40 gm of the spacer. The spacer should be shaped into a cylinder before its solidification. The spacer should be as big as possible to fill the whole defect, without compromising the soft tissue and skin closure. Also, cement should wrap the two ends of bone extremities on 2 or 3 centimeters.
15771685|NCT04681833|Drug|Recombinant Respiratory Syncytial Virus Vaccine (BARS13) /placebo|Low Repeat Dose
15771686|NCT04681833|Drug|Recombinant Respiratory Syncytial Virus Vaccine (BARS13)|High Repeat Dose/High Repeat Multiple Dose
15771687|NCT04681833|Drug|Placebo|Liquid diluent/Lyophilised Powder
15771688|NCT04681820|Drug|Flumatinib|Flumatinib mesylate tablets 600mg qd for 24 months
15771689|NCT04681820|Drug|Nilotinib|Nilotinib Capsules 400mg bid for 24 months
15771690|NCT04681807|Behavioral|Emotion Recognition Training|Participants will undergo 2 fMRI scans, one before and one after the training sessions. There will be 4 visits consisting of an emotion recognition training exercise on iPad, lasting for a period of ~1 hour each. (More details about each condition will be added after study completion to protect the blinding of participants) .
15771691|NCT04681807|Behavioral|Active Control Training|Participants will undergo 2 fMRI scans, one before and one after the training sessions. There will be 4 visits consisting of a control training exercise on iPad, lasting for a period of ~1 hour each. (More details about each condition will be added after study completion to protect the blinding of participants) .
15771692|NCT04681794|Other|exercise-based intervention|MayoP4 is a 15-minute warmup with 4 different components of exercise: balance, posture, jumping/hopping, and movement-based mindfulness.
15771693|NCT04681768|Drug|Abemaciclib|Abemaciclib tablets 150 mg, 100 mg, 50 mg as clinical routine: 150 mg twice daily per os, in-label administration in combination with endocrine therapy (aromatase inhibitor or Fulvestrant)
15771694|NCT04681742|Behavioral|CO-OP Group|CO-OP focuses on learning of a global problem-solving strategy, Goal-Plan-Do-Check (GPDC), within the performance of participant-chosen goals. Use of a broadly applicable strategy and meaningful activity ensures the intervention is salient to the participant and increases likelihood of transfer. Uniquely, therapists applying CO-OP use guided discovery methods, such as asking a series of probing questions, to support participants in analyzing their own performance of a given task and generating potential solutions for improving performance. Participants become equipped with these skills through repetitive application of the GPDC process. First, participants identify a specific goal (Goal). Then, participants consider a detailed plan (Plan) for accomplishing the goal. By carrying out the plan (Do) and critically analyzing the results (Check), participants determine how the plan worked. The intervention focuses on learning GPDC with gradual withdrawal of guided discovery methods.
15771695|NCT04681729|Drug|Dupilumab SAR231893|Pharmaceutical form:Injection solution Route of administration: Subcutaneous
15771696|NCT04681729|Drug|Placebo|Pharmaceutical form:Injection solution Route of administration: Subcutaneous
15771697|NCT04681729|Drug|Non sedating H1-antihistamine|Pharmaceutical form:Tablet Route of administration: Oral
15771698|NCT04681716|Other|ELDOA|For Spinal Segment L4-L5 and L5-S1 proper ELDOA position was instructed to the experiment group patients.ELDOA stands for Elongation Longitudinaux Avec Decoaption Osteo Articulaire, or LOADS (Longitudinal Osteo-articular De-coaptation Stretching). ... They can be described as fascial stretch that localizes tension at the level of a specific spinal segmental.
15771699|NCT04681716|Other|CONVENTIONAL PHYSIOTHERAPY|"Transcutaneous Electrical Nerve Stimulation (TENS):
~120Z dual channel TENS unit made in Japan was used in the research. Electrodes of TENS were placed on lumbar region and TENS was given for 15 minutes on Constant mode. Intensity was adjusted according to patient's comfort.
~Hot pack was applied on the lumbar region for 10 - 15 minutes.Lumbar Mobilization (CPA) was given on spinous process of L1- L5 vertebrae and L5-S1. For every session given 3 sets of 10 repetitions of each lumbar vertebra was performed."
15771700|NCT04681703|Behavioral|Nurse-led program on accuracy of blood pressure self-measurement|The training program was performed in accordance with current guidelines and consisted of a 1-h educational session led by one family nurse (FN) tasked with instruction of the patients. During the training program the FN emphasized that since morning and evening blood pressure (BP) values can widely differ, especially in patients taking medications, BP should be measured twice a day, in the morning and at evening, at specific fixed times (between 6:00 am and 9:00 am and between 6:00 pm and 9:00 pm) at least during the first week of monitoring. Thereafter, measurements can be taken before antihypertensive drugs are taken.
15771701|NCT04681690|Other|No intervention, observation only.|Observation only
15771702|NCT04681677|Radiation|Radiation: Intra-operative Radiation Therapy - IORT|Single fraction, Intra-operative Radiation Therapy at the time of surgical resection of recurrent GBM followed by Bevacizumab 28-56 days after surgery.
15771703|NCT04681677|Drug|Bevacizumab|Bevacizumab
15771704|NCT04681677|Drug|Avastin|Avastin
15771705|NCT04681664|Other|High fat diet|50 % fat
15771706|NCT04681651|Drug|Normobaric Hyperoxia|Within 6 hours after stroke onset, patients were randomized into the NBO group and immediately given 100% oxygen inhalation (no more than 30 minutes after admission) at a ventilation rate of 10L/ min using a sealed non-ventilating oxygen storage mask and keep giving oxygen for 4 hours. If the patient needs to be intubated with a ventilator to maintain ventilation, the FiO2 should be set to 1.0.
15771707|NCT04681651|Drug|Sham Normobaric Hyperoxia|For Sham NBO group, Patients were immediately given oxygen inhalation (no more than 30 minutes after admission) at a ventilation rate of 1l/min using the same mask and keep giving oxygen for 4 hours. If the patient needs to be intubated with a ventilator to maintain, the FiO2 should be set to 0.3 and gradualy incerased if spO2≤94%；
15771708|NCT04681651|Procedure|Endovascular Thrombectomy|ET is the international guidelines for the treatment of acute ischemic stroke with lage vessel occlusion.
15771709|NCT04681638|Drug|Pathogen-Reduced Plasma|The treatment group will receive an additional infusion of Pathogen-Reduced Plasma based on the formula, hourly rate, mL/hr = (1 mL*kg*TBSA)/24 hr. This infusion will not be titrated. It will be discontinued at the end of the 24th postburn hour.
15771710|NCT04681638|Drug|Crystalloid Solutions|The control group will receive an additional infusion of LR based on the formula: hourly rate, mL/hr = (1mL*kg*TBSA)/24 hr. this infusion will not be titrated. It will be discontinued at the end of the 24th postburn hour.
15771711|NCT04681625|Behavioral|Pelvic floor muscle training (PFMT) with suppressive urgency technique|"Pelvic floor muscle training with suppressive urgency technique:
~Education about proper urination training in the period without pathological urgency.
~Education about conscious urgency suppression through PFMT - suppressive urgency technique.
~Education on the principle and effect of PFMT.
~Exercises of varying intensity of pelvic floor muscles in different positions.
~Exercises to relax the pelvic floor muscles. Exercise 5 times a week for 20-30 minutes a day."
15771712|NCT04681612|Diagnostic Test|MSNA|"Assessed via Muscle Microneurography during the first 14 days of the acute phase.
~Indices: busts/min, busts/100bpm"
15771713|NCT04681612|Diagnostic Test|Heart Rate Variability|Assessed via 24hr ECG monitoring during the first 14 days of the acute phase. Indices: Time-domain, Frequency-domain, Non-linear
15771714|NCT04681612|Diagnostic Test|Blood Pressure Variability|Assessed via Ambulatory BPM during the first 14 days of the acute phase. Indices: SD, wSD, ARV, CV
15771715|NCT04681612|Diagnostic Test|CMR|Cardiac Magnetic Resonance during the first 14 days of the acute phase. Assessment of oedema, Late Gadolinium Enhancement ischaemic pattern. Assessment of cardiac function parameters
15771716|NCT04681612|Diagnostic Test|History, Lab, clinical and hemodynamic parameters|1. Description of event, 2. Risk factors, 3. Medical history, 4. ECG parameters, 5. ECHO parameters, 6. Hemodynamic parameters of acute phase and hospitalization, 7. Coronary angiogram paraemeters, 7. Complete lab parameter assessment, 8. Thrombofilia assessment, 9. SF-12 QoL and Anxiety and Depression Scale (HADS) questionnaires
15771717|NCT04681599|Device|Filter|Filter is used to capture any individual bacteria or viruses that might be suspended within inhaled or exhaled gases
15771718|NCT04681599|Device|Scavenger face tent|A face tent is connected to a vacuum resource to continuously suction the exhaled gas from the subject, in order to reduce the transmission risk of virus or bacteria
15771719|NCT04681586|Device|bright light therapy|using a bright light therapy device (10.000 lux) for 30min every morning for two weeks
15771720|NCT04681586|Device|dim red light|using the same device as the active group, but with an installed filter that dims light to <300 lux for 30min every morning for two weeks
15771721|NCT04681573|Diagnostic Test|blood tests|"Single arm : all NAFLD patients evaluating the FIB4-FS and the eLIFT-FMVCTE with two patient groups considered at inclusion:
~Low-risk group (neither metabolic syndrome nor AST ≥35 UI/l): Liver biopsy won't be mandatory in this group because of the very low risk of advanced fibrosis (4%). These patients will be considered as having no-mild F0-2 liver fibrosis and the study visit will be scheduled for clinical data recording, blood sampling, and LSM with Fibroscan. Liver biopsy could still be performed in the low-risk group if the investigator deems it is required for the clinical management of the patient.
~At-risk group (presence of a metabolic syndrome and/or AST ≥35 UI/l): Because of the increased prevalence of significant liver lesions in this group, the patients will have a liver biopsy with clinical data recording, blood sampling, and Fibroscan the same day."
15771722|NCT04681547|Procedure|Genicular nerve Block|"After the administration of spinal anesthesia, the anatomical structures of the proximal and distal region of the knee will be explored through an M- ultrasound machine Turbo® with a high-frequency 6-13 MHz linear probe.
~The ultrasound transducer will be placed in a coronal orientation to the axis of the knee in the corresponding area to be blocked according to anatomical landmarks of superior medial genicular nerve (SMGN), inferior medial genicular nerve block (IMGN), superior lateral genicular nerve (SLGN), inferior lateral genicular nerve (ILGN), and recurrent genicular nerve (RGN).
~It should be noted that the visualization of the genicular arteries in the femoral epicondyles and in the area of the tibial plateau, represents an accurate guide to where the sensory afferents are, however; its display is not constant.
~4 ml of 0.2% ropivacaine will be administered, with adrenaline 1: 100 000 in each of the five nerves."
15771723|NCT04681547|Procedure|Local Infiltration Analgesia|100 ml of ropivacaine 0.2% with 1 mg of epinephrine during the period of intraoperative ischemia and, before the closure of the surgical wound, 50 ml of ropivacaine 0.2%.
15771724|NCT04681534|Device|AlphaDBS System|AlphaDBS can be programmed with two different types of stimulation: conventional DBS and adaptive DBS, that automatically adjusts the energy delivered to patient using a biosignal, local field potential (LFP), in a close loop configuration.
15771725|NCT04681521|Other|Hot and Cold compress, nursing interventions|using thermal compress at 38-39 °C (hot) and 15-16 °C (cold) on the distal regions of both lower extremities of the patients
15771726|NCT04681508|Diagnostic Test|Chest CT without contrast enhancement and chest X-ray|Chest CT without contrast enhancement and chest X-ray as supplement to diagnostic abdominal CT
15771727|NCT04681495|Behavioral|STAC|STAC is a brief, stand-alone bullying bystander intervention for middle school students, to reduce bullying and mental health risks for bystanders. The primary outcome will be showing usability for the technology-based program (STAC-T) prototype.
15771728|NCT04681482|Drug|Apixaban|Anticoagulant medication used to treat and prevent blood clots and to prevent stroke in people with nonvalvular atrial fibrillation.
15771729|NCT04681469|Drug|Niraparib|"For all patient's population:
~Niraparib 200 mg/day: day -49 to day -21;
~Dostarlimab 500 mg iv: day -49 and day -28; At day -21, clinical evaluation will be performed and the patient will be directed to surgery with exclusion from the study in case of progressive disease. Radiological assessment will be performed according to the physician's judgement.
~If no clinical evidence of disease progression:
~Niraparib 200 mg/day: day -21 to day -7
~Dostarlimab 500 mg iv: day -7
~Radiological assessment (day -1, ± 3 days),
~Surgery (original margin) at day 0 (±3 days)
~Standard postoperative (chemo)radiotherapy according to pathologic report;
~Maintenance Niraparib, 200 mg/day for 6 months
~Maintenance Dostarlimab, 500 mg iv q3W for the first four cycles and 1000 mg iv Q6W thereafter for 3 months."
15771730|NCT04681456|Behavioral|There is no medical intervention for the purposes of this Registry.|There is no medical intervention for the purposes of this Registry.
15771731|NCT04681443|Drug|Crystallized phenol application|Crystallized phenol application into the sinus tract
15837766|NCT04142762|Drug|Midazolam|Midazolam syrup
15771736|NCT04681417|Drug|Melphalan or Melphalan + Topotecan|IAC: 2-6 cycles every 1 month (number based on the local tumor evolution), performed using radio-guided catheterization and delivery at the ostium of the ophthalmic artery, in neuroradiology operating room, and under General Anesthesia (GA). IAC will be administered at the Fondation Rothschild Hospital in collaboration with the Interventional Neuroradiology team.
15771737|NCT04681417|Drug|etoposide, carboplatin and vincristine|2 to 6 cycles of combined etoposide, carboplatin and vincristine
15771738|NCT04681417|Drug|Carboplatin administered on Day 1|Chemothermotherapy : Intravenous injection by carboplatin
15771739|NCT04681417|Device|Thermotherapy (local treatment)|Thermotherapy after carboplatin administered on Day 1
15771740|NCT04681417|Device|Cryotherapy (local treatment)|Cryotherapy (local treatment)
15771741|NCT04681417|Device|Iodine-125 plaques (local treatment)|Iodine-125 plaques (local treatment)
15771742|NCT04681417|Drug|Intravitreal Melphalan chemotherapy injections (local treatment)|Intravitreal Melphalan chemotherapy injections (local treatment)
15771743|NCT04681404|Procedure|Knee Arthroplasty|Comparison of TKA, UKA and healthy controls in relation to balance, function and QOL
15771744|NCT04681391|Device|transCranial direct current stimulation|In the present study, we applied DC Brain Stimulator Plus to stimulate right temporoparietal junction (rTPJ). The target electrode was placed over the location of rTPJ; on the other hand, the return electrode was placed over the left supraorbital area. That is, during anodal tDCS, the anode was placed over CP6, and the cathode was placed over left supraorbital area; conversely, during cathodal tDCS, the cathode was placed over CP6, and the anode was placed over left supraorbital area. For the active stimulation, which are anodal and cathodal tDCS, a constant current of 1 mA was delivered through 35 cm2 electrode for 20 minutes with fade-in and fade-out of 10 seconds, producing a current density of 0.029 mA/cm2. On the other hand, same fade-in, fade-out, and current density were applied for the sham stimulation, but the duration of current-delivering only last 35 seconds. Therefore, participants could feel the skin sensation but did not have the after-effects of tDCS.
15771745|NCT04681378|Procedure|double layer step up-step down technique|the incision is closed using Vicryl 1-0 stitch starting from one corner. The first layer is transversely passed through the inner myometrium-decidua line, and second layer is transversely passed through outer myometrium-visceral line continuously by alternating continuous stitches through the upper (step up) and the lower (step down) uterine flaps. The original string is returned to the starting point and tied with knot as in Turan technique. Following the double layered step up-step down closure, additional single sutures were added for hemostasis if required
15771746|NCT04681365|Other|Staff will wear and evaluate Bubble-PAPR (non-CE marked PAPR)|Staff will wear and evaluate the Bubble PAPR instead of usual PPE consisting of FFP3/N95 facemasks. This novel, non-CE marked prototype PPE is a Powered air Purifying Respirator and is used 'in house' (not approved for use outside of the Sponsor organisation)
15771747|NCT04681339|Other|Antibiotic treatment|Antibiotic treatment
15771748|NCT04681339|Other|No antibiotic treatment|No antibiotic treatment
15771749|NCT04681326|Device|biological prosthesis|retro-muscular positioning of a swine dermal collagen prosthesis
15771750|NCT04681313|Procedure|High-risk percutaneous coronary intervention|Percutaneous coronary interventions (PCI) deemed high risk based on patient-related risk features, hemodynamic criteria, clinical presentation and complexity of coronary anatomy.
15771751|NCT04681300|Other|Skin biopsy|a skin sample will be taken using a 4 mm punch biopsy in lesional skin
15771752|NCT04681300|Other|Plastic surgery remnants|healthy skin from plastic surgery interventions
15771753|NCT04681287|Drug|inetetamab and PD-1 inhibitor combined with chemotherapy.|"Chemotherapy selected by doctors: albumin bound paclitaxel, vinorelbine, gemcitabine, capecitabine, and aribrin were administered according to clinical routine;
~The first dose was 8 mg / kg, followed by 6 mg / kg, once every 3 weeks
~PD-1 inhibitor 200mg D1 every 3 weeks as a cycle Treatment to disease progression or toxicity intolerance, or death from any cause.
~The efficacy was evaluated every 2 cycles and adverse events were recorded. After 4-6 cycles of treatment, if the patient is intolerable to chemotherapy for any reason, the chemotherapy can be stopped and the combination of inistumab and PD-1 can be continued."
15771754|NCT04681274|Device|Image features extraction and clustering|"The image processing operations required for local content-based image feature extraction consist of two main tasks: 1) tiling the images in smaller VOIs, typically a small cube, whose size depends on the modality, on the image resolution and on the purpose of the content-based query, and 2) performing feature extraction operations on the VOIs.
~The Feature Extraction Engine performs totally unsupervised, automatic and asynchronous extractions of features from the images, organizes and indexes them in a no-SQL database based on unique similarity metric. The results of this phase are a series of clusters of phenotype signatures."
15771755|NCT04681274|Device|Phenotype signature database building|Since the clusters are self-organizing their pathophysiological meaning is not readily apparent and requires further analysis. The characterization of each cluster is performed by analyzing representative samples and their respective correlation with histopathology results. After a series of iterations, the clusters are organized to correlate with distinct tissue subtypes identified by their signature similarity. The final number of clusters is not known a priori and depends on the heterogeneity of the underlying imaging phenotypes.
15771756|NCT04681261|Other|this study is not an intervention study|this study is not an intervention study
15771757|NCT04681248|Drug|DKN-01|Administered by IV infusion
15771758|NCT04681235|Other|Training on VR|The training is aimed at improving the functioning of the motor sphere, including balance, gait, and upper limb function, as well as increasing the level of motivation and reducing the level of anxiety and depression. Game applications were selected based on therapeutic tasks of motor recovery.
15771759|NCT04681222|Procedure|LFCN|LFCN block was performed in combination with PENG block
15771760|NCT04681222|Procedure|Wound infiltration|Wound infiltration was performed in combination with PENG block
15771761|NCT04681209|Behavioral|DRT Condition|"Children were asked to provide five descriptors of two children who each engaged in defending behaviors. Two weeks later they were told the top seven descriptors given by the hundreds of children participating in the project. This was followed by a brief discussion of how one could best help another kid who was getting bullied. Children then made posters to share with younger grades as to what friendship heroes are like, using the descriptor words shared with them, and how to be a friendship hero (i.e., how to help someone who is being bullied). Posters were hung for two-to-four months after the intervention activity."
15771762|NCT04681209|Behavioral|Empathy Condition|Children in the empathy-based condition were asked to provide five descriptors of how two children who were bullied would fee. Two weeks later they were told the top seven descriptors given by the hundreds of children participating in the project. This was followed by a brief discussion of how one could best help another kid who was getting bullied. Children then made posters to share with younger grades as to what being bullied feels like, using the descriptor words shared with them, and how to be a friendship hero (i.e., how to help someone who is being bullied). Posters were hung for two-to-four months after the intervention activity.
15771763|NCT04681196|Other|patients shifted to nasal mask after persistent OSA with oronasal mask|In this group were selected OSA patients exhibiting persistent obstructive events and paradoxical obstruction with oronasal masks during CPAP , that were fully recovered (no more OSA detected) with the shift to nasal one
15771764|NCT04681170|Drug|Lomitapide|2mg,5mg, 10mg and 20mg capsules
15771766|NCT04681131|Biological|CAB-AXL-ADC|Conditionally active biologic anti-AXL antibody drug conjugate
15771767|NCT04681131|Biological|PD-1 inhibitor|PD-1 inhibitor
15771768|NCT04681118|Biological|NurOwn (MSC-NTF cells)|Intrathecal administration
15771769|NCT04681105|Drug|Acetaminophen|Given PO
15771770|NCT04681105|Drug|Dexamethasone|Given IV
15771771|NCT04681105|Drug|Diphenhydramine|Given IV or PO
15771772|NCT04681105|Biological|Flotetuzumab|Given IV
15771773|NCT04681105|Drug|Ibuprofen|Given PO
15771774|NCT04681105|Drug|Ranitidine|Given IV
15771775|NCT04681092|Biological|AKS-452|s.c. or i.m. vaccination
15771776|NCT04681079|Drug|albuterol sulfate (MDI)|albuterol sulfate inhalation aerosol delivered via metered-dose inhaler (MDI) with spacer
15771777|NCT04681079|Drug|albuterol sulfate (nebulizer)|albuterol sulfate inhalation aerosol delivered via nebulizer with filtered mouthpiece
15771780|NCT04681053|Drug|Ivermectin Powder|- Administration through inhalation (6mg) BID for 3 days
15771781|NCT04681027|Drug|Oxymorphone hydrochloride (HCl)|Opioid
15771782|NCT04681001|Device|nasal spray|application of nasal spray into nostrils and mouth
15771783|NCT04680988|Drug|SHR-1210|SHR-1210 intravenously every 3 weeks
15771784|NCT04680988|Drug|SHR-1020|SHR-1020 Orally once daily
15771785|NCT04680988|Drug|Physician's choice chemotherapy|Investigators will declare one of the following regimens:Albumin-bound paclitaxel injection, Pemetrexed disodium for injection, Gemcitabine for injection
15771786|NCT04680975|Drug|Belumosudil|12 to 15 subjects with dcSSc will receive belumosudil 200 mg PO BID for 52 weeks
15771787|NCT04680962|Biological|MabionCD20 (candidate biosimilar to rituximab)|Intravenous infusion, 10 mg/ml concentrate, 500 ml
15771788|NCT04680962|Biological|MabThera®|Intravenous infusion, 10 mg/ml concentrate, 500 ml
15771789|NCT04680962|Biological|Rituxan®|Intravenous infusion, 10 mg/ml concentrate, 500 ml
15771790|NCT04680949|Drug|Anakinra|Standard-of-care and anakinra. Anakinra is injected subcutaneously as 100 mg once daily for 10 days
15771791|NCT04680949|Drug|Placebo|Standard-of-care and placebo. Placebo is injected subcutaneously once daily for 10 days
15771792|NCT04680936|Drug|Dextrose 5% in water|low dose dextrose solution
15771793|NCT04680936|Drug|Dextrose 15 % in Water|high dose dextrose solution
15771794|NCT04680936|Drug|Isotonic sodium chloride solution|isotonic saline solution
15771795|NCT04680923|Procedure|CPPLAI|In this intervention, after general anesthesia patients will receive intraoperative combined periportal and preperitoneal bupivacaine 0.25% 2-3 mg/kg diluted in 40 ml normal saline.
15771796|NCT04680923|Other|Placebo|In this intervention, after general anesthesia patients will receive intraoperative combined periportal and preperitoneal 40 ml of sterile water.
15771797|NCT04680923|Drug|Bupivacaine 0.25%|In this intervention, after general anesthesia patients will receive intraoperative combined periportal and preperitoneal bupivacaine 0.25% 2-3 mg/kg diluted in 40 ml normal saline.
15771801|NCT04680897|Behavioral|Early restriction release|Participants will no longer have restrictions on vaginal penetration 2 weeks after surgery.
15771802|NCT04680897|Behavioral|Standard restriction recommendation|Participants will return to intercourse after 6 weeks
15771803|NCT04680884|Drug|Experimental for steroid|2 mg/kg/day of IV methylprednisolone for three days. As of day 4, the daily dose will be tapered to 1 mg/kg/day until day 7, followed by 0,5 mg/kg/day from day 8 to day 14 + IV placebo of isavuconazole
15771805|NCT04680884|Drug|Experimental for steroids and antifungals|IV methylprednisolone 2 mg/kg/day for three days. As of day 4, the daily dose will be tapered to 1 mg/kg/day until day 7, followed by 0.5 mg/kg/day from day 8 to day 14 + IV isavuconazole 200 mg every 8 hours for 2 days followed by 200 mg per day until ICU discharge or for a total duration of 14 days)
15771806|NCT04680884|Other|Standard of care|IV placebo of methylprednisolone + IV placebo of isavuconazole. This group receives the treatment that is currently recommended.
15771807|NCT04680871|Device|In-Ear Temperature Sensor|The device will passively monitor participants' temperature
15771808|NCT04680858|Other|DECT|Use of a digital enhanced telecommunication headset for team communication
15771809|NCT04680845|Behavioral|Self-affirmation|According to self-affirmation theory (Steele, 1988), defensiveness arises because people are motivated to defend their global sense of self-worth, which in the present case is threatened by perceptions of hearing aids/loss. However, if a person's self-image can be bolstered (affirmed) in a domain that is important to them, thereby preserving self-integrity, the individual should be less likely to process the threatening (i.e., stigmatizing in the present context) information defensively (Steele, 1988).
15771810|NCT04680832|Diagnostic Test|Electronic nose|First, patients will be asked to rinse their mouth thoroughly with water three times. Subsequently, exhaled breath analysis will be performed in duplicate with a 1-minute interval. An eNose measurement consists of five tidal breaths, followed by an inspiratory capacity maneuver to total lung capacity, a five second breath hold, and subsequently a slow expiration (flow <0.4L/s) to residual volume. The measurements are non-invasive and will cost approximately 5-10 minutes in total, including explanation and informed consent procedure. There are no risks associated with this study and the burden for patients is minimal.
15771811|NCT04680819|Dietary Supplement|Anatolian Propolis|Health workers who agree to participate in the study will be accepted as the study group, and healthcare professionals who do not agree to participate in the study will be considered as the control group. The study group will be asked to take 20 drops of Propolis drop form twice a day in the morning / evening, and the control group will not receive any treatment and both groups will be followed. In this process, patients diagnosed with COVID-19 will be determined. PCR test positivity taken from the throat for the diagnosis of COVID-19 will be accepted. The research will cover a period of 1 month. At the end of 1 month, patients diagnosed with COVID-19 in the study and control groups will be compared. Thus, the protective properties of Anatolian propolis will be determined.
15771812|NCT04680806|Device|Er,Cr:YSGG laser 2780 nm|The depigmentation procedure essentially involves laser ablation of epithelial layer of buccal gingiva containing melanin pigmentation.
15771813|NCT04680806|Device|Diode laser 940 nm|The depigmentation procedure essentially involves laser ablation of epithelial layer of buccal gingiva containing melanin pigmentation.
15771814|NCT04680793|Other|Rehabilitation|The program takes place over a total period of 9 weeks: for 4 weeks they will be cared for two days a week, then after a week's break, for 4 weeks they will be cared for three days a week for a total of approximately 80 hours of care. The program is multidisciplinary and includes: balneotherapy, ergometry, occupational therapy, gymnastics, physiotherapy, walking, sophrology, yoga as well as different workshops for the therapeutic education of the patient led by several professionals (dieticians, physiotherapists, doctors, psychologists).
15771815|NCT04680780|Other|Ketogenic diet|Patients will follow a classical ketogenic diet for 3 months
15771816|NCT04680780|Other|3-days water-fasting|Patients will perform water fasting on 3 consecutive days within the first 14 days of each of the 3 months. In one of the 3 months they are - if required - allowed to split the 3 days into periods of 1 and 2 days. On all other days of the intervention period they are allowed to eat ad libitum.
15771817|NCT04680780|Other|Control|Patients are allowed to eat ad libitum, but will be advised that low salt intake (< 5-7 g/day) and sufficient fluid intake (>3 l/day) which is considered beneficial in ADPKD.
15771818|NCT04680767|Drug|LY3502970|Administered orally.
15771819|NCT04680767|Drug|[¹⁴C]-LY3502970|Administered orally.
15771820|NCT04680754|Other|head-neck stretching exercises|Neck stretching exercises which include basic movements of the neck are simple and effective exercises. Stretching exercises provide neuromuscular coordination and flexibility in patients by reducing pain and muscle weakness (Nakamura, Kodama, and Mukaino 2014). For this reason, neck stretching exercises should be performed in early postoperative period and a nurse should teach the patient the head-neck stretching exercises and ensure the patient's comfort after thyroidectomy.
15771821|NCT04680741|Behavioral|Addiction Pilot App behavior tracking|a smartphone-based application (app) which is designed to monitor attendance at twelve-step facilitation meetings.
15771822|NCT04680728|Other|collection of biological parameters|haemoglobin, haematocrit, sodium, chloraemia, total protein, albumin, L-lactate, pro-BNP, creatinine, uremia, AST, ALT, GGT, ALP, bilirubin, prothrombin time, urinary test if available.
15771823|NCT04680728|Other|collection of echographic parameters|echocardiography (FEVG, subaortic ITV before and after LJP, cardiac index, MAPSE, mitral flow doppler, RVFAC, FEVD, STDVD, VD/VG ratio, TAPSE, tricuspid S wave, IT with PAPs, tricuspid flow doppler), Doppler of suprahepatic veins (S wave, D wave, S/D ratio), renal doppler (VII, RRI, aspect of venous flow in cortical and hilar), femoral venous doppler, doppler of the portal trunk, diameter of the VCI.
15771824|NCT04680728|Other|collection of clinical parameters|eason for hospitalisation, co-morbidities, IGS2 score, SOFA, haemodynamic signs (BP, HR, CVP), sinus rhythm or not, temperature, diuresis, weight, input-output assessment, use of dialysis, ventilatory parameters (intubation, mode, FiO2(%), Vt, FR, PEEP, plateau pressure, driving pressure), state of shock (sepsis, postoperative, haemorrhagic, cardiogenic), transfusion (type, number), catecholamines (type, dose, duration), diuretics and dose, clinical criteria of venous congestion (jugular turgidity, hepato-jugular reflux, hepatosplenomegaly, pitting oedemas of the lower limbs, hepatalgia), neurological evaluation (Glasgow Coma Scale, CAM-ICU), time to resume enteral feeding and bowel movements, weight.
15771825|NCT04680715|Radiation|Per-Operative Radiotherapy technique by Papillon +TM|20Gy Per-Operative Radiotherapy technique by Papillon +TM, on localized breast cancer
15771826|NCT04680702|Diagnostic Test|Sims Score|Evaluation Of siMS Score As Amarker Of Metabolic Syndrome In Children With Simple Obesity
15771827|NCT04680689|Diagnostic Test|128 Multislice CT coronary angiography|128 Multislice CT coronary angiography with the evaluation of coronary stenosis, the plaque vulnerability markers ( necrotic core, low attenuation plaque, spotty calcifications, napkin ring sign, positive remodeling), asses polar maps of the myocardium
15771828|NCT04680689|Diagnostic Test|2D Cardiac Transthoracic Echocardiography|2D Cardiac Transthoracic Echocardiography with the evaluation of the cardiac cavity dimensions
15771829|NCT04680689|Diagnostic Test|Laboratory Blood tests|Laboratory tests for evaluations the level of inflammatory biomarkers ( hs-CRP, MMP, IL6 and NT-pro-BNP), complete blood count, biochemestry
15771830|NCT04680676|Drug|BI 730357|BI 730357
15771831|NCT04680676|Drug|Placebo|Placebo
15771832|NCT04680663|Diagnostic Test|Peripheral Perfusion index|Peripheral Perfusion index is the ratio between pulsatile blood flow to non pulsatile blood flow or static blood in the peripheral tissue
15771833|NCT04680663|Diagnostic Test|serum lactate level|Blood lactate (product of metabolism) level is maintained by a cycle of continuous production and metabolism allowing it to be kept within normal values
15771834|NCT04680650|Drug|Anesthesia was maintained with sevoflurane|After endotracheal intubation, anesthesia was maintained with 1.5-3% sevoflurane, 0.3-0.5 μg/kg/h dexmedetomidine and 2-4 μg/mL target-controlled infusion of remifentanil in the group DS.
15771835|NCT04680650|Drug|Anesthesia was maintained with propofol|After endotracheal intubation, anesthesia was maintained with 2-4 μg/mL target-controlled infusion of propofol, 0.3-0.5 μg/kg/h dexmedetomidine and 2-4 μg/mL target-controlled infusion of remifentanil in the group DP.
15771836|NCT04680637|Drug|Efavaleukin Alfa|Administered as a subcutaneous (SC) injection.
15771837|NCT04680637|Drug|Placebo|Administered as a subcutaneous (SC) injection.
15771838|NCT04680637|Other|Standard of Care|Standard of care procedures and therapies for managing active systemic lupus erythematosus will be carried out according to each investigator's standard procedures.
15771839|NCT04680624|Procedure|Fecal sample collection|During the study, patients will be ask to collect fecal samples using sample collection kits. A total of 4 stool samples per patient will be collected.
15771840|NCT04680611|Other|no study intervention. Patients receive standard clinical care|no intervention. observational study
15771841|NCT04680598|Drug|PD-1 inhibitor|Patients received PD-1 inhibtor, such as pembrolizumab, toripalimab, nivolumab, sintilimab, camrelizumab
15771842|NCT04680598|Drug|Antiviral Prophylaxis|Patient received concurrent antiviral prophylaxis, such as tenofovir, entecavir
15771843|NCT04680585|Other|Enhanced Usual Care|A standardized handout with information on what treatment options might be useful to start with based on EPDS score and stage of pregnancy or postpartum.
15771844|NCT04680585|Other|MOVIN Care Platform|Virtual collaborative care intervention with a stepped care approach in which a care coordinator directs participants to one or more evidence-based virtual interventions as appropriate.
15771845|NCT04680572|Procedure|arthroplasty|arthroplasty for fracture neck of femur
15771846|NCT04680559|Behavioral|MCBI|The topics covered in the sessions are: Week 1: Introduction to mindfulness and attention to breathing. Week 2. Open awareness of bodily sensations. Week 3: Work with thoughts, introductory theory and practice in attention to sounds. Week 4: Working with thoughts, advanced theory and practice in mental landscape. Week 5: Introductory theory and practice in labeling emotions. Session 6: Advanced theory in working with emotions and practice in difficult emotions. Week 7: Introductory theory on self-compassion and compassion. Practice in self-compassion. Week 8: Practice in compassion and active compassion (acts of kindness and shared humanity).
15771847|NCT04680559|Behavioral|Active Comparator|Free observation of the psychotherapist's own feelings, thoughts, distractions, biases and behavior in general for 8 weeks. Observations of these variables are recorded during psychotherapy sessions with patients participating in the research.
15771848|NCT04680533|Device|Transcutaneous Electrical Nerve Stimulation (TENS) - Type 1|Quell TENS device. The device is worn on the upper calf right below the knee and secured by an elastic band. The device is controlled by an App and alternates between treatment periods and rest periods. Participants will be asked to wear the device 7-8 hours per day alternating legs.
15771849|NCT04680533|Device|Transcutaneous Electrical Nerve Stimulation (TENS) - Type 2|Quell TENS device with modified settings. The device is worn on the upper calf right below the knee and secured by an elastic band. The device is controlled by an App and alternates between treatment periods and rest periods. Participants will be asked to wear the device 7-8 hours per day alternating legs. It has different timing settings for the treatment and rest periods than the Type 1 device.
15771850|NCT04680520|Other|Experimental (Doublebase Gel® or Diprobase Cream®)|Emollient (Doublebase Gel® or Diprobase Cream®) use on the skin. The emollient should be applied at least once a day.
15771851|NCT04680520|Other|Best practice skin care advice booklet|This is a booklet containing advice on best practice skin care. This will contain information on avoiding soap etc.
15771852|NCT04680494|Other|moderate intensity physical exercise|
15771853|NCT04680494|Other|high intensity physical exercise|
15771854|NCT04680494|Other|rest|
15771855|NCT04680481|Device|Transcranial alternating current stimulation|Traveling wave transcranial alternating current stimulation will be applied at 4 Hz and 23 Hz over frontal and parietal brain areas in a randomized counterbalanced order.
15771856|NCT04680468|Drug|Belantamab mafodotin|2.5 mg/kg IV
15771857|NCT04680455|Other|Resistance Training + (RT+)|Body weight exercises (i.e., squats, tricep dips, lunges, and push-ups)
15771858|NCT04680442|Drug|Trastuzumab|Trastuzumab is a HER-2 targeting monoclonal antibody that improves overall survival and reduces the risk of recurrent disease in early stage HER-2 positive breast cancer.
15771859|NCT04680442|Drug|Pertuzumab|Pertuzumab (also called 2C4, trade name Perjeta) is a monoclonal antibody used in combination with trastuzumab and docetaxel for the treatment of metastatic HER2-positive breast cancer; it also used in the same combination as a neoadjuvant in early HER2-positive breast cancer
15771860|NCT04680442|Drug|Trastuzumab emtansine|Ado-trastuzumab emtansine is approved to treat: Breast cancer that is HER2 positive and has already been treated with a taxane and trastuzumab.
15771861|NCT04680429|Drug|RP7214|Participants will receive single and multiple ascending doses of RP7214
15771862|NCT04680429|Drug|Placebo|Participants will receive single and multiple ascending doses of matching placebo
15771863|NCT04680403|Other|Exercise|supervised exercise paired with coaching on behavior change techniques over 12 weeks (3 weekly sessions) and will have monthly phone follow-ups and clinic follow-ups after 3 and 6 months.
15772019|NCT04679012|Drug|Prednisone|Prednisone will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. Prednisone will be given orally.
15771866|NCT04680364|Other|partnered dance|Dance classes consisted of different choreographies, which include rhythmic and simple movements typically of ballroom/standard dances (Waltz, Tango, Viennese Waltz).
15771867|NCT04680351|Procedure|phrenic stimulation|measurements of the hemodynamic effects of phrenic stimulation
15771868|NCT04680338|Diagnostic Test|CMR stress perfusion imaging|CMR stress perfusion imaging with feedback of clinically actionable findings to general practitioner and participant
15771869|NCT04680325|Dietary Supplement|Juice daily consumption|Single-service bottles of juice were provided for 15 days of daily consumption in each arm
15771870|NCT04680286|Drug|Methadone Hydrochloride|Single dose, intravenous bolus, 0,1 mg/kg administered at induction of anesthesia.
15771871|NCT04680286|Other|Placebo|Single dose, intravenous bolus. Administered as the experimental arm.
15771872|NCT04680273|Drug|[14C]-GDC-9545|Participants will receive a single oral dose of [14C]-GDC-9545 capsule, 30 milligrams (mg) (not more than 4.6 MBq [124 μCi]) with approximately 240 millilitres (mL) water in the fasted state.
15771873|NCT04680273|Drug|GDC-9545 Solution for Infusion|Treatment B: 30 mg GDC-9545 as a Solution for Infusion, 3 mg/mL administered intravenously in 10 mL as an infusion over 30 minutes.
15771874|NCT04680273|Drug|GDC-9545/F12 Capsule|Treatment C: GDC-9545/F12 capsule, 30 mg, administered with approximately 240 mL water.
15771875|NCT04680273|Drug|GDC-9545/F18 Capsule|Treatment D: GDC-9545/F18 capsule, 30 mg, administered with approximately 240 mL water.
15771876|NCT04680260|Other|Standard of care|Patients will be offered adjuvant chemotherapy according to standard of care. Follow up will be performed with imaging according to standard guidelines, equal to the experimental arm. Blood samples will be analyzed retrospectively to evaluate the ctDNA status.
15771877|NCT04680260|Other|Circulating tumor DNA guided treatment approach|Circulating tumor-marker positivity will lead to escalation with 6 months of intensified chemotherapy consisting of 4 months of FOLFOXIRI followed by 2 months of 5FU monotherapy. Circulating tumor-marker negativity will based on shared decision-making lead to de-escalation i.e. possibilities for observation in patients otherwise eligible for monotherapy or observation/monotherapy in patients, otherwise eligible for combination chemotherapy according to standard of care.
15771878|NCT04680247|Procedure|VA-LCP|Surgery using the VA-LCP implant
15771879|NCT04680247|Procedure|NCB-PT|Surgery using the NCB-PT implant
15771880|NCT04680234|Procedure|DMEP kit|Superficial Cryotherapy using dimethyl ether and propane (DMEP) at -57C
15771881|NCT04680234|Device|Dermapen|Under aseptic precautions, the dermapen was moved on the alopecic patches diagonally, vertically and horizontally 4 to 5 times in each direction Pin point bleeding was taken as an end point
15771882|NCT04680221|Drug|Liposomal bupivacaine|Deposition of liposomal bupivacaine
15771883|NCT04680221|Procedure|TAP block|Transversus abdominis plane block performed to deposit anesthetic
15771884|NCT04680221|Drug|Deposition of saline|Deposition of saline
15771885|NCT04680208|Procedure|Surgical procedure under anesthesia|Different varieties of surgical procedures done under anesthesia
15771886|NCT04680195|Drug|Thalidomide|"The patients were treated with thalidomide tanken orally every night for 4 months, and the treatment period was divided into induction period and maintenance period, as follows:
~Induction period:
~The oral dose of thalidomide started at 50 mg, and increased to 100 mg after one week if tolerable, and maintain 100 mg for three weeks. The medication time was 1 month.
~Maintenance period: The oral dose of thalidomide was 50-75mg/d. The medication time was 3 months."
15771887|NCT04680182|Procedure|Suction drain|Suction drain either kept for three weeks or gradually pulled out.
15771888|NCT04680169|Device|Bronchoscopic intubation through AuraGain LMA|Comparing two different SGAs as conduit for bronchoscopic tracheal intubation
15771889|NCT04680169|Device|Bronchoscopic intubation through I-gel SGA|Comparing two different SGAs as conduit for bronchoscopic tracheal intubation
15771890|NCT04680156|Drug|Previously treated with EN3835 up to 1.74 mg or Placebo in EN3835-210 or the pivotal phase 3 studies|No treatment to be administered - Observational only
15771891|NCT04680143|Drug|Systemic erythropoietin injection|Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days).
15771892|NCT04680130|Drug|C-11 PiB|Completing PET scan looking for amyloid protein
15771893|NCT04680130|Drug|AV1451 Tau|Completing PET scan looking for tau protein
15771894|NCT04680117|Other|Blood collection|"Blood collection with samples of 15ml max by subject (case or control) at J0, M6 and M12:
~subject less than 5 kg : 1.8 to 4.5 ml max
~subject 5 kg to 10 kg : 4.5 to 9 ml max
~subject 10 kg to 15 kg : 9 to 13.5 ml
~subject 15 kg to 20 kg : 13.5 to 15 ml max"
15771895|NCT04680117|Other|Saliva sample|Saliva sample by subject at J0
15771896|NCT04680117|Other|Nasal|Nasal brushing by subject at J0
15771897|NCT04680091|Drug|Pyrotinib Maleate|single oral dose, 400 mg, fed.
15771898|NCT04680091|Drug|Efavirenz|single oral dose, 600 mg, fasted, at bedtime.
15771899|NCT04680078|Procedure|Placement of three interrupted sutures after Triangular Three-snip Punctoplasty of the lower punctum|A Nettelship dilator is used to enlarge the stenotic lacrimal punctum. A single blade of a small Westcott spring scissor or Vannus scissor is placed within the ampulla of the lacrimal canaliculus, with the remaining blade placed on the conjunctival surface of the posterior aspect of the eyelid. The first vertical snip is made at the vertical canaliculus. The second vertical snip is made from the edge of the first snip to create a flap. The final horizontal snip was made at the base. The triangular flap is removed and three sutures are placed, in an interrupted manner, at the posterior wall of the ampulla using 10-0 nylon. The sutures are removed 1 week after the surgery.
15771900|NCT04680078|Procedure|Conventional Triangular Three-snip Punctoplasty of the lower punctum|A Nettelship dilator is used to enlarge the stenotic lacrimal punctum. A single blade of a small Westcott spring scissor or Vannus scissor is placed within the ampulla of the lacrimal canaliculus, with the remaining blade placed on the conjunctival surface of the posterior aspect of the eyelid. The first vertical snip is made at the vertical canaliculus. The second vertical snip is made from the edge of the first snip to create a flap. The final horizontal snip was made at the base. The triangular flap is then removed .
15771901|NCT04680065|Biological|AAV2-GDNF gene therapy|Bilateral image-guided infusion of AAV2-GDNF into putamen, single dose
15771902|NCT04680065|Procedure|Sham (Placebo) Surgery|Bilateral partial burr/twist holes without dural penetration
15771903|NCT04680052|Drug|tafasitamab|tafasitamab will be administered IV for 12 cycles
15771904|NCT04680052|Drug|rituximab|Rituximab will be administered IV on cycles 1 - 5
15771905|NCT04680052|Drug|lenalidomide|Lenalidomide will be administered PO for 12 cycles
15771906|NCT04680052|Drug|placebo|placebo will be administered IV for 12 cycles
15771907|NCT04680039|Device|Continuous monitoring|Identifying intradialytic hypotension using a PPG-based wearable monitor
15771908|NCT04680026|Drug|HBI-3000|Small molecule, multi-ion channel blocker
15771909|NCT04680026|Drug|Placebo|Normal saline
15771910|NCT04680000|Behavioral|Brief Cognitive Behavioral Therapy for Chronic Pain (BCBT-CP)|BCBT-CP is the standard of care for behavioral management of acute and chronic pain in the Defense Health Agency Stepped Care Pain Pathway. BCBT-CP is a 7-module, CBT-based intervention for the treatment of acute and chronic pain in the primary care setting. The BCBT-CP manual was developed in a collaboration between the Defense Health Agency and the Department of Veterans Affairs as an intervention tailored for use by Behavioral Health Consultants embedded in Military Health System primary care clinics and Patient Centered Medical Homes. Details on BCBT-CP content can be found in the treatment arm description section of this listing.
15771911|NCT04680000|Other|BCBT-CP Booster|The BCBT-CP Booster is a telephone or videoteleconference-based booster contact designed to extend the benefits of the standard of care BCBT-CP intervention. BCBT-CP Booster contacts are not clinical interventions (i.e., no new clinical content is provided), but are intended to help motivate patients to use BCBT-CP module content, problem-solve BCBT-CP skills practice and offer reminders for future appointments. BCBT-CP Booster content was developed using feedback from focus groups with patients who completed standard BCBT-CP treatment in a military primary care clinic. Details on BCBT-CP Booster contacts can be found in the treatment arm description section of this listing.
15771912|NCT04679987|Diagnostic Test|Holter ECG|all patients will be monitored for paroxysmal Af by holder ECG
15771913|NCT04679974|Behavioral|Melodic-based Communication Therapy|"General procedures involved in (M.B.C.T.) are as follows: 25 common first words are selected as the targets (e.g., apple, ball, car, dog, cat, eat, go, etc.). Pictures and objects will be used as stimulus items. The top 3-5 incentives as identified by parent survey will be given according to the therapies specific reinforcement schedule. All treatment and evaluation sessions will be videotaped for future/further analysis and verification purposes. For the purposes of the study design, the same 25 words will be used for all participants.
~Participants will first listen to the target word set to a melodic tone and rhythm on a compact disc (CD). Clinicians will present the stimulus item (e.g., apple) prior to beginning the steps. Therapy will then progress from clapping and singing the melody to answering sung questions and finally to answering spoken questions with the target word"
15771914|NCT04679961|Device|ApolloVue® S100 Image System (Apollo Medical Optics)|The device is an in vivo non-invasive optical coherence tomography and will be used to obtain at least 6 medical images of normal and lesional skin, respectively, for both experimental group and control group.
15771915|NCT04679948|Drug|Drug Cocktail consisting of caffeine, warfarin, omeprazole and midazolam|Reference Treatment R
15771916|NCT04679948|Drug|BI 730357|BI 730357, Test treatment T
15771917|NCT04679935|Biological|Brolucizumab|Intravitreal injection
15771918|NCT04679922|Procedure|Soft Tissue Enhancement around dental implant|Sixteen sites that are indicated for peri-implant mucosal augmentation at the time of implant placement will be selected. Sixteen sites that were met the subsequent inclusion criteria were eligible to contribute in our study were classified randomly by the sealed envelope technique into two treatment groups, 8 sites in each group. Group I (Control Group): Autogenous SCTGs harvested from the palate +dental implants *. Group II (Experimental Group): FLA **+dental implants. The allocation was withheld from the surgeon (M.H.) until just before the surgical appointment. The clinical examiner (M.S.) was masked to the treatment group for the extent of the study.Three months after implantation, the sites were located, and the thickness of the mucosa will be evaluated using the customized stent. The operculectomy will be performed following the method of Flatebo et al.,22 collecting biopsy specimens of almost constant quality and evaluating clinical thickness without mucosal distortions
15771919|NCT04679909|Biological|AdCOVID|Administered intranasally
15771920|NCT04679909|Other|Placebo|Administered intranasally
15771921|NCT04679896|Device|MagnetOs Putty|Procedure: Instrumented posterolateral spine fusion
15771922|NCT04679883|Drug|5% GLH8NDE|5% GLH8NDE as eye drops
15771923|NCT04679883|Drug|Placebo|Placebo as eye drops
15771925|NCT04679857|Other|TKA|Total Knee Arthroplasty
15771926|NCT04679844|Device|MagnetOs Putty|MagnetOs Putty use in instrumented posterolateral fusion, 7cc-10cc mixed with autograft bone in a 1:1 ratio per spine level at the randomized assigned side.
15771927|NCT04679844|Device|Autograft Bone|Autologous bone graft used in instrumented posterolateral fusion, 7cc-10cc per level mixed with bone marrow aspirate/blood per spine level at the contralateral side.
15771928|NCT04679831|Dietary Supplement|Ujiplus®|Ujiplus® flour, a nutritional supplement will be used to prepare porridge, and each child will be given a serving of 300 ml every school day for 90 days.
15771929|NCT04679831|Drug|Praziquantel 400mg|400mg of Praziquantel will be given to each child once at the beginning of the study and maize flour porridge fortified only with micronutrients cooked and served to each child, 300 ml per every school day for 90 days,
15772020|NCT04679012|Drug|Cyclophosphamide|Cyclophosphamide will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. The drug will be given by IV route.
15771930|NCT04679818|Drug|Routine opioid management|Clinical judgement will be according to their standard practice and may include interpretation of blood pressure, heart rate, diaphoresis, tearing, and pupil size. Boluses of fentanyl 1 µg/kg actual body weight (ABW), up to a maximum dose of 100 µg per bolus, can be given per clinical judgement.
15771931|NCT04679818|Device|PMD-200 Nol-guided opioid administration|PMD-200 NOL values exceeding 25 for more than 30 seconds will typically be treated with boluses of fentanyl 1µg/kg ABW, up to a maximum of 100 µg per boluses, 5-minute intervals. Towards the end of the surgery (approximately 30-45 minutes before end of surgery, based on clinical judgment), the boluses of fentanyl will be reduced to 0.5 µg/kg ABW, up to a maximum of 50 µg per boluses, 5 minutes intervals. The target of a PMD-200 NOL score below 25 will be maintained until surgery ends
15771932|NCT04679792|Diagnostic Test|Dynamic posturography|Balance evaluation
15771933|NCT04679779|Other|designed occupational therapy program|Exercises facilitating hand skill patterns will include basic reach, grasp, carry and release and the more complex skills of in-hand manipulation and bilateral hand use.
15771934|NCT04679779|Other|Wii virtual reality games|"Bowling
~Frisbee
~Basketball
~Boxing"
15771935|NCT04679766|Procedure|Ice cream cone technique with immediate implant as a flapless bone regenerative method in management of patients with labial plte dehiscence|Atraumatic extraction will be done The extraction socket will be debrided to remove any residual debris using surgical curettes Socket walls will be checked using a periodontal probe to ensure integrity of all sockets walls except the labial bone plate which must show a dehiscence. Implant placement will be done. All implants will engage at least 3 mm apical to the apical end of the socket with adequate primary stability Resorbable collagen membrane will be cut confirming to the size and shape of the defect of labial bone plate dehiscence. The membrane will be placed against internal surface of the extraction socket against the remaining buccal plate of bone. The gap between the collagen membrane and the implant fixture will be filled with xenograft particulates.The membrane will be folded in palatal direction to seal the socket in an ice cream cone shape, then will be secured using non-resorbable sutures
15771936|NCT04679753|Device|Brainsway DTMS with intermittent Theta Burst Stimulation (iTBS)|Brainsway DTMS with iTBS
15771937|NCT04679753|Device|Brainsway DTMS with High Frequency (HF) Stimulation|Brainsway DTMS with HF
15771938|NCT04679740|Device|Magmaris|MAGMARIS is indicated for improving luminal diameter in the treatment of de novo native coronary artery lesions in patients with symptomatic coronary artery disease. The reference vessel diameter should closely match the scaffold nominal diameter. The treated lesion length should be less than the nominal scaffold length.
15771939|NCT04679714|Device|Transcatheter mitral valve repair (PLAR Implant and Delivery System)|The PLAR Implant is placed on the mitral valve posterior annulus using its delivery system via femoral vein access and a transeptal puncture
15771940|NCT04679701|Device|Amparo Confidence Socket|"The Amparo Confidence Socket technology takes a different approach by starting with a prefabricated socket (https://www.amparo.world/confidence-socket-en). The socket is made from a moldable thermoplastic and has the attachment point pre-assembled. This prefabricated socket is essentially an off-the-shelf product that can be heated, then molded directly to the patient's residual limb. This removes many of the intermediate steps in traditional socket fabrication. The product's molding temperature is between 60-70 ˚C but the insulation of a silicone liner between the plastic and limb ensures safe temperatures for the patient. This process is currently used in several workshops in Europe and with approximately 50 patients currently using the product. In general, it has been shown to be safe and effective in creating below-knee prosthesis."
15771941|NCT04679688|Other|descriptive|Those who apply for IVF treatment and have an antral follicle number of 4-10 will be included in the treatment. The reason for including patients with this number of antral follicles in the study is to determine the follicle locations and to determine each growing follicle separately on the day of hCG and egg collection.
15771942|NCT04679675|Other|Usual Care|Subjects will receive Kaiser Permanente Washington standard of care.
15771943|NCT04679675|Behavioral|Education|Participants will receive an Educational Brochure describing why screening for cervical cancer is important, information about HPV and its role in cervical cancer, and different strategies for cervical cancer screening.
15771944|NCT04679675|Behavioral|Direct Mail|Participants will receive an Educational Brochure describing why screening for cervical cancer is important, information about HPV and its role in cervical cancer, and different strategies for cervical cancer screening. Participants will also receive an insert describing the home-based cervical cancer screening option and that a kit will be sent within 1 week. An HPV self-collection kit with instructions and a pre-paid return envelope (to Kaiser Permanente Washington's laboratory) will be sent to individuals with instructions on how to complete the kit.
15771945|NCT04679675|Behavioral|Opt-in|Participants will receive an Educational Brochure describing why screening for cervical cancer is important, information about HPV and its role in cervical cancer, and different strategies for cervical cancer screening. Participants will receive an Opt-in Insert describing the home-based cervical cancer screening option and how to request a kit. Individuals can request a kit by phone or through a webpage. Individuals who request a kit will receive the HPV self-collection kit with instructions and a pre-paid return envelope (to Kaiser Permanente Washington's laboratory) will be sent to individuals with instructions on how to complete the kit.
15771946|NCT04679662|Device|Transcatheter mitral valve repair (PLAR Implant and Delivery System)|The PLAR Implant is placed mitral valve posterior annulus using its delivery system via femoral vein access and a transeptal puncture
15771947|NCT04679649|Other|Manual spinal mobilisation physiotherapy|Manual spinal mobilisation is a physiotherapy technique to improve spinal mobility by gently applying pressure manually on the each segmental vertebrae by hands-on treatment of a physiotherapist.
15771948|NCT04679636|Behavioral|heart rate variability biofeedback|receive biofeedback training for heart rate variability for eight weeks
15771949|NCT04679623|Combination Product|Midazolam|Midazolam Injection, 10mg
15771950|NCT04679623|Drug|Seizalam|Seizalam, 10 mg
15771951|NCT04679597|Drug|Capecitabine|comparison of two treatments
15771952|NCT04679584|Other|Observation of different courses of SARS-CoV-2 infection in different phases (acute vs. post-acute) and settings|Oberservatory Cohorts focusing (I) on subjects after SARS-CoV-2 infection that are recruited from the general population (POP), and on subjects with acute SARS-CoV-2 infections recruited (II) in university hospital high-care settings or (III) general health care
15838064|NCT04140201|Drug|Fenofibrate 200mg|Drugs that lower lipid levels
15771953|NCT04679571|Biological|Albumin|Patients with serum albumin <3 g/L with recurrent ascites - Will receive 20 % albumin at 60 grams/week until target serum albumin of 3.0 g/L is achieved following this patients would get 40 grams of albumin every week until ascites resolution or serum albumin >3.5 g/L. Patients who achieve this target will continue with 20 gm/week until patient has complete resolution of ascites and serum albumin >3.5 gm/L this patients would receive albumin 20 gms once every 2 weeks.
15771954|NCT04679571|Drug|Standard Medical Treatment|"Standard Medical Treatment- Salt-restriction, diuretics with large volume paracentesis These patients will be put on low sodium diet (2 g/day) and will be given a combination of loop diuretic (furosemide 40-160 mg/day) and a distal acting diuretic (spironolactone 100-400 mg/day) with dose escalation by one step at a time with monitoring for side-effects. Large volume paracentesis (LVP) will be performed along with intravenous albumin (8 g/L ascites removed) as required with record of the frequency of taps.
~Follow up: 2 week, 4 weeks then every 3 months for 1 year."
15771955|NCT04679558|Drug|Chlorhexidine varnish added to the preventive protocol|Antibacterial agent varnish added to the preventive protocol
15771956|NCT04679558|Behavioral|Preventive protocol|Preventive protocol
15771957|NCT04679545|Drug|CBD|A water-soluble sublingual tablet containing 20 mg of CBD.
15771958|NCT04679545|Drug|Placebo|An inactive compound.
15771959|NCT04679532|Other|Gx sweat patch|Adhesive-backed flexible epidermal wearable regional sweat patch to collect and analyze sweat via microfluidics and colorimetric assay
15771960|NCT04679532|Other|Reference sweat patch|Adhesive Tegaderm with absorbent pad regional sweat patch to collect sweat, followed by standard benchtop gravimetry and ion chromatography methods to analyze sweat
15771961|NCT04679519|Other|Drop Jumps|Perform 100 drop jumps from 40 cm height. The protocol is divided into 5 sets of 20 repetitions. Between each repetition participants get 10 seconds, and between each set 2 minutes rest. Stand on the box, drop of the box and land with feet shoulder width apart. Then immediately bend knee to approx 45 degrees and jump straight up. Throughout each jump hands are placed on hips and should not move.
15771962|NCT04679506|Drug|Cladribine|CLAE regimen (cladribine + cytarabine + etoposide) for reinduction of R/R T-ALL/LBL
15771963|NCT04679493|Drug|XC7 100 mg single|The volunteers will receive a single dose of the ID (1 capsule once, 100 mg)
15771964|NCT04679493|Drug|XC7 200 mg single|The volunteers will receive a single dose of the ID (2 capsules once, 100 mg each)
15771965|NCT04679493|Drug|Placebo single|The volunteers will receive a single dose of the ID (1 or 2 capsules once)
15771966|NCT04679493|Drug|XC7 200 mg multiple|The volunteers will receive multiple doses of the ID during 14 days (2 capsules daily, 100 mg each)
15771967|NCT04679493|Drug|Placebo multiple|The volunteers will receive multiple doses of the ID during 14 days (2 capsules daily)
15771968|NCT04679480|Drug|Cemiplimab Injection [Libtayo]|"Investigational product: a combination of an anti-PD1 antibody (Cemiplimab) and a HHI (Sonidegib).
~Cemiplimab will be supplied as a liquid in a sterile, single-use 10 ml vial. Each vial will contain a volume of 7ml at a concentration of 50mg/ml. Cemiplimab will be prepared for infusion (as described in SmPC (Fachinformation Swissmedic) Libtayo, see Appendix) at the trial site and administered as a flat 350mg dose in 100ml NaCl 0.9% as an IV infusion over approximately 30 minutes (±10 minutes) in an outpatient setting. Each patient's dose will be administered as a flat 350mg dose in every 3 weeks, starting from week 2 of the trial.
~The Hedgehog Inhibitor used for the trial will be Sonidegib. Sonidegib is a white 200mg capsule, orally administered once daily. Sonidegib will be administered in a 2 week cycle every 4 weeks (pulsed therapy: 2 weeks on, 2 weeks off), starting from week 0 of the trial."
15771970|NCT04679454|Radiation|Phase I|To establish the recommended dose defined as the maximum tolerated dose (MTD)The dose-limiting toxicity (DLT) is defined as any G3-G4 event according to NCI CTCAE Version 4.03 scale. Dose escalation is designed as a 3+3 rule-based study. Dose escalation will be initiated from a baseline dose of 18 Gy and increased to reach 21 Gy and 24 Gy. The population size includes 18 patients.
15771971|NCT04679454|Radiation|Phase II|The recommended dose from the phase I study is delivered, using Cyberknife in order to evaluate the efficacy measured in terms of pCR rate. The population size includes 61 patients.
15771972|NCT04679441|Device|The Computerized Functional Skills Assessment and Training Program|The CFSAT program provides training on everyday tasks critical to independent living (e.g., financial and medication management). The program currently includes six domain simulations critical to independent living: ATM Banking/Financial Management, Online Banking, Prescription Refill via Voice Menu, Kiosk Ticket Purchase, Online Shopping (and prescription refill), and Medication Management.
15771973|NCT04679441|Device|Brain HQ Double Decision|Cognitive speed training program
15771974|NCT04679415|Drug|hzVSF-v13|Dosage form: hzVSF-v13 40 mg/mL in a 5 mL vial Frequency: Dose at Day 1, 3, 7
15771975|NCT04679415|Drug|Placebo (Normal saline solution)|Dosage form: 0.9% NaCl Solution Frequency: Dose at Day 1, 3, 7
15771976|NCT04679402|Other|Carbon monoxide 200 ppm in air|Low dose carbon monoxide
15771977|NCT04679389|Drug|Placebo|administered orally or enterally
15771978|NCT04679389|Drug|Acetazolamide|administered orally or enterally
15771979|NCT04679376|Drug|Atorvastatin (40 mg daily)|administered in tablet or capsule form
15771980|NCT04679376|Other|Placebo|administered in tablet or capsule form
15771981|NCT04679363|Other|Active release technique|ART will be performed on upper trapezius and sternocleidomastoid, starting from 5 repetitions in 1st and 2nd week and progressing to 10 repetitions in 3rd week. ART will be performed in supine position with a pillow under knees. After the shortened area of the targeted muscle is identified, soft tissue mobilization with active movement and passive overpressure will be applied. The active movement in technique will be from shortened position of muscle to lengthened position.
15772021|NCT04679012|Drug|Hydroxydaunomycin|Hydroxydaunomycin will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. The drug will be given by IV route.
15772022|NCT04678999|Behavioral|Mind-body exercise and education|The intervention will delivered via a secure Zoom video platform.
15771982|NCT04679363|Other|Post isometric relaxation|PIR will be performed on upper trapezius and sternocleidomastoid muscles, starting from 5 repetitions in 1st and 2nd week and progressing to 10 repetitions in 3rd week. The patient will be instructed to move the ear towards the shoulder of the affected side, against the resistance of the therapist's hands with minimum force (only 20% of their total force). The patient will be instructed to perform isometric contraction of the affected side along with inhalation and position for 10 seconds. Then the patient will exhale completely and relax. During this relaxation phase head and neck are taken further away from ipsilateral shoulder and ipsilateral shoulder is pushed downward until next restriction is met.
15771983|NCT04679350|Drug|hzVSF-v13|Drug: hzVSF-v13 Dosage form: hzVSF-v13 40mg/mL in a 5mL vial Frequency: Dose at Day 1, 3, 7 Other names: a humanized monoclonal antibody (mAb)
15771984|NCT04679350|Drug|Placebo (Normal saline solution)|Dosage form: 0.9% NaCl solution Frequency: Dose at Day 1, 3, 7
15771985|NCT04679311|Biological|High ACE Activity Fresh Frozen Plasma|Subjects will be treated with fresh frozen plasma that has been preselected for ACE activity content of ≥ 50 U/L
15771986|NCT04679311|Other|Normal Saline|Subjects will be treated with normal saline 500 cc
15771987|NCT04679259|Diagnostic Test|Blood sampling for assessment of the level of D-Amino Acid Oxidase, D-serine and Serine in blood|Blood sampling is done before surgery and at 1, 2, and 7 day after surgery. The level of D-Amino Acid Oxidase, D-serine and Serine in blood are assessed.
15771988|NCT04679259|Diagnostic Test|Neurocognitive test|Neurocognitive test is performed before surgery and at 7 day after surgery
15771989|NCT04679259|Diagnostic Test|Assessment of delirium|Postoperative delirium is assessed daily during 7 days after surgery.
15771990|NCT04679246|Behavioral|Participatory intervention|Surveillance in compliance with the regulation of the sale of food in school buildings, according to official guidelines Training for the preparation of hygienic and healthy food for the personnel in charge of food sale Promotion of the consumption of simple water and healthy foods Reconditioning of the infrastructure for the consumption of simple water, free and healthy food, and the realization of physical activity Organization of events and support in the coordination of groups that promote physical activity at the community level Optimization of physical education classes at school sites Implementation of health promotion and care actions in the school context Development of skills in the school community for health care and generation of healthy school environments Creation and strengthening of health and nutrition committees in schools, with the participation of directors, teachers and parents to generate necessary and permanent conditions that favor healthy environments
15771991|NCT04679233|Other|Prescription aerobic exercise|high intensity interval training, 5 weeks, 2 sessions/week - supervised by a clinician.
15771992|NCT04679220|Procedure|Preheating|For preheating RC prior to placement, a device called Therma-flo TM RC warming kit (Vista, Wisconsin, USA) was used according to manufacturer's instructions to preheat resin composites
15771993|NCT04679207|Procedure|Vacuum-assisted excision|Vacuum-assisted biopsy (VAB) is a minimally invasive technique performed under local anaesthetic as an outpatient procedure by radiologists using x-ray or ultrasound guidance. It was developed in the USA in the mid 1990s and has become well established as a diagnostic test for suspected breast disease. It uses the combination of a large gauge biopsy needle and suction to allow larger pieces of tissue to be removed than can be obtained with a standard needle biopsy device. The technique is used widely for diagnostic purposes and, in some centres, for the therapeutic removal of benign breast lumps such as fibroadenomas and papillomas.
15771994|NCT04679194|Biological|Mana 312|"Mana 312 is a cellular product comprised of expanded T cells derived from allogeneic donor leukocytes that have been stimulated with monocyte derived dendritic cells pulsed with tumor-associated antigen (TAA) peptide mixes for 3 antigens: Wilms Tumor gene 1 (WT 1), the preferentially expressed antigen of melanoma (PRAME), and Survivin.
~Each Mana 312 product is specifically matched for an individual subject and will be manufactured from leukocytes from the same donor who provided stem cells to that subject for their current allogeneic hematopoietic stem cell transplantation (HSCT)."
15771995|NCT04679181|Other|Telemedecine|telemedical consultation
15771996|NCT04679155|Behavioral|Eating Time Restriction|early vs late time of day restriction
15771997|NCT04679142|Drug|Baclofen Tablets|Enrolled patients will receive treatment and evaluations for their disease as determined by their physicians in accordance with local standard of care. Visits will be scheduled by their physician according to patient-specific needs and national clinical practice.
15771998|NCT04679129|Drug|ASC42|Oral tablets
15771999|NCT04679129|Drug|Placebo|Oral tablets
15772000|NCT04679116|Procedure|Laparoscopic bilateral inguinal hernia repair|Laparoscopic bilateral inguinal hernia repair
15772001|NCT04679116|Procedure|Open bilateral inguinal hernia repair|Open bilateral inguinal hernia repair
15772002|NCT04679103|Biological|Eculizumab (JSC GENERIUM, Russia)|Eculizumab
15772003|NCT04679090|Other|Exercise Program|Participants will exercise twice a week for twelve weeks total.
15772004|NCT04679077|Other|Cytocam-IDF imaging device|Observation of the microcirculation
15772005|NCT04679064|Drug|Niraparib|PARP-inihibitor
15772006|NCT04679064|Drug|Dostarlimab|PD-1 inihibitor
15772007|NCT04679064|Drug|Pegylated liposomal doxorubicin|Chemotherapy drug
15772008|NCT04679064|Drug|Paclitaxel|Chemotherapy drug
15772009|NCT04679064|Drug|Gemcitabine|Chemotherapy drug
15772010|NCT04679064|Drug|Topotecan|Chemotherapy drug
15772011|NCT04679064|Drug|Bevacizumab|Chemotherapy drug
15772012|NCT04679051|Behavioral|Sleep duration|Participants will be asked to alter time in bed to achieve specified sleep durations.
15772013|NCT04679038|Biological|SHR-1701|Intravenous (IV) on Day 1 of each cycle
15772014|NCT04679038|Drug|Famitinib|Famitinib, po, qd
15772015|NCT04679025|Other|Exposure - postoperative hyperglycemia|Postoperative hyperglycemia (blood or capillary glucose > 10.0 mmol/L) within 72 hours of a surgical procedure
15772016|NCT04679012|Drug|Polatuzumab Vedotin|Polatuzumab vedotin will be administered as an IV infusion at 1.8mg/kg on Day 1 of each cycle, every 21 days.
15772017|NCT04679012|Drug|Rituximab|Rituximab will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. The drug will be given by IV route.
15772018|NCT04679012|Drug|Etoposide|Etoposide will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. The drug will be given by IV route.
15772024|NCT04678973|Behavioral|Self-compassion mindfulness practice|"Guided Mindfulness Practice: Participants in the intervention group will receive compassion-based guided meditation audio recordings. Recordings will target self-compassion and body concerns simultaneously.
~Psychoeducation: Participants in the intervention group will receive psychoeducation delivered via daily PDF over days 1-6. Psychoeducation will orient users to their upcoming experience, provide education about internalized weight bias, the chronic stress system, the utility of self-compassion practice to regulate physiological and psychological targets, and guidance on establishing, maintaining, and generalizing a mindfulness practice.
~Daily prompts: Participants will receive a text message every morning indicating their task for that day.
~Weekly prompts: Participants will receive a text message at the end of every week (Days 7, 14, 21, and 28) with a link to a brief adherence survey."
15772025|NCT04678960|Behavioral|Trust-based Relational Intervention Group Training|"The intervention (Trust-based Relational Intervention® TBRI®) uses a youth-centered, attachment-based, and trauma-informed approach to strengthen youth/safe adult relationships and improve youth self-regulation (thinking, emotions, and behavior). TBRI includes TBRI Group Training and TBRI In-Home Coaching.
~TBRI Group Training is comprised of three components: TBRI Youth Group Training (youth only), Caregiver Training (caregivers only), and Nurture Groups (youth-caregiver joint roleplay activities), which is conducted prior to youth's release."
15772026|NCT04678960|Behavioral|Trust-based Relational Intervention In-Home Structured Coaching|"The intervention (Trust-based Relational Intervention® TBRI®) uses a youth-centered, attachment-based, and trauma-informed approach to strengthen youth/safe adult relationships and improve youth self-regulation (thinking, emotions, and behavior). TBRI includes TBRI Group Training and TBRI In-Home Coaching.
~TBRI In-Home Structured Training includes four structured in-home coaching sessions."
15772027|NCT04678960|Behavioral|Trust-based Relational Intervention In-Home Responsive Coaching|"The intervention (Trust-based Relational Intervention® TBRI®) uses a youth-centered, attachment-based, and trauma-informed approach to strengthen youth/safe adult relationships and improve youth self-regulation (thinking, emotions, and behavior). TBRI includes TBRI Group Training and TBRI In-Home Coaching.
~TBRI In-Home Responsive Training includes at least 2 structured in-home coaching sessions plus additional sessions indefinitely as needed."
15772029|NCT04678934|Procedure|TAVR|Transcatheter aortic valve replacement
15772030|NCT04678921|Drug|TJ210001|human anti-C5aR monoclonal antibody
15772031|NCT04678908|Drug|HB0025|Patients will be assigned to dose regimens in the order of enrollment, and they will receive their assigned fixed dose of HB0025 via intravenous infusion.
15772032|NCT04678895|Drug|Naltrexone|Capsule with doses of 1.5mg, 3mg, and 4.5 mg to allow for drug titration. Capsules of different dosages will be indistinguishable to allow for maintenance of blinding.
15772033|NCT04678895|Drug|Placebo|Naltrexone matched placebo capsule.
15772034|NCT04678882|Drug|Placebo|Pharmaceutical form:solution for injection Route of administration: subcutaneous (SC)
15772035|NCT04678882|Drug|Dupilumab SAR231893|Pharmaceutical form:solution for injection Route of administration: subcutaneous (SC)
15772036|NCT04678869|Drug|Ciprofloxacin|prophylactic ciprofloxacin (10mg/kg BD, enteral/IV)
15772037|NCT04678869|Drug|Antibiotic|Standard of care antibiotic as per local policy
15772038|NCT04678856|Drug|Dupilumab SAR231893|Pharmaceutical form:Injection solution Route of administration: Subcutaneous
15772039|NCT04678856|Drug|Placebo|Pharmaceutical form:Injection solution Route of administration: Subcutaneous
15772040|NCT04678843|Behavioral|Virtual Family-Based Treatment|Treatment involving the youth/adolescent who has been diagnosed with anorexia nervosa and their family, delivered virtually via videoconferencing.
15772041|NCT04678830|Drug|Placebos|Placebos
15772042|NCT04678830|Drug|Leronlimab (700mg)|Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
15772043|NCT04678804|Procedure|Mucogingival surgery for single recession coverage|"The control group will be treated with a coronally advanced flap with vertical incisions (CAF) associated to an autologous connective tissue graft. The graft will be harvested from the palate in the area apical to the gingival margin of the second molar with an epithelial-connective harvesting technique to obtain a connective graft of 1 mm in thickness.
~Subsequently, the graft will be shaped in order to match height and width of the recipient site on the recession according to the technique proposed by Zucchelli in 2003. The test group will receive the same flap design with the same technique, then the porcine derived xenogeneic graft will be shaped in order to match height and width of the recipient site on the recession. In particular, the matrix will be reduced in thickness as suggested by the manufacturer to obtain a standardized thickness of 3 mm."
15772044|NCT04678791|Drug|Nimotuzumab|Patients receive Nimotuzumab 400 mg each time, once a week, slow intravenous drip, for a total of 6 weeks.
15772045|NCT04678791|Drug|Cisplatin|Patients receive 40 mg/m2, d1, 7 days as 1 treatment cycle, 6 treatment cycles in total
15772046|NCT04678791|Radiation|External-beam radiation|Patients undergo IMRT/VMAT radiotherapy with pelvic and/or extended field irradiation at a total dose of 45 - 50.4 Gy; 1.8 - 2.0 Gy/f, 25 - 28 f.
15772047|NCT04678791|Radiation|Brachytherapy|Patient undergo Brachytherapy with high dose rate, with a total dose of 30-40 Gy and a cumulative dose of 80 ~ 85 Gy at point A/HRCTV D90; if the tumor diameter is ≥ 4 cm, the cumulative dose of ≥ 87 Gy at point A/HRCTV D90.
15772048|NCT04678778|Behavioral|Physical and Cognitive Activity|There are three sessions a week for the course of 12 weeks. Each session consists of 5 trials.
15772063|NCT04678648|Drug|RSC-1255 Dose Escalation|Phase 1a will enroll 24-34 participants to identify the dose limiting toxicity (DLT), recommended Phase 1b dose, and the safety and tolerability of RSC-1255. RSC-1255 is administered orally twice daily, without food. Each cycle is 21 days.
15774313|NCT04660708|Behavioral|manual physical therapy|Previously described in the arm description
15772049|NCT04678765|Procedure|Ultrasound-guided distal peripheral nerve block|"To localize the median nerve, the ultrasound transducer will be placed in a transverse orientation proximally to the wrist cease at mid-forearm level, with a slight tilt distally towards the hand. An in-plane ultrasound-guided medial-to-lateral puncture will be made and 3ml of 2% lidocaine was injected within the fascia that envelopes the median nerve.
~To perform the ulnar block, an ultrasound transducer will be placed in a transverse orientation over the ulnar side of the distal forearm. An in-plane ultrasound-guided medial-to-lateral or proximal-to distal puncture will be made and 3 ml of 2% lidocaine will be infiltrated into the fascial plane to block the ulnar nerve. Finally, we will apply a circumferential subcutaneous infiltration of 4 ml 2% lidocaine at the radial side of the wrist, 2cm proximal to the styloid process of the radius to block the terminal sensory branches of the radial, musculocutaneous, and medial antebrachial cutaneous nerves that may reach the palmar crease."
15772050|NCT04678765|Procedure|Ultrasound-guided quadruple-injection axillary nerve block|"The US probe will be applied in the axilla to obtain a short-axis view of the axillary artery. The following 4 nerves will be identified as hyperechoic structures: the median, ulnar, and radial nerve surrounding the axillary artery and the musculocutaneous nerve in the fascial layers between the biceps and coracobrachialis muscles.
~A total volume of 20 mL lidocaine 2% will be administered divided over 4 locations. The needle is inserted in-plane from the anterior aspect of the axillary artery and directed toward the posterior aspect of the axillary artery to first anesthetize the radial nerve. The posteriorly located radial nerve is surrounded with 8 mL of local anesthetic. Afterward, the needle is withdrawn and redirected to the median and ulnar nerves, after which another 8 mL of local anesthetic is deposited. In the end, the needle is withdrawn and redirected toward the musculocutaneous nerve where another 4 mL of local anesthetic is deposited."
15772051|NCT04678752|Other|Weight management care path|"Documentation and data capture built in the Electronic Health Record
~Clinical data support that suggests weight loss approach(es)
~Tracking of weight loss progress and weight loss maintenance during patient visits to guide the patient-clinician conversation
~Diagnosis and billing in EHR automatically adds the diagnosis of overweight or obesity and links the most common weight-related co-morbidities to ensure adequate provider reimbursement
~Evidence-based online training on weight management for clinicians
~Practice quality improvement and training for use of PATHWEIGH for weight-prioritized visits through practice coaches/facilitators
~Consultation support by practice facilitators with implementing PATHWEIGH and by obesity providers for clinicians with creating patient treatment plans"
15772052|NCT04678752|Other|Control|"Within primary care the option to select Obesity brief HPI, this is a brief historical intake of a patient's weight - when either they or their clinician decides to have a weight-prioritized visit. It is intended to initiate a discussion regarding potential strategies for weight loss (often eat less, exercise more). The provider has the discretion to augment or add support as they see fit."
15772053|NCT04678739|Drug|Remdesivir|Remdesivir 100 IV Infusion as a lyophilized powder
15772054|NCT04678739|Drug|Tocilizumab|Actemra IV Infusion
15772055|NCT04678726|Diagnostic Test|Lung ultrasound assessment for ruling out pneumothorax|Patients who have undergone heart surgery and have decided to enroll in our study, will have the standard chest x-ray and an additional lung ultrasound. Within a maximum of two hours of the chest tube removal, the standard chest x-ray will be performed, and then a different nurse will perform the lung ultrasound to check for pneumothorax.
15772056|NCT04678713|Dietary Supplement|investigate the nutritional determinants of MFO in moderate to well-train individuals|The participants will receive a 3-day fat rich or a carbohydrate rich diet. The participants will perform a maximal fat oxidation test before and after the diet intervention to evaluate the effect of the two diets on MFO.
15772057|NCT04678713|Other|Investigate the physiological determinants of MFO in moderate to well-train individuals|Muscle biopsies will be obtained at baseline to compare muscle characteristics between well-matched train individuals with a high compared to a low maximal fat oxidation.
15772058|NCT04678700|Other|Chest physiotherapy post-covid19|"The sessions are divided into the following modules;
~Directed abdominal-diaphragmatic ventilation (10 times).
~Costal expansion exercises with the help of flexion and abduction of the upper limbs. (10 times)(1).
~Self-passive stretching of the ribcage and neck muscles, accessory to inspiration. The purpose of the stretching will be to increase the flexibility of the muscles to improve the vital capacity as has already been evidenced in other respiratory diseases such as chronic obstructive pulmonary disease (COPD) and cystic fibrosis (25)(26).
~Relaxation time;Jacobson's progressive relaxation; we scan the body's condition.
~Post-session evaluation by taking the respiratory frequency/ min and the Borg's dyspnea index, and level oxigen after the exercises."
15772059|NCT04678687|Procedure|Liver, lung, heart and kidney biopsy|Liver, lung, heart and kidney biopsies will be performed on each case in the COVID-19 group.
15772060|NCT04678674|Procedure|tooth root augmentation|Autogenous tooth roots for lateral alveolar ridge augmentation and staged implant placement.
15772061|NCT04678661|Device|Smartphone application and web portal|"My Dose Coach is indicated for single patient use outside the clinic setting by a previously diagnosed Type 2 Diabetic who has been prescribed a once-daily long-acting basal insulin. MDC is intended as an aid to the patient to provide dose suggestions based upon the HCP's independent professional judgment. Before My Dose Coach can be used, the HCP configures the dose instructions for the specific patient and activates the application using the specific patient Instructions. The application uses the dose plan instructions provided by the patient's HCP to provide dose suggestions of once-daily long-acting basal insulin (i.e. basal insulin titration) that are based on the patient's Fasting Blood Glucose (FBG) as well as hypoglycemia occurrence.
~MDC includes a Maintenance Module designed to support patients in maintaining proper insulin dosingby enabling logging of administered doses of prescribed diabetes medications and BGM and providing dosing and measurement reminders."
15772062|NCT04678661|Behavioral|Standard Insulin Therapy Education|Standard best practices for training patients to administer insulin therapy include 1) a thorough patient assessment prior to therapy initiation to address barriers, including evaluation for diminished cognitive capacity or other problem that may impair safe insulin self-administration, and assessment of health literacy and numeracy skills; 2) observation of a patient's injection practice, with re-education provided as needed; 3) use of appropriate language is necessary when teaching injection technique; 4) dose preparation, which includes inspecting the insulin dose for accuracy (following manufacturer instructions); and 5) review of signs, symptoms and treatment of hypoglycemia must be included as a critical component of the training.
15838065|NCT04140201|Drug|Omega 3 fatty acid|Drugs that lower lipid levels
15772064|NCT04678648|Drug|RSC-1255 Dose Expansion|Phase 1b will enroll 48-104 participants to further characterize the safety, pharmacology, and clinical efficacy of RSC-1255. RSC-1255 is administered orally twice daily, without food. Each cycle is 21 days.
15772065|NCT04678635|Other|Chronic transcranial direct current stimulation|Chronic transcranial direct current stimulation
15772066|NCT04678622|Device|Bioferula3D|Custom splint with 3D technology classified as a custom medical device
15772067|NCT04678609|Other|Exercise|CKC: exercise with joints fixed on the ground OKC: exercise with joints not fixed on the ground
15772068|NCT04678596|Device|EonAligner|EonAligner system is one stage system.
15772069|NCT04678596|Device|Clearfix|Clearfix system is three-stage system.
15772070|NCT04678583|Procedure|Resection of colorectal liver metastases|Comparison of two liver surgery methods
15772071|NCT04678570|Other|White Noise|"The infants will be listened to a song Called  Bebeginiz Aglamasin from Orhan Osman's colic album which was prepared with the help of Dr. Harvery Karp's ''The Happiest Baby'' album through a portable speaker located at 50 cm away from the infant at 55-decibel frequency.
~Listening to this song will start 5 minutes before the insertion of the Orogastric Tube, will continue during the procedure and another 5 more minutes after the procedure is completed. The rest of the noise in the environment will be controlled."
15772072|NCT04678570|Other|Swaddling Method|The preterm infants will be placed in the supine position on a 90 cm2 soft cloth. The upper edge of the cloth will be aligned with the infant's shoulder, with the arms placed close to the body, with the horizontal ends of the cloth folded in the opposite direction to cover the top of the body. The arms will be put into flexion and the body will be covered with a cloth. In order not to limit the movements of all limbs of the preterm infant, attention will be paid to leave a finger space between the infant and the cloth cover and to leave a suitable space for the feet to be comfortable before folding the lower part of the cloth cover forward. In the swaddling method, the baby's head can move freely. The swaddling method will be applied approximately 5-10 minutes before the procedure and will be removed from the infant 5 minutes after the procedure. Because swaddling will increase the body temperature of the infant, the standard temperature of the incubator will be lowered.
15772073|NCT04678557|Combination Product|VC-01 Combination Product|PEC-01 cells loaded into an Encaptra Drug Delivery System
15772074|NCT04678544|Device|Scalp cooling system 2|The investigational device which will be used in this study is the Paxman Scalp Cooling System 2. This device is manufactured by: Paxman Coolers Limited. This is a free-standing, electrically-powered, mobile refrigeration unit which circulates a refrigerated liquid coolant, at a pre-set temperature and flow rate, through a cooling cap which is attached to, and covers, the top of the patient's head. The Paxman Scalp Cooling System is intended to be used for scalp cooling of patients who are receiving chemotherapy for the treatment of solid tumors, in order to reduce the risk of chemotherapy-induced alopecia.
15772075|NCT04678531|Drug|Swabs containing tea tree oil and chamomile oil|Swabs will be used in 26 patients for 8 weeks and will be discontinued in the following 4 weeks.
15772076|NCT04678531|Drug|Baby shampoo|Baby shampoo will be used in 23 patients for 8 weeks and will be discontinued in the following 4 weeks.
15772077|NCT04678518|Diagnostic Test|Inflammatory makers that will include Interleukins (IL); IL1, IL2, IL6 and TNF|1 hour before decannulation and 3 times after decannulation (1 hours, 12 hours and 24 hours)
15772078|NCT04678505|Drug|MK-3402|"MK-3402 administered as a single dose of 100 mg IV infusion on the following dosage days:
~Panels A to D: Day 1 Panel E: Day 1 in Periods 1 and 2"
15772079|NCT04678492|Drug|Esomeprazole|High-dose esomeprazole and amoxicillin dual therapy: given for 14 days at a dose of esomeprazole 40mg 1 tablet TID plus amoxicillin 500 mg 2 capsules TID
15772080|NCT04678492|Drug|Amoxicillin|High-dose esomeprazole and amoxicillin dual therapy: given for 14 days at a dose of amoxicillin 500 mg 2 capsules TID plus esomeprazole 40mg 1 tablet TID
15772081|NCT04678492|Drug|Bismuth|Bismuth-containing quadruple therapy: given for 14 days at a dose of bismuth 110 mg 2 capsules BID plus esomeprazole 40 mg 1 tablets BID，tetracycline 250mg 2 capsules TID and furazolidone 100mg 1 tablets BID
15772082|NCT04678492|Drug|Esomeprazole|Bismuth-containing quadruple therapy: given for 14 days at a dose of esomeprazole 40mg 1 tablet BID plus bismuth 110 mg 2 capsules BID，tetracycline 250mg 2 capsules TID and furazolidone 100mg 1 tablets BID
15772083|NCT04678492|Drug|Tetracycline|Bismuth-containing quadruple therapy:given for 14 days at a dose of tetracycline 250mg 2 capsules TID plus furazolidone 100mg 1 tablets BID，esomeprazole 40 mg 1 tablets BID and bismuth 110 mg 2 capsules BID
15772084|NCT04678492|Drug|Furazolidone|Bismuth-containing quadruple therapy:given for 14 days at a dose of furazolidone 100mg 1 tablets BID plus tetracycline 250mg 2 capsules TID，esomeprazole 40 mg 1 tablets BID and bismuth 110 mg 2 capsules BID
15772085|NCT04678479|Drug|Ganaxolone|ganaxolone
15772086|NCT04678466|Biological|flotetuzumab|CD123 x CD3 bispecific DART® antibody
15772087|NCT04678453|Biological|SNK01|Patient-specific ex vivo expanded autologous natural killer cells
15772088|NCT04678440|Drug|[18F]F-AraG Imaging|Total body PET imaging using [18F]F-AraG
15772089|NCT04678427|Other|6 Minute Walk Functional Test|Complete 6-minute walk test
15772090|NCT04678427|Behavioral|Behavioral Intervention|Participate in walking and other activities
15772091|NCT04678427|Other|Survey Administration|Complete survey
15772092|NCT04678427|Behavioral|Timed Get Up and Go Test|Complete timed get up and go test
15772093|NCT04678414|Behavioral|Healthcare Activity|Attend focus group
15772094|NCT04678414|Other|Survey Administration|Complete survey
15772095|NCT04678401|Radiation|Radiation|Total Myeloid and Lymphoid Irradiation (TMLI) delivered through Radiation Oncology institutional standards
15772096|NCT04678401|Drug|Fludarabine|Given intravenously -10 to -6 days prior to hematopoietic stem cell transplant (HSCT)
15772097|NCT04678401|Drug|Thiotepa|Given intravenously on day -10 and day- 9 prior to hematopoietic stem cell transplant (HSCT)
15772098|NCT04678401|Drug|Cyclophosphamide|Given intravenously with Mesna on day -8 and day- 7 prior to hematopoietic stem cell transplant (HSCT)
15772099|NCT04678401|Drug|Mesna|Given intravenously with Cyclophosphamide on day -8 and day -7 prior to hematopoietic stem cell transplant (HSCT)
15772100|NCT04678401|Biological|Treg-enriched donor cell|Given intravenously -4 day prior to hematopoietic stem cell transplant (HSCT)
15772101|NCT04678401|Biological|Unmodified donor T Cell|Given intravenously -1 day prior to hematopoietic stem cell transplant (HSCT)
15772102|NCT04678401|Procedure|CD34+ Haplo Peripheral Blood Stem Cell|CD34+ Haplo Peripheral Blood Stem Cell Transplantation
15772103|NCT04678388|Drug|Reference drug|1 Cap., single oral administration under fasting condition
15772104|NCT04678388|Drug|Test drug 1|1 Tab., single oral administration under fasting condition
15772105|NCT04678388|Drug|Test drug 2|1 Tab., single oral administration under fasting condition
15772106|NCT04678375|Diagnostic Test|Retinal diseases diagnosed by artificial intelligence algorithm|An artificial intelligence algorithm was applied to diagnose referral diabetes retinopathy, referral age-related macular degeneration, referral possible glaucoma, pathological myopia, retinal vein occlusion, macular hole, macular epiretinal membrane, hypertensive retinopathy, myelinated fibers, retinitis pigmentosa and other retinal lesions from fundus photography.
15772107|NCT04678362|Drug|Talazoparib + Avelumab|Patients will receive the combined treatment until the investigator considers that the patient no longer obtains benefit from it. The treatment will be continued until disease progression, unacceptable toxicity or discontinuation for any cause.
15772108|NCT04678349|Dietary Supplement|PHGG|Subjects will be given 4 scoops (40g) PHGG, which provide 160kcal, 0.24g protein, 30.4g soluble fibre, 40g carbohydrate and 0g sugar, once allowed orally.
15772109|NCT04678349|Other|conventional care|follow low fibre diet and anti-diarrhea drugs
15772110|NCT04678336|Biological|CART123 cells; cyclophosphamide; fludarabine|CART123 cells following lymphodepleting chemotherapy in pediatric patients with relapsed/refractory AML. Subjects will be treated with a single IV dose of CART123 cells on Day 0.
15772111|NCT04678323|Drug|Lifestyle Management|Participants in this group will receive lifestyle management.
15772112|NCT04678310|Other|Support from the hospital palliative and end of life care volunteer service (developed for this study).|Hospital palliative and end of life care volunteer service: a volunteer service to provide support to patients dying in the hospital and their families. The volunteer service has been designed to provide presence and companionship to dying patients at the end of life, and their families.
15772113|NCT04678297|Behavioral|Physical activity + emotion regulation intervention|The intervention meet twice weekly for 12 weeks, 1.25 hrs./session. This intervention will be led by certified instructors trained in working with back pain patients. The instructor leads participants through a series of physical activity exercises at a slow-moderate pace. Participants will be asked to practice every day for 20 minutes to maximize the benefit of the intervention. Participants also receive a home practice manual containing some basic, safe postures that can be performed on days they are not attending the formal in-person sessions.
15772114|NCT04678297|Behavioral|Physical activity control intervention|The interventions meet twice weekly for 12 weeks, 1.25 hrs./session. This intervention is designed to require a similar amount of physical exertion. Classes involve conventional exercises appropriate for patients with CLBP, including a comprehensive set of exercises that stretch all the major muscle groups, with an emphasis on the trunk and legs. The intervention will include all 12 stretching exercises used in the exercise intervention of previous studies that have successfully used it in comparison to yoga, plus 3 additional stretches (hip internal rotators, hip adductors and hip flexion).Participants will be asked to practice every day for 20 minutes home as well. Printed handouts will be provided to facilitate home practice. In addition, a video demonstrating all the exercises will be provided to assist participants in practicing safely. Classes will be led by a licensed physical therapist who has previous experience leading exercise classes.
15772115|NCT04678284|Behavioral|Diabetes Homeless Medication Support (D-Homes)|There will be 10 sessions offered within 12 weeks to participants. Sessions will last 30-60 minutes. During sessions a diabetes wellness coach will use behavioral activation and motivational interviewing to get to know participants and set goals to improve diabetes care. The coach will encourage a focus on medication adherence behaviors to the extent that participants are willing. The coach will also help with resource and care coordination. The coach will also provide brief diabetes education as needed.
15772116|NCT04678271|Behavioral|AFIX-OB Quality Improvement Package|Practices randomized to the intervention arm will be provided with a package of core and supplemental quality improvement interventions to choose from so that the most effective combination for their practice is implemented. Each practice will be required to implement a tablet-based educational app for patients, and evidence based online educational module for providers, standing order protocol, and a reminder/recall protocol. They can then choose to also use flyers and posters in their waiting rooms, standardized talking points for maternal immunization for the providers, educational content for the practice website, and laminated and highlighted CDC Vaccine Information Sheets. The recruited patients and providers at the practice will be given a baseline and follow-up survey to assess their knowledge, attitudes, and beliefs towards maternal immunization.
15772117|NCT04678258|Procedure|HR electroanatomic mapping and MVG catheter ablation|High resolution CTI mapping using the mini-electrodes at the 8 mm catheter tip followed by voltage guided ablation
15772118|NCT04678258|Procedure|Conventional bipolar mapping and linear catheter ablation|Bipolar mapping and conventional anatomic linear catheter ablation
15772119|NCT04678245|Behavioral|Above the Influence-Vaping (ATI-V)|Peer-nominated 8th grade and 9th grade Peer Leaders (PL) will be trained in a half day ATI-V training. Adult Advisors (AA) will attend a half day ATI-V AA training and the PL training. The training day builds leadership skills in the PLs, develops skills for rising above pressure to vape including identification of personal reasons to rise, identification of healthy support people, teaching accurate use statistics, and sharing stories of prior success in rising above negative pressures. The ATI-V team of PLs and AAs then will run four interactive messaging campaigns to reach the rest of the student body. These four campaigns are (1) Introduction to ATI-V and My Reasons to Rise (2) Gain and Loss (3) Who's Got My Back (4) The Facts. Each campaign features a portion in which PLs model healthy norms and behaviors, and a second portion in which all the rest of the students engage in an interactive component to build and demonstrate the target skill.
15772120|NCT04678232|Behavioral|Positive Processes and Transition to Health (PATH)|See arm/group description for details regarding this intervention
15772121|NCT04678219|Other|Dietary Intervention|Subjects will be placed on 1 of 2 diets for a treatment period of 8 weeks with the support of dietitians; it will then be evaluated whether they can continue this diet on their own for 4 weeks.
15772122|NCT04678206|Drug|BLU-5937|Oral administration of BLU-5937 Tablets
15772123|NCT04678206|Drug|Placebo|Oral administration of matching placebo for BLU-5937 Tablets
15772228|NCT04677478|Other|Impact of respiratory isolation on quality of life|Semi-structured interviews
15772124|NCT04678193|Drug|Coromec Registry with ECL-19|Glycocheck to assess Microvascular Score will be used on all patients. An algorithm-based identification of symptoms and objective evidence using care coordination and remote sensor driven technology
15772125|NCT04678180|Behavioral|Combined HRT and ERP|tic training using the principles of HRT and ERP as to reduce tic intensity
15772126|NCT04678167|Diagnostic Test|Caloric test|Lying, patientwill be placed so that he can introduce water (hot then cold) into his external ear canal. It is the reaction of the vestibular system (sensory organ responsible for balance) which is then measured with a helmet placed over his eyes and which measures the nystagmus (movement of the eye) which reflects vestibular activity.
15772127|NCT04678167|Diagnostic Test|Measurement of the speed of Nystagmus|A helmet with an infrared camera will be placed in front of patient eyes. This will allow visualizing on screen and measuring eye movements spontaneous or induced in the dark by various tests.
15772128|NCT04678167|Diagnostic Test|Angle of deviation at Fukuda|The patient will be asked to trample on the spot (30 steps) with the indexes pointed forward. In the event of vestibular asymmetry, the patient turns at a varying angle to the right or to the left. This will then measure what is called the angle of deflection of the fukuda.
15772129|NCT04678167|Diagnostic Test|Alexander's degree of nystagmus|"there are 3 degrees:
~Degree I: nystagmus that exists only when the eyes are turned to the right.
~Degree II: also exists when the eyes are to the right or to the front.
~Degree Ill: exists when the eyes are on the right, front, or left"
15772130|NCT04678167|Other|EHTEV questionnaire|Handicap Scale for Balance Disorders and Vertigo
15772131|NCT04678167|Other|EEV questionnaire|European Vertigo Assessment Questionnaire
15772132|NCT04678167|Other|anxiety VAS|visual analog scale of anxiety
15772133|NCT04678154|Drug|Standard of care|Participants in the control group will receive standard of care treatment for their injury, to include all institution specific standard treatment (prophylactic and otherwise) for preventing and treating infection.
15772134|NCT04678154|Drug|Vancomycin and Tobramycin|The patients in the SEXTANT cohort will have 1000 mg of Vancomycin and 1200 mg of Tobramycin administered to the wound surface, fracture site and exposed hardware (if any) just prior to suture closure of the wound or flap. The SEXTANT cohort will then receive at least 72 hours of systemic antibiotic therapy targeted to the modern wound bioburden.
15772135|NCT04678141|Other|Dyract XP (Dentsply De Trey), Kerr Herculite Classic (Kerr Corporation),R&D Series NOVA(Kuraray Medical Inc) Clearfil TM SE Bond (Kuraray Medical),Hydrocal LC (Medicept Dental)|compomer (Dyract XP,R&D Series NOVA) , composite (Kerr Herculite Classic),Bonding (Clearfil TM SE Bond), Dycall (Hydrocal LC)
15772136|NCT04678128|Behavioral|Dance4Healing Telehealth Live Zoom Sessions|"Week 1: 2-hour introduction session on Zoom platform with a live dance instructor at the participant's desired level of activity intensity (low, mild, or moderate).
~Weeks 2-8: All participants will be asked to participate in a 1 hour online, instructor-led live class."
15772137|NCT04678128|Behavioral|Dance Buddy|"Following randomization (beginning of intervention period) half of the participants will be assigned a dance buddy, and will be asked to dance with their buddies using the Dance4Healing TLVP at least 2 additional times/week. This group will have 24/7 access to Dance4Healing Platform during the intervention and post-intervention periods."
15772138|NCT04678115|Device|Magnetic Levator Prosthesis (MLP)|Neodymium magnet embedded in a glasses frame and a polymer embedded (PDMS) micro-magnet array fitted externally to the upper lid with IV 3000 securement film. The IV 3000 is FDA approved for extended wear on the skin.
15772139|NCT04678115|Device|Kinesiotape Frontalis Sling (KTFS)|Kineso Tape is FDA registered as a 510K exempt class 1 device, typically used by physical and occupational therapist to support muscular healing and movement. It is sometimes used on the face in cases of facial palsy or on the eye lid to support the lid in cases of severe blepharoptosis. In such cases it may be attached near the lid margin above the lashes extending up to the forehead skin overlying the frontalis muscle. Alternatively it may be a very short piece attached only along the lid skin. The tape is easily removed.
15772140|NCT04678102|Drug|PHI-101 administration|Escalated doses of PHI-101 will be administered to each cohort.
15772141|NCT04678089|Drug|Bortezomib|Objective To observe the safety and efficacy of bortezomib related biomarkers. Including genes, metabolites, etc
15772142|NCT04678076|Drug|Ketoprofen Lysine|A single oral dose of test product - ketoprofen 25 mg/5 ml oral gel stick pack - will be administered to healthy male and female volunteers under fed conditions in two consecutive study periods with a wash-out interval of at least 7 days between the two administrations.
15772143|NCT04678076|Drug|Ketoprofen Oral Product|A single oral dose of reference product as a single dose of half of a bipartite sachet of OKi® 80 mg granules for oral solution will be administered to healthy male and female volunteers under fed conditions in two consecutive study periods with a wash-out interval of at least 7 days between the two administrations.
15772144|NCT04678063|Other|Exposure to Placebo|Patients are exposed to placebo in the EEC
15772145|NCT04678063|Other|Exposure to dose A and dose B of cat allergen|Patients are exposed to dose A and B for successive exposures in the EEC
15772146|NCT04678063|Other|Exposure to a single dose of cat allergen|Patients are exposed to a single dose of cat allergen in the EEC according to the dose selected to achieve the main objective (dose A or B)
15772147|NCT04678050|Drug|Ketamine/ propofol|ketamine/propofol mixture, each mL contains 5 mg of ketamine plus 10 mg of propofol). A loading dose of 0.125 mL/kg will be administered intravenously (IV) over 10 min, followed by maintenance infusion at a rate of 0.05-0.125 mL/kg/h.
15772148|NCT04678050|Drug|Dexmedetomidine|Dex solution (4 µg/mL). A loading dose of 2 µg/kg will be administered IV over 10 min, followed by a maintenance infusion of 0.1-1 µg/kg/h
15772149|NCT04678037|Behavioral|PROs assessment using sickle cell disease mobile app (SCD-app)|A smartphone app platform designed for patients with sickle cell disease. The SCD-app is programmed to send notification to patients to complete PROs assessment. The SCD-app is able to collect PROs data as patients complete the assessment using the app platform.
15772150|NCT04678011|Procedure|Personalized surveillance and intervention protocol|This study uses one arm. Participants will undergo endoscopic surveillance with intervals between 6 months and 2 years, depending on severity of polyposis and performed endoscopic interventions.
15772151|NCT04677998|Procedure|Personalized surveillance and intervention protocol|This study uses one arm. Participants will undergo endoscopic surveillance with intervals between 3-6 months and 5 years, depending on severity of polyposis and performed endoscopic interventions.
15772152|NCT04677985|Combination Product|Menthol based topical analgesic|Topical analgesic or placebo was applied to upper and lower body muscles and tendons and pain pressure threshold was measured with a handheld algometer.
15772153|NCT04677972|Drug|Ebselen|Glutathione peroxidase mimetic
15772154|NCT04677972|Drug|Placebo|Matching placebo containing excipients
15772155|NCT04677959|Drug|Fluticasone propionate/salmeterol (FS)|FS administered via electronic multidose dry powder inhaler (eMDPI) Digital System (DS) with component devices including smart device application (App), Digital Health Platform (DHP), and provider-facing dashboard
15772156|NCT04677959|Drug|Albuterol|Albuterol administered via electronic multidose dry powder inhaler (eMDPI) Digital System (DS) with component devices including smart device application (App), Digital Health Platform (DHP), and provider-facing dashboard
15772157|NCT04677959|Drug|Standard of Care Asthma Medication|Current inhaled corticosteroid(ICS)/Long-acting beta agonist(LABA) and any additional controller medication for asthma
15772158|NCT04677959|Drug|Standard of Care Rescue Medication|Current rescue medication
15772159|NCT04677946|Other|High Linoleic Acid Healthy Cookies|High Linoleic Acid Healthy Cookies (containing about 9g of linoleic acid) 1 per day for 8 weeks
15772160|NCT04677933|Drug|A: OLP-1002|10 patients will receive 5 µg OLP-1002 twice-weekly (BIW) OLP-1002
15772161|NCT04677933|Drug|B: OLP-1002|10 patients will receive 10 µg OLP-1002 BIW OLP-1002
15772162|NCT04677933|Drug|C: Placebo|10 patients will receive Placebo BIW
15772163|NCT04677920|Other|High Linoleic Acid Healthy Cookies|High Linoleic Acid Healthy Cookies (containing about 10g of grapeseed oil) 1 per day for 2 weeks
15772164|NCT04677907|Device|Persona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesis|Persona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesis vs a Persona (Zimmer) posterior stabilised cemented prosthesis
15772165|NCT04677907|Device|Persona (Zimmer) posterior stabilised cemented Trabecular Metal™ (Tibia and Femur) prosthesis|Persona (Zimmer) posterior stabilised uncemented Trabecular Metal™ (Tibia and Femur) prosthesis vs a Persona (Zimmer) posterior stabilised cemented prosthesis
15772166|NCT04677894|Device|Laryngoscopy|During the intubation, the head of the patient was kept in a neutral position, patients were nasotracheally intubated
15772167|NCT04677881|Other|Intervention group|intervention group: bread with sourdough control group: bread with yeast
15772168|NCT04677868|Drug|Methotrexate|Methylprednisolone 1 mg/kg/day MTX (10 mg/day) was given on days 1, 3, and 8, and repeated weekly until aGVHD was less than grade II;
15772169|NCT04677855|Drug|PCUR-101|50 mg capsules
15772170|NCT04677855|Drug|Dutasteride 0.5 mg|0.5 mg capsules
15772171|NCT04677855|Drug|Abiraterone and Prednisone|500 mg tablets Abiraterone with 5 mg Prednisone Tablets
15772172|NCT04677842|Drug|ART Therapy|
15772173|NCT04677829|Biological|PNT001|30 minute infusion for PNT001 1000mg; 60 minute infusion for PNT001 4000mg
15772174|NCT04677829|Biological|%5 dextrose for infusion|30 min placebo infusion for 1000mg; 60 minute placebo infusion for 4000mg
15772175|NCT04677816|Drug|Standard of Care Neoadjuvant Chemotherapy|"Participants will receive standard of care neoadjuvant chemotherapy with doxorubicin (60 mg/m2) and cyclophosphamide (600 mg/m2) for 4 cycles and paclitaxel (80 mg/m2) weekly for 12 cycles. Doxorubicin and cyclophosphamide (AC) may be administered on a classical every 3 week or dose dense every 2-week (with growth factor support) schedule at the treating physician's discretion. Routine incorporation of carboplatin is not required, however use of carboplatin (AUC 1.5 to 2 weekly or AUC 6 on week 1, 4, 7, and 10) with paclitaxel is allowed at the treating investigator's discretion.
~Upon completion of neoadjuvant chemotherapy, all patients will undergo definitive surgery with either breast conservation or mastectomy with axillary lymph node staging. Type of surgery will be determined by the treating physician."
15772176|NCT04677816|Dietary Supplement|Vitamin D3|Participants with deficient levels of vitamin D will receive vitamin D supplementation at the initiation of chemotherapy with 50,000 IU of oral vitamin D3 (cholecalciferol) once a week to be continued for 20 weeks during neoadjuvant chemotherapy.
15772177|NCT04677816|Other|Drug Diary|Participants that will receive Vitamin D will be asked to fill out a drug diary on a daily basis. Compliance and feasibility will be assessed through a drug diary and pill counts at set time points.
15772178|NCT04677803|Drug|BT200|BT200 is a PEGylated synthetic RNA oligonucleotide
15772179|NCT04677790|Behavioral|assigned period of specific dietary restrictions|Step by step gradual introduction of egg containing food products
15772180|NCT04677777|Biological|PP-007|PP-007 is pegylated carboxyhemoglobin
15772181|NCT04677777|Other|Standard of care|Patients randomized to this treatment will not receive the experimental treatment, but will receive the standard of care at the institution.
15772182|NCT04677764|Other|virtual reality|Wii Fit balance board (Nintendo Inc., Kyoto, Japan).
15772183|NCT04677764|Other|Standard of care|physical therapy and occupational therapy exercises either at their own home or a gym
15772187|NCT04677712|Drug|QWO™(CCH-aaes) + No Mitigation Treatment|Cohort 1 will serve as a control and no mitigation treatment will be administered
15772188|NCT04677712|Drug|QWO™(CCH-aaes) + Compression|Participants will use compression garments
15772189|NCT04677712|Drug|QWO™(CCH-aaes) + Cold Packs|Participants will use cold packs
15772190|NCT04677712|Drug|QWO™(CCH-aaes) + Arnica gel|Participants will use Arnica Gel Patches
15772191|NCT04677712|Drug|QWO™(CCH-aaes) + INhance®|Participants will use INhance®
15772192|NCT04677712|Drug|QWO™(CCH-aaes) + PDL|Participants will be treated with PDL
15772193|NCT04677699|Diagnostic Test|Combined Risk Score|Several factors will be analyzed to assign each subject combined risk score. This will assess the subject's risk of developing Type 1 Diabetes and/or Celiac Disease.
15772194|NCT04677686|Behavioral|Bundle of Care|Hair removal with Clipper Glucose Control Preoperative antibiotics Repeat antibiotics after 4 Hours Optimize Body temperature Instrument change for colorectal anastomosis Use of wound protectors Experienced surgeon Preoperative showering
15772195|NCT04677673|Drug|Chemotherapy|Modified SOX Chemotherapy regimen A cycle consists of Day 1: Oxaliplatin 100mg/M2 intravenous Day 1-14 Tegafur gimeracil oteracil potassium capsule 60mg/M2 oral (twice daily) Repeated every 22nd day
15772196|NCT04677673|Procedure|Curative gastrectomy|Radical gastrectomy with D2 lymph node dissection
15772197|NCT04677660|Biological|TAK-919|TAK-919 intramuscular injection
15772198|NCT04677660|Biological|Placebo|Placebo intramuscular injection
15772199|NCT04677647|Other|OurChild mHealth Digital Platform|The intervention being created and tested in this study is OurChild an integrated mHealth/EHR app, initially designed for the Chinese American community in Sunset Park, Brooklyn. All participants will be assigned to either beta versions undergoing development, or to version 1.0.
15772200|NCT04677634|Dietary Supplement|ISOThrive Prebiotic Nectar|The test material is ISOThrive. It is an approximately 90% pure maltosyl-isomalto-oligosacchride (MIMO) prebiotic syrup produced by bacterial fermentation/bio-conversion of sucrose and maltose. It is taken 1g daily.
15772201|NCT04677621|Other|Nurse Telehealth|Subjects will receive nurse telehealth Mobile Decision Support System (MAP) DBS care
15772202|NCT04677621|Other|STANDARD DBS|Subjects will receive standard in-person clinic-based DBS care administered without the use of Mobile Decision Support System (MAP) DBS
15772203|NCT04677595|Drug|Capmatinib|400 mg of capmatinib tablets, administered orally twice daily
15772204|NCT04677582|Behavioral|Vidas Activas, famiLias saludablEs (VALE)|Families and Children allocated to the intervention will receive weekly group-based meetings over a 10-week period consisting of education and activities on healthy lifestyles. Graduate students/Research Assistants trained in nutrition, exercise and clinical psychology will lead the meetings. All activities will be culturally relevant (i.e. cooking healthy Latino recipes) and Spanish speaking students will be recruited to deliver the intervention. Participants will be involved on deciding activities and projects and while some sessions will meet as a family group with parents/guardians, others will meet separately.
15772209|NCT04677556|Other|Esogastric pressures measurement|"Catheter placement : at least 2 hours after and within 24 hours following the initial ventilation support establishment (CPAP or NiPPV according to usual practice and clinical conditions). 2 periods of measurements : with the initial and with the 2nd ventilation support using a cross-over for each patient. For each period, the first serie of measurements will be carried out without modifying the settings of the support ( clinical setting), and the second one using esogastric pressures by adjusting the settings of the ventilation support in order to obtain an optimal normalization or reduction of the amplitude of the Pes and Pdi deltas (physiological setting). 5 minutes of spontaneous breathing with/without oxygen between period 1 and 2 (depending on the patient's conditions). All measurements will be performed for 5 minutes after a 15 minutes quiet breathing. After measurements, the optimal respiratory support will be continued."
15772210|NCT04677543|Drug|ALIS|Inhalation via nebulization over approximately 6 to 15 minutes.
15772211|NCT04677543|Drug|Azithromycin|Oral tablet
15772212|NCT04677543|Drug|Ethambutol|Oral tablet
15772213|NCT04677543|Drug|ELC|Inhalation via nebulization over approximately 6 to 15 minutes.
15772214|NCT04677530|Drug|JNJ-40411813|JNJ-40411813 will be administered orally.
15772215|NCT04677530|Drug|Matching Placebo|Matching placebo will be administered orally.
15772216|NCT04677517|Device|Modification of active microphone positioning|"Patient will pass the experimental tests described above with 3 different active microphone positions :
~on the cochlear implant processor;
~on the antenna
~in front of the external ear canal
~Patient will pass the tests 1 week after each microphone position change, so that they can get used to the new position in their everyday life."
15772217|NCT04677517|Behavioral|SPHERE protocol|"Patient's 3D localization in noise will be assessed thnks to a 3D localization system called SPHERE based on virtual reality.
~Data from spatial hearing perception will be recorded in three-dimensional space (azimuth, elevation, and depth). First, the pointing error will be computed separately for azimuth, elevation, and depth, in terms of constant error (absolute and signed) and variable error. Then, these separate errors will be combined into a cumulative error 3d-D (the 3d-D value), hence summarizing all three space dimensions, and taking into account absolute and variable error in one measure."
15772218|NCT04677517|Behavioral|French Matrix Test|This test assesses the intelligibility threshold defined as the noise level (in decibels) for which the subject can repeat 50% of the words heard (in dichotic listening), resulting in an Speech Recognition Threshold (SRT) value
15772219|NCT04677517|Behavioral|Quality of life questionnaire|The Speech, Spatial and Qualities of Hearing Scale short-form with 15 items (SSQ15) questionnaire is performed in order to evaluate auditory abilities of patients in different daily life situations.
15772220|NCT04677517|Behavioral|Likert scale|This subjective evaluation will be added to evaluate difficulties and self-confidence felt by participants during the SPHERE protocol and the French Matrix Test.
15772226|NCT04677491|Drug|Ospemifene 60 mg|Ospemifene vs placebo
15772227|NCT04677491|Behavioral|fMRI experiments|Participants will see sexually explicit video clips that alternate with non-sexual clips and neutral color projection and b) smell alternate pheromones with clear air and pine aroma.
15772229|NCT04677465|Device|RheOx Bronchial Rheoplasty|bronchial rheoplasty is a staged procedure wherein pulsed electric fields are delivered to the right lung in the first treatment visit, and then the left lung is treated approximately 1 month later.
15772230|NCT04677465|Device|Sham Procedure|staged sham procedure wherein bronchoscopy is performed, the catheter is inserted into the right lung, but energy is not delivered; then the same steps are performed in the left lung approximately 1 month later (no energy is delivered to the patient)
15772231|NCT04677452|Biological|JWCAR129|Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JWCAR129. During JWCAR129 production, participants may receive bridging chemotherapy for disease control. Following successful generation of JWCAR129 product, participants will receive a course of lymphodepleting chemotherapy followed by one dose of JWCAR129 administered intravenously (IV).
15772232|NCT04677439|Drug|Flumatinib|600 mg of Flumatinib orally daily for 24 months
15772233|NCT04677426|Drug|Hyperpolarized Xe129|Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to assess patients with cHP and IPF.
15772234|NCT04677413|Radiation|Ultrafractionated radiotherapy for rectal cancer|To determine the toxicity of dose-escalated hypofractionated RT, in patients with locally advanced rectal cancer treated with RT, FOLFOX or CAPOX chemotherapy and selective omission of surgery.
15772235|NCT04677400|Other|More than Body Appearance (MBA) Intervention|"The MBA intervention is a structured 2-weeks psychological intervention. Participants will receive psychoeducational online materials pertaining body image (1st week) and will be required to produce writing assignments pertaining body image in terms of body functionality (2nd week).
~During the first week of intervention participants receive psychoeducational online materials pertaining to: positive and negative body image; body image disorders; risk and protective factors for body image; relationship and influences between body image and physical activity, including reasons for exercise; what is body functionality and why it is important.
~During the second week participants produce 3 structured writing assessment pertaining to body functionality and why it is important."
15772236|NCT04677387|Behavioral|Nalox-comm Training Module|The online communication module will be 30-60 minutes. Content will include: 1) using non-judgmental language, 2) how to raise the topic of overdose (OD) and naloxone with patients in a non-threatening manner; 3) videos modeling how to initiate the conversation with patients and caregivers; 4) considerations in how to communicate differently with patients versus caregivers; and 5) addressing pharmacists' perceived barriers to naloxone counseling. Pharmacists can receive continuing education credit (0.1 CEU) for completing the course.
15772237|NCT04677387|Behavioral|Prescribe to Prevent: Overdose Prevention and Naloxone Rescue Kits for Prescribers and Pharmacists|A 55 minute long online module with videos, didactic content, and quizzes that covers the following topics: risk factors for overdose (OD), how to respond to OD, how naloxone works, types of naloxone, how to administer naloxone, medico-legal issues, how to bill for naloxone, and strategies to address overdose. Pharmacists can receive continuing education credit (0.125 CEUs) for completing the course.
15772238|NCT04677374|Other|Standard of care|Standard of care referral approach which is a brief health talk conducted once every morning by a VMMC mobilizer.
15772239|NCT04677374|Behavioral|Intensified Health Education|More detailed health talk conducted during each group health talk session by the VMMC mobilizer, brochures describing VMMC, its benefits and how to access the service and testimonies from men who have successfully undergone VMMC
15772240|NCT04677374|Behavioral|SMS/telephonic Tracing|SMS tracing to remind participants of VMMC appointments
15772241|NCT04677374|Behavioral|Transportation Reimbursement|Transportation reimbursement to offset the cost of transportation for VMMC appointments
15772242|NCT04677361|Combination Product|MILs™ in Combination with Pembrolizumab|Efficacy and Safety of MILs™ in Combination with Pembrolizumab in Patients with NSCLC and SCLC
15772243|NCT04677348|Procedure|Pericapsular nerve group (PENG) block|ultrasound-guided PENG block with 0.3% ropivacaine 20cc
15772244|NCT04677348|Procedure|Fascia iliaca compartment block (FICB)|ultrasound-guided suprainguinal FICB with 0.3% ropivacaine 30cc
15772245|NCT04677335|Dietary Supplement|AB-LIFE with Monacolin K|Red yeast rice extract (also known by its scientific name, Monascus purpureus) certified to contain 10 mg of monacolin K, plus 1 billion total cfu of AB-LIFE probiotic formula, which is composed of 3 Lactoplantibacillus plantarum (formerly known as Lactobacillus plantarum) strains: CECT7527 (also known as KABP011™), CECT7528 (also known as KABP012™) and CECT7529 (also known as KABP013™), all in a maltodextrin carrier. Capsules are of vegetable origin (hydroxypropylmethyl cellulose).
15772246|NCT04677335|Other|Placebo|Placebo capsules containing maltodextrin carrier only. Capsules are of vegetable origin (hydroxypropylmethyl cellulose).
15772247|NCT04677322|Drug|Adult patients diagnosed and treated for high blood pressure|Educational program interventions conducted by primary care staff to encourage adherence to a low-sodium diet consisting of direct action on the patient and provision of educational materials will be assessed. Compliance and follow-up of the low sodium diet will be done by monitoring the sodium in urine in the target population, selected according to the selection criteria described in the protocol.
15772248|NCT04677296|Other|VS002A|Amino acid based ORS/Medical food
15772249|NCT04677296|Other|WHO-ORS|WHO Oral rehydration solution, which is glucose based
15772250|NCT04677270|Behavioral|Digital problem solving tool|Digital problem solving tool - adapted for practical and emotional problems during the COVID-19 pandemic
15772251|NCT04677257|Procedure|PCI, invasive coronary physiology and CMR|Patients with acute STEMI will undergo invasive assessment of coronary physiology (IMR and CFR) following successful primary PCI and CMR within a week of the acute event
15772252|NCT04677244|Procedure|Blood sample in portal vein|A 6 ml blood sample will be taken from the portal vein, before and after the echo-endoscopic biopsy of the pancreatic mass. The second sample will be taken after the biopsy if there is no bile drainage, or after bile drainage if indicated. The delay between the end of the biopsy procedure and the puncture will be 5 minutes. A 6 ml peripheral blood sample will also be taken before and after the endoscopic procedure.
15772288|NCT04676906|Drug|NNC0113-6861|Study compound 1 - Each participant will receive a single intravenous (i.v) dose of [14C]-NNC0113-6861
15772289|NCT04676906|Drug|NNC0113-6860|Study compound 2 - Each participant will receive a single i.v dose of [14C]-NNC0113-6860
15772290|NCT04676906|Drug|NNC0113-6891|Study compound 3 - Each participant will receive a single i.v dose of [14C]-NNC0113-6891
15772253|NCT04677218|Procedure|Arthroscopic ACL reconstruction with retensioned hamstring autograft|After diagnostic arthroscopy, an oblique, 5-cm oblique skin incision is made below the joint line over the proximal edge of the pes anserine.Then fascia will be incised the fascia in an L-shaped fashion. After the releasing the distal end of tendons ,tendons will be harvested in their direction via tendon strippers.During the graft preparation phase firstly femoral tunel will be drilled from AM portal with knee flexed 120 degrees. The drill will be aligned parallel to the tibial plateau and exit through LFC.Then tibial guide wire will be sent from graft incision to the tibial tunel and drilled for desired direction.Once the adjustable loop button is deployed to the graft, it will be pulled through the tunnels and the button is slipped on lateral femoral cortex.After making sure that the button will be slipped , tibial fixation will be provided with one bioabsorbable screw and staple.After tibial fixation, the femoral loop will be retensioned in group 2 patients.
15772254|NCT04677218|Procedure|Arthroscopic ACL reconstruction with retensioned and knotted hamstring autograft|After the same preparation procedure as in retensioned autograft group, after tibial fixation of graft, he femoral loop will be retensioned and knotted in 3. group .
15772255|NCT04677192|Combination Product|Microwave Ablation combination with chemotherapy|Microwave Ablation combination with chemotherapy. Maximum tumor diameter ≤ 3cm, single microwave needle, maximum tumor diameter> 3cm, double ablation needle, the ablation range completely covers the lesion ≥ 0.5cm in order to obtain a satisfactory ablation margin. After the operation, contrast ultrasound is performed again to confirm the ablation edge. Enhanced MRI or CT to evaluate the ablation effect 4 weeks after surgery. Selection of chemotherapy regimen refers to the 2020 NCCN Guidelines for Pancreatic Cancer. First-line chemotherapy regimen: gemcitabine combined with albumin-bound paclitaxel or FOLFIRINOX; second-line chemotherapy regimen: If first-line chemotherapy based on gemcitabine, 5-FU-based regimen for second-line, If 5-FU-based regimen for first-line, gemcitabine for second-line.
15772259|NCT04677166|Device|Negative pressure wound therapy coupled with instillation|Use of V.A.C. VeraFlo to treat skin grafts with NPWT coupled with instillation.
15772260|NCT04677166|Device|Standard Negative Pressure Wound Therapy|standard negative pressure wound therapy via V.A.C. Ulta device at 125mmHg suction.
15772261|NCT04677153|Other|Test and treat plus peer mentors|Rapid start of HCV treatment at OTP within days of HCV diagnosis. Participants will receive 8 weeks of glecaprevir/pibrentasvir and will work with a peer mentor during and after treatment.
15772262|NCT04677153|Other|Usual care|Participants are referred to another location for HCV treatment.
15772263|NCT04677127|Behavioral|Health Belief Model and Health Literacy Level based Education and Counseling|Patients given education and counseling constructed with health belief model (perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cue to action, self-efficacy). The constructed education given through groups dichotomised by health literacy levels (low/high). Groups of 11-13, had weekly educations for 6 weeks, 6 weeks of counselling and 12 week of follow-up.
15772264|NCT04677114|Drug|Buprenorphine and Outpatient Parenteral Antibiotic Therapy|Participants will be complete IV antibiotics with OPAT. All participants will receive buprenorphine treatment of OUD.
15772265|NCT04677114|Drug|Buprenorphine and standard of care antibiotic treatment|All participants will receive treatment of OUD and the infection per usual clinical care.
15772266|NCT04677101|Diagnostic Test|Liver Biopsy|Fine-needle liver biopsy
15772267|NCT04677088|Biological|TCR-T cells|Patients will receive 1 x 10^4 cells/kg to 5 x 10^6 cells/kg bodyweight of TCR redirected T cells by IV infusion.
15772268|NCT04677075|Procedure|mastectomy|mastectomy either simple or modified radical
15772269|NCT04677062|Drug|GV-328|Patients with GV-328 treatment
15772270|NCT04677049|Drug|Niacin CRT|A controlled release technology (CRT) tablet of Niacin
15772271|NCT04677036|Other|No intervention is given|No intervention given
15772272|NCT04677023|Other|GrandioSO x-tra® bulk|The prepared cavities will be restored with GrandioSO X-tra (VOCO, Cuxhaven, Germany) in layers that are a maximum of 4 mm thick then cured for 20 seconds using using Elipar™️ S10 LED curing light (3M ESPE, St Paul, MN, USA) with light intensity of 1200 mW/cm2.
15772273|NCT04677023|Other|Admira fusion X--tra® bulk|he prepared cavities will be restored with Admira fusion X-tra®️ bulk (VOCO, Cuxhaven, Germany) in layers that are a maximum of 4 mm thick then cured for 20 seconds using usingElipar™️ S10 LED curing light (3M ESPE, St Paul, MN, USA) with light intensity of 1200 mW/cm2.
15772274|NCT04677010|Other|Cycle exercise|10 weeks of cycle exercise on a cycle ergometer with motor.
15772275|NCT04676997|Biological|Camrelizumab|200mg on days1,15 of Cycles 1-4 (Q2W); IV infusion. 200mg on day 1 of Cycles 5-8 (Q2W); IV infusion.
15772276|NCT04676997|Drug|Nab paclitaxel|125 mg/m² on day 1, 8 and 15 of Cycles 1-4 (QW 3/4); IV infusion.
15772277|NCT04676997|Drug|Epirubicin|90 mg/m² on day 1 of Cycles 5-8 (Q2W); IV infusion.
15772278|NCT04676997|Drug|Cyclophosphamide|600 mg/m² on day 1 of Cycles 5-8 (Q2W); IV infusion.
15772279|NCT04676984|Other|Consultations|The intervention will comprise a series of consultations between the patient and general practitioner (at least three), where the patient and general practitioner will continuously adjust the patient's medication according to the patient's goals, needs, and preferences.
15772280|NCT04676971|Drug|hzVSF-v13|Dosage form: 100mg / 200mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Frequency: Dose at Day 1, 3, 7, D14(if necessary)
15772281|NCT04676971|Drug|Placebo (Normal saline solution)|Dosage form: 0.9% NaCl Solution Frequency: Dose at Day 1, 3, 7, D14(if necessary)
15772282|NCT04676958|Dietary Supplement|Vitamin K2|Vitamin K2
15772283|NCT04676958|Dietary Supplement|Micro-crystalline cellulose|Micro-crystalline cellulose
15772284|NCT04676932|Other|Nursing Care Based on Kolcaba's Comfort Theory|In this study, Nursing care based on Kolcaba's Comfort Theory will be applied for women undergoing HSG.
15772285|NCT04676919|Device|phonophoresis therapy with pulsed mode ultrasound|phonophoresis therapy with pulsed mode ultrasound, five days a week for three weeks
15772286|NCT04676919|Device|phonophoresis therapy with continuous mode ultrasound|phonophoresis therapy with pulsed mode ultrasound, five days a week for three weeks
15772287|NCT04676919|Device|sham ultrasound|sham ultrasound therapy, five days a week for three weeks
15772291|NCT04676893|Drug|D418 Tab.|1T
15772293|NCT04676880|Device|Left atrial appendage occlusion (Watchman FLX or Amplatzer Amulet)|Currently, there are two devices available on the Dutch market, Watchman and Amulet. After randomization to the intervention arm, additional randomization for type of device will follow. If the amount of procedures is too small to implant two devices, the centre will implant a device of choice.
15772294|NCT04676867|Drug|Dalcetrapib|Dalcetrapib 300 mg Film-Coated Tablets
15772295|NCT04676867|Other|Placebo|Placebo Tablets
15772297|NCT04676841|Device|Conventional ventilation + instrumental tables with integrated laminar airflow|Surgical instruments protected from contamination by local laminar airflow
15772298|NCT04676841|Device|Conventional ventilation + standard instrumental tables|Control
15772299|NCT04676841|Device|Laminar airflow ventilation + standard instrumental tables|Control
15772300|NCT04676828|Diagnostic Test|Single-photon-emission CT scan|SPECT/CT scan is an established functional modality used in the diagnosis and monitoring of lung disease. SPECT/CT scan images pulmonary circulation, where perfused areas equate with normal functional lung
15772301|NCT04676815|Procedure|NBI and interventional bronchoscopy|NBI used to enhance the contrast between the mucosal surface and underlying blood vessels
15772302|NCT04676802|Drug|NSAID capsules|1, Ibuprofen 400-mg and 1, Acetaminophen 325-mg capsule per dosage
15772303|NCT04676802|Drug|Opioid capsule|1, Oxycodone 5-mg capsule and 1, placebo capsule per dosage
15772304|NCT04676789|Drug|Pegaspargase|Pegaspargase 2500IU/m2 administered by intramuscular injection on Day 1
15772305|NCT04676789|Drug|Anti-PD-1 monoclonal antibody|Anti-PD-1 antibody 200mg administered intravenously (IV) on Day 1
15772306|NCT04676789|Radiation|Definitive intensity-modulated radiotherapy (IMRT)|Definitive intensity-modulated radiotherapy (IMRT) of 50 Gy will be given in 25 days
15772307|NCT04676776|Drug|Levonorgestrel|All participants receive 1.5 mg levonorgestrel on day 1
15772308|NCT04676776|Drug|Mifepristone|All participants receive 200 mg mifepristone on day 3
15772309|NCT04676763|Drug|Substance P|Participants will receive Substance P
15772310|NCT04676763|Drug|Normal Saline|Participants will receive normal saline as Negative control
15772311|NCT04676763|Drug|Histamine|Participants will receive histamine as Positive control
15772312|NCT04676750|Behavioral|Mindfulness-Based Stress Reduction|yoga, meditation and psycho education
15772313|NCT04676737|Drug|TTHX1114(NM141)|TTHX1114
15772314|NCT04676724|Drug|GSK3228836|Participants will be administered GSK3228836.
15772315|NCT04676724|Drug|PegIFN|Participants will be administered PegIFN.
15772316|NCT04676724|Drug|NA therapy|Participants will continue to receive their NA therapy for the duration of the study.
15772317|NCT04676711|Drug|GFH312|Subjects are planned to be dosed in oral tablet, with single and multiple ascending doses
15772318|NCT04676711|Drug|Placebo|Subjects are planned to be dosed in oral tablet, with single and multiple ascending doses
15772319|NCT04676698|Behavioral|Three Good Things|"The treatment phase will last 3 weeks. However, participants will complete surveys at baseline and up to 6 months. At the end of the trial the study team will also select a limited number of entries from participants to share some of the good things which people listed. These will be edited to ensure writer anonymity and participants will be informed of this plan in the study introduction."
15772320|NCT04676698|Behavioral|Wait list control arm and then Three Good Things|Surveys will be completed for 3 months prior to treatment and then after treatment.
15772321|NCT04676685|Drug|E2730|E2730 capsules.
15772322|NCT04676685|Drug|E2730-matched placebo|E2730-matched placebo capsules.
15772323|NCT04676672|Device|Open repair|Open repair of the aortic arch and descending aorta with or without involvment of the ascending aorta using a hybrid graft.
15772324|NCT04676659|Drug|TNK-tPA|Experimental arms for low, middle, and high dosing; and active control arm for the standard protocol
15772329|NCT04676620|Procedure|CK surgery|CK and LASIK are both effective methods for the correction of hypeopia. They have been proved to offer many advantages in terms of visual acuity, corneal sensitivity, and corneal biomechanics compared with traditional refractive surgeries.
15772330|NCT04676607|Drug|SHR7390|SHR7390
15772331|NCT04676581|Other|Leech Therapy|Patient who received leeches (for more than 2 days) at the Amiens University Hospital over a period of 9 years (2010-2018)
15772332|NCT04676568|Procedure|Extravesical VVF repair|Both standard transvesical and extravesical approach for VVF repair will be utilised
15772333|NCT04676555|Drug|Ocrelizumab|There is no treatment allocation. Patients administered Ocrelizumab by prescription that have started before inclusion of the patient into the study will be enrolled.
15772334|NCT04676555|Drug|Ofatumumab|There is no treatment allocation. Patients administered Ofatumumab by prescription that have started before inclusion of the patient into the study will be enrolled.
15772335|NCT04676542|Other|Exercise|One hour of a beginning martial art class ,and a one hour walk at 4.0 mph pace.
15772336|NCT04676529|Drug|PXS-5505|PXS-5505 is a hard gelatin capsule (size 0) with the additional excipients mannitol and magnesium stearate.
15772337|NCT04676516|Drug|GSK3326595|GSK3326595 is a first-in-class small molecule PRMT5 inhibitor in form of an oral capsule.
15772338|NCT04676503|Dietary Supplement|BIOVAGINIL|Biovaginil is a notified food supplement formulated as 480 mg capsules. Each capsule contains Lactobacillus crispatus NTCVAG04 3 billion and Vitamin A 120 μg.
15839759|NCT04126200|Drug|Feladilimab|feladilimab will be administered.
15772341|NCT04676477|Drug|Patritumab deruxtecan|Intravenous infusion at a starting dose of 3.2 mg/kg Q3W
15772342|NCT04676477|Drug|Patritumab deruxtecan|Intravenous infusion at RCD 1 (and at RCD 2 if two provisional RCDs are selected in dose escalation)
15772343|NCT04676477|Drug|Osimertinib|Oral administration at 40 mg or 80 mg once daily
15772344|NCT04676477|Drug|Osimertinib|Oral administration at RCD 1 (and at RCD 2 if two provisional RCDs are selected in dose escalation)
15772345|NCT04676477|Drug|Patritumab deruxtecan|Intravenous infusion 5.6 mg/kg Q3W
15772346|NCT04676477|Drug|Patritumab deruxtecan|Intravenous infusion at the selected RCD
15772347|NCT04676477|Drug|Osimertinib|Oral administration at 80 mg once daily
15772348|NCT04676464|Diagnostic Test|Ultra- sound|Ultrasound assessment of quadricep muscle layer thickness QMLT within 72hrs of initial CT scan
15772349|NCT04676451|Device|Femto-AK|Astigmatic Keratotomy / Arcuate Incisions for the correction of astigmatism
15772350|NCT04676425|Drug|MK-8189|Administered at a dose of 4 mg via oral tablet
15772354|NCT04676399|Drug|Hydrochlorothiazide 12.5mg|(2 pills/day). Thereafter, you will take 1 pill every morning and 1 pill every evening for 28-35 days until the end of the study.
15772355|NCT04676399|Drug|Placebo|(2 pills/day). Thereafter, you will take 1 pill every morning and 1 pill every evening for 28-35 days until the end of the study.
15772356|NCT04676386|Diagnostic Test|Primary Immune Response (PIR) test by Biodesix, Inc.|Blood draw for biomarker assessment will be performed at these time-points: pretreatment, start of 3rd cycle and investigator assessed progression. The biomarker analysis will be performed retrospectively.
15772357|NCT04676373|Drug|ALGLUCOSIDASE ALFA|"Pharmaceutical form:solution for infusion
~Route of administration: intravenous"
15772358|NCT04676360|Drug|Belantamab Mafodotin|Belantamab mafodotin will be administered intravenously at calculated dose on day 1 of each 21-day cycle.
15772359|NCT04676334|Drug|Rucaparib|Rucaparib will be administered daily.
15772360|NCT04676321|Other|Patient pathway|Investigation on the appropriateness and quality of NSCLC care among participating sites
15772361|NCT04676308|Other|Artificial Intelligence|Artificial intelligence
15772362|NCT04676295|Behavioral|Face-to-face and web-based lifestyle intervention|Families are provided at baseline with one 60 min face-to-face dietary counseling session with nutritionist using family-oriented motivational interviewing and solution focusing techniques. The intervention continues in an interactive web-based portal where different modules include assignments, activities, and tests and related videos targeting five cardiovascular health-linked behaviors: 1) improving quality of fat in the diet, 2) increasing the consumption of foods rich in fiber, 3) decreasing the use of salt, 4) increasing physical activity and 5) reducing smoking.
15772363|NCT04676282|Other|Hypothetical Scenario|Participants will be randomized to one of the arms. Each arm will contain a different hypothetical scenario.
15772364|NCT04676269|Biological|Amnion only|Patients endometrium will be transplanted with amnion only (without seeded cells)
15772365|NCT04676269|Biological|Amnion - endometrium cells|Patients endometrium will be transplanted with amnion seeded with endometrium cells isolated from the patients themselves
15772366|NCT04676269|Biological|Amnion - amnion epithelial cells|Patients endometrium will be transplanted with amnion seeded with amnion epithelial stem cells isolated from other patients' caesarean sectio amnion membrane (tested HLA-DR negative to prevent rejection)
15772367|NCT04676269|Biological|Amnion-EnSC-AESC|Patients endometrium will be transplanted with amnion seeded with endometrium cells-amnion epithelial stem cells co-culture
15772368|NCT04676256|Procedure|Early vitrectomy|Eyes with spontaneous vitreous hemorrhage treated with early vitrectomy (n = 63)
15772369|NCT04676243|Drug|Quizartinib|20 mg coated tablets, orally administered
15772370|NCT04676243|Drug|Treatment according to Physician's Choice|Usually daunorubicin/ cytarabine or idarubicin/Cytarabine plus FLT3 inhibitor (usually midostaurin)
15772371|NCT04676243|Drug|Standard of Care Chemotherapy|Daunorubicin/ Cytarabine or Idarubicin/Cytarabine
15772372|NCT04676230|Procedure|Experimental group|Caries management based on the ICCMSTM: Patient intervention according to the caries risk likelihood: high, moderate or low. Surfaces intervention according to the surface diagnosis decision matrix (ICCMSTM): Mi: Initial caries management, Mm: Moderate caries management, and Me: Extensive caries management.
15772373|NCT04676230|Procedure|Control group|Systematic patient caries risk intervention (all managed as high risk patients). Surfaces intervention with conventional caries management of cavitated/dentin caries lesions (restorative treatment).
15772374|NCT04676217|Procedure|Postoperative positioning advice|The postoperative positioning advice until 3 am the same day.
15772375|NCT04676204|Drug|Cladribine|Cladribine is a purine antimetabolite indicated for the treatment of relapsing forms of multiple sclerosis, to include relapsing-remitting disease and active secondary progressive disease, in adults.
15772376|NCT04676204|Drug|Dimethyl fumarate|Dimethyl fumarate is indicated for the treatment of relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults
15772377|NCT04676204|Drug|Fingolimod|Fingolimod is a sphingosine 1-phosphate receptor modulator indicated for the treatment of patients with relapsing forms of multiple sclerosis to reduce the frequency of clinical exacerbations and to delay the accumulation of physical disability.
15772378|NCT04676204|Drug|Teriflunomide|Teriflunomide is a pyrimidine synthesis inhibitor indicated for the treatment of patients with relapsing forms of multiple sclerosis.
15772379|NCT04676191|Device|Sleepiz One+|Simultaneous sleep study with polysomnography and Sleepiz One+
15772380|NCT04676191|Device|Polysomnography|Simultaneous sleep study with polysomnography and Sleepiz One+
15772381|NCT04676178|Drug|PRA023|PRA023
15772382|NCT04676178|Other|Placebo|Placebo
15772454|NCT04675580|Behavioral|Toy Talk|Language modeling strategy encouraging caregivers to (1) talk about the toys the child is playing with, including the states, actions, and properties of the toys and (2) give the object its name using a lexical noun phrase.
15772383|NCT04676165|Device|Smart About Meds (SAM)|"SAM generates a patient-friendly list of prescribed and dispensed medications and offers several features:
~Drug information: Patient-friendly monographs that describe treatment indications and the harms/benefits of medications.
~Adherence alerts: Alerts users to non-adherence, such as when they fill prescriptions that were stopped at hospital discharge, don't fill prescribed medications, or buy medications at the incorrect dose.
~Side-effect checker: Provides a list of side effects associated with individual medications and the patient's overall drug profile.
~Rate my med: Allows patients to rate medications and describe experiences with a medication. Patients can view ratings given by users.
~Caregiver connect: Provides patients' caregivers with access to the app.
~Pharmacy connect: Allows patients to connect with their hospital pharmacist to ask questions regarding their medications and adherence alerts.
~Other: pill images, daily pill reminders, weekly dosing schedule"
15772384|NCT04676139|Drug|Fluoxetine|Fluoxetine 10 mg capsules once daily for 12 months
15772385|NCT04676139|Drug|Placebo|placebo for 12 months
15772386|NCT04676126|Dietary Supplement|Lumega-Z|Medical food which contains lutein, zeaxanthin, and meso-zeaxanthin
15772387|NCT04676126|Drug|Dorzolamide Hcl 2% Oph Soln|Topical carbonic anhydrase inhibitor
15772388|NCT04676126|Other|Placebo|Specially formulated non macular pigment-containing formulation which tastes similar to the commercial medical food being evaluated in this study
15772389|NCT04676100|Other|Cardiac rehabilitation|"A CR program is defined as one that offers initial assessment, structured exercise (can be supervised or unsupervised) and at least one other strategy to control risk factors. The registry pertains to phase II CR.
~Quality of care and patient outcomes are benchmarked with other countries anonymously, through 2 registry dashboards (real-time). The dashboards will also show change over time in 6-month increments; Sites will be encouraged to continue to provide data on new patients until all indicators show quality as possible.
~Sites will be supported in quality improvement by the ICRR user sub-committee. High-performing programs will be recognized on ICRR's website and ICCPR's social media accounts. This mechanism may be used in future to support program accreditation."
15772390|NCT04676087|Procedure|Extracorporeal Photopheresis|Undergo ECP
15772391|NCT04676087|Biological|Mogamulizumab|Given IV
15772392|NCT04676087|Other|Quality-of-Life Assessment|Ancillary studies
15772393|NCT04676074|Device|Electronic Upper limb( body) ergometer|Electronic pedal for the upper limb using for training the upper body. Intensity, speed and resistance can be adjusted.
15772394|NCT04676061|Drug|Norethindrone acetate (NTA)|norethindrone acetate, 5 mg tablet, orally, once daily for 7 consecutive days, every 4 weeks
15772395|NCT04676061|Drug|Placebo|Placebo, tablet, orally, once daily for 7 consecutive days, every 4 weeks
15772396|NCT04676048|Biological|ASC618|ASC618 will be given as a single IV infusion
15772397|NCT04676035|Drug|Midazolam, Warfarin, Omeprazole, VitaminK1 and SHR3680|"Experimental: Midazolam, Warfarin, Omeprazole, VitaminK1 and SHR3680
~Midazolam, Warfarin, Omeprazole and VitaminK1 QD on Day 1 and Day 22, SHR3680 240 mg once daily (QD) from Study Day 6 - 27"
15772398|NCT04676022|Device|WaveWriter|To receive Spinal Cord Stimulation programming
15772399|NCT04676022|Other|Conventional Medical Managament|To receive conventional medical management
15772400|NCT04676009|Other|Exercise arm :|"Patients will receive physical activity recommendations at inclusion.
~At each treatment cure, patients will receive pre-exercise nutritional recommendations and an acute physical exercise prior to immunotherapy and chemotherapy. The acute physical exercise will last 35 minutes and will be intermittent and individualized based on the results obtained by the patient during an endurance test on a ergocyle performed prior to treatment.
~3 blood sampling times (2 EDTAsx10 mL) will be specially added to the study and will take place before exercise (1), after exercise (2) and 12 hours after the start of treatment (3).
~A nutritional assessment will be carried out during the first and last treatment cure.
~They will also benefit a home walking program. These patients will have to wear an activity tracker tracker during all intervention (3 months).
~They will have a phone follow-up every 10 days (± 3 days) after each treatment cure for the study duration."
15772401|NCT04675996|Drug|INT-1B3|60-min i.v. infusions twice per week in 21-day cycles
15772402|NCT04675983|Drug|Sintilimab|Administered IV
15772403|NCT04675983|Drug|Ramucirumab|Administered IV
15772404|NCT04675983|Drug|Cisplatin|Administered IV
15772405|NCT04675983|Drug|5-fluorouracil|Administered IV
15772406|NCT04675983|Drug|Oxaliplatin|Administered IV
15772407|NCT04675983|Drug|Capecitabine|Administered orally
15772408|NCT04675970|Other|Observational|Product in a Institute of Bio-Stem Cell rehabilitation UAB - sponsored clinical trial who agree to participate in this study
15772409|NCT04675957|Other|cardiac rehabilitation|stationary or ambulatory cardiac rehabilitation
15772410|NCT04675944|Drug|BIA 5-1058|200 mg (2 x 100 mg tablets), oral route
15772411|NCT04675944|Drug|treprostinil|1 mg (1 extended-release tablet), oral route
15772412|NCT04675931|Drug|KAE609|"Two doses of Intravenous Cipargamin will be evaluated in the initial phase of the study (Cohorts 1-2).
~These doses will cover a wider exposure range and facilitate the selection of an appropriate dose for later Cohorts 3-5."
15772413|NCT04675931|Drug|IV Artesunate|Parenteral artesunate is the WHO recommended first line treatment for severe malaria. Hence IV artesunate is used as comparator. Also, this will be used as rescue medication for participants where IV KAE609 is not working.
15772414|NCT04675931|Drug|Coartem|Oral Standard of Care
15772415|NCT04675918|Procedure|Cardiac arrest|Definition of characteristics of cardiac arrest and resuscitation as well as post-resuscitational care and follow up.
15772416|NCT04675905|Other|no intervention (cohort study)|Explanatory variables include preoperative comorbidities, baseline disability, surgical risk, postoperative complications, sex, rural/urban area of residency, Oslo Social Support Scale; Clinical Frailty Scale in patients aged >= 65 years
15772417|NCT04675892|Procedure|A1 pulley division|"Local anesthesia with 5-10 ml of solution required (90 % lidocaine 1 % with 1 ug epinephrine, 10 % sodium bicarbonate 8.4 %).
~Division of the A1 pulley.
~Wound closure with absorbable sutures and application of a light dressing."
15772455|NCT04675567|Behavioral|Safety-Net Care Team Model|"Safety-Net Care Planning Team: Clinical expertise will be combined with peer-to-peer parent/guardian support for trauma-informed care delivery to both parent and child. All aspects of the care continuum will be provided in a culturally and linguistically competent manner, with child and family-driven care planning."
15772418|NCT04675892|Procedure|A1 pulley division + Resection of one or both slips of the FDS tendon|"Local anesthesia with 5-10 ml of solution required (90 % lidocaine 1 % with 1 ug epinephrine, 10 % sodium bicarbonate 8.4 %).
~Division of the A1 pulley.
~Palmar Bruner incision over the PIP joint. Distal dissection and resection of one or both slips of the FDS tendon.
~Wound closure with absorbable sutures and application of a light dressing."
15772419|NCT04675879|Device|Shoulder arm bandage|Three different shoulder-arm bandage types
15772420|NCT04675866|Other|Camrelizumab, Albumin-bound paclitaxel, S-1|Camrelizumab: 200mg, iv, Q3W, d1; Albumin-bound paclitaxel: 125mg/m2, iv, d1, 8, Q3W; S-1: According to the patient's body surface area, the dosage is set to 40, 50, 60 mg/time, bid, po, taking 2 weeks, and stopping the drug for 1 week as a cycle.
15772421|NCT04675840|Procedure|Robotic-assisted hysterectomy|Robotic-assisted surgery
15772422|NCT04675827|Drug|Pertuzumab and tratuzumab fixed dose combination|Treatment administration: adjuvant pertuzumab and trastuzumab fixed dose combination SC for 14 cycles
15772423|NCT04675827|Drug|Trastuzumab emtansine|Treatment administration: adjuvant T-DM1 for 14 cycles.
15772424|NCT04675814|Other|Adapted Physical Activity (APA)|Adapted Physical Activity (APA)
15772429|NCT04675775|Other|Medically-tailored meals (MTM)|After the run-in baseline period participants will be expected to consume the meals and protein supplements meals between approximately Weeks 4 - 11 of the study. Additionally, participants will complete surveys before, during and after the meals.
15772430|NCT04675775|Dietary Supplement|Protein supplements|"A daytime and nighttime protein supplement will be provided after the baseline visit and should be consumed daily at home during the same study days as MTM. The daytime protein supplement is a protein bar (ZonePerfect or Perfect Bar). The nighttime supplement is a protein powder or liquid that can be dissolved in either water or milk.
~This is provided to participants with ProCel Vanilla Whey Protein powder which provides 15 grams of protein per serving or the ProCel LiquaCel liquid protein supplement mango, grape, watermelon and/or lemon flavors which provides 16g of protein per serving."
15772431|NCT04675775|Behavioral|Nutrition education handout|A standardized nutrition education handout containing instructions on following a high-protein and sodium restricted diet (depending on the presence of ascites) will be given as part of Standard of Care.
15772432|NCT04675762|Drug|Fingolimod|Patients randomized to fingolimod will also receive fingolimod (Gilenya, Novartis) at a dosage of 0.5 mg once daily, for three consecutive days, with the first dose being given at the time in which patients are enrolled which is about one hour prior to mechanical thrombectomy.
15772433|NCT04675762|Other|Placebo|Patients randomized to fingolimod will also receive placebo once daily, for three consecutive days, with the first dose being given at the time in which patients are enrolled which is about one hour prior to mechanical thrombectomy.
15772434|NCT04675736|Procedure|brushing force|Using duplication method, vertical force was applied from 1-5.5 N in linear mesial-distal brushing motion at 4 strokes per second for 5 seconds Force was increase 0.5 N in every testing until plaque was completely removed from enamel surface
15772435|NCT04675710|Procedure|Conventional Surgery|Undergo surgery
15772436|NCT04675710|Drug|Dabrafenib|Given PO
15772437|NCT04675710|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
15772438|NCT04675710|Biological|Pembrolizumab|Given IV
15772439|NCT04675710|Other|Quality-of-Life Assessment|Ancillary studies
15772440|NCT04675710|Drug|Trametinib|Given PO
15772441|NCT04675697|Drug|Platinum-etoposide+Anlotinib|Platinum-etoposide regiment consisted of etoposide 100mg/m2, d1~3 of 21-day cycle, with investigators' choice of either cisplatin (75-80mg/m2, Q3W) or carboplatin (AUC=5~6, Q3W). Anlotinib treated of 12mg Qd from day 1 to 14 of a 21-day cycle. Eligible patients received anlotinib plus platinum-etoposide for 4~6 cycles, and followed by maintenance therapy with Anlotinib. The efficacy was evaluated every 6 weeks (2 cycles) through treatment.
15772442|NCT04675684|Behavioral|Recovery-group|The complex intervention are instructions in ruminations-therapy and mindfulness, advice in healthy diets, physical - and social activities and sleep hygiene, and support in smoking cessation, alcohol counseling and medication adherence.
15772443|NCT04675671|Other|Preoperative and postoperative anxiety measurement [Spielberger's State Anxiety Scale (STAI-S)] and [ Spielberg's State-Trait Anxiety Inventory (STAI-T) ]|The postoperative pain is measured and evaluated by Visual Analog Scale (VAS= 0 = no pain to 10 = worst pain)
15772444|NCT04675658|Behavioral|CBPA + family support|Classroom Based Physical Activity + family support as described in the Arm
15772445|NCT04675658|Behavioral|CBPA|Classroom Based Physical Activity
15772446|NCT04675645|Other|HU-Go app|A novel multifunctional mobile app (HU-Go) to improve adherence to hydroxyurea in patients with sickle cell disease
15772447|NCT04675632|Procedure|Endovascular Therapy|the most commonly used surgical options include: ordinary balloon dilatation， drug-coated balloon (DCB) dilatation and bare stent implantation.
15772448|NCT04675619|Drug|Oral pirfenidone|Treatment
15772449|NCT04675619|Drug|Standard care|Treatment
15772450|NCT04675606|Behavioral|Regular diet|Patients in the regular diet arm (which is the experimental arm) will not have any diet limitations and will be recommended to consume a healthy balanced diet for American adults as recommended by the United States Department of Agriculture (USDA) and US Food and Drug Administration (FDA).
15772451|NCT04675606|Behavioral|Low fiber diet|Patients in the low fiber diet arm (which is the control arm) will be recommended to consume foods that are low in fiber content per United Ostomy Associations of America Recommendations
15772452|NCT04675593|Behavioral|iTAB-CV|Individualized Texting for Adherence Building - Cardiovascular (iTAB-CV): a personalized patient-centered text message-based adherence intervention
15772453|NCT04675593|Behavioral|Self-Monitoring|The Self-Monitoring (control) group will monitor their medication adherence, take their blood pressure weekly with a home blood pressure monitor provided by the study after being trained by the study staff, and rate their mood weekly in response to a text reminder.
15839760|NCT04126200|Drug|Nirogacestat|Nirogacestat will be administered
15772456|NCT04675554|Other|Follow up of physical activity|participants will fill in the non-opposition form via the application and will complete, with their smartphone, a series of psychometric questionnaires. Participants will then use the mobile application for a period of 12 weeks during which time, physical activity data provided from participants smartphone will be gathered After 12 weeks, participants will complete again the same series of psychometric questionnaires.
15772457|NCT04675541|Biological|Afstyla®|Solution for injection
15772458|NCT04675528|Drug|DHP107(Oral paclitaxel)|DHP107 200 mg/m2 orally twice daily on Days 1, 8, and 15 in every 28 days (On food effect study day, DHP107 200 mg/m2 orally once daily on Days 1, 8 of Cycle 1 with fasted or fed condition according to the assigned sequence)
15772459|NCT04675515|Behavioral|Intensive Tobacco Treatment|Bi-weekly tobacco treatment counseling and regular carbon monoxide monitoring
15772460|NCT04675502|Other|supervised Exercise training|warm-up, loading (respiratory control training, breathing exercises, posture exercises with respiratory control , walking on the treadmill for 20 minutes without inclination , pedaling in the bicycle ergometer for 10 minutes), cooling, and relaxation exercises
15772461|NCT04675502|Other|home exercise trainig|Warm-up, loading (respiratory control training, shrunken lip breathing exhaustion, diaphragmatic, thoracic expansion exercises, posture exercises with respiratory control (pectoral stretching, four-way trunk exercises, head and neck exercises, bilateral shoulder flexion and abduction exercises), cooling and relaxation exercises
15772462|NCT04675489|Other|Procedure: Vivity Toric IOL|The U.S. Food and Drug Administration (FDA) has granted approval of Alcon's Vivity Toric Extended Vision intraocular lens (IOL) for cataract patients. This innovative lens is an extended depth of focus IOL that has been reported to result in fewer visual disturbances than diffractive IOLs.
15772463|NCT04675476|Behavioral|Provider Prompt & Patient Outreach and Education|To target lack of provider-prompted discussion about lung screening, an electronic medical record (EMR) message will be sent to primary care providers prior to scheduled visits with screening-eligible patients to notify them of the patient's eligibility and to encourage discussion of the benefits and limitations of the test. To target patient-level knowledge about lung screening, an outreach specialist will educate screening-eligible patients about the benefits and limitations of the test prior to their visit.
15772464|NCT04675463|Drug|BGF Inhalation Aerosphere|Budesonide/Glycopyrronium/Formoterol: 160/7.2/4.8/ puff, twice daily with two puffs per time
15772465|NCT04675463|Drug|GFF Inhalation Aerosphere|Glycopyrronium/Formoterol: 7.2/4.8 per puff, twice daily with two puffs per time
15772466|NCT04675450|Drug|Placebo|Take 4 capsules BID on an empty stomach at least 1 hour before food intake, and remain fasting at least 1 hour after dosing
15772467|NCT04675450|Drug|NBP Softgel Capsules|Take 4 capsules BID on an empty stomach at least 1 hour before food intake, and remain fasting at least 1 hour after dosing.
15772468|NCT04675437|Other|Aerobic exercise|12-weeks aerobic exercise program
15772469|NCT04675424|Device|ANSwatch|"ANSwatch wrist sphygmomanometer and the specific database from monitors in ICUs may be a feasible way to predict outcome among ICU patients. Two measurements will be obtained:
~Pulse diagnosis: Pulse diagnosis done on radial artery is recorded by traditional Chinese medicine physician and ANSwatch wrist sphygmomanometer at the same time.
~Heart rate variability: Heart Rate Variability represents significant information on autonomic nervous system (ANS)'s regulating function and balance status."
15772470|NCT04675411|Device|Smart care|Home based nursing intervention with smart assisted technology
15772471|NCT04675411|Device|usual care|Routine hospital care with only in-hospital rehabilitation
15772472|NCT04675398|Device|Summit RC+S|Using the RC+S pulse generator, patients receive clinically-optimized open loop DBS stimulation to the pallidum.
15772473|NCT04675398|Device|Summit RC+S|Using the RC+S pulse generator, the patients will receive closed-loop stimulation at random time points. These random stimulation times will in total equal the total amount of time of active movement.
15772474|NCT04675398|Device|Summit RC+S|Using the RC+S pulse generator, the patients will receive closed-loop stimulation during time of contralateral limb movement (e.g. left brain stimulation during right leg/arm movement).
15772475|NCT04675398|Device|Summit RC+S|Using the RC+S pulse generator, the patients will receive closed-loop stimulation during time of no movement for the contralateral limb (e.g. left brain stimulation while right leg/arm is not moving).
15772476|NCT04675385|Drug|0.2% hyaluronic acid gel|In this split mouth study, 733 periodontal pockets of 28 patients with moderate to severe chronic periodontitis were chosen for investigation. They were divided into 2 groups: control group and experimental group. The experimental group received sub-gingival administration of 1 ml of 0.2% hyaluronic acid gel into each pocket immediately after root planing and then after 1 week, 2 weeks and 3 weeks. Clinical parameters were assessed at baseline and 6 weeks after root planing. Subgingival plaque was assessed at baseline and 6 weeks after root planing. Quantitative real-time PCR for Porphyromonas gingivalis (Pg), Treponema denticola (Td), Fusobacterium nucleatum (Fn) Tannerella forsythia (Tf) were performed at the same time.
15772477|NCT04675372|Drug|Dexmedetomidine|Dexmedetomidine group (Group D) was given 1.5ug/kg/h Dexmedetomidine continuous infusion
15772478|NCT04675372|Drug|Midazolam|Midazolam group (Group M) was continuously pumped with 0.05mg/kg/h midazolam
15772479|NCT04675359|Procedure|Autologous adipose derived Mesenchymal Stromal Cells (MSC) injection into the knee joint|Injections of the two adipose tissue derived products containing MSCs into the knee joints with osteoarthritis
15772480|NCT04675346|Other|Questionnaire|Questionnaire
15772481|NCT04675333|Drug|Evorpacept|IV Q3W
15772482|NCT04675333|Drug|Pembrolizumab|IV Q3W
15772483|NCT04675333|Drug|Cisplatin/Carboplatin; 5FU|IV Q3W
15772484|NCT04675320|Other|blood sample|Olaparib
15772485|NCT04675320|Other|blood sample|Niraparib or Olaparib
15772486|NCT04675294|Drug|Evorpacept|IV Q3W
15772487|NCT04675294|Drug|Pembrolizumab|IV Q3W
15772510|NCT04675086|Drug|Antiviral Agents|a SARS-CoV-2 nucleotide analog RNA polymerase inhibitor indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of coronavirus disease 2019 (COVID-19) requiring hospitalization
15772571|NCT04674670|Drug|Placebo|In substudy 2, healthy controls and fibromyalgia patients will be administered a placebo as for comparison with the effects of bromocriptine (healthy controls and patients) and amisulpride (healthy controls only) on fronto-striatal functional connectivity in relation to emotional-motivational pain processing.
15772488|NCT04675281|Other|2 post-mortem transcutaneous lung biopsies (1 anterior ; 1 posterior) using anatomical landmarks|All specimens are fixed with 4% neutral formaldehyde and embedded in paraffin wax in the department of pathology of each participating centre. Afterwards, all samples are sent for analysis to the department of pathology of Nantes university hospital. All biopsies are independently analysed by a group of pathologists who are experts in lung tissue and blinded to clinical information. All biopsies will be analysed using a predetermined semi-quantitative histological scoring grid. The pathologists are asked to assess the degree of: edema, cell necrosis, hyaline membrane formation, proliferation of alveolar type 2 cells, fibrosis, capillary congestion, alveolar edema, neutrophilic infiltration, and microscopic thrombosis. Finally, the following patterns are recorded: exudative diffuse alveolar damage (DAD), proliferative DAD, fibrosis, intra-alveolar haemorrhage, lymphocytic pneumonia, organizing pneumonia, acute fibrinous organizing pneumonia (AFOP), thrombotic microangiopathy.
15772489|NCT04675268|Diagnostic Test|oximetry|A CE medical approved polygraphy device (Dreamscan 2 - Medatec) will be used to obtain oximetry (and PPG) data
15772490|NCT04675255|Procedure|Frequently sampled glucose tolerance testing|Frequently sampled glucose tolerance testing
15772491|NCT04675255|Procedure|abdominal subcutaneous adipose tissue biopsy|abdominal subcutaneous adipose tissue biopsy
15772492|NCT04675255|Procedure|MRI scan to assess intrahepatic triglyceride content|MRI scan to assess intrahepatic triglyceride content
15772493|NCT04675242|Drug|NCX 4251|NCX 4251 Ophthalmic Suspension, 0.1% dosed once daily
15772494|NCT04675242|Drug|Placebo|Vehicle of NCX 4251 Ophthalmic Suspension dosed once daily
15772495|NCT04675216|Procedure|Posterior fossa intracranial pressure measurement|Measurement of posterior fossa pressure in an invasive way
15772496|NCT04675203|Procedure|Tooth extraction|Tooth extraction
15772497|NCT04675190|Procedure|Major abdominal Surgery|Any surgery performed under general or regional anesthesia and procedures involving abdominal cavity is considered major abdominal surgery and those who have undergone any major abdominal surgery before 6 months from the date of ultrasound findings confirming the presence or absence of gall stone will be considered exposed.
15772498|NCT04675177|Drug|Polidocanol foam sclerotherapy|"i. Patients underwent preparation, two hours before the intervention, with cleaning enema (Disodium phosphate). No antibiotic prophylaxis was prescribed.
~ii. Preparation of the polidocanol (Aethoxysklerol 3%) foam according to Tessari technique immediately before application, so that the microbubbles of the foam did not disintegrate; iii. The procedure was performed in the medical office. Application according to the Blanchard technique through a disposable transparent anoscope, in jackknife position, using a 20mL disposable syringe of the mixture (polidocanol + air) and a reusable 10 cm syringe extender adapted to an intravenous needle; iv. Patients were treated in a maximum of 3 sessions, at 3 weeks intervals; v. Maximum dose per treatment session of 20mL of mixture of 4mL of polidocanol 3% with 16mL of air; i. In each session, the sclerosant was injected in one or more hemorroidary cushion;"
15772499|NCT04675177|Procedure|Doppler-guided hemorrhoidal artery ligation|"i. Patients underwent preparation with cleaning enema (Disodium phosphate). No antibiotic prophylaxis was prescribed.
~ii. The procedure was performed in the operating room of an outpatient surgery unit, under regional anestesia.
~iii. A proctoscope with a Doppler transducer in its tip was introduced inside the anal canal to search for the superior rectal artery.
~iv. Each branch was ligated with suture above the dentate line. The device was rotated slowly in clockwise direction to locate further arteries at that level.
~v. Rectoanal repair consisted in a continuous running suture was applied longitudinally just over every prolapsed hemorrhoid."
15772500|NCT04675164|Device|Laser Assisted Immotile Sperm Selection|LAISS will be performed using diode laser system at the lowest working power with a single laser shot at the lower one third of the sperm tail. If sperm tail curling occurred, the sperm is then viable and will be utilized for ICSI after immobilization in PVP.
15772501|NCT04675164|Procedure|Hypo-osmotic Swelling Test|HOST will be performed by transferring immotile sperms from incubation droplet into HOST droplet, with any sperm showing tail swelling will be identified as viable and will be utilized for ICSI after immediate transfer and immobilization.
15772502|NCT04675151|Drug|Phentolamine Ophthalmic Solution 0.75%|0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
15772503|NCT04675151|Drug|Pilocarpine|Pilocarpine ophthalmic solution
15772504|NCT04675151|Other|Placebo|Topical sterile ophthalmic solution
15772505|NCT04675138|Other|No intervention will be provided to the subject|No intervention will be provided to the subject
15772506|NCT04675112|Behavioral|Cognitive Behavioral Treatment (CBT) and Tinnitus Retraining Therapy (TRT)|"CBT is a psychologically informed treatment. Depending on individual patient needs, relevant areas of tinnitus education and management/self-management strategies, such as managing the emotional consequences of tinnitus, rapid relaxation, managing fear and avoidance behaviors and changing unhelpful thoughts and beliefs, are applied in accordance to a published manual [10].
~TRT is based on the neurophysiological model focusing more on education and sound therapy than on analytical cognitive and behavioral interventions. A TRT program is usually included in a management scheme with hearing aids."
15772507|NCT04675099|Behavioral|pCARE|"Mothering from the Inside Out is an evidence-based intervention delivered in substance use treatment settings that helps mothers with substance use disorders foster parent-child attachment, cope with stressful parenting situations, and promote their child's healthy development. This 3 month counseling intervention both improves parent-child attachment and decreases rates of drug relapse among mothers. The proposed mechanism of action targeted by the intervention is a change in parental reflective functioning, defined as the capacity to recognize and make sense of mental states (especially emotional states) and understand how they influence behavior and relationships."
15772508|NCT04675099|Other|Standard Early Intervention services|The state of Massachusetts provides voluntary early childhood development services to substance-exposed infants through a system of Early Intervention programs. These programs offer coordinated services to all infants and toddlers with disabilities and those at risk for developmental delays in homes and child centers beginning at birth.
15772509|NCT04675086|Drug|alpha1-proteinase inhibitor|Alpha1-Proteinase Inhibitor (Human), AralastÔ, is a sterile, stable, lyophilized preparation of purified human alpha1-proteinase inhibitor (a1-PI), also known as alpha1-antitrypsin.
15772572|NCT04674657|Drug|blood drug concentration|blood drug concentration
15772575|NCT04674618|Device|US-assisted nusinersen administration|Ultrasound identification of intervertebral space (L2-L3 or L3-L4)
15772511|NCT04675073|Procedure|Ventricular tachycardia substrate-based radiofrequency ablation|The CARTO3 electroanatomic navigation system (Biosense Webster, Diamond Bar, CA, USA) will be used for ablation. An open irrigated 3.5-mm tip ablation catheter (ThermoCool SmartTouch, Biosense Webster, Diamond Bar, CA, USA) will be used for mapping and ablation. The first step of the procedure will be the acquisition of a fast-anatomical map (FAM) of the aorta. This FAM will be then used to integrate the multi-detector cardiac tomography (MDCT) reconstruction and cardiac magnetic resonance (CMR)-derived pixel-signal intensity (PSI) maps within the spatial reference coordinates of the CARTO3 system. RF will be delivered at the entrance of the border zone channels (BZCs) identified in the PSI maps (CMR-guided scar dechanneling technique). Programmed ventricular stimulation (PVS) will be always performed after substrate elimination to test for final inducibility.
15772512|NCT04675060|Drug|TQ-B3139 capsules|TQ-B3139 capsules administered 600mg orally, twice daily in 28-day cycle.
15772513|NCT04675047|Other|no intervention for healthy control|observational study - no intervention
15772514|NCT04675034|Biological|MEDI7352|Dose A: MEDI7352 Q2W
15772515|NCT04675034|Biological|MEDI7352|Dose B: MEDI7352 Q2W
15772516|NCT04675034|Biological|MEDI7352|Dose C: MEDI7352 Q2W
15772517|NCT04675034|Biological|MEDI7352|Dose D: MEDI7352 Q2W
15772518|NCT04675034|Biological|Placebo|Placebo to match MEDI7352 Q2W
15772519|NCT04675021|Drug|AZD6094 (Savolitinib) film coated tablets 600 mg|AZD6094 (Savolitinib) ilm Coated Tablet 200 mg x 3
15772520|NCT04675021|Drug|[14C]-AZD6094 (Savolitinib) Solution for Infusion, 20 μg/mL (NMT 37.0 kBq/5 mL)|14C AZD6094 (Savolitinib) Solution for Infusion (20 μg/mL (NMT 37.0 kBq/5 mL)
15772521|NCT04675021|Drug|[14C] AZD6094 (Savolitinib) Oral Solution, 300 mg (NMT 4.1 MBq)|14CAZD6094 (Savolitinib) Oral Solution (300 mg NMT 4.1MBq)
15772522|NCT04675008|Drug|Dacomitinib|Secondary generation EGFR-tyrosine kinase inhibitor (TKI) (Dacomitinib) for EGFR mutant NSCLC patients with non irradiated brain metastasis
15772523|NCT04674995|Procedure|Stent placement|All interventional procedures have been performed in the operating room with a Dumon rigid bronchoscope under general anesthesia. Neodymium-doped yttrium aluminium garnet laser photoresection was performed at 15-30 watts and pulse duration of 0.5-1.0s whenever indicated. A silicone stent was placed.
15772524|NCT04674982|Device|a vibrating device|vibrating device (Mini vibrator, 8.5 cm, 92-100 Hz)
15772525|NCT04674969|Device|Any eligible commercially available Boston Scientific Corporation (BSC) drug-eluting device.|Ranger™ Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; ELUVIA™ Drug-Eluting Vascular Stent System
15772526|NCT04674956|Drug|Camrelizumab|PD-1 antibody（Camrelizumab）, 200mg, D1; every 21 days as a cycle.
15772527|NCT04674956|Drug|Paclitaxel(Albumin Bound) and Gemcitabine|Paclitaxel(Albumin Bound), 125 mg/m2D18; Gemcitabine, 1000mg/m2D1, 8;every 21 days as a cycle.
15772528|NCT04674956|Drug|Placebo|Placebo, 200mg, D1; every 21 days as a cycle.
15772529|NCT04674943|Other|Breathing exercises|Breathing exercises as well as Buteyko technique and Papworth relaxation method was performed as relaxation technique. All exercises were performed 15rep 3 sets for 15 min.
15772530|NCT04674930|Other|Exercise program|Home based exercise program including aerobic and resistance training will be carried out for a period of 6 weeks. Duration of aerobic exercise will be starting at 20 min/session, and progress to 30 ruin/session, with an increased pace according to the patient's capabilities. Resistance training with thera-band for 1 set of 10 repetitions twice a week. One RM will be reassessed weekly, and the program will be adjusted accordingly.
15772531|NCT04674917|Other|Decompression + Hot pack, TENS, Mobilization, Exercise Therapy|"Group A which includes the acute group to study the effects of decompression we will apply the three main basic treatments along with decompression which is our main goal..
~The basic treatments are
~Hot Pack
~TENSE
~Mobilization ( on lumbar L1 toL5 ) Our first modality which is hot pack will be given to the patients for a duration of 15 minutes The next modality TENSE will be given for 10 minutes
~The third treatment which is mobilization will be given 1 time on each joint of lumbar spine All these treatments must given in combination with the decompression."
15772532|NCT04674917|Other|Decompression + Hot pack , TENS , Mobilization , Exercise Therapy|"Group B which includes the chronic group to study the effects of decompression we will apply the three main basic treatments along with decompression which is our main goal..
~The basic treatments are
~Hot Pack
~TENSE
~Mobilization ( on lumbar L1 toL5 )
~Our first modality which is hot pack will be given to the patients for a duration of 15 minutes The next modality TENSE will be given for 10 minutes
~The third treatment which is mobilization will be given 1 time on each joint of lumbar spine All these treatments must given in combination with the decompression."
15772533|NCT04674917|Other|Hot pack , TENS, Mobilization, Exercise therapy|"Group C which is our control group to compare it with the groups A and B to study the effects of decompression on lumbar radiculopathy The basic treatments are
~Hot Pack
~TENSE
~Mobilization ( on lumbar L1 toL5 )
~Our first modality which is hot pack will be given to the patients for a duration of 15 minutes The next modality TENSE will be given for 10 minutes
~The third treatment which is mobilization will be given 1 time on each joint of lumbar spine It is kept in mind that in this group we will not apply the decompression along with the above treatments."
15772534|NCT04674904|Other|Dry Needling|Dry needling on Upper trapezius, Levator Scapulae, Sternocledomastoid , Pectorals major and minor and rhomboids for 10 min
15772535|NCT04674904|Other|Hot pack , TENS , Stretching|"Treatments are
~Hot Pack for 15 minutes
~TENS for 10 minutes
~Stretching
~The third treatment which is Stretching will be given one time on each muscle (tight upper trap, Levator Scapulae, Sternocledomastoid , Pectorals major and minor and rhomboids) of upper spine"
15772536|NCT04674891|Other|baseline physical therapy treatment|Group A was control group and the patients received Conventional treatment protocol for 4 weeks which included 3 sessions per week. Patients received hot pack for 15 min and TENS (Transcutaneous Electric Nerve Stimulation) for 10 min. After that Cervical isometric exercises will be performed in sitting (10sec hold,10 to 15 reps)
15772570|NCT04674670|Drug|Amisulpride 400 MG|In substudy 2, healthy controls will be administered a single dose of amisulpride (400mg, p.o.) to investigate the effect of transiently decreasing the availability of dopamine on fronto-striatal functional connectivity in relation to emotional-motivational pain processing.
15772573|NCT04674644|Behavioral|The psychosocial effects of COVID-19 pandemic on dental professionals|Analysing the psychosocial effects of COVID-19 pandemic on dental professionals using the Turkish version of the Fear of COVID-19 and Coronavirus Anxiety Scales
15772537|NCT04674891|Other|Cervical Stabilization exercises|"Group B was experimental group and received baseline physiotherapy treatment in addition to Cervical Stabilization exercises. Pillow was placed beneath cervical spine in supine position and guided patients to nod head as though they said 'yes' and asked them to hold for 10 seconds. 10 repetitions were done before progressing to the next target level.
~4 weeks (3 sessions per week)
~Hot pack: 10 min
~TENS: 10 min
~Cervical isometric exercises in sitting (10sec hold,10 to 15 reps)
~Cervical Stabilization exercises (10 sec hold, 10 reps)
~On eligible participants baseline assessment was taken on day 1, post intervention assessment was taken at the end of 4th week."
15772538|NCT04674878|Other|METs|The isometric contraction of 7 sec will be applied followed by a stretching of 30 sec in painless range. This treatment will be given to the both sides of the neck targeting the three major accessory muscles of respiration.
15772539|NCT04674878|Other|Breathing exercise group|Three exercises will be performed in a circuit, 2 circuits in every session. It will include diaphragmatic breathing exercise in which patient will be in supine position inhaling through nose and expiration through moth with half closed lips. Second exercise pursed lip breathing also in supine position with the hands on abdomen and then inspiration through nose and expiration through mouth with half closing of lips. Third exercise resisted diaphragmatic breathing also in same pattern as second exercise with an addition of 1 kg weight on abdomen.
15772540|NCT04674865|Other|Standardized Physical therapy protocol|Standardized Phase 1 protocol without for 7 days without ANB sessions.
15772541|NCT04674865|Other|Alternate nostrils breathing|Alternate nostrils breathing 2 sessions per day
15772542|NCT04674852|Device|Research Marker|The research marker is a cylindrical-shaped marker made of an FDA-approved material that can be seen by ultrasound.
15772543|NCT04674839|Drug|MS-20|fermented soymilk product
15772544|NCT04674839|Other|Placebo|No active ingredient
15772545|NCT04674826|Drug|Tralokinumab administered as 1 × X mL with Device A|Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous (SC) administration
15772546|NCT04674826|Device|Tralokinumab administered as 2 × Y mL with Device B|Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous (SC) administration
15772547|NCT04674813|Drug|CC-95266|IV
15772548|NCT04674813|Drug|Fludarabine|IV
15772549|NCT04674813|Drug|Cyclophosphamide|IV
15772550|NCT04674800|Biological|MYL-1701P, a proposed biosimilar to Eylea|Open label and single arm
15772551|NCT04674787|Other|Peripheral nerve stimulation provocation study|Study which measures stimulation thresholds in volunteers induced by low frequency electromagnetic gradients used in MRI scanners.
15772552|NCT04674774|Drug|Tegoprazan|oral administration of tegoprazan-based bismuth quadruple therapy(tegoprazan 50 mg b.i.d, bismuth 300 mg q.i.d, metronidazole 500 mg t.i.d, tetracycline 500 mg q.i.d) for 14 days
15772553|NCT04674774|Drug|Lansoprazole|oral administration of PPI-based bismuth quadruple therapy(lansoprazole 30 mg b.i.d, bismuth 300 mg q.i.d, metronidazole 500 mg t.i.d, tetracycline 500 mg q.i.d) for 14 day
15772554|NCT04674761|Drug|Odevixibat|Odevixibat is a small molecule and selective inhibitor of IBAT.
15772555|NCT04674761|Drug|Placebo|Placebo identical in appearance to experimental drug (odevixibat).
15772556|NCT04674748|Drug|INCB086550|Each Participant will be treated at the specified dose level with a minimum of 3 subjects at each dose level. After the RP2D of INCB086550 is identified, the dose level will be expanded to better characterize the safety and tolerability and PK.
15772557|NCT04674735|Drug|APSLXR|Oral coated tablets once a day for 60 days.
15772558|NCT04674722|Drug|Injection of 99mTc-NM-02|A Patient will be injected with microdose (<100ug) of 99mTc-NM-02 radiotracer
15772559|NCT04674722|Drug|Injection of 188Re-NM-02|A Patient will be injected with microdose (<100ug) of 188Re-NM-02 radionuclide therapy
15772560|NCT04674709|Drug|Oleander 4X - single|Cohort 1 receive 4 doses of Oleander 4X in a 24-hour period for a period of seven days.
15772561|NCT04674709|Drug|Oleander 4X - double|Cohort 2 receive 2 doses of either active drug or placebo 4 times per day in a 24-hour period for a period of seven days.
15772562|NCT04674709|Drug|Oleander 4X - quadruple|Cohort 3 receive 4 doses of either active drug four times per day in a 24-hour period for a period of seven days.
15772563|NCT04674709|Drug|Placebo|The placebo group receives 4 doses of placebo in a 24-hour period for a period of 7 days
15772564|NCT04674696|Other|Approach|Patients will receive 2 CAPOX cycles, followed by short-course radiotherapy and 4 CAPOX cycles.
15772565|NCT04674683|Drug|HBI-8000 in combination with nivolumab|Patients will take 30 mg of HBI-8000 orally approximately 30 minutes after the first full meal of the day, beginning on Day 1 and continue every 3 to 4 days on the BIW schedule. On Day 1 of each cycle nivolumab 480 mg IV will be administered by intravenous infusion in accordance with OPDIVO® manufacturer regional product information insert and the institution's prescribing practice. In adolescent patients with body weight < 40 kg, nivolumab will be dosed at 6 mg/kg Q4W.
15772566|NCT04674683|Drug|Placebo in combination with nivolumab|Patients will take 30 mg of Placebo orally approximately 30 minutes after the first full meal of the day, beginning on Day 1 and continue every 3 to 4 days on the BIW schedule. On Day 1 of each cycle nivolumab 480 mg IV will be administered by intravenous infusion in accordance with OPDIVO® manufacturer regional product information insert and the institution's prescribing practice. In adolescent patients with body weight < 40 kg, nivolumab will be dosed at 6 mg/kg Q4W.
15772567|NCT04674670|Drug|Low dose naltrexone|Low dose naltrexone will not be utilized here as therapeutic clinical interventions, but to assess psychobiological mechanisms in pain processing. Participants will receive low dose naltrexone with 4.5 mg p.o. daily over a period of 12 weeks.
15772568|NCT04674670|Drug|Placebo|Placebo will be give daily (p.o.) over a period of 12 weeks.
15772569|NCT04674670|Drug|Bromocriptine Mesylate Capsules|In substudy 2, healthy controls and fibromyalgia patients will be administered a single dose of bromocriptine (1.25mg, p.o.) to investigate the effect of transiently increasing the availability of dopamine on fronto-striatal functional connectivity in relation to emotional-motivational pain processing.
15772574|NCT04674631|Other|The effect of neuropathic pain on quality of life, depression and sleep quality|The effect of neuropathic pain on quality of life, depression and sleep quality
15772577|NCT04674592|Other|Blood samples and biopsies|Blood samples for analysis of biomarkers of muscle damage. Muscle biopsies for histological analysis of muscle damage.
15772578|NCT04674579|Device|MRI|magnetic resonance imaging
15772579|NCT04674566|Drug|COR-101|Administered intravenously (IV) single dose
15772580|NCT04674566|Drug|Placebo|Administered intravenously (IV) single dose
15772581|NCT04674540|Other|No Intervention|No Intervention
15772582|NCT04674527|Drug|Elemene|Elemene injectable emulsion will be given for 80 mg/day in each 14-day cycle.
15772583|NCT04674527|Drug|Temozolomide|Maintenance chemotherapy with TMZ will be administered at 150 mg/m2/day for 5 days in each 28-day cycle.
15772584|NCT04674514|Drug|APG-2575|APG-2575 orally once daily, every 28 days as a cycle.
15772585|NCT04674514|Drug|Rd|Lenalidomide administered at a dose of 25 mg orally (PO) on Days 1 through 21 of each 28-day cycle, dexamethasone administered at a dose of 40 mg (or 20 mg for patients>75 years old) on Days 1, 8, 15, and 22 of a repeated 28-day cycle.
15772586|NCT04674501|Procedure|Cardiac evaluation and blood sampling|"Patients in this cohort will undergo cardiac evaluation before and after thoracic irradiation.
~The dose-volume parameters for each cardiac substructures will be estimated using artificial intelligence-based auto-segmentation of the heart in CT images. Dose-volume parameters that predict cardiotoxicity will be analyzed.
~The patients who developed cardiotoxicity will undergo blood sampling to establish cardiomyocytes derived from induced pluripotent stem cells, which will be used for identifying the mechanisms of radiation-induced cardiotoxicity and therapeutic targets."
15772587|NCT04674488|Biological|TILs|a single center, single-arm, open label, interventional study
15772588|NCT04674475|Device|Pressure guidewire, optimal coherence tomography|Pressure guidewire, optimal coherence tomography
15772589|NCT04674462|Biological|CpG-adjuvanted HBV Vaccine|Subjects receiving CpG-adjuvanted HBV vaccine will require two doses at 0 and 1 month after initiation. The second dose will be considered the same as the one month time point following the first dose.
15772590|NCT04674462|Biological|Traditional HBV Vaccine|Subjects receiving traditional HBV vaccine series will require three doses at 0, 1, and 6 months after initiation. The second dose will be considered the same as the one month time point following the first dose.
15772591|NCT04674449|Diagnostic Test|Disclosure of IDP results|The results of the adjunctive IDP performed at time of invasive coronary angiography are made available to the catheter laboratory clinician, to aid in the diagnostic process.
15772592|NCT04674449|Other|IDP performed but results not disclosed|The results of the IDP performed at the time of invasive coronary angiography are concealed from the catheter laboratory clinician who will be blinded. The patient is managed according to standard of care.
15772593|NCT04674436|Behavioral|Walking|6 minute casual walk
15772594|NCT04674423|Drug|Tenofovir Alafenamide|Tenofovir Alafenamide treatment for 144 weeks
15772595|NCT04674410|Drug|Antibiotic|Empiric antibiotic therapy, subdivided according to Community Acquired Pneumonia coverage vs Hospital Acquired Pneumonia coverage
15772596|NCT04674397|Radiation|Radioisotope GFR test|
15772597|NCT04674384|Dietary Supplement|Optifast meal replacement shakes|Optifast® is provided as 53g sachet. Each sachet replaces one meal. It is available in 5 flavours: vanilla, strawberry, chocolate and coffee shakes and vegetable soup.
15772598|NCT04674371|Other|central venous catheter insertion|Every operator should perform the CVC Insertion Procedure according to his common clinical practice.
15772599|NCT04674358|Drug|Reproxalap Ophthalmic Solution (0.25%)|Reproxalap Ophthalmic Solution (0.25%) administered over two consecutive days (Day one pre-dry eye chamber and Day two dry eye chamber assessment).
15772600|NCT04674358|Drug|Vehicle Opthalmic Solution|Vehicle Ophthalmic Solution administered over two consecutive days (Day one pre-dry eye chamber and Day two dry eye chamber assessment).
15772601|NCT04674345|Drug|Sorafenib|The initial dose of sorafenib is 400 mg orally twice daily and is adjusted in case of suspected toxicity (dose range, 200-800 mg daily).
15772602|NCT04674332|Drug|Long acting insulin|long acting insulin analogue once daily at bed time
15772603|NCT04674332|Drug|multiple dose regimen|intermediate and short acting insulin
15772604|NCT04674319|Behavioral|external cues and cogntive movement strategies|"external cueing are sensory stimuli such as auditory (e.g. rhythmic metronome beats) or or visual (e.g. spaced lines on the floor). Cognitive movement strategies refer to focusing attention on a specific parameter of gait (e.g. step length, arm swing).
~In the study participants walk under four walking conditions:1)usuall (baseline) walking 2)walking while attending to external cues wich will be applied via metronome beats. The number of beats per minute is adjusted to each participant's steps number per minute. 3)walking with movement cognitive strategy: participants are requested to focus on their step length- and focus on increasing their step length while walking 4) Dual tasking-walking while performing a cognitive task.
~During the four walking conditions Brain engegament will be measured, using the single-channel EEG system (Brain-MARC LTD) described in the follwing outcomes measures section."
15772605|NCT04674306|Biological|α-lactalbumin vaccine|"α-lactalbumin vaccine will be administered subcutaneously in rotating sites (vaccine will not be administered in the arms of any participant, due to likelihood of prior bilateral mastectomy).
~DL1: 10 mcg
~DL2: 100 mcg
~DL3: 1000 mcg"
15772606|NCT04674306|Biological|Zymosan|"Adjuvant used in vaccine preparation
~DL1: 10 mcg
~DL2: 100 mcg
~DL3: 1000 mcg"
15772607|NCT04674293|Drug|Revelisa|Thrombolytic therapy for patients with ischemic stroke
15772608|NCT04674280|Procedure|aHSCT|Autologous haematopoietic stem cell transplantation
15772609|NCT04674267|Other|Focus Group|Discussions on care needs conducted in a 1:1 interview or group format by phone or video
15772610|NCT04674254|Drug|Bevacizumab Injection|Bevacizumab will be intravitreally injected every 4 weeks through 12 weeks then pro re nata thereafter for 12 months.
15772611|NCT04674254|Procedure|Targeted retinal photocoagulation|Targeted retinal photocoagulation will be administered to nonperfused areas detected on fundus fluorescein angiography at baseline and repeated every 3 months as needed for 12 months.
15772612|NCT04674254|Procedure|Standard pan-retinal photocoagulation|Standard pan-retinal photocoagulation will be applied to perfused and nonperfused areas of the retinal periphery at baseline and every 3 months as needed for 12 months.
15772613|NCT04674241|Drug|Dexmedetomidine|200ug dexmedetomidine will be diluted into a 50ml syringe and administered with 0.4ug/kg/min until the dura is beginning to be sutured.
15772614|NCT04674241|Drug|0.9% saline|0.9% saline is administered with the same volume at the same speed as the other group.
15772615|NCT04674228|Other|Electronic Health Record Review|Review of medical records
15772616|NCT04674215|Behavioral|Turning in Bed|Preoperative Turning in Bed Training
15772617|NCT04674215|Behavioral|Mobilization|Preoperative Mobilization Training
15772618|NCT04674215|Other|information|Routine Clinical Care
15772619|NCT04674202|Other|Phone interview|The participant will have 2 phone interview in which they will be asked about their knowledge of direct oral anticoagulants.
15772620|NCT04674189|Biological|CVnCoV Vaccine|Intramuscular injection
15772621|NCT04674189|Drug|Placebo|Intramuscular injection
15772622|NCT04674176|Drug|Rifaximin|550 mg of Rifaximin 3 times a day for 12 days at the start of the diet.
15772623|NCT04674163|Biological|Blood sample and Cerebrospinal fluid (CSF) collection.|An additional blood sample (25 ml) and a cerebrospinal fluid (CSF) sample (2 ml) will be taken.
15772624|NCT04674150|Device|ARISE with AR|An augmented reality game for mobile devices with AR experiences enabled
15772625|NCT04674150|Device|ARISE without AR|An augmented reality game for mobile devices with AR experiences disabled as an control
15772626|NCT04674137|Drug|XC8 100 mg|1 tablet of XC8 100 mg once daily in the morning during 12 weeks of treatment period.
15772627|NCT04674137|Drug|Placebo|1 tablet of placebo once daily in the morning during 12 weeks of treatment period.
15772629|NCT04674111|Device|Temporary Percutaneous Transvalvular Circulatory Support System (Vortex System)|The Vortex System is indicated to provide temporary circulatory support in subjects undergoing elective high-risk percutaneous coronary intervention (HR-PCI).
15772630|NCT04674098|Device|The Beat Analytics System (BAS)|There are three subsystems to the BAS; data aggregation, data analysis and data presentation.
15772631|NCT04674072|Other|Reverse Nordic curl exercise|The reverse Nordic curl is a body-weight exercise which mainly works the quadriceps and hip flexors. It has a large eccentric component, meaning the muscles are working whilst lengthening.
15772632|NCT04674072|Other|Usual warm up|Usual warm up is defined as any basic exercises performed before a performance or practice to prepare the muscles for vigorous actions.
15772633|NCT04674059|Other|patient survey|A questionnaire will be delivered by the health care providers at Ndera Hospital, Kigali, Rwanda or CHUK, Hospital, Kigali, Rwanda. The questions will explore the patient's clinical characteristics, the current treatment and their experience with the mental health care system.
15772634|NCT04674046|Device|Nonoperative treatment|Patients where the ankle is evaluated as stable using arthroscopy will be treated with conservative treatment using a functional brace (AirCast) for 6 weeks. Participants will be instructed to bear weight as tolerated and to actively do standardized range-of-motion exercises.
15772635|NCT04674046|Procedure|Operative treatment|Patients where the ankle is evaluated as unstable using arthroscopy will be operated on. Standard operative treatment is open reduction and internal fixation (ORIF) of the fracture using plate and screws. The goal is an osteosynthesis that allow for early range-of-motion exercises, but weightbearing is usually not tolerated until 6 weeks postoperatively.
15772636|NCT04674046|Behavioral|Standardized education|All participants, regardless of group allocation, will receive education focusing on basic self- management. A physiotherapist will be responsible for the education. The intention will be to increase self-efficacy and encourage self-management. Participants will learn about crutch walking, cast or orthosis usage, loading principles, be advised to stay physically active within proper restrictions and how to rest and reduce pain and swelling of the ankle in the acute phase. Participants will also receive a standard information brochure about the condition, treatment and basic self-management.
15772637|NCT04674020|Drug|Erenumab|Erenumab 70 mg or 140 mg packed in a SureClick® Autoinjector Pen (AI)
15772638|NCT04674007|Other|3D analysis of landing task|Landing tasks (anticipated, unanticipated and cognitive dual task) are investigated with 3D analysis by using an opto-electronic system
15772639|NCT04673994|Behavioral|Single, acute bout of high intensity interval exercise|Individuals will perform a single bout of high intensity interval exercise on a seated recumbent stepper. Participants will perform the pattern of high intensity interval exercise by switching between 1-minute high intensity stepping followed by 1-minute light, active recovery stepping for a total of 10 minutes.
15772640|NCT04673981|Diagnostic Test|diagnostic tes for neuropathic pain|Thermotest and hot water, cold water (for the oral cavity), Von frey filament and the brush
15772641|NCT04673968|Other|prehabilitation|inhospital exercise training 5 times/week, 5~6 weeks during nCRT; home exercise 5 times/week, 5~6 weeks, between completion of nCRT and before surgery
15772642|NCT04673955|Drug|Encorafenib|Observation of real-life treatment with encorafenib and cetuximab
15772643|NCT04673955|Drug|Cetuximab|Observation of real-life treatment with encorafenib and cetuximab
15772644|NCT04673942|Biological|AdAPT-001|Oncolytic virus administered by intratumoral injection
15772645|NCT04673916|Drug|Healing evaluation|Treatments were topically applied for 5 days
15772646|NCT04673903|Other|Copenhagen adduction exercise|The Copenhagen Adduction exercise is a simple isolated eccentric partner exercise and doesn't require special equipment and can be performed as a warm up activity on the pitch.
15772647|NCT04673903|Other|Usual warm up|Usual warm up is defined as any basic exercises performed before a performance or practice to prepare the muscles for vigorous actions.
15772648|NCT04673877|Drug|Systemic IV Vancomycin|1 g of vancomycin will be delivered intravenously over a period of one hour prior to tourniquet inflation.
15772649|NCT04673877|Procedure|Bier Block|After exsanguination of the limb and elevation of the tourniquet in the prepped and draped patient, Vancomycin will be injected into a superficial vein in the hand, wrist or forearm.
15772650|NCT04673877|Drug|Vancomycin|500 mg diluted in 50 cc normal saline of injection into superficial vein in the hand, wrist or forearm
15772651|NCT04673864|Drug|CKD-386|QD, PO
15772652|NCT04673864|Drug|D012, D326, D337|QD, PO
15772687|NCT04673604|Drug|mean diurnal intraocular pressure-lowering|At the end of each 6-month period patients will undergo diurnal intraocular pressure assessment with both therapies.
15839761|NCT04126200|Drug|Dostarlimab|Dostarlimab will be administered.
15772653|NCT04673851|Device|Horyzons USA|Participants will be oriented to the site (online platform) and how to use it. The site includes curated therapeutic content surrounding issues such as generalized anxiety, social anxiety, social functioning, depression, and distress tolerance. The site also includes a social media function, in which participants and peer support specialists can post text, images, and videos. The site is monitored by graduate students and trained clinicians.
15772654|NCT04673838|Other|neurodevelopmental therapy|Considering the individual needs and wishes of the patient, an exercise program will be created for each patient in accordance with their functional levels and supporting active participation of the person. The treatment program tailored to the patient; It will include weight transfer to the affected side in different positions, functional reaching out activities, stepping forward and walking activities.
15772655|NCT04673838|Other|Lower extremity sensory training|Lower extremity sensory training will only be applied to the Intervention Group for 4 weeks, 3 days a week and 12 sessions in total. In the lower extremity, 3 sets of soft tissue needing, stroking and fascia stretching will be applied on 5 areas as Quadriceps, Hamstring, Gastrosoleus Group, Peroneal muscles, ankle and foot. In addition, sensory stimulation will be applied in the same five regions of the lower extremity with 3 repetitions and 3 sets with a knurled ball, brush and sponge. Lower extremity mobilizations of PANat Therapy approach will be used with traction and gliding applications in all joints in the ankle and foot. Finally, intrinsic muscle stimulation will be performed for 3 minutes with a bottle and towel under the sole of the foot.
15772656|NCT04673825|Other|Patient initiated care + telemonitoring|See arm/group descriptions.
15772657|NCT04673812|Drug|Bupivacaine-fentanyl|"Bupivacaine-Fentanyl (BF) group (46 patients): will receive spinal anaesthesia with 12.5 mg hyperbaric Bupivacaine 0.5% (2.5 mL) plus 25 µg Fentanyl (0.5 mL) and (0.5 mL) normal saline added in the same syringe in a total volume of 3.5 mL.
~Bupivacaine-Fentanyl-Naloxone (BFN) group (46 patients): will receive spinal anaesthesia with 12.5 mg hyperbaric Bupivacaine 0.5% (2.5 mL) plus 25 µg Fentanyl (0.5 mL) and 20 µg Naloxone (prepared in 0.5 mL normal saline) added in the same syringe in a total volume of 3.5 mL."
15772658|NCT04673799|Drug|MV088 injection|MV088 injection (60mg) by subcutaneous injection once on the first day
15772659|NCT04673799|Drug|Prolia® injection|Prolia® injection (60mg) by subcutaneous injection once on the first day
15772660|NCT04673786|Biological|CT-P43|45mg or 90mg dose subcutaneous administration
15772661|NCT04673786|Biological|Stelara|45mg or 90mg dose subcutaneous administration
15772662|NCT04673773|Behavioral|A Massive Open Online Course|Same as intervention
15772663|NCT04673760|Behavioral|Highly structured specialized palliative home care (PROAKTIV)|"Specialised palliative home care teams will initiate and manage a systematic and collaborative process of advance care planning with patients, family caregivers, GPs and SPITEX nurses using the Betreuungsplan, information packages and regular case meetings."
15772664|NCT04673760|Behavioral|Normally structured specialized palliative home care|Specialised palliative home care teams will provide care as usual
15772665|NCT04673747|Procedure|Total Hip Arthroplasty|Total replacement of the head, femoral neck and acetabulum of the hip joint with specialized implants
15772666|NCT04673747|Procedure|Manual correction of the sacroiliac joint|Manual correction of the iliosacral displacement of the sacroiliac joint in total hip arthroplasty is performed in the operating room after anesthesia just before total hip arthroplasty. It is carried out according to the methodology developed by us.
15772667|NCT04673734|Diagnostic Test|myelin sensitive MRI scan|"Acquisition of 3 myelin sensitive MRI scans as follows: 1. Two MRI during 1 day; the second after 30 min interval and a repositioning.
~2. One MRI within one week after the first one.
~The total scan time will be ~ 1 hour. T1 maps will be calculated after magnetization-prepared 2 rapid acquisition gradient echoes (MP2RAGE6) acquisition based on a product sequence. Magnetization Transfer (MT) sat maps will be calculated. Quantitative susceptibility mapping (QSM) maps will be reconstructed using an in-house implementation of the structural feature based collaborative reconstruction algorithm (SFCR). For the reconstruction of multi-shell diffusion data, AMICO10 Accelerated Microstructure Imaging via Convex Optimization (AMICO) from diffusion MRI data will be used. Myelin Water Fraction maps will be fitted voxel-wise using a Non-Negative Least Squares fitting."
15772668|NCT04673721|Dietary Supplement|Fortified eggs|Average 12 eggs consumed per week
15772669|NCT04673721|Behavioral|Intermittent fasting|16-hour fast and then an 8-hour nutritional window with aim for energy needs to be consumed during an 8 hour eating window (e.g., 11 am - 7 pm) with fasting for 16 hours (e.g., 7 pm - 11 am the next day).
15772670|NCT04673721|Dietary Supplement|Non-egg supplemented|2 or less eggs consumed per week
15772671|NCT04673721|Behavioral|Usual care diet|Consistency with current diet without consideration of intermittent fasting
15772672|NCT04673708|Diagnostic Test|H - Test|Showing different videos for a sexual stimulus and monitor the vitals of each participants to measure any changes can occur with each video.
15772673|NCT04673695|Drug|Lixiana(D006)|NOAC(Factor Xa inhibitor)
15772674|NCT04673695|Drug|CKD-344|NOAC(Factor Xa inhibitor)
15772675|NCT04673682|Drug|D309|D309(Testosterone) 1 vial, Once, IM injection
15772676|NCT04673682|Drug|CKD-845|CKD-845(Testosterone) 1 vial, Once, IM injection
15772677|NCT04673669|Diagnostic Test|Posterior tibial tendon strength mesure|Posterior tibial tendon strength is assessed with a hand-held dynamometer by two independent observer and with an isometric dynamometer by one observer.
15772678|NCT04673656|Dietary Supplement|BKR-017|Nutrient butyrate into a colon-targeted tablet formulation (BKR-017) is intended to stimulate secretion of GLP-1 from L-cells in the lower gut. Butyrate delivered to the colon in tablet form will not cause the side-effects seen with formation of butyrate by fermentation.
15772679|NCT04673643|Device|Transcutaneous Auricular Vagus Nerve Stimulation|to use taVNS to treat Reflux Esophagitis
15772681|NCT04673617|Drug|AB-101|NK cell therapy
15772682|NCT04673617|Drug|Rituximab|Anti-CD20 antibody therapy
15772683|NCT04673617|Drug|Interleukin-2|Immune cytokine
15772684|NCT04673617|Drug|Cyclophosphamide|Lymphodepleting chemotherapy
15772685|NCT04673617|Drug|Fludarabine|Lymphodepleting chemotherapy
15772686|NCT04673604|Diagnostic Test|Assessment of ocular surface staining (Oxford score 0-15 scale)|Corneal and conjunctiva staining will be recorded according to the Oxford grading scheme for ocular staining (0-15 score).
15772688|NCT04673591|Drug|Tregalizumab|a monoclonal antibody designed for the treatment of allergic asthma indication
15772689|NCT04673591|Other|Placebo|Matched Placebo
15772690|NCT04673578|Drug|Celecoxib|Selective COX-2 inhibitor; nonsteroidal anti-inflammatory drug (NSAID)
15772691|NCT04673578|Other|Placebo|Microcrystalline cellulose
15772692|NCT04673565|Behavioral|Motivational interviewing|Each participant in the treatment group will attend a 1-hour MI group session with 9 other participants hosted by a practicing MI therapies via Zoom at one month after the initial visit. This session will utilize MI to elicit motivation in each participant. Participants will also receive standard care delivered at in-person audiology clinic visits.
15772693|NCT04673552|Procedure|laparotomy|Any open procedure such as laparotomy or lumbotomy for acute necrotizing pancreatitis will be evaluated, with assessment of results, complications and deaths
15772694|NCT04673539|Diagnostic Test|Spanish version of the Brief-BESTest in stroke patients|Adaptation and validation of the Spanish version of the Brief-BESTest in stroke Patients
15772695|NCT04673526|Procedure|Laparoscopic intersphincteric resection|Laparoscopic intersphincteric resection for ultra low rectal cancer in elderly patients
15772696|NCT04673526|Procedure|Laparoscopic abdomino-perineal procedures|Abdominoperineal resection + colostomy in left iliac fossa or perineum
15772697|NCT04673513|Other|Psychotherapy|In light of COVID-19 considerations, interventions are currently being provided via telehealth technology.
15772698|NCT04673500|Drug|Propofol lidocaine through large vein|A mixture of 2% lidocaine 1 ml and 1% propofol 2mg/kg was given through a large antecubital vein to assess pain severity on propofol injection during general anesthesia induction
15772699|NCT04673500|Drug|Propofol lidocaine through small vein|A mixture of 2% lidocaine 1 ml and 1% propofol 2mg/kg was given through a small vein on the dorsum of hand to assess pain severity on propofol injection during general anesthesia induction
15772700|NCT04673487|Diagnostic Test|1. SD Bioline Salmonella Typhi IgG/IgM Fast test, 2. Typhidot Rapid IgG/IgM combo test, 3. TUBEX TF test, 4.Typhoid IgG/IgM Combo Rapid Test CE, 5. Enterocheck WB test, 6. Test-itTM Typhoid IgM test|Evaluation of 11 different Typhoid Rapid Diagnostic Tests that are commercially available internationally and use Blood culture as standard for comparison
15772701|NCT04673474|Drug|Hemay022|Participants will receive a single oral dose of Hemay022 tablet in fasted condition on Day 1 of treatment period 1 followed by a single oral dose of Hemay022 tablet in fed condition on Day 8 of treatment period 2. A washout period of 7 days will be maintained between the 2 treatment periods.
15772702|NCT04673474|Drug|Hemay022|Participants will receive a single oral dose of Hemay022 tablet in fed condition on Day 1 of treatment period 1 followed by a single oral dose of Hemay022 tablet in fasted condition on Day 8 of treatment period 2. A washout period of 7 days will be maintained between the 2 treatment periods.
15772703|NCT04673461|Drug|STA363 containing 90 mg (60 mg/mL) lactic acid|STA363 containing 90 mg (60 mg/mL) lactic acid will be injected into the center of up to two intervertebral discs.
15772704|NCT04673461|Drug|STA363 containing 180 mg (120 mg/mL) lactic acid|STA363 containing 180 mg (120 mg/mL) lactic acid will be injected into the center of up to two intervertebral discs.
15772705|NCT04673461|Other|Placebo|Placebo will be injected into the center of up to two intervertebral discs.
15772708|NCT04673435|Device|PermeaDerm for temporary coverage|See above
15772709|NCT04673435|Device|FHCA for temporary coverage|See above
15772710|NCT04673435|Device|PermeaDerm over autograft|See above
15772711|NCT04673435|Device|FHCA over autograft|see above
15772712|NCT04673422|Drug|Montelukast|A 10-mg tablet will be given orally immediately and every day thereafter for 10 days or until recovery, defined as the discontinuation of the follow up appointment by the attending physicians, whichever is shorter
15772713|NCT04673422|Drug|Placebo|A 10-mg tablet will be given orally immediately and every day thereafter for 10 days or until recovery, defined as the discontinuation of the follow up appointment by the attending physicians, whichever is shorter
15772714|NCT04673409|Diagnostic Test|Novel Cardiac MRI sequences|Novel CMR sequences that allow accurate multiparametric evaluation of the whole myocardium with 3D high spatial resolution and in a patient-friendly free-breathing approach in a predictable amount of scanning time (3D T2 mapping and 3D anatomical and LGE imaging). This will be compared to the data acquired with conventional/2D sequences.
15772715|NCT04673396|Drug|Norcantharidin Lipid Microsphere for Injection|"The test drug was added to 5% glucose injection to a final volume of 250 mL，and administered by instillation at a rate of 200 mL/h.
~This product can be used alone or in combination with chemotherapy, and the dosage and time of administration vary with the chemotherapy regimen."
15772716|NCT04673396|Drug|Sodium Demethylcantharidate Injection|Dissolve the reference drug with appropriate amount of sterile water for injection, and add 250 mL of 5% glucose injection for slow dripping.
15772717|NCT04673383|Drug|SPL026|Intravenous solution
15772718|NCT04673383|Drug|Placebo|SPL026-matched placebo
15772719|NCT04673370|Behavioral|Ba Duan Jin|Ba Duan Jin, a traditional Chinese health-preserving technique, combines techniques regulating body, breath and spirit. According to traditional Chinese theory, every movement of Ba Duan Jin has unique effect to different Zang-fu organs.
15772720|NCT04673370|Behavioral|Health education|Health education is provided by psychologist and TCM doctor, including work, rest, diet and other basic programs.
15772723|NCT04673344|Device|Regeneten Collagen Patch|Partial rotator cuff repair surgery with the addition of the Regeneten scaffold
15772724|NCT04673331|Other|exercise capacity|3minute step test and 1minute sit to stand test used assessment of exercise capacity.
15772725|NCT04673318|Behavioral|heat therapy|leg heated garments with circulating water to conduct heat therapy at home
15772726|NCT04673318|Behavioral|exercise training|A velocity based training program will be implemented at home using a mobile app allowing for the quantification the relative intensity.
15772816|NCT04672512|Drug|CORT125329 lipid capsule formulation|CORT125329 lipid capsule formulation 1 or 2 for oral administration
15772727|NCT04673305|Other|Cognitive Assessment, Cytokine dosage|Once the patient's informed consent has been acquired, a neurological examination is carried out, with functional tests required by the protocol. The patient carries out, as per clinical practice, the treatment provided for the cure of his disease. The evaluation of the tests is repeated at 6 months and 12 months after enrollment in the study. In conjunction with a venipuncture performed for the exams required by clinical management, a blood sample is taken to measure the cytokines involved in inflammatory processes.
15772728|NCT04673292|Behavioral|Fixed site standard of care testing|This arm includes all three Johns Hopkins (JHMI) ambulatory outdoor testing sites across Baltimore City. Each site represents a traditional appointment-based scheduling system. Participants will be given a choice of 1 of 3 outdoor testing locations based on their preferences. Study staff will make an appointment for testing based on testing availability and participant schedule.
15772729|NCT04673292|Behavioral|Community-based, mobile van testing|This arm offers the convenience of highly accessible testing and with the flexibility of no fixed appointment time. Each of the 12 geographic strata will have a single, centrally located testing site within the area, providing similar geographic access across households. The testing location will be published on the study website and social media so that participants can visit the location at a time convenient to them.
15772730|NCT04673292|Behavioral|Self-collected, home-based testing|Individuals will receive a home-based testing kit delivered by a courier service as soon as the randomization of the household is complete. The kit will include provisions for contacting the courier service for pick up. Appropriate biohazard precautions are included. Each of the testing components of this kit will include FDA Emergency Use Authorization approved collection methods. Easy to use instructions with options to view pre-recorded videos and/or virtual 'on demand' coaching sessions with members of the study team via a HIPAA-secure Zoom session will be available.
15772731|NCT04673279|Diagnostic Test|serology|An enzyme linked immunosorbent assay (ELISA) developed and validated in Argentina which detects antibodies against two viral antigens, trimeric spike and the receptor binding domain (RBD) of the spike protein.
15772732|NCT04673266|Drug|Romiplostim|All patients will begin weekly (+/- 2 days) romiplostim at 3 mcg/kg subcutaneously. The romiplostim dose will be titrated, based on weekly CBC/platelet counts.
15772733|NCT04673253|Other|Passive leg Raise|The intervention will be performed immediately after spinal anesthesia, and passive leg raise will be performed using two standard pillows placed under the heel so that the leg is approximately 30 cm above the horizontal plane of the table. The passive leg raising position will continue until the cord is clamped.
15772734|NCT04673253|Other|control|The controlled group was positioned in the normal supine position.
15772735|NCT04673240|Drug|Botulinum toxin type A injection|"Adult patients with spasticity due to traumatic brain injury, spinal cord injury, or MS, treated with Botulinum Toxin type A.
~As this is a non-interventional study, no diagnostic, therapeutic, or experimental intervention is involved. Subjects will receive clinical assessments, medications, and treatments solely as determined by their study physician."
15772736|NCT04673227|Diagnostic Test|Blood draw|Blood draw and the analysis of blood in laboratory
15772737|NCT04673214|Drug|Azithromycin / Ivermectin / Ribaroxaban / Paracetamol|In the patient with the presence of COVID-19 confirmed by the PCR-COVID-19 positive test, the drug is randomly assigned to belong to group A of Azithromycin / Ivermectin / Ribaroxaban / Paracetamol to be followed for 14 days by video call (approximately 15 to 20 min per day) to the patient and the presence or absence of clinical symptoms, adverse reactions being recorded daily
15772738|NCT04673214|Drug|Azithromycin / Ribaroxaban / Paracetamol|In the patient with the presence of COVID-19 confirmed by the PCR-COVID-19 positive test, the drug is randomly assigned to belong to group B of Azithromycin / Ribaroxaban / Paracetamol, to be followed for 14 days by video call (approximately 15 to 20 min per day) to the patient and the presence or absence of clinical symptoms, adverse reactions being recorded daily
15772739|NCT04673201|Procedure|"Viscotrabeculotomy Versus trabeculectomy with MMC"|Viscotrabeculotomy involved the creation of a partial thickness scleral flap, followed by localization of Schlemm's canal by radial incisions.High viscosity sodium hyaluronate was injected into Schlemm's canal.Trabeculotomy was completed using the standard metal Harm's trabeculotome.The scleral flap was then secured and conjunctival closure ensued.Trabeculectomy technique involved a creation of a limbal-based conjunctival flap, followed by creation of a half-thickness sclera flap. MMC was applied underneath the conjunctival flap.The procedure was completed with both sclera and conjunctiva closed by 10/0 nylon sutures.
15772740|NCT04673188|Procedure|Reconstruction of MPFL with or without tibial tuberositas osteotomy|Reconstruction of the medial patellofemoral ligament with autologous grafts with or without osteotomy and transfer of tibial tuberosities.
15772741|NCT04673175|Drug|Ceftolozane / Tazobactam Injection|Zerbaxa (ceftolozane/tazobactam) for injection is supplied as a white to yellow sterile powder for reconstitution in single-use vials; each vial contains 1 g ceftolozane (equivalent to 1.147 g of ceftolozane sulfate) and 0.5 g tazobactam (equivalent to 0.537 g of tazobactam sodium).
15772742|NCT04673162|Drug|Methylprednisolone, Placebo|iv administration
15772743|NCT04673149|Biological|GLS-5310|GLS-5310 DNA plasmid vaccine
15772744|NCT04673149|Biological|Placebo|Placebo
15772745|NCT04673136|Device|GI-GENIUS Medtronic|Colonoscopy assisted by GI-GENIUS device
15772746|NCT04673136|Other|Colonoscopy|Standard colonoscopy
15772747|NCT04673123|Other|Core stabilization exercises|"In our study, core stabilization exercises to be applied in the intervention group are arranged according to the patients with stroke and will be at three different difficulty levels. Exercises will be done on the back (hooked) and sitting positions where the risk of falling is low. First of all, activation of the transversus abdominis muscle, which is the basis of core stabilization, will be taught to patients. With this activation at the first level, the healthy side, at the second level the affected side, and at the third level, reciprocal upper and lower extremity movements will be requested. In addition to these, there will be exercises to bridge and curl up in supine position, and weight transfer in sitting position. In order to increase the difficulty level of the exercises, first of all, the number of exercises will be increased and then it will be asked to move on to the next level."
15772778|NCT04672837|Procedure|Pediatric Integrative Manual Therapy and educational therapy|Pediatric Integrative Manual Therapy is a soft Orthopedic Manual Therapy approach por infants and children. It integrates joints soft mobilisation, myofascial release and neurodynamic mobilisation. Also the educational therapy.
15772748|NCT04673123|Other|Traditional physical therapy|The content of this program includes physical therapy and rehabilitation practices that are routinely applied in stroke rehabilitation and that patients will receive at the specified hospital. In the content of these applications; patient-specific upper and lower extremity stretching, relaxation and strengthening exercises; application of functional electrical stimulation (FES) to upper and lower extremity muscles; balance, coordination and gait training are included.
15772749|NCT04673123|Other|Informing about fall prevention|The content of multifactorial fall prevention training includes the first brochure titled '' General Recommendations for the Prevention of Fall in Chronic Stroke Patients '', which will include general recommendations for preventing falling according to the fall risk factors specific to the stroke, and the recommendations to minimize the risk of falling in the home. A second brochure titled 'Suggestions for Making Your Home Safer' will be given. The information in these brochures will also be communicated to patients face to face verbally
15772750|NCT04673110|Diagnostic Test|Neutrophil to Lymphocyte Ratio and C-reactive protein|Zahorec et al. identified the neutrophil-lymphocyte ratio (NLR) as an inflammation marker in critical patients, defining as the absolute neutrophil count divided by the absolute lymphocyte count
15772751|NCT04673097|Other|Icon® resin infiltration|low viscosity resin that can flow through the pores in the enamel surface
15772752|NCT04673097|Other|MI paste plus|s a superior form of fluoride ions as it also contains CPP-ACP, enhances mineral release without encouraging the formation of calculus.
15772753|NCT04673084|Device|negative pleural suction|by comparing the effect of water seal alone of chest tube in one groups of trauma patients and the effect of both water seal and suction in other group
15772754|NCT04673071|Other|Thread Embedding Acupuncture (TEA)|"TEA in 1 month for 4 months The six TEA points used in this study are GV20, BL15, BL18, ST40, GV14 and GB34.
~Acupuncture point Procedure Baihui (GV20) oblique insertion toward nose, 3cm Both Xin Shu (BL15) perpendicular insertion, 3cm Both Gan Shu (BL18) perpendicular insertion, 3cm Both Fenglong (ST40) perpendicular insertion, 3cm Dazhui (GV14) perpendicular insertion, 3cm Both Yanglingquan (GB34) perpendicular insertion, 3cm"
15772755|NCT04673071|Other|Sham-TEA (STEA)|STEA in 1 month for 4 months All procedure of Sham-TEA group, including acupoints and size of TEA will be same as that of TEA group. However, thread-removed TEA will be used for STEA group instead of normal TEA, and removing procedure of thread will be performed aseptic and secretly for patient-blinding and prevention of infection.
15772758|NCT04673045|Device|Active Electrical stimulation|The intensity of stimulation will be set within the subject's tolerance level. The amplitude was adjusted to produce muscle contraction without affecting the patient's comfort. The cathode electrode will be placed over the common peroneal nerve as it passes over the head of the fibula and the anode will be placed on mid-muscle belly on one third of the line between fibular head and medial malleolus on paretic limb.
15772759|NCT04673045|Device|Sham Electrical Stimulation|For sham group, the current intensity will gradually decreased after few seconds to 0. Therefore, the participant will experience a passage of current on the muscle at the beginning but received no current for the rest of the stimulation period. The participants will be informed that the stimulation below the sensory level.
15772761|NCT04673019|Behavioral|Nurse AMIE (Addressing Metastatic Individuals Every day)|Supportive Care Platform (behavioral interventions that are offered based on answers to daily symptom rating questions). Interventions offered include walking, balance, strength exercise, guided relaxation, CBT, DBT, soothing music.
15772762|NCT04672993|Device|Urine collection device for men|Use of urine collection device for men
15772763|NCT04672980|Drug|RTX-321|RTX-321 monotherapy
15772765|NCT04672954|Drug|BI 474121|BI 474121
15772766|NCT04672954|Drug|Placebo|Placebo
15772767|NCT04672941|Drug|Tiotropium bromide plus Olodaterol|Tiotropium bromide plus Olodaterol
15772768|NCT04672928|Drug|paclitaxel|Paclitaxel injection
15772769|NCT04672928|Biological|IBI318|lBI318 injection
15772770|NCT04672915|Diagnostic Test|test of HBV DNA|Real time PCR or nested PCR to check
15772771|NCT04672902|Procedure|Single-operator cholangioscopy guided electrohydraulic lithotripsy|Single-operator cholangioscopy guided electrohydraulic lithotripsy has the advantage of providing direct visualization of the bile ducts, enabling a single physician to diagnose and perform the therapeutic intervention in a single procedure.
15772774|NCT04672876|Drug|Telotristat Ethyl Oral Tablet|XERMELO is a prescription pill, used along with somatostatin analog (SSA) therapy, for Carcinoid Syndrome diarrhea in adults who are not adequately controlled by SSA therapy. The drug is currently FDA-approved for this use but this study has received special approval from the FDA (under an Investigational Drug Application) to study telotristat ethyl in individuals with carcinoid tumors who plan to undergo surgery.
15772775|NCT04672863|Behavioral|Dietary Intervention|Modified Mediterranean diet approved by the Nutrition Team at the Transplant Center and it emphasizes consumption of fruits, vegetables, whole grains, beans and nuts, in addition to low salt (2-2.4g/day), moderate amounts of lean protein (primarily fish and poultry) in addition to low to moderate quantities of monounsaturated fats. The modifications to the traditional Mediterranean diet are: no alcohol consumption and fewer added fats. In addition, close scheduled followup on diet and progress with study team.
15772776|NCT04672850|Dietary Supplement|Probiotic|The participants will consume 2 capsules daily for three months
15772777|NCT04672850|Dietary Supplement|Placebo|The participants will consume 2 capsules daily for three months
15773080|NCT04670289|Drug|Placebo|0.9% saline
15772779|NCT04672837|Procedure|Stretching and educational therapy|It is a protocol of stretching based on literature research. Also the educational therapy with counter positioning, stimulation in prone position, positional care, etc.
15772780|NCT04672824|Biological|ChAdOx1 RVF|Single dose ChAdOx1 vectored vaccine
15772781|NCT04672824|Other|Saline|0.5ml saline placebo
15772782|NCT04672811|Device|Study App and Apple Watch|Study App and Apple Watch
15772783|NCT04672798|Behavioral|BRITEPath|BRITEPath will guide co-located mental health clinicians in the use of an emotion regulation and safety planning app (BRITE) to be loaded on the phone of depressed and suicidal adolescents in order to improve depression and reduce the likelihood of a suicide attempt.
15772784|NCT04672798|Behavioral|Treatment As Usual (TAU)|Participants in this group will receive usual care from their mental health care provider.
15772785|NCT04672785|Behavioral|SF36 questionary|patients who underwent a posterior fossa craniectomy for a cerebellar hematoma at Grenoble University Hospital between 01/01/2010 and 01/01/2020 were enrolled in this study. The main objective is to assess the level of disability and the quality of life of patients who have had a posterior cranial fossa craniectomy.
15772786|NCT04672772|Drug|Cetuximab|Weekly cetuximab at starting dose, that could be switched to biweekly
15772787|NCT04672772|Drug|Paclitaxel|Paclitaxel at starting dose of 80 mg/m2
15772788|NCT04672759|Drug|Durvalumab|Patients receive durvalumab as an intravenous infusion over 60 minutes on day 1. Courses repeat every 21 days for up to 12 months in the absence of disease progression or unacceptable toxicity.
15772789|NCT04672759|Drug|Durvalumab|Durvalumab monotherapy or combined with chemotherapy and/or radiotherapy.
15772790|NCT04672746|Behavioral|Brief MI interaction via instant communication|Telephone peer counselling+referral to treatment if required+The interaction communication using brief motivational interviewing via the chatting function of instant messaging apps (e.g., WhatsApp, WeChat). The intervention will last for 6 month with a frequency of at least twice a week.
15772791|NCT04672746|Behavioral|General health information|"Telephone peer counselling+referral to treatment if required+general health information via SMS, such as do physical exercise for at least 30 min per week will keep you healthy for 6 month with a frequency of least twice a week."
15772792|NCT04672733|Biological|Hizentra|Solution for injection for subcutaneous use
15772793|NCT04672720|Drug|L-carnitine 1000 Mg|Prescription 3mg l-carnitine (L-carnitine® tablet 1000 mg, Karen Pharmaceutical Company, Iran) daily from day 2 of the previous menstrual cycle until pregnancy test day (approximately 8 weeks).
15772794|NCT04672707|Drug|Bromhexine Hydrochloride Tablet|32 mg
15772795|NCT04672707|Drug|Bromhexine Hydrochloride Tablet|48 mg
15772796|NCT04672707|Drug|Bromhexine Hydrochloride Tablet|64 mg
15772797|NCT04672707|Drug|Bromhexine Hydrochloride Tablet|80mg
15772798|NCT04672694|Procedure|Vagus nerve block|Ropivacine 0.75% 2mL will be injected two times around the vagus nerve (just below the bifurcation of recurrent laryngeal nerve); one before starting the surgical resection of lung including complete mediasitnal lymph node dissection and one at the end of operation.
15772799|NCT04672694|Procedure|No vagus nerve block|No vagus nerve block will be conducted during the surgery.
15772801|NCT04672668|Diagnostic Test|duplex ultrasound for the common femoral artery|duplex ultrasound for the common femoral artery before and after the angiography
15772802|NCT04672655|Behavioral|ONBOARD|Session 1: Overview; Wearing diabetes devices; Session 2: Managing CGM data; Session 3: CGM & social situations; Session 4: Building trust with your CGM
15772803|NCT04672642|Device|SpyGlass DS|Detection by the SpyGlass DS of residual pancreatic stones not detected by the standard method (CT scan and ERCP)
15772804|NCT04672629|Device|echocardiography|follow up echocardiography
15772805|NCT04672616|Behavioral|Group psychotherapy|The intervention is a group psychotherapeutic offer for mentally burdened adolescents and young adults to support their professional integration.
15772806|NCT04672603|Procedure|Complete Preservation of Denonvilliers' Fascia|Patients accept L-PANP surgery with complete preservation of Denonvilliers Fascia
15772807|NCT04672590|Other|Primary exposure is hypoxia (no intervention)|The primary exposure, hypoxia, will be defined as severe, non-severe or none for each participant, based on pre-defined criteria.
15772808|NCT04672577|Other|Observational study|No intervention is planned
15772809|NCT04672564|Drug|Carrimycin|Carrimycin (400 mg) will be given once-daily for 14 days (2 x 200 mg tablets) after a meal, if a patient experiences an eating problem, carrimycin will be taken without food.
15772810|NCT04672564|Drug|Placebo|Placebo will be given once-daily for 14 days (2 tablets) after a meal, if a patient experiences an eating problem, placebo will be taken without food.
15772811|NCT04672551|Behavioral|EMDR Treatment|Eight individual EMDR sessions lasting for 1 hours will be provided over 8 weeks by licensed EMDR therapists from the German-speaking part of Switzerland. Each EMDR session follows a standardized 8-phase protocol.
15772812|NCT04672538|Procedure|Low Vt protocol|Low Vt protocol - tidal volumes (Vt) 6 ml/kg, respiratory rate required for end tidal carbon dioxide (EtCO2) of 36-38 mmHg, PEEP 5 centimeter of water (cm-H20) , I:E ratio 1:2
15772813|NCT04672538|Procedure|High Vt protocol|High Vt protocol - tidal volumes (Vt) 10 ml/kg, respiratory rate required for EtCO2 of 36-38 mm Hg, PEEP 5 cmH2O, I:E ratio 1:3.
15772814|NCT04672525|Drug|Rifabutin|2 tablets of 150 mg per day rifabutin tablet daily for 12 weeks in 1 administration with a companion treatment
15772815|NCT04672525|Drug|Rifampicin|10 mg/kg per day (range 600 mg to 1,200 mg) rifampicin tablet in 1 daily dose for 12 weeks with a companion treatment
15772817|NCT04672512|Drug|Placebo|Placebo matching CORT125329 lipid capsule formulation 1 or 2 for oral administration
15772818|NCT04672512|Drug|Prednisone|Prednisone tablet for oral administration
15772819|NCT04672499|Drug|Miricorilant 300 mg tablets|Miricorilant 300 mg tablets for oral administration
15772820|NCT04672499|Drug|Miricorilant 150 mg tablets|Miricorilant 150 mg tablets for oral administration
15772821|NCT04672499|Drug|Placebo 150 mg tablets|Placebo to match miricorilant 150 mg tablets for oral administration
15772822|NCT04672486|Behavioral|POD Adventures|"Participants in the intervention arm will receive information about local services/national helplines and a brief problem-solving intervention that is delivered through a smartphone app with telephone guidance from a lay counsellor. The intervention is grounded in stress-coping theory, with a technical focus on practical problem solving. The emphasis on problem solving reflects the primacy of psychosocial stressors in adolescent help-seeking. Moreover, problem-solving is among the most commonly used practice elements in evidence-based psychological interventions for children and adolescents globally.
~The content of the app comprises two sections: 'Adventures' which teaches problem-solving concepts and methods through contextually-appropriate games; and 'My POD' which scaffolds the student through the application of step-by-step problem-solving procedures to their own prioritized problems."
15772823|NCT04672473|Biological|DC-CTL|DAC combined with Ag-CTL
15772827|NCT04672447|Dietary Supplement|L-Citrulline|Four weeks of oral L-Citrulline (2 grams/day) supplementation. Supplementation will be ingested daily, half of the doses in the morning and half at night.
15772828|NCT04672447|Dietary Supplement|L-Citrulline|Four weeks of oral L-Citrulline (6 grams/day) supplementation. Supplementation will be ingested daily, half of the doses in the morning and half at night.
15772829|NCT04672447|Dietary Supplement|Placebo|Four weeks of oral placebo (6 grams/day maltodextrin) supplementation. Supplementation will be ingested daily, half of the doses in the morning and half at night.
15772830|NCT04672447|Dietary Supplement|Glutathione|Four weeks of Glutathione (200mg/day) supplementation. Supplementation will be ingested daily, half of the doses in the morning and half at night.
15772831|NCT04672434|Drug|Sym021|Sym021 is a humanized anti-PD-1 antibody.
15772832|NCT04672434|Drug|Sym024|Sym024 is an anti-CD73 antibody.
15772833|NCT04672421|Device|Medicurtain®|Anti-adhesion barrier (Medicurtain® 5ml prefilled syringe after laparoscopic surgery)
15772834|NCT04672421|Device|Placebo|No device after laparoscopic surgery
15772835|NCT04672408|Device|His bundle pacing|Pacing with capture of the His bundle
15772836|NCT04672408|Device|Right ventricular pacing|Pacing from the right ventricular lead (septal or apical)
15772837|NCT04672395|Biological|CpG 1018/Alum-adjuvanted SCB-2019 vaccine|Group 1: Participants will receive 1 intramuscular (IM) injection of 30 microgram (ug) SCB-2019 with CpG 1018/Alum adjuvant on Day 1 and on Day 22
15772838|NCT04672395|Biological|Placebo; 0.9% saline|Group 2: Participants will receive 1 IM injection of SCB-2019-matching placebo on Day 1 and on Day 22
15772839|NCT04672382|Drug|Morphine|During the 1st session, each of the middle forearms of the subject will be divided into two squared areas (4x4 cm) located 3 cm apart. Two areas will be treated with an intradermal injection of morphine (0.05 ml, 0.1 mg/ml), and two areas with an intradermal injection of isotonic saline.
15772840|NCT04672369|Biological|IBI939|IBI939 injection
15772841|NCT04672369|Biological|Sintilimab|Sintilimab injection
15772842|NCT04672356|Biological|IBI939|IBI939 injection
15772843|NCT04672356|Biological|Sintilimab|Sintilimab injection
15772844|NCT04672343|Other|Data collection|from D0 to hospital discharge
15772845|NCT04672343|Other|Querying the INSEE database|Vital status at 3 months and 12 months
15772846|NCT04672330|Drug|Tislelizumab|Patients will receive 2-4 cycles of Tislelizumab (200mg per cycle) before radical nephroureterectomy and lymphadenectomy.
15772847|NCT04672317|Drug|Immunotherapy combined with chemotherapy|"Patients will receive 2-4 cycles of Tislelizumab (200mg per cycle) in combination with cisplatin-based chemotherapy before radical nephroureterectomy and lymphadenectomy.
~Drug: Tislelizumab 200 mg per cycle, IV on day 14 of every 3-week cycle, for 2-4 cycles prior to radical nephroureterectomy and lymphadenectomy
~Other Names:
~• anti-PD-1 monoclonal antibody Drug: Cisplatin 70mg/m2 IV on day 2of every 3-week cycle, for 2-4 cycles prior to radical nephroureterectomy and lymphadenectomy. Dose fractionation is permissible.
~Drug: Gemcitabine 1000mg/m2 IV on day 1 and Day 8 of every 3-week cycle, for 2-4 cycles prior to radical nephroureterectomy and lymphadenectomy"
15772848|NCT04672304|Other|Al-Husban University Naser|filling a questionnaire
15772849|NCT04672291|Drug|Poly-ICLC (Hiltonol®) or Placebo|The safety cohort (Cohort A) consists of 13 patients who will be randomized to receive 2 cycles of the study drug (N10) or 2 placebo cycles (N3).
15772850|NCT04672291|Drug|Poly-ICLC (Hiltonol®) or Placebo|The expansion cohort will receive 3 cycles of therapy. A total of 30 patients will be accrued and randomized 4:1 to receive drug (N=24) or placebo (N=6).
15772851|NCT04672278|Dietary Supplement|Shanzha Fruit drink or placebo drink|The dosage of Shanzha fruit drink or the placebo is 3 cans per day
15772852|NCT04672265|Other|Mother tongue and Norwegian|The screening invitation letter, the information leaflet, the reminder letter and the result letter will be sent in two languages; an official language in the country where the invitee is born, and Norwegian.
15772853|NCT04672252|Other|CBD Oral Disintegrating Tablet (ODT)|Cohort 1: CBD ODTs to be administered with routine post-operative pain management regimen
15772854|NCT04672252|Other|Placebo ODT|"Cohort 2 will not receive CBD; but a visually indistinguishable placebo ODT instead.
~The resident physician, physician assistant, anesthesiologist, surgeon and study team members will remain blinded. Additionally, all patients will receive a traditional upper extremity interscalene block as per routine."
15772855|NCT04672239|Behavioral|"Smartphone app Smiling instead of Smoking (SiS) Version 3"|Participants will be onboarded to the smartphone app SiS and will be asked to use it for 7 weeks to support them in quitting smoking.
15839762|NCT04126200|Drug|Isatuximab|Isatuximab will be administered
15772856|NCT04672239|Behavioral|"Smartphone app QuitGuide (QG)"|Participants will be onboarded to the NCI smartphone app QG and will be asked to use it for 7 weeks to support them in quitting smoking.
15772857|NCT04672239|Behavioral|"Brochure Clearing the Air (CTA)"|"Participants will be onboarded to the brochure Clearing the Air and will be asked to use it for 7 weeks to support them in quitting smoking."
15772858|NCT04672226|Dietary Supplement|PDE MAX|PDE MAX will be prescribed by the study dietitian based on the patient's individual requirement.
15772859|NCT04672213|Drug|Tranexamic acid|Intravenous or oral tranexamic pre- and/or postoperatively
15772860|NCT04672200|Other|Group exercise|Weekly group exercises delivered online and face to face
15772861|NCT04672174|Diagnostic Test|Questionnaire: DemTect|Questionnaire is handed out to subjects
15772862|NCT04672161|Other|Vaccine Education|A baseline educational intervention on vaccination and its role in the health maintenance of patients with IBD will be provided to all participants. Those on immunosuppressive therapies and/or those age 65 or older will also be offered the pneumonia vaccine educational intervention. Finally, patients aged 18-26 and those 27-45 who have never been vaccinated for HPV or those with high risk for HPV will additionally receive the HPV educational intervention.
15772863|NCT04672135|Drug|REM0046127|Oral solution: 100 mg/mL REM0046127
15772864|NCT04672135|Drug|Placebo|Oral solution with 0 mg/mL REM0046127
15772866|NCT04672109|Device|Transcranial direct current stimulation|Dual/Cathodal/Anodal/Sham tDCS will be applied in 2 mA, 20 mins. All experiments will be performed in random order for each subject.
15772867|NCT04672096|Device|Neuronoff BASMATI Injectrode|The 28 day temporary placement of a Basmati Injectrode does not result in unexpected levels of inflammation or encapsulation.
15772868|NCT04672083|Drug|CPT31|CPT31 (cholesterol-PIE12-2-trimer) is a novel D-peptide HIV entry inhibitor that binds with high affinity to a conserved hydrophobic pocket within the gp41 trimer
15772869|NCT04672083|Drug|Placebo|matching placebo
15772870|NCT04672070|Other|Selective Caries Removal|"Selective caries are removed only for secure sealing with a direct restoration, without removing deep caries next to the pulp.
~If the pulp is exposed, pulpotomy will be performed instead and the tooth will be excluded from further analysis."
15772871|NCT04672070|Other|Pulpotomy|"Complete caries removal and excision of the coronal pulp to the level of the root canal orifices will be performed. After haemostasis, sealing with Biodentine® and restoration.
~If the pulp is not exposed after complete caries removal, the tooth will be restored without further excavation and pulp exposure. If the pulp is assessed intra-operatively to be non-vital or not amenable to pulpotomy, root canal treatment will be performed instead. In both cases, the tooth will be excluded from further analyses."
15772872|NCT04672057|Other|assessment of gait parameters|Gait parameters have been recourded with the use of BTS G-Walk Wireless Digital Walking Analysis System on a 10-meter smooth walking area.
15772875|NCT04672031|Other|Glycemic Targets|The intervention is glycemic targets that are lower than those currently recommended by ADA and ACOG: fasting ≤80 mg/dL, pre-prandial ≤80 mg/dL, and 1-hour postprandial ≤110 mg/dL instead of fasting ≤95 mg/dL, pre-prandial ≤95 mg/dL, and 1-hour postprandial ≤140 mg/dL.
15772876|NCT04672018|Combination Product|Houtou Jianweiling tablet,|The raw materials of Houtou Jianweiling Tablet are safe and effective. It has been used and marketed in China for nearly 20 years without toxic reactions and adverse events. The composition of the prescription conforms to the theory of traditional Chinese medicine and is supported by 20 years of clinical application experience.
15772877|NCT04672005|Drug|Folfirinox alternating with Gemcitabine-nab-Paclitaxel|modified Folfirinox every 2 weeks and biweekly Gemcitabine plus Nab-Paclitaxel
15772878|NCT04671992|Device|Out of-Plane Technique and In-Plane on|A comparison of out of-plane technique and in-plane
15772879|NCT04671979|Diagnostic Test|Lactate Dehydrogenase|All the patients that arrived at the hospital with symptoms of mesenteric ischemia, had a registered lactate dehydrogenase. We compared the value with the patient's outcomes.
15772880|NCT04671966|Drug|Estradiol patch|Brand name Climara for estrogen add back portion of study. Premenopausal women treated with a GnRH antagonist will be randomized to estrogen add-back or placebo. Thus, for women without contradictions to estrogen use, the risks associated with their use for the duration proposed in these studies (i.e., 6 days) are small. The respective estradiol regimen is a standard approved dose for treatment of hot flashes and the prevention of osteoporosis, and this dose will increase E2 to concentrations typically observed during the mid to late follicular phase of the menstrual cycle.
15772881|NCT04671966|Drug|Cetrotide|Premenopausal women will be treated with the gonadotropin-releasing hormone (GnRH) antagonist Cetrorelix for 6 days in order to suppress ovarian sex hormones. Cetrorelix may cause an anaphylactic reaction in volunteers with hypersensitivity to cetrorelix, GnRH or any other GnRH analogs, or extrinsic peptide hormones or mannitol. It may also cause hot flashes, headaches, and nausea. These are typically transient and of mild intensity. These effects are all reversible upon cessation of cetrorelix. Absence of pregnancy will be confirmed before drug administration.
15772882|NCT04671966|Other|Fasting|Subjects will abstain from food for 48 hours. Subjects will be allowed water and/or an isotonic saline solution in order to maintain hydration status.
15772883|NCT04671966|Other|Lower Body Negative Pressure|This test simulates Earth's gravity. The subject will rest on his/her back, with their lower body sealed in an air-tight chamber from the waist down. The chamber is connected to a vacuum that sucks air from the chamber and creates negative pressure inside and around the subject's lower body. As a result, the subject's blood pool shifts towards their legs, away from their chest and arms.
15772884|NCT04671953|Drug|BMS-986165|Specified dose on specified days
15772885|NCT04671953|Drug|Metformin|Specified dose on specified days
15772886|NCT04671940|Other|DNA Analysis|Molecular analysis includes DNA analysis on the blood/saliva and on the cancer specimens from the biopsies & subsequent resections
15772887|NCT04671914|Drug|Hyaluronic Acid 20 MG/ML Injectable Solution|Application of hyaluronic acid gel into uterine cavity after After abortion in II trimester we do D&C
15772888|NCT04671914|Other|Dilation and curretage|After abortion in II trimester we do D&C.
15772889|NCT04671901|Drug|Romiplostim|Participants will receive weekly doses of romiplostim, beginning with cycle 4. The initial romiplostim dose will be 3 mcg/kg, with subsequent doses titrated per protocol for a target of platelet count > 75,000- 200,000/mcL. Participants will continue romiplostim until completion of N8 or EFT, as defined above. Maximum romiplostim dose is 10 mcg/kg. Participants will be followed until 6 months after the last dose of romiplostim.
15772890|NCT04671888|Other|exercises|COPD patients will be asked to wear a data logger system to collect EMG data and respiration parameters during exercise that simulate daily activity (i.e., walking, cycling)
15772891|NCT04671875|Drug|Recombinant Humanized Monoclonal Antibody MIL93|"PART I :The patients confirming to the eligibility criteria will be assigned to the 6 dose groups (0.3mg/kg, 1mg/kg, 3mg/kg, 10mg/kg, 20mg/kg, 30mg/kg,respectively) based on the sequence of inclusion. Each patient will receive an intravenous infusion of MIL93 every 3 or 2 week on Day 1.
~PART II:One recommended dose will be conducted from 6 dose groups based on results of PART I."
15772892|NCT04671862|Device|Photobiomodulation|"Parameters: combined 633nm and 870 nm @1000mW
~1 Treatment 4J continuous prior to RT. (Within 14 days of RT start)
~3 treatments weekly during RT (6 J at 12 Hz, 80% duty cycle)"
15772893|NCT04671849|Drug|SIM1803-1A|SIM1803-1A will be administered orally as tablets at a given dose once daily in continuing 21-days cycles.
15772894|NCT04671836|Drug|Lorazepam 1Mg Tablet|"1 mg, white, five-sided (shield shape) tablet with a raised A on one side and BPI and 64 impressed on scored reverse side. NDC 0187-0064-01 - Bottles of 100 tablets; NDC 0187-0064-50 - Bottles of 500 tablets; NDC 0187-0064-10 - Bottles of 1000 tablets.
~The pharmacy at the Zucker Hillside Hospital will encapsulate both lorazepam 1 mg and placebo pills to make them look the same. On the day of the scan, the research coordinator or the PI will pick up the blinded study medication (lorazepam or placebo) and will administer it to the participant. One hour later, the participant will be placed in the scanner to complete the MRI."
15772895|NCT04671836|Drug|Placebo|Placebo will be purchased and encapsulated by the pharmacy at the Zucker Hillside Hospital.
15772896|NCT04671810|Biological|Elizaria®|Elizaria® will be prescribed by the Physician according to the actual SMPC.
15772897|NCT04671797|Behavioral|Early dinner|Dinner at DLMO-3, sleep at DLMO+2
15772898|NCT04671797|Behavioral|Late Dinner|Dinner at DLMO+1, sleep at DLMO+2
15772899|NCT04671797|Behavioral|Late Dinner + Late Sleep|Dinner at DLMO+1, sleep at DLMO+6
15772900|NCT04671784|Other|EUS-E|EUS-E
15772901|NCT04671771|Device|InnAVasc arteriovenous graft surgical implant|The InnAVasc AVG is a hemodialysis vascular access graft, intended for implantation in the lower or upper arm using standard vascular techniques, in patients requiring hemodialysis
15772902|NCT04671745|Behavioral|Music|patient receiving care with interactive music
15772903|NCT04671745|Behavioral|No music|patient receiving care without interactive music
15772904|NCT04671732|Procedure|Fenestrated endovascular aortic aneurysm repair|Fenestrated endovascular aortic aneurysm repair consists in excluding a juxtrenal or suprarenal aneurysm by deploying a covered stent (stent graft) in the aorta so as to created sealing zones on both sides of the aneurysm. Since the proximal sealing is located in the visceral segment of the aorta, fenestrations are created to maintain blod flow in renal and visceral arteries. These fenestrations are custom made for each patient. Brindging covered stents are deployed between each fenestration and corresponding target arteries in order to insure sealing of the system.
15772905|NCT04671732|Procedure|open repair of abdominal aortic aneurysm.|Open repair of abdominal aortic aneurysms consists in cross-clamping the aorta on both sides of the aneurysm and replace the diseased segment by a prosthetic graft.
15772906|NCT04671719|Biological|blood sample|blood sample for circulating autotaxin measurement (5ml).
15772907|NCT04671693|Other|PASCA intervention|"At each study visit (T1 = 1 month, T2 = 6 months, T3 = 24 months, T4 = 60 months), an exhaustive screening of complications as well as associated sub-clinical abnormalities and risk factors previously identified as such in the literature, will be conducted.
~Management of complications consists of referring the patient to a healthcare professional belonging to the PASCA network based on the test results. Referral is defined by referring to pre-established decision trees. It is made to a specialist physician, a health professional from the paramedical field or the patient's general practitioner who confirms the diagnosis if necessary and initiates the patient's care and follow-up. These patients also receive their usual follow-up in the context of their tumor pathology in oncology and onco-hematology."
15772908|NCT04671680|Device|LiDCO CNAP Monitoring Equipment|A continuous non-invasive arterial blood pressure monitor for rapidly changing hemodynamics.
15772914|NCT04671641|Device|radiofrequency ablation|ultrasound-guided radiofrequency ablation is performed to treat varicose veins patients
15772915|NCT04671628|Behavioral|Relaxing music|Participants will be asked to listen to relaxing music for 30 minutes each day. They will allowed to choose between several playlists based on their preference.
15772916|NCT04671615|Drug|palbociclib|As provided in real world practice
15772917|NCT04671589|Drug|Meropenem Injection|"Administration Intravenous meropenem 1gram every 8 hours together with standard care;
~."
15772918|NCT04671576|Other|Control Infant Formula|Powder, standard commercial infant formula.
15772919|NCT04671576|Other|Organic Infant Formula|Powder, organic milk-based infant formula.
15772920|NCT04671563|Drug|Tenofovir Disoproxil Fumarate 300 MG|One tablet of Viproof Film Coated Tablets or Viread Tablets will be orally administrated with 240 mL of water in the morning.
15772921|NCT04671550|Diagnostic Test|questionnaire|"Questionnaire on Driving performances and Visual Field"
15772922|NCT04671537|Drug|Preloading with crystalloid fluid|crystalloid fluid at 10 ml/kg of ideal body weight was administered intravenously in 30 min before the BCP for patients
15772923|NCT04671524|Other|Exercise protocol|a combination of stretching, range of motion, and strengthening exercise.
15772924|NCT04671511|Procedure|Targeted Axillary Dissection|Sentinel Node Biopsy (SNB; using Tc99 +/- Blue dye) + Radioactive Seed Localisation (RSL) of clipped node using I125 seed = Targeted Axillary Dissection (TAD)
15774577|NCT04658524|Diagnostic Test|Thyroid function|laboratorial thyroid tests
15772925|NCT04671511|Diagnostic Test|Ultrasound of the axilla|Prospectively recorded preoperative ultrasound of the axilla. Number of suspicious nodes recorded. Biopsy and clipping of the positive node.
15772926|NCT04671498|Procedure|Biospecimen Collection|Undergo collection of blood sample
15772927|NCT04671498|Procedure|Droplet-BC Test|Undergo Droplet-BC Test
15772928|NCT04671498|Other|Electronic Health Record Review|Medical records are reviewed
15772929|NCT04671485|Other|Standard care|Patient undergoing radiotherapy for head and neck tumor with a compression mask, and assessed as anxious about wearing this mask will have standard care
15772930|NCT04671485|Other|Autohypnosis|"The patient will be called to learn autohypnosis during a specific consultation, with a radiotherapy manipulator trained to learn this technic.
~The patient will use this technic during the centering scanner and the first 5 radiotherapy sessions"
15772931|NCT04671485|Other|Musicotherapy|"the patient will choose the music he want to listen from a music database (3 specific moods).
~The chosen music will be broadcast to the patient via a hi-fi system present in the treatment room during the centering scanner and for the first 5 radiotherapy sessions"
15772932|NCT04671472|Drug|NPC-09|The drug will be administered by the oral route with the same manner
15772933|NCT04671472|Drug|NPC-09 placebo|The drug will be administered by the oral route with the same manner
15772934|NCT04671459|Combination Product|TTFields and SRS|SRS procedure will be delivered within 7 days after start of TTFields therapy . A 5-day SRS regimen is allowed. TTFields should be interrupted in time of SRS and start immediately after.
15772935|NCT04671446|Diagnostic Test|Autoantibody ELISA|Serum will be tested for novel autoantibodies against eosinophil proteins by ELISA, such as those previously identified as of importance (e.g. eosinophil-peroxidase, EPX) and also novel candidate proteins specific to eosinophils (including ARFIP1, BCL2A1, PPCDC, SLC12A6 etc) as identified by FANTOM5 geneset analysis.
15772936|NCT04671433|Biological|Genetic: AAV5-RPGR|Bilateral, sub-retinal administration of AAV5-RPGR - immediate treatment group
15772937|NCT04671433|Biological|Genetic: AAV5-RPGR|No intervention - deferred treatment group (Bilateral, sub-retinal administration of AAV5-RPGR to be administered in the follow-up study)
15772938|NCT04671420|Drug|HLX01|Patients will receive HLX01 intravenous (IV) infusion once a week for 4 weeks induction treatment (on Days 1, 8, 15, and 22), and then continue to receive maintenance treatment at Weeks 12, 20, 28, 36, and 44.
15772939|NCT04671420|Drug|Mabthera®|Patients will receive Mabthera® intravenous (IV) infusion once a week for 4 weeks induction treatment (on Days 1, 8, 15, and 22), and then continue to receive maintenance treatment at Weeks 12, 20, 28, 36, and 44.
15772940|NCT04671407|Drug|Hypertonic Saline|Hypertonic Saline 3% and 0.9%
15772941|NCT04671394|Procedure|FMUD + DLIG|Full-Mouth Ultrasonic Debridement + Diode Laser and Indocyanine Green solution
15772942|NCT04671394|Procedure|FMUD + ST|Full-Mouth Ultrasonic Debridement + Sham Treatment
15772947|NCT04671368|Diagnostic Test|Artificial Intelligence|The investigators will use the Artificial Intelligence Diagnostic System to review the H＆E stained slide of each patient and then report the classification of the tumor on a 10-type scale.
15772948|NCT04671368|Diagnostic Test|Practicing Pathologists|The ordinary pathologist will review the H＆E stained slide of each patient(without additional informations such as: Immunohistochemistry et al.) and then report the classification of the tumor on a 10-type scale only bases on the slide images
15772949|NCT04671368|Diagnostic Test|Gold Standard|Firstly, the two expert pathologist(>=10 years of experience) will review the H＆E stained slide of each patient on their own (with additional informations such as: Immunohistochemistry et al.) and then report the classification of the tumor on a 10-type scale.If they report the same opinion, that opinion will perform as the ground truth; while if their opinion clash with each other, the expert pathologist(>=15 years of experience) will get involved and the agreement of three experts will perform as the ground truth
15772950|NCT04671355|Drug|Beclometasone Dipropionate / Formoterol Fumarate / Glycopyrronium 100/6/10 mcg|Pressurized metered dose inhaler
15772951|NCT04671355|Drug|Fluticasone Furoate / Vilanterol Trifenatate 100/25 mcg|Dry powder inhaler
15772953|NCT04671329|Device|Affirm Contrast Biopsy procedure|Contrast Enhanced Digital Mammography (CEDM) is an extension of the existing indication for diagnostic mammography with the Selenia Dimensions system and 3Dimensions system. Biopsy targeting can be done on captured contrast enhanced images (scout and stereo pair). The CEDM application shall enable contrast enhanced breast imaging using a dual energy technique. This imaging technique can be used as an adjunct following mammography and/or ultrasound exams to localize a known or suspected lesion. Affirm Contrast Biopsy is intended for patients recommended for biopsy who have had a suspicious finding on previous contrast enhanced imaging or have lesions that may be occult under other modalities.
15772954|NCT04671316|Drug|DA-5209 60mg Tab|"single oral administration of 1 tablet of DA-5209 60mg Tab with 150mL water"
15772955|NCT04671316|Drug|DA-5209 60mg Tab|"single oral administration of 1 tablet of DA-5209 60mg Tab without water"
15772956|NCT04671316|Drug|Lixiana 60mg Tab|"single oral administration of 1 tablet of Lixiana 60mg Tab with 150mL water"
15772957|NCT04671303|Drug|Anlotinib Hydrochloride Capsule Combined with Allitinib Tablets|"Anlotinib Hydrochloride Capsule: Oral on an empty stomach, once a day, 1 capsule each time, orally for 2 consecutive weeks, stop for 1 week Allitinib Tablets：The dose of allitinib mesylate is 80 mg once a day, 2 tablets each time, taken orally on an empty stomach before breakfast.
~Take medicine continuously for 3 weeks (21 days) for 1 cycle."
15772958|NCT04671290|Other|Any intervention|No intervention
15772959|NCT04671277|Other|Chewing of breads|"During the video recording session, participants were asked to place the whole sample (5-6 g) in the mouth (e.g. single bite) and chew naturally until the bolus is ready for swallowing.
~During the second section, participants were asked to place the whole sample in the mouth and chew naturally. After 5 chewing cycles, participants checked all the attributes that describe the texture sensations perceived at the beginning of mastication. A list of attributes and their definitions were provided to guide the participants. Participants proceeded with chewing until the swallowing point when they again checked all the attributes that characterize the texture sensations perceived at the end of mastication. The food bolus was then spat in a container."
15772960|NCT04671264|Device|Sallowing VC during six weeks|"follow-up was required for at least 6 times, once every two weeks through the whole study.
~For patients who had no colonoscopy examination within a year, colonoscopy was a must to exclude organic diseases.
~These included blood routine, blood biochemistry, urine routine, fecal routine, fecal occult blood, thyroid stimulating hormone (TSH), blood pregnancy test and ECG examination. Patients should finish all the examination in the run-in period and at the end of treatment period.
~Dairy cards were designed mainly for the record of the daily defecation of patients and filled out by the enrolled patients, and the content included date, whether the patients swallow capsules (time), whether the patients discharge capsules (time), defecation, defecation time, degree of defecation exertion(0~4), BSF scale, complete or incomplete defecation, whether the patient had the sense of anal obstruction, whether manual assistance was applied, and whether first-aid medicine was used (bisacodyl)."
15772961|NCT04671251|Drug|AEVI-007|50 mg of AEVI-007 and will be reconstituted with 1.2 mL of water for injection.
15772962|NCT04671238|Device|SPECT CT|SPECT/CT scan of the spine as part of a vertebroplasty
15772963|NCT04671225|Behavioral|Groups Psychoeducation|Manual-structured group psychoeducation with 8 sessions of 90 minutes over the course of 8 weeks (at one session per week). The manual is centred on behavioural principles from social education and self-regulation philosophies. All groups will have 6-8 participants and two health professionals to conduct the sessions; a psychiatric nurse and either a psychologist or a psychiatric resident. Patients will be offered to invite their relatives for 2-3 psychoeducation-days for relatives.
15772964|NCT04671225|Behavioral|Waiting-list|Participants in the control group will be assigned to a waiting list and receive group-psychoeducation after the active intervention groups.
15772965|NCT04671199|Other|MP 3000 monitor|Additional monitoring
15772966|NCT04671186|Dietary Supplement|Culturelle (Lactobacillus rhamnosus strain GG)|Culturelle probiotics are typically sold over the counter as dietary supplements Probiotics group will take 1 capsule of probiotics orally once daily
15772967|NCT04671186|Other|Placebo|Placebo group will take 1 capsule of placebo orally once daily
15772968|NCT04671173|Device|Measurement of the Intra-Compartmental Pressure with the MY01 device|"All Participants will be monitored for clinical signs of symptoms of ACS, including the 7 Ps at a minimum of every 4-6 hours.
~The Intra-Compartmental Pressure of the anterior compartment of the leg will be monitored with the MY01 device. The device should be inserted five centimeters (5 cm) from the fracture, if possible, in the muscle belly. The affected limb will then be splinted in a standard U-slab with no pressure on the monitored device."
15772969|NCT04671160|Diagnostic Test|Assessment the activity of anti-Xa factor.|Assessment the activity of anti-Xa factor in patients treated with CVVHDF and receiving enoxaparin as anticoagulant prophylaxis, patients treated with CVVHDF and receiving fondaparinux as anticoagulant prophylaxis, patients not treated with CVVHDF and receiving enoxaparin as anticoagulant prophylaxis and patients not treated with CVVHDF and receiving fondaparinux as anticoagulant prophylaxis.
15772970|NCT04671147|Procedure|Preoperative traction|Compare two methods of preoperative traction (Cotrel traction exercises and skull tongs femoral traction)
15772971|NCT04671134|Other|Biomimetic remineralizing agent|Self-assempling peptide
15772972|NCT04671134|Other|Resin Modified Glass Ionomer Varnish|Resin Modified Glass Ionomer Varnish
15772973|NCT04671121|Procedure|Standart pressure pneumoperitoneum|CO2 insufflation pressure was kept at 14 mmHg throughout the surgery.
15772974|NCT04671121|Procedure|Low pressure pneumoperitoneum|CO2 insufflation pressure was kept at 8 mmHg throughout the surgery.
15772975|NCT04671108|Device|Hioxifilcon A standard hydrogel contact lens with Hyaluronic Acid (HA)|Daily disposable contact lens wear for 1 week
15772976|NCT04671095|Device|ERCP procedure with single use duodenoscope|ERCP is an endoscopic procedure done to relieve bile duct obstruction. It is done either under conscious sedation or deep sedation. The endoscope is inserted thorough the mouth and is taken to the second part of duodenum (small bowel). The ampulla is identified and the bile duct is cannulated. Biliary obstruction is relieved either by placing a stent or removing the stone/s
15772979|NCT04671069|Drug|MGL-3196|Administered orally on the morning of Day 1; Multiple-dose administration of 100 mg MGL-3196 on Day 6 until Day 14
15772980|NCT04671069|Drug|Clopidogrel|After one-day washout period after Day 1, loading dose of 300 mg clopidogrel administered on Day 3 and then, at approximately the same time each morning, 75 mg clopidogrel administered on Days 4 to 11
15772981|NCT04671056|Drug|MGL-3196|MGL-3196 100 mg tablet administered orally in the morning for 13 days
15772982|NCT04671056|Drug|Pioglitazone 15mg|Pioglitazone 15 mg tablet administered orally on 2 separate days, initially on one day alone and again after MGL-3196 has been dosed to steady-state
15772983|NCT04671043|Dietary Supplement|Caffeine and glucose|Caffeine and glucose powder dissolved in water
15772984|NCT04671043|Dietary Supplement|Glucose alone|Glucose powder dissolved in water
15772985|NCT04671043|Dietary Supplement|Placebo|Artificial sweetener dissolved in water
15772986|NCT04671030|Drug|Neostigmine and Glycopyrrolate|Intravenous followed by transdermal administration of the two drug combination.
15772987|NCT04671030|Device|Iontophoresis|Application of direct current to skin using an FDA-approved device
15772989|NCT04670991|Radiation|EXATRAC imaging|Exatrac imaging performed before the standard CBCT imaging prior to each chemotherapy session
15772990|NCT04670978|Drug|albumin-bound paclitaxe combined with bevacizumab biosimilar|albumin-bound paclitaxe, 260mg/m2, every 3 weeks, 6cycles, bevacizumab biosimilar, 10mg/kg, every 3 weeks, continue until PD or unaccceptable toxicity
15772991|NCT04670965|Biological|E-PRF/rhBMP-2 (similar ratios)|During its preparation, 1.5 mg/ml rhBMP-2 will be incorporated into standardized samples to assure similar E-PRF to rhBMP-2 ratios. To allow for consistency across all samples, standardized E-PRF volume will be established using formation templates. Following its preparation, the E-PRF/rhBMP2 scaffold will undergo a standard in vitro assay to investigate growth factor release over time (ELISA quantification assay). Briefly, the e-PRF/rhBMP2 scaffold will be placed in a shaking incubator at 37 degree Celsius and assessed for growth factor release of rhBMP-2 over time.
15772992|NCT04670965|Biological|E-PRF/ACS/rhBMP-2|rhBMP-2 diluted to account for the additional volume from the E-PRF in other samples will be loaded onto lyophilized absorbable collagen sponges as per the package insert. After the addition of the rhBMP-2, the ACS will be cut into 2mm x 2mm pieces and incorporated into the E-PRF membrane. Following its preparation, rhBMP-2 release from the E-PRF/ACS/rhBMP2 scaffold will be quantified using the ELISA quantification assay as described above.
15772993|NCT04670965|Biological|rhBMP-2/E-PRF|rhBMP-2 diluted to account for the additional volume from the E-PRF in other samples will be loaded onto lyophilized absorbable collagen sponges as per the package insert. Rh-BMP2 release will be quantified using the ELISA quantification assay as described above
15772994|NCT04670965|Biological|E-PRF only|E-PRF will be prepared and standardized, but no rhBMP-2 will be added to the material. After preparation, the E-PRF scaffold assayed via ELISA quantification assay as described above to determine the release (if any) of intrinsic BMP-2 from the platelet concentrate scaffold.
15772995|NCT04670952|Other|Low Pressure Laparoscopic Cholecystectomy|Low Pressure Laparoscopic Cholecystectomy (10mmHg) is set as the experimental group.
15772996|NCT04670952|Other|Standard Pressure Laparoscopic Cholecystectomy|Standard Pressure Laparoscopic Cholecystectomy (14mmHg) is set as the control group.
15772997|NCT04670939|Procedure|breath exercises|diaphragmatic breathing exercise that used during weaning is the respiratory physiotherapy
15772998|NCT04670926|Diagnostic Test|TruGraf|"TruGraf results will be available in real-time and used by the physician in conjunction with other standard of care labs to guide management of immunosuppression as follows:
~Patients with a stable serum creatinine and eGFR of > 45 mL/min who also have a TruGraf TX result at month 3 will have their Mycophenolate Mofetil or Mycophenolate Sodium decreased from a standard dose of 1000 mg twice daily to 500 mg twice daily or 720 mg twice daily to 360 mg twice daily respectively.
~Patients with a stable serum creatinine and estimated eGFR of > 45 mL/min who also have a TruGraf TX result at months 4, 5, and 6 will have their Tacrolimus target trough level decreased to a target between 3 and 6.
~Patients with TruGraf not-TX will have no further immunosuppression reduction and continued to be monitored."
15772999|NCT04670926|Other|Standard of Care|Patient's immunosuppression will be managed per the current CPMC standard of care that includes continuation of Mycophenolate Mofetil or Mycopheonolate Sodium at 1000 mg bid or 720 mg bid respectively. The dose may be decreased at the discretion of the physician for drug adverse effects such as diarrhea or other gastrointestinal side-effects or neutropenia as is the standard of care. Patients will be maintained on Tacrolimus at target levels that are considered standard of care by the managing physician.
15773000|NCT04670913|Drug|Camrelizumab|A human anti-PD-1 monoclonal antibody
15773001|NCT04670913|Drug|Apatinib|A tyrosine kinase inhibitor selectively targeting VEGFR-2
15773002|NCT04670900|Procedure|Tension band wiring or plate fixation|Choice of operative treatment is TBW or PF with a precontoured anatomical plate. The treating surgeon decides if TBW or PF is chosen as operative treatment method. The surgeries are performed according to OTA principles by an experienced surgeon, a trauma fellow or a consultant as approved by the participating hospitals.
15773003|NCT04670900|Procedure|Active non-operative treatment with optional plaster cast|Patients allocated to non-operative treatment are offered a back-slab in 60 degrees of flexion for pain-relief. The back-slab is removed 7-14 days following injury.
15773004|NCT04670887|Procedure|Delayed surgery|Delayed surgery is performed if cystic mass radiologically upgrades into Bosniak 4 or solid mass in the active surveillance.
15773005|NCT04670887|Procedure|Immediate surgery|Partial or radical nephrectomy is performed as treatment of Bosniak 3 cystic mass
15773006|NCT04670874|Other|Quality-of-Life Assessment|Complete quality of life questionnaire
15773007|NCT04670874|Other|Questionnaire Administration|Complete quality of life questionnaire
15773008|NCT04670861|Procedure|Upper extremity Biodex balance training|"The person assumes the prone plank posture with both hands poisoned in the area assigned for foot placement on the tilting balance platform. Using the four keypads, the person's left hand, left wrist, right hand and right wrist positions are entered into the system using the midline of the hand and the platform grid as reference points. The dot that appears on the position patient screen represents the person's segmental center of gravity.
~During each trial test, the person should shift his weight to move the cursor from the center along a target path and back as quickly and with a little deviation as possible. The same process is repeated for each of the targets. Target paths activate in a random order."
15773009|NCT04670848|Device|Sleepiz One+ vs. polysomnography|Simultaneous sleep recording with polysomnography and Sleepiz One+ device
15773012|NCT04670809|Drug|Clevidipine Butyrate Injection|Initiate the intravenous infusion of Clevidipine Butyrate Injection at 2 mg/hour. The dose should be doubled every 3 minutes in the first 30 minutes if the desired blood pressure reduction (≥15% and ≤25%) is not achieved and the maximum dose is 32 mg/hour. The infusion duration should be at least 12 hours and less than 72 hours. Oral antihypertensive drugs should be given at about 2 hours before stopping infusion.
15773013|NCT04670809|Drug|Ncardipine Hydrochloride Injection|Dilute the Ncardipine Hydrochloride Injection to 0.1mg/ml. Initiate the intravenous infusion at 0.5μg/(kg•min). A 0.5-1μg/(kg•min) dose should be added every 3 minutes in the first 30 minutes if the desired blood pressure reduction (≥15% and ≤25%) is not achieved and the maximum dose is 6μg/(kg•min). The infusion duration should be at least 12 hours and less than 72 hours. Oral antihypertensive drugs should be given at about 2 hours before stopping infusion.
15773014|NCT04670796|Drug|HLX02|subject receive one dose of HLX02
15773015|NCT04670796|Drug|EU-sourced Trastuzumab (Herceptin®)|subject receive one dose of EU-sourced Trastuzumab (Herceptin®)
15773016|NCT04670796|Drug|US-licensed Trastuzumab (Herceptin®)|subject receive one dose of US-licensed Trastuzumab (Herceptin®)
15773017|NCT04670783|Procedure|Surgery|Orthopedic surgery (i.e. tenotomy, tendon transfer) or percutaneous neuroablative procedures (i.e. cryoneurotomy) which will be done for upper limb refractory spasticity after being triaged by DNB.
15773019|NCT04670757|Drug|CPL409116|IMP administration, tablets contain CPL409116 as an active ingredient
15773020|NCT04670757|Drug|Placebo|Placebo comparator
15773021|NCT04670718|Device|Optical Coherence Tomography Probe|Use of OCT probe for examination of gastrointestinal tract
15773022|NCT04670705|Other|patients' characteristics|There was no intervention.
15773023|NCT04670692|Other|5G-MCE examination|The endoscopist (W.Z.) manipulated the two joysticks on the remote console (based in Shanghai). Then the remote control software and remote connection software takes the endoscopist's input and translates it into a control signal. After network transmission, the patient side cart (based in Yinchuan) translates the control signal into actual instrument manipulation and mobilize the robotic magnetic arm, and simultaneously driving the precise movement and rotation of the capsule to perform the gastric and duodenum examination. Meanwhile, the images captured by the capsule are simultaneously sent back to the screen of the remote console, and thus provide guidance for better control of the capsule.
15773024|NCT04670692|Other|MCE examination|The endoscopist (W.Z.) performs the MCE examination procedure conventionally. And communicate with the volunteer face to face in the same examination room.
15773025|NCT04670679|Drug|ERAS-601|Administered orally
15773026|NCT04670679|Drug|Cetuximab|Administered via intravenous infusion
15773027|NCT04670666|Drug|MADALENA ASSOCIATION|Madalena association coated tablet.
15773028|NCT04670666|Drug|METFORMIN|Metformin 1000 mg extended-release tablet.
15773029|NCT04670666|Drug|EMPAGLIFLOZIN + LINAGLIPTIN|Empagliflozin 10 mg + linagliptin 5 mg coated tablet.
15773030|NCT04670666|Other|MADALENA ASSOCIATION PLACEBO|Madalena association placebo tablet.
15773031|NCT04670666|Other|METFORMIN PLACEBO|Metformin placebo tablet.
15773032|NCT04670666|Other|EMPAGLIFLOZIN + LINAGLIPTIN PLACEBO|Empagliflozin + linagliptin placebo tablet.
15773033|NCT04670653|Drug|MAGNÓLIA NASAL GEL|Magnólia nasal gel spray
15773034|NCT04670653|Drug|MOMETASONE FUROATE|Mometasone furoate nasal spray
15773035|NCT04670640|Device|Vibration|Participants will attend two intervention sessions per week for a total of 8 sessions. Participants will sit in a chair in a sound-proof booth monitored by a researcher in front of a computer screen (which delivers instructions) and will be fitted with psychophysiology leads and a device strapped around the chest. There will be no explicit tasks or direction given in this intervention. Participants will experience smooth slowly varying breath-like vibration on their sternum. They will receive their assigned intervention for approximately 18 minutes.
15773036|NCT04670640|Behavioral|Breath Focus|Participants will attend two intervention sessions per week for a total of 8 sessions. Participants will sit in a chair in a sound-proof booth monitored by a researcher in front of a computer screen (which delivers instructions) and will be fitted with psychophysiology leads and a device strapped around the chest. The participant will be asked to focus on their breathing during this intervention. They will receive their assigned intervention for approximately 18 minutes.
15773037|NCT04670640|Behavioral|No Distractions|Participants will attend two intervention sessions per week for a total of 8 sessions. Participants will sit in a chair in a sound-proof booth monitored by a researcher in front of a computer screen (which delivers instructions) and will be fitted with psychophysiology leads and a device strapped around the chest. Participants will engage in a period of no-screen time; during this time there will be no outside visual or auditory distractions. There will be no explicit tasks or direction given in this intervention. They will receive their assigned intervention for approximately 18 minutes.
15773038|NCT04670614|Procedure|Nerve Block with ropivicaine 0.5% Injectable Solution|Peripheral nerve blocks using 0.5% ropivicaine
15773039|NCT04670614|Procedure|Nerve Block with Placebo sham control of 0.9% Normal Saline|Peripheral Nerve Block with placebo 0.9% normal saline
15773040|NCT04670601|Drug|Flurbiprofen Test 8.75 MG|Subjects will be asked to swallow saliva before dosing. For each administration, subjects will move the lozenge around in their mouth, suck on the lozenge continually for 15 min and swallow saliva at any time during the product administration procedures, being very careful not to swallow the lozenge.
15773041|NCT04670601|Drug|Flurbiprofen Reference 8.75 MG|Subjects will be asked to swallow saliva before dosing. For each administration, subjects will move the lozenge around in their mouth, suck on the lozenge continually for 15 min and swallow saliva at any time during the product administration procedures, being very careful not to swallow the lozenge.
15773042|NCT04670588|Diagnostic Test|Circulating tumor DNA(ctDNA) level measurement|The ctDNA level will be measured using the Signatera platform developed by Natera, Inc. Signatera is a patient-specific, tumor informed custom-built ctDNA monitoring assay.
15773043|NCT04670575|Procedure|Cataract Surgery with Implantation of Vivity Extended Range of Vision IOL|Patients with early stage glaucoma implanted with Vivity or Vivity Toric IOL
15773044|NCT04670549|Other|Implementation of treatment guidelines|To improve knowledge of OA treatment recommendations among people with hip and knee OA, a lay language summary will be emailed all OA patient participants. A second summary of the treatment recommendations, targeting general practitioners (GPs) will also be emailed the OA patient participants. The patients will be encouraged to print and bring this summary to their GP at the next visit (user-initiated implementation). Barriers and facilitators for providing evidence-based OA care among primary care physiotherapists will be mapped through interviews. Thereafter, a tool-kit of strategies and practical aids intended to help overcome these barriers will be developed and made available for the physiotherapists.
15773045|NCT04670536|Device|PASS LP implants|Thoraco lumbar arthrodesis
15773046|NCT04670536|Device|PASS DEGEN|Thoraco lumbar arthrodesis
15773047|NCT04670536|Device|PASS TULIP PRIME|Thoraco lumbar arthrodesis
15773048|NCT04670536|Device|PASS TULIP GENESIS|Thoraco lumbar arthrodesis
15773117|NCT04669912|Other|glucose control and sensor usage|Data related to glucose control and sensor usage collected from the Libreview platform
15773118|NCT04669899|Drug|JTX-8064|Specified dose on specified days
15773049|NCT04670523|Procedure|Early postoperative day 0 (POD 0) chest tube removal.|Chest tube removal is a standard bedside intervention after lung resections. Its time point is normally defined according a traditional standard airleak threshold. Traditionally, in our department this threshold will be respected not earlier than 1 day after the operation. The patients of the study group are getting their chest tube removed according to our current airleak protocol (Flow <20 mL/ min on digital suction device) but already in the operating room after wound closure (POD 0). If airleak is persisting than chest tube removal will be performed according to the traditional protocol not earlier than on postoperative day 1 (POD 1).
15773050|NCT04670523|Procedure|Chest tube removal according to traditional standard protocol not earlier than on postoperative day 1 (POD 1).|Chest tube removal according to traditional standard protocol not earlier than on postoperative day 1 (POD 1).
15773051|NCT04670510|Other|On-site AE|"Participants will attend on-site supervised AE sessions 3 times per week for the first 6 weeks, twice weekly for weeks 7-12; once weekly for weeks 13-18.
~All supervised sessions will start and end with 5-minute warm-up and cool-down and will involve exercise on the treadmill, elliptical, and/or bike. During AE sessions, participants will exercise so that their heart rate is approximately 65% of their peak heart rate and gradually increase the intensity of exercise so that their heart rate is between 70 and 85% of their peak heart rate. All participants will wear heart rate monitors and encouraged to exercise in their target heart rate zone. Supervised AE sessions will gradually increase to 50-minutes per session"
15773052|NCT04670510|Other|At-home AE|Participants will increase at-home AE during the 6-month intervention period with weeks 19-26 occurring entirely at-home. As participants transition to home-based exercise, they will be equipped with a polar heart rate monitor and will be instructed to use this to record average heart rate during each exercise session. On a log sheet, they will record both average heart rate during exercise and average subjective rating of perceived exertion (RPE) during each exercise session.
15773053|NCT04670510|Other|Social Engagement (SE)|To control for the social component of the AE intervention participants in the SE group will be invited to attend at total of 25 in-person group meetings over the course of the 6-month study period.
15773054|NCT04670497|Procedure|bupivacaine 0.5% with 1:200000 adrenaline|regional anesthesia to block lumbar plexus for analgesia of lower limb
15773055|NCT04670484|Other|Wearing Mask|Participants wearing masks as per federal guidelines to prevent Coronavirus spread
15773056|NCT04670471|Drug|Remimazolam|Remimazolam is an intravenous anaesthetic and sedative drug. Remimazolam exhibits its anaesthetic effects via the benzodiazepine binding site at the GABAA receptor.
15773057|NCT04670471|Drug|Remifentanil|Remifentanil is a commonly used opioid in anaesthetic practice. It is a potent and fast-acting analgesic.
15773058|NCT04670458|Other|no intervention|no intervention
15773059|NCT04670445|Other|Educational Video and QPL List|The intervention includes a 15-minute educational video and a 2- page list of suggested questions to review with oncology team about immunotherapy.
15773060|NCT04670445|Other|Usual Care|Surveys
15773061|NCT04670432|Drug|Hydroxyethylrutoside|500 mg film-coated tablet
15773062|NCT04670419|Other|Viral clade|Disease outcomes are compared for patients infected with 2 different clades of a HEV gt 3 infection
15773063|NCT04670406|Behavioral|acceptance and commitment therapy (ACT) combined with psychoeducation|Participants receive 8 weekly sessions, including 6 ACT sessions and 2 psychoeducation sessions, delivered by trained coaches through Zoom videoconferencing.
15773064|NCT04670393|Dietary Supplement|FertyBiotic Woman Plus|4g Myo-Inositol, 421 mg D-Chiro-Inositol, 400 mcg folic acid, 55 mcg selenium, 15 mcg vitamin D, 1,8 mg melatonin,2x109 Lactobacillus rhamnosus, 2x109 Lactobacillus crispatus and 2x109 Lactobacillus plantarum
15773065|NCT04670393|Other|Placebo|400 mcg folic acid
15773066|NCT04670380|Other|Posture and movement analysis during a simulated forceps vaginal operative delivery|It will be request from each volunteer to perform a vaginal operative delivery using a Suzor's forceps on a mannequin. The condition will be standardized (anterior occiput low fetal presentation). Each participant will be equipped with 34 reflecting markers allowing to record their movement using infra red cameras (VICON system).
15773067|NCT04670367|Behavioral|Walk 30mins|aerobic exercise
15773068|NCT04670367|Behavioral|Walk plus Baduanjin|Walk 30mins then Baduanjin 12mins per day, 5 times per week.
15773069|NCT04670367|Other|usual care|routine care
15773070|NCT04670367|Behavioral|Baduanjin|Baduanjin exercise is moderate in intensity and short in duration (a set of Baduanjin takes about 12 minutes). Baduanjin consists of the sitting and standing practicing form. The sitting Baduanjin exercise conforms to the aspects of low-intensity and long-term aerobic activity, which is suitable for the rehabilitation training of patients who are in stable condition during hospitalization. The standing Baduanjin is more suitable for patients with sequential rehabilitation after discharge and can be adjusted based on the patient's condition
15773071|NCT04670341|Other|chewing tapioca pearls in bubble tea drinks|Saliva was collected on the first day before bubble tea consumption (pretest) and on the third day after bubble tea consumption (posttest); collection was conducted in the morning (09:00 a.m.-12.00 p.m.).
15773072|NCT04670341|Other|drink tea without chewing tapioca pearls|Saliva was collected on the first day before drink tea without tapioca pearl (pretest) and on the third day after tea consumption (posttest); collection was conducted in the morning (09:00 a.m.-12.00 p.m.).
15773073|NCT04670328|Diagnostic Test|not required|Diagnostic tests( hematological parameters) were assessed.
15773074|NCT04670315|Diagnostic Test|Telematic evaluation of motor function|Validation of the Telematic Spanish Version of the Fugl Meyer Assessment Scale
15773075|NCT04670302|Procedure|Tendon repair procedure|"Tendon repair procedure:
~Single senior surgeon (HS) will perform mini-open surgery to decompress the acromioplasty and repair the supraspinatus tendon.
~Splicing is achieved by installing screw-type anchors on the insertional footprint of the humeral head greater tuberosity.
~Then, double suturing of the supraspinatus tendon is performed."
15773076|NCT04670302|Procedure|Tendon repair augmented with AAdMSC-HAM composite|After double suturing of the supraspinatus tendon, the composite comprising freeze-dried HAM (2 cm x 2 cm x 0.002 cm) and AAdMSC (20 million cells) is placed on the upper surface of the splice and fixed with stitches at all four corners.
15773077|NCT04670289|Drug|TenoMiR (Low Dose)|Mimic of miR29a
15773078|NCT04670289|Drug|TenoMiR (Medium Dose)|Mimic of miR29a
15773079|NCT04670289|Drug|TenoMiR (High Dose)|Mimic of miR29a
15773081|NCT04670276|Procedure|injection of emulsified adipose tissue stromal vascular fraction|Endoscopic injection of 10 cc of autologous microfat into the fistula (through a 6-French catheter), until it was completely filled, and a total of 1-2 cc of tSVFem (through a 22G endoscopic needle) into the submucosa of the 4 quadrants of the fistula borders, to obliterate it completely.
15773082|NCT04670263|Device|Tear Film Imager|Tear Film Imager recording
15773083|NCT04670250|Diagnostic Test|non invasive markers|non invasive markers (IL6, serum ferritin, fecal lactoferrin) used for monitoring of newly diagnosed patients with ulcerative colitis
15773084|NCT04670237|Device|Liberty677MTY Multifocal Toric IOL|multifocal, toric intraocular lens (IOL)
15773085|NCT04670224|Other|QLB anesthesia|The QLB is a bilateral locoregional anesthesia technique, performed after surgery, under general anesthesia and in right and then left lateral decubitus.
15773086|NCT04670224|Other|Intravenous anesthesia without QLB|only intravenous anesthesia
15773087|NCT04670211|Device|maxillary distractor|the type of maxillary distractor: tooth-borne, bone-borne or hybrid distractor
15773088|NCT04670198|Behavioral|Youth Empowerment Skills|The Youth Empowerment Skills (YES) programme is a novel psychoeducational intervention with simulation-based experiential learning tailored to the needs of young people. It is based on a social-cognitive learning model, and comprises attendance at 3 all-day YES sessions in non-healthcare settings (groups of 10); and then post-programme networking through social media and follow-up events facilitated by the youth worker. Sessions are led by a peer-educator and a health professional
15773089|NCT04670198|Behavioral|Waiting-list control|Usual care for 6 months, followed by the YES programme.
15773090|NCT04670185|Behavioral|BIP SAMBA|Behavioral parent management training
15773091|NCT04670159|Behavioral|Online Education|Online ergonomics, exercise and physical activity training will be provided 3 times a week for 6 weeks. The trainings it is planned to be made with a video-based online platform called Edpuzzle. With the online classroom created, the student education will be provided. A total of 18 training videos will be prepared, each video is 6-10 minutes. After the training there will be an individual motivational interview with the students in the this group with the zoom application. With motivational interview solutions by revealing the willingness, obstacles and indecision of the student to transfer the learned information to his daily life will be recommended.
15773092|NCT04670159|Behavioral|Information With Brochure|An e-brochure will be prepared for students in this group to provide information on ergonomics, physical activity and exercise. and the e-brochure will be sent to the students via e-mail after the initial evaluation.
15773093|NCT04670146|Diagnostic Test|ultrasound of the masseteric muscle|Ultrasound of the masseteric muscle to evaluate the thickness and rigidity of the masseteric muscle before and after oral cancer treatment. There will be no invasive investigation of the muscle.
15773094|NCT04670133|Dietary Supplement|Inulin|Supplementation with a prebiotic, specifically inulin.
15773095|NCT04670133|Dietary Supplement|Maltodextrin|Supplementation with maltodextrin (placebo)
15773096|NCT04670120|Drug|Pyrifazimine (TBI-166)|"The new drug pyrifazimine (previous name: TBI-166) is obtained by retaining the key skeleton of the lead drug clofazimine which can exert its efficacy and modification by introducing moderate polar groups structural. While the drug has strong activity against tuberculosis-sensitive bacteria and drug-resistant bacteria in vivo and in vitro, its pharmacokinetic properties and skin staining side effects have been significantly improved compared with the lead drugs, so that the drug can achieve the goal that reducing fat solubility, accelerating metabolism in the body, reducing skin staining and reducing side effects.
~In November 2016, the new anti-drug-resistant tuberculosis drug pyrifazimine and its tablets obtained the drug clinical approval issued by the CFDA, and were approved the clinical stage research that development of drug-resistant tuberculosis adaptation."
15773097|NCT04670107|Drug|Anlotinib in combination with Immune checkpoint inhibitors|Enrolled patients received anlotinib plus Pembrolizumab treatment (anlotinib, 8-12mg, qd, 2 weeks in a row and 1 week off; anti-PD1 injection or anti-PDL1 injection, Following instructions, iv.)
15773098|NCT04670081|Drug|Psilocybin|25 mg, p.o.
15773099|NCT04670081|Drug|Psilocybin|5 mg, p.o.
15773100|NCT04670081|Drug|Nicotinamide|100 mg, p.o.
15773101|NCT04670068|Drug|CAR.B7-H3|Two dose levels will be evaluated: Dose Level 1 (7.5x10^7 cells/infusion), dose Level 2 (2x10^8 cells/infusion). If dose limiting toxicities (DLTs) are observed per protocol, Dose Level -1 (3.75x10^6 cells/infusion) will be evaluated.
15773102|NCT04670068|Drug|Fludarabine|25 mg/m^2 IV for 3 consecutive days
15773103|NCT04670068|Drug|Cyclophosphamide|300 mg/m^2 IV for 3 consecutive days
15773104|NCT04670055|Drug|BCMA Targeted CAR T-cells|Each subject receive BCMA Targeted CAR T-cells by intravenous infusion
15773105|NCT04670042|Device|SPRINT® Peripheral Nerve Stimulation (PNS) System (510k Cleared)|Same as Arm Description.
15773106|NCT04670029|Other|Adapted physical activity|APA sessions during chemotherapy with aerobic and anaerobic sessions on site and at home (+ home exercises book if the patient so wishes)
15773107|NCT04670016|Other|This study does not include an intervention.|This study does not include an intervention.
15773108|NCT04670003|Other|users|Data of users of the web-application
15773109|NCT04669990|Drug|Remdesivir|The objective of this Registry study is to continue to collect safety and outcome data for COVID-19 patients who are treated with Remdesivir and convalescent plasma therapy (CPT).
15773110|NCT04669977|Dietary Supplement|Mulberry juice|One bottle (600ml/bottle) of sanitized mulberry juice would be sent to participants of the auxiliary group with instructions to consume 50ml of juice diluted with drinking water at room temperature. Also, a reminder of the next clinical visit is attached. They are expected to finish the mulberry juice in 10 to 11days instead of 12 days.
15773111|NCT04669964|Procedure|Intravenous Hydration|Patients will receive daily intravenous hydration of normal saline based on their ileostomy output.
15773112|NCT04669951|Other|uPAR immunohistochemistry|Resected esophageal cancer will be qualitatively and semi-quantitatively analyzed for uPAR expression
15773113|NCT04669938|Other|oropharyngeal and intestinal microbiota|analysis of oropharyngeal and intestinal microbiota
15773114|NCT04669938|Other|host genotype|analysis of a part of host genotype
15773115|NCT04669938|Other|host immune factors|analysis of host immune factors
15773116|NCT04669938|Other|viral sequence|analysis of viral sequence
15773119|NCT04669899|Drug|pimivalimab|Specified dose on specified days
15773120|NCT04669873|Radiation|Active Comparator: Standard|Radiation: Whole Breast Irradiation + Boost Whole breast, either 40Gy, in 15 fractions, in 3 weeks
15773121|NCT04669873|Radiation|Experimental 1: Hypofractionated radiotherapy|Radiation: Hypofractionated irradiation Whole Breast Irradiation 26Gy in 5 fractions in one week
15773122|NCT04669873|Radiation|Experimental 2: Accelerated Partial Breast Irradiation|Radiation: Accelerated partial breast irradiation Tumor bed 26Gy in 5 fractions, in 5 days.
15773123|NCT04669847|Other|Trunk-oriented exercise program|The trunk-oriented exercise program was performed by a physiotherapist two days of the week for 8 weeks.Trunk-oriented exercises were specially adapted to the patient based on the patient's functional status and active participation in the exercises.
15773124|NCT04669847|Other|Conventional exercise program|Conventional exercise program was performed daily for 8 weeks, twice a day, on average 45 minutes, each exercise 5-10 repetitions. The program formed stretching exercises, and active or active-assisted strength exercises (upper extremity, lower extremity, abdominal muscles, back muscles).
15773125|NCT04669834|Other|a traditional therapeutic knee rehabilitation program|mini-squatting exercise and clamshell exercise
15773126|NCT04669834|Other|core stability exercise|the principles of core stability will be explained to patients before initiation of treatment and patients will be asked to comply with these principles during exercise. These principles include learning how to activate transversus abdominus by abdominal bracing without allowing pelvis tilting and ensure neutral spine and diaphragmatic breathing during exercise.
15773127|NCT04669821|Drug|HSK3486|Loading Dose：0.1 mg/kg，Maintenance Dose：Maintenance is started at 0.3 mg/kg/h, and the dose can be adjusted up and down by 0.05-0.1 mg/kg/h.
15773128|NCT04669821|Drug|Propofol|Loading Dose：0.5 mg/kg，Maintenance Dose：Maintenance is started at1.5 mg/kg/h, and the dose can be adjusted up and down by 0.25-0.5mg/kg/h.
15773130|NCT04669795|Drug|Cissus Quadrangularis|Drug with osteogenic potential given to the patients after consolidation period. dose was two capsules once /day with meals for 6 weeks
15773131|NCT04669782|Dietary Supplement|Vitamin K (MK7)|MK-7 will be administered at a dose of 375 microg / day
15773132|NCT04669782|Drug|Teriparatide|Teriparatide will be administered as standard of care
15773133|NCT04669769|Other|interview|telephone interview
15773134|NCT04669756|Procedure|ovariopexy|if endometriosis was removed from the pelvic side wall or the ovary or both leading to an open wound adjacent to the ovary, ovariopexy was performed on both sides using a transabdominal-transovarian suture being tied extracorporeally on the patients Skin leading to uplifting of the ovary to the abdominal wall
15773135|NCT04669756|Procedure|placebo operation|in arm D sutures are transabdominal only
15773136|NCT04669743|Other|Ozone exposure|Exposures will take place at the UCSF Human Exposure Chamber Core Facility. Ozone will be added to the air in the chamber and concentration measured every 30 seconds. Subjects will exercise for two 15-minute intervals of each hour on a cycle ergometer, and will rest for two 15-minute intervals between exercise sessions. The rate of exercise will be individually adjusted to produce a targeted minute ventilation of 15-20 L/min/m2 body surface area. Subjects will be sent home post-exposure and will return to the laboratory on the following day and six days after the exposure for bronchoscopy.
15773137|NCT04669730|Other|usual care|Routine care
15773138|NCT04669730|Behavioral|Walk|Walk 30mins
15773139|NCT04669730|Behavioral|Baduanjin|Baduanjin exercise is moderate in intensity and short in duration (a set of Baduanjin takes about 12 minutes). Baduanjin consists of the sitting and standing practicing form. The sitting Baduanjin exercise conforms to the aspects of low-intensity and long-term aerobic activity, which is suitable for the rehabilitation training of patients who are in stable condition during hospitalization. The standing Baduanjin is more suitable for patients with sequential rehabilitation after discharge and can be adjusted based on the patient's condition
15773140|NCT04669730|Behavioral|Baduanjin plus walk|Walk 30mins then Baduanjin 12mins per day, 5 times per week.
15773141|NCT04669717|Drug|3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 7 days|Non-surgical periodontal therapy and radnomly administration of the antibiotics
15773142|NCT04669717|Drug|3/d 500 mg Amoxicilline Sandoz plus 500 mg Flagyl for 3 days|Non-surgical periodontal therapy and radnomly administration of the antibiotics
15773143|NCT04669717|Drug|1/d 500 mg Azithromycine Pfizer for 3 days|Non-surgical periodontal therapy and radnomly administration of the antibiotics
15773144|NCT04669704|Other|Experimental: Tablet application|"A protocol of exercises based on the current scientific evidence will be provided through a tablet application. A follow-up of the use of the application will be carried out. A minimum of 4-week home exercise intervention will be performed, which will have to be carried out daily by the patient autonomously at home for at least 5 days per week, starting after baseline measurement.
~The exercise program will be individualized according to each pathology."
15773145|NCT04669704|Other|Comparator: Conventional treatment|In the control condition, participants will receive a home exercise program on paper. The exercise program will be the conventionally prescribed one by the Andalusian Public Health Service. Participants will be told to perform exercises during a minimum of 4 week at home for at least 5 days per week, starting after baseline measurement.
15773147|NCT04669678|Drug|Etonogestrel (ETG) implant|Contraceptive progestin implants are thin rods inserted under the skin of a woman's arm. The most widely available implant in South Africa is currently Implanon®/Nexplanon®/Implanon NXT®, containing etonogestrel (ETG, 3-keto desogestrel). Implanon® consists of a single rod of ethylene vinyl acetate and contains 68 mg of ETG; it is manufactured by Merck and is approved for 3 years.
15773148|NCT04669678|Drug|Intramuscular depo-medroxyprogesterone acetate (IM DMPA)|DMPA (150 mg of depo-medroxyprogesterone acetate (MPA)/ml IMI) is the most commonly used injectable contraceptive worldwide, and the most commonly used method of reversible injectable contraception in sub-Saharan Africa.
15773149|NCT04669678|Drug|Sub-cutaneous medroxyprogesterone acetate (SC MPA)|SC MPA or Sayana® Press is a single-dose container with 104 mg medroxyprogesterone acetate (MPA) in 0.65 mL suspension for injection. Sayana® Press is indicated for medium-long term female contraception.
15773150|NCT04669678|Device|Non-hormonal intrauterine device (IUD)|The NOVA T-380 non-hormonal IUD consists of a T-shaped polyethylene frame wound with copper wire, along with two monofilament threads to aid in removal of the IUD. IUDs may be left in place for up to 5 years.
15773151|NCT04669665|Drug|SLS-002|Intranasal racemic ketamine hydrochloride 90 milligrams (mg)
15773152|NCT04669665|Drug|Placebo|Intranasal placebo
15773153|NCT04669665|Other|Standard of care|Standard of care treatment will be determined by the treating physician(s) based on clinical judgement and practice guidelines
15773154|NCT04669665|Device|Intranasal device|Device to deliver intranasal solution
15773155|NCT04669652|Device|Piezo-ICSI|During piezo-ICSI, a piezo-electric effect is generated through the conversion of electric energy to mechanical energy. This causes a smooth movement of the injection pipette, which allows for steady, controlled microinjection of a sperm with less psychical stress applied on the oocytes than by the conventional technique.
15773156|NCT04669639|Other|Block procedures for shoulder surgery analgesia|"The patients in group (a) will be placed in lateral decubitus. Then, an ultrasound-guided aseptic technique with a high-frequency linear transducer will be used to locate the transverse process of T2, where a needle will be inserted in a cephalocaudal direction until reaching the space between the fascia of the erector spinae and the transverse process of T2 and 30 ml of local anesthetic of bupivacaine 0.5% will be injected.
~In group (b), SSC nerve block will be done as follow: In the suprascapular notch, an ultrasound-guided aseptic technique with a high-frequency linear transducer will be used. The linear probe, enveloped in a sterile sheath, will be placed parallel to the spine of the scapula to visualize it and then will be moved cephalic to the supraspinatus fossa. The probe will then be moved laterally up to the scapular notch, where the nerve will be identified by its round hyperechogenic shape 4 cm deep.
~control group: patients will receive only general anesthesia"
15773157|NCT04669626|Other|Use of Ocetnilin|"Visits to the outpatient wound-care centre as directed by a physician. Wound care performed by the respective study nurse according to the study-protocol. Each dressing change will be the same and will be as follows:
~Removal of old dressing
~Applying a soaked gaze with Octenilin® on the wound (5 minutes)
~Mechanical debridement if necessary
~Wound cleansing with Octenilin®
~Application of new dressing (according to the wound healing phases, medical prescription)"
15773158|NCT04669626|Other|Use of NaCl 0.9%|"Visits to the outpatient wound-care centre as directed by a physician. Wound care performed by the respective study nurse according to the study-protocol. Each dressing change will be the same and will be as follows:
~Removal of old dressing
~Applying a soaked gaze with NaCl 0.9% solution on the wound (5 minutes)
~Mechanical debridement if necessary
~Wound cleansing with NaCl 0.9% solution
~Application of new dressing (according to the wound healing phases, medical prescription)"
15773159|NCT04669613|Other|CUDI|Analysis of the CEUS data by means of Contrast ultrasound dispersion imaging
15773160|NCT04669600|Drug|BIVV020|Pharmaceutical form:solution for injection
15773161|NCT04669587|Drug|ZB716|Pharmaceutical form: capsule Route of administration: oral
15773162|NCT04669587|Drug|Palbociclib|Pharmaceutical form: capsule Route of administration: oral
15773163|NCT04669561|Drug|Lifitegrast 5% Ophthalmic Solution|Open label, self-controlled, single group study of the efficacy of Lifitegrast 5% in improving higher order aberrations, ocular scatter index, and best corrected visual acuity in patients with dry eye. All patients will receive lifitegrast 5% for 4 weeks and will be evaluated at baseline (before treatment) and at 7, 14, and 28 days.
15773164|NCT04669548|Device|Accuryn Monitoring System|The Accuryn Monitoring System is a novel Foley catheter and monitoring device capable of detecting physiologic changes in vital signs via sensors within the catheter system. These data are captured non-invasively, continuously, and at a high frequency.
15773165|NCT04669535|Biological|AXO-AAV-GM2 Starting Dose|1:1 ratio of AAVrh8-HEXA and AAVrh8-HEXB, administered via bilateral thalamic (BiTh) and dual intracisterna magna (ICM)/intrathecal (IT) administration into the cerebrospinal fluid (CSF).
15773166|NCT04669535|Biological|AXO-AAV-GM2 Low Dose|1:1 ratio of AAVrh8-HEXA and AAVrh8-HEXB, administered via bilateral thalamic (BiTh) and dual intracisterna magna (ICM)/intrathecal (IT) administration into the cerebrospinal fluid (CSF).
15773167|NCT04669535|Biological|AXO-AAV-GM2 Middle Dose|1:1 ratio of AAVrh8-HEXA and AAVrh8-HEXB, administered via bilateral thalamic (BiTh) and dual intracisterna magna (ICM)/intrathecal (IT) administration into the cerebrospinal fluid (CSF).
15773168|NCT04669535|Biological|AXO-AAV-GM2 High Dose|1:1 ratio of AAVrh8-HEXA and AAVrh8-HEXB, administered via bilateral thalamic (BiTh) and dual intracisterna magna (ICM)/intrathecal (IT) administration into the cerebrospinal fluid (CSF).
15773169|NCT04669509|Diagnostic Test|Liver function tests|Patients' age, gender, comorbidity, Acute Physiology and Chronic Health Evaluation II (APACHE II), Sequential Organ Failure Assessment (SOFA) scores when first admitted to the ICU, hemogram parameters (white blood cell count, neutrophil, lymphocyte, hemoglobin, platelet count), coagulation parameters (prothrombin time, activated partial thromboplastin time and D-dimer, blood biochemistry results (C-reactive protein, lactate dehydrogenase, creatine kinase , alanine aminotransferase, aspartate aminotransferase, total bilirubin, direct bilirubin and indirect bilirubin), procalcitonin and ferritin levels will be recorded. In addition, the number of days spent in the ICU and whether mortality develops or not will be recorded. It will also be recorded whether mortality develops on day 7 and day 28.
15773170|NCT04669496|Drug|Neoadjuvant treatment|PD1 antibody (Toripalimab) combined with GEMOX chemotherapy and Lenvatinib neoadjuvant treatment
15773171|NCT04669483|Other|evidence-based informed consent form|Evidence-based informed consent forms for total knee arthroplasty and related anesthesia procedures will be developed. The design of the evidence-based informed consent forms will be guided by an existing guideline on how to present evidence-based health information (guideline evidence-based health information) and nocebo research. The information will be presented in plain language. Benefits and harms of the procedures will be presented in absolute risk formats and in comparison with other interventions or placebo. Verbal presentations of risks lead to overestimations of risks and therefore, will not be applied exclusively. Gain and loss framing will be combined. To visualize important aspects, pictograms will be used. Information on uncertainty, missing or low quality evidence will be provided.
15773172|NCT04669470|Procedure|bariatric endoscopy, mainly intragastric baloons, plication of stomach too|bariatric endoscopy, mainly intragastric baloons, plication of stomach too
15773231|NCT04669041|Drug|Placebo|Pharmaceutical form:Tablet Route of administration: Oral
15773232|NCT04669041|Drug|Placebo|Pharmaceutical form:Capsule Route of administration: Oral
15773173|NCT04669457|Drug|Intra-nasal Dexmedetomidine|Subjects will receive Dexmedetomidine intra-nasally in the preoperative area. It will be administered at a dose of 1 mcg/kg, approximately 15-25 minutes before entering the operating room.
15773174|NCT04669457|Drug|Oral Midazolam|Subjects will receive Midazolam orally in the preoperative area. It will be administered at a dose of 0.5 mg/kg (with a maximum dose of 20 mg), approximately 10-15 minutes before entering the operating room.
15773175|NCT04669444|Device|Ventilator|The patient starts at a ventilator driving pressure of 10-15 cm of H2O as per guidelines for patients on ECMO with ARDS. The driving pressure is then decreased as tolerated for two hours to evaluate the effects on pulmonary, cardiac, and inflammatory biomarkers.
15773176|NCT04669431|Other|Xbox kinect Training|Xbox kinect 360, Tennis player, Joy riding, Rally ball. Tennis player in first 2 weeks, Joy riding in 3rd and 4th weeks, and all 3 games in 5th and 6th weeks 35 minute/3 days a week for 6 weeks with Conventional physical therapy, 25 minute
15773177|NCT04669431|Other|Conservative Rehabilitation|Sustained Stretching, repetitive task training, activities of daily living( eating, grooming, folding of towel, basket lifting, turn key into lock, reaching forward, sideways reach, ball grasping, picking up small blocks and lifting cane and pencil) 35 minute/3 days a week for 6 weeks
15773178|NCT04669418|Diagnostic Test|RNA expression signature|Whole transcriptome profiling using RNA sequencing
15773179|NCT04669405|Device|High intensity laser therapy|A prospective, randomized, controlled study was undertaken. A total of 44 patients who met inclusion criteria were randomly divided into two groups. HILT group (n=22) received 3 sessions of HILT per week for 3 weeks in addition to the multidisciplinary stroke rehabilitation and exercise program which performed 5 sessions per week for 3 weeks. Control group (n=22) received a multidisciplinary stroke rehabilitation and exercise program for HSP of 5 sessions per week for 3 weeks.
15773180|NCT04669405|Other|Therapeutic Exercise|A prospective, randomized, controlled study was undertaken. A total of 44 patients who met inclusion criteria were randomly divided into two groups. HILT group (n=22) received 3 sessions of HILT per week for 3 weeks in addition to the multidisciplinary stroke rehabilitation and exercise program which performed 5 sessions per week for 3 weeks. Control group (n=22) received a multidisciplinary stroke rehabilitation and exercise program for HSP of 5 sessions per week for 3 weeks.
15773181|NCT04669392|Drug|70% Ethanol Alcohol|"Ethanol, also called ethyl alcohol, grain alcohol, or alcohol, a member of a class of organic compounds that are given the general name alcohols.
~Ethanol is a commonly used fixative. Fixation of the inner layers of the tissue depends on the ability of the fixative to diffuse into the tissue. Moreover, Ethanol has antibacterial antifungal, and antiviral properties.
~70% Ethanol is the safest concentration because the water that has been mixed into the ethanol slows the drying time, creating a longer contact time. Ethanol needs to have a contact time of at least 10 seconds to kill Staphylococcus aureus and Streptococcus pyogenes. At a 10 second drying time."
15773182|NCT04669379|Behavioral|EXPECT: Preoperative optimization of patient's expectations|Patients work through an online-tool (around 30 minutes). This preoperative intervention aims to optimize patients' expectations by focusing on positive and realistic expectations regarding the surgery-benefits and recovery process, giving information, and giving advice for coping resources.
15773183|NCT04669366|Drug|sunitinib|As provided in real world
15773184|NCT04669366|Drug|axitinib|As provided in real world
15773185|NCT04669353|Drug|Platelet rich plasma|approximately 15 cm of whole blood was drawn from the uninvolved arm of each patient in the intervention group (group I) into a 20 ml sterile syringe containing citrate for anticoagulation. The blood was immediately centrifuged at 3200 Revolutions per Minute (PRM). Following 15 minutes of centrifugation, 4 - 5 mL of PRP was obtained. Then, the PRP was buffered by using sodium bicarbonate.
15773186|NCT04669340|Other|E-learning patient education|"The intervention implies patient education through an e-learning program. The program consists of three learning modules covering knowledge of rheumatoid arthritis, medication, examinations, complications and daily living with RA. Module 1 consists of 'need to know' information about disease management, symptoms and medication. Thus, it is mandatory and must be completed before entering module 2 and 3. In module 2 and 3, patients can move around on the basis of their individual needs.
~The duration of the full program is approximately two hours, but may vary dependent on the individual user needs. The program may be used as much as needed throughout the study period."
15773187|NCT04669340|Other|Standard face-to-face patient education|The intervention implies usual care, i.e. face-to-face patient education in a one-hour session with a nurse at the hospital. This form of patient education is based on the patients individual need for information and guidance in relation to rheumatoid arthritis and medication. Thus, aspects of daily life with the disease is discussed at the beginning and forms the conversation. However, as a standard, information of the disease, disease management, symptoms and medication must be discussed with the patient and relatives.
15773188|NCT04669327|Other|gait analysis|Vicon nexus with MTI force plate form
15773189|NCT04669314|Procedure|Liver resection or enucleation for liver hemangioma|Operations in which the hemangioma is selectively removed from the liver parenchyma border are named enucleation, and the operations in which the hemangioma is removed anatomically or non-anatomically with some liver parenchyma surrounding it are named liver resection
15773190|NCT04669301|Behavioral|MAAT-G|Memory and Attention Adaptation Training (MAAT) is a cognitive-behavioral therapy (CBT)-based intervention for CRCD. As a CBT-based intervention, MAAT focuses on an individual's psychological response to injury as compared to the biological events triggering CRCD. MAAT is a series of manualized workshops delivered by a psychologist via video-conferencing, supplemented by a participant workbook, which provide instruction and practice with adaptive behavioral coping skills, stress management techniques, and compensation strategies.
15773191|NCT04669301|Behavioral|Supportive therapy (time and attention control)|"Supportive Therapy (ST) is a behavioral placebo and controls for non-specific psychotherapeutic factors of the clinician-subject relationship, such as empathy and support, but does not provide active cognitive training. ST utilizes reflective listening to help deepen awareness of participants' emotional experience. Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 45 minutes each, delivered by trained psychologists via video-conferencing."
15773192|NCT04669288|Drug|Azithromycin|"oral azithromycin (12 mg/kg per day for 5 days)
~Local investigational drug pharmacies will be provided with active study medication (azithromycin) from a central pharmacy. Azithromycin will be reconstituted with water at the local pharmacy, and will resemble placebo with regards to appearance, flavor, consistency and packaging."
15773193|NCT04669288|Drug|Placebo|"oral placebo (12 mg/kg per day for 5 days)
~Local investigational drug pharmacies will be provided with placebo from a central pharmacy. Placebo will be reconstituted with water at the local pharmacy, and will resemble azithromycin with regards to appearance, flavor, consistency and packaging."
15773194|NCT04669275|Behavioral|Telephone Counselıng|Telephone counseling
15773195|NCT04669262|Drug|BGB-DXP604|Administered as intravenous (IV) infusion over 30 to 60 minutes
15773196|NCT04669262|Drug|BGB-DXP593|Administered as intravenous (IV) infusion over 30 to 60 minutes
15773197|NCT04669262|Drug|Placebo|Placebo to match BGB-DXP593
15773198|NCT04669262|Drug|Placebo|Placebo to match BGB-DXP604
15773199|NCT04669249|Behavioral|PROCare|PROCare is a reward-based digital recovery management platform for individuals receiving medication treatment for opioid use disorder. Patients have the opportunity to earn both non-monetary and monetary incentives via smart debit card for a variety of clinically-indicated behaviors, including taking their medication (buprenorphine) as directed, attending clinic appointments and community-based mutual-help support group meetings, participating in routine outcomes monitoring surveys using validated measures, accessing the curated psychoeducation content library, and engaging in other recovery-oriented activities within the smartphone app.
15773200|NCT04669236|Behavioral|Intervention to promote healthy sleep behavior|An action group (6 - 8 pupils) was conducted at each school. Brainstorm sessions about effective strategies to change sleeping behavior in this population were held. Strategies, perceived as effective by the target population, will be summarized in an overview. Also feedback of adolescent, who are not part of the action group, will be asked. After feedback, the intervention will be developed by the intervention schools. Thereby, three different intervention strategies will be implemented and tested (one intervention at each school) to meet the individuals needs of each school. The action groups will develop the intervention materials during sessions this year. Afterwards, they will implement the intervention themselves in collaboration with teachers of the school and the researchers.
15773201|NCT04669223|Device|Seldinger chest drain insertion|Different sizes of chest drain will be inserted with seldinger technique
15773202|NCT04669210|Drug|Ruxolitinib|Ruxolitinib administered during conditioning 5 mg tid before allogeneic hematopoietic stem cell transplantation, 5 mg tid days 5-21 and 5 mg bid days 22-150 after transplantation instead of tacrolimus and MMF.
15773203|NCT04669210|Drug|Tacrolimus|Tacrolimus 0.03 mg/kg adjusted to concentrations 5-15 ng/ml from day+5 to +100
15773204|NCT04669210|Drug|Mycophenolate Mofetil|Mycophenolate mofetil 30 mg/kg from day +5 to +35
15773205|NCT04669197|Drug|Paclitaxel protein bound|combination therapy
15773206|NCT04669197|Drug|Gemcitabine|combination therapy
15773207|NCT04669197|Drug|Cisplatin|combination therapy
15773208|NCT04669197|Drug|Hydroxychloroquine|combination therapy
15773209|NCT04669171|Biological|EO2463|Multiple dose of EO2463
15773210|NCT04669171|Drug|lenalidomide|D1-21 of 4-weekly cycles
15773211|NCT04669171|Biological|rituximab|Multiple doses of rituximab
15773212|NCT04669158|Drug|Idebenone|Idebenone, initially 200mg by mouth (P.O.) once a day for 2 weeks, then 200 mg twice a day for 2 weeks, then 200 mg three times per day for the remainder of the study will be used.
15773213|NCT04669158|Drug|Placebo|Placebo to match Idebenone once a day for 2 weeks, then twice a day for 2 weeks, then three times per day for the remainder of the study will be used.
15773214|NCT04669145|Drug|Ropivacaine|Dosing and volume will vary based on type of block used and weight of patient because of the pediatric population in the study.
15773215|NCT04669132|Drug|Olanzapine|- Olanzapine 5mg, administered once daily, during 5 days (day before chemotherapy, the D day of the chemotherapy and 3 day after chemotherapy)
15773216|NCT04669132|Drug|Netupitant|- Netupitanto 300 mg, once daily, on chemotherapy day;
15773217|NCT04669132|Drug|Palonesetron|- Palonosetron 0.56 mg, once daily, on chemotherapy day;
15773218|NCT04669119|Dietary Supplement|Bromelain/Boswellia Serrata Casperome|Dietary supplement already commercialized based on Bromelain/Boswellia Serrata Casperome (Arm A and B), called Siben by Agaton
15773219|NCT04669119|Dietary Supplement|Centella Asiatica/Vitamins|Dietary supplement already commercialized based on Centella Asiatica/Vitamins (Arm B), called Kardinal V by Agaton
15773220|NCT04669119|Dietary Supplement|Placebo|Placebo
15773221|NCT04669106|Other|laboratory clinical trial study|The research stage consisted of two stages, the first stage was the initial screening of the primary data of the research subjects, namely by analyzing food intake including mineral intake data, the diet of the research subjects, mineral and enzyme levels, and data on soil conditions in the area. The second stage was to analyze the relationship between the existing variables so that the most significant relationship was seen between the differences in diet, mineral content, enzyme levels, and soil content between the two groups.
15773222|NCT04669093|Behavioral|"Placebo cream- promotion suggestion"|"Over-the-counter hand cream will be applied to participants' skin, but they will be told that they are given a highly efficient topical analgesic cream. The suggestion will be based on a promotion approach (promoting good feelings)."
15773223|NCT04669093|Behavioral|"Placebo cream- prevention suggestion"|"Over-the-counter hand cream will be applied to participants' skin, but they will be told that they are given a highly efficient topical analgesic cream. The suggestion will be based on a prevention approach (preventing pain)."
15773224|NCT04669093|Behavioral|Control cream|In a control condition, with the same cream as in the placebo interventions, participants will be instructed that the cream is a control cream with no effects.
15773225|NCT04669080|Behavioral|Health care provider cost navigation training|Health care providers and asthma educators in a pediatric asthma clinic will receive an online training about the importance of cost of care conversations, how to start cost of care conversations with families, how to refer families to cost navigation resources, and how to lead asthma specialty care teams in cost navigation.
15773226|NCT04669067|Drug|TL-895|TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
15773227|NCT04669067|Drug|KRT-232|KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth.
15773228|NCT04669041|Drug|Rosuvastatin|Pharmaceutical form:Tablet Route of administration: Oral
15773229|NCT04669041|Drug|SPC ezetimibe/rosuvastatin|Pharmaceutical form:Tablet Route of administration: Oral
15773230|NCT04669041|Drug|Rosuvastatin active capsule|Pharmaceutical form:Capsule Route of administration: Oral
15773233|NCT04669028|Drug|NE3107|NE3107 is an investigational orally bioavailable, blood-brain barrier permeable anti-inflammatory agent with a new mechanism of action targeting multiple mechanisms of pathology in Alzheimer's disease.
15773234|NCT04669028|Drug|Placebo|capsules that do not contain NE3107
15773235|NCT04669015|Biological|Novaferon|a novel recombinant antiviral protein drug
15773236|NCT04669015|Biological|Placebo|Formulation vehicle
15773237|NCT04669002|Drug|EP0057|EP0057 is an investigational nanoparticle-drug conjugate with a Camptothecin payload, that is administered intravenously
15773238|NCT04669002|Drug|Olaparib tablets|Olaparib is a PARP inhibitor (poly [adenosine diphosphate-ribose] polymerase inhibitor)
15773239|NCT04668989|Device|stenfilcon A - (Test lens)|Subjects will be randomized to wear test lenses for one week.
15773240|NCT04668989|Device|kalifilcon A - (Control Lens)|Subjects will be randomized to wear control lenses for one week.
15773241|NCT04668976|Device|Medtronic pump and Codman catheter|All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
15773242|NCT04668976|Drug|Floxuridine (FUDR)|Please see Detailed Description.
15773243|NCT04668976|Drug|Gemcitabine|Please see Detailed Description.
15773244|NCT04668976|Drug|Oxaliplatin|Please see Detailed Description.
15773245|NCT04668976|Drug|Irinotecan (CPT-11)|Please see Detailed Description.
15773246|NCT04668976|Drug|Fluorouracil|Please see Detailed Description.
15773247|NCT04668976|Drug|Anti-EGFR (Panitumumab or Cetuximab)|Please see Detailed Description.
15773248|NCT04668963|Device|MIRROR THERAPY|patients were seated on a chair, with the mirror positioned between the upper limbs perpendicular to the subject's midline and with the unaffected upper limb facing the reflective surface. Following the physiotherapist indications, the patients observed the reflection of their unaffected limb while performing the following movements with the both arms, the affected one as good as possible: flexion and extension of the shoulder, elbow, wrist and finger, prone supination of the forearm.
15773249|NCT04668950|Drug|Fluvoxamine|Up to 200mg per day (2 capsules per day) as tolerated, for approximately 15 days
15773250|NCT04668950|Drug|Placebo|Will take 2 capsules per day as tolerated for approximately 15 days
15773251|NCT04668924|Procedure|Epi-on PiXL in high oxygen|After local anaesthetics, the keratoconus cornea is soaked in Riboflavin by repeated topical application during 10 minutes. A Riboflavin soaked sponge is used to lightly disrupt the epithelium tight junctions, without epithelium debridement. The cornea is illuminated with PiXL under 16:40 minutes during continuously delivery of humidified high oxygen via specific oxygen googles. The UV-dosage is individually customized based upon Kmax; for < 45 Diopters (D) 7.2J/cm^2 will be used; for 45-50D 10J/cm^2 will be used; for > 50D 15 J/cm^2 will be used.
15773252|NCT04668911|Other|Swab|PCR test for SARS-CoV2, oral and nasal swab
15773253|NCT04668885|Drug|CPX-351|"Induction phase: CPX-351 15 mg/m^2 on days 1 and 3 of each 28-day cycle for up to a total of 6 cycles in the absence of unacceptable toxicity
~Maintenance phase: CPX-351 7.5 mg/m^2 on days 1 and 3 for two cycles alternating with 15 mg/m^2 for one cycle. Participants may receive up to 12 cycles of maintenance phase in the absence of unacceptable toxicity."
15773254|NCT04668872|Radiation|Y90 TARE|Y90 TARE will be performed as standard of care (SOC)/clinically indicated: 1) in a lobar or sub-lobar fashion (depending on tumor involvement and location; also targeting the tumor as selective as possible and sparing as much as possible of non-involved liver parenchyma), for participants with extensive bilobar disease or 2) in a radiation segmentectomy approach, intending to deliver 190 Gy radiation dose to target tumor: for patients with limited liver metastatic disease, not amenable for surgery or ablation.
15773255|NCT04668872|Diagnostic Test|PET/CT|Following 90Y TARE, participants will receive a PET/CT or PET/MRI scan to measure the dose administered to the target tumor(s) and uninvolved hepatic parenchyma.
15773256|NCT04668872|Diagnostic Test|PET/MRI|Following 90Y TARE, participants will receive a PET/CT or PET/MRI scan to measure the dose administered to the target tumor(s) and uninvolved hepatic parenchyma.
15773257|NCT04668859|Drug|Midodrine|oral vasoactive that is metabolized by the liver an peripheral tissues into desglymidodrine, an active metabolite. It produces arteriolar and venous constriction with a subsequent elevation in blood pressure.
15773258|NCT04668859|Drug|Methylcellulose|Placebo will consist of inert methylcellulose
15773259|NCT04668846|Other|non-invasive sample collection of skin tissue|Both lesional and non-lesional skin will be sampled with up to 24 adhesive patches.
15773260|NCT04668833|Procedure|Autologous lymphocyte infusion (ALI)|On the day after completing the last dose of radiation therapy, the patient will have an appointment scheduled in the Apheresis Unit for the infusion of unmunipulated cryopreserved cells. Patients will be pre medicated with acetaminophen (325-650 mg PO) and diphenhydramine (12.5-25 mg PO or IV) prior to infusion. Cells will be infused without a leukoreduction filter at a rate determined by cell volume.
15773261|NCT04668820|Diagnostic Test|video Pediatric Gait, Arms, Legs and Spine (V-pGALS)|The Video-pGALS includes maneuvers from pediatric regional examination of the musculoskeletal system (pREMS) and derived from the pediatric gait arms legs spine examination assessment which is a validated simple basic musculoskeletal (MSK) examination for children. V-pGALS offers a structured approach to a cursory overview MSK exam with a focus on range of movement and symmetry. Utilizing the parent or caregiver to feel the joint in question for obvious warmth/ swelling or to palpate for point of maximal tenderness can add important information.
15773262|NCT04668807|Device|Connected Medical Device|Monitoring of three simple physiological parameters (SpO2, heart rate and respiratory rate) with a Connected Medical Device (DMC) in the operating room
15773263|NCT04668807|Device|Traditional transmission system|Monitoring of physiological parameters with a traditional wired transmission system between the sensor and the data processing device in the operating room
15773264|NCT04668794|Procedure|Osteosynthesis|Reduction and fixation of the carpometacarpal fracture dislocation of the hand with osteosynthesis (Kirschners wires, plate and screws)
15773265|NCT04668781|Procedure|Analgesia via epidural catheter|Ropivacain-infusion 2 mg/ml 1,25ml/h/10kg IBW (ideal body weight) is started to patients in the beginning of the surgery and is continued to POD 4. The rest of the treatment obey study protocol in both groups.
15773298|NCT04668456|Drug|Dexmedetomidine|the drug administered either subtenon ot iv
15773299|NCT04668456|Drug|lidocaine 2%|subtenon injection
15773300|NCT04668456|Drug|bupivacine 0.5%|subtenon injection
15773266|NCT04668781|Procedure|Analgesia via wound catheter|Ropivacain 5 mg/ml 2,5ml/10kg IBW (ideal body weight) is given to patients in the end of the surgery. After that ropivacain-infusion 2mg/ml 1,25ml/h/10kg IBW is started to patients and is continued to POD 4. The rest of the treatment obey study protocol in both groups.
15773267|NCT04668768|Drug|Glucarpidase|Glucarpidase injection to prevent toxicities due to high dose methotrexate treatment
15773268|NCT04668755|Device|Charcot Restraint Orthotic Walker 3d printed sole|"The Charcot Restraint Orthotic Walker (CROW) consists of anterior and posterior shells creating a total contact environment based on a rocker sole. the sole is manufactured by 3d printed Metamaterial .
~Manufacture of the 3d printed sole of the CROW paths through two stages ;Computer aided designing (CAD) and computer aided manufacturing (CAM) ."
15773269|NCT04668755|Device|Generic Charcot Restraint orthotic walker|It is a clamshell (two piece) design that provides complete/total contact over the shin, calf and foot. The CROW reduces all motion in the ankle and foot to reduce potential for further injury. It is fully padded on the inside, and the bottom is covered with a material similar to shoe soling. It is not worn with a shoe.
15773270|NCT04668742|Device|DYNAtraq|Tracheostomy alignment with DYNAtraq
15773271|NCT04668729|Other|Chiropractic Manipulation|"Lumbar vertebrae and sacroiliac joints of the participants that have lost their normal joint motion will be detected by static and dynamic palpation techniques.
~Lumbal Chiropractic HVLA Spinal Manipulation: HVLA manipulation will be applied in the left transverse process of the lumbar vertebra (mammillary process) of the participants whose problem is to the left of the lumbar vertebra.
~Sacroiliac Chiropractic HVLA Manipulation: Participants who lost normal joint motion in the anterior and superior directions in the left sacroiliac joint will be treated with HVLA manipulation in the left PSIS (Posterior Superior Iliac Spine: PSIS). Participants who have lost normal joint motion in the left sacroiliac joint in the posterior and inferior directions will be applied HVLA manipulation in the left ischial tuberosity.
~For both applications, it will be positioned in the opposite position for the problems on the right and the application will be made in the opposite position."
15773272|NCT04668703|Procedure|Conbercept intravitreal injection|intravitreal injection of 0.5 mg conbercept at the conclusion of cataract surgery
15773273|NCT04668690|Drug|Mitoxantrone Hydrochloride Liposome Injection|Drug: Liposomal mitoxantrone hydrochloride (20 mg/m2) administered as an intravenous infusion on day 1 of each 28-day cycle.
15773274|NCT04668690|Drug|Chidamide|Drug: Chidamide tablet (30 mg) is given to the patients p.o. 30 minutes after breakfast, twice per week with 3-day intervals.
15773275|NCT04668677|Other|On-line questionnaire|On-line questionnaire about working life, medical care, functional recovery, quality of life and psychological state.
15773277|NCT04668651|Other|antral ultrasound|Preoperative evaluation of gastric contents by antral ultrasound
15773278|NCT04668638|Other|Respiratory rehabilitation|Respiratory rehabilitation includes education, hypoventilation exercises, diaphragmatic breathing exercises, relaxation, retraining, others.
15773279|NCT04668625|Behavioral|Participate in a massive musical event|Participate in a massive musical event
15773280|NCT04668612|Device|Dual-bolus|Dual-bolus (50/50% with second part over 2 hours) for all meals after 6:00 p.m.
15773281|NCT04668612|Device|Standard bolus|Standard boluses for all meals
15773282|NCT04668599|Other|Cardiopulmonary rehabilitation|Patients will undergo standardized cardio-pulmonary rehabilitation program.
15773283|NCT04668586|Device|Holmium:YAG laser machine|Ureteroscopy with Holmium:YAG laser lithotripsy
15773284|NCT04668586|Device|Thulium Fiber laser machine|Ureteroscopy with Thulium Fiber laser lithotripsy
15773285|NCT04668573|Other|Trunk exercise|Trunk exercise includes trunk muscles stretching, trunk muscles strengthening, and task-related trunk control training for 30 minutes per session, twice a week for 12 weeks.
15773286|NCT04668560|Behavioral|Five ways to wellbeing course|A behavioural course over six sessions. Teaching the participants in doing avtivities to promote wellbeing
15773287|NCT04668547|Device|Hysteroscopic Embryolysis|Hysteroscopic removal of the products of conception for induced abortion using a hysteroscopic morcellator. If this method of induced abortion fails, a traditional Dilation and Curettage procedure is performed
15773288|NCT04668534|Device|taVNS 10|"Patients were given taVNS (by Xi'an Bashui Health Technology Co., Ltd) thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s on periods and 30s off periods; frequency: 10 Hz; current intensity: minimal pain threshold; pulse width: 500 μs)"
15773289|NCT04668534|Device|taVNS 25|"Patients were given taVNS (by Xi'an Bashui Health Technology Co., Ltd) thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s on periods and 30s off periods; frequency: 25 Hz; current intensity: minimal pain threshold; pulse width: 500 μs)"
15773290|NCT04668534|Device|Control|"Patients were given taVNS (by Xi'an Bashui Health Technology Co., Ltd) thirty minutes twice a day in the morning and the night for four weeks (duty circle: 30s on periods and 30s off periods; frequency: 10 Hz; current intensity: minimal pain threshold; pulse width: 500 μs)"
15773291|NCT04668521|Other|OVA360|Multifactorial Risk Assessment for Breast & Ovarian Cancer Risk Detection
15773292|NCT04668508|Drug|Anlotinib|concurrent using anlotinib combined with radiation plus adjuvant anlotinib after radiotherapy until disease progress or develop into serious adverse events.
15773293|NCT04668482|Device|SCS is switched off|Spinal cord stimulator is switched off for 12 hours
15773294|NCT04668482|Device|SCS is switched on|Spinal cord stimulator is functioning
15773295|NCT04668469|Drug|Ivermectin|"evaluation of the anti-parasitic medication efficacy Ivermectin (Ivermectin 400 mcg/kg body weight maximum 4 tablets (6mg / tablet) once daily dose before breakfast) plus standard care in the treatment of mild/moderate cases with COVID 19 infection"
15773296|NCT04668469|Drug|Hydroxychloroquine|evaluation of hydroxychlorquine (400 every 12 hours for one day followed by 200 mg every 12 hours for 5 days) plus standard care in the treatment of mild/moderate cases with COVID 19 infection
15773297|NCT04668469|Behavioral|personal protective Measures|evaluation of personal protective Measures (hand hygiene, social distancing measures, avoiding touching the eyes, nose and mouth, wearing masks, and self-isolation) only as a prophylaxis for health care and or household contacts' from COVID-19 disease
15773302|NCT04668443|Other|Graphical Informed Consent (GIC)|The GIC (set of illustrations that complement the written information and consent form) will be proposed to prospective participants by researchers, systematically during the pre-test (stage 1). If the stage 1 shows no negative impact of the GIC on the consent process, the stage 2 will be implemented and the GIC will be proposed by researchers when they feel it could be beneficial for the participant.
15773303|NCT04668430|Other|imaging and motion analysis|performing a set of imaging and motion analysis tests before and after orthopedic surgery without modifying the operative indication or the pre- and post-operative management.
15773304|NCT04668417|Behavioral|Portal Reminders for Second Dose of Influenza Vaccine with Direct Scheduling Link|Patient proxy receives reminder/recall messages via the patient portal to get a second dose of influenza vaccine with a direct scheduling link included, enabling the patient to directly schedule a flu vaccination only visit
15773305|NCT04668417|Behavioral|Portal Reminders for Second Dose of Influenza Vaccine without Direct Scheduling Link|Patient proxy receives reminder/recall messages via the patient portal to get a second dose of influenza vaccine with no direct scheduling link included
15773306|NCT04668404|Diagnostic Test|Sonoclot|Sonoclot machine
15773309|NCT04668378|Other|Time restricted eating|TRE subjects consumed 100 % of their energy needs divided into three meals consumed at 1 p.m., 4 p.m. and 8 p.m., and fasted for the remaining 16 h per 24-h period.
15773310|NCT04668378|Other|Normal Diet|ND group ingested their caloric intake as three meals consumed at 8 a.m., 1 p.m. and 8 p.m.
15773311|NCT04668365|Drug|Rituximab|375mg/m2, Intravenous administration on day 0 of each 3-week cycle.
15773312|NCT04668365|Drug|Zanubrutinib|160mg twice daily continuous oral administration.
15773313|NCT04668365|Drug|Cyclophosphamide|750mg/m2, Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease after 2 cycles treatment, disease progression after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.
15773314|NCT04668365|Drug|Epirubicin|70mg/m2, Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease after 2 cycles treatment, disease progression after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.
15773315|NCT04668365|Drug|Vincristine|1.4mg/m2 (Max: 2mg), Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease after 2 cycles treatment, disease progression after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.
15773316|NCT04668365|Drug|Prednisone|100mg, oral administration on day 1 to 5 of each 3-week cycle until disease progression/stable disease after 2 cycles treatment, disease progression after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.
15773317|NCT04668352|Drug|Dactolisib|TORC1 inhibitor
15773318|NCT04668352|Other|Placebo|Placebo
15773319|NCT04668339|Biological|ARCT-021 single dose priming|ARCT-021 higher dose (one dose) + placebo (one dose)
15773320|NCT04668339|Biological|ARCT-021 two lower dose priming|ARCT-021 lower dose (two doses, Day 0 and Day 28)
15773321|NCT04668339|Biological|ARCT-021 two higher dose priming|ARCT-021 higher dose (two doses, Day 0 and Day 28)
15773322|NCT04668339|Biological|Placebo (two doses), priming|Placebo (two doses, Day 0 and Day 28)
15773323|NCT04668339|Biological|Randomized booster|ARCT-021 (single dose) OR placebo, booster
15773324|NCT04668339|Biological|Placebo booster|Placebo (single dose)
15773325|NCT04668326|Device|Manual Standing Wheelchair|Mobile in seated position; Not mobile in standing position
15773326|NCT04668326|Device|Mobile Manual Standing Wheelchair|Mobile in BOTH seated and standing positions
15773327|NCT04668300|Biological|Durvalumab|Given IV
15773328|NCT04668300|Biological|Oleclumab|Given IV
15773329|NCT04668287|Behavioral|Increasing self-esteem|During 5 weeks, participants will be part of one of the working groups in which they'll be taught by a counselor about how a low self-esteem develops and what have to be done for improving self-esteem, based on the Melanie Fennel' model.
15773330|NCT04668274|Drug|200 mg resveratrol as JOTROL|Low (first) dose of single ascending dose study
15773331|NCT04668274|Drug|500 mg resveratrol as JOTROL|Second (intermediate) dose of single ascending dose study
15773332|NCT04668274|Drug|1000 mg resveratrol as JOTROL|Third (highest) dose of single ascending dose study
15773333|NCT04668274|Drug|1000 mg resveratrol as JOTROL administered to assess influence of food|1000 mg resveratrol as JOTROL administered to assess influence of food
15773334|NCT04668261|Other|Advanced imaging investigation|MRI imaging
15773365|NCT04668053|Other|Traditional training protocol|Mobility and core strengthening and the steps and lunges As per athletes requirement Body weight squat with 12 reps, Body weight split squat with 8 each side, Bilateral hip raise with 12 reps, Push-up with15 reps and Cricket related skills as per coach advised
15773427|NCT04667520|Behavioral|Lifestyle Physical Activity (LPA)|This intervention has 3 components: (1) an orientation session to LPA and using the Fitbit; (2) Six telephone physical activity counseling sessions; and (3) monitoring activity with the Fitbit, which is provided to them during their study participation.
15840081|NCT04123405|Drug|acetylcysteine|600 mg tablet
15773337|NCT04668235|Drug|AZVUDINE|5 tablets QD + standard treatment for up to 14 days
15773338|NCT04668235|Drug|AZVUDINE placebo|5 tablets QD + standard treatment for up to 14 days
15773339|NCT04668222|Drug|Yu-Ping-Feng formula|Yu-Ping-Feng formula produced by PuraPharm International (H.K) Ltd is a registered Chinese medicine formula by Chinese Medicine Council of Hong Kong (registration number: HKC-08255). The intake dosage is 5g twice daily.
15773340|NCT04668222|Drug|Xiang-Sha-Liu-Jun formula|Xiang-Sha-Liu-Jun formula produced by PuraPharm International (H.K) Ltd is a registered Chinese medicine formula by Chinese Medicine Council of Hong Kong (registration number: HKC-08252). The intake dosage is 5g twice daily.
15773341|NCT04668222|Drug|Liu-Wei-Di-Huang formula|Liu-Wei-Di-Huang formula produced by PuraPharm International (H.K) Ltd is a registered Chinese medicine formula by Chinese Medicine Council of Hong Kong (registration number: HKC-08273). The intake dosage is 5g twice daily.
15773342|NCT04668222|Drug|"Placebo for Deficiency of Qi and Yang"|"Placebo for the group of deficiency of Qi and Yang is composed of 5% Yu-Ping-Feng formula+Xiang-Sha-Liu-Jun formula"
15773343|NCT04668222|Drug|"Placebo for Deficiency of Qi and Yin"|"Placebo for the group of deficiency of Qi and Yin is composed of 5% Yu-Ping-Feng formula+Liu-Wei-Di-Huang formula"
15773344|NCT04668209|Drug|Silmitasertib|Standard of care / best supportive care in combination with CX-4945 1000 mg administered orally, two times a day.
15773345|NCT04668196|Device|High-flow nasal cannula treatment|Standard operating procedures represented by hihg-flow nasal cannula oxygen therapy
15773346|NCT04668196|Device|Continuous positive airway pressure (CPAP) treatment|Standard operating procedures represented by continuous positive airway pressure (CPAP) therapy
15773347|NCT04668196|Device|Noninvasive ventilation treatment|Standard operating procedures represented by noninvasive ventilation treatment
15773348|NCT04668183|Procedure|Pudendal nerve block group|A 22 Gauge 50 mm insulated needle was then introduced in the anterior-posterior direction at the middle of the ultrasound probe's superior edge with an out-of-plane approach and using an inclination of 15° in the sagittal plane. The needle tip's position was identified by direct visualization using the movement of adjacent anatomical structures.
15773349|NCT04668183|Procedure|Dorsal penile nerve block group|Half of the total 0.2 ml/kg dose of 0.25% bupivacaine was administered while observing its distribution with US. The same procedure was then repeated on the other side of the penis.
15773350|NCT04668170|Biological|Blood collection on admission and longitudinally|Samples already collected on admission (day 0) and longitudinally (day 4, 8 12 and in discharge)
15773351|NCT04668170|Biological|Blood collection on their first consultation and 10 to 14 days later|Samples already collected on consultation (D0) and 14 days later
15773352|NCT04668157|Drug|TAK-536|TAK-536 granule formulation
15773353|NCT04668144|Drug|Cangrelor|Cangrelor will be used at the FDA recommended dose using a 30 μg/kg bolus followed by 4 μg/kg/min infusion. The total infusion will last 2 hours.
15773354|NCT04668144|Drug|Prasugrel|Prasugrel will be used in line with FDA recommendations using a 60mg LD followed by a 10mg daily maintenance dose started 24 hours after LD administration
15773355|NCT04668131|Drug|Sodium hyaluronate eye drops|eye drops, three times a day
15773356|NCT04668131|Other|acupuncture|three times a week
15773357|NCT04668118|Drug|Diquafosol|As a P2Y2 receptor agonist, diquafosol can be used to stabilize the tear film by stimulating P2Y2 receptors on the corneal epithelial cells and conjunctival goblet cell, which increase the secretion of tear fluid and mucin on the ocular surface, thereby repairing the ocular surface and stabilizing the tear film.
15773358|NCT04668105|Other|High volume nordic hamstring exercise|To perform Nordic Hamstring Curls, the person will kneel on a pad (for knee comfort) and lower under control, his ankles must be stabilized and kept in a place with the help of a partner, but can also use a moveable object or a loaded barbell can also be used to achieve the stability. The person must then extend his hamstrings in order to lean forward, he should lean forward from the knee and not from the hip. The movement must be kept controlled and slow. The person should go as forward/low as possible but without the help of hands or arms. The only time one can put his hands in front of him is when he can't rely on his legs and then push himself back to starting position and then repeat the procedure again.Group 1 will do the Nordic hamstring exercise with protocol 3 repetitions × 3sets× 3 times for 4 weeks.
15773359|NCT04668105|Other|Low volume nordic hamstring exercise|To perform Nordic Hamstring Curls, the person will kneel on a pad (for knee comfort) and lower under control, his ankles must be stabilized and kept in a place with the help of a partner, but can also use a moveable object or a loaded barbell can also be used to achieve the stability. The person must then extend his hamstrings in order to lean forward, he should lean forward from the knee and not from the hip. The movement must be kept controlled and slow. The person should go as forward/low as possible but without the help of hands or arms. The only time one can put his hands in front of him is when he can't rely on his legs and then push himself back to starting position and then repeat the procedure again. Group 2 will do the Nordic hamstring exercise with protocol 3 repetitions × 3 sets × 1 times for 4 weeks.
15773360|NCT04668092|Other|Functional dry needling|functional dry needling applied to hamstring for 1 minute and post interventional data collected
15773361|NCT04668079|Other|Modified cross body stretch|"Athlete was in side lying positioned. trunk was moved posteriorly 200 to 300 and shoulder is raised to 900 and semi flex both knees. Athlete was ask to passively pull the humerus across the body into horizontal adduction with the opposite hand.
~5 reps once daily 3 sets for 4 weeks was given"
15773362|NCT04668079|Other|Modified sleeper stretch|"Athlete was in side lying positioned on the involved side, trunk was rolled posteriorly 200 to 300 and shoulder is raised to 900 and elbow is flexed to 900 and semiflex both knees. athlete was ask to perform internal rotation passively by using the opposite arm.
~5 reps once daily 3 sets for 4 weeks was given"
15773366|NCT04668053|Other|Hip flexor resistance protocol|"Warm up prior to training The loop bands (Resistance-band©) that were used are in several colors-Red, black, yellow, blue and green extended from strongest type to weakest.
~Athletes executed 3 training sessions of 3 sets per week for 6 weeks.
~The relative load was:
~Week 1----15 RM Week 2-4----10 RM Week 5-6----8 RM The Therapist has ensured a concentric contraction of 3-s, an isometric contraction of 2-s, eccentric contraction of 3-s, rest for 2-s prior to the next repetition and rest for 2-min prior the next set.
~It took 10 min to complete each session, with rest between sets."
15773367|NCT04668040|Other|Muscle energy technique|Muscle energy technique for illiopsoas, rectus femoris, erector spinae & hamstrings muscles duration of contraction was 10 sec, rest interval was 5 sec, stretch duration was 30 sec, number of repetition of stretch was 5, number of set was 1, frequency per week was 3
15773368|NCT04668040|Other|Stretching|Stretching exercises for illiopsoas, rectus femoris, erector spinae & hamstrings muscles duration of stretch was 15 sec, rest interval was 5 sec, number of repetition was 5, number of set was 1, frequency per week was 3
15773369|NCT04668027|Diagnostic Test|impulse oscillation（IOS）|The patient is tested for the first IOS after the screening test, and performed the second IOS test immediately after the results of BPT or BDT. The patient takes seats, body relax, make sure the mouthpiece is fully covered by mouth, then clip nose with both hands to cover both sides of the cheek, and then calms breathing one minutes.
15773370|NCT04668027|Diagnostic Test|bronchial provocation test(BPT)|Patient needs to cooperate with the inhalation of acetylcholine stimulants with low to high concentrations, and operates in accordance with the standard nebulized administration procedure. Measure FEV1 after each inhalation and take the high value. The interval between the inhalation of two adjacent doses is 5 minutes, until the FEV1 decrease value is ≥20% of the FEV1 base value or the highest inhalation concentration. The patient needs to cooperate to ensure that the filter is as tight as possible to prevent air leakage, and performs exhalation and inhalation with the greatest strength and fastest speed. After the examination,the patient should inhale the bronchodilator salbutamol sulfate (400ug).
15773371|NCT04668027|Diagnostic Test|bronchial dilation test(BDT)|The patient inhales the salbutamol sulfate (400ug). 15 minutes later, the pulmonary function tester is used for measurement. The patient needs to cooperate to ensure that the filter is as tight as possible to prevent air leakage, and to exhale and breathe with the greatest strength and fastest speed. Inhale.
15773372|NCT04668001|Device|Near-Infrared Transcranial Photobiomodulation|tPBM-NIR involves the use of a device that administers near-infrared light over the scalp. The light activates target brain regions.
15773373|NCT04668001|Device|Sham Transcranial Photobiomodulation|tPBM-Sham involves the use of an identical device to tPBM-NIR but does not administer near-infrared light. It mimics the sensation by applying heat but does not actually activate target regions of the brain
15773374|NCT04667988|Diagnostic Test|JAK expression|JAK2 assessment in blood by PCR
15773375|NCT04667975|Drug|CKD-702|In principle, based on 1 cycle of 28 days (4 weeks), administer CKD-702 Inj. once every 2 weeks over 4 weeks.
15773376|NCT04667962|Other|Online questionnaire|Participants will have to complete 3 online self-questionnaires: the first one at enrollment, the second one 1 month after enrollment (M1) and the third one 3 months after enrollment (M3). Each questionnaire will take an estimated 20 minutes to complete.
15773377|NCT04667949|Drug|Fingolimod 0.5mg|Subjects will receive fingolimod 0.5mg capsule QD up to month 24
15773378|NCT04667936|Other|Treatment group|None, solely treatment documentation
15773379|NCT04667923|Diagnostic Test|Respiratory monitoring|Measurement of the tidal volume, peak inspiratory flow, inspiratory time, respiratory rate and the pressure gap during triggering on NIV and plateau pressure on mechanical ventilation
15773380|NCT04667923|Diagnostic Test|Respiratory muscles ultrasound|Measurement of the diaphragm thickening fraction, assessment of the contraction of scalene and sternocleidomastoid muscles
15773381|NCT04667923|Diagnostic Test|Electro impedance tomography|Measurement of the lung impedance changes in 4 quadrants, measurement of regional ventilation delay in 4 quadrants
15773382|NCT04667923|Diagnostic Test|Capnography|Measurement of end-tidal carbon dioxide tension
15773383|NCT04667923|Diagnostic Test|Arterial blood gas|Measurement of the oxygen partial pressure and the carbon dioxide partial pressure
15773384|NCT04667923|Diagnostic Test|Quasistatic pressure-volume curve|Quasistatic pressure-volume curve
15773385|NCT04667910|Drug|601 1.25mg|Solution for injection (intravitreal use)
15773386|NCT04667910|Drug|Ranibizuman 0.5 mg|Solution for injection (intravitreal use)
15773387|NCT04667897|Drug|601 1.25mg|Solution for injection (intravitreal use)
15773388|NCT04667897|Drug|Ranibizuman 0.5 mg|Solution for injection (intravitreal use)
15773389|NCT04667884|Dietary Supplement|Prebiotics or Probiotics|All the supplements were provided in solid drinks，and required to drink with plain water 35-40℃, and lifestyle intervention was provided to all the groups by reading materials.
15773390|NCT04667871|Procedure|cataract surgery|Eyes for cataract surgery
15773391|NCT04667858|Device|Home Ovulation Test|Visual read home ovulation test
15773392|NCT04667845|Device|Home Ovulation Test|Digital read home ovulation test
15773393|NCT04667832|Diagnostic Test|selective coronary artery angiography|Radial approach, invasive selective coronary angiography with selective contrast injection and filming in coronary arteries
15773394|NCT04667819|Drug|Sodium Hyaluronate|We usage a special type of anterior eye drug delivery system to conduct the transmission of sodium hyaluronate in dry eye patients.
15773395|NCT04667806|Behavioral|Questionnaires|Use questionnaires ( SF36 questionnaire (generic score) and St Georges's questionnaire (specific score))
15773396|NCT04667793|Drug|Toripalimab|200mg, q3w, i.v., 2-4 cycles
15773397|NCT04667793|Drug|Chemotherapy|Cisplatin+Amycin+Cyclophosphamide
15773398|NCT04667793|Drug|Chemotherapy|Carboplatin+Paclitaxel
15773399|NCT04667780|Drug|Colchicine|Colchicine tablet 0.5 mg
15773400|NCT04667780|Drug|Standard COVID-19 care|As per the hospital guidelines
15773401|NCT04667767|Other|WASH kit|WASH kit containing a plastic container and a supply of Aquatabs® (effervescent chlorine tablets) and training in their use and associated hygiene practices.
15773402|NCT04667767|Other|Standard treatment|National standard outpatient treatment for uncomplicated severe acute malnutrition
15773498|NCT04666948|Drug|Vancomycin|Vancomycin treatment
15773403|NCT04667754|Behavioral|Internet-delivered Cognitive Behavioural Therapy|ICBT provides online structured self-help modules over several months based on the principles of CBT in combination with weekly guidance through emails and telephone calls. The course comprises 6 online lessons that provide psychoeducation about: 1) symptom identification and the cognitive behavioural model; 2) thought monitoring and challenging; 3) de-arousal strategies and pleasant activity scheduling; 4) graduated exposure/pacing; 5) memory and attention; and 6) relapse prevention. Participants will also have the opportunity to ask any questions regarding the content of the program materials and will receive a response from their Guide within 48-72 hours. Guide will spend ~15 mins. per week/per participant. All Guides have completed a university program (psychology or social work) and are registered clinicians or students working under supervision of a registered clinician.
15773404|NCT04667741|Other|Post-dialysis recovery group|Before the hemodialysis session, the patients were asked by the investigators how long it took them to recover from a dialysis session, taking the last treatment month into account.
15773405|NCT04667728|Device|Professional continuous glucose monitoring (CGM) sensor (iPro™2)|Professional continuous glucose monitoring (CGM) sensor (iPro™2) following treatment adjustments and personalized diet plan
15773406|NCT04667715|Device|Exablate BBBD|Blood brain barrier disruption using ExAblate Type 2 device using microbubble resonators
15773407|NCT04667702|Behavioral|Interviews|We will conduct a phone or virtual interview with patients with sickle cell disease or cancer, caregivers and their healthcare providers.
15773408|NCT04667689|Behavioral|CAMPFIRE Online Cognitive Assessment for Cancer Patients|Subjects will complete PROMIS Cognitive Function/Anxiety/Depression survey assessments and a short neuropsychological battery (NIH Toolbox) on an iPad while in clinic prior to beginning chemotherapy, again before a clinic visit scheduled between 6 - 9 weeks and, lastly, before a post-chemotherapy follow-up clinic visit. Within two weeks of their post-chemotherapy assessment, subjects will be asked to complete a feedback survey. The physician providers and/or their clinical team (e.g., nurse practitioners, registered nurses) will be asked to review subjects' cognitive assessment results and discuss referrals and/or recommendations, if appropriate.
15773409|NCT04667676|Device|acupoint TENS|TENS was applied bilaterally on acupoint Ex-B1, 4Hz frequency, and 200 μs pulse width and intensity was set at the best highest tolerable intensity by the patient sensitivity without a sensation of discomfort for 45 minutes, three times/week for four weeks
15773410|NCT04667663|Drug|Daratumumab|Daratumumab (1,800mg) will be administered by a subcutaneous injection once every week for 2 cycles (Cycles 1-2), then once every 2 weeks for 4 cycles (Cycles 3-6), and following this (Cycle 7 onwards), patients will receive daratumumab once every four weeks.
15773411|NCT04667663|Drug|Cyclophosphamide|Cyclophosphamide will be administered PO at 50mg daily for all cohorts in the study.
15773412|NCT04667663|Drug|Pomalidomide|Pomalidomide will be administered PO on days 1-21 of each 28 day cycle. The dose will be specified by the dose level to which the patient has been enrolled.
15773413|NCT04667663|Drug|Dexamethasone|Dexamethasone will be administered PO at 40mg on days 1, 8, 15 and 22 of each 28 day cycle.
15773414|NCT04667650|Other|Use of nomogram for predictions of Ocular Mysathenia Gravis generalization|The outcome measure was time to Myasthenia gravis generalization. The explanatory variables were age at onset, sex, first-year anti-acetylcholinereceptor antibody positivity, repetiting nerve stimulation showing electromyogram decrement and steroid use. Kaplan-Meier survival estimations, descriptive and multivariate Cox model analyses were computed. A nomogram combining explanatory vraiables was used to establish a score to predict the probability of OMG generalization.
15773415|NCT04667637|Drug|edaravone dexborneol|Intravenous injections of edaravone dexborneol (37.5mg, dissolved in 100ml saline) twice a day for 12 ±2 days.
15773416|NCT04667624|Drug|Twynsta|Manufactured by Boehringer Ingelheim
15773417|NCT04667624|Drug|LodineT|•Manufactured by Hanlim Pharm. Co., Ltd, Seoul, Korea
15773418|NCT04667611|Behavioral|Psychosocial interventions|Cognitive behavioural therapy (CBT) based individual and group intervention
15773419|NCT04667598|Drug|Modified Wenxin Decoction|Mainly including make aconite , astragalus ， Cassia twig , dried ginger , red peony root , Chuanxiong , Codonopsis codonopsis , Ophiopogon ophiopogon , Schisandra , Stamen , Asarum , licorice.
15773420|NCT04667585|Radiation|De-escalated radiation dose|Reduced dose of radiation applied to remaining radiation therapy when favorable interim PET-CT signature is produced
15773421|NCT04667585|Radiation|Standard radiation dose|Standard dose of radiation applied to remaining radiation therapy when favorable PET-CT signature is not produced
15773422|NCT04667585|Other|18 fluorodeoxyglucose (FDG)-positron emission tomography (PET)-Computed Tomography (CT)|The CT scan - also called computerized tomography or just CT - combines a series of X-ray views taken from many different angles to produce cross-sectional images of the bones and soft tissues inside the body. CT scans in planning radiation therapy are standard of care. A PET is a highly specialized imaging technique that uses short-lived radioactive substances (such as FDG a simple sugar labeled with a radioactive atom) to produce three-dimensional colored images of those substances functioning within the body. These images are called PET scans and the technique is termed PET scanning. PET scanning provides information about the body's chemistry not available through other procedures. Unlike CT or MRI (magnetic resonance imaging), techniques that look at anatomy or body form, PET studies metabolic activity or body function.
15773423|NCT04667572|Combination Product|PXL-330 Platinum device for crosslinking with Peschke riboflavin solution|Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea
15773424|NCT04667559|Device|Conformis iTotal Identity Knee Replacement System|The iTotal® Identity KRS is a tri-compartmental semi-constrained knee prosthesis composed of three components: a Femoral Component, a Tibial Component, and a Patellar Component.Using patient imaging, a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. The treatment allows for the placement of a cemented metallic device designed from the patient's natural bone geometry. This process allows definition of the shape and size of the femoral and tibial components of the implant, as well as the disposable instrumentation.
15773425|NCT04667546|Other|Survey|Patients or their parents will complete a survey at D2, D5, D10 and D28 to assess the presence or absence of a symptom
15773426|NCT04667533|Drug|Desidustat|"A total of 24 participants will be enrolled.
~The study is divided into three cohorts as given below:
~Cohort I: Single-dose 100 mg
~Cohort II: Single-dose 150 mg
~Cohort III: Single-dose 200 mg"
15773539|NCT04666675|Drug|Placebo for Upadacitinib|Oral; Tablet
15773428|NCT04667520|Behavioral|Fitbit Only|Participants are provided with a Fitbit during their study participation.
15773429|NCT04667507|Drug|Dexamethasone Ophthalmic implant|Dexamethasone ophthalmic insert 0.4 mg for intracanalicular use
15773430|NCT04667494|Combination Product|Sonotherapy|Use of high mechanical index ultrasound therapy with intravenous Definity contrast infusion
15773436|NCT04667468|Biological|Cold Stored Platelets (CSP)|early infusion of urgent release CSP
15773437|NCT04667468|Biological|Standard Care|standard care including blood and blood component therapy
15773438|NCT04667455|Diagnostic Test|Biomarker analysis at enrolment|Controls will be compared to cases using biomarker analyses and non-invasive cardiac imaging techniques to improve risk stratification of cases
15773439|NCT04667455|Diagnostic Test|Biomarker analyses throughout the study|Controls will be compared to cases using biomarker analyses and non-invasive cardiac imaging techniques to improve risk stratification of cases
15773440|NCT04667442|Diagnostic Test|Nanomix eLab® COVID-19 Rapid Antigen Panel (non-interventional)|COVID-19 Rapid Antigen Diagnostic Test
15773441|NCT04667429|Other|Food|HEC83518 40mg will be taken orally fasted or with food
15773442|NCT04667429|Drug|HEC83518|HEC83518 will be taken orally before sleep for 15 days
15773443|NCT04667429|Drug|placebo|The placebo will be administered before sleep for 15 days.
15773444|NCT04667416|Biological|PalinGen Flow Amniotic Tissue Allograft|Participants will receive wound size-dependent dose of PalinGen Flow liquid human amniotic tissue allograft by subcutaneous injection in addition to SOC.
15773445|NCT04667403|Other|Telemedicine|"In addition to his standard follow-up, the patient benefits from a home follow-up of his pain for 6 months from his inclusion in the study.
~The patient has to log on via the application, every week. to fill in the questionnaire to evaluate the pain over the past week.
~The questionnaire consists of 4 questions to which the patient answers using a numerical scale from 0 to 10.
~If the patient's pain is not controlled, the patient can log on in emergency mode as many times as he or she deems necessary.
~A nurse path coordinator will be informed of each connection. Depending on the type of alert received, she may initiate a telephone consultation with the oncologist or pain specialist:
~If necessary within 24 hours of the connection if it is a weekly connection,
~Systematic within 3 hours if it is an emergency connection or if the data entered at the time of the weekly connection requires medical intervention."
15773446|NCT04667390|Other|total knee arthroplasty|total knee arthroplasty
15773447|NCT04667377|Drug|BI 456906|BI 456906
15773448|NCT04667377|Drug|Placebo|Placebo
15773449|NCT04667364|Device|Transcutaneous electrical nerve stimulation (TENS)|Conventional TENS will be performed using two electrodes placed on the involved extremity and with the following stimulation parameters; a frequency of 100 Hz, pulse duration 50-100 ms, and at an intensity gradually increased until the patient feels a strong, tolerable and non-painful sensation (18, 19). The intensity is incrementally increased based on patient feedback. Patients will receive guidelines on how to use the TENS device at home and will over a period of 30 days self-administer TENS as needed. Patients is to fill out a predefined schedule on paper each day to monitor dose.
15773450|NCT04667351|Drug|2400 mg/m² 5-fu|Hepatic arterial infusion of oxaliplatin,leucovorin and 2400 mg/m² 5-FU
15773451|NCT04667351|Drug|1200 mg/m² 5-fu|Hepatic arterial infusion of oxaliplatin,leucovorin and 1200 mg/m² 5-FU
15773452|NCT04667312|Drug|Durvalumab|Durvalumab
15773453|NCT04667299|Drug|Rabeprazole|20mg bid
15773454|NCT04667299|Drug|Bismuth potassium citrate|0.6g bid
15773455|NCT04667299|Drug|Metronidazole|0.4g qid
15773456|NCT04667299|Drug|Amoxicillin|1g bid
15773457|NCT04667286|Procedure|Prone Position (PP)|Prone the patients on oxygen for at least 10 hrs a day
15773458|NCT04667273|Procedure|Neuromuscular Electrical Stimulation (NMES)|"In Neuromuscular Electrical Stimulation (NMES) application, 4 surface electrodes will be placed in the swollen part of the lower trapezius and serratus anterior muscles of each patient.
~NMES will be applied for 20 minutes in rehabilitation mode with a 4-channel device.
~Frequency: 80 Hz Amplitude: 0-100 mA (0-0.01 V) Current time-Pulse: 200 μsec Wave form: Biphasic Cycle time: 8 seconds of tetanic muscle stimulation for all patients, with a 2 second rise and fall time and stimulation It will be set as 3 seconds between. It is important to visually observe the contraction to determine the intensity of stimulation."
15773459|NCT04667273|Procedure|Exercise Training (ET)|"Patients will do Wand exercises under the supervision of a physiotherapist. Wand exercises will include shoulder flexion, external rotation and abduction in the scaption position. In the first and second week, these exercises will be performed on the back, and from the third week on standing exercises.
~Exercises with the Theraband will be done in 3 sets, each set will consist of 10 repetitions. There will be a 1 minute rest period between sets. When the three sets are easily completed and there is no reported fatigue by the patient, the resistance will be increased by moving from yellow to red, from red to green, respectively, after 4 weeks.
~*For shoulder external rotators and serratus anterior muscles are strengthened without weight for the first 2 weeks, then 0.5 kg of dumbbells, in the supine position.
~While standing, the lower trapezius, upper trapezius and shoulder external rotators will be strengthened with theraband."
15773460|NCT04667260|Procedure|Maxillary sinus membrane elevation|Maxillary sinus membrane elevation with blood coagulum
15773461|NCT04667260|Procedure|Maxillary sinus floor augmentation|Maxillary sinus floor augmentation with 1:1 autogenous bone graft and deprotinized porcine bone mineral
15773462|NCT04667247|Drug|FoTv|8 capsules three times a day for 14 consecutive days.
15773464|NCT04667221|Device|Active transcranial direct current stimulation|A high-definition tDCS set-up will be used with a battery-driven stimulator (Starstim 8, Neuroelectrics). Active stimulation will be conducted with 1.5 milliampere (mA) with two electrodes using three reference electrodes for each active one for 20 minutes.
15773540|NCT04666649|Drug|Venetoclax and pegcrisantaspase|Therapeutic
15773465|NCT04667221|Device|Sham transcranial direct current stimulation|A high-definition tDCS set-up will be used with a battery-driven stimulator (Starstim 8, Neuroelectrics). Sham stimulation will have a 40 seconds ramp-up and down. No stimulation will be applied after this 40 seconds.
15773466|NCT04667195|Other|Clinical assessment|"Within 4 hours of admission to the emergency department, clinical assessment will include:
~Demographics,
~comorbidity,
~symptoms,
~objective findings,
~triage at admission,
~blood test results,
~urine test results"
15773467|NCT04667182|Other|Meal-Tagging App and Web-based Portal:|Meal tagging app to capture frequently eaten meals and test meals for 18 weeks.
15773468|NCT04667182|Device|Fitness Tracker|Fitness tracker will be worn around the clock for 18 weeks.
15773469|NCT04667169|Procedure|Haemorrhoidal Artery Ligation|Post-operatively, all subjects were given tablet Paracetamol 1 gm six hourly and Capsule Celecoxib 200 mg 12 hourly as pain control for five days. They were given Syrup Lactulose 15 cc 12 hourly for one week to prevent constipation. Subjects were discharged on the same day or one day after surgery. All patients were assessed in the clinic by a nurse/medical officer blinded to the type of procedure performed on post-operative 24 hours, one week and six weeks.
15773470|NCT04667169|Procedure|Laser Haemorrhoidoplasty|Post-operatively, all subjects were given tablet Paracetamol 1 gm six hourly and Capsule Celecoxib 200 mg 12 hourly as pain control for five days. They were given Syrup Lactulose 15 cc 12 hourly for one week to prevent constipation. Subjects were discharged on the same day or one day after surgery. All patients were assessed in the clinic by a nurse/medical officer blinded to the type of procedure performed on post-operative 24 hours, one week and six weeks.
15773471|NCT04667156|Drug|SHR6390|SHR6390 new formulation 1(T1) , SHR6390 new formulation 2 (T2) and SHR6390 traditional formulatin were given in a single dose over three cycles
15773472|NCT04667143|Drug|Retagliptin, Henagliflozein, metformin XR|Retagliptin-DPP4 inhibitor Henagliflozein-SGLT-2 inhibitor Metformin XR
15773473|NCT04667130|Behavioral|Preventive Complex Program for Newly Diagnosed People With Multiple Sclerosis|Preventive program included informations of the possibilities of physiotherapy in the treatment of multiple sclerosis focused on fatigue management - recommending lifestyle changes. Program included a the treatment of psychosomatic, viscerosomatic functional disorders by reflexively poor connection through the locomotor system using computer kinesiology, psychotherapy, manual therapy - where patients are corrected into a postural position and the joints are functionally centred, and aerobic exercise to influence fatigue and improve the performance of the cardiovascular system.
15773474|NCT04667117|Biological|Quadrivalent influenza vaccine|2020-2021 inactivated quadrivalent influenza vaccine
15773475|NCT04667117|Drug|Ofatumumab|"Auto-injector containing 20 mg sc ofatumumab (20 mg/0.4ml) for subcutaneous administration.
~Novartis will supply participants in Cohort 1 with ofatumumab treatment in the Investigational Period and the optional 6-month Extension Period.
~Participants in Cohort 2 will continue on their commercially prescribed ofatumumab treatment during the Investigational Period. Novartis will supply participants in Cohort 2 with ofatumumab treatment in the optional 6-month Extension Period."
15773476|NCT04667104|Drug|JNJ-73763989|JNJ-73763989 injection will be administered subcutaneously once every 4 weeks.
15773477|NCT04667104|Drug|JNJ-56136379|JNJ-56136379 tablets will be administered orally once daily.
15773478|NCT04667104|Drug|Tenofovir disoproxil|Tenofovir disoproxil film-coated tablet will be administered orally once daily.
15773479|NCT04667104|Drug|Tenofovir alafenamide (TAF)|TAF film-coated tablet will be administered orally once daily.
15773480|NCT04667104|Drug|Entecavir (ETV) monohydrate|ETV monohydrate film-coated tablet will be administered orally once daily.
15773481|NCT04667104|Drug|PegIFN-alpha2a|PegIFN-alpha2a injection will be administered subcutaneously once weekly.
15773482|NCT04667091|Other|Physiotherapy|"Treatment will be given in 3 sessions per week for 6 weeks with home exercise program and participants will be provided with exercises sheets to remember the exercises.
~The selected outcome measure will be taken on baseline (initial visit) and 6th week (post intervention)"
15773483|NCT04667078|Drug|Cangrelor|administration of cangrolor by iv befor thrombectomy
15773484|NCT04667078|Other|best medical management|used yhe best medical management
15773485|NCT04667065|Other|Physical activity|Physical activity with the remotely guidance of physical activity teachers
15773486|NCT04667052|Drug|JNJ 64304500|Participants will receive a single subcutaneous dose of JNJ-64304500 reference formulation.
15773487|NCT04667052|Drug|JNJ 64304500|Participants will receive a single subcutaneous dose of JNJ-64304500 test formulation.
15773490|NCT04667013|Drug|Tetramethylpyrazine nitrone (TBN) tablet / Placebo|Subjects will be administered multiple oral doses of TBN or matching placebo tablets twice a day for 6 consecutive days and a last dose in the morning of Day 7.
15773491|NCT04667000|Other|Forced Air Warming|We will use Forced Air Warming for cesarean patient
15773492|NCT04666987|Drug|Insulin degludec and liraglutide (IDegLira)|Paricipants will be treated with commercially available Xultophy® according to routine clinical practice at the discretion of the treating physician, following approved label in Italy. The decision to initiate treatment with commercially available Xultophy® has been made by the patient and the treating physician before and independently from the decision to participate in this study.
15773493|NCT04666974|Behavioral|iCBT|Online CBT modules will be completed weekly with content mirroring in-person CBT for their diagnosis. Homework will be submitted weekly through the OPTT platform which will be reviewed by a trained professional who will provide personalized feedback.
15773494|NCT04666974|Behavioral|In-Person CBT|Participants will be assigned to in-person CBT that will mirror the content and homework covered in the iCBT group. It will be delivered by professionals and attended weekly.
15773495|NCT04666961|Drug|Tamoxifen 20 mg|Tamoxifen will be initiated in non menopausal patients orally for 6 months in a neoadjuvant situation.
15773496|NCT04666961|Drug|Anastrozole 1Mg Tab|Anastrozole will be initiated in menopausal patients orally for 6 months in a neoadjuvant situation.
15773497|NCT04666948|Device|vancomycin model-informed precision dosing|A CE labelled dosing calculator is used for a priori and a posteriori calculation of vancomycin dose using a target AUC between 400-600 mg*h/L
15773499|NCT04666935|Other|The Oslo Sports Trauma Research Center (OSTRC) Injury Prevention Program|Sport Injury Prevention Program.
15773500|NCT04666935|Other|Usual warm up|Usual warm up is defined as any basic exercises performed before a performance or practice to prepare the muscles for vigorous actions.
15773501|NCT04666922|Drug|BI 765080|BI 765080
15773502|NCT04666922|Drug|Placebo|Placebo; 0.9% saline for injection
15773503|NCT04666909|Diagnostic Test|blood pressure|"The Welch Allyn ABPM 7100 is an easy-to-use 24-hour ambulatory blood pressure monitor that is designed to help avoid the effects of white coat hypertension, provide accurate sleep blood pressure readings, and tailor drug therapy regimes to your individual patient's needs.
~This device is programmed to take three BP readings a minute apart. To be eligible, participants must have an average SBP > 135 mm Hg or DBP > 85 mmHg (based on the average of 3 BP readings); or average SBP > 130 mm Hg or DBP > 80 mm hg (for those with diabetes or kidney disease) based on JNC-7 criteria for uncontrolled HTN."
15773504|NCT04666896|Other|Tailored home-based exercise therapy|exercises were divided into four types: 1) shrug exercises; 2) external rotation exercises; 3) bench slides; and 4) wall slides.
15773505|NCT04666896|Other|Standard home-based exercise therapy|The exercise program consisted of 4 types of exercises for training 1) balance and proprioception; 2) isometric strength; 3) rotator cuff muscles; and 4) open chain elevation
15773506|NCT04666883|Other|Review of records and follow up|Follow up to identify patients who developed splenic hilar nodal metastases
15773507|NCT04666870|Other|myopia or not myopia|visual acuity, IOL master biometry, the anterior segment with slit lamp, dilated fundus examination and refraction.
15773508|NCT04666857|Other|early motor intervention|infants with CHD after open heart surgery will receive early intervention
15773509|NCT04666844|Other|no intervention|Observational Study
15773510|NCT04666831|Behavioral|Adapted Motivational Interviewing (AMI) and Cognitive Behavioural Therapy (CBT)|The intervention combines AMI techniques as described by Miller and Rollnick (2013) in the third edition of their Motivational Interviewing book, as well as CBT techniques from the Tele-CBT protocol for bariatric surgery patients by Cassin et al. (2013).
15773511|NCT04666818|Device|Use of Flash Glucose Monitoring|Participants in the intervention group were advised to monitor glucose levels by means of flash glucose system.
15773512|NCT04666805|Drug|Tamoxifen|20 mg/d, oral administration
15773513|NCT04666805|Drug|Toremifene|60 mg/d, oral administration
15773514|NCT04666805|Drug|Anastrozole|1 tablet (1 mg) per day, oral administration
15773515|NCT04666805|Drug|Letrozole|Adjuvant therapy with letrozole for 5 years or until the disease relapses. Patients who have received tamoxifen adjuvant therapy for 5 years should continue to take Letrozole until the disease relapses. The recommended dose of Letrozole tablets is one 2.5 mg tablet administered once a day, without regard to meals. For patients with advanced breast cancer, treatment with Letrozole should continue until tumor progression is confirmed. Patients with liver and/or renal dysfunction (creatinine clearance rate ≥ 10 mL/min) do not need to adjust the dosage.
15773516|NCT04666805|Drug|Exemestane|The recommended dose of Exemestane for adult and older patients with early and advanced breast cancer is one 25 mg tablet administered orally once a day after a meal. After 2-3 years of tamoxifen treatment, patients with early breast cancer should continue to use Tamoxifen in the case of no recurrence or contralateral breast cancer, until the completion of 5-year sequential adjuvant therapy with tamoxifen and exemestane. Patients with advanced breast cancer should continue to take Exemestane until the tumor progresses.
15773517|NCT04666792|Drug|PrEP|A fixed-dose, oral co-formulation of emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) is the approved and preferred regimen for HIV-1 prevention in Kenya and the United States. The World Health Organization (WHO) recommends TDF-containing medications as PrEP, which includes TDF combined with FTC as well as potentially TDF alone and TDF combined with lamivudine (or 3TC, a medication closely related to FTC). Any TDF-containing medications that align with WHO and Kenya national guidelines for PrEP will be used. PrEP medication will come from clinic stocks.
15773518|NCT04666779|Other|Chiropractic care|Care provided by chiropractors, based on manual therapy, exercise prescription and patient advice/education/reassurance
15773519|NCT04666766|Device|Microwave scanning of the head|A scan of the head will be performed with a microwave device to ascertain the likelihood of intracranial hemorrhage.
15773520|NCT04666753|Dietary Supplement|ImmunoFormulation|The ImmunoFormulation consist of: transfer factors (oligo- and polypeptides from porcine spleen, ultrafiltered at <10 kDa - Imuno TF®) 100 mg, 800 mg anti-inflammatory natural blend (Uncaria tomentosa, Endopleura uchi and Haematoccocus pluvialis - MiodesinTM), 60 mg zinc orotate, 48 mg selenium yeast (equivalent to 96 μg of Se), 20,000 IU cholecalciferol, 300 mg ascorbic acid, 480 mg ferulic acid, 90 mg resveratrol, 800 mg spirulina, 560 mg N-acetylcysteine, 610 mg glucosamine sulphate potassium chloride, and 400 mg maltodextrin-stabilized orthosilicic acid (equivalent to 6 mg of Si - SiliciuMax®).
15773521|NCT04666740|Drug|Pembrolizumab|Pembrolizumab 200 mg IV every 3 week. After the first 6 months (8 cycles), on C9D1 Pembrolizumab 400 mg IV every 6 week.
15773522|NCT04666740|Drug|Olaparib|Olaparib 300 mg twice day orally daily continuously (POLAR) as a maintenance therapy. After the first 6 months (8 cycles), on C9D1 olaparib 300 mg twice a day orally will be continued.
15773523|NCT04666714|Drug|Praga formulation|Praga formulation tablet
15773524|NCT04666714|Other|Placebo pregabalin 75mg|Placebo pregabalin 75mg tablet
15773525|NCT04666714|Other|Placebo Pregabalin 150mg|Placebo Pregabalin 150mg tablet
15773526|NCT04666714|Drug|Pregabalin 75mg|Pregabalin 75mg tablet
15773527|NCT04666714|Drug|Pregabalin 150mg|Pregabalin 150mg tablet
15773528|NCT04666714|Other|Placebo Praga formulation|Placebo Praga formulation tablet
15773529|NCT04666701|Drug|Escócia association|Escócia association tablet
15773530|NCT04666701|Other|Placebo Ketorolac|Placebo Ketorolac tablet
15773531|NCT04666701|Other|Placebo Scopolamine|Placebo Scopolamine dragee
15773532|NCT04666701|Drug|Ketorolac Tromethamine|Ketorolac tablet
15773533|NCT04666701|Drug|Scopolamine|Scopolamine dragee
15773534|NCT04666701|Other|Placebo Escócia association|Placebo Escócia association tablet
15773535|NCT04666688|Drug|LYT-200|monoclonal antibody (mAb), targeting galectin-9 protein
15773536|NCT04666688|Drug|Anti-PD-1|anti-PD-1 monoclonal antibody
15773537|NCT04666688|Drug|Gemcitabine/nab-paclitaxel|chemotherapy
15773538|NCT04666675|Drug|Upadacitinib|Oral; Tablet
15773541|NCT04666636|Drug|Placebo|Participants will take one pill (placebo) daily for the first week and two pills daily for the remaining 15 weeks.
15773542|NCT04666636|Drug|Mirabegron|Participants will take one pill (50mg Mirabegron) daily for the first week. For week two, participants will take two pills (50mg and 25mg Mirabegron). Unless there are side effects, for the remaining 14 weeks participants will take two pills (50mg each) daily.
15773543|NCT04666623|Drug|esketamine nasal spray|unlabeled nasal injectors, each device will deliver 28mg of esketamine in a 200 μL solution, so in order to achieve the 56mg dose two devices will be required. On each dosing day during the trial, participants will self-administer at 2 time points 1 spray of the nasal spray into each nostril. Each administration will be separated by 5 minutes. The participants will receive the intervention twice weekly for 4 consecutive weeks.
15773544|NCT04666623|Drug|placebo nasal spray|unlabeled nasal injectors, each device will deliver 28mg of placebo in a 200 μL solution, so in order to achieve the 56mg dose two devices will be required. On each dosing day during the trial, participants will self-administer at 2 time points 1 spray of the nasal spray into each nostril. Each administration will be separated by 5 minutes. The participants will receive the intervention twice weekly for 4 consecutive weeks.
15773545|NCT04666610|Drug|Brivaracetam|"Pharmaceutical form: Oral solution
~Route of administration: Oral use
~Brivaracetam (oral solution [10 mg/ml, 5 mg/ml or 2.5 mg/ml] will be administered."
15773546|NCT04666610|Other|Placebo|Subjects will receive placebo at pre-specified time-points to maintain the blinding.
15773547|NCT04666597|Procedure|Modified CariesCare International management|"Management plan will be determined according to 4D cycle of CCI modified system adapted for the pandemic period (non-aerosol generating procedures- Non-AGP).
~The baseline data will include:
~D-DETERMINE risk assessing the protective and risk factors (social/medical/behavioural and clinical), using remote tools. Additionally, the description of tooth brushing behaviours and consumption of free sugars is included.
~D-DETECT & ASSESS: Caries staging and activity: ICDAS-merged visual criteria Caries OUT (without using compressed air, and avoiding radiographs). Clinical risk factors are assessed as well.
~D-DECIDE a personalized care plan: individually designed for caries management home and clinical approaches.
~D-DO: Appropriate Tooth-preserving & Patient-level caries: Management plan at the Patient and at the Lesion level and the implementation of the Change Behaviour Tool (CBT) designed for this protocol.
~The follow-up data will include a T1, T2 and T3 assessment."
15773548|NCT04666584|Device|ScoreFlex balloon|Pre-dilatation with a ScoreFlex balloon
15773549|NCT04666584|Device|Device: standard non-compliant balloon|Pre-dilatation with a standard non-compliant balloon
15773550|NCT04666571|Device|TOKA|The device is a digitally planned (using individual CT scan measured anatomic data) personalised opening wedge high tibial osteotomy (HTO) procedure using a custom 3D printed surgical guide and plate.
15773551|NCT04666571|Device|Tomofix|The Tomofix device is used in more than 80% of HTO procedures reported upon in the United Kingdom Knee Osteotomy Register Annual Report 2018. The Tomofix procedure is similar to the TOKA procedure; however, it is not patient specific and does not use custom-made plates or jigs.
15773552|NCT04666558|Other|Exercise & Nutrition|App-based live group exercise classes, personalized follow-up asynchronous workouts, live group nutrition classes, and protein tracking.
15773553|NCT04666558|Other|Exercise & Nutrition|App-based live group exercise classes, personalized follow-up asynchronous workouts, live group nutrition classes, and protein tracking. Additional one-one-one exercise and nutrition support is provided too.
15773554|NCT04666545|Behavioral|MuST AKT|A behavioural intervention designed to help participants identify and communicate with their social network about living kidney donation.
15773555|NCT04666519|Diagnostic Test|Zonulin Biomarker|During revision hip and knee surgery, discarded fluid/blood will be tested for the presence of zonulin biomarkers
15773556|NCT04666506|Other|Virtual reality|"The VR intervention, Relaxation-VR, is a VR application developed by Psylaris aiming to reduce anxiety/stress and pain by distracting the patient in a relaxing environment. Relaxation-VR will be administered via a commercially available VR headset (Oculus Go). The VR headset is a piece of equipment that a person wears over their eyes that allows them to experience images and sounds produced by a computer as if they were part of real life (Cambridge Dictionary, 2020). As such, the patient is immersed in a novel, calming and distracting environment where the he/she is asked to perform tasks that will help the patients to relax when distressed before and/or during a medical procedure or during their stay in hospital.
~The Relaxation-VR application consists of three modules: two modules make use of relaxation principles (i.e. breathing exercises, meditation) and one module presents a scene with different interactive animations and objects (i.e. popping bubbles, playing fetch with a dog)."
15773557|NCT04666493|Other|Cognitive behavior therapy (CBT), specifically using the Facing Your Fears (FYF) curriculum|The Facing Your Fears program (FYF; Reaven et al. 2011) is a CBT-based group treatment program that has been adapted for the needs of children with high-functioning ASD. The current project will adapt the FYF program for virtual delivery and examine its effectiveness.
15773558|NCT04666480|Device|Transcatheter mitral valve repair|Transvenous approach with a transeptal puncture to place the study device
15773559|NCT04666467|Device|Transcatheter mitral valve repair|Transvenous approach with a transeptal puncture to place the study device
15773560|NCT04666454|Drug|Adenosine|Adenosine infusion 70 µg/kg/min for 3 hours.
15773561|NCT04666454|Drug|Dipyridamole 200 mg|200 mg b.i.d
15773562|NCT04666454|Drug|Apixaban 5 mg Oral Tablet|5mg b.i.d
15773563|NCT04666454|Other|Care as recommended by the Taskforce on Takotsubo Syndrome of the Heart Failure Association of the European Society of Cardiology for takotsubo syndrome|This treatment will vary depending on local routines and the degree of adherence to the recommendations.
15773564|NCT04666441|Drug|REGN10933+REGN10987 combination therapy|Administered IV or SC single dose
15773565|NCT04666441|Drug|Placebo|Administered IV or SC single dose to match
15773566|NCT04666415|Other|Osteopathic treatment|Targeted osteopathic protocol for AN : 5 sessions of osteopathic treatment that are spaced around one week between 2 sessions. Soft specific palpatory techniques on the diaphragm, digestive system and cervical region will be realized during the session of 25 minutes.
15773567|NCT04666402|Other|Blood tests for Single Nucleotide Polymorphisms|This extra test would be performed on participants assessed in the specialist liver clinic. This test would require an extra 5ml of blood to be taken at the time of routine blood tests for clinical purposes.
15840082|NCT04123405|Drug|Placebo|Placebo to acetylcysteine
15773568|NCT04666402|Diagnostic Test|Faecal microbiome analysis|This test will be undertaken for all participants who give consent and are assessed through the new liver care pathway, in the community liver assessment clinic. All participants will be given the equipment to take a stool sample at the time of presentation at the community liver assessment clinic and asked to return the sample to the clinic. The sample will be processed to remove genetic material so the microbiome can be identified.
15773569|NCT04666402|Diagnostic Test|Serum for diagnostic biomarkers|Blood samples will be taken alongside blood taken for clinical assessment. In total, an extra 5ml of blood. These samples will be used to explore novel blood biomarkers using ELISA and mass-spectroscopy techniques in the University of Manchester.
15773570|NCT04666389|Drug|Atorvastatin|To compare the preventive role of low- and high-dose statin regimens in the prevention on contrast-induced acute kidney injury in statin-naive patients with cardiovascular diseases undergoing computer tomography with intravenous contrast media administration
15773571|NCT04666376|Other|evaluation of the effectiveness of vitrification technique on ovarian tissue quality|there are 3 types of experiments in each group, including Follicle survival evaluation by Neutral red staining, Histological evaluation by Hematoxylin and Eosin staining, 2.4. Evaluation GDF-9 and Caspase-3 gene expression by real-time PCR.
15773572|NCT04666363|Other|Lavender oil|the essence was diluted 1:10 with sweet almond oil. A cotton ball soaked in 3 drops of diluted lavender essence was kept at a 10 cm distance from the patients' nose and they were asked to breathe slowly for 5 min.
15773573|NCT04666350|Other|to assess the consistency and reproducibility of two consecutive direct skin feeding assays (DSFA) at 24-hour interval.|"The results from this experimental medicine study will inform whether the preferred Before-After trial design in which each human volunteer serves as their own internal control can be utilized for a follow-on Phase 2b trial."
15773574|NCT04666337|Procedure|ultrasound-guided supraclavicular brachial plexus blockade|Ultrasound-guided supraclavicular brachial plexus block was done using an ultrasound machine (Philips; Model: OTD020, AcBel Polytech Inc., Taiwan) with a 5-10 MHz linear probe. The brachial plexus and its relation to the surrounding structures were viewed while the patient was supine and the head turned 45° to the contralateral side. In the supraclavicular fossa, the probe was placed in the coronal plane to visualize the subclavian artery and the brachial plexus in a transverse sectional view. After skin sterilization and local anesthetic administration, an insulated needle was then introduced lateral to the ultrasound probe and parallel to the long axis of the probe. Once the needle penetrated the brachial plexus cluster, the local anesthetic mixture was injected incrementally after negative aspiration for blood or air just next to the artery, then the needle was repositioned to inject on the upper pole of the artery.
15773575|NCT04666324|Drug|Simethicone Solution|Oral daily treatment for four weeks
15773576|NCT04666324|Dietary Supplement|Multilac Baby|Oral daily treatment for four weeks
15773577|NCT04666311|Diagnostic Test|Accuracy of CAD4TB and Afinion CRP assay for pulmonary TB|"CAD4TB version 6 and 7: Software tool for detecting lung abnormalities in computer tomogram images (pulmonary abnormalities) and frontal chest radiograph images (tuberculosis abnormalities) ; availability is guaranteed by Delft Imaging System; EC 0344 Certificate (vs.6); CE mark pending (vs.7). Will be performed by a registered and qualified radiographer in accordance with national regulations.
~Afinion AS100 Analyzer and Afinion CRP: In vitro diagnostic to determine the amount of CRP in human whole blood, serum or plasma; CE-mark ; Will be performed by qualified, GCP-trained study personnel."
15773578|NCT04666311|Diagnostic Test|CAD4COVID+WBC and COVID-19 RDT for SARS-CoV-2 infection|"CAD4COVID: Non-commercial product. Software tool for detecting pneumonia-related features to be expected in COVID-19 patients; availability is guaranteed by Delft Imaging System; CE certified. Will be performed by a registered and qualified radiographer/health professional in accordance with national regulations. Analysis in combination with differential white blood cell count.
~SD Biosensor, STANDARDTM Q COVID-19 Ag Test (rapid chromatographic immunoassay for the qualitative detection of specific antigens to SARS-CoV-2)"
15773579|NCT04666298|Drug|Inclisiran sodium|Subcutaneously injected on Day 1, 90 and 270.
15773580|NCT04666298|Drug|Placebo|Subcutaneously injected on Day 1, 90, and 270.
15773581|NCT04666285|Other|Experience of pandemic|Experience of the pandemic will be studied through online questionnaire responses
15773582|NCT04666272|Drug|dabrafenib|There is no treatment allocation. Patients administered dabrafenib alone by prescription that have started before inclusion of the patient into the study could be enrolled.
15773583|NCT04666272|Drug|trametinib|There is no treatment allocation. Patients administered trametinib alone by prescription that have started before inclusion of the patient into the study could be enrolled.
15773585|NCT04666233|Procedure|Neonatal resuscitation with PPE for the prevention of SARS-Cov-2 infection|The team will perform neonatal resuscitation with PPE for the prevention of SARS-Cov-2 infection
15773586|NCT04666233|Procedure|Neonatal resuscitation without PPE for the prevention of SARS-Cov-2 infection|The team will perform neonatal resuscitation without PPE for the prevention of SARS-Cov-2 infection
15773587|NCT04666220|Other|VETC evaluation|We will evaluate VETC presence on tissue specimens
15773588|NCT04666207|Diagnostic Test|PCR|RT-PCR for SARS-CoV-2
15773589|NCT04666194|Procedure|Cold forceps|
15773590|NCT04666194|Procedure|Cold snare|
15773591|NCT04666194|Procedure|Hot snare|
15773592|NCT04666181|Behavioral|Dual-task training|See descriptions under arm description. The dual-task training will occur across a total of 5 consecutive workday visits.
15773593|NCT04666168|Biological|Auto CAR-T|Biological: Auto CAR-T
15773594|NCT04666168|Drug|Cyclophosphamide,Fludarabine|Drug: Cyclophosphamide,Fludarabine
15773595|NCT04666168|Procedure|Leukapheresis|Leukapheresis
15773596|NCT04666155|Device|Intermittent Colonic Exoperistalsis with MOWOOT device|Patients under the experimental arm of the study should place the belt of the Mowoot device on the abdomen and use it for 20 minutes every day for 12 weeks.
15773597|NCT04666155|Combination Product|Standard of care|Patients under the active comparator arm of the study should continue with their individualized standard of care againts constipation, for 12 weeks. The standard of care uses to be different in each patient: both in drugs and doses taken (laxatives) as well as in formulation/presentation (pills, laxative syrup, suppos, etc...) and even in other help to evacuation (micro or macro enemas, digitation, etc...).
15773598|NCT04666142|Other|Comparison of the personal characteristics of the experimental and control groups|General characteristics of the individuals in the experimental and control groups were compared.
15773599|NCT04666142|Other|Light applied experimental group, control group treated with standard intensive care lighting|"According to the results of randomization, the group to which the lighting system will be applied was assigned as experiment, and the group that will continue standard ICU lighting as control"
15773600|NCT04666129|Drug|Relugolix|"(Part 1 and Part 3) Relugolix will be administered orally as a single 360-milligram (mg) loading dose of 3 x 120-mg tablets, followed by a 120-mg dose (1 x 120-mg tablets), taken once daily at approximately the same time each day.
~(Part 2) Relugolix will be administered orally as a single 360-milligram (mg) loading dose of 3 x 120-mg tablets, followed by a 240-mg dose (2 x 120-mg tablets), taken once daily at approximately the same time each day."
15773601|NCT04666129|Drug|Abiraterone|Abiraterone acetate (1000 mg [2 x 500-mg tablets]) or fine-particle abiraterone acetate (500 mg [4 x 125-mg tablets]) will be administered orally once daily.
15773602|NCT04666129|Drug|Prednisone|"(Part 1 only) For participants with mCSPC, a 5-mg dose of prednisone will be administered orally once daily, and for participants with mCRPC, a 5-mg dose of prednisone will be administered orally twice daily.
~(Part 3 only) Prednisone 5 mg can be administered orally twice daily but is not required."
15773603|NCT04666129|Drug|Methylprednisolone|For participants with mCRPC taking fine-particle abiraterone acetate, methylprednisolone 4 mg will be administered orally twice daily.
15773604|NCT04666129|Drug|Apalutamide|Apalutamide 240 mg (4 x 60-mg tablets) will be administered orally once daily.
15773605|NCT04666129|Drug|Docetaxel|Docetaxel 75 mg/m2 dose will be administered every 3 weeks as a 1-hour intravenous infusion.
15773606|NCT04666116|Dietary Supplement|Dietary supplementation in patients with covid disease admitted to hospital|Dietary supplementation in patients with covid disease admitted to hospital
15773607|NCT04666103|Procedure|Intraoperative thermal ablation|"After the thyroid lobectomy, the contralateral benign thyroid nodule was treated with intraoperative thermal ablation. The hydrodissection technique'' was used during the ablation process to prevent recurrent laryngeal nerve, esophageal and other important structures from being destroyed by heat energy."
15773608|NCT04666090|Drug|Carillizumab|administration regimen: Carillizumab 200mg, IV, D1; Albumin paclitaxel 150mg/m2, D1; Nedaplatin 50 mg/m2, D1; Apatinib 250mg Po D2-4. Preoperative neoadjuvant therapy for 2-3 cycles, one cycle every 14 days.
15773609|NCT04666090|Procedure|Esophagectomy|Laparoscopy combined with thoracoscope radical resection of esophageal carcinoma
15773610|NCT04666090|Other|Samples|Blood, Tumour and Saliva will be Collected from participant. Fate of sample is Destruction after use
15773611|NCT04666077|Behavioral|Home-based MT through Supervised, Supported Singing (H3S)|"Daily singing of song of kin. The song of kin will be derived from an assessment session and evaluation inclusive of an interview under the supervision of Dr. Joanne Loewy and her team at the Louis Armstrong Center for Music and Medicine (LACMM). The interview will include the participant and their study partner who will assist in identifying musical preferences and relevant cultural experiences. A recording of prescribed song protocols will be provided. Participants and study partners will be directed to plan a minimum of 1 hour a day in which the participant will sing along with the study partner-administered song of kin. A diary will be provided to the study partner to record the time of day, amount of time spent and comments on the activity. Study staff will contact the members of this group to confirm compliance with the activity."
15773612|NCT04666077|Behavioral|Individualized Music Therapy (IMT)|The Individualized Music therapy (IMT) conducted by the LACMM staff. It will be administered by a certified music therapist twice weekly for 45 minutes. The sessions will employ extensive clinical improvisation based on the songs of kin utilized in the H3S condition. Compliance will be measured with a weekly log which will record dates and times of each condition.
15773613|NCT04666077|Other|Attention Control (AtCon)|"The attention control (AtCon) will meet with the LACMM team for an interview in which they will be asked about music preferences and music experiences. They will answer any questions from participant and caregiver about music experiences. Study staff will contact the members of this group at the same schedule as the H3S group to assess music activity engagement. This will measure unplanned exposure and minimize drop-in music activity which could contaminate the control condition."
15773614|NCT04666064|Diagnostic Test|Covid19 RT-PCR|patients admitted to ER for suspicion of COVID-19 infection will have a SARS-CoV-2 RT-PCR test
15773615|NCT04666064|Other|lung ultrasound|patients admitted to ER for suspicion of COVID-19 infection who has a SARS-CoV-2 RT-PCR test and for whom the emergency doctor decide to perform a lung ultrasound
15773616|NCT04666051|Biological|Application of fibrin glue sealant|
15773617|NCT04666038|Drug|LOXO-305|Oral LOXO-305
15773618|NCT04666038|Drug|Idelalisib|Oral
15773619|NCT04666038|Drug|Bendamustine|IV
15773620|NCT04666038|Drug|Rituximab|IV
15773621|NCT04666025|Procedure|Biospecimen Collection|Undergo collection of nasopharyngeal swabs, blood, and saliva samples
15773622|NCT04666025|Other|Diagnostic Laboratory Biomarker Analysis|Correlative studies
15773623|NCT04666025|Other|Electronic Health Record Review|Medical charts are reviewed
15773624|NCT04666025|Other|Questionnaire Administration|Complete questionnaire
15773625|NCT04666012|Biological|AdCLD-CoV19|Replication-defective human adenovirus type 5/35 vector based vaccine expressing S protein of SARS-CoV-2.
15773626|NCT04665999|Device|Continuous Glucose Monitor|Data collection only
15773627|NCT04665986|Drug|Navelbine|Navelbine 25mg/m2 on day 1 and 8, every 3 weeks
15773628|NCT04665986|Drug|Docetaxel|Docetaxel 90mg/m2 on day 1, every 3 weeks
15773629|NCT04665973|Behavioral|Therapeutic patient education : oral semi-structured interview|The physiotherapist discusses and goes through each page of the booklet and involves the patient as much as possible. He demonstrates the exercises proposed in the booklet and then ask the patient to perform them in front of him. The physiotherapist tries to identify the patient's needs and suggests different ways to ensure that the patient has different opportunities to maintain the best possible level of PA
15773671|NCT04665661|Behavioral|Wait-list control|Women in the wait-list control group will be instructed to continue with their usual activities and manage their pain as normal (i.e., with analgesics).
15773672|NCT04665648|Drug|Nicorandil|6 mg nicorandil iv. just before coronary intervention, 6mg/h ivgtt. up to 48h after coronary intervention
15773630|NCT04665973|Behavioral|Therapeutic patient education : booklet (passive)|The booklet (11 pages): explains why it is important to maintain a good level of PA as part of cancer treatment and reviews the most common side effects of cancer therapy and the relative importance of PA in combating these effects (pages 2-3) ; defines PA, its modalities and possible security precautions (pages 4-5), suggests exercises to be performed oneself and a target intensity to be reached (pages 6-8), provides a roadmap to be completed oneself (pages 9-10), and outlines procedures for joining an exercise medicine group (page 11).
15773631|NCT04665947|Drug|[68Ga]Ga DOTA-5G and [177Lu]Lu DOTA-ABM-5G.|PET imaging using [68Ga]Ga DOTA-5G will be used to diagnose patients who are eligible for treatment with the [177Lu]Lu DOTA-ABM-5G.
15773632|NCT04665921|Drug|SGN-STNV|Given into the vein (IV; intravenously)
15773633|NCT04665908|Other|Assessment by PT/Orth surgeon|Assessment by orthopaedic surgeon or a PT
15773634|NCT04665895|Drug|Fluticasone propionate 100 mcg/blister oral inhalation powder/Respirent Pharmaceuticals|twice daily inhalation throughout the study
15773635|NCT04665895|Drug|FLOVENT DISKUS® 100 mcg/blister oral inhalation powder/GSK|twice daily inhalation throughout the study
15773636|NCT04665895|Drug|Placebo|twice daily inhalation throughout the study
15773637|NCT04665882|Procedure|Axillary surgery based on lymphedema prediction nomogram|Based on the intraoperative lymphedema prediction nomogram, individualized treatment was recommended to breast cancer patients with different level of risk. For patients with low possibility of developing breast cancer related lymphedema, it was not necessary to preserve arm lymphatics. While the breast cancer patients who were performed mastectomy and ALND with 28 kg/m2 prepared to receive taxane-based chemotherapy, supraclavicular and infraclavicular radiotherapy, according to the established intraoperative nomogram, the proportion of the arm lymph flow above the axillary vein needed to exceed 52%. Otherwise, the arm lymphatics should be identified and preserved.
15773638|NCT04665869|Behavioral|Combined balance and brisk walking training|6-months of combined balance and brisk walking training
15773639|NCT04665869|Behavioral|Flexibility and strengthening exercise|6-months of flexibility and strengthening exercise
15773640|NCT04665856|Drug|Tiragolumab|Tiragolumab at a fixed dose of 600 milligrams (mg), administered by intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
15773641|NCT04665856|Drug|Atezolizumab|Atezolizumab at a fixed dose of 1200 mg, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
15773642|NCT04665856|Drug|Carboplatin|Carboplatin administered IV to achieve an initial target area under the concentration time curve (AUC) of 5 mg/mL/min, Q3W on Day 1 of each 21-day cycle for 4 cycles.
15773643|NCT04665856|Drug|Etoposide|Etoposide 100 mg/m^2, administered by IV infusion, Q3W on Day 1, 2 and 3 of each 21-day cycle for 4 cycles.
15773644|NCT04665856|Drug|Tiragolumab Matching Placebo|Matching placebo, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
15773645|NCT04665843|Drug|Atezolizumab|Atezolizumab at a fixed dose of 1200 mg will be administered by intravenous (IV) infusion Q3W on Day 1 of each 21-day cycle.
15773646|NCT04665843|Drug|Tiragolumab|Tiragolumab at a fixed dose of 600 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
15773647|NCT04665843|Drug|Placebo|Placebo will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
15773648|NCT04665830|Drug|Evolocumab|treated patients with evolocumab for high cholesterol
15773649|NCT04665817|Diagnostic Test|CT-QFR|CT-QFR is a novel method for evaluating the functional significance of coronary stenosis. It is calculated by coronary computed tomographic angiography images.
15773650|NCT04665817|Diagnostic Test|QFR|QFR is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure drop in the vessel based on two. angiographic projections.
15773651|NCT04665817|Diagnostic Test|FFR|FFR measured by pressure wire is the gold standard for evaluating the functional significance of coronary stenosis.
15773652|NCT04665804|Dietary Supplement|Creatine Supplementation|Creatine Supplementation 20g/day for 1 week followed by 5 g/day for 3 weeks
15773653|NCT04665804|Dietary Supplement|Glucosamine and Chondroitin sulfate supplementation|Glucosamine 500 mg Chondroitin sulfate sodium 400mg 3/day
15773654|NCT04665804|Other|Supervised Exercise training|"Lower Extremity Resistance Exercise Training Treadmill walking 5-10 min for warm up Strength training: (80% of 8RM)
~3 times supervised exercise for 4 weeks leg press, leg extension, Sit to stand squat (mini squats) Stationary Cycling (Maximum Resistance as per patient tolerance till failure)
~3 sets 8 reps 10-15 s rep rest interval 1-2 min set rest interval"
15773655|NCT04665804|Other|Home Exercise Program|"2 sets of 10 repetitions/day of
~AROM isolated knee extension and knee flexion Isometric isolated knee extension and knee flexion Isometric terminal knee extension Sit to stand squat Isometric knee terminal extension"
15773656|NCT04665804|Procedure|Electrotherapy + Heating|Interferential Current therapy (2P), in combination with heating pad for 20 minutes
15773657|NCT04665804|Procedure|Joint Mobilization|Tibio-femoral Anterior Glide Tibio-femoral Posterior Glide Patellofemoral Joint Mobilization
15773658|NCT04665791|Biological|Intranasal inoculation with Neisseria lactamica|Lyophilised Neisseria lactamica will be reconstituted and administered to participants intranasally.
15773659|NCT04665778|Other|hospital bedroom booking|Patient in high risk of hospitalization group benefits a dedicated process to find and book a bedroom
15773660|NCT04665765|Drug|Carboplatin|Given IV
15773661|NCT04665765|Drug|Etoposide|Given IV
15773662|NCT04665765|Drug|Ifosfamide|Given IV
15773663|NCT04665765|Drug|Polatuzumab Vedotin|Given IV
15773664|NCT04665765|Biological|Rituximab|Given IV
15773667|NCT04665700|Drug|BI 764198|BI 764198
15773668|NCT04665700|Drug|Placebo|Placebo
15773669|NCT04665674|Other|Standard of care|Standard of car of pulmonary Langerhans cell histiocytosis (PLCH)
15773670|NCT04665661|Behavioral|High-intensity aerobic training|Women will perform treadmill-based aerobic exercise for three days a week, at 70%-85% of MHR for 30 minutes and perceived exertion of 14-16, based on the Borg RPE scale. This range39 is considered to represent HIAT. Aerobic training will be preceded by warm-up exercises for 10 minutes and followed by cool-down exercises for 10 minutes, at a perceived exertion of 11.0 (Borg RPE).
15774643|NCT04657900|Other|Observational|Observational - no intervention given
15773673|NCT04665648|Drug|Placebo|placebo iv. just before coronary intervention, ivgtt. up to 48h after coronary intervention
15773674|NCT04665635|Procedure|Rectosigmoid resection|Most of the colorectal involvements are observed in the seromuscular layer. In seromuscular infiltration, resection of the rectosigmoid colon or shaving of tumoral implants without resection can be performed.
15773675|NCT04665622|Other|Eye-Tracking / Neuropsychological evaluations|Use of Eye-Tracking / Neuropsychological évaluations in 4 groups
15773676|NCT04665609|Drug|Anlotinib and TQB2450 solution|Anlotinib is a novel multitarget tyrosine kinase inhibitor, inhibiting tumour angiogenesis and proliferative signalling. TQB2450 solution is a new novel of PD-L1 inhibitor made by Crown Bioscience and CHIATAI TIANQING(CTTQ PHARMA).
15773677|NCT04665609|Drug|TQB2450 solution|TQB2450 solution is a new novel of PD-L1 inhibitor made by Crown Bioscience and CHIATAI TIANQING(CTTQ PHARMA).
15773678|NCT04665596|Device|Ultrasound treatment|Ultrasound treatment of calcified aortic valve causing symptomatic aortic valve stenosis in patients who are not eligible for valve replacemen
15773679|NCT04665583|Other|Prehabilitation|Prehabilitation will consist of careful pre-intervention assessment and personalized optimization, guided by Investigator judgment, with a specific focus on right ventricular function. This will be done by using a detailed echo acquisition protocol (Appendix 1). Assessments will be collected according to the schedule of events below (Table 1.). Therapy will include intravenous milrinone therapy and aggressive diuresis with evaluation for clinical and functional signs of improvement, according to standard of care.
15773680|NCT04665570|Drug|BAY81-9783 (Acarbose/Metformin)|Tablet (FDC of 25/50mg acarbose + 500mg metformin), three times daily
15773682|NCT04665544|Procedure|SLN side-specific detection rate using radioactive tracer with/without blue dye and ICG tracer.|"The primary objective of this study is to compare SLN detection rate using two types of intracervical tracers (radioactive tracer with or without blue dye vs. ICG).
~The null hypothesis is that the detectionrate does not differ between the two techniques."
15773683|NCT04665531|Procedure|Erector Spinae Catheter|Patients in the experimental group will receive the Erector Spinae Catheter with an initial bolus ob 20ml 0,5% levobupivacaine prior the surgery and will be administered local anesthetics for 48 hours post-operatively.
15773684|NCT04665531|Procedure|Intercostal block|Patients in the comparative group will receive standard treatment, i.e. the multi-level intercostal block with 20ml 0,5% levobupivacaine administered at the end of the surgery by the surgeon.
15773685|NCT04665531|Drug|Ropivacaine 0.2% Injectable Solution|Patients in the experimental group will receive Ropivacaine 0,2% continous infusion of 5ml/h with boluses 15ml/4h by the Erector Spinae Catheter for 48 hours post-operatively.
15773686|NCT04665518|Other|Acupressure|Acupressure will be applied to the patients in the acupressure group for 10 min before the venipuncture procedure. Venipuncuture is applied to all patients by the same nurse in the same room. Venipuncture is performed from the left arm of all patients using a vacuum tube and a needle tip of 0.8 * 38 mm (21G x 1½, green).
15773687|NCT04665505|Behavioral|Educational Workshop|The intervention consists of providing educational content for all ICU care providers concerning building staff knowledge surrounding methods to facilitate cost-effective and evidence-based decision-making about patient care (including tests, treatments, and procedures). The first intervention is an educational workshop to increase staffs' awareness of the current Choosing Wisely Canada Critical Care strategies and recommendations to facilitate cost-effective and evidence-based decision-making about patient care (including tests, treatments, and procedures).
15773688|NCT04665505|Behavioral|Optimizing Staff Scheduling|This initiative will focus solely on the nurse subgroup and concerns schedule optimization to ensure the presence of the appropriate number of nurses per shift, thereby reducing stress, burnout and limiting the need for overtime.
15773689|NCT04665492|Diagnostic Test|EEG recording 1|"Multichannel EEG recording in eyes opened and eyes closed relaxed state and during imagined movement (all one experimental session). EEG device usbamp (company Guger Technologies, Austria) will be used."
15773690|NCT04665492|Diagnostic Test|EEG recording 2|"Multichannel EEG recording in eyes opened and eyes closed relaxed state and during imagined movement (all one experimental session). This intervention will take place six month after EEG recording 1. EEG device usbamp (company Guger Technologies, Austria) will be used."
15773691|NCT04665492|Diagnostic Test|Sensory Test|Test for mechanical sensations of the feet and shins of both legs as well as on the trapezoidal muscle on both sides. Semmes-Weinstein Monofilaments will be used
15773692|NCT04665492|Diagnostic Test|Brief Pain Inventory 1|This questionnaire that ask about any acute or chronic pain
15773693|NCT04665492|Diagnostic Test|Multidimensional health locus of control|Questionnaire that test personal belief about control of one's own health
15773694|NCT04665492|Diagnostic Test|Sensory test thermal|"Test of thermal sensations (thermal roller) of the feet and shins of both legs as well as on the trapezoidal muscle on both sides. A Somedic SenseLab Rolltemp device will be used"
15773695|NCT04665492|Diagnostic Test|Neuropathic pain symptoms|Questionnaire that test for neuropathic pain symptoms
15773696|NCT04665492|Diagnostic Test|McGill pain questionnaire|Questionnaire assess three separate components of experiencing pain; the sensory intensity, the emotional impact and the cognitive evaluation of pain.
15773697|NCT04665492|Diagnostic Test|Pain Catastrophising Scale|Questionnaire use to identify individual pain experience.
15773698|NCT04665479|Other|Web-based legacy-making intervention through digital storytelling|A child-parent dyad will participate in a nurse-delivered intervention that will guide children to create electronic digital storyboards about themselves during 6 sessions over 6 weeks.
15774644|NCT04657887|Biological|Voncento®|Solution for injection
15773699|NCT04665466|Device|Quantitative Flow Ratio derived PPG|"From coronary angiographic images, QFR will be calculated and virtual pullback curve will be abstracted and PPG index will be calculated as:
~PPG index={MaxPPG20mm/△QFRvessel+(1-length with functional disease/Total vessel length) }/2."
15773700|NCT04665453|Diagnostic Test|Electroencephalography|Recording of the brain electrical activity during sleep; background activity and sleep phases will be evaluated
15773701|NCT04665453|Diagnostic Test|Monitoring of vital functions|Measuring of respiratory rate, heart rate, SpO2, every 10 minutes after the medicine is given to the patient for the duration of EEG, and after 120 minutes. Blood pressure is measured at the time of application of the medicine, at the end of EEG and after 120 minutes.
15773702|NCT04665453|Drug|Melatonin 0,1mg/kg oral syrup|Melatonine in the form of syrup will be given orally to child.
15773703|NCT04665453|Drug|Dexmedetomidine 3 mcg/kg sublingually|Dexmedetomidine in the form of a solution will be given to child sublingually.
15773704|NCT04665453|Drug|Dexmedetomidine 3 mcg/kg intranasally|Dexmedetomidine in the form of nasal spray will be given to child intranasally.
15773705|NCT04665440|Other|Voice alone|mother's voice without tactile stimuli
15773706|NCT04665440|Other|Voice + tactile stimuli|mother's voice with tactile stimuli
15773707|NCT04665427|Other|bilioenteric anastomosis i|The creation of communication between a bile duct and a segment of the digestive tract, often to restore a flow of bile in the digestive tract,
15773708|NCT04665414|Diagnostic Test|MRI|preoperative MRI
15773709|NCT04665414|Diagnostic Test|transvaginal ultrasound|preoperative transvaginal ultrasound
15773710|NCT04665414|Diagnostic Test|transvaginal ultrasound elastography|preoperative transvaginal ultrasound elastography
15773711|NCT04665401|Behavioral|Tailored MERIT|see arm description
15773712|NCT04665401|Behavioral|Standard MERIT|see arm description
15773713|NCT04665375|Drug|DOR/3TC/TDF|switch antiretroviral regimen to doravirine/lamivudine/tenofovir disoproxil fumarate once daily for 1 year
15773714|NCT04665362|Drug|Recombinant oncolytic virus M1, anti PD-1 antibody, Apatinib|"Drug: Recombinant oncolytic virus M1
~Recombinant oncolytic virus M1 is administered intravenously 1×109 CCIC50 once daily on day1-5, every 28 day cyle.
~Other name：M1-c6v1
~Drug：Anti-PD-1 antibody
~Anti-PD-1 antibody is administered intravenously 200 mg once every 2 weeks.
~Other names：SHR-1210, Camrelizumab
~Drug: Apatinib
~Apatinib is administered orally 250mg once daily.
~Other name: Apatinib"
15773715|NCT04665349|Dietary Supplement|Nutricia Pre-op, 400 milliliters, per os|After 10 hours of fasting participants will receive per os 400 milliliters of Nutricia Pre-op
15773716|NCT04665336|Behavioral|Circadian Timing Program|"Sleep hygiene training will be provided to the participants. They will be asked to make lifestyle changes according to the Circadian Timing Program created by the researcher."
15773717|NCT04665336|Behavioral|Sleep Hygiene Training|Sleep hygiene training will be given by the researcher. There will also be sleep hygiene training sections on the website.
15773718|NCT04665310|Drug|Envarsus XR|tacrolimus, extended-release tablets, a calcineurin inhibitor
15773719|NCT04665297|Behavioral|International Guide for Monitoring Child Development|Monthly GMCD visits includes assessment of risk factors, open-ended exploration of caregiver concerns about development, assessment of functioning in seven developmental domains, and using mutual problem solving strategies to develop a nurturing care plan with the caregiver.
15773720|NCT04665284|Drug|Empagliflozin|Group A: Empagliflozin 10/25 mg once daily with or without antidiabetic drugs
15773721|NCT04665284|Drug|Usual care group|Group B: usual care group but without Empagliflozin with adjustment of therapy as the standard of care
15773722|NCT04665271|Behavioral|Zemedy App|Digital smart phone app that delivers cognitive-behavioral therapy for IBS
15773723|NCT04665232|Drug|aqueous subcutaneous progesterone|25 mg/die of aqueous subcutaneous progesterone from the day of oocytes retrieval for two weeks.
15773724|NCT04665219|Behavioral|HBM-based text messages|"The intervention in the test group will consist of a set of text messages developed based on the HBM to be sent to the parents regularly in the following 48 weeks.
~During the first 24 weeks, parents will receive a text message (and feedback if deemed appropriate) each week. In the next 24 weeks, the parents will receive a text message every 4 weeks, altogether 30 messages will be sent to the parents. All messages will be sent to the parents individually through free mobile App by a research assistant."
15773725|NCT04665219|Behavioral|Standard text message|Parents in the control group will receive an oral health education pamphlet produced by the Oral Health Education Division in the Department of Health, the Government of Hong Kong SAR. In order to maintain a double-blind design in the present study, the pamphlet will be distributed in an electronic form and sent via a text message.
15773726|NCT04665206|Drug|VT3989|25 or 100 mg capsules for oral administration.
15773727|NCT04665193|Diagnostic Test|Rapid Antigen Test|Antigen Technology Lab-based test and Point of care test
15773728|NCT04665180|Diagnostic Test|Primary knee arthroplasty|Patients who return to work after primary knee arthroplasty
15773729|NCT04665167|Behavioral|Body image exposure|Exposure therapy is a key element of evidence-based cognitive behaviour therapy for eating disorders . Body image exposure intervention involves deliberate, planned, and systematic exposure to the body image. Participants will be asked to stand so that they can see their whole body - far enough back. Participants will be asked to look at their bodies on screen. Participants will be continually encouraged by the facilitator for looking at and talking about the body parts.
15773730|NCT04665167|Behavioral|Self-compassion|The self-compassion intervention condition consists of Neff's self-compassion exercises. These exercises are part of the self-compassion intervention condition. Meditation text used in this study is obtained from the following link https://self-compassion.org/category/exercises/.
15773731|NCT04665154|Drug|MAS825|single dose i.v. and s.c.
15773732|NCT04665154|Drug|Placebo|single dose i.v. and s.c.
15773733|NCT04665141|Biological|Mepolizumab|Mepolizumab will be prescribed freely by the treating physician according to real-life conditions.
15773734|NCT04665141|Biological|Omalizumab|Omalizumab will be prescribed freely by the treating physician according to real-life conditions.
15773735|NCT04665141|Biological|Reslizumab|Reslizumab will be prescribed freely by the treating physician according to real-life conditions.
15773736|NCT04665141|Biological|Benralizumab|Benralizumab will be prescribed freely by the treating physician according to real-life conditions.
15840715|NCT04118036|Drug|Abemaciclib|Oral 2 times a day
15773737|NCT04665141|Biological|Dupilumab|Dupilumab will be prescribed freely by the treating physician according to real-life conditions.
15773738|NCT04665115|Drug|Ibrutinib|Given PO
15773739|NCT04665115|Other|Quality-of-Life Assessment|Ancillary studies
15773740|NCT04665102|Other|Image classification using deep learning algorithm|Image classification using deep learning algorithm
15773741|NCT04665089|Drug|Erythromycin|"Before each intervention (either at inclusion: day 0) and after the end of 5 days of erythromycin or placebo (day 6), the following dosages will be performed:
~Pro-inflammatory cytokine (TNF alpha)
~Anti-inflammatory cytokine (IL-10)
~Procalcitonin (PCT) Then, analysis of the variations in the TNF/ IL-10 ratio, the blood count, CRP and PCT parameters (between Day 0 and Day 6)"
15773742|NCT04665076|Biological|Auto CAR-T|Biological: Auto CAR-T
15773743|NCT04665076|Drug|Cyclophosphamide,Fludarabine|Drug: Cyclophosphamide,Fludarabine
15773744|NCT04665076|Procedure|Leukapheresis|Leukapheresis
15773745|NCT04665063|Biological|Auto CAR-T|Biological: Auto CAR-T
15773746|NCT04665063|Drug|Cyclophosphamide,Fludarabine|Drug: Cyclophosphamide,Fludarabine
15773747|NCT04665063|Procedure|Leukapheresis|Leukapheresis
15773748|NCT04665050|Biological|pPCV|pPCV vaccine 1.0 mL solution, at a dose to be determined, for intramuscular (IM) injection.
15773749|NCT04665050|Biological|PNEUMOVAX™23|PNEUMOVAX™23 0.5 mL solution, at a dose to be determined, for IM injection.
15773753|NCT04665024|Procedure|preoperative chest physiotherapy|"The patients were approached to partake in the investigation after they got full clarifications about the point of study. They were allocated into two groups and reassurance was achieved about the absence of any side effects.Furthermore, the examination was approved by the ethical committee.
~Effects of preoperative chest physiotherapy were compared between two groups, by measuring the lung functions, oxygen saturation, pulmonary complications and length of hospital staying. Lung functions were completed by utilizing spirometry parameters, oxygen saturation was measured by pulse oximeter and pulmonary complications were diagnosed by specialist doctors."
15773754|NCT04665024|Procedure|postoperative chest physiotherapy|"Postoperative chest physiotherapy made in both two groups was similar to the preoperative chest physiotherapy but this was achieved by physiotherapists and made once a day for 10-25 minutes depending on the lectures of postoperative days."
15773755|NCT04665011|Device|Indicor|A simple, non-invasive tool to report pulse response to a Valsalva maneuver
15773756|NCT04665011|Device|Caretaker|non-invasive blood pressure monitor
15773757|NCT04664998|Diagnostic Test|Diagnostic test for NG/CT|All participants will receive diagnostic testing for NG/CT at each quarterly visit.
15773758|NCT04664998|Diagnostic Test|HIV testing|All participants will receive diagnostic testing for NG/CT at each quarterly visit.
15773759|NCT04664985|Device|Mucogyne® ovule|hyaluronic acid, vaginal ovule
15773760|NCT04664972|Drug|Docetaxel +doxorubicin+ cyclophosphamide|The control group was treated with TAC (docetaxel 75 mg / m2 + adriamycin 50 mg / m2 + cyclophosphamide 500 mg / m2) for 6 cycles, 21 days was a cycle.
15773761|NCT04664972|Drug|Docetaxel +Cisplatin|The experimental group was treated with TP (docetaxel 75mg/m2 day 1 + cisplatin 25 mg/m2 day 1,2,3) neoadjuvant chemotherapy for 6 cycles, 21 days as a cycle.
15773762|NCT04664959|Drug|SB16 (Proposed Denosumab Biosimilar)|"Subjects randomised into SB16 group will receive SB16 (60 mg in 1 mL) subcutaneously every 6 months.
~At Month 12, subjects transited from Prolia® group to SB16 group will receive SB16 (60 mg in 1 mL) subcutaneously."
15773763|NCT04664959|Drug|Prolia® (Denosumab)|Subjects randomised into Prolia® group will receive Prolia® (60 mg in 1 mL) subcutaneously every 6 months.
15773764|NCT04664946|Drug|Intra-arterial administration of neuroprotective agents|Intra-arterial administration of 3-n-butylphthalide for 24 hours via microcatheter at 17.36 ug/min.
15773765|NCT04664933|Drug|Intra-arterial administration of neuroprotective agents|Intra-arterial administration of 3-n-butylphthalide for 16 to 24 hours during and after the operation at 17.36 to 26.04 ug/min
15773766|NCT04664920|Device|exergame|motor-cognitive training device
15773767|NCT04664907|Other|Videomusic listening|Patients will attend a 8 min videomusic session and questionnaires will be performed before and after this session.
15773768|NCT04664894|Drug|Sofosbuvir|the occurrence of AEs (AE) and their severity among chronic HCV patients has assessed in patinets receiving different combinations of DAAs in Pakistani Population
15773769|NCT04664881|Device|SmartHeart Device|A body-worn device that allows an individual to immediately transmit a 12-lead ECG from anywhere and anytime, using a smartphone application to a physician's office, hospital or monitoring center where designated on-call staff interpret the ECG and make recommendations.
15773770|NCT04664868|Procedure|Sphinkeeper™|Sphinkeeper™ prostheses are self-expandable solid prostheses, made of inert Hyexpan (polyacrylonitrile) and are inserted into the intersphincteric anal groove.
15773771|NCT04664855|Other|Trauma-Informed Yoga|8 weeks of twice weekly trauma-informed yoga for 45 minutes per session
15773772|NCT04664842|Other|Diaphragmatic Stretch Technique|Diaphragmatic stretch technique is an intervention intended to indirectly stretch the diaphragmatic muscle fibers. This will help to decease tension generated by trigger points, normalizing muscle ﬁber length, and improve muscle contraction.
15773773|NCT04664842|Other|Breathing Exercise Training|During diaphragmatic or abdominal breathing training, inhalation will caused diaphragm contract downwards, inflating the lungs. This filling of the lungs pushes the abdominal organs down leading to expansion of the abdomen. Subjects are required to do few repetitions during the intervention.
15773774|NCT04664829|Drug|Bexarotene|Administered orally once a day. Starting dosage: 200mg/m^2
15773775|NCT04664829|Drug|Capecitabine|Administered orally twice a day. Dosage: 1000mg/m^2
15773776|NCT04664816|Drug|n-3PUFAs Treatment|Omega-3 plus (1200 mg) orally, twice a day for at least 12 months.
15773777|NCT04664816|Drug|Placebo Treatment|Placebo orally, twice a day for at least 12 months.
15773778|NCT04664803|Drug|Cefecin Tab.|
15773779|NCT04664803|Drug|Omnicef Cap.|
15773780|NCT04664790|Device|Hyperbaric Oxygen|Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes
15773781|NCT04664790|Behavioral|Cognitive training|Neuropsychologist guided BrainHQ training
15773782|NCT04664777|Device|Masimo Model RDS7A|Masimo monitoring platform equipped with Radical-7 Pulse CO-Oximeter fingertip probe for measurement non-invazive hemoglobin level (SpHb) an perfusion index (PI)
15773783|NCT04664764|Drug|Degludec|Basal insulin comparison
15773784|NCT04664764|Drug|Glargine|Basal insulin comparison
15773785|NCT04664764|Drug|NPH insulin|Basal insulin comparison
15773786|NCT04664751|Other|Nil-per-Oral|NPO details
15773787|NCT04664738|Biological|10% PEP|PEP is comprised of platelet derived extracellular vesicles enriched in anti-inflammatory and angiogenic growth factors.
15773788|NCT04664738|Drug|TISSEEL|Fibrin sealant made from pooled human plasma
15773789|NCT04664738|Biological|20% PEP|PEP is comprised of platelet derived extracellular vesicles enriched in anti-inflammatory and angiogenic growth factors.
15773790|NCT04664725|Drug|Repaglinide, Bupropion and SHR3680|Single dose of oral administration of Repaglinide and Bupropion, Multiple dose of oral of SHR3680
15773791|NCT04664712|Dietary Supplement|Tendisulfur Pro|Dietary supplement based on Methylsulfonylmethane (2.5 g), hydrolyzed collagen (1 g), L-arginine (1 g), L-lysine (500 mg), Vitamin C (500 mg), Bromelain (200 mg), Chondroitin sulfate (150 mg), Glucosamine (150 mg) [17, 18], dry extracts of turmeric (100 mg), Boswellia (100 mg) and Myrrh (50 mg)
15773792|NCT04664712|Device|Focused shock wave|We delivered 2000 shots per session using a low/medium energy level (range between 0.01 and 0.175 milliJoule/mm2) depending on the patient's tolerance during treatment with a frequency of 4 Hz.
15773793|NCT04664699|Device|Plethymographic Variability Index|"All patients were monitored with the electrocardiogram (ECG), Non Invasive Blood Pressure (NIBP), Pulse oximetry (SpO2) and invasively with an arterial line and central venous line as per institutional protocol. In the PVI group, a pulse oximetry probe was connected to the fourth finger of the hand that did not have an arterial cannulation. The pulse oximeter was connected to a monitor The Massimo ® pulse oximeter (Massimo Corp., Irvine, CA, USA), which has a module for PVI measurements.
~PVI ≥13% indicates volume responsiveness, and PVI < 13% indicates adequate volume"
15773794|NCT04664699|Device|Standard Monitoring|All patients were monitored with the electrocardiogram (ECG), Non Invasive Blood Pressure (NIBP), Pulse oximetry (SpO2) and invasively with an arterial line and central venous line as per institutional protocol. Patients were resuscitated according to mean arterial pressure/ heart rate and urine output.
15773795|NCT04664686|Procedure|AF catheter ablation|Isolation of all four pulmonary veins and additional lesions, considered indicated by the operator
15773796|NCT04664686|Procedure|AV node ablation|AV node ablation
15773797|NCT04664673|Behavioral|Hand-Arm Bimanual Intensive Therapy Including Lower Extremities (HABIT-ILE)|motor learning-based, intensive therapy originally developed for hemiplegic children.
15773798|NCT04664673|Behavioral|Regular care|customary or usual treatment given to any adult stroke survivor
15773799|NCT04664660|Other|Retrospective analysis of obstetrics outcomes|Retrospective analysis of clinical records including general medical and gynecological history, pregnancy course, delivery mode and newborn conditions.
15773800|NCT04664621|Diagnostic Test|HepQuant|Patients undergoing TIPS procedure will receive a HepQuant test prior to and then after TIPS.
15773801|NCT04664608|Device|wearable EEG sensor|Wireless wearable EEG devices offer a new, non-invasive, and easy way of performing EEG monitoring.
15773802|NCT04664595|Drug|Propofol Fresenius|final dose of Propofol (mcg/kg) to reach the target effect-site concentration
15773803|NCT04664582|Procedure|Sentinel Lymph Node Biopsy|see intervention group description
15773804|NCT04664569|Other|observational study|observational study
15773805|NCT04664556|Other|observational study|observational study
15773806|NCT04664543|Other|Free diet|To follow the regular dietary habits with no restriction nor modification.
15773807|NCT04664543|Other|Three days low residue diet|To follow the three days before colonoscopy a diet with low content in fiber or residues.
15773808|NCT04664530|Drug|esketamine|The in-hospital intervention process is divided into a titration phase and an effect evaluation phase. After admission, all patients received pregabalin 150mg twice for one day and amitriptyline 12.5mg one piece per night. The treatment group was combined with intranasal esketamine three times per day, and individualized concentration titration was performed within 5 days. Set the initial dosage to 10mg for nasal drops. If the score is less than 5 points compared to the basic value, the dose is increased by 5 mg each time. When the dose reaches 25mg, the increment of the dose will be adjusted to 10mg. If the score is reduced by ≥5 points compared to the basic value, the current dose will be maintained and the titration will end. The titration phase will be finished when the titration dose reaches 35mg or untolerable adverse reactions occurs. Finally, a 7 tesla scan was performed on the right-hand patients with herpes on the body to explore the effect of ketamine on the brain network.
15773809|NCT04664530|Drug|Saline|The titration process in the control group with saline are the same as those in the treatment group with esketamine.
15773810|NCT04664517|Procedure|Flexible intramedullary nail (FIN)|Both bone FIN
15773811|NCT04664517|Procedure|Reduction auder general anesthesia and long arm cast|Reduction and cast
15773812|NCT04664504|Combination Product|Concurrent Chemoradiotherapy Radiotherapy|50Gy in 25 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. Concurrent chemotherapy: Capecitabine 1650 mg/m2/d.
15773813|NCT04664504|Radiation|Short-course Radiotherapy|25Gy in 5 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.
15773814|NCT04664504|Radiation|Local dose increase of Short-course Radiotherapy|25Gy in 5 fractions to the of primary tumor and to mesorectal, presacral,and internal iliac lymph nodes. And 4Gy in 1 fractions to the PGTV of primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.
15773815|NCT04664504|Drug|Consolidation chemotherapy|Intravenous infusion of oxaliplatin (130 mg/m2 over 2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 4 cycles. 4 courses*3 weeks per course.
15773816|NCT04664504|Drug|Adjuvant chemotherapy|2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 6 cycles. 6 courses*3 weeks per course
15773817|NCT04664504|Procedure|TME|Total mesorectal excision
15773818|NCT04664491|Behavioral|Standardized COPD management|"In standardized management group, patients will receive a multifaceted and integrated disease management that follows recommendations in GOLD 2020 and China Guideline on COPD care. It contains the components below.
~Maintenance therapy after initial treatment. In this study, patients' initial therapy is the prescribed inhalers at baseline. Maintenance therapy is the medications (LABA, LAMA, or ICS) prescribed for regular or long-term use after initial therapy.
~Long-term follow-up and routine monitoring of symptoms measured by CAT, mMRC and SGRQ.
~Regular pulmonary function testing for lung function monitoring
~Strengthened COPD education
~Behavioral modification, eg. encouragement of influenza/pneumococcal vaccination, providing smoking cessation counseling and pulmonary rehabilitation."
15773819|NCT04664491|Other|Routine COPD management|Patients will undergo usual care according to current clinical practice in study sites. Usual care is the routine care provided to patients. Prescription and dispense of medicine for COPD initial and maintenance therapy will be at the discretion of doctors.
15773820|NCT04664452|Other|Questionnaire|Participants will be asked to fill the questionnaire
15773821|NCT04664439|Diagnostic Test|CT-FFR|CCTA examination will be performed by qualified medical imaging technicians, and patients will be scanned with 256rows of CT, according to standard operating norms. The coronary artery physiological function evaluation software(Keya Medical Technology, Beijing, China)will be configured in the core laboratory in advance, and the relevant imaging analysts will be trained. The core laboratory will receive the CCTA inspection data and evaluate the CCTA image quality. According to the standard operation flow of the software specification, the CT-FFR analysis will be carried out on the images that meet the requirements, and the CT-FFR value of the lesions will be measured.
15773822|NCT04664400|Behavioral|Symbolic conditioning|Participants will learn associations between cues and thermal stimuli with varying temperatures (low vs. high) through symbolic conditioning (no actual heat stimuli, only pictures of thermometers)
15773823|NCT04664400|Behavioral|Conditioning|Participants will learn associations between cues and thermal stimuli with varying temperatures (low vs. high) from experience (with actual heat stimuli).
15773824|NCT04664400|Behavioral|Instructions|Participants will learn associations between cues and thermal stimuli with varying temperatures (low vs. high) from verbal instructions.
15773825|NCT04664400|Behavioral|Counterfactual|Thermal stimuli will be either the better outcome or the worse outcome out of two possible outcomes.
15773826|NCT04664387|Diagnostic Test|coronary angiography|A coronary angiography is a test to find out if there is stenosis in coronary artery.
15773827|NCT04664374|Other|MyMood|Users will use the MyMood tool. Each MyMood session consists of a brief survey, followed by a few psycho-educational 'tips'(targeted psycho-educational interventions received from time to time based on symptom severity reports as determined by the software algorithm).
15773828|NCT04664361|Dietary Supplement|Nicotinamide mononucleotide|Daily supplementation with NMN at 250 and 500 mg for 38 days in total
15773829|NCT04664361|Other|Placebo|Daily supplementation with placebo for 38 days in total
15773830|NCT04664348|Other|Posteroanterior mobilization (neutral)|"Positioning of the patient: Prone position with the lumbar area uncovered.
~Positioning of the therapist: Stand to one side of the table at the pelvis of the patient.
~Explanation of the technique: The contact will be made with the hypothenar eminence on the spinous processes to be treated. The other hand of the physiotherapist will reinforce the grip to obtain greater stability and precision. It will proceed to carry out some posteroanterior pushes of the target vertebrae, in order to desensitize the chosen area. The force exerted and the speed of the technique will be controlled by the therapist. The technique will be finished when the participant let the therapist know when the pain is gone or when the patient no longer refer a decrease on its pain.
~Both groups: The patient will be provided with a list of exercises focused on improving resistance to mechanical load in the lumbar region. The completion of the exercise will be in the 6 weeks of the duration of the treatment."
15773831|NCT04664348|Other|Posteroanterior mobilization (extension)|"Positioning of the patient: Prone position with the lumbar area uncovered. The head of the stretcher will be raised upwards, placing progressively to extend the lumbar region, until the patient communicates the reproduction of its symptoms.
~Positioning of the therapist: Stand to one side of the table at the pelvis of the patient.
~Explanation of the technique: The contact will be made with the hypothenar eminence on the spinous processes to be treated. The other hand of the physiotherapist will reinforce the grip to obtain greater stability and precision. It will proceed to carry out some posteroanterior pushes of the target vertebrae, in order to desensitize the chosen area. The force exerted and the speed of the technique will be controlled by the therapist. The technique will be finished when the participant let the therapist know when the pain is gone or when the patient no longer refer a decrease on its pain."
15773832|NCT04664335|Other|questionnaire|if no Reply to questionnaire, telephone interview
15773833|NCT04664322|Device|non invasive ventilation and high flow nasal canulae oxygen therapy|patients with hypoxemic acute respiratory failure received alternatively non invasive ventilation and high flow nasal canulae oxygen therapy
15773835|NCT04664296|Other|Review of medical patient file|Review of medical patient file, including patient tracing, brief summary of the disease course, barrier gestures, social distancing.
15773836|NCT04664296|Other|Phone call interview|less than 15 minutes phone call
15773837|NCT04664283|Device|DCB for de Novo Lesions in Large Coronary Arteries Guided by Optical Coherence Tomography|DCB for de Novo Lesions in Large Coronary Arteries Guided by both angiogram and Optical Coherence Tomography
15773838|NCT04664270|Behavioral|e-CBT|e-CBT + Mindfulness + Problem Solving
15773839|NCT04664257|Behavioral|e-CBT|e-CBT will be administered with weekly modules. See arm/group descriptions for more information.
15773840|NCT04664244|Combination Product|Combination of nimotuzumab and radiotherapy|Patients will undergo targeted radiotherapy no more than 8 weeks, and concurrent nimotuzumab 200 mg intravenous injection every one week till the ending of radiotherapy. Then patients undergo a maintaining therapy with nimotuzumab 200 mg intravenous injection every two weeks up to one year or till the disease progresses.
15773841|NCT04664218|Device|HIPEC device|To report the affordability on using the HIPEC machine of our design compared to the standard ones in poor places.
15773842|NCT04664205|Other|High Intensity Interval Exercise|One session of high intensity interval exercise
15773843|NCT04664205|Other|Moderate Intensity Continuous Exercise|One session of calorically matched moderate intensity exercise
15773844|NCT04664192|Other|Patient Biospecimen Registry (observational and blood sampling)|Clinical data collected at every blood sample collection visit.
15773845|NCT04664179|Biological|Dose Level 1A: 2 x 10^7 cells/m2|"Drug: Cyclophosphamide Patients will receive 2 daily doses of cyclophosphamide (500mg/m2/day) finishing at least 24 hours before T-cell infusion. The drug will be given intravenously (through an IV needle).
~Other Names:
~• Cytoxan
~Drug: Fludarabine Patients will receive 3 daily doses of fludarabine (30mg/m2/day) finishing at least 24 hours before T-cell infusion. The drug will be given intravenously (through an IV needle).
~Other Names:
~• Fludara"
15773846|NCT04664179|Biological|Dose Level 2A: 6 x 10^7 cells/m2|"Drug: Cyclophosphamide Patients will receive 2 daily doses of cyclophosphamide (500mg/m2/day) finishing at least 24 hours before T-cell infusion. The drug will be given intravenously (through an IV needle).
~Other Names:
~• Cytoxan
~Drug: Fludarabine Patients will receive 3 daily doses of fludarabine (30mg/m2/day) finishing at least 24 hours before T-cell infusion. The drug will be given intravenously (through an IV needle).
~Other Names:
~• Fludara"
15773847|NCT04664179|Biological|Dose Level 3A: 2 x 10^8 cells/m2|"Drug: Cyclophosphamide Patients will receive 2 daily doses of cyclophosphamide (500mg/m2/day) finishing at least 24 hours before T-cell infusion. The drug will be given intravenously (through an IV needle).
~Other Names:
~• Cytoxan
~Drug: Fludarabine Patients will receive 3 daily doses of fludarabine (30mg/m2/day) finishing at least 24 hours before T-cell infusion. The drug will be given intravenously (through an IV needle).
~Other Names:
~• Fludara"
15773848|NCT04664179|Biological|Dose Level 2B|6 x 107^ cells/m2
15773849|NCT04664179|Biological|Dose Level 3B|2 x 10^8 cells/m2
15773850|NCT04664166|Other|Alpena Otago Telehealth Program|"A physical therapist will use video visits to evaluate the participants and provide exercise instructions from Week 1 to Week 4. Each participant will use the Blue Marble Health in Motion app from a mobile tablet to complete the exercise guided by an avatar at their own pace after receiving the exercise instructions from the physical therapist. Participants are encouraged to exercise three days a week and 30 minutes each day using the app for 6 months. The exercise protocol based on the evidence-based Otago program includes warm up, strengthening, and balance exercise.
~3.5. Research Study Design and Data Analyses:"
15773851|NCT04664153|Drug|PF-07038124 ointment|PF-07038124 ointment at 0.01% with QD dosing for 6 weeks
15773852|NCT04664153|Drug|Vehicle ointment|Vehicle ointment with QD dosing for 6 weeks
15773853|NCT04664140|Other|QFR-based virtual PCI|Procedural planning of PCI based on the pullback trace given by the QFR systems in order to obtain an optimized functional result after PCI
15773854|NCT04664140|Other|angiography-based PCI|PCi according to international guidelines, local protocols and practice
15773855|NCT04664127|Drug|Kagocel+Valacyclovir|"Group 1-patients with simple severe herpes (HSV-infection orolabial and / or genital localization) treatment [Valacyclovir + Kagocel ° ] (n= 25).
~Treatment: Valacyclovir, 1000 mg orally (2 tablets of 500 mg): 1 time per day for at least 4 months continuously (the rate of suppressive therapy). * Kagocel®, 24 mg orally (2 tablets of 12 mg): 3 times per day, 5 days continuously.
~* - During the study the minimum duration of Valacyclovir suppressive therapy in instruction for medical use that drag was changed from 4 (what was using in our reserch) to 6 months, and the optimal duration of continuous antiviral therapy with PG was changed from 6 to 12 months"
15773856|NCT04664127|Drug|Valacyclovir|"Group 2 -patients with simple severe herpes (HSV-infection orolabial and/or genital localization) receiving treatment [Valacyclovir] (n= 20).
~Scheme of treatment: Valacyclovir, 1000 mg orally (2 tablets of 500 mg): 1 time per day for at least 4 months continuously (a course of suppressive therapy)*.
~* - During the study the minimum duration of Valacyclovir suppressive therapy in instruction for medical use that drag was changed from 4 (what was using in our reserch) to 6 months, and the optimal duration of continuous antiviral therapy with PG was changed from 6 to 12 months."
15773857|NCT04664114|Behavioral|Virtual Reality|Ultrasound images of the fetus in the 28th week of pregnancy of the women in the intervention group were recorded. These images were shown to the woman through virtual reality glasses during the labor. Routine practices in the hospital were made to the women in the control group. VAS (Visual Analog Scale) was applied to women in both groups when cervical dilatation was 4 and 9 cm. Approximately two hours after giving birth (to allow mothers to breastfeed their babies and to stabilize the mother's vital signs), the Women's Perception of Supportive Care at Birth Scale (POBS) and Perinatal Anxiety Screening Scale (PASS) were administered.
15773858|NCT04664101|Behavioral|REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT)|REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT) The intervention consists of high intensity interval training, consisting of a 30-minute exercise session that includes 10 x 1-minute intervals of high intensity 3x/week (e.g., Monday, Wednesday, Friday) and supplemented with 2 sessions per week of strength, balance, and mobility exercises (e.g., Tuesday, Thursday). Exercise will be supported by an activity tracker, which will allow study personnel to track patient heart rates during exercise on a daily basis, allowing them to provide individualized feedback and coaching.
15773859|NCT04664101|Other|Comparator|Patients randomized to the control arm will receive the same technology platform and education on exercise options, including HIIT, but will return home to exercise as they see fit without personalized instruction and coaching. They will be remotely monitored, but will not receive feedback unless any adverse events are noted
15773860|NCT04664088|Procedure|Acupuncture|"Patients in this group will receive acupuncture once every other day (3 days per week) over an 8-week period (a total of 24 sessions). In each session, needles will be retained for 30 minutes. The acupoints will include Baihui (DU20), Qianding (DU21), Houding (DU19), Yintang (DU29), Fengchi (GB20), Shuaigu (GB8), Tongli (HT5), Hegu (LI4), Taichong (LR3), Fenglong (ST40), Xuanzhong (GB39) and Zulinqi (GB41). The selection of acupoints is on the basis of meridian theory and patients' clinical symptoms.
~Patients are not allowed to take prophylactic medications. But in case of intolerable acute VM attacks, the patients will be instructed to take triptans as rescue medication, and the dosage of medication will be documented in the patient diary."
15773861|NCT04664088|Drug|Venlafaxine|Participants in this group will receive oral administration of venlafaxine 50 mg once a day for 8 weeks. In case of intolerable acute VM attacks, the patients will be instructed to take triptans as rescue medication, and the dosage of medication will be documented.
15773985|NCT04663113|Other|Control Group/1st group ( standard physiotherapy|It comprised of parameters such as early mobilization and ambulatory training, pulmonary physiotherapy, active and passive normal joint movement exercises.
15840915|NCT04116320|Drug|Imiquimod|Imiquimod is a TLR7 agonist therapy.
15773862|NCT04664075|Biological|Respiratory infections|With biological samples and longitudinal observations, the aim is to find and develop predictive tests to better understand how and when flu-like illness progresses to more severe disease. This may help to decide which people need to be admitted to hospital, and how their treatment needs to be increased or decreased during infection.
15773863|NCT04664062|Behavioral|Medication Assisted Treatment|All subjects will undergo MAT induction with buprenorphine. Participants will be randomized to the behavioral aspects of induction, specifically comparing office induction vs home vs synchronous telehealth induction.
15773864|NCT04664049|Dietary Supplement|NRICM101|"Direction: Take 1 sachet 2-4 times daily directly or with 400cc water before or between meals
~Indication: Externally contracted seasonal epidemic
~Function: Relieving Exterior and Facilitating Lung, clear heat of lung, Wide chest and resolve phlegm"
15773865|NCT04664036|Diagnostic Test|ultrasound|ultrasound to check for NAFLD according to Saverymuttu criteria
15773866|NCT04664036|Diagnostic Test|elastography|elastography to compare liver stiffness indices
15773867|NCT04664036|Diagnostic Test|controlled attenuation parameter (CAP)|CAP is a non-invasive additive on Fibroscan (trademark) which can quantify hepatic steatosis
15773868|NCT04664036|Diagnostic Test|FLI|the FLI is a score panel designed to screen for NAFLD
15773869|NCT04664036|Diagnostic Test|FIB-4|the FIB-4 is a score panel designed to screen for significant fibrosis
15773870|NCT04664036|Diagnostic Test|NFS|the NFS is a score panel designed to screen for significant fibrosis
15773871|NCT04664023|Procedure|Blood collection at Day 8, Day 16, Day 24, Month 6 and Month 12 after first symptoms from SARS-CoV-2 infection.|40mL blood sample will be collected at each blood collection for immunologic, enzymatic and metabolic biomarker analysis
15773872|NCT04664023|Procedure|Blood collection at 1st injection of vaccine against COVID-19, at at second injection of vaccine, at Month 1, Month 2, Month 6 and Month 12 after second injection of vaccine for volunteers|40mL blood sample will be collected at each blood collection for immunologic, enzymatic and metabolic biomarker analysis
15773873|NCT04664010|Drug|Alpha-interferon alpha, abidol, ribavirin, Buzhong Yiqi plus and minus formula, Huhuang Detoxicity Paste, Baimu Qingre Jiedu Paste, fumigation/inhalation of vitamin C|Atomized inhalation of 5 million U α-interferon and 2 mL sterilized water, twice a day; 0.2 g arbidol, three times a day, treatment course no more than 10 days; intravenous administration of ribavirin 500 mg, once every 12 hours, treatment course no more than 10 days; intravenous administration of 10 g immunoglobulin C, once a day, 3-5 days. Anti-bacterial infection treatment is given to the patients who have yellow sputum and increased levels of procalcitonin and other bacterial infection specific indicators.
15773874|NCT04664010|Drug|Alpha-interferon, abidol, ribavirin, Buzhong Yiqi plus and minus formula, Huhuang Detoxicity Paste, Baimu Qingre Jiedu Paste and 5% glucose|Buzhong Yiqi plus and minus formula: 1 dose once, twice a day, taking with warm water. Huhuang Detoxicity Paste: One dose once, twice a day, taking with warm water; Baimu Qingre Jiedu Paste: One dose once, twice a day, taking with warm water; Fumigation/inhalation of Chinese herbs and vitamin C: 30-40 minutes once, 3-7 times a day. Patients take vitamin E capsule and folic acid every day. plus invention 1
15773875|NCT04664010|Drug|Alpha-interferon, abidol, ribavirin, Buzhong Yiqi plus and minus formula, Huhuang Detoxicity Paste, Baimu Qingre Jiedu Paste and high-dose vitamin C treatment|invention 1 plus invention 2 plus 100 mL of 5% glucose containing vitamin C (10 g/60 kg body mass) is intravenously administered twice a day.
15773876|NCT04663997|Drug|177Lu-PSMA-617|IA of 7.4GBq (± 10%) IV every 6 weeks; maximum 6 cycles
15773877|NCT04663997|Drug|Docetaxel|75mg/m2 IV every 3 weeks maximum 12 cycles
15773878|NCT04663984|Behavioral|publication rates|publication rates of theses produced in the Department of Anesthesiology and reanimation
15773879|NCT04663971|Procedure|Any surgery|Any surgical procedures performed for inflammatory bowel diseases
15773880|NCT04663971|Procedure|Any medical treatment|Any treatment (including non-surgical) performed for inflammatory bowel diseases
15773881|NCT04663958|Diagnostic Test|Detection / Screening|The patients were followed up in the postoperative care unit. The presence of postoperative pulmonary complications was evaluated, and the time of discharge was recorded. On the 30th day after discharge, patients were called and checked their status in terms of mortality.
15773882|NCT04663945|Behavioral|Biobehavioral Tele-rehabilitation Sessions|Biobehavioral tele-rehabilitation sessions
15773883|NCT04663932|Procedure|immediate stenting group(one-step strategy)|Patients assigned to the immediate stenting group will undergo appropriate stent implantation based on characteristics of the lesions.
15773884|NCT04663932|Procedure|deferred stenting group (two-step strategy)|Patients assigned to the deferred stenting group will be sent back to the ward after PCI to receive standard anticoagulant and antiplatelet therapies, and the CAG will be repeated 5 to 7 days after initial intervention, followed by treatment with stent implantation.
15773885|NCT04663919|Procedure|Bariatric surgery-RYGB|"After the creation of a 15-25-cc gastric pouch from the upper stomach, transection of proximal jejunum 70 cm from Treitz ligament also called alimentary tract and anastomosis of the distal end of jejunum to the gastric pouch, and thereafter, anastomosis of the proximal end of transected jejunum to the distal part of the jejunum at 150 cm below the site of transection (jejunoileal anastomosis)."
15773886|NCT04663919|Behavioral|Dietary intervention|High-calorie medical nutrition program to ensure weight gain
15773887|NCT04663880|Other|Exposure to placebo in EEC|Patients are exposed to placebo (saline solution) in the EEC for 4h maximum
15773888|NCT04663880|Other|Exposure to three concentrations of HDM allergen in EEC|Patients are exposed to different concentrations of airborne HDM allergen (Der p1) in the EEC for 4h maximum
15773889|NCT04663880|Other|Exposure to a single concentration of HDM allergen in EEC|Patients are exposed to a single concentration of airborne HDM allergen (Der p1) in the EEC for 4h maximum
15774016|NCT04662853|Diagnostic Test|Gut microbiota determination from feces samples.|Determination of the gut microbiota composition by 16S metagenomic and building of a mathematical model, on the basis of the colonoscopies results, able to classify patients without and with color-rectal cancer-related lessions. These latter will be also classified according to the type of lession.
15773891|NCT04663854|Drug|Trehalose|Trehalose is a natural disaccharide sugar found extensively among miscellaneous organisms including bacteria, plants, insects, yeast, fungi, and invertebrates. By preventing protein denaturation, it plays various protective roles against stress conditions such as heat, freeze, oxidation, desiccation and dehydration. Owing to this capacity, trehalose is an FDA-approved pharmaceutical excipient that is used as a stabilizer in numerous medicines including parenteral products. In this study, all injections will be conducted by a trained nurse in the presence of a specialist physician at a duration of 45-90 minutes.
15773892|NCT04663841|Other|transcranial magnetic stimulation|transcranial magnetic stimulation is delivered as part of routine care and is not managed by this observational study
15773893|NCT04663828|Other|Structured counseling|Structured patient education and counselling is considered as providing information to patients in order to empower them to better manage their disorder
15773894|NCT04663828|Device|Hearing aids|Hearing aids are considered medical devices and are recommended to patients with a certain degree of hearing loss. Hearing aids amplify environmental sounds.
15773895|NCT04663828|Other|Cognitive behavioral therapy|This is a structured intervention and consists of a several week program both with noise exposure and structured interviews and expert-patient as well as patient-patient interaction in groups
15773896|NCT04663828|Other|Sound therapy|Several sounds and music are used for tinnitus disorder
15773897|NCT04663815|Behavioral|Animal-assisted activity|The intervention is an animal-assisted activity consisting of a visit to Villa Samson (a place on the campus of the hospital specifically intended for patients to meet pets), where the child will work with a therapy dog for 1 hour. Under supervision, the animal is stroked and combed by the child, they play games together, the child feeds the animal, etc.
15773898|NCT04663815|Other|Control intervention|The control intervention reenacts a normal stay in the hospital, so the child spends one hour in the hospital room where the child can play, watch tv, etc.
15773899|NCT04663802|Behavioral|RT-targeted accountable justification|This strategy will require that the RT enter an explicit rationale in the EHR if he/she enters a tidal volume value greater than 6 cc/kg into the flowsheet, similar to the physician-targeted accountable justification strategy.
15773900|NCT04663802|Behavioral|Default order set|With the default order set strategy, some mechanical ventilation order settings will be pre-populated to be consistent with LPV, including the mode and tidal volume, automatically calculated as 6 cc/kg of the patient's ideal body weight (as determined by each patient's height and gender, which are entered into the EHR on admission). The physician will have the option to opt out of any of the specified LPV settings and select other values.
15773901|NCT04663802|Behavioral|physician-targeted accountable justification|When a physician enters a mechanical ventilation order for a tidal volume that is greater than 6 cc/kg ideal body weight, an alert will appear requiring the physician to enter a reason for choosing a setting inconsistent with LPV. Clinicians will be instructed to provide a reason for deviation from LPV settings and that their response will be maintained in the medical record. The physician will not be able to sign the mechanical ventilation order set until after a response is entered.
15773902|NCT04663802|Other|Standard of Care|ICUs and clinicians will deliver standard of care to patients with no intervention
15773903|NCT04663789|Procedure|reinforcement of the staple line|The operator will perform reinforcement of the staple line with a continuous lock stitch.
15773904|NCT04663789|Procedure|staple only|The operator transect the pancreas with stapler only, without staple line reinforcement.
15773905|NCT04663763|Drug|PD-1 antibody|Sintilimab is a humanized IgG4 monoclonal antibody against the programmed death-1 (PD-1) receptor. Usage: 200mg ivgtt d1 q3w.
15773906|NCT04663763|Drug|Capecitabine|Usage: 1000mg/m2 d1-14 q3w
15773907|NCT04663763|Drug|Oxaliplatin|Usage: 130mg/m2 d1 q3w
15773908|NCT04663750|Procedure|Pars plana vitrectomy|Pars plana vitrectomy
15773909|NCT04663750|Drug|Intravitreal 2 mg aflibercept (Eylea, Bayer) will be injected at baseline then monthly for two further doses, then 2-monthly until month 12|Intravitreal 2 mg aflibercept (Eylea, Bayer) will be injected at baseline then monthly for two further doses, then 2-monthly until month 12.
15773910|NCT04663750|Drug|subretinal injection of recombinant TPA (Alteplase) up to a maximum of 25 micrograms in 0.2 mls|Subretinal injection of recombinant TPA (Alteplase, Actilyse, Boehringer Ingelheim) up to a maximum of 25 micrograms in 0.2 mls.
15773911|NCT04663750|Drug|Intravitreal 20% sulfahexafluoride (SF6) gas tamponade|Intravitreal 20% sulfahexafluoride (SF6) gas tamponade.
15773912|NCT04663737|Drug|Silmitasertib|Capsules
15773913|NCT04663737|Drug|SOC|Some therapeutics for COVID-19 are available through EUA. SOC treatment availability is expected to change during the course of this trial.
15773914|NCT04663724|Behavioral|Computer-Based Treatment|A 4-week (8 30-minute sessions) course of computer-based treatment involving viewing pictures of faces while music may play. Participants will receive research treatment twice a week.
15773915|NCT04663711|Behavioral|degree of adherence of pre-anesthetic tests at kasr Alaini hospital to the NICE-Uk guidelines|"The anesthesiologist, whom is in charge of preoperative assessment at each unit, will assess patients who are scheduled for elective surgery, and will inform senior anesthesiologists with a minimum 3 years of experience.
~preoperative investigations will be divided into: First part will be on patient's gender, ASA classification, medical history and examination.
~Second part will be on Grade of surgery - Minor/ Intermediate/ Major or complex.
~Third part is requested investigation(s), its rationale, the hierarchy of anesthesiologist requested, and the planned date for surgery.
~Fourth part is about whether that investigation(s) is adherent with NICE-UK guidelines or not."
15773916|NCT04663698|Other|Baseline|Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH
15773917|NCT04663698|Other|MESH-Resistor 5|Lung funtion testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with mesh-resistor (5hPa/L) to create laminar airflow
15773918|NCT04663698|Other|MESH-Resistor 10|Lung funtion testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with mesh-resistor (10hPa/L) to create laminar airflow
15773919|NCT04663698|Other|Perforated Resistor 7|Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with perforated resistor (inside diameter 7mm) to create a turbulent airflow
15773920|NCT04663698|Other|Perforated Resistor 11|Lung function testing with MasterScreen™ Body, CareFusion Germany GmbH, Mouthpiece with perforated resistor (inside diameter 11mm) to create a turbulent airflow
15843132|NCT04098250|Drug|Erenumab|a CGRP receptor monoclonal antibody
15773921|NCT04663685|Other|Exercise program|Participants will start with receiving two 1-on-1 exercise sessions per week. Each session is anticipated to last 30 minutes. As progress is made, participants will be encouraged to exercise independently outside the structured sessions while continuing to receive a 1-on-1 session each week. The individualized exercises are aligned with functional movements to promote personal relevance: balance, pull, squat, push, hinge, lift & carry and calf raise.
15773922|NCT04663685|Other|Nutrition education|Participants will receive a nutrition education booklet and have access to 5 online videos that correspond to key topics in the booklet, including: reading nutrition labels, types of protein, foods containing protein, incorporating protein into meals, spreading protein in meals throughout the day. Participants will attend three 60-minute nutrition seminars led by a dietitian, where the group will review content from the booklet and videos, and discuss personalized strategies for protein intake.
15773923|NCT04663672|Other|Experimental Scent|Participants will sleep in the presence of the exposure scent, delivered by an Airwick Essential Oils diffuser
15773924|NCT04663672|Other|Control Scent|Participants will sleep in the presence of a novel scent, delivered by an Airwick Essential Oils diffuser
15773925|NCT04663672|Other|No-Scent Control|Participants will sleep in the presence of an odorless control vehicle, delivered by an Airwick Essential Oils diffuser
15773926|NCT04663672|Behavioral|In-Vivo Exposure|Participants will receive 40 minutes of in-vivo exposure therapy to feared targets in the presence of a distinctive exposure scent.
15773927|NCT04663659|Other|no intervention|no intervention
15773928|NCT04663646|Other|Optokinetic stimulation|"Participants are placed in a standing position, with support products, if necessary, and virtual reality glasses will be placed where the visual stimuli will be projected.
~The study will be carried out in four different experimental conditions. These conditions will be determined by the speed of stimulation and by the voluntary or unwilling attention of the subject during the intervention. Each participant will be exposed to Slow Optokinetic Stimulation without Attention (SOKS -), Fast Optokinetic Stimulation without Attention (FOKS -), Slow Optokinetic Stimulation with Attention (SOKS +) and Fast Optokinetic Stimulation with Attention (FOKS +). The interventions will be carried out on different days with a separation between them of at least one week.
~Fast stimulations will be performed at 60º / second and slow ones at 10º / second. In the conditions with attention, the participants will be asked to detect changes that will occur in the stimulus."
15773929|NCT04663646|Other|Placebo|Participants are placed in a standing position, with support products, if necessary, and virtual reality glasses will be placed where the visual stimuli will be projected. In this group, stimulation consists of a virtual reality video projection, in which they will visualize a walk through the forest.
15773930|NCT04663633|Other|Core stability training|Functional Rhythmic Core Stability exercises performed by the experimental group. 30 minutes insert included in the Gymnasts regular training.
15773931|NCT04663620|Behavioral|Saving Babies Lives Programme|Comprehensive neonatal healthcare package
15773932|NCT04663620|Behavioral|No Saving Babies Lives Programme|No comprehensive neonatal healthcare package
15773933|NCT04663607|Behavioral|Use of PretermConnect App|Participants will receive health education via a mobile app, PretermConnect, in addition to the standard of care, and complete additional surveys on the social determinants of health
15773934|NCT04663594|Other|WofB|Online experience designed to reduce anxiety and depression and support mental health and wellbeing
15773935|NCT04663594|Other|Ashmolean Website|A generic museum website owned by the Ashmolean Museum of Art and Archaeology at the University of Oxford.
15773936|NCT04663581|Other|Left Sided Colonoscopy|Starting colonoscopy with the patient in left decubitus
15773937|NCT04663581|Other|Right Sided Colonoscopy|Starting colonoscopy with the patient in right decubitus
15773938|NCT04663568|Device|Levonorgestrel-releasing intrauterine system|Levonorgestrel-releasing intrauterine system will be inserted during the menstrual cycle
15773939|NCT04663555|Drug|Dexamethasone|Patients in the intervention group after randomization will receive dexamethasone 20 mg intravenously once daily on day 1-5, followed by dexamethasone 10 mg intravenously once daily on day 6-10. If successful extubation occurs before day 10, treatment with dexamethasone is withdrawn.
15773940|NCT04663542|Procedure|immobilization duration|brace immobilization duration after open surgery for Achilles tendon rupture
15773941|NCT04663529|Other|contact lens|daily disposable soft contact lens
15773942|NCT04663516|Other|Exergaming|games provided by the console requiring the movement of upper body, lower body and trunk.
15773943|NCT04663503|Other|Exercise program|Depending on the age, there will be two components of the exercise program completed by the patients. The first component will be strengthening exercises. The second component will be endurance activities. This will be administered by the physical therapist
15773944|NCT04663490|Diagnostic Test|Neutrophil to Lymphocyte Ratio|Zahorec et al. identified the neutrophil-lymphocyte ratio (NLR) as an inflammation marker in critical patients, defining as the absolute neutrophil count divided by the absolute lymphocyte count
15773945|NCT04663477|Diagnostic Test|patient-completed Caprini Risk Score|The participants will be asked to complete patient-completed Caprini Risk Score
15773946|NCT04663464|Combination Product|abaloparatide-sMTS|Single-dose administration of abaloparatide 300 μg applied to the thigh for 5 minutes
15773947|NCT04663464|Combination Product|abaloparatide-SC|Single-dose administration of abaloparatide 80 μg subcutaneous injection to the periumbilical region of the abdomen
15773948|NCT04663451|Radiation|radioacive iodine therapy|Hyperthyroid patients who have undergone radioactive iodine treatment to cure them from their hyperthyroidism.
15773949|NCT04663438|Drug|Chemotherapy Drugs, Cancer|Other chemotherapy:Irinotecan;topotecan;Enrotinib;Bevacil
15773986|NCT04663113|Other|2nd group- Standard physiotherapy + bicycle ergometer|"Standard physiotherapy + bicycle ergometer: In addition to the standard therapy, a bicycle ergometer for 20 minutes 5 days a week will be given.
~Patients will turn the pedals of the bicycle while sitting on the edge of the bed.
~In this protocol, a portable bicycle with adjustable pedal system, which can be placed on the edge of the bed, will be used.
~Ratings of perceived exertion (RPE) will be used to determine the intensity of aerobic activity. According to the RPE, 10-12 strength exercises will be given."
15774052|NCT04662580|Drug|ARX517|ARX517 is an ADC consisting of a humanized anti-PSMA monoclonal antibody (mAb) (IgG1κ) covalently conjugated to two (2) proprietary microtubule-disrupting toxins referred to as AS269.
15843133|NCT04098250|Other|Placebo|Placebo
15773950|NCT04663412|Other|Sentinel lymph node mapping with indocyanine green fluorescence imaging in vulvar cancer (FIGO Stage IB)|Patients diagnosed with vulvar squamous cell carcinoma (FIGO IB stage) underwent bilateral radical vulvectomy, SLN search and removal, and bilateral inguinal lymphadenectomy at the Cannizzaro Hospital Operative Unit of Obstetrics and Gynecology Department (Catania, Italy). 3 ml of indocyanine green (ICG) 0.5 mg/mL was administered in 3 peritumoral injections under general anesthesia to screen the SLN. The images were acquired using an intraoperative infrared camera system, which allowed intraoperative visualization of the SLN. An SLN was identified for each patient. The lymph nodes examined by the pathologist were negative for metastatic localization of the disease. However, patients underwent bilateral inguinofemoral lymphadenectomy, as this procedure is not currently codified as a gold standard for the detection of SLN in vulvar cancer.
15773951|NCT04663399|Other|Prospective patient|The immuno-inflammatory and thrombo-inflammatory profiles will be evaluated at inclusion, and at 24 hours +/- 12 hours of the reperfusion treatment.
15773952|NCT04663386|Drug|Budesonide-Formoterol|Dry powder inhaler
15773953|NCT04663373|Other|Step counting|Patients are given a physical activity tracker (wrist band) that they are asked to wear for two weeks after discharge from percutaneous coronary intervention.
15773954|NCT04663360|Other|Adverse Drug Reaction (ADRe) Profile|ADRe asks nurses to systematically check patients for the manifestation of itemised adverse side effects or undesirable effects of their primary care medicines, as listed in the BNF and manufacturers' Summaries of Product Characteristics (SmPCs), and seminal texts documenting known ADRs. Nurses are asked to share the identified problems with prescribers and pharmacists overseeing medicines charts.
15773955|NCT04663347|Drug|rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone|21-day cycles
15773956|NCT04663347|Drug|rituximab and lenalidomide|28-day cycles
15773957|NCT04663347|Drug|rituximab and bendamustine|28-day cycles
15773958|NCT04663347|Drug|rituximab, cytarabine, dexamethasone, and oxaliplatin/carboplatin|21-day cycles
15773959|NCT04663347|Drug|gemcitabine and oxaliplatin|28-day cycles
15773960|NCT04663347|Biological|Epcoritamab|Epcoritamab will be administered in combination with the respective standard of care chemotherapy.
15773961|NCT04663347|Biological|Epcoritamab Maintenance|Epcoritamab will be administered alone as maintenance therapy.
15773962|NCT04663334|Other|inverse myocardial remodeling|a myocardial reverse remodeling is described, generating a decrease in hypertrophy, interstitial oedema, and inflammation. Its effect on coronary microcirculatory reserve is not known. Some studies have shown improvement in coronary reserve immediately after TAVI and this effect seemed to last long after treatment
15773963|NCT04663321|Drug|MK-1942|MK-1942 (5 mg or 10 mg capsules) titrated from 5 mg to 20 mg dose BID or 10 mg BIW over 4 weeks.
15773964|NCT04663321|Drug|Placebo|Dose matched placebo capsules BID orally over 4 weeks.
15773965|NCT04663308|Drug|Volixibat|Oral capsules, administered twice daily. Volixibat is an apical sodium-dependent bile acid transporter (ASBT) inhibitor.
15773966|NCT04663308|Drug|Placebo|Capsules matched to study drug minus active substance
15773967|NCT04663295|Device|MiniMed™ 670G insulin pump system|Hybrid closed loop insulin pump with associated CGM and blood glucose meter
15773970|NCT04663269|Drug|4mg PF Dexamethasone|analgesic provided in the erector spinae block is 20mL of 0.5% Bupivicaine with 4mg of PF Dexamethasone
15773971|NCT04663269|Drug|Control Test|Peritubal block - standard local analgesic administration
15773972|NCT04663256|Other|Cognitive stimulation group|Each week for 8 weeks, GE participants attend three 60-minute sessions of cognitive exercises.
15773973|NCT04663243|Behavioral|Thinking healthy Program sessions designed for antenatal period|Low line psychosocial intervention based on the principles of Cognitive Behavior Therapy (CBT), designed for non-specialist will be applied for expectant women experiencing depression during mid to late-pregnancy. It uses the core principles and strategies of the Thinking Healthy Program (THP). Four core sessions and two booster sessions will be applied, designed for antenatal period to prevent antenatal and post partum depression.
15773974|NCT04663230|Diagnostic Test|cardiac magnetic resonance imaging|right atrial late gadolinium enhancement in % and cm2
15773975|NCT04663217|Other|Exercise|After placement of the right heart catheter patients will undergo an exercise challenge in semi-supine position until exhaustion
15773976|NCT04663204|Drug|Sparsentan|Target dose of 400 mg daily
15773977|NCT04663191|Procedure|anatomical resection|Anatomical resection with systematic lymph-node dissection
15773978|NCT04663178|Other|Warm Salt Water Foot Bath|A training booklet about chemotherapy-induced fatigue + 20-minute warm salt water application to their feet for a week after the treatment by explaining and showing the video prepared about the preparation and practice of warm salt water foot bath.
15773979|NCT04663165|Procedure|Periodontal surgery|Flap surgery at teeth with periodontal pocket depth 5 mm or more with additional bleeding or pus on probing. Elimination of dental calculus and granulation tissue as well as scaling of the root surface with scalers and ultrasonic device. Flap closure with non-resorbable sutures.
15773980|NCT04663165|Procedure|Regenerative periodontal surgery|Flap surgery at teeth with periodontal pocket depth 5 mm or more with additional bleeding or pus on probing combined with vertical bone defect of 4mm or more. After elimination of dental calculus and granulation tissue as well as scaling of the root surface with scalers and ultrasonic device, adjunctive treatment with EDTA gel applied to root surface for two minutes, followed by rinsing with saline solution. Finally, application of enamel matrix derivative on a blood free root surface, followed by flap closure with non-resorbable sutures.
15773981|NCT04663152|Behavioral|INSTACARE|CHWs will provide participants with support via phone calls, home-visits, and accompaniment to clinic visits to improve medication management and HIV viral suppression. CHWs will contact participants at least once per week for three months.
15773982|NCT04663139|Drug|Xla1|Xla1 is a Live Biotherapeutic Product (LBP) containing a strain of the bacteria Christensenella minuta (C. minuta)
15773983|NCT04663139|Drug|Placebo|Matching placebo
15773984|NCT04663126|Drug|Tc-99m tilmanocept|IV 250 µg Tilmanocept, labelled with 370 MBq of Tc-99m
15843134|NCT04098237|Drug|Pancrelipase|Pancrelipase delayed-release capsules
15773987|NCT04663113|Other|3rd group- Standard physiotherapy + exercise protocol to be developed|"Standard physiotherapy + exercise protocol to be developed: In addition to standard therapy, exercise will be given according to the measured basal metabolic rate of the patients.
~Portable indirect calorimetry will be used to measure the basal metabolic rates of the patients.
~The basal metabolic rates of the patients will be measured before the exercise and aerobic exercise or resistant exercise will be given according to the metabolic state of the patient.
~Ratings of perceived exertion (RPE) will be used as the aerobic exercise protocol and a 10-11 strength exercise will be given according to the RPE.
~If resistance exercise will be given, the intensity of the exercise (12-14) will be determined according to the RPE. Sandbags attached to the ankle will be used as a resistance exercise and 9 exercises were determined. (Knee extension, knee flexion, trunk flexion, trunk extension, hip extension, hip flexion, hip abduction, shoulder flexion, shoulder abduction"
15773988|NCT04663100|Other|Patient-reported outcome measure|Participants will complete a patient-reported outcome measure for their oral anticancer agent at two timepoints over 2 months, to assess patient symptoms and adherence to their oral anticancer agent.
15773989|NCT04663100|Other|Comprehensive Medication Review|Following the first patient-reported outcome measure, participants will be contacted by the community pharmacist for a Comprehensive Medication Review (CMR) for their chronic medications. A follow-up CMR will take place after the second patient-reported outcome measure.
15773990|NCT04663100|Other|Pharmacist communication|Throughout the study, the oncology and community pharmacists will communicate about medications through the electronic medical record.
15773991|NCT04663087|Device|XSTAT|XSTAT application will follow the manufacturer's guidance, with injection into bleeding junctional wounds. A sufficient number of sponges are used to fill the injury void. Repeated XSTAT application is performed in the event of persistent bleeding. The trial packs will contain two devices.
15773992|NCT04663087|Other|Standard of Care|As currently provided by EMS services
15773993|NCT04663074|Diagnostic Test|IVUS control|Intravascular Control of the bridging stentgrafts during branched EVAR
15773994|NCT04663061|Behavioral|Medical weight loss|Participants will be prescribed intensive medical weight loss with the goal of achieving 15% weight loss from initial weight
15773995|NCT04663061|Behavioral|Diabetes education|Participants will receive standard of care diabetes education
15773996|NCT04663061|Behavioral|Continuous glucose monitoring|Participants will use CGM devices to track blood glucose levels in near real time
15773997|NCT04663048|Procedure|PiXL|Phototherapeutic intrastromal corneal collagen cross-linking (PiXL) performed in a high-oxygen environment without corneal epithelial debridement, for treatment of low grade myopia.
15773998|NCT04663035|Drug|Tislelizumab|200mg, iv. drip, Q3W. Tislelizumab will start within 3-7 days after ablation treatment. The longest course of treatment is 12 months.
15773999|NCT04663035|Procedure|Ablation|After local anesthesia and intravenous sedative injection, the unipolar needle would be gradually inserted into the lesion and placed on the deepest edge of the lesion. The ablation electrode is a unipolar needle with a bare end of 2 or 3 cm (adjusted to tumor size). The ablation power is 150 watts (range from 100 to 200 watts). In general, the average ablation time for each lesion is about 12 minutes (ranging from 10 to 15 minutes).
15774000|NCT04663022|Other|Dunn's sensory profile questionnaire|all children will complete the Dunn Sensory Profile questionnaire
15774001|NCT04663009|Device|AutoPulse|A band circumflex of the chest that provide chest cage compressions.
15774002|NCT04662996|Biological|Blood sample|one blood sample is done before beginning a first treatment line for a metastatic castration resistant prostate cancer
15774003|NCT04662983|Device|VR-training|A musical game called Beat Saber was used to conduct training sessions. The participant's task was to cut through the blocks of various colors in his direction to the rhythm of music, using two virtual swords. The swords were controlled by the player with controllers of different colors. Blocks had to be cut with a sword whose color matches the block and in the right direction which is indicated by an arrow on the block. The training session consisted of 4 music tracks with different pace and intensity of objects. In addition, during the song, the participant had to avoid objects-objects that randomly appeared in the game scenario - forcing the whole body to move.
15774004|NCT04662970|Device|Device programming|Non-invasive electrophysiology with 65 ECG leads will be performed in 16 different device programming
15774005|NCT04662957|Dietary Supplement|Multi-strain probiotic mixture of four Bifidobacterium, five Lactobacillus and one Streptococcus species or placebo|Oral supplementation with multi-strain probiotic preparation
15774006|NCT04662957|Dietary Supplement|Maltodextrin|Maltodextrin as placebo
15774007|NCT04662944|Drug|brolucizumab|There is no treatment allocation. Patients administered Brolucizumab by prescription that have started before inclusion of the patient into the study will be enrolled.
15774008|NCT04662944|Drug|ranibizumab|There is no treatment allocation. Patients administered Ranibizumab by prescription that have started before inclusion of the patient into the study will be enrolled.
15774009|NCT04662944|Drug|aflibercept|There is no treatment allocation. Patients administered Aflibercept by prescription that have started before inclusion of the patient into the study will be enrolled.
15774011|NCT04662905|Device|Evoke Spinal Cord Stimulation (SCS) System|ECAP-controlled, closed-loop SCS
15774012|NCT04662892|Drug|Pegfilgrastim-Cbqv|Date, Dose, and cycle for subjects who received Udenyca will be recorded. Other FN prophylaxis such as Neulasta, or other pegfilgrastim biosimilars will be collected.
15774013|NCT04662879|Other|Enriching New-onset Diabetes for Pancreatic Cancer (ENDPAC) score|ENDPAC is a model to risk-stratify patients with new onset diabetes and hyperglycemia for PDAC. Score is calculated using i) age, ii) change, over past year, in body weight and iii) change, over past year, in glucose/HbA1c values obtained from the electronic medical record.
15774014|NCT04662879|Other|Abdominal imaging|Using computerized tomography (CT) scan or magnetic resonance imaging (MRI), if CT scan is contra-indicated, patients with a high ENDPAC score (>0) are approached for informed consent to participate in the imaging intervention. Imaging (CT scan) is performed at up to two time points, study baseline and approximately 3-9 months following the first imaging study.
15774015|NCT04662866|Drug|Metformin capsule 500 mg, Empagliflozin encapsulated tablet 10 mg, Pioglitazone encapsulated tablet 30 mg, Linagliptin encapsulated tablet 5 mg|Comparison of 4 different antihyperglycemic drugs
15774017|NCT04662840|Procedure|Geniculate artery embolization|Under fluoroscopic guidance and angiographic imaging, a microcatheter is used to select all the arteries feeding the affected knee and Embosphere (100-300um) particles are injected to obtaining pruning of the hypervascular tissues arteries.
15774018|NCT04662840|Procedure|Geniculate nerve ablation|Under fluoroscopic guidance, a Cool-tip RFA ablation needle is advanced such that it touches the femur at the condylar convexity on each side and the tibia at the tibial plateau convexity on the medial side. The ablation is performed to obtain an approximate zone of ablation of 2cm.
15774019|NCT04662840|Procedure|Skin infiltration of local anesthetic at groin and knee|Freezing of the skin will be performed at the groin (as prior to an arterial access for embolization procedure) and at three areas around the knee (as prior to insertion of the ablation needles for nerve ablation procedure).
15774020|NCT04662827|Dietary Supplement|Palmithylethanolamid|PEA 3x/d
15774021|NCT04662827|Other|placebo|placebo 3x/d
15774022|NCT04662814|Other|shock wave therapy|Intervention group is by shock wave therapy. A radial shock wave device (EME, ITALY) was used. for 4 sessions (one session before the expected day of period and session per day for day1 , day 2 and day 3 of each menstrual cycle) for three successive periods.
15774023|NCT04662814|Other|dietary modification|Participants will receive dietary modification for three consecutive months dietary modification will be low caffeine and high water and liquids intake and reduce the uptake of fast food, should be followed for 3 months
15774024|NCT04662801|Behavioral|Behavioral Weight Loss (BWL)|All participants will receive twelve weeks of BWL treatment.
15774025|NCT04662801|Behavioral|Early Responder: BWL continued|Participants categorized as experiencing early weight loss at the end of the first month of treatment will continue with BWL for the remainder of treatment.
15774026|NCT04662801|Combination Product|Early Non-responder: BWL continued with medication added|Participants categorized as not experiencing early weight loss at the end of the first month of treatment will continue BWL plus a weight loss medication (Naltrexone Bupropion) for the remainder of treatment.
15774027|NCT04662788|Drug|NK cells/Combined Monoclonal Antibodies|Each subject receive NK cells/Combined Monoclonal Antibodies
15774028|NCT04662775|Behavioral|HERizon Project|"1. Participants were asked to complete 3x30-minute physical activity sessions each week & record their sessions using a logbook. They were given the choice of different types of home-based virtual exercise. 2. Behaviour change support calls - participants were allocated an Activity Mentor (trainee sport and exercise psychologists, was supervised by a HCPC-registered Psychologist). Participants had seven weekly videocalls. Each call was based on a pre-planned session outline and was goal orientated, participant centred and focused on physical activity. 3. No reply SMS - Participants received 3 standardised text messages each week, aimed at providing physical activity -related facts, encouragement and study information."
15774029|NCT04662762|Other|Nursing intervention programme|educational information
15774030|NCT04662736|Other|patients having had a BJI/PJI treated with tedizolid as a suppressive antibiotic therapy|description of osteo-articular infection managed with tedizolid as a suppressive antibiotic therapy
15774031|NCT04662723|Drug|Corticosteroid|To reduce the progression of renal damage in IgAN Patients
15774032|NCT04662723|Drug|Renin-angiotensin sytem blockers|To reduce the progression of renal damage in IgAN Patients
15774033|NCT04662723|Drug|Sodium-glucose cotransporter 2 inhibitor|To reduce the progression of renal damage in IgAN Patients
15774040|NCT04662684|Drug|Rivaroxaban 10 MG|No intervention
15774041|NCT04662671|Device|RD-X19|Experimental device that uses safe electromagnetic energy to stimulate the proximal repository of respiratory tract infectious disease pathogens.
15774042|NCT04662658|Drug|Hyperpolarized Xenon -129 MRI|e-cigarette sub-study
15774043|NCT04662645|Other|Palliative Therapy|Undergo embedded palliative care
15774044|NCT04662645|Other|Questionnaire Administration|Ancillary studies
15774048|NCT04662619|Other|B. infantis|"Bifidobacterium longum subspecies infantis strain EVC001, designated a Foods for Special Dietary Use (FSDU), will be provided to infants once daily for 12 weeks."
15774049|NCT04662619|Other|Lactose Placebo|Powdered infant formula grade lactose will be provided to infants once daily for 12 weeks.
15774050|NCT04662606|Behavioral|Consumption of a standard meal prior to the fMRI data collection|Consumption of a standard meal prior to the fMRI data collection
15774051|NCT04662593|Behavioral|Whole Health Program|A mind-body-spirit intervention to improve health and well-being including weight loss.
15774053|NCT04662567|Drug|acetaminophen|compare the postoperative pain 1 hour and ~24h post surgery
15774054|NCT04662554|Device|1-mm Resolution Clinical PET camera|1-Millimeter Resolution Clinical PET System in Head and Neck Cancer (HNC) Imaging
15774055|NCT04662541|Other|Mobile Integrated Health (MIH)|MIH leverages paramedics in the community and telemedicine (technology-enabled communication for health purposes) to provide medical care to heart failure patients in the home.
15774056|NCT04662541|Other|Transitions of care coordinator (TOCC)|The TOCC group will receive a follow-up phone call shortly after discharge in which the patient is assessed and connected to clinical and social services as needed and patient education is reinforced.
15774057|NCT04662528|Drug|Placebo|4 x 1g capsules/day
15774058|NCT04662528|Drug|MAT9001 (omega-3 pentaenoic acid)|4 x 1g capsules/day
15774059|NCT04662515|Procedure|Type of surgery|surgical or non-surgical extraction one or more teeth
15774060|NCT04662515|Drug|Dabigatran|
15774061|NCT04662515|Drug|Rivaroxaban|
15774062|NCT04662515|Drug|Apixaban|
15774063|NCT04662515|Drug|Edoxaban|
15774064|NCT04662515|Drug|Warfarin|
15774065|NCT04662502|Dietary Supplement|Bifidobacterium longum 35624|Bifidobacterium longum 35624, 1 x 10^9 CFU/capsule, 1 capsule/day over 1 month
15774066|NCT04662489|Procedure|Pulmonary vein electrical isolation|Electrical isolation of the pulmonary veins from the left atrium with cryoablation therapy
15774067|NCT04662489|Procedure|Radial ablation|Electrical isolation of the pulmonary veins from the left atrium plus radial ablation of rotational activity sites with radiofrequency ablation.
15774068|NCT04662476|Dietary Supplement|Vitamin D3|Vitamin D3 supplement
15774069|NCT04662463|Behavioral|Cognitive Bias Modification for Interpretation (CBM-I)|Patients will receive CBM-I training by reading and imaging themselves in a series of emotionally ambiguous scenarios. Each scenario ends with an incomplete final word. Patients need to complete the final word to resolve the scenario in a positive direction.
15774070|NCT04662463|Behavioral|Placebo|Patients will receive placebo task which uses neutral rather than emotional material.
15774071|NCT04662450|Behavioral|ABM affective pain stimuli|Patients undergo ABM training to shift attention away from affective pain stimuli
15774072|NCT04662450|Behavioral|ABM sensory pain stimuli|Patients undergo ABM training to shift attention away from sensory pain stimuli
15774073|NCT04662450|Behavioral|Placebo|Patients undergo ABM training to receive affective/neutral and sensory/neutral word pairs
15774074|NCT04662437|Diagnostic Test|Venous blood was collected for biochemistry testing|From the people in the healthy control group, 10 ml of venous blood was collected from the venous vein in the forearm of all individuals in the study. Parathyroid hormone, calcium, phosphorus, alkaline phosphatase levels were measured from this blood.
15774075|NCT04662424|Other|music in labor|Women in the intervention group will be offered music in labor, defined listening to music from the randomization until the delivery of the baby. Women had the possibility to select the songs at their discretion
15774076|NCT04662411|Dietary Supplement|Placebo|acute intake of 0 mg butyrate and hexanoate
15774077|NCT04662411|Dietary Supplement|butyrate and hexanoate amount 1|acute intake of 650 mg butyrate and hexanoate
15774078|NCT04662411|Dietary Supplement|butyrate and hexanoate amount 2|acute intake of 1325 mg butyrate and hexanoate
15774079|NCT04662411|Dietary Supplement|butyrate and hexanoate amount 3|acute intake of 2000 mg butyrate and hexanoate
15774080|NCT04662398|Device|JT Device|Shocker giving electrical shocks on testes
15774081|NCT04662385|Drug|aloe vera toothpaste|aloe vera toothpaste have antimicrobial and other multipotential effects.
15774082|NCT04662385|Drug|Colgate Total|Whitening toothpaste that removes and prevents new stains Fights bacteria on teeth, tongue, cheeks and gums for whole mouth healthy Mint toothpaste for long lasting fresh breath Helps prevent plaque, tartar, cavities & gingivitis
15774083|NCT04662372|Other|Description|description of the cognitive and behavioral profile of stroke mimics patients, without evidence of neurological disease.
15774084|NCT04662359|Diagnostic Test|Ultrasound Assessment|Patients will undergo an ultrasound scan to assess the severity of their rheumatoid arthritis.
15774085|NCT04662346|Other|Difficulty score system for robotic pancreatoduodenectomy|calculate the score for patient in you cohort
15774086|NCT04662333|Procedure|Transcrestal approach for sinus lift|After surgical exposure of maxillary alveolar crest, implant site preparation and transcrestal detachment of Schneiderian's membrane will be performed. Thereafter implant will be placed, protruding in the maxillary sinus with its apical part.
15774087|NCT04662333|Procedure|Xenograft application|Before implant placement, xenogenic collagen membrane and bone granules will be pushed under the Schneiderian's membrane through the surgical site.
15774088|NCT04662320|Device|Checkpoint BEST System|"Single use medical device, consisting of electric stimulator and intraoperative lead. Therapy consists of single, 10 minute dose delivered proximal to site of decompression/repair.
~Other Name: Checkpoint BEST System"
15774089|NCT04662307|Device|Intelligent cardiopulmonary rehabilitation system (ICRS)|Participants are required to wear a wristband heart rate monitor and exercise on a cycling ergometer-based ICRS for 30 minutes (5 minute of warm-up, 20 minutes of training followed by 5 minutes of cooldown). The target intensity for the 20-min training period is set at 60%~80% HRR determined in the pretest of cardiopulmonary exercise test.
15774090|NCT04662294|Drug|CD70 CAR T-cells|Each subject receive CD70 CAR T-cells by intravenous infusion
15774091|NCT04662281|Drug|LX9211|11-week assessment period
15774092|NCT04662281|Drug|Placebo|11-week assessment period
15774093|NCT04662255|Drug|LOXO-305|Oral LOXO-305
15774094|NCT04662255|Drug|Ibrutinib|Oral
15774095|NCT04662255|Drug|Acalabrutinib|Oral
15774096|NCT04662255|Drug|Zanubrutinib|Oral
15774097|NCT04662242|Drug|Selenium Supplement|Zelnite 400mcg/day in normal saline 100ml iv infusion for 7 days
15774098|NCT04662242|Drug|normal saline|normal saline 100ml iv infusion for 7 days
15774099|NCT04662229|Device|Eco-guided Percutaneous Electrical Stimulation|Pointer 10 hz. A symetric, biphasic current of 10 hz and 240 microsecond. The stimulation intensity will be reaching the excitomotor threshold, producing visible but comfortable contractions.
15774100|NCT04662229|Device|Sham stimulation|Application of the needles only on the median and ulnar nerve of the arm, for 1 minute on each nerve without current intensity and applying a son.
15774131|NCT04661982|Other|Quality-of-Life Assessment|Ancillary studies
15774101|NCT04662216|Procedure|Scaling and root planing|Scaling and root planing will be accomplished with ultrasonic and hand instruments (Gracey curettes).
15774102|NCT04662216|Procedure|"Scaling and root planing + Perisolv +Hyadent BG gels"|"Scaling and root planing will be accomplished with ultrasonic and hand instruments (Gracey curettes), Perisolv gel will adjectively be applied to all pockets with probing depth(PD) ≥ 5 mm, which will be inserted into periodontal pockets before and during SRP (2 times). The nozzle will be placed in the pocket mesially, lingually, distally and bucally. Afterwards, all teeth will be polished and all treated pockets will be filled with hyaluronic acid gel (Hyadent BG)."
15774103|NCT04662190|Device|3D printing model/guide.|Orbital decompression surgery will be previously planned and simulated using 3D-printed individualized models. In the operating room, surgery will be assisted with 3D-printed individualized guides.
15774104|NCT04662190|Procedure|Standard surgery|Orbital decompression surgery will be previously planned and simulated using the actual standard methods.
15774105|NCT04662177|Drug|Dexmedetomidine|The study participants are divided into two groups: Group 1 starts with a bolus of dexmedetomidine 0.4 µg/kg over 10 minutes, followed by con-tinuous infusion of dexmedetomidine 0.4 µg/kg/h until the end of burst suppression. Group 2 receives the standard anaesthesia management.
15774106|NCT04662164|Drug|hepalatide|3 different dosage will be given sequentially to T2D patients
15774107|NCT04662151|Biological|AT-100|reconstituted AT-100 for intratracheal administration
15774108|NCT04662151|Procedure|Air-sham|room air for intratracheal administration
15774109|NCT04662138|Drug|directly acting antivirals|Different regimens given for genotype 4 relapse: Sofosbuvir/velpatasvir/voxilaprevir ±ribavirin; sofosbuvir/velpatasvir ±ribavirin; ombitasvir/paritaprevir/ritonavir+ ribavirin
15774110|NCT04662125|Drug|Oral prednisolone|Patients will receive three tablets per day (one oral tablet prednisolone 20 mg plus two tablets of vitamins to maintain blinding) for three days.
15774111|NCT04662125|Drug|oral Pregabalin|Patients will receive three tablets per day (oral tablet pregabalin 100 mg) for three days.
15774112|NCT04662125|Drug|caffeine, paracetamol tablet|Patients will receive good hydration, recumbent positioning, three tablets per day (combined paracetamol and caffeine tablet) for three days and stool softener.
15774113|NCT04662112|Drug|NASOX|Oxalipatin 60 mg/m2 IV (2 h infusion) on Day 1, every 2 weeks Nal-IRI 50-60 mg/m2 IV (FBE, 90 min infusion) on Day 1, every 2 weeks S-1 40mg/m2 oral twice daily on Day 1-7, every 2 weeks
15774114|NCT04662099|Biological|Conditioning chemotherapy followed by CAR T cell infusion|Conditioning chemotherapy: Cyclophosphamide 250 mg/m^2 and fludarabine 30 mg/m^2 IV infusion on days -5, -4, and -3 CAR T cells infusion: 0.75x10^6-6.0X10^6 CAR+ T cells per kg of recipient bodyweight. if DLTs don't occur at the dose of 6.0X10^6 CAR+ T cells per kg, the investigators will discuss whether to try higher dose.
15774115|NCT04662086|Drug|Acebilustat|100 mg capsule administered orally once daily
15774116|NCT04662086|Drug|Camostat|200 mg (2 x 100 mg tablet) administered orally four times daily (800 mg total daily dose).
15774117|NCT04662073|Drug|Camostat|200 mg (2 x 100 mg tablet) administered orally four times daily (800 mg total daily dose).
15774118|NCT04662073|Drug|Placebo|Placebo to match camostat administered orally four times daily
15774119|NCT04662060|Drug|Acebilustat|100 mg capsule administered orally once daily
15774120|NCT04662060|Drug|Placebo|Placebo to match acebilustat administered orally once daily
15774121|NCT04662034|Device|CMIC|The C-MIC System consists of three implantable parts: a transvenous and an epicardial lead which are both connected to an implanted power source, and an external programing device. The patch lead is placed over the free wall of the left ventricle and fixated with sutures. When lead placement is achieved, the leads are then tunneled subcutaneously to the infraclavicular region and connected to the power source.
15774122|NCT04662034|Drug|Standard of Care (SOC)|Patients receive optimal SOC based defined in pertinent guideline and at the discretion of the investigator
15774123|NCT04662021|Other|Aerobic Exercises|Participants perform one hour of regular moderate to vigorous physical activities about (70 % to 90 %) of the maximum heart rate which was calculated according to this formula (HR max= 220- age)
15774124|NCT04662008|Behavioral|Tele-coaching|This intervention arm will receive 4 one-to-one tele-coaching sessions facilitated by an advanced practice social worker. The sessions will take place over a 6-week period and will begin with a needs assessments to allow for tailoring of the intervention sessions. The sessions will include information and support in the areas of: general MS information, strategies for caring for a loved one with MS, MS and Covid (care strategies), caring for yourself, and planning for the future. The intervention will take place using Zoom videoconferencing technology or via telephone- per subject preference. In addition, all subjects will receive access to a study-specific website. The website will have links to publicly available information including general information about MS, online information, self-care, communication, caregiving, COVID-19, future planning.
15774125|NCT04662008|Behavioral|Website|This intervention arm will receive access to a study-specific website. The website will have links to publicly available information including: general information about MS, online information, self-care, communication, caregiving, COVID-19, future planning.
15774126|NCT04661995|Combination Product|Hearing Aid and Notched Noise Therapy|Notched Noise Therapy involves presenting wide-band sound with the tinnitus frequency region notched out, referred to as notched noise, or notch therapy. This procedure may distribute lateral inhibition into the notched frequency region, suppressing tinnitus neural activity believed to be occurring there. This type of therapy is provided through a sound file that is streamed through hearing aids.
15774127|NCT04661995|Combination Product|Hearing Aid and Broadband Noise|"Broadband Noise, or white noise, is a common tinnitus sound therapy treatment option. It is also commonly used as a masker noise for individuals with tinnitus that like to enrich their environment with sound."
15774128|NCT04661995|Device|Hearing Aid|A-O groups will use ear-level, self-contained devices (hearing aids) that (1) are capable of streaming shapeable broadband noise between 1-10 kHz; (2) allow for normal conversation; and (3) are comfortable, easy to use, and discrete. These criteria describe a behind-the-ear hearing aid with the capability of streaming custom sounds. Hearing aids are used to provide amplification to those with hearing loss and are fit by licensed audiologists. Sometimes, hearing aids can provide benefit to those with bothersome tinnitus.
15774129|NCT04661982|Other|Long-term Follow-up|Undergo long term follow-up
15774130|NCT04661982|Other|Questionnaire Administration|Ancillary studies
15774132|NCT04661969|Procedure|Surgery|(group 1) In-bloc excision and primary closure (group 2), Resection plus Vacuum assisted closure (VAC) and split thickness skin graft (STSG) (group 3) and In-bloc excision and microsurgical reconstruction (group 4).
15774133|NCT04661956|Procedure|Transbronchial cryobiopsy/Transbronchial lung biopsy (forcep)|Transbronchial lung biopsy by cryoprobe or by forcep
15774134|NCT04661943|Drug|Tucidinostat|Tucidinostat Specification: 5mg / tablet. Dosage: oral, 20 mg (3 tablets) each time, twice a week, with the interval of no less than 3 days (such as Monday and Thursday, Tuesday, Friday, Wednesday and Saturday, etc.)
15774135|NCT04661930|Drug|TriCor® 145mg tablets|Fenofibrate; 145 mg daily (1/day); oral administration; 10 days
15774136|NCT04661930|Other|Usual Care|All participants will otherwise receive usual medical care
15774137|NCT04661930|Other|Placebo|Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration
15774138|NCT04661917|Drug|BAY2327949|60 mg of BAY2327949 (2 tablets of 30 mg, orally) once daily for 28 days.
15774139|NCT04661917|Drug|Placebo|Matching placebo orally once daily for 28 days.
15774140|NCT04661904|Device|Continuous theta burst stimulation (cTBS)|Our active treatment will consist of 600 pulses per session, delivered over the right dorsolateral prefrontal cortex at 80% of resting motor threshold (RMT). Every session cTBS consists of 50 Hz triplets of pulses delivered at 5 Hz for 40 seconds for a total of 600 pulses. Every set simulation includes 3 sessions. All enrolled patient in the cTBS group will receive 1 set simulation per day with an intersession interval (ISI) of over 30 minutes during the hospitalization after the surgery. The first set of stimulation will be given at 4 hours after the end of surgery on the day of surgery. The other sets of stimulation will be given at 8 am, 8:30 am and 9:00 am on postoperative day 1,2 and 3, respectively.
15774141|NCT04661904|Device|Sham stimulation|The sham stimulation group will receive a sham cTBS (600 pulses per session, 3 sessions per day, ISI ≥ 30mins, 4 days) with the coil set at 90 against the skull. The first set of stimulation will be given at 4 hours after the end of surgery on the day of surgery. The other sets of stimulation will be given at 8 am, 8:30 am and 9:00 am on postoperative day 1,2 and 3, respectively.
15774142|NCT04661891|Other|Isometric contractions|HD-EMG grids will be applied to the lower limb muscles of interest. Isometric contractions will consist of applying joint torque to reach a pre-defined torque level based on the subject's maximal voluntary contraction (i.e., 25%, 60%, 70%, 80%, 90%). The participant will control torque intensity by responding to a biofeedback displayed on a screen. The joint will be secured with non-compliant bands to prevent any movement of the participant. The order of the joints tested (i.e., dominant ankle, knee, or hip joint) will be randomized.
15774143|NCT04661891|Other|Isokinetic contractions|HD-EMG grids will be applied to the lower limb muscles of interest. Isometric contractions will consist of moving a joint to completing a set of contractions (10-20 contractions) at various velocities (i.e., 10 degrees per second, 30 degrees per second, 60 degrees per second). The joint will be secured with non-compliant bands to prevent any movement of the participant. The order of the joints tested (i.e., dominant ankle, knee, or hip joint) will be randomized.
15774144|NCT04661891|Device|Dynamic contractions|HD-EMG grids will be applied to the lower limb muscles of interest. Multi-joint tasks (i.e. walking, squatting, cycling) will be performed at a given frequency. A motion capture system will be used to record the joint angles and ground reaction forces simultaneously.
15774145|NCT04661891|Device|Isometric contraction with muscle fatigue|"An identical experiment will be performed as stated in Isometric contraction with the addition of induced muscle fatigue by repeatedly maintaining 40% of muscle torque until failure to maintain a contraction for 5 seconds."
15774146|NCT04661891|Device|Multi-joint functional activities while wearing exoskeleton|Participants will be measured and fitted with the bilateral exoskeleton, and sufficient range of motion to used exoskeleton will be confirmed. HD-EMG grids will be applied to the lower limb muscles of interest. The participant will perform single-joint movements to calibrate the decoder parameters. The participant will then perform multi-joint activities (e.g., standing, squatting, walking overground or on a treadmill, cycling, or stair climbing) in a movement analysis laboratory.
15774147|NCT04661878|Behavioral|Social Support|The app will provide opportunities for participants to interact with each other as well as trained peer mentors to receive and provide social support.
15774148|NCT04661878|Behavioral|Informational Resources|The app will provide opportunities for participants to review HIV-related health information in engaging formats (e.g., activities, multi-media resources, and answer to users' health questions)
15774149|NCT04661878|Behavioral|Self-Monitoring and habit formation|The app will provide opportunities for participants to track their treatment adherence and schedule tailored reminders.
15774150|NCT04661878|Behavioral|Goal setting and action planning|The app will provide opportunities for participants to identify goals, select action items, and receive tailored feedback on the action plan.
15774151|NCT04661865|Other|Health Information Package Program (HIP program )|"Fifteen minutes PowerPoint presentation will be introduced to women to increase women's educational experience and raise their level of engagement and commitment.
~The principal investigator will narrate the video record with PowerPoint slides and it was recorded as a video and will include information regarding the introduction to pregnancy, causes and predisposing factors of iron deficiency anemia during pregnancy, signs and symptoms, prevention, management of iron deficiency anemia during pregnancy that includes iron therapy, iron supplementation, dietary management. Content validity for the information in the video will be done by sending it to three experts in maternity nursing. Iron supplementation will be given to all participants who will start by sixteen weeks of pregnancy and they will receive information regarding the proper usage of iron supplements."
15774152|NCT04661852|Drug|Cabozantinib|PO (dose and schedule based upon dose level and nomogram)
15774153|NCT04661852|Drug|Topotecan|IV, over 30 minutes (schedule based upon dose level)
15774154|NCT04661852|Drug|Cyclophosphamide|IV, over 30 minutes (schedule based upon dose level)
15774155|NCT04661852|Drug|Myeloid growth factor|subcutaneous filgrastim (daily until ANC ≥ 1,500/mm3 after nadir) or pegfilgrastim (once) must be given, with choice of agent per institutional standard or treating physician preference, starting on day 5, 6, 7 or 8 (depending upon chemotherapy timing)
15774156|NCT04661839|Biological|COVID-HIGIV|COVID-HIGIV is a purified immunoglobulin G (IgG) liquid preparation containing antibodies (including neutralizing antibodies) to SARS-CoV-2. COVID-HIGIV will be administered via intravenous infusion.
15774645|NCT04657874|Other|Bromelains and Escin Oral Tablet|Supportive care after oral surgery
15774157|NCT04661839|Other|Placebo (saline)|The reference product is a liquid solution of normal saline (0.9% weight per unit volume (w/v) sodium chloride). Placebo will be administered via intravenous infusion.
15774158|NCT04661826|Drug|Oncofid-P-B|Paclitaxel - Hyaluronic Acid 600 mg - Solution for intravesical administration.
15774159|NCT04661813|Other|EXTRA-CVD Virtual Care|"The original EXTRA-CVD intervention was developed to improve blood pressure and cholesterol control among People Living with HIV. The intervention will be adapted to the post-COVID healthcare delivery landscape as a virtual intervention delivered by phone, teleconference, internet support groups, and nurse care coordination."
15774160|NCT04661800|Other|Sniffin's stick test|The sniffin's stick test is a three-part test consisting of smelling odor pens: 1) determining a detection threshold, 2) discriminating ability, 3) ability to identify odors. It lasts about 30 minutes, is achievable in the room.
15774161|NCT04661774|Other|reflexology massage|reflexology massage of the foot zone implicated in diaphragm stimulation
15774162|NCT04661774|Other|sham massage|traditional massage of the foot
15774163|NCT04661761|Diagnostic Test|Paraffin Pellets from Aurosan GmbH|1 to 2 minutes pre-chewing time chewing Paraffin Pellets from Aurosan GmbH, after which the amount of saliva is collected over a period of five minutes. The patient may chew the chewing gum once per second; after each minute the produced amount of saliva is spit in a cup, the whole amount measured after 5 minutes.
15774164|NCT04661761|Diagnostic Test|Chewing wax from the Saliva-Check Buffer from GC Europe|1 to 2 minutes pre-chewing time chewing wax from the Saliva-Check Buffer from GC Europe, after which the amount of saliva is collected over a period of five minutes. The patient may chew the chewing gum once per second; after each minute the produced amount of saliva is spit in a cup, the whole amount measured after 5 minutes.
15774165|NCT04661748|Device|real time alarm of deviating vital signs|Intervention consists of actively alerting staff personnel if physiologic vital signs, deviates from certain thresholds
15774166|NCT04661722|Other|No intervention|No intervention
15774167|NCT04661709|Drug|Wen Xin granule|one dose daily, two times per day.
15774168|NCT04661709|Drug|Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet|one tablet daily. (for patients who can't use aspirin)
15774169|NCT04661709|Drug|Atorvastatin Calcium|20 mg tablet, one tablet each night.
15774170|NCT04661709|Drug|Isosorbide Mononitrate Tab 20 MG|one tablet， twice daily.
15774171|NCT04661709|Drug|Metoprolol Tartrate Tab 25 MG|12.5 mg or 25 mg, two times daily.
15774172|NCT04661709|Drug|Aspirin Enteric-coated Tablets|100mg tablet, one tablet daily.
15774173|NCT04661709|Drug|WXG placebo|one dose daily, two times per day.
15774174|NCT04661709|Drug|Trimetazidine Dihydrochloride Tablets|20 mg tablet, one tablet three times daily.
15774175|NCT04661709|Drug|glyceryl trinitrate|be taken when angina pectoris attacks.
15774176|NCT04661696|Drug|Paclitaxel (albumin-bound)|The dose of intravenous chemotherapy drug is calculated according to the body surface area.When patients have serious adverse events, dose suspension and dose reduction are allowed. Paclitaxel (albumin-bound) was allowed to be reduced only twice (20% standard dose reduction in the first dose and 20% lower in the second dose).Once the dose is reduced, all subsequent doses should be maintained at reduced dosage.
15774177|NCT04661683|Other|e-hookah aerosol|Exposure to secondhand aerosol delivered by an e-hookah vaping machine for 30 mins
15774178|NCT04661683|Other|clean air|Exposure to clean air for 30 mins.
15774179|NCT04661670|Device|occlusal stabilization splints|an intraoral appliance that has flat surface to allow bilateral posterior contacts in coincidence with physiologic condylar seating and to produce smooth anterior guidance in excursions
15774180|NCT04661657|Other|Transthoracic echocardiogram (TTE)|Subjects will undergo TTE imaging.
15774181|NCT04661657|Other|Cardiovascular Magnetic Resonance (CMR) Imaging|Subjects will undergo CMR Imaging using a gadolinium based contrast agent (GBCA).
15774182|NCT04661644|Biological|Clusters of adipose-derived mesenchymal stem cells (Dose: 1 x 10^7 cells/1 mL/vial)|Dose: 1 x 10^7 cells/1 mL/vial (1,000 clusters of adipose-derived mesenchymal stem cells)
15774183|NCT04661644|Biological|Clusters of adipose-derived mesenchymal stem cells (Dose: 1 x 10^8 cells/1 mL/vial)|Dose: 1 x 10^8 cells/1 mL/vial (10,000 clusters of adipose-derived mesenchymal stem cells)
15774184|NCT04661631|Diagnostic Test|Lung ultrasound|Lung ultrasound during the screening process for SARS-CoV-2 infection in patients with an indication for urgent surgery.
15774185|NCT04661618|Device|Gym Tonic programme and Gym equipment|12 week progressive training - Strength exercises on 6 pneumatic gym equipment following Gym Tonic's protocol twice a week 12 weeks maintenance training - Strength exercises on 6 pneumatic gym equipment following Gym Tonic's protocol once a week
15774186|NCT04661605|Diagnostic Test|Recurrent Neural Network|We will propose a similar Moiré feature analyzing approach based on Recurrent Neural Network to process the measured Slip Pulse wave-images with 'Chun', 'Guan' and 'Chy' in order to prepare this visualization engineering platform.
15774187|NCT04661592|Device|NeuroCatch Platform|To elicit the ERP components of interest in this study (N100, P300, N400), proprietary auditory stimulus sequences will be administered using the NeuroCatch™ Platform version 2.0, an investigational medical device. Each sequence consists of tones and word pairs to elicit the various components of interest. Version 2.0 of the NeuroCatch™ Platform consists of a computerized acquisition software which presents the stimulus, acquires the data and presents the amplitude and latency values of the ERP components (N100, N400, P300)
15774188|NCT04661579|Biological|RTS,S/AS01E|Vaccine
15774189|NCT04661579|Biological|Abhayrab rabies vaccine|Vaccine
15774190|NCT04661566|Behavioral|"Basic Education (Education)"|All participants will receive the basic educational component in the Mission Wellness app. This component will contain text and media (e.g., images, videos) to teach basic SRH topics. The exact information in this component will be determined by an assessment of baseline SRH knowledge at the start of the intervention.
15774191|NCT04661566|Behavioral|"Narrative Videos (Narratives)"|The narrative video component is a motivation-based component that includes stories of individuals engaging in positive and negative SRH behaviors that lead to either positive or negative outcomes, respectively, in a video format.
15774192|NCT04661566|Behavioral|"Skills Building Videos (Skills)"|The skills-building videos component is a component rooted in behavioral skills that involves the provision of information on how to perform or engage positive SRH behaviors (e.g., correctly using a condom, what to expect when having a Pap smear) via instructional videos.
15774193|NCT04661566|Behavioral|"Interactive Scenarios (Scenarios)"|The interactive scenarios are a behavioral skills-building component that walks through conversations surrounding SRH with select individuals (e.g., partner, healthcare provider), providing suggestions on how to have these conversations and why these conversations are important to have.
15774194|NCT04661566|Behavioral|"Future Life Planning Tool (Future)"|The future life planning tool is a motivation-based component contains a series of questions to help users plan future goals to put current decision making related to SRH into perspective and provide suggestions on how to stay healthy now to be able to achieve those goals later.
15774195|NCT04661566|Behavioral|"Epidemiological Risk Scenario (Risk)"|The risk component is an information- and motivation-based component with tailored epidemiological risk information about relative risk of contracting a specific STI and/or having an unintended pregnancy. Relative risk information will be determined by adjusting variables within the component (e.g., number of partners within the last month, percent of time using condoms).
15774196|NCT04661553|Device|"Mueller's polarimetric colposcopy Group 1"|"Determination of the best polarimetric biomarkers reflecting the status of the cervical microstructure throughout its remodeling process due to the pregnancy in a population with a low-risk premature birth. This polarimetric biomarkers should make it possible to accurately determine the time remaining before childbirth for a normal pregnancy and, therefore, to monitor the regular advancement of the gestation."
15774197|NCT04661553|Device|"Mueller's polarimetric colposcopy Group 2"|"Determination of the best polarimetric biomarkers reflecting the status of the cervical microstructure throughout its remodeling process due to the pregnancy in a population at high-risk of preterm birth.
~This polarimetric biomarkers should make it possible to accurately determine the time remaining before childbirth for an abnormal pregnancy and, therefore, to predict premature childbirth."
15774198|NCT04661540|Drug|CM4620-IE (Injectable Emulsion)|Auxora is an injectable emulsion containing 1.6mg/ML of the active pharmaceutical ingredient CM4620. Auxora will be administered intravenously as a continuous infusion
15774199|NCT04661540|Drug|Placebo|Matching placebo is an injectable emulsion containing no active pharmaceutical ingredient. Placebo will be administered intravenously as a continuous infusion
15774200|NCT04661527|Drug|Sarilumab|Treatment with Sarilumab 200 mg IV x 2 doses 24 hours apart for first 5 patients. If no severe AE and no significant improvement within 48 hours, the dose will be increased for subsequent patients to 400 mg IV for the first dose and 200 mg or 400 mg IV for the second dose 24 hours later. Te second dose will be decided at the investigators discretion.
15774201|NCT04661514|Drug|Psilocybin|Psilocybin-assisted psychotherapy
15774202|NCT04661501|Device|AlloDerm|Acellular Dermal Matrices (ADMs) are breast reconstruction material. They are donated cadaveric dermis that is aseptically processed or sterilized in order to remove cellular and immunogenic components to prevent host reactions.
15774203|NCT04661501|Device|AlloMax|Acellular Dermal Matrices (ADMs) are breast reconstruction material. They are donated cadaveric dermis that is aseptically processed or sterilized in order to remove cellular and immunogenic components to prevent host reactions.
15774204|NCT04661501|Device|DermACELL|Acellular Dermal Matrices (ADMs) are breast reconstruction material. They are donated cadaveric dermis that is aseptically processed or sterilized in order to remove cellular and immunogenic components to prevent host reactions.
15774205|NCT04661501|Device|Flex HD|Acellular Dermal Matrices (ADMs) are breast reconstruction material. They are donated cadaveric dermis that is aseptically processed or sterilized in order to remove cellular and immunogenic components to prevent host reactions.
15774206|NCT04661488|Device|AI driven triage-system|AI driven triage-system
15774207|NCT04661475|Drug|Dexmedetomidine Injection [Precedex]|ECT and anaesthetic treatment protocols will be determined by the local ECT services. ECT being given twice a week. The anesthetic induction agent of choice will usually be propofol, with thiopental permissible as an alternative. For safety reasons, any drug contraindicated to be given with DEX will be avoided. Especially the once known to decrease arterial pressure and heart rate excessively. Oral psychotropic medication to be continued by the patient's treating clinical team will remain unchanged where possible for at least the first 4 ECT treatments, and ideally until end of ECT. Eligible subjects will be allocated randomly to receive either 0.5µg/kg dexmedetomidine add on (diluted to 10 ml with 0.9% saline) at a steady rate of 1 ml/min, for 10 min.Participants in the two groups will receive DEX or Saline adjunct thrice weekly for 3 weeks.
15774208|NCT04661475|Drug|Normal saline|while patients in the Control group will be infused with 10 ml of 0.9% saline at the same rate, over 10 minutes before anesthesia induction for ECT procedure.
15774209|NCT04661462|Other|online survey|We invite volunteers after COVID-19 to participate in an online survey.
15774210|NCT04661449|Other|Comprehensive lifestyle intervention|Feeding guidance: promoting exclusive breastfeeding and healthy diet (Pediatrician). Motor development assessment and guidance: Alberta Infant movement scale (AIMS) evaluation, guidance for motor development (Rehabilitation Therapist). Healthcare education: improvement of environmental exposure (Pediatrician).
15774211|NCT04661436|Diagnostic Test|Contrast-Enhanced Ultrasound|"The research will study the qualitative analysis indicators of contrast-enhanced ultrasound, including: enhancement uniformity, enhanced range, presence or absence of enhancement defect area, presence or absence of nourishing blood vessels, etc.; and quantitative analysis indicators, including: peak time, peak intensity, rising slope, Area under the curve, etc., analyze the correlation between the changes of various parameters before and after neoadjuvant treatment（NAT） and the pathological response of patients, and try to find indicators and cut-off values that can predict and early evaluate the efficacy.
~This study will study the qualitative and quantitative parameters of MRI-enhanced scanning and the changes of DWI parameters, analyze the correlation between the parameters of patients before and after NAT and pathological response, and try to find indicators and cut-off values that can predict and early evaluate the efficacy."
15774212|NCT04661423|Other|Remote Automated Monitoring System|The patient will be monitored with conventional monitoring devices as well as the MultiSense patch.
15774266|NCT04661007|Drug|R-CHOP|R-CHOP is a combination regimen consisting of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone. R-CHOP will be administered at protocol defined timepoints based on the groups participants are assigned.
15774646|NCT04657874|Other|Placebo|Oral tablet without the active principle
15774213|NCT04661410|Behavioral|Reward Re-Training|A brief, 10-session group-based behavioral treatment that is designed to indirectly change binge eating by directly focusing on building a more rewarding life. RRT hypothesizes that reductions in binge eating will occur as life becomes more rewarding because individuals will no longer need to rely on binge eating as a primary source of momentary reward. RRT notes that in order to live a satisfying life, individuals need to experience an adequate amount of reward in two overlapping yet distinguishable domains: momentary reward (i.e., the active experience of pleasure in the moment) and sustained reward (i.e., a deeper and more long-lasting sense of fulfillment and meaning that arises from building a personally valued life). A key aspect of RRT is an emphasize on building lasting and meaningful social relationships given the clear evidence that social connectedness can enhance both momentary reward and sustained reward.
15774214|NCT04661410|Behavioral|Supportive Therapy|A brief, 10-session group-based treatment that is designed to instill hope and optimism and to increase social connection and support through a non-directive group leader that allows the patients to determine the focus of each session. The group leader will act as an empathetic provider by using reflective listening, eliciting and validating affect, and offering empathic comments.
15774215|NCT04661397|Drug|Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC|Participants will receive a single dose of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC tablet orally as per assigned treatment sequence.
15774216|NCT04661397|Drug|Darunavir|Participants will receive a single dose of Darunavir orally as per assigned treatment sequence.
15774217|NCT04661397|Drug|Emtricitabine/Tenofovir Alafenamide|Participants will receive a single dose of Emtricitabine/Tenofovir Alafenamide tablet orally as per assigned treatment sequence.
15774218|NCT04661397|Drug|Cobicistat|Participant will receive a single dose of Cobicistat tablet orally as per assigned treatment sequence.
15774219|NCT04661384|Biological|IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes|Given ICV
15774220|NCT04661371|Procedure|Laparoscopic cholecystectomy|"Method of operation
~Surgery was started under general anesthesia
~A trocar of 10 mm was placed on the navel, 5 mm under the blade, and 5 mm trocar was placed on the right upper abdomen.
~Pneumoperitoneum was performed using CO2 gas in the abdominal cavity.
~Dissection started from Calot's triangle and the operation was performed by retrograde cholecystectomy.
~The excised gallbladder was placed in a laparoscopic pocket and extracted through the umbilicus.
~The trocar was removed and the skin was sutured
~On the 1st day after surgery, hematology, blood chemistry, urine, blood clotting, and chest x-rays were performed. (Inspection and treatment were performed according to the current clinical pathway of gallbladder surgery)"
15774223|NCT04661345|Other|Proteomic analysis of synovial fluids|Characterization of the proteome of infected/aseptic synovial fluid for the identification of molecular hallmarks strictly related to the presence of a bacterial infection mediated by coagulase-negative Staphylococci
15774224|NCT04661345|Other|Proteomic analysis of the isolated coagulase-negative Staphylococci|Characterization of the secretome of coagulase-negative Staphylococci isolated from infected prosthetic implants
15774225|NCT04661319|Procedure|video editing training|"The subject's preoperative residency year, instrument experience, open surgery experience, laparoscopic surgery experience, and preoperative instrument proficiency are evaluated.
~Basic anatomical and scientific education for laparoscopic cholecystectomy, practice laparoscopic instruments for at least 30 minutes every other week, and observe 3 cases of laparoscopic cholecystectomy.
~Select a random experimental group.
~For each selected group, 3 cases of surgical observation or 3 cases of video editing are performed.
~Both groups operated on 10 cases, and both groups were discharged from the hospital after undergoing the same recovery procedure after the same operation."
15774226|NCT04661306|Behavioral|SHUTi (Sleep Healthy Using the Internet)|Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program
15774227|NCT04661293|Biological|Autologous Muscle Derived Cells (AMDCs)|
15774228|NCT04661280|Drug|Donepezil|Donepezil 5 mg per day during one month, then 10 mg per day during 5 months.
15774229|NCT04661267|Dietary Supplement|Stem Cell Support Formula|This liquid supplement contains the following ingredients: chondroitin sulfate, glucosamine sulfate, vitamin C (ascorbic acid), curcumin and Bioperine®, resveratrol, L-carnosine, bitter melon, and vitamin D.
15774230|NCT04661267|Dietary Supplement|Placebo|The placebo comparator will look and taste similar without the active ingredients of the Stem Cell Support Formula.
15774231|NCT04661254|Other|Lymphapheresis|- From the blood product of lymphapheresis: Autologous naïve regulatory CD45RA+CD4+CD25+FoxP3+ T lymphocytes (Tregs) selected and amplified ex vivo; obtained by selection and sorting of CD4+CD25 +CD127lowCD45RA+ cells, derived from lymphapheresis and amplified ex vivo for 10 +/- 1 days, under cGMP condition in the presence of IL2 and Rapamycin
15774232|NCT04661241|Other|Automatic DRT/VIM target-recognition method using MR-SISET and ML approaches|The proposed sequence (<15 minutes) will be added as a supplementary sequence only for the preoperative imaging for subjects who agree to participate: a 3D multi-echo GRE sequence will be performed during a preoperative MR imaging, using the following parameters: field of view = 220x170x75 mm3, matrix = 176x136x60, 1.25-mm isotropic resolution, flip angle = 22 degrees, TR = 92 ms, 20 TEs = 1.90 - 45.98 ms with echo spacing of 2.32 ms, bandwidth = 840 Hz/pixel.
15774233|NCT04661241|Other|Routine clinical MRI protocol|MRI will be performed using 3T scanner (Skyra, Siemens, Erlangen, Germany). All patients will undergo preoperative MRI of the brain including routine clinical MRI protocol (T1-/T2-weighted and diffusion imaging) under general anesthesia to reduce movement artifacts.
15774234|NCT04661228|Diagnostic Test|Composite International Diagnostic Interview 5th version (CIDI 5.0)|Observational study assessing prevalence of mental and substance use disorders in the general population
15774310|NCT04660734|Procedure|Fractures of the posterior structures of the acetabulum treated by fixation using the Kocher-Langenbeck approach.|Fracture fixation of posterior structures of acetabulum by using the surgical procedure of Kocher-Langenbeck approach
15774311|NCT04660721|Combination Product|sFilm-FS|sFilm-FS is a sterile bio-compatible bio-absorbable patch embedded with lyophilized powders of Human Fibrinogen, Human Thrombin and calcium chloride.
15774235|NCT04661202|Other|combined resistance and aerobic exercise training|"A supervised moderate-intensity exercise training session, which will include aerobic exercise with a stationary exercise bike, resistance exercise using dumbbell, theraband band, or gym ball for each major muscle groups and core muscles (including pelvic floor muscle (PFM) training with biofeedback), and stretching exercise, twice a week for 8 weeks. All exercises will be individualized based on participant's heart rate reserve and Rate of Perceived Exertion (RPE). An oximeter and a sphygmomanometer will be used to monitor the heart rate, oxygen saturation and blood pressure of the participants to ensure safety.
~A home exercise program will include a walking exercise for 30 minutes per day and a PFM training with the aim of completing 1~3 sets of 8~12 submaximal contraction of PFM by holding 6~10 seconds with 12~20 seconds of rest between each contraction, and it will end with 3 maximal PFM contractions by holding 1~3 seconds 3~6 seconds of rest between each contraction."
15774236|NCT04661189|Behavioral|Physical exercise training|Participants will be encouraged to complete exercise training programs in the form of video capsules available via Facebook or Youtube, created by kinesiologists of the Montreal Heart Institut EPIC prevention center. The videos last about 15 minutes and include a warm-up of 3 to 5 minutes, followed a 10-minute training and finally a 2-minute cool-down period. The exercises on video do not require any equipment and integrate, depending on the video, aerobic, muscular strengthening, flexibility and/or balance exercises. Several intensities are described according to the participants' level. Participants will be invited to perform exercise sessions at least 5 times a week, and will be monitored weekly by phone by a member of the research team. The exercise sessions can be performed at home using the video training program, as well as in sports centre or outdoors. For each session, participants have to report its duration, intensity, and the nature of the activity via a follow-up agenda.
15774237|NCT04661189|Behavioral|Cognitive training|Participants will be encouraged to perform sessions of cognitive training 3 times per week (30 minutes/session). Two of these sessions will involve computer or tablet-based attentional control training targeting dual-tasking, updating and working memory, as well as inhibition and switching. Difficulty of cognitive training will be tailored to participants' performances. The remaining session will consist of memory training. Participants will be instructed different mnemotechnic, as well as be taught about memory in aging in general. The memory training will be provided by videos capsules. To track adherence to cognitive training, participants will be asked to complete a journal and mark days and times where they took part in the various cognitive training sessions.
15774238|NCT04661176|Diagnostic Test|miR Sentinel™ PCC4 Assay|This study is a prospective clinical utility study. Urine samples will be collected from participants for the miR Sentinel™ PCC4 Assay, which interrogates the expression profile of 442 small non-coding RNAs to classify disease status as having no molecular evidence of prostate cancer (NMEPC) or molecular evidence of low-, intermediate- or high-risk prostate cancer.
15774239|NCT04661163|Other|Psychotherapy|Virtual Reality Avatar Therapy is a psychotherapeutic intervention targeting auditory hallucinations
15774244|NCT04661137|Drug|Selinexor 60 MG|Selinexor 60 mg PO on days 1, 8 and 15
15774245|NCT04661137|Drug|Selinexor 80 MG|Selinexor 80 mg PO on days 1, 8 and 15
15774246|NCT04661137|Drug|Selinexor 100 MG|Selinexor 100 mg PO on days 1, 8, 15 and 22
15774247|NCT04661137|Drug|Carfilzomib|56 mg/m2 IV on days 1, 8 and 15
15774248|NCT04661137|Drug|Pomalidomide|4 mg PO daily for 21 days
15774249|NCT04661137|Drug|Daratumumab|16 mg/kg IV days 1, 8, 15 and 22 for cycles 1-2; days 1 and 15 for cycles 3-6; day 1 for cycle 7 and on
15774250|NCT04661137|Drug|Dexamethasone|20 mg if ≥ 75 years old and 40 mg if < 75 years old on days 1, 8, 15 and 22
15774251|NCT04661124|Device|SPECTRALIS|ophthalmic imaging device with head and chinrest
15774252|NCT04661124|Device|SPECTRALIS with Flex Module|ophthalmic imaging device on mobile instrumentation stand
15774253|NCT04661111|Device|Hymovis® ONE (32 mg/4 ml)|Hymovis® ONE is a clear hydrogel. The conjugate compound is constituted by a partial hexadecylamide of hyaluronic acid, which is produced by a fermentation process. Hymovis® ONE is a CE-marked Class III Medical Device intended for intra-articular injection.
15774254|NCT04661098|Procedure|(Darwish hymenotomy technique)|Formation of an annular hymen in cases of postpubertal imperforate hymen using a laparoscopic trocar (Darwish hymenotomy technique)
15774255|NCT04661085|Diagnostic Test|Broader Medical history and clinical tests|Patients will be treated with standard care plus additional blood tests, urine culture and urine flow cytometry,
15774256|NCT04661046|Drug|Traditional Chinese Medicine|Chinese medicine prescription
15774262|NCT04661020|Drug|CD19 CAR-T cells|Each subject receive CD19 CAR T-cells by intravenous infusion
15774263|NCT04661007|Drug|tafasitamab|tafasitamab will be administered at protocol defined timepoints based on the groups participants are assigned.
15774264|NCT04661007|Drug|lenalidomide|lenalidomide will be administered orally at protocol defined timepoints based on the groups participants are assigned.
15774265|NCT04661007|Drug|parsaclisib|parsaclisib will be administered at protocol defined timepoints based on the groups participants are assigned.
15774312|NCT04660721|Combination Product|TACHOSIL®|TACHOSIL® is a fibrin sealant patch composed of an equine collagen patch coated with Human Fibrinogen and Human Thrombin.
15774267|NCT04660994|Other|Educational game|"The Yapouni educational game is based on a hot air balloon that will fly according to the number of hours the child has slept with his/her CPAP / NIV. Thus, the longer the child sleeps with his/her CPAP / NIV, the farther and higher his/her hot air balloon will fly in the sky. The game includes wild cards and rewards that are worked out with the child and his/her parents for an optimal individualized adaptation.
~The game is explained at Necker Hospital during the therapy education for CPAP/NIV and used at home for 1 month."
15774268|NCT04660981|Behavioral|Antenatal education|Training Program on Fear of Childbirth Based on Motivational Interview Method
15774269|NCT04660968|Behavioral|Dyadic health behaviour change intervention|The dyadic behaviour change intervention adopts a dyadic coping perspective wherein appraisal of shared responsibility, agreement on tasks, and collaboration are fostered throughout the intervention. The intervention will target four behaviour goals: reducing overall caloric intake, substituting empty calorie foods with healthier alternatives, reducing sedentary behaviour, and increasing physical activity. The specific behavioural change strategies will include motivational interviewing, self-monitoring, goal setting, stimulus control, problem solving, and relapse prevention. Each session will also include a short education component on healthy eating to improve participants' adherence to the updated Canada's Food Guide. Participants will have access to web-based exercise training sessions. Intervention sessions will be delivered online.
15774270|NCT04660968|Behavioral|Dyadic nutrition counselling intervention|The couples-based education nutrition intervention will provide extensive information on healthy eating. However, it will not include any behavioural change principles. Topics will be based on Dietitians of Canada's Practice-based Evidence in Nutrition (PEN) discussions in the database that focus on healthy eating for older adults. The topics covered will include increasing fruits and vegetables, hidden (empty) calories, how to read food labels, portion control, reducing salt and saturated fat, plant-based proteins, and eating for healthy bones. Participants in this group will also be told to increase their levels of physical activity to 150 minutes of moderate to vigorous physical activity per week, as per the Canadian Guidelines. Participants will have access to web-based exercise training sessions. However, physical activity will not be discussed explicitly during the intervention. Intervention sessions will be delivered online.
15774271|NCT04660955|Other|No Intervention - Observational study with MRI|90 minute MRI of the knees
15774272|NCT04660929|Biological|CT-0508|anti-HER2 CAR macrophages
15774273|NCT04660916|Drug|Isotretinoin|The effects of isotretinoin on morphology, growth rate, and thickness of the nail plate
15774274|NCT04660903|Procedure|Autologous fat cell transplantation|Up to 75 ml of fatty tissue mixture fluid
15774275|NCT04660890|Drug|ALXN2050|ALXN2050 will be administered orally twice daily as powder-in-capsule.
15774276|NCT04660890|Drug|ALXN2050-matching Placebo|ALXN2050-matching placebo will be administered orally twice daily as placebo powder-in-capsule.
15774277|NCT04660890|Drug|Moxifloxacin|Moxifloxacin will be administered as a single oral dose.
15774278|NCT04660890|Drug|Moxifloxacin-matching Placebo|Moxifloxacin-matching placebo will be administered as a single oral dose.
15774279|NCT04660877|Dietary Supplement|Cheddar Cheese|20g of protein from cheddar cheese
15774280|NCT04660877|Dietary Supplement|Milk|20g of protein from milk
15774281|NCT04660864|Device|Nasal cavity cooling device.|The RhinoChill® system cools by intranasal evaporation of a liquid coolant sprayed onto the surface of the nasal cavity. The RhinoChill® system is intended for use for the relief of pain and symptoms associated with acute migraine attack.
15774282|NCT04660851|Behavioral|Coached|10-weeks of diet coaching weekly by telephone to improve dietary protein intake
15774283|NCT04660838|Other|ACB intervention|Stopping and/or switching ACB medication to an alternative
15774284|NCT04660825|Other|A resistance band exercise programme|A resistance band based exercise programme lasting six months
15774285|NCT04660825|Other|Control|Maintained usual physical activity
15774286|NCT04660812|Drug|etrumadenant|Dual adenosine receptor (A2aR and A2bR) antagonist
15774287|NCT04660812|Drug|zimberelimab|Zimberelimab is a fully human anti-PD-1 monoclononal antibody
15774288|NCT04660812|Drug|mFOLFOX-6 regimen|mFOLFOX-6 regimen is administered as part of standard chemotherapy regimen
15774289|NCT04660812|Drug|bevacizumab|Bevacizumab is administered as part of standard chemotherapy regimen
15774290|NCT04660812|Drug|regorafenib|Regorafenib is adminstered as part of standard chemotherapy regimen
15774291|NCT04660812|Drug|AB680|AB680 is a cluster of differentiated CD73 Inhibitor
15774292|NCT04660799|Drug|Rituximab IV|Rituximab will be administered intravenously through Cycle 1-8 at a standard dose of 375 mg/m2 (milligram per square meter)
15774293|NCT04660799|Drug|Rituximab SC|Rituximab will be administered subcutaneously through Cycle 2-8 at a dose of 1400 milligram (mg)
15774294|NCT04660799|Drug|Rituximab IV|Rituximab will be administered intravenously in Cycle 1 at a standard dose of 375 mg/m2
15774295|NCT04660799|Drug|Cyclophosphamide|Cyclophosphamide will be administered IV at a dose of 750 mg/m2
15774296|NCT04660799|Drug|Doxorubicin|Doxorubicin will be administered IV at a dose of 50 mg/m2
15774297|NCT04660799|Drug|Vincristine|Vincristine will be administered IV at a dose of 1.4 mg/m2
15774298|NCT04660799|Drug|Prednisone|Prednisone will be administered orally at a dose of 100 mg/day
15774299|NCT04660799|Drug|Paracetamol|All participants are required to receive 1000 mg oral paracetamol as premedication prior to starting each infusion of rituximab
15774300|NCT04660799|Drug|Diphenhydramine hydrochloride or alternative antihistamine|All participants are required to receive 50-100 mg oral diphenhydramine hydrochloride or alternative antihistamine as premedication prior to starting each infusion of rituximab
15774301|NCT04660786|Drug|triamcinolone acetonide|local immunosuprresent
15774302|NCT04660786|Drug|vitamin D|local immunomodulator
15774303|NCT04660773|Device|NB UVB phototherapy|ultraviolet phototherapy sessions
15774304|NCT04660773|Drug|Pregabalin|oral medication
15774305|NCT04660760|Drug|Paclitaxel|Given IV
15774306|NCT04660760|Other|Quality-of-Life Assessment|Complete questionnaires
15774307|NCT04660760|Biological|Ramucirumab|Given IV
15774308|NCT04660760|Drug|Trifluridine and Tipiracil Hydrochloride|Given PO
15774309|NCT04660747|Drug|Oral anticoagulant|Direct oral anticoagulants or vitamin K antagonists
15844859|NCT04084197|Drug|HIP1801|Tamsulosin 0.4mg
15774314|NCT04660695|Device|EUS-guided gastroenterostomy|Firstly, un upper digestive endoscopy is performed with a conventional gastroscope. A guidewire is passed through the malignant lesion causing the gastric outlet obstruction. Once the guidewire is located in the distal duodenum/proximal jejunum, a nasobiliary drain (Nasal Biliary Drainage Sets, Cook medical, Indiana) is advanced over the guidewire until its distal end is placed in the distal duodenum/jejunum. At this point the gastroscope is substituted by a therapeutic echoendoscope. With the echoendoscope in place, the target bowel loop is filled with saline combined with methilene blue and radiopaque contrast. The echoendoscope is used to identify the target bowel loop. AFter identifying the target, a lumen apposing metal stent (Axios, Boston Scientific, Massachusetts) is deployed across the gastric and bowel using its electrocautery enhanced deployment device.
15774315|NCT04660682|Other|Modified static cross-body posterior shoulder stretching|For the modified cross-body position patient will be positioned in the side-lying position to limit the scapular abduction, and the patient aligned his/her forearms to limit the ER of the humerus while moving into horizontal adduction (HAdd). First, we will ask the patient to pull his/her arm into HAdd to the physiological barrier of the ROM, and then the patient will perform active-assistive static stretching with the help of the other hand for 30 seconds. The stretching will perform five repetitions with 10-sec rest between stretches. Each stretching will begin from a new physiological barrier of the HAdd ROM. Patients will also receive the standard physiotherapy program consists of physical agents, posture, proprioceptive, and strengthening exercises. The treatment program will be performed 5 days a week under the physiotherapist's supervision and 2 days a week as a home program for 8 weeks.
15774316|NCT04660682|Other|Traditional static cross-body posterior shoulder stretching|For the traditional static cross-body posterior shoulder stretching, in the standing position, the patient will perform cross-body stretch alone by active-assistive pulling the humerus across the body into HAdd with the opposite arm, without concern for scapular stabilization for 30 sec. The stretching will perform five repetitions with 10-sec rest between stretches. Each stretching will begin from a new physiological barrier of the HAdd ROM. Patients will also receive the standard physiotherapy program consists of physical agents, posture, proprioceptive, and strengthening exercises. The treatment program will be performed 5 days a week under the physiotherapist's supervision and 2 days a week as a home program for 8 weeks.
15774317|NCT04660682|Other|Control Group|In sham stretching, the patient will be positioned in the traditional static cross body posterior shoulder stretching position, and then the patient will perform active-assistive HAdd ROM without enough stretching of the relevant tissue. Active assistive ROM will be stopped before reaching the individual PST measurement result (in this way, sham stretching will be performed without proper stretching of the relevant tissue). The HAdd ROM exercise will be performed 5 times. Patients will also receive the standard physiotherapy program consists of physical agents, posture, proprioceptive, and strengthening exercises. The treatment program will be performed 5 days a week under the physiotherapist's supervision and 2 days a week as a home program for 8 weeks.
15774318|NCT04660669|Other|ESDM intervention|Early Start Denver Model (ESDM) intervention with remote parental training/ supervision versus intensive ESDM intervention.
15774319|NCT04660669|Other|MOOC|Massive Online Open Course: a teaching and learning intervention based on instrumental and interactive teaching situations
15774320|NCT04660656|Diagnostic Test|5 repetition sit-to-stand test|"The sit-to-stand test with five repetitive movements is used as standard in our clinical routine to determine the patient's mobility objectively. The first measurement is performed preoperatively during surgery (baseline). The follow-up measurement is performed six weeks after the operation and one year after the operation in the clinic.
~A stool with a fixed height is used for this purpose. The patient should cross his arms over the chest and then slowly stand up until the knees are full of space. Then the patient sits down again, of course without support of the arms. The duration of the five movements is recorded using a stopwatch. The complete movement starts after the Go command and ends when the patient is fully upright after the fifth movement. This duration is written down as the patient's score."
15774321|NCT04660643|Drug|Tirzepatide|Administered SC
15774322|NCT04660643|Other|Placebo|Administered SC
15774323|NCT04660630|Diagnostic Test|Gene detection of therapeutic drugs for chronic cardiovascular and cerebrovascular diseases|According to the results of drug gene chip detection, we combined with the clinical characteristics of the patient to choose more suitable cardiovascular and cerebrovascular treatment drugs.
15774324|NCT04660630|Behavioral|Regular follow-up and patient education|The subjects received regular follow-up and patient education.
15774325|NCT04660604|Device|Graston Technique®|Graston technique, one of the soft tissue mobilization techniques, has also been found to be effective method that affects muscle strength, performance and endurance through activation of muscle and nervous systems.
15774326|NCT04660591|Device|femoral stem in hip arthroplasty|using lateral approach to the hip we will compare the effect of femoral stem length on the oncological and functional outcomes in patients with proximal femoral metastasis.hip arthroplasty is a surgical procedure that involves changing the head of the femur (the ball) with or without replacing the articular surface of the acetabulum (the socket ).and replacing it with metal head based on a stem covered with cement to fix it to the bone of the femur.
15774327|NCT04660578|Procedure|ACCSS|A. Chohan Continuous Squeezing Suture (ACCSS)
15774328|NCT04660565|Drug|Prednisone and Belimumab|Prednisone/prednisolone: started at 0.6-0. 8mg/kg.d for 2 to 4 weeks, tapered at 5mg per 1-2 weeks to equal to or less than 5mg per day in 3 months. Belimumab will start at the same time as the prednisone induction.
15774329|NCT04660565|Drug|Prednisone|Prednisone/prednisolone: started at 0.6-0. 8mg/kg.d for 2 to 4 weeks, tapered at 5mg per 1-2 weeks to equal to or less than 5mg per day in 3 months.
15774330|NCT04660552|Device|Cognilum TM: Light Treatment Condition|The children will wear the CognilumTM device for approximately 15 minutes at a time, twice a week, for a period of 8 weeks.
15774367|NCT04660292|Other|Traditional Physical therapy|BASELINE TREATMENT INCLUDES TENS and Hot PACKS
15774335|NCT04660526|Other|Rapid cardiac arrest recognition that triggers immediate priority EMS/first responder dispatch by 911 operators|EMS first responders will recognize cardiac arrest and respond immediately, increasing time to dispatch
15774336|NCT04660526|Other|Systematic bystander resuscitation instruction by 911 operators|911 operators will be able to describe how to administer CPR over the phone.
15774337|NCT04660526|Other|Comprehensive community training of lay people in CPR and AED use.|Training of lay people regarding CPR and AED use.
15774338|NCT04660526|Other|Optimized first responder performance including earlier use of AEDs.|First responders will recognize where AEDs are located and use them appropriately
15774339|NCT04660513|Procedure|Bariatric surgery|Subjects with morbid obesity underwent bariatric surgery
15774340|NCT04660500|Other|PD Drivers Using AV Technologies On-road|All drives will include events to assess the impact of in-vehicle information systems (IVIS) and advanced driver assistance systems (ADAS) on the driving performance (driving errors) of drivers with PD. For IVIS the investigators will include options to assess errors with lane maintenance (with and without the lane departure warning system) and signaling (with and without blind spot detection). For ADAS the investigators will include conditions to assess errors in speeding (with and without adaptive cruise control) and lane exceedances (with and without lane keeping assist).
15774341|NCT04660461|Drug|Lansoprazole 30mg|Subjects are randomized to recieve Lansoprazole 30mg/day or placebo during 8 weeks. After a washing-out period of 15 days, subjects will receive the other treatment (cross-over design) during 8 weeks
15774342|NCT04660461|Drug|Placebo|Subjects are randomized to recieve Lansoprazole 30mg/day or placebo during 8 weeks. After a washing-out period of 15 days, subjects will receive the other treatment (cross-over design) during 8 weeks
15774343|NCT04660448|Diagnostic Test|Bedside lung ultrasound examination|Lung ultrasound exploring 12 areas (6 in each lung) at 12 +/- 6 hours and at 48-72 hours from PICU admission. Clinical and analytical data collection coinciding with ultrasound imaging and during follow-up while admitted to PICU.
15774344|NCT04660435|Diagnostic Test|Thymidine kinase activity|DiviTum® assay determines the enzymatic activity of TK in serum samples
15774349|NCT04660409|Diagnostic Test|Blood test for serum Adropin|Blood test for serum Adropin
15774350|NCT04660396|Device|BVA-100|"The BVA-100 is a software package designed to calculate human blood volume using the method of tracer dilution. It uses tagged serum albumin (a commonly used tag is 131I, resulting in 131I -HSA). Data inputs to the software come from the measured characteristics of subject blood samples (hematocrit and tracer concentration) and tracer calibration standards. The package also calculates the subject expected (or ideal) blood volume from physical parameters. Hyper- or hypovolemia, associated red blood cell volumes, and transudation rate are reported, with statistics showing the quality of the results. The subject blood samples and calibration standards are measured in a gamma counter, whose output is automatically, or manually, input to this calculation program."
15774351|NCT04660383|Device|Inspiratory Muscle Training|Patients will be submitted to three weekly IMT sessions in three different intensities for a period of twelve weeks, totaling 36 sessions.
15774352|NCT04660370|Drug|CKD-348|QD, PO
15774353|NCT04660370|Drug|CKD-828, D097, D337|QD, PO
15774354|NCT04660357|Other|survey study|survey study
15774357|NCT04660331|Other|Communication Intervention|Undergo communication strategy intervention
15774358|NCT04660331|Other|Communication Skills Training|Undergo communication training sessions
15774359|NCT04660331|Behavioral|Healthcare Activity|Participate in interview
15774360|NCT04660331|Behavioral|Healthcare Activity|Undergo environmental scan
15774361|NCT04660331|Other|Survey Administration|Complete survey
15774362|NCT04660318|Device|Remote photoplethysmography for physiological parameters|physiological parameters will be acquired using the Remote photoplethysmography software simultaneously for the conventional parameters measurements (heart rate, respiratory rate, and oxygen saturation)
15774363|NCT04660318|Device|standard acquisition system for physiological parameters|physiological parameters will be acquired using the standard acquisition system for the conventional parameters measurements (heart rate, respiratory rate, and oxygen saturation)
15774364|NCT04660305|Drug|AT278|Concentrated rapid acting insulin aspart
15774365|NCT04660305|Drug|NovoRapid|Rapid acting insulin aspart
15774366|NCT04660292|Other|Maitland's mobilization|Maitland's techniques involve the application of passive and accessory oscillatory movements to spinal and vertebral joints to treat pain and stiffness.It has Five grades
15774368|NCT04660279|Diagnostic Test|Dynamic Whole-Body parametric PET/CT|Dynamic whole-body PET/CT imaging protocol
15774369|NCT04660266|Diagnostic Test|Liver Ultrasound|liver ultrasound examination, including gray-scale and seven Doppler examination
15774370|NCT04660253|Behavioral|LTP Plus Dads|
15774371|NCT04660240|Device|Abluminus Sirolimus Eluting Stent System (ASES)|"The procedure will be conducted in accordance with the CE mark instructions for use for the ASES.
~The need or not for postdilation in any segment of the stent will be at the discretion of the operator, seeking its adequate expansion and apposition. To consider PCI to be successful, residual stenosis must be less than or equal to 30% by angiography at the end of the procedure, including the absence of coronary dissection that compromises distal flow or a hemodynamically significant pressure gradient across the lesion."
15774372|NCT04660240|Device|Orsiro Sirolimus Eluting Coronary Stent System (OSES)|"The procedure will be conducted in accordance with the CE mark instructions for use for the OSES.
~The need or not for postdilation in any segment of the stent will be at the discretion of the operator, seeking its adequate expansion and apposition. To consider PCI to be successful, residual stenosis must be less than or equal to 30% by angiography at the end of the procedure, including the absence of coronary dissection that compromises distal flow or a hemodynamically significant pressure gradient across the lesion."
15774373|NCT04660227|Procedure|Exercise Trainning|Participants in the online exercise program group will be given a treatment protocol consisting of aerobic exercise and strengthening exercises in the presence of a physiotherapist for a total of 8 weeks, 2 days a week for 1 hour. Before starting the exercise, the risk of possible injury will be minimized by doing warm-up exercises and preparations will be made to start the exercise. Then, the exercise program will be started with aerobic exercise. Strengthening exercises will be planned for large muscle groups, targeting body parts such as hips, knees, shoulders, abdomen and trunk. In exercises, it is planned to do 2 sets of 10-15 repetitions using elastic band, free weights or body weight. The exercise program will be created according to the condition of the people and progression will be provided every 2 weeks. After the exercises are completed, cool down will be done with relaxation and stretching exercises.
15774374|NCT04660227|Other|Control Group|Participants in the control group will be put on the waiting list after all assessment methods have been applied and will be re-evaluated at the end of 8 weeks. After the final evaluations, they will be directed to the exercise group.
15774375|NCT04660214|Device|septotomy|endoscopic diverticulotomy
15774378|NCT04660188|Other|Multidisciplinary collaborative care arm|Study participants will be cared for by a team of healthcare professionals; an oncologist, a PCP and a pharmacist navigator.
15774379|NCT04660175|Other|non-resistance therapy|The non-resistance technique, created in Jaseng Hospital, is a combination of ischemic compression and mobilization It is a treatment that improves the limited range of motion of the cervical spine and relieves pain by applying ischemic pressure to the induration of the neck and at the same time firmly supporting the patient's head to give passive joint movements and completely relax.
15774380|NCT04660175|Other|acupuncture|According to the judgment of the oriental medicine doctor, select acupuncture point and tender spots such as BL10, TE14, GB20, GV16, etc. to a depth of 10 mm 6 -Self needle in 12 blood spots.
15774381|NCT04660175|Other|chuna|Chuna treatment is administered once a day during the hospitalization period. Chuna is Korean manual therapy using methods such as joint mobilization, joint distraction, fascia relaxation and manipulation.
15774382|NCT04660175|Other|pharmacoacupuncture|This is an oriental medical practice in which a certain amount of a drug extracted from a specific herbal medicine is injected with an injector to treat the patient's constitution, disease state, etc., and then injected into the treatment acupuncture points and body surface reaction points. Depending on the condition of the inpatient, acupuncture is used in parallel.
15774383|NCT04660175|Drug|Korean herbal medicine|Formulated with herbal medicinal and pack the extract in a pouch, and have the hospitalized patient take it once in the morning and afternoon for 30 minutes after meals.
15774384|NCT04660162|Device|Iontophoresis|By using the PeriIont (Perimed, Jarfalla, Sweden) device, 0.5 mL of a 10 mg/ml Sodium nitroprusside solution was used transdermally and ionised with a current strength of 200 µA for 1 minute.
15774385|NCT04660162|Other|Stepwise occlusion|The upper arm was occluded for 30 seconds with a pneumatic cuff up to 50 mmHg, 80 mmHg, 110 mmHg, 140 mmHg, and 170 mmHg. The volunteer had rest for 5 minutes between each occlusion procedure.
15774386|NCT04660136|Biological|contrast enhanced ultrasound|We injected the second generation, ultrasonic contrast agent (SonoVue, Bracco, Milan, Italy) as a bolus of 0.03 ml/kg through a three-way 20-gauge catheter in an antecubital vein, followed by a bolus of 5 ml saline solution (0.9% NaCl).CEUS was performed with a 7.5MHz linear probe and contrast-tuned technology, based on allow mechanical index and a real-time scan to ensure the preservation of the contrast agent. A low acoustic power setting was used, expressing a low mechanical index (MI), 0.09-0.14, of a 7.5 MHz linear probe.
15774387|NCT04660123|Drug|Bismuth Colloidal Pectin Granules Quadruple Therapy for H. Pylori Eradication|"Standard dose of proton pump inhibitor, bismuth , and 2 antibiotics, 14 days course.
~Standard doses of proton pump inhibitors are esomeprazole 20mg, rabeprazole 10mg (or 20mg).
~Omeprazole 20mg, lansoprazole 30mg, pantoprazole 40mg, alprazole 5mg, any one of these.
~Bismuth is colloidal bismuth pellets, 150mg, 2 times/d.
~Antibiotic Program:
~Scheme 1 Amoxicillin 1000 mg, 2 times/d; Clarithromycin 500mg, 2 times per day Scheme 2 Amoxicillin 1000 mg, 2 times/d; Levofloxacin 5001 times/2 times Scheme 3 Amoxicillin 1000 mg, 2 times/d; Furazolidone 100mg, 2 times/d. Scheme 4 Amoxicillin 1000 mg, 2 times/d; Metronidazole 400mg, 3 times/d or 4 times/d Scheme 5 Amoxicillin 1000 mg, 2 times/d; Tetracycline 500mg, 3 times/d or 4 times/d Scheme 6 Tetracycline 500mg, 3 times/d or 4 times/d; Metronidazole 400mg, 3 times/d or 4 times/d Scheme 7 Tetracycline 500mg, 3 times/d or 4 times/d; Furazolidone 100mg, 2 times/d."
15774388|NCT04660110|Drug|IPT with Dihydroartemisinin Piperaquine|A single dose/round of IPT with Dihydroartemisinin Piperaquine (40mg/320mg tabs, Fosun Pharmaceuticals)
15774478|NCT04659317|Drug|Oxycodone 5 mg Oral Tablet|Encapsulated Oxycodone 5 mg tablets x24, to take po q6 hours as needed
15774389|NCT04660097|Drug|Alotinib Plus Durvalumab-Platinum-Etoposide in First-line Treatment Extensive Small-cell Lung Cancer|This trial is single-armed IIb stage clinical trial to study the efficacy and safety of Alotinib Plus Durvalumab-Platinum-Etoposide in First-line Treatment Extensive Small-cell Lung Cancer . We use the outcome of CASPIAN trial as control group. The primary endpoint is ORR according to the RECIST 1.1, and secondary endpoints are PFS, OS, satety and life quality.
15774390|NCT04660084|Diagnostic Test|Ultra-rapid molecular point-of-care testing|"Ultra-rapid molecular testing (UR-MT) comprises automated detection using the new BioFire® FilmArray® Pneumonia plus platform (Biomérieux). The total turn-around time is <2 hrs.
~The UR-MT is combined with standard of care, comprising:
~Microbiological processing per current standard of care entails culture of respiratory tract samples according to national protocols to detect respiratory bacteria, identified using biochemical methods and/or matrix-assisted laser desorption/ionization time-of-flight (MALDI-TOF MS). Respiratory viruses are identified using real-time PCR (for metapneumovirus, rhinovirus, influenza A, influenza B, parainfluenza 1-3, RSV and SARS-CoV-2). The total turn-around time is up to 48 hrs."
15774391|NCT04660071|Other|ultrasonographic Assessment,|Ultrasound assessment was performed on rectus femoris (RF), vastus intermedius (VI), vastus medialis (VM) and vastus lateralis (VL) muscles using with an ultrasound-imaging device (Philips Medical Systems EPIQ 5 Release 5.0.2, Amsterdam).
15774392|NCT04660071|Other|Echo intensity Measurements|All images were analysed using the Image J software (Version 1.48v, National Institutes of Health, Bethesda, MD, USA) by two different analysers (five years and one-year of experience in US image analysis).
15774393|NCT04660045|Drug|Acalabrutinib|Acalabrutinib, oral, 100 mg BID, continuous
15774394|NCT04660032|Behavioral|Nudge|An electronic prompt (nudge) will be sent to the participant's obstetric care provider. The provider will receive a staff message in Epic (Penn Chart) that his/her patient has an upcoming postpartum visit. The message will be sent 1 week before the scheduled visit. The message will have patient-specific information including hypertensive diagnosis, blood pressure medication(s), gestational diabetes diagnosis, and primary care provider as listed in the Epic banner. The message will also have dot phrases for recommended counseling and contact information for UPHS primary care and cardiology providers. There will be example text recommending follow-up with primary care or cardiology; counseling on risk of future CVD; and recommending aspirin in a future pregnancy.
15774395|NCT04660019|Other|the scalp and ear acupuncture|Some stimulation areas with outstanding effects on certain symptoms are selected for acupuncture
15774396|NCT04660019|Other|sham acupuncture|Some stimulation areas with outstanding effects on certain symptoms are selected for acupuncture, and change acupuncture to auricular points sticker.
15774397|NCT04660006|Procedure|Cataract surgery|Patients undergoing uneventful cataract surgery were recruited to this study if they met the inclusion criteria of the three groups. Postoperative retinal vasculature measures, as recorded by the optical coherence tomography angiography imaging technique, were compared to baseline measures.
15774398|NCT04659993|Behavioral|Telemental Health Sessions, Support Groups and Questionnaires|Participants will complete initial online questionnaires lasting about 25-30 minutes as well as attend weekly support group meetings online. After 4 weeks, participants will complete seven online follow-up questionnaires that should take no longer than 30 minutes and again at the end of the study.
15774399|NCT04659980|Device|hilotherapy|continuous cooling of hands and feet at a constant temperature
15774400|NCT04659980|Device|frozen gloves|cooling of hands and feet using frozen gloves
15774401|NCT04659967|Behavioral|Virtual Training|Participants will receive a virtual training that is tailored to age-related hearing loss, use of non-custom personal amplification devices, and communication strategies.
15774402|NCT04659954|Other|Application O'DIDE|The intervention is the use of an application that aimed to favorize contact between the patient and the care team between the consultations.
15774403|NCT04659941|Biological|BCG vaccine|Using aseptic methods, 1 mL of Sterile Water for Injection, is added to one vial of vaccine. Gently swirl the vial until a homogenous suspension is obtained. Avoid forceful agitation which may cause clumping of the mycobacteria. Drop the immunizing dose of 0.1 mL of BCG VACCINE from the syringe and needle onto the cleansed surface of the skin.
15774404|NCT04659928|Device|High volume evacuation (HVE)|Intra oral suction will be done and during the procedure,bacterial colony forming units (cfus) will be captured during dental care by placing large format petri dishes containing bacterial culture media in the dental operatory with open lids. Once aerosol capture is complete, petri dishes will be incubated and quantified under BSL-2 safety conditions in the lab.Patient will be given hydrogen peroxide rinse.
15774405|NCT04659928|Device|Extraoral vacuum aspirator (EVA)|Extraoral suction connected to dental suction will be used and bacterial colony forming units (cfus) will be captured during dental care by placing large format petri dishes containing bacterial culture media in the dental operatory with open lids. Once aerosol capture is complete, petri dishes will be incubated and quantified under BSL-2 safety conditions in the lab.Patient will be given hydrogen peroxide rinse.
15774406|NCT04659928|Device|External evacuation device (EED)|Extraoral suction unit will be used and bacterial colony forming units (cfus) will be captured during dental care by placing large format petri dishes containing bacterial culture media in the dental operatory with open lids. Once aerosol capture is complete, petri dishes will be incubated and quantified under BSL-2 safety conditions in the lab.Patient will be given hydrogen peroxide rinse.
15774407|NCT04659928|Drug|Hydrogen Peroxide|Subjects will be given 1.5 % Oral Solution of hydrogen peroxide mouth rinse
15774408|NCT04659915|Drug|Metformin 500 mg Oral Tablets + Prednisone 20mg Tablets|"During one phase of the study: Metformin 500mg Day 1 1-0-0 Day 2 1-0-0 Day 3 1-0-1 Day 4 1-0-1 Day 5 2-0-1 Day 6 2-0-1 Day 7 4-0-0
~In combination with prednisone 20mg: day 1 to day 7 1.5-0-0."
15774409|NCT04659915|Drug|Placebo 500 mg Tablets + Prednisone 20mg Tablets|During another phase of the study: identical looking placebo pills starting day 1 500mg 1-0-0, day 2 500mg 1-0-0, day 3 500mg 1-0-1, day 4 500mg 1-0-1, day 5 500mg 2-0-1. day 6 2-0-1, day 7 4-0-0. In combination with prednisone 20mg: day 1 to day 7 1.5-0-0.
15774410|NCT04659902|Dietary Supplement|Protein form|Protein form and absence or presence of calcium manipulated
15774411|NCT04659889|Diagnostic Test|Blood sampling (venesection)|"All study participants will have a single blood test to analyse the following parameters:
~(i) Serum biochemistry, CRP, Thyroid function and liver enzymes (ii) FBC, d-Dimer, ESR, Blood film (iii) SARS-CoV2 antibody status and serum save (iv) Peripheral blood immunophenotyping."
15774412|NCT04659876|Diagnostic Test|clinical features and laboratory values|Patients' age, gender, comorbidity, ABO and Rh blood groups, APACHE II, SOFA and KDIGO scores when first admitted to the ICU, performing hemogram (WBC, neutrophil, lymphocyte, neutrophil / lymphocyte ratio, hemoglobin, hematocrit, platelet count), blood gas information (pH, PO2, PCO2, HCO3, lactate), coagulation parameters PTZ and D-dimer, blood biochemistry results (CRP, LDH, CK, urea, creatinine, ALT, AST, total bilirubin, direct bilirubin and indirect bilirubin), procalcitonin and ferritin levels will be recorded. In addition, the number of days spent in the ICU and whether mortality develops or not will be recorded.
15774415|NCT04659850|Other|low fat, low AGE milkshake|low fat, low AGE milkshake given after an overnight fast
15774416|NCT04659850|Other|low fat, high AGE milkshake|low fat, high AGE milkshake given after an overnight fast
15774417|NCT04659850|Other|high fat, low AGE|high fat, low AGE milkshake given after an overnight fast
15774418|NCT04659850|Other|high fat, high AGE milkshake|high fat, high AGE milkshake given after an overnight fast
15774419|NCT04659837|Behavioral|No-Added-Sugar Diet|All participants received a no-added-sugar dietary intervention and followed the diet during the course of the study.
15774420|NCT04659811|Drug|Pembrolizumab|200mg given intravenously (IV) on day 1 (to -1) of radiation and then every 3 weeks until progression or unacceptable toxicity
15774421|NCT04659811|Procedure|Stereotactic Radiosurgery|Given in (a) single session treatment with margin dose of 15-20 Gy to the target for a maximum target volume of 8 cc or (b) five consecutive business days treatment to total dose of 25-30 Gy to the target for a maximum target volume of 20 cc when the target volume exceeds 8 cc or the target is in proximity to critical structures
15774422|NCT04659785|Drug|Fluzoparib|Take Fluzoparib orally（either at 50,100mg bid）until disease progression or appearance of unbearable toxicity
15774423|NCT04659785|Drug|Apatinib|Take apatinib orally (either at 375mg、500mg、750mg qd）until disease progression or appearance of unbearable toxicity
15774424|NCT04659772|Drug|Clazakizumab|The patients will be given a single intravenous dose of clazakizumab 25mg. Patients who fail to achieve the expected decrease in inflammatory markers following the first dose within 48 hours will have the day 1 dose repeated (clazakizumab 25 mg) on or before day 3. Clazakizumab will be administered by intravenous infusion over 30 minutes.
15774425|NCT04659772|Drug|Placebo|The patients will be given a single intravenous dose of placebo (normal saline, no active drug). Placebo will be administered by intravenous infusion over 30 minutes.
15774426|NCT04659759|Other|COVID-19 exposure|COVID-19 exposure during pregnancy
15774427|NCT04659759|Biological|COVID-19 vaccine|Receipt of any COVID-19 vaccine
15774428|NCT04659746|Device|MejoraCare|mHealth solution to support remote monitoring of symptoms and patient empowerment through education.
15774429|NCT04659733|Drug|Anlotinib hydrochloride|Anlotinib are divided into 3 dosage levels, including 8mg, 10mg, 12mg; Oral administration of anlotinib was given, qd, D1-D14; taken on an empty stomach, Every 3 weeks is a cycle, a total of 2 cycles; Starting from the first level of anlotinib, the dose will be ramped up in sequence.
15774430|NCT04659720|Device|Hydrolic lifter device|evaluation of implant stability after closed sinus lifting by hydraulic lift technique using hydraulic lifter device
15774431|NCT04659720|Behavioral|Patient satisfaction evalution using hydraulic lifter device|patients satisfaction will be evaluated numerically after using hydraulic lift technique by hydraulic lifter device for closed sinus lifting in posterior edentulous maxilla
15774432|NCT04659707|Drug|Hyperpolarized Xe129|Subjects will inhale up to 4 doses of hyperpolarized Xenon gas in order to image pulmonary function.
15774433|NCT04659694|Other|Wellness programme provided by Oomph! Wellness company|The Oomph! wellness programme empowers older adults to lead a full life for life. It focuses on building an individual-centred programme that consists of a varied exercise and activity plans including days out. All of these, aims in improving the physical and psychosocial wellness in older adults. This intervention is a three day training session for care home staff to understand and learn how to facilitate care activities within their care home.
15774434|NCT04659681|Diagnostic Test|PVI Guided fluid management during surgery for (PVI<12) colloid bolus will be given .|PVI probe attached to finger in PVI Group
15774435|NCT04659681|Diagnostic Test|CVP Guided Fluid management during surgery for CVP<10 cms H2O colloid bolus will be given|Placement of central venous catheter
15774436|NCT04659668|Device|MMG-23-04-2019|"The dermal filler MMG-23-04-2019 is applied to the female intimate area (intramucosal administration) of vaginal vestibule, vaginal walls, clitoris, G spot."
15774437|NCT04659655|Procedure|automated annular suturing|RAM® Automated Suturing Technology. The RAM® DEVICE and SEW-EASY® DEVICE are automated suturing devices indicated for use in the approximation of soft tissue and prosthetic materials when used in conjunction with RAM® COR-SUTURE® QUICK LOAD® surgical suture. Devices will be used for the approximation of respective replacement valves during surgical aortic or mitral valve replacement as described in the study protocol. Cases may include use of the RAM® RING/RAM® RACK devices for suture management and the Aortic Root Retractor (ARR) with delivery device.
15774438|NCT04659642|Drug|Dexmedetomidine Injection [Precedex]|the drug is given 15 minutes before the estimated end of surgery
15774439|NCT04659642|Drug|Fentanyl Citrate Injection|the drug is given 15 minutes before the estimated end of surgery
15774440|NCT04659642|Combination Product|dexmedetomidine and fentanyl|the combination of the two drugs with the same used doses is given 15 minutes before the estimated end of surgery
15774441|NCT04659629|Drug|NL-201|NL-201 is a de novo protein therapeutic.
15774442|NCT04659616|Drug|Cytarabine|Given IV
15774443|NCT04659616|Drug|Daunorubicin|Given IV
15774444|NCT04659616|Drug|Pemigatinib|Given PO
15774445|NCT04659603|Drug|SAR408701|Pharmaceutical form:Concentrated solution for IV Route of administration: IV infusion
15774446|NCT04659603|Drug|Diphenhydramine (pre-medication)|Pharmaceutical form:Tablet Route of administration: oral
15774476|NCT04659330|Behavioral|Online education (BdandMe) for injection technique|patients were referred to the relevant modules on BD and Me™ (for online education)
15774477|NCT04659330|Device|4mm needles|Providing a supply of needles for single use of 4mm insulin injection needle.
15774447|NCT04659577|Behavioral|ICBT for panic and depression|The most known type of CBT for treating PD consists of two major strategies: cognitive restructuring, and interoceptive and structured exposure to bodily sensations that have become associated with panic attacks. As for depression, the most known type of CBT for treating depression consists of two major strategies: cognitive restructuring, the relationship between thoughts and feelings, behavioural activation, sleep hygiene and relaxation. Each ICBT program includes six modules, containing psychoeducation, cognitive restructuring exposures, acceptance, and consolidation of gains and relapse prevention. The online modules include reading passages, worksheets, videos, and homework assignments. After completing each module participants practice related skills and complete homework assignments. The treatment is up to 16 weeks long; participants are encouraged to complete the treatment within this time period, and reminders are sent to monitor their progress
15774448|NCT04659564|Device|User of Dayspring device|The Dayspring™ device is a novel FDA-cleared wearable solution that is portable and easy-to-use sequential compression system.
15774449|NCT04659551|Drug|Epirubicin|Epirubicin 90 mg/mq i.v. every 3 weeks for three cycles
15774450|NCT04659551|Drug|Cyclophosphamide|Cyclophosphamid 600 mg/mq i.v. every 3 weeks for three cycles
15774451|NCT04659551|Drug|Triptorelin|Triptorelin 3.75 mg i.m. every 4 weeks until surgery
15774452|NCT04659551|Drug|Exemestane|Exemestane 25 mg oral continuous daily dose until surgery
15774453|NCT04659551|Drug|Nivolumab|Nivolumab 240 mg flat dose i.v. every two weeks for 8 cycles
15774454|NCT04659538|Device|CAPTIS Embolic Protection device|The CAPTIS Embolic Protection device will be deployed during standard of care TAVR procedure. The device's safety will be assessed up to one month post procedure. The device's technical performance and feasibility to capture and remove debris during the procedure will be evaluated.
15774455|NCT04659525|Drug|Evolocumab|In the intervention arm evolocumab 140 mg subcutaneous every 2 weeks will be administered for 24 weeks to high cardiovascular risk haemodialized statin intolerant patients with hypercholesterolemia
15774456|NCT04659525|Drug|Ezetimibe|Ezetimibe 10 mg daily will be administered for 24 weeks to high cardiovascular risk haemodialized statin intolerant patients with hypercholesterolemia in both the placebo arm (plus placebo) and in the intervention arm (plus evolocumab)
15774457|NCT04659525|Drug|Placebo|In the placebo arm placebo subcutaneous every 2 weeks will be administered for 24 weeks to high cardiovascular risk haemodialized statin intolerant patients with hypercholesterolemia
15774458|NCT04659499|Drug|Nab-paclitaxel in combination with pyrotinib|Nab-paclitaxel I.V. 260mg/m2 every 3 weeks for 12 weeks plus pyrotinib oral 240mg daily for one year
15774459|NCT04659486|Behavioral|Home-based exercise training|Online strength and aerobic home-based exercise training, 3 times per week, for 12 weeks. The exercise program is composed by 2 intensity-levels (starter and advanced).
15774460|NCT04659473|Other|Online survey|This study aims to apply a rapid online survey to determine the Spanish situation in this third wave of the pandemic.
15774461|NCT04659460|Device|Remote Ischemic Conditioning|RIC interventions will be applied to the upper extremity calibrated to induce four, ten-minute cycles of five-minutes-ischemia and five-minutes-perfusion for a total of 20 cumulative minutes of limb ischemia, at a pressure of 250 mmHg.
15774462|NCT04659447|Drug|Platelet-Rich Plasma|36 ml of peripheral blood is extracted from patients, and 4 ml of 3.8% sodium citrate is added for anticoagulation. After centrifugation for 2 times, 4 ml platelet-rich plasma will be prepared.Four semitendinosus tendons and gracilis tendons are prepared.
15774463|NCT04659434|Drug|Sintilimab|"Patients receive sintiliman+R-GemOx three weeks for a cycle, detailed as follows:
~Combination therapy
~Anti-PD-1 antibody (sintilimab): Fixed dose of 200 mg every 3 weeks, d0, intravenous drip (without pretreatment), infusion time: 30 mintutes (no less than 20 mins, no more than 60 mins), for 4 cycles
~R-GemOx: Rituximab 375mg/m2, d1; Gemcitabine 1000mg, d2; Oxaliplatin 100mg/m2, d2; every 3 weeks for a cycle, 4 cycle as protocol specified.
~Monotherapy:
~-Anti-PD-1 antibody (sintilimab): Fixed dose of 200 mg every 3 weeks, d0, intravenous drip (without pretreatment), infusion time: 30 mintutes (no less than 20 mins, no more than 60 mins), for 8 cycles"
15774464|NCT04659421|Drug|combined therapy with rh-ES and CV|"All the patients receive combined therapy with recombinant human endostatin and traditional weekly CV regimen.
~Carboplatin is administered at a dose of 220 mg/m2. Vincristine is administered at a dose of 1.5 mg/m2 (maximum dose 2 mg). Recombinant human endostatin (rh-ES) is administrated at a dose of 15mg daily, for 14 consecutive days every 3 weeks."
15774467|NCT04659395|Other|Emergency nurses|Emergency nurses who are trained for one-day in ultrasound-guided femoral nerve block
15774468|NCT04659382|Drug|Atezolizumab|Atezolizumab combined to standard chemotherapy (XELOX + bevacizumab) and targeted therapy in patients whose tumour has been made immunogenic by radiotherapy (Therasphere) and ICI (atezolizumab).
15774469|NCT04659382|Device|Therasphere|Therasphere injected to patients to promote the release of neoantigens from their tumour and convert it into an immunogenic tumour.
15774470|NCT04659382|Drug|XELOX|standard chemotherapy for first line treament of metastatic CRC (in pMMR and/or MSS patients)
15774471|NCT04659382|Drug|Bevacizumab|standard targeted therapy associated with XELOX for first line treament of metastatic CRC (in pMMR and/or MSS patients)
15774472|NCT04659369|Drug|CMAB819|for injection only
15774473|NCT04659369|Drug|Nivolumab|for injection only
15774474|NCT04659356|Other|Patients admitted in Intensive Care Units|Data will be collected computerized patient records by the clinicians in charge of the patient.
15774475|NCT04659343|Drug|Medical treatment for metastatic renal cell carcinoma|Medical treatment for metastatic renal cell carcinoma with axitinib, cabozantinib, pazopanib, sorafenib, sunitinib, tivozanib, ipilimumab and nivolumab.
15774479|NCT04659317|Drug|Placebo oral tablet|Encapsulated placebo tablets x24, to take po q6 hours as need for pain
15774480|NCT04659304|Drug|Allocetra-OTS|Cell-based therapy comprised of allogeneic non-HLA matched peripheral blood mononuclear cells induced to an early apoptotic state.
15774481|NCT04659278|Dietary Supplement|Endourage 1200 mg OMD ™ Oral Mucosal Drops|The CBD/THC ratio of OMD 1200 is 14:1 and the CBD/Terpene ratio is 1:1. Each ¼ dropper contains 10.2 mg of CBD and 0.7 mg of THC. The total % THC is 0.28%. These ratios indicate that the product will not cause euphoria.
15774482|NCT04659278|Dietary Supplement|Isolate|The isolate formulation contains 0% cannabinoids (CBD 0.00%; CBDa 0.00%; detla 9 THC 0.00%; THCa 0.00%).
15774483|NCT04659278|Other|Placebo|Total CBD = CBD + (CBD-A * 0.877). Total THC = THCA-A * 0.877 + Delta 9 THC, ND = <LOQ, T-Caryophyllene = Trans-Caryophyllene, <LOQ = Less Than Limit of Quantitation, QNS = Quantity Not Sufficient. (%) = Percent, (ppm) = Parts per Million, (ppb) = Parts per Billion, (μg/Kg) = Microgram per Kilogram, (mg/g) = Milligram per Gram, ppm = (μg/g), ppb = (μg/kg),
15774484|NCT04659278|Dietary Supplement|Peppermint Oil, masking flavor|Mentha piperita Leaf /Stem Oil; Physical state: Liquid. Color: Colorless to pale yellow; Characteristic peppermint odor; Not dangerous goods.
15774485|NCT04659265|Other|Suspected diagnosis of a pre-treating physician|Participants receive the information that the pre-treating physician thought the patient is suffering from a medical emergency (no diagnosis), an acute myocardial infarction (correct diagnosis) or a pulmonary embolism (wrong diagnosis)
15774486|NCT04659252|Other|n/a - samples collected along routine care samples only|This is a non-interventional study.
15774487|NCT04659239|Biological|Inactivated SARS-CoV-2 Vaccine (Vero cell)|The inactivated SARS-CoV-2 vaccine (vero cell) was manufactured by IMBCAMS. Each dose of 0.5ml is for per person per time use.
15774488|NCT04659239|Biological|Placebo|The placebo was manufactured by IMBCAMS. Each dose of 0.5ml is for per person per time use.
15774489|NCT04659226|Genetic|Blood sampling for microRNA testing|Blood samples will be collected and analyzed for the microRNA profile by means of microfluidic cards
15774490|NCT04659213|Device|esolution catheter|esolution is a catheter-based therapy designed to displace the esophagus away from the source of ablation energy during ablation of AF and to eliminate the risk of esophageal injury
15774491|NCT04659200|Diagnostic Test|Venous blood was collected for biochemistry testing.|For the measurement of blood tests, 10 ml of blood samples were taken from the right forearm veins with a syringe.
15774493|NCT04659161|Drug|Xanomeline and Trospium Chloride Capsules|Oral xanomeline 50 mg/trospium 20 mg BID on days 1-2 followed by xanomeline 100 mg/trospium 20 mg BID on days 3-7. The dose is increased to xanomeline 125 mg/trospium 30 mg BID on days 8-35 unless the subject is experiencing adverse events from the xanomeline 100 mg/ trospium 20 mg dose. Subjects who were increased to xanomeline 125 mg/trospium 30 mg will have the option to return to xanomeline 100 mg/ trospium 20 mg depending on clinical response and tolerability.
15774494|NCT04659161|Drug|Placebo|Placebo Capsules
15774495|NCT04659148|Procedure|Total proctocolectomy|Total proctocolectomy: surgical removal of the colon, rectum, and anus
15774496|NCT04659122|Biological|AT-100|reconstituted AT-100 for intratracheal administration
15774497|NCT04659109|Drug|glenzocimab|IV administration as a sterile product
15774498|NCT04659109|Drug|Placebo|IV administration
15774499|NCT04659096|Drug|ION537|ION537 will be administered by IV injection.
15774500|NCT04659083|Device|Neurally adjusted ventilatory assist ventilation mode|This technique uses the electrical activity of the diaphragm (Edi) to control respiratory support and the NAVA level as an amplification factor that converts the Edi signal into a proportional pressure.
15774501|NCT04659070|Drug|Experimental : Ezetimibe / Rosuvastatin + Telmisartan|Ezetimibe 10mg / Rosuvastatin 20mg + Telmisartan 80mg PO, Once daily for 8 weeks
15774502|NCT04659070|Drug|Active comparator1 : Ezetimibe / Rosuvastatin|Ezetimibe 10mg / Rosuvastatin 20mg PO, Once daily for 8 weeks
15774503|NCT04659070|Drug|Active comparator2 : Telmisartan|Telmisartan 80mg PO, Once daily for 8 weeks
15774504|NCT04659057|Drug|Nebulized Lidocaine|will receive nebulized lidocaine 2%, 1 mg/kg with a maximum dose of 100 mg (5 ml).
15774505|NCT04659057|Drug|Nebulized dexmedetomidine|will receive nebulized dexmedetomidine (1 μg/kg diluted in 5 ml of saline 0.9%).
15774506|NCT04659057|Drug|Nebulized lidocaine and dexmedetomidine|will receive nebulized lidocaine 2% (0.5 mg/kg) and dexmedetomidine 0.5 μg/kg dexmedetomidine in 5 ml of saline 0.9%.
15774507|NCT04659057|Other|Placebo|will receive nebulized saline 0.9% (5 ml) as control group.
15774508|NCT04659044|Drug|Polatuzumab Vedotin|Given IV
15774509|NCT04659044|Biological|Rituximab|Given IV
15774510|NCT04659044|Biological|Rituximab and Hyaluronidase Human|Given SC
15774511|NCT04659044|Drug|Venetoclax|Given PO
15774512|NCT04659031|Drug|ABC008|ABC008
15774513|NCT04659018|Biological|blood collection|A 5ml blood sample will be taken in a dry tube when the venous line necessary for the general anaesthesia for the colonoscopy is placed.
15774514|NCT04659005|Other|Nurse-led decision counseling|Provide education, tailored information, decision support, and psychosocial support regarding hepatocellular carcinoma screening
15774515|NCT04659005|Other|Usual care|Usual care provided by the hospital, including one-page written education information about diet, medications, and daily exercises
15774516|NCT04658979|Other|Pulmonary tele-rehabilitation|All the participant will by include in a tele-rehabilitation program who will be based on an 12-week intervention including therapeutic education and self-management sessions and training sessions, delivered through a videoconferencing application. All interventions will be under the supervision of a rehabilitation professional from the Pavillon de prévention des maladies cardiovasculaire (PPMC) and modeled according to the recommendations of the ATS/ERS.
15774517|NCT04658966|Other|administration of a self-questionnaire|Women will have to fill in an online self questionnaire on pre-eclampsia
15774518|NCT04658953|Other|Ultrasound guided infiltration|In the patient in prone position, an infiltration guided by ultrasound will be performed in three puncture points (L3-L4, L4-L5 and L5-S1 levels unilaterally). At each level, 1mL of a mixture consisting of 3mL of Linisol 2% (60mg of lidocaine) and 1mL of Depomedrol 40mg / Lidocaine 10mg is injected.
15774519|NCT04658953|Other|Fluoroscopy guided infiltration|In the patient in prone position, an infiltration guided by fluoroscopy will be performed in three puncture points (L3-L4, L4-L5 and L5-S1 levels unilaterally). At each level, 1mL of a mixture consisting of 3mL of Linisol 2% (60mg of lidocaine) and 1mL of Depomedrol 40mg / Lidocaine 10mg is injected.
15774520|NCT04658940|Device|AcQBlate® Force Sensing Ablation System|Percutaneous catheter ablation of the cavotricuspid isthmus
15774521|NCT04658927|Drug|Dexamethasone, 0.4mg|iLUX + dextenza
15774522|NCT04658927|Drug|Prednisone acetate|Prednisolone acetate 1% and iLux
15774523|NCT04658927|Other|Control|iLUX alone.
15774524|NCT04658914|Biological|Rotarix|Live-attenuated oral human rotavirus vaccine (Rotarix) manufactured by GlaxoSmithKline containing at least 10^6 CCID50(median cell culture infective doses) of G1P[8] rotavirus, RIX4414 strain produced in Vero cells. This vaccine is an oral suspension with a single dose (1.5ml) administered using an oral applicator.
15774525|NCT04658914|Biological|Trivalent P2-VP8|Trivalent P2-VP8 subunit vaccine manufactured by SK Chemicals containing 90ug of each VP8 antigen derived from P[4] (DS-1), P[6] (1076), and P[8] (Wa) rotavirus strains fused to the P2 epitope from tetanus toxoid and adsorbed to aluminium hydroxide. A single dose (0.5ml) of this vaccine is administered intramuscularly through injection.
15774526|NCT04658901|Device|ERA-C70,ERA-C30 and ERA-G5|use endovenous radiofrequency closure catheter (ERA-C70,ERA-C30) and endovenous radiofrequency closure generator (ERA-G5) to treat varicose veins of lower extremity
15774527|NCT04658901|Device|ClosureFast™ and ClosureRFG™|use ClosureFast™ and ClosureRFG™ which has the indication of the treatment of varicose veins of lower extremity approved by NMPA
15774528|NCT04658888|Device|Evalyn Self-Sampling Brush|A self-sampling brush to collect cervical cancer cells for screening purposes.
15774529|NCT04658875|Dietary Supplement|Spirulina maxima supplementation|Supplementation with Spirulina maxima (4.5 g/d) in capsules during 12 weeks.
15774530|NCT04658875|Other|Wash-out|2 weeks washout period to each study subject to avoid any possible carryover effect.
15774531|NCT04658875|Other|Placebo supplementation|Supplementation with placebo (4.5 g/d) in capsules during 12 weeks.
15774532|NCT04658875|Other|Isoenergetic diet|All participants will have a personal isoenergetic diet according to their height, weight, body composition and daily physical activity during 26 weeks
15774533|NCT04658875|Other|Systematic physical exercise program|Participants in the systematic physical exercise program groups will exercise for five days a week. The physical activity program will consist of Monday to Friday chair exercises performed during 24 weeks. The approximate exercise duration will be 40 to 50 min. Each exercise session has an initial or warm-up phase (~ 10 min), a main physical conditioning phase (~ 25 min), and a cool-down or relaxation phase (~ 10 min). The physical activities to select have a metabolic equivalent tasks (METs) considered as moderate, between 3.0 and 6.0 METs. Trained personnel will assist older adults to perform the activities, including articular flexibility using elastic bands, postural and proprioception exercises with materials such as rubber balls, wood sticks, and small sandbags. These activities will be selected according to the deterioration and joint stiffness that the participants could present.
15774534|NCT04658862|Biological|Cetrelimab|Participants will receive intravenous Cetrelimab.
15774535|NCT04658862|Drug|TAR-200|Participants will receive intravesical TAR-200.
15774536|NCT04658862|Drug|Cisplatin|Participants will receive cisplatin intravenously.
15774537|NCT04658862|Drug|Gemcitabine|Participants will receive gemcitabine intravenously.
15774538|NCT04658862|Radiation|Conventional radiation therapy|Participants will receive conventional radiation therapy for bladder (64 gy).
15774539|NCT04658862|Radiation|Hypo-fractioned radiation therapy|Participants will receive hypo-fractioned radiation therapy for bladder (55 gy).
15774540|NCT04658849|Drug|Pioglitazone 30 Mg Oral Tablet|"Subjects will self-administer a 30 mg pioglitazone oral tablet daily for 6 months.
~For patient taking a diabetic regimen of gemfibrozil, the dose will be 15 mg daily."
15774541|NCT04658849|Drug|Pioglitazone placebo tablet|Subjects will self-administer an oral placebo tablet containing cellulose daily for 6 months.
15774542|NCT04658836|Drug|Triamcinolone Acetonide 40mg/mL|Intratympanic application of triamcinolone acetonide
15774543|NCT04658823|Drug|HOV-12020 (Palm tocotrienols complex)|Oral Softgel capsule containing mixed tocotrienols and tocopherol with enhanced absorption delivery system; 1 capsule twice daily
15774544|NCT04658823|Drug|Placebo|Oral Softgel capsule containing soybean oil; 1 capsule twice daily
15774545|NCT04658810|Other|Assessment of post-traumatic stress disorder using the Perinatal Post-traumatic Stress Disorder)|Patients identified as women with cytomegalovirus (CMV) seroconversion during pregnancy will be called on the phoned and ask to participate to the study and to answer the Perinatal Post-traumatic Stress Disorder
15774549|NCT04658784|Device|2-0 dioxanone, glycolide and trimethylene carbonate|delayed absorbable, monofilament barbed suture
15774550|NCT04658784|Device|2-0 polydioxanone|delayed absorbable, monofilament non-barbed suture
15774551|NCT04658771|Device|MR-HIFU treatment|"MR-HIFU is an innovative technology that allows for non-invasive thermal ablation of tissues and tumors by integrating an external high intensity focused ultrasound (HIFU) transducer with a conventional MRI scanner.
~The focused ultrasound transducer is placed outside of the body and generates and focuses acoustic energy to heat tumors or other pre-defined focal regions of tissues inside the body. Because the acoustic energy is precisely focused over tiny areas of tissue, potential thermal injury to surrounding tissues is minimal. Cell death inside the selected treatment area occurs via coagulative necrosis while avoiding injury to intervening and adjacent tissues."
15774576|NCT04658537|Radiation|Radiation Therapy|Cancer treatment that uses high doses of radiation to kill cancer cells and shrink tumours
15774552|NCT04658745|Device|Intermittent theta burst stimulation|iTBS (20 trains of ten bursts at eight-second intervals, 600 stimuli, 200-second per session) will be delivered to the ipsilesional hemisphere in stroke patients, by using a butterfly shape coil.
15774553|NCT04658745|Behavioral|Mirror Therapy|Participants will practice the movements with the non-affected hand and try moving the affected arm at the same time to synchronize with the non-affected hand (illusion on the mirror). The movement practice will involve 5 table-top tasks and the participant will be instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session, lasting for 20 minutes.
15774554|NCT04658745|Device|Sham intermittent theta burst stimulation|iTBS (20 trains of ten bursts at eight-second intervals, 600 stimuli, 200-second per session) will be delivered to the ipsilesional hemisphere in stroke patients. However, a sham coil will be used, which is not associated with any stimulation effect on the brain.
15774555|NCT04658745|Behavioral|Sham mirror Therapy|In sham mirror therapy, the mirror will be covered. Participants will practice the movements with the non-affected hand and try moving the affected arm at the same time to move the non-affected hand. The participants cannot receive mirror visual feedback of the paretic upper extremity movement during the therapy. Same as mirror therapy, the movement practice will involve 5 table-top tasks and the participant will be instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session, lasting for 20 minutes.
15774556|NCT04658732|Drug|Administration of Alprazolam , Gabapentin , Dexmedetomidine|Patients will be allocated into one of the 3 groups: Alprazolam (A group), Gabapentin (G group) and Dexmedetomidine (D group) as control group. Alprazolam group (n=15): patients in this group will receive 0.25 mg Alprazolam (2 tablets of Xanax 0.125 mg manufactured by Pfizer). Gabapentin group (n=15): patients in this group will receive 600mg Gabapentin (2 capsules of Neurontin 300 mg manufactured by Pfizer).Control group (n=15): patients in this group will receive 2 tablets of multivitamin (Vitamax manufactured by GlaxoSmithKline S.A.E) as placebo to ensure blindness of the study. The study drug will be received 120 minutes before the operation.
15774557|NCT04658719|Device|Camstent Coated Catheter|The patented 'M4D coating' is applied to inner and outer surfaces using a 'dip/dry' process before sterilisation, creating a safe, inert, and long-lasting finish. The coating reduces friction of the catheter surface, enhancing patient comfort on insertion and withdrawal. It also incorporates the materials which virtually preclude biofilm formation. The coating doesn't elute antibacterial agents or toxins, avoiding the build-up of dead bacteria on the device surface and retaining effectiveness throughout extended use (NB. Effectiveness is not lost because of leaching away of an active antimicrobial agent). Finally, the absence of anti-bacterial moieties means that the healthy microbial flora is not disturbed.
15774558|NCT04658719|Device|Standard Care|Uncoated Foley Catheter
15774559|NCT04658706|Other|A supervised exercise program|is a 12-week exercise program supervised by specially trained instructors combining moderate to high intensity aerobic and strength exercises (three 1 hour sessions a week).
15774560|NCT04658706|Other|exercise prescription|they will receive a prescription concerning healthy lifestyles and a personalized exercise plan
15774561|NCT04658693|Device|Multi contact electrode implant|See arm description
15774562|NCT04658680|Drug|BCG vaccination at first health facility contact|"Intradermal injection at first health facility contact: 0.05 ml dose Mycobacterium bovis BCG live attenuated vaccine in the left deltoid region.
~The strain supplied by the national vaccination programme is provided through UNICEF. Different strains are used interchangeably. The additional BCG vaccines provided through this study will be procured by the Bandim Health Project. Vaccines will be from the WHO list of prequalified vaccines and the same strain will be used in intervention and control health centres."
15774563|NCT04658667|Biological|IHV01|IHV01 consists of the Full-Length Single Chain (FLSC) gp120-CD4 chimera subunit HIV-1 vaccine formulated in aluminum phosphate adjuvant. It is encoded by a synthetic gene, which contains a human codon-optimized HIV (BaL) gp120 sequence followed by human CD4D1D2, with a flexible 20-amino acid linker.
15774564|NCT04658667|Biological|A244|A244 consists of the gp120 envelope glycoprotein HIV-1 subtype CRF_01AE A244 derived from the CM244 CRF_01AE. The A244 gp120 envelope has an 11 amino N-terminal deletion, similar to the A244 protein used in AIDSVAX B/E. The aluminum hydroxide fluid gel (AHFG) adjuvant that is mixed with A244 consists of Rehydragel HPA that is diluted with sterile water for injection to a concentration of 5 + /- 1mg/mL.
15774565|NCT04658667|Biological|ALFQ|ALFQ (Army Liposomal Formulation) is a liposomal adjuvant containing a synthetic monophosphoryl lipid A (MPLA) with the addition of QS-21.
15774566|NCT04658667|Other|Placebo|Saline (sodium chloride for injection USP, 0.9%) will be used as placebo.
15774567|NCT04658654|Drug|Roflumilast|chronic intervention (24 weeks): roflumilast capsule
15774568|NCT04658654|Drug|Placebo oral tablet|Pill with inactive ingredients to mimic same appearance of roflumilast capsule
15774569|NCT04658641|Device|Boston Scientific: Study tool computer|Compare clinical outcome measurements of complex pulse shapes to standard clinical pulse shape
15774570|NCT04658615|Procedure|Non-surgical periodontal therapy|A single 1-hour session of full-mouth debridement with an ultrasonic device under local anesthesia
15774571|NCT04658602|Procedure|Preformed stainless steal crown cemented by glass ionomer lutting cement (Ketac cem,3M Espe)|Covering the affected molar with preformed metal crown cemented by glass ionomer lutting cement
15774572|NCT04658589|Procedure|Laparoscopic versus open distal gastrectomy|Laparoscopic versus open distal gastrectomy after neoadjuvant chemotherapy for locally advanced gastric cancer
15774573|NCT04658563|Other|High Density Exercise Training Program - Yoga|A total of 8 weeks will be applied in our study, each session of the high-density yoga program will be started with 10 minute pranayama (breath) exercises as it is in classical yoga as a preliminary preparation for the participation of individuals; the program will be completed by applying 10-20 minutes warming-stretching movements, 40 minutes surya namaskar (SN) sets, 20-30 minutes dynamic yoga asanas and 10 minutes savasana. Participants will be encouraged to study the perceived difficulty levels between 14 and 17 using the Borg scale during the sessions
15774574|NCT04658550|Other|Remote Behaviour Modification Program|The standard of care behaviour modification program for weight loss will be offered virtually due to the COVID-19 pandemic (prospective).
15774575|NCT04658550|Other|In Person Behaviour Modification Program|The standard of care behaviour modification program for weight loss was offered in person prior to the COVID-19 pandemic (retrospective).
15774578|NCT04658511|Device|Ultrasound|On the spot, during the pre-op clinic visit, an ultrasound exam will be done by the PI trying to visualize the arcade of Struthers
15774579|NCT04658498|Other|Procedure: Usual Care (UC)|Intermittent spontaneous breathing periods
15774580|NCT04658498|Other|Procedure: UC + HI-IMT|UC + Supervised daily sessions of training including 4 sets of 6-10 full vital capacity breaths against an external load using a tapered flow resistive device (POWERbreathe KH2, HaB International, UK). The maximum tolerable resistance allowing patients to inhale at least 70% of their inspiratory vital capacity will be chosen and progressively increased throughout the training period.
15774581|NCT04658498|Other|Procedure: UC + LI-IMT (sham IMT)|UC + superrvised daily sessions of training including 4 sets of 6-10 breaths at the lowest external imposable load with the tapered flow resistive device (POWERbreathe KH2, HaB International, UK) (i.e. 3 cmH2O).
15774582|NCT04658485|Device|Active tDCS|Using the 2-channel neuro-stimulator Sooma tDCS equipment we provide 20 minutes of 2 mA anodal stimulation of the primary motor cortex (M1) with the cathode located over the right primary somatosensory cortex (S1).
15774583|NCT04658485|Device|Sham tDCS|Using the 2-channel neuro-stimulator Sooma tDCS equipment we provide a sham stimulation with the anode place over the primary motor cortex (M1) and cathode located over the right primary somatosensory cortex (S1). The sham stimulation consists of 30 seconds of stimulation ramping up to a maximum of 2 mA, then 19 minutes of the device providing no stimulation and then ramping down from 2 mA intensity to 0 in the last 30 seconds. This configuration is designed to mimic the sensory experience of active tDCS.
15774584|NCT04658472|Drug|BIVV020|Pharmaceutical form:Solution for Injection
15774585|NCT04658459|Procedure|Proximal Interphalangeal Joint Arthroplasty with the Tactys Prosthesis|
15774586|NCT04658446|Device|Augmented Reality-Assisted Indirect Bonding|Virtual Orthodontic attachments are overlaid on top of the patient's teeth using an augmented-reality headset to guide the bracket positioning procedure.
15774587|NCT04658446|Device|Digitally-Asssited Indirect Bonding|3D printed models with precise brackets positioned as virtually pre-planned. To aid in the transfer of the planned bracket positions to the patient's physical teeth.
15774588|NCT04658433|Dietary Supplement|300 mg of omega3-FA|The participant will receive 1,000 mg of wild salmon and fish oil complex once daily, which contains 300 mg of omega3-FA.
15774589|NCT04658420|Drug|Ketamine Hydrochloride|Individuals in the ketamine group will receive ketamine 0.5 mg/kg infused over 40 minutes
15774590|NCT04658420|Other|Music|"A playlist by composer Nils Frahm will be played for 60 minutes. The music is instrumental, relaxing and subjectively thought to be uplifting by patients who have listened to the music during ketamine infusions performed previously by the PI for treatment of resistant depression. Music can be previewed at the link below:
~https://open.spotify.com/playlist/37i9dQZF1DWVbGPBkXJYHF"
15774591|NCT04658394|Other|Reminiscence therapy|Intervention group will receive two RT sessions per week for 13 weeks. RT sessions will last approximately 50 minutes and will be developed according to the following structure: · Welcome to the patient and reality orientation therapy (7 minutes) · Conducting the main activity of reminiscence (40 minutes) · Closure, thank you for the participation and farewell until the next session (3 minutes) Reminiscence therapy sessions will have an individual format and will be conducted by a therapist previously trained in the protocol and the principles of RT. The Reminiscence activities of each session will be carried out following the protocol proposed in the Book of the Past and the Present.
15774592|NCT04658381|Genetic|Genetic analysis|Patient exome sequencing will be performed by Illumina technology on the NextSeq 550 sequencer. Briefly, the exons of the genes are selected by capture and are amplified by PCR simultaneously, in a single reaction, and then sequenced by Illumina technology. The analysis will only concern genes involved in albinism and in genetic pathologies associated with fovea plana.
15774593|NCT04658381|Procedure|Ophthalmologic exam|Standard ophthalmologic assessment (measurement of visual acuity, measurement of intraocular pressure, slit lamp examination), OCT-B scan, OCT-Angiography, Adaptive optics
15774594|NCT04658368|Procedure|Primary TMR|TMR procedure as part of the primary major limb amputation surgery
15774595|NCT04658368|Procedure|Secondary TMR|TMR procedure subsequent to major limb amputation surgery
15774596|NCT04658355|Other|Chlorhexidine Gluconate|4% Chlorhexidine Gluconate vaginal cleansing solution as a surgical preparation.
15774597|NCT04658355|Other|Povidone-iodine|10% povidone-iodine vaginal cleansing solution as a surgical preparation.
15774598|NCT04658342|Diagnostic Test|Videofluoroscopic imaging (VFSS) with high-resolution manometry (HRM)|"The Videofluoroscopic Imaging (VFSS) is done by inserting a small catheter into the nose and down the throat. The catheter is approximately .4 millimeters in diameter. A trained speech-language pathologist will insert the catheter after applying numbing medicine, or topical anesthetic, inside the nose.
~The high-resolution manometry (HRM) is a swallowing pressure test done at the same time as the VFSS. The HRM will measure how strong the throat muscle squeeze the liquids and foods that a person swallows.
~The VFSS and HRM will occur before surgery, about one month after surgery and three months after the completion of the radiation treatment."
15774599|NCT04658329|Drug|Antiretroviral|Study the response to antiretroviral treatment (clinical, immuno-virological) and contribute to the identification of the antiretroviral strategies and combinations most suited to the particularities of the infection.
15774600|NCT04658316|Behavioral|Iowa Oral Performance Instrument|Use Iowa Oral Performance Instrument to measure tongue pressure and swallowing tongue pressure
15774601|NCT04658303|Other|Pimonidazole|Pimonidazole is not used with therapeutic intent, and has a non-hazardous designation. It has been widely used for in-vivo evaluation of intratumor hypoxia, and patients will take PO pimonidazole before the scheduled biopsy. Patients receive an oral dose of pimonidazole, a safe chemical tracer up to 24 hours prior to biopsy. Pimonidazole allows for true hypoxia staining; pimonidazole binds hypoxic proteins covalently, creating an antigen that facilitates the imaging, flow cytometry, and scRNA-seq experiments proposed. Pimonidazole has been previously used in patients and is safe and well tolerated, without anticipated adverse events.
15774604|NCT04658264|Dietary Supplement|Wheat-Barley Composite flour|A combination of wheat and barley flour with 0.5% food grade xanthan gum as replacement for lost gluten, tested for sensory properties, nutrient profile, and rheology
15774605|NCT04658251|Genetic|Blood and/or skin biopsy|Blood and/or skin biopsy will be withdrawn, for RNA extraction in order to test the effect of the variant on splicing.
15774606|NCT04658238|Other|Ocular microbiome|Taxonomical and functional characterization of the ocular microbiome
15774607|NCT04658238|Other|Ocular immune system|Functional characterization of the tear fluid proteome, histology of conjunctival tissue and molecular assays
15774608|NCT04658225|Procedure|0.12% chlorhexidine|the patients were randomly allocated into two groups of 15 individuals to rinse with antimicrobials twice a day for a period of four weeks. Group A, received 0.12% chlorhexidine antimicrobian in a vial previously identified as solution 1 and group B, received saline solution identified as solution 2.
15774609|NCT04658212|Procedure|3D LCBDE|three-dimensional (3D) video system for LCBDE (laparoscopic cholecystectomy and laparoscopic common bile duct exploration )
15774610|NCT04658212|Procedure|ERCP|Endoscopic retrograde cholangiopancreatography (ERCP)
15774611|NCT04658199|Drug|UCB0107 (bepranemab)|UCB0107 (bepranemab) will be administered in a predefined dosage. Pharmaceutical Form: Solution for infusion Route of Administration: Intravenous
15774614|NCT04658173|Drug|remimazolam-alfentanil combination|Group remimazolam-alfentanil combination received 10 µg/kg alfentanil and 0.3mg/kg remimazolam over 30 seconds, followed by an infusion of remimazolam at 0.2 to 1 mg/kg/hr and alfentanil at 0 to 1ug/kg/min. In case of the sudden patient movement, and difficulty in maneuvering the endoscope, remimazolam 0.1mg/kg was used in the form of bolus, as rescue drugs, and alfentanil 5ug/kg when additional analgesia is needed
15774615|NCT04658173|Drug|propofol-alfentanil combination|Group propofol-alfentanil combination received 10 µg/kg alfentanil and 1 mg/kg propofol over 30 seconds followed by an infusion of propofol at 2 to 6 mg/kg/hr. In case of the sudden patient movement, and difficulty in maneuvering the endoscope, propofol 0.5 mg/kg was used in the form of bolus, as rescue drugs，and alfentanil 5ug/kg when additional analgesia is needed
15774616|NCT04658160|Behavioral|Longitudinal Tracking and Intervention Platform for Medicare Advantage Patients|access to/use of the tracking platform
15774617|NCT04658147|Drug|Nivolumab|Nivolumab 480mg will be administered as a 30 minute IV infusion (-/+15min) at cycle 1 day 1 and at cycle 2 day 1 (28 days) then every month for up to 12 months. Intravenous administration of Nivolumab (480 mg) will occur on Cycle 1 and 2 of the study then every 28 days up to a year. Nivolumab will be administered on Day 1 of each cycle for 10 doses/ months (whichever occurs first) for adjuvant.
15774618|NCT04658147|Drug|Relatlimab|Patients will receive 960 mg Relatlimab intravenously (-/+15min) on cycle 1 day 1 and at cycle 2 day 1 (every 28 days) for up to 1 year co-administered with Nivolumab.
15774619|NCT04658134|Dietary Supplement|Glycine|Oral glycine tablets (100 mg/kg/day) in divided doses
15774620|NCT04658095|Device|OMNI® Surgical System|Ab-interno canaloplasty (360 degrees) and up to 360 degrees trabeculotomy using the OMNI Surgical System
15774621|NCT04658095|Device|iStent inject|Ab-interno implantation of iStent inject (2 microstents)
15774622|NCT04658095|Device|OMNI® Surgical System|Ab-interno canaloplasty (360 degrees) using the OMNI Surgical System
15774623|NCT04658082|Device|H.G.R (GWave) non-invasive glucometer|Glucose tolerance test
15774624|NCT04658069|Other|no specific interventions|no specific interventions
15774625|NCT04658043|Other|Intervention on socioemotional functioning|"A culturally sensitive intervention based on the train the trainer (or coach the coach) model for enhancing the social adaptive functioning of young children (aged 3-6) with ASD in China, via providing training for parents"
15774626|NCT04658030|Device|VR 360 video surgery preparation|Preparing children on the surgery by a virtual reality 360 degrees video tour from the pediatric ward to the surgery room. In this video all information is given necessary for the surgery. This takes a maximum of 30 minutes and will be performed 1 time.
15774627|NCT04658030|Other|Care as usual|Preparing the children for surgery with the care as usual. A booklet that can be viewed by the children and parents at home.
15774628|NCT04658017|Device|GARNET device|Use of new filter in conjunction with standard of care dialysis.
15774629|NCT04658004|Drug|NKG2D CAR T-cells|Each subject receive NKG2D CAR T-cells by intravenous infusion
15774633|NCT04657978|Procedure|Substrate guided left atrial ablation|Ablation therapy targeting areas of low voltage, which may include encirclement, homogenization or targeting of abnormal electrograms and anchored to a non-conducting structure if the region is in close proximity or likely to create an isthmus for arrhythmias.
15774634|NCT04657965|Drug|LMP1 CAR T-cells|Each subject receive LMP1 CAR T-cells by intravenous infusion
15774635|NCT04657952|Procedure|Sphenopalatine Ganglion Block|Sphenopalatine Ganglion Block will be performed by a transnasal approach. Few drops of lidocaine 2% will be instilled into both anterior nares. Then a cotton-tipped applicator soaked in 4% lignocaine & adrenaline (1 to 200000 will be passed through both the nares and the end of the applicator tip will be positioned just superior to the middle turbinate and anterior to the pterygopalatine fossa and sphenopalatine ganglion for 5 min with the patient in the supine position.
15774636|NCT04657952|Drug|Medical Treatment|Patients will receive paracetamol 1 gm 6 hours daily intravenously for a day. If adequate pain relief will not be achieved, intravenous diclofenac 75 mg twice daily will be added.
15774637|NCT04657939|Drug|Liraglutide|Liraglutide 0.6mg once daily by subcutaneous injection escalated to 1.2mg after 2 weeks.
15774638|NCT04657939|Drug|Pioglitazone|Pioglitazone 15mg once daily tablets taken orally escalated to 30mg after 2 weeks then escalated to 45mg after another 2 weeks.
15774639|NCT04657926|Drug|APPA|APPA, an oral combination of two isomers: 4-hydroxy-3-methoxyacetophenone (4H3MA) & 2-hydroxy-4-methoxyacetophenone (2H4MA).
15774640|NCT04657926|Drug|Placebo|Placebo capsules
15774641|NCT04657913|Other|cold water spray application|It will be sprayed into the mouth of patients every hour.
15774642|NCT04657913|Other|cold saline spray application|It will be sprayed into the mouth of patients every hour.
15774647|NCT04657861|Drug|APRIL CAR-T cells|Each subject receive APRIL CAR T-cells by intravenous infusion
15774648|NCT04657848|Procedure|proximal gastrectomy combined with Cheng's Giraffe reconstruction|proximal gastrectomy combined with gastric tube interposition esophagogastrostomy with reconstruction of His angle and fundus (Cheng's Giraffe reconstruction)
15774649|NCT04657835|Device|cardiac Magnetic Resonance Imaging (MRI)|Cardiac magnetic resonance imaging (MRI) will be realized before Coronary Artery Bypass Grafting for assess atrial cardiomyopathy.
15774650|NCT04657835|Biological|Blood sample|Blood sample will be realized (4 tubes of 4ml blood, 16ml in total) before Coronary Artery Bypass Grafting.
15774651|NCT04657835|Procedure|Cardiac muscle biopsy|Cardiac muscle biopsy will be realized during Coronary Artery Bypass Grafting.
15774652|NCT04657835|Device|Holter-electrocardiogram (ECG)|Holter-electrocardiogram (ECG) will be realized 1 year after Coronary Artery Bypass Graftin during 3 days to diagnose the occurrence of atrial fibrillation.
15774653|NCT04657835|Other|medical examination|medical examination will be realized 1 year after Coronary Artery Bypass Graftin. Theses datas will collected: events during the follow-up year and evaluation of the Holter-electrocardiogram result.
15774654|NCT04657822|Drug|Crizanlizumab|Concentrate for solution for infusion for Intravenous use
15774657|NCT04657796|Device|High Flow Nasal Cannula|use of high flow nasal cannula as a weaning mode from invasive mechanical ventilation to deliver oxygen
15774658|NCT04657770|Device|Telerehabilitation|The telerehabilitation system will deliver rehabilitation treatment sessions via a secured internet-connected computer. A major component of the system is the use of games to promote therapeutically relevant movements. The subject will perform daily assigned remote-based telerehabilitation games and exercises and 5 minutes of stroke education, all guided by the telerehabilitation system. During some of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed.
15774659|NCT04657757|Other|Intraoral apparatus|Eight platelets with different material composition and surface properties are fastened in a holder (carrier rondell) with 15 mm diameter and inserted into the braces. Braces are to be worn for 28 hours in the oral cavity except for meals and oral hygiene procedures. Platelets then are removed and analyzed. After a first course the braces are to be cleaned in chlorhexidine solution in an ultrasonic bath; followed by a second identical course (Braces to be worn for 28 hours in the oral cavity except for meals and oral hygiene procedures).
15774660|NCT04657744|Drug|Sphingomod|1 capsule contains 0.5 mg Fingolimod
15774661|NCT04657744|Drug|Gilenya|1 capsule contains 0.5 mg Fingolimod
15774662|NCT04657718|Device|KODEX-EPD system|Cardiac pacing leads implantation for PM, ICD, CRT, HBP and LBBP
15774663|NCT04657705|Procedure|High power ablation|High power ablation parameters (50-55 W)
15774664|NCT04657705|Procedure|Standard ablation power|Standard ablation power parameters (40-45 W)
15774665|NCT04657692|Procedure|Anesthesia; general or regional|General anesthesia: general anesthesia with endotracheal tube Regional anesthesia: spinal anesthesia, epidural anesthesia, combined spinal epidural anesthesia
15774666|NCT04657679|Drug|Ribociclib|Patients will receive ribociclib 600 mg oral (PO) daily for 21 consecutive days of 28-day cycles and endocrine therapy with either letrozole or fulvestrant. Fulvestrant 500 mg intramuscular (IM) will be administered on days 1, 15, 29 of cycle one, and then monthly. Letrozole 2.5 mg oral daily continuously. If premenopausal women have not undergone bilateral salpingo- oophorectomy, they will receive goserelin for ovarian suppression (3.8 mg subcutaneous every 28 days) in combination with fulvestrant or letrozole and ribociclib.
15774667|NCT04657666|Drug|Nabiximols|oromucosal spray
15774668|NCT04657666|Drug|Placebo|oromucosal spray
15774669|NCT04657653|Procedure|core decompression|:The procedure was performed under general anesthesia with the aid of image intensifier. All patients were positioned in supine position on a fracture table. The core decompression was performed using the direct lateral approach with 2 cm skin incision. A fluoroscope guided large single drill with 8 mm diameter over a guide wire was used to remove the necrotic tissues from the femur head through the lateral cortex distal to trochanteric tubercle. After the removal of the core necrotic bone, the track was filled with 5 ml synthetic bone paste substitute (tricalcium phosphate) and an intraoperative fluoroscope was used to confirm the adequacy of the decompression and grafting.
15774670|NCT04657640|Dietary Supplement|Iron and folic acid (IFA)|Weekly regimen of one tablet containing Iron (60mg) and Folic Acid (2800 μg) for 3 months intermittently
15774671|NCT04657640|Dietary Supplement|Multiple Micronutrient Supplements (MMS) and loading dose of Iron and Folic Acid (IFA)|"Daily regimen of MMS for 3 months intermittently. MMS is the United Nations International Multiple Micronutrient Antenatal Preparation (UNIMMAP) tablet containing fifteen micronutrients including iron (30mg), folic acid (400 mcg), Vit A, Retinol (800 RE), vit D (200 IU), vit E (10 mg), vit C (70 mg), vit B1 (1.4 mg), vit B2 (1.4 mg), vit B6 (1.9 mg), vit B12 (2.6 mcg), niacin (18 mg), zinc (15 mg), copper (2 mg), iodine (150 mcg), selenium (65 mcg).
~For the first 5 weeks of the study, participants will also receive weekly regimen of one tablet containing Iron (60mg) and Folic Acid (2800 μg) as a loading dose, in addition to daily MMS."
15774672|NCT04657627|Behavioral|PACE plus calorie labelling information|The intervention group will be exposed to PACE plus calorie labelling information via Instagram and Twitter social media posts every day for 13 weeks.
15774673|NCT04657627|Behavioral|Calorie-only labelling information|The comparator group will be exposed to calorie-only labelling information via Instagram and Twitter social media posts every day for 13 weeks.
15774674|NCT04657614|Other|Neutral Alignment|Alignment that is a neutral replicate of the participants prescribed prosthesis.
15774675|NCT04657614|Other|Anterior Alignment|Alignment that is anterior displaced pylon.
15774676|NCT04657614|Other|Posterior Alignment|Alignment that is posteriorly displaced pylon.
15774677|NCT04657601|Device|DiLumen C2 Endolumenal Interventional Platform|Dual balloon accessory to an endoscope and related instruments
15774705|NCT04657302|Drug|Glofitamab|Participants will receive 2.5 mg of IV glofitamab Cycle 1 Day 8, 10 mg at Cycle 1 Day 15, and 30 mg on Day 1 of Cycles 2-12 Q3W (cycle length = 21 days).
15774706|NCT04657302|Drug|Tocilizumab|Participants will receive tocilizumab as needed to manage cytokine release syndrome (CRS).
15844860|NCT04084184|Drug|HGP1812|Dapagliflozin (Forxiga) 10mg
15774678|NCT04657588|Device|myMiracle anal insert|The myMiracle device is a single-use, pre-lubricated, liquid-filled rectal insert with a plastic applicator. The insert is filled with liquid mineral oil. The primary advantage of this new instrument is the fact that the liquid-filled insert will move and adapt as the fluid is transferred throughout the device making it easy to insert/remove and comfortable to wear. The design is intended to adjust to the contours of the individual anatomy to prevent leakage.
15774679|NCT04657588|Other|Care as usual|Care as usual means participants are to continue their usual treatment for FI, like they would if they would not have participated in this study.
15774680|NCT04657575|Procedure|Narcotrend|ECT stimulation within an anaesthesia depth range of 41-64
15774681|NCT04657562|Drug|Tacrolimus|Prevention of rejection in kidney or liver transplant: a standard immunosuppressive therapy according to international protocols.
15774682|NCT04657549|Procedure|Tonsillectomy|Tonsillectomy is done by monopolar electrocautery, bipolar scissors or cold instruments. First the mucosa of the anterior palatinal arch is incised and tonsillar capsule identified, then tonsillar tissue is removed along the capsule. Any bleeding is coagulated either with monopolar or bipolar electrocautery.
15774683|NCT04657549|Procedure|Tonsillotomy|Tonsillotomy is done using monopolar electrosurgery, bipolar scissors or coblator device. Most of the tonsillar tissue is removed, exceeding the removal behind the line between anterior and posterior palatinal arch so that only thin layer of tonsil tissue is left over the tonsillar capsule.
15774684|NCT04657536|Device|high frequency fulguration equipment|All subjects will be carried out with 3 standard protocol TRF treatments to the vulvovaginal tissue using the high frequency fulguration equipment (Shenzhen Peninsula Medical co., Ltd) at 10-day to 15-day intervals. Radiofrequency energy was applied to the vaginal canal through a specialized probe combining monopolar and bipolar treatment modes. Monopolar treatment mode is for 15 minutes. Aim the three indication points A, B and C on the probe to the direction of 12 o'clock in turn. Each area should be treated for about 5 minutes. Rotate the probe clockwise when changing the area for treatment.Bipolar treatment mode is for 10 minutes. Firstly, indication point A is aimed to 12 o'clock for 5-minutes treatment and then the probe is rotated 90°clockwise for another 5-minutes treatment. The power setting will be 35-40w, and the target temperature setting will be 40 to 45℃, titrated to subject tolerance.
15774685|NCT04657536|Drug|promestriene vaginal soft capsules|Promestriene vaginal soft capsules（Zhejiang Anbao Pharmaceutical Co. LTD）will be used 10mg once a day for continuous 20 days.
15774686|NCT04657523|Device|Investigational Liver Fat Quantification Software|All subjects enrolled in this study will undergo two abdominal ultrasound examinations using the investigational Liver Fat Quantification feature on the Philips EPIQ Ultrasound System. In addition, all subjects will also undergo one MRI-PDFF examination according to the clinical standard of care.
15774687|NCT04657510|Other|COVID-19|Patients affected versus not affected by COVID-19, with the same starting condition (proximal femur fracture)
15774688|NCT04657497|Drug|FOY-305|Specified Dosage and Duration of Treatment
15774689|NCT04657497|Drug|Placebo|Specified Dosage and Duration of Treatment
15774690|NCT04657484|Drug|Medium dose prednisolone|Same as arm description
15774691|NCT04657484|Drug|Low dose prednisolone|Same as arm description
15774692|NCT04657471|Other|revised HOME-CoV score|"Educational lectures, posters, and pocket cards showing and explaining the revised HOME-CoV score are communicated to participating Emergency Departments.
~For included patients, the physician-in-charge calculates the revised HOME-CoV. Patients with a score <2 qualified for home treatment. They qualified otherwise for hospitalization. For patients with a score > 4, hospitalization in a unit allowing monitoring of vital parameters is recommended. However, the physician-in-charge can overrule the qualification for home treatment or for hospitalization in case of major medical or social reasons. A justification explaining the cause of overruling is required."
15774693|NCT04657458|Biological|Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment|Intravenous Infusion over 60 minutes
15774694|NCT04657445|Diagnostic Test|visual analogue scale|A visual analog scale (VAS) is a measurement device used to quantify a subjective experience.
15774695|NCT04657432|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|MagVenture MagPro TMS System would be utilized to deliver 3-minute sessions of intermittent theta burst to left dorsolateral prefrontal cortex.
15774696|NCT04657419|Other|survey|"Self-questionnaires will be completed by the participants :
~General health and mental health
~Fatigue
~Burn-Out
~Sleepiness
~Sleep hygiene
~Symptoms of COVID"
15774697|NCT04657406|Drug|ZofinTM|Subjects will receive standard of care plus 1 mL of ZofinTM (OrganicellTM Flow) on day 0, day 4 and day 8, containing 1-5 x 1011 particles/mL.
15774698|NCT04657393|Procedure|mechanical ventilation|change of ventilation frequency
15774699|NCT04657380|Behavioral|PLAN-e-PSY mobile application|"The full version of the application to be evaluated will result from the process of co-design phase of the intervention based on the iterative user-centered design approach, involving representatives of carers, patients and caregivers, to define the content and form of the smartphone application during co-building workshops"
15774700|NCT04657380|Behavioral|Control Group|The first-episode psychosis services participating in the study offer case-management, which will correspond to the treatment as usual in the control group. All the centers are part of the National Transition Network (https://idpsy.org/reseau-transition/centres/). Involvement in this network ensures homogeneity of the usual practices which correspond to the internationally standards. Care delivery is based on intensive treatment during the critical period of psychosis, relying on a wide network
15774701|NCT04657367|Other|Observational study - registry|Observational study - registry
15774702|NCT04657354|Procedure|Assessment|Early surgical assessment
15774703|NCT04657315|Drug|MSC11FCD|"Administration period: Single dose Route of administration: Intratumoral administration Dose: 1x10^7, 3x10^7cells/dose Summary: Administer the investigational drug in the amount of 1x107, 3x107cells per dose into the tumor or the tumor removal site using a syringe during surgery.
~Concomitant drug: 5-Flucytosine (prodrug) Dose: 150mg/kg/day
~Directions:
~Administration period and directions: Administer 150m of 5-Flucytosine per kilogram of body weight every 6 hours for a total of 4 times a day (QID) for a duration of 7 days after surgery.
~Route of administration: Oral administration"
15774704|NCT04657302|Drug|Obinutuzumab|Participants will receive 1000 mg of intravenous (IV) obinutuzumab on Cycle 1 Day 1.
15774850|NCT04656041|Drug|Paclitaxel|Paclitaxel and Carboplatin will be given concurrently with radiation therapy weekly (+/- 1 day).
15774707|NCT04657289|Drug|PDS Implant filled with 100 mg/mL Ranibizumab|"Arm A: Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 36-week intervals
~Arm B: Participants will receive ranibizumab delivered through the PDS implant with 100 mg/mL in the study eye on Day 1 and receive refill-exchanges at fixed 24-week intervals"
15774709|NCT04657250|Behavioral|Smoking cessation + quitline linkage text messages|Smoking cessation text messages will provide behavioral skills and support for quitting smoking. Quitline linkage text messages will include contact information for the quitline, option to be contacted by the quitline and active referral to the quitline upon setting a Quit Date.
15774710|NCT04657250|Behavioral|Passive quitline referral|Single text message with contact information for the Quitline
15774711|NCT04657237|Procedure|Thoracic Paravertebral block|TPVB will be given using high frequency linear U/S transducer, place the U/S ultrasound probe was placed parallel to the vertebral spine at T4, and, T6 level and shifted 2-3 cm laterally to obtain the appropriate visualization. Following the identification of pleura, transverse process and paravertebral space, the needle was inserted in caudocranial direction using in-plane approach. Confirm negative vessel or pleural breach via aspiration then proceed with local anaesthetic 0.25% bupivacaine (20 ml) delivery slowly divided equally at T4and T6; the pleura will be seen to be pushed downward
15774712|NCT04657224|Drug|JNJ-64264681|JNJ-64264681 capsules will be administered orally.
15774713|NCT04657224|Drug|JNJ-67856633|JNJ-67856633 capsules or tablets will be administered orally.
15774714|NCT04657211|Other|prospective observational cohort study|prospective observational cohort study
15774716|NCT04657185|Other|OR PathTrac Feedback Optimization|OR PathTrac (RDB Bioinformatics, Omaha, NE 68154) uses a systematic phenotypic approach leveraging temporal association to monitor 13 anesthesia work area reservoirs proven to be associated with high-risk intraoperative bacterial transmission events and subsequent infection development.
15774717|NCT04657172|Drug|Pilocarpine Ophthalmic|Pilocarpine 1% or 2% ophthalmic solution administered with the Optejet microdose dispenser
15774718|NCT04657172|Drug|Placebo|Vehicle ophthalmic solution administered with the Optejet microdose dispenser
15774719|NCT04657159|Other|Pain rehabilitation program|Effect on health related quality of life och health-care consumption after rehabilitation
15774720|NCT04657146|Other|Biorepository|"Tumor collection (> 1cm3): Intraoperatively
~Peripheral blood collection:
~Intraoperatively (60mL)
~Post-resection (30mL)
~Post- standard of care treatment (30mL)
~Bone marrow aspiration:
~Intraoperatively (10mL)
~Post-resection (5mL)
~Post- standard of care treatment (5mL)"
15774721|NCT04657133|Device|Remote ischemic conditioning|RIC is a non-invasive therapy that performed by an electric autocontrol device with cuff placed on arm. RIC procedures consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on one arm. The procedure will be performed once daily for consecutive 7 days after enrollment.
15774722|NCT04657133|Device|Sham remote ischemic conditioning|Sham RIC will be performed by the same electric autocontrol device with cuff placed on arm. Sham RIC procedures consist of five cycles of 5-min inflation (30 mmHg) and 5-min deflation of cuff on one arm. The procedure will be performed once daily for consecutive 7 days after enrollment.
15774723|NCT04657133|Drug|Standard medication therapy|Standard medication therapy will be performed according to the national and international guidelines.
15774724|NCT04657120|Procedure|YEARS|Patients randomized to the YEARS algorithm will be evaluated according to the YEARS algorithm consisting of three items of the original Wells rule (clinical signs of DVT, hemoptysis and 'PE most likely diagnosis') and a D-dimer test. In patients without any of the three items and a D-dimer level <1.0 μg/mL, and in patients with ≥1 items and a D-dimer level <0.5 μg/mL a PE is excluded without CTPA. In the other patients a standard contrast enhanced CTPA will be performed according to local practice. PE is defined as at least one filling defect in the pulmonary artery tree on CTPA.
15774725|NCT04657120|Procedure|CTPA|Patients randomized to the CTPA management group will undergo a contrast enhanced CTPA to rule out PE according to standard local practice.
15774726|NCT04657107|Drug|S-ketamine|K1 group: pregnant women received 0.2mg/kg S-ketamine, intravenous drip;
15774727|NCT04657107|Other|normal saline|Saline group: pregnant women received saline, intravenous drip
15774728|NCT04657107|Drug|S-ketamine|K2 group: pregnant women received 0.3mg/kg S-ketamine, intravenous drip;
15774729|NCT04657094|Drug|Acalabrutinib|Given PO
15774730|NCT04657081|Drug|Decitabine and Cedazuridine (ASTX727)|Route of administration: oral in the form of a tablet
15774731|NCT04657081|Drug|Venetoclax|Route of administration: oral in the form of a tablet
15774732|NCT04657068|Drug|ART0380|Participants will receive ART0380 by mouth either intermittently (once daily 3 days on, 4 days off or days 2-4 and 9-11) or continuously (once daily each day) in 21 day cycles.
15774733|NCT04657068|Drug|Gemcitabine|Gemcitabine will be administered at a dose of 1000 mg/m^2 on Days 1 and 8 of a 21 day cycle.
15774734|NCT04657055|Device|The AcQBlate® Force Sensing Ablation System|Percutaneous catheter ablation of the cavotricuspid isthmus
15774735|NCT04657042|Diagnostic Test|Magnetic Resonance Imaging|Four-dimensional MRI of torso
15774736|NCT04657029|Behavioral|Treadmill|30 minutes of moderate-high intensity treadmill training.
15774737|NCT04657016|Drug|Tirzepatide|Administered SC
15774738|NCT04657016|Other|Placebo|Administered SC
15774741|NCT04656990|Behavioral|Integrated Intervention|Gross motor and social-emotional integrated intervention
15774742|NCT04656977|Other|VR|The proposed intervention will consist in three weekly sessions of 2h focused, respectively, on: (1) gathering information about the loss and psychoeducation about perinatal grief, and introduction to the virtual environment; (2) through the use of the virtual environment, women will be assisted in the elaboration and acceptation of loss; (3) recreate, using the features of the virtual environment (i.e., a series of different virtual landscapes and symbolic elements personalized to each participant as personal pictures, sounds or videos) a new and positive metaphor representing the woman's future life.
15774743|NCT04656977|Other|TAU|The TAU condition is a homogenous standard program proposed by the CERIF at UQO based on group counseling offered to women and men who experienced a perinatal loss.
15774744|NCT04656964|Drug|remimazolam tosilate|Patients received an initial dose of 0.2mg/kg of remimazolam tosilate(plus repeated 2.5 mg top-ups doses to a total of up to 12.5mg within 15 minutes).
15774745|NCT04656964|Drug|Midazolam|Patients received an initial dose of 0.03mg/kg of midazolam(One additional dose of 0.015 mg / kg midazolam was allowed).
15774746|NCT04656951|Drug|Daratumumab|Daratumumab added to induction regimen of bortezomib, cyclophosphamide and dexamethasone (VCD), to bortezomib and dexamethasone during maintenance and to lenalidomide and dexamethasone at progression/relapse.
15774747|NCT04656938|Behavioral|Pre-frail intervention|Pre-frail partiipants will undergo 4 month intervention consisted of group-based physical exercise and nutritional classes.
15774748|NCT04656925|Behavioral|Contingency management|Reinforcement, or incentives, in exchange for evidence of not drinking alcohol.
15774749|NCT04656912|Procedure|Hyperbaric oxygen therapy|Patients with any symptoms and signs were treated with HBO2. During the first HBO2, initial compression was performed to 2.8 atmospheres absolute (ATA) for 45 min, followed by 2.0 ATA for 60 min. If an additional HBO2 was possible within 24 h, then 2.0 ATA was administered for 90 min. Moreover, if necessary, patients were treated with HBO2, even after 24 h, until all symptoms resolved.
15774750|NCT04656899|Behavioral|Reminders messages to improve adherence.|"If the participant does not take their medicine at the correct time, a light on the smart pill cap begins to flash. If the bottle is not opened within 20 minutes, the Pillsy application sends an SMS text reminder to the participant's phone. If the bottle is not opened within 60 minutes, the participant receives an automated phone call. The participant may also receive brief motivational phrases or craving surveys that can be tailored to participant needs and preferences. Also, based on pre-populated and adjustable craving and withdrawal levels, the participants' provider could be contacted automatically based on the thresholds being crossed. Pillsy also includes a Pillsy Helpers feature in which the patient can name friends and family members who will also receive a text message notification one hour after a missed dose."
15774751|NCT04656886|Drug|Intravenous Infusion|
15774752|NCT04656873|Procedure|Biospecimen Collection|Undergo collection of tissue, blood, urine and stool samples for research
15774753|NCT04656873|Other|Medical Chart Review|Periodic review of medical records for clinical parameters (labs, ICI dosing and frequency, occurrence, timing and type of irAE, irAE management, etc.) along with relevant demographic information (age, sex/gender, race/ethnicity, insurance type, etc.).
15774754|NCT04656873|Other|Questionnaires/Surveys|Periodic self-report questionnaires/surveys for symptom tracking, quality of life, perinatal outcomes, etc.
15774755|NCT04656860|Dietary Supplement|Juice Plus+|Participants will receive encapsulated fruit and vegetable juice concentrates or a placebo for a 24-month period
15774756|NCT04656847|Drug|in daily everyday routine practice|patients with HTN and CAD treated with the the single pill combination bisoprolol/perindopril for 12 weeks in the daily clinical practice Retrospective screening and evaluation of patient's eligibility to inclusion/ exclusion criteria for entering the study allows mitigating a potential risk of deliberative medicine administration within the observational program.
15774757|NCT04656834|Procedure|hand incision closure using monocryl sutures and skin glue|At the end of surgery, the investigator will close the incision using monocryl sutures and skin glue
15774758|NCT04656834|Procedure|hand incision closure using simple nylon sutures|At the end of surgery, the investigator will close the incision using simple nylon sutures
15774759|NCT04656821|Drug|Control Rx|Patients of this group will receive standard treatment for herpes zoster which include acyclovir 800 mg, 5 times daily administered orally within the first 72 hours and analgesics as needed
15774760|NCT04656821|Procedure|Erector Spinae Block|Patients of this group will receive 25 mg bupivacaine 0.5%, plus 8 mg dexamethasone in a total volume of 10 ml (The final concentration of bupivacaine will be 0.25%) to be injected beneath the erector spinae muscle sheath) at the desired level under ultrasonography.
15774761|NCT04656821|Procedure|Thoracic Paravertebral Block|Patients of this group will receive 25 mg bupivacaine 0.5% , plus 8mg dexamethasone in a total volume of 10 ml(The final concentration of bupivacaine will be 0.25%) to be injected in the Paravertebral space at desired level under ultrasonography
15774762|NCT04656808|Behavioral|Guilt Focused Intervention|Psychotherapy, group intervention
15774763|NCT04656808|Behavioral|Cognitive behavioral therapy|Psychotherapy, group intervention
15774764|NCT04656795|Drug|MT-7117|MT-7117
15774765|NCT04656782|Other|Imaging survey|Participation as expert panelist in the imaging survey.
15774766|NCT04656782|Other|Facilitation|Moderation and evaluation of the expert panel's answers. Adoption and moderation of further survey rounds.
15774767|NCT04656769|Procedure|Peridural analgesia|We attempted to evaluate the effectiveness of peridural analgesia through cancer survival and recurrence outcomes.
15774768|NCT04656756|Behavioral|Personalized Care|A clinical and standardized workflow was created for both experimental and control groups. This standardized workflow: consisted of services which included the management of basic medications, routine care regarding the postpartum period, newborn care and health education. After the standardized clinic workflow was formed, a personalized care plan was developed for the experimental group. Each care procedure was shared with the participants in the experimental group. Moreover, all potential alternative care plans were presented to the participants.
15774769|NCT04656743|Procedure|intra-articular injection|The injection will be performed under ultrasound guidance by placing the patient's knee in approximately 90° of flexion with the leg hanging off the side of the bed (left). A high-frequency linear transducer ultrasound probe is placed in the superolateral corner of the patella, directed medially toward the patellofemoral joint space. In the extended leg, from anterior to posterior, the right image shows the quadriceps femoris tendon (QF), suprapatellar fat pad (SF), suprapatellar bursa (SB), prefemoral fat pad (PF), and femur (F). When the knee is flexed to 90°, the size of the suprapatellar bursa image is increased. Using an in-plane approach, the needle will be directed into the suprapatellar joint space, and 20 ml of bupivacaine 0.25% will be injected.
15774847|NCT04656067|Drug|Oxytocin ,Tranexamic acid and Ethamsylate|Is to compare blood loss during elective cesarean section intraoperative and postoperative in cases receiving Oxytocin versus Tranexamic acid and Ethamsylate
15774848|NCT04656054|Procedure|liposuction|liposuction procedure and observation of the hematological changes on the patients
15774770|NCT04656743|Procedure|genicular nerve block|The transducer will be first placed parallel to the long bone shaft and moved up or down to identify the epicondyle of the long bone. The genicular arteries will be identified near the periosteal areas, confirmed by color Doppler ultrasound. Accordingly, genicular nerve block target points should be next to each genicular artery. After using color Doppler to confirm the genicular artery, the needle will be inserted in the plane of the ultrasound probe in the long-axis view. a gentle aspiration will be performed and a 2 mL injection volume will be administered.
15774771|NCT04656730|Drug|Iberogast® and Iberogast® N|Oral intake of the investigation drug 20 drops three times per day (TID) for 14 days,
15774772|NCT04656717|Other|Measure of the total cost of performing next-generation sequencing (NGS)|Resources consumed were collected for each laboratory using a standardized questionnaire. The production costs were calculated for the overall process and resources consumed for each step were identified.
15774773|NCT04656704|Drug|hyaluronidase injected intradermally|Patients will receive 200 units of hyaluronidase injected intradermally to the cutaneous lips on Weeks 0, 4, 8, 12, and 16, and 20
15774774|NCT04656691|Drug|bamlanivimab|Participants that test positive for COVID-19 may be eligible to receive an in-home infusion of bamlanivimab by a registered nurse. This infusion will last approximately 1 hour followed by 1 hour of observation.
15774775|NCT04656678|Device|Cryo-ablation Using DynaCAD / UroNAV preplanning / guidance|Focal ultrasound guided cryoablation using uroNav system Version 4.0 and Dyna CAD software version 5.0.
15774776|NCT04656665|Drug|Aspirin|For patients at high risk of pre-eclampsia, start taking aspirin from 12-20 weeks of pregnancy
15774777|NCT04656652|Drug|DS-1062a|DS-1062a will be administered as an intravenous (IV) infusion on Day 1 of each 3-week cycle
15774778|NCT04656652|Drug|Docetaxel|Docetaxel will be administered as an IV infusion on Day 1 of each 3-week cycle.
15774779|NCT04656626|Behavioral|brief mindfulness based intervention|The 20 minute daily mindfulness sessions for 2 weeks consist of the following guided meditation practices: 1. Bring your attention to a primary object of focus 2. Maintain a moment-moment awareness 3. When your mind naturally drifts into thinking (mind wandering); just notice you are thinking, and then bring your attention back to your object of focus 4. When a strong sensation arises, again, notice the sensation or emotion and return to your breath. 5. As you gain confidence, you may practice maintaining this focus while observing thoughts flowing through your mind or sensations in your body while showing no concern for the content 6. You may even label your thoughts 7. Thank yourself for your efforts and for taking this time.
15774780|NCT04656626|Behavioral|Progressive muscle relaxation|"Control group:
~Control group will be given an mp3 audio recording of a 20-minutes of progressive muscle relaxation will be sent directly as SMS messages and emails to be heard by the participants through their personal device of their choice, such as a smart phone."
15774781|NCT04656613|Biological|Gam-COVID-Vac|the Gam-COVID-Vac is combined 2 -component vector vaccine against the SARS-СoV-2-induced coronavirus infection
15774782|NCT04656613|Other|placebo|Placebo Comparator
15774783|NCT04656600|Drug|Cerezyme® / Imiglucerase|Pharmaceutical form: lyophilisate for solution for infusion Route of administration: intravenous
15774784|NCT04656587|Device|Philips Respironics V60 Non-invasive ventilator, BPAP|Continuous albuterol will be administered through the BPAP circuit.
15774785|NCT04656587|Other|Standard Therapy|Standard status asthmaticus therapy with continuous beta-agonist, steroids and oxygen as needed.
15774786|NCT04656574|Behavioral|Simulation-based training|The simulation training included the activities that midwives should do during the birth and management of vaginal delivery with episiotomy. The students received theoretical training, and to reinforce it, they were asked to mold a fetal head from a potato, make a cardboard cervix showing dilatation measurements during vaginal delivery, and make a fetal position identification model taking the occiput as a reference point.
15774787|NCT04656561|Drug|ANX007|Form: solution for injection; Route of Administration: IVT
15774788|NCT04656561|Other|Sham comparator|Form and Route of Administration: pressure to mimic IVT injection
15774789|NCT04656548|Device|HydroPICC|PICC lines
15774790|NCT04656535|Drug|AB122|AB122 is a fully human immunoglobulin G4 (hIgG4) monoclonal antibody (mAb) that targets PD-1 immune checkpoint.
15774791|NCT04656535|Drug|AB154|AB154 is a humanized immunoglobulin G1 (IgG1) monoclonal antibody that targets TIGIT immune checkpoint.
15774792|NCT04656535|Drug|Placebo|Saline placebo comparator for pre-surgery treatment in cohort B4
15774793|NCT04656522|Behavioral|Participatory Comic Intervention|This participatory comic intervention promotes sexual violence prevention and post-rape care with refugee youth and health care providers. In 4-hour workshops, a customized comic book featuring eight sexual violence scenarios will be distributed. Each 1-page scenario speaks to a unique theme of sexual violence experiences among youth or post-rape care preferences. During the workshop participants will explore social, sexual, and psychological needs of youth in Bidi Bidi and practice ways of developing and maintaining healthy relationships (youth) as well as discuss post-rape care responses that attend to the needs and priorities of young refugees in Bidi Bidi who have experienced sexual violence (health care providers). Each workshop will include 20 participants and will be facilitated by trained staff from Real Medicine, Uganda. Further, each workshop will have at least 2 facilitators who are trained in the bystander model.
15774794|NCT04656509|Other|4-s sprint inertial load training|A program employing 30 bouts of 4s inertial load sprint training with progressively reduced recovery time (30 to 15 s) between sprints is effective for improving blood volume, VO2peak and maximal power.
15774795|NCT04656496|Behavioral|NOURISH-T+|NOURISH-T+ (Nourishing Our Understanding of Role Modeling to Improve Support and Healthy - Transitions) is a 6 session, psychoeducational program designed to teach parents of childhood cancer survivors with overweight/obesity knowledge and skills to improve the health and lifestyle behaviors for their child and for themselves.
15774796|NCT04656496|Behavioral|Brief NOURISH-T+|Enhanced Usual Care (or Brief NOURISH-T+) is an abbreviated version of the full NOURISH-T+ intervention in which parents are engaged in a one-time information session to also learn knowledge and skills to improve the health and lifestyle behaviors for their child and for themselves.
15774851|NCT04656041|Drug|Carboplatin|Paclitaxel and Carboplatin will be given concurrently with radiation therapy weekly (+/- 1 day).
15774852|NCT04656041|Radiation|Proton Radiation Therapy|Chemoradiation with proton or photon radiation therapy concurrent with weekly Paclitaxel and Carboplatin for 5 weeks
15774797|NCT04656483|Other|Telemedicine Video Feedback Intervention|Mother-child dyads will take part into a 6 video-conference sessions of Video Feedback (vVF). The vVF will be standardized according to previously published RCTs. Specifically, the 6 vVFI sessions will be organized in two subsequent phases: 4 sessions based on sharing the focus on different relational themes, and 2 sessions of interactive integration. In more specific terms, during the first set of 4 sessions the psychologist will review with mothers' segments of the videotapes obtained during the baseline assessment and will focus on four different relational themes: responsiveness, physical stimulation, teaching, and parenting experience. During the interactive integration session, the insights developed from the first 4 videoconferences will be applied to the real-time interaction between the parent and his/her infant under the guidance of the psychologist.
15774798|NCT04656483|Other|Psychoeducational Booklet Intervention|Mothers of this condition will receive an informative booklet addressing the same themes included in the experimental intervention (responsiveness, physical stimulation, teaching, and parenting experience), but not tailored on their own infant status.
15774799|NCT04656470|Drug|Dexmedetomidine|Patients will be delivered dexmedetomidine anesthesia to gain greater understanding of its analgesic effects.
15774800|NCT04656470|Drug|Ketamine|Patients will be delivered ketamine anesthesia to gain greater understanding of its analgesic effects.
15774801|NCT04656457|Device|Treadmill|Treadmill is not used to harness power, but as exercise machines for running or walking in one place. Rather than the user powering the mill, the machine provides a moving platform with a wide conveyor belt driven by an electric motor or a flywheel. The belt moves to the rear, requiring the user to walk or run at a speed matching that of the belt. The rate at which the belt moves is the rate of walking or running. Thus, the speed of running may be controlled and measured
15774802|NCT04656457|Other|resisted exercises|Resistance exercises will be involved in this technique are for upper and lower limb (Exercise program including shoulder flexion, abduction and horizontal adduction, elbow extension and flexion, calf raise, leg extension and squatting)
15774803|NCT04656431|Drug|Hyperpolarized pyruvate (13C)|Given intravenously (IV) injection prior to imaging
15774804|NCT04656431|Procedure|Magnetic resonance imaging (MRI)|MRI scan takes an image of brain and/or spinal cord and will take up to 45 minutes to complete
15774805|NCT04656418|Biological|CSL312|Fully human immunoglobulin G subclass 4/lambda recombinant monoclonal antibody
15774806|NCT04656418|Drug|Placebo|Buffer without active ingredient
15774807|NCT04656405|Other|Online real-time quality measurement and feedback video-based CPR training|"Participants in the online real-time quality measurement and feedback video-based CPR training program group will access an online training center with laptop computers provided by the researcher. All education and communication is conducted online. The study instructors shows the study participants an edited version of the CPR training video used in the conventional CPR training program. A Little Anne QCPR mannequin (Laerdal, Stavanger, Norway) and SkillGuide (Laerdal, Stavanger, Norway) are provided so that the participants can use while watching the video and during the following hands-on practice session.
~After watching the video, hands-on practice will be conducted by the instructor on-line. The instructor will watch each individual participants CPR performance via video conferencing and collect real-time performance data using the QCPR mannequin device. Using this information, the instructor will provide real-time online feedback to participants."
15774808|NCT04656405|Other|Online real-time feedback video-based CPR training without quality measurement|"Participants in the online real-time feedback video-based CPR training without quality measurement program group will access an online training center with laptop computers provided by the researcher. All education and communication is conducted online. When study participants access the online training center, study instructors shows the study participants an edited version of the CPR training video used in the conventional CPR training program. A Little Anne QCPR mannequin (Laerdal, Stavanger, Norway) is provided so that the participants can use while watching the video and during the following hands-on practice session.
~After watching the video, hands-on practice will be conducted by the instructor on-line. The instructor will watch each individual participants CPR performance via video conferencing. The instructor will provide real-time online feedback to participants."
15774809|NCT04656405|Other|Conventional CPR training|"Participants in the conventional CPR training program group will be provided CPR education with the Home Education and Resuscitation Outcome Study (HEROS) program that is currently provided in Seoul, Korea. The HEROS program is a 1-hour training course, consisting of a 30-minute video-based self-instruction training with a mannequin. The program also includes a bystander CPR simulation with a simulated dispatcher using the participants own cell phone. Little Anne QCPR mannequin (Laerdal, Stavanger, Norway) and SkillGuide (Laerdal, Stavanger, Norway) device are provided to measure and give feedback on the participants CPR performance."
15774810|NCT04656392|Diagnostic Test|Breath test (eNose) followed by uTNE.|All participants will receive the breath test with the eNose in the general practice, followed by the uTNE in the hospital.
15774811|NCT04656379|Procedure|spine surgery|Risk factors for postoperative delirium in elderly patients underwent spine surgery will be evaluated.
15774812|NCT04656366|Diagnostic Test|Coronary Angiography|Diagnostic Coronary angiography for patients that presented angina after a previous CABG operation; eventually interventional procedure with PCI (Percutaneous Coronary Intervention)
15774813|NCT04656353|Behavioral|Intervention Arm|Participants randomized to the Intervention Arm will be provided with the website link to the online self-help program and a questionnaire and a distress survey. They will be asked to use the website within two weeks and then to complete these documents after using it and mail them back in a self-addressed stamped envelope. Same documents will be administered at the 3-month follow-up period, and the participant will be given two weeks to complete and return it in a self-addressed stamped envelope. Additionally, participants will also be asked in the 3-month follow-up questionnaire if they are interested in attending a focus group to elaborate on their experience with the psychosocial self-help program. Those who have expressed an interest will be contacted. The focus groups will last about 1-1.5 hours and consist of 3-4 participants. Focus groups will be audio-taped and conducted in either English or Chinese.
15774849|NCT04656041|Drug|FOLFOX/ nal-IRI|"A cycle will be two weeks (14 days) long, with FOLFOX/ nal-IRI administered on days 1-3.
~The order of FOLFOX/ nal-IRI administration is as follows:
~1) Liposomal Irinotecan free base via IV, predetermined dosage per protocol
~2) Oxaliplatin via IV, predetermined dosage per protocol
~3) Leucovorin via IV, predetermined dosage per protocol
~4) 5-Fluorouracil via IV, predetermined dosage per protocol"
15774814|NCT04656353|Behavioral|Control Group|Participants randomized to the Control group will receive standard care (no intervention). They will be used as a baseline to compare groups and assess the effect of the intervention (i.e., the online psychosocial program). At the two weeks following randomization (T1) and the 3-month follow-up periods (T2), they will be asked to complete the questionnaire and distress survey and return them in a self-addressed stamped envelope. Participants will be given two weeks to complete the questionnaire and distress survey. The same documents will be administered at the 3-month follow-up period (T2). Once the 3-month follow-up is completed, each participant will be provided with the website link to view the self-help program.
15774815|NCT04656340|Other|non-medication, non-interventional therapies|non-medication, non-interventional therapies
15774816|NCT04656327|Other|No intervention|There is no intervention in this study. It is a cross-section study evaluating the oral health and nutritional statuses of community-dwelling elders dependent for care for their activities of daily living.
15774817|NCT04656314|Diagnostic Test|Functional MRI scan|Functional MRI scan: Phase contrast, BOLD, Arterial Spin Labeling, Diffusion weighted MRI, T1 mapping, T1rho mapping
15774818|NCT04656301|Drug|Psilocybin|A single dose of psilocybin 25 mg will be administered orally in the Biological Studies Unit of New York State Psychiatric Institute
15774819|NCT04656288|Drug|BI 764198 - Formula A|BI 764198
15774820|NCT04656288|Drug|BI 764198 - Formula B|BI 764198
15774821|NCT04656288|Drug|BI 764198 - Formula C|BI 764198
15774822|NCT04656288|Drug|BI 764198 - Formula D|BI 764198
15774825|NCT04656262|Drug|Cyclophosphamide|Cyclophosphamide is formulated as coated tablets of 50mg for oral administration
15774826|NCT04656262|Drug|Doxorubicin|Doxorubicin is formulated as 60 mg/mq for infusional use (i.v use)
15774827|NCT04656249|Drug|Lenvatinib|Drug doses for BTC are identical, being orally administered at 8mg/d to patients weighing <60 kg and 12mg/d to those ≥60 kg.
15774828|NCT04656236|Biological|3-hydroxybutyrate|3-hydroxybutyrate is a metabolite, produced in the human body.
15774829|NCT04656223|Combination Product|MF/IND/GLY plus sensor system|"There is no treatment allocation. Patients administered MF/IND/GLY plus sensor system by prescription that have started before inclusion of the patient into the study will be enrolled.
~Subjects will receive MF/IND/GLY together with the Propeller add-on sensor for the Breezhaler® according to label."
15774830|NCT04656223|Drug|FDC therapy|There is no treatment allocation. Patients administered FDC therapy by prescription that have started before inclusion of the patient into the study will be enrolled.
15774831|NCT04656210|Radiation|MRI|Non conventional MRI (35 minutes)
15774832|NCT04656210|Other|neuropsychological tests|Standardized and quantified neuropsychological assessment
15774833|NCT04656197|Other|Ocular microbiome|Taxonomical and functional characterization of the ocular microbiome
15774834|NCT04656184|Drug|ANAKINRA|The patients will receive anakinra, an analogue of the IL-1 receptor antagonist, at a starting dose of 4 mg/kg. If patients are still febrile with 12 hours (H12) of treatment, they will receive a supplementary dose of 2 mg/Kg; otherwise, they will remain at a starting dose of 4 mg/kg. If they are still febrile at H24, they will receive a dose of 8mg/kg; otherwise, they will maintain their dose of 6 mg/kg. Patients with temperature <38°C at any point between initiation and day 14, but who develop secondary fever due to KD could have further escalation dose of anakinra until a maximum dose of 8mg/Kg. Patients will receive anakinra during 14 days independently of the period of escalation dose if any. After the last escalation dose, if any necessary, the primary criteria will be measured. Patients not responding to anakinra will follow usual standard care and will complete information related to all the study visits
15774835|NCT04656184|Drug|Intravenous immunoglobulin|The patients will receive a standard therapy, IVIG infusion of 2g/kg, and their treatment will follow usual standard care. Patients in the IVIG treatment will complete information related to the study visits.
15774836|NCT04656171|Radiation|MRI of the hand and forearm,|MRI of the hand and forearm,
15774837|NCT04656158|Other|Physical activity involving exposure to nature: Therapeutic horticulture|2 sessions of 90 minutes of therapeutic horticulture and 2 sessions of 90 minutes of handiwork
15774838|NCT04656145|Device|3M™ Tegaderm™ CHG Chlorhexidine Gluconate I.V. Securement Dressing|On the day of the operation, after the procedure has concluded and the drains have been placed, the surgical drain site that has been randomized to be in the experimental group will receive the chlorhexidine gel dressing. The dressing will remain on the patient until the drain has been removed and the surgical site will be assessed for signs of infection.
15774839|NCT04656132|Behavioral|Physical activity assessment, promotion and monitoring in a preventive cardiology clinic|physical activity assessment promotion and remote home step-count monitoring in a clinical cardiology center
15774840|NCT04656119|Other|there is no intervention in our study|there is no intervention in our study
15774841|NCT04656106|Drug|Ryzodeg®|All patients have been treated at the discretion of the treating physician in accordance with the Ryzodeg® label in South Korea. Hence independently of this study, the treating physician has determined the starting dose of Ryzodeg® as well as any dose adjustments thereafter.
15774842|NCT04656093|Behavioral|Supportive counseling|"Participants in the control arm will receive 3 placebo sessions to control for the potentially confounding effect of personalized attention from the care coach on the relationship between the intervention and outcomes. The interventionist will review a patient education booklet for COPD self-management over the 3 sessions and address any question raised by the study subject."
15774843|NCT04656093|Behavioral|Education on SMB|Goal is to educate patient on SMB based on responses during 15-month interview and screener call, and assess patient's motivation for change.
15774844|NCT04656093|Behavioral|Psychoeducation on ATs for maladaptive beliefs (if applicable)|Goal is to educate patient on relationship between thoughts and SMB, and identify maladaptive beliefs, automatic thoughts, and cognitive distortions.
15774845|NCT04656093|Behavioral|Psychoeducation on emotional response (if applicable)|Goal is to educate patient on relationship between emotions and COPD + SMB, identify
15774846|NCT04656080|Behavioral|CPET exercise testing|"The cardiopulmonary exercise testing (CPET) is done.
~EKG testing will be done as part of the CPET test. Allosure testing will be done at baseline and then at 1 hr, 4 hrs, 1 day, 7 days after CPET."
15774928|NCT04655430|Other|180-second SDF application|Dosage: 180-second 38% SDF solution application
15774860|NCT04656015|Device|MRI|"cMRI will be done only to patients presented with signs of HF, with raised cardiac biomarkers and echocardiographic signs of myocardial injury
~The Lake Louise diagnostic criteria for CMR in myocarditis:
~CMR findings are consistent with myocardial inflammation if at least two of the following criteria are present:
~Regional or global myocardial signal intensity increase in T2-weighted images
~Increased global myocardial early gadolinium enhancement ratio between myocardium and skeletal muscle in gadolinium-enhanced T1-weighted images
~There is at least one focal lesion with non-ischemic regional distribution on late gadolinium enhancement Presence of left ventricular dysfunction or pericardial effusion provides additional, supportive evidence for myocarditis 6. Carotid du"
15774861|NCT04656002|Drug|Vactosertib|Take Baektoseotip (TEW-7197) twice a day for 5 days and take a break for 2 days (5D on/2D off). With this method, progression up to the 28th day is taken as one cycle. Take it with or without food every twelve hours
15774862|NCT04655989|Device|DBB-EXA ES Hemodialysis System|The DBB-EXA ES Hemodialysis Delivery System is intended to support an optional online priming, rinseback and emergency bolus features. The appropriate priming of the hollow fiber dialyzer and blood tubing lines removes debris and air prior to device use, as well as ensuring proper rinseback.
15774863|NCT04655976|Biological|Cobolimab|Route of administration : IV infusion
15774864|NCT04655976|Biological|Dostarlimab|Route of administration : IV infusion
15774865|NCT04655976|Drug|Docetaxel|Route of administration : IV infusion
15774866|NCT04655963|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|MagVenture MagPro TMS System would be utilized to deliver 3-minute sessions of intermittent theta burst to left dorsolateral prefrontal cortex.
15774867|NCT04655950|Other|protocols and practices for the immobilization of vertebral osteomyelitis in different French hospitals and bone and joint infections Centers|"Evaluation of the frequency of neurological complications in a large prospective cohort, and to identify clinical and imaging risk factors for neurological complications.
~We search for association between type and duration of spine immobilization and neurological status at the end of follow-up"
15774929|NCT04655417|Drug|Sodium Tetradecyl Sulfate|DRUG WILL BE INJECTED TO ALLAPTIENTS ACCORDING TO STANDARD PROTOCOL
15774930|NCT04655404|Drug|Larotrectinib|Larotrectinib monotherapy x2 cycles followed by disease evaluation
15774931|NCT04655404|Procedure|Larotrectinib|Surgical cohort: Larotrectinib x 3-5 days prior to definitive surgery
15774932|NCT04655391|Drug|Bosutinib Monohydrate|Given PO
15774933|NCT04655391|Drug|Decitabine|Given IV
15774868|NCT04655937|Other|Acceptance and Commitment Therapy|eight two hour remote sessions (50 minutes activity + 20 minute break + 50 minutes activity). Acceptance and Commitment Therapy (ACT) is a third wave transdiagnostic cognitive-behavioural therapy that supports clients to adjust to current experiences and 'commit' to behaviours that are congruent with their personal values, in order to promote psychological well-being and prevent future mental health crisis. ACT uses a variety of experiential techniques to support this process including: mindfulness practices; exercises to identify personal values; commitment to goals for valued living.
15774869|NCT04655937|Other|Social Support (Attention Control)|eight two hour remote sessions (50 minutes activity + 20 minute break + 50 minutes activity). The active comparator is a group-based, paraprofessional-facilitated socialisation protocol, which has been used as a credible control for factors such as enjoyment of therapy, dropout rates and client expectations. It is developed to be acceptable to potential trial participants and control for the Hawthorne and placebo effects of trial participation, without containing putative active elements of the ACT-based intervention. The goal of the attention control comparator group is to engage participants in neutrally loaded topics that are of interest to the participants for the same duration - and in the same remote medium - as the intervention group. This comparator also tackles the methodological issues of clustering caused by group delivery in the intervention arm.
15774870|NCT04655924|Device|Clinical Decision Support System|Clinical Decision Support System using Measurement-Based Care and Digital Decision Support Platform
15774871|NCT04655911|Biological|ABO-101|Gene therapy rAAV9.CMV.hNAGLU
15774872|NCT04655898|Drug|[14C]CC-90001|Oral
15774873|NCT04655885|Behavioral|Optimization of cardiac flow by base water-electrolyte supply|optimization of cardiac flow by base water-electrolyte supply of 1 ml / kg / h by Ringer Lactate® and faced with any decrease of more than 10% of the VES compared to the reference VES, achievement of an optimization of the preload by administration of 250 ml of Ringer Lactate® with renewal until correction of the VES.
15774874|NCT04655885|Behavioral|Control arm|increase basic hydro-electrolyte supply of 6 ml / kg / h by Ringer Lactate® and 1: 1 blood loss compensation by crystalloids of the same nature.
15774875|NCT04655872|Drug|[14C]TPN171H|A single 10 mg oral dose of [14C]TPN171H containing approximately 100 microcurie of [14C]-TPN171H.
15774876|NCT04655859|Diagnostic Test|saliva cotton swab|evaluate the role of thiol/disulfide homeostasis and oxidative stress in the saliva of children with severe early childhood caries and healthy group
15774877|NCT04655846|Behavioral|Nursing intervention outcome: Breastfeeding Counseling (5244)|"Educational sessions: The nursing professional will carry out 1 educational session per week, for 4 weeks; each lasting between 45 and 60 minutes. The topics that make up each of the activities are:
~Educational Session: Awareness towards the process of breastfeeding. Inform about the psychological and physiological benefits of breastfeeding.
~Educational session: Teach the composition of breast milk. Teach the baby's correct alignment, latch, and areolar understanding of the breast. Instruct on breastfeeding positions.
~Educational Session: Explain the extraction and conservation of breast milk.
~Educational session: Explain the signs, symptoms, and management strategies for duct obstruction, mastitis, and nipple trauma. Talk about your needs for rest, hydration, and diet during breastfeeding."
15774878|NCT04655846|Behavioral|Nursing education about maternal care and usual education in maternity preparation course|Educational intervention by a nursing professional on the provision of adequate care at the level of growth and development in infants under one year of age, activities not related to the breastfeeding process
15774879|NCT04655833|Other|phone survey|A questionnaire about the current symptoms and satisfaction for received treatment will be conducted over the phone for patients.
15774880|NCT04655807|Drug|JNJ-64304500|JNJ-64304500 will be administered as SC injection.
15774881|NCT04655807|Drug|Placebo|Matching placebo will be administered as SC injection.
15774882|NCT04655807|Drug|Adalimumab|Adalimumab will be administered as SOC biological therapy.
15774883|NCT04655807|Drug|Ustekinumab|Ustekinumab will be administered as SOC biological therapy.
15774884|NCT04655794|Drug|3HP|all patients taking 3HP under directly observed preventive therapy (DOPT) program
15774885|NCT04655781|Procedure|idiopathic macular hole (MH) surgery|Idiopathic Macular Hole Surgery with Different Internal Limiting Membrane Peeling Patterns
15774886|NCT04655768|Device|Palmar Plate Fixation|Patients are treated by surgery (palmar plate)
15774889|NCT04655742|Device|VitaFlow™ Transcatheter Aortic Valve System|VitaFlow™ Transcatheter Aortic Valve System contains a valve stent-VitaFlow™ Aortic Valve, a delivery system-VitaFlow™ Delivery System,loading tools, a balloon dilatation catheter, and an introducer set
15774890|NCT04655729|Drug|Infliximab|Blood collection
15774891|NCT04655716|Drug|Sodium Bicarbonate 150Meq/L/D5W Inj|Urine alkalinisation will be performed to achieve urine pH 7.5-8.5. Urine alkalinisation will be continued for up to 10 days or until patient is discharged or until primary endpoint is reached. Urine pH will be measured at point of care by dipstick.
15774892|NCT04655703|Device|DJO X4 brace with Motion Intelligence Platform|The X4 Knee brace with the Motion Intelligence platform uses both a bio-measurement equipment with an interactive application thereby providing the patient with immediate feedback on their exercise regime. The X4 Knee brace is a postoperative brace worn by a patient to monitor compliance to prescribed protocol based on the movement and function of the knee joint. The device also connects wirelessly to a companion mobile application, Motion Intelligence, and streams both real-time and collected data for review and record collection. Prescribed exercises are uploaded into the patient application, with a number of the exercises actively tracked by the Mi360 sensor housed in the X4 brace. Compliance can be tracked by the physician in real-time between postoperative visits and any medical staff on a separate dashboard.
15774893|NCT04655690|Drug|NNC0471-0119|Participants will be randomised to either of five dose levels 0.3, 0.6, 1.2, 2.4 or 3.6 of NNC0471-0119 nanomol per kilogram body weight, which will be administered as a single dose. NNC0471-0119 will be administered subcutaneously (s.c., under the skin) in fasting state.
15774894|NCT04655690|Drug|Fast-acting insulin aspart|Participants will get a fixed dose of 0.2 units of fast-acting insulin aspart (Fiasp®) per kilogram body weight, administered subcutaneously (s.c., under the skin) in fasting state.
15774895|NCT04655677|Biological|CD19/CD20-directed CAR-T cells|Autologous 2nd generation CD19/CD20-directed CAR-T cells, single infusion intravenously
15774896|NCT04655664|Diagnostic Test|not currently consumed vitamin D supplements regularly|The tests carried out were examination of 25 (OH) D and 1.25 (OH) D levels of serum and saliva, examination of demographic data, and other anthropometries. The examination was carried out by taking 5 mL of blood and 2 mL of saliva, and then checking the serum and saliva levels of 25 (OH) D and 1.25 (OH) D. Before the examination, the research subjects were asked not to consume food or drink for at least 90 minutes before being examined. Centrifugation was carried out (2500 g, 10 minutes) and the product immediately stored at -20 oC. In the serum examination, after the blood was drawn, centrifugation was carried out and the product stored at -20 oC for further determination of the levels of 25 (OH) D and 1.25 (OH) saliva.
15774897|NCT04655664|Diagnostic Test|consumed vitamin D supplements regularly|The tests carried out were examination of 25 (OH) D and 1.25 (OH) D levels of serum and saliva, examination of demographic data, and other anthropometries. The examination was carried out by taking 5 mL of blood and 2 mL of saliva, and then checking the serum and saliva levels of 25 (OH) D and 1.25 (OH) D. Before the examination, the research subjects were asked not to consume food or drink for at least 90 minutes before being examined. Centrifugation was carried out (2500 g, 10 minutes) and the product immediately stored at -20 oC. In the serum examination, after the blood was drawn, centrifugation was carried out and the product stored at -20 oC for further determination of the levels of 25 (OH) D and 1.25 (OH) saliva.
15774898|NCT04655651|Other|No intervention|There is no intervention for both groups.
15774901|NCT04655625|Biological|Group A (AG0302-COVID19)|2 mg of AG0302-COVID19 twice at 2-week intervals
15774902|NCT04655625|Biological|Group A (Placebo)|Placebo twice at 2-week intervals
15774903|NCT04655625|Biological|Group B (AG0302-COVID19)|2 mg of AG0302-COVID19 twice at 4-week intervals
15774904|NCT04655625|Biological|Group B (Placebo)|Placebo twice at 4-week intervals
15774905|NCT04655599|Drug|Olorinab|Olorinab tablet by mouth, 3 times a day for 4 days with a final dose on Day 5.
15774906|NCT04655599|Drug|Placebo|Olorinab matching placebo tablet by mouth, 3 times a day for 4 days with a final dose on Day 5.
15774907|NCT04655586|Drug|rNAPc2|two dose levels of rNAPc2
15774908|NCT04655586|Drug|Heparin|standard of care heparin per institution (therapeutic or prophylactic regimen)
15774909|NCT04655573|Procedure|Breast Cancer Tumor Resection|Patients with ABC will be receiving a biopsy, and a PDMO from the patient's biopsies will be generated from it. It is a model correlating clinical response with PDMO sensitivity to the most common forms of chemotherapy used in advanced breast cancer care.
15774910|NCT04655560|Other|no intervention|qualitative study
15774911|NCT04655547|Other|Dietary guidance|Dietary guidance with focus on texture and energy intake, preformed by certified dietitians.
15774912|NCT04655534|Other|Inspiratory Muscle Warm-up (IMW)|The IMW protocol applied before each inspiratory muscle training (IMT) session by using a threshold inspiratory muscle trainer. The IMW protocol consists of 2 sets of 30 breaths in 40% of the maximal inspiratory pressure (MIP), with 1 min rest between sets. The intensity of MIP adjusted by two weekly MIP measurements.
15774913|NCT04655534|Other|Inspiratory Muscle Training (IMT)|The IMT applied twice a day as 30 breath repetitions at 60% of the maximal inspiratory pressure (MIP). The intensity of MIP adjusted by two weekly MIP measurements.
15774914|NCT04655534|Other|Respiratory exercises and aerobic exercise program|Then the respiratory exercises and aerobic exercise program performed in both groups in each session. Aerobic exercise program; After 5 min of general body warming, applied 20 min with a load of 4-6 according to the modified Borg scale on the treadmill, finished with 5 min whole body cool-down. All program applied to 3 days a week for 8 weeks under the supervision of a physiotherapist and other days of the week without a supervisor.
15774915|NCT04655508|Drug|Seretide|"For children between 6 to 11 years (< 12 years): 50 μg inhaled fluticasone propionate and 25 μg salmeterol (SERETIDE® 50/25) :two puffs twice a day from randomisation during 6 months using inhalation chamber
~- For children between 12 to 17 years (> or = 12 years) : 125 μg inhaled fluticasone propionate and 25 μg salmeterol (SERETIDE® 125/25): two puffs twice a day from randomisation during 6 months using inhalation chamber"
15774916|NCT04655508|Drug|Placebo|For children between 6 to 11 years (< 12 years): placebo of SERETIDE® 50/25 :two puffs twice a day from randomisation during 6 months using inhalation chamber For children between 12 to 17 years (> or = 12 years) : placebo of SERETIDE® 125/25: two puffs twice a day from randomisation during 6 months using inhalation chamber
15774917|NCT04655495|Dietary Supplement|Low FODMAPs /balanced gluten free diet|Dietary Supplement: Balanced low FODMAPs /gluten free diet
15774918|NCT04655482|Drug|Aflibercept Injection|"Intravitreal injection of aflibercept using treat-and-extend regimen
~:Three monthly loading injections followed by proactive treatment using TAE regimen. Extension of injection interval by 2 weeks. The maximum injection interval was set as 16 weeks."
15774919|NCT04655443|Other|Standard Care|Standard cardiovascular care
15774920|NCT04655430|Other|3-second SDF application|Dosage: 3-second 38% SDF solution application
15774921|NCT04655430|Other|5-second SDF application|Dosage: 5-second 38% SDF solution application
15774922|NCT04655430|Other|10-second SDF application|Dosage: 10-second 38% SDF solution application
15774923|NCT04655430|Other|15-second SDF application|Dosage: 15-second 38% SDF solution application
15774924|NCT04655430|Other|30-second SDF application|Dosage: 30-second 38% SDF solution application
15774925|NCT04655430|Other|45-second SDF application|Dosage: 45-second 38% SDF solution application
15774926|NCT04655430|Other|60-second SDF application|Dosage: 60-second 38% SDF solution application
15774927|NCT04655430|Other|120-second SDF application|Dosage: 120-second 38% SDF solution application
15774939|NCT04655378|Other|Mass Sepctrometry|Mass spectrometry (LC/MS) of purified immunoglobulins
15774940|NCT04655365|Drug|Enzalutamide capsule|160 mg po id
15774941|NCT04655352|Dietary Supplement|Bacillus subtilis MB40|1-week placebo (maltodextrin and excipients) lead-in followed by 250 mg capsule (5 billion CFU/capsule) administered twice daily for 21 days
15774942|NCT04655339|Drug|Bilateral abdominal Lap-TAP|A total of 30ml of anesthetic (0.25% Bupivacaine HCL), 0.25% Liposomal Bupivacaine (Exparel®) or control will be injected into the transversus abdominis plane bilaterally. A long spinal needle attached to a 30cc syringe with the TAP block solution or control will be used to inject the patient. The needle puncture will be halfway between the subcostal margin and anterior superior iliac spine at the midclavicular line. With laparoscopic guidance, needle will enter through the skin, external oblique and internal oblique. Once the needle is in place, injection of 30 ml on each side will be applied between the internal oblique and transversus abdominis muscle. The injection of bupivacaine into this abdominal wall induces an observable bulge, indicating accuracy of the procedure. These steps will be repeated on the contralateral side of the abdomen. All patients will receive 10 ml bupivacaine 0.25% pre-incision infiltration.
15774943|NCT04655326|Biological|Flore|personalized blend of GRAS approved probiotic strains, prebiotics, and botanicals
15774944|NCT04655313|Drug|ARQ-151 cream 0.3%|ARQ-151 cream 0.3% applied to chronic plaque psoriasis lesions once a day for 4 weeks
15774945|NCT04655274|Diagnostic Test|The Quality of Vision questionnaire|The Quality of Vision questionnaire rates glare, halos, starbursts, hazy/blurred/double vision, distortion, focusing difficulties, fluctuation, and depth perception conditions.
15774946|NCT04655248|Device|Transcatheter Aortic Valve Implantation/Replacement|The device is placed in patients heart at the level of aortic valve through a transfemoral access from femoral groin as indicated in device IFU
15774947|NCT04655235|Genetic|Genotyping|Genotyping of glutamatergic, GABAergic, dopaminergic and other CNS-related genes
15774948|NCT04655222|Drug|Interferon Beta Therapy|Administered as specified in the treatment arm.
15774949|NCT04655209|Behavioral|apply a-tDCS on the ipsilesional M1 followed by MT (M1-Seq)|The participants in the M1-Seq group will first receive a-tDCS over ipsi-lesional M1 without any active arm practice for 20 minutes. For the next 20 minutes, the participants will start the MT, while the electrodes will be remained on the scalp with the stimulator off (sham tDCS condition). Then the electrodes will be removed, and the participants will receive additional 20 minutes of MT without tDCS followed by 30 minutes of functional task practice.
15774950|NCT04655209|Behavioral|apply a-tDCS on the ipsilesional PMC followed by MT (PMC-Seq)|The procedures for the PMC-Seq group will be the same as the M1-Seq, except that a-tDCS will be applied on ipsilesional PMC but not M1.
15774951|NCT04655209|Behavioral|MT only with sham tDCS (MT)|For the MT group, the procedure will be the same as the other groups except that sham tDCS will be used for the first 40 minutes.
15774952|NCT04655196|Other|SOLUS-D + weekly feedback by a coach|internet-based self-help
15774953|NCT04655196|Other|SOLUS-D + weekly automated messages|internet-based self-help
15774954|NCT04655183|Drug|Niraparib|Niraparib will be administered orally, once daily.
15774955|NCT04655183|Drug|M4344|M4344 will be administered once daily or on an intermittent schedule in combination with niraparib.
15774956|NCT04655183|Drug|Niraparib|Niraparib will be administered orally once daily at the RDE as determined in Part 1 of this study.
15774957|NCT04655183|Drug|M4344|M4344 will be administered at a dose and schedule that was determined as RDE in Part 1A in combination with niraparib.
15774958|NCT04655183|Drug|Niraparib|Niraparib will be administered orally, once daily. Dose of niraparib will be escalated beyond the dose in Part 1A.
15774959|NCT04655183|Drug|Niraparib|Niraparib will be administered as single agent at the approved dose.
15774960|NCT04655170|Drug|Revefenacin (YUPELRI) & Formoterol (Perforomist)|Revefenacin is a Long-acting anticholinergics (LAMAs) and Formoterol is Long-acting bronchodilators, beta-agonists (LABAs).
15774961|NCT04655170|Drug|Albuterol Inhalation Aerosol (short-acting beta-agonists) & Ipratropium Aerosol (short-acting anticholinergic)|Albuterol Inhalation Aerosol (short-acting beta-agonists) & Ipratropium Aerosol (short-acting anticholinergic)
15774962|NCT04655157|Drug|encorafenib|A small molecule BRAF inhibitor that targets key enzymes in the MAPK signaling pathway.
15774963|NCT04655157|Drug|nivolumab|A programmed death receptor-1 (PD-1) blocking monoclonal antibody that works by helping the immune system to slow or stop the growth of cancer cells.
15774964|NCT04655157|Drug|ipilimumab|A monoclonal antibody medication that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.
15774965|NCT04655157|Drug|binimetinib|A small molecule, selective inhibitor of MEK, a central kinase in the tumor-promoting MAPK pathway that may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
15774966|NCT04655144|Drug|Dexamethasone|Dexamethasone delivered to the uterine arterial bed, prior to embolization.
15774967|NCT04655144|Drug|Saline|Saline delivered to the uterine arterial bed, prior to embolization.
15774968|NCT04655131|Dietary Supplement|Whey protein isolate|Commercially available, FDA approved whey protein isolate for dietary supplementation
15774969|NCT04655118|Drug|TL-895|TL-895 is an experimental tyrosine kinase inhibitor anticancer drug taken by mouth.
15774970|NCT04655105|Device|root canal rotary files|post operative pain evaluation using different rotary file system
15774971|NCT04655092|Biological|P1101 (Rropeginterferon alfa-2b)|The subjects who have completed the 52-week treatment duration in Study A19-201 will be treated with P1101, starting at the dose at Week 50. The dose during this study may be increased or decreased up to 500 μg depending on the condition. This study will be continued as a post-marketing clinical study after acquisition of the marketing approval of P1101.
15774972|NCT04655079|Device|Anodal transcranial direct current stimulation (a-tDCS)|tDCS is delivered by a battery-driven constant current stimulator thought a pair of saline soaked surface sponge electrodes. The active electrode (anode) is placed on the scalp over the left dlPFC (F3) according to the 10 to 20 international electroencephalogram coordinates) and the cathode is placed over the right deltoid muscle. During real stimulation a constant current of 2mA (milli Ampere) is applied for 20 minutes.
15774973|NCT04655079|Device|Sham Condition|For the sham condition the electrode placement is the same of active tDCS but the electric current is ramped down 5 seconds after the beginning of the stimulation.
15774974|NCT04655053|Behavioral|Goal intention|Researcher instructs participants to adopt and learn the goal intention requesting them to write it three times and verbally repeat once.
15774975|NCT04655053|Behavioral|Implementation intention to initiate the behavior|Researcher instructs participants to adopt and learn the goal intention and the plan requesting them to write it three times and verbally repeat once.
15774976|NCT04655053|Behavioral|Implementation intention to manage the goal preference (avoiding behavior or not)|Researcher instructs participants to adopt and learn the goal intention and the plan requesting them to write it three times and verbally repeat once.
15774977|NCT04655040|Drug|Caffeine|100milligram (mg) tablet taken orally in period 1 and period 2
15774978|NCT04655040|Other|Ritlecitinib|200 milligrams (mg) taken orally once a day(QD) for 8 days
15774981|NCT04655014|Other|High Intensity Circuit Training|The High Intensity Circuit Training comprises of 7 full body exercises as per recommendation of ACSM Where the participants shall be given total of 18 sessions of their respective protocol, comprising of 20 minutes, 3 times/ week for duration of six weeks
15774982|NCT04655001|Behavioral|MORPH|A 12-week movement and caloric restriction intervention meant to reduce pain and body weight.
15774983|NCT04654988|Drug|Prednisone|Prednisone: 1 mg/kg daily for 4 weeks followed by gradually tapered dose for 5 months
15774984|NCT04654988|Drug|Azathioprine|Azathioprine: 2 mg/kg daily for 12 months
15774985|NCT04654988|Drug|Placebo Prednisone|Placebo Prednisone
15774986|NCT04654988|Drug|Placebo Azathioprine|Placebo Azathioprine
15774987|NCT04654975|Procedure|Esophagectomy for esophageal cancer|Surgical removal of (a part of) the esophagus and surgical reconstruction with another organ (mostly stomach, but may be colon or small bowel as well)
15774988|NCT04654962|Procedure|Anesthetic nerve block|iliac fascia block is an analgesic technique that uses local anesthesia, is effective and relatively safe in preoperative management. The target of this block is the femoral and lateral femoral cutaneous nerves; which innervate the anterior aspect of the thigh, as well as the muscle and periosteum that covers the femoral head, neck and proximal femur.
15774989|NCT04654949|Other|Horticultural Therapy|The horticultural therapy sessions are conducted by the occupational therapists or therapy assistants using the mobile horticultural kits. The horticultural activities are designed to stimulate the senses through interaction with specific tasks and the environment, promote social interaction, mobility and also promote a sense of self-worth through various horticultural activities such as planting seeds, transplanting plants, trimming and watering plants.
15774990|NCT04654936|Behavioral|MIND diet|12 week MIND diet study: Participants access a website that is theory driven using the Behaviour Change Wheel to help motivate and promote MIND diet adherence. Participants are to consume MIND diet foods daily and meet MIND diet weekly recommendations
15774991|NCT04654936|Behavioral|MIND diet with no support|Participants are to consume MIND diet food recommendations over a 12 week period with no support except for a self-monitoring resource and MIND diet guidelines
15774992|NCT04654910|Behavioral|PROMIS Score Explanation|The surgeon completing the clinical visit with the participant will explain what the PROMIS tool is, the purpose of the tool and what the participant's scores mean using a script.
15774993|NCT04654910|Behavioral|Placebo|Subjects will complete the PROMIS assessment but will not receive an explanation of the tool.
15774995|NCT04654884|Other|Auricular acupuncture (AA)|The add-on treatment will be administered at the treatment sessions with their caregiver (i.e. registered nurse, psychologist, curator), and at each session the participants receive 5 sterile stainless needles in each outer ear. The needling is standardised according to the NADA-protocol. The needles will remain in the outer ears for approximately 45 minutes, and will be removed by the care giver.
15774996|NCT04654871|Dietary Supplement|Chondroitin Sulfate|Glucosamine 500 mg Chondroitin sulfate sodium 400mg 3/day
15774997|NCT04654871|Procedure|Resistance exercise training|"Treadmill walking 5-10 min for warm up Strength training: (80% of 8RM)
~Supervised exercise thrice a week and Home Exercise 4 times a week Leg press knee extension Knee flexion Terminal knee extension Mini squats 3 sets 8 reps 10-15 s rep rest interval 1-2 min set rest interval"
15774998|NCT04654871|Procedure|Manual therapy / Joint Mobilization|Ant. tib-fem glide Post tib-fem glide thrice a week Pattelo-femoral joint mobilization
15774999|NCT04654871|Procedure|THE therapy|Interferential and Heating for 20 min
15775000|NCT04654858|Procedure|Direct composite restorations|bulk-fill composite (Filtek BulkFlow, 3M Espe) will be used aftar infiltration or block anaesthesia for affected molar,following by carious tissue removal. Marginal bevelling of enamel will be performed. A universal adhesive (Scotchbond Universal, 3M Espe) will be placed after selective enamel etching A bulk-fill composite will be used and covered using a nanohybrid composite, (Filtek XT, 3M Espe).
15775001|NCT04654845|Procedure|Pulpotomy|"Access to pulp chamber. Removal of the pulp chamber tissue. Use of Sodium Hypochlorite (5.25% NaCl) during the whole procedure and in the amount considered appropriate by each operator.
~Wait until confirmation of absence of bleeding from the conducts. Placement of polytetrafluroethylene in pulp chamber. Placement of temporary filling. Reduction of the occlusal surface of the tooth until there is no contact with the articulating paper from 200μ."
15775002|NCT04654845|Procedure|Pulpectomy|"Access to pulp chamber. Removal of the pulp chamber tissue. Use of Sodium Hypochlorite (5.25% NaCl) during the whole procedure and in the amount considered appropriate by each operator.
~Establishment of working length by means of Electronic Apex Locator and a number 8 K file.
~Access to all conducts with a number 10 K file. Rotary instrumentation with one reciprocating system up to working length and up to an apical diameter of 25.
~Placement of polytetrafluroethylene in pulp chamber. No intermediate medication will be filled into the conducts.
~Placement of temporary filling. Reduction of the occlusal surface of the tooth until there is no contact with the articulating paper from 200μ."
15844861|NCT04084184|Drug|HGP1602|Dapagliflozin 10mg
15775003|NCT04654819|Device|Dental anesthesia simulator usage|Training on dental anesthesia simulator
15775004|NCT04654793|Device|Robot assisted inclined bed treatment and FES|FES was performed at the same time as the robot-assisted inclined bed treatment once a day for 30 minutes, 5 days a week for 4 weeks.
15775005|NCT04654793|Device|conventional inclined bed treatment|conventional inclined bed treatment for 30 minutes once a day for 4 weeks, 5 days a week
15775006|NCT04654780|Behavioral|Taxes|"a High in food tax will be applied to study changes in purchasing and consumption behavior of participants in this group. The tax will correspond to a 20% increase over the market price, that is, a tax that reaches the levels recommended by the WHO."
15775007|NCT04654780|Behavioral|Subsidies|A subsidy will be applied to fruits and vegetables that means a reduction of 20% in their price, to study the changes in purchasing behavior and of the participants of said group.
15775008|NCT04654780|Behavioral|Control|Average or current food prices will apply. Based on the average of the values reported by three supermarkets
15775009|NCT04654767|Other|Tissue sampling|"Blood collection via venipuncture into citrate- or ethylenediaminetetraacetic (EDTA)-containing vacutainer tubes and into serum tubes. Explant lung tissue obtained from patients that underwent lung transplantation.
~Non-transplanted donor lungs that had been harvested for transplantation, but not implanted because of size-reduction serve as controls."
15775010|NCT04654754|Device|high-flow high humidity oxygen device with tracheostomy adapter|This device can provide heat and humidified gas for spontaneous breathing patients with tracheostomy at a high gas flow rate.
15775011|NCT04654741|Drug|Medroxyprogesterone Acetate|1 pill per day
15775012|NCT04654741|Drug|Ganirelix Acetate|1 injection per day
15775013|NCT04654728|Procedure|Active Comparator: ePTFE graft|In this group, anterior sector of the right lobe graft will be reconstructed using Dacron vascular grafts
15775014|NCT04654715|Procedure|Gracilis flap interposition for rectouretral fistula management|Gracilis flap interposition is a surgery for rectouretral fistula
15775015|NCT04654689|Dietary Supplement|Liposomed polyphenols resveratrol and curcumin|Combination of resveratrol (75mg) and curcumin (200mg) liposomed
15775016|NCT04654689|Other|Placebo for liposomed resveratrol and curcumin|Water with sucrose replacing the liposomed polyphenols
15775017|NCT04654689|Dietary Supplement|Isocaloric Diet|40% carbohydrates, 40% lipids and 20% proteins
15775018|NCT04654689|Drug|G04CB02|G04CB02, in a single daily dose for 6 months
15775019|NCT04654689|Other|Placebo microcrystalline methylcellulose|Placebo replacing G04CB02
15775020|NCT04654676|Drug|Vildagliptin|Vildagliptin added on to stable doses of pre-mixed insulin with or without metformin
15775021|NCT04654637|Behavioral|Nutrition and Exercise Strategies|Multiple Interactive with Nutrition and Exercise Strategies
15775022|NCT04654624|Drug|SDF|Steps of SDF 38% application were carried out following the manufacturer's instructions. Eligible primary carious teeth were first dried and isolated using cotton rolls and gauze. Adjacent soft tissues were isolated using petrolleum gelly in order to prevent any irritation or staining from SDF that was directly placed into the carious lesion using a microbrush, allowed to absorb for 2 minutes, then dried with air. Parents were instructed that children should not eat for one hour after treatment. The second application was done after 6 months.
15775023|NCT04654624|Drug|ART|Steps of ART caries removal were carried out following the Frencken et al. criteria where the cavity opening was widened using the tip of a dental hatchet. The carious dentin was then removed using a spoon excavator starting at the enamel-dentin junction, unsupported enamel was removed using the hatchet, and finally the cavity was cleaned using a wet cotton pellet and dried. After complete removal of infected dentin, the cavity walls and floor were conditioned for 10 seconds, washed and dried with cotton pellets, then restored with chemically cured glass ionomer cement that was applied under finger pressure, then coated with petroleum jelly.
15775024|NCT04654611|Drug|preservative free tafluprost 0.0015%|preservative free prostaglandin analogue option for treatment of primary open angle glaucoma and ocular hypertension patients
15775025|NCT04654598|Other|BPA levels|BPA (bisphenol A) in urine, blood and follicle fluid samples
15775026|NCT04654585|Other|The STOP intervention|The stop intervention is a heath professional (medical doctor) led intervention assisting smokers with low socioeconomic position in their smoking cessation attempt. It consists of routine care and adapted advice supplemented with a free delivery of any or several type(s) of nicotine replacement therapy (NRT) (patches, inhalers, gum, tablets, etc.) and/or an e-cigarette + e-liquid. The delivery of those smoking aids is based on the smokers' preference and choice.
15775027|NCT04654585|Other|Standard Care|"Participants randomised to the standard care group will be given standard care in assisting their smoking cessation attempt, but without free delivery of NRT or e-cigarettes.
~Standard care includes motivational interviewing, advice to quit and prescription for NRTs. The number and online address of the French smoking cessation support helpline could also be provided. Health professionals will also be in position to prescribe NRT or other treatments (for example: Varenicline or Bupropion) which can help with smoking cessation, according to routine practice. The health professional could also give advice on e-cigarette use if he or she finds it suitable."
15775028|NCT04654572|Diagnostic Test|Myotonometric measurement|Myotonometric assessment can predict the muscle stiffness, tone and elasticity
15775029|NCT04654559|Other|Unobtrusive data collection using wearable non-invasive sensors|Two wearable non-invasive sensors will be mounted to the patients skin (lateral rib cage and foot). These wearable non-invasive sensors are measuring unobtrusively skin based parameters (no diagnosis will be made), which will be used for fever detection algorithm development..
15775030|NCT04654546|Other|Ultrasound abdominal scan|"A complete ultrasound scan of the abdominal organs using a clinical ultrasound device in the Imaging Institute at Haemek medical center. The ultrasound images will be visually coupled to previous CT images of the same patient at the time of the examination, using a Fusion system located in the ultrasound device mentioned above.
~The coupled CT and ultrasound images will be encoded and be sent to the SAMPL laboratory in Weizmann institute, there it will serve as a learning platform for the artificial intelligence system."
15775087|NCT04654000|Procedure|Rheopheresis procedure|rheopheresis is performed using an automated monitor (Plasauto, company HemaT) in a double-filtration cascade. Plasma purify from of high molecular weight proteins
15775149|NCT04653415|Drug|Methylprednisolone 125 mg|"The study group will receive as pre-emptive analgesia a single dose of 300 mg oral gabapentin and 125 mg intravenous methylprednisolone."
15775031|NCT04654533|Other|COSC|"COSC is professional development program for early childcare providers adapted from the Circle of Security-Parenting (COSP) model. It is a manualized intervention that leverages research on attachment relationships combining psycho-education with a mentalization-based approach. The model uses pre-produced video vignettes of secure and problematic caregiver-child interactions to illustrate how caregivers' may struggle in meeting children's' attachment needs.
~Participants are invited to reflect on how they meet and perhaps still not meet the needs of the children in their care with a particular focus on the challenging or 'difficult' children.
~The COSP manual has been translated into Danish (Cooper, Hoffman and Powel, 2020, translated by Pedersen, Kronendorf von Wowern, Lier, & Smith-Nielsen), and the additional COSC material has been translated into Danish for the purpose of this study."
15775032|NCT04654520|Other|Drug therapy concurrent radiotherapy for primary tumor omitted CTV|Thoracic intensity modulated radiotherapy for primary tumor omitted CTV+Chemotherapy or Targeted drug therapy
15775033|NCT04654507|Drug|Dexamethasone Oral|Drug: Dexamethasone 0.3mg/kg/dose twice daily for 3 days
15775034|NCT04654507|Drug|Placebo|Placebo
15775035|NCT04654494|Procedure|Total proctocolectomy|excision of the whole large bowel including colon and rectum and end ileostomy fashioning
15775036|NCT04654494|Procedure|Total colectomy|excision of the colon with preservation of the rectum
15775037|NCT04654494|Procedure|Segmental colectomy|excision of a segment of colon
15775038|NCT04654481|Device|HCFWO|The Afflovest device is a High Frequency Chest Wall Oscillation (HFCWO) device, a medical vest that uses vibrations to loosen and mobilize mucus in the lung secretions and help clear the airways.
15775039|NCT04654481|Other|Standard Care Plus Monitoring|Monitoring via home spirometry, pulse oximetry, temperature checks, telehealth check-in and patient-reported outcome assessments.
15775040|NCT04654468|Drug|Crovalimab|Crovalimab will be administered at a dose of 1000 mg IV (for participants with body weight between 40 and 100kg) or 1500 mg IV (for participants with body weight >=100kg) on Week 1 Day 1. On Week 1 Day 2 and on Weeks 2, 3 and 4, it will be administered at a dose of 340 mg SC. For Week 5 and Q4W thereafter, it will be administered at a dose of 680 mg SC (for participants with body weight between 40 and 100kg) or 1020 mg SC (for participants with body weight >=100kg). Dosing schedule will be as described above.
15775041|NCT04654455|Other|Describe the evolution of dry eye between 1 month and 3 months post-LASIK|Dry eye will be assessed through the OSDI (Ocular Surface Disease Index) questionnaire. The questionnaire will be dispensed during consultations by an orthoptist or an intern/junior doctor, at 1 month and at 3 months post-LASIK.
15775042|NCT04654442|Diagnostic Test|TestNPass|Patients will undergo saliva sampling. Grenoble University Hospital lab will perform diagnosis using TestNPass IVDMD. Results won't be used for patient care (only recorded for RESEARCH purpose).
15775043|NCT04654429|Drug|IV Ondansetron 4mg|IV ondansetron 4mg
15775044|NCT04654429|Other|Higher OT temperature range|OT temperature set to 19-22 degree celsius
15775045|NCT04654429|Drug|Placebo|IV Normal Saline 2cc will be given
15775046|NCT04654429|Other|Lower OT temperature Range|OT temperature set to 17-19 degree celsius
15775047|NCT04654416|Drug|Corticosteroid with or without colchicine|We describe the clinical outcome of patients treated with corticosteroid and colchicine
15775048|NCT04654403|Drug|Camrelizumab|Eligible patients receive Camrelizumab 200 mg by intravenous (iv.) infusion every 2 weeks (Q2W) for 4 cycles.Imaging will be performed 2-3 weeks after the 4th Camrelizumab administration.Patients who achieve PD and SD will be not included in the data statistics of this trial.The follow-up treatment according to investigator's and patients's choice(chemotherapy, Camrelizumab plus chemotherapy or Camrelizumab monotherapy).Other patients whose BOR is in remission (CR+PR) will be randomly assigned in a 1:1 ratio to receive Camrelizumab (200 mg every 2 weeks), or Camrelizumab plus chemotherapy(Camrelizumab 200 mg every 3 weeks,docetaxel 75mg/m2/d plus cisplatin 75 mg/m2/d on day 1 every 3 weeks),)Treatment will continue until confirmed radiographic progression,unacceptable toxicity, investigator or patient decision to withdraw, nonadherence to treatment or trial procedures or completion of 16 cycles of Camrelizumab (approximately 1 years).
15775049|NCT04654390|Drug|DWP16001 Amg|Tablets, Orally, Once daily
15775050|NCT04654377|Other|Personalised education|Patients will be explained about their disease and possible outcomes based on clinical, biochemical and imaging data.
15775051|NCT04654351|Drug|TAK-667|TAK-667 single SC administration
15775052|NCT04654338|Radiation|SABR + HDR|One SABR treatment + one HDR brachytherapy treatment
15775053|NCT04654325|Diagnostic Test|conjunctival swab|Patients will have conjunctival swab for SARS-CV-2 genome detection
15775054|NCT04654312|Drug|Hydrochlorothiazide|Please see arm descriptions
15775055|NCT04654312|Drug|Placebo|Please see arm descriptions
15775056|NCT04654299|Procedure|External biliary stent|The biliary stent consisted of a multi-perforated, natural rubber tube, measuring 3.5 mm in diameter, that we placed transanastomotically, with exteriorization sited at 20 cm utilizing the Witzel jejunostomy approach
15775057|NCT04654286|Procedure|Nerve transfer procedure|"Identification of potential donor nerves: phrenic nerve, accessory nerve, intercostal nerve, motor branch nerve innervating long head of triceps muscle, motor branch of ulnar nerve innervating flexor carpi ulnaris (FCU) muscle, and motor branch of median nerve innervating flexor carpi radialis (FCR) muscle.
~Donor nerve is checked for its viability with an electric stimulator during surgery
~Viable donor nerve is dissected, transferred to the recipient area, and sutured with end-to-end anastomosis."
15775058|NCT04654286|Procedure|Nerve transfer with HAM-AdMSC composite wrapping|When the nerve transfer procedure is finished, the end-to-end anastomosis is wrapped by a composite consisted of human amniotic membrane and allogeneic adipose-derived mesenchymal stem cells (HAM-AdMSC)
15775088|NCT04654000|Procedure|Sham-apheresis|Sham-apheresis is performed with the same automated monitor (Plasauto, HemaT company). Extracted plasma is not treated through the secondary filter (Rheofilter) and return to the patient.
15775089|NCT04653987|Procedure|Percutaneous biliary drainage|
15775146|NCT04653441|Behavioral|Child-Caregiver-Advocacy-Resilience [ChildCARE] intervention|"The proposed multimodal Child Caregiver-Advocacy-Resilience intervention (ChildCARE) will include three integrated components: the individual child (peer-group activities), family (caregiver parenting skill training), and the local community (community advocacy)."
15775147|NCT04653428|Device|Interventional treatment of tricuspid regurgitation|Interventional treatment for tricuspid regurgitatin with CE-certified products, e.g. edge-to-edge repair
15775059|NCT04654260|Behavioral|Behavioral Therapy for Irritability in Autism|The child-focused components of BTIA are organized in modules dedicated to emotion regulation, problem solving and practice of planned steps to prevent or resolve conflicts. Each session contains a set of six to seven goals, and each goal contains a menu of techniques and activities that can be used to attain this goal. In order to administer the treatment in a flexible yet reliable manner, the therapist works collaboratively with the child and his or her parents to select activities that are perceived as relevant for attaining the session's goal. The parent-focused components of BTIA include include education about the effects of antecedents and consequences on disruptive behavior, developing strategies for reducing or altering antecedent events that may lead to disruptive reactions and helping parents to use reinforcement of competent and calm responses in potentially frustrating situations.
15775060|NCT04654260|Behavioral|Psychoeducation and Supportive Therapy (PST)|Each PST session will start with a review of events of the past week and include queries of topics such as school, interests, hobbies, and family with an overarching goal of enhancing subjective well-being. A major objective is to enables the participant to discuss his or her concerns with a therapist toward a goal of enhancing overall psychological wellbeing. Education about autism diagnosis and services is also provided to families as part of PST.
15775061|NCT04654247|Behavioral|Quality audit and feedback|Endoscopists received quality report generated by Endo.Adm.
15775062|NCT04654247|Behavioral|Control|None feedback.
15775063|NCT04654234|Device|Total body PET/CT (uExplorer)|A total-body positron emission tomography/computed tomography (PET/CT) scanner (uEXPLORER) with a 192-cm scan range was applied for cancer diagnosis, organ function assessment and treatment outcome prediction. The total-body PET scanner can acquire scans with lower administered activity or short acquisition time, total-body dynamic acquisition at a longer delayed time point, and high detectability of exiguous changes of the whole body, and tumor as well.
15775064|NCT04654221|Diagnostic Test|mGFR by iohexol clearance|Iohexol 5mL injection (300 mg iodine/mL) will be administered to all subjects to determine mGFR by iohexol clearance
15775065|NCT04654208|Drug|palbociclib|patients on palbociclib combination treatment
15775066|NCT04654195|Genetic|polymorphism analysis|DNA will be purified from whole blood samples by commercial DNA isolation kits. Genotyping and genetic polymorphism detection for some metabolic enzymes genes will be performed by real time PCR.
15775067|NCT04654195|Drug|Doxorubicin-Cyclophosphamide regimen|Treatment with a combination of Doxorubicin and Cyclophosphamide, This regimen comprises 60 mg/m² Doxorubicin and 600 mg/m² Cyclophosphamide administered intravenously on day 1 of each 21-day cycle, and repeated for a total of four cycles.
15775068|NCT04654182|Drug|Chlorhexidine Gluconate|Product used in accordance with manufacturers Hand Hygiene instructions
15775069|NCT04654169|Procedure|Ultrasound-guided IAI|Ultrasound-guided IAI was applied with a posterior glenohumeral joint in-plane injection technique.
15775070|NCT04654169|Procedure|Ultrasound-guided SSNB|Ultrasound-guided SSNB was carried out with a supraspinatus fossa level in-plane injection technique
15775071|NCT04654156|Diagnostic Test|Contrast Boost post processing technique|Contrast Enhancement Boost is a post-processing technique that uses an iodine density map generated by subtracting a pre- and post-contrast CT acquisition to artificially enhance pulmonary artery enhancement.
15775073|NCT04654130|Other|Neurofeedback|"NFB is a type of brain training in which a person is given real-time information (or feedback) from their own brain activities to help them potentially change how their brain is functioning (i.e., to work in a healthier or more effective manner). In the current study, we will implement at-home, supervised (via teleconferencing) neurofeedback sessions using the Muse headband paired with the Myndlift software application to conduct alpha-down neurofeedback once per week, for 19 weeks."
15775074|NCT04654117|Other|Consultee-centered administrative consultation|The consultee-centered administrative consultation model expressly focuses on supporting providers to increase EBP implementation within their specific setting.
15775075|NCT04654104|Other|check immune check points|we will evaluate the expression of immune check points
15775076|NCT04654091|Procedure|Cryoteraphy with liquid nitrogen|"Weekly, at each visit, before applying the treatment, a debridement of the hyperkeratotic tissue covering the wart will be performed with a scalpel handle of number 3 and a scalpel blade of number 15, and then the treatment will be applied.
~Subsequently, the application of cryotherapy with liquid nitrogen will be carried out using CryoPen b® (HO Equipment, Hhislenghien-Belgium). To analyze the homogeneous application in all the patients in the study, perform 2 applications of 15 seconds per session, with an interval of 30 seconds between each application, such and as manufacturers recommend. The number of sessions in which the product is applied will be a maximum of 5, following the procedure of previous studies."
15775077|NCT04654091|Procedure|Nitric-zinc complex|"Weekly, at each visit, before applying the treatment, a debridement of the hyperkeratotic tissue covering the wart will be performed with a scalpel handle of number 3 and a scalpel blade of number 15, and then the treatment will be applied.
~Subsequently, the application of nitric acid-zinc complex with Verrutop® (Isdin, Barcelona-Spain) will be carried out. The preparation is applied by making small touches with the applicators included in the product.
~The number of sessions in which the product is applied will be a maximum of 5, following the recommendations of the manufacturers in the product data sheet."
15775078|NCT04654078|Drug|IN-C004 with water|One time dose of IN-C004 taken with water
15775079|NCT04654078|Drug|IN-C004 without water|One time dose of IN-C004 taken without water
15775080|NCT04654078|Drug|K-CAB tab. with water|One time dose of K-CAB tab. taken with water
15775081|NCT04654065|Drug|IN-C004|One time dose of IN-C004 taken orally.
15775082|NCT04654052|Drug|Clopidogrel|Clopidogrel during 11 months
15775083|NCT04654052|Drug|Previous treatment|non-intervention
15775085|NCT04654026|Drug|Aspirin/Clopidogrel|No intervention, only observational studies
15775086|NCT04654013|Device|Spectacles|Intervention group workers receive free glasses within one week of undergoing vision assessment (April 2021). The duration of the treatment for the Intervention participants will depend on when they leave employment at the factor. If they stayed for the full duration of the trial, they will have undergone a maximum of 18 months (October 2022).
15775144|NCT04653467|Drug|Placebo|Placebo oral suspension
15775812|NCT04647877|Drug|phenytoin cream|Phenytoin cream to be applied on the neuropathic pain area
15775090|NCT04653974|Behavioral|Needle-free injection|"This study was performed among children aged 4-11 years who required dental treatment and were treated at the Department of Pedodontics, Faculty of Dentistry, Gaziosmanpasa University. A total of 70 patients were evaluated in accordance with the exclusion criteria and 56 children (31 girls and 25 boys) were included in this study. Children who needed dental treatment were randomly divided into two groups. All dental injections were administered by the same operator (MB), a pediatric dentist with two years of experience in using the Comfort-In system.
~In both groups, the children were asked to rate their pain intensity by choosing the closest statement on the Wong-Baker Pain Scale at three time points: immediately after injection (Pain 1), during treatment (Pain 2), and at the end of the treatment (Pain 3)."
15775091|NCT04653961|Device|DreaMed Advisor Pro DSS-MDI algorithm|The DreaMed Advisor Pro software is a proprietary algorithm, designed to provide a comprehensive analysis of individual diabetes data which consists of glucose levels and insulin delivery history. the Advisor Pro algorithm identifies glucose patterns and their possible causes, which may hamper the patient's glucose control, and recommend on adjustment to the patient-specific insulin treatment profiles as well as suggestions for personalized diabetes management tips (such as timing of meal boluses, bolus delivery compliance and personalized glucose targets).
15775092|NCT04653935|Behavioral|Self-management app with all intervention components|A behavioural self-management app, containing multiple cognitive- and behavioural self-management techniques for those living with Sjögren's syndrome. The intervention is comprised of several components and modules that holistically target several key symptoms: fatigue, sleep disturbances, chronic pain, and dryness. The app has been developed using user-centred methods, and is theory- and evidence-based.
15775093|NCT04653935|Behavioral|Self-management app with Information component only|self-management app for those with Sjögren's syndrome, includes Symptom and Lifestyle Information, only.
15775094|NCT04653922|Device|LinkCor Bioengineered Corneal Implant|Intrastromal implantation of a bioengineered corneal equivalent device
15775095|NCT04653909|Other|Rehabilitation|The abdominal and back strengthening exercises on the mat, the open-closed perturbation training in sitting and standing positions for trunk control. Functional exercises were performed in the same positions for simulating daily living activities. The stretching and strengthening exercises were applied to her scoliosis and also given trunk orthoses.
15775096|NCT04653896|Device|Keeogo|The Keeogo is the only commercially available (in Canada) robotic exoskeleton for a non-paralyzed population who can stand and initiate a stepping action, but have impaired mobility for functional tasks. Keeogo provides active assistance during stance and swing phases and assists users to perform functional mobility tasks including walking, stair climbing, sit-to-stand, bending, squatting, and kneeling.
15775097|NCT04653870|Other|cyriax manipulation lumber|"In group A patients were treated with conservative therapy (hot pack, Kaltenborn soft tissue techniques and home plan) and Cyriax manipulation.
~Exercises (Guided low back exercises, 3-5times/day). Ankle pumping (5-10 repetition with 15-20 second hold), Quads Isometric (5-10 repetition with 15-20 second hold), Hams & Calf stretching (5-10 repetition with 15-20 second hold), Bridging (5-10 repetition with 15-20 second hold), Prone Back extension (10 repetition) Precaution Prevent yourself from sitting low on ground, Sitting with support will be directed and be careful during driving and ascending stairs.
~Cyriax Manipulation: 2-3 repetitions/session, 2 session/week Lumbar spinal manipulation Rotation Techniques Lumbar spinal manipulation Extension Techniques Lumbar spinal manipulation Antideviation Techniques total of 4 session were given. 2 session/week."
15775098|NCT04653870|Other|lumber decompression|"Group B: In group B patients were treated with conservative therapy (hot pack, Kaltenborn soft tissue techniques and home plan) and Decompression Session.
~Conservative therapy: Same as Group A
~Lumbar spine decompression:
~30 Minutes Session (generalized time for every one) . On the account of MRI description level is recommended and acknowledged by MRI the level of disc protrusion, decompression is operated. Patient is lying on table facing upward. For locking of the patient's body it was secured by pelvis and thoracic straps. One part of the decompression table is immobile other is movable. Bottom extreme part of the table is mobile.
~Estimation of weight of patient is first thing to do. We calculated it by division of whole weight by 5 and that 5th segment of weight was utilized as an interventional pound for decompression. ."
15775099|NCT04653831|Drug|Pirfenidone|Treatment with Pirfenidone as mentioned in the experimental arm description.
15775100|NCT04653831|Other|Standard of care|Treatment with SoC as mentioned in the control arm description.
15775101|NCT04653818|Drug|Velpatasvir/Sofosbuvir|sofosbuvir / velpatasvir will be given for 12 weeks aiming to eradicate HCV. Ribavirin will be added for Child-Pugh B patients or treatment will be extended for 24 weeks for those who are Ribavirin intolerant.
15775102|NCT04653805|Other|Current clinical practice in primary care of patients with type 2 diabetes mellitus|
15775103|NCT04653792|Drug|Pregabalin 75mg|75 mg capsule
15775104|NCT04653792|Device|Placebo|75 mg
15775105|NCT04653779|Drug|Evogliptin 5mg/Metformin 1000mg|Size reduction of a tablet formulation
15775106|NCT04653766|Drug|Ir-CPI - Dose 1|6 participants received a single intravenous dose of 1.5 mg/kg of Ir-CPI during 6 hours
15775107|NCT04653766|Drug|Ir-CPI - Dose 2|6 participants received a single intravenous dose of 3.0 mg/kg of Ir-CPI during 6 hours
15775108|NCT04653766|Drug|Ir-CPI - Dose 3|6 participants received a single intravenous dose of 6.0 mg/kg of Ir-CPI during 6 hours
15775109|NCT04653766|Drug|Ir-CPI - Dose 4|6 participants received a single intravenous dose of 9.0 mg/kg of Ir-CPI during 6 hours
15775110|NCT04653766|Drug|Placebo|For each dose group, 2 additional participants received a single intravenous dose of placebo during 6 hours (8 in total).
15775111|NCT04653753|Device|kneeSOFT500|At least 30 patients (15 patients in the orthosis group and 15 patients in the control group) will be included. Patients included in the orthosis group will use the device during sports sessions while patients included in the control group will not use a knee support device.
15775112|NCT04653740|Procedure|specimen sample collection|"Before and during treatment, and at progression, collection of :
~Blood
~Exhaled air
~Saliva
~Sweat
~Tears
~Urine"
15775113|NCT04653727|Other|Cross-sectional survey|No intervention.
15775145|NCT04653454|Device|Continuous Glucose Monitor (CGM)|CGM data will be downloaded prior to discharge and it will be compared with hospital glucometer readings taken at the same time.
15775148|NCT04653415|Drug|Gabapentin 300mg|"The study group will receive as pre-emptive analgesia a single dose of 300 mg oral gabapentin and 125 mg intravenous methylprednisolone."
15775114|NCT04653714|Procedure|Scaling and root planing|"Patients with periodontitis in the test group will be treated by conventional non-surgical root debridement and in the control group by low-intensive supragingival plaque removal with mechanical brush and professional tooth paste only.
~Patients with gingivitis in the test group will be treated with supragingival debridement and with probiotic lozenges with strains of Lactobacillus brevis and Lactobacillus plantarum once a day for 3 months and in the control group by low-intensive supragingival plaque removal, as a placebo treatment, and placebo probiotics lozenges."
15775115|NCT04653701|Combination Product|Chemoembolization with preloaded microparticles 100 micron and reflux control microcatheter|We will perform chemoembolization technique in those patients (during 1 year) with indications for this treatment in relation with guidelines (early and intermediate hepatocellular carcinoma). Specific microcatheter and microparticles will be use (Mentioned above)
15775116|NCT04653688|Device|The FeetMe® Evaluation|The FeetMe® Evaluation device is a medical device (class Im CE 0459) for ambulatory gait analysis, consisting of a pair of connected insoles and an Android mobile application.
15775117|NCT04653688|Device|the PKG® Watch,|The PKG® provides continuous, objective, ambulatory assessment of the treatable and disabling symptoms of Parkinson's disease including tremor, bradykinesia and dyskinesia. The PKG® system consists of a wrist-worn movement recording device known as the PKG® Watch,
15775118|NCT04653688|Radiation|MRI|"an anatomical 3D T1-weigthed gradient-echo sequence (1mm isotropic):
~anatomical registration
~automated segmentation
~volumetric
~texture analysis"
15775119|NCT04653688|Radiation|DaTSCAN|"quantify nigrostriatal dopaminergic depletion
~correlate its impact on the type and severity of gait disorders in Parkinson's disease."
15775120|NCT04653662|Device|Earol|Treated with Earol on both ears and subsequent removal after 6 days of application
15775121|NCT04653649|Biological|HSP-CAR30|Anti-CD30 CAR T-cells
15775122|NCT04653636|Other|Arthrographic distension|"The treatment consists in one to three shoulder joint capsule arthrographic distension. It consists after local anesthesia, in an injection under pressure of xylocaine 1% and physiological serum in the glenohumeral joint associated with an ampoule of corticosteroids (Betamethasone or Triamcinolone hexacetonide ) at the end of the operation.
~first arthrographic distension is performed under scopic guidance
~second and/or third arthrographic distension are performed under ultrasound guidance"
15775123|NCT04653636|Other|Immediate joint mobilization|"This procedure was associated with intensive (immediate mobilization, recovery of maximum amplitudes by the physiotherapist and on arthro-motor).
~Physical treatment aimed at rapid amplitude gain and is started immediately after the arthrographic distension, under the effect of local anesthesia. It is at best continued daily at a rate of 2 to 8 hours per day for one to 2 weeks. Depending on the effect obtained on pain and the daily progression of rehabilitation, arthrographic distension may be repeated once or twice during the mobilization period."
15775124|NCT04653623|Procedure|High tibial osteotomy|Treatment option for medial compartment osteoarthritis of knee
15775125|NCT04653623|Drug|Tranexamic acid|Medication used to treat or prevent excessive blood loss from major trauma, postpartum bleeding, surgery, tooth removal, nosebleeds, and heavy menstruation
15775126|NCT04653597|Procedure|Close monitoring|surveillance every 30 minutes of blood pressure, SpO2, respiratory rate, heart rate and GCS until the patient recovers a GCS>8 or responds adequately to a simple order
15775127|NCT04653597|Procedure|Endotracheal intubation|invasive airway management in order to avoid risk of pulmonary aspiration
15775128|NCT04653571|Other|CASPR2 encephalitis|Defining the initial clinical symptoms and those leading to the diagnosis of CASPR2 antibody associated encephalitis. For that, we will investigate the initial cognitive status, the initial neuropsychological investigations the clinical presentation of the first seizures, and the prodromes assessed by patients at the beginning of their disease. We will also look at the initial EEG records, in order to acknowledge whether the initial cognitive symptoms may be due to unseen seizures.
15775129|NCT04653545|Diagnostic Test|HbA1c|"Blood will be taken as per requirement for patients being admitted to hospital. A small sample will be sent to the biochemistry department for measurement of HbA1 (by HPLC method).
~All patients who are diagnosed with diabetes (or known to have diabetes) will have a foot examination and retinal and renal screening and cardiovascular assessment for diabetes complications."
15775130|NCT04653532|Behavioral|Exercise Programme and Counselling|A 6 month exercise and physical activity programme supported by an exercise specialist
15775131|NCT04653532|Device|Polar Ignite and App|A fitness watch that links to a mobile phone application (App) which enables the exercise specialist to provide greater support and feedback throughout the programme
15775132|NCT04653519|Device|Virtually guided minimally invasive preparation|Intraoral virtually guided minimally invasive design with an occlusal reduction of 1.5mm, axial reduction will be performed with 6 degrees axial taper and a circumferential chamfer margin of 0.5mm in width and 0.5mm coronal to the gingival margin. A milled guiding occlusal resin template of the teeth will be checked for fitting then fixed using spot etching and will be used to guide the amount of axial reductions and taper degree.
15775133|NCT04653506|Drug|Paracetamol 1000 mg|Women participating in the study will receive postpartum analgesia immediately while reporting pain requiring analgesia, by envelope contains paracetamol 1000 mg or ibuprofen 400 mg
15775134|NCT04653506|Drug|Ibuprofen 400 mg|Women participating in the study will receive postpartum analgesia immediately while reporting pain requiring analgesia, by envelope contains paracetamol 1000 mg or ibuprofen 400 mg
15775135|NCT04653493|Biological|CD19 CAR engineered autologous T-cells|"Given IV
~Following preconditioning with lymphodepleting chemotherapy (cyclophosphamide and fludarabine) patients will be treated with CD19 Chimeric Antigen Receptor (CAR) T cells as a single or split dose (day 0, 1 and 2, CAR cells will be intravenously infused at the 10%, 30% and 60% ratio respectively). Dosing of CD19 CAR-T cells will follow a dose-escalation schema, with dose changes based on dose-limiting toxicities."
15775136|NCT04653493|Drug|Cyclophosphamide|Given IV
15775137|NCT04653493|Drug|Fludarabine|Given IV
15775138|NCT04653493|Drug|Mesna|Given IV
15775139|NCT04653480|Drug|Surufatinib|250mg per oral, once daily
15775140|NCT04653480|Drug|Toripalimab|3mg/kg IV, once every 2 weeks
15775141|NCT04653480|Drug|chemotherapy|oxaliplatin or irinotecan based regimens, according to the first line treatment
15775142|NCT04653467|Drug|GLPG4399 oral suspension|GLPG4399 for oral administration
15775143|NCT04653467|Drug|GLPG4399 capsules|GLPG4399 for oral administration
15775150|NCT04653415|Drug|Tablet|The controls group will receive placebo orally - a tablet without any pharmacological properties, intravenously - normal saline solution
15775151|NCT04653415|Drug|Normal Saline 10 mL Injection|The controls group will receive placebo orally - a tablet without any pharmacological properties, intravenously - normal saline solution
15775152|NCT04653402|Device|Hydrocelectomy surgery|The standardized hydrocelectomy operation i.e. Eversion of the TVT sac
15775153|NCT04653389|Drug|Sintilimab Injection|Sintilimab Injection is used as neoadjuvant therapy and adjuvant therapy.
15775154|NCT04653389|Drug|TACE|The first TACE and Sintilimab Injection will be initiated simultaneously.
15775155|NCT04653389|Radiation|Radiotherapy|Use Cone Beam computor tomography(CBCT) locates the lession before the therapy.
15775156|NCT04653376|Procedure|Tonsillectomy surgery|The tonsillectomy procedure was performed under general anesthesia using the classical dissection method. Extracted tonsil tissue samples were sent to the medical genetics department in tubes to investigate the ER stress and apoptosis.
15775157|NCT04653363|Other|assessments|All assesments will be done by the first physiotherapist. But only 3m backward test will be done by the first and second physiotherapist in the first day and second day.
15775160|NCT04653337|Combination Product|Robot-assisted rTMS combined with serotonin-norepinephrine reuptake inhibitors(SNRIs)|Subjects will receive a 15-day trial of robot-assisted rTMS combined with SNRIs（Venlafaxine or Duloxetine）
15775161|NCT04653337|Combination Product|Conventional rTMS combined with serotonin-norepinephrine reuptake inhibitors(SNRIs)|Subjects will receive a 15-day trial of conventional rTMS combined with SNRIs（Venlafaxine or Duloxetine）
15775162|NCT04653337|Combination Product|Sham rTMS combined with serotonin-norepinephrine reuptake inhibitors(SNRIs)|Subjects will receive a 15-day trial of conventional rTMS combined with SNRIs（Venlafaxine or Duloxetine）
15775163|NCT04653311|Device|Endomina®|Endoscopic sleeve gastroplasty (Endomina) at J0 with multidisciplinary follow-up for 1 year
15775164|NCT04653298|Other|Evaluation of quality of life, comorbidities and return to work status|Quality of life will be evaluated thanks to several methods: Short Form 36, EQ 5D 5L and return to work status Questionnaires will be evaluated through postal and phone call at least 12 months after ECMO.
15775168|NCT04653272|Other|Questionnaire|Patients will be evaluated identically to routine care with reference tests (Lysholm-Tegner, and Knee injury and Osteoarthritis Outcome Score (KOSS) and, IKDC (Evaluation of knee ligament injuries). This is filled in without any external help. The questionnaire includes the Lysholm-Tegner (young adult group), IKDC and KOOS scores (young and senior adult groups).
15775169|NCT04653259|Other|LYFE MD app|"LyfeMD app is a digital health platform for patients living with both Crohn's disease (CD) and Ulcerative colitis (UC). LyfeMD is meant to help people live and thrive while managing their inflammatory disease with holistic, easy-to-implement, evidence based lifestyle therapies. LyfeMD is one app with multiple features - ranging from customized diet using anti-inflammatory principles identified from recent research, exercise plans to mindfulness and stress reduction programs. It helps patients make therapeutic diet choices to treat inflammation and provides stress reduction strategies when they feel unwell. The LyfeMD app also supports patients to maintain remission even when they're feeling well with trusted resources designed to keep them symptom free.
~In addition to delivering personalized and interactive support, the app uses behaviour science to help patients change their habits, improve their health and reduce the burden IBD places on their lives."
15775170|NCT04653246|Drug|Isatuximab|Via IV at predetermined dosage and predetermined days during each cycle
15775171|NCT04653246|Drug|Lenalidomide|Oral, predetermined dosage and predetermined days during each cycle
15775172|NCT04653246|Drug|Bortezomib Injection|SQ Oral, predetermined dosage and predetermined days during each cycle
15775173|NCT04653246|Drug|Dexamethasone|IV or Oral predetermined dosage and predetermined days during each cycle
15775174|NCT04653233|Device|3D Systems Touch Haptic Simulator|This simulator is computer-aided and allows us to see this application on the computer screen while practicing with a haptic arm. It gives real-like feedback in hand manipulations. The simulator has a choice of 45 minutes of full instruction, 5 minutes of haptic arm only, or the option.
15775175|NCT04653220|Other|Control 1|25g glucose dissolve in 250ml of water
15775176|NCT04653220|Other|Control 2|25g glucose dissolve in 250ml of water
15775177|NCT04653220|Other|Standard Crokao|Standard Crokao containing 25g of available carbohydrate
15775178|NCT04653220|Other|Low sugar variant 1|Low sugar variant 1 containing 25g of available carbohydrate
15775179|NCT04653220|Other|Low sugar variant 2|Low sugar variant 2 containing 25g of available carbohydrate
15775180|NCT04653220|Other|Low sugar variant 3|Low sugar variant 3 containing 25g of available carbohydrate
15775181|NCT04653220|Other|Low sugar variant 4|Low sugar variant 4 containing 25g of available carbohydrate
15775182|NCT04653220|Other|Low sugar variant 5|Low sugar variant 5 containing 25g of available carbohydrate
15775183|NCT04653207|Other|Glucose Solution 1|50g glucose dissolve in 300ml of water
15775184|NCT04653207|Other|Glucose Solution 2|50g glucose dissolve in 300ml of water
15775185|NCT04653207|Other|Glucose Solution 3|50g glucose dissolve in 300ml of water
15775186|NCT04653207|Other|Sucrose/Isomaltulose 100:0|50g sucrose dissolve in 300ml of water
15775187|NCT04653207|Other|Sucrose/Isomaltulose 0:100|50g isomaltulose dissolve in 300ml of water
15775188|NCT04653207|Other|Sucrose/Isomaltulose 50:50|25g sucrose and 25g isomaltulose dissolve in 300ml of water
15775189|NCT04653207|Other|Sucrose/Isomaltulose 60:40|30g sucrose and 20g isomaltulose dissolve in 300ml of water
15775190|NCT04653207|Other|Sucrose/Isomaltulose 70:30|35g sucrose and 15g isomaltulose dissolve in 300ml of water
15775191|NCT04653207|Other|Sucrose/Isomaltulose 80:20|40g sucrose and 10g isomaltulose dissolve in 300ml of water
15775192|NCT04653194|Drug|Biktarvy|Combination single tablet anti-retroviral therapy: bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg
15775193|NCT04653194|Drug|Symtuza|Combination single tablet anti-retroviral therapy: darunavir 800mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg
15775194|NCT04653181|Drug|Ferric carboxymaltose|Iron-arm treated with Ferric carboxymaltose, non-iron arm without
15775195|NCT04653168|Drug|LY3041658|Administered SC
15775196|NCT04653155|Behavioral|Cognitive behavioural therapy for insomnia|Cognitive behavioural therapy for insomnia
15775197|NCT04653142|Drug|BI 765063|BI 765063
15775198|NCT04653142|Drug|BI 754091|BI 754091
15775199|NCT04653129|Procedure|Autologous Fat Grafting|"The fat grafts will be harvested from the abdomen or lateral thighs in a closed sterile system, then prepared according to Coleman guidelines. The blood and oil layers are then separated from the adipose tissue.
~The lipoaspirate will be injected based on a technique described by Vaienti et al, by 17-gaug cannula which will be inserted through the skin around the main incision at the nerve repair site, and the fat graft will be injected after closure of the skin."
15775200|NCT04653129|Procedure|Primary Nerve Repair|Standard Epineural nerve repairs will be performed with 9/0 nylon sutures, under magnification by an operating microscope.
15775201|NCT04653103|Procedure|Liver biopsy|Biopsy of the liver to assess for Non-alcoholic steatohepatitis
15775202|NCT04653090|Diagnostic Test|Xray|Hip AP Xray
15775203|NCT04653077|Other|stem cells|Intravenous and Intrathecal transplantation of specific populations of purified bone marrow-derived stem cells and mesenchymal stem cells.
15775204|NCT04653064|Behavioral|Placebo Cream|Approximately 1 teaspoon of exfoliating skin scrub delivered approximately 5 minutes prior to pain tasks will coincide with verbal descriptors of the cream as being analgesic.
15775205|NCT04653064|Behavioral|Control Cream|Approximately 1 teaspoon of exfoliating skin scrub delivered approximately 5 minutes prior to pain tasks will coincide with verbal descriptors of the cream as one of no effect.
15775206|NCT04653038|Drug|MGD013|A fixed dose of MGD013 600mg IV Q2W will be administered to subjects
15775207|NCT04653025|Device|Implant placement|After tooth extraction implants were placed either immediate or delayed approach
15775208|NCT04653012|Device|Intracranial macro-microelectrode recording|Additionnally to clinical macroelectrodes, Benkhe-Fried depth macro-microelectrodes will be implanted and recorded during the pre-surgical investigation of epileptic patients
15775209|NCT04652999|Behavioral|Muscle Relaxation with Guided Imagery|Relaxation intervention session begins with diaphragmatic breathing, followed by Jacobson's progressive muscle relaxation, which involves the contraction and subsequent relaxation of the 16 muscle groups of the body (forearm, arm, upper forehead, eye, mouth, jaw and throat, neck, shoulder, chest, stomach, thigh, leg and foot). The contraction is performed for 7 seconds while the relaxation lasts for about 40 to 50 seconds. The relaxation of the foot muscle group is only performed on the healthy foot, because dressing and bandages may bandage the foot with the DFU, which together with the typical joint stiffness of the diabetic foot, make it difficult to perform. After muscle relaxation, begins the guided imagery focused on DFU healing. The patient is instructed to think about his/her current state of health and to imagine the DFU as a dark area and the healing relaxation as a light associated to pleasant sensations, which will focus on the foot with DFU to heal it.
15775210|NCT04652999|Behavioral|Neutral Guided Imagery|This placebo consists on neutral guided imagery focused on themes of the patient's daily life before having DFU. Each session has a theme associated with the patient's life - family, work, friends and leisure. Initially, the patient is asked to think about an event related to the theme of the session of his/her choice, be it positive or negative, which occurred before patient has the current DFU. Then, questions are asked which allow a more detailed reconstruction of the event and the patient is asked to imagine according only to the instructions given. When the whole episode is remembered, the patient is asked to tell what he or she imagined/remembered in each of the questions given.
15775211|NCT04652960|Drug|Duvelisib|Given PO
15775212|NCT04652960|Biological|Nivolumab|Given IV
15775213|NCT04652947|Diagnostic Test|MRI diagnostic|no intervention, patient only have MRI
15775214|NCT04652934|Other|Neurodynamic|The Upper Limb Neurodynamic Test (ULNT1) technique described by Butler will be performed on the affected limb. This technique consists of performing shoulder depression, 90º shoulder abduction, hand, wrist and forearm in a neutral position, external rotation of the shoulder and extension of the elbow. After positioning the limb in this position, wrist flexion-extension movements will be performed smoothly and rhythmically of 20 movements every minute, for 3 minutes, three times per session with 1 minute of rest between each series.
15775215|NCT04652934|Other|Mimic group|The protocol used by Beneciuk et al. Will be used. This intervention consists of imitating NM without stressing the nervous system. It will be carried out as follow: a neutral cervical position will be maintained (0º of cervical inclination), 45º of shoulder abduction without depression, 45º of external rotation of the shoulder combined with 45º of elbow flexion with the forearm in pronation. Afterwards, 10 wrist flexion-extension movements will be performed at a rate of 6 seconds per cycle (3 seconds of flexion and 3 seconds of extension). The resistance that you will feel will stabilize when you change motion. Once the 10 cycles of movements have been carried out, a wrist flexion will be maintained for 10 seconds.
15775216|NCT04652921|Dietary Supplement|Creatine-guanidinoacetic acid|A dietary supplement provided as powder dissolved in a glass of water
15775217|NCT04652921|Other|Inulin|A dietary supplement provided as powder dissolved in a glass of water
15775250|NCT04652687|Biological|VIA Disc NP|VIA Disc NP - Allograft tissue injection
15845499|NCT04079296|Biological|ASP7517|Intravenous (IV)
15775218|NCT04652908|Biological|Placental Mesenchymal Stem Cells seeded on a commercially available dural graft extracellular matrix|As in the current standard fetal surgery, under sonographic guidance, initial uterine entry will be accomplished by uterine stapling device or similar. The fetus will be given an intramuscular injection of pain medications and paralytic. The myelomeningocele will be closed in a standardized manner under magnification. As in the standard fetal operation, the spinal cord will be dissected from surrounding tissue and allowed to drop into the spinal canal. The PMSC-ECM product will then be tailored to the size of the spinal cord and applied topically, cell side down. The PMSC-ECM product will be sutured in place to the dura. Finally, the fetal skin will be closed in the standard fashion. The amniotic fluid volume will be replaced and antibiotics will be added. The uterus will be closed. The abdominal fascial layer and skin will be closed in routine fashion.
15775219|NCT04652908|Other|Untreated contemporaneous cohort|The addition of a non-PMSC treated cohort, the untreated contemporaneous cohort, has been added at the request of the FDA to provide contemporaneous patients for validation of the continued relevance of use of the outcomes of the MOMS trial as the comparison arm for the Phase 2a portion of the study.
15775222|NCT04652869|Device|Transcranial direct current stimulation|Transcranial direct current stimulation targeting the dorsolateral prefrontal cortex
15775223|NCT04652869|Behavioral|Mindfulness|Mindfulness is a type of meditation in which you focus on being intensely aware of what you're sensing and feeling in the moment, without interpretation or judgment.
15775224|NCT04652856|Device|Electrical Brain Stimulation|Electrical Brain Stimulation (EBS) will be used to disrupt local neural activity in inferior temporal regions (ITC), parahippocampal cortex (PHC), the hippocampus, and control regions. The effects of EBS will be examined on attention and eye movement behavior, and all participants will receive both EBS and sham electrical brain stimulation.
15775225|NCT04652856|Device|Sham Electrical Brain Stimulation|Sham electrical brain stimulation (SEBS) will be applied to inferior temporal regions (ITC), parahippocampal cortex (PHC), the hippocampus, and control regions. The effects of SEBS will be examined on attention and eye movement behavior, and all participants will receive both SEBS and EBS.
15775226|NCT04652843|Procedure|Rectosignoidoscopy|Rectosignoidoscopy for colonic biospsies collection
15775227|NCT04652843|Procedure|Coloscopy|Coloscopy for colonic biospsies collection
15775228|NCT04652830|Behavioral|Naprapathy training|Active training aimed at strengthening the abdominal muscles
15775229|NCT04652830|Other|Control group|No change of daily routines in regard to training
15775230|NCT04652817|Device|MMI-22-04-2019|A cross-linked form of the Hyaluronic Acid is used in intradermal injection to augment the labia majora area.
15775231|NCT04652804|Behavioral|Low intensity HCV treatment adherence support|A 28-day supply of medication will be dispensed to participants at entry, 4 weeks, and 8 weeks. Participants will receive standard adherence counseling at entry and every refill pickup/home or field delivery. Participants will have access to all of the services available at the ICC including facilitated linkage to referrals as needed. Site staff will routinely track clients who miss refill appointments in real-time using standard tracking measurements
15775232|NCT04652804|Behavioral|Medium intensity HCV treatment adherence support|The medium intensity intervention will include standard of care dispensation of a 28-day supply of medication at entry, 4 weeks and 8 weeks. Participants will be assigned to a patient navigator (PN) and receive tailored patient navigation support for medication reminders, picking up medication refills (or home or field delivery of study medications), overcoming barriers as well as service linkage. Participant will be contacted by the PN at least once every two weeks.
15775233|NCT04652804|Behavioral|High intensity HCV treatment adherence support|The high intensity intervention will involve patient-centered DOT with flexibility in terms of the frequency of pickup and the site of DOT (ICC, field-based) with a minimum of at least 1 observed dose per week. Participants in this arm will also receive PN support for overcoming barriers and service linkage similar to participants in Arm 2. The main differences between Arms 2 and 3 are: (i) medications will not be dispensed for more than one week at a time (to coincide with opioid agonist therapy (OAT) dosing, where applicable); and (ii) ≥1 dose/week will be observed.
15775234|NCT04652765|Drug|Camostat Mesilate|Camostat 600mg by mouth four times a day, for a total of 7 days
15775235|NCT04652765|Drug|Bicalutamide 150 mg|Bicalutamide 150mg by mouth once daily, for a total of 7 days
15775236|NCT04652752|Device|CONNETTIVINA HI TECH patch|It is a medical device for topical application in the form of a patch with adhesive transparent polyurethane edge and a central pad impregnated with a solution of hyaluronic acid sodium salt, able to create a hydrating environment, such as to favor the natural healing process of tissue repair in case of bruises, abrasions, small cuts, superficial wounds, burns
15775237|NCT04652739|Drug|Lycopene Softgel, 10 Mg|Patients were given 10 mg of lycopene softgel capsules once daily for two months. The active ingredient in each capsule consists of 10 mg lycopene from natural tomato extract.
15775238|NCT04652739|Drug|Prednisolone|Patients were given 40 mg of prednisolone tablets once daily in the morning for one month, afterwards, the dose was tapered along the following month. Incremental reduction of 10 mg each week for the first three weeks, followed by 5 mg reduction in the last week, was the tapering protocol in this study. The active ingredient in each tablet consists of Prednisolone metasulfobenzoate sodium 31.44 mg (equivalent to 20 mg of Prednisolone).
15775241|NCT04652713|Other|Protein-rich breakfast|"High protein yoghurt containing approx. 10 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) yoghurt with 40 g oats for breakfast.
~1 glas of water (150 ml)"
15775242|NCT04652713|Other|Carbohydrate-rich breakfast|"Low protein breakfast containing approx. 2 g protein per 100 g. Participants will be asked to consume ~60 g bread, 20 g jam and 250 ml juice for breakfast.
~1 glas of water (150 ml)"
15775243|NCT04652713|Other|No breakfast|1 glas of water (150 ml)
15775813|NCT04647877|Other|Placebo cream|Placebo cream to be applied on the neuropathic pain area
15775251|NCT04652687|Drug|Transforaminal Epidural steroid injection|epidural injection of steroid into the affected area of low back pain
15775252|NCT04652687|Behavioral|Lifestyle modification|physician instructed changes to patient's daily activities to alleviate low back pain
15775253|NCT04652687|Other|Physical therapy|Physician ordered physical therapy and exercises to alleviate low back pain
15775254|NCT04652674|Behavioral|Telemedicine visit|A postoperative visit with the patient's surgeon conducted remotely via audio/video smartphone app
15775255|NCT04652674|Behavioral|In-person postoperative visit|A standard-of-care in-person postoperatively visit with the patient's surgeon
15775256|NCT04652661|Drug|Dexmedetomidine|30 children will be sedated with 2 μg/kg intranasal DEX.
15775257|NCT04652661|Drug|Midazolam|30 children will be sedated with 0.3 mg/kg intranasal midazolam.
15775258|NCT04652648|Drug|Hydroxychloroquine|Randomization was 2:1 to HCQ 200 mg BID or 41 observation for 10 days
15775259|NCT04652635|Procedure|Nail plate removal, nail bed repair|Injection of local anesthetic, removal of nail plate, inspection of nail bed, repair of nail bed with suture and/or adhesive
15775260|NCT04652622|Device|Mindful Garden|Mindful Garden is an interactive digital behavior modification platform utilizing inbuilt sensors and screen based delivery system. The platform delivers calming visual output of real nature video layered with hyper-real animations of growing and receding flowers and butterflies in flight in a volume directly responsive to measured patient activity. Patient movement and vocalization are the surrogate markers for agitation and using proprietary algorithms drive onscreen content.
15775261|NCT04652609|Other|PRESIONA|Aerobic and strength exercise combined with restricction blood flow cuffs during chemotherapy treatment
15775262|NCT04652596|Other|Produce prescription program|A monthly $150 stipend will be provided to participants for 6 consecutive months to purchase fresh food items at mobile markets and independent farmers markets across Boston.
15775263|NCT04652596|Other|Grocery store gift cards|A monthly value of $150 in grocery store gift cards redeemable at conventional grocery stores will be provided to participants for 6 consecutive months.
15775264|NCT04652583|Device|Earstim - Active Stimulation|Intramuscular stimulation
15775265|NCT04652583|Device|Earstim - Sham Stimulation|Sham stimulation
15775266|NCT04652570|Drug|VB119|Humanized, immunoglobin (Ig) G1 monoclonal antibody (mAb) to be administered as intravenous infusion at multiple timepoints during the study.
15775267|NCT04652557|Drug|Fampridine SR|Fampridine SR is an inhibitor of voltage gated potassium channels and is approved in Switzerland for treatment of gait problems in patients with Multiple Sclerosis (MS).
15775268|NCT04652557|Drug|Placebo|no active component
15775269|NCT04652544|Drug|Cholecalciferol (Vitamin D3)|Vi-De 3® Monthly Dose from Dr. Wild & Co. AG (Muttenz, Switzerland) is a commercially available vitamin D3 supplement.
15775270|NCT04652544|Other|Placebo|A placebo will be produced, consisting of the same ethanol solution as Vi-De 3® Monthly Dose, but without cholecalciferol.
15775271|NCT04652531|Other|Autologous extracellular vesicles from serum|Peri-wound injection of the vesicles will be performed in a sterile environment. Sterile gauze and an elastic-compression bandage will be applied.
15775272|NCT04652518|Drug|LYT-100|oral administration
15775273|NCT04652518|Other|Placebo|oral administration
15775274|NCT04652505|Other|Questionnaire Administration|Complete questionnaires
15775275|NCT04652492|Drug|Tislelizumab in combination with cTACE|On-demanded cTACE in combined with tislelizumab (200mg q3w ivgtt on day 4 of each 21-day cycle)
15775276|NCT04652479|Drug|Avexitide|Avexitide (exendin 9-39) is a competitive antagonist of GLP-1 at its receptor
15775277|NCT04652466|Device|farukcicekci2|To compare the incidence of for I-Gel malposition between USG and FOB, and to find the correlation between I-Gel's USG and FOB-detected malposition
15775278|NCT04652453|Other|Geriatrics Bundle|Enrolled participants in the intervention arm will receive all 3 bundle components: occupational therapy (in addition to physical therapy) upon enrollment in the ICU, a portable amplifying device upon enrollment in the ICU, and a de-prescribing intervention by the ICU pharmacist (in conjunction with the medical team) upon ICU-to-floor transfer.
15775279|NCT04652440|Drug|PD-1 monoclonal antibody, Tislelizumab.|The enrolled patients received intravenous injections of PD-1 monoclonal antibody (Tislelizumab 200mg) on the 1 day before radiofrequency ablation treatment and 21(±7) days, 42(+7) and 63(+7) after treatment.
15775280|NCT04652440|Procedure|Radiofequencey ablation|The enrolled patients received primary radiofrequency ablation before PD-1 treatment.
15775281|NCT04652427|Drug|Dexmedetomidine Hydrochloride 0.1 MG/ML|At least 15 min prior to anesthesia is sedated by the study drug given according to the administration protocol, an alert/sedative score (OAA/S) is performed at the end of the drug load dose administration, and then the maintenance-giving phase is then performed at the end of the operation with an OAA/S score every 5 min. Anestheticing can be performed after the required level of sedation has been reached. OAA/S 4 should always be maintained during drug administration.
15775282|NCT04652427|Drug|0.9% Sodium Chloride Injection|At least 15 min prior to anesthesia is sedated by the study drug given according to the administration protocol, an alert/sedative score (OAA/S) is performed at the end of the drug load dose administration, and then the maintenance-giving phase is then performed at the end of the operation with an OAA/S score every 5 min. Anestheticing can be performed after the required level of sedation has been reached. OAA/S 4 should always be maintained during drug administration.
15775283|NCT04652414|Drug|Prednisone|Prednisone 50mg will be administered enterally for 7 days.
15775284|NCT04652414|Drug|Placebo|This is a matching placebo to prednisone.
15775285|NCT04652388|Behavioral|Nutritional counseling|Nutritional counseling about mediterranean diet
15775286|NCT04652375|Other|Albumin Solution|Participants will receive Albumin solution for fluid resuscitation post-surgery.
15775287|NCT04652375|Other|Lactated Ringer's Solution|Participants will receive Lactated Ringer's solution for fluid resuscitation post-surgery.
15775324|NCT04652167|Diagnostic Test|Standard care|Standard care is the measurement of CRP (C-reactive protein) will be measured with C - reactive protein (CRP4) immunoturbidimetric assay (Tina-quant®, Roche) on Roche/Hitachi cobas© systems c701/702. Calibration is performed (Tina-quant® C - reactive protein IV) once per reagent lot and after 6 months using the same reagent lot. Quality control is required after calibration and according manufacturing instructions.
15775288|NCT04652362|Behavioral|Growth Mindset Online Single-Session Intervention|During the self-administered single session intervention participants are provided with basic information about the brain and are introduced to the concept of neuroplasticity. The concept of neuroplasticity is applied to personal traits, such as shyness, anxiety and sadness, and young people are taught that these traits are the result of thoughts and feelings in our brain and are amenable to change. Participants are presented with scientific information and research evidence to support the idea that people have the potential to change and are given vignettes from older children detailing how they have used a growth mindset to overcome difficulties. The intervention takes approximately 20-30 minutes to complete.
15775289|NCT04652362|Behavioral|Supportive Therapy Online Single-Session Intervention (Control)|The single session supportive therapy intervention was designed to be structurally comparable to the growth mindset intervention, including the same number of reading and writing activities. Participants were provided with information about emotions and the benefits of expressing emotions. Vignettes from older children described times they had shared their emotions with friends and family members.
15775290|NCT04652349|Drug|HGP1910|Take it once daily for 8 weeks orally.
15775291|NCT04652349|Drug|HCP1903|Take it once daily for 8 weeks orally.
15775292|NCT04652349|Drug|HGP1909|Take it once daily for 8 weeks orally.
15775293|NCT04652349|Drug|HGP1911|Take it once daily for 8 weeks orally.
15775294|NCT04652336|Procedure|laparoscopic sleeve gastrectomy|Comparator arm - will receive standard laparoscopic sleeve gastrectomy
15775295|NCT04652336|Procedure|ligamentum teres cardiopexy with sleeve gastrectomy|experimental arm - Ligamentum teres will be divided from umbilicus to up to umbilical fissure. The ligament will then be wrapped around lower esophagus and sutured.
15775296|NCT04652323|Drug|Biocompatibility of calcium silicate cements|The presence of inflammation, edema, necrosis, dystrophic calcification, and thickness of fibrous capsule formation was recorded by histological examination 7, 30, and 60 days after the implantation procedure of materials.
15775297|NCT04652310|Device|TFNA extended-short nail (235 mm)|The extended short version of the TFN-advanced proximal femoral nailing system (TFNA)
15775298|NCT04652310|Device|TFNA long nail (260-480mm)|The long version of the TFN-advanced proximal femoral nailing system (TFNA)
15775299|NCT04652297|Drug|HS-10356|Single dose of HS-10356
15775300|NCT04652297|Drug|Placebo|Single dose of Placebo
15775301|NCT04652297|Drug|HS-10356|Multiple doses of HS-10356
15775302|NCT04652297|Drug|Placebo|Multiple doses of Placebo
15775303|NCT04652284|Drug|Rifabutin|150 mg
15775304|NCT04652284|Drug|Amoxicillin|1000 mg
15775305|NCT04652284|Drug|Esomeprazole|40 mg
15775306|NCT04652284|Drug|Clarithromycin|500 mg
15775307|NCT04652284|Drug|Tinidazole|500 mg
15775308|NCT04652271|Procedure|Pancreatic surgery|Open, laparoscopic or robotic surgery of the pancreas
15775309|NCT04652258|Drug|Actemra|Dosage: 8mg/kg (max. 800mg) Actemra administered intravenously as an infusion over 60 min.
15775310|NCT04652245|Drug|Treatment A (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray at Visit 3|Single dose, one spray in each nostril of Dymista nasal spray, approximately 137 μg of azelastine hydrochloride and 50 μg of fluticasone propionate per actuation, at Visit 3
15775311|NCT04652245|Drug|Treatment B (Placebo): Nasal spray with no active dose (Dymista vehicle) at Visit 5|Single dose, one spray in each nostril of Placebo nasal spray at Visit 5
15775312|NCT04652245|Drug|Treatment A (Dymista): Fixed drug combination of azelastine hydrochloride and fluticasone propionate nasal spray at Visit 5|Single dose, one spray in each nostril of Dymista nasal spray, approximately 137 μg of azelastine hydrochloride and 50 μg of fluticasone propionate per actuation, at Visit 5
15775313|NCT04652245|Drug|Treatment B (Placebo): Nasal spray with no active dose (Dymista vehicle) at Visit 3|Single dose, one spray in each nostril of Placebo nasal spray, at Visit 3
15775314|NCT04652232|Other|RV3466F lotion|"Code: RV3466F Formula: MF5354
~Application modalities:
~3 times per week, in the evening, on a dry scalp 10 sprays overall hair after having achieved hair rays in order that the product is in contact with the scalp. Then massage to promote penetration of the lotion. Don't rinse.
~Shampoo should be avoided within the 2 hours after application"
15775315|NCT04652232|Other|Shampoo|"Associated neutral shampoo: Extra mild shampoo Ducray® Code: RD0057H Formula: VS4031
~Application modalities:
~as often as usual
~For the treated group only : no shampoo within the 2 hours after lotion application"
15775316|NCT04652219|Biological|gucy2c cart cells|Patients with advanced malignant gastrointestinal tumors were injected with CART cells
15775317|NCT04652206|Drug|SCO-101|Oral tablets with a strength of 50 mg or 150 mg according to dose level (cohort). Administered for 6 consequtive days in a bi-weekly schedule in each treatment cycle. Treatment until disease progression.
15775318|NCT04652206|Drug|Gemcitabine|Used according to marketing authorisation
15775319|NCT04652206|Drug|Nab paclitaxel|Used according to marketing authorisation
15775320|NCT04652193|Procedure|Recovery profile from general anesthesia|It includes the phases during recovery from general anesthesia: Time to spontaneous ventilation, Laryngeal Mask Airway (LMA) removal time, open eyes, and Post-Anesthesia Care Unit (PACU) discharge.
15775321|NCT04652180|Procedure|Esophagectomy|In this monocentre randomized controlled trial, we compare robot-assisted thoracic approach with conventional open transthoracic Ivor Lewis esophagectomy.
15775322|NCT04652167|Diagnostic Test|PCT|"Serum PCT concentration is quantified with an automated sandwich immunoassay ECLIA (Elecsys®, BRAHMS PCT-analyses) on Cobas e801. Calibration (BRAHMS PCT LIA assay) is performed once per reagent lot and no later than 24 h after Cobas e pack has been registered in the instrument. Quality control is performed after each calibration."
15775323|NCT04652167|Diagnostic Test|suPAR|Serum suPAR was measured using suPARnostic© Turbilatex assay reagents (validated on Cobas© c111) protocol for Cobas© c702 and c502 applying the Multi-Pack cassettes (Roche Diagnostics, Mannheim, Germany). Calibration is performed at least once a month or in connection to a new batch of TurbiLatex reagents, after calibration a quality control is performed.
15775325|NCT04652154|Other|Transitioning young patients' health care trajectories|New intervention where the patient with multi-referrals to specialist health service meet with a complementary professional team consisting of doctor, psychologist and physioterapist aiming clarify the child's condition through shared decison-making and agreeing upon treatment plans for the child
15775326|NCT04652141|Diagnostic Test|AsthmaTuner|AsthmaTuner consists of a treatment-adjusting algorithm that gives patient immediate feedback on the status of symptom control (i.e. controlled, partly controlled or uncontrolled) and a treatment recommendation with an image of the correct inhaler or other type of medication and the dose based on lung function (FEV1) and symptom scores (0-4 points).
15775327|NCT04652128|Drug|Zoledronic acid|Subject will receive a single infusion of zoledronic acid 5mg/100mL intravenously.
15775328|NCT04652128|Drug|Placebo|Subject will receive a single infusion of physiological saline 100mL intravenously.
15775329|NCT04652115|Drug|Defibrotide|Deibrotide via IV
15775330|NCT04652102|Biological|CVnCoV|Intramuscular (IM) injection.
15775331|NCT04652102|Biological|Placebo|Intramuscular (IM) injection.
15775332|NCT04652089|Drug|Simvastatin 20mg|Simvastatin 20mg once a day for 7 days
15775333|NCT04652089|Drug|Placebo|Placebo once a day for 7 days
15775334|NCT04652076|Drug|NP137|Recombinant humanized IgG1 monoclonal antibody against Netrin 1. NP137 will be administred IV, Q3W until disease progression, unacceptable toxicity, death, patient or physician decision to withdraw, pregnancy or SMPC guidance, whichever occurs first.
15775335|NCT04652076|Drug|Pembrolizumab|Humanised monoclonal anti-programmed cell death-1 (PD-1) antibody will be administred in IV Q3W. A maximum 35 cycles of treatments (approximately 2 years) with pembrolizumab can be administered to patients.
15775336|NCT04652076|Drug|Paclitaxel|Standard Chemotherapy agent will be administred IV, Q3W, up to 6 cycles of treatment.
15775337|NCT04652076|Drug|Carboplatin|Standard Chemotherapy agent will be administred IV, Q3W, up to 6 cycles of treatment.
15775338|NCT04652063|Other|Osteopathic Manipulative Medicine|Osteopathic evaluation and treatment (gentle touch according to published protocols) will take about 15 - 20 minutes, and will be performed every 7 - 10 days during the infant's NICU stay once they reach at minimum of at least 28 weeks corrected gestational age and until they reach 36 weeks corrected gestational age.
15775339|NCT04652050|Drug|EMR Collection on use and outcomes of Tolsura|Patients fulfilling the inclusion criteria (see above) and placed on Tolsura for prophylaxis, and signed informed consent to participate in this study will be part of the study.
15775340|NCT04652037|Device|Acrysof IQ Vivity Toric Extended Vision Intraocular Lens Implantation|Implantation during bilateral cataract surgery of a new non-diffractive extended vision presbyopia and astigmatism correcting intraocular lens (Acrysof IQ Vivity Toric Extended Vision Intraocular Lens)
15775341|NCT04652024|Device|Anorectal manometry|, patients are instructed to isolate the anal sphincter and puborectalis muscles and improve its strength by using modified Kegel exercises in lying position with a probe in situ. Visual and verbal feedback techniques are used to reinforce the maneuvers, as they are being performed. The anal and rectal pressure changes displayed on the monitor provides visual feedback to the patient.
15775342|NCT04652011|Procedure|Minimally Invasive Gynecologic Surgery|Minimally Invasive Surgery for gynecologic disease (laparoscopy, robotic surgery, vaginal surgery)
15775343|NCT04652011|Procedure|osteopathic manipulative treatment|Osteopathic manipulative treatment
15775344|NCT04652011|Drug|Pain killer|Common pain killer (paracetamol, Ibuprofen, ketoprofen)
15775345|NCT04651998|Diagnostic Test|MMSE, MoCA, functional near-infrared spectroscopy|MMSE and MoCA are used for cognitive test before carotid artery stent implant and 6 months later. Cerebral blood oxygenation is evaluated by functional near-infrared spectroscopy under the mental task before and after revascularization within one week, 6 months later respectively.
15775346|NCT04651985|Other|Eccentric strengthening exercises of the Achilles tendon|This exercise will require the completion of slow active eccentric plantar flexion exercises with the forefoot positioned over the edge of a step. These exercises will be repeated twice daily (three sets of 15 repetitions with the knee in extension and three sets of 15 repetitions with the knee in flexion) during a three-month period. The amount of loading will be calibrated and progressed on a weekly basis by the physiotherapist according the participant's perceived effort and pain intensity.
15775347|NCT04651959|Drug|AVICOD 200 MG Film Tablet|AVICOD is containing 200 mg favipiravir manufactured by Pharma Plant,Turkey.
15775348|NCT04651959|Drug|AVIGAN 200 MG Film Tablets|AVIGAN is containing 200 mg favipiravir manufactured by Toyama, Japan
15775349|NCT04651946|Diagnostic Test|DNA methylation testing|Methylation testing of host DNA, namely, OPCML, FODX3 and CDH13, in the peripheral serum
15775350|NCT04651933|Genetic|Homologous recombination deficiency model|A homologous recombination deficiency (HRD) scoring model based on loss of heterozygosity (LOH)
15775351|NCT04651920|Genetic|Evaluation of homologous recombination deficiency score|Evaluation of homologous recombination deficiency score which is based on the loss of heterozygosity (LOH), telomere allele imbalance (TAI) and large-scale state transitions (LST)
15775352|NCT04651907|Other|acupuncture|use disposable sterile steel needles to insert to the acupuncture point
15775353|NCT04651907|Other|minimal acupuncture|The sham-controlled group will be performed with minimal acupuncture (superficial needling) at non-acupoints.
15775354|NCT04651894|Device|reactive hyperaemia index measurement|"reactive hyperaemia index with EndoPAT®
~Pulse wave velocity measurement with Sphygmocor®"
15775355|NCT04651881|Drug|Reference drug|1 Cap., single oral administration under fed condition
15775356|NCT04651881|Drug|Test drug 1|1 Tab., single oral administration under fed condition
15775357|NCT04651881|Drug|Test drug 2|1 Tab., single oral administration under fed condition
15775358|NCT04651868|Other|GLP-2|A 210 mins intravenous infusion with GLP-2 (10 pmol × kg^-1 × min^-1)
15775359|NCT04651868|Other|Placebo|A 210 mins intravenous infusion with isotonic NaCl
15775360|NCT04651868|Other|CCK|A 180 mins intravenous infusion with cholecystokinin (0.4 pmol × kg^-1 × min^-1)
15775361|NCT04651868|Other|Placebo|A 180 mins intravenous infusion with isotonic NaCl
15775362|NCT04651855|Drug|Mesenchymal stem cells isolated from Wharton's jelly|Intrathecal administration of mesenchymal stem cells
15775363|NCT04651842|Device|PCI|Acute Insulin Resistance on Myocardial Blush in Non- Diabetic Patients Undergoing Primary Percutaneous Coronary Intervention
15775364|NCT04651829|Other|oral food challenge 1|First oral food challenge after a short period of several weeks of avoidance of CMP to confirm diagnosis of CMPA
15775365|NCT04651829|Other|oral food challenge 2|Second oral food challenge to test tolerance after 4 months of age if confirmed CMPA
15775366|NCT04651816|Behavioral|Financial Incentives|Participants will be entered into a lottery to receive a gift card for class attendance.
15775367|NCT04651816|Behavioral|Motivational Message|Participants will be sent motivational messages through out their participation in the PSH DPP program.
15775368|NCT04651816|Behavioral|DPP Program|All Participants will be enrolled in the DPP program.
15775369|NCT04651790|Biological|SARS-CoV-2 inactivated vaccine|The vaccine contains inactivated SARS-CoV-2 virus, aluminum hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate and sodium chloride.The final product will be supplied in a pre-filled syringe containing 0.5 ml of solution for injection that corresponds to a dose of the vaccine.
15775370|NCT04651777|Drug|FF/UMEC/VI|The investigational drug is a single Ellipta inhaler containing 200 ug fluticasone furoate, 62.5 ug umedlidinium and 25 ug vilanterol. The drug is delivered in an Ellipta inhaler in a single dose once daily.
15775371|NCT04651764|Device|ColubrisMX Endoluminal Surgical (ELS) System|Robotically assisted transanal endoluminal resection of rectal lesion using the ColubrisMX Endoluminal Surgical (ELS) System
15775372|NCT04651751|Behavioral|Facilitating an Exercise Habit and Identity via the Multi-Process Action Control Model- A Randomized-Controlled Trial|Participants attended a workshop which consisted of a presentation and an exercise planning exercise.
15775373|NCT04651738|Diagnostic Test|DNA methylation testing|Methylation testing of host DNA, namely, BHLHE22, CELF4, HAND2, and ZNF177
15775374|NCT04651725|Other|Exercises|Patients were planned to complete exercise sessions 3 times a week for 12 weeks, each lasting 35 minutes per day.
15775375|NCT04651712|Diagnostic Test|POC-PCR|The result of the POC-PCR will be presented by the study assistant to the treating physician within four hours upon admission. The treating physician will along with the result receive a recommended action list, developed by microbiologists.
15775376|NCT04651699|Device|Active Transcranial Direct Current Stimulation|The Starstim tDCS® stimulator will be used by an experienced physical therapist to transfer direct current by a saline-soak pair of surface sponge electrodes (35cm2). The anode electrode will be placed over C3 (EEG 10/20 system) and the cathode electrode over the contralateral supraorbital area (Fp2), in order to enhance the excitability of M1 (32). Regarding the stimulated hemisphere, contralateral M1 will be stimulated in patients with asymmetric pain and the dominant (contrary to the dominant hand determined by the Edinburgh Handedness Inventory) in patients with symmetric pain, due to the widespread changes induced by tDCS in other cortical areas, including contralateral M1. A constant current of 2 milli amps intensity (subthreshold intensity) will be applied for 20 min, with 30 seconds of ramp-up and 30 seconds of ramp-down.
15775377|NCT04651699|Device|Sham Transcranial Direct Current Stimulation|The electrodes will be placed in the same positions as for M1 stimulation, but only applying ramping active current for 30 seconds in the beginning and at the end of the procedure for a reliable blinding.
15775378|NCT04651686|Other|Preoperative three-dimensional reconstruction and intraoperative protection of bronchial artery|All patients underwent chest enhanced CT examination with 64 slice spiral CT before operation. The bronchial artery was reconstructed by Mimics software. The bronchial artery was protected according to the preoperative three-dimensional reconstruction image during the lymph node dissection
15775379|NCT04651673|Other|This is a non interventional registry|All patients, at listed investigational sites, that get prescription for a knee orthosis indicated for Knee OA symptomatic treatment, get an invite to partake in the evaluation registry.
15775380|NCT04651660|Device|Neuro Cochlear Implant System|"Before the mastoidectomy, the ear canal is cleaned, the insert earphone is connected to the Eclipse (Oticon Medical software) preamplifier and placed into the ear canal. The EEG scalp electrodes (active, ground electrode) are placed on the patient's head. After the posterior tympanotomy, the reference electrode (eCochG probe) is placed on the cochlear promontory.
~The CI electrode array will be inserted following one of the two possible techniques while the eCochG will be recording. The surgeon will either manually insert the array using the Oticon Medical stylet and following the surgery guides and recommendations from Oticon Medical or will control the Robotol insertion angle and drive the robotic arm in the same way."
15775381|NCT04651647|Procedure|Revision surgery with / without open bone graft|Removal of previous implant and re-alignment and re-fixation using intramedullary nail with (bone graft group) / without (non bone graft group) open bone graft
15775382|NCT04651634|Drug|MIT-001 plus CCRT|MIT-001 IV-infusion plus CCRT
15775383|NCT04651621|Device|continuous theta burst stimulation over the SMA|Each cTBS session consists of bursts of three pulses delivered with a rate of 50 Hz, with bursts repeated at a rate of 5 Hz for a total duration of 40 seconds, summing up to 600 pulses, 100% of motor threshold (MT) and applied over bilateral SMA. The target is located in the anterior-posterior direction over the transition between pre-SMA and SMA proper, (cortical point where a vertical line will pass through the anterior commissure). The center of a figure-of-eight coil will be placed over the target, guided with neuronavigation equipment that utilizes the anatomical brain image from the pre-cTBS scanning session.
15775384|NCT04651621|Device|sham continuous theta burst stimulation over the SMA|The same stimulation parameters but a concealed sham coil will be used with only superficial magnetic stimulation to mimic the sensation of the active stimulation
15775385|NCT04651608|Behavioral|manuel acupressure|Acupressure was applied once by the researcher 30 minutes before applying the chemotherapeutic agent with medium or high emetogenicity to the randomized child. 3 fingers were placed on the child's wrist with their fingers and the region (point P6) between the flexor carpi radians and palmaris longus 1 cm below. Acupressure was applied to the wrist of the child by press for 2 minutes. The same procedure was applied to the other wrist. Then, data were recorded in accordance with the data collection procedure.
15775386|NCT04651608|Behavioral|sea-band acupressure|30 minutes before applying the chemotherapeutic agent with medium or high emetogenicity to the randomized child, sea-band acupress was applied by the researcher. The P6 point on the wrist was identified and marked with the child's own fingers. A sea band was attached to both wrists of the child by the researcher. The attached sea-band was allowed to remain for 15 minutes and was removed by the researcher at the end of the period. Separate sea-band was attached to each child. Acupress wrist bands, which are produced in separate sizes for adults and children, were used during the application, taking into account the physical development of the child, pediatric for the age range of 5-12, and adult size sea-band for the age of 12. Acupress application with sea-band was done once. Then, data were recorded in accordance with the data collection procedure
15775815|NCT04647851|Other|Remote exercise intervention Down syndrome|See arm description
15775387|NCT04651608|Behavioral|placebo manuel acupressure|Placebo manual acupress was applied in the next protocol for the child who was administered manual acupressure.
15775388|NCT04651608|Behavioral|placebo sea-band|Placebo sea-band was applied in the next protocol for the child who was administered sea-band acupressure.
15775389|NCT04651595|Procedure|Caudal block|caudal block with low dose bupivicaine 0.25% to preserve tone
15775390|NCT04651595|Drug|Morphine|morphine to control pain and avoid using muscle relaxant
15775391|NCT04651582|Behavioral|Cognitive Training|20 hours of computerized activities designed to improve processing speed and divided attention
15775392|NCT04651582|Behavioral|Cognitive Stimulating Activities|20 hours of traditional computer games
15775393|NCT04651569|Other|Observational study|none, Observational study
15775394|NCT04651556|Drug|Magnesium Sulfate & bupivacaine|intraperitoneal instillation of a combination of Magnesium sulphate with bupivacaine
15775395|NCT04651556|Drug|paracetamol & ketorolac|parenteral analgesics
15775396|NCT04651543|Other|X-Ray|X-ray obtained at one-week of the fracture
15775397|NCT04651530|Procedure|Phaco|phacoemulsification of cataract only
15775398|NCT04651530|Procedure|Phaco+ECP|Endoscopic cyclophotocoagulation is done in the same procedure as phacoemulsification of cataract
15775399|NCT04651517|Device|XACT ACE Robotics study arm|Subjects will undergo lung procedures with the physician utilizing the XACT ACE Robotic System.
15775400|NCT04651504|Other|Colorectal Cancer Toolkit|The intervention toolkit will include patient education materials and supportive materials for providers. Tracking systems and supports will be jointly developed with participating clinic and providers, in order to maximize their existing systems and develop processes that meet their needs and preferences, and training will be offered to help providers/teams efficiently use the tracking system and clinic resources. The study team will provide technical assistance and support through email, phone and zoom to support the clinic in their implementation process.
15775401|NCT04651491|Drug|Kagocel|"The researchers prescribed antiviral medications, including Kagocel, according to routine clinical practice. Patients who were assigned Kagocel were invited to participate in the study.
~Kagocel administration:
~for children from 3 to 6 years old (n=41): In the first 2 days - 1 tablet 2 times a day, in the next 2 days - 1 tablet once a day. Total for the course of administration 6 tablets within the period of 4 days.
~for children from 6 years old (n=39) - administered in the first 2 days - 1 tablet 3 times a day, in the next 2 days - 1 tablet 2 times a day. Total for the course of administration 10 tablets within the period of 4 days."
15775402|NCT04651478|Behavioral|Action Observation+Motor Imagery through BCI|Patients will undergo the treatment through the NeuRow platform. NeuRow is a gamified Brain-Computer Interface training paradigm in Virtual Reality (or neurogame) that allows patients to perform the same actions as they would do in real-life by imaging the movement. In NeuRow, patients will see a boat and two high fidelity virtual arms gripping two oars in the first-person view. Patients will have to imagine the movement of each corresponding hand to rotate each oar and progress, observing the movement imagined on screen. The goal of the task is to collect as many flags as possible in a fixed amount of time. In order to improve adherence, the number of flags collected will be recorded in each session. It will be able to adapt the boat speed, turn speed, and cut-off angle, to help patients not to deviate in excess from the target. The treatment itself will be performed for 20 minutes each session, divided into 4 series of 5 minutes to prevent fatigue.
15775403|NCT04651478|Behavioral|Action Observation through non-related with movement illustrations|The same configuration will be applied to simulate a BCI task, but playing a video about graphic illustrations, people's faces, and landscapes, never related to human movement. They will address interesting and changing topics to avoid patient's boredom. The control session will last 20 minutes, also divided into 4 series of 5 minutes and the therapist will give the instructions of observing and relax.
15775404|NCT04651465|Behavioral|Tuning in to Kids|A parenting program that includes 6 group supervisions of parents, where emotion coaching and promotion of kids emotional competence are main focus.
15775405|NCT04651452|Behavioral|Value Affirmation|Participants will complete writing tasks regarding their personal values.
15775406|NCT04651452|Behavioral|Reflective Journaling|Participants will complete writing tasks regarding their least important values and discuss why they may be important to others. They will also describe aspects of daily life.
15775407|NCT04651439|Drug|Filgrastim|"Injection of ZARZIO 30 MU/0,5mL and/or ZARZIO 48 MU/0,5mL, over a period of 5 consecutive days (1 injection per day during 30 minutes - - day 1 : set up standard treatment). The filgrastim solution will be diluted in 20 mL of 5% Glucose. The dose of ZARZIO administrated depends of the patient's weight :
~20 to < 30kg = 0,3 mL of ZARZIO 48 MU/0,5mL (subcutaneous route)
~30 to < 60kg = 0,5 mL of ZARZIO 30 MU/0,5mL (by IV)
~60 to < 90kg = 0,5 mL of ZARZIO 48 MU/0,5mL (by IV)
~90 to < 120kg = 2x0,5 mL of ZARZIO 30 MU/0,5mL (by IV)
~120 to 150kg = 0,5 mL of ZARZIO 30 MU/0,5mL + 0,5 mL of ZARZIO 48 MU/0,5mL (by IV)
~> 150kg = 2x0,5 mL of ZARZIO 48 MU/0,5mL (by IV)"
15775408|NCT04651439|Drug|Placebo|"Injection of 20 mL of Glucose 5% solution over a period of 5 consecutive days (1 injection per day during 30 minutes - day 1 : set up standard treatment). The dose given is equivalent to that used for filgrastim :
~20 to < 30kg = placebo not available because the injection must be done subcutaneously so the blind cannot be respected.
~30 to < 60kg = 20mL of Glucose 5% solution (by IV)
~60 to < 90kg = 20mL of Glucose 5% solution (by IV)
~90 to < 120kg = 20mL of Glucose 5% solution (by IV)
~120 to 150kg = 20mL of Glucose 5% solution (by IV)
~> 150kg = 20mL of Glucose 5% solution (by IV)"
15775409|NCT04651426|Device|The FIT Therapy patch (D. FENSTEC s.r.l. Altavilla Vicentina, Italy) is a medical device class 1|"The FIT Therapy patch (D. FENSTEC s.r.l. Altavilla Vicentina, Italy) is a medical device class 1 which mechanism of action is through the ability of biominerals to reflect the far infrared radiation (FIR). Normally the human body temperature would dissipate regular far infrared radiations but, thanks to the FIT Therapy (Far Infrared Technology), these waves are reflected and allowed to reach deeper areas in the human body (wavelength spectrum is 4-21 µm with a denser concentration around 11 µm).
~Every FIT device act as a mirror and they are able to induce an antalgic effect simply thanks to this biophysical process, therefore without releasing any active ingredient or creating a thermic shock.
~The plasters are made of 100% polypropylene non-woven fabric, an acrylic adhesive mass and a mix of titanium dioxide printed on. This particular mix in powder form is characterized by particles sizes above 100 nm."
15775410|NCT04651413|Diagnostic Test|PCR Value|Data collection and interpretation
15775411|NCT04651400|Drug|Antithrombin III|Antithrombin III
15775412|NCT04651387|Dietary Supplement|Ozonized oil (HOO|"In addition to the routine standard treatments for COVID-19, in the intervention group, combined use of HOO capsules and HOO oropharyngeal and nasal spray will be administered 3 times per day (after breakfast, lunch, dinner, possibly with a delay of one hour from the routine treatment) and will be prescribed for 2 weeks (14 days).
~Posology: 3 HOO capsules plus 3 HOO intranasal administrations for each naris plus 3 HOO oropharyngeal administrations."
15775413|NCT04651374|Device|geko T3|The device stimulates the peroneal nerve.It will be applied for the entire duration of ICU stay and replaced once every 24 hours.
15775414|NCT04651361|Drug|Dinalbuphine sebacate|Naldebain dissolved in benzyl benzoate and sesame oil (a total volume of 2ml) will be prepared in a 5-ml syringe 30 min before administration. Intramuscular injection into the gluteal muscles will be performed by an anesthesiologist under sonography-guidance.
15775415|NCT04651361|Drug|Placebo solution|Benzyl benzoate and sesame oil served as placebo solution (a total volume of 2ml) will be prepared in a 5-ml syringe 30 min before administration. Intramuscular injection into the gluteal muscles will be performed by an anesthesiologist under sonography-guidance.
15775416|NCT04651348|Drug|Recombinant Humanized Monoclonal Antibody MIL95|"PART A :The patients confirming to the eligibility criteria will be assigned to the 4 dose groups (0.1mg/kg, 0.3mg/kg, 0.8mg/kg, 1.0mg/kg, respectively) based on the sequence of inclusion. Each patient will receive an intravenous infusion of MIL95 every week on Day 1 for a maximum of Twelve weeks.
~PART B:One recommended dose as a priming dose will be selected from 4 dose groups(0.1mg/kg、0.3mg/kg、0.8mg/kg、1.0mg/kg) based on results of PART A. Each patient will receive a priming dose of MIL95 on Day 1 Cycle 1.The patients will be assigned to the 5 maintenance dose groups (3mg/kg, 10mg/kg, 20mg/kg, 30mg/kg, 45mg/kg, respectively) based on the sequence of inclusion. The maintenance dose was given on Day 8,15,22 Cycle 1 and on Day 1,8,15,22 Cycle 2+. Each cycle was 28 days."
15775417|NCT04651335|Device|afferent virtual reality program|When visual gaze training is applied to the left unilateral neglected patient, the gaze direction can be divided into an afferent direction closer to the body and an efferent direction away from the body. The concentric direction moves the ball from the left to the center of the body.
15775418|NCT04651335|Device|efferent virtual reality program|When visual gaze training is applied to the left unilateral neglected patient, the gaze direction can be divided into an afferent direction closer to the body and an efferent direction away from the body. The efferent direction moves from the center to the right.
15775419|NCT04651322|Device|upper robot Robot assisted upper arm training(RAT)|"The training group received an additional upper robot Robot assisted upper arm training(RAT) with Armeopower® 5 times per week for 4weeks.
~*Robot Assisted Arm training + Conventional occupational therapy"
15775420|NCT04651322|Behavioral|Conventional therapy|The control group received the usual conventional therapy *Only Conventional occupational therapy
15775421|NCT04651309|Other|Transperineal Ultrasound|The ultrasound examination will be conducted using the technique described by Hassan et al (2013). Briefly, transperineal ultrasound images are obtained by placing a covered transducer between the labia below the symphysis pubis. Small lateral movements of the probe are then made to align the ultrasound beam in a midsagittal orientation to include the whole cervical length after which the probe is rotated 90 degrees in order to measure the cervical dilatation. The probe is rotated up and down until the echogenic circle of the cervix is seen. Please note that this technique is widely used within the delivery room and that the ultrasound machine that will be used is frequently used within the delivery room.
15775422|NCT04651296|Behavioral|compassion meditation|manualized compassion meditation training
15775423|NCT04651296|Behavioral|health education|manualized health education group
15775424|NCT04651283|Other|Traditional seat group|"Each child in the control group was asked to conduct or follow instructions given for him or her to conduct the following hand function tasks for three successive months of treatment, three times per week (every other day):
~Building towers and shapes with different textures weights and bright colors.
~Inserting different shapes in the correct hole.
~Dropping pellets.
~Stringing beads.
~Copying square and triangle.
~Opening the bottle and close it.
~Folding and Crumpling paper.
~Cutting paper by scissors.
~Tracing line and connecting dots.
~Reaching above the level of shoulder.
~Reaching across the midline.
~Squeezing water out of a sponge.
~Buttoning and unbuttoning button.
~Playing clapping games.
~Turning pages in a book.
~Lacing string.
~Picking up a small piece of food and bringing it into the palm.
~Moving a penny from the palm to the fingers.
~Removing socks.
~Brush the teeth."
15775425|NCT04651283|Other|Adaptive seating equipment group|"Each child in the study group was asked to conduct or follow instructions given for him or her to conduct the following hand function tasks for three successive months of treatment, three times per week (every other day):
~Building towers and shapes with different textures weights and bright colors.
~Inserting different shapes in the correct hole.
~Dropping pellets.
~Stringing beads.
~Copying square and triangle.
~Opening the bottle and close it.
~Folding and Crumpling paper.
~Cutting paper by scissors.
~Tracing line and connecting dots.
~Reaching above the level of shoulder.
~Reaching across the midline.
~Squeezing water out of a sponge.
~Buttoning and unbuttoning button.
~Playing clapping games.
~Turning pages in a book.
~Lacing string.
~Picking up a small piece of food and bringing it into the palm.
~Moving a penny from the palm to the fingers.
~Removing socks.
~Brush the teeth."
15775426|NCT04651270|Device|SurroundScope|The study will evaluate standard laparoscopic surgery using the 270Surgical system. The procedure will be performed according to the institution's standard of care, using the SurroundScope for visualization.
15775427|NCT04651257|Device|Contrast mammography (CEM)|Contrast mammography in pathological nipple discharge
15775428|NCT04651244|Diagnostic Test|MRI|Gold standard for identifying inflammatory changes in patients with acute pyelonephritis
15775429|NCT04651244|Diagnostic Test|Ultrasound performed by a radiologist|US performed by a radiologist including standard grayscale evaluation of the kidneys, Doppler US and contrast enhanced US (CEUS).
15775430|NCT04651244|Diagnostic Test|Point of care ultrasound|Point of care US by a study assistant with basic ultrasound skills and training to access the presence or absence of hydronephrosis. If hydronephrosis is present it will be graded into one of four categories.
15775431|NCT04651231|Procedure|releasable sutures in punch trabeculectomy|punch trabeculectomy,scleral flap suturing
15775432|NCT04651218|Behavioral|exericse|participants perform aerobic exercise until they expend 500 kcal
15775433|NCT04651205|Dietary Supplement|vitamin B1 and magnesium supplements|vitamin B1 - 100 mg/day magnesium - 400 mg/day
15775434|NCT04651192|Other|Combat Exposure|Soldiers will be exposed to combat as part of their routine military service. The ROTC students will not be exposed to combat.
15775435|NCT04651179|Other|observation|not applicable, observational study
15775436|NCT04651166|Drug|Tranexamic acid|1g tranexamic acid mixed in 100mL saline or lactated ringer
15775437|NCT04651166|Drug|Placebo|100mL saline or lactated ringers
15775438|NCT04651153|Drug|UCB7853|Subjects will receive UCB7853 at pre-specified time-points.
15775439|NCT04651153|Other|Placebo|Subjects will receive Placebo at pre-specified time-points.
15775440|NCT04651140|Behavioral|aerobic exercise|Participants ride an Acon-8650 model exercise bicycle 3 times a week for 1 hour each time for four consecutive weeks
15775441|NCT04651127|Drug|Toripalimab + Chidamide|In combination dose finding phase, phase 1b will begin with Dose Level 1: chidamide 30 mg/day orally (twice a week) and toripalimab (240mg q3w, intravenously) will be administered to eligible subjects on a 21-day treatment cycle. Two dose de-escalation steps are included: Dose Level 2 (chidamide 25 mg/day orally, twice a week and toripalimab 240mg q3w, intravenously) and Dose Level 3 (chidamide 20 mg/day orally, twice a week and toripalimab 240mg q3w, intravenously). If RP2D was reached in Part A, eligible patients would be enrolled and receive toripalimab (240mg q3w, intravenously) plus chidamide (RP2D, twice a week).
15775442|NCT04651114|Behavioral|Decision-making tool|"Women will be directed to a secure website to download a copy of the decision making tool and worksheets (they can download as many copies as they wish to). The women will use the tool and worksheets at their own pace for the pilot study period.
~The decision making tool is a 23-page tool and set of 9 downloadable worksheets. The tool covers topics relevant to women with disabilities in considering or planning a pregnancy: 1) Overview of Pregnancy: 2) Knowing what is important; 3) Partners, family and important relationships; 4) Physical function and independence; 5) Health and wellbeing; 6) Caring for an infant; 7) Financial resources & insurance; 8) How to find reliable information and resources; 9) Connecting with other women with physical disabilities; 10) Dealing with reactions of others, stigma and bias, pressure; and 11) Reaching a decision."
15775443|NCT04651101|Diagnostic Test|coronary angiography|extent of coronary artery disease in invasive coronary angiography
15775444|NCT04651088|Drug|Potassium citrate|Slow release potassium citrate UroCit-K. Participants will take 20mEq twice daily.
15775445|NCT04651088|Drug|Sodium bicarbonate|650mg tabs. Take 3 tabs twice daily.
15775446|NCT04651088|Dietary Supplement|Litholyte|One packet is taken with 170ml of water. Two packets daily.
15775447|NCT04651088|Dietary Supplement|Crystal Lite|The classic lemonade contains 21.7mEq/liter of alkali Therefore, patients will take 2 litres daily to have the 40mEq of alkali daily needed.
15775448|NCT04651075|Other|music listening|The music selected by the participants was played to the music listening group.
15775449|NCT04651075|Other|individual training|Individual training group was trained on coronary angiography.
15775450|NCT04651062|Device|endocuff|Endocuff is a relatively new device which is intended to be attached to the end of the colonoscope.
15775451|NCT04651062|Procedure|no endocuff|colonoscopy is performed without endocuff.
15775452|NCT04651049|Drug|propranolol|This retrospective study included 128 patients treated with oral propranolol at a dose of 2.0 mg/kg per day.
15775453|NCT04651036|Drug|QL0605|a pegfilgrastim biosimilar to US Neulasta.
15775454|NCT04651036|Drug|US Neulasta|US Neulasta
15775455|NCT04651023|Dietary Supplement|Nelumbo nucifera Leaf Extract|Hot water extracted Nelumbo nucifera Leaf, mainly containing quercetin and quercetin 3-O-glucuronide.
15775456|NCT04651010|Other|Multimodal MRI|Multimodal MRI will be realized between 12 and 24 hours after thrombectomy
15775457|NCT04650997|Behavioral|Eccentric exercise|Knee eccentric exercise with sham or focused extrocorporeal shockwave therapy for 12 weeks
15775458|NCT04650984|Drug|Onfekafusp alfa|Patients will receive a fixed dose of L19TNF in combination with a fixed dose of doxorubicin.
15775459|NCT04650984|Drug|Doxorubicin|Patients will receive a fixed dose doxorubicin, administered as a 15 ± 5 minutes i.v. infusion.
15775460|NCT04650971|Biological|UniFluVec|Vaccination was performed intranasally (0.25 ml in each nostril) twice with an interval of 3 weeks
15775461|NCT04650971|Biological|Placebo|Vaccination was performed intranasally (0.25 ml in each nostril) twice with an interval of 3 weeks
15775462|NCT04650958|Procedure|Deep brain stimulation|Deep brain stimulation (DBS) has been in use to treat patients with movement disorders since 1989, with many thousands of publications showing its effectiveness. DBS for dystonia received the US FDA mark in 2003 and China FDA mark in 2016. In this study, the DBS system devices are manufactured and donated by SceneRay (Suzhou, China). The Stimulator System is implanted by a qualified neurosurgeon and consists of three implantable components: the leads, the extension wires and the neurostimulator. The DBS programming will start within 1 week after the surgery completed.
15775464|NCT04650932|Device|Deep brain stimulation|Patients with idiopathic Parkinson's disease who have previously been implanted with the Boston Scientific VerciseTM DBS system for at least 3 months. These patients will already be receiving high-frequency dorsal STN stimulation as part of the standard of care for PD. Once patients have provided consent and are enrolled in this study, they will receive simultaneous low-frequency stimulation of the ventral STN to examine if there are any effects on cognitive performance.
15775465|NCT04650919|Procedure|Total laryngectomy and reconstruction by stented aortic allograft (using human tissue and device).|"The procedure consists of 2 operating times:
~Surgery S1 (1st surgical procedure): total laryngectomy and placement of the stented aortic graft (human tissue + device: NOVATECH GSS TM (trademark) TD), under tracheotomy cover.
~Surgery S2 (2nd surgical procedure) (between S1 +24 weeks and S1 +36 weeks) : opening of the proximal part of the graft by endoscopic way with maintenance of the tracheotomy orifice to ensure patient safety."
15775494|NCT04650659|Diagnostic Test|6-minute walk test part one|Measurement of: 6-minute walk distance, the modified Borg scale before and after testing and continuous measure of peripheral oxygen saturation and heart rate. The peripheral oxygen saturation will be measured continuously on three anatomical location: the forehead, an earlobe and a finger. In patients who will accept an arterial line will be placed and blood gas will be analyzed.
15775532|NCT04650347|Procedure|visualized internal urethrotomy|incision of a urethral stricture to treat urinary obstruction using Quanta Holmium device or Sache cold knife, 18 Fr silicon catheter was kept for 7 days following the prodecure.
15775466|NCT04650906|Behavioral|Mindhelper - a national youth mental health promotion website|Mindhelper is a fully digital youth mental health service reaching out to a large number of young people when and where they need it, with full anonymity. Mindhelper was developed in 2014-2017 by Centre for Telepsychiatry in the Region of Southern Denmark in a partnership with four Danish municipalities. The development of the site was funded by the Danish foundation TrygFonden. The original idea behind the site was inspired by the Australian youth mental health promotion service ReachOut.com. The Mindhelper service was launched in September 2016. From January 2019 Mindhelper received permanent funding through a joint agreement between the five Danish Regions. Mindhelper is Denmark's most comprehensive youth mental health promotion website where young people can seek mental health information, advice, and self-help tools to improve their mental health and well-being. Since it was launched, the site has been very successful in attracting large numbers of visitors.
15775467|NCT04650893|Drug|Intravenous Ketorolac|To assess the efficacy of the meds for dysphagia and dysphonia following ACDF
15775468|NCT04650893|Drug|Intravenous Dexamethasone|To assess the efficacy of the meds for dysphagia and dysphonia following ACDF
15775469|NCT04650893|Drug|Placebo|Control
15775470|NCT04650880|Dietary Supplement|Vitamin D|Vitamin D supplementation
15775471|NCT04650880|Other|Placebo|Placebo tablets with the same external appearance
15775472|NCT04650867|Device|Multispectral Optoacoustic Tomography (MSOT)|Non-invasive transcutaneous MSOT imaging of the bowel wall (terminal ileum, ascending caecum/colon, transverse colon, descending colon, and sigmoid colon).
15775474|NCT04650841|Drug|Placebo Cream with Naloxone|Participants will be informed that the spray is an effective pain and negative emotion reducing agent.
15775475|NCT04650841|Drug|Control Cream with Naloxone|Participants will be informed that the spray is saline.
15775476|NCT04650841|Drug|Placebo Cream with Saline|Participants will be informed that the spray is an effective pain and negative emotion reducing agent.
15775477|NCT04650841|Drug|Control Cream with Saline|Participants will be informed that the spray is saline.
15775478|NCT04650828|Drug|TDF|TDF combined with telbivudine (LDT) for 12 months
15775479|NCT04650828|Drug|Tenofovir Disoproxil Fumarate 300 MG|TDF monotherapy was continued for 12 months
15775480|NCT04650802|Device|Gait training|Participants receive five weeks individual robotic gait training in LOPES II, targeting paretic propulsion (60 minutes, two time a week). The robotic gait training is complemented with daily home exercises (15 minutes/day) focusing on increasing strength and practice of learned strategies in daily life.
15775481|NCT04650776|Other|Heat strain|The experimental procedure comprised 15 min baseline seated rest (23.2 ± 0.3°C, 24.5 ± 1.6% relative humidity), followed by 15 min seated rest and cycling in a climatic chamber (35.4 ± 0.2◦C, 56.5 ± 3.9% relative humidity; to +1.5◦C or maximally 38.5°C rectal temperature, duration 20-60 min), with a final 30 min seated rest outside the chamber.
15775482|NCT04650763|Biological|PRP injection|PRP was prepared using patient's blood and mixed with saline or mixture of calcium chloride and thrombin to form a liquid solution; in order to inject at the surgical site after placement of implant.
15775483|NCT04650763|Device|Automated blood cell separator to extract PRP|Blood was withdrawn from antecubital vein and mixed with anticoagulant. Blood sample was then centrifuged to obtain platelet rich plasma which was injected at surgical site after implant placement.
15775484|NCT04650750|Drug|Xiao-Feng-San+Shian-Fang-Hwa-Ming-Yiin|"Xiao-Feng-San is a common Chinese herbal preparation, composed of 13 herbs, which is used to treat patients with dermatitis. The component of Xiao-Feng-San has immunomodulatory activity. Shian Fang Hwa Ming Yiin is another common Chinese herbal preparation, composed of 12 herbs, which is used to treat patients with carbuncles and acne. The component of Shian Fang Hwa Ming Yiin has anti-inflammation and anti-microbial effect."
15775485|NCT04650750|Drug|Placebo|Similar placebo 4g twice a day for two months
15775486|NCT04650737|Drug|single shot ESBP with dexmedtomidine|Patients in this group will receive errector spine plane block with 30 ml bupivacaine 0.25% plus 1ml of 1µg/kg Dexmedetomidine
15775487|NCT04650737|Drug|continous ESPB|Patients in this group will receive erector spine plane block with 30 ml bupivacaine 0.25%plus 1ml normal salinefollowed by continuous infusion of 8ml / hour of 0.125% bupivacaine for 24 hrs.
15775488|NCT04650724|Drug|T cell infusion agent targeting BCMA chimeric antigen receptor|Chimeric antigen receptor T cells (car-t) is one of the most effective therapies for malignant tumors (especially hematological tumors). Like other immunotherapies, the basic principle is to use the patient's own immune cells to clear cancer cells. Chimeric antigen receptor (car) is the core component of car-t, which endows T cells with the ability to recognize tumor antigens in an independent manner, which enables car modified T cells to recognize a wider range of targets than natural T cell surface receptors (TCR). The basic design of car includes a tumor associated antigen binding region (usually derived from scFv segment of monoclonal antibody antigen binding region), transmembrane region and intracellular signal region. The selection of target antigen is a key determinant for the specificity and effectiveness of car and the safety of genetically modified T cells.
15775489|NCT04650711|Diagnostic Test|p16 protein expression|P16INK4A immunohistochemical staining is to be performed in residual cytology samples.
15775490|NCT04650698|Drug|Tranexamic acid|IV, Total Dosage: 2 grams (1 gram before surgical incision + 1 gram, 3 hours after first dose)
15775491|NCT04650685|Device|The novel Salvadora persica toothbrush|The novel Salvadora persica toothbrush will be used twice daily without the application of toothpaste. Modified bass technique will be applied. A demonstration by another investigator will be done via video, written instructions and a tell-show-do method using typodont model.
15775492|NCT04650685|Device|The Salvadora persica (miswak) chewing stick|The Salvadora persica chewing stick will be used twice daily without the application of toothpaste. The Salvadora persica chewing sticks need to be prepared prior to use. A five-finger grip technique will be applied. A demonstration by another investigator will be done via video, written instructions and a tell-show-do method using typodont model.
15775493|NCT04650685|Device|Standard toothbrush and toothpaste (control)|The novel Salvadora persica toothbrush will be used twice daily without the application of toothpaste. Modified bass technique will be applied. A demonstration by another investigator will be done via video, written instructions and a tell-show-do method using typodont model.
15775816|NCT04647838|Drug|Tepotinib|Tepotinib 500mg (2 tablets of 250mg) per day D1-21 orally, once daily
15775495|NCT04650659|Diagnostic Test|6-minute walk test part two|Measurement of: 6-minute walk distance, the modified Borg scale before and after testing and continuous measure of peripheral oxygen saturation and heart rate. The peripheral oxygen saturation will be measured continuously on three anatomical location: the forehead, an earlobe and a finger. No arterial line will be placed.
15775496|NCT04650659|Diagnostic Test|1-minute sit-to-stand test|Measurement of: Number of repetitions, the modified Borg scale before and after testing and continuous measure of peripheral oxygen saturation and heart rate. The peripheral oxygen saturation will be measured on the three anatomical locations mentioned above.
15775497|NCT04650659|Diagnostic Test|4-meters gait speed test|Measurement of: Time to complete the 4 meters course and calculation of the 4-meters-gait-speed.
15775498|NCT04650659|Diagnostic Test|Nailfold videocapillaroscopy|"Capillary density measurement of: The finger with the probe and the average of all the fingers.
~NVC with 200 x magnification will be performed on the 2nd to 5th finger on both hands."
15775499|NCT04650646|Other|Exercise-related hypoglycaemia|Hypoglycaemia induced by intravenous insulin and exercise on a vertical cycle ergometer.
15775500|NCT04650646|Other|Hypoglycaemia under resting conditions|Hypoglycaemia induced by intravenous insulin during bed rest.
15775502|NCT04650620|Device|Plenhyage® thin|0.75%
15775503|NCT04650620|Device|Plenhyage® medium|2%
15775504|NCT04650620|Device|Plenhyage® strong|2.5%
15775505|NCT04650607|Other|Adverse event after injection of phages|rate and description of adverse event after injection of phages
15775506|NCT04650594|Procedure|MUTARS® modular reconstruction prostheses|Patients with MUTARS® modular reconstruction prostheses following primary or secondary knee bone malignancy with minimal follow-up of one year
15775507|NCT04650581|Drug|Ipatasertib|400 mg PO QD days 1-21 every 28 days
15775508|NCT04650581|Drug|Fulvestrant|500 mg IM cycle 1 days 1 and 15 followed by 500 mg IM day 1 q 28 days subsequent cycles
15775509|NCT04650581|Other|Placebo|PO QD days 1-21 every 28 days
15775510|NCT04650568|Device|Autologous Bone Marrow Derived Mesenchymal Stem Cells|Autologous Bone Marrow Derived Mesenchymal Stem Cells injected into the ACL allograft prior to graft implantation.
15775511|NCT04650568|Other|Sham incision|Small incision over the site where bone marrow aspirate would have been obtained
15775512|NCT04650555|Drug|BIO 300 Oral Powder|Amorphous solid dispersion of genistein milled into a powder
15775513|NCT04650542|Drug|HBI-3000|small molecule, multi-ion channel blocker
15775514|NCT04650542|Drug|Paroxetine|serotonin uptake inhibitor, CYP2D6 inhibitor
15775515|NCT04650529|Device|stent, ballooning|DES, BMS, BRS, DEB, and POBA can be used for PCI
15775516|NCT04650516|Device|Virtual reality|20 minutes treatment in virtual reality
15775517|NCT04650516|Device|Digital control|20 minutes digital control movie on tablet without virtual reality
15775518|NCT04650503|Other|No intervention|No intervention
15775519|NCT04650490|Radiation|Stereotactic Radiosurgery|Timing of stereotactic radiosurgery relative to immunotherapy
15775520|NCT04650490|Drug|Immunotherapy|Physician's choice of immunotherapy per standard of care
15775521|NCT04650477|Procedure|Fixation while forearm in extension-pronation position|Fixation was performed after tenodesis in the extension-pronation position, which is the anatomically most suitable position of the biceps tendon.
15775522|NCT04650451|Biological|chimeric antigen receptor (CAR) T cell therapy|HER2-targeted dual-switch CAR-T cells
15775523|NCT04650438|Device|Transcranial Magnetic Stimulation (TMS) over the left inferior frontal gyrus (IFG)|MagPro X100, with MagPro software version 7.1; connected to a figure-of-eight coil (MC-B70) or a circular coil (MC-125). The device is CE marked and bears an ISO 13485 certificate complying with good manufacturing practice. Continuous theta burst stimulation protocol will be applied.
15775524|NCT04650438|Device|Transcranial Magnetic Stimulation (TMS) over the left inferior parietal lobule (IPL)|MagPro X100, with MagPro software version 7.1; connected to a figure-of-eight coil (MC-B70) or a circular coil (MC-125). The device is CE marked and bears an ISO 13485 certificate complying with good manufacturing practice. Continuous theta burst stimulation protocol will be applied.
15775525|NCT04650425|Behavioral|Cognitive tasks|Patients will perform the coffee-tea task and the virtual T-maze task, both in the acute and chronic phase after stroke.
15775526|NCT04650412|Other|Bundle of comorbidities care|Pulmonary function tests, blood gas analysis, transthoracic echocardiography, sleep study after stabilization of patient's index clinical condition, thus 1 month after hospital discharge
15775527|NCT04650399|Biological|Live-attenuated CHIKV|Live-attenuated CHIKV in a lyophilized formulation (1x10E4 TCID50 per 0.5 mL)
15775528|NCT04650399|Biological|Placebo|Phosphate buffered saline, PBS
15775529|NCT04650386|Behavioral|Psychosocial support determined by adaptive treatment algorithm|Participants assigned to the adaptive intervention condition will be scheduled for buprenorphine medication management appointments according to the clinic protocol described above for TAU. The adjunctive psychosocial treatment that participants in this condition receive are (1) CBT delivered by behavioral health specialists and/or (2) peer support delivered by certified recovery specialist. The active intervention period will span 3 months post-study entry. Participants will continue to receive TAU following the active intervention period.
15775530|NCT04650373|Procedure|Bariateric surgery|Adult patients underwent RYGB surgical treatment during the period from 2014 to 2019
15775531|NCT04650360|Behavioral|Postoperative Intervention Educational Program|The health educational program consisted of a single training session offered by a nursing professional to each patient and caregiver. In each educational session, the following topics were addressed: objectives for functional recovery (early mobilization, recovery of functional capacity lost prior to the fracture, etc.), mobilization exercises to start the day after the surgical procedure (lower limb exercise, respiratory physiotherapy, etc.), and tips to prevent future falls. The educational session was implemented during the postoperative hospital stay, with an approximate duration of 30-45 min. The session ended with a summary of the content and comments from the patient and relative in order to ensure understanding of the program. Written information was provided on the aspects addressed in the session (brochures). These patients were treated according to routine protocols. All patients were monitored during admission, at 1 month, at 6 months, and at 1 year after the intervention
15775533|NCT04650334|Behavioral|Collaborative Care|Health services intervention to implement a team based model of care for perinatal depression.
15775534|NCT04650321|Drug|Ocrelizumab at home|Patients will receive ocrelizumab infusion at home.
15775535|NCT04650308|Diagnostic Test|Neuropeptide Y examination|This examination was conducted by drawing blood serum from research subjects and performing centrifugation with 2000-3000 revolutions per minute (RPM) for 20 minutes. Furthermore, we carried out blood serum tests to check neuropeptide Y levels using the Human Neuropeptide Y Enzyme-link Immunosorbent Assay (ELISA) kit
15775536|NCT04650295|Other|Household Remedy|If the participant experiences a muscle cramp one tablespoon (one sip) of the household product will be taken. The treatment phase of the study will be for 28 days.
15775537|NCT04650295|Other|Tap water|If the participant experiences a muscle cramp one tablespoon (one sip) of tap water will be taken. The treatment phase of the study will be for 28 days.
15775538|NCT04650282|Combination Product|Lidocaine in SphenoCath device|Participants will receive 2.5 cc of lidocaine 1% solution intranasally via a SphenoCath device into each nares.The portion of the procedure involving this device lasts approximately 30-60 seconds.
15775539|NCT04650282|Combination Product|Saline Solution in SphenoCath device|Participants will receive saline solution via a SphenoCath device into each nares. The portion of the procedure involving this device lasts approximately 30-60 seconds.
15775540|NCT04650269|Drug|Biktarvy 50Mg-200Mg-25Mg Tablet|Daily Biktarvy (50/200/25mg) combination ART by mouth for 6 months
15775541|NCT04650269|Other|HIV care|HIV primary care (including Biktarvy delivery) will be conducted outside of a clinical setting by a community-based harm reduction program for 6 months.
15775542|NCT04650256|Other|Complementary and alternative medicine (CAM)|CAM will be applied topically on the chest wall once during the day (or immediately after radiotherapy) and once at night daily.
15775543|NCT04650243|Drug|ursodeoxycholic acid|The two experimental groups will receive reduced dosage of UDCA at 250mg bid and 250mg qd respectively, while the control group will receive standard dosage of UDCA.The treatment duration will be five years.
15775544|NCT04650230|Device|nasal continuous positive airway pressure / nasal positive pressure ventilation (NCPAP/NPPV) and high flow nasal cannula (HFNC) devices|
15775545|NCT04650217|Drug|Carbidopa/levodopa|"L-DOPA is the immediate precursor of dopamine, is converted to dopamine in presynaptic dopaminergic nerve terminals, and enhances dopaminergic transmission in multiple brain regions. Subjects assigned to L-DOPA will begin with a Week 1 L-DOPA daily dosage of 150mg, or 1.5 25mg carbidopa/100mg levodopa tablets at 9am and placebo tablets at
~1pm and 5pm. In Week 2 the L-DOPA daily dose will increase to 300mg (1.5 25mg carbidopa/100mg levodopa tablets at 9am and 5pm, with placebo at 1pm), followed by a Week 3 to 8 L-DOPA daily dose of 450mg (1.5 25mg carbidopa/100mg levodopa tablets three times daily). Subjects assigned to placebo will take 1.5 placebo tablets three times daily for three weeks. Individuals will be instructed to maintain the same timing of doses throughout the study. Individuals unable to tolerate an increased dose will have their dosage reduced to the maximum previously tolerated dose."
15775546|NCT04650217|Drug|Placebo|Carbidopa/levodopa matched placebo
15775547|NCT04650217|Behavioral|Exercise training|Subjects assigned t Exercise will exercise individually at their home on a program set each week by Dr. Sloan and the research assistant (RA) coach, who will work with the patient to ensure they train according to the program at the appropriate level of intensity. Subjects will select from a series of aerobic activities and for Weeks 1-2 will train at 55-65 percent of maximum HR as established during their qualifying CPET. In Weeks 3-4, they will increase exercise intensity to 65-75 percent of maximum HR, and in Weeks 5-12 they will train at 75 percent of maximum HR.
15775548|NCT04650217|Behavioral|Control|Control will engage in a series of stretches and toning exercises designed to promote flexibility and improve core strength.
15775549|NCT04650204|Drug|Phenobarbital, Phenytoin, Carbamazepine, Valproate, Gabapentin, Pregabalin, Lamotrigine, Topiramate, Leviteracetam, Lacosamide, Zonisamide, Clobazam, Oxcarbezepine, Rufinamide|Given ASD
15775550|NCT04650204|Drug|Perampanel|Given PO
15775551|NCT04650204|Other|Quality-of-Life Assessment|Ancillary studies
15775552|NCT04650204|Other|Questionnaire Administration|Ancillary studies
15775553|NCT04650191|Other|Identification of genetic variants|DNA will be extracted from whole blood from study subjects
15775554|NCT04650178|Other|Quality-of-Life Assessment|Ancillary studies
15775555|NCT04650178|Other|Questionnaire Administration|Complete questionnaire
15775556|NCT04650152|Drug|Tricor (fenofibrate), 145 mg, film-coated tablet|Observational study without intervention. Fenofibrate is prescribed in routine manner in accordance with clinical practice and the valid Instruction for Medical Use regarding the dose, duration of therapy, patient population, and therapeutic indication.
15775557|NCT04650139|Procedure|PCI - percutaneous coronary intervention|percutaneous coronary intervention
15775558|NCT04650126|Biological|ATM001|monovalent anti-TNF-receptor 1 antibody format
15775559|NCT04650126|Biological|ATM001 Placebo|ATM001 Placebo
15775560|NCT04650113|Combination Product|MTA material|Partial pulpotomy is a procedure in which the inflamed tissue beneath an exposure is removed to a depth of 1 to 3 mm or deeper to reach healthy pulp tissue.
15775561|NCT04650100|Procedure|ultrasound-guided PENG bloc realized before surgery|ultrasound-guided PENG block realized before surgery. The PENG block, described by Giron-Arebgi is made in the supine position. The ultrasound probe used is a 5 MHz high frequency linear probe placed parallel to the line delimited by the anterior-inferior iliac spine (lateral) and the pubis (medial). The needle used is an 80 mm, 22G, needle inserted in the ultrasound plane. The slow and fractioned injection of 20 ml of Ropivacaine 4.75 mg/ml is performed in the fascia between the psoas tendon and the iliopubic eminence under ultrasound guidance.
15775562|NCT04650087|Drug|Apixaban 2.5 MG|Participants will take Apixaban 2.5 MG twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
15775585|NCT04649879|Other|Standard of care|Standard of care as determined by hospital practices for COVID-19 patients.
15775617|NCT04649528|Behavioral|Effective endurance 4x4 training - Supervised|Exercise intervention utilizing 4x4min aerobic high-intensity interval training
15775563|NCT04650087|Drug|Placebo|Participants will take placebo twice a day, once in the morning and once in the evening for 30 days. Participants will be contacted (electronic or telephone) 2 days after starting the study medication and will continue up to day 90 after starting study treatment. Followup will occur from the time of discharge through the 30 day study period with contacts at 2 days, 10 days, 20 days and 30 days after discharge. Two additional study contacts will take place 45 days and 90 days after discharge.
15775564|NCT04650074|Drug|LIDOCAINE 20 mg|"4 injections (on day 1, day 7, day 14, day 30) by mesotherapy of 20 mg Lidocaine (qsp 6 ml NaCl 0.9%).
~Each mesotherapy session includes 2 steps performed chronologically. It will be done within 2 or 3 minutes each one:
~1st sequence: intra-epidermal injections of 3 ml by manual technique in crossed lines with a 13 mm x 0.30 needle,
~2nd sequence : superficial intradermal injections of 3 ml (between 1 and 2 mm) using a technique assisted by a Pistor Eliance injector at a frequency of 200 punctures per minute."
15775565|NCT04650074|Drug|LIDOCAINE 20 mg + KETAMINE 20 mg|"4 injections (on day 1, day 7, day 14, day 30) by mesotherapy of 20 mg Lidocaine + 20 mg Ketamine (qsp 6 ml NaCl 0.9%).
~Each mesotherapy session includes 2 steps performed chronologically. It will be done within 2 or 3 minutes each one:
~1st sequence: intra-epidermal injections of 3 ml by manual technique in crossed lines with a 13 mm x 0.30 needle,
~2nd sequence : superficial intradermal injections of 3 ml (between 1 and 2 mm) using a technique assisted by a Pistor Eliance injector at a frequency of 200 punctures per minute."
15775566|NCT04650074|Drug|LIDOCAINE 20 mg + KETAMINE 40 mg|"4 injections (on day 1, day 7, day 14, day 30) by mesotherapy of 20 mg Lidocaine + 40 mg Ketamine (qsp 6 ml NaCl 0.9%).
~Each mesotherapy session includes 2 steps performed chronologically. It will be done within 2 or 3 minutes each one:
~1st sequence: intra-epidermal injections of 3 ml by manual technique in crossed lines with a 13 mm x 0.30 needle,
~2nd sequence : superficial intradermal injections of 3 ml (between 1 and 2 mm) using a technique assisted by a Pistor Eliance injector at a frequency of 200 punctures per minute"
15775567|NCT04650061|Behavioral|Motivational Interview (MI) & Adherence Follow-Up|With MI, the key goal is to empower the patient to commit to follow CPAP therapy, while providing empathic support, in a positive atmosphere, and without prejudice. The nurse does not directly advocate for behavior change (i.e. use CPAP as prescribed), but asks key questions to help the patient explore their feelings about the change, weighs the pros and cons of such change, and allows the patient to realize the discrepancy between the current risk (that is, not using CPAP as directed) and the benefits with good adherence.
15775568|NCT04650061|Device|Adherence Follow-Up|The nurse takes the compliance of the CPAP device, and ask to the patient if he had some problems.
15775569|NCT04650048|Device|Active HD-tDCS|Using the Starstim 32, HD-tDCS equipment we provide 20 minutes of 2 mA anodal multimodal stimulation of dorsolateral prefrontal cortex (DLPFC) and primary motor cortex simultaneously using ring-cathode configurations around the two anodes.
15775570|NCT04650048|Device|Sham HD-tDCS|"Using the Starstim 32, HD-tDCS equipment we provide sham stimulation with 30 seconds of ramping up to 2 mA intensity, then turning off for 19 minutes and then ramping down from 2 mA intensity to 0 in the last 30 seconds.
~This sham-configuration is intended to mimic the sensory experience of active HD-tDCS."
15775571|NCT04650022|Device|Mechanical thrombectomy|Stent retriever for treatment of cerebral arterial occlusions
15775572|NCT04649996|Procedure|Appendectomy|comparison between operative and conservative treatment
15775573|NCT04649983|Biological|CD19 and CD22 targeted CAR-T cells|A single infusion of CD19 and CD22 CAR-T cells will be administered intravenously
15775574|NCT04649970|Procedure|Antegrade double-J stent|After exchanging the nephrostomy catheter over the J-tipped guidewire, 5 F multipurpose (45° tip) diagnostic vascular catheter was inserted. Once the pelvi¬ureteric junction was crossed and the ureter accessed, a straight hydrophilic guidewire and a catheter were used. Then, the cath-eter was advanced into the bladder over the wire, this guidewire was exchanged for an ultra-stiff guidewire, an 8 or 10 F double J ureteral stent was placed over the guidewire, and the safety kit of the stent was removed. A final fluoroscopic image was stored for correcting the stent position.
15775575|NCT04649944|Diagnostic Test|Serological test and phone interview|"Families are interviewed by telephone to gather information about the family cluster (i.e. age and number of cohabitants, their symptoms and swab results, if performed), the subject who tested positive (i.e.sex, age, course of the disease, symptoms suggestive of COVID-19) and children aged between 4 and 16 y.o. (i.e. sex, age, drug therapy and/or chronic diseases, symptoms suggestive of COVID-19).
~Children, young adults and the cohabitant who previously tested positive to the swab undergo a serological test for the detection of IgG and IgM antibodies for Sars-Cov-2."
15775576|NCT04649931|Device|Ion Mobility Spectrometry (IMS)|Two breathing gas samples will be taken from each study participant using ion mobility spectrometry with an ultrasound-based spirometer. The total sampling time is 1 minute (at least 5-7 breath takes) following an analysis time of 5-12 minutes.
15775577|NCT04649918|Other|pulmonary rehabilitation|COVID 19 patients perform a standardized 3-week inpatient pulmonary rehabilitation program
15775578|NCT04649905|Procedure|Surgical Treatment|Surgical standard-of-care treatment for knee OCD
15775579|NCT04649905|Procedure|Nonoperative Treatment|Nonoperative standard-of-care treatment for knee OCD
15775580|NCT04649892|Drug|Naltrexone|Patients will receive daily doses of Naltrexone, starting at 50mg and increasing 25mg per week until reaching 200mg or the maximum tolerated by the patient
15775581|NCT04649892|Drug|Placebo|Patients will receive daily doses placebo matching tablets for the 12 weeks of the study. Throughout this period, possible adverse effects will be monitored weekly.
15775582|NCT04649892|Behavioral|Psychoeducational|Participants will also attend to 4 sessions of psychoeducational intervention in weeks 2, 4, 6, and 8
15775583|NCT04649892|Device|Eye-tracking|"The attentional bias of the participants will be assessed using the Eye-tracking device in 4 moments throughout the study:
~Before taking the first dose of naltrexone or placebo.
~One hour after taking the first dose of naltrexone or placebo.
~One week after continuous and daily use of naltrexone or placebo.
~At the end of the intervention, after 12 weeks of continuous and daily use of naltrexone or placebo."
15775584|NCT04649879|Biological|SARS-CoV-2 convalescent plasma|Participants will receive 200 ml convalescent plasma daily until SARS-CoV-2 is no longer detectable in the blood up to a maximum of 10 CP infusions. CP will be given as a slow infusion over 2 hours. CP neutralization titre of ≥ 1/640 or an ELISA reactivity against the Spike protein of SARS-CoV-2 by the Euroimmun commercial assay >9 is desired. New antibody tests are under development and can be used instead if equivalence to neutralization or Euroimmun ELISA is demonstrated.
15775586|NCT04649866|Diagnostic Test|plethysmography|"Forearm blood flow (FBF) measurements in both arms will be made using venous occlusion strain-gauge plethysmography prior to the initiation of any intra-arterial infusions. All FBF measurements will be expressed as mL/min per 100-1 mL forearm volume according to prior studies and the Whitney method.1, 2 Resting baseline FBF will be measured at least 30 minutes after venous and arterial catheter placement to ensure that blood flows in the cannulated arms are stabilized. We will measure FBF during the last 2 minutes of each infusion period. Infusions of individual vasoactive medications will occur over a 15-minute interval. There will be a 25-minute washout between vasoactive medications. Cumulative dose response curves will be constructed over 5-minute incremental infusions. We will proceed in the following order:
~SNP 0.8, 1.6 and 3.2 mcg/min
~ACh 7.5, 15 and 30 mcg/min
~Normal saline"
15775587|NCT04649853|Other|Standardized nursing care|All patients will receive standardized evidence based nursing care
15775588|NCT04649840|Diagnostic Test|Humoral and cellular immunity|Humoral (IgG) and cellular (antigen-specific cells) immunity
15775589|NCT04649827|Other|Clinical Observation|This is an observational study, so there are no interventions. Investigators will collect data about demographics, comorbidities, medications, and other risk factors such as the severity of disease at admission, need for advanced life support, need for invasive mechanical ventilation and main outcomes during hospitalization.
15775590|NCT04649814|Other|Questionnaire|Questionnaire for all, interview for part of the respondents.
15775591|NCT04649801|Procedure|Atrial fibrillation ablation|Catheter ablation
15775592|NCT04649788|Device|Ultrasound-guided axillary vein access|Venous access is performed through ultrasound-guided axillary vein puncture and Seldinger technique. After venous access is obtained, a guide-wire is advanced through the access needle, and the tip of the guide-wire is positioned in the right cardiac atrium.
15775593|NCT04649788|Device|Cephalic vein access|Venous access is performed through a cephalic vein cutdown approach. After venous access is obtained, a guide-wire is advanced and the tip of the guide-wire is positioned in the right cardiac atrium.
15775594|NCT04649775|Device|AirFLO2|Mask device
15775595|NCT04649762|Behavioral|activating consciousness technique (hypnosis)|activating consciousness technique (hypnosis)
15775596|NCT04649749|Diagnostic Test|MRI|MRI scan
15775597|NCT04649736|Other|Respiratory and psychological rehabilitation|"Respiratory rehabilitation consists of 12 sessions of respiratory and physical exercises that patients perform at home with the help of a physiotherapist. Sessions have 1 hour of duration and are performing twice a week. Exercises include (1) Training of the respiratory muscles through pursed-lip breaths. (2) Effective cough exercises. (3) Diaphragmatic contractions in a supine position with a lightweight placed on the anterior abdominal wall. (4) Stretching exercise of extremities and the back.
~The psychological support consists of 1 session to make the psychological history of the participant, and 6 sessions of emotion-centered problem-solving therapy, with cognitive-behavioral components and psychological management of emergencies and crises. These sessions have a 1-hour duration and are telephone-provided once a week by psychologists following the guidelines of the Inter-Agency Standing Committee on Mental Health and Psychosocial Support in Humanitarian and Disaster Emergencies."
15775598|NCT04649723|Drug|Rifampin|single oral dose, 600 mg, fasted.
15775599|NCT04649723|Drug|SHR1459|single oral dose, 200 mg, fasted.
15775600|NCT04649710|Biological|BMS-986036|Specified dose on specified days
15775601|NCT04649710|Other|Placebo|Specified dose on specified days
15775602|NCT04649697|Drug|Rebamipide|A mucosal protection drug developed in Japan for the treatment of gastritis and gastric ulcer.
15775603|NCT04649697|Drug|Nanoparticulated Rebamipide|A mucosal protection drug developed in Japan for the treatment of gastritis and gastric ulcer will be used in nanotechnology.
15775604|NCT04649697|Drug|Clobetasol Propionate|A corticosteroid drug used as a gold standard for treatment of methotrexate induced oral ulceration.
15775605|NCT04649684|Device|Conventional robot-assisted gait training|They got conventional robot-assisted gait training, guidance force given equally to both limbs, and then gradually reduce the degree of guidance force to the extent that the patient is tolerable equally .during 4- week treatment session
15775606|NCT04649684|Device|Lower CIMT robot-assisted gait training group|They got robot-assisted gait training based on CIMT concept; 100% guidance force is given on the unaffected side and then verbal ques are given not to contract unaffected muscle voluntarily as much as possible are provided, automatically according to the predetermined joint trajectory. In contrast at the affected side, gradually reduce the degree of guidance force to the extent that the patient is tolerable.
15775608|NCT04649658|Behavioral|Prone position|Prone position maintained at least 3 hours/day
15775609|NCT04649645|Other|TOBACCO CIGARETTES|Participants in Arm A will continue smoking their own cigarette brand as usual.
15775610|NCT04649645|Other|COMBUSTION-FREE NICOTINE DELIVERY SYSTEMS (C-F NDS)|Participants in Arm B will trial and familiarize with a selection of C-F NDS in order to choose the product of their preference. They will be trained and counselled on the chosen C-F NDS. Prior to check-out, participants wishing to use a heated tobacco device will receive one kit and a full 2 weeks supply of tobacco sticks of their choice (they will receive a number of tobacco sticks per day corresponding to the number of cigarettes smoked at baseline); those wishing to use a vaping product will receive one vaping kit and a full 2 weeks supply of e-liquids of their choice (they will receive twelve 10 ml refill containers).
15775611|NCT04649645|Other|NOT SMOKING|Participants in Arm C will continue not smoking or use any form of tobacco or nicotine-containing products.
15775612|NCT04649619|Procedure|GASTRIC BYPASS MODIFIED IN ROUX-EN-Y AS A THERAPEUTIC OPTION IN PATIENTS WITH INDICATION OF BARIATRIC AND / OR METABOLIC SURGERY|"Roux-en-Y gastric bypass:
~Stapling and reduction of the gastric chamber of approximately 18 cm, followed by anastomosis with a deviated bowel, and another bowel anastomosis with a bowel in a lower portion, for deviation of biliopancreatic secretions. Maintenance of a gastro-gastric communication of approximately 1 cm between the functional gastric pouch and the excluded stomach for endoscopic access."
15775613|NCT04649593|Dietary Supplement|Samarin|Half of the group with a high AFL value will have a glass of Samarin to drink
15775614|NCT04649554|Device|Exablate treatment|Ablation
15775615|NCT04649541|Drug|MRX-8|novel semi-synthetic polymyxin B analog.
15775618|NCT04649528|Device|Effective endurance 4x4 training - APP|Exercise intervention utilizing 4x4min aerobic high-intensity interval training
15775619|NCT04649515|Biological|TY027|TY027 Injection, (100 mg/5 mL/Vial), SARS-CoV-2 Monoclonal Antibody (mAb) - 1,500 mg of TY027
15775620|NCT04649515|Biological|TY027|TY027 Injection, (100 mg/5 mL/Vial), SARS-CoV-2 Monoclonal Antibody (mAb) - 2,000 mg of TY027
15775621|NCT04649515|Other|0.9% saline|Placebo
15775622|NCT04649502|Combination Product|Metformin|Metformin in combination with doxycycline
15775623|NCT04649489|Drug|Atezolizumab|atezolizumab 1200mg and bevacizumab 15mg/kg
15775624|NCT04649489|Procedure|Surgery|hepatic resection with post-operative atezolizumab 1200mg and bevacizumab 15mg/kg
15775625|NCT04649476|Drug|Camrelizumab|The participants will receive camrelizumab (200 mg) intravenous infusion each 2-week cycle for 3 cycles prior to surgery.
15775626|NCT04649476|Drug|Camrelizumanb plus TPF|The participants will receive camrelizumab (200 mg) through intravenous infusion each 2-week cycle, and docetaxel (T) 75 mg/m2, cisplatin (P) 75 mg/m2, 5-Fluorouracil (F) 750 mg/m2 through intravenous infusion each 3-week cycle for 2 cycles.
15775627|NCT04649463|Diagnostic Test|Open ABPM results|ABPM results were used in the decision making for adjustments in antihypertensive medication at follow up visit.
15775628|NCT04649450|Other|Music|Participants in the music group will receive headphones with music 30 minutes before surgery. Patients will be able to choose music from a preselected list composed by a team consisting of researchers and dedicated music therapists. The headphones will be removed just before entering the operating room. Once in the operating room they will receive earphones after intubation, compatible with the Mayfield and site of operation. The intraoperative music intervention will be continued during the surgical procedure and discontinued just before detubation. The duration of the intraoperative music intervention depends on the duration of surgery and will be documented. After surgery, during recovery at the post-operative care unit (PACU) another 30 minutes of music through headphones will be given. The following 3 days at the neurosurgical ward they will receive music twice a day for 30 minutes.
15775629|NCT04649437|Diagnostic Test|Quantitative sensory testing|Quantitative sensory testing recordings will be collected by pressure algometry Assessment of temporal summation of pressure pain and conditioning pain modulation will be used to investigate the involvement of pain sensitization.
15775630|NCT04649424|Device|CanSwab|New nasopharyngeal swab design.
15775631|NCT04649411|Drug|ferric citrate|oral tablets
15775632|NCT04649411|Drug|standard of care|administered per the approved label and at the Investigator's discretion
15775633|NCT04649398|Drug|Nimodipine|If application of nimodipine is clinically indicated patients will be enrolled in the study protocol according to the inclusion and exclusion criteria. The clinically appropriate route of administration will be administered according to the recommended regimen of the study drug; i.e. within the first 10-14 days intra-venous infusion and thereafter oral administration. Intra-arterial infusion will be performed due to severe cerebral vasospasm with impending stroke.
15775634|NCT04649385|Drug|BGB-15025|Administered orally once daily (QD)
15775635|NCT04649385|Drug|Tislelizumab|Administered 200 mg intravenous (IV) infusion
15775636|NCT04649372|Procedure|EndoVE|On the day of the procedure, a review of any changes which occurred since the pre-study visit will be conducted. The patient will be placed under general anaesthesia or sedated before Bleomycin will be delivered intravenously. The patient will then be treated endoscopically with the EndoVE device. The EndoVE procedure should take no longer than 30 minutes.
15775638|NCT04649320|Other|questionnaire|"13-item questionnaire about cancer patient's distress and everyday life,
~EORTC-QLQ-C30"
15775639|NCT04649307|Behavioral|MI-CBT|Education, Interoceptive exposure, Exposure in-vivo, Behavioral activation, Relapse prevention
15775640|NCT04649281|Device|Accelerometry|Recording of sleep and physical activity by accelerometry during one week.
15775641|NCT04649268|Device|Group B|The C2 CARE C2 Physio 2019.2 has been developed for physiotherapy rehabilitation purposes including vestibular disorders. Virtual reality environments will be provided via the VR Oculus Quest headset as part of the OKS exposure incorporated within a customised VRT programme. Participants will attend 45 minute individualised supervised sessions once weekly for 8 weeks. Participants in this rehabilitation group will also have a home-based exercise programme to practise on days not attending clinic. The home-based programme will incorporate customised VRT exercises with exposure to VR environments using the VR Oculus Quest headset.
15775642|NCT04649268|Other|Group A|Optokinetic stimulation treatment delivered through visual motion DVDs. Individualised 45 minute supervised sessions will occur for this group also once weekly for 8 weeks together with a home-based customised VRT programme incorporation the DVD to practise on days not attending clinic. Participants will have to use the OKS DVD for their exercises at home daily for 8 weeks as part of the prescribed home exercise programme.
15775643|NCT04649255|Device|Liquid Embolic|Lava Liquid Embolic System (LES)
15775644|NCT04649242|Drug|Rimegepant/BHV3000|BHV3000 (rimegepant) 75 mg or 50 mg ODT
15775645|NCT04649242|Drug|Matching placebo|Matching 75 mg or 50 mg ODT placebo
15775646|NCT04649229|Drug|LCZ 696|Treatment with LCZ696 is unblinded in this study. After the two acute study days, subjects will be provided LCZ696 50 mg bid for two weeks. At the end of those two weeks subjects will report to the Clinical Research Center (CRC) for a dose escalation visit. If their tolerance, blood pressure, potassium, and eGFR meet escalation criteria they will be given LCZ696 100 mg bid for three weeks. (If they do not meet escalation criteria they will be continued on LCZ696 50 mg bid.) After three weeks, they will return to the CRC for the next escalation visit. If they meet criteria for escalation they will be given LCZ 200 mg bid for ten days. (If they do not meet escalation criteria they will be continued on the highest tolerated dose).
15775647|NCT04649229|Drug|Placebo|Placebo or aprepitant 120 mg will be given orally on study days 1 and 2 and again on study days 3 and 4
15775648|NCT04649229|Drug|Para-aminohippurate|Para-aminohippurate (PAH) will be given at a dose of 8 mg/kg loading dose followed by a 12 mg/min steady-state infusion during each study day.
15775649|NCT04649229|Drug|Iohexol|Iohexol will be given as 5 mL of iohexol solution (3.235 g iohexol) intravenously on each study day.
15775650|NCT04649229|Drug|Aprepitant|Placebo or aprepitant 120 mg will be given orally on study days 1 and 2 and again on study days 3 and 4
15775651|NCT04649216|Drug|PCO371|PCO371 Capsule
15775654|NCT04649203|Drug|Cytoflavin (Inosine + Nicotinamide + Riboflavin + Succinic Acid)|The study drug will be administered in two phases: intravenous infusion of study drug for 10 days followed by oral administration of study drug for 75 days. Thus, the total duration of the study therapy is 12 weeks.
15775655|NCT04649203|Drug|Placebo|The placebo comparator will be administered in two phases: intravenous infusion of placebo solution for 10 days followed by oral administration of placebo pills for 75 days. Thus, the total duration of the study therapy is 12 weeks.
15775656|NCT04649190|Device|TAVI|Coronary access for PCI after TAVI
15775657|NCT04649177|Device|Ocular surface optical coherence tomography|EYEdeal Scanning technology enables rapid measurement of the corneal and scleral topography which provides data for an automated sequence to fit PROSE devices
15775658|NCT04649164|Behavioral|Peer mentor support and caregiver intervention|Sixteen-week modular curriculum with printed/online workbook, additional resources, and weekly phone discussion with Lewy Body Dementia peer mentor.
15775659|NCT04649164|Other|Focus group to provide feedback on educational materials and mentoring program|Participation in a 2-3 hour focus group to review pilot and revised materials and provide feedback
15775660|NCT04649151|Biological|mRNA-1273|Sterile liquid for injection
15775661|NCT04649151|Biological|Placebo|0.9% sodium chloride (normal saline) injection
15775662|NCT04649125|Radiation|dose escalation|single fraction dose escalation to the tumour
15775663|NCT04649112|Genetic|PBCAR19B|Single dose of Allogeneic Anti-CD19 CAR T cells will be injected/infused
15775664|NCT04649099|Device|Leaflex™ Performer|A transfemoral catheter designed to treat calcific aortic stenosis by scoring the calcification in the aortic valve leaflets.
15775665|NCT04649086|Other|Rehabilitation by Eccentric exercises|Participants will perform 24 exercises sessions (30 minutes) with cycloergometer in eccentric mode (while resisting against self-paced pedaling), inducing a greater muscular hypertrophy as compared with concentric mode, the mechanical stimulation being 3 to 4 times greater at the same level metabolic stimulation.
15775666|NCT04649086|Other|Rehabilitation by Concentric exercises|The control group (concentric) will perform exercise training at an intensity of 60% of the reserve heart rate determined during an initial cardiorespiratory test. The power will be adjusted weekly to stay within the target heart rate range.
15775667|NCT04649073|Biological|OPC-415|OPC-415 (up to 1×10^7cells/kg) On 2 days
15775668|NCT04649060|Drug|Melphalan Flufenamide|30 mg intravenous (i.v.) infusion
15775669|NCT04649060|Drug|Dexamethasone|40 mg weekly (if ≥75 years 20 mg weekly). Oral tablets
15775670|NCT04649060|Drug|Daratumumab|1800 mg subcutaneous injection
15775671|NCT04649047|Behavioral|Goal-oriented episodic future thinking|All participants will receive a 3-week web-based intervention plus individual health coaching. The intervention topics include stress management, healthy eating, and physical activity
15775672|NCT04649034|Diagnostic Test|Doppler echocardiogram exam|A complete echocardiographic study will be performed at enrollment. The echocardiographic images will be acquired as clinically recommended. The protocol will include the acquisition of 1) 2D images in parasternal axis long and short axis; 2) 2D and Doppler tissue images in the apical planes of 4, 2 and 3 chambers; 3) Pulsed, continuous and color Doppler M (DCMM) of transmitral LV flow and LV ejection; 4) 3-Chamber apical plane with and without color Doppler; and 5) 3D LV images. DCMM images will be obtained from the apical window using 4 and 5 chamber planes. Blood flow velocity will be obtained using Color and Gray mode in the 3 chamber view during 5-10 beats in apnea.
15775673|NCT04649034|Diagnostic Test|Cardiac magnetic resonance|"A cardiac MR will be acquired within 10 days after the enrollment. The protocol includes the following sequences: cine mode of short axis from LV base to apex and 2-3-4 chambers. 3D sequence of late enhancement of inversion-recovery. Images will be acquired after 3 min and 10 min of the administration of a total of 0.2 mmol / kg of Prohance®. Intraventricular thrombosis will be monitored. Phase contrast sequences in three orthogonal planes will be acquired. Morphological parameters of LV function (LVEF), contractility (Wall Motion Score ) and sphericity index will be measured."
15775674|NCT04649034|Diagnostic Test|Brain magnetic resonance|A brain MR will be acquired within 10 days after the enrollment. Axial, sagittal and coronal spin echo sequence in T1, axial images in diffusion sequences (DWI), enhanced spin echo T2 and FLAIR (fluid-attenuated inversion recovery) sequences shall be obtained. A cerebral infarction will be positive when finding the presence of a focal lesion of> 3 mm in diameter that meets one of these three characteristics: (1) high signal on isotropic DWI images and low signal on the apparent coefficient map Broadcast (ADC). (2) Cavitary lesion hyperintense on T2, with no signal (or low) in the FLAIR sequence. (3) Hyperintense lesion T2 / T1 hypointense with prior distribution defect known or new in a follow-up study.
15775675|NCT04649034|Diagnostic Test|Coagulation blood test|5 ml of peripheral blood will be obtained for assessment of prothrombotic markers at enrollment.
15775676|NCT04649034|Diagnostic Test|Holter monitoring|At inclusion all patients will carry a Holter device for 24 hours to ensure absence of atrial fibrillation
15775677|NCT04649021|Biological|BNT162b2|Intramuscular injection
15775678|NCT04649021|Other|Placebo|Intramuscular injection
15775679|NCT04649008|Diagnostic Test|3T Magnetic Resonance Imaging|Magnetic resonance imaging acquired at a field strength of 3 Tesla.
15775680|NCT04649008|Diagnostic Test|Intracranial electroencephalography recordings|Epilepsy patients may undergo implantation of intracranial electroencephalography (iEEG) electrodes for localization of epileptogenic foci, which also provide a means to record localized brain activity during memory or other tasks for research purposes.
15775681|NCT04649008|Diagnostic Test|7T Magnetic Resonance Imaging|Magnetic resonance imaging acquired at a field strength of 7 Tesla.
15775682|NCT04648995|Device|High energy (UltraPulse)|Half of the face that receives low energy, their central base of boxcar scar will be treated with 30mJ, while shoulder of scar will be treated with 60 mJ
15775683|NCT04648995|Device|Low energy (UltraPulse)|Half of the face that receives low energy, their central base of boxcar scar will be treated with 20mJ, while shoulder of scar will be treated with 50 mJ
15775684|NCT04648982|Other|Admission to inpatient psychiatric unit|All persons in the study are hospitalized at the only inpatient mental health hospital in Rwanda - Ndera. Data will be collected when the person is being discharged.
15775685|NCT04648969|Drug|kisspeptin 112-121|20 intravenous doses of kisspeptin 112-121 (4 different doses of kisspeptin (randomized) in 5 sets)
15775686|NCT04648969|Drug|GnRH|1 intravenous dose of GnRH
15775687|NCT04648956|Other|Standard treatment|Participants shall fill the ICOAP-Ar questionnaire three times within one month in addition to other questionnaires including the KOOS/HOOS, and the Global Rating of Change Scale (GRoC). The first two times will be within a time frame of 48-72 hours. The third time will be after one month.
15775688|NCT04648943|Procedure|Ex-Press mini shunt insertion|
15775689|NCT04648943|Procedure|Trabeculectomy|
15775690|NCT04648930|Drug|Xolair|There is no treatment allocation. Patients administered Xolair by prescription that have started before inclusion of the patient into the study will be enrolled.
15775691|NCT04648917|Drug|Caffeic acid|40 patients will receive coffeic acid treatment: 100-200mg, tid, po, 2 weeks treated then 1 week black interval(weight >50kg, 200mg per time, weight < or =50kg, 100mg per time)
15775692|NCT04648904|Radiation|Radiotherapy|A total dose of 26 Gy in 5 fractions will be given once daily over 5 consecutive weekdays (or within 10 consecutive weekday to allow for treatment delays, interruptions, logistical problems, scheduling issues and weekends/holidays).
15775693|NCT04648891|Drug|Lidocaine|Subcutaneous lidocaine injection prior to laryngeal injection
15775694|NCT04648891|Device|Vibrating wand|Concomitant use of vibrating wand during laryngeal injection
15775695|NCT04648891|Other|Control|Laryngeal injection without additional anesthesia
15775696|NCT04648878|Other|Hybrid combination of physical therapy and powered exoskeleton|18 alternating visits of conventional physical therapy and powered exoskeleton gait training with a wearable robotic powered exoskeleton , three times a week for approximately 6 weeks
15775697|NCT04648878|Other|Powered Exoskeleton Only|18 visits of powered exoskelton only, three times a week for approximately 6 weeks
15775698|NCT04648878|Other|Physical Therapy only|18 visits of physical therapy only, three times a week for approximately 6 weeks
15775699|NCT04648865|Drug|LY3537031|Administered SC.
15775700|NCT04648865|Drug|Placebo|Administered SC.
15775701|NCT04648852|Other|Heart failure risk estimation|Evaluation by heart failure risk score
15775705|NCT04648813|Drug|tiotropium bromide monohydrate (Spiriva Respimat)|administered daily, 2 inhalations/5mcg per dose for a total of 8 doses
15775706|NCT04648813|Drug|matching placebo|administered daily, 2 inhalations per dose for a total of 8 doses
15775707|NCT04648800|Drug|BCG-10 vaccine|"The BCG-10 anti-tuberculosis vaccine
~powder and solvent for preparing a suspension for intradermal injections of Vaccinum tuberculosis (BCG) cryodesiccatum;
~lyophilised BCG vaccine
~one dose (0.1 ml) contains 50 micrograms of half-dried mass of BCG mycobacteria, which corresponds to 150,000 - 600,000 of live BCG bacilli- the Brazilian Moreau sub-strain."
15775708|NCT04648800|Drug|0.9% saline|0.9% saline
15775709|NCT04648787|Behavioral|family-integrated care|One week after admission, the parents of premature infants were informed by telephone one day in advance to enter the ward for family participation nursing, and the guidance of daily life nursing for premature infants was given on the same day, including hand hygiene, breast feeding, pacification, changing diapers, bathing and establishment of parent-child relationship. Before discharge, theparents of premature infants should be informed by telephone one day in advance to enter the ward again for family participation nursing, and half a day's guidance was given, including observation and treatment of common symptoms and signs, guidance of home safety prevention and learning to write diary of premature infants.
15775710|NCT04648787|Behavioral|traditional nursing|In hospital education: the health education manual for premature infants will be issued at the time of discharge; the patient's condition will be answered by telephone from 14:00 to 16:00 every day.
15775711|NCT04648774|Procedure|Serratus anterior plane (SAP) block|With the patient in supine position, an ultrasound transducer will be used to find the 4th rib in the mid-axillary line. A 17g touhy needle will be introduced in-plane in an inferior to superior direction until its tip rests between the serratus anterior muscle and the 4th rib or the 3rd external intercostal muscle. A bolus of study drug 10ml (either ropivacaine 0.2% or normal saline) will be delivered though the needle. A 18g multiholed catheter will be inserted and secured to the patients' skin with adhesive dressings. A further 10ml of study drug will be administered through the catheter. The same procedure will be followed on the contralateral side. The study drug will be administered by programmed intermittent bolus (PIB) 10ml every 2 hours to each side in a staggered, alternating fashion. The PIB study drug will to be continued for 72 hours post-insertion.
15775712|NCT04648774|Procedure|Normal saline placebo|Patients in both groups will receive the standard of care analgesic medications in the cardiovascular intensive care unit and the ward.
15775713|NCT04648761|Biological|OPTIMAL algorithm|The OPTIMAL algorithm titrates anti IL 5 treatment by addjusting the intervals between injections by FEV1, blood eosinophils and exacerbations.
15775714|NCT04648735|Other|driving evaluation and practice|"The participants completed the actual driving with a licensed driving instructor on the passenger side in the car and with a dual-control, automatic-transmission car.
~Each participant completed three runs of the same route. The first twos were practices to familiarize themselves with the course. The driving instructor graded them on the third run. Each trial took about 10 minutes. The participants were scored according to governmental driver test guidelines. Scoring on individual driving maneuver is weighted. Depending on the type of error, 8, 16 or 32 points were deducted from 100, for example, 32 points for getting too close to pedestrian lane, running a red light or railroad crossing, and 8 points for stopping in S-curve forward and backward. 70 or above is considered as a pass. The occupational therapists in the backseat recorded driving behaviors, including whether the driver checked rear and side mirrors, excessive sweating, distractibility, number of adjustments, etc."
15775767|NCT04648254|Drug|Q702|The study drug Q702 will be administered once daily by mouth on Days 1 through 7 and Days 15 through 21 of every treatment cycle.
15775768|NCT04648241|Biological|TBE vaccine 0.5 mL|TBE vaccine 0.5 mL (intramuscular injection).
15775715|NCT04648722|Procedure|Hemithyroidectomy|We investigated patients who received a hemithyroidectomy at the Department of General Surgery, Division of Endocrine Surgery and a follow-up visit (3-12 months post-surgery) at the thyroid outpatient clinic of the Department of Endocrinology and Metabolism, Medical University of Vienna between 1994 and 2018.
15775716|NCT04648709|Diagnostic Test|ELISPOT|measure of immune response by ELISPOT
15775717|NCT04648709|Diagnostic Test|QUANTIFERON|measure of immune response by QUANTIFERON
15775720|NCT04648683|Behavioral|Postsurgical Telehealth Mindfulness Program|Participants who enroll and complete lumbar spine surgery will participate in a one-on-one telehealth-delivered (online with audio and video) mindfulness intervention with a trained mindfulness therapist. The intervention is adapted from mindfulness-based cognitive therapy and includes eight, weekly sessions lasting 75 minutes each (except the first session which lasts 90 minutes).
15775721|NCT04648670|Behavioral|Cognitive stimulation|The intervention was applied to the experimental group and consisted in 10 sessions of 45 minutes/week during 10 weeks. Each session included four parts: (a) Reality orientation therapy, (b) activities related to memory, orientation, language, praxis, gnosis, calculation, perception, reasoning, visual attention, and executive functions, (c) individual practical exercises and (d) correction of the practical exercises..
15775722|NCT04648657|Device|Lung Ultrasound|Echography of Lungs based on artifacts study
15775723|NCT04648657|Device|Electric impedance tomography|Low alternating electrical currents (usually <5 milliampere at 50-80 kHz) applied through different pair of electrodes on thorax
15775724|NCT04648644|Other|Application of ERAS protocol|Application of a standardized ERAS protocol for the perioperative perioperative management of patients undergoing emergency surgery
15775725|NCT04648631|Device|antibiofilm surfactant wound gel (ABWG)|ABWG is a hydro-gel applied topically using a tongue depressor
15775726|NCT04648605|Other|Post traumatic stress disorder questionnaire|Parents of hospitalized children in pediatric resuscitation carry out a validated questionnaire that validates the post-traumatic stress level by a score.
15775727|NCT04648592|Dietary Supplement|Low salt diet plus sodium chloride supplements|Patients will receive a low salt diet plus salt supplements.
15775728|NCT04648592|Dietary Supplement|Low salt diet plus placebo|Patients will receive a low salt diet plus placebo.
15775729|NCT04648579|Device|Hillrom|Hillrom Connecta solution will record vital signs in an automated way, without the need for human intervention, and activate TRR activation when at least one criteria is met. The frequency of monitoring vital signs will be defined based on the MEWS score.
15775730|NCT04648579|Other|Control|Hospital usual care regarding vital signs collection and TRR activation.
15775731|NCT04648566|Procedure|Intrauterine administration of hCG-activated peripheral blood mononuclear cells|Administration of hCG-activated peripheral blood mononuclear cells in the uterine cavity of the patient
15775732|NCT04648566|Procedure|Intrauterine administration of sperm washing medium|Administration of sperm washing medium instead of PBMC in the uterine cavity of the patient
15775733|NCT04648553|Behavioral|Task-Based Grounding|Three 50 minutes sessions with an interventionist that includes 6 non-punitive components of treatment common in Behavioral Parent Trainings: Education on behavior change, positive one-on-one time between parents and their children, differential attending to positive and negative behaviors, effective praise, giving effective instructions, and using a point and reward system to encourage prosocial behaviors. These components are distilled into 5 skill modules and paired with Task-Based Grounding, which involves a brief restriction of privileges and provides children with the opportunity to end the restriction by completing a prosocial task.
15775734|NCT04648553|Behavioral|Connected Care (Enhanced Treatment as usual)|Two sessions with a facilitator. The facilitator does NOT provide any guidance to the parent on managing their child's behavior, but provides empathy and problem solving to help them find a resource that best fits their needs. It is particularly geared towards helping parents connect with Behavioral Parent Trainings to address the needs of children with oppositional, defiant, or aggressive behaviors.
15775735|NCT04648540|Drug|Dexmedetomidine 0.5 mic/kg/h|"In Group I (OFA) the following drugs will be administered preoperatively:
~Acetaminophen 1 gm and Ketorolac 30 mg in 100 mL i.v. over 10 minutes Dexmedetomidine loading dose of 0.5 mic/kg i.v. over 10 minutes Lidocaine loading dose of 1.5 mg/kg i.v. over 10 minutes
~The following drugs will be administered as a continuous infusion throughout the operation:
~Dexmedetomidine 0.5 mic/kg/h
~Lidocaine 0.5 mg/kg/h
~The following drugs will be administered postoperatively:
~Acetaminophen 1 gm/6h ketorolac 30 mg/8h Pregabalin 150 mg once at night Celecoxib 200 mg/24 hours"
15775736|NCT04648540|Drug|Fentanyl 1 mic/kg/hr|In Group II (OA) patients will receive a continuous infusion of Fentanyl (1 mic/kg/h) Morphine 0.1 mg/kg PRN will be administered every 8 hours for postoperative analgesia
15775737|NCT04648527|Procedure|arthroscopic synovectomy and thermocoagulation|An diagnostic arthroscopy and an arthroscopic synovectomy and thermocoagulation of the dorsal hypertrophic synovial will be performed
15775738|NCT04648514|Procedure|Using of hydraulic lifter device for closed sinus lifting|Using of recent closed minimally invasive technique (hydraulic left technique) by hydraulic lifter device for closed sinus lifting then evaluation of the amount of bone height gain will be done radiographically (by panorama and CBCT) after implant placement for patients with posterior edentulous maxilla .
15775739|NCT04648514|Behavioral|patient satisfaction evaluation after using hydraulic lifter device|Evaluation of patient satisfaction numerically will be done after using hydraulic lift technique by hydraulic lifter device for closed sinus lifting in posterior edentulous maxilla
15775769|NCT04648241|Biological|TBE vaccine 0.25 mL|TBE vaccine 0.25 mL (intramuscular injection).
15775770|NCT04648228|Behavioral|ACT+MBRP|Intervention is behavioral treatment group that combines Acceptance and Commitment Therapy (ACT) with Mindfulness-Based Relapse Prevention. The group focuses on living with long-term pain, ways to complete daily living activities when you experience pain, coping with opioid and other drug cravings, and training in mindfulness practices.
15775814|NCT04647864|Device|Transcatheter Aortic Valve Implantation|Replacement of the aortic valve of the heart through the blood vessels, delivered via one of several access methods.
15775741|NCT04648488|Other|Experimental early mobilisation|early activ assisted exercises treatment
15775742|NCT04648488|Other|Aktive comparator standrad treatmnet|standard treatment with a plaster 3 weeks and then active assisted exercises
15775743|NCT04648475|Biological|CD19 and CD22 targeted CAR-T cells|A single infusion of CD19 and CD22 CAR-T cells will be administered intravenously
15775744|NCT04648462|Other|ProTRAIT|The participants are seen at the outpatient clinic by a physician, physician assistant or trial nurse at standard follow-up times at 2.5, 5, 7.5 and 10 years after radiotherapy.
15775745|NCT04648449|Other|Artificial intelligence on emergency calls|AI listens to all calls to Bergen EMCC, detecting calls regarding possible stroke.
15775746|NCT04648436|Other|Early neurosurgical hematoma evacuation|Early neurosurgical hematoma evacuation (preferably within 2 hours)
15775747|NCT04648436|Other|Conservative treatment (best medical management)|Conservative treatment (best medical management) on the ICU or ward
15775748|NCT04648423|Drug|Sodium Oxybate|solution for oral administration
15775749|NCT04648423|Drug|Placebo|solution for oral administration
15775750|NCT04648410|Other|questionnaire|Members of European Society of Intensive Care will obtain an electronic survey considering their routine clinical practice regarding the administration of systemic corticosteroids among patients with COVID-19 ARDS
15775751|NCT04648397|Other|Low glycaemic load, high fibrous product|Test-lunch of 370 grams of chickpeas, seasoned with a herb- and spice mix to increase palatability. Glycaemic load 18.5. Consumed in duplicate.
15775752|NCT04648397|Other|High glycaemic load, low fibrous product|Test-lunch of 257 grams of brown rice, seasoned with rice-oil and a herb- and spice mix to increase palatability. Glycaemic load 44.9. Consumed in duplicate.
15775753|NCT04648384|Dietary Supplement|Blend Protein Supplementation|Protein supplementation using 20 grams of whey protein or casein mix. Acute Resistance training, 10 sets of 10 reps at 85% of 1Maximum repetition
15775754|NCT04648384|Dietary Supplement|Placebo Supplementation|Placebo supplementation using 20 grams of Maltodextrin. Acute Resistance training, 10 sets of 10 reps at 85% of 1Maximum repetition
15775755|NCT04648384|Other|Resistance Exercise|10 sets of 10 repetitions at 85% of 1 Maximum repetition in leg press exercise
15775756|NCT04648371|Other|Cognitive Remediation and Transcranial Direct Current Stimulation|"Cognitive Remediation (CR) is a well-established psychosocial group intervention that aims to improve neurocognitive abilities such as memory performance, executive functioning, processing speed, and attention.
~Transcranial Direct Current Stimulation (tDCS) is a non-invasive brain stimulation method that can be safely administered to awake outpatients. It does not require general anesthesia or surgical implantation. It utilizes low intensity electrical current (e.g., 2 mA) either to increase cortical excitability with an anodal electrode or to suppress cortical excitability with a cathodal electrode."
15775757|NCT04648358|Drug|Bupivacaine|The control group will receive scalp nerve blocks with 0.5% bupivacaine with epinephrine at 1:200,000, plus normal saline 1 ml. The anesthesiologist will perform scalp nerve blocks based on the group allocation 10 mins before the incision. Scalp nerve blocks will be performed according to the technique previously described by Pinosky et al.
15775758|NCT04648358|Drug|Dexamethasone combined with bupivacaine|The DEX4mg group will receive scalp nerve blocks with 0.5% bupivacaine with epinephrine at 1:200,000, plus 4 mg dexamethasone (1 ml). The anesthesiologist will perform scalp nerve blocks based on the group allocation 10 mins before the incision. Scalp nerve blocks will be performed according to the technique previously described by Pinosky et al.
15775759|NCT04648345|Procedure|Erector spinal plane block|After induction of general anesthesia, pre-operative ultrasound-guided bilateral erector spinae plane block/ vertebral side block will be performed in the ESPB/VSB group. Local block will be performed at the surgical incisions after the surgery under general anesthesia. All the intervention will be performed without patients' awareness.
15775760|NCT04648332|Drug|Bupivacaine Hydrochloride|compartment psoas block
15775761|NCT04648319|Drug|BMS-936558|BMS-936558 followed by 30 grays of 3 to 5 fractions of high dose SBRT followed by monthly BMS-936558 until progression
15775762|NCT04648306|Device|Prophylactic Impella support for a non-emergent PCI|Impella percutaneous mechanical circulatory support is placed via the femoral or axillary artery prior to a non-emergent PCI in patients at high risk for periprocedural complications including hemodynamic collapse.
15775763|NCT04648293|Device|Starling|Starling is a portable, non-invasive, cardiac output detector system. The Starling monitor measures the cardiac output by employing electrical bioreactance that measures the electrical characteristics of a volume of tissue and fluid. In the case of cardiac output measurements, the relevant tissue includes the heart and the immediate surrounding volume of the thorax. The relevant fluid is blood. Baxter Healthcare's Starling electrode is a double electrode sensor. Within each sensor, one electrode is used to transmit a high frequency sine wave into the body, while the resulting voltage is measured at the adjacent electrode. Four electrodes are placed at specific areas of the thorax, the impedance to the current flow calculated, and the electrical bioreactance waveform constructed. This information is used to determine cardiac output, and measures and displays associated hemodynamic parameters based on calculations of measurements already incorporated into the Starling device.
15775764|NCT04648280|Drug|Fostemsavir|fostemsavir in combination with optimized background therapy (OBT) in HIV-1 infected children and adolescents who are failing their current combination antiretroviral therapy (cART) and have dual- or triple-class ARV resistance
15775765|NCT04648267|Other|Cast and bolster placement duration|The intervention is increasing the duration of cast and bolster placement on split thickness skin graft sites.
15775766|NCT04648267|Other|Standard of care|This will be standard of care - the patient will have his cast and bolster on for 5-7 days
15775811|NCT04647890|Drug|Placebo|Two placebo capsules once daily for 12 weeks
15775771|NCT04648228|Behavioral|Education control|Education control is behavioral treatment group that combines pain patient education with opioid and other drug education. The group focuses on experiences of long-term pain, instructions on how to function with this pain, and facts about opioids and other drugs.
15775772|NCT04648215|Other|lavender oil|aromatherapy--two drops applied to a 2x2 gauze and pinned to subject's gown
15775773|NCT04648215|Other|Grapeseed Oil|aromatherapy--two drops applied to a 2 X 2 gauze and pinned to subject's gown
15775774|NCT04648202|Drug|FS120|Dosing of participants will occur intravenously (IV), at a fixed dose in treatment cycles once every 4 weeks (Q4W) until confirmed progressive disease (CPD)/immune-confirmed progressive disease (iCPD) or unacceptable toxicity.
15775776|NCT04648176|Device|Moses technology|Using Holmium laser with Moses technology or conventional one
15775777|NCT04648150|Device|Evaluation of a millimeter wave emission bracelet for improving Parkinson's disease symptoms|Evaluation of a millimeter wave emission bracelet -type medical device for improving Parkinson's disease symptoms: multicenter, double-blind randomized controlled trial
15775778|NCT04648137|Diagnostic Test|study intervention: 3,4-methylenedioxymethamphetamine (MDMA, ecstasy)|single administration of MDMA (100mg): 3,4-methylenedioxymethamphetamine (MDMA, ecstasy) will be prepared as gelatin capsules with mannitol as the filler. MDMA will be administered in a single absolute dose of 100 mg corresponding to a medium high dose of (mean ± SD) 1.3 ± 0.3 mg/kg body weight.
15775779|NCT04648137|Diagnostic Test|Control intervention: Placebo|Identical placebo (only mannitol) capsules
15775780|NCT04648124|Device|IRMf-r (séquence resting state)|Functional MRI of functional brain networks
15775781|NCT04648111|Diagnostic Test|Vital sign measurement|Vital signs measurement will be obtained by the research staff using hospital standard medical devices and the Anura Research App will also be used to measure vital signs. Measurement will take place before surgery and post surgery (1 ±2hrs and 2 ±4hrs after surgery).
15775782|NCT04648098|Other|Discharge training and telephone counseling|"The discharge training was given by using different teaching methods in the form of verbal expression, demonstration, and question and answer. The care guide prepared by the researchers in line with the literature was used as a training material for stroke patients and their caregivers.The training varied according to the learning level of individuals but took an average of 40-60 minutes.
~Consultation service was given to the caregivers one week after discharge and once a month for three months by telephone call."
15775784|NCT04648072|Procedure|Adductor Canal Block|As previously described.
15775785|NCT04648072|Procedure|Periarticular Injection|As previously described.
15775786|NCT04648059|Diagnostic Test|Blood sampling|Blood sampling will be performed to allow analyses of epigenetic markers
15775787|NCT04648046|Drug|Cyclophosphamide|Non-ablative conditioning with cyclophosphamide.
15775788|NCT04648046|Biological|LVgp120duoCAR-T cells, low dose|A single dose of 3 x 10^5 cells/kg LVgp120duoCAR-T cells will be infused.
15775789|NCT04648046|Biological|LVgp120duoCAR-T cells, high dose|A single dose of 1 x 10^6 cells/kg LVgp120duoCAR-T cells will be infused.
15775790|NCT04648046|Other|Analytic Treatment Interruption|HIV antiretroviral therapy medications will be paused.
15775791|NCT04648033|Drug|Atovaquone Oral Suspension|Atovaquone, cisplatin and vinorelbine are all considered Investigational Medicinal Products (IMPs) in this trial due to the investigation of these drugs in a novel combination. Patients will be allocated one of four doses of atovaquone: 450 mg, 600 mg, 675 mg or 750 mg (all doses PO BD).
15775792|NCT04648033|Drug|Standard of care chemotherapy|Atovaquone, cisplatin and vinorelbine are all considered Investigational Medicinal Products (IMPs) in this trial due to the investigation of these drugs in a novel combination. Patients will receive two 21-day cycles of cisplatin and vinorelbine chemotherapy, comprising 80 mg/m2 cisplatin on days 1 & 22 of their CRT treatment and 15 mg/m2 vinorelbine on days 1, 8, 22 & 29.
15775793|NCT04648033|Radiation|Standard of care radiotherapy|Thoracic radiotherapy will commence on day one of chemotherapy and be delivered in 66 Gy in 33 fractions, once daily, 5 days a week (Monday-Friday) for 6.5 weeks.
15775794|NCT04648020|Drug|Clonidine HCl Mucoadhesive Buccal Tablet|100 μg of clonidine per tablet
15775795|NCT04648020|Drug|Placebo Mucoadhesive Buccal Tablet|Placebo
15775796|NCT04648007|Diagnostic Test|Kaihani Score|Assessment of neuromodulatory chemicals in peripheral blood plasma samples.
15775797|NCT04647994|Diagnostic Test|SARS-CoV-2 serology|Serology test of SARS-CoV-2 for pregnant women
15775798|NCT04647981|Other|Xpert® Bladder Cancer Monitor Test|The urine sample is analyzed with the Xpert® Bladder Cancer Monitor test.
15775799|NCT04647968|Procedure|Primary closure of tracheo-cutaneous fistula|This procedure will follow protocoled steps. It consists of a sutured closure of the tracheotomy following local anesthesia, done at bedside.
15775800|NCT04647968|Procedure|Secondary closure of tracheo-cutaneous fistula|This procedure will follow protocoled steps. It consists of removing the tracheotomy canula and applying ointment and an Elastoplast on the site, which will be changed regularly until full healing of the wound.
15775801|NCT04647955|Drug|Itopride|Itopride is a D2 antagonist and cholinesterase inhibitor with prokinetic effects on gastric motility used to treat functional dyspepsia. Patients were treated for 8 weeks.
15775802|NCT04647955|Drug|Placebo|Patients were treated for 8 weeks.
15775803|NCT04647929|Device|Santen PRESERFLO MicroShunt|the PRESERFLO MicroShunt will be implanted to increase aqueous humor outflow
15775804|NCT04647929|Procedure|Trabeculectomy|a fornix-based trabeculectomy with a 3x4mm flap will be performed to increase aqueous humor outflow
15775805|NCT04647916|Biological|Sacituzumab Govitecan|Given IV
15775809|NCT04647890|Drug|FT011|Two x 100mg capsules once daily for 12 weeks
15775810|NCT04647890|Drug|FT011|Two x 200mg capsules once daily for 12 weeks
15775817|NCT04647825|Other|Collection of data from non-invasive epilepsy monitoring|Creation of a large long-term EEG database for seizure detection/prediction
15775818|NCT04647812|Behavioral|Technology-assisted rehabilitation|Augmented exercise therapy with novel technology and home-based telerehabilitation
15775819|NCT04647812|Behavioral|Conventional rehabilitation|Traditional multidisciplinary in-patient rehabilitation
15775820|NCT04647799|Device|smartphone|Samsung A 71
15775821|NCT04647786|Device|Prototype medical device (SEA CtV)|A prototype device that delivers a controlled flow of gas to the upper airways via the subglottic suction port of an established tracheostomy tube. Gas flow may be timed, warmed and/or humidified.
15775822|NCT04647773|Drug|HSK16149 20mg BID|HSK16149 20mg, orally twice a day, treatment period; 13-weeks fixed dose.
15775823|NCT04647773|Drug|HSK16149 40mg BID|HSK16149 40mg, orally twice a day, treatment period; 13-weeks fixed dose.
15775824|NCT04647773|Drug|HSK16149 60mg BID|HSK16149 60mg, orally twice a day, treatment period; 1-week titration and 12-weeks fixed dose.
15775825|NCT04647773|Drug|HSK16149 80mg BID|HSK16149 80mg, orally twice a day, treatment period; 1-week titration and 12-weeks fixed dose.
15775826|NCT04647773|Drug|Pregabalin 150mg BID|Pregabalin 150mg, orally twice a day, treatment period; 1-week titration and 12-weeks fixed dose.
15775827|NCT04647773|Drug|Placebo BID|Placebo, orally twice a day, treatment period; 13-weeks fixed dose.
15775829|NCT04647747|Other|Self measurement with pulse oximeter|Participant will measure peripheral saturation at home, conduct physiotherapy if desaturation occurs, and contact hospital if desatuation persists
15775830|NCT04647734|Behavioral|High intensity interval training|12 weeks of high intensity interval training on exercise bike for 38 minutes 3 times a week
15775831|NCT04647734|Behavioral|Standard care|standard care after discharge from hospital (control group)
15775834|NCT04647708|Drug|M5049|Participants will receive low oral dose of M5049, twice daily in Part A.
15775835|NCT04647708|Drug|M5049|Participants will receive ascending oral dose of M5049, twice daily in Part A.
15775836|NCT04647708|Drug|M5049|Participants will receive high oral dose of M5049, twice daily in Part B.
15775837|NCT04647708|Drug|Placebo|Participants will receive placebo matched to M5049.
15775838|NCT04647695|Drug|Interferon beta-1b|a 5-day course of subcutaneous injection of interferon β-1b 2mL (16 million IU) consecutively and IV remdesivir 200mg loading on day 1 followed by remdesivir 100mg daily on day 2 to day 5
15775839|NCT04647695|Drug|Remdesivir|a 5-day course of IV remdesivir 200mg loading on day 1 followed by remdesivir 100mg daily on day 2 to day 5
15775840|NCT04647682|Other|physical activity program|"30 second chair test,
~balance with joint-feet and semi-tandem stance
~4 meters comfortable walking test were evaluated"
15775841|NCT04647669|Drug|Remdesivir|200 mg intravenous loading dose on Day 1, and 100mg intravenous once-daily for subsequent doses from Day 2 up to Day 10.
15775842|NCT04647669|Drug|Acalabrutinib|100 mg capsules twice daily every 12 h for 10 days taken with or without food.
15775843|NCT04647669|Drug|Interferon beta-1a|Interferon ß-1a will be administered intravenously at the dose of 10 μg once daily for 6 days if oxygen dependent or subcutaneously at 44 ug Day 1, Day 3, and Day 6
15775844|NCT04647669|Other|Standard of Care|Treatment according to local hospital protocol
15775845|NCT04647656|Device|Hyperbaric oxygen|Each session will include exposure of 90 minutes to 100% at 2 ATA, with 5 minutes air breaks every 20 minutes
15775846|NCT04647656|Device|Sham|Each session will include exposure of 90 minutes to 21% at 1.2 ATA during the first five minutes of the session with the noise of circulating air, and then decrease slowly during the next five minutes to 1.03 ATA
15775847|NCT04647643|Drug|Paclitaxel|Paclitaxel to treat peripheral arterial disease
15775848|NCT04647630|Diagnostic Test|urine test|test for pneumococcal antigen in urine
15775849|NCT04647617|Behavioral|Quantitative weight -bearing and report exercise sign data every weekly|keep their normal live style
15775850|NCT04647604|Drug|Omegaven®|A highly refined fish oil in an emulsion for infusion with purified egg phosphatides and glycerol.
15775851|NCT04647604|Drug|Sodium chloride|intravenously administered 2 mL/kg/day
15775852|NCT04647591|Other|Questionnaires|Use of a questionnaire focused on diver experience and medical history upon inclusion and another questionnaire in case of ENT Barautrauma over a period of two years to standardize Barotrauma assessment.
15775853|NCT04647578|Device|GT3X Actigraph accelerometer.|GT3X Actigraph accelerometer during 7 days
15775855|NCT04647552|Drug|Drug Steroid|hydrocortisone injection
15775856|NCT04647526|Drug|[Lu-177]-PNT2002|Participants randomized to Arm A will receive 6.8 GBq (±10%) of [Lu-177]-PNT2002 every 8 weeks for 4 cycles
15775857|NCT04647526|Drug|Abiraterone|Abiraterone (1000 mg orally qd with: 5 mg bid prednisone or 0.5 mg qd dexamethasone)
15775858|NCT04647526|Drug|Enzalutamide|Enzalutamide (160 mg orally qd)
15775884|NCT04647279|Diagnostic Test|Dual-emission X-ray Absorptiometry|The recruiters were divided into osteoporosis, osteopenia and normal by dual emission X-ray absorptiometry.
15775885|NCT04647266|Procedure|endoscopic submucosal dissection|endoscopic submucosal dissection
15775886|NCT04647253|Device|AGENT DCB|Drug coated PTCA balloon catheter
15775887|NCT04647253|Device|PTCA balloon catheter|PTCA balloon catheter
15775859|NCT04647513|Device|Intradermal injection (superficial dermis for Art Filler Fine Lines / moderately deep to deep dermis for Art Filler Universal and Art Filler Lips)|The function of injectable fillers for the treatment of dermal contour deformities is to smooth dermal depressions formed by the loss of volume and the aging process. These fillers (also known as soft tissue augmentation medical devices) can correct the skin depressions/wrinkles, balance the disproportions or correct topographical anomalies.
15775860|NCT04647500|Drug|Concerta|Evaluation of a treatment of Concerta over a period of 13 days.
15775862|NCT04647461|Drug|Brimonidine Tartrate 1.5mg|1 drop 3 times a day for 12 weeks to target eyes
15775863|NCT04647461|Drug|Brimonidine Tartrate 1.5mg|1 drop 3 times a day for 12 weeks to target eyes
15775864|NCT04647448|Diagnostic Test|Application of sensor patch|Application of sensor patch to chest to record acoustic signals due to disturbed blood flow.
15775865|NCT04647435|Drug|APSCTC|APSCTC + Toragesic® placebo + Tramal® placebo
15775866|NCT04647435|Drug|Toragesic®|APSCTC placebo + Toragesic® + Tramal® placebo
15775867|NCT04647435|Drug|Tramal®|APSCTC placebo + Toragesic® placebo + Tramal®
15775868|NCT04647422|Behavioral|Analysis of executive functioning and of social cognition processes|"Investigation of executive and social cognition processes using a comprehensive, neuropsychological assessment, An Eye tracking investigation and Task-based MRI exams.
~Evaluation of addictive, psychiatric and neurological comorbidities.
~Neuropsychological assessment establishing the participants' cognitive profiles of executive functions and of social cognition
~An Eye tracking investigation aiming at a better understanding of participants' emotional processing
~Task-based MRI exams identifying participants' neuroanatomical and neurofunctional correlates of executive functions and of social cognition processes"
15775869|NCT04647409|Other|screening|The determination of the prevalence of NAFLD in a general population in Flanders, Belgium
15775870|NCT04647396|Other|"Comprehensive Implementation of the Bundle recommended by the Kidney Disease: Improving Global Outcomes Group (KDIGO bundle)"|"Implementation of the KDIGO bundle for at least 12 hours
~discontinuation of all nephrotoxic drugs when possible
~optimization of volume status and hemodynamic parameters (consideration of a functional hemodynamic monitoring)
~close monitoring of serum creatinine, fluid balance and urinary output
~avoidance of hyperglycemia
~considerations of alternatives to radiocontrast agents
~discontinuation of angiotensin converting enzyme inhibitors and angiotensin receptor blockers in the perioperative period
~avoidance of HES, gelatin, and chlorid-rich solutions"
15775871|NCT04647383|Drug|Placebo|OSA: Lemborexant-matched oral placebo will be administered at bedtime in the clinic (within 5 minutes before lights off) or at home when not in the clinic.
15775872|NCT04647383|Drug|Lemborexant 10 mg|OSA: 10 mg oral lemborexant will be administered at bedtime in the clinic (within 5 minutes before lights off) or at home when not in the clinic.
15775873|NCT04647383|Drug|Placebo|COPD: Lemborexant-matched oral placebo will be administered at bedtime in the clinic (within 5 minutes before lights off) or at home when not in the clinic.
15775874|NCT04647383|Drug|Lemborexant 10 mg|COPD: 10 mg oral lemborexant will be administered at bedtime in the clinic (within 5 minutes before lights off) or at home when not in the clinic.
15775875|NCT04647370|Procedure|remote ischemic preconditioning|3 cycles of 5-minutes inflation of a blood pressure cuff to 200mmHg (or at least to a pressure 50mm Hg higher than the systolic arterial pressure) to one upper arm, followed by5-minutes reperfusion with the cuff deflated
15775876|NCT04647370|Procedure|Sham remote ischemic preconditioning|3cycles of upper limb pseudo ischemia (low pressure, 5-minutes blood pressure cuff inflation to a pressure of 20 mm Hg and 5-minutes cuff deflation).
15775877|NCT04647357|Drug|SHR-1316|Anti-PD-L1 antibody，Maintenance therapy, The drug was administered every three weeks
15775878|NCT04647344|Drug|AK104 plus Carboplatin and Pemetrexed|Subjects receive AK104 15mg/kg intravenously (IV) plus pemetrexed 500 mg/m^2 IV and carboplatin area under the curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK104 15mg/kg IV plus pemetrexed 500 mg/m^2 IV Q3W until progression.
15775879|NCT04647344|Drug|AK104 plus Carboplatin and paclitaxel|Subjects receive AK104 15mg/kg intravenously (IV) plus paclitaxel 175 mg/m^2 IV and carboplatin area under the curve (AUC) 5 IV on Day 1 of every 3-week cycle (Q3W) for 4 cycles followed by AK104 15mg/kg IV IV Q3W until progression.
15775880|NCT04647318|Behavioral|Compassion focused imagery, relaxation imagery and control task|Participants will engage in three tasks (control task, relaxation imagery, and CFI) every three days on a total of 3-4 occasions. Audio-recordings of scripts will be used for both relaxation and compassion imagery. The 4-minute relaxation imagery will involve the following components (i) breathing deeply and bringing mindful awareness to the breath, (ii) relaxing the body, (iii) multisensory mental imagery of a beach or a forest, (iv) noticing feelings that arise. The 4-minute self-compassion imagery scripts will involve the following components: (i) informing participants that showing ourselves self-compassion is an effective emotional-regulation tool, (ii) breathing deeply and attending mindfully to the breath, (iii) imagining oneself embodying the four characteristics of compassion according to Gilbert5, (iv) imagine wishing oneself free of suffering using a warm voice tone and (v) noticing feelings that arise. The control task will involve reading a local city culture magazine.
15775881|NCT04647305|Other|Closed face shield with Surgical face mask use|Use of a closed face shield with a surgical face mask during daily activities. The educational intervention will provide recommendations on COVID-19 prevention and proper use of the closed face shield and the surgical face masks.
15775882|NCT04647305|Other|Surgical face mask use only|Use of a surgical face mask during daily activities. The educational intervention will provide recommendations on COVID-19 prevention and the proper use of surgical face masks.
15775883|NCT04647292|Drug|anti-hypertensive|"The recommended target SBP will be 115-125 mmHg in the intervention arm. A medication algorithm based on the SPRINT trial protocol will be provided. The final choice and dose of antihypertensive treatment(s) will be at the discretion of the treating clinicians. If no contra-indications, indapamide or other thiazide diuretic and/or angiotensin-converting enzyme (ACE) inhibitor (perindopril or other) will be encouraged as initial therapy, with long-acting calcium-channel antagonists (eg.amlodipine) encouraged as third-line therapy.
~At scheduled face-to-face or remote follow-up, patients will have their home blood pressure monitoring diary reviewed by the study team. If SBP is out of the allocated target range, a prescription to titrate (up or down) antihypertensive medication will be given to the patient."
15775888|NCT04647240|Biological|Dermacyte® Liquid (human amniotic fluid)|Subcutaneous injection into and/or around wound bed weekly
15775889|NCT04647227|Drug|coagulation factor VIIa [recombinant]-jncw|a transgenically produced, activated, recombinant, human factor VII (rhFVIIa) protein with the brand name of SEVENFACT®. This protein is a clotting factor in the coagulation cascade that is produced in and purified from the milk of transgenic rabbits. SEVENFACT is approved for the treatment and control of bleeding episodes occurring in adults and adolescents (12 years of age and older) with hemophilia A or B with inhibitors.
15775890|NCT04647214|Drug|Bimatoprost intracameral implant (DURYSTA) 10μg|Bimatoprost intracameral implant 10μg is administered into the anterior chamber via the corneal limbus using a prefilled applicator
15775891|NCT04647188|Other|Robotic assisted surgery with IDR data capture|Robotic assisted surgery with digital point of care data capture using Intuitive Data Recorder (IDR) technology
15775892|NCT04647175|Other|Fermented aronia|Given twice daily for 8 weeks
15775893|NCT04647175|Other|Aronia|Given twice daily for 8 weeks
15775894|NCT04647175|Other|Placebo|Given twice daily for 8 weeks
15775895|NCT04647162|Procedure|surgical hematoma evacuation|Intervention methods are mainly the evacuation of hematoma under craniotomy or by stereotactic puncture or neuroendoscopy.
15775896|NCT04647162|Other|medical treatment|Patients receive only medical treatment including active life support, nutritional support, homeostasis maintenance of the internal environment, and other symptomatic treatment.
15775897|NCT04647149|Behavioral|Dietary Approach|Dietary approaches with energy restriction performed at different times of the day.
15775898|NCT04647136|Diagnostic Test|Fertility Health Screening|Basic fertility health screening comprising an anti-Mullerian hormone (AMH) test and semen analysis, a doctor's consultation to explain the results, and standardised reproductive counselling by a trained nurse comprising a discussion of reproductive plans (including addressing barriers the couple face), education on age-related fertility decline and limitations of artificial reproductive technologies, advice on the optimal reproductive timing and when to seek further help. An educational brochure will be handed to the couple during the counselling session.
15775899|NCT04647136|Behavioral|Fertility Awareness Tools|Online intervention consisting of 1) video targeting fertility education and specific attitudes, social norms and perceived control for having children, 2) a fertility awareness tool (FERTISTAT) and 3) an educational brochure on fertility. This intervention can be self-administered and is therefore easily scalable.
15775900|NCT04647123|Other|No intervention was applied to the groups the samples will be collected in terms of the diagnosis (hopeless, periodontitis, gingivitis, healthy)|No intervention was applied to the groups the samples will be collected in terms of the diagnosis (hopeless, periodontitis, gingivitis, healthy)
15775901|NCT04647110|Drug|crizotinib|as provided in real world practice
15775902|NCT04647110|Drug|alectinib|as provided in real world practice
15775903|NCT04647110|Drug|brigatinib|as provided in real world practice
15775904|NCT04647110|Drug|ceritinib|as provided in real world practice
15775905|NCT04647110|Drug|lorlatinib|as provided in real world practice
15775906|NCT04647097|Behavioral|Standard intervention only|Standard intervention (SI) will be a part of standard care in all participating centers, and will be provided for all acute pancreatitis patients, who are hospitalized and their condition is alcohol induced. A specially trained study nurse will deliver the intervention, since they were found to be the most effective regarding the decrease in alcohol consumption and smoking. The cost- effectiveness of the intervention and the feasibility were also taken into account. The Assist-linked brief intervention according to the World Health Organization (WHO) will serve as the base for the intervention, with an avarage of 30 minutes, based on a review containing 69 randomized controlled trials, which concluded that longer intervention do not have additional benefit. The patients will be also educated about the disease course of acute pancreatitis during the standard intervention.
15775907|NCT04647097|Behavioral|Standard intervention plus repeated intervention|Standard intervention (SI) will be performed as described above. The repeated intervention will be delivered by the former mentioned same nurse and will be structured similarly to the standard intervention. Every visit and intervention will be individually altered according to the motivation of the patient, but they will follow the same structure. The sessions can be divided into three main parts: first, highlighting the harmful effects of smoking and alcohol on the pancreatic functions. Secondly, a discussion about the motivation of the patient will happen. The last portion of the session will focus on the responsibility of the individual to reach the desired goal will be highlighted. To enhance the efficacy of our intervention we wish to provide feed-back for the patient based on laboratory testing: the mean corpuscular volume (MCV) and gamma glutamyl-transferase (GGT) values will be measured right before the interview. The study nurse will not take part in patient care.
15775908|NCT04647084|Drug|Lidocaine 2% Injectable Solution|An elastic band will be placed around the subject's arm, and the elastic band will be removed once the IV is inserted. After the elastic band is placed on the subject's arm, the arm will be cleaned, and then a small skin wheel will be created with the lidocaine that will be injected very close to where the IV will be placed. The IV will be placed within about a minute from the time when the lidocaine was injected.
15775909|NCT04647084|Device|Buzzy|The Buzzy vibrating ice pack will be placed on the subject's arm with an elastic band around it, and it will remain there as the arm is cleaned and prepped and the IV inserted. The Buzzy device will be removed once the IV is inserted.
15775910|NCT04647071|Dietary Supplement|Garlic and onion concentrate|Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion).
15775911|NCT04647071|Dietary Supplement|Control|Microcrystalline cellulose
15775912|NCT04647058|Procedure|Cubital tunnel release|The control group will undergo cubital tunnel release in situ. In cases of preoperative or intraoperative ulnar nerve instability, anterior transposition of the ulnar nerve will be performed.
15775913|NCT04647058|Procedure|Supercharged end-to-side (SETS) nerve transfer|The SETS group will undergo the same procedure as described above, with the addition of the SETS procedure consisting of a end-to-side transfer of the anterior interosseous nerve to the ulnar nerve motor branch. Decompression of Guyon's canal during the SETS procedure is at the discretion of the treating surgeon.
15775954|NCT04646746|Dietary Supplement|50% gene-modified high-amylose barley and 50% wheat|100 g of bread backed with 50% gene-modified high-amylose barley and 50% wheat
15775914|NCT04647045|Dietary Supplement|Cultured milk drink|Each bottle contains 109 cfu Lactobacillus acidophilus LA-5 and Lactobacillus paracasei L. CASEI-01. In each 100 ml unit, it contains 4.06 g of fructose, 4.14 g of glucose, 0.29 g of sucrose, less than 0.1 g of maltose and 1.35 g of lactose.
15775915|NCT04647032|Device|Transcranial alternating current stimulation|Transcranial alternating current stimulation (tACS) will be applied across the prefrontal cortex near electrodes coordinates AF3/AF4
15775916|NCT04647019|Dietary Supplement|Wild blueberry powder|22 g freeze-dried wild blueberry (Vaccinium angustifolium) powder consumed daily with 250 ml water. The powder is sealed in sachets and stored at -24 °C, except when transported. Participants are asked to store the sachets in a freezer until consumption.
15775917|NCT04647019|Dietary Supplement|Placebo powder|22 g placebo powder matched for macronutrients, color, and flavor consumed daily with 250 ml water. The powder is sealed in sachets and participants are asked to store the sachets in a freezer until consumption.
15775918|NCT04647006|Procedure|thyroid|Conventional Thyroidectomy and Transoral endoscopic thyroidectomy vestibular approach
15775919|NCT04646980|Dietary Supplement|Biobran/MGN-3|Biobran/MGN3 is defined by the Medicines and Healthcare products Regulatory Agency (MHRA) as a food supplement. Biobran/MGN3 is manufactured by hydrolyzing rice bran with the enzymatic extract of medicinal Shiitake mushrooms. Enzyme hydrolysis of rice bran produces arabinoxylane, a hemi-cellulose compound, which constitutes the active ingredient of biobran/MGN3.
15775920|NCT04646980|Other|Placebo|Placebo, with same appearance and taste as Biobran/MGN-3, was given to control subjects at a dose of 500 mg everyday for 3 months
15775921|NCT04646967|Drug|Bupivacain|See active comparator description
15775922|NCT04646967|Drug|Sevoflurane|See active comparator description
15775923|NCT04646967|Drug|Acetaminophen|See active comparator description
15775924|NCT04646967|Drug|Ibuprofen|See active comparator description
15775925|NCT04646967|Drug|Ketorolac|See experimental arm description
15775926|NCT04646954|Diagnostic Test|Host DNA methylation testing|Host EPB41L3, JAM3 and PAX1 methylation testing by cytology sample
15775927|NCT04646954|Diagnostic Test|Cervical cytology and/or high-risk human papillomavirus assays|Cervical cytology and/or high-risk human papillomavirus assays
15775928|NCT04646941|Other|regular treatment|The patients with or without OSA received regular hypoglycemic drugs.
15775929|NCT04646915|Other|Day surgery|Patients with CuRC who meet the standards will be assigned to day surgery center for surgery
15775930|NCT04646889|Drug|AR882 Single Dose|A single dose of AR882
15775931|NCT04646889|Drug|AR882 Multiple Dose|AR882 taken once daily for 14 days
15775932|NCT04646876|Drug|Magnesium Sulfate|Prospective , comparative , double blind study
15775933|NCT04646876|Drug|Placebo|Prospective , comparative , double blind study
15775934|NCT04646863|Radiation|laser therapy|performed by MLS® Laser Therapy (ASA Srl, Vicenza, Italy). It is designed to synchronize between two modules. One is emitting at 905 nm, with peak optical power = 25 W; each pulse is composed of a pulse train (single pulse width = 100 ns, maximum frequency 90 kHz). The frequency of the pulse trains varied between 1 and 2000 Hz. The other one is emitting at 808 nm in a continuous mode (power 1.1 W) or pulsed mode (pulses repetition rate 1-2000 Hz).
15775935|NCT04646863|Other|exercise|"The exercises were applied on a floor mat to achieve a full body workout with 10 repetitions for each exercise and rest for one minute before beginning the next exercise to avoid muscle fatigue as the following.
~Modified Hundred
~Modified Single Leg Stretch
~One Leg Circle
~Modified Scissors"
15775936|NCT04646863|Other|combination|laser therapy + Pilates exercises
15775937|NCT04646850|Other|Color duplex ultrasound of the carotid arteries|Examinations carried out according to the American Society of Echocardiography guidelines 25 using a Vivid 7 US instrumentation with a linear M12L probe (14 MHZ; General Electric).
15775938|NCT04646837|Drug|Durvalumab|Durvalumab 1000 mg IV Q3W for 2 cycle + Followed by adjuvant treatment for 1 year with Durvalumab 1000 mg IV Q3W for 4 months and Durvalumab 1500mg Q4W for 8 months
15775939|NCT04646837|Drug|Albumin Paclitaxel|Albumin Paclitaxel 200-260 mg, depending on the patient's physical condition, for 2 cycle
15775940|NCT04646837|Drug|Carboplatin/Cisplatin|Carboplatin AUC 6 IV Q3W or Cisplatin 80mg/㎡ for 2 cycle
15775941|NCT04646824|Drug|Almonertinib Pemetrexed/Cisplatin|Pemetrexed/Cisplatin Drug: Pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by Almonertinib daily with pemetrexed maintenance (500 mg/m2) every 3 weeks.
15775942|NCT04646811|Procedure|Tricuspid valve|Clip for the tricuspid valve implantation on top of best medical therapy
15775943|NCT04646811|Other|Best medical treatment|Best medical therapy alone
15775944|NCT04646798|Other|Hemiarthroplasty|standard surgical approaches to repair of fractured elbows
15775945|NCT04646798|Other|Total elbow arthroplasty|standard surgical approaches to repair of fractured elbows
15775946|NCT04646785|Behavioral|Mindfulness-based cognitive therapy + TAU|The proposed intervention is mindfulness-based cognitive therapy (MBCT), based on the protocol published by Segal, Williams and Teasdale. MBCT consists of eight weekly 2.5h group sessions, a six-hour silent day and daily home practice assignments guided by audio files. The program includes both formal and informal meditation exercises. Cognitive techniques include monitoring and scheduling of activities, identification of negative automatic thoughts and devising a relapse prevention plan. Psycho-education and interactive dialogue typically focus on stress management, balancing activities, and (lifestyle) strategies to stay well in the future (relapse prevention).
15775947|NCT04646785|Other|Treatment as usual (TAU)|Treatment as usual (TAU) according Dutch and European IBD treatment guidelines. TAU focuses on pharmacological and surgical disease control, and prevention of complications.
15775948|NCT04646772|Procedure|Multivisceral resection|Multivisceral resection for locally advanced colon cancer.
15775949|NCT04646759|Drug|Fulvestrant combined with Pyrotinib|Fulvestrant 500mg was injected intramuscularly on D1, D15, D28 and D28 Pyrotinib 400mg daily
15775950|NCT04646759|Drug|Capecitabine combined with Pyrotinib|Capecitabine 1000mg/m^2 bid d1-d14，every 21 days Pyrotinib 400mg daily
15775951|NCT04646746|Dietary Supplement|100% wheat|100 g of bread backed with 100% wheat
15775952|NCT04646746|Dietary Supplement|50% nude barley and 50% wheat|100 g of bread backed with 50% nude barley and 50% wheat
15775953|NCT04646746|Dietary Supplement|75% nude barley and 25% wheat|100 g of bread backed with 75% of nude barley and 25% wheat
15775955|NCT04646733|Other|High Protein Diet Group|The high protein diet (HPD) group is instructed to follow a low carbohydrate, high protein ketogenic diet. This diet has 4 phases, two of weight loss until reaching the ideal weight (attack and cruise) and two of maintenance (consolidation and stabilization). During the first 2 phases, it allows 100 foods (28 vegetables). The first phase lasts 3-10 days and 72 high-protein, low-fat foods are allowed. In the second phase, there are alternate days between consuming the low glycemic index vegetables plus protein and the next day with just protein. The first two phases are ad libitum. Phase 3 (consolidation) aims to avoid rebound and begins the introduction of complex carbohydrates and legumes in individual servings. In phase 4 (stabilization), the subject returns to a free diet. However, three basic rules are introduced: protein one day a week, the exercise of at least 20 min/day (optional) and consumption of 3 tablespoons of oat bran/day.
15775956|NCT04646733|Other|No High Protein Diet Group|No high protein diet (NHPD) group received an oat beverage consisted of 55 g of oats in 250 ml of water. Beverage contained 1.6 g of betaG per portion according to FDA recommendations corresponding to 50 % of betaG required per day. Weekly bags containing oat mixture were provided on day 0 and in the third week of the trial. No additional instructions about diet, exercise program or pharmacological treatment was implemented.
15775957|NCT04646707|Drug|Erector Spinae (ESP) Block with Lidocaine/Bupivacaine|Bilateral ESP block at T1 level with 20 ml of 1:1 mixture (2% Lidocaine: 0.5% bupivacaine)
15775958|NCT04646707|Drug|Erector Spinae (ESP) Block with placebo|Bilateral ESP block at T1 level with 20 ml of 0.9% normal saline
15775959|NCT04646694|Drug|Ketamine|The use of oral Ketamine in this study is experimental.This study will look at how effective and safe Ketamine.
15775960|NCT04646694|Other|Placebo|A placebo is given in this study to reduce the chances of believing that pain after surgery is getting better because one is receiving oral Ketamine
15775961|NCT04646681|Behavioral|ConnectCare|increased monitoring between clinical mental health visits
15775962|NCT04646668|Combination Product|E-cigarette and Heat not burn|Current smokers will be randomized to session order and complete a standardized 10-puff bout (5 minutes) followed by a 60-minute ad libitum session with each product (usual brand cigarette, e-cigarette, heat-not-burn).
15775963|NCT04646655|Drug|Enoxaparin|subcutaneous injections
15775964|NCT04646629|Device|electroacupuncture treatment|"Participants in the treatment group underwent 60 minutes acupuncture (0.30mm×70mm) at ST36 (Zusanli) and ST37 (Shangjuxu) twice a day for seven days.After Deqi, electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) is connected with the density wave (2/100 Hz), width 0.25 ms, intensity of 1 ~ 30 mA (gradually increase to the patient's maximum tolerance) and maintained the end of treatment."
15775965|NCT04646629|Device|sham electroacupuncture treatment|"Participants in the sham electroacupuncture group received shallow needling (0.30mm×25mm) at ST36 and ST37(nonacupoints located 1 inch beside acupoints, about20mm). Specifically, the depth of needle insertion into nonacupoints is 3-5mm and avoided manual stimulation and no Deqi without actual current output, and retained the needle for the same time as treatment group"
15775966|NCT04646616|Other|Community popular opinion leader (POL) based intervention|A community popular opinion leader (POL) based intervention to promote measures to reduce COVID-19 risk, transmission, access to testing and treatment, reduction of the impact of COVID-19, and addressing the Substance Abuse, Violence, HIV/AIDS, and MEntal health (SAVAME) syndemic in the community. POLs will interact within their networks counseling regarding COVID-19 and SAVAME factors. The POLs will refer individuals to appropriate community services. POLs will record basic sociodemographic characteristics of all community contacts, the issue addressed, and their response to it. The first 300 community contacts will be invited to complete a baseline and 3-month follow up surveys (via internet or phone). The content of the surveys includes: 1) COVID-19 related questions (knowledge, impact, symptoms, risk factors, access to testing and care, acceptability contact tracing, vaccine) 2) Biological risk factors, 3) Social determinants of health, 4) SAVAME outcomes and access to services.
15775967|NCT04646603|Drug|MRG-001|Subjects will receive subcutaneous MRG-001 injections.
15775968|NCT04646603|Drug|Placebo|Subjects will receive subcutaneous placebo injections.
15775969|NCT04646590|Biological|Recombinant new coronavirus vaccine (CHO cell) group|Intramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
15775970|NCT04646590|Biological|Recombinant new coronavirus vaccine (CHO cells) placebo group|Intramuscular injection of deltoid muscle of upper arm of 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells) placebo.
15775971|NCT04646577|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|Subjects will either undergo (1) active low-frequency rTMS (1Hz continuous) prime with anodal Transcranial Direct Current Stimulation (tDCS) on the affected side combine with Constraint induced movement therapy. Each session will last 20 minutes.
15775972|NCT04646577|Device|Transcranial Direct Current Stimulation (tDCS|Subjects will either undergo sham Transcranial Direct Current Stimulation (tDCS) on the affected side combine with Constraint-induced movement therapy.
15775973|NCT04646564|Drug|standard of care|patients receive appropriate therapy at the discretion of the treating oncologist, i.e. systemic therapy according to molecular subtypes, including chemotherapy, endocrine therapy, targeted therapy, or immunotherapy.
15775974|NCT04646564|Radiation|radiotherapy + standard of care|"Patients receive radiotherapy to all known metastases. SBRT technique is preferred, especially for metastases in bone, lung and liver. Conventional RT can be used when SBRT is not appropriate, such as metastasis in mediastinal or contralateral supraclavicular nodal regions. Total doses of 30Gy to 50Gy in 5 fractions for SBRT are recommended depending on the tolerance of adjacent normal tissue. Total dose of 60Gy in 25 fractions is recommended for conventional RT.
~Patients can receive systemic therapy concurrently with RT at the discretion of treating radiation oncologist. After completion of SBRT to all sites of known metastatic disease, patients will continue standard of care therapy per the treating oncologist."
15775975|NCT04646538|Other|Regenerative Endodontics Procedures (REPs)|REPs was done for 10 mature maxillary necrotic teeth with periapical lesions. Instrumentation was done using Protaper Next system till size X3. Irrigation with 1.5 % NaOCl was done in the first visit. in the second visit, bleeding was induced in the canal by irritating the periapical area followed by the application of Biodentine as cervical plug then completion of the coronal restoration.
15775976|NCT04646525|Diagnostic Test|Physical examination|Pediatric patients diagnosed with COVID-19 and who have had infection will be examined, adenoid and tonsillar tissues will be evaluated in terms of hypertrophy, chronic, or recurrent infection.
15775977|NCT04646512|Dietary Supplement|Taurine group and exercise and placebo group and exercise|Both groups supplemented with taurine and / or placebo will perform physical training.
15775978|NCT04646512|Other|Physical training with Deep Water Running|There will be a physical training for eight weeks.
15775979|NCT04646499|Device|Transcranial alternating current stimulation|Transcranial alternating current stimulation (tACS) will be applied at 40 Hz (gamma band) during eight sessions over the course of a month.
15775980|NCT04646486|Behavioral|Video debriefing|Obstetric teams will review their own performance on video in a debriefing session to improve future performance.
15775981|NCT04646473|Behavioral|SweetGoals app|App offers goal setting and feedback
15775982|NCT04646473|Behavioral|Coaching|Web health coaching
15775983|NCT04646473|Behavioral|Incentives|Financial incentives for meeting goals
15775984|NCT04646460|Behavioral|Observed Success|"The demonstrator in video gets a placebo treatment, Levoderm analgesic cream, which will be shown to be effective at relieving pain."
15775985|NCT04646460|Behavioral|Observed Failure|The demonstrator in the video gets the same placebo treatment, but shows little to no effectiveness from the placebo for relieving pain.
15775986|NCT04646460|Behavioral|Experienced Success|The participant will receive reduced stimulus intensities after the placebo cream treatment to reinforce the effectiveness of the cream.
15775987|NCT04646460|Behavioral|Experienced Failure|The participant will not receive reduced stimulus intensities after the placebo treatment, so the cream is not reinforced as effective.
15775988|NCT04646447|Dietary Supplement|L-serine|"L-Serine Arm L-serine is considered as GRAS (generally recognized as safe) by the FDA and has been approved as a normal food additive under CFR172.320.
~All patients will receive the same L-serine dose treatment over 12 months. Arm: Experimental: L-Serine 250 mg / kg / day during the first two weeks. From week 3 to 52, 500 mg / kg / day. L-serine orally administered, divided into three doses a day.
~The L-Serine will be manufactured, packaged, labeled and/or distributed by NUTRICIA or delegated contractors. It will be presented in a powdered form of 100 gr of the amino acid L-serine. For oral use.
~Sufficient L-serine will be dispensed at home considering the dose according the weight of the patient."
15775989|NCT04646434|Procedure|Electroencephalography|Undergo EEG
15775990|NCT04646434|Procedure|Electromyography|Undergo EMG
15775991|NCT04646434|Other|Questionnaire Administration|Complete questionnaire
15775992|NCT04646421|Behavioral|Motivational telephone intervention|Motivational telephone intervention to high-risk gamblers, aiming to stimulate them to reduce gambling, quit gambling, or to seek peer support or treatment.
15775995|NCT04646382|Dietary Supplement|Garlic and onion concentrate|Garlic extract concentrate (equivalent to 2 garlic cloves) and onion extract concentrate (equivalent to 1 onion).
15775996|NCT04646382|Dietary Supplement|Control|Microcrystalline cellulose
15775997|NCT04646369|Behavioral|"screening as usual"|Participants in this group will receive usual care at their pediatric primary care practice following information, psychoeducation, and referral to a mental health treatment provider
15775998|NCT04646369|Behavioral|Screening Wizard 2.0|Screening Wizard is a decision support tool to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment.
15775999|NCT04646369|Behavioral|Screening Wizard 2.0 + SOVA|Screening Wizard is a decision support tool to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment. SOVA is a peer-support website that social workers and doctors moderate on a 24 hour a day basis.
15776000|NCT04646356|Drug|Tacrolimus capsule (low-dose)|low-dose Tacrolimus will be given for 6 months followed by a washout period for 6 months
15776001|NCT04646343|Other|administration of F-CISS and F-PWES pre version|the CISS questionnaire is a 6 items questionnaire, the PWES is a 3 items questionnaire. Only 10 minutes are required to fulfilled the questionnaires.
15776002|NCT04646343|Other|administration of definitive version of F-CISS and F-PWES plus F-DASH, F-HFS and F-SF 36|The administration will required 25 minutes
15776003|NCT04646330|Drug|AK104+anlotinib|AK104+anlotinib
15776004|NCT04646317|Drug|Dexmedetomidine injection|Infusion of dexmedetomidine will be prepared in Four syringes of 50ml containing dexmedetomidine in concentration of 1 microgram per millilitre.
15776005|NCT04646317|Drug|Normal Saline|0.9% as placebo
15776006|NCT04646304|Other|Objective Feedback (Motion Capture)|Participants assigned to the objective feedback group will be given a report after completing Set 1 and Set 2. This report will outline their performance for each significant factor (identified in Phase 1) relative to a target interval, derived from the staff surgeon group average (± one standard deviation). Participants assigned to the objective feedback group will then be able to repeat the tasks knowing which variables to improve.
15776007|NCT04646291|Device|Insemination with the Mosie Baby Kit|The participant will have performed at least one cycle of insemination using the Mosie Baby Kit.
15776008|NCT04646278|Drug|Hyperemic stimuli|Hyperemic simuli of coronary flow by adenosine or nicorandil injection
15776009|NCT04646265|Other|periodontal treatment|non-surgical root debridement
15776010|NCT04646252|Other|Perfused Boundary Region of sublingual microvessels|Measurement of Perfused Boundary Region of sublingual microvessels to assess thickness of endothelial glycocalyx
15776011|NCT04646239|Diagnostic Test|Heterologous stimuli|In vitro exposure of peripheral blood mononuclear cells to heterologous stimuli
15776012|NCT04646239|Diagnostic Test|Neutralization assay|In vitro measurement of neutralizing antibody activity to wild-type SARS-CoV-2
15776015|NCT04646213|Behavioral|Managing Cancer and Living Meaningfully (CALM) Therapy|6 sessions of individualized CALM therapy
15776092|NCT04645563|Other|Sending thorax ct video images via smartphone applications|Video images of the patients will be sent via smartphone application to infectious disease specialist for consulting.
15776016|NCT04646200|Behavioral|Cognitive Behavioral Therapy-Insomnia|CBT-I addresses cognitive, arousal and behavioral factors related to sleep difficulties. Sessions combine assessment, conceptualization, psychoeducation, behavioral strategies and cognitive therapy, using a consistent structure including review of participants' sleep log and adherence to behavioral guidelines, modification of time in bed, cognitive therapy, and relaxation techniques. CBT-I also incorporates psychoeducation about biological and psychological elements that regulate sleep. Other strategies include stimulus control (i.e., getting out of bed when not sleepy) to extinguish the conditioned arousal common in insomnia, and relaxation techniques to reduce arousal associated with the bed, bedroom, or bedtime.
15776017|NCT04646200|Behavioral|Health and Wellness|Health and Wellness is a general self-management curriculum focused on providing education and support for managing physical and emotional well-being. Each session follows a basic structure including review of previous session material, new educational information and discussion on several topics over the course of single or multiple sessions. Each session will focus on the impact of the topic on overall health and wellness, identifying benefits and challenges to improving or maintaining health in that area, and strategies that clients may find helpful to address challenges in that area. Example topics include physical activity/exercise, nutrition/healthy eating, managing medications and side effects, and addictive behaviors (e.g., substance use, gambling, eating).
15776018|NCT04646187|Biological|Infliximab|Dosing interval lengthening from 8 to 12 weeks
15776019|NCT04646187|Biological|Adalimumab|Dosing interval lengthening from 2 to 3 weeks
15776020|NCT04646174|Behavioral|Unified Protocol adapted for smoking cessation|Treatment components are cognitive-behavioral strategies adapted from the Unified Protocol (UP) for the Transdiagnostic Treatment of Emotional Disorders. Behavioral counseling strategies for smoking cessation, drawn from current US Public Health Service guidelines, are incorporated in each treatment module.
15776021|NCT04646174|Behavioral|American Lung Association self-management strategies for smoking cessation|Treatment components are self-management strategies provided through printed self-help materials from the American Lung Association. The materials consist of the Freedom from Smoking guide, Relaxation Exercises for Better Breathing, and COPD; Exercise and Daily Activity guide that address evidence-based smoking cessation and self-management strategies to aid in a quit attempt.
15776022|NCT04646161|Drug|Misoprostol|misoprostol 200 mcg will be given sublingual 2 hrs before mirena iud insertion
15776023|NCT04646148|Behavioral|Yoga classes|All participants are invited to attend weekly yoga classes.
15776024|NCT04646135|Drug|Lorazepam 4 mg/ml|Lorazepam will be administered intravenously according to the scheduled sequences.
15776025|NCT04646122|Device|Optical Coherence Tomography|Optical Coherence Tomography parameters
15776026|NCT04646109|Drug|Ivermectin|"Ivermectin 5mg/5ml solution was manufactured by NEUTEC™ Pharmaceutical Company-Turkey, under Good Manufacturing Practices (GMP) certification conditions."
15776027|NCT04646096|Device|MAKO THA 4.0 System|"Measure how the accuracy and precision of robotic arm-assisted total hip arthroplasty (THA) for placement accuracy of implant position in both the anterior and posterior approach.. The intervention will assess the precision of the MAKO system in placing hip components according to plan. It will compare hip angles executed by the Mako system intraoperatively with the 'gold standard' of 3D computer tomography (CT) scans.
~The postoperative CT scan can show the precision of the MAKO system by accurately determining the location of hip replacements in patients after surgery."
15776028|NCT04646070|Procedure|Reduction mammaplasty|Breast reduction surgery
15776029|NCT04646057|Device|DuraSorb®|Monofilament Surgical Mesh
15776033|NCT04646031|Drug|T89 capsule|T89 capsule, an medicinal product for oral use under active INDs in the US is a botanical drug containing 75mg active substance of the water extract of Danshen and Sanqi.
15776034|NCT04646018|Other|Lumbar Spine Manipulation|Lumbar non-thrust manipulation is a passive movement that is performed with a rhythm and a grade in a manner in which the patient is able to prevent the technique from being performed.
15776035|NCT04646018|Other|Sham Manipulation|Lumbar non-thrust manipulation without force applied
15776036|NCT04646005|Drug|Cemiplimab|Administered intravenously (IV) every three weeks (Q3W)
15776037|NCT04646005|Biological|ISA101b|Administered by subcutaneous (SC) injection on day 1, day 29, and day 50
15776038|NCT04645992|Device|active TENS|study group will receive only one session of yoga eye exercise for 20 minutes followed by TENS by placing electrodes on skin over urinary bladder (BL) acupoints 61 and 62 for 20 minutes
15776039|NCT04645992|Device|sham TENS|control group will be treated with the same protocol as the study group but with the TENS unit is off .
15776040|NCT04645979|Other|Online survey|Participants will be invited to complete an online questionnaire about their experience of product use.
15776041|NCT04645966|Biological|MenABCWY|Neisseria mengitidis groups A, B, C W, and Y vaccine
15776042|NCT04645966|Biological|Bivalent rLP2086 (60-µg Dose)|Trumenba (half dose) - Meningococcal Group B vaccine
15776043|NCT04645966|Biological|Bivalent rLP2086 (120-µg Dose)|Trumenba - Meningococcal Group B vaccine
15776044|NCT04645966|Biological|Bexsero|Bexsero - Meningococcal Group B vaccine
15776045|NCT04645966|Drug|Prophylactic Liquid Paracetamol (PLP)|PLP administration during primary vaccinations 1 and 2
15776046|NCT04645966|Biological|Nimenrix|Nimenrix - Meningococcal Group A, C, W and Y vaccine
15776050|NCT04645940|Drug|fruquintinib with food/fruquintinib without food/fruquintinib with rabeprazole|"fruquintinib 5 mg with food on Day 1 and fruquintinib 5 mg without food on Day 15.
~40 mg rabeprazole from Day 23 to Day 28. 40 mg rabeprazole one hour before 5 mg fruquintinib Day 29."
15776051|NCT04645940|Drug|fruquintinib without food/fruquintinib with food/fruquintinib with rabeprazole|"fruquintinib 5 mg without food on Day 1 and fruquintinib 5 mg with food on Day 15.
~40 mg rabeprazole from Day 23 to Day 28. 40 mg rabeprazole one hour before 5 mg fruquintinib Day 29."
15776052|NCT04645927|Dietary Supplement|flaxseed beverage|"Pizzey Ingredients Inc. introduced a flax beverage product that is a plant-based beverage product that is designed as an alternative to non-diary milks (almond milk & soy milk). Each 330 ml serving of flax beverage contains 15 g flaxseed, which amounts to 3.75 gm of omega-3 fatty acid. Preventing MCI or even AD may be within reach, if appropriate measures are taken early enough using strategies such as dietary supplementation."
15776053|NCT04645927|Dietary Supplement|control beverage|Oat fibre control. For 180 days (6 months) participants will consume 2 servings of 330 ml of placebo beverage (i.e. normal fiber beverage; control) per day.
15776054|NCT04645914|Behavioral|Use of nicotine product (smoking/vaping)|The smokers/vapers are consuming during the study one nicotine product of their own. The dose is the same as each individual is consuming regularly
15776055|NCT04645901|Drug|Drug: SYHA1805 tablets|Oral tablets of SYHA1805 with several doses
15776056|NCT04645901|Drug|Placebo|Oral tablets of placebo with matching several doses
15776057|NCT04645888|Procedure|Impacted tooth surgery|Surgical extraction of İmpacted tooth
15776058|NCT04645875|Other|Sit regimen|See Sit regimen arm description
15776059|NCT04645875|Other|SitLess regimen|See SitLess regimen arm description
15776060|NCT04645862|Diagnostic Test|CT scans|4D CTA imaging
15776061|NCT04645849|Biological|Immunomonitoring|"16 patients will be recruited at the end of treatment: an immunoprofiling analysis will be performed out of a blood sample about 1 month, 5 months and 9 months after treatment.
~8 patients will be recruited at diagnosis: a immune profile analysis will be performed before the start of treatment. This will give comparative values for the immune system cells and molecules."
15776062|NCT04645836|Behavioral|New management mode|"New management mode intervention: Pharmaceutical care
~SMS text messages and Phone Calls
~Behavioural Educational leaflet
~Self-Administered Therapy A financial incentive for mobile use"
15776063|NCT04645823|Drug|Fentanyl Citrate|Fentanyl citrate 20 µg in 2 ml of saline injected into csf
15776064|NCT04645823|Drug|Lidocaine 1% Injectable Solution|Fentanyl citrate 100µg and lidocaine hydrochloride 80 mg in 10 ml volume
15776065|NCT04645823|Drug|Fentanyl Citrate|Fentanyl citrate 100µg and lidocaine hydrochloride 80 mg in 10 ml volume
15776066|NCT04645810|Radiation|High-Dose-Rate Brachytherapy|High-Dose-Rate Brachytherapy Targeting only to AXUMIN PET Visible Lesion
15776067|NCT04645797|Drug|APR003|This portion of the study further explores the clinical activity, safety, pharmacokinetics and pharmacology of APR003 monotherapy at the RP2D and to assess the antitumor activity of APR003 in subjects with unresectable CRC with liver metastases.
15776068|NCT04645784|Other|Supporting Student-Athletes Mental Wellness|The module addresses: 1) managing your own mental wellness; 2) signs and symptoms of mental health problems; 3) role of student-athletes in creating a positive team environment that is supportive of mental health care seeking; 4) the role of a student-athlete in helping teammates; 5) how to identify emergency and non-emergency mental health situations.
15776069|NCT04645771|Procedure|Questionnaires|Questionnaires to assess the quality of life (EQ-5D, CVVQ, CIVIQ, AVVQ, Patient satisfaction survey)
15776070|NCT04645758|Combination Product|Dry needling and Extra corporeal Shock wave therapy|5 mins of dry needling and 1250 pulses of shockwave therapy on dominant forearm muscles
15776071|NCT04645745|Dietary Supplement|myo-inositol, alpha-lactalbumin, folic acid|Evaluating the improvement vs the baseline after three and six months of treatment
15776072|NCT04645732|Behavioral|Personalized exercise therapy and self-management support program|See description under Arms
15776073|NCT04645732|Other|Usual care|See description under Arms
15776074|NCT04645719|Other|Lactate ringer group|General anesthesia only
15776075|NCT04645719|Drug|Magnesium sulfate dose through real weight group|General anesthesia + magnesium sulfate 15 mg.kg-1.h-1 based on the patient's real weight
15776076|NCT04645719|Drug|Magnesium sulfate dose through corrected ideal weight group|General anesthesia + magnesium sulfate 15 mg.kg-1.h-1 based on the patient's corrected ideal weight
15776077|NCT04645706|Other|Characteristics of innate T cells|functional and phenotypic characteristics of innate T cells
15776078|NCT04645680|Other|Dietary Intervention|Consume isocaloric whole foods diet higher in fiber
15776079|NCT04645680|Other|Dietary Intervention|Whole foods diet
15776080|NCT04645680|Other|Quality-of-Life Assessment|Ancillary studies
15776081|NCT04645680|Other|Questionnaire Administration|Ancillary studies
15776082|NCT04645667|Drug|Tacrolimus|Patients will be enrolled into this group if they receive tacrolimus per standard of care. This is an observational study and no interventions will be made.
15776083|NCT04645654|Behavioral|Hypnosis|Three sessions of 30 minute hypnosis, based on standardised script, focused on pain management.
15776084|NCT04645641|Device|Continuous Glucose Monitoring System|Continuous Glucose Monitoring System
15776085|NCT04645628|Other|MRI examination|All subjects (healthy subjects and patients) will have an MRI examination with optimized sequences
15776086|NCT04645615|Device|Cardioblate surgical ablation system|This investigation is a prospective, non-randomized multicenter clinical trial evaluating the outcome of patients with AF requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass grafts (CABG) procedures.
15776087|NCT04645615|Procedure|Surgical RF Ablation|This investigation is a prospective, nonrandomized multicenter clinical trial evaluating the outcome of patients with AF requiring concomitant open heart surgery plus the Cardioblate Surgical Ablation System using the modified Maze III procedure. The trial population includes patients requiring valve replacements or repairs, atrial septal defect (ASD) repairs, patent foramen ovale (PFO) closure or coronary artery bypass grafts (CABG) procedures.
15776088|NCT04645602|Drug|Lenvatinib|Pill taken by mouth, once daily.
15776089|NCT04645602|Drug|Pembrolizumab|Intravenous injection through a vein (IV).
15776090|NCT04645589|Drug|Myfortic|There is no treatment allocation. Patients administered Myfortic by prescription that have started before inclusion of the patient into the study will be enrolled.
15776091|NCT04645576|Device|Face correction with injectable fillers|Injection of hyaluronic acid-based fillers
15776093|NCT04645550|Drug|Apixaban|From postoperative day 3, patients will receive oral Apixaban 2.5mg bid for six months.
15776094|NCT04645550|Drug|Warfarin|From postoperative day 3, patients will receive oral Warfarin 2.5mg qd with titration of dose to maintain a target INR of 2-3 for six months.
15776095|NCT04645550|Drug|Aspirin|From postoperative day 3, patients will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for six months.
15776096|NCT04645550|Drug|Dipyridamole|From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months.
15776097|NCT04645550|Drug|Low molecular weight heparin|From postoperative day 3, patients will receive subcutaneous injection of Low Molecular Weight Heparin (4100 IU) once daily for first five days.
15776098|NCT04645524|Drug|AD182|Oral capsule administered before bed
15776099|NCT04645524|Drug|AD504|Oral capsule administered before bed
15776100|NCT04645524|Drug|Placebo|Oral capsule administered before bed
15776101|NCT04645511|Procedure|Balloon sinuplasty of maxillary sinuses|A shapeable tip of the balloon dilatation device (Entellus XprESS LoProfile; Stryker Corporation, Kalamazoo, Michigan, U.S.A.), with maxillary bending, is inserted into the maxillary sinus ostium. Then guided with the tip, a flexible balloon (6 mm x 20 mm) is gently inserted into the ostium and inflated up to 12 atm for 15 seconds. The dilatation is repeated one more time. The same procedure is performed for both maxillary sinuses.
15776102|NCT04645511|Procedure|Sham surgery|"The middle meatus is gently palpated with a curved suction tip (the tip is not connected to a suction unit). The curved suction tip is placed medial to the uncinate process. In order to create a better placebo effect, the operating doctor says: Now inflate the balloon up to 12 atm for 15 seconds. After 15 seconds the doctor says: Deflate the balloon. This is repeated one more time. Similar procedure is carried out on both sides."
15776103|NCT04645485|Biological|Nebulization of autologous non-hematopoietic peripheral blood stem cells (NHPBSC).|Participants received the investigational therapy through compressor (jet) nebulization, in two doses divided on Days 0 and 1. Each dose contains 10 mL of peripheral blood-derived stem cells CD45-/CD90+/CD133+.
15776104|NCT04645472|Device|CT-Ultrasound|For patients with kidney stones who are planning to undergo PCNL, perform a preoperative simulated CT-ultrasound fusion examination to further clarify the condition of the kidney stones and simulate and optimize the puncture route. Apply CT- Ultrasound fusion precise positioning to guide the intraoperative PCNL puncture process.
15776105|NCT04645459|Other|low phosphorus meals|All subjects followed their usual diets but took one tablet of calcium carbonate as phosphate binder per meal for the first week washout diet. After washout diet, subjects were assign to control or study group randomly and entered to the study period for one week. The diets of the study group were low phosphorus ( LP group), but the dietary phosphorous levels of the control group were not modified. During the study period, all subjects including LP group and control group still kept their usually accustomed behavior about regular breakfast and also took one tablet of calcium carbonate as phosphate binder with every breakfast meal. The LP group and control group replaced daily lunch and dinner with low phosphorus and standard meals respectively and should not take any phosphate binder during the study period for one week.
15776106|NCT04645459|Other|control meals|All subjects followed their usual diets but took one tablet of calcium carbonate as phosphate binder per meal for the first week washout diet. After washout diet, subjects were assign to control or study group randomly and entered to the study period for one week. The diets of the study group were low phosphorus ( LP group), but the dietary phosphorous levels of the control group were not modified. During the study period, all subjects including LP group and control group still kept their usually accustomed behavior about regular breakfast and also took one tablet of calcium carbonate as phosphate binder with every breakfast meal. The LP group and control group replaced daily lunch and dinner with low phosphorus and standard meals respectively and should not take any phosphate binder during the study period for one week.
15776107|NCT04645446|Drug|Pro-ocular gel|Topical gel in multidose formulation to be applied laterally to the forehead twice a day, morning and night for 3 months
15776108|NCT04645446|Drug|Placebo gel|Topical gel in multidose formulation to be applied laterally to the forehead twice a day, morning and night for 3 months
15776109|NCT04645420|Procedure|Global gene expression profiles obtained from synovial biopsies.|Global gene expression profiles obtained from synovial biopsies before and after 24 weeks of treatment with the drug in each patient.
15776110|NCT04645407|Drug|Fuzheng Huayu tablet|Fuzheng Huayu tablet (0.4g/tablet, 1.6g/time, 3 times/day, oral; take medicine after meals each time)
15776111|NCT04645394|Dietary Supplement|Aronia melanocarpa|Administered once (acute study)
15776112|NCT04645394|Dietary Supplement|Fermented Aronia Melanocarpa high dose|Administered once (acute study)
15776113|NCT04645394|Dietary Supplement|Fermented Aronia Melanocarpa low dose|Administered once (acute study)
15776114|NCT04645394|Dietary Supplement|Placebo|Administered once (acute study)
15776115|NCT04645368|Drug|bovhyaluronidase azoxymer|3000 IU intramuscularly once every 5 days with a course of 15 injections
15776116|NCT04645355|Drug|Guselkumab|All subjects will initially be treated with guselkumab 100 mg SQ at weeks 0, 4, and then every 8 weeks thereafter until week 44
15776117|NCT04645342|Device|Baylis Versacross RF wire|Baylis Versacross radiofrequency wire is used for transseptal puncture during cardiac ablation procedure.
15776118|NCT04645342|Device|Baylis RF needle|Baylis radiofrequency needle is used for transseptal puncture during cardiac ablation procedure.
15776119|NCT04645329|Device|shoulder immovilization sling|immobilization of the arm after surgery
15776120|NCT04645316|Drug|Sevoflurane|In the sevoflurane group (n = 25), after the induction of anesthesia with 2 mg / kg propofol and 1 µg / kg remifentanyl, rocuronium 0.6 mg / kg will be given for intubation. In this group, the Sevoflurane concentration will be adjusted between 1-2%, the BIS value will be 40-60, and it will be inhaled with an air / O2 mixture to be FiO2: 0.4.
15776121|NCT04645316|Drug|Desflurane|In the desflurane group (n = 25), after induction of anesthesia with 2 mg / kg propofol and 1 µg / kg remifentanyl, rocuronium 0.6 mg / kg will be given for intubation. In this group, Desflurane concentration will be adjusted between 6-8%, BIS value will be 40-60 and it will be inhaled with a mixture of air / O2 mixture to be FiO2: 0.4.
15776149|NCT04645030|Diagnostic Test|Ultra low-dose computer thermography|The ULD-CT scan will be executed according to a standardized predeveloped technical protocol. The technical protocol will differentiate between patients with BMI <25 and >25 to insure optimal ULD-CT image quality.
15776268|NCT04644055|Diagnostic Test|EUS- share wave of the liver|Evaluation of the right and left hepatic lobe with EUS-guided share wave
15776122|NCT04645316|Drug|Propofol|In the propofol-remifentanyl group (n = 25), rocuronium 0.6 mg / kg will be administered for intubation after 2 mg / kg propofol and 1 µg / kg remifentanil. Maintenance of anesthesia will be adjusted to be between 10 mg / kg / h for the first 10 minutes, 8 mg / kg / h for the following 10 minutes, and then by 6 mg / kg / h propofol infusion, with the BIS value between 40-60. Patients in this group will be inhaled with a mixture of air / O2 to be FiO2: 0.4. Inhalation anesthetics will not be used in this group.
15776123|NCT04645303|Drug|hyaluronic acid (20 mg/2 mL)|A1-Pulley infiltration for trigger finger
15776124|NCT04645303|Drug|Triamcinolone acetonide 10mg/ml|A1-Pulley infiltration for trigger finger
15776125|NCT04645290|Behavioral|"Intervention group: Educational Intervention KARER"|"Multicomponent and interdisciplinary intervention on the care ability and burden of family caregivers. It consists of:
~Virtual componet
~Module 0: the introduction
~Module 1: called Identifying my role as a caregiver
~Module 2: called Strategies to strengthen care
~Module 3: called Strengthening my caring skills
~Face-to-face componed - Two seasons of 4 hours each
~Simulation component
~- One season of practices abilities of 4 hours."
15776126|NCT04645277|Device|Scanning with magnetic resonance imaging|Facial nerves and adjacent blood vessels are scanned using MRI in the patients with hemifacial spasm (HFS). Then multiplanar reconstruction (two dimensional), along with curved planar reconstruction and magnetic resonance virtual endoscopy (three dimensional), will be performed in the different groups of HFS.
15776128|NCT04645238|Other|Static Stretching|Static hamstring stretching exercise lasting 30 seconds and 10 repetitions under the supervision of the physiotherapist
15776129|NCT04645238|Other|PNF Stretching|PNF hold-relax stretching technique that consists of 10 seconds isometric contraction, 30 seconds hamstring stretching and 10 repetitions under the supervision of the physiotherapist
15776130|NCT04645225|Device|. MEFV genetic testing|For mutation analysis, 2 ml blood will be with drawn from both patient and control groups in order to obtain genomic DNA. Extraction of DNA molecule from peripheral blood lymphocytes will be done using standard procedures, then amplification of MEFV gene will be done by polymerase chain reaction(PCR). Reversed hybridization technique will be used for identification of MEFV gene mutation.
15776131|NCT04645212|Biological|ADVM-022|Long term follow-up of subjects that received ADVM-022
15776132|NCT04645186|Device|bone graft substitute|Filling bone defects in current clinical practice
15776133|NCT04645173|Device|CIED envelope|Evaluation of the difference in cohorts for soft tissue healing surrounding the CIED implant and clinical outcomes and complications.
15776137|NCT04645134|Behavioral|Brain Health Assessments|The investigators are enrolling up to 24 healthy, older adults (ages 65-85 y, BMI 20-35 kg/m2) stratified by current physical activity level (12 inactive vs. 12 highly active). Each physical activity group (inactive and highly active) will undergo a blood draw, body composition, resting metabolic rate, cognitive testing, and magnetic resonance (MR) imaging.
15776138|NCT04645121|Device|Carbon Monoxide-based Rebreathing|6 minutes Carbon Monoxide-based Rebreathing that estimate blood volume, plasma volume and erythrocyte volume.
15776139|NCT04645121|Device|Bioimpedance|Measures total volume, intra and extracellular volume.
15776140|NCT04645121|Radiation|Radioactive labelling of erythrocytes and albumin|Measure blood volume, plasma volume and erythrocyte volume.
15776141|NCT04645108|Behavioral|Noom Healthy Weight; mobile behavior change program for weight loss with 1:1 coaching|"The intervention consists of a curriculum, provided through daily articles that users are encouraged to read; logging features for weight, meals, and physical activity; in-app groups; and a virtual coach, who will communicate with participants via in-app messaging. During the first week of the study, participants will be introduced to the program, the Noom app, and their coach.
~Coaches will use a secure dashboard to monitor patient progress, which is used to increase engagement and motivation. Participants are encouraged to log their weight and physical activity on a weekly basis, and meals daily."
15776142|NCT04645108|Behavioral|Noom Healthy Weight; mobile behavior change program for weight loss|The intervention consists of a curriculum, provided through daily articles that users are encouraged to read; logging features for weight, meals, and physical activity. During the first week of the study, participants will be introduced to the program, and the Noom app.
15776143|NCT04645095|Device|Transcutaneous electrical nerve stimulation|All groups were administered hotpack for 20 minutes, different types of TENS therapy for 20 minutes, 5 days a week, total of 15 sessions.
15776144|NCT04645095|Device|Hot pack|All groups were administered hotpack for 20 minutes, different types of TENS therapy for 20 minutes, 5 days a week, total of 15 sessions.
15776145|NCT04645082|Diagnostic Test|x-ray examination|A total of 40 individuals who underwent an axial x-ray examination of the lower extremity following ankle sprain were included.
15776146|NCT04645069|Biological|ADG126|ADG126 will be administered IV over 60-90 minutes with planned doses every three weeks for the first 4 cycles. If no intolerable toxicities occur during the first consecutive 4 treatment cycles, administration of ADG126 may continue every 3 weeks (Q3W) for up to 2 years per agreement with investigator and medical monitor.
15776147|NCT04645056|Other|Stretching and Mobility exercises for neck and shoulder|9 specific stretching and mobility exercises performed 3 times every day the first 4 weeks after surgery.
15776148|NCT04645043|Other|US_Eso|After applying ultrasound guided esophageal pressure, the peak inspiratory pressure increased from 10cmH2O to 24cmH2O (increased by 2 cmH2O) during mask ventilation.
15776150|NCT04645030|Diagnostic Test|lung ultrasound|"LUS will be performed by trained researchers. Before inclusion researchers preforming LUS scans, will undergo a training program and will complete 25 supervised LUS scans to be certified in LUS. At the end of the training program, researchers will be tested to insure proficiency in LUS.
~LUS will be performed according to LUS protocol with seven scanning's zones on each side; 2 anterior, 2 lateral and 3 posterior."
15776151|NCT04645017|Behavioral|Intergenerational Music Program|Music activities will be lead by adolescent musicians for older adult participants.
15776152|NCT04645004|Drug|Aspirin 81Mg Ec Tab|one tab daily
15776153|NCT04644991|Other|Kinesiology taping|Y-type kinesiology tape will be applied to the thoracolumbar fascia in experimental gruoup.
15776154|NCT04644991|Other|Six minutes walking test|Participants will be asked to walk as fast as they can for 6 minutes.
15776155|NCT04644991|Other|Shame Kinesiology Tape|Sham kinesiology tape will be applied to the thoracolumbar fascia in sham gruoup.
15776156|NCT04644978|Other|anonymous online survey|An online questionnaire will be provided for the participants of our study. Participation in the study is voluntary and it can be terminated at any time without having to give any reasons.
15776157|NCT04644965|Diagnostic Test|CombynTM Function & Spaces ECG|Multi-frequency impedance measurement to assess the muscle and fat mass
15776158|NCT04644965|Diagnostic Test|Blood Taking|Sampling of blood of the finger pad to assess liver function
15776159|NCT04644965|Diagnostic Test|Spiroergometry|Spiroergometry to assess cardiopulmonary capacity. The intensity will be raised in steps until total exhaustion. In between each step we will take blood of the ear lobe to determine the lactate level
15776160|NCT04644965|Diagnostic Test|Dordel Koch Test (DKT)|Dordel Koch Test (DKT) to evaluate the motor activity. The DKT is a heterogeneous test battery for children and adolescents and consists of seven parts: lateral jumping, sit and reach, situps, long stand jump, one-legged stand, push-ups and 6-min-run
15776161|NCT04644965|Diagnostic Test|Ultrasound|Ultrasound for abdominal wall muscles
15776162|NCT04644965|Diagnostic Test|Stance and gait analyses|Stance and gait analyses for measuring the core stability
15776163|NCT04644952|Other|Electronic Health Record Review|Review of medical records
15776164|NCT04644939|Other|Phone calls|Patients undergoing outpatient colonoscopy will receive the standard bowel preparation instructions and a telephone call one day before the procedure to re-explain the instructions and the importance of bowel preparation
15776165|NCT04644939|Other|Standard bowel preparation|Patients undergoing outpatient colonoscopy will receive the standard bowel preparation instructions
15776166|NCT04644939|Other|Colonoscopy|Patients will undergo colonoscopy
15776167|NCT04644926|Procedure|Remote ischemic conditioning|Remote ischemic conditioning (RIC) procedure comprise three repetitions of brachial cuff inflation to 200 mmHg for five minutes following deflation to 0 mmHg for another five minutes. The procedure overall took 30 minutes.
15776168|NCT04644913|Behavioral|Quality of life questionnaire|Sending of 2 questionnaires (SF 36 and TESS)
15776169|NCT04644900|Other|chewed mint gum|In the preoperative waiting area before transferring to the operating room,patients in group G chewed mint gum for 2 minutes and then spit it out.
15776170|NCT04644900|Other|Mouthwash|Patients in the mouthwash group took 15 ml honeysuckle antibacterial mouthwash in their mouths, and vomited them out after 2 minutes
15776171|NCT04644887|Other|Dietary intervention: Healthy diet|Dietary guidance in the intervention group is based on the Nordic and Finnish nutrition recommendations with an emphasis on the quality of dietary fat. The aims for the intake of fatty acids will be SFA < 10 % of energy intake (E%) and mono- and polyunsaturated fatty acids (UFA) >2/3 of the total fat intake. The key food products such as vegetable oil-based spread, liquid margarine and canola oil are provided to the participants. The participants are recommended to use fat free (e.g. milk, sourdough milk and yogurt) and low fat (e.g. cheese ≤ 17%) dairy products and low-fat meat, poultry, and fish as well as natural nuts and seeds.
15776172|NCT04644887|Other|Dietary intervention: Control diet|The control diet corresponds to the average nutrient intake in the Nordic countries, i.e. the intake of SFA about 15 E% and the proportion of UFA about 50 % of total fat intake. The participants of the control group will get butter-based spread for bread and cooking. They are recommended to use semi-skimmed milk (1,5 %), normal fat yogurt (~2%), normal fat cheese (~24-35 %) and avoid consumption of vegetable oils. They are allowed to eat a portion of fish and nuts once a week.
15776173|NCT04644874|Diagnostic Test|Geriatric 8|The G8 is an eight-item screening tool, developed for older cancer patients. The G8 score ranges from 0 (heavily impaired) to 17 (not at all impaired), with a cut-off for potential frailty of ≤14.
15776174|NCT04644874|Diagnostic Test|modified Geriatric 8|The mG8 is a modified version of the Geriatric 8 screening tool, consisting of 6-items. The mG8 score ranges from 0 (not at all impaired) to 35 (heavily impaired), with a cut-off for potential frailty at ≥6.
15776175|NCT04644874|Diagnostic Test|30 second chair stand test|Repetitions within 30 seconds
15776176|NCT04644874|Diagnostic Test|Handgrip Strength Test|Measured in kilograms
15776177|NCT04644861|Other|Program of adapted physical activity|3 workouts of one hour every week during 4 months. Program will be conducted by adapted physical activity teachers and sports doctor.
15776178|NCT04644848|Diagnostic Test|Ultrasonographical tattooing of suspicious axillary lymph nodes.|"Patients with clinically negative axillae scheduled for sentinel lymph node biopsy (SLNB) will have axillary ultrasonographical imaging of the ipsilateral axilla with a high-frequency linear probe. Suspicious lymph nodes are identified according to any of the following criteria:
~Round shape.
~Cortical thickness > 3 mm
~Eccentric cortical thickness.
~Loss of hilum.
~For each patient, node dimensions and the presence of each of the above-mentioned criteria are recorded. Tattooing of all suspicious nodes is done using I ml of sterile liquid charcoal."
15776179|NCT04644848|Procedure|Sentinel lymph node biopsy|Sentinel node biopsy is performed with peri-areolar subdermal injection of 3 ml methylene blue 5%. The lymphatics are tracked to the first blue lymph node. All blue, enlarged and /or tattooed nodes are separately biopsied and labelled as SLN and/or tattooed node.
15776180|NCT04644848|Diagnostic Test|Histopathological examination of the axillary nodes|"All tattooed nodes are excised and sent to frozen section examination; labelled tattoo node.
~All enlarged or blue stained nodes are excised and sent to frozen section examination; labelled sentinel node.
~All nodes are bisected and a single 5 um section examined. All frozen section examinations are followed by routine paraffin section examination."
15776181|NCT04644848|Procedure|Further axillary management|Further axillary management is performed as per institutional guidelines. If SLNB is negative, no further surgery is required. Axillary lymph node dissection is performed if sentinel lymph node is positive or not identified. Management of positive SLNB as per the American College Of Surgeons' Oncology Group (ACOSOG) Z0011 protocol is not currently adopted on routine basis at the investigators' institution. In this study, patients with tattooed nodes with positive histopathological findings are offered full axillary dissection even if their sentinel nodes are negative.
15776182|NCT04644835|Device|Low Energy Shock Wave Treatment|The shock wave applicator (Dornier AR2, shock wave device, Dornier MedTech 2010, Wessling, Germany) will be gently placed directly on the ultrasound transmission gel over the skin surface of the suprapubic region above the urinary bladder at the site of the papillary lesion (ultrasound guided) and at other five points. Points 1 and 2 will be at the level of transverse crease 2 cm above the pubic bone and 5 cm from each, points 3 and 4 will 2 cm above points 1 and 2, and point 5 will be centered of points 1-4. A total of 2000 pulses at 0.25 mJ/mm2 will be delivered with a frequency of 3 pulses per second. The position of the shock wave applicator will be changed after every 400 pulses.
15776183|NCT04644835|Device|Sham Treatment|The patients will be exposed to the same therapy head, which will also be fitted with a stand-off without energy transmission.
15776184|NCT04644822|Diagnostic Test|[18F] PSMA-1007 Injection|a novel [18F] PSMA radiotracer that is highly selective for PSMA.
15776185|NCT04644809|Drug|LY3561774|Administered SC.
15776186|NCT04644809|Drug|Placebo|Administered SC.
15776189|NCT04644783|Diagnostic Test|Blood test assay|Participants will have their blood drawn and be evaluated with a new blood assay that screens a large number of foods (more than 20) in a culture plate. Participants will be asked to eat the identified safe foods by the the blood assay.
15776190|NCT04644770|Drug|JNJ-69086420|Participants will receive IV injection of JNJ-69086420.
15776191|NCT04644757|Other|Music Listening|The study will employ an individual receptive relaxation music method with participants selecting music based on their preference from a selection of various styles from the MUSIC CARE© app. The music intervention will last 20 minutes per session and will be administered twice daily for 4 consecutive days. Participants will be given an electronic tablet with the MUSIC CARE© app loaded on it and trained on how to access the app to select their preferred style of music.Participants will be instructed to use the provided headphone during all interventions and to sit in a quiet area while wearing an ocular mask to avoid distractions.The PI will remotely monitor each of the music intervention sessions in real-time monitoring via a secured video conferencing interface to ensure adherence to study protocol.
15776192|NCT04644744|Device|Hypothermic oxygenated perfusion (HOPE)|HOPE for 1 hour via the portal vein in a recirculating and pressure controlled system (2-3 mm Hg), 0.1 ml/g liver/min, perfusion volume 3-4 L, Belzer (UW) machine perfusion solution, perfusate temperature 10 °C, perfusate oxygenation pO2 of 60-80 kPa
15776193|NCT04644744|Device|Normothermic machine perfusion (NMP)|End-ischemic NMP will be continued throughout the recipient hepatectomy and until the transplanting team is ready to implant the liver. The minimum protocol-stipulated NMP duration is 4 hours, the time needed for ATP repletion in animal studies. Total NMP preservation time will be according to the official recommendations of the manufacturer (4-24 hours) and at the discretion of the local transplant centre. The liver allograft will be disconnected from the OrganOx metra® device immediately prior to transplantation and flushed with three litres of HTK via the hepatic artery and the portal vein.
15776194|NCT04644731|Device|Aquadex™ System|Ultrafiltration for fluid removal
15776195|NCT04644718|Device|Transcranial direct current stimulation (tDCS)|tDCS will be administered using a battery driven stimulator along with intensive SLT. The anode electrode (5-7cm2) will be placed over the left M1 while the cathode will be positioned over the controlateral supraorbital area in both groups ((Lindenberg et al., 2013; Meinzer et al., 2016; Stahl et al., 2019), (based on the 10-20 EEG system) (Darkow et al., 2017). Stimulation will be provided via an electrode using a Soterix device (Soterix Medical Inc., New York, NY). During sham tDCS (control group), the current will be ramped up and remained for 30 s at (2 mA) before ramping down, which does not affect neural functions, but assures effective blinding of participants due to the initial tingling sensation on the scalp (Gandiga et al., 2006). Both groups will receive a total of 30 consecutive stimulation sessions over six weeks.
15776196|NCT04644705|Drug|Niclosamide|Niclosamide will be applied in various dosage steps, galenic preparations and in combination with camostat
15776197|NCT04644705|Drug|Placebo|placebo to the interventional drug
15776198|NCT04644692|Other|Lung ultrasound|A lung ultrasound before and at the end of the stress test.
15776199|NCT04644679|Diagnostic Test|7-day electrocardiographic monitoring|7-day external electrocardiographic monitoring
15776200|NCT04644679|Diagnostic Test|48-hr electrocardiographic monitoring|48-hr external electrocardiographic monitoring
15776201|NCT04644640|Other|Telerehabilitation Therapy|Rehabilitation services will be dispensed at patients' home utilizing video telecommunication services with real-time synchronous exchange of information - range of motion exercises for the knee, proprioception and balance training
15776202|NCT04644640|Other|In-person Rehabilitation Therapy|Range of motion exercises for the knee, proprioception and balance training
15776203|NCT04644627|Drug|Gentamicin Sulfate|Topical gentamicin ointment on wounds once daily for 6 weeks
15776204|NCT04644614|Device|Magnetic Stimulation - Armchair type|MS and Sham MS will be applied two days a week, 20 minutes a day, for 8 weeks, a total of 16 sessions.
15776205|NCT04644588|Diagnostic Test|Children with hemiparetic cerebral palsy being assessed for scapular alignment and upper limb function.|Children with hemiparetic cerebral palsy being assessed for scapular alignment and upper limb function.
15776206|NCT04644575|Drug|efanesoctocog alfa (BIVV001)|Pharmaceutical form:Solution for Injection Route of administration: Intravenous
15776207|NCT04644562|Other|Erector Spinae plane block|Ultrasound-guided lumbar Erector Spinae plane block in patients undergoing Lower Limb vascular Surgery
15776208|NCT04644536|Device|Bone graft substitute|Orthopaedic or Spine bony defects
15776209|NCT04644523|Other|Dermoscopy|"dermoscopy is currently used in daily practice in dermatology, for melanoma screening. Dermoscopy will be used in this study on peri-ungueal area.
~This is a non-invasive and painless exam."
15776210|NCT04644510|Device|Lung ultrasonography|Standardized eight-point Lung ultrasonography
15776211|NCT04644497|Procedure|ACL-reconstruction|Surgery technique in skeletally immature patients
15776212|NCT04644484|Biological|SYN023|The finished product of SYN023 is a mixture of 3.0 mg/mL CTB011 and 3.0 mg/mL CTB012 at a ratio of 1:1. SYN023 is a sterile and preservative-free injection, and the excipient contains 25 mM histidine (3.879 mg/mL), 150 mM sodium chloride (8.766 mg/mL) and 0.02% polysorbate 80 (0.2 mg/mL) and pH of 6.0. Each vial contains 2.15 mL of SYN023, or 6.45 mg of mAb. The glass bottle was closed with a 13 mm bromobutyl rubber stopper, a 13 mm aluminum crimping cap and a polypropylene flip-open lid.
15776213|NCT04644484|Biological|HRIG|The HRIG is a Chinese licensed Human Rabies Immunoglobulin, which are derived from human plasma, and then purified and filled in the injectable vial form. The HRIG is indicated for the Post-exposure Prophylactic (PEP) of Rabies
15776214|NCT04644484|Biological|Rabies Vaccine|Interventions: The Chinese licensed rabies vaccine should be administered in deltoid muscle Dosage form: >=2.5 IU, freeze-dried vaccine, reconstitute into 0.5 mL before use Dosage: 0.5 mL after reconstitution Frequency/duration: at Day 1, 4, 8, 15, 29
15776215|NCT04644471|Diagnostic Test|CT scanner|1 conventional low dose inspiratory acquisition and 1 ultra-low-dose inspiratory acquisition
15776216|NCT04644471|Diagnostic Test|Lung MRI|3 UTE sequences (free breathing, inspiratory and expiratory) and 1 T2 sequence
15776217|NCT04644458|Other|Measuring the ulna length using meauring tape|the left ulna will be measured with a measure tape from the olecranon to mid point of styloid process.
15776218|NCT04644445|Dietary Supplement|Bariatric Full Liquid Diet|Patient's will receive a Bariatric Full Liquid Diet (standard bariatric clear liquid diet + protein shakes) to be started 4 hours after surgery
15776219|NCT04644432|Drug|Medication (A specification is listed under each arm)|Study drugs and dosages are listed in the description of arms.
15776220|NCT04644432|Other|Patient reported outcomes measurement|"PRO questionnaires regarding symptoms and side effects with questions selected from the Nation Cancer Institute Patient Reported Outcomes-Common Terminology Criteria for Adverse Events.
~The patient receive individual advices according to the patient's answers to reduce the symptoms and side effects or is instructed to contact the hospital.
~For monitoring quality of life the EORTC QLQ-C30 is used. All questionnaires are in Danish."
15776221|NCT04644419|Other|Palliative And supportive Care inTervention (ACT)|This ancillary study does not include intervention development component. The detail intervention can be found in the parent study protocol (NCT04570709).
15776222|NCT04644406|Other|Efficacy of the Pertuzumab-Trastuzumab combination|The efficacy of the pertuzumab in combination with one of the biosimilars of Trastuzumab will be estimated by measuring the PFS at 6 months after the beginning of the treatment.
15776223|NCT04644380|Device|INVOcell|Female participants undergoing in vitro fertilization (IVF) and or/or Intracytoplasmic Sperm Injection (ICSI) for assisted reproductive will be asked to participate
15776224|NCT04644367|Other|Tai Chi intervention|TC classes will be 60 minutes long, offered three times per week over a 12-week period. The participants who receive the TC intervention will be encouraged to attend at minimum two of the three sessions offered per week. The TC classes will follow the same order that will begin with a 5 to 10 minutes warm up, 40 minutes of core activities, and 5 minutes of cool-down. The training intensity and difficulty level of the TC program will gradually proceed from low, moderate, to advance. The classes will be offered in a group setting at a convenient location within a community centre or gymnasium. Alternatively, classes will be offered outdoors in the park or by the canal during the spring-summer months. Due to the COVID-19 situation, additional adaptive measures will be taken using online social platforms such as ZOOM or Hangout to deliver the classes.
15776225|NCT04644367|Other|Regular Physical Activity (control) group|Regulary Physical Activity group who will not be receiving the TC intervention
15776226|NCT04644354|Drug|Nifedipine 10 mg|For both groups, when preterm labor is diagnosed, 10 mg capsule will be given sublinguially and if it is not effective in 1 hour, the same dose will be repeated again, and the same regimen will be repeated every day till preterm labor ends or proceed to a preterm birth.
15776227|NCT04644341|Combination Product|cardiovascular and respiratory systems monitoring|only one group of individuals to observe the impact of COVID-19 on their cardiovascular and respiratory systems in long term.
15776228|NCT04644328|Behavioral|Facebook Ads on the importance of staying safe during the Thanksgiving / Christmas holiday|Facebook ads to show a 15 second video clip recorded by MGH, Harvard and Lynn Community health center and other health care professionals to approximately 20,000,000 Facebook users. The ads will be shown before the Thanksgiving/Christmas holiday and will focus on staying safe - limiting travel, social distancing and mask-wearing. The investigators will randomize exposure to the ad campaign at the ZIP code or county level.
15776230|NCT04644302|Diagnostic Test|microcirculation recording|non-invasive recording of sublingual microcirculation and blood sampling together with regular withdraws
15776231|NCT04644289|Drug|olaparib|Olaparib tablets are administrated orally 300 mg twice daily.
15776232|NCT04644289|Drug|durvalumab|Durvalumab is administered 1500mg iv as a single dose prior to surgery (corresponding to 1 single cycle) .
15776233|NCT04644276|Device|Mask with Mask Adhesive/Arm 1|Patients will be randomized to Arm1 if they receive the mask adhesive and mask on the first study night then the mask without the mask adhesive on the second study night.
15776234|NCT04644276|Device|Mask without Mask Adhesive / Arm 2|Patients will be randomized to Arm 2 if they receive the mask without mask adhesive on the first study night then the mask adhesive with the mask on the second study night.
15776235|NCT04644250|Drug|Toripalimab|Participants will also receive Toripalimab(240mg) VD 30 min on days 3, 24 and 45，3 cycles in total.
15776236|NCT04644250|Drug|Paclitaxel liposome/Carboplatin|Participants will receive carboplatin (AUC=2) VD 30min and paclitaxel liposome (50mg/m²) CIV 24h on day 3,10,17,24,31, 5cycles in total.
15776237|NCT04644250|Radiation|Intensity-modulated radiotherapy|A total of 41.4 Gy, 23 fractions of 1.8 Gy on Day 1 to 31.
15776266|NCT04644068|Drug|Paclitaxel|IV Anti-microtubule agent
15776238|NCT04644237|Drug|Trastuzumab deruxtecan|Trastuzumab deruxtecan 100 mg will be provided as a sterile lyophilized powder and reconstituted with 5 mL water for injection (final concentration 20 mg/mL [ie, 100 mg/5 mL]). The study drug will be administered as an intravenous (IV) infusion over 30 to 90 min Q3W ± 2 days. The initial dose of study drug will be infused for 90 ± 10 min.
15776239|NCT04644224|Other|Educational Activity|Attend health coaching session
15776240|NCT04644224|Other|Educational Intervention|Attend resource navigation session
15776241|NCT04644224|Other|Informational Intervention|Receive handbook
15776242|NCT04644224|Other|Questionnaire Administration|Ancillary studies
15776243|NCT04644224|Procedure|Support Group Therapy|Attend support group
15776244|NCT04644211|Drug|Ruxolitinib|Pill taken by mouth.
15776245|NCT04644198|Biological|Convalescent Plasma Infusion|250 mls of convalescent plasma on day 1 & 2.
15776246|NCT04644185|Drug|SCTA01|SCTA01, a recombinant anti-SARS-CoV-2 spike protein monoclonal antibody
15776247|NCT04644185|Other|Placebo|all SCTA01 excipients without active component+best supportive care
15776248|NCT04644172|Behavioral|Speed of Processing Training|"Testing involves trainer-guided practice of computerbased video games. The games require the player to identify targets that are presented very briefly. In the first level, the player has to identify a target at the center of the screen. In the second level, the player has to identify targets at the center and edge of the screen simultaneously. In the third level, other objects, which serve as decoys, are added. SOPT is aimed at improving the fluidity of mental processing speed (not psychomotor reaction time) so that trainees can process more complex information over briefer periods of time. The training involves practice with feedback. The trainer teaches some task-specific strategies, offer suggestions, encouragement, and personalized modification of difficulty for enhancing performance. Speed and task difficulty level are tailored to trainee ability, trainees practice blocks of 16 trials with a goal of achieving performance of 10 to 12 correct trials for each training block."
15776249|NCT04644172|Behavioral|Instrumental Activities of Daily Living Shaping|In addition to training on the SOPT software, participants will train on tasks that simulate everyday activities that have important cognitive components (e.g., selecting medicine bottles from a cabinet, measuring ingredients to bake a cake, finding information online). The training will follow shaping principles. Activity periods will be divided into trials of specific length, and the performance of the participant will be measured and graphed to provide the participant with feedback on their performance. Verbal praise will be used to reward a participant for improvements in performance. The difficulty of the task will be increased in small increments as a participant gains mastery. The purpose of this component is to serve as a bridge between the SOPT training, which exercises a basic aspect of cognitiven function, and cognitive function in everyday life, which is embedded in the context of multi-part, and multidimensional tasks.
15776250|NCT04644172|Behavioral|Transfer Package from CI Therapy|Behavioral Contract. At the outset of treatment, the therapist negotiates a contract with the participant and caregiver, if one is available.Daily home diary. During treatment, the participants catalog the ADL and IADL for the part of the day spent outside the laboratory. Daily administration of the Cognitive Task Activity Log (CTAL). The CTAL collects information about attempts by the participant to complete ADL and IADL. Problem Solving. The therapist helps participants to think through any barriers to completing ADL and IADL independently. Home skill assignments during treatment. Participants are assigned on a written check-off sheet 10 specific ADL tasks. Home skill assignments after treatment. Toward the end of treatment, a written individualized post-treatment program is developed containing a list of up to 10 IADL for each day of the week. Post-treatment telephone contacts. Participants are contacted during the 12 month period after treatment to evaluate treatment outcomes.
15776251|NCT04644172|Other|Usual Care|Healthcare that is available for adults with cognitive impairment subsequent to COVID-19 in the community on a clinical basis. This includes commercially available, gamified, computerized cognitive training programs.
15776252|NCT04644159|Other|Human biological samples|Blood , saliva, nasopharyngeal mucosa
15776253|NCT04644146|Genetic|GENETIC|It is a retrospective study on patients which has been hospitalized since the beginning of the COVID-19 pandemic in Lyon (march 2020). The blood samples have been collected I the frame of the regular follow-up of the patients and DNA extracted and conserved for the various research protocols ongoing in the University Hospital. The DNA will be analyzed by next generation sequencing
15776254|NCT04644133|Other|Paper diary|Subjects will be asked to complete a 2 week paper stool diary.
15776255|NCT04644133|Other|Electronic APP diary|Subjects will be asked to complete a 2 week paper stool diary.
15776256|NCT04644120|Drug|ABBV-47D11|Intravenous (IV) infusion.
15776257|NCT04644120|Drug|Placebo for ABBV-47D11|Intravenous (IV) infusion.
15776258|NCT04644120|Drug|ABBV-2B04|Intervenous (IV) Infusion
15776259|NCT04644120|Drug|Placebo for ABBV-2B04|Intervenous (IV) Infusion
15776260|NCT04644107|Drug|Marizomib|Marizomib will be administered via IV
15776261|NCT04644094|Other|Echocardiography (ECHO) and lung ultrasound (LUS) studies before and after Dexamethasone administration|"A. Electrocardiographic (ECG) leads will be place in the patient for electrocardiogram (ECG) recordings.
~B. Echocardiography (ECHO) will be performed by an expert member of the Neonatal Echocardiography team C. Heart Rate Variability (HRV): ECG recordings D. Growth trajectory: body weight, length, head circumference, length/weight ratio at 1-, 2-weeks prior treatment, 1-, 2-, 3-, 4-,6-,8-weeks after treatment, at 36-week PMA."
15776262|NCT04644081|Behavioral|LTP|LTP is a low-literacy, sustainable programme that will provide depressed mothers with valuable skills on parenting, improve mother-child relation and mental health self-care. This is a research-based activity that enhances postpartum mental health while simultaneously promoting attachment security through building parents' ability to monitor and be sensitive to their children's cues, and thereby, actively involves in their children's mental and physical development.
15776263|NCT04644081|Behavioral|CaCBT|CaCBT adopts 'here and now' problem-solving approach, which involves collaborating with families, active listening techniques, changing negative thinking, and depressive symptoms associated with postnatal depression and other forms of parenting distress.
15776264|NCT04644081|Drug|TAU|TAU is the routine care currently available for the treatment of postnatal depression at the primary health care sites of intervention (e.g. antidepressants and other forms of mental health care).
15776265|NCT04644068|Drug|AZD5305|Oral PARP inhibitor
15776269|NCT04644042|Procedure|Glenohumeral arthroscopy + Arthroscopic Subacromial Decompression|In addition to the glenohumeral athroscopy a lateral portal (approximately 2-3 cm distal to the lateral edge of acromion) will be used to access the subacromial space. The subacromial space will be decompressed with removal of inflamed bursal tissue and acromioclavicular osteophytes, release of the coracoacromial ligament, and, if deemed necessary by the surgeon, acromioplasty performed ad modum Caspari.
15776270|NCT04644042|Procedure|Glenohumeral arthroscopy + lateral skin incision|Glenohumeral arthroscopy is performed as a standard investigational procedure. The patient is put under general anesthesia and positioned in the 'beach chair position'. An anteriorsuperior portal (approximately 3 cm inferior and 2 cm medial to the anterior edge of acromion) and a posterior mid-glenoid portal (approximately 2 cm inferior and 1 cm medial to the posterolateral corner of acromion) are used as entry to the joint. The following structures are investigated as a minimum: the articular surface of the humeral head and the glenoid, labrum, the long biceps tendon and its attachment at the superior labrum, the undersurface of the supraspinatus and the infraspinatus tendon, the subscapularis tendon and the glenohumeral ligaments. To allow for the best possible blinding a skin incision (mimicking the one used for arthroscopic subacromial decompression) is performed on the lateral side of the shoulder of the participants in the control group.
15776275|NCT04644016|Drug|Clofarabine|Clofarabine 30 mg/m2
15776276|NCT04644016|Drug|Fludarabine|Fludarabine 10 mg/m2
15776277|NCT04644016|Drug|Busulfan|Busulfan per PK
15776278|NCT04644016|Drug|Cyclosporine-A|GVHD prophylaxis will consist of cyclosporine-A (CSA) and mycophenolate mofetil (MMF) starting day -3.
15776279|NCT04644016|Drug|Mycophenolate Mofetil|GVHD prophylaxis will consist of cyclosporine-A (CSA) and mycophenolate mofetil (MMF) starting day -3.
15776280|NCT04644016|Biological|Cord Blood Graft|The CB graft will be infused on day 0 per standard practice
15776281|NCT04644003|Drug|STP1|STP1 is a combination of two drugs, a PDE inhibitor and an NKCC1 inhibitor
15776282|NCT04644003|Drug|Placebo|Placebo medication (capsule and tablet) identical in appearance to active medication
15776283|NCT04643977|Device|mARG-01-17 (mesohyal AGRIBENONE)|Dermal Filler
15776284|NCT04643964|Behavioral|Entrée: Cognitive skills|In this condition, participants view a video-based intervention covering cognitive emotion regulation skills. This intervention asks participants to respond to questions and practice identifying and evaluating their own thoughts using an intervention worksheet. One week after the intervention, participants are asked to upload a worksheet showing their efforts to use the intervention skills.
15776285|NCT04643964|Behavioral|Entrée: Behavioral skills|In this condition, participants view a video-based intervention covering behavioral emotion regulation skills. This intervention asks participants to respond to questions and practice scheduling activities that might give them a sense of pleasure or accomplishment using an intervention worksheet. One week after the intervention, participants are asked to upload a worksheet showing their efforts to schedule and engage in behaviors in line with the intervention skills.
15776286|NCT04643964|Behavioral|Entrée: Interpersonal skills|In this condition, participants view a video-based intervention covering interpersonal emotion regulation skills. This intervention asks participants to respond to questions and practice communicating effectively using an intervention worksheet. One week after the intervention, participants are asked to upload a worksheet showing their efforts to use the intervention skills.
15776287|NCT04643964|Behavioral|Sampler skills|In this condition, participants view a video-based intervention covering three emotion regulation skills: cognitive, behavioral, and interpersonal skills. This intervention asks participants to respond to questions and practice using skills using intervention worksheets. One week after the intervention, participants are asked to upload a worksheet showing their efforts to use the intervention skills.
15776288|NCT04643951|Behavioral|Interview|Interview study using Grounded theory, to investigate dental professionals' and students' perception of child patient's experience and need for treatment regarding procedural and postoperative pain.
15776289|NCT04643925|Drug|Ovitrelle|Ovitrelle 260 IE once daily for 8 weeks prior to IVF/ICSI
15776290|NCT04643912|Diagnostic Test|Vibration Device|Device which causes the bone to vibrate and records the spectrum of that vibration
15776291|NCT04643899|Device|Muscle Electrostimulation|"Scheduled sessions of 20 minutes per day; 5 days a week
~In physiotherapy or in their room for the most dependent patients
~Installation and monitoring by a physiotherapist or by the trained clinical research nurse
~Modalities:
~Device program n ° 1: 20mn (2mn of warm-up, 15mn of work at 75hz, then 3mn of recovery)
~4 electrodes (2 per thigh): large model (5 * 10 cm) for better comfort - Dura-Stick Plus model (reference 42200)
~Gradual auto-increase of the intensity to the highest possible value tolerated, nevertheless allowing a contraction"
15776292|NCT04643886|Drug|GEM103|Biological
15776293|NCT04643873|Other|physical activity counseiling +pilates exercise group|It is planned to do the pilates exercises for 50 minutes a day, 2 days a week during 12 weeks with physiotherapist. Pilates group patient will make pilates exercise once a week alone During physical activity counseling, considering the current physical and metabolic status of the person, the person-based 5A model of ACSM will be adapted to individuals with diabetes and physical activity consultancy will be provided
15776294|NCT04643873|Behavioral|physical activity counseiling group|During physical activity counseling, considering the current physical and metabolic status of the person, the person-based 5A model of ACSM will be adapted to individuals with diabetes and physical activity consultancy will be provided. Patients make aerobic and strengthening exercises by theirself based on phyiotherapist's suggestions
15776295|NCT04643860|Diagnostic Test|Differential Leucocyte Count (CLDC) device and algorithm|Boold sample that detecting the early rise in leukocyte levels which has a characteristic set of ratios of leukocyte types, which identify the viral pathogen and distinguish it from a number of others. This test allows prediction of positives from full blood count results.
15776433|NCT04642820|Drug|placebo oral tablet|Participants will be given a placebo capsule that will only contain lactose.
15776296|NCT04643847|Drug|Almonertinib|110mg Almonertinib is administered orally daily since the first day after stereotactic radiosurgery treatment (total dose 30 Gy, 5 fractions, day1, 3, 5, calibrated by CBCT before each treatment). For patients who are assessed as oligometastasis three months after Almonertinib treatment, SBRT is recommended for oligometastatic lesions (The number of lesions received SBRT and radiation dose are not standardized).
15776297|NCT04643821|Drug|N-acetylcysteine, NAC, and calcitriol|iv administration of antioxidant and active vitamin D
15776298|NCT04643808|Device|transcutaneous auricular vagus nerve stimulation|Microcurrent stimulation delivered to the left tragus, with stimulation 'on' during sucking from a bottle, and 'off' at rest during bottle feeding
15776299|NCT04643795|Drug|MGL-3196|Once daily oral dose for 6 days
15776300|NCT04643782|Device|ANNE One System|After consent, subjects will (1) wear the ANNETM One and HST for 1 night, (2) wear the ANNETM One alone for 3 nights, and (3) wear the ANNETM One during an attended PSG study for 1 night.
15776303|NCT04643756|Other|conventional physiotherapy|Classical electrotherapy method consisting of tens, hotpack and ultrasound.
15776304|NCT04643756|Other|conventional physiotherapy plus kinesiotaping|Conventional physiotherapy plus kinesiotaping
15776305|NCT04643743|Device|Endarterectomy|Endarterectomy is a surgical procedure to remove the atheromatous plaque material, or blockage, in the lining of an artery constricted by the buildup of deposits. It is carried out by separating the plaque from the arterial wall.
15776306|NCT04643730|Other|Acupressure methods|Acupressure on the KI3 and St36 points applied to the babies in the acupressure group for a total of 7 minutes before the heel prick
15776307|NCT04643730|Other|Foot Reflexology Methods|Foot reflexology was applied to the babies in the foot reflexology group for a total of 7 minutes before the heel prick
15776308|NCT04643730|Other|Control Grup|No pre-application was made to the babies in the control group as a routine procedure.
15776309|NCT04643717|Other|Electronic pupillometer analysis|Electronic pupillometer analysis
15776310|NCT04643691|Drug|Losartan 50 mg and Spironolactone 25 mg pillules oral use|Losartan 50 mg and Spironolactone 25 mg pillules oral use during 10 days
15776311|NCT04643678|Drug|Anakinra|Patient will receive Anakinra 100 mg SC injection every 12 hours for 3 days, then 100 mg once daily from day 4 to day 7 plus Standard of Care
15776312|NCT04643678|Other|Standard of Care|Patients will receive the Standard of Care therapy as per the local treatment protocol
15776313|NCT04643665|Procedure|Double-lung transplantation|
15776314|NCT04643652|Behavioral|Noise Reduction Bundle|"Implementation of a bundle of noise reducing interventions. This concerns among other things:
~reduction of alarms, phone calls/pagers/ bleepers, introduction of a defined period in which there is a reduction of controllable sound (quiet time), etc"
15776315|NCT04643639|Device|CytoSorb hemoperfusion|Subjects will be treated with CytoSorb hemoperfusion (in stand-alone setup) for 6 hours at a flow rate of 250 ml/min during endotoxemia.
15776316|NCT04643626|Device|artificial intelligence dietary android mobile application|subjects use artificial intelligence dietary mobile application to monitor dietary intake
15776317|NCT04643613|Dietary Supplement|Protison cancer nutritional formula (PCNF)|PCNF (237 mL/Pack) for 5-6 times/day via bolus NG tube feeding for 12 weeks
15776318|NCT04643600|Drug|L-Arginine, 500 Mg Oral Capsule|The strength test of the the quadriceps muscle, will be measured in all patients on the Biodex isokinetic device. Quadriceps strength testing will be performed on 2 occasions. On one occasion without medication, except those that the patient may take permanently, and on the other 90 minutes after the patient takes 1 tbl of L - Arginine 500 mg on mouth to an empty stomach ,in order to monitor the possible increase in quadriceps strength.
15776319|NCT04643587|Biological|CSL787|Human plasma-derived polyvalent immunoglobulin G (IgG) administered via inhalation of an aerosol produced using a nebulizer
15776320|NCT04643587|Drug|Placebo|Normal saline (0.9% NaCl)
15776321|NCT04643574|Other|NeoTIL|Adoptive transfer of ex vivo expanded Autologous Tumor-Infiltrating Lymphocytes enriched for tumor antigen specificity (NeoTIL)
15776322|NCT04643574|Drug|Cyclophosphamide|Cyclophosphamide will be administered as an intravenous (IV) infusion for two days.
15776323|NCT04643574|Drug|Fludarabine|Fludarabine will be administered as an intravenous (IV) infusion for five days.
15776324|NCT04643574|Drug|Interleukin-2|After TIL infusion, IL-2 (optional) will be started as a bolus administration every eight hours, for a maximum of eight doses.
15776325|NCT04643574|Other|Radiotherapy|Low-dose irradiation (1Gy) will be administered using tomotherapy to tumor lesions once before NeoTIL infusion.
15776326|NCT04643561|Other|Travelan OTC|5 days of treatment with Travelan food supplement 3 times a day, blood will be drawn prior and after intervention
15776327|NCT04643522|Other|Clinical assessment|Comparison of semen analysis results and sex-related hormone levels between the dependent groups which were defined as before COVID-19 and after COVID-19 (the data of the same patient group were compared as before and after the diagnosis of COVID-19).
15776328|NCT04643509|Device|Niccomo|Niccomo monitoring added to pulmonary arterial catheter monitoring
15776329|NCT04643496|Procedure|Laparoscopic or open Ileocolic resection|Laparoscopic or open Ileocolic resection
15776330|NCT04643483|Drug|Certolizumab pegol|"Pharmaceutical form: Solution for injection
~Route of administration: Subcutaneous
~Subjects will receive certolizumab pegol in a pre-specified sequence during the Treatment Periods."
15776331|NCT04643483|Drug|Adalimumab|"Pharmaceutical form: Solution for injection
~Route of administration: Subcutaneous
~Subjects will receive adalimumab in a pre-specified sequence during the Treatment Periods."
15776332|NCT04643483|Drug|Placebo|"Pharmaceutical form: Solution for injection
~Route of administration: Subcutaneous
~Subjects will receive placebo in a pre-specified sequence during the Treatment Periods."
15776333|NCT04643470|Drug|Zanubrutinib|Administered as specified in the treatment arm
15776334|NCT04643470|Drug|Placebo|Placebo to match zanubrutinib
15776335|NCT04643457|Drug|UCB9741|- Pharmaceutical form: Solution Participants will receive UCB9741 to maintain the blinding during the Treatment Period.
15776336|NCT04643457|Drug|Intravenous Placebo|- Pharmaceutical form: Solution Participants will receive Placebo to maintain the blinding during the Treatment Period.
15847560|NCT04062305|Other|Quality-of-Life Assessment|Ancillary studies
15776337|NCT04643457|Drug|Subcutaneous Placebo|"Pharmaceutical form: Solution
~Route of administration: Intravenous and subcutaneous use Participants will receive Placebo to maintain the blinding during the Treatment Period."
15776338|NCT04643444|Diagnostic Test|Blood sampling|Testing for the presence of SARS-CoV-2 antibodies
15776339|NCT04643444|Other|Online Questionnaire|Questions on working place, risk profiles and PPE
15776342|NCT04643405|Drug|APG-1387 for Injection|APG1387 will be administered IV days 1， 8, 15 and 22 of a 28 day cycle.
15776343|NCT04643405|Drug|Gemcitabine|Gemcitabine 1000 mg/m^2 will be administered IV days 1, 8, and 15 of a 28 day cycle.
15776344|NCT04643405|Drug|Nab paclitaxel|Nab-Paclitaxel 125mg/m^2 will be administered IV days 1, 8, and 15 of a 28 day cycle.
15776345|NCT04643392|Procedure|Complex decongestive physiotherapy|Each patient received a treatment protocol of Complex decongestive physiotherapy for 5 days a week until they were discharged from the clinic. All patients fully completed all components of the treatment routine daily. The treatment was performed by a physiotherapist who was certified with Manual Lymph Drainage Combined Decongestive Physiotherapy. After the daily treatment protocol was completed, patients wore standard or individually sized compression grade II or III medical compression stockings for the rest of the day.
15776346|NCT04643379|Drug|Olaparib|Supplied by Merck & Co.
15776347|NCT04643379|Drug|Pembrolizumab|Supplied by Merck & Co.
15776348|NCT04643379|Drug|Carboplatin|Commercially available
15776349|NCT04643379|Procedure|Peripheral blood draw|Baseline (cycle 1 day 1), cycle 2 day 1, and at disease progression
15776350|NCT04643366|Drug|Chemotherapy|Neoadjuvant chemotherapy with 2 months of combination oxaliplatin and 5-Fluorouracil, leucovorin, and oxaliplatin (mFOLFOX)
15776351|NCT04643366|Radiation|Radiation Therapy|Pelvic Intensity-modulated radiation therapy (IMRT)
15776352|NCT04643353|Device|Non-ablative vaginal Erbium YAG laser treatment|Laser therapy is performed using a 2940 nm VEL (SP Spectro, Fotona, Slovenia) with SMOOTH mode setting, which enables non-ablative, thermal-only operation. The parameters are selected based on extensive preclinical and clinical studies.
15776353|NCT04643353|Other|PFE|PFE will be prescribed as it is already implemented in clinical practice (i.e. up to 2x 9 sessions with a pelvic floor physiotherapist of choice). Type of physiotherapy, number of completed sessions and duration of therapy will be recorded.
15776354|NCT04643340|Other|real-time fMRI|Brain regions can be trained, i.e. fMRI activity can be actively modulated online by humans, using rt-fMRI (Bruhl, Scherpiet et al. 2014, Bruhl 2015, Emmert, Kopel et al. 2016).
15776355|NCT04643327|Drug|Levetiracetam|Levetiracetam is currently approved in Australia and the U.S.A. for epilepsy. We will be providing levetiracetam in capsule form, 125mg levetiracetam in each capsule.
15776356|NCT04643327|Drug|Placebo|Placebo intervention will be maize-starch filled capsules with identical physical features to the active capsules.
15776357|NCT04643314|Other|Guided video-based self-evaluation|"In addition to their usual residency training, participants randomized to this group will undergo the following interventions:
~The participants will be asked to review their own operating room recordings (of each of the 5 consecutive submitted laparoscopic cholecystectomy cases that the participant acted as the primary operator) and to assess themselves (within 72 hours (3 days) of the procedure) using validated intra-operative assessment tools. The completion of the self-evaluations is to guide and document video-based self-reflection. The duration of self-assessment/reflection session will be up do the participant. Residents in this group will have unlimited access to their recordings through the web-based platform. On the other hand, they will not be able to access the battery of assessment forms after the third day following the procedure."
15776358|NCT04643301|Drug|Liraglutide Pen Injector|Daily subcutaneous injection of 3.0mg liraglutide (GLP-1 antagonist) for low-responders 3 months after bariatric surgery.
15776359|NCT04643288|Procedure|open flap debridement|open flap debridement for managing two and three walls intrabony periodontal defects
15776360|NCT04643288|Procedure|n-HA bone graft|Nanocrystalline Hydroxyapatite bone graft substitute for managing two and three walls intrabony periodontal defects
15776361|NCT04643275|Device|BTL-899|Treatment with study device.
15776362|NCT04643262|Procedure|Sleeve Gastrectomy|Once the left crus is reached, an optimal exposure of the hiatus is mandatory to find incidental hiatal hernias and a complete dissection of the left crus performed to prevent retained fundus. The greater omentum was opened close to the stomach wall in some part in between the fundus and the antrum to have greater curvature completely detached from the stomach; this dissection starts at 2 cm or _____proximal to the pylorus and continued along the greater curvature to the left crus. Posterior adhesions if present, were carefully divided. The left gastrophrenic ligament was divided to expose the angle of His to identify the complete hiatus and fundus. A bougie was positioned before starting resection of the stomach. We use a 36French bougie or --------- we have chosen cartridges Black at the antrum level and finished with a purple cartridge. We always checked the posterior wall before firing.
15776391|NCT04643119|Device|Cruciate-Retaining Insert|The Cruciate-Retaining Bearing (CR Bearing) design was launched together with the use of the Cruciate-Retaining Femoral Components (CR Femur) of the Zimmer-Biomet Persona® Total Knee system. The design not only stabilises the knee through medial conformity and anterior constraint, but also allows for freer and more natural deep flexion through freer movement of the lateral condyle.
15776392|NCT04643106|Procedure|Hemostatic agent (EVICEL®) application during laparoscopic ovarian cystectomy|During laparoscopic ovarian cystectomy, bleeding will be controlled by using a hemostatic agent (EVICEL®)
15776504|NCT04642274|Other|Prevent Thrombosis|Actively prevent thrombosis after surgery.
15776371|NCT04643236|Behavioral|Periodontal health education session|This session comprised of a condensed version of motivational interviewing and a periodontal education view/point. First, patients were analysed in terms of expectations from periodontal treatment/oral hygiene practice, knowledge about periodontal diseases and its consequences, daily oral hygiene routine, awareness of the current periodontal status and the main reasons for not doing proper brushing and interproximal cleaning. The same researcher who did not included in the clinic process informed the patients about how periodontal diseases develops, its aetiology, symptoms, consequences and the relationship with the important systemic disorders verbally and via brochure as well. The importance of the patients' own efforts about daily cleaning of the mouth were emphasized. Finally oral hygiene instructions, including brushing and flossing, were demonstrated to each patient after nonsurgical periodontal treatment.
15776372|NCT04643236|Behavioral|Oral hygiene motivation session|Standard oral hygiene instructions, including brushing and flossing, were demonstrated to each patient after nonsurgical periodontal treatment.
15776373|NCT04643223|Other|kinesio tape with tension|The application of kinesio tape follows a protocol, which involves the sanitization of the selected scar with liquid soap, drying and application of alcohol to remove sebum. Measurement of the scar and marking of the therapeutic zone and anchors. Following the application of kinesio tape, with tension between seventy to ninety percent on the treated hypertrophic scar. This process follows the routine of patient care established by the service and will continue for a period corresponding to three months. In which, the evaluations of Vancouver, the collections of cicatricial material will be carried out, in the time spaces corresponding to forty-five and ninety days, having as reference the initial evaluation made after being elected.
15776374|NCT04643223|Other|kinesio tape without tension|The application of kinesio tape without tension follows a protocol, which involves the sanitization of the selected scar with liquid soap, drying and application of alcohol to remove sebum. Measurement of the scar and marking of the therapeutic zone and anchors. Following application of the kinesio tape, no tension on the treated hypertrophic scar. This process follows the routine of patient care established by the service and will continue for a period corresponding to three months. In which, the evaluations of Vancouver, the collections of cicatricial material will be carried out, in the time spaces corresponding to forty-five and ninety days, having as reference the initial evaluation made after being elected.
15776375|NCT04643210|Behavioral|F2F MoB EI|"The MoB F2F EI will comprise a total of 12 educational F2F sessions. Each session will have a duration of 1.5 hours and the maximum number of participants in the groups will be 12 patients.
~The intervention group will receive the MoB F2F EI on group or personal form according to the participant's choice. The implementation methodology of the MoB F2F EI will include videos and power point presentations, as well as interactive learning methods such as role-playing, empowerment exercises, live discussions."
15776376|NCT04643210|Other|MoB DP|This is a technology-based intervention, which regards access to a dfigital platform, the MoB DP. The structure of the Digital platform has been partially based on the preferences and needs of the participants (as described in the qualitative part of the study) and its goal is to create an ecosystem where users will be educated and empowered making use of the internet of things (IOT) via a computer, tablet or mobile. The Digital platform will be in the form of a dynamic website with user generated content as well as static information.
15776377|NCT04643197|Device|Barbed PDS suture (STRATAFIX Symmetric PDS Plus)|STRATAFIX Symmetric PDS Plus is a barbed suture.
15776378|NCT04643197|Device|Non-barbed PDS suture (PDS Plus)|Non-barbed suture
15776380|NCT04643171|Device|high intensity elliptical training|30 patients will receive 30 minutes of high intensity interval training on elliptical trainer, 5 times per week, for 12 week
15776381|NCT04643171|Device|electrocaupuncture|30 patients will receive 30 minutes of electroacupuncture on bilateral PC 4 and PC 6 for 5 times per week, for 12 week
15776382|NCT04643158|Drug|AZD1402|Randomised participants will receive oral inhalation of AZD1402, via DPI.
15776383|NCT04643158|Drug|Placebo|Randomised participants will receive oral inhalation of matching placebo via DPI.
15776384|NCT04643158|Drug|Short acting beta agonist (SABA) (rescue medication)|"In addition to study intervention, all participants will be provided with a SABA as rescue medication (eg, salbutamol/albuterol), to be used throughout the Run-in and Treatment Periods. All participants should refrain from taking a SABA as rescue medication 6 hours prior to pulmonary function tests.
~Dosage levels: 100 μg per nominal dose 90 μg per nominal dose pro re nata (as required) (PRN)"
15776385|NCT04643158|Drug|Run-in medications (ICS-LABA combination)|"During the Run-in Period, the participants are required to maintain on their ICS-LABA dose. Controller medications (eg, ICS LABA) should remain at a stable dose and be taken after study intervention as applicable.
~These drugs are used as standard of care."
15776386|NCT04643145|Procedure|Flexible ureteroscopy for renal calculi less than 20 mm|Patients with renal calculi less than 20 mm will be managed by flexible ureteroscopy. at the end of the procedure, they will be randomized to receive either temporary ureteral catheter for 2 days or indweeling double J stent for 2-4 weeks
15776387|NCT04643132|Drug|Normal saline|After the induction of anesthesia, normal saline is intravenously injected in a volume of 2ml, and then a continuous infusion of 20ml/h normal saline until starting skin suture.
15776388|NCT04643132|Drug|S-ketamine (low-dose)|After the induction of anesthesia, S-ketamine is intravenously injected at 0.2mg/kg, and then a continuous infusion of 0.2mg/kg/h S-ketamine until starting skin suture.
15776389|NCT04643132|Drug|S-ketamine (high-dose)|After the induction of anesthesia, S-ketamine is intravenously injected at 0.4mg/kg, and then a continuous infusion of 0.4mg/kg/h S-ketamine until starting skin suture.
15776390|NCT04643119|Device|Medial Congruent Insert|The Medial Congruent Bearing (MC Bearing) design was introduced in 2016 for use with the Zimmer-Persona Cruciate-Retaining Femur: the design facilitates greater stability through increased anterior lip height compared to the original Cruciate Retaining Bearing (CR Bearing), allowing for greater anterior constraint and subluxation resistance that aids in full extension and deep flexion. Furthermore, the MC Bearing has been suggested for use in patients presenting with more complicated surgical histories (e.g prior high tibial osteotomies or patellectomies), whereas the original CR Bearing is strictly suggested for use only in patients undergoing knee surgery for the first time, where the posterior cruciate ligament may still be intact.
15776393|NCT04643106|Procedure|suturing with barbed sutures during laparoscopic ovarian cystectomy|During laparoscopic ovarian cystectomy, suturing of ovarian inner surface will be conducted to stop bleeding
15776394|NCT04643093|Drug|Pitavastatin|Pitavastatin, QD
15776395|NCT04643093|Drug|Ezetimibe|Ezetimibe, QD
15776396|NCT04643093|Drug|1PC111|1PC111, QD
15776397|NCT04643080|Other|Yogurt|6 oz. of a commercially available yogurt were provided daily for 12 weeks
15776398|NCT04643067|Drug|0.15mg KPG-818 dose|The dose levels may be modified according to the results from phase 1b of the study. Dose adjustment is allowed during the study.
15776399|NCT04643067|Drug|0.6mg KPG-818 dose|The dose levels may be modified according to the results from phase 1b of the study. Dose adjustment is allowed during the study.
15776400|NCT04643067|Drug|2mg KPG-818 dose|The dose levels may be modified according to the results from phase 1b of the study. Dose adjustment is allowed during the study.
15776401|NCT04643067|Drug|Placebo|This is the comparative arm.
15776402|NCT04643054|Dietary Supplement|Ovotransferrin|Administering 200 mg of ovotransferrin orally in addition to the standard of care therapy for 10 days
15776403|NCT04643041|Behavioral|watch and wait|patients with DNA mismatch repair-deficient or microsatellite instability-high distal rectal cancer accessed pathological complete response after 6 courses of PD-1 monoclonal antibody (200mg/Course/Q3w) therapy and start watch and wait.
15776404|NCT04643028|Other|Home exercise|Exercise program will include active normal joint movements in the cervical region, postural exercises, strengthening exercises for the scapular retractor muscles, and stretching exercises for the pectoral muscles, levator scapula and upper part of the trapezius and breathing/relaxation exercises.
15776405|NCT04643028|Other|Mulligan mobilization|Mulligan mobilization: Mulligan mobilization will be applied to this group in addition to the exercises in the home exercise group. In painless directions, each session will be applied in 3 sets, a set of 10 repetitions.Sixty seconds of rest will be given between sets.
15776406|NCT04643028|Other|Cervical stabilization|Cervical stabilization group: In addition to the exercises in the home exercise group, this group will be given cervical stabilization training that focuses on the deep neck muscles.
15776407|NCT04643015|Diagnostic Test|MRI|"Briefly, new MRI sequences will be used on a patient who is undergoing a scheduled, clinically necessary MRI exam. Any new research sequence will be scanned in addition to the clinically required sequences and will not interfere with the clinical scan other than requiring five to ten minutes of additional table time. There will be no invasive measures under this protocol."
15776408|NCT04643002|Drug|Isatuximab SAR650984|Pharmaceutical form:Solution for injection Route of administration: intravenous
15776409|NCT04643002|Drug|Dexamethasone|Pharmaceutical form:Tablet Route of administration: Oral
15776410|NCT04643002|Drug|Pomalidomide|Pharmaceutical form:Capsule Route of administration: Oral
15776411|NCT04643002|Drug|SAR439459|Pharmaceutical form:Solution for injection Route of administration: intravenous
15776412|NCT04643002|Drug|Belantamab mafodotin|Pharmaceutical form:Solution for injection Route of administration: intravenous
15776413|NCT04642989|Other|Sham Treatment|All movements of facial effleurage except applying pressure
15776414|NCT04642989|Other|Facial Effleurage|Facial massage to remove any lymphatic blockages
15776415|NCT04642989|Drug|Antibiotics|"Appropriate standard-of-care antibiotics as determined by the physician."
15776416|NCT04642976|Device|Ganglionated Plexi mapping and ablation using Natus Cortical Stimulator and standard ablation catheters|Ganglionated plexi will be mapped using high frequency stimulation with standard ablation catheters attached to a Natus Cortical Stimulator for high frequency stimulation. Vagal innervation to the heart will be assessed with non-invasive Parasym tragal stimulation.
15776417|NCT04642963|Radiation|Cardiac Radiosurgery|Non-invasive delivery of ablative radiotherapy dose to the arrhythmia substrate.
15776418|NCT04642950|Drug|Sargramostim|250 μg/vial of sargramostim will be dissolved in 4 mL of physiological saline and 125 μg of which will be administered using inhaler twice daily in approximately 10-15 minutes.
15776419|NCT04642950|Drug|Placebo|2 mL of physiological saline will be administered using inhaler twice daily in approximately 10-15 minutes.
15776420|NCT04642937|Drug|Treatment with hP1A8|Treatment with hP1A8
15776421|NCT04642924|Drug|SGM-101|Fluorescence-guided surgery
15776422|NCT04642911|Other|Long term follow up|Undergo long term follow up, including copy number measurement safety evaluations diseases specific product (Mesenchymal Stem Cell) in a Ukraine Association of Biobank bio-sponsored clinical trial who agree to participate in this study
15776423|NCT04642898|Behavioral|Standard UP Treatment|Participants will receive treatment modules sequenced in accordance with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al 2011; 2018).
15776424|NCT04642898|Behavioral|Capitalization UP Treatment|Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that capitalize on patient strengths.
15776425|NCT04642898|Behavioral|Compensation UP Treatment|Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that compensate for patient weaknesses.
15776426|NCT04642872|Other|Infant BIT|Not use of unaffected hand containment. Both hand are use to improve the bimanual coordination
15776427|NCT04642872|Other|Infant CIMT/BIT|Use unaffected hand containment in part of the intervention and then, both hands in bimanual activities without containment.
15776428|NCT04642872|Other|Conventional therapy|Following the usual therapy in the baby.
15776429|NCT04642872|Other|infant cimt|use of unaffected hand containment to improve the use of affected hand with unimanual activities
15776430|NCT04642859|Behavioral|Computerized Cognitive abilities training battery for reading (CATB-R)|Specially designed Arabic computerized training program for dyslexia
15776431|NCT04642846|Other|Silver Diamine Fluoride (SDF)|Silver diamine fluoride (SDF) is one of the topical methods for caries arresting. The advantages of using SDF include ease of use, low cost, pain and infection control, minimal requirement of time/training and non-invasive nature of the procedure. SDF can improve oral health, increase access to care and reduce the need for emergency treatment
15776432|NCT04642820|Drug|Methamphetamine|Participants will be given 20 mg of Methamphetamine.
15776505|NCT04642261|Drug|Empagliflozin 10 MG|Empagliflozin 10mg daily
15776434|NCT04642807|Procedure|Long arm soft cast|Participants in group 2 will have a long arm soft cast applied without clinical or radiological follow up.
15776435|NCT04642807|Procedure|Long arm full cast|Participants in group 1 will have a long arm full cast applied.
15776436|NCT04642794|Other|observational study|patients admitted for AP with portosplenomesenteric vein thrombosis.
15776437|NCT04642781|Diagnostic Test|reading of a text|Reading of 2 IRest Texts presented on a laptop in randomized order while eye movements are recorded with a tracking bar.
15776438|NCT04642768|Dietary Supplement|KetoneAid Ketone Ester|Commercially available ketone supplement
15776439|NCT04642768|Dietary Supplement|Maltodextrin|Commercially available maltodextrin supplement
15776440|NCT04642742|Dietary Supplement|Chewable plant sterol|Chewable plant sterol (gummy)
15776441|NCT04642729|Procedure|Fresh Corneal Lenticule Implantation using Relex-Smile Surgery|Knowing that the most important element is damage of stroma we used all preoperative procedures atlas, optic tomography and especially electron microscope. Approximately we planned how much microns we remove and insert, for example we remove 80 µm and we insert fresh corneal lenticule 90 µm with the purpose to remove more dead keratocytes which increase biomechanical instability of corneal metabolism (abnormal increase collagenase activity, decrease proteinase inhibitors, excessive premature keratocyte apoptosis, increase cytokine binding). Fresh Corneal Lenticule and autologous serum contains live stem cells that produce keratocytes, collagen fibers, extracellular matrix which contribute to the regeneration of the cornea, and all this results at increasing of corneal transparency and visual acuity in patients with corneal macular dystrophy.
15776442|NCT04642716|Other|Saliva collection of patients and salivary free amino acids analysis|
15776443|NCT04642677|Other|healthcare provider's recommended communication with sympathy and printed paper|"Patients and caregivers were received healthcare provider's recommended communication with sympathy and printed paper, Regardless of the patient's outward consciousness, talk with the patient and express empathy. Hearing will be maintained until the end. three times a day (8, 14 and 20 o'clock) during palliative sedation."
15776444|NCT04642664|Drug|Apatinib plus Camrelizumab|Patients received apatinib orally at 250 mg once a day irrespective of the patient weight. During the treatment, apatinib can reduced to half of piece or once every other day considering the grade of treatment related adverse events. Camrelizumab 200 mg was administered intravenously over 30 minutes every 3 weeks. The intermittent period of camrelizumab was no longer than 6 weeks. All patients continued combination treatment until disease progression, unacceptable toxicity, or discontinuation for any reason.
15776445|NCT04642651|Drug|Dexmedetomidine|Patients in the dexmedetomidine group receive single-shot femoral nerve block preoperatively using a mixture of 0.375% ropivacaine and 1.0 μg/kg dexmedetomidine, in a total volume of 20 ml.
15776446|NCT04642651|Drug|Placebo|Patients in the control group receive single-shot femoral nerve block preoperatively using a mixture of 0.375% ropivacaine and normal saline, in a total volume of 20 ml.
15776451|NCT04642625|Other|Visual Analog Score|"The VAS is a widely used tool in research and clinical practice, and its reliability and validity in pain assessment has been clearly demonstrated. It consists of a 100 mm line. 0 cm no pain, 10 cm is associated with 'worst possible pain'. The patient is asked to mark the line to 'score' the pain. VAS values of 1cm - 3cm weak, 4cm - 6cm moderate, and >7cm are the indicators of severe pain."
15776452|NCT04642625|Other|patient satisfaction|The patient's satisfaction with postoperative pain treatment will be recorded. 4 options; excellent, good, medium and bad.
15776453|NCT04642612|Device|TCD Measurement|"CBFV measurements will be acquired continuously with the patient supine and the head neutral. Analysis of CBFV measurements will be undertaken at 3 timepoints:
~Patient awake and supine in the holding area
~After sedation
~After interscalene nerve block"
15776454|NCT04642599|Device|Bimanual motor skill learning with the REAplan® rehabilitation robot|REAplan® rehabilitation robot: training to perform complex, coordinated, bimanual movements
15776455|NCT04642586|Diagnostic Test|multimodal magnetic resonance imaging|Brain MRI exam (without contrast injection)
15776456|NCT04642586|Diagnostic Test|blood test|Blood test to evaluate cardiovascular risk factors (cholesterol, triglycerides, LDL and HDL-CT, serum creatinine, fasting glucose, serum potassium), .
15776457|NCT04642586|Diagnostic Test|neuropsychological assessment|neuropsychological assessment
15776458|NCT04642573|Other|non interventional|non interventional
15776459|NCT04642547|Drug|Lenvatinib and Gefitinib|"First week: Gefitinib: 125mg/day, oral; Lenvatinib: 8mg/day (weight ≤ 60Kg) or 12mg/day (weight > 60Kg), oral.
~One week later: Gefitinib: 250mg/day, oral; Lenvatinib: 8mg/day (weight ≤ 60Kg) or 12mg/day (weight > 60Kg), oral."
15776460|NCT04642521|Device|Jamar hydraulic hand dynamometer|"The strength of the dominant hand will be recorded before and after receiving intravenous iron.
~Each participant will be positioned in a straight back chair with both hand and feet flat on the ground, elbow flexed to 90 degrees with forearm and wrist in the neutral position. Patient's muscle strength will then be tested three times with an interval of one minute between testing and the average of three times will be recorded to the nearest 0.1kg."
15776461|NCT04642508|Procedure|Prepectoral reconstruction|Immediate prepectoral breast reconstruction in women requiring a mastectomy
15776462|NCT04642495|Diagnostic Test|"Visual acuity testing with SW , Landolt-C and Tumbling-E symbols"|Establish prediction intervals for acuity tests
15776463|NCT04642482|Dietary Supplement|Synbiotic (Rillus)|Participants in this group will be given a fine powder of synbiotic formula and should be taken orally without diluted with water.
15776464|NCT04642482|Drug|Placebo|Participants in this group will be given a fine powder of maltodextrin formula and should be taken orally without diluted with water.
15776506|NCT04642261|Drug|Placebo pills|Identical in appearance to empagliflozin 10mg daily
15776467|NCT04642456|Diagnostic Test|Balance Assessment Scale|The newly developed balance, based on the Balance Evaluation Systems Test (BESTest) and Trunk Control Measurement Scale (TCMS), will be administered by two raters (normative and clinical database + interrater reliability)
15776468|NCT04642456|Diagnostic Test|Trunk strength measurement with EMG|A trunk strength protocol in sitting position, using a hand-held dynamometer is developed. During the trunk strength measurements muscle activity of certain muscles of the trunk will be measured using surface electromyography (EMG)
15776469|NCT04642456|Diagnostic Test|MRI spine/pelvis|We will be capturing 3D MR images of the subject lying supine with extended knees, using a T1 weighted SE sequence with interslice distance 3 mm in the area of the hip) extended with full spine MRI images (sagittal full spine T1- and T2- weigthed images as part of the standard sagittal view of full spine to check for significant stenosis or spinal cord pathology) and additional T1-weighted axial slices at level L4, T12 and T8 with interslice distance 4 mm.The field of view covers the full spine, pelvis and hip smaller trochanter.
15776470|NCT04642456|Diagnostic Test|EOS stereoradiographic full body exam|Every subject included in the study will undergo a stereoradiographic full body EOS exam completed with Gravity Line (GL) location, recorded by a force plate on the floor
15776471|NCT04642456|Diagnostic Test|Balance Assessment Scale 2|Repeating the newly developed balance test (test-retest reliability) within 2 weeks after first measurement
15776472|NCT04642456|Diagnostic Test|Trunk strength measurement with EMG 2|Repeating the trunk strength protocol with EMG within 2 weeks after the first measurement (test-retest reliability)
15776473|NCT04642443|Device|SENSE Device|The SENSE Device is indicated for the monitoring of intracranial hemorrhage by detecting a suspected increase in blood volume within the cranial vault. It is an adjunctive device to the clinical evaluation in the acute hospital setting of patients 22 years of age or older with suspected or known intracranial hemorrhage. The device is indicated for use to monitor patients for intracranial hemorrhage expansion between CT scans but should not serve as a substitute for these scans.
15776474|NCT04642430|Drug|Apixaban|Refer to Apixaban group
15776475|NCT04642430|Drug|Rivaroxaban|Refer to Rivaroxaban group
15776476|NCT04642417|Other|dietary fiber literacy|education
15776477|NCT04642417|Other|routine care|routine care
15776478|NCT04642404|Drug|Epidiolex 100 mg/mL Oral Solution|Cannabidiol (CBD): is the primary non-psychoactive and non-addictive compound in cannabis, has already shown potential in treating pain such as arthritis, neuropathic, cancer and chronic pain
15776479|NCT04642404|Drug|Placebo|Placebo drug will be a solution with the same taste, texture and color as the drug.
15776480|NCT04642391|Drug|Cosyntropin|Administer 0.25mg Cosyntropin to determine adrenal sufficiency vs. insufficiency in patients with decompensated cirrhosis
15776481|NCT04642378|Drug|iNCDSS based insulin regime|Patients of this group will receive the insulin regime set by the AI assisted insulin titration system (iNCDSS).
15776482|NCT04642378|Drug|routine insulin treatment regime|Patients of this group will receive the insulin regime recommended by professional endocrinologists.
15776483|NCT04642365|Drug|RO7296682|RO7296682 will be administered as per the schedules specified in the respective arms.
15776484|NCT04642365|Drug|Atezolizumab|Atezolizumab will be administered as per the schedules specified in the respective arms.
15776485|NCT04642352|Drug|superior laryngeal nerve block|A unilateral injection of 2 cc of a 1:1 mixture of 0.25% bupivacaine and Kenalog-40 via a 27 gauge needle to the thyrohyoid space (front of neck, just above larynx/voice box) via a 27 gauge needle to the thyrohyoid space (front of neck, just above larynx/voice box) on the side which exhibited most discomfort/tenderness/cough on palpation. If neither side was uncomfortable, the right side will be used.
15776486|NCT04642339|Biological|Gam-COVID-Vac|Gam-COVID-Vac combined vector vaccine, 0,5ml/dose+0,5 ml/dose prime-boost immunization with component I (rAd26-S) and component II (rAd5-S) with 21 days interval
15776487|NCT04642339|Biological|Placebo|Placebo
15776488|NCT04642326|Device|Test Group: experimental - UVC Therapy applied|in addition to traditional drug therapy, apply a surgical treatment procedures with using special UVC device.(Antiviral + Antimalarial + Antibiotic Treatment + UVC Therapy)
15776489|NCT04642313|Other|Magnesium and/ or Potassium|Magnesium and/ or potassium supplements will be provided to patients of diabetes mellitus with insomnia
15776490|NCT04642300|Procedure|Holmich Protocol|"Module 1 (1st two weeks):
~i)Isometric adduction ii)Abdominal sit-ups iii)Isometric adduction iv)Compound abdominal sit-ups and hip flexion v)Balance exercise on wobble board vi)One-foot exercise on sliding board
~Module 2 (from 3rd week):
~i)Leg abduction and adduction exercise carried out in side lying ii)Low back extension exercise prone on the end of bench iii)One leg weight pulling abduction/adduction standing iv)Abdominal sit ups v)One leg coordination exercise vi)Training in sideways motion vii)Balance exercise on wobble board"
15776491|NCT04642300|Procedure|Myofascial Release Technique|"Transverse friction massage: 10 mins on painful area of adductor-tendon insertion into pubic bone
~Stretching of adductor muscles, hamstrings muscles and hip flexors:3 times and each stretch is 30s with Contract relax technique"
15776492|NCT04642287|Drug|Calcipotriol Only Product in Cutaneous Dose Form|Calcipotriene is a form of vitamin D. It works by inducing thymic stromal lymphopoietin cytokine expression in the skin.
15776493|NCT04642287|Drug|Vaseline|Placebo
15776494|NCT04642287|Drug|Topical 5FU|5-FU is a chemotherapy that causes the death of proliferating tumor cells. Topical preparation of this drug is being used.
15776495|NCT04642274|Other|Nutrition|Correct the patient's low nutritional status before surgery.
15776496|NCT04642274|Other|Control Blood Glucose|Control the patient's blood glucose before surgery, fasting blood glucose level ≤ 8mmol/L or HbA1c ≤ 7%.
15776497|NCT04642274|Drug|Fasting|Take 10% glucose water 6ml/kg 2 to 4 hours before operation (except for diabetes).
15776498|NCT04642274|Behavioral|Smoking and Alcohol|Quit smoking and alcohol before surgery
15776499|NCT04642274|Other|Control Anemia|Correct anemia before surgery
15776500|NCT04642274|Other|Blood Transfusion|Use strict blood transfusion indications and blood protection strategy during surgery.
15776501|NCT04642274|Other|GDFT|Use goal-directed fluid therapy during surgery.
15776502|NCT04642274|Other|Remove the tracheal tube|Remove the tracheal tube as soon as possible after surgery.
15776503|NCT04642274|Behavioral|Eating and Drinking|Eat and drink as soon as possible after extubation after surgery.
15847561|NCT04062305|Other|Questionnaire Administration|Ancillary studies
15776507|NCT04642248|Other|Personalized Run Practice|A combination of drills, flexibility, and strength activities combined with a gait retraining program
15776508|NCT04642235|Other|Nature Nook|The Nature Nook intervention will take place on lots that already have the standard greening intervention. In addition, design elements will be added such as a simple path and benches to explicitly invite people into the space. An additional difference is the exclusive use of larger, corner lots, rather than smaller mid-block spaces, to maximize visibility.
15776509|NCT04642235|Behavioral|Nature Coach|"The Nature Coach Intervention consists of 3 components - home visit, text message follow up, and goal feedback.
~Home visit. During the 1-hour home visit, the coach will (a) provide education about the health benefits of nature, (b) identify nearby nature targets for the participant to visit, (c) complete a pre-commitment contract based on individualized weekly nature goals, and (d) brainstorm barriers and solutions to reaching the goals.
~Personalized weekly text messages. Texts will serve as reminders of goals set with the Nature Coach, as well as encouragement to meet the goals. The context of text messages with change slightly based on individual participants, the goals they set, and the barriers they identify.
~Goal feedback- At the end of each week, participants will receive a progression badge via text message that shows the amount of days and time they spent in nature, and how this matched up to the goal set with the Nature Coach."
15776510|NCT04642235|Other|Nature Nook + Nature Coach|The combined intervention will involve the installation of Nature Nooks to blighted vacant lots followed by the delivery of the Nature Coach intervention to people living in the immediate surrounding blocks. The intervention will be tailored to explicitly direct participants to use the Nature Nook.
15776511|NCT04642222|Behavioral|APOLO-Teens web-based intervention|The APOLO-Teens web-based intervention is a 6-month cognitive-behavioral lifestyle program developed to optimize treatment as usual for pediatric obesity in public portuguese hospitals.
15776512|NCT04642222|Other|Treatment as Usual for Pediatric Obesity|Treatment as Usual for pediatric obesity in portuguese public hospitals.
15776513|NCT04642209|Device|Aggregometry|"After evaluation at the Emergency Department the anesthesiologist immediately collects a sample of blood for TEG with ADP Platelet Mapping test.
~If both MA-ADP and platelets aggregation (%) are within normal values (i.e. ≥45 mm and ≥83%, respectively), the patient could be considered as candidate for immediate surgery (within 48 hours) with neuraxial anesthesia.
~If MA-ADP and/or platelets aggregation (%) are lower than normal values, the Nottingham Hip Fracture Score (NHFS) is computed, to predict the 30-day mortality after hip fracture surgery. If NHFS is ≥4 (high risk), the patient will undergo to general anesthesia and peripheral antalgic block, to perform surgery within 48 hours. In case of low risk for mortality (i.e. a NHFS <4), surgery will be postponed until the normalization of both MA-ADP and platelet aggregation."
15776514|NCT04642157|Other|ELIOS|"ELIOS is a suicide prevention system worldwide entirely tailored to the AYA contemporaneous modes of interaction on social media.
~This includes
~A systematic initial contact with an ELIOS web-clinician
~Systematic recontacts by the ELIOS web-clinicians scheduled at 24h, 72h and/or 7 days, depending on the participants' level of suicide risk
~The opportunity to spontaneously contact the ELIOS system and get in contact with a web-clinician"
15776515|NCT04642157|Other|other resources contacts|"Three types of resources will be suggested via the ELIOS website:
~The General Practitioner (GP)
~The closest medico-psychologic center (CMP)
~The emergency services The order of presentation of the resource contacts will depend on the participants' intensity of suicidal ideation."
15776516|NCT04642144|Other|Yerba mate infusion|"Yerba mate infusion intervention is characterized by the consumption of the infusion of yerba mate for 7 days preceding the test, with consumption of the infusion right before the exercise protocol test, without consumption of a carbohydrate-based meal, keeping the individual fasted.
~Yerba mate and carbohydrate intervention is characterized by the consumption of the infusion of yerba mate for 7 days preceding the test, with consumption of a meal based on carbohydrate right before the exercise protocol test with another infusion of yerba mate."
15776517|NCT04642144|Other|Carbohydrate meal|Carbohydrate meal intervention is characterized by the consumption of a carbohydrate-based meal right before the exercise protocol test, without consumption yerba mate infusion.
15776518|NCT04642131|Dietary Supplement|Caffeine supplementation|Participants will wear standard insoles and ingest caffeine in liquid form (3mg/kg) with carbohydrates.
15776519|NCT04642131|Device|Personalized insoles|Participants will wear personalized insoles and ingest a drink of carbohydrates without caffeine
15776520|NCT04642131|Other|Control condition|Participants will wear standard insoles and ingest a drink of carbohydrates without caffeine
15776521|NCT04642118|Procedure|Pulmonary recruitment maneuver|Using setting pressure form ventilator to increase pulmonary pressure by compress balloon bag 5 times, 5 seconds per time
15776522|NCT04642105|Device|Sensor-Dot and Plug 'n Patch system|We will use a small, unobtrusive wearable (Sensor-Dot) to measure different biosignals (EEG, ECG, EMG, motion, skin temperature, respiration and oxygen saturation) for up to one year using newly developed skin adhesives and patches (Plug 'n Patch system)
15776523|NCT04642092|Behavioral|PsicAP protocol|The intervention will include: psychoeducation, relaxation and breathing techniques, thought management, tips to improve quality of life and relapse prevention. All of these activities will be based on scientific evidence and many of these aspects will be supported by mobile devices.
15776524|NCT04642092|Behavioral|Conventional treatment|Typical treatment that is currently given to patients with emotional disorders in Dominican primary care units.
15776526|NCT04642066|Other|Cold water immersion|Full body CWI in open standing, except the head (same location, timing), frequency three times a week in the duration of 7-10 minutes. Swimming was permitted. Volunteers must not use neoprene aids (gloves, shoes), caps were allowed. Volunteers should be in the final phase submerged in water, above which there should only be the head and neck. The upper limbs were below the water surface. Non-neoprene footwear was permitted. Volunteers entered the water continuously without stopping. The time of stay in water was calculated from the first contact of the foot with water. On average, the whole body needed to be immersed in water within 30 seconds.
15776527|NCT04642066|Other|No cold water immersion|People without cold water immersion
15776577|NCT04641572|Other|Choose comfortable position|Standing or walking, Squatting, Sitting, Hands /knees, and Kneeling, positions will be taken by the participant during labor.Then the researcher will register the time ( minutes/hours) will be taken and which that will be more preferable by the participant
15776528|NCT04642053|Behavioral|Dynamic Temporal and Tactile Cuing|Dynamic Temporal and Tactile Cuing is based on principles of integral stimulation where the client watches, listens to and imitates the clinician (Strand, 2020). Treatment will begin by training the child to imitate and simultaneously produce syllables/words with the clinician. Sessions will focus on establishing accurate movement transitions in treated words. The child will be asked to imitate the clinician's production of the target. If the child's imitation is inaccurate, they will be instructed to simultaneously produce the target with the clinician. Simultaneous productions will continue to provide practice opportunity with maximal cuing. As the child gains greater accuracy, simultaneous productions will be faded and direct imitation will be attempted again. Over the course of treatment, the movement gesture will be shaped with the goal being accurate production with normal rate and naturalness.
15776529|NCT04642040|Other|Pulmonary Rehabilitation|Positioning,breathing techniques (diaphragmatic breathing, alternate breathing, and pursed-lip breathing),respiratory muscle exercises, joint ROM exercises, early-mobilization and progressive ambulation, peripheral muscle strengthening exercises
15776530|NCT04642027|Radiation|Conventional sEBRT|A total dose of70 Gy in 35 daily fractions of 2 Gy during 7 weeks
15776531|NCT04642027|Radiation|Hypofractionated sEBRT|A total dose of 60 Gy in 20 daily fractions of 3 Gy during 4 weeks
15776532|NCT04642014|Biological|COVID-19 convalescent plasma treatment|"The donor's blood will be collected after four weeks post-onset of illness. 600 ml ABO-compatible plasma sample will be harvested during apheresis from each donor and each sample will be divided and stored as 200 mL aliquots.
~Patients who meet the criteria receive one dose (200 mL) of ABO compatible inactivated convalescent plasma with a confirmed neutralization activity."
15776533|NCT04642001|Other|Photon Laser III-DMC (without radiation emission) + My First- Colgate|Positioning of the FBM (Photon Laser III / DMC) without emitting radiation, the equipment's sound was mimicked with the Beep application (Foncannon Inc, Google, © 2018), followed by the use of fluoride-free toothpaste (My First- Colgate) and brushing three times a day.
15776534|NCT04642001|Other|Photon Laser III-DMC (without radiation emission) + Sensodyne® Rapid Relief / GSK|Positioning of FBM (Photon Laser III / DMC) without emitting radiation, the equipment's sound was mimicked with the Beep application (Foncannon Inc, Google, © 2018), followed by the application of toothpaste containing strontium acetate (Sensodyne® Rapid Relief / GSK) and brushing three times a day.
15776535|NCT04642001|Radiation|Photon Laser III-DMC (with irradiation emission) + My First- Colgate|Emission of FBM therapy (Photon Laser III / DMC), followed by the use of fluoride-free toothpaste (My First- Colgate) and brushing three times a day.
15776536|NCT04642001|Combination Product|Photon Laser III-DMC (with irradiation emission) +Sensodyne® Rapid Relief / GSK|Emission of FBM therapy (Photon Laser III / DMC), followed by the application of toothpaste containing strontium acetate (Sensodyne® Rapid Relief / GSK) and brushing three times a day.
15776537|NCT04641975|Drug|Mirabegron|Oral/ Oral Suspension: Participants with a body weight of ≥ 35 kg are to receive the tablet form of IP unless unable to swallow tablets and will be provided the oral suspension as an alternative. Participants with a body weight < 35 kg or those who cannot be dosed with the tablet will receive oral suspension.
15776538|NCT04641975|Drug|Placebo|Oral/ Oral Suspension
15776541|NCT04641949|Procedure|Lower body negative pressure (LBNP)|LBNP is a model of experimental hypovolemia, whereby the lower body is exposed to negative pressure leading to sequestering of blood in the lower body and central hypovolemia. LBNP will be induced stepwise with increments of 10 mmHg, each level lasting 1 min. LBNP will be terminated at symptoms or signs of impending hemodynamic collapse.
15776542|NCT04641936|Other|No intervention required|No intervention required
15776543|NCT04641923|Other|Adhesion barrier|Adhesion barrier application at the time of first surgery
15776544|NCT04641910|Other|No intervention|No intervention
15776545|NCT04641897|Procedure|Respiratory rate modification|"During the Low RR and High RR periods, respiratory rate will be set depending on baseline ABG and according a nomogram so as to have an approximate difference of 10 points between groups, while maintining PaCO2 and pH values within safety limits (pH 7.20 to 7.45, and PaCO2 35 to 60 mmHg).
~Once defined the target respiratory rate, this will be decreased or increased in 4 points each 30 to 45 min, and ABG repeated at 2 hours. At this time, changes will be made to keep PaCO2 and pH values within safety limits, and ABG repeated at 6 and finally 12 hours.
~During the whole period, inspiratory to expiratory ratio will be maintained constant, and only changed to keep inspiratory time above 0.6 seconds (usually at high resp rate)."
15776546|NCT04641884|Other|Not concerned|Not concerned
15776547|NCT04641871|Drug|Sym021|IV infusion over 30 minutes on day 1 and 15 of each cycle.
15776548|NCT04641871|Drug|Sym022|IV infusion over 30 minutes on day 1 and 15 of each cycle.
15776549|NCT04641871|Drug|Sym023|IV infusion over 30 minutes on day 1 and 15 of each cycle.
15776550|NCT04641871|Drug|Irinotecan Hydrochloride|IV infusion over 90 min on day 1 and 15 of the first 2 cycles. After 2 cycles of treatment, irinotecan may be discontinued at the Investigator's discretion
15776551|NCT04641858|Biological|BCG-Denmark|Participants randomized to receive BCG will receive one 0.1 ml dose of Mycobacterium bovis BCG live attenuated BCG-Denmark vaccine (AJ Vaccines, Copenhagen, Denmark) by intradermal injection in the left deltoid region.
15776552|NCT04641858|Biological|Saline|Participants randomized to the control group will receive one 0.1 ml dose sterile 0.9 % NaCl by intradermal injection in the right deltoid region.
15776553|NCT04641845|Other|Cork inlay wedge|
15776554|NCT04641832|Other|Soccer heading|A standardized and reliable soccer heading protocol will be used for the experiment. A triaxial accelerometer embedded in a head-band pocket and positioned directly below the external occipital protuberance (inion) to monitor linear and rotational head accelerations. A JUGS soccer machine will be used to simulate a soccer throw-in with a standardized ball speed of 25mph. The ball speed is similar to when soccer players make a long throw-in from the sideline to mid-field. Soccer players frequently perform this maneuver during practice and games. Subjects will stand approximately 40ft away from the machine to perform the heading. Participants perform 20 standing headers with 1 header per 30 seconds. The subjects will be instructed to direct the ball back toward the JUGS soccer machine in the air.
15776708|NCT04640480|Drug|SNB-101|SN-38 dosage ranges from 1 to 6 will be determined by Safety Review Committee meeting
15778144|NCT04628884|Drug|Conventional dose|Conventional dose used to calculated the protamine dose
15776555|NCT04641819|Drug|Yangzheng Compound Mixture|"At the end of the treatment period, the investigator can decide whether to continue the medication based on the improvement of the subjects' sleep disturbance.
~Medication during the follow-up period: subjects will enter the follow-up period after completing one course of Yangzheng Compound Mixture treatment or the end of the treatment period. Visits will be conducted once every 3 weeks, at least 2 times and no more than 4 times. For subjects in the experimental group, doctors can decide whether the patients should continue to receive Yangzheng Compound Mixture therapy in the follow-up period according to the improvement of sleep disorders, while for subjects in the control group, the patients can choose to start receiving Yangzheng Compound Mixture therapy in the follow-up period according to their own wishes and doctors' suggestions."
15776556|NCT04641819|Other|Conventional Treatment|Including treatment of sleep disorders and tumor which shall follow the clinical guidelines.
15776557|NCT04641793|Device|Motion and Emg Control|"We will consider two methods for integrating motions and EMG signals:
~Direct methods. Signals extracted from the latent EMG space will directly contribute to the control of the external device. We will integrate EMG and IMU in two ways. In a first scenario, EMG and IMU will be given variable weight in the control. In a second scenario (perturbative method) the distance of ongoing muscle patterns from a desired set of strategies will modulate the mapping from body to cursor motions in the form of assistive (i.e. the cursor moves faster towards the target) or resistive (i.e. the cursor slows down) influences on cursor movement.
~Indirect Methods. Signals extracted by EMG will modulate the feedback offered to the learner to penalize deviations from desired muscle patterns. When multiple ways to perform a movement are offered by redundancy, (i.e., by the multiplicity of muscles compared to task demands), the brain chooses solutions that minimize noise and uncertainty."
15776558|NCT04641780|Drug|Brexpiprazole|"For the treatment of schizophrenia, the recommended starting dosage for Rexulti™ is 1 mg once daily on Days 1 to 4, taken orally with or without food. The recommended target Rexulti™ dosage is 2 mg to 4 mg once daily. Titrate to 2 mg once daily on Day 5 through Day 7, then to 4 mg on Day 8 based on the patient's clinical response and tolerability. The maximum recommended daily dosage is 4 mg.
~The recommended starting dosage for Rexulti™ as adjunctive therapy for MDD is 0.5 mg or 1 mg once daily, taken orally with or without food. Titrate to 1 mg once daily, then up to the target dosage of 2 mg once daily. Dosage increases should occur at weekly intervals based on the patient's clinical response and tolerability. The maximum recommended daily dosage is 3 mg. It must be periodically reassess to determine the continued need and appropriate dosage for treatment."
15776559|NCT04641754|Drug|WX-0593 Tablets|tablets, 60 mg→180mg, quaque die（QD）
15776560|NCT04641741|Drug|Mepolizumab 100 MG|Discovery of predictive/prognostic biomarkers of response to mepolizumab using flow cytometry, transcriptomic, and proteomic technologies.
15776561|NCT04641728|Drug|Pembrolizumab|pembrolizumab 200 mg every three weeks (Q3W)
15776562|NCT04641728|Drug|Olaparib|olaparib 300 mg twice daily (BID)
15776563|NCT04641715|Procedure|OAGB-MGB|One Anastomosis Gastric Bypass - Mini Gastric Bypass as both restrictive and malabsorptive bariatric procedure
15776564|NCT04641702|Drug|Atropine challenge|Atropine challenge. After baseline FLIP, subjects will be administered 15 mcg/kg of intravenous atropine. Two minutes after administration, FLIP will be repeated.
15776565|NCT04641702|Procedure|Esophageal muscle biopsy|Esophageal muscle biopsy. During standard-of-care Heller myotomy or per-oral endoscopic myotomy, 5mm of lower esophageal sphincter and distal esophageal circular muscle will be collected via biopsy forceps.
15776566|NCT04641689|Device|Desk Only|Provision of height-adjustable desk
15776567|NCT04641689|Behavioral|Program Only|Online modules will promote goal setting, self-monitoring, habit formation, social support, barrier identification, and environmental modifications
15776568|NCT04641676|Diagnostic Test|NGS testing|NGS test will be performed
15776569|NCT04641663|Dietary Supplement|Multi-target Dietary Supplement (MTDS)|"The Multi-Target Dietary Supplement (MTDS) is comprised of 51 ingredients designed to simultaneously target and support the cellular processes implicated in the progression of the aging phenotype (oxidative stress, inflammatory processes, insulin resistance, and membrane and mitochondrial deterioration). The MTDS is unique in that it was specifically designed as a multi-target intervention to support the complex cellular perturbations associated with aging. Components of the formulation were chosen based on scientific consensus of documented effectiveness for one or more of the targeted processes, long-term evidence of safety, and synergistic or additive interactions between components.
~The MTDS is divided into morning and evening doses to maximize availability of the components to the peak activity level of the cellular processes that require those components."
15776570|NCT04641637|Procedure|TACE|Through a 7 French sheath placed through a single femoral arterial puncture, a guide catheter (Cobra 1 Guide Catheter, Mach 1, Boston Scientific Corporation, Marlborough, USA) is placed at the coeliac axis. From the digital subtraction angiography (DSA), the number of arterial tumor feeders to the HCC is identified. One or more feeder(s) is to be catheterized for delivery of therapeutic agent using a 2.4 French microcatheter (Merit Maestro, Merit Medical Systems, Utah, USA), and the other feeder(s) is occluded with a balloon catheter using 0.1 to 0.2mL diluted contrast for inflation (4mm x 10mm Temporary Occlusion Balloon Catheter, Occlusafe, Terumo Clinial Supply, Gifu, Japan). The occlusion target could be a feeder or a common trunk leading to a number of feeders. The therapeutic agent was delivered under fluoroscopic control until the vasculature of the whole tumors is entirely filled, which was assessed with DSA and non-contrast CT performed at the completion of the procedure.
15776571|NCT04641624|Other|ultrasound assessment|soluble fms-like tyrosine kinase-1, proangiogenic protein placental growth factor, and niacin measurementswith a commercially available enzyme-linked immunosorbent assay (ELISA) kit.
15776572|NCT04641611|Other|Bicaval cannulation|Cannulation of SVC and IVC through right atrium in patients undergoing CABG. with snares applied
15776573|NCT04641611|Other|Cavoatrial cannulation|Cannulating the right atrium and Inferior vena cava with a 2-stage cannula
15776574|NCT04641598|Procedure|Endometrial Scratch|"An endometrial biopsy pipelle will be used to create endometrial injury in the form of a scratch."
15776575|NCT04641598|Procedure|Sham procedure|Motions of performing an endometrial scratch will be performed including speculum placement and cervix cleansing, however, placement of the tenaculum and the endometrial scratch will not be performed.
15776576|NCT04641585|Diagnostic Test|Patients affected by Brugada Syndrome 1|ECG analysis by Machine Learning algorithms and blood collection for the transcriptomic study of markers possibly associated with the disease
15776578|NCT04641559|Other|Personalized nutrition group|"A digital environment which combines biological information, personal habits and preference to provide nutritional recommendations. This digital environment is composed by the follow softwares:1. The recommender system: software that combine the behavioral and biological information about the volunteer and generates personalized nutritional recommendations; 2. The ALDI microsite: A microsite that retrieves the personalized recommendations for the volunteer from the recommender system. The ALDI microsite matches food categories with products of the ALDI catalogue. As a result, the volunteer receives a list of products classified under different food categories that are recommended for him/her. Next to each food category, the number of servings recommended (weekly or daily) is also shown.
~The ALDI microsite is a tool only to elaborate a shopping list through personalized recommendations. Therefore, volunteers can choose to buy their food shopping list at wherever store other from ALDI."
15776579|NCT04641559|Other|Personalized Plan group|Participants will use the same software described in for the Personalized nutrition group together with a behavioral change program designed to increase the adherence to the recommendations provided by the ALDI microsite by promoting a proper attitude by means of a series of personalized, goal-orientated, friendly, achievable actions delivered periodically to the volunteer. The behavioral change program will be fed with the results of behavior questionnaires. The personalized messages will be delivered through the ALDI microsite. These personalized messages will be available only for those subjects engaged in the Personalized Plan group.
15776580|NCT04641559|Other|Control group|The participants in the control group will not have personalized recommendations. These participants will have access to a restricted version of the ALDI microsite where the list of recommended products correspond to categories that are general recommendations according to Mediterranean diet.
15776581|NCT04641546|Procedure|Therapeutic Exercise|Passive range of motion (PROM), active-assistive range of motion (AAROM), active range of motion (AROM), and strengthening activities.
15776582|NCT04641546|Procedure|Occupation-Based Intervention|Collecting and placing items in cabinets, washing windows and tables, and hanging clothes on a clothesline.
15776583|NCT04641533|Procedure|L-PRF + DPSC|After surgical removal of impacted mandibular third molars, extraction sockets were filled with L-PRF membranes + DPSCs.
15776584|NCT04641533|Procedure|L-PRF|After surgical removal of impacted contralateral mandibular third molars, each extraction sockets were only filled with L-PRF membranes.
15776585|NCT04641520|Other|Shoulder clinical testing with isokinetic strength assessment|All the participants had a shoulder clinical testing including shoulder rotators range of motion and isokinetic rotator muscle strength testing
15776586|NCT04641507|Drug|Tadalafil versus tamsulosin as MET|166 patients with lower ureteric stone will be randomaized using computer-based randomization charts equally into 83 patients (Group A) treatment with tamsulosin 0.4 mg once daily or 83 patients (Group B) treatment with tadalafil 10 mg once daily. Therapy will be given for a maximum of 4 weeks.
15776587|NCT04641494|Dietary Supplement|Conjugated linoleic acid|CLA Mixture capsule (50:50, c9, t11-CLA: t10, c12-CLA)
15776588|NCT04641494|Dietary Supplement|High oleic acid safflower oil capsules|
15776589|NCT04641481|Biological|BBV152|BBV152 (6µg-Algel - Imidazoquinoline)
15776590|NCT04641481|Biological|Placebo|Placebo (PBS+Alum, without antigen)
15776591|NCT04641468|Procedure|DCB|OCT technical guidance: if B-type or C-type dissection can be seen, Oct should be used for further evaluation, and des treatment should be conducted if necessary
15776592|NCT04641455|Drug|Espumisan, N acetylcystein|Administration of mucolytic solution before upper endoscopy (Espumisan 320 mg, ACC long 600 mg)
15776593|NCT04641455|Drug|Espumisan, N acetylcystein|Administration of mucolytic solution before upper endoscopy (Espumisan 20 mg, ACC long 200 mg)
15776594|NCT04641455|Drug|Water|Administration of water before upper endoscopy
15776595|NCT04641442|Biological|MAS825|Experimental drug
15776596|NCT04641442|Biological|Placebo|matching placebo
15776597|NCT04641429|Behavioral|Qigong exercise|Participants in the experimental group receive 12-week group-based Qigong exercise training.
15776598|NCT04641429|Behavioral|Stretching exercise|Participants in the control group receive 12-week group-based stretching exercise training.
15776599|NCT04641416|Diagnostic Test|Routinely performed echo, ECG and hemodynamic monitoring|The pump data of patients on the ICU or normal ward are stored in a continuous data acquisition system (CDAS) on a notebook which is operated in battery operation, and analyzed afterwards with a mat-lab based software. For outpatients a mobile data-recorder will allow a continuous data acquisition for a period up to 2 months on a SD card. During this non-invasive pump data monitoring, routinely available hemodynamic monitoring, ECG and echo data will be collected.
15776600|NCT04641403|Procedure|The surgeon performed Laparoscopic-assisted TAP (LTAP) block|After the induction of anesthesia, the first port will be inserted through the umbilicus and a 12 mmHg pneumoperitoneum will establish as a standard. Under the direct view of the laparoscopic camera, the block will be performed by inserting a 22-G needle just above the iliac crest through the midclavicular line posteriorly into the triangle of Petit and then inserting the needle below the costal arch through the midclavicular line towards the anterior axillary line into the subcostal plane. The block needle will be advanced under direct view until the two pops were felt and the extraperitoneal space will reach without puncturing the parietal peritoneum, and pulling back the needle 0.5 cm, the area of the thin transversus abdominis muscle fibers wiil be infiltrated. In this area, the correct plane of the needle tip will confirm by observing Doyle's bulge and the spread of the local anesthetic.
15776601|NCT04641390|Other|Analysis of the seminal microbiome of the partners of women with altered vaginal microbiome resistant to drug treatment|The analysis of the seminal microbiome will be carried out by massive genetic sequencing
15776602|NCT04641390|Other|Analysis of the seminal microbiome of the partners of women with altered vaginal microbiome not resistant to drug treatment|The analysis of the seminal microbiome will be carried out by massive genetic sequencing
15776640|NCT04641104|Drug|Thiamine 500 MG|A solution of 500 mg of Thiamine Hydrocloride in a solution of 100 ml of NaCl 0.9% will be administered post-cardiac surgery in patients with lactate levels ≥ 2 mmol / L in the first 6 hours post-ICU admission.
15776641|NCT04641104|Drug|Placebo|100 ml of NaCl 0.9% will be administered in the placebo group.
15776642|NCT04641091|Device|Multispectral Optoacustic Tomography (MSOT)|non-invasive transcutaneous imaging of subcellular muscle components
15776643|NCT04641078|Drug|Darolutamide|600 mg BID
15776603|NCT04641377|Other|Multicomponent exercise intervention plus health education|The multicomponent training will be performed twice a week, on pre-established and non-consecutive days. The sessions will be held by video call (approximately 60 min) in small groups (maximum three participants) and will be taught by students of the Physical Education course, previously trained to carry out the intervention. The order of the multicomponent training will be: joint mobilization, aerobic stimulus, balance exercise, strength exercises and stretching of the main muscles used during the training session. Health education will also be carried out on one of the two days. The conversation on the topic of the week will take place during stretching.
15776604|NCT04641377|Other|Health Education|Once a week, participants in the health education group will be sent a message with a material with various topics related to the management of breast cancer diagnosis and physical activity. In addition, two days after this material is sent, members of ABRACE: Telehealth will have a conversation with the participants of this group, at a google meet of approximately 30 minutes, about the theme sent by message. The themes will be: depression, pain, fatigue, body image, symptoms in the arm and breast, vasomotor symptoms, neuropathy, arthralgia, sexual dysfunction, quality of life, physical activity and eating habits.
15776605|NCT04641364|Drug|recombinant human albumin injection|single dose or multiple doses of intravenous infusion
15776606|NCT04641364|Drug|Placebo|Single dose intravenous infusion of 0.9% sodium chloride injection
15776607|NCT04641364|Drug|human albumin injection|multiple doses of intravenous infusion
15776608|NCT04641351|Drug|Zilretta Injectable Product or Placebo|The purpose of this intervention is to determine the use of extended release steroid knee injection (Zilretta) at the end of the surgery and its effects on your knee pain.In this study Zilretta will be injected intra-operatively for your arthroscopic partial meniscectomy (APM) surgery.Participants will have MRIs x-rays, and provide a sample of the synovial fluid from both knees at the beginning of surgery. This fluid is drained at the beginning of surgery and then usually discarded. Three samples each of blood and urine will be collected over the study period from each participant and sample of joint (synovial tissue) taken. Participants will be asked to answer questions about knee pain.
15776609|NCT04641338|Drug|Fixed dose combination Dipyrone and Codeine|Fixed dose combination: dipyrone 1000 mg + codeine 30 mg every 6 hours if necessary.
15776610|NCT04641338|Drug|Dipyrone|use of 1000 mg dipyrone every 6 hours if necessary.
15776611|NCT04641338|Drug|Codeine|30 mg codeine every 6 hours if necessary.
15776612|NCT04641325|Other|Exercise Intervention Group|Patients will be educated on methods of self-evaluating exertion and cardiovascular effort by assessing respiratory rate and perceived exertion. Next, patients will be given options for cardiovascular activities and complete at a moderate level of activity for a minimum of 150 minutes per week. Patients will perform a combination of exercises under the supervision of a physical therapist until a mod intensity level is reached and sustained. Patients will be taught to use the activity tracker to record their heart rate, activity, and PES. Patients will have a phone call every 2 weeks to assess status, answer questions, and provide guidance on progressing intensity or duration of exercise. At the end of 4 months all patients from both groups will return for re-assessment.
15776613|NCT04641325|Other|Current Care Group|CCG will act as the control for the first phase and will then be provided the exercise intervention during the second phase of the trial
15776617|NCT04641299|Drug|AZD8233|PCSK9-targeted ASO for the reduction of circulating levels of LDL-C.
15776618|NCT04641299|Drug|Placebo|Placebo solution
15776619|NCT04641286|Other|Body motion categorisation|All patients will receive passive motion categorisation monitoring
15776620|NCT04641273|Drug|BAY1817080|Tablet, intake orally.
15776621|NCT04641273|Drug|Placebo for BAY1817080|Tablet, intake orally.
15776622|NCT04641273|Drug|Placebo for Pregabalin|Capsule, intake orally.
15776623|NCT04641273|Drug|Pregabalin|Capsule, intake orally. Starting dose 75 mg BID first week, increase to 150 mg BID in second week.
15776624|NCT04641260|Drug|Fezolinetant|Oral
15776625|NCT04641247|Drug|Niraparib|Niraparib tablets or capsules will be given once a day via the oral route.
15776626|NCT04641234|Drug|Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)|As prescribed by the treating physician
15776627|NCT04641221|Behavioral|Weekly Yoga Classes|All participants are invited to attend weekly yoga classes.
15776628|NCT04641208|Device|mobile phone|The root mean square (RMS) of the signal will be calculated by using electromyography, and were normalized to the EMG data maximum voluntary isometric contraction (MVIC)
15776629|NCT04641195|Dietary Supplement|Vitamin D3 (cholecalciferol)|180,000 international units (IU) of vitamin D3 at enrollment, followed by 2000 IU once per day from enrollment to 8 weeks
15776630|NCT04641195|Dietary Supplement|Zinc (zinc gluconate)|40mg of zinc gluconate taken once per day from enrollment to 8 weeks
15776631|NCT04641195|Dietary Supplement|Zinc (zinc gluconate) & Vitamin D (cholecalciferol)|180,000 IU of vitamin D3 at enrollment, followed by 2000 IU of vitamin D3 and 40mg of zinc gluconate once per day from enrollment to 8 weeks
15776632|NCT04641195|Other|Placebo|Placebo vitamin D bolus at enrollment followed by placebo daily vitamin D maintenance doses and placebo daily zinc supplements.
15776633|NCT04641182|Other|Prone position|Prone position as indicated by the treating physician as specified in the institutional protocol
15776634|NCT04641169|Procedure|echocardiography|Four measurements in echocardiography performed in addition to standard care
15776635|NCT04641156|Other|Exercise Therapy program added to laser therapy|a supervised physical therapy exercise program for the neck muscles in the form of manual mobilizations for sternocleidomastoid muscle and upper fibers of trapezius in addition to myofascial trigger point release
15776636|NCT04641143|Drug|Troriluzole|Troriluzole - 2 100mg capsules QD for the first two weeks.
15776637|NCT04641143|Drug|Placebo|Matching placebo - 2 140mg capsules QD from week two through week ten.
15776638|NCT04641130|Other|Exposure to birch pollen in EEC|Patients are exposed to airborne birch pollen allergen. The duration of each exposure is 4h maximum.
15776639|NCT04641117|Other|Exercise|Walking and Power Training
15776644|NCT04641078|Radiation|metastasis-directed treatment|stereotactic body radiotherapy
15776645|NCT04641065|Other|Music listening|An expert on the particular type of music will do the selection of the playlist of Traditional Turkish Military music, and this playlist will be listened to the patients by the researchers.
15776646|NCT04641052|Other|Music listening|The music type will be chosen by the patients and researchers will not have any influence on their choices.
15776647|NCT04641039|Procedure|Anterior lumbar disc annulus removal versus replacement|Owestry scale, SF12, Facet joint arthritis measured with Pathria scale, discal degeneration measured with Modic and Phirrmann scales
15776648|NCT04641026|Other|Broccoli sprouts|Subjects will consume one serving (about 1 cup) of broccoli sprouts with breakfast (bagel, cream cheese, and orange juice).
15776649|NCT04641026|Other|Deuterium oxide-labelled broccoli sprouts|Subjects will consume one serving (about 1 cup) of deuterium oxide-labelled broccoli sprouts with breakfast (bagel, cream cheese, and orange juice).
15776650|NCT04641026|Other|Alfalfa sprouts|Subjects will consume one serving (about 1 cup) of alfalfa sprouts with breakfast (bagel, cream cheese, and orange juice).
15776651|NCT04641026|Other|Deuterium oxide-labelled alfalfa sprouts|Subjects will consume one serving (about 1 cup) of deuterium oxide-labelled alfalfa sprouts with breakfast (bagel, cream cheese, and orange juice).
15776652|NCT04640987|Biological|Allogeneic Stem Cell Transplant|The allogeneic stem cell transplant involves transferring the stem cells from a healthy person (donor) to the participant via infusion.
15776653|NCT04640987|Device|CliniMACS Prodigy System|Device used for production of T-allo10 cells.
15776654|NCT04640987|Drug|T-allo10 cells addback|T-allo10 cells are made by manipulating the participant's stem cell donor's white blood cells (CD4+ T cells) in the presence of their (participant's) CD14+ monocytes.
15776655|NCT04640974|Device|Cingal|CINGAL® is a chemically cross-linked sodium hyaluronate combined with Triamcinolone Hexacetonide supplied as a 4-mL unit dose in a 5-mL glass syringe.
15776656|NCT04640961|Device|Cingal|CINGAL® is a chemically cross-linked sodium hyaluronate combined with Triamcinolone Hexacetonide supplied as a 4-mL unit dose in a 5-mL glass syringe.
15776657|NCT04640948|Device|High flow nasal therapy|Controlled oxygen administration using at least 20 L/min of flow rate and titrated up as tolerated. Titration of supplemental oxygen to an arterial saturation between 88 - 92%.
15776658|NCT04640948|Device|Low flow oxygen|Controlled oxygen administration using (venturi mask or nasal cannulae) titrated to an arterial saturation between 88 - 92% as the initial oxygen administration method with a flow rate of <20 L/min.
15776659|NCT04640922|Device|Gedea Pessary pHyph|Vaginal tablet
15776660|NCT04640922|Device|Placebo|Vaginal tablet
15776661|NCT04640909|Other|Peripheral blood samples withdrawal|Peripheral blood samples evaluation
15776662|NCT04640896|Drug|Trigger point injection with bupivacaine|Trigger point injections will be performed within an hour of arrival in PACU, given that the patient has adequately woken up from general anesthesia. Injections will be performed by an anesthesiology provider using a standardized technique under strict aseptic conditions. The trigger point will be located between two fingers, and a 1-2cm sterile needle with a thickness of 25 or 26 gauge inserted at 30 degrees with respect to the skin. Negative aspiration will be confirmed before injecting the study solution. The needle will be withdrawn to the subcutaneous tissue and redirected superiorly, inferiorly, laterally and medially, injecting study solution at each location. Pressure will be applied to the area to ensure hemostasis, and the area dressed with gauze and tape as needed.
15776663|NCT04640896|Drug|Trigger point injection with normal saline|Trigger point injections will be performed within an hour of arrival in PACU, given that the patient has adequately woken up from general anesthesia. Injections will be performed by an anesthesiology provider using a standardized technique under strict aseptic conditions. The trigger point will be located between two fingers, and a 1-2cm sterile needle with a thickness of 25 or 26 gauge inserted at 30 degrees with respect to the skin. Negative aspiration will be confirmed before injecting the study solution. The needle will be withdrawn to the subcutaneous tissue and redirected superiorly, inferiorly, laterally and medially, injecting study solution at each location. Pressure will be applied to the area to ensure hemostasis, and the area dressed with gauze and tape as needed.
15776664|NCT04640896|Drug|Lidocaine skin wheal|"Patients in the control group will receive a small skin wheal of lidocaine. This will keep the patient blinded to the study group they are in since all patients will receive an injection.
~However, this skin wheal is not considered a trigger point injection."
15776665|NCT04640883|Behavioral|Inclusion of sprints during low-intensity cycling during a 14-day training camp (high training load)|Inclusion of 12x30-s maximal sprints during five low-intensity cycling sessions with long duration (>fours hours per session). Five sessions will be performed as low-intensity cycling-only (Controll sessions, distance matched). All other sessions will be performed as low-intensity sessions and adjusted according to each participants training load goal to reach an increase of ~50% in load compared to habitual training.
15776666|NCT04640883|Behavioral|Low-intensity cycling during a 14-day training camp (high training load)|Five low-intensity cycling sessions (>four hours per session), distance-matched to sprint group.
15776667|NCT04640883|Behavioral|Recovery for 10 days (low training load)|Habitual low-intensity cycling (>0.5-2 hours per session)
15776668|NCT04640870|Drug|Afatinib|Treatment with Afatinib, any line, in metastatic, EGFR mutated patients with NSCLC
15776669|NCT04640857|Device|Silk'n Toothwave|patients will receive a non-surgical treatment which will include oral hygiene instructions, calculus removal with ultrasonic and manual instruments. At the end of the meeting they will be provided with a toothbrush which is based on a radiofrequency technology.
15776670|NCT04640844|Biological|blood sample|measuring the expression and function of lymphocyte A2A receptors.
15776671|NCT04640831|Drug|5 Methoxy N,N Dimethyltryptamine|GH001 administered via inhalation
15776672|NCT04640818|Drug|Cladribine Oral Tablet|Treatment according to the label and medical prescription
15776673|NCT04640818|Drug|Rituximab|Treatment according to the label and medical prescription
15776674|NCT04640818|Drug|Ocrelizumab|Treatment according to the label and medical prescription
15776675|NCT04640805|Dietary Supplement|Protein supplementation|Liquid protein fortifier (Similac) will be added at 1ml per 25ml of PDHM at 130ml/kg/day of feed volume.
15776676|NCT04640805|Other|Analysis with Miris Human Milk Analyzer|PDHM macronutrient content will be analyzed using the Miris Human Milk Analyzer and PDHM with fat content of 3.8g/dL or higher will be selected and provided.
15776677|NCT04640792|Procedure|Screening or Surveillance Conventionall colonoscopy|Patients in Group A (CC) will undergo Screening or Surveillance Conventual Colonoscopy, Patients in Group B (MEAC) will undergo Screening or Surveillance Colonoscopy with ME-ADPS Device
15776678|NCT04640779|Drug|Choline Salicylate|Given PO
15776679|NCT04640779|Drug|Selinexor|Given PO
15776680|NCT04640766|Device|PRISM|"The study will include 12 EEG-NF sessions, administered twice per week for a duration of 6 active weeks in total. Twice weekly sessions will be held on no-consecutive days. Each session will last approximately 30 minutes."
15776681|NCT04640753|Procedure|Endoscopic procedure for achalasia|POEM procedure will have a high technical feasibility, with effective clinical resolution of symptoms both in the short and long term.
15776682|NCT04640740|Procedure|hip arthroplasty|two different approaches of total hip arthroplasty
15776683|NCT04640727|Procedure|open reduction|A sterile tourniquet is applied and an oblique posterolateral skin incision is made. Superficial dissection is carried out in the plane of the fracture hematoma until the distal lateral corner of the proximal fragment is identified. Once the metaphyseal side of the fracture has been identified, the dissection is carried across the joint to expose the medial articular surface. After exposure of the proximal fragment, the orientation of the distal fragment is defined and the soft tissues are sharply released off the anterior aspect of the distal fragment, with extension carried distally to the radial head. After irrigation and débridement of the fracture hematoma, the distal fragment is reduced with a towel clip. It is important to judge the reduction at the level of the articular surface rather than the metaphysis because plastic deformation or comminution of the metaphyseal fragment may be present. Pins (usually 0.062 inch) are placed percutaneously to secure the fracture.
15776684|NCT04640727|Procedure|closed reduction|we applied a gentle varus force to the elbow while the patient was under general anesthesia, and we attempted to reposition the rotated fragment by directly pushing or by using Kirschner wires as joysticks . After repositioning, we applied gradual direct compression to the distal fracture fragment anteromedially.We then applied slight valgus force to the elbow with the forearm supinated and the elbow fully extended to maintain the reduction. After the fracture reduction was confifirmed to be within 2 mm, especially as seen on the anteroposterior, lateral radiographs,and internal obliquewe used smooth Kirschner wires to perform percutaneous pinning
15776685|NCT04640714|Behavioral|CONTINUity of care Under Management by Video visits (CONTINUUM-V)|Video visit by nurse practitioner within 3 business days of hospital discharge.
15776686|NCT04640688|Procedure|Bariatric procedures|510(k) summary K081853 dated June 26, 2008, Endoscopic Sleeve Gastroplasty lecture, Methodist Dallas Medical Center Endobariatric Pathway & Endoscopic Sleeve Gastroplasty Procedure Description
15776687|NCT04640662|Biological|Platelet-Rich Plasma|Single-injection of 2 ml PRP into the lesion under ultrasound-guided
15776688|NCT04640662|Biological|Prolotherapy|Single-injection of 2ml dextrose 16.5% into the lesion under ultrasound-guided
15776689|NCT04640649|Other|Algorithm prediction|Patients with early and intermediate AMD in at least one eye who are at risk of converting to wet AMD or GA expansion will be randomly assigned to a test group or control group. The test group will have their baseline data analyzed by an algorithm to predict the probability of conversion to wet AMD. If the probability is high for conversion at or before 3 months, patients will have earlier follow-up care than the control group (standard follow-up care every 6 months).
15776690|NCT04640636|Drug|Ketamine hydrochloride injection|single IM injection of ketamine hydrochloride 0.5 mg/kg
15776691|NCT04640636|Drug|Midazolam injection|single IM injection of midazolam 0.06 mg/kg
15776692|NCT04640623|Drug|TAR-200|TAR-200 will be administered transuretherally.
15776693|NCT04640623|Biological|Cetrelimab|Cetrelimab will be administered.
15776694|NCT04640610|Other|Storage of operating waste|Storage of operating waste of adenoidectomy / tonsillectomy
15776695|NCT04640597|Device|BioMimics 3D Vascular Stent System|Patients with BioMimics 3D Vascular Stent System
15776696|NCT04640584|Device|C-Brace|The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.
15776697|NCT04640571|Drug|pravastatin and chenodeoxycholic acid, after metformin and placebo|single oral dose of pravastatin 80 mg and chenodeoxycholic acid 250 mg
15776698|NCT04640571|Drug|valacyclovir, chenodeoxycholic acid, and enalaprilat, after polysorbate 80 and placebo|single oral dose of valacyclovir 500 mg, chenodeoxycholic acid 250 mg, and enalaprilat 20 mg
15776699|NCT04640558|Device|Muscle strength measurement|The bilateral gluteus medius muscle strength of each participant will be measured by the assessor (MB) blinded to the participants using the Lafayette manual muscle tester. (Lafayette Instrument Company, Lafayette IN, USA). In the participant's side-lying position, the practitioner applied resistance from the upper ankle to the abduction movement with slight flexion of the upper hip. During the measurements, the participants were asked to perform the maximum isometric contraction for 3 seconds. Gluteus medius muscle strength measurements were repeated three times, one minute apart, on the right and left sides. The mean of the measurements was calculated and recorded
15776700|NCT04640545|Drug|LBL-007|LBL-007 will be administered intravenously every two weeks (Q2W) at doses of Dose A, Dose B, Dose C,Dose D .
15776701|NCT04640545|Drug|Toripalimab|Toripalimab Injection will be administered by intravenously (Q2W) by the fixed dose of 3 mg/kg .
15776702|NCT04640532|Drug|KRT-232|KRT-232, administered by mouth
15776703|NCT04640532|Drug|TL-895|TL-895, administered by mouth
15776704|NCT04640519|Other|Usual care|Usual care patients will be seen by a primary care nurse practitioner and a stroke neurologist.
15776705|NCT04640519|Other|TASC intervention|TASC patients will receive a BP monitoring kit and electronic tablet with patient tailored BP infographics. They will be scheduled with 5 telehealth visits over 3 months, including primary care nurse practitioner, pharmacy and stroke neurologist.
15776706|NCT04640493|Drug|Dapagliflozin|If patients have been diagnosed with SDB using the WatchPat device, they will start dapagliflozin. Repeat WatchPat SDB assessment will be performed after 3 and 6 months of continuous dapagliflozin therapy.
15776707|NCT04640493|Device|WatchPat|HF patients undergo SDB testing with the WatchPat device.
15776709|NCT04640467|Diagnostic Test|Biophsical profile|There are five components measured during the biophysical examination. A score of 2 points is given for each component that meets criteria. The test is continued until all criteria are met or 30 minutes have elapsed. The points are then added for a possible maximum score of 10. A total score of 10 out of 10 or 8 out of 10 with normal fluid is considered normal. A score of 6 is considered equivocal, and a score of 4 or less is abnormal.
15776710|NCT04640467|Diagnostic Test|Cerebroplacental ratio|CPR is the ratio of the Middle Cerebral Artery Pulsatility Index (MCA PI) to the Umbilical Artery Pulsatility Index (UA PI). The pulsatility indices will be measured from an automated trace of at least three consecutive waveforms of the relevant vessel in the absence of fetal breathing movements or uterine contractions. The angle of insonation will be as close to zero degrees as possible. The UA PI will be recorded from a free-floating section of cord, and the MCA PI will be obtained from the proximal third of the vessel (10, 14).
15776711|NCT04640454|Procedure|nipple sparing mastectomy|The investigators categorized the incisions into radial, inframammary, and periareolar incisions with planned reconstruction types; direct to implant (DTI), transversus rectus abdominis myocutaneous (TRAM) flap, latissimus dorsi myocutaneous (LD) flap, or LD with implant.
15776712|NCT04640441|Other|Sit-to-stand care|"Passive range of motion(ROM) exercise of lower legs, active ROM exercise of lower legs, and sitting balance exercise, 20~30 min, once daily.
~Anti-gravity ROM exercise of lower leg, resistance exercise of low leg, and sitting balance exercise, 20~30min, once daily.
~Stepping exercise and sit-to-stand exercise, 20~30min, once daily."
15776713|NCT04640415|Device|Active Alarms|Intervention consists of actively alerting staff personnel if physiologic vital signs, deviates from certain thresholds for more than a set duration. Continuous vital sign data will also be available to clinical staff.
15776714|NCT04640402|Biological|Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen|18-59 years group, two doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
15776715|NCT04640402|Biological|Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen|18-59 years group, three doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
15776716|NCT04640402|Biological|High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Two dose regimen|18-59 years group, two doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
15776717|NCT04640402|Biological|High-dose Recombinant COVID-19 vaccine (Sf9 cells) (18-59 years) & Three dose regimen|18-59 years group, three doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
15776718|NCT04640402|Biological|Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen|60-85 years group, two doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
15776719|NCT04640402|Biological|Low-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen|60-85 years group, three doses of low-dose (20µg/0.5ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
15776720|NCT04640402|Biological|High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Two dose regimen|60-85 years group, two doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 21.
15776721|NCT04640402|Biological|High-dose Recombinant COVID-19 vaccine (Sf9 cells) (60-85 years) & Three dose regimen|60-85 years group, three doses of high-dose (40µg/1.0ml) Recombinant COVID-19 vaccine (Sf9 cells) at the schedule of day 0, 14, 28.
15776722|NCT04640402|Biological|Low-dose placebo (18-59 years) & Two dose regimen|18-59 years group, two doses of placebo(0.5ml) at the schedule of day 0, 21.
15776723|NCT04640402|Biological|Low-dose placebo (18-59 years) & Three dose regimen|18-59 years group, three doses of placebo(0.5ml) at the schedule of day 0, 14, 28.
15776724|NCT04640402|Biological|High-dose placebo (18-59 years) & Two dose regimen|18-59 years group, two doses of placebo(1.0ml) at the schedule of day 0, 21.
15776725|NCT04640402|Biological|High-dose placebo (18-59 years) & Three dose regimen|18-59 years group, three doses of placebo(1.0ml) at the schedule of day 0, 14, 28.
15776726|NCT04640402|Biological|Low-dose placebo (60-85 years) & Two dose regimen|60-85 years group, two doses of placebo(0.5ml) at the schedule of day 0, 21.
15776727|NCT04640402|Biological|Low-dose placebo (60-85 years) & Three dose regimen|60-85 years group, three doses of placebo(0.5ml) at the schedule of day 0, 14, 28.
15776728|NCT04640402|Biological|High-dose placebo (60-85 years) & Two dose regimen|60-85 years group, two doses of placebo(1.0ml) at the schedule of day 0, 21.
15776729|NCT04640402|Biological|High-dose placebo (60-85 years) & Three dose regimen|60-85 years group, three doses of placebo(1.0ml) at the schedule of day 0, 14, 28.
15776730|NCT04640389|Other|Cross-sectional study/no intervention|Cross-sectional study/no intervention.
15776731|NCT04640376|Drug|Paracetamol Uniflash 125mg|Oromucosal solution 1.25 mL for buccal use
15776732|NCT04640376|Drug|Panadol 500 MG Oral Tablet X1|Tablet masked in capsule
15776733|NCT04640376|Drug|Panadol 500 MG Oral Tablet X2|Tablet masked in capsule
15776734|NCT04640376|Drug|Placebo|Dummy treatment
15776735|NCT04640337|Other|IPE applied, participants believe they are receiving IPE|Participants will receive a total of 3 sessions of IPE, with a time interval of one week between the 1st and 2nd session and 2 weeks between the 2nd and 3rd session. IPE will be applied following the standard protocol for PT. Participants will believe they are receiving IPE.
15776736|NCT04640337|Other|IPE applied, participants believe they are receiving placebo|Participants will receive a total of 3 sessions of IPE, with a time interval of one week between the 1st and 2nd session and 2 weeks between the 2nd and 3rd session. IPE will be applied following the standard protocol for PT. Subjects will be led to belie
15776737|NCT04640337|Other|IPE not applied, participants believe they are receiving IPE|Participants will receive a total of 3 sessions of IPE-placebo, with a time interval of one week between the 1st and 2nd session and 2 weeks between the 2nd and 3rd session. The needle will be inserted under the skin but the current will not be passing th
15776738|NCT04640337|Other|IPE not applied, participants believe they are receiving placebo|Participants will receive a total of 3 sessions of IPE-placebo, with a time interval of one week between the 1st and 2nd session and 2 weeks between the 2nd and 3rd session. The needle will be inserted under the skin, subjects will be led to believe that the intensity of the current is below the threshold necessary to cause changes in the tissue.
15776739|NCT04640324|Drug|Nutraceutical therapy|Oral administration of 303mg of silybin-phospholipid complex, 10mg of vitamin D, and 15mg of vitamin E, twice a day for six months
15776740|NCT04640311|Drug|Daprodustat|Daprodustat will be available as oral tablets.
15776741|NCT04640298|Device|Cingal|CINGAL® is a chemically cross-linked sodium hyaluronate combined with Triamcinolone Hexacetonide supplied as a 4-mL unit dose in a 5-mL glass syringe.
15776742|NCT04640285|Other|RELX ENDS Tobacco Flavor|Ad libitum use of RELX ENDS tobacco flavor product during 8-hour and 5-minute use sessions
15776743|NCT04640285|Other|RELX ENDS Menthol Flavor|Ad libitum use of RELX ENDS Menthol flavor product during 8-hour and 5-minute use sessions
15776744|NCT04640285|Other|Usual Brand Cigarette|Ad libitum use of subjects usual brand product during 8-hour and single cigarette use sessions
15776745|NCT04640285|Other|Nicorette White Ice Mint nicotine polacrilex gum|Ad libitum use of Nicorette White Ice Mint nicotine polacrilex gum product during 8-hour and 30-minute use sessions
15776747|NCT04640259|Other|Online Survey|Epidemiological Survey (approx 200 questions)
15776748|NCT04640246|Biological|TBX-3400|Autologous transfusion
15776749|NCT04640233|Biological|Gam-COVID-Vac|Vaccine for intramuscular injection
15776750|NCT04640233|Other|Placebo|Placebo comparator
15776751|NCT04640220|Procedure|Intra-articular steroid injection|Ultrasound-guided Gleno-humeral joint steroid (Triamcinolone 40mg with 0.5% lidocaine ) injection
15776752|NCT04640207|Device|Facial skin treatment|Facial skin treatment using the Alma Hybrid system with a unique pattern that includes both ablative and non-ablative wavelengths
15776755|NCT04640181|Drug|Enoxaparin|Subcutaneous enoxaparin While hospitalized only.
15776756|NCT04640181|Drug|Rivaroxaban|Oral rivaroxaban While hospitalized and through discharge for a total of 28 days.
15776757|NCT04640168|Drug|Baricitinib|Baricitinib is a Janus kinase (JAK) inhibitor with the chemical name [1-(ethylsulfonyl)-3-(4-(7Hpyrrolo(2,3-d)pyrimidin-4-yl)-1H-pyrazol-1-yl)azetidin-3-yl]acetonitrile. Each tablet contains 2 mg of baricitinib and the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, ferric oxide, lecithin (soya), polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
15776758|NCT04640168|Drug|Dexamethasone|Dexamethasone Sodium Phosphate Injection, USP, is an adrenocortical steroid anti-inflammatory drug. It is a water-soluble inorganic ester of dexamethasone. Each mL contains dexamethasone sodium phosphate equivalent to dexamethasone phosphate 4 mg or dexamethasone 3.33 mg; benzyl alcohol 10 mg added as preservative; sodium citrate dihydrate 11 mg; sodium sulfite 1 mg as an antioxidant.
15776759|NCT04640168|Other|Placebo|Placebo matching oral baricitinib or intravenous dexamethasone.
15776760|NCT04640168|Drug|Remdesivir|Drug remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.
15776761|NCT04640155|Behavioral|Low FODMAP Diet|Patients in the low FODMAP group will schedule a telephone visit with a registered dietician. During this approximately hour-long session, patients in the low FODMAP cohort will be counselled regarding FODMAP containing foods and how to effectively remove them while maintaining a nutrition-rich diet.
15776762|NCT04640155|Behavioral|Regular Diet|Patients in the regular diet group will receive an educational handout discussing low fiber diet, which is standard of care for those with pouchitis symptoms.
15776764|NCT04640129|Drug|PEG-Interferon Alfa, Tenofovir Disoproxil Fumarate|Combination therapy group was treated with PEG-interferon Alfa in addition to TDF monotherapy
15776765|NCT04640129|Drug|Tenofovir Disoproxil Fumarate|TDF monotherapy
15776766|NCT04640116|Procedure|Transjugular intrahepatic portosystemic shunt (TIPS)|A needle punctured the portal vein through the transjugular approach. After a successful puncture, the parenchymal tract was dilated, and covered stents (GORE® VIATORR) were introduced. The specifications of the covered stents were 8 mm × 50 mm, 8 mm × 60 mm, 8 mm × 70 mm, and 8 mm × 80 mm. All of the diameters of the bare stents were 8 mm, and the lengths were 50-80 mm. The portal vein pressure was measured before and after shunt creation. After the insertion of TIPS, all of the patients received a diuretic treatment and a salt-limited diet until the ascites disappeared.
15776767|NCT04640116|Procedure|microwave ablation (MWA)|MWA: After the patient's ascites disappears, MWA therapy will be performed. A MWA antenna was gradually inserted into the tumor along the predetermined angle under the guidance of Computed Tomography (CT). The whole thermal procedure was conducted under intravenous anesthesia. Vital signs were monitored during the procedure. The settings of the ablation parameters depended upon the manufacturer's recommendation and our experience. Ablation volume was determined by physicians according to liver function, tumor invasion site, and tumor stage. An upper abdominal CT scan was carried out immediately after the procedure to evaluate the ablation area and complications.
15776768|NCT04640103|Other|No interventions|No interventions
15776769|NCT04640090|Behavioral|Smartphone app (Wysa)|The commercially available smartphone application, Wysa, offers evidence-based wellness tools such as supportive listening, deep breathing techniques, guided meditation, yoga, and more. Users can communicate via text to a virtual artificial intelligence (AI) chatbot and/or a human well-being coach.
15776772|NCT04640051|Procedure|LAAO|LAAO by use of 3D in silico simulation by FEops HEARTguide as part of the pre-procedural assessment and device size selection
15776816|NCT04639765|Other|ADM with Personalization|Intervention involves a video describing antidepressant medication with a message about personalization.
15776773|NCT04640038|Drug|Sulfur hexafluoride lipid-type A microspheres|Injection of Sulfur hexafluoride lipid-type A microspheres (Lumason) contrast agent will be performed via the existing peripheral intravenous line using the FDA-recommended dose of 0.03 mg/kg. Two bolus injections will be performed to evaluate for dynamic bowel perfusion and several 2-minute cine clips as well as static images will be acquired during the exam.
15776774|NCT04640025|Drug|itacitinib|Participants will self-administer itacitinib orally using intact tablets with water and without regard to food.
15776775|NCT04640012|Drug|DC371739|Participants received one of 6 dose levels of DC371739 administered as single oral doses.
15776776|NCT04640012|Drug|Placebo|Placebo orally administered
15776777|NCT04639999|Other|Echocardiography|LV vortex flow in Echocardiography
15776778|NCT04639986|Drug|sacituzumab govitecan (IMMU-132)|Sacituzumab govitecan 10 mg/kg via IV injection administered on Days 1 and 8 of a 21-day cycle. Subjects will continue to receive study treatment until PD as judged by local investigator review, development of unacceptable toxicity, or withdrawal of consent.
15776779|NCT04639986|Drug|Eribulin Mesylate Injection|Eribulin is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
15776780|NCT04639986|Drug|Capecitabine Oral Product|Capecitabine is administered orally (PO) following recommended doses and regimens as per approved package inserts.
15776781|NCT04639986|Drug|Gemcitabine Injection|Gemcitabine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
15776782|NCT04639986|Drug|Vinorelbine injection|Vinorelbine is administered by intravenous (IV) following recommended doses and regimens as per approved package inserts.
15776783|NCT04639973|Diagnostic Test|Group 1 (First trimester ultrasound)|A detailed first trimester anatomy ultrasound will be performed,at the visit when the subject is confirmed to be of eligible gestational age. After this detailed research ultrasound, which will be limited to 15 minutes, subject will then receive the clinically indicated dating ultrasound or nuchal translucency measurement. The patient will complete a survey about her satisfaction with this technique via email.as a safety measure, if an anomaly is suspected on the day of the detailed first trimester anatomy scan, the patient will be unblinded. Patients in this arm are later scheduled for a second trimester ultrasound by the clinical team, as this is part of standard obstetrical care.
15776784|NCT04639973|Diagnostic Test|Group 2 (Second trimester anatomy ultrasound)|Patients do not undergo a detailed first trimester ultrasound , but will receive the clinically indicated limited ultrasound for dating or for nuchal translucency. Patient will then undergoes a second trimester ultrasound by the clinical team as part of standard obstetrical care and completes a survey regarding her satisfaction with this technique via email.
15776785|NCT04639960|Drug|Risperdal|Twelve weeks of treatment with a gradual increase of dosage over one week and a gradual decrease over two weeks.
15776786|NCT04639960|Drug|Placebo|Twelve weeks of placebo treatment.
15776787|NCT04639947|Device|EyeCheck|EyeCheck is a newly developed device to provide intraocular pressure (IOP) measurements of the eyes.
15776788|NCT04639947|Device|Traditional Tonometer (Goldmann and Tonopen)|Standard of care intraocular pressures will be taken using the Goldmann and Tonopen to compare to the EyeCheck.
15776789|NCT04639934|Genetic|MeTree|Software program collecting family health history and generating clinical decision support for risk-based preventive care
15776790|NCT04639921|Diagnostic Test|positive test followed by gluten-free diet|DBPCFC with gluten
15776791|NCT04639921|Dietary Supplement|Placebo|Placebo
15776792|NCT04639908|Other|Interview|interview with patient
15776793|NCT04639895|Procedure|Virtual Reality|The Virtual Reality group will be involved in the Standard treatment protocol and will perform personalized activities of daily living in a virtual city environment (Reh@City).
15776794|NCT04639895|Procedure|Paper and Pencil|The paper and Pencil group will be involved in the Standard treatment protocol and will perform personalized cognitive paper-and-pencil tasks, using the Task Generator tool.
15776795|NCT04639895|Procedure|Control Group|The standard treatment protocol.
15776796|NCT04639882|Behavioral|Personalized normative feedback|Information presenting perceived and actual drinking norms.
15776797|NCT04639869|Drug|Phenyramydol HCl 400 mg Film Tablet|Phenyramydol HCL 400 mg Film Tablet contains 400 mg phenyramydol manufactured by Pharmactive Ilac.San ve Tic A.S
15776798|NCT04639869|Drug|Cabral 400 mg Film Tablet|Cabral 400 mg Film Tablet 400 mg phenyramydol manufactured by Recordati Ilac SAn ve Tic A.S.
15776799|NCT04639856|Procedure|Coronary Artery Bypass Grafting|on-pump vs off pump Coronary artery Bypass Grafting
15776804|NCT04639817|Drug|Levofloxacin|Levofloxacin administration
15776805|NCT04639817|Drug|trimethoprim-sulfamethoxazole|Trimethoprim-sulfamethoxazole administration
15776806|NCT04639804|Drug|Tegoprazan|Tegoprazan 50 mg tablet
15776807|NCT04639804|Drug|Naproxen|Naproxen 500 mg tablet
15776808|NCT04639804|Drug|Aceclofenac|Aceclofenac 100 mg tablet
15776809|NCT04639804|Drug|Celecoxib|Celecoxib 200 mg capsule
15776810|NCT04639791|Other|No intervention|Observation only, no intervention
15776811|NCT04639778|Other|Control Group|Clinical visits conducted by a multidisciplinary team every year
15776812|NCT04639778|Other|Intervention Group|Clinical visits are triggered by weight evolution measured by connected balance
15776813|NCT04639765|Other|CBT without Personalization|Intervention involves a video describing CBT without a message about personalization.
15776814|NCT04639765|Other|CBT with Personalization|Intervention involves a video describing CBT with a message about personalization.
15776815|NCT04639765|Other|ADM without Personalization|Intervention involves a video describing antidepressant medication without a message about personalization.
15776846|NCT04639466|Biological|Vaccine Therapy|Given COH04S1 IM in the non-dominant upper arm
15776817|NCT04639765|Other|Combined Treatment without Personalization|Intervention involves a video describing the combination of cognitive behavior therapy and antidepressant medication without a message about personalization.
15776818|NCT04639765|Other|Combined Treatment with Personalization|Intervention involves a video describing the combination of cognitive behavior therapy and antidepressant medication with a message about personalization.
15776819|NCT04639752|Behavioral|Mom´s Supporting Mom|A preventive peer consultation intervention for Postpartum Depression.
15776820|NCT04639752|Behavioral|Enhanced Treatment As Usual|Referral to treatment in the community, clinical monitoring
15776821|NCT04639739|Biological|anti-CD19 CAR NK|2×106 /kg、6×106 /kg、2×107/kg Treatment follows a lymphodepletion, the recommended chemotherapy regimen consists of Fludarabine (30 mg/m2 per day) and Cyclophosphamide (500mg/m2 per day) for 3 days prior to cell infusion，the actual regiment is determined by the statue of patients.
15776822|NCT04639726|Dietary Supplement|Whey Protein Micro Gel|The test product is whey protein microgels 10g, reconstituted in 125ml water.
15776823|NCT04639726|Other|Water without Whey Protein.|A matching placebo (125ml of water without whey protein) will be used as control.
15776825|NCT04639700|Behavioral|Psycho-educational intervention|"Participant will be sent a baseline survey, and will then be contacted by the interventionist to complete 4 sessions, which feature the following areas:
~Session 1: Identifying CG Needs for Information & Support, Communication with Healthcare Team
~Session 2: Communication with Patient and Family
~Session 3: Self-care: Emotional & Spiritual Needs, Self-care: Physical Needs
~Session 4: Re-Assessing Needs, Planning for the future"
15776826|NCT04639687|Behavioral|Food as Medicine Delivery|12 consecutive weeks of home-delivered vegetables plus whole grain foods along with weekly text containing educational video
15776827|NCT04639674|Drug|AST-120|If no other medicines are taken usually, take AST-120 one hour after each meal with a frequency of three doses a day and one dose every administration. The drug will be taken for four weeks.
15776828|NCT04639635|Other|No intervention, this is a natural history progression study|The objective is to better understand the disease process of CNGB1-RP so that we can develop clinical tests to measure the outcomes of treatment.
15776829|NCT04639622|Diagnostic Test|Investigation procedures|All participants will be assessed longitudinally with a set of clinical evaluation, neuropsychiatric and cognitive assessments, imaging (MRI and PET scans) and biosample (CSF, blood samples)
15776830|NCT04639609|Other|Characterization of Neuromuscular Function and Fatigue|at inclusion
15776831|NCT04639596|Behavioral|Mindfulness-based Therapeutic Sailing (MBTS) versus a standard recreation therapy activity, bowling, (SRT).|This study will be a prospective randomized controlled trial (RCT) of Mindfulness-based Therapeutic Sailing (MBTS) versus a standard recreation therapy activity (bowling) among Veterans with psychiatric and/or substance use disorders.
15776832|NCT04639583|Device|Near-infrared spectroscopy (NIRS) utilization|The NIRS devise will be applied so that cerebral regional oxygen saturation (cRSO2) can be measured.
15776833|NCT04639570|Other|KneuroKnits|The KneuroKnits program will be based upon current knitting education practices and leading practices in facilitation of social participation for individuals with neurodevelopmental disorders, physical disabilities, and acquired brain injuries. The program will consist of 4 weekly sessions in which participants will learn knitting fundamentals and have opportunities to socialize over a shared occupation. The 4 weekly sessions of the KneuroKnits curriculum will include related knitting and social skills themes of the week. Each session will begin with a structured lesson on the knitting topic of the day, and will then continue into knitting practice and social interaction. Participants will be encouraged to practice their new skills (knitting and social) between sessions, and will be allowed to keep all materials that they use or create.
15776834|NCT04639557|Behavioral|BRIDGE Therapy Program|The BRIDGE Therapy Program is a novel manualized therapy that incorporates key parenting concepts and related Dialectical Behavior Therapy (DBT) modules. The primary aim of the program is to promote self-regulation in the mother-child dyads. There are two components of the program: 1) the DBT section, which will follow the DBT Skills Training Manual 2nd Edition and target maternal mental health symptomology, and 2) the parent skill training materials, which have been designed to correspond to the four core DBT modules (i.e., Mindfulness, Emotion Regulation, Distress Tolerance, and Interpersonal Effectiveness) and to promote self-regulatory skill development and a positive parent-child relationship.
15776835|NCT04639544|Dietary Supplement|Placebo|Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits
15776836|NCT04639544|Dietary Supplement|Lactobacillus strain|Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits
15776837|NCT04639531|Behavioral|Orientation and Mobility Training with VR-IOMSs|Learning Orientation and Mobility skills from virtual-reality-based, automated, intelligent computer training programs - VR-IOMSs
15776838|NCT04639531|Behavioral|Orientation and Mobility Training with COMS|Learning Orientation and Mobility skills from human Certified Orientation and Mobility Specialists (COMS)
15776839|NCT04639531|Behavioral|No Orientation and Mobility Training|No Orientation and Mobility training. Watch low vision education videos and discuss low vision issues not related to O&M with COMS
15776840|NCT04639518|Other|Preterm formulas with HMO|Preterm infants will receive Stage 1 formula as soon as possible after birth until when 1.8 kg of body weight is achieved. Preterm infants will receive Stage 2 preterm formula from when 1.8 kg of body weight is achieved until 2 months after hospital discharge.
15776841|NCT04639518|Other|Preterm formulas without HMO|Preterm infants will receive Stage 1 formula as soon as possible after birth until when 1.8 kg of body weight is achieved. Preterm infants will receive Stage 2 preterm formula from when 1.8 kg of body weight is achieved until 2 months after hospital discharge.
15776842|NCT04639505|Diagnostic Test|ELISA|ELISA kit detecting the serum AMH level
15776843|NCT04639505|Diagnostic Test|Chemiluminescence|CLIA method detecting the serum AMH level
15776844|NCT04639492|Dietary Supplement|MBS oral solution|Oral BIDAC, twice a day before breakfast and dinner times
15776845|NCT04639466|Drug|Placebo Administration|Given IM in the non-dominant upper arm
15776847|NCT04639453|Diagnostic Test|Trunk strength with hand-held dynamometer|MicroFET 2 Handheld Dynamometer is a force evaluation testing device to evaluate the strength of various trunk muscle groups in flexion, extension, and lateral (N).
15776848|NCT04639453|Diagnostic Test|Balance Assessment in Sitting and Standing test (BASS)|"The BASS is a test to assess static and dynamic sitting and standing balance, which has been validated for post-stroke hemiparetic patients. Each test is evaluated by a score from 0 (patient needs external support) to 4 (stable without external help) for static condition and from 0 (no possibility to pick up objects) to 3 (objects picked up without external help) for dynamic condition. The maximal score (sitting, standing, static and dynamic) is 14 points."
15776849|NCT04639453|Diagnostic Test|Timed Up and Go test|The participant sits on a chair, gets up, walks 3m, makes a half turn in 1m2, walks 3m and comes back to sit on the chair. The time (s) to complete the task is measured.
15776850|NCT04639453|Diagnostic Test|Modified Functional Reach Test (MFRT)|The MFRT is a dynamic seated balance test that measures the trunk's ability to move forward, to the paretic and non paretic side (cm).
15776851|NCT04639453|Diagnostic Test|Joint Position sense test (trunk)|The joint positional sense test of the trunk consists in evaluating the positional error of the trunk in the sagittal plane (mm) and in the frontal plane (mm) during a trunk flexion posture (target position).
15776852|NCT04639453|Diagnostic Test|Unstable sitting in a seesaw|This test evaluates the balance capacities of the subject in an unstable sitting position on a seesaw (mediolateral or anteroposterior instability) with forceplate and phone application using center of pressure variables: total displacement (mm), area (mm2), deltas (mm), mean velocity (mm/s) et maximal velocity (mm/s).
15776853|NCT04639440|Other|Adipose tissue|Adipose tissue sampling
15776854|NCT04639414|Drug|Empagliflozin 10mg oral tablet / Semaglutide 1mg pen injector|Measurement of the effect of the combined treatment with semaglutide 1mg/week and empagliflozin 10 mg/d compared to matching placebo after 48-week treatment.
15776855|NCT04639414|Drug|Empagliflozin 10mg oral tablet and placebo pen injector matching semaglutide|Measurement of the effect of empagliflozin monotherapy 10mg/d compared to matching placebo after 48-week treatment.
15776856|NCT04639414|Drug|Placebo matching empagliflozin and placebo pen injector matching semaglutide|Measurement of the effect of the combined treatment with semaglutide 1mg/week and empagliflozin 10 mg/d OR empagliflozin monotherapy 10mg/d compared to matching placebo after 48-week treatment.
15776857|NCT04639401|Other|motor entrainment to auditory cues and music during walking on quality of movement|The study contains 1 descriptive and 4 experimental sessions. In the descriptive session, participant's clinical motor and cognitive functions are collected. In the first experimental session, participant's beat perception and synchronisation abilities is examined within a finger tapping paradigm. In the following experimental sessions participants synchronsiation abilities is examined during walking paradigms, to music and metronomes, at different tempi and alignment strategies. In the latter three sessions, apart from outcome measures of synchronization the following will be collected as well: spatio-temporal gait parameters, perceived fatigue, perceived motivation and perceived speed of walking.
15776858|NCT04639388|Behavioral|neuropsychological testing, questionnaires and experimental tasks|Neuropsychological testing (the Sky Search subtest from the Test of Everyday Attention for Children (TEA-Ch); the Overlapping lines task of Rey; auditory attention of NEPSY II battery); questionnaires completed by the children's legal representatives to assess behavior; experimental tasks evaluating gaze direction and facial expression recognition
15776859|NCT04639375|Biological|Vaccinated with polio vaccine (IPV)|poliovirus vaccine (IPV) manufactured by Sanofi Pasteur for distribution in the United States
15776860|NCT04639362|Drug|ibrutinib, venetoclax, obinutuzumab|Patients will receive 3 cycles lead-in with ibrutinib 420 mg/day. Here-after, patients will continue with 13 induction cycles (including one bridging cycle) combining ibrutinib 420 mg/day and venetoclax 400 mg/day (including a ramp up of 5 weeks). Patients who are not in CR or who have detectable MRD after 15 cycles (3 cycles lead-in and 12 cycles induction) will continue with 6 intensification cycles ibrutinib in combination with obinutuzumab day 1, 2, 8, 15 for the first cycle and with obinutuzumab day 1 for the following 5 cycles.
15776861|NCT04639362|Drug|ibrutinib, venetoclax|Patients will receive 3 cycles lead-in with ibrutinib 420 mg/day. Here-after, patients will continue with 13 induction cycles (including one bridging cycle) combining ibrutinib 420 mg/day and venetoclax 400 mg/day (including a ramp up of 5 weeks). Patients who are in CR or have no detectable MRD will be observed.
15776862|NCT04639349|Behavioral|exercise group|the exercise group (20 patients) will receive a exercise session contains a fifty minutes exercise training at home with moderate intensity on the available training devices as bicycle or treadmill in addition to 30 minutes of exercising of upper and lower limb, the session will be repeated three times per week for eight weeks.
15776863|NCT04639349|Other|control group|the control group will not be trained
15776864|NCT04639323|Diagnostic Test|Endoscopic ruler|"Endoscopic ruler for varices in portal hypertension
~Product uses: measuring the diameter of the veins under the endoscopy for the assessment of the risk of variceal haemorrhage in patients with portal hypertension
~Black and white measuring rule is highly recognizable under the endoscopy
~The width of each cell is 1 mm, and the measuring range is 0-10 mm
~With smooth edge, safe and reliable"
15776867|NCT04639297|Device|NeuroVision® IONM|Using NeuroVision® prior to surgery SSEP and tcMEP and values are recorded. A deficit of SSEP tracking is defined as an amplitude reduction of more than 10% or a latency increase more than 50%. Similarly, a CMAP amplitude reduction demonstrates problematic tcMEP monitoring.
15776868|NCT04639297|Device|Hospital Based IONM|Using hospital based IONM prior to surgery SSEP and tcMEP and values are recorded. A deficit of SSEP tracking is defined as an amplitude reduction of more than 10% or a latency increase more than 50%. Similarly, a CMAP amplitude reduction demonstrates problematic tcMEP monitoring.
15776869|NCT04639284|Drug|Anti-angiogenic agents plus anti-PD-1/PD-L1 antibodies|Combination therapies with an anti-angiogenic agent (tyrosine kinase inhibitor or VEGF/VEGFR antibody) and an anti-PD-1/PD-L1 antibody.
15776870|NCT04639271|Drug|Pyrotinib Plus And|Pyrotinib::400mg/d,qd,po
15776871|NCT04639271|Drug|Trastuzumab|8 mg/kg intravenously (IV) on Day 1 of Cycle 1, followed by 6 mg/kg on Day1 of each 21-day cycle
15776872|NCT04639271|Drug|Abraxane|Abraxane 125mg/M2, qw iv
15776874|NCT04639245|Drug|Atezolizumab|Given IV
15776875|NCT04639245|Drug|Cyclophosphamide|Given IV
15776876|NCT04639245|Drug|Fludarabine|Given IV
15776877|NCT04639245|Biological|MAGE-A1-specific T Cell Receptor-transduced Autologous T-cells|Given IV
15776878|NCT04639245|Biological|PD1 Inhibitor|Given IV
15776879|NCT04639232|Dietary Supplement|Placebo|Each participant will consume 6 capsules daily, 2 in every meal, without any restriction in the diet nor in their habits of life.
15776880|NCT04639232|Dietary Supplement|Prob-milk|Each participant will consume 6 capsules daily, 2 in every meal, without any restriction in the diet nor in their habits of life.
15776881|NCT04639232|Dietary Supplement|Voluntas-Prob|Each participant will consume 6 capsules daily, 2 in every meal, without any restriction in the diet nor in their habits of life.
15776883|NCT04639206|Behavioral|HOBSCOTCH|HOBSCOTCH (Home Based Self-management and Cognitive Training Changes lives) is a home-based self-management program to treat cognitive symptoms and improve quality of life while minimizing the barriers of access to care. The program is based on Problem Solving Therapy (PST) and teaches problem solving strategies and compensatory mechanisms to help manage cognitive dysfunction and enhance quality of life. The HOBSCOTCH intervention consists of 8 weekly sessions conducted in-person, over the telephone, or via video-conferencing. A smart phone application will be used to collect data on seizure frequency, medication adherence, and patient engagement.
15776884|NCT04639193|Drug|Acetazolamide|Acetazolamide tablet (encapsulated)
15776885|NCT04639193|Drug|Eszopiclone|Eszopiclone tablet (encapsulated)
15776886|NCT04639193|Drug|Placebo|Sugar capsule manufactured to match encapsulated Acetazolamide/Eszopiclone
15776887|NCT04639193|Drug|Venlafaxine|Venlafaxine capsule
15776888|NCT04639180|Drug|Camrelizumab|Subjects receive Camrelizumab intravenously, Dosage form: lyophilized powder
15776889|NCT04639180|Drug|Rivoceranib (Apatinib)|Subjects receive Rivoceranib (Apatinib) orally, Dosage form: tablet
15776890|NCT04639167|Behavioral|Paths to everyday life (PEER)|The intervention consists of a 10-week group course and the opportunity of individual companionship to e.g. local activities in civil society, municipal social services, education, health and employment. The 10-week group sessions are delivered by two volunteer peers with their own experiential knowledge of mental vulnerability and mental health difficulties. The aim is to form a constructive community through group sessions where exchanges of lived experiences, mutuality and opportunities for social network development can develop.
15776891|NCT04639154|Procedure|Erector spinea plane block|ESPPB will be performed at the T5 and T8 levels of the spine using an in-plane approach. A real-time ultrasound machine will be used to evaluate block performance. A high frequency linear ultrasound probe will be placed longitudinally at a distance of 3 cm from the midline. After identifying the erector spinae muscle and transverse processes, we will insert a 22 G, 100-mm needle after standard skin disinfection. It will be inserted in a caudal-to-cephalad direction using a sterile probe cover until the tip lay in the interfacial plane deep into the erector spinae muscle. This plane will be opened following hydrolocalization with normal saline then 30 mL of 0.25% bupivacaine will be injected slowly, with or without adjuvants, and aspirate every 5 ml to ensure block performance.
15776892|NCT04639141|Combination Product|Synbiotic|Prebiotic + Probiotic
15776893|NCT04639141|Behavioral|Gut-directed Hypnotherapy|Psychotherapy sessions
15776894|NCT04639128|Device|Adductor Canal Catheter|The adductor canal catheter is a medical device that consists of a tunneled catheter connected to an analgesic solution-containing reservoir that slowly infuses the anesthetic over the first 2-3 postoperative days
15776895|NCT04639115|Drug|Ozanimod|Ozanimod
15776896|NCT04639102|Other|PATH Intervention|"Patients will receive an enhanced level of care and service:
~Discharge planning- PATH clinicians will develop an individualized treatment plan at time of ED discharge. Each patient will receive next-day phone call to monitor status. There will be additional patient and family education, triage of new or worsening symptoms, and additional telephone contact as determined in treatment plan. There will be communication with home health teams as needed.
~Care coordination- PATH clinicians will arrange necessary primary medical doctor and specialty appointments. They will also communicate treatment plan to outpatient provider and arrange transportation for patients.
~Home monitoring/ Home Health Services- If patients are eligible and consent to home health services, they will be enrolled in Penn Medicine Home Health (PMHH). This will include virtual home monitoring, skilled nurse care, home physical and occupational therapists, social work services, and wound care."
15776897|NCT04639089|Drug|platlet rich plasma on sternal healing post median sternotomy|"Patient data will be collected preoperatively and intraoperatively and these risk factors will be studied Patients will be distributed to two equal groups. Demographic data : Age - gender - weight - BMI-DM-hist. of radiotherapy exposure -BIMA
~Intraoperative :
~We will apply 10cm plasma contain 1 million platlets on the sternal edge of only one group of them before sternal closure.
~post-operative The patients will be followed till being discharged from hospital and after the first 3 months after surgery"
15776898|NCT04639076|Behavioral|Behavioral Weight Loss Program|The BWL group will receive a standard weight loss intervention based on the evidence-based interventions currently being recommended for clinical practice, with general recommendations for caloric reductions based on starting weight and progressive weekly increases of physical activity (PA). Supporting behavioral lessons based on materials used in the Diabetes Prevention Program (DPP) will also be delivered. The weight loss 'prescription' will remain consistent throughout the 3 month trial. Participants will receive digital tools including a study smart phone app that incorporates diet self-monitoring, tracking of behavioral goals, behavioral lessons and resources, and integration of data from a study-provided Wi-Fi enabled scale and physical activity tracker.
15776970|NCT04638582|Drug|Paclitaxel|Paclitaxel 200 mg/m2 IV every 3 weeks, given on cycle day 1. Only given to participants with squamous cell carcinoma.
15776971|NCT04638582|Drug|Pemetrexed|Pemetrexed 500 mg/m2 every 3 weeks, given on cycle day 1. Only given to participants with non-squamous cell carcinoma.
15778488|NCT04626258|Drug|Fluconazole|Fluconazol once a month 150 mg capsule
15776899|NCT04639076|Behavioral|Personalized Behavioral Weight Loss Program|The PBWL group will receive a calorie goal based on measured resting energy expenditure and baseline PA. In Weeks 1-4, participants will be randomly assigned to test patterns that manipulate diet composition (low-fat or low-carbohydrate), meal frequency (3 or 5-6 meals/day), and PA goals (weekly minutes or daily minutes goals). Following this period, the optimal combination will be identified by the participant and interventionist, based on weight loss, blood glucose, hunger and ability to adhere to the prescription. This group will receive the same supporting behavioral lessons as the BWL group along with additional resources specific to their personalized prescription. The weight loss 'prescription' will vary across the 3-month trial based on response to treatment. Participants will receive the same digital tools as the BWL group with resources specific to following the prescription they are following during any given program week.
15776900|NCT04639063|Other|Microscopic examination using H&E stained slides|Reexamination of the stained slides of the patients from the hospital archive and adding a CD10 stain when required
15776901|NCT04639050|Drug|RO7126209|RO7126209 will be administered via intravenous (IV) infusion, Q4W for a total of seven doses during 28 weeks of treatment.
15776902|NCT04639050|Drug|Placebo|Matching placebo will be administered via IV infusion, Q4W for a total of seven doses during 28 weeks of treatment.
15776903|NCT04639037|Device|Automated adjustment of vasopressor|The objective of this randomized controlled superiority study is to demonstrate that, in patients admitted to intensive care after a major surgery, tight control of MAP using a closed-loop system for vasopressor administration will result in MAP being more often within a MAP range of 80-90 mmHg compared to the same management without this automated closed-loop system (nurse adjustment of vasopressor administration)
15776904|NCT04639037|Device|Manual adjustment of vasopressor|Fluid and vasopressor will be delivered as standard of care (manual adjustment of both fluid and vasopressor infusion rate by the nurse)
15776905|NCT04639024|Drug|ADCT-301|Patients will receive ADCT-301 37.5 ug/kg infused day 1,8, and 15 of a q3week cycle. Patients will have up to 2 cycles to assess response and safety to therapy and if they are not progressing may continue for up to 6 cycles.
15776906|NCT04639011|Drug|Duloxetine|Three doses of 60 mg of oral duloxetine will be given to participants (right before operation, postop day 1, postop day 2)
15776907|NCT04639011|Other|Placebo|Three doses of placebo will be given to participants (right before operation, postop day 1, postop day 2).
15776908|NCT04639011|Other|Standard of care (SOC) for tibial plateau surgery|Postoperative IV administration of opioids via a patient controlled analgesia (PCA) system which utilizes a hydromorphone pump.
15776909|NCT04638998|Procedure|Magnetic Resonance Spectroscopic Imaging|MRSI is a non invasive imaging technique used to detect neuroinflammation.
15776910|NCT04638998|Procedure|Blood draw|Blood will be drawn to assess systemic inflammation in Gulf War verterans.
15776911|NCT04638985|Biological|sIPV+DTaP+MMR|sIPV+DTaP+MMR at the age of 18 month old
15776912|NCT04638985|Biological|sIPV|sIPV at the age of 18 month old
15776913|NCT04638985|Biological|DTaP|DTaP at the age of 18 month old
15776914|NCT04638985|Biological|MMR|MMR at the age of 18 month old
15776915|NCT04638972|Device|working length determination techniques|A total of 30 infected mandibular primary second molar teeth in twelve children aged between 5 and 8 years were included in this study. Working length determination was performed using tactile sense, radiographic method and two different varieties of electronic apex locators (ProPex Pixi® and Ipex®) separately.
15776916|NCT04638959|Other|collect gastric tissue and stool samples|collect gastric tissue and stool samples
15776917|NCT04638946|Behavioral|Titration to high intensity exercise (T-HIE)|All participants will receive psychoeducation regarding the rationale for using exercise as a strategy to create immediate changes in mood and anxiety. Participants will be instructed in basic motivational principles (e.g., breaking up goals into smaller parts, using rewards) based on information in Exercise for Mood and Anxiety. Participants will begin at low intensity with the goal of titrating to high intensity by 2 weeks prior to the end of trial (Week 6). If a participant achieves at least 70% of the duration goal at the target heart rate, he/she will be titrated to the next dose level (moderate intensity). This will continue until high intensity exercise is achieved. Prescription is based on heart rate reserve((maximum heart rate [220-age] - resting heart rate)*intensity percent - resting heart rate. Intensity percent lower/upper limits for moderate intensity are 40-59% and for high intensity are 60-84%.
15776918|NCT04638946|Behavioral|Low intensity exercise prescription|All participants will receive psychoeducation regarding the rationale for using exercise as a strategy to create immediate changes in mood and anxiety. Participants will be instructed in basic motivational principles (e.g., breaking up goals into smaller parts, using rewards) based on information in Exercise for Mood and Anxiety. Prescription is based on heart rate reserve ((maximum heart rate [220-age] - resting heart rate)*30-39% (lower/upper limit of zone) - resting heart rate.
15776919|NCT04638933|Other|No intervention|No intervention
15776920|NCT04638920|Other|No intervention|No intervention
15776921|NCT04638907|Procedure|Assessment of NM block|Observation of resulting course of NM block under teratment and monitoring as described.
15776922|NCT04638894|Procedure|Surgical treatment of patients with adult spinal deformity|Including all surgical interventions for patients with adult spinal deformity.
15776923|NCT04638881|Drug|Magnesium sulfate|Magnesium infusion 50 mg/kg bolus over 15 minutes and 25 mg/kg/hr infusion, both administered intraoperatively under general anesthesia.
15776924|NCT04638881|Drug|Normal Saline|Placebo. Bolus and infusion administered similarly under general anesthesia.
15776925|NCT04638868|Device|Microsieve device|Both portal venous and peripheral blood will be processed through a label-free size-based silicon microsieve microfiltration device, which will isolate both epithelial-type and mesenchymal-type pancreatic cancer circulating tumor cells. Downstream mutational analyses will be performed to confirm identity of the cells.
15776926|NCT04638868|Device|Cell surface marker-based platform|Both portal venous and peripheral blood will be processed through a cell surface marker-based platform, which contains antibodies for epithelial cell markers on pancreatic cancer circulating tumor cells. Downstream mutational analyses will be performed to confirm identity of the cells.
15776927|NCT04638855|Device|Medicurtain®|Anti-adhesion barrier (Medicurtain® 5ml prefilled syringe after hysteroscopy surgery)
15776928|NCT04638855|Device|Placebo|No device after hysteroscopy surgery
15850665|NCT04037631|Diagnostic Test|Diagnostic device|Diagnostic test
15776929|NCT04638842|Behavioral|Online Intervention Grief COVID-19|The online Intervention Grief COVID-19 aims to provide to the target population a self-applied intervention based on Cognitive Behavioral Therapy, Mindfulness, Behavioral Activation Therapy, and Positive Psychology, aimed at the Psychoeducation regarding the manifestations of normal grief, advice and guidance on how to find emotional relief, with the aim that survivors allow themselves to validate their experience of emotional pain and recognize it as a normal part of their process of adaptation to loss, what does grief deprived of rights consist of, specifically from the contingency of COVID-19, establish self-care measures for people in different areas of their life (physical, emotional, cognitive and spiritual), direct the survivor to relocate the died in his life without his memory causing suffering, in addition to beginning to resume his life project, adjusting according to his needs and goals. The sessions will be delivered in a frequency of one session every three days.
15776930|NCT04638829|Drug|Avatrombopag Oral Tablet|Avatrombopag 20 mg given daily for 90 days. Initial dose and dose adjustments will be determined by the physician along with the Doptelet prescribing information
15776931|NCT04638816|Device|Restylane Volyme|Hyaluronic Acid: Injectable gel for contouring effect (of cheek volumization).
15776932|NCT04638816|Device|Restylane Lyft Lidocaine|Hyaluronic Acid: Injectable gel for projection effect (of cheek augmentation).
15776933|NCT04638803|Drug|PRX-P4-003, (-)-FCF|sequential study
15776934|NCT04638790|Drug|Doxorubicin|25 mg/m2 i.v. day 1,15 for ABVD/AVD
15776935|NCT04638790|Drug|Bleomycin|10,000 units/m2 i.v. days 1,15 for ABVD
15776936|NCT04638790|Drug|Vinblastine|6 mg/m2 i.v. days 1,15 for ABVD/AVD
15776937|NCT04638790|Drug|Dacarbazine|375 mg/m2 i.v. days 1,15 for ABVD/AVD
15776938|NCT04638790|Drug|Etoposide|100 mg/m2 i.v. days 1-3
15776939|NCT04638790|Drug|Doxorubicin|50 mg/m2 i.v. day 1 for EACODD-14
15776940|NCT04638790|Drug|Cyclophosphamide|650 mg/m2 i.v. day 1
15776941|NCT04638790|Drug|Vincristine|1,4 mg/m2 i.v. day 8
15776942|NCT04638790|Drug|Dexamethasone|20 mg i.v. days 1-3
15776943|NCT04638790|Drug|Dacarbazine|375 mg/m2 i.v. day 1 for EACODD-14
15776944|NCT04638777|Device|rTMS with H-coil|Real repetitive transcranial magnetic stimulation with H-coil over M1 and PFC
15776945|NCT04638777|Device|rTMS with H-coil|Real repetitive transcranial magnetic stimulation with H-coil over M1 and sham repetitive transcranial magnetic stimulation with H-coil over PFC
15776946|NCT04638777|Device|rTMS with H-coil|Sham repetitive transcranial magnetic stimulation with H-coil over M1 and PFC
15776947|NCT04638764|Other|Aerobic interval training combined with high intensity resistance training|Patients enrolled in arm of the study will perform 12 weeks of combined aerobic interval training (5 intervals of cycling at the intensity of 50 %-80% of peak power obtained at baseline cardiopulmonary testing) combined with high intensity resistance training (3 sets of leg press at the intensity of 70 %- 80 % of one repetition maximum (1-RM)).
15776948|NCT04638764|Other|Aerobic interval training combined with low intensity resistance training|Patients enrolled in arm of the study will perform 12 weeks of combined aerobic interval training (5 intervals of cycling at the intensity of 50 %-80% of peak power obtained at baseline cardiopulmonary testing) combined with high intensity resistance training (3 sets of leg press at the intensity of 30 %- 40 % 1-RM).
15776949|NCT04638764|Other|Aerobic interval training|Patients enrolled in arm of the study will perform 12 weeks of aerobic interval training (5 intervals of cycling at the intensity of 50 %-80% of peak power obtained at baseline cardiopulmonary testing).
15776950|NCT04638751|Drug|Immunotherapy|Use of any checkpoint inhibitor to treat a patient that is previously naive to immunotherapy
15776951|NCT04638751|Drug|Chemotherapeutic Agent|Any type of cancer chemotherapy that the patient has not yet been exposed to
15776952|NCT04638738|Device|SensiumVitals wearable patch sensor|Wearable sensor which measures heart rate, respiratory rate, and temperature continuously.
15776953|NCT04638725|Other|Blood sample for genetic analysis|Blood samples will be collected in two 6 ml EDTA tubes after informed consent and inclusion in the study
15776954|NCT04638712|Other|Microbiopsy sample|before and after chemotherapy
15776955|NCT04638712|Other|Muscle echography, Maximal strength, Body composition, Quality of life and Physical activity level|before and after chemotherapy
15776956|NCT04638699|Other|OptiScreen training|Special psycho-oncological training for nursing staff to acquire basic knowledge about the experience of mental stress as well as diagnostics of psychosocial stress
15776957|NCT04638686|Drug|Dolutegravir 50 MG|The subjects started their antiretroviral treatment containing dolutegravir once a day.
15776958|NCT04638686|Drug|Lamivudine 300 MG|The subjects started their antiretroviral treatment containing lamivudine once a day
15776959|NCT04638673|Device|Soterix taVNS model 0125-LTE Stimulator - Active-Active Group|Participants will receive active taVNS stimulation for weeks 1-4 of the stimulation portion of this study.
15776960|NCT04638673|Device|Soterix taVNS model 0125-LTE Stimulator - Sham-Active Group|Participants will receive sham taVNS stimulation for weeks 1&2 and active stimulation for weeks 3&4 of the stimulation portion of this study.
15776961|NCT04638660|Drug|Phentolamine Ophthalmic Solution 0.75%|0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
15776962|NCT04638660|Drug|Phentolamine Ophthalmic Solution Vehicle (Placebo)|Topical sterile ophthalmic solution
15776963|NCT04638647|Biological|Secukinumab s.c. injection|Secukinumab pre-filled syringes (PFS) for s.c. injection
15776964|NCT04638634|Biological|CSL760|An Intravenous Anti-SARS-CoV-2 Hyperimmune Globulin
15776965|NCT04638608|Other|EMBRACE (relatives)|Online support program for both relatives
15776966|NCT04638608|Other|EMBRACE (Health care providers)|Online support program for health care providers
15776967|NCT04638595|Other|Observation|This project seeks to recruit 25 male and 25 female typically developing children between the ages of 3 and 18 years of age. Non-invasive measurements of movement patterns will be collected during common activities of daily living over a single data collection session.
15776968|NCT04638582|Drug|Pembrolizumab|Neoadjuvant pembrolizumab 200 mg IV every 3 weeks, given on cycle day 1. Adjuvant pembrolizumab 400 mg IV every 6 weeks, given on cycle day 1.
15776969|NCT04638582|Drug|Carboplatin|Carboplatin AUC 6 IV (maximum dose: 900 mg) for squamous cell carcinoma, and AUC 5 IV (maximum dose: 750 mg) for non-squamous cell carcinoma, every 3 weeks, given on cycle day 1.
15850666|NCT04037618|Drug|[14C]-EYP001a|Oral drinking suspension
15776972|NCT04638569|Procedure|obturator nerve block|The ultrasound probe will be placed in the middle of the tuberculum pubis and femoral artery, 5-6 cm below the inguinal ligament, and 5 mL of 0.5% bupivacaine will be injected into the anterior and posterior branches of the ON with a needle. In the second group, after the patient is placed in the lithotomy position, 1.5 cm lateral tuberculum pubis and 1.5 cm caudal will be marked and needle entry will be made and 0.5% bupivacaine will be injected with 10 mL. The time elapsed until the first needle insertion and local anesthetic injection is completed will be recorded as the application time.
15776973|NCT04638556|Diagnostic Test|lncRNA detection|The lncRNAs in the plasma of three groups of patients will be tested.
15776974|NCT04638543|Drug|ABP-671|ABP-671 Tablet
15776975|NCT04638543|Drug|Placebo|Placebo
15776976|NCT04638530|Other|Education on breaking bad news to family members remotely|Participants will receive a combination of surveys, pre- and post-tests, lectures and didactics to increase their awareness of techniques to communicate difficult topics with patients remotely as well as skill building exercises.
15776977|NCT04638517|Drug|Danazol|Danazol up to 800mg daily in two-divided doses.
15776978|NCT04638517|Drug|Placebo|Matching placebo.
15776979|NCT04638504|Other|ultrasonography|vascular and adipose tissue measurement by ultrasonography
15776980|NCT04638491|Drug|Lurbinectedin for injection|On the first day of each cycle, patients with advancedsolid tumors or small cell lung cancer were treated with Lurbinectedin for injection
15776981|NCT04638478|Other|PRECODE-MRI|Patients with meningioma WHO I tumours treated with radiotherapy will be included, undergoing extensive cognitive testing combined with advanced brain MRI scans just before, 3 and 24 months after radiotherapy
15776982|NCT04638465|Procedure|Transoral robotic surgery|Transoral resection with neck dissection
15776983|NCT04638465|Drug|Cisplatin - Dose Level 1|6 Cycles of 40 mg/m2
15776984|NCT04638465|Drug|Cisplatin - Dose Level 2|7 Cycles of 40 mg/m2
15776985|NCT04638465|Radiation|Dose Level 1|60 Gy/6 weeks - 2 Gy/fraction, 5 fractions/week
15776986|NCT04638465|Radiation|Dose Level 2|70 Gy/7 weeks - 2 Gy/fraction, 5 fractions/week
15776987|NCT04638452|Behavioral|Video & movements recording|Video recording of face, body movements and physiological parameters (heart rate, conductance using a wireless watch) of the participants during the blood test
15776988|NCT04638452|Behavioral|Questionnaires|Passing self and hetero questionnaires of emotion felt and perceived.
15776989|NCT04638439|Drug|P1101 + Nivolumab + Entecavir|"P1101 (Ropeginterferon alfa-2b) 450 µg subcutaneously (SC) Q2W for 6 doses (12 weeks) *, followed by 0.3 mg/kg Nivolumab for 6 doses (12 weeks) **, with a follow up of 24 weeks. All patients will also receive Entecavir 0.5 mg QD from Day 1 to Follow-up 24.
~*: HBsAg will be checked at treatment week 12 (or 16, if applicable).
~**: Only patients with > 0.5 log10 decline in HBsAg at treatment week 12 or 16 will be sequentially treated with Anti-PD1."
15776990|NCT04638426|Drug|HL237 tablet|Treatment A : HL237 100mg, twice a day, Treatment B : HL237 200mg, twice a day, Treatment C : HL237 400mg, twice a day
15776991|NCT04638426|Drug|Placebo of HL237 tablet|Placebo of HL237, twice a day
15776992|NCT04638413|Behavioral|Walking (W)|Participants engage in daily walking for a 3 week period.
15776993|NCT04638413|Behavioral|Gamified inhibitory control training (PolyRules!)|Participants engage in daily gamified inhibitory control training for a 3 week period.
15776994|NCT04638413|Behavioral|Walking + PolyRules! (W+PolyRules!)|Participants engage in daily walking and gamified inhibitory control training for a 3 week period.
15776995|NCT04638400|Drug|Simvastatin 40mg|Simvastatin administered daily for 6 weeks
15776996|NCT04638400|Drug|Ezetimibe 10mg|Ezetimibe administered daily for 6 weeks
15776997|NCT04638387|Dietary Supplement|PB125|Nrf2 activator containing active ingredients carnosol, withaferin A, and luteolin.
15776998|NCT04638387|Dietary Supplement|Placebo|Placebo comparator to P125
15776999|NCT04638361|Other|Questionnaires|To explore the quality of life, two questionnaires will be submitted to the parents and the child. The first one is the pediatric version of the VHI (Voice Handicap Index), which explore, using 23 items, the functional, physical and emotional aspects of the dysphonia. The second one is the PEDI-EAT-10 (Pediatric Voice Handicap Index - Eating Assessment Tool), which explore, through 10 items (ranging from 0 to 4), the risk of aspiration and assess the impact of possible dysphagia on quality of life.
15777000|NCT04638348|Device|New Biofeedback|Conventional biofeedback consists of a electromyography biofeedback device with a vaginal probe.
15777001|NCT04638335|Biological|Blood test|blood test for Anti-HAV antibodies
15777002|NCT04638322|Other|HIFT Group|An experimental group (EG) that after an initial evaluation will be subjected to a physical training program based on the HIFT method, for 12 weeks with 2 weekly sessions (Tuesday and Thursday), with a duration of 45 min per session. Once the intervention is finished, you will undergo a final evaluation to see if there is a difference or not with the results obtained at the beginning.
15777003|NCT04638309|Drug|APR-548 + Azacitidine|APR-548 monotherapy period followed by APR-548 in combination with Azacitidine
15777004|NCT04638296|Other|Interviews|The investigators designed 3 versions of the semi structured interview guide for each of the surgeons/anesthesiologists (Appendix A.1), residents (Appendix A.2) and nurses (Appendix A. 3). All versions were subdivided into 3 general categories: 1) participant demographics such as participant's age, years of experience, specialty, years of employment at the institution 2) participant's perceptions of noise in the OR, what they considered as sources of noise, the loudness level, whether they thought this impacted their concentration, performance, communication, whether this was distracting or helpful in different stages of the operation, and 3) perceptions on music.
15777005|NCT04638283|Behavioral|Goal Attainment Scaling|Individual goals will be formulated and measured by Goal Attainment Scaling (GAS). GAS provides a method for quantifying the attainment of individualized goals, typically set in cognitive rehabilitation. Different levels of outcomes for each goal are operationalized in a five-point scale and given a numeric value. For each individual goal, minus two refers to the goal attainment much less than expected, minus one refers to a little less than expected, zero refers to expected outcome, plus one refers to a little bit better than expected and plus two refers to goal attainment much better than expected. The participants can establish as many goals as desired. Outcomes can be summed within different patient goals, as well as across patients to assess overall outcome of treatment outcomes.
15777095|NCT04637451|Procedure|Root coverage treatment|Gingival unit graft Connective tissue graft
15777006|NCT04638270|Biological|anti-CD19 FasT CAR-T cells|Treatment follows a lymphodepletion, chemotherapy regimen that consists of Fludarabine (30 mg/m2 per day) and Cyclophosphamide (500mg/m2 per day) for 3 days prior to cell infusion.
15777007|NCT04638257|Biological|Lactobacilli rhamnosus GR-1 and Lactobacilli fermentum RC-14|Daily oral Lactobacilli starting at =<18 weeks of gestation in singleton pregnancy
15777008|NCT04638257|Other|Placebo|Daily oral placebo starting at =<18 weeks of gestation in singleton pregnancy
15777009|NCT04638244|Behavioral|Music|Brief Online Music
15777010|NCT04638244|Behavioral|Reading messages|Reading psychoeducational messages
15777011|NCT04638231|Other|Supportive messages|Daily supportive messages via SMS or email
15777012|NCT04638218|Device|Rehabilitation Training System|The system can capture useful biomechanical data accurately, such as the location of body centre of mass (COM), the body joint angles, and the body posture. These useful data are stored in a database and can be conveniently accessed by the therapists, which facilitate the follow-up of the patients' therapeutic progress.
15777013|NCT04638192|Device|tACS|A pair of 25 cm2 rubber electrodes enclosed in saline-soaked sponges and affixed to the head with rubber bands.
15777014|NCT04638179|Other|Not intervention.Use retrospective case contrl study.|Use retrospective case contrl study.
15777015|NCT04638166|Other|Mineral water|Drinking mineral water for 12 weeks
15777016|NCT04638166|Other|Plain water|Drinking plain water for 12 weeks
15777017|NCT04638153|Biological|Recifercept|Recifercept
15777018|NCT04638127|Behavioral|PREEMIE PROGRESS|PREEMIE PROGRESS is a video-based training program for parents of preterm infants hospitalized in the neonatal intensive care unit (NICU).
15777019|NCT04638127|Behavioral|Attention Control|usual care and welcome videos
15777020|NCT04638114|Procedure|Mini-open DAA|Direct anterior approach hip
15777021|NCT04638114|Procedure|Hip arthroscopy|arthroscopic treatment of hip pathology
15777022|NCT04638101|Behavioral|Mindfulness-based intervention|Mindfulness-based intervention: The proposed MBI was designed based on well-known MBI programs including Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy and adapted to adolescents' needs and language. The program consisted of 8 weekly sessions in groups of up to 8 participants, lasting 1h30. Two MBI groups were offered per week (Wednesdays and Fridays) and participants had the possibility to choose the most convenient day for them. Two instructors were present for each group throughout the intervention.For each session one theme was addressed, such as attention and the stabilisation of the focus of attention, bodily sensations, breath, emotions, thoughts, compassion, stress, stress reactivity and coping strategies.
15777023|NCT04638088|Other|assessment of urinary function and erectil function before and after prostatectomy|assessment of urinary function and erectil function before and after prostatectomy performed by robot assisted or conventional laparoscopy or laparotomy will complete
15777024|NCT04638075|Device|Supplemental Nursing System|The SNS is a device designed to deliver supplemental milk by suckling at the mother's nipple. A specially designed bottle attaches to the mother's breast and serves as the reservoir for milk. Attached to the bottle is a small tube which runs down to and is placed on the tip of the mother's nipple. With an adequate latch the neonate obtains supplementation by suckling. Additionally, this suckling stimulates milk production (Lawrence & Lawrence, 2016).
15777025|NCT04638062|Other|1.Post Isometric Relaxation|"For Upper Trapezius In supine position Neck flexion, contra-lateral full side bending followed by slight ipsilateral rotation will be provided towards the side being treated. while asking the patient to shrug the stabilized shoulder and contraction will be maintained for 7- 10s. Repeating it 3-5 times.
~For Levator Scapulae Step One In supine position while lifting the patients neck in full flexion, lateral flexion and rotation with 7-10s isometric contraction away from side to be treated will be provided.
~Step Two The patient will be instructed to take head backwards to the table while at the same time asking the patient to slightly shrug the shoulder and resistance will be provided. Repeating it 3-5 times.
~2.Neck isometric strengthening exercises Intensity 5 reps Frequency at 1st week one set and second week will progress to 2 sets
~3.Cryotherapy will be placed on cervical region for 10 min after the treatment."
15777026|NCT04638062|Other|1.Myofascial Release therapy|"For Upper Trapezius In sitting position Myofascial Release of Trapezius will be performed unilaterally with soft fist or elbow sinking and then taking up the line of tension from mid belly of Trapezius, to the acromion process, while the patient drops the head forward and will slowly rotate the head from side to side. While providing the resistance to contralateral side of rotation. Repeating for 2-3 times.
~For Levator Scapulae In sitting position applying same unilateral muscle release as Trapezius, but the line of tension will be to the inferior border of Scapulae slightly laterally and will ask the patient to drop the head forward to increase resistance on Levator muscle. Repeating it 2-3 times
~2.Neck isometric strengthening exercises Intensity 5 reps Frequency at 1st week one set and second week will progress to 2 sets
~3.Cryotherapy will be placed on cervical region for 10 min after the treatment."
15777027|NCT04638049|Other|Collection of human biofluids|Feces, blood and urine: (1) shortly before, (2) during and (3) shortly after RT treatment, as well as (4) one-month post-RT
15777028|NCT04638049|Other|Patient reported outcome measures|EORTC QLQ-C30, PR25: (1) shortly before and (2) shortly after RT treatment, as well as (3) one-month post-RT
15777029|NCT04638036|Drug|Cetuximab-IRDye800|Intravenous administration of a pre-dose of 75 mg unlabeled Cetuximab followed by 15 mg Cetuximab-IRDye800 prior to the study procedures
15777030|NCT04638036|Device|Fluorescent molecular endoscopy and surgery|A flexible fluorescence fiber-bundle is attached to a fluorescence camera platform to enable the detection of fluorescence signals. The fluorescence fiber-probe can be inserted through the standard working channel of the standard clinical endoscope for fluorescent endoscopy. Fluorescence imaging will be performed post the chemoradiotherapy.
15777031|NCT04638023|Device|Arabin pessary|Arabin pessary was inserted intravaginally electively in women with cervical insufficiency (history based) or as emergency in those with short cervix on ultrasound.
15777032|NCT04638010|Behavioral|Cancer control navigation (CNN)|Cancer Control Navigators (CNNs) housed at 2-1-1 call centers aid callers. CNNs receive electronic summary profiles of participants assigned to navigation. Navigators call the participant, build a collaborative relationship with them, identify their needs, work with them to identify barriers to services and coordinate solutions, and provide logistic (e.g., making appointments) and emotional support. Navigation services are provided by telephone only.
15777096|NCT04637438|Other|Fecal Microbiota Transplantation|FMT via colonoscopy
15777033|NCT04638010|Behavioral|General referral (usual care)|Information Specialists at the 2-1-1 call center provide cancer control referrals specific to participant's screening or prevention needs.
15777034|NCT04637997|Device|compression stockings class I|Daily wearing of compression stockings class I for four weeks on the affected extremity.
15777035|NCT04637997|Device|compression stockings class II|Daily wearing of compression stockings class II for four weeks on the affected extremity.
15777036|NCT04637984|Behavioral|PREP2 algorithm|A) PREP2. It combines clinical measures and neurological biomarkers in the initial days after stroke: 1) SAFE score (day 3), which is the sum of shoulder abduction and finger extension strength in the paretic upper limb using the Medical Research Council (MRC); 2) NIH Stroke Scale (day 3); 3) transcranial magnetic stimulation (day 3-7) to determine the presence of MEPs in the paretic arm. According with the aforementioned measures, 4 categories of upper limb recovery will be identified: EXCELLENT, GOOD, LIMITED and POOR.
15777037|NCT04637971|Other|Coaching|Participants will receive 4 sessions of group coaching intervention within 6 weeks. Each session is in a group of 3-4 women and lasts for approximately 1.5 hours. The sessions will be conducted by experienced social workers.
15777038|NCT04637971|Other|Self-help tips plus telephone support|Participants will receive 4 self-help tips sent via SMS and 4 phone call from a social worker in 6-week of time. During the telephone call, the social worker will advise the client to make use of the tips we sent to her.
15777039|NCT04637958|Device|THA|Total hip arthroplasty
15777040|NCT04637945|Dietary Supplement|ACRB|Product will be consumed once daily, preferably with breakfast.
15777041|NCT04637945|Other|Placebo|Product will be consumed once daily, preferably with breakfast.
15777042|NCT04637932|Procedure|Percutaneous Dilatation Tracheostomy|pro-seal laryngeal mask or intubation tube in bronchoscopy-guided percutaneous dilation tracheostomy procedure.
15777043|NCT04637919|Biological|IN-B001 EV71 A dose|Inactivated vaccine against EV71, three doses, 28 days interval
15777044|NCT04637919|Biological|IN-B001 CVA16 B dose|Inactivated vaccine against CVA16, three doses, 28 days interval
15777045|NCT04637919|Biological|IN-B001 Bivalent C dose|Inactivated vaccine against EV71/CVA16, three doses, 28 days interval
15777046|NCT04637919|Biological|Placebo|Placebo, three doses, 28 days interval
15777047|NCT04637906|Dietary Supplement|Bioarginina®|Food supplement based on 1,66 grams of L-arginine
15777048|NCT04637893|Other|Colonoscopy|Pt. underwent colonoscopy
15777049|NCT04637867|Other|Collection of blood, salivary and nasopharyngeal samples.|"Each visit M6 and M12
~Blood: 1 PAXgene tube (2.5mL) 1 EDTA tube (4mL), 1 dry tube with gel (5mL), 3 EDTA tubes (10mL each)
~Salivary sample
~Nasopharyngeal sample"
15777050|NCT04637854|Procedure|Operating microscope|Third molar extraction using microscope
15777051|NCT04637854|Procedure|Surgical loupes|Third molar extraction using loupes with co-axial illumination
15777052|NCT04637854|Procedure|Naked eyes|Third molar extraction using naked eyes
15777053|NCT04637841|Other|Kinesiology Taping Appliying|"Kinesiology tape will be applied to left foot plantar fascia of the participants in diabetes mellitus and control group.
~During taping, participants will lie in the prone position while the knee joint will be kept 90 degrees of flexion and the ankle joint in a neutral position. A Palm Shape taping procedure will be applied to the plantar fascia."
15777054|NCT04637841|Other|Myofascial Release Technique Appliying|"Myofascial release technique will be applied (during 5 minutes) to right foot plantar fascia of the participants in diabetes mellitus and control group
~During appliying technique, participants will lie in the prone position while the knee joint will be kept 90 degrees of flexion and the ankle joint in a neutral position."
15777055|NCT04637828|Drug|GNS561|study drug
15777056|NCT04637815|Behavioral|Motivational Network Intervention|See earlier description
15777057|NCT04637815|Other|Usual Care|See earlier description
15777058|NCT04637802|Behavioral|CBT (SurgeryPal)|The SurgeryPal intervention is a cognitive-behavioral program for youth undergoing major surgery. SurgeryPal is delivered in two 4-week phases: the pre-operative phase, and the post-operative phase. Each phase consists of 3 separate treatment modules for youth and parents, which teach cognitive and behavioral coping skills to target known psychosocial and behavioral risk factors (i.e. anxiety/distress and sleep disturbance) for poorer postsurgical outcomes, and provide training in pain self-management skills. Pre-operative modules include: 1) Preparing for surgery, 2) Coping with stress before surgery, and 3) Getting ready for the hospital. Postoperative modules include: 1) Coping at home after surgery, 2) Return to activities and school, and 3) Long-term recovery. Modules are self-guided and interactive, and focus on phases of preparation and recovery from surgery. The goal of the program is to reduce pain and enhance quality of life following surgery in youth.
15777059|NCT04637802|Behavioral|Education|The patient education website will serve as the active comparator. The purpose is to control for time, attention, and online usage. Youth and parents will be provided access to an education website containing information about pediatric surgery at the same time interval as the active intervention; however, there will be no exposure to cognitive and behavioral coping skills. Similar to the CBT condition, the presurgery period of Education will be administered for one month prior to surgery and the postsurgery period will be administered for one month after the post-discharge assessment.
15777060|NCT04637789|Behavioral|the whole body vibration|most people stand on the platform with knees bent at about a 30-degree angle, while the surface beneath their feet vibrates an astounding 30 times per second.
15777061|NCT04637789|Behavioral|resistance training|Resistance training is a form of exercise that improves muscular strength and endurance. During a resistance training workout, you move your limbs against resistance provided by your body weight, gravity,bands, weighted bars or dumbbells.
15777062|NCT04637776|Other|Hospitalization|Hospitalization for any reason
15777097|NCT04637438|Other|Placebo|Water infusion via colonoscopy
15777129|NCT04637061|Diagnostic Test|Evaluation of the anastomotic rings|The assessment of the anastomotic rings following mechanical anastomosis will be recorded as complete/incomplete
15777130|NCT04637035|Other|Supportive Oncology Care at Home|Intervention entailing remote monitoring of patients' symptoms, vital signs, and body weight with home-based care.
15777066|NCT04637750|Behavioral|Educational intervention|The GPs randomized to the intervention arm will receive a feedback informing on their absolute number of patients treated with at least one PPI during the baseline period and if they have been prescribed above or below the median of appropriate prescriptions rate in their local area. They will be also provided with a scientific document including technical details on AIFA reimbursement criteria (NOTA 1 and 48), short hints about adverse events related to PPI long- term use in older patients and recommendation on how to discontinue PPI therapy (i.e. gradual step down administration to avoid paradoxical effect).
15777067|NCT04637737|Device|anterioposterior Weight Shifting Training with Visual Biofeedback|"The training group received an additional anterioposterior weight shifting training with visual Biofeedback 5 times per week for 4weeks. AP training is made to instantly know your training status during training by measuring and processing the foot pressure in real time using the F-Scan (Tekscan) hardware system and Software Development Kit (SDK).
~Before training, all patients are instructed to place both feet at shoulder width, place the inverted foot approximately 30 cm in front of the unaffected side foot, move the body forward with the chest straight in an upright position, and be instructed to put the weight on the affected side.
~On the screen shown, measure the maximum weight distribution during the first 10 times and set the value added by 5% as the target value.
~It is designed to induce the maximum weight shift through the archery game."
15777068|NCT04637737|Behavioral|Conventional therapy|The control group received the usual gait training.
15777069|NCT04637724|Device|transcranial direct current stimulation (tDCS)|10 sessions of Anodal tDCS of the dorsolateral prefrontal cortex over a period of 5 consecutive days (two session a day). Each session includes the placement of two tDCS electrodes (anodal at left prefrontal area and cathodal above the vertex) and 20 mins of anodal prefrontal stimulation. The tDCS session is received two time a day with a 3-5 hours interveal betwen sessions.
15777070|NCT04637711|Procedure|Focus clearing + whole breast exploration and washing + one-stage micro plastic surgery No Intervention: Extensive lesion excision|Only visible lesions and necrotic tissues, such as abscess cavity, sinus tract and fistula, were removed intraoperatively, while normal glands and fat were retained. Preoperative ultrasound was used to locate the lesion area and then the surgical incision was designed. Intraoperative ultrasound examination of latent small lesions, resection of lesions visible under ultrasound, and then a full breast exploration, one finger page incision interval.Radially cut from the base to the subcutaneous, lesions were found and treated locally. After removal of lesion, fully using the syringe, in turn, use of 3% hydrogen peroxide solution, 1% eniodine, saline water is widely jet pulse washing, and around the lesions base. After rinsing, soak in 1% active iodine for 10min, then rinse with normal saline until the liquid is clear. Breast tumor Surgery (Oncoplastic Breast Surgery, OBS) core technology (volume replacement and volume replacement).
15777071|NCT04637698|Biological|OH2 injection|Oncolytic Type 2 Herpes Simplex Virus
15777072|NCT04637685|Device|Centurion Phacoemulsification System|Infusion Pressure
15777073|NCT04637659|Procedure|Root Canal Treatment|Chemo-mechanical preparation will be performed using reciprocating instruments . Irrigation will be carried out with 5.25% NaOCl during instrumentation and a final flush of 17% EDTA followed by 5.25% NaOCl. After drying with paper points, canal obturation will be achieved through continuous condensation wave technique. Obturation with gutta-percha will be performed using Reciproc blue R25 master cones and root canal sealer using the BeeFill 2 in 1 device (VDW, GmbH) with a small heat carrier (#40 tip size and .03 taper) following the manufacturer's instructions. After the down-packing phase, the back-filling will be performed with the same device and manual compaction using endodontic pluggers.
15777074|NCT04637633|Drug|topical 0.05% CsA (Restasis®, Allergan Inc, Irvine, California)twice daily dose,|topical preservative free artificial tears Q.I. D.
15777075|NCT04637620|Drug|NMDAE|Use of an NMDA enhancer for the treatment of MDD
15777076|NCT04637620|Drug|Sertraline|Use of SSRI as an active comparator
15777077|NCT04637620|Drug|Placebo Cap|Use of placebo as a comparator
15777078|NCT04637607|Other|Auricular acupoints stimulation|Noninvasive auricular acupoints stimulation with seeds
15777079|NCT04637594|Drug|Pembrolizumab|Given IV
15777080|NCT04637594|Drug|Nivolumab|Given IV
15777081|NCT04637594|Drug|Atezolizumab|Given IV
15777082|NCT04637594|Drug|Durvalumab|Given IV
15777083|NCT04637594|Drug|Avelumab|Given IV
15777084|NCT04637581|Behavioral|Wraparound|Wraparound is a 12-month family-driven intensive care coordination model.
15777085|NCT04637568|Diagnostic Test|Computerized tomography|Obtained CT scans involving the head region were analyzed retrospectively.
15777086|NCT04637555|Drug|sacubitril/valsartan|LCZ696 (sacubitril/valsartan) tablet will be available in 24/26 mg, 49/51 mg and 97/103 mg, respectively
15777087|NCT04637542|Other|Mobile Learning|"The necessary interviews and correspondences were carried out in order to conduct the research. Permission was obtained from Health Sciences University Istanbul Training and Research Hospital Clinical Research Ethics Committee. The purpose of the study was explained to the students as per the sample criteria and their consents were obtained. All of the students participating in the study attended four hours of theoretical lessons in the classroom related to anatomy of the genital system. Following the theoretical training, students were divided into experiment (mobile application) and control (genital organ model) groups. Both groups where then given the Structured Student Presentation Form, Status and trait anxiety inventory and Knowledge Examination (pre-test) on paper.
~The didactic content prepared for the institution's standard curriculum (control group) or mobile learning is similar for both training methods."
15777088|NCT04637529|Drug|S (+) - Ibuprofen|S (+) - Ibuprofen + placebo of Ibuvix®
15777089|NCT04637529|Drug|Ibuvix® - ibuprofen|Ibuvix® + placebo of S(+) - Ibuprofen
15777090|NCT04637516|Device|"Animation program BlinkBlink"|Computer program that presents horizontal bars on the computer screen that move from above and below towards each other, mimicking a blink movement.
15777091|NCT04637503|Biological|GD2, PSMA and CD276 CAR-T cells|infusion, for 1x10^6~1x10^7 cells/kg via IV
15777092|NCT04637490|Device|patellar component|patellar resurfacing
15777093|NCT04637477|Behavioral|Virtual ELM|Participants will attend 1.5-hour virtual group-based sessions for 12 weeks. The program includes physical activity, cooking demonstrations, and group discussions. All sessions are led by a registered dietitian and health psychologist.
15777094|NCT04637464|Other|Early termination of empirical antibiotics|Termination of empirical antibiotics for febrile neutropenia based on clinical parameters, regardless of neutrophile count.
15777098|NCT04637425|Drug|Ismigen|Sublingual tablets containing 7 mg of bacterial lysate from the following bacteria: Staphylococcus aureus, Haemophilus influenzae serotype B, Klebsiella pneumoniae, Klebsiella ozaenae, Neiserria catarrhalis, Streptococcus viridans, Streptococcus pyogenes, Streptococcus pneumoniae (6 strains: TY1/EQ11, TY2/EQ22, TY3/EQ14, TY5/EQ15, TY8/EQ23, TY47/EQ24) - sublingual use 1 tablet per day over 10 days for 3 successive months.
15777099|NCT04637425|Drug|Placebo|Matched tablets without any active substance.
15777100|NCT04637412|Other|Menu label|Participants will be shown a sample of items from a restaurant menu, displayed with labels
15777101|NCT04637373|Diagnostic Test|Hysteroscopy|adding Hysteroscopy before and after suction curettage for early missed abortion to define the wall of implantation and look for retained products of conception
15777102|NCT04637360|Drug|Cinacalcet Tablets|All study subjects were treated with a fixed dose of oral Cinacalcet (25 mg/day) from baseline to 6 months.
15777103|NCT04637360|Drug|calcitriol|All hyperparathyroidism were treated as traditional therapy with oral calcitriol 0.25 mcg(dosage according to IPTH serum level) from baseline to 6 months.
15777104|NCT04637347|Device|Catheterization approach|In plane infraclavicular subclavian vein VS in plane supraclavicular subclavian vein catetherization
15777105|NCT04637334|Procedure|Superior vena cava reconstruction|Endovascular therapy with percutaneous transluminal angioplasty (PTA) and, in recent years, with stenting of the SVC, has been performed with increasing frequency. An endovascular approach is the current standard of care to relieve SVC obstruction due to malignancy to obtain prompt relief of the rapidly emerging symptoms and improve quality of life,3 keeping in mind the short life expectancy of these patients. The role of endovascular therapy in SVC syndrome of nonmalignant etiology is undecided because long-term durability of this treatment method remains to be assessed.
15777106|NCT04637321|Procedure|Solid organ transplant|Data will be collected on all liver, kidney, pancreas and combined transplant recipients who received their graft(s) from April 1, 2015 to July 31, 2018
15777107|NCT04637308|Drug|Succinylated gelatin|"Succinylated gelatin (SG, Gelofusine; B. Braun, Crissier, Switzerland) is a clear, inexpensive, safe, colloidal plasma volume-expanding solution, weight-average molecular weight (MWw) 30 kDa."
15777108|NCT04637282|Drug|PLX-200|15 mg/mL oral solution of experimental drug
15777109|NCT04637282|Drug|Placebo|Taste and color-matched drug-free solution
15777110|NCT04637269|Biological|anti-BCMA CAR-T|5×10^7 /KG 15×10^7 /KG 45×10^7/KG Treatment follows a lymphodepletion, chemotherapy regimen that consists of Fludarabine (30 mg/m2 per day) and Cyclophosphamide (300mg/m2 per day) for 3 days prior to cell infusion.
15777111|NCT04637243|Other|Treatment of Benign or Malignant Liver and Bile Duct Diseases|Available treatment of Benign or Malignant Liver and Bile Duct Diseases
15777112|NCT04637230|Diagnostic Test|Electrocardiogram analysis by Artificial Intelligence|1-channel electrocardiograms are collected to train an Artificial Intelligence in the automatic diagnosis of regular and irregular heart rhythms
15777113|NCT04637217|Diagnostic Test|Optical Coherence Tomography|Spectral Domain Optical Coherence Tomography(SD-OCT) examination will be performed for every patient: posterior pole scan, EDI-OCT(enhanced depth imaging-OCT) and peripapillary RNFL(retinal nerve fiber layer)
15777114|NCT04637204|Drug|Cabozantinib|oral therapy
15777115|NCT04637204|Drug|Axitinib|oral therapy
15777116|NCT04637191|Device|MentalPlus®|A digital game named MentalPlus will be used to evaluate the possibility of this game becoming a neuropsychological test.
15777117|NCT04637178|Behavioral|Resistance training|Resistance training sessions twice a week for ten weeks
15777118|NCT04637178|Behavioral|Endurance training (habitual)|Endurance training for ten weeks (habitual routines)
15777119|NCT04637165|Other|This is a non-interventional study|This is a non-interventional study
15777120|NCT04637152|Drug|Sacubitril-Valsartan|Use of sacubitril/valsartan after suspension of ACE inhibitors or ARBs.
15777121|NCT04637139|Drug|Vebicorvir (VBR)|300mg Vebicovir containing 2 µCi [14C]VBR.
15777122|NCT04637126|Other|Cardiac output measurement by transpulmonary thermodilution and transthoracic echocardiography|Cardiac output is measured for all patients with transpulmonary thermodilution TPTD and transthoracic echocardiography TTE according to the recommendations
15777123|NCT04637113|Other|This is a non-interventional study|This is a non-interventional study.
15777124|NCT04637100|Other|Mobile or tablet-based gaming applications|Subject will use their own personal smartphone or tablet device to play from a collection of pre-selected gaming applications. The collection is made of puzzle-type games available on both Android and iOS without excessive ads and with clear or self-explanatory instructions. Subject will be instructed to play for 1 hour daily for the duration of their acute inpatient rehabilitation stay (approximately 3 weeks).
15777125|NCT04637100|Other|Stroke-related educational videos|Subject will use their own personal smartphone or tablet device to watch videos from a collection of pre-selected educational videos. These include topics on stroke recognition, stroke recovery process, patient experiences with stroke, rehabilitation after stroke, activities of daily living equipment instructions. Subject will be instructed to watch for 1 hour daily for the duration of their acute inpatient rehabilitation stay (approximately 3 weeks).
15777126|NCT04637087|Other|Atrial fibrillation risk electronic health record alert|Electronic health record best practice alert which displays patient's 5-year risk of developing atrial fibrillation
15777127|NCT04637061|Combination Product|intraoperative near infrared (NIR) indocyanine green (ICG)-induced fluorescence angiography (FA) and air leak testing to assess the integrity and the perfusion levels of the colorectal anastomosis|Extra-luminal (serosa) and Endo-luminal (mucosal) evaluation of the proximal colon and distal rectal stump perfusion based on a semi-quantitative NIR-ICG-induced FA. This will be conducted administering IV a bolus of 3.75 to 7.5 mg of ICG and evaluated using a Fluorescence Imaging System; following after completion of the anastomosis a second bolos of 3.75 to 7.5 mg of ICG will be administered IV and the anastomosis will be visualized by insertion of the system trans-anally. Colon and rectal segments and quadrants will be scored for any defect of perfusion.
15777128|NCT04637061|Diagnostic Test|Air Leak test|This will be conducted insufflaying air in the anastomosis through a proctoscope, tube or a flexible endoscope, after filling of the pelvis with saline solution and luminal occlusion of the intestine proximal to the anastomosis. Also, the anastomosis will be checked transanally for the presence of air leak.
15777131|NCT04637009|Drug|TAS1553|Form: tablet; Route of Administration: oral
15777132|NCT04636996|Other|artificial intelligence assisted follow-up|We will use a new portable artificial intelligence assisted device to monitor the patients' postoperative heart rate and sleep quality, guiding the following follow-up process
15777133|NCT04636983|Drug|BV100|Rifabutin IV
15777134|NCT04636983|Drug|Placebo|Saline
15777135|NCT04636970|Other|Home training program|Subjects randomized to the IG will participate at home training program that will last 12 weeks and consists of endurance, flexibility, balance and cardiovascular resistance training performed with low to moderate intensity, in 20-60 minutes sessions, five times a week. Study participants will be asked to wear wrist and chest unobtrusive devices during active day time or at least during the training session and two hours before and after.
15777136|NCT04636957|Drug|Ciprofloxacin-Fluocinolone Acetonide, 0.3%-0.025% Otic Solution|0.25mL/vial, each vial contains 0.75mg of ciprofloxacin and 0.0625mg of fluocinolone acetonide.
15777137|NCT04636957|Drug|Ciprofloxacin 0.3% solution|0.4mL/vial, each vial contains 1.2mg ciprofloxacin
15777138|NCT04636944|Other|web-based COMPASS intervention|COMPASS is a web-based intervention (online CBT program) that was developed for managing illness-related anxiety and depression in patients with long-term conditions (LTC) (https://compass-ltc.org/). COMPASS is tailored to gain an understanding of the difficulties that LTC patients experience and provide information and tools on how to manage these. This qualitative study will explore participants' perspectives on using COMPASS for managing depression and anxiety in heart failure.
15777139|NCT04636918|Drug|Cyclosporine Ophthalmic|Prospective interventional study (single arm)
15777140|NCT04636905|Other|Questionnaires|Participants will be asked to complete a series of questionnaires assessing quality of life and other general health outcomes
15777141|NCT04636892|Other|MindMics earbud|Novel noninvasive wearable infrasound sensor
15777145|NCT04636866|Other|NO intervention|NO intervention
15777146|NCT04636853|Biological|Subretinal injection of umbilical cord blood platelet-rich plasma (CB-PRP)|"A subretinal injection of umbilical cord blood platelet-rich plasma (CB-PRP) will be performed only in one eye, the other eye will be considered as a control group.
~A complete morpho-functional ophthalmological evaluation will be performed in all patient at each control."
15777147|NCT04636840|Device|Space From Body and Eating Concerns- Teen|Self-guided mobile application to support eating disorder recovery efforts
15777148|NCT04636827|Biological|sIPV+DTaP+HepA|sIPV+DTaP+HepA at the age of 18 month old
15777149|NCT04636827|Biological|sIPV|sIPV at the age of 18 month old
15777150|NCT04636827|Biological|DTaP|DTaP at the age of 18 month old
15777151|NCT04636827|Biological|HepA|HepA at the age of 18 month old
15777152|NCT04636814|Drug|CHF6001 1600µg|CHF6001 400µg, 2 inhalations bid (total daily dose of 1600µg) and Roflumilast matching placebo, 1 tablet once daily
15777153|NCT04636814|Drug|CHF6001 3200µg|CHF6001 800µg, 2 inhalations bid (total daily dose of 3200µg) and Roflumilast matching placebo, 1 tablet once daily
15777154|NCT04636814|Drug|Placebo|CHF6001 matching placebo, 2 inhalations bid and Roflumilast matching placebo, 1 tablet once daily
15777155|NCT04636814|Drug|Roflumilast|- 1 tablet of Roflumilast (Daliresp®), 250µg, once daily during the first 4 weeks of treatment then 1 tablet of Roflumilast (Daliresp®), 500µg, once daily for the remaining treatment period and CHF6001 matching placebo, 2 inhalations bid
15777156|NCT04636801|Drug|Experimental: CHF6001 1600µg|CHF6001 400µg, 2 inhalations bid (total daily dose of 1600µg).
15777157|NCT04636801|Drug|Experimental: CHF6001 3200µg|CHF6001 800µg, 2 inhalations bid (total daily dose of 3200µg).
15777158|NCT04636801|Drug|Placebo|CHF6001 matching placebo, 2 inhalations bid.
15777159|NCT04636788|Procedure|Venous sampling|venous sampling of 12ml
15777160|NCT04636775|Diagnostic Test|Microbiome|Nasal and buccal swabs, and stool sample, as well as the extracted DNAs
15777161|NCT04636762|Procedure|Radiation Therapy|Thoracic Radiation Dose: 3Gy, QD, total dose: 30-40Gy; Suitable Metastatic lesions: SBRT, Radiation Dose: 30-50GY/5-10F.Particpants with brain metastases：metastatic lesions≤3:whole brain radiotherapy with local simultaneous PGTV:50Gy/10F；metastatic lesions>3:whole brain radiotherapy PTV:30Gy/10F.
15777162|NCT04636749|Device|Erbium laser|Vaginal laser therapy
15777163|NCT04636749|Device|Sham laser|Sham laser therapy
15777164|NCT04636736|Diagnostic Test|HIV drug resistance testing|HIV drug resistance testing in people newly diagnosed in HIV in Poland
15777165|NCT04636710|Procedure|Lymphoscintigraphy|An imaging procedure using an injected radioactive substance or dye to identify lymph drainage A doctor reviews the images to identify the sentinel lymph nodes based on where the dye goes to first.
15777166|NCT04636697|Drug|Intramuscular injection|Subjects will receive two doses of placebo given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once)
15777167|NCT04636697|Biological|Intramuscular vaccine|Subjects will receive two doses of 3.75 µg of CoVLP adjuvanted with AS03 adjuvant given 21 days apart into the deltoid region of the alternating arm (each arm will be injected once)
15777168|NCT04636684|Diagnostic Test|Proteomic analysis|Proteomic analysis based on mass spectrometry on the sample of valve tissues.
15777169|NCT04636671|Drug|Methylprednisolone|Per-protocol methylprednisolone administration and tapering (see arm description)
15777170|NCT04636671|Drug|Dexamethasone|Per-protocol dexamethasone administration (see arm description)
15777171|NCT04636658|Other|Incentive spirometer training|Incentive spirometer training 5 sessions a week, each session of 15 minutes, for 4 weeks
15777196|NCT04636450|Procedure|Rotatory technique pulpectomy|Primary mandibular molars treated with a rotatory technique pulpectomy and a K3 system or a Kedo-S system.
15777172|NCT04636658|Other|diaphragmatic resistance exercises|"Incentive spirometer with diaphragmatic resistance exercises. Resistance is applied through the different Thera bands and then performing the pursed lip breathing exercise. Resistance increased weekly as per tolerance by the patient.
~Digital spirometer training for 15 minutes. diaphragm breathing exercises with resistance for 30 minutes. 5 sessions a week, for 4 weeks"
15777173|NCT04636645|Other|Normal treadmill|Participants will exercise for 25 minutes under low-load walking conditions three times a week for 8 consecutive weeks on the AGT treadmill at a set speed of 3.1 mph at 0-degree incline. For each session, 20% support will be given to participants.
15777174|NCT04636645|Other|Anti-gravity treadmill with lower limb positive pressure|Participants will be exercised for 25 minutes under normal-load walking conditions three times a week for 8 consecutive weeks on the AGT treadmill at a set speed of 3.1 mph at 0-degree incline. Participants will be blinded to the study groups.
15777175|NCT04636645|Other|Anti-gravity treadmill with without lower limb positive pressure|Participants will be exercised for 25 minutes three times a week for 8 consecutive weeks on the normal treadmill at a set speed of 3.1 mph at a 0-degree incline. Participants will be blinded to the study groups.
15777176|NCT04636632|Drug|fosaprepitant|fosaprepitant 150mg/m2 weekly or triweekly during concurrent chemoradiotherapy
15777177|NCT04636619|Procedure|Colonic polypectomy|Cold snare resection of colorectal polyps
15777178|NCT04636619|Behavioral|Online training course|Polypectomy technique online course
15777179|NCT04636619|Behavioral|Incomplete resection report|Each participant will receive the global data, the results obtained by all the endoscopists (anonymously except for each interested party, the rest being identified by codes), as well as a detailed analysis of their results
15777180|NCT04636606|Procedure|Home Exercise|Educational training program about oral dysphagia in patients with temporomandibular disorders.
15777181|NCT04636606|Procedure|Manual Therapy Combined with Home Exercise|Manual therapy program combined with educational training program about oral dysphagia in patients with temporomandibular disorders.
15777182|NCT04636606|Procedure|Orofacial Myofunctional Therapy combined with Manual Therapy and Home Exercise|Orofacial Myofunctional Therapy program with combination of Manual therapy and educational training program about oral dysphagia in patients with temporomandibular disorders.
15777183|NCT04636593|Drug|Almonertinib|All enrolled patients underwent positioning CT scans before the initial treatment, a radiotherapy plan was made for each patient, and the lung V20 of each patient was calculated. Patients with lung V20 ≥ 28% were enrolled in group A: Almonertinib induction therapy was given for 2 months firstly, followed by Almonertinib combined with radiotherapy; patients with lung V20<28% were enrolled in group B: Almonertinib was synchronized with radiotherapy initially.
15777184|NCT04636580|Behavioral|parent accompanying the child during treatment|After the parents were divided into two groups, anxious and non-anxious, the groups were equally divided randomly and the parents accompanied their children during the treatment
15777185|NCT04636567|Drug|Nerindocianine for injection|Procedure: routine minimally invasive abdominopelvic surgery.
15777186|NCT04636554|Other|Phage Therapy|Personalized intravenous phage therapy in Covid-19 patients along with anti-microbial treatment for pneumonia, bacteremia or septicemia due to A. baumannii, P. aeruginosa or S. aureus.
15777187|NCT04636541|Behavioral|Goal Management Training|Goal Management Training® (GMT) has been developed to improve executive functions. It was validated in patients presenting executive dysfunction following many conditions: acquired traumatic brain injury, neurodevelopmental spina bifida, attention deficit and hyperactivity disorder (ADHD), subjective cognitive complaints and multiple sclerosis. GMT includes self-instruction strategies, self-monitoring exercises, cognitive training techniques, psychoeducation on cognitive processes, mindfulness exercises and assignments between sessions. It has been shown to increase patient awareness of deficits and improve cognitive control in goal-directed behaviors. The original GMT is a nine-week program administered to dysexecutive patients in 90-to-120-minute group sessions. Thus, it might be suitable for PD-MCI patients presenting with executive dysfunction.
15777188|NCT04636541|Behavioral|Psychoeducation|See the Arm section for full details. For a justification of how we designed this intervention: Many clinical guidelines include general recommendations about giving information to PD patients and family so they can take part into decision process. However, few standardized psychoeducation interventions are available, and they don't include information on PD cognitive decline. Some studies investigated Mindfulness Based Stress Reduction (MBSR) and other related mindfulness interventions in PD patients. In this approach, formal meditative exercises are included to develop non-judgmental attention to experiences in the present moment. In elderly patients with MCI unrelated to PD, mindfulness interventions show positive effects on cognitive functioning, including attention, executive functioning and memory (Gard et al., 2014). Therefore, non-pharmacological interventions for PD-MCI including both education on cognitive symptoms, as well as mindfulness exercises, are promising.
15777189|NCT04636528|Device|Digital rehabilitation|"Patients in the digital intervention group will benefit from an 8-week program composed of therapeutic exercise, education and cognitive behavioural therapy (CBT) program provided by SWORD Health.
~Patients in this group will performed home-based rehabilitation sessions using SWORD Phoenix®, under remote monitoring by a physical therapist."
15777190|NCT04636528|Device|Conventional rehabilitation|"Patients in this group will benefit from a 8-week program consisting of two 30 min face-to-face PT sessions per week in an outpatient clinic setting, for a total of 16 sessions. The program includes commonly used interventions adapted by the physical therapist to the specific needs of the participant.
~In addition to the face-to-face sessions, PTs will also be communicating with participants in this group through a secure messaging system (Mychart) used at UCSF or, alternatively, through a telephone check-ins (10-15 min calls, up to twice per week)."
15777191|NCT04636515|Drug|F520|200mg，Q3W
15777192|NCT04636489|Dietary Supplement|Highland barley β-glucan dietary supplement|100 mL oral liquid mainly containing highland barley β-glucan once daily for 8 weeks
15777193|NCT04636489|Other|Placebo controls|Placebo with a similar appearance and taste to highland barley β-glucan supplement
15777194|NCT04636476|Procedure|Modified Nesbit's procedure and dorsal dartos flap|Modified Nesbit's procedure to correct the penile curvature and dorsal dartos flap to correct the associated penile torsion
15777195|NCT04636463|Procedure|Intraoperative Music|Hand Surgery performed with the participant awake, using local anesthesia. Headphones will be worn by the participant and surgery will be performed while the participant is listening to music
15777197|NCT04636450|Procedure|Manual pulpectomy|Primary mandibular molars treated with a manual pulpectomy and a K-file system or a Kedo-SH system.
15777198|NCT04636437|Drug|Doravirine 100 Mg|Participants will receive 100 mg tablet by mouth daily with or without food.
15777199|NCT04636437|Drug|Tenofovir alafenamide/emtricitabine|NRTIs for all arms (TAF/FTC, TAF/3TC, TDF/FTC, or TDF/3TC) and INSTIs for Arm 3 will be acquired through standard of care locally.
15777200|NCT04636437|Drug|tenofovir alafenamide/lamivudine|NRTIs for all arms (TAF/FTC, TAF/3TC, TDF/FTC, or TDF/3TC) and INSTIs for Arm 3 will be acquired through standard of care locally.
15777201|NCT04636437|Drug|Integrase strand transfer inhibitors|NRTIs for all arms (TAF/FTC, TAF/3TC, TDF/FTC, or TDF/3TC) and INSTIs for Arm 3 will be acquired through standard of care locally.
15777202|NCT04636437|Drug|tenofovir disproxil fumarate/emtricitabine|NRTIs for all arms (TAF/FTC, TAF/3TC, TDF/FTC, or TDF/3TC) and INSTIs for Arm 3 will be acquired through standard of care locally.
15777203|NCT04636437|Drug|tenofovir disproxil fumarate/lamivudine|NRTIs for all arms (TAF/FTC, TAF/3TC, TDF/FTC, or TDF/3TC) and INSTIs for Arm 3 will be acquired through standard of care locally.
15777204|NCT04636424|Other|assesment of gait|speed and weight distribution during gait
15777205|NCT04636411|Dietary Supplement|Oral Magnesium Supplementation|250 mg of elemental magnesium daily for three months
15777206|NCT04636411|Other|Standard Care for diabetic patients|Health education, oral antihyperglycemic medications according to American Diabetes Association (ADA) guidelines
15777207|NCT04636398|Behavioral|MESSAGE - mHealth intervention|A group-based moderated six-week intervention with didactic, discussion, and text communication components.
15777208|NCT04636385|Other|Observational study no intervention|No intervention
15777209|NCT04636372|Device|Intense pulsed light therapy|Patients with xerophthalmia were treated with intense pulsed light of meibomian gland.
15777210|NCT04636372|Other|Hot compress massage|Patients with xerophthalmia were treated with hot compress massage of meibomian gland.
15777211|NCT04636359|Behavioral|Acupuncture stimulation|The intervention is about acupuncture treatment, which has 4 weeks acupoint stimulation and the frequency is 30 minutes each times for 3 times per week. The acupoints include SJ23 (Si Zhu Kong, unilateral), GB8 (Shuai Gu, unilateral), EX-HN5 (Tai Yang, unilateral), GB20 (Feng Chi, unilateral), LI4 (He Gu, bilateral), GB41 (Zu Lin Qi, bilateral), GB34 (Yang Ling Quan, bilateral) and SJ5 (Wai Guan, bilateral).
15777212|NCT04636346|Behavioral|Acceptance and Commitment Therapy|Seven group sessions
15777213|NCT04636346|Other|Questionnaires|Outcomes measured include anxiety, depression, fear of recurrence, psychological flexibility, mindfulness; values based living, and quality of life. Participants completed surveys at 4 time points, pre and post, and two follow-up time points.
15777214|NCT04636333|Biological|Two doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14|Two doses of middle-dose (20µg/0.5ml) recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14.
15777215|NCT04636333|Biological|Three doses of middle-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28|Three doses of middle-dose (20µg/0.5ml) recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28.
15777216|NCT04636333|Biological|Two doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14|Two doses of high-dose (40µg/0.5ml) recombinant SARS-CoV-2 vaccine (CHOCell) at the schedule of day 0, 14.
15777217|NCT04636333|Biological|Three doses of high-dose recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28|Three doses of middle-dose (40µg/0.5ml) recombinant SARS-CoV-2 vaccine (CHO Cell) at the schedule of day 0, 14, 28.
15777218|NCT04636333|Biological|Two doses of placebo at the schedule of day 0, 14 #middle-dose group#|Two doses of placebo (0.5ml) at the schedule of day 0, 14.
15777219|NCT04636333|Biological|Three doses of placebo at the schedule of day 0, 14, 28 #middle-dose group#|Three doses of placebo (0.5ml) at the schedule of day 0, 14, 28.
15777220|NCT04636333|Biological|Two doses of placebo at the schedule of day 0, 14 #High-dose group#|Two doses of placebo (0.5ml) at the schedule of day 0, 14.
15777221|NCT04636333|Biological|Three doses of placebo at the schedule of day 0, 14, 28 #High-dose group#|Three doses of placebo (0.5ml) at the schedule of day 0, 14, 28.
15777222|NCT04636320|Device|Contrast-enhanced CMR|Cardiac Magnetic Resonance Imaging (MRI) examinations will be performed at Day 0 visit on clinical systems 1.5 equipped with specific antennas for cardiac imaging. The imaging protocol will last approximately 50 minutes.
15777223|NCT04636320|Diagnostic Test|Exercise test ECG|"A treadmill exercise test with 12 lead ECG monitoring will be performed at M3 visit.
~Maximum expected enrollment 30 MRI+ patients and 30 healthy volunteers MRI- matched controls."
15777224|NCT04636320|Biological|Blood sample|"A blood sample will be taken at Day 0 visit for COVID-19 serology, hematocrit measurement, ultra-high sensitive troponin test, low grade markers of inflammation, genetic profiling.
~An other blood sample will be taken at M3 visit for a control COVID-19 serology for 30 healthy volunteers."
15777225|NCT04636320|Diagnostic Test|Resting 12 lead ECG|A resting 12 lead ECG will be performed at Day 0 visit.
15777226|NCT04636320|Diagnostic Test|24 hour Holter ECG|A 24 hour Holter ECG will be performed at M3 visit. Maximum expected enrollment 30 MRI+ patients and 30 healthy volunteers MRI- matched controls.
15777227|NCT04636307|Other|Biomarkers|To identify biomarkers obtained using non-invasive procedures that can predict disease progression and progression to sight-threatening stages of the disease and to characterize the retinal changes that occur in NPDR.
15777228|NCT04636294|Diagnostic Test|SARS-CoV-2 PCR|SARS-CoV-2 PCR of nasopharyngeal lysate.
15777230|NCT04636268|Biological|FIB Grifols|"FIB Grifols is the IP and will be administered via slow intravenous (IV) infusion at a rate not to exceed 5 mL/minute.
~Dosing will be individually calculated for each subject based on the target plasma fibrinogen level according to the type of bleeding, measured actual plasma fibrinogen level before infusion, and body weight. The IP will be administered according to the nominal potency of the product."
15777231|NCT04636255|Procedure|Physical Characteristics|Body Weight, Height
15777232|NCT04636255|Diagnostic Test|Assessment of Heart rate variability|Holter 24h
15777403|NCT04634825|Biological|Enoblituzumab|Anti-B7-H3 antibody
15777404|NCT04634825|Biological|Retifanlimab|Anti-PD-1 antibody
15777233|NCT04636255|Diagnostic Test|Blood Pressure and Cardiac Autonomic Control|Non-invasive photoplethysmography (Finometer® PRO) monitored by the electrocardiogram and respiratory frequency by a piezoelectric chest strap.
15777234|NCT04636255|Diagnostic Test|Evaluation of Baroreflex Control|The magnitude and latency of the baroreflex control of the heart rate will be assessed by bivariate analysis using the autoregressive method.
15777235|NCT04636255|Diagnostic Test|Cardiac Function and Structure|Echocardiogram
15777236|NCT04636255|Diagnostic Test|Assessment of Coronary Anatomy and Calcium Score|Angiotomography
15777237|NCT04636255|Diagnostic Test|Blood Assessments|Serum and Plasma will be extracted by centrifugation. NT-pro BNP (Roche™) and c-TnI (imunoassay Elecys 2010).
15777238|NCT04636255|Diagnostic Test|Physical Capacity|Cardiopulmonary Exercise Test.
15777239|NCT04636255|Procedure|Physical Training|Aerobic exercise: 48 sessions of 60 minutes: 5 minutes of warm-up, 40 minutes of exercise. Resistance exercise: 10 minutes of exercise and 5 minutes of recovery.
15777240|NCT04636242|Procedure|Skin Biopsy|A Biopsy of the skin where the arthroscopic instrument will be placed, will be taken and sent to the microbiology lab for analysis
15777241|NCT04636242|Drug|5 Aminolevulinic Acid + Phototherapy|5 aminolevulinic acid solution will be placed on the skin of the shoulder and the participant will receive Photodynamic therapy on the morning of surgery
15777242|NCT04636229|Biological|Amniotic Suspension Allograft|This investigational product is a cryopreserved product derived from human amnion and cells from the amniotic fluid.
15777243|NCT04636229|Drug|Placebo|Matching placebo is 0.9% normal saline: 4 mL to be injected IA.
15777245|NCT04636190|Device|Triathlon All-Polyethylene Tibia Knee|Triathlon All-Polyethylene Tibia Knee is an all polyethylene resurfacing knee device using either a condylar stabilizing (CS) and posterior stabilizing (PS) device.
15777246|NCT04636177|Behavioral|Pain Rehabilitation Virtual Reality (PRVR)|Participants allocated to either intervention arm will receive 8, 1-hour physiotherapy sessions delivered over the course of 6-8 weeks. Adequate dose: 75% (6 of 8 sessions).
15777247|NCT04636177|Behavioral|Standard Physiotherapy Rehabilitation (SPR)|Participants allocated to either intervention arm will receive 8, 1-hour physiotherapy sessions delivered over the course of 6-8 weeks. Adequate dose: 75% (6 of 8 sessions).
15777248|NCT04636164|Diagnostic Test|Model Dermatology (deep neural networks; Build 2020)|Physicians in the DNN group take pictures of the skin lesion and use the algorithm by uploading pictures.
15777249|NCT04636151|Behavioral|Ecological momentary intervention|Content of this intervention is based on pre-established transdiagnostic protocols for addressing the negative emotion associated with suicidal thoughts and behaviors.
15777250|NCT04636138|Other|Exercise|Patients will exercise on a treadmill three times weekly at approximately 60% VO2max for 30 minutes (week one) followed by 45 minutes (week two and thereafter) for a total of 6 seeks.
15777251|NCT04636125|Drug|Doxycycline 100 MG Oral Tablet|Patients that are undergoing a single stage revision total shoulder arthroplasty will be enrolled in this study. As is standard of care, routine cultures will be taken from predetermined areas in the shoulder. All patients will be treated with 13 days of oral Doxycycline pending culture results.
15777252|NCT04636099|Device|CT angiography（CTA）|The CTA group was peformed upper abdomen enhenced and CT Angiography before surgery
15777253|NCT04636086|Drug|Cholecalciferol|Vitamin D supplementation
15777254|NCT04636086|Other|Placebo|Placebo comparator
15777255|NCT04636073|Device|Leaflex™ Performer|A transfemoral catheter designed to treat calcific aortic stenosis by scoring the calcification in the aortic valve leaflets.
15777256|NCT04636060|Dietary Supplement|Eisen|Treatment with low-dose iron in the form of tablets containing 6mg of iron. Treatment consists of twice-daily oral administration of iron-tablets for 8 weeks in total.
15777257|NCT04636047|Other|The method of gene mutation detection|All samples were detected by NGS CGP panel.
15777258|NCT04636034|Procedure|Sphenopalatine Ganglion Block with Local Anesthetic|Block performed with bilaterally inserted q-tips with 1:1 mixture of lidocaine 40mg/ml and ropivacaine 5mg/mL
15777259|NCT04636034|Procedure|Sphenopalatine Ganglion Block with Placebo (Isotone NaCl)|Block performed with bilaterally inserted q-tips with isotone NaCl
15777260|NCT04636034|Procedure|"Sham-block with Placebo (Isotone NaCl)"|Block performed with bilaterally inserted q-tips with isotone NaCl. The q-tips are inserted a maximum of 3 cm into the nasopharynx thus not reaching the mucus above the ganglion.
15777261|NCT04636021|Diagnostic Test|COVID-19 testing|Pre and post procedure COVID-19 testing for patients undergoing outpatient cardiac procedures.
15777262|NCT04636008|Drug|Sintilimab|Sintilimab+Hypofractionated radiotherapy
15777263|NCT04636008|Radiation|Hypofractionated Radiotherapy|Hypofractionated Radiotherapy
15777264|NCT04635995|Biological|LVGN7409|IV infusion once every 3 weeks (Q3W).
15777265|NCT04635982|Other|Kinesiotape of the physical performance|It has done a countermovement vertical jump, a twenty meter sprint and a kinesio tape application technique
15777266|NCT04635969|Behavioral|Sexual Health and Development Education for Children With Intellectual Disability|Sexual Health and Development Education for Children With Intellectual Disability: It is aimed to eliminate the problems related to personal care and cleaning of children with mental retardation, to learn the symptoms of adolescence and to learn the methods of protection from abuse.
15777267|NCT04635956|Drug|Drug therapy|6 courses of platinum/etoposide/bevacizumab/camrelizumab and a total period of 12 months bevacizumab/camrelizumab
15777268|NCT04635943|Drug|Ivermectin|One daily dose of NOXAL-Ivermectin Oral Solution (6 mg/mL) at 300mcg/kg for three (3) consecutive days. A weight-equivalence table will be used to determine each participant´s dose (number of oral drops/day).
15777269|NCT04635943|Drug|Placebo|The placebo presentation will be an oral drop solution undistinguishable from ivermectin, but without this device pharmaceutical ingredient.
15777270|NCT04635930|Other|Taping plus Traditional exercises|The children will be taped 6 days per week for a total a period of 08 weeks. The tape will be used and keep the scapula in position for 3 days and the region will then be left to rest for 24 hours. Kinesio Taping will then be re-applied by the same experienced research assistants for another 3 days.
15777405|NCT04634825|Biological|Tebotelimab|PD-1 X LAG-3 bispecific DART molecule
15777406|NCT04634812|Drug|KBP-5074|a single oral dose of [14C]-KBP-5074
15777271|NCT04635917|Other|Personalized diet|Participants in this group will receive tailored nutrition counseling from a dietitian. To facilitate meeting these dietary goals, participants will be provided with nuts, fruits, and vegetables.
15777272|NCT04635917|Other|Conventional dietary advice|Participants in the CD group will receive non-personalized, conventional dietary advice by a dietitian based on the MyPlate guidelines.
15777273|NCT04635904|Behavioral|Imaginal exposure one-session|Participants in this arm will be asked to decide alongside with the intervention provider (a clinical PhD student or M.A student under the supervision of the principal investigator) to imagine a script based on a future distressing anxiety provoking scenarios multiple times while honing in on the most negative aspects.
15777274|NCT04635904|Behavioral|Imagery rescriptinf one-session|Participants in this arm will be asked to decide alongside with the intervention provider (a clinical PhD student or M.A student under the supervision of the principal investigator) o imagine a script based on a future distressing anxiety provoking scenarios one time while honing in on the most negative aspects. Afterwards they will insert changes into the script that try to help them cope in the imagery.
15777275|NCT04635878|Other|Blood collection|Blood collection (at admission, two days, one week and at discharge) to analyze the activation of NLRP3 inflammasome in platelets and leukocytes
15777276|NCT04635865|Device|3D-printed patient-specific plate|"We adopt an in-house approach for designing by surgeons. All patient-specific devices are designed in 3-matic 13.0 (Materialise). Both cutting and transferring guides are then additively manufactured by Fused Deposition Manufacturing (FDM) using ULTEM 1010, or by Stereolithography using MED610 resin (Stratasys Ltd, Eden Prairie, MN, USA). Both ULTEM 1010 and MED610 are FDA cleared biocompatible materials applicable to high-temperature autoclaving.
~Patient-specific surgical plates are designed by delineating a plate path on bone surface, then followed by the placement of screw holes. Surgical plates are generated by the built-in command in 3-matic. After that, surgical plates are fabricated by SLM using grade 2 titanium powder."
15777277|NCT04635865|Device|Conventional commercial reconstruction plate|Bone segments will be stabilized using commercial titanium surgical plates (DePuy Synthes, United States), which are bent manually before fastening the screws.[
15777278|NCT04635852|Drug|Fentanyl|
15777279|NCT04635852|Drug|Immediate release morphine|
15777280|NCT04635839|Drug|Standard Dose of Unfractionated Heparin|5,000 units subcutaneous unfractionated heparin every 12 hours
15777281|NCT04635839|Drug|Gestational Age-Based Dose of Unfractionated Heparin|"First trimester (< 14 weeks of gestation): 5,000 units subcutaneous unfractionated heparin every 12 hours
~Second trimester (14-28 weeks of gestation): 7,500 units subcutaneous unfractionated heparin every 12 hours
~Third trimester (> 28 weeks of gestation): 10,000 units subcutaneous unfractionated heparin every 12 hours"
15777282|NCT04635826|Drug|Adderall 10Mg Tablet|Participants will be administered Adderall
15777283|NCT04635826|Drug|Placebo|Participants will be administered placebo
15777284|NCT04635813|Procedure|Thyroidectomy|Thyroidectomy
15777285|NCT04635800|Drug|MHU650|MHU650 powder for solution for injection
15777286|NCT04635787|Device|ANNE One|Wireless vital sign monitoring device
15777287|NCT04635774|Drug|Insulin|40 IU via four activations of an intranasal spray
15777288|NCT04635774|Drug|Saline|Four activations of an intranasal spray containing placebo (normal saline).
15777289|NCT04635761|Behavioral|Educational Intervention|Complete AIR Program and receive the High-Risk Lung Cancer Tip Sheet
15777290|NCT04635761|Behavioral|Questionnaire Administration|Ancillary studies
15777291|NCT04635735|Drug|Ipilimumab|Ipilimumab 3 mg/kg every 3 weeks for 4 doses.
15777292|NCT04635722|Behavioral|Weight Management Intervention|Participants attend group and individual dietary education sessions. Participants create a diet plan that satisfies their needs. Participants aim to lose 1 pound weekly until a BMI of 25 is reached. Participants are evaluated through daily self-weighing, dietary records, and food frequency questionnaires.
15777293|NCT04635709|Device|biofeedback training and interferential therapy|compare the effect of applying both types of devices on the pelvic floor muscles
15777294|NCT04635696|Drug|Ethyl chloride|Pressurized vapocoolant developed for acute, mild pain relief.
15777295|NCT04635696|Other|Tissue culture grade water|Pressurized water mist
15777296|NCT04635683|Drug|Lenalidomide|Given PO
15777297|NCT04635683|Biological|Ublituximab|Given IV
15777298|NCT04635683|Drug|Umbralisib|Given PO
15777299|NCT04635670|Dietary Supplement|Pro-/prebiotic Mix|Soluble powder for oral use of pre-/probiotic mix 3.0 g twice daily.
15777300|NCT04635670|Dietary Supplement|Placebo|Soluble powder for oral use twice daily.
15777301|NCT04635657|Other|Long-term Cognitive testing|These patients will undergo their standard of care cognitive testing at baseline, six weeks post-operatively and one year post-operatively.
15777302|NCT04635644|Procedure|Erector Spinae Plane Block|Patients will be turned into the prone position. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T8 spinous process. The erector spinae muscles will be identified superficial to the tip of the T8 transverse process. After local infiltration of the needle insertion site with 2-3 ml of 2% lidocaine, a 21G 10 cm needle will be inserted using an in-plane approach in a cranial to caudal direction to contact the T8 transverse process. The location of the needle tip will be confirmed by hydrodissection with 2 mL of lidocaine 2% and visualizing linear fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. A volume of 20 mL of 0.25% Bupivacaine is injected will be injected at this point. The same procedure will be repeated for the opposite side.
15777303|NCT04635644|Procedure|Intrathecal morphine|Patients will be placed on their right side. An intrathecal injection of morphine 200 μg (0.2 mL of morphine sulfate 1 mg/mL) diluted in 1.8 mL normal saline will be administered at the L3-L4 or L4-L5 level with a 25 G Whitacre spinal needle.
15777304|NCT04635631|Drug|talazoparib|Talazoparib will be administered orally on a continuous basis. Each cycle will consist of 28 days.
15777305|NCT04635618|Behavioral|Cognitive Behavioral Brief-Telepsychotherapy|Four sections of Cognitive Behavioral Brief-Telepsychotherapy plus personalized pre-recorded videos
15777306|NCT04635618|Behavioral|Brief Interpersonal Telepsychotherapy|Four sections of Brief Interpersonal Telepsychotherapy plus personalized pre-recorded videos
15777307|NCT04635618|Behavioral|Telepsychoeducation|A single session psychoeducation group plus weekly personalized pre-recorded videos for 4 weeks
15777308|NCT04635605|Drug|Methylene Blue|Treatment Group. Methylene Blue 100 mg capsules, twice a day for 5 consecutive days, will be added to the current therapy of the patient, if any.
15777309|NCT04635605|Drug|Control Test|Arm B: Control Group. Placebo capsules 100 mg twice a day for 5 consecutive days, will be added to the current therapy of the patient, if any.
15777310|NCT04635592|Diagnostic Test|SARS-CoV2 nasal swab|SARS-CoV2 nasal swab and venous blood for SARS-CoV2 antibodies
15777311|NCT04635579|Device|Blood flow restriction|Intervention restricts blood flow to the lower limb as a percentage of the limb occlusion pressure
15777312|NCT04635566|Drug|mebeverine 200 mg sustained-release (Coloverine® SR, Chemipharm pharmaceutical, Egypt) one time/day at the evening.|mebeverine 200 mg sustained-release (Coloverine® SR, Chemipharm pharmaceutical, Egypt) one time/day at the evening. 200 mg sustained-release (Coloverine® SR, Chemipharm pharmaceutical, Egypt) one time/day at the evening.
15777313|NCT04635566|Drug|Placebo|Placebo one time/day at the evening.
15777314|NCT04635553|Drug|Praziquantel 600 milligram|A single treatment with a dose of 40 milligram/kilogram (mg/kg)
15777315|NCT04635540|Behavioral|Educational Brochure|Educational brochure on decreased empathy and emotion recognition in patients with neurodegenerative disease
15777316|NCT04635527|Drug|IBI318|before surgery IBI318 intravenous injection Q2W,after surgery IBI318 intravenous injection Q4W
15777317|NCT04635527|Procedure|cTACE|conventional transarterial chemoembolization
15777318|NCT04635527|Drug|placebo|before surgery placebo intravenous injection Q2W,after surgery placebo intravenous injection Q4W
15777319|NCT04635514|Procedure|Lateral colporrhaphy|
15777320|NCT04635501|Device|ABS 5.6.7|Patients whose access site will be closed with the ABS 5.6.7
15777321|NCT04635488|Procedure|lateral lymph node dissection|All participted would receive lateral lymph node dissection for rectal cancer.
15777322|NCT04635475|Behavioral|RISE Bundle|Toolkit to build capacity where students receive education and provide symptom based and tailored accommodations after concussion
15777323|NCT04635462|Other|Physical exercise training|Participants will be encouraged to complete exercise training programs in the form of video capsules available via Facebook or Youtube, created by kinesiologists of the Montreal Heart Institut EPIC prevention center. The videos last about 15 minutes and include a warm-up of 3 to 5 minutes, followed a 10-minute training and finally a 2-minute cool-down period. The exercises on video do not require any equipment and integrate, depending on the video, aerobic, muscular strengthening, flexibility and/or balance exercises. Several intensities are described according to the participants' level. Participants will be invited to perform exercise sessions at least 5 times a week, and will be monitored weekly by phone by a member of the research team. The exercise sessions can be performed at home using the video training program, as well as in sports centre or outdoors. For each session, participants have to report its duration, intensity, and the nature of the activity via a follow-up agenda.
15777324|NCT04635462|Other|Cognitive training|Participants will be encouraged to perform sessions of cognitive training 3 times per week (30 minutes/session). Two of these sessions will involve computer or tablet-based attentional control training targeting dual-tasking, updating and working memory, as well as inhibition and switching. Difficulty of cognitive training will be tailored to participants' performances. The remaining session will consist of memory training. Participants will be instructed different mnemotechnic, as well as be taught about memory in aging in general. The memory training will be provided by videos capsules. To track adherence to cognitive training, participants will be asked to complete a journal and mark days and times where they took part in the various cognitive training sessions.
15777325|NCT04635449|Other|Age-specific information booklet and targeted telephone call|age-specific information, complemented by a follow-up targeted telephone call to reduce psychological sequelae in the child and their parents after PICU discharge.
15777326|NCT04635436|Other|Pathologic group|"Participants will walk on a split-belt treadmill mounted on force sensors with the belts running at the same or at different velocities. They will walk freely without hanging to any support. The test sequence will be the following:
~Baseline phase. 3 minutes walking at increasing speed from 0.2 m s-1 to 0.6 m s-1, speed will be increased of 0.1 m s-1 every 30 s. A brief pause of around 1 minute will follow.
~Habituation phase. 30 seconds walking at 0.2 m s-1.
~Adaptation phase. The velocity of the belt under the non-affected lower limb will be increased to 0.6 m s-1, while the other belt will maintain its velocity of 0.2 m s-1 for 6 minutes.
~Post-adaptation phase. Belts' velocities will be restored at 0.2 m s-1 for 6 minutes.
~Participants will be informed before the changes in belts' velocities with a verbal warning.
~Participants will repeat the same protocol with the affected lower limb on the fast belt after one week."
15777327|NCT04635423|Biological|V503|9-valent vaccine, HPV 6/11/16/18/31/33/45/52/58, L1 virus-like particle (VLP) 30/40/60/40/20/20/20/20/20 mcg per dose.
15777328|NCT04635423|Other|Placebo|0.9% sodium chloride (NaCL)
15777329|NCT04635410|Other|ULTRASOUND IMAGING|SCAN LABOURING WOMEN BY ULTRASOUND
15777330|NCT04635371|Device|Non-invasive Monitoring|Wearable, wireless, non-invasive chest-patch devices will be attached to the patients following recruitment and aigning an informed consent form, and from that moment on, vitals will be collected automatically and analyzed retrospectively.
15777331|NCT04635358|Behavioral|Hypnosis|Setting up hypnosis sessions
15777332|NCT04635358|Behavioral|Psychological support|Setting up psychological support
15777333|NCT04635358|Behavioral|Nutrional support|Setting up nutritional support
15777334|NCT04635345|Other|External Vibrator - patient-administered.|Patient provided with external vibrator for self-use, as well as vaginal dilators.
15777335|NCT04635345|Other|Standard care|Dilators, lidocaine topical gel, referral to psychotherapy, group therapy or womens health physio if required, self-help resources.
15777336|NCT04635332|Behavioral|Food literacy and physical activity promotion interactive group sessions + Developed health promotion intervention materials (booklet)|"Information, skills training, goal setting and feedback interactive group sessions to improve food literacy aimed at increasing consumption of fruits and vegetables
~Information, skills training, goal setting and feedback interactive group sessions to increase engagement in moderate physical activity
~Information and skills training to increase ability to evaluate nutrition information
~In general, focus will be on increasing knowledge, skills and self-efficacy to develop a lifelong healthy and gastronomic relationship with food and physical activity."
15777407|NCT04634799|Drug|TM5614|TM5614 is provided in 30 mg tablets and 6 tablets (180 mg) will be taken in the evening for up to 7 days.
15777337|NCT04635332|Behavioral|Developed health promotion intervention materials (booklet).|In the control arm, participants will only be given the developed intervention materials (designed in form of the usual awareness programs). No group sessions will be conducted
15777338|NCT04635306|Diagnostic Test|Approved GEBT test meal|FDA-approve GEBT test meal
15777339|NCT04635293|Procedure|preoperative infusion of levosimendan|the study group will consist of patients who have received a continuous infusion of levosimendan 0.1 μg/kg/min for 24 hours before cardiac surgery
15777340|NCT04635293|Procedure|no preoperative infusion of levosimendan|the control group will consist of patients who proceeded to the cardiac operation without any infusion for 24 hours preoperatively
15777341|NCT04635280|Device|any closed-loop automatic insulin delivery system (or artificial pancreas) CE-marking|A closed-loop automatic insulin delivery system includes a combination of an insulin pump, a continuous glucose monitoring system and a dedicated terminal.
15777342|NCT04635267|Other|Prone position in patients with ARDS|Transpulmonary thermodilution, arterial blood gas and recruitment/inflation calculation will be made every 8 hours: at baseline (just before prone position), after eight hours of prone position, after 16 hours of prone position (end of prone position), after 24 hours ( 8 hours after the end of prone position).
15777343|NCT04635254|Other|Halophites-based cream 24 hours|The concentration of active aqueous extract will be in the range of 2% to 30% (v/v) by cold emulsification. A 2 gram amount of Halophytes-based cream will be applied under occlusion (TegaDerm tape) in a 4x4 cm squared area.
15777344|NCT04635254|Other|Halophites-based cream 48 hours|The concentration of active aqueous extract will be in the range of 2% to 30% (v/v) by cold emulsification. A 2 gram amount of Halophytes-based cream will be applied under occlusion (TegaDerm tape) in a 4x4 cm squared area.
15777345|NCT04635254|Other|Vehicle cream 24 hours|A 2 gram amount of vehicle cream will be applied under occlusion (TegaDerm tape) in a 4x4 cm squared area.
15777346|NCT04635254|Other|Vehicle cream 48 hours|A 2 gram amount of vehicle cream will be applied under occlusion (TegaDerm tape) in a 4x4 cm squared area.
15777347|NCT04635254|Other|Histamine 1%|To deliver histamine, standard allergy skin prick test (SPT) lancets are applied. The lancets have a 1 mm shouldered tip adapt to introduce a small amount of test substance extremely locally and approximately at the dermo-epidermal junction.
15777348|NCT04635254|Other|Cowhage|The insertion of cowhage spicule(s) rapidly and consistently produces itch with no or very little flare reaction. This insertion is conducted by forceps using a stereo-microscope, and 30-35 spicules are gently rubbed into a 1 cm diameter skin area.
15777349|NCT04635241|Drug|Unfractionated heparin|Inhaled nebulised 6 hourly
15777350|NCT04635228|Device|Biodesign Otologic Repair Graft|The Biodesign Otologic Repair Graft is intended for use as grafting material for tympanic membrane perforation closure.
15777351|NCT04635215|Device|Sensura Mio Bodyfit technology ostomy pouches|The use of medical devices, the ostomy pouches from Sensura Mio Bodyfit technology range, will be studied from inclusion visit (less than one month after the beginning of use) and during 3 months.
15777352|NCT04635202|Behavioral|exercise training on elliptical device|This group (n=30) will receive aerobic training on an elliptical trainer for 16 weeks (3 sessions per week). The session will start with 5 minutes warming up at 50 % of maximal heart rate (MHR), 20-minute continuous ET at 70% of MHR, 12 minutes (4×3) intervals at 90% of MHR with a 3-minute active recovery at 70% of MHR between intervals, and finally 5-minute cool-down period at 50% of MHR
15777353|NCT04635202|Behavioral|group B (control group)|this group will receive general advises on maintaining physical activities for 16 weeks without any additional supervised training
15777354|NCT04635189|Drug|Daratumumab|Daratumumab 16 milligrams/kilograms intravenously weekly for 8 treatments, followed by every 2 weeks for 8 treatments, followed by every 4 weeks
15777355|NCT04635189|Drug|Lenalidomide|Lenalidomide 25 milligrams by mouth daily days 1-21 out of a 28 day cycle
15777356|NCT04635189|Drug|Dexamethasone|Dexamethasone 20 milligrams by mouth or intravenously at least 60 minutes prior to first infusion of daratumumab
15777357|NCT04635176|Drug|Real iPACK block (20 mL of 0.25% bupivacaine, 2.5mcg/mL epinephrine, and 50mcg/mL preservative-free dexamethasone)|real iPACK block with 20 mL of 0.25% bupivacaine, 2.5mcg/mL epinephrine, and 50mcg/mL preservative-free dexamethasone
15777358|NCT04635176|Drug|Sham iPACK block with 20ml normal saline|Sham iPACK block with 20 ml Normal saline
15777359|NCT04635163|Other|None intervention|None intervention
15777360|NCT04635150|Behavioral|Close Collaboration with Parents|Close Collaboration with Parents Training Program is an educational intervention for multidisciplinary NICU staff initially developed and implemented at Turku University Hospital to promote FCC. The intervention consists of four phases lasting 4 to 5 months each. First the healthcare staff learn to observe infant behavior. This phase aims at identifying the individual needs and features of each infant. After that, the staff observe infant behavior with the parents and learn to actively listen to parents' perceptions about their infant. During the phase III, staff learn to know the individual story of the family and their infant, which supports partnership between staff and parents. Finally, staff learn to integrate parents in decision-making and collaboratively plan the transition to home. The training is delivered through facilitator-network model in which local mentors are trained by the trainer mentors and supervisors.
15777361|NCT04635137|Procedure|Ablation and Cementoplasty|Percutaneous thermal ablation with subsequent cementoplasty in a single procedure
15777362|NCT04635124|Behavioral|Dog visit|An visitor visits the participant with a dog
15777363|NCT04635124|Behavioral|Encourage to engage in activity|In each visit the visitor invites the participant to engage in an activitty
15777364|NCT04635111|Drug|TURALIO™|This is a non-interventional, observational study to evaluate long-term risk of hepatic failure associated with TURALIO™ (pexidartinib) treatment. No study medication will be provided to the participants.
15777365|NCT04635098|Drug|dexmedetomidine|All participants will be randomly assigned to receive either dexmedetomidine or saline
15777366|NCT04635098|Drug|saline|All participants will be randomly assigned to receive either dexmedetomidine or saline
15777367|NCT04635085|Behavioral|Empowerment-based Cognitive behavioral therapy for insomnia for MCI|Participants in the intervention group will participate in a 12-week empowerment-based CBT-I comprising face-to-face sessions supplemented with telephone follow-ups. In total, six face-to-face sessions (90 minutes/session) will be conducted in a small group format with 6-8 participants in a group.
15777368|NCT04635072|Drug|Stabilised Whole Rice Bran|Patients with mild Atopic Dermatitis (AD) will be given SWRB in powder form, to be used as a cleanser after adding water to it according to set proportions given as instructions, once a day. Patients with moderate disease will use SWRB as a cleanser. In addition, they will also use SWRB as an emollient.
15777369|NCT04635059|Drug|Pacritinib|Pacritinib is an oral drug which will be taken daily on a 28-day cycle at a dose of 200 mg twice a day (BID).
15777370|NCT04635046|Procedure|Transfer or extirpation of the peroneus longs tendon|Tendon transfer or extirpation of peroneus longus or brevis tendon, ligamental reconstruction +/- calcaneal osteotomy
15777371|NCT04635020|Procedure|iStent|2 trabecular Stent injected at the end of the cataract surgery to the trabecular meshwork
15777372|NCT04635020|Procedure|SLT-laser|1 month after cataract surgery laser treatment to the trabecular meshwork (100 applications, 360 degrees)
15777373|NCT04635020|Procedure|Cataract surgery|Conventional cataract surgery
15777374|NCT04635007|Drug|Tranexamic acid|100 women: will receive preoperative 1 gram of TXA (kapron®, Amoun, Egypt) 10 minutes before skin incision, by slow intravenous injection over 10 minutes (Tranexamic acid injection will be prepared by diluting 1gm (10ml) TXA in 100 ml. of normal saline. TXA will be administrated as an intravenous infusion or slowly injection) and preoperative placebo (4 tablets similar to misoprostol in size and shape as peroxide) will be administrated rectally.
15777375|NCT04635007|Drug|Misoprostol 200mcg Tab|100 women: will receive preoperative 800 micrograms of misoprostol (4 tablets) rectally after spinal anesthesia and urinary catheterization (as per WHO dose recommendation) (Conde-Agudelo et al., 2013) and preoperative placebo (10 minutes before skin incision, 10 ml of distilled water ampoules by slow intravenous injection over 10 minutes).
15777376|NCT04634994|Drug|[F-18]SDM-8|PET radiopharmaceutical. Subjects will undergo [F-18]SDM-8 PET Scanning to measure synaptic density.
15777377|NCT04634981|Procedure|anesthesia of emergency cesarean section|compare General versus spinal anesthesia
15777378|NCT04634968|Behavioral|Brief Motivational Interviewing interaction|Telephone peer counselling+ Brief Motivational Interviewing interaction, and telephone-based interview after receiving all information.
15777379|NCT04634968|Behavioral|General health communication|Telephone peer counselling+ General health communication, and telephone-based interview, and telephone-based interview after receiving all information.
15777380|NCT04634955|Procedure|tranforaminal epidural injection|tranforaminal epidural injection which is performed by fluoroscopic guidance
15777381|NCT04634942|Device|Cryos REF 0971 Cold Spray|Cold Spray Coolant spray is manufactured from liquefied gases with high pressure. It acts by rapidly reducing the temperature in the body area where it is applied. The liquefied gas in the tube spreads on the skin in liquid form and takes the heat of the skin by turning into gas. The temperature of the area where it is applied drops from 30-32 degrees to 10-15 degrees. With the effect of the cold, the excitability of the nerve endings decreases, and thus the pain on the skin is felt by the person. Cold sprays, whose analgesic effect occurs immediately, are applied parallel to the muscle fibers in the area to be applied, from a distance of 15-45 centimeters, by squeezing for approximately 5-15 seconds. Cold sprays are suitable for long-term and multiple uses.
15777382|NCT04634942|Device|ShotBlocker BIONIX Press Firmly USA|ShotBlocker ShotBlocker is a plastic tool with a small and flat shape, with short and non-sharp protrusions on one side that connect with the skin. It resembles a horseshoe (C shaped) with its structure designed to expose the area to be injected. It is suitable for all age groups. It does not have any side effects. ShotBlocker can be used for both intramuscular and subcutaneous injections. The protruding surface of the ShotBlocker is held by pressing the skin during the injection and the process is performed from the part where the opening is.
15777383|NCT04634929|Procedure|bariatric surgery|bariatric surgery
15777384|NCT04634929|Dietary Supplement|conservative diet|conservative diet
15777385|NCT04634916|Device|EndoAVF Creation|Subjects will have an endoAVF created using the WavelinQ EndoAVF System
15777386|NCT04634903|Behavioral|Supportive Therapy SSI|Online, 30-minute self-administered program for youth
15777387|NCT04634903|Behavioral|Behavioral Activation SSI|Online, 30-minute self-administered program for youth
15777388|NCT04634903|Behavioral|Growth Mindset SSI|Online, 30-minute self-administered program for youth
15777389|NCT04634890|Behavioral|Exercise intervention|Supervised exercise intervention composed of mixed aerobic and strength activities, with the frequency of 3 sessions per week for 12 weeks, for a total number of trainings of 36.
15777399|NCT04634864|Device|Anodal tDCS|40 minutes of 2mA intensity direct current stimulation was delivered over both the right and left motor cortex simultaneously
15777400|NCT04634864|Device|sham tDCS|The stimulator was switched off after 2 minutes of stimulation.
15777401|NCT04634851|Behavioral|Virtual home visits|These participants will have a tailored evaluation of dietary choices based on their home dietary environment (refrigerator, pantry, etc). This will be conducted over video exchange.
15777402|NCT04634838|Device|MedCu Antibacterial Wound Dressings with Copper Oxide|Comparison between the efficacy of antibacterial wound dressings containing copper oxide microparticles to improve the wound healing of pressure sores and post-op wounds as compared to silver wound dressings
15777408|NCT04634799|Other|Placebo|Matching placebo will be provided and participants will take 6 tablets in the evening for up to 7 days.
15777409|NCT04634773|Radiation|Low-dose CT|"A low-dose, or quantitative (q) CT scan will be performed on the shoulder. This CT scan will be done to assess the bony structure of the shoulder, as well as bone strength, which can influence the health of the cartilage.
~Group 1 participants will complete this scan at baseline, 2-years and 4-years in the affected shoulder, and at baseline and 4-years in the opposite, unaffected shoulder.
~Group 2 participants will complete this scan at baseline, 2-years and 4-years."
15777410|NCT04634773|Other|T1Rho MRI|"A T1Rho MRI will be performed on the shoulder. This imaging technique uses a special sequence and will be used to assess the muscles and tendons around the shoulder.
~Group 1 participants will complete this scan at baseline, 2-years and 4-years in the affected shoulder, and at baseline and 4-years in the opposite, unaffected shoulder.
~Group 2 participants will complete this scan at baseline, 2-years and 4-years."
15777411|NCT04634773|Other|Motion Analysis|"Motion analysis is the study of how joints move and which muscles fire during specific movements. In the lab, participants will be asked to perform movements that they might do during a typical day or when exercising.
~Group 1 participants will complete this scan at baseline, 2-years and 4-years in the affected shoulder, and at baseline and 4-years in the opposite, unaffected shoulder.
~Group 2 participants will complete this scan at baseline, 2-years and 4-years."
15777412|NCT04634747|Drug|PVX-410|PVX-410 in combination with pembrolizumab and chemotherapy
15777413|NCT04634721|Drug|bupivacaine|In one arm the TAP infiltration will contain 10 mL of 0.25 % bupivacaine injected . This will then be repeated on the contralateral side.
15777414|NCT04634708|Other|No intervention|No intervention due to observational design
15777415|NCT04634682|Dietary Supplement|MYODM|Formulated composition containing Theobroma cacao supplemented with caffeine
15777416|NCT04634669|Drug|AXS-05 (dextromethorphan-bupropion)|- AXS-05 tablet, taken daily (up to 12 months)
15777417|NCT04634656|Drug|Lidocaine|Patients will receive lidocaine in a loading dose of 1 mg/ kg diluted in 10 ml of normal saline that will be infused over 5 minutes after induction of anesthesia then followed by a continuous infusion at 1.5 mg/ kg/ h diluted in normal saline to a volume of 50 ml until the end of surgery
15777418|NCT04634656|Drug|Normal saline|Patients will receive normal saline after induction of anesthesia with the same volume and rate changes as lidocaine group until the end of surgery
15777419|NCT04634643|Other|Usual diet and physical activity|Patients will be followed up to assess the effect of the usual diet and physical activity on development of NAFLD
15777420|NCT04634630|Genetic|Exposure to lung cancer stem cells|The exposure to lung cancer stem cells was measure as the percentage of Aldehyde dehydrogenase (ALDH) on all viable cells extracted from surgically resected tumor specimens
15777421|NCT04634617|Other|Questionnaire Administration|Complete questionnaires
15777424|NCT04634591|Procedure|Bariatric surgery|Bariatric surgery (Roux-en-Y gastric bypass, gastric banding, or sleeve gastrectomy) for the treatment of morbid obesity
15777426|NCT04634565|Drug|PF-06651600|oral PF-06651600 tablet 200 mg once daily
15777427|NCT04634552|Drug|Talquetamab|Talquetamab will be administered SC until disease progression.
15777428|NCT04634539|Drug|Gemcitabine|Gemcitabine will be administered at 600, 800, or 1000 mg/m2 intravenous (IV) infusion over 30 minutes on days 1, 8, and 15 (every 28-day cycles) during the treatment period. Gemcitabine will be administered immediately after the infusion of nab-paclitaxel. Pre-medication with may be administered per institutional standard practice at the investigator's discretion with gemcitabine.
15777429|NCT04634539|Drug|Nab-paclitaxel|Nab-paclitaxel will be administered at 75, 100, or 125 mg/m2 intravenous (IV) infusion over 30 minutes on days 1, 8, and 15 (every 28-day cycles) during the treatment period. Nab-paclitaxel will be given first, before infusion of gemcitabine. Pre-medication for nab-paclitaxel may be administered per institutional standard practice at investigator's discretion.
15777430|NCT04634539|Drug|L-glutamine|The dose levels of L-glutamine in this study will be 0.1, 0.2, and 0.3 g/kg oral twice daily (rounded to nearest 5 g with an upper limit of 15 g twice daily (30 g/day) for any dose level) taken at the same time each day during the treatment period. L-glutamine will be administered for 1 week (+/-1 day) prior to addition of gemcitabine/nab-paclitaxel. Each dose of L-glutamine should be mixed immediately before ingestion with 8 oz. (240 mL) of a cold or room temperature beverage, such as water, milk or apple juice, or 4 oz. (120 mL) to 6 oz. (177 mL) of food such as applesauce or yogurt. L-glutamine is formulated in 5 gram packets as a white crystalline powder in paper-foil-plastic laminate. Complete dissolution is not required prior to administration.
15777431|NCT04634513|Biological|strain CVD 1208S-122|Live, attenuated, vaccine strain of S. flexneri 2a expressing CFA/I and LT of enterotoxigenic E. coli
15777432|NCT04634513|Other|Placebo|Sodium bicarbonate buffer
15777433|NCT04634500|Drug|Dapagliflozin|Dapagliflozin Tablet
15777434|NCT04634487|Other|No intervention|No intervention
15777465|NCT04634175|Behavioral|Mind-body intervention|The mind-body intervention is composed of kundalini yoga techniques.
15777466|NCT04634175|Behavioral|Sham intervention|The sham intervention is composed of stretching and muscle flexion techniques.
15777435|NCT04634474|Behavioral|Suction|Is DAS an accurate pain descriptor for every application in intensive care unit?;. This question guides the study. This study was planned with the thought that the result may be misleading in applications such as eye care and aspiration that will trigger reflex movements in intensive care. In addition, creating new evidence on whether endotracheal suction is a painful application is the basis of the application.
15777436|NCT04634448|Procedure|Interval appendectomy|interval appendectomy at 2 to 3 months after the initial non-operative treatment
15777437|NCT04634448|Diagnostic Test|Follow-up MRI at 1 year|follow-up MRI at 1 year for asymptomatic patients under 35 years of age not wanting to undergo surgery
15777439|NCT04634422|Procedure|Plasma exchange and convalescent plasma|In addition to standard care, participants will receive 2 plasma exchange procedures max. 30 hours apart using the membrane or centrifuge method. PLEX will be initiated within 30 hours of randomization. The exchange volume of 60 mg of plasma per kg body weight will be substituted with albumin 5% and Ringer/saline 50% at the beginning followed by 50% FFP towards the end of the procedure. At the end of the 2nd procedure, participants will receive additional 2 units of CCP (equalling 600 ml CCP) with an administration rate of 100 to 250 ml/hr. Anticoagulation may be provided by citrate or by heparin but it is suggested that in patients with active bleeding regional citrate anticoagulation be utilized. PLEX may be performed via a central venous catheter if patient is deemed unsuitable for peripheral venous access, the latter is recommended. Possible SAE related to PLEX+CCP will be recorded as air embolism, anaphylaxis, TRALI and reported as an outcome.
15777440|NCT04634409|Drug|LY3819253|Administered IV.
15777441|NCT04634409|Drug|LY3832479|Administered IV.
15777442|NCT04634409|Drug|Placebo|Administered IV.
15777443|NCT04634409|Drug|VIR-7831|Administered IV.
15777444|NCT04634409|Drug|LY3853113|Administered IV.
15777445|NCT04634396|Behavioral|ACT Acceptance and Commitment Therapy|6 weeks of 1 hour sessions with a masters prepared research specialist to deliver validated tools
15777446|NCT04634383|Device|WFMA - wireless floating microelectrode array|Wirelessly transmitted patterns of electrical stimulation will be delivered to the visual cortex of study participants to generate visual percepts.
15777447|NCT04634370|Biological|Natural Killer Cells infusion|"Each patient will receive on dose of intravenous natural killer cell in following levels:
~Level 1 : 1x106 cells/kg body weight (patients 1 to 3) Level 2: 5x106 cells/kg body weight (patients 4 to 6) Level 3: 1x107 cells/kg body weight (patients 7 to 24)"
15777448|NCT04634357|Drug|ET140203 T Cells|"Biological/Vaccine: ET140203 autologous T-cell product
~Autologous T cells transduced with lentivirus encoding an ET140203 expression construct"
15777450|NCT04634331|Behavioral|Augmented Reality Multi-Modal Training|Training administered via an augmented reality headset.
15777451|NCT04634331|Behavioral|Traditional Multi-Modal Training|Training administered via a 1:1 physical therapy session
15777452|NCT04634318|Other|Respiratory rehabilitation program (RR).|"Patients in the RR group will follow the respiratory rehabilitation program during a 4-week hospitalization in the respiratory diseases department of Renée Sabran hospital (Hyères, France).
~The program includes for each week:
~One medical consultation Four 40-min sessions of aerobic exercises on an ergocycle Four 1-hour sessions of walking in Renée Sabran Hospital's park Three 1-hour sessions of muscle strengthening exercises One 1-hour session of sophrology One 1-hour session of occupational therapy One 1-hour session of psychomotricity"
15777453|NCT04634318|Other|Respiratory tele-rehabilitation program (TRR).|Patients in the TRR group will realize the 4-week respiratory tele-rehabilitation program at home. The TRR program for each week includes the same sessions as RR program. But, medical consultation, sophrology, occupational therapy, psychomotricity and muscle strengthening sessions are carried out through live videoconferences. Additionally, aerobic and walking sessions are carried out outside home. The intensity of each session will be controlled by heart rate monitor.
15777454|NCT04634305|Procedure|Total elbow arthroplasty|Total elbow arthroplasty by a single operator
15777455|NCT04634292|Behavioral|EEG|EEG + walking task + auditory task
15777456|NCT04634279|Behavioral|Collaborative care Plus|Collaborative care consists of a team of providers that includes a care coordinator, a primary care provider (PCP) and a behavioral health consultant (BHC), who provide evidence- and measurement-based care to a panel of patients using a clinical registry. In this model, the CC team also includes a behavioral health psychotherapist (BHP) who consults on a regular basis but does not deliver direct care. In the Collaborative Care Plus condition, the care coordinator involves family in care, teaches family about naloxone use, and provides Caring Contacts, a suicide prevention method, to patients.
15777457|NCT04634266|Device|Transcatheter tricuspid valve treatment (TTVT)|Percutaneous CE-mark approved techniques for transcatheter tricuspid valve treatment (TTVT): These include (I) transcatheter annuloplasty devices (Tricuspid Cardioband) and (II) transcatheter edge-to-edge repair (TriClip, PASCAL).
15777460|NCT04634240|Procedure|Percutaneous Coronary Intervention (PCI)|PCI of all qualifying lesions.
15777461|NCT04634227|Drug|Ascorbate|Following 15g test dose, 75g administered 75g dose on days 1 and 2. Further doses of ascorbate will be determined by serum ascorbate levels measured by the end of the week to reach a target serum concentration between 20 -30 mM. Ascorbate doses will continue to be escalated until either the target serum concentration or maximum dose of 125 g is administered.
15777462|NCT04634201|Dietary Supplement|Oral probiotics (L. reuteri)|administration of probiotic containing tablets twice daily after tooth brushing for 3 months
15777463|NCT04634201|Dietary Supplement|Placebo|administration of a placebo twice daily after tooth brushing for 3 months
15777464|NCT04634188|Diagnostic Test|Procalcitonin|Samples were categorized based on demographic data (age and gender), then the samples were categorized based on the type of brain tumor suffered. Once categorized, the levels of inflammatory markers was examined. Specimens were taken from the patient's peripheral blood examination and analyzed in laboratorium. The results of these examinations are grouped on a nominal scale, and analyzed statistically
15777467|NCT04634162|Drug|Cangrelor|Cangrelor will be used at the FDA recommended dose using a 30 μg/kg bolus followed by 4 μg/kg/min infusion. The duration of cangrelor/placebo infusion will be 2 hours. After completing the first phase of the study, patients will undergo a 1-4 week wash-out period and then will cross-over to the alternative treatment in the second phase
15777468|NCT04634162|Drug|Placebo|Normal saline will be infused for 2 hours. After completing the first phase of the study, patients will undergo a 1-4 week wash-out period and then will cross-over to the alternative treatment in the second phase
15777469|NCT04634149|Biological|BMS-986036|Specified dose on specified days
15777470|NCT04634136|Diagnostic Test|Lab tests|CBC and differential counts, blood electrolytes, magnesium, calcium, phosphorus, urea & creatinine, liver enzymes (AST, ALT, gGT)
15777471|NCT04634136|Diagnostic Test|ECG|Electrocardiogram
15777472|NCT04634136|Diagnostic Test|Cannabinoid Levels|Determination of levels of cannabidiol (CBD) and delta-9-tetrahydrocannbinol (THC) for determination of levels at following time(s) after ingestion: 0, 1, 2, 4, 8 and 24 hours.
15777473|NCT04634136|Drug|Full-spectrum Medical Canabis Product (HemPhar)|Active substance
15777474|NCT04634136|Drug|Placebo|Placebo
15777475|NCT04634136|Diagnostic Test|Spasticity level according to modified Ashworth scale (Bohannon)|"A trained physiotherapist will assess spasticity level according to modified Ashworth scale (Bohannon), which is 6-level scale for assessment of spasticity.
~Modified Ashworth/Bohannon Scoring Scale (Bohannon and Smith, 1987):
~0 No increase in muscle tone
~Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the remainder (less than half) of the range of movement (ROM )
~More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved
~Considerable increase in muscle tone, passive movement difficult
~Affected part(s) rigid in flexion or extension
~Best score is 0 (no spasticity), worst score is 4 (severe spasticity)."
15777476|NCT04634136|Diagnostic Test|Gross Motor Function Measure|"A trained physiotherapist will assess Gross Motor Function Measure (GMFM-88) which is commonly used in the evaluation of gross motor function in children with cerebral palsy
~The Gross Motor Function Measure-88 (GMFM-88) is a standardized observational instrument developed to measure change in gross motor function over time. The test consists of 88 items categorized in five dimensions (Dimension A: lying and rolling, Dimension B: sitting, Dimension C: crawling and kneeling, Dimension D: standing and Dimension E: walking, running and jumping). The test was conducted as described in the GMFM-88 manual . A percentage score as compared to maximum is calculated for each dimension and for the total score of the five dimensions.
~Reference curves exist for GMFM-88 for each age group.
~Floor score is 4 (minimum score / worst), ceiling score (maximum score / best) is 75."
15777477|NCT04634123|Other|Pulpotomy therapy by White Portland Cement|Carious asymptomatic primary anterior teeth will be removed of dental caries likely to produce vital pulp exposure . The access will be refined using a sterile no. 4 or 6 round bur in a slow-speed handpiece . The remaining pulp will be treated using pulpotomy therapy by White Portland Cement
15777478|NCT04634123|Other|Pulpotomy therapy by White MTA|Carious asymptomatic primary anterior teeth will be removed of dental caries likely to produce vital pulp exposure . The access will be refined usinga sterile no. 4 or 6 round bur in a slow-speed handpiece . The remaining pulp will be treated using pulpotomy therapy by White MTA
15777479|NCT04634110|Drug|Brigatinib|At day 1, all patients will be started on brigatinib 90 mg daily for 7 days, before escalating to 180 mg daily thereafter as tolerated.
15777480|NCT04634097|Other|Experimental group|"Clusters will be proposed LE DECLIC EPRI intervention, which is a complex intervention, associating 3 components,:
~A. DECLIC program set up in the centers, open to concerned patients.
~B. 3 training sessions :
~one public of primary care physicians in order to give them the opportunity to be involved in the medical care in charge of the patient suffering from cancer pain.
~one public of cancer physicians, leaders of opinions in each cancer centers participating to the study and one public of health professionals in order to train them to be educators (team building).
~for healthcare professionals in order to train them as educators in this program.
~C. The collaboration of one primary care network, specialized in pain management, in order to reinforce the patient care pathway."
15777481|NCT04634097|Other|standrad group|Standard follow-up patient related to pain. Specific to each center : with or without existing local ETP program (standard care).
15777482|NCT04634084|Procedure|Experimental group(Bursa Implantation)|Prior to all rotator cuff repairs, a subacromial bursectomy is performed with an oscillating shaver so that the rotator cuff can be visualized and repaired.In the experimental group, instead of being discarded, this minced bursal tissue will be collected via a sterile filtration device attached to the oscillating shaver. The bursal tissue is then placed into a sterile syringe, and reimplanted back onto the bursal surface of the rotator cuff repair at the completion of the case. The arthroscopic fluid is turned off, and fluid is evacuated from the shoulder prior to reimplantation of the bursa.. Nothing is added to the bursa prior to reimplantation. There are no reagents. The bursa tissue is purely the minced bursa tissue removed from the patient, and never leaves the sterile field.
15777483|NCT04634084|Procedure|Control Group(Standard of Care)|Prior to all rotator cuff repairs, a subacromial bursectomy is performed with an oscillating shaver so that the rotator cuff can be visualized and repaired.The current standard of care procedure is to discard this tissue, and then proceed with the rotator cuff repair
15777484|NCT04634071|Drug|Varenicline|Varenicline therapy will be 12-week course. On days 1-3 participants will receive 0.5mg once daily; days 4-7 receive 0.5mg twice daily and day 8 until the end of treatment receive 1mg twice daily.
15777485|NCT04634071|Drug|Bupropion|Patients will begin with a dose of 150 mg every morning for 3 days. Then dosage will increase to 150 mg twice daily (morning and evening), for a total daily dose of 300 mg, for 7 to 12 weeks.
15777486|NCT04634071|Drug|Long-acting nicotine replacement therapy|Nicotine replacement therapy (NRT) patches will be used daily from 1-10 weeks depending on participant's smoking history.
15777487|NCT04634071|Behavioral|Low-intensity counseling|A study coordinator or a member of the treatment team will provide a minimum level of initial counseling, approximately 10-20 minutes in length.
15777488|NCT04634071|Behavioral|High-intensity counseling|A counselor will provide eight sessions in the first 8 weeks of the study. Up to three follow up sessions over the next 4 months of study will be encouraged, but not required.
15777489|NCT04634071|Other|No nicotine replacement therapy|Participants in this group will not receive per required need nicotine replacement therapy.
15777490|NCT04634071|Drug|Nicotine Replacement Products|Participants in this group will receive per required need nicotine replacement therapy.
15777491|NCT04634058|Drug|PD-L1 antibody combined with CTLA-4 antibody|After 4 cycles of PD-L1 monoclonal antibody combined with CTLA-4 monoclonal antibody treatment, PD-L1 monotherapy was maintained until the disease progressed or intolerable toxicity and adverse reactions or the medication was used for two years.
15777493|NCT04634032|Genetic|mRNA expression and SNP analysis|mRNA expression and SNP analysis from samples
15777494|NCT04634032|Diagnostic Test|Blood sampling|Peripheral blood sampling for SNP analysis
15777495|NCT04634019|Behavioral|Financially incentivized knowledge assessments|We will conduct quarterly provider knowledge assessments at selected health facilities and will pay facilities a financial bonus if providers perform well on these tests. For the intervention, 12 clinical vignettes were created. These vignettes cover typical patient cases such as malaria, diarrhea and respiratory infections, and assess providers' ability to correctly diagnose and treat hypothetical questions. All medical staff members will be informed hat every 3 month there will be a knowledge assessment based on these vignettes and that the results will determine the total bonus payment made to the facility.
15777496|NCT04634006|Device|Home-based transcranial direct current (tDCS) device|tDCS is a brain electrostimulation technique that consists of applying a current of low intensity (between 1 and 2 mA) on the scalp via two electrodes in order to modify the cerebral activity of the stimulated zones. Twenty sessions (active/sham) will be self-administered by parent or caregiver on twenty consecutive business days. The parameter of electrode size, current strength and current duration were previously tested for safety in children. The investigators use the Soterix Medical tDCS devices of the home-based miniCT 1x1 type.
15777497|NCT04633993|Behavioral|PCSMP|This study divided the patient-centered self-management manual for patients with hypertensive nephropathy into 4 units, including: Unit 1: hypertensive nephropathy brief introduction and complications. Unit 2: dietary precautions for patients with hypertensive nephropathy. Unit 3: medication treatments for patients with hypertensive nephropathy. Unit 4: the content included stress management (emotional control, spiritual support). This program was implemented in small groups with 5-10 patients. This study used patient-centered self-management group activity manual as the tool. The group activities with 4 units lasting for 400 minutes were expected to be designed. The group activities were expected to last for 4 weeks and be implemented once per week and 100 minutes per time (including: 90 minutes of group discussion and 5-10 minutes of video-waring).
15777498|NCT04633980|Drug|Mixture 3,6% H2 in N2 (96.4%)|Route of administration: intra-nasal Debit 1L/min, 24h/24h (3 hours withdrawal tolerated) duration of treatment: 24 hours, 3 days and 6 days
15777499|NCT04633967|Drug|Alemtuzumab Injection|"This observational study is collecting clinical data focusing on infusion associated reactions and changes in vital signs in MS patients Novel Infusion protocol: The protocol consisted of the following Pre-infusion Protocol
~Premedication with an H1 and H2 blockade (ranitidine or similar, loratadine or similar) for 7 days prior to the infusion.
~Premedication with 50 mg of prednisone orally for 5 days before the infusion.
~During Infusion Protocol During infusions methylprednisolone is administered in a dosage of 500 mg on every day of the infusion.
~Post Infusion Medication
~Post-medication with an H1 and H2 blockade (ranitidine or similar, loratadine or similar) for 7 days after the infusion.
~Post-medication with 50 mg of prednisone orally for 5 days after the infusion.
~Medications to be used PRN throughout the peri-infusion protocol Benadryl, acetaminophen or other analgesics were allowed"
15777500|NCT04633954|Drug|Brimonidine Tartrate 0.15% Oph Soln|One drop of Brimonidine Tartrate 0.15% Oph Soln prior to FLACS
15777501|NCT04633941|Other|Standard Care|Standard Care
15777502|NCT04633928|Biological|N-TEC: Autologous nasal chondrocytes and ECM proteins|Cells expanded in vitro and cultured in a collagen type I//III scaffold
15777503|NCT04633902|Drug|Olaparib|Olaparib 300 mg BID daily
15777504|NCT04633902|Drug|Pembrolizumab|Pembrolizumab 200 mg IV eveyr 3 weeks (for up to 2 years)
15777505|NCT04633889|Drug|Deferoxamine|Deferoxamine 30mg/kg (max dose, 6g) intravenous infusion (diluted in 240mL normal saline) administered over 12 hours
15777506|NCT04633889|Drug|Normal saline|Normal saline (240mL) intravenous infusion over 12 hours
15777507|NCT04633876|Behavioral|Individual coaching|Individual coaching on lifestyle change, sleep, nutrition, physical activity and stress management.
15777508|NCT04633876|Behavioral|Group coaching|Group coaching on lifestyle change, sleep, nutrition, physical activity and stress management.
15777509|NCT04633876|Other|Control group|Group receives no lifestyle coaching but did get baseline results from assessments which might motivate for lifestyle change.
15777510|NCT04633863|Device|Artificial tear MDI - 101|Medical device CE marked - artificial tears containing arabinogalactan, trehalose and hyaluronic acid - 10 weeks treatment
15777511|NCT04633850|Drug|Dexamethasone|Intravenous dexamethasone 8 mg. Given once at the end of surgery.
15777512|NCT04633850|Drug|Bupivacain|"Bupivacaine dose according to weight. <60 kg: Total dose 100mg 60-90kg: Total dose 150mg >90kg: Total dose 200mg
~Given once at the end of surgery."
15777513|NCT04633837|Device|Extracellular Matrix Graft Injectable Implant|The extracellular matrix injectable implant will serve as the intervention in this study.
15777514|NCT04633824|Other|Retrospective Electronic Medical Record Review|Patients will be assessed retrospectively for evidence of successful or failed epidural extension in the setting of need for cesarean section
15777515|NCT04633811|Dietary Supplement|Low Oxalate Diet|Subjects will be instructed to ingest a controlled diet low in oxalate for a total of 7 days
15777545|NCT04633577|Drug|Lidocaine Iv|A bolos of 1.5mg/kg lidocaine will be administered before induction. Then, infusion of 4mg/kg/h lidocaine will maintain during procedure.
15777516|NCT04633811|Dietary Supplement|Oral load of oxalate and sucralose|Subjects will ingest 4 mmoles of sodium oxalate, which includes 50mg carbon-13 oxalate, and 5 grams of sucralose on the last day of the 7-day low oxalate diet phase. Following the oral load, blood and urine will be collected every 30 minutes and hourly, respectively
15777517|NCT04633811|Dietary Supplement|Optifast VLCD Program|Subjects will go on a 12-week Intestive level Optifast VLCD weight loss program
15777518|NCT04633811|Dietary Supplement|Optifast VLCD Transition Phase|After completion of the 12-week Optifast VLCD Program, subjects will be weaned off the Optifast products for 2 weeks.
15777519|NCT04633798|Procedure|IPL/Lipiflow|To treat patients with MGD using intense pulsed light combined with lipiflow
15777520|NCT04633798|Procedure|IPL/MGX|To treat patients with MGD using intense pulsed light combined with meibomian gland massage
15777521|NCT04633785|Other|No Intervention|There are no interventions in this study. The mercury sphygmomanometer and the wrist sphygmomanometer will be used in this study to collect blood pressure values from the study subjects.
15777522|NCT04633772|Drug|Angiotensin-(1-7)|Intravenous supplementation of Angiotensin-(1-7)
15777523|NCT04633772|Drug|Placebo|NaCl 0.9%
15777524|NCT04633759|Other|Blood Flow Restriction Exercise|Following a 5-minute low intensity warm-up, the BFR cuff will be placed at the most proximal portion of the leg and dosed following standard BFR guidelines: 1 set of 30 reps, then 3 sets of 15 reps at 20-30% 1RM with up to 80% limb occlusion. Exercises will target bilateral 1) knee and hip extension, 2) hip abduction, and 3) ankle plantarflexion, as these muscles are important for functional mobility in people with MS.
15777525|NCT04633746|Diagnostic Test|measuring plasma Endostatin level|measuring plasma Endostatin level at the time of admission then after 48hrs and 96 hours
15777526|NCT04633733|Drug|HL237 tablet|HL237 400mg will be administered orally twice a day.
15777527|NCT04633733|Drug|tacrolimus capsule|tacrolimus 5mg will be administered orally once a day.
15777528|NCT04633720|Other|Changes in positive end-expiratory pressure and tidal volume|"When the patient is in the supine position 10 minutes after induction of anesthesia, the following 4 mechanical ventilator settings are applied to the patients in order.
~Positive end-expiratory pressure 8 cmH2O, tidal volume 8 ml/kg Positive end-expiratory pressure 10 cmH2O, tidal volume 5 ml/kg Positive end-expiratory pressure 10 cmH2O, tidal volume 8 ml/kg Positive end-expiratory pressure 12 cmH2O, tidal volume 5 ml/kg"
15777529|NCT04633707|Device|adjunctive bright white light therapy in the morning|the participants would receive adjunctive bright white light therapy in the morning (light intensity: 10000lux, color: white light, duration of each intervention session: 30min, time period: 7:00~9:00) for 6 weeks.
15777530|NCT04633707|Device|adjunctive bright white light therapy in the afternoon|the participants would receive adjunctive bright white light therapy in the afternoon (light intensity: 10000lux, color: white light, duration of each intervention session: 30min, time period: 12:00~14:00) for 6 weeks.
15777531|NCT04633707|Device|adjunctive dim red light therapy in the afternoon|the participants received dim red light therapy (light intensity: <100lux, color: dark red, duration of each intervention session: 30min, time period: 12:00~14:00) for 6 weeks.
15777532|NCT04633694|Dietary Supplement|insect, pea or whey protein|The protein powder is dissolved in 400 mL water and given relative to lean body mass, 0.25 g protein pr kg lean body mass.
15777533|NCT04633681|Dietary Supplement|Sweetener and sweetness enhancer consumption|Two-week consumption of combinations of different sweetener and sweetness enhancer blends in reformulated food products compared to sucrose containing product.
15777534|NCT04633668|Behavioral|CBT for parasomnias (CBT-p)|Psychoeducation, sleep hygiene, imagery re-scripting, scheduled awakenings, safety planning, cognitive therapy, and stress management for 6 weeks
15777535|NCT04633668|Behavioral|Self-Monitoring|Monitoring of sleep quality through sleep diary, actigraphy, nightmare experiences for 6 weeks
15777536|NCT04633655|Other|outcome measures for CIPN testing|questionnaires administration, physician based scales for CIPN data collection
15777537|NCT04633642|Procedure|Ultrasound group|Every week during a six-week treatment period
15777538|NCT04633642|Procedure|Surgical group|Every week during a six-week treatment period
15777539|NCT04633629|Other|Lung ultrasound|We will perform daily a lung ultrasound to evaluate pulmonary congestion by counting B-lines.
15777540|NCT04633616|Other|Tailored Patient-Provider Communication|Every 1.5 months, patients randomized to the tailored patient-provider communication model will receive weblinks directing patients to disease-specific educational videos and associated questionnaires. Communication will be tailored as the mode of weblink delivery will be customized to patient preference. Patients can choose messages to be delivered via e-mail, SMS, WhatsApp, or Facebook. For example, if one patient determines SMS messaging as their preferred communication mode, then this patient will receive a weblink via SMS directing the patient to customized educational videos and questionnaires. Weblinks delivered via tailored patient-provider communication will be enabled by Wecudos.
15777541|NCT04633616|Other|Non-Tailored Patient-Provider Communication|Every 1.5 months, patients randomized to the non-tailored patient-provider communication model will receive weblinks directing patients to disease-specific educational videos and associated questionnaires. Communication will be non-tailored such that patients will not be able to choose their preferred mode of communication and will receive hardcopy. Patients will receive hardcopy on how to access psoriasis education. Weblinks delivered via non-tailored patient-provider communication will be enabled by Wecudos.
15777542|NCT04633603|Device|FeverFriend mobile application|Registration, documentation of patients profile, documentation of fever events, following advice regarding the patient and the care-giver, documentation of follow up notifications.
15777543|NCT04633590|Behavioral|Home-based exergaming|Participants will undertake one of two 6-week training interventions. In both groups participants will be asked to train at least 3 times per week (18 sessions total), during which adherence to the training will be measured. To monitor adherence to training and training load (duration and heart rate achieved during workouts) throughout the 6 weeks participants will be given a heart rate monitor.
15777544|NCT04633590|Behavioral|gym-based training|Participants will undertake one of two 6-week training interventions. In both groups participants will be asked to train at least 3 times per week (18 sessions total), during which adherence to the training will be measured. To monitor adherence to training and training load (duration and heart rate achieved during workouts) throughout the 6 weeks participants will be given a heart rate monitor.
15777546|NCT04633577|Drug|0.9% normal saline|0.9% normal saline
15777547|NCT04633564|Biological|Bevacizumab as MYL-1402O|Bevacizumab as MYL-1402O 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV
15777548|NCT04633564|Biological|Bevacizumab as Avastin|Bevacizumab as Avastin 15 mg/kg IV + Carboplatin AUC 6 IV+ Paclitaxel 200 or 175 mg/m2 IV
15777549|NCT04633551|Dietary Supplement|Anti-inflammatory supplement|commercially available combination of curcumin, quercitin, resveratrol, and green tea
15777550|NCT04633538|Device|Smartphone app|Use of smartphone app to measure 6 minute walk test (6MWT)
15777551|NCT04633525|Procedure|Optimum Cup Orientation|Participants will have X-rays taken before surgery to determine the target optimal zone for orientation of the cup implant, using EBRA software. The surgeon may or may not implant in this target zone, depending on what they believe is in the patient's best interest. X-rays will be taken at 12 months after surgery to determine if they target cup orientation was achieved.
15777552|NCT04633512|Device|ActivSight|Use of ActivSight in patients undergoing laparoscopic or robot assisted intestinal anastomoses and patients undergoing laparoscopic or robot assisted cholecystectomy.
15777553|NCT04633499|Behavioral|Social Cognition Task|Two paradigms will be tested: visual perspective taking and reading the mind in the eyes.
15777554|NCT04633499|Device|tDCS|tDCS either over the dmPFC or the rTPJ.
15777555|NCT04633486|Diagnostic Test|zoom-endoscopy|Endoscopic monitoring of intestinal transplant recipients is done with zoom-endoscopes for exact diagnostic of intestinal mucosa.
15777556|NCT04633473|Behavioral|SIB-Time Web-Application Tool|Parent-child dyads will use the SIBTime app in a 4-week intervention to test its relevance, acceptability, cultural appropriateness, and potential for efficacy.
15777557|NCT04633460|Dietary Supplement|Ketone ester|A nutraceutical ketone ester (KE), (R)-3-hydroxybutyl (R)-3-hydroxybutyrate which provides systemic ketosis
15777558|NCT04633460|Dietary Supplement|placebo drink|KE free placebo drink
15777561|NCT04633434|Device|The Talk Parenting Skill for Alexa|In a 6-week session, families will use at home a prototype Bedtime Routine module of the Talk Parenting program, a smart speaker app designed to provide parents with in-situ experiential support for building positive family routines. The prototype Bedtime Routine module of Talk Parenting will guide families in creating a healthy bedtime routine to foster healthy sleep habits, provide experiential practice in self-regulation skills, and promote a positive parent-child relationship.
15777562|NCT04633421|Dietary Supplement|PRECISe protocol EN 8g protein/100kcal|Enteral feed containing 8g protein/100kcal
15777563|NCT04633421|Dietary Supplement|PRECISe protocol EN 5g protein/100kcal|Enteral feed containing 5g protein/100kcal
15777564|NCT04633408|Behavioral|STAR-C Virtual Training and Follow-up (STAR-VTF)|STAR-C Virtual Training and Follow-up (STAR-VTF) is adapted from an evidence-based, in-person program that trains family caregivers to manage BPSD (behavioral and psychological symptoms of dementia)
15777565|NCT04633395|Other|Music|The participant can choose between 5 different soothing playlists
15777566|NCT04633395|Behavioral|Sleep hygiene|These are behavioural guidelines to help establish a better sleep pattern
15777567|NCT04633382|Combination Product|Enhanced recovery after biliary tract surgery|Patients with malignant and benign diseases of the bile ducts, who have formed various types of anastomosis in two options for managing the postoperative period: traditional and based on the principles of enhanced recovery after surgery
15777568|NCT04633369|Dietary Supplement|dietary fibers|during days 13-22 the participants will consume the dietary fiber according to their randomization and continue fasting. Participants will be asked to collect stool and oral samples 4 times during this period.
15777569|NCT04633356|Device|EUS-portal pressure gradient measurement (PPGM)|EUS-guided PPGM is performed under conscious sedation. An OGD would be performed to evaluate for findings consistent with portal hypertension such as varices and portal hypertensive gastropathy. The linear array echoendoscope is passed from the mouth into the stomach and duodenum, as with a standard exam. Under endoscopic ultrasound guidance, a 25 gauge EUS needle (Echotip, Cook Medical, USA) primed with heparin 100 USP/ml is then placed across the stomach or duodenal wall and through the liver parenchyma into the portal vein. A pressure measurement is then obtained from the compact pressure transducer attached to the handle of the needle. Three separate measurements are made with re-priming of heparin (less than 0.5 ml). The process is repeated for the hepatic vein. The EUS - PPG is calculated by subtracting the average of the three hepatic vein pressure measurements from the average of the 3 direct portal vein pressure measurements.
15777570|NCT04633343|Other|Small volume breath and fast breathing rate for 5 minutes|Small volume breath and fast breathing rate delivered via mechanical ventilator.
15777571|NCT04633343|Other|Large volume breath and slow breathing rate for 5 minutes|Large volume breath and slow breathing rate delivered via mechanical ventilator.
15777572|NCT04633330|Drug|AHCC®capsules|AHCC®capsules, a standardized extract of cultured Lentinula edodes mycelia (ECLM) TID for 6 months after enrolment.
15777573|NCT04633330|Drug|Simulation of AHCC®capsules|TID for 6 months after enrolment. A compensation of AHCC®is provided to participant from control arm when HR-HPV positive at 6 months after enrolment.
15777574|NCT04633317|Device|A pneumatic nebulizer|Inhaled colistimethate sodium generated by a pneumatic nebulizer
15777575|NCT04633317|Device|A vibrating mesh nebulizer|Inhaled colistimethate sodium generated by a vibrating mesh nebulizer
15777576|NCT04633304|Device|EndoAVF System for endovascular AV fistula creation|AV fistula creation
15777577|NCT04633291|Device|CP279|catheterisations.
15777578|NCT04633278|Drug|CMP-001|Subjects will receive CMP-001 10mg IT weekly for 7 doses after which CMP-001 will be administered every 3 weeks. The first dose of CMP-001 may be administered subcutaneously (SC) or IT at the discretion of Investigator. All subsequent doses will be IT every 3 weeks (Q3W).
15777579|NCT04633278|Drug|Pembrolizumab|Pembrolizumab 200 mg IV is administered Q3W.
15777580|NCT04633265|Device|ECG-I Mapping of Atrial Fibrillation|Catheter ablation of Atrial Fibrillation guided by ECG-I
15777581|NCT04633252|Drug|ADT|For mCSPC patients: Androgen Deprivation Therapy (ADT) may include GnRH agonist or monthly degarelix converted to GnRH agonist after 3 months. For mCRPC patients: ADT will be continued as per standard of care.
15777649|NCT04632875|Behavioral|Loving-Kindness Meditation|Approximately 15-minute sessions are administered 6 days per week
15777582|NCT04633252|Drug|Prednisone|For mCSPC patients, prednisone is optional and if given, should be taken orally, at 5 mg once a day. For mCRPC patients, prednisone should be taken orally either, at 5mg twice a day for each dose or 10 mg once a day as is the patient s preference.
15777583|NCT04633252|Drug|M7824|M7824 (2400 mg) will be administered as a 1 hour intravenous (IV) infusion once every three weeks.
15777584|NCT04633252|Drug|Docetaxel|Docetaxel 75mg/m^2 will be administered intravenously every 21 days (i.e., a 3-week cycle) for up to 6 cycles in mCSPC and until progression or unacceptable toxicity in mCRPC.
15777585|NCT04633252|Drug|M9241|M9241 at escalating doses and then at RP2D will be administered as a subcutaneous injection every three weeks.
15777589|NCT04633213|Drug|HBM9036 0.25% Ophthalmic Solution|Ophthalmic Solution
15777590|NCT04633213|Drug|Placebo|Ophthalmic Solution
15777591|NCT04633200|Other|DOT mobile app|DOT is a mobile phone app that has daily pill reminders and supportive texts, as well as various features designed to support PrEP medication adherence.
15777592|NCT04633187|Drug|EDP-938|Subjects will take EDP-938 tablets (800 mg) once a day orally for 21 days
15777593|NCT04633187|Drug|Placebo|Subjects will take EDP-938 matching placebo tablets once a day orally for 21 days
15777594|NCT04633174|Device|Sous Vide Device (SVD)|A basin will be filled to the marked line with water from jugs at room temperature, for each frozen extremity. The sous vide device (SVD) will be attached to the distal edge of the basin. The SVD will be turned on and set to maintain the bath at a constant 38 degrees celsius for 30 minutes duration. The thermometers will be powered on continuously and the researcher will record temperatures simultaneously from each thermometer every 2 minutes. At the end of the 30 minute treatment, the SVD will be powered off and the extremity assessed by the researcher for warmth and pliability. If the extremity still feels cold or frozen, an additional 30 minutes in the water bath will commence, with subsequent reassessment. Rewarming will be considered complete when the affected tissue becomes red or purple, soft, and pliable.
15777595|NCT04633148|Drug|Cyclophosphamide (Non-IMP)|Intravenous infusion for 3 days
15777596|NCT04633148|Drug|Fludarabine (Non-IMP)|Intravenous infusion for 3 days
15777597|NCT04633148|Drug|UniCAR02-T-pPSMA|Intravenous Infusion for 24 days
15777598|NCT04633148|Drug|UniCAR02-T (IMP)|Intravenous infusion of single dose
15777599|NCT04633135|Device|Philips stove|Philips Smokeless stove HD4012LS
15777600|NCT04633135|Device|Gyapa stove|Wood stove made in Ghana
15777601|NCT04633122|Drug|Ripretinib|Oral kinase inhibitor
15777602|NCT04633122|Drug|Sunitinib|second-line therapy in GIST patients who have progressed after imatinib treatment or are intolerant to imatinib
15777603|NCT04633109|Procedure|taste bud biopsy|Taste buds will be surgically removed a) during a planned and medically induced elective surgery under full anesthesia; b) by local anesthesia in subjects without a medically induced surgery
15777604|NCT04633109|Diagnostic Test|oral glucose tolerance test|75g glucose will be applied in drinking water following blood sample collection to evaluate glucose, insulin and C-peptide level.
15777605|NCT04633109|Diagnostic Test|Taste sensitivity|Subjects are given taste strips with 4 concentrations per each taste quality of sweet, sour, salty, bitter and umami in a pseudo-randomized manner. Subjects are asked to identify the taste quality, state the intensity, preference and certainty.
15777606|NCT04633109|Diagnostic Test|olfactory function|Subjects will be presented 16 different sniffing sticks in a randomized order, each for about 4seconds. People are then asked to identify the smell by choosing one out of 4 options (forced choice).
15777607|NCT04633109|Diagnostic Test|taste bud density|The number of taste buds on the anterior tongue will be determined by colouring the tongue surface with food colour. Taste buds will apply more reddish as compared to non-taste tissue. Based on a digital photography the number of taste buds per subjects is counted manually.
15777608|NCT04633109|Diagnostic Test|anthropometry|Anthropometric data collection will include measures of body height, body weight, arm-, upper- and lower leg circumferences, waist- and hip circumferences and a bioimpedance analysis to obtain data about body composition.
15777609|NCT04633109|Other|biospecimen collection|Blood and saliva samples will be taken as well as a tongue swab.
15777610|NCT04633109|Other|questionnaires|Through the use of several questionnaires, data about eating behavior, food preferences, life style factors and other will be obtained.
15777611|NCT04633096|Behavioral|tailored feedback of depression screening results|The feedback for the participant contains the screening result, information about depression in general, guideline based treatment recommendations for patients and contact-information for treatment. The information is tailored to the participant's individual symptom profile, illness perceptions and preferences.
15777612|NCT04633096|Behavioral|standardized feedback of depression screening results|The feedback for the participant contains the screening result, information about depression in general, guideline based treatment recommendations for patients and contact-information for treatment.
15777613|NCT04633083|Other|Data collection|"Clinical Data: Registration of patient identity, sex and birth year, Body Mass Index, generic score EQ-5D-3L, Tampa Schaal voor kinesofobia and shoulder specific score like Constant Score, PROMS, ADLER, SST and postoperative ROM.
~Imaging Data: A preoperative and postoperative CT scan and 1-year postoperative radiograph (all three part of standard clinical practice) will be obtained. This data is used to extract the bone geometries and implant position.
~Movement Analysis: The subject should stand still followed by different motion tasks in the gait lab with collection of shoulder girdle kinematics and kinetics using a 14-camera VICON System.
~Stereo Radiographic EOS Measurements: Every subject included in the study will undergo a stereo radiographic EOS exam while quite standing with their arm in various positions (van Andel et al., 2008) .
~ROM simulation: With the developed ROM software, we will simulate the ROM of the 2 patient groups based on the available CT scan data."
15777614|NCT04633070|Behavioral|Gamification|Gamification (including, but not limited to a ranking system, badges and achievements, points, social media interaction, and leveling up) within mobile and web-based applications (also referred to as 'apps') for lifestyle modification (diet, physical activity, smoking cessation etc).
15777650|NCT04632875|Behavioral|Relaxation Meditation|Approximately 15-minute sessions are administered 6 days per week
15777651|NCT04632862|Drug|DWP16001|DWP16001 A mg
15777615|NCT04633057|Drug|TJ101|TJ101/ Recombinant Human Somatropin Injection treatment: after screening, subjects will be randomized to receive TJ101 1.2 mg/kg once a week until 52 weeks back site, investigator evaluate effectiveness and safety.
15777616|NCT04633057|Drug|NordiFlex|TJ101/ Recombinant Human Somatropin Injection treatment: after screening, subjects will be randomized to receive Recombinant Human Somatropin Injection 0.034 mg/kg once a day, until 52 weeks back site, investigator evaluate effectiveness and safety.
15777617|NCT04633044|Dietary Supplement|Betaine|The intervention with supplement will start during the first 48h after birth and will last for 12 weeks
15777618|NCT04633044|Dietary Supplement|Placebo|The intervention with supplement will start during the first 48h after birth and will last for 12 weeks
15777619|NCT04633031|Device|Boston|
15777620|NCT04633031|Device|Cheneau|
15777621|NCT04633018|Device|AsthmaMD mobile application|asthma management app with Spanish-language user interface
15777622|NCT04633018|Other|Usual care|Asthma management without the app
15777623|NCT04633005|Drug|Polypill|Polypill formulation consisting of metoprolol succinate, empagliflozin, and spironolactone.
15777624|NCT04633005|Drug|Control Rx|Typical prescriptions of guideline-directed therapies for heart failure with reduced ejection fraction.
15777637|NCT04632979|Procedure|Backwards running on a Treadmil with a negative slope|Running backward on a treadmill with a negative slope
15777638|NCT04632966|Biological|Biological: PTP-001|allogeneic placental tissue particulate
15777639|NCT04632953|Other|No Intervention|No Intervention
15777642|NCT04632927|Biological|Secukinumab|Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio
15777643|NCT04632927|Biological|Ustekinumab|Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio
15777644|NCT04632914|Other|trunk stabilizing exercise|trunk stabilizing exercise is a group of exercise which train the anterior thoracic cage and abdominal muscles in the form of static contraction of these muscles from a different position supine, sitting and standing.
15777645|NCT04632914|Other|cardiac rehabilitation programe|all patients continue this routine physiotherapy program for 40-60min.the patients incorporated into a variety of exercises conducted through arm ergometer,leg ergometer and treadmill.also the patients perform deep breathing exercise and coughing ececise
15777646|NCT04632901|Diagnostic Test|VA assessment|"The VA of all participants will be evaluated by counting the smallest line that can be read within a time duration greater than or equal to the average reading time of the larger lines minus 2.58 times the SD of the reading time of these lines.
~In clinical practice, the VA is the common parameter of VA adding a tolerant time limit to clearly determine the end of the test."
15777647|NCT04632901|Diagnostic Test|CVA assessment|"The CVA of all participants will be evaluated by counting the smallest line that can be read within a time duration greater than or equal to the average reading time of the larger lines minus 1.96 times the SD of the reading time of these lines.
~In clinical practice, the CVA is the minimum VA that can be read in maximal speed."
15777648|NCT04632888|Other|Telephone support for breastfeeding follow-up|The researcher, after the mother is discharged, by making a video call by phone every day for the first week, providing counseling to the mother on matters that she needs and recording it in the Baby Monitoring Form The researcher gives the mother a video
15777652|NCT04632849|Behavioral|GEM + CGM|Participants follow the GEM guidebook for 4 months (1 month of intervention and 3 months of maintenance) while wearing a FitBit activity monitor and a Freestyle Libre 2 CGM to provide feedback about activity and blood glucose. The GEM guidebook covers Routine choices, Recovering from blood glucose excursions, Reducing blood glucose excursions, and Maintenance.
15777653|NCT04632836|Other|quality of life questionnaires|responses for quality of life questionnaires (WHOQOL-BREF questionnaire, study specific questionnaire, PSQI index, HADS scale)
15777654|NCT04632823|Combination Product|Comprehensive Non-pharmacological Treatment Program|dietary supplement, specific type of exercise, self-management education
15777655|NCT04632810|Other|Ketogenic diet until reaching 10% weight loss|Participants will follow a low energy diet, with 1200 kcal per day. Carbohydrates 50g (17E%), protein 60 g (20E%), fat 84 g (63E%), until reaching 10% weight loss (approximately 10weeks).
15777656|NCT04632810|Other|non-ketogenic diet until reaching 10% weight loss|Participants will follow a low energy diet, with 1200 kcal per day. Carbohydrates 150g (50E%), protein 60 g (20E%), fat 40 g (30E%), until reaching 10% weight loss (approximately 10weeks).
15777657|NCT04632810|Other|Ketogenic eucaloric diet for weight stability|Participants will follow a low-calory-high-fat diet for 10 weeks. Carbohydrates10E%, protein 20E% and fat:70E%. Dietary plans will be based on individual measurement of energy needs by resting metabolic rate and physical activity level.
15777658|NCT04632797|Device|Hilotherm Chemo Care|Application of Hilotherm Chemo Care gloves for constant cryotherapy during chemotherapy application.
15777659|NCT04632784|Device|Artiflex Presbyopic implantation|Implantation of iris-fixated multifocal Artiflex Presbyopic IOL
15777660|NCT04632771|Other|N/A (observational study)|N/A (observational study)
15777661|NCT04632758|Drug|WX-0593 Tablets|tablets, 60 mg→180mg, QD
15777662|NCT04632758|Drug|crizotinib|Capsules, 250mg, BID
15777663|NCT04632745|Other|Wrist Rehabilitation|participants will undergo immobilization for the first 6 weeks of treatment
15777664|NCT04632732|Diagnostic Test|COVID-19 test|Nasal pharyngeal swab
15777665|NCT04632732|Diagnostic Test|Blood sampling|20cc of blood will be collected each 7 days during 28 days.
15777666|NCT04632719|Device|The use of the MentalPlus® digital game for assessment and rehabilitation of cognitive function after remission of the symptoms of COVID-19|Cognitive assessment and rehabilitation will be carried out on volunteers who have healed from COVID-19.
15777667|NCT04632706|Drug|Ivermectin|Investigation of the safety, tolerability and the pharmacokinetic profile of the Active IMP in an exploratory study
15777668|NCT04632706|Drug|Placebo|Matching Placebo to the Active IMP.
15777669|NCT04632693|Procedure|CAF with SCTG and Vitamin C injection|Injection of vitamin C after CAF with SCTG aiming to increase gingival thickness in patients with RT1 gingival recession.
15777670|NCT04632693|Procedure|CAF with SCTG alone|Coronally advanced flap with subepithelial connective tissue graft.
15777671|NCT04632680|Device|PVI followed by targeting of drivers|Patients will undergo intraprocedural ECG-I mapping. The pulmonary veins will be isolated followed by targeting of drivers aiming to terminate AF.
15777672|NCT04632667|Behavioral|Comparison School Group|All control schools will receive training and materials for the CATCH sun safety curriculum. Ray and the Sunbeatables®: A Sun Safety Curriculum is an evidence-based curriculum educates children, parents and teachers about sun protection and promotes sun safety behaviors in an effort to reduce children's lifetime risk of developing skin cancer. Training will be conducted with booster trainings yearly.
15777673|NCT04632667|Behavioral|Intervention School Group|"This intervention includes toothbrushing which will be implemented as a daily activity to develop skills and technique,classroom curriculum, which includes theory-based interactive lessons on oral health care,the physical education component consisting of an activity box containing different structured physical activities that will integrate the nutrition and oral health education messages, all cafeteria-based intervention materials including the tooth friendly Eat Smart guide, signage, nutrition labeling, menu planning and labeling using the tooth-friendly Go-Slow-Whoa CATCH terminology will be provided to the food service staff that is displayed across the cafeteria and sent home to parents and parents will be provided with tools and tips for maintaining oral health with website resources,parent-child homework activities, send-home infographics on dental care, parent-monitored tracking of child oral health,family fun nights in schools, and social media."
15777674|NCT04632654|Behavioral|A personalized Physical Activity intervention with fitness graded Motion Exergames (PAfitME)|A total of 7 weekly intervention sessions will occur in a period of 6 weeks. Week 0 is a setup session conducted at the participant's home, including equipment set up, safety instruction, personalized exergame prescription development, exergame physical activity practice, discussion of barriers and strategies, and Q&A session. Weeks 1 and 2 are coaching sessions delivered by the interventionist using the FaceTime application in iPad, including exergame minutes and prescription review, exergame physical activity practice, discussion of barriers and strategies, and Q&A session. Week 3 is a progress session conducted at the participant's home. The personalized exergame prescription will be adjusted. This session also will include exergame minutes review, exergame physical activity practice, discussion of barriers and strategies, and Q&A session. Weeks 4 and 5 are the same as weeks 1 and 2. Week 6 is the final session. Exergame platform will be picked up at the participant's home.
15777675|NCT04632641|Device|Perclose ProGlide Suture-Mediated Closure System (SMC) - SMALL-BORE PROCEDURES|The Perclose ProGlide Suture-Mediated Closure System (SMC) will be used to close the vein access site(s) at the completion of the small-bore procedure in order to achieve hemostasis.
15777676|NCT04632641|Other|Figure 8 Suture - SMALL-BORE PROCEDURES|A figure 8 suture will be done as a closure strategy in order to achieve hemostasis in small-bore procedures.
15777677|NCT04632641|Other|Manual compression - SMALL-BORE PROCEDURES|Manual compression will be done in order to achieve hemostasis in small-bore procedures..
15777678|NCT04632641|Device|Perclose ProGlide Suture-Mediated Closure System (SMC) - LARGE-BORE PROCEDURES|The Perclose ProGlide Suture-Mediated Closure System (SMC) will be used to close the vein access site(s) at the completion of the large-bore procedure in order to achieve hemostasis.
15777679|NCT04632641|Other|Figure 8 Suture - LARGE-BORE PROCEDURES|A figure 8 suture will be done as a closure strategy in order to achieve hemostasis in large-bore procedures.
15777763|NCT04631822|Procedure|Spinal anaesthesia|spinal anesthesia shall be conducted with 2.5 ml 0.5% hyperbaric bupivacaine at the L3/4 interspaces in the setting position.
15777680|NCT04632628|Behavioral|Web-based Cognitive Behavior Therapy for Insomnia (CBT-I)|Participants will complete 4 web-based CBT- I sessions. Lesson 1: Sleep Hygiene and Stimulus Control Lesson 2: Sleep Restriction and Relaxation Strategies Lesson 3: Identifying and Restructuring Dysfunction Thoughts Lesson 4: Practical Recommendations, Review, and Maintenance of Change
15777681|NCT04632602|Other|physiological effects of awake prone position in COVID 19 patients|"Study of physiological effects of awake prone position in COVID 19 patients on lung inhomogeneity assessed by Electrical Impedance Tomography (EIT), gas exchange and dyspnea score (Borg Scale).
~Measurements will be performed at baseline (on supine position), then patients will be randomized on the order of position, either supine then prone, either prone then supine. Each period will last at least 2 hours. EIT records will be performed during the last 30 minutes of each period, blood gas and dyspnea score at the end of each period."
15777682|NCT04632589|Drug|Losartan Potassium|subjects ingest 50mg losartan potassium tablet daily for 6 weeks
15777683|NCT04632589|Drug|Placebo|subjects ingest placebo tablet daily for 6 weeks
15777684|NCT04632576|Other|auricular acupuncture|Fine seeds will be attached on the surface of external ear and will be massaged intermittently.
15777685|NCT04632563|Other|Questionnaire including MSK-HQ (Musculoskeletal Health Questionnaire)|A questionnaire regarding musculoskeletal past medical history and current symptoms.
15777686|NCT04632550|Procedure|Circumferential pulmonary vein isolation(CPVI) group|"PVI(pulmonary vein isolation) will be performed using a radiofrequency catheter
~Esophageal temperature will be monitored to prevent esophageal injury.
~Evaluation of procedure time, radiofrequency ablation time
~Evaluation of the complication after the procedure.
~Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design."
15777687|NCT04632550|Procedure|Posterior box isolation(POBI) group|"PVI will be performed using a radiofrequency catheter
~Additional POBI(Posterior box isolation) is performed according to the traditional method and experience of the practitioner.
~Esophageal temperature will be monitored to prevent esophageal injury.
~The bidirectional block of each lesion set is the target of the procedures. But, we remain the incomplete block if three times of linear ablation failed to achieve the bidirectional block for the safety purpose.
~Evaluation of procedure time, radiofrequency ablation time
~Evaluation of the complication after the procedure.
~Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design."
15777688|NCT04632550|Procedure|POBI+Anterior linear ablation(AL) group|"PVI, POBI will be performed using a radiofrequency catheter
~Additional AL(anterior linear) ablation is performed according to the traditional method and experience of the practitioner.
~Esophageal temperature will be monitored to prevent esophageal injury.
~The bidirectional block of each lesion set is the target of the procedures. But, we remain the incomplete block if three times of linear ablation failed to achieve the bidirectional block for the safety purpose.
~Evaluation of procedure time, radiofrequency ablation time
~Evaluation of the complication after the procedure.
~Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design."
15777689|NCT04632537|Drug|Tice® BCG (for intravesical use) BCG LIVE strain of the BCG (Merck) vaccine|Tice® BCG (for intravesical use) BCG LIVE strain of the BCG (Merck) vaccine will be diluted in preservative-free saline and given intradermally (0.1mL) in the deltoid area.
15777690|NCT04632537|Drug|Preservative-free saline|Placebo will be administered in an intradermal route in the same location as the BCG vaccines: upper arm. Placebo will comprise 0.1 mL of the diluent (preservative-free saline) to ensure the same quantity and same color as the resuspended BCG vaccine, rendering the two indistinguishable.
15777691|NCT04632524|Drug|MgSO4|Group (M) n=30 will receive Mg So4 pre-induction as an intravenous bolus 20mg/kg over 10 minutes and maintenance dose intraoperative 5/mg/kg/h intravenous and discontinued just before the end of the surgery. Group (S) n=30 will receive saline in equal volume. The surgeon , anesthesiologist and the person who will collect the data will be blinded for the prepared solution. The solution will be prepared by an expert anesthesia nurse.
15777692|NCT04632511|Device|RECSAMP|Rectal Sampler
15777693|NCT04632498|Behavioral|Mindfulness Based Intervention|Standardized 8-week Cognitive and Behavioral Psychotherapy group with 26 hrs of in-class training and homework, along with 1 all-day retreat in which core mindfulness skills are developed
15777694|NCT04632485|Device|Ultrasound imaging|Carotid artery ultrasound exam. US imaging will include complete clinical carotid ultrasound examination (B-mode, Doppler and color-flow modes), clinical strain and shear wave imaging study, backscattered and beam-steered radiofrequency (RF) data acquisition using research mode, and reference phantom RF data acquisition.
15777695|NCT04632485|Device|Magnetic Resonance Imaging (MRI)|Head and Neck MRI exam with contrast
15777696|NCT04632472|Device|Active fixation bipolar lead versus passive fixation quadripolar leads in Cardiac Resynchronization Therapy|Cardiac resynchronization therapy trial comparing types of leads.
15777697|NCT04632459|Drug|pembrolizumab plus ramucirumab|"Patients will continue to receive study treatment, until they demonstrate objective disease progression (determined by modified RECIST 1.1) or until they meet any other discontinuation criteria.
~Ramucirumab 8mg/kg on q2W
~Pembrolizumab 200mg on q3W (pembrolizumab first followed by ramucirumab when concurrently administered on the same day)
~If ramucirumab had to be stopped due to intolerable toxicity, pembrolizumab will be continued until unacceptable toxicity, disease progression or upto 35 cycles."
15777698|NCT04632446|Other|Early diagnosis|Early diagnosis. Upgrade program implementation.
15777699|NCT04632433|Drug|Cemiplimab|350 mg every 3 weeks
15777700|NCT04632407|Dietary Supplement|"Flax milk"|See above
15777701|NCT04632407|Dietary Supplement|"Oat fibre milk"|See above
15777702|NCT04632394|Diagnostic Test|Generation of computational model from cardiac MRI.|Routine cardiac MRI scan results will be sent to Johns Hopkins University where a computer-generated model of the heart will be made, which will demonstrate predicted areas critical to VT generation and maintenance. This data will be sent back to St George's, and integrated with the standard VT ablation mapping software to allow comparison of its accuracy with standard mapping techniques.
15777703|NCT04632394|Procedure|VT ablation|Routine VT ablation as described elsewhere in the literature. However, a brief period of extra time (~30 minutes) will be spent analysing the areas of the heart which the MRI scan predicted as being important for generation of VT. We will study the effect of ablation of these areas (if indicated) on distant parts of the heart.
15777808|NCT04631510|Drug|Gabapentin 300 mg PO at 8 PM|Administer gabapentin 300 mg PO at 8 PM for sleep
15777706|NCT04632368|Behavioral|Transcendental Meditation|TM, a mind-body intervention that can reduce sympathetic arousal and promote a state of relaxation and calm, will be offered to HCPs dealing with COVID-19 pandemic
15777707|NCT04632355|Other|Interview|This interview will be conducted to collecting all outcomes about musculoskeletal pain in COVID-19 survivors
15777708|NCT04632342|Drug|HL301 tablet 300mg|"Experimental group 1 : 2 tablets at once, twice a day
~Experimental group 2 : 2 tablets at once, three times a day"
15777709|NCT04632342|Drug|Placebo of HL301 tablet|2 tablets at once, three times a day
15777710|NCT04632316|Drug|Cyclophosphamide-Fludarabine (Cy/Flu)|Lymphodepleting conditioning regimen
15777711|NCT04632316|Drug|oNKord®|Allogeneic ex vivo-generated Natural Killer (NK) cells from CD34+ umbilical cord blood progenitor cells
15777712|NCT04632303|Other|Early Palliative Care|Baseline palliative care visit Palliative care visits/calls at least every 4 weeks throughout life and additionally upon request Referral to exercise training Referral to nutritional specialist
15777713|NCT04632290|Device|STIMO-BSI system implantation|Participants are implanted bilaterally with epidural electrocorticography devices. The decoded motor intentions are driving the implanted spinal cord stimulation system. Brain-controlled spinal cord stimulation is used for training and rehabilitation to recover voluntary movements.
15777714|NCT04632277|Other|Water|Participants will receive a tab water
15777715|NCT04632277|Dietary Supplement|Water with low Mg|Participants will receive Low Mg bottle water (50mg/l)
15777716|NCT04632277|Dietary Supplement|Water with high Mg|Participants will receive High Mg bottle water (100mg/l)
15777721|NCT04632251|Device|SENSEI®|SENSEI® laparoscopic tethered gamma probe is an intra-operative laparoscopic gamma probe system
15777722|NCT04632238|Behavioral|Metrics-driven quality improvement (MDQI)|The intervention broadly consists of training and coaching to clinic staff and leadership on 1) clinical quality measure monitoring; 2) clinical practice process change management; and 3) use of tools for shared decision making and patient treatment progress monitoring.
15777723|NCT04632225|Biological|Engensis|Lyophilized biologic to be reconstituted containing Engensis
15777724|NCT04632225|Other|Placebo|Injectable liquid
15777725|NCT04632212|Behavioral|Explicit Tax|"To impose an explicit tax on food and beverage items that are eligible for red stop-sign food logos (explained in Intervention 2) as less healthy foods. Explicit tax shows pre-tax prices and a label indicating that the price includes a corresponding tax on the less healthy products.
~Food and Beverages: we will impose a 20% tax on sales price of the food items"
15777726|NCT04632212|Behavioral|Food Labels (with the summary of healthiness of shopping baskets & targets)|"To provide the green circle 'healthy choice' food label to items with Nutri-Score A and B, the amber circle 'in between healthy and unhealthy choice' food label to items with Nutri-Score C, and the red stop-sign 'less healthy choice' food label to items with Nutri-Score D and E.
~In the presence of food labels,
~Video: subjects will watch a video briefly explaining the food labels on the store.
~My Cart Summary: subjects will be provided a live visual indicator of the healthiness of shoppers' current basket with the recommended healthy baskets goals."
15777727|NCT04632212|Behavioral|Ordering|To order food items by Nutri-Score (high to low).
15777728|NCT04632212|Behavioral|Within-Group Substitution|To provide substitutes within corresponding food categories that are better than the items that subjects chose in terms of Nutri-Score based on the similarities of price, primary ingredients, flavor, and other characteristics.
15777729|NCT04632199|Drug|111In-IPN01087 Low dose|Administered once via slow intravenous injection.
15777730|NCT04632199|Drug|111In-IPN01087 High dose|Administered once via slow intravenous injection.
15777731|NCT04632186|Device|EXOPULSE Mollii suit|"All sessions start with rated perceived pain with the NRS and the ShoulderQ questionnaire and assessed body function with the Fugl-Meyer UE scale, Ashworth scale and the Neuroflexor, before the start of the intervention.
~Session 1. Stimulation with TENS according to best clinical practice. Session 2. Stimulation with the Mollii suit according to current best experienced practice with selective stimulation directed to the shoulder region Session 3. Stimulation using the full body Mollii suit according to current best experienced practice.
~Outcome of each session is assessed with a pain drawing, the NRS (during and after treatment) and the Fugl-Meyer UE, Ashworth scale and the Neuroflexor (after treatment)."
15777732|NCT04632173|Other|non interventional study|There is no intervention
15777733|NCT04632160|Device|IASD System II|The implant is placed across the interatrial septum using a percutaneous transcatheter approach.
15777734|NCT04632147|Other|Ujjayi pranayama, Nadi-Shodhana pranayama, Sukha pranayama|Ujjayi pranayama:It is a pranayamic application that is performed by slightly twisting the throat and breathing through the nose. Nadi shodhana pranayama is breathing alternately through the right and left nostrils.Sukha pranayama is inhaled through the nose for 5 seconds, then given through the nose for 5 seconds. Thus, 6 times of inspiration and expiration is done per minute.
15777809|NCT04631497|Diagnostic Test|test|"Beck's Test
~Test STAI
~Test PSS
~the scale of the fascination with death
~COPE"
15777810|NCT04631484|Drug|Cytoflavin ((Inosine + Nicotinamide + Riboflavin + Succinic Acid)|20 ml (2 ampoules, 10 ml each) dissolved in 200 ml of 0.9% sodium chloride, intravenously 2 times a day with an interval of 12 ± 2 hours, for 10 days.
15777973|NCT04630210|Drug|Atezolizumab|Atezolizumab 840 mg intravenous (IV) single-dose 14 days (+/- 4 days) before surgery
15777735|NCT04632134|Device|Transcutaneous vagal nerve stimulation (tVNS)|Transcutaneous vagal nerve stimulation (tVNS) will be performed using a noninvasive battery powered Transcutaneous Electrical Nerve Stimulation device (Nemos ©; Cerbomed, Germany). Electrical stimulation will be delivered by external electrodes through the skin surface at the conca of right external ear. Electrical current will be applied continuously with a pulse width of 200 μs and pulse frequency of 25 Hz. Stimulation amplitude will be adjusted between 0.1-6 mA, to a maximal amplitude level without causing patient discomfort.
15777736|NCT04632134|Other|Placebo|tVNS electrodes will be positioned in the right ear of the POTS patients without delivering stimulus (Sham)
15777737|NCT04632134|Device|Home daily transcutaneous vagal nerve stimulation|The home stimulation will consist of 4 hours of stimulation by the tVNS device organized as a 4 sessions of 1 hour. The home stimulation will last for 14 consecutive days.
15777738|NCT04632121|Drug|Nicorandil 20 MG|Nicorandil is a nicotinamide ester that dilates peripheral and coronary resistance vessels via action on ATP-sensitive potassium channels and possesses a nitrate moiety that promotes systemic venous and coronary vasodilation. As a result of these dual actions, nicorandil reduces preload and afterload and results in an increase in coronary blood flow. In addition to these effects, nicorandil may have cardioprotective actions mediated through the activation of potassium channel
15777739|NCT04632108|Drug|ASKB589 Injection|ASKB589 Injection with dose escalation stage of 0.3mg/kg up to10mg/kg,as well as dose expansion stage with recommended dose level from dose escalation stage.
15777740|NCT04632095|Procedure|Aortic valve replacement due to sternotomy|conventional surgery of aortic stenosis
15777741|NCT04632095|Procedure|Aortic valve replacement due to parasternal right anterior mini-thoracotomy|surgery of aortic stenosis in minimally invasive technique
15777742|NCT04632082|Behavioral|Telepsychoeducation with personalized videos|1 session with a psychologist plus 1 video a week for 4 weeks chosen based on symptom presentation
15777743|NCT04632082|Behavioral|Telepsychoeducation without personalized videos|1 session with a psychologist focused on reassurance and aspects of the outbreak
15777744|NCT04632069|Combination Product|N acetyl cysteine + vagus nerve stimulation|NAC x 14 days, taVNS x 10 days
15777745|NCT04632056|Drug|Beovu|There is no treatment allocation. Patients administered Beovu by prescription that have started before inclusion of the patient into the study will be enrolled.
15777746|NCT04632043|Other|Endotracheal intubation|Endotracheal intubation
15777747|NCT04632030|Behavioral|Tobacco power wall size and tobacco products displayed|The intervention varies the size of the tobacco power wall and number of tobacco products displayed on it.
15777748|NCT04632017|Diagnostic Test|Computerized cardiotocography|To compare Dawes and Redman indices as determined by computer analysis of the fetal heart tracing
15777749|NCT04632004|Other|Invitation to participate|Patients, visitors, and staff members of the University Medical Center Goettingen are invited to participate within our survey study. Study participation has no effect on any medical treatment.
15777750|NCT04631991|Diagnostic Test|Comprehensive ophthalmologic examination|Measurements of best-corrected visual acuity, refractive error, intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination, and optical coherence tomography angiography imaging.
15777751|NCT04631978|Diagnostic Test|Comprehensive ophthalmologic examination|Measurements of best-corrected visual acuity, refractive error, intraocular pressure, axial length, slit lamp examination of the anterior segment, dilated fundus examination, and optical coherence tomography angiography imaging.
15777752|NCT04631965|Behavioral|Transition support service|The hospital-wide transition support service provides systematic care coordination for young patients prior to the transfer of care
15777753|NCT04631952|Behavioral|Online exercise|SMS messeages on encouraging active lifestyle and online exercise video will be sent to the participant weekly for 8 weeks.
15777754|NCT04631952|Behavioral|SMS message|SMS messeages on encouraging active lifestyle will be sent to the participant weekly for 8 weeks.
15777755|NCT04631939|Device|Metacognitive training game|"In the fantasy world Macu'ta, players explore the world by walking around with an avatar in order to find the puzzles and proceed in the game. The intervention consists of 4 different puzzles. Unbeknownst to the player, the first pieces of evidence of each puzzle are often misleading, i.e. indicate the wrong solution, such that hasty decisions are punished. Players receive immediate feedback and are shown the correct response after submitting their solution, as well as explicit cues that educate them on the value of making adequately informed decisions. The order of the puzzles is fixed for each player, but different per session."
15777756|NCT04631939|Device|Control games|"In the fantasy world Macu'ta, players explore the world by walking around with an avatar in order to find the puzzles and proceed in the game. The control intervention consists of 4 different puzzle games requiring exclusively dexterity and accuracy (i.e., not including any metacognitive elements). The order of the puzzles is fixed for each player, but different per session."
15777757|NCT04631926|Behavioral|Hip Muscle Exercise|Standardized 12-week hip muscle exercises focusing on the external hip rotators with progressive resistance
15777758|NCT04631900|Behavioral|Christianity approach as framework for spiritual intervention|Intervention includes use of Bible verses, prayer, hymns singing, sharing and caring for others (mutual support) within the group. Through these activities, participants have opportunities to re-build and further develop their connectedness to themselves, to others, to their living, their environment, and to larger meaning and purpose.
15777759|NCT04631887|Behavioral|Doing What Matters in Times of Stress: An Illustrated Guide|"The Doing What Matters in Times of Stress: An Illustrated Guide is a booklet that is developed by World Health Organization. It is a stress management booklet formed to provide people skills for coping with stress and adversity. The booklet has accompanying audio exercises."
15777760|NCT04631874|Drug|CDFF0318, Champix|CDFF0318: Varenicline salt changed Champix: Varenicline tartrate
15777761|NCT04631848|Device|ULTRASCORE™ Focused Force PTA Balloon|The device will be used for percutaneous transluminal angioplasty (PTA) to dilatate calcified stenoses in below the knee vessels
15777762|NCT04631835|Drug|HS-10352|Participants will receive single dose of HS-10352 on Day 1 of Cycle 1 followed by once daily from Day 8 of Cycle 1. (Cycle length: 35 days for Cycle 1 and 28 days for all other cycles). Participants will continue treatment until the end of the study in the absence of unacceptable toxicities and unequivocal disease progression.
15777974|NCT04630197|Behavioral|e-CBT|The description is provided in the treatment arm description.
15777764|NCT04631822|Procedure|ultrasound-guided Adductor Canal Block + dexamethasone|"Ultrasound blocks will be done immediately after spinal anesthesia, before surgical intervention. A high-frequency linear ultrasound transducer was placed transverse to the longitudinal axis of the extremity at the midthigh level at a distance approximately halfway between the iliac spine and the patella. The femoral artery was identified underneath the sartorius muscle with the vein just underneath the artery. At this position, the saphenous nerve was placed lateral to the artery in the adductor canal (Fig. 1). A 10 cm Tuohy canula 18G Gauge (Braun Medical, Melsungen, Germany) was inserted, in plane, from the lateral side of the transducer, through the sartorius muscle with the tip placed lateral to the artery. then, a 20-ml mixture of 0.25% bupivacaine, and 4 mg dexamethasone will be injected."
15777765|NCT04631822|Procedure|ultrasound-guided Adductor Canal Block + dexmedetomedine|"Ultrasound blocks will be done immediately after spinal anesthesia, before surgical intervention. A high-frequency linear ultrasound transducer was placed transverse to the longitudinal axis of the extremity at the midthigh level at a distance approximately halfway between the iliac spine and the patella. The femoral artery was identified underneath the sartorius muscle with the vein just underneath the artery. At this position, the saphenous nerve was placed lateral to the artery in the adductor canal (Fig. 1). A 10 cm Tuohy canula 18G Gauge (Braun Medical, Melsungen, Germany) was inserted, in plane, from the lateral side of the transducer, through the sartorius muscle with the tip placed lateral to the artery.then, a 20-ml mixture of 0.25% bupivacaine, and 0.5 Mg/kg dexmedetomidine will be injected."
15777766|NCT04631809|Procedure|Coronary angiography +/- percutaneous coronary intervention|Comparison of performing invasive Coronary Angiography alone with performing CT-Coronary Angiography prior to the invasive Coronary Angiography
15777767|NCT04631809|Procedure|CT-Coronary Angiography + Coronary angiography +/- percutaneous coronary intervention|Comparison of performing invasive Coronary Angiography alone with performing CT-Coronary Angiography prior to the invasive Coronary Angiography
15777768|NCT04631796|Device|Lehfilcon A contact lenses|Silicone hydrogel contact lenses with investigational coating
15777769|NCT04631796|Device|Multipurpose disinfection solution|Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses
15777770|NCT04631770|Procedure|Systemic mediastinal lymph node dissection|Dissection of at least 3 groups of mediastinal lymph nodes, group 7 must be included.
15777771|NCT04631770|Procedure|No mediastinal lymph node dissection|Mediastinal lymph node is not dissection in this group.
15777772|NCT04631757|Drug|Camrelizumab + SOX + Radiotherapy|Camrelizumab 200mg,d1,Q3w; oxaliplatin 130mg/m2, d1, Q3w; S-1 40-60mg bid, d1-d14,Q3w; intensity modulated radiotherapy 45Gy/25d
15777773|NCT04631744|Drug|Cabozantinib|Subjects will receive cabozantinib orally at a (starting) dose of 40 mg once daily
15777774|NCT04631731|Diagnostic Test|Blood screening|Blood will be taken in order to screen for the unique patterns of non-coding/coding RNAs expression as well as immune checkpoints expression on CD4+/CD8+ T cells among patients with and without immune-related adverse events
15777775|NCT04631731|Diagnostic Test|Tissue screening|Tumour tissue will be obtained in order to screen for the unique patterns of non-coding/coding RNAs expression among patients with and without immune-related adverse events
15777781|NCT04631692|Behavioral|Health literacy intervention|"We will translate and adapt an intervention developed by Ferreira et al. to address health literacy and improve CRC screening. This intervention combined a 2-hour health literacy training targeting primary care physicians (which also included information about CRC screening) and a patient level intervention that consisted of a brochure and video.
~In order to promote generalizability, large-scale diffusion, dissemination and sustained use beyond the funded-research period, we will use blended learning to develop a 2-hour e-learning health literacy training in French and a one-hour booster session.
~The patient-facing intervention (video + brochure) will follow key plain language and health literacy principles to translate evidence-based information in content that all patients can understand. Existing materials developed in France will be used and adapted as relevant."
15777782|NCT04631666|Biological|DZIF-10c|SARS-CoV-2-neutralizing monoclonal antibody DZIF-10c by intravenous infusion
15777783|NCT04631666|Other|Placebo|Intravenous infusion of sterile normal saline (NaCl 0.9%) as placebo
15777784|NCT04631653|Device|VeriSee®|Screening of diabetic retinopathy using a validated deep learning-based software,VeriSee®
15777785|NCT04631627|Drug|Aspirin|With the result of risk assessment for high risk and the risk of pregnant women, with each research center stratified random aspirin drug intervention, for each center screening high-risk and accord with the standard drug intervention study phase into eliminate pregnant women by using stochastic indicator 1:1 randomly into low-dose aspirin to prevent group and observation group, for each center in screening for risk and comply with the drug intervention study phase into the exclusion standard 1:1 by random indicator method pregnant women randomly into low-dose aspirin to prevent group and observation group.
15777786|NCT04631614|Other|Warm up|Warm up through a walk or exercise bike for 5 minutes with moderate intensity according to modified Borg scale (CR-10)
15777787|NCT04631614|Other|Passive calf muscle stretching|With the participant lying in the supine position, the physiotherapist will passively perform the ankle dorsiflexion movement to stretch the participant's calf to the limit tolerated by the participant. This procedure will be performed in two repetitions with 30 seconds of held in the stretching position and 30 seconds of rest between repetitions.
15777811|NCT04631484|Drug|Placebo|20 ml of 0.9% sodium chloride (2 ampoules of 10 ml each), added to 200 ml of 0.9% sodium chloride, intravenously 2 times a day with an interval of 12 ± 2 hours, for 10 days
15778016|NCT04629924|Device|conventional technis|anesthesic injection with the conventional technic
15777788|NCT04631614|Other|Ankle joint mobilization - weight-bearing mobilization with movement (WB-MWM) technique|To perform the WB-MWM technique, the participant will be instructed to take a weight-bearing position with the tibia in a vertical position. The physiotherapist will be stay in front participant's ankle and will use the hands to stabilize the participant's foot as close as possible to the anterior region of the talus. A rigid belt will be placed on the participant's tibia and around physiotherapist´s hip. Then, the physiotherapist will project his hip backwards to produce a nonpainful anterior tibia glide. The participant will be asked to perform a forward lunge as far as possible without raising heel off the table and without reproducing knee symptoms. After achieving the maximum forward lunge, the participant will be instructed to hold this position for 5 seconds and then return to the starting position. This procedure will be performed in two sets of 10 repetitions with two minutes of rest between sets.
15777789|NCT04631614|Other|Clam exercise|The participant will side lying with trunk straight and both hips and knees at 45º and 90º of flexion, respectively. An elastic band will be used as external resistance, that will be positioned above the participant's knee. The individual will be instructed to perform the abduction and lateral rotation of the hip (keeping the heels in contact) against the resistance of the elastic band and then return to starting position. This exercise will be performed in three sets of 12 repetitions with on minutes of rest between sets. The exercise will be carried out with a load between 60-80% of the capacity and level of effort reported by the participant, according to the specifications of the modified Borg scale (CR-10). The load will be increased by 2-10% when the patient is able to perform 12 full repetitions in the last set of the exercise with perceived effort <60%.
15777790|NCT04631614|Other|Hip abduction exercise in side lying|The participant will side lying with trunk straight, both hips in a neutral position and both knee in extension. An elastic band will be used as external resistance, that will be positioned above the participant's knee. The individual will be instructed to perform the hip abduction against the resistance of the elastic band and then return to starting position. This exercise will be performed in three sets of 12 repetitions with with on minutes of rest between sets. The exercise will be carried out with a load between 60-80% of the capacity and level of effort reported by the participant, according to the specifications of the modified Borg scale (CR-10). The load will be increased by 2-10% when the patient is able to perform 12 full repetitions in the last set of the exercise with perceived effort <60%.
15777791|NCT04631614|Other|Knee extension exercise in a sitting position|The participant will be seated at the treatment table with the trunk straight and both knees in 90º of flexion. The external resistance will be positioned above the participant's ankle. The individual will be instructed to perform the knee extension at a protective angle (90º-45º of flexion), progressing to full extension (90º-0º of flexion) as long as the full knee extension does not reproduce the knee pain symptoms. Then, the participant will should return to starting position. This exercise will be performed in three sets of 12 repetitions with with on minutes of rest between sets. The exercise will be carried out with a load between 60-80% of the capacity and level of effort reported by the participant, according to the specifications of the modified Borg scale (CR-10). The load will be increased by 2-10% when the patient is able to perform 12 full repetitions in the last set of the exercise with perceived effort <60%.
15777792|NCT04631614|Other|Squat exercise|The participant will be stand with the trunk straight, knees in extension and feet hip-width apart. Dumbbells will be used as external resistance.The individual will be instructed to perform the squat movement at a protective angle (0º-45º of knee flexion), progressing to a deep squat (90º of knee flexion) as long as the movement does not reproduce the knee pain symptoms. Then, the participant will should return to starting position. This exercise will be performed in three sets of 12 repetitions with with on minutes of rest between sets. The exercise will be carried out with a load between 60-80% of the capacity and level of effort reported by the participant, according to the specifications of the modified Borg scale (CR-10). The load will be increased by 2-10% when the patient is able to perform 12 full repetitions in the last set of the exercise with perceived effort <60%.
15777793|NCT04631614|Other|Forward lunge exercise|The participant will be stand with one lower limb in a long stride forwards of the other limb, trunk straight and both knee in extension. Dumbbells will be used as external resistance. From this position, the participant will be instructed to bend both knees to lower your body at a protective angle (0º-45º of knee flexion), progressing to a greater knee flexion (90º) as long as the movement does not reproduce the knee pain symptoms. Then, the participant will should return to starting position. This exercise will be performed in three sets of 12 repetitions with with on minutes of rest between sets. The exercise will be carried out with a load between 60-80% of the capacity and level of effort reported by the participant, according to the specifications of the modified Borg scale (CR-10). The load will be increased by 2-10% when the patient is able to perform 12 full repetitions in the last set of the exercise with perceived effort <60%.
15777798|NCT04631588|Drug|Botox|Intradermal (ID) injection
15777799|NCT04631588|Drug|Placebo|Intradermal (ID) injection
15777800|NCT04631575|Drug|SHR6390|SHR6390, PO,single-dose
15777801|NCT04631562|Drug|ALXN1820 SC|ALXN1820 SC will be administered as a manual SC push or SC infusion via a syringe pump. Doses will range from 12.5 milligrams (mg) to a maximum of 2250 mg. Multiple dosing duration will range from 3 to 5 weeks.
15777802|NCT04631562|Drug|ALXN1820 IV|ALXN1820 IV (450 mg) will be administered as an IV infusion.
15777803|NCT04631562|Drug|Placebo SC|Placebo SC will be administered as a manual SC push or SC infusion via a syringe pump.
15777804|NCT04631562|Drug|Placebo IV|Placebo IV will be administered as an IV infusion.
15777805|NCT04631549|Drug|SHR3680|SHR3680, PO, single dose
15777806|NCT04631536|Drug|Atorvastatin + L-arginine + Folic acid + Nicorandil + Nebivolol|active Comparator: Endothelial dysfunction protocol + Standard of Care (dexamethasone, anticoagulation, vitamin c, zinc). Treatment to be continued until 14 days or discharge/death whichever occurs first. It includes: Nebivolol 5 mg PO daily, Sigmart 10 mg PO twice daily, Atorvastatin 40 mg PO daily, Folic Acid 5 mg PO daily, L-arginine 1000 mg PO 3 times daily.
15777807|NCT04631536|Drug|Placebo|Placebo + Standard of Care (dexamethasone, anticoagulation, vitamin c, zinc)
15777812|NCT04631471|Drug|Ibudilast|Increasing dose of ibudilast from 60mg/6 capsules per day to 100mg/10 capsules per day to be started up to 10 weeks prior to surgery. Treatment will continue up to 24 weeks after surgery. Maximum treatment period will be of 34 weeks.
15777813|NCT04631471|Procedure|Cervical decompressive surgery|Surgical decompression of degenerate cervical myelopathy
15777814|NCT04631471|Drug|Matching placebo|Increasing dose of matching placebo from 6 capsules per day to 10 capsules per day to be started up to 10 weeks prior to surgery. Treatment will continue up to 24 weeks after surgery. Maximum treatment period will be of 34 weeks.
15777815|NCT04631458|Other|standard of care.|Observational trial.
15777816|NCT04631445|Other|Ketogenic Diet|Ketogenic diet (KD) will consist of macros: dietary carbohydrates restricted to < 30 g/day; daily protein intake will be targeted to 1.5 g/kg/day (targeted to ideal body weight).
15777817|NCT04631432|Diagnostic Test|Pre-screening|Document upload of Autism diagnosis certificate. Participants can request to show their certificate via a Zoom meeting with the researcher instead of uploading it.
15777818|NCT04631432|Behavioral|Task session|"The Iowa Gambling task- four decks of cards on the computer screen. Each card yields a reward, but might also yield a loss. In each trial, the participant selects a card. Consequently, the card is exposed, displaying the gain and the loss for that trial. Through contingent feedback, participants are expected to learn that some deck are better than others.The task will include 120 trials.
~Block of trials without feedback- four decks of cards on the computer screen. Each card yields a reward, but might also yield a loss. In each trial, the participant selects a card. Consequently, the card is exposed, but the gain and the loss for that trial are not displayed. The task will include 30 trials.
~Social Responsiveness Scale, 2nd Edition (SRS-2; adult-self report):(Constantino & Gruber, 2012) The brief autism quotient scale:(AQ10; Baron-Cohen et al., 2001) Brief intelligence test (Similarities-MAB + Raven Set 1)"
15777819|NCT04631419|Other|Flapless laser corticotomy|The flapless laser corticotomy will be done by Er, Cr: YSGG laser as a series of circular holes will be made along with the planned position. The depth of laser cutting will be measured and controlled continuously during the operation by the periodontal probe with stopper read to each 3mm depth in addition to a few parts of a millimetre depth into the medullary bone to enhance bleeding. Canine retraction will be started after this procedure.
15777820|NCT04631419|Other|Canine retraction|canine retraction will be done on 17x25 stst archwire using coil spring adjusted to 150 gm, and miniscrews will be used as an indirect method of anchorage reinforcement
15777821|NCT04631406|Biological|Neural Stem Cells|NR1 is a human embryonic stem cell (hESC) derived product for the treatment of chronic ischemic subcortical stroke
15777823|NCT04631380|Other|PRAYER|THE PRAYER GROUP WILL RECEIVE ABSOLUTELY THE SAME CARE AS THE CONTROL GROUP PLUS PRAYERS
15777824|NCT04631367|Behavioral|Kukaa Salama: mHealth intervention|Kukaa Salama is a 8-week social group program of COVID-19 prevention messaging, which includes sending informational SMS once per week and holding secure group discussions on COVID-19 prevention. Weekly SMS messages will focus on COVID-19 knowledge, including information about transmission, hand washing, respiratory hygiene (coughing and sneezing in ways that won't spread germs), face masks, and physical distancing. Participants can also respond to the SMS with any questions about COVID-19, and the study team will respond with further information and/or additional resources. Weekly group chats will be administered using the customized WelTel platform, and will focus on discussions of how participants can apply and practice the information on COVID-19 prevention in their daily lives. Each group chat will be composed of 15-20 participants, and will be facilitated by a research assistant in Kampala as well as a peer navigator.
15777825|NCT04631367|Device|Face Mask + Soap|Participants will be offered the opportunity to pick up a parcel that contains a face mask, bar of soap, and a small parcel of food from the partner agency YARID.
15777826|NCT04631354|Drug|Radio-labelled S-770108|99mTc radio-labelled S-770108 supplied as a capsule containing 6 mg active pirfenidone for inhalation
15777827|NCT04631354|Device|S-770108 Inhaler A1|Dry powder inhaler
15777828|NCT04631341|Dietary Supplement|Melatonin|Melatonin 5mg every night, for one year
15777829|NCT04631328|Other|Growing Together|Growing Together is a suite of free, online research-informed professional development modules to help early childhood educators promote deeper family engagement and enrich teacher-parent interactions.
15777830|NCT04631315|Drug|Difluprednate Ophthalmic Emulsion 0.05%|1 drop, 2 times a day, starting the day before surgery and continuing for 14 post-surgical days and 1 drop, once a day for the next 2 weeks.
15777831|NCT04631315|Drug|Prednisolone Acetate 1% Phenylephrine hydrochloride 0,12% ophthalmic solution|1 drop, 4 times a day, starting the day before surgery and continuing for 14 post-surgical days and 1 drop, twice a day for the next 2 weeks.
15777832|NCT04631302|Behavioral|Be Mindful|"Be mindful is an online course run by the Mental Health Foundation and Wellmind Media. It was developed together with British mindfulness instructors and offers access to its course materials and instructional videos through a website (http://www.bemindfulonline.com).
~The course consists of 11 sessions led by two mindfulness teachers, one female, one male. Using a variety of media (videos, assignments, audio tracks and e-mails), participants are taught to use formal as well as informal mindfulness techniques. The course lasts 4 weeks. For each week, participants are asked to do a daily formal mediation practice (up to 30 minutes but it varies from week to week) and one or two informal exercises."
15777833|NCT04631302|Behavioral|Light exercise course|"The control condition involves light physical exercises aimed at increasing mobility, reducing stiffness, improving circulation, and avoiding pain or repetitive strain injuries that may result from sedentary or repetitive tasks common in office environments. The exercises will include simple whole-body slightly aerobic exercises such as rotation of limbs and stretching. The course was developed by Dr Julieta Galante, a public health doctor, together with an expert in body posture re-education and body techniques.
~The course is designed to match with the mindfulness intervention condition in duration and media (length of videos, amount of written instructions). It also replicates the encouraged use of short breaks (of seconds or minutes) throughout the workday to focus on wellbeing, as occurs in mindfulness."
15777834|NCT04631276|Drug|TS-091|Subjects received single-dose of 0.1, 0.2, 0.4, 1, 5, 12.5 and 25 mg of TS-091 (tablets or drug substance powder)
15777835|NCT04631263|Device|Hyaluronic Acid|Injectable gel. Chin correction and augmentation for retrusion
15777972|NCT04630210|Drug|Letrozole|Letrozole 2.5 mg/day oral until surgery
15777836|NCT04631250|Drug|5-Aminolevulinic Acid-Containing Product in Cutaneous Dose Form|5-Aminolevulinic Acid was applied to both sides of the face.
15777837|NCT04631237|Other|Observational, no intervention|No intervention involved
15777838|NCT04631211|Biological|Thrombosomes|Human platelet derived lyophilized hemostatic
15777839|NCT04631211|Biological|Liquid Stored Platelets (LSP)|Leukocyte reduced apheresis platelets or whole blood derived pooled platelet concentrate equivalent (4-6 units)
15777840|NCT04631198|Other|Thoracoabdominal rebalancing|the patients selected for the intervention group will be submitted to the handling of thoracoabdominal rebalancing as abdominal supports and / or in the ileo-costal space, inspiratory help, scapular waist release, thoracic swing, pectoralis major muscle release and deltoid together with aspiration if necessary.
15777841|NCT04631185|Drug|Single pre-operative dose of intravenous antibiotics with intraoperative redosing|Intravenous cefazolin, a cephalosporin antibiotic, will be prescribed to all patients before surgery. In case of allergy to cefazolin, intravenous clindamycin will be prescribed. For allergy to both antibiotics, an appropriate antibiotic should be chosen by the surgeon and documented. All patients will receive one dose of antibiotic within 60 minutes prior to incision, and any intraoperative doses of antibiotics according to current recommendations based on the antibiotic's dosing and on operative time.
15777842|NCT04631185|Drug|One week of post-operative antibiotics|The patients will be prescribed one week of Cephalosporin Antibiotic (Keflex/Duricef/Other) of their surgeon's choice.
15777843|NCT04631172|Other|Coronavirus Anxiety Scale , COVID-19 Phobia Scale|Using two questionnaire completed in face-to-face interviews Participants were asked the Coronavirus Anxiety Scale (CAS), and the COVID-19 Phobia Scale (C19P-S).
15777844|NCT04631159|Behavioral|Health2Sync app and report blood glucose data weekly|Patients will need to download and use the Health2Sync app and report blood glucose data weekly
15777845|NCT04631159|Other|self-manage|Patients will be asked to self-manage and there is no intervention during the tracking process
15777846|NCT04631146|Drug|Camrelizumab|PD-1 inhibitors
15777847|NCT04631133|Device|Lumbar Implant for Stiffness Augmentation (LISA)|The Lumbar Implant for Stiffness Augmentation (LISA) is intended to limit the lumbar lordotic movement thanks to a rigid spacer inserted between two adjacent spinous processes and to limit the kyphotic movement with an artificial ligament encircling the two adjacent spinous processes.
15777848|NCT04631120|Other|Integrated Dementia Practice Unit Design|"Dementia Central: monthly review of participant progress
~Dementia Mobile: monthly nurse/lay health educator visits for assessments, education and coaching
~Dementia Link: communication between Dementia Central and Dementia Mobile using the eTransX mHealth platform and HealthStream educational interface for care providers and the patient/caregiver dyad."
15777849|NCT04631120|Other|Standard of Care|Standard clinical practices of the physician and institution including an initial assessment, Zarit Burden Interview (ZBI) for caregiver, followed by provision of standard patient- and caregiver-centered educational material. Two phone sessions with a study nurse post-enrollment in months 1 and 6 to discuss the educational material and perform a needs assessment.
15777850|NCT04631107|Drug|AD109 dose1|Oral administration at bedtime
15777851|NCT04631107|Drug|AD109 dose2|Oral administration at bedtime
15777852|NCT04631107|Drug|Placebo|Oral administration at bedtime
15777853|NCT04631094|Other|The group holding the serrated ball in the hand on the extremity from which venous blood will be taken|Children in the experimental groups will squeeze the serrated ball during the blood draw.
15777854|NCT04631094|Other|The group holding the serrated ball in the hand on the opposite side of the extremity from which venous blood will be taken.|Children in the experimental groups will squeeze the serrated ball during the blood draw.
15777855|NCT04631094|Other|The group holding a smooth ball in the hand on the extremity from which venous blood will be taken|Children in the experimental groups will squeeze the smooth ball during the blood draw.
15777856|NCT04631094|Other|The group holding a smooth ball in the hand opposite the extremity from which venous blood will be taken.|Children in the experimental groups will squeeze the smooth ball during the blood draw.
15777857|NCT04631081|Procedure|coverage of the fingertips with bipedicled palmar island flap|The initial step is wound debridement. To design the flap, a longitudinal line is drawn at the junction of the volar and dorsal parts of the finger, starting from the distal part of the proximal interphalangeal joint flexion crease. It will be harvested from distal to proximal dissecting the digital canal plane. By releasing the Cleland and Grayson ligaments, the neurovascular bundle will be dissected. On the intermediate phalange, the dorsal branch of the neurovascular bundle must be preserved to maintain blood flow to the dorsal skin. Dissection is completed at the junction between the palmo-dorsal arteries and the collateral neurovascular bundles on both sides of the finger. A triangle may be resected at the distal edge of the flap to reshape of the pulp. Bone may be resected if needed to allow tension-free closure of the distal part of the flap. No Immobilization will be necessary.
15777858|NCT04631081|Other|occlusive dressing|patients will be evaluated on admission and benefit from wound irrigation, debridement and placement of a simple dressing with Adaptic or Jelonet, either in the Emergency department or in the Hand Surgery department. At 48 hours, they will be addressed to the Hand Surgery department to place a self-adhesive polyurethane film. Follow-up will include a visit at 1 week for dressing change, and then weekly for further dressing change until healing. Skin proximal to the injury will be degreased to increase adherence of the dressing. Distally, the film leaves a pocket to collect wound exudate. During treatment, the foul-smelling liquid produced by the wound and clots collected in the occlusive dressing will not be removed. A gauze covers the occlusive dressing to protect the liquid pocket and cover potential smell.
15777859|NCT04631068|Procedure|Cataract surgery|Small incision cataract surgery with implantation of an intraocular lens
15777860|NCT04631055|Device|drug coated balloon|paclitaxel coated balloon catheter for intracranial PTA treatment
15777861|NCT04631055|Device|stent system|The Intracranial Stent System comprises of a balloon expandable stent and a delivery catheter that features a rapid exchange catheter design with a semi-compliant balloon located at its distal end.The product, APOLLO™ stent system, has the indication of endovascular treatment for intracranial stenosis approved by NMPA.
15777862|NCT04631029|Biological|Atezolizumab|Given IV
15777863|NCT04631029|Drug|Carboplatin|Given IV
15777864|NCT04631029|Drug|Entinostat|Given PO
15777865|NCT04631029|Drug|Etoposide|Given IV
15777868|NCT04631003|Diagnostic Test|dynamic functional testing|First, with an arthroCT of the wrist by intraarticular injection of contrast agent, a possible scaphulonary band lesion is detected. The surgeon does not yet know the findings of the possible ligament injury at this time, but he can assess the fracture in the CT. Subsequently, a dynamic functional test of the scapholunary distance is carried out intraoperatively under investigation with the modified Watson test before and after performing the osteosynthesis. For this purpose, the wrist is intraoperatively brought under pull on the thumb from a radial abduction into an ulnarabduction. In the presence of a scapholunary instability, a change in the distance of the scapholunary joint gap is shown here under illumination. Now the surgeon receives the finding of the Arthro-CT regarding an existing ligament injury. If necessary, this is treated in the same anaesthetic with a band seam and ossary transfixation.
15777869|NCT04630977|Dietary Supplement|Multi-ingredient Pre-workout supplement|Every important issue has been detailed before.
15777870|NCT04630977|Other|Progressive Resistance Training|The information about it has been detailed in advance.
15777871|NCT04630977|Behavioral|Nutritional Patterns Guideline|This intervention has also been described in advance.
15777872|NCT04630964|Drug|Psilocybin|psilocybin 25 mg Single Oral Dose
15777873|NCT04630964|Drug|Niacin|niacin 100mg Single Oral Dose
15777874|NCT04630951|Other|Blood Flow Restriction Strength training with low load|Low Load (20-50% 1RM), 4 set of 30/15/15/15 repetitions, 30 seconds resting between sets.
15777875|NCT04630951|Other|High Load Strength Training|High Load (60-80% 1RM) 4 sets of 8 repetitions, 2 minutes resting between sets
15777876|NCT04630938|Drug|Morphine Sulfate|intrathecal morphine will be added to anaesthetics
15777877|NCT04630938|Drug|morphine+lidocaine|local anesthetic will be infused intravenously
15777878|NCT04630938|Drug|Saline|intravenous saline infusion
15777880|NCT04630912|Other|Acceptance and Commitment Therapy|There is no specific protocol for ACT with dementia, therefore a published ACT protocol, 'Better Living with Illness' (Brassington et al., 2016), will be used flexibly to guide the intervention.
15777881|NCT04630899|Other|Active joint mobilization|The participants bend his knees in a prone position. The physical therapist holds the medial malleolus with one hand and the lateral malleolus with the other. At the same time, the physical therapist touches the participant's soles to the sternum area and presses them in the dorsal direction. At this time, medial malleolus glides anterior and lateral malleolus glides posterior. The first procedure is to passively recognize movement. The second procedure is accompanied by active movement of the participant.
15777882|NCT04630899|Other|Passive joint mobilization|PJM uses Maitland's Mobilization method, grade III (high amplitude in the end range of the joint and 1 second vibration in the middle range through linear motion in which tissue resistance is felt). The participant is in a supine position, and the physical therapist holds the talus with one hand and the tibia with the other hand, and performs joint mobilization in the posterior direction with the hand holding the talus.
15777883|NCT04630886|Drug|Tranexamic acid injection|subcutaneous injection of 50mg/ml TXA
15777884|NCT04630886|Drug|Lidocaine Epinephrine|subcutaneous injection of 1% lidocaine mixed with 1:200,000 epinephrine
15777885|NCT04630873|Drug|Botulinum toxin|The triceps surae along with the posterior tibialis muscle will be injected. The units that will be injected are the average being injected in our University Clinic. I.e. 50 units for each head of the gastrocnemius muscle- single injection site, 100 units for the soleus muscle- two injection sites and 50 units for the posterior tibialis muscle- single injection site.
15777886|NCT04630873|Diagnostic Test|gait analysis|The gait analysis will be performed with two systems. A foot pressure sensitivity walkway (medicapteurs Win-Track), and an IMU network system (RehaGait Pro) using seven IMU's placed in specific anatomical positions. In combination those two systems can provide a wide range of spatiotemporal analytics of gait:
15777887|NCT04630860|Drug|LY03003|Rotigotine,extended-release microspheres
15777888|NCT04630847|Biological|Fecal Microbiota Transplant|FMT utilizing stool from first degree relatives
15777889|NCT04630834|Drug|Ibuprofen|Patients will receive both ibuprofen 10mg/kg weight based dosing with a max of 600mg
15777890|NCT04630834|Drug|Acetaminophen|patients will receive acetaminophen 15 mg/kg weight based dosing with a max of 650mg
15777891|NCT04630834|Drug|Placebo|patients will receive placebo 15mg/kg weight based dosing with a max of 650mg
15777892|NCT04630821|Other|Dilute Sodium Hypochlorite solution|"Subjects will be treated with the dilute bleach compresses daily for the first 3 weeks of therapy.
~While these subjects are undergoing radiation therapy, they will be assessed weekly before the day's compress treatment by a physician investigator on the study team. Subjects will be evaluated and photographs will also be taken at study visits 1-3. The subjects will also complete a subject questionnaire addressing patient-reported outcomes at baseline and each weekly check-in during these two weeks. They will be also interviewed about ease of use and treatment tolerability. Subjects will complete interview questions at the end of the study to determine if they would continue the treatment and any obstacles or barriers."
15777893|NCT04630808|Drug|NCX 470 0.1%|NCX 470 Ophthalmic Solution, 0.1%
15777894|NCT04630808|Drug|Latanoprost 0.005%|Latanoprost Ophthalmic Solution, 0.005%
15777895|NCT04630795|Device|ViscoTurf insole|Intervention insole will be produced as 3D printed insole with the Turf-Like patches incorporated in the areas of interest.
15777896|NCT04630795|Device|Control insole|Control Insole will be a standard 3D printed flat insole with NO Turf-like patches.
15777897|NCT04630782|Diagnostic Test|PET-MRI scan|Participants will be scanned centrally at Clinical Imaging Research Centre (CIRC, Singapore), on a Biograph mMR PET-MR scanner. Combined FDG-PET-MRI scan is critical for co-registration of peristaltic bowel for optimal image quality. The oesophagus to anorectum will be imaged. The PET-MRI scan starts 60 minutes post-FDG injection of 6mCi and immediately after injecting 10mg hyoscine butylbromide to reduce peristalsis. MRI sequences are non-contrast.
15777898|NCT04630769|Drug|IP FT516|FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation
15777899|NCT04630769|Drug|Enoblituzumab|Enoblituzumab is an Fc-optimized monoclonal antibody that targets B7-H3 which is highly expressed on ovarian cancer. Enoblituzumab at 15 mg/kg IV, one day before lymphodepleting chemotherapy
15777900|NCT04630769|Drug|IL-2|IL-2 at 6 Million IU (3 Million IU/m2 if patient weight is <45 kg) is administered IP in 50 cc of room temperature D5W via peritoneal catheter directly after the FT-516 infusion is completed. Immediately following the IL-2, an additional 100 cc D5W flush is infused into the peritoneal cavity through the peritoneal catheter as rapidly as possible.
15777901|NCT04630756|Drug|AZD4573|AZD4573 will be administered as an absolute (flat) dose, 2-hour (± 15 minutes) IV infusion once weekly in combination with orally administered acalabrutinib twice daily continuously. For both Part A and Part B of this study, Cycle 1 consists of 5 weeks, with a dose ramp-up. Subsequent cycles are 21 days (3 weeks) with once weekly dosing of AZD4573 in combination with acalabrutinib twice daily continuously.
15777902|NCT04630756|Drug|Acalabrutinib|Oral Acalabrutinib capsule will be administered twice daily continuously from Day 1 of Cycle 1 Week 1 in combination with AZD4573.
15777903|NCT04630743|Behavioral|Cognitive and Behavioral intervention for the Management of Episodic Breathlessness|The cognitive and behavioral brief intervention comprises two parts: In a first module, the intervention and the study team is introduced, the definition of episodic breathlessness is given and the individual characteristics of breathlessness episodes are recorded. Goals of the intervention are discussed. In a subsequent module on patient education and the strategies, the patient and intervention executor discuss the patients' assumptions about episodic breathlessness including triggers and already used management strategies for breathlessness episodes. This follows the presentation of the non-pharmacological strategies: movement of air/ handheld fan, forward lean, diaphragmatic breathing, distraction, pursed lips breathing, long breaths out and relaxation training. The patient selects 2-3 strategies and trains them with the intervention executor.
15777904|NCT04630730|Drug|Recombinant intravesical BCG (Bacillus Calmette-Guérin VPM1002BC)|1 dose of VPM1002BC, live, 1-19.2 x 108 colony forming units (CFU) on day 1, 8 and 15
15777905|NCT04630730|Drug|Atezolizumab|Neoadjuvant immunotherapy with atezolizumab, 4 cycles 1200 mg fixed dose iv infusion on d1 q3w starting 4-16 weeks after date of surgery
15777906|NCT04630730|Drug|Cisplatin|Neoadjuvant chemotherapy with cisplatin: 4 cycles 70mg/m2 iv infusion on d1 q3w (starting on d22)
15777907|NCT04630730|Drug|Gemcitabine|Neoadjuvant chemotherapy with gemcitabine: 4 cycles 1000 mg/m2 iv infusion on d1 and d8 q3w (starting on d22)
15777908|NCT04630717|Other|Medical hypnosis session|"the therapist will use a standard and identical protocol in all patients: the International characteristics of the hypnosis protocol are the following hypnotic induction through conversational hypnosis and interviewing about leisure activity.
~A catalepsy of the hand or the finger will be done, also to stabilize hypnosis if it is accepted by the patient"
15777909|NCT04630717|Other|control groupe|the therapist will use usual voice,loud and strong voice,. clear, high position of the doctor, medical speech focused,no question about the patient's privacy will be made.
15777910|NCT04630704|Device|Pedra|Diffuse speckle contrast analysis perfusion system
15777911|NCT04630691|Procedure|Implantation|Patients received narrow diameter implants in posterior mandible or maxilla
15777912|NCT04630678|Other|Virtual Reality Therapy|Virtual reality games were applied to participants for 30 minutes.
15777913|NCT04630678|Other|Conventional Physiotherapy|Joint and muscle mobilization, strengthening, and stretching exercises by neurodevelopmental treatment principles were applied to participants for 30 minutes.
15777914|NCT04630678|Other|Activity Training|Unilateral, bilateral, and bimanual activity training that supported manual skills for 30 minutes.
15777915|NCT04630665|Other|immediate implant placement|immediate implant placement in thin and thick buccal bony plates
15777916|NCT04630652|Drug|Risankizumab-Rzaa|Risankizumab at a dose of 150 mg with injections administered at baseline, week 4 and week 16 following FDA-approved dosage and time periods
15777917|NCT04630652|Procedure|Punch biopsies of the skin at baseline visit|Two 6 mm punch biopsies of the skin at baseline visit
15777918|NCT04630652|Procedure|Punch biopsies of the skin at week 28 visit|One 6 mm punch biopsy of the skin at week 28 visit
15777919|NCT04630639|Device|Sparkle|The Sparkle device is a single-use device intended to aid the diagnosis of sleep-disordered breathing; however, this study is intended only to validate the respiratory effort signal and does not assess diagnostic performance.
15777920|NCT04630626|Device|Simplify Disc|The Simplify Disc is a cervical artificial disc manufactured from polyether ether ketone (PEEK) endplates and a mobile, zirconia-toughened alumina ceramic core.
15777921|NCT04630600|Other|No intervention|Normal waiting room without an aquarium
15777922|NCT04630600|Other|Partially-equipped aquarium in the waiting area|Waiting room with a partially-equipped Aquarium
15777923|NCT04630600|Other|Fully-equipped aquarium in the waiting area|Waiting room with a fully-equipped Aquarium
15777924|NCT04630587|Procedure|Indirect restorations|see the Arm description
15777925|NCT04630574|Other|Speech evaluation with the clinical evaluation of dysarthria|A first speech evaluation with the clinical evaluation of dysarthria during 30 minutes is proposed to exclude very severe dysarthria.
15777926|NCT04630574|Other|complete assessment of the MonPaGe computerized protocol|The application records directly and anonymously stores speech productions made by the patient.
15777927|NCT04630561|Behavioral|Postural Intervention Program|Dynamic warmup program designed to target several areas of physical and mental wellbeing.
15777928|NCT04630548|Device|Intrauterine copper device|The obstetrical team will identify subjects who present in labor who meet the criteria and express interest in intrauterine contraception. Immediately after cesarean delivery, consented subjects will be randomized to immediate post placental IUD placement within 10 minutes or IUD placement at their routine standard postpartum visit (6 to 8 weeks postpartum).
15777929|NCT04630535|Procedure|aorto-bifemoral bypass surgery|aorto-bifemoral bypass surgery (Leriche syndrom, elective AAA repair)
15777930|NCT04630522|Drug|Drug: JMT103- 120 mg SC Q4W|JMT103 is administered subcutaneously at a dose of 120 mg on day 1 of each 4-week cycle.
15777931|NCT04630522|Drug|Drug: JMT103- 120 mg SC Q8W|JMT103 is administered subcutaneously at a dose of 120 mg on day 1 of each 8-week cycle.
15777932|NCT04630522|Drug|Drug: JMT103- 180 mg SC Q8W|JMT103 is administered subcutaneously at a dose of 180 mg on day 1 of each 8-week cycle.
15777933|NCT04630522|Dietary Supplement|Dietary Supplement: Calcium Dietary Supplement: Vitamin D|Calcium is given orally at a dose of 500 mg at least, once daily. Vitamin D is given orally at a dose of 400 IU at least, once daily.
15777934|NCT04630509|Procedure|traumatic cataract extraction|Irrigation/aspiration of traumatic cataract in children with posterior chamber intraocular lens implantation
15777935|NCT04630496|Behavioral|Fitbit|Electronic activity tracker
15777936|NCT04630483|Other|INHA|NLR and PLR ratio will be assessed at postoperative 6th and 24th hours compared to preoperative values
15777937|NCT04630483|Other|TIVA|NLR and PLR ratio will be assessed at postoperative 6th and 24th hours compared to preoperative values
15777938|NCT04630470|Behavioral|massage therapy with lavender oil|massage therapy with lavender oil-on both lower leg areas, for 10 minutes on each leg, for 4 weeks, three times a week, in the HD sessions
15777939|NCT04630470|Behavioral|massage therapy with baby oil|massage therapy with baby oil-on both lower leg areas, for 10 minutes on each leg, for 4 weeks, three times a week, in the HD sessions
15777940|NCT04630457|Device|Conventional ankle prosthesis|At the first visit, 3D motion analysis, dynamic EMG analysis, energy consumption analysis, 6 minute walk test, Berg balance scale, Locomotor Capabilities Index, and Korean-Prosthesis Evaluation Questionnaire will be evaluated using the conventional prosthesis that the patient had.
15777941|NCT04630457|Device|Meridium® (Microprocessor ankle prosthesis)|There are two weeks apart between each visit. Depending on the group to which the patient belongs, at the second or third visit, 3D motion analysis, dynamic EMG analysis, energy consumption analysis, 6 minute walk test, Berg balance scale, Locomotor Capabilities Index, and Korean-Prosthesis Evaluation Questionnaire will be evaluated using Meridium®. For example, if visit 2 was evaluated using Meridium®, visit 3 was evaluated using RoFT®. In another example, visit 2 is evaluated using RoFT®, while Visit 3 is evaluated using Meridium®.
15777942|NCT04630457|Device|RoFT® (Microprocessor ankle prosthesis)|There are two weeks apart between each visit. Depending on the group to which the patient belongs, at the second or third visit, 3D motion analysis, dynamic EMG analysis, energy consumption analysis, 6 minute walk test, Berg balance scale, Locomotor Capabilities Index, and Korean-Prosthesis Evaluation Questionnaire will be evaluated using RoFT®. For example, if visit 2 was evaluated using RoFT®, visit 3 was evaluated using Meridium®. In another example, visit 2 is evaluated using Meridium®, while Visit 3 is evaluated using RoFT®.
15777943|NCT04630444|Drug|Riluzole|30 PTSD patients with riluzole 100 mg daily (50 mg bid).
15777944|NCT04630431|Other|Electronic Health Record Review|Review of medical record
15777945|NCT04630431|Other|Questionnaire Administration|Complete questionnaire
15777946|NCT04630418|Other|NanoSilk Cosmo|Participant will receive 30 mL of NanoSilk Cosmo jar.
15777947|NCT04630405|Device|Wright jet nebulizer|Roxon Medi-Tech, Montreal, QC, Canada
15777948|NCT04630405|Device|Aerogen Solo|Aerogen Ltd., Galway, Ireland
15777949|NCT04630392|Other|Treadmill Training|Ten minutes of treadmill walking at 110% self-selected overground walking speed
15777950|NCT04630392|Other|Whole Body Vibration & Treadmill Training|Eight bouts of 90 seconds of vibration at 20 Hz and an amplitude of 2 mm on a Galileo Med-L side-to-side-alternating WBV plate (StimDesigns LLC, Carmel, CA, USA) followed by ten minutes of treadmill walking at 110% self selected overground walking speed.
15777951|NCT04630379|Other|Palliative Therapy|Visit with palliative care team
15777952|NCT04630379|Other|Quality-of-Life Assessment|Ancillary studies
15777953|NCT04630379|Other|Supportive Care|Visit with neuro-oncologist
15777954|NCT04630379|Other|Survey Administration|Complete survey
15777955|NCT04630366|Drug|NST-1024|NST-1024
15777956|NCT04630366|Drug|Placebo|Matching placebo to NST-1024
15777957|NCT04630353|Drug|HB-201 IT|Cohort 1: HB-201 given IT, one (1) time, on day 1.
15777958|NCT04630353|Drug|HB-201 IV|Cohort 2: HB-201 given IV, one (1) time, on day 1.
15777959|NCT04630353|Drug|HB-201 IT|HB-201 will be administered IT, one (1) time, 7 to 14 days prior to definitive chemoradiation.
15777960|NCT04630340|Device|STEADES-2|In this arm, the subjects will use a novel exhaled breath carbon monoxide measurement instrument (STEADES-2) for self surveillance of their smoking status. In addition, the subjects will download the STEADES-2 mobile phone application to pay serious games relating to smoking cessation, receive push-though motivational messages and e-coaching from trained healthcare professionals.
15777961|NCT04630327|Other|Beck Depression Inventory-21 (diagnostic survey)|Kazakh or Russian versions of the Beck Depression Inventory-21will be filled by breast cancer patients
15777962|NCT04630327|Other|Beck Anxiety Inventory|Kazakh or Russian versions of the Beck Anxiety Inventory will be filled by breast cancer patients
15777963|NCT04630327|Other|Interview using The Diagnostic and Statistical Manual of Mental Disorders-V (DSM - V)|Interview using The Diagnostic and Statistical Manual of Mental Disorders-V (DSM - V) criteria as a gold standard of diagnosing depression or anxiety
15777964|NCT04630314|Device|Percutaneus Coronary Intervention|Covered Stent
15777965|NCT04630288|Drug|Clopidogrel|Describe the safety of Ticagrelor vs Clopidogrel use, in patients with ACS in terms of major bleeding between 30 days and one year after the index ACS event. An ITT approach and IPCW method to adjust for change of initial treatment will be used for the analysis.
15777966|NCT04630288|Drug|Ticagrelor|Describe the safety of Ticagrelor vs Clopidogrel use, in patients with ACS in terms of major bleeding between 30 days and one year after the index ACS event. An ITT approach and IPCW method to adjust for change of initial treatment will be used for the analysis.
15777967|NCT04630262|Device|ATTUNE Cementless CR Fixed Bearing|Subjects Implanted with the ATTUNE Cementless Femoral, Cementless Tibia, and CR Tibial Insert.
15777968|NCT04630262|Device|ATTUNE Cementless PS Fixed Bearing|Subjects Implanted with the ATTUNE Cementless Femoral, Cementless Tibia, and PS Tibial Insert.
15777969|NCT04630249|Behavioral|Listening to Women|Participants are enrolled in message-based screenings with immediate automated feedback, paired with remote care coordination and, if appropriate, home-based telemedicine mental health and substance use disorder treatment services.
15777970|NCT04630236|Diagnostic Test|Ultrasound|Using ultrasound control, the central vein catheter is injected with saline solution and the time to detect the saline bolus in the ultrasound is measured.
15777971|NCT04630223|Diagnostic Test|endocan in umbilical cord blood|After taking blood samples from the umbilical cord, centrifugation is applied to all samples for 15 minutes at 1000 rpm. The serum samples with specific identification numbers are going to be stored at -80 °C. After completing the study group, all serum samples will be analyzed using human endocan ELISA kit for the measurement of endocan levels.
15777975|NCT04630184|Behavioral|Exposure intervention in virtual reality|6 sessions of 45 minutes weekly and 2 follow-up meetings (3 and 6 weeks after the weekly follow-up) with cognitive restructuring and VR exposure supervised by psychologists
15777976|NCT04630184|Behavioral|Exercise|Participants will have to go twice a week, for 12 weeks to carry out 2 individual endurance training sessions of 45 minutes (moderate to vigorous intensity), supervised by a kinesiologist. Participants will also have to complete a 3rd 60-minute endurance session at home (or two 30-minute sessions).
15777977|NCT04630184|Behavioral|Placebo|6 sessions of 45 minutes weekly and 2 follow-up meetings (3 and 6 weeks after the weekly follow-up) Discussion around social physical anxiety, stress management (relaxation and breathing) supervised by psychologists
15777978|NCT04630171|Device|Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure|Group #1: VerTouch utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia
15777979|NCT04630171|Device|Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure|Group #2: Ultrasound (US) utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia
15777980|NCT04630171|Other|Group #3: Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure|Control group, palpation utilized for identification of site for labor epidural or spinal anesthesia procedure for women requesting labor analgesia
15777981|NCT04630171|Device|Group #4: VerTouch utilized for identification of site for lumbar puncture procedure|Group #4: VerTouch utilized for identification of site for lumbar puncture procedure for patients undergoing a therapeutic lumbar puncture
15777982|NCT04630171|Device|Group #5: Ultrasound (US) utilized for identification of site for lumbar puncture procedure|Ultrasound (US) utilized for identification of site for lumbar puncture procedure for patients undergoing a therapeutic lumbar puncture
15777983|NCT04630171|Other|Group #6: Control group, palpation utilized for identification of site for lumbar puncture procedure|Group #6: Control group, palpation utilized for identification of site for lumbar puncture procedure for patients undergoing a therapeutic lumbar puncture
15777984|NCT04630158|Other|SAF312 Placebo|Topical ocular, suspension eye drops,
15777985|NCT04630158|Drug|SAF312|Topical ocular, suspension eye drops
15777986|NCT04630145|Drug|Bedaquiline|Participants will receive BDQ tablets only/
15777987|NCT04630145|Drug|Clarithromycin|Participants will receive CAM 400 mg twice a day.
15777988|NCT04630145|Drug|Ethambutol|Participants will receive 500 to 750 mg daily (maximum daily dose of 1.0 gram [g]) daily.
15777989|NCT04630145|Drug|Rifampicin|Participants will receive daily dose is 450 mg (maximum 600 mg) RFP capsule once a day.
15777990|NCT04630145|Drug|Rifabutin|Participants will receive daily dose of RBT 300 mg capsules once a day.
15777991|NCT04630119|Other|Questionnaires on quality of life, emotional health and presenteeism|After obtaining informed consent, a pro forma consisting of the socio-demographic details and pre-treatment assessment questionnaire (including Visual analog scale The Medical Outcomes Study Short-Form Health Survey The hospital anxiety and depression scale Work functioning impairment scale) was filled for each subject.
15777992|NCT04630093|Diagnostic Test|Panel-based pharmacogenetic genotyping|A DNA sample by saliva (via mouthwash swish and expectorate collection) or buccal cell (via buccal brush) will be obtained for pharmacogenetic testing and questionnaires will be administered at baseline and then again at 3 months and 6 months after receiving PGx results.
15777993|NCT04630080|Device|Scalp cooling|Scalp cooling is a physical method to reduce chemotherapy-induced alopecia
15777994|NCT04630067|Drug|AZD3427|Participants will receive SC or IV dose of AZD3427 as per the arm they are randomized.
15777995|NCT04630067|Drug|Placebo|Participants will receive SC or IV dose of placebo matched to AZD3427 as per the arm they are randomized.
15777996|NCT04630054|Device|Face mask|Intervention individuals will be given cloth or surgical face masks.
15777997|NCT04630054|Behavioral|Face mask awareness|Intervention individuals will be told about the importance of wearing face masks that cover the nose, mouth, and chin. Mask by mask promoters and community and religious leaders will encourage mask wearing.
15777998|NCT04630041|Behavioral|211 Referral|Patients with one or more reported social need will be referred to 211 for community based services. 211 will reach out and contact patients for follow-up.
15778001|NCT04630015|Other|Survey Administration|Participants will complete study specific survey
15778002|NCT04630002|Drug|GSK3640254|GSK3640254 will be available as oral tablets.
15778003|NCT04630002|Drug|Darunavir/Ritonavir (DRV/RTV)|DRV/RTV will be available as oral tablets.
15778004|NCT04630002|Drug|Etravirine (ETR)|ETR will be available as oral tablets.
15778005|NCT04629989|Other|Standard Oxygen Delivery System|The standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour.
15778006|NCT04629989|Other|Double-Trunk Mask|The Double-Trunk Mask above the standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour.
15778007|NCT04629989|Other|Surgical Mask|The Surgical Mask above the standard oxygen delivery system (low-flow nasal cannula or oxygen mask) is worn by the patient for 1 hour.
15778008|NCT04629976|Drug|NCO-48 Fumarate 4 mg|2 x 2mg NCO-48 Fumarate over 28 days of therapy
15778009|NCT04629976|Drug|NCO-48 Fumarate 20 mg|2 x 10 mg NCO-48 Fumarate over 28 days of therapy
15778010|NCT04629976|Drug|Tenofovir Alafenamide 25 mg|25 mg over 28 days of therapy
15778011|NCT04629963|Other|Pain Evaluation and BPISF|Current diagnostic approaches guide evaluators to use the United Nations Istanbul Protocol (UNIP) for the assessment of torture survivors. The proposed investigation offers a novel diagnostic paradigm by which patients are evaluated by the UNIP and a validated pain screen (Brief Pain Inventory Short Form).
15778012|NCT04629950|Drug|Rimegepant|Active Agent
15778013|NCT04629950|Drug|Placebo|Placebo Comparator
15778014|NCT04629937|Other|SPECT acquisitions|All patients will undergo SPECT acquisitions with both multipurpose CZT camera and cardiac dedicated CZT camera.
15778015|NCT04629924|Device|sleeper one|anesthesic injection with sleeper one device
15778017|NCT04629911|Device|THRIVE|Patients will receive HFNO therapy during laryngomicrosurgery. Patients will undergo a gastric ultrasound examination after HFNO therapy.
15778018|NCT04629898|Behavioral|multi-task in the real world and virtual reality video sport games|This was a 2-staged intervention study. The 1st stage intervention uses multitasks in the real world including stepping exercise, ball-kicking activity and bean-bag tossing activity. The 2nd stage intervention used video sport games conveyed by Xbox Kinect. Tennis and golf games were selected.
15778019|NCT04629885|Drug|Oxytocin 400 IU vaginal gel|
15778020|NCT04629885|Drug|Placebo|Matching placebo gel with identical appearance to the test product, used as reference treatment.
15778021|NCT04629872|Drug|Fingolimod|Patients randomized to fingolimod will also receive oral fingolimod (Gilenya, Novartis) at a dosage of 0.5 mg once daily, for three consecutive days, with the first dose being given at the time in which patients are enrolled which is more than 3 hour prior to mechanical thrombectomy.
15778022|NCT04629859|Procedure|mandibular setback and maxillary advancement|12 patients will undergo mandibular setback and maxillary advancement
15778023|NCT04629859|Procedure|mandibular setback|12 patients will undergo mandibular setback
15778024|NCT04629846|Drug|Trastuzumab|Trastuzumab IV infusion in 3-week cycles. Neoadjuvant treatment: 8 milligrams per kilogram (mg/kg) loading dose for Cycle 1, followed by 6 mg/kg for Cycles 2-4.
15778025|NCT04629846|Drug|QL1209|QL1209 IV infusion in 3-week cycles. Prior to surgery (neoadjuvant treatment): 840 milligrams (mg) loading dose for Cycle 1, followed by 420 mg for Cycles 2-4.
15778026|NCT04629846|Drug|Pertuzumab|Pertuzumab IV infusion in 3-week cycles. Prior to surgery (neoadjuvant treatment): 840 milligrams (mg) loading dose for Cycle 1, followed by 420 mg for Cycles 2-4.
15778027|NCT04629846|Drug|Docetaxel|Docetaxel IV infusion in 3-week cycles. Neoadjuvant treatment: 75 mg/m2 for Cycles 1-4
15778028|NCT04629846|Procedure|surgery|All participants who are eligible for surgery will undergo surgery and have their pathologic response evaluated.
15778029|NCT04629833|Biological|MC0518|MC0518 will be intravenously infused immediately after thawing.
15778030|NCT04629833|Biological|BAT|BAT including MMF, ECP, ATG, everolimus, and RUX will be administered based on Investigator's decision.
15778031|NCT04629820|Device|Spectacles|Intervention group workers receive free glasses within one week of undergoing vision assessment (September 2021). The assessment period will be three months
15778032|NCT04629807|Procedure|Anterior Lumbar Interbody Fusion (ALIF)|Intra-Operative Anterior Lumbar Interbody Fusion (ALIF)
15778033|NCT04629794|Procedure|Posterolateral Lumbar Fusion with Demineralized Bone Fibers|Posterolateral Lumbar Fusion with Demimeralized Bone Fibers
15778034|NCT04629794|Procedure|Posterolateral Lumbar Fusion with Bone Morphogenic Protein|Posterolateral Lumbar Fusion with Bone Morphogenic Protein
15778035|NCT04629781|Drug|Docetaxel micellar|There will be three dose levels, 1-3, with each level consisting initially of a cohort containing 3 patients. One additional dose level, dose level -1, shall be allowed in the event that dose level 1 is considered too toxic
15778036|NCT04629768|Device|PuraStat|Purastat is applied to the EMR defect
15778037|NCT04629755|Behavioral|Intervention|The intervention was delivered via daily text messages to mobile phones during two weeks in the midst of the Covid-19 pandemic. Each message provided a link to a brief suggestion for an action or actions to take each day to improve relational closeness and well-being. Critical to the rationale for this intervention was the position that relationship science has developed key insights into what works and does not work to build and maintain closeness. These insights could be translated into brief and effective suggestions that individuals could implement daily, thereby quickly improving relational well-being and decreasing depression and loneliness at a critical time.
15778038|NCT04629742|Other|Seawater Pizza|A seawater pizza administered to 12 healthy subjects
15778039|NCT04629742|Other|Standard pizza|A standard pizza administered to 12 healthy subjects
15778040|NCT04629729|Drug|FT819|Experimental Interventional Therapy
15778041|NCT04629729|Drug|Cyclophosphamide|Lympho-conditioning agent
15778042|NCT04629729|Drug|Fludarabine|Lympho-conditioning agent
15778043|NCT04629729|Drug|IL-2|Biologic response modifier
15778044|NCT04629716|Drug|Medical Cannabis|Medical marijuana is defined by Florida state statue 381.986 as all parts of any plant of the genus Cannabis, whether growing or not; the seeds thereof; the resin extracted from any part of the plant; and every compound, manufacture, salt, derivative, mixture, or preparation of the plant or its seeds or resin, including low-THC cannabis, which are dispensed from a medical marijuana treatment center for medical use by a qualified patient.
15778045|NCT04629703|Drug|Fostamatinib|Fostamatinib (150 mg twice daily) for 14 days and Standard of Care
15778046|NCT04629703|Drug|Placebo|Placebo (twice daily) for 14 days and Standard of Care
15778047|NCT04629690|Other|SOLAR|The participants will obtain a multidisciplinary assessment regarding their medical conditions, medication review, cognitive assessment, functional assessment, gait and balance assessment by senior clinicians and a management plan will be implemented.
15778048|NCT04629677|Other|Electronic Health Record Review|Review of medical records
15778049|NCT04629677|Other|Quality-of-Life Assessment|Ancillary studies
15778050|NCT04629677|Other|Questionnaire Administration|Complete questionnaires
15778051|NCT04629664|Drug|FX-322|Active Comparator
15778052|NCT04629664|Other|Placebo|Placebo
15778053|NCT04629651|Drug|Captopril|Oral, to be administered per the dose escalation scheme.
15778054|NCT04629638|Other|Maternal attachment, Edinburgh depression scoring and postpartum anxiety scale scores|The results will be compared with the results of covid-negative pregnant women who gave birth in the same period.
15778055|NCT04629625|Biological|End-range mobilization|End-range mobilization performed in end-range of the tibiofemoral joints' flexion and extension
15778056|NCT04629625|Biological|Non end-range mobilization|Non end-range mobilization performed in tibiofemoral joints' loose position
15778057|NCT04629625|Biological|Placebo|Hands-on technique performed in end-range of the tibiofemoral joints' flexion and extension
15778058|NCT04629612|Procedure|Regional anesthesia|Regional anesthesia such as paravertebral block, pectoral block, superficial cervical plexus block, etc applies according to institution protocol
15778113|NCT04629170|Drug|Placebo|In order to maintain study blinding, matching placebo in identical packaging will be manufactured using an inactive powder
15778059|NCT04629599|Behavioral|Interpersonal psychotherapy for major depression following perinatal loss|Participants in the IPT condition will receive 12 group sessions and 2 individual (pre-group and 1-month booster) sessions as outlined in the manual The individual sessions prepare patients to use the group effectively, to keep group members focused on their treatment goals, and to maintain treatment gains. In addition, 3 of the 12 group sessions will invite women to include their partners or other support people to bolster the woman's social support system and to reduce conflicts over how to react to the loss. These sessions are important because relationship distress is common following perinatal loss. Our IPT intervention allows new women to enter the group every 4 weeks of the 12-week group. Group sessions are semi-structured, and each woman will cover the four group topics three times, approaching each topic from a different stage in the mourning process.
15778060|NCT04629599|Behavioral|Coping with Depression|The Coping with Depression (CWD) course is a structured, manualized psycho-educational group treatment for MDD. The CWD course is based on social learning theory which posits that depression is associated with a decrease in pleasant and an increase in unpleasant person-environment interactions. The problems shown by depressed individuals are viewed as behavioral, with cognitive patterns that can be unlearned or relearned. Its effectiveness is comparable to other forms of psychotherapy in depression. The course content is cognitive-behavioral in nature and is designed to train skills that can be used in the alleviation of depression. The skill modules focus on relaxation, cognitive skills, and behavioral activation. As in the pilot trial, CWD will consist of an individual pregroup session, 12 group therapy sessions (allowing new women to enter every 4th session) and a 1-month individual booster session to provide an identical treatment dose as the experimental condition.
15778061|NCT04629586|Other|No intervention|Observational research study
15778062|NCT04629573|Procedure|Lumber Epidural|Epidural procedure was performed by attending anesthesiologists who had completed at least 50 epidural procedures during their training. Patient was placed in the sitting position, the skin over the lumbar area was cleaned and a sterile technique was observed throughout the procedure. Skin and subcutaneous tissue were infiltrated with 1% lidocaine 2 mL at the intended site of epidural placement (L2-3 or L3-4 interspace). The lumbar epidural space was then located, using a midline approach with an 18 gauge Tuohy epidural needle via a loss of resistance technique with 2 mL of saline, 20 gauge epidural catheter was placed in each patient. We deliver an initial bolus of 20 ml bupivacaine 0.5% plus 100 mcg Fentanyl, followed by continuous infusion of bupivacaine 0.5% plus 1mcg/ml Fentanyl (3-5 ml/hr.).
15778063|NCT04629573|Procedure|General anesthesia|Anesthesia was initiated with IV fentanyl 1 µg/kg, propofol 2 mg/kg and cisatracurium 0.15 mg/kg to facilitate endotracheal intubation. After tracheal intubation, anesthesia was maintained with sevoflurane in O2 and air (FiO2 of 0.5), cisatracurium 1µg/kg/min and fentanyl 0.5 µg/ kg /h were infused. Volume-Controlled ventilation was performed in all patients. Cisatracurium and fentanyl infusion was stopped at the end of surgery, neuromuscular blockade was reversed, and the patient was extubated and send to post-anesthesia care unit.
15778064|NCT04629560|Drug|Miracle Fruit|one miracle fruit tablet of 100 mg 10-15 minutes before lunch and dinner versus supportive measures. Patients assigned to receive the miracle fruit will receive written instructions regarding the use of the fruit. Patients should put the fruit tablet or powder in the mouth and gently chew/suck to dissolve and cover the tongue with the powder
15778065|NCT04629547|Drug|Suvorexant 20 mg|Suvorexant 20mg will be taken nightly for 24 months.
15778066|NCT04629547|Drug|Placebo|Placebo will be taken nightly for 24 months.
15778067|NCT04629534|Drug|High dose Cholecalciferol|Mothers in experimental group will receive 6,000 IU of vitamin D in addition to their prenatal vitamin, daily for 3 months.
15778068|NCT04629534|Drug|Cholecalciferol|Mothers in placebo control group will receive 600 IU of vitamin D in the form of their prenatal vitamin along with placebo vitamin D.
15778069|NCT04629521|Device|CyPass Micro-Stent|The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front into the back of the eye. The device is implanted after completion of cataract surgery.
15778070|NCT04629508|Drug|itacitinib|itacitinb Immediate Release (IR) will be dosed orally twice a day
15778071|NCT04629495|Drug|Rapamycin|RAPA will be administered orally 1mg daily
15778072|NCT04629495|Other|Placebo|Placebo will be administered orally once daily
15778073|NCT04629482|Other|Brain networks activity|The brain network activity under different conditions will be evaluated by magnetoencephalography, including resting, listen to different types of music, watch different types of videos, and interacting with cognitive stimulation conditions.
15778074|NCT04629469|Diagnostic Test|Hyperfine MRI|• Patients who have a standard of care MRI, CT or US will undergo a low-field MRI utilizing Hyperfine either at the patient's bedside or in the department of Radiology. Results of the Hyperfine MRI will not be used for clinical care and will only be available to members of the research team for review.
15778075|NCT04629456|Other|neuromuscular electric stimulation|A total of eight electrodes were placed on the quadriceps femoris muscles (four on each leg): two on the vastus medialis, one on the rectus femoris muscle, and one on the vastus lateralis muscle. The stimulation protocol of the NMES consisted of a symmetrical biphasic square pulse at 75 Hz, a duty cycle of 6 seconds (sec.) on and 29 sec. off, a pulse time of 410 sec. during a session lasting 20 min. The intensity was increased to maximum individual toleration. The muscle contractions were visible and palpable.
15778076|NCT04629456|Other|Exercises|The chair-seated exercises were used in the early stages of the program because the participants were frail adults. Repetitions of toe raises, heel raises, knee lifts, knee extensions, and others were performed while seated on a chair. Hip flexions, lateral leg raises, and repetitions of other exercises were performed standing upright behind the chair and holding the back of the chair for stability. To strengthen lower extremities, a fixed weight was placed on the ankle while participants performed strengthening exercises. Weights of 0.50, 0.75, 1.00, and 1.50 kg were used in accordance with each participant's strength level as the resistance progressively increased. The exercises performed using these ankle weights included seated knee flexion and extension and standing knee flexion and extensions. Exercises using a resistance band: Resistance bands were used to strengthen lower body. Lower body exercises included leg extension and hip flexion
15778111|NCT04629183|Other|integrated clinical evaluation|30-day follow-up (telephone/database query) to define outcome Patients will receive standard care, independent of study participation.
15778112|NCT04629170|Drug|SYNB8802|SYNB8802 is formulated as a nonsterile solution intended for oral administration
15778077|NCT04629443|Drug|S 64315 (also referred as MIK665) and azacitidine|"The combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) administered via intravenous (IV) infusion over at least 2 hours.
~During the combination treatment period S64315 will be administered according to a dose escalation scheme starting at 50 mg up to 250 mg might be explored. The schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen of azacitidine administered at 75 mg/m² via subcutaneous (SC) injection for 7 days from D1 to D7 of each cycle followed by a rest period of 21 days."
15778078|NCT04629430|Other|Pre-biotic foods/drinks|2 servings per day
15778080|NCT04629404|Drug|LY03003|Firstly, intramuscularly inject 14 mg of the study drug once, continue intramuscularly inject 28 mg of the study drug once after being observed for 1 week to confirm safety, continue intramuscularly inject 42 mg of the study drug once after being observed for 1 week to confirm safety, and prepare to enter the maintenance period of 56 mg dose after being observed for 1 week to confirm safety. During the dose maintenance period, 56 mg of the test drug was intramuscularly injected once a week for a total of 4 consecutive doses.
15778081|NCT04629404|Drug|Placebo|Firstly, intramuscularly inject 14 mg of the study drug once, continue intramuscularly inject 28 mg of the study drug once after being observed for 1 week to confirm safety, continue intramuscularly inject 42 mg of the study drug once after being observed for 1 week to confirm safety, and prepare to enter the maintenance period of 56 mg dose after being observed for 1 week to confirm safety. During the dose maintenance period, 56 mg of the test drug was intramuscularly injected once a week for a total of 4 consecutive doses.
15778082|NCT04629391|Device|Total shoulder arthroplasty|A prosthesis (either anatomic or reverse) will be implanted in shoulders patients that suffer from primary glenohumeral arthritis.
15778083|NCT04629378|Drug|Meropenem Injection|Meropenem IV 6 grams
15778084|NCT04629378|Drug|Amoxicillin Clavulanate|Amx/CA oral 1000/62.5mg 2 tablets
15778085|NCT04629378|Drug|Pyrazinamide|Pyrazinamide 20-30mg/kg
15778086|NCT04629378|Drug|Bedaquiline|Bedaquiline 400mg
15778087|NCT04629378|Drug|Rifafour|Rifafour (HRZE) Standard dose
15778088|NCT04629365|Other|Ketogenic Diet|KD group consumed less than 50g/day of carbohydrates
15778089|NCT04629365|Other|Normal Diet|ND group consumed 55% of the caloric intake from carbohydrates
15778090|NCT04629352|Device|Verum Transcranial Direct Current Stimulation (tDCS)|In verum transcranial direct current stimulation (tDCS), patient will receive twice-daily for 5-days, 10-sessions course of tDCS [anode: left-DLPFC (at F3) and cathode: left-TPJ (midway between C3 and P3); electrode size: 35cm2]. For Verum-tDCS condition, 2-mA of constant current will be delivered for 20-minutes, additional ramp-up and ramp-down of 20 seconds each.
15778091|NCT04629352|Device|Sham Transcranial Direct Current Stimulation (tDCS)|In sham transcranial direct current stimulation (tDCS), each SCZ patient will receive twice-daily for 5-days, 10-sessions course of tDCS [anode: left-DLPFC (at F3) and cathode: left-TPJ (midway between C3 and P3); electrode size: 35cm2]. However, no current will be delivered beyond initial ramp-up time though the tDCS device display will indicate that 2mA current is being applied.
15778092|NCT04629339|Drug|INCB086550|INCB086550 will be administered orally twice a day.
15778093|NCT04629326|Other|68Ga-WL12 PET/CT|WL12, labeled with PET radio-nuclide ( Ga-68 )will be used as a molecular imaging tracer for PET/CT scanning
15778094|NCT04629300|Behavioral|Supportive Care Mobile Application|Tablet computer with application providing modules on skills for managing symptoms and coping.
15778095|NCT04629300|Other|Usual Care|Standard oncology care with monitoring of supportive care services usage
15778096|NCT04629287|Drug|KPCXM18|KPCXM18,blind,freeze-dried powder,ascending doses，Intravenous route
15778097|NCT04629287|Drug|Placebo|Placebo,blind,freeze-dried powder,ascending doses，Intravenous route
15778098|NCT04629274|Procedure|Blood sampling|The patients will be asked to provide at least 2 peripheral blood samples of approximately 100 milliliters each time, with a minimum of 14 days interval between these 2 samples.If the results obtained with the 2 initial samples would be of interest to the Sponsor, the patient will be asked to come back for additional samplings with a maximum of 6 additional blood draws
15778099|NCT04629261|Behavioral|Use of ECOBICI (public bicycle sharing program)|Use of ECOBICI program with and without incentive.
15778100|NCT04629248|Drug|Obinutuzumab|Open Label: An intravenous (IV) infusion of 1000 milligram (mg) of obinutuzumab will be administered at Week 0, Week 2, Week 24, and Week 26. Participants who relapse during the open-label treatment period may be eligible for further treatment.
15778101|NCT04629248|Drug|Tacrolimus|Open Label: Participants will receive tacrolimus at a starting oral dose (PO) of 0.05 mg/kilogram (kg) (participant dry weight) per day divided into two equal doses given at 12-hour intervals, titrated to serum trough level 5-7 Nanograms per millilitre (ng/mL). Optimized tacrolimus dose will be maintained for a maximum 52 weeks dependent on response and then tapered over 8 weeks. Participants who relapse during the open-label treatment period will have their dose of tacrolimus tapered over 8 weeks and may be eligible for further treatment.
15778102|NCT04629248|Drug|Methylprednisolone|Premedication: Methylprednisolone 80 mg IV will be administered between 30 and 60 minutes prior to the obinutuzumab infusion in all study periods.
15778103|NCT04629248|Drug|Acetaminophen|Premedication: Acetaminophen (650-1000 mg, or equivalent dose of a similar agent) PO or IV will be administered between 30 and 60 minutes prior to the obinutuzumab infusion in all study periods.
15778104|NCT04629248|Drug|Diphenhydramine|Premedication: Diphenhydramine (50 mg, or equivalent dose of a similar agent) PO or IV will be administered between 30 and 60 minutes prior to the obinutuzumab infusion in all study periods.
15778105|NCT04629235|Other|wonder around|wonder around after 8 hours of bedrest
15778106|NCT04629235|Behavioral|bedrest|24 hours of bedrest
15778107|NCT04629209|Drug|ONC201|ONC201 is a orally active, small molecule DRD2 antagonist that kills cancer cells but not normal cells.
15778108|NCT04629196|Drug|Ustekinumab|A second IV weight-based induction dose of Stelara at week 8
15778109|NCT04629196|Drug|Ustekinumab|A standard 90mg subcutaneous dose of Stelara at week 8
15778110|NCT04629196|Drug|Ustekinumab|All patients will receive IV ustekinumab weight-based dose at 260mg (55kg or less), 390mg (more than 55kg to 85kg), or 520mg (more than 85kg) at time point 0
15778114|NCT04629157|Device|Innova Lateral Flow Device|The Innova Lateral Flow Device will be used on anterior nasal swab specimens and RT-PCR will be performed on nose and throat swabs.
15778115|NCT04629144|Drug|Belimumab|"Belimumab administered subcutaneously 200mg weekly from week 0 to week 24.
~Both arms will have the same corticosteroid tapering scheme, with an initial dose of 60 mg/day. The following schedule of reduction of prednisone will apply to both groups as long as the disease is inactive:
~60 mg/day week (W)0-W4,
~40 mg/day W4-W6
~30 mg/day W6-W8,
~20 mg/day W8-W10,
~15 mg/day W10-W12,
~10 mg/day W12-W14,
~7.5 mg/day W14-W16,
~5 mg/day W16-W18
~2.5mg/day W18-W20.
~Stopping glucocorticoid therapy at W20 At each step, the prednisone dose will be reduced only in the absence of signs of vasculitis activity."
15778116|NCT04629144|Drug|Placebo|"Both arms will have the same corticosteroid tapering scheme, with an initial dose of 60 mg/day. The following schedule of reduction of prednisone will apply to both groups as long as the disease is inactive:
~60 mg/day week (W)0-W4,
~40 mg/day W4-W6
~30 mg/day W6-W8,
~20 mg/day W8-W10,
~15 mg/day W10-W12,
~10 mg/day W12-W14,
~7.5 mg/day W14-W16,
~5 mg/day W16-W18
~2.5mg/day W18-W20.
~Stopping glucocorticoid therapy at W20 At each step, the prednisone dose will be reduced only in the absence of signs of vasculitis activity."
15778117|NCT04629131|Biological|TNM002 Dosage 1 (10 μg/kg)|TNM002 (human monoclonal antibody against tetanus toxin), 10 μg/kg, Intramuscular injection, given once.
15778118|NCT04629131|Biological|Placebo|placebo to match TNM002 Dosage 1, given once
15778119|NCT04629131|Biological|TNM002 Dosage 2 (35 μg/kg)|TNM002 (human monoclonal antibody against tetanus toxin), 35 μg/kg, Intramuscular injection, given once
15778120|NCT04629131|Biological|Placebo|placebo to match TNM002 Dosage 2, given once
15778121|NCT04629131|Biological|TNM002 Dosage 3 (100 μg/kg)|TNM002 (human monoclonal antibody against tetanus toxin), 100 μg/kg, Intramuscular injection, given once
15778122|NCT04629131|Biological|Placebo|placebo to match TNM002 Dosage 3, given once
15778123|NCT04629131|Biological|TNM002 Dosage 4 (250 μg/kg)|TNM002 (human monoclonal antibody against tetanus toxin), 250 μg/kg, Intramuscular injection, given once
15778124|NCT04629131|Biological|Placebo|placebo to match TNM002 Dosage 4, given once
15778125|NCT04629118|Device|Selution SLR™ 018 Drug Eluting Balloon|Target lesion will be pre-dilated with high pressure non-compliant balloon, then treated with SELUTION SLR™ 018 DEB Balloon.
15778126|NCT04629105|Biological|Longeveron Mesenchymal Stem Cells (LMSCs)|Longeveron Mesenchymal Stem Cells (LMSCs)
15778127|NCT04629105|Other|Placebo|Placebo
15778128|NCT04629066|Behavioral|Remote Cardiac Rehabilitation (CR)|"Patients randomized to remote CR will be asked to use an app for cardiac rehabilitation a minimum of 3 times a week. Patients will be given an exercise prescription provided by a certified exercise physiologist.
~The exercise prescription will change each week based on refreshed data from the prior week.
~Instructional videos for each exercise are provided in the app. Patients will not be told to perform the exercise at a particular time. Instead they will be asked to complete a certain amount of exercise per week at whatever time is convenient for them. Patients randomized to remote CR will also receive App based reminders to take their medications, resources to guide healthy eating habits, and other behavioral health advice as is done as standard of care in both remote based and clinic based CR."
15778129|NCT04629040|Other|Lateral wedge insole|Lateral wedge insole for knee osteoarthritis patient
15778130|NCT04629040|Other|Ordinary insole|Ordinary insole
15778131|NCT04629027|Drug|Immune checkpoint inhibitor|the patients receive necessary treatment without special intervention
15778132|NCT04629001|Diagnostic Test|Covid-19 PCR , IGM|test for Covid-19
15778136|NCT04628975|Device|transillumination dispositif|infrared light
15778137|NCT04628962|Procedure|Collection and Raman analysis of saliva for the database|Saliva will be collected and processed for the Raman analysis. The collected data will be computed for the creation of the classification model
15778139|NCT04628936|Drug|KZR-616|KZR-616 subcutaneous injection
15778140|NCT04628923|Other|QUADRATUS LUMBORUM BLOCK|QUADRATUS LUMBORUM BLOCK BY PARASPINOUS SAGITTAL SHIFT APPROACH
15778141|NCT04628910|Other|Simulated Flotation Therapy|"The Zerobody is a new technology designed to simulate the effects of traditional Float-REST therapy, but without the contact with salt water. The system has a very thin membrane that cradles the body and provides a warm sensation, similar to that experienced in a traditional flotation tank. The system will be housed in a room that allows for significant reductions in light and sound to mimic the experience of a flotation tank. The room will contain an intercom that allows participants to communicate with study personnel in the event they need assistance. Participants will undergo 60 minute sessions twice a week for 3 weeks using the Zerobody, also termed dry floating, as one of the two interventions."
15778142|NCT04628910|Other|Traditional Float-REST Therapy|Traditional Float-REST therapy uses sensory deprivation tanks that consist of a very large warm water enclosure with a high concentration of Epsom salt to create a completely buoyant environment. This, along with a combination of temperature that is kept equal to skin temperature (94 degrees), allows the participant to eliminate the gravitational effects on the body, and along with lack of sound and low to no light (depending on comfort) allows the brain and body to completely relax for augmented physical and mental recovery. The room will contain an intercom that allows participants to communicate with study personnel in the event they need assistance. Participants will undergo 60 minute sessions twice a week for 3 weeks as one of the two interventions.
15778143|NCT04628897|Behavioral|Exposures|"Total area of available floor space inside the home (m2)
~Frequency that child plays outdoors
~Total number of physical hazards in the home (presence of open stairwells, stove height)
~Total number of fine-motor activity items available to the child
~Presence of gross-motor activity items available to the child across each category (e.g., fixed, portable: ball equipment, push/pull equipment, riding equipment, rocking and twisting equipment)
~Hemoglobin concentration (g/L)."
15778145|NCT04628884|Drug|Dosing according residual heparin|In this group the heparin doses will be simulated using a pharmacokinetic model to estimated the residual heparin amount at the end of the surgery, the protamine dose will be calculated using the residual heparin
15778149|NCT04628845|Device|Endo-perio therapy with laser 940nm|Periodontal pockets's treatment of scaling, root debridement and endodontic treatment of root canals with using laser 940nm.
15778150|NCT04628845|Device|Endo-perio therapy without laser 940nm|Periodontal pockets's treatment of scaling, root debridement and endodontic treatment of root canals
15778151|NCT04628832|Behavioral|PMP Use Mandate Letter|A letter with reminders about the mandate to check the PMP when prescribing opioids.
15778152|NCT04628832|Behavioral|Prescribing Information Letter|A letter with information about the prescriber's patients who received co-prescriptions. The letters will provide clinical background on the harms of co-prescribing and encourage prescribers to avoid co-prescribing in the future.
15778153|NCT04628832|Behavioral|Prescribing Information + PMP Use Mandate Letter|A letter combining the content of the PMP Use Mandate Letter and the Prescribing Information Letter. This letter will remind prescribers about the PMP use mandate and provide information about the prescriber's patients who received co-prescriptions.
15778154|NCT04628819|Dietary Supplement|Babybiane Imedia or placebo|Both the investigational product as well as the placebo will be administered once daily, diluted in a nursing bottle or a glass of water or cold milk, or mixed with a food suitable for the child. It may be diluted in oral rehydration solution and is to be taken preferably before a meal. Both preparations (BABYBIANE® Imedia and placebo) will have similar consistency and taste. A supplementation unit will contain 7 packs of either products, one per supplementation day.
15778155|NCT04628806|Diagnostic Test|CTC isolation by HSP70|patients will receive additional blood examinations with quantification of circulating tumor cells by HSP70 antibodies and EpCAM.
15778156|NCT04628793|Drug|PF-07258669|PF-07258669 will be prepared as an oral solution and/or suspension given in escalating single doses to be determined
15778157|NCT04628793|Drug|Placebo|Matching placebo will be prepared as an oral solution and/or suspension given in each cohort
15778158|NCT04628780|Biological|PF-07209960|PD-1 targeted IL-15 mutein
15778167|NCT04628754|Other|Exercise and protein|Home based exercise regime and dietary protein guidance
15778168|NCT04628741|Behavioral|Dynamic Coaching Model|This is a behavioral intervention which includes metacognitive strategy training and personalized strategy and external aid use training.
15778169|NCT04628741|Behavioral|Apprenticeship Approach|This is a behavioral intervention which includes explicit education about traumatic brain injury, its symptoms, and individuals who may provide assistance post-injury, metacognitive strategy training and personalized strategy and external aid use training.
15778170|NCT04628728|Other|Survey based on questionnaire (self-designed)|Participants are handed a questionnaire to asses comprehension of medical content provided in the referral letters.
15778171|NCT04628715|Device|RSA biofeedback|Biofeedback intervention based on breathing at resonance frequency
15778172|NCT04628702|Behavioral|tablet training|1.5 year training period
15778173|NCT04628689|Other|quadratus lumborum block by paraspinous sagittal shift approach|quadratus lumborum block by paraspinous sagittal shift approach
15778174|NCT04628676|Drug|tranexamic acid|Tranexamic acid is added to the irrigation fluid used in arthroscopic shoulder surgery.
15778175|NCT04628676|Drug|Epinephrine|Epinephrine is added to the irrigation fluid used in arthroscopic shoulder surgery.
15778176|NCT04628663|Drug|Dexmedetomidine|Administration
15778177|NCT04628663|Other|Normal Saline|Administration
15778178|NCT04628650|Device|Digital Pain-Management Tool|Self management digital tool for chronic pain
15778179|NCT04628637|Other|Serum protein level analysis|Serum GRP78 levels of the subjects were measured through a commercially available enzyme-linked immunosorbent assay (ELISA) kit (Human Glucose Regulated Protein 78 (GRP78) ELISA Kit, Sun Long, SL2048Hu, China), as per the manufacturer's protocol. The detection rate of this kit is 16 pg/mL.
15778180|NCT04628624|Dietary Supplement|Placebo control|8 week supplementation period, with participants consuming 2 capsules per day containing potato starch
15778181|NCT04628624|Dietary Supplement|GTE 1|8 week supplementation period, with participants consuming 2 capsules per day containing green tea extract (571mg/d)
15778182|NCT04628624|Dietary Supplement|GTE 2|8 week supplementation period, with participants consuming 2 capsules per day containing green tea extract with additional antioxidants (150mg of quercitin and 150mg of alpha lipoic acid)
15778183|NCT04628611|Device|Video laryngoscopy|Endotracheal intubation using video laryngoscopy
15778184|NCT04628611|Device|Flexible intubating laryngoscopy|Endotracheal intubation using flexible intubating laryngoscope
15778185|NCT04628598|Behavioral|Antenatal care and prenatal education with a home visit|Providing prenatal education and care by home visits to pregnant women
15778186|NCT04628585|Other|Safety and efficacy assessments|Safety evaluations, disease-specific assessments, and assessments to monitor for long-term complications of autologous transplant
15778187|NCT04628572|Drug|Ceftazidime-avibactam|Non-Interventional Study
15778208|NCT04628442|Procedure|Biopsy|A biopsy is optional and will remove a sample of inferior turbinate tissue from the nasal passage. It will be performed during a nasal polyp removal surgery already scheduled for patient care.
15778188|NCT04628559|Drug|Dexmedetomidine|dexmedetomidine was administered as a gradual bolus of 1 µg/kg/10ml 10 min before induction of anesthesia and then as an infusion of 0.4 µg/kg per min (30 ml/h). In Group K, ketamine was administered as a 0.4 mg/kg/10ml IV bolus 10 min before induction of anesthesia and in the form of 10 µg/kg per min infusion after induction (30 ml/h).
15778189|NCT04628559|Drug|Ketamine|In Group K, ketamine was administered as a 0.4 mg/kg/10ml IV bolus 10 min before induction of anesthesia and in the form of 10 µg/kg per min infusion after induction (30 ml/h).
15778190|NCT04628559|Drug|Saline|Group S was given a bolus of saline solution in 10 ml volume 10 min before induction of anesthesia, followed by 30 mL/h serum saline infusion.
15778191|NCT04628546|Behavioral|The Parenting Young Children Check-up Initial Check-up and Text Messages|Parents assigned to the intervention condition will go through the Initial Check-up, which is a brief intervention that uses motivational content to promote use of the Parenting Young Children Check-up parenting education website. They will also receive text messages and a brochure to connect them to the parenting education website.
15778192|NCT04628546|Behavioral|The Parenting Young Children Check-up Flier and Text Messages|Parents assigned to the control condition will not go through the Parenting Young Children Check-up Initial Check-up. They will only go through assessment and then see a brief flier about the Parenting Young Children. Like the intervention condition, they will also receive text messages and a brochure to connect them to the Parenting Young Children Check-up parenting education website.
15778193|NCT04628533|Behavioral|Four Month Duration Online Behavioral Weight Loss Program|"Participants meet weekly on line with other group participants for 16 weeks. The group-based online behavioral weight control program incorporates the elements of current thinking and empirical data on successful weight loss programs, including restricted calorie intake and increased physical activity. Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted, and reinforced throughout the program. Weekly group meetings in a video chat forum led by an experienced group weight control counselor are the venue for the group process, and extensive web-based resources to support behavior changes are offered. The online groups are closed such that those individuals who start the group remain in that group for the duration of their participation. Weight loss counselor will provide feedback and encouragement to participants after reviewing food diaries via weekly emails."
15778194|NCT04628533|Behavioral|Six Month Duration Online Behavioral Weight Loss Program|"Participants meet weekly on line with other group participants for 24 weeks. The group-based online behavioral weight control program incorporates the elements of current thinking and empirical data on successful weight loss programs, including restricted calorie intake and increased physical activity. Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted, and reinforced throughout the program. Weekly group meetings in a video chat forum led by an experienced group weight control counselor are the venue for the group process, and extensive web-based resources to support behavior changes are offered. The online groups are closed such that those individuals who start the group remain in that group for the duration of their participation. Weight loss counselor will provide feedback and encouragement to participants after reviewing food diaries via weekly emails."
15778195|NCT04628520|Procedure|Free gingival graft|After administration of local anesthesia, an intrasulcular incision will be made at the muco-gingival line and a partial thickness flap will be raised and sutured at the base of the newly created vestibule with resorbable mattress sutures. After the completion of the apically positioned flap, patients will receive a free gingival graft (FGG) harvested from the palate, that will be fixed with interrupted resorbable sutures to the recipient periosteal bed, free of any muscle attachment.
15778196|NCT04628520|Procedure|Collagen matrix|After administration of local anesthesia, an intrasulcular incision will be made at the muco-gingival line and a partial thickness flap will be raised and sutured at the base of the newly created vestibule with resorbable mattress sutures. After the completion of the apically positioned flap, patients will receive either a collagen matrix (CM), that will be fixed with interrupted resorbable sutures to the recipient periosteal bed, free of any muscle attachment.
15778197|NCT04628520|Procedure|Maintenance|Oral Hygiene Instruction, periodontal debridment and Supportive Periodontal Therapy
15778198|NCT04628507|Other|Spent media collection|Embryo spent culture media, otherwise discarded as per standard of care, is collected once embryos have completed in vitro culture.
15778199|NCT04628494|Biological|Epcoritamab|Following mandatory pre-medication subject will be administered epcoritamab as a subcutaneous injection.
15778200|NCT04628494|Drug|Investigator's Choice Chemotherapy|Following mandatory pre-medication subject will be administered intravenously either BR or R-GemOx.
15778203|NCT04628468|Device|moveUp|Mobile application for use in the rehabilitation of primary knee and hip arthroplasty
15778204|NCT04628468|Other|Predefined number of traditional physiotherapy sessions|exercises with a physiotherapist being physically present
15778205|NCT04628455|Device|Inversion and snaring|"Vertical umbilical 5-mm incision was made for 5-mm trocar. Pneumoperitoneum is then established with CO2 flow of 1.5-2.5 L/min keeping intraabdominal pressure between 8-12 mmHg. A two-mm incision was done at a point B [midway between umbilicus and symphysis pubis] for 2-mm port passed under direct vision and a tiny 11-blade scalpel puncture is done at the corresponding Mac-Burney's [Point C] for SGD.
~Both SGDs were used to invert the hernia sac by gradual sustained alternating traction on the round ligament. Each SGD hands to the other one till complete inversion occurs, this is known by the hernial sac hanging from internal ring without retracting-back inside the inguinal canal. Then, the MPS is introduced via 2-mm trocar at point. SGD-C passed inside the loop of MPS and re-catches the hernial sac, which is then twisted around its neck several times. MPS was closed at the neck and diathermy current is applied. Detached sac was then pushed antigradely out through the umbilical port."
15778206|NCT04628442|Procedure|Sinonasal Debridement Procedure|This is a medical procedure prescribed by the participant's physician that has been deemed necessary for patient care in order to address their chronic rhinosinusitis.
15778207|NCT04628442|Procedure|Nasal Polyp Removal|This is a surgical procedure prescribed by the participant's physician that has been deemed necessary for patient care in order to address their chronic rhinosinusitis.
15778209|NCT04628429|Drug|Erenumab|anti-CGRP-receptor monoclonal anti-body
15778210|NCT04628429|Drug|Galcanezumab|anti-CGRP-ligand monoclonal anti-body
15778212|NCT04628416|Device|PICO dressing|Use of a portative miniature negative pressure dressing system named PICO® on the split-thickness skin graft of fibula free flap donor sites
15778213|NCT04628416|Device|Conventional dressing|use of a conventional dressing (parrafin gauze) on the split-thickness skin graft of fibula free flap donor sites
15778214|NCT04628403|Other|massage|clinical interventions, of mechanophysiological origin for the treatment of symptoms corresponding to DOMS, after exercise
15778215|NCT04628403|Device|lasertherapy|lasertherapy
15778216|NCT04628403|Device|shock waves|shock waves
15778217|NCT04628390|Device|Laser|The laser application will be carried out only once, immediately after the cementation of the orthodontic appliance.
15778218|NCT04628390|Other|Placebo|Simulation laser application will be carried out only once, immediately after the cementation of the orthodontic appliance.
15778219|NCT04628377|Device|Angiography-drived Index of Microcirculatory Resistance|"From coronary angiographic images, angiography-derived IMR will be calculated based on mathematical calculation.
~Angiography-derived IMR = (hyperemic Pa x angiography-derived FFR) x (vessel length / {K x V diastole}).
~Hyperemic Pa will be estimated from resting Pa according to prespecified equation."
15778220|NCT04628351|Behavioral|Bladder Training|"Patients in the structured bladder training group were trained on lifestyle changes (nutrition, fluid management, exercise), pelvic floor muscle exercises and bladder control techniques."
15778221|NCT04628338|Drug|IFN-γ (interferon gamma-1b) injection|Dosage form: 100 mcg (2 million International Units) per 0.5 mL solution, administered subcutaneously Dose regimen: three times weekly (Weeks 0-7), once weekly (Weeks 8-12)
15778222|NCT04628325|Drug|Furosemide|Intravenous Furosemide Plus Small Hypertonic Saline Solutions (HSS)
15778223|NCT04628312|Other|Static footprint|The static footprint will measure the plantar pressures and surface area of the back of the foot, midfoot and forefoot. Subjects were instructed to stand barefoot on the force platform, participants were instructed to remain in a relaxed standing posture with feet shoulder-width apart and positioned 30 degrees from the midline.
15778224|NCT04628299|Other|Sham Laser|Sham Laser in plantar fascia
15778225|NCT04628299|Other|Myofascial Induction|Myofascial Induction in plantar fascia
15778226|NCT04628286|Other|Sham Laser|Sham Laser in plantar fascia
15778227|NCT04628286|Other|Myofascial Induction|Myofascial Induction in plantar fascia
15778228|NCT04628273|Procedure|encoscopic retrograde cholangio-pancreatography, extracorporeal shock wave lithotripsy|
15778229|NCT04628247|Device|Spring gravity bar|"contain two wooden board length (160 cm) and width (15 cm)
~contain pair of spring at every end of board
~two wooden board connect in the middle"
15778230|NCT04628221|Device|OsteoProbe System|"The OsteoProbe® System (OsteoProbe) is a bone microindentation measurement tool. The device is a measurement tool that is not intended to make a diagnosis or provide a treatment decision. There are no other available measurement tools for clinical assessment of bone's resistance to microindentation."
15778231|NCT04628208|Diagnostic Test|Spartan COVID-19 v2 System|A nasopharyngeal swab sample analyzed on the Spartan COVID-19 v2 System for the detection of SARS-CoV-2.
15778232|NCT04628143|Drug|Nafamostat Mesilate|Administered intravenously as a continuous infusion
15778233|NCT04628130|Other|Yoga Therapy|Yoga based self managed practices personalised to chronic pain patients
15778234|NCT04628117|Dietary Supplement|Oral nutritional supplementation for kidney disease|237 mls per day for 8 weeks.
15778235|NCT04628104|Radiation|cardiac magnetic resonance|"o CMR protocol:
~Cine imaging to assess regional & global ventricular function according to the AHA 16-segment model.
~T2-weighted imaging to detect extent & distribution of myocardial edema.
~Early Gd enhancement imaging to detect extent & distribution of myocardial hyperemia.
~Late Gd enhancement imaging to detect extent & distribution of myocardial necrosis.
~Single-short sequences & other acceleration techniques will be used as appropriate in patients with poor ability to hold their breath.
~Post-processing analysis will be done on a dedicated workstation"
15778236|NCT04628091|Other|Sampling on surgery day|"In the morning, the day of the surgery (the patient will be fasting):
~Occipital hair sample (without roots)
~Venous blood sample (3 tubes of 7mL)
~During the surgery:
~Sample of 0.5 to 1 cm3 of subcutaneous adipose tissue during laparoscopic umbilical access
~Collection of a portion of Ampulla proximal part and Isthmus distal part in order to obtain a piece of approximately 4 cm long (2cm of ampulla and 2 cm of isthmus) for each tube."
15778237|NCT04628078|Other|Use of echocardiography guidance for LAAC|Since August 2015, the echocardiography is routinely used by majority of operators to guide LAAC
15778238|NCT04628065|Behavioral|#BabyLetsMove|This intervention will use mobile phones to promote the adoption and maintenance of physical activity, exercise and reduced TV time among overweight or obese, Black, pregnant (<16 weeks) adolescents (15 - 19 years) enrolled in Mississippi's WIC program.
15778239|NCT04628052|Procedure|Colonoscopy|Music vs. No-Music
15778240|NCT04628039|Other|Rehabilitation-focused program|Subjects will receive 1) an initial assessment and personalized plan by a nurse care coordinator, 2) a CORE program consisting of upper and lower body exercises, and basic dyspnea management, and 3) individual symptom- and problem-focused modules identified in the initial assessment and then selected by participants as part of a personalized plan.
15778241|NCT04628026|Drug|Venetoclax|Induction cycle 1: Venetoclax will be administered orally QD, daily dose: 100mg/200mg/300mg, days 1-12 (after a 1/2/3 day ramp-up phase) (as determined during run-in phase) Induction cycle 2: Venetoclax will be administered orally QD, daily dose: 100mg/200mg/300mg, patients not in CR/CRi: days 1-12 (after a 1/2/3 day ramp-up phase) or patients in CR/CRi: days 1-14 (without ramp-up) (as determined during run-in phase) Consolidation phase: Venetoclax will be administered orally QD, daily dose: 100mg/200mg/300mg, days 1-14 (as determined during run-in phase)
15778242|NCT04628026|Drug|Placebo|Induction cycle 1: Placebo will be administered orally QD, daily dose: 100mg/200mg/300mg, days 1-12 (after a 1/2/3 day ramp-up phase) (as determined during run-in phase) Induction cycle 2: Placebo will be administered orally QD, daily dose: 100mg/200mg/300mg, patients not in CR/CRi: days 1-12 (after a 1/2/3 day ramp-up phase) or patients in CR/CRi: days 1-14 (without ramp-up) (as determined during run-in phase) Consolidation phase: Placebo will be administered orally QD, daily dose: 100mg/200mg/300mg, days 1-14 (as determined during run-in phase)
15778451|NCT04626531|Other|Control Group|The control group didn't apply any interference during the study. Participants in the control group continued their routine follow-up.
15778243|NCT04628026|Combination Product|Standard chemotherapy|"Induction cycle 1: Patients will receive cytarabine 200 mg/m2 continuous IV (days 1-7) and daunorubicin 60 mg/m2 IV (days 1-3). Induction cycle 2: Patients ≤ 60 yrs will receive cytarabine 1000 mg/m2 BID (3h IV), days 1-6, and daunorubicin 60 mg/m2 IV (days 1-3). Patients >60 yrs will receive cytarabine 1000 mg/m2 BID (3h IV), days 1-6 without daunorubicin.
~Consolidation chemotherapy option 1 consists of one cycle of mitoxantrone (10mg/m2 IV) and etoposide (100mg/m2 IV) (ME) days 1-5 (patients ≤60 yrs) or days 1-3 (patients >60 yrs). Consolidation chemotherapy option 2 consists of intermediate doses of cytarabine. Patients ≤60 yrs will receive up to 3 cycles of IDAC (single dose 1500 mg/m2 every 12 hours, days 1-3). Patients who are >60 yrs will receive up to 3 cycles of IDAC with single doses of 1000 mg/m2, every 12 hours, days 1-3. In patients >60 yrs less than 3 cycles of IDAC or dose-reduced IDAC (500 mg/m2 per single dose) may be given based on an individual risk assessment."
15778244|NCT04628026|Other|Autologous stem cell transplantation|Busulfan/Cyclophosphamide will be administered as conditioning regime. Patients may proceed to autologous HCT when they have reached CR/CRi/MLFS after at least two cycles of chemotherapy and performance status permits continuation with high-dose chemotherapy. Venetoclax will not be added to or given after the conditioning regimen.
15778245|NCT04628026|Other|Allogeneic stem cell transplantation|Generally, patients will proceed to allogeneic HCT upon completion of remission induction chemotherapy. It is however allowed, as per investigator's discretion, for a patient to receive 'bridging' consolidation chemotherapy in exceptional cases of delay towards transplantation. At baseline, HLA-compatible donor search must be initiated as soon as possible, first among siblings and second in the world donor bank for unrelated donors or cord blood. In order to avoid inappropriate delay in cases where no suitable sibling is present, high-resolution HLA typing should be performed immediately after registration, enabling a more rapid matched-unrelated donor search. In case no sibling or unrelated donor can be identified, haploidentical allogeneic HCT is allowed. Conditioning and GVHD prophylaxis will take place according to institutional guidelines. Patients who undergo allogeneic HCT will not receive venetoclax during conditioning, engraftment or after hematologic recovery.
15778246|NCT04628013|Device|Noxious Electrical Stimulation (NxES)|The NxES intervention will be applied with a pair of 2x3 inch electrodes placed orthogonally to the knee joint line with one electrode on the medial and lateral sides of the knee. The device is a commercially available unit(Chattanooga Continuum, DJO Global, Vista CA) and the parameters of the NxES include: 400 μs biphasic square wave pulses delivered at 50-100 pulses/second, using a cycle time of 10-seconds on, with a 2-second ramp-up in intensity, followed by a 10-second off period. The current intensity will be dosed over the first 2-minutes of stimulation to find the sensory perception threshold and the threshold for the first perception of a sharp, prickly buzzing sensation that they would identify as painful. Next, the current intensity will gradually be increased until the participant reports a sharp or prickly buzzing sensation that achieves a pain rating of not more than a 5/10 using a numeric pain rating scale.
15778247|NCT04628000|Other|Vitamin D|Clinical Correlation
15778248|NCT04627987|Diagnostic Test|Cardiac MRI scan|Cardiac MRI scan pre- and post- aortic valve replacement to assess degree of left ventricular remodelling, fibrosis and myocardial blood flow.
15778249|NCT04627987|Diagnostic Test|Serum biomarkers (High sensitivity troponin, NT-proBNP|Blood tests looking evidence of cardiac structural remodelling and function.
15778250|NCT04627987|Procedure|Implantable Loop Recorder|Determine post-AVR arrhythmia burden
15778251|NCT04627987|Diagnostic Test|6 minute walk test|Validated assessment of functional capacity - distance walked over 6 minute time frame.
15778252|NCT04627987|Diagnostic Test|Echocardiogram|Ultrasound assessment of heart structure and function. Standard of care in valve surgery pathway.
15778253|NCT04627974|Device|Evoke Spinal Cord Stimulation (SCS) System|A spinal cord stimulation system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude
15778254|NCT04627961|Drug|TAS-102|Eligible patients who consent to participate will receive oral TAS-102 bid for days 1-5 and 8-12 of a 28 day cycle.
15778255|NCT04627948|Diagnostic Test|Stockholm3 test|Diagnostic test: Stockholm3-test. Men from the study sites, diagnosed with prostate cancer and currently on AS and planned for rebiopsies will be invited to the study.
15778256|NCT04627935|Behavioral|The COPD Assessment Test|Used to assess symptoms in COPD patients.
15778257|NCT04627935|Diagnostic Test|Navicular Drop Test|It is the test used to measure the amount of pronation in the foot.
15778258|NCT04627935|Behavioral|International Physical Activity Questionnaires (IPAQ)|The International Physical Activity Questionnaires (IPAQ) comprises a set of 4 questionnaires. The purpose of the questionnaires is to provide common instruments that can be used to obtain internationally comparable data on health-related physical activity.
15778259|NCT04627935|Behavioral|COPD and Asthma Fatigue Scale (CAFS)|CAFS is a comprehensive, brief, patient-centered questionnaire developed to capture fatigue experienced by patients with asthma or COPD.
15778260|NCT04627935|Behavioral|Saint George Respiratory Questionnaire|Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease.
15778261|NCT04627922|Drug|N-Acetyl cysteine|The investigators will examine N-acetyl cysteine to treat concurrent tobacco use disorder and cannabis use disorder in a double-blind, placebo-controlled RCT. Sixty daily cigarette smokers with current tobacco use disorder and cannabis use disorder will be randomized to receive NAC 3600 mg per day over 8 weeks.
15778262|NCT04627922|Other|Placebo comparator|The investigators will examine N-acetyl cysteine to treat concurrent tobacco use disorder and cannabis use disorder in a double-blind, placebo-controlled RCT. Sixty daily cigarette smokers with current tobacco use disorder and cannabis use disorder will be randomized to receive placebo per day over 8 weeks.
15778263|NCT04627922|Behavioral|Cognitive behavioral therapy (CBT)|Participants in both groups will receive 8 weekly cognitive behavioral therapy sessions for substance use disorder targeting both tobacco and cannabis use.
15778264|NCT04627909|Other|Robot|The patient interacts with a robot
15778265|NCT04627909|Other|Medical Personnel|The patient interacts with medical personnel
15778266|NCT04627909|Other|Caregiver|The patient interacts with the caregiver
15778267|NCT04627896|Device|Katty focal therapy|Microwave ablation with TATO3 generator (Katty system) under guidance of ultrasound/mpMRI fusion image device Trinity
15779855|NCT04614961|Procedure|Bariatric surgery|Surgical and endoscopic therapy
15778268|NCT04627883|Other|Inspiratory-to-expiratory (I : E) ratio of 1:2|After preoxygenation and induction of anesthesia, noninvasive positive pressure ventilation with inspiratory-to-expiratory (I : E) ratio of 1:2 for 5 min before endotracheal intubation.
15778269|NCT04627883|Other|Inspiratory-to-expiratory (I : E) ratio of 2:1|After preoxygenation and induction of anesthesian, noninvasive positive pressure ventilation with inspiratory-to-expiratory (I : E) ratio of 2:1 for 5 min before endotracheal intubation.
15778270|NCT04627870|Device|drug (paclitaxel) coated balloon|use drug (paclitaxel) coated balloon catheter to treat intracranial in-stent restenosis
15778271|NCT04627870|Device|PTA balloon|use traditional PTA balloon with NMPA approval of indication for treating intracranial stenosis
15778272|NCT04627857|Device|Manual toothbrush|Patients in group 1 (''reference procedure'') receive a manual toothbrush with a small compact head to facilitate access to the posterior teeth and soft bristles.
15778273|NCT04627857|Device|Manual toothbrush and water flosser (Philips Sonicare AirFloss)|- Group 2 patients receive a manual toothbrush with a small, compact head for easy access to the posterior teeth and soft bristles. They also receive a Philips brand interdental microjet (Philips Sonicare AirFloss Ultra) which must be filled with water.
15778274|NCT04627857|Device|Sonic toothbrush|- Group 3 patients receive a rechargeable sonic electric toothbrush from Philipps with an integrated excess pressure sensor and a compact toothbrush head for easy access to the posterior teeth.
15778275|NCT04627857|Device|Sonic toothbrush (Philips Sonicare) and water flosser (Philips Sonicare AirFloss)|- Group 4 patients receive a Philips Sonicare ProtectiveClean rechargeable sonic electric toothbrush with an integrated excess pressure sensor and 2 compact toothbrush heads for easy access to the posterior teeth. They also receive an interdental microjet from Philips (Philips Sonicare AirFloss Ultra) which must be filled with water.
15778276|NCT04627844|Dietary Supplement|Immediate Feeding|Standard tube feeds begun at an earlier time point
15778277|NCT04627844|Dietary Supplement|Delayed Feeding|Standard tube feeds begun at delayed time point
15778278|NCT04627831|Drug|CE-Iohexol|Captisol-Enabled™ Iohexol as needed for the diagnostic procedure. Volume will be determined according to medical need.
15778279|NCT04627831|Drug|Iohexol|Iohexol as needed for the diagnostic procedure. Volume will be determined according to medical need.
15778280|NCT04627805|Behavioral|MyPath tool|MyPath is a reproductive decision support tool that utilizes a patient-centered approach to help women frame their reproductive decisions in the context of their goals, preferences, and health needs. This tool was developed by Dr. Lisa Callegari with funding from the Veterans Administration (VA) Health Services Research & Development to be used in primary care settings with women veterans. It is conceptually grounded in Self-Determination Theory, which postulates that health care that meets patients' psychological needs in three key domains - autonomy, competence, and relatedness - will result in improved health behaviors and health outcomes. This is particularly relevant in reproductive health care, given the highly individualized and personal nature of these decisions, and the importance of centering a woman's aspirations and goals in her health care decision making.
15778281|NCT04627792|Behavioral|IUSECAMH Parent Intervention (Waitlist)|We will use a switching replication design in which fifty guardians will be randomly assigned using a lottery to receive the intervention and fifty will be assigned to a group who will receive the intervention at a later time point
15778282|NCT04627779|Drug|preemptive analgesia with flurbiprofen axetil|give flurbiprofen axetil 15 min before surgery
15778283|NCT04627766|Device|Monitoring with VTPatch (Connected device manufactured by VitalTracer)|Patients will be monitored for 24 consecutive hours and vital signs will be recorded with VTPatch and with standard of care
15778284|NCT04627753|Drug|Rituximab, lenalidomide|Maintenance for 2 years
15778285|NCT04627740|Drug|Retroviral vector-transduced autologous T cells to express anti-ALPP CARs|Cyclophosphamide will be administered at dose of 20mg/kg for 1 day and then fludarabine will be given for the next 3 days with 35mg/m2 and then the CAR-T cells will be administered
15778286|NCT04627727|Other|low FODMAP diet|low FODMAP diet
15778287|NCT04627714|Other|Adapted Physical Activity|Intervention consists in 1h30/week of adapted fencing
15778288|NCT04627701|Device|ClearRing|ClearRing Implantation
15778289|NCT04627688|Behavioral|Time restricted feeding|Participants will be advised to eat only during a selected window of 8 hours, and no later than 4pm, with no advice on nutrition quality, quantity or caloric intake. The intervention will include no medication, no medical device, and will last for 2 weeks prior to surgery.
15778290|NCT04627688|Behavioral|Standard dietary advices|Participants will be given standard dietary advices, as recommended by the international nutrition guidelines, and thus are not different from common clinical practice.
15778291|NCT04627675|Drug|CORVax|DNA-encodable coronaviral vaccine
15778292|NCT04627675|Drug|IL-12 plasmid|cytokine
15778293|NCT04627675|Device|Cliniporator|electroporation system
15778294|NCT04627662|Behavioral|Tele-STELLA|. Tele-STELLA (Support via TEchnology: Living and Learning with Advancing Alzheimer's disease and related dementias) is a multicomponent videoconference-based intervention designed to facilitate effective management of behavioral and psychological symptoms common to the later stages of dementia.
15778295|NCT04627636|Other|Myofascial trigger points pressure (MTrP) release|Myofascial trigger points pressure (MTrP) release technique, the initial step was to recognize and find the trigger points (TP) , and The second step after TP palpation was the MTrP release technique, as follow, by one or both hands, the thumbs or four fingers of the therapist applied a maintained pressure, pushing internal toward the middle
15778296|NCT04627636|Other|Shockwave therapy application|The JEST-2000 (JOEUN Medical, Dae-Jeon, South Korea) was used for the ESWT. The application of pressure pulses of ESWT was centered around the flexor muscles with hypertonia
15778297|NCT04627636|Other|conventional therapy|Passive ROM exercises performed by the therapist and Bobath Neurodevelopmental Approach (prolonged stretch): The Intervention methods for Bobath involved the activation of key points of control for the reduction of tone
15778298|NCT04627623|Diagnostic Test|IgM and IgG antibodies assay|5 ml venous blood sample collection to assay IgM and IgM against COVID19
15778299|NCT04627610|Other|Rectal prolapse, rectocele and elytrocele|Recurrence of dyschesia on rectal prolapse, rectocele and elytrocele
15778300|NCT04627584|Combination Product|MW33 injection|a recombinant fully human antibody to coronavirus
15778301|NCT04627584|Combination Product|MW33 injection placebo|Placebo
15778302|NCT04627571|Drug|Cenegermin Ophthalmic Solution [Oxervate]|An 8-week course of topical cenegermin eye drops given 6 times daily would be started in the affected eye, in conjunction with the pre-existing medical treatment for neurotrophic keratopathy. Patients will be followed-up at 4 weeks, 6 weeks, 8 weeks, 3 months, 6 months, 9 months and 12 months (±2 weeks at each time point) after treatment. At each visit, patients will be assessed to determine the corneal epithelial defect and corneal sensation.
15778303|NCT04627558|Other|stroke patients, balance assessment|validity relability dubousset functional test
15778304|NCT04627545|Other|2h exposure to sperm for IVF|Oocytes will only be briefly (2h) exposed to progressive motile sperm for insemination
15778305|NCT04627545|Other|overnight exposure to sperm for IVF|Oocytes will be exposed for a longer duration (overnight, 16-20h) to progressive motile sperm for insemination
15778306|NCT04627532|Drug|PF-07304814|Participants will receive PF-07304814
15778307|NCT04627532|Drug|Placebo|Participants will recieve placebo
15778308|NCT04627519|Dietary Supplement|Rhea Health Tone®|Rhea Health Tone® 2 ml twice daily after the meal (every 12 hours)
15778309|NCT04627506|Device|Bilateral NIRS (Masimo, O3TM Regional Oximetry)|Bilateral NIRS will be used to measure rSO2 intraoperatively. The NIRS electrodes will be placed on fronto-temporal area and baseline values of rSO2 obtained according to manufacturer's guidelines in the operating room prior to induction of anesthesia. The NIRS screen will be concealed in the control group to ensure blinding.
15778310|NCT04627493|Behavioral|Online exercise|Participants will participate in an online exercise program on Zoom delivered by Registered Kinesiologists and Physiotherapists three times a week.
15778311|NCT04627480|Device|Fisher Wallace Neurostimulation Device|a Cranial Electrotherapy Stimulator Device (CES).
15778312|NCT04627467|Drug|Chloroquine|250mg tablet (150mg base chloroquine)
15778313|NCT04627454|Procedure|Discectomy and insertion of dynamic cervical implant in cervical disc herniation|The surgical technique included the use of a conventional anterior cervical approach and discectomy and insertion of dynamic cervical implant after discectomy without fixation
15778314|NCT04627441|Device|Transcutaneous spinal cord stimulator|DS8R Electrical Stimulator For Human Research
15778315|NCT04627441|Device|Epidural spinal cord stimulator system|Spectra WaveWriter Epidural Spinal Cord Stimulator System with CoverEdge 32 Electrode Surgical Lead
15778316|NCT04627428|Biological|RPESC-RPE-4W|RPESC-RPE-4W
15778317|NCT04627415|Behavioral|Promoting Engagement with ADHD Pre-Kindergarteners|Optimism Training includes the following strategies: 1) Identifying situations and associations 2) Determining consequences of beliefs 3) Use distractions to interrupt negative thinking 4) dispute current thinking 5) substitute positive, productive thoughts 6) practice skills to recognize/modify self-talk 7) Maintain positive changes in self-talk
15778318|NCT04627402|Drug|Conbercept and TA|Intravitreous injection of Conbercept and TA
15778319|NCT04627402|Drug|Conbercept|Intravitreous injection of Conbercept
15778320|NCT04627389|Procedure|orbicularis oris muscle Z- plasty modification of modified millard technique|After orbicularis oris muscle had been released from the overlying skin, the previously marked points using methylene blue for designing the z-plasty were shown to be followed by back-cut incisions including the OOM and inner mucosa in both medial and lateral elements without involving the overlying skin. This procedure resulted in two triangular flaps in both segments
15778321|NCT04627389|Procedure|modified millard technique|no z-plasty modification
15778322|NCT04627376|Other|Multimodal education and support program for cancer related cachexia prevention|12-weeks multimodal program includes: 4 meetings (with cancer nurse and clinical dietician). In this 4 meetings (about 30 minutes) they will have blood tests (CRP, Albumin levels), body composition measurements, questionnaires, education on their diet and symptom management related to anti cancer treatment.
15778323|NCT04627363|Procedure|Hepatic arterial infusion chemotherapy|administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 6 weeks
15778324|NCT04627363|Drug|Bevacizumab|15mg/kg intravenously every 3 weeks
15778325|NCT04627363|Drug|Toripalimab|240mg intravenously every 3 weeks
15778326|NCT04627350|Other|Response to pulmonary finding (nodule, mass)|Follow-up low-dose CT, PET-CT, tissue sampling (transparietal biopsy, bronchoscopy, resection), contrast-enhanced CT of the thorax
15778327|NCT04627337|Drug|Saccharomyces Boulardii 250 MG|Probiotic yeast in capsules
15778328|NCT04627337|Behavioral|Dietary advice following a low fermentation diet|Medical advice was delivered to patients to follow a low fermentation diet. A list of food and beverages to avoid was delivered along with specified instructions provided by a health professional
15778329|NCT04627324|Device|The smart toothbrush and smart mirror (STM) system (XiuSolution, Gyeonggi-do, Korea)|"The STM system comprises a smart mirror, which is integrated into a computer monitor, and a 3D motion-capture device inside of a modified toothbrush holder. The computer program displays a toothbrushing animation in the mirror. Toothbrush motions detected by sensors embedded inside the holder are captured and sent to the server for analysis.
~(used only during the test visits)
~Participants had to brush their teeth at home (using toothbrushes with a flat-trimmed nylon bristle of identical type and length.) for 3 min thrice daily, after meals, as recommended by the Korean Dental Association."
15778330|NCT04627324|Device|Conventional toothbrush|"toothbrushes with a flat-trimmed nylon bristle of identical type and length.
~Participants had to brush their teeth at home for 3 min thrice daily, after meals, as recommended by the Korean Dental Association."
15778331|NCT04627298|Behavioral|educational video game for preteens to support HPV vaccination|An educational video game developed for 11-12 year olds to increase interest in and decision to pursue HPV vaccination.
15778332|NCT04627285|Drug|Lacosamide|"Pharmaceutical form: Oral-solution
~Route of administration: Oral use
~Subjects will receive lacosamide in a pre-specified sequence during the Treatment Period."
15778333|NCT04627272|Device|AutoDX-DR|AutoDx-DR provides basic image interpretation for the detection of DR and diabetic macular edema (DME) and a Refer or Not Refer recommendation.
15778334|NCT04627259|Other|Thumb Disability Examination|Turkish Version of Thumb Disability Examination. The Turkish Version of Thumb Disability Examination consists of 20 questions related with thumb pain and functionality.
15779893|NCT04614636|Drug|Elotuzumab|Monoclonal Antibody
15778335|NCT04627246|Biological|Autologous Dendritic Cell Vaccine Loaded with Personalized Peptides (PEP-DC vaccine)|"SOC: gemcitabine intravenously, on days 1 and 8 of each 21-day cycle, and capecitabine orally for 14 days of a 21-day cycle. Total: 8 cycles.
~PEP-DC vaccine: At least 6 vaccinations starting with the 5th cycle of chemotherapy. Vaccine will be administered subcutaneously every 3 weeks, on day 9 (the day after last gemcitabine infusion) of each 21-day cycle (cycle 5, 6, 7 and 8), and thereafter every 4 weeks starting from the second nivolumab administration.
~Nivolumab: it will be administered intravenously, starting 3 weeks after the last chemotherapy cycle and will be given as a flat dose of 240mg every 2 weeks during the vaccination period until the last vaccine dose or at least for 8 weeks after the end of last chemotherapy cycle if vaccination stops earlier. Afterwards, it will be given as a maintenance therapy without vaccine at 480 mg (flat dose) every 4 weeks until appearance of new lesions or unacceptable toxicity for a maximum of 2 years."
15778336|NCT04627233|Drug|Human Ezrin Peptide 1 (HEP1)|"HEP-1 will be administrated s.c. into the lower abdominal wall
~induction dosage: 2 mg Ezrin in 2 ml physiological saline applied s.c.,one injection every 12 hours until symptoms disappear followed by
~maintenance dosage: 0.2 mg Ezrin in 1 ml physiological saline solution s.c 1/day for 10 days"
15778337|NCT04627233|Drug|Placebo|placebo group received normal saline in a same volume to match corresponding HEP-1 doses. Study drug was administered by qualified staff in research clinic settings; injections were given to abdominal sites on rotating basis, by anatomic quadrant.
15778338|NCT04627220|Diagnostic Test|taken venous sample|Venous blood samples taken during the operation and at the 48th hour after the operation will be examined after appropriate procedures.
15778339|NCT04627207|Drug|CKD-330 1 Tab. and D085 1 Tab.|Other names: Reference
15778340|NCT04627207|Drug|CKD-333 1 Tab|Other names: Test
15778341|NCT04627181|Drug|Ferric carboxymaltose|Single dose of ferric carboxymaltose (Encicarb, Emcure Pharmaceuticals Ltd., Pune, India) 500 mg administered intravenously in 100 ml normal saline over 1 hour via the dialysis blood line immediately following HD
15778342|NCT04627181|Drug|Hydroxycobalamin|Single dose of hydroxycobalamine (Trineurosol Hp, Tridoss Laboratories, Mumbai, India) 1000 mcg administered intramuscularly in the deltoid of the non-fistula arm immediately following HD
15778343|NCT04627181|Drug|Placebo|Single dose of 1 ml of distilled water injected intramuscularly in the deltoid of the non-fistula arm immediately following HD
15778344|NCT04627181|Drug|Placebo|Single dose of 100 ml normal saline administered intravenously over 1 hour via the dialysis blood line immediately following HD
15778345|NCT04627168|Device|Non-invasive, surface electrical stimulation device, DS5 Digitimer|Transcutaneous abdominal electrical stimulation will be delivered through the commercially available equipment, a DS5 Digitimer.
15778346|NCT04627155|Drug|LY03003|Rotigotine,extended-release microspheres
15778347|NCT04627142|Drug|BI 1701963|Tablet
15778348|NCT04627142|Drug|Camptosar®|Solution for infusion
15778349|NCT04627129|Drug|SHR2554 and Itraconazole|Single dose of oral administration of SHR2554 and Multiple dose of oral of Itraconazole Capsules
15778350|NCT04627116|Drug|Tecarfarin|Ten (10) healthy Chinese subjects received once-daily doses of Tecarfarin on fasting every morning for 14 days.
15778351|NCT04627103|Device|Self Forming Magnetic (SFM) Anastomosis System|The SFM will be placed using an endoscope in the duodenum and laparoscopically into the ileum. A compression anastomosis will be created in each of the subjects and the diversion of enteral flow from the duodenum to ileum will create a metabolic effect that will induce weight loss and impact Type 2 Diabetes. Following the diversion being created, a gastric sleeve will be created according to standard technique.
15778352|NCT04627090|Other|Data collection|Diagnostic and therapeutic data of adult patients with LCH, collected from clinical and laboratory evaluations, carried out during clinical practice.
15778353|NCT04627064|Drug|Abemaciclib|Tablet taken orally
15778354|NCT04627064|Drug|MK-6482|Tablet taken orally
15778355|NCT04627051|Device|Atherectomy and balloon angioplasty|Atherectomy and balloon angioplasty of arterial-venous graft stenosis
15778358|NCT04627025|Drug|apraglutide|Apraglutide is a peptide analogue of GLP-2 under development for treatment of SBS-IF, which acts as a full agonist at the GLP-2 receptor with in vitro potency and selectivity comparable with native GLP-2.
15778359|NCT04627012|Drug|Lenvatinib|12 mg (or 8 mg) once daily (QD) oral dosing.
15778360|NCT04627012|Drug|Opdivo|3mg/mg intravenously every 3 weeks
15778361|NCT04627012|Drug|Camrelizumab|200mg intravenously every 3 weeks
15778362|NCT04627012|Drug|Keytruda|200mg intravenously every 3 weeks
15778363|NCT04627012|Drug|Toripalimab|240mg intravenously every 3 weeks
15778364|NCT04627012|Drug|Sintilimab|200mg intravenously every 3 weeks
15778365|NCT04627012|Drug|Tislelizumab|200mg intravenously every 3 weeks
15778366|NCT04626999|Procedure|Single Bundle ACL Reconstruction|"Arthroscopy Single Bundle ACL Reconstruction is a procedure to reconstruct the ACL using one bundle.
~The procedure uses Hamstring (Gracillis muscle and Semitendinosus muscle) as a graft."
15778367|NCT04626999|Procedure|Double Bundle ACL Reconstruction|"Arthroscopy Double Bundle ACL Reconstruction is a procedure to reconstruct the ACL using Two bundles (Double bundle).
~The procedure uses Gracillis tendon as a Posterolateral bundle graft and Semitendinosus tendon as an Anteromedial bundle graft."
15778370|NCT04626973|Drug|Ezetimibe/Statin Combination therapy|For statin naive patients, patients would initially receive Ezetimibe 10 mg plus Rosuvastatin 10 mg , For non-statin naive patients, regimens are to be changed to the equivalent dose of ezetimibe+rosuvastatin combination in case of already achieved LDL-cholesterol target (<55 mg/dL) and to be dosed up than the equivalent dose of study drugs in case of not yet achieved LDL-cholesterol target.
15778371|NCT04626973|Drug|Statin monotherapy|For statin naive patients, patients would initially receive Ezetimibe 10 mg plus Rosuvastatin 10 mg , For non-statin native patients, regimens are to be change to equivalent dose of atorvastatin or rosuvastatin in case of already achieved LDL-cholesterol target (<55 mg/dL) and to be dosed up than the equivalent dose of study drugs in case of not yet achieved LDL-cholesterol target.
15778372|NCT04626973|Drug|Ezetimibe/Statin Combination therapy|For statin naive patients, patients would initially receive Ezetimibe 10 mg plus Rosuvastatin 10 mg , For non-statin naive patients, regimens are to be changed to the equivalent dose of ezetimibe+rosuvastatin combination in case of already achieved LDL-cholesterol target (<70 mg/dL) and to be dosed up than the equivalent dose of study drugs in case of not yet achieved LDL-cholesterol target.
15778373|NCT04626973|Drug|Statin monotherapy|For statin naive patients, patients would initially receive Ezetimibe 10 mg plus Rosuvastatin 10 mg , For non-statin native patients, regimens are to be change to equivalent dose of atorvastatin or rosuvastatin in case of already achieved LDL-cholesterol target (<70 mg/dL) and to be dosed up than the equivalent dose of study drugs in case of not yet achieved LDL-cholesterol target.
15778374|NCT04626947|Biological|Bezlotoxumab|Bezlotoxumab infusion
15778375|NCT04626934|Other|specific cognitive intervention|The intervention will include all together 12 sessions, each being 45 minutes, for a total of 3 weeks. The intervention will include: 4 treatments in the area of memory and attention, 4 treatments in the area of problem solving, 4 treatments in the area of planning and analysing.
15778376|NCT04626934|Other|conventional occupational therapy treatment|The intervention will include all together 12 sessions of conventional occupational therapy treatments, each being 45 minutes, for a total of 3 weeks.
15778377|NCT04626921|Drug|CNM-Au8|30 mg of CNM-Au8
15778378|NCT04626908|Drug|GC022F CAR-T cells|Each subject receive GC022F CAR-T cells by intravenous infusion
15778379|NCT04626895|Device|Paxman Scalp Cooling Device|Paxman scalp cooling device
15778380|NCT04626882|Procedure|Staged in-hospital or Immediate complete revascularization|Patients with ST-segment elevation myocardial infarction and multivessel disease will be randomized after primary PCI for IRA. All patients will be randomized to immediate complete revascularization group or staged revascularization group by 1:1 fashion. Non-IRA lesion which have equal or more than 70% diameter stenosis by visual estimation will be revascularized without FFR evaluation. Non-IRA lesion with diameter stenosis 50-70% by visual estimation will be evaluated using FFR device. In case of FFR value more than 0.8, non-IRA lesion wll be deferred without PCI. If FFR value was equal or less than 0.8, non-IRA lesion will be revascularized.
15778381|NCT04626869|Other|Evaluation of Diaphragm Movement|Diaphragmatic movement will be evaluated with ultrasonography and a 5-2 MHz convex transducer will be used. The ultrasound probe is placed between the mid-clavicular line and the anterior axillary line by directing it vertically and slightly cranially. During quiet breathing and deep breathing, diaphragm movement will be measured. The reduction in diaphragm motion will be calculated as the difference (in percent) in diaphragm motion measured before and 30 minutes after the block. Each test will be done 3 times and the values will be averaged. A decrease between 75% and 100% will be defined as complete paresis, a decrease between 25% and 75% as partial paresis, and less than 25% decrease in diaphragmatic movement will be defined as no paresis. In order to investigate the effect of continuous local anesthetic drug administration on diaphragm movement via nerve catheter, the same procedure will be repeated 24 hours after surgery.
15778382|NCT04626856|Biological|Low dosage IRV on a 0- and 28-day schedule|Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0, 28
15778383|NCT04626856|Biological|Medium dosage IRV on a 0- and 28-day schedule|Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0, 28
15778384|NCT04626856|Biological|High dosage IRV on a 0- and 28-day schedule|Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28
15778385|NCT04626856|Biological|Low dosage IRV on a 0- and 28-day schedule|Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28
15778386|NCT04626856|Biological|Medium dosage IRV on a 0- and 28-day schedule|Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28
15778387|NCT04626856|Biological|High dosage IRV on a 0- and 28-day schedule|Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28
15778388|NCT04626856|Biological|Low dosage IRV on a 0- and 28-day schedule|Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28
15778389|NCT04626856|Biological|Medium dosage IRV on a 0- and 28-day schedule|Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28
15778390|NCT04626856|Biological|High dosage IRV on a 0- and 28-day schedule|Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28
15778391|NCT04626856|Biological|Low dosage IRV on a 0- and 28-day schedule|Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28
15778392|NCT04626856|Biological|Medium dosage IRV on a 0- and 28-day schedule|Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28
15778393|NCT04626856|Biological|High dosage IRV on a 0- and 28-day schedule|Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28
15778394|NCT04626856|Biological|Low dosage IRV on a 0- , 28- and 56-day schedule|Inactivated Rotavirus vaccine (Vero cell) of 80EU/0.5ml on day 0,28,56
15778395|NCT04626856|Biological|Medium dosage IRV on a 0- , 28- and 56-day schedule|Inactivated Rotavirus vaccine (Vero cell) of 160EU/0.5ml on day 0,28,56
15778396|NCT04626856|Biological|High dosage IRV on a 0- , 28- and 56-day schedule|Inactivated Rotavirus vaccine (Vero cell) of 320EU/0.5ml on day 0,28,56
15778397|NCT04626856|Biological|Placebo on day 0, 28|Two doses of placebo at the vaccination schedule of day 0,28
15778398|NCT04626856|Biological|Placebo on day 0, 28, 56|Three doses of placebo at the vaccination schedule of day 0, 28,56
15778399|NCT04626843|Other|Intermittent fast|16/8 fasting method: fast for 16 hours of the day with an 8 hours feeding window for a duration of 3 months.
15778400|NCT04626830|Other|Mobile Application Intervention|Participants appointed to the intervention group will receive the mobile application intervention for six months after enrollment. The mobile app (OKTED) intervention will consist of completing responding to weekly assessments regarding symptoms, side effects, and medication adherence, as well as receiving personalized feedback about responses.
15778401|NCT04626817|Device|Isokinetic device (Biodex System 4)|The measurement of muscle strength with isokinetic device
15778402|NCT04626804|Other|Remember Stuff: A Dyadic-focused Technology to Support Persons with Alzheimer's Disease in the Community|testing the usability, perceptions, and acceptability of R/S among dyads of older adults with early Alzheimer's disease and other related dementias
15778403|NCT04626791|Drug|Acalabrutinib|Given PO
15778404|NCT04626791|Drug|Bortezomib|Given SC
15778405|NCT04626791|Drug|Cyclophosphamide|Given IV
15778406|NCT04626791|Drug|Cytarabine|Given IV
15778407|NCT04626791|Drug|Doxorubicin Hydrochloride|Given IV
15778408|NCT04626791|Drug|Prednisone|Given PO
15778409|NCT04626791|Biological|Rituximab|Given IV
15778410|NCT04626791|Biological|Rituximab and Hyaluronidase Human|Given IV
15778411|NCT04626778|Drug|Peroxyl Mouthwash|Mouthwash
15778412|NCT04626778|Drug|Placebo Mouthwash|Mouthwash
15778413|NCT04626765|Drug|CD19 CAR-T|CD19 CAR-T infusion for pediatric patients with CD19 positive tumor cells
15778414|NCT04626765|Drug|CD22 CAR-T|CD22 CAR-T infusion for pediatric patients with CD22 positive tumor cells
15778415|NCT04626765|Drug|CD 19+22|CD19+22 CAR-T infusion for pediatric patients with CD19 positive and CD22 positive tumor cells
15778416|NCT04626765|Drug|Fludarabine|25mg/㎡ for D-4、D-3 and D-2
15778417|NCT04626765|Drug|Cyclophosphamide|500mg/㎡ for D-3 and D-2
15778418|NCT04626752|Drug|BCMA CAR-T|Volunteers will be treated with BCMA CAR-T cells
15778419|NCT04626752|Drug|Fludarabine|25mg/㎡ for D-4、D-3 and D-2
15778420|NCT04626752|Drug|Cyclophosphamide|500mg/㎡ for D-3 and D-2
15778421|NCT04626739|Drug|CD19 CAR-T|CD19 CAR-T for CD19 positive R/R non-Hodgkin lymphoma
15778422|NCT04626739|Drug|CD22 CAR-T|CD22 CAR-T for CD22 positive R/R non-Hodgkin lymphoma
15778423|NCT04626739|Drug|CD19+CD22 CAR-T|CD19+CD22 CAR-T for CD19 positive and CD22 positive R/R non-Hodgkin lymphoma
15778424|NCT04626739|Drug|Fludarabine|25mg/㎡ for D-4、D-3 and D-2
15778425|NCT04626739|Drug|Cyclophosphamide|500mg/㎡ for D-3 and D-2
15778426|NCT04626726|Drug|CD19 CAR-T|CD19 CAR-T infusion for patients with CD19 positive tumor cells
15778427|NCT04626726|Drug|CD22 CAR-T|CD22 CAR-T infusion for patients with CD22 positive tumor cells
15778428|NCT04626726|Drug|CD19+CD22 CAR-T|CD19+CD22 CAR-T infusion for patients with CD19 positive and CD22 positive tumor cells
15778429|NCT04626726|Drug|Fludarabine|25mg/㎡ for D-4、D-3 and D-2
15778430|NCT04626726|Drug|Cyclophosphamide|500mg/㎡ for D-3 and D-2
15778431|NCT04626713|Device|Brain-Computer Interface|Brain-computer Interface (BCI) is a direct communication pathway between a human brain and an external device. Electroencephalography (EEG) is the best studied non-invasive interface facilitating such communication. Our technology will deliver a mindfulness-based anxiety regulation intervention through a neuro-/ bio-feedback-based game interface that is driven by an EEG algorithm.
15778432|NCT04626700|Device|iNAP|iNAP for the treatment of OSA
15778433|NCT04626700|Device|CPAP|CPAP for the treatment of OSA
15778434|NCT04626687|Device|test DCB|use paclitaxel coated coronary balloon catheters to treat SVD
15778435|NCT04626687|Device|RESTORE DCB|use paclitaxel coated coronary balloon catheters(RESTORE DCB) with NMPA approval indication for treating SVD
15778436|NCT04626674|Genetic|SRP-9001|Single IV infusion of SRP-9001
15778437|NCT04626661|Device|COMET measurement system|Photonics Healthcare B.V. has developed an innovative non-invasive bedside monitoring system to measure Cellular Oxygen METabolism (the COMET).The COMET's non-invasive cutaneous mitoPO2 measurements rely on the protoporphyrin IX-triple state lifetime technique (PpIX-TSLT). This technique measures oxygen by oxygen-dependent quenching of delayed fluorescence lifetime of 5-aminolevulinic acid-induced mitochondrial PpIX (protoporphyrin IX). PpIX is the final precursor of haem in the haem biosynthesis pathway and is synthetized in the mitochondria. Administration of exogenous 5-aminolevulinic acid enhances PpIX to detectable levels and enhances mitochondrial origin of the delayed fluorescence signal. Measurements are based on the detection of time of extinction of red light emitted by the tissue following excitation with green light. The technique has been tested and calibrated for use in isolated organs and in vivo.
15778438|NCT04626648|Behavioral|Pause with a sugar containing drink|Three-minute long intraoperative pause, including a sugar-containing drink
15778439|NCT04626635|Drug|REGN7075|Intravenous (IV) infusion will be administered every week (QW) or every 3 weeks (Q3W)
15778440|NCT04626635|Drug|cemiplimab|administered concomitantly Q3W by IV infusion
15778441|NCT04626622|Drug|Kagocel|Investigators could prescribe other drugs in frame of routine clinical practice
15778442|NCT04626622|Drug|No one|Investigators don't prescribe any antiviral drugs in frame of routine clinical practice
15778443|NCT04626609|Other|Biopsy samples|Esophageal mucosal biopsies are collected during gastroscopy
15778444|NCT04626609|Other|Blood samples|Blood will be drawn by venipuncture into citrate- or EDTA-containing vacutainer tubes and into serum tubes
15778445|NCT04626596|Drug|Radiopaque Etonogestrel (ENG) Implant|68 mg subdermal implant
15778446|NCT04626583|Biological|Allogeneic MSC|Subconjunctival Injection of Allogeneic Mesenchymal Stromal Cells
15778447|NCT04626570|Other|Cognitive and Behavioral Therapy|12 sessions of CBT using a standardized approach
15778448|NCT04626557|Procedure|biopsy|biopsy of the endometrium
15778449|NCT04626544|Device|Body-worn inertial sensors|The device typically includes accelerometers that capture body accelerations in three directions (anteroposteriorly, mediolaterally and vertically) and gyrometers that capture rotations (yaw, pitch and roll). The method of measuring gait using body-worn inertial sensors has been found reliable [15] and valid [20]. This project will use Opal sensors and the Mobility Lab software from the manufacturer APDM (https://www.apdm.com/wearable-sensors/).
15778450|NCT04626531|Other|Web-Based Education|Participants in the intervention group had unlimited access to the Web site, free of charge. The Web site was designed to run on personal computers and smartphones.
15778460|NCT04626492|Diagnostic Test|Quantitative MRI imaging|Dynamic contrast enhanced magnetic resonance imaging,Intravoxel incoherent motion (IVIM) diffusion-weighted magnetic resonance imaging,Iterative decomposition of water and fat with echo asymmetry and least squares estimation quantification sequence
15778466|NCT04626466|Other|Biological investigations|(complete blood count, platelet count, renal function evaluation)
15778467|NCT04626453|Behavioral|2-month home moderate-intensity exercise|The 2-month exercise will be conducted at the participants' homes. Participants will be recommended to perform the combined exercise, which consists of the resistance exercise and walking at a faster speed than leisure walking at a moderate-intensity, for 6 days/week. They can decide which day they won't perform the exercise. Participants will be encouraged to do progressive resistance exercise and walking twice a day, once in the morning and the other time in the afternoon. Resistance exercise will be suggested to perform every other day for three days/week and walking as the aerobic exercise will be on alternate days for three days/week.
15778468|NCT04626440|Procedure|Diagnostic stage or the Clinical outcome|After enrollment, individual subject will be assigned into one of the four groups according to the medical management received, the diagnostic stage of breast cancer (BC), or the clinical outcome of BC at enrollment.
15778469|NCT04626427|Device|WavelinQ™ EndoAVF System|AVF endovascular creations using the WavelinQ™ EndoAVF System
15778470|NCT04626414|Drug|Ferric maltol capsule|single dose of 30 mg capsule
15778471|NCT04626414|Drug|Ferric maltol suspension|single dose of 30mg (5ml) oral suspension
15778472|NCT04626401|Behavioral|Forearm immobilization|Two days of forearm immobilization
15778473|NCT04626375|Drug|Bioarginine|In the Bioarginine group the partecipants take bioarginine (2 vials per os of 1.66 g every 12 hours) for 4 week
15778474|NCT04626375|Drug|Placebo oral tablet|In the Placebo group the participants take bio-arginine (2 vials per os of 1.66 g every 12 hours) for 4 week
15778475|NCT04626362|Other|Cranberry juice|Cranberry juice cocktail will be provided by Ocean Spray Cranberries, Inc.
15778476|NCT04626362|Other|Placebo juice|Apple juice added with flavor and colorants will be provided by Ocean Spray Cranberries, Inc.
15778477|NCT04626349|Other|FOCUS+ (face-to-face nurse-led intervention)|"Home-based psycho-educational intervention consisting of two 90-minute home visits and one 30-minute video-conferencing session, conducted by a trained intervention nurse over a period of 12 weeks (4 weeks between each session).
~The intervention is comprehensively manualized and there is a protocol to guide delivery of the intervention for each home visit and video call. The content of the sessions is always tailored to the needs of the dyads, so certain topics can be discussed more in-depth and specific information can be shared. The nurses who will deliver the FOCUS+ intervention will receive an extensive online training and additional continuous follow-up training to provide them with the knowledge and skills required to successfully implement the intervention. A FOCUS+ core booklet is provided as a supporting guide for the dyads that they can refer to at their own discretion and reinforces key intervention messages linked to the core components of the intervention."
15778478|NCT04626349|Other|iFOCUS (web-based intervention)|"Self-managed psycho-educational intervention that is completed autonomously by the patient-caregiver dyads together. It encompasses four sessions (with three weeks between each session) over a period of 12 weeks.
~The sessions are completed simultaneously by the patient and the family caregiver, sitting side by side at a computer. Patient-caregiver dyads have flexibility as to when they want to complete the intervention session. Based on the information patients and caregivers provided at enrollment and during the web-based sessions, they receive tailored individual and dyadic messages. An online personal workbook is provided containing the results of the interactive exercises that are provided to the dyads during the web-sessions. Any information brochures, leaflets and information sheets that the dyad indicated as 'of interest to them' during the web-sessions will be included as a hyperlink in their personal workbook."
15778479|NCT04626336|Procedure|Cystectomy|Cystectomy
15778480|NCT04626323|Procedure|Roux-en-Y gastric bypass|"Pneumoperitoneum closed with Veress needle
~Identification of Treitz angle
~Measurement of biliary loop (50 cm)
~Bowel transection with linear stapler (white load)
~Measurement of the alimentary limb (100 cm)
~Laterolateral Entero-anastomoses (white load)
~Construction of gastric pouch distant about 3 cm from the esophageal-gastric junction with stomach section in the small curvature.
~Linear cutting anastomosis (gastrojejunostomy) from about 1 to 1.2 cm
~Anastomosis integrity evaluation by methylene blue test and/or perioperative air.
~Expected surgical time: 60 minutes"
15778481|NCT04626323|Drug|Best medical treatment|Patients will also receive standard of care medical therapy for DKD (ACEI or ARB + SGLT2i) and T2DM (metformin, glitazones, incretin therapy - DPP4 inhibitor and GLP-1 analogs - and insulin, if necessary).
15778482|NCT04626310|Behavioral|Dialectical behavior therapy - emotion regulation skills training|"Arm 1. Dialectical behavior therapy - emotion regulation skills training follows the emotion regulation skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
~Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions."
15778483|NCT04626310|Behavioral|Dialectical behavior therapy - interpersonal effectiveness skills training|Arm 2. Dialectical behavior therapy - interpersonal effectiveness skills training follows the interpersonal effectiveness skills DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition. This group involves 6 weekly sessions.
15778484|NCT04626310|Behavioral|Interpersonal psychotherapy|Arm 3. Non-skills-oriented interpersonal psychotherapy group follows evidence-based principles on common factors in a group therapy context. This group involves 6 weekly sessions.
15778487|NCT04626284|Procedure|Heart Transplantation|Heart Transplantation
15778489|NCT04626258|Other|L-Mesitran|The first month apply every day one sachet, the next five months apply every week one sachet.
15778490|NCT04626245|Behavioral|Mindfulness training|Phone-delivered brief mindfulness training based on principles of MBSR
15778491|NCT04626232|Procedure|N-SLEEVE technique|The N-SLEEVE technique (figure 2) consists of creating a gastric total fundoplication (Nissen technique) before to perform the removal of 2/3 of the stomach (SLEEVE technique).
15778492|NCT04626232|Procedure|SLEEVE|SLEEVE Technique : Removal of 2/3 of the stomach
15778493|NCT04626219|Other|Imaging|Imaging - Magnetic Resonance Imaging (MRI) scan of their heads
15778494|NCT04626219|Behavioral|fast|hungry state - refrain from eating after lunch at 12 noon until 9 a.m. the next morning
15778495|NCT04626219|Behavioral|regulated meals|standardized diet from noon until 9 a.m. the next day
15778496|NCT04626193|Drug|Doxycycline|Doxycylcine 100 mg bid ,esomprazole 20 bid,levofloxacineq.d,Tinadizole 500 bid
15778497|NCT04626193|Drug|Levofloxacin 500mg|Levofloxacin 500 mg qd, amoxicillin 500 2cab bid,Tinadizole 500 bid, esomprazole 20 bid
15778498|NCT04626180|Procedure|Extubation|Extubation is the removal of an endotracheal tube (ETT), which is the last step in liberating a patient from the mechanical ventilator.
15778499|NCT04626180|Procedure|Manual Hyperinflation|Providing a larger tidal volume than baseline tidal volume to the patient and using a tidal volume which is 50% greater than that delivered by the ventilator
15778500|NCT04626167|Procedure|Concomitant Renal and Urinary Bladder Allograft Transplantation|This is a single-center, prospective, single-group unblinded phase I study that will enroll subjects with chronic kidney disease secondary to bladder dysfunction or bladder absence that is refractory to medical treatment and requires surgical intervention to prevent long-term sequelae. Patients will undergo a cadaveric donor bladder transplant in addition to or after their kidney transplant rather than using intestinal segments for bladder reconstruction or contruction.
15778501|NCT04626154|Diagnostic Test|Objectively monitoring thoracoabdominal asynchrony|Objectively monitoring thoracoabdominal asynchrony
15778502|NCT04626141|Drug|Abaloparatide|Abaloparatide will be dispensed as a 30-day supply of disposable pen injections of the standard, FDA approved dosage (80 mcg abaloparatide).
15778503|NCT04626141|Drug|Placebo|Placebo will be dispensed as a 30-day supply of disposable pen injections.
15778504|NCT04626128|Drug|CLS-AX|injectable suspension of small molecule tyrosine kinase inhibitor (TKI)
15778505|NCT04626128|Drug|Anti-VEGF|Standard of care therapy used to block vascular endothelial growth factor
15778506|NCT04626102|Behavioral|Healthy Eating Attitudes and Behaviours Group Program (Experimental Group Condition)|"The program has been developed by Clinical Psychologist Başak İnce and Psychiatrist Prof. Dr Başak Yücel. The session topics and contents of this program were based on the Fairburn (2008)'s book titled Cognitive- Behavior Treatment and Eating Disorders and 10-week online version of StudentBodies program designed by Saekow and her colleagues (2015). Program protocol was written based on Fairburn (2008)'s book titled Cognitive- Behavior Treatment and Eating Disorders and Fursland and her colleagues (2007)'s book titled Overcoming Disordered Eating.
~This program aimed to inform participants about the causes and consequences of eating disorders, teach cognitive and behavioural techniques to change their unhealthy eating attitudes and behaviours, and provide support during their attitudinal and behavioural changes. Each week, participants were asked to complete homework activities which were related to topics covered in each session."
15778507|NCT04626102|Behavioral|Eating Disorders and Body Dissatisfaction: A Group Work (Active Control Group Condition)|"This single-session group program was designed as an active control group for the purpose of this study. The content of the program was prepared based on Stice and his colleagues (2013)'s four - sessions Body Project eating disorders prevention program. This single-session program aimed to inform participants about causes and consequences of eating disorders, and discuss thin ideal messages created by media and the negative impact of these messages on women's body images, and address possible ways of countering these messages. Detailed information regarding the covered topics and video presentations in the group session is provided below."
15778508|NCT04626089|Drug|metformin glycinate|Participants randomized to metformin glycinate wil take 620 mg bid (PO) plus standard treatment for 14 days
15778509|NCT04626089|Drug|Placebo oral tablet|Participants randomized to placebo will take a tablet bid (PO) plus standard treatment for 14 days
15778510|NCT04626076|Other|Comparative Observational Cohort Study|This is a comparative observational cohort study; therefore, no preventive interventions, visits or laboratory tests are mandated. Dosing and duration of potential prophylactic treatment is at the discretion of the institution and/or healthcare provider, in accordance with regular local practice. However, serology testing for SARS-CoV-2 antibodies will be offered to the first 50% of participating HCWs per country, at enrollment and at the last follow-up (i.e. at Week 12)
15778511|NCT04626063|Drug|Magnesium|Patients were treated with etodolac 400mg twice a day plus magnesium oral supplementation once a day for acute low back pain and clinical evaluation of participants was performed at first admission to emergency department, at 4th and 10th days after the initiation of designated treatment
15778512|NCT04626063|Drug|NSAID|Patients were treated with etodolac 400mg twice a day for acute low back pain and and clinical evaluation of participants was performed at first admission to emergency department, at 4th and 10th days after the initiation of designated treatment
15778513|NCT04626063|Drug|paracetamol|Patients were treated with etodolac 400mg twice a day plus 500mg paracetamol twice a day paracetamol for acute low back pain and and clinical evaluation of participants was performed at first admission to emergency department, at 4th and 10th days after the initiation of designated treatment
15778514|NCT04626050|Behavioral|Medical Music|Participants randomized to this condition will complete 4 medical music sessions over the course of 2 weeks
15778515|NCT04626050|Behavioral|Narrative Writing|Participants randomized to this condition will complete 4 narrative writing sessions over the course of 2 weeks
15778516|NCT04626050|Behavioral|Prolonged Exposure Therapy|Psychotherapy including imaginal exposure for PTSD
15778517|NCT04626050|Behavioral|Interpersonal Psychotherapy|Psychotherapy that focuses on the effects of PTSD on current interpersonal functioning
15778518|NCT04626037|Behavioral|WECS Relational Toolkit|The Cuddle and Calm Book, The Mommy Baby Book, mother and child mutual narrative, the Bottle of Emotions, and the WECS for emotional connection, make up the WECS Relational Health toolkit.
15778519|NCT04626024|Other|Imatinib Mesylate, Dasatinib, Nilotinib or Bosutinib Withdrawal|Stop taking TKI medication
15778520|NCT04626024|Drug|Imatinib Mesylate, Dasatinib, Nilotinib or Bosutinib Re-initiation|Re-start TKI medication
15778521|NCT04626011|Procedure|Tooth extractions|After blood collection tests, Periodontal analysis, Orthopantomography and Anamnestic record each group will receive a full mouth disinfection and needed extractions.
15778522|NCT04625998|Behavioral|Enhanced CATCH Elementary School Program|Enhanced CATCH Elementary School Program is a Coordinated School Health Program that includes the CATCH Coordination Guide.
15778523|NCT04625998|Behavioral|CATCH Early Childhood (CEC)|Implementation of the CATCH Early Childhood coordinated nutrition and physical activity program for Early Care and Education (ECE) centers.
15778524|NCT04625985|Drug|Metformin Glycinate|Participants randomized to metformin glycinate will take 620 mg bid (PO) for 14 days plus standard treatment
15778525|NCT04625985|Drug|Placebo oral tablet|Participants randomized to placebo will take a tablet bid (PO) for 14 days in plus standard treatment
15778526|NCT04625972|Drug|AZD7442|Single dose (× 2 IM injections) of 300 mg of AZD7442 on Day 1.
15778527|NCT04625972|Drug|Placebo|Single dose (× 2 IM injections) of saline placebo on Day 1.
15778528|NCT04625959|Behavioral|Behavioral Therapy for Eating Disorders|Change behaviors that maintain binge eating (e.g. rigid dietary restriction outside of binge episodes, irregular or chaotic eating patterns).
15778529|NCT04625959|Behavioral|MABT: Mindful Awareness|Integrates behavioral treatment for eating disorders with a set of psychological strategies, specifically mindful awareness, designed to enhance self-regulation. Mindful awareness strategies include developing inner and outer wisdom, formal meditation, and shifting awareness to the present moment. Mindful awareness skills also include increasing awareness of thoughts, feelings, physical sensations, and hunger and fullness cues.
15778530|NCT04625959|Behavioral|MABT: Values|Integrates behavioral treatment for eating disorders with a set of psychological strategies, specifically values, designed to enhance self-regulation. Values skills include identifying and clarifying values, living a values life, making values-consistent decisions, addressing competing values, values awareness, and using values to address negative moods.
15778531|NCT04625959|Behavioral|MABT: Emotion Modulation|Integrates behavioral treatment for eating disorders with a set of psychological strategies, specifically emotion modulation, designed to enhance self-regulation. Emotion modulation skills include long-term habits for emotion regulation, coping strategies, crisis management, and cognitive reappraisal.
15778532|NCT04625959|Behavioral|MABT: Distress Tolerance|Integrates behavioral treatment for eating disorders with a set of psychological strategies, specifically distress tolerance, designed to enhance self-regulation. Distress tolerance skills include psychological acceptance, uncoupling, willingness, and dealing with dirty distress.
15778533|NCT04625946|Drug|Metformin|"Metformin immediate release will be initiated at 250 milligrams (mg) daily (orally), and increased as tolerated to 2000 mg daily over a four week period. If a patient is unable to tolerate a dose increase they will return to their last tolerated dose after omitting one days dosing. Six weeks after the initiation of drug the patient will undergo (standard of care) ablation with the intent of achieving rhythm control.
~Participants will stay on the metformin 12 months after the ablation. In addition, all participants will receive education on lifestyle changes and exercise which are standard of care as well as have a discussion with their treating electrophysiologist and receive a handout."
15778534|NCT04625946|Behavioral|Recommendations for lifestyle modification.|All subjects will receive education on lifestyle changes and exercise which are standard of care. This will include discussion with their treating electrophysiologist and a handout.
15778535|NCT04625946|Device|AliveCor|Device will be used in order to record an electrocardiogram during symptoms perceived to be AF. All patients will be instructed to transmit at least once per week.
15778536|NCT04625933|Other|No intervention|No intervention
15778537|NCT04625920|Device|SootheVR: AppliedVR, Los Angeles, California|a head-mounted display
15778538|NCT04625907|Drug|Irinotecan|antineoplastic enzyme inhibitor
15778539|NCT04625907|Drug|Actinomycin D|Antineoplastic agent that is a polypeptide antibiotic
15778540|NCT04625907|Drug|Doxorubicin|An anthracycline topoisomerase inhibitor isolated from streptpmyces peucetius var. casesius
15778541|NCT04625907|Drug|Ifosfamide|chemotherapeutic agent chemically related to the nitrogen mustards and is a synthetic analog of cyclophosphamide
15778542|NCT04625907|Drug|Vincristine|anti neoplastic vinca alkaloid agent
15778543|NCT04625907|Drug|Vinorelbine|vinca alkaloid with a role as an antineoplastic agent
15778544|NCT04625907|Drug|Cyclophosphamide|Precursor of an alkylating nitrogen mustard antineoplastic and immunosuppressive agent
15778545|NCT04625907|Drug|Temozolomide|oral antineoplastic alkylating agent
15778546|NCT04625907|Radiation|radiotherapy|Ionising radiation
15778547|NCT04625894|Radiation|Stereotactic Ablative Radiotherapy (SABR)|To irradiate as many metastatic lesions as possible, in the precondition that normal tissues can tolerate. Target dose will be adjusted depending on site of the lesion and organs at risk (BED > 100Gy). Sequence of irradiation for multiple metastases will be at the discretion of the investigators based on their experience.
15778548|NCT04625894|Drug|Camrelizumab for injection (200 mg, iv), D1, Q2W, 14-day cycle|Administration of Carrelizumab will be started within one week upon SABR completion, and will be continued for up to two years until disease progression, unacceptable toxicity or patient withdrawal.
15778549|NCT04625881|Dietary Supplement|Apple derived fiber|This is a combination of soluble and insoluble fiber
15778550|NCT04625868|Other|Educational video|Patients will watch a preoperative educational video on proper opioid use and disposal.
15778551|NCT04625855|Drug|TBPM-PI-HBr|TBPM-PI-HBr (3 x 200 mg tablets) once
15778552|NCT04625842|Other|Focus group interview|Group interview with patients who received radiation treatment
15778553|NCT04625816|Device|whole body tilt device (Spine Balance 3D)|The symmetry of the deep muscle was evaluated using a whole body tilt device (Spine Balance 3D, Cyber Medic Co., Ltd., Korea). Spine Balance 3D can evaluate the maintenance strength and maximum strength of the core muscles, and perform a personalized core muscle training program based on the evaluated results.
15778637|NCT04625088|Other|Standardized liquid test meal|During this study visit, a standardized liquid test meal will be administered. Blood samples will be collected at baseline and then every 30 minutes for 4 hours after test meal.
15778664|NCT04624880|Device|Giant magnetoresistive sensor (GMR)|Giant magnetoresistive sensor analyzes genetic polymorphisms in patient samples.
15778554|NCT04625803|Drug|Camrelizumab , apatinib and chemotherapy|"Camrelizumab 200 mg, IV infusion on Days 1 each 14-day cycle
~Apatinib 250mg oral administration once a day, for two months
~mFOLFOX6 oxaliplatin 85 mg/m^2 IV infusion on Day 1 of each14-day cycle. Fluorouracil: 400 mg/m2 as a bolus injection given after a two-hour leucovorin infusion at a dose of 400 mg/m2. The loading dose is then followed by a 46-hour 5-fluorouracil infusion of 2,400 mg/m2 via a pump programmed to provide a constant drug infusion rate."
15778555|NCT04625790|Device|Repetitive transcranial magnetic stimulation|"Transcranial Magnetic Stimulation(TMS) has been used for diagnostic and therapeutic purposes in the treatment of many neurological and psychiatric diseases such as stroke, multiple sclerosis, myelopathy, amyotrophic lateral sclerosis, movement disorders, epilepsy, and depression. It is a way to stimulate the targeted areas in the cerebral cortex without invasive methods. The application of TMS in the aphasia usually consists of repetitive stimulations, in order to activate or deactivate the target area.
~In this study, 10 sessions of 1-Hz low frequency rTMS for 20 minutes will be applied to the inferior frontal gyrus of the right frontal lobe."
15778556|NCT04625790|Other|Speech therapy|Speech therapy will be given to each patient by the same therapist, and the treatment will last 10 days, 60 minutes a day. It will consist of exercises to improve the articulation and comprehension.
15778557|NCT04625777|Behavioral|Mindfulness Based Stress Reduction|"Mindfulness Based Stress Reduction (MBSR) teaches several different kinds of meditation. MBSR is offered as an online course through Duke Integrative Medicine and is based on the national model first developed by Jon Kabat-Zinn at the University of Massachusetts. It includes exercises in awareness of breath, body scans, walking meditation, choiceless open awareness, Loving Kindness Meditation, and bringing awareness to the present moment. The MBSR Distance Learning course consists of 8 weekly sessions via video conference and includes meditation instruction, periods of guided practice, and group discussion."
15778558|NCT04625777|Behavioral|Daily Examen spiritual practice|"The Daily Examen is a simple but powerful prayer used by Jesuits every day. It takes only 10-15 minutes and can be used to reflect on positive emotions, move past negative emotions, and align one's work with God's work. The Examen directs the person praying to focus on a five-step routine:
~Become aware of God's presence;
~Give thanks to God for everything in your life;
~Review the events of the day guided by the Holy Spirit;
~Look at what went well or wrong in the past day; if at fault, ask God for forgiveness; and
~Look toward tomorrow - what one thing should you do? Listen to what God is telling you."
15778559|NCT04625777|Behavioral|Stress inoculation combination|This intervention includes a combination of stress inoculation and general stress reduction activities focused on physiology, with exercises that bypass the brain and work directly on the body to mitigate the symptoms of stress. This system is based on Stress Inoculation Training, which uses breathing to prepare people in advance for stressful episodes and recovery skills for following such episodes. The techniques include a variety of breathing, blood flow, and tension control methods, as well as ways to conduct deep tissue massage on oneself to release muscle tension. The awareness aspect involves understanding stress biology and learning to spot the symptoms of stress in oneself and others.
15778560|NCT04625764|Procedure|Blood sampling and analysis|Blood sampling for pharmacokinetics (Plasma ticagrelor concentrations and its metabolite) and MEA platform testing (ADPtest, TRAPtest)
15778561|NCT04625751|Other|CO2-enriched air|To assess cardiovascular reactivity
15778562|NCT04625751|Other|Meal response test|Meal response test to assess changes in splanchnic blood flow.
15778563|NCT04625738|Biological|Ex vivo expanded Wharton's Jelly Mesenchymal Stem Cells|"Ex vivo expanded Wharton's Jelly derived mesenchymal stem cells will be infused at day 0, day 3 and day 5 (+/- 1 day), in patients with moderate to severe ARDS with a mechanical ventilation.
~day 0: 1.10^6 MSC/kg day 3: 0.5. 10^6 MSC/kg day 5: 0.5 . 10^6 MSC/kg"
15778564|NCT04625738|Biological|Placebo|Only the vehicle solution, without MSCs, containing albumin 4% , NaCl 0,9% and ACD will be injected to patients at day 0, 3 and 5 (+/-1 day).
15778565|NCT04625725|Drug|AZD7442|Single dose (× 2IM injections) of 300 mg of AZD7442 on Day 1.
15778566|NCT04625725|Drug|Placebo|Single dose (× 2IM injections) of saline placebo on Day 1.
15778567|NCT04625712|Procedure|Cholecystectomy|Cholecystectomy within the first week after a mild acute biliary pancreatitis
15778568|NCT04625699|Drug|Durvalumab|4 doses of Durvalumab 1500 mg IV Day 1, q28 days (For example, interventions involving drugs may include dosage form, dosage, frequency, and duration.)
15778569|NCT04625699|Drug|Tremelimumab|2 doses of Tremelimumab 300 mg IV Day 1, q56 days
15778570|NCT04625686|Behavioral|Mental Health Treatment|Treatment of suicidal ideation
15778571|NCT04625673|Device|OsciPulse|OsciPulse device and standard IPC device
15778572|NCT04625660|Device|PQ Bypass System|Intended use from CLN232 Rev A (CLN232 is the DETOUR2 Continued Access Protocol) The PQ Bypass System is intended to improve blood flow in patients with peripheral arterial disease in symptomatic femoropopliteal lesions due to chronic total occlusions ≥ 20 cm that can include de novo, restenotic, or in-stent restenotic lesions; or total lesion lengths ≥24 cm that can include chronic total occlusions or a ≥70% lesion that includes de novo, restenotic or in-stent restenosis.
15778574|NCT04625634|Other|2 days of work heat stress|2 consecutive days of identical simulated structural firefighting tasks.
15778575|NCT04625608|Drug|Paracetamol|Standard care of 3 ml/kg water, plus 15 mg/kg oral paracetamol suspension, a minimum of 1 hour prior to the induction of general anaesthesia.
15778576|NCT04625608|Other|Standard care|Standard care of 3.6 ml/kg water, a minimum of 1 hour prior to the induction of general anaesthesia.
15778577|NCT04625595|Drug|350mg BID (700mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsule|Oral drug or placebo self-administered by subject as a capsule by mouth once-daily or twice-daily
15778578|NCT04625595|Drug|700mg BID (1400mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsule|Oral drug or placebo self-administered by subject as a capsule by mouth once-daily or twice-daily
15778579|NCT04625595|Drug|1050mg QD (1050mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsule|Oral drug or placebo self-administered by subject as a capsule by mouth once-daily or twice-daily
15778580|NCT04625595|Drug|1050mg BID (2100mg total daily) IMT-002, D-methyldopa, active formulation in capsule or Placebo, microcrystalline cellulose in capsule|Oral drug or placebo self-administered by subject as a capsule by mouth once-daily or twice-daily
15778581|NCT04625582|Behavioral|Face-to-face|"The intervention has been created specifically for this group of trainees, with the aim of acquiring or improving mediating personal skills in the processes of physical and mental well-being that help them cope with more motivation, enthusiasm and personal resources professional challenges.
~It is based on conducting 4-hour face-to-face workshops, every four months throughout the period of specialized health training. They will be instrumented through group dynamics, communication exercises, leadership, corporality, and reflective and emotional writing.
~Audiovisual media (videos, presentations, recordings) will be used. They will be developed in person in a classroom equipped with the necessary means for training, including versatility of the space."
15778582|NCT04625582|Behavioral|Online|"The online intervention will pursue the same objectives and will be nourished by the same content as the face-to-face intervention. The theoretical content will be adapted for online use, with the flexibility of access and organization that this entails for the participants, including videos, presentations, recordings ...
~Group techniques will be carried out online, every four months during the entire period of specialized health professional training. They will be instrumented through group dynamics, communication exercises, leadership, corporality, and reflective and emotional writing."
15778583|NCT04625543|Drug|Sintilimab Injection plus Paclitaxel and Cisplatin|Paclitaxel 150mg/m2 on day 1, every 3 weeks, for two cycles; Cisplatin 70mg/m2 on day 1, every 3 weeks, for two cycles; Sintilimab Injection 200mg on day 22; 4-6 weeks after completion of preoperative therapy, Mckeown esophagectomy will be performed if there is no contraindication.
15778584|NCT04625543|Drug|Paclitaxel and Cisplatin|Paclitaxel 150mg/m2 on day 1, every 3 weeks, for two cycles; Cisplatin 70mg/m2 on day 1, every 3 weeks, for two cycles; 4-6 weeks after completion of preoperative therapy, Mckeown esophagectomy will be performed if there is no contraindication.
15778585|NCT04625530|Drug|ferric carboxymaltose|Ferric carboxymaltose 20 mg/kg (with a maximum dose of 1000 mg ferric carboxymaltose in a single Infusion) (Ferinject® 1000 mg/20ml, Vifor (International) AG, St. Gallen, Switzerland) will be diluted in 250 ml of 0.9% m/V sodium chloride solution and administered over 15 minutes intravenously between day -27 and day -7. The colour of ferric carboxymaltose is dark brown. A single Ferinject administration should not exceed 20 mg iron/kg body weight.
15778586|NCT04625530|Drug|tranexamic acid|Tranexamic acid 10mg/kg (Tranexam OrPha 1000 mg/10 ml, OrPha Swiss GmbH, Küsnacht, Switzerland) will be administered 15 -30 minutes prior to surgery followed by infusion of tranexamic acid through syringe pump (1 mg/kg/h) till 4 h postoperatively. The colour of the medicament is transparent.
15778587|NCT04625530|Drug|ferric carboxymaltose and tranexamic acid|Ferric carboxymaltose (Ferinject® 1000 mg/20 ml) will be administered between day -27 and day -7 and tranexamic acid (Tranexam OrPha 1000 mg/10 ml) 15-30 minutes prior to surgery followed by infusion of tranexamic acid through syringe pump (1 mg/kg/h) till 4 h postoperatively.
15778588|NCT04625517|Procedure|Digital Mammography|Digital Mammography enhanced with an iodinated contrast agent
15778589|NCT04625517|Drug|Low Osmolar Contrast Material, 300-399 Mg/Ml Iodine Concentration, Per Ml|Injection of low osmolar contrast material during the digital mammography exam
15778590|NCT04625504|Behavioral|Mindfulness Based Intervention|Standardized 8-week Cognitive and Behavioral Psychotherapy group with 26 hrs of in-class training and homework, along with 1 all-day retreat in which core mindfulness skills are developed
15778591|NCT04625491|Other|Observational|Observational
15778592|NCT04625478|Other|Patients having had an osteo-articular infection with Stahylococcus|Immunostaining targeting staphylococci and components will be performed on tissue samples collected from patients with osteo-articular infection
15778593|NCT04625465|Behavioral|CBT Text Messaging|Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order, with content equally distributed across the four content areas (i.e., psychoeducation regarding effects of stress, distress tolerance, emotion regulation, alcohol reduction).
15778594|NCT04625465|Behavioral|Attention Control Text Messaging|Over a 14 day period, participants will receive two text messages per day (one at 8 a.m. and one at 4 p.m.). They will receive hourly reminders for four hours or until the message is read. Participants receive the same messages in the same order. All texts will be supportive messages which express empathy and unconditional positive regard and provide support for dealing with stressors. These messages will be nondirective and will not include any CBT skill suggestions.
15778595|NCT04625452|Behavioral|BBCC+5A's+GS|"It is a 5-steps intervention delivered in a motivational interviewing spirit. Clearly the five steps are asking about the behaviour risk factors, assessing the level of risk factors; providing information about the pros and cons of the behaviour in a neutral way; assessing the change by probing about the importance in and the confidence of changing the risk factor; assisting the patient to come-up with a road map about changing the risk factor, connecting the patient to support networks or drugs which can increase the likelihood to change; and arranging for the next visit.
~All this given by asking opened question to participant, active listening, summarizing what he is saying, evoking change through concepts or statements, empathy and asking permission to provide further information."
15778596|NCT04625439|Behavioral|Personality Feedback Self-Management Intervention|The intervention is a personality feedback report that will tell participants whether they scored low (bottom third), average (middle third), or high (top third) on each of the five factor personality characteristics based on gender-matched norms. In addition to a description of general tendencies based on their level of each personality trait, the feedback will include information about how scoring in a given category may relate to an individual's cancer self-management or healthcare decision making. The feedback for each personality trait will include recommendations for how to improve key outcomes.
15778597|NCT04625426|Device|3M Cavilon No-Rinse Skin Cleanser and 3M Cavilon Advanced Skin Protectant|Hypoallergenic no-rinse skin cleanser and liquid acrylic tetrapolymer skin protectant
15778598|NCT04625426|Device|Conveen EasiCleanse and Conveen Critic Barrier|Hypoallergenic no-rinse skin cleanser and zinc-oxide barrier cream
15778599|NCT04625426|Device|Standard cleansing and Conveen Critic Barrier|Hospital's standard care for IAD management
15778600|NCT04625413|Behavioral|Behavioral: UR-GOAL communication tool|The UR-GOAL tool will incorporate conjoint analysis to elicit patient preferences as well as assessments of fitness and prognostic awarene
15778601|NCT04625400|Diagnostic Test|bronchoscope|Bronchoscopy in Assessment of Patients With Post-intubation Tracheal Stenosis.
15778602|NCT04625387|Other|Dry Needle and Exercise|"A 0.25 X 15 mm acupuncture needle was used for sub occipital muscle and 0.25 X 40 mm needle was used for paraspinal and trapezius muscle. All the necessary precautions were maintained before inserting the needle. Therapists wore hand gloves for all purposes.
~The exercise for the muscles of cervical group, for group A was carried out by elevating head from lying in supine position repeating 20 times in three sets and pressing a theraband forward in one set of 15 repetitions, to right side and to left side and back side"
15778603|NCT04625361|Drug|HEC122505MsOH|Part2：Mulltiple doses once daily, up to 8 days
15778604|NCT04625348|Device|Ultracore Repose® mattress|residents will be placed on the Ultracore Repose® mattress for the daily care during 14 days
15778605|NCT04625348|Other|experiences and perceptions of healthcare workers|Three focus groups will be set- up at the end of the study to provide insights into how caregivers think about the product and to provide a deeper understanding of the difference between the use of the Ultracore Repose® mattress (versus the Repose overlay mattress® and an alternating air mattress)
15778606|NCT04625335|Other|No Massage Protocol|Participants did not receive therapeutic massage prior to completing the Cold Pressor Test.
15778607|NCT04625335|Other|Prophylactic Therapeutic Massage|Participants received a 5 minute prophylactic therapeutic massage prior to completing the Cold Pressor Test. The massage was completed distally-to-proximally in the following order: superficial strokes to the entire forearm, deep strokes to the entire forearm, one-handed palmar kneading of the entire forearm with participant's forearm stabilized by the massager's the other hand, bilateral thumb kneading of the forearm in strips until the entire forearm was addressed, bilateral transverse thumb motions over palmar surface of the hand, single thumb kneading of thenar and hypothenar eminences simultaneously, bilateral thumb kneading to the dorsum of hand, deep stroking to the entire forearm, and superficial stroking to the entire forearm.
15778608|NCT04625322|Other|HCV care provided by hospitalist during acute psychiatric admission|HCV diagnosis and treatment will be conducted by a hospitalist during an acute psychiatric admission at CAMH
15778609|NCT04625309|Other|Adaptive sports|This will be the number of hours per week the subjects actively partake in adaptive sports teams.
15778610|NCT04625296|Behavioral|Semi-directive interview|Semi-directive interview, lasting a maximum of 45 minutes
15778611|NCT04625296|Behavioral|Questionnaire : Preparedness for Caregiving Scale|Preparedness for Caregiving Scale - 8 questions
15778612|NCT04625283|Drug|Ketamine|Participants in the ketamine arm will receive intraoperative and postoperative ketamine.
15778613|NCT04625283|Drug|Placebo|Participants in the placebo arm will receive intraoperative and postoperative saline.
15778616|NCT04625257|Other|Saliva based assay: crude RNA extraction|Crude RNA extraction to inactivate the virus and stabilize the RNA for transport at room temperature. Validation of the crude RNA extraction from saliva in combination with NGS diagnostics and LAMP assays and point of care test (POCT) for rapid detection of viral antigens on patients' samples.
15778617|NCT04625257|Other|Validation of the NGS method|Compare the results obtained with the next-generation sequencing (NGS) method to the nasopharyngeal swabs analysed in a FAMH certified lab.
15778618|NCT04625257|Other|Validation of the LAMP assays|The RNA will be analyzed onsite using the loop mediated amplification (LAMP) assay.
15778619|NCT04625257|Other|Validation of the POCT Antigen and Antibody tests|Rapid point of care tests (POCT) detecting viral protein antigens (Ag) and antibodies (Ab) on patients' samples. POCT are often employed in low income countries, but for COVID-19 they are not yet characterized. Their performance is to be characterized that they can be used as a safe guard if the lab diagnostics fail.
15778620|NCT04625244|Other|Video assisted home therapy|Subjects will follow along with prerecorded therapy videos.
15778621|NCT04625231|Behavioral|Educational Shared-Decision Making Tool|Patients received a short video presentation on pain management, use of over the counter medication, side effects of opioids and over-the-counter medications and ability to choose the amount of opioid pills up to the standard care amount.
15778622|NCT04625205|Biological|NEO-PTC-01|Administered via intravenous (IV) infusion.
15778623|NCT04625192|Procedure|Trephine osteotomy|"Using a trephine on a straight implant handpiece (at approximately 1800 rpm) with copious irrigation to avoid overheating the bone, a round bone cut will be made 4 -5 mm above the crest of the alveolar ridge.
~The trephine is positioned perpendicular to the lateral wall, removing the outer cortex with a very gentle touch to avoid tearing the schneiderian membrane."
15778624|NCT04625179|Other|Melatonin and hyaluronic acid and sinus membrane elevation|3 mg melatonin powder mixed with 0.2% hyaluronic acid gel will be placed to fill the sinus space and around the implant apex.
15778625|NCT04625179|Procedure|sinus membrane elevation without any materials|No materials will be placed at the sinus space.
15778626|NCT04625153|Biological|RC18 160mg|RC18 160mg is injected subcutaneously once a week for 48 times.
15778627|NCT04625153|Biological|RC18 240mg|RC18 240mg is injected subcutaneously once a week for 48 times.
15778628|NCT04625127|Device|Treadmill gait training with GaitBetter|Participants will receive gait training with the GaitBetter solution for a total of 15 sessions (3 days a week for 5 weeks) each lasting approximately 45 minutes.
15778629|NCT04625127|Other|Treadmill gait training with GaitBetter + Standard of care|Participants will receive gait training with the GaitBetter solution for a total of 15 sessions (3 days a week for 5 weeks) each lasting approximately 45 minutes. In addition, the investigators will record the number and duration of therapy sessions followed by the participant during standard of care.
15778630|NCT04625127|Other|Standard of care|Participants will follow their standard of care. The investigators will record the number and duration of therapy sessions followed during standard of care.
15778631|NCT04625114|Drug|Camostat|Standard of care (SOC) + Camostat mesilate (Foipan) 100mg 3 tablets 3 times a day for 5 consecutive days (D1->D5);
15778632|NCT04625114|Drug|Placebo|SOC + placebo 500 mg 3 tablets 3 times a day for five consecutive days (D1->D5).
15778633|NCT04625114|Drug|Camostat|Standard of care (SOC) + Camostat mesilate (Foipan) 100mg 3 tablets 3 times a day for 5 consecutive days (D6->D10);
15778634|NCT04625114|Drug|Placebo|SOC + placebo 500 mg 3 tablets 3 times a day for five consecutive days (D6->D10).
15778635|NCT04625101|Drug|NBI-827104|Triple T-type calcium channel blocker.
15778636|NCT04625101|Drug|Placebo|Non-active dosage form.
15778638|NCT04625088|Drug|Atropine + Standardized liquid test meal|During this study visit, 1.0 mg atropine will be administered I.V and then a standardized liquid test meal will be administered. Blood samples will be collected at baseline, following atropine administration, and then every 30 minutes for 4 hours after test meal.
15778639|NCT04625075|Diagnostic Test|Cardiac MRI|Cardiac MRI with gadolinium and manganese contrast
15778640|NCT04625075|Diagnostic Test|Cardiac CT|Cardiac CT to assess coronaries
15778641|NCT04625075|Diagnostic Test|Electrocardiogram (ECG)|ECG to assess rhythm
15778642|NCT04625075|Diagnostic Test|Blood samples|renal function liver function full blood count, hematocrit glucose
15778643|NCT04625062|Behavioral|Visual-acoustic biofeedback|In visual-acoustic biofeedback treatment, the elements of motor-based treatment (i.e., auditory models and verbal descriptions of articulator placement) are enhanced with a dynamic display of the speech signal in the form of the real-time LPC (Linear Predictive Coding) spectrum. Because correct vs incorrect productions of /r/ contrast acoustically in the frequency of the third formant (F3), participants will be cued to make their real-time LPC spectrum match a visual target characterized by a low F3 frequency. They will be encouraged to attend to the visual display while adjusting the placement of their articulators and observing how those adjustments impact F3. All treatment will be provided over video calls.
15778644|NCT04625062|Behavioral|Motor-based treatment|Motor-based articulation treatment involves providing auditory models and verbal descriptions of correct articulator placement, then cueing repetitive motor practice. Images and diagrams of the vocal tract will be used as visual aids; however, no real-time visual display of articulatory or acoustic information will be made available. All treatment will be provided over video calls.
15778645|NCT04625036|Diagnostic Test|Single passive leg movement|"The investigation consists of a non-invasive evaluation by ultrasounds performed on the common femoral artery investigating the speed of arterial blood flow [Leg Blood Flow LBF] and diameter of vessel with a dedicated ultrasound system (General Electric Medical Systems, Milwaukee, WI) using Doppler method, before and after a passive flexion-extension movement of the knee. A linear probe will be used with a frequency of 5 MHz. Using the diameter of the artery and the average volume (Vmean), the LBF will be calculated every second with the formula=Average volume*PiGreco*(vessel diameter / 2)2*60.
~The subject will be placed in a sitting position for 20 minutes before the test. The protocol consists of image acquisition for 60 seconds (basal measurement), followed by a passive flexion-extension of the knee (single passive leg movement). The knee flexion will be performed by health care personnel at a rate of 1 Hz. At the end of the movement, the recording will continue for 60 seconds."
15778646|NCT04625023|Other|Observational|Retrospective cohorts and Prospective observation of standard clinical practice
15778647|NCT04625010|Other|Swaddling|Swaddling is a wrapping procedure in which a baby's arms and legs are comfortable, sometimes only the arms are wrapped inside, and two ends of fabric are crossed on the chest of the baby, generally with thin cotton and soft fabric or a blanket. In the swaddling group, neonates were placed in the supine position on a blanket. In compliance with the newborn anatomic posture, the legs were wrapped in the flexion and abduction position. The arms of the neonates were placed close to their torso with both hands, without restraining limb movements. Swaddling was carried out 1 minute before the heel stich procedure and continued 3 minutes after the procedure. The neonate remained on the examination table during the swaddling procedure. Swaddling was applied not too loose or too tight during the procedure.
15778648|NCT04625010|Other|Maternal holding|Neonates in this group were held in their mothers' lap while their mothers were seated reclining on a comfortable chair. Neonates remained clothed in their mothers' lap during the heel stick procedure, and no breastfeeding was administered during the procedure. Holding was continued for a minimum of 3 minutes during and after the procedure.
15778649|NCT04624997|Other|biological sample|biological sample
15778650|NCT04624984|Drug|PD-1 inhibitor|PD-1 Inhibitor, intravenous drip, d1.
15778651|NCT04624984|Drug|PD-1 inhibitor, gemcitabine, vinorelbine and doxorubicin liposome|PD-1 Inhibitor, intravenous drip, d1; Gemcitabine, 1000mg/m2, intravenous drip, d1,d8; Vinorelbine, 50mg/m2, PO, d1,d8; Doxorubicin Liposome, 30mg/m2, intravenous drip, d1;
15778652|NCT04624958|Drug|Zanubrutinib and Rituximab|Zanubrutinb 160mg PO BID d1-28; Rituximab 375mg/m2 iv.drip d1.
15778653|NCT04624958|Drug|R-DHAOx|Rituximab 375mg/m2 iv.drip d1; Dexamethasone 20mg iv.drip d1-4; Cytarabine 2000mg/m2 (1000mg/m2 for patients aged over 65) iv.drip d2,3 Oxaliplatin 130mg/m2 iv.drip d1.
15778654|NCT04624958|Drug|Zanubrutinib Maintenance|Zanubrutinb 160mg PO BID.
15778655|NCT04624945|Diagnostic Test|APTT CWA (Activated partial thromboplastin time clot waveform analysis), Procalcitonin and Serological/Inflammatory markers (KL-6, SPA, MIG, Presepsin)|"Primary Aim: To validate the use of APTT CWA (Activated partial thromboplastin time clot waveform analysis) and ICIS (Intensive Care Infection Score), as early sepsis markers for neurosurgical ICU patients suffering subarachnoid haemorrhage, traumatic brain injury and other intracranial haemorrhages.
~Secondary Aim: To examine the evolution of CWA, immuno-parameters (KL-6, SP-A, MIG, presepsin) and various WBC (white blood cell count) activation markers over the time in relation to diagnosis of sepsis, development of positive blood cultures and mortality or recovery. Blood parameter measurements using a 3-part and 5-part differential analyser will be performed. KL-6, SP-A, MIG, presepsin are serum biomarkers - MIG (Monokine induced by gamma interferon), SP-A (Surfactant protein A), KL-6 (Krebs von den Lungen 6)."
15778656|NCT04624932|Behavioral|RR Digital Tool|This is the intervention condition. Participants in this condition will take the RR digital tool available at https://outsideplay.ca.
15778657|NCT04624932|Behavioral|Position Statement on Active Outdoor Play|This is the control condition. Participants in this condition will read the position statement that summarizes the issues and research regarding children's access to outdoor play.
15778658|NCT04624919|Other|Hot/Dry|Work is completed in a hot/dry environment.
15778659|NCT04624919|Other|Warm/Humid|Work is completed in a warm/humid environment
15778660|NCT04624906|Drug|Acalabrutinib|100 mg oral capsules twice daily for 1 year
15778661|NCT04624906|Drug|Bendamustine|90 mg/m2 on days 1 and 2 of each cycle.
15778662|NCT04624906|Drug|Rituximab|day 1 of each cycle (375 mg/m2 intravenously for the first cycle and 1400 mg subcutaneously OR 375 mg/m2 intravenously for subsequent cycles (as per institutional procedures).
15778663|NCT04624893|Drug|Polatuzumab Vedotin-Piiq|Patients will receive a total of six cycles of Pola in combination with rituximab and bendamustine or in combination with only rituximab. A cycle is typically 21 days for DLBCL.
15778665|NCT04624867|Drug|HP-1050 Patch|Both articles, HP-1050 and XULANE patch, will be applied simultaneously on the back of each subject.
15778666|NCT04624854|Drug|Clopidogrel and Aspirin dual-antiplatelet therapy|Patients will receive co-administration of clopidogrel and aspirin for 12 months after randomization.
15778667|NCT04624854|Drug|Aspirin monotherapy|Patients will receive aspirin monotherapy without co-administration of clopidogrel for 12 months after randomization.
15778668|NCT04624841|Drug|Indocyanine Green|2.5-7.5 mg (0.05 mg/kg) injection
15778669|NCT04624828|Procedure|Radiotherapy|"RT treatment Schedule as for clinical practice: Stereotactic body radiation treatment (SBRT) will be delivered with image guidance (image-guided radiation therapy or IGRT) and in the form of volumetric modulated arc therapy (VMAT).
~RT treatment Schedule: SBRT will be delivered in 1 to 6 fractions on bone or lymph node metastases. The dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints."
15778670|NCT04624828|Drug|androgen deprivation therapy (ADT)|"ADT as for clinical practice:
~for oligorecurrent patients, ADT will be started at time of polimetastatic progression after SBRT;
~for oligoprogressive patients, ADT will be continued during SBRT and untill polimetastatic progression"
15778671|NCT04624828|Biological|immune evaluation|We will use the flow cytometer FACSymphony, to analyse multiple immune populations from a limited sample of blood. We will monitor the dynamics of most innate (monocytic and granulocytic cells, Natural killer cells) and adaptive (T cells, B cells) immune subsets in the peripheral blood of PC patients before and after RT. We will deeply characterize CD4+ and CD8+ T cell subpopulations circulating in the patients enrolled in the study. In this attempt our panel will include markers of T cell differentiation and activation, including CD25, CD39, PD-1, CTL4, KLRG1, TIM3. We will analyse neutrophils subpopulations and investigate the functional profile of granulocytes in enrolled patients. Markers such as CD66b, CD24, CD16, MHC-II, LOX1, CD36 and CD62L will be included in our analysis. In conclusion our experimental strategy will result in a comprehensive profiling of the immune landscape in PC patients at single cell level.
15778672|NCT04624802|Behavioral|maternal exercise|The maternal exercise is broadly practiced by pregnant women in China. It is designed by a team led by Shen Shanmei, a professor of Maternity Exercises at Department of Obstetrics and Gynecology of First Hospital in Korea.
15778673|NCT04624776|Drug|Methylprednisolone|A dosis of 250 mg methylprednisolone is suspended in isotonic saline to a total volume of 4 mL prior to infusion.
15778674|NCT04624776|Drug|Isotonic saline|A bolus infusion of 4 mL isotonic saline (NaCl 0.9%).
15778675|NCT04624763|Procedure|Left bundle branch pacing|"LBBP is defined if fulfilling criterion 1 and at least one in criteria 2:
~Paced morphology of RBBD in surface lead V1 (QR, Qr, rSr', rSR' or Qrs);
~One of the following should be met:
~Selective LBBP with an iso-electrical window between the pacing spike and QRS onset;
~If using dual-lead method with one at His-bundle and the other at LBB region, a retrograde His-bundle potential is recorded from His-bundle lead during LBBP;
~LVATs at lead tip pacing of 1.5V/0.5ms and 10V/0.5ms are ≤ 80ms and the difference is < 10ms;
~A discrete LBB potential is recorded from lead tip and LVAT at tip pacing of 3V/0.5ms is ≤ 80ms19.
~If criterion 1 is fulfilled but none in criteria 2 is met, the procedure is considered to be left ventricular septal pacing (LVSP)."
15778676|NCT04624763|Procedure|Right ventricular pacing|Implantation of a RV pacing lead is attempted using the standard-of-care technique first.
15778677|NCT04624750|Drug|Mexiletine|"Patients will be enrolled sequentially into 2 cohorts. Cohort 1 - (patients aged 12 to < 18 years): approximately 8 weeks - 4 weeks of dose titration period + 4 weeks of maintenance period.
~Cohort 2 - (patients aged 6 to < 12 years,): approximately 8 weeks - 4 weeks of dose titration period + 4 weeks of maintenance period.
~Enrolment for Cohort 2 will begin after initial safety assessment of patients in Cohort 1 by the DSMB and no safety concerns are observed. The dose level for cohort 2 will be confirmed by PK modelling study."
15778678|NCT04624711|Drug|Eribulin Mesylate|Eribulin mesylate 1.4mg/m2, administered intravenously on Days 1 and 8 of each 21 day cycle.
15778679|NCT04624711|Drug|Anlotinib hydrochloride|Anlotinib 12mg, administered orally on Days 1-14 of each 21 day cycle.
15778680|NCT04624698|Device|iStent Inject Implantation|Subjects will be implanted with the iStent Injection Micro-Bypass device
15778681|NCT04624672|Drug|Semaglutide (1 Mg Dose)|Weekly injection of study drug for 4-6 months prior to Roux-en-Y gastric bypass surgery
15778682|NCT04624672|Drug|Placebo|Weekly injection of placebo for 4-6 months prior to Roux-en-Y gastric bypass surgery
15778683|NCT04624659|Drug|FT-4202 Tablets|200 mg once daily
15778684|NCT04624659|Drug|FT-4202 Tablets|400 mg once daily
15778685|NCT04624659|Drug|Placebo Tablets|Placebo once daily
15778686|NCT04624659|Drug|FT-4202 Tablets|Selected dose once daily
15778687|NCT04624633|Drug|Acalabrutinib|Oral, twice a day, predetermined dosage
15778688|NCT04624633|Drug|Umbralisib|Oral, once a day, predetermined dosage, each 28 day cycle up to 24 cycles
15778689|NCT04624633|Drug|Ublituximab|28 day cycle, starting cycle 7 via iv, on at predetermined dosage and timepoints in each cycle
15778691|NCT04624607|Device|Transspinal-transcortical paired-associative stimiulation combined with robotic gait training|Individuals with spinal cord injury will receive 20 daily sessions of robotic gait training. During assisted stepping, they will receive also paired non-invasive transspinal stimulation and non-invasive brain stimulation during the stance phase of gait. Before and after training standardized clinical and neurophysiological tests will be used to assess recovery of sensorimotor function.
15778692|NCT04624607|Device|Transcortical-transspinal paired-associative stimiulation combined with robotic gait training|Individuals with spinal cord injury will receive 20 daily sessions of robotic gait training. During assisted stepping, they will receive also paired non-invasive brain stimulation and non-invasive transspinal stimulation during the stance phase of gait. Before and after training standardized clinical and neurophysiological tests will be used to assess recovery of sensorimotor function.
15778693|NCT04624594|Other|Artificial Intelligence Feedback|AI mobile application provides feedback to participants randomized to artificial intelligence group.
15778694|NCT04624594|Other|Physical Therapist Feedback|PT provides feedback to participants randomized to physical therapist group.
15778695|NCT04624581|Device|Electrophysiological measurement of reflex nociceptive flexion threshold (RIII reflex) using Nicolet Vicking device|"This intervention measures the response to electrical stimulation of the sural nerve using a pair of percutaneous electrodes placed at the external malleolar retro passage of the nerve (2 cm apart) and connected to the stimulation device (Nicolet Vicking). Reflex muscle responses will be collected using surface electrodes placed on the femoral biceps muscle of the participant and connected to an Electromyogram recording device.
~The RIII will be determined twice (rest period between each 10-minute). In order to induce the reflex nociceptive flexion response, repeated cutaneous electrical stimulations (30 to 40) will be applied at the level of the sural nerve following a variable interval of 6 to 10 seconds in order to overcome the phenomena of habituation and predictability. Each stimulus test will consist of a single rectangular pulse of 0.5 ms, of variable intensity (0-100mA) until a reflex nociceptive flexion threshold is detected or a maximum current of 100 mA is reached"
15778696|NCT04624568|Device|PAPILOCARE|"Papilocare® is a self-administered vaginal gel. Its single-dose cannula contains hyaluronic acid and pre-biotics (Coriolus Versicolor) that would improve the re-epithelialization of the uterin cervix. By creating a protective film on the cervix, this gel could induce a favorable environment for regression of the cervical intraepithelial lesions 1 and for clearance of Human Papillomavirus.
~The specific approach related to our study would be to apply Papilocare® vaginal gel for 6 months for the treated group.
~Smear and HPV test will be perform by all patients at 6 and 12 months."
15778697|NCT04624542|Device|Electromyographic device|the EMG machine will be used to measure NCV of femoral nerve within individuals with PFPS
15778698|NCT04624529|Other|Self evaluation tool|This self-evaluation tool to evaluate cognitive function, developed by the occupational therapy department, is a paperwork task with guidelines for semi-structured interpretation.
15778699|NCT04624516|Other|self-structured foot exercise|The exercise was done 3 times a week (15x/until they tired x 2set). The exercise used a flexible band with difference thickness (0,5 mm in the first 12 weeks and 0,65 mm in the second 12 weeks)
15778700|NCT04624490|Drug|Hyperpolarized Xe129|During MRI scanning, subject will inhale hyperpolarized xenon gas for a maximum of 16 seconds per scan, with a maximum of 4 MR scans + Calibration in a given imaging session.
15778701|NCT04624464|Other|Rectal swabs - microbiological analysis|Microbial analyses will be performed from the rectal swabs obtained.
15778702|NCT04624464|Other|Examination of patient room|Only performed for cohort 2
15778703|NCT04624451|Drug|Dalbavancin|Dalbavancin 1500 mg intravenously x 1 dose
15778704|NCT04624438|Other|Isometric training with electromyostimulation|"Each training session (18 in total) consisted of forty 4-s contractions separated by 20 s inter-contraction intervals. The exercise intensity was close-to-identical among the sessions (60 %MVC). The force intensity was determined individually during pretest where EMS was delivered at maximal tolerable dose. Electrical stimulation was 6.25-second long and was followed by a rest period of 20-second (duty cycle 15%). Stimulation characteristics were selected among the Compex commercially available strength programs. The stimulation intensity was monitored on-line and determined by the subject at the start of each EMS session according to his/her pain threshold to produce a force corresponding to at least 60% of the pretest MVC score."
15778705|NCT04624438|Other|Isometric training with voluntary activation|Each training session (18 in total) consisted of forty 4-s contractions separated by 20 s inter-contraction intervals. The exercise intensity was close-to-identical among the sessions (60 %MVC). Participants were required to reach the proscribed force level only through voluntary activation of QF. To attain the same contraction/rest ratio as in EMS, automated audible signals were delivered in accordance with the contraction-rest pattern produced by the muscle stimulation device. To ensure participants produced 60% of individual MVC during each contraction the force level was measured with a force transducer and real-time feedback was provided on a computer screen.
15778706|NCT04624438|Other|Isometric training with combination of electromyostimulation and voluntary activation|Each training session (18 in total) consisted of forty 4-s contractions separated by 20 s inter-contraction intervals. The exercise intensity was close-to-identical among the sessions (60 %MVC). The proscribed force level was reached by the simultaneous action of EMS and VOLUNTARY. Each contraction was 6.25-second long and was followed by a rest period of 20-second (duty cycle 15%). Electrical stimulation corresponded to 30% of MVC, while the remaining 30% was achieved through voluntary muscle activation. To ensure participants produced a force corresponding to 60% of MVC during each contraction the force level was measured with a force transducer and real-time feedback was provided on a computer screen.
15778707|NCT04624425|Other|Segmental breathing exercises|Segmental breathing exercises along with the Conventional Treatment of buteyko breathing exercises for two weeks of duration. Segmental breathing exercises include 18-20 breaths in one session (6 breaths/min) with rest interval after every 6 breaths.
15778708|NCT04624425|Other|Buteyko breathing exercises|Buteyko exercises for two weeks of duration. Treatment session will be last for 10-15minutes.
15778709|NCT04624412|Other|Continuous Aerobic Moderate Intensity Exercise|"Continuous Aerobic Moderate Intensity Exercise
~5-10 min warm up
~30 min moderate aerobic exercise (Treadmill walking exercise)
~Constant intensity at 50% - 70% of max HR (3-6 METS)
~5-10 min cool down"
15778710|NCT04624412|Other|Continuous Aerobic (Mild intensity Exercise)|"Continuous Aerobic (Mild intensity Exercise)
~5-10 min warm up
~30 min mild aerobic exercise (Treadmill walking exercise)
~Constant intensity at 30-50 % of max HR (1-3 METS)
~5-10 min cool down"
15778711|NCT04624399|Drug|Atezolizumab|Patients receive 2 x 3-weekly cycles of Atezolizumab (one infusion on the first day of each cycle) prior to cystectomy surgery.
15778712|NCT04624386|Other|Thiol disulfide level|Venous blood is collected from all subjects and thiol disulfide levels will be determined from the serum samples obtained from the venous blood.
15778782|NCT04623866|Drug|Huaiqinhuang|Huaiqihuang granules are composed of Huaier fungus, Fructus lycii and Huangjing. Studies have shown that huaiqihuang treatment can reduce cytokines in children with purpura nephritis interleukins IL - 4, IL - 10 and the tumor necrosis factor alpha (TNF alpha) expression level, prompt huaiqihuang granule treating children allergic purpura nephritis can significantly improve the clinical curative effect, improve the level of cytokines and the patient's immune function, and does not increase the incidence of adverse reactions.
15778783|NCT04623866|Drug|valsartan|Valsartan granules 80mg/1.73m2 based qd 24 weeks
15778784|NCT04623853|Device|Variable Stiffness AFO|The Dynamic AFO is able to adjust in stiffness depending on activity.
15778713|NCT04624373|Other|Molecular analysis of surnatant|"The interventional pulmonologist selects the most suspect node. The corresponding TBNA is placed in Cytolyt and tagged using a sticker to indicate the specimen from which supernatant must be saved after the initial spin.
~The supernatant is transferred to the Laboratoire de Biologie Médicale Oncologique where it undergoes a further hard spin. The remaining supernatant is stored at -80°C before to send it to Foundation One for DNA extraction from 3 ml of supernatant and genotyping.
~Two 7,5 mL blood tubes are transferred to the laboratory to extract plasma. Plasma was stored at -80°C and then sent to Foundation One for DNA extraction from 2 mL of plasma and genotyping.
~10 slides from the cell block are shipped to Foundation One. These specimens are tested by FoundationOne®CDX (tissue), and FoundationOne®Liquid (supernatant and plasma) for genomic and TMB analyses (hybrid-capture based next generation sequencing)."
15778714|NCT04624360|Drug|Dexamethasone|Intravenous of Dexamethasone 8 mg post clamping of the umbilical cord
15778715|NCT04624360|Other|Placebo|2cc 0.9% Saline
15778716|NCT04624347|Behavioral|Access to video and movement curves|intervention of caregivers with access to videos and motion curves of the premature infant
15778717|NCT04624334|Other|Elektro-Entero-Graphy procedure|Fasting, after which pre- and postprandial EEnG measurements are performed.
15778718|NCT04624334|Other|EEnG Questionnaire|Filling out questionnaire about EEnG procedure.
15778719|NCT04624334|Other|Gold Standard Questionnaire|Filling out questionnaire about Gold Standard diagnostic used to diagnose colonic motility disorder.
15778720|NCT04624321|Behavioral|Health and lifestyle tool|Health and lifestyle tool used online
15778721|NCT04624321|Other|Usual care|Usual care at ordinary healthcare provider
15778722|NCT04624308|Drug|Toripalimab|Toripalimab 240mg d1，Q3W. Given with TPF during inductive chemotherapy and definitive radiotherapy.
15778723|NCT04624295|Drug|Early aspirin Therapy|Early Antiplatelet Therapy is administered within 24 to 48 hours after stroke onset and the dose is determined by the clinician. Aspirin was chosen for antiplatelet therapy.
15778724|NCT04624295|Drug|Non-Early aspirin Therapy|Antiplatelet therapy will be delayed to beyond 48 hours after stroke onset and may not be initiated until hemorrhagic Infarction has been confirmed absorbed.
15778725|NCT04624282|Diagnostic Test|different diseases|Patients will be divided into three groups, including chronic superficial gastritis ,chronic atrophic gastritis and gastric carcinoma.
15778726|NCT04624269|Drug|Hydroxychloroquine Sulfate Tablets|Hydroxychloroquine Sulfate Tablets ,0.1mg，bid po
15778727|NCT04624256|Procedure|Discussion|Patients and physicians engage in discussion
15778728|NCT04624256|Radiation|Hypofractionated Radiation Therapy|Undergo conventional hypofractionated radiation therapy
15778729|NCT04624256|Radiation|Hypofractionated Radiation Therapy|Undergo moderate hypofractionated radiation therapy
15778730|NCT04624256|Other|Laboratory Biomarker Analysis|Correlative studies
15778731|NCT04624256|Other|Quality-of-Life Assessment|Ancillary studies
15778732|NCT04624256|Other|Questionnaire Administration|Ancillary studies
15778733|NCT04624256|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15778739|NCT04624217|Drug|SHR-1701|PDL1/TGFβ
15778750|NCT04624191|Other|Saturation at home|Clinical benefit of taking saturation at home in interstitial lung disease
15778751|NCT04624178|Drug|Rucaparib|Rucaparib at 600 mg, orally, twice daily, continuously for 28 days.
15778752|NCT04624178|Drug|Nivolumab|Nivolumab 480mg intravenously on day 1 of every four-week cycle.
15778753|NCT04624165|Other|Survey|o We plan to hand out copies of a survey to examine patient's perspective on telemedicine.
15778754|NCT04624152|Behavioral|Soccer heading|A standardized and reliable soccer heading protocol will be used to induce subconcussive impacts for the experiment. A triaxial accelerometer (Triax Technologies, Norwalk, CT) embedded in a head-band pocket and positioned back of the head to monitor linear and rotational head accelerations. A JUGS soccer machine (JUGS Sports, Tualatin, OR) will be used to simulate a soccer throw-in with a standardized ball speed of 25 mph across all groups. The ball speed is similar to when soccer players make a long throw-in from the sideline to mid-field. Soccer players frequently perform this maneuver during practices and games. Participants will stand approximately 40ft away from the machine to perform the heading. Participants will perform a total of 10 headers at a rate of 1 header per minute and will be instructed to direct the ball back towards the JUGS machine. Previous uses of this soccer heading model have reported an average peak linear acceleration per header of 14.5 to 33.5 g.
15778847|NCT04623307|Diagnostic Test|Non-contact DCS-Speckle multi-parameter imaging|The protocol consists of 2-min resting, 6-min stationary state and 2-min resting, with monitoring data continuously by the DCS-Speckle.
15778755|NCT04624139|Behavioral|Internet-based cognitive behavioral therapy + physiotherapy|"Combined intervention of stress reducing I-CBT and physiotherapy. The intervention consists of two components; I-CBT and physiotherapy aiming to reduce symptoms of stress.
~I-CBT: Designed to reduce stress, during 8 weeks. Physiotherapy: A total of three visits with a physiotherapist (at start, after 4 weeks and after 12 weeks). Visit 1 (at start): The participant and the physiotherapist design together an individual plan of physical activity, based on the recommendations for stress as suggested in the Physical Activity in the Prevention and Treatment of Disease (FYSS in Swedish): Physical activity on moderate intensity 150 min/week and a strengthening exercise program performed at twice a week.
~The physical activity is performed outside health care - in the participant´s home or in other exercise premises outside health care Visit 2 and 3 (after 4 and 12 weeks): Follow up and revision of the Physical activity plan."
15778756|NCT04624139|Behavioral|Physiotherapy only|"A total of three visits with a physiotherapist (at start, after 4 weeks and after 12 weeks). Visit 1 (at start): The participant and the physiotherapist design together an individual plan of physical activity, based on the recommendations for stress as suggested in the Physical Activity in the Prevention and Treatment of Disease (FYSS in Swedish): Physical activity on moderate intensity 150 min/week and a strengthening exercise program performed at twice a week.
~The physical activity is performed outside health care - in the participant´s home or in other exercise premises outside health care Visit 2 and 3 (after 4 and 12 weeks): Follow up and revision of the Physical activity plan."
15778757|NCT04624126|Device|3D-Erect|3D-printed erectile device for intercourse
15778758|NCT04624113|Drug|Tazemetostat|Epizyme will supply the study agent, which will be provided free of charge to the patient.
15778759|NCT04624113|Drug|Pembrolizumab|Pembrolizumab is commercially available
15778760|NCT04624100|Procedure|Hernia repair|Primary or mesh repair of primary ventral or incisional hernia
15778761|NCT04624087|Behavioral|food-specific go/no-go computerized training|Participants will perform the computerized food specific go/no-go training a designated number of times over a four week duration (frequency varies by group). Each training session will last approximately 10 minutes and occur on different days of the week.
15778762|NCT04624087|Behavioral|nonfood-specific go/no-go computerized training|Participants will perform the computerized general go/no-go training 1 time per week over a four week duration. Each training session will last approximately 10 minutes and occur on different days of the week.
15778763|NCT04624074|Behavioral|Teen Marijuana Check Up|Teen Marijuana Checkup will be adapted for youth and young adults with first episode psychosis. The Teen Marijuana Checkup includes two intervention sessions. In Session 1, the interventionist uses motivational interviewing skills to hear the adolescent's history and current concerns with marijuana. The personalized feedback report generated from the baseline assessment is reviewed. In Session 2, the interventionist elicits change talk and guides discussion on making changes to reduce or stop marijuana use.
15778764|NCT04624061|Behavioral|Integrated HIV/HTN care model|The intervention is a multi-component intervention of combined HIV and HTN care, based on the PRECEDE framework, to continuously identify barriers and facilitators leads to better health outcomes including dual control of HIV/HTN among adults in HIV care in the intervention compared to control facilities
15778765|NCT04624048|Diagnostic Test|COVID-19 survey|Participants should complete a survey to analyze the impact of COVID-19 on University population.
15778766|NCT04624035|Procedure|Implantable Collamer Lens (ICL) in treatment of myopia in adults.|ICL Group: After mydriatic eye drops and topical anesthesia instillation, a 3-mm temporal corneal incision was done. Viscoelastic material was injected in the anterior chamber (AC). An injector cartridge (STAAR Surgical) was used to insert the ICL V4c model with central hole). The four footplates of the ICL were positioned on the ciliary sulcus at the 180° axis. Viscoelastic material was entirely taken away.
15778767|NCT04624035|Procedure|Implantable Intraocular Lens (IPCL) in treatment of myopia in adults.|IPCL Group: Topical anesthetic and mydriatic agents were instilled before surgery. Using peripulbar anaesthesia, the IPCL (V2 model with central hole) was implanted into the AC through a 3 mm clear corneal incision after viscoelastic material injection. The footplates were subsequently tucked behind the iris, followed by a thorough viscoelastic removal.
15778768|NCT04624022|Diagnostic Test|Anterior segment optical coherent tomography|Examination of the implanted perforated lacrimal plugs using anterior segment optical coherent tomography
15778770|NCT04623983|Device|bonding tray|Orthodontic bonding tray
15778771|NCT04623970|Procedure|Dental Treatment|Comprehensive dental care (restorative treatmen, crowns, pulp therapy, fissure sealant and teeth extraction for pediatric patients under the deep sedation
15778772|NCT04623957|Device|ForgTin©|"The device is clamped behind the ear via two connected temple parts that pressed together around the connecting axis until an individual perfect wearing comfort is achieved. The pressure is adjusted so that the wearing of ForgTin© is barely noticed at all and may be changed at any time.
~The aim is a slight pressure stimulation of clearly defined points behind the ear - thus wearing ForgTin© leads to a minimization of individual tinnitus noises."
15778773|NCT04623944|Biological|NKX101 - CAR NK cell therapy|NKX101 is an investigational allogeneic CAR NK product targeting NKG2D ligands on cancer cells. The starting dose of NKX101 in Part 1/Regimen A is 1 × 10^8 NK cells (2 × 10^6/kg for patients < 50 kg) administered as 3 weekly doses. The starting dose of NKX101 in Part 1/Regimen B is 1.5 × 10^8 NK cells (3 × 10^6/kg for patients < 50 kg) administered as 2 weekly doses. Part 2 will use the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of NKX101 as determined in Part 1.
15778774|NCT04623931|Other|Quality-of-Life Assessment|Ancillary studies
15778775|NCT04623931|Other|Questionnaire Administration|Ancillary studies
15778776|NCT04623931|Radiation|Radiation Therapy|Undergo radiation therapy
15778777|NCT04623931|Drug|Temozolomide|Given PO
15778778|NCT04623918|Other|Iron-biofortified rice|Iron-biofortified rice (IR68144-2B-2-2-3)
15778779|NCT04623918|Other|Control rice|Control rice (C4), identical in appearance
15778780|NCT04623892|Drug|TQB2618 injection|TQB2618 administered intravenously (IV) on Day 1 of each 21-day. The established dose of TQB2618 is diluted to 100 m with normal saline [0.9% (w/v) sodium chloride solution], and the infusion time is 60 ± 10 min.
15778781|NCT04623879|Drug|Lumacaftor, Ivacaftor Drug Combination|
15779088|NCT04621175|Dietary Supplement|EAA+W & Carbohydrate|Essential amino acid plus whey beverage with added carbohydrate
15778785|NCT04623840|Other|Tadalafil 5Mg Tab + continuous and interval exercise|(n=30) will be sedentary obese men with ED. All participants will receive five milligrams of tadalafil, one time per day, in addition to 3 sessions, per week, of combined continuous and interval aerobic exercise for eight weeks
15778786|NCT04623840|Drug|Tadalafil 5Mg Tab|(n=30) will be sedentary obese men with ED. All participants will receive five milligrams of tadalafil, one time per day, for eight weeks
15778787|NCT04623814|Other|Food|HEC113995 20mg will be taken orally fasted or with food
15778788|NCT04623814|Drug|HEC113995|HEC113995 will be taken orally fasted (HEC113995 10mg）or with food (HEC113995 20mg and 40mg） for 10 days
15778789|NCT04623814|Drug|placebo|The placebo will be administered fasted or with food for 10 days.
15778791|NCT04623788|Diagnostic Test|Cardiac MRI|Cardiac MRI with contrast
15778792|NCT04623775|Biological|Nivolumab|Specified dose on specified days
15778793|NCT04623775|Biological|Relatlimab|Specified dose on specified days
15778794|NCT04623775|Drug|Carboplatin|Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
15778795|NCT04623775|Drug|Cisplatin|Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
15778796|NCT04623775|Drug|Paclitaxel|Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
15778797|NCT04623775|Drug|Nab-Paclitaxel|Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
15778798|NCT04623775|Drug|Pemetrexed|Specified dose on specified days. Participant will receive only two of the listed chemotherapies (carboplatin, cisplatin, paclitaxel, nab-paclitaxel) along with immunotherapy.
15778799|NCT04623762|Other|Yoga|yoga application
15778800|NCT04623749|Procedure|US|Percutaneous Ultrasound guided FNAC
15778801|NCT04623749|Procedure|EUS|Endoscopic Ultrasound guided FNAC
15778802|NCT04623736|Behavioral|quitSTART|"All participants will have access to the Smokefree.gov Initiative smoking cessation smartphone application, quitSTART. This app is available, at no cost, to anyone who owns a smartphone and is interested in quitting smoking. All smokers who download quitSTART are asked to provide basic information about themselves (e.g., age, sex, reason to quit smoking, triggers to smoke, when users typically smoke, how users plan to celebrate success, smoking frequency, age when started smoking regularly, ethnicity, race, cigarettes smoked per day), and set a quit date. Information about cessation and challenges to help support quitting are available, as well as games and tracking features. While using the app, users can proactively report cigarette cravings, if they slipped, if they are feeling down or feeling great. If a user reports a craving, they have the option to mark the timing or location of the craving and request a reminder to resist future cravings at the same time or location."
15778803|NCT04623723|Other|PS (DS-016A, EMS® Piezon, Switzerland) scaler tips. )|Supragingival scaling with a portable ultrasonic scaler device (EMS®) with Piezon, Switzerland using PS (DS-016A, EMS® Piezon, Switzerland) scaler tips
15778804|NCT04623723|Other|Conventional (FS-407, EMS® Piezon, Switzerland)|Supragingival scaling with a portable ultrasonic scaler device (EMS®) with Piezon, Switzerland using Conventional (FS-407, EMS® Piezon, Switzerland)
15778805|NCT04623710|Drug|ALXN2050|ALXN2050 (120 milligrams) will be administered orally twice daily on Days 1 through 3, with an additional dose (120 milligrams) administered orally on the morning of Day 4.
15778806|NCT04623684|Drug|Microdrop administration [phenylephrine 1.67% + tropicamide 0.33% (drop volume: 6-7 μL)]|1 drop (6-7 μL) for 3 doses, 5 minutes' intervals
15778807|NCT04623684|Drug|Standard drop administration [phenylephrine 1.67% + tropicamide 0.33% (drop volume: 28-34 μL)]|1 drop (28-34 μL) for 3 doses, 5 minutes' intervals
15778808|NCT04623671|Biological|CAP-1002|100-mL (total volume) infusion of 150M CDCs in 5% Human Serum Albumin (HSA)
15778809|NCT04623671|Biological|Placebo|Matching placebo solution
15778810|NCT04623645|Device|ultrasound technique|evaluate the effect of ultrasound guided technique for block of internal branch of superior laryngeal nerve
15778811|NCT04623632|Drug|Transversus abdominus plane block|transversus abdominus plane block using 40 ml of bupivacaine 0.25%
15778812|NCT04623632|Drug|Transversus abdominus plane placebo|injection of 40 ml of normal saline in the transversus abdominus plane
15778813|NCT04623619|Dietary Supplement|Acetyl L-Carnitine|Administering 2 gr of Acetyl L-Carnitine orally in addition to the standard of care therapy for 14 days
15778814|NCT04623606|Biological|BOOST cells|Four doses of expanded human 1st trimester fetal liver-derived mesenchymal stem cells.
15778815|NCT04623593|Procedure|ACDF|Standard operative treatment for anterior cervical discectomy. Through a right or left-sided approach the disc space contents are resected. The endplates are prepared with curettes and the disc space contents are removed. The posterior longitudinal ligament is opened. The dura is visualized to ensure adequate decompression. A cage is implanted in the disc space. The disc removal and cage implantation can be performed at a single level or at multiple levels. The wound is closed in layers, after a prevertebral wound drain is placed.
15778816|NCT04623593|Procedure|ACDA|The start of the procedure is the same as in the ACDF group. After the discectomy, a cervical disc prosthesis is placed in the disc space instead of a cage, in accordance with the manufacturer's protocol for implantation and endplate preparation. The disc removal and arthrodesis implantation can be performed at a single level or at multiple levels. Wound closure is similar to the ACDF procedure.
15778817|NCT04623580|Device|Surgical inguinal or femoral hernia repair|Surgical inguinal or femoral hernia repair (primary or mesh)
15778818|NCT04623567|Drug|Jiangtang Tiaozhi recipe|The Jiangtang Tiaozhi recipe is a combination of several Chinese herbs, which has been granted a patent (No. ZL 2013 1 0373659.7)
15778819|NCT04623567|Drug|Metformin|The metformin tablets (500mg) will be administrated.
15778933|NCT04622501|Procedure|posterior spinal decompression and posterior spinal instrumented fusion|posterior spinal decompression and posterior spinal instrumented fusion performed on a patient with Spinal Epidural Lipomatosis
15778820|NCT04623554|Behavioral|Prehabilitation program|The prehabilitation program includes combined high-intensity interval training on a cycle ergometer and machine-based resistance exercise of large muscle groups supervised by a physiotherapist. Exercise sessions will take place in physiotherapy departments at local hospitals or in municipality rehabilitation centres 3 times a week during the neoadjuvant chemotherapy period and ending in the week before breast surgery (maximum estimated 29 weeks depending on number of chemotherapy cycles, dose delays and time of breast surgery). Participants will be screened for psychological distress four times and in case of moderate-severe distress be advised to visit the local Cancer Society Support Center where participants will be assessed and offered free services based on their psychosocial needs and available offers. Participation will be monitored.
15778821|NCT04623541|Biological|Epcoritamab|Epcoritamab will be administered in cycles of 28 days.
15778822|NCT04623528|Diagnostic Test|T1 and T2 relaxometry of the liver parenchyma|Evaluate T1 and T2 relaxomatry of the liver parenchyma to depict liver congestion in the different patient groups
15778823|NCT04623515|Other|REDCap Questionnaires|Once consent is obtained, the participants will be routed to a REDCap secure link. Participants will complete a questionnaires regarding demographics and medical history. Participants will also complete validated questionnaires regarding their lower urinary and bowel tract function and sexual health- International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ-FLUTS), Modified Manchester Health Questionnaire (MMHQ), PROMIS® v2.0 Brief Profile Sexual Function and Satisfaction (Female) and SF-12 ® .
15778824|NCT04623502|Other|13C-Glucose|Patients in the 13C-glucose arm will receive an infusion of a 13C-glucose solution. In most cases, the glucose infusion will be administered for 2-3 hours prior to resection of the mass. During the surgical procedure, 2-4mL of blood will be obtained approximately every 30 minutes to monitor blood glucose and/or blood pH. The infusion will be stopped after resection.
15778825|NCT04623502|Other|13C-Acetate|Patients in the 13C-acetate arm will receive an infusion of a 13C-acetate solution. In most cases, the acetate infusion will be administered for 2-3 hours prior to resection of the mass. During the surgical procedure, 2-4mL of blood will be obtained approximately every 30 minutes to monitor blood glucose and/or blood pH. The infusion will be stopped after resection.
15778826|NCT04623502|Other|13C-Lactate|Patients in the 13C-lactate arm will receive an infusion of a 13C-lactate solution. In most cases, the lactate infusion will be administered for 2-3 hours prior to resection of the mass. During the surgical procedure, 2-4mL of blood will be obtained approximately every 30 minutes to monitor blood glucose and/or blood pH. The infusion will be stopped after resection.
15778827|NCT04623502|Other|13C-Glutamine|Patients in the 13C-glutamine arm will receive an infusion of a 13C-glutamine solution. In most cases, the glutamine infusion will be administered for 2-3 hours prior to resection of the mass. During the surgical procedure, 2-4mL of blood will be obtained approximately every 30 minutes to monitor blood glucose and/or blood pH. The infusion will be stopped after resection.
15778828|NCT04623502|Other|13C-Fructose|Patients in the 13C-fructose arm will receive an infusion of a 13C-fructose solution. In most cases, the fructose infusion will be administered for 2-3 hours prior to resection of the mass. During the surgical procedure, 2-4mL of blood will be obtained approximately every 30 minutes to monitor blood glucose and/or blood pH. The infusion will be stopped after resection.
15778829|NCT04623489|Behavioral|¡Vivir Mi Vida! Lifestyle Intervention|
15778830|NCT04623476|Procedure|Pathophysiological Excision for Crohn's disease|Pathophysiological excision for Crohn's (PEC) requires a medio-lateral approach and a high vascular tie, which enables excision of lymph nodes draining the disease bowel. This procedure should not alter length of bowel resection and no additional risks are foreseen. A latero-lateral anastomosis will be fashioned following current guidelines.
15778831|NCT04623463|Behavioral|Physical activity intervention|Participants included in the present study will benefit from a 4-week physical activity intervention. Upon the initial visit, a physical activity prescription will be defined and they will be equipped with a physical activity monitor that allows feedback. Participants will then exercise one day per week on-site and 4 days/week on their own. Weekly physical activity will be reviewed weekly with the participant during their on-site visit.
15778832|NCT04623450|Other|Smoothie|Preload smoothies that are matched for taste, smell, appearance, quantity and calorie but different caloric content.
15778833|NCT04623424|Diagnostic Test|intestinal microbiota|Stoll samples will be tested for different bacteria
15778834|NCT04623411|Behavioral|Neonatal resuscitation training with classical method and serious game simulation method|"After the theoretical training, the participants will be given technical information on the use of web-based neonatal resuscitation serious game simulation method.
~Each participant will be asked to apply this method at least three times."
15778835|NCT04623411|Behavioral|Control Group|Neonatal resuscitation training with classical method
15778836|NCT04623398|Drug|Lithium Carbonate|The experimental drugs in this study will be lithium carbonate capsules dosed at 62.5mg, 125mg and 250mg prepared as hospital preparations for clinical trials.
15778837|NCT04623398|Drug|Placebo|Placebo
15778838|NCT04623385|Combination Product|Aerosolized 13 cis retinoic acid plus Inhalation Inhaled testosterone|"The infected patients will receive Aerosolized 13 cis retinoic acid in gradual in 2 divided doses increases froms 0.2 mg/kg/day to 4 mg/kg/day as inhaled 13 cis retinoic acid therapy for 14 days
~The infected patients will be treated with a single dose of testosterone (0.1, 0.2, or 0.3 mg) by inhalation for 14 days"
15778839|NCT04623385|Drug|The standard therapy|infected patients will receive the standard therapy for COVID-19 for 14 days
15778840|NCT04623372|Procedure|suture|suture by separated knots using a non-absorbable 4.0 wire and application of a dry dressing after the punch skin-biopsy
15778841|NCT04623372|Procedure|directed wound healing|application of a dry dressing without any prior suture after the skin biopsy.
15778842|NCT04623359|Device|High resolution manometry|High resolution manometry
15778843|NCT04623346|Procedure|Observation for study group|Patients with Weber B-type Ankle fractures, extraarticular wrist fractures and proximal humerus fractures were followed with conservative manner( cast or sling)
15778844|NCT04623333|Drug|TQB2450|TQB2450 1200mg administered intravenously (IV) on Day 1 of each 21-day cycle.
15778845|NCT04623320|Diagnostic Test|euglycaemic clamp test|clamp test (golden standard) to determine insulin resistance
15778846|NCT04623320|Diagnostic Test|13C glucose breath test|13C glucose breath test to compare with the golden standard
15778848|NCT04623294|Procedure|Oxygen supply of high-low-high procedure|"The protocol consisted of 1-hour resting, 3-minute baseline measurement, half-hour measurement at 60% FIO2(phase I, high oxygen), half-hour measurement at 40% FIO2 (phase II, low oxygen) and half-hour measurement at 60% FIO2 (phase III, high oxygen).
~Device: Optical monitor for hemodynamic parameter. Near infrared spectroscopy instrument was attached on the subjects' forehead to detect the changes of hemodynamic parameters."
15778849|NCT04623294|Procedure|Oxygen supply of low-high-low procedure|"The protocol consisted of 1- hour resting, 3-minute baseline measurement, half-hour measurement at 40% FIO2 (phase I, low oxygen), half-hour measurement at 60% FIO2 (phase II, high oxygen) and half-hour measurement at 40% FIO2 (phase III, low oxygen).
~Device: Optical monitor for hemodynamic parameter. Near infrared spectroscopy instrument was attached on the subjects' forehead to detect the changes of hemodynamic parameters."
15778850|NCT04623281|Device|Sixty device|Prototype wearable hydration monitor to be worn by patient during dialysis and at night
15778851|NCT04623268|Diagnostic Test|Ultrasound and questionnaire|One invititation to identified adult offspring to have an ultrasound to detect an AAA. The prevalence in this Group (strata for sex) will be compared to a random selected matched Control group
15778852|NCT04623255|Drug|OCTAPLAS|plasma exchange
15778853|NCT04623242|Drug|Gantenerumab|Subcutaneously every 4 weeks at escalating doses
15778854|NCT04623242|Drug|Solanezumab|Intravenous infusion every 4 weeks at escalating doses
15778855|NCT04623242|Drug|Matching Placebo (Gantenerumab)|Subcutaneous injection of placebo every 4 weeks
15778856|NCT04623242|Drug|Matching Placebo (Solanezumab)|Intravenous infusion of placebo every 4 weeks
15778857|NCT04623229|Procedure|MCS|Manual Cataract Surgery
15778858|NCT04623229|Procedure|ReLACS Early|ReLACS with early administration of anesthesia
15778859|NCT04623229|Procedure|ReLACS Standard|ReLACS with standard time administration of anesthesia
15778860|NCT04623216|Biological|Sabatolimab|Sabatolimab is a solution in vial for IV infusion
15778861|NCT04623216|Drug|Azacitidine|Azacitidine comes in Vial for IV infusion or subcutaneous administration
15778862|NCT04623203|Other|No intervention|No intervention
15778863|NCT04623190|Behavioral|Wait-List Control|-Will receive routine clinical care. After completion of follow-up measures, control participants will receive a behavior change prescription via the PREVENT tool
15778864|NCT04623190|Behavioral|PREVENT tool|-PREVENT is a novel Health Information Technology tool designed to promote physical activity and healthy food intake among overweight/obese patients at the point of care. PREVENT automates the delivery of personalized, evidence-based behavior change recommendations and provides an interactive map of community resources to help providers link patients to resources in their community.
15778865|NCT04623164|Drug|Cocktail from complex phytoadaptogens (CFA)|Cocktail from complex phytoadaptogens (CFA) is composed from 70% alcohol extracts of Glycyrrhiza glabra, Rhodiola rosea, Acantopanax senticosus in the ratio 2:1:1. Application of CFA in 3 group was carried out after non-surgical periodontal therapy (NSPT). After NSPT the patient filled out an Estberg questionnaire to determine the chronotype. After processing the questionnaire, a chronotype was identified and the patient was prescribed CFA dosage. Application of CFA was carried out in the periods of exacerbation of chronic periodontitis within 28 days with a dosage of CFA depending on the chronotype of the person - morning chronotype at 45 drops in the morning before 10.00 o'clock; independent chronotype 20 drops 3 times a day; evening chronotype 30 drops at 14.00 o'clock and 20 drops at 19.00 o'clock.
15778866|NCT04623164|Procedure|Standard non-surgical periodontal treatment (NSPT)|Oral hygiene instructions (including brushing technique, the use of interdentally flosses, and/or brushes), NSPT (mouth scaling and root planing using an ultrasonic scaler UDS-L LED (Woodpecker, China) and Graceys curettes (Hu Friedy, Chicago, USA)). The treated periodontal pockets were irrigated with 0.12% chlorhexidine gluconate. Patients were given recommendation to rinse their mouth three times daily for 14 days using 0.12% chlorhexidine gluconate
15778867|NCT04623151|Behavioral|Online leaflet about foot care|Short text-based leaflet about foot care, presented online
15778868|NCT04623125|Behavioral|Spaced Retrieval Practice|Online picture-naming training with 60 words which the participant experiences word-retrieval difficulties. Cards are shuffled arranged by the computerized training program.
15778869|NCT04623112|Device|Hearing aid feature: Frequency Compression|FC Deactivated/Activated & set to default/Activated & set to hearing loss
15778870|NCT04623099|Drug|Escitalopram|Escitalopram is FDA-approved for the treatment of major depressive disorder (MDD) in adolescents (12-17 years of age) and is commonly prescribed for adolescents with anxiety disorders.
15778871|NCT04623086|Drug|Insulin Degludec|Insulin Degludec injection
15778872|NCT04623086|Drug|Insulin Glargine|Insulin Glargine injection
15778873|NCT04623086|Drug|Placebo|9g/L sodium chloride (normal saline) subcutaneous injection manufactured to mimic insulin glargine injection
15778874|NCT04623073|Procedure|Total Hip arthroplasty via a Direct Anterior Approach|Total Hip arthroplasty via a Direct Anterior Approach
15778875|NCT04623060|Other|Combination of Low-volume interval treadmill training and Resistance Training|"Low-volume interval training (LV-ITT) protocols included a 5 min warm-up (30%-50%VO2peak) up to 20min of LV-ITT and a 5 min cooling down (30%-50% VO2peak). The LV-ITT will repeat 60s bursts of fast treadmill walking at maximum tolerate speed (0% incline), alternate with pre-specified recovery periods about 4 minutes according to protocol. Each time the participants completed a burst successfully, treadmill speed will be increased by 0.1 mph for the next burst. The recovery periods will be 4 minutes. The intervention will be conducted for about 30 minutes.
~Resistance training will be conducted by using a horizontal leg press machine. They are encouraged to focus on an explosive concentric movement and a controlled eccentric movement such that the time on each phase was in the ratio 1:2."
15778876|NCT04623034|Drug|Ademetionine|
15778877|NCT04623021|Drug|Nafamostat Mesilate|Administered intravenously as a continuous infusion
15778878|NCT04623008|Behavioral|Goal-Oriented Episodic Future Thinking|Individuals in the intervention group will receive a 20-week web-based intervention and individual health coaching focused on stress management, healthy eating and physical activity.
15778879|NCT04622995|Drug|Benzodiazepine|Benzodiazepine prescribing
15778934|NCT04622488|Drug|Diclofenac Potassium|- In the form of Insitu gel system can be applied as solution or suspension that undergoes gelation after administration. Applied once inside the root canal after chemo-mechanical preparation.
15778880|NCT04622982|Other|Multidisciplinary treatment of obesity (diet + vitamin D + exercise + psychotherapy)|"Body weight reduction was induced by a low-energy mixed diet (55 % carbohydrates, 30 % lipids and 15 % proteins) providing 600 kcal less than individually estimated energy requirements based on the measured REE. The energy content and macronutrient composition of the diets adhered to the nutritional recommendations of the American Diabetes Association.
~Patients were administered vitamin D supplement only if they presented a value of 25-hydroxyvitamin D (25OHD) <30 ng/ml in blood tests at the beginning.
~Patients were following an individualized physical activity plan within the hospital and were aided by a psychodynamic approach therapist."
15778881|NCT04622969|Behavioral|Healthy Child Development Program|The Healthy Child Development Program is a family-based intervention focused on strengthening positive behaviors in children, managing misbehavior, and addressing healthy lifestyle choices.
15778882|NCT04622956|Drug|Methotrexate Injectable Solution|"Phase 1:
~Level -1: Methotrexate 7.5 mg/m2 on D+6 and D+9*. Level -1 will be explored only if the starting dose is too toxic (reduced dose).
~Level 0 [Starting Dose]: Methotrexate 10 mg/m2 on D+6 and 7.5 mg/m2 on D+9
~Level +1: Methotrexate 10 mg/m2 on D+6 and D+9
~Level +2: Methotrexate 15 mg/m2 on D+6 and 10 mg/m2 on D+9
~Phase 2: dose determined in the phase 1 trial"
15778883|NCT04622943|Behavioral|firearms safety|interactive and engaging website with videos and educational games to teach children firearms, hunting and shooting safety
15778884|NCT04622943|Behavioral|nutrition|interactive and engaging website with videos and educational games to teach children about nutrition and exercise
15778885|NCT04622930|Device|Smartphone-delivered CBT for SAD|12-week Smartphone-delivered CBT for SAD. In-person cognitive-behavioral therapy (CBT) is an empirically supported treatment for SAD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., exposure with ritual prevention), and perceptual retraining/mindfulness skills.
15778886|NCT04622917|Drug|MethylPREDNISolone 40 Mg/mL Injectable Suspension|intramuscular injection
15778887|NCT04622917|Drug|NaCl 9 MG/ML Injectable Solution|Intramuscular injection
15778888|NCT04622904|Drug|lidocaine-magnesium infusion|A bolus dose of lidocaine of 1.5 mg/kg will be administered within 10 minutes preoperatively diluted in 100 mL of saline. Then, 3 mg/kg/h of lidocaine will be administered intraoperatively. A bolus dose of ketamine of 0.35 mg/kg will be administered within 10 minutes preoperatively diluted in 100 mL of saline. Followingly, 0.2 mg/kg/h of ketamine will be administered intraoperatively diluted in a 50 mL syringe and administered at a rate of 20 mL/h
15778889|NCT04622904|Drug|lidocaine-ketamine infusion|A bolus dose of lidocaine of 1.5 mg/kg will be administered within 10 minutes preoperatively diluted in 100 mL of saline. Then, 3 mg/kg/h of lidocaine will be administered intraoperatively. A bolus dose of magnesium of 50 mg/kg will be administered within 10 minutes preoperatively diluted in 100 mL of saline. Followingly, 10 mg/kg/h of magnesium will be administered intraoperatively diluted in a 50 mL syringe and administered at a rate of 20 mL/h
15778890|NCT04622904|Drug|lidocaine infusion|A bolus dose of lidocaine of 1.5 mg/kg will be administered within 10 minutes preoperatively diluted in 100 mL of saline. Then, 3 mg/kg/h of lidocaine will be administered intraoperatively. A bolus dose of normal saline 100 mL will be administered preoperatively within 10 minutes. Followingly, normal saline will be administered intraoperatively at a rate of 20 mL/h
15778891|NCT04622891|Drug|Clarithromycin 500mg|clarithromycin 500
15778892|NCT04622891|Drug|Azithromycin|azithromycin group
15778893|NCT04622891|Drug|Placebo|control group
15778894|NCT04622878|Procedure|thrombectomy and PTA|open femoral access with fogarty catheter then PTA with balloon and possible stenting if needed
15778895|NCT04622865|Drug|Masitinib|Masitinib is a small molecule drug that selectively inhibits specific tyrosine kinases such as colony-stimulating factor 1 receptor (CSF1R), c-Kit, LYN, FYN, and platelet-derived growth factor receptor (PDGFR) α and β, in the submicromolar range.
15778896|NCT04622865|Drug|Isoquercetin|Isoquercetin is a flavonoid, derivative of quercetin. Isoquercetin is rapidly hydrolyzed to quercetin.
15778897|NCT04622865|Drug|Best Supportive Care|Best Supportive Care is best available therapy at the choice of the investigator, including, but not limited to, oxygenation, analgesics, anti-thrombotics, anti-viral drugs or biologics drugs.
15778898|NCT04622852|Device|Open reduction internal fixation (ORIF) with an angular stable plate|Operative treatment of proximal humeral fracture
15778899|NCT04622839|Other|Tylenol and NSAIDS (Ibuprofen, diclofenac)|"This study will assess an aspect of perioperative care relating to pain control. Subjects will not be aware of which aspect is randomized, but will be given a list of possible aspects which will include the intervention (listed below):
~Agents used in nerve block (lidocaine vs ropivacaine)
~Location of injection for analgesic
~Use of over-the-counter pain management (including but not limited to acetaminophen, ibuprofen, naproxen, etc.)
~Type of initial opioid prescribed (including but not limited to oxycodone, tramadol, hydrocodone, etc.)
~Number of pills in the initial opioid prescription
~Instructions for sling wear (duration of use or type of sling)
~Ice usage (duration of use and frequency of use)
~Blinding the participant to the randomized aspect of this study will help prevent bias in patient responses for outcome scores and medication usage."
15778900|NCT04622826|Biological|immune plasma|immune covid 19 plasma infusion
15778901|NCT04622813|Drug|nefopam, ketoprofen, paracetamol|Patients in this group will receive Nefopam and Ketoprofen in addition to the paracetamol intraoperatively prior to the anticipated end of the surgery
15778902|NCT04622813|Drug|saline infusion, ketoprofen, paracetamol|Patients in this group will receive one placebo infusion (saline infusion) in addition to the ketoprofen and paracetamol intraoperatively prior to the anticipated end of the surgery
15778903|NCT04622800|Other|Exercise, proprioceptive neuromuscular fasilition (PNF) techniques|PNF applications are defined as the autogenous inhibition, reciprocal inhibition, stress relaxation and gate control theory. Anterior elevation / posterior depression will be performed in the form of repetitive contractions using anterior depression / posterior elevation patterns. There will be 10 repetitions, with a 2-minute rest break between each technique. The treatment will continue twice a week for a total of 6 weeks.
15778931|NCT04622514|Other|People-centered integrated care|1. Reorienting the model of care: using of telemedicine platform and online consulting clinic; 2. Coordinating services: contract service by village doctor and on-line AF specialist; 3. Empowering and engaging people: provide village doctor ABC pathway training course; regular visit and drug delivery by village doctor (community support); patients and their family members education.
15778904|NCT04622787|Other|Knowledge translation|"A. Healthcare Providers Observational Study - measure of the effectiveness of the International Guidelines training courses (face to face and online) delivered to medical professionals (involves all clinical partners).
~The International Guidelines training courses on the evidence-based principles of Early Detection (ED), Early surveillance (ES), and Early intervention (EI) will be delivered to healthcare providers.
~Face-to-face professional trainings will be set up at each Consortium partner location. E-learning platform will allow for training and follow-up resources will be available to clinicians in all languages that are spoken/written in the locations of the Consortium partners.
~Clinicians will be assessed on their knowledge and standard clinical practices in survey format before trainings and after the trainings."
15778905|NCT04622774|Drug|IMGC936|Antibody Drug Conjugate
15778906|NCT04622761|Drug|Cabazitaxel|"Patients will receive Cabazitaxel 25 mg/m2 * intravenously over one hour every 21 days (on Day 1 of each cycle). Treatment will be continued for 4 cycles unless disease progression, unacceptable toxicity or patient request. These patients will have surgery (radical prostatectomy) 4-86 weeks following treatment.
~*Cabazitaxel dose should be capped at 50mg (BSA=2)"
15778907|NCT04622748|Behavioral|Trier Social Stress Test|8-min oral calculation and 5-min speech
15778908|NCT04622735|Combination Product|nefopam hydrochloride 30mg / paracetamol 500mg X2|The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
15778909|NCT04622735|Drug|Paracetamol 500 Mg Oral Tablet X2|The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
15778910|NCT04622735|Drug|Nefopam HCl 30 MG Oral Tablet X2|The first intake is taken right after randomization. Then on-demand period (5 days maximum) respecting a 6-hour interval between intakes, and up to 3 intakes per day.
15778911|NCT04622722|Other|Nutren Diabetes|Nutren Diabetes provides energy at 360 kcal per 360 ml
15778912|NCT04622722|Other|Isocaloric|Isocaloric diet One carton of soy milk (250 ml) and bologna sandwiches (two slices of bread) with mayonnaise
15778913|NCT04622709|Drug|Furosemide (loop diuretic) Tablets|Open label dose escalation study of furosemide in people receiving maintenance hemodialysis. Participants will take furosemide oral tablets twice daily for 18 weeks. Doses will be titrated every 2 weeks for 6 weeks if safe, effective, tolerated, and accepted by the participant. First 2 weeks of the study: participants not taking oral furosemide at enrollment will take 80mg furosemide twice daily, those taking oral furosemide at enrollment will stay on their prescribed dose, and those taking another loop diuretic at enrollment will discontinue their prescription and take an equivalent oral furosemide dose. At week 4: dose escalation if tolerated (from 80mg to 120mg twice daily for the 1st group, and a 50% increased dose not >320mg/day for the 2nd & 3rd groups). At week 6: dose escalation if tolerated (from 120mg to 160mg twice daily for the 1st group, and a 50% increased dose not >320mg/day for the 2nd & 3rd groups). Final 12 weeks: all participants will take the maximum tolerated dose.
15778914|NCT04622696|Diagnostic Test|Ultrasound imaging|Subjects in the performance cohort will undergo ultrasound imaging to assess the visibility of the HydroMARK Breast Biopsy Marker at 6-12 weeks post-implant. There is no intervention in the safety cohort (retrospective chart review).
15778915|NCT04622683|Procedure|Ultrasound|To determine whether ultrasound exposure at the porta hepatis will affect plasma glucose levels. To also determine whether porta hepatic ultrasound exposure will affect plasma glucose levels as well as insulin sensitivity among overweight/obese individuals who have normal glucose tolerance or impaired glucose tolerance (as defined by OGTT.
15778916|NCT04622670|Other|Media Intervention|Receive DVD
15778917|NCT04622670|Other|Quality-of-Life Assessment|Ancillary studies
15778918|NCT04622670|Other|Questionnaire Administration|Ancillary studies
15778919|NCT04622670|Other|Survey Administration|Ancillary studies
15778920|NCT04622670|Procedure|Yoga|Attend yoga class
15778921|NCT04622657|Other|dubousset functional test|Dubousset Function Test, 3-m backwards walk test, timed up and go test,Tinnetti Balance and Gait Test, Berg BalanceTest, Functional Reach Test
15778922|NCT04622644|Device|Device: clinical investigation microwave device class IIa not marked CE for stroke detection|Patients with hyperacute stroke are referred to the emergency room with a 'stroke code'. Clinical collected data includes NIHSS and mRS. Patients will undergo to NCCT in order to exclude the haemorragic nature of vascular disease. In the same diagnostic session the patient undergo to CTA with tri-phase protocol to assess LVO. Before starting the CTA acquisition with iodinate contrast injection the StrokeWave will be placed on the head of the patients in the CT room passing toward the gantry of the CT avoiding any loose of time. The scanning with the StrokeWave will be performed in about 5 minutes and the system will be removed allowing the CTA acquisition.
15778923|NCT04622618|Drug|Gabapentin|Anticonvulsant, Antiemetic, Analgesic
15778924|NCT04622605|Device|Trabecular bypass and Schlemm's canal stent|ab interno Microstent placement after cataract surgery
15778925|NCT04622592|Biological|Instramuscular vaccine|On Day 0, subjects will receive one intramuscular (IM) injection into the deltoid region of the non-dominant (if possible) arm.
15778926|NCT04622579|Drug|lenalidomide combined with rituximab|lenalidomide and rituximab are dilivered as described, parameters concerning efficacy and safety are also obtained.
15778927|NCT04622566|Drug|Lenvatinib, Pembrolizumab|After enrollment, patients receive pembrolizumab 200 mg via IV infusion on Day 1 of each 3-week cycle for 6 weeks; Lenvatinib 20mg orally once daily for 6 weeks. Patients conduct surgery within 1-4 weeks after the last dose of Pembrolizumab and Lenvatinib. After complete surgery, Pembrolizumab will be as adjuvant treatment for up to 15 cycles, 200mg IV on day 1 of every 21 day-cycles.
15778928|NCT04622553|Drug|Mexiletine|"Patients will be enrolled sequentially into 2 cohorts.
~Cohort 1 - (patients aged 12 to < 18 years):
~approximately 8 weeks - 4 weeks of dose titration period + 4 weeks of maintenance period.
~Cohort 2- (patients aged 6 to < 12 years,):
~approximately 8 weeks - 4 weeks of dose titration period + 4 weeks of maintenance period. Enrolment for Cohort 2 will begin after initial pharmacokinetics (PK), safety and efficacy are confirmed in this population, of patients in Cohort 1"
15778929|NCT04622540|Procedure|External biliary drainage|Application of external biliary drainage through duct-to-duct anastomosis
15778930|NCT04622527|Other|Random assigned paradigm viewing order|Participants experience the paradigm in a random order
15778932|NCT04622514|Other|Usual care|Routine outpatient clinic by AF specialist
15778935|NCT04622475|Biological|Fecal Microbiota Transplant (FMT) Capsule|When enrolled in the study, subjects will ingest 20 FMT capsules/day orally for 3 consecutive days. If the syndrome is not completely recovered or relapse 14 days after the first administration, the subject will receive a booster dose (20 capsules/day for 3 consecutive days).
15778936|NCT04622462|Procedure|Standard of Care Histopathology|Assessment for mild, moderate, or severe dysplasia, and risk of progression to oral cancer
15778937|NCT04622462|Procedure|STRATICYTE Assessment|Assessment for risk of progression to oral cancer
15778938|NCT04622423|Other|Observational study|Biobanking of biospecimens; clinical follow-up; biological analyses on biospecimens; collection of clinical, molecular, genetic and immunological data.
15778939|NCT04622397|Drug|Tranexamic acid injection|Local subfascial and intramuscular infiltration will be performed by surgeon at levels of fixation prior to skine incision
15778940|NCT04622397|Drug|Saline|Local subfascial and intramuscular infiltration will be performed by surgeon at levels of fixation prior to skine incision
15778941|NCT04622384|Other|Dialysis weaning|Dialysis weaning as planned by the attending ICU-physician.
15778942|NCT04622371|Other|Moderate exercises|Group 1 received 30 minutes of aerobic exercise at 40-60% of maximum heart rate. Group 2,Treated by walking30 minutes daily divided into 5minutes every 2 hours to break sedentary position for 12 hours daily.
15778943|NCT04622358|Drug|AD-214-02|1 tablet administered before the breakfast during 7 days
15778944|NCT04622358|Drug|Rabeprazole|1 tablet administered before the breakfast during 7 days
15778945|NCT04622345|Drug|VSJ-110|ophthalmic solution
15778946|NCT04622345|Drug|Placebo|ophthalmic solution
15778947|NCT04622332|Drug|SIR1-365|Route of administration: oral
15778948|NCT04622332|Drug|Matching Placebo|Route of administration: oral
15778949|NCT04622319|Drug|DS-8201a|Administered initially as an intravenous (IV) infusion at a dose of 5.4 mg/kg on Day 1 of each 21-day cycle
15778950|NCT04622319|Drug|T-DM1|Administered initially as an intravenous (IV) infusion at a dose of 3.6 mg/kg on Day 1 of each 21-day cycle
15778951|NCT04622306|Device|Condom|Polyurethane Condom B
15778952|NCT04622293|Drug|Solriamfetol Oral Tablet [Sunosi]|Solriamfetol will be given to those participants placed in the experimental group, and given at three possible dosages ( 37.5 mg, 75 mg, and 150 mg). Solriamfetol is already FDA approved for treatment of excessive daytime sleepiness, and has been found safe to use. In this study, we are determining if solriamfetol can also be used to treat chronic fatigue syndrome.
15778953|NCT04622293|Drug|Placebo|A placebo encapsulated to look the same as the experimental drug will be given to the control group.
15778954|NCT04622267|Device|Barbed suture|to close a C-section incision
15778955|NCT04622267|Procedure|Standard antimicrobial suture|to close a C-section incision
15778958|NCT04622241|Other|Eave Tubes|The eave tubes are PVC tubes with a diameter of 15 cm installed in the outer wall of occupied rooms (e.g. bedrooms and living rooms but not storage rooms) at 1.5-2 m intervals, fitted with electrostatic mesh inserts coated with insecticides. No additional screening will be done. All households will be provided with piperonyl butoxide (PBO) long-lasting insecticidal nets (LLINs) - one for every two residents.
15778959|NCT04622241|Other|Eave Ribbons|"Eave ribbons are 15 cm-wide triple-layered hessian fabrics (burlap-line fabric woven from sisal fibres, procured locally), in lengths starting 1 m that can be attached to houses using nails, adhesives or Velcro, without completely closing eave-spaces. The eave ribbons will be treated by study staff with a commonly used spatial repellent, transfluthrin. Eave ribbons will be retreated by study staff after 6 months (only in Phase II, if selected for inclusion in the cluster-randomised trial).
~All households will be provided with piperonyl butoxide (PBO) long-lasting insecticidal nets (LLINs) - one for every two residents."
15778960|NCT04622241|Other|Full House Screening|"Full house screening includes screening eaves/ceilings, ventilation openings, and windows. Eaves/ceiling, air vents, and windows of eligible houses will be screened with wire mesh or other locally available screening materials. or ceilings, if eaves are closed and ventilation openings. We are also filling in any gaps in the walls. All households will be provided with piperonyl butoxide (PBO) long-lasting insecticidal nets (LLINs) - one for every two residents."
15778961|NCT04622241|Other|Partial House Screening|Partial screening will include either screening of the eaves or installing a screened ceiling, where no ceiling is present. In traditional houses, a netting (either insecticide-impregnated or untreated) may be either fixed in multiple places in the rafters or by hanging from a single central point and attached to the walls. No other screening or filling of the gaps will be done in partially screened houses.All households will be provided with piperonyl butoxide (PBO) long-lasting insecticidal nets (LLINs) - one for every two residents.
15778967|NCT04622215|Diagnostic Test|ICIQ questionnaire|questionnaire
15778968|NCT04622202|Drug|Pregabalin 150mg|oral capsule pregabalin 150 mg.
15778969|NCT04622202|Drug|multivitamin|oral placebo in the form of oral multivitamin capsule.
15778970|NCT04622189|Device|Action observation training|"Integration of four main tools:
~PATIENT INTERFACE, which has been implemented to present stimuli with a user friendly interface, with personalized menu and with the possibility to manage the training program; user personal page containing user information and history of activities with daily performance are stored too.
~MOCAP during action imitation will be recorded using MindMotion infrared camera to capture the trunk movement while an electromagnetic system (Trackstar from NDI) will be used to record fingers fine movements.
~EEG data will be collected during video observation using an Enobio wireless system integrated with the platform."
15778971|NCT04622176|Diagnostic Test|MMUS|MMUS will be used to perform diagnostics, we will compare with MRI and histology
15778972|NCT04622163|Other|Secondary Mentor|Subjects will be matched with a secondary mentor from the Department of Medicine for 6 months. Mentors and mentees are expected to hold one-on-one meetings monthly for the first 3 months followed by at least once every 3 months thereafter.
15778973|NCT04622163|Other|Career Development Resources|Subjects will receive career development resources.
15778974|NCT04622150|Behavioral|Customized Adherence Enhancement (CAE)|CAE is comprised of a series of up to four treatment modules whose inclusion is determined based upon an individuals reasons for nonadherence (adherence barriers).The standardized modules are Psychoeducation, Modified Motivational Interviewing, Communication with Providers, Medication Routines. CAE participants will have a core series of approximately four sessions spaced about one week apart over a period of 4-6 weeks, and one booster in-person session 4 weeks after the completion of the four core sessions (total of approximately 5 sessions). Sessions 2-4 will be delivered remotely by the study interventionist. All participants will have the first session in-person. The final booster session will be conducted at the sites and will review all previously introduced materials. There will be a follow-up phone call with the study interventionist that will occur in the four-week time period between completion of four CAE core sessions and prior to initiation of the booster CAE session.
15778975|NCT04622150|Behavioral|Enhanced Treatment as Usual (eTAU)|eTAU participants will receive monthly text messages (or phone calls for participants who prefer not to receive texts) to refill medications, fill eCAPs and brief general adherence promotion messages during the follow-up period.
15778976|NCT04622137|Procedure|Kinesiotaping therapy|The investigators used kinesiotaping strips in formations such as the Y, I, X, fan, web, and donut formations ove fractured clavicula.
15778977|NCT04622124|Drug|Placebo|
15778978|NCT04622124|Dietary Supplement|fasted vs. high-fat meal|
15778979|NCT04622124|Drug|Placebo|
15778980|NCT04622111|Drug|CPL207280|IMP is a tablet with CPL207280 as an Active Pharmaceutical Ingredient (API).
15778981|NCT04622111|Drug|Placebo|matching placebo tablet
15778982|NCT04622111|Drug|Metformin hydrochloride 750 mg|IMP is a tablet with Metformin hydrochloride as an Active Pharmaceutical Ingredient (API).
15778983|NCT04622098|Procedure|Endoscopic ultrasound|"this is an endoscopic procedure for the assessment of the lesions, the following will be recorded:
~the tumor location,
~layer of origin,
~maximal diameter,
~regularity of extraluminal border,
~echopattern,
~presence of cystic spaces or echogenic foci."
15778984|NCT04622085|Device|ANIMERS Chiara LA|20mg/SciVision Biotech Inc.
15778985|NCT04622085|Device|JUVÉDERM VOLUMA®|20mg/Allergan, Inc.
15778986|NCT04622072|Drug|XZP-5809-TT1 Tablet|Single tartrate of XZP-5809
15778987|NCT04622059|Behavioral|acoustic stimulation|"An auditive stimulus was produced by hitting a diapason on an acoustic surface, at a distance of 2-3 cm from the mother's skin (in order to avoid mechanical vibration to reach the fetus) in the area near the fetus' head.
~The same procedure was repeated three times, waiting 30 seconds between one stimulus and the following one. The total duration of stimulation was about 2 minutes."
15778988|NCT04622046|Drug|ALXN2060|ALXN2060 tablets will be administered twice daily at a dose of 800 milligrams.
15778989|NCT04622033|Biological|Brodalumab|brodalumab 210mg at week 0, 1, 2 and then every 2 weeks up to 24 weeks.
15778990|NCT04622020|Procedure|Cervical Plexus Block with Local Anaesthesia|Ultrasound guided intermediate cervical plexus block
15778991|NCT04622020|Procedure|Cervical Plexus Block with Depot Steroids|Ultrasound guided intermediate cervical plexus block
15778994|NCT04621994|Other|Dermabond|Dermabond will be applied after subcuticular skin closure in lieu of Steri Strips
15778995|NCT04621994|Other|Steri Strips|Steri Strips will be applied after subcuticular skin closure as routinely done at our institution
15778996|NCT04621981|Drug|Sodium Bicarbonate Ringer's Solution|This group was treated with Sodium Bicarbonate Ringer's Solution.
15778997|NCT04621981|Drug|Normal Saline|This group was treated with normal saline.
15778998|NCT04621942|Other|inertial rehabilitation|Inertial rehabilitation was performed twice a week (Monday and Thursday, between 5:00 and 8:00 PM) for 6 weeks using Cyklotren device (Inerion, Poland). Exercises were conducted by the same 2 researchers. Each training session included warm-up and 4 sets of shoulder ﬂexors, extensors, abductors, and adductors, with the right and left arms worked separately (16 sets for left and 16 sets for right arm). Each set lasted 15 seconds, a 2-minute break occurred between consecutive sets (without rest period between right and left arm). For all trained muscles 5 kg load was applied. During the training participants developed 70% of their maximal force achieved during the strength measurement. Participants observed developed during training force value displayed on-line on the screen. Cyklotren software allows to set the upper and lower limit of force; when developed strength was to low or to high a beep signal was emitted to correct participant force.
15778999|NCT04621942|Other|gymnastic rehabilitation|All women (from T and C group) participated in rehabilitation gymnastics twice a week during experiment (6 weeks). The gymnastics was conducted by a physiotherapist specializing in rehabilitation of women after mastectomy. The trehabilitation session lasted 45 minutes. During the sessions, the women mainly performed exercises involved shoulders, chest and the upper limbs muscles. Moreover, abdomen and back muscles were exercised.
15779000|NCT04621929|Drug|Phentermine / Topiramate Oral Product|All participants in the experimental group will receive oral generic tablet phentermine (18.75 or 37.5 mg dose) and topiramate (daily 100 mg or 150 mg dose)
15779083|NCT04621227|Drug|Rosuvastatin|10 mg single dose
15779001|NCT04621929|Combination Product|Citrate Salts, Allopurinol, Diet|Control participants will complete initial visit requirements and study enrollment and will be maintained on their current therapy.
15779002|NCT04621916|Drug|FVIII|This study will evaluate the inhibitor recurrence with or without ongoing FVIII exposure in patients with hemophilia A on emicizumab prophylaxis after a successful immune tolerance induction.
15779003|NCT04621916|Drug|Emicizumab|This study will evaluate the inhibitor recurrence with or without ongoing FVIII exposure in patients with hemophilia A on emicizumab prophylaxis after a successful immune tolerance induction.
15779004|NCT04621903|Other|Shanshamani Vati Plus|Shanshamani Vati Plus was given as combination of Guduchi (Tinospora Cordifolia; 300 mg) and Pipli (Piper Longum 75 mg) twice daily.
15779005|NCT04621890|Behavioral|LOAN2DOSE and COIN2DOSE|This is a behavioral economics intervention designed to help improve meal time bolusing behaviors in youth with type 1 diabetes.
15779006|NCT04621877|Behavioral|Volunteer-delivered Behavioral Activation|Behavioral Activation as delivered by trained volunteers
15779007|NCT04621877|Behavioral|Master's level clinician-delivered Behavioral Activation|Behavioral Activation as delivered by trained master's level clinicians
15779008|NCT04621838|Other|Assigned interventions.|"Subjects will undergo treatment of their chronic and acute wounds as indicated in instructions for use, with Silicone Foam Dressing and Silicone Foam Lite Dressing.
~The patients will be evaluated at each dressing change over a six-week period (per Product) or until the wound is healed to extent that the use of the Silicone Foam and Silicone Foam Lite dressing is no longer indicated from the time that the patient has been recruited."
15779009|NCT04621825|Device|ActivHeal Silicone PHMB Foam Adhesive and Non Adhesive dressing.|"Assigned interventions Subjects will undergo treatment of their chronic and acute wounds as indicated in instructions for use with ActivHeal Silicone PHMB Foam adhesive and Non Adhesive Foam dressings.
~Subjects will be evaluated as follows:
~Full Patient and wound assessment, Informed consent. Wound Assessment, application of dressings, (At each scheduled dressing change.) Wound Assessment, removal of dressings, (At each scheduled dressing change.) The patients will be evaluated at each dressing change over a four - six-week period (per AMS Product) or until the wound is healed to extent that the use of the ActivHeal Silicone PHMB Foam adhesive and Non Adhesive Foam dressings. is no longer indicated from the time that the patient has been recruited.
~The assessment of the presence and reduction of the signs and symptoms of Infection."
15779010|NCT04621799|Drug|Fibrin sealant|The intra-annular delivery of non-autologous fibrin into the annulus
15779011|NCT04621786|Device|Mecta Spectrum 5000Q paired with Soterix Medical 4X1 HD - ECT Multi-Channel Stimulation Interface|The Mecta Spectrum 5000Q paired with Soterix Medical 4X1 HD-ECT Multi-Channel Stimulation Interface will reduce ECT current amplitude for amplitude-seizure titration.
15779012|NCT04621773|Procedure|Preimplantation Genetic Screening(exposure)|Preimplantation genetic screening (PGS) was developed in the late 1980s as an alternative to prenatal diagnosis for couples at risk of transmitting a genetic or chromosomal abnormality to their children. In embryos created through in vitro fertilisation (IVF), cells are biopsied and analysed using genetic tests such as polymerase chain reaction and fluorescent in situ hybridisation (FISH).
15779013|NCT04621760|Behavioral|HIV Prevention Decision Support Tool (DST)|The tool is founded on principles of decision-science and developed in a systematic manner including pilot testing. The tool will present HIV prevention information through a tablet in the clinical setting. The decision support tool will address barriers to PrEP delivery, including 1) limited client knowledge about PrEP, 2) limited time to educate patients in busy clinics, 3) women's lack of knowledge of their own HIV vulnerability, and 4) hesitancy of women to initiate discussions about PrEP with providers due to judgmental attitudes and stigma. Also, the tool emphasizes the highly variable and individual nature of baseline risk.
15779014|NCT04621760|Behavioral|Standard Counseling|Participants in this arm will receive usual care.
15779015|NCT04621747|Other|Battery of neurophysiological explorations|"Visit 1: Biometry collection: gender, age, weight, height, eye colour.
~Questionnaires : the State and Trait Anxiety Inventory and the Pain Sensitivity
~Threshold of unpleasant light brightness, mechanical sensitivity threshold (von Frey hair).
~Training to estimate unpleasantness Under nociceptive and tickling stimuli, to use the handgrip.
~Mechanical pain threshold (electronic von Frey), heat pain threshold (Medoc Pathway).
~48 stimulations applied to the back skin, following a predetermined plan with 12 different pathways, imbricated with 4 different speeds of movement.
~Visit 2 (1 to 8 days later) :
~42 stimulations applied to the back skin, to test the effect of stimulation intensity, the side of application, continuity break of the contact, and distraction by other cutaneous stimuli. The stimuli will follow the best paradigm as identified at the previous visit.
~12 stimulations applied to forearm, cheeks, lower limbs, also testing the effect of hairiness."
15779016|NCT04621734|Device|AMT BridlePro Device|A device used as an alternative securement method using the structure of the nasal cavity to secure the nasoenteric tube.
15779017|NCT04621734|Device|Adhesive Tape|Adhesive tape used to secure nasoenteric tube
15779018|NCT04621721|Behavioral|Gait/balance & resistive exercise|Walking forward and back, walking with head motion, static standing, Standing Partial Tandem, Tandem Standing heel to toe, Standing with head turns Single leg stance and March in place. Resistance exercises include: calf raises, lunges, supine leg curls and extensions.
15779019|NCT04621708|Device|Repetitive transcranial magnetic stimulation|Left DLPFC iTBS rTMS
15779020|NCT04621695|Procedure|RBL|Both arms are standard care procedures in the Netherlands
15779021|NCT04621695|Procedure|Hemorrhoidectomy|Both arms are standard care procedures in the Netherlands
15779022|NCT04621682|Other|Non technical skills and checklist training in simulation|using structured debrifing, in three random medical simulation crises, training in non-technical skills will be carried out
15779023|NCT04621682|Other|Checklist training simulation|using structured debrifing, in three random medical simulation crises, training in checklist will be carried out
15779024|NCT04621669|Drug|SHR3680|240 mg
15779025|NCT04621669|Drug|digoxin|0.25 mg
15779026|NCT04621669|Drug|Rosuvastatin calcium|10 mg
15779027|NCT04621669|Drug|metformin hydrochloride|500 mg
15779084|NCT04621227|Drug|Midazolam|2mg single dose
15779089|NCT04621175|Dietary Supplement|EAA+W & EAA|Essential amino acid plus whey beverage with added essential amino acid
15779275|NCT04619849|Diagnostic Test|EMG|Electromyography (EMG) is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles.
15779028|NCT04621656|Combination Product|January Mobile Application (Sugar AI)|Sugar AI is a mobile health and fitness app the allows participants to log and record health-related data through Continuous Glucose Monitors, Heart Rate Monitors, and manual food, water, and activity logging. Using machine learning data science techniques, the Sugar AI App integrates the data collected to personalize lifestyle recommendations and help individuals optimize their health and wellness.
15779029|NCT04621643|Behavioral|digital cognitive behavioral therapy (dCBT-I)|dCBT-I during 9 weeks. Multicomponent intervention that includes the following: psychoeducation about sleep, sleep hygiene, sleep restriction therapy, stimulus control and challenging beliefs and perception about sleep. The digital CBT-I that will be utilized in this study is named Sleep Healthy Using The internet (SHUTi). The intervention is fully automated with no contact with health care personnel, it is interactive and adapts to input from the users. It comprises of the same elements included in face-to-face CBT-I, but the user gains access to a new educational, behavioral or cognitive module each week only after completion of digital sleep diaries. dCBT-I can be accessed on computers or hand-held devices
15779030|NCT04621643|Behavioral|Digital patient education about insomnia (PE)|Control condition PE during 9 weeks. A digital patient education program that can be accessed on computers or hand-held devices. The information overlaps with that included in the dCBT-I intervention but it does not include any of the interactive features of the dCBT-I intervention and all the information is available from the moment the PE site is opened.
15779031|NCT04621630|Drug|PN-235|Active Drug
15779032|NCT04621630|Drug|Placebo|Matching Placebo
15779033|NCT04621617|Drug|Albumin|Human albumin will be administered by intravenous infusion at a dose of 1.5 gm/kg/week for 2 weeks followed by HA 40 grams every 7days
15779034|NCT04621617|Drug|Midodrine|Oral Midodrine will be given at a dose of 7.5 mg three times in a day
15779035|NCT04621617|Drug|Standard medical therapy (SMT)|SMT will include nutritional support, rifaximin, lactulose or lactitol, diuretics, SBP prophylaxis with norfloxacin, restriction of sodium, multivitamins, and other supportive measures as deemed necessary. LVP will be done as needed. Patients on non-selective beta blockers will continue to do so with dose modifications/withdrawal as per Baveno VI guidelines.
15779036|NCT04621604|Other|blood samples|Extra blood samples will be collected during chemotherapy administration to analyze pharmacokinetics of the iPD1
15779037|NCT04621591|Device|Saneso 360° gastroscope|Subjects will have a clinically indicated per standard of care routine EGD procedure performed with the Saneso 360° gastroscope.
15779038|NCT04621578|Device|HANS 100B stimulator (4 conductors, 8 electrodes; Jisheng Co., Nanjing, China)|"Stimulation sites: Mastoid area on the contralateral side of the operation, Fengchi acupoint on the contralateral side of the operation, and Neiguan acupoints on both sides.
~Timing of stimulation: In postanesthesia care unit (PACU) after extubation, 6 hours, 24 hours, 48 hours, and 72 hours after returning to the ward. 30-minutes treatment for each time-point."
15779039|NCT04621565|Drug|Normal saline|No hydrocortisone or other steroids are given before, during, and after the surgery, except that patients develop postoperative adrenal insufficiency. If a patient develops postoperative adrenal insufficiency, he/she needs to receive hydrocortisone treatment (20mg at 0800 and 20mg at 1600) for one month and then check the level of morning serum cortisol to decide if it is time to start the hydrocortisone taper program.
15779040|NCT04621565|Drug|Hydrocortisone|"Hydrocortisone sodium succinate is given on the operation day (100mg at 0800 & 100mg at 2000), the postoperative day 1 (100mg at 0800 & 50mg at 2000), and the postoperative day 2 (25mg at 0800). Hydrocortisone (po.) is then given starting from the afternoon of postoperative day 2 (20mg at 1600 and 0800) to the end of the first postoperative week, and 20mg at 0800 during the second postoperative week. This is called the hydrocortisone taper program. If a patient develops postoperative adrenal insufficiency, he/she needs to receive hydrocortisone treatment (20mg at 0800 and 20mg at 1600) for one month and then check the level of morning serum cortisol to decide if it is time to start the hydrocortisone taper program."
15779041|NCT04621552|Device|WEB embolization|Treatment of intracranial aneurysms with WEB with the use of the virtual simulation before implantation of the device
15779042|NCT04621526|Drug|dexmedetomidine- ketamine|patients will receive combination of ketamine 1.5mg/kg and dexmedetomidine 0.5ug/kg diluted in 10 ml 0.9% saline infused over 10 min together as an intravenous bolus dose then a maintenance of 0.5ug/kg/h dexmedetomidine and ketamine 0.5 mg/kg/h continuous infusion in two separate syringes pump to achieve modified Observer's Assessment of Alertness and sedation score (OAA/S) 3 and the infusion will stopped by finishing the skin suture.
15779043|NCT04621526|Drug|dexmedetomidine- propofol|patients will receive combination from 1 mg/kg propofol and dexmedetomidine 0.5ug/kg diluted in 10 ml 0.9% saline infused over 10 min together as an intravenous bolus dose then a maintenance of 0.5ug/kg/h dexmedetomidine and propofol 1 mg/kg/h continuous infusion in two separate syringes pump to achieve modified Observer's Assessment of Alertness and sedation score (OAA/S) 3 and the infusion will stopped by finishing the skin suture.
15779044|NCT04621513|Device|laser acupuncture (RJ laser S/N 1813458)|use a low-level-laser acupuncture on acupoint
15779045|NCT04621513|Drug|western medicine|Montelukast 4mg 1 tablet HS AVAMYS nasal spray 27.5μg QD
15779046|NCT04621500|Drug|cholecalciferol|Enrolled subjects will supplement with vitamin D3 at 4,000 IU daily for one year
15779047|NCT04621487|Drug|Amoxicillin|14 days 1 gr bid
15779048|NCT04621487|Drug|Metronidazole|14 days 500 mg bid
15779049|NCT04621487|Drug|Clarithromycin|14 days 500 mg bid
15779050|NCT04621487|Drug|Pantoprazole 40mg|40 mg bid 14 days
15779051|NCT04621487|Drug|according to antibiogram|according to antibiogram
15779052|NCT04621474|Diagnostic Test|Narrow band imaging (NBI)|Narrow-band imaging uses specific light wavelengths of 415 nm (blue) and 540 nm (green) due to a special filter which is electronically activated by a switch in the endoscope.
15779053|NCT04621461|Dietary Supplement|Zinc Sulfate 220 MG|220mg once daily for 5 days
15779054|NCT04621461|Drug|Placebo|Once daily for 5 days
15779085|NCT04621214|Device|Audio-Visual Triage System (AVT)|Audio System was added to visual triage that resulted in an AVT. Protocols of AVT included, a medical personal sits on TRIAGE DESK (with glass barrier sheet on it) wearing personal protective equipment (PPE) at a distance of more than 6 feet from the PATIENT DESK. Both desks are connected with Non-touchable MIC SYSTEM for communication
15779086|NCT04621201|Other|observation and biopsy|biopsy
15779087|NCT04621188|Drug|Lorlatinib|100 mg once daily
15779055|NCT04621448|Behavioral|Moving Together|"Two-way livestreaming virtual group classes will be offered for 1 hour, 2 days/week for 12 weeks to all participants. Classes will be led by a trained instructor who will demonstrate all movements and will provide brief explanations for the goals of movements. Consistent with the in-person program, classes will focus on the 7 guiding principles of Moving Together:
~repetition with variation (to promote procedural learning);
~progressive, functional movements (to improve daily function);
~slow pace and step-by-step instruction (to minimize cognitive demands);
~participant-centered goal orientation (to enhance personal meaningfulness of movements);
~body awareness, mindfulness and breathing (to encourage present-centeredness);
~social interaction (to promote meaningful connection); and
~positive emotions (to promote feelings of well-being."
15779056|NCT04621435|Drug|Gallium-68 labelled (68Ga-) FAP-2286|The dose will be 3 to 8 millicurie (mCi) +/- 10% given intravenously at a single time prior to imaging
15779057|NCT04621435|Procedure|Positron Emission Tomography (PET) imaging|Participants will be scanned for approximately 30 to 45 minutes
15779058|NCT04621422|Biological|Subject carrying an amplification of nucleotide repeats in one of the following 9 genes FMR1, DMPK, ZNF9, SCA2, JPH3, HD, FXN, C9ORF72, RFC1|Biological/Vaccine: DNA Samples collection as part of usual care
15779059|NCT04621409|Biological|Liver-enriched antimicrobial peptide 2|IV infusion of LEAP2, approximately 5 hours
15779060|NCT04621409|Biological|Placebo|IV infusion of saline, approximately 5 hours
15779061|NCT04621396|Other|Observational screening study|
15779062|NCT04621383|Dietary Supplement|Whey protein plus collagen|This two-arm randomized, double-blind, placebo-controlled design was carried out over a period of 17 weeks. At the beginning of the experiment, two weeks and at the end three weeks were allocated for evaluations consisting of anthropometric (weeks 2 and 16), body composition (weeks 2 and 16), one repetition maximum tests (weeks 1 and 15), functional capacity tests (weeks 1 and 15), blood samples (weeks 2 and 16), magnetic ressonance imaging (weeks 2 and 17) and dietary intake measurements (weeks 1 and 15). The anthropometric, body composition, blood samples and dietary intake measurements were carried out in a temperature-controlled room (22-24 °C), and the RT sessions were conducted at the university training facility.
15779063|NCT04621383|Dietary Supplement|Whey protein plus maltodextrin|This two-arm randomized, double-blind, placebo-controlled design was carried out over a period of 17 weeks. At the beginning of the experiment, two weeks and at the end three weeks were allocated for evaluations consisting of anthropometric (weeks 2 and 16), body composition (weeks 2 and 16), one repetition maximum tests (weeks 1 and 15), functional capacity tests (weeks 1 and 15), blood samples (weeks 2 and 16), magnetic ressonance imaging (weeks 2 and 17) and dietary intake measurements (weeks 1 and 15). The anthropometric, body composition, blood samples and dietary intake measurements were carried out in a temperature-controlled room (22-24 °C), and the RT sessions were conducted at the university training facility.
15779064|NCT04621370|Drug|Durvalumab|Flat dose of 1500mg delivered intravenously over 30 minutes every 4 weeks.
15779065|NCT04621370|Drug|FOLFOX|"Oxaliplatin 85mg/m2 delivered intravenously as per institutional standard on Day 1 of mFOLFOX6 treatment every 2 weeks.
~5-fluorouracil bolus 400mg/m2 delivered intravenously as per institutional standard on D1 of mFOLFOX6 treatment every 2 weeks.
~5-fluorouracil infusion 2400mg/m2 delivered intravenously over 46 hours continuously as per institutional standard following bolus 5-fluorouracil."
15779066|NCT04621370|Radiation|Short Course Radiotherapy (Arm A)|25 Gray of photon radiation treatment delivered over 5 fractions.
15779067|NCT04621370|Radiation|Long course chemoradiation (Arm B)|50 Gray of photon radiation treatment delivered over 25 fractions.
15779068|NCT04621370|Drug|Capecitabine|Capecitabine is a non-cytotoxic pre-cursor of cytotoxic 5-fluorouracil and delivered in oral form. It is given concomitantly with long course radiation treatment on days of radiotherapy only. The dose is 825mg/m2 and this is delivered twice daily.
15779069|NCT04621357|Radiation|Brain MRI|Brain MRI will include differents sequences.
15779070|NCT04621357|Biological|Biological biomarkers|Biological biomarkers will include a set of systemic inflammatory markers
15779071|NCT04621344|Diagnostic Test|Guided bronchoscopy and/or endosonography|Endoscopic procedures aimed at sampling of intrathoracic lymph nodes or pulmonary lesions
15779072|NCT04621331|Drug|Roxadustat|HIF-PH inhibitor for treatment of anemia in CKD
15779073|NCT04621318|Drug|Denosumab|60 mg, single-dose
15779074|NCT04621305|Other|normal saline|Anesthesia is maintained by sevoflurane and continuous infusion of normal saline(1ml/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2ml/kg normal saline is administered
15779075|NCT04621305|Drug|Bolus Remimazolam|Anesthesia is maintained by sevoflurane and continuous infusion of normal saline(1ml/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2mg/kg remimazolam is administered.
15779076|NCT04621305|Drug|Continuous Infusion Remimazolam|Anesthesia is maintained by sevoflurane and continuous infusion of remimazolam(1mg/kg/h) is administered until about 5min before the end of the surgery. Then intravenous bolus of 0.2ml/kg normal saline is administered.
15779077|NCT04621279|Procedure|Normothermia|Usual care for first 72 hours for neonates with mild encephaolpathy maintaining core temperature 36.0 - 37.0.
15779078|NCT04621279|Procedure|Whole body therapeutic hypothermia|Whole body therapeutic hypothermia (33.5°C + 0.5°C) for 72 hours begun by 6 hours of age, followed by rewarming at 0.5°C/hour for neonates with mild encephaolpathy per site standard of care practice.
15779079|NCT04621266|Behavioral|Home-based peer support|Home-based peer support will be provided to support participants' breastfeeding. There will be a minimum of 2 and maximum of 3 home visits between trained peer counsellors and participants. Each session will last approximately 30 minutes.
15779080|NCT04621253|Drug|Novalgin|Single dose of 1000 mg metamizole, 1h after the last inhibitor or placebo intake
15779081|NCT04621240|Behavioral|Online SMART & Stress Solutions|1. On-line SMART - (Strategic Memory Advanced Reasoning Training) is a curriculum that teaches strategies of how to use the brain better, in such a way that may improve brain health and performance. SMART strives to achieve optimal cognitive function realized by the brain's ability to efficiently manage complex information by abstracting its essential meaning rather than attempting to memorize details, and to prioritize the information in order to attend to the most relevant parts. 2. Stress Solutions - provides individuals with practical tools to enhance performance, reduce stress, build resilience and improve quality of life.
15779082|NCT04621227|Drug|PF-06882961|120 mg and 200 mg BID
15779090|NCT04621162|Behavioral|Positive Expectations (initial)|"A positive expectation of the effect of motor imagery will be given before beginning the mental practice of imagination. This task will generate hypoalgesia"
15779091|NCT04621162|Behavioral|Negative Expectations (initial)|"A negative expectation of the effect of motor imagery will be given before beginning the mental practice of imagination. This task will not generate hypoalgesia"
15779092|NCT04621162|Behavioral|Neutral Expectations (initial)|This group will act as a control. No expectations will be given that will influence the participant.
15779093|NCT04621162|Behavioral|Positive Expectations (during intervention)|"A positive expectation will be given during the performance of the mental practice. This is working very well"
15779094|NCT04621162|Behavioral|Experimental: Negative Expectations (during intervention)|"A negative expectation will be given during the performance of the mental practice. This is working very bad"
15779095|NCT04621162|Behavioral|Neutral Expectations (during intervention)|This group will act as a control. No expectations will be given that will influence the participant.
15779096|NCT04621149|Other|chlorine dioxide|chlorine dioxide is an antimicrobial agent used for a variety of purposes including as a water purification product, a disinfectant on food, etc.
15779097|NCT04621149|Dietary Supplement|zinc acetate|zinc acetate lozenges have been suggested to have antiviral properties
15779098|NCT04621149|Drug|Famotidine|famoitidine is a histamine-2 blocker sold over the counter to reduce stomach acid
15779099|NCT04621149|Other|placebo|filtered water
15779100|NCT04621149|Dietary Supplement|lactoferrin, green tea extract|lactoferrin and green tea extract are dietary supplements
15779101|NCT04621136|Drug|Ripasudil ophthalmic solution 0.4%|"Phase1 A total of three infants will receive ripasudil eye drops(0.4%) once daily for one week, followed by twice-daily drug administration for two weeks. The three infants who participate in Phase1 can continue to receive the eye drop treatment for additional 9 weeks(12 weeks in total)if the investigators determine that there are no safety issues with ripasudil. In addition, a data and safety monitoring board(DSMB)will be held two times to decide whether the new patients can be enrolled into phase1, and also if phase2 can begin.
~Phase2:A total of 21 patients will receive ripasudil eye drops(0.4%)twice daily for 12 weeks."
15779102|NCT04621123|Biological|Convalescent anti-SARS-CoV-2 MBT plasma|Subjects randomized to combination convalescent anti-SARS-CoV-2 MBT plasma plus SMT will undergo an ABO compatibility test and will receive a single infusion of 200 to 300 ml of ABO-compatible convalescent plasma
15779103|NCT04621123|Other|Control Group|Subjects randomized to placebo plus SMT will receive one infusion of 200 to 300ml of sterile saline solution 0.9%.
15779104|NCT04621110|Drug|intranasal dexmedetomidine|Dexmedetomidine (precedex®) will be administered by intranasal route in 1ug/kg each dose, repeating at most 3 times to see if it can give enough sedation to painful procedure. To assess the level of sedation the study will use Ramsay sedation scale.
15779105|NCT04621110|Drug|intranasal fentanyl|Fentanyl will be administered by intranasal route in 1,5ug/kg each dose, repeating at most 3 times to see if it can give enough pain relief for painful procedure. To assess pain control the study will use Face, Legs, Activity, Cry, Consolability scale ( FLACC)
15779106|NCT04621110|Drug|intravenous ketamine (ketalar®)|Ketamine (ketalar®) will be administrated by intravenous route in 1mg/kg dose and the study will use this drug to compare the efficiency of intranasal drugs.
15779107|NCT04621110|Drug|intravenous midazolam|Midazolam will be administrated by intravenous route in 0,1mg/kg dose and the study will use this drug to compare the efficiency of intranasal drugs.
15779108|NCT04621097|Device|pulsed electromagnetic field|it is a device for magnetotherapy and it is one of the most recent noninvasive physical therapy modality which is used in multiple physical therapy fields . it consist of an appliance, motorized bed and solenoid . the appliance must be connected to electrical supplying 230 =10% at a frequency of 50 or 60 HZ with earth connection . the intensity and spatial lay out of the generated magnetic field depend on the type of solenoid used
15779109|NCT04621097|Other|treadmill training|supervised treadmill walking exercise. The exercise program consists of intermittent walking bouts to moderate claudication pain alternating with periods of rest in between for a total of 40-50 minutes .
15779110|NCT04621097|Drug|Medication|regular medications
15779111|NCT04621084|Behavioral|Eating habits|Questionnary online
15779114|NCT04621058|Drug|Vitamin D|In case of Vitamin D levels <30 or 40ng/ml patients will take vitamin D supplements.
15779115|NCT04621058|Drug|PLACEBO|Placebo capsules exactly the same as the above, but without the active component.
15779116|NCT04621045|Behavioral|The Physical Activity for The Heart (PATH) intervention|The web-based Physical Activity for The Heart (PATH) intervention leverages openly accessible platforms, such as YouTube, to proffer workout videos that match the participants preferences. Currently, PATH includes over 90 workout videos vetted by a team of experts and curated on the PATH website in 3 controlled levels of intensity (beginner, intermediate, proficient) to foster gradual progression from low to high intensity PA in accordance with the FITT-VP (frequency, intensity, time, type, volume, progression) principle.
15779117|NCT04621045|Behavioral|Be Active Your Way Booklet|Be Active Your Way booklet was developed by the Centers for Disease Control (CDC) to help individuals integrate PA in their daily lives. It simply encourages individuals to increase their PA gradually and gives them examples of things that they can do.
15779118|NCT04621032|Diagnostic Test|Polygraphy monitoring|All patients with visceral obesity have been tested for Obstructive Sleep Apnea and heart rhythm disorders by usage of polygraphy and Holter-ECG monitoring.
15779119|NCT04621032|Diagnostic Test|laboratory tests|Blood samples for sodium, potassium, calcium, magnesium concentration and fasting glyceamia assessment hae been taken from all patients with visceral obesity.
15779120|NCT04621019|Device|BTL-785F|Treatment with study device.
15779121|NCT04621006|Diagnostic Test|Consecutively assessment of the disease activity|Analyzes listed in the detailed study description is measured consecutively. SIBDQ and lower endoscopy are performed at only 3 visits. The remaining analyzes are performed at each visit.
15779236|NCT04620148|Drug|Placebo|Matching placebo concentrate solution
15779237|NCT04620135|Drug|Netarsudil ophthalmic solution 0.02%|Topical sterile ophthalmic solution Other Name: Rhopressa®
15779122|NCT04620993|Other|Evaluation of biomechanics and viscoelastic properties of plantar fascia|"The biomechanical and viscoelastic properties of the plantar fascia will be measured in the side lying position.
~Measurements will be made with the ankle in neutral position and maximum dorsi flexion position."
15779123|NCT04620993|Other|Evaluation of navıcular drop|The amount of navicular drop of both feet will be measured
15779124|NCT04620993|Other|Evaluation of plantar pressure distrubution|The distribution of foot plantar pressure and the amount of change in the center of gravity will be measured in the free standing position.
15779125|NCT04620980|Diagnostic Test|targeted resequencing|The investigators will use a disease-specific gene panel including about 100 genes related to Parkinson's Disease, autophagy and levodopa induced Dyskinesia (LID).
15779126|NCT04620967|Drug|Insulin aspart|Insulin aspart (Iasp) in insulin pump
15779127|NCT04620967|Drug|Fast-acting insulin aspart|Fast-acting insulin aspart (Fiasp) in insulin pump
15779128|NCT04620954|Drug|Oregovomab|2mg of Oregovomab is administered through IV on Weeks 1, 5, 9, 17.
15779129|NCT04620954|Drug|Nivolumab|480mg of Nivolumab is administered through IV every 4 weeks (Weeks 9, 13, 17, 21).
15779130|NCT04620954|Drug|Chemotherapy|Pegylated liposomal doxorubicin (PLD) and carboplatin are administered every 4 weeks through IV. The starting dose of PLD and carboplatin are 30mg/m^2 and 5 AUC (Area Under the Curve) respectively.
15779131|NCT04620928|Behavioral|Concepts|Images and sounds that are characteristic of various common objects.
15779132|NCT04620915|Behavioral|High-level construal|"In the high-level construal condition, participants will be sent messages asking them to consider why they are quitting (What are your main reasons for quitting?) and to imagine what their lives will look like in the future if they succeed (What would quitting mean to you and your family's future?; Yeager et al., 2014). The corpus for this condition is 100 messages composed by a large independent sample of mTurk workers who are smokers and validated by a team of RAs trained to 0.8 reliability on ratings of high-level construal. To meet criteria for inclusion, a message must be rated as significantly closer to high-level (vs. low-level) on a rating scale of construal level.
~In addition to the texting, participants will complete biweekly online booster sessions using Qualtrics with a custom, personalized link sent to the participant via email and text."
15779133|NCT04620915|Behavioral|Down-regulation of craving for cigarettes|"In the down-regulation of craving condition, participants will be sent messages that encourage inhibitory control of cravings for cigarettes (e.g., using cognitive reappraisal or attentional control) and that provide strategies to do so (e.g., When you feel an urge to smoke, think about the health consequences). The corpus for this condition is 100 messages composed by a large, independent sample of mTurk smokers and validated by a team of RAs trained to 0.8 reliability on ratings of plausibility AND effortful cognitive inhibition or control.
~In addition to the texting, participants will complete biweekly online booster sessions using Qualtrics with a custom, personalized link sent to the participant via email and text."
15779134|NCT04620915|Behavioral|Up-regulation of goal energization|"In the up-regulation of goal energization condition, participants will be sent messages that encourage them to consider the core values that drive their desire to quit smoking. These messages will name a specific core value that the participant rated in the top three (of 19) during the baseline session, and will draw a connection between quitting and the core value. For example, a message for a person who nominated family as one of her top three core values might read, Quitting will help you model a healthy lifestyle for your family. This intervention is grounded in robust theory and evidence supporting Self-Affirmation Theory. The corpus for this condition is 100 messages composed by a large, independent sample of mTurk smokers and validated by a team of RAs trained to 0.8 reliability in correctly identifying to which core value the message is tied.
~In addition to the texting, participants will complete biweekly online booster sessions using Qualtrics."
15779135|NCT04620915|Behavioral|Treatment-as-usual control|"In the treatment-as-usual (TAU) control condition, participants will be sent generic messages through NCI's text messaging cessation program, SmokefreeTXT (National Cancer Institute, 2013). An example message is, SmokefreeTXT: Cravings are tough, but you can do this. Avoid big triggers for now & focus on beating smaller ones. Practice makes perfect. The control messages provide affect regulation strategies and information, and do not overlap with the messages from the other three arms of the study.
~In addition to the text messaging, participants in the TAU condition will be invited to visit a website with information about the dangers of smoking and benefits of quitting. Twice per week, they will be sent a custom, personalized, and trackable link to the website via email and text messaging."
15779136|NCT04620902|Other|Tear sampling|Tear sampling using Schirmer's strips
15779137|NCT04620889|Device|AV Access|Arteriovenous shunting for blood access.
15779138|NCT04620889|Device|PVP|Bypass or reconstruction of diseased or occluded blood vessels
15779139|NCT04620876|Other|Bimodal high resolution imaging of the retina|The protocol consists of performing an Optical coherence tomography and Scanning laser ophthalmoscope system using adaptive optics (AO-SLO-OCT).The participant is asked to put his forehead against the temple supports and his chin on a chin rest. The subject will be asked to fix a test pattern in the form of a cross. The pattern is positioned according to the desired eccentricity with respect to the fovea. The actual acquisition lasts a few seconds, possibly repeated to cover the field of the desired eye. The acquisition protocol depends on the subjects, their pathology and the system used; the area examined will be modified on a case by case basis. The total duration of each exam can be estimated at less than half an hour, with frequent breaks.
15779140|NCT04620863|Other|t-DCS group|All the participants received daily stimulation sessions for 5 consecutive days, starting from the first Monday after hospital admission (Monday to Friday). The primary motor cortex (M1) was identified using the International 10-20 system for C3 (left M1) or C4 (right M1). For the stimulation, the anode was placed over the primary motor cortex (M1) ipsilateral to the side of trunk deviation, and the cathode was placed over the primary motor cortex (M1) contralateral to the side of trunk deviation (bi-hemispheric stimulation).
15779141|NCT04620863|Other|Sham group|The stimulation setting was exactly the same but the stimulation intensity was set according to a ramping up/ramping down method and delivered only in the first and last 30 seconds of each session. This stimulation paradigm is insufficient to produce a meaningful therapeutic effect, but it is necessary to guarantee the blind condition as it mimics the possible initial tingling sensation associated with active stimulation.
15779142|NCT04620850|Device|Acupressure|Acupressure after cesarean section 3 hr and then next 3 hr (duration 10 min per time)
15779143|NCT04620837|Drug|Tislelizumab|Tislelizumab：200mg Q3W IV. There will be no dose reduction for Tislelizumab ， if there is no disease progression or serious Treatment Related adverse events(TRAE) , patients will receive Tislelizumab (200mg,Q3W) until progression or death
15779144|NCT04620837|Drug|Anlotinib hydrochloride|Anlotinib hydrochloride capsules: Capsule; specifications 12mg; oral, once a day, every 12mg, continuous medication two weeks after 1 week deactivated. Depending tolerated dose reduction. Medication process: disease control and patients can tolerate the side effects, continued drug use; researchers believe the patient is not fit to continue medication or efficacy evaluation at the end of the clinical progression of medication.
15779145|NCT04620811|Drug|lirentelimab|Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8
15779146|NCT04620798|Behavioral|Immediate vs. delayed provision of antibody test results|The primary experiment will be assessing whether provision of the antibody test results leads to behavior change with respect to personal protective behaviors. To that end, we will randomize all participants to a trial arm that immediately receive results (within 24 hours) or a trial arm with a delayed provision of results (after 4 weeks).
15779147|NCT04620785|Other|methylene blue / IPL|therapeutic
15779148|NCT04620785|Other|IPL|therapeutic
15779149|NCT04620785|Other|saline|placebo
15779150|NCT04620772|Drug|Cyclophosphamide injection|Cyclophosphamide vs placebo
15779151|NCT04620759|Drug|Psilocybin|The psilocybin used in this study is synthetically manufactured and formulated under current good manufacturing practices (cGMP). The active drug is encapsulated using a size 0 blue gelatin capsule and contains 25 mg of psilocybin.
15779152|NCT04620759|Drug|Placebo|The placebo used in this study is microcrystalline cellulose, an inert substance, encapsulated using a size 0 blue gelatin capsule.
15779153|NCT04620746|Drug|Penicillin Major Determinant (PrePen) Skin Testing|Skin testing followed by oral challenge with amoxicillin 250 mg single dose
15779154|NCT04620746|Drug|Direct Oral challenge|Direct oral challenge with test dose of amoxicillin 25mg followed by amoxicillin 250mg single dose
15779158|NCT04620720|Drug|capule gabapentin|neuropathic analgesic
15779159|NCT04620707|Device|RGS based training and monitoring|The RGS treatment will consist in a variable number of sessions per week of RGS-based training. Each session consists of cognitive and motor training involving reaching, grasping, placing virtual objects. The duration of the training period will be variable. Patients will use the RGS@Clinic from admission to discharge, and will have the RGS@Home during the first 3 months of the outpatient stage after recruitment. After this period of time, the patient will be evaluated by clinicians and the RGS@Home system will be collected. The RGS-Wear will be kept by the patient also during the follow-up period, up to 1 year post-recruitment.
15779160|NCT04620707|Behavioral|Therapy as usual|The patients will follow treatment as usual, including conventional rehabilitation and physical therapy when corresponding. The exact treatment that the patients will receive will depend on the local medical guidelines.
15779161|NCT04620694|Device|Choice of arterial cannulation site at the beginning of the surgery|Choice of arterial cannulation site at the beginning of the surgery is at the discretion of the anesthesia physician.
15779162|NCT04620681|Biological|CD8 Depleted, Non-engrafting,HLA mismatched unrelated donor lymphocytes|Infusion of mononuclear cells, apheresis products depleted of CD8+ T cells using the CliniMACS® system with CliniMACS® CD8 reagent
15779163|NCT04620681|Drug|Standard of Care Chemotherapy|Standard of care cytarabine-based chemotherapy
15779164|NCT04620668|Device|Wysa|Wysa is an AI-based mental health chatbot. It uses evidence-based techniques to help users build mental resilience skills and improve their mental health.
15779165|NCT04620655|Drug|RD13-01 cell infusion|Universal CAR-T cells targeting CD7
15779166|NCT04620642|Biological|Registry|No specific intervention. Data of the usual care will be collected as the medical history, the demographic data, the biological analyses, imaging report, etc.
15779167|NCT04620616|Other|RELX ENDS Tobacco Flavor|Ad libitum use of the RELX ENDS tobacco flavor product during 8-hour and 5-minute use sessions
15779168|NCT04620616|Other|RELX ENDS Menthol Flavor|Ad libitum use of the RELX ENDS tobacco flavor product during 8-hour and 5-minute use sessions
15779169|NCT04620616|Other|Subject Usual Brand ENDS|Ad libitum use of the usual brand product during 8-hour and 5-minute use sessions
15779170|NCT04620603|Radiation|Low Dose Rate Brachytherapy (LDR)|LDR on treatment day 1
15779171|NCT04620603|Drug|Nivolumab|IV infusion 480mg every 28 days, 12 cycles total
15779172|NCT04620590|Drug|Dapagliflozin 10 MG [Farxiga]|Dapagliflozin is a stable, reversible, highly selective, and orally active inhibitor of human renal sodium glucose co-transporter 2 (SGLT2), the major transporter responsible for glucose reabsorption in the kidney. Patients will receive one tablet dapagliflozin 10 mg per day for a total period of 14±1 days. This dose is the recommended dose for monotherapy and for add-on combination therapy with other glucose-lowering medicinal products including insulin to improve glycaemic control in T2DM.
15779173|NCT04620577|Other|antibiotic|normal saline
15779174|NCT04620551|Device|Sub-clinical stimulation|The third night of recording will involve sub-clinical thresholds of stimulation in all subjects.
15779175|NCT04620538|Diagnostic Test|Breath Analysis|Participants will be asked to provide 500mls of exhaled breath which will be loaded on to thermal desorption tubes and analysed via Mass Spectrometry.
15779176|NCT04620499|Device|EEG|PEER EEG
15779177|NCT04620486|Other|Epic Best Practice Alert|This is a customized Best Practice Alert created at Mass General Brigham in the institutional Epic electronic medical record system.
15779178|NCT04620473|Drug|Anlotinib+Capeox|to use Anlotinib hydrochloride combined with Capeox in the neoadjuvant treatment of locally advanced rectal cancer
15779179|NCT04620473|Drug|Capeox|to use Capeox in the neoadjuvant treatment of locally advanced rectal cancer
15779180|NCT04620460|Device|Low-intensity Focused Ultrasound(LIFUS)|Patients with schizophrenia will be treated with active LIFUS or sham stimulation for 3 weeks on the left DLPFC.
15779181|NCT04620447|Other|Intelligent Virtual Reality Therapy System (IVRTS)|The approach of the Novel Intelligent Software interface approaches follows the basic premise that human beings think in terms of images rather than words. While the existing modes of treatment for phobias rely mainly on talk therapies and counseling; This novel intelligent software treatment methodology deals with the development of VR programs integrated with hardware for simulating various phobia-inducing situations, followed by novel automated integrated most effective psychotherapy; altering these images to reduce the anxiety experienced. Our treatment package includes a VR device integrated with easily comprehensible voice commands, along with a user manual and easy user interface, thereby reducing the effort of training required for operating the device. The framework is a combination of the therapy methodologies with VR, motion sensors and biofeedback.
15779182|NCT04620434|Device|Video laryngoscopic view|The glottic view on the screen of the video laryngoscope during laryngoscopy with a C-MAC video laryngoscope, which installed with Macintosh blade.
15779183|NCT04620434|Device|Direct laryngoscopic view|The glottic view evaluated by the anesthesiologist who performing tracheal intubation, by direct laryngoscopy with C-MAC installed with Macintosh blade.
15779184|NCT04620421|Other|Rhythm-based Multitask Training|Participants will be assigned to a weekly one-hour RYMA session for six months, followed by a six-month follow-up period without training. An experienced instructor will perform the RYMA sessions, which consists of a wide variety of rhythm-based multitask exercises performed to improvised piano music. The RYMA intervention is inspired by Dalcroze eurhythmics and exercises consists of components such as 1) coordination between hands and/or feet, 2) dissociation between hands and/or feet, 3) movements based on musical cues (e.g. follow the tempo), 4) movement inhibition based on musical cues, 5) handling of props (e.g. balls, scarfs, and plates), 6) pair or group-based coordination movements (e.g. clapping each other's hands and mirroring movements), 7) memorizing and repeating of rhythmic patterns, and 8) quick motoric responses to unexpected cues.
15779185|NCT04620408|Drug|SHR4640|Subjects were randomly divided into the group A, B. On D1, D8, two groups of subjects were respectively given SHR4640 tablet.
15779186|NCT04620395|Diagnostic Test|Punch biopsy|A standardized biopsy kit is used for a synovial fluid tap and subsequent acquisition of up to 7 Punch biopsies through an introducer (part of the kit)
15779187|NCT04620382|Drug|Midodrine|Midodrine 5-10 mg, single oral dose
15779188|NCT04620382|Drug|Placebo pill|single oral dose
15779189|NCT04620382|Device|Abdominal compression|abdominal compression up to 40 mmHg during head-up tilt
15779190|NCT04620382|Device|sham compression|Sham abdominal compression during head-up tilt
15779191|NCT04620369|Drug|Placebo Administration|Instill isotonic nasal saline intranasally
15779192|NCT04620369|Other|Questionnaire Administration|Ancillary studies
15779193|NCT04620369|Drug|Rose Geranium in Sesame Oil Nasal Spray|Instill intranasally
15779194|NCT04620356|Device|DryNites Pyjama Pants|DryNites Pyjama Pants are disposable, absorbent youth pants designed to help children manage bed wetting by absorbing involuntary urine loss and protecting the child's garments and bedding. DryNites Pyjama Pants are underwear-like alternatives that can be discreetly worn beneath pyjamas or nightwear during the bedwetting phase.
15779195|NCT04620343|Procedure|A: Breathing advice with bio-feedback|Information and breathing advice with biofeedback will serve as an active comparator in this study, and time allowed for IBA and biofeedback in this study will be max 30 min. The teaching will be provided by the attending physician and the test leader. The session will follow a strict checklist. After the laryngoscope has been secured in correct position the patient will be shown his/her larynx on the screen, providing the patient with basic knowledge on laryngeal anatomy and function in a calm atmosphere before the CLE-test. After, the patients will be trained to make any symptoms abate, and a good breathing posture and how to optimally use their breathing muscles.
15779196|NCT04620343|Procedure|B: Breathing advice with bio-feedback, Inspiratory muscle training (IMT)|Breathing advise and IMT. The inspiratory muscle training (IMT) will build on the information the patients have obtained during the IBA and biofeedback session. The IMT will focus on training endurance and coordination of the PCA muscle, aiming to reduce fatigue of the abducting capacity of the larynx and to enhance coordination and create a sense of laryngeal control. When performing the IMT sessions, it is of utmost importance that a functional diaphragmatic breathing pattern has been established, and that this breathing pattern is maintained throughout all the IMT sessions. Once the patient has demonstrated that he/she is able to perform breathing according to these principles, the IMT session will follow a detailed protocol while wearing a flexible laryngoscope and settings and techniques are adjusted to ensure max open larynx. The patient will perform IMT training at home as instructed and have video meetings one and three weeks after initial training to observe progress.
15779197|NCT04620343|Procedure|C: Breathing advice with bio-feedback, Speech Therapy|The training period with the speech therapist takes three days, divided into 6 sessions. The training is continued at home, implementing the techniques during physical activity and at rest. The aim of the speech therapy is to help the patients to develop a strategy on how to control his/her larynx during exercise, and to be able to continue exercising without experiencing dramatic EILO incidents. They will be informed that the best approach is to start practicing while performing low to moderate intensity exercise, and then gradually increase the intensity as they become more confident. It will be emphasized that the new breathing technique they are about to adopt will need to be repeated until it becomes adapted as a part of their automated breathing pattern. Patients will be followed up with video meetings one and three weeks after initial training to observe progress.
15779198|NCT04620343|Procedure|D: Breathing advice with bio-feedback, IMT and Speech Therapy|All treatments as described above.
15779199|NCT04620343|Procedure|A: If CLE-test unchanged, additional IMT and Speech Therapy|All treatments as described above.
15779238|NCT04620135|Drug|Ripasudil hydrochloride hydrate ophthalmic solution 0.4%|Other Name: Glanatec®
15779239|NCT04620122|Other|Progressive Muscle Relaxation Training and Music Therapy|Progressive Muscle Relaxation Training and Music Therapy have applied to the participants two sessions for a week during two months.
15779240|NCT04620109|Drug|KDR2-2|"KDR2-2 is a synthetic anti-angiogenic chemical compound with highly effective inhibition on vascular endothelial growth factor receptor-2 (VEGFR2), and an additional, moderate inhibitory effect on platelet-derived growth factor receptor β (PDGFRβ).
~KDR2-2 suspension eye drop is in development for the treatment of corneal neovascularization."
15779241|NCT04620109|Drug|Placebo|Placebo : the formulation and the product process of placebo are the same as the KDR2-2 eye drops, but without API .
15779200|NCT04620343|Procedure|Surgery 1: Supraglottoplasty - full procedure under general anesthesia|Endoscopic supraglottoplasty with carbon dioxide laser and cold steel microlaryngeal instruments. The patient is intubated with an armored laser-tube which is positioned in the posterior midline to protect this area from laser injury. The laryngoscope is positioned into the vallecula and the surgery is visualized through an operation-microscope. CO2-laser beams of 2-4W focused with micro spot is utilized. Releasing incisions are made at the anterior border of both AEFs. The depth of the incisions are limited to the cranial border of the ventricular folds. The cuneiform tubercles including their surrounding mucosa are removed in a circular pattern before the two incisions are adjoined, thus creating a drop shaped excision. Care is taken to avoid scarring. It is recommended to protect the posterior commissure and the piriform sinus with wet tissue cloths. In case of perioperative edema of the laryngeal mucosa, corticosteroids are administrated to prevent laryngeal edema post-operatively.
15779201|NCT04620343|Procedure|Surgery 2: Supraglottoplasty - mini-invasive procedure under general anesthesia|"Endoscopic supraglottoplasty with carbon dioxide laser. The patients are intubated with an armored laser-tube, which is positioned in the posterior midline to protect this area from laser injury. The laryngoscope (Benjamin/Lindholm) is positioned into the vallecula and the surgery is visualized through an operation-microscope. CO2-laser beams of 2-4W focused with micro spot are utilized. Four punctures will be made along the lateral borders of both aryepiglottic folds bilateral, thus creating a row of small punctures parallel to the rim of the aryepiglottic folds. The punctions should not be deeper than the incision in the full procedure (above); i.e. less than 5 millimeter, and care must be taken to avoid heat affecting the nervus recurrens posteriorly. Care is taken to avoid scarring and collateral thermal injury. It is recommended to protect the posterior commissure and the piriform sinus with wet tissue cloths. No antibiotic prophylaxis is administered."
15779204|NCT04620317|Dietary Supplement|Synbiotic|10 billion (B) colony forming unit (CFU) of Lactobacillus plantarum LP01, Bifidobacterium lactis BB12, and inulin oligofructose
15779205|NCT04620317|Dietary Supplement|Placebo|Non-active ingredients - Maltodextrins
15779206|NCT04620304|Biological|UB-421 SC(dB4C7C22-6 mAb)|The UB-421 SC (dB4C7C22-6 mAb) will be supplied at a concentration of 125 mg/mL after reconstitution. Subjects will receive weekly UB-421 SC injections during the 4-week Treatment Period.
15779207|NCT04620291|Biological|UB-421 SC|The UB-421 SC (dB4C7C22-6 mAb) will be supplied at a concentration of 125 mg/mL after reconstitution. Subjects will receive weekly UB-421 SC injections during the 4-week Treatment Period.
15779208|NCT04620278|Genetic|DNA or RNA Sequencing|Samples will be used for whole exome (DNA) or RNA sequencing
15779209|NCT04620265|Other|Antigravity treadmill training 100% weight bearing|This group received antigravity treadmill training 100% weight bearing and conventional exercise program.
15779210|NCT04620265|Other|Antigravity treadmill training 75% weight bearing|This group received antigravity treadmill training 75% weight bearing and conventional exercise program.
15779211|NCT04620265|Other|Antigravity treadmill training 50% weight bearing|This group received antigravity treadmill training 50% weight bearing and conventional exercise program.
15779212|NCT04620265|Other|Antigravity treadmill training 25% weight bearing|This group received antigravity treadmill training 25% weight bearing and conventional exercise program.
15779213|NCT04620265|Other|The conventional exercise program|This group received the conventional exercise program only.
15779214|NCT04620252|Drug|Inactive supplement|Chewable candy used as a negative control in this arm of the study, which will be chewed for 1 minute.
15779215|NCT04620252|Drug|Tricalcium phosphate supplement|Chewable tricalcium phosphate supplement, to be chewed for 1 minute.
15779216|NCT04620252|Drug|Calcium carbonate supplement|Chewable calcium carbonate supplement, to be chewed for 1 minute.
15779217|NCT04620252|Drug|Calcium citrate supplement|Chewable calcium citrate supplement, to be chewed for 1 minute.
15779218|NCT04620252|Drug|Fluoride mouthwash|Over the counter sodium fluoride mouthwash, at a concentration of 0.05% (226 parts per millim (ppm) of fluoride), to be used for 1 minute and then expectorated.
15779219|NCT04620252|Drug|Calcium supplement and fluoride mouthwash|A calcium supplement sill be chewed for 1 minute, immediately followed by a 1 minute rinse with an over the counter sodium fluoride mouthwash, at a concentration of 0.05% (226 parts per millim (ppm) of fluoride).
15779221|NCT04620226|Other|Quality Improvement|Rapid Point-of-Care testing will provide participants with a HCV antibody and RNA result within 2 hours. If the participant is HCV RNA+, they will receive an inpatient consultation from a liver specialist prior to discharge. We hypothesize that this model will minimize losses in the continuum-of-care and improve linkages to care.
15779222|NCT04620213|Drug|Phentolamine Ophthalmic Solution 0.75%|0.75% phentolamine ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
15779223|NCT04620213|Other|Phentolamine Ophthalmic Solution Vehicle (Placebo)|Topical sterile ophthalmic solution
15779224|NCT04620200|Drug|Nivolumab|3mg/kg
15779225|NCT04620200|Drug|Ipilimumab|1mg/kg
15779226|NCT04620187|Drug|Ado-trastuzumab (T) emtansine (T-DM1)|Intravenous infusion ever 21 days (3weeks) for 1 year (52 weeks)
15779227|NCT04620187|Radiation|Standard of Care Radiotherapy|Radiotherapy to shrink or kill tumors
15779228|NCT04620187|Drug|Standard of Care Chemotherapy|Intravenous injection
15779229|NCT04620174|Other|Custom-made zirconia crowns|Ten decayed primary molars will be restored with custom-made zirconia crowns.
15779230|NCT04620174|Other|Prefabricated zirconia crowns|Ten decayed primary molars will be restored with prefabricated zirconia crowns.
15779231|NCT04620161|Drug|Pradigastat Tablets 20mg|20mg, once daily, oral administration
15779232|NCT04620161|Drug|Pradigastat Tablets 40mg|40mg, once daily, oral administration
15779233|NCT04620161|Drug|Pradigastat Tablets 20mg matching Placebo|once daily, oral administration
15779234|NCT04620161|Drug|Pradigastat Tablets 40mg matching Placebo|once daily, oral administration
15779235|NCT04620148|Drug|TAK-242|TAK-242 concentrate solution 80 mg/mL for dilution and infusion
15779242|NCT04620083|Other|Integrative Learning Program for Old People with Dementia|The program included modalities for reality orientation, daily living skills training, reminiscence therapy, multisensory stimulation, fall prevention program, mindfulness activities, Meridian exercise, brain health program (Four Arts of the Chinese Scholar which referred to zither, go, calligraphy and painting) and health education. It was also agreed that case managers, caregivers, and participants were free to choose these treatments or could be assigned to a treatment regime on a 'mix and match' basis to suit their personality traits for improving their abilities to meet their own needs. This program was developed by the team using Delphi technique.
15779243|NCT04620070|Procedure|ECPR|Application of prehospital ECPR
15779244|NCT04620057|Dietary Supplement|butyrate|sodium butyrate (20 mg/kg body weight/day)
15779245|NCT04620057|Other|placebo|cornstarch
15779246|NCT04620044|Other|Kaledo game|Before starting the study, the height and weight of the children in the play group were measured and their body mass indexes were calculated. Personal information form, nutrition self-efficacy scale, nutrition attitude scale and nutrition behavior scale were applied.Then the game sessions were started.Game sessions lasted 12 weeks. After 12 weeks, the height and weight measurements of the students were made and their body mass indexes were calculated. Personal information form, nutrition self-efficacy scale, nutrition attitude scale and nutrition behavior scale were applied.
15779247|NCT04620044|Other|Education|Before starting the study, the height and weight of the children in the education group were measured and their body mass indexes were calculated. Personal information form, nutrition self-efficacy scale, nutrition attitude scale and nutrition behavior scale were applied.Then the education sessions were started.education sessions lasted 12 weeks. After 12 weeks, the height and weight measurements of the students were made and their body mass indexes were calculated. Personal information form, nutrition self-efficacy scale, nutrition attitude scale and nutrition behavior scale were applied.
15779248|NCT04620044|Other|No intervention|Body mass indexes were calculated by measuring the height and weight of the students.Personal information form, nutrition self-efficacy scale, nutrition attitude scale and nutrition behavior scale were applied.The same measurements and scale applications were repeated after 12 weeks.
15779249|NCT04620031|Drug|HSK3486|Loading Dose：0.1 mg/kg, infused with 4 min ± 30 s； Maintenance Dose：Maintenance is started at 0.3 mg/kg/h, and the dose can be adjusted up and down by 0.05-0.1 mg/kg/h. Range of maintenance dose: 0.06-0.8 mg/kg/h
15779250|NCT04620031|Drug|Propofol|"Loading Dose：0.5 mg/kg, infused with 4 min ± 30 s
~Maintenance Dose：Maintenance is started at 1.5 mg/kg/h, and the dose can be adjusted up and down by 0.25-0.5 mg/kg/h. Range of maintenance dose:
~0.3-4 mg/kg/h"
15779251|NCT04620018|Drug|Amoxicillin|Subjects received Amoxicillin before surgery, before and after surgery ,and only after surgery.
15779252|NCT04620005|Other|Observational|Survey
15779253|NCT04619979|Procedure|total knee arthroplasty|perform total knee arthroplasty for patients
15779254|NCT04619953|Other|Dynamic Postural Stability Training|The dynamic postural stability training, will consist of marching on unstable surface and on treadmill both with open and with closed eyes.
15779255|NCT04619953|Other|Cognitive-Motor Training|The cognitive-motor training consisted of a dual task paradigm: each patient was asked to walk without stopping and was explained that, during the task, they might hear a sound, and in that case, they should have look at the stimulus 'side and recognize a visual target. This dual task was performed both marching on an unstable surface and marching on treadmill.
15779256|NCT04619953|Other|Conventional Therapy|The conventional neuromotor rehabilitation will consist in muscles stretching, active-assisted mobilizations, neuromuscular facilitations, gait training and balance exercises using swinging platforms
15779257|NCT04619940|Diagnostic Test|iHandy application|The IHandy® app is a free app with a visual display similar to that of the digital inclinometer in terms of digital size. In this study, due to its prevalence in the literature and its use in clinics, manual goniometer (gold standard) was chosen to be compared with this iPhone application.
15779258|NCT04619940|Diagnostic Test|Standard Goniometer|While measuring with goniometer, the pivot point of the goniometer was placed on the olecranon, the immobile rod of the goniometer was kept parallel to the bed, while the moving rod was kept parallel to the ulna, the angle was recorded at the end point of the movement.
15779259|NCT04619927|Genetic|Direct CYP2C19 genotyping|CYP2C19 genotype will be determined by the Spartan RX CYP2C19 point-of-care system.
15779260|NCT04619927|Genetic|CYP2C19 genotyping at the end of the study|Blood-based CYP2C19 genotyping will be performed at the end of the study
15779261|NCT04619927|Drug|Poor metabolisers|Acetylsalicylic acid 100mg once daily plus rivaroxaban 2.5mg twice daily
15779262|NCT04619927|Drug|Intermediate metabolisers|Clopidogrel 75mg twice daily
15779263|NCT04619927|Drug|Normal metabolisers and unknown metaboliser state|Clopidogrel 75mg once daily
15779264|NCT04619914|Drug|Clomid; Aventis pharma S.AE, Global Napi pharmaceuticals, Cairo, Egypt|CLOMID (clomiphene citrate tablets USP) is an orally administered, nonsteroidal, ovulatory stimulant designated chemically as 2-[p-(2-chloro-1,2-diphenylvinyl)phenoxy] triethylamine citrate (1:1)
15779265|NCT04619914|Drug|letrozole (Femara; Novartis pharma AG, Basle, Switzerland)|Letrozole, or CGS 20267, is an oral non-steroidal type II aromatase inhibitor. It is a third generation aromatase inhibitor like exemestane and anastrozole, meaning it does not significantly affect cortisol, aldosterone, and thyroxine.
15779266|NCT04619901|Other|Semi-structured interviews|Exploring the psychological and social impact on parents of a palliative care decision concerning their child in the neonatal period
15779267|NCT04619901|Other|Questionnaire|Assessing the neuro-developmental evolution of children and understanding the determinants of the psychological and social impact of palliative care decisions on parents
15779268|NCT04619901|Other|following Scales|Scales : Hospital Anxiety and Depression, Intolerance to Uncertainty, and Brief COPE.
15779269|NCT04619888|Diagnostic Test|HeartLogic|In case of HeartLogic index ≥16, the investigator will contact the patient to assess the patient's clinical condition and possibly adjust the heart failure treatment. The management will be standardized across centers according to the Manage-HF protocol.
15779270|NCT04619875|Other|KB5|KB5, a novel glycan, is a Kaleido laboratory code for KB174
15779271|NCT04619875|Other|SG1|SG1 is a novel glycan
15779272|NCT04619875|Other|Lactulose|Lactulose is a synthetic dissacharide
15779273|NCT04619862|Drug|Gabapentin|See arm descriptions
15779274|NCT04619862|Drug|Placebo|See arm descriptions
15779276|NCT04619849|Diagnostic Test|Palmaris Longus Test|Schaffer test will be done to understand the presence of palmaris longus. 4 different tests will be done to prove its absence.
15779277|NCT04619823|Other|Blood sample collection|Blood sample collection Mosquito collection at home
15779278|NCT04619810|Other|Nurse intervention program|Implementation of a specific care program for patients receiving immunotherapy for lung cancer
15779279|NCT04619797|Drug|Tiragolumab|Tiragolumab at a fixed dose of 600 milligrams (mg), administered by intravenous (IV) infusion, every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
15779280|NCT04619797|Drug|Atezolizumab|Atezolizumab at a fixed dose of 1200 mg, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
15779281|NCT04619797|Drug|Pemetrexed|Pemetrexed 500 milligrams per square meter (mg/m^2), administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
15779282|NCT04619797|Drug|Carboplatin|Carboplatin at dose of area under the concentration-time curve (AUC) of 5, administered by IV infusion, Q3W on Day 1 of each 21-day cycle for 4 cycles.
15779283|NCT04619797|Drug|Cisplatin|Cisplatin 75 mg/m^2, administered by IV infusion, Q3W on Day 1 of each 21-day cycle for 4 cycles.
15779284|NCT04619797|Drug|Tiragolumab Matching Placebo|Matching placebo, administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
15779285|NCT04619797|Drug|Pembrolizumab|Pembrolizumab at a fixed dose of 200 mg, administered by IV infusion, Q3W, on Day 1 of each 21-day cycle.
15779286|NCT04619784|Other|Pilates Exercises|Patients will receive 12 sessions of pilates.
15779287|NCT04619784|Other|control|Their routine medical treatments were continued
15779288|NCT04619771|Behavioral|Cognitive Behavioral Therapy for Insomnia|CBT-I has a specific protocol with behavioral targets that differ significantly from standard CBT. This approach focuses on implementing sleep restriction and stimulus control interventions which are fully deployed during the first session. 5 CBT-I sessions will be delivered over the course of 8 weeks. Key recommendations include: 1) reduce time in bed; 2) get up at the same time every day; 3) do not go to bed unless sleepy; 4) do not stay in bed awake for more than 15 minutes; and 5) avoid napping. Participants are also taught relaxation strategies and cognitive therapy addresses arousal and catastrophizing.
15779289|NCT04619758|Other|Emollient (sunflower oil)|In group A, mothers will be advised to massage their babies with sunflower oil at a dose of 10 mL/kg/day twice a day in equally divided amounts. They will be called for follow up after six months of application of sunflower oil.
15779290|NCT04619745|Other|Individualized Home and Play-Based Physical Activity Plans|Play-based, parent led interventions optimized to support age appropriate physical activity, and motor skills among young children with congenital heart defects.
15779291|NCT04619732|Diagnostic Test|Monitoring biochemical concentrations during cold machine perfusion|Three microdialysis probes will be introduced into the kidney tissues, the vein and ureter in order to measure creatinine, glucose and lactate while the organ is undergoing cold perfusion prior to transplantation.
15779292|NCT04619719|Device|Hyperbaric Oxygen Therapy (HBOT)|Patients assigned to the treatment arm will receive up to 5 treatments of hyperbaric oxygen therapy administered daily at 2.0 atmospheres for 90 minutes per session.
15779293|NCT04619706|Drug|FSD201|Tablets for oral administration.
15779294|NCT04619706|Drug|Placebo|Placebo tablets matched to FSD201 for oral administration.
15779297|NCT04619667|Device|High Flow Nasal Cannula (HFNC)|HFNC will be set at 30 L/min, with a temperature at 31° C and 100% of relative humidity
15779298|NCT04619667|Device|Continuous Positive Airway Pressure (CPAP)|"CPAP will be delivered through a helmet (Castar Next, Intersurgical S.p.A., Mirandola, Italy), with an adjustable Positive End-Expiratory Pressure (PEEP) valve (2.5-20 cmH2O) set at 10 cmH2O (Intersurgical S.p.A., Mirandola, Italy). The helmet will be connected to a turbine-driven ventilator (Monnal T60, Air Liquide Medical Systems, Antony, France) set to deliver oxygen-air admixture at a continuous flow rate of 60 L/min, in order to improve CO2 wash out. No heated humidification will be applied to avoid the fog effect in the helmet"
15779299|NCT04619654|Procedure|Cataract surgery with implantation of trifocal IOL combined with trabecular scaffold|Cataract surgery with implantation of the PanOptix IOL combined with minimally invasive glaucoma surgery utilizing the Hydrus Microstent
15779300|NCT04619641|Device|High Flow Nasal Cannula (HFNC)|HFNC will be set at 30 L/min, with a temperature at 31° C and 100% of relative humidity
15779301|NCT04619641|Device|Continuous Positive Airway Pressure (CPAP)|"CPAP will be delivered through a helmet (Castar Next, Intersurgical S.p.A., Mirandola, Italy), with an adjustable Positive End-Expiratory Pressure (PEEP) valve (2.5-20 cmH2O) set at 10 cmH2O (Intersurgical S.p.A., Mirandola, Italy). The helmet will be connected to a turbine-driven ventilator (Monnal T60, Air Liquide Medical Systems, Antony, France) set to deliver oxygen-air admixture at a continuous flow rate of 60 L/min, in order to improve CO2 wash out. No heated humidification will be applied to avoid the fog effect in the helmet"
15779302|NCT04619628|Biological|COVI-VAC|intranasal, live attenuated vaccine against SARS-CoV-2
15779303|NCT04619628|Other|Placebo|normal saline
15779304|NCT04619615|Other|Asynchronous self-directed digital training|Resident participants will be able to complete the digital training at their own pace.
15779305|NCT04619615|Other|Synchronous large group online workshop|Resident participants will complete the digital training platform in real time over the course of a one day, live workshop (4.5 hours of online instruction).
15779306|NCT04619602|Drug|GSNO|Intervention will be 30 minutes of inhaled GSNO agent in enrollment blocks of three subjects/dose (0.5 mL/kg of 0.25 mM, 0.5 mM, or 1 mM) to infants.
15779307|NCT04619576|Behavioral|Occupational health workers|Questionnaire online
15779308|NCT04619563|Drug|Anlotinib Hydrochloride plus Docetaxel|Anlotinib Hydrochloride (12mg, QD PO d1-14, 21days per cycle) and Docetaxel (75mg/m2 IV d1)
15779309|NCT04619550|Other|High tibial osteotomy|Realignment surgery
15779310|NCT04619537|Drug|Anlotinib Hydrochloride plus Docetaxel|Anlotinib Hydrochloride (12mg, QD PO d1-14, 21days per cycle) and Docetaxel (75mg/m2 IV d1)
15779311|NCT04619524|Diagnostic Test|Cervical mucus will be collected from patients undergoing IVF|Patients undergoing hormonal stimulation for IVF will be sampled for cervical mucus.
15779335|NCT04619329|Procedure|Surgical Resection|Surgical Resection of HCC
15779336|NCT04619316|Drug|Trametinib 2 MG [Mekinist]|Monotherapy with Trametinib is given in patients with BRAF wildtype.
15779312|NCT04619524|Diagnostic Test|Cervical mucus will be collected from patients undergoing transfer of cryopreserved embryos|Patients undergoing hormonal substitution for transfer of cryopreserved embryos will be sampled for cervical mucus.
15779313|NCT04619498|Device|PediAppRREST|PediAppRREST is a new audiovisual interactive app for tablets developed to support the management of pediatric cardiac arrest. It sequentially displays directions on recommended management interventions. It was specifically designed to guide the team leader to perform resuscitation interventions in the sequence/timing and modality reported by the American Heart Association Pediatric Advanced Life Support (AHA-PALS) guidelines.
15779314|NCT04619498|Other|AHA-PALS pocket reference card|It is a 10 cm x 16.5 cm, full-color, 2-sided, 6-panel card that shows the American Heart Association Pediatric Advanced Life Support (AHA-PALS) treatment algorithms. By providing a quick reference tool, it serves as a cognitive aid for healthcare providers who either direct or participate in the management of pediatric respiratory and/or cardiovascular emergencies, including cardiac arrest.
15779315|NCT04619485|Device|CO2 LASER|5 SESSIONS OF CO2 VAGINAL LASER
15779316|NCT04619485|Device|CO2 SHAM LASER|5 SESSIONS OF CO2 VAGINAL SHAM LASER
15779318|NCT04619459|Other|Kangaroo Mother Care (KMC)|Kangaroo mother care is a method of care of infants. The method involves infants being carried, usually by the mother, with skin-to-skin contact. Kangaroo mother care (KMC). early after delivery have better success at breastfeeding and achieve this success sooner. In this method The newborns' diapers were tied, their caps put on and then they were positioned on their mother's naked chest for KMC. The KMC session was continued for 3 hours.
15779319|NCT04619446|Device|Removable Twin Block|Twin block appliance (RFA) was introduced by William Clark in 1988. Many modifications for this appliance have been introduced lately. It has been named twin block for the characteristic of two unattached maxillary and mandibular plates with acrylic bite blocks, which makes 70o angle when come in contact with each other. Delta clasps are added for better retention of the appliance. This appliance plays a vital role in the treatment of mandibular retrognathia
15779320|NCT04619446|Device|Fixed Functional , AdvanSync Appliance|AdvanSync2 (Ormco Co., Glendora, Calif) is a FFA being introduced recently as an advancement of Herbst appliance. It is a molar-to-molar appliance, connected by a telescopic rod, which allow for simultaneous treatment with braces. It is much smaller in size than the conventional Herbst appliance and reduces treatment duration up to six to nine months. It is much more acceptable by the patients as they complain less about sores and discomfort, and is esthetically pleasant since it's not visible in the mouth. Short arms of this appliance help to decrease irritation and discomfort of the patient, and helps to advance the mandible in a constant forward direction to encourage growth, and reduce malocclusion.
15779321|NCT04619433|Drug|Camrelizumab;Pemetrexed and Carboplatin; Famitinib;|"Part 1:
~Drug: Camrelizumab; Pemetrexed; Carboplatin; Famitinib
~Part 2:
~Drug: Camrelizumab; Pemetrexed; Carboplatin; Famitinib"
15779322|NCT04619433|Drug|Camrelizumab;Pemetrexed and Carboplatin;Placebo|"Part 2:
~Drug: Camrelizumab; Pemetrexed; Carboplatin; Placebo"
15779325|NCT04619407|Diagnostic Test|Nasopharyngeal swab|SARS-CoV-2 PCR
15779326|NCT04619407|Diagnostic Test|Serum testing|Anti-SARS-CoV-2 antibody testing (IgA and IgG ELISA)
15779327|NCT04619394|Other|Aquatic exercise - own monitors program|"Supervision of own exercises by the Monitor with its own program. Two weekly sessions, both aquatic in small glass and large. The activity carried out will be aerobic; They will work with their own body weight and the lightweight floating material they offer in these pools. Exercises will be carried out that favor flexibility, elasticity, resistance and the strengthening of the muscular ligaments. The intensity of the exercises will be moderate and adapted in each month of gestation. We will eliminate positions and exercises that overload the pregnant woman, avoiding possible injuries and obstetric alterations.
~The start of the program will be established in week 10-12 of the pregnancy and the end in week 37-41.
~The total number of sessions of the program will be from 25 to 31 (28 sessions of minimum compliance), with a frequency of 2 sessions per week. The duration of these will be 50 minutes and adherence to both experimental groups of ≥28 classes."
15779328|NCT04619394|Other|Aquatic exercise - AIPAP program|"Supervised by a midwife with AIPAP method. AIPAP method is divided into 10 sessions of 50 minutes that are repeated cyclically with a total of 120 exercises. The sessions are divided into 5 groups with different objectives: 2 sessions of aerobic capacity improvement, 2 sessions of strength improvement, 2 sessions of pelvic elasticity, 2 coordination sessions and the last 4 sessions of the previous ones.
~The beginning of the program will be established in week 10-12 of pregnancy and the end in week 37-41.
~The total number of sessions of the program will be 25-31 (28 sessions of minimum compliance), with a frequency of 2 sessions per week. The duration of these will be 50 minutes in both experimental groups. It will be necessary to obtain an adherence to both experimental groups of ≥28 classes."
15779329|NCT04619381|Behavioral|CORONARY ARTERY DISEASE AND CLOPIDOGREL: PATIENT SURVEY|Survey is a non-standardized assessment of demographics, medication compliance and reasons for non- compliance.
15779330|NCT04619368|Other|Follow up calls|The follow-up will consist in phone call with an intensive care doctor. These visits would be the opportunity to screen the complications after intensive-care with, find solutions to cure them or decrease their impact on patient's life to improve quality of life and prevent the post-traumatic syndrome disorder PTSD. A review would be sent to the patients' General Practitioners at the end of each visit.
15779331|NCT04619355|Device|NIRS-IVUS|Near-infrared spectroscopy-intravascular ultrasound can be implemented in parallel with intravascular ultrasound and provides important information for predicting prognosis by measuring the lipid component of atherosclerotic plaques.
15779332|NCT04619342|Device|GSMs-TACE|TACE using epirubicin (30-40mg/m2) and gelatin sponge microspheres (150-350μm or 350-560μm)
15779333|NCT04619342|Procedure|Surgical Resection|Surgical Resection of PVTT
15779334|NCT04619329|Device|GSMs-TACE|TACE using Lobaplatin (30-40mg/m2) and gelatin sponge microspheres (150-350μm, 350-560μm, 560-710μm or 710-1000μm)
15779337|NCT04619316|Drug|Trametinib 2 MG [Mekinist] and Dabrafenib 75 MG (2-0-2) [Tafinlar]|Combination therapy is given in patients with BRAF V600E mutation.
15779338|NCT04619303|Drug|Dexamethasone intravitreal implant|Intravitreal injection of 0.7mg dexamethasone implant
15779339|NCT04619303|Drug|Bevacizumab Injectable Product|Invtravitreal injection of 1.25mg/0.05mL bevacizumab
15779340|NCT04619290|Drug|Sublingual Methylene blue|Patients will be received the treatment as follow: it will be placed Low Level Light Therapy (LLLT) NocUlite on the ventral side of the wrist on full power. Draw out 1ml of diluted Prexablu into a syringe. Activate this syringe LLLT device for 10 minutes. Then place 1ml of this activated solution of Prexablu sublingually. Patients must keep the solution under the tongue for 10 minutes before swallowing. Keep wrist pads on patients for 50 minutes.
15779341|NCT04619290|Other|Control patients|Control patients will be received the conventional treatment that may include analgesic, anti-inflammatory, antibiotic, steroid, antiplatelet, and anticoagulant.
15779342|NCT04619277|Device|drug-coated balloon|drug-coated balloon
15779343|NCT04619264|Drug|Papacarie|First, tooth was cleaned with a wet cotton pellet. The gel was inserted using disposable syringe tip into the cavity and its color changed from clear to cloudy indicating the presence of infected tissues. After 40 seconds, the softened carious tissue was removed using excavator by gentle pressure. The remaining gel was removed with a cotton pellet. The procedure was repeated until there was no change in the gel color indicating that there was no more infected tissue.
15779344|NCT04619264|Procedure|Atraumatic Restorative Treatment|The tooth was cleaned with a wet cotton pellet to remove debris and plaque and then isolated with cotton rolls to promote a dry environment. Caries was removed using a sharp excavator and the cavity was cleaned using a small wet cotton pellet and dried with a dry cotton pellet.
15779345|NCT04619251|Drug|BI 1323495|BI 1323495
15779346|NCT04619251|Drug|Placebo|Placebo
15779347|NCT04619251|Drug|Itraconazole|Itraconazole
15779348|NCT04619238|Diagnostic Test|King's Health Questionnaire|patients fulfilled questionnaire
15779349|NCT04619238|Diagnostic Test|the International Consultation on Incontinence Modular Questionnaire (ICIQ-SF) Short Form|patients fulfilled ICIQ-SF questionnaire
15779351|NCT04619212|Device|breast pumping as per SoC but on new software for the pump|breast pumping as per SoC but on new software for the pump
15779353|NCT04619173|Other|Thoracic manipulation|hot pack ,transcutaneous electrical nerve stimulation and manipulation along with stretching'
15779354|NCT04619173|Other|Conventional physical therapy Program|hot pack ,transcutaneous electrical nerve stimulation and stretching
15779355|NCT04619160|Drug|Propofol|TCI 4 µg/mL start until BIS-value of 50
15779356|NCT04619160|Drug|Sevoflurane|start 1 MAC, until BIS-value of 50
15779357|NCT04619147|Other|No intervention|This is descriptive, retrospective study to evaluate the epidemiology of invasive fungal infections (IFI) in patients undergoing allogeneic haematopoiectic stem cell transplant in the era of antifungal prophylaxis with posaconazole delay-released tablets.
15779358|NCT04619134|Other|NCSR Program|flexibility exercise,strengthening exercise,dynamic strengthening exercise,endurance training,counselling session
15779359|NCT04619134|Other|conventional physical therapy|hot pack,flexibility training,strengthening exercise.
15779360|NCT04619121|Device|NIR-tPBM|The treatment will last for 8 weeks and be bilateral and applied to the frontal areas with one application site on the left side and one on the right side (left and right forehead centered on the frontal eminences and per EEG sites on F3 and F4). Energy is administered with a radiation wavelength of 830 nm. The duration of irradiation is 20 minutes at each application site (the 2 sites are irradiated at the same time which is equivalent to 20 minutes of total time). The treatment will follow these specifications: PBM (IR) irradiance of 33.2 mW/cm2, each treatment window area is 28.7 cm2; PBM (IR) fluence of up to 60 Joules/cm2; energy delivered per session per device up to 1.72 kJ for a total of up to 3.44 kJ.
15779361|NCT04619121|Device|Sham device|The sham device is completely identical in appearance, but only emits neglectable energy to the brain.
15779362|NCT04619108|Biological|Thrombosomes®|
15779363|NCT04619095|Dietary Supplement|Psyllium|See the information already included in the arm descriptions.
15779364|NCT04619095|Dietary Supplement|Placebo|See the information already included in the arm descriptions.
15779365|NCT04619082|Drug|Tenofovir alafenamide|Tenofovir alafenamide 25 mg once per day for one year
15779366|NCT04619069|Radiation|SBRT|SBRT to all sites of metastatic disease as seen on PSMA PET scan
15779367|NCT04619069|Drug|Hormone therapy|Intermittent Hormone Therapy per physician discretion (Min. 8 months)
15779368|NCT04619056|Combination Product|CEB-01 membrane loaded with SN-38|CEB-01 is a polymeric drug with a delivery system loaded with SN-38, and will be placed in the surgical bed at the time of tumor resection.
15779369|NCT04619043|Device|Ankle Orthotic|
15779370|NCT04619030|Other|Augmented Reality|The patient leaflet has an Augmented Reality model that appears out of the leaflet when viewed with a smartphone
15779371|NCT04619030|Other|Traditional leaflet|Traditional leaflet with no Augmented Reality capability
15779372|NCT04619017|Biological|Segmental allergen challenge|All subjects will undergo bronchoscopy with administration of standardized allergen extract to one segment of the lung.
15779373|NCT04619004|Drug|Patritumab Deruxtecan (Fixed dose)|Patritumab deruxtecan will be dosed at 5.6 mg/kg as an intravenous (IV) infusion administered on Day 1 of each 21-day cycle.
15779374|NCT04619004|Drug|Patritumab Deruxtecan (Up-Titration)|Patritumab deruxtecan will be dosed as an intravenous (IV) infusion administered at Cycle 1, 3.2 mg/kg; Cycle 2, 4.8 mg/kg; Cycle 3 and subsequent cycles, 6.4 mg/kg administered on Day 1 of each 21-day cycle.
15779375|NCT04618991|Other|Filling the Quebec Sleep Questionnaire|Filling the Quebec Sleep Questionnaire (QSQ) by the pre-surgery patient, then at 3 months post surgery and 1 year post surgery.
15779412|NCT04618744|Drug|ORMD-0801 (Insulin) capsule 8 mg BD|8 mg ORMD-0801, 1 capsule, twice a day, once in the morning and once in the evening.
15779376|NCT04618978|Procedure|PSG and actigraphy recording|"Gold standard: electromyographic recording of tibialis anterior muscle during full night polysomnography (PSG).
~The new generation actigraphs devices Actiwatch will be combined to PSG as a screening tool: MotionWatch will be placed on the dorsum of feet to record)."
15779377|NCT04618965|Drug|control group|Each patient will receive intrathecal hyperbaric bupivacaine 10 mg in 2.5 ml and 0.5 ml saline with 3 mL total volume. Continous 50 ml saline infusion for 10 min followed by 200 ml saline infusion till the end of surgery.
15779378|NCT04618965|Drug|Intrathecal dexmedetomidine|Each patient will receive dexmedetomidine 5 μg diluted in 0.5ml saline and hyperbaric Bupivacaine 10 mg in 2.5 ml with 3 mL total volume. Continous 50 ml saline infusion for 10 min followed by 200 ml saline infusion till the end of surgery.
15779379|NCT04618965|Drug|Intravenous dexmedetomidine|Each patient will receive intravenous dexmedetomidine started at a loading dose of 1 μg/kg diluted in 50 ml saline and administered within 10 min as a loading dose, followed by maintenance at a dose of 0.4 μg/kg/h diluted in 200 ml saline till the end of surgery and hyperbaric Bupivacaine 10 mg in 2.5 ml total volume.
15779380|NCT04618952|Drug|Calcium D|calcium D supplementation given to postmenopausal females
15779381|NCT04618952|Drug|Placebo|Placebo
15779382|NCT04618939|Biological|BR-TD-1001|0.5 mL, IM
15779383|NCT04618939|Biological|Td-pur inj|0.5 mL, IM
15779384|NCT04618926|Device|Device intubating Laryngeal Tube Suction Disposable|Resuscitation in covid 19 patients
15779385|NCT04618913|Drug|Apixaban|Anticoagulant
15779386|NCT04618913|Drug|Rivaroxaban|Anticoagulant
15779387|NCT04618913|Drug|Edoxaban|Edoxaban
15779388|NCT04618913|Drug|Dabigatran|Dabigatran
15779389|NCT04618913|Drug|VKA|Vitamin K antagonist
15779390|NCT04618913|Drug|LMWH|Low Molecular Weight Heparin
15779391|NCT04618900|Procedure|Sinus floor elevation with a grafting material|The use of grafting material for sinus floor elevation
15779392|NCT04618887|Procedure|pallidotomy|deep brain nuclei lesion of GPi
15779393|NCT04618887|Procedure|deep brain stimulation|deep brain stimulation of GPi
15779394|NCT04618874|Diagnostic Test|Rapid on-site evaluation|Rapid on site evaluation performed with an MGG quick stain (Bio-Optica, Milano, Italy).
15779395|NCT04618848|Diagnostic Test|Fingerstick blood draw|Each participant shall be pricked twice in order to perform CBC test
15779396|NCT04618835|Diagnostic Test|40-Steps-test|40 steps performed on the spot
15779397|NCT04618822|Behavioral|Teaching involving whole-body movements|The intervention consist of three 30 minutes sessions per week for eight weeks. Activities are conducted in small groups of six children and focus on the acquisition of letterforms, letter-sound correspondences and reading and spelling of short words. Activities involve whole-body movements and have been developed with the embodied learning theory in mind, linking movement closely to the learning content.
15779398|NCT04618822|Behavioral|Teaching involving hand movements|The intervention consist of three 30 minutes sessions per week for eight weeks. Activities are conducted in small groups of six children and focus on the acquisition of letterforms, letter-sound correspondences and reading and spelling of short words. Activities involve movements using hands and arms and have been developed with the embodied learning theory in mind, linking movement closely to the learning content.
15779399|NCT04618822|Behavioral|Teaching involving minimal motor movements (control)|The control condition consist of three 30 minutes sessions per week for eight weeks. Activities are conducted in groups of app. twelve children and focus on the acquisition of letterforms, letter-sound correspondences and reading and spelling of short words. Activities are completed seated on a chair using paper and pencil.
15779400|NCT04618809|Behavioral|Didactic Session|This session will include an overview of the approach to and management of older mGC patients patients through a case-based presentation.
15779401|NCT04618809|Behavioral|Comprehensive Geriatric Assessment, including an exploratory analysis to evaluate the use of fitness trackers for evaluation of functional status.|"The Comprehensive Geriatric Assessment (CGA) is a composite of assessment scales evaluating physical, psychological, and social well-being, and is the recommended tool for evaluating an older cancer patient and determining appropriateness of therapy.
~The patient will receive a FitBit TM to wear for 4 days. Number of steps/day will be recorded."
15779402|NCT04618796|Other|vaccine|Effect of COVID-19 pandemic on vaccination compliance among children attending Assiut University Children Hospital and what is the degree of that.
15779403|NCT04618783|Biological|Three doses of low-dosage investigational sIPV, vaccinated within one-month interval between doses|Antigen content: 7.5, 22.5, and 22.5 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose
15779404|NCT04618783|Biological|Three doses of medium-dosage investigational sIPV, vaccinated within one-month interval between doses|Antigen content: 15, 45, and 45 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose
15779405|NCT04618783|Biological|Three doses of high-dosage investigational sIPV, vaccinated within one-month interval between doses|Antigen content: 22.5, 67.5, and 67.5 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose
15779406|NCT04618783|Biological|Three doses of control wIPV, vaccinated within one-month interval between doses|Antigen content: 40, 8, and 32 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose
15779407|NCT04618783|Biological|Three doses of control sIPV, vaccinated within one-month interval between doses|Antigen content: 30, 32, and 45 D-antigen unite for type 1, 2, and 3 in 0.5 ml diluent per dose
15779409|NCT04618757|Behavioral|Hedonic Reward|A reimbursement credit for hedonic expenses worth up to $50 will be awarded to each participant if they log at least 10,000 daily steps on at least 20 days during the first 28 days of each calendar month on Fitbit activity trackers provided by the study.
15779410|NCT04618757|Behavioral|Cash Reward|A reimbursement credit for $50 in cash will be awarded to each participant if they log at least 10,000 daily steps on at least 20 days during the first 28 days of each calendar month on Fitbit activity trackers provided by the study.
15779411|NCT04618757|Device|Fitbit|Fitbit devices are wireless pedometers that track the steps of participants, and will be offered in conjunction with a tailored website with customized information for participants.
15779413|NCT04618744|Other|Placebo|Matching Placebo
15779414|NCT04618731|Diagnostic Test|caries prevalence def ,DMF|the examination will carried out on dental chair using diagnostic set
15779415|NCT04618718|Device|cerebral embolic protection during TAVR|The ProtEmbo system is an adjunctive device placed in the central arterial system at the beginning of a TAVR procedure to deflect embolic particles during the procedure and removed following the completion of the procedure.
15779417|NCT04618692|Other|Surgical Loupes|Biliary reconstruction will be performed using surgical loupe
15779418|NCT04618692|Other|Microscope|Biliary reconstruction will be performed using microscope
15779419|NCT04618666|Procedure|laparoscopic and open surgery intervention|laparoscopic and open surgery to remove an inflammed appendix in chronic appendicitis
15779420|NCT04618653|Other|assessment only|Three assessment will include computerized assessments, interviews, and subset will provide daily reports of prescribed AA behaviors and practices
15779421|NCT04618640|Biological|DTaP-IPV combination vaccine|Dosage and administration: A single intramuscular injection of 0.5 mL will be given to healthy children aged 4 to 6 years
15779422|NCT04618627|Other|lung ultrasound|Role of lung ultrasonography in prediction of the seveity and the need for surfactant administration in neonates with respiratory distress syndrome.
15779423|NCT04618614|Device|HD-tDCS 1 mA to S1|Anodal high definition transcranial direct current stimulation of the right primary somatosensory cortex with an intensity of 1 mA
15779424|NCT04618614|Device|HD-tDCS 1 mA to M1|Anodal high definition transcranial direct current stimulation of the right primary motor cortex with an intensity of 1 mA
15779425|NCT04618614|Device|Sham control|Sham stimulation of the right primary somatosensory cortex
15779426|NCT04618601|Drug|Spironolactone|Patients randomized to the high-dose spironolactone group will receive oral spironolactone (≥100 mg) on top of standard of care treatment for acute heart failure immediately after randomization and in the afternoon of each subsequent day unless the serum potassium level is >5 mmol/L. The exact dose will be determined based on a pre-specified algorithm provided.
15779427|NCT04618588|Procedure|Low Window Sinus Lift technique|"Preoperative CBCT of surgical site and Fabrication CAD/CAM surgical stent, Sinus elevation using Low Window Sinus Lift technique, Implant, bone graft and membrane placement"
15779428|NCT04618575|Drug|Ursodeoxycholic acid combined with total glucosides of paeony|Ursodeoxycholic acid combined with total glucosides of paeony
15779429|NCT04618575|Drug|Ursodeoxycholic acid only|Ursodeoxycholic acid only
15779430|NCT04618562|Other|Revival Active Program|Program comprised of physical activities, group play, mind games, reasoning and discussion on sleeted topics, breath work and relaxation techniques, 60 minutes all together.
15779431|NCT04618549|Procedure|Direct Anterior Approach Hemiarthroplasty|Hemiarthroplasty to elderly patients with femoral neck fracture through a direct anterior approach
15779432|NCT04618549|Procedure|Mini Posterior Approach|Hemiarthroplasty to elderly patients with femoral neck fracture through a mini posterior approach
15779433|NCT04618549|Procedure|Lateral approach|Hemiarthroplasty to elderly patients with femoral neck fracture through a lateral approach (Hardinge)
15779434|NCT04618536|Other|Inorganic sunscreen|Inorganic sunscreen will be applied evenly to 2 areas on the back of the subject with a 1 cc syringe and gloved finger in an amount of 2 mg / cm2. In the first session, one area will be irradiated 20 minutes after sunscreen application. In the second session, the other area will be irradiated after the subject has swam for 1.5 hours.
15779435|NCT04618536|Other|Organic sunscreen|Organic sunscreen will be applied evenly to 2 areas on the back of the subject with a 1 cc syringe and gloved finger in an amount of 2 mg / cm2. In the first session, one area will be irradiated 20 minutes after sunscreen application. In the second session, the other area will be irradiated after the subject has swam for 1.5 hours.
15779436|NCT04618523|Drug|Artesunate-amodiaquine|Artemisinin-based combination treatment
15779437|NCT04618523|Drug|Artemether-lumefantrine|Artemisinin-based combination treatment
15779438|NCT04618510|Device|SEED 1-dayPure EDOF soft contact lens|Centre-distance contact lens with peripheral add power working on extended depth of focus principle to control myopia
15779439|NCT04618510|Device|Single Vision Spectacles|These are the type of glasses that correct vision for a single distance
15779440|NCT04618497|Drug|Methoxyflurane|Each patient in the methoxyflurane group will use one Penthrox inhaler under supervision of trained personnel. After priming the inhaler with 3 mL of methoxyflurane, patient is instructed to inhale through the mouthpiece to obtain analgesia, and then exhale back into the mouthpiece so that any unmetabolized methoxyflurane can be adsorbed by activated charcoal chamber. First few breaths should be gentle and then breathe normally through Inhaler. Onset of pain relief is rapid and occurs after 6-10 inhalations. If stronger analgesia is required, patient can cover the diluter hole with a finger during inhalation. Patients are able to titrate the amount of methoxyflurane inhaled and should be instructed to inhale intermittently to achieve adequate pain control.
15779441|NCT04618497|Drug|Ketorolac|Each patient in the ketorolac group will receive one dose of 30mg intramuscular ketorolac injected at gluteal muscle by nursing staff as usual daily practice.
15779442|NCT04618484|Other|Biomodulation (non-pharmacological)|cryo-, photo- and electro-biomodulation
15779444|NCT04618458|Behavioral|Power to Prevent|Lifestyle diabetes prevention intervention based on the National Diabetes Prevention Program and tailored for African American families. The intervention will be delivered using telehealth and small group videoconferencing.
15779445|NCT04618445|Behavioral|some risk factors that might be correlated with TMD|Fonesca questionnaire
15779446|NCT04618419|Diagnostic Test|internal jugular vein distensibility index|It is a prospective observational clinical study to correlate hemodynamic monitoring between Electrical Cardiometry and internal jugular vein distensibility index by sonogram
15779447|NCT04618406|Device|PICO VAC|PICO14 device from Smith and Nephew - Off the shelf, disposable negative pressure wound therapy device. Contains sterile dressing as well as an attached small (pager-sized) suction device/canister and provides a negative pressure of -80 mmHg for 14 days.
15779448|NCT04618406|Other|Standard care|Sterile surgical silicone foam dressing and soft dressing applied immediately postoperative and removed after 12 days
15779449|NCT04618393|Biological|EMB-02|EMB-02 is a FIT-Ig® bispecific antibody against PD-1 and LAG-3.
15779450|NCT04618380|Diagnostic Test|bUD-VA,bUN-RA, bUI-RA, bUI-CPS, bUN-CPS, contrast sensitivity|"The following clinical indexes are evaluated:
~Binocular uncorrected distant visual acuity (bUD-VA) using the Greek version of the Early Treatment Diabetic Retinopathy Study Chart at four meters distance
~Binocular uncorrected reading acuity at 60cm (bUI-RA) and at 40cm (bUN-RA), and
~Binocular uncorrected critical print size at 60cm (bUI-CPS) and at 40cm (bUN-CPS).
~All near and intermediate vision parameters are obtained using the Democritus Digital Acuity Reading Test (DDART), which is based on the Greek version of MNREAD.
~Contrast sensitivity are evaluated with the Pelli-Robson test."
15779451|NCT04618367|Procedure|Hepatic arterial infusion chemotherapy|administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 6 weeks
15779452|NCT04618367|Drug|Lenvatinib|12 mg (or 8 mg) once daily (QD) oral dosing.
15779453|NCT04618367|Drug|Sintilimab|200mg intravenously every 3 weeks
15779454|NCT04618354|Other|No interventions|This clinical study is a retrospective study, and no interventions have been implemented for patients.
15779455|NCT04618328|Drug|all trans retinoic acid|ATRA is given concomitantly at a daily dose of 10 mg twice daily orally for 12 weeks
15779457|NCT04618289|Dietary Supplement|Vitamin D3-fortified fruit juice supplement|Vitamin D3-fortified fruit juice supplement
15779458|NCT04618276|Other|Photodynamic Therapy|PDT with two different photosensitizers
15779459|NCT04618263|Drug|GATE-101|GATE-101 is a metabotropic glutamate receptor type 2/3 antagonist
15779460|NCT04618250|Other|SOFIA model|A mandatory two day course for general practitioners assigned to the intervention group A prolonged consultation at the general practitioner Use of an individual care plan
15779461|NCT04618224|Diagnostic Test|DDART Testing|One randomly selected eye is included for each study participant. Participants respond to the DDART near vision test with defined environmental conditions at 40 cm viewing distance. All four parameters (RA, MRS, CPS and ACC) are evaluated.
15779462|NCT04618224|Diagnostic Test|wDDART Testing|One randomly selected eye is included for each study participant. Participants respond to the wDDART near vision test with defined environmental conditions at 40 cm viewing distance. All four parameters (RA, MRS, CPS and ACC) are evaluated.
15779463|NCT04618211|Drug|PHA-022121|PHA-022121 soft capsules for oral use (PHVS416)
15779464|NCT04618211|Drug|Placebo|Matching placebo capsules for oral use
15779465|NCT04618198|Other|Immediate anti-TB therapy|Study participants will receive immediate empiric anti-TB therapy
15779466|NCT04618198|Other|Sepsis-specific dose anti-TB therapy|Study participants will receive conventional WHO weight-based dose anti-TB therapy
15779467|NCT04618185|Diagnostic Test|Magnetic Resonance Imaging (MRI)|MRI to study gut function and transit without the risk of exposure to ionising radiation.
15779468|NCT04618172|Other|Aerobic exercise|30 minute long aerobic exercises twice a week
15779469|NCT04618159|Other|lactobacillus reuteri DSMZ 17648|to evaluate if this product can eradicate helicobacter pylori
15779470|NCT04618146|Drug|Morphine Sulfate|intrathecal low dose morphine for early return to normal activity without opioid related complications.
15779471|NCT04618146|Drug|Bupivacaine Hydrochloride|intrathecal bupivacaine 0.5%
15779472|NCT04618133|Behavioral|Early time-restricted eating|Participants will be advised to eat only during a selected window of 8 hours over the 24-hour cycle, i.e. from 6am to 2pm, with a 1-hour allowance according to their daily routine
15779473|NCT04618133|Behavioral|Late time-restricted eating|Participants will be advised to eat only during a selected window of 8 hours over the 24-hour cycle, i.e. from noon to 8pm, with a 1-hour allowance according to their daily routine
15779474|NCT04618133|Behavioral|Active control|Participants will be advised to eat a minimum of 3 meals over the 24-hour cycle, i.e. breakfast from 6am to 9am, lunch from 11am to 2pm, dinner from 6pm to 10pm. Snacks will be allowed between meals
15779475|NCT04618120|Other|Virtual reality-based exercise|"Virtual reality-based exercises with Microsoft Xbox 360 Kinect and breathing exercises.
~Patient education"
15779476|NCT04618120|Other|Exercise|Shoulder range of motion, stretching, posture and breathing exercises. Patient education
15779477|NCT04618107|Procedure|Wide awake surgery|Wide awake local anaesthesia was used to perform tendon repair surgeries.Local anaesthetic injections given using 27 gauze needle in subcutaneous tissue plane.Tendon repair performed using modified Kessler repair.Outcome of surgery assesed at sixth postoprative week.
15779478|NCT04618107|Procedure|General anaesthesia|Tendon repair performed under general anaesthesia using modified Kessler repair.Outcomes of surgery assesed at sixth post operative week
15779479|NCT04618094|Other|bicycle ergometer training with different intensities|Following a 10-min warm-up phase at a constant work load below ventilatory threshold, participants of the high intensity interval group perform repeated high intensity exercise bouts, followed by an active recovery on a bicycle ergometer. The comparative group perform a constant moderate intensity with the same mean workload. The cool-down phase is 5 min with a constant work load for both groups.
15779480|NCT04618055|Device|NiTiDent Tuah Porous NiTi Dental Implants|A newly developed NiTiDent Tuah porous NiTi cylindrical bone level dental implant measuring 4.5 mm in diameter and 10 mm in length and an abutment system of different heights and angulations produced by Nitium Technology Sdn Bhd.
15779481|NCT04618055|Device|Control Dental Implant Systems|A market approved bone level dental implant systems measuring 4.5 mm in diameter and 10 mm in length and an abutment system of different heights and angulations
15779482|NCT04618042|Drug|FX06|FX06 i.v.: 400 mg per day (divided in two injections) during 5 days
15779483|NCT04618042|Drug|Placebo of FX06|Placebo i.v.: 400 mg per day (divided in two injections) during 5 days
15779484|NCT04618029|Other|Home Modification|"Home Modification Intervention
~Floor
~Provide recommendations to:
~Fix the back of the rugs and mats with adhesive/heavy duty tape
~Buy non-slip mats
~Tie all cables with a proper cable tie
~Lighting
~Provide recommendations to:
~Buy a torch light
~To replace worn light bulbs
~Buy a light switch
~Bathroom
~Provide recommendations to:
~Buy a non-slip mat
~Install a grab rail
~Buy a commode chair for showering
~Stairways
~Provide recommendations to:
~• Fix an adhesive tape for stair contrast"
15779505|NCT04617821|Drug|Nab paclitaxel plus gemcitabine|Albumin-bound paclitaxel and gemcitabine are given intravenous infusion, repeated every 4 weeks for 1, 8, and 15 days, for a total of 4 to 6 cycle.
15780660|NCT04608305|Biological|IIBR-100 medium dose (prime)|Single administration of IIBR-100 1*10E6 pfu/ml
15779485|NCT04618029|Other|Education|"Techniques Description Energy Conservation
~Take your time
~Go to the toilet more often, so you don't have to rush
~Use a nearby toilet: commode, different bathroom
~Prepare ahead (e.g., toilet paper near, other items for toileting, etc.)
~Adjust equipment before changing position
~Avoid transfers when tired
~Ask for help if you feel sick or especially tired
~Allow time for eyes to adjust to change in lighting
~Task Simplification
~Plan and organise workspaces to eliminate unnecessary steps, save time, energy and reduce fatigue.
~Prioritise and plan activities, alternating between active and quiet jobs and include rest periods.
~Ergonomics
~Proper positioning while doing tasks
~Safe mobility around the home"
15779486|NCT04618016|Device|UHMWPE with Vitamin E|e.motion Pro (PS and UC) with MXE gliding surface
15779487|NCT04618016|Device|UHMWPE without Vitamin E|e.motion Pro (PS and UC) with β-PE and MXE gliding surface
15779488|NCT04618003|Behavioral|Adaptation of autonomic nervous system to activity in virtual reality|heart rate variability assessed at rest and during a physical activity in virtual reality.
15779489|NCT04617977|Behavioral|I-BMS for families with children suffering from eczema|It is a strength-based, family system approach to aid empowerment of individuals. It focuses on the interplay between physical and emotional well-being, the spiritual transformation of adverse life experiences, and the acceptance of adversity through reflection on the philosophical concepts of forgiveness and letting go. It integrates Western therapeutic techniques and Eastern philosophies to develop spiritual transformation through suffering and pain under a meaning-oriented framework. It consists of six three-hour consecutive weekly sessions: (1) awareness of body-mind connection; (2) regulation of emotion; (3) acknowledgement of the gains and losses in the caregiving or illness experience; (4) appreciation of self and others; (5) cultivation of acceptance; and (6) meaning reconstruction of caregiving or illness experience.
15779490|NCT04617977|Behavioral|Health education for parents whose children have eczema|It focuses on practical eczema management. It serves as a control for group effect between conditions. It consists of six three-hour sessions: (1) information about the physiology of eczema and its health impact; (2) recognition and avoidance of trigger factors and daily skin care; (3) dealing with itching and scratching; (4) stage-related treatment of symptoms and unconventional therapies; (5) general child nutrition, food allergies in eczema, and different forms of diets; and (6) self-management plan and problems in integrating into daily routine.
15779491|NCT04617964|Other|Ultrasound|Assessment the intra and interoperator reproducibility of the measurement of the right portal vein diameter at the routine third trimester ultrasound
15779492|NCT04617951|Dietary Supplement|Ishige Okamurae extracts group|Ishige Okamurae extracts 300 mg/day for 12 weeks
15779493|NCT04617951|Dietary Supplement|Placebo group|Placebo 300 mg/day for 12 weeks
15779494|NCT04617938|Behavioral|TACUNA plus Wellness Gathering|TACUNA provides three virtual workshops (two hours each) that use motivational interviewing and a virtual wellness gathering (WG). The workshops combine a one hour discussion of opioid, alcohol and marijuana use and social networks with one hour focused on three different traditional practices. TACUNA was adapted from our three-session workshop, MICUNAY (Motivational Interviewing and Culture for Urban Native American Youth) protocol, which was developed and tested for urban AI/AN adolescents and from focus groups conducted in Year 1. For the Wellness Gathering, youth will have members of their social network virtually attend these once-a-month gatherings. The WG will bring people together to celebrate health and wellness and tradition. The WG will focus on the importance of social networks in making healthy choices, and provide discussion on the role that AOD use and engagement in traditional practices among members of their social networks affect their choices.
15779495|NCT04617938|Behavioral|Opioid Education Workshop|The virtual opioid education workshop draws from prevention and education materials supplied and recommended by the National AI/AN Technology and Transfer Center, which is funded by SAMHSA. Materials are culturally relevant educational packages addressing opioid use through recorded webinars, toolkits, and other resources.
15779496|NCT04617925|Drug|Belantamab mafodotin|Belantamab mafodotin will be administered as a monotherapy intravenously at a 2.5 mg/kg calculated dose
15779497|NCT04617912|Device|Long AFOV PennPET Explorer|A long-axial field-of-view (LAFOV) time-of-flight PET scanner, developed at the University of Pennsylvania, being tested for real-world applications.
15779498|NCT04617899|Diagnostic Test|Intravascular imaging|Use of imaging catheter
15779499|NCT04617886|Other|Sadness induction|"Sadness state will be induced with a Virtual Reality program. Mood induction will be done with an emotional induction procedure in virtual reality (Mood induction parks (Baños et al., 2006)). This technique has proven to be effective in previous studies (e.g., van Strien et al. 2013). Virtual reality software simulates an urban park and includes several methods of sadness induction: Velten's tasks (1968) (sentence formulations with negative content about the self; for example, I am not valuable, I see no future); visualization of a image bank with emotional content from the international system of emotional images (IAPS, Lang et al.,1999); listening to a piece of music and viewing a film scene that demonstrated his effectiveness in inducing positive affect (Donen et al. 1952; Eich and Metcalfe 1989; Gross and Levenson 1995), and an autobiographical memory test."
15779500|NCT04617886|Other|Happiness induction|"Happiness state will be induced with a Virtual Reality program. Mood induction will be done with an emotional induction procedure in virtual reality (Mood induction parks (Baños et al., 2006)). This technique has proven to be effective in previous studies (e.g., van Strien et al. 2013). Virtual reality software simulates an urban park and includes several methods of sadness induction: Velten's tasks (1968) (sentence formulations with negative content about the self; for example, I am not valuable, I see no future); visualization of a image bank with emotional content from the international system of emotional images (IAPS, Lang et al.,1999); listening to a piece of music and viewing a film scene that demonstrated his effectiveness in inducing positive affect (Donen et al. 1952; Eich and Metcalfe 1989; Gross and Levenson 1995), and an autobiographical memory test."
15779501|NCT04617873|Procedure|Bilateral STN-DBS and T10-T12 SCS|simultaneous stimulation of bilaterally-STN-DBS combined with spinal cord stimulation
15779502|NCT04617860|Drug|WVE-120102|WVE-120102 is a stereopure antisense oligonucleotide. It is administered monthly via intrathecal injection.
15779503|NCT04617847|Drug|WVE-120101|WVE-120101 is a stereopure antisense oligonucleotide (ASO). It is administered monthly via intrathecal injection.
15779504|NCT04617834|Other|Quality Surveillance Data Collection|Data will be retrospectively collected through EHR queries
15779535|NCT04617600|Drug|MTA|Survival rate using MTA in cariously exposed vital primary molars
15779506|NCT04617821|Drug|mFOLFIRINOX|Intravenous oxaliplatin for 2 hours, day 1;Intravenous infusion of calcium formyl tetrahydrofolate (LV) for 2 h, day 1;Irinotecan intravenous infusion is added 30 minutes later for 90 minutes, day 1;Intravenous infusion of 5-fluorouracil (5-FU) continued for 46 hours.Repeat every 2 weeks for a total of 4-6 cycles.
15779507|NCT04617808|Other|Questionnaire|"The regulatory scheme applied to all investigative centers is as follows:
~Call from Center 15 by a major patient for secondary headache no traumatic. (i.e. not having been the victim of a head trauma during the 48 hours preceding the call)
~Detection of the pattern of non-traumatic headache, by the regulatory assistant medical with registration of the word cephareg in the medical regulation software in order to alert the regulator about the possible inclusion of the patient
~If possible, patient information on the collection of their data for research and possibility of opposing
~Filling of a medical questionnaire by the regulating doctor
~Weekly collection of medical questionnaires by investigating doctors"
15779508|NCT04617795|Device|Omnipod 5 Automated Insulin Delivery System|"The Omnipod 5 is a single hormone insulin delivery system intended for the management of diabetes in persons requiring insulin. Continuous subcutaneous insulin infusion may be delivered by user-defined settings (manual mode) or automatically adjusted in response to feedback from a continuous glucose monitor (CGM).
~The Omnipod 5 can automatically increase insulin delivery based on sensor glucose values from the continuous glucose monitor (CGM) and can decrease or suspend delivery of insulin when the glucose value falls below or is predicted to fall below predefined threshold values.
~The Omnipod 5 is designed to assist patients with diabetes in achieving glycemic targets set by their health care providers."
15779509|NCT04617782|Combination Product|Donepezil TDS|Transdermal Delivery System
15779510|NCT04617782|Drug|Aricept|Oral
15779511|NCT04617769|Behavioral|Psychoeducation|psychoeducational materials on trauma and safety behaviors
15779512|NCT04617769|Behavioral|Exposure|six 3-minute video exposure trials with an inter-trial interval of 2 minutes
15779514|NCT04617730|Device|Mepitel® film|This study is a comparative study between the standard procedure, which is to prescribe a hydro-active colloidal gel called Flamigel® to be applied to the irradiated area, and the use of Mepitel® Film.
15779515|NCT04617730|Other|Flamigel®|The control arm will be treated according to the standard of care.
15779516|NCT04617717|Procedure|Invasive cardiac electrophysiological study and ablation therapy|Invasive cardiac electrophysiological study with cathecholamine provocation and pacing procedures, as well as standard 3D mapping and PVC ablation
15779517|NCT04617717|Diagnostic Test|Cardiopulmonary exercise testing|Standard ergometer bicycle test
15779518|NCT04617717|Diagnostic Test|Cardiac MRI|Cardiac MRI with cine-imaging and late-gadolinium enhancement
15779519|NCT04617717|Diagnostic Test|Holter monitoring|24h 5 lead or 12 lead ECG recording
15779520|NCT04617717|Diagnostic Test|Transthoracic echocardiography|2D echocardiography
15779521|NCT04617717|Diagnostic Test|Coronary angiography|Conventional invasive coronary angiography or CT angiography as indicated
15779522|NCT04617704|Biological|GC012F injection|GC012F injection is a autologous dual CAR-T targeted BCMA and CD19. A single infusion of CAR-T cells will be administered intravenously.
15779523|NCT04617691|Drug|Guselkumab|Guselkumab will be administered as IV solution derived from FVP or PFS-U.
15779524|NCT04617678|Other|Prehabilitation Program|We will assess whether prehabilitation intervention helps mitigate adverse symptoms (e.g., anxiety, depression, suicidality, distress, nutritional status, dysphagia, sarcopenia, and well-being) on a sample of head and neck cancer patients. Subjects will attend a Prepare for Surgery Heal Faster session and meet with a physical therapist, registered dietician, speech language pathologist, and masters of social work at pre-treatment, 6-8 weeks post-treatment, and 5-6 months post-treatment completion.
15779525|NCT04617665|Other|One-handed mask ventilation|Using one-handed mask ventilation techniques during induction of general anesthesia
15779526|NCT04617665|Other|Two-handed mask ventilation|Using two-handed mask ventilation techniques during induction of general anesthesia
15779527|NCT04617652|Drug|Magnesium sulfate|Patients will receive 1 gm of magnesium in 10 ml over 5 minutes then infusion of 1 gm in 50 ml over one hour.
15779528|NCT04617652|Drug|Normal saline|Patients will receive 10 ml of saline, then infusion of 50 ml of normal saline over one hour.
15779529|NCT04617639|Behavioral|Physical exercise|Supervised home-based and community-based physical exercise with a dose required to increase cardiorespiratory fitness, i.e. intensity, duration and frequency that accumulates to at least 115 minutes a week of exercise, divided into at least 20 minutes a week of high/vigorous intensity physical activity (active minutes at about 85% of peak heart rate or Rated Perceived Exertion [RPE] of about 16 on Borg scale) and 95 minutes a week at moderate-intensity physical activity (active minutes at about 70% of peak heart rate or RPE of about 13 on Borg Scale), or continuous heart rate measurements amounting to at least 100 Personal Activity Intelligence (PAI) equivalents per week.
15779530|NCT04617639|Behavioral|Standard care|Standard care, i.e. advice at study start to follow international guidelines of moderate to vigorous physical activity intensity without further guidance and follow-up by study personnel.
15779531|NCT04617639|Behavioral|Observation group|Follow-up through mandatory national heath registries for primary endpoint, without any contact by study personnel
15779532|NCT04617626|Drug|Azithromycin|Single dose of azithromycin suspension
15779533|NCT04617613|Drug|Omeprazole, Amoxicillin, Metronidazole and Clarithromycin|The first group (standard triple therapy group) received omeprazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg. The second group (quadruple therapy group) received omeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg. Patients in both groups received omeprazole capsule twice daily before meals and the rest of the drugs twice daily after meals for 14 days.
15779534|NCT04617613|Drug|Omeprazole, Amoxicillin and Clarithromycin|The first group (standard triple therapy group) received omeprazole 20 mg, amoxicillin 1 g and clarithromycin 500 mg. The second group (quadruple therapy group) received omeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg, and metronidazole 500 mg. Patients in both groups received omeprazole capsule twice daily before meals and the rest of the drugs twice daily after meals for 14 days.
15779536|NCT04617600|Drug|TheraCal PT|Survival rate using TheraCal PT in cariously exposed vital primary molars
15779537|NCT04617587|Behavioral|Early Intervention|The early intervention (EI) is delivered during the NICU stay. It is a multisensory intervention which consists in three parts: parental training, massage therapy and visual interaction. The EI is first focused on parental training, according to PremieStart Protocol, in order to train parents to: recognize signs of infant stress and alert-available behavior through the identification of infant's behavioral states; adopt principles of graded stimulation; sustain infant's attention and respond to infant's cues; optimize interactions and avoid overwhelming infants through facilitation strategies. The program is held in eight main sessions and one additional post-discharge session. In addition, parents are trained and invited to daily promote preterm baby massage therapy and visual interaction (visual fixation/tracking and visual attention).
15779540|NCT04617561|Drug|Ursodeoxycholic acid|Participants received Ursodeoxycholic acid (13-15mg/kg/d po.)
15779541|NCT04617561|Drug|Ursodeoxycholic acid+Low Dose Glucocorticoid(Methylprednisolone)|Participants received Methylprednisolone (12mg/d po. in induction and 2-4mg/d in maintenance) combined with Ursodeoxycholic acid (13-15mg/kg/d po.)
15779542|NCT04617548|Combination Product|tDCS and CO-OP Group|Transcranial direct current stimulation modulates the excitability of targeted brain regions, and is thought to facilitate or inhibit neuroplasticity. Participants will receive anodal tDCS (1.5 mA) to the dorsolateral prefrontal cortex (dlPFC) for 20 minutes at the beginning of each session. CO-OP focuses on learning of a global problem-solving strategy, Goal-Plan-Do-Check (GPDC), within the performance of participant-chosen goals. Use of a broadly applicable strategy and meaningful activity ensures the intervention is salient to the participant and increases likelihood of transfer. Uniquely, therapists applying CO-OP use guided discovery methods to support participants in analyzing their own performance of a given task and generating potential solutions for improving performance. Participants become equipped with these skills through repetitive application of the Goal-Plan-Do-Check process.The intervention focuses on learning GPDC with gradual withdrawal of guided discovery methods.
15779543|NCT04617535|Drug|REGN10933+REGN10987 combination therapy|Administered intravenously (IV) single dose
15779544|NCT04617522|Drug|Sacituzumab Govitecan-hziy|Administered intravenously
15779545|NCT04617509|Drug|Formulation A GS-248|Formulation A of GS-248 in a capsule, dose 120 mg given as a single-dose of 3 capsules a´40 mg.
15779546|NCT04617509|Drug|Formulation B GS-248|Formulation B of GS-248 in a capsule, dose 120 mg given as a single-dose of 3 capsules a´40 mg.
15779547|NCT04617496|Behavioral|Combined speech and exercise intervention|Home-based exercise intervention with interactive automated speech response features
15779548|NCT04617496|Behavioral|Health education|Provision of general information about a variety of topics
15779549|NCT04617483|Biological|Two doses of commercial scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14|The antigen content of the commercial scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group 26-45.
15779550|NCT04617483|Biological|Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14|The antigen content of the pilot scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group 18-59.
15779551|NCT04617483|Biological|Two doses of pilot scale inactivated SARS-CoV-2 vaccine at the schedule of day 0,14 in elderly|The antigen content of the pilot scale inactivated SARS-CoV-2 vaccine was 600SU/0.5ml, vaccinated in the age group above 60.
15779552|NCT04617457|Drug|nal-irinotecan (nal-iri) (Onyvide), oxaliplatin (ox), 5-fluouracil (5-FU), folinic acid (FA)|preoperative chemotherapy
15779553|NCT04617444|Other|ENDS (vaporizer/e-cig) and smoking cessation counseling|Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit.
15779554|NCT04617444|Other|Smoking cessation counseling|Participants in the control group will receive smoking cessation counseling only. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit.
15779555|NCT04617431|Behavioral|Mobile health application and social media|"The intervention involved reminding the intervention group to upload their dietary diary every day. The researchers were trained by a dietitian and provided suggestions about diet and exercise to the intervention group. LINE  is a mobile app operated by LINE Corporation. All users can use texts, images, video, and audio for contact at any time. A LINE group was created to deliver medical knowledge of diet and exercise. Each of the messages were guided by a diet manual for kidney disease (edited by Department of Dietetics, National Taiwan University Hospital Yunlin Branch). The intervention group also asked questions about CKD management, and a teleconsultation of health information was provided. A daily target of 7,500 steps was set and used to emphasize the correct concepts about exercise. Participants were inspired in the intervention group if someone achieved the target number of steps."
15779556|NCT04617418|Behavioral|Change in touchscreen interactions|The investigators will measure the changes in touchscreen interactions using the TapCounter app by QuantActions
15779557|NCT04617405|Other|No interventions|No interventions
15779558|NCT04617392|Procedure|Laparoscopic sleeve gastrectomy|Sleeve gastrectomy involves removing a part of the stomach, limiting the amount of food the patient can eat.
15779559|NCT04617392|Other|Strength endurance training|Patients included in the active cohort arm with physical activity will undergo three months of strength endurance training under the supervision of a professional physiotherapist
15779560|NCT04617379|Behavioral|Stretching|One-year stretching program for 15 minutes every day
15779561|NCT04617366|Other|Individualized rTMS strategy|It will adjust the rTMS parameters based on the results of fNIRS.
15779562|NCT04617366|Other|Traditional rTMS strategy|The patients will always be given low-frequency rTMS to contralesional M1.
15779563|NCT04617353|Procedure|NO-based treatment of sterno-mediastinitis|"Preparation of a postoperative wound in case of infectious complications. A mandatory sampling material for culture and antibiotic sensitivity is collected before and after the air plasma flow treatment.
~Direct effect of the air-plasma flow on the entire wound surface in sterilization mode with an exposure of 2-3 minutes for each surgical wound, until the level of bacterial contamination decreases to 10-5 and below.
~The technique of using air-plasma flow when closing a wound after preventing infectious complications in it.
~In the postoperative period, daily air-plasma flow treatment in sterilization mode along the suture line for 3 minutes. Penetrating drainage NO supply in the biological stimulation mode daily for 10 days, with an exposure of 1-2 minutes up to 10 days, with a volume of up to 2 liters per minute.
~Collecting wound culture from the drainage containers on 1-3-7-12 days to detect pathogens and the bacterial number."
15779564|NCT04617353|Procedure|Treatment of sterno-mediastinitis|patients who were treated for sterno-mediastinitis according to clinical guidelines, the main method of which is a permanent irrigation and aspiration flow drainage method, as well as a Vacuum Assisted Closure (VAC) system of dressings for vacuum drainage
15779565|NCT04617340|Other|Multifaceted clinical pharmacy intervention|"Assessing patient and caregiver preferences
~Medication reconciliation on admission
~Performing a comprehensive medication review before discharge
~Promoting safe transition
~4.a. Compiling a patient friendly medication list
~4.b.Optimizing communication with healthcare providers in primary care:
~4.b.i.Providing a copy of the medication list for the community pharmacist
~4.b.ii. Contacting the general practitioner by phone
~4.b.iii. Contacting, if applicable the home care nurse or the nurse from the nursing home by phone.
~5.A motivation interview will take place before discharge with patients and caregivers
~6.Post-discharge follow-up: 6.a.Follow-up call to discuss potential drug therapy issues, therapy adherence and to resolve any pending issues 6.b.A telepharmacology service will be provided to primary healthcare professionals as a means to consult the ward-based clinical pharmacists and/or research team after discharge."
15779566|NCT04617327|Radiation|Hypofractionation|"Shorter radiation therapy means that a higher dose will be given on a daily basis. The goal is to target microscopic disease and decrease the chances of local recurrence.
~Organs at risk (OAR) will receive doses following the constraints from the Timmerman tables used for reference when using 5 or more fractions of EBRT.
~Treatment will be delivered every 2nd day, for a maximum of 3 fractions per week. Daily pretreatment Image Guided Radiotherapy Images (IGRT) (Cone-Beam CT - CBCT) will be co-registered with the CT simulation dataset to adjust patient position before each treatment by matching the bone adjacent to the planned tumour volume (PTV). Treatment will be administered if there is <3 mm in any dimension, or rotation is <3 degrees. If the isocentre set-up exceeds 3 mm at any given treatment session, the treatment couch will be translated to restore its planned position."
15779567|NCT04617314|Drug|RC108|RC108 for injection is a novel antibody-drug conjugate, with a c-Met-targeting antibody and a microtube inhibitor.
15779568|NCT04617288|Other|Ultrasound Therapy, SNAGs|
15779569|NCT04617275|Drug|PF-06882961|PF-68882961 will be provided as tablets twice a day (BID)
15779570|NCT04617275|Other|Placebo|Placebo comparator will be provided as tablets twice daily for 12 weeks
15779571|NCT04617262|Behavioral|Remote Problem Management Plus|Five sessions of low-intensity, trans-diagnostic psychological intervention including the teaching and practice of the following strategies: stress management, problem solving, behavioral activation, and strengthening social support
15779572|NCT04617249|Procedure|median anesthesia|giving median anesthesia
15779573|NCT04617249|Procedure|paramedian anesthesia|giving paramedian anesthesia
15779574|NCT04617236|Behavioral|Cultivando La Salud|"A lay health worker delivered educational intervention for breast and cervical cancer screening.
~In total, the Intervention Group subject participation will take approx. up to four hours (1 hour for interview, 1 hour for the second interview, and 1-2 hours for the CLS intervention) and Control Group up to four hours (One hour for interview, one hour for the second interview, up to two hours for educational intervention after the second interview).
~Follow-up data was collected 4-6 months post education session (intervention group) or post-baseline survey (control group)."
15779575|NCT04617223|Procedure|Endoscopic sinus evacuation|Evacuation of the sinus by using endoscope
15779576|NCT04617210|Other|Neurocognitive tests and blood taking|Battery of neurocognitive tests and questionnaires: MoCA, PHQ-9, Falls History, FIFE, STOPBANG, Nutritional Survey, CANTAB, Insomnia Severity Index, Bristol Activities of Daily Living Scale, NuDESC, 3D-CAM. Blood taking.
15779577|NCT04617197|Device|Transcutaneous electrical nerve stimulation with frequency-specific microcurrent resonant therapy|Transcutaneous electrical nerve stimulation with frequency-specific microcurrent resonant therapy using (Dragon Waves Resonant Home Care Electronic Nerve Stimulator (DW-1330), Taiwan Resonance Wave Research Co., Taiwan R.O.C,)
15779578|NCT04617184|Other|NO INTERVENTION|THERE IS NO INTERVENTION TO THIS TRIAL. THIS IS A REGISTRY
15779579|NCT04617171|Drug|Benralizumab 30 MG/ML [Fasenra]|Benralizumab/placebo initiated at an acute severe asthma exacerbation, then continued over a period of 48 weeks
15779580|NCT04617171|Drug|Placebos|Benralizumab/placebo initiated at an acute severe asthma exacerbation, then continued over a period of 48 weeks
15779581|NCT04617158|Procedure|Adjustable strabismus surgery|Adjustable surgery will be done using sliding nose technique using fornix approach
15779582|NCT04617145|Other|Aerobic exercise|resistive training which were conducted in the form of a series of exercises using free weights, and dumbles to increase the strength of arms, pectoral muscles, abdominal, back muscles and gluteal region. Patients carried out three sets of 20-30 dynamic repetitions or static isometric exercises for 40-60 seconds for each muscle group and rested 1-2 min between series. Sessions were conducted three sessions/week for eight weeks.
15779583|NCT04617132|Behavioral|MBCT/MBSR|This intervention teaches the practice of mindfulness - being aware of the present moment without judgement - to help reduce the emotional reactivity to thoughts and bodily sensations, which prevents downward spirals into depression, anxiety, or fear.
15779584|NCT04617119|Device|Threshold IMT device|10 breaths X 3 sets, two times a day for 2 weeks. starting intensity 10 % of pre-measured maximal inspiratory pressure.
15779585|NCT04617119|Other|Conventional physical therapy|daily
15779586|NCT04617106|Procedure|Radial artery cannulation|cannulation of Radial artery using standard IV cannula (axillary drug port will be taped using opaque adhesive)
15779587|NCT04617093|Device|PrismaLung+|Overall, 50 adult patients will be initiated on ECCO2R using PrismaLung+. A minimum of approximately 15 patients will be treated with ECCO2R using PrismaLung+ as stand-alone therapy and another minimum of approximately 15 patients (maximum of 20) will receive ECCO2R using PrismaLung+ in combination with CRRT.
15779588|NCT04617080|Procedure|SUPRACOR Regular|SUPRACOR algorithm with regular (100%) ablation profile. SUPRACOR is a presbyopic algorithm that consists of a pre-calculated pulse pattern combined to the refractive pattern to combine near, intermediate and distance vision correction.
15779589|NCT04617080|Procedure|SUPRACOR Strong|SUPRACOR algorithm with strong (130%) ablation profile. SUPRACOR is a presbyopic algorithm that consists of a pre-calculated pulse pattern combined to the refractive pattern to combine near, intermediate and distance vision correction.
15779590|NCT04617067|Drug|Paricalcitol|Paricalcitol 12mcg, administered orally on every day of each 28-day cycle.
15779591|NCT04617067|Drug|Gemcitabine (GEM) and Nab-paclitaxel|GEM (at 1,000 mg/m2) and Nab-paclitaxel (at 125 mg/m2 of bodysurface area), administered weekly for 3 of every 4 weeks (on days 1, 8 and 15 only).
15779592|NCT04617054|Drug|AB-106|600mg QD for each subjects.
15779593|NCT04617028|Drug|Jaktinib|Jaktinib Hydrochloride Tablets administered orally twice daily
15779594|NCT04617028|Drug|Placebo to match Hydroxycarbamide|Placebo to match Hydroxycarbamide Tablets administered orally twice daily
15779595|NCT04617028|Drug|Hydroxycarbamide Tablets|Hydroxycarbamide Tablets administered orally twice daily
15779596|NCT04617028|Drug|Placebo to match Jaktinib|Placebo to match Jaktinib Tablets administered orally twice daily
15779597|NCT04617015|Drug|Ipratropium Bromide|All subjects receive inhaled ipratropium once with measurement of spirometry before and after. Bronchodilator response of subjects with depression is compare to that of subjects without depression.
15779598|NCT04617002|Drug|ONC201|ONC201 is an oral, small molecule selective antagonist of DRD2
15779599|NCT04616989|Behavioral|Psycho-education|Provide psycho-education to members of the community
15779600|NCT04616989|Behavioral|Comparator|Distribution of COVID-19 leaflets to members of the community
15779601|NCT04616976|Biological|convalescent plasma|convalescent plasma was get from the patients who recovery from COVID-19
15779602|NCT04616963|Drug|Emtricitabine / Tenofovir Disoproxil Oral Tablet 200/300 mg|Following Phase I lead-in, all participants will continue PrEP with fixed dose combination daily oral F/TAF substituting for F/TDF in Phase II. Participants will continue to receive PrEP in accordance with standardized comprehensive methods of prescribing, which includes risk reduction counseling, adherence counseling, and clinical assessments with safety monitoring, as well as HIV and STI screening. Participants will receive daily adherence-supporting text message reminders through 12 weeks after F/TAF initiation.
15779603|NCT04616963|Drug|Emtricitabine Tenofovir Alafenamide 200/25 mg|Following Phase I lead-in, all participants will continue PrEP with fixed dose combination daily oral F/TAF substituting for F/TDF in Phase II. Participants will continue to receive PrEP in accordance with standardized comprehensive methods of prescribing, which includes risk reduction counseling, adherence counseling, and clinical assessments with safety monitoring, as well as HIV and STI screening. Participants will receive daily adherence-supporting text message reminders through 12 weeks after F/TAF initiation
15779604|NCT04616937|Dietary Supplement|GOS|Prebiotic
15779605|NCT04616937|Dietary Supplement|Placebo|Placebo
15779608|NCT04616911|Procedure|Rerouting seton|Excision of superficial fistula tract and placment of seton with rerouting of the fistula tract around the internal anal sphincter
15779609|NCT04616911|Procedure|LIFT|Ligation of the intersphincteric fistula tract
15779610|NCT04616898|Device|Venus Bliss|The Venus Bliss™ system is an aesthetic medical device designed to non-invasively reduce subcutaneous adipose tissue of the abdominal area and flanks. It is intended for use in individuals with a Body Mass Index (BMI) of 30 or less. The device consists of an external treatment component and an internal control component. The treatment console is a 1060nm diode laser applicator and a radio frequency applicator. In addition, a Bliss Belt is provided with the system to properly secure one or more applicators to the patient's body during treatment. Finally, the touchscreen monitor is used by the clinician to control the setting display on the main console. It also keeps the clinician informed of the device's status and operating parameters.
15779611|NCT04616872|Drug|Methotrexate-LDE|MTX-LDE 40mg/m2 (250mL total volume) IV and Folic acid 5mg by mouth (the day after MTX-LDE) weekly for 12 weeks
15779612|NCT04616872|Drug|Placebo-LDE|Placebo-LDE (250mL total volume) IV and Folic acid 5mg by mouth (the day after Placebo-LDE) weekly for 12 weeks
15779613|NCT04616859|Dietary Supplement|Alcohol and Energy Drink (AmED)|Multiple oral dose of alcohol mixed with ED
15779614|NCT04616859|Dietary Supplement|Alcohol and Energy drink Placebo|Multiple oral dose of alcohol mixed with ED placebo (soft drink)
15779615|NCT04616859|Dietary Supplement|Alcohol placebo and Energy drink|Multiple oral dose of alcohol placebo (water) mixed with ED
15779616|NCT04616859|Dietary Supplement|Alcohol placebo and energy drink placebo|Multiple oral dose of alcohol placebo (water) mixed with ED placebo (soft drink)
15779617|NCT04616846|Diagnostic Test|Peripheral venous ultrasound|Screening for VTE from D7 to 42
15779618|NCT04616807|Drug|Mexiletine|Observational Study
15779619|NCT04616794|Behavioral|Cognitive Engagement Group|Participants in this group will be encouraged to lead a cognitively stimulating lifestyle, as a means for cognitive decline/dementia risk reduction. This will be achieved by providing educational materials, practical tips and strategies, and suggestions about the different options to increase cognitively stimulating activities and by assisting participants outlining goals to progressively adopt a more cognitively active lifestyle.
15779620|NCT04616794|Behavioral|Physical Activity Group|Participants in this group will be encouraged to lead a physically active lifestyle, as a means for cognitive decline/dementia risk reduction. This will be achieved by providing educational materials, practical tips and strategies, and suggestions about the different options to increase physical activities and by assisting participants outlining goals to progressively adopt a more physically active lifestyle.
15779686|NCT04616313|Diagnostic Test|Blood analysis|Participants will have their blood drawn and analysed for eosinophil count.
15779688|NCT04616287|Other|Neuropsychological assessment and Multimodal brain MRI|Neuropsychological assessment and Multimodal brain MRI
15779621|NCT04616794|Behavioral|Diet Group|Participants in this group will be encouraged to adopt a healthy diet, as a means for cognitive decline/dementia risk reduction. This will be achieved by providing educational materials, practical tips and strategies, and suggestions about the different options to change their diet and by assisting participants outlining goals to progressively adopt a Mediterranean-like diet.
15779622|NCT04616794|Behavioral|Multimodal group|Participants assigned to this group will select which domain they wish to tackle first. Interventions are as described for the single-domain interventions.
15779623|NCT04616781|Dietary Supplement|"Ketone Ester (R)-3-hydroxybutyl (R)-3-hydroxybutyrate"|nutritional ketone ester
15779624|NCT04616781|Drug|Isocaloric dextrose placebo|Drink indistinguishable from ketone ester
15779625|NCT04616781|Other|Alcohol drinks|drink an alcohol priming dose to produce a 0.03 g/dl breath alcohol concentration (BrAC) followed by a choice paradigm in which subjects receive 2 trays of 4 min-drinks each beverages Each min-drink would achieve 0.015 g/ld BrAC over a 1 hour period to achieve a max 0.1 g/dl BrAC.
15779626|NCT04616768|Other|PRO questionnaire|These text message surveys will inquire about seven symptoms, requesting a response rating the patient's response. The seven symptoms have been selected by lung and GI oncology clinicians at PCAM from a list of twelve validated symptoms from the National Cancer Institute's Common Terminology Criteria for Adverse Events and will be scored on a five point scale from 0 (no present) to 4 (disabling). The patients will also receive a question asking about their activity level over the prior month
15779627|NCT04616768|Other|Step monitoring|A CRC will provide patients with a Fitbit at enrollment and instruct them on how to wear the Fitbit device and periodically sync the device with their phone which will send updated step data to the research team.
15779628|NCT04616768|Other|Active nudge text feedback|"Intervention patients in arm c will receive text feedback describing worsening or severe symptoms collected from their remote PRO questionnaires (i.e. Your following symptoms are severe or have gotten worse:) and their step count (Your Fitbit step count compared to last week is worse.). They will also receive an active nudge question on their upcoming visit (i.e. Do you plan on discussing these symptoms with your oncologist at your upcoming visit? Type 1 if you plan to discuss them; Type 2 if you do not plan to discuss them.)."
15779629|NCT04616768|Other|PROStep Dashboard (clinicians)|"The study team will provide an updated PROStep Dashboard to lung or GI oncology clinicians for each patient enrolled in the intervention arms prior to their appointments. W2H will generate the dashboards and the study team will physically deliver it to their office or touchdown space or send electronically. The Dashboard will include:
~Home-based PRO report, including the weekly survey results for each question in tabular and graphical form
~Step data report, including a summary of number of daily steps in graphical form (with rolling weekly averages) and weekly averages in tabular form
~A list of all acute care utilization in the UPHS system in the prior 6 months including Oncology Evaluation Unit visits, Emergency department visits, Inpatient admissions
~Whether the patient has had an outpatient palliative care visit
~Whether the patient has had a documented Serious Illness Conversation"
15779630|NCT04616755|Other|Measuring changes of Little´s irregularity index ( sum of 5 contact point discrepancies together) measured in mm 2 years after retention have been I place.|Measuring changes occurred under 2 years which the retention devices have been in place between the groups
15779631|NCT04616742|Drug|[14C]SHR6390|Patients will receive single dose of orally [14C]SHR6390 on Day 1.
15779632|NCT04616729|Drug|Triptorelin 3.75 MG Injection|Depot Group (Group A) will receive Triptorelin 3.75mg Depot form for final oocyte maturation.
15779633|NCT04616729|Procedure|Transvaginal oocyte retrieval|Patients in both groups will undergo a transvaginal oocyte retrieval after ovarian stimulation.
15779634|NCT04616729|Drug|Triptorelin Injection|Daily Group (Group B) will receive Triptorelin 0.2mg Daily form for final oocyte maturation.
15779635|NCT04616716|Drug|FMTN|Single dose of FMTN after high-fat meal,low-fat meal and fast
15779636|NCT04616703|Radiation|CT imaging|CT of abdomen
15779638|NCT04616651|Behavioral|Online Survey|Participants respond to online survey questions either before or after using the Chatbot O2O intervention.
15779639|NCT04616651|Behavioral|Chatbot prototype|An online, automated, menu-based agent in which all responses are pre-programmed to be consistent with the existing O2O program. The chat-like responses help guide the participant through a process with the goal of developing a list of questions for their upcoming appointment with a cancer clinician. The session is meant to be completed in one sitting and estimated to take about 45 minutes to complete (including the pre- or post-intervention survey); however, if a participant stops in the middle, they may go back and complete the Chatbot session (or survey).
15779640|NCT04616651|Behavioral|Open to Options (O2O) Program|Evidence-based program developed by Cancer Support Community that helps patients actively engage in their treatment decision process by preparing them for their upcoming appointments.
15779641|NCT04616638|Behavioral|Resistance Training for Empowerment (RT-POWER)|The EG intervention was designed using the Social Cognitive Theory and its four sources of self-efficacy to promote a participant's (a) involvement in exercise planning, (b) muscular strength, and (c) independent functional performance. It consisted of three phases, which were adapted from the Self-Determined Learning Model of Instruction (Wehmeyer et al., 2000). This model draws from theory and research on self-management and self-control (Bandura, 1986; Martin et al., 1988). Participants were taught by their coaches how to (a) set a goal to meet fitness needs (Phase 1), (b) make a plan to meet goals (Phase 2), and (c) adjust actions to complete the plan (Phase 3).
15779642|NCT04616638|Behavioral|A traditional RT intervention|The control intervention also consisted of a three-phase instructional process. Consistent with traditional RT interventions (ACSM, 2009), the coaches rather than the participants, were the primary agents for goal-setting, exercise planning, goal attainment monitoring, and readjusting of the exercise plan. Neither the visual activity schedules nor the system of least-to-most prompts was used in this intervention.
15779643|NCT04616612|Behavioral|SystemCHANGE (TM)|Participants randomized to the refined SystemCHANGE™ intervention will receive 7 personalized sessions with a nurse-interventionist (session 1 virtual face-to-face, sessions 2-7 via phone) and weekly feedback MMS message reports delivered to mobile phones.
15779687|NCT04616313|Other|Questionnaires|Participants will complete questionnaires to assess activity related dyspnea, respiratory symptoms and health status impairment and respiratory related quality of life.
15779644|NCT04616612|Other|Attention Control|Participants randomized to attention control will receive nurse-led kidney disease self-care education based on materials developed by The National Institute of Diabetes and Digestive and Kidney Diseases and The National Kidney Foundation. Similar to the intervention, participants will receive one virtual visit from the nurse-interventionist and 6 phone calls (weeks 2, 3, 4, 5, 6 and 7) and weekly educational MMS messages delivered by mobile phone.
15779645|NCT04616586|Drug|Siltuximab|11 mg/kg IV administered over 1 hour
15779646|NCT04616586|Other|Normal Saline|IV administered over 1 hour
15779647|NCT04616573|Device|OMNI® Surgical System|Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System
15779648|NCT04616573|Device|iStent inject|Trabecular meshwork implantation
15779650|NCT04616547|Other|Questionnaire Administration|Ancillary studies
15779651|NCT04616547|Radiation|Tin Sn 117m DTPA|Given IV
15779652|NCT04616534|Procedure|Biopsy|Undergo biopsy (dose expansion cohort only)
15779653|NCT04616534|Drug|Elimusertib|Given PO
15779654|NCT04616534|Drug|Gemcitabine|Given IV
15779655|NCT04616521|Procedure|Deep brain stimulation|The surgical intervention named deep brain stimulation is a well-established neurosurgical treatment for moderate-to-advanced stage PD. The targets used in this study are STN and GPi, which are widely accepted and used for symptom control in PD. The devices used for intervention have been approved by Chinese National Medical Products Administration (CFDA). The postoperative drug dosage adjustment depends on the efficacy of DBS and the judgment of the movement disorder specialist.
15779656|NCT04616508|Behavioral|motor control assessment|Basic science study of control of reaching movements
15779657|NCT04616495|Procedure|Liver transplantation|Chemotherapy and liver transplantation
15779658|NCT04616482|Behavioral|Digital therapeutic carbohydrate restriction (TCR) program|A 12-week, personalized, online program to teach and coach patients about therapeutic carbohydrate restriction as for obesity and/or T2D (or risk of T2D). The program is intended to enhance the usual clinical care provided for patients.
15779659|NCT04616469|Procedure|Root canal treatment using TruNaomy rotary files|Trunatomy rotary files will be used for the process of cleaning and shaping of the root canal system
15779660|NCT04616469|Procedure|Root canal treatment using race rotary instruments|Race rotary files will be used for the process of cleaning and shaping of the root canal system
15779663|NCT04616443|Biological|OH2 injection|Oncolytic Type 2 Herpes Simplex Virus
15779664|NCT04616443|Biological|HX008 injection|Recombinant humanized anti-PD-1 monoclonal antibody of injection
15779665|NCT04616430|Drug|Topical endoxifen|topical solution
15779666|NCT04616430|Drug|Placebo|topical
15779668|NCT04616404|Dietary Supplement|500 mg of artichoke extract|Tablets containing 500 mg of artichoke extract (triple standardized to contain caffeoylquinic acids ≥ 5.0%; flavonoids ≥ 1.5%; cynaropicrin ≥ 1.0%, by HPLC)
15779669|NCT04616404|Other|Placebo|Tablets with no active ingredient
15779670|NCT04616391|Device|insulin pump Medtronic 780G|"Patients from the AHCL group will use the MiniMed 780G AHCL system. This system is already CE-marked.
~The AHCL system will be initiated first in Manual Mode (i.e. without AHCL control) with suspend before low feature (Visit 1).
~The AHCL system will be initiated in Auto Mode (i.e. with AHCL control) at Visit 2 with the settings in the below table. The Insulin to Carb ratio (ICR) and the Active Insulin Time (AIT) may be adjusted by the physician during the study. The glucose target may not be adjusted, unless in case of safety concerns. The patients may not adjust system settings without consulting with the physician.
~At each visit, the AHCL system data will be downloaded and reviewed by the physician. The patient interaction with the system will be evaluated, included sensor calibration, bolus management (before the meals and for corrections as needed), alarms and Auto Mode exits."
15779671|NCT04616378|Other|Phase 2 Prescribed Prosthesis|Everyday used prosthesis that was prescribed by their physician.
15779672|NCT04616378|Other|Phase 2 Robotic Prosthetic Leg|The RPL consists of a passive-dynamic ankle, powered knee, and an on-board inertial measurement sensors with an on-board kinetic and kinematic data collection system for analysis.
15779673|NCT04616378|Other|Phase 3 No Prosthesis|No prosthetic device is attached.
15779674|NCT04616378|Other|Phase 3 Robotic Prosthetic Leg|The RPL consists of a passive-dynamic ankle, powered knee, and an on-board inertial measurement sensors with an on-board kinetic and kinematic data collection system for analysis.
15779675|NCT04616378|Other|Phase 3 Prescribed Prosthesis|Everyday used prosthesis that was prescribed by their physician.
15779676|NCT04616365|Procedure|Semi-Elective Lung Transplantation|When suitable donor lungs become available for a consented recipient, and the donor cross clamp time occurs between 6PM and 4AM, the transplant procedure (anesthesia starting time) will be allowed to be moved to a 6AM start or later with the lungs being preserved at 10°C cold static preservation upon arrival to our hospital using a specific incubator. The maximum allowed time between donor cross clamp and recipient anesthesia initiation will be 12 hours.
15779677|NCT04616352|Other|Resistance to cefuroxime|Non susceptibility in vitro testing
15779678|NCT04616339|Drug|PF-06882961 100 mg|PF-06882961 100 mg will be provided in 4 different oral formulations (Treatment A,B,C,D). Participants will receive each formulation in one of 4 periods
15779681|NCT04616313|Diagnostic Test|Hyperpolarized Xenon-129 MRI of the lungs|Participants will be imaged using MRI using hyperpolarized xenon-129 gas as a contrast gas
15779682|NCT04616313|Diagnostic Test|Computed Tomography (CT)|Participants will undergo a CT scan of the thoracic cavity
15779683|NCT04616313|Diagnostic Test|Pulmonary Function Tests (PFT)|Participants will have their lung function evaluated using PFT
15779684|NCT04616313|Diagnostic Test|Cardiopulmonary exercise testing (CPET)|Participants will perform cardiopulmonary exercise testing as a measure of exercise capacity
15779685|NCT04616313|Diagnostic Test|Sputum analysis|Participants will provide a sputum sample that will be analysed for eosinophils
15779690|NCT04616261|Behavioral|Training|6 weeks of training
15779691|NCT04616261|Drug|Formoterol|inhalation of 54 microg formoterol
15779692|NCT04616261|Drug|Placebo|inhalation of placebo
15779693|NCT04616248|Biological|Anti-CD40 Agonist Monoclonal Antibody CDX-1140|Given IT
15779694|NCT04616248|Drug|Poly ICLC|Given IT
15779695|NCT04616248|Radiation|Radiation Therapy|Undergo radiation therapy
15779696|NCT04616248|Biological|Recombinant Flt3 Ligand|Given IT
15779697|NCT04616235|Drug|Tocilizumab Injectable Product|The intervention group will undergo intense aerobic exercise with prior IL-6R infusion for 1h prior to the exercise bout.
15779698|NCT04616235|Other|Saline 0.9% 100 ml NaCl 0.9% will be infused over 1 hour|The control group will undergo intense aerobic exercise with saline infusion for 1h prior to the exercise bout
15779699|NCT04616222|Drug|CELSIOR® group|Patient who received Celsior® during their transposition of the great vessels surgery according to the routine care.
15779700|NCT04616222|Drug|Saint-Thomas group|Patient who received Saint-Thomas during their transposition of the great vessels surgery according to the routine care.
15779701|NCT04616209|Biological|donor-derived NK cell infusion|PB103 administrations will be separated by 4-week interval
15779704|NCT04616183|Drug|Abemaciclib|Given PO
15779705|NCT04616183|Biological|Cetuximab|Given IV
15779706|NCT04616183|Drug|ERK1/2 Inhibitor LY3214996|Given PO
15779707|NCT04616170|Other|Hip extension|Hips extended at the time of vaginal delivery
15779708|NCT04616170|Other|Usual Care|"Hips positioned in the usual care position per provider preference at the time of vaginal delivery"
15779709|NCT04616157|Behavioral|ICBT-I|Cognitive-behavioral therapy for insomnia
15779710|NCT04616144|Device|Fresh Corneal Lenticule Implantation using Relex-Smile VisuMax Femtosecond Laser|Fresh Corneal Lenticule Implantation using ReLex-Smile
15779711|NCT04616118|Other|Phone Visit|Participants randomized to this arm will receive usual care via telephone only
15779712|NCT04616118|Other|Video Visit|Participants randomized to this arm will receive usual care via video call
15779713|NCT04616105|Drug|REGN6490|Single dose of REGN6490
15779714|NCT04616105|Drug|Placebo|Placebo matching single dose of REGN6490
15779715|NCT04616092|Drug|FEFINJECT|FEFINJECT injection
15779716|NCT04616079|Drug|REGN6490|Single dose of REGN6490
15779717|NCT04616079|Drug|Placebo|Placebo matching single dose of REGN6490
15779720|NCT04616053|Behavioral|IMPACT intervention|A referent is assigned to the patient. A referent is a health worker (nurse, nutritionist, psychologist …). Patient builds with his referent a free care program (without condition or limit). The patient can choose individual consultation (for example : nutrition, tabacology, psychology …) and/or collective care (for example : patient education, physical activity, relaxation …). A community health worker can help patient with his health administrative procedures. This intervention lasts 6 months.
15779721|NCT04616040|Drug|Camrelizumab|The recommended formulation of Camrelizumab is 200 mg every time, or 3 mg/Kg according to body weight, intravenously infused.
15779722|NCT04616027|Drug|PF-06882961 20 mg|PF-06882961 20 mg single oral dose provided in tablet form administered in a fed state on Day 1
15779723|NCT04616014|Drug|ORMD-0801 QD|8 mg, QD
15779724|NCT04616014|Drug|ORMD-0801 BD|8 mg, BD
15779725|NCT04616001|Drug|IVIG|Patients will receive IVIG daily for four days.
15779726|NCT04615975|Dietary Supplement|Ketogenic diet with phytoextracts|Patients were provided with an individualized nutritional ketogenic plan during hospitalization
15779727|NCT04615962|Drug|Hydrocortisone Acetate 1% Cream|Hydrocortisone Acetate is the synthetic acetate ester form of hydrocortisone, a corticosteroid with anti-inflammatory and immunosuppressive properties.
15779728|NCT04615962|Drug|Mometasone Furoate|Mometasone is a medium-strength corticosteroid.
15779729|NCT04615962|Drug|SNG100|A combination of low potency steroid and skin barrier repair agent
15779732|NCT04615936|Other|Methylene-Blue Photodisinfection|Participants will receive a pre-treatment nasal swab followed MB-PDF, this involves an MB nasal spray, followed by five minutes of red-light exposure into each nostril. Ten minutes after the treatment, a post treatment nasal swab will be performed.
15779733|NCT04615923|Drug|Pridopidine|"Administration: Oral
~Dose: 45mg twice daily"
15779734|NCT04615923|Drug|Matching Placebo|"Administration: Oral
~Dose: one capsule twice daily"
15779735|NCT04615910|Radiation|68Ga-NODAGA-exendin-4 PET/CT|68Ga-NODAGA-exendin-4 PET/CT
15779736|NCT04615897|Procedure|new tecnology intervention|"The intervention consists of 16 sessions, performed with a frequency of twice a week, the final evaluation was made within three days after the end of the last treatment session. It is used for the motor task, the Fishing Under Zero exercise, included within the balance modality and the so-called Step Plus located in the aerobic exercise folder. Each subject carried out the training taking into account the following methodology: 3 cycles of the Fishing under zero exercise, one cycle of the Step Plus exercise and 3 cycles of the Fishing under zero exercise, the approximate duration of the task being about 30 minutes."
15779737|NCT04615884|Dietary Supplement|Chinese herbs formula: Shu Yu Wan|Shu Yu Wan Formula is a combination of 23 natural chinese herbs.This formula may be used to relieve chemotherapeutic side effects or cancer-related symptoms.
15779739|NCT04615871|Drug|semaglutide|semaglutide 0.25 mg s.c. on Day 0 after randomization, then semaglutide 0.5 mg s.c. on Day 7, Day 14 and Day 21
15779740|NCT04615858|Dietary Supplement|Genepro Generation 3 Protein|Generation 3 Genepro Protein. Micronized protein. Zero lactose. No gluten. All Natural. No flavor. No Sugar. FODMAP Certified protein. 11g in weight, scoop.
15779741|NCT04615858|Dietary Supplement|Whey Protein|Nutrition industries number 1 selling whey protein powder. No flavor. Gluten Free. 30g scoop.
15779743|NCT04615832|Device|Comparator full face mask 1|Full face mask for PAP therapy applied in a home environment
15779744|NCT04615832|Device|Comparator full face mask 2|Full face mask for PAP therapy applied in a home environment
15779745|NCT04615832|Device|Comparator full face mask 3|Full face mask for PAP therapy applied in a home environment
15779746|NCT04615832|Device|Toffee Full Face Mask|Full face mask for PAP therapy applied in a home environment
15779747|NCT04615819|Other|Kidney Transplant Fast Track (KTFT)|Streamlined KT evaluation involving completion of most or all testing on the same day a patient arrives for their first pre-transplant clinic appointment. Or, a transplant clinic scheduler secures testing within a 2 week period.
15779748|NCT04615819|Other|Peer Navigation (PN)|Uses trained, previous KT recipients who meet weekly to monthly with patient participants to provide tailored information and assistance in completing the necessary steps to proceed to transplant.
15779749|NCT04615806|Drug|Indocyanine green solution|ICG solution was endoscopically injected into the esophageal submucosa at the four quadrants around the tumor.
15779750|NCT04615793|Other|PILATES EXERCISES|The experimental group will receive Pilates exercises focusing on lower limb strength, flexibility and coordination in addition to exercises given to control group. Exercises or movements were done on a mat, on an exercise ball or in standing position while emphasizing on spinal and pelvic alignment, maintaining core contraction and the rhythm of respiration. All exercises were done for 10 repetitions with a rest period of two minutes before commencing the next exercise, and lasted for about 45 minutes. All the groups will receive the above mentioned interventions thrice in a week for a period of 10 week
15779751|NCT04615780|Other|mouthwash with green tea|All patients received instructions for using the Bass brushing method to brush their teeth with a soft small-headed toothbrush. The intervention group rinsed the mouth with 100 ml green tea solution for 60 seconds at least twice daily. For the preparation of the green tea mouthwash, green tea solution was made with 5 g (1 teaspoon) of green tea powder dissolved in 100 ml water to produce 5% green tea mouthwash, as described in a previous study (Eshghpour, et al., 2013). The green tea powder was ground from Camelia sinensis leaves and regularly provided by the researcher. The green tea solution is made for a single use and remade before rinsing each time. When patients return to the outpatient monthly, the researcher first confirms patients' compliance, then assists with solving difficulties and gives encouragement.
15779752|NCT04615780|Other|mouthwash with tap water group|All patients received instructions for using the Bass brushing method to brush their teeth with a soft small-headed toothbrush. The control group rinsed the mouth with 100 ml tap water for 60 seconds at least twice daily.
15779753|NCT04615767|Dietary Supplement|D-chiro-inositol|as described previously
15779754|NCT04615754|Dietary Supplement|Hyperketonemia - use of ketone (3-OHB) infusion|The effect of intravenous ketone supplement
15779755|NCT04615754|Dietary Supplement|Placebo - use of saline infusion|Saline is infused as an comparator
15779756|NCT04615741|Behavioral|Trauma Informed Yoga|One licensed yoga instructor, trained in trauma-informed yoga delivery, will lead the online sessions. Participants will be instructed to engage in the class from a mat or chair in their home or move between them as the class unfolds. The instructor will begin the class by introducing the week's theme (e.g. grounding and safety, non-attachment, imprints of the past and impacts on our reactions to COVID-19, connection to nature), followed by a breath practice (10 min), a yoga practice (50 min), a meditation practice (10 min), and closing words (10 min).
15779757|NCT04615741|Behavioral|Trauma Informed Psychotherapy|Two licensed counsellors (MSW-trained) will co-facilitate the online version of this program. Facilitators will begin the session by introducing the week's theme (e.g. setting goals while working from home, being mindful, health coping) (10 min), followed by a lecture and activity to integrate learning (e.g. large and small group discussion using Zoom break out rooms, journaling) (70 min), and closing words (10 min).
15779758|NCT04615728|Procedure|laparoscopic or open appendicectomy|Laparoscopic/open appendicectomy versus conservative management with antibiotic therapy with or without image-guided drainage of appendicular abscess/collection
15779759|NCT04615715|Behavioral|CMV Risk-Reduction Intervention|CMV Risk-Reduction Intervention
15779760|NCT04615715|Behavioral|Stress Reduction Messaging|Stress Reduction Messaging
15779761|NCT04615702|Diagnostic Test|serum lipase or amylase|"Laboratory ( elevated serum lipase or amylase at least 3 times above the normal limits) is helpful in diagnosis
~Acute pancreatitis is diagnosed when two of three criteria are present including:
~Clinically (abdominal pain consistent with acute pancreatitis),
~Laboratory ( elevated serum lipase or amylase at least 3 times above the normal limits)
~Imaging criteria of acute pancreatitis"
15779762|NCT04615702|Device|ultrasound|helpful in diagnosis of acute pancreatitis and its etiology (Gallstones)
15779763|NCT04615702|Device|CT|helpful in diagnosis of acute pancreatitis and its etiology . assist in detection of type and severity of acute pancreatitis
15779764|NCT04615702|Diagnostic Test|Liver enzymes (Bilirubin, alanine transferase (ALT), aspartate aminotransferase, (AST) and alkaline phosphatase). Calcium. Triglycerides.|help in diagnosis of the etiology of acute pancreatitis elevated Bilirubin, ALT, AST and alkaline phosphatase suggest biliary pancreatitis
15779765|NCT04615702|Device|EUS /Secretin-stimulated magnetic resonance cholangiopancreatography (MRCP)|helpful in idiopathic acute pancreatitis diagnosis
15779782|NCT04615637|Device|MEG recordings|"Classical MEG recordings (patient at rest, normal subjects stimulated with visual, motor, somesthesic and auditory stimuli).
~MEG recordings with our OPM He4 prototype (patient at rest, normal subjects stimulated with visual, motor, somesthesic and auditory stimuli)."
15779783|NCT04615624|Drug|Furosemide|Furosemide, a loop diuretic
15779784|NCT04615624|Other|Placebo|Normal saline
15779785|NCT04615611|Drug|salbutamol|inhalation of salbutamol
15779786|NCT04615611|Drug|Placebo|administration of placebo
15779766|NCT04615702|Drug|Ringer lactate|"The initial infusion rate for mild cases :
~For patients without dehydration is (130-150mL/h).
~In case of dehydration: (150-600mL/h) with close monitoring of patients with comorbidities such as cardiac problems or renal failure to avoid volume overload.
~The initial infusion rate for both severe cases :
~For patients without dehydration is (130-150mL/h).
~In case of dehydration/ shock: (150-600mL/h) with close monitoring of patients with comorbidities such as cardiac problems or renal failure to avoid volume overload d. The target
~A mean arterial pressure of 65mmHg or more,
~Urine output of 0.5mL/kg per hour or more When these parameters achieved, the infusion rate decreased to the level that maintain these parameters."
15779767|NCT04615702|Combination Product|NSAID / paracetamol +/- opiates+/- epidural analgesia|"Pain control (Modified World Health organization (WHO) analgesia ladder) Step1: NSAID / paracetamol Paracetamol 1gm IV infusion /8h + Diclofenac sodium 75mg /12h.
~Step 2: Opiates +/- NSAID/ paracetamol Pethidine 25 mg IV/4h
~Step 3: Interventional treatment (epidural analgesia) +/- opiates +/- NSAID/ paracetamol In case of severe pain not responding to the above analgesia"
15779768|NCT04615702|Combination Product|Quinolones + Metronidazole /Carbapenems ± Metronidazole|"Mild attack: no antibiotic prophylaxis administered.
~Severe attack:
~Timing: Antibiotic prophylaxis administered to cases presented early within 72 hrs of disease onset.
~Duration: Not more than 2 weeks
~Antibiotics given:
~Quinolones + Metronidazole ( the 1st choice in ward) Ciprofloxacin 400mg IV /12 h + metronidazole 500mg IV/8h
~Carbapenems ± Metronidazole (the 1st choice in ICU patients and in case of sensitivity to quinolones) Imipenem .5gm IV/6h + metronidazole 500mg IV/8h
~b. Therapeutic (in cases with pancreatic or extrapancreatic infections)
~In case of pancreatic infection, Carbapenems ± metronidazole were given."
15779769|NCT04615702|Dietary Supplement|Fresubin 2Kcal fiber drink|"Severe cases Timing: Within at least 48 hrs of admission provided that there are no intestinal complications.
~Route: Nasogastric tube Nutrients: Polymeric feeding formula
~Nutrient: Fresubin 2Kcal fiber drink 200ml (2Kcal/ml)
~Total caloric requirements ꞊ body weight (kg) X 30Kcal/day Pattern : Continuous infusion
~The nutrition started with small amount and increased gradually over 16hrs
~Infusion rate ꞊ Total caloric requirements / 16hrs"
15779770|NCT04615702|Device|nasogastric tube|in case of ileus or vomiting
15779771|NCT04615702|Procedure|retroperitoneal necrosectomy|"General anesthesia , Supine position with 30 degree tilt towards the right side
~A left subcostal 5 cm incision is performed one finger below the left costal margin over the midaxillary line and the muscles were divided sequentially
~Then, aspiration is done from the possible collection.
~After confirmation that it was the site of the collection, the fibrotic thick wall was opened by a scissor, as the collection is opened, pus drained spontaneously.
~At first, a wide suction was introduced in the cavity and the friable loose necrotic tissue was aspirated. Then, a circuit of flushing saline was created in the residual cavity by injection of saline through the previously placed PCD followed by aspiration of the saline and detached loose necrotic tissue fragments by the wide suction tube
~After completion of the procedure, large bore surgical drain was placed into the collection. The fascia was closed over the drains. The skin closed by interrupted sutures"
15779772|NCT04615702|Procedure|open necrosectomy|"Open necrosectomy was done after failure of the minimally invasive techniques. The procedure was done under general anesthesia under the coverage of Tienam (.5gm/6h IV) following the results of culture and sensitivity of the percutaneous drain effluent Surgical exploration of the peritoneal cavity was done through midline exploratory incision, there were 2 large pus collections extending from the Rt. and Lt. Lumber regions deep down into the pelvis, the intervening septa were divided and the pus was aspirated by a wide suction drain.
~The lesser sac was opened and necrosectomy was done The previously placed PCD repositioned in the site of necrosectomy as a port for continuous irrigation while a wide tube drain was placed in the lesser sac for drainage. Another 2 tube drains were placed in the pelvis."
15779773|NCT04615702|Procedure|Endoscopic transmural cystogastrostomy|"for pancreatic pseudocyst Antibiotic prophylaxis with Ciprofloxacin 400mg IV /12 hour was administered before the procedure and continued for 5 days after the procedure At first the cyst morphology was evaluated by EUS and color Doppler ultrasound is used to identify nearby vessels The puncture was performed using a 19-gauge needle, which was introduced into the pseudocyst via a therapeutic linear array echoendoscope. Then, a 0.035-inch guidewire was introduced through the needle and coiled within the pseudocyst under fluoroscopic guidance.
~The needle was removed and a 10F cystotome was advanced over the guidewire and the tract was dilated by the cystotome, after dilatation, a 10F double-pigtail stent was placed and a sample of the aspirate is sent for chemical and microbiological analysis"
15779774|NCT04615702|Procedure|open cystogastrostomy|"for pancreatic pseudocyst general anesthesia, 1 gm of cefotax was given IV at the induction of anaesthesia, supine position over the operating table A transverse supraumbilical incision was performed. A 5 cm horizontal anterior gastrotomy was performed (Image 23a). Hemostasis of the submucosal vessels was performed before the incision of the gastric mucosa.
~First, the cyst was punctured followed by an incision of 5 cm at the posterior gastric wall. Aspiration of the cyst content was done for chemical and microbiological analysis The wall of the pseudocyst is hemmed to the gastric wall with continuous sutures made of a vicryl 2/0 alongside the entire circumference of the orifice Nasogastric tube was placed in the stomach. The procedure was completed by suturing the anterior gastrotomy with a vicryl 2/0 continous sutures in 2 layers A tube drain was inserted at the pelvis with closure of the abdominal wound in a standard way."
15779775|NCT04615702|Procedure|percutaneous catheter drainage (PCD) for infected necrosis|"PCD
~The percutaneous drainage catheter placed through peritoneal approach under US guidance, the drain size was 12 F.
~After placement of the percutaneous catheter, aspirate was sent for microbiological assessment
~The PCD was flushed with 50 ml saline, three times daily to keep the drain open and improve lavage of the collection"
15779776|NCT04615702|Procedure|Endoscopic ultrasound (EUS) guided aspiration for infected necrosis|endoscopic approach it was done to one patient in the form of EUS guided aspiration of pus in a case with infected necrosis followed by percutaneous US guided aspiration of the residual
15779777|NCT04615689|Other|The collection of feces|When the infants will be diagnosed with urinary tract infection, feces will be collected. Feces will be collected from healthy infants with informed consent.
15779778|NCT04615676|Other|Follow-up phone call|Follow-up phone call after month to detect which patient have been hospitalized
15779779|NCT04615663|Behavioral|Score SMI|the investigator will complete the SMI score
15779780|NCT04615650|Procedure|Surgical treatment|Surgical treatment of suprasyndesmotic ankle fractures
15779781|NCT04615650|Device|Ankle orthosis|Non-surgical treatment of suprasyndesmotic ankle fractures
15779787|NCT04615598|Behavioral|Action observation|The idea is to show some videos with the aim of improving patients' tongue strength.
15779788|NCT04615598|Behavioral|Placebo group|The idea is to show some videos of vegetation with the aim of having an intervention time but ineffective.
15779789|NCT04615585|Other|Aloe vera after SRP|Subgingival administration of Aloe vera gel was preceded by flushing the area with saline to wash away any debris. Aloe vera (1cc) gel was applied subgingivally using atraumatic needle. Patients were instructed not to rinse or drink any liquid for at least 30 minutes. The application was performed at baseline and after 1 and 2 weeks.
15779790|NCT04615585|Procedure|Scaling and root planing (SRP)|Removal of supragingival and sub-gingival calculus and debris was performed, followed by smoothing root surfaces and removing cementum or dentine that is impregnated with calculus and toxins.
15779791|NCT04615559|Diagnostic Test|Contrast enhanced ultrasound|CEUS involves the use of microbubble contrast agents and specialized imaging techniques to enhance the signal from blood, thus showing flow in macroscopic vessels as well as tissue perfusion information
15779792|NCT04615546|Behavioral|Use of Continuous Glucose Monitor (CGM)|Participants will wear CGM
15779793|NCT04615546|Other|Use of Cardea Solo monitoring|Participants will wear a Cardea Solo patch during blinded CGM use
15779794|NCT04615533|Other|Frail older adults, assessment|Frail'BESTest, Clinical Frailty Scale, Mini BESTest, Berg Balance Scale, Tinnetti Balance and gait sacale
15779795|NCT04615494|Procedure|Position|Pneumoperitoneum with Steep Trendelenburg position
15779796|NCT04615481|Other|Elliptical Training Group|The training program will be consisted of total 30 minutes of elliptical cross training (5 minutes warm up + Progressive Training up to 20 minutes of elliptical cross training + 5 minutes cool down) for 3 days in a week for 4 weeks at an average intensity of 50-70% the maximal heart rate according to ACSM guidelines.
15779797|NCT04615481|Other|Ergo-metric Training Group|The training program will be consisted of total 30 minutes of ergometric training (5 minutes warm up + Progressive Training up to 10 minutes of upper limb ergometric training + Progressive Training up to 10 minutes of lower limb ergometric training+5 minutes cool down) for 3 days in a week for 4 weeks at an average intensity of 50-70% the maximal heart rate according to ACSM guidelines.
15779798|NCT04615468|Drug|TQ-B3525|TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle.
15779799|NCT04615455|Drug|ASCs|ASCs expanded from healthy donors. The ASC product contains 22 million ASCs/ml.
15779800|NCT04615455|Drug|Cryostor CS10|CryoStor® CS10 freeze medium
15779801|NCT04615442|Device|Epihunter|Subjects wear epihunter during routine video EEG
15779802|NCT04615429|Biological|Mesenchymal stromal cells|Administration of one single dose of allogenic Mesenchymal stromal cells
15779803|NCT04615429|Other|Placebo|Administration of placebo (solution identical to experimental treatment, without the MSC)
15779804|NCT04615416|Behavioral|Emotion Regulation Training via Telehealth|The initial stage of treatment focuses on psychoeducation about anxiety/depression, the impact that these cognitions/behaviors/emotions have on recent situations, and self-monitoring of worry/anxiety/depression. The sessions focus on the development of skills that help understand and regulate one's emotional experience (i.e., recognizing emotions when they are happening, identifying the meaning of a given emotion experience, soothing oneself in the context of negative emotional experiences). Following the development of these skills, sessions focus on the application of somatic awareness and emotion regulation skills while imagining emotionally evocative themes. The remaining session focuses on terminating therapy, relapse prevention, and future goals. An Internet-based online platform will be used to promote engagement with and increase accessibility to between-session skills practice and treatment-related activities (e.g., self-monitoring, session summaries, worksheets).
15779805|NCT04615403|Drug|Travoprost|Implantation and exchange of a Travoprost Intraocular Implant through a clear corneal incision
15779806|NCT04615390|Behavioral|Early rehabilitation|The intervention is primarily focused on the recovery of mobility and functional autonomy. The treatment sessions are dependent on the patient's exercise tolerance.
15779807|NCT04615390|Behavioral|Subacute rehabilitation|Comprehensive intensive rehabilitation in the hospital
15779808|NCT04615390|Behavioral|Mindfulness training|The home mindfulness training consists of 2 parts: 1) explanation and reflection of the Mindfulness practice 2) formal and informal practice.
15779809|NCT04615390|Behavioral|Personalized ambulatory training|Low-intensity walking exercises at home
15779810|NCT04615377|Behavioral|Kaia hip and knee pain application|The Kaia Knee and Hip pain app software, when loaded onto a smartphone, recommends to the participant specific exercises for the lower extremity. Using the camera on a smartphone, the software then tracks the participant's movements as the participant performs the exercises, analyzes those movements using machine learning, and provides audio-visual feedback to the participant. The exercise therapy is augmented by educational content and cognitive behavioral therapy to provide a multidisciplinary approach to self-management of osteoarthritis. Behavioral Health Coaches ensure participant motivation throughout the program based on a predefined curriculum.
15779811|NCT04615377|Other|Treatment as usual|Participants allocated to the control arm will be advised to continue receiving treatment as usual ( standard care) without restrictions, except participation in other investigational trials, and will likewise be followed up for 90 days. Apart from that, they are encouraged to seek care, as they would do normally.
15779812|NCT04615351|Drug|Metformin|Medication
15779814|NCT04615325|Drug|RO7303359|RO730359 will be administered at a single intravitreal injection
15779815|NCT04615312|Drug|a CDK4 / 6 inhibitor and a MEK inhibitor|Participant will receive a CDK4 / 6 inhibitor and a MEK inhibitor treatment to determine the maximum tolerated dose
15779816|NCT04615299|Device|Auricular acupuncture|Auricular or Battlefield acupuncture is an auricular therapy which has been in existence for centuries, with roots tied to Eastern Asian medicine.
15779817|NCT04615286|Other|Short course (2-3 weeks) of antibiotics|Shorter course of antibiotic than standard care of 4-6 weeks
15779818|NCT04615286|Other|Standard (long course) of antibiotics|4-6 weeks of antibiotics
15779819|NCT04615273|Drug|Lonapegsomatropin|Due to the different hGH dose requirements, depending on subject's age and concomitant use of oral estrogen, this trial has 3 dosing groups per arm, followed by gradual increasing dose titration to a target maintenance dose.
15779853|NCT04614961|Other|Lifestyle therapy - group|Group therapy
15779820|NCT04615273|Other|Placebo|The placebo for lonapegsomatropin drug product will contain the same excipients as lonapegsomatropin drug product but does not contain lonapegsomatropin itself. The placebo solution will be administered by SC injection via syringe and needle. Due to the different hGH dose requirements, depending on subject's age and concomitant use of oral estrogen, this trial has 3 dosing groups and the placebo will receive the same dose volume as if they would have been randomized to once-weekly lonapegsomatropin.
15779821|NCT04615273|Drug|Somatropin|Somatropin solution is provided in a pre-filled pen intended for daily subcutaneous injection. Due to the different hGH dose requirements, depending on subject's age and concomitant use of oral estrogen, this trial has 3 dosing groups per arm, followed by gradual increasing dose titration to a target maintenance dose.
15779822|NCT04615260|Device|NanoBone|Nanobone® Synthetic Bone Graft is a nanocrystalline hydroxyapatite imbedded in a silica gel matrix. The nanocrystalline structure accurately replicates autologous hydroxyapatite and the silica gel matrix that rapidly transforms into an osteogenic matrix post-implantation. NanoBone promotes remodeling by acting as a strong osteoinductive material. NanoBone® is available as a putty.
15779823|NCT04615247|Other|Yoga Program|The yoga program is designed to maximize women's awareness of and control over the pelvic floor, promote relaxation, and improve physical function.
15779824|NCT04615247|Other|Physical Conditioning Program|The physical conditioning program will focus on a core set of exercises designed to improve physical function and emotional well-being in order to improve management of chronic pain.
15779825|NCT04615234|Device|Pharmacogenomics test (PGx)|"The clinicians of the TGTG group patients receive the PGx test report within 48 hours and all the participants start the new treatment within 72 hours. According with both Clinical Pharmacogenetics Implementation Consortium (CPIC) and the Dutch Pharmacogenetics Working Group (DPWG) guidelines, the PGx report places the most ADs widespread in Italy, into three recommended categories: 1) use as directed (labelled as Green), 2) use with caution (labelled as Yellow), 3) use with extreme caution (labelled as Red)"
15779826|NCT04615221|Other|Specimens|Specimens (blood, biopsy, cervical smear, vaginal swab)
15779827|NCT04615208|Diagnostic Test|suspected of COVID-19 infection|suspected of COVID-19 infection
15779828|NCT04615195|Other|cries 13 questionnaire|"Participant will be contacted by telephone by a clinical research assistant to answer the CRIES 13 questionnaire.
~In large families, the CRIES-13 of the holder of parental authority and of the child will be applied for each of them whose age corresponds to the inclusion criteria."
15779829|NCT04615182|Device|Transplant|To enable continued clinical access to DCD heart transplantation in the U.S. and to continue to collect additional data on the performance of the OCS Heart System to resuscitate, preserve and assess hearts donated after circulatory death for transplantation to increase the pool of donor hearts available for transplantation.
15779830|NCT04615169|Behavioral|Multi-component cognitive intervention with simulated everyday tasks (MCI-SET)|"2 hours per session: consisted primarily of modified everyday cognitive tasks, which were adjusted for individuals and for the group by the group leader to provide an error-reduction learning environment. Each session consisted of: (1) Warm-up: a 15-30 minute dual task of motor-cognitive exercises that increase arousal level and provide cognitive stimulation. For example, at the beginning of the group, the members would sing a song, mimic dance movement of the group leader, and clap hands when specific words occur in the song.
~(2) 30-minutes guided and repetitive practices of contextually-relevant simulated everyday cognitive tasks with one 15 to 20- minute break in between; Cognitive tasks addressed complex attention, visual scanning, auditory attention, visual and motor memory, auditory memory, prospective memory, executive functioning, problem solving, etc."
15779831|NCT04615156|Drug|18F-2-fluoro-2-deoxy-D-glucose|Administration of 18F-2-fluoro-2-deoxy-D-glucose for the purposes of diagnosis.
15779832|NCT04615143|Drug|Tislelizumab|Patients receive Tislelizumab on week 1 and week 4 (200mg, iv, q3w). After 2 cycles of Tislelizumab and evaluation of resectability, patients will receive surgery in 6 weeks after enrollment. Patients will receive Tislelizumab for 1 year (200mg, iv, q3w, 17 cycles) in 4-6 weeks after surgery.
15779833|NCT04615130|Other|Rehabilitation|Rehabilitation, exercise training
15779834|NCT04615104|Procedure|Operative|surgical treatment
15779835|NCT04615104|Procedure|Nonoperative|nonsurgical treatment
15779836|NCT04615078|Device|ETAPES Program|"The Chronic Care Connect Pneumology is a remote medical monitoring solution, combining:
~A technical solution for the transmission and analysis of ventilator data, leading to alerts generated by an algorithm ;
~An organizational solution relying on a nurse call center."
15779837|NCT04615052|Other|Exercise training|A 12 weeks parallel-group randomised controlled trial will be performed, in which covid-19 survivors patients will complete a telemonitored home-based exercise training program, 3 times per week. The training program will involve strength, aerobic, balance and flexibility exercises.
15779838|NCT04615039|Device|PROFEMUR® Preserve Classic Femoral Stem|Single study group of subjects, either newly or previously implanted with the PROFEMUR® Preserve Classic Femoral Stem combined with any type of polyethylene and ceramic acetabular shells, acetabular liners and femoral heads.
15779839|NCT04615026|Diagnostic Test|duplex sonography|all patients with consent receive a duplex ultrasound, blood test, cognitive test and test of smelling
15779840|NCT04615013|Drug|Capecitabine|Not applicable to this study
15779841|NCT04615013|Drug|Carboplatin|Not applicable to this study
15779842|NCT04615013|Drug|Docetaxel|Not applicable to this study
15779843|NCT04615013|Drug|Fluorouracil|Not applicable to this study
15779844|NCT04615013|Other|Hafnium Oxide-containing Nanoparticles NBTXR3|Given IT or IN
15779845|NCT04615013|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
15779846|NCT04615013|Drug|Leucovorin|Not applicable to this study
15779847|NCT04615013|Drug|Oxaliplatin|Not applicable to this study
15779848|NCT04615013|Drug|Paclitaxel|Not applicable to this study
15779849|NCT04615000|Diagnostic Test|SARS-CoV-2 serological assessment (IgG)|Periodic assessment of the serology status (SARS-CoV-2 specific IgG) with a 3 to 6 month interval
15779850|NCT04614974|Drug|Famotidine|Famotidine will be prescribed based on patients' weight. Caregivers will purchase this medication and dosage will be given to families in easy-to-understand language.
15779851|NCT04614974|Other|Speech Language Therapy|Speech Language Therapy (feeding therapy) will be provided by a speech language pathologist to assess feeding and swallowing.
15779852|NCT04614961|Other|Lifestyle therapy - individual|Individual therapy
15779856|NCT04614948|Biological|Ad26.COV2.S|Ad26.COV2.S vaccine will be administered on Day 1 and Day 57 in the double-blind phase. At unblinding visit Ad26.COV2.S vaccine will be administered to participants at Day 57 who have not yet received second vaccination and in newly enrolled participants as either single dose on Day 1 or two doses on Day 1 and Day 57. Single dose of Ad26.COV2.S vaccine will also be administered to participants initially receiving placebo.
15779857|NCT04614948|Other|Placebo|Placebo will be administered as IM injection on Day 1 and Day 57.
15779858|NCT04614935|Behavioral|Action Plan|See arm description.
15779859|NCT04614922|Behavioral|Acceptance and Commitment Therapy|ACT-based rehabilitation is an interdisciplinary group rehabilitation which includes 7 sessions of group-based ACT therapy. Each session lasts 2½ hours and is offered twice a week. The ACT sessions will be based on a detailed intervention manual, developed specifically for group treatment. Each group will include a maximum of eight patients. The patients are asked to do homework between each ACT-group session.
15779860|NCT04614922|Behavioral|Care as usual|a phone call from a therapist for counselling and psychological support
15779861|NCT04614909|Drug|Pamiparib|60mg administered orally BID for 4 days prior to surgical resection
15779862|NCT04614909|Drug|Olaparib|200mg administered orally BID for 4 days prior to surgical resection
15779863|NCT04614909|Radiation|Radiation therapy|Patients in Phase 2 will receive 6-7 weeks of radiation therapy per standard of care
15779864|NCT04614909|Drug|Temozolomide|Arm A and Arm B participants after RT is completed, will receive pamiparib in combination with TMZ (newly diagnosed participants). Arm C participants will receive olaparib with TMZ.
15779865|NCT04614896|Diagnostic Test|Transoral ultrasound of tongue tumors|A transoral ultrasound scan of tongue tumors will be performed to assess the depth of invasion of the tumor
15779866|NCT04614883|Device|Volatile Organic Compounds analysis|VOC analysis in exhaled air with e-noses and mass spectrometry. VOC analysis in sweat with mass spectrometry.
15779867|NCT04614883|Other|Canine odor detection of Volatile Organic Compounds|VOC analysis in sweat by trained dogs.
15779868|NCT04614870|Diagnostic Test|DETEC® Esterase|DETEC® Esterase is a disposable diagnostic device that is used to indicate the presence or absence of infection based on the presence or absence of the evaluated level of leukocyte esterase by testing the freshly recovered wound dressing which are soaked with wound exudate.
15779869|NCT04614857|Other|Inclined treadmill gait|All subjects underwent measurements of muscle activity and respiratory metabolism energy during treadmill walking at a comfortable speed for 5 minutes and measured by three conditions (#0% inclined treadmill gait, #10% inclined treadmill gait, and #16% inclined treadmill gait)
15779870|NCT04614844|Behavioral|Simulation Intervention|Participants randomized to the intervention arm will receive CRI:SIS as a three-hour simulation session.
15779871|NCT04614844|Behavioral|Control|Participants randomized to the control arm will participate in four shift data collections, with no additional intervention.
15779872|NCT04614818|Other|Non-intervention research|Non-intervention research
15779873|NCT04614805|Behavioral|Mobilizing clinical leaders|Clinical leaders and clinical personnel will regularly receive feedback regarding performance of their own hospital as well as other providers in the regional health trust of North Norway.
15779874|NCT04614792|Device|Transcranial direct current stimulation|Non-invasive brain stimulation or neuromodulation.
15779875|NCT04614779|Drug|CN128 Tablets|Iron chelator, oral tablets
15779876|NCT04614766|Drug|Lutathera|intravenous administration
15779877|NCT04614766|Drug|Azedra|intravenous administration
15779878|NCT04614753|Other|Muscadine Wine|Red muscadine wine
15779879|NCT04614753|Other|Sprite|Sprite
15779880|NCT04614740|Drug|VC004|20 mg table,50 mg table,100 mg table.
15779881|NCT04614727|Combination Product|polymeric nano calcium fluoride containing varnish NANO SEAL|It consists of four components Silicone polymer provides excellent adhesion to enamel and dentine, with transparent formula. NANO-fluoroapatite flows into enamel micro cracks & seals it, penetrating into the dentinal tubules closing them eventually. As for the NANO-calcium fluoride it behaves as a fluoride reservoir, provides gradual and long-term fluoride release. The fourth component Amine fluoride (Olaflur) provides immediate fluoride ion release and accelerates natural remineralization.
15779882|NCT04614714|Drug|Nicotinamide riboside chloride|Nicotinamide riboside chloride 250 mg capsules, administered once per day (Day 1-7 or Day 11-17)
15779883|NCT04614714|Drug|Placebo|Maltodextrin placebo, administered once per day (Day 1-7 or Day 11-17)
15779884|NCT04614701|Procedure|Carotid Artery Ultrasound Measure|"Cardiac output will be assessed by measuring the LVOT diameter in parasternal long-axis window and the LVOT VTI in apical-four window. Carotid artery flow will be measured on the right neck 1-2cm from the bifurcation of the common carotid artery. All measurements will be taken with participants supine and the head of the bed elevated to 45°. measures all at 3 minute intervals.
~One-leg compression test: Thigh-sized blood pressure cuff inflated to 60mmHg on middle part of one thigh for 60 seconds. LVOT and CCA measurements taken separately.
~Two-leg compression test: Thigh-sized blood pressure cuff inflated on middle part of both thighs for 60 seconds. LVOT and CCA measurements taken separately.
~Passive leg raise test: Bed adjusted to place participant at 0° and legs elevated at 45° by use of pillows. After 1 minute, measurements repeated. LVOT and CCA measurements taken separately."
15779885|NCT04614688|Behavioral|Patient Education Platform|The patient education platform for hysteroscopy surgery is a website platform which has patient education materials regarding hysteroscopy procedures in the format of pictures, videos, and text. Information on this platform includes anatomy of the surgery area, what to expect, reasons for the surgery, ways to prepare for the surgery, and recovering from the surgery.
15779886|NCT04614675|Procedure|Distal soft tissue procedure with TALR|TALR group: Transarticular lateral release as the distal soft tissue procedure
15779887|NCT04614675|Procedure|Distal soft tissue procedure with PCLR|PCLR: Percutaneous soft tissue procedures as the distal soft tissue procedure
15779888|NCT04614662|Behavioral|SPARK Symptom Screening Linked to Feedback to Providers|Symptom screening three times weekly via SPARK, feedback of symptoms to healthcare providers and development of care pathways for symptom management.
15779889|NCT04614636|Drug|FT538|Experimental Interventional Therapy
15779890|NCT04614636|Drug|Cyclophosphamid|Lympho-conditioning Agent
15779891|NCT04614636|Drug|Fludarabine|Lympho-conditioning Agent
15779892|NCT04614636|Drug|Daratumumab|Monoclonal Antibody
15779894|NCT04614623|Device|AHCL pump|Advanced Hybrid Closed Loop (AHCL) pump automatically adjusts insulin infusion rate of pump customized to patient's needs to reduce occurrence of hypo and hyperglycemia
15779895|NCT04614623|Other|Video conferencing Application|Video conferencing application will be used to enhance communication between participant and parent with the study certified diabetes educator (CDE) nurse coordinator. These individualized sessions will be designed to help the family with solving diabetes management problems to enhance glycemic control
15779896|NCT04614610|Drug|Lidocaine Iv|Lidocaine 1.5mg/kg (Max dose: 200mg) in Dextrose 5% 100mL over 10 minutes
15779897|NCT04614610|Drug|Placebo|Dextrose 5% 100mL over 10 minutes
15779898|NCT04614597|Biological|Sabin strain inactivated polio vaccine|Sabin IPVs have been given to participants in previously study, blood specimens will be collected once all the subjects reach the age of 18months.
15779899|NCT04614584|Drug|Mirtazapine|Mirtazapine 30 mg PO daily x 4 days
15779900|NCT04614584|Drug|Methamphetamine|Methamphetamine 30 mg IV once
15779901|NCT04614571|Dietary Supplement|Gluten Powder|Administered orally daily for 14 days
15779902|NCT04614558|Drug|Isatuximab|"Isatuximab in IV form (10mg/kg q weekly x 4 doses followed by 10mg/kg q 2 weeks) for a total of 6 month duration. Doses should be initiated at 175 mg/hour up to a maximum of 400 mg/hour.
~Isatuximab (SAR) is monoclonal antibody (mAb)."
15779903|NCT04614545|Drug|Phentermine 37.5 Mg|Patients will receive 37.5 mg of phentermine daily for a 12 week duration
15779904|NCT04614545|Behavioral|Dietary program|Patients will be able to select either the Mediterranean diet or the Ketogenic diet and will work with a dietician
15779905|NCT04614545|Behavioral|Exercise program|Patients will be provided with a personalized exercise program
15779906|NCT04614532|Diagnostic Test|cognitive assessment|"global cognitive assessment :
~Mini Mental State
~Evaluation of manual laterality
~Hospital Anxiety and Depression scale
~5 words of Dubois
~Trail Making Test
~short battery of the praxies
~neuropathic pain scale (DN4 in french)
~Analog Visual Scale for pain
~Fast Front End Efficiency Battery"
15779907|NCT04614532|Other|Cold Pressor Test|"consists of the complete immersion of the participant's arm in a basin of cold water maintained at a temperature.
~The test will be divided into two conditions (pain, no pain). In the first, the container will be filled with cold water. In the second, the water in the container will be at room temperature. The investigators will test each arm. During the immersion of the arm, participants will have to remain silent and remove their arm when the ordeal becomes too painful for the painful condition.
~For the non-painful condition, the immersion time will be determined according to the results of the pre test."
15779908|NCT04614532|Other|digital sensor of Nociception Level Index|placed on the contralateral index finger with the arm immersed in the tank to measure the variation of physiological parameters.
15779909|NCT04614519|Procedure|Conventional group|Insufflation pressure at 12mmHg and conventional instrumentation
15779910|NCT04614519|Procedure|Low impact laparoscopy group|Insufflation pressure at 7mmHg and micro-laparoscopy instrumentation
15779911|NCT04614506|Device|Transcranial Magenetic Stimulation (TMS)|Transcranial magnetic stimulation (TMS) is a method for noninvasive electrical cortical stimulation, where small intracranial currents are generated by a powerful, fluctuating, extracranial magnetic field. TMS is unique in its capacity for experimental, diagnostic, and therapeutic utility. Single pulse (spTMS) and paired-pulse TMS (ppTMS) have been used extensively to study, measure, and modulate cortical excitability and plasticity.
15779912|NCT04614506|Device|Electroencephalogram (EEG)|These will be an ambulatory EEG recordings that span 24 hours and done without sedation. Recordings will be performed using electrode locations specified by the international 10-20 system for standard clinical practice.
15779913|NCT04614493|Device|SonoCloud-9 (SC9) device|"daily temozolomide (TMZ) during Radiation, followed by 6 months of adjuvant TMZ (5 days/months) with 6 concomitant Blood Brain Barrier opening sessions by ultrasound
~+ 9 Blood Brain Barrier opening sessions by ultrasound without any associated drug"
15779914|NCT04614493|Drug|Temozolomide according Stupp protocol|daily temozolomide (TMZ) during Radiation, followed by 6 months of adjuvant TMZ (5 days/months)
15779915|NCT04614467|Biological|CLBS16|GCSF-mobilized autologous CD34+ cells
15779916|NCT04614467|Biological|Placebo|isotonic solution (no CD34+ cells)
15779917|NCT04614454|Device|High Frequency Impulse Therapy|The home TENS unit device is an at-home transcutaneous electrical nerve stimulation unit in that it provides non-invasive transcutaneous electrical impulses to reduce pain. It is a small, wearable device that utilizes both high and low frequencies to create a nerve-block effect based on the same gating theory.
15779918|NCT04614454|Device|High Frequency Impulse Therapy - Sham|This device looks like the experimental device but does not provide the electrical current.
15779919|NCT04614441|Drug|OFEV®|nintedanib
15779920|NCT04614428|Behavioral|RESILIENCE Program|"In addition to the standard care participants would normally receive (including exposure to any standard hospital avoidance programs), the 150 participants assigned to the RESILIENCE Program group will receive a combination of strategies designed to promote seasonal resilience.
~This includes profiling of seasonal vulnerability; a 60-80 minute home visit by the RESILIENCE Nurse to assess physiological status, behavioural adaptations, environment, and modulating factors; a dedicated RESILIENCE Clinic with a dedicated RESILIENCE physician to develop a long-term plan to help promote/maintain seasonal resilience and; a structured follow-up over the next 12 months to monitor and adjust the participant's status and management from a seasonal perspective."
15779921|NCT04614415|Device|Autocrosslinked Hyaluronic aid|IAL-SYSTEM ACP gel is an auto-cross-linked HA derivative in the form of highly viscous gel. In this direct formation of ester linkages no foreign substances are introduced into the molecule, thus catabolism of ACP leads only to HA
15779922|NCT04614415|Other|placebo|The placebo consists in an isotonic saline solution (NaCl 0.9%)
15779923|NCT04614402|Device|Edwards PASCAL Transcatheter Valve Repair System|The Edwards PASCAL Valve Repair System is indicated for the percutaneous reconstruction of an insufficient tricuspid valve.
15779924|NCT04614389|Other|Contrast-enhanced ultrasound|Non Invasive Imaging Technique. CEUS involves the use of microbubble contrast agents and specialized imaging techniques to enhance the signal from blood, thus showing flow in macroscopic vessels as well as tissue perfusion informatio
15779986|NCT04613882|Device|Soft Toric Custom Made Contact lens|Subjects will be randomized to wear soft toric custom made lenses for 30 minutes in one eye with other eye patched.
15779925|NCT04614389|Other|Shear Wave Elastography|Non Ivasive Imaging Technique. Shear Wave Elastography (SWE) is a recently developed technique that uses ultrasound to noninvasively assess the mechanical stiffness of tissue by measuring tissue distortion in ponse to an acoustic radiation force impulse from a focused ultrasound beam.
15779926|NCT04614389|Device|Sequoia System|UltraSound System Cleared by FDA 510 (k) K180067
15779927|NCT04614363|Drug|68Ga-PSMA|All subjects enrolled in the study will receive a single IV dose of 3-7 mCi of 68 Ga-PSMA (study drug) followed by PET/CT imaging for detection of tumor location.
15779928|NCT04614350|Biological|Markman Biologics Microsurfaced ADM|an ADM which has been scored (microsurfaced)
15779929|NCT04614350|Biological|AlloDerm|AlloDerm tissue matrix
15779933|NCT04614311|Drug|Triamcinolone Hexacetonide 20 MG/ML|JIA patients (age 1-18 years) starting TNFi treatment randomised to intervention will receive treatment with intra articular glucocorticoids (triamcinolone hexacetonide) injections in inflamed joints
15779934|NCT04614298|Drug|KHK4827-Active|Single SC administration
15779935|NCT04614298|Drug|KHK4827-Placebo|Single SC administration
15779936|NCT04614285|Procedure|Partial excavation|"Operators sign up for participation at the homepage of Center for Pediatric Oral Health Research (ABC). The study will be carried out in a Practice-Based Research Network setting. All practitioners interested in participating in the study will get access to an online information about their participation after they signed up. The participation starts by answering a questionnaire on their treatment attitudes and experiences.
~Patients will be identified during the routine dental examination. If a carious lesion in the primary molars is detected and in a need of a restoration, the children and parents will be asked to participate in the study.
~The parents receive information about the study and give their consent. Allocation into treatment groups will be performed by random assignment by the homepage of ABC.
~After the study is finished the participating dentist will be asked to answer the same questionnaire to investigate the effect of the participation on the operators attitude."
15779937|NCT04614272|Behavioral|Prayer|Prayer is a non-pharmaceutical method of pain management and a form of alternative medicine.
15779938|NCT04614272|Behavioral|Reading a poem|Reading is a distraction tool for pain management
15779939|NCT04614259|Drug|Bupivacain|"The infraorbital foramen was located at the floor of the orbital rim at about the level of the pupil,The upper lip was folded back and a finger is placed externally at the level of the infraorbital foramen to prevent the needle from the cephalad insertion in the globe of the eye. A 27-gauge needle was bent about 70 degree to ease the insertion through the buccal mucosa over the maxillary process, towards the infraorbital foramen.
~After careful aspiration the local anesthetic was injected (injection of 3 ml 0.25% bupivacaine in 1:200.000 adrenaline ,1.5 ml on each side). [104] Pressure was needed to be applied for one minute to the area as there is loose adventitious tissue that can lead to swelling and ecchymosis"
15779940|NCT04614259|Combination Product|i.v. analgesia|"Using inhalational induction with sevoflurane as tolerated , atracurium 0.5mg/kg to facilitate endotracheal intubation and fentanyl 1 mcg/kg ,Mechanical ventilation was adjusted to maintain 30 to 35 mmHg end-tidal carbon dioxide, anesthesia was maintained with 1.5 % isoflurane and atracurium (0.1 mg/kg every 30 minutes) ,all patients were received intraoperative diclofenac sodium 0.5 mg/kg intramuscular .
~Blood pressure and heart rate were measured 5 minutes after endotracheal intubation and every 15 minutes till recovery from the anesthesia then every 15 min in the postoperative care unite for 30 minutes"
15779941|NCT04614246|Drug|BAY1817080|Tablet, oral administration
15779942|NCT04614246|Drug|Elagolix|Tablet, oral administration
15779943|NCT04614246|Drug|Placebo|Tablet, oral administration
15779944|NCT04614233|Dietary Supplement|RiduZone (90% OEA)|Participants will be randomly assigned to take 2 capsules of RiduZone (each capsule contains 90% OEA ) daily for 16 months
15779945|NCT04614233|Other|Placebo|Participants will be randomly assigned to take 2 capsules of placebo daily for 16 months. Placebo capsules will consist of 180mg of hypromellose.
15779946|NCT04614220|Behavioral|Presence of Family member|The correlation between presence of the Family member and the consent for regional anaesthesia for Caesarean Section
15779947|NCT04614194|Drug|Letrozole|Oral. Tablets should be taken at the same times every day, with or without food.
15779948|NCT04614194|Drug|Abemaciclib|Oral. Tablets should be taken at the same times every day, with or without food.
15779949|NCT04614181|Dietary Supplement|Nestle Resource drink|Beverage (Nestle RESOURCE). Each serving is 237ml containing 53.6g of carbohydrate and 9g of protein. Intervention group will consume two servings of the carbohydrate beverage (53.6g each, total of approximately 100g) on the day before surgery and one serving up to 6 hours prior to scheduled surgery time.
15779950|NCT04614181|Other|Usual care|Usual fracture care as determined by clinical team
15779951|NCT04614168|Procedure|Stepped hyperinsulinaemic-hypoglycaemic clamp study|Participants will commence on a primed insulin infusion at a constant rate of 60mU/m2/min along with a variable rate 20% glucose infusion. Participants will have their blood glucose monitored every 5 minutes. The glucose infusion will be altered to achieve the desired blood glucose plateaus of: 5mmol/l, 3mmol/l and 2.5mmol/l. Each plateau will be held for 40 minutes. During each plateau blood samples will be taken on three occasions for: glucagon, cortisol, adrenaline, noradrenaline, D2 glucose and D5 glycerol. On two occasions during each plateau participants will complete the Edinburgh hypoglycaemia scale and the following cognitive tests: trail making test, digit span test, digit symbol substitution test and four choice reaction time test. At the end of the clamp study the insulin infusion will be discontinued and the blood glucose will be allowed to rise to the normal range. Participants will consume lunch before leaving the clinical research facility.
15779952|NCT04614168|Device|Insulin pump|Insulin pump with a built-in algorithm that allows it to work with a CGM device to adjust insulin delivery based on CGM readings.
15780015|NCT04613648|Diagnostic Test|Imaging|Ultrasonographic imaging of the shoulder
15779953|NCT04614168|Device|Continuous glucose monitor|Continuous glucose monitoring device that sends data to the insulin pump to allow the algorithm to adjust insulin delivery. Participants are able to see the glucose data from the device when it is used in open mode.
15779954|NCT04614168|Other|Low carbohydrate diet|30-40g of carbohydrate per main meal portion.
15779955|NCT04614168|Device|Blinded continuous glucose monitor|Allows data on blood glucose to be collected without values altering the behaviour of the participant. Participants have to continue to monitor their own blood glucose while wearing the device in the blinded mode.
15779956|NCT04614168|Procedure|Stable isotope studies- D2 Glucose and D5 Glycerol|These studies will take place at the same time as the hyperinsulinaemic hypoglycaemic clamp studies. Participants will receive a priming dose of each stable isotope followed by a continuous infusion for the remainder of the clamp study.
15779957|NCT04614155|Other|Educational Intervention|Take part in health education session
15779958|NCT04614155|Procedure|HPV Self-Collection|Receive HPV self-collection kit
15779959|NCT04614155|Other|Questionnaire Administration|Complete questionnaires
15779960|NCT04614142|Drug|Glecaprevir / Pibrentasvir Oral Tablet [Mavyret]|The subject will begin an 8 week course of therapy with glecaprevir (100mg) / pibrentasvir (40mg) starting on day 3 (+/- 2 days) post-kidney transplantation from a hepatitis C positive donor.
15779961|NCT04614129|Diagnostic Test|Low Dose CT|All participants will have a low dose chest CT either within one year of enrollment or after enrollment
15779962|NCT04614116|Other|External cooling|water-circulating cooling/warming sleeves connected to a medical cooling device (Hilotherm Clinic®, Hilotherm GmbH, Germany) will be placed around the subject's abdomen and lower back. Initially the temperature of the water will be set to 25°C. A mild cold stimulus will be applied by reducing the temperature of the circulating water by approximately 1°C every 2 minutes to a minimum of 10°C.
15779963|NCT04614116|Diagnostic Test|FDG PET/CT|o 75 MBq 18F-FDG will be injected through the intravenous line on the scanner manually (bolus injection) with a simultaneous start of dynamic FDG-PET/CT scan for 45 minutes and a partial body scan from head to the abdomen after 45 minutes. Total scan time 60 minutes.
15779964|NCT04614116|Diagnostic Test|13C-Glucose injection|0.5 g 13C-Glucose i.v. infusion over 5 minutes, after termination of FDG injection
15779967|NCT04614077|Other|ex vivo organ bath testing, preservation of vein sections without contact to patient|1 piece of vein is separated during surgical bypass procedure, then randomized and put ex vivo in two solutions: saline and specific solution, then tested in the organ bath
15779968|NCT04614064|Other|Exposure to London Underground ambient particulate matter|Exposure to particulate matter on the London Underground
15779969|NCT04614064|Other|Exposure to London air ambient particulate matter|Exposure to ambient particulate matter on the London Overground (as a proxy as a proxy for a clean air London area while maintaining other aspects of a train journey)
15779970|NCT04614051|Biological|Cellgram-DC|Patients will receive 3 times every 2 weeks injection of Cellgram-DC(Autologous dendritic cell) subcutaneous injection near the upper arm lymph nodes
15779971|NCT04614038|Diagnostic Test|DETEC® pH|DETEC® pH is a disposable diagnostic device that is used to indicate the alkalinity of the wound by testing wound exudate adsorbed onto wound dressing.
15779972|NCT04614025|Biological|PLX-PAD|PLX-PAD - allogeneic ex-vivo expanded placental mesenchymal-like adherent stromal cells
15779973|NCT04614012|Other|treated with hyperimmune plasma|administration of hyperimmune plasma at day 1 and based on clinical response on day 3 and 5
15779974|NCT04613999|Drug|Ralinepag|"Ralinepag will be supplied as 50 mcg round, orange, XR tablets for oral administration.
~It is planned that every subject will receive each of the following regimens in the fasted state:
~Regimen A (50 mcg): 1 × 50 mcg ralinepag XR tablet
~Regimen B (100 mcg): 2 × 50 mcg ralinepag XR tablets
~Regimen C (150 mcg): 3 × 50 mcg ralinepag XR tablets Subjects will receive Regimens A, B and C in a sequential manner in consecutive treatment periods. Subjects who have tolerated the IMP in all prior regimens will continue in the study to receive each subsequent dose."
15779975|NCT04613986|Device|therapeutic plasmaexchnage|established method to exchange plasma (in order to remove injurious disease mediators, e.g. antibodies) or to replace consumed factors (e.g. vWF cleaving proteases)
15779976|NCT04613960|Drug|Magnesium sulfate|MgSO4 (at a fixed daily dose of 64 mmol reconstituted in 0.9% saline) via continuous intravenous infusion for 14 days after onset
15779977|NCT04613960|Drug|normal saline|Placebo treatment
15779978|NCT04613947|Behavioral|Informed consent|The style of informing patients about the procedure they will undergo
15779979|NCT04613947|Procedure|Third molar surgery|Surgical extraction of the third molar tooth
15779980|NCT04613921|Other|Observational Protocol|The cohorts will be followed for one year after LT transplantation except for group 3 (1-year follow-up after inclusion)
15779981|NCT04613908|Device|neuro muscular electro stimulation|We used a commercial equipment of electro stimulation with a pulse width of 300 micro seconds, a frequency of 50 Hz, with symmetrical balanced biphasic rectangular wave and with an intensity of up to 80 milliampere.
15779982|NCT04613908|Other|Early Mobilization protocol|"The protocol consisted in applying a specific treatment based on different levels of treatment to each subject. Admission to them was carried out according to the maximum capacity of each subject, the conditions of each level being the following:
~Level 1: MRC (shoulder) <3 + MRC <3 (hip).
~Level 2: MRC (shoulder) ≥ 3 + MRC (hip) <3.
~Level 3: MRC (shoulder) ≥ 3 + MRC (hip) ≥ 3 + sitting on the edge of the bed without assistance (minimum 15 minutes).
~Level 4: Standing without assistance and walking with or without assistance."
15779983|NCT04613908|Other|standard care or usual rehabilitation|routine, non-protocolized rehabilitation treatment performed by the physiotherapist assigned to intensive care
15779984|NCT04613895|Drug|DWP14012|DWP14012 40 mg, orally, once daily just after a meal up to 4 weeks
15779985|NCT04613895|Drug|DWP14012|DWP14012 40 mg, orally, once daily before a meal up to 4 weeks
15779987|NCT04613882|Device|Soft Spherical Contact Lenses|Subjects will be randomized to wear soft spherical contact lenses for 30 minutes in one eye with other eye patched.
15779988|NCT04613882|Device|Spectacle Correction|Subjects will be randomized to wear spectacle Correction for 30 minutes in one eye with other eye patched.
15779989|NCT04613869|Drug|High-dose Esketamine hydrochloride+Hydromorphone|By adding different doses of esketamine to the postoperative analgesic pump, and the control group without adding this drug to observe the postoperative pain, anxiety and depression indicators of the surgical patients
15779990|NCT04613869|Drug|Low-dose Esketamine hydrochloride+Hydromorphone|By adding different doses of esketamine to the postoperative analgesic pump, and the control group without adding this drug to observe the postoperative pain, anxiety and depression indicators of the surgical patients
15779991|NCT04613869|Drug|Hydromorphone|No esketamine added
15779992|NCT04613856|Other|Hydration protocol - 237 mL water bolus|Subjects consume 237 mL of water every 20 minutes during 2 hours of high intensity work in the heat.
15779993|NCT04613856|Other|Hydration protocol - 500 mL water bolus|Subjects consume 500 mL of water every 40 minutes during 2 hours of high intensity work in the heat.
15779994|NCT04613843|Other|Water Stirring|Following an active heating protocol, the cooling intervention includes vigorous water stirring throughout cold water immersion.
15779995|NCT04613843|Other|No Water Stirring|Following an active heating protocol, the cooling intervention includes no water stirring throughout cold water immersion.
15779996|NCT04613830|Drug|Bupivacaine Hydrochloride|The patient will be placed in a sitting position under complete aseptic condition and a cover sheath will be used for the ultrasound probe with an appropriate amount of lubricating gel applied on the probe, a high-frequency linear ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T7 spinous process. This should reveal three muscles superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. then injecte bupivacaine hydrochloride
15779997|NCT04613830|Drug|Tramadol hydrochloride|Patients in group Tramadol will intravenously administrate dose of 1 mg/kg/8hr tramal to be increased upon patient needs up to 2mg/kg/6hr as rescue analgesic
15779998|NCT04613804|Drug|Toripalimab Injection|"Qualified subjects will be treated with toripalimab 240mg q21d as a treatment cycle."
15779999|NCT04613791|Biological|Blood test|Collection of epidemio-clinical, biological, radiological and therapeutic patient data
15780000|NCT04613778|Procedure|Laser acupuncture|Laser acupuncture is a low-level laser technique with no invasive procedure
15780001|NCT04613765|Behavioral|Measure adherence behaviors|"Conducted in the ambulatory setting of two Brussels hospitals, the MADESIO mixed-method study design combine sequentially a first quantitative explorative questionnaire-based study with a second in depth qualitative approach.
~The first 4 visits questionnaire-based survey prospectively measures adherence to OAMs and identify associated risk factors in the two sub-groups of ambulatory patients with various haematological malignancies. A combination of validated self-reported measures able to measure medication taking behaviours, assess both intentional and unintentional adherence, identify associated risk factors was selected.
~The second qualitative phase, based on the McGill Illness narrative interview design, deeper address patients' therapeutic adherence and subjective meanings."
15780002|NCT04613752|Device|diaphragmatic function measurements and diaphragmatic ultrasound|A single experimental group in which diaphragmatic function measurements and diaphragmatic ultrasound will be performed.
15780003|NCT04613739|Behavioral|insurance navigation|Intervention subjects will be offered access to AAFA's chat bot and navigation services. The chat bot is an artificial intelligence-enabled interactive online tool that can answer clinical and insurance-related questions and provide information on coverage options and how to find lower-cost alternatives for asthma care. Intervention participants will be given a link to access the chat bot. They will also be provided with information about AAFA's insurance navigation program, how it can help with finding coverage and managing asthma costs, and how to access it within AAFA's asthma community platform. Subjects can access AAFA's community platform and join the private group where they can ask questions and share resources, with moderation by AAFA staff. They will be able to send private messages to an AAFA navigator who can provide support about insurance issues, access to asthma care, and assistance with asthma costs. The navigator will offer telephonic follow-up as needed.
15780004|NCT04613726|Drug|ondansetron|group consisted of receiving IV 8 mg ondansetron diluted in 10 ml of normal saline
15780005|NCT04613726|Drug|Granisetron|Another comparator group consisted of receivingIV 3 mg granisetron diluted in 10 ml of normal saline
15780006|NCT04613726|Drug|Saline|Control group consisted of patients receiving IV 10 ml normal saline
15780007|NCT04613713|Other|Somatocognitive physiotherapy|"The main intervention areas include:
~education about the PVD, healthy vulvo-vaginal and sexual behaviors, nature of chronic pain and factors influencing pain intensity
~bodily exercises and techniques increasing body awareness, ability to relax and control muscle tension and respiration pattern in different situations
~techniques to cope with emotions and thoughts related to bodily experiences and to PVD
~structured homework assignments promoting application of the learned techniques in daily situations and gradual exposure of the patient to activities associated with pain.
~Participants will be offered maximally 15 treatment sessions. No minimal number of sessions is set. Treatment will be conducted by female physiotherapists experienced in treating long-standing pain conditions."
15780008|NCT04613713|Other|Treatment as usual|The participants will follow the current treatment advice as recommended by the Vulva Clinic at OUH, a tertiary health care center specialized in treatment of vulvar disorders. Advice include guidance about the management of PVD as a condition, use of medication, physiotherapy, sexologist and psychological counseling, usage of internet resources (vulva.no) and others. Participants will be free to pursue treatment options of their choice. The type of treatment, number of treatments and medication usage will be monitored by bi-weekly electronic forms during the whole study period.
15780009|NCT04613700|Drug|Secretin|Native hormone
15780010|NCT04613700|Other|Placebo|Saline
15780011|NCT04613687|Device|Compression bandage|Compression bandage URGO BD001 for the management of venous leg ulcers with ABPI (Ankle Brachial Pressure Index) ≥ 0.8, venous
15780012|NCT04613674|Drug|Camrelizumab Plus Chemotherapy|camrelizumab+chemotherapy
15780013|NCT04613674|Drug|placebo+chemotherapy|placebo+chemotherapy
15780014|NCT04613661|Other|Australian Spasticity Assessment Scale|Australian Spasticity Assessment Scale is a clinical measure to assess the severity of spasticity
15780016|NCT04613635|Device|Stratafix|Closure of ventral defect of the otherwise stapled gastrojejunal anastomosis with Stratafix USP (United States Pharmacopoe) 2-0 thread
15780017|NCT04613635|Device|Vicryl|Closure of ventral defect of the otherwise stapled gastrojejunal anastomosis with Vicryl USP 2-0 thread
15780019|NCT04613609|Device|Electronic Cigarette containing nicotine|Non-smokers used an electronic cigarette containing nicotine
15780020|NCT04613609|Device|Electronic Cigarette without nicotine|Non-smokers used an electronic cigarette without nicotine
15780022|NCT04613583|Other|SAFeR fetuses|NO active intervention performed.
15780023|NCT04613570|Diagnostic Test|Upper gastrointestinal endoscopy|"In all patient's complete gastroscopy first with White light and then with virtual chromoendoscopy will be made;
~Suspicious lesions with dysplasia/cancer will be biopsied 1-2 fragments in a different vial; if an irregular area of mucosa (pattern C) with no clearly defined lesion then 1-2 guided biopsies fragments will be taken and sent in a different vial;
~EGGIM (Endoscopic Grading of Gastric Intestinal Metaplasia) will be calculated according to previous description of this classification:
~If EGGIM 0 (no endoscopically apparent IM) biopsies will be made in antrum, incisura and corpus according to Sydney-Houston protocol;
~If EGGIM 1 or more guided biopsies of suspicious areas of IM should be made replacing the random biopsies in that particular area;
~Antrum, incisura and corpus fragments should be sent in 3 separate vials;"
15780024|NCT04613557|Biological|CYAD-211|Allogeneic anti-BCMA chimeric antigen receptor (CAR) T-cell
15780025|NCT04613557|Drug|Endoxan|Preconditioning chemotherapy
15780026|NCT04613557|Drug|Fludara|Preconditioning chemotherapy
15780027|NCT04613544|Device|Voice Assist Arrhythmia Monitoring (VAAM)|application flag the potential occurrence of irregular heart rhythms suggestive of atrial fibrillation (AF) and notify to further investigate the occurrence of the suspected AF episode by prompting user to initiate ECG test to confirm.
15780028|NCT04613518|Drug|BMS-986165 Dose 1|Specified Dose on Specified Days
15780029|NCT04613518|Drug|BMS-986165 Dose 2|Specified Dose on Specified Days
15780030|NCT04613518|Other|Placebo Comparator|Specified Dose on Specified Days
15780031|NCT04613505|Behavioral|Semi-structured interview|Participants will be asked a set of questions as applicable to each phase. Researchers will be able to ask additional questions as they arise within each interview.
15780032|NCT04613505|Behavioral|Same day consent questionnaire|A questionnaire (yet to be developed) will be administered to participants.
15780033|NCT04613492|Biological|MEDI9253|Participants will receive either Single dose MEDI9253 or Multiple Dose MEDI9253; sequentially or concurrent with Durvalumab
15780034|NCT04613492|Biological|Durvalumab|Durvalumab treatment will be started sequentially or concurrently with MEDI9253
15780035|NCT04613453|Drug|Ketamine Infusion|Participants will receive four Ketamine infusions over two weeks, each 0.5mg/kg over 40 minutes.
15780036|NCT04613453|Drug|Midazolam Infusion|Participants will receive four Midazolam infusions over two weeks, each 0.045mg/kg over 40 minutes.
15780037|NCT04613440|Other|Family Letter (Standard of Care)|The family letter is given to probands in the standard of care arm and provides information on the familial mutation and serves to encourage first degree relatives to complete genetic testing.
15780038|NCT04613440|Other|Educational Video|The educational video is provided by the clinical genetic testing laboratory and explains the importance and implications of genetic testing. This educational video is shared with first degree relatives in the intervention arm
15780039|NCT04613440|Other|Mailed Saliva Kit for Genetic Testing|The FDR's email will be sent to the genetic testing lab, Invitae, which will allow them to log on to the online portal, create a unique account, and order a genetic testing saliva kit free of charge. The FDR will receive the kit and instructions in the mail. The FDR will collect the saliva sample and send the sample back to the genetic testing laboratory.
15780040|NCT04613440|Other|Telephone Counseling|The FDR's will be contacted and receive post genetic testing phone counseling
15780041|NCT04613414|Other|Early Management|Scheduled for sleep physician appointment within 1 month of home sleep apnea test/triage
15780042|NCT04613401|Other|questionnaire (observational study)|questionnaire about hospitalisation rates, complications (bleeding, infection, thrombosis), quality of life (Kansas-Score), depression (PHQ8)
15780043|NCT04613388|Other|Assesment of Effectiveness and side effects|Case Report forms, Quality of life questionaire
15780044|NCT04613375|Diagnostic Test|Urine sample collection|Serotype specific UAD (urinary antigen detection) test
15780045|NCT04613375|Diagnostic Test|Saliva collection|Streptococcus pneumonia identification in saliva samples by culture or PCR
15780046|NCT04613362|Behavioral|TENACITY Telehealth Cognitive Behavioral Therapy for Migraines|Clinical health psychology therapy delivered via telehealth
15780047|NCT04613362|Behavioral|Usual Care Outpatient Cognitive Behavioral Therapy for Migraines Face to Face|Clinical health psychology therapy delivered face to face at VA Medical Center outpatient clinic
15780048|NCT04613349|Other|MRI|"All patients included will benefit from the two methods of evaluating the anatomical relationships between the facial nerve and the parotid tumor:
~New medical imaging technique evaluated: high-resolution 3 Tesla parotid MRI with specific sequences and gadolinium injection;
~Gold standard: Intraoperative examination."
15780049|NCT04613310|Diagnostic Test|Rapid Diagnostic Test vs PCR|4 swabs taken, saliva for PCR and RDT, nasopharyngeal for PCR and RDT
15780050|NCT04613297|Other|Baseline and during hospitalization blood samples|"Blood sample will be performed at the inclusion visit for all patient and for the hospitalized COVID-19 infected patients, extra-blood samples will be performed :
~at day 3
~day 5 and
~In case of aggravation
~At the discharge from hospital"
15780051|NCT04613297|Other|Baseline blood sample|Blood sample will be performed at the inclusion visit only
15780081|NCT04613024|Drug|Gabapentin|Control group will be prescribed gabapentin after surgery with follow up at regular interval
15780082|NCT04613011|Device|Ultrasound|Checking vein width snd copression using US
15780052|NCT04613284|Drug|Recombinant human endostatin (Endostar)|Continuous intravenous infusion of endostar (Simcere Pharma- ceutical, Nanjing, China) was made over 120 h before the begin- ning of radiotherapy, and then repeated every two weeks. The dose was 7.5 mg/m2/24 h 120 h, 14 days/cycle. ECG monitoring was performed during the first delivery of endostar.
15780053|NCT04613284|Radiation|Thoracic irradiation of 50 Gy with 3DCRT or IMRT|Concurrent thoracic chemoradiotherapy with reduced irradiation dose of 50 Gy will be given to patients with unresectable stage III NSCLC who can not tolerate irradiation dose to 60 Gy.
15780054|NCT04613271|Drug|Favipiravir|"Assignment of Administration Group 1:
~Favipiravir 1600 mg twice a day at day 1 and 600 mg twice a day at day 7-14 + Azithromycin 500 mg once a day for 5 days."
15780055|NCT04613271|Drug|Azithromycin|Azithromycin 500 mg once a day for 5 days.
15780056|NCT04613258|Dietary Supplement|SCAR Porridge|The treatment group was given SCAR porridge supplementation in the form of a soft porridge (a mixture of 50 g dry powder porridge added to 200 mL of hot water) along with nutritional counseling. The control group only received nutritional counseling and no SCAR porridge supplementation. A 50 g portion of SCAR porridge was provided once a day for 14 days. The SCAR porridge was monitored and administered by a researcher once a week to inquire about adherence to the supplementation consumption and perceived side effects. All research subjects went through a clearance period of one week and were requested not to consume any supplements.
15780057|NCT04613258|Other|Counseling|21 subjects in the control group (C) who only received dietary counseling
15780058|NCT04613232|Device|Wearable sensor|The patients will be asked to wear an Apple Watch during their treatment course. The watch will pasively collect sensor data (heart rate and physical activity)
15780059|NCT04613219|Drug|Tofacitinib 5 MG [Xeljanz]|Treatment with Tofacitinib
15780060|NCT04613206|Biological|High Dose Quadrivalent Inactivated Influenza Vaccine|"Fluzone High-Dose (Influenza Vaccine) for intramuscular injection is an inactivated influenza vaccine, prepared from influenza viruses propagated in embryonated chicken eggs. The virus-containing allantoic fluid is harvested and inactivated with formaldehyde. Influenza virus is concentrated and purified in a linear sucrose density gradient solution using a continuous flow centrifuge. The virus is then chemically disrupted using a non-ionic surfactant, octylphenol ethoxylate (Triton® X-100), producing a split virus. The split virus is further purified and then suspended in sodium phosphatebuffered isotonic sodium chloride solution. The Fluzone High-Dose process uses an additional concentration factor after the ultrafiltration step in order to obtain a higher hemagglutinin (HA) antigen concentration."
15780061|NCT04613206|Biological|Standard Dose Quadrivalent Inactivated Influenza Vaccine|Fluzone ® Quadrivalent is a vaccine indicated for active immunization for the prevention of influenza disease caused by two influenza A subtype viruses and two type B viruses contained in the vaccine.
15780062|NCT04613193|Other|Blood presssure reduction|Patients will be uptitrated in antihypertensive treatment until the treatment target is achieved.
15780063|NCT04613180|Drug|Montelukast Sodium|Montelukast is used to prevent wheezing, difficulty breathing, chest tightness, and coughing caused by asthma in adults and children 12 months of age and older. Montelukast is also used to prevent bronchospasm (breathing difficulties) during exercise in adults and children 6 years of age and older.
15780064|NCT04613180|Drug|Placebo|placebo containing no active substance
15780065|NCT04613167|Drug|Alirocumab|The first group will receive alirocumab. Blood samples from all patients will be drawn for laboratory measurements and genetics determination. Ultrasound measurement of endothelium-dependent dilatation of the brachial artery, intima media thickness of carotid arteries and pulse wave will be measured.
15780066|NCT04613167|Drug|Evolocumab|The second group will receive evolocumab. Blood samples from all patients will be drawn for laboratory measurements and genetics determination. Ultrasound measurement of endothelium-dependent dilatation of the brachial artery, intima media thickness of carotid arteries and pulse wave will be measured.
15780067|NCT04613167|Drug|Control group|The third group will receive only optimal guidelines-based secondary preventive treatment. Blood samples from all patients will be drawn for laboratory measurements and genetics determination. Ultrasound measurement of endothelium-dependent dilatation of the brachial artery, intima media thickness of carotid arteries and pulse wave will be measured.
15780068|NCT04613154|Dietary Supplement|magnesiumcitrate|Magnesiumcitrate 250 mg, Apoteket AB, Sweden
15780069|NCT04613154|Dietary Supplement|Placebo|Ester-c
15780070|NCT04613141|Device|WalkingTall-PD|Smart garment (socks, insoles or ankle bands) delivering rhythmic haptic stimuli to the ankle timed with preferred cadence. Smart phone application delivers auditory cues synchronised with haptic stimuli. Smart phone application delivers a neurorehabilitation program.
15780071|NCT04613141|Other|Mobility-plus|Active 'pseudo placebo' comparator using a paper-based body weight exercise program.
15780072|NCT04613102|Drug|AVCN583601 (3% Cannabidiol cream)|Topical application twice daily for 4 weeks (phase 2) and for 8 weeks (phase 3).
15780074|NCT04613076|Behavioral|"Me cuido y me siento mejor"|A multicomponent, collaborative, computer-assisted, psycho-educational intervention for the management of depressive symptoms in primary care patients with diabetes and/or hypertension.
15780075|NCT04613076|Behavioral|Enhanced Usual Treatment|Enhanced Usual Treatment
15780076|NCT04613063|Other|Diagnostic laparoscopy|A diagnostic laparoscopy was performed where a dilated jejunum was encountered with impaction of fecal content. Surgery was converted to open surgery, where a longitudinal enterotomy of 5 cm after the transition zone was created, evacuating manually the fecal material with mucous secretion.
15780077|NCT04613050|Other|Respiratory Training|"Respiratory training in form of :
~Diaphragmatic breathing,Segmental breathing, Incentive spirometer:"
15780078|NCT04613050|Other|Aerobic training|aerobic exercises are customized according to the patient's underlying disease and residual dysfunction. These exercises will include walking on treadmill. After an initial, 5-minute warm-up phase performed on the treadmill at a low load, each endurance training session lasted 30 minutes and ended with 5-minute recovery and relaxation phase. A total of 3-5 sessions are carried out per week. Patients who are prone to fatigue should perform intermittent exercises
15780079|NCT04613037|Biological|Fecal Microbial Transplantation|Fecal Microbial Transplantation in adults with Atopic Dermatitis
15780080|NCT04613024|Drug|Topamax|Experiment randomized group will be prescribed Topamax before and after surgery with follow up at regular interval
15780083|NCT04612998|Other|left lateral decubitus position|Comparator group consisted of patients performing CSEA in the left lateral decubitus position.
15780084|NCT04612998|Other|sitting position|Active control group consisted of patients performing CSEA in the sitting position.
15780085|NCT04612998|Drug|The use of intravenous ephedrine.|Intravenous ephedrine (6 mg) was used to treat hypotension (a 30% decrease in systolic blood pressure compared to preoperative values) during surgery.
15780086|NCT04612998|Drug|The use of intravenous atropine.|Intravenous atropine (1 mg) was given in case of bradycardia (the heart rate < 45 beats/minute) during surgery.
15780087|NCT04612998|Drug|The use of intravenous metoclopramide|When nausea and vomiting were observed, intravenous metoclopramide (10 mg) was administered.
15780088|NCT04612985|Device|XACT Robotic System|CT-guided Minimally Invasive Procedures e.g., Biopsies
15780089|NCT04612972|Biological|Inactivated SARS CoV 2 vaccine (Vero cell) Wuhan/Beijing/Placebo|This clinical trial is conducted in randomized, blind, placebo controlled design Total sample size is 12 000, which are randomly allocated into investigational vaccine 1, investigational vaccine 2 and placebo control group.
15780090|NCT04612959|Other|Psychosexual care|The psychosexual caring program includes interventions to promote body awareness, the meaning of sexuality, and marital relationships by gaining communication skills, sexual communication, body knowledge, information about sexual health, and its dimensions.The psychosexual caring program includes psycho-education and sexual counseling.
15780091|NCT04612946|Behavioral|Referral to Telemedicine LCS Counseling Visit|Patients in the intervention arm will be invited to complete a telemedicine LCS counseling visit, and asked for permission to be referred directly to the LCS navigator to help schedule an appointment. They will also be given the option to directly contact the LCS navigator. Telemedicine counseling visits will be conducted using established clinical procedures for virtual or telephone visits at Penn Medicine. In accordance with reimbursement policies for lung cancer screening, these visits will be conducted by a physician or nurse practitioner within the Lung Cancer Screening Program at Penn Medicine. Counseling visits are covered without co-pay as standalone visits according to USPSTF guidelines and costs will not be covered by the study. LCS is an evidence-based practice and considered standard of care for those who are eligible and desire to be screened. Clinicians retain full control on how to conduct LCS counseling or LDCT in this trial.
15780092|NCT04612946|Behavioral|Usual Care|Patients in the usual care arm will be provided with contact information for the Penn LCS Program and encouraged to discuss LCS with their providers.
15780093|NCT04612933|Other|Intervention group video consultations|"All appointments, scheduled and non-scheduled are by telemedicine using video to commutate with the health care professionals.
~Patients will follow their usual treatment."
15780094|NCT04612920|Drug|Ibuprofen, acetaminophen, oxycodone|The timing of medications is the intervention.
15780095|NCT04612907|Radiation|Moderate hypo-fractionation|Patients will receive four weeks of radiotherapy
15780096|NCT04612907|Radiation|Ultra-hypo-fractionation|Patients will receive two and a half weeks of radiotherapy
15780097|NCT04612894|Drug|Camrelizumab and Apatinib|All patients will receive Camrelizumab and Apatinib for at least two cycles of neoadjuvant treatment
15780098|NCT04612894|Procedure|surgery|Perform surgery if operable after neoadjuvant therapy
15780099|NCT04612894|Procedure|core needle biopsy|Perform core needle biopsy if inoperable after neoadjuvant therapy
15780100|NCT04612881|Drug|fitostimoline vaginal pessaries|vaginal pessaries
15780101|NCT04612881|Other|standard of care|standard of care
15780102|NCT04612868|Device|AEYE Software Device|"Eligible participants will undergo the following procedures:
~Photographic imaging of each eye using a funduscopy camera device. Images obtained will be sent to the AEYE-DS software for analysis.
~Additional photographic and OCT images will be obtained using a second funduscopy/OCT camera device. Images obtained will be sent to a professional reading center for analysis.
~All study subjects will have their pupils dilated using dilation drops."
15780103|NCT04612855|Other|Groupwise comparison of primary and secondary outcomes|Statistical comparison of cohorts. Cfr supporting information on statistical plan.
15780104|NCT04612842|Behavioral|Motivational Interviewing|The PI and two study staff members (interventionists) will conduct study visits and phone calls. The same person will complete participant follow-ups to establish rapport and consistency. All of the study encounters will be audio recorded with participants' permission and study encounter notes will be completed by the interventionist. Interventionists will facilitate MI sessions using the MI guide and a participant handout. The goal of each MI session is to identify a specific fall prevention behavior, the participant's goal with this behavior, readiness to change, specific plan to move toward the goal, barriers and facilitators, and the participant's commitment level to change.
15780105|NCT04612829|Device|Medistus Antivirus Lozenges|A blend of Kistosyn Extract with Gum Arabic
15780106|NCT04612816|Other|Prehospital ultrasound|Feasibility of real time PEU transmission in a university affiliated preclinical emergency system.
15780107|NCT04612803|Drug|Antihistamine|Cetirizine 10 mg and famotidine 20 mg will be dispensed to each patient, to be taken twice a day at 6-9AM one hour before eating breakfast and again at evening 12 hours after the morning dose for 30 days
15780108|NCT04612790|Biological|Benralizumab|"Benralizumab subcutaneously (SC) loading dose followed by repeat dosing of SC benralizumab plus Oral Corticosteroids per SoC tapering.
~Open-Label (OLE): after completion of the double-blind treatment period, all participants will have the option of entering an OLE period, starting at week 36 benralizumab SC until study closure."
15780109|NCT04612790|Biological|Placebo|Placebo plus Oral Corticosteroids per SoC tapering. Open-Label (OLE): after completion of the double-blind treatment period, all participants will have the option of entering an OLE period, starting at week 36 benralizumab SC until study closure.
15780135|NCT04612634|Biological|Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang|Administration of one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Zhejiang. 0.5ml per dose.
15780136|NCT04612634|Biological|Hepatitis A (Live) Vaccine, Freeze-dried produced by the Institute of Medical Biology, CAMS|Administration of one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by the Institute of Medical Biology, Chinese Academy of Medical Sciences. 1.0ml per dose.
15780137|NCT04612621|Diagnostic Test|combination of diagnostic tests|capsule endoscopy, MRE , intestinal ultrasound, fecal microbiota, blood and serum biomarkers as described
15780138|NCT04612608|Procedure|upright bed|moving the bed into an upright position
15780110|NCT04612777|Behavioral|Opening Doors to Recovery|Opening Doors to Recovery (ODR) was created by a large, collaborative group in southeast Georgia as a recovery-oriented approach that navigates clients into services that may in some cases be fragmented and seemingly inaccessible. The team of three Community Navigation Specialists (CNSs) strives to help clients reduce institutional (e.g., hospital, jail) recidivism and embrace recovery. Their process of community navigation is a broader function than traditional case management as it includes mapping out and connecting clients to all available local resources, which requires being embedded in the community. The work of the CNSs benefits from commitments of diverse collaborative ODR partners, including local treatment providers, law enforcement, employers, and housing programs. Each CNS was expected to meet with the client at home or in community settings at least monthly, with the client having contact with at least one CNS weekly.
15780111|NCT04612777|Behavioral|Case Management|Case Management (CM) services, as defined by the State mental health agency, consist of providing essential environmental support and care coordination to assist the individual with improving his/her functioning, gaining access to necessary services, and creating an environment that promotes recovery as identified in his/her Individual Recovery Plan (IRP). The focus of interventions include assisting the individual with: (1) developing natural supports to promote community integration, (2) identifying service needs, (3) referring and linking to services and resources identified through the service planning process, (4) coordinating services identified on the IRP to maximize service integration and minimize service gaps, and (5) ensuring continued adequacy of the IRP to meet his/her ongoing and changing needs. Contact must be made with the individual ≥2 times per month, at least one of which must be in-person, in a non-clinic setting.
15780112|NCT04612777|Behavioral|Intensive Case Management|Intensive Case Management (ICM) is very similar to CM, but four in-person visits are required monthly. Additional contacts may be either face-to-face or via telephone, depending on the individual's needs. At least 60% of total contacts must be face-to-face with the individual, and at least 50% must be delivered in non-clinic/community-based settings. An ICM team includes nine professionals: a licensed clinician, four masters-level clinicians, two bachelors-level clinicians, and two paraprofessionals. The team's maximum case load is 200 in rural settings and 300 in urban settings (22-33 per team member).
15780117|NCT04612738|Behavioral|Hello (serious game)|Commercially available, 'Hello' 32 is a serious game that consists of 32 questions prompting players to share their values, goals, and beliefs about end-of-life issues. The creators developed the questions following interviews with palliative care clinicians, hospice nurses, and funeral directors, and then revised them through a series focus groups with >100 patients/caregivers from diverse backgrounds.
15780118|NCT04612738|Behavioral|The Conversation Project (CP) Starter Kit|"The CP Starter Kit is one of the most widely promoted and disseminated ACP tools nationwide, is available for free online, and does not require a healthcare professional for use. Like 'Hello', it is intended to help individuals have end-of-life conversations with loved ones. The 11-page workbook has open- ended prompts to consider one's values and preferences for end-of-life care, who to talk with about one's wishes, and suggestions on how to do so. It also prompts participants to rank priorities on a 5-point scale (e.g., What are your concerns about treatment? 1= I'm worried I won't get enough care, 5= I'm worried I'll get overly aggressive care). The CP website provides resources for running a community event using the 'CP Starter Kit', including a 23-page manual, Coaching the Conversation- A Guide to Facilitating Conversation Groups, with details on hosting a community-based program."
15780119|NCT04612738|Other|Table Topics (general conversation game)|Table topics is a popular, commercially available conversation starter game that consists of question cards to prompt conversations (e.g., 'What do you love about your hometown?').
15780120|NCT04612725|Biological|Benralizumab|2 induction doses of benralizumab (dose A and B) compared to placebo, and a comparison of maintenance dosing regimens (B vs A) in the 28-week extension period.
15780121|NCT04612725|Biological|Placebo and Benralizumab|2 induction doses of benralizumab (dose A and B) compared to placebo, and a comparison of maintenance dosing regimens (B vs A) in the 28-week extension period.
15780122|NCT04612712|Drug|Donafenib Tosilate Tablets|In the dose exploration phase (phase I) : three doses of Donafenib tosylate tablets [50 mg twice a day; 100 mg twice a day; 200 mg twice a day ] will be explored. In the dose expansion phase (phase II), patients with advanced hepatocellular carcinoma will be treated at the recommended dose for phase 2(RP2D).The RP2D will be determined by the dose escalation study.
15780123|NCT04612712|Biological|KN046 Injection|5mg/kg Q3W
15780124|NCT04612699|Drug|Jaktinib|Administered orally
15780125|NCT04612699|Drug|Placebo|Administered orally
15780126|NCT04612673|Drug|Sintilimab|immune checkpoint inhibitor, 200mg, iv, d1,Q3W
15780127|NCT04612660|Behavioral|Education on cervical cancer prevetnion|Motivational group education by trained bilingual community health educators (CHEs) on cervical cancer prevention
15780128|NCT04612660|Behavioral|Dynamic group interaction|Dynamic group interaction and role play discussion sessions on the benefits of Self-Sample collection HPV testing and procedures;
15780129|NCT04612660|Behavioral|Physician engagement|Engaging community bilingual physicians in cervical cancer screening and referral;
15780130|NCT04612660|Behavioral|Patient Navigation|Patient navigation assistance will be provided to participants who tested HPV positive for further diagnostic testing and treatment.
15780131|NCT04612660|Behavioral|General Health Education|general health education focusing on healthy lifestyle, and prevention of disease through routine health examinations.
15780132|NCT04612647|Other|12-week FMS Intervention|4 sessions, no more than 3 hours per session covering 1) Sensory Integration, 2) Communication, 3) Aquatic Opportunities, and 4) Physical activity and Sports (during intervention)
15780133|NCT04612647|Behavioral|Physical Activities & Activity Booklets|expected to engage in physical activity at least 3 hours per week
15780134|NCT04612634|Biological|Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun|Administration of one dose of Hepatitis A (Live) Vaccine, Freeze-dried produced by Changchun. 0.5ml per dose
15780139|NCT04612595|Other|serum urea nitrogen to creatinine ratio|According to sex and CKD stage , patients are divided into four groups,then evaluate whether the different mean sUCR and ΔsUCR can influent the survival of DKD patients.
15780140|NCT04612582|Drug|Thalidomide|Bortezomib (d 1, 8, 15, 22, 1.3mg /m2, subcutaneous injection); thalidomide (d 1-28 50-100mg, oral); dexamethason (d 1, 2, 8, 9, 15, 16, 22, 23, 20mg, oral/intravenous injection) as a course of treatment, the patients will complete six courses of treatment after entering the group, and the total observation time is one year after the end of treatment.
15780141|NCT04612582|Drug|Cyclophosphamide|Bortezomib (d 1, 8, 15, 22,1.3mg / m2, subcutaneous injection); cyclophosphamide (d 1, 2,900mg / m2, intravenous drip); dexamethason (d 1, 2, 8, 9,15, 16, 22, 23, 20mg, oral/intravenous injection) as a course of treatment, patients will complete six courses of treatment after entering the group, the overall observation time is one year after the end of treatment.
15780142|NCT04612556|Drug|Mepolizumab 100 MG [Nucala]|subcutaneous injection once a month
15780143|NCT04612543|Device|Genial Posterior Composite with Polyethylene Fiber|Placing restorations,Genial Posterior Composite with Polyethylene Fiber, after bonding procedures, remaining tooth composite resin walls were created and cured for 20 s. Prepared ribbond fiber pieces, 2-mm-wide approximately 12mm-long, (Ribbond Thinner, Higher, Modulus, Ribbond Inc,Seattle) were wetted with an unfilled resin for 2 minutes at a non-light environment. The inner surfaces of the prepared class I cavity were lined with flowable resin. After removing the excess resin, pre-wetted polyethylene fiber was condensed circumferentially and embedded with a hand instrument into the bed of unpolymerized flowable composite and then polymerized for 20 seconds with Light Emitting Diodes. After curing for 20 s, composite resin was applied to the rest of the cavity incrementally, each increment was cured for 20 seconds. Finally, the restoration was shaped with finishing diamonds and silicon instruments.
15780144|NCT04612543|Device|Genial Posterior Composite|Placing Genial Posterior Composite, the enamel and dentin were conditioned with bonding procedure using an applicator, left undisturbed for five to 10 seconds, and then dried thoroughly for five seconds with oil-free air under air pressure, Genial Direct Posterior resin was applied with the incremental technique (2 mm thick layers) and light-cured for 20 seconds. Finally, the restoration was shaped with finishing diamonds and silicon instruments
15780145|NCT04612530|Device|Irreversible Electroporation (IRE)|Irreversible electroporation (IRE) is a local ablative technique that utilizes electrical pulses to destroy tumor tissue
15780146|NCT04612530|Drug|Nivolumab|Nivolumab is an immune checkpoint inhibitor targeting the PD-1 receptor on T-cells. Binding of the PD-1 monoclonal antibody onto the PD-1 receptor blocks the brake signal on the T-cells, allowing them to attack the cancer cells.
15780147|NCT04612530|Drug|Toll-Like Receptor 9|Toll-Like Receptor 9 (CpG) is an oligodeoxynucleotide that stimulates dendritic cells to release IFN type I, activating natural killer and infiltrating T cells. This creates a more pro-immunogenic tumor environment.
15780148|NCT04612517|Drug|ZP7570|Each subject will be randomly allocated to multiple doses of ZP7570 at one of four dose levels in each cohort.
15780149|NCT04612517|Drug|Placebo|Placebo; corresponding volume
15780150|NCT04612504|Biological|SynOV1.1|IT
15780151|NCT04612504|Drug|Atezolizumab|IV
15780152|NCT04612491|Behavioral|Pre-operative Consultation|Pre-operative consultation will be given before Mohs surgery
15780153|NCT04612478|Behavioral|Self-Directed Exercise Program|The full SDEP program, which will be developed by physical therapists, orthopaedic trauma surgeons, and investigators with experience in health behavior change, will be designed to maximize adherence/compliance with the program
15780154|NCT04612478|Behavioral|Clinic-Based Physical|Patients will be referred to PT by the orthopaedic surgeon for enrollment into a clinic-based PT program per usual referral patterns at the surgeon's center. Patients will receive services based on their health care benefits defined by his or her insurance plan.
15780155|NCT04612465|Biological|ASC|"Injection of ASC(Autologous Adipose-derived Mesenchymal Stem Cells) to Crohn's Fistula.
~The ASC injection dose is about 1x10^7 cells of ASC per 1cm^2 of the surface area of the fistula, and the additional injection dose is 1.5 times the initial injection dose. and up to 30% of the ASC injection dose is administered in combination with Fibringlu."
15780156|NCT04612465|Drug|Fibringlue|Injection of Fibringlue to Crohn's Fistula. The Fibringlu injection dose is given the size of the fistula that is fill the entire fistula, and the additional injection dose is the same.
15780157|NCT04612439|Device|VABB Elite 10G|If the biopsy device is a vacuum-assisted Elite 10G needle, insert the needle groove into the mass and rotate to cut the biopsy tissue one circle
15780158|NCT04612439|Device|BARD 14G CNB|If the biopsy device is a BARD 14G hollow core needle, insert the needle to the edge of the mass and pull the trigger in different directions to eject the needle to retrieve the material
15780159|NCT04612426|Device|Brain-computer Interface-Pedaling Training System|The Brain-computer Interface-Pedaling Training System includes four parts: computer, monitor, EEG testing equipment and pedaling training equipment. The patient wears an EEG detection device, which calculates brain movement participation every 0.5 seconds. The system will provide real-time visual/auditory/somatosensory feedback to patients based on the results of participation, so that patients can participate in motor function training more attentively.
15780160|NCT04612426|Device|Traditional Pedaling Training System|The patient will wear the same EEG equipment that will only collect data, but not guide training.
15780161|NCT04612413|Drug|ALLOCETRA-OTS|The product contains allogeneic donor mononuclear enriched cells in the form of a liquid suspension containing early apoptotic cells.
15780162|NCT04612413|Other|Placebo|Ringer's Lactate Solution
15780164|NCT04612387|Behavioral|Mind-body therapy|Online yoga, meditation and nutrition tips.
15780165|NCT04612374|Behavioral|Unified Protocol for Transdiagnostic Treatment of Emotional Disorders|Please see arm/group descriptions
15780166|NCT04612374|Behavioral|Revised Unified Protocol for Transdiagnostic Treatment of Emotional Disorders|Please see arm/group descriptions
15780167|NCT04612361|Other|insommnia severity index questionnaire|insomnia severity index questionnaire and scoring system
15780168|NCT04612348|Diagnostic Test|Ultrasound|Point of care ultrasound to measure gastric contents.
15780661|NCT04608305|Biological|IIBR-100 high-dose (prime)|Single administration of IIBR-100 1*10E7 pfu/ml
15780169|NCT04612335|Other|Rate control|Rate control drugs are administered to obtain symptom relief and a heart rate of <110 bpm, followed by a 4-week telemonitoring period.
15780170|NCT04612335|Other|Pharmacological or electrical cardioversion|Pharmacological or electrical cardioversion is performed to achieve restoration of sinus rhythm, either acutely or in a wait-and-see approach, all within 48 hours, and followed by a 4-week telemonitoring period.
15780171|NCT04612322|Device|Assessment of microvascular function with intracoronary hemodilution|The pressure/temperature wire allows assessing coronary flow reserve, intracoronary pressure, and coronary flow to calculate multiple parameters of coronary macro- and microvascular function.
15780172|NCT04612309|Drug|Immunotherapy|patient treated with at least 1 immunotherapy administration
15780173|NCT04612296|Genetic|Research genetic analysis|Genetic analysis of DNA extracted from saliva. Participants can opt in to receive individual results of research genetic analysis for a predefined panel of clinically actionable cardiomyopathy genes.
15780174|NCT04612283|Other|NGA-01 gel|NGA-01 is a gel formulation with mostly herbal active ingredients
15780175|NCT04612283|Other|Placebo|A Placebo with no active ingredients
15780176|NCT04612270|Other|Venous blood collection|Two venous blood collections in within one week. No drug-related intervention in-vivo.
15780177|NCT04612257|Other|Insulin-alone closed-loop|40-hour intervention period using the insulin-alone closed-loop system.
15780180|NCT04612231|Behavioral|TEACCH School Transition to Employment and Postsecondary Education (T-STEP)|The T-STEP Program is a 12-week transition intervention targeting specific challenges that young adults with ASD experience in executive function, social communication, and emotion regulation including group intervention, internship, and counseling services
15780181|NCT04612231|Behavioral|Counseling Services Alone|The Counseling Services Alone Intervention will receive 12 hours of individual counseling focused on job exploration/career counseling, academic counseling, and self-advocacy counseling.
15780182|NCT04612205|Device|TECAR followed by pelvic floor exercises|The signal generator was an INDIBA® 448 kHz RF device (vagina/rectum) (INDIBA SA, Barcelona, Spain).
15780183|NCT04612205|Other|pelvic floor exercises|The patients will instructed to contract their pelvic floor muscles without contracting adjacent muscles, such as the abdomen, glutei and hip adductors muscles twenty repletion consisted of contraction and squeezing of the muscle ten seconds followed by relaxation for twenty second then rested for two minutes. The exercises program lasted for lasting 45 min. divided into 5 min. warming up, 35 min. actual treatment and 5 min. cooling down, three times a week for eight consecutive weeks. The patient will teach to contract their pelvic floor muscles before coughing or sneezing thus to prevent leakage. Home exercises through continuing practicing these contractions as frequent as possible according to her ability, at early morning before getting from bed from crock lying position, at afternoon from sitting and standing positions, at evening from sitting and standing positions and finally at night at bed time from crock lying position.
15780184|NCT04612192|Device|Active luminette|receive an active blue-enriched light-glasses of 1500 lux (an average of 180 photons/s/cm2, with a maximum wavelenght at 468 nm), 30-minute long light therapy in the morning, in a time period defined by sleep log and chronotype questionnaire, on a 4-week period
15780185|NCT04612192|Device|Placebo luminette|receive a dim red-light placebo light (an average of n photons/s/cm2, single- band spectrum with a narrow peak at 660 nm under 50 lux), with the same modality as the experimental group
15780186|NCT04612179|Device|The SUPRAFLEX CRUZ™ Sirolimus eluting coronary stent system|"Investigational device: SUPRAFLEX CRUZ™ Sirolimus eluting Coronary Stent System The SUPRAFLEX CRUZ™ Sirolimus eluting coronary stent system consists of a balloon ex-pandable Sirolimus eluting stent, premounted on a stent delivery system. The active pharmaceutical ingredient in the SUPRAFLEX CRUZ™ Sirolimus eluting coronary stent is Sirolimus (also known as Rapamycin).
~The SUPRAFLEX CRUZ™ Sirolimus eluting coronary stent system is indicated for improving coronary luminal diameter in patients with symptomatic Ischemic heart disease due to discrete de-novo stenotic lesions and in-stent restenotic lesions in native coronary arter-ies with a reference vessel diameter of 2.00 mm to 4.50 mm."
15780187|NCT04612166|Behavioral|Medication Action Plan and Patient Empowerment (MAP-PE )|Intervention patients (after consenting) will meet with a study health coach for an in-person meeting where the health coach will review the pharmacists Medication Action Plan (MAP) for deprescription of high-risk medication. The MAP will have previously been approved by both the patient and the patient's primary care physician. If the patient is on more than one high risk medication, the medication that puts them at the highest risk will be deprescribed first and only one medication will be decreased at a time. During this initial meeting, the health coach will use motivational interviewing and distribute materials to empower and support the patient in the reduction of the medication as outlined on their MAP. The health coach will then follow up with the patient on a schedule determined by the type and dosage of medication being reduced. Follow ups will decrease in frequency over time (starting with at least once a week). The patients will be followed for 24 months.
15780188|NCT04612153|Other|Epidemiologic|Epidemiologic study. Observational, transverse study
15780189|NCT04612140|Procedure|Radiosurgery|The study subjects randomized in this study arm will undergo a radiosurgery procedure.
15780190|NCT04612140|Procedure|Repeated catheter ablation|The study subjects randomized in this study arm will undergo repeated catheter ablation.
15780191|NCT04612127|Dietary Supplement|Dietary supplement consumption and physical exercise|"The consumption time of the experimental product was 90 days and the control consumption time was 90 days.
~During this time, training should be done three times a week."
15780192|NCT04612114|Diagnostic Test|Belun Ring|Simultaneous recording of Belun Ring data (pulse oximeter, pulse rate and actigraphy) and standard of care PSG will be performed for one night.
15780224|NCT04611776|Drug|Atezolizumab|Atezolizumab will be administered intravenously during the induction phase and the maintenance phase.
15780225|NCT04611776|Drug|Placebo|Placebo will be administered intravenously during the induction phase and the maintenance phase.
15780226|NCT04611776|Drug|Carboplatin|Carboplatin will be administered intravenously during the induction phase.
15780227|NCT04611776|Drug|Cisplatin|Cisplatin will be administered intravenously during the induction phase.
15780193|NCT04612088|Behavioral|Cognitive Dissonance|"A blood sample will be taken before the first take of the multivitamins and at the end of the intervention to measure: Hemoglobin, Calcium, Phosphorous, Iron, Copper, Zinc, Vitamin D, and Folate.
~During the three months of the intervention, the intervention group will receive one psycho-educative session and five Cognitive Dissonance sessions.
~Several tests will be applied to the patients at the beginning of the program and after the sessions to measure: patient knowledge and adherence to the multivitamin, self-efficacy, self-care, and Psycho-pathological symptoms.
~The No intervention group on the wait list will receive the five Cognitive Dissonance sessions after the three months of the study."
15780194|NCT04612075|Diagnostic Test|FDG-PET/MRI|Performed at baseline, interim and at 12-16 weeks post radiotherapy.
15780195|NCT04612062|Drug|CEE321|CEE321 administered to all subjects
15780196|NCT04612049|Other|Immersive virtual reality visuo-motor skill assessment|Visuo-motor skill assessment in an immersive 3D virtual environment using a head-mounted display.
15780197|NCT04612036|Device|Journey II Bi-Cruciate Stabilized TKA|Total Knee Arthroplasty System
15780198|NCT04612036|Device|Journey II Cruciate Retaining TKA|Total Knee Arthroplasty System
15780199|NCT04612036|Device|Journey II Bi-Cruciate Retaining TKA|Total Knee Arthroplasty System
15780200|NCT04612023|Other|Acellular Amniotic Membrane Derived Allograft Injection (NuDYN)|Injectable acellular amniotic membrane derived allograft tissue (NuDYN) through routine follow-up with physical examination, pain, function and quality of life measurements and compare dose effects (1 mL versus 2 mL of NuDYN injection) to a placebo (sterile saline) in the treatment of knee osteoarthritis. Injection is minimally invasive and is FDA regulated (HCT/P regulation).
15780201|NCT04612010|Device|WAVES (Wobble-oscillator Auditory/Visual Excitatory Stimulation)|An app-based stimulation program administered that provides desynchronizing visual and auditory stimulation. The frequency of the stimulation oscillates around the baseline frequency determined by EEG.
15780202|NCT04611997|Procedure|Indocyanine Green Tracer Using in Laparoscopic Gastrectomy|Indocyanine Green Tracer Using in Laparoscopic Gastrectomy with Lymph Node Dissection for Locally Advanced Gastric Cancer After Neoadjuvant
15780203|NCT04611984|Procedure|Piezocision|Piezocisions were performed on the mesial and distal sides of the right maxillary canines. Then canine distalization was performed via closed-coil springs applying 150 g of force by using mini-screws as anchorage.
15780204|NCT04611984|Procedure|Control|The mesial and distal sides of the left maxillary canines served as controls and canine distalization was performed via closed-coil springs applying 150 g of force by using mini-screws as anchorage.
15780205|NCT04611971|Drug|Benlysta|Benlysta injection will be administered subcutaneously.
15780206|NCT04611971|Drug|Candin|Candin will be administered intradermally along with NaCl solution.
15780207|NCT04611958|Drug|ERCP with Bupivacaine infusion|"Selective cannulation of the pancreatic duct with ERCP scope will be performed. Any contrast dye used will be carefully aspirated and the duct will be flushed with saline as necessary to clear all residual dye. The canula will be taken to the tail of the pancreatic duct, and gradually withdrawn with slow infusion of the bupivacaine solution. Liposomal bupivacaine (13.3 mg/ml of Exparel) will be injected into the main pancreatic duct for a total of 5-10 ml (depending on the length of the pancreatic duct).
~Immediately after the procedure, the patient will be monitored for any evidence of acute pancreatitis (worsening abdominal pain, with amylase or lipase x3 upper limit of normal). The patient will be questioned daily after the procedure for common side effects of bupivacaine including nausea, fever, change in taste, dizziness, weakness, palpitations and loss of taste or any other new or unusual symptom."
15780208|NCT04611932|Drug|CKD-330 Tab. and D090 Tab.|1T
15780209|NCT04611932|Drug|CKD-333 Tab.|1T
15780210|NCT04611880|Drug|Crizanlizumab|Drug: crizanlizumab is a humanized monoclonal anti-P-selectin antibody that prevents leukocyte adhesion to the vascular endothelium, thereby limiting risk of microvascular occlusion. It is administered intravenously.
15780211|NCT04611867|Other|Supportive application with integrated weekly PRO|Patients will fill in a web-based application PRO-CTCAE with integrated preparation questionnaire every week. If their weekly reported symptoms exceed a predefined threshold of severity, this results in a notification on the staff application interface and a nurse will contact a patient for verification of symptoms. Nurse will review patient recent treatment and PRO reports and advise patient according to the local practice for symptom management and reinforce reporting. Nurse will consult with or refers to (if possible) treating physician if patient will require medical intervention and/or physician assistance.
15780212|NCT04611854|Behavioral|Guidance|Guidance from a health educator through regular weekly online messages. Participants may also be contacted through emails and phone calls. The team of guides consists of registered social workers, psychologists, and graduate students, with experience delivering ICBT.
15780213|NCT04611854|Behavioral|ICBT for alcohol misuse|The 8-week internet-delivered cognitive behaviour therapy (ICBT) course for alcohol misuse. The course consists of 8 lessons distributed across 8 weeks.
15780214|NCT04611828|Device|Philips SmartSleep|closed-loop auditory stimulation
15780215|NCT04611815|Procedure|Total knee arthroplasty|Participant will undergo robotic-assisted or conventional total knee arthroplasty
15780216|NCT04611815|Diagnostic Test|Conputer tomography scan|CT scans of the affected knee joint before and after the surgical procedure
15780217|NCT04611815|Diagnostic Test|biomechanical assesment|Participants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively
15780218|NCT04611802|Biological|SARS-CoV-2 rS/Matrix-M1 Adjuvant (Initial Vaccination Period)|Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS co-formulated with Matrix-M1 adjuvant (0.5 mL) on Days 0 and 21 in Initial Vaccination Period.
15780219|NCT04611802|Other|Placebo (Initial Vaccination Period)|Alternating intramuscular (deltoid) injections of placebo (0.5 mL) on Days 0 and 21 in Initial Vaccination Period.
15780220|NCT04611802|Biological|SARS-CoV-2 rS/Matrix-M1 Adjuvant (Crossover Vaccination period)|In Crossover Vaccination period, one dose of intramuscular (deltoid) injection of SARS-CoV-2 rS co-formulated with Matrix-M1 adjuvant (0.5 mL) on Day 0 or Day 21
15780221|NCT04611802|Other|Placebo (Crossover Vaccination period)|In Crossover Vaccination period, one dose of intramuscular (deltoid) injection of placebo (0.5 mL) on Day 0 or Day 21
15780222|NCT04611789|Drug|LY3832479|LY3832479 administered SC.
15780223|NCT04611789|Drug|Placebo|Placebo administered SC.
15780741|NCT04607772|Drug|Oxaliplatin|Dose: 100 mg/m^2
15780228|NCT04611776|Drug|Pemetrexed|Pemetrexed will be administered intravenously during the induction phase.
15780229|NCT04611776|Drug|Gemcitabine|Gemcitabine will be administered intravenously during the induction phase.
15780230|NCT04611776|Drug|Paclitaxel|Paclitaxel will be administered intravenously during the induction phase.
15780231|NCT04611763|Drug|Flurbiprofen axetil preoperatively|give Flurbiprofen axetil 15 min before surgery
15780232|NCT04611763|Drug|Flurbiprofen axetil postoperatively|give Flurbiprofen axetil at the end of surgery
15780233|NCT04611750|Drug|AD036|AD036 will be given for 14 days
15780234|NCT04611750|Drug|Placebo|Placebo will be given for 14 days
15780235|NCT04611737|Behavioral|Interviewing|Self-Determination Theory within motivational interviewing
15780236|NCT04611724|Drug|FOLFIRINOX|oxaliplatin 85 mg/m2 IV over 2 hours leucovorin 400 mg/m2 over 2 hours irinotecan 150 mg/m2 over 90 min, 5-FU continuous infusion 2400 mg/m2 continuous infusion over 46 hours
15780237|NCT04611711|Drug|decitabine＋ TQB2450 injection|"Real low-dose epigenetics drugs (decitabine) can reverse the resistance of PD-1 inhibitors by re-regulating the immune microenvironment.
~TQB2450 is a humanized monoclonal antibody targeting PD-L1, which prevents PD-L1 from binding to the PD-1 and B7.1 receptors on the surface of T cells, so as to restore the activity of T cells and thereby enhance the immune response, and has the potential to treat various types of tumors."
15780238|NCT04611711|Drug|decitabine＋ TQB2450 injection＋Anlotinib|"Real low-dose epigenetics drugs (decitabine) can reverse the resistance of PD-1 inhibitors by re-regulating the immune microenvironment.
~TQB2450 is a humanized monoclonal antibody targeting PD-L1, which prevents PD-L1 from binding to the PD-1 and B7.1 receptors on the surface of T cells, so as to restore the activity of T cells and thereby enhance the immune response, and has the potential to treat various types of tumors.
~Anlotinib Hydrochloride is a multi-target receptor tyrosine kinase inhibitor with significant inhibitory activity against angiogenesis related kinases (VEGFR1/2/3, FGFR1/2/3, etc.) and other tumor cell proliferation-related kinases (PDGFR /, C-Kit, RET, etc.), which can play a dual role in anti-tumor angiogenesis and tumor growth inhibition. "
15780239|NCT04611698|Device|Baha sound processor BA400|Baha sound processor BA400 is a cochlear implant designed specifically for soft tissue preservation.
15780240|NCT04611685|Drug|NSAID|Immediately after the operation, the patient is given (parecoxib 40 mg + sodium chloride 100 ml) intravenously once, and then given (loxoprofen 60 mg) orally twice a day during the first three postoperative days.
15780241|NCT04611685|Drug|Tramadol|Immediately after the operation, the patient is given (tramadol 100 mg) intramuscularly once, and then given (tramcontin 100 mg) orally twice a day during the first three postoperative days.
15780242|NCT04611672|Diagnostic Test|Assessment of CA|As part of our routine stroke work up, each patient receives an initial CT scan with CT perfusion to indicate thrombolysis therapy (intravenous, mechanical, or both, depending on the time since first stroke symptoms and perfusion-mismatch), an MRI within 2 days, extracranial and transcranial Duplex ultrasound, echocardiography, continuous Monitoring of BP, O2, body temperature, NIHSS and Glagow Coma Scale (GCS) every 6 hours. Assessing CA by continuous recording of blood pressure, cerebral blood flow velocity, end-tidal CO2. Analysis via Transfer function estimates
15780243|NCT04611672|Diagnostic Test|Assesment of CA only|Assessing CA by continuous recording of blood pressure, cerebral blood flow velocity, end-tidal CO2. Analysis via Transfer function estimates
15780244|NCT04611659|Behavioral|Motivational Interviewing and Educational Training (MIET)|Women in the intervention arm will receive a motivational interviewing intervention coupled with education on contraception and the potential for neonatal abstinence syndrome.
15780245|NCT04611646|Behavioral|Heat-suit endurance training|Participants (elite cyclists) will conduct five 50-minute low-intensity cycling sessions with heat suit per week for five weeks. These sessions will complement their habitual training routines, which will consist of endurance training with intensities at or below lactate threshold. Participants will ingest 100 mg Fe2+ on a daily basis to support de novo synthesis of hemoglobin
15780246|NCT04611646|Behavioral|Non-heat-suit endurance training|Participants (elite cyclists) will conduct low-intensity cycling without heat suit for five weeks (volume- and intensity-matched to the heat-suit arm). Participants will ingest 100 mg Fe2+ on a daily basis to support de novo synthesis of hemoglobin
15780247|NCT04611633|Combination Product|Trimbow|As this is a non-interventional study, all treatment decisions will be made at the discretion of the treating physician prior to enrolment in the study and during the entire period of the study. Treatment will be prescribed according to the product label in the summary of product characteristics.
15780248|NCT04611620|Behavioral|Cognitive Dysfunction|To fully characterize factors associated with cognitive dysfunction in BCS and CRC survivors that have cognitive concerns and (2) to fully characterize factors associated with psychoneurological symptom cluster in BCS and CRC survivors.
15780249|NCT04611594|Behavioral|Fluid restriction|Ingestion of approximately 20 ml / kg of ideal weight,
15780250|NCT04611568|Other|Educational Intervention|Receive educational and training material
15780251|NCT04611568|Other|Educational Intervention|Receive educational lecture
15780252|NCT04611568|Behavioral|Health Education|Receive melanoma curriculum
15780253|NCT04611568|Behavioral|Media Campaign|View digital media strategies
15780254|NCT04611568|Other|Survey Administration|Complete survey
15780255|NCT04611542|Behavioral|Fathering In Recovery|Fathering In Recovery (FIR) will be designed to address the unique needs of fathers in treatment for opioid misuse. FIR integrates evidence-based parenting interventions that have well-documented positive outcomes on children, parents, and families, with innovative web-based mobile technology to maximize accessibility, fidelity, and consistency of intervention and support.
15780256|NCT04611529|Drug|Ibuprofen 400 mg|Ibuprofen 400mg
15780257|NCT04611529|Drug|Topical diclofenac|Diclofenac 1% gel 4gm
15780284|NCT04611256|Drug|Control|Conventional treatment that may include analgesic, anti-inflammatory, antibiotic, steroid, antiplatelet, and anticoagulant.
15780285|NCT04611243|Biological|third dose vaccination with CoronaVac vaccine|Healthy individuals with low antibody levels after 2 doses of CoronaVac vaccine to receive one additional dose of CoronaVac vaccine
15780286|NCT04611243|Biological|third dose vaccination with BionTech vaccine|Healthy individuals with low antibody levels after 2 doses of CoronaVac vaccine to receive one additional dose of BionTech vaccine
15780742|NCT04607759|Dietary Supplement|nutraceutical|Subjects will consume two capsules for eight weeks
15780258|NCT04611503|Drug|subretinal injection of rAAV.hPDE6A|"The first 3 patients (C1) will receive the intermediate dose 1x1010 vg. After injection of the 3rd patient of C1, the DMC will give a go/no go decision. If 'nogo', a lower dose (5x109 vg) will be given to the next group of 3 patients (C2). The DMC will give a go/no go decision. In case of a go decision, 3 further patients (C3) will be treated with the same dose. In the case of a no-go decision, the next dose will be the minimal dose 1x109 vg. In case of a 'go' decision of the DMC after the third patient, the next 3 patients will receive a subretinal injection of vector at the highest dose 5x1010 vg. The DMC will give a go/no go decision after review of all safety data available at D30 of cohort 2. If safety data is considered favourably by the DMC, then 3further patients (cohort 3) will be treated with the same dose (5x1010 vg). Should any safety concerns arise, the last three patients (cohort 3) will receive the intermediate dose (1x1010 vg)."
15780259|NCT04611490|Procedure|Spine Fusion|Each patient will undergo a spine fusion for a evolutive idiopathic scoliosis with the help of the surgivisio system.
15780260|NCT04611477|Other|Rice Hulk|Placebo
15780261|NCT04611477|Other|Synbiotic365 Ver 5|Active Comparator
15780262|NCT04611477|Other|Synbiotic365 Ver 7|Active Comparator
15780263|NCT04611464|Drug|Misoprostol|Misoprostol is a PGE1 analog
15780264|NCT04611451|Other|classic lumbar home exercise|classic lumbar home exercise
15780265|NCT04611451|Device|Whole body vibration|Whole body vibration (WBV), which is a new treatment method and applied through the device, is defined as mechanical repetitive motion or oscillatory motion occurring around a balance point
15780266|NCT04611451|Other|Whole body vibration exercise|Whole body vibration exercise
15780267|NCT04611438|Drug|Cannabidiol|"Intervention schedule for each patient is as follows:
~Baseline Phase (2 weeks) Baseline Phase starts from the screening visit, where the patient and caregiver write permission to the trial and goes through laboratory, electroencephalography, and neuropsychological tests.
~Treatment Period: Titration (2 weeks) + stabilization period (10 weeks) + maintenance period (12 weeks)
~Titration: The patient would start cannabidiol on 5mg/kg/mg for 1 week and titrate dosage up to 10mg/kg/day for second week with the caregiver monitoring the patient's tolerability
~Stabilization: caregiver monitoring the patient's tolerability, with no change in medication dosage
~Maintenance: no change in medication dosage"
15780268|NCT04611425|Drug|Remimazolam|Patients will receive an infusion of Remimazolam for a maximum duration of 48 hours. The dose of Remimazolam will be adapted according to the ICU units protocol of analgesia-sedation management, based on validated scale (Richmond Assessment Sedation Scale). Owing to previous data gathered through a previous study in Japan, the initial dose of infusion will be within a 0.2-0.5 mg/min range. The dose of Remimazolam can be increased or decreased by 0.1mg/min when needed. The maximum dose of Remimazolam will be set at 1 mg/min.
15780269|NCT04611412|Other|Risk Factors|BMI in children and adolescents was compared with percentile charts developed by who for children from 5 to 19 years of age (WHO Growth Reference, 2007). Body mass index was defined as the ratio of body weight (in kg) to body length in the supine position or height in the standing position (m2).
15780270|NCT04611399|Behavioral|VR for psychoeducation and relaxation|"Use of specifically developed VR contents to deliver psychoeducational content on stress and anxiety (i.e., MIND-VR) and to train on relaxation techniques (i.e., The Secret Garden)."
15780271|NCT04611399|Behavioral|Text material for psychoeducation and audio for relaxation techniques|Use of non-immersive contents to deliver psychoeducation on stress and anxiety (i.e., a PowerPoint presentation containing the same words and images in static form on a desktop of virtual psychoeducational content), and to train on relaxation techniques (i.e.,watching a video for relaxation)
15780272|NCT04611386|Drug|computerized tomography|Anti Factor Xa level
15780273|NCT04611373|Drug|Acetazolamide Levamisole|Acetazolamide tablet 25mg/ tablet, 2 tablets a day Levamisole 25mg/ tablet, 6 tablets/day Continue treatment until the disease progresses
15780274|NCT04611360|Other|Anodal Transcranial Direct Current Stimulation Group|"Experimental group were received anodal transcranial direct current stimulation and conventional training exercises for 3 days a weeks for 6 consecutive weeks on alternate days.
~Anodal tDCS were given through:
~i. Anodal electrode:It has been placed over primary motor cortex(ipsilesional) ii. Cathodal electrode: It has been above contralateral eye. iii. Intensity: 2mA iv Density: 0.07C/cm2 iv. Duration:20 min vi Rectangular electrodes(25cm2 ) inserted in saline soaked sponge used"
15780275|NCT04611360|Other|Conventional Training Exercises Group|Conventional physical exercises were given for 3 days a week on alternate days upto 6 weeks. It includes: progressive Conventional Training Exercises : From Bridging,Sitting: weight-bearing, Standing: weight-bearing, Sit to stand, Squat exercises and Tandem walk.
15780276|NCT04611347|Drug|CBD|Topical CBD application for thumb basal joint osteoarthritis.
15780277|NCT04611347|Drug|Shea Butter|Placebo Shae Butter for comparison
15780278|NCT04611334|Behavioral|heart rate variability biofeedback|Heart rate variability biological feedback training is carried out in the outpatient meeting room of the hospital, including once a week, 30 minutes of hospital training each time, using Medea physiological feedback device portable Bluetooth physiological signal Feedback system (Medical Device Input No. 027390). Designed as two stages, stage one (the first week) first teaches the subject how to perform abdominal breathing, and connects the physiological feedback device to monitor the patient's breathing and heart rate changes, and sets the breath per minute according to the subject's resonance frequency . Stage two (second-four weeks) guide the case to understand the resonance relationship between breathing and heart rate, and then achieve the effect of matching heart and breath. It is also equipped with a pressure relief device (Helico Inc., New York, NY, USA) for self-practice at home.
15780279|NCT04611321|Drug|IBI318|IBI318 will be given fixed dose via intravenous (IV) infusion on Day 1 of each 14-day cycle until disease progression or loss of clinical benefit.
15780280|NCT04611308|Other|C1q tumor necrosis factor-related protein 6 levels|C1q tumor necrosis factor-related protein 6 is a tumor marker
15780281|NCT04611295|Procedure|Teleneurological evaluation and support|The study is aimed at developing a remote neurological consultancy system (teleconsultation) for patients with acute neurological symptoms in charge of hospital facilities without 24-hour availability of neurologist consultant.
15780282|NCT04611282|Procedure|surgical techniques in the treatment of localized gingival recession defects.|Micro or macrosurgical echniques were performed using a coronally positioned flap with a subepithelial connective tissue graft.
15780283|NCT04611256|Biological|MSC|Two intravenous infusion of 1*10E6 adipose tissue derived-MSCs /kg body weight reach
15780287|NCT04611243|Biological|Vaccination with Coronavac vaccine|Healthy individuals to receive Coronavac vaccine 2 doses, 21 days apart
15780288|NCT04611243|Biological|Vaccination with BionTech Vaccine|Healthy individuals to receive BionTech vaccine 2 doses, 21 days apart
15780291|NCT04611204|Other|Descriptive cohort|NT-proBNP assay, electrocardiogram and transthoracic echocardiography before CTS surgery release. Pathological analysis for amyloid deposits of transverse carpal ligament of patients included.
15780294|NCT04611178|Device|Mechanical thrombectomy|Stent retriever for treatment of cerebral arterial occlusions
15780295|NCT04611165|Drug|Nivolumab|"Nivolumab 3mg/kg IV is administered as 30-minute IV infusion every 2 weeks.
~EBRT begins 2-7 days after the first dose of nivolumab.
~The follow-up phase begins when the decision to discontinue study is made. The follow-up phase is defined as the day after the end of study treatment until the day the subject dies."
15780296|NCT04611152|Drug|KSI-301|Intravitreal Injection
15780297|NCT04611152|Drug|Aflibercept|Intravitreal Injection
15780298|NCT04611152|Other|Sham Procedure|The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
15780299|NCT04611139|Drug|SP-2577|Daily oral doses
15780300|NCT04611139|Drug|Pembrolizumab|200mg Q3W by IV infusion
15780301|NCT04611126|Drug|Ipilimumab|Ipilimumab 3 mg/kg is administered 2-6 weeks before surgical removement of the tumor. The medicine is administered i.v. over 30 minutes.
15780302|NCT04611126|Drug|Cyclophosphamid|Cyclophosphamide 60 mg/kg is administered i.v. on day -7 and day -6.
15780303|NCT04611126|Drug|Fludarabine Phosphate|Fludarabine 25 mg/m2 is administered on day -5 to day -1.
15780304|NCT04611126|Biological|Tumor Infiltrating Lymphocytes infusion|Tumor-infiltrating lymphocytes grown ex-vivo from resected from cancer tissue and reapplied to the patient via an intravenous infusion. The maximum number of expanded TILs are infused over 30-45 minutes on day 0.
15780305|NCT04611126|Drug|Nivolumab|Nivolumab 240 mg i.v. is administered on day -2 and every 2 weeks for a total of 4 doses. The medicine is administered over 30 minutes.
15780306|NCT04611126|Drug|Relatlimab|Relatlimab 80 mg i.v. is administered on day -2 and every 2 weeks for a total of 4 doses. The medicine is administered over 60 minutes.
15780307|NCT04611113|Dietary Supplement|Immunonutrition|In addition to nutritional counseling, patients will receive two servings of an oral high-calorie-high-protein nutritional liquid supplement enriched in immunonutrients (Impact®). The intervention will start 10-15 days before anticancer treatment initiation and will continue until treatment termination or dropout.
15780308|NCT04611113|Dietary Supplement|Control Nutritional Support|In addition to nutritional counseling, patients will receive two servings of an oral high-calorie-high-protein nutritional liquid supplement. The intervention will start 10-15 days before anticancer treatment initiation and will continue until treatment termination or dropout.
15780309|NCT04611100|Device|ELRA endoluminal radiofrequency ablation electrode (Taewoong, Seoul, Korea)|Intraductal radiofrequency ablation using ELRA endoluminal radiofrequency ablation electrode (Taewoong, Seoul, Korea) 10W 2 minutes at the obstructed bile duct before placing uncover self-expandable biliary metal stent
15780310|NCT04611087|Behavioral|Discussion|Attend focus groups
15780311|NCT04611087|Other|Interview|Attend interviews
15780312|NCT04611087|Other|Survey Administration|Ancillary studies
15780313|NCT04611061|Drug|Kagocel|Investigators could prescribe other drugs in frame of routine clinical practice
15780314|NCT04611061|Drug|No one|Investigators don't prescribe any antiviral drugs in frame of routine clinical practice
15780315|NCT04611048|Diagnostic Test|Thermal QST (CDT, WDT, CPT, HPT) with the method of limits|The testing will be carried out using the classical method of limits, i.e. a continuous heating/cooling stimulus will be applied to the skin at a rate of 1°C/s, until the subject signals that he/she felt the targeted sensation by pressing a button (Rolke, Baron, et al., 2006). The temperature reached by the time the subject pressed the button will be considered the threshold. Baseline temperature will be set at 32°C. The stimuli will not go lower than 0°C and higher than 50°C.
15780316|NCT04611048|Diagnostic Test|Thermal QST (cold and warm detection, heat pain) with the psi method|The Psi algorithm is a method using Bayesian statistics to determine not only the threshold but also the slope of the psychometric function (relationship between the intensity of a stimulus and its detection probability; Kingdom & Prins, 2010). The algorithm selects the next stimulus intensity to be the most informative on the parameters of interest, based on the prior probability density. After each stimulation, the subject will be asked if he/she felt it (as painful) or not. Based on that answer, a posterior probability density is computed. This posterior is then used as prior for the next stimulation. The stimuli will last maximum 1 s and temperature will be kept between 0°C and 60°C.
15780317|NCT04611048|Diagnostic Test|Neurological examination|A standardized neurological examination will be performed to assess all the items included in the Utah Early Neuropathy Scale (UENS ) (Singleton et al., 2008) and the Toronto Clinical Neuropathy Score (TCNS)(Perkins, Olaleye, Zinman, & Bril, 2001). This will include: questions about symptoms (presence or absence of foot pain, numbness, tingling, weakness, imbalance and upper limb symptoms); evaluation of knees and ankles deep tendon reflexes; evaluation of pinprick, temperature, light touch, vibration (128 Hz tuning fork) compared to that of an unaffected sites (e.g., sternum); position sensation in the big toes; mapping of pinprick sensitivity in the lower leg; and evaluation of the active extension of the big toes. Pinprick evaluation will be performed using a disposable pin designed for that purpose (Medipin, The United-Kingdom).
15780318|NCT04611035|Device|QPOP|QPOP will then be applied to establish the most efficacious drug combination for the specific organoid. Additional drugs other than those listed above may be screened depending on availability of cancer organoids. When patients progress after first-line treatment, QPOP generated second-line options will be informed to treating physicians and the physician will exercise his/her discretion to select the most suitable drug based on patient's comorbidities and organ function after a formal molecular/phenotype tumour board.
15780319|NCT04611022|Behavioral|HPV Educational Intervention|The videos are 8-minute narrative films created using an entertainment-education (E-E) approach that embeds an educational narrative message into an entertainment format such as media. E-E narratives have demonstrated a significant effect (r = .12, p < .001) on health behavior change. Evidence-based small media interventions that Dr. Borrayo has produced include videos that are highly verbal, visual, and entertaining (e.g., acted fictional stories). The aims of the video will be to model uptake of the HPV vaccine, but also to reinforce self-efficacy, subjective norms, and behavioral intentions, all significant precursors to behavior change.
15780320|NCT04611009|Behavioral|motor training|In the sensorimotor training program task-specific and non-task specific aspects will be combined. It will start with assignments to improve general finger and wrist movements. After four weeks more specific writing exercises will be added.
15780321|NCT04611009|Behavioral|mindfulness exercises|The awareness training will contain mindfulness exercises. The goal is to consciously experience the here and now in sensual perception of oneself and the environment.
15780322|NCT04610983|Dietary Supplement|Experimental: Control|2 x algal oil gel capsules delivering 400mg DHA in total
15780323|NCT04610983|Dietary Supplement|Experimental: Treatment 1 - Semi-Solid food matrix|"Test Food 1: 200g serve soup + ingredient"
15780324|NCT04610983|Dietary Supplement|Treatment 2 - Solid food matrix|"Test Food 2: 50g serve extruded snack (savoury snack) + ingredient"
15780325|NCT04610970|Drug|TQ-B3525 tablets|TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle.
15780326|NCT04610957|Drug|Rosafem (FEMININE FORMULA)|Rosafem is the only phytoestrogen product with the convenient dose which provides significant improvement of menopausal related symptoms premenstrual syndrome symptoms
15780327|NCT04610944|Behavioral|Changing Talk Online (CHATO)|Three, one-hour training modules highlighting barriers and ineffective communication behaviors with older adults while teaching and modeling alternative, effective communication.
15780328|NCT04610931|Behavioral|Virtual Reality-Enhanced Cognitive Behavioral Therapy (VR-CBT)|"Participants are smokers seeking treatment. Patients will be randomized into one of the 2 intervention groups.
~In all cases, patients will receive nicotine replacement therapy. The second physician in charge of the usual tobacco monitoring will adjust the dosage.
~Subjects in the usual treatment group will receive 6 weekly individual cognitive behavior therapy sessions lead by a psychologist. The content of CBT is similar in both groups. Subjects in the Virtual Reality group will receive 6 weekly individual CBT sessions followed by 6 virtual therapy sessions. Virtual therapy consists of exposing the patient to 3D situations considered to cause a high risk of smoking relapse and aiming to reduce signal reactivity by extinction. At each session, a neutral exposure will be given at the beginning to facilitate immersion and emergence of the session with a duration determined according to the sensitivity of each patient. Exposure is stopped when the craving approaches the baseline level."
15780329|NCT04610931|Behavioral|cognitive behavior therapy|"Participants are smokers seeking treatment. Patients will be randomized into one of the 2 intervention groups. In all cases, patients will receive nicotine replacement therapy. The second physician in charge of the usual tobacco monitoring will adjust the dosage.
~Subjects in the usual treatment group will receive 6 weekly individual cognitive behavior therapy sessions lead by a psychologist. The content of CBT is similar in both groups."
15780330|NCT04610905|Behavioral|Reducing sedentary behaviour|This group needs to download an app on their computer and their smartphone. This app will give a notification every 30 minutes to walk during 2 minutes during working hours. The participants will receive a diary to write down whether they stand up.
15780331|NCT04610905|Behavioral|Increase physical activity|This group will be asked to be more physically active. They need to be active during 150min/week. It can include walking, to ride a bike, jogging, tennis, football,... Additionnaly they need to be active in periods of at least 10 minutes. The participants will receive a diary to write down which activity they did and also for how long.
15780332|NCT04610892|Biological|MEDI6570|MEDI6570
15780333|NCT04610892|Biological|Placebo|Buffer
15780334|NCT04610879|Drug|Carbamazepine|Treatment will be procured, prescribed and issued as per routine NHS practice. Generics can be prescribed.
15780335|NCT04610879|Drug|Levetiracetam|Treatment will be procured, prescribed and issued as per routine NHS practice. Generics can be prescribed.
15780336|NCT04610879|Behavioral|Parent based sleep (PBS) intervention|The PBS intervention is an e-learning package for parents/primary carers and children with epilepsy. The PBS intervention offers parents education about normal sleep, advice about sleep-promoting practices and targeted strategies parents can employ to help their children to ''learn'' an appropriate set of sleep behaviours/habits and/or to unlearn inappropriate sleep behaviours.
15780337|NCT04610866|Drug|Mitapivat|Investigational drug mitapivat (also known as AG-348, AGI-1480 and AGX-0841) is an orally bioavailable, broad-spectrum allosteric activator of alleles of the RBC-specific form of pyruvate kinase (PKR), as well as liver-type pyruvate kinase (PKL) and muscle pyruvate kinase (PKM1 and PKM2).
15780338|NCT04610853|Diagnostic Test|rotational thromboelastometry|ROTEM will be conducted and DIC score calculated within 24 hours after the diagnosis of Sepsis as well as on day 3 and 5 of ICU stay
15780339|NCT04610840|Procedure|Puncture of the caliceal system|Puncture of the caliceal system under ultrasound/Xray control
15780340|NCT04610827|Drug|Ferrous sulfate|Guideline-recommended 3 mg/kg/day dosing
15780341|NCT04610801|Drug|Nasal Spray|Randomized to placebo and Xlear
15780342|NCT04610775|Other|Order of cuff sizes during blood pressure measurements|Each participant will have 4 sets of 3 blood pressure measurements taken. The participants will be randomized to the order in which the cuff sizes are used.
15780343|NCT04610762|Diagnostic Test|GeneXpert HCV VL Fingerstick test|The participants will have a molecular test (GeneXpert HCV VL Fingerstick, Cepheid) that quantifies hepatitis C virus (HCV) RNA levels directly from a fingerstick blood sample.
15780344|NCT04610736|Drug|Temozolomide Oral Suspension|One prescribed oral dose (range 75 to 200 mg/m2) once daily for 5 days
15780345|NCT04610710|Procedure|Operation|Operation for deep infiltrating endometriosis
15780346|NCT04610710|Procedure|Fertility treatment|In vitro fertilisation (IVF) and IVF-intracytoplasmic injection (ICSI)
15780347|NCT04610697|Behavioral|Cognitive Remediation|Cognitive Remediation consists of exercises, preferably supported by coaching, aimed at engaging cognitive skills and, as a result, at improving cognition as well as functional and clinical outcomes.
15780743|NCT04607746|Device|Capsule Endoscope|Capsule endoscope used to view colonic mucosa
15780348|NCT04610697|Behavioral|Active Control|Active control condition for cognitive remediation, matched in terms of session modality, number, duration, frequency, and format.
15780349|NCT04610684|Drug|Carboplatin|Carboplatin 5-6 mg/mL/min AUC will be delivered over 30 - 60 minutes intravenously on Day 1 of each 21 day Cycle after completion of atezolizumab. For 4 cycles.
15780350|NCT04610684|Drug|Etoposide|Etoposide 80-100 mg/m2 will be delivered over 60 minutes intravenously on Days 1-3 of each 21 day Cycle after completion of carboplatin (Day 1 only). For 4 cycles.
15780351|NCT04610684|Drug|Atezolizumab|Atezolizumab 1200 mg will be delivered over 60 (± 15) minutes intravenously on Day 1 of each 21 day Cycle for 4 cycles then continue as monotherapy maintenance with the same schedule.
15780352|NCT04610671|Drug|CG0070|CG0070 will be administered at a dose of 1x10^12 vp intravesically following a sequence of bladder washes with 5% DDM and normal saline.
15780353|NCT04610671|Drug|Nivolumab|Two neoadjuvant doses of nivolumab 480 mg Q4W (every 4 weeks) for 2 doses (week 2 and 6)
15780354|NCT04610658|Drug|Nivolumab|Participants will receive 1 mg/kg Nivolumab on Day 1 of each treatment cycle for 4 cycles (induction immunotherapy). After 4 treatment cycles, Nivolumab will be continued at a flat dose of 360 mg.
15780355|NCT04610658|Drug|Ipilimumab|Participants will receive 3mg/kg Ipilimumab on Day 1 of each treatment cycle for 4 cycles (induction immunotherapy). After 4 cycles, Ipilimumab will be discontinued.
15780356|NCT04610658|Drug|Lurbinectedin|Participants will be treated at 1 of 3 dose levels of Lurbinectedin, beginning at 1.5 mg/m^2 and increasing to 3.2 mg/m^2 or the Maximum Tolerated Dose (MTD)
15780357|NCT04610645|Device|OCT|3x3 OCT volume scans on treated and opposite side of the irreadiated area on head and neck
15780358|NCT04610645|Device|Dermatoscope|2x2 pictures taken with a dermatoscope
15780359|NCT04610645|Genetic|3-Colour FISH|Blood sample is examined for breaks per metaphase to determine radiation sensibility of the individual
15780360|NCT04610632|Diagnostic Test|home pregnancy test|use of home pregnancy test
15780361|NCT04610619|Other|Immunological challenge|In vitro immunological study of subjects with RYR1 related MH/rhabdomyolysis. Studying of circulating cytokines and cytokines production after in vitro stimulation
15780362|NCT04610606|Behavioral|Multimodal intervention (MM)|"Exercise: Moderate intensity resistance and aerobic exercise, including one weekly supervised session and a home-based program. Participants were asked to 1) accumulate 30 min of aerobic exercise per day of their preferred type (ex. walking) and 2) perform 30 min of resistance exercise targeting major muscle groups, every second day for 2 sets of 8-12 reps.
~Nutrition: Optimize diet with protein-rich foods to meet protein intake of >1.2 g/kg/d and energy of 25-30 kcal/kg/d. The supplement consists of whey protein isolate (with the goal of reaching 1.5 g/kg/d, providing 25 g/meal), 6g of leucine, fruit-flavored fish oil added with vitamin D.
~Relaxation strategies: private consultations with psychology-trained personnel whereby techniques aimed at reducing anxiety are practiced. Participants are also provided with a compact disc with relaxation exercises to be used at home 2-3 times per week."
15780363|NCT04610593|Behavioral|Mindfulness-based Intervention|A mindfulness-based intervention will be developed for chronic hemodialysis patients to be performed during hemotherapy sessions. This is an integrative mind-body program, which is based on the MBRP (Bowen et al., 2014) and BMT (T. Russell, 2015) protocols. The program will be conducted in eight weeks, with a weekly individual session of up to 60 minutes facilitated by an instructor, at the bedside during the HD session. The program aims to develop awareness of bodily sensations, emotions and thoughts, with an attitude of openness, curiosity, kindness and non-judgment. During the sessions will be worked four main techniques of mindfulness meditation: mindfulness in breathing, body scanning, conscious movements and practice of compassion. Participants are invited and encouraged to practice Mindfulness using audios made available during the other HD sessions they undergo during the week, in addition to daily home practice.
15780364|NCT04610580|Drug|ALXN1840|ALXN1840 will be administered orally.
15780365|NCT04610567|Drug|Methotrexate-LDE phase 1|"3 patients will receive MTX-LDE at the dose of 15mg IV each 7 days during hospitalization, up to 3 times . After that, 9 patients will receive MTX-LDE at the dose of 30mg IV each 7 days during hospitalization, up to 3 times .
~All patients will receive Leucovorin (calcium foliate) 25mg IV, 24hr after administration of MTX-LDE"
15780366|NCT04610567|Drug|Methotrexate-LDE phase 2|44 patients will receive MTX-LDE at the dose of 30mg IV each 7 days during hospitalization, up to 3 times dose of 30mg IV each 7 days during hospitalization, up to 3 times . All patients will receive Leucovorin (calcium foliate) 25mg IV, 24hr after administration of MTX-LDE
15780367|NCT04610567|Drug|Placebo-LDE phase 2|44 patients will receive Placebo-LDE IV each 7 days during hospitalization, up to 3 times dose of 30mg IV each 7 days during hospitalization, up to 3 times . All patients will receive Leucovorin (calcium foliate) 25mg IV, 24hr after administration of Placebo-LDE
15780368|NCT04610541|Drug|Remdesivir-HU|Remdesivir-HU 100 mg concentrate for solution for infusion
15780369|NCT04610528|Drug|U3 1402|U3-1402 is an antibody drug conjugate (ADC) comprising a recombinant fully human anti-human epidermal growth factor receptor (HER) 3 immunoglobulin G1 (IgG1) monoclonal antibody (patritumab, U3-1287) covalently conjugated to a drug-linker (MAAA-1162a) containing a drug component (MAAA-1181a)
15780370|NCT04610502|Biological|Administration of Equine immunoglobulin anti SARS-CoV-2|The participants will receive premedication with Acetaminophen 500mg PO, Cimetidine300mg IV and Chlortrimeton 10mg IV. Then the investigators will do the Administration of Equine Imunoglobulin anti SARS Cov 2 on day 1 a vial of 10ml of the drug during 1 hour Intravenously. Then the hospitalized participants will be followed until they are discharged.
15780371|NCT04610489|Diagnostic Test|Quidel Sofia SARS Antigen FIA|Obtained via bilateral mid-turbinate swab.
15780372|NCT04610476|Drug|Prednisolone|Prednisolone oral 1-5 mg/day
15780373|NCT04610476|Drug|Sulfasalazine|Sulfasalazine oral 2 x 1000 mg/day
15780374|NCT04610476|Drug|Leflunomide|Leflunomide oral 20 mg/day
15780375|NCT04610476|Drug|Methotrexate|Methotrexate oral > 10 - 30 mg/ week/ 10 mg/week/ 7.5 mg/week; s.c. 15 (7.5 -25) mg/week
15780376|NCT04610476|Drug|Tofacitinib|Tofacitinib oral 2 x 5 mg/day/ 1 x 5 mg/day/11 mg/day
15780377|NCT04610476|Drug|Apremilast|Apremilast oral 2 x 30 mg/day/1 x 30 mg/day
15780378|NCT04610476|Drug|Etanercept|Etanercept s.c. 2 x 25 mg /week OR 1 x 50 mg/week
15780379|NCT04610476|Drug|Adalimumab|Adalimumab s.c. 40 mg every 2 weeks
15780380|NCT04610476|Drug|Infliximab|Infliximab i.v. 5 mg/kg BW every 8 weeks
15780381|NCT04610476|Drug|Certolizumab pegol|Certolizumab pegol s.c. 1x 200 mg every 2 weeks/1x400 mg every 4 weeks
15780382|NCT04610476|Drug|Golimumab|Golimumab s.c. 1x 50 mg every 4 weeks
15780383|NCT04610476|Drug|Abatacept|Abatacept s.c. 1x125 mg/week OR Abatacept i.v. 500-1000mg (adapted to BW) every 4 weeks
15780384|NCT04610476|Drug|Secukinumab|Secukinumab s.c.1x 150 mg OR 1x 300 mg every 4 weeks
15780385|NCT04610476|Drug|Ixekizumab|Ixekizumab s.c. 1x 80 mg every 4 weeks
15780386|NCT04610476|Drug|Ustekinumab|Ustekinumab s.c. Maintenance dose 1x45 mg every 12 weeks
15780387|NCT04610463|Diagnostic Test|Cardiac flow measurement|Catheterized hemodynamics evaluation - a measurement of systemic flow and pulmonary flow, R-L shunt, L-R shunt using the INNTHERM® system, prior to PFO closure using a common PFO-occluder (within one catheterization intervention).
15780388|NCT04610450|Device|HEARO|Robotic system for otological procedures
15780389|NCT04610450|Device|OTOPLAN|Otological surgical planning software
15780390|NCT04610437|Procedure|Arthrodesis interphalangeal with intramedullary resorbable fixation system|Interphalangeal arthrodesis of lesser toes with two different fixation systems.
15780391|NCT04610424|Behavioral|"Cooperative Parent Mediated Therapy (CPMT)"|CMPT usually last 6 months, for a total amount of 15 sessions of 90 min; twelve core sessions (one session per week) are delivered in the first 3 months, followed by 3 monthly booster sessions. Each weekly core session had a specific focus and specific intervention strategies based on active parent coaching during parent-child interaction, and included the parent-child dyad with the parent being actively coached by a trained therapist. Live active coaching increases parents' competence in implementing strategies to enhance child development, and at the same time increases their confidence. This intervention has demonstrated evidence of effectiveness in socio-communicational improvement as measured by ADOS-G (Valeri, 2019) in a randomized controlled trial (RCT).
15780392|NCT04610424|Behavioral|As usual|Speech Language Therapy and Occuapational Therapy provided as usual by National Health Services
15780393|NCT04610411|Device|surgical navigation|surgical navigation for pedicle screw placement and rod beinding using AR-glasses and a specially developed software
15780394|NCT04610411|Other|standard surgical method|standard surgical method established at the institution
15780395|NCT04610398|Drug|Dexamethasone 4mg|s. arm/group description
15780396|NCT04610398|Drug|NaCl 0.9%|s. arm/group description
15780397|NCT04610385|Procedure|radical cystectomy with urinary diversion|surgical removal of the urinary bladder and other organs and perform a urinary shunt
15780398|NCT04610372|Radiation|Hypofractionated external beam radiotherapy|5500 cGy/20 fractions delivered 5 days per week over 4 weeks
15780399|NCT04610372|Radiation|High dose rate brachytherapy|A single fraction of 19 Gy is delivered from an automated afterloading Iridium-192 source via interstitial catheters placed under ultrasound guidance
15780400|NCT04610372|Radiation|Permanent seed implant|Iodine-125 radioactive seeds are implanted permanently in the prostate in a single procedure under transrectal ultrasound guidance
15780401|NCT04610372|Radiation|Stereotactic body radiotherapy|External radiation using SABR technology delivers 36.25 Gy to the prostate in 5 fractions given either once weekly for 5 weeks or every second day over 2 weeks.
15780402|NCT04610359|Drug|MR-MC-01|Submucosal injection of 2.0 x 10,000,000/5ml (1mL * 5 sites)
15780404|NCT04610333|Behavioral|Modified MBSR programme|1 hour group session once a week in 10 weeks
15780405|NCT04610320|Drug|Daratumumab-SC|>Daratumumab-SC 1800 mg subcutaneous weekly for 8 doses and then every other week for 2 doses.
15780406|NCT04610307|Procedure|buffered anesthesia|patients will undergo surgery under buffered local anesthesia
15780407|NCT04610294|Device|Functioning Aerus air filtration/sterilization|"Two units of Aerus air sterilization system will be used in each operating room, and each will be set to high. Units used for the trial will be modified internally to be active and will be sealed to prevent operating room personnel from opening the system and determining a unit's status."
15780408|NCT04610294|Device|Deactivated Aerus air filtration/sterilization|"Two units of Aerus air sterilization system will be used in each operating room, and each will be set to high. Units used for the trial will be modified internally to be inactivated and will be sealed to prevent operating room personnel from opening the system and determining a unit's status. Units will be inactivated by removing the activated carbon, high-efficiency particulate filter, and ionization chamber. However, the fan will remain active as will the run lights."
15780409|NCT04610281|Device|Inner Garden|"Care actions adapted to the intensity of the states of agitation (The child can be removed from the group while remaining in the same room on a chair with a caregiver. If the problems are too serious, the child can be accompanied to a soothing room where the carer will take care of him/her individually. In units equipped with Inner Garden, the child can use it under semi- supervision of nurses.)"
15780410|NCT04610268|Device|transcranial direct current stimulation|Depending on the location of sEEG electrode implanted in the patient's head, the tDCS electrode (5 cm×7 cm each) was placed on occipital-frontal lobe or bilateral temporal lobe. Current intensity: 2 mA and 4 mA, Stimulus time: 3 min (each stimulus session).
15780411|NCT04610255|Other|Assigned Interventions|"Hot pack for 10 minutes
~TENS for 10 minutes
~Trigger point release if any found.
~Myofascial release
~Home plan for stretching exercises will be prescribed to the patient. Receive two weeks intervention plan, three sessions per week."
15780412|NCT04610255|Other|Dynamic myofascial release|"DMFR involves a manual application of low amplitude, long duration stretch to the fascia and muscle. Participants were instructed to relax as much as possible, and the therapist proceeded to smoothly move the joints in a diagonal or horizontal direction at a slow rate within the ROM. The therapist repeatedly pushed, pulled, or shook the joint area about three to five times for about 3 seconds with slight motion at the end of ROM.
~Conventional therapy will includes
~Hot pack for 10 minutes
~TENS for 10 minutes
~Trigger point release if any found.
~Myofascial release
~Home plan for stretching exercises will be prescribed to the patient. Receive two weeks intervention plan, three sessions per week."
15780413|NCT04610242|Diagnostic Test|skin test|"For skin prick tests (SPT), rituximab solution of 1mg/ml was applied on the volar aspect of the forearm. For intradermal tests (IDT), 0.02 mL of a 1:100 dilution (0.1mg/ml) of full-strength solution (10mg/ml) was injected first. If the result was negative, a 1:10 dilution（1mg/ml）was then used.
~As to the desensitization protocol, three solutions with different concentrations are delivered in 12 consecutive steps, each step increasing the rate of drug administration by 2- to 2.5-fold. Solution 1 is a 100-fold dilution (0.01mg/ml) of the final target concentration, solution 2 is a 10-fold dilution (0.1mg/ml) of the final target concentration, and the concentration of solution 3 is the target concentration (1mg/ml). Each step takes 15 minutes until the target rate of 200ml/h is reached, and the final step is prolonged to complete the target dose. The whole procedure takes about 5.5 hours."
15780414|NCT04610229|Radiation|Hypofractionation guioded by dose painting|1
15780415|NCT04610216|Device|Naida CI M hearing device|speech intelligibility measurement with Naida CI M hearing device
15780416|NCT04610203|Dietary Supplement|25 g Nutralys Pea Protein|To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose +25g Nutralys S85 Plus
15780417|NCT04610203|Dietary Supplement|50 g Nutralys S85 Plus.|To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose+50 g Nutralys S85 Plus .
15780418|NCT04610203|Dietary Supplement|50 g Glucose|To determine the glycaemic response, insulinaemic response, GIP response and GLP-1 response to 50g Glucose
15780419|NCT04610190|Device|Training with Gait Enhancing and Motivating System (GEMS-H) Robot|Training consists of 15 minutes task-specific training and 30 minutes functional gait training on varied environments with device.
15780420|NCT04610164|Drug|Tranexamic acid|Prior to surgery, the patient will receive 1 gram of IV TXA
15780421|NCT04610151|Other|guided imagery|Guided Imagery CD: A guided imagery CD was prepared by a web designer with the recommendations of the researcher to include relaxing, soft and slow-paced, mixed nature sounds and photographs towards reducing pain in lower extremity surgical operation patients. The directives used for guidance, the audio recordings created as a result of literature review and the video lasted for 13 minutes (
15780422|NCT04610138|Drug|CNM-ZnAg|ZnAg liquid solution
15780423|NCT04610138|Drug|Placebo|Water
15780424|NCT04610125|Biological|Auto CAR-T|Biological: Auto CAR-T
15780425|NCT04610125|Drug|Cyclophosphamide,Fludarabine|Drug: Cyclophosphamide,Fludarabine
15780426|NCT04610125|Procedure|Leukapheresis|Leukapheresis
15780427|NCT04610112|Device|cochlear implantation|patients receive a cochlear implantation within clinical routine
15780428|NCT04610099|Device|Banded Sleeve Gastrectomy|banded sleeve gastrectomy
15780429|NCT04610099|Device|Standard SG|Standard SG
15780430|NCT04610073|Behavioral|Interactive multimedia training and illustrated booklet|The experimental groups conducted interactive multimedia training and illustrated booklet
15780431|NCT04610060|Behavioral|Power walking|"Exercise in the form of Power walking at hospital for 10-20 minutes on treadmill with various exercise intensities. Weekly Steps at home 30 minutes walking with target to reach 1000 steps daily.
~It is a form of exercise where active upper body movement is performed along with usual walking. It is a fast walking exercise done at a speed of 6 to 8 km/h. During power walking the back is kept straight with the centre of gravity moving from heal, sole, and to hallux. There is active swing back and forth movement of elbow joint with 90 degrees of flexion while walking.
~Weekly protocol for power walking
~Week 1 60-65 % of the target heart rate (THR) 5,000 to 7,499 steps/day
~Week 2 65-70 % of the target heart rate (THR) 7,500 to 9,999 steps/day
~Week 3 70-75 % of the target heart rate (THR) >=10,000 steps/day
~Week 4 75-80 % of the target heart rate (THR) >12,500 steps per day"
15780432|NCT04610060|Behavioral|Standardised outpatient cardiac rehabilitation|Standardised Outpatient Cardiac Rehabilitation based on ACSM Guidelines the intervention group received the following four weeks of intense training program
15780433|NCT04610047|Drug|Norketotifen|Oral capsule
15780434|NCT04610047|Drug|Placebo|Oral capsule
15780435|NCT04610034|Behavioral|"Resilient Caregivers"|"Resilient Caregivers is a 7-session group program developed for partner caregivers of patients with cancer (6 weekly sessions and 1 booster session). Each session takes place in groups of approximately 8 participants and lasts for two-and-a-half hours. Sessions 1 to 3 focuses on the caregiver and introduces the resilience components of coping strategies, meta-reflective skill and clarification of values. Sessions 4 and 5 focuses on these components in the relationship between the caregiver and the cancer patient and social support networks respectively, while Session 6 focuses on resilience in relation to self-care and care for the partner. A booster session will be scheduled one month after the end of Session 6 in order to follow-up on the intervention and allow participants to reflect on the benefits and challenges of the program."
15780436|NCT04610034|Other|Care as usual|The control arm will receive usual care, which implies no systematic support.
15780437|NCT04610021|Biological|i-FactorTM Bone graft|In the i-Factor ™ group it will be placed longitudinally in the intertransverse area. Likewise, in both groups, only autologous and bench bone will be placed in the intersomatic cages. The vertebrae where the i-Factor ™ is placed will be noted on the data collection sheet.
15780438|NCT04610008|Other|No intervention. Purely observation|Retrospective image analysis of the shape of the optic nerve head in both groups
15780439|NCT04609995|Behavioral|Incentives|No financial incentive
15780440|NCT04609982|Device|ear plugs|giving half of the patients ear plugs
15780441|NCT04609969|Diagnostic Test|RT-qPCR test|Two concurrent nasopharyngeal swab specimens are collected for each participant. Comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR positive patients is used to assess COVID-VIRO® sensitivity. Conversely, comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR negative patients is used to assess COVID-VIRO® specificity.
15780442|NCT04609969|Diagnostic Test|COVID-VIRO® test|Two concurrent nasopharyngeal swab specimens are collected for each participant. Comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR positive patients is used to assess COVID-VIRO® sensitivity. Conversely, comparison between RT-qPCR and COVID-VIRO® results of RT-qPCR negative patients is used to assess COVID-VIRO® specificity.
15780443|NCT04609956|Other|Virtual reality|Virtual reality consists of a headphones, a virtual reality headset and a smartphone.
15780444|NCT04609956|Other|Standard|Standard arm is the habitual procedure. They use hydroxyzine and music with headphones
15780450|NCT04609930|Drug|Anti-PD-1 or anti-PD-L1|Immunotherapy treatment via anti programmed death 1 and/or anti-programmed death ligand 1.
15780451|NCT04609917|Procedure|trainee invlovement|Patients underwent selective biliary cannulation with trainee involvement
15780452|NCT04609904|Drug|BGF MDI 320/28.8/9.6 μg|Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler
15780453|NCT04609904|Drug|BGF MDI 320/14.4/9.6 μg|Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler
15780454|NCT04609904|Drug|BFF MDI 320/9.6 μg|Budesonide and formoterol fumarate metered dose inhaler
15780455|NCT04609904|Drug|BFF pMDI 320/9 μg|Budesonide/formoterol fumarate pressurized metered dose inhaler
15780456|NCT04609891|Drug|Avatrombopag|"Preventive medication:
~10×109/L<PLT<50×109/L, use avatrombopag oral tablet 60 mg, once a day, 5 days before and after chemotherapy, 10 days in total； 50×109/L≤PLT<75×109/L, use avatrombopag oral tablet 40 mg, once a day, for 5 consecutive days before and after chemotherapy for a total of 10 days.
~Therapeutic medication:
~10×109/L<PLT<50×109/L, use avatrombopag oral tablet 60 mg once a day for 5-10 days； 50×109/L≤PLT<75×109/L, use avatrombopag oral tablet 40 mg once a day for 5-10 days."
15780461|NCT04609865|Drug|Lidocaine 2%|the lidocaine infusion protocol is a bolus of 1 mg/kg (ideal weight), followed by 3mg/kg/h for the first hour, 1.5 mg/kg/h for the second hour, 0.72 mg/kg/h for the next 22 hours, and then 0.6mg/kg/h for 14 days or until extubation.
15780462|NCT04609865|Drug|Control|The NaCl 0,9% infusion protocol is a bolus of 0.05 ml/kg (ideal weight), followed by 0.15 ml/kg/h for the first hour, 0.075 ml/kg/h for the second hour, 0.36 ml/kg/h for the next 22 hours, and then 0.03 ml/kg/h for 14 days or until extubation.
15780463|NCT04609852|Drug|E8001|Intravenous infusion.
15780464|NCT04609852|Drug|Placebo|Intravenous infusion.
15780465|NCT04609839|Other|Follow-up of patients with COVID-19|"The presence of sequelae, number of re-hospitalizations, date of death and cost of health expenditure will be collected.
~The Quality of life score (SF-36 questionnaire) and the Pittsburgh sleep quality index (PSQI questionnaire) will be completed by patients."
15780466|NCT04609826|Drug|JNJ-74856665|JNJ-74856665 will be administered orally.
15780467|NCT04609826|Drug|AZA|AZA will be administered IV infusion or SC injection.
15780468|NCT04609826|Drug|VEN|VEN tablet will be administered orally.
15780469|NCT04609813|Procedure|sample collection|Under the guidance of outpatient doctors, nurses or hospital staff who have received uniform training use the Shikang No. 1 collection device to collect cytology samples
15780470|NCT04609813|Other|Training|training
15780471|NCT04609787|Device|Immersive Virtual Reality|Participants are placed in three-dimensional, life-sized computer-generated environments via a computer headset shows potential as a treatment for chronic pain and central sensitization.
15780472|NCT04609774|Other|Severe Acute Respiratory Syndrome CoronaVirus 2 detection|Severe Acute Respiratory Syndrome CoronaVirus 2 Detection by Real-Time Polymerase Chain Reaction and cell culture
15780473|NCT04609761|Drug|Privigen Injectable Product (Intravenous Immunoglobulin)|Privigen, 2 g/kg BW every 4th week for 6 months (= 6 infusions).
15780474|NCT04609748|Drug|Cannabidiol Oil|Cannabidiol oil will be given twice a day, in a dose of 33,6mg, applied orally. The therapy will last 15 days.
15780475|NCT04609748|Drug|Nimesulide|Nimessulid will be given twice a day - 2x100mg, applied orally. The therapy will last 15 days.
15780476|NCT04609735|Other|Electric Dry Needling, Manual Therapy, Exercise and Ultrasound|Electric Dry Needling, Manual Therapy, Exercise and Ultrasound
15780477|NCT04609735|Other|Manual Therapy, Exercise and Ultrasound|Electric Dry Needling, Manual Therapy, Exercise and Ultrasound vs. Manual Therapy, Exercise and Ultrasound
15780478|NCT04609722|Other|Solution-Focused Support Program|All participants will be given a program of 4 sessions for 4 weeks. Each session is planned to last approximately 50 minutes.
15780479|NCT04609709|Other|Thrust Manipulation, Electric Dry Needling and Exercise|Thrust Manipulation, Electric Dry Needling
15780480|NCT04609709|Other|Non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS|Non-thrust Mobilization, Soft-Tissue Mobilization, Exercise and TENS
15780481|NCT04609696|Drug|Danicopan: Powder-In-Capsule 1|Danicopan (200 milligrams) will be administered orally on Day 1.
15780482|NCT04609696|Drug|Danicopan: Powder-In-Capsule 2|Danicopan (200 milligrams) will be administered orally on Day 1.
15780483|NCT04609696|Drug|Danicopan: Tablet|Danicopan (200 milligrams) will be administered orally on Day 1.
15780484|NCT04609683|Device|AleriTM sensors|"AleriTM sensors are worn on the bicep or forearm and communicates through BLETM to a mobile App. The data is sent through the mobile App to web-based system processing where PHI is calculated and sent back to the mobile App.
~The AleriTM sensor has a form factor similar to a conventional arm band, with a hockey puck shape of approximately 48mm in diameter and 15mm in thickness the AleriTM sensor is a non-significant risk (NSR) device as it does not meet the definition of significant risk device (21 CFR 812.3(m)) because it is: not an implant; is not purported or represented to support or sustain human life; its use is not of substantial importance in the diagnosis, cure, treatment, mitigation, or prevention of impairment of health; and it does not present a serious risk to the health, safety, or welfare of a subject."
15780485|NCT04609670|Drug|[14C]-ALXN2050|A single dose of 200 milligrams (~85 microcuries) [14C]-ALXN2050 will be administered orally.
15780486|NCT04609657|Other|Flavored carbonated soft drink (CSD)|Beverage
15780487|NCT04609644|Other|Digital Tools for Asthma Self-Management|Please see description of active study arm.
15780528|NCT04609332|Diagnostic Test|Endothelial damage and angiogenic biomarkers|Blood samples for biomarkers study
15780488|NCT04609631|Behavioral|Tai Chi|24-form Tai Chi will be performed for 12 weeks. Each session contains a warm-up period (10 minutes), a Tai Chi period (40 minutes) and a cool-down period (10 minutes).
15780489|NCT04609631|Behavioral|CBT|CBT will be performed once a week for 12 weeks. Each session lasts for 1 hour.
15780490|NCT04609618|Device|Appscent Device|computer-controlled, low pressure compressed air based, with disposable odorant capsules solution provided an odor environment at the nose,
15780491|NCT04609605|Device|speckle tracking echocardiography|speckle tracking echocardiography of right ventricle
15780492|NCT04609592|Drug|Lutathera|4 administrations of 7.4 gigabecquerel (GBq) (200 mCi) 177Lu Dotatate +/ 10% at the date and time of infusion, accumulative dose of 29.6 GBq (800 mCi). T
15780493|NCT04609592|Drug|Gallium 68 Dotatate|Standard of care, 2 Megabecquerel (MBq)/kg (0.054 mCi/kg) up to 200 MBq (5.4 mCi)
15780494|NCT04609592|Procedure|Computed Tomography (CT)|Medical Imaging
15780495|NCT04609592|Procedure|Magnetic Resonance Imaging (MRI)|Medical Imaging
15780496|NCT04609592|Procedure|PET/CT|Medical Imaging
15780497|NCT04609579|Drug|SNX281|SNX281 will be administered as an intravenous infusion on Days 1, 8, and 15 in Cycle 1 and on Day 1 of each subsequent cycle thereafter of each 21-day cycle (for up to 6 cycles, or until disease progression or unacceptable toxicity occurs). Cycle 1 length varies from 21 days in monotherapy arm to 28 days in the combination arm
15780498|NCT04609579|Drug|Pembrolizumab|Pembrolizumab will be administered as an intravenous infusion on Day 8 in Cycle 1 (28-day cycle) and on Day 1 of each 21-day cycle thereafter (for up to 6 cycles, or until disease progression or unacceptable toxicity occurs).
15780501|NCT04609553|Behavioral|Usual care including ROR|Usual care which includes ROR.
15780502|NCT04609553|Behavioral|Text messages|3 text messages per week and one interactive text per month.
15780503|NCT04609553|Behavioral|Connection to community resources|Referral to a non-profit that connects families with community resources and provides families with case management.
15780504|NCT04609540|Drug|Trastuzumab|Dual anti-HER2 therapy
15780505|NCT04609527|Procedure|Management of placenta accreta spectrum|Conservative and radical (hysterectomy) treatment of placenta accreta. Follow up to the patients to detect the impact of treatment imposed A novel technique which early identification and repait of uterine wall defects resulted from invasion of the uterine wall by the placenta.
15780506|NCT04609514|Device|Learn to Quit-HIV|A smartphone app developed by the research team designed for people with HIV that provides Acceptance and Commitment Therapy skills to address smoking cessation.
15780507|NCT04609514|Behavioral|QuitGuide|A smartphone app developed by the National Cancer Institute which uses smoking cessation recommendations contained in the US DHHS Clinical Practice Guidelines.
15780508|NCT04609514|Drug|Nicotine patch|All participants will receive an 8-week course of nicotine patches. They will start off with 4 weeks of 21mg/24 hours patches, then move to 2 weeks of 14mg/24 hours patches, and finally end with 2 weeks of 7mg/24 hours patches.
15780509|NCT04609514|Behavioral|Smartphone coaching|All participants will partake in over-the-phone smartphone coaching lead by the PI or a research assistant. This will be a time for participants to bring up any technical issues they are experiencing with the study smartphone or app.
15780510|NCT04609488|Diagnostic Test|Surfactant assessment|To determine surfactant levels in lung fluid
15780511|NCT04609475|Procedure|Osseodensification technique|Implant bed preparation will be performed according to the manufacturer's guidelines, densifying burs (Densah® Burs) will be used sequentially in densifying mode (counterclockwise drill speed 800-1500 rpm with copious irrigation) to achieve the planned osteotomy diameter and desired ridge expansion. The implant will be then placed in the prepared osteotomy
15780512|NCT04609475|Procedure|Motor driven expanders' technique|The technique consisted of preparing the implant bed by progressively increasing the size of the osteotomes until the desired expansion will be achieved. At the planned implant site, a pilot drill 1000 rpm with irrigation until the desired length, then expansion with the series of ridge spreaders and finally using the final drill. The implant will be then placed in the prepared osteotomy.
15780513|NCT04609462|Procedure|Conventional oxygen therapy|Oxygen therapy by conventional nasal cannula / prongs, venturi mask, or mask with reservoir
15780514|NCT04609462|Procedure|High flow nasal cannula|Breathing support with High-flow nasal cannula
15780515|NCT04609449|Procedure|Long biliopancreatic limb Roux-en-Y gastric bypass.|Long biliopancreatic limb Roux-en-Y gastric bypass.
15780516|NCT04609449|Procedure|Standard Roux-en-Y gastric bypass|Standard Roux-en-Y gastric bypass
15780517|NCT04609436|Device|"Cardiac monitoring with the wireless device SmartCardia"|Monitoring of arrhythmia with a wireless device (SmartCardia)
15780518|NCT04609423|Dietary Supplement|Cod liver oil|5 ml of cod liver oil as a source of 10 ug of vitamin D and 1.2 g of long-chained n-3 polyunsaturated fatty acids (DHA 0,6g and EPA 0,4g) per day for 6 months x 1 time/day together with the first meal of the day. 5ml of Cod liver oil also contains 250ug vitamin A and 10 mg vitamin E.
15780519|NCT04609423|Dietary Supplement|Corn oil (placebo)|5 ml of corn oil per day for 6 months x 1 time/day together with the first meal of the day
15780520|NCT04609410|Procedure|Neuromuscular blockade|Neuromuscular blockade will be achieved via rocuronium intravenous administration and level will be monitored with train of four/post tetanic count monitoring
15780521|NCT04609397|Drug|Hemay005|Hemay005 tables 60mg bid p.o;
15780522|NCT04609397|Drug|Hemay005|Hemay005 tables 45mg bid p.o
15780523|NCT04609397|Other|Placebo|placebo to Hemay005 tables bid p.o
15780524|NCT04609384|Device|Alcohol rub timer device|A device that should help the surgeon to increase the time spend on surgical rub. Further detail cannot be described due to confidence
15780525|NCT04609371|Behavioral|self-care tools|self-care tools only
15780526|NCT04609371|Behavioral|lay telephone coaching|coaching
15780527|NCT04609358|Other|intervention group|When patients' hemodynamics was stable, start 1-2ml/kg/hr post-op 6-12 hours and increased 1-2ml/kg/hr each day if tolerating to reach the target energy supply When patients' hemodynamics wasn't stable, start post-op 6-12 hours 0.5-1ml/kg/hr and increased 0.5-1ml/kg/hr each day if tolerating to reach the target energy supply.
15780529|NCT04609319|Drug|Dacomitinib|This is a non-interventional, real world study of Asian patients being treated with dacomitinib as first-line treatment for EGFR+ NSCLC
15780530|NCT04609306|Other|H2O2 application to incision|A lap sponge soaked in 3% H2O2 will be applied to the incision and allowed to sit for 3 minutes.
15780531|NCT04609293|Combination Product|camrelizumab+apatinib+hyperfractionated radiotherapy|Immunotherapy, anti-angiogenesis targeted therapy combined with hyperfractionated radiotherapy
15780532|NCT04609280|Radiation|Intensity modulated radiotherapy (IMRT)/volumetric modulated arc therapy (VMAT) or Pencil beam proton therapy (PBPT)|Delivered over 6 weeks in 30 daily fractions in the adjuvant setting and over 6.5 weeks in 33 daily fractions in the definitive setting. In the adjuvant setting, areas with positive surgical margins or nodal stations with pathologic extranodal extension will receive 63 Gy. Margin negative resection bed and involved nodal stations without extranodal extension will receive 54 Gy. Low-risk elective nodal volumes (i.e. ceCTV) will receive 51 Gy. In the definitive setting, gross disease will receive 69.96 Gy, areas at high-risk for subclinical disease will receive 60 Gy, and areas at low-risk for harboring subclinical disease (i.e. ceCTV) will receive 52.8 Gy.
15780533|NCT04609267|Diagnostic Test|PHQ-9 - Mirror format|The intervention we will be using is a new delivery system of the PHQ-9 using an Amazon Alexa equipped Mirror device. This Mirror device is similar to a smart television with a mirror interface. The device records auditory responses to the PHQ-9. We will be comparing the responses from the Mirror device to those given on the clinically established paper format.
15780534|NCT04609254|Drug|Paracetamol|1000 mg of paracetamol ( parol 1000mg vial-atabay chemistry-İstanbul) intravenous (IV) was given 71 patients,
15780535|NCT04609254|Drug|Dexketoprofen|dexketoprofen 50 mg arveles 50 mg ampoule -Menarini- Istanbul) intravenous (IV) was given 70 patients,
15780536|NCT04609254|Drug|Ibuprofen|400 mg Ibuprofen (İntrafen 400 mg vial- Gen-İstanbul) intravenous (IV) was given 69 patients, which determined to be applied as a group.
15780537|NCT04609241|Drug|CD79b CAR-T Cells|Each subject receive CD79b CAR-Tcells by intravenous infusion
15780538|NCT04609228|Other|Non-acceptance of blood-transfusions|Patients who do not accept blood products transfusions
15780539|NCT04609228|Other|Acceptance of blood-transfusions|Patients who accept blood products transfusions
15780540|NCT04609215|Other|ALECSAT|"Patients will receive concurrent chemotherapy with carboplatin/gemcitabine with cycles repeated every 3 weeks.
~During the loading phase, patients will receive ALECSAT at 28 days intervals at weeks 5, 9, and 13. Hereafter (the maintenance phase), ALECSAT will be administered every 12 weeks until disease progression, death, unacceptable toxicity, investigator/patient decision or EOT visit at 18 months."
15780541|NCT04609202|Behavioral|Nurse led person centred care|Person centred care include patiens narratives, partnership and documentation of a health plan.
15780542|NCT04609202|Other|Usual care|Usual care provided by doctors
15780543|NCT04609189|Drug|Pearlium/EffectiCal|Oral administration of Pearlium/EffectiCal.
15780544|NCT04609189|Drug|Calcium carbonate/vitamin D3|Oral administration of Calcium Carbonate/Vitamin D3
15780545|NCT04609176|Drug|Camrelizumab plus Apatinib and SOX|Camrelizumab 200mg, day1; Apatinib 250mg qd p.o.;Oxaliplatin 130 mg/m2 day1; S-1 40-60 mg (calculated according to the body surface area) bid day1-14. 3 weeks for one cycle.
15780546|NCT04609176|Drug|Camrelizumab plus Apatinib|Camrelizumab 200mg, day1; Apatinib 250mg qd p.o. 3 weeks for one cycle.
15780547|NCT04609163|Other|data collection|retrospective data collection
15780548|NCT04609150|Other|Bone marrow fat quantification by MRI|Bone marrow fat quantification by MRI at the moment of the diagnosis of vertebral fracture before treatment by vertebroplasty
15780549|NCT04609137|Procedure|Early drain removal|"Patients randomized to the experimental group, will have an early drain removal if DFA on POD1 is lower than 2000 U/L and/or the drain fluid does not appear sinister (i.e. varying from dark brown to greenish fluid to milky water to clear spring water pancreatic juice like appearance) according to the clinical team. If DFA is greater than 2000 U/L, the drain will be maintained in place. If the sample on POD1 DFA is not available (e.g. drainage fluid is viscous and amylase value cannot be evaluated) or the sample could not be analyzed DFA will be evaluated on POD2, and drain removal will be considered if DFA is lower than 2000 U/L. If DFA on POD 3 is lower than 300 U/L, that is 3-fold the upper limit of normal serum amylase value, and/or the drain fluid does not appear sinister according to the clinical team, the drain will be removed. Otherwise, the drain will be kept in place and the patient will then follow standard postoperative drain management."
15780550|NCT04609137|Procedure|Standard drain removal|"Patients randomized to this group will receive the current standard of care, thus the drain will be maintained at least until postoperative day 5. If DFA on POD 5 is lower than 3-fold the upper limit of normal serum amylase value, and/or the drain fluid does not appear sinister (i.e. varying from dark brown to greenish fluid to milky water to clear spring water pancreatic juice like appearance) according to the clinical team, the drain will be removed. If the drain is maintained in place beyond POD 5, it will be removed inhospital or after discharge when the daily amount is lower than 10 ml and there are no signs of ongoing infection"
15780551|NCT04609124|Diagnostic Test|Abdominal ultrasound evaluation of antral area|ultrasound assessment of antral cross sectional area
15780552|NCT04609111|Drug|No aspirin|1-month prasugrel monotherapy followed by clopidogrel monotherapy
15780553|NCT04609111|Drug|1-month DAPT|1-month dual antiplatelet therapy comprising of aspirin and prasugrel followed by aspirin monotherapy
15780554|NCT04609098|Drug|Dihydroartemisinin/Piperaquine|Tablets containing 40 mg dihydroartemisinin/320 mg piperaquine (Eurartesim, Sigma Tau), administered according to weight as per the manufacturer instructions.
15780555|NCT04609098|Drug|Tafenoquine 100mg [Arakoda]|Extemporaneous preparation of 1mg/mL Tafenoquine solution, from tablets containing 100mg primaquine (Arakoda, 60degrees pharmaceuticals, DC) dissolved in 100mL water with a non-interacting fruit-flavoured syrup. Solution will be given according to weight as indicated per treatment arm in 5kg bands.
15780588|NCT04608864|Procedure|varicocelectomy|microsurgical subinguinal varicocelectomy
15780589|NCT04608851|Drug|E. coli Nissle|1 ml of oral suspension containing 10 E8 CFU /ml of E. coli Nissle strain
15780556|NCT04609059|Drug|M201-A Injection|"Active Substance: M201-A Route of administration: continuous intravenous injection
~Step 1: Continuous Intravenous Injection administered with single dose of M201-A hydrochloride or placebo 0.4 mg/kg in 50 mL, controlled with a syringe driver at a rate of 2.5 mL/min for 20 minutes Step 2: Continuous Intravenous Injection administered with single dose of M201-A hydrochloride or placebo 0.6 mg/kg in 50 mL, controlled with a syringe driver at a rate of 2.5 mL/min for 20 minutes (Based on recommendations of an independent data monitoring committee; data and safety monitoring board, it will be decided that dosage is 0.20 mg/kg or 0.40 mg/kg. If appropriate, Step 2 will not be conducted.)"
15780557|NCT04609059|Drug|Placebo|"Saline Placebo: M201-A Placebo Route of administration: continuous intravenous injection
~Step 1: Continuous Intravenous Injection administered with single dose of M201-A hydrochloride or placebo 0.4 mg/kg in 50 mL, controlled with a syringe driver at a rate of 2.5 mL/min for 20 minutes Step 2: Continuous Intravenous Injection administered with single dose of M201-A hydrochloride or placebo 0.6 mg/kg in 50 mL, controlled with a syringe driver at a rate of 2.5 mL/min for 20 minutes (Based on recommendations of an independent data monitoring committee; data and safety monitoring board, it will be decided that dosage is 0.20 mg/kg or 0.40 mg/kg. If appropriate, Step 2 will not be conducted.)"
15780562|NCT04609033|Drug|Bupivacaine|instillation of local anaesthetic in the abdominal cavity at the end of the procedure
15780563|NCT04609033|Drug|isotonic saline|instillation of local anaesthetic in the abdominal cavity at the end of the procedure
15780564|NCT04609033|Drug|Bupivacaine + morphine|instillation of local anaesthetic + morphine sulfate in the abdominal cavity at the end of the procedure
15780565|NCT04609033|Drug|Bupivacaine + morphine + ketamine|instillation of local anaesthetic + morphine sulfate + ketamine in the abdominal cavity at the end of the procedure
15780566|NCT04609020|Device|JUVÉDERM|JUVÉDERM VOLBELLA with Lidocaine Treatment of any fine lines and medium-sized skin depressions. Can also be used for enhancement and pouting of the lips to correct structural defects such as asymmetry, contour deformities, volume loss. JUVÉDERM VOLIFT with Lidocaine Intended for the treatment of any deep skin depressions due to conditions such as premature aging. Can also be used for face contouring and volume restoration to correct facial structural defects such as asymmetry, contour deformities, volume loss in the lips, cheeks, chin, lower face. JUVÉDERM VOLUMA with Lidocaine Intended to restore volume of the face JUVÉDERM VOLITE with Lidocaine Intended for treatment, by filling, of superficial cutaneous depressions such as fine lines and for additional improvement of skin quality attributes such as hydration and elasticity. JUVÉDERM VOLUX with Lidocaine Intended to restore and generate facial volume in chin and mandible areas
15780567|NCT04609020|Drug|BOTOX|Indicated for the treatment of hyperkinetic facial lines.
15780568|NCT04609007|Behavioral|Cognitive behavioral therapy (CBT)|A brief 4 sessions online CBT program with therapist support.
15780569|NCT04609007|Behavioral|Regular help-line telephone counselling|A single session of telephone counselling with a help-line counsellor
15780570|NCT04608981|Drug|Prednisolone 30 mg|Steroidal anti-inflammatory drug as a preoperative medication
15780571|NCT04608981|Drug|Diclofenac Potassium 50mg Tab|Non-steroidal anti-inflammatory drug as a preoperative medication
15780572|NCT04608981|Drug|Placebo|Starch
15780573|NCT04608955|Drug|WX-081|WX-081 is not licensed yet. WX-081 will be used in arms A, B, C, WX-081+MBT.
15780574|NCT04608955|Drug|Bedaquiline|This licensed drug will be used in arm F as positive comparator.
15780575|NCT04608955|Drug|Standard treatment|Standard treatment will be used in arm D as positive comparator, according to the recommendations of WHO guidelines for diagnosis and treatment of tuberculosis.
15780576|NCT04608955|Drug|Multi-drug background treatment (MBT)|MBT will be used in arm E, F as background treatment. The drugs used in MBT are all licensed drugs, and the treatment complies with the recommendations of WHO guidelines for diagnosis and treatment of tuberculosis.
15780577|NCT04608942|Device|Jett Plasma Medical Lift|Plasma Application versus Mechanical Debridement in refractory meibomian gland dysfunction
15780578|NCT04608942|Procedure|Mechanical Debridement|Plasma Application versus Mechanical Debridement in refractory meibomian gland dysfunction
15780579|NCT04608929|Behavioral|Kegel exercise-focused interventions|After the patients in the intervention group were interviewed on the telephone, the second home visit. During this visit, the patients were trained on Kegel exercises and they were administered the ICIQ-SF. Six weeks after the second visit, the third home visit was paid to determine whether the patients did the Kegel exercises and whether they did them accurately, to assess the perceived impact and to re-administer the ICIQ-SF. After the 2nd and 3rd visit, the patients were called once a week for 6 weeks to monitor if they kept up with doing the Kegel exercises as they were taught. Six weeks later, the 4th home visit were paid to the patients. During this visit, whether the patients did the Kegel exercises and whether they did them accurately was determined, the perceived impact was assessed and the ICIQ-SF was re-administered.
15780580|NCT04608929|Other|Home visit and scale evaluations|After the 1st visit, the patients included in the control group were called by phone and the 2nd home visit was planned. During the second home visit, the ICIQ-SF was administered to them. At the 3rd home visit paid 6 weeks after the 2nd visit, the ICIQ-SF was re-administered to the patients and the perceived impact assessment was performed. During the 4th home visit paid 6 weeks after the 3rd home visit, the ICIQ-SF was re-administered to the patients, assessment of the perceived impact was performed, and finally they were given training on Kegel exercises.
15780581|NCT04608916|Procedure|Using surgical diathermy to make skin incision|Using surgical diathermy to make skin incision during shoulder arthroplasty
15780582|NCT04608916|Procedure|Using scalpel blade to make skin incision|Using scaple blade to make skin incision during shoulder arthroplasty
15780583|NCT04608903|Dietary Supplement|L-sulforaphane 1%|Administration of 4g L-Sulforaphane per day, for 2 months
15780584|NCT04608903|Dietary Supplement|Placebo Group|Administration of 4g corn starch colored with chlorophyll, per day, for 2 months
15780585|NCT04608890|Diagnostic Test|Eye-tracking video test|An eye-tracking-based test will be administered to patients. It lasts 10 minutes. It consists in several screens passing by to identify objects at a certain time by a mouse clic or touchpad.
15780623|NCT04608552|Behavioral|Nasal Breathing Exercises|Nasal breathing exercises each week
15780590|NCT04608851|Other|Placebo control|1 ml oral syrup consisting of Saccharum 630 mg/g and Aqua purificata 370 mg/g.
15780591|NCT04608838|Biological|JTR-161|JTR-161 (1 or 3 × 10^8 cells/subject) will be suspended and administered in an intravenously infusion.
15780592|NCT04608838|Biological|Placebo|Placebo will be suspended and administered in an intravenously infusion.
15780593|NCT04608812|Drug|OS2966|OS2966 is a humanized monoclonal antibody antagonizing CD29 (Beta 1 integrin)
15780594|NCT04608812|Drug|Gadoteridol|Gadoteridol is a contrast agent which will be added to OS2966 to allow investigators to observe how OS2966 distributes within the brain tumor. Gadoteridol is approved by the FDA for intravenous injection during an MRI scan. It is not approved by the FDA for administration directly into a tumor.
15780595|NCT04608812|Device|Infuseon Cleveland Multiport Catheter|The Infuseon Cleveland Multiport Catheter is an FDA 510(k)-cleared device currently used in clinical studies to deliver therapeutics directly to brain tumors and the surrounding brain tssue.
15780596|NCT04608799|Drug|Perampanel|Efficacy of epilepsy drugs
15780597|NCT04608786|Drug|ZKAB001 5mg/kg|ZKAB001 D1 IV 5mg/kg every three weeks,up to 16 cycles or 1 year
15780598|NCT04608786|Drug|Capecitabine|Capecitabine po 1000mg / m2/time, 2 times/d for 2 weeks, followed by 1 week of stopping ,three weeks is a course of treatment with a total of 8 courses
15780599|NCT04608773|Other|Remineralizing Extreme Dry Mouth Spray with Xylitol|oral hydrating spray
15780600|NCT04608773|Device|Alcohol-Free Moisturizing Dry Mouth Spray|oral hydrating spray
15780601|NCT04608760|Drug|Meksibel|2 ml solution
15780602|NCT04608747|Other|Tahini|Fifty grams of tahini were consumed by 20 healthy males
15780603|NCT04608734|Drug|Buccal midazolam|The drug was sprayed in the buccal vestibule across the area between the primary first and second molars in all four quadrants to maximize the absorption through wide area of the buccal mucosa.
15780604|NCT04608734|Drug|Intranasal midazolam|Half of the dose was sprayed in the right nostril and the other half in the left nostril to double the absorptive surface area by short and quick puffs.
15780605|NCT04608721|Other|Postpartum Anxiety|Postpartum anxiety will be assessed at 1-3 days (T1), 1(T2), 3 (T3), 6 (T4) and 12 months (T5) postpartum by using the State-Trait Anxiety Inventory (STAI) with a score ≥40 serving as a positive screen.
15780606|NCT04608708|Other|The data of patients who had applied to the clinic for various reasons and were diagnosed with fibro-osseous lesions|lesions diagnosed radiologically and followed up for at least one year were included in this study with the help of cone beam computed tomography.
15780607|NCT04608695|Procedure|Ovarian puncture|One side ovary of each patient included in the study, will be punctured 10 times under trans-vaginal ultrasound guidance with 17 gauge ovarian pick up needle, 1 month before the scheduled IVF cycle. Control group will be the other side ovary for each patient. Number of ≥ 14 mm follicle and collected oocytes will be compared.
15780608|NCT04608682|Drug|Sugammadex|The muscle relaxant infusion will be discontinued and 2 mg/kg of sugammadex will be infused, TceMEPs monitoring will be performed 5 minutes later.
15780609|NCT04608682|Drug|Saline|The muscle relaxant infusion will be discontinued and 2ml saline will be infused, TceMEPs monitoring will be performed 5 minutes later.
15780610|NCT04608669|Drug|Paracetamol|Give paracetamol or placebo and compare temperature
15780611|NCT04608656|Other|Provision of livestock feeds|Households will receive livestock feeds (ranch cubes) for the select lactating animals during the dry season
15780612|NCT04608656|Other|Nutrition counselling|Households will receive livestock feeds (ranch cubes) for the select lactating animals and will also be enrolled in to a nutrition counselling programme
15780613|NCT04608643|Diagnostic Test|CBC _inflammatory markers _ platelet function test|CBC , Erythrocte sedimentation rate (ESR) ,CRP, platlet functions tests ( adhesions, 'aggregations ristocetin).
15780614|NCT04608630|Drug|Denosumab 60 MG/ML|Patients allocated to the Denosumab arm will receive Denosumab 60mg in 1ml, administered via subcutaneous injection on Study Days 1 and 180.
15780615|NCT04608630|Drug|Zoledronic Acid 5Mg/Bag 100Ml Inj|Patients allocated to the Zoledronic acid arm will receive Zoledronic acid 5mg in 100ml 0.9% Sodium Chloride, administered via intravenous infusion over at least 15 minutes on Study Day 1.
15780616|NCT04608630|Drug|Sodium Chloride 0.9% Intravenous|Patients allocated to the placebo arm and Denosumab arm will receive 0.9% Sodium Chloride 100ml administered via intravenous infusion over at least 15 minutes on Day 1.
15780617|NCT04608630|Drug|Sodium Chloride 0.9% Injection|Patients allocated to the placebo arm and Zoledronic acid arm will receive 0.9% Sodium Chloride 1ml administered via subcutaneous injection on Days 1 and Day 180
15780618|NCT04608617|Device|Viz LVO (De Novo Number DEN170073)|"Viz LVO is a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, independent of standard of care workflow.
~Viz LVO uses an artificial intelligence algorithm to analyze images for findings suggestive of a pre-specified clinical condition and to notify an appropriate medical specialist of these findings in parallel to standard of care image interpretation. Identification of suspected findings is not for diagnostic use beyond notification. Specifically, the device analyzes CT angiogram images of the brain acquired in the acute setting and sends notifications to a neurovascular specialist that a suspected large vessel occlusion has been identified and recommends review of those images. Images can be previewed through a mobile application."
15780619|NCT04608604|Other|Physiotherapy|Patients will be randomized in either physiotherapy 1 or physiotherapy 2. Physiotherapy programs are individually tailored based on a structured standardized series. In order to not unblind potential participants, detailed description of both interventions will be provided after recruitment has been finished.
15780620|NCT04608578|Behavioral|Silver|A serious game to improve mental health in youth
15780621|NCT04608565|Device|Remote biomonitoring sensor device|Same as described in arm descriptions. Safety was ensured by getting radiant warmer and multichannel probe examined and services by the biomedical engineering department; calibration certificates were obtained and these were used routinely in care of other neonates. An adverse event reporting and resolution protocol for the wearable sensor devices to capture number and severity of adverse events; individual clinical management and feedback for changes into device design. Adverse events recorded were: dermatitis, infection, thermal injury, radiation injury, device leak/burst and others.
15780622|NCT04608552|Behavioral|OMT Exercises|Oral and oropharyngeal exercises
15780624|NCT04608552|Other|Use of Nasal Lavage|Use of nasal lavage with application of 10ml of saline in each nostril two times per day
15780625|NCT04608539|Drug|Ferric Derisomaltose|Single-dose intravenous infusion, 20 mg/kg body weight, postoperative day 1
15780626|NCT04608539|Drug|Ferrous sulfate|Oral therapy, 100 mg twice daily, from postoperative day 4 until 4-week follow-up
15780627|NCT04608539|Drug|normal saline|Single-dose infusion (placebo), postoperative day 1
15780628|NCT04608526|Diagnostic Test|Fractal analysis|Fractal dimension (FD) analysis, which can be measured in panoramic radiographs, is a technique that can be used to measure mandibular trabecular architecture and to determine early periodontal changes in alveolar bone. Fractal analysis method, which has become more and more popular in recent years; has features such as being easily accessible, not being affected by variables such as projection geometry and radiological density and providing objective data about trabecular structures. It can be measured in the patients' existing panoramic images and does not require extra imaging and material.
15780629|NCT04608513|Drug|ACT-1014-6470|Soft capsules for oral administration
15780630|NCT04608513|Drug|Placebo|Soft capsules for oral administration
15780631|NCT04608500|Drug|FMX103 minocycline foam 1.5%|Dosage form description: Foam containing minocycline HCl 1.5%. Once daily application of a sufficient amount of foam to cover the entire face. Estimated maximum is 0.5 g of drug product containing 7.5 mg (1.5% active) of minocycline. Participants will apply a small amount of the drug as a thin layer over all areas of the face. Participants should apply the drug at approximately the same time each day, about 1 hour before bedtime.
15780632|NCT04608500|Drug|Vehicle foam|Dosage form description: Foam containing minocycline vehicle foam. Once daily application of a sufficient amount of foam to cover the entire face. Estimated maximum is 0.5 g of drug product containing 0.0 mg (vehicle) of minocycline. Participants will apply a small amount of the drug as a thin layer over all areas of the face. Participants should apply the drug at approximately the same time each day, about 1 hour before bedtime.
15780633|NCT04608487|Drug|Fludarabine|Intravenous infusion
15780634|NCT04608487|Drug|Cyclophosphamide|Intravenous infusion
15780635|NCT04608487|Biological|Axicabtagene Ciloleucel|Intravenous infusion
15780636|NCT04608474|Drug|Evolocumab|Two different but equivalent drug dosing strategies are available. A 420mg monthly subcutaneous injection using an on-body infuser (Repatha Pushtronex system) or a 140mg subcutaneous injection once every two weeks using a prefilled auto-injector (Repatha SureClick). The choice of dosing strategy will be based on patient preference.
15780637|NCT04608474|Drug|Statins (Cardiovascular Agents)|Previously prescribed statin therapy.
15780638|NCT04608461|Drug|Pumpkin seed extract containing cream|Pumpkin seeds extract, white wax, white petrolium, stearyl alcohol
15780639|NCT04608448|Drug|Rapamycin Topical Ointment|8% topical rapamycin ointment
15780640|NCT04608448|Other|Placebo|Petrolatum ointment containing no active ingredient
15780641|NCT04608435|Other|Video-Assisted Thoracoscopic Surgery|patients receive Video-Assisted Thoracoscopic Surgery under general anesthesia
15780642|NCT04608422|Other|Electrical stimulation|A protocol of neuromuscular electrical stimulation will be applied on the quadriceps muscle (symmetric biphasic pulsed current, 80 Hz, 400 µs, 10 s contraction time, 50s/30s/20s rest time, the reciprocal mode, 20 min. After, a protocol of sensory stimulation will be applied on the anatomical region of the kidneys (First: 50 pps, 300 µs, continuous mode for 5 min; Second: 30 pps, 100 µs, continuous mode for 10 min; Third: 20 pps, 1000 µs for 30 min).
15780643|NCT04608409|Drug|Lapatinib and Paclitaxel|Participants will receive twice-daily Lapatinib, beginning two days prior to Paclitaxel treatment.
15780644|NCT04608396|Drug|AXS-05|AXS-05 taken daily for up to 52 weeks, until relapse.
15780645|NCT04608396|Drug|Placebo|Placebo taken daily for up to 52 weeks, until relapse.
15780646|NCT04608383|Other|Additional and minimal collection of products of the human body carried out during a sample for standard of care|"Swab of the peritoneal fluid for traces of COVID19. The collection of peritoneal fluid is a standard care practice.
~Swab from the laparoscopy filter"
15780647|NCT04608370|Behavioral|Active tPBM session|In this project, taking the method of random, double blindness and control, participants in the active tPBM group will take active tPBM session. After that, N-back tests and neuroimaging biomarkers will be compared between active tPBM group and sham tPBM group.
15780648|NCT04608370|Behavioral|Sham tPBM session|In this project, taking the method of random, double blindness and control, participants in the sham tPBM group will take sham tPBM session. After that, N-back tests and neuroimaging biomarkers will be compared between active tPBM group and sham tPBM group.
15780649|NCT04608357|Diagnostic Test|Needle Core Biopsies|Not an interventional study
15780650|NCT04608344|Drug|Atorvastatin|Administered as single dose tablet orally.
15780651|NCT04608344|Drug|Pravastatin|Administered as single dose tablet orally.
15780652|NCT04608344|Drug|Rosuvastatin|Administered as single dose tablet orally.
15780653|NCT04608344|Drug|Filgotinib|Administered as tablet orally once daily for 11 days.
15780654|NCT04608331|Drug|Dexmedetomidine|Patient-controlled analgesia is provided for at least 24 hours but no more than 48 hours. The pump is established with morphine (0.5 mg/ml) and dexmedetomidine (1.25 microgram/ml), in a total volume of 160 ml normal saline, and programmed to deliver 2-ml boluses at 6 to 8-minute lockout intervals with a background infusion rate of 1 ml/h.
15780655|NCT04608331|Drug|Placebo|Patient-controlled analgesia is provided for at least 24 hours but no more than 48 hours. The pump is established with morphine (0.5 mg/ml), in a total volume of 160 ml normal saline, and programmed to deliver 2-ml boluses at 6 to 8-minute lockout intervals with a background infusion rate of 1 ml/h.
15780656|NCT04608318|Biological|Ibrutinib|Cycles 1 - X: 420 mg daily, d1-28 p.o.
15780657|NCT04608318|Biological|Venetoclax|"Arm VG
~Cycle 1: 20 mg (2 tabl. at 10 mg), d22-28 p.o.
~Cycle 2: 50 mg (1 tabl. at 50 mg), d1-7; 100 mg (1 tabl. at 100 mg), d8-14; 200 mg (2 tabl. at 100 mg), d15-21; 400 mg (4 tabl. at 100 mg), d22-28 p.o.
~Cycles 3-12: 400 mg (4 tabl. at 100 mg), d1-28 p.o.
~Arm VI
~Cycle 4: 20 mg (2 tabl. at 10 mg), d1-7; 50 mg (1 tabl. at 50 mg), d8-14; 100 mg (1 tabl. at 100 mg), d15-21; 200 mg (2 tabl. at 100 mg), d22-28 p.o.
~Cycles 5-15: 400 mg (4 tabl. at 100 mg), d1-28 p.o."
15780658|NCT04608318|Biological|Obinutuzumab|Cycle 1: (100 mg, d1 + 900 mg, d2) or 1000 mg, d1; 1000 mg, d8 + d15 i.v. Cycle 2 - 6: 1000 mg, d1 i.v.
15780659|NCT04608305|Biological|IIBR-100, low dose (prime)|Single administration of IIBR-100 1*10E5 pfu/ml
15780662|NCT04608305|Biological|IIBR-100 low-dose (prime-boost)|Two administrations of IIBR-100 1*10E5 pfu/ml, 28 days apart
15780663|NCT04608305|Other|Saline Placebo (single)|Single administration of saline placebo
15780664|NCT04608305|Other|Saline Placebo (double)|Two administrations of saline placebo, 28 days apart
15780665|NCT04608305|Biological|IIBR-100 medium-dose (prime-boost)|Two administrations of IIBR-100 1*10E6 pfu/ml, 28 days apart
15780666|NCT04608305|Biological|IIBR-100 high-dose (prime-boost)|Two administrations of IIBR-100 1*10E7 pfu/ml, 28 days apart
15780667|NCT04608305|Biological|IIBR-100 top-dose (prime-boost)|Two administrations of IIBR-100 1*10E8 pfu/ml, 28 days apart
15780668|NCT04608292|Diagnostic Test|Single-voxel MRS|Diagnostic test is a single voxel MRS scan
15780669|NCT04608292|Diagnostic Test|Multi-voxel MRSI|Diagnostic test is a multi-voxel MRS imaging scan
15780670|NCT04608292|Diagnostic Test|Magnetization Transfer Imaging|Diagnostic test is a set of magnetic transfer weighted images
15780671|NCT04608292|Other|Alcohol ingestion|Participants will ingest an ethanol-containing beverage of approximately 0.5g/kg of ethanol mixed in 355 mL of a non-caffeinated, sugar-free carbonated drink which must be consumed in 5 minutes
15780672|NCT04608292|Device|ClearMate|Participants will breathe through the ClearMate, an MR-compatible non-rebreathing circuit which provides oxygen and carbon dioxide that quickly decreases a person's blood alcohol level.
15780673|NCT04608292|Diagnostic Test|Blood sampling|Participants will have a peripheral arterial and peripheral venous line inserted and periodic arterial and venous blood samples will be measured for blood alcohol content.
15780674|NCT04608266|Drug|Camostat Mesylate|Camostat mesylate, oral administration 600mg/day (2 x 100mg tablets every 8 hours) for 14 days
15780675|NCT04608266|Drug|Placebo|Placebo tablets, oral administration 2 tablets every 8 hours for 14 days
15780676|NCT04608253|Diagnostic Test|11C-choline PET/CT|11C-choline PET/CT
15780677|NCT04608227|Device|Clearsight monitoring|Non invasive hemodynamic monitoring using a finger cuff Cardiac ultrasound performed to calculate Velocity - Time - integral (VTI) Both intervention are performed before and after a passive leg raising challenge.
15780678|NCT04608214|Drug|Alisporivir|Administration of alisporivir at the dose of 600 mg p.o. BID from D1 to D14 to patients and standard of care (SOC).
15780679|NCT04608214|Other|Standard of care (SOC)|Locally accepted regimen protocols for patient care and select agents based on the underlying diagnosis and the severity of COVID 19 (excepting e.g. azithromycin and other antibiotics listed as prohibited medications)
15780680|NCT04608201|Drug|Nicotine 7 mg/ 24h Transdermal Patch - 24 Hour|"Treatment involves escalating doses to the target dose of 14 mg / day
~/ Dose escalation:
~Level 1: 3.5 mg/day (1/2 patch) for 2 days (D1 and D2)
~Level 2: 7 mg/day (1 patch) for 2 days (D3 and D4)
~Level 3: 10.5 mg/day (1.5 patch) for 2 days (D5 and D6)
~Level 4: target dose = 14 mg/day (from D7 to discharge from hospital + 1 week or maximum 5 weeks after the start of treatment)
~/ Decrease in dose (1 week after exit from hospital or maximum 5 weeks after the start of treatment): Decrease of 3.5 mg (1/2 patch) per week (over 3 weeks maximum)"
15780681|NCT04608201|Drug|Placebo of NICOTINE Transdermal patch|Placebo of nicotine patch administered to the same administration schedule as in the experimental arm
15780682|NCT04608188|Behavioral|Summer Camp|The intervention camps will operate according to routine practice, with no assistance from the investigative team. The camps provide indoor and outdoor opportunities for children to be physically active each day, provide enrichment and academic programming, as well as provide breakfast, lunch, and snacks. All camp meals will adhere to the United States Department of Agriculture Summer Food Service Program nutrition guidelines. The camps employ 1 staff member for every 12 children - which is consistent with childcare regulations in the state of operation and operate daily (Mon-Fri) for 8 weeks during the summer. The camps open at 7am and close 6 pm daily.
15780683|NCT04608175|Other|Acupuncture|Treatment of disease by inserting needles along specific pathways or meridians. The placement varies with the disease being treated. It is sometimes used in conjunction with heat, moxibustion, acupressure, or electric stimulation.
15780684|NCT04608162|Other|Pulsed Electromagnetic Field (PEMF)|PEMF was administered to the whole body using a 1.8×0.6m mat
15780685|NCT04608162|Other|Exercise Program|Exercise program to facilitate bone health
15780686|NCT04608162|Other|Placebo PEMF|Patients received placebo PEMF
15780687|NCT04608149|Device|Carpediem System|Continuous renal replacement therapy
15780688|NCT04608136|Behavioral|Diet intervention|Volunteers will be instructed on dietary recommendation throughout the research program to achieve a stable daily energy intake.
15780689|NCT04608123|Other|none (observational study)|DBS
15780690|NCT04608110|Drug|ASTX030|In Cycle 1 (28 days per cycle), single dose oral azacitidine will be administered on day -3, followed by subcutaneous (SC) azacitidine on day 1, oral azacitidine and oral cedazuridine on day 2-7; in Cycle 2 and onward, oral azacitidine and oral cedazuridine will be administered on day 1-7
15780691|NCT04608097|Behavioral|Simple cognitive task intervention|"A memory cue followed by playing the computer game Tetris (on own smartphone) with mental rotation instructions for ca. 12 minutes."
15780692|NCT04608097|Behavioral|Attention Placebo|A memory cue followed by listening to a podcast (on own smartphone) for ca. 12 minutes.
15780693|NCT04608084|Biological|Autologous platelet rich plasma eye drops|Participant own blood is used for the preparation of Autologous platelet rich plasma eye drops
15780694|NCT04608071|Procedure|A modified method for blind bedside placement of post-pyloric feeding tube.|Modified post-pyloric feeding tube bedside catheterization as an optimized bedside blind post-pyloric tube placement, significantly shortened the time for passing pylorus without causing any severe adverse reactions.
15780695|NCT04608058|Behavioral|Digital storytelling training|"The digital content in this study is called Diabetes and Bumblebee. It features 35 minutes of animation that provides children with a brief description of the disease, its symptoms and complications, treatment methods, the type of insulin, how to preserve insulin, the importance of nutrition and exercise in treating diabetes as well as efficient communication and collaboration with parents and healthcare providers. Exciting and interactive animations were used to depict the daily life of a adolescence with diabetes."
15780696|NCT04608058|Behavioral|Routine training|The control group received the clinics' routine training include face to face class education.
15780698|NCT04608032|Other|[Eco-Sz] Ecological Cognitive training program for schizophrenia spectrum disorder|The first group will have [Eco-Sz] Ecological Cognitive training program for schizophrenia spectrum disorder
15780699|NCT04608032|Other|Recovery-Oriented Therapy|The second group will have [THoR] Recovery-Oriented Therapy
15780700|NCT04608019|Other|Immediate Antibiotics|increase airway clearance/start oral antibiotics right away
15780701|NCT04608019|Other|Tailored Treatment|increase airway clearance and start oral antibiotics later if symptoms get worse or do not get better
15780702|NCT04608006|Drug|Bupivacaine-fentanyl|Initial epidural bolus of 10 ml Bupivacaine 0.125% plus 50 mcg Fentanyl, followed by continuous infusion pf Bupivacaine 0.0625%™ plus 1mcg/dl Fentanyl
15780703|NCT04607993|Behavioral|Prone position ventilation technique|"Inform the children's family members of the purpose and method of prone position ventilation
~Assess the fixation of various catheters
~Suspend feeding before placing prone position
~Confirm the time to start prone position ventilation under the joint assessment of medical staff
~Place the child in a prone position with the participation of researchers, doctors and nursing staff, with the child's head tilted to one side to avoid damage to the eyes and nose due to compression, and the arms are bent upward to form a W . Bend both lower limbs downward to form an M shape, and use a soft pillow cushion to measure the knee joints to avoid compression
~The whole process ensures the smooth fixation of tracheal intubation and various catheters
~Proper sedation during prone position ventilation to achieve good human-machine synchronization
~At least 6-8 hours in prone position every day"
15780704|NCT04607980|Drug|ABP 654|Participants will receive SC injection of ABP 654.
15780705|NCT04607980|Drug|Ustekinumab|Participants will receive SC injection of ustekinumab.
15780706|NCT04607967|Device|High Flow Nasal Oxygen|"Study participants are suffering from an acute hypoxemic respiratory distress. They have to be treated with oxygen-therapy that could be administered using a conventional oxygen device (study group CO) or High Flow Nasal Oxygen (study group HNFO). During the first 30 minutes following patients admission, patients will be randomized to one of the two study groups. In both groups, the failure of the treatment will be evaluated by the need for a therapeutic escalation fours hours after the treatment initiation."
15780707|NCT04607954|Biological|Durvalumab|Given IV
15780708|NCT04607954|Drug|Topotecan Hydrochloride|Given IV
15780709|NCT04607941|Other|Questionnaires|Self-administered questionnaires
15780710|NCT04607941|Other|Phone interviews|A small amount of subjects will be selected at random for phone interviews.
15780711|NCT04607928|Drug|Pirfenidone|Comparing the effect of pirfenidone in avoiding establishing or progression of fibrosis induced after COVID19 infection
15780712|NCT04607928|Drug|Placebo|Comparing the effect of pirfenidone in avoiding establishing or progression of fibrosis induced after COVID19 infection
15780713|NCT04607915|Behavioral|Intervention for TECC Model|The Care Coordinator (CC) will provide brief coaching sessions (15 to 20 minutes) to each participant once per week for 8 weeks. Participants can identify topics for discussion and the CC and participant can decide if a video session via WebEx is required versus a phone call. Also, participants will be given peer support and will be indirectly monitored by a virtual care team of experts.
15780714|NCT04607902|Behavioral|Supportive Therapy SSI|Online, 30-minute self-administered program for youth
15780715|NCT04607902|Behavioral|Behavioral Activation SSI|Online, 30-minute self-administered program for youth
15780716|NCT04607902|Behavioral|Growth Mindset SSI|Online, 30-minute self-administered program for youth
15780718|NCT04607876|Other|Technological Facilitator|See Enhanced Intervention Arm for full description.
15780719|NCT04607876|Other|Standard of Care|Risk factor assessment in first degree relative subjects and implementation of an education program for the randomized participants and their primary care provider.
15780720|NCT04607863|Diagnostic Test|Case control|Is a case-control research
15780724|NCT04607837|Drug|Etrasimod|Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks of treatment
15780725|NCT04607837|Drug|Placebo|Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks of treatment
15780726|NCT04607824|Behavioral|Duchenne Muscular Dystrophy group|Assessment of heart rate variability at rest and during computational task in people with Duchenne muscular dystrophy
15780727|NCT04607824|Behavioral|Typical Development group|Assessment of heart rate variability at rest and during computational task in people with typical Development
15780728|NCT04607811|Behavioral|Gamification with social incentives|Participants will select a step goal that is 33%, 40%, or 50% above their baseline step value. Participants in this group will participate in a game with points and levels to help motivate participants to meet their daily step goal. Additionally, all participants will identify a support partner to receive weekly updates on their performance and offer positive encouragement to help the participant meet their step goal.
15780729|NCT04607798|Device|Radiofrequency and pulsed electro-magnetic fields treatment|Radiofrequency and pulsed electro-magnetic fields treatment of the vaginal canal to maintain an internal temperature of approximately 42 C for the proximal thermometer and 45 C for the mid and distal thermometers for 15 minutes.
15780730|NCT04607785|Drug|Miswak mouthwash group|Twice daily for seven days for two months
15780731|NCT04607785|Device|Chlorhexidine gluconate mouthwash|Twice daily for seven days for two months
15780732|NCT04607772|Drug|Selinexor|Dose: 40 mg (2 tablets of 20 mg), 60 mg (3 tablets of 20 mg), 80 mg (4 tablets of 20 mg)
15780733|NCT04607772|Drug|Rituximab|Dose: 375 mg/m^2
15780734|NCT04607772|Drug|Bendamustine|Dose: 90 mg/m^2
15780735|NCT04607772|Drug|Polatuzumab Vedotin|Dose: 1.8 mg/kg
15780736|NCT04607772|Drug|Ibrutinib|Dose: 420, 560 mg
15780737|NCT04607772|Drug|Lenalidomide|Dose: 20, 25 mg
15780738|NCT04607772|Drug|Tafasitamab|Dose: 12 mg/kg
15780739|NCT04607772|Drug|Venetoclax|Dose: 200, 400, 600, 800 mg
15780740|NCT04607772|Drug|Gemcitabine|Dose: 1000 mg/m^2
15780744|NCT04607733|Drug|Mirikizumab Prefilled Syringe|Administered SC by prefilled syringe
15780745|NCT04607733|Drug|Mirikizumab Autoinjector|Administered SC by autoinjector
15780746|NCT04607720|Procedure|artificial-EUS-FNA|The ultrasound endoscopists manually determined the region of interest (ROI) according to CH-EUS, and punctured 2 needles in the tumor area with a 22G needle, and each needle moved 15-20 times back and forth in the lesion. After puncture, insert the needle core, rinse the needle with 0.1ml sterile saline, and further apply air flushing to ensure that each tissue is sent to the slide.
15780747|NCT04607720|Procedure|AI-EUS-FNA|In the AI-assisted diagnosis system, the assisted targeting EUS-FNA unit is applied, and the ultrasound endoscopist selects the region of interest (ROI) according to the thermogram to perform targeted EUS-FNA puncture(2 needles in the same way).
15780748|NCT04607694|Radiation|Proton radiotherapy|Proton radiotherapy
15780749|NCT04607694|Radiation|Photon radiotherapy|Photon radiotherapy
15780750|NCT04607681|Behavioral|EDUCATION|WEB BASED EDUCATION
15780753|NCT04607655|Drug|GB1211|GB1211 is a galectin-3 inhibitor an orally available small molecule anti-fibrotic. It is administered orally twice a day.
15780754|NCT04607655|Drug|Placebo|Placebo is administered as inhalation once a day
15780755|NCT04607642|Drug|BMX-001|BMX-001 consists of a porphyrin ring with pyridyl groups attached at each of the four methane bridge carbons. The nitrogen in the pyridyl ring is at the 2 position and has a side chain consisting of six carbons with an ether linkage. A manganese atom is chelated into the porphyrin ring and is the active center of the molecule. This molecule is an enzymatic scavenger of free radical species operating at close to diffusion-limited rates.
15780756|NCT04607642|Radiation|Radiation Therapy|Treatment plan should include a continuous course of treatment delivered as single daily fractions of 2.0 to 2.1 Gy with a cumulative radiation dose between 60 Gy and 70 Gy. Planned radiation treatment volumes must include at least two oral mucosal sub-sites (buccal mucosa, retromolar trigone, floor of mouth, tongue, soft palate, hard palate) with a portion of each site receiving at least 50 Gy.
15780757|NCT04607642|Drug|Cisplatin|Cisplatin is an IV chemotherapeutic agent approved to treat head and neck cancers. Cisplatin will be administered per institution's standard of care practice. Common standard of care practice includes dosing cisplatin at 100mg/m2 IV q21 days starting on Day 1 of RT for 2-3 doses or dosing cisplatin at 40 mg/m2 IV each week of RT for 6-7 total doses. Cisplatin will be infused per institutional guidelines.
15780758|NCT04607642|Other|Placebo|The placebo to be used in this study is 0.9% Sodium Chloride Injection, USP.
15780759|NCT04607629|Biological|Genolar® + Symbicort®|The experimental drug dose and administration frequency were determined based on baseline IgE concentration (IU / ml) measured before treatment and current body weight (kg). Depending on the initial IgE concentration and body weight the recommended drug dose was from 75 to 600 mg once in 2 or 4 weeks. The experimental drug Genolar® and the reference drug Xolair® were administered subcutaneously for 26 weeks. Budesonide + formoterol inhalation (dosed powder for inhalation, each delivered dose contains 320 μg budesonide and formoterol fumarate dihydrate 9 μg)) 1 inhalation 2 times a day.
15780760|NCT04607629|Biological|Xolair® + Symbicort®|The experimental drug dose and administration frequency were determined based on baseline IgE concentration (IU / ml) measured before treatment and current body weight (kg). Depending on the initial IgE concentration and body weight the recommended drug dose was from 75 to 600 mg once in 2 or 4 weeks. The experimental drug Genolar® and the reference drug Xolair® were administered subcutaneously for 26 weeks. Budesonide + formoterol inhalation (dosed powder for inhalation, each delivered dose contains 320 μg budesonide and formoterol fumarate dihydrate 9 μg)) 1 inhalation 2 times a day.
15780761|NCT04607616|Behavioral|Baseline sessions TAU|TAU consists of sessions lasting around one/one and a half hour ; the consultant is practicing as usual. The interventions focus on child's behavior, parent infant relationship, with moments of play with the child, advices, informations about child development and Autism.
15780762|NCT04607616|Behavioral|Interactive guidance therapy|"The objective is to reinforce the identification, deciphering, interpretation, and answer to child's signals by the parent, in order to to promote a synchronous and attuned response to the child's needs.
~Sessions last around one/one and a half hour. Parent plays 7-10 minutes with the child, in the presence of the therapist, with toys chosen according to the child's developmental stage. Then therapist proposes an immediate viewing of the play session. The therapist selects short moments of positive interaction. He has determined a  focus , depending on the play, previous sessions, the child's difficulties and parent's interventions. He accompanies, guides and supports the parent to describe the interaction, the alternance in play, joint attention, shared affect, in a co-construction: the parent discovers the child's and his own skills."
15780763|NCT04607616|Diagnostic Test|Developmental and diagnostic assessments|MSEL, CARS, ECAR, CIM10, DMS5, ADOS, ADIR
15780764|NCT04607616|Behavioral|Developmental assessment -Parental scales|Vineland II, IFDC, IDE
15780765|NCT04607616|Behavioral|Qualitative analysis|Interpretative Phenomenological Analysis. Parents' semi structured interview about the Interactive Guidance experience. Qualitative analysis of transcripts (recurrent themes, meta themes).
15780766|NCT04607603|Drug|Cannabidiol Oral Product|Cannabidiol is administered in capsules. Each capsule contains 200mg of CBD administered 3 times daily to a total of 600mg per die
15780767|NCT04607603|Drug|Placebo|Placebo will be administered in capsules of identical appearance to CBD capsules in 3 doses per die
15780768|NCT04607590|Other|Best Practice|Receive usual care
15780769|NCT04607590|Procedure|Quality-of-Life Assessment|Ancillary studies
15780770|NCT04607590|Other|Questionnaire Administration|Ancillary studies
15780771|NCT04607590|Procedure|Yoga|Participate in yoga sessions
15780802|NCT04607356|Device|Blood Flow Restriction (BFR)|The Delphi Personalized Tourniquet System (PTS) will be utilized for the BFR exercises. The external constriction device will be applied to the proximal aspect of an individual's limb to restrict the flow of blood into and out of the extremity at 50% of usual flow. Subjects will perform a 30-15-15-15 repetition progression of 1-3 exercises as selected by the therapist. The Delphi PTS cuff is inflated at the start of the exercise and remains inflated throughout the exercise. Once the participant has completed an exercise, the cuff is deflated for 1 minute and the same cycle is performed for each subsequent exercise.
15780772|NCT04607564|Other|Ntombi Vimbela! intervention|Ntombi Vimbela! constitutes a series of ten workshops running for a total 35 hours. The intervention is designed to raise awareness about sexual rights, violence against women and girls and its drivers; sensitise about gender inequality and build more gender equitable beliefs; sensitise about sexual assault; equip participants with skills to assess and act in situations where there is a high risk of sexual assault; build resilience and skills to withstand social and material pressures in college or university ; enable utilisation of health, psycho-social services and access to justice for survivors; enhance communication skills and building healthy sexual relationships; promote mental health and coping and build empathy towards survivors.
15780773|NCT04607551|Procedure|Prone positionning|4 to 5 persons required for the procedure, one of them being dedicated to the management of the head of the patient, the endotracheal tube, the jugular ECMO cannula and the ventilator lines and another dedicated to the femoral ECMO cannula. The person at the head of the bed will coordinate the steps. The other persons will stand at each side of the bed. The direction of the rotation will be decided giving priority to the side of the central venous lines. The length of vascular and ventilator lines will be checked for appropriateness, the endotracheal tube and gastric tube will be secured, and the patient's knees, forehead, chest, and iliac crests will be protected using adhesive pads. The patient will be then moved along the horizontal plane to the opposite side of the bed selected for the direction of rotation. Patients will be proned at least four times during the first days on ECMO. Each prone session will stand for at least 16 hours
15780774|NCT04607551|Procedure|Supine position|Patients assigned to supine will remain in a semi-recumbent position.
15780776|NCT04607525|Drug|Dexmedetomidine|"On the scheduled time of operation, the head nurse opened each envelope just before surgery, prepared the infusion solution and handled it to the anesthesiologist who was blinded to the solution. He was then determined for collecting perioperative data.
~Group D: Patients received 0.5 µg/kg/h of Dexmedetomidine. Dexmedetomidine dosage was diluted in 50 ml syringe of normal saline Group C: Patients received equal volume and rate of normal saline as Group D.
~This dosing regimen was in accordance with existing guidelines [5] [6] [7]."
15780777|NCT04607525|Drug|normal saline|"On the scheduled time of operation, the head nurse opened each envelope just before surgery, prepared the infusion solution and handled it to the anesthesiologist who was blinded to the solution. He was then determined for collecting perioperative data.
~Group C: Patients received equal volume and rate of normal saline as Group D."
15780778|NCT04607512|Drug|telaglenastat|glutaminase inhibitor
15780779|NCT04607512|Other|telaglenastat placebo|matching placebo for telaglenastat
15780780|NCT04607512|Other|moxifloxicin|positive control
15780781|NCT04607486|Diagnostic Test|3DfUS and IPSA of leg muscles|"3DfUS technique enhances a conventional 2D US device into a platform capable of reconstructing 3D anatomical data sets.
~IPSA for quantification of hyper-resistance and its underlying components. The sensors in the IPSa include gyroscopes and accelerometers to measure joint angle and angular velocity, EMG to measure muscle activity, and a 3 degrees-of freedom force sensor to measure torque applied on the joint.
~clinical functional capacity = clinical evaluation of degree of independence, mobility and gait"
15780782|NCT04607473|Device|automated breast ultrasound (ABUS)|Both HHUS and ABUS will be performed on each patient for preoperative staging. Breast radiologists each independently will read HHUS and ABUS images obtained from one patient. The radiologists will be blinded to the findings of the other US mode.
15780783|NCT04607460|Device|JOGO Digital Therapeutics EMG Biofeedback|Use of the JOGO Digital Therapeutics EMG Biofeedback device for 8 weeks
15780784|NCT04607447|Behavioral|low intracranial pressure strategy treatment|"Supine position for 16h-18h daily, with head toward the affected side in most of the time, and 15-20 cm elevation of lower limbs.
~Abdominal belt compression"
15780785|NCT04607447|Drug|Atorvastatin plus Dexamethasone|Atorvastatin plus Dexamethasone
15780786|NCT04607434|Drug|Ocotillol Type Ginsenoside Derivatives|Peripheral blood PMN of healthy adults and peripheral blood PMN of patients with ARDS were taken. The neutrophils isolated from peripheral blood of ARDS patients and healthy control group were incubated with different doses of OCT glycine derivatives (20,50,100 UM) for 20 h
15780795|NCT04607408|Biological|CH505TF gp120|HIV-1 CH505 transmitted/founder virus Env gp120 immunogen
15780796|NCT04607408|Biological|GLA-SE adjuvant|An oil-in-water stable emulsion (SE) containing the immunological adjuvant Glucopyranosyl Lipid A (GLA)
15780797|NCT04607408|Biological|Placebo|Sodium Chloride for Injection, 0.9% USP
15780798|NCT04607395|Radiation|pre-operative radiograph|"Three hundred and sixty pre-operative radiographs of deep carious lesions and a contrasted version of the same set have been screened and annotated by 4 evaluators. Annotations were placed at the dentino-enamel junction, at the floor of the carious lesions, and on pulp chamber wall. From these annotations, the ratios residual dentin thickness/ total dentin thickness were derived. First, inter-evaluator agreement and concordance were assessed. A logistic regression that accounted for measurement error was applied to precisely estimate the capacity of the ratio to predict exposure (reported as odds-ratio)."
15780799|NCT04607382|Drug|LEP|LEP dosage up to the discretion of the treating gynecologists.
15780800|NCT04607382|Drug|NSAIDs and/or Chinese medicine (CM)|Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and Chinese medicine (CM) dosage up to the discretion of the treating gynecologists.
15780801|NCT04607369|Device|EyeQTester|Smartphone app that allows vision testing
15780803|NCT04607356|Other|Evidence-informed care|Evidence-based resistive exercises, stretches, soft tissue mobilization and patient education for lateral epicondylalgia.
15780804|NCT04607343|Device|Rehabilitation device based on electrical stimulation|Experimental tests with transcutaneous electrical stimulation at different intensities and at the points of the submandibular region previously explored will be conducted first of all on the five healthy volunteer subjects. During these tests, the neuromuscular thresholds of the upper airway, the most effective points of electrostimulation and the tolerance of intervention will be determined. The determination of the functional threshold will be made by clinical evaluation of the subject during stimulation.
15780805|NCT04607330|Other|High protein liquid|After a 1-day baseline period to establish patients' acceptability, gastrointestinal tolerance, compliance, dietary intake while also capturing information related to user experience, risk of malnutrition, physical function, dietary intake, anthropometry and safety with their currently prescribed nutritional regimen, each patient will receive the high protein liquid daily for 28 days where the same measures will be replicated. The amount of the high protein liquid prescribed will always be completed by the patients' managing dietitian.
15780806|NCT04607317|Behavioral|Exercise program|a telehealth-delivered exercise program with the goal of progressing to 150 min/week (5 days per week, 30 minutes of steady state walking per day)
15780807|NCT04607317|Behavioral|Health Coach|The coach will work directly with each participant during their once-weekly virtual 1:1 meeting to progress intensity and duration. Participants will meet with the coach to review a brief social cognitive theory-based module, which will provide education on core behavior change concepts and the benefits of physical activity for those with epilepsy. The coach will review the previous week's exercise during meetings, and will then work with the participant to revise and reset goals for the coming week.
15780808|NCT04607317|Behavioral|Health Information|Participants will be contacted by a study coordinator via telephone every 2 weeks for health education. During this time, they will review resources and healthy lifestyle guidelines for people with epilepsy, including healthy diet, medication compliance, seizure precautions, stress management, and sleep hygiene.
15780809|NCT04607304|Device|ABCA2 GIRMS|Two systems (ABCA-C and ABCA-D) with run order randomized
15780810|NCT04607291|Other|Community Health Service|Receive Witness CARES services
15780811|NCT04607291|Other|Survey Administration|Ancillary studies
15780812|NCT04607278|Dietary Supplement|Probiotic|Oral probiotic supplementation was provided by iHealth; Cromwell, USA. Each sachet included a 1×1010 CFUs dose of four viable microbial cell preparation strains: there are two strains of lactobacillus genus (Lactobacillus acidophillus L1 (2.9×109) and Lactobacillus rhamnosus liobif (2.9×109)), Bifidobacterium longum (2.9×109) and Saccharomyces boulardii (1.3×109). Each participant took a total daily dose of 4×1010 CFUs.
15780813|NCT04607278|Dietary Supplement|Prebiotic|The prebiotic was made up of inulin from the chicory plant and provided by the Fibrelle (Belgium) company. Five grams packs were given to the participants in boxes. Each participant was requested to take a total daily 10 g dose.
15780814|NCT04607278|Dietary Supplement|Placebo|It was composed of maltodextrin, and provided by the manufacturer Fibrelle; (Belgium). The prescription was similar to probiotics or prebiotics groups.
15780815|NCT04607265|Diagnostic Test|Cardiac MRI|Comparison of scar characteristics on cardiac MRI between the two groups.
15780816|NCT04607252|Drug|Metformin plus Megestrol acetate|metformin 1500mg, per day, oral; megestrol acetate 160mg per day, oral
15780817|NCT04607252|Drug|Megestrol Acetate|megestrol acetate 160mg per day, oral
15780818|NCT04607239|Procedure|Telemonitoring|"A weekly telephone call by the CRA for the collection of home blood pressure measurements (which the patient measures twice a day everyday), for therapeutic education, and for treatment compliance assessment.
~A monthly call by the attending physician for treatment titration and side effects check."
15780819|NCT04607239|Procedure|Usual Care without Telemonitoring|"Attending the follow up visits after inclusion at Day 90 (D-90) & Day 180 (D-180) for face to face consultation with the attending physician.
~Usual care without any phone calls for therapeutic education, treatment compliance assessment, treatment titration or side effects check."
15780820|NCT04607226|Other|Active transcutaneous vagus nerve stimulation|respiratory-gated non-painful electrical stimulation of the auricle for 30 minutes
15780821|NCT04607226|Other|Sham transcutaneous vagus nerve stimulation|stimulation of the auricle for 30 minutes
15780822|NCT04607213|Procedure|Advancement-rotation approach based on Millard' for repairing lip defect.|"patients were treated using Millard technique is the downward rotation of the medial part of the flap, and lateral advancement of the flap to close and fill the defect. if more lip height is needed; cut- as- you-go by adding a back-cut incision at the end of his rotation incision down toward the philtral ridge of non-clefted side. Moreover; C-flap is used to close nasal sill."
15780823|NCT04607213|Procedure|Straight-line approach|"patients were treated using Straight-Line design based on Fisher modification. C-shaped flap extend from the proposed nasal sill to the origin of philtral column of medial flap as a straight incision to the planned top of the cupid's bow. In addition, to the previous mentioned incision, small inlate incision is needed to length the cleft side on the medial flap.
~On the other hand, on the lateral flap; two connected triangular incisions are used; one on the vermillion border at Noordhoff's point. And the other one just above the cutaneous margin to improve aesthetic outcome and diminish formed scar."
15780824|NCT04607200|Drug|AGEN2034|Anti-PD-1 Monoclonal Antibody
15780825|NCT04607200|Drug|AGEN1884|Anti-CTLA-4 Monoclonal Antibody
15780826|NCT04607174|Other|Pathologic group|"Voluntary Activation level will be determined according to the interpolate twitch technique (ITT).
~During isometric contractions (knee at 40° flexion), three electric shocks (doublets) will be delivered. The first shock will be delivered at rest before contraction. The second one will be delivered 3-4 s after the beginning of the effort. The third one will be delivered at rest 2-3 s after the contraction has ended. Two isometric contractions will be performed, with a 3-minute break.
~Then, 3 consecutive continuous passive motion (CPM) extension-flexions of the knee joint (range 105-0°), and 3 isokinetic concentric contractions (ISOK) will be performed. During both CPM and ISOK an electric shock will be delivered during each repetition. The instant of stimulation will be determined in a way allowing the twitch moments to peak at exactly 40° of knee flexion during extension. The same procedure will be administered first to the affected limb, and then to the non-affected limb."
15780827|NCT04607161|Other|no intervention|no intervention
15780828|NCT04607148|Drug|RG6147|Intravitreal (ITV) injections of RG6147.
15780911|NCT04606394|Drug|Ventolin 90Mcg/Actuation Inhalation Aerosol|2 hours after the administration of Trelegy, administer Ventolin in all patients
15780829|NCT04607135|Device|Acoustic radiation force impulse (ARFI)|"Sound waves are sent in a series and are expected to push on the prostate and move it a very small amount (the width of a hair). The stiffer the structure (prostate), the less it will move. This motion will be detected by the ultrasound system"
15780830|NCT04607135|Device|Ultrasound|Standard ultrasound imaging session, ultrasound sound waves are sent into the tissue and bounce off of structures to make an image that appears on a screen
15780831|NCT04607122|Drug|Landiolol|Continuous infusion of landiolol starting at 1 µg/kg/min and increasing every 10-15 minutes with incremental doses of 0.5 µg/kg/min up to 2 µg/kg/min by maintaining MAP ≥ 65 mmHg and HR ≥ 50/min.
15780832|NCT04607122|Drug|Saline|Continuous infusion of saline solution at the same rate as landiolol infusion.
15780833|NCT04607096|Behavioral|Intermittent fasting|The intermittent fasting intervention consists of a decreased daily caloric intake of 400 kcal below individual requirements (Harris Benedict Formula) combined with early time restricted fasting according to the schema 16:8. fasting will be performed over 4 weeks.
15780834|NCT04607096|Behavioral|Control diet|Control group will be advised to reduce daily caloric intake of 400 kcal below individual requirements (Harris Benedict formula)
15780835|NCT04607083|Diagnostic Test|Polyp carachterization by combing endoscopist evaluation and Ai output|A polyp characterization (adenoma vs. non adenoma) is provided by endoscopist in light of the results of this own evaluation and of the Ai system output. The confidence level (high vs. low) in polyp characterization is recorded. The combined evaluation is compared with histopathology results.
15780836|NCT04607057|Drug|Parenteral Nutrition Solutions|"Day0 : fasting(NPO) + crystalloid fluid
~POD#1 : Keep fasting, then start sips of water in the evening + crystalloid fluid
~POD#2 : Semifluid diet (SFD) + crystalloid fluid
~POD#3 : Semifluid diet (SFD) + PN
~POD#4-7: Soft blended diet (SBD) + PN"
15780837|NCT04607044|Device|SALVATION™ EXTERNAL FIXATION|Wright Medical's lower extremity devices used to treat neuropathic patients
15780838|NCT04607031|Diagnostic Test|measurement of serum ST2 concentrations in serum of patients with acute, ischemic stroke|7 measurements of serum ST2 concentrations from day 0 to day 6, modified Rankin scale before, 6th and 90th day, NIHSS from day 0 to day 6 and 90, TOAST and OCSP classifications
15780839|NCT04607018|Device|PMA-zeolite|"subjects received boxes containing PMA-zeolite powder for supplementation for a total of 28 days.
~Dosage for PMA-zeolite (100% zeolite; 1 ML - spoon for dosage = ca. 3 g zeolite):1 spoon of the powder stirred 2 times daily (morning and evening) in water (1 glass)."
15780840|NCT04607005|Drug|Mepolizumab|Mepolizumab will be available as a clear to opalescent, colorless solution for SC injection in a single-use, safety syringe at a unit dose strength of 100 mg/milliliters (mL).
15780841|NCT04607005|Drug|Placebo|Placebo will be available as a clear to opalescent, colorless sterile solution for SC injection in a single-use, safety syringe
15780842|NCT04607005|Drug|Standard of care|Participants will continue to receive Standard of care as they are used to before entry in the study.
15780843|NCT04606992|Procedure|CELS|CELS resection for early colon cancer is a compromised resection performed in frail patients
15780844|NCT04606979|Device|1x1 Low Intensity Transcranial Direct Current Stimulation (tDCS)|"tDCS will be delivered through a pair of identical square rubber electrodes (size 35 cm2), placed in rectangular saline-soaked sponges. For the stimulation of M1, electrodes will be placed over C3 or C4 according to the 10-20 EEG system, matching with the M1 contralateral to the performing dominant hand. The reference electrode will be positioned on F1 or F2, ipsilateral to the dominant hand.
~The current stimulation will be slowly ramped up from 0 mA to 2 mA in one minute. For the anodal tDCS condition, this intensity will be maintained for the duration of the SRT-task (approximately 20 minutes). This will result in a current density of 0,057 mA/cm2. For the sham tDCS condition - unbeknown to the subject - stimulation will be gradually decreased towards 0 mA immediately after the one-minute ramp-up. During the last block of the SRT-task, this gradual ramping-up and -down of the current stimulation will be repeated to optimize the process of blinding of participants."
15780845|NCT04606966|Other|Therapeutic Horseback Riding|Horse therapy
15780846|NCT04606966|Other|Barn Activity|Horsemanship group
15780847|NCT04606966|Other|Hybrid|Ground and riding activities
15780848|NCT04606953|Behavioral|Attention Process Training (APT-II)|The exercises target different attentional components and working memory in the auditory-visual modalities. They are of increasing difficulty while being adapted to the profile of each patient in order to maximize the effects on cognitive reserve. During the sessions, the emphasis is on generalizing the gains to the most problematic daily activities in order to reduce the impact of cognitive disorders in patients' daily life.
15780849|NCT04606927|Other|Natriuresis|Patients with insufficient decongestive response based on natriuresis (in the active arm) will be eligible for treatment adjustments according to the natriuresis guided treatment algorithm.
15780850|NCT04606914|Drug|mirvetuximab soravtansine (MIRV; IMGN853)|Mirvetuximab soravtansine (also known as IMGN853 and MIRV) is an antibody-drug conjugate (ADC) that consists of a high affinity humanized monoclonal antibody against folate receptor α (FRα, the protein product of the folate receptor 1 [FOLR1] gene) that is conjugated to a cytotoxic maytansinoid by the hindered disulfide succinimidyl 4-(pyridin-2-yl)disulfanyl)-2-sulfo-butyrate linker (sulfo-SPDB) linker. FRα is a glycosyl-phosphatidylinositol (GPI)-linked protein, which shows limited normal tissue expression and high expression on the surface of solid tumors, particularly epithelial ovarian cancer, fallopian tube cancer, and primary peritoneal cancer (referenced herein collectively as EOC), endometrial cancer, non-small cell lung cancer (NSCLC), and renal cell cancer.
15780851|NCT04606901|Drug|neostigmine/glycopyrrolate|neuromuscular blockade reversal agents
15780852|NCT04606901|Drug|sugammadex|neuromuscular blockade reversal agent
15780853|NCT04606888|Device|Transcutaneous electrical acupoint stimulation|According to the traditional Chinese medicine 15,three acupuncture points were selected as the target points: bilateral Neiguan ,Yintang and bilateral Zusanli.. A transcutaneous electrical stimulator was used to provide an altered frequency 2/100 Hz,disperse-dense waves,and adjusted intensity which was less than 10mA.
15780854|NCT04606875|Diagnostic Test|Campbell Score|The Campbell Score is a blood based assessment of inflammatory and immunologically associated markers that is currently in development as a means of predicting suicidal ideations.
15780912|NCT04606381|Drug|Ami-LC-MD|Participants will receive amivantamab admixed with rHuPH20 SC infusion.
15780913|NCT04606381|Drug|Ami-LC|Participants will receive amivantamab SC infusion.
15780855|NCT04606862|Device|Morley Medical Sepsis Software Device|The Morley Medical Sepsis (MMS) Software Device is a predictive analytics, stand-alone, cloud-based software system with no hardware components. The software acquires patient data from the electronic medical record, processes the data using unique artificial intelligence (AI) powered algorithms, and generates clinical decision support outputs that aid in the proactive delivery of customized and efficient care for patients. The software output is made available to the end users (trained medical professionals) via an intuitive user interface displayed on desktop computers or mobile communication devices such as laptops, smartphones or tablets.
15780856|NCT04606849|Other|Physician Survey|Our questionnaire includes questions on respondent demographics and Likert-style questions about respondent experiences with ePNa. We will validate our modified questionnaire by calculating component loadings and Cronbach Alphas (i.e., internal consistency) of Likert questions loading onto the same components.
15780857|NCT04606849|Device|ePNa-CheXED|ePNa-CheXED will incorporate Stanford University's artificial intelligence CheXED model to provide electronic classification of chest images in <1 second for elements of pneumonia diagnosis and treatment (radiographic pneumonia, single vs multiple lobes, and pleural effusion).
15780858|NCT04606836|Drug|Bupivacaine Hydrochloride|See group descriptions
15780862|NCT04606810|Other|multidisciplinary educational intervention|At randomization, participants in arm 1 received the educational DVD with the instruction to review its contents within the next two weeks. Between 2 and 4 weeks after randomization, reinforcement teleconferences were done in small groups of 10 participants maximum per session with every participant who mentioned having watched the DVD. Each participant attended only to one teleconference. Usual care consisted in regular follow-up with the treating rheumatologist and possibility of asking questions of the rheumatology nurse by phone.
15780863|NCT04606797|Drug|Nicotine patch|Nicotine transdermal patches as per product monograph
15780864|NCT04606784|Biological|Ampion|Ampion, nebulized for inhalation
15780865|NCT04606784|Other|Standard of Care|Standard of Care
15780866|NCT04606771|Drug|Osimertinib + Savolitinib|"Osimertinib 80 mg oral QD
~Savolitinib 300mg oral QD"
15780867|NCT04606771|Drug|Savolitinib + Placebo|"Savolitinib 300mg Oral QD
~Placebo to Osimertinib 80mg oral QD"
15780868|NCT04606758|Procedure|PCNL under fluoroscopic control|Patients receive standard of care treatment for their urolithiasis using standard PCNL under fluoroscopic guidance
15780869|NCT04606758|Procedure|PCNL under ultrasound control|Patients receive standard of care treatment for their urolithiasis using standard PCNL under US guidance
15780870|NCT04606719|Procedure|Advanced Platelet Rich fibrin|Preparing of A-PRF by drawing 5 mL of venous blood from the patient in dried glass test tube and immediately centrifuging it at 1500 rpm for 14 minutes
15780871|NCT04606706|Other|Mobile health nutrition education intervention|Nutrition education will be given through mobile phone
15780872|NCT04606693|Other|Treatment of SAHS|Patients diagnosed with SAHS will be treated in the Pneumology Service according to usual practice (dietary hygienic measures, CPAP, etc.).
15780873|NCT04606680|Device|Heat application at acupoints|"The acupoints will be selected as Tianshu, Pishu, shenshu, zhongwan, and zusanli. The location of the acupoints were based on the national GB/T 12346-2006 acupoints standard. The hot sticker will be placed on the patient's acupoints for about 2 hours. This treatment will be applied once every other day, 3 times per week, for 4 consecutive weeks. The treatment will be delayed during the menstrual period.
~The following lifestyle modification are recommended to help to establish healthy habits:
~The proportion of three nutrients in total calories comprises of 55%-65% from carbohydrates, 20%-30% from oils and 15% from protein, and the energy of the whole day distributed to three meals will follow the proportion of 30% for breakfast, 40% for lunch and 30% for dinner. Meanwhile, low-to-moderate intensity physical activities will be instructed to them for at least 5 days per week continually, 30%-50% of the maximum heart rate reserve value will be required."
15780874|NCT04606680|Device|Medicated plaster at acupoints|"The acupoints will be selected as Tianshu, Pishu, shenshu, zhongwan, and zusanli. The location of the acupoints were based on the national GB/T 12346-2006 acupoints standard.The chinese traditional medicine(aconite root, dried ginger, evodia rutaecarpa, clove, cinnamon, etc)in moderation will be grinded into powder，and the powder will be added with a certain amount of flour, and finally they will be blended with ginger juice to the appearance of mud. Next, 10g of the kneaded medicine mud will be taked and applied to the bottom of the ordinary sticker. They will be placed on the patient's acupoints for about 2 hours. The sticker has the same shape as the hot sticker, but it does not have the effect of thermal stimulation and infrared radiation. This treatment will be applied once every other day, 3 times per week, for 4 consecutive weeks. The treatment will be delayed during the menstrual period.
~Lifestyle modification:It will be performed as the same as the heat application group."
15780875|NCT04606680|Device|Herb-partitioned moxibustion at acupoints|"The acupoints will be selected as Tianshu, Pishu, shenshu, zhongwan, and zusanli. The location of the acupoints were based on the national GB/T 12346-2006 acupoints standard[18]. The chinese traditional medicine(aconite root, dried ginger, evodia rutaecarpa, clove, cinnamon, etc)in moderation will be grinded into powder，and the powder will be added with a certain amount of flour, and finally they will be blended with ginger juice to the appearance of mud. Next, 10g of the kneaded medicine mud will be taked and applied to the bottom of the hot sticker. They will be placed on the patient's acupoints for about 2 hours. This treatment will be applied once every other day, 3 times per week, for 4 consecutive weeks. The treatment will be delayed during the menstrual period.
~Lifestyle modification:It will be performed as the same as the heat application group."
15780876|NCT04606667|Other|Exercise Program|Exercise program
15780914|NCT04606381|Drug|Ami-HC|Participants will receive amivantamab newly developed high concentration SC infusion.
15780915|NCT04606381|Drug|Ami-HC-CF|Participants will receive amivantamab co-formulated with rHuPH20.
15780916|NCT04606368|Device|Thermage FLX|Monopolar radiofrequency will be applied through the Thermage FLX machine to the subject's right lower jaw and submentum area.
15780877|NCT04606654|Other|Handgrip strength training without Blood flow restriction|Participants of this group will get exercise training through hand grip strengthener and DMOOSE fitness resistance bar. Participants will contract his/her forearm at a rate of 15 times/min (1 contraction every 4 sec). The subjects will train for 20 min, 3 days per week for 2 weeks (total 6 sessions), under the supervision of a principle investigator. Participants will be allowed to take 1 min rest periods, after the completion of 5 minutes of training.
15780878|NCT04606654|Other|Handgrip strength training with Blood flow restriction|Participants of this group will get exercise training through hand grip strengthener and DMOOSE fitness resistance bar. Participants will contracts his/her forearm at a rate of 15 times/min (1 contraction every 4 sec). The subjects will train for 20 min, 3 days per week for 2 weeks (total 6 sessions), under the supervision of a principle investigator. Participants will be allowed to take 1 min rest periods, after the completion of 5 minutes of training. However, for one of the limbs the pneumatic blood pressure cuff will be placed on the upper arm, 4 cm proximal to the ante-cubital fossa. The decision which arm would receive the occlusion during training will be randomized to avoid a dominant or non-dominant hand bias. During experimental group training blood pressure cuff will be partially inflated (80 mmHg) to ensure venous occlusion. Participants will be allowed to take 1 min rest periods, after the completion of 5 minutes of training while the cuff remained inflated.
15780879|NCT04606641|Other|functional tasks with mirror therapy|In this group a mirror will be placed in the sagittal plane of patient. The affected or paretic arm will be placed behind the mirror and the unaffected or normal arm will be placed in front of the mirror. Then the patient will be asked to perform functional tasks
15780880|NCT04606641|Other|functional tasks without mirror therapy|The functional tasks will be explained to patient before the start of treatment. In this group a board instead of a mirror will be placed in the sagittal plane of patient. Then the patient will be asked to perform functional tasks
15780881|NCT04606628|Other|Eggshell membrane (ESM)|The intervention group will consume two capsules containing (in total) 500mg ESM with breakfast every day in 4 weeks.
15780882|NCT04606628|Other|Placebo|The placebo group will consume two placebo capsules (Cellulose) with breakfast every day in 4 weeks
15780883|NCT04606602|Drug|SLN360|SLN360 for subcutaneous (s.c.) injection
15780884|NCT04606602|Drug|Placebo|Sodium chloride for subcutaneous (s.c.) injection
15780885|NCT04606589|Device|neoGuard vital signs monitor|The neoGuardTM device is a 4-in-1 wearable vital signs monitor designed to continuously measure temperature, pulse rate, respiratory rate and blood oxygen saturation in newborns.
15780886|NCT04606576|Other|Placebo|Fish Oil
15780887|NCT04606576|Drug|ORMD-0801 QD|Oral Insulin once per day
15780888|NCT04606576|Drug|ORMD-0801 BD|Oral Insulin, twice per day
15780889|NCT04606563|Drug|Losartan|Oral losartan 25 mg, stepped up to 50 mg and then up to 100 mg peak dose, as tolerated.
15780890|NCT04606550|Device|Microablative Fractional CO2 Laser Therapy|Microablative Fractional CO2 Vaginal Laser Therapy
15780891|NCT04606537|Drug|Itraconazole|200 mg itraconazole, given orally as 20 mL × 10-mg/mL solution BID on Day 15, followed by QD dosing on Days 16 through 23, inclusive.
15780892|NCT04606537|Drug|Rifampin|600 mg rifampin, given orally as 2 × 300-mg capsules QD on Days 15 through 25, inclusive.
15780893|NCT04606537|Drug|KBP-5074|0.5 mg KBP-5074, given orally as 1 × 0.5-mg tablet on Days 1 and 19 or Days 1 and 21
15780894|NCT04606511|Diagnostic Test|Circumference tape measurements|centimeter and volume criterias
15780895|NCT04606511|Diagnostic Test|Indocyanine green lymphangiography|Presence of dermal backflow
15780896|NCT04606511|Diagnostic Test|bioimpedance spectroscopy|7.5 and 10 L-DEX criterias
15780897|NCT04606511|Diagnostic Test|Symptom score|using lymph-icf, DASH and SF-36 questionnaires
15780898|NCT04606498|Other|Observational|Observational study only - no intervention
15780899|NCT04606485|Other|Acupressure|Acupressure is accepted as a non-invasive application that can easily be applied by trained nurses, which increases the quality of the medical care administered and contributes to physical and psychological recovery.
15780900|NCT04606472|Drug|SI-B003|Administration by intravenous infusion.
15780901|NCT04606459|Device|Coronary sinus reducer|The Reducer System comprises the Reducer device (Reducer) pre-mounted on the Reducer Balloon Catheter. The Reducer System is available in one model size. The Reducer is a sterile, single-use, implantable device designed to establish a narrowing in the coronary sinus (CS) and is intended to improve perfusion to ischemic myocardium in the presence of reversible ischemic heart disease to alleviate the symptoms of refractory angina. The device is implanted percutaneously through the right internal jugular vein into the CS. The Reducer is pre-mounted (crimped) on the Reducer Balloon Catheter which, after inflation, causes device expansion and apposition with the vessel wall. The balloon catheter is then deflated and removed from the CS, leaving the device permanently implanted.
15780902|NCT04606459|Other|Optimal medical therapy|Guideline-directed medical therapy
15780903|NCT04606446|Drug|PF-07248144|KAT6 Inhibitor
15780904|NCT04606446|Drug|Fulvestrant|Endocrine Therapy
15780905|NCT04606446|Drug|Letrozole|Endocrine Therapy
15780906|NCT04606446|Drug|Palbociclib|CDK4/6 Inhibitor
15780907|NCT04606433|Drug|GNC-038|Administration by intravenous infusion.
15780908|NCT04606420|Behavioral|Lifestyle medicine|"Diet: A low fat (10-15%) whole foods vegan diet, high in complex carbs and low in refined carbs (fruits, vegetables, whole grains, legumes, soy, seeds & nuts). Calories unrestricted. Multivitamin, fish oil, curcumin, vitamin C, B12, CoQ10, lion's mane, probiotic, and magnesium. 21 meals/week and supplements provided to participants and caregivers at no cost to them.
~Exercise: Aerobic (e.g., walking) and strength training 30 minutes/day based on a personalized prescription from an exercise physiologist or certified personal trainer and registered nurse.
~Stress Management: Meditation, gentle yoga-based poses, progressive relaxation, breathing exercises, and meditation (with optional glasses) 1 hour per day, supervised by a certified stress management specialist.
~Group Support: Participants and their spouses/caregivers participate in a support group one hour/session, 3 days/week, supervised by a licensed mental health professional in a supportive, safe environment."
15780909|NCT04606407|Device|LungFit™|Patients will receive inhalations of 150 ppm for 40 min 4 times a day, up to 7 days (maximum 28 treatments)
15780910|NCT04606394|Drug|Trelegy Ellipta 100/62.5/25Mcg Inh 30D|Administration of Trelegy in all patients
15780917|NCT04606355|Diagnostic Test|Visual Acuity|autostereoscopic, monocular dynamic force choice test
15780918|NCT04606355|Diagnostic Test|stereopsis|autostereoscopic dynamic forced-choice depth perception test
15780919|NCT04606355|Diagnostic Test|Color vision|autostereoscopic forced choice monocular or binocular color vision tests
15780920|NCT04606329|Drug|LuminoMark inj.(Conc. for fluorescence)|Injection LuminoMark inj. (Conc. for fluorescence) 0.2mL once in this study.
15780921|NCT04606329|Drug|Charcotrace Inj.|Injection Charcotrace Inj. about 0.3~1mL once in this study.
15780922|NCT04606316|Drug|Nivolumab-Placebo|Intravenous (IV) solution that has no therapeutic effect, used as a control in testing investigational drug. One dose is received prior to surgery.
15780923|NCT04606316|Drug|Nivolumab|Given as intravenous (IV) infusion into a vein.
15780924|NCT04606316|Drug|Ipilimumab-Placebo|Intravenous (IV) solution that has no therapeutic effect, used as a control in testing investigational drug. One dose is received prior to surgery.
15780925|NCT04606316|Drug|Ipilimumab|Given as intravenous (IV) infusion into a vein.
15780926|NCT04606316|Procedure|Surgery|Treatment of disease or injury by cutting, abrading, suturing, or otherwise physically changing body tissues and organs.
15780927|NCT04606303|Drug|Toripalimab combination with platinum-containing dual-drug chemotherapy.|"cisplatin + paclitaxel/ albumin-bound paclitaxel/ gemcitabine/ Pemetroxel+ Toripalimab (cisplatin 75mg/m2 (D1), paclitaxel 175mg/m2 (D1), or albumin-bound paclitaxel 260mg/m2 (D1), or gemcitabine 1250mg/m2 (D1, D8), or Pemetroxel 500mg/m2 (D1)), Toripalimab 240mg D1, Q3W.
~If the patient is SD or PD, Toripalimab combined with platinum-containing dual-drug chemotherapy in the third cycle will continue, and a total of 4 cycles can be carried out at most, and the therapeutic effect will be evaluated after each cycle of treatment. If the patient is PR or CR at any time during the treatment (after treatment in the third or fourth cycle), the surgical treatment will be entered. If PR or CR is still not reached after treatment in the fourth cycle, the endpoint of the trial will be reached, theobservation of the patient will be finished, and the subsequent treatment will be decided by the clinician."
15780928|NCT04606290|Device|O2matic HOT|Automated oxygen titration with O2matic HOT
15780929|NCT04606290|Device|Oxygen concentrator|Fixed dose oxygen flow from concentrator
15780930|NCT04606277|Other|Smartphone addiction scale, physical activity scale and depression questionnaire|Telephone addiction of the subjects was measured. Then, physical activity levels were questioned, and finally depression scale was applied.
15780931|NCT04606264|Dietary Supplement|Gatorade ®|This randomized group will be asked to drink a specific amount of Gatorade ® the night before and 2-3 hours prior to their procedure.
15780932|NCT04606264|Dietary Supplement|Clearfast ®|The randomized group will be asked to drink a specific amount of Clearfast ® the night before and 2-3 hours prior to their procedure.
15780933|NCT04606264|Drug|Preoperative Gabapentin|This randomized group will receive gabapentin depending on age of each patient. If patients age <65, receive 1 dose of 600mg gabapentin. If patients age ≥ 65 receive 1 dose of 300mg.
15780934|NCT04606264|Drug|Neuraxial Morphine Injection|This randomized group will receive a neuraxial morphine injection (intrathecal morphine/hydromorphone).
15780935|NCT04606264|Drug|Regional Technique Analgesia|This randomized group will receive regional technique analgesia with sodium channel nerve blockade pharmacotherapy (ie nerve block)
15780936|NCT04606264|Drug|Perphenazine|This randomized group will receive 8 mg of perphenazine orally preoperatively.
15780937|NCT04606264|Drug|Aprepitant|This randomized group will receive 80 mg of aprepitant orally preoperatively.
15780938|NCT04606264|Drug|Totally intravenous Anesthesia (TIVA)|This randomized group will receive propofol (TIVA) intravenously with titration to desired amnestic and anesthetic goals.
15780939|NCT04606264|Other|Stroke volume comparator|For this randomized group, fluids will be replaced by keeping stroke volume and cardiac output within appropriate limits to optimize blood pressure and heart rate.
15780940|NCT04606264|Other|Fluid Therapy|This randomized Maintain euvolemia by measuring fluid output and calculate losses by surgical type. Replace fluid as appropriate with crystalloid, while maintain blood pressure and heart rate.
15780941|NCT04606264|Drug|Ketamine|This randomized group will receive ketamine intravenously during the surgery.
15780942|NCT04606264|Drug|Lidocaine|This randomized group will receive lidocaine intravenously during and after the surgery.
15780943|NCT04606264|Drug|Intraoperative opioids|This randomized group will receive intraoperative intravenous opioid infusions.
15780944|NCT04606264|Drug|Primary Anesthetic Spinal|This randomized group will receive spinal anesthesia and sedation as needed intravenously with titration to desired amnestic and anesthetic goals
15780945|NCT04606264|Drug|Primary Anesthetic Volatile Agent|This randomized group will receive inhalational volatile anesthetic (ie sevoflurane) titration to desired amnestic and anesthetic goals.
15780946|NCT04606264|Drug|Postoperative Gabapentin|This randomized group will receive gabapentin depending on age of each patient. If patients age <65, receive 1 dose of 300mg gabapentin. If patients age ≥ 65 receive 1 dose of 100mg.
15780947|NCT04606251|Other|Exercise|The intervention to be carried out in the study consists of physical exercises for the neck, upper and lower extremities, and trunk; It is a program that includes the addition of cognitive tasks such as memory, word finding, processing during each repetition.
15780948|NCT04606238|Other|Decision Aid|Oncologists and patients will use the decision aid in the same situation (change of treatment needs to be discussed with the patient - either because of disease progression or treatment toxicity or other reasons (e.g. change of care setting).
15780949|NCT04606225|Drug|Losartan|administration of losartan (50 mg) (oral) Cozaar Oral Tablet
15780950|NCT04606225|Drug|Placebo Oral Tablet|administration of placebo (oral)
15780951|NCT04606212|Drug|Losartan|administration of losartan (50 mg) (oral)
15780952|NCT04606212|Drug|Placebo Oral Tablet|administration of placebo (oral)
15780953|NCT04606199|Behavioral|Mindfulness-based intervention, up to 5 minutes 0-3 times/day|The intervention consist of mindfulness and compassion-based practices that are selected to maximize their effect on stress targets. Interventions include, for example, practices that focus on the breath/body (e.g., 3 minute breathing space; compassionate body scan; five senses mediation), on increasing participants' inner resources (e.g., imaging a safe person or safe place), on reducing negative affect (e.g., self-compassion and acceptance-based practices), or on increasing positive emotions (e.g., gratitude practice; metta practices).
15780954|NCT04606186|Dietary Supplement|Lactobacillus reuteri Prodentis®-lozenges (DSM 17938, ATCC PTA 5289)|Supplementary intake of Lactobacillus reuteri Prodentis®-lozenges (DSM 17938, ATCC PTA 5289) 2 times per day for 12 weeks
15780955|NCT04606186|Dietary Supplement|Placebo-lozenges (BioGaia)|Placebo-lozenges (BioGaia)
15780956|NCT04606173|Other|Team Education for Adopting Changes in Healthcare (TEACH)|TEACH, an educational strategy which includes evidence-based strategies to improve task-specific teamwork will occur across 4 brief (20-30 minutes) team meetings over a 12-week period.
15780957|NCT04606160|Behavioral|Single Session Problem-Solving Intervention|The intervention will be a researcher led 30-45 minute session using the problem-solving module from the Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Issues (MATCH-ADTC protocol.
15780958|NCT04606147|Procedure|Serratus Anterior Plane Block|The block is performed with full aseptic precautions.in lateral position &arm abduction. US probe placed on the patient's midaxillary line in the transverse plane, at the level of the fifth rib.With the rib, pleural line, and overlying serratus anterior and latissimus dorsi muscles visualized, the skin and subcutaneous tissue can be topicalized. Then, using ultrasound guidance, A regional block needle is advanced in-plane at an angle of approximately 45 degrees towards the fifth rib.Correct location of the needle tip in the fascial plane deep to serratus anterior muscle will be confirmed by injecting 0.5-1 ml normal saline and seeing hydrodissection of fascial plane between SAM and 5th rib. After aspiration to avoid intravascular injection 30 ml of levobupivacaine 0.25% is injected anteriorly to the rib and deep to the serratus anterior muscle. The entirety of the needle should be visualized at all times throughout the procedure.
15780959|NCT04606147|Procedure|Erector spinae plane block|The block is performed with full aseptic precautions at T5 level. T5 transverse process is identified by us as flat, squared-off acoustic shadows with only a very faint image of the pleura.In longitudinal us view following layers will be visible superficial to transverse processes: skin and subcutaneous tissue, trapezius, erector spinae muscle.Skin is topicalised , then echogenic block needle inserted in- plane to the ultrasound beam in a cranial-to-caudal direction until contact is made with the T5 transverse process. After aspiration to avoid intravascular injection 30 ml levobupivacaine 0.25% was injected and separation was seen. 6-13-MHz, linear transducer set for small parts and a depth of 4-6 cm was used
15780960|NCT04606134|Device|Hybrid fractional laser|two treatments given one month apart
15780961|NCT04606134|Other|Alastin Regenerating Skin Nectar with TriHex Technology|applied twice daily
15780962|NCT04606134|Other|Cetaphil face cream|applied twice daily
15780963|NCT04606121|Combination Product|enhanced day care of TCM include acupuncture, massage, tai ji quan, TCM herbal medicine|acupuncture twice in enhanced day care of TCM massage twice in enhanced day care of TCM tai ji quan one time in enhanced day care of TCM TCM herbal powder three times a day
15780964|NCT04606108|Drug|Camrelizumab in Combination With Neoadjuvant Chemotherapy|camrelizumab in combination with Liposome doxorubicin and Ifosfamide
15780965|NCT04606095|Diagnostic Test|EEG|EEG with QST (evoked Pain and Visual Stimulation Assessment)
15780966|NCT04606095|Diagnostic Test|Neuroimaging EEG/fMRI|This will be done to monitor areas of the brain that are involved in thinking and processing pain. The scanner stimulates the brain to send out signals that will be recorded and analyzed. Additionally, during the MRI the participants brain's electrical activity with will be measured with an EEG machine for part of the MRI. About halfway through the scan, participants will have the EEG equipment removed and then will return to the fMRI scanner for a few additional scans.
15780967|NCT04606095|Device|HD-tDCS treatments|HD-tDCS treatments (5 active and 5 sham)
15780968|NCT04606095|Device|Sham HD-tDCS treatments|HD-tDCS treatments (5 active and 5 sham)
15780969|NCT04606082|Drug|Granulocyte Colony Stimulated Factor|GCSF was intrauterine injected once at ovum pick up day
15780970|NCT04606082|Drug|Human Chorionic Gonadotropins|500 IU of HCG was injected intrauterine once at ovum pick up day
15780971|NCT04606069|Drug|Regadenoson|Regadenoson will be given intravenously as 5 ug/kg (up to 400 mg/patient) loading dose over 30 mins (to avoid unpleasant side effects sometimes associated with the rapid bolus injection of Regadenoson), followed by a continuous slow infusion (1.44micrograms/kg/hour) with the use of a pediatric infusion pump for 6 hours.
15780972|NCT04606069|Other|Placebo Control|The same volume of saline will be given intravenously for 6 and half hours.
15780973|NCT04606043|Procedure|Sandblasting|Sandblasting will be applied onto the vestibular surfaces of the teeth before applying the etchant.
15780974|NCT04606043|Procedure|Acid Etching|Only acid etching will be applied onto the vestibular surfaces of the teeth before rebonding
15780975|NCT04606030|Device|BioBridge® Collagen Matrix|BioBridge Collagen Matrix (BioBridge) is a sterile implantable bio-compatible and biodegradable surgical mesh ribbon comprised of highly purified porcine collagen. The Class II device was cleared by CDRH Division of Surgical Devices on 8 January 2016 under 510(k) K151083. The device will be used for soft tissue surgical support at the time of vascularized lymph node transplant surgery (VLNT); the device will be used, specifically, for surgical support of the lymphatic component of the soft tissue.
15780976|NCT04606030|Procedure|Vascularized Lymph Node Transfer (VLNT)|Micro-surgical procedure for vascularized lymph node transfer (VLNT)
15780977|NCT04606017|Drug|Caltrate Pill|VitD3 supplementation was defined as patients additionally took oral vitD3 (125 IU/d) within 3 days after the first infusion and persisted in the whole follow-up period.
15780978|NCT04606004|Other|Stool application|Application of stool from the stoma bag 4 weeks prior, twice daily for 10 minutes at a time. However, with the stool application no barrier cream will be applied to the skin in order for the stool to achieve penetrance to the skin. Stool application will include removing any barrier creams gently, applying a thin layer of stool with a surface area shown in illustration to ensure consistent coverage, and placing a diaper on the subject. Depending on the type of the participant's ostomy, a medication cup, syringe, and/or tongue blade provided by the researchers, may be used to aid in the application of stool. After 10 minutes of application, the caregiver or inpatient healthcare provider will remove the entire thin layer of stool gently without excessive friction, just enough to remove the stool, a dabbing motion is preferred.
15781003|NCT04605822|Other|Standard-of-care clinical assessment of the skin|Clinical skin examination with dermatoscope by an experienced dermatologist and risk assessment of pigmented lesions (melanoma vs. naevus). All participants of this study will undergo Standard-of-care clinical assessment of the skin at baseline and the follow-up visits up to month 24.
15780979|NCT04606004|Other|Standard of care skincare|"Standard of care for skin care pre-operatively: which is either no application of barrier cream, or an application of an over the counter (OTC) skin barrier such as Aquaphor, Desitin, or Vitamin A&D if the patient is experiencing skin redness from urine incontinence.
~Standard of care skin creams post op: 3M no-sting immediately post op, once begin stooling- stoma powder, 3M no-sting, Critic-aid thick barrier paste will be applied to the skin."
15780982|NCT04605978|Drug|S95011 concentrate for solution for infusion|IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
15780983|NCT04605978|Drug|Placebo concentrate for solution for infusion|IV administration every 2 weeks until week 4 and then every 3 weeks until week 10.
15780984|NCT04605952|Diagnostic Test|Repeat SARS-CoV-2 IgG antibodies at 45-65 days|All cases who initially tested positive for SARS-CoV-2 IgG antibodies would undergo a repeat test at 45-65 days
15780985|NCT04605939|Device|PET/MR|Each subject undergoes PET/MR imaging within 40-60 minutes after injection.
15780986|NCT04605939|Device|PET/CT|Each subject undergoes PET/CT imaging within 40-60 minutes after injection.
15780987|NCT04605926|Biological|EQ001|itolizumab [Bmab600]
15780988|NCT04605926|Biological|EQ001 Placebo|EQ001 Placebo
15780989|NCT04605913|Combination Product|Modified GCN+TTF treatment|The regimen will consist of gemcitabine (G) administered at a dose of 800 mg/m2, cisplatin (C) 30 mg/m2, and protein-bound paclitaxel (N) 150 mg/m2 administered on cycle 1 day 1 and every 2 weeks thereafter and TTF will be administered daily (150kHz 18 hours/day) starting with Cycle 1 Day 1 (dose level 1). One cycle consists of 28 days including 2 chemotherapy treatments (same regimen studied in the PAXG trial: Reni BJC 2016 without capecitabine). After completing 6 cycles, patients will then transition to a maintenance phase of G administered at a dose of 1000 mg/m2 every 2 weeks and daily TTF (150 KHZ 18 hours/day) until progression of disease (POD) per RECIST v1.1.
15780990|NCT04605900|Device|Orthopedic Footwear|The orthopedic footwear used by the OF Group was manufactured by the company J. Andrade Ferreira Neves Lda. with materials suitable for the diabetic foot, as registered with INFARMED under registration ID 279515.
15780991|NCT04605900|Device|Standard Footwear|In the SF Group, it was recommended to use standard shoes more suitable for diabetic foot, with some specific characteristics, such as sports or walking shoes. The acquisition or not of a more suitable shoes by the participants was at the discretion of each individual.
15780992|NCT04605900|Device|Plantar Orthoses|The plantar orthoses (PO) that both groups used for distribute of plantar loads was based on the principle of total contact. The confection material consisted in a liner of EVA shore 20º and polyurethane filling ELAX flexible (expandable) from OKM Química Ortopédica SL.
15780993|NCT04605900|Behavioral|Education on foot self-care|"An information leaflet with foot care was delivered, with the aim of ensuring that participants were informed about the care they should continually take with their feet during the study period. This leaflet was created based on the guidelines of the Associação Protetora dos Diabéticos in Portugal."
15780994|NCT04605887|Drug|Angiotensin 1-7|Ang 1-7 subcutaneously 500 mcg/kg /day
15780995|NCT04605874|Other|Package Quantity (cigarillos)|After a 5-day period of smoking their own preferred brand of cigarillos, participants will begin a 15-day experimental period when they will be randomized to one of two conditions, 2 cigarillos per pack versus 4 cigarillos per pack.
15780996|NCT04605861|Drug|Liraglutide|Liraglutide Injection, once a day, injected subcutaneously on the sites of abdomen, thigh or upper arm. The initial dose of Liraglutide Injection will be 0.6 mg per day. The dose is escalated every one to two weeks to reduce the gastrointestinal symptoms. At Week 7, the dose is increased to 3.0 mg per day. For the subjects who are not able to tolerate the target dose of 3.0 mg,the dose is reduced to 2.4 mg a day and escalated to the dose to 3.0 mg within two weeks. If the subjects are still unable to tolerate this dose (3.0 mg), the treatment is terminated.
15780997|NCT04605861|Drug|Placebo|Placebo Injection, once a day, injected subcutaneously on the sites of abdomen, thigh or upper arm. The initial dose of Placebo Injection will be 0.6 mg per day. The dose is escalated every one to two weeks to reduce the gastrointestinal symptoms. At Week 7, the dose is increased to 3.0 mg per day. For the subjects who are not able to tolerate the target dose of 3.0 mg,the dose is reduced to 2.4 mg a day and escalated to the dose to 3.0 mg within two weeks. If the subjects are still unable to tolerate this dose (3.0 mg), the treatment is terminated.
15780998|NCT04605848|Diagnostic Test|Infrared themrography|measurement of temperature and microcirculation of the skin overlaying BAT depots in the region of FDG-uptake detected by 18F-FDG PET/CT before and after a cold test
15780999|NCT04605835|Diagnostic Test|ULTRASONIC VISUALIZATION OF OBSTRUCTIVE UROPATHIES IN CHILDREN.|The purpose of this study was to develop proposals and recommendations for improving the safety of urological examination of children with obstructive uropathy by using Doppler ultrasound. Based on the results of a comprehensive urological examination of 665 children with congenital ureteral obstruction, a program for scoring the results of ultrasound examination has been developed, which allows using the safest and most informative methods to reliably determine the functional state of the renal parenchyma and the degree of urodynamic disorders in children with obstructive uropathy.
15781000|NCT04605822|Device|3D imaging Total Body Photography Vectra® WB360|3D Total Body Photography Vectra® WB360 (Canfield Scientific, Parsippany, New Jersey, USA) and its digital dermoscopic camera (VISIOMED® D200evo dermatoscope) and scoring of pigmented skin lesions. All participants of this study will undergo 3D TBP at baseline and the follow-up visits up to month 24.
15781001|NCT04605822|Device|2D imaging FotoFinder ATBM® Master imaging system|2D imaging with FotoFinder® Mole Analyzer and scoring of pigmented skin lesions. All participants of this study will undergo 2D imaging FotoFinder ATBM® Master imaging system at baseline and the follow-up visits up to month 24.
15781002|NCT04605822|Device|Smartphone application (SkinVision®)|Smartphone application for all dermatoscopically documented pigmented skin lesions in all study participations and record of risk assessment of the health application (low, medium or high risk) to compare the app's accuracy in risk assessment with the AI tools and the dermatologist. The SkinVision® smartphone app is CE certified.of skin lesions. All participants of this study will undergo Smartphone application (SkinVision®) at baseline and the follow-up visits up to month 12.
15781034|NCT04605575|Drug|Pyrotinib 320mg + Vinorelbine|pyrotinib 320mg tablets administered daily by mouth, vinorelbine(po) 80 mg/m2 weekly (following a first cycle at 60 mg/m2) administered on day 1 and day 8 of 21 day cycle. Treatment lasts for two cycles
15781004|NCT04605809|Device|combined motor and cognitive training|The combined motor and cognitive training group will receive physical fitness training under sitting and standing, walking training while sequentially or simultaneously perform cognitive training for 45 minutes per session, 3 times a week for 4 weeks.
15781005|NCT04605809|Device|motor training alone|The motor training alone group will receive the same set of physical fitness training while sitting, standing, and walking as the combined motor and cognitive training group for 45 minutes per session, 3 times a week for 4 weeks.
15781006|NCT04605809|Device|cognitive training alone|The cognitive training alone group will receive the same set of cognitive training while sitting as the combined motor and cognitive training group for 45 minutes per session, 3 times a week for 4 weeks.
15781007|NCT04605796|Combination Product|Toripalimab combined with Bevacizumab|"Experimental group:
~Toripalimab, 240mg, IV infusion, every 3 weeks (q3w). combined with Lenvatinib 15 mg/kg (IV infusion, every 3 weeks (q3w).. Continuous infusion, in a cycle of 3 weeks (21 days), until occurrence of termination event specified in the protocol."
15781008|NCT04605783|Dietary Supplement|Bimuno®|Bimuno® (3.65g powder) once a day with placebo as a second dose taken as 1 sachet twice daily with meals. Product will be started 3 days prior to arrival and maintained for a duration of 10 days during travel or deployment.
15781009|NCT04605783|Dietary Supplement|Florastor®|Florastor® (500mg) taken as 1 sachet twice daily with meals. Product will be started 3 days prior to arrival and maintained for a duration of 10 days during travel or deployment.
15781010|NCT04605783|Dietary Supplement|Travelan®|Travelan® (600mg) taken as 1 sachet twice daily with meals. Product will be started 3 days prior to arrival and maintained for a duration of 10 days during travel or deployment.
15781011|NCT04605783|Other|Placebo|Maltodextrin - To be started 3 days prior to arrival and maintained for a duration of 10 days during travel or deployment.
15781012|NCT04605770|Drug|pemetrexed+cisplatin|"Pemetrexed 500 mg/m2 (Day 1) and cisplatin 75 mg/m2 (Day 1) will be given via intravenous (IV) infusion. Each cycle consists of 21 days, and this combination therapy will be continued until Cycle 6. Starting from Cycle 7, pemetrexed alone will be administered every 3 weeks (Q3W) as IV infusion until disease progression.
~Vitamin B12 1000 mcg intramuscular (IM) injection will be given within 14 days prior to the first dose of pemetrexed, every 9 weeks (on the same day as study treatment) thereafter, and then 21 days after the last dose of pemetrexed. Folic acid 1 mg will be administered daily starting from 14 days before the first dose of pemetrexed and continued until 21 days after the last dose of pemetrexed. Study treatment will be continued until PD, unacceptable AE, or decision to discontinue by subject or physician."
15781013|NCT04605757|Other|Clinical, functional and radiological lung involvement evolution|Observational / Clinical, functional and radiological long term evolution of SARS-COV-2 lung involvement
15781014|NCT04605744|Behavioral|Smoking cessation counseling|"Patients will be given a briefing on the benefits of smoking cessation in the peri-procedural period around their interventional pain procedure. They will also be provided an informational sheet from the American Society of Anesthesiologists promoting cessation. The sheet will contain the 1-800-QUITNOW national hotline phone number.
~Additional an enrollment folder will provided that contains referral information to Cooper's Tobacco Cessation program. This service, free of charge to Cooper Health patients consists of 5 tobacco cessation counselors who use personalized cessation plans, individual and group counseling cessations, Chantix, and education to promote smoking cessation."
15781015|NCT04605731|Biological|Durvalumab|Given IV
15781016|NCT04605731|Biological|Tremelimumab|Given IV
15781017|NCT04605718|Drug|RO7223280|RO7223280 will be administered by intravenous (IV) infusion at escalating doses from 10mg to 4800mg, as per the dosing schedules described above. These are putative doses and the maximum daily dose that must not be exceeded is 5000mg.
15781018|NCT04605705|Combination Product|Optimization of the cardiac output, the temperature, the hemoglobin in order to have the NIRS value by up to 80%.|Several maneuvers will be performed in case the NIRS values are below 50%, such as an increase in cardiac output, temperature, hemoglobin to optimize the NIRS value by up to 80%.
15781019|NCT04605679|Procedure|Kidney Transplantation|A HCV negative or previously successfully treated recipient with a HCV positive kidney graft
15781020|NCT04605666|Biological|CD19-CAR-T2 Cells|CD19-CAR-T2 T cells will be infused over 10-15 minutes on Day 0.
15781021|NCT04605653|Behavioral|Weight Management Intervention|Participants attend group and individual dietary education sessions. Participants create a diet plan that satisfies their needs. Participants aim to lose 1 pound weekly until a BMI of 25 is reached. Participants are evaluated through daily self-weighing, dietary records, and food frequency questionnaires.
15781022|NCT04605640|Behavioral|Weight Management Intervention|Participants attend group and individual dietary education sessions. Participants create a diet plan that satisfies their needs. Participants aim to lose 1 pound weekly until a BMI of 25 is reached. Participants are evaluated through daily self-weighing, dietary records, and food frequency questionnaires.
15781023|NCT04605614|Radiation|Copper Cu 64-DOTA-pembrolizumab|Given IV
15781024|NCT04605614|Biological|Pembrolizumab|Given IV
15781025|NCT04605614|Procedure|Positron Emission Tomography|Undergo PET
15781026|NCT04605601|Other|Virtual reality treatment|Tennis, boxing, and baseball games of the Wii Sports package sre used for activating the upper extremity functions of the patients. In the tennis game, patients represent people holding rackets.
15781027|NCT04605601|Other|conventional physiotherapy|As the conventional physiotherapy, neuromuscular electrical stimulation and strengthening exercises for the deltoid, infraspinatus, triceps, biceps, supinator, and wrist extensor muscles, and passive, active, active assistive joint Rage of Motion, and stretching exercises for the shoulder, elbow and wrist joints are applied to the patients in the standardized program for the upper extremity in 10 repetitions.
15781028|NCT04605588|Drug|Nitazoxanide|Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)
15781029|NCT04605588|Drug|Placebo Nitazoxanide|Placebo Nitazoxanide (500 mg po BID for day 1and then 500 mg BID for 4 days)
15781030|NCT04605588|Drug|Ribavirin|Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days)
15781031|NCT04605588|Drug|Placebo Ribavirin|Placebo Ribavirin (600 mg po BID for day 1and then 400 mg BID for 4 days)
15781032|NCT04605588|Drug|Hydroxychloroquine|Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)
15781033|NCT04605588|Drug|Placebo Hydroxychloroquine|Placebo Hydroxychloroquine sulfate (400 mg po BID for day 1 and then 200 mg BID for 4 days)
15781035|NCT04605575|Drug|Pyrotinib 400mg + Vinorelbine|pyrotinib 400mg tablets administered daily by mouth, vinorelbine(po) 80 mg/m2 weekly (following a first cycle at 60 mg/m2) administered on day 1 and day 8 of 21 day cycle. Treatment lasts for two cycles
15781036|NCT04605575|Drug|Pyrotinib plus Vinorelbine|pyrotinib administered daily by mouth（MTD）, vinorelbine(po) 80 mg/m2 weekly (following a first cycle at 60 mg/m2) administered on day 1 and day 8 of 21 day cycle, or vinorelbine(iv) 25 mg/m2 on day 1 and day 8 of 21 day cycle. Treatments will lasts until disease progression (as assessed by the investigator) or unmanageable toxicity.
15781037|NCT04605562|Drug|GP+DDP|Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 3 cycles; induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation; concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation
15781038|NCT04605562|Drug|Palbociclib|Administered orally
15781039|NCT04605562|Radiation|Intensity-modulated radiotherapy|Definitive IMRT of 70 Gy, 33 fractions, 5 fractions/week, 1 fraction/day
15781040|NCT04605562|Drug|PD-1 blocking antibody|Administered every 3 weeks
15781041|NCT04605562|Drug|Galunisertib|Administered orally
15781042|NCT04605549|Drug|CIN-107 Dose 1|CIN-107 tablets by mouth once daily
15781043|NCT04605549|Drug|CIN-107 Dose 2|CIN-107 tablets by mouth once daily
15781044|NCT04605549|Drug|CIN-107 Dose 3|CIN-107 tablets by mouth once daily
15781045|NCT04605549|Drug|Placebo for CIN-107|Placebo for CIN-107 tablets by mouth once daily
15781046|NCT04605536|Other|animation videos|watch animation videos about capsule endoscopy
15781047|NCT04605536|Other|explanation about endoscopy endoscopy|Give general explanations about endoscopy endoscopy
15781048|NCT04605523|Procedure|blood withdrawal|Additional blood sample will be taken within blood collection as part of standard care
15781049|NCT04605510|Other|Passive Cervical Joint Mobilization|It will be applied to the cervical spine, whose dysfunction is detected as a result of the evaluation. The participant will be in the prone position and Grade 3 Central Posterior-Anterior (CPA) passive joint mobilization with Maitland method will be applied for 3 sets, 30 seconds, to the segment to be treated.
15781050|NCT04605497|Diagnostic Test|Continuous glucose monitoring (CGM)|Continual use of CGM to monitor blood glucose levels from enrollment through delivery admission & discharge + additional 10 days during postpartum period
15781051|NCT04605497|Diagnostic Test|Self-Capillary Blood Glucose Monitoring (SCBG)|Conventional SCBG 4x/day testing (standard care in Oregon; fasting and 1-hour postprandial) with blinded CGM every 2 weeks SCBG 4 times/day until delivery admission 10 days duration with each blinded CGM wear
15781052|NCT04605484|Biological|Posoleucel (formerly known as ALVR105; Viralym-M) cells|Infusion
15781053|NCT04605484|Biological|Placebo (visually identical to Posoleucel)|Infusion
15781054|NCT04605471|Drug|Iopromide(Ultravist, BAY86-4877)|The study will be conducted by using pooled data of four company sponsored non-interventional studies with iopromide.
15781055|NCT04605458|Combination Product|Contingency Management|Participants will receive 3-6 counseling sessions, nicotine patches & lozenges, and monetary payment delivered contingent on abstinence verified by CO breath test.
15781056|NCT04605458|Combination Product|Standard Care|Participants will receive 3-6 counseling sessions, nicotine patches & lozenges, and CO breath test monitoring.
15781057|NCT04605445|Procedure|1 visit root canal treatment (endodontics)|Endodontics (root canal treatment). In the enrolment visit, access, opening and identification of root canals can be performed and a suitable temporization will be placed in the tooth if needed. Root canal treatment can be completed in the same visit or performed in another visit where cleaning, shaping and root filling procedures, temporization or permanent restoration will be performed. These procedures are part of the normal clinical praxis. No rigid protocol will be implemented, as a pragmatic design was chosen.
15781058|NCT04605445|Procedure|2 visits root canal treatment (endodontics)|Endodontics (root canal treatment). In the enrolment visit, access, opening and identification of root canals can be performed and a suitable temporization will be placed in the tooth if needed. Root canal treatment can be started, or performed in another visit, lasting 2 visits. In the first visit cleaning and shaping is performed and a medication is put in place in the canals, and the tooth is temporized until the next visit at least one week apart. In the second visit the tooth is root filled and temporization or permanent restoration will be performed. These procedures are part of the normal clinical praxis. No rigid protocol will be implemented, as a pragmatic design was chosen.
15781059|NCT04605432|Drug|PEG-FFI|"Patients with risk factor : on the day before the colonoscopy at 20:00- 21:00 hours, 60gPEG-4000 was mixed with 1L water; 4-6 h before colonoscopy, 120gPEG-4000 was mixed with 2L water.
~Patient without risk factor: 4-6 hours before colonoscopy, 120gPEG-4000 was mixed with 3L water.
~Education completed by experienced researcher."
15781060|NCT04605432|Drug|PEG-nonFFI|"All patients on the day of the colonoscopy:4-6 hours before colonoscopy, 120gPEG-4000 was mixed with 3L water.
~Education completed by ward nurse."
15781061|NCT04605419|Procedure|Calcium electroporation|Areas with Barrett's esophagus high-grade dysplasia will get an injection of calcium chloride in submucosa through an endoscopic system before getting electroporation
15781062|NCT04605393|Drug|Cannabidiol|CBD
15781063|NCT04605393|Drug|Placebo|Placebo
15781064|NCT04605393|Drug|Delta-9-THC|THC
15781066|NCT04605367|Device|Transcranial stimulation|For both tasks, the training modalities are the same. After the pre-test, this group will physically repeat the correct sequence as many times as possible, during 12 blocks of 30s. After this training, they will perform the post-test. And immediately after the post-test, they will receive the real anodal stimulation. The intensity of the current will gradually increase for 30s until it reaches 1mA, will remain constant for 15min, then will gradually decrease for 30s until 0mA is reached. The current density during stimulation will be 0.04 mA/cm². For the manual task the anode will be centered above C4 (according to the international 10-20 EEG system) that is located near the hand area of M1. The cathode will be placed on the supraorbital region ipsilateral to the trained hand (Fp1). For the body task, the anode will be placed in the center of the cortex (Cz) and the cathode will be placed at the medial supraorbital region (Fpz).
15781067|NCT04605341|Device|miniplate|comparison between k wires and miniplate in metacarpal fractures
15781068|NCT04605328|Other|Two dimension and three dimension ultrasound|Patient will undergo 2D and 3D ultrasound evaluation after CS for detection of CSD
15781069|NCT04605302|Device|MCC/MCC-T|Magnetically controlled capsule endoscopy (MCC), with or without tether, is used to visualize the upper gastrointestinal tract
15781070|NCT04605302|Device|Standard gastroscopy|Diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum
15781071|NCT04605289|Drug|lemongrass essential oil gel|"The lemongrass oil gel will be administered by means of a syringe with a bent, blunt-end needle. The needle will be carefully inserted into the periodontal pocket and the gel will be applied in the test sites in a gentle probing manner, attempting to fill the full extent of the pocket. The gel will be applied up to the gingival margin and the excess gel will be removed with sterile gauze.
~Periodontal dressing will be applied after the delivery of the drug, and they will be also asked not to eat for thirty minutes.
~After placement of the gel in situ, patients will be instructed to follow strict oral hygiene protocol and not chew hard or sticky foods at the gel placement sites for rest of the week."
15781072|NCT04605289|Drug|Placebo|"The placebo will be administered by means of a syringe with a bent, blunt-end needle. The needle will be carefully inserted into the periodontal pocket and the gel will be applied in the test sites in a gentle probing manner, attempting to fill the full extent of the pocket. The gel will be applied up to the gingival margin and the excess gel will be removed with sterile gauze.
~Periodontal dressing will be applied after the delivery of the drug, and they will be also asked not to eat for thirty minutes.
~After placement of the gel in situ, patients will be instructed to follow strict oral hygiene protocol and not chew hard or sticky foods at the gel placement sites for rest of the week."
15781073|NCT04605289|Procedure|Scaling and root planing|Conventional mechanical treatment by ultra-sonic scalers
15781074|NCT04605276|Other|No intervention|No intervention
15781075|NCT04605263|Device|STN-PPN DBS Surgery|Subject will undergo standard bilateral STN DBS surgery and have 2 additional leads placed in the same burr with bilateral PPN targets
15781076|NCT04605263|Procedure|Deep Brain Stimulation Surgery (DBS)|DBS lead implantation of bilateral STN
15781077|NCT04605250|Other|Respiratory variability before and after surgery|The procedure consist of measuring thoracic chest movement and then calculating the respiratory variability reflected by the coefficient of variation in patients undergoing a surgery. A first recording is done during preoxygenation period using as baseline for further comparisons. (T0, 10 min) The second recording is after extubation during the postoperative recovering period, 30 minutes after interruption of sedations. (T1, 20 min, SSPI ou SIPO) The third recording is before transferring back to classical hospitalization, 1h after T1 (20 min). A fourth recording will be realized 24h after surgery for patients hospitalized in the post operative intensive care unit (T3, 20 min) Optional recordings may be realized if the patient is developing a postoperative respiratory complication during his hospital stay. A follow up for maximum 7 days consisting in consulting the medical file will be realized.
15781078|NCT04605224|Behavioral|Culinary class|This hands-on, optional course teaches students how to measure and weigh ingredients, read and follow recipes, apply various food preparation, cooking and assembly techniques, as well as prepare meals, as per the provincial curriculum
15781079|NCT04605211|Behavioral|Online Mindfulness Meditation|Complete online audio-based mindfulness meditation exercises
15781080|NCT04605211|Other|Internet-Based Webinars|Attend webinars
15781081|NCT04605198|Behavioral|Modified Mindfulness-based Stress Reduction|Participants will be trained in mindfulness meditation and the applicability of mindfulness practices to daily life. During MBSR programming, teachers will lecture about key topics in mindfulness and lead class discussions. Participants are given homework assignments, such as listening to guided meditations. Participants are given opportunities to ask the instructor questions and to share their experiences with each other. Each session focuses on a different key topic. Topics are: Session 1: Introduction; Session 2: Understanding Perceptions; Session 3: Hatha Yoga, Sitting Meditation, Walking Meditation; Session 4: Concentration & Awareness; Session 5: Unhealthy Patterns &Getting Unstuck; Session 6: Transformational Coping Strategies; Session 7: Mini-retreat; Session 8: Maintaining Discipline & Flexibility; Session 9: Course Review.
15781082|NCT04605198|Behavioral|Health Promotion Wellness Classes|Sessions will cover the following general wellness topics: Session 1; Introduction; Session 2: Envisioning Health Through Art; Session 3: Chronic Disease 1 (Heart Health); Session 4: Chronic Disease II (Diabetes); Session 5: Nutrition and Hydration; Session 6: Infectious Disease Prevention; Session 7: Skin Care; Session 8: Oral Health; Session 9: Promoting Social Integration & Course Graduation.
15781083|NCT04605185|Drug|Donafenib Tosilate Tablets|100mg Qd/150mg Qd/100mg Bid, po
15781084|NCT04605185|Biological|Toripalimab Injection|240 mg, iv drip,q3w
15781085|NCT04605172|Other|hospitalization for premature birth|Number of inborn and outborn infants prematurely born during a specific period of time
15781086|NCT04605159|Biological|RSV MAT|One dose of RSV MAT vaccine reconstituted with NaCl solution administered intramuscularly in the non-dominant arm.
15781087|NCT04605159|Drug|Placebo|One dose of lyophilized sucrose reconstituted with NaCl solution administered intramuscularly in the non-dominant arm.
15781088|NCT04605146|Behavioral|Tele-monitoring|"The tele-monitoring will consist in filling in a specific questionnaire once a week in the first 6 months, every 2 weeks until 12 months, and on-demand (in case of upcoming toxicity, at any time). These questionnaires will be reviewed by a coordinating nurse. According to the result of the questionnaire, the coordinating nurse will adapt patients' management, either by giving them a phone call, or inviting them to directly contact their medical department, or even plan an emergency hospitalization if necessary. The coordinating nurse will closely work with the investigator to adapt patients' management.
~Quality of life questionnaire (FACT-G) will also be filled in at inclusion, M3 and M12."
15781089|NCT04605133|Device|Electrical impedance tomography|Every patient is monitored with electrical impedance tomograpy before, during and after prone position.
15781090|NCT04605120|Procedure|Cervical fusion|1- or 2-level ACDF (Anterior Cervical Discectomy and Fusion) combined with bone graft
15781091|NCT04605107|Drug|Epifasi: Human chorionic gonadotrophin|IM Injection of 1 ampoule contains 5000 I.U. of Human chorionic gonadotrophin
15781092|NCT04605107|Drug|Pregnyl: Human chorionic gonadotrophin|IM Injection of 1 ampoule contains 5000 I.U. of Human chorionic gonadotrophin
15781093|NCT04605094|Biological|Benralizumab|Benralizumab by subcutaneous injection until Week 16, and then benralizumab by subcutaneous injection during the extension period.
15781094|NCT04605094|Biological|Placebo / Benralizumab|Placebo by subcutaneous injection until Week 16, then benralizumab by subcutaneous injection until Week 52.
15781097|NCT04605068|Procedure|Transverse preputial island flap (Duckett's technique)|
15781098|NCT04605068|Procedure|Double-faced preputial flap (DFPF)|
15781099|NCT04605055|Dietary Supplement|Low Oxalate Diet|Participants will consume a diet that is controlled in its daily contents of oxalate and calcium, and in its content of carbohydrate, fat, and protein.
15781100|NCT04605055|Dietary Supplement|High Oxalate Diet|Participants will consume a diet that is controlled in its daily contents of oxalate and calcium, and in its content of carbohydrate, fat, and protein.
15781101|NCT04605042|Procedure|wet suction|Before pucturing the lesion, the stylet was removed and the needle was pre-flushed with 1-2 mL of saline using a 10-mL syringe, the endoscopist then punctured the lesion and replaced the 10-mL syringe with a 10-mL pre-vacuum syringe
15781102|NCT04605042|Procedure|standard negative pressure suction|after puncturing the lesion, the endoscopist removed the stylet and attached a 10-mL pre-vacuum syringe for aspiration.
15781103|NCT04605016|Device|Hydrophilic surface implants|A dental implant with hydrophilic surface will be placed and restored in single-tooh gaps of the posterior region of the mandible or maxilla.
15781104|NCT04605016|Device|Hydrophobic surface implants|A dental implant with hydrophobic surface will be placed and restored in single-tooh gaps of the posterior region of the mandible or maxilla.
15781105|NCT04605003|Device|Novel rig-S|A new device created to hold the high level disinfectant and automatically indicate when sterilisation process has been completed
15781106|NCT04605003|Device|Conventional Autoclave machine|The gold standard device to clean all medical instruments
15781107|NCT04604977|Behavioral|Mindfulness|Patients are followed with a standardized program including: education and support for behavioral measures, behavioral sessions, by mindfulness, once per week for 45 minutes for 6 weeks which usually delivered in groups of 4 - 8 patients.
15781108|NCT04604964|Other|Evaluation of anastomotic leakage occurrence|Anastomotic leakage was defined as the communication between the intra and extraluminal compartments due to a defect in the integrity of the intestinal wall originating from the staple line of the neo-rectal reservoir between the colon and rectum
15781109|NCT04604951|Device|Transcutaneous Spinal Cord Stimulation|This non-invasive therapeutic modality uses electrodes applied over the skin to deliver electrical stimulation. It is based on the same principles of ground-breaking work from the investigator's group and others, showing that stimulation of the spinal cord can promote motor and autonomic (cardiovascular, bladder, bowel) recovery in individuals with chronic SCI.
15781110|NCT04604938|Drug|Losartan|administration of losartan (50 mg) (oral)
15781111|NCT04604938|Drug|Placebo oral tablet|administration of placebo (oral)
15781112|NCT04604925|Behavioral|Remote patient monitoring for hypertension|Intervention involves practices making available remote physiologic monitoring treatment management services allowable under Medicare for blood pressure (and weight if desired) to Medicare patients in the practice when ordered by the patient's clinician.
15781113|NCT04604899|Biological|human retinal progenitor cells|single intravitreal injection of 6.0 million human retinal progenitor cells (hRPC)
15781114|NCT04604886|Diagnostic Test|Passive Leg Raising|Passive leg raising is induced by rasing the legs of patients to 45° from horizontal position.
15781115|NCT04604886|Diagnostic Test|Dobutamine stress test|Dobutamine was infused intravenously at the initial dose of 2.5 ug/kg/min. hemodynamic data were recorded from PAC and LiDCO after 5-10 minutes of continuous infusion.
15781116|NCT04604873|Other|Hospital day care follow-up|Regular follow up every month in hospital day care
15781117|NCT04604860|Behavioral|Fitness intervention|Patients will follow exercise plans designed to promote physical activity (exercise and behavioral coaching).
15781118|NCT04604847|Diagnostic Test|blood test|blood test to explore BDNF level
15781119|NCT04604834|Other|PFAT first|Week 1 to week 4: one eyedrop of PFAT (preservative-free artificial tears) every 2 hours. Week 5 to week 8: one eyedrop of APRP (autologous plasma rich platelet) every 2 hours. Week 9 to week 12: one eyedrop of PFAT and APRP every 2 hours.
15781120|NCT04604834|Other|APRP first|Week 1 to week 4: one eyedrop of APRP every 2 hours. Week 5 to week 8: one eyedrop of PFAT every 2 hours. Week 9 to week 12: one eyedrop of PFAT and APRP every 2 hours.
15781121|NCT04604821|Behavioral|Enhanced Milieu Teaching|A behavioral language intervention that uses naturally occurring interactions to facilitate young children's language skills.
15781122|NCT04604821|Behavioral|Parent Education|Parents receive information on child developmental milestones.
15781123|NCT04604795|Drug|GSK3915393 Capsules|GSK3915393 capsules will be given orally.
15781124|NCT04604795|Drug|GSK3915393 Solution for Infusion|GSK3915393 solution for infusion will be administered intravenously.
15781125|NCT04604795|Drug|Placebo capsules|Placebo matching GSK3915393 capsules will be given orally.
15781126|NCT04604795|Drug|Itraconazole|Participants will be administered with GSK3915393 along with ITZ orally
15781127|NCT04604795|Other|Water|Participants will be administered with GSK3915393 along with water orally
15781128|NCT04604795|Other|Grape fruit juice|Participants will be administered with GSK3915393 along with GFJ orally
15781129|NCT04604782|Drug|Regadenoson|Regadenoson (Rapiscan®): Single i.v. bolus dose in stress rest CMR
15781130|NCT04604756|Drug|Losartan|administration of losartan (50 mg) (oral)
15781131|NCT04604756|Drug|Placebo Oral Tablet|administration of placebo (oral)
15781132|NCT04604743|Behavioral|Intervention, TBN|The intervention will target adolescents aged 15-17 years who have not received at least one dose of the HPV vaccine. The intervention has yet to be named; this will occur through the conduct of Aim 1. Our intervention, when developed, will improve knowledge of HPV, COVID-19, the HPV vaccine, and the COVID-19 vaccine (Information), reduce stigma and distrust improving motivation (Motivation), leading to improved vaccine confidence and higher vaccination rates and lower vaccine hesitancy (Behavioral Skills). Each one of these three change objectives will be encapsulated in its own Zoom-based session with the near peer interventionist. We anticipate that each modular session will be no longer than seven minutes; thus, the entire three module intervention will be no longer than twenty-one minutes long.
15781133|NCT04604730|Procedure|Primary anastomosis without protective stoma|Primary anastomosis without protective stoma
15781134|NCT04604730|Procedure|Anastomosis with protective stoma|Anastomosis with protective stoma
15781135|NCT04604717|Other|Pulmonary rehabilitation|8 weeks of exercise training (twice weekly) of education and exercise
15781136|NCT04604704|Drug|Naltrexone|Naltrexone at 4.5 mg/day
15781137|NCT04604704|Dietary Supplement|NAD+|NAD+ will be applied using iontophoresis patches. The patches will be provided by ready-made NAD+ solutions (400 mg) to be applied to the positive electrode of the patch and saline to the negative electrode. The patch is powered by a self-contained battery, producing an electric current to facilitate NAD+ absorption through the skin into the blood. Patches are worn for 4-6 hours once a week.
15781138|NCT04604691|Drug|Blinatumomab for Injection|Blinatumomab will be administered as a continuous intravenous (CIV) infusion at a constant flow rate over four weeks followed by a two-week infusion free interval.
15781139|NCT04604678|Drug|Metformin|Metformin at 1500 mg/day
15781140|NCT04604678|Drug|Naltrexone|Naltrexone at 4.5 mg/day (LDN)
15781141|NCT04604665|Other|High frequency postural change|"Repositioning of patients hospitalized in bed in intensive care units will be carried out with a frequency interval that we call high-frequency to be performed on each patient between an interval between less than or equal to every 2 hours in a full day (24 hours) (minimum goal of 8-10 in 24 hours subtracting 2 or 4 at night and not alter the circadian cycle). The position must be modified in each postural change to right lateral, supine, left lateral, or prone to supine if the position changes every 2 hrs."
15781142|NCT04604665|Other|Conventional care|Repositioning of patients hospitalized will be performed in the current way it is commonly applied to patients.
15781143|NCT04604652|Drug|HTD1801 (BUDCA)|HTD1801 (BUDCA) 250 mg tablets. Dose 1000 mg twice daily with food for 12 weeks.
15781144|NCT04604639|Diagnostic Test|NEWS2 score|Patients seen by ambulance crews within the preceeding 48 hrs of their cardiac arrest will have a NEWS2 score performed to assess the level of physiological deterioration at the time of thei intial assessment.
15781145|NCT04604613|Procedure|Bilateral Salpingectomy with Oophorectomy|Undergo standard of care bilateral salpingo-oophorectomy
15781146|NCT04604613|Procedure|Biospecimen Collection|Undergo collection of blood and tissue samples
15781147|NCT04604613|Procedure|Hysterectomy|Undergo standard of care hysterectomy
15781148|NCT04604613|Other|Laboratory Biomarker Analysis|Correlative studies
15781149|NCT04604613|Procedure|Lymph Node Mapping|Undergo sentinel lymph node mapping
15781150|NCT04604613|Procedure|Sentinel Lymph Node Biopsy|Undergo sentinel lymph node biopsy
15781151|NCT04604600|Drug|amyloid PET|Dynamic PET acquisition for 70 minutes will be acquired after injection of 10±5 mCi 11C-PiB.
15781152|NCT04604587|Drug|1. amyloid PET；2. T807 PET|"Dynamic PET acquisition for 70 minutes will be acquired after injection of 10±5 mCi 11C-PiB
~Dynamic PET imaging 3D acquisition will be acquired 80 minutes after injection of 10 mCi 18F-T807"
15781153|NCT04604574|Other|Indigenous Healing and Seeking Safety|Indigenous Healing and Seeking Safety Intervention: Initial 90-minute meetings will be conducted with the participants; during these meetings, participants will receive information about IHSS, traditional healing, sharing circles, sweat lodge ceremonies, and program details. The sharing circles will take place at Benbowopka Residential treatment Centre in Blind River, Ontario. Each of the sharing circles will be cofacilitated by two Indigenous health-care workers. These facilitators will organize and lead sharing circles daily throughout the 28-day treatment cycle. Each sharing circle will be two hours long. The Seeking Safety program consists of up to 25 treatment topics that aim to teach participants a variety of skills. The majority of topics address the cognitive, behavioral, interpersonal, and case management needs of persons with SUD and posttraumatic stress disorders (PTSD) (Najavits, 2002a). The treatment will adhere to the concept of Two-Eyed Seeing and cultural sensitivity.
15781154|NCT04604561|Device|EnVisio SmartClip|The Envisio SmartClip is an FDA-cleared (approved) device for localization of in-breast lesions. While using The EnVisio™ Navigation System, the system will detect the presence of the SmartClip™ Soft Tissue Marker(s) and provide real-time three-dimensional navigation during the surgery.
15781155|NCT04604561|Device|EnVisio™ Navigation System|The EnVisio™ Navigation System acquires and analyzes electromagnetic signatures that display the relative distance, depth, and direction from the tip of the electrosurgical tool to the implanted SmartClipTM(s) within the surgeon's field of view during the procedure.
15781157|NCT04604535|Dietary Supplement|Concentrated beetroot juice|70mL concentrated beetroot juice (400mg nitrate)
15781158|NCT04604535|Dietary Supplement|Placebo|70mL concentrated nitrate deplete beetroot juice (<0.01mmol/L nitrate)
15781159|NCT04604522|Procedure|Biospecimen Collection|Undergo collection of blood, airway brushings, and nasal brushings (swabs)
15781160|NCT04604522|Other|Medical Chart Review|Patients' medical records are reviewed
15781161|NCT04604509|Drug|Bupropion Hydrochloride Controlled-release|Given PO
15781162|NCT04604509|Drug|Nicotine Replacement|Given via nicotine patch, lozenges, or gum
15781163|NCT04604509|Other|Questionnaire Administration|Ancillary studies
15781164|NCT04604509|Other|Tobacco Cessation Counseling|Receive behavioral smoking cessation counseling
15781165|NCT04604509|Drug|Varenicline|Given PO
15781166|NCT04604496|Drug|PF-06882961 20MG|PF-06882961 in 20 mg oral tablet will be administered on Day 1
15781167|NCT04604483|Device|PTNS|Patients meeting the criteria are treated with PTNS and are evaluated at 3 months and 1 year after end of treatment.
15781168|NCT04604470|Other|Decision tool|no intervention.
15781169|NCT04604457|Other|Palliative care contacts primary care|Palliative care specialist reaches out to primary care to recommend a palliative care consult. If the primary care provider agrees, he/she will write an order for a palliative care consult.
15781170|NCT04604444|Behavioral|Multimodal Intensive Rehabilitation of Aphasia and Apraxia of Speech|Intensive Comprehensive Aphasia (ICAP) and Apraxia of Speech Program
15781171|NCT04604431|Other|iREACH CDS Tool|Pediatric clinicians in the intervention arm will 1) receive the iREACH education module, 2) have the iREACH CDS tool integrated into the EHR templates for use at the 4-, 6-, 9-, 12-month WCC, and 3) will be reminded by EHR-embedded prompts at the 9-month WCC to ask caregivers whether peanuts were introduced and tolerated.
15781172|NCT04604418|Other|No intervention. It is observational|No intervention. It is observational
15781173|NCT04604405|Radiation|photobiomodulation|650nm low energy red light eye irradiation
15781174|NCT04604392|Procedure|Rapid Maxillary Expansion Treatment|The patients were treated with KBME, Hyrax and MIDME maxillary expansion appliances, respectively. All expansion appliances containing a Hyrax expansion screw positioned parallel to the second premolars and were used to correct the posterior crossbite. In the MIDME group, two mini-screws with a diameter of 1.6 mm and a length of 10 mm are located on the right and left sides between the roots of the 2nd premolar and 1st molar teeth with 60-70° angle. KBME and Hyrax expansion appliances were cemented with glass ionomer cement and MIDME was cemented with using the light-cured composite. Same protocol was applied to all patients during RME treatment. Expansion screws in all groups were activated by two turns a day.
15781175|NCT04604366|Drug|misoprostol|it stimulates uterine contractions
15781176|NCT04604353|Diagnostic Test|Polygenic Risk Score|Risk description to patient based on PRS
15781177|NCT04604353|Diagnostic Test|Coronary Calcium Score|Risk description to patient based on CCS
15781180|NCT04604327|Drug|Bemiparin sodium|Prophilactic vs full-dose for 10 days
15781181|NCT04604314|Device|CEREC Tessera|Full ceramic endocrown restorations will be made from the high strength ceramic, CEREC Tessera
15781182|NCT04604301|Device|Celtra Quatro|Full ceramic crowns will be made from the high strength ceramic, Celtra Quatro
15781183|NCT04604288|Biological|HB-adMSC|
15781184|NCT04604275|Drug|Sucrase|1 mL (8,500 I.U.) (one full measuring scoop or 28 drops) per meal or snack for patients up to 15 kg in body weight. 2 mL (17,000 I.U.) for patients over 15kg in body weight. Dosage is 1 or 2 mL (8,500 to 17,000 I.U.) taken orally or by g-tube with each meal or snack diluted in water, milk, or infant formula.
15781185|NCT04604275|Other|Placebo|1 mL of placebo per meal or snack for patients up to 15 kg in body weight. 2 mL of placebo per meal of snack for patients above 15kg in body weight. Dosage is 1 or 2 mL of placebo taken orally or by g-tube with each meal or snack diluted in water, milk, or infant formula.
15781186|NCT04604262|Device|Waterpik|Waterpik dental water jet
15781187|NCT04604249|Diagnostic Test|SARS-CoV-2 rapid diagnostic test (COVID-PRESTO® IgM/IgG, AAZ, Boulogne-Billancourt, France)|Presence of specific SARS-CoV-2 antibodies (IgM or IgG).
15781188|NCT04604236|Behavioral|Mapping Enhanced Counseling|Practitioner-led, collaborative discussion with the youth and their caregiver on co-creating guide maps for decision making around starting treatment and continuing substance use that can help users organize information and think through a series of steps, questions, and behavior choices. encountered when attempting to initiate substance use treatment services. MEC is a communication and decision-making approach that uses graphic visualization tools to train individuals to monitor and control their decision making, improve judgment and behavioral choices (self-regulation), and improve communication and mutual understanding.
15781189|NCT04604236|Behavioral|Active Linkage|Practitioner-led, collaborative discussion with the youth and their caregiver on how to overcome barriers encountered when attempting to initiate substance use treatment services. Discussion focuses around the top barriers identified through assessment and identification of 1 or more treatment agency/options that fit the family's needs. Practitioner takes a more active role in addressing barriers to treatment by helping the family find ways to access resources for payment, childcare, or other needs, and actively linking them to the treatment provider (e.g., scheduling the initial appointment with family present).
15781190|NCT04604223|Drug|Pioglitazone 45 mg|Pioglitazone will be started at 45 mg/day dose for 10 days, after 10 days, the dose will be reduced to 30 mg/day to minimize possible adverse events. The treatment will be continued for 4 weeks (28 days) total
15781191|NCT04604210|Procedure|Transcranial magnetic stimulation|Transcranial magnetic stimulation (TMS) is a noninvasive FDA-approved technique that is commonly used as a treatment for depression. It has been shown to focally activate specific brain regions that are believed to be underactive in patients suffering from depression. In this study, TMS will be administered within FDA-approved guidelines under the supervision of a physician with experience in administering the treatment and monitoring for complications.
15781194|NCT04604184|Drug|BI 764198|BI 764198
15781195|NCT04604184|Drug|Placebo|Placebo
15781196|NCT04604171|Behavioral|Action Observation Training|Action Observation Training (AOT) is composed, according to Franceschini et al. (2012), by 20 different videos of daily activities (actions) carried out with the upper limbs. Patients underwent only one task per day for 20 sessions, starting from the easiest. Each action (unimanual or bimanual) is observed from a first-person perspective. Actors in the videos are young non-disabled people, either men or women. Patients are asked to carefully observe the videos, in order to prepare themselves to imitate the presented actions, while the therapist consistently holds the patient's attention with verbal feedback. At the end of each sequence, the therapist prompts the patient to perform the same movement with the paretic upper limb over a time period of 2 minutes, providing verbal instructions or help, if needed. Each session lasts about 30 minutes (3 min of sequence observation and 2 min of action performance for 3 motor sequences repeated twice).
15781197|NCT04604171|Behavioral|Task Oriented Training|In Task Oriented Training patients performed functional activities with the upper limbs, using the same objects for AOT, in both unimanual and bimanual modalities, without watching the video beforehand. The therapist just provided for verbal instructions and feedback, avoiding demonstrative or imitative indications. The therapist could passively support the movement if patients were completely unable to perform the actions. When necessary, the therapists could also actively facilitate the upper limb movement if patients were unable to correctly perform the actions. Based on the patient's level of motor ability and progress, the levels of movement and task difficulty could be adjusted accordingly. Patients underwent one task per day for 20 sessions. Each session lasted about 30 minutes.
15781656|NCT04600310|Device|ULTRAPREP|ULTRAPREP device for reducing OR prep times.
15781198|NCT04604171|Behavioral|Conventional Treatment|Conventional treatment consists of a range of different patient-tailored interventions, selected by the therapist on the basis of the functional level of the patient. Treatment sessions include training for transfers, mobility, walking up and down steps, balance tasks and tailored functional tasks for the upper limbs (unimanual and bimanual). Moreover, it is also provided for joint and soft tissue mobilization, specific sensory stimulation, exercises to increase strength, both for lower and upper limbs. Each session lasted about 60 minutes.
15781199|NCT04604158|Behavioral|Elly Mobile Phone Application|The Elly mobile phone application delivers daily audio recording aimed at reducing anxiety, stress, loneliness, and social isolation.
15781200|NCT04604145|Diagnostic Test|SARS-CoV-2 testing on the Eppendorf Thermal Cycler PCR system using self-collected saliva as the specimen|Obtain self-collected saliva sample, perform SARS-CoV-2 testing using the Eppendorf Thermal Cycler Polymerase chain reaction (PCR) system on 30 samples associated with a positive and 30 samples associated with a negative NP sample, then compare saliva results to healthcare worker collected NP sample results evaluated on either the BioFire® FilmArray® Torch® system or the Cepheid® GeneXpert® (gold standard).
15781201|NCT04604132|Drug|Derazantinib|Derazantinib will be administered orally at a dose of 300 mg once a day as monotherapy.
15781202|NCT04604132|Drug|Derazantinib-paclitaxel-ramucirumab|"Derazantinib will be administered at the RP2D for derazantinib-paclitaxel-ramucirumab determined in Substudy 2 in combination with paclitaxel and ramucirumab.
~Paclitaxel will be administered intravenously at the RP2D for derazantinib-paclitaxel-ramucirumab determined in Substudy 2 on days 1, 8, and 15 of a 28-day cycle in combination with derazantinib and ramucirumab.
~Ramucirumab will be administered intravenously at the RP2D for derazantinib-paclitaxel-ramucirumab determined in Substudy 2 every 2 weeks in combination with derazantinib and paclitaxel."
15781203|NCT04604132|Drug|Derazantinib-atezolizumab|"Derazantinib will be administered orally at a dose of 300 mg once a day in combination with atezolizumab.
~Atezolizumab will be administered intravenously at a dose of 1200 mg every 3 weeks in combination with derazantinib."
15781204|NCT04604132|Drug|Paclitaxel-ramucirumab|"Paclitaxel will be administered intravenously at a dose of 80 mg/m² on days 1, 8, and 15 of a 28-day cycle in combination with ramucirumab.
~Ramucirumab will be administered intravenously at a dose of 8 mg/kg every 2 weeks in combination with paclitaxel."
15781205|NCT04604106|Diagnostic Test|Eyetracker|Eye-tracking is an objective, non-invasive method and particularly suited to assess neurodevelopmental outcome in infants.
15781206|NCT04604106|Diagnostic Test|Ages & Stages questionnaire|The Ages & Stages Questionnaire is a conventional instrument used to measure developmental outcome in infants.
15781207|NCT04604106|Diagnostic Test|Bayley Scale of Infant Development|The Bayley Scale of Infant Development is a conventional instrument used to measure developmental outcome in infants.
15781208|NCT04604093|Device|SMBG Meter|Self Monitoring Blood Glucose Meter
15781209|NCT04604093|Device|FreeStyle Libre 2 System|The Abbott's FreeStyle Libre 2 Flash Glucose Monitoring System
15781210|NCT04604080|Other|service of questionnaire|Respondents will be given a survey form only and after filling this will be collected back
15781211|NCT04604067|Drug|Acalabrutinib|"Cohort A: 6 cycles of acalabrutinib-R-CHOP
~Cohort B: 2 cycles of R-CHOP and 2 cycles of acalabrutinb-R-CHOP followed by 2 cycles of acalabrutinib single agent
~Cohort C: 4 cycles of R-CHOP followed by 2 cycles of rituximab single agent
~Cohort D: 6 cycles of R-CHOP
~Rituximab 375 mg/m2 IV Day 1, cyclophosphamide 750 mg/m2 IV Day 1, doxorubicin 50 mg/m2 IV Day 1, vincristine 1.4 mg/m2 (maximum 2 mg) IV Day 1; prednisone 100 mg PO d1-5; Acalabrutinib 100 mg BID Day 1-21, cycles repeated every 21 days"
15781212|NCT04604054|Drug|Granulocyte Colony Stimulated Factor|GCSF was intrauterine injected once at ovum pick up day
15781213|NCT04604054|Drug|Human Chorionic Gonadotropins|500 IU of HCG was injected intrauterine once at ovum pick up day
15781214|NCT04604041|Diagnostic Test|Neurophysiological techniques (TMS, EMNG), Immunological methods, Neuropsychological tests|In the newly diagnosed patients with relapsing-remitting MS will be evaluated with neurophysiological (TMS, EMNG), immunological (flow cytometry, ELISA) and neuropsychological tests before including standard medication treatment and in monitoring phases (5 weeks and 6 months after starting of medication treatment). Standard clinical evaluation (neurological and biochemical) will also be made parallel to neurophysiological, immunological and neuropsychological testing. MRI of the subject's brain will be performed prior to onset of medication treatment. Clinical biochemical, TMS, immunological and neuropsychological examinations will be performed on a single day, while clinical neurological examination, MRI, and EMNG will be performed the day before.
15781215|NCT04604028|Drug|Lenalidomide [Leavdo®]|Complete remission and partial remission rate
15781216|NCT04604015|Diagnostic Test|NeuralBot Investigational System|The NeuralBot Investigational System when used with the Lucid M1 System is a medical ultrasound device which assists the user in the setup and acquisition of cerebral blood flow velocity via the patient's temporal windows. It is intended for use as an adjunct to standard clinical practices for measuring and displaying cerebral blood flow velocity and the occurrence of transient emboli within the blood stream.
15781217|NCT04604002|Device|OCT Angiography|OCT Angiography offers clinicians a non-invasive three-dimensional visualization of vasculature in the retina and choroid. The visualization of perfused vasculature in a three-dimensional layout, offers clinicians an aid in the identification of retinal and choroidal pathologies such as retinal ischemia, microaneurysms, retinal neovascularization and choroidal neovascular membranes.
15781218|NCT04604002|Device|Color Fundus Photography|Non-contact white light photography
15781219|NCT04604002|Device|Optical Coherence Tomography|A non-contact test that uses light waves to take cross-sectional pictures of the retina
15781220|NCT04603989|Drug|HNC042 for Injection|HNC042,freeze-dried powder,multiple ascending doses, Intravenous route Multiple doses, daily for 7 days, doses: 300mg to 1200mg
15781221|NCT04603989|Drug|Placebo Comparator|Placebo , Intravenous route , multiple ascending doses
15781222|NCT04603976|Drug|Erenumab|Erenumab 70 mg or 140 mg packed in a SureClick® Autoinjector Pen (AI)
15781223|NCT04603963|Device|power breathe|respiratory muscle training 1 time a day with power breathe 3 sets of 10 repetitions
15781224|NCT04603950|Procedure|CACB+IPACK|continue adductor canal block plus Infiltration between the Popliteal Artery and Capsule of the Knee
15781225|NCT04603950|Procedure|CACB|continue adductor canal block
15781226|NCT04603937|Drug|KSI-301|Intravitreal Injection
15781227|NCT04603937|Drug|Aflibercept|Intravitreal Injection
15781228|NCT04603937|Other|Sham Procedure|The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
15781229|NCT04603924|Drug|Niclosamide|Niclosamide is an antihelmintic with in-vitro antiviral activity
15781230|NCT04603924|Drug|Placebo|Matching hydroxypropylmethylcellulose HPMC capsules with no active ingredients
15781231|NCT04603911|Drug|Liposomal bupivacaine|The liposomal bupivacaine used in the research study has been approved by the U.S. Food and Drug Administration (FDA) for use in humans for pain management. The specific approved uses are postsurgical single-dose wound infiltration analgesia and brachial plexus nerve block. In this study, we will be using liposomal bupivacaine in an additional way by infiltrating liposomal bupivacaine in a tissue plane to numb the nerves that provide sensation over the chest.
15781232|NCT04603911|Drug|Bupivacaine, epinephrine, dexamethasone, and clonidine|The medications that are typically administered as a solution in this block include bupivacaine, epinephrine, dexamethasone, and clonidine.
15781235|NCT04603885|Behavioral|Aerobic exercise program|A randomized controlled trial will be used to test the feasibility of a home-based exercise program to improve BDNF DNA demethylation among individuals with T2DM. A total of 42 participants will be randomized 2:1 to receive aerobic exercise intervention (n=28) or attention control (n=14) for 3 months. This ratio is used to offset an anticipated attrition imbalance across groups.
15781236|NCT04603885|Behavioral|Stretching exercise|stretching exercise
15781237|NCT04603872|Drug|CD19/BCMA Targeted CAR T-cells and dasatinib|Each subject receive CS1 Targeted CAR T-cells by intravenous infusion, and the dasatinib was combined according to the presumed regimens.
15781238|NCT04603872|Drug|CD19/BCMA Targeted CAR T-cells|Each subject receive CS1 Targeted CAR T-cells by intravenous infusion.
15781239|NCT04603859|Procedure|Elective induction of labor at 39 gestational weeks and 0 to 3 days|Elective induction of labor (eIOL) according to local policies
15781240|NCT04603846|Drug|anti-PD-L1 antibody|Patients will receive 16 cycles of anti-PD-L1 antibody 5mg/kg IV on day 1 every 3 weeks.
15781241|NCT04603846|Drug|albumin bound paclitaxel|Patients will receive 6 cycles of albumin bound paclitaxel 260mg/m2 on days 1 every 3 weeks .
15781242|NCT04603833|Drug|SHR3680+Docetaxel|Participants will receive SHR3680 combined with Docetaxel
15781243|NCT04603833|Drug|SHR3680|Participants will receive SHR3680
15781244|NCT04603833|Drug|Docetaxel|Participants will receive Docetaxel
15781245|NCT04603807|Drug|Entrectinib|Entrectinib will be self-administered orally at a dose of 600 mg (three 200 mg capsules per day) once daily with or without food.
15781246|NCT04603807|Drug|Crizotinib|Crizotinib will be self-administered orally at a dose of 250 mg twice daily with or without food.
15781247|NCT04603794|Drug|0.5% Povidone Iodine|Commercially Available Mouth Rinses and Over the Counter Standard Formulations
15781248|NCT04603794|Drug|0.12% Chlorhexidine Gluconate Mouth Rinse|Commercially Available Mouth Rinses
15781249|NCT04603794|Drug|1% Hydrogen Peroxide|Commercially Available Over the Counter Standard Formulations USP (United States Pharmacopeia)
15781250|NCT04603794|Drug|0.9% Normal Saline|Commercially Available Over the Counter Standard Formulations USP (United States Pharmacopeia)
15781251|NCT04603781|Dietary Supplement|CBD Isolate|300 mg. daily dose of CBD Isolate Oil
15781252|NCT04603781|Dietary Supplement|Full Spectrum CBD Oil|300 mg. daily dose of CBD with full spectrum of other cannabinoids found in the hemp plant
15781253|NCT04603781|Dietary Supplement|Broad-Spectrum CBD Oil|300 mg. daily dose of CBD with a selected spectrum of other cannabinoids found in the hemp plant
15781254|NCT04603781|Dietary Supplement|Placebo Oil|MCT Oil with mint flavoring
15781255|NCT04603768|Other|Theraband exercises|Group A performed theraband exercises for 6 weeks.In the first 2 weeks theraband with low resistance was used to perform exercises and then we proceeded gradually with higher resistance therabands.Theraband exercises was performed for Shoulder Flexion,Shoulder Extension Strengthening, Shoulder Internal Rotation Strengthening, Shoulder External Rotation Strengthening, Shoulder Abduction, Empty Can Exercise & Rowing Exercise with 8-10 reps, 3sec hold and 2-3 sets With each of these exercises
15781256|NCT04603768|Other|Co-contraction exercises|"Muscle co-contraction is the simultaneous contraction of the muscles acting around a joint. Subject stood upright & contracted both the groups (agonist and antagonist) simultaneously without bringing movement at shoulder joint with 6-8 reps , 3sets & 5- 15 seconds duration of sustained self-arm bracing or stiffening was maintained.
~On eligible participants baseline assessment was done,3 session were given 3days per week, post intervention assessment was taken at 3rd and 6th week"
15781257|NCT04603768|Other|Isometric exercises|"Isometric exercises of shoulder were performed in subjects for 6 weeks which included isometric Shoulder flexion, shoulder abduction isometric exercise, isometric shoulder external rotation, isometric shoulder internal rotation & isometric shoulder extension with 8-10 reps, 5 sec hold and 2 sets.
~On eligible participants baseline assessment was done,3 session were given 3days per week, post intervention assessment was taken at 3rd and 6th week"
15781258|NCT04603755|Device|Electrical Impedance tomography|Electrical Impedance tomography recording during 5 minutes every day during 7 days
15781259|NCT04603742|Drug|Anakinra|100 mg of Anakinra will be mixed with 100 mL of 0.9% saline solution for IV administration.
15781260|NCT04603742|Drug|0.9% Saline|The placebo preparation will consist of a 100 mL of 0.9% saline solution without the addition of anakinra.
15781261|NCT04603729|Drug|Dexamethasone 2 MG/ML|Dexamethasone 8mg/day will be given intravenous for 5 days to group 1 participants
15781262|NCT04603729|Drug|Methylprednisolone Injection|methylprednisolone 1mg/kg/day will be given intravenous for 5 days to group 2 participants
15781263|NCT04603716|Other|Eccentric Muscle Energy Technique|"Conventional Treatment given to both groups (Hot pack for 15 minutes, Mobilization, AROM Exercises 10 sets x 3days in a week)
~Reciprocal inhibition of target muscle (i.e. levator scapulae ,pectoralis major, upper trapezius) causing relaxation, patient force is minimal towards maximal therapist force, 5-7 repetition for 2-4seconds 3 days in a week up to 6 weeks.
~Muscle is taken from shortened to lengthened position."
15781264|NCT04603716|Other|Concentric muscle energy technique|"Group B: Concentric Muscle Energy Technique: (Autogenic inhibition of target muscle (i.e. levator scapulae ,pectoralis major, upper trapezius) patient force is greater than therapist force, 5-7repitition for 3-4seconds)Muscle is taken from lengthened to shortened position.
~On eligible participants baseline assessment was done,3 session were given 3days per week, post intervention assessment was taken at 1st 3rd and 6th week"
15781265|NCT04603703|Other|HVLAT Manipulation|"Ultrasound for 10 mins/1 set/ (3 days/ week), Moist hot pack for 10 mins/1 set/ (3 days/ week), Piriformis stretching for 7 sec hold/ 7 repititions/ 1 set/ (3 days/ week), Myofascial release of lumbosacral paraspinal muscles for 3 mins/ 1 set/ (3 days/ week), Gluteal muscles strengthening for 10 sec hold/ 5 reps/ 1 set/ (3 days/ week), Sciatic Neurodynamics with 10 oscillations/ 3 sets/(3 days/ week), HVLAT manipulation/ 1 rep/ 1set/ (3 days/ week),
~A total of 2 weeks (6 sessions, 3 sessions/ week) were given each consisting of 30 mins."
15781266|NCT04603703|Other|Conventional Physical Therapy|"Ultrasound for 10 mins/1 set/ (3 days/ week), Moist hot pack for 10 mins/1 set/ (3 days/ week), Piriformis stretching for 7 sec hold/ 7 repititions/ 1 set/ (3 days/ week), Myofascial release of lumbosacral paraspinal muscles for 3 mins/ 1 set/ (3 days/ week), Gluteal muscles strengthening for 10 sec hold/ 5 reps/ 1 set/ (3 days/ week), Sciatic Neurodynamics with 10 oscillations/ 3 sets/(3 days/ week),
~A total of 2 weeks (6 sessions, 3 sessions/ week) were given each consisting of 30 mins."
15781267|NCT04603690|Drug|Colchicine|1 mg tablet
15781268|NCT04603664|Diagnostic Test|serum NGAL and cystatin c|measuring serum NGAL and cystatin c on admission and after 48 hours in critically ill patients with covid 19 then compare results to serum creatinine and signs of acute kidney injury
15781270|NCT04603638|Drug|Magnesium|40 mg/kg(peroperative), 40 mg/kg (postoperative 12 h)
15781271|NCT04603638|Drug|Isotonic|100 ml
15781272|NCT04603625|Other|postural management|postural management in sitting position
15781273|NCT04603612|Procedure|Primary TURBT|"As shown in (Fig. 1), all patients will be thoroughly evaluated by medical history and physical exam, laboratory investigations, abdominal pelvic ultrasound (US). Then, all patients will be managed by cystoscopy and initial complete TURBT. Patients with benign pathology, non-urothelial carcinoma or muscle invasive disease, will be excluded from the study.
~After 4-6 weeks, eligible patients will be appointed for repeat resection TURBT."
15781274|NCT04603599|Diagnostic Test|serum soluble L1CAM (sL1CAM)|blood sample
15781275|NCT04603586|Radiation|SBRT|SBRT: in 5-6 fractions with CyberKnife
15781276|NCT04603586|Drug|Chemotherapy|1000 mg of Gemcitabine + albumin-bound paclitaxel per square meter of body surface area on days 1, 8 for 2 weeks, followed by 1 weeks of rest as one course
15781277|NCT04603573|Device|fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride )|5% Sodium Fluoride Varnish is a fluoride varnish which is applied to tooth surfaces for sealing dentinal tubules and treatment of hypersensitive teeth. The varnish is applied in a thin layer over the tooth with an applicator brush, and moisture from saliva cures the varnish for adhesion to the tooth surface.
15781278|NCT04603573|Device|Resin based fissure sealant (3M Clinpro sealant )|"teeth will be isolated with coton rolls and saliva ejector then etching for pits and fissure then tooth will be washed then apply resin based fissure sealant on occlusal surface.
~resin fissure sealant is a more sensitive for saliva."
15781279|NCT04603560|Behavioral|Audit and Feedback|A report of the provider's hypertension control rates compared to benchmark will be displayed using principles of social norming. We will present that provider's hypertension control rates compared to the 90th percentile of their peers.
15781280|NCT04603560|Behavioral|Pharmacist E-Detailing|A pharmacist will review the chart in advance and provide a personalized recommendation for how to intensify the specific patient's antihypertensive regimen based on current guidelines. For example, they might recommend adding an additional medication based on the patient's comorbid conditions and could suggest a starting dose and timeframe for dose escalation.
15781281|NCT04603547|Device|Transcutaneous Carbon Dioxide Monitoring|Once an infant is identified as being eligible for TH treatment and hypothermia was initiated according to the department clinical practice guidelines, and written informed consent was obtained from one of the parents, tcPCO2 monitoring can be started. Transcutaneous CO2 will be measured by SenTec Digital Monitor (software version SW-V07.00; MPB SW-V05.00.12) with V-Sign™ Sensor (SenTec AG, Thervil, Switzerland). Also, we will use small blood samples (0.2 ml) from clinical blood draws up to 4 times following starting transcutaneous CO2 monitoring for measuring blood gas for research purposes.
15781282|NCT04603534|Other|Aged Simulation Suit|The aged simulation suit (Sakamoto Model M716, Tokyo, Japan) will be worn by students. The simulation suit consist of a several items such as loads, a soft material band with Velcro, glasses, ear plugs, gloves, belts and a cane. All the items are need to simulate one's posture just like in elderly person. Small, medium and large sizes of suits are provided by the company thereby each suit is suitable for each student related to their wearing size. Prior to this study, a total of three sets of suits will be gathered. Then, each student will perform each pre-defined scenarios step by step after the suit is worn. During the activities no help or leading will be given to the students. However, one of the researchers will supervise the students during the activities so that to integrate a safe platform. In addition, each student will be informed that if he/she can terminate the activity whenever it is required.
15781283|NCT04603508|Drug|BERLIM 25/10 association|Berlim 25/10 association coated tablet.
15781284|NCT04603508|Drug|EMPAGLIFLOZIN|Empagliflozin 25 mg coated tablet.
15781285|NCT04603508|Drug|ROSUVASTATIN CALCIUM|Rosuvastatin 10 mg coated tablet.
15781286|NCT04603508|Other|BERLIM 25/10 ASSOCIATION PLACEBO|Berlim 25/10 association placebo coated tablet.
15781287|NCT04603508|Other|EMPAGLIFLOZIN PLACEBO|Empagliflozin placebo coated tablet.
15781288|NCT04603508|Other|ROSUVASTATIN CALCIUM PLACEBO|Rosuvastatin placebo coated tablet.
15781657|NCT04600310|Device|No Intervention|Conventional skin preparation technique
15781292|NCT04603482|Behavioral|Resourcefulness Training|A cognitive-behavioral intervention presented within an audiovisual format that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
15781293|NCT04603482|Behavioral|Biofeedback Training|"Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate feedback to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior."
15781294|NCT04603482|Behavioral|Diversional Activites|An audiovisual format presenting 12 activities for adults including but not limited; crossword puzzles, reading, gardening, exercise, cooking/baking, board games, learning a new language, social activities, online games, etc.
15781295|NCT04603469|Other|Non invasive blood pressure|measurement of blood pressure during induction of general anesthesia
15781296|NCT04603456|Drug|Lacteol fort|Lacteol fort is a drug containing lactobacilli
15781297|NCT04603456|Drug|Standardized Timothy Grass Pollen|SLIT includes 2 phases build up and maintenance phases. (Jubilant HollisterStier LLC 14110 Collections Drive, Chicago USA) .
15781298|NCT04603456|Drug|Lacteol fort and Standardized Timothy Grass Pollen|Lacteol fort is a drug containing lactobacilli and the Standardized Timothy Grass Pollen includes 2 phases build up and maintenance phases.
15781299|NCT04603443|Dietary Supplement|Branched Chain Amino Acids|Isoleucine, Leucine, and Valine
15781300|NCT04603443|Dietary Supplement|Branched Chain Amino Acids|Isoleucine, Leucine, and Valine, 20 g BID x 12 weeks
15781301|NCT04603443|Dietary Supplement|Branched Chain Amino Acids|Isoleucine, Leucine, and Valine, 30 g BID x 12 weeks
15781302|NCT04603443|Dietary Supplement|Protein Control|Protein placebo control - all amino acids except for BCAA, 30 g BID x 12 weeks
15781303|NCT04603430|Other|Participation in a community wellness program|Participation in the STEPS program, a physical therapy student-run community wellness program for local seniors.
15781304|NCT04603417|Diagnostic Test|Electroencephalography (EEG)/Magnetoencephalography (MEG)/MRI|This cross-sectional study will present the participants with an instrumental pain avoidance learning task, while we record continuous Magnetoencephalography (MEG) brain signals, and other autonomic measurements. All patients will complete behavioral, neuropsychological and pain assessments to rate their current pain, disability, fear, anxiety, and depression using standardized scales.
15781305|NCT04603391|Drug|di-Methylphenidate plus Cannabidiol|Subjects will be administered one (1) 10 mg tablet of dl-methylphenidate (Ritalin®) plus CBD 750 mg (administered as 7.5 ml of Epidiolex® solution [100 mg/ml] of CBD)
15781306|NCT04603391|Drug|di-Methylphenidate plus Cannabidiol Placebo solution|Subjects will be administered one (1) 10 mg tablet of dl-methylphenidate (Ritalin®) 7.5 ml of Epidiolex® placebo solution containing no CBD.
15781307|NCT04603378|Other|KB195|KB195 is a novel glycan
15781308|NCT04603378|Other|Polydextrose|Polydextrose is an oligosaccharide
15781309|NCT04603378|Other|Pullulan|Pullulan is an oligosaccharide
15781310|NCT04603378|Other|Maltodextrin|Maltodextrin is a digestible carbohydrate
15781313|NCT04603352|Other|Hip Helpers home program|Home program: Infants will wear Hip Helpers 30 minutes, twice per day.
15781314|NCT04603339|Other|Multidisciplinary rehabilitation programme delivered via telehealth|"12 week programme of;
~1) Physiotherapy led aerobic and resistance exercise 2)1:1 Dietetics Counselling 3) Group Multidisciplinary Education Sessions"
15781315|NCT04603326|Procedure|Lumbar Puncture|Lumbar Puncture for collection of Cerebrospinal Fluids
15781316|NCT04603313|Other|tele-advice system|The intervention consists of setting up in each participating center an infectious disease tele-advice system available to general practitioners via a dedicated mobile telephone line.
15781317|NCT04603300|Drug|INT301|INT301 is an allergy immunotherapy delivered in the form of a fully functional toothpaste
15781318|NCT04603300|Drug|Placebo|Fully functional toothpaste containing no immunotherapy agents
15781319|NCT04603287|Drug|SI-B001|Administration by intravenous infusion.
15781320|NCT04603274|Procedure|8 sessions of electroacupuncture to the upper limb with carpal tunnel syndrome|All participants will accept 8 sessions of electroacupuncture, 2 days a week for 1 month by experienced physicians. Acupuncture sterile disposable needles 0,25x 0,25 mm will be inserted for 20 minutes at specific acupuncture points to all patients. Electrical stimulation will be applied at specific acupuncture points for 20 minutes.
15781321|NCT04603261|Diagnostic Test|Contrast concentration in urine|"Iodinated contrast content of urine samples, collected post-contrast over a period of 5 days at all times of natural excretion within that period, will be assayed.
~Serum creatinine will be measured daily before (day 0) and during 5 days post-contrast, and again at 1 month post-contrast."
15781322|NCT04603248|Drug|Nivolumab|Nivolumab 3mg/kg treatment will be given every 2 weeks up to progression or unacceptable toxicity
15781323|NCT04603235|Behavioral|Manual-based Art Therapy|This is a manual-based treatment and consists of 10 one-hour weekly sessions. The treatment consist of detailed guidelines based on phenomenological art therapy. The sessions follow the same structure: Introduction, short relaxation, art-making, reflections about the image, and conclusions. Examples of comprised art tasks; lifeline, emotional scribbles, and different roles. The art tasks served as a prompt for painting.
15781324|NCT04603222|Device|SUMMIT BRUSH|SUMMIT BRUSH used for the treatment of blepharitis
15781325|NCT04603222|Other|Ocusoft Lid Scrub Original Foaming Eyelid Cleanser|treating blepharitis with Ocusoft Lid Scrub Original Foaming Eyelid Cleanser
15781326|NCT04603209|Radiation|Intraoperative Radiation Therapy (IORT)|IORT involving 50kV Xrays to a dose of 20 Gy during breast-conserving surgery
15781327|NCT04603183|Drug|Abemaciclib|Patients will receive abemaciclib 150 mg orally twice daily (BID) (300 mg daily, administered as six 50 mg tablets) during each 28 day cycle combined with either letrozole or fulvestrant.
15781328|NCT04603183|Drug|Paclitaxel|Paclitaxel 90 mg/m² infused over 1 hour on Days 1, 8, and 15 of the 28 day cycle, with at least a 6-day time span between separated doses.
15781329|NCT04603183|Drug|Letrozole|Patients will receive 2.5 mg letrozole, orally administered and taken daily during each 28-day cycle combined with abemaciclib.
15781330|NCT04603183|Drug|Fulvestrant|Patients will receive 500 mg fulvestrant, by intramuscular [IM] administration on Days 1 and 15 (±3 days) of the first treatment cycle and Day 1 of each cycle thereafter combined with abemaciclib.
15781331|NCT04603170|Other|DRUG|taking drug medication prescribed by psychiatrists for at least one month
15781333|NCT04603131|Biological|Inactivated Chikungunya virus vaccine 20 mcg|3 doses of Inactivated Chikungunya virus vaccine (BBV87) administered intramuscularly on Day 0, 29 and 57
15781334|NCT04603131|Biological|Inactivated Chikungunya virus vaccine 30 mcg|3 doses of Inactivated Chikungunya virus vaccine (BBV87) administered intramuscularly on Day 0, 29 and 57
15781335|NCT04603131|Biological|Inactivated Chikungunya virus vaccine 10 mcg|3 doses of Inactivated Chikungunya virus vaccine (BBV87) administered intramuscularly on Day 0, 29 and 57
15781336|NCT04603131|Biological|Placebo|3 doses of Placebo administered intramuscularly on Day 0, 29 and 57
15781337|NCT04603118|Procedure|Optic ultrasonography|
15781338|NCT04603118|Procedure|Lumbar puncture|
15781339|NCT04603092|Behavioral|Digital Health Literacy Intervention|"Willing women participants will be provided equipment with instructions for the intervention, including a smartphone and a 4G Wifi gadget. The health literacy intervention, delivered to the experiment group, will last three months and will include a combination of the following four components:
~Component 1: Health literacy video tutorial. Component 2: Virtual one-on-one weekly meetings. Component 3: Monthly group virtual meetings and Whatsapp group. Component 4: Provision and guidance of a self-management chart."
15781340|NCT04603079|Behavioral|Intervention for COVID-19 preventive protocols|The intervention will comprise (A) digital communication of written material and (B) monthly online training and discussion through skype and zoom, to allow for physical demonstrations, Q&A and sharing of challenges. The five specific areas covered in the intervention for COVID-19 preventive protocols will include: (1) PPE fitting, (2) PPE removal, (3) hand hygiene, (4) cleaning, disinfection and sterilization, and (5) nurse uniform sterilization.
15781341|NCT04603066|Drug|Ondansetron 16 mg with Tariquidar|In randomized order, each participant will receive two IV infusions of ondansetron, 3 weeks apart; one with placebo (D5W), and one with tariquidar (4mg/kg dose in D5W) administered IV over 60 minutes. Ondansetron will be diluted in 100mL 0.9% normal saline, and tariquidar will be diluted in 500mL D5W.
15781342|NCT04603066|Drug|Ondansetron 16 mg with Placebo|In randomized order, each participant will receive two IV infusions of ondansetron, 3 weeks apart; one with placebo (D5W), and one with tariquidar (4mg/kg dose in D5W) administered IV over 60 minutes. Ondansetron will be diluted in 100mL 0.9% normal saline, and tariquidar will be diluted in 500mL D5W.
15781343|NCT04603053|Behavioral|mHealth app|Participants will receive access to CBot-A app for 12 weeks.
15781344|NCT04603040|Drug|Toripalimab|"Experimental group:
~Toripalimab, 240mg, IV infusion, every 3 weeks (q3w), In a cycle of 3 weeks (21 days), until occurrence of termination event specified in the protocol."
15781345|NCT04603027|Drug|EDP1815|EDP1815 is an orally administered, pharmaceutical preparation of a single strain of bacteria
15781346|NCT04603027|Drug|Placebo|Placebo oral capsule
15781347|NCT04603014|Combination Product|Interdialytic peritoneal ultrafiltration with 10% dextrose solution|Interdialytic peritoneal ultrafiltration with incremental doses of a 10% dextrose solution, after hemodialysis twice weekly for three consecutive weeks
15781348|NCT04603001|Drug|LY3410738|Oral LY3410738
15781349|NCT04602988|Device|EEG|EEG monitoring of brain rhythms
15781356|NCT04602962|Procedure|fertility preservation, several methods|fertility preservation using assisted reproductive techniques or not
15781357|NCT04602949|Diagnostic Test|Breath Biopsy Analysis|Analysis of a single breath Biopsy
15781358|NCT04602936|Drug|Solriamfetol|Solriamfetol is a novel DNRI (novel dopamine and norepinephrine reuptake inhibitor) that has recently received regulatory approval for the treatment of excessive daytime sleepiness in individuals with narcolepsy or obstructive sleep apnea.
15781359|NCT04602936|Drug|Placebo|"A placebo is a substance or treatment which is designed to have no therapeutic value (an inactive compound, i.e. inert, often called a sugar pill)."
15781360|NCT04602923|Diagnostic Test|Corneal topography: OPD-Scan|Corneal topography photography, taken by specular reflection (OPD-Scan) by measuring corneal curvature, thickness and topography.
15781361|NCT04602923|Diagnostic Test|Corneal topography: Pentacam|Corneal topography photography, taken by Scheimpflug imaging (Pentacam) by measuring corneal curvature, thickness and topography.
15781362|NCT04602910|Device|a web-based shared decision-making tool|Five major parts were developed with the use of the action research approach. The Introduction and Options (parts 1 and 2) describe the severity of the cancer treatment and infertility and the knowledge of fertility preservation, respectively. The SDM tool was designed as a step by step process (part 3) that involves the comparison of options, patient's values and preferences, their knowledge regarding infertility and options, and reaching a collective decision. The Resources (part 4) provide information on the hospitals that provide such services, and the References (part 5) list all the literature cited in the website. The results show the web-based SDM meets both the patients' and health providers' needs and helps reproductive-age patients with breast cancer make decisions on fertility preservation.
15781363|NCT04602897|Other|forced coughing|The cough group patients were asked to cough a forced cough during different steps of IUD insertion
15781435|NCT04602221|Drug|BI 425809|Film-coated tablet
15781364|NCT04602884|Diagnostic Test|Breath biopsy sampling using the ReCIVA Breath Sampler|Breath biopsy sampling using the ReCIVA Breath Sampler
15781365|NCT04602871|Diagnostic Test|Breath Biopsy|Breath Biopsy sampling using the ReCIVA® Breath Sampler
15781366|NCT04602858|Device|Reactive Balance Training|Reactive balance training involves the use of the Trip and Slip walkway that is able to expose participants to unpredictable trips and slips. Trips and slips will occur at random location on the walkway and times within the gait cycle, with the participants receiving 3-monthly retraining sessions along with an educational booklet.
15781367|NCT04602858|Other|Control|The control intervention will be receiving an educational booklet as part of standard care. The education component will target a variety of fall risk factors and provide strategies to mitigate these risk factors.
15781372|NCT04602832|Other|Enduring Happiness and Continued Self-Enhancement (ENHANCE) for COVID-19|ENHANCE is a 12-session program designed to help improve subjective well-being, especially through the challenges of a pandemic. The ENHANCE program introduces and teaches people about the evidence-based principles and skills that have been shown across decades of research to improve overall health and well-being.
15781373|NCT04602819|Device|PicoSure 755nm picosecond alexandrite laser with diffractive lens|Understand the role of 755nm picosecond alexandrite laser with diffractive lens of reversal of photodamage and improving the melasma by evaluation with optical coherence tomography and other noninvasive methods.
15781374|NCT04602819|Device|ApolloVue® S100 Image System|Understand the role of 755nm picosecond alexandrite laser with diffractive lens of reversal of photodamage and improving the melasma by evaluation with optical coherence tomography.
15781375|NCT04602819|Device|Cutometer® dual MPA 580|Understand the role of 755nm picosecond alexandrite laser with diffractive lens of reversal of photodamage and improving the melasma by evaluation with the Cutometer® dual MPA 580.
15781376|NCT04602819|Device|VISIA®|Understand the role of 755nm picosecond alexandrite laser with diffractive lens of reversal of photodamage and improving the melasma by evaluation with the VISIA®.
15781377|NCT04602793|Diagnostic Test|ultrasonography|All ultrasonographic examinations were performed by a single physiatrist experienced in musculoskeletal sonography. The full course of the sciatic nerve (SN), tibial nerve (TN), and common peroneal nerve (CPN) was assessed in a craniocaudal direction starting from the subgluteal fold to the popliteal fossa. The probe was placed axially on the nerves (perpendicular to the nerve) and the cross-sectional area (CSA) was measured at the same level proximal to the bifurcation for the SN , and at a point distal to the bifurcation of the SN for the TN and CPN (Figure 2). The values from the normal sides were accepted as controls.
15781378|NCT04602767|Drug|Vasopressin|Vasopressin titrated 0.01 U/min up to 0.04 U/min for MAP < 65 mmHg
15781379|NCT04602767|Drug|Phenylephrine|Phenylephrine titrated 0.25 mcg/kg/min up to 1.0 mcg/kg/min for MAP < 65 mmHg
15781380|NCT04602754|Drug|BERLIM 25/20 ASSOCIATION|Berlim 25/20 association coated tablet.
15781381|NCT04602754|Other|EMPAGLIFLOZIN PLACEBO|Empagliflozin placebo coated tablet.
15781382|NCT04602754|Other|ROSUVASTATIN CALCIUM PLACEBO|Rosuvastatin calcium placebo coated tablet.
15781383|NCT04602754|Drug|EMPAGLIFLOZIN|Empagliflozin 25 mg coated tablet.
15781384|NCT04602754|Drug|ROSUVASTATIN CALCIUM|Rosuvastatin 20 mg coated tablet.
15781385|NCT04602754|Other|BERLIM 25/20 ASSOCIATION PLACEBO|Berlim 25/20 association placebo coated tablet.
15781386|NCT04602741|Behavioral|A4i Intervention|6 months of the provision of A4i on the individual's own device.
15781387|NCT04602728|Behavioral|Back2Life|The Back2Life intervention uses an adaptive treatment approach with module-based treatment sessions selected on the basis of baseline assessment (rather than a fixed treatment approach) to allow flexibility in tailoring treatment components to meet individual family needs. All youth participants will receive the standard 6-session pain coping skills training program, consisting of learning ways to cope with and manage chronic sickle cell pain. The standard program includes topics that were identified by young people with chronic sickle cell pain and their parents as important skills for all youth with chronic pain and sickle cell disease. In addition to the standard 6-session program, youth participants may receive an additional 1 to 4 sessions that may help with specific problems and/or co-morbidities related to pain. At least one parent or guardian is required to attend the sessions with their child.
15781388|NCT04602715|Drug|MET-2|Subjects will take capsules containing MET-2 daily during the trial. There will be a loading dose at the start of dosing, and a daily dose. There will be a booster dose given at week 2 and a second booster dose taken at week 4 for those subjects who have not improved by that time.
15781389|NCT04602715|Drug|Placebo|Placebo Control
15781390|NCT04602689|Drug|Human fibrinogen concentrate|Spread the Human fibrinogen concentrate/Aprotinin/Thrombin/Calcium chloride hydrate mixture on iatrogenic ulcer after ESD
15781391|NCT04602676|Diagnostic Test|Rehydration calculator application with DEP algorithm|4 week period where clinicians will use a rehydration calculator application with the DEP algorithm followed by a 1 week washout period.
15781392|NCT04602676|Diagnostic Test|Rehydration calculator application|4 week period where clinicians will use a rehydration calculator application without the DEP algorithm followed by a 1 week washout period.
15781393|NCT04602663|Device|Esophageal Variceal Band ligation|Band ligation of OV
15781394|NCT04602637|Other|Training load|Monitoring training load during covid
15781395|NCT04602624|Drug|SAGE-718|SAGE-718 oral tablets.
15781397|NCT04602598|Drug|Zanubrutinib 80 MG|Zanubrutinib 80 MG for 24 weeks
15781398|NCT04602585|Behavioral|Psycho-education|Participants will receive 6 psycho-education sessions as adjunct therapy to the use of antipsychotics
15781399|NCT04602572|Behavioral|Lifestyle course.|Pharmacotherapy
15781400|NCT04602572|Procedure|Bariatric surgery.|Sleeve gastrectomy or gastric bypass.
15781458|NCT04602065|Drug|IBI318(Recombinant human anti-PD1/PD-L1 bispecific antibody)|IBI318, 300mg, Q2W, Intravenous influsion.
15781401|NCT04602559|Device|MOBIDERM Panty group|"In the MOBIDERM Panty group, patients wear the MOBIDERM Panty during day and night for 3 months with the possibility to add the PAD.
~The protocol includes 3 visits.
~Visit 1 at day 0, corresponding to the inclusion visit, includes device delivery and some clinical evaluations (clinical examination, characteristics of lymphedema, self questionnaires, pain assessment, perimeter data).
~Visit 2 at 30 days after the inclusion : includes some clinical evaluations (clinical examination, characteristics and evolution of lymphedema, self questionnaires, pain assessment, perimeter data, safety, compliance).
~Visit 3 at 90 days after the inclusion : includes some clinical evaluations (clinical examination, characteristics and evolution of lymphedema, self questionnaires, pain assessment, perimeter data, safety, compliance)."
15781402|NCT04602546|Device|BIS Complete Monitoring System|The BIS™ EEG complete monitoring system is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use. The system and its associated parameters are intended for use on adult patients within a hospital or medical facility, providing patient care to monitor the state of the brain by data acquisition of EEG signals.
15781403|NCT04602533|Drug|Durvalumab|Induction phase: Durvalumab (1500 mg once every 3 weeks) for 4-6 cycles in combination with standard of care (Radiochemotherap) Maintenance phase: Durvalumab (1500 mg once every 4 weeks) until PD or unacceptable toxicities.
15781404|NCT04602533|Drug|standard of care|Radiochemotherapy: Cisplatin (75 mg/m² (BSA) D1) and Etoposide (100 mg/m² (BSA) D1-3) once every 3 weeks for 4-6 cycles and concomitant Radiotherapy (60±6 Gy, 2 Gy/d) followed by prophylactic cranial irradiation (PCI, if clinically indicated and according to local standard))
15781405|NCT04602520|Behavioral|3 Wishes Project|Behavioral: Focused conversations at end-of-life to promote the connections between patients, family members, and clinicians.
15781406|NCT04602507|Drug|Ivermectin|Routinary care offered in the hospital plus ivermectin 400 µg/kg (2 drops per kg) orally in a single dose.
15781407|NCT04602507|Other|Placebo|Routinary care offered in the hospital plus placebo (2 drops per kg) orally in a single dose
15781408|NCT04602494|Drug|Varenicline|varenicline: 0.5 mg once daily on days 1-3, 0.5 mg twice daily on days 4-7 and starting on day 8, 1 mg twice daily for a total of 12 weeks
15781409|NCT04602494|Drug|Placebo|Identical placebo: 0.5 mg once daily on days 1-3, 0.5 mg twice daily on days 4-7 and starting on day 8, 1 mg twice daily for a total of 12 weeks
15781410|NCT04602468|Drug|Kaftrio|The intervention is the same for both study groups. In addition to all the assessments in the standard arm, the advanced arm subjects will undergo spirometry controlled CT, nasal lavage and sputum sample collection.
15781411|NCT04602455|Behavioral|Self-Care Program through Heartfulness|A four-week Self-Care program through Heartfulness will be offered to participants in the Heartfulness group. This would include a daily practice of relaxation tools for 15 minutes a day using an app and once a week webinar for 30 minutes. Guided relaxation and meditation sessions will be offered to the participants during the intervention weeks. These virtual sessions were conducted by Heartfulness Champions and certified trainers from Heartfulness Institute.
15781412|NCT04602442|Drug|EXO 1 inhalation|Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10^10 of nanoparticles (exosomes) of the first type.
15781413|NCT04602442|Drug|EXO 2 inhalation|Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10^10 of nanoparticles (exosomes) of the second type.
15781414|NCT04602442|Drug|Placebo inhalation|Twice a day during 10 days inhalation of 3 ml special solution free of nanoparticles (exosomes).
15781415|NCT04602416|Behavioral|Training sessions|
15781416|NCT04602403|Procedure|rigid ureteroscopy|endoscopic treatment of ureteric stones by extraction or peumatic desintegration or laser
15781417|NCT04602390|Drug|ANK-700|Intravenous (IV) infusion
15781418|NCT04602390|Drug|Placebo|Intravenous (IV) infusion
15781419|NCT04602377|Drug|Pembrolizumab 25 MG/ML [Keytruda]|"Pembrolizumab (200mg flat dose) will be administred in combinaison with PAVEP chemotherapy for the first 6 cycles (21-day cycle)
~Then, Pembrolizumab (200mg flat dose) will be administred in monotherapy until one year for patients with complete response and up to two years for patients with Stable disease or Progression response after the end of first-sequence therapy (PAVEP chemotherapy +/- High dose chemotherapy) or until disease progression."
15781420|NCT04602351|Behavioral|Communication|policies on communication and informed consent in ICU
15781421|NCT04602312|Other|Meditation (1 x 20-minute guided audio training)|Participants will complete a single session of 20-minutes online guided audio-delivered training session of one of the four conditions.
15781422|NCT04602299|Other|Set the minimum time of gastroscopy|This study contains 2 stages. At the first stage, no interventions are implemented. The researchers just observe the actual procedure time of gastroscopy. At the second stage, a minimal procedure time is set based on the observational results of the first stage.
15781423|NCT04602286|Other|Meditation (1 x 20-minute guided audio training)|Participants will complete a single session of 20-minutes online guided audio-delivered training session of one of the four conditions.
15781424|NCT04602273|Drug|Azacitidine Injection [Vidaza]|
15781425|NCT04602247|Dietary Supplement|SIC|Sodium Iron Chlorophyllin, whose bioavailability is to be studied
15781426|NCT04602247|Dietary Supplement|SIC + AA combined|Sodium Iron Chlorophyllin and ascorbic acid. The ascorbic acid should not have an effect on Sodium Iron Chlorophyllin
15781427|NCT04602247|Dietary Supplement|FeSO4|Ferrous sulfate serves as a positive control, whose iron bioavailability is known
15781428|NCT04602247|Dietary Supplement|FeSO4 + AA combined|Ferrous sulfate serves as a positive control and the addition of ascorbic acid, further enhances its bioavailability
15781429|NCT04602247|Other|EP + FeSO4 combined|Chlorophyllin with an empty porphyrin ring, given along with FeSO4 to study if there is an incorporation of Fe into the porphyrin ring as it passes the gastric system
15781430|NCT04602247|Other|EP + FeSO4 + AA combined|Chlorophyllin with an empty porphyrin ring, given along with FeSO4 to study if there is an incorporation of Fe into the porphyrin ring as it passes the gastric system. Ascorbic acid is given along with the intervention to see if there is any difference in the fractional iron absorption when compared to EP+ FeSO4
15781431|NCT04602234|Diagnostic Test|Lung ultrasonography|Investigators performed lung ultrasonography on patients
15781432|NCT04602221|Drug|Lamotrigine|Tablet
15781433|NCT04602221|Drug|BI 409306|Film-coated tablet
15781434|NCT04602221|Drug|Placebo|Tablet, Film-coated tablet
15781436|NCT04602208|Procedure|Retrospectively review of medical data in patients treated by focal HIFU for primary localized prostate cancer|This study concern the patients with localized prostate cancer treated by Focal HIFU for low or intermediate risk disease. Three surgeons experienced in HIFU performed the procedures. Patients were treated with the Ablatherm device [EDAP TMS S.A., Vaulx-en-Velin, France] until July 2013 and then with the Focal-One device [EDAP TMS S.A.]. The data of all the patients treated between November 2009 to December 2016, at Edouard Herriot Hospital (Lyon, France), were prospectively maintain within a central database and retrospectively reviewed. The study primary outcome was retreatment-free survival (RFS) defined as any additional further treatment: local (FT/PGA for in-field or out-of-field recurrences or radical prostatectomy or external beam radiotherapy or whole gland HIFU) or systemic salvage treatment, a positive biopsy revealing PCa with an ISUP grade≥ 2 in nontreated patients, PCa metastasis or PCa specific death. The adverse events and functional outcomes were also evaluated.
15781437|NCT04602182|Procedure|music therapy intervention|Patients will receive a daily music therapy intervention from the beginning until the end of the weaning from mechical ventilation.
15781438|NCT04602169|Procedure|PVI|PV re-isolation will be conducted according to the CLOSE-protocol. Point-by-point radiofrequency (RF) delivery will be performed aiming for a contiguous circle enclosing all PVs. RF will be delivered in a power-controlled mode (without ramping) using 35-40 Watt. The irrigation rate will be set at 30 ml/min. RF will be delivered until an ablation index (AI) of ≥400 is reached at the posterior wall and ≥550 at the anterior wall. In case of dislocation, a new RF application reaching the AI target will be applied. Maximal intertag distance between two neighboring lesions is 6 mm. In case of intra-esophageal temperature (T°) rise >38.5°C during posterior LA wall ablation, RF delivery will stopped at an AI of 300. In the absence of first pass isolation, touch-up ablation was applied until PVI. In case of reconnection during the waiting time or during the adenosine test, the site of reconnection will be located and treated with touch-up ablation until adenosine proof PVI is reached.
15781439|NCT04602169|Procedure|PVI + SVC|Patients in this group receive PVI according to the CLOSE protocol. In addition, they will receive an SVC isolation. The circular mapping catheter will be introduced in the superior vena cava to determine baseline electrical activity and to confirm definite entrance and exit block after ablation. Ablation will be performed proximally to the SVC/right atrial junction with the contact force-catheter using circular point-by-point radiofrequency delivery with a power setting of 35W, targeting an AI ≥400. High output (25 mA) pacing will be applied before each RF application to check for phrenic nerve stimulation. In areas of phrenic nerve capture ablation will be avoided even in case of incomplete isolation.
15781440|NCT04602156|Procedure|Trocar percutaneous cholecystostomy|Percutaneous cholecystostomy using the one-step Trocar technique under US guidance. An 8Fr Trocar catheter will be inserted percutaneously within the gallbladder under real-time US guidance. The procedure will be performed using an aseptic technique, local anesthesia and intravenous opioid analgesia.
15781441|NCT04602156|Procedure|Seldinger percutaneous cholecystostomy|Percutaneous cholecystostomy using the Seldinger technique under US guidance. Following percutaneous puncture of the gallbladder with an 18G needle under real-time US guidance, an 8Fr catheter will be inserted percutaneously over the wire within the gallbladder under real-time US guidance. The procedure will be performed using an aseptic technique, local anesthesia and intravenous opioid analgesia.
15781442|NCT04602143|Drug|Testosterone gel|Apply 12.5mg testosterone gel to the abdomen and rub on with one finger, once a day, in the morning, then allow sites to dry and cover with clothing. Continue the treatment for 4 or 6 weeks until next IVF treatment.
15781443|NCT04602130|Other|Control|"The control group (n: 48) received no intervention except for the routine clinical practices. The newborns' physiological measurements before, immediately after and 30 minutes after the interventions were taken and recorded on the Newborn Follow-up Form."
15781444|NCT04602130|Other|Massage|"The researcher applied massage (n: 48) to the newborns. The newborns' physiological measurements before, immediately after and 30 minutes after the interventions were taken and recorded on the Newborn Follow-up Form."
15781445|NCT04602130|Other|Sponge Bathing|"The researcher applied sponge bathing (n: 48) to the newborns. The newborns' physiological measurements before, immediately after and 30 minutes after the interventions were taken and recorded on the Newborn Follow-up Form."
15781446|NCT04602130|Other|Tub Bathing|"The researcher applied tub bathing (n: 48) to the newborns. The newborns' physiological measurements before, immediately after and 30 minutes after the interventions were taken and recorded on the Newborn Follow-up Form."
15781454|NCT04602091|Other|no intervention|no intervention
15781455|NCT04602078|Drug|Atezolizumab 1200 mg/m2|Fixed dose of 1200 mg/m2 by intravenous (IV) infusion on D1 of each cycle up to disease progression, unacceptable toxicity or absence of clinical benefit.
15781456|NCT04602078|Drug|Gemcitabine 1000 mg/m2|Gemcitabine 1000 mg/m2 IV on D1 and 1000 mg/m2 IV on D8 of each 21-day cycle for up to 6 cycles.
15781457|NCT04602078|Drug|Cisplatin 70 mg/m2|Cisplatin 70 mg/m2 by IV on split-dose schedule of 35 mg/m2 on day 1 (D1) and 35 mg/m2 on day 8 (D8) for up to 6 cycles.
15781459|NCT04602052|Procedure|Dilation and evacuation|Abortion is termination of pregannacy by evaccuating the uterus using either medical or surgical technique
15781460|NCT04602039|Dietary Supplement|Bovine Colostrum|Bovine colostrum (Neovite)
15781461|NCT04602026|Other|Best Practice|Receive standard of care
15781462|NCT04602026|Behavioral|Exercise Intervention|Complete home exercise intervention
15781463|NCT04602026|Procedure|Physical Therapy|Undergo physical therapy
15781464|NCT04602026|Other|Questionnaire Administration|Ancillary studies
15781465|NCT04602013|Drug|Sintilimab|Body weight <60kg: 3mg/kg IV Q3W; Body weight ≥60kg: 200mg IV Q3W. Every three weeks is a cycle
15781466|NCT04602013|Drug|Chemotherapy|"Chemotherapy drugs include cisplatin and albumin-bound paclitaxel for injection Paclitaxel for injection (albumin-bound type) dose: 3 dose groups (di=260 mg/m2, di-1=220 mg/m2, di-2=180 mg/m2).
~Dosing on the first day, one cycle every three weeks, a total of 2 cycles. Cisplatin (25mg/m2 IV D1-3 Q3W)"
15781467|NCT04602013|Radiation|Radiation Therapy|The total dose is 60-66 Gy, divided into 30-33 times (2.0 Gy/f, 5 f per week).
15781468|NCT04602000|Biological|CT-P59/Placebo|administered
15781469|NCT04601987|Behavioral|Breastfeeding|Counseling about the maternal health benefits of lactation.
15781470|NCT04601987|Behavioral|Smokefree Homes|Counseling about the importance of smoke-free homes.
15781471|NCT04601974|Genetic|lentiviral gene therapy|lentiviral gene therapy to treat drug resistant epilepsy
15781472|NCT04601961|Drug|Propofol|"Monitoring and other anaesthetic procedures including the management of hypertension and hypotension will be the same as SEVO group. Induction and maintenance of general anaesthesia will be conducted using total intravenous infusion of propofol. Sevoflurane will not be used, and oxygen and air would be given to provide a FiO2 of 30-50%.
~Target controlled infusion (TCI) with a modified Marsh effect site model (Fresenius Kabi) will be used for induction and maintenance of general anaesthesia and titrated to effect. The usual effect site concentration is 1.5-3 mcg.ml-1 and BIS monitoring will also be used to produce a value of between 40-60. As with patients in the SEVO group, remifentanil will be infused at a rate of between 0.1-0.3 mcg.kg.min-1."
15781473|NCT04601961|Drug|Sevoflurane|Propofol 1.5-3mg/kg, remifentanil 1mcg/kg, and rocuronium 0.6-1mg/kg or atracurium 0.5mg/kg will be used intravenously for induction of general anaesthesia. Intubation would be performed after induction of general anaesthesia. General anaesthesia monitoring will be used. Sevoflurane, air and oxygen will be used for maintenance of general anaesthesia. FiO2 will be kept between 35-50%. BIS monitoring will be applied and level of anaesthetia will be titrated to maintain a BIS value of between 40-60. Intravenous remifentanil infusion between 0.1-0.2 mcg/kg/min will be given and this will be titrated to provide optimal haemodynamic parameters.
15781474|NCT04601948|Behavioral|mHealth Activity Intervention|Eligible participants will receive a Fitbit activity monitor and access to our mHealth physical activity intervention for 6 weeks. The intervention will include regular motivational messages to encourage activity, a social media thread to provide social support, and a series of fun virtual walking races.
15781475|NCT04601935|Biological|LCAR-BCX cells product|In this study, LCAR-BCX CAR+ cells will be evaluated at 5 dose levels including 0.25 × 10^6 cells/kg, 0.5 × 10^6 cells/kg, 1.0 × 10^6 cells/kg, 2.0 × 10^6 cells/kg, and 4.0 × 10^6 cells/kg, with 0.25 × 10^6 cells/kg as the starting dose, to determine RP2D for LCAR-BCX cell therapy
15781476|NCT04601922|Other|Semi-structured interview|The interview will have the audio recorded, and will explore the ideas of each participant around long term cardiovascular care pathways
15781477|NCT04601909|Drug|FX-322|active comparator
15781478|NCT04601909|Other|placebo|placebo
15781479|NCT04601896|Other|SF36 questionnaire via telephone interview|SF36 questionnaire via telephone interview
15781480|NCT04601883|Drug|Colchicine 0.5 MG|"The intervention tablets are commercially available Colchicine Tiofarma"
15781481|NCT04601883|Drug|Placebo|Encapsulated placebo tablets. Placebo is identical to the active intervention.
15781482|NCT04601870|Other|No Financial Incentive|No monetary incentive to participate in quit planning and quit counseling with a tobacco cessation specialist.
15781483|NCT04601870|Other|Financial Incentive (100 dollars)|Financial incentive (100 dollars) to participate in quit planning and quit counseling with a tobacco cessation specialist.
15781484|NCT04601870|Other|Financial Incentive (50 dollars)|Financial incentive (50 dollars) to participate in quit planning and quit counseling with a tobacco cessation specialist.
15781485|NCT04601857|Drug|Futibatinib and Pembrolizumab|Patients will receive Futibatinib at an oral dose of 20 mg daily and Pembrolizumab at an intravenous dose of 200 mg every 3 weeks
15781486|NCT04601844|Drug|Pozelimab|Single dose administered subcutaneously
15781487|NCT04601844|Drug|Cemdisiran|Single dose administered SC
15781488|NCT04601831|Radiation|Focal radiation therapy (RT)|"Radiation therapy- 2 dose levels:
~Definitive 40-50 Gy EQD2 (i.e. 30 Gy in 5 fractions), or if de-escalation needed,
~Palliative 20-32.5 Gy EQD2 (i.e. 20 Gy in 5 fractions)
~Hypofractionated regimen (i.e. 5 fractions in 1-2 weeks) recommended, but other fractionation schemes (10-20 fractions in 2-4 weeks) allowed."
15781489|NCT04601818|Procedure|Experimental: Preserving of Donor Lungs|lung transplants that have a proposed after hours start time will be delayed until 6am and the donor lungs will be preserved for no more than 12 hours at 10 degrees celsius cold static
15781490|NCT04601805|Device|Observation|We will record the vascular changes that follow the inflammatory bowel diseases
15781491|NCT04601792|Drug|Individualized Decoction|Applied in the Tested Drug Observation Period. It is the highly individualized treatment of TCM, the modification of Bronchiectasis Stabilization Decoction (Rhizoma Fagopyri Cymosi 30g, Radix Lithospermi 15g, Radix Ophiopogonis 15g, Poria cocos 15g, Radix Astragali 20g, Rhizoma Bletillae 10g, Platycodon grandiflorum 10g, Semen Coicis 30g) based on syndrome differentiation. For example, for patients with qi and yin deficiency syndrome, the investigators added Adenophora Root, Radix Glehniae and Radix Rehmanniae Recens etc. For patients with phlegm-heat syndrome, the investigators added Radix Scutellariae and Viola Yedoensis etc. Besides, the herbs in a prescription could be changed according to different symptoms of individual patients.
15781492|NCT04601792|Drug|placebo|Applied in the placebo Observation Period. Placebo is made by dextrin, bitter agent, edible pigment etc. and added 5% test drug. The test drug and control drug have no differences in dosage form, appearance, color, specification, label, and so forth.
15781601|NCT04600778|Other|placebo|placebo
15781602|NCT04600778|Drug|Cavosonstat 5 mg|Cavosonstat (low dose)
15781493|NCT04601792|Drug|Tested drug minus heat-clearing herbs|It is the decoction of the Syndrome Differentiation Decoction (tested drug) minus heat-clearing herbs. For example, heat-clearing herbs such as Scutellaria Baicalensis, Rhizoma Coptidisor Herba Violae will be removed from the Syndrome Differentiation Decoction.
15781494|NCT04601779|Behavioral|VIPP-PUF|The VIPP-PUF Intervention is developed as an add-on to the existing PUF-programme to address infants with major cognitive and regulatory vulnerabilities identified at age 9-10 months and adapted to the settings of community health nurses. The intervention (VIPP-PUF) will be created from an evidence-based method, the Video-based Intervention to Promote Positive Parenting (VIPP), to comprise six therapeutic sessions delivered by the community health nurse during home visits over a three months period. The VIPP -PUFbuilds on teaching the health nurses to promote parents' sensitivity to meet infants' cognitive and regulatory vulnerabilities, while taking in account the particular needs of families of psycho-social disadvantage.
15781495|NCT04601766|Drug|APL-1202+APL-1501 ER Tablets 3+APL-1501 ER Tablets 2|Phase1: Period 1 drug administration( APL-1202 50 mg, 3 tablets, orally );Washout( 7± 1 day) ; Period 2 drug administration(1501 ER Tablets 3 382 mg ASN-1324, 1 tablet); Phase2:Washout(The initiation of second phase will depend on the results of first phase within 30 days and not less than 7 days after the first phase ); Period 3 (APL-1501 ER Tablets 2,382 mg ASN-1324, 1 tablet)
15781496|NCT04601766|Drug|APL-1501 ER Tablets 3+APL-1202+APL-1501 ER Tablets 2|Phase1: Period 1 drug administration( 1501 ER Tablets 3 382 mg ASN-1324, 1 tablet );Washout( 7± 1 day) ; Period 2 drug administration(APL-1202 50 mg, 3 tablets, orally); Phase2:Washout(The initiation of second phase will depend on the results of first phase within 30 days and not less than 7 days after the first phase ); Period 3 (APL-1501 ER Tablets 2,382 mg ASN-1324, 1 tablet)
15781497|NCT04601753|Drug|Oral Semaglutide|Patients will be treated with commercially available oral semaglutide according to local label and to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study.
15781498|NCT04601740|Drug|Oral Semaglutide|Patients will be treated with commercially available oral semaglutide according to local label and to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study.
15781499|NCT04601727|Diagnostic Test|16srRNA pyrosequencing analysis of microbiota of saliva and faeces|No intervention in this study
15781500|NCT04601701|Drug|Bevacizumab Ophthalmic and Intravitreal Dexamethasone.|Pro re nata patients with CRVO will initially receive Bevacizumab and intravitreal Dexamethasone. And then depending on their clinical status of CRVO, Bevacizumab will be injected.
15781501|NCT04601701|Drug|Bevacizumab Ophthalmic.|Pro re nata patients with CRVO will receive Bevacizumab. And then depending on their clinical status of CRVO, Bevacizumab will be injected.
15781502|NCT04601688|Drug|Bevacizumab Ophthalmic and Intravitreal Dexamethasone|Pro re nata patients with BRVO will initially receive Bevacizumab and intravitreal Dexamethasone. And then depending on their clinical status of BRVO, Bevacizumab will be injected.
15781503|NCT04601688|Drug|Bevacizumab Ophthalmic|Pro re nata patients with BRVO will receive Bevacizumab. And then depending on their clinical status of BRVO, Bevacizumab will be injected.
15781504|NCT04601675|Drug|Ranibizumab Ophthalmic and Intravitreal Dexamethasone|Pro re nata patients with macula edema due to diabetes will receive Ranibizumab. Group A will continue to receive Ranibizumab depending on their clinical status of macular edema
15781505|NCT04601675|Drug|Ranibizumab Ophthalmic only|Group B will initially receive intravitreal Dexamethasone and Ranibizumab and then depending on their clinical status of macular edema, Ranibizumab will be injected.
15781506|NCT04601662|Procedure|Corticision|A special instrument will be used to cut the cortex of the alveolar bone at different locations between the lower anterior teeth
15781507|NCT04601662|Other|Traditional Non-accelerated Treatment|The normal sequence of treatment steps will be followed in this group without using any kind of acceleration methods
15781508|NCT04601649|Behavioral|PrEP Talk|The study is designed to provide education, support, and referrals for PrEP.
15781509|NCT04601636|Device|Active Prewarming|Active prewarming with Flex Warming Gown (Bair Paws, 3M) for at least 30 minutes before induction of anesthesia, with active warming intraoperatively with Bair Hugger (3M)
15781510|NCT04601636|Other|Standard Care|Standard care with a passive prewarming (warm cotton blankets) before induction of anesthesia, with active warming intraoperatively with (Bair Hugger, 3M)
15781511|NCT04601623|Other|Sonoelastography|This diagnostic test would be executed by a physician who has experiences of using Siemens Acuson S2000 ultrasound system for more than three year. The examination includes two of four rotator cuff muscles, listed as follows, supraspinatus muscle and infraspinatus muscle. Linear transducer (4-9 MHz) would be used for the whole test. The probe would be positioned along the longitudinal axis of the muscle belly. Compressive sonoelastography technique is used for semiquantitative analysis. In order to maintain the quality of images, quality factor needs to be over or equal to 60. The quantitative analysis was performed by shear wave sonoelastography and the region of interest (ROI) would be divided into four quadrants. The physicians will measure the shear wave velocity at the center point of each quadrant.
15781512|NCT04601610|Drug|KN046 （PD-L1/CTLA4 BsAb）|KN046 5mg/kg Q3W
15781513|NCT04601610|Drug|Ningetinib Tosylate（multi-target TKI）|ningtinib QD, dose will be decided by investigator
15781520|NCT04601571|Device|CORTRAK Stylet|The stylet is a component of the CORTRAK feeding tube system used to confirm the correct placement of the feeding tube
15781521|NCT04601558|Behavioral|The letters with the Cochrane abstracts in the form of blog-shots|"The active intervention were letters with the remainder on participant's own cardiovascular risk factors, a participant's own count of 10-year risk of cardiovascular disease, and Cochrane abstract in the form of blog-shots and personal advice in reducing cardiovascular disease risk.
~There were three Cochrane blog-shots. The first was about calcium in prevention of high blood pressure, the second was about the effect of reducing saturated fat acids in eating habits and the third consisted evidence of green and black tea for the prevention of cardiovascular diseases.
~The letters were sent three times, every two months after the participants received first letter about cardiovascular disease risk."
15781522|NCT04601558|Behavioral|The letters with remainder on cardiovascular risk factors|"The passive intervention were letters with the remainder on participant's own cardiovascular risk factors and participant's own count of 10-year risk of cardiovascular disease.
~The letters were sent three times, every two months after the participants received first letter about cardiovascular disease risk."
15781523|NCT04601545|Behavioral|Pulmonary rehabilitation|"Three weeks of pulmonary rehabilitation conducted in an outpatient care facility:
~5- time a week for 30 minutes a specific respiratory exercises- relaxation exercises for breathing muscles, exercises to increase breathing, prolonged exhalation exercise, chest percussion
~5- time a week for 20-30 min training on a cycle ergometer - until the Heart Rate reaches 60% of the HRmax
~5- time a week for 30 minutes a fitness and respiratory exercises - coordination and balance exercises, stretching exercises
~relaxation by Schultz Autogenic Training. The technique involves the daily practice of sessions that last around 15 minutes. During each session, the practitioner repeats a set of visualisations that induce a state of relaxation."
15781524|NCT04601545|Device|Virtual therapeutic support|"8 sessions of VR therapy (each of them 20 minutes long). As a virtual reality source, VR Tier One device (Stolgraf®) were used. Thanks to using head mounted display and the phenomenon of total immersion VR therapy provides an intense visual, auditory and kinesthetic stimulation. It can have a calming and mood-improving effect or help the patients recognize their psychological resources and motivate to the rehabilitation process. In the virtual therapeutic garden there are a rich set of symbols and metaphors based on Ericksonian Psychotherapy approach. The most important is the Garden of Revival which symbolizes the patient's health. It used to be full of life and energy, now it is neglected, requires work to be revived. In the therapeutic process day by day, the therapist tells the patient a symbolic story about his/her situation.
~By performing tasks in the virtual garden, the patient becomes an active participant of the therapeutic process and sees the effects his/her work."
15781525|NCT04601532|Device|Catasyn™ Advanced Technology Hydrogel and SynePure™ Wound Cleanser|Catasyn™ Advanced Technology Hydrogel is a wound hydrogel that provides a moist wound environment. A moist wound environment is supportive to wound healing. SynePure™ Wound Cleanser is a non-cytotoxic wound cleanser for the removal of foreign material from epidermal and dermal wounds, burns, cuts, abrasions and minor irritations of the skin.
15781526|NCT04601532|Drug|Silver Sulfadiazine|Silver sulfadiazine, a sulfa drug, is used to prevent and treat infections in burn wounds.
15781527|NCT04601519|Other|Cross-sectional observational study|Online questionnaire on the impact of type 1 diabetes on sleep quality
15781528|NCT04601506|Behavioral|Choice Architecture Nudge|"Primary Care Providers (PCPs) will be sent alerts in the Electronic Health Record system when they initiate an opioid order for a patient who has not had an opioid prescription within the past six months. The alert provides guidance language about opioid prescribing and prompts the PCP to open the SmartSet to order non-opioid treatment alternatives. When the SmartSet is opened, PCPs can choose to click on a variety of treatment order options, including both non-opioid pharmacological options and non-pharmacological options.
~PCPs will also be sent alerts when they initiate an opioid order for a patient will a current opioid prescription. The alerts prompt PCPs to consider tapering the patient's opioid. The alert also displays the MME of the patient's current opioid prescription and automatically calculates what a 10% reduction in MME relative to the current prescription would be. The alert contains options to either cancel the refill order, or to continue with the order."
15781529|NCT04601506|Behavioral|PMP Integration & Nudge|During the Prescription Drug Monitoring Program (PMP) integration & nudge intervention, Primary Care Providers (PCPs) will have integrated access to the PMP embedded within the EHR. All clinicians can already access the PMP to look up a patient's prior opioid prescriptions and prescription fills. However, this process involves signing in to the separate PMP website and can be complicated and time-consuming within typical clinical workflow. The integrated PMP tool makes it much easier and faster for a PCP to access the PMP information for a given patient.
15781530|NCT04601493|Behavioral|Choice Architecture Nudge|"During the choice architecture nudge intervention, Primary Care Providers (PCPs) will be sent alerts in the Electronic Health Record (EHR) system when they initiate an opioid order for a patient who has not had an opioid prescription within the past six months. The alert provides guidance language about opioid prescribing and prompts the PCP to open the SmartSet to order non-opioid treatment alternatives. PCPs can choose to ignore this, but opening the SmartSet is the default option. When the SmartSet is opened, PCPs can choose to click on a variety of treatment order options, including both non-opioid pharmacological options and non-pharmacological options (e.g., referral to physical therapy or pain clinic)."
15781531|NCT04601493|Behavioral|PMP Integration & Nudge|During the Prescription Drug Monitoring Program (PMP) integration & nudge intervention, Primary Care Providers (PCPs) will have integrated access to the PMP embedded within the EHR. All clinicians can already access the PMP to look up a patient's prior opioid prescriptions and prescription fills. However, this process involves signing in to the separate PMP website and can be complicated and time-consuming within typical clinical workflow. The integrated PMP tool makes it much easier and faster for a PCP to access the PMP information for a given patient.
15781532|NCT04601480|Behavioral|Choice Architecture Nudge|During the choice architecture nudge intervention, Primary Care Providers (PCPs) will be sent alerts in the Electronic Health Record (EHR) system when they initiate an opioid order for a patient will a current opioid prescription. The alerts prompt PCPs to consider tapering the patient's opioid. The alert also displays the MME of the patient's current opioid prescription and automatically calculates what a 10% reduction in MME relative to the current prescription would be. The alert contains options to either cancel the refill order, or to continue with the order.
15781603|NCT04600778|Drug|Cavosonstat 10 mg|Cavosonstat (medium dose)
15781533|NCT04601480|Behavioral|PMP Integration & Nudge|During the Prescription Drug Monitoring Program (PMP) integration & nudge intervention, Primary Care Providers (PCPs) will have integrated access to the PMP embedded within the EHR. All clinicians can already access the PMP to look up a patient's prior opioid prescriptions and prescription fills. However, this process involves signing in to the separate PMP website and can be complicated and time-consuming within typical clinical workflow. The integrated PMP tool makes it much easier and faster for a PCP to access the PMP information for a given patient.
15781534|NCT04601467|Drug|AZD5718|Oral dose of AZD5718 (tablet) once daily for 12 months
15781535|NCT04601467|Drug|Placebo|Oral dose of matching placebo (tablet) once daily for 12 months
15781536|NCT04601454|Device|Spinal Cord Stimulation System|Implanted neurostimulation system (neurostimulator and leads) with on-label stimulation parameters.
15781537|NCT04601441|Drug|Apalutamide|Apalutamide 240 mg administered orally once a day as four 60 mg tablets
15781538|NCT04601428|Biological|IA therapy of HCC with CSR02-Fab-TF|Intra-Arterial Infusion of CSR02-Fab-TF
15781539|NCT04601415|Diagnostic Test|ECG from handheld device|Acquisition of a single-lead ECG at time of presentation to GP and at echo appointment
15781540|NCT04601402|Drug|GEN-001|The capsules taken by mouth once a daily. Each capsule will contain ≥ 1x10^11 colony-forming units (CFU)
15781541|NCT04601402|Drug|Avelumab|800 mg given by intravenous (IV) infusion once every 2 weeks
15781542|NCT04601389|Biological|"Omalizumab (JSC GENERIUM, the Russian Federation)"|150 mg of omalizumab was subcutaneously injected once in the deltoid muscle area
15781543|NCT04601389|Biological|Xolair® (Novartis Pharma AG, Switzerland)|150 mg of omalizumab was subcutaneously injected once in the deltoid muscle area
15781544|NCT04601376|Behavioral|Mobile Monitoring Tool|a text-messaged based outcomes collection system
15781545|NCT04601363|Device|Patient Specific Rod|Posterior spinal fusion rod
15781546|NCT04601350|Drug|Remimazolam with a dose of 0.05mg/kg for induction of general anesthesia|Remimazolam with a dose of 0.05mg/kg for induction of general anesthesia
15781547|NCT04601350|Drug|Remimazolam with a dose of 0.1mg/kg for induction of general anesthesia|Remimazolam with a dose of 0.1mg/kg for induction of general anesthesia
15781548|NCT04601350|Drug|Remimazolam with a dose of 0.2mg/kg for induction of general anesthesia|Remimazolam with a dose of 0.2mg/kg for induction of general anesthesia
15781549|NCT04601350|Drug|Remimazolam with a dose of 0.3mg/kg for induction of general anesthesia|Remimazolam with a dose of 0.3mg/kg for induction of general anesthesia
15781550|NCT04601337|Procedure|Infrared Neural Stimulation|We will stimulate nerves identified for transfer or grafting over a range of simulation parameters (pulse width, spot size, energy per unit area, etc) to determine the stimulation threshold. Only portions of the nerve that are no longer functionally required will be stimulated optically. Successful INS events will be determined by visual muscle contractions. Stimulation thresholds will be determined by fitting the data to a cumulative distribution function. Stimulation sites on the nerve will be harvested and histologically examined for evidence of INS-induced damage.
15781551|NCT04601324|Drug|Fluticasone Propionate|Participants will be required to use fluticasone propionate nasal spray twice daily.
15781552|NCT04601324|Drug|Azelastine hydrochloride and fluticasone propionate|Participants will be required to administer twice daily MP-AzeFlu nasal spray (formulation of 137 mg of azelastine hydrochloride/50 mg of fluticasone propionate) separated by 12 hours.
15781553|NCT04601324|Drug|Rupatadine|Rupatadine once daily for a total of 2 weeks.
15781556|NCT04601285|Drug|JS108 (recombinant humanized anti-Trop2 mAb-Tub196 conjugate for injection)|"Dose escalation period: JS108 is administered intravenously every three weeks (Q3W) at the dose corresponding to the enrolled dose cohort.
~Dose expansion period: JS108 is administered intravenously Q3W at the corresponding dose.
~Clinical expansion period: JS108 is administered intravenously Q3W at the recommended dose."
15781557|NCT04601272|Behavioral|Decision aid|Healthwise patient decision aids for breast, prostate, colon and lung cancer screening provide information on the pros and cons of cancer screening and guidance in process of selecting a choice.
15781558|NCT04601259|Combination Product|Orkla Corn Plaster with salicylic acid|Each participating subject will receive Orkla Corn Plasters for usage up to 28 days, or until corn resolution whichever comes first. Subjects will be instructed to change plasters daily.
15781559|NCT04601259|Device|Orkla Corn Protector|Each participating subject will receive Orkla Corn Protector for usage up to 28 days, or until corn resolution whichever comes first. Subjects will be instructed to change plasters daily.
15781560|NCT04601233|Drug|XYOSTED 75 milligram (mg) in 0.5 ML Auto-Injector|Self injection testosterone treatment
15781561|NCT04601207|Drug|Cannabis Preparation|Dosed as a single oral dose
15781562|NCT04601207|Drug|Cannabis Preparation|Dosed as a single oral dose
15781563|NCT04601194|Behavioral|Coaching and Virtual Provider Program Practice|4 weekly goal setting/coaching sessions, coupled with Virtual Provider program training and practice
15781564|NCT04601181|Biological|ThisCART22 cells injection|"Assigned Interventions Biological/Vaccine: ThisCART22 cells 0.2-60 x 10^6 CAR-T cells per kg body weight.
~Intervention study"
15781604|NCT04600778|Drug|Cavosonstat 25 mg|Cavosonstat (high dose)
15781605|NCT04600765|Diagnostic Test|hsCRP serum measurement of inflammation|hsCRP inflammation change as result of non-contaminated diet
15781565|NCT04601168|Device|kneeSOFT100|During the first two weeks of follow-up, the subject shall not use the device during the sports sessions. The subject shall use the device during the sports sessions for the next 4 weeks (6 weeks of follow-up)
15781566|NCT04601155|Device|AlloSure|AlloSure is an analytically validated targeted next-generation sequencing (NGS) assay that uses single-nucleotide polymorphisms (SNPs) to measure the fraction of dd-cfDNA in transplant patients without the need for genotyping either the donor or the recipient.8
15781567|NCT04601142|Drug|Methylprednisolone|methylprednisolone pulse therapy: 500-1000mg/d，３-５ｄ
15781568|NCT04601129|Procedure|enhanced recovery after surgery program|practice of an enhanced recovery after surgery program, according to the international reviews of literature and national recommendation
15781569|NCT04601116|Drug|Atorvastatin 80 Mg Oral Tablet|Atorvastatin 80 mg per day for 2 years
15781570|NCT04601116|Drug|Placebo oral tablet|Placebo 1 tablet per day for 2 years
15781571|NCT04601090|Other|ICU treatment|This is an observational study, so all patients will undergo a variation of ICU treatment, and we will record that information (e.g., time on ventilator, time in ICU, SAPS score at admission)
15781572|NCT04601077|Drug|Nitric Oxide lozenges, 30 mg|Nitric Oxide lozenge, 30 mg twice a day for 30 days
15781573|NCT04601077|Drug|Placebo|Placebo for Nitric Oxide lozenge, 30 mg twice a day for 30 days
15781574|NCT04601064|Behavioral|Collaborative Care Model|Collaborative care (CC) is an evidence-based model of integrated mental health and substance use disorder care endorsed by the American Psychiatric Association for the integration of mental health and substance use disorder care into primary care settings. CC includes the following components: 1) A collaborative care team of multidisciplinary health care providers consisting of the primary physician, a care manager and a consulting psychiatrist, providing care in a coordinated fashion; 2) A population focus with the team working together to provide care and continuously measure and track health outcomes of a defined population of patients; 3) A measurement-guided approach with systematic use of disease specific patient reported outcome measures, such as symptom rating scales like the PHQ-9 to drive clinical decision making; and 4) Evidence-based practices with the team adapting scientifically proven treatments within an individual clinical context to achieve improved health outcomes.
15781576|NCT04601038|Drug|CORT108297|180mg of a selective glucocorticoid receptor antagonist, taken as 3 tablets daily for 2 weeks
15781577|NCT04601038|Drug|Placebo|Placebo taken as 3 tablets daily for 2 weeks
15781578|NCT04601025|Dietary Supplement|Yoghurt|200 ml plain full-fat yoghurt
15781579|NCT04601025|Dietary Supplement|Chickpea+Yoghurt|80 ml plain full-fat yoghurt + 70 gr cooked chickpea
15781580|NCT04601025|Dietary Supplement|Oat+Yoghurt|80 ml plain full-fat yoghurt + 100 gr cooked oat
15781581|NCT04601012|Diagnostic Test|Optical coherence tomography angiography|Each subject underwent optical coherence tomography angiography to evaluate the retinal vessel density.
15781582|NCT04600999|Drug|Favipiravir|Name: AVIGAN Generic name: Favipiravir Content: T-705a tablets [200]
15781583|NCT04600986|Other|Repeated dose of GnRH agonist|0.2 mg triptorelin plus a repeat dose of 0.1 mg 12 hours following the first dose.
15781584|NCT04600973|Behavioral|Technical assistance or team-based coaching|Main comparison in delivering peri-operative preventive strategies against transmission and infection is one on one technical assistance or team-based coaching.
15781585|NCT04600960|Drug|Eltrombopag|The subjects will initiate treatment with 75 mg eltrombopag. Platelet counts is obtained weekly and dose adjustment should be done according to platelet counts, and maximum dose should not exceed 75 mg daily. Subjects whose platelet count ≤100×109/L，the eltrombopag dose will maintain. If platelet count >100×109/L for 2 weeks, the subjects need to reduce the dose of eltrombopag to the next lower dose or lower frequency. If subjects whose platelet count exceeds 100×109/L for 4 weeks，already have reduced the dose of eltrombopag to 25mg once every other day during the treatment period, eltrombopag can be stopped for observation, until platelet counts fall below 100×109/L.
15781586|NCT04600947|Drug|LP002|10 mg/kg administered as IV infusion on Day 1 of each 14-day cycle.
15781587|NCT04600934|Device|Shockwave|Shockwave Medical, Inc. Peripheral Lithoplasty® System
15781588|NCT04600934|Device|Plain old balloon angioplasty|POBA
15781589|NCT04600921|Drug|Ertugliflozin 5 mg|The subject will receive Ertugliflozin 5mg orally once daily for 52 weeks.
15781590|NCT04600921|Drug|Placebo 5mg|The subject will receive Placebo 5mg orally daily for 52 weeks.
15781591|NCT04600908|Other|Characteristics of accidents|informations about commuting accidents were recorded either during an occupational medicine consultation or by the medical service after reception of the medical certificate and the administrative declaration
15781592|NCT04600895|Drug|Favipiravir|Favipiravir
15781593|NCT04600895|Drug|Placebo|Placebo
15781594|NCT04600869|Other|Naturalistic Decision-Making Model-based Oncofertility Care Education|We designed the education program according to Klein's NDM model, which explored the reasoning mechanism behind decision-making (Klein, 1993). It depends on the on-the-job training date in each unit. The education program consisted of the following: (1) Information accumulation: explanations of common cancer therapies related to subsequent infertility, psychological and mental change in cancer survivors with infertility, the necessity and method of early determination of fertility intention, and type of fertility preservation. (2) Sense-making: situational case sharing, emphasis on the guidance interaction between experienced and novice nurses to understand the patient's situation. (3) Decision-making: how to provide support, how to correspond, and attitudes toward people with strong fertility intention.
15781595|NCT04600843|Other|Physical therapy with Patient education|patient manual was translated and validated in Urdu which was provided to patients so that they can follow it at home
15781596|NCT04600843|Other|Physical Therapy without patient Education|Group B was only treated with proper physical therapy treatment protocol according to patient presenting condition
15781597|NCT04600830|Procedure|Dry needling|Intervention with deep dry needling on latent myofascial trigger points (MTrPs) in gastrocnemius muscle.
15781598|NCT04600817|Drug|TJ107|QW8
15781599|NCT04600817|Drug|TJ107 placebo|QW8
15781606|NCT04600752|Drug|Augmentin (ES)-600|Augmentin ES will be administered as reconstituted oral suspension containing Amoxicillin and Potassium Clavulanate 600 mg/42.9 mg per 5 milliliters.
15781607|NCT04600739|Procedure|TAVI|Replacement of the aortic valve using a biological prosthesis that is inserted via a catheter.
15781608|NCT04600726|Other|no intervention|no interventioni
15781609|NCT04600713|Other|PT-X and IMT|The intervention consists of PT-X, including central circulatory exercise and muscle exercises, 2 times/week, 60 min/session for 12 weeks, and homebased exercises 2 times/week logged in an exercise diary. For IMT the Threshold Inspiratory Muscle Trainer (Threshold IMT) (Respironics Inc., Murrysville, PA, USA) will be used at 30 % of maximal expiratory pressure in 15 minutes 2 times a day during 12 weeks.
15781610|NCT04600700|Device|Clinical Decision support system (CDSS) for inotrope weaning|A Clinical Decision Support System informed by 6-hour rolling average IDO2, will be utilized during the intervention phase of the study. The CDSS tool will be introduced in a stepped-wedge pattern. Randomization will occur by center, with time of introduction being staggered, with each center ultimately receiving the CDSS intervention. Teams in the CICU make rounds twice per day. During each of the rounds (AM and PM), the team will refer to the CDSS and the 6-hour average IDO2 (as reported on the T3 platform at the bedside computer). The clinical team will consider the CDSS in decision making around inotrope weans. If the decision is made to not utilize IDO2, the bedside clinician will complete a brief survey with rationale.
15781611|NCT04600687|Other|Placebo tablets|Participants will take placebo tablets identical to the commercial versions of the two combination antiretroviral single tablet regimens of bictegravir/emtricitabine/tenofovir alanfenamide and dolutegravir/abacavir/lamivudine.
15781612|NCT04600674|Procedure|Delayed cord clamping|DCC performed at 60 sec after birth
15781613|NCT04600674|Procedure|Early cord clamping|ECC performed at 15 sec after birth
15781614|NCT04600661|Other|Traditional exercise therapy|Neuromuscular training
15781615|NCT04600648|Diagnostic Test|Serum insulin level|Measure levels before and after weight loss related to bariatric surgery
15781616|NCT04600648|Diagnostic Test|Serum Leptin test|Measure levels before and after weight loss related to lifestyle change weight loss
15781617|NCT04600635|Procedure|Bariatric surgery|Some patients in the cohort are followed by a multidisciplinary team in preparation for bariatric surgery. Others have already undergone bariatric surgery and are being followed up postoperatively.
15781618|NCT04600622|Behavioral|Rural Diabetes One-Day Education and Care program (R-D1D)|One time, 5.5-hour multi-disciplinary diabetes self-management education and support intervention delivered via telehealth.
15781619|NCT04600622|Behavioral|Diabetes Education Materials|Diabetes Education Materials
15781620|NCT04600596|Behavioral|Recording of food intake.|The food intake is recorded with a photographic food recognition mobile application. The total energy expenditure is recorded with the DLW method.
15781621|NCT04600583|Device|Triathlon® Total Knee System (Stryker Orthopaedics, Mahwah, NJ USA)|All patients, regardless of the alignment arm they are randomized to will undergo a primary total knee arthroplasty with the Triathlon® Total Knee System using Mako Robotic-Arm Assisted Technology. The surgical intervention will be administered by a physician wherein the expected duration of surgery is approximately 1.5 hours.
15781622|NCT04600570|Other|ultrasound|ultrasound measurement for optic nerve outer diameter
15781623|NCT04600557|Behavioral|Describing a shameful experience using a self-compassionate prompt|Participants will be instructed to describe a shameful experience to two confederates using a self-compassionate prompt
15781624|NCT04600557|Behavioral|Receiving compassionate responses from confederates|Following the participant's description of a shameful experience, two confederates will respond with compassionate responses
15781625|NCT04600557|Behavioral|Describing a shameful experience using a neutral prompt|Participants will be instructed to describe a shameful experience to two confederates using a neutral (i.e., not self-compassionate) prompt
15781626|NCT04600557|Behavioral|Receiving no response from confederates|Following the participant's description of a shameful experience, two confederates will not be allowed to provide any verbal response
15781627|NCT04600544|Other|Non-interventional|Translational, observational study
15781628|NCT04600531|Device|1x1 Low Intensity Transcranial Direct Current Stimulation (tDCS)|"tDCS will be delivered through a pair of identical square rubber electrodes (size 35 cm2), placed in rectangular saline-soaked sponges. For the stimulation of M1, electrodes will be placed over C3 or C4 according to the 10-20 EEG system, matching with the M1 contralateral to the performing dominant hand. The reference electrode will be positioned on F1 or F2, ipsilateral to the dominant hand.
~The current stimulation will be slowly ramped up from 0 mA to 2 mA in one minute. For the anodal tDCS condition, this intensity will be maintained for the duration of the SRT-task (approximately 20 minutes). This will result in a current density of 0,057 mA/cm2. For the sham tDCS condition - unbeknown to the subject - stimulation will be gradually decreased towards 0 mA immediately after the one-minute ramp-up. During the last block of the SRT-task, this gradual ramping-up and -down of the current stimulation will be repeated to optimize the process of blinding of participants."
15781629|NCT04600531|Device|4x1 Multichannel Stimulation Adapter for High Definition Transcranial Direct Current Stimulation (HD tDCS)|"HD tDCS will be delivered over M1. By connecting the conventional tDCS device (described above) to this adapter, the direct current is delivered along the 4x1 HD tDCS configuration, allowing for more specific neuromodulation. Stimulation is delivered by means of one central gel-electrode and four return-electrodes placed in plastic encasings embedded in an EEG cap.
~Stimulation of left M1 (right hand = performing): delivered via the central electrode corresponding with C3 and held in place using a synthetic cap to hold the HD-tDCS electrodes on the head. Return-electrodes are positioned at Cz, F3, T7 and P3 (10-20 EEG system).
~Stimulation of right M1 (left hand = performing): central electrode will be positioned at C4 with the return-electrodes at Cz, F4, T8 and P4.
~Strategies for anodal and sham stimulation are identical to the ones described above (conventional tDCS)."
15781630|NCT04600505|Drug|Treatment A|Participants will receive 2 inhalations of BGF MDI with propellant 1.
15781631|NCT04600505|Drug|Treatment B|Participants will receive 2 inhalations of BGF MDI with propellant 2.
15781632|NCT04600505|Drug|Treatment C|Participants will receive 2 inhalations of BGF MDI with HFA propellant.
15781633|NCT04600492|Drug|Riociguat Oral Tablet|Take any dose of Riociguat from 0.5mg to 2.5mg, or placebo
15781655|NCT04600323|Drug|Placebo|Participants will be given placebo at 0.5 mEq/kg-LBW/day for 12 months
15781634|NCT04600479|Diagnostic Test|Evaluation of the prevalence of HCV, HBV and HIV viral infections|"Assessment of prevalence HCV, HBV and HIV prevalence estimations. Sociodemographic and clinical data will be collected from the patient's medical record and through self-questionnaires completed by the patient. A systematic screening by 3 RDTs (HCV, HBV and HIV) will be proposed in the specific framework of the SaPHIR study.This is a screening performed on capillary blood (TOYO VHC ®, TOYO VHB ® and INSTI HIV 1 / HIV 2 ®), to obtain a result in less than 30 minutes.
~In case of confirmation of the diagnosis of viral hepatitis or HIV infection, the final result will be transmitted and explained to the patient by the referring doctor, who will organize the adapted care pathway and prescribe the DAA for the simple patients. The complex patients will be referred to the specialist to consider starting an appropriate treatment.
~Evaluation of care pathway and barriers to care for hepatitis C. Only patients with positive HCV RDT participating in this follow-up."
15781635|NCT04600466|Other|Molecular testing for all participants.|Molecular testing on formalin fixed paraffin-embedded (FFPE) tissues on retrospectively identified patients with gastric adenocarcinoma.
15781636|NCT04600466|Other|Germline Testing|Germline testing will be done on prospectively identified patients and in retrospectively identified patients who are still alive.
15781637|NCT04600466|Other|Survey|Survey will be administered on prospectively identified patients and in retrospectively identified patients who are still alive. Survey will be administered in person or via telephone. The survey in the language of the participants choice (English or Spanish) on sociodemographic information, current and/or prior PPI (proton pump inhibitor), H2 blocker, antibiotic, tobacco, alcohol, and recreational drug use. Questionnaire will include other risk factors for gastric adenocarcinoma such as certain dietary constituents (high salt diet, high consumption of processed meat, etc.) and occupational exposures.
15781638|NCT04600453|Other|Physical Exercise|The intervention will consist of a multicomponent exercise training programme24, which will be composed of supervised progressive resistance exercise training, balance-training and walking for 4 consecutive days. During the training period, patients will be trained in 20 min sessions twice a day. The supervised multicomponent exercise training programme will be comprised of upper and lower body strengthening exercises, tailored to the individual's functional capacity, using weight machines and aiming for 2-3 sets of 8-10 repetitions at an intensity of 40-60 % of 1RM combined with balance and gait retraining exercises that progressed in difficulty and functional exercises, such as rises from a chair. The second part of the session will consist of functional exercises such as knee extension and flexion, hip abduction, balance movements, and daily walking in the hospital.
15781639|NCT04600440|Biological|Convalescent plasma|Plasma donated from patients recovered from Covid-19 and having high titres of antibodies
15781640|NCT04600427|Procedure|Epidural anesthesia|T11-12 epidural blockade with 0.25% bupivacaine continuous infusion.
15781641|NCT04600414|Other|Collaborative Care for Mental Health Disorders|CoCM is based on six key principles: 1) evidence-based, 2) measurement-based, 3) team-based, 4) population-based, 5) patient-centered, and 6) accountable. CoCM supports the delivery of evidence-based pharmacological and psychosocial treatments. CoCM is measurement-based with screening and monitoring of patient-reported outcomes over time to assess treatment response and facilitate treatment adjustments. CoCM is team-based led by a primary care provider with support from a care manager in consultation with a psychiatrist who provides treatment recommendations for patients who are not responding. CoCM is population-based whereby a registry is used to monitor treatment engagement and facilitate the identification of patients falling through the cracks. CoCM is patient-centered with proactive outreach to engage and activate patients. Collaborative care is accountable with continuous quality improvement to meet clinic performance benchmarks.
15781642|NCT04600414|Other|Collaborative Care for Opioid Use Disorder|"Pharmacologic treatment of OUD will rely mainly on transmucosal buprenorphine/naloxone prescribed by primary care providers with DATA 2000 waivers. Measurement-based care and treat to target are fundamental principles of CoCM and will be incorporated into the intervention. Care managers will ask four yes/no questions about: 1) opioid withdrawal symptoms, 2) illicit opioid craving, 3) illicit opioid use, 4) medication side effects. If necessary, consulting psychiatrists will then recommend a change to the treatment plan to the primary care provider. In the case of buprenorphine/naloxone, options for changing the treatment plan include: 1) increasing the dosage (max dose 32mg), 2) augmenting with clonidine, 3) switching to injectable buprenorphine, and/or 4) intensifying psychosocial interventions. If the patient is experiencing medication side effects, but not opioid withdrawal symptoms or illicit opioid craving, consideration will be given to lowering the medication dosage."
15781643|NCT04600401|Other|Mentis Plus+ (Experimental Group)|"Each factor can be considered a module, so it is a modular program. So, each module has 3 sessions to be carried out in full. It is a systematic program, so the order of the sessions is regulated by the letters A, B and C for each module. The modules to be worked on correspond to the low-level or languising factors identified after the application of the positive mental health questionnaire (PMHQ). After the application of the PMHQ, people are grouped with the same module to work."
15781644|NCT04600388|Device|Nerivio|Nerivio Remote Electrical Neuromodulation (REN) device
15781645|NCT04600375|Behavioral|Verbal consultation|Verbal consultation only without written information before receiving written action plan
15781646|NCT04600375|Behavioral|Written Action Plan|Written handout of treatment plan and disease management strategies
15781647|NCT04600362|Drug|Experimental: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]|Subcutaneous
15781648|NCT04600349|Behavioral|Identity Oriented Psychotrauma Therapy|The method will be presented to the group at the beginning of the first group session. Then every person from the experimental group will set an Intention connected to the emotional or physical difficulties they experience in their lives. Then the person will choose for every word in their Intention, a representative from the support group who will resonate with that word. The focus of every Intention should be the current illness and the traumatic or stressful events which happened before the disease onset.
15781649|NCT04600349|Drug|Treatment as Usual|The participants randomised in this group will continue taking the classical treatment prescribed for Hashimoto (Levothyroxine)
15781650|NCT04600336|Drug|Oxybutynin Chloride|Given PO
15781651|NCT04600336|Drug|Placebo Administration|Given PO
15781652|NCT04600336|Other|Quality-of-Life Assessment|Ancillary studies
15781653|NCT04600336|Other|Questionnaire Administration|Ancillary studies
15781654|NCT04600323|Drug|Sodium Bicarbonate Tablets|Participants will be given sodium bicarbonate at 0.5 mEq/kg-LBW/day for 12 months
15781658|NCT04600297|Device|ELS Even Stronger (3D Printed Resin Composite)|Missing of one premolar cases will be restored using the 3D Printed resin composite (ELS Even Stronger, Saremco, Switzerland). The steps of the procedure: Preparation, scanning, colour determination, design of the restoration, printing the restoration, adjusting occlusion, finishing and polishing, cementation.
15781659|NCT04600284|Drug|AD-2101|AD-2101 16/5mg
15781660|NCT04600284|Drug|AD-2102|AD-2102 25mg
15781661|NCT04600284|Drug|AD-2101 + AD-2102|AD-2101 16/5mg + AD-2102 25mg
15781662|NCT04600271|Drug|Crystalloid Solutions|exposure
15781663|NCT04600271|Drug|Colloid Blood Volume Expanders|exposure
15781664|NCT04600271|Other|blood replacement|exposure
15781665|NCT04600271|Drug|Diuretic|exposure
15781666|NCT04600271|Drug|noradrenaline|exposure
15781667|NCT04600271|Drug|Non-Steroidal Anti-Inflammatory Analgesics|exposure
15781668|NCT04600258|Dietary Supplement|Dark Chocolate|The patients will receive 40g per day of dark chocolate for 2 months
15781669|NCT04600245|Procedure|Evaluation of CARTOSOUND-FAM software for accurate three-dimensional reconstruction of the left atrium in patients referred for atrial fibrillation ablation.|One group will undergo the procedure with assistance from the CartoSound-FAM system and the other with the M-FAM system. Data will be collected from all subjects during the ablation procedure and post procedure for a period of 12 months. Either CartoSound-FAM or M-FAM software systems alongside Carto Merge 3D reconstruction will be used during the treatment for atrial fibrillation. Data will be anonymized by removing patient protected health information, only initials will be used
15781670|NCT04600232|Diagnostic Test|Alere TB-LAM|Subjects also undergo clinical evaluation including CT, sputum smear, Gene Xpert and mycobacterial culture.
15781671|NCT04600206|Other|Self-report questionnaires|"In this longitudinal cohort study, patients and caregivers will not receive an intervention. In addition to the outcomes named in the section Outcome Measures patients and caregivers will complete self-report questionnaires for
~Existential distress (Demoralization Scale-II, Death and Dying Distress Scale, Depressive Experiences Questionnaire, Revised Loss Orientation and Life Engagement in Advanced Cancer Scale, Sense of Dignity Item, Patient Dignity Inventory, Marwit-Meuser Caregiver Grief Inventory, Caregiver Guilt Questionnaire)
~Need for and utilization of psychosocial support
~Resources (Sources of Meaning and Meaning in Life Questionnaire, Questionnaire on the Defiant Power of the Human Spirit) and
~Control variables (Memorial Symptom Assessment Scale, PHQ-9 and GAD-7)"
15781672|NCT04600193|Other|Diet containing organic phosphate|The patients will be receiving a 5 days diet containing organic phosphate
15781673|NCT04600193|Other|Diet containing inorganic phosphate|The patients will be receiving a 5 days diet containing inorganic phosphate
15781674|NCT04600180|Procedure|sigmoidoscopies and and venous blood sampling|Sigmoidoscopies will be performed at baseline and during immunotherapy. During these procedures biopsies will be taken from the sigmoid and rectum. At the same timepoints, venous blood samples will be taken.
15781675|NCT04600167|Drug|Isoniazid and Rifapentine (INH-RPT)|Oral combination of rifapentine (RPT, 900 mg) and isoniazid (INH, 900 mg), once-weekly for 12 weeks.
15781676|NCT04600167|Drug|Placebo|Participants in the control group will receive placebo once weekly for 12 weeks
15781677|NCT04600154|Drug|MS-20|Specific fraction from fermented soy milk
15781678|NCT04600154|Other|Placebo|Fermented soy milk without active component
15781679|NCT04600141|Drug|Tocilizumab|Tocilizumab infusion 8mg/kg/dose - Intravenous single dose.
15781680|NCT04600141|Drug|Heparin - Therapeutic dosage|Intravenous Non-Fractional Heparine (HNF) starting at 18UI/kg/h adjusted according to a nomogram to achieve an Activated Partial Thromboplastin Time (ATTP) from 1.5 To 2.0 times the reference Value; or Low Molecular Weight Heparin (LMWH) subcutaneous dosage of 1mg/kg per dose every 12 hours
15781681|NCT04600141|Drug|Heparin - Prophylactic dosage|Subcutaneous Non-Fractional Heparine 5000U every 8 hours OR Subcutaneous Low Molecular Weight (LMWH) 40mg/day.
15781682|NCT04600128|Other|Dairy-based greek yogurt|Plain Greek yogurt (2% M.F; Danone, Boucherville, Quebec, Canada)
15781683|NCT04600128|Other|Dairy-based cheddar cheese|Mild cheddar cheese (31% M.F. ; Armstrong, Saputo Dairy Products, Saint-Laurent, Quebec, Canada)
15781684|NCT04600128|Other|Plant-based yogurt|Plain Greek yogurt alternative (Daiya, Rupert Street, Vancouver, Canada)
15781685|NCT04600128|Other|Plant-based cheese|Medium cheddar style block (Daiya, Rupert Street, Vancouver, Canada)
15781686|NCT04600115|Drug|Adenosine|Adenosine: 0.14mg/kg/min for 6 min. IV injection for MRI perfusion
15781687|NCT04600115|Drug|Regadenoson|0.4mg in 5ml, given as a rapid (10 seconds) IV injection for MRI perfusion.
15781688|NCT04600115|Drug|O-15 labeled radioactive water|O-15 labeled radioactive water: Up to 50mCi IV injection at rest and again at hyperemia for PET Imaging
15781689|NCT04600115|Device|MRI|Pass dynamic contrast enhanced MRI scans will be performed at rest and during hyperemia caused by either adenosine infusion or regadenoson
15781690|NCT04600115|Device|PET Imaging|Quantitative PET imaging with O-15 labeled radioactive water will be given at a different day
15781691|NCT04600102|Device|Structure Sensor|A 3D representation of each participant's lower limb geometry will be obtained using a Structure Sensor scanner (Occipital, Inc.) which uses an infrared structured light projector to construct a 3D image of an object. The scanner is connected to an iPad; to operate the user rotates the iPad camera around the desired object. In seconds, the entire geometry is digitally reconstructed.
15781692|NCT04600089|Drug|Saline|Saline infusion
15781693|NCT04600089|Drug|Ketamine|Continuous ketamine infusion at a dose of 0.2 mg/kg/hr, initiated at the induction of anesthesia and continued for 48 hours postoperatively.
15781694|NCT04600076|Behavioral|BabyCenter site and the community group|Participants will be asked to sign on to the BabyCenter community group for people with pregnancy or infant loss at least 3 times weekly for 6 weeks. Participants may choose to post or comment on the site but are not required to do so.
15781929|NCT04597749|Diagnostic Test|Home Sleep Apnea Test with FDA cleared devices|In-lab HST test
15781695|NCT04600063|Procedure|Isolation procedure (RAMPS procedure)|In the Isolation procedure group, the transection of the root of the splenic artery and the pancreatic transection are performed first, followed by the transection of the splenic vein (mandatory procedure). At that time, the branch from the splenic artery (dorsal pancreatic artery), the branch to the splenic vein (left gastric vein, inferior mesenteric vein), and short gastric arteriovenous are also disconnected as soon as possible (recommended procedure). An operation to lift up the pancreatic neck from the dorsal portal vein or superior mesenteric artery to expose the splenic vein (so-called tunneling) is allowed. After that, lymph node dissection such as hepatoduodenal mesentery (No12), common hepatic artery perimeter (No8), lymph node dissection around SMA (No14p) was performed (recommended procedure), and at the end of the resection operation, the pancreas body/tail and spleen are mobilized and removed (required procedure).
15781696|NCT04600063|Procedure|Conventional procedure|In the conventional procedure group, first, the pancreatic body and tail and spleen are mobilized (mandatory procedure), and the regional lymph nodes of the body and tail of the pancreas, such as the hepatoduodenal mesentery (No12 lymph node) and the common hepatic artery perimeter (No8), are removed. (Recommended procedure) and dissection of lymph nodes (No14p) around SMA (Recommended procedure), and after dissection of the gastro-splenic ligament and pancreas, transection of the splenic vein at the end of the resection procedure (required procedure) . However, in order to prevent bleeding and secure a safe field of view, early pancreatotomy is allowed.
15781697|NCT04600050|Other|usual care and exercise education|Provide exercise training materials after the education of exercise and health to enable home-based exercise
15781698|NCT04600050|Other|Eccentric exercise|Under the face-to-face supervisor, the eccentric exercise using a flywheel, and the self-directed home-based eccentric overload exercise using an elastic band are performed.
15781699|NCT04600037|Drug|Pregabalin 150mg|"Patients in group I received pregabalin at a dose of 75 mg twice daily during the first week that was increased to 150 mg twice daily thereafter and maintained at that level for 12 weeks.
~Patients in two groups received exercise therapy (stretching exercises for the trapezius muscle). Patients were instructed to perform 10 repetitions three times a day., 3 months"
15781700|NCT04600024|Diagnostic Test|Ultrasound guided diagnostic injection|4 cc lidocaine %2 injection into the piriformis muscle was performed for the diagnosis of piriformis syndrome. It was performed by the ultrasound-guidance to increase the accuracy of the injection.
15781701|NCT04600011|Other|Physical and occupational therapy (PT/OT)|"Neurologic-specialized and -certified physical and occupational therapists will provide each participant with an initial in-person PT/OT evaluation/treatment session with oversight from a Movement Disorders Neurologist, followed by 4 virtual home visits with tele-PT/OT and care partner supervision every 2 weeks, and culminating with a final in-person evaluation, all with a focus on personalized training in core areas contributing to a patient's individual fall risk, much like in-person visits. Virtual home safety surveillance with the mobile virtual platform is an additional feature of this intervention that aims to optimize the home environment to reduce external factors contributing to fall risk."
15781702|NCT04600011|Other|Home Safety Evaluation (HSE)|The VIRTUAL HOME SAFETY EVALUTIONS (HSE)-ONLY ARM where participants ONLY receive the virtual home safety evaluations and surveillance that are built into the original protocol of three of the four tele-OT visits that is being used in Arm 1. The study duration for Arm 2 is about 6 weeks of the primary intervention as described with 3-month and 6-month follow-up calls. The mobile virtual platform for Arm 2 is comprised of a tablet OR smartphone that will be guided through the home by the care partner only and not the patient.
15781703|NCT04599998|Diagnostic Test|spirometry, thoracic CT, CPET, 6 minute walking test, SF-36 questionnaire|Participants will perform spirometry, lung diffusion capacity of carbon monoxide, 6-minute walk test (6MWT), Short form-36 (SF-36) questionnaire and cardiopulmonary exercise testing (CPET) after 6-12 months (Visit 1) of COVID-19. Clinical, laboratory and chest image data during the COVID-19 hospitalization will be obtained from medical records.
15781704|NCT04599985|Other|star excursion balance training (SEBT)|The SEBT is aimed to be maintained the single limb stance on one leg while reaching farthest possible with the swing leg. An individual can reach farthest with the swing leg while maintaining the balance on the stance leg
15781705|NCT04599985|Other|Simplified star excursion balance training (SSEBT)|It is one of the training protocols, in a simplified way, with respect to star excursion balance test. It consists a series of reaching tasks for the lower limbs in three-directions i.e., anteromedial, medial and posteromedial.
15781706|NCT04599972|Drug|CSF-1|One drop bilaterally twice daily for approximately 2 weeks.
15781707|NCT04599972|Drug|Vehicle|One drop bilaterally twice daily for approximately 2 weeks.
15781708|NCT04599959|Diagnostic Test|Sampling of SARS-CoV-2 RNA from nasopharyngeal swab specimen or saliva collected via Salivette Cortisol|Kylt® for detection/confirmation of SARS-CoV-2 cobas® SARS-CoV-2 (PCR) test TaqPath™ COVID-19 CE-IVD RT-PCR kit
15781709|NCT04599946|Dietary Supplement|Infant formula and follow-on formula made from whole goat milk|Infant formula and follow-on formula made from whole goat milk
15781710|NCT04599946|Dietary Supplement|Infant formula and follow-on formula made from cow's milk ingredients|Infant formula and follow-on formula made from cow's milk ingredients
15781711|NCT04599933|Drug|CSF-1|One drop bilaterally twice daily for approximately 2 weeks.
15781712|NCT04599933|Drug|Vehicle|One drop bilaterally twice daily for approximately 2 weeks.
15781713|NCT04599920|Dietary Supplement|Partial replacement of red meat with legume-based foods|560 g of cooked and boneless red meat is replaced with legume-based foods providing the equal amount of protein.
15781714|NCT04599907|Device|Roll-In Cohort: Single Application of N-SWEAT Patch|Single Application of N-SWEAT Patch in both axillae for 10 subjects
15781715|NCT04599907|Device|Randomized Cohort: Single Application of N-SWEAT Patch|Single Application of N-SWEAT Patch in both axillae for subjects randomized to the treatment group
15781716|NCT04599907|Device|Randomized Cohort: Single Application of Sham Patch|Single Application of Sham Patch in both axillae for subjects randomized to the control group
15781717|NCT04599894|Drug|37.5mg Pregabalin + 75mg Pregabalin|37.5mg pregabalin preoperatively + 75mg pregabalin postoperatively
15781718|NCT04599894|Drug|75mg Pregabalin|75mg pregabalin postoperatively
15781719|NCT04599881|Drug|PTR-01|IV recombinant collagen 7 at 3 mg/kg given weekly for 4 doses, followed by bi-weekly for 7 doses
15781955|NCT04597502|Other|Topical Terminalia Chebula|Applied to both forearms and dorsal hands
15781720|NCT04599868|Drug|magnesium sulfate|"Patients will be assessed hourly for pulse and blood pressure, contraction frequency, vaginal bleeding. With strict monitoring for symptoms of magnesium sulfate toxicity.
~All patients will receive dexamethasone to enhance fetal lung maturity. RH status will be determined for all patients, . Hb level will be measured and anemic patients will receive correction by blood transfusion Cervical length will be measured after 24 h& 48 h from administration of magnesium sulfate in both groups Maternal serum magnesium will be measured at admission and after 4 hours ,12 hours and 24 hours after administration of magnesium sulfate Patients of both groups will be assessed for their neonatal outcomes include deaths and gestational age at delivery, fetal birth weight. Apgar score at five minutes, neonatal ICU admission and duration of admission and neonatal calcium level at time of delivery will be also assessed."
15781724|NCT04599842|Procedure|Erector Spinae Plane Block|Erector Spinae Plane block is performed by giving local anesthetic to the plan between the erector spinae muscle and the transverse process.
15781725|NCT04599829|Device|AnkleSTRONG100/500/900|At least 30 patients (15 patients in the orthosis group and 15 patients in the control group) per device type (3 device types: Ankle STRONG 100/500/900) totalling 90 patients will be included. Patients included in the orthosis group will use the device during sports sessions while patients included in the control group will not use an ankle support device.
15781726|NCT04599816|Drug|levosimendan at a dose of 3 mcg/kg|levosimendan will be administered intravenously at a dose of 3 mcg/kg after anesthesia induction
15781727|NCT04599816|Drug|levosimendan at a dose of 6 mcg/kg|levosimendan will be administered intravenously at a dose of 6 mcg/kg after anesthesia induction
15781728|NCT04599816|Drug|levosimendan at a dose of 12 mcg/kg|levosimendan will be administered intravenously at a dose of 12 mcg/kg after anesthesia induction
15781729|NCT04599803|Device|Verily Sleep Apnea (VSA) Program/App|The VSA program/app, is an Obstructive Sleep Apnea (OSA) management platform.
15781730|NCT04599790|Drug|TACE combined with lenvatinib and sintilimab|Lenvatinib 12mg (body weight ≥60kg) or 8mg (body weight <60kg) P.O. qd and sintilimab 200mg I.V. q3w will be started at 3-7 days after the first TACE.TACE will be repeated if clinically indicated. Treatment of sintilimab will last up to 24 months. Patients will be allowed to have lenvatilib or sintilimab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.
15781731|NCT04599777|Drug|TACE combined with sorafenib and tislelizumab|Sorafenib (400mg P.O. Bid) and tislelizumab (200mg I.V. q3w) will be started at 3-7 days after the first TACE. TACE will be repeated if clinically indicated. Treatment of tislelizumab will last up to 24 months. Patients will be allowed to have sorafenib or tislelizumab as a sigle agent and will be still considered on study when the other drug cause intolerable toxicity.
15781732|NCT04599764|Other|HD-tDCS|Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation tool that alters cortical excitability and activity via application of weak direct currents.The respective excitability alterations-enhancement by anodal and reduction by cathodal tDCS-can last for over an hour after the end of stimulation.
15781733|NCT04599764|Other|computer-based cognitive training|Computer-based cognitive training (CCT) is a potentially important tool for individuals at risk of dementia. Cognitive training in healthy older adults and those at risk of dementia has been linked to benefits in cognitive functioning.
15781734|NCT04599751|Device|Hair removal treatment|Axilla and bikini line hair removal treatments using the Trio Laser Module (Alma Lasers).
15781735|NCT04599738|Other|Wheat muffin|Participants consumed a control muffin made of wheat flour.
15781736|NCT04599738|Other|Finger millet grain muffin|Participants consumed a test muffin made of finger millet grain and wheat flour.
15781737|NCT04599725|Drug|medical abortion|medical abortion
15781738|NCT04599712|Drug|Amivantamab|Amivantamab will be administered intravenously at the recommended doses based on weight (1050 milligram [mg] or 1400 mg) once weekly for the first 4 week cycle (1 cycle equals to 28 days), then every 2 weeks thereafter.
15781739|NCT04599699|Radiation|Stereotactic Body Radiation Therapy (SBRT)|Very Low, Low, favorable, or Good Prognostic Intermediate prostate cancer:SBRT; Unfavorable, or Poor Prognostic Intermediate prostate cancer: SBRT accompanied 4 months ADT;High or Very High prostate cancer: SBRT accompanied 2 years ADT.
15781740|NCT04599686|Drug|ADT|On the day of enrollment, luteinizing hormone-releasing hormone agonist (LHRHa) was given for ADT.
15781741|NCT04599686|Radiation|SBRT|Evaluating men with oligometastatic prostate cancer lesions randomized to stereotactic body radiation therapy (SBRT) (3-5 fractions).
15781742|NCT04599673|Drug|AMNIOGEN|"AmnioGen® amnion matrix allograft is a bioactive tissue matrix processed from 100% human amniotic tissue. The allograft is processed with advanced technology so the graft can be suspended in liquids and applied through needles and syringes.
~Amniotic tissue is composed of structural extracellular matrix, which is rich in various types of collagen, growth factors, cytokines, and specialized proteins. Thus, the application of amniotic tissue is known to modulate localized tissue inflammation, reduce scar tissue formation and promote the healing of soft tissue."
15781743|NCT04599673|Other|normal saline|10 ml normal saline
15781744|NCT04599660|Other|Treatment of Low Risk GISTs according clinical practice (includes drugs, surgery or any other received treatments)|This observational study collects all the treatments received by the patients according clinical practices or experimental trials and therefore includes drug/biological/surgical and any other applicable treatments
15781745|NCT04599647|Biological|PVSRIPO|PVSRIPO (5x10^7 TCID50) delivered intratumorally via convection enhanced delivery (CED).
15781956|NCT04597502|Other|Topical Placebo|Applied to both forearms and dorsal hands
15781749|NCT04599621|Diagnostic Test|Collection of blood samples to determine the level of certain cytokines (TNF-α, IL-1β, IL-4 and IL-10),Collection of blood samples to determine the level of uric acid|Collection of blood samples to determine the level of certain cytokines (TNF-α, IL-1β, IL-4 and IL-10) All study participants had blood in the morning on fasting after 8-12 hours of fasting from the cubital vein. Determination of the level of cytokines TNF-α, IL-1β, IL-4 and IL-10 in blood serum by enzyme-linked immunosorbent assay (ELISA). All participants in the study had blood drawn in the morning on fasting after 8-12 hours of fasting from the cubital vein. The level of uric acid was determined on the CYAN Start apparatus using a unified method.
15781750|NCT04599595|Device|Peristeen (Coloplast)|"Patients with severe intestinal dysfunction impairment (PAC QoL score ≥ 32) will be offered the adoption of the TAI (Transanal Irrigation) with Peristeen Device as a way to manage their own evacuation, replacing any other measure used until that moment (suppositoires, clisms exceptionally cc) with the exception of the possible intake of macrogols and/or prebiotics and/or probiotics which instead patients can continue. This treatment will be proposed to all patients with severe impairment of intestinal function.
~The TAI training with Peristeen will be carried out at the surgical clinic of the Surgical Department of the Ferrara University Hospital, Italy, by the health personnel involved in the study, usually in a single session, but more sessions may be necessary, with the continuation of the TAI for 4 weeks or with patient's exclusion from the study if the guarantees of appropriate use of the device will not be reached."
15781751|NCT04599582|Device|Hip Arthroplasty|Patients are operated with hip replacement.
15781752|NCT04599569|Device|indirect calorimetry|indirect calorimetry with and without renal replacement therapy
15781754|NCT04599543|Drug|IL3 CAR T-cells|Each subject receive IL3 CAR T-cells by intravenous infusion
15781755|NCT04599530|Device|Talaris Demonstrator|The Talaris Demonstrator will be evaluated during daily activities and compared to the current prosthesis
15781758|NCT04599491|Device|Sidestream capnography using the 'Respironics LoFlo Sidestream CO2 Module'|Study patients randomized into the 'Sidestream capnography' arm will receive postoperative ventilation on the ICU with INTELLiVENT-ASV with sidestream etCO2 monitoring using the 'Respironics LoFlo Sidestream CO2 Module'.
15781759|NCT04599491|Device|Mainstream capnography using the 'Respironics Capnostat 5 Mainstream CO2 sensor'|Study patients randomized into the 'Mainstream capnography' arm will receive postoperative ventilation on the ICU with INTELLiVENT-ASV with mainstream etCO2 monitoring using the 'Respironics Capnostat 5 Mainstream CO2 sensor'.
15781760|NCT04599478|Drug|Naltrexone and Bupropion medication|NB medication will be taken daily in pill form.
15781761|NCT04599478|Behavioral|Behavioral Weight Loss|Behavioral Weight Loss (BWL) counseling includes weekly sessions.
15781762|NCT04599478|Other|Placebo|Placebo will be inactive and taken daily in pill form.
15781763|NCT04599465|Drug|ELX/TEZ/IVA|Fixed dose combination (FDC) tablet for oral administration.
15781764|NCT04599465|Drug|IVA|Tablet for oral administration.
15781765|NCT04599452|Biological|Allogeneic NK cell regimen group|"10 patients with recurrent refractory elderly AML were treated with allogeneic NK cell regimen.
~Allogeneic NK cell regimen ×3 cycle; Cyclophosphamide 300mg/m2.d d1to 3; G-CSF 150ug bid d4-11; Azacitidine 75mg/m2 d5-11; Allogeneic NK cell 10-30×10^6/kg d13，d15."
15781766|NCT04599439|Diagnostic Test|Cardiac magnetic resonance imaging|All patients will undergo a cardiac magnetic resonance test to calculate their border zone channel (BZC) mass. This will not be used to decide further interventions, but all the patients will be treated according to standards of care.
15781767|NCT04599426|Biological|Allogeneic NK cell regimen group|"10 patients with refractory MDS-RAEB were treated with allogeneic NK cell regimen.
~Allogeneic NK cell regimen ×3 cycle; Cyclophosphamide 300mg/m2.d d1to 3; G-CSF 150ug bid d4-11; Azacitidine 75mg/m2 d5-11; Allogeneic NK cell 10-30×10^6/kg d13，d15 ."
15781768|NCT04599413|Other|SURVEY|Pain survey on pianists
15781769|NCT04599400|Other|There is no intervention in our study|There is no intervention in our study
15781770|NCT04599387|Other|Remote Exercise Prescription|Exercise sessions will follow the recruitment meeting as prescribed by the BioGradient system, and will be tailored to the patient progress and limitations. In the beginning of each exercise session safety criteria will be collected and will allow participation . In addition, every 8 weeks and during the first exercise session outcome measurements will be collected . The study coordinator will initiate a phone call every 8 weeks to collect session data and discuss progress and limitation with the participant.
15781771|NCT04599387|Other|Usual Care|Exercise sessions will be initiated by the patient only. In the beginning of each exercise session safety criteria will be collected and will allow participation . Every 8 weeks and once after recruitment outcome measurements will be collected . The study coordinator will initiate a phone call every 8 weeks to collect outcome session data
15781772|NCT04599374|Other|no intervention|This study collected data only without any intervention.
15781773|NCT04599348|Dietary Supplement|HRG 80 Red Ginseng|A unique form of ginseng with the high level of active ginseng components similar to those found in the wild ginseng used in earlier studies.
15781774|NCT04599335|Device|2% HA|2% HA
15781775|NCT04599322|Other|Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis Muscle|Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis Muscle
15781776|NCT04599296|Device|Hip brace|Hip brace
15781777|NCT04599283|Device|MenHealth Uroflowmeter|MenHealth Uroflowmeter is a mobile application and FDA cleared medical device that analyzes the sound of urine hitting the toilet water when a male urinates and generates voiding data (maximum flow, average flow, and voided volume) and a flow curve. All test results are saved in an automated voiding diary.
15781778|NCT04599270|Other|PREVENTURE Program|Adolescents will be follow PREVENTURE program (2 session of 90 min).
15781779|NCT04599270|Other|Routine care|Adolescents will be follow routine care
15781780|NCT04599257|Device|BTL-899|The device applicator combines high-intensity focused electromagnetic procedure and radiofrequency energy to induce visible muscle contractions along with heating of the subcutaneous fat.
15781781|NCT04599244|Other|emergency pulpotomy|removal of coronal pulp
15781782|NCT04599231|Diagnostic Test|Quality of Recovery -15|The investigators plan to evaluate patients' quality of recovery at postoperative day (POD) 1, 2, and 3.
15781783|NCT04599218|Other|Prostate Biopsy|Standard of care
15781784|NCT04599218|Other|MR US Fusion Guided Prostate Biopsy|Trans-rectal ultrasound (TRUS) guided fusion prostate biopsy (Arm 1) or a Transperineal Ultrasound guided fusion prostate biopsy (Arm 2). All patients will under go a standard ultrasound guided biopsy at the time of their targeted (fusion) biopsy.
15781785|NCT04599218|Device|MR/TRUS Fusion Guided Prostate Biopsy|TRUS images are overlaid on a previously obtained prostate MRI, combined with an electromagnetic tracking system. The urologist then performs directed prostate biopsies at MR-identified targets in addition to the standard prostate biopsies.
15781786|NCT04599205|Drug|Tranexamic acid|fractional co2 laser, microneedling and topical tranexamic acid gel
15781787|NCT04599192|Other|No study intervention|The study does not determine any interventions. Any intervention performed during coronary angiography is considered standard of care.
15781788|NCT04599179|Device|self-expandable metal stent|self-expandable metal stent endoscopic positioning
15781789|NCT04599166|Behavioral|Who Would You Choose: Serious Fun|"Who Would You Choose: Serious Fun is a conversation activity that prompts players (using scenarios and metaphors) to choose a spokesperson whose qualities are best suited to the role. At the end of the activity, players identify a real-life spokesperson based on the qualities considered during gameplay."
15781790|NCT04599153|Other|Ventriculoperitoneal shunt opening pressure setting|The ventriculoperitoneal shunt (Strata®) opening pressure can be changed using a magnetic tool. The possible settings are 0.5, 1.0, 1.5, 2.0, 2.5 with a higher setting number corresponding to a higher opening pressure and less drainage through the shunt. All settings are used in routine clinical practice.
15781791|NCT04599140|Drug|CXCR1/2 Inhibitor SX-682|Given PO
15781792|NCT04599140|Biological|Nivolumab|Given IV
15781793|NCT04599127|Other|Mobilization with movement|The physical therapist will adjust the active movement of the shoulder joint during the arm elevation or abduction and shoulder external rotation
15781794|NCT04599127|Other|Conventional physical therapy|The exercise is tailor-made and each participant will be performing some of the exercises based on the list that physical therapist prescription
15781795|NCT04599114|Behavioral|VIRTUES|VIRTUES is a digital health platform that offers 2 way communication between clinicians and patients to address symptoms stemming from atrial fibrillation.
15781796|NCT04599101|Device|Nose Frida nasal suction device|Caregivers will be given a Nose Frida device to remove the child's nasal secretions.
15781797|NCT04599101|Device|Bulb syringe nasal suction device|Caregivers will be given a bulb syringe device to remove the child's nasal secretions.
15781798|NCT04599088|Other|Brain functional MRI with simplified urodynamics|"Structural:
~MPRAGE provides a structural image, which is used for coregistration of subjects. Structural scans are then performed including Diffusion Spectrum Imaging (DSI; microstructural), and Fluid-attenuated inversion recovery (FLAIR; white matter specific) scans.
~Functional:
~With about 50 ml in the bladder, resting state functional BOLD measurements are made, followed by functional whole-brain images while a small amount of saline is infused and withdrawn from the bladder, in 2 blocks of 4 repetitions each. Each repetition starts with a 12-scan pause, followed by infusion (6 scans = 12 s), pause (6 scans), and withdrawal (6 scans). Each block of 4 repetitions is completed by a 6 scan pause during which scanning continues. 24 ml is infused at 120 ml/min, and slightly less is withdrawn to avoid accommodation.This is repeated on an empty and full bladder along with a resting state image."
15781799|NCT04599075|Drug|Insulin|IV Insulin Infusion
15781800|NCT04599075|Drug|Insulin|Continuous Subcutaneous Insulin Infusion (Pump)
15781801|NCT04599062|Drug|Talimogene Laherparepvec|Talimogene Laherparepvec
15781802|NCT04599062|Radiation|Radiotherapy|Concurrent Preoperative Radiation. External Beam Radiation Therapy (EBRT) will be given at the standard dose for resectable soft tissue sarcomas. according to the NCCN sarcoma guidelines.
15781804|NCT04599036|Device|MARK|EMG controlled arm orthosis
15781805|NCT04599023|Device|MSPT|The MS Performance Test (MSPT) software tool and accompanied hardware is an iPad®-based assessment tool, developed via collaboration between Biogen and the Cleveland Clinic Mellen Center, and designed to objectively quantify the major motor, visual and cognitive function data, and quality of life outcomes, associated with MS and related disorders.These assessment modules of the MSPT are self-administered by MS patients at the point of care and incorporate and expand upon previously validated measures of the MSFC.
15781806|NCT04599010|Other|Dietary intervention|Calorie-restricted diet
15781807|NCT04598984|Diagnostic Test|serum adipokines|Level of serum adipokines will be measured with flow cytometry
15781808|NCT04598958|Other|IMPROVE|Health system interventions that include: (1) Multidisciplinary integrated management teams to coordinate patient-focused and outcome-oriented PMTCT and MCH services; (2) Enhanced Positive Health, Dignity, and Prevention (PHDP)-focused counseling and skills-building training and job aids; and (3) Increased early community-based counseling and support for first (antenatal care clinic) ANC attendees
15781809|NCT04598945|Other|Functionel MRI|During the activation fMRI sequences, the subject will perform target pointing tasks, that is to say that he will have to reach, by controlling a cursor using a non-magnetic joystick, targets projected onto a display screen. In each of the pointing tasks he will have to reach the target as quickly and as precisely as possible, and stay in the center of it for a long time times reached.
15782024|NCT04596995|Drug|Rozanolixizumab|Study participants receive rozanolixizumab by subcutaneous infusion during the Treatment Periods.
15781810|NCT04598932|Device|Brillouin microscopy|The Brillouin clinical instrument is comprised of three parts: a human interface, a laser-scanning confocal microscope, and an etalon-based spectrometer. The human interface is a modified ophthalmic slit-lamp instrument with chin support and headrest. The light source is a single longitudinal mode CW laser at 780 nm. A polarizing beam splitter and quarter-wave plate assembly sends the laser beam to the human interface. To focus light into the eye, a long-working distance microscope objective is used. Brillouin scattered light from the eye is collected with a single-mode optical fiber. For spectral analysis, a two-stage VIPA-etalon spectrometer configured with the cross-axis cascade principle and the spectrum is measured on a EM-CCD camera.
15781811|NCT04598919|Drug|Saracatinab|125 mg once daily by mouth for 24 weeks
15781812|NCT04598919|Drug|Placebo|once daily by mouth for 24 weeks
15781813|NCT04598906|Behavioral|Virtual environment rehabilitation|The participants attended 10-15 computer sessions during 6-12 weeks. Each session lasted 30 minutes and consisted of the set of virtual environment tasks (Shooting Range,Virtual Supermarket Shopping Task and Objects). Shooting range demands differentiation of targets from non-targets and focuses on training of selective attention, psychomotor speed and inhibition control. Virtual Supermarket Shopping requires memorizing the shopping list and searching for products in the supermarket area. Objects requires memorizing of the spatial and temporal context while searching for objects.
15781814|NCT04598906|Behavioral|Paper-pencil rehabilitation|The participants in the paper-pencil rehabilitation attended 10-15 paper pencil sessions for 6-12 weeks. Each session lasted 45 minutes. Each paper-pencil session starts with a warm-up game. The session continues with a set of paper-pencil tasks focused on attention, fine motor skills, recall, short-term and long-term memory, verbal fluency, visual search, cognitive flexibility, abstraction and executive functions, numerical abilities. The tasks are adapted according to the participant´s abilities.
15781815|NCT04598893|Biological|Teplizumab|Received teplizumab in PROTECT Study
15781816|NCT04598893|Other|Placebo|Received placebo in PROTECT study
15781817|NCT04598880|Drug|Polyethylene glycol + ascorbate|Pleinvue® is administered orally in 2 doses (3 sachets) as per SmPC within the previous 18 hours to colonoscopy intervention. First dose is administered at 9 pm on the day before intervention (sachet 1: MACROGOL 3350 100 g + SODIUM SULFATE ANHYDROUS 9 g + SODIUM CHLORIDE 2 g + POTASSIUM CHLORIDE 1 g). Second dose is administered 5 hours before intervention and it is composed by 2 sachets (sachet A: MACROGOL 3350 40 g + SODIUM CHLORIDE 3,2 g + POTASSIUM CHLORIDE 1,2 g; sachet B: SODIUM ASCORBATE 48,11 g + ASCORBIC ACID 7,54 g).
15781818|NCT04598880|Drug|Sodium picosulfate + magnesium citrate|Citrafleet® is administered orally in 2 doses (2 sachets) as per SmPC within the previous 18 hours to colonoscopy intervention. First dose (sachet 1) is administered at 9 pm on the day before intervention. Second dose (sachet 2) is administered 5 hours before intervention. Sachets 1 and 2 have the same composition: SODIUM PICOSULFATE 10 mg + MAGNESIUM OXIDE 3,5 g + CITRIC ACID 10,97 g.
15781819|NCT04598867|Drug|CD-008-0045|CD-008-0045 20 mg capsules
15781820|NCT04598867|Drug|Placebo|Placebo capsules
15781821|NCT04598867|Drug|Afobazol|Afobazol 10 mg tabletes
15781822|NCT04598854|Device|Intravascular laser irradiation of blood|Low intensity intravascular laser irradiation of blood phototherapy is a method of a 632.8 nm red light penetrate into a vein through fiber and the brightness is 100 fold of the sun. The light accelerates blood and cells circulation in the human body, so that protein molecular structure would promote changes.
15781823|NCT04598854|Device|Intravascular laser irradiation of blood (Sham)|zero intensity of the laser energy
15781824|NCT04598841|Dietary Supplement|supplement nutritional supporting|Special medical formula for the purpose of formula food
15781825|NCT04598828|Device|Non-invasive brainstem stimulation|Study participants will self-administer ~19-minute treatments twice daily in the home setting using a non-invasive brainstem modulation device. The device has been deemed as a nonsignificant risk for studies in Parkinson's disease by the United States Food and Drug Administration.
15781826|NCT04598815|Drug|Sirolimus|Group Sirolimus and Placebo: Patients will receive a first dose of Sirolimus of one 2 mg tablet on the first day, given approximately at 10 am, followed by 0.5 mg tablet per day for 12 weeks. At the end of the 12th week, a 12-week wash-out period will follow. At the end of the wash-out period patients will be given 1 tablet/day of placebo for 12 weeks Group Placebo and Sirolimus: Patients will receive 1 placebo tablet per day for 12 weeks, given approximately at 10 am. At the end of the 12 weeks, a 12-week wash-out period will follow. At the end of the wash-out period patients will be given a first dose of Sirolimus of one 2 mg tablet on the first day, followed by 0.5 mg tablet per day for 12 weeks
15781827|NCT04598802|Device|covered stent|atherosclerotic aorto-iliac aneurysm
15781828|NCT04598789|Other|no intervention|no intervention, observational study
15781829|NCT04598763|Other|smell the odors of the olfactory rehabilitation kit according to the classic or intensive method|regardless of the randomization group, the patient will smell each odor for 10 seconds with a 10 second interval between odors.
15781830|NCT04598737|Procedure|Ultra-translucent multilayer zirconia|Ultra-translucent multilayer zirconia laminate veneer treatment
15781831|NCT04598737|Procedure|Lithium disilicate|Lithium disilicate laminate veneer treatment
15781832|NCT04598724|Other|Surveys|Survey will be administered involving questions regarding knowledge and perception of palliative care.
15781833|NCT04598711|Behavioral|RLIC|See descriptions under arm/group descriptions. RLIC is delivered for 14 visits. Visits 1-3 occur on consecutive work days and visits 4-14 occur on alternating week days.
15781834|NCT04598711|Behavioral|Sham Conditioning|See descriptions under arm/group descriptions. Sham conditioning is delivered for 14 visits. Visits 1-3 occur on consecutive work days and visits 4-14 occur on alternating week days.
15781835|NCT04598711|Behavioral|Muscle Power training|All participants undergo power training of the quadriceps muscles using unilateral and bilateral leg presses (Total Gym GTS, San Diego, CA), 3 times/week for 4 consecutive weeks (12 sessions). Power training will follow standard American College of Sports Medicine guidelines for frequency, intensity, progression etc. Power training is provided at visits 3-14.
15781836|NCT04598711|Behavioral|Balance training|All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-14.
15781837|NCT04598711|Behavioral|Treadmill Training|All participants will undergo short burst interval treadmill training using self-selected and fast walking speeds.
15781838|NCT04598672|Behavioral|Cognitive behavioral therapy for insomnia (CBTi)|Patients will undergo a 7 sessions course in cognitive behavioral therapy for insomnia.
15781839|NCT04598646|Behavioral|Cardio-oncology Rehabilitation (CORE)|Exercise therapy, CVD risk factor management for the first 6 months (as per current standards in CR models) and behavioural support for the entire 2-year intervention period
15781840|NCT04598646|Behavioral|Support|Behavioural support via professionals and peer support.
15781841|NCT04598646|Behavioral|Passive Behavioural Support|Passive behavioural support, either PAI-Score or recommended physical activity guidelines for cancer survivors, to encourage physical activity.
15781842|NCT04598633|Dietary Supplement|Lactobacillus reuteri Prodentis®-lozenges (DSM 17938, ATCC PTA 5289)|Supplementary intake of Lactobacillus reuteri Prodentis®-lozenges (DSM 17938, ATCC PTA 5289) 2 times per day for 12 weeks
15781843|NCT04598633|Dietary Supplement|Placebo-lozenges (BioGaia)|Placebo-lozenges (BioGaia) 2 times per day for 12 weeks
15781844|NCT04598607|Drug|Hypidone Hydrochloride tablets|30mg(10mg×3), 40mg(10mg×4) or 50mg(10mg×5) Hypidone Hydrochloride tablets will be given orally once on day 1, day 9 and twice a day on day 3~8.
15781845|NCT04598607|Drug|Placebo|3, 4 or 5 tablets of placebo will be given orally once on day 1, day 9 and twice a day on day 3~8.
15781846|NCT04598594|Drug|Patch, Nicotine|Two patches of 7 mg/day Treatment at 14 mg/day during mechanical ventilation since after first successful extubation then, dose decreasing: Week 1: 10,5 mg/day Week 2 : 7 mg/day Week 3 : 3,5 mg/day
15781847|NCT04598594|Drug|Patch, Placebo|Two patches of 7 mg/day Treatment at 14 mg/day during mechanical ventilation since after first successful extubation then, dose decreasing: Week 1: 10,5 mg/day Week 2 : 7 mg/day Week 3 : 3,5 mg/day
15781848|NCT04598581|Radiation|Low Dose Radiation Therapy (LD-RT)|Low Dose Radiation Therapy (LD-RT) of both lungs with 1 Gray
15781849|NCT04598581|Other|Sham irradiation|Sham irradiation
15781850|NCT04598568|Device|balanSys UNI|Implantation of a balanSys UNI knee prosthesis implanted with a spacer block surgical technique
15781851|NCT04598542|Drug|Lorecivivint (LOR)|0.07 mg
15781852|NCT04598542|Drug|Triamcinolone acetonide (TA)|40 mg
15781853|NCT04598529|Other|A2 milk|a variety of cow's milk that contains only A2 beta-casein (and therefore lacks of A1 beta-casein).
15781854|NCT04598529|Other|Conventional milk|cow's milk with a mixture of A1 and A2 beta-casein.
15781855|NCT04598516|Diagnostic Test|serum creatinine assay|peak change in serum creatinine in a period of 5 days from baseline (day 0) will be determined
15781856|NCT04598503|Other|full history and clinical examination|For each case, a detailed perinatal and maternal and family history were obtained by interviewing questionnaire. Diagnosis of congenital anomalies was based on clinical evaluation of newborn babies by the neonatologist and other appropriate investigations such as radiography, ultrasonography, echocardiography and chromosomal analysis etc... Classification of anomalies is done by systems according to WHO international classification of diseases (ICD10) [10]. Data was entered into excel data sheet and appropriate statistical analysis was performed. The prevalence was calculated by dividing the number of CA during the 6 months (173) by the total number of admission during this period (753).
15781857|NCT04598490|Device|Space closure into old extraction space|Lower first premolar extraction space was closed using elastic power chain and 0.019X0.025 Stainless steel archwire into healed bony socket
15781858|NCT04598490|Device|Space closure into recent extraction space|Lower first premolar extraction space was closed using elastic power chain and 0.019X0.025 Stainless steel archwire into fresh bony socket
15781859|NCT04598477|Biological|efgartigimod PH20 SC|Subcutaneous injection of efgartigimod using rHuPH20 (PH20) as a permeation enhancer
15781860|NCT04598477|Drug|prednisone|Oral prednisone tablets
15781861|NCT04598464|Other|Home based exercise|The home-based training program included posture and stretching exercises, strengthening exercises, balance training, and a walking regimen 3 days per week for 3 months.
15781862|NCT04598451|Biological|efgartigimod PH20 SC|Subcutaneous injection of efgartigimod using rHuPH20 (PH20) as a permeation enhancer
15781863|NCT04598451|Other|Placebo|Subcutaneous injection of placebo
15781864|NCT04598451|Drug|prednisone|Oral prednisone tablets
15781865|NCT04598438|Behavioral|Music behavioral early intervention program|The program consists of carefully designed play-based enhancement strategies implemented in the form of hybrid online/in-person playgroups. Following a teach-model-coach-review approach, parents will learn to implement various skills that are expected to enhance infant's language and communication skills through singing and engaging in musical play with their child at home.
15781866|NCT04598438|Behavioral|Arts and crafts early enhancement program|The program follows the same general structure with the music intervention program. Parents will learn how to implement a series of arts and crafts activities at home, with an aim to enhance infant's visual-perceptual, motor, and sensory integration development.
15781867|NCT04598425|Behavioral|Cognitive behavioral therapy for insomnia (CBTi)|Patients will undergo a 7 sessions course in cognitive behavioral therapy for insomnia.
15781868|NCT04598412|Other|No intervention|Cross-sectional
15781869|NCT04598399|Behavioral|Mindfulness Based Relapse Prevention|7 x 60-120 minute sessions with different themes: Automatic pilot/triggers/relapse/high-risk situations/ mindfulness in daily life. There will be a welcoming time, with a focus on at-home practice and difficulties, a theoretical presentation of new concepts, practical meditation exercises and a debriefing.
15781870|NCT04598399|Behavioral|Relaxation/ meditation|7 x 60-120 minute sessions each with a different sound from nature with unguided, closed relaxation group with a maximum of 12 participants
15781871|NCT04598386|Other|PR Lotion - AMP Human Performance|Sodium Bicarbonate Topical Solution. For use of the PR Lotion solution, consumers are instructed to apply the lotion to areas of the body that have been identified as most likely to use during their activity (i.e. calves and thighs for runners, shoulders and forearms for swimmers, etc.). Moreover, the product can be applied up to 2 hours prior to beginning a workout or event with one use supporting a 4-6 hour workout. AMP Human has also verified the safety of their product as being well tolerated in consumers >2 years of age unless there is a known allergy to an ingredient on the label. Moreover, to the company's knowledge no side effects have been reported per the SAFETY Section at https://amphuman.com/pages/faq.
15781930|NCT04597749|Other|Non-Contact Screening App|Non-Contact Sleep Apnea Screening Applications at bedside table to assess for sleep apnea.
15782111|NCT04596267|Drug|Pitolisant|8.9mg Pitolisant for 5 days
15781872|NCT04598386|Other|Placebo Lotion|Placebo Topical Solution. Lotion will be created by the AMP Human Performance company and will include all ingredients similar to the PR Lotion product except for the exclusion of sodium bicarbonate.
15781873|NCT04598373|Behavioral|interdisciplinary treatment|Interdisciplinary treatment (IDT) distinguishes itself as an interdisciplinary-coordinated (e.g., physician, occupational therapist, physiotherapist, and psychologist) intervention using a bio-psycho-social view of chronic pain. The MMR continues over a lengthy period with a common goal and generally includes patient education, supervised physical activity, simulated work training, and cognitive behavioural therapy (CBT). The exact composition of these MMR components depends on initial evaluations of the patients health status and furhter follow-up testing. The MMR interventional components can act independently and interdependently, resulting in combined effects due to known and unknown mechanisms; the effects are intended to be greater than the sum of its components.
15781874|NCT04598360|Procedure|Heart-Lung-Machine|blood sample before and during a single Heart-Lung-Machine procedure
15781875|NCT04598321|Drug|Talazoparib Oral Capsule|An orally available PARP inhibitor for the treatment of advanced breast cancer with germline BRCA mutations.
15781876|NCT04598308|Diagnostic Test|absolute flow and resistance measurements|"This registry only collects all measurement data from normal/routine physiologic assessment in the cathlab. These measurements are performed on a daily basis
~Short description of the procedure Coronary angiography, PCI (if indicated), and physiologic measurements are performed completely according to normal routine. Physiologic measurements may include FFR, NHPR, IMR, CFR, absolute flow (Q) and microcirculatory resistance (Rmicro or MRR) measurement.
~Intention to measure Q and Rmicro are mandatory to be included in this registry.
~Use of drugs either during or after the procedure should also exactly identical to normal routine."
15781877|NCT04598295|Drug|DS-01|synbiotic
15781878|NCT04598282|Device|Prokera Slim|Placement of an Adjunctive Cryopreserved Amniotic Membrane Treatment.
15781879|NCT04598282|Other|Standard of Care|Standard of care includes epithelial debridement of all dendrites via Weck-Cel Cellulose sponge, topical prophylactic antibiotics (e.g., Ocuflox QID for one week) and oral acyclovir (400 mg 5x/day for 10 days for primary cases but tapered to 2x/day for 3 months for recurrent cases based on investigator's discretion).
15781880|NCT04598269|Drug|ATI-1777|ATI-1777 topical solution 2.0% w/w
15781881|NCT04598269|Drug|Vehicle|Vehicle topical solution
15781882|NCT04598256|Procedure|Endoscopic procedure|Esophagogastroscopy and colonoscopy
15781883|NCT04598243|Dietary Supplement|Smart Energy System|A nutritional /herbal combination
15781884|NCT04598230|Behavioral|Cognitive Behavioral Therapy (CBT)|Participants randomized to this arm will receive up to 20 sessions of evidence based cognitive behavioral therapy (CBT) of extended duration, with more exposure tasks and greater family involvement than has been studied in the past.
15781885|NCT04598230|Drug|Combination therapy (COMB)|Participants randomized to this arm will receive cognitive behavioral therapy comparable to that in the cognitive behavioral therapy arm, plus one of three selective serotonin reuptake inhibitors (SSRI) medications (fluoxetine, sertraline, escitalopram)
15781886|NCT04598217|Other|anesthesiologist|non-interventional observational
15781887|NCT04598204|Drug|Treatment with oral rapmycin|To treat the enrolled patients with oral rapamycin with an initial dosage of 0.8mg/m2, once daily for children under 3 years old and twice daily (every 12 hours) for those above 3 years, and adjust the dosage to target a trough concentration of rapamycin in plasma as 10-15ng/ml （OR 15-20ng/ml if the efficacy of treatment is not satisfactory）. One course lasts for 12weeks and no more than 4 course is given.
15781888|NCT04598191|Drug|Iloprost|"Participants in Iloprost group will be administered aerosolized 20 μg iloprost in 15 min through a nebulizer connected to the inspiratory limb of the respiratory system when the internal mammary artery harvesting is done."
15781889|NCT04598191|Drug|Control (Normal saline)|"Participants in Control group will be administered aerosolized 5 ml of normal saline in 15 min through a nebulizer connected to the inspiratory limb of the respiratory system when the internal mammary artery harvesting is done."
15781890|NCT04598165|Behavioral|Interactive two-way SMS dialogue|We will utilize Mobile WACh, a human-computer hybrid system that enables seamless two-way SMS communication and patient tracking, to provide consistent support to women and their infants during the peripartum period and 6 weeks into the baby's life. Women will receive automated theoretically grounded SMS messages targeting the appropriate peripartum period and will have the capability to respond and spontaneously message a nurse based at the clinic. During pregnancy, automated SMS will be delivered weekly. Two weeks prior to the participant's estimated due date (EDD), daily messaging will begin, and will continue for two weeks after delivery is ascertained. Thereafter, SMS will be delivered every other day for the remaining four weeks. Women who experience pregnancy or infant loss will be enrolled into an infant loss track where they will receive messages of support.
15781891|NCT04598152|Device|TDCS - transcranial direct current stimulation|TDCS involves passing a weak current through the brain. One variant, cathodal TDCS, can be used to temporarily hyperpolarize cortical pyramidal cells, thereby decreasing neuronal connections. TDCS has been explored as a possible treatment for depression, but results to date are mixed. No work has examined whether TDCS can be used in an individually guided manner to target locations in the parietal cortex and alter the patterns of circuitry dysfunction described previously.
15781893|NCT04598126|Other|Traditional physical therapy|Traditional physical therapy Ultrasound posteriorly 6 mints 4 days/week hydrocollateral pack anteriorly 10 mints 4 days/week Quadriceps isometrics 10 repetitions×1 set, 4 days/week and Hamstring muscle strechings 10 repetitions×1 set, 4 days/
15781894|NCT04598126|Other|patient education manual +traditional physical therapy|"Patient educational Manual
~+ Traditional physical therapy Ultrasound posteriorly 6 mints 4 days/week hydrocollateral pack anteriorly 10 mints 4 days/week Quadriceps isometrics 10 repetitions×1 set, 4 days/week and Hamstring muscle strechings 10 repetitions×1 set, 4 days/"
15781924|NCT04597788|Other|Conventional low calorie diet program|Low calorie diet consists of 1200 to 1500 calories will be educated and lifestyle modification will be encouraged for participants in control group. Educational materials as well as recipes for low calorie diet will be provided in individual sessions. Mobile counseling will also be offered for sticking to the diet program.
15781925|NCT04597775|Drug|hydroxychloroquine|hydroxychloroquine
15781926|NCT04597762|Drug|Cyclosporin|Cyclosporin eyedrops
15781895|NCT04598113|Device|Cervical Traction Device|"While The patient is lie on the back his or her head is housed within the specific head portion of the device. The investigator inflate progressively the device using a valve and ensuring the patient's relaxation. The process of inflation is continued until the level of 12 Kg of pressure is reached. This maximum level of traction is maintained for 10 minutes then the process of deflation is started until the pressure decreased to 0 Kg. This maneuver is reproduced once again after 5 minutes of rest.
~The balance assessment using the force plate-from is done just before the intervention and 5 minutes after its end."
15781896|NCT04598100|Behavioral|FOCUS-EC|
15781898|NCT04598074|Other|Opioid Package Prototype (OPP)|The Opioid Package Prototype (OPP) is a child-resistant/senior-friendly, calendar-blister packaging of limited pill counts with flat readable billboard space for medication labeling.
15781899|NCT04598074|Other|Usual Care (standard amber vial)|The standard amber vial (orange bottle) is the container that medication is normally dispensed in outside of the study.
15781900|NCT04598061|Drug|Dexmedetomidine IV|Dexmedetomidine IV
15781901|NCT04598048|Behavioral|Questionnaire|Patients will complete an EQ-5D questionnaire, medication and lifestyle questions
15781902|NCT04598035|Diagnostic Test|Diagnostic Tests|"Blood and Urine laboratory tests
~ECG and blood pressure for cardiovascular measurements
~Self-report questionnaires about pain"
15781903|NCT04598022|Other|cross-sectional observation|observation of dietary patterns, body weight status, microbiome and metabolome profiles at the start of the first semester
15781904|NCT04598022|Other|cross-sectional follow-up observation|follow-up observation of dietary patterns, body weight status,microbiome and metabolome profiles after one year
15781905|NCT04598009|Drug|Binimetinib|Taken orally (PO) twice a day (BID)
15781906|NCT04598009|Drug|Imatinib|Taken orally (PO) once a day (QD)
15781907|NCT04597996|Other|web based education for student and parents|"Web-based education will include modules on the following subjects;
~Mental health literacy knowledge level
~Improving help-seeking behavior
~Avoiding self-stigmatization in seeking psychological help"
15781908|NCT04597983|Dietary Supplement|2S-hesperidin|Cardiose® is a natural orange extract that due to its unique manufacturing process, maintains most of the natural hesperidin isomeric form (2S)
15781909|NCT04597983|Dietary Supplement|Placebo|Microcellulose was used, this molecule was selected to avoid affecting the glycemia, as it can occur with dextrose or maltodextrin.
15781910|NCT04597970|Drug|cTACE-HAIC|transarterial chemoembolization (TACE) plus Hepatic Arterial Infusion Chemotherapy (HAIC) with oxaliplatin and raltitrexed for Barcelona stage C hepatocellular carcinoma (HCC)
15781911|NCT04597957|Dietary Supplement|Fresh Rx Intervention group|"Fresh Rx Intervention participants will be able to fill their prescription at the FQHC based Farmers Market for fresh produce up to eight times during the 15-week Fresh Rx program. The provided debit cards will be loaded with the $10 stipend at each visit. At each market session, cooking demonstrations will take place that reinforce healthy food options and how to prepare foods that were available at the Mercado.
~All control group participants will be given flyers describing all the health and wellness programs at the FQHC including the Mercado. Control group participants will receive a $10 gift card to a national brand pharmacy (no fresh produce available). The enrollment time for the control group will overlap with the Fresh Rx group. After a 3-month time period, the control group will follow up and be given a $20 gift card to the same national brand pharmacy."
15781912|NCT04597931|Drug|Romosozumab|SC Romosozumab 210 mg/monthly
15781913|NCT04597931|Drug|Zoledronic Acid|IV Zoledronic acid 5 mg
15781915|NCT04597892|Diagnostic Test|serum creatinine assay|point-of-care and standard laboratory assay of serum creatinine
15781916|NCT04597866|Behavioral|Multimodal rehabilitation|A combination of exposure in vivo and interventions directly targeting the cortical reorganization for treating CRPS.
15781917|NCT04597853|Diagnostic Test|Assessment of lung mechanics and heart-lung interactions|Impedance tomography, right-heart catheterization, oesophageal pressure measurements, indirect calorimetry and classic mechanical ventilation parameters
15781918|NCT04597840|Procedure|Incisional hernia repair with reinforcement of biosynthetic mesh|The biosynthetic mesh (Phasix or Bio-A meshes) will be placed as a sublay in the retromuscular position to reinforce midline fascial closure. All the surgical procedure (including placement and fixation of the mesh) will be performed according to a standardized protocol.
15781919|NCT04597840|Procedure|Incisional hernia repair with simple suture or synthetic mesh reinforcement.|Based on the discretion of the surgeon, the incisional hernia repair will be done by simple suture or by synthetic mesh reinforcement. All the surgical procedure (including placement and fixation of the mesh if applicable) will be performed according to a standardized protocol.
15781920|NCT04597827|Other|Metacognition tests|Test on episodic or semantic memory
15781921|NCT04597814|Other|No Intervention|No Intervention
15781922|NCT04597801|Drug|Alcon|Fluorescein sodium is administered intravenously with a bolus injection of 5 mg per kg of bodyweight 20-40 minutes prior to the planned tumor resection.
15781923|NCT04597788|Other|Protein supplemented very low calorie diet program|"Protein supplemented very low calorie meal is a shake-type meal replacement with total calories of 600 to 800 calories per day and proteins provided at 1.2g of ideal body weight per day. The four-month, very low calorie diet program schedule will be as follows. In the first two weeks, all three meals are replaced, followed by two meals replaced and one meal in food in the next six weeks, and one meal replacement is recommended for the next eight weeks. For the next eight months, the intermittent very low calorie meal replacements will be provided regularly for one week a month. If a subject gains weight more than 2kg, he or she will have an additional 1 week of two meal replacements, and if a subject gains weight more than 4kg, he or she should have an additional 2 weeks of replacement.
~Individual sessions will be held 11 times during the study. Mobile counseling with dietitians or nurses will be offered to help subjects lose weight and maintain weight loss."
15781927|NCT04597762|Drug|Hydrocortisone|Hydrocortisone eyedrops
15781928|NCT04597749|Diagnostic Test|PSG|In-lab sleep polysomnography test
15781931|NCT04597736|Biological|Biological collection with nasopharyngeal samples, saliva, blood, stool and urine|"Subjects with a COVID-19 infection and their contact cases (identification according to health insurance criteria, see Améli.fr) will be offered a clinical evaluation and the takin of biological samples, whether they are hospitalized or via the outpatient screening channel.
~For the main objective: during the Day0 visit, the subjects who agreed to participate in the study will have a clinical evaluation according to a standardized questionnaire and a nasopharyngeal swab, saliva, blood, stool and urine.
~For secondary objectives : longitudinal follow-up will be carried out for 21 days, for index cases and contact cases, whether they have a positive or negative RT-PCR test on D0. A final consultation will be carried out at M3. Nasopharyngeal samples, saliva, blood, stool and urine will be taken on D10 and D21. A blood test will be taken at M3 to carry out a COVID-19 serology."
15781932|NCT04597723|Drug|oxygen|Patients will be given different concentrations of oxygen.
15781933|NCT04597710|Genetic|utility of whole genome sequencing (WGS) to aid clinical decision making in patients referred for liver resection|All participants will attend their planned outpatient surgery appointment.The consultant will document the intended treatment plan for each participant in line with their usual care pathway.Following this, participants will be required to attend three dedicated study visits:The results of the MRI scans from Study Visit 1 will be analysed into a LiverMultiScan report.A report will be sent to the consultant who will review their original documented care plan alongside the LiverMultiScan report.The consultant may update the intended care plan as a result of the LiverMultiScan report, in line with the device CE-marking.Any changes to the care plan will be documented.The patient will then undergo their planned treatment.The tumour explant will be collected and samples will be stored, transported and processed for genetic sequencing and digital histopathology.Study Visit 2 will be performed remotely 12 months following their planned treatment,where patient reported outcomes will be collected
15781934|NCT04597697|Drug|Insulin icodec|Insulin icodec will be investigated in participants with impaired liver function and subjects with normal liver function. Administered as a single dose subcutaneously (under the skin) The study will last for about 8 weeks.
15781935|NCT04597684|Procedure|Cementless Total Knee Arthroplasty|Total Knee Arthroplasty (TKA) with cementless knees
15781936|NCT04597684|Procedure|Cemented Total Knee Arthroplasty|Total Knee Arthroplasty (TKA) with cemented knees
15781937|NCT04597671|Drug|Durvalumab|Durvalumab is used as standard of care
15781938|NCT04597671|Radiation|low-dose PCI|PCI will be given concurrently with durvalumab. PCI will be given to a dose of 15 Gy in 10 fractions
15781939|NCT04597658|Behavioral|Bodyweight supported treadmill training (BWSTT)|In the BWSTT group, walking training will be given by asking the patients to walk on the treadmill as fast as they can, without exceeding the medium intensity according to the Borg scale. Bodyweight support will be gradually reduced according to the patient's tolerance.
15781940|NCT04597658|Behavioral|Conventional rehabilitation|The conventional rehabilitation program includes posture and breathing exercises, lower extremity stretching, active-assistive range of motion and strengthening, balance-coordination exercises, and walking with a physiotherapist on a smooth surface.
15781941|NCT04597645|Other|Therapeutic elastic band resistance training|A16-week therapeutic program using Elastic Thera Band will be taught. The exercises are designed to train specific major muscle groups, strengthen the motivation of participants, and facilitate home-based compliance. The program will be performed two times per week (once supervised and guided by a trained physical therapist and the other supervised by educational trainers) over 16 weeks for a total of 32 sessions. Each session supervised by a physical therapist last for 60 minutes, including a 5-minute warm-up consisting of light-intensity aerobic and dynamic stretching exercises, followed by 50 minutes of EB exercise and a 5-minute period of cool-down and static stretching exercises.
15781942|NCT04597632|Drug|brolucizumab|brolucizumab 6 mg/0.05 mL solution for intravitreal injection
15781943|NCT04597619|Other|Novel Nonopioid Pathway|The novel nonopioid pathway consists of preoperative counseling, postoperative standardized orders and standard of care adjunctive and analgesic medications, specialized discharge instructions and written patient instructions regarding medications and activity.
15781944|NCT04597606|Other|Exercise with spontaneous ventilation.|"Patients will perform 10 minutes, constant load, exercise in a cycloergometer. To set the load, a baseline incremental effort test will be performed previously (VISIT 1).
~Then, in a separate day (VISIT 2), the subject will perform 10 minutes cycling at the 75% load of that determined as maximum in VISIT 1, at a constant rate of 30 to 35 pedal revolutions per minute, in spontaneous breathing, with low flow oxygen through conventional nasal cannula adjusted to achieve SpO2 between 92to 94%"
15781945|NCT04597606|Device|Exercise with NIV|VISIT 2 Non invasive mask ventilation: parameters will be titrated during a free cycling period at the end of the spontaneous breathing exercise. Then, in a separate day (VISIT 3), with the same constant load, cycling cadence and under NIV, the patient will perform 10 min of cycling.
15781946|NCT04597606|Device|Exercise with HFNC|With constant flows of 50 lpm and with FiO2 adjusted according to SPO2, to obtain a constant saturation between 92 and 94%. The same pedaling load and frequency will be maintained, with similar variables collected.
15781947|NCT04597567|Procedure|Metal removal|Implant removal after fracture consolidation after posterior fixation of thoracolumbar spine fractures
15781948|NCT04597554|Dietary Supplement|Cranberry|Cranberry beverage and gummies supplement
15781949|NCT04597554|Dietary Supplement|Placebo|Placebo beverages and gummies supplement
15781950|NCT04597541|Drug|AK112|AK112 is a PD1/VEGF bispecific antibody;AK112 is given by intravenous infusion.
15781951|NCT04597528|Other|Elective Induction|"All patients admitted to the labour room would be approached to be enrolled in the study.
~Those satisfying the inclusion and exclusion criteria would be prospectively enrolled to the study after procuring an informed consent. If a patient appears to meet the criteria for the study, she will be told about the study and asked for written informed consent to participate. Consent may be obtained anytime from 34 weeks 0 days to 38 weeks 6 days of gestation. Data would be procured on a pre set proforma, entered in real time and safely stored.
~The data would later be abstracted to an excel sheet."
15781952|NCT04597515|Procedure|Robot Breast reduction surgery|Breast reduction surgery, using a robot by removing a breast disc at the base
15781953|NCT04597502|Dietary Supplement|Terminalia Chebula fruit extract|Oral TC fruit extract supplement taken by mouth twice per day
15781954|NCT04597502|Dietary Supplement|Placebo|Oral placebo taken by mouth twice per day
15781957|NCT04597489|Procedure|Fractional flow reserve|Patients were stratified into the FFR group if a coronary angiography with adjunctive FFR measurement was performed during the index hospitalization.
15781958|NCT04597489|Procedure|Angiography-only|Patients were stratified into the angiography-only group if a coronary angiography without adjunctive FFR measurement was performed.
15781959|NCT04597476|Dietary Supplement|Fucoidan|Fucoidan refers to a class of fucose-enriched sulfated polysaccharides with an average molecular weight of 20,000 Daltons (Da), which can be found in many varieties of edible brown seaweeds and algae . In cell culture studies and animal studies, fucoidan has been shown to possess a range of biological activities, including anti-cancer, anti-inflammatory, and immunoregulatory effects . A recent in vitro study conducted in head and neck squamous cell carcinoma (HNSCC) cell lines (H103, FaDu, and KB) showed that fucoidan could induce cell cycle arrest and possibly apoptosis in a dose-dependent manner, while also enhancing response to cisplatin treatment . In addition, fucoidan has also been shown to inhibit the proliferation of nasopharyngeal carcinoma cells and MC3 human mucoepidermoid carcinoma (MEC) cells .
15781960|NCT04597476|Other|Placebo( Potato starch)|Potato starch 4.4gram
15781961|NCT04597463|Procedure|Endometrial injury|Endometrial injury was performed hysteroscopically after freeze all cycles and during the cycle before the frozen embryo transfer
15781962|NCT04597450|Drug|Lu AG06466|Lu AG06466 - 30 mg/day, capsules, orally, once daily, one capsule will be taken daily for 15 days per treatment period
15781963|NCT04597450|Drug|Placebo|Placebo - capsules, orally, once daily, one capsule will be taken daily for 15 days per treatment period
15781964|NCT04597437|Drug|Zanamivir|Intravenous zanamivir
15781965|NCT04597437|Other|Placebo|In the placebo group, participants will receive placebo normal saline solution intravenously every twelve hours for 5 days.
15781966|NCT04597424|Drug|Experimental: doxycycline|"2 tablets of doxycycline 100 mg (monohydrate form) will be taken orally after each risk sexual intercourse, ideally within 24 hours after sex and no more than 72 hours. PEP should not be taken more than 3 times over a 7 days' period.
~If a participant has risk sexual intercourse for several consecutive days, PEP should be taken at least 48 hours apart and no more than 3 times 2 tablets over 7 days. A maximum of 3 intakes of 2 tablets will be allowed over a period of 7 days."
15781967|NCT04597424|Biological|Bexsero® vaccine|1st injection of Bexsero® vaccine at inclusion visit, 2nd injection at week 8.
15781968|NCT04597411|Radiation|225^Ac-PSMA-617|administered intravenously under the dose de-escalation schedule
15781969|NCT04597411|Radiation|68^Ga-PSMA-11|administered intravenously at a dose of 111 - 185 MBq (3 - 5 mCi)
15781970|NCT04597398|Device|Evaluation of blood flow with indocyanine green|
15781971|NCT04597385|Other|Long-term Follow-Up|No intervention
15781972|NCT04597372|Drug|Tamsulosin|Study drug will contain 0.4 mg of Tamsulosin. Subjects will be provided with 10 capsules to be taken daily.
15781973|NCT04597372|Drug|Placebo|Placebo will be prepared by the IDS pharmacist (or contracted pharmacy) and encapsulated in identical appearing wraps. Subjects will be provided with 10 capsules to be taken daily.
15781978|NCT04597346|Device|Bronchoscopic Transparenchymal Nodule Access|Bronchoscopic Transparenchymal Nodule Access (BTPNA) is locating the lesion in the lung tissue guided by the bronchoscope navigation system (LungPro) in the natural lumen (bronchus), and automatically calculates the best point of entry (POE) and the best route to avoid blood vessels. An opening is made from the POE under the endoscope, and is extended with a balloon dilator. Combined with X-ray fluoroscopy, a sheath with a blunt-tip core is used in the lung parenchyma to reach the lesion site, and then biopsy diagnosis or treatment.
15781979|NCT04597333|Drug|Dinoprostone|Dinoprostone vaginal insert.
15781980|NCT04597333|Device|Cervical ripening balloon.|Double lumen cervical ripening balloon.
15781981|NCT04597320|Drug|Fentanyl|"The fentanyl group was prepared by 1ug/kg fentanyl in 5ml normal saline, assembled with 5ml injection, labeled as Anesthesia inducer."
15781982|NCT04597320|Drug|Esketamine|"The esketamine group was prepared by 0.5mg/kg esketamine in 5ml normal saline, assembled with 5ml injection, labeled as Anesthesia inducer."
15781983|NCT04597320|Drug|Midazolam|"Midazolam 0.05mg/kg+ Anesthesia inducer was applied to all patients for procedural induction by intravenous injection. According to the MOAA/S score of the patients, midazolam could be added 0.5mg per time at more than 2 minutes until the MOAA/S score reached 3, the maximum infusion dose of midazolam was less than 10mg and less than 0.1mg/kg."
15781984|NCT04597307|Combination Product|IN.PACT™ Admiral™ Drug Coated Balloon (DCB)|For percutaneous transluminal angioplasty (PTA) in subjects with obstructive disease of the peripheral arteries.
15781985|NCT04597294|Combination Product|FLOT4 + HIPEC + Surgery|HIPEC with irinotecan after 4 doses of preoperative FLOT4 chemotherapy
15781986|NCT04597294|Combination Product|FLOT4 + Surgery|Perioperative FLOT4 chemotherapy (4 doses before and 4 doses after gastrectomy) and surgery
15781987|NCT04597281|Other|Lifestyle intervention|The intervention group, will receive education on Mediterranean lifestyle (Mediterranean diet and physical activity promotion), combined with the provision of extra-virgin olive oil and fish, in order to be consumed at least 3 times per week. Physical activity sessions with a physical activity monitor will also be offered for free to the children (2 sessions of 60 minutes of moderate-vigorous physical activity, per week)
15781988|NCT04597268|Drug|Dexmedetomidine|intravenous dexmedetomidine 1 mic/kg
15781989|NCT04597268|Drug|Ketamine|ketamine 1mg/kg
15781990|NCT04597268|Drug|Midazolam|midazolam 0.05 mg/kg
15781991|NCT04597255|Device|Holographic optical coherence tomography|Descriptive wavefront analysis with holographic optical coherence tomography
15781992|NCT04597242|Drug|Exebacase|Patients will receive a single IV infusion of exebacase in addition to antistaphylococcal antibiotics prescribed by the treating physician. Patients with normal renal function or mild renal impairment will be administered a dose of 18 mg of exebacase; patients with moderate or severe renal impairment will be administered a dose of 12 mg; patients with end-stage renal disease, including those on hemodialysis, will be administered a dose of 8 mg.
15781993|NCT04597229|Dietary Supplement|Instant multigrain supplement|A twice daily instant multigrain supplementation for 12 weeks
15781994|NCT04597216|Device|sample of blood and saliva|sample of 3ml of blood by veinous puncture, of 1 drop of blood by needlestick, and of saliva by spitting
15781995|NCT04597203|Device|755-nm picosecond alexandrite laser with topical 2% hydroquinone|treatment one side of the face with 755-nm picosecond alexandrite laser with topical 2% hydroquinone
15781996|NCT04597203|Drug|topical 2% hydroquinone|treatment one side of the face with topical 2% hydroquinone
15781997|NCT04597190|Drug|Selective serotonin reuptake inhibitor|Prescribers and patients choose among three selective serotonin reuptake inhibitors (SSRI), sertraline, paroxetine, or fluoxetine based on patient's treatment history (i.e., failed SSRI trials due to side-effects or lack of efficacy) and preference. If a patient experiences problematic side effects after taking their choice of SSRI, the provider may switch them to another of the SSRI options during the first 8 weeks of follow-up. Patients on any antidepressant (including SSRIs) at enrollment will be cross-tapered over four weeks to either fluoxetine, sertraline or paroxetine (i.e., the old drug will be tapered down while the new drug is tapering up).
15781998|NCT04597190|Drug|Serotonin-norepinephrine reuptake inhibitor|Prescribers will prescribe venlafaxine.
15781999|NCT04597190|Behavioral|Written Exposure Therapy|Written Exposure Therapy will be delivered during six 30 minute sessions. The first session includes psychoeducation about symptoms of PTSD, provides a treatment rationale for approaching the trauma memory, and discusses the use of writing as a means of doing so. In sessions 2-6, patients will write about the memory of their worst traumatic event for 20 minutes, with a focus on details of the event and thoughts and feelings that occurred during the event. Patients are directed to write about the same trauma memory during each session. The session ends with the therapist instructing the patient to allow themselves to experience any trauma-related memories, images, thoughts, and feelings in the interval between sessions. The therapist reads the narrative between sessions to make sure instructions were followed. Feedback about the narrative is provided to the patient at the beginning of sessions 3-6. This feedback is used to prompt the patient for writing in the current session.
15782000|NCT04597177|Radiation|ST-IMRT SW-IMRT|
15782002|NCT04597151|Dietary Supplement|Dietary Intervention|Attend diet education sessions
15782003|NCT04597125|Drug|Radium-223 dichloride (Xofigo, BAY88-8223)|Participants will receive Radium-223 (BAY88-8223) every 4 weeks for a total of 6 administrations via intravenous (IV) injection
15782004|NCT04597125|Drug|NAH therapy|Participants will receive continuous NAH (either Abiraterone acetate plus prednisone/prednisolone [AAP] or enzalutamide) by mouth (per os) daily
15782005|NCT04597112|Other|Myofascial Release Technique|Myofascial release focuses on reducing pain by easing the tension and tightness in the trigger points. Therapist will gently massage the myofascia and feel for stiff or tightened areas. Normal myofascia should feel pliable and elastic. The therapist will begin massaging and stretching the areas that feel rigid with light manual pressure. The therapist then aids the tissue and supportive sheath in releasing pressure and tightness. The process is repeated multiple times on the same trigger point and on other trigger points until the therapist feels the tension is fully released.
15782006|NCT04597112|Other|Exercise|"Exercise is recommended by physical therapists for most cervical radiculopathy patients.
~In this study, a customized exercise program will be applied for patients with cervical radiculopathy."
15782007|NCT04597099|Drug|Micronized progesterone|oral micronized progesterone suspension, 100 mg oral dose at 0800 during each study admission
15782008|NCT04597099|Drug|Placebo|Placebo contains only inert ingredients and is not expected to exert any direct physiological effects.
15782009|NCT04597099|Drug|Flutamide|Flutamide, 250 mg taken orally twice daily for four weeks before study admission.
15782010|NCT04597099|Drug|Estradiol patch|Two 0.1 mg/day transdermal estradiol patches will be applied 3 days prior to each inpatient admission; on the morning of study admission, these two patches will be removed and immediately replaced with two new 0.1 mg/day patches.
15782014|NCT04597073|Procedure|Initial Periodontal Therapy|Oral hygiene education, including the use of toothbrushes and dental floss and/or interproximal brushes, was given to them. After one week Chronic Periodontitis group received nonsurgical periodontal therapy consisting of scaling and root planing (quadrant by quadrant) using manual scalers and curettes under local anesthesia. No antibiotics or any medications were prescribed during the treatment. Periodontal treatment was performed by the same investigator
15782015|NCT04597060|Device|Thermomechanical system with corticosteroids|The device in this study using Novoxel - Tixel®
15782016|NCT04597060|Other|corticosteroid injection|corticosteroid injection using TA 10mg/ml
15782017|NCT04597047|Diagnostic Test|Capillary Collection & Testing|Two (2) fingersticks will be performed on each subject and capillary blood tested in the LumiraDx SARS-CoV-2 Ab test
15782018|NCT04597047|Diagnostic Test|Venous Draw & Testing|One (1) Venous Draw (to include one (1) 6.0 mL EDTA tube and one (1) 3.5 mL serum separator tube) will be collected from each subject. Blood will be tested in the LumiraDx SARS-CoV-2 Ab test
15782019|NCT04597034|Procedure|AN69-Oxiris|To demonstrate clinical efficacy of AN69-Oxiris membrane to reach a stable MAP, with less vasopressor dosing (at least 0.1 micrograms/kg/min) after 72h of treatment, compared to a conventional membrane (standard AN69) in critically ill patients with AKI, COVID-19 infection and requirement of continuous renal replacement therapy.
15782020|NCT04597034|Procedure|AN69-Standard|Standard treatment.
15782021|NCT04597021|Device|use of a wiresless US transducer|to (evaluate the practicability of applying a wireless US transducer for central venous catheter-placement in these patients.
15782022|NCT04597008|Drug|Treatment group|Standard of Care + Local Vancomycin + Local Tobramycin: Participants in the treatment group will receive a dose of 1000mg of Vancomycin powder AND a dose of 1200mg of Tobramycin powder in their wound bed immediately before wound closure.
15782023|NCT04597008|Drug|Control group|Standard of Care + Local Vancomycin: Participants in the control group will receive a dose of 1000mg of Vancomycin powder in their wound bed immediately before wound closure.
15782025|NCT04596982|Other|Placement of IMPELLA®|ultrasound and hemodynamic parameters of patients in order to establish a predictive score for right-sided dysfunction after placement of IMPELLA®
15782026|NCT04596969|Other|Soluble Fiber Dextrin|Ingredient based on resistant starch
15782027|NCT04596956|Drug|sodium bicarbonate Ringer injection|Used in surgery
15782028|NCT04596956|Drug|Lactated Ringer's solution|Used in surgery
15782029|NCT04596943|Diagnostic Test|[68Ga]Ga-DOTA-(RGD)2 PET/CT|We have developed a dimeric cyclic RGD peptide conjugated with DOTA as a chelator. If labeled with the positron emitting radionuclide Gallium-68 (68Ga), [68Ga]Ga-DOTA-(RGD)2 can be used to visualize αvβ3 integrin expression with PET
15782030|NCT04596930|Procedure|Laser ablation thermal therapy|The Visualase Thermal Therapy System is used to necrotize or coagulate soft tissue through interstitial irradiation under MRI guidance
15782031|NCT04596917|Behavioral|Preferred music listening|The preferred music listening group will receive 15 minute patient-preferred music listening selection intervention in the Prep Room and unlimited music listening selection intervention in the PACU once cognitively ready until discharge criteria met.
15782032|NCT04596917|Behavioral|Relaxation breathing narrative over hypnotic music listening|The relaxation breathing group will receive the relaxation and breathing instructions over soft monotone hypnotic music in the PreOp unit before surgery and then in the PACU once cognitively ready to listen to the hypnotic music until discharge criteria met.
15782033|NCT04596904|Other|Lavender oil application group|Individuals, for 10 days, 3 drops of cotton drops of lavender oil, put on the shoulder parts, between 21:00 and 21:05 will smell every evening.
15782034|NCT04596904|Other|Distilled water application group|Individuals, for 10 days, 3 drops of cotton drops of distilled water, put on the shoulder parts, between 21:00 and 21:05 will smell every evening.
15782035|NCT04596891|Behavioral|Psychotherapy|Eight sessions of exposure therapy combined with mindfulness delivered via videoconferencing platform.
15782036|NCT04596878|Biological|GBS-NN/NN2|GBS-NN/NN2 bound to Alhydrogel as an adjuvant.
15782037|NCT04596878|Biological|Placebo|Normal Saline 0.9%
15782039|NCT04596852|Device|Assessment of the reliability of a protocol characterizing intersegmental hyper-resistance to passive stretch|"Passive solicitations of the main joints of the lower limb, of healthy children and children with cerebral palsy, are realized by two evaluators with a handheld dynamometer.
~Repeated measures are performed to assess intra and inter-reliability."
15782040|NCT04596839|Drug|Remdesivir|Remdesivir INN 100 mg lyophilized powder for infusion
15782041|NCT04596839|Other|Standard of Care|Standard of Care Treatment for COVID-19 Infection
15782042|NCT04596826|Drug|Dronabinol 5 MG|oral administration
15782043|NCT04596826|Drug|Dronabinol 10 MG|oral administration
15782044|NCT04596826|Drug|Placebo|oral administration
15782045|NCT04596813|Device|CytoSorb 300 mL device|Intra-and postoperative CytoSorb hemoadsorption
15782046|NCT04596800|Other|Prehabilitation Program + Enhanced Recovery After Surgery|Prehabilitation Program (nutrition + exercise + psychological counseling) + ERAS protocol
15782047|NCT04596800|Other|Enhanced Recovery After Surgery|ERAS
15782048|NCT04596787|Procedure|Bilateral Thoracic paravertebral block|The blocks were performed at the T3-T4 level bilaterally to block the dermatomes between the T2 and T6 levels (breast innervation area).
15782049|NCT04596774|Procedure|Traditional Approach|Patients received intraoperative 10 mL/kg/h IV izolen infusion. Opioids and PONV prophylaxis were applied when required.
15782050|NCT04596774|Procedure|Enhanced Recovery After Surgery (ERAS) Approach|Patients did not preoperatively smoke for 48 hours, drank clear liquids until the last 2 hours and received 6 mL/kg/h IV izolen infusion intraoperatively. In these; gastric aspiration was applied before extubation, PONV prophylaxis was supported routinely, and patient controlled analgesia was added to the routine analgesia plan for the first postoperative 48 hours.
15782051|NCT04596761|Device|RF-utilizing powered toothbrush|RF-utilizing Powered toothbrush
15782052|NCT04596761|Device|Control placebo with no RF|Placebo control, toothbrush with no RF
15782053|NCT04596748|Dietary Supplement|Probiotic|Bacillus Subtilis, Bacillus Clausii, Bacillus Coagulans, Bacillus Indicus HU36, MCC 102
15782054|NCT04596748|Dietary Supplement|Placebo|Placebo caps
15782055|NCT04596722|Dietary Supplement|Pomella|"Pomella® Pomegranate Whole Fruit Extract containing 75 mg punicalagin in white/white HPMC size 1 capsules packed in white color HDPE bottle of 30 counts"
15782056|NCT04596722|Other|Placebo|"White/white HPMC size 1 capsules each containing 97.67% Maltodextrin, 0.10% Tartrazine color, 0.22% Brown Color, 2.01% Aerosil packed in white color HDPE bottle of 30 counts"
15782057|NCT04596709|Dietary Supplement|Vitalose|dissolved in water
15782058|NCT04596709|Dietary Supplement|isomaltulose|dissolved in water
15782059|NCT04596709|Dietary Supplement|sucrose|dissolved in water
15782060|NCT04596709|Dietary Supplement|glucose|dissolved in water
15782061|NCT04596696|Biological|Rotavac|Rotavac Is a monovalent vaccine containing suspension of live attenuated rotavirus 116E strain, a naturally occurring reassortant strain G9P[11], containing one bovine rotavirus gene P[11] and 10 human rotavirus genes prepared in Vero cells administered orally at 6, 10 and 14 weeks of age.
15782062|NCT04596683|Procedure|Same-day NSM or SSM|Discharge home same-day after nipple-sparing mastectomy (NSM), or skin-sparing mastectomy (SSM)
15782063|NCT04596670|Drug|68Ga-ICAM-1pep|68Ga-ICAM-1pep PET/CT: after intravenous injection of 2.96 MBq/kg body weight of quality-controlled 68Ga-ICAM-1pep, a Siemens Biograph PET/CT scan will be applied within 1 h, and the scan range will be from the top of the head to 1/3 of the upper thigh.
15782064|NCT04596657|Dietary Supplement|Vitamin D supplementation|Daily vitamin D3 supplementation (5000 IU)
15782065|NCT04596644|Drug|Cannabis|Investigates two strengths of cannabis.
15782068|NCT04596618|Device|Forearm cooling|forearm cooling will be performed for active cooling assessment.
15782069|NCT04596605|Other|T2309|Food for Special Medical Purpose / 4 capsules daily for 12 weeks
15782070|NCT04596605|Dietary Supplement|Nutrof Total|2 capsules daily for 12 weeks
15782074|NCT04596566|Other|Therapeutic diet Intervention|The CD-TDI will incorporate global principles of the Mediterranean Diet (MD) refined to inform specific food choices based on our pilot data results and published literature reported mechanisms of mitigating inflammation in IBD. Patient compliance will be measured in three ways: 1) Mediterranean diet score checklists completed every 3 weeks at the face-to-face visits; 2) goal attainment scores captured weekly to identify the goals set, and the goals attained 47; and 3) fatty acids profiled from red blood cells to identify if fat intake reflects CD-TDI fat recommendations: 35% total calories from fat, 15% from MUFA, 13% from SFA and 6% from PUFA with a 8 n6:n:3 ratio of 8:1
15782075|NCT04596553|Dietary Supplement|Essential Amino Acid|Immediately following the exercise intervention participants will consume their assigned essential amino acid supplement
15782076|NCT04596553|Dietary Supplement|Collagen Peptide|Immediately following the exercise intervention participants will consume their assigned collagen peptide supplement
15782077|NCT04596553|Dietary Supplement|Maltodextrin Placebo|Immediately following the exercise intervention participants will consume their assigned maltodextrin supplement
15782078|NCT04596540|Drug|SEL-212A|"SEL-212A Drug: SEL-037 (0.2 mg/kg) SEL-037, PEGylated uric acid specific enzyme (uricase) Other Names: Pegadricase, pegsiticase
~Drug: SEL-110.36 (0.1 mg/kg) Other Names: SEL-110, ImmTOR"
15782079|NCT04596540|Drug|SEL-212B|"SEL-212B Drug: SEL-037 (0.2 mg/kg) SEL-037, PEGylated uric acid specific enzyme (uricase) Other Names: Pegadricase, pegsiticase
~Drug: SEL-110.36 (0.15 mg/kg) Other Names: SEL-110, ImmTOR"
15782080|NCT04596540|Other|Placebo|Normal saline
15782081|NCT04596527|Drug|18F-FMPP|18F-FMPP were injected into the patients at rest (2.5 mCi) and during stress (6.0 mCi) for an individual subject before PET/CT scans.
15782082|NCT04596514|Procedure|REBOA|Resuscitative endovascular balloon occlusion of the aorta (REBOA)
15782083|NCT04596514|Procedure|usual procedure according to guidelines|Treatment as described in the guidelines from the European Resuscitation Council, the Norwegian Resuscitation Council, and other local national guidelines
15782085|NCT04596488|Drug|Efavirenz 400mg|HIV-infected patients were treated with efavirenz 400mg combined with tenofovir 300mg and lamivudine 300mg.
15782086|NCT04596475|Drug|glecaprevir/pibrentasvir (GLE/PIB)|The study intervention consists of a single daily dose of GLE/PIB 100/40 mg (one dose consists of 3 tablets) administered orally; or crushed and administered via a feeding tube if participant is unable to swallow by mouth, for example in the immediate post-operative period. First dose will be administered in the pre-operative period within 4 hours of surgery followed by once daily doses for 7 days total.
15782087|NCT04596462|Drug|68Ga-FAPI|Intravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-FAPI. Tracer doses of 68Ga-FAPI will be used to image lesions of SAPHO by PET/CT.
15782088|NCT04596449|Other|study intervention|"The sleep structure of healthy volunteers will be recorded (9 Electroencephalograms (EEG), 2 Electrooculograms (EOG), 2 Electromyograms (EMG) and 2 Electrocardiograms (ECG)) during 1 night. The characteristics of the spindle (density, frequency and amplitude) will be automatically analyzed from purified EEG during Non Rapid Eye Movement sleep (NREM).
~Volunteers will completed a neuropsychological evaluation that will evaluate Sustained attention (simple reaction time test), Vigilance (TAP Vigilance), Sustained and selective attention (CPT II), Inhibition (Stroop test), Mental flexibility (TAP flexibility) , Executive operation (Tower of London), Short-term memory (Wechsler code test).
~Driving performance will be analyzed as part of a complex scenario involving attentional and high-level functions on a driving simulator."
15782089|NCT04596436|Other|no intervention|no intervention
15782090|NCT04596423|Diagnostic Test|Fetal echocardiography|fetal heart examination by medical ultrasound
15782091|NCT04596410|Radiation|LLLT applied every other day|Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied every other day
15782092|NCT04596410|Radiation|LLLT applied daily|Low-level laser therapy (LLLT) protocol combining red and infrared wavelengths applied daily
15782093|NCT04596397|Other|Inpatient setting|These women stay at the hospital.
15782094|NCT04596397|Other|Outpatient setting|These women can leave the hospital.
15782095|NCT04596384|Other|Best Practice|Participate in a surgeon-only perioperative care program
15782096|NCT04596384|Procedure|Functional Assessment|Complete a functional assessment
15782097|NCT04596384|Other|Medical Device Usage and Evaluation|Wear an actigraph
15782098|NCT04596384|Procedure|Nutritional Assessment|Complete a nutritional assessment
15782099|NCT04596384|Other|Quality-of-Life Assessment|Ancillary studies
15782100|NCT04596384|Other|Questionnaire Administration|Ancillary studies
15782101|NCT04596384|Other|TapCloud|Use TapCloud app
15782102|NCT04596371|Other|pure pulmonary ground glass nodules in women preparing for pregnancy|pure pulmonary ground glass nodules in women preparing for pregnancy
15782103|NCT04596358|Other|Observational|Evaluation of adherence to the Mediterranean diet through the administration of the Med Diet Score questionnaire.
15782104|NCT04596332|Other|no intervention measures|Because this study was a retrospective study, no intervention measures were implemented for the patients enrolled.
15782105|NCT04596319|Biological|AP-PA02|Bacteriophage administered via inhalation
15782106|NCT04596319|Other|Placebo|Inactive Placebo administered via inhalation
15782107|NCT04596306|Procedure|Laparoscopic Cholecystectomy|Laparoscopic Cholecystectomy
15782108|NCT04596293|Drug|BBT-401-1S|BBT-401-1S 8 weeks + Extension phase 8 weeks
15782109|NCT04596293|Drug|Placebo|Placebo 8 weeks + Extension phase 8 weeks
15782110|NCT04596280|Procedure|Colonic Resection|Resection of the colonic tract which has been interested by the acute diverticulitis
15782113|NCT04596254|Other|Pomegranate Juice|Collection of Mother's milk before and after juice consumption
15782114|NCT04596241|Device|BTL-899|Treatment with intensities of a magnetic field and radiofrequency energy just below the patient's tolerance threshold.
15782115|NCT04596228|Device|BTL-899|Treatment with intensities of a magnetic field and radiofrequency energy just below the patient's tolerance threshold.
15782119|NCT04596189|Drug|Dupilumab 300 MG in 2 ML Prefilled Syringe|"The Dupilumab will be administered following clinic procedures and blood collection. Patients will be monitored at the study site for at least 30 minutes after injections for signs of hypersensitivity reaction.
~Subcutaneous injection sites should be alternated among the 4 quadrants of the abdomen (avoiding navel and waist areas), the upper thighs or the upper arms, so that the same site is not injected twice consecutively. Injection in the upper arms could be done only by a trained person (caregiver trained by Investigator or Delegate) or health care professional but not the patients themselves."
15782120|NCT04596189|Other|Placebo|"The Placebo will be administered following clinic procedures and blood collection. Patients will be monitored at the study site for at least 30 minutes after injections for signs of hypersensitivity reaction.
~Subcutaneous injection sites should be alternated among the 4 quadrants of the abdomen (avoiding navel and waist areas), the upper thighs or the upper arms, so that the same site is not injected twice consecutively. Injection in the upper arms could be done only by a trained person (caregiver trained by Investigator or Delegate) or health care professional but not the patients themselves."
15782121|NCT04596189|Drug|Mometasone Furoate nasal spray|On a daily basis throughout the study, the patient will use a paper diary to record daily use of mometasone furoate nasal spray (MFNS) 50 μg/actuation nasal spray, suspension (refer to the package insert & SmPC for a description, administration details and precautions for use). MFNS is provided in a bottle that contains 18 g (140 actuations) of product formulation. If patient is unable to tolerate 200 micrograms twice a day (total dose 400 micrograms) due to experiencing adverse event, patient may reduce dose to 200 micrograms once per day.
15782122|NCT04596176|Other|Program Supportive Housing Services|The existing statewide SH model that included routine access to housing (voucher) and case management
15782123|NCT04596176|Other|Intensive Supportive Housing Services|an intensive treatment SH model with a higher dosage of case management, family teaming, and access to a vocational specialist
15782124|NCT04596163|Procedure|Transversus thoracis muscle plane block|After general anaesthesia, transversus thoracis plane (TTP) block, a kind of regional block will be performed near both sides of the sternum under ultrasound guidance using either levobupivacaine or normal saline to both groups of patients. The end point for injection is the fluid spread along the plane just superficial to the transversus thoracis muscle, together with the downward displacement of the pleura.
15782127|NCT04596137|Behavioral|İnfant pain management|Kangaroo mother care was applied to the infants during heel prick. With kangaroo mother care, the pain of infants was reduced.
15782128|NCT04596124|Device|fitostimoline plus|randomized controlled multicentric study
15782129|NCT04596098|Other|Blood sampling|During a care-related blood sampling, patient will provide additional blood sample for research purpuse.
15782130|NCT04596085|Dietary Supplement|Investigational Product - ViraCide|Viracide
15782131|NCT04596085|Other|Placebo - Starch Powder Soft gels|Starch Powder Soft gels
15782132|NCT04596072|Combination Product|Chinese traditional rehabilitation|Chinese traditional rehabilitation including acupuncture and herbs
15782133|NCT04596059|Other|Frisolac Gold Intensive HA|Regular medical care
15782134|NCT04596046|Procedure|steroid injecting|Group L: Triamcinolone acetonide was administered to the patients through injecting inside the lesion.Group S: Oral methylprednisolone was administered to the patients.
15782139|NCT04596020|Other|Blood Flow Restriction Group (exercise with blood flow restriction using a Delfi unit)|Each group performs the same 4 exercises The BFR group will utilize the Delfi BFR unit
15782140|NCT04596007|Drug|HEC83518 tablets|Each dose of HEC83518 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.
15782141|NCT04596007|Drug|Placebo|placebo
15782142|NCT04595994|Drug|Selinexor|For both interventional ( Selinexor and Gencitabine) Dose-limiting toxicity (DLT) will be applied only to either of the following toxicities occurring during the first treatment cycle (days 1-21).
15782143|NCT04595981|Drug|Cisplatin|Subjects will be admitted to the UAB Heart and Vascular Center, pre-medicated with 24 mg Ondansetron IV, 500 mg Prednisolone IV and 1.5 L NaCl with 20 meq KCl IV. The chemo-embolic agent is prepared in the HVC pharmacy by reconstituting 300 mg lyophilized Cisplatin in 60 mL 0.9% NaCl. Subjects are placed under anesthesia in the angiography suite. The access site is prepped and draped in sterile fashion then the femoral artery is catheterized using a 5-French catheter containing a coaxial microcatheter. After superselective visualization of the tumor-feeding vessel, a microcatheter is advanced into the target vessel and infused with 150 mg m2 cisplatin in 45-60 mL NaCl over 30-60 seconds. 10 seconds after the infusion starts, 9 gm sodium thiosulphate is administered IV to neutralize systemic Cisplatin. A post-infusion angiogram is then performed to assess the adequacy of embolization. The catheter is removed and the arteriotomy site closed with a subcutaneous suture.
15782144|NCT04595968|Device|Vestal DM Active device|Battery powered non-invasive neurostimulation device
15782145|NCT04595968|Behavioral|Lifestyle modification|Subjects are prescribed a low calorie (500kcal deficit) diet if their BMI is ≥25. If a subject has a BMI of ≤24.9, they will be provided with guidance on ensuring their recommended daily dietary intake is achieved throughout the course of the trial (i.e 2,500kcal/day for men and 2,000kcal/day for women)
15782146|NCT04595968|Device|Vestal DM Sham device|Placebo comparator sham device (no active stimulation)
15782147|NCT04595955|Other|CMyLife|CMyLife is a digital patient platform for Patients With Chronic Myeloid Leukemia.
15782148|NCT04595942|Drug|Midodrine Hydrochloride Tablets|Patients will be started on 5 mg Midodrine three times a day and after one week the dosage will be up-titrated to 10 mg three times a day and continued for 12 months. They will receive the medication at four-hour intervals upon rising in the morning (the last dose should not be taken later than 6 PM). In case of intolerance, the dosage will be reduced to 2.5 mg three times a day. Patients will also receive recommendations for lifestyle modifications including drinking 2 to 3 liters of fluid per day, daily consumption of 10 grams of salt, and practicing counter-pressure maneuvers (handgrip, arm-tensing, leg crossing and squatting).
15782149|NCT04595942|Drug|Fludrocortisone Acetate Tablets|Patients will be started on 0.05 mg of fludrocortisone twice daily and after one week the dosage will be up-titrated to 0.1 mg fludrocortisone twice daily taken for 12 months. Patients will also receive recommendations for lifestyle modifications including drinking 2 to 3 liters of fluid per day, daily consumption of 10 grams of salt, and practicing counter-pressure maneuvers (handgrip, arm-tensing, leg crossing and squatting). In this arm, potassium levels will be checked 7-14 days after dose stabilization.
15782150|NCT04595942|Behavioral|Lifestyle modification|Patients will be recommended to drink 2 to 3 liters of fluid per day, consume 10 grams of salt per day, and practice counter-pressure maneuvers (handgrip, arm-tensing, leg crossing and squatting) for 12 months.
15782151|NCT04595929|Procedure|Staging laparoscopy|All patients undergo staging laparoscopy and peritoneal lavage.
15782152|NCT04595929|Drug|5-Fluorouracil|Day 1 q2w: 2600 mg/m² IV over 24 hours
15782153|NCT04595929|Drug|Leucovorin|Day 1 q2w: 200 mg/m² IV over 30 minutes
15782154|NCT04595929|Drug|Oxaliplatin|Day 1 q2w: 85 mg/m² IV over 2 hours
15782155|NCT04595929|Drug|Docetaxel|Day 1 q2w: 50 mg/m² IV over 1 hour
15782156|NCT04595929|Procedure|Radical surgery|Radical gastrectomy with D2 - lymph node dissection.
15782157|NCT04595929|Procedure|PIPAC|Intraoperative Pressured Intraperitoneal Aerosol Chemotherapy (PIPAC) with cisplatin 7,5 mg/m², doxorubicin 1,5 mg/m².
15782158|NCT04595929|Drug|Adjuvant chemotherapy|Adjuvant chemotherapy according to indications.
15782159|NCT04595916|Drug|Polyene phosphatidylcholine injection 930 mg QD|Polyene phosphatidylcholine injection 930mg, diluted with 5% glucose solution 250ml, once a day, at least 2 weeks but no more than 4 weeks.
15782160|NCT04595916|Drug|Magnesium Isoglycyrrhizinate injection 200 mg QD|Magnesium isoglycyrrhizinate injection 200mg, diluted with 5% glucose solution 250ml, once a day, at least 2 weeks but no more than 4 weeks.
15782161|NCT04595903|Device|Hemopurifier|Hemopurifier treatments will be one four to six hour treatment session daily for up to 4 days
15782162|NCT04595890|Biological|Autologous Nucleated Cells|For each participant, bone marrow will be aspirated from the iliac crest, and then processed to achieve a concentrated dose of autologous, nucleated cells. These cells will be injected into the same participant's knee that is affected by knee OA.
15782163|NCT04595877|Drug|Dipyrone administration|Dipyrone 2 g (Nolotil®, Europharma, Madrid, Spain); one ampoule in 50 mL of 0.9% saline solution as an intravenous infusion over 10 min.
15782164|NCT04595877|Behavioral|Pain assessment|"Pain will be evaluated by the patient according to a 100-mm visual analogue scale (VAS) (from point 0 no pain to point 10 unbearable pain)."
15782165|NCT04595877|Biological|beta-endorphin immunoreactivity|Plasma beta-EPIr levels will be measured by an immunoradiometric assay (Allegro Beta-endorphin, Nichols Institute Diagnostics, SAN JUAN DE CAPISTRANO, CA) (normal values 29-40 pg/mL). It will be obtained by venous blood samples (5 mL) at the same time points at pain will be measured.
15782166|NCT04595877|Other|Placebo administration|Placebo in 50 mL of 0.9% saline solution as an intravenous infusion over 10 min.
15782167|NCT04595864|Other|Transarterial chemoinfusion (TAI) with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)|TAI
15782168|NCT04595851|Other|Patient Reported Outcome Measure (PROM)|Participants will complete a PROM (Michigan Oncology Quality Consortium, Patient Assessment Tool for Oral Chemotherapy) for their oral anticancer agent (OAA) at two timepoints over 2 months, to assess patient symptoms and adherence to OAA.
15782169|NCT04595851|Other|Comprehensive Medication Review (CMR)|Following the first PROM, participants will be contacted by the primary care pharmacist for a Comprehensive Medication Review (CMR) for their chronic medications. If warranted, a follow-up CMR will take place after the second PROM.
15782464|NCT04593329|Other|TIRADENTES ASSOCIATION PLACEBO|Tiradentes association placebo tablet
15782170|NCT04595851|Other|Communications between oncology and primary care pharmacists|Throughout the study, the oncology and primary care pharmacists will communicate about medications through the electronic medical record.
15782171|NCT04595838|Device|Chemo Mouthpiece|Frozen tube that fills the oral cavity used during and after chemotherapy to ease and prevent symptoms of oral mucositis
15782172|NCT04595838|Other|Best Supportive Care only|Standard Oral care for Chemotherapy
15782173|NCT04595825|Biological|CM-101|CM-101, Monoclonal Ab blocking CCL24
15782174|NCT04595825|Other|Placebo|Placebo
15782175|NCT04595812|Drug|Misoprostol 200mcg Tab vaginal|2 tablets vaginally 1 hour before surgery
15782176|NCT04595812|Drug|Oxytocin|30 IU oxytocin in 500 ml normal saline at a rate of 120 ml/h
15782177|NCT04595812|Drug|Carbetocin|100 μg IV Carbetocin (1ml) in 5 ml saline over 1 minute
15782178|NCT04595812|Procedure|pericervical hemostatic tourniquet|a Foley catheter size 18, which will be firmly tied at the level of the cervico-isthmic junction of the uterus before the uterine incision,The time of tourniquet administration will be recorded, and will be released not later than 45 minutes after its application. For those requiring multiple applications, the tourniquet will be reapplied after a period of at least 15 minutes.
15782184|NCT04595734|Other|No intervention due to observational methods of study|No intervention due to observational methods of study
15782185|NCT04595721|Behavioral|Hidden object|Participant will be instructed to look at the hidden object image on the overhead light to look for a number of objects and observe the image.
15782186|NCT04595721|Behavioral|Stress ball|Participants will be handed a single-use, squeezable stress ball and instructed to squeeze the stress ball.
15782187|NCT04595708|Behavioral|Phone Call|Calls were made by volunteers trained to engage with participants. Call structure was unscripted and call length was recommended to be between 5-10 min.
15782188|NCT04595695|Behavioral|Transparent mask|A transparent mask worn by the surgeons in customary fashion will be used.
15782189|NCT04595695|Behavioral|Typical surgical covered mask|A standard covered surgical mask worn by the surgeons in in customary fashion will be used.
15782190|NCT04595682|Drug|Placebo|Participants will attend two identical laboratory sessions to test sensitivity to the rewarding and disinhibiting effects of a controlled dose of alcohol, once during the early follicular phase and once during the late follicular phase. The test battery consists of measures of rewarding effects and alcohol (or placebo) effects on disinhibition and impulsive choice. The placebo consists of 300 ml of lemon-flavored soda with a small amount (3 ml) of alcohol floated on top.
15782191|NCT04595682|Drug|Alcohol|Participants will attend two identical laboratory sessions to test sensitivity to the rewarding and disinhibiting effects of a controlled dose of alcohol, once during the early follicular phase and once during the late follicular phase. The test battery consists of measures of rewarding effects and alcohol effects on disinhibition and impulsive choice. The alcohol dose consists of 0.60 g/kg absolute alcohol that produces a peak blood-alcohol concentration of 80 mg/dl. Doses will be mixed with a carbonated, non-caffeinated, lemon-flavored soda and consumed within 10 minutes.
15782192|NCT04595669|Behavioral|Personalised advise|personalised dietary advice in combination with feedback on dietary behaviour and health status (i.e. waist circumference, blood pressure, cholesterol, glucose and triglycerides)
15782193|NCT04595656|Other|verbal autopsy interview|The study involves filling of verbal autopsies for deaths in SEACTN villages. This is an observational study being conducted as a substudy of rural febrile project of SEACTN program.
15782194|NCT04595643|Other|Combination of different dysphagia training modalities|Neuromuscular electrical stimulation, Masako exercises, Mendelsohn maneuver, chin down, mobilization, shaker exercises, eating different food consistencies.
15782195|NCT04595630|Other|data collection from the hospital records|The clinical data from the patients enrolled in the study, such as the medical history, functional state, and EuroSCORE, and the hematological, basic renal, hepatic, and metabolic chemistry findings (including cTn as defined per the protocol), the operative data (operating time, blood loss, cardiopulmonary and cross-clamp time, number of arterial and venous grafts, the number of distal anastomoses, flow measured at all bypass grafts at the end of the intervention and the need for an assist device) and CCT scan data (at discharge from hospital facility) will be obtained from the hospital records. The data will be entered into a database.
15782196|NCT04595617|Biological|Antibodies screening|All included GT patients will be enrolled from different national centres during a 6 months period. Antibodies screening will be systematically realized every six months (+/- 2 weeks) and after each last blood transfusion at 7-10 days and one month (+/- 2 weeks), during a period of 18 months.
15782197|NCT04595604|Procedure|Trimodal rehabilitation + ERAS|Prehabilitation will cover a range preoperative education and exercises (weekly) on diet, physical activity (daily walking), respiratory training (forced deep inspiration with spirometer device), as well as anxiolytic group psychotherapy.
15782198|NCT04595604|Procedure|ERAS + nutritional prehabilitation|Enhanced Recovery Program, including preoperative 4 weeks nutritional supplementation.
15782199|NCT04595591|Drug|2mg/kg/min|titration dosing speeds of propofol at 2mg/kg/min
15782200|NCT04595591|Drug|1mg/kg/min|titration dosing speeds of propofol at 1mg/kg/min
15782201|NCT04595591|Drug|0.5mg/kg/min|titration dosing speeds of propofol at 0.5mg/kg/min
15782310|NCT04594694|Drug|Bezafibrate 400 MG|400 mg SR tablet of Bezafibrate once daily for the remainder of the study
15782311|NCT04594694|Drug|Bezafibrate 400 mg Placebo|One tablet daily for the remainder of the study
15782312|NCT04594681|Drug|Placebo|Placebo is administered once daily or three times daily.
15782202|NCT04595578|Device|Cerebellar repetitive transcranial magnetic stimulation|rTMS was delivered on the scalp for over 2 cm under the inion, which is the scalp over the cerebellum area, using a double-cone coil connected to a Magstim Rapid2® stimulator with two Booster Modules (Magstim, Spring Gardens, Wales, UK) in accordance with safety recommendations. Stimulation was delivered to the cerebellum at 10 Hz with 90% of the mean resting motor threshold intensity for 5 seconds at 55 second intervals to deliver 1000 pulses in 20 minutes. Immediately after rTMS, the combination treatment group received balance and gait training by a physical therapist for 30 minutes/day and underwent aerobic exercise using a stationary bicycle at moderate intensity (12 to 14 rating of perceived exertion) for 30 minutes/day and 5 days/week for two weeks. In the control group, no participants received physical therapy or rTMS for two weeks.
15782203|NCT04595565|Drug|Capecitabine|2000 mg/m² day 1-14 q21 day cycle for eight cycles
15782204|NCT04595565|Drug|Carboplatin|AUC 5 q3w or AUC 1.5 weekly for eight 3 weekly cycles
15782205|NCT04595565|Drug|Cisplatin|25mg/m3 weekly or 75 mg/m3 q3w
15782206|NCT04595565|Drug|Sacituzumab govitecan|10 mg/kg body weight on days 1, 8 q3w
15782207|NCT04595552|Other|language therapy|auditory training and language therapy for 6 months up to 2 years in 2 session per week the duration of session 30 minuets
15782208|NCT04595539|Behavioral|Behavioral Activation treatment with Attention Training Technique|"The BATD includes the development of a shared formulation, psychoeducation, self-monitoring of daily activities, identifying depressed behaviours, developing alternative goal orientated behaviours, scheduling of valued activities, and problem solving around difficulties implementing scheduled activities.
~Wells's Attention Training is a task designed to train selective attention to specific information by training individuals to attend to multiple auditory external sources. In addition to auditory exercices, the ATT sessions included psychoeducation, discussion around rumination (e.g. controllability, usefulness), self-report evaluation of self-focused before and after the auditory exercices, and transfer to everyday life."
15782209|NCT04595526|Procedure|Forced expiratory technique and induced sputum|The intervention is based on the patient's own attempt to deliver a sputum sample after instructions of proper huff forced exhalation and coughing technique. After an attempt to deliver a sputum sample the patient will receive a 0,9% isotonic saline by an inhalation mask to induce the sputum, thereafter the patient will again make an effort to expectorate a sputum sample repeating the forced expiratory technique.
15782210|NCT04595526|Procedure|Tracheal suction|Tracheal suction is often used on intubated patients at the intensive care unit to collect sputum, and this method has become the standard procedure at several emergency departments.
15782211|NCT04595513|Drug|TAVT-18 (sirolimus)|The investigational drug product to be used in this study is TAVT-18, a proprietary formulation of sirolimus in clinical development, by Tavanta Therapeutics, Inc. It is provided in a powder formulation in pre-measured vials.
15782212|NCT04595513|Drug|Placebo|Matching placebo
15782213|NCT04595487|Procedure|Left ventricular septal pacing|"In the LVSP group, instead of placing the standard RV lead, the commercially available 3830 Select Secure (Medtronic, Minneapolis, USA) lead is introduced via standard transvenous approach and positioned against the right ventricular side of the IVS by using the commercially available non-deflectable septal delivery sheath (C315, Medtronic, Minneapolis, USA) under fluoroscopic guidance. Subsequently this pacing lead is advanced/screwed through the interventricular septum until the left ventricular septum is reached. Accurate lead position at the left ventricular septum will be determined anatomically using fluoroscopy, and electrically by evaluating local electrograms and changes in paced electrocardiogram morphology.
~In case of unsuccessful lead positioning in the left ventricular septum, the Select Secure lead may be placed at the His bundle region (natural conduction system of the heart) or in the right ventricle according to the physician's discretion."
15782214|NCT04595487|Procedure|Right ventricular pacing|In the RVP group, the ventricular pacing lead is positioned in the right ventricle.
15782215|NCT04595474|Device|Transient Elastography|Transient elastography is a noninvasive imaging modality used to assess NAFLD and advanced fibrosis
15782216|NCT04595461|Other|Video Education|Patients receive four short YouTube videos explaining chronic rhinosinusitis and endoscopic sinus surgery
15782217|NCT04595461|Other|Control|Standard patient education with verbal and written education
15782218|NCT04595435|Procedure|Lumpectomy|Removal of lump/tumor from breast utilizing an approach that saves as much breast as possible.
15782219|NCT04595435|Radiation|Intraoperative Radiation Therapy|Delivery of low energy radiation therapy directly at surgical site, immediately removal of lump and tissue prior to final surgical closure
15782220|NCT04595422|Other|Educational Intervention|Undergo training consisting of a 60-minute educational session
15782221|NCT04595422|Other|Educational Intervention|Receive lung cancer screening educational materials
15782222|NCT04595422|Other|Questionnaire Administration|Complete questionnaire
15782223|NCT04595422|Other|Survey Administration|Ancillary studies
15782224|NCT04595409|Drug|FYB202 (Proposed ustekinumab biosimilar)|Patients will receive 1 subcutaneous (SC) injection of FYB202 at week 0 and week 4, followed by 1 SC injection every 12 weeks thereafter for the next 3 consecutive doses.
15782225|NCT04595409|Drug|Stelara® (Ustekinumab)|Patients will receive 1 subcutaneous (SC) injection of Stelara® at week 0 and week 4, followed by 1 SC injection every 12 weeks thereafter for the next 3 consecutive doses.
15782226|NCT04595396|Procedure|Laparoscopic Gastric Bypass|The LGBP was performed using a classic Roux-en-Y procedure. Briefly, a gastric pouch of 30-50 cc was constructed with an antecolic calibrated gastro-jejunal anastomosis (mechanical anastomosis using a 2.5 mm load). The biliary and alimentary limbs measured ≈70 cm and ≈150 cm, respectively, and the jejuno-jejunal anastomosis was also performed in a latero-lateral fashion (mechanical anastomosis using a 2.5 mm load). Mesenteric defects were closed with running non-absorbable sutures and the omentum was divided in every case
15782227|NCT04595383|Device|ti.care|Electronic platform for doctor-patient communication
15782228|NCT04595370|Drug|AZD9977|Participants will receive AZD9977 as per the arms they are randomized.
15782229|NCT04595370|Drug|Dapagliflozin|Participants will receive dapagliflozin as per the arms they are randomized.
15782230|NCT04595370|Drug|Placebo|Participants will receive placebo matched to AZD9977 or dapagliflozin.
15782231|NCT04595357|Procedure|Iris shelf technique|Removal of posterior segment intraocular foreign bodies through corneal incision combined with phaco-vitrectomy
15782232|NCT04595344|Other|Listening to Pure Binaural Beats|"The patients in DCG ((binaural beat group) ) and USRG (binaural beat group) listened to binaural beats.The binaural beats were produced using a software program (Audacity®, version win. 2.3.2, 2019 Audacity Team) at frequency of 10 Hz (a tone of 200 Hz in the right ear and a tone of 210 Hz in the left ear). The binaural beats that the patients in DCG-1 and USRG-1 listened to were pure frequencies, with no background music or waves."
15782233|NCT04595344|Other|Listening to classical music|The patients in DCG (classical music group) and USRG (classical music group) listened to classical music.The classical music that those in DCG-2 and USRG-2 listened to was Mozart's 40th Symphony.
15782234|NCT04595344|Other|No audio only headphone|The patients in DCG (placebo group) and USRG (placebo group) sat in a quiet room with headphones on but no audio playing
15782235|NCT04595331|Device|Sculptra Aethestic reconsituted with 8ml Sterile Water for Injection|Sculptra Aesthetic 8ml and Lidocaine treatment of cheek wrinkles
15782236|NCT04595318|Drug|Standard clinical care and varenicline|Standard clinical care includes methadone clinic-based individual behavioral counseling at least once a month using motivational and cognitive behavioral strategies. Varenicline therapy includes a one month's supply of the medication in standard doses: 0.5 mg for 3 days, 0.5 mg twice a day for 4 days, then 1 mg twice a day for 21 days.
15782237|NCT04595318|Other|Standard clinical care|Standard clinical care includes methadone clinic-based individual behavioral counseling at least once a month using motivational and cognitive behavioral strategies
15782238|NCT04595305|Device|Cardiac resynchronization therapy by CRT-P or CRT-D implantation|Clinically indicated implantation of a CRT-P or CRT-D device as per standard of care
15782239|NCT04595292|Other|older adults, assessment|Dubousset Function Test, 3-m backwards walk test, timed up and go test,Tinnetti Balance and Gait Test, Berg BalanceTest, Functional Reach Test
15782240|NCT04595279|Behavioral|Smoking sessions|Participants undergo topography and behavioral economic sessions where they can make choices to earn cigarette puffs by pulling plungers on experimental equipment
15782241|NCT04595266|Drug|FOLFOX regimen|"Leucovorin: 400 mg / m2 IV over 15 minutes on day 1 of each cycle. Fluorouracil (5-FU): 400mg / m2 IV bolus (15 min) followed by continuous IV infusion for 46 h of 2,400 mg / m2 on day 1 of each cycle.
~Oxaliplatin 85 mg / m2 IV over 120 minutes on cycle day 1"
15782242|NCT04595266|Biological|Anti-EGFR or Bevacizumab|"In case of RAS wt colorectal cancer administer anti-EGFR together with FOLFOX6m, and in case of mutated RAS colorectal cancer administer Bevacizumab together with FOLFOX6m.
~Treatment administered following Summary of medicinal Product Characteristics (SmPC) approved indications."
15782243|NCT04595266|Drug|LIVERPEARLS-Irinotecan|Chemoembolization of Irinotecan in 100 +/- 50 micron hydrogel microspheres. Irinotecan will be loaded at a dose of 100 mg. LIFEPEARLS® is a CE marked medical device consisting of microspheres for use in chemoembolization. This device allows the continuous release of irinotecan in liver tumors causing a specific necrosis. The penetration of irinotecan into the tumor tissue is deeper thanks to the microspheres, avoiding proximal occlusion of the vessels supplying the tumor.
15782244|NCT04595253|Other|acupressure|"The acupressure involves the  Vaccaria Semen within skin-colored adhesive tape that placed on the Neiguan and Shenmen acupoints as an intervention measure. Continue to massage the acupoints with fingertips for 10 minutes, 3 times per day (8 and 12 in the morning, and 4 in the afternoon) . The adhesive tape will be retained in situ for 2 days."
15782245|NCT04595240|Diagnostic Test|semen analysis|semen analysis
15782246|NCT04595227|Device|Computerized pupillary light reflex assessment device|CPLRAD may serve as an effective screening tool for glaucomatous optic neuropathy, since they can dynamically detect abnormal pupillary responses from a novel sequence of light stimuli and functionally-shaped stimuli. CPLRAD can collect the clinical examination data and objectively measure the pupil dynamic parameters monocularly and/or binocularly as indicators from the retina and optic nerve in glaucoma patients.
15782247|NCT04595214|Other|TTTS cases are treated by intra-uterine laser for separation.|MC twin anaestemosis separatio by laser. Vasa previa and placenta accreta are treated with steroids or other protocols, Positive trisomies by NIPS undergoes CVS or amniocentesis
15782248|NCT04595201|Device|NIPT|Non-invasive pregnancy testing
15782249|NCT04595188|Other|Sulphur amino acids|"For the total sulphur amino acid requirement, there are 7 different methionine test levels (without dietary cysteine) ranging from 5 to 40 mg of methionine per kilogram body weight per day.
~For the minimum methionine requirement, there are 7 different methionine test levels (with excess dietary cysteine)."
15782250|NCT04595162|Biological|GC019F|GC019F is the CAR-T cell immunotherapy targeted CD19. The subjects will receive one single infusion of GC019F.
15782251|NCT04595149|Combination Product|Bintrafusp alfa|Bintrafusp alfa (M7824, MSB0011359C) is an innovative first-in-class, bifunctional fusion protein composed of the extracellular domain of the human transforming growth factor β receptor II (TGFβRII or TGFβ Trap) covalently linked via a flexible linker to the C-terminus of each heavy chain of an immunoglobulin G1 (IgG1) antibody blocking programmed death ligand 1 (anti-PD-L1). Bintrafusp alfa is the international nonproprietary name for M7824.
15782252|NCT04595136|Drug|Drug COVID19-0001-USR|COVID19-0001-USR by nebulization for patients with mild and/or moderate SARS- COV-2
15782253|NCT04595136|Drug|normal saline|0.9% NS via nebulization
15782254|NCT04595110|Other|Observational study|Coagulation factors, Hypercoagulation biomarkers, Endothelial, Fibrinolysis and neutrophil activation biomarkers
15782255|NCT04595097|Device|inspiratory muscle traiing|The patients are encouraged to inhale against a load to increase the inspiratory muscle strength and endurance
15782256|NCT04595084|Behavioral|Mindfulness Based Cognitive Therapy for Resilience During COVID-19 plus CHAMindWell|MBCT-R is designed to foster resilience and prevent new-onset anxiety and depression disorders or exacerbation of existing conditions. MBCT-R follows the MBCT structure of eight classes and one half-day retreat, with home practice and specific daily meditation, but is live-online and focuses on specific stressors (COVID-19, its economic and social consequences). Classes of 40-50 participants are led by 2 co-leaders. Participants have CHA MindWell Monitoring and telephone support during weeks 1-8 and then every 4 weeks afterwards for 24 weeks. Participants with severe symptoms or worsening moderate symptoms will be asked if they would like a televisit with a clinician. If monitoring with CAT-MH interviews suggests symptomatic worsening, then a CHA MindWell technician will contact the participant and check-in and offer support, including setting up a televisit with a member of a clinical member of the outpatient mental health team if needed.
15782257|NCT04595084|Behavioral|Internet Cognitive Behavioral Therapy plus CHAMindWell|MoodGYM is based on CBT and interpersonal therapy targeting depression, anxiety, stress, and general psychological distress. MoodGYM has 6 sessions with five curriculum modules and a review session that can be completed within an 8-week period. iCBT participants will also be enrolled in CHA MindWell Monitoring and Support (CHA-MW). Participants across arms will have CHA MindWell Monitoring and Technician telephone support during weeks 1-8 and then every 4 weeks afterwards for 24 weeks. Participants with severe symptoms or worsening moderate symptoms will be asked if they would like a televisit with a clinician. If there are difficulties with accessing iCBT technology or if monitoring with CAT-MH or CAT-DI/ANX-CAT interviews suggests symptomatic worsening, then a CHA MindWell technician will contact the participant and check-in and offer support, including setting up a televisit with a member of a clinical member of the outpatient mental health team if needed.
15782258|NCT04595084|Behavioral|CHAMindWell|Participants across arms will have CHA MindWell Monitoring and Technician support during weeks 1-8 and then every 4 weeks afterwards for 24 weeks. Participants across arms will have CHA MindWell Monitoring and Technician telephone support during weeks 1-8 and then every 4 weeks afterwards for 24 weeks. Participants with severe symptoms or worsening moderate symptoms will be asked if they would like a televisit with a clinician. If monitoring with CAT-MH or CAT-DI/ANX-CAT interviews suggests symptomatic worsening, then a CHA MindWell technician will contact the participant and check-in and offer support, including setting up a televisit with a member of a clinical member of the outpatient mental health team if needed.
15782259|NCT04595071|Device|Voice Activated Prosthetic Interface (VAPI) Controller|A device installed between a subjects socket quick disconnect wrist connection and multi-articulating hand which enables the use of voice as a control modality in addition to their standard two-site myoelectric control.
15782260|NCT04595058|Device|Double pigtail plastic stent through lumen-apposing metal stent|Biliary drainage guided by endoscopic ultrasound: Addition or not, of a axis-orienting plastic stent, mostly, double-pigtail stent through the lumen of a lumen-apposing metal stent
15782261|NCT04595058|Device|Lumen-apposing metal stent without double pigtail plastic stent|Endoscopic ultrasound-guided transmural biliary drainage is with lumen-apposing metal stent is a formal indication according to the instruction forms of the manufacturer.
15782262|NCT04595045|Drug|Botulinum toxin type A infiltrations|Echo-guided infiltration of botulinum toxin type A (Dysport®) in the lower limbs according to normal service practice
15782263|NCT04595032|Device|3DCRT, IMRT, VMAT, SBRT|Radiation treatment
15782264|NCT04595019|Radiation|SBRT|Stereotactic Body Radiotherapy. Ultrahypofractionated radiotherapy.
15782265|NCT04595006|Other|Cold Stimulation (CS)|Subject wear cooling vest to stay cool
15782266|NCT04595006|Other|Browning Nutraceutical (BN)|Subject will consume 2000mg of curcumin a naturally-occurring polyphenol antioxidant that is found in turmeric ginger rhizome root
15782267|NCT04595006|Other|Cold Stimulation and Browning Nutraceutical (CSBN)|Subject wear a cooling vest and consume 2000mg of curcumin
15782268|NCT04594993|Device|INFINITY™ with ADAPTIS™ Technology Total Ankle System|Total Ankle Replacement
15782269|NCT04594980|Procedure|lumbar fusion|Transforaminal Lumbar Interbody Fusion will be performed using minimally invasive approach or traditional open technique.
15782270|NCT04594967|Other|Patient-centred care home (PCMH)|New model of care defined by care provision by a team of people centered in the community that is both proactive and coordinated to improve the health and wellness of the people in that community.
15782271|NCT04594954|Dietary Supplement|Diet|A high-protein low carbohydrate diet (HPLC) diet would be prescribed to the patients. HPLC (high-protein low carbohydrate) diet would comprise of energy as 20-25 Kcal/Kg IBW/day (amounting to 700- 800 Kcal less than the usual dietary intake), Protein as 1.2-1.5 gm/Kg IBW/day i.e. 30% of the total calories as proteins, 52% of carbohydrates 18% of fats with dietary fiber as 25 g/day. The protein requirements would be met with modular high protein, low calorie supplements.
15782272|NCT04594954|Other|FMT|"Stool Administration Procedure (ILBS FMT Protocol)
~500 mL filtrates will be delivered through the UGI Endoscopy into proximal jejunum [(2 to 3 minutes per 50 ml).]
~The recipient will be kept nil per oral for at least 4 hours prior to the stool instillation.
~100 mL freshly thawed sample will be given once in 15 days for 3 doses
~Non-absorbable antibiotics will be avoided in the patient from the time of enrollment into the study and therapy initiation.
~Intravenous antibiotics will be continued as per institutional protocol in the event of active sepsis based on culture and sensitivity.
~The patient will be allowed to consume liquid diet two hours after the procedure."
15782273|NCT04594954|Other|Physical Activity|"Physical Activity:
~The exercise program would consist of brisk walking. Brisk walking is defined as the walking intensity of 60-70% of their respective age-predicted maximum heart rate (target heart rate) 27,28. Speed of 5- 6 kmph considered as a brisk walking in most of the studies preferably on a treadmill for a duration of 30-45 minutes30 or brisk walking (walking faster than normal pace, measure 5000 steps continuously by pedometer). Same amount of physical activity would be prescribed to both the groups for 5 days a week for 30 -45 min."
15782274|NCT04594941|Drug|Flurpiridaz (18F) Injection|All subjects will receive 2 IV boluses of Flurpiridaz (18F) Injection obtained either by the same manufacturing process (both HPLC or both SPE) or by 2 different manufacturing processes (1 HPLC and 1 SPE), in a large peripheral vein at rest. The subjects will be randomized 1:1:1:1 to 4 possible sequences of receiving 2 Flurpiridaz (18F) Injection. Seven subjects will receive 2 doses manufactured with the same HPLC process, 7 subjects will receive 2 doses manufactured with the same SPE process, and 2 groups of 7 subjects will receive 2 Flurpiridaz (18F) Injection doses synthesized by different manufacturing processes (1 dose by HPLC followed by 1 dose by SPE or 1 dose by SPE followed by 1 dose by HPLC).
15782275|NCT04594928|Drug|GLPG3667|GLPG3667 capsules
15782276|NCT04594928|Drug|Placebo|Matching placebo capsules
15782277|NCT04594915|Drug|Edoxaban|Edoxaban according to Package Information (Summary of Product Characteristics (SmPC)).
15782278|NCT04594902|Behavioral|Infant Behavior Program (IBP)|Infant Behavior Program (IBP) is a home-based adaptation of the Child-Directed Interaction (CDI) phase of Parent-Child Interaction Therapy (PCIT), an evidence-based intervention for early externalizing problems. Consistent with recommendations we maintained core features of CDI and addressed the unique developmental needs of infants. All IBP sessions will completed remotely.
15782313|NCT04594681|Drug|KHK4951|KHK4951 is administered once daily or three times daily.
15782371|NCT04594161|Device|Double J catheter|A Double J catheter will be placed in patients with obstructive urolithiasis
15782279|NCT04594902|Other|Enhanced Pediatric Primary Care (EPPC)|Families in EPPC will receive six one-hour home visits where they will receive information about normative developmental and health expectations for their infant. Specifically, therapists will provide education on six topics: (1) cognitive and emotional development; (2) language and social development; (3) safety; (4) feeding and nutrition; (5) sleep; and (6) fitness and activity. All EPPC sessions will completed remotely.
15782280|NCT04594889|Procedure|angioplasty|Balloon releasing a drug inflated in the target vessel
15782281|NCT04594876|Other|Flouroscopic guidance cervical epidural versus cervical facet injection|The patients are classified in two groups group P for cervical epidural and group F for facet injection. The skin will be prepared with an antiseptic solution. The midline of the selected interspace will be identified under fluroscopic guidance.
15782282|NCT04594850|Biological|Cellgram-ED|Patients will receive single injection of Cellgram-ED(mesenchymal stem cell) intracavernously.
15782283|NCT04594837|Device|Unpowered Physical Therapy Robot (Phase I/Phase II)|2 weeks (3 sessions per week, total 6 sessions, ~30-45 minutes duration each session) of over-ground gait training while wearing the unpowered robot (mass only, no robotic active assistance) on foot drop in chronic hemiparetic stroke patients. f training with the unpowered robot does not significantly improve key foot drop outcomes as hypothesized, then Phase II will consist of a two group design comparing PTR (Physical Therapy while wearing Robot group) vs. PT (Physical Therapy only). If Phase I shows that wearing the unpowered robot improves the foot drop outcomes, then Phase II will use a three group randomized study design comparing PTR, PT and UPTR (Unpowered Physical Therapy Robot) groups.
15782284|NCT04594837|Device|PTR Physical Therapy while wearing Robot group (Phase II)|Subjects receive 18 one-hour PT training sessions over 9 weeks while wearing the robot initially parameterized to individual deficit severity. Subjects perform over-ground mobility tasks of increasing challenge with robotic assist, as needed. Training is generally divided into 3 phases based on individual ability to address gait deficits, postural transitions, physical demand and environmental terrain.
15782285|NCT04594837|Other|Physical Therapy Only (Phase II)|Subjects receive 18 one-hour PT training sessions over 9 weeks. Subjects perform over-ground mobility tasks of increasing challenge with therapist assist, as needed. Training is generally divided into 3 phases based on individual ability to address gait deficits, postural transitions, physical demand and environmental terrain.
15782286|NCT04594824|Other|No Intervention|no intervention
15782287|NCT04594811|Drug|NT-I7|Administered by intramuscular (IM) injection.
15782288|NCT04594811|Drug|Nivolumab|Administered by intravenous (IV) injection.
15782289|NCT04594798|Drug|Polatuzumab vedotin|IV 1.8 mg/kg per cycle
15782290|NCT04594798|Drug|Rituximab|IV 375 mg/m2 per cycle
15782291|NCT04594798|Drug|Cyclophosphamide|IV 400 mg/m2 per cycle
15782292|NCT04594798|Drug|Doxorubicin|IV 25 mg/m2 per cycle
15782293|NCT04594798|Drug|Prednisone|PO 40 mg/m2 per cycle
15782294|NCT04594772|Drug|Folfirinox|Chemotherapy will begin with FOLFIRINOX - a standard regimen used in pancreatic cancer treatment, consisting of 5-fluorouracil (2400 mg/m2), irinotecan (180 mg/m2) and oxaliplatin (85 mg/m2). Treatment will continue for 2 cycles (4 doses), and then re-evaluation will be performed. If a decision to continue with FOLFIRINOX is made, it will be administered for another 4 cycles (8 doses).
15782295|NCT04594772|Drug|Gemcitabine|At the first planned analysis, if a switch is indicated based on prespecified criteria , gemcitabine (1000 mg/m2) and nab-paclitaxel (125 mg/m2) - another standard regimen in this setting - will be used. It will be administered for 4 cycles (12 doses).
15782296|NCT04594772|Radiation|radiation therapy|Radiation therapy may be used prior to surgery, based on findings on the final pre-operative scan per standard of care. Radiation therapy will be delivered in patients with artery and venous involvement meeting the Intergroup definition for borderline resectable disease. Radiotherapy will be delivered via a hypofractionated approach over 10 fractions and will include target volumes to the primary tumor and elective coverage of vascular structures at risk. Radiation will be delivered with concurrent chemotherapy.
15782297|NCT04594772|Procedure|Pancreatectomy|Pancreatectomy should occur within 4 to 8 weeks after the last dose of preoperative chemotherapy. Staging laparoscopy may be performed at the time of planned laparotomy but is not required. Either standard or pylorus-preserving pancreaticoduodenectomy, distal subtotal pancreatectomy, or total pancreatectomy may be performed. Surgical drains and enteral tubes (e.g. gastrostomy and/or jejunostomy tubes) may be placed at the discretion of the operating surgeon.
15782298|NCT04594759|Drug|Isotretinoin|Participants will be getting isotretinoin (1-1.5 mg/kg/week)
15782299|NCT04594746|Drug|Amiodarone Hydrochloride|Amiodarone hydrochloride 2000 mg PO to be given as a 10-capsule dose pack and ingested in a single sitting with food
15782300|NCT04594746|Drug|Placebo|Oral placebo to be given as a 10-capsule dose pack and ingested in a single sitting with food
15782301|NCT04594733|Drug|minocycline (200 mg daily) and NAC (1200 mg daily) followed by placebo|minocycline (200 mg daily) and NAC (1200 mg daily) followed by placebo
15782302|NCT04594733|Drug|Placebo followed by minocycline (200 mg daily) and NAC (1200 mg daily)|Placebo followed by minocycline (200 mg daily) and NAC (1200 mg daily)
15782303|NCT04594720|Other|Identification group|papillary thyroid cancers (n=10) and benign thyroid tumors (n=10)
15782304|NCT04594720|Other|Validation group|papillary thyroid cancers (n=45) and benign thyroid tumors (n=35)
15782305|NCT04594707|Drug|PRM-151|"Cohort A: Participants will receive three loading doses of open-label PRM-151 on days 1, 3, and 5, then one infusion every 4 weeks (Q4W). 10 mg/kg of PRM 151 will be administered by intravenous (IV) infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks.
~Cohort B: Participants previously randomized to the placebo in WA42293 will receive study medication in the three loading doses on days 1, 3 and 5 in a blinded fashion. All three doses will contain PRM-151. Participants previously randomized to the treatment arm in WA42293 will receive study medication in the three loading doses on days 1, 3 and 5 in a blinded fashion. One of the three doses will contain PRM-151, whereas two doses will contain placebo."
15782306|NCT04594694|Drug|Obeticholic acid|5 mg tablet of OCA once daily titrating up to a maximum of 10 mg OCA once daily
15782307|NCT04594694|Drug|Bezafibrate 200 MG|200 mg IR tablet of Bezafibrate once daily for the remainder of the study
15782308|NCT04594694|Drug|OCA Placebo|One tablet daily for the remainder of the study
15782309|NCT04594694|Drug|Bezafibrate 200 mg Placebo|One tablet daily for the remainder of the study
15782314|NCT04594668|Drug|Senicapoc|The intervention will consist of 50 mg enteral senicapoc administered as soon as possible after randomization and again after 24 hours
15782315|NCT04594655|Procedure|surgery|colectomy
15782316|NCT04594642|Drug|TNB-486|TNB-486 is a bispecific antibody targeting CD19 on tumor cells and CD3 on T-cells.
15782317|NCT04594629|Drug|Nitroglycerin|Patients of nitroglycerine group received nebulized nitro glycerine (a vial contains 50 mg nitroclycerine ), its starting concentration was 200 mcg/ml with nitro glycerine was delivered at 2.5-5 mcg/kg/min (5 mg, 1 mg/ml) over 10 minutes by ultrasonic nebuliser connected to the inspiratory limb of the breathing circuit
15782318|NCT04594629|Drug|PGI2|Patients of PGI2 group received nebulized PGI2 (epoprostenol), 20000 ng/ml (Flolan; Glaxo Wellcome Inc, Research Triangle Park, NC) (60 ml syringe of PGI2 with concentration 20000 ng/ml was attached to an intravenous pump which delivers a titrating rate of 8 ml/h to the nebulizer compartment (MiniHEART nebulizer; Westmed, Tucson, Ariz) fixed to the inspiratory limb of the breathing circuit or to the face mask with venturi accessory for sprinkling. The nebulizer was filled with 15 ml PGI2 with nebulized oxygen flow rate 3 litres
15782319|NCT04594616|Device|Smartphone-delivered CBT for MDD|8-week Smartphone-delivered CBT for MDD. In-person cognitive-behavioral therapy (CBT) is an empirically supported treatment for MDD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral activation, and perceptual retraining/mindfulness skills.
15782320|NCT04594603|Other|Phacoemulsification for cataract|Phacoemulsification for removal of cataract
15782321|NCT04594590|Genetic|Mutation analysis|The investigators will sequence DNA samples from the patients or their families.
15782322|NCT04594577|Device|Fluispotter|Fluispotter automated blood sampling system applied for venous blood sampling of 20 10 μL samples in a 20 hours sampling session.
15782323|NCT04594564|Procedure|Total hip arthroplasty with Delta TT cup|Total hip arthroplasty using Delta TT cup and ceramic bearings
15782324|NCT04594551|Biological|Purified vero rabies vaccine - serum free|Pharmaceutical form:freeze-dried - Route of administration: intramuscular
15782325|NCT04594551|Biological|Purified inactivated rabies vaccine|Pharmaceutical form:freeze-dried - Route of administration: intramuscular
15782326|NCT04594551|Biological|Human rabies immunoglobulins|Pharmaceutical form:liquid/solution in 2 mL vials - Route of administration: intramuscular
15782327|NCT04594525|Other|Low-Intensity Psychosocial Interventions through Telemental health|Low-Intensity Psychosocial Interventions through Telemental health (Thinking healthy): The intervention will include six sessions. Each session may last to 45 min as a max, and it will be provided through telehealth. The first session will be an introduction, while the other five sessions will be covering the period from the second pregnancy trimester to the first year of the infant's life.
15782328|NCT04594512|Other|Fresh corneal lenticule and autologous serum in advanced keratoconus using ReLex Smile surgery|A 19-year-old female patient with keratoconus and chronic hydrops cornea referred to the cornea department of our clinic with thin cornea and hydrops in chronic stage and minimal dry eye symptoms. Minimum corneal pachymetry in the right eye was 378 µm as measured by optical coherence tomography(AS-OCT-Zeiss). Atlas corneal topography showed steep K-values 82.60 ax.37 and flat K 75.15 D ax 127 with -7.45 corneal astigmatism. Her best corrected visual acuity was 0.0.5 in right eye and 1.0 in the left eye. Slit lamp examination showed intense punctate epitheliopathy (Figure 1), tear film break-up time (TBUT) was measured as 7-8 sec and Schirmer test was 10 mm in right eye, and the other eye examinations were determined normally
15782329|NCT04594486|Other|Medical treatment of acute appendicitis|All cases will be treated medically and will be followed for recurrences
15782330|NCT04594473|Behavioral|Comprehensive Oncology Rehabilitation and Exercise (CORE) Program|[see arm/group descriptions]
15782331|NCT04594460|Device|Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03|the experimental arm will receive hydrogen-oxygen mixed gas inhalation (Hydrogen-Oxygen Generator with Nebulizer, AMS-H-03, output: 3 L/min (hydrogen concentration: 66.7%, oxygen concentration: 33.3%)) ,the treatment duration will be 8 hours per day, for 12 weeks.
15782332|NCT04594460|Device|OLO-1 Medical Molecular Sieve Oxygen Generator|the control arm will receive oxygen inhalation (OLO-1 Medical Molecular Sieve Oxygen Generator, output: 3 L/min (oxygen concentration: 33.3%), Shanghai Ouliang Medical Devices Co., Ltd.)the treatment duration will be 8 hours per day, for 12 weeks.
15782333|NCT04594447|Device|Physica Kinematic Retaining knee replacement|modular knee prosthesis with a Kinematic Retaining (KR) mechanism and posterior cruciate ligament (PCL) preservation
15782334|NCT04594447|Device|Physica Cruciate Retaining knee replacement|modular knee prosthesis with posterior cruciate ligament (PCL) preservation
15782335|NCT04594434|Other|Scale SUD|Subjective Units of Distress Scale ou Subjective Units of Disturbance Scale is a scale of subjective appreciation of emotions
15782336|NCT04594434|Other|VOC scale|The VOC (Validity Of Cognition) scale is a scale of value given to cognition.
15782337|NCT04594434|Other|DES II scale|The Dissociative Experiences Scale (DES), which is translated as the Dissociative Experiences Scale, is a self-questionnaire to assess the frequency of various dissociative symptoms in the patient's daily life.
15782341|NCT04594382|Diagnostic Test|Pupillometry-Opioid treatment|"At the end of anesthesia, before extubation, pupillometry measurements will be performed on both eyes, using the tetanus mode T30 (30mA tetanic stimulation) and T60 (60mA tetanic stimulation) and the standardized pupillary pain index (PPI) mode at the pupillometer.
~Opioid administration will be given by a single dose of piritramid (0.1 mg kg -1) in case of measured PDR values of ≥12 (high analgesic sensitivity as specified by the producer) after T30 and T60 stimulation. The pupillometry measurement will be repeated once on both eyes."
15782342|NCT04594382|Diagnostic Test|Pupillometry -standardized opioid treatment|"At the end of anesthesia, before extubation, pupillometry measurements will be performed on both eyes, using the tetanus mode T30 (30mA tetanic stimulation) and T60 (60mA tetanic stimulation) and the standardized pupillary pain index (PPI) mode at the pupillometer.
~A standardized single dose of piritramid (0,1 mg kg -1) will be given intravenously, regardless of the measured values. The pupillometry measurement will be repeated once on both eyes."
15782346|NCT04594343|Drug|Disulfiram|The subject will receive 500 mg of disulfiram orally or enterally through NG tube if in mechanical ventilation once daily for 14 days
15782347|NCT04594343|Drug|Placebo|The subject will receive a matching placebo orally or enterally through NG tube if in mechanical ventilation once daily for 14 days
15782348|NCT04594330|Drug|virgin coconut oil (VCO)|15 mL of VCO twice a day for 14 days
15782349|NCT04594330|Other|placebo|15 mL of placebo twice a day for 14 days
15782350|NCT04594317|Device|low level laser therapy|buccal application of diode laser on non-contact mode
15782351|NCT04594304|Behavioral|Behavioral: Usual care plus eToolkit|A baseline e-survey will be sent to participants prior to their scheduled appointment to collect baseline alcohol/tobacco use levels as well as a series of questions evaluating precursors to behaviour change. If randomized into the intervention group, patients will be sent a link to a tailored toolkit based on their behaviours, motivation to change and other pertinent factors. Patients who identify as non-smokers and meet the low-risk drinking guideline, will complete a third screening survey for physical activity. The cumulative patient profile (CPP) status for the patient for alcohol/smoking will be automatically updated post-baseline survey, and the PCP will receive a notification via EMR about the status update. For patients identifying with risky behaviours, the PCP will receive a prompt to update the CPP for the patient and will receive a link, embedded in the EMR, to a PCP-facing toolkit that facilitates evidence-based intervention.
15782352|NCT04594291|Procedure|MRI scans|This study does not involve any intervention or new treatment. We will conduct MRI scans of the kidneys, muscles, abdomen and heart at baseline, 12 and 24 months after hospital discharge. The MRI scan will take 60-70 minutes in total.
15782353|NCT04594278|Behavioral|Mindfulness Based Intervention|A remotely delivered closed group mindfulness-based intervention using Microsoft Teams Meeting will be performed, consisting of 12-16 participants (Maximum 10 groups) and one professional with a background in mindfulness coaching . Three professionals will be coaching 2-3 groups each. The curriculum entails weekly sessions (1 hour) over a 4-week period.
15782354|NCT04594265|Dietary Supplement|KetoneAid KE4 Pro Monoester|A dietary supplement containing ketone monoester.
15782355|NCT04594265|Dietary Supplement|Science in Sport Go Enegy|Dosis isocaloric to the KetoneAid Arm
15782356|NCT04594252|Drug|ALXN1840|Administered orally as tablets.
15782361|NCT04594226|Procedure|EA combined with medication|"Primary acupoints include Ashi points, Jiaji acupoints and Xi-cleft points. Jiaji points on the ipsilateral side will be selected according to the corresponding ganglia involved by HZ. Xi-cleft points will be selected based on the distribution regions of PHN. For pain sites that mainly distributed in the gallbladder meridian, GB36 will be selected. For pain sites that mainly distributed in the stomach meridian, ST34 will be selected. For pain sites that mainly distributed in the gallbladder meridian, BL63 will be selected. For pain sites that mainly distributed in the large intestine meridian, LI7 will be selected. Supplementary acupoints will be chosen based on TCM syndrome differentiation.
~Operation: Two paired of acupoints are connected to the EA apparatus. EA parameter is selected as 2/100Hz wave. EA intensity is selected according to the patients' endurance. Needles will be retained and EA will last for 30 mins for each session."
15782362|NCT04594226|Drug|Medication|The dosage of gabapentin starts from 100mg Tid. 100mg-300mg can be increased every 3-7 days and taken in three doses, but the total amount is not more than 1800mg/day. The dosage of gabapentin will be adjusted according to the patient's condition until his pain is effectively controlled. After maintaining the medication for two weeks, the dosage can be gradually reduced and 100mg can be reduced every 3-7 days.
15782365|NCT04594200|Behavioral|Audit and Feedback (A&F)|"In this protocol, we propose comparing 2 intervention design elements in a multifactorial design. Specifically, we will evaluate:
~i) an emphasis on antibiotic-associated harms in comparison to messages that focus on lack of benefit; ii) simple versus adjusted peer comparators to represent a target for the prescribing quality indicators
~We will also investigate the effects of the inclusion of materials developed by Choosing Wisely Canada (CWC) - namely the viral prescription pad - to help physicians act upon the feedback to reduce their prescribing"
15782366|NCT04594187|Other|Immunotherapy|All patients must be planned for treatment with any immunotherapy agent after sentinel lymph node biopsy (e.g. pembrolizumab or nivolumab). For patients receiving radiation therapy initiation may be before, during or after radiation.
15782367|NCT04594187|Other|Quality-of-Life Assessment|Ancillary studies
15782368|NCT04594187|Radiation|Radiation Therapy|Undergo nodal radiation therapy
15782369|NCT04594174|Procedure|Fluid administration|"Patients will be treated in accordance with the criteria of the responsible physician and the hemodynamic data obtained with the Mostcareup monitor will be recorded and used for decision-making according to the hemodynamic management protocols of each center.
~If the patient has a PPV ≥ 14%, for 3 minutes and a MAP <65 mm Hg or a Systolic Blood Pressure <90 mm Hg, a bolus volume load of 3 ml / kg weight of a balanced crystalloid solution in a time of 10 minutes36,37. The start of the volume charge (T1) will be noted by an event mark on the MostCareup monitor. The end of the volume charge (T2) will be noted by an event mark on the MostCareup monitor. Five minutes after the completion of the volume charge a new event will be marked on the MostCare monitor (T3). Both brands will serve as a reference for the analysis of hemodynamic data. Patients will be considered responders to the administration of fluids if the cardiac index (CI) increase."
15782370|NCT04594161|Device|Percutaneous Nephrostomy|A Percutaneous Nephrostomy will be placed in patients with obstructive urolithiasis
15782372|NCT04594148|Behavioral|Weight-shift training|Weight-shift training will consist of a single session of 10x 2.5min of mediolateral weight-shifting in the VR Wasp Game. Including breaks, the session will approximately take 45min.
15782373|NCT04594135|Drug|anti-CD5 CAR T cells|anti-CD5 CAR T cells transduced with a lentiviral vector to express CD5 chimeric receptor domain on T cells
15782374|NCT04594122|Behavioral|Improve hygiene practice of pork sellers|includes 5 keys actions (Handbook) and provision of equipment incentive and training on good hygiene practices, branding, and certification
15782375|NCT04594109|Behavioral|Tailored behavioral counseling|Participants in the intervention arm were provided a one-time tailored cognitive-behavioral therapy in-person cessation counseling intervention lasting approximately one hour, a 30-day supply of nicotine replacement therapy (consisting of nicotine patches and nicotine gum; dosage according to current smoking intensity according to manufacturers instructions), and a tailored bi-directional text messaging program delivering two messages per day for four weeks. The TI session was adapted from the clinical practice guidelines to include behavioral elements rooted in the minority stress model. The intervention used addressed issues of stress related to HIV stigma, minority status and socioeconomic condition.
15782376|NCT04594109|Behavioral|Standard of Care|One-time standard of care in-person behavioral counseling lasting approximately one hour, plus a 30-day supply of nicotine replacement therapy consisting of nicotine patches and nicotine gum (dosage according to current smoking intensity according to manufacturers instructions). The standard of care behavioral counseling was adapted from the current U.S. clinical practice guidelines.
15782377|NCT04594096|Behavioral|Telehealth visits|Receiving telehealth visits with a medical provider (MD or NP) 2-3 days after last chemotherapy administration in the cycle
15782378|NCT04594096|Behavioral|Standard of Care|Receiving care as usual from the UC Davis Comprehensive Cancer Center
15782379|NCT04594083|Device|Palm Stimulator|The Palm Stimulator, developed by the present researchers for the first time, is 1.6 cm in diameter, 4 cm in length, and has a cylindrical, non-slippery structure for an easy grip to ensure maximum contact with the palm The Palm Stimulator consists of blunt protrusions that will provide a tactile stimulus on the palm. The blunt protrusions do not penetrate into the skin. The simulator design is based on the gate-control theory, which allows for a reduction in the perceived amount of pain experienced during injection by closing the pain gate in the spinal cord in creating a stimulus on the skin.
15782380|NCT04594083|Device|ShotBlocker|ShotBlocker was placed in the ventrogluteal area properly 20 seconds before injection. It was fixed at the injection site until the injection process was completed.
15782381|NCT04594070|Drug|Ferrous sulfate|Iron supplementation
15782382|NCT04594057|Behavioral|Gaze and Postural Retraining Exercise|"Gaze and Postural Stability The duration and content of the Gaze and Postural Stability (GPS) intervention is specifically designed to focus on gradually increasing difficulty of gaze and postural stability exercises.
~The target duration of each in clinic visit will be 90 min (15 min of gaze stability exercises, 15 min of postural stability exercises and approximately 60 min for the standard care control intervention with rest interspersed throughout the exercise session.
~Gaze stability exercise will consist of progressive Vestibular-occular training.
~Postural stability exercises will consist of progressive static and dynamic postural training."
15782383|NCT04594044|Behavioral|tics training including habit reversal training and exposure response prevention|In an open randomized controlled study, youth were randomized to either individualized, or group treatment. Both therapies included nine sessions, and the parents were offered one group-session.
15782384|NCT04594031|Biological|ECT-001-CB (UM171-Expanded Cord Blood Transplant)|Single ECT-001-CB transplant (CD34+: 2 to 5.75x10E5/kg, CD3+ >1x10E6/kg)
15782385|NCT04594018|Drug|Finlândia Association + finasteride placebo|Finlândia association hair lotion + finasteride placebo
15782386|NCT04594018|Drug|Minoxidil + finasteride|Minoxidil hair lotion + Finasteride 1 mg
15782387|NCT04594005|Drug|abemaciclib+paclitaxel|"Phase 1b: About 6-9 patients enrollment is expected at dose level 1, -1 and 2. Dose escalation will be preceded with 3 patients/cohort until the first DLT with 4 weeks' observation. The recommend phase 2 dose (RP2D) will be defined.
~level1: abemaciclib 100mg bid, D1-28 / paclitaxel 80mg/m2, IV. D1, 8, 15 Q 4 weeks level-1: abemaciclib 50mg bid, D1-28 / paclitaxel 80mg/m2, IV. D1, 8, 15 Q 4 weeks level2: abemaciclib 150mg bid, D1-28 / paclitaxel 80mg/m2, IV. D1, 8, 15 Q 4 weeks
~Phase2: At the RP2D dose level in phase I part, we will expand phase 2 study."
15782388|NCT04593992|Device|HTEMS|high-tone external muscle stimulation
15782389|NCT04593992|Device|Placebo|Placebo stimulation
15782390|NCT04593953|Procedure|TLIP|Injection of 40 ml of ropivacaine 0.25% (2 injections of 20 ml on each side) between multifidus and longissimus muscles.
15782396|NCT04593914|Device|Cavilon Advanced Skin Protectant|"3M™ Cavilon™ Advanced Skin Protectant is a polymeric-cyanoacrylate solution intended for the protection of intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier. It is elastomeric, adhering to the contours of the skin and providing a uniform film. The film is transparent and possesses good oxygen and moisture vapor permeability.
~The polymer-cyanoacrylate is dispersed in a non-stinging solvent. The film is colorless, non-cytotoxic and has a low dermatitis potential. The film adheres to dry, moist or wet skin surfaces and remains intact during conditions of continuous or repeated exposure to moisture or caustic irritants. It will wear off the skin and does not require removal."
15782458|NCT04593368|Other|FMT|oral dosing of fecal microbiome from allogeneic donor, 0.5-2 g/kg of recipients weight
15782459|NCT04593342|Device|B-Cure Pro|The B-Cure laser Pro is a portal, non-invasive, low level laser therapy device, that emits light in the near infrared (808nm) over an area of 1X4.5 cm2 with power output of 250mW, and energy dose of 5J/min.
15782460|NCT04593342|Device|Sham|The sham device is externally identical to the B-Cure Pro and emit the same guiding light, but does not emit the therapeutic near infrared rays.
15782461|NCT04593329|Drug|TIRADENTES ASSOCIATION|Tiradentes association tablet
15782397|NCT04593901|Behavioral|Video and App Review|"Scenario Review: The scripts and/or videos will be iteratively reviewed by individual and small groups of home healthcare personnel using Zoom, Microsoft Teams, or similar. The participants will review scripts and/or recordings of the scripts and discuss how well each situation has been represented, how to improve it, and whether it is applicable in their agency.
~App Review: Following review of the scenarios, participants will review the smartphone app currently under development, including the control buttons, their placements, and other features of the screen interface. The first 9-12 participants (approximately) will be asked to provide feedback on the app's layout, control locations, and overall appearance. Once suggested changes have been made, the app will then be reviewed by the remaining participants for final review and usability assessment."
15782398|NCT04593888|Behavioral|Gluten reduced diet|Dietary advice focusing on reducing gluten intake in children
15782399|NCT04593862|Other|High-Intensity Interval Training|The intervention will be performed on a treadmill and will include a warm-up and cool-down at 50-60% and 40% of the VO2peak respectively, for up to five minutes. The HIIT protocol will be 4x4, which consists of four bouts of four minutes at a workload corresponding to vigorous intensity (75-95% of the baseline and 6-week VO2peak) alternating with three minutes of recovery intervals at 40% of the VO2peak. The exercise session will last 35 minutes and include 16 minutes of high intensity exercise.
15782400|NCT04593849|Other|Ru-Yih-Jin- Huang-Saan(RYJHS), Wan-Yin-Gao-Jia-Jean-Wey(WYGJJW), placebo ( topical agent without therapeutic effects)|We conduct a clinical trial using topical herbal medicine, including Ru-Yih-Jin- Huang-Saan(RYJHS) and Wan-Yin-Gao-Jia-Jean-Wey (WYGJJW) in treating post fracture pain and tissue swell. 24 eligible participants diagnosed of upper limb fracture with soft tissue injury grading of C1, C0 from Tscherne classification transferred from Orthopedic outpatient clinic and inpatient will be enrolled and randomly allocated to 4 groups, including experimental group A (RYJHS group), group B (WYGJJW group), placebo group( topical agent without therapeutic effects), and control group (only oral analgesics group), with 6 participants in each group.
15782401|NCT04593836|Drug|L-menthol|20ml 0.8% L-menthol spray on the pyloric ring and observe the gastric peristalsis
15782402|NCT04593836|Drug|Placebo|20ml 0.8% placebo spray on the pyloric ring and observe the gastric peristalsis
15782403|NCT04593823|Combination Product|Furoscix Infusor|Furoscix Infusor, a drug-device combination product for subcutaneous delivery of Furoscix, buffered furosemide injection, 8 mg/mL (total dose = 80 mg dose) administered subcutaneously for 5 hours.
15782404|NCT04593810|Procedure|INTELLiVENT-ASV|INTELLiVENT-ASV is activated as soon possible. The sensors for ETCO2 and SpO2 are connected and activated. Patient's gender and height are set on the ventilator and patient condition is chosen if applicable.
15782405|NCT04593810|Procedure|CONVENTIONAL VENTILATION|Conventional ventilation consists of VCV or PCV and PSV, depending on patient's activity. None of the semi or fully automated modes of ventilation is allowed at any time.
15782406|NCT04593797|Diagnostic Test|carotid blood flow measurement with ultrasound|carotid blood flow measurement with ultrasound vs transpulmonary thermodilution calibrated continuous cardiac output measurements
15782407|NCT04593784|Drug|Ciraparantag|Ciraparantag: 180 mg, intravenous
15782408|NCT04593784|Drug|Placebo|Placebo: 0.9% sodium chloride, intravenous
15782409|NCT04593784|Device|Point-of-Care Coagulometer (investigational device)|Perosphere Technologies' Point of Care (POC) Coagulometer Device will be used to measure whole blood clotting time.
15782410|NCT04593771|Drug|BCG-PPD|BCG-PPD was used for skin test in 40 healthy people, and BCG-PPD was marketed in other 40 healthy people (as control)
15782411|NCT04593758|Drug|CPI-613 + Hydroxychloroquine|dosing regimen was 2.5 mg/kg hydroxychloroquine PO followed 2 hours later by 1,000 mg/m2 of CPI-613 by central IV infusion over 2 hours followed by 2.5 mg/kg hydroxychloroquine PO 12 hours following the initial dose daily on days 1 through 5 of every 28 days.
15782413|NCT04593732|Device|STERN FIX (Sternal Stabilization System)|Sternotomy closure with STERN FIX and supplemented with wires
15782414|NCT04593719|Other|Experiment|The main components of the Lactation Management Model; breastfeeding training in the prenatal period (from the 30th week of pregnancy), early postpartum period (first 48 hours) skin to skin contact, early breastfeeding, relaxation using a dreaming technique, warm application to the breast, breast massage and for the first 48 hours after postpartum 6 months of continuous support (face to face, by phone, via social media).
15782415|NCT04593706|Drug|Betamethasone acetate + Betamethasone sodium phosphate|"the steroid will be injected to either a keloid or a 1.5 cm of the 11 cm hypertrophic scar"
15782416|NCT04593706|Drug|Dexamethasone sodium phosphate|"the steroid will be injected to either a keloid or a 1.5 cm of the 11 cm hypertrophic scar"
15782417|NCT04593706|Drug|Methylprednisolone acetate|"the steroid will be injected to either a keloid or a 1.5 cm of the 11 cm hypertrophic scar"
15782418|NCT04593706|Drug|Triamcinolone acetonide|"the steroid will be injected to either a keloid or a 1.5 cm of the 11 cm hypertrophic scar"
15782419|NCT04593693|Device|Invia Motion Endure NPWT system|lightweight portable single patient use pump, that provides continous or intermittent operation and multiple negative pressure selection options
15782421|NCT04593667|Device|hm-P bandage|hm-P bandage will be placed over the puncture site with the TR band positioned over the hemostatic bandage. The TR band will then be inflated per device specific instructions and to the group instructions. The arterial sheath will be removed from the body with slight device rotation.
15782422|NCT04593654|Drug|Dose of tinzaparin or dalteparin|The patients will be categorised into three groups depending on initial dose of thromboprophylaxis in the ICU
15782423|NCT04593641|Biological|CT-P59|administered
15782462|NCT04593329|Drug|DIPYRONE|Dipyrone 500 mg
15782424|NCT04593628|Behavioral|Connect for Caregivers|The STAR Center developed Connect for Caregivers to help improve connectedness among older caregivers of individuals with Alzheimer's Disease and Related Dementias (ADRD). Connect for Caregivers includes three components: (1) psychoeducational materials on the importance of connectedness for health and well-being; (2) a card sort-based 'discussion prioritization tool' that systematizes and routinizes the process of identifying and prioritizing barriers to connectedness; (3) personalized resources to address the identified barriers/targets. We will tailor Connect for Caregivers for Hispanic/Latino and Spanish-speaking caregivers guided by the Selective and Directed Treatment Adaptation Framework. The intervention is given once during the study.
15782425|NCT04593615|Procedure|ICG near-infrared imaging|Indocyanine green tracer is used to guide laparoscopic D2 lymph node dissection for gastric cancer
15782426|NCT04593602|Behavioral|Early Mobilization|Nurse-driven early mobilization activities twice daily
15782427|NCT04593602|Behavioral|Usual Mobility Care|Usual mobility care involves following physician orders for mobilization (i.e., bedrest, mobilization to chair with meals, physiotherapy consultation and care) as per local practice.
15782428|NCT04593589|Other|Submandibular Gland Stem Cell Transplantation|Autologous transplantation of salivary stem cells (salisphere derived cells) cultured in vitro as obtained from submandibular glands after postoperative radiotherapy
15782429|NCT04593576|Other|Physical activity protocol/out door sports|"Warm up exercise will be administered for 10 minutes, then one-to-five small group of instruction based activity will be administered for 15 minutes. After this whole group will be engaged in ball exercise and cooperative ball games for 20 minutes. At the end cool down and reward activity will be done with participants for 15v minutes.
~Total 1 hour physical activity protocol will be administered twice a week."
15782430|NCT04593576|Other|Intensive table teaching speech therapy|Control group participants will be given speech therapy session based on intensive table teaching for 30 minutes twice a week.
15782431|NCT04593563|Drug|Psilocybin|Single 5 capsule oral psilocybin dose: 25mg: 5 x 5 mg capsules.
15782432|NCT04593550|Procedure|Biospecimen Collection|Undergo collection of blood samples
15782433|NCT04593550|Behavioral|BrainCheck Cognitive Assessment|Undergo cognitive function assessment BrainCheck
15782434|NCT04593550|Procedure|Cognitive Assessment|Undergo 3D-Confusion assessment
15782435|NCT04593550|Procedure|Electroencephalography|Undergo EEG
15782436|NCT04593537|Other|No intervention|This is an observational study, no intervention is involved
15782437|NCT04593524|Dietary Supplement|vitamin D 1000 IU and A 6000 IU supplementation and nutritional counseling|24 participants, which are treatment group (I) which receives nutritional counseling, vitamin D 1000 IU, vitamin A 6000 IU
15782438|NCT04593524|Other|nutritional Counseling|control group (C) which only receives nutritional counseling for 28 days
15782439|NCT04593511|Drug|LY03009 F1|a single dose of LY03009 F1
15782440|NCT04593511|Drug|LY03009 F2|a single dose of LY03009 F2
15782441|NCT04593511|Drug|LY03009 F3|a single dose of LY03009 F3
15782442|NCT04593511|Drug|LY03009 F4|a single dose of LY03009 F4
15782443|NCT04593498|Diagnostic Test|Event loop recorder (ELR)|"Echocardiography: Comprehensive transthoracic echocardiography with special focus on left atrial dimension as well as systolic and diastolic function.
~Holter recording: standard 24h Holter recording Blood sample: 2 x 10 ml EDTA plasma sampled from venous blood at index and at 21 months"
15782444|NCT04593485|Drug|Camrelizumab for injection|Carrelizumab will be administered at a fixed dose
15782445|NCT04593472|Behavioral|Sharing Healthcare Wishes in Primary Care (SHARE)|SHARE is a multicomponent communication intervention to proactively engage family members or friends to support advance care planning in primary care.
15782446|NCT04593472|Behavioral|Minimally Enhanced Usual Care|"Minimally enhanced usual care participants are provided with print educational materials that include a 44-page brochure developed by the National Institute on Aging entitled A Guide for Older People: Talking with your Doctor and a blank easy-to-complete advance directive."
15782447|NCT04593459|Dietary Supplement|Probiotic|See Arm description
15782448|NCT04593459|Drug|Metformin Hydrochloride|See Arm description
15782449|NCT04593459|Dietary Supplement|Probiotic Placebo|See Arm description
15782450|NCT04593446|Drug|Oral Sulfate Tablet(ORA·FANGⓇ)|"Subjects who are randomized into experimental arm will receive 14 pills at 8 pm in the evening 2days before the surgery and another 14 pills on 6am in the morning 1day before the surgery
~Subjects who are randomized into comparator will receive 170ml of solution with at 8 pm in the evening 2days before the surgery and another 170ml of solution on 6am in the morning 1day before the surgery"
15782451|NCT04593446|Drug|Sodium Picosulfate Solution(PicosolutionⓇ)|Sodium Picosulfate Solution(PicosolutionⓇ)
15782452|NCT04593433|Other|Museum virtual guided tours|The intervention is a participatory art-based activity which consists in MMFA virtual guided tours. Each virtual guided tour is performed with a group of 5 participants. They meet online one time per week for a 20 to 25 min of a visit tour during a 3-month period. Each tour is different and supervised by a MMFA trained guide.
15782453|NCT04593407|Procedure|Endoscopic mucosal resection (EMR)|"Endoscopic mucosal resection (EMR) is an endoscopic resection technique that allows the removal of large colorectal lesions using a conventional lift-and-cut procedure or an underwater technique"
15782454|NCT04593407|Procedure|Endoscopic submucosal dissection (ESD)|"Endoscopic submucosal dissection (ESD) is an endoscopic procedure that allows dissection of larger colorectal lesions in one piece using endoknives.
~The procedure is technically more difficult, much more time-consuming than EMR, mandates multiday hospital admission and has an increased risk of perforation."
15782455|NCT04593394|Diagnostic Test|Continous laryngoscopy exercise test|Participants walks on a tredmill with a a flexible naso-laryngoscope in the larynx allowing visulasion of the larynx and obstructions in the larynx at the epiglottic og glottic levels are scored
15782456|NCT04593394|Diagnostic Test|Overnight respiratory polygraphy|Overnight respiratory polygraphy is a continuous recording of nasal airflow, thoracic and abdominal movements, heart rate and oxygen saturation during the night used to detected sleep apnoea
15782457|NCT04593381|Radiation|Stereotactic body radiotherapy|All patients accrued will be treated with SBRT to all sites of active metastatic disease as per CT scan or PET/CT and/or MRI. A range of schedules and doses are provided, it is advised that the maximum dose that can be achieved whilst meeting the organs at risk planning constraints is prescribed.
15782467|NCT04593316|Other|Saliva collection|A saliva sample will be collected before physical exercise.
15782468|NCT04593316|Behavioral|Questionnaires|The participant will fill in questionnaires relative to his heath status and psychological and motivational resource questionnaires before physical exercise.
15782469|NCT04593316|Other|Ingestible core temperature capsule intake|The participant will ingest a capsule before physical exercise in order to continuously monitor core temperature during physical exercise.
15782470|NCT04593316|Other|Physical exercise|The participant will perform a walk/run test.
15782471|NCT04593316|Other|Heart rate monitoring|Heart rate will be monitored during physical exercise thanks to a chest belt.
15782472|NCT04593316|Other|Core temperature monitoring|Heart rate will be monitored during physical exercise thanks to an ingestible core temperature capsule.
15782473|NCT04593303|Procedure|Internal iliac artery ligation with cervicoisthmic compression suture|Retroperitoneal approach will be performed to ligate both internal iliac arteries before bladder dissection followed by cervicoisthmic compression suture application at placental bed
15782474|NCT04593303|Procedure|Cervicoisthmic compression suture without Internal iliac artery ligation|Bladder dissection followed by cervicoisthmic compression suture application at placental bed without Internal iliac artery ligation
15782475|NCT04593290|Device|Oticon Opn S 1 miniRITE hearing aid|Everyone who participates in Part 1 (listening effort testing and cognitive testing) will be invited to participate in Part 2 (hearing aids). It is not a requirement to participate in the administration, 6-week use, and re-testing procedures involved in Part 2 of the study. All cognitively healthy participants will be invited to participate, only MCI patients with a live-in informant will be given this opportunity. After ear measurement and dome and wire length selection, Oticon Opn S 1 miniRITE hearing aid fitting will occur wirelessly using Genie software, followed by hearing aid use instructions. The fitting will use Open domes, the standard NAL-NL2 protocol, and will increase gain seven steps on top of Real Ear Unaided Gain (REUG) from 750 Hz to 6 kHz.
15782476|NCT04593277|Other|Informational Intervention|Receive printed SCP materials
15782477|NCT04593277|Other|Internet Mobile Technology|Use INSPIRE mobile application
15782478|NCT04593277|Other|Internet-Based Intervention|Access to a study-specific control website
15782479|NCT04593277|Other|Questionnaire Administration|Ancillary studies
15782480|NCT04593277|Procedure|Supportive Care|Receive telehealth stepped care
15782483|NCT04593251|Biological|CALY-002|1-hour intravenous infusion
15782484|NCT04593251|Biological|Placebo|1-hour intravenous infusion
15782485|NCT04593238|Drug|Double Antibiotic paste|Metronidazole and Ciprofloxacin
15782486|NCT04593238|Drug|Calcium Hydroxide Paste - Non-Setting|Calcium hydroxide paste to be delivered inside the canal as an intra-canal medication
15782487|NCT04593225|Behavioral|TAU + multicomponent treatment VIRTUAL SFCAMINA|Group treatment protocol of 12 weekly 60 minute virtual sessions. All sessions include the following ingredients (approx. in the same order): - Pain neuroscience education (15 min.) - Cognitive restructuring (15 min.) - Mindfulness techniques (15 min.) - Physical exercise(15 min.) - Treatment as Usual (TAU) Standard pharmacological treatment usually provided to patients with SFC.
15782488|NCT04593225|Behavioral|Treatment as Usual (TAU)|Treatment-as-Usual (TAU) consisted of the prescribed drugs adapted to the symptomatic profile of each patient and basic face to face and written advice on PNE and aerobic exercise adapted to the physical capacities of the patients at the beginning of the study.
15782489|NCT04593225|Behavioral|TAU + Physiotherapy part of VIRTUAL FIBROWALK|"Group treatment protocol of 12 weekly 60 minute virtual sessions. All sessions include the following ingredients: - Pain neuroscience education (30 min.)
~- Physical exercise(30 min.) - Treatment as Usual (TAU). Standard pharmacological treatment usually provided to patients with SFC."
15782490|NCT04593212|Diagnostic Test|Optical Coherence Tomography Angiography|Evaluation of microcirculatory dysfunction by assessment of retinal and choroidal microvasculature with optical coherence tomography angiography (OCTA)
15782491|NCT04593199|Behavioral|Gamified Smartphone App|The main objective was to evaluate whether a gamified smartphone app can improve physical activity levels and motivation to engage in physical activity in children. The gamified smartphone app, Draco, is a virtual pet simulator where you care for a pet by exercising, walking, and answering healthy lifestyle questions.
15782492|NCT04593199|Behavioral|Physical activity tracking app|Participants were asked to use the Fitbit app to track and sync their daily physical activity.
15782493|NCT04593186|Procedure|Trans-oral magnifying endoscopy with NBI|"Endoscopic procedures would be performed by endoscopists with expertise on performing magnifying NBI endoscopy. Topical local anaesthetic will be applied to the oropharynx and nasopharynx. In addition, intravenous sedation by use of Midazolam and Fentanyl would be given. Endoscopes with magnification and NBI function would be used (GF-H290Z, Olympus Medical Corporations, Tokyo, Japan). A soft black hood would be attached to the tip of the endoscope for better focal length adjustment.
~Upon insertion through a mouthpiece, the scope will then be retroflexed into the nasopharynx and the lateral walls into the Fossa of Rosenmuller and the posterior nasopharyngeal wall will be systematically examined with white light and NBI. Target suspicious areas would be examined by use of magnification with the power up to 80X. Biopsy would be taken if suspicious lesion is identified during the procedure."
15782494|NCT04593160|Drug|Diclofenac potassium- acetaminophen combination|Preoperative single dose of diclofenac potassium(50mg)- acetaminophen(1000mg) combination
15782495|NCT04593160|Drug|Diclofenac potassium|Preoperative single dose of diclofenac potassium(50mg)
15782496|NCT04593160|Drug|Placebo|Preoperative single dose of placebo
15782497|NCT04593147|Other|BBN|BBN to be fed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks.
15782498|NCT04593147|Other|Brand|Brand to be fed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks
15782533|NCT04592887|Radiation|FLASH Radiotherapy|FLASH radiotherapy is radiation treatment delivered at ultra-high dose rates compared to conventional radiation treatment.
15782534|NCT04592874|Drug|AL002|Administered via intravenous (IV) infusion
15782535|NCT04592874|Drug|Placebo|Administered via intravenous (IV) infusion
15782499|NCT04593134|Behavioral|exercise group|"exercise education: A 12-week regimen of homebased walking exercises, include moderate intensity for 40 min, three times a week.
~We explained the participants how to perform the exercises, according to an instruction manual for the exercise regimen. Participants were instructed that the exercises would be effective only if they reached 40%-60% of the heart rate reserve, as determined by the Karvonen method, or 13-14 on the RPE.
~Exercise education:
~Weekly telephone or mobile application LINE consultations concerning exercise.we discussed whether participants' exercise fulfilled the prescribed intensity, duration, frequency and whether the participants experienced any adverse effects."
15782500|NCT04593121|Drug|BIIB107|Administered as specified in the treatment arm.
15782501|NCT04593121|Drug|Placebo|Administered as specified in the treatment arm.
15782502|NCT04593108|Device|Letrozole misoprostol|Letrozole give pretreatment of abortion by misoprostol
15782503|NCT04593108|Drug|Misoprostol, placebo|Give placebo pretreatment of abortion by misoprostol
15782504|NCT04593095|Other|NeuroN-QI|SSC session lasting 2-hr during the day 4 times/wk including a 15-min of auditory stimulation with maternal voice and controlled levels of NICU light and noise followed by a 1-hr quiet period where infants will rest in their incubator/crib with olfactory stimulation and where the control of light and noise levels will be continued.
15782505|NCT04593069|Behavioral|Neurocognitive assessment|6 months after admission to the intensive care unit of Ziekenhuis Oost-Limburg, the patients will be tested on cognitive impairment
15782506|NCT04593056|Drug|Warfarin|Warfarin dispensing claim is used as the reference
15782507|NCT04593056|Drug|Rivaroxaban|Rivaroxaban dispensing claim is used as the exposure
15782508|NCT04593043|Drug|Warfarin|Warfarin dispensing claim is used as the reference
15782509|NCT04593043|Drug|Dabigatran|Dabigatran dispensing claim is used as the exposure
15782510|NCT04593030|Drug|Warfarin|Warfarin dispensing claim is used as the reference
15782511|NCT04593030|Drug|Apixaban|Apixaban dispensing claim is used as the exposure
15782512|NCT04593017|Dietary Supplement|Active Probiotic|Lactobacillus Reuteri (DSM 17938 and ATCC PTA 4659
15782513|NCT04593017|Other|Placebo Probiotic|Placebo
15782514|NCT04593004|Device|Teledermatology|Patients will be assessed and followed-up by trained physicians through a store-and-forward system (teledermatology online service - Evita® app), which allows patients to upload pictures of skin areas affected by acne as well as their symptoms or questions related to their disease.
15782515|NCT04593004|Other|Face-to-face consultation|Patients will be assessed and followed-up by trained physicians through regular face-to-face outpatient consultations.
15782516|NCT04592991|Diagnostic Test|Aortoiliac Occlusive Disease Group - PET-CT imaging with injection of 64Cu-DOTA-ECL1i|Patients from both genders, all ethnic groups, and between the ages of 45 and 75 will be considered for recruitment. We will recruit patients who have evidence of abdominal aortic aneurysm (AAA) as our study patient cohort. Patients with non-aneurysmal, atherosclerotic aortoiliac occlusive disease (n=3) will be enrolled in Aim 2A and undergo Cu-64 DOTA-ECL1i PET/CT.
15782517|NCT04592991|Diagnostic Test|AAA Group- PET-CT imaging with injection of 64Cu-DOTA-ECL1i|Patients from both genders, all ethnic groups, and between the ages of 45 and 75 will be considered for recruitment. We will recruit patients who have evidence of abdominal aortic aneurysm (AAA) as our study patient cohort. Patients with Abdominal aortic aneurysm (AAA) (n=5) will be enrolled in Aim 2B and undergo Cu-64 DOTA-ECL1i PET/CT and contrast-enhanced CT angiography between 7-14 days of their scheduled elective open repair surgery.
15782518|NCT04592978|Behavioral|Pain-Alcohol Personalized Feeback Intervention|The intervention will be designed to enhance knowledge regarding adverse pain-alcohol-opioid interrelations as well as increase motivation and intention to reduce hazardous drinking and positive attitudes and intentions regarding concurrent use of alcohol and prescription opioid medications.
15782519|NCT04592978|Behavioral|Control Personalized Feedback Intervention|The control intervention will incorporate personalized feedback relevant to exercise and nutrition but not address drinking reduction or pain-alcohol-opioid interrelations.
15782520|NCT04592965|Behavioral|Clinical and neuropsychological assessments|The assessment of disease state, clinical condition, and of cognitive and neuropsychological attributes.
15782521|NCT04592965|Behavioral|Induction of PH and associated bodily states|Assessment of subjective sensitivity to the induction of the PH and associated bodily states, for different populations of PD patients and healthy aged-matched controls
15782522|NCT04592965|Other|Resting-state fMRI acquisition|Investigation of neural mechanisms at rest, that are potentially disrupted at different degrees, for the different clinical groups of PD patients, compared to the healthy aged-matched controls
15782523|NCT04592965|Other|Induction of PH and associated bodily states (MRI)|Assessment of subjective sensitivity to the induction of the PH and associated bodily states, for different populations of PD patients and healthy aged-matched controls Assessment and comparison of the neural mechanisms responsible for the induction of the PH and associated bodily illusions, in different groups of PD patients and healthy aged-matched controls
15782524|NCT04592952|Drug|Calcitonin Gene-Related Peptide|Intravenous infusion of 1.5 µg/min of calcitonin-gene related peptide over 20 minutes.
15782525|NCT04592952|Drug|Erenumab|Erenumab 70 mg or 140 mg packed in a SureClick® Autoinjector Pen (AI)
15782526|NCT04592939|Procedure|immediate weight bearing after surgery|immediate weight bearing
15782527|NCT04592939|Procedure|6 weeks of toe-touch weight bearing after surgery|6 weeks of toe-touch weight bearing
15782528|NCT04592926|Device|Accuro SpineNav3D|The intervention will consist of a pre-procedural scan of the lumbar spine using the handheld image guidance device, Accuro, to determine spinal landmarks and anticipated depth of the intrathecal space.
15782529|NCT04592926|Other|Sham|The sham group will receive a pre-procedure sham scan (the handheld image guidance Accuro device will be placed on the back, but it will be turned off) followed by sham marking on the subject's back.
15782530|NCT04592913|Drug|Durvalumab|Human monoclonal antibody
15782531|NCT04592913|Drug|FLOT chemotherapy|A combination treatment made up of flurouroacil + leucovorin + oxaliplatin + docetaxel
15782532|NCT04592900|Other|balance exercising|selected physical therapy program strengthening the muscles of upper and lower limbs, balancing exercise, gait training in open environment,stretching for elbow flexors and forearms pronators,lower limb hip flexors and knee extensor and ankle dorsiflexors
15782536|NCT04592861|Radiation|carbon ion RT|daily carbon ion radiotherapy
15782537|NCT04592861|Drug|Chemotherapy drug|Subjects who receive carbon ion radiotherapy may receive additional chemotherapy afterwards, at the discretion of the treating physicians. Subjects on the control arm are also expected to receive chemotherapy, using a regimen selected by the treating physicians.
15782538|NCT04592848|Other|Questionnaires|"Four Questionnaires in French will be sent to participants :
~1 questionnaire about sexual and urinary symptoms before and after the surgery ;
~1 validated questionnaire Female Sexual Function Index to assess sexual function over the past 4 weeks ;
~1 validated questionnaire Body Image Scale to assess body image during the past week ;
~1 validated questionnaire Stoma Quality of Life, only for patients with incontinent urostomy.
~If the questionnaires are not returned 15 days after sending, a follow-up phone call will be made by one of the investigators.
~The data collection will include both the answers to the questionnaires and the patients' computerized medical data:
~Pathology responsible for the urological disorders and date of onset of the disorders
~Date and Type of surgery performed
~Patient's age at the time of surgery
~Post-operative complications within one month of surgery"
15782539|NCT04592835|Drug|DWRX2003|"Intramuscularly injection at predefined injection sites
~Drug: Placebo Intramuscularly injection at predefined injection sites"
15782540|NCT04592822|Drug|WD-1602|dabigatran etexilate mesylate granules for oral suspension
15782541|NCT04592822|Drug|Pradaxa®|dabigatran etexilate capsules
15782542|NCT04592809|Drug|Ketamine Hydrochloride|infused over a 40 minute period
15782543|NCT04592809|Drug|Midazolam Hydrochloride|infused over a 40 minute period
15782544|NCT04592796|Device|Xiaomi MiBand2|Recording of sleep and activity data to study their association with age.
15782545|NCT04592796|Other|Socio-demographic questionnaire|Self-made questionnaire to be administered at the beginning of the study with the following personal data: age, gender, marital status, residential environment, mobility aids, educational level, occupation, retirement type, socioeconomic status, medical records, treatment.
15782546|NCT04592796|Other|EuroQol-5D-5L|Quality of life questionnaire to be administered at the beginning and completion of the study with the following information: severity index, social value index for each health condition. Subjective evaluation of health status from 0 to 100.
15782547|NCT04592796|Other|Mini mental State Examination|Questionnaire to be administered at the beginning and completion of the study that measures cognitive impairment.
15782548|NCT04592796|Other|Tinetti Scale|Physical test to be administered at the beginning and completion of the study that measures gait and balance of the participants.
15782549|NCT04592796|Other|Barthel Index|Questionnaire to be administered at the beginning and completion that evaluates the level of independence in basic activities of life.
15782550|NCT04592796|Other|Pittsburgh Sleep Quality Assessment (PSQI)|Questionnaire to be administered whose outcome is the perceived quality, quantity and efficient of sleep. To be given at the beginning and completion of the study.
15782551|NCT04592783|Drug|Antihypertensive Agents|Antihypertensive medications will be initialed once BP is at predetermined threshold
15782552|NCT04592770|Behavioral|Nature based walk therapy|10 minutes stretching exercises followed by walk in nature for 50 minutes
15782553|NCT04592770|Behavioral|Sit in nature|Sit in nature for 60 minutes
15782554|NCT04592757|Device|Virtual mirror therapy via VR headset|Participants will perform Activities of Daily Living (ADL) in a virtual environment through a VR headset. The application is based on mirror therapy. Participants will execute certain arm movements with their non-affected arm, while seeing their affected arm perform said movement in the virtual environment.
15782555|NCT04592744|Drug|Angiotensin II|Angiotensin II infusion for Intraoperative management during liver transplantation
15782556|NCT04592744|Drug|Norepinephrine|Vasopressor infusion for management of Intraoperative hypotension in liver transplantation.
15782557|NCT04592731|Drug|Gel containing Acetylated Natural Nucleotides|The study drug is a gel containing acetylated natural nucleotides.
15782558|NCT04592731|Drug|Vehicle Gel|The vehicle gel contains no acetylated natural nucleotides but with the same base as study drug.
15782559|NCT04592718|Behavioral|Slow deep breathing plus breath counting|Participants will perform a daily 5-min slow deep breathing exercise for 4 weeks. A breathing rate of 6 breaths per minute will be targeted. In addition, participants will count their breaths during the exercise.
15782560|NCT04592718|Behavioral|Normal-paced breathing plus breath counting|Participants will perform a daily 5-min normal-paced breathing exercise for 4 weeks. A breathing rate of 15 breaths per minute will be targeted. In addition, participants will count their breaths during the exercise.
15782561|NCT04592705|Device|Therapeutic plasma exchange|"TPE is the process of plasmapheresis, an invasive procedure separating plasma from red blood cells using centrifuge-based devices.
~Filtration involves the insertion of a central venous catheter in the internal jugular, femoral or subclavian vein after which blood is drawn from the patient's circulation and transferred to a filter that separates the plasma from blood cells. Thereafter, the plasma extracted is substituted with human albumin and/or FFP."
15782563|NCT04592679|Device|FES-C|The participants were submitted to 20 sessions of FES-C three/five times per week. Each session lasted about 30'.
15782564|NCT04592679|Other|Standard Treatment|The participants were submitted to 20 sessions of standard rehabilitation for lower limbs with manual mobilization, three/five times per week. Each session lasted about 30'.
15782565|NCT04592666|Drug|Almonertinib|the standard therapy of single agent almonertinib
15782566|NCT04592666|Drug|Pemetrexed|standard dose
15782567|NCT04592666|Drug|Carboplatin|AUC=5
15782568|NCT04592653|Drug|ALKS 4230|IV infusion over 30 minutes
15782569|NCT04592653|Drug|Pembrolizumab|IV infusion over 30 minutes
15782570|NCT04592640|Other|Human amniotic mesenchymal stem cells|"Intravenous infusion of hAMSCs: once every 3 weeks, a total of 6 times (if cured before the end of the planned course of treatment, it will be terminated in advance).
~Injection of hAMSCs to local skin lesions: once every 3 weeks, a total of 6 times (if cured before the end of the planned course of treatment, it will be terminated in advance)."
15782629|NCT04592146|Other|Frailty multicomponent intervention|This intervention is based on 3 main pillars: medication review (to avoid polypharmacy), tailored nutritional recommendations and a tailored physical activity plan based on the VIVIFRAIL program.
15782630|NCT04592133|Diagnostic Test|Ultrasonography|Ultrasonography Examination
15782571|NCT04592627|Other|Simulated home environment visit|During the simulated home environment visit participants will 1) participate in a simulated University of Texas (UT) Physicians Stroke Outpatient Clinic telemedicine visit using an iPAD during which participants will be audio- and visually-recorded in order for the research team to collect raw facial expression data; 2) be instructed to complete a series of activities of daily living (e.g., sitting down and brushing hair) during which participants will be audio- and visually-recorded in order for the research team to collect raw body motion tracking data; and 3) complete a participant satisfaction survey via a REDCap link and participate in an audio-recorded, semi-structured interview (e.g., asking the participants thoughts on privacy considerations related to future use of the facial expression and body motion technology in a home environment) with members of the research team.
15782572|NCT04592614|Behavioral|Choose to Move - Next Steps|Choose to Move - Next Steps consists of a series of group meetings delivered virtually for 2 years. Group meetings (1-hr each) of 6-11 older adults will be facilitated by a trained Activity Coach and delivered remotely via the Zoom or GoToMeeting platform (password protected; access through phone or internet). Each group meeting will provide information on a health-related topic of interest and will include time for goal setting, discussion and sharing among participants. Older adults will have the option to sign up for a bi-weekly CTM electronic newsletter containing health information and ideas and resources for older adults to be physically active and socially connected at home (and elsewhere as local restrictions permit). Activity Coaches will also facilitate social connections between participants to encourage contact (by phone or online) outside of group sessions (for interested participants only).
15782573|NCT04592601|Procedure|S.L.I.M.M.S. Procedure|Combined Gastric Bypass with Vertical Sleeve Gastrectomy
15782574|NCT04592588|Behavioral|Common Elements Toolbox|COMET is an online unguided self-help intervention that lasts approximately 45-60 minutes.
15782575|NCT04592588|Behavioral|Wait-list control|Participants in the control condition will receive access to the intervention after data collection for the study has been completed.
15782576|NCT04592575|Other|Vestibular Evaluation|Each patient will have a full vestibular evaluation by a physical therapist
15782577|NCT04592562|Device|the Terumo Hydropearl® microspheres device|"Genicular artery embolization (GAE) is a new, minimally invasive investigational not yet approved therapy. In previous studies, this procedure has provided pain relief in patients with mild to moderate OA in the short to midterm. We will be utilizing the Terumo Hydropearl® microspheres particle beads during the GAE procedures. The procedure will take place utilizing fluoroscopic and ultrasound guidance. Following catheterization of the femoral artery, angiography of the affected limb will be performed to define the genicular arterial anatomy. Genicular arteries demonstrating abnormal vascularity and corresponding to the site of the patient's pain will be catheterized and embolized using microspheres. Prior to and after embolization, parametric imaging will be performed utilizing proprietary software to quantify changes in blood flow to the target area
~The intended use of the Terumo Hydropearl® microspheres device is to embolize the geniculate artery branch."
15782578|NCT04592549|Drug|ADM03820|ADM03820 is a 1:1 mixture of two human IgG1 non-competitive binding anti-SARS-CoV-2 antibodies
15782579|NCT04592549|Other|Placebo|Placebo
15782584|NCT04592523|Other|No Intervention|This is a non-interventional study.
15782585|NCT04592497|Procedure|AF ablation|Prospective, single-center, non-randomized, open label, two arm study. After informed consent, 60 consecutive subjects who are scheduled to undergo AF ablation will be enrolled in the study in two equally sized groups of 30 subjects each. One group will undergo the procedure with assistance THERMOCOOL SMARTTOUCH SF-5D QDOT system and the other with the standard Thermocool Smartouch SF system. Data will be collected from all subjects during the ablation procedure and post procedure for a period of 12 months. Data will be anonymized by removing patient protected health information, only initials will be used.
15782586|NCT04592484|Biological|CDK-002|CDK-002 administered intratumorally
15782587|NCT04592471|Device|kneeMID500-STRONG700|At least 30 patients (15 patients in the orthosis group and 15 patients in the control group) per device type (2 device types: Knee MID 500 and Knee STRONG 700) totalling 60 patients will be included. Patients included in the orthosis group will use the device during sports sessions while patients included in the control group will not use a knee support device.
15782588|NCT04592458|Biological|β-globin restored autologous HSC|β-globin restored autologous HSC modified with lentiviral vector LentiHBBT87Q
15782589|NCT04592445|Device|Satera GSN Ablation|The Axon procedure consists of a small needle puncture made in the groin to pass standard sheaths, wires, and access devices into the femoral vein, using standard access methods. The right GSN will be ablated transvenously from the right intercostal veins where it crosses at the 10th and 11th thoracic vertebrae from the intercostal vein intersection with the azygos vein. Placement of the access devices and Axon catheter is confirmed using standard fluoroscopic imaging. Once positioning is confirmed, GSN ablation can commence accordingly .
15782590|NCT04592445|Device|Sham Control|The sham procedure consists of a small needle puncture made in the groin to pass a standard femoral introducer sheath approximately 10 cm into the femoral vein, using standard access methods. The Axon Catheter and associated access accessories will not be inserted into the patient. The sham procedure duration will be similar to the treatment time for subject receiving the Axon therapy (~30 minutes).
15782628|NCT04592146|Device|Frailty multicomponent intervention supported by POSITIVE|This technology mainly consists in a home monitoring kit periodically measuring gait speed, involuntary weight loss and power in the lower limb. Furthermore, through a tablet device, other relevant information (e.g. state of mind, activities of daily living-ADLs, etc.) is collected. The same device is used to enhance communication with the clinical team and follow the tailored intervention
15782591|NCT04592432|Other|SIGN@L-A|Two prototypes of a serious game were developed as part of this study. The design of these prototypes is based on the conceptual model by Alexiou and Schippers (2018) linking the instructional design of a serious game to intrinsic motivation, engagement, and learning outcomes. The design of SIGN@L-A will include all elements of the serious game instructional design proposed by these authors which are game mechanics (i.e., objectives to meet, feedback, and rewards), a narrative (i.e., a protagonist, non-playable characters, and narrative events), and aesthetics (i.e., functional and hedonic aesthetics).
15782592|NCT04592432|Other|SIGN@L-B|The design of SIGN@L-B will include only some of these elements which are some of the game mechanics (i.e., objectives to meet, limited feedback), and a functional aesthetic.
15782593|NCT04592419|Drug|KSI-301|Intravitreal Injection
15782594|NCT04592419|Drug|Aflibercept|Intravitreal Injection
15782595|NCT04592419|Other|Sham Procedure|The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
15782596|NCT04592406|Other|CVP screening|An appropriate dual screening process including both renal and cardiac parameters to minimize the risks of post-contrast renal adverse outcomes and of prophylactic hydration in eGFR<30mL/min/1.73m2 patients.
15782597|NCT04592393|Diagnostic Test|Abbreviated PB MRI|Annual non-contrast PB MRI.
15782598|NCT04592393|Genetic|Gene mutation test|K-ras and GNAS mutation test. Being performed once as a baseline test at the enrollment.
15782599|NCT04592393|Diagnostic Test|Conventional follow-up|Any of followings: scheduled CECT, MRI, USG, EUS, tumor marker (CA 19-9) during the study period.
15782600|NCT04592380|Drug|Stage 1: Clevidipine (double-blinded)|Patients may be transitioned to an oral antihypertensive medication as necessary. When such a transition is required, then approximately 1 hour prior to the anticipated cessation of the double-blinded clevidipine infusion, an oral antihypertensive agent may be administered. The clevidipine infusion may be down-titrated or terminated at any time following administration of the oral agent, in order to achieve the desired BP level.
15782601|NCT04592380|Drug|Stage 1: Placebo (double-blinded)|Patients may be transitioned to an oral antihypertensive medication as necessary. When such a transition is required, then approximately 1 hour prior to the anticipated cessation of the double-blinded placebo infusion, an oral antihypertensive agent may be administered. The placebo infusion may be down-titrated or terminated at any time following administration of the oral agent, in order to achieve the desired BP level.
15782602|NCT04592380|Drug|Stage 2: Clevidipine (open-label)|Patients may be transitioned to an oral antihypertensive medication as necessary. When such a transition is required, then approximately 1 hour prior to the anticipated cessation of the clevidipine infusion, an oral antihypertensive agent may be administered. The clevidipine infusion may be down-titrated or terminated at any time following administration of the oral agent, in order to achieve the desired BP level.
15782603|NCT04592380|Drug|Stage 2: Standard of Care (open-label)|Transition to oral antihypertensive medication from SOC IV antihypertensive is per institutional practice.
15782604|NCT04592367|Procedure|Patient age at time of procedure of reconstruction of ACL|Primary reconstruction of ACL with no other concomitant ligament reconstructions. Treatment of cartilage og meniscal injury may be a part of the procedure
15782605|NCT04592354|Dietary Supplement|Oxaloacetate Medical Food/Dietary Supplement|500 mg Anhydrous Enol-Oxaloacetate BID
15782606|NCT04592341|Drug|Gantenerumab|Gantenerumab will be administered by SC injection at a dose of 120 mg Q4W for 12 weeks, followed by 255 mg Q4W for 12 weeks, and 255 mg Q2W for another 12 weeks, followed by the target dose 255 mg Q1W for up to Week 103.
15782607|NCT04592328|Other|Bacterial cultures taken during surgery.|Cultures taken from skin, subcutaneous tissue, surigal materials and surgical gloves at incision and after two hours.
15782608|NCT04592315|Drug|Lipovirtide Injection|Single dosage of Lipovirtide Injection
15782609|NCT04592302|Diagnostic Test|Blood Draw|2-4 weeks before surgery a blood draw will be taken to test for nicotine levels in the body
15782610|NCT04592289|Procedure|Full bowel preparation|MBP+OA
15782611|NCT04592289|Procedure|Mechanical bowel preparation only|MBP
15782612|NCT04592276|Dietary Supplement|PS128|Participants took two capsules with PS128 after dinner for 30 days.
15782613|NCT04592276|Dietary Supplement|placebo|Participants took two capsules without PS128 after dinner for 30 days.
15782614|NCT04592263|Other|EPD Questionnaire|A 44 items questionnaire (4 point likert scale) was distributed. Included dimensions where: experience with your physician, provision of care, barriers, outcomes of care, symptoms, patient engagement, health literacy and patient empowerment.
15782615|NCT04592250|Other|Survey Administration|Complete survey
15782616|NCT04592237|Drug|Cabazitaxel|Given IV
15782617|NCT04592237|Drug|Carboplatin|Given IV
15782618|NCT04592237|Biological|Cetrelimab|Given IV
15782619|NCT04592237|Drug|Niraparib|Given PO
15782620|NCT04592211|Drug|olaparib+pembrolizumab+paclitaxel|olaparib, 100~200mg, PO, bid, continuous pembrolizumab 200mg, IV, q 3 weeks paclitaxel 175g/m2 IV, q 3 weeks
15782621|NCT04592198|Drug|Palonosetron Hydrochloride Buccal Film 0.25 Mg|Dose equal to the iv control
15782622|NCT04592198|Drug|Palonosetron Hydrochloride Buccal Film 0.5 Mg|Dose twice that of iv control
15782623|NCT04592198|Drug|Palonosetron Hydrochloride, 0.25 Mg/5 mL Intravenous Solution|iv control
15782624|NCT04592185|Device|Fenestrated Anaconda™ Device|Treatment of complex abdominal aortic aneurysms
15782625|NCT04592172|Behavioral|Bedtime Routine Education|The intervention aims to promote healthy sleep and improved developmental outcomes in infants. Individualized bedtime routine education, including such activities as a bath, teeth-brushing, reading stories, singing songs, and cuddling will be implemented by research assistants at the 12-month well-child visit. Reinforcement of the bedtime routine education will be implemented at the 15-month visit. Each individualized bedtime routine will incorporate 3-5 steps and a bedtime routine chart depicting those steps will be created and provided to the families. Families will receive materials for their bedtime routines, including a CuddleBright kit, 1-2 additional bedtime books, toothbrush/toothpaste , and the created bedtime chart. On top of that, families will also receive a children's book provided by Reach Out and Read through the study period.
15782626|NCT04592159|Drug|Nabiximols|oromucosal spray
15782627|NCT04592159|Drug|Placebo|oromucosal spray
15782631|NCT04592120|Behavioral|Coalition Check-Up|The Coalition Check-Up identifies and addresses coalition and implementation capacity deficiencies that frequently lead to failure, following recommendations from the audit and feedback literature.
15782632|NCT04592107|Diagnostic Test|eGFR|estimated glomerular filtration rate
15782633|NCT04592094|Device|Blueback® Physio|Blueback® Physio is monitoring the activation level of the transversus abdominis muscle in real time during the exercises
15782634|NCT04592081|Drug|Dextenza 0.4Mg Ophthalmic Insert|Dextenza 0.4Mg Ophthalmic Insert
15782635|NCT04592068|Device|Retinal multi-diseases diagnosed by DL algorithm|DL algorithm automatically classify multi-diseases from fundus photography and differentiate major vision-threatening conditions and other retinal abnormalities.
15782636|NCT04592068|Other|Retinal multi-diseases diagnosed by expert panel|Expert panel classifies multi-diseases from fundus photography and differentiate major vision-threatening conditions and other retinal abnormalities.
15782637|NCT04592042|Behavioral|Feel-Good- Group|Eight sessions of group intervention focussing on information on emotion regulation, training of emotion regulation techniques and mindfulness.
15782638|NCT04592029|Drug|TACE combined with sintilimab and bevacizumab|Sintilimab and bevacizumab are administered at 3-7 days after the first TACE. The study includes dose escalation and dose expansion stage. 6-9 subjects will be enrolled in dose escalation stage for the safety and efficacy evaluation. Then, Sintilimab 200mg/kg IV. q3w+ select specific dose of bevacizumab (7.5mg/kg or 15 mg/kg IV. q3w), expand to 36-39 patients for the further safety and efficacy study. The study treatment of sintilimab and bevacizumab lasts up to 24 months. TACE can be repeated when indicated clinically.
15782639|NCT04592016|Drug|Voltaren - Diclofenac sodium gel 1% (GSK, USA)|Topical application in dermal-sampling visit
15782640|NCT04592016|Drug|Pennsaid 2 % Topical Solution (Horizon Therapeutics, USA)|Topical application in dermal-sampling visit
15782641|NCT04592016|Drug|Diclofenac sodium gel 1% (Perrigo, USA)|Topical application in dermal-sampling visit
15782642|NCT04592016|Device|Dermal open flow microperfusion - Pilot|Dermal open flow microperfusion will be used to collect interstitial fluid in order to assess diclofenac concentration in the dermis. Interstitial fluid (ISF) sampling: 1 hour pre-dose and 24 hours post-dose.
15782643|NCT04592016|Device|Dermal open flow microperfusion - Pivotal|Dermal open flow microperfusion will be used to collect interstitial fluid in order to assess diclofenac concentration in the dermis. Interstitial fluid (ISF) sampling: 1 hour pre-dose and 12 hours post-dose.
15782644|NCT04592016|Procedure|Blood sampling - Pilot|1 sample is taken pre-dose and 24 samples are taken post-dose.
15782645|NCT04592016|Procedure|Blood sampling - Pivotal|1 sample is taken pre-dose and 12 samples are taken post-dose.
15782646|NCT04591990|Drug|Administration of AVP|Administration of AVP
15782647|NCT04591990|Drug|Administration of placebo AVP|Administration of placebo AVP
15782648|NCT04591990|Drug|Administration of placebo hydrocortisone|Administration of placebo hydrocortisone
15782649|NCT04591990|Drug|Administration of hydrocortisone|Administration of hydrocortisone
15782650|NCT04591977|Device|HPV Self-Sampling Kit (Evalyn Brush)|The Evalyn Brush is a self-sampling kit that can be used to collect a sample to screen for HPV/Cervical cancer at home.
15782651|NCT04591964|Combination Product|"mobile application M-Cardio based on android"|"Mobile apllication M-Cardio (android) for remote monitoring of patients with CHF developed on algorithms of clinical indicators, that's give us to evaluate current condition of patient, depends from quantity points of abnormals higher or lower threshold values, with automatically notification for doctor and patient for timely medical service."
15782652|NCT04591951|Behavioral|I2-ART|Based on the Parent Empowerment Program model, I2-ART will use methods of adult learning, direct instruction to share knowledge or techniques for practice, modeling, vicarious learning, and practice opportunities (i.e., role rehearsals). The research team will provide the family navigators with 3 months of I2-ART training, including 40 hours of didactic and interactive sessions (10 sessions of 4 hours each). Following training, the family navigators will implement the 3-month I2-ART intervention with the caregivers, including a 2-hour face-to-face meeting, at least three monthly in-person meetings, and intermittent contact between in-person meetings by phone calls, texts or emails, as determined by the family navigator-caregiver dyad.
15782653|NCT04591951|Other|Usual care|Care as usual
15782654|NCT04591938|Device|Fantom Encore Bioresorbable scaffold implantation|Fantom Encore Bioresorbable scaffold implantation
15782655|NCT04591925|Device|Control Device insulin infusion devcie|Control Device - Commercially available insulin infusion device using a soft Teflon indwelling cannula
15782656|NCT04591925|Device|Investigative insulin infusion devcie|Investigative insulin infusion device with coil-reinforced soft polymer indwelling cannula
15782657|NCT04591912|Behavioral|mind. body. voice|The mbv program consists of 10 weekly sessions that include a variety of practices, including: cognitive dissonance exercises, contemplative practices, guided discussion and community building.
15782658|NCT04591899|Device|CAD/CAM splints|"Each of the maxillary and mandibular cast will scanned alone and then both scanned together in the centric relation using FREEDOM HD scanner1.
~The CAD/ CAM splint will be designed using Exocad software; the design will be the same as the conventional one. The surveying will be done by the software and the under-cuts blocked.
~The splints will be printed using Dent2 3D printer and then cured using Dentcure. The CAD/CAM splints material will be hard resin from PhotoCentric 3D."
15782659|NCT04591886|Behavioral|mind. body. voice.|The mbv program consists of 10 weekly sessions that include a variety of practices, including: cognitive dissonance exercises, contemplative practices, guided discussion and community building.
15782660|NCT04591873|Other|telemedicine|Using telemedicine system to communicate
15782661|NCT04591873|Other|traditional communication tools|Use telephone or direct verbal communication
15782662|NCT04591860|Device|Laparoscopic or robot-assisted hiatal closure (sutures only vs. absorbable mesh vs. pledgeted sutures) and fundoplication according to Toupet|Patients are scheduled to undergo laparoscopic or robot-assisted surgery for a large symptomatic hiatal hernia.The hiatal closure will be done with sutures, pledgeted sutures or absorbable mesh (Phasix™ST mesh). After cruroplasty a fundoplication according to Toupet will be done additionally.
15782663|NCT04591847|Drug|Vitamin D 2|Vitamin D2 20000IU 1 tab oral weekly
15782664|NCT04591847|Drug|Placebo drug|Placebo drugs 1 tab oral weekly
15782665|NCT04591834|Other|Observational|An observational study in subjects with the severe form of MPS II.
15782666|NCT04591808|Drug|Atorvastatin/Perindopril|1 over-encapsulated S05167 capsule, fixed dose combination of Atorvastatin/Perindopril Arginine 40/10 mg, will be administered once daily each day before breakfast during 8 weeks.
15782667|NCT04591808|Drug|Atorvastatin|1 over-encapsulated atorvastatin 40 mg tablet will be administered once daily each day before breakfast during 8 weeks.
15782668|NCT04591808|Drug|Perindopril|1 over-encapsulated perindopril 10 mg tablet will be administered once daily each day before breakfast during 8 weeks.
15782669|NCT04591795|Drug|Sahastara remedy extract|The concentration of SHT extract is 100 mg per capsule
15782670|NCT04591795|Drug|Diclofenac|Diclofenac sodium, 25 mg enteric-coated tablets
15782671|NCT04591782|Other|PomJuice|Drink 8 oz pomegranate juice
15782672|NCT04591782|Other|Water|Drink 8 oz water
15782673|NCT04591782|Other|Sugar Water|Drink 8 oz of water with 18.6 g of glucose + 18.3 g of fructose dissolved in
15782674|NCT04591769|Device|Different tracheal tube cuff design|Comparison of effect between 2 different designs of tracheal tube cuff
15782675|NCT04591756|Other|Qualitative Fit Testing|Qualitative fit testing with denatonium benzoate
15782676|NCT04591743|Device|Active TCS|TCS active at 1 Hz on the right DLPFC for 6 weeks
15782677|NCT04591743|Device|Placebo TCS|Inactive TCS (placebo coil) at 1 Hz on right DLPFC for 6 weeks
15782678|NCT04591743|Drug|nicotine treatment|at least 21/14/7 mg/d + oral nicotine cp from 2 to 30 mg/d)
15782679|NCT04591743|Other|Questionnaires|"EVA on craving, TCQ, QSU, BDI-II, CO tester, IGT, BART"
15782680|NCT04591730|Other|First time father questionnaire self-administration|The first-time father questionnaire will be self-administrated to subjects 1 month post-birth.
15782681|NCT04591717|Biological|hAd5-S-Fusion+N-ETSD vaccine|The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
15782682|NCT04591704|Other|hospitalisation, necessity of ICU, mortality rate, lung involvement|hospitalisation, necessity of ICU, mortality rate, lung involvement
15782683|NCT04591678|Drug|nusinersen|SPINRAZA (nusinersen) is FDA approved to treat spinal muscular atrophy (SMA) through intrathecal injection.
15782684|NCT04591665|Other|swallowing examination|patients received swallowing examination, including high resolution impedance manometry and Video-Fluoroscopic swallowing study.
15782685|NCT04591652|Drug|99mTc-MIRC208|99mTc-MIRC208 SPECT/CT: after intravenous injection of 14.8 MBq/kg body weight of quality-controlled 99mTc-MIRC208 2 h, a Siemens Symbia T16 SPECT/CT scan will be performed within 1 h.
15782686|NCT04591639|Drug|Dapagliflozin 10 milligrams [Farxiga]|Patients with heart failure with or without type 2 diabetes will be either randomised to 10mg Dapagliflozin once daily or matched placebo.
15782687|NCT04591639|Drug|Placebo|Patients with heart failure with or without type 2 diabetes will be either randomised to 10mg Dapagliflozin once daily or matched placebo.
15782691|NCT04591613|Other|Questionnaire|Quality of life and chronic disease impact scales will be completed at inclusion and follow-up visits.
15782692|NCT04591613|Other|Biocollection|Total serum, plasma samples will be collected
15782693|NCT04591613|Other|Follow-up visit|All patients will make an inclusion visit (IV), then a clinical follow-up will be organized for the study at M4, M6, M12 from the day of the onset of the 1st symptoms of COVID.
15782694|NCT04591600|Drug|Ivermectin and Doxycyline|Ivermectin 200ug/kg PO per day for two days, and in some patients who needed more time to recover, a third dose 200ug/kg PO per day was given 7 days after the first dose. Doxycycline 100mg capsule PO every 12h per day was given for 5-10 days, based on the clinical improvement of patients. In addition, standard care was given to the patients of Ivermectin-Doxycycline group based on the clinical condition of each patient.
15782695|NCT04591600|Drug|Standard of care|"Standard care
~Acetaminophen 500mg on need
~Vitamin C 1000mg twice/ day
~Zinc 75-125 mg/day
~Vitamin D3 5000IU/day
~Azithromycin 250mg/day for 5 days
~Oxygen therapy/ C-Pap if needed
~dexamethasone 6 mg/day or methylprednisolone 40mg twice per day, if needed
~Mechanical ventilation, if needed"
15782696|NCT04591587|Procedure|Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery|Lenticule Implantation in Keratoconus Disease with RELEX Smile Surgery using VisuMax Femtosecond laser- Smile module surgery with primary objective to increase central corneal thickness and secondary objective to improve visual acuity and reduces K-values
15782697|NCT04591574|Biological|Red Blood Cells (Transfusion)|Participants will receive RBC transfusions in accordance with trial protocol (intervention group) or usual care, which is in accordance with the NICE guidelines
15782698|NCT04591548|Diagnostic Test|proteomic analyses, ELISA validation of peritoneal fluid, blood and uterine fluid sample|All samples were collected during laparoscopy, before any intraabdominal procedure was done. Indication for surgery was clinical (not for research purpose). All sample collection procedures was mimic regular clinical procedures.
15782699|NCT04591535|Drug|WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETS|WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETS
15782700|NCT04591522|Other|Healthy fecal bacteria liquid|Fecal bacteria liquid were obtained from healthy people by a feces processor, and perfused into the patient's intestine.
15782701|NCT04591496|Behavioral|Behavioral change intervention;|Behavioral change intervention: goal setting, regarding child's diet and parental feeding practices; self-monitoring, with observation and recording of the child's food intake and parental feeding practices; individualized feedback, based on preceding week monitoring and according to the defined objectives, regarding child's and parent's behaviors; modeling and direct suggestions by tailored parent figures; positive reinforcement associated to parents' accomplishment of the objectives; prompts, to remember the defined objectives and the main messages of the intervention.
15782702|NCT04591496|Behavioral|Health Education|Health education: provision of information about preschool children's nutrition guidelines, effective parental feeding practices, strategies to overcome food and feeding-related barriers, and steps to form healthy habits.
15782703|NCT04591470|Diagnostic Test|Mar test|Study of antisperm antibodies
15782704|NCT04591457|Drug|Insulin Glargine Sansulin|Insulin Glargine (Sansulin Log-G) once daily at individually adjusted dose
15782705|NCT04591457|Drug|Insulin Glargine Pen Injector [Lantus]|Insulin Glargine (Lantus) once daily at individually adjusted dose
15782706|NCT04591444|Drug|Fluoride Varnish|Following the manufacturer's recommendations, it was not necessary to moisten or dry the treated surface beforehand or afterwards. The product was dispensed and manipulated for 15 s until a homogeneous mixture was obtained, applied with a micro brush, flowing into interproximal areas, and quickly adhering to the tooth surface in the presence of saliva.
15782707|NCT04591444|Drug|Glass Ionomer Sealant|Following the manufacturer's recommendations, prophylaxis and prior drying of the treated surface was carried out, the product was also dispensed and manipulated for 15 s until a homogeneous mixture was obtained, applied with a micro brush and light-cured for 20 s.
15782708|NCT04591444|Other|Placebo Group|4 weeks after the simulation of the treatment application, participants in the placebo group received DH treatment with the product that had the best effect in the first 4 weeks.
15782709|NCT04591431|Drug|Erlotinib|TT arm
15782710|NCT04591431|Drug|Trastuzumab|TT arm
15782711|NCT04591431|Drug|Trastuzumab emtansine|TT arm
15782712|NCT04591431|Drug|Pertuzumab|TT arm
15782713|NCT04591431|Drug|Lapatinib|TT arm
15782714|NCT04591431|Drug|Everolimus|TT arm
15782715|NCT04591431|Drug|Vemurafenib|TT arm
15782716|NCT04591431|Drug|Cobimetinib|TT arm
15782717|NCT04591431|Drug|Alectinib|TT arm
15782718|NCT04591431|Drug|Brigatinib|TT arm
15782719|NCT04591431|Drug|Palbociclib|TT arm
15782720|NCT04591431|Drug|Ponatinib|TT arm
15782721|NCT04591431|Drug|Vismogedib|TT arm
15782722|NCT04591431|Drug|Itacitinib|TT arm
15782723|NCT04591431|Drug|Ipatasertib|TT arm
15782724|NCT04591431|Drug|Entrectinib|TT arm
15782725|NCT04591431|Drug|Atezolizumab|TT arm
15782726|NCT04591431|Drug|Nivolumab|TT arm
15782727|NCT04591431|Drug|Ipilimumab|TT arm
15782728|NCT04591431|Drug|Pemigatinib|TT arm
15782729|NCT04591431|Drug|Oncology Drugs|Standard of Care Arm
15782730|NCT04591418|Device|Rotary handpieces|Dental Caries removal
15782731|NCT04591418|Device|Er:YAG laser|Dental Caries removal
15782732|NCT04591405|Biological|Attenuated Mumps vaccine (KMB-17) in phase II and III|≥4.3logCCID50/ml Attenuated Mumps vaccine (KMB-17)[≥4.3 logCCID50/ml] in 360 children (5-11 years old) on 0 day
15782733|NCT04591405|Biological|Placebo in phase II|Freeze-dried stabilizer and diluent without mumps virus antigen in 360 children (5-11 years old) on 0 day
15782734|NCT04591405|Biological|Attenuated Mumps vaccine (KMB-17) in phase III|≥4.3logCCID50/ml Attenuated Mumps vaccine (KMB-17)[≥4.3 logCCID50/ml] in 5640 children (5-11 years old) on 0 day
15782735|NCT04591405|Biological|Placebo in phase III|Freeze-dried stabilizer and diluent without mumps virus antigen in 5640 children (5-11 years old) on 0 day
15782736|NCT04591392|Device|reSept ASD Occluder|Transcatheter closure of secundum ASD using a permanent implant
15782737|NCT04591379|Drug|Influenza Vaccines|Intratumoral application of an unattenuated influenza vaccine
15782738|NCT04591366|Other|Barrier dressing|A barrier dressing will be applied either pre or post implant prior to a culture swab and closing the incision.
15782739|NCT04591353|Drug|PENG Block|The pericapsular nerve group (PENG) block is a novel regional anesthesia technique for providing analgesia after hip fractures and hip arthroplasties.
15782740|NCT04591353|Drug|Lidocaine|2-3 cc of 2% lidocaine and NO bolus of bupivacaine will be injected.
15782741|NCT04591340|Dietary Supplement|dietary advice, oral nutritional supplement, supplementary parenteral nutrition or total parenteral nutrition|All HSCT(hematopoietic stem cell transplantation) patients should be accepted dietary advice or oral nutritional supplement, if their energy intake will not reach 60% of the goal level during the transplanting, then supplementary parenteral nutrition or total parenteral nutrition.
15782742|NCT04591327|Procedure|The Effect of General Anesthesia and Spinal Anesthesia on Postoperative Atelectasis by Lung Ultrasonography in Cesarean Sections|Preoperative lung ultrasound will be performed on all patients and baseline values will be recorded. The sensory block level under T10 of the patients who underwent spinal anesthesia in the postoperative period lung ultrasonography will be done after regression. In the postoperative period, lung ultrasonography will be performed in patients undergoing spinal anesthesia when the sensory block level is below T10. In the general anesthesia group, when the neuromuscular block is completely reversed and the Aldrete score is> 9, lung ultrasonography will be performed. The degree of atelectasis will be determined according to the modified LUS score.
15782743|NCT04591314|Behavioral|Neurofeedback|The intervention by neurofeedback (NF) will consist in providing the subjects with a feedback on their EEG Theta / Beta activity in real time Each subject will perform 8 sessions of neurofeedback (1h30 / session, 40 min of effective training by neurofeedback) at an average rate of 1 to 2 sessions per week.
15782744|NCT04591301|Drug|HEC113995 PA•H2O tablets|Each dose of HEC113995 PA•H2O tablets will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.
15782745|NCT04591301|Drug|Placebo tablets|Placebo tablets will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.
15782746|NCT04591288|Other|Functional Electrical Stimulation protocol|FES-assisted treadmill walking followed by a 12-week follow-up period. Subjects will train three times a week walking at a target speed corresponding to 60-80% of their age-predicted maximum heart rate. Each training session will consist of five six-minute walking bouts, with five-minute rest periods between bouts. Each treadmill bout consists of alternating one- minute intervals of FES on and FES off. For the last walking bout, the first three minutes will be FES-assisted on the treadmill and the last three minutes will be overground walking without FES assistance to promote carryover effects. Total walking time is 30 minutes and the entire training session lasts approximately 50 minutes.
15782747|NCT04591288|Other|Treadmill only protocol|We will implement a 12-wk Treadmill training protocol consisting of treadmill walking followed by a 12-week follow-up period. Subjects will train three times a week walking at a target speed corresponding to 60-80% of their age. Each training session will consist of five six-minute walking bouts, with five-minute rest periods between bouts. Total walking time is 30 minutes and the entire training session lasts approximately 50 minutes.
15782748|NCT04591275|Drug|CMAB807 Injection|mAb targeting RANKL, human monoclonal antibody targeting RANKL
15782749|NCT04591275|Drug|Prolia®|mAb targeting RANKL, human monoclonal antibody targeting RANKL
15782750|NCT04591262|Drug|14C-PF-06826647-LR 600 mg PO|14C-PF-06826647-LR 600 mg with 300 nCi orally as extemp prep
15782751|NCT04591262|Drug|PF-06826647 600 mg PO|Unlabeled PF-06826647 600 mg
15782752|NCT04591262|Drug|14C-PF-06826647 100 ug IV|14C-PF-06826647 100 ug IV
15782753|NCT04591249|Behavioral|Physical activity intervention|Participants will 1) receive Fitbit, 2) be enrolled in a secure electronic platform to access Fitbit data, 3) receive 8-week remote counseling by a physical therapist that will include motivational interviewing and creating SMART goals (1 session per week) through a web-based teleconference platform, and 4) receive usual postoperative care directed by their surgeon. The first session will be 45 minutes and sessions 2-8 will be 30 minutes each. During the sessions, participant's confidence in meeting daily step goals will be assessed using a 0-10 scale. If self-reported confidence to meet their goal is <8, the physical therapist will help participants modify their goal using techniques such as problem-solving, positive statements and affirmations. Progression will be made only if daily steps goals are met for at least 4 out of 7 days a week. If this weekly step goal is not met, a physical therapist will help the participant identify solutions for realistic progression.
15782754|NCT04591249|Other|Usual care|Participants will receive postoperative care as determined by their treating surgeon. This includes lifting restrictions, advice to stay active, and oral analgesics as needed. Physical therapy referral will be at the discretion of the surgeon. However, physical therapy is not typically started until 12 weeks after surgery.
15782755|NCT04591236|Device|Brain stimulation|tDCS brain stimulation on leg motor areas was applied to Parkinson patients.
15782756|NCT04591236|Device|Treadmill gait training|Treadmill gait training was applied to Parkinson patients.
15782757|NCT04591223|Behavioral|Competency-based physical training (CbM)|The intervention to be added to online social work treatment as usual (OSW) is a well-designed, one-on-one structural physical workout module which will be offered by a licensed senior physical trainer in public sports ground or gymnasium. The aim is to strengthen participants' sense of competence, improve their physical fitness, self-confidence and self-image through an outcome-driven Circuit training. One of the chief advantages of Circuit training is its adaptability. Circuit training can be performed with gym equipment and/or bodyweight exercises which is deemed to be suitable for beginner and easy to practice at home on oneself. Participants can continue to replicate the exercise with or without any equipment. The program will be delivered in six one-hour sessions, including face-to-face and online mode, over one month.
15782758|NCT04591210|Drug|Angiotensin converting enzyme inhibitor|The study recommends physicians to select an ACEi with proven benefit in cardiovascular diseases such as perindopril, ramipril or enalapril. Lab values will be obtained during baseline. The patient will be followed by the physician clinically, with recommended laboratory testing in one week, including renal function, potassium assessment, and dose adjustments as appropriate.
15782759|NCT04591210|Drug|Angiotensin II Receptor Blockers|The study recommends physicians to select evidence-based ARBs such as candesartan or valsartan or losartan. Lab values will be obtained during baseline. The patient will be followed by the physician clinically, with recommended laboratory testing in one week, and dose adjustments as appropriate.
15782760|NCT04591184|Biological|Covigenix VAX-001 placebo|Placebo vaccine
15782761|NCT04591184|Biological|Covigenix VAX-001|Active Covigenix VAX-001
15782762|NCT04591171|Procedure|n-of-1 trial guided clinical decision making|The n-of-1 trial will, on the level of the individual patient, test which treatment strategy produces superior blood pressure reduction without unacceptable side effects. After discussion with the patient/caregiver dyad to identify whether they have specific concerns about particular medications, the nephrologist (clinician) will decide which two drugs and dosages will be tested in the n-of-1 trial (the protocol does not determine drug or dose). The two drugs chosen by the clinician will be assessed at clinician-selected dosing in a randomized treatment order (e.g., ABAB) for two weeks per treatment period and two treatment periods per drug.
15782763|NCT04591158|Device|Butterfly iQ|The Butterfly iQ is an ultrasound system that enable diagnostic ultrasound imaging and measurement of anatomical structures and fluids of adult and pediatric patients. It is a non-invasive device and does not impose any health hazards.
15782764|NCT04591145|Other|Observational group|Patient receive the standard bowel preparation strategy and routine colonoscopy
15782765|NCT04591132|Device|kinematic analysis|motor tasks appropriate for each diagnosis will be recorder with wearable inertial sensors
15782766|NCT04591119|Procedure|Transversus Thoracic Muscle Plane Block|40 ml %0.375 bupivacaine divided into 4 equal doses will be injected by the surgeon between internal intercostal muscle and transversus thoracis muscle at the 2nd and 3rd intercostal space and 4th and 5th intercostal space
15782767|NCT04591119|Procedure|Parasternal Intercostal Plane Block|40 ml %0.375 bupivacaine injection will be performed by ultrasound guidance after completion of surgery between psoas major muscle and external intercostal muscle at the 2nd and 3rd intercostal space and 4th and 5th intercostal space bilaterally by anesthesiologist.
15782768|NCT04591106|Diagnostic Test|Magnetic resonance imaging (MRI)|Magnetic resonance imaging (MRI) is a non-invasive imaging technique that uses a magnetic field and radio waves to create detailed images of the organs and tissues within the body.
15782769|NCT04591106|Diagnostic Test|Magnetic resonance elastography (MRE)|Magnetic resonance elastography (MRE) is a non-invasive imaging technique that uses a gently vibrating transducer in combination with MRI to create detailed images and maps of the mechanical properties, such as stiffness, of tissues within the body.
15782770|NCT04591106|Device|Prototype MRE soft flexible passive transducer paddle|The prototype device is provided to the investigators by Mayo Clinic under a Materials Transfer Agreement (MTA). The device is being used to promote comfort in the pediatric population; no formal data collection for regulatory submission is planned. The prototype device is smaller, softer, and more flexible than the commercial device and will be used where indicated by the subjects' size.
15782771|NCT04591093|Device|FineHearing Strategy with 10 more apical electrodes or with 10 more basal electrodes activated|Cochlear implant with FineHearing Strategy with 10 more apical electrodes activated or with 10 more basal electrodes activated
15782772|NCT04591080|Device|GUMMETAL Orthodontic Wire|Orthodontic archwire made of TiNbTaZr alloy.
15782773|NCT04591080|Device|Stainless Steel (CrNi)|"Stainless steel (18% Chromium and 8% Nickel) used as the control, and linked anteriorly to the GUMMETAL counterpart. Size of archwire is 0.016 x 0.022"
15782774|NCT04591067|Other|Testing of physical capacity|"This cross-sectional study will involve evaluation of physical capacity by assessment of:
~Gait function
~Muscle activity during walking
~Endurance during walking
~Hip muscle strength
~Hip range of motion
~Hip and muscle-tendon-related pain
~Hip and groin related patient-reported outcome measures (PROMs)"
15782775|NCT04591054|Device|Extended Vision IOL|Vivity IOL implantation following cataract extraction
15782776|NCT04591054|Device|Neutral Aspheric Monofocal IOL|enVista IOL implantation following cataract extraction
15782777|NCT04591041|Device|HoloSIM Software via Hololens 2|Medical students will train via a mixed reality simulated crisis scenario using the HoloSIM software on the Microsoft Hololens 2
15782778|NCT04591041|Other|Training by Mannequin Based Simulation|Medical students will train a via traditional mannequin based medical crisis scenario
15782779|NCT04591028|Drug|Indocyanine green|A one time injection of IDC prior to the day of scheduled surgery.
15782780|NCT04591015|Behavioral|Hospital: DD-CA|In the DD-CA group, participants will be offered a proven digital texting platform in their language of preference (Spanish/English) as part of the diabetes transitions discharge program with educational, motivational and medication adherence messaging that is currently an arm of our parent DD-ME grant with added COVID support messages that provide information addressing identified barriers in Hispanic underserved communities (e.g. obtaining testing supplies and medications, accessing routine medical care, and completing other important diabetes self-management behaviors such as healthful eating, exercise, social distancing, quarantine, and stay-at-home/lockdown guidelines).
15782781|NCT04591015|Behavioral|Hospital: Usual Care (UC)|In the UC group, participants will not receive the added COVID support messages, both groups will have a referral placed to the Diabetes Transitions Service (DTS) at the time of discharge as part of usual care. Participants will be contacted by a peer health coach following protocol to coordinate care with outpatient health and other community resources.
15782782|NCT04591002|Drug|Osimertinib 80 MG|Osimertinib is an oral, potent, selective, irreversible inhibitor of both EGFR-TKI sensitising and resistance mutations in NSCLC with a significant selectivity margin over wild-type EGFR. Osimertinib will be administered orally as one 80 mg tablet once a day (1 cycle is 28 days). Cycles are repeated until disease progression, unacceptable toxicity, or until 1 year after the initiation of osimertinib administration.
15782783|NCT04590989|Other|Personalized Nutrition Plan|"Personalized breakfasts and dinners designed and cooked by Simplefeast, delivered twice a week (eaten 6 days per week) + access to Simplefeast's App for recipes of other meals not provided (i.e. lunches and Saturdays) which are designed to match the individual nutritional recommendations.
~Personalized behavioral change program via electronic push notifications by ONMI"
15782784|NCT04590989|Other|Non-Personalized Nutrition Plan|"Standard meals of breakfasts and dinners designed and cooked by Simple feast, based on general dietary recommendations, and delivered to participants twice a week. In addition, they will also have access to Simple feast's recipe App for other meals not provided. The recipes presented are generic, not personalized.
~Subjects in the control group will also be enrolled in the behavioral program by ONMI, but the program will not be personalized nor based on the same behavior change methodology as in the PP group. In other words, the control group will get information more than is triggered to take actual action (i.e. general guidelines that is available from the National Health Service and World Health Organization)."
15782785|NCT04590976|Other|Semi-Structured Interview Healthcare Professional|Interview
15782786|NCT04590976|Other|Semi-Structured Interview Patients|Interview
15782787|NCT04590976|Other|Think Aloud Interview Patients|Interview
15782788|NCT04590976|Other|Discrete Choice Experiment (DCE) Patients|DCE Questionnaire
15782791|NCT04590950|Other|Non interventional study|Non interventional study
15782792|NCT04590937|Drug|BI 730357|Film-coated tablet
15782793|NCT04590937|Drug|CRESTOR®|Film-coated tablet
15782794|NCT04590937|Drug|Lenoxin®|Tablet
15782795|NCT04590937|Drug|MetfoLiquid GeriaSan®|Oral solution
15782796|NCT04590937|Drug|Lasix®|Oral solution
15782797|NCT04590924|Procedure|Hip arthroscopy|Patients that had hip arthroscopic surgery 5 years ago will be invited for 5 year follow up. The surgical procedures consisted of femoral osteoplasty, labral refixation and acetabular osteoplasty
15782798|NCT04590911|Behavioral|Cognitive Enrichment Program (CEP)|Multimodal cognitive rehabilitation program for individuals having sustained a traumatic brain injury during older adulthood
15782799|NCT04590898|Device|Peri-device leakage closure after left atrial appendage occlusion|Peri-device leakage closure after left atrial appendage occlusion
15782800|NCT04590885|Behavioral|Couple Communication Skills Training|Participants attend six 60-minute sessions consisting of education and skills training to enhance cancer-related communication.
15782801|NCT04590885|Behavioral|Healthy Lifestyle Information|Participants attend attend six 60-minute sessions consisting of information and support across a range of cancer-related topics.
15782803|NCT04590859|Procedure|Block performed|Comparing block performed with penile blood flow
15782804|NCT04590859|Device|LMA placement|Placement of LMA for airway securement
15782805|NCT04590846|Behavioral|Constipation Health Education Intervention Course|"The 4-weeks health education includes three dimensions. The first is Causes and Hazards of Constipation. The second is Constipation Symptoms and Criteria. The third is Constipation Treatment Strategies and Prevention.
~Health education leaflets with 3 to 5 test questions in the weekly are distributed once a week, students will bring them back to parents, and parents need to complete the answers and sign after reading them."
15782806|NCT04590846|Behavioral|General Health Course|General courses about health issues according to the curriculum of each primary school.
15782834|NCT04590625|Drug|Apatinib Mesylate|apatinib one course will last 21 days.Oral administration at a dose of 250 mg, qd
15782835|NCT04590625|Drug|Abraxane|abraxane one course will last 21 days.Intravenously guttae at a dose of 260 mg/m2,d1
15782836|NCT04590625|Drug|Cis Platinum|cis-platinum one course will last 21 days.cis-platinum introperitoneal injection at a dose of 75-100 mg/m2,d1
15782837|NCT04590625|Drug|Carboplatin|carboplatin one course will last 21 days.carboplatin intravenous injection at a dose of AUC=5-6,d1
15782807|NCT04590833|Behavioral|Supervised walking on a treadmill|Each participant will be provided with an individualized target heart rate zone based on his/her age. Heart rate during exercise will be measured using a finger pulse oximeter. Following baseline measures, participants will receive instructions on how to use a finger pulse oximeter by a student. For participants who are not physically fit or are just engaging in regular exercise, they will be advised to start walking on a treadmill at a comfortable pace for 5 to 10 minutes at one time.46 Exercise duration and intensity will be progressed from week 3 to week 5, until participants will walk at 40-59% of heart rate reserve based on their age, which will be maintained throughout the study.
15782808|NCT04590833|Behavioral|Supervised stretching exercise|Following baseline measures, a student will demonstrate the use of a pulse oximeter and stretching movements to these participants. Starting on week 3, participants will do the prescribed stretching exercise 3 times a week, maintaining heart rate below 40% of heart rate reserve during exercise. Stretching will target all major muscle-tendon groups including shoulder, chest, neck, truck, lower back, hips, and legs. It will also involve a slow and constant motion that accounts for any physical limitations and physician-specified precautions
15782809|NCT04590820|Drug|Tazemetostat|tazemetostat is an oral, small molecule selective and S-adenosyl methionine (SAM) competitive inhibitor of histone methyl transferase EZH2.
15782810|NCT04590820|Drug|Rituximab|Rituximab is a chimeric monoclonal antibody against the protein CD20. Given either Intravenous or subcutaneous.
15782811|NCT04590807|Device|Posterior spinal fusion with pedicle screws|Implanting pedicle screws and rods
15782812|NCT04590807|Device|Anterior vertebral body tethering|Vertebral screws and cable
15782814|NCT04590781|Biological|XmAb18087|Monoclonal bispecific antibody
15782815|NCT04590781|Drug|XmAb18087 ± Pembrolizumab|XmAb18087 ± Pembrolizumab
15782816|NCT04590768|Other|Fermotein based meals|various meal products: bread, soup and an occasional burgers
15782817|NCT04590768|Other|Matching control meals with whey protein and wheat bran|various meal products: bread, soup and an occasional burgers
15782818|NCT04590755|Behavioral|Interactive father-child sessions and website|The Run Daddy Run intervention will consist of 5 (inter)active sessions for fathers and their children + 1 follow-up session, each session lasting 90 minutes. These sessions will be given to 8 groups of +- 13 families (fathers and their children), guided by 2 facilitators and will take place every 2 weeks, at a location in the neighborhood of fathers and children (e.g. school of the children). Additionally, a website will be available for the fathers and their children, with additional information about the project, tips and information about being active together (e.g. movement breaks, fundamental movement skills, etc.) and limiting screen time. In addition, fathers and their children will also log their goals on this website, and between two sessions (= a period of 2 weeks) they will be asked to keep track of their co-PA on this website, aiming to reach their goal.
15782819|NCT04590742|Drug|melatonin 6mg|6 weeks of melatonin (6mg) given to patient
15782820|NCT04590742|Drug|Placebo|Patient given 6 weeks of placebo tablet
15782821|NCT04590729|Behavioral|3-min Exercise Per 30 Min|This protocol involves 3 minutes of cycling on a stationary bike at 50 revolutions per minute and 1 kilopond every 30 minutes for 6 hours, totaling 36 minutes of cycling exercise.
15782822|NCT04590729|Behavioral|3-min Exercise Per 15 Min|This protocol involves 3 minutes of cycling on a stationary bike at 50 revolutions per minute and 1 kilopond every 15 minutes for 3 hours, totaling 36 minutes of cycling exercise.
15782823|NCT04590716|Other|Data Collection|This is a non-interventional study conducted on the participant's smartphones to record MG related symptoms and conditions.
15782824|NCT04590703|Biological|ALLO-ASC-DFU|Application of ALLO-ASC-DFU sheet to Diabetic Foot Ulcer. This study is a follow-up study without intervention.
15782825|NCT04590703|Procedure|Vehicle sheet|Application of Vehicle sheet to Diabetic Foot Ulcer. This study is a follow-up study without intervention.
15782826|NCT04590690|Other|Special diet|The research clinic will provide subjects with a special diet for six days. After six days of isocaloric sodium, calcium and fluid intake, the study team will analyze three sequential 24-hour urine compositions including supersaturation of calcium oxalate, calcium, and urine volume, as well as stool collections. We will also evaluate components of 24-hour urine composition, specifically supersaturation, and the microbial contributions to urinary composition in 72-hour stool samples simultaneously collected using shot-gun metagenomic sequencing in men and women 1 year after surgery.
15782827|NCT04590677|Other|Samples required from group 1 (procedure within observational study)|"Weekly maternal blood samples to be taken
~Daily urine samples to be collected
~One rectal swab at the initial visit only
~Weekly vaginal swabs
~Daily Heart rate monitoring (only applicable to a subset of women in group 1)"
15782828|NCT04590677|Other|Samples required from group 2 (procedure within observational study)|"Weekly maternal blood samples to be taken
~Daily urine samples to be collected
~One rectal swab at the initial visit only
~Weekly vaginal swabs"
15782829|NCT04590664|Drug|Verteporfin|Given IV
15782830|NCT04590651|Procedure|Cataract surgery|Routine phacoemulsification cataract surgery using the Alcon Centurion® device.
15782831|NCT04590651|Procedure|Cataract surgery with extra anterior chamber angle aspiration|Routine phacoemulsification cataract surgery using the Alcon Centurion® device. At the end of the case a one minute extra anterior chamber angle aspiration will be preformed after the removal of the viscoelastic agent.
15782832|NCT04590638|Other|tumescent with adrenaline|skin graft donor site of patients enrolled in this group will be injected subcutaneously with tumescent solution containing adrenaline to see the bleeding control of donor site.
15782833|NCT04590638|Other|tumescent without adrenaline|skin graft donor site of patients enrolled in this group will be injected subcutaneously with tumescent solution not containing adrenaline to see the bleeding control of donor site.
15783042|NCT04588896|Behavioral|Lifestyle modification programme|Lifestyle modification programme
15782838|NCT04590612|Drug|Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet|25mg-100mg tablets to be taken orally three times a day on an empty stomach
15782839|NCT04590612|Drug|Citalopram|20 mg tablet to be taken orally once and at the same time of the day, daily.
15782840|NCT04590599|Drug|IBI310+sintilimab|Humanized mAb targeting CTLA4 IBI310 plus sintilimab 200mg
15782841|NCT04590599|Drug|Placebo+sintilimab|Sintilimab 200mg +Placebo
15782842|NCT04590586|Drug|Standard of care|Standard of care (SoC) treatment for COVID-19 infection in line with institutional practice. The SoC may change as new information becomes available about treating COVID-19.
15782843|NCT04590586|Drug|Apremilast|Apremilast administered orally as a tablet.
15782844|NCT04590586|Drug|Apremilast placebo|Matching apremilast placebo administered orally as a tablet.
15782845|NCT04590586|Drug|Lanadelumab|Lanadelumab administered as an intravenous (IV) infusion.
15782846|NCT04590586|Drug|Lanadelumab placebo|Matching lanadelumab placebo (normal saline) administered as an intravenous (IV) infusion.
15782847|NCT04590586|Drug|Zilucoplan|Zilucoplan administered as a subcutaneous (sc) injection in the abdomen, thigh, or upper arm.
15782848|NCT04590586|Drug|Zilucoplan placebo|Matching zilucoplan placebo administered as a subcutaneous (sc) injection in the abdomen, thigh, or upper arm.
15782849|NCT04590573|Behavioral|Cognitive behavioural couple therapy (CBCT), Emotion focused couple therapy (EFCT), Wait-list control (Control)|5 sessions in CBCT, EFCT and Control (3 hours per session), 6-8 pairs of couples per group and around 7 groups will be held.
15782850|NCT04590560|Diagnostic Test|screening for breast cancer with tomosynthesis and synthetic 2D mammography performed at different interval compared to actual clinical practice|women will be screened for breast cancer using tomosynthesis and synthetic 2D mammography with an interval defined according to their randomization arm for a follow-up period of 6 years;
15782853|NCT04590534|Drug|Chromax|Treatment of BPH by Chromax for 3 Months
15782854|NCT04590534|Drug|Sildosin Group|patients will receive one capsule of Sidosin 8 mg once daily for 12 weeks
15782855|NCT04590534|Other|Placebo Group|patients will receive placebo 3 times daily for 12 weeks
15782856|NCT04590521|Biological|Gardasil®, Merck|Gardasil® (4vHPV) is a recombinant protein particulate (VLP) vaccine. Each 0.5 mL monodose pre-filled syringe or vial contains approximately 20 μg of HPV 6 L1 protein, 40 μg of HPV 11 L1 protein, 40 μg of HPV 16 L1 protein, and 20 μg of HPV 18 L1 protein as well as approximately 225 mcg of aluminum (as Amorphous Aluminum Hydroxyphosphate Sulfate adjuvant). It has completed phase III trials and is licensed for use in over 100 countries around the world including the United States, Australia and countries in the European Union (EU) for girls aged 9-26 years. Vietnam currently offer this vaccine in private health clinics, as a 3-dose schedule (0, 2 and 6 months).
15782857|NCT04590508|Drug|Xanthohumol|The xanthohumol supplement will be administered in a capsule and taken orally.
15782858|NCT04590508|Other|Placebo|The placebo will be administered in a capsule and taken orally.
15782859|NCT04590495|Drug|300 mg Cannabidiol (CBD) oil|Participant will either be given a 300mg dosage of CBD oil. After consumption of the study drug, the participant will wait for 120 minutes to allow for digestion and for CBD to begin taking effect. Next, individuals will undergo a driving simulation and all participants will drive the same course. The simulator presents the individual with real life driving scenarios and is equipped with screens, a steering wheel, signals, and pedals. The participant will be instructed to drive the course for 25-35 minutes. They will be instructed to follow normal driving rules. The simulation will include highway, suburban, rural, and urban driving scenarios which will incorporate turns, changes in speed, and avoidance of cars/pedestrians.
15782860|NCT04590495|Drug|Placebo|Participant will either be given a placebo . After consumption of the study drug, the participant will wait for 120 minutes to allow for digestion and for CBD to begin taking effect. Next, individuals will undergo a driving simulation and all participants will drive the same course. The simulator presents the individual with real life driving scenarios and is equipped with screens, a steering wheel, signals, and pedals. The participant will be instructed to drive the course for 25-35 minutes. They will be instructed to follow normal driving rules. The simulation will include highway, suburban, rural, and urban driving scenarios which will incorporate turns, changes in speed, and avoidance of cars/pedestrians.
15782861|NCT04590482|Drug|letrozole|Letrozole 2.5 mg each 12 hours for 2 days followed by vaginal misoprostol 800 mcg for induction of abortion
15782862|NCT04590482|Drug|placebo|placebo given twice daily for 2 days followed by 800mcg misoprostol vaginally to induce abortion
15782863|NCT04590469|Other|COVID WHELD|COVID WHELD is a COVID-19 adapted version of an established nursing home training intervention that confers benefits in well-being and neuropsychiatric symptoms for people with dementia. The adaptations include the development of digital resources to support the programme and virtual coaching.
15782864|NCT04590456|Other|PEMF|group A received 60 minutes of traditional program physical therapy which consisted of passive range of motion, stretching,proprioception, isotonic and isometric and 20 minutes of placebo treatment using PEMF, while group B received the same traditional physical therapy program given to the control group in addition of 20 minutes of PEMF therapy
15782866|NCT04590430|Drug|HFB30132A|Participants randomized to HFB30132A will be administered dose 1 in cohort 1. Participants in Cohort 2 and 3 will receive HFB30132A doses 2 and 3, respectively.
15782867|NCT04590430|Other|Placebo|Participants randomized to placebo will receive the same volume of solution as participants on active treatment.
15782869|NCT04590404|Behavioral|Post-discharge automated phone calls (IVR) with option to connect with a tobacco coach.|Automated calls to assess smoking status, medication use, and additional support for quit attempt.
15782870|NCT04590404|Drug|Nicotine Replacement Therapy|FDA-approved forms of nicotine replacement therapy for smoking cessation.
15782871|NCT04590404|Drug|Varenicline|FDA-approved smoking cessation medication.
15782872|NCT04590404|Other|Metabolism Informed Smoking Treatment (Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy)|Nicotine metabolite ratio (NMR)-based selection of pharmacotherapy. NMR is a blood test to measure how fast the body breaks down nicotine.
15782873|NCT04590391|Device|Visual and Auditory Breathing-swallowing Coordinated Training device|This device has a structure in which a band wrapped around the chest detects the respiratory phase from changes in the lung volume, and the connected device lights a signal and sounds a sound.
15782874|NCT04590378|Other|intensive care unit admission ratio|intensive care unit admission ratio
15782875|NCT04590365|Device|Carrageenan nasal and throat spray|Iota-carrageenan nasal and throat spray (verum Coldamaris plus i.e. Iota-Carrageenan 0.12% plus 0.04% Kappa-Carrageenan in 0.5% saline)
15782876|NCT04590365|Device|Saline nasal and throat spray|Saline nasal and throat spray (placebo Coldamaris sine i.e. 0.5% saline)
15782877|NCT04590352|Procedure|nasopharyngeal and throat swab|diagnostic specimens via nasopharyngeal swab and throat swab were collected following the current standard operating procedures.
15782878|NCT04590352|Procedure|collection of mucosal lining fluid|MLF will be collected via nasal absorption at the inclusion visit by study staff and four more time points by the parents or by the children themselves. Nasal absorption is performed by maneuvering a strip of synthetic absorptive matrices (SAM) into the lumen of the nostril, avoiding rubbing against the nasal mucosa. The outside of the nose is then pressed with a finger to cause apposition of the SAM against the mucosa.
15782879|NCT04590352|Procedure|blood collection via fingerprick|Participants will be asked to wash their hands with soap and warm water. The procedure involves cleaning the ball of the fingertip with an alcohol swab, then using a sterile disposable lancet to pierce the skin (BD Microtainer Lancet or similar). The lancet is placed in a spring-loaded device, which propels the lancet a fixed distance (a few mm) into the skin when the trigger is pressed. Approximately 10-20 drops of blood (0.3 ml) will then be collected with a sterile capillary tube. The participant is given a cotton wool pad to mop up any extra blood, and an elastoplast-type bandage is placed over the finger if necessary. Fingerprick blood samples will only be collected from participants older than 6 months at 28-32 days after the first home visit (d0). Lancet length will be adjusted for age (2.0 mm for participants 8 years and older, 1.5 mm for participants older than 6 months and younger than 8 years).
15782880|NCT04590339|Procedure|Guided inferior Alveolar Nerve lateralization|Evaluating neurosensory recovery after Implant placement in posterior atrophic mandible by Guided inferior alveolar nerve lateralization technique
15782881|NCT04590326|Drug|REGN5668|REGN5668 will be administered by once weekly intravenous (IV) infusion.
15782882|NCT04590326|Drug|Cemiplimab|For Module 1, after a minimum of a 3-week monotherapy lead-in of REGN5668, cemiplimab will be administered concomitantly every 3 weeks (Q3W) by IV infusion.
15782883|NCT04590326|Drug|REGN4018|For Module 2, a 4-week monotherapy lead-in of REGN4018 will be administered by once weekly IV infusion. After lead-in, REGN5668 and REGN4018 will be administered concomitantly.
15782884|NCT04590313|Procedure|Arthrodesis|MTPJ I arthrodesis
15782885|NCT04590300|Other|QUESTIONNAIRES|"1 questionnaire at the beginning of the study, before FTE program
~1 questionnaire at the end of FTE"
15782886|NCT04590274|Drug|Hydroxychloroquine|Hydroxychloroquine
15782887|NCT04590274|Dietary Supplement|Vitamins and Minerals|elemental Zinc Vitamin C Vitamin D3 N-acetylcysteine Elderberry Quercetin
15782888|NCT04590274|Drug|Azithromycin|Azithromycin
15782889|NCT04590261|Other|Blood sampling|Peripheral Blood sampling, 25 mL
15782890|NCT04590261|Other|Nasal Brushing|Nasal Brushing, facultative
15782891|NCT04590248|Drug|Adavosertib|The subjects will receive oral adavosertib 300 mg, once daily on Days 1 to 5 and Days 8 to 12 of a 21-day treatment cycle.
15782892|NCT04590235|Drug|Selumetinib|"All eligible subjects will first receive a single oral dose of selumetinib 25 mg/m^2. After a washout period of 2 days, oral selumetinib 25 mg/m^2 twice daily will be administered continuously. Subjects will continue to receive selumetinib until disease progression or unacceptable drug-related toxicity, whichever occurs first.
~10 mg and 25 mg capsules strengths available."
15782893|NCT04590222|Other|blood sample|One blood sample of 60 mL (EDTA)
15782894|NCT04590209|Other|Blood sampling|Recruited patients will be subjected to 2 blood samples of 7 mL at day 0 for serological analysis and cell collection and to an additional blood sample of 7 mL at day 15 for serological analysis
15782895|NCT04590209|Other|Skin biopsy|Recruited patients will be subjected to a single skin biopsy at day 0 for histological and transcriptomic analysis
15782896|NCT04590196|Drug|Longvida curcumin|longvida curcumin verdure sciences formulation
15782897|NCT04590196|Other|placebo|"Composition of Placebo :
~95.66% Maltodextrin 0.34% Sunset Yellow Color 0.06% Tartrazine Food Color 3.91% Silicon Dioxide"
15782898|NCT04590183|Drug|FK-506 (Drug)|Twice a day
15782899|NCT04590183|Drug|Prednisolone Acetate 1% Oph Susp|Four times a day
15782900|NCT04590170|Behavioral|Post-intensive Care unit syndrome|Post-intensive Care unit syndrome after an intensive care unit stay for the COVID19
15782901|NCT04590157|Device|Low Level Laser Therapy|Laser Acupuncture application on Neurogenic Acupoints: the treatment based upon the use of low power laser light to stimulate acupuncture points
15782902|NCT04590157|Other|Pelvic floor muscle training|exercise prodram as follow: from supine lying position with legs slightly apart the patient asked to contract the pelvic muscles as hard as possible and hold for 10 seconds
15782903|NCT04590144|Device|INVICTA lead|The implant or the attempt to implant an INVICTA lead
15782926|NCT04589936|Procedure|Prone positioning|Patient will first lay supine for a given time period, followed by lateral position on either side, then prone position, lastly return to supine position. Participants are anticipated to stay in prone position for a minimum of 30min to a maximum of 2 hours depending on tolerability. Participants will be guided in how to independently position themselves and rotate through the cycle of positions.
15782947|NCT04589832|Drug|PAC-1|Pharmacokinetic (PK) and pharmacodynamic (PD) assay for PAC-1 will be performed during Days 1 and 21 of Cycle 1. PAC-1 will be given on Day 1 of Cycle 1, withheld on Day 2 and Day 3 of Cycle 1 then reinitiated on Day 4 of Cycle 1 to continue for 21 days of the 28-day cycle. For each successive cycle, PAC-1 therapy will be initiated on Day 1 and continue for 21 days of the 28-day cycle.
15782904|NCT04590131|Procedure|recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent, supplemented by fasciotomy in Hunter's canal.|Under local anesthesia, a standard endovascular approach is performed. Transluminal or subintimal recanalization of the occluded arterial segment is performed with a hydrophilic guidewire. Next, balloon angioplasty of the recanalized segment is performed. After control angiography, a biomimetic interwoven nitinol stent is placed throughout the lesion. Immediately after the stenting procedure, under local anesthesia, access to the distal part of the SFA at the outlet of Hunter's canal and 1 portion of the popliteal artery is performed. The lamina vastoadductoria is dissected. The wound is sutured in layers. An aseptic bandage is applied. Drug therapy includes pre-procedure clopidogrel (160-300 mg/day), starting at least one day before, and intra-procedure heparin (100 U / kg body weight intravenously). After the procedure, all patients have prescribed double antiplatelet therapy (aspirin+clopidogrel (75 mg per day) within 6 months and then aspirin 75 mg for a long time.
15782905|NCT04590131|Procedure|recanalization of the femoral-popliteal arterial segment above the knee with angioplasty and stenting with a biomimetic interwoven nitinol stent.|Under local anesthesia, a standard endovascular approach is performed and the affected arterial segment is visualized. Transluminal or subintimal recanalization of the occluded arterial segment is performed with a hydrophilic guidewire. Next, balloon angioplasty of the recanalized segment is performed. After control angiography, a biomimetic interwoven nitinol stent is placed throughout the lesion. Drug therapy includes pre-procedure clopidogrel (160-300 mg/day), starting at least one day before, and intra-procedure heparin (100 U / kg body weight intravenously). After the procedure, all patients have prescribed double antiplatelet therapy (aspirin+clopidogrel (75 mg per day) within 6 months and then aspirin 75 mg for a long time.
15782906|NCT04590118|Drug|it-hMSC|Single intravenous infusion of it-hMSC for ischemic stroke patients
15782907|NCT04590118|Drug|Placebo|Single intravenous infusion of 1 ml/kg placebo
15782908|NCT04590105|Device|"Smartphone App SB Colonoscopy Prep"|We created a smartphone app that informs patients about their colonoscopy procedure, alerts them when to take their medications throughout the hours-long colonoscopy prep process and tells them when to arrive to the endoscopy suite.
15782909|NCT04590105|Other|Written Instruction|Written Instruction
15782910|NCT04590092|Device|Cooper Surgical Ring Pessary with Incontinence Knob|A pessary is a silicone ring with a knob that in inserted into the vagina to treat urinary incontinence by providing urethral support.
15782911|NCT04590079|Device|Conventional pain treatment with daily sessions with innovative medical device, Remedee One, for pain management by Millimeter Band Radiation|Conventional pain treatement with daily sessions with innovative medical device for pain management (radiation in millimeter band) at the rate of 1 to 3 sessions by day of 40 minutes for 3 months.
15782912|NCT04590066|Behavioral|Flu shot text messages|Participants will receive text messages per descriptions listed in the arms.
15782913|NCT04590053|Biological|Allocetra-OTS|Allocetra-OTS is a cell-based therapeutic composed of donor early apoptotic cells, comprising allogeneic mononuclear enriched cell suspension with at least 40% early apoptotic cells. The suspension is prepared with Ringer's lactate solution and administered IV. It is stored at 2-8°C until 20+25 minutes before infusion and at room temperature thereafter. Each dose contains 140x10E6 ± 20% cells/ kg of recipient body weight (at screening) in a total volume of 375 mL in a transfer pack that undergoes irradiation and is administered via an adjusted filter using a volumetric pump, at a starting rate of 48 mL/hour with a gradual increase every 15-25 minutes of 15 mL/hour to a maximal rate of 102 mL/hour. The study intervention should be completed within 72 hours of completing the manufacturing process. During product administration, no other IV fluids such as Ringer's lactate or normal saline will be given in parallel unless medically indicated due to volume depletion.
15782914|NCT04590040|Other|Placebo|0% nano-HAP toothpaste
15782915|NCT04590040|Device|15% nano-HAP toothpaste|Toothpaste with identical base formulation as the placebo containing 15% nano-HAP
15782916|NCT04590040|Device|5% KNO3 toothpaste|Toothpaste with identical base formulation as the placebo containing 5% KNO3
15782917|NCT04590014|Device|Control HVNI Device|During this session, patients will be placed on HVNI therapy using Vapotherm's conventional HVNI device design (Precision Flow). Patients will receive HVNI therapy through an appropriately-fitted Prosoft dual-pronged nasal cannula. Physiologic and ventilation parameters will be recorded.
15782918|NCT04590014|Device|Test HVNI Device|During this session, patients will be placed on HVNI therapy using Vapotherm's new HVNI device design (V2.0). Patients will receive HVNI therapy through an appropriately-fitted Prosoft dual-pronged nasal cannula. Physiologic and ventilation parameters will be recorded.
15782919|NCT04590001|Device|MobiusHD|The MobiusHD device is a nickel-titanium device that is implanted in the internal carotid sinus using a minimally invasive approach.
15782920|NCT04589988|Behavioral|Removing Environmental Barriers to Independent Living (REBIL)|REBIL is a complex intervention with two essential components: (1) removing environmental barriers and home hazards in the home tailored to the participant's unique abilities and limitations and (2) strategy training with the participant to help participant to be able to identify barriers in the home and community and identify potential resources and strategies to remove the barriers. Treatment includes one assessment session and four 75-minute visits in the home with an occupational therapist over 8 weeks, followed by a 6 -month assessment session by a blinded rater.
15782921|NCT04589988|Behavioral|Waitlist Attentional Control|The waitlist attentional control group will receive an initial assessment session then four 75 minute interview visits from an occupational therapy graduate assistant, followed by a 6-month assessment session by a blinded rater. After the 6-month follow-up is completed this group will receive the REBIL intervention.
15782922|NCT04589975|Procedure|laparoscopic surgery|
15782923|NCT04589962|Other|access axillary or brachial artery|access to the axillary or brachial artery during Transcatheter Aortic Valve Implantation (TAVI), Fenestrated/Branched-Endovascular Aortic Repair (F/BEVAR), chimney-EVAR (Ch-EVAR) or visceral side branches stenting
15782924|NCT04589949|Biological|ConvP|"Infusion of plasma retrieved from donors with a history of PCR proven symptomatic COVID.
~Plasma will be administered according to the Erasmus MC KIS protocol regarding the use of blood products"
15782925|NCT04589949|Biological|FFP|Infusion of thawed non-convalescent plasma Plasma will be administered according to the Erasmus Medical Center quality protocol regarding the use of blood products
15783127|NCT04588246|Other|Questionnaire Administration|Ancillary studies
15782927|NCT04589923|Device|Lifelight® Data Collect Blood Pressure Group|The staff member will prepare for and take the participant's routine observations using standard clinical equipment during the same 60-second period that video is captured of the participant's face using Lifelight® Data Collect (from which only the RGB data will be uploaded to the cloud). These measurements and RGB data capture will be repeated two times following the initial observations. Once measurements are concluded, the study staff member will complete the post-measurement observation questions.
15782928|NCT04589923|Device|Lifelight® Data Collect Oxygen Saturation Group|The staff member will prepare for and take the participant's routine observations using standard clinical equipment during the same 60-second period that video is captured of the participant's face using Lifelight® Data Collect (from which only the RGB data will be uploaded to the cloud). These measurements and RGB data capture will be repeated two times following the initial observations. Once measurements are concluded, the study staff member will complete the post-measurement observation questions.
15782929|NCT04589910|Diagnostic Test|diaphragm thickness and thickening fraction|Ultrasound measurement of the diaphragm will be performed with the use of a Sono Site SII, portable system in B mode with the child in a 30-degree supine position. The diaphragm thickness will be measured with a high frequency (4-10 MHz) linear array transducer placed in the ninth or tenth intercostal space between the anterior and midaxillary lines in the zone of apposition between lung and liver.
15782930|NCT04589897|Device|Manuka honey sinus rinse|Will follow a modified NHS nasal rinse protocol with the addition of manuka honey
15782931|NCT04589897|Device|Standard sinus rinse|will follow the standard NHS nasal rinse protocol
15782932|NCT04589884|Other|Hyperspectral Imaging|Hyperspectral images of the operative field will be collected at several time points during the surgical procedure. The device used is the TIVITA® compact Hyperspectral imaging system (Diaspective Vision GmbH, Germany). It is a CE (European Economic Area) mark approved device. The acquisition takes roughly 10 seconds, is contrast-free and contact-free.
15782933|NCT04589871|Other|Taping technique|Fixmull stretch and Leukotape (rigid tape) were used in taping to guide the patellar trajectory orientation while performing the movement. Individuals were asked to lay down in supine position with knee in a slightly bent position. Fixomull stretch was used as an adhesive pre-wrap to protect the skin and provide some of the checking force. The main check strap was provided by stripes of rigid tape (Leukotape). The knee cap was taped, started on the outer aspect of the knee cap and pulled inwards. Finished at the back of the inside of the knee. Two further pieces of tape (Fixomull Stretch and Leukotape) applied distal to the patella unloaded the infrapatellar fat pad.
15782934|NCT04589871|Other|A supervised exercise protocol|Quadriceps Strengthening; Terminal knee extension; Ball kicking; Strengthening of Vastus Medialis;
15782935|NCT04589858|Other|Supervised exercise protocol|Strengthening exercises:It included a sets/group of exercises such as a static quad set in knee extension, standing terminal knee extension, seated leg-press, partial squats weight-lessened with arm support as needed, and step-ups Stretching Exercises:A slow, sustained stretching was performed in different positions for different group of muscles with holding time 30-seconds, a gap of 1-minute between two repetitions, and repeated 3-times per session on alternate day for 2-weeks. The stretching performed for the calf muscle, hamstring muscle, and quadriceps femoris muscle in standing, supine, and prone positions respectively.
15782936|NCT04589858|Other|Specified Manual Therapies|"Myofascial Mobilization: Patellar glide performed in all available ROM and direction such as superior-inferior and lateral-medial translation/glides of patella over patellar fossa.
~Myofascial manipulation technique: Manipulation of knee joint. An impulse type thrust was delivered, directed in the caudal direction to mobilize the joint in a near-full extension position."
15782948|NCT04589832|Drug|Entrectinib|Pharmacokinetic and pharmacodynamic assay for entrectinib will be performed during Days 3 and 21 of Cycle 1. Entrectinib therapy will be withheld on Day 1 and Day 2 of Cycle 1, initiated on Day 3 of Cycle 1 and continue for the remainder of the 28 day cycle. For each successive cycle, entrectinib will be intiated on Day 1 and continue for 28 days of the 28-day cycle.
15782949|NCT04589819|Drug|Teriparatide|Teriparatide, an injectable synthetic parathyroid hormone, will be tested to evaluate its efficacy for decreasing the convalescence after a diaphyseal tibial stress fracture, a specific bone stress injury.
15782950|NCT04589819|Drug|Placebos|Placebo will be a sugar solution of the manufacturer's design.
15782951|NCT04589806|Procedure|2-stage ridge splitting|two-stage alveolar ridge splitting technique using piezoelectric device with simultaneous implant placement in order to treat narrow posterior mandibular ridges avoiding the risks of malfracture and necrosis of the split part
15782952|NCT04589793|Behavioral|Life Style|Life Style intervention including physical activity, diet, sleep and stress
15782953|NCT04589767|Behavioral|CAPD scale|Two nurses will apply CAPD scale. One nurse will repeat the CAPD evaluation two minutes later
15782954|NCT04589754|Drug|Sintilimab plus chemotherapy|AI regimen chemotherapy (ADM 50 mg / m2, D1 + IFO 2.5 g / m2, D1-3, IV drip) was used for 3 weeks; CAV / IE regimen alternate chemotherapy (regimen 1: CTX 1.2mg/m2 D1 + ADM 50mg / m2 D1 + VCR 1.4mg/m2 D1 and regimen 2: IFO 1.5g/m2 D1-5 + VP-16 100mg / m2 D1-5, IV drip). Regimen 1 and 2 were performed alternately, with a cycle of 3 weeks; sintilimab (10ml; 100mg) was administered intravenously every 3 weeks;
15782955|NCT04589741|Drug|Toripalimab Combined With CAV / IE Regimen chemotherapy|"CAV / IE regimen alternate chemotherapy (regimen 1: CTX 1.2mg/m2 D1 + ADM 50mg / m2 D1 + VCR 1.4mg/m2 D1 and scheme 2: IFO 1.5g/m2 D1-5 + vp-16 90mg / m2 D1-5, IV drip). Regimen 1 and 2 were performed alternately, with a cycle of 3 weeks;
~The patients were treated with toripalimab (240mg, 6ml) intravenously every 3 weeks;
~If doxorubicin has reached the upper limit or reduced cardiac toxicity, liposome adriamycin (50mg / m2) or IE regimen can be used
~After 6 courses of treatment, patients with disease control (CR + PR + SD) and tolerable adverse reactions were treated continuously. The study was completed when the researchers considered that the patients were not suitable for continuous medication or the efficacy evaluation was disease progression (PD). No other anti-tumor treatment can be carried out during the treatment."
15782956|NCT04589728|Drug|Venetoclax plus HMA|patients with AML, ineligible for intensive chemotherapy, treated with the combination of HMA plus venetoclax under the Italian Law N. 648/96.
15782957|NCT04589715|Other|electroacupuncture|the same as described in experimental arm.
15782958|NCT04589715|Other|sham electroacupuncture|the same as described in sham comparator.
15782959|NCT04589689|Behavioral|Insul-In This Together|Session 1: Introduction to Parental Monitoring Session 2: Advanced Parental Monitoring Session 3: Introduction to Parental Involvement Session 4: Advanced Parental Involvement Session 5: Introduction to Parent-Teen Conflict Management Session 6: Advanced Parent-Teen Conflict Management
15782960|NCT04589676|Behavioral|Community identity recruitment|Multiple communication channels will be used in targeted areas of Boone and Hancock counties to recruit citizen responders through messages that appeal to their communal identities (e.g., benefits as members of communities and other social groups).
15782961|NCT04589676|Behavioral|Personal identity recruitment|Multiple communication channels will be used in targeted areas of Boone and Hancock counties to recruit citizen responders through messages that appeal to their personal identities (e.g., benefits to them as individuals).
15782962|NCT04589676|Behavioral|Face-to-face training|Participants in the face-to-face training condition will receive training in groups of 20. Standardized content will teach them to use the PulsePoint app, respond safely to calls, and administer Naloxone.
15782963|NCT04589676|Behavioral|Online training|Participants in the online training condition will receive training in groups on Smartphones and other devices at their own pace. Standardized content will teach them to use the PulsePoint app, respond safely to calls, and administer Naloxone.
15782964|NCT04589663|Drug|Mometasone furoate|Single inhaled dose of 100 µg mometasone furoate (MF) administered via Twisthaler® on Day 1
15782965|NCT04589663|Drug|QMF149|Single inhaled dose of QMF149 (75/40 µg indacaterol acetate/MF fixed dose combination) administered via Concept 1 device on Day 6
15782968|NCT04589624|Drug|Hyperpolarized Carbon C 13 Pyruvate|Given IV
15782969|NCT04589624|Procedure|Magnetic Resonance Imaging|Undergo MRI
15782970|NCT04589624|Procedure|Magnetic Resonance Imaging|Undergo hpMRI
15782971|NCT04589611|Drug|amobarbital/Gel-One (one dose)|One dose of amobarbital/Gel-One during the initial surgical intervention
15782972|NCT04589611|Drug|Placebo (single dose)|One dose of placebo during the initial surgical intervention
15782973|NCT04589611|Drug|amobarbitol/Gel-One (two doses)|One dose of amobarbital/Gel-One during the initial surgical intervention. A second dose will be administered during the second surgical intervention.
15782974|NCT04589611|Drug|Placebo (two doses)|One dose of placebo during the initial surgical intervention. A second dose will be administered during the second surgical intervention.
15782975|NCT04589598|Device|Femoral Neck System|femoral neck system using bolt and antirotation screw with one/two hole plate
15782976|NCT04589598|Device|Multiple Cannulated Screw|multiple cannulated screw using 3 or 4 cannulated screw
15782977|NCT04589585|Device|DiVeRt|DiVeRt - Vascular Reconstruction Device and Delivery System
15782978|NCT04589572|Procedure|XLIF|the XLIF procedure, a minimally invasive procedure that approaches the spine from the lateral via the space between the 12th rib and the highest point of the iliac crest.
15782979|NCT04589572|Procedure|PLIF|open posterior lumbar interbody fusion (PLIF) or transforaminal lumbar interbody fusion (TLIF) are used to treat degenerative diseases of the spinal column.
15783014|NCT04589234|Drug|FOLFIRINOX Alone (Historical Controls)|We will use historical data from the literature to compare FOLFIRINOX alone against the FOLFIRINOX with Salmonella-IL2 group
15782980|NCT04589559|Behavioral|Heart Rate Variability Biofeedback Training|First, participants are taught how to do relaxed, abdominal breathing. Second, they are taught how to breathe at a slow rate of 0.1 Hz (i.e., one completed breath cycle every 10 seconds). Third, they are taught how to monitor their heart rate variability (HRV) in real time using the smartphone app, which receives data wirelessly via Bluetooth from the heart rate monitor. Participants are instructed that their goal is to increase their HRV during the three weeks of at-home practice.
15782981|NCT04589546|Drug|Nicotinamide treatment|Nicotinamide (500 mg) will be mixed in 50 ml of 0.9% saline and administered intravenously every 12 h for a total of 72 h.
15782982|NCT04589546|Drug|placebo treatment|For the placebo group, an identical volume of 0.9% saline will be administered in the same manner.
15782983|NCT04589533|Other|educational program|The educational program will be based on: a outreach visit (a 3-h face-to-face meeting between a trained diabetes specialist from outside the Center and the staff of the Center itself) and a distance learning (FAD).The educational programme will be focused on current Diabetes Guidelines recommendations and based on possible deviations from the best clinical practice observed during phase1
15782984|NCT04589520|Behavioral|HeartBot App|HeartBot is an app designed to enable people 14 years and older to use relaxation tools offered by Heartfulness to deal with daily stress and anxiety in a healthy, productive manner.
15782985|NCT04589494|Drug|Tramadol Hydrochloride|tramadol hydrochloride 100 mg three times daily , morphine sulphate 30 mg twice daily
15782986|NCT04589481|Other|Intake of 3 different candies against bad breath|Intake of 3 different candies against bad breath on three different days (2-days interval each) after artificially creating a temporary bad breath (by eating of chips and cheese); analysis of breathing during intake of candy both subjectively and objectively
15782987|NCT04589468|Other|Exercise|Exercise therapy in both phases will consist of individualized walking delivered 3 to 6 times weekly (over a 7-day period). Exercise treatment will be delivered for up to 18 months, or until progression of disease or withdrawal of consent, whichever comes first. The phase 1a trial will assess five doses of exercise therapy (i.e., 90, 150, 225, 300, and 375 mins/wk) delivered following a non-linear (i.e., exercise dose is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule. The phase 1b trial will only test one dose of exercise therapy - the RP2D identified in the phase 1a trial.
15782988|NCT04589455|Dietary Supplement|Hennep extract|Hennep extract from Becanex containing 70 mg CBD
15782989|NCT04589442|Biological|Split thickness skin graft|standard of care graft
15782990|NCT04589442|Biological|microsurfaced split thickness skin graft|standard of care graft that has been microsurfaced
15782991|NCT04589429|Drug|Morphine 10 MG/ML|intrathecal morphine 300 micrograms
15782992|NCT04589429|Drug|Nalbuphine Hydrochloride 10 MG/ML|intrathecal nalbuphine 2mg.
15782993|NCT04589416|Other|Dental adhesive materials.|It is used to bond the composite resin to the dental tissues. That is, it is used to bond dental filling materials to dental tissues.
15782994|NCT04589403|Drug|OPT101|15-mer peptide with sequence based on the mouse CD154 domain interacting with CD40
15782995|NCT04589390|Drug|Selexipag|treatment with selexipag
15782996|NCT04589377|Behavioral|Mindfulness Training|Training is focused on learning the principle of RAIN (recognize, accept, investigate, non-identify) in the context of physics learning.
15782997|NCT04589364|Drug|Injection botulinum toxin A ( Dysport 100 unit or Neuronox 33.33 unit)|injection of toxin on facial muscle
15782998|NCT04589351|Drug|Ezetimibe 10mg|Ezetimibe is a cholesterol absorption inhibitor with marketing approval. The recommended dose as per label is 10mg once a day.
15782999|NCT04589351|Drug|Placebo|Matching placebo
15783000|NCT04589338|Other|Endurance training|This group will perform aerobic type exercises. Initially, patients will perform continuous exercises of progressive intensity in order to adapt to this kind of effort. Next, we will introduce interval exercises.
15783001|NCT04589338|Other|Resistance training|Patients in this group will perform lower limb strengthening exercises to improve the maximum strength of different muscle groups.
15783002|NCT04589325|Drug|Ixekizumab|"Ixekizumab will be available at a concentration of 80 mg solution for injection in pre-filled syringes.
~Ixekizumab will be administrated by the patient via subcutaneous (s.c.) injections for a total treatment period of 12 months. Two s.c. injections (160 mg) will be administrated at week 0, one dose (80 mg) at week 2, 4, 6, 8, 10 and 12 and continue with a maintenance dose (80 mg) every 4th week for a total treatment period of 12 months."
15783003|NCT04589325|Drug|Placebo|"Placebo will be available at a concentration of 80 mg solution for injection in pre-filled syringes.
~Placebo will be administrated by the patient via subcutaneous (s.c.) injections for a total treatment period of 12 months. Two s.c. injections (160 mg) will be administrated at week 0, one dose (80 mg) at week 2, 4, 6, 8, 10 and 12 and continue with a maintenance dose (80 mg) every 4th week for a total treatment period of 12 months."
15783004|NCT04589312|Biological|Standard of care vaccines|Visit 1: Check tetanus immunisation status. Vaccination up to 25+ 6 weeks of pregnancy with Td; Visit 2: vaccination at least 4 weeks after visit 2 with either Tdap or Td (per randomisation and according to WHO guidance)
15783005|NCT04589312|Biological|Boostagen, (BioNet-Asia)|Visit 1: Check tetanus immunisation status. Vaccination up to 25+ 6 weeks of pregnancy with Td; Visit 2: vaccination at least 4 weeks after visit 2 with either Tdap or Td (per randomisation and according to WHO guidance);
15783006|NCT04589299|Biological|Immunoglobulin|Randomization 1:1 to the same total dose of either SCIG or IVIG for 26 weeks of stable dose + 60 weeks of redcution.
15783007|NCT04589286|Behavioral|Pack Health's Digital Life Coaching (DLC)|Pack Health smartphone-based DLC platform
15783008|NCT04589286|Other|Electronic Handouts|Generic wellness-related electronic handouts
15783009|NCT04589273|Dietary Supplement|Alginate|Volunteers will be asked to consume the alginate capsules with each of their three main meals per day.
15783010|NCT04589273|Other|Placebo|Volunteers will be asked to consume the placebo capsules with each of their three main meals per day.
15783011|NCT04589260|Drug|TD-1058|Study drug to be administered by oral inhalation
15783012|NCT04589260|Drug|Placebo|Placebo to be administered by oral inhalation
15783013|NCT04589234|Drug|Salmonella-IL2|Phase 2 study to determine the anti-tumor effectiveness of Salmonella-IL2 (Saltikva) with standard of care chemotherapy (either FOLFIRINOX or Gemcitabine/Abraxane) for metastatic pancreatic cancer
15783015|NCT04589234|Drug|Gemcitabine/Abraxane Alone (Historical Controls)|We will use historical data from the literature to compare Gemcitabine/Abraxane alone against the Gemcitabine/Abraxane with Salmonella-IL2 group
15783016|NCT04589221|Behavioral|Ad libitum energy intake|Investigate ad libitum energy intake according to degree of food processing and eating behaviour
15783017|NCT04589208|Drug|Ketamine Hydrochloride|We will assign ketamine doses in successive 10 subject cohorts. The ketamine dose for the 1st cohort will start at 0.08 mg/kg. For subsequent cohorts, the bolus will be successively reduced or increased by 0.02 mg/kg (n=10/dose) to determine the lowest dose of ketamine that still produces a robust phBOLD response
15783019|NCT04589182|Device|MHSL- SleepBand|The MHSL-SleepBand (sleep headband) is easy to apply and only involves attachment of sticky electrodes on different locations on the face/behind ear to be able to measure EEG (electroencephalogram), EOG (electrooculogram) and EMG (electromyogram). Brief tones at a low volume (around 60 dB, comparable to conversation) will be applied, when slow waves are present in the course of the sleep period and other criteria are fulfilled. Auditory stimulation will start with a specific volume that has been adjusted to the individual hearing capacity (usually between 45-65 dB; maximum 80 dB). The stimulation is performed in a way that the general structure of sleep (e.g. duration, sleep cycling, etc.) is unchanged.
15783020|NCT04589182|Device|Sham|Playing no tones during non- Rapid Eye Movement (NREM) sleep but wearing the device and recording the biosignals over a period of 3 nights, every night.
15783021|NCT04589143|Drug|Agomelatine|Oral tablets of agomelatine at a dose of 25-50 mg/d for 8 weeks
15783022|NCT04589143|Drug|Placebos|Oral tablets of placebos at a dose of 25-50 mg/d for 8 weeks
15783023|NCT04589130|Drug|Contrave 8Mg-90Mg Extended-Release Tablet|"Each Contrave Extended Release Tablet contains 8Mg of naltrexone HCl and 90Mg of bupropion HCl and will be administered orally. Total daily dose is 32Mg / 360Mg.
~Participants randomized to the treatment arm will be administered 4 Contrave tablets a day for 1 year (2 tablets taken twice a day).
~Participants randomized to the control arm for the first 6 months will crossover and be administered 4 Contrave tablets a day during the second 6 months (2 tablets taken twice a day). All participants will be in the treatment group (Contrave) during the second 6 month phase of the study."
15783024|NCT04589130|Drug|Placebo|Placebo tablets will be administered orally. Participants randomized to the control arm will be administered 4 placebo tablets a day (2 tablets, taken twice a day) during the first 6 months of the study. These participants will crossover to treatment with Contrave for the second 6 months of the study.
15783025|NCT04589117|Behavioral|Expressive writing|"The 4-week study intervention will invite participants through a progression of expressive writing exercises designed to support emotional expression and enhance personal resilience. Weekly instruction writing sessions will be conducted via Zoom. The sessions will not be recorded, but participants who cannot attend the sessions live (or prefer not to, for any reason) will receive each week's instructions and prompts via email.
~The progression of writing exercises flows as follows:
~Week 1: Writing to expressive difficult emotions
~Week 2: Writing to cultivate compassion & forgiveness
~Week 3: Writing to nurture positive emotions
~Week 4: Writing to invite insight, perspective, & growth"
15783026|NCT04589104|Behavioral|Expressive writing|"The expressive writing intervention consists of a 6-week, virtually-delivered writing program. Each week, participants meet for 90 minutes via Zoom and will be guided through writing prompts designed to encourage emotional expression and enhance personal resilience. The progression of writing exercises flows as follows:
~Week 1: Writing to expressive difficult emotions
~Week 2: Writing to release & integrate difficult emotions
~Week 3: Writing to nurture gratitude
~Week 4: Writing to enhance strengths & resources
~Week 5: Writing to cultivate positive meaning & savor goodness
~Week 6: Writing to invite insight, perspective, & growth"
15783027|NCT04589091|Other|Refractive surgery|Refractive surgery for correction of error of refraction
15783028|NCT04589078|Device|GI Genius CADe system|Each patient will undergo standard white-light colonoscopy with the support of the latest version of the CE marked GI Genius CADe available.
15783029|NCT04589065|Device|Selective Cytopheretic Device|SCD therapy will take place for 4 hours on day 1, 3, and 5 while on hemodialysis treatment. Participants will be continue to be followed until 30 days after the last SCD treatment.
15783030|NCT04589026|Drug|Cosentyx|Cosentyx injection will be administered subcutaneously.
15783031|NCT04589026|Drug|Candin|Candin will be administered interadermally along with NaCl solution.
15783032|NCT04589000|Other|acupressure|"Throughout the study, acupressure will be applied to the acupressure group once on the post-op day 0, 2 times on the post-op 1st day, and once on the post-op 2nd day, 4 times in total for 15 minutes.
~15 minutes after acupressure application, milk will be expressed for 15 minutes and the amount of milk expressed will be recorded in the milk measurement table."
15783033|NCT04588987|Biological|PD-1|Neoadjuvant PD-1 and Apatinib for rHGG. Adjuvant PD-1 and Apatinib for rHGG
15783034|NCT04588974|Device|magnetic-assisted capsule endoscope system (InsightEyes EGD System) with or without 3D images|The patient will undergo both diagnostic tests within two days, a magnetic-assisted capsule endoscope system first and then conventional EGD will be carried on at least 4 hours afterward.
15783035|NCT04588961|Procedure|Trapeziectomy with suspensionplasty|Surgical removal of trapezium bone and ligamentoplasty of first metacarpal bone using abductor pollicis tendon
15783036|NCT04588961|Procedure|Joint alloplasty|Surgical removal of degenerated joint surfaces nad replacement using modern designed prothesis
15783037|NCT04588948|Drug|Intravitreal Aflibercept|Two arms (non-vitrectomized, and vitrectomized) are included in the study to evaluate the effect of vitrectomy on the intraocular and systemic pharmacokinetics of intravitreal aflibercept injection
15783038|NCT04588935|Drug|Bisoprolol; Perindopril;|based on the results of the patient study, different drug therapy regimens for cardiovascular complications during chemotherapy will be proposed
15783039|NCT04588922|Drug|GFH009|In the dose escalation part, the dose levels will be escalated following the Bayesian optimal interval (BOIN) design. In the expansion part, patients will be assigned based on tumor type(s).
15783040|NCT04588909|Procedure|Colorectal resections|All patients admitted with colorectal cancer were subjected to various types of colorectal resections
15783041|NCT04588896|Device|Continuous glucose monitoring|Abbott Freestyle Libre CGM for 8 weeks in adjunct to lifestyle modification programme
15783043|NCT04588883|Behavioral|Kuja Pamoja - HIV|Information has been provided in the treatment arm description.
15783044|NCT04588870|Device|Pre operative computer based cochlear implant surgical simulation|Prior to surgery, the surgeon will perform virtual cochlear implant surgery on patient specific imaging data within a computer simulation program. The surgeon will be able to iterate the procedure on the simulator until achieving the best electrode array location is achieved with respect to scalar location and modiolar distance. A written and graphical surgical plan will then be developed that the surgeon can use in the actual surgery.
15783045|NCT04588857|Drug|Dexamethasone|The participants in the experimental group will receive a single 24 mg intravenous dose of dexamethasone immediately prior to PAE.
15783046|NCT04588857|Drug|Saline|The participants in the placebo group will receive 6 ml of saline i.v. immediately prior to PAE.
15783047|NCT04588844|Drug|Polyethylene Glycol Recombinant Human Somatropin|Polyethylene glycol recombinant human somatropin will be injected weekly (3mg/per week) from the beginning of preceding menstruation cycle until the day of ovum pickup.
15783048|NCT04588831|Device|Mouthguard|Protective device for orofacial complex for patients playing contact sports
15783049|NCT04588818|Drug|Adalimumab plus Methotrexate|"Adalimumab 40 mg (≥30kg weight) or 20mg (<30kg weight) subcutaneously every other week without loading dose.
~Methotrexate(10 to 20 mg per square meter of body-surface area; maximum dose, 20 mg) ."
15783050|NCT04588792|Drug|Nebulized Furosemide|Furosemide administered by nebulization through the ventilator circuit
15783051|NCT04588792|Drug|Nebulized Saline|Saline administered by nebulization through the ventilator circuit
15783052|NCT04588779|Other|Graston|"Ultrasound for 10 mins/1 set/ (3 sessions/week), Graston for 5 mins/1 set/ (3 sessions/week), Piriformis stretching exercises/ 10 reps with 30 sec hold/ 1 set/(3 sessions/week), Hip abductor strengthening/10 reps/1 set/(3 weeks), Hip extensor strengthening/10 reps/1 set/(3 weeks),
~A total of 9 sessions for 3 weeks (3 sessions/week) were given each consisting of 20 mins."
15783053|NCT04588779|Other|Manual myofascial release|"Ultrasound for 10 mins/1 set/ (3 sessions/week), Manual myofascial release for 5 mins/1 set/ (3 sessions/week), Piriformis stretching exercises/ 10 reps with 30 sec hold/ 1 set/(3 sessions/week), Hip abductor strengthening/10 reps/1 set/(3 weeks), Hip extensor strengthening/10 reps/1 set/(3 weeks),
~A total of 9 sessions for 3 weeks (3 sessions/week) were given each consisting of 20 mins."
15783054|NCT04588766|Other|constipation group|Constipation symptoms of individuals with cerebral palsy who were randomly evaluated were questioned and recorded according to Rome IV criteria. The group with cerebral palsy constipation was included in this group.
15783055|NCT04588766|Other|control group|Constipation symptoms of individuals with cerebral palsy who were evaluated randomly were questioned and recorded according to Rome IV criteria. The group with cerebral palsy without constipation was included in this group.
15783056|NCT04588753|Other|active isolated stretch|"Active Isolated Stretch (AIS);
~The shortened hamstring muscle will be isolated.
~The hamstring will be stretched.
~This Stretches will be Repeated eight to 10 times.
~Stretch will be hold for no more than two seconds.
~Exhale on the stretch; inhale on the release. Other amputees training exercises;
~weight-shifting
~Dynamic balancing activities
~Stool stepping
~Braiding
~Gait exercises
~Climbing/descending the stairs"
15783057|NCT04588753|Other|Post Facilitation Stretch|"Participants of this group will receive Post Facilitation Stretch (PFS);
~The shortened hamstring muscle will be placed between a fully stretched and a fully relaxed state.
~The patient will be asked to contract the hamstring using a maximum degree of effort for 5-10 seconds while the therapist will resists thepatients force.
~The patient will be then asked to relax and release the effort, whereas the therapist will apply a rapid stretch to a new barrier and is held for 10 seconds.
~The patient relaxes for approximately 20 seconds and the procedure will be repeated to five times (8) (18).
~2. Other amputees training exercises;
~weight-shifting
~Dynamic balancing activities
~Stool stepping
~Braiding
~Gait exercises
~Climbing/descending the stairs"
15783058|NCT04588740|Drug|concentrated beet root juice|On average, we will expect subjects to ingest the supplement for approximately 5 days minimum depending on their testing schedule. On each testing day subjects will be asked to consume the two bottles of either beetroot juice (BRJ) or Placebo 2.5 hours before testing time. Specifically, for female subjects, they will be asked to start their supplementation on day 1 of menses. On day 3-4 they will take the last 2 shots. Female subjects' wash-out period will go according to their menstrual cycle as we will be controlling for hormone fluctuation (low vs high estrogen phase) know to interact with nitric oxide physiology.
15783059|NCT04588740|Drug|Placebo beet root juice|This will follow the same supplementation regime as explained above but this supplement taste and looks exactly the same as the nitrate-rich beet root juice. It is provided by the same company that produces the concentrated beet root juice shots (Beet It, UK)
15783060|NCT04588727|Drug|AZD3366|In Part A, subjects will be randomized to receive intravenous infusion AZD3366 dose 1-7, single ascending dose (SAD). In Part A, Dose 2-7 may be adjusted based on PK data from previous cohort[s]. In Part B, subjects will be randomized to receive intravenous infusion AZD3366 dose X (a dose resulting in predicted therapeutic exposure).
15783061|NCT04588727|Drug|Placebo|In Part A and Part B, subjects will be randomized to receive intravenous infusion of placebo (0.9% sodium chloride solution).
15783062|NCT04588727|Drug|Ticagrelor|In Part B, subjects will receive oral ticagrelor tablets.
15783063|NCT04588727|Drug|acetylsalicylic acid (ASA)|In Part B, subjects will receive oral ASA chewable tablets.
15783064|NCT04588714|Behavioral|Resilience-based, Energy Management to Enhance Wellbeing (RENEW)|The program includes unlimited website access and 10 scheduled phone calls with an assigned peer mentor.
15783065|NCT04588701|Procedure|surgical procedures commonly done for anal fistula|Surgical procedures performed, including fistulotomy; fistulotomy with sphincter repair; seton; advancement flap; fistula plug;
15783066|NCT04588688|Drug|Mifepristone|Mifepristone is a selective antagonist of the progesterone receptor at low doses and blocks the glucocorticoid receptor (GR-II) at higher doses. Mifepristone has high affinity for the GR-II receptor but little affinity for the GR-I (MR, mineralocorticoid) receptor.
15783067|NCT04588675|Diagnostic Test|MRI|the patients will underwent dobutamine stress cardiac MRI
15783068|NCT04588649|Drug|THK-5351|[18F]THK-5351 PET Imaging
15783069|NCT04588649|Drug|AV-45|[18F]AV-45 PET Imaging
15783128|NCT04588246|Radiation|Stereotactic Radiosurgery|Undergo salvage SRS
15783129|NCT04588246|Radiation|Whole-Brain Radiotherapy|Undergo HA-WBRT
15783070|NCT04588636|Behavioral|behavioral and self-care therapy|It is based on the premise that cognition, the process of acquiring knowledge and forming beliefs, is a primary determinant of mood and behavior. The therapy uses behavioral and self-care techniques to identify, correct and prevent behaviors or situations capable of altering the subject's state
15783071|NCT04588636|Device|rigid occlusal splint (ROS)|Occlusal splint formed in a vacuum from rigid individual sheets of 2 mm thick polyethylene terephthalate (Biolon, Dreve, Unna, Germany).
15783072|NCT04588636|Device|soft occlusal splint (SOS)|Occlusal splint formed in a vacuum from 3 mm thick individual soft sheets of ethyl vinyl acetate (Drufosoft, Dreve, Unna, Germany).
15783073|NCT04588636|Device|non-occlusive splint (NOS)|non-occlusive splint formed under vacuum from individual sheets of rigid polyethylene terephthalate 2 mm thick (Biolon, Dreve, Unna, Germany), from which the occlusal surfaces were cut and incisal edges, allowing the usual occlusal contact of each subject.
15783074|NCT04588623|Dietary Supplement|Omnibiotic Stress Repair (OBSR)|OBSR is given orally once daily (3g) for 3 months
15783075|NCT04588623|Other|Placebo|Placebo is given orally once daily (3g) for 3 months
15783076|NCT04588584|Other|Survey and Interviews|Survey and Interviews
15783077|NCT04588571|Procedure|Endovascular recanalization with angioplasty and stenting with the biomimetic interwoven nitinol stent|"Under local anesthesia, a standard endovascular approach is performed and the affected arterial segment is visualized. Transluminal or subintimal recanalization of the occluded arterial segment is performed with a hydrophilic guidewire. Next, balloon angioplasty of the recanalized segment is performed. After control angiography, a biomimetic interwoven nitinol stent is placed throughout the lesion.
~Drug therapy includes pre-procedure aspirin (160-300 mg/day), starting at least one day before, and intra-procedure heparin (100 U / kg body weight intravenously). After the procedure, all patients have prescribed aspirin (100 mg per day) for a long time and clopidogrel (75 mg per day) for 3 months."
15783078|NCT04588571|Procedure|Femoropopliteal proximal bypass|"Under general anesthesia, 2 standard open surgical approaches are performed: first - to the common femoral artery, superficial femoral artery, and deep femoral artery; the second - to the first portion of the popliteal artery. After systemic heparinization, clamps are applied to the arteries. A longitudinal arteriotomy of the popliteal artery is performed, and a distal end-to-side anastomosis is formed between the artery and the shunt. Next, the shunt is passed into the groin wound. Longitudinal arteriotomy of the common femoral artery. A proximal end-to-side anastomosis is formed between the shunt and the common femoral artery. Surgical hemostasis wound drainage and layer-by-layer wound closure are performed.
~Drug therapy includes pre-procedure aspirin (160-300 mg/day), starting at least one day before, and intra-procedure heparin (100 U / kg body weight intravenously). After the procedure, all patients have prescribed aspirin (75-100 mg per day) for a long time."
15783079|NCT04588558|Device|Flywheel exercise|Flywheel training is a strength training modality that offers the possibility of performing exercises with eccentric overload and variable resistance as compared to conventional gravity-based resistance training. Flywheel exercise applied three days a week for 8 weeks
15783080|NCT04588558|Other|Home exercise|The active ROM exercise was performed via knee in extension to full-flexion, then knee in flexion to full-extension exercises, repeated 10 times. The strengthening exercises consisted of quadriceps strengthening by holding maximal isometric contractions for 10 s and performing 10 repetitions. Stretching targeted the gastrocnemius- soleus and hamstring muscle and was performed by asking the patient to stretch the muscle for 30 s and to complete three repetitions for each muscle group.
15783081|NCT04588558|Device|Electrotherapy group|"The participants in the electrotherapy group received TENS (Intellect; Chattanooga Group, Hixson, TN), therapeutic ultrasound (Intellect 340 Combo) and exercise. TENS was applied via four electrodes around the knee joint: two on the medial and two on the lateral aspect on either side of the joint line for approximately 20 min. For pain relief, the devices were set to a continuous mode (110 Hz, 50 μ). Electrical pulses were asymmetric and biphasic.
~Therapeutic pulsed ultrasound therapy was administered using a 1-MHz frequency, 0.8 W/cm power ultrasound device with a sound-head area of 5 cm2 and effective radiating area of 3.5-5 cm2 . Ultrasound was applied to the medial and lateral parts of the knee in circular movements for a duration of 5 min with the patient in a supine position.
~All participants received the same standardized exercise program. The exercises included aerobic, active ROM, strength, and stretching exercises"
15783082|NCT04588545|Radiation|Radiation Therapy|Participants will receive radiation therapy (RT), either whole brain radiation therapy or focal brain/spine RT. The goal of RT is to palliate symptoms and improve the flow of Intrathecal (IT) therapy through the cerebrospinal fluid (CSF). As such, various RT schedules and targets are permitted. It is expected that the majority of patients will receive WBRT with 30 Gy in 10 fractions. However, shorter fractions of 20 Gy in 5 fractions of WBRT are permitted. In those patients who have more localized leptomeningeal disease in the spine, focal RT in up to 10 fractions may be administered with the exact dose left up to the discretion of the treating radiation oncologist.
15783083|NCT04588545|Drug|Pertuzumab|Participants will be treated at 1 of 4 dose levels of pertuzumab, beginning at 10 mg and increasing up to 80 mg or Maximum Tolerated Dose (MTD).
15783084|NCT04588545|Drug|Trastuzumab|Participants will be treated at a fixed dose of 80 mg trastuzumab.
15783085|NCT04588532|Drug|BAM8-22|Bovine Adrenal Medulla will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)
15783086|NCT04588532|Drug|Histamine|histamine will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)
15783087|NCT04588532|Drug|Cowhage (Mucuna Pruriens)|cowhage spicules will be applied to 2 previously determined area on the volar forearm (one alone and one in combination with doxepin)
15783088|NCT04588532|Drug|Doxepin|Doxepin cream (antihistamine) will be applied in 4 areas on the volar forearm
15783089|NCT04588519|Device|Spark Biomedical Roo Transcutaneous Auricular Neurostimulation (tAN) System|Spark Roo tAN System programmed to a pulse width of 250ms; channel 1: 5 Hz, mean intensity 0.3±0.2 mA; channel 2: 100 Hz, mean intensity 0.6±0.2 mA.
15783090|NCT04588506|Procedure|Lower Trapezius Tendon Transfer Technique|Lower Trapezius tendon used in repairing cuff tear
15783091|NCT04588506|Procedure|Latissimus Dorsi Tendon Transfer Technique|Latissimus Dorsi tendon used in repairing cuff tear
15783092|NCT04588506|Procedure|Pectoralis Tendon Transfer Technique|Pectoralis tendon used in repairing cuff tear
15783258|NCT04587271|Dietary Supplement|Placebo|Mothers and children will receive porridge with placebo.
15783093|NCT04588493|Diagnostic Test|Lower extremity Lymphoscintigraphy|Study of lymphoscintigraphy (LCG) abnormalities in a group of patients with history of infiltration of modeling substances in buttocks and hips and complain about lower extremities edema. LCG was performed and evaluated by a single nuclear medicine specialist through injection of the sulfur nanocolloid Technetium 99m, injected intradermal and interdigital in bilateral toes. Dynamic studies were requested for all patients. Standardized acquisition times at 15, 30, 60 and 120 minutes after injection were taken. The following parameters were considered to obtain the transport index in each pelvic limb: transport kinematics, distribution pattern, index time for the appearance of regional lymph nodes, number and collection of colloids in lymph nodes and presence and quality of the colloid uptake by the lymphatic vessels. Summation of these five components resulted in the transport index, which could range from 0 to 45 points
15783094|NCT04588480|Biological|BNT162b2|BNT162b2 (intramuscular injection)
15783095|NCT04588480|Other|Placebo|Placebo (intramuscular injection)
15783096|NCT04588467|Other|Medical treatment|Pregnant women complaining thrombosed haemorrhoids will receive dietary modification (intake of at lest 3 liers of water), stool-softeners (a 25 ml solution containing: Macrogol 3350: 13.125 g Sodium chloride: 0.3508 g Sodium hydrogen carbonate: 0.1786 g Potassium chloride: 0.0502 g) and local anesthetics application
15783097|NCT04588467|Procedure|Surgical treatment|Pregnant women complaining thrombosed haemorrhoids will receive local excision or thrombectomy under local anesthesia
15783098|NCT04588454|Other|18F-PSMA-1007 PET tracer|18F-PSMA-1007 PET/CT
15783099|NCT04588441|Drug|Adenosine|Adenosine will be given like an inhaled asthma medication two times daily for one week (7 days). Treatment consists of 9 mg adenosine in 5ml normal saline (NS) administered over 5-10 min via an Aerogen™ nebulizer.
15783103|NCT04588415|Other|Bereavement Virtual Support Group|"Family members who experience loss will be invited to attend a virtual support group (VSG) led by Bereaved Families of Ontario- Ottawa (BFO). In pre-COVID-19 times, BFO presented monthly Support and Share nights with guest speakers, followed by breakout peer support groups for all different types of losses: loss of child, spouse, parent, loss by suicide, etc. These groups are facilitated by trained volunteers with a shared loss and include between 75 and 150 participants. These Support and Share Nights serve as intake sessions- interested participants from the breakout groups can attend Closed Groups where a smaller group of participants (up to 12) explore their grief more deeply. These run over 8-10 consecutive weeks with the same group of participants. They are led by trained facilitators who have experienced similar losses. Each week has a different theme, based on evidence-based components of bereavement support (e.g. writing a letter to the deceased)."
15783104|NCT04588402|Biological|The study being observational in nature, there is no intervention. The investigators will only collect cervical samples from married women within a specified age range at different intervals.|"Women will be approached one time only, when they will attend the gynecology out-patients department for various reasons. After signing the informed consent, the participants will fill in a risk factor questionnaire to study the socio-demographic information, sexual history and HPV vaccination history and the determinent of HPV infection. The questionnaire will be administered by a trained social worker or nurse.
~A gynecologist will collect cervical cells from the participant's cervix during a gynecological examination. The cervical specimen will be examined for presence of specific HPV genotypes and Chlamydia infection."
15783105|NCT04588389|Drug|Ropivacaine injection Location 1|Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 1
15783106|NCT04588389|Drug|Ropivacaine injection Location 2|Ropivacaine .5% and lidocaine 1% to the area behind the muscle Quadratus Lumborum location 2
15783107|NCT04588389|Drug|Multimodal Pharmacological Management|standard of care multimodal pharmacological management
15783108|NCT04588376|Behavioral|Peer comparison feedback monthly|Monthly emailed data on performance for guideline-concordant use of antibiotics for three acute upper respiratory tract infections either at the clinician and clinic levels or at the clinic level only
15783109|NCT04588363|Other|SARS-CoV-2 and/or MIS-C Exposure|This is an observational cohort study.
15783110|NCT04588350|Device|i-SEP autotransfusion system|Intraoperative recovery and washing of the processed blood by i-SEP autotransfusion system in surgeries where a bleeding is expected
15783111|NCT04588337|Drug|rhTNK-tPA|Thrombolysis
15783112|NCT04588324|Drug|SHR2150|Patients will receive escalating doses of SHR-2150 (starting dose 2 mg) in 3-week treatment cycles.
15783113|NCT04588324|Drug|Anti-Cancer Agent|The previously resistant first-line cytotoxic regimens, anti-PD-1 antibody and/or anti-CD47 antibody will be administered intravenously Q3W.
15783114|NCT04588324|Drug|SHR2150|Patients will receive SHR-2150 at RP2D in 3-week treatment cycles.
15783115|NCT04588311|Drug|Epoetin Alfa 40000 UNT/ML|Epoetin alfa 40,000IU 1mL pre-filled syringe given as subcutaneous injection.
15783116|NCT04588311|Drug|Sodium Chloride 0.9%|Sodium Chloride 0.9% 1mL in volume given as subcutaneous injection.
15783119|NCT04588285|Drug|Ambroxol|Oral ambroxol medication (60 mg) from day 1 to study end (at 60 mg TID (day 1-7), 120 mg TID (day 8- 14), 315 mg BID (day 15-21), 315 mg TID (day 22-28) and 420 mg TID (day 29-550)
15783120|NCT04588285|Drug|Placebo|Oral placebo medication (60 mg) from day 1 to study end (at 60 mg TID (day 1-7), 120 mg TID (day 8- 14), 315 mg BID (day 15-21), 315 mg TID (day 22-28) and 420 mg TID (day 29-550)
15783121|NCT04588272|Device|DualGuard|DualGuard device (FlexiCare) which incorporate an endoscopy bite block with oxygen delivery and CO2 monitoring from both the mouth and nose simultaneously.
15783122|NCT04588259|Drug|Faster aspart|Administered s.c. (subcutaneously, under the skin) for 16 weeks
15783123|NCT04588259|Drug|Insulin aspart|Administered s.c. (subcutaneously, under the skin) for 16 weeks
15783124|NCT04588259|Drug|Insulin degludec|Administered s.c. (subcutaneously, under the skin) for 16 weeks
15783125|NCT04588246|Drug|Memantine|Given PO
15783126|NCT04588246|Other|Quality-of-Life Assessment|Ancillary studies
15783130|NCT04588233|Dietary Supplement|Melatonin|Each subject will receive 3mg of melatonin 1 hour prior to bedtime for 12 consecutive nights
15783131|NCT04588233|Other|Placebo|Each subject will receive a placebo 1 hour prior to bedtime for 12 consecutive nights
15783132|NCT04588220|Other|Obstetric ultrasound and fetal-maternal assessment|melatonin, soluble urokinase-type plasminogen activator receptor, and orosomucoid 2 measurements
15783133|NCT04588207|Drug|Urea|"Groups On Urea, Then Off Urea and Off Urea, Then On Urea will receive urea during period 1 and period 2 of the study, respectively. The investigators will use the new American formulation of oral urea (i.e., Ure-Na™), which is packaged as a powder and mixed with 4 ounces. of water for oral consumption. Urea will be started at a dose of 15 grams of urea per mouth once daily. Dose titration will be based on the absolute increase in PNa on days 2, 4, and 14. The urea dosing scheme will involve increasing from the starting dose of 15 grams/day to 30 grams/day (in 2 divided doses) based on the change in and absolute value of PNa, and subsequently, from 30 grams/day to 60 grams/day (in 2 divided doses) when indicated. The maximal dose of urea administered will be 60 g/day."
15783134|NCT04588194|Drug|Romiplostim|Romiplostim 2mcg/Kg subcutaneously weekly days 1, 7, 14, 21
15783135|NCT04588194|Drug|Rituximab|Rituximab 100 mg weekly days 1, 7, 14, 21
15783136|NCT04588194|Drug|Dexamethasone|40 mg IV/PO days 1-4
15783137|NCT04588181|Behavioral|cognitive behavioral therapy (CBT)|Cognitive behavioral therapy (CBT) is a psycho-social intervention that aims to improve mental health. CBT focuses on challenging and changing unhelpful cognitive distortions (e.g. thoughts, beliefs, and attitudes) and behaviors, improving emotional regulation, and the development of personal coping strategies that target solving current problems.
15783138|NCT04588168|Drug|Chemotherapy|Patients with muscle invasive bladder cancer will receive modified gemcitabine-cisplatin neoadjuvant chemotherapy prior to radical cystectomy for a period of two months (three 21 day cycles) as part of standard clinical routine.
15783139|NCT04588168|Diagnostic Test|Immediate Multiparametric MRI|Within 24 hours after the use of cisplatin during the first course of modified GC neoadjuvant chemotherapy, patient considered muscle invasive bladder cancer with baseline mpMRI will receive an immediate mpMRI scan.
15783140|NCT04588168|Procedure|Cystectomy and Lymphadenectomy|The patient with muscle invasive bladder cancer will undergo radical cystectomy and pelvic lymph node dissection followed by a urinary tract reconstruction.
15783141|NCT04588168|Diagnostic Test|conventional Multiparametric MRI|After two and three course of neoadjuvant chemotherapy, patient considered muscle invasive bladder cancer with baseline mpMRI will receive a conventional mpMRI scan.
15783142|NCT04588168|Diagnostic Test|Baseline Multiparametric MRI|Patient considered muscle invasive bladder cancer will receive a baseline mpMRI scan within one week before neoadjuvant chemotherapy.
15783143|NCT04588155|Device|Functional assessment|Timed Up and Go Test administration with application of Inertial Measurement Unit for a temporal and kinematic assessment of movement performed during test esecution
15783144|NCT04588155|Other|Clinical assessment|"Roland Morris Disability Questionnaire (RMDQ) to assess the level of functional impairment and disability in the activity of daily living
~Numerical Pain Rating System (NPRS) administration to quantify level of pain experienced just before the TUG test execution"
15783145|NCT04588142|Dietary Supplement|Probiotic|Non-elite athletes receive probiotic for 6 weeks
15783146|NCT04588142|Dietary Supplement|Placebo|Non-elite athletes receive placebo for 6 weeks
15783147|NCT04588129|Drug|LB-102|(N-Methyl amisulpride)
15783148|NCT04588116|Behavioral|Strategies Empowering activities in Everyday life (SEE 1.0)|"The patients are provided a person-centered activity-based intervention on the web aiming at facilitating the level of engagement in a variety of activities, at different places in society, together with other people to support an active life. In the long-term, the change to an active life will be reflected in a healthy and balanced pattern of activities.
~The program provide the patients with tools to see their activities in everyday life in a new light and, also, tools to identify activity-based strategies that can empower them to take an active role to prevent and overcome challenging situations in everyday life."
15783149|NCT04588103|Other|Heat therapy|Lower limb warm water immersion (42 degrees C)
15783150|NCT04588103|Other|Exercise training|Moderate-intensity cycling exercise (~40-59% VO2 reserve)
15783151|NCT04588090|Procedure|The concurrent 3 weeks TP regimen|paclitaxel + cisplatin regimen (TP-TAX: 150mg/m^2, DDP: 70mg/m^2 (35mg/m^2, d1, d2), 1 time/3 weeks) chemotherapy for 2 cycles.
15783152|NCT04588090|Procedure|The concurrent weekly TP regimen|paclitaxel + cisplatin regimen (TP regimen: TAX 50mg/m^2, DDP: 25mg/m^2) 6 cycles of chemotherapy
15783153|NCT04588090|Radiation|External radiation plus intraluminal after-loading irradiation|External radiotherapy of linear accelerator, CT simulation positioning, and intensity modulated radiotherapy will be applied for external radiotherapy. The prescribed dose is 95% PTV 45-50.8Gy/25-28 times (1.8Gy/time), the maximum and minimum in the target area do not exceed ±10% of the prescribed dose, and the increase in enlarged lymph nodes will reach 50-66GY. At the same time, the total dose of 192Ir high-dose rate intraluminal after-loading irradiation is 30-36Gy (EQD2: 40-48GY), and external pelvic irradiation is not available on the day of intraluminal after-loading irradiation.
15783154|NCT04588077|Biological|Heplisav-B Injectable Product, 2-dose regimen|Investigators will randomly assign patients into a 2-dose regimen.
15783155|NCT04588077|Biological|Heplisav-B Injectable Product, 3-dose regimen|Investigators will randomly assign patients into a 3-dose regimen.
15783156|NCT04588064|Diagnostic Test|68Ga-FAPI PET/CT scan|Each subject receives a single intravenous injection of 68Ga-FAPI, and undergo PET/CT imaging within the specified time.
15783157|NCT04588051|Drug|Cabozantinib|60mg daily
15783158|NCT04588038|Biological|Efineptakin alfa|Given via intramuscular injection
15783159|NCT04588025|Device|Point-of-care Portable Perfusion Phantom, P4|P4 is a perfusion phantom developed by Dr. Harrison Kim that can significantly reduce variation in quantitating perfusion of human abdominal tissues across MRI scanners.
15783160|NCT04588012|Behavioral|The online self-help Program OurRelationship developed by prof. Brian Doss and prof. Andrew Christensen.|The OurRelationship program is developed by prof. Brian Doss and prof. Andrew Christensen.
15783161|NCT04588012|Behavioral|"The off line self-help course Pas på Parforholdet."|"The book Pas på parforholdet is written by Mattias Stølen Due."
15783371|NCT04586517|Other|Heavy-load resistance training|Supervised heavy-load resistance training during chemotherapy treatment
15783162|NCT04587999|Other|bladder stimulation|"The bladder stimulation technique requires the presence of 2 people:
~The child must be held by an adult (caregiver or parent) under the armpits, legs dangling.
~the first person (the investigator), performs the stimulation technique consisting of: rapid tapping (frequency of about 100 / min), over the pubic area, at the level of the bladder, alternated with external rotational movements of the pits lumbar, in the kidneys. Alternate these 2 maneuvers every 30 seconds.
~The second person starts the stopwatch at the start of the stimulation, and is about to collect the urine, 2nd jet in a sterile pot
~The maneuver ends as soon as urine is obtained, and will be stopped after 5 minutes in case of failure."
15783163|NCT04587999|Other|Quick wee|"The Quick wee technique requires the presence of only one person:
~Stimulation of the suprapubic area by circular movements, with a cold and wet compress held by sterile forceps.
~Collection of urine in a sterile container."
15783164|NCT04587986|Device|BTL-899|Treatment with intensities of a magnetic field and radiofrequency energy just below the patient's tolerance threshold.
15783165|NCT04587973|Procedure|Group Dexmedetomidine|Ropivacaine plus dexmedetomidine group
15783166|NCT04587973|Procedure|Group Ropivacaine|Plain ropivacaine group
15783167|NCT04587973|Procedure|Group Control|Control group
15783168|NCT04587960|Procedure|Delayed primary closure of skin incision in Caesarean section in experimental group|Delayed closure of skin wound of emergency Caesarean section following wound dressing for 2-3 days in experimental group
15783169|NCT04587960|Procedure|Primary closure of skin incision in Caesarean section in active comparator group|Primary closure of skin wound (incisional) at the time of emergency Caesarean section in active comparator group
15783170|NCT04587947|Drug|sacubitril/ valsartan|Heart rate variability measurement is carried out by means of a 12-channel ECG for 30 minutes in supine position followed by 10 minutes in standing position. All parameters, including blood values and echocardiographic parameters are assessed before beginning of sacubitril/ valsartan therapy and 3 months after starting treatment
15783171|NCT04587934|Device|iRes Warmer with ResusView|Rapid heart rate display utilizing optimized ECG algorithm in iRes Warmer in babies delivered between 23+0 and 32+6 weeks estimated gestational age
15783172|NCT04587934|Other|iRes Warmer without ResusView|Electrocardiogram monitoring using external ECG monitor in babies delivered between 23+0 and 32+6 weeks estimated gestational age
15783173|NCT04587921|Device|Digital oximeter monitoring|Digital oximeter and cardiac frequency monitoring.
15783174|NCT04587908|Drug|TAS-205|・Treatment period：oral administration for 52 weeks, BID after meal
15783175|NCT04587908|Drug|Placebo|"Observation period：oral administration for 2 weeks, BID after meal
~Treatment period：oral administration for 52 weeks, BID after meal"
15783176|NCT04587895|Behavioral|VITAAL Exergame|12 weeks training with the VITAAL Exergame. The VITAAL exergame is an individualized multicomponent exergame training based mostly on the prevention and slowing of physical and cognitive decline and its consequences. It mainly consists of three (four with UI) components; strength training, balance training, cognitive training and pelvic floor muscle training (PFMT) when suffering from UI.
15783177|NCT04587895|Behavioral|Conventional Training UI|12 weeks non-individualized conventional training with a training booklet and additional walking exercise. The PFM training booklet is based on exercises that showed a reduction of incontinence in older adults while performing group pelvic floor muscle training (PFMT) and mobility exercises.
15783178|NCT04587895|Behavioral|Conventional Training MI|"12 weeks non-individualized conventional training with a training booklet and additional walking exercise. The exercises are based on recommendations from the Beratungsstelle für Unfallverhütung (bfu)."
15783179|NCT04587882|Behavioral|Telehealth|Participants will receive weekly activity summaries and tailored notifications about their activity and goal setting behaviors.
15783180|NCT04587882|Behavioral|Control|Participants will get usual care and wear a smartwatch.
15783181|NCT04587869|Behavioral|CBT Coping Intervention|A cognitive behavior therapy group intervention that addresses coping with discrimination and medical mistrust among Black sexual minority men (SMM).
15783182|NCT04587856|Other|bone marrow withdrawal|bone marrow samples evaluation
15783183|NCT04587843|Drug|Contrave 8Mg-90Mg Extended-Release Tablet|"Each Contrave Extended Release Tablet contains 8Mg of naltrexone HCl and 90Mg of bupropion HCl and will be administered orally. Total daily dose is 32Mg / 360Mg.
~Participants randomized to the treatment arm will be administered 4 Contrave tablets a day for 1 year (2 tablets taken twice a day)."
15783184|NCT04587843|Drug|Placebo|Placebo tablets will be administered orally. Participants randomized to the control arm will be administered 4 placebo tablets a day for 1 year (2 tablets, taken twice a day).
15783185|NCT04587830|Drug|ADI-PEG20|Investigational Medicine
15783186|NCT04587830|Drug|Temozolomide|Radiotherapy and TMZ are standard front-line therapy for newly diagnosed GBM.
15783187|NCT04587817|Combination Product|camrelizumab+hyperfractionated radiotherapy|Immunotherapy combined with hyperfractionated radiotherapy
15783188|NCT04587804|Device|rPMS+RF|The treatment administration phase will consist of three (3) treatments, delivered once a week. The applicator of the device will be applied over umbilicus and visible muscle contractions along with heating of the subcutaneous fat will be induced by the device.
15783189|NCT04587791|Drug|400mg Cannabidiol|Participants will receive 400mg
15783190|NCT04587791|Drug|800mg Cannabidiol|Participants will receive 800mg
15783191|NCT04587791|Drug|1200mg Cannabidiol|Participants will receive 1200mg
15783192|NCT04587791|Drug|Saline|Participants will receive saline
15783193|NCT04587778|Drug|Ketamine Hydrochloride|intravenous infusion
15783194|NCT04587778|Drug|Esketamine|intravenous infusion
15783195|NCT04587778|Drug|Placebo|intravenous infusion
15783196|NCT04587765|Behavioral|Extra-curricular sports|The group follows the schedule of school teaching programme. Extra-curricular sports classes will be organized and provided in this group of schools in the afternoon after school until 6 p.m. (Monday to Friday).
15783197|NCT04587752|Behavioral|CBT for Weight Bullying|Cognitive-behavioral therapy for weight-related bullying delivered by audio/video telehealth.
15783198|NCT04587739|Combination Product|Surgery with Neoadjuvant stereotactic body radiation therapy|Stereotactic hypofractionated robotic radiation therapy (24-45 Gy / 3 fractions) followed after 4-6 weeks by conventional hepatectomy (either anatomical liver resection, or non-anatomical liver resection with intention to achieve a minimal 2 cm margin).
15783199|NCT04587726|Behavioral|Girl's room video|"Girls Room, a body image mini-series, developed in collaboration with Lena Waithe, Dove and CAR.
~Video content was informed by empirical evidence related to body image prevention and intervention. The series consists of five, 3-minute videos.
~The videos follow the lives of a 5 best friends, and each video targets a key risk factor for body image:
~Appearance comparison
~Body appreciation
~Body talk
~Body functionality
~Appearance teasing & bullying
~Appearance focus
~The five videos aired on Instagram TV (IGTV) in March 2020."
15783200|NCT04587726|Other|Control video - Chicken Girls|Chicken Girl's Episode - appearance neutral episode matched for target audience and video length
15783201|NCT04587713|Drug|TD-1473 [Tablet A]|TD-1473 [Tablet A] (1 Tablet = Dose A) proposed commercial tablet formulation
15783202|NCT04587713|Drug|TD-1473 [Tablet B]|TD-1473 [Tablet B] (2 Tablets = Dose A) current clinical tablet formulation
15783203|NCT04587687|Drug|Bendamustine Hydrochloride|Given IV
15783204|NCT04587687|Drug|Brentuximab Vedotin|Given IV
15783205|NCT04587674|Device|Spinal Cord Stimulation|Lead(s) and Implant Pulse Generator
15783206|NCT04587661|Behavioral|off-the-shelf digital CBT|Cognitive behavioral therapy for depression and anxiety
15783207|NCT04587661|Behavioral|adapted digital CBT|Cognitive behavioral therapy for depression and anxiety for individuals from a minority group with SCD
15783208|NCT04587648|Other|NA, observational study|NA, observational study
15783209|NCT04587635|Dietary Supplement|PHGG|PHGG
15783210|NCT04587635|Dietary Supplement|Placebo|Maltodextrin
15783211|NCT04587622|Drug|Icenticaftor|Single oral dose of 300 mg of icenticaftor (QBW251)
15783212|NCT04587609|Behavioral|Free Phone Mounts|Participants will receive free phone mounts
15783213|NCT04587609|Behavioral|Commitment Contract|Participants will develop and sign a personalized commitment contract where they will create their own weekly goals for phone use reduction, and plan potential future obstacles that may hinder them from reaching their goal and how and plan to overcome that obstacle.
15783214|NCT04587609|Behavioral|Personalized Habit Tips|Participants will receive weekly habit formation tips by text message. These messages will be tailored to encourage use of phone mounts, setting up do not disturb while driving, and include their personal obstacles and plans they developed to overcome.
15783215|NCT04587609|Behavioral|Social Gamification Feedback|"Each week of the intervention period, the participant will be notified whether they met their prior week's goal, stayed about the same, or backslid. Participants will all start with 100 points, and can gain/maintain/lose points each week in the intervention period. Levels are as follows:
~Copper: 0-40 points Bronze: 50-80 points Silver: 90-120 points Gold: 130-160 points Platinum: 170-200 points
~Social competition: participants will be placed in groups of 10 based on similarity of baseline phone use. Weekly leaderboard reports will be sent via email, with SMS reminder. In the leaderboard they'll see themselves as You."
15783216|NCT04587609|Behavioral|"Contest Financial Incentives"|"Participants who finish in the platinum level will receive equal share of a prize, or a small amount will be awarded each week over the course of the intervention period to the weekly Safest Driver in each of the social competition cohorts."
15783217|NCT04587596|Other|Pain education|70 minute lecture about chronic pain and one focus group afterwards
15783218|NCT04587583|Behavioral|WeCareAdvisor|Tailored, internet-based software intended to assess, manage and track behavioral symptoms and their contributing factors and to instruct dementia caregivers in problem solving approaches (tailored strategies for in-home, medication-free behavior management) to address difficult or disruptive behaviors exhibited by the person with dementia. During the testing period participants will refer to the WeCareAdvisor when behavioral challenges occur.
15783219|NCT04587570|Procedure|Infiltration with PRP|Infiltration with 1.5 ml PRP
15783220|NCT04587570|Procedure|Infiltration with Fat|Infiltration with 1.5 ml Fat
15783221|NCT04587570|Procedure|Infiltration with PRP and Fat|Infiltration with 0.75 ml PRP and 0.75 ml Fat
15783222|NCT04587570|Procedure|Infiltration with NaCl|Infiltration with 1.5 ml NaCl
15783223|NCT04587557|Behavioral|Storytelling with social contextual information|Four out of 100 stories from a storytelling app (SAHK, 2013) that incorporated social contextual information, and inter-personal skills were selected. The intervention was in small group format, consisted of eight sessions across four weeks, two sessions per week, 30 minutes per session.
15783224|NCT04587557|Behavioral|Storytelling without social contextual information|Four out of 100 stories from a storytelling app (SAHK, 2013) without social contextual information, and inter-personal skills were selected. The intervention was in small group format, consisted of eight sessions across four weeks, two sessions per week, 30 minutes per session.
15783225|NCT04587557|Other|Children with ASD|Four out of 100 stories from a storytelling app (SAHK, 2013) were selected for children with ASD.
15783226|NCT04587557|Other|Children with TD|Four out of 100 stories from a storytelling app (SAHK, 2013) were selected for children with TD.
15783227|NCT04587544|Behavioral|Cold Water Immersion|The participants maintained their daily activities during the intervention. When daily activity ended, the intervention was begun. CWI therapy by immersed the whole part of inflamed target joints in the water at 20-30C for 20 minutes/day. The intervention was continued for four weeks. The researchers work together with the nurses of community health services to give the intervention.
15783228|NCT04587531|Device|Cranial Electrotherapy Stimulation|Alpha-Stim® AID microcurrent and cranial electrotherapy stimulator will be used. Daily one hour cranial electrotherapy stimulation (CES) treatment using ear clip electrodes with current set at fixed level of 100 uA (a subsensory current level), 0.5 Hertz will be used for active CES treatment group for 6 weeks. For the sham group the Alpha-Stim® AID ear clips will not emit electricity.
15783259|NCT04587258|Behavioral|Informational videos and social media campaigns encouraging cancer screening.|Informational videos will be made using community members and will be played in the Blackstone Valley Health Center, as well as posted on social media platforms, such as Facebook and Instagram. These videos will encourage at risk populations in the selected areas to visit their physicians to discuss the possibility of undergoing screening procedures for either breast or colorectal cancer. Data will then be collected about the rates of screening and will be compared to the screening rates from the time period of March 9th 2020 to May 31st 2020, with the goal of increasing screening rates by 25%.
15783369|NCT04586530|Behavioral|Memory and Attention Adaptation Training (MAAT)|A cognitive-behavioral therapy (CBT) for treatment of chemotherapy-related cognitive dysfunction (CRCD) among cancer survivors.
15783230|NCT04587505|Procedure|Epidural anesthesia with light general anesthesia|Epidural anaesthesia: mixture of ropivacaine 6.5 mg/ ml and fentanyl 8.3 μg/ml. Light general anesthesia: isoflurane in mixture of 50/50 of nitrous oxide and oxygen to achieve Minimum alveolar concentration between 0.6 and 0.8.
15783231|NCT04587505|Drug|Postoperative epidural analgesia|Before the end of operation was given 4 ml of the mixture of ropivacaine 4.4 mg/ml and morphine 0.8mg/ ml. Epidural analgesia was continued for next 24 hours with a mixture of ropivacaine 2.2 mg/ml and morphine 0.4 mg/ml.
15783232|NCT04587505|Procedure|General anesthesia|Maintaining general anesthesia: nitrous oxide and oxygen in mixture 50/50 and isoflurane to achieve minimum alveolar concentration between 0.8 and 1. Fentanyl loading dose: 6-8 μg/kg. Additional fentanyl doses were given incrementally.
15783233|NCT04587505|Drug|Continuous intravenous analgesia|Tramadol 100 mg in the first hour followed by tramadol 300 mg continuously for the next 24 hours.
15783234|NCT04587492|Drug|Nusinersen|Treatment with nusinersen
15783235|NCT04587479|Drug|JAB-8263|Variable dose, orally Q2D with 28 days each cycle
15783236|NCT04587453|Drug|Tralokinumab|Tralokinumab is a human recombinant monoclonal antibody of the immunoglobulin G4 subclass that specifically binds to human interleukin-13 (IL-13) and blocks the interaction with IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.
15783237|NCT04587453|Drug|Placebo|Placebo contains the same excipients in the same concentration only lacking tralokinumab.
15783238|NCT04587453|Other|Topical corticosteroids (TCS)|TCS administered as needed.
15783239|NCT04587440|Other|Pelvic inclination measurement|Ultra-sound based measurements of the pelvic inclination lying, standing and seating position. EOX X-ray in seating position.
15783240|NCT04587427|Drug|Radium 223 dichloride (Xofigo, BAY88-8223)|Prescribed by physicians.
15783241|NCT04587414|Behavioral|eHealth +counselling contacts|The 6 month eHealth intervention comprises continuous self-monitoring of PA and SB using hip-worn accelerometer and ExSed application, which gives cloud-computed personal feedback about accelerometer-measured PA and SB on smartphone and provides a platform for a health care professional to set and monitor patient's personal activity goals as well as give personalized feedback to the patient. In addition, instructions and video-demonstrations on how to reach the goals are provided via Internet. The eHealth intervention is complemented by face-to-face and telephone counselling on physical activity which comprises 4 to 6 contacts between a health care professional and the patient as well as at least 3 telephone contacts during 6 months.
15783242|NCT04587414|Behavioral|eHealth|The 6 month eHealth intervention comprises continuous self-monitoring of PA and SB using hip-worn accelerometer and ExSed application, which gives cloud-computed personal feedback about accelerometer-measured PA and SB on smartphone and provides a platform for a health care professional to set and monitor patient's personal activity goals as well as give personalized feedback to the patient. In addition, instructions and video-demonstrations on how to reach the goals are provided via Internet. No telephone calls nor face-to-face counselling contacts on physical activity are taken.
15783243|NCT04587414|Behavioral|Usual care|Usual care and councelling given to type 2 diabetics within the primary health care setting.
15783244|NCT04587401|Procedure|normotensive patients|patients who do not have high blood pressure diagnosis and actual blood pressure is within the normal range
15783245|NCT04587401|Procedure|patients with hypertension diagnosis|Patients who have high blood pressure diagnosis
15783246|NCT04587401|Procedure|patients who do not know they are hypertensive but actual blood pressure is high|patients with preoperative high blood pressure, who do not know they are hypertensive
15783247|NCT04587362|Diagnostic Test|Musculoskeletal Ultrasound|High quality ultrasound scanners and high-resolution transducers, will be used to scan 16 joints sites for each subject. Ultrasound had excellent spatial resolution, making it an highly efficient, non-invasive tool for the assessment on enthesitis, which is an early feature of psoriatic arthritis. It is an affordable and accessible tool that is widely used in rheumatology practice.
15783248|NCT04587349|Other|Neurorehabilitation|Neurorehabilitation - 2 years-long intervention, targeted postural instability and mobility using at-limit intensity sensori and visuomotor agility training. (2/ week)
15783249|NCT04587349|Other|Neurorehabilitation|Neurorehabilitation - 2 years-long intervention, targeted postural instability and mobility using at-limit intensity sensori and visuomotor agility training. (3/ week)
15783250|NCT04587349|Other|Physiotherapy|Physiotherapy 2-years-long (3/week)
15783251|NCT04587336|Behavioral|Cognitive Interview|Cognitive Interviews: Examine the understanding and interpretation of diabetes distress and the Diabetes Distress Scale in Veterans with T2D.
15783252|NCT04587336|Behavioral|Baseline Survey|Conduct Baseline Survey: Examine the association of psychosocial factors (depression, PTSD), environmental factors (finances, support), self-management behaviors, and HbA1c with DD.
15783253|NCT04587336|Behavioral|Qualitative Interviews|Qualitative Interviews: Describe self-management challenges and preferred learning strategies to inform intervention components and delivery approach for Veterans with T2D.
15783254|NCT04587336|Behavioral|TARDIS Intervention|TARDIS Intervention: Design & pilot test an innovative, tailored self-management information and supportive services intervention for Veterans with T2D, to promote engagement in self-management behaviors
15783255|NCT04587310|Diagnostic Test|Laparoscopic Sleeve Gastrectomy|bariatric surgery
15783256|NCT04587271|Dietary Supplement|Moringa oleifera (high dose)|Mothers will receive 20 grams of moringa leaf powder in porridge consumed daily for three months.
15783257|NCT04587271|Dietary Supplement|Moringa oleifera (low dose)|Children will receive 5-10 grams of moringa leaf powder in porridge consumed daily for three months.
15783261|NCT04587232|Diagnostic Test|Turkish version of Mini Osteoarthritis Knee and Hip Quality of Life Questionnaire|Turkish version of Mini Osteoarthritis Knee and Hip Quality of Life Questionnaire (Mini-OAKHQoL) was derived from the Turkish version of OAKHQoL questionnaire, which was developed to assess the quality of life (QoL) in subjects with lower limb osteoarthritis. It includes five subscales: physical activities, mental health, pain, social support, social functioning; with three additional independent items addressing sexual life, professional life, and fear of being dependent. The numerical rating scales in the items range from 0 (worst) to 10 (best). Scores were obtained by computing the means of the item scores in each subscale. The last three items' score (independent items) becomes the corresponding score.
15783262|NCT04587232|Diagnostic Test|Nottingham Health Profile|Standardized questionnaire to investigate the health-related quality of life. NHP is a general is used to measure health problems perceived by the patient. It comprises 6 sections. The sum of the items within each section ranges from 0 to 100, and the total score ranges from 0 to 600. The higher score shows a worse quality of life.
15783263|NCT04587232|Diagnostic Test|Short form 36|Standardized questionnaire to investigate the general health-related quality of life. The SF-36 questionnaire is a generic quality of life questionnaire and consists of 8 subscales, with 36 items. The scores ranges from 0 to 100 and the high score indicates good health.
15783264|NCT04587232|Diagnostic Test|Western Ontario and McMaster|Standardized questionnaire to investigate the health status of patients with osteoarthritis. The WOMAC OA index assesses the symptomatic severity and disability with pain, stiffness, and physical function domains. Each subscale was summated to a maximum score of 20, 8, and 68, respectively, with the higher scores corresponding worst health status.
15783265|NCT04587219|Biological|Gam-COVID-Vac|combined vector vaccine, 0,5ml/dose+0,5 ml/dose prime-boost immunization in days 1 (component I rAd26-S) and 21(component II rAd5-S)
15783266|NCT04587206|Drug|CKD-348|QD, PO
15783267|NCT04587206|Drug|CKD-828, D097, D337|QD, PO
15783268|NCT04587193|Device|Robotic-assist gait training device|PD participants will walk while wearing a robotic-assist gait training device
15783269|NCT04587180|Procedure|Arthroscopic suture-bridge rotator cuff repair|Arthroscopic suture-bridge repair is a widely used and universal surgical method for symptomatic rotator cuff tear patients. It is arthroscopic surgery to reattach ruptured rotator cuff tendons to the original insertion (greater tuberosity) using medial and lateral row anchors.
15783270|NCT04587167|Other|Project ECHO|"Using proven adult learning techniques and interactive video technology, the ECHO Model promotes knowledge exchange between experts or specialists at centers of excellence (the hub) and primary care providers (the spokes), typically located in rural settings. Through regular real-time collaborative sessions, the spokes connect with the hub and with other spokes to discuss 1) best practices in care and 2) complex cases managed within their practice."
15783271|NCT04587167|Other|Announcement Approach Training|Train physicians and their clinic staff to make strong HPV vaccine recommendations by using presumptive announcements. If parents show vaccine hesitancy, the Training train physicians a 3-step approach (Connect, Clarify, Counsel) to share effective, evidence-based messages about HPV vaccine.
15783272|NCT04587167|Other|Recall notices|Notify parents that their child is behind for HPV vaccination. Recall notices will include research-tested messages to specifically address parent concerns. Recall notices will be sent to parents via patient portal or email communication.
15783273|NCT04587154|Other|low-fat vegan diet with 1/2 cup soybeans daily|Weekly instructions will be given to the participants in the intervention group about following vegan diet with 1/2 cup of soybeans daily.
15783274|NCT04587141|Drug|Sucrosomial iron|This is an oral iron formulation commercially available as an integrator
15783275|NCT04587141|Drug|Ferric Gluconate|This is a commercially available iron formulation for parenteral administration
15783276|NCT04587141|Drug|Ferric carboxymaltose|This is a commercially available iron formulation for parenteral administration
15783277|NCT04587128|Drug|Panitumumab|Epidermal growth factor receptor inhibitor, anti-neoplastic
15783278|NCT04587128|Drug|Cetuximab|Epidermal growth factor receptor inhibitor, anti-neoplastic
15783279|NCT04587128|Drug|Irinotecan|anti-neoplastic, chemotherapy drug
15783280|NCT04587115|Drug|Risperidone|Risperidone 1mg to be used in combination with other drugs
15783281|NCT04587115|Drug|Ziprasidone|Ziprasidone 80mg to be used in combination with other study drugs
15783282|NCT04587115|Drug|Oxycodone|Oxycodone alone in a capsule will be considered the control. Oxycodone 15 mg will also be used in combination with other study drugs
15783283|NCT04587102|Other|whole body viberation|vibration training in the form of whole body vibration for 20-30 minutes per session, 3 sessions per week for 8 weeks. The vibration training was performed on a whole body vibration platform
15783284|NCT04587102|Other|Traditional program(balance exercises and resisted exercises)|balance exercises and resisted exercises
15783285|NCT04587089|Procedure|Conventional Endodontic Treatment|Convencional endodontic treatment for deciduous teeth will be conducted with surgical chemical preparation. Series of Kerr files of appropriate for each case will be selected, using an initial file and an additional two files of larger size, irrigation and aspiration with 1% sodium hypochlorite (Milton's solution) and endo PTC (Fórmula & Ação) with each change of file.
15783286|NCT04587089|Procedure|Irrigation|Irrigation and aspiration in the root canals with 1% sodium hypochlorite (Milton's solution).
15783287|NCT04587089|Radiation|Antimicrobial Photodynamic Therapy (aPDT)|The Therapy XT-EC (DMC ABC Medical and Dental Equipment, São Carlos, SP, Brazil) will be used for PDT, with laser emission in the red band (660 nm) and the narrow tip for the specific use of PDT in areas of difficult access. One session of PDT with the Chimiolux® methylene blue photosensitizer (Hypofarma, Belo Horizonte, MG, Brazil) at a concentration of 0.005 % will be performed in the interior of the root canal. The photosensitizer will be applied with a sterile paper cone for 3 minutes and the excess will be removed with an endodontic aspirator. The canal will be irradiated for 40 seconds, with the device previously calibrated to emit a wavelength at 660 nm, with radiant energy of 4 J and mean maximum power of 100 mW. The direct contact method will be employed.
15783370|NCT04586530|Behavioral|Supportive Therapy (ST)|Standard attention control condition therapy for treatment of chemotherapy-related cognitive dysfunction (CRCD) among cancer survivors.
15783288|NCT04587089|Procedure|Filling with Guedes-Pinto Paste|The root canals will be filled with Guedes-Pinto Paste, which is a composite of 3 medications: Rifocort® (dermatologic ointment), camphorated paramonochlorophenol (PMCC) and iodoform. It will be prepared at the moment of use with the same proportion in volume of 3 visually identical parts, one for each of its components.
15783289|NCT04587063|Behavioral|Fear Appeals|Email
15783290|NCT04587063|Behavioral|Message about Future Healthcare Costs|Email
15783291|NCT04587063|Behavioral|Endorsement from a Doctor|Email
15783292|NCT04587063|Behavioral|Comparison Table|Email
15783293|NCT04587063|Behavioral|Highlighting Cost Savings and Convenience|Email
15783294|NCT04587050|Diagnostic Test|Human papillomavirus testing|HPV test from cervical sample using Cepheid GeneXpert HPV
15783295|NCT04587050|Diagnostic Test|Cervical cytology|Cervical cytology
15783296|NCT04587050|Diagnostic Test|HPV serology|HPV type specific serology (16/18) using ELISA from serum samples
15783297|NCT04587037|Procedure|fascia lata allograft|underwent superior capsule reconstruction using fascia lata allograft
15783298|NCT04587037|Procedure|human dermal allograft|underwent superior capsule reconstruction using human dermal allograft
15783301|NCT04587011|Drug|Tegoprazan dose A or placebo|Tegoprazan A mg or placebo taken orally twice daily for 3 days.
15783302|NCT04587011|Drug|Tegoprazan dose B or placebo|Tegoprazan B mg or placebo taken orally twice daily for 3 days.
15783303|NCT04587011|Drug|Tegoprazan dose C or placebo|Tegoprazan C mg or placebo taken orally twice daily for 3 days.
15783304|NCT04587011|Drug|Tegoprazan dose D or placebo|Tegoprazan D mg or placebo taken orally twice daily for 3 days.
15783305|NCT04586998|Device|"Exhaled drug monitor Edmon"|Taking samples of exhaled breath every minute during elective surgery in comparison to blood samples taken at predefined time points.
15783306|NCT04586985|Drug|FTX-6058/placebo oral capsule(s)|Subjects will receive FTX-6058 or matching placebo.
15783307|NCT04586985|Drug|FTX-6058 oral capsule(s) - Two dosing periods|Subjects will receive FTX-6058 in two dosing periods
15783308|NCT04586985|Drug|FTX-6058 oral capsule(s) / Midazolam Syrup|Subjects will receive FTX-6058 and midazolam syrup
15783309|NCT04586959|Device|Surgery with UM|The experimental group will have MIS with the placement of a uterine manipulator
15783310|NCT04586959|Device|Surgery without UM|The control group will have MIS without the placement of a uterine manipulator
15783311|NCT04586933|Dietary Supplement|Omega-3|It will be investigated whether diet optimization and supplementation of omega-3s can reduce disease activity in patients with inflammatory arthritis. A new omega-3 high concentrate from GC Rieber Oils will be used.
15783312|NCT04586933|Dietary Supplement|Placebo (soya)|Placebo (soya)
15783313|NCT04586933|Behavioral|Dietary guidance|Dietary guidance
15783314|NCT04586920|Drug|LY3509754|Administered orally
15783315|NCT04586920|Drug|Placebo|Administered orally
15783316|NCT04586920|Drug|Itraconazole|Administered orally
15783317|NCT04586920|Drug|Midazolam|Administered orally
15783318|NCT04586907|Drug|LY3537021|Administered SC.
15783319|NCT04586907|Drug|Placebo|Administered SC.
15783320|NCT04586894|Diagnostic Test|Cardiac MRI|Gadolinium-enhanced magnetic resonance imaging of the heart before the first cycle of chemotherapy
15783321|NCT04586894|Device|Smart cloth|A smart cloth recording cardiac and hemodynamic parameters will be worn by patients during 42 days. Replaced by a holter monitor if the smart cloth is refused or not tolerated by the patient.
15783322|NCT04586894|Other|Biobanking|Blood samples (plasma, serum, DNA, stem cells, immune cells) taken as part of the study will be stored in a biological sample collection. These samples may be used for further analysis not described in the initial protocol but which may be useful for investigation or in light of advances in scientific knowledge.
15783323|NCT04586868|Behavioral|An intervention development study|Assessing the acceptability for a virtual reality intervention among adolescents with psychosis
15783324|NCT04586868|Behavioral|A randomized feasibility study|Feasibility of virtual reality environment for adolescents with psychosis
15783325|NCT04586868|Behavioral|A single-case study|The clinical efficacy of a novel VR-assisted CBT interventions for adolescents with psychosis
15783326|NCT04586855|Diagnostic Test|Diagnostic Ultrasound|To investigate if Ultrasound imaging can visualize the larynx during NIV and Cough Assist, and be as accurate as laryngoscopy
15783327|NCT04586855|Diagnostic Test|Transnasal Fiberoptic Laryngoscopy|To investigate if Ultrasound imaging can visualize the larynx during NIV and Cough Assist, and be as accurate as laryngoscopy
15783328|NCT04586842|Behavioral|Community-based Occupational Therapy|Domiciliary and Community-based Occupational Therapy on mental health and ABI intervention, developed on the basis of the Model Of Human Occupation.
15783329|NCT04586842|Behavioral|Standard community-based intervention|Interventions received at the community, public or private level (e.g. community nursing, social education and/or psychology).
15783330|NCT04586829|Other|Diet|<50 grams of total carbohydrates per day. Monosaturated fats consumption will be encouraged over saturated fats.
15783331|NCT04586816|Combination Product|1% red maple leaf extract in cream base|1% red maple leaf extract is combined in a cream base
15783332|NCT04586816|Combination Product|5% red maple leaf extract|5% red maple leaf extract is combined in a cream base
15783333|NCT04586816|Combination Product|vehicle|vehicle cream base only
15783334|NCT04586803|Drug|SHR4640|Subjects were randomly divided into the group A, B, C, D, E and F. On D1, D8 and D15, six groups of subjects were respectively given A version or C version or D version of SHR4640 tablet.
15783335|NCT04586790|Drug|Midodrine Oral Tablet|midodrine group will receive midodrine 10 mg PO q 8 hr with gradual weaning of IV nor-adrenaline after receiving 4 doses of oral midodrine .
15783336|NCT04586790|Drug|Minirin oral tablet|Minirin group will receive minirin 60 µg PO q 8 hr with gradual weaning of IV nor-adrenaline after receiving 4 doses of oral minirin .
15783337|NCT04586790|Drug|Nor-Adrenaline|control group will receive IV nor-adrenaline and is gradually weaning from it according to routine hospital care without adding oral midodrine or oral minirin .
15783338|NCT04586777|Device|transvertebral direct current stimulation (tvDCS)|tvDCS is a painless, non-invasive form of spinal stimulation which delivers safe, low levels of electrical current to the spinal cord through the back. It is believed to be able to influence the excitability of the brain and spinal cord.
15783339|NCT04586764|Device|Non-Invasive Cardiac System|Non-Invasive Cardiac System (NICaS, NI Medical, Israel) is a non-invasive hemodynamic monitoring system that records various cardiovascular parameters including stroke volume, cardiac output, cardiac index (CI), total peripheral vascular resistance, body water content, and cardiac power index, a marker of myocardial contractility by employing the principles of the whole body impedance cardiography.
15783342|NCT04586738|Procedure|non-perforating deep sclerectomy surgery|Non-penetrating deep sclerectomy is a non-perforating filtration procedure used for the surgical treatment of medically uncontrolled open angle glaucoma.This surgery is performed to facilitate the outflow of aqueous humour from the anterior chamber to the subconjunctival space through a natural membrane (trabeculo-Descemet's window). This enables a more physiological reduction of intraocular pressure to be achieved.
15783343|NCT04586725|Other|Encouragement a one minute intervals|Patients will perform the six exercise tests with encouragement at one minute intervals
15783344|NCT04586725|Other|Encouragement a two minute intervals|Patients will perform the six exercise tests with encouragement at two minute intervals
15783345|NCT04586712|Drug|High dose CBD|Participants will be provided a viscous liquid in a bottle with a syringe dropper containing CBD-extract oil at concentrations of 1000mg/30mL (high).
15783346|NCT04586712|Drug|Low Dose CBD|Participants will be provided a viscous liquid in a bottle with a syringe dropper containing CBD oil at concentrations of 500mg/30mL (low)
15783347|NCT04586712|Drug|Vehicle Control Group|Participants will be provided a viscous liquid in a bottle with a syringe dropper containing placebo containing no CBD oil (0mg/30 mL).
15783348|NCT04586699|Device|Medi1TMS|rTMS theta-burst protocol paired with a consistent attention-to-breath task
15783349|NCT04586699|Device|Medi2TMS|rTMS theta-burst protocol paired with an intermittent deep breathing task
15783350|NCT04586686|Procedure|Ovarian biopsy via laparoscopy|A laparoscopy will be performed to achieve an ovarian cortical biopsy of one of both ovaries. Approximately twenty % of the ovarian volume as initially measured on the baseline ultrasound at the first visit will be removed to be processed in the lab for cortex freezing. The laparoscopic procedure in order to take the ovarian cortex biopsy will be standardised as much as possible. The technique developed by ProFam will be followed and adapted if needed by the surgeon's discretion. A three to four port laparoscopy will be used. The ovarian cortex biopsy will be taken using a curved scissor. Bipolar or unipolar cauterisation will be avoided as much as possible. If necessary for approximation or for hemostatic reasons, the ovarian edges can be stitched or Surgicel ® Absorbable Hemostat can be used.
15783351|NCT04586686|Procedure|Transvaginal oocyte retrieval|After ovarian stimulation, a transvaginal oocyte retrieval will be performed either under local or general anaesthetics (patient's choice). The oocyte yield between the biopsied and non-biopsied ovary will be evaluated.
15783352|NCT04586673|Biological|ChAdOx1.tHIVconsv1 (C1)|ChAdOx1.tHIVconsv1 5 x 10^9 vp
15783353|NCT04586673|Biological|ChAdOx1.tHIVconsv1 (C1)|ChAdOx1.tHIVconsv1 5 x 10^10 vp
15783354|NCT04586673|Biological|MVA.tHIVconsv3 (M3)|MVA.tHIVconsv3 1 x 10^8 pfu
15783355|NCT04586673|Biological|MVA.tHIVconsv4 (M4)|MVA.tHIVconsv4 09. x 10^8 pfu
15783356|NCT04586660|Drug|XGEVA®|Participants will receive XGEVA® 120 mg subcutaneously (SC) once every 4 weeks (Q4W) with a loading dose of 120 mg SC on day 8 and day 15.
15783357|NCT04586647|Behavioral|Noom Healthy Weight; mobile behavior change program for weight loss.|"The intervention consists of a curriculum, provided through daily articles that users are encouraged to read; logging features for weight, meals, and physical activity; in-app groups; and a virtual coach, who will communicate with participants via in-app messaging. During the first week of the study, participants will be introduced to the program, the Noom app, and their coach.
~Coaches will use a secure dashboard to monitor patient progress, which is used to increase engagement and motivation. Participants are encouraged to log their weight and physical activity on a weekly basis, and meals daily."
15783358|NCT04586634|Device|Peristeen cone catheter|The active intervention is the Peristeen cone catheter device. The comparator in this investigation is current standard of care for patients with LARS which is conservative bowel management.
15783359|NCT04586621|Device|Atoldys/ Lexilens - SHAM|Atoldys/ Lexilens: glasses with specific light frequency SHAM: glasses with no frequency
15783360|NCT04586621|Device|SHAM- Atoldys/ Lexilens|SHAM: glasses with no frequency Atoldys/ Lexilens: glasses with specific light frequency
15783361|NCT04586608|Dietary Supplement|MCT/ω-3 fatty acids|The provision of ω-3 fatty acids to premature neonates in the Parenteral Nutrition.
15783362|NCT04586608|Dietary Supplement|soybean oil-based IVFE|soybean oil-based IVFE
15783363|NCT04586595|Other|REVISiT intervention|REVISiT is a pharmacist-led retrospective review of prescribing followed by a feedback meeting to discuss the review findings.
15783364|NCT04586582|Diagnostic Test|ST-segment resolution <40.15%|Forty-two STEMI patients with single-branch coronary artery stenosis or occlusion were enrolled. ST-segment elevations were measured at emergency admission and at 24 h after PCI. Late gadolinium-enhanced cardiac magnetic resonance imaging (CMR-LGE) was performed 7 days after PCI to evaluate myocardial scars.
15783365|NCT04586569|Other|Pediatric Interactive Relational Agent (PIRA)|The PIRA is an interactive, online tool used to educate children and families about their child's upcoming surgical and anesthesia experience.
15783366|NCT04586556|Diagnostic Test|Polyps detection by Artificial Intelligence|The AI system will capture the live video of the procedure and the AI feedback (polyp detection, tracking, and pathology prediction) will be shown on a second screen installed next to the regular endoscopy screen. Screen A will show the regular endoscopy image and screen B will show the regular endoscopy image together with the areas that might harbor a polyp or the information to predict pathology
15783367|NCT04586543|Drug|Selegiline|10 mg selegiline tablet per day
15783368|NCT04586543|Drug|Docetaxel|75mg/m2 docetaxel infusion every 3 weeks for maximum of 12 cycles
15783372|NCT04586517|Other|Control|Activity as usual during chemotherapy
15783373|NCT04586504|Drug|Intranasal midazolam|5 mg/mL concentration of midazolam. Maximum dose = 10 mg. Administered using a mucosal atomization device.
15783374|NCT04586491|Combination Product|Oral care protocol|Oral care protocol
15783375|NCT04586478|Biological|single dose of CNCT19|Dose: 2.00 x 10^8 CNCT19 Cell Injection via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide
15783376|NCT04586465|Drug|pembrolizumab, pemetrexed, gemcitabine, cisplatin, carboplatin|"Patients will receive 3 cycles pembrolizumab 200mg, fix dose, 60 minute IV infusion combination with chemotherapy.
~Chemotherapy regimen: ① Eligible patients with non-squamous cell lung cancer, Pemetrexed 500mg/m2, IV infusion on day 1 and cisplatin 75mg/m2 or carboplatin area under the curve (AUC=5), on day 1 of a 3-week schedule for 3 cycles. ② Eligible patients with squamous cell lung cancer. Patients will receive gemcitabine 1250mg/m2 IV on day 1 and day 8, and cisplatin 75mg/m2 or carboplatin AUC=5 on day 1 of a 3-week schedule for 3 cycles"
15783377|NCT04586452|Diagnostic Test|AAA Group (Aim 3A)|"The primary goal is to relate preoperative 64Cu-DOTA-ECL1i AAA uptake with CCR2+ cell activity in AAA tissue collected at the time of open repair. We will image AAA patients pre-operatively and collect tissue at the time of open repair in an attempt to demonstrate ex-vivo tissue corroboration of our imaging findings (n=20, 10 women and 10 men).
~Participants with AAA will undergo routine clinical evaluation including ultrasound, CT scan and scheduling of open surgical repair. We will record age and tobacco use. If a renal function blood test has not been performed within the past 90 days, we will draw ~2 teaspoons of blood for a creatinine test. A contrast dye will be used for the CT portion of the PET-CT scan. Those having open surgery, their PET/CT imaging will be within 7-14 of the surgery and if available, collection of discarded aortic tissue at the time of surgery."
15783378|NCT04586452|Diagnostic Test|Non-AAA Group|We will determine the retention of 64Cu-DOTA-ECL1i in abdominal aorta of non-AAA volunteers (n=10, 5 women and 5 men). This group of participants will have a documented absence of AAA by screening ultrasound that was previously obtained as part of standard care. Both men and women, between the ages of 40 - 80, with or without active tobacco use and medically managed hypertension (high blood pressure) and hyperlipidemia (high blood cholesterol levels).
15783379|NCT04586452|Other|Ex Vivo Human AAA Specimens (Aim 2A)|The primary objective of this sub-aim is to assess the sensitivity and specificity of 64Cu-DOTA-ECL1i binding to ex vivo to human AAA specimens from the Washington University Vascular Surgery Biobank (VS-BB). We will first perform a histopathological evaluation of human AAA specimens (n=75, including samples from this study) and categorize them based on clinical status (e.g, diameter) and degree of inflammation. We will consider healthy, nonatherosclerotic aorta (n=25) as negative controls, and non-aneurysmal aortas (n=25) from patients that have undergone surgery for aortoiliac occlusive disease as positive controls.
15783380|NCT04586452|Other|Relationship between radiotracer and CCR2 (Aim 2B)|The objective of this sub-aim is to better understand the relationship between the levels of CCR2+ inflammatory cells and the inflammatory and clinical status of AAA, to gain insight into the importance of proinflammatory monocytes/macrophages in the development of AAA disease at the time of elective AAA repair. We will correlate the level of MMP expression and activity, as well as cytokine profiles, of each specimen, with the associated histopathological features. The relationship between 64Cu-DOTA-ECL1i binding and CCR2 expression in tissues with different degrees of disease severity will be evaluated using Pearson or Spearman correlation coefficients. This will allow us to speculate as to how tracer uptake will perform in vivo and what that uptake represents in regard to disease severity.
15783381|NCT04586452|Diagnostic Test|AAA Group (Aim 3B-Reproducibility)|We will demonstrate consistent 64Cu-DOTAECL1i uptake by performing repeated imaging studies in a separate group of non-surgical AAA patients (n=20, 10 women and 10 men). Completion of this sub-aim will provide support for the use of 64Cu-DOTA-ECL1i PET for evaluating AAA disease in a reliable fashion. These participants will have another PET/CT imaging study performed 10-14 days after the first PET/CT in order to determine the ability to reproduce the uptake results of Cu-64-DOTA-ECL1i. The physician will assess the participant's willingness and eligibility to have a second PET/CT scan.
15783382|NCT04586439|Drug|JNJ-73763989|JNJ-73763989 will be administered (high or low dose) as single SC injection.
15783383|NCT04586426|Drug|Talquetamab|Talquetamab will be administered by subcutaneous (SC) injection.
15783384|NCT04586426|Drug|Teclistamab|Teclistamab will be administered by SC injection.
15783385|NCT04586426|Drug|Daratumumab|Daratumumab will be administered by SC injection.
15783386|NCT04586413|Other|No intervention - quality of life measure|Participants will be part of the creation of a Post-COVID-19 quality of life measure if involved in Phase One. In Phase Two participants will complete this post-COVID-19 quality of life measure monthly for 12 months
15783387|NCT04586387|Device|intermittent theta burst stimulation (iTBS)|repetitive non-invasive brain stimulation protocol which feels like many quick, light taps on your head
15783388|NCT04586361|Combination Product|RegenLab PRP|PRP preparations also improved functional outcome scores compared to hyaluronic acid and placebo in patients affected by knee osteoarthritis (OA). Based on previous studys, we can conclude that the PRP treatment is a safe and efficacious procedure which can provide functional benefit.
15783389|NCT04586361|Combination Product|hyaluronic acid|Few studies investigated the effects of HA+PRP combined treatment for knee osteoarthritis (OA). Numerous studies demonstrated the efficacy of HA injection therapy in knee OA for a clinical point of view, reducing the pain and improving the quality of life.
15783390|NCT04586361|Other|normal saline|In this study, we compare introperative PRP/PRP+HA/normal saline in ACL reconstruction patient.
15783391|NCT04586348|Combination Product|Low Iodine Supplement|Multivitamin and mineral supplement with reduced iodine
15783392|NCT04586348|Combination Product|Standard Iodine Supplement|Multivitamin and mineral supplement with standard amount of iodine to match current leading brands of prenatal supplements
15783393|NCT04586335|Drug|CYH33|Clinical Activity of CYH33, an Oral α-specific PI3K Inhibitor in Combination with Olaparib, an Oral PARP Inhibitor
15783394|NCT04586322|Other|No intervention, (observational study).|"From every participant the following information was recorded for further analysis:
~BEWE score- Basic erosive tooth wear examination (from 2 calibrated examiners) to diagnose the presence of erosive tooth wear.
~Their answer to a validated questionnaire assessing the dietary habits based in the frequency of acidic diet.
~2 Intra oral scans (IOS): Baseline and follow up (1 year after baseline) to perform a quantification of tissue loss (in Volume loss per mm3) using Wearcompare software."
15783617|NCT04584684|Drug|0.5% w/v Povidone-iodide|Over-the-counter broad spectrum iodine antiseptic
15783395|NCT04586309|Behavioral|Transcendental meditation|"Instruction in the TM technique is taught over five sessions.
~Introductory session-Review of previous scientific research on the TM program and a vision of possible benefits; Preparation- discussion of the mechanics and origin of the TM technique After the introductory session, a Personal Interview is conducted telephonically-with a teacher of the TM program.
~Personal Instruction-individual one-on-one instruction in the TM technique. The student learns the mechanics of the TM technique. At the conclusion of this class the student is able to meditate properly.
~First Day of Verification of Correct Practice and Further Instruction.
~Second Day of Verification of Correct Practice-understanding the mechanics of the TM technique from personal experiences.
~Third Day of Verification of Correct Practice-understanding the mechanics of the development of higher human potential and wellness."
15783396|NCT04586296|Other|Telemedicine|IVR will consist of a 3 minute call at a decreasing interval from the time of surgery. Questions will assess pain control, signs of infection, prosthesis failure.
15783397|NCT04586283|Other|Maternal prone position|Women will be asked to lie in a prone position supported by a specially designed cushion for 30 minutes.
15783398|NCT04586270|Drug|TAS0612|oral tablets
15783399|NCT04586257|Procedure|Erector spinae plane block|While patients in the prone position, 1.4-5.1 MHz low-frequency probe (C5-1s convex transducer) will be first placed in a longitudinal orientation in the midline to identify the spinous process of at the appropriate lumbar level, then it will be scanned laterally about 2-3 cm until visualization of the paraspinal muscles and the transverse process at the same time. After standard sterilization, a 21-G short bevel nerve block needle will be advanced in a cephalad-to-caudal direction, in-plane under real- time ultrasound guidance, through skin, subcutaneous tissue, and erector spinae muscles until reaching the transverse process. After negative aspiration of blood or cerebral spinal fluid, a small volume of local anesthetic was injected to confirm the position of the needle tip between the erector spinae muscles and the transverse process. A total of 20 ml of 0.0.25% plain bupivacaine will be incrementally injected with intermittent negative aspiration on each side.
15783400|NCT04586257|Procedure|Throacolumbar interfacial plane block|USG-guided TLIP block will be performed using a high-frequency linear probe while the patient in prone position. The probe will be covered with sterile sheath positioned transversally in a midline position at approximately the level of the 3rd lumbar vertebra (L3). The corresponding spinous process and interspinal muscles will be identified, and the probe will be slid laterally to identify the multifidus (MF) muscle and longissimus (LG) muscle. Sliding the probe from midline to laterally helps in the correct identification of various muscles. After identifying the muscles, TLIP block will be performed aseptically on both sides of L3 vertebra. Under ultrasound guidance, an insulated echogenic needle will be inserted in-plane in a lateral to medial orientation in-plane USG guided through the belly of LG toward the MF. When needle reach deep to middle of MF/LG interface, 20 ml 0.25% bupivacaine will be injected after negative aspiration. The block will be administered bilaterally.
15783401|NCT04586244|Drug|retifanlimab|retifanlimab will be administered IV over 30 minutes (+ 15 min) on Day 1 of each 28-day cycle, up to 3 cycles
15783402|NCT04586244|Drug|epacadostat|epacadostat will be administered daily twice daily orally up to and including day of surgery.
15783406|NCT04586218|Behavioral|Computer guided vasopressor infusion|automated titration of vasopressor infusion to maintain a mean arterial pressure > 65mmHg
15783407|NCT04586218|Behavioral|Manual control of vasopressor infusion|manual adjustments of noradrenaline infusion
15783408|NCT04586192|Other|Common Elements Toolbox- Adult version (COMET-A)|COMET includes four different modules that teach participants exercises designed to improve mental health and well-being. Participants are asked to complete exercises focused on behavioral activation, cognitive restructuring, gratitude and self-compassion. At the end of the intervention, participants are sent templates that they can you to complete the exercises on, and are encouraged to continue practicing their exercises in their daily life.
15783409|NCT04586192|Other|Self-awareness Control|A control condition in which participants learn about self-awareness through writing about memories, writing a short argumentative essay, and noticing objects in their surroundings.
15783410|NCT04586179|Other|Aerobic (treadmill) Exercise|"Individuals begin walking at 5.8 km/hr. (3.6 mph) at a 0.0% incline (5.1 km/hr. [3.2 mph] if below 5' 10 tall), the treadmill incline is increased 1 degree each minute for the first 15 minutes, then speed increased 0.64 km/hr. (0.4 mph) each minute thereafter.
~Exercise will be terminated if participant a) attains 90 percent of predicted heart rate reserve (HRR=.90*[{208-(.7*age)}-resting HR]), or b) reports a symptom worsening of 3 or points (0-10 scale) for headache, dizziness, or nausea, d) a rapid progression of complaints with continued exercise, or e) a rating of perceived exertion (RPE) greater than 18.5."
15783411|NCT04586179|Other|Dynamic (Agility) Exercise|"Participants will begin in a center circle with equidistant cones 2.5 meters away. After the administrator presents a card, the participant touches a corresponding cone and returns to the starting position. Cards will be presented in increasing frequency in synchrony with a metronome application until exercise termination criteria are identified.
~Exercise will be terminated if participant a) attains 90 percent of predicted heart rate reserve (HRR=.90*[{208-(.7*age)}-resting HR]), or b) reports a symptom worsening of 3 or points (0-10 scale) for headache, dizziness, or nausea, d) a rapid progression of complaints with continued exercise, or e) a rating of perceived exertion greater than 18.5."
15783412|NCT04586166|Device|RP Sling|Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure.
15783413|NCT04586166|Device|SIS|Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure.
15783414|NCT04586153|Drug|Meplazumab for Injection|humanized antibody target CD147
15783415|NCT04586153|Drug|Sterile normal saline (0.9%)|Sterile normal saline (0.9%)
15783416|NCT04586127|Other|AYA NA-SB Questionnaire|Questionnaire identifying cancer needs so that providers can connect subjects with services that might address them.
15783417|NCT04586114|Drug|Corticosteroids and Derivatives|Any systemic corticosteroid treatment administrated during ICU stay
15783418|NCT04586101|Device|Trainings application|Participants have to train with the developed trainings application over six weeks. For this, individual training plans are implemented in the application based on orthopedic joint status and training recommendations of a sports scientist.
15783419|NCT04586088|Drug|Apatinib plus Camrelizumab|Subjects receive Apatinib, 250mg, QD and Camrelizumab, 200mg, D1, Q3W. Treatment was continued until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or investigator decision.
15783420|NCT04586075|Diagnostic Test|Trio Whole Genome Sequencing and Participant-Specific Research|"The initial evaluation begins with short-read genome sequencing of DNA extracted from blood of affected individual(s) and participating family members (The most common approach will be trio whole genome sequencing, which involves the affected child + their parents).
~Additional evaluation may include: functional assessments, animal modeling, reverse phenotyping (may require an interim visit), epigenetic profiling, or clinical database matching through selective sharing of coded patient data with external collaborators (e.g., via Matchmaker Exchange and Phenome Central), long read genome sequencing, de novo genome assembly, RNA sequencing, and novel bioinformatics analyses"
15783421|NCT04586062|Drug|Plasminogen|Human Plasminogen
15783425|NCT04586036|Other|ankle joint brace 1|The influence of ankle joint brace 1 on gait biomechanics
15783426|NCT04586036|Other|ankle joint brace 2|The influence of ankle joint brace 2 on gait biomechanics
15783427|NCT04586036|Other|ankle joint brace 3|The influence of ankle joint brace 3 on gait biomechanics
15783428|NCT04586036|Other|ankle joint brace 4|The influence of ankle joint brace 4 on gait biomechanics
15783429|NCT04586036|Other|ankle joint brace 5|The influence of ankle joint brace 5 on gait biomechanics
15783430|NCT04586023|Drug|fenebrutinib|Participants will receive fenebrutinib.
15783431|NCT04586023|Drug|teriflunomide|Participants will receive teriflunomide.
15783432|NCT04586023|Drug|placebo|Participants will receive teriflunomide-matching placebo or fenebrutinib-matching placebo.
15783433|NCT04586010|Drug|fenebrutinib|Participants will receive fenebrutinib.
15783434|NCT04586010|Drug|teriflunomide|Participants will receive teriflunomide.
15783435|NCT04586010|Drug|placebo|Participants will receive teriflunomide-matching placebo or fenebrutinib-matching placebo.
15783436|NCT04585997|Drug|Mepolizumab|Mepolizumab 100mg subcutaneous injection monthly for 6 months
15783437|NCT04585997|Drug|Omalizumab|Omalizumab subcutaneous injection every 2-4 weeks (dosage determined by the Omalizumab nomogram).
15783438|NCT04585984|Dietary Supplement|Experimental - Probiotic|Patients in the experimental group will take one compound (pill) a day for 21 days, containing a 50% combination of two probiotics: Lactobacillus rhamnosus and Bifidobacterium longum, at a dose of 10^9 cfu/day. The carrier of lyophilized probiotics is maltodextrin and the mixture is encapsulated in hypromellose capsules.
15783439|NCT04585984|Dietary Supplement|Placebo|Patients in the control group will take one unit of placebo a day for 21 days.
15783440|NCT04585971|Diagnostic Test|Signal intensity gradient|"Signal intensity gradient:
~In time-of-flight (TOF) MRA, The signal intensities at the iso-point (Φa; signal intensity at position A [Xa] along the arterial contour line) and at the inner point (Φb; signal intensity at position B [Xb]) were calculated by using a trilinear interpolation algorithm based on the positions and signal intensities in the eight neighboring voxels. The signal intensities of TOF-MRA were normalized to eliminate the offset and scale effects across the MRA datasets of participants. For each iso-point (position A), the SIG was calculated from the difference in signal intensities between points A and B as follows:
~Scalar SIG, SI/mm = (Φb - Φa) / │Xb - Xa│ (1)
~Vector SIG, SI/mm = (Φb - Φa) n / │Xb - Xa│ (2)"
15783441|NCT04585958|Drug|Olaparib|Given PO
15783442|NCT04585958|Biological|Trastuzumab Deruxtecan|Given IV
15783443|NCT04585945|Diagnostic Test|Positive for SARS-CoV-2 infection|Patients that have a positive test for SARS-CoV-2 infection during pregnancy, including at the time of delivery.
15783444|NCT04585932|Drug|Apalutamide|Given PO
15783445|NCT04585932|Drug|Degarelix|Given SC
15783446|NCT04585932|Drug|Leuprolide Acetate|Given IM
15783447|NCT04585932|Other|Quality-of-Life Assessment|Ancillary studies
15783448|NCT04585932|Other|Questionnaire Administration|Ancillary studies
15783449|NCT04585932|Radiation|Radiation Therapy|Undergo RT
15783450|NCT04585919|Behavioral|Paired Screening Intervention|The intervention is the implementation of a paired outreach strategy to patients in need of colorectal cancer screening to offer FIT testing and to complete screening for social determinants of health. These screening activities are part of routine practice but the intervention that is being implemented is the paired outreach for both CRC screening and SDOH screening.
15783451|NCT04585906|Behavioral|Common Elements Treatment Approach|The intervention integrates psychoeducation and addresses safety (when identified as a problem area). It can also include teaching relaxation, cognitive coping, exposure-trauma memories, exposure-live, cognitive restructuring, behavioral activation, and problem solving.
15783452|NCT04585893|Drug|Rituximab|375 mg/m^2 administered via IV infusion weekly for four weeks. Administered via slow IV infusion, starting at 50mg/hr and increasing by 50mg/hr every 30 minutes to a maximum infusion rate of 400mg/hr.
15783453|NCT04585893|Drug|Etoposide|Subjects with high-risk disease will receive 100 mg/m^2 etoposide weekly for four weeks administered over one hour via IV infusion after completion of rituximab
15783454|NCT04585880|Other|Virtual Collaborative Care Clinic|The vCCC will operate under a collaborative care agreement with the Primary Care Physicians as an extension (and not a replacement) of their care. Trained clinical pharmacists will monitor blood pressure and prescribe and adjust medications under the license of, and in communication with, the patient's Primary Care Physician. As part of the Primary Care Physician's team and per Primary Care Physician's directions, the pharmacists may coordinate blood pressure management with other clinicians such as cardiologists or nephrologists co-managing patients blood pressure.
15783455|NCT04585867|Drug|Exparel|The injections will be performed under direct guidance by the cardiac surgeon at bilateral sternal-costal interspaces 1.5 cm lateral the sternal boarder at levels 2-6 in divided doses (2 ml/injection) just before the closure of the sternum near the end of the surgical procedure. The final 20 ml will be injected into the skin incision after closure
15783456|NCT04585867|Drug|Bupivacaine|The injections will be performed under direct guidance by the cardiac surgeon at bilateral sternal-costal interspaces 1.5 cm lateral the sternal boarder at levels 2-6 in divided doses (2 ml/injection) just before the closure of the sternum near the end of the surgical procedure. The final 20 ml will be injected into the skin incision after closure
15783458|NCT04585841|Drug|Cannabidiol|Patients will receive cannabidiol in the period of time they receive chemotherapy.
15783459|NCT04585828|Device|Phototherapy with double sided fiber optic pads with blue light at irradiance 30 uW/cm2/nm using Bili Cocoon|The baby will be treated with Bilicocoon for 24 hours. Decrease of total serum biliurubin will be evalueated hereafter.
15783460|NCT04585828|Device|Phototherapy from above using NeoBlue at irradiance of 30 uW/cm2/nm|The baby will be treated with phototherapy from above for 24 hours. Decrease of total serum bilirubin will be evaluated hereafter.
15783461|NCT04585815|Drug|Sasanlimab Prefillled syringe|prefilled syringe
15783462|NCT04585815|Drug|Encorafenib|capsules
15783463|NCT04585815|Drug|Binimetinib|tablets
15783464|NCT04585815|Drug|Sasanlimab|solution supplied in vials
15783465|NCT04585815|Drug|Axitinib|tablets
15783466|NCT04585815|Drug|SEA-TGT|solution in vials
15783467|NCT04585789|Drug|JNJ-73763989|JNJ-73763989 will be administered subcutaneously once every 4 weeks up to Week 44.
15783468|NCT04585789|Drug|JNJ-56136379|JNJ-56136379 tablets will be administered orally once daily up to 48 weeks.
15783469|NCT04585789|Drug|Entecavir (ETV)|ETV tablet will be administered orally once daily up to 48 weeks as NA treatment.
15783470|NCT04585789|Drug|Tenofovir disoproxil|Tenofovir disoproxil will be administered orally once daily up to 48 weeks as NA treatment.
15783471|NCT04585789|Drug|Tenofovir alafenamide (TAF)|TAF will be administered orally once daily up to 48 weeks as NA treatment.
15783472|NCT04585789|Drug|PegIFN-alpha-2a|PegIFN-alpha-2a injection will be administered subcutaneously once weekly after Week 40 for either 12 or 24 weeks.
15783473|NCT04585776|Drug|LY900014|Administered SC
15783474|NCT04585776|Drug|Insulin Degludec|Administered SC
15783475|NCT04585763|Device|Shockwave Medical M5+ Peripheral Intravascular Lithotripsy (IVL)|The Shockwave Medical M5+ Peripheral IVL System is indicated for lithotripsy-enhanced, low-pressure balloon dilatation of lesions, including calcified lesions, in the peripheral vasculature, including the iliac, femoral, ilio-femoral, popliteal, infra-popliteal, and renal arteries. This device is not intended for use in coronary, carotid, or cerebrovascular arteries.
15783476|NCT04585750|Drug|PC14586|PC14586 is a first-in-class, oral, small molecule p53 reactivator that is selective for the p53 Y220C mutation, being developed for the treatment of patients with advanced solid tumors harboring a p53 Y220C mutation. PC14586 will be administered orally on a continuous regimen.
15783477|NCT04585737|Drug|Dolutegravir / Lamivudine Pill|Experimental
15783478|NCT04585737|Drug|Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill|Active comparator
15783483|NCT04585711|Drug|Etanercept Optimal dosing|Patients will receive Etanercept on an optimal dose interval over a 6-week period based on a PK/PD model.
15783486|NCT04585672|Other|Ammonia infusion|Ammonia metabolism investigated in healthy individuals and patients with cirrhosis with and without ammonia lowering agent: glycerolphenylbutyrat (healthy) and Lactulose + Rifaximin (Cirrhosis)
15783487|NCT04585659|Other|Qigong|Mind-body movement art that includes specific movements, breath exercises, stretching and meditation.
15783488|NCT04585633|Other|Quality of Recovery-15|Quality of Recovery-15 is a scale consisting of 15 questions indicating the recovery quality of the patient after anesthesia and a score between 0-150.
15783489|NCT04585633|Other|Glasgow Result Scale|Glasgow Outcome Scale; It is a scale developed to categorize people suffering from head trauma or non-traumatic acute brain injury into broad outcome categories. It shows postoperative mortality and morbidity of patients who underwent intracranial surgery.
15783490|NCT04585633|Other|Risk Factors|Pre-operative: medical histories, drugs used, demographic features, additional diseases, ASA class, pre-operative routine parameters, operation history, GCS, tumor histology, location, dimensions and intracerebral radiological data, laboratory values Intraoperative; hemodynamic data of patients; highest and lowest values of heart rate, diastolic, systolic and mean arterial pressures, fluid and blood products given, anesthetic and other drugs administered, duration of anesthesia, duration of surgery, surgical position, blood loss, urine output and blood gas samples Post-operation; extubation time, MAS score, use of mechanical ventilation, post-operative complications, hemodynamic data, blood gas data
15783491|NCT04585620|Drug|Onabotulinum Toxin A|Series of subcutaneous injections
15783492|NCT04585620|Drug|Normal saline|Series of subcutaneous injections
15783493|NCT04585607|Device|A medium cut-off dialyzer (Theranova) will be used for HDx.|"A medium cut-off dialyzer used for HDx (Theranova) must be implemented following current clinical practices guidelines and procedures at the hospital. No additional actions are required. General rules will be applied regarding dialysis prescription.
~HD with MCO dialyzer (Theranova 400®, Baxter) vs. high-flux dialyzer (eg. Polyflux H, Baxter)"
15783494|NCT04585607|Device|A synthetic high-flux dialyzer (Polyflux)|A synthetic high-flux dialyzer (Polyflux) used for hemodialysis must be implemented following current clinical practices guidelines and procedures at the hospital. No additional actions are required.
15783584|NCT04584957|Device|VAC therapy|Prophylactic ciNPWT therapy (Prevena® KCI) entails placement of the device over a closed incision immediately post-operatively. Prevena® KCI may be left in place with no additional intervention for up to 7 days.
15783618|NCT04584684|Drug|0.075% Cetylpyridinium Chloride|Over-the-counter antiseptic mouth rinse
15783619|NCT04584684|Other|Saline|Saline placebo rinse
15783923|NCT04582032|Drug|Saline (Isotonic Saline Solution 0.9% )|intravenous 2 ml of saline
15783495|NCT04585594|Behavioral|Mi Propio Camino (MPC)|The Mi Propio Camino (MPC) intervention will be comprised of four sessions. Session 1 will encompass: the facts about high blood pressure (BP), understanding blood pressure readings, provide an overview of changes one can make to manage their BP, introduce MPC personal experience monitoring, and usage the mHealth kit. Subsequently, sessions 2-4 will emphasize the benefits of personal experience monitoring through 1) personal insight (finding what works for them) and 2) empowerment to work with their providers. Session 2 will reinforce this by introducing: synergy between medication and lifestyle, principles of heart-healthy eating and physical activity. Session 3 will incorporate discussion of negative beliefs about medication and patient directed lifestyle learning-rotating stations. Lastly, session 4 will introduce the continuation of personal experience monitoring on their own through the use of behavioral strategies for adherence and provider communication strategies.
15783496|NCT04585594|Behavioral|Habilidades para Controlar la Presion (HCP; Skills for Blood Pressure Control)|The HCP intervention will be comprised of four sessions and introduce seven lifestyle strategies (LS) subdivided per these sessions. Session 1 will encompass the facts about high blood pressure (BP), understanding blood pressure readings, provide an overview of changes one can make to manage their BP, present specific health threats from high BP, and incorporate LS1: taking control of your medication. Subsequently, sessions 2-4 will reinforce the benefits of taking medications through presenting 1) reduced risk for complications and 2) strategies to remember to take medications. Session 2 will present LS2: eating a well-balanced, low-salt diet and LS3: enjoying regular physical activity. Session 3 will follow with introducing LS4: maintaining a healthy weight and LS5: shaking the salt habit while eating out. Session 4 will present LS6: managing stress and LS7: working together with their doctor followed by a review of strategies they can continue on their own.
15783497|NCT04585581|Behavioral|time-restricted eating|Participants will be asked to limit the time-window for their daily energy intake to a maximum of 10 hours.
15783498|NCT04585581|Behavioral|high intensity exercise|Participants will be encouraged to exercise with high intensity 2-3 times per week
15783499|NCT04585581|Other|Standard Care|Standard clinical care
15783500|NCT04585568|Other|Biosensors|Measures of blood flow and preassures
15783501|NCT04585555|Device|Accuryn Monitoring System|The Accuryn Monitoring System is a novel Foley catheter and monitoring device capable of detecting physiologic changes in vital signs via sensors within the catheter system. These data are captured non-invasively, continuously, and at a high frequency.
15783502|NCT04585542|Drug|Polyethylene Glycol 3350|Nonspecific laxative comparison group.
15783503|NCT04585542|Drug|Sodium Polystyrene Sulfonate Oral Suspension [SPS]|Potassium binder to treat hyperkalemia.
15783504|NCT04585542|Drug|Patiromer|Potassium binder to treat hyperkalemia.
15783505|NCT04585542|Drug|Sodium zirconium cyclosilicate|Potassium binder to treat hyperkalemia.
15783506|NCT04585516|Procedure|endoscopy|Colonoscopy or gastroscopy
15783507|NCT04585503|Device|Electrode implantation|The intervention consist in implanting 6 electrodes in subdural or intra cortical position and monitor the central nervous system activity. This monitoring will be additional to the usual monitoring.
15783508|NCT04585490|Drug|Durvalumab|Cohort 1 (1500 mg IV every 21 days, for 1 year), •Cohort 2 (10mg/kg every 2 weeks for 1 year)
15783509|NCT04585490|Drug|Carboplatin|Target area under the curve (AUC) not to exceed 750mg on Day 1 of every 21-day cycle
15783510|NCT04585490|Drug|Pemetrexed|500mg/m2 on Day 1 of every 21-day cycle
15783511|NCT04585490|Drug|Paclitaxel|175mg/m2 on Day 1 of every 21-day cycle
15783512|NCT04585490|Drug|Cisplatin|Cisplatin (75mg/m2 per institution guidelines) may be substituted for Carboplatin
15783513|NCT04585490|Device|AVENIO ctDNA Surveillance Kit|Roche Sequencing and Life Science kit to detect minimal residue disease (MRD)
15783514|NCT04585477|Device|AVENIO ctDNA Surveillance Kit|Roche Sequencing and Life Science kit to detect minimal residue disease (MRD)
15783515|NCT04585477|Drug|Durvalumab|1500mg intravenous dose or 20mg/kg if weight is 30kg or less, manufactured by AstraZeneca
15783516|NCT04585464|Drug|EDG-5506|EDG-5506 is administered orally as a single dose or once daily
15783517|NCT04585464|Drug|Placebo|Placebo is administered orally as a single dose or once daily
15783518|NCT04585451|Diagnostic Test|ALGOS System|A Quantitative Electroencephalography (QEEG) based pain biomarker assessment that scales with patient reported Numeric Rating Scale (NRS)
15783519|NCT04585438|Drug|Diclofenac Potassium|The drug will be used as a transparent disc applied to the mucosa
15783520|NCT04585425|Behavioral|Sleep hygiene advice|Participants receive standard sleep hygiene advice.
15783521|NCT04585425|Behavioral|Bedtime music listening|Participants in the intervention group listen to their preferred sleep playlist daily at bedtime for minimum 30 minutes.
15783522|NCT04585412|Drug|Palonosetron|Pharmacokinetic study under fasting conditions
15783523|NCT04585399|Behavioral|Contingency management|Financial incentives for attending bup appointments and demonstrating opioid abstinence. Rides will also be provided for up to two clinic visits per week.
15783524|NCT04585386|Other|Visual analog scale|to measure the lumbar and radicular pain felt by the patient.
15783525|NCT04585386|Other|Mac Gill Pain Questionnaire|self-questionnaire that allows a qualitative assessment of chronic pain
15783526|NCT04585386|Other|Roland and Morris Disability Questionnaire|functional disability scale for assessing low back pain
15783527|NCT04585386|Other|Quebec questionnaire|To access the patient's perception of incapacity
15783528|NCT04585373|Other|kinesio-taping with conventional therapy 24 hours|"standardized therapeutic KT application along with conventional therapy (hot pack ,strengthening and stretching exercises) quadriceps tapping: In the supine position, the Y shape tape will be applied from the middle of the thigh to the upper edge of the patella, Then, the tape will anchored to the inner and outer aspect of the patella with 25% muscle tension and the distal end of the strips are positioned on the tibial tubercle without any tension.
~McConnell Patellar tapping technique:
~The patient will be positioned in long sitting position; affected knee joint exposed. As per McConnell patellar taping technique, tape will applied from superior and lateral patellar borders, maximally pulling it medially. A second strip can be used for reinforcement, but it should not cover the popliteal fossa."
15783614|NCT04584684|Drug|1.5% w/v Hydrogen Peroxide|Over-the-counter antiseptic mouth rinse antiseptic mouth rinse
15783615|NCT04584684|Drug|0.12% Chlorhexidine Gluconate|Dentist prescribed antimicrobial mouth rinse
15783529|NCT04585373|Other|kinesio-taping with conventional therapy 48 hours|"standardized therapeutic KT application along with conventional therapy (hot pack ,strengthening and stretching exercises) quadriceps tapping: In the supine position, the Y shape tape will be applied from the middle of the thigh to the upper edge of the patella, Then, the tape will anchored to the inner and outer aspect of the patella with 25% muscle tension and the distal end of the strips are positioned on the tibial tubercle without any tension.
~McConnell Patellar tapping technique:
~The patient will be positioned in long sitting position; position; affected knee joint exposed. As per McConnell patellar taping technique, tape will applied from superior and lateral patellar borders, maximally pulling it medially. A second strip can be used for reinforcement, but it should not cover the popliteal fossa."
15783530|NCT04585373|Other|kinesio-taping with conventional therapy 72 hours|"standardized therapeutic KT application along with conventional therapy (hot pack ,strengthening and stretching exercises) quadriceps tapping: In the supine position, the Y shape tape will be applied from the middle of the thigh to the upper edge of the patella, Then, the tape will anchored to the inner and outer aspect of the patella with 25% muscle tension and the distal end of the strips are positioned on the tibial tubercle without any tension.
~McConnell Patellar tapping technique:
~The patient will be positioned in long sitting position; affected knee joint exposed. As per McConnell patellar taping technique, tape will applied from superior and lateral patellar borders, maximally pulling it medially. A second strip can be used for reinforcement, but it should not cover the popliteal fossa."
15783531|NCT04585360|Other|Questionnaires evaluating anxiety and depression symptoms, tiredness, and quality of life|"Realization of specific questionnaires evaluating:
~psychiatric symptoms (self-assessment according to the SLC-90R questionnaire and hetero-assessment by the internist doctor of the center according to the M.I.N.I. questionnaire)
~fatigue (Multidimensional Fatigue Inventory (MFI-20), French version, in self-assessment)
~quality of life (SF36 self-assessment questionnaire)"
15783532|NCT04585347|Drug|ALZ-801 170 mg Fasting|
15783533|NCT04585347|Drug|ALZ-801 205 mg Fasting|
15783534|NCT04585347|Drug|ALZ-801 205 mg After Food|
15783535|NCT04585347|Drug|ALZ-801 342 mg Fasting|
15783536|NCT04585334|Drug|Tricortin 1000|Tricortin 1000 [2 mL ampoules containing 12 mg of phospholipids and 1 mg of Vitamin B12 (Cyanocobalamin)] will be administered intramuscular on the gluteus, once daily (24 hours apart), for 15 days starting from the evening of Day 0 (visit 2) plus Diclofenac sodium medicated plaster placebo will be applied twice daily (12 hours apart) for 15 days starting from the evening of Day 0 (visit 2), i.e. 30 applications.
15783537|NCT04585334|Drug|Itami|Diclofenac sodium 140 mg medicated plaster (Itami®) will be applied twice daily (12 hours apart) for 15 days starting from the evening of Day 0 (visit 2), i.e. 30 applications plus Tricortin 1000 placebo (2 mL ampoules) will be administered intramuscular on the gluteus, once daily (24 hours apart), for 15 days starting from the evening of Day 0 (visit 2).
15783538|NCT04585334|Drug|Placebo|Tricortin 1000 placebo (2 mL ampoules) will be administered intramuscular on the gluteus, once daily (24 hours apart), for 15 days starting from the evening of Day 0 (visit 2) plus Diclofenac sodium medicated plaster placebo will be applied twice daily (12 hours apart) for 15 days starting from the evening of Day 0 (visit 2), i.e. 30 applications.
15783539|NCT04585321|Drug|Diclofenac Sodium 140mg Medicated Plaster|"Part 1: two seven-day study periods, separated by at least 7 days of wash-out. In the first period, a single plaster of Test Drug or Reference Drug will be applied on the back (lumbar region) for seven consecutive days. In the second period, a single plaster of the Reference Drug or Test Drug will be applied on the back (lumbar region) daily for seven consecutive days.
~Part 2: two seven-day study periods separated by at least 7 days of wash-out. In the first period, the Test Drug or Reference Drug plaster will be applied on the back (lumbar region) twice a day. In the second period, the Reference Drug or Test Drug plaster will be applied on the back (lumbar region) twice a day."
15783540|NCT04585321|Drug|Flector® topical plaster containing 180 mg of diclofenac hydroxyethylpyrrolidine equivalent to 140 mg of sodium diclofenac|"Part 1: two seven-day study periods, separated by at least 7 days of wash-out. In the first period, a single plaster of Test Drug or Reference Drug will be applied on the back (lumbar region) for seven consecutive days. In the second period, a single plaster of the Reference Drug or Test Drug will be applied on the back (lumbar region) daily for seven consecutive days.
~Part 2: two seven-day study periods separated by at least 7 days of wash-out. In the first period, the Test Drug or Reference Drug plaster will be applied on the back (lumbar region) twice a day. In the second period, the Reference Drug or Test Drug plaster will be applied on the back (lumbar region) twice a day."
15783541|NCT04585308|Device|transShield Embolic Protection System|Used for embolic protection during TAVR.
15783542|NCT04585295|Dietary Supplement|Betaine|50 mg/kg Betaine consumed twice daily for 7 days.
15783543|NCT04585295|Dietary Supplement|BCAA Big 6|1 level scoop (~18 g) of NOW Foods BCAA Big 6, consumed once per day for 7 days.
15783544|NCT04585295|Dietary Supplement|Placebo|50 mg/kg Placebo consumed twice daily for 7 days.
15783545|NCT04585282|Behavioral|Plus Cognitive behavioral therapy of insomnia（CBT-I plus）|Cbt-i plus program is an enhanced version of cbt-i program, which increases the response to depression and anxiety symptoms.
15783546|NCT04585282|Behavioral|Cognitive behavioral therapy of insomnia（CBT-I）|Cognitive behavioral therapy of insomnia is mainly aimed at correcting the bad behaviors and beliefs among the maintenance factors of insomnia, which is considered as the first-line treatment program of insomnia disorder. Cognitive behavioral therapy of insomnia mainly includes five important components: sleep restriction, secondary control, cognitive therapy, relaxation therapy and sleep hygiene.
15783547|NCT04585269|Behavioral|Bright IDEAS-YA|Bright IDEAS-YA is a manualized problem-solving skills training intervention conducted by a trainer who teaches the participant the Bright IDEAS stepwise approach to problem-solving and guides the participant through solving their own problems using the Bright IDEAS approach.
15783548|NCT04585256|Other|Trendelenburg positioning|Women positioned in the trendelenburg position prior to external cephalic version
15783549|NCT04585243|Device|Evalyn Brush|The Evalyn Brush is a self-sampling kit that can be used to collect a sample to screen for HPV/Cervical cancer at home.
15783550|NCT04585230|Drug|CBD|CBD oil Roll-On Stick
15783551|NCT04585230|Drug|Mineral Oil|Mineral Oil- Roll on Stick
15783552|NCT04585230|Drug|Placebo|Roll- On stick with no CBD and no Mineral Oil
15783616|NCT04584684|Drug|27% Ethanol plus essential oils|Over-the-counter antiseptic mouth rinse
15783553|NCT04585217|Procedure|Different suture materials for closure (6-0 polypropylene monofilament suture versus fast absorbing gut suture)|"Plain gut suture (6-0 fast absorbing plain gut [Sharpoint Express gut TM]) and polypropylene suture (6-0 polypropylene [Ethicon Prolene TM]) will be used to close blepharoplasty incisions. Each patient will have one eyelid using plain gut suture and the other eyelid with polypropylene suture. A randomized block design will be used to randomize eyelids to suture types. Blocks of 10 patients will be used. Each block will have 5 right eyelids with plain gut suture, 5 right eyelids with polypropylene suture, 5 left eyelids with plain gut suture, and 5 left eyelids with polypropylene suture."
15783554|NCT04585204|Diagnostic Test|Oral glucose tolerance test|Oral glucose tolerance test
15783555|NCT04585191|Behavioral|Conversation Aid|"Intervention is a newly developed, 1-page conversation aid/communication tool entitled Talking to Your Doctor about Diabetes: Are My Current Medicines Still Right for Me? that patients receive prior to a scheduled appointment with their PCP. This document will provide brief education about changing risks and benefits of diabetes treatment as patients age, elicit values and preferences regarding treatment, and help direct next conversation steps."
15783556|NCT04585191|Other|Attention Control Educational Handout|Attention control is an existing health education handout that provides some general health advice geared towards older patients.
15783557|NCT04585152|Drug|Rituximab Biosimilar|for dosage between 100 and 250 mg Rituximab will be diluted in 100 ml of normal saline and administered at 2 ml/h for the first 30'; 3 ml/h for the second 30'; 6 ml/h for the third 30'; 15 ml/h until the end. For dosage between 260 and 500 mg Rituximab will be diluted in 250 ml of normal saline and administered at 6 ml/h for the first 30'; 9 ml/h for the second 30'; 18 ml/h for the third 30'; 36 ml/h until the end. For dosage between 510 and 1000 mg Rituximab will be diluted in 500 ml of normal saline and administered at 9 ml/h for the first 30'; thereafter, the infusion rate can be doubled every 30 minutes up to a maximum of 72 ml/h.
15783558|NCT04585139|Device|Phase 1- Introduction to Dexcom G6 CGM|Examine whether non-adjunctive use of CGM improves glycemic control in adults with diabetes managed by intensive insulin therapy
15783559|NCT04585126|Drug|Intermediate cervical block|Local anesthesia performed in addition to the general anesthesia
15783560|NCT04585113|Radiation|CT-scanning|All participants will receive dual-energy CT scanning and cone-beam CT scanning prior surgery.
15783561|NCT04585100|Drug|FM101 tablet|Bio-equivalent test (tablet vs oral solution)
15783562|NCT04585100|Drug|FM101 oral solution|Bio-equivalent test (tablet vs oral solution)
15783563|NCT04585100|Drug|Placebo|Placebo BID for 28 days
15783564|NCT04585100|Drug|FM101 150 mg|FM101 (150 mg) BID for 28 days
15783565|NCT04585100|Drug|FM101 300 mg|FM101 (300 mg) BID for 28 days
15783567|NCT04585074|Procedure|Robotic or endoscopic nipple sparing mastectomy|Cases or Patients who underwent robotic nipple-sparing mastectomy and immediate reconstruction are enrolled in this arm. Robotic nipple-sparing mastectomy should be performed using robotic surgical systems. Robotic surgical systems include da Vinci S,Si, X, Xi, and SP systems. Axillary or lateral incisions are used for this procedure. Immediate reconstruction includes tissue expander insertion, direct-to-implant, latissimus dorsi flap, transverse abdominis rectus muscle flap, or deep inferior epigastric perforators flap. Cases with robotic mastectomy without immediate reconstruction are excluded.
15783568|NCT04585074|Procedure|Conventional mastectomy (including nipple sparing mastectomy, skin sparing mastectomy)|Cases or Patients who underwent conventional mastectomy and immediate reconstruction are enrolled in this arm. Conventional mastectomy should not be performed using robotic or endoscopic surgical systems. Any incisions can be performed for this procedure. Conventional mastectomy includes also Nipple-sparing mastectomy and Skin sparing mastectomy. Immediate reconstruction includes tissue expander insertion, direct-to-implant, latissimus dorsi flap, transverse abdominis rectus muscle flap, or deep inferior epigastric perforators flap. Cases without immediate reconstruction are excluded.
15783569|NCT04585061|Drug|Lidocaine Hydrochloride|1.8ml of 2%Lidocaine HCl to be administered via a 21mm needle
15783570|NCT04585061|Device|Virtual reality device (Harga Miniso Vr Glass 3d terbaru)|"Virtual reality device (Harga Miniso Vr Glass 3d terbaru) is placed on the face of the patient, playing a video of Tom and Jerry cartoon.
~Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized"
15783571|NCT04585061|Dietary Supplement|Xylitol|Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized while xylatol tablet putted under tongue
15783572|NCT04585048|Behavioral|Integrated Behavioral Therapy for Selective Mutism|Cognitive Behavioral treatment including 24 weekly sessions
15783575|NCT04585022|Device|Magnum, Zimmer Biomet, Warsaw, IN|
15783576|NCT04585022|Device|Recap, Zimmer Biomet, Warsaw, IN|
15783577|NCT04585009|Drug|GSK3923868|GSK3923868 will be available as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.
15783578|NCT04585009|Drug|Matching placebo|Placebo to match GSK3923868 will be available as capsule containing inhalation powder to be delivered via Monodose RS01 device.
15783579|NCT04585009|Device|Monodose RS01|Participants will receive GSK3923868 and placebo as capsules containing inhalation powder blend to be delivered via Monodose RS01 device.
15783580|NCT04584983|Drug|usual prescribed intralipid (UL) regimen|Intralipid will be started at 1 g/kg/day and routinely advanced by 1 g/kg/day each day to a max of 3 g/kg/day as per usual clinical practice
15783581|NCT04584983|Drug|restricted prescribed intralipid (RL) regimen|Intralipid will be started at 0.5 g/kg/day and routinely advanced by 0.5 g/kg/day each day to a max of 1.5 g/kg/day (half rate of usual clinical practice).
15783582|NCT04584970|Device|Applied VR|The Applied VR device is a lightweight mobile virtual reality headset with embedded software, creating an immersive experience. The Applied VR is specifically designed for medical use.
15783583|NCT04584970|Device|Apple iPad|The Apple iPad is a tablet device controlled by touch screen with a variety of games and applications.
15783585|NCT04584944|Radiation|Dual energy X-ray absorptiometry|"Evaluation of the appendicular muscle mass of the limbs will be performed by Dual-Energy X-ray Absorptiometry, using a QDR 4500. Body composition analysis will also be evaluated with TANITA Body Composition Analyzer device,model BC-418MA. Bioelectrical Impedance Analysis measures the body composition using a constant power source (high frequency current 50kHz, 90 μA).
~Muscle mass is also going to be measured by using ultrasound -U/S. It measures basic parameters such as muscle volume and spectrum length through the B-Mode imaging with Linear 7-12MHz frequency heads that can reliably determine the thickness and transverse incisions of the superficial muscular Groups."
15783586|NCT04584931|Procedure|coronally advanced flap|flap surgery to achieve root coverage at gingival recession defect
15783587|NCT04584931|Procedure|restorative intervention|colored composite restoration to camouflage the gingival recession defect
15783588|NCT04584905|Dietary Supplement|dietary supplements for CKD patients|follow up and assessment of nutritional status of CKD patients
15783590|NCT04584879|Behavioral|Standard UP Treatment|Participants will receive treatment modules sequenced in accordance with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP; Barlow et al 2011; 2018).
15783591|NCT04584879|Behavioral|Capitalization UP Treatment|Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that capitalize on patient strengths.
15783592|NCT04584879|Behavioral|Compensation UP Treatment|Participants will receive Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (UP) treatment modules organized to prioritize skills that compensate for patient weaknesses.
15783593|NCT04584866|Procedure|Endonasal endoscopic pituitary surgery in semi-sitting position|Patients will be placed in semi-sitting position. To achieve the semi-sitting position, the patient is placed in supine position. The operating table is then separated and flexed to elevate the torso (angle of 30°). The head, which is fixed in a head clamp, is slightly flexed to bring the floor of the sella right in front of the surgeon and gently rotated toward the operating team.
15783594|NCT04584866|Procedure|Endonasal endoscopic pituitary surgery in supine position|Patients will be operated in the standard supine neutral position
15783595|NCT04584853|Drug|Abemaciclib|Abemaciclib used in combination with standard Endocrine Therapy for 2 years from randomisation
15783596|NCT04584853|Drug|Endocrine therapy|Standard of care endocrine therapy for a minimum of 5 years from randomisation
15783597|NCT04584840|Procedure|Surgical treatment|"Same guidelines as group 1 (non-surgical) plus surgical treatment according to the following protocol:
~Specific protocol for surgical treatment
~Wide mucoperiosteal flaps and complete surgical excision of necrotic bone together with a mucosa margin of at least 2 mm.
~Removal of dental pieces included in the diseased area and regularization of bony margins avoiding leaving sharp edges or spicules.
~Secure a two layered waterproof closure without tension (simple or with local flaps).
~Samples will be sent for Pathological and microbiological analysis.
~Stitches removal after two weeks
~Postoperative systemic antibiotic following the mentioned protocol until stitches removal."
15783598|NCT04584827|Other|lactate level|Lactate, a byproduct of glycolysis, is an indicator of weak tissue perfusion and a useful biomarker with prognostic value in various diseases. Lactate value is calculated by blood gas.
15783599|NCT04584827|Other|Glasgow Outcome Scale|Glasgow Outcome Scale; It is a scale developed to categorize people suffering from head trauma or non-traumatic acute brain injury into broad outcome categories. It shows postoperative mortality and morbidity of patients who underwent intracranial surgery.
15783600|NCT04584814|Device|No intervention|Basal analysis
15783601|NCT04584814|Device|scare ventilator at 20|To set scare ventilator by 20 cycles per minute
15783602|NCT04584814|Device|scare ventilator at 40|To set scare ventilator by 40 cycles per minute
15783603|NCT04584801|Diagnostic Test|Structured Light Plethysmography|"Part A: Subjects will have two 5-minute SLP measurements (Pre and Post bronchodilator).
~Part B: Subjects will be seen in the clinics and have three 5-minute SLP measurements (pre-bronchodilator, post-bronchodilator and post spirometry testing)."
15783604|NCT04584775|Other|Treatment modalities of Traditional Chinese Medicine (Acupuncture, Chinese herbal medicine, Tunia, Chinese dietetics)|"Acupuncture is a physical treatment modality that uses thin needles to stimulate specific points on the body in order to manipulate neurologic mechanisms to control specific symptoms and/or physiologic processes.
~Chinese herbal medicine is a phytotherapeutic treatment modality that uses herbs, minerals and rarely animal products which are orally administered.
~Tuina is a form of massage and physical therapy. Chinese dietetics is a nutritional therapy according to the theoretical principle of traditional Chinese medicine."
15783605|NCT04584775|Other|Standard care|Standard care includes any medical intervention in palliative care that aims to promote and/or sustain the quality of life of patients suffering from advanced disease (in this case cancer). These may be of pharmaceutical, surgical, psychological and/or spiritual nature.
15783606|NCT04584762|Device|Automated Variable Pressure Insufflation|Acute migraine treatment
15783607|NCT04584749|Drug|Lidocaine Iv|"2% lidocaine or 0.9% physiological saline will be used as placebo, and it will be administered as a bolus during anesthetic induction equivalent to 1.5 mg / kg of lidocaine. After induction, an intravenous infusion will be started at 0.1 ml / kg / h of the study preparation, equivalent to 2mg / kg / h of lidocaine.
~20 ml syringe for induction and two 50 ml syringes for anesthetic maintenance containing 2% Lidocaine ."
15783608|NCT04584736|Drug|Livalo, Ezetrol|Pitavastatin+Ezetimibe Pitavastatin
15783609|NCT04584723|Other|Observation of flap survival and complications|We will report the flap survival and complications in this population group underwent to microsurgical procedures in a private practice setting
15783610|NCT04584710|Drug|RTB101|Oral RTB101 10 mg hard gelatin capsule once daily for 2 weeks
15783611|NCT04584710|Drug|Placebo|Oral matching placebo once daily for 2 weeks
15783612|NCT04584697|Biological|COVI-AMG|COVI-AMG is a fully human SARS-CoV-2 neutralizing monoclonal antibody (mAb).
15783613|NCT04584697|Drug|Placebo|Diluent solution
15783620|NCT04584671|Diagnostic Test|Hyperpolarized Xenon-129 MRI of the lungs|Participants will be imaged using MRI using hyperpolarized xenon-129 gas as a contrast gas
15783621|NCT04584671|Diagnostic Test|Computed Tomography (CT)|Participants will undergo a CT scan of the thoracic cavity
15783622|NCT04584671|Diagnostic Test|Pulmonary Function Tests (PFT)|Participants will have their lung function evaluated using PFT
15783623|NCT04584671|Diagnostic Test|Six Minute Walk Test (6MWT)|Participants will perform the six minute walk test as a measure of exercise capacity
15783624|NCT04584671|Diagnostic Test|Sputum analysis|Participants will provide a sputum sample that will be analysed for eosinophils
15783625|NCT04584671|Diagnostic Test|Blood analysis|Participants will have their blood drawn and analysed for eosinophil count.
15783626|NCT04584671|Other|Questionnaires|Participants will complete questionnaires to assess activity related dyspnea, respiratory symptoms and health status impairment and respiratory related quality of life.
15783627|NCT04584658|Diagnostic Test|Fibreoptic Endoscopic Evaluation of Swallowing (FEES)|This is the use of endoscopy during feeding trials. The patient is fed different consistencies of food and drink while an endoscope is in place (usually passed through the nasal passage and down into the throat). The endoscope provides a bird's eye view to the transit of food through the upper aero-digestive tract. This provides information from the point of food bolus formation in the mouth to the movement of the base of the tongue; the movement of pharyngeal muscles; the deflection of the epiglottis to protect the airway including the closure of the vocal cords and the passage of food into the oesophagus. Any abnormality in these steps are noted during FEES. Liquids, thickened fluids, semi-solids and solids are some of the food textures that are tested.
15783628|NCT04584658|Diagnostic Test|Videofluoroscopy|A radio opaque dye is used to label the test food and drink items offered to the patient. Following this, x-ray technology is used to create a video of the outline of the patient and the structures responsible for chewing and swallowing as they injest the test materials. The study is carried out in real time in the radiology department in conjunction with a radiographer and an SLT.
15783629|NCT04584658|Other|Dysphagia Handicap Index (DHI)|This is a 25-item questionnaire assessing three domains: physical (9 items), functional (9 items), and emotional aspects (7 items) of the Quality of Life (QOL) in patients suffering with dysphagia. For each statement the patient checks if it applies to him/her all the time, some of the time or never. The suggested scores are 0, 2 and 4, respectively. Using this scoring system amounts to a DHI score range of 0 - 100. The higher the score, the worse the dysphagia related QOL. The patient is also asked to provide a rating of their own impression of the severity of the dysphagia experienced on a scale from 1 (normal) to 7 (severe problem).
15783630|NCT04584658|Other|Voice Symptom Scale (VoiSS)|This is a 30-item validated quality of life tool that is also a self-reporting tool. It appraises the impact of the patient's abnormal voice from an emotional perspective, related physical symptoms and stratifies the impairment itself in context of day to day activities. VoiSS is currently the most psychometrically robust voice outcome measure. Each item is scored 0 - 4 on the frequency responses: never, occasionally, some of the time, most of the time, always. The total score of 120 measures general voice pathology which is made up of Impairment = maximum score of 60; Emotional = maximum score of 32; Physical = maximum score of 28.
15783631|NCT04584645|Other|Targeted digital intervention|Messages that provide informational content on the influenza vaccine (sourced from the Centers for Disease Control and Prevention and the American Heart Association), specific information about influenza and cardiovascular disorders, and behavioral prompts (e.g., reminders) surrounding influenza vaccination behaviors.
15783632|NCT04584632|Device|Efemoral Vascular Scaffold System (EVSS)|Balloon-expandable, bioresorbable vascular scaffolds coated with sirolimus
15783633|NCT04584619|Device|Spine fusion surgery with Clariance Idys TLIF 3DTi|Posterior fusion of the lumbar spine with Clariance Idys TLIF 3DTi interbody fusion device used in conjunction with a posterior fixation system (pedicle screws and rod).
15783634|NCT04584606|Diagnostic Test|Lab workup (on admission and regularly during follow up).|"Complete blood count with differential leucocytic count. Absolute lymphocytic and neutrophilic count. Liver functions: Aspartate transaminase and Alanine transaminase . Renal functions: Blood urea nitrogen, serum Creatinine. HbA1C. C-reactive protein (quantitative). Serum ferritin level. D - dimer level (quantitative). Coagulation profile (Prothrombin time/ Partial thromboplastin time/ International normalized ratio).
~Troponin level. Arterial blood gases when needed."
15783635|NCT04584593|Biological|Sample|Men will give semen, saliva, nasopharyngeal, urine and blood specimens
15783636|NCT04584580|Drug|low-molecular-weight heparin|low-molecular-weight heparin administered via subcutaneous injection
15783637|NCT04584567|Drug|Doxycyclin|daily (100mg)
15783638|NCT04584554|Behavioral|BETTER Transitional Care Intervention|Patient and family will receive pre- and post-discharge support and education from interventionist.
15783639|NCT04584541|Biological|blood tests|Memory T and B cell response assessment Humoral response assessment (Specific anti-Sars-Cov-2 antibodies characterization)
15783640|NCT04584541|Biological|Nasopharyngeal swabs|SarS-Cov-2 viral load assessment
15783641|NCT04584541|Biological|Stools|SarS-Cov-2 viral load assessment
15783642|NCT04584528|Other|Electronic Health Record (EHR) Embedded Individualized Pain Plan (IPP)|"The IPPs will be developed by the Sickle Cell Disease providers at each study site based on patients' outpatient chronic opioid use and analgesic agent normally required for treatment of VOE in the ED. The Sickle Cell Disease provider will review the IPP with the patient, then upload the IPP to the patient's EHR in a location that will be accessible by the patient and ED provider. Each participating site will train patients and Emergency Department (ED) providers on how to access the IPP in the Electronic Health Record. The following required elements will be included in the EHR-embedded IPP:
~Genotype
~Individual pain plan-preferred analgesic agent, route, dose and dosing interval, last update time
~Name and contact information for the SCD provider
~If the enrolled patient has a VOE visit at a nonparticipating ED, the patient will be able to access their IPP via the web or the patient portal app through their EHR. However, data will not be collected from these visits."
15783643|NCT04584515|Drug|IMP4297 40 mg|IMP4297 40 mg: IMP4297 alone, Itraconazole + IMP4297
15783644|NCT04584515|Drug|IMP4297 100 mg|IMP4297 100 mg: IMP4297 alone, Rifampin + IMP4297
15783673|NCT04584216|Other|Steam Eye Mask with acupoints stimulation|A participant needs to use SEM with acupoints stimulation once a day for 10 days and use hands to massage the acupoints on the eyebrows for the first 3 minutes, total application time at least for 20 minutes.
15783645|NCT04584502|Behavioral|Mindful Moms Yoga Mindfulness Intervention|MMORE is an 8-session yoga-mindfulness intervention protocol, offered over the course of 10 consecutive weeks at the partner maternity care practice or a nearby location. Each session will last approximately 60 minutes (8 - 10 participants per group). Intervention participants will also be asked to use a mobile companion app at least once each week of the intervention period.
15783646|NCT04584489|Other|iron stores assessment.|assessment of iron stores by measuring serum ferritin level (mandatory), serum iron and transferrin saturation.
15783647|NCT04584476|Procedure|superior capsular reconstuction|these patients underwent arthroscopic superior capsular reconstuction
15783648|NCT04584476|Procedure|partial rotator cuff repair|these patients underwent arthroscopic partial rotator cuff repair
15783649|NCT04584450|Other|Questionnaire|data collection using questionnaire
15783650|NCT04584437|Other|Infrared Energy and Dietary Supplement|Infrared Energy with a wavelength of 5 - 20 microns. Multivitamins and minerals including Vitamin C Supplements.
15783651|NCT04584424|Other|The study does not required|The study is prospective multi-center COVID-19 patient cohort
15783652|NCT04584411|Diagnostic Test|Cardiac Magnetic resonance imaging|"The following basic sequences will be conducted:
~Cine imaging using SSFP sequence for cardiac structure and function.
~Tissue characterization imaging, T1 and T2.
~Myocardial perfusion imaging.
~Late gadolinium enhancement.
~Diagnosis of myocarditis will be based on the modified Lake Louise criteria:
~T2-weighted: any of the following standard T2 sequences: regional high signal standard T2 sequences: global signal intensity ratio (myocardium/skeletal muscle) ≥2 T2 mapping: increased T2 relaxation times T1-weighted: any of the following late enhancement imaging: non-ischemic (subepicardial or mid myocardial) late enhancement native T1 mapping: increased T1 relaxation times or extracellular volume supportive criteria: signs of pericarditis: effusion or pericardial late enhancement regional or global wall motion abnormalities[5]"
15783653|NCT04584398|Device|Respiratory muscle training with steam inhalation|
15783654|NCT04584385|Diagnostic Test|EEG|EEG monitoring
15783655|NCT04584372|Dietary Supplement|High-nitrate intervention|The 2×70 mL of nitrate-rich (i.e., 'high nitrate') beetroot juice contains 12.9 mmol nitrate (NO3-).
15783656|NCT04584372|Dietary Supplement|Low-nitrate intervention|The 2×70 mL of nitrate-depleted (i.e., 'low nitrate') beetroot juice contains 0.04 mmol (or less) nitrate.
15783657|NCT04584359|Other|HVLA|High velocity, low amplitude manipulation for the sacroiliac joint and T10-L2. The interventions were performed once a week for four weeks by a physiotherapist with a degree in in osteopathy and ten years of clinical experience. Each visit lasted about 5 minutes.
15783658|NCT04584359|Other|global osteopathic protocol|Myofascial, visceral, and articular techniques. Complete treatment in order to restore and rebalance internal tensions and improve the visceral mobility: muscle inhibition techniques for the psoas muscle; deep massage in the obturator foramen; stretching for the greater omentum; lift of the uterus, ovary, and bladder ; abdominal maneuver; and thrust of sacroiliac joint and T12-L1. The interventions were performed once a week for four weeks by a physiotherapist with a degree in in osteopathy and ten years of clinical experience. Each visit lasted about 15 minutes.
15783659|NCT04584359|Other|pelvic floor muscle training|Pelvic floor muscle training for four weeks, with a weekly face-to-face visit lasting 10-20 minutes. In this intervention, participants were instructed to perform three sequences of exercises: contractions and relaxations (three seconds of sustained contractions and six seconds of rest), ten sustained contractions (ten seconds of sustained contractions and 20 seconds of rest), and five contractions associated with a cough. These exercises were performed in the standing, sitting, and lying positions
15783660|NCT04584346|Dietary Supplement|Liquigen MCT oil|MCT oil is considered is a nutritional supplement.
15783661|NCT04584333|Behavioral|Brief intervention|Group 1 (intervention group): depending on the willingness to change evaluated with the RCQ at each visit, the characteristics of the intervention to be performed will be established. Prochaska and DiClemente (1983) proposed a transtheoretical model of change in which different stages of change are identified that have been found to be predictive of adherence to treatment and its efficacy (Prochaska, Norcross and DiClemente, 1994). The RCQ includes three of the stages of change: Precontemplation, Contemplation and Action. In the Precontemplation stage, the person does not consider that he has a problem and has no intention of changing, in the Contemplation stage, he begins to contemplate that he has a problem and the possibility of change is raised and in the action stage, he has already started actively make a change in your behavior.
15783662|NCT04584320|Other|Stool sample|Stools samples taken daily to test for present of Clostridium butyricum and Clostridium neonatale
15783663|NCT04584307|Drug|Elotuzumab|Elotuzumab 10-20mg/kg
15783664|NCT04584307|Drug|Pomalidomide|Pomalidomide 2mg
15783665|NCT04584294|Behavioral|MyPath Web-Based Informational and Decision Support Tool|"The MyPath Decision Support Tool includes the following sections and features:
~Questions to capture reproductive goals and orientations towards a potential pregnancy
~Education modules about the menstrual cycle, fertility, and prepregnancy health with the opportunity to flag topics that are relevant and of interest to the patient
~A contraceptive decision module that provides education, elicits patient preferences about different aspects of contraception, and suggests methods most appropriate based on the patient's preferences
~A feature for adding free-text questions that patients may have for their provider
~An email with a summary page that the patient can bring to a visit to guide discussions with primary care providers about reproductive needs"
15783666|NCT04584268|Behavioral|mindfulness|in person and smart phone application mindfulness practice
15783667|NCT04584268|Other|standard medical education|standard medical education / control
15783668|NCT04584255|Drug|Niraparib|Predetermined dosage PO Daily
15783669|NCT04584255|Drug|Dostarlimab|Predetermined Dosage, IV,q3 weeks
15783670|NCT04584242|Drug|gluconon tab 15mg|frosting and formulation : a round, convex tablet of white to gray. path of administration : once a day, two tabs, oral Amount of raw material medication (1 pill) : Pioglitazone hydrochloride 16.53mg storage method : Store 15 to 30°C to avoid light-tight containers and moisture manufacturing source : DONG-A ST
15783671|NCT04584242|Drug|suganon tab 5mg|frosting and formulation : pink circular film coating tablets path of administration : once a day, one tabs, oral Amount of raw material medication (1 pill) : Evogliptin tartrate 6.869mg(5mg as evogliptin) storage method : Confidential containers, stored at room temperature (1-30°C) manufacturing source : DONG-A ST
15783672|NCT04584229|Other|Intervention|Intervention: comprehensive individual or collective interview, recorded and transcribed
15783674|NCT04584216|Other|Steam Eye Mask|A participant needs to use SEM once a day for 10 days, total application time at least for 20 minutes.
15783675|NCT04584203|Diagnostic Test|Bedside Echocardiography|"All the intensivists performing the TTE in the involved centers fulfill the criteria of the American Society of Echocardiography and of the European Society of Intensive Care Medicine to be considered as experts in critical care echocardiography.
~Each center performs the TTE evaluation by means of the ultrasound device available in the unit equipped with the tissue Doppler imaging program and a phased array transducer of 2.5 MHz and doppler signals is recorded along with the electrocardiogram.
~For the purpose of this study, the following TTE parameters are recorded from the apical 4-chamber view during each set of measurements:"
15783676|NCT04584203|Procedure|Spontaneuos breathing trial|The Spontaneous Breathing Trial will be performed accordingly to the clinical practice of the involved centers (a total support - including positive end-expiratory pressure plus pressure support equal or lower to 8 cmH20)
15783677|NCT04584177|Behavioral|Arm-hand BOOST program|The arm-hand boost program is provided 1 hour/day, 5x/week for 4 weeks, on top of their usual care program. The focus of the boost program is on scapula-setting, core-stability when reaching, movements with 30-60° flexion/abduction in shoulder, fine manipulation and integration in complex ADL tasks. Additionally, patients exercise 1 hour per week using the Armeo Power (Hocoma). Therefore, the additional arm-hand boost program consists of 24 one-hour sessions, provided over four weeks.
15783678|NCT04584177|Behavioral|Control program|A dose-matched program of strengthening exercises for the lower limbs and general reconditioning
15783679|NCT04584164|Device|sialendoscopy|The patients applying the hygiene rule and benifiting in addition a sialendoscopy treatment with a local injection of corticostéroïdes (at the end of the procedure) in the treatment for Xerostomia.
15783680|NCT04584151|Procedure|regional analgesia|Insertion of bilateral ESP catheters
15783681|NCT04584138|Behavioral|Study of eye movements|The assessment of eye movement during autobiographical retrieval (i.e., retrieval of personal memories) in patients with Alzheimer's Disease.
15783682|NCT04584125|Drug|Riboflavin 5'-phosphate in 20% dextran ophthalmic solution) 0.146%|A wavelength of 365 nm ultraviolet A light will be used to direct 5.4 J/cm2 using a beam diameter of 9.5mm to treat the de-epithelialized corneal surface of a donor cornea for 30 minutes. Every 5 minutes, the UV light will be used while another drop of riboflavin is applied on top of the donor cornea.
15783683|NCT04584112|Drug|Tiragolumab|Tiragolumab 840 milligrams (mg) administered by intravenous (IV) infusion on Day 1 of every 28-day cycle.
15783684|NCT04584112|Drug|Atezolizumab|Atezolizumab 1680 mg administered by IV infusion on Day 1 of every 28-day cycle.
15783685|NCT04584112|Drug|Nab-paclitaxel|Nab-paclitaxel 100 milligrams per square meter (mg/m^2) administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
15783686|NCT04584112|Drug|Tiragolumab|Tiragolumab 420 mg administered by IV infusion Q2W.
15783687|NCT04584112|Drug|Atezolizumab|Atezolizumab 840 mg administered by IV infusion Q2W.
15783688|NCT04584112|Drug|Nab-paclitaxel|Nab-paclitaxel 125 mg/m^2 administered by IV infusion QW.
15783689|NCT04584112|Drug|Carboplatin|Carboplatin (area under the concentration-time curve [AUC]: 5 milligrams per milliliter per minute [mg/mL/min]) administered by IV infusion Q3W.
15783690|NCT04584112|Drug|Doxorubicin|Doxorubicin 60 mg/m^2 Q2W administered by IV infusion.
15783691|NCT04584112|Drug|Cyclophosphamide|Cyclophosphamide 600 mg/m^2 Q2W administered by IV infusion.
15783692|NCT04584112|Drug|Granulocyte colony-stimulating factor (G-CSF)|G-CSF support for four doses.
15783693|NCT04584112|Drug|Granulocyte-macrophage colony-stimulating factor (GM-CSF)|GM-CSF support for four doses.
15783694|NCT04584086|Device|MRI 3 tesla|"1.5 Tesla MRIs, usually used as pre-treatment and, between 3 and 6 months after irradiation, are replaced in the study by 3 Tesla MRIs (pre-treatment and at 6 months)
~In addition, two additional MRIs, also performed with a 3 Tesla magnetic field, will be performed:
~During treatment when half of the prescribed dose has been delivered.
~1 month after the end of the irradiation."
15783695|NCT04584073|Procedure|Adenoidectomy alone or with Myringotomy or with Myringotomy and Tympanostomy Tube application|Adenoidectomy with or without tonsillectomy when indicated will be performed. simple Myringotomy incision will be done in the antero-inferior quadrant of pars tensa of both tympanic membranes. Middle ear fluids will be aspirated. Tympanostomy tube application will be done.
15783696|NCT04584060|Combination Product|ERAS protocols|ERAS protocols including avoidance of prolonged pre-operative fasting and early removal of Ryle, surgical drains and urinary catheter
15783697|NCT04584060|Combination Product|Early oral feeding|Chewing gum, oral magnesium and alvimopan can be started early postoperatively, Initiation of feeding-Oral sips on day 1, step up day 2 onward
15783698|NCT04584060|Combination Product|Prophylaxis against DVT|Patient will wear well-fitting compression stockings and receive pharmacological prophylaxis with LMWH. Encourage to mobilize out of bed after effect of general anesthesia has weaned off.
15783699|NCT04584047|Procedure|Cell-based non-invasive prenatal testing|Blood sampling.
15783700|NCT04584034|Drug|Salbutamol|Salbutamol will be delivered using a Babyhaler spacer device. Ventolin will be used, brandname for Salbutamol sulfate. Ventolin contains the propellant HFA 134a.
15783701|NCT04584034|Drug|Placebo|The placebo will be delivered using a Babyhaler spacer device. The placebo will contain only the propellant HFA 134a.
15783702|NCT04584021|Device|Xiaomi MiBand3|Recording of sleep, activity and heart rate data to study their association with stress.
15783703|NCT04584021|Other|Socio-demographic questionnaire|Self-made questionnaire to be filled by the participants at the beginning of the study with the following personal data: age, gender, marital status, residential environment, cohabitation unit, educational level, socio-economic level, contract, working hours, overtime or not, number of overtime hours in a day, overtime frequency and perceived stress level
15783704|NCT04584021|Other|EuroQol-5D-5L|Quality of life questionnaire to be filled by the participants at the beginning, mid-term and completion of the study with the following information: severity index, social value index for each health condition. Subjective evaluation of health status from 0 to 100.
15783705|NCT04584021|Other|Pittsburgh Sleep Quality Index (PSQI)|Questionnaire to be filled by the participants whose outcome is the perceived quality, quantity and efficient of sleep. To be given at the beginning, mid-term, and completion of the study.
15783924|NCT04582019|Device|stent extraction|stent extraction using magnetic retriever or flexible cystoscope
15783706|NCT04584021|Other|State-Trait Anxiety Inventory (STAI)|Questionnaire to be filled by the participants which measures the anxiety level. To be given at the beginning, mid-term and completion of the study.
15783707|NCT04584021|Other|Perceived Stress Scale-10 (PSS-10)|Questionnaire to be filled by the participants which measures the stress level. To be given at the beginning, mid-term and completion of the study.
15783708|NCT04584021|Other|Stress questionnaire|Questionnaire designed by a work stress psychologist professional from the research group which is focused on stress and daily functioning. This questionnaire was given for the participants to fill. It is composed by 3 daily items and 4 weekly items.
15783709|NCT04584008|Drug|FGFR Inhibitor, IDH1 Inhibitor, HER2 Inhibitor, PARP Inhibitor, BRAF Inhibitor, MEK Inhibitor, ICIs, EGFR-TKIs, NTRK-TKI, and et. al.|According to the treatment dose approved by NMPA/FDA, evaluation will be conducted every 2 cycles until tumor progression or adverse events cannot be tolerated.
15783710|NCT04584008|Drug|Other Therapy|Patients will receive other treatments, including cytotoxic drugs, antiangiogenic drugs, best supportive care, clinical trials of unmatched new drugs, etc..
15783711|NCT04583995|Biological|SARS-CoV-2 rS/Matrix M1-Adjuvant|Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS co-formulated with Matrix-M1 adjuvant (0.5 mL) on Days 0 and 21.
15783712|NCT04583995|Other|Placebo|Alternating intramuscular (deltoid) injections of placebo (0.5 mL) on Days 0 and 21.
15783713|NCT04583995|Biological|Licensed seasonal influenza vaccine|Single intramuscular injection of licensed seasonal flu vaccine, administered ideally in opposite deltoid to SARS-CoV-2 rS with Matrix-M1 adjuvant or placebo injection on Day 0.
15783714|NCT04583982|Other|T-Detect™ SARS-CoV-2 Assay|T-Detect™ SARS-CoV-2 Assay is an investigational device that is indicated to assess T-cell immune response to SARS-CoV-2 via the testing of blood samples from patients with signs and symptoms of suspected COVID-19. These results will not be shared with the participant.
15783726|NCT04583865|Other|teleconsultation|In the pandemic period linked to COVID, pediatric pre-anesthesis consultations should preferably be carried out by teleconsultation. This is to assess the effectiveness of these teleconsultation and the satisfaction of parents.
15783727|NCT04583852|Other|AIVÍA, Ultra-Brightening Spot Micro-needle Patch|a dissolving micro-needle patch, contains active ingredients
15783728|NCT04583852|Other|Placebo Micro-needle Patch|matching placebo will be provided as a dissolving micro-needle patch
15783729|NCT04583839|Behavioral|Patient Navigation Program|SWEET is a GDM-focused intervention that will apply barrier-reduction patient navigation strategies to improve health after a pregnancy with GDM. Women in SWEET will receive GDM-specific, tapered, individualized navigation services, including logistical support, psychosocial support, and patient education, through 1-year postpartum.
15783730|NCT04583826|Device|CAVA|CAVA is a medical device containing 5 face-mounted ECG electrodes which are used to record the movement of the eyes.
15783731|NCT04583813|Drug|Empagliflozin|Empagliflozin 10 mg oral tablet, once daily, for 24 months
15783732|NCT04583813|Other|Placebo|Empagliflozin matching placebo, once daily, for 24 months
15783735|NCT04583774|Other|Prediction error tasks|The intervention involves two tasks, one that involves taste stimuli and another that involves monetary stimuli, and test their impact o brain response in electro encephalography (EEG) and functional magnetic resonance imaging (fMRI)
15783736|NCT04583761|Behavioral|questionnaire|Mailed structured regarding current and former tobacco consumption and use of alternative nicotine delivery systems
15783737|NCT04583748|Behavioral|Sahaj Samadhi Meditation|Sahaj Samadhi Meditation (SSM) is a form of automatic self-transcending meditation that involves relaxed attention to a precise sound (mantra), to allow stress reduction and deep relaxation. This technique is easy to learn and offers the support of a group and facilitator.
15783738|NCT04583748|Behavioral|Health Enhancement Program|The Health Enhancement Program (HEP) is a standardized program used to teach participants about health promotion, including the benefits of a lifestyle of healthy diet, music, recreation, and exercise. In HEP, participants get the support of a group and facilitator, and talk through and try to implement positive health-enhancing life changes.
15783741|NCT04583722|Dietary Supplement|AX-olive oil-PP emulsion|single dose and plasma samples
15783742|NCT04583709|Device|ECG Belt|"ECG Belt Research System Procedure LBBP Native conduction RV pacing if available Bipolar LBBP Unipolar LBBP - nonselective and selective (different outputs) Fusion pacing with native conduction at different Atrioventricular (AV) delays
~HOT-CRT Native conduction HBP / LBBP HOT-CRT AV delay optimization. Medtronic Device (pacemaker/ICD) based Holter recording during the ECG belt recording"
15783743|NCT04583696|Dietary Supplement|The Investigation of effect on Blood Lipid parameters with walnut addition of Diet|Participants were asked to consume 30 g of walnuts daily for 21 days. Individuals have consumed walnuts on an empty stomach in the morning or with breakfast.
15783744|NCT04583683|Behavioral|Very low calorie diet with Fortimel (Nutricia) supplementation|Patients will undergo a very low calorie diet
15783745|NCT04583683|Procedure|Metabolic Surgery|Patients will undergo metabolic surgery
15783746|NCT04583657|Other|Eggs|Consumption of two eggs (control or test) per day during three months
15783747|NCT04583644|Device|Fetoscopic Endoluminal Tracheal Occlusion Surgery|"Fetoscopic Endoluminal Tracheal Occlusion (FETO) surgery will be completed at 27 weeks 0 days - 29 weeks 6 days gestation.
~Fetoscopic removal of the balloon occlusion will be performed at 34 weeks 0 days to 34 weeks 6 days gestation."
15783748|NCT04583631|Procedure|Adenoidectomy surgery|All patients underwent adenoidectomy under general anesthesia by routine curettage method and adenoid tissues were put in formaldehyde and sent to the genetics department for the exploration of ER stress and apoptosis markers.
15783754|NCT04583605|Device|PREVENA|A negative pressure wound closure therapy is used after lymph node dissection
15783755|NCT04583592|Drug|Camostat Mesilate|Camostat mesilate administered as oral 100 mg round tablets. Study dose: Two 100 mg tablets (200 mg total) taken orally 4 times daily for 14 days.
15783756|NCT04583592|Drug|Placebo|Placebo administered as oral round tablets. Study dose: Two placebo tablets taken orally 4 times daily for 14 days.
15783762|NCT04583566|Genetic|COVID-19 Diagnostic and Assessment Tests|Complete Blood Count (CBC), Differential leukocytes, D-dimer, C-Reactive Protein, Polymerase Chain Reaction (PCR) Test, Ferritin level, Cytokines Profile, Transcriptome Analysis, miRNA Analysis.
15783763|NCT04583553|Diagnostic Test|Vikor Scientific Urine-IDTM|Urine samples will be collected for both standard laboratory culture at KUMC Lab and expedited delivery to Vikor Scientific Lab for Urine-IDTM analysis. Vikor Scientific will cover all costs associated with sample delivery. If insufficient urine volume is collected for both standard laboratory culture at KUMC Lab and Vikor Scientific Urine-IDTM, urine will be preferentially used for standard laboratory culture at KUMC Lab.
15783764|NCT04583527|Device|ALV1 System|The ALV1 system is designed to create a controlled size interatrial shunt via a proprietary intra-cardiac catheter. There is no temporary or permanent implant used to create or maintain the interatrial shunt. The therapy is intended to be delivered in a single procedure administered under general anesthesia in a cardiac catheterization laboratory.
15783765|NCT04583514|Behavioral|Control|Weight-stable Control group
15783766|NCT04583514|Behavioral|Overfeeding|30% Overfeeding group
15783767|NCT04583501|Biological|Omalizumab|Omalizumab will used as dose comparable to to 0.016 mg/kg/IU in serum.
15783768|NCT04583488|Drug|Intraperitoneal docetaxel|Up to 3 dose levels of intraperitoneal docetaxel will be studied (45mg/m2, 65 mg/m2, 85 mg/m2).
15783769|NCT04583462|Drug|Metformin|Metformin, started at 500 mg per day per os and titrated up to 2000 mg during 2 years (increase of 500 mg every two weeks)
15783770|NCT04583462|Drug|Placebo|Control group : Placebo (coated tablet similar to metformin tablet titrated following the same schedule as in the experimental arm) started at 500 mg per day per os and titrated up to 2000 mg during 2 years (increase of 500 mg every two weeks)
15783771|NCT04583449|Behavioral|Mental imagery|"Mental imagery involves the mental representation of a future event, action, or task. By imitating or rehearsing this mental event or series of events (Taylor et al., 1998, p. 430) mental imagery interventionists theorise that an individual's preparation for, and motivation toward, a future action can be made more likely. Mental imagery involves an individual following a set of pre-defined exercises involving thinking about, visualising and writing about a health-related action. Mental imagery exercises can involve focusing on anticipated positive/beneficial outcomes of an action (outcome imagery) or imagery relating to the anticipated strategies/preparation that would be required to successfully execute a pre-defined action (process imagery)."
15783772|NCT04583436|Device|Endovascular recanalization|Recanalization with angioplasty and stenting: Under local anesthesia, a standard endovascular approach is performed and the affected arterial segment is visualized. Perform transluminal or subintimal recanalization of the occluded segment of the arteries with a hydrophilic guide wire. Next, balloon angoplasty of the recanalized segment is performed. After control angiography, a biomimetic braided nitinol stent is placed throughout the lesion.
15783773|NCT04583436|Other|Open surgery|Femoropopliteal distal bypass with a synthetic ePTFE graft: Under general anesthesia, 2 standard open surgical approaches are performed: one to the common femoral artery, superficial femoral artery and deep femoral artery; the second - to the third portion of the popliteal artery, the tibioperoneal trunk and the anterior tibial artery. After systemic heparinization, clamps are applied to the arteries. A longitudinal arteriotomy of the popliteal artery is performed, and a distal end-to-side anastomosis is formed between the artery and the graft. Next, the graft is passed into the groin wound. Longitudinal arteriotomy of the common femoral artery. A proximal end-to-side anastomosis is formed between the shunt and the common femoral artery. Clamps are removed from arteries, blood flow is started, surgical hemostasis, wound drainage, layer-by-layer wound closure is performed.
15783776|NCT04583410|Drug|Nicotine patch|"NICOPATCHLIB, 7mg/24h Day 1 to day 3 : 3,5 mg/day Day 4 to day 9 : 7 mg/day Day 10 to Day 15 : 10,5 mg/day Day 16 to day 98 : 14 mg/day
~Decrease treatment Day 99 to day 105 : 10,5 mg/day Day 106 to day 112 : 7 mg/day Day 113 to Day 119 : 3,5 mg/day"
15783777|NCT04583410|Drug|Placebo patch|"PLACEBO OF NICOPATCHLIB, 7mg/24h Day 1 to day 3 : 3,5 mg/day Day 4 to day 9 : 7 mg/day Day 10 to Day 15 : 10,5 mg/day Day 16 to day 98 : 14 mg/day
~Decrease treatment Day 99 to day 105 : 10,5 mg/day Day 106 to day 112 : 7 mg/day Day 113 to Day 119 : 3,5 mg/day"
15783778|NCT04583397|Other|radio frequency electromagnetic fields|Exposure system delivers emissions comparable to those from a WiFi access Point close to the bed or sham (no exposure)
15783779|NCT04583384|Diagnostic Test|1H-Spectroscopy MRI|"PRESS asymetric monovoxel  PROBE , TE 144 ms, TR 2500 ms, 768 or 1024 averages"
15783780|NCT04583371|Other|MECHANICAL PULMONARY HYPERINFLUATION|For basal aspiration, the patient will be placed in the supine position with the head elevated at 30º, will be submitted to a single aspiration with a size 12 probe (Mark Med), with a vacuum adjusted to -40cmH2O of pressure, with basic asepsis care being maintained for performing the technique. In the participants of the intervention group, the calculation of the ideal tidal volume of each patient will be performed, after which they will be positioned in the same way as baseline aspiration, in assisted-controlled pressure ventilation, increasing 10 cmH2O in inspiratory pressure and, in ventilatory mode. -controlled by volume, we will increase 50% of the tidal volume for a period of 10 minutes, observing the peak that cannot exceed 40 cmH2O in both ventilation modes, and then three aspirations will be performed for 15 seconds and with an interval of 30 seconds.
15783783|NCT04583345|Behavioral|Questionnaires|Questionnaires: Physical therapists ask questions these assess quality of life, anxiety and depression, physical activity level.
15783784|NCT04583332|Other|Rhymes|"Participants will be provided with a choice of 3 Nursery rhymes (Wheels on the bus, Old McDonald and Twinkle Twinkle Little Star) Objects pertaining to the 3 rhymes will be placed on a board Children will be given prompts as per their need and will be marked on the type of prompt given.
~These children will transit to pictures and Makaton symbols, if they are able to make choices using objects."
15783785|NCT04583332|Other|Individual Items in Rhymes|"Participants will be provided with a choice of 3 pictures within the initial choice making of the 2 Nursery rhymes (Wheels on the bus and Old McDonald ) Wheels on the Bus will include - mama/wipers/horn McDonalds - cow/dog/cat Objects pertaining to the 3 rhymes will be placed on a board Children will be given prompts as per their need and will be marked on the type of prompt given.
~These children will transit to pictures and Makaton symbols, if they are able to make choices using objects."
15783786|NCT04583332|Other|Objects|Participants will be provided with 2,3 and 4 sensory objects. Participants will opt for an object by making a choice between these objects, if this is achieved then the child will be moved to picture level and symbol.
15783787|NCT04583319|Diagnostic Test|EasyCov POC|Saliva samples will be collected according to the sampling protocol defined each for EASYCOV test. The EasyCoV test will be performed at the beginning of the study before obtaining the routine RT- PCR test results. The operators performing this test will be blinded from the routine RT-PCR results.
15783788|NCT04583306|Other|Raman analysis of saliva, characterization of the Raman database and building of the classification model|Saliva will be collected, processed and analysed through Raman spectroscopy. Data acquired will be normalized and treated for the creation of the classification model.
15783789|NCT04583293|Other|No intervention|This study does not involve any intervention or new treatment.
15783793|NCT04583267|Drug|tenofovir disoproxil fumarate (TDF) 300mg co-formulated with emtricitabine (FTC 200mg) once daily oral administration|Participants will take tenofovir disoproxil fumarate (TDF) 300mg co-formulated with emtricitabine (FTC 200mg) once daily oral administration for preventing HIV infection.
15783794|NCT04583254|Radiation|External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Experimental|40 Gy / 15 Fractions EBRT + HDR-Brachytherapy
15783795|NCT04583254|Radiation|External beam radiotherapy (EBRT) + High-dose rate (HDR) Brachytherapy Standard of Care|45 Gy / 25 Fractions EBRT + HDR-Brachytherapy
15783796|NCT04583254|Drug|Concurrent Chemotherapy|Weekly cisplatin 40 mg/m2 for a maximum of 5 cycles
15783797|NCT04583241|Other|Constitution of serum bank and urine bank at D0|Blood samples and urine at Day 0 (day of surgery)
15783798|NCT04583241|Other|Constitution of serum bank and urine bank during follow-up|Blood samples and urine are obtained at week 2, week 6 post-surgery, at the end of antibiotherapy and 6 months post-surgery, only for patients with staphylococcus aureus monoinfection who are follow-up during two years.
15783799|NCT04583241|Other|ELISA assays of serum and urinary markers of bone remodeling at D0|Assessment by ELISA assays of serum and urinary markers of bone remodelling: the osteocalcin (OC), the procollagen propeptide type 1 (PINP), the cross linked telopeptide of type 1 collagen (CTX1) and the periostin at Day 0 (day of surgery)
15783800|NCT04583241|Other|ELISA assays of serum and urinary markers of bone remodeling during follow-up|Assessment by ELISA assays of serum and urinary markers of bone remodelling: the osteocalcin (OC), the procollagen propeptide type 1 (PINP), the cross linked telopeptide of type 1 collagen (CTX1) and the periostin at week 2, week 6 post-surgery, at the end of antibiotherapy and 6 months post-surgery, only for patients with staphylococcus aureus monoinfection who are follow-up during two years
15783801|NCT04583241|Other|Analysis of bacterial gene expression at D0|Assessement of bacterial gene expression on surgery residual tissue (bone tissue, joint fluid, fragment of prostheses) collected at Day 0 (day of the surgery)
15783802|NCT04583228|Drug|HLX71|Single-dose, intravenous infusion
15783803|NCT04583228|Other|Placebo|Single-dose, intravenous infusion
15783804|NCT04583215|Device|Paired Associative Stimulation (PAS)|On each of the 10 days of the intervention, participants will receive PAS (or PAS-C) to the left DLPFC by delivering peripheral nerve stimulation (PNS) to the right median nerve and TMS to the left DLPFC, followed immediately by PAS (or PAS-C) to the right DLPFC by delivering PNS to the left median nerve and TMS to the right DLPFC. PAS-C differs from PAS only by including an interstimulus interval of 100 ms between PNS and TMS to the DLPFC, compared to 25 ms in the active PAS condition. Using 100 ms interval, we have previously demonstrated that PAS-C does not induce PAS-LTP in the DLPFC. If a participant cannot attend one or more of the 10 consecutive PAS or PAS-C treatment sessions, we will allow up to four extra treatment days to make up for missed sessions.
15783805|NCT04583202|Other|Exposure to placebo|Patients are exposed to a placebo for 4h in the Alyatec EEC
15783806|NCT04583202|Other|Exposure to allergen|Patients are exposed to birch pollen allergens for 4h in the Alyatec EEC
15783807|NCT04583189|Diagnostic Test|Performance of the test antigenic and test RT-PCR|Each patient will have 1 test rapid antigenic Biosynex Covid-19 Ag-BSS with the results in 15-20 minutes and 1 reference test RT-PCR analyzed in microbiology laboratory of the hospital.
15783808|NCT04583163|Diagnostic Test|Transcranial Doppler|Transcranial Doppler is a non-invasive, painless, ultrasound technique that uses high frequency sound waves to measure the rate and direction of blood flow vessels in the brain.
15783809|NCT04583150|Procedure|Bariatric surgery|Bariatric surgery : sleeve gastrectomy or Roux-en-Y gastric bypass (RYGB)
15783810|NCT04583137|Drug|Lidocain|Layngeal direct fiberoptic examination transnasaly
15783811|NCT04583124|Other|ATENTO-B|Patients will perform therapeutic exercise and vagal activation techniques before medical treatment and will follow the usual care after medical treatment.
15783812|NCT04583124|Other|ATENTO-T|Patients will perform therapeutic exercise and vagal activation techniques throughout medical treatment and will follow the usual care after medical treatment.
15783813|NCT04583111|Drug|Domperidone|Domperidone and sulpiride are antiemetics that may be useful in preventing the PEG-related nausea and vomiting.
15783814|NCT04583111|Drug|sulpiride|Domperidone and sulpiride are antiemetics that may be useful in preventing the PEG-related nausea and vomiting.
15783815|NCT04583098|Other|fecal microbiota transplantation|frozen stool from donors who had already finished recommended blood & stool screening for stool donors
15783817|NCT04583059|Other|Taping|A hard-preventive Zinc oxide tape was used in this study. Taping procedure consists of three separate steps: First step involved application of the anchor tape, which achieved by applying the tape circumferentially just above the malleolar level at the lo
15783818|NCT04583046|Drug|normal saline inhalation|When anesthesia induction finishes, change patients' position from supine to lateral position and measure ABGA, VBGA while two lung is ventilated (T0). After 20 minutes of applying one-lung ventilation, measure ABGA and VBGA (T1). Apply normal saline inhalation for control group and measure ABGA at the time of 20 min after normal saline inhalation has finished (T2).
15783819|NCT04583046|Drug|iloprost inhalation|When anesthesia induction finishes, change patients' position from supine to lateral position and measure ABGA, VBGA while two lung is ventilated (T0). After 20 minutes of applying one-lung ventilation, measure ABGA and VBGA (T1). Apply iloprost inhalation for iloprost group and measure ABGA at the time of 20 min after iloprost inhalation has finished (T2).
15783820|NCT04583033|Behavioral|Cognitive Behavioral Therapy (CBT)|Treatment components include stimulus control, sleep restriction therapy, relaxation, and cognitive therapy. Each session will last approximately one hour and will be provided on line.
15783821|NCT04583020|Drug|Camrelizumab|Neoadjuvant Camrelizumab 200mg IV, adjuvant Camrelizumab 200mg IV (once every two weeks, until progress)
15783822|NCT04583020|Radiation|radiation|60Gy/30
15783823|NCT04583020|Drug|Temozolomide|Given PO during RT 75mg/m2/d; 4 weeks post RT 150-200mg/m2/d days 1-5, 4 weeks/cycle, 6 cycles
15783888|NCT04582396|Procedure|Normal saline injection|An injection of normal saline will be injected into muscle on either side of the voice box in the neck. It will be administered in an inpatient monitored setting.
15783825|NCT04582994|Behavioral|Beta tACS|participants perform the Mental Time Travel task (duration 20 minutes), while tACS stimulation is delivered at Beta frequencies (22 Hz)
15783826|NCT04582994|Behavioral|Alfa tACS|participants perform the Mental Time Travel task (duration 20 minutes), while tACS stimulation is delivered at Alfa frequencies (10 Hz)
15783827|NCT04582994|Behavioral|Sham|participants perform the Mental Time Travel task (duration 20 minutes), while Sham tACS stimulation is delivered
15783830|NCT04582968|Other|Pyrotinib Plus Capecitabine combined with brain radiotherapy|Drug combined with radiation
15783831|NCT04582955|Drug|Chidamide in combination with chemotherapy|Chidamide, orally,20mg at day 0,4,7,11,21,every 3 weeks; in combination with Docetaxel 75mg/m2,intravenous infusion，at day1 every 3 weeks，and Epirubicin 75mg/m2, intravenous infusion，at day1 every 3 weeks
15783832|NCT04582942|Drug|PEG|Patients began to drink 1 L of PEG at 8:00 PM on the day before colonoscopy at a rate of 250 mL every 10- 15 minutes. On the day of the procedure, patients took the remaining 2 L of PEG 4-6 hours before colonoscopy.
15783833|NCT04582942|Drug|PEG+lactulose|On the day before colonoscopy , Patients took 45 mL lactulose solution at 7:00 PM. And then Patients began to drink 1 L of PEG at 8:00 PM at a rate of 250 mL every 10- 15 minutes. On the day of the procedure, patients took 45 mL lactulose solution and the remaining 2 L of PEG 4-6 hours before colonoscopy.
15783834|NCT04582929|Drug|Neuronox ® Injection|Neuronox ® 50 or 100 unit intramuscular injection
15783835|NCT04582916|Drug|11C-MCI|Injected IV followed by PET scanning
15783836|NCT04582916|Drug|11CPS13|Injected IV followed by PET scanning
15783837|NCT04582877|Device|FFR measurement|FFR is measured sequentially with the test article and the predicate device.
15783840|NCT04582851|Other|some risk factors correlated with TMD|exposure factors causing TMD
15783841|NCT04582838|Diagnostic Test|Pulse oximeter|"In both groups, pulse oximeters provide continuous monitoring of oxygen saturation (SpO2).
~Also, SpO2 curve can be recorded for off-line analysis."
15783842|NCT04582838|Diagnostic Test|ECG|ECG signal is used to monitor respiratory rate (RR).
15783843|NCT04582825|Other|N/A - Observational Study|N/A - Observational Study
15783844|NCT04582812|Other|Bilateral and simultaneous diaphragm ultrasonography reeducation plus inspiratory training|Bilateral and simultaneous diaphragm biofeedback reeducation plus inspiratory training during 6 weeks
15783845|NCT04582812|Other|Isolated inspiratory training|Isolated high-intensity inspiratory muscle training during 8 weeks
15783846|NCT04582799|Device|ECCO2R|Extracorporeal CO2 Removal
15783847|NCT04582799|Device|NIV|Non-invasive ventilation
15783848|NCT04582786|Drug|Morphine|Repeated bolus according to pain score
15783849|NCT04582786|Drug|Morphine HCl|Infusion of morphine HCl solution for intravenous administration
15783850|NCT04582786|Drug|STR-324|Infusion of solution for intravenous administration
15783851|NCT04582760|Other|early mobilization|In patients who require mechanical ventilation for acute respiratory failure or sepsis (non-malignant tumor patients), early mobilization will be performed in addition to conventional bedside physical therapy, for 30 mins per session, two sessions per day, 7 days per week until the patients are discharged from the ICU.
15783852|NCT04582747|Diagnostic Test|Urinary Biomarkers (NGAL, DKK-3, IGFBP-7/TIMP-2, KIM-1)|"Validation of Urinary biomarker tests for the rapid prediction of AKI.
~No intervention is being proposed as part of the study. Concentrations of Urinary biomarkers will be obtained post operatively. These concentrations will be assessed to ascertain their predictive ability for the development of Acute Kidney Injury post-operatively."
15783853|NCT04582734|Behavioral|Cognitive-behavioural therapy|Cognitive-behavioural therapy intervention
15783854|NCT04582721|Other|Implantable Neurostimulator System (Spectra WaveWriter™ Spinal Cord Stimulator System), (Boston Scientific Neuromodulation Corporation, Valencia, California (CA), USA)|"the participants with chronic intractable back or back and leg pain will be implanted with the stimulation lead(s). The leads are initially connected to an external trial neurostimulator. Patients will be implanted with two epidural leads and two subcutaneous leads. A three weeks trial phase will follow. The first two days after the leads implant will be without stimulation and thereafter alternating stimulation every week will start, randomly ordering the treatments using a Williams design balanced for first-order carryover effects (i.e. incorporating 6 different treatment orders), from:
~1) CON-SCS with Subcutaneous stimulation
~2) HF-SCS
~3) Combination Therapy A patient's favored SCS mode, providing that there is at least 50% reduction in pain intensity on the NRS in the trial phase, will then be implanted and patients will be followed up for 12 months."
15783855|NCT04582708|Device|NERv's Inline Device|NERv's Inline Device is comprised of multiple sensors. It attaches in line to existing catheters or peritoneal drains that are currently approved for medical use. This allows the device to measure the pH and electrical conductivity of effluent fluids that are drained through peritoneal drains.
15783920|NCT04582058|Behavioral|Mobile Health of lifestyle|Mobile health of lifestyle with an orientation about daily activities and necessary care to patients with CEID, and protocol of exercise training with images and guidelines to execute five days per week, with a duration of 50 minutes, and space for doubts which patients could send message to researcher.
15783921|NCT04582045|Device|silver impregnated dressing|comparison of Mepilex versus our standard techniques
15783856|NCT04582695|Behavioral|Written Exposure Therapy Integrated with Cognitive Behavioral Therapy for Alcohol Use Disorder|Participants will receive 5 to 6 weeks of an integrated behavioral therapy that address posttraumatic stress disorder and alcohol use disorder. Sessions will be 60 minutes in length. It will include written exposure therapy, which involves writing about their experience of sexual assault for 30 minutes. In addition, they will receive 20 minutes of intervention focused on cognitive behavioral therapy for alcohol use disorder which involves learning skills to cope with alcohol cravings and behavior (e.g., challenging thoughts, problem solving).
15783857|NCT04582695|Behavioral|Written Exposure Therapy|Participants will receive 5 to 6 weeks of written exposure therapy, which involves writing about their experience of sexual assault for 30 minutes.
15783858|NCT04582669|Drug|Intralesional Triamcinolone 10 mg/mL|Injection of 1 mL intralesional triamcinolone 10 mg/mL in up to 3 anatomic areas.
15783859|NCT04582669|Drug|Intralesional Triamcinolone 20 mg/mL|Injection of 1 mL intralesional triamcinolone 20 mg/mL in up to 3 anatomic areas.
15783860|NCT04582669|Drug|Intralesional Triamcinolone 40 mg/mL|Injection of 1 mL intralesional triamcinolone 40 mg/mL in up to 3 anatomic areas.
15783861|NCT04582669|Drug|Placebo|Injection of 1 mL sodium chloride 0.9% in up to 3 anatomic areas.
15783862|NCT04582656|Device|Targeted microwave ablation|Targeted ablation of the index tumor with microwaves, by using either a transperineal or a transrectal approach
15783863|NCT04582643|Behavioral|6P intervention|6P assessment targeting on diet, activity and mentality, along with education provided based on the 6P components. The 6P tool serves the functions to help the women to self-monitor and be aware of their negative lifestyle choices.
15783864|NCT04582630|Dietary Supplement|omega 3 fatty acid|Participants will take 0.1-0.2 g/kg/day of omega 3 fatty acids for 7 days.
15783869|NCT04582604|Drug|modified By/Cy conditioning regimen intensified by Ruxolitinib and Decitabine|Day -15 to -14 ： Decitabine 20 mg/m2/day, Ruxolitinib 70mg bid; Day-10： Cytarabine 1.6 g/m2/day CI (only for Haploidentical and unrelated donor), Ruxolitinib 60mg bid; Day- 9： Cytarabine 4g/m2/day CI, Ruxolitinib 60mg bid; Day- 8 to -7： Busulfan 0.8mg/kg Q6h iv, Ruxolitinib 50mg bid; Day-6: Busulfan 0.8mg/kg Q6h iv, Ruxolitinib 40mg bid; Day-5： Cyclophosphamide 1.8 g/m2/day CI, Ruxolitinib 30mg bid; Day-4： Cyclophosphamide 1.8 g/m2/day CI, Ruxolitinib 20mg bid; Day-3： Carmustine 250mg/m2/day iv, Ruxolitinib 10mg bid; Day-2： Ruxolitinib 5mg bid; Day-1： Ruxolitinib 5mg qd;
15783870|NCT04582591|Drug|Cannabidiol 100 MG/ML|Patients receive cannabidiol before and after treatment with chemotherapy
15783871|NCT04582578|Device|CRT|The experimental group will be treated with CRT in addition to optimal medical therapy for HF. In addition, the trial will further compare two methods of delivering CRT. One experimental group will receive BiV-CRT, while the second experimental group will receive CS-CRT
15783872|NCT04582565|Combination Product|Decongestive lymphatic therapy (DLT)|Manual lymphatic drainage
15783873|NCT04582565|Other|Standard Care|
15783874|NCT04582552|Drug|PARP inhibitors|Ovarian cancer patients with PARP inhibitors according to the NCCN guideline and their instructions.
15783875|NCT04582539|Drug|INCB000928|INCB000928 will be administered once daily.
15783876|NCT04582526|Behavioral|BMS program|A BMS program with three components: relaxation exercises, healthy eating, expressive arts therapy
15783877|NCT04582513|Other|AnCHor-Checklist implementation|a standardized checklist using the SBAR concept according to the recommendations of the DGAI
15783878|NCT04582500|Drug|Iohexol|Iohexol (Omnipaque; GE Healthcare, Milwaukee, WI) is a low-osmolar non-ionic iodinated contrast agent that is approved by the FDA for oral use. It is routinely used orally for CT scans of the abdomen and pelvis, and has been used experimentally in CTC. Iohexol is better tolerated by patients and has a better safety profile than hyperosmolar iodinated and barium based contrast agents.
15783879|NCT04582487|Other|bone marrow and/or peripheral blood samples withdrawal|bone marrow and/or peripheral blood samples evaluation
15783880|NCT04582474|Other|Dengue module and rapid diagnostic tests|Digital platform providing clinical decision support for Dengue, Dengue rapid diagnostic tests and training will be deployed at study sites for Dengue screening, diagnosis, case management as well as reporting to surveillance system following local guidelines
15783881|NCT04582461|Device|multislice computed tomography|All patients will undergo a preoperative multiphasic multidetector CT scan before surgery.The unenhanced scan will be used to generate a CT reconstruction of the upper abdomen (from the diaphragm to the kidneys) with a 5mm thickness. Two different radiologists (D.F. and D.I.), blinded to patient information, measured total fat volume (TFV), visceral fat volume (VFV), and analyzed pixels with densities in the - 190 hounsfield units (HU) to - 20 HU range. the ratio between the density of the pancreas over the density of the spleen will be calculated and the maximum diameter of the pancreatic duct will be measured using the arterial phase in order to better identify the entire length of the duct.
15783882|NCT04582448|Drug|Insulin icodec|A single dose of insulin icodec administered subcutaneously (s.c. - under the skin) Injection in the belly, upper arm and thigh on different occasions.
15783883|NCT04582435|Drug|Insulin Icodec|Participants will receive 1 dose from a prefilled pen, administered subcutaneously (under the skin), once a week by designated study staff, for a total of at least 8 and a maximum of 16 doses which equals 8-16 weeks of treatment.
15783884|NCT04582422|Other|"Touch Therapy"|During the waiting process, first follow the touch flow chart and perform the touch in the waiting area for 10 minutes. When visiting the treatment chair, the companion will be asked to touch the child's unilateral hand for 5 minutes during the consultation process. A small chair is provided to accompany the child for a total of 15 minutes. The two groups will use the chip tool again after the consultation
15783887|NCT04582396|Procedure|stellate ganglion block injection|A stellate ganglion block (SGB) is an injection of local anesthetic (numbing medicine) to block the nerves located on either side of the voice box in the neck. It will be administered in an inpatient monitored setting.
15783889|NCT04582396|Behavioral|Psychoeducation|"The session will be 30 minutes in duration, to be administered by a health professional with experience working with CA patients, the goal will be to establish rapport and help patient identify anxious situations, thoughts, and bodily feelings related their recent CA that could lead to avoidant behavior.
~Explain how many of these feelings are common in CA survivors, and they are often unrelated to their risk of its recurrence. Explain how the body has a fight-or-flight system that is controlled in part by the stellate ganglion and explain how blocking the action of this part of the body can reduce the feelings of anxiety that commonly occur. Discuss how certain activities such as exercise can increase feelings of anxiety around bodily sensations, but continued engagement could reduce that fear and that exercise is helpful for recovering from CA"
15783890|NCT04582383|Drug|Spironolactone|Dispensation of spironolactone according to the arm description.
15783891|NCT04582383|Drug|Doxycycline Hyclate|Dispensation of doxycycline hyclate according to the arm description.
15783892|NCT04582370|Behavioral|theater program|10-week theory-based theater program designed to improve their physical functioning and reduce emotional stress.
15783893|NCT04582357|Behavioral|Physical activity program|The physical activity program is a suite of several exercises which intend to improve muscular mass of targeted muscles.
15783894|NCT04582344|Biological|CoronaVac|Two doses at 14-day interval, each inoculation dose is 0.5 mL. Two doses of dosage (each prefilled syringe of the vaccine contains 600 SU of SARS-CoV-2 virus antigen) experimental vaccine at the schedule of day 0,14
15783895|NCT04582344|Biological|Placebo|Aluminium hydroxide, disodium hydrogen phosphate, sodium dihydrogen phosphate, sodium chloride 0.5mL/dose, two doses given 14 days apart.
15783896|NCT04582331|Other|Smartphone-based voice and self-reported symptom collection|Voice samples and COVID-19 symptom inventories will be collected on participant smartphone devices. No outcomes or feedback is provided on acquired data during trial conduct but will be used for confirmatory data analysis post study
15783897|NCT04582318|Biological|NGM621|NGM621 will be administered via IV infusion
15783898|NCT04582318|Biological|Placebo|Placebo will be administered via IV infusion
15783899|NCT04582305|Drug|Bleomycin|Intralesional bleomycin treatment administered with an electronic pneumatic jet injector
15783900|NCT04582305|Drug|Normal saline|Intralesional placebo treatment of normal saline administered with an electronic pneumatic jet injector
15783901|NCT04582279|Diagnostic Test|Lung ultrasound|The lung ultrasound will be performed by a trained pulmonologist by gently pressing a probe to various areas of your chest. This is a non-invasive procedure and you should not feel any pain. The ultrasound will take less than 10 minutes.
15783903|NCT04582253|Diagnostic Test|Scheimpflug Camera Corneal Tomography|Pentacam Sheimpflug system(Pentacam HR, Oculus Optikgeräte GmbH, software V.1.15r4 n7) is used for imaging of the anterior and posterior surfaces of the cornea to obtain corneal tomographic maps.
15783904|NCT04582240|Other|no intervention|no intervention
15783905|NCT04582227|Device|Ambu aura-i LMA|The ETT or the LMA will be inserted with the patient's head position is aided either by pins or head rest, and either the head will be in neutral position or tilted as long as the airway device is successfully placed.
15783906|NCT04582214|Device|MetaNeb® System|The intervention device use in this study is The MetaNeb® System (Hill-Rom; St. Paul, MN). It is an FDA 510k cleared device (k124032), powered by compressed gas, that delivers oscillation and lung expansion (OLE) therapy using both continuous high-frequency oscillation (CHFO) and continuous positive expiratory pressure (CPEP). The device also provides supplemental oxygen when used with compressed oxygen and can deliver aerosol therapy during CPEP and/or CHFO. The therapy is indicated for mobilization of secretions, lung expansion therapy and the treatment and prevention of pulmonary atelectasis. The device also provides supplemental oxygen when used with compressed oxygen.
15783907|NCT04582201|Drug|agenT-797|agenT-797 is an off-the shelf cell therapy consisting of ≥ 95% allogeneic human unmodified iNKT isolated from 1 healthy donor mononuclear cell apheresis unit and expanded ex-vivo.
15783908|NCT04582175|Procedure|angioplasty|angioplasty of all non-culprit lesions
15783909|NCT04582162|Other|Unsplinted implants|Patients received ball abutments on each implant without splinting for retaining an implant retained mandibular overdenture.
15783910|NCT04582162|Other|Splinted implants|Patients had their implants splinted using Rhein bars with ball extension for retaining an implant retained mandibular overdenture.
15783911|NCT04582149|Device|EyeControl Eye-tracking Device|The EyeControl is a new, wearable, eye-tracking device that facilitates communication by means of internal feedback to the patients with a bone-conducting speaker. In this way, the device can ask the patient what he or she wants to say, and the patient replies by eye gestures such as blinking or moving the eyes in a certain direction. Once the patient is able to operate the device, it will stay on the patient for as long as she or he would like it on, or until the patient is successfully extubated or discharged from the ICU, whichever is earliest.
15783912|NCT04582136|Drug|Sirolimus|In the double-blinded phase, sirolimus 1.5mg/day plus SOC is administered throughout 24 weeks; in the open-label extension period, patients who opt to participate continue on sirolimus 1.5mg/day plus SOC for an additional 24 weeks.
15783913|NCT04582136|Drug|Placebo|In the double-blinded phase, placebo plus SOC is administered throughout 24 weeks; in the open-label extension period, patients who opt to participate are switched to receive sirolimus 1.5mg/day plus SOC for an additional 24 weeks.
15783914|NCT04582123|Procedure|crossed pin configuration|comparison of two crossed pin fixation methods
15783915|NCT04582110|Diagnostic Test|Optical coherence tomography angiography|Each subject underwent Optical coherence tomography angiography (a non-invasive, fast, diagnostic imaging technique)
15783916|NCT04582097|Drug|Ramipril|angiotensin-converting enzyme inhibitor
15783917|NCT04582097|Drug|placebo|same odor, color and size as the drug but without the active ingredient
15783918|NCT04582084|Drug|Etanercept|Patients received biosimilar etanercept 25 mg twice weekly or 50 mg once weekly.
15783919|NCT04582071|Behavioral|Psychotherapy|Psychotherapy is a term that we use to describe the use of the psychological method to understand and improve an individual's well-being and mental health. The Principal Investigator of this study, a clinical psychologist will be leading each of the sessions.
15783922|NCT04582032|Drug|Dexketoprofen (KETAVEL 50 mg/2 ml)|intravenous dexketoprofen (KETAVEL 50 mg/2 ml)
15783925|NCT04582006|Procedure|Bariatric surgery|Surgical treatment of morbid obesity.
15783926|NCT04581993|Dietary Supplement|Super Cereal - wheat soya blend with sugar|Pregnant and lactating women will received Super Cereal during pregnancy and first six months of lactation.
15783927|NCT04581993|Dietary Supplement|Lipid-based nutrient supplement-medium quantity (LNS-MQ)|Children will receive LNS during 6-23 months of age.
15783928|NCT04581993|Behavioral|Social and behavior change communication (SBCC)|SBCC will be provided to improve care-givers knowledge, attitudes and practices related to infant and young child feeding.
15783930|NCT04581967|Genetic|polymorphism analysis|"DNA will be purified from whole blood samples by commercial DNA isolation kits.
~Genotyping and genetic polymorphism detection for some metabolic enzymes genes will be performed by real time PCR."
15783931|NCT04581967|Drug|Doxorubicin-Cyclophosphamide regimen|Treatment with a combination of Doxorubicin and Cyclophosphamide, This regimen comprises 60 mg/m² Doxorubicin and 600 mg/m² Cyclophosphamide administered intravenously on day 1 of each 21-day cycle, and repeated for a total of four cycles.
15783932|NCT04581954|Drug|Ruxolitinib|Ruxolitinib is a Janus kinase 1 (JAK1)/Janus kinase 2 (JAK2) inhibitor approved for clinical use in the treatment of splenomegaly, myelofibrosis, polycythaemia vera and graft-versus-host disease. It is an oral agent with a rapid mode of action.
15783933|NCT04581954|Drug|Fostamatinib|Fostamatinib is a tyrosine kinase inhibitor with activity against spleen tyrosine kinase (SYK). It has approved for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP).
15783934|NCT04581954|Other|Standard of care|Standard of care treatment as per site-level policies and guidelines.
15783935|NCT04581915|Drug|Triazavirin (Riamilovir)|Capsule - 250mg 8 hourly po
15783936|NCT04581915|Other|Placebo|Placebo capsule
15783937|NCT04581902|Device|rTMS therapy|rTMS treatment parameters will be determined by TMS care providers. Typical TMS settings for MDD involve rTMS applied at 10 Hz with an intensity of 120 % of resting motor threshold. Forty trains of 4 s duration with 11s of trains is typically applied (3000 pulses per day), resulting in approximately 90,000 pulses in a given treatment course.
15783938|NCT04581889|Other|Diagnostic test|Presence of antibodies in saliva
15783939|NCT04581876|Drug|raltitrexed for injection|Patients receive raltitrexed 2mg/m2 (iv, 15min) on day 1 and day 15, q4w. Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity, death or begin a novel treatment.
15783940|NCT04581876|Drug|nab-paclitaxel|Patients receive nab-paclitaxel at 125 mg/m2 on day 1 and day 15, q4w. Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity, death or begin a novel treatment.
15783941|NCT04581863|Device|pulse oximeter|Patients will be prompted twice daily to text their oxygen saturation level after walking in place for 1 minute. If the oxygen saturation is >3% lower than than the baseline first O2 sat measurement, or if it falls below an absolute level of 90%, the patient will receive an immediate call from the same on-call RN's for COVID Watch and undergo the same triage protocol .
15783942|NCT04581863|Other|COVID Watch|Enrolled patients receive text-based assessments, two times a day for 14 days and escalates care to a nurse via telemedicine for any reported worsening of symptoms not severe enough to recommend going to the ED immediately.
15783943|NCT04581850|Behavioral|Sleep recording|Sleep is recorded at home during 7 nights in a row using a connected headband. The participant also has to fill in a sleep agenda every day.
15783944|NCT04581850|Behavioral|Cognitive tasks|Working memory and inhibition capacity is assessed during computer-based tasks (2-back and Go/No-Go tasks) at enrollment and 1 month after enrollment.
15783945|NCT04581850|Other|Questionnaires|"The participant has to fill in several questionnaires at enrollment and 1 month after enrollment in order to assess:
~PTSD severity
~chronotype
~Sleep quality
~Daytime sleepiness
~Mood state
~Depression
~Mental disorders and their consequences"
15783946|NCT04581837|Diagnostic Test|2D-speckle tracking echocardiography|Two-dimensional speckle tracking echocardiography (2D-STE) allows for an angle-independent evaluation of myocardial strain, and provides comprehensive information on LV myocardial contractility. Thus, 2DSTE is superior in detecting subtle deteriorations of contractility. we will take 2D speckle tracking views for LV and RV strain (4ch, 2ch, 3ch, RV modified view).
15783950|NCT04581811|Other|Prolonged Proned Positioning|Patients will be placed in the prone position for 24 hours followed by 8 hours supine for consecutive periods for the duration of the study period
15783951|NCT04581811|Other|Traditional Proning Arm|Patients will be placed in the prone position for 16 hours followed by 8 hours supine for consecutive periods for the duration of the study period
15783952|NCT04581785|Biological|hLB-001|hLB-001 via IV infusion
15783953|NCT04581772|Drug|DNL343|Multiple oral doses
15783954|NCT04581772|Drug|Placebo|Single oral dose
15783955|NCT04581772|Drug|DNL343|Single oral dose
15783956|NCT04581759|Device|RIPC device (IPC-906X)|Patients in the RIPC group will have five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm twice a day after Mechanical Thrombectomy.
15783957|NCT04581759|Drug|foundational treatment|foundational treatment, including free radical elimination in the acute stage, blood pressure and blood glucose stabilization, and antiplatelet (aspirin or/and clopidogrel ) and lipid-lowering (statins) drugs
15783958|NCT04581746|Other|questionnaire|bi-monthly questionnaire and then one visit with questionnaire and covid-19 test
15783959|NCT04581733|Drug|MT1621|All patients will receive MT1621 up to a target dose of 400 mg/kg/day each dC and dT, as tolerated.
15783960|NCT04581720|Device|Train-of-four (TOF)|Give 4 electrical stimulants on the ulnar nerve to see if the 4 responses (T1 ~ T4) of adductor pollicis fade or not. If there's no neuromuscular block, it shows no fade, or it fades. When an operation is over under general anesthesia, we use the ratio of the height of T4 to T1, and the ratio is over 90%, the neuromuscular block is recovered enough to extubation.
15783961|NCT04581707|Device|Kyphoplasty Single Balloon Catheter Allevo|Vertebral compression fractures treated with Kyphoplasty Single Balloon Catheter Allevo (Joline®) and BonOs® Inject bone cement
15783962|NCT04581707|Device|Quattroplasty Double Balloon Catheter Stop'n GO|Vertebral compression fractures treated with Stop'n GO double balloon kyphoplasty system (Joline®) and BonOs® Inject bone cement
15783963|NCT04581694|Diagnostic Test|TAVI without contrast|TAVI without contrast
15783964|NCT04581681|Behavioral|Group Cognitive Behaviour Therapy for Perinatal Anxiety (CBT-PA)|"The 6-session group CBT intervention for perinatal anxiety has been formalized with session guides for the facilitators and a workbook, Overcoming Anxiety in Pregnancy and Postpartum (Furer & Reynolds, 2015), developed by members of our Anxiety Disorders Clinic. There are 6 core modules covered over the 6 treatment sessions, including: (1) Understanding anxiety during pregnancy and postpartum, (2) self-care, (3) setting goals and facing fears, (4) nurturing the developing relationship with baby, (5) coping with negative thoughts and worries, and (6) relapse prevention. Content is based on general principles of CBT for anxiety but specific themes and examples are geared towards the pregnancy and postpartum periods. Distorted cognitions are also explored, with an additional focus on beliefs about motherhood and perfectionism. Due to the COVID-19 pandemic, the intervention will be conducted via a hospital-approved video-conferencing platform."
15783965|NCT04581681|Other|No treatment (waitlist control)|Patients in this condition are randomly assigned to a waitlist control condition before receiving treatment.
15783966|NCT04581668|Other|Neurally adjusted ventilatory assist first|Invasive ventilation in Neurally adjusted ventilatory assist during 60 minutes followed by a 30 minutes wash out period then ventilation in conventional mode
15783967|NCT04581668|Other|Conventional ventilation first|Invasive ventilation in conventional mode during 60 minutes followed by a 30 minutes wash out period then ventilation in Neurally adjusted ventilatory assist
15783968|NCT04581642|Device|PMD200|The NOL technology is comprised of a console and designated finger probe with 4 sensors. The Sensors are Photoplethysmography (PPG) Galvanic Skin Response (GSR), Accelerometer (ACC) and Thermistor (TMP)
15783969|NCT04581629|Drug|CLTX-305|"Period 1: Once daily, followed by twice daily of CLTX-305 for 5 days
~Period 2: Twice daily doses of CLTX-305 for 5 days
~Period 3: Individualized dose titration of CLTX-305 for up to 24 weeks
~LTE: Individualized dose titration of CLTX-305 for up to 25 months"
15783970|NCT04581616|Procedure|Intrathoracic Intercostal Nerve Block|Injection of local anesthetic into the subcostal groove, to achieve analgesia for chest region.
15783971|NCT04581616|Procedure|Erector Spinae Plane Block|Injection of local anesthetic in the plane deep to the erector spinae muscles and superficial to the transverse processes, to achieve analgesia for chest region.
15783972|NCT04581603|Drug|Topiramate (TOP)|This intervention will consist of patients stabilized on topiramate (TOP) for 6 weeks up to a final dose of 200 mg per day or less and treated. The subjects will continue on TOP for the next 8 weeks of behavioral sleep treatment.
15783973|NCT04581603|Behavioral|Cognitive Behavioral Therapy for Insomnia|CBT-I is conducted weekly for eight sessions during which the subjects meet individual with the study clinician for 45 minutes on the first session and for 30 minutes for sessions 2-8. Session 1 serves as an orientation and the onset of Sleep Restriction Therapy. Sessions 2 & 3 deliver the three main components that include, Sleep Restriction Therapy, Stimulus control, and Sleep Hygiene. All the sessions excluding the last two sessions are dedicated to the titration of total sleep time and to ensure patient adherence. The fifth session is used to deliver a specific form of cognitive therapy. The final session is used to engage the patient in a relapse-prevention didactic (i.e., to review how insomnia becomes chronic and strategies that abort an extended episode of insomnia).
15783974|NCT04581603|Behavioral|Sleep Hygiene Education|This non-active control arm of behavioral sleep intervention consists of psychoeducation on sleep hygiene, sleep-related disturbances, and the effects of stress on sleep that will be delivered weekly for 8 weeks, for a time duration that is identical to the CBT-I sessions. The effect of stress on sleep is a commonly used control condition in insomnia clinical trials. SHE is preferred to a monitor-only condition as it will control for contact with the therapist and elapsed time during sessions.
15783975|NCT04581590|Other|Cognitive training|Both groups will undergo the motor training where only the type of received electric current is varied (active or simulated sham type) associated cognitive training. The twelve sessions will be performed in three sessions per week for 30 minutes.
15783976|NCT04581577|Other|Semi-structured telephone questionnaire|Semi-structured telephone questionnaire
15783977|NCT04581564|Device|Rhythm-based speech therapy app (i.e., Speech Hero)|Patients with non-fluent aphasia will practice speech production during the intervention period.
15783978|NCT04581551|Procedure|SWE assessor 1|"SWE for 6 shoulder muscles will be performed.
~m. supraspinatus
~m. infraspinatus
~m. rhomboideus major
~m. deltoideus
~m. pectoralis major
~m. pectoralis minor"
15783979|NCT04581551|Procedure|SWE assessor 2|"SWE for 6 shoulder muscles will be performed.
~m. supraspinatus
~m. infraspinatus
~m. rhomboideus major
~m. deltoideus
~m. pectoralis major
~m. pectoralis minor"
15783980|NCT04581551|Procedure|Stretch intervention|Transversal stretch of pectoralis major muscle on the hemiplegic side.
15783981|NCT04581551|Procedure|No stretch intervention|Passive mobilisation of the hemiplegic hand.
15783982|NCT04581538|Device|Intervention of parallel arm 2|"This intervention consists of the e-learning platform and the networking platform from the newly developed client-server software solution 24-h-QuAALity.
~The e-learning platform offers concise evidence-based information on common clinical patterns, as well as examples of assistance, physical activity, nutrition and daily routine provided in the caregivers' mother tongues.The caregivers use the e-learning content according to the needs of their clients and their caring skills. After completing the e-learning courses they do a test to prove their knowledge.
~The networking platform supports caregivers in communicating with other caregivers and relatives of the care receiver, with special consideration of language barriers. The caregivers use the networking platform primarily to get information or exchange it, if there are uncertainties in the care."
15784013|NCT04581317|Other|meals|Participants will receive meals delivered to them by the Meals oN wheels(MOW) program for 6 weeks.
15783983|NCT04581538|Device|Intervention of parallel arm 3|"Intervention Description: This interventions represents the entire 24-h-QuAALity package consisting of the e-learning platform and networknig platform as specified under intervention 1 and the digital care documentation from the newly developed client-server software solution 24-h-QuAALity.
~The digital care documentation aims at supporting caregivers in managing their daily tasks and facilitates exchange with other health professionals and palliative supply. The caregivers use the care documentation every day. They describe the caring and household activities they have done by their clients. The integrated emergency management empowers caregivers with lifesaving first aid skills and knowledge including an integrated voice communication and emergency call system. The emergency management system is used by caregivers when an emergency happens in which life-threatening diseases have to be managed."
15783984|NCT04581525|Device|transcranial direct current stimulation|
15783986|NCT04581499|Combination Product|DynamiCare Motivation Support Program|DynamiCare is an evidence-based, multi-service platform that combines software, smartphone and pocket-sized alcohol and drug testing hardware, and recovery services, designed to remotely deliver evidence-based methodologies to facilitate people's motivation and accountability to overcome alcohol, nicotine and other drug use disorders, whether in formal treatment or not.
15783987|NCT04581499|Other|Untreated or Routine Care Control Group|No specific intervention, i.e., research participation plus any community-based treatment the individual seeks to obtain.
15783988|NCT04581486|Other|Optimal-Massive Intervention|Multimodal intervention based on 3 main measures: a) optimal fluid viscosity adaptation (with Nutilis Clear®), b) optimal nutritional support with a triple adaptation of food (texture, (Nutilis Clear®)) caloric and protein content, organoleptic) + ONS depending on nutritional status and evaluation and c) optimal treatment of oral hygiene (tooth brushing + antiseptic mouthwash + professional dental cleaning).
15783989|NCT04581486|Other|Control (standard clinical practice)|Standard clinical practice (fluid adaptation with Nutilis Powder® and simple texture adaptation (for solids (Nutilis Powder®))
15783990|NCT04581473|Drug|CT041 autologous CAR T-cell injection|1-3 CT041 autologous CAR T-cell injection infusion
15783991|NCT04581460|Other|Questionnaire|Questionnaire intended for patients on the course of pregnancy and postpartum, the neonatal period and contraceptive modalities.
15783992|NCT04581447|Drug|Metformin|Metformin will start at dose of 850 mg once daily and, at one month increased to 850 mg twice daily
15783993|NCT04581447|Other|Standard Care|Standard Care
15783994|NCT04581434|Behavioral|Prolonged Exposure Therapy|Prolonged Exposure Therapy is an individually-delivered treatment for PTSD that includes in vivo exposure to trauma reminders and imaginal exposure to the trauma memory delivered in 90-minute weekly sessions.
15783995|NCT04581434|Behavioral|Cognitive Processing Therapy|Cognitive Processing Therapy is an individually-delivered treatment for PTSD that focuses on challenging and modifying maladaptive beliefs related to the trauma, with an optional written trauma account during weekly 60-minute sessions
15783996|NCT04581434|Behavioral|Present Centered Therapy|"Present Centered Therapy is an individually-delivered treatment for PTSD that focuses on current life problems as manifestations of PTSD in weekly 60-minute sessions. It includes psychoeducation and normalization of responses to trauma, problem solving related to current life difficulties and stress identified by patients, and emotional support and validation"
15783997|NCT04581421|Other|High Carb Low Fat Diet|The participants will be randomized to a diet of low carb/ high fat og high carb/low fat
15783998|NCT04581421|Other|Low Carb High Fat Diet|The participants will be randomized to a diet of low carb/ high fat og high carb/low fat
15783999|NCT04581408|Drug|Lumacaftor / Ivacaftor, Orkambi® Oral Tablet|"Total daily dose: 800 mg of Lumacaftor and 500 mg of Ivacaftor.
~Duration of treatment: according to the clinical conditions of the patient and based on the response to the drugs: up to a maximum of 7 days"
15784000|NCT04581395|Other|non-pretreated Succinylcholine|no pretreatment
15784001|NCT04581395|Drug|succinylcholine 1 minute after rocuronium pretreatment|0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 1 min +/- 10 sec after pretreatment
15784002|NCT04581395|Drug|succinylcholine 2 minutes following rocuronium pretreatment|0.05 mg/kg up to 5 mg of rocuronium pretreatment followed by 1.0 mg/kg succinlycholine t = 2 min +/- 10 sec after pretreatment.
15784003|NCT04581382|Biological|Nivolumab|Given IV
15784004|NCT04581382|Biological|Pembrolizumab|Given IV
15784005|NCT04581382|Radiation|Radiation Therapy|Undergo radiation therapy
15784006|NCT04581382|Biological|Therapeutic Exchange Plasma|Undergo therapeutic plasma exchange
15784010|NCT04581356|Drug|Voxelotor|daily voxelotor 1500mg oral medication
15784011|NCT04581343|Drug|Canakinumab injection; spartalizumab, nab-paclitaxel, gemcitabine|Canakinumab 250 mg s.c. injection; Spartalizumab 400 mg IV infusion, nab-paclitaxel 125 mg/m2 IV infusion, gemcitabine 1000 mg/m2 IV infusion
15784012|NCT04581330|Device|DEKA SmartXide C02 laser|One pass with a 1-mm spot density and a 60 micron depth will be performed followed by a 1-mm spot density and a 200 micron depth will be used
15784014|NCT04581317|Other|AES 8 basic usage|For the second 6 weeks, participants will continue to have meal deliveries and will now have the AES 8 device which can be used by the cognitively impaired participant and their caregiver. AES 8 devices will be installed in participant's homes by the study team and participants will be given basic instructions on using the device as well as a one-page handout that will include instructions on how to use and maintain privacy with their device. The study staff will continue to call twice a week to ask the 5 questions. At the end of the 6 weeks, a study team member will make an in-person visit to the participants' homes to measure FFP, MHS, CES-D, MOCA, ADL/IADLs, NSI, ZCBI, and TAM.
15784015|NCT04581317|Other|AES 8 advanced usage|In the third 6 weeks, the participants will continue to have meal deliveries and the AES 8 will be upgraded to provide an active intervention by asking the twice a week 5 questions through the device. The questions should be answered by the cognitively impaired older adult using the device, though the caregiver can still use the device for other basic services. The participant will be able to answer the questions verbally or by touch screen options displayed on the device.At the end of the 6 weeks, a study team member will make an in-person visit to the participants' homes to measure FFP, MHS, CES-D, MOCA, ADL/IADLs, NSI, ZCBI, and TAM.
15784016|NCT04581304|Device|Geistlich Bio-Oss® Collagen|Geistlich Bio-Oss® Collagen is intended to be used for filling bone defects and for bone augmentation.
15784017|NCT04581304|Device|Geistlich Bio-Oss® Granules|Geistlich Bio-Oss® Granules is intended to be used for filling bone defects and for bone augmentation.
15784018|NCT04581291|Other|Moderate Intensity Aerobic Exercises|Participants in the exercise group performed a two weeks aerobic exercise program. The exercise program consisted of walking/running on a treadmill or bicycling on a stationary bicycle. Each session is composed of five-minute warm-up slow walking or bicycling. Then the main intervention which composed of thirty-minutes of moderate-intensity aerobic exercises (walking/running or bicycling). Lastly, a five-minute of cool-down exercises (walking/running or bicycling). The exercise intensity was 60-75% of the predicted MHR (calculated as MHR=210-age).
15784019|NCT04581278|Diagnostic Test|KTD Innov-2|"The main objective of the present study (KTD Innov-2) is to validate the feasibility of SDI within a limited time frame to ensure its clinically relevant use, with a high level of evidence to consider its labelling as a medical device by health authorities prior to routine transfer and/or future marketing.
~300 kidney transplant patients will be included in the KTD Innov-2 study with data collection, blood, urine and graft biopsies for biomarker analysis and conversion to SDI (decisional algorithms) and interactive multi-dimensional presentation on a web interface for use of the tool by transplant physicians and their patients."
15784020|NCT04581265|Drug|albumin-bound paclitaxel (nab-PTX), ifosfamide and cisplatin|Participants received a single dose of albumin-bound paclitaxel (nab-PTX) 270mg/m2/d, administered intravenously (IV) on Day 1; Ifosfamide 1.2g/m2/d administered intravenously (IV) on Day 2-6; Cisplatin 20mg/m2/d administered intravenously (IV) on Day 2-6.
15784021|NCT04581252|Device|Non-invasive cardiac system|Non-invasive cardiac system
15784022|NCT04581239|Other|Active neural mobilization|"Active neural mobilization Base line treatment followed heating pad 10 minutes, lumber traction with 50 %of body weight in accordance with tolerance. 15 to 20 Lumber segmental mobilization.
~Active oscillatory nerve mobilization was given in 3 sets of 10 repetition in each set with 20 sec rest time between set"
15784023|NCT04581239|Other|passive neural mobilization|"Base line treatment followed heating pad 10 minutes, lumber traction with 50 %of body weight in accordance with tolerance. 15 to 20 Lumber segmental mobilization
~Passive neural mobilization This oscillatory nerve mobilization was given in 3 sets of 10 repetition in each set with 20 sec rest time between set. Both groups received total 18 session 3 session per week for consecutive 6 weeks"
15784024|NCT04581226|Diagnostic Test|Lung ultrasound|All children will be studied in the supine position. LUS will be performed with the portable device MicroMax (Sonosite, Bothell, Washington, USA) using a linear probe of 6 to 12 MHz. All ultrasound scans will be performed by the same anesthetist, who has experience of more than 30 lung ultrasound scans in pediatric patients. Each hemithorax will be divided into six regions, using three longitudinal lines (parasternal, anterior and posterior axillary) and two axial lines (one above the diaphragm and the other 1 cm above the nipples)
15784025|NCT04581213|Procedure|General anesthesia|Children under general anesthesia for an elective surgery, aged between 6 months and 5 years old, ASA 1-2.
15784027|NCT04581187|Other|Quality of life assessment|Quality of life questionnaires
15784028|NCT04581174|Diagnostic Test|24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values <5.5 will be evaluated|Patients with the 1st degree of hypertrophy according to Camacho, 2nd degree of hypertrophy according to Camacho, 3rd degree of hypertrophy according to Camacho, 4th degree of hypertrophy according to Camacho will undergo 24-hour monitoring of oropharyngeal pH by Restech, RYAN scores upright and supine, and pH values <5.5 will be evaluated.
15784029|NCT04581161|Device|Life2000® Ventilator|"POV support (Life2000) will be administered in six (6) to ten (ten) enrolled subjects based on clinical protocol flowchart (Appendix C). Specifically, if it is determined that a COVID-19 subject who would currently be considered for HFNC under current standard of treatment, will be eligible for POV treatment.
~The prescribed therapy regimen, including duration of therapy will be documented and COVID-19 patients who fail therapy and require IMV will be recorded."
15784031|NCT04581135|Other|COVID-19|Research project in which biological material is sampled and health-related personal data are collected and used for further research. Coded data are used.
15784032|NCT04581122|Procedure|Lymphadenectomy|Patients with ground glass nodules smaller than 3cm and with more than 50%solid components would randomly assigned to selective lymphadenectomy group or systematic lymph node dissection group
15784033|NCT04581109|Biological|Blood sample|Twenty ml of blood will be drawn from each patient : 10 ml of blood will be drawn on CellSave tubes (fixed cells) for CTC detection using the FDA-cleared CellSearch system (gold standard) and 10 ml of blood will be drawn on EDTA tubes (viable cells) for the detection of functional CTCs using the EPIDROP.
15784034|NCT04581096|Other|no intervention|just descriptive analysis of clinical data
15784137|NCT04580134|Drug|clozapine|Biotype 1 and Biotype 2
15784035|NCT04581083|Diagnostic Test|RT-PCR|RT-PCR (Gold standard): Real-time PCR testing with reverse transcriptase (RT-PCR). The test consists of a polymerase chain reaction that has previously had a reverse transcription phase, RT. This test allows the cADN (complementary DNA) to be obtained from a RNA chain. This technique allows the detection and amplification of a sequence from a strand of RNA.
15784036|NCT04581083|Diagnostic Test|LAMP|LAMP: The LAMP technique, like PCR, has the ability to amplify specific DNA fragments (target sequence), allowing for highly sensitive detection of pathogens. Unlike pcr, LAMP requires between 4 and 6 feeders, external F3 and B3 feeders, which hybridte with the outer regions of the target sequence, while the internal FIP and BIP have sequences in both ways that allow the formation of a loop. The LAMP reaction is isothermal, i.e. it takes place at a single temperature. LAMP has been successfully used to detect viral diseases as well as viral pathogens such as West Nile virus, TMR-1, Norovirus, avian influenza, foot-and-mouth disease, classical swine fever, among others.
15784037|NCT04581083|Diagnostic Test|POOL RT-PCR|POOL RT-PCR: This test aims to mix in a single sample the extractions obtained from several people. The joint sample is evaluated and, if negative, it is understood that all are free of COVID-19; if it is positive, an array system is used to detect the affected person. That is, a single PCR (polymerase chain reaction), the diagnostic test used to detect the virus pathogen is applied to a group and repeated individually if positive.
15784038|NCT04581083|Diagnostic Test|POOL LAMP|POOL LAMP: Like the RT-PCR pool test. This test essentially involves mixing in a single sample the extractions obtained from several people. This joint sample is tested and, if it is negative, it is understood that everyone is free of COVID-19; if it is positive, an array system is used to detect the affected person. That is: a single LAMP applies to a group
15784039|NCT04581057|Biological|Specific blood sampling|"A 30 ml blood sample (6 EDTA tubes) will be taken at inclusion in the study, in addition to the blood sample taken as part of the routine care.
~This sampling is carried out for :
~Search for CHIP-associated mutations in circulating leukocytes
~Plasma determination of IL-1β, IL-6, IL-10 and TNF-α"
15784040|NCT04581031|Device|Continuous vital sign monitoring - Isansys Patient Status Engine|CE marked wearable continuous vital signs monitors
15784041|NCT04581031|Other|Machine Learning/AI Algorithm|Patient data will be subjected to machine learning/AI algorithms to determine whether algorithms may be beneficial as an early indication of patient's condition worsening.
15784042|NCT04581018|Other|Health supplements|28 days of health supplements (synbiotic), 4g daily
15784043|NCT04581005|Behavioral|Prehabilitation|Endurance and Resistance Exercise, Nutrition therapy, reducing intervention during the whole preoperative period
15784044|NCT04580992|Drug|Ajmaline|Ajmaline administration
15784045|NCT04580979|Genetic|Mutation analysis|The investigators will sequence DNA samples from the patients or their families.
15784046|NCT04580966|Behavioral|Inquiry Based Stress Reduction (IBSR) workshop|The IBSR intervention workshop included weekly group meetings (3.5 hours/meeting) for 12 weeks. During the workshop, participants were encouraged to identify and inquire their stressful thoughts. Using self-inquiry practices participants were taught to increase awareness of their thoughts and feelings, to observe their emotional and physical responses during situations perceived by them as stressful, and allow their mind to return to its true, peaceful, creative nature. Through the process of self-inquiry, participants took an active role in investigating their stressful thoughts, and by this regulated their stress and managed symptoms and emotions, thus enabled them to cope better with the psycho-social consequences of the stuttering.
15784047|NCT04580953|Device|CardiaCareTM RR2|Treatment with CardiaCareTM RR2
15784048|NCT04580940|Device|SpyGlass™ Discover Digital System|Observational, prospective, registry study for the clinical utility of the SpyGlass Discover digital catheter during a PTCS procedure.
15784049|NCT04580927|Behavioral|Breastfeeding self-efficacy (BSE)|Self-efficacy is determined by factors such as prior experience, vicarious learning, persuasion of others and physiological state, which in turn impact on one's behaviours and actions. One's sense of self-efficacy is modifiable, and can be readily targeted for intervention. An increasingly studied key determinant of breastfeeding outcomes is breastfeeding confidence, also referred to as breastfeeding self-efficacy (BSE). The investigators will use a nurse-administered validated BSE intervention tool.
15784050|NCT04580914|Device|Treatment with IntellaNav StablePoint Ablation Catheter|Patients will be treated with an ablation catheter
15784051|NCT04580901|Behavioral|Group Interpersonal Psychotherapy|15 sessions over 12 weeks of group IPT taking place virtually via Zoom (2 sessions per week for the first 6 weeks (acute phase) then every other week for 6 weeks (maintenance phase)
15784052|NCT04580888|Procedure|early transthoracic echocardiography|In the intervention arm, echocardiography will be performed immediately and potentially repeated to confirm the need for additional fluid resuscitation up to 30 mL/kg in the presence of persisting hypovolemia, or not (e.g., severe ventricular dysfunction). A therapeutic algorithm will allow standardized impact on ongoing management according to the hemodynamic profile identified by early echocardiography. After the completion of initial fluid resuscitation up to 30 mL/kg if required, a new echocardiographic assessment will be systematically performed by the same operator to stop or not fluid resuscitation, and to potentially initiate another treatment according to both the hemodynamic profile and clinical context.
15784053|NCT04580888|Procedure|standards of care|In the control arm, patients will be treated according to standards of care based on current SSC recommendations, including a fluid resuscitation of 30 mL/kg.
15784054|NCT04580875|Procedure|Minimally invasive surgery (laparoscopy and laparoscopic-assisted procedures) in both diagnosis and treatment of penetrating abdominal trauma in Children|
15784055|NCT04580862|Other|Non-surgical endodontic retreatment in single visit|Full medical and dental history using a schematic dental chart, will be obtained from all patients treated during this study.
15784056|NCT04580849|Other|telerehabilitation with dance|Dance classes will be provided through a online platform. Each class will last 60 minutes, twice a week, during 8 weeks.
15784057|NCT04580836|Procedure|Magnetic Resonance Imaging|Undergo MRI
15784058|NCT04580836|Other|Questionnaire Administration|Ancillary studies
15784059|NCT04580836|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15784060|NCT04580823|Dietary Supplement|Fasting with exogenous ketone salt supplement|Participants will have to take 2 doses of supplement, one 75 minutes before the scan and one 30 minutes before the scan.
15784138|NCT04580134|Drug|risperidone|Biotype 1 and Biotype 2
15784061|NCT04580823|Dietary Supplement|Post-Prandial with exogenous ketone salt supplement|Participants will have to take 2 doses of supplement, one 75 minutes before the scan and one 30 minutes before the scan and they will have a liquid meal 20 minutes before the scan.
15784062|NCT04580810|Behavioral|CBT4CBT in the Black Church|Use of Computer Based Treatment for Cognitive Behavioral Therapy for alcohol use disorder offered in a Black church setting
15784063|NCT04580797|Drug|PF-06700841 IR|Immediate release formulation
15784064|NCT04580797|Drug|PF-06700841 MR1|Modified release formulation 1
15784065|NCT04580797|Drug|PF-06700841 MR2|Modified release formulation 2
15784066|NCT04580797|Drug|PF-06700841 MR3|Modified release formulation 3
15784067|NCT04580797|Other|Placebo|Matching placebo
15784068|NCT04580784|Radiation|Weekly hypofractionation for early breast cancer|Testing the feasibility of a hypofractionated adjuvant radiotherapy regimen after breast surgery on a-once-weekly basis for a total dose of 28.5Gy in 5 fractions over 5 weeks
15784069|NCT04580771|Drug|Cisplatin|Given IV
15784070|NCT04580771|Biological|Liposomal HPV-16 E6/E7 Multipeptide Vaccine PDS0101|Given SC
15784071|NCT04580771|Radiation|Radiation Therapy|Undergo radiation therapy
15784072|NCT04580758|Combination Product|Fractional laser with PRP fluid or PRP gel|20 participants divided into 2 groups of 10 10 participants will do Fractional laser with PRP fluid sessions and 10 participants will do Fractional laser with PRP gel
15784073|NCT04580745|Drug|MORF-057|"SAD: Subjects will be assigned to one of five planned dose cohorts and receive single doses of MORF-057.
~Food Effect: Subjects will receive single dose administration of MORF-057 in fed and fasted states.
~MAD: Subjects will be assigned to one of three planned dose cohorts and receive multiple doses of MORF-057."
15784074|NCT04580745|Drug|Placebo for MORF-057|"SAD: Subjects will be assigned to one of five planned dose cohorts and receive single doses of placebo.
~MAD: Subjects will be assigned to one of three planned dose cohorts and receive multiple doses of placebo."
15784075|NCT04580732|Device|Moventis PNS|Moventis PNS is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin.
15784076|NCT04580706|Other|this is an observational study with none intervention|this is an observational study with none intervention
15784077|NCT04580693|Other|PET Scan|PET scan using a tracer that is under a physician sponsored IND.
15784078|NCT04580680|Device|Commercial membrane for Extracorporeal Blood Purification Therapy (EBPT)|At each participating center, EBP treatments with commercial membranes will be delivered in accordance with local practice and local levels of expertise. Enrolled patients will not receive additional treatments other than those routinely administered in ICUs. Nonetheless, all parameters settings for EBP treatments will be recorded in the web-based registry and analyzed a posteriori to reveal potential correlations with patient outcomes.
15784079|NCT04580667|Other|Collection of plasma samples|Collection of plasma samples - Plasma samples are collected at different times during the study for the RadTox test.
15784080|NCT04580654|Biological|CSL312|Fully human immunoglobulin G4/lambda recombinant monoclonal antibody against Factor XIIa
15784081|NCT04580641|Other|Questionnaire|A self-administered questionnaire will be completed by each study subject
15784082|NCT04580615|Device|CardiacSense1 and capnograph Respiratory rate measurement|Inpatients Subjects with respiratory disease/impairment and Inpatients Subjects with no known respiratory disease/impairment will be measured simultaneously with both CardiacSense1 and capnograph for at least 30 minutes up to 24 hours. During this time capnograph data will be recorded in parallel to CardiacSense1.
15784083|NCT04580576|Procedure|Hematopoietic stem cell transplantation|Allogeneic or autologous bone marrow transplant
15784084|NCT04580563|Drug|OctaplasLG®|Patient receive 12 ml/kg of OctaplasLG® at day 1, within the 2 hours after randomization (i.e. within the 8 hours after coagulopathy diagnosis). A new identical dose will be infused at day 2 if prothrombin time is below 50%.
15784085|NCT04580563|Drug|0.9% NaCl|Patient receive 12 ml/kg of placebo (0.9% NaCl) at day 1, within the 2 hours after randomization (i.e. within the 8 hours after coagulopathy diagnosis). A new identical dose will be infused at day 2 if prothrombin time is below 50%.
15784086|NCT04580550|Other|Axial length variability|Biometry (axial length measurement)is performed using the IOL Master 700 (Carl Zeiss Meditec AG, Jena, Germany) and Heidelberg Anterion (Heidelberg Engineering, Germany) pre and postoperatively.
15784087|NCT04580537|Drug|Enstilar|Daily application on affected fingers (nail plates, nail folds, and surrounding skin)
15784088|NCT04580537|Device|Ablative fractional laser|Pre-treatment of affected fingers (nail plates, nail folds)
15784089|NCT04580524|Procedure|Repair of ventral hernia using biologic mesh|Ventral hernia will be repaired using biologic mesh
15784090|NCT04580524|Procedure|Repair of ventral hernia using suture repair or synthetic mesh|Ventral hernia will be repaired using the current treatment methods
15784091|NCT04580511|Device|CELLIS (Porcine Acellular Dermal Matrix, PADM)|Biological membrane used in abdominal reconstruction
15784092|NCT04580498|Drug|SHR-1701+Paclitaxel+carboplatin|Drug: SHR-1701 30mg/kg Drug: Paclitaxel 175mg/m2 Drug: Carboplatin AUC 5
15784093|NCT04580498|Drug|SHR-1701|Drug: SHR-1701 30mg/kg
15784094|NCT04580485|Drug|INCB106385|INCB106385 will be administered orally QD
15784095|NCT04580485|Drug|INCMGA00012|INCMGA0012 will be administered IV once every 4 weeks (Q4W)
15784096|NCT04580472|Drug|Cephalexin|If randomized to the antibiotic group, a single dose of cephalexin or clindamycin hydrochloride (if concern for previous allergy to Cephalexin) will be given prior to surgery.
15784097|NCT04580472|Other|Placebo capsules|Patients will receive 4 placebo capsules prior to surgery if randomized to placebo group.
15784098|NCT04580459|Behavioral|CARE Parenting Group Treatment|The CARE parenting group treatment is a 12-session, 60-minute group mentalizing-focused intervention with 3 monthly parent-child sessions.
15784099|NCT04580459|Behavioral|Treatment as Usual (TAU)|Treatment as usual (TAU) involves typical child outpatient mental health services, such as individual child appointments and medication management.
15784100|NCT04580446|Radiation|Hypofractionated intensity modulated radiotherapy|Hypofractionated intensity modulated radiotherapy with concurrent chemotherapy (weekly cisplatin)
15784139|NCT04580121|Drug|RO7283420|RO7283420 will be administered to participants by intravenous (IV) infusion Q3W at a starting dose of 0.15mg.
15784379|NCT04578067|Behavioral|Lifestyle intervention|on physical activity and healthier eating
15784101|NCT04580433|Behavioral|Time-Restricted Feeding|"The trial consists of a 1-week baseline weight stabilization period followed by a 5-week TRF intervention period.
~Participants will be instructed to eat freely from 8 a.m. to 4 p.m. daily and fast from 4 p.m. to 8 a.m. the next day."
15784102|NCT04580420|Drug|DCR-PHXC|Monthly dosing throughout study period
15784103|NCT04580407|Biological|TAK-672|B-Domain Deleted Recombinant Porcine Factor VIII
15784104|NCT04580394|Drug|AD109|Oral administration before bed
15784105|NCT04580394|Drug|Atomoxetine|Oral administration before bed
15784106|NCT04580394|Drug|R-oxybutynin|Oral administration before bed
15784107|NCT04580394|Drug|Placebo|Oral administration before bed
15784108|NCT04580381|Drug|Natalizumab Injection [Tysabri]|Natalizumab infusion interval according to local practice defining the patient's group
15784109|NCT04580368|Drug|CFTR Modulators|Participants with rare mutations will receive active therapy in N-of-1 design with participants serving as their own control
15784110|NCT04580355|Procedure|One-Stage Full Mouth Debridement|Periodontal debridement
15784111|NCT04580355|Drug|Amoxicillin 500mg|Administration of Amoxicillin 500mg prescribed on the day of treatment tid for 7 days.
15784112|NCT04580355|Drug|Metronidazole 400mg|Administration of Metronidazole 400mg prescribed on the day of treatment tid for 7 days.
15784113|NCT04580355|Drug|Amoxicillin Placebo|Administration of Placebo on the day of treatment tid for 7 days.
15784114|NCT04580355|Drug|Metronidazole Placebo|Administration of Placebo on the day of treatment tid for 7 days.
15784115|NCT04580342|Drug|oral Ivabradine|Ivabradine group will receive ivabradine 5mg PO in the evening and 1 hour before anesthetic induction
15784116|NCT04580342|Drug|oral Propranolol|propranolol group will receive propranolol 10 mg PO in the evening and 1 hour before anesthetic induction.
15784117|NCT04580329|Procedure|neuromuscular electrical stimulation (NMES) in addition to routine hospital care|"Patients in the NMES group will receive NMES sessions as the electrodes will be placed around the bilateral femoral quadriceps muscles and at the site of renal arteries.
~NMES(>100 Hz, 50-80 μ sec) will be performed for 55 min including 5 minutes for warm up and 5 minutes for recovery .
~The intensity of electrical stimulation will be adjusted to suit the comfort level of each individual patient without producing discomfort or pain."
15784118|NCT04580329|Procedure|routine hospital care without NMES|routine hospital care include all the routine intervention done for post partum women with AKI including fluid resuscitation, diuretics, hemodialysis
15784119|NCT04580316|Behavioral|Parental active presence|The parents were allowed to stand close to their children, do handholding, eye contacting and help in explaining the dentist's instructions.
15784120|NCT04580316|Behavioral|Parent passive presence|Parents were instructed to sit silently in the dental clinic behind the patient with no eye contact, and without a spoken word only to reassure their children
15784121|NCT04580303|Drug|EN3835|collagenase clostridium histolyticum (CCH)
15784122|NCT04580290|Device|JewelACL|The JewelACL is a polyester scaffold for anterior cruciate ligament (ACL) reconstruction
15784123|NCT04580277|Drug|Tofacitinib 10 mg|Subjects in this arm will receive tofactinib 10 mg twice daily for 8 weeks
15784124|NCT04580264|Behavioral|REINTERVENTION|This self-applied online program will take three months and comprise 9 behavioural modules developed gradually, achieving the changes needed on eating and physical activity habits, supported by audiovisual instructions given by an hypertension specialist doctor.
15784125|NCT04580251|Procedure|Targeted axillary dissection|The surgical treatment procedure of targeted axillary dissection performed in patients in whom the pathological lymph nodes have been marked using the examined and compared markers (magnetic marker Magseed, iodine seed 125I, carbon suspension)
15784126|NCT04580238|Drug|Botox 200 UNT Injection|"Treatment Protocol:
~Botox 200 IU vials for 40 patients for the duration of study (4 treatment cycles); Treatment will be based on the PREEMPT study full treatment (standard of care) and follow the pain protocol to a total of 195 IU in standard injection sites"
15784127|NCT04580238|Combination Product|Non Botox based Standard of Care Treatments for Headache/Migraine|Control Group will receive normal standard of care Non-Botox based interventions.
15784128|NCT04580225|Procedure|Four-Corner Arthrodesis|Participants in Group A will receive a four-corner arthrodesis (fusion of the capitate, hamate, lunate, and triquetrum) with excision of the scaphoid.
15784129|NCT04580225|Procedure|Three-Corner or Capitolunate Arthrodesis with Triquetral Excision|Participants in Group B will receive a three-corner arthrodesis (fusion of the capitate, hamate, and lunate) or capitolunate arthrodesis (fusion of the capitate and lunate) with excision of the scaphoid and triquetrum.
15784130|NCT04580212|Behavioral|Poultry hygiene intervention|The intervention will consist of a series of participatory training exercises designed to accomplish three main goals: (1) increase awareness of health risks and lost livelihood benefits of current poultry management practices, (2) build practical skills for poultry management, and (3) build supportive community norms by facilitating savings group discussions on poultry management. The intervention will be delivered through three activities: (1) triggering exercise designed to raise awareness of both the health risks of the current practices and the economic potential of a more active poultry management approach, and ultimately to motivate participants for behavior change, (2) poultry management training activity based on local needs and norms, and (3) periodic follow-on coaching to reinforce messages from the initial training and emphasize action planning, monitoring of plan execution, and troubleshooting.
15784131|NCT04580199|Procedure|thyroidectomy|to excise the thyroid gland
15784132|NCT04580186|Procedure|bladder exstrophy repair|primary complete bladder exstrophy repair
15784133|NCT04580173|Diagnostic Test|metabolomics analysis|Targeted and untargeted metabolomics-based analysis will be performed using Gas Chromatography tandem Mass Spectometry and Liquid Chromatography tandem Mass Spectrometry, in order to quantify serum biomarkers.
15784134|NCT04580160|Device|Duo Venous Stent System|Subjects with nonmalignant iliofemoral venous outflow obstruction presenting with nonthrombotic (NT), acute thrombotic (AT) or chronic postthrombotic (CPT) disease pathogenesis will be selected for study participation.
15784135|NCT04580147|Drug|Intravitreal aflibercept injection|Intravitreal aflibercept injection (2mg/0.05mL) at the conclusion of RRD repair surgery, at post-operative day 30 (+/-7 days), and at post-operative day 60 (+/-7 days)
15784136|NCT04580147|Other|Sham control|Sham procedure at post-operative day 30 (+/-7 days), and at post-operative day 60 (+/-7 days)
15784140|NCT04580121|Drug|RO7283420|RO7283420 at RP2D will be administered by IV infusion as per dosing schedule determined in Part B.
15784141|NCT04580121|Drug|Tocilizumab|Tocilizumab will be administered as an IV infusion 8 mg/kg (for participants with a weight of 30 kg and above) and 12 mg/kg (for participants with a weight of less than 30 kg). Tocilizumab will be given as rescue medication.
15784142|NCT04580121|Drug|Dasatinib|Dasatinib 100 mg film-coated tablets will be administered daily until symptom resolution (up to 100 mg twice daily [BID] for a maximum 3 days); orally. Dasatinib will be given as rescue medication.
15784143|NCT04580121|Drug|Dexamethasone|20 mg IV of dexamethasone will be administered as pre-medication at least 60 minutes prior to the all RO7283420 infusions during cycle 1.
15784144|NCT04580121|Drug|Paracetamol/acetaminophen|500 or 1000 mg of paracetamol/acetaminophen will be administered orally or by IV as pre-medication at least 30 minutes prior to each RO7283420 infusion.
15784145|NCT04580121|Drug|Diphenhydramine|25 mg or 50 mg of diphenhydramine will be administered orally or by IV as pre-medication at least 30 minutes prior to each RO7283420 infusion.
15784146|NCT04580095|Other|AI algorithm for apical foreshortening in echocardiography|The algorithm is based on artificial intelligence, giving the sonographer performing the echocardiographic exam real-time feedback on left ventricular apical foreshortening.The algorithm is developed using deep learning techniques by technologists at the Department of Circulation and Medical Imaging, NTNU.
15784147|NCT04580082|Behavioral|Mindfulness lessons|14 lessons on mindfulness, each lasting approximately 20 minutes.
15784148|NCT04580069|Procedure|Lymphatic drainage|The interventions follow the validated techniques normally used in international rehabilitation
15784149|NCT04580056|Procedure|Uterine fundus endometrial incision during hysteroscopy|Uterine fundus endometrial scratching during hysteroscopy by incision
15784150|NCT04580043|Behavioral|Habit Override Practice|"Computerized brain training to provide practice in overriding avoidance habits."
15784151|NCT04580043|Device|Transcranial Magnetic Stimulation|Non-invasive method for temporary, focal stimulation of brain areas. Delivered in a continuous Theta Burst Stimulation (TBS) pattern.
15784152|NCT04580043|Behavioral|Sham Training|Computer-based task practice in a non-active/inert task.
15784153|NCT04580043|Device|Sham Transcranial Magnetic Stimulation|Sham stimulation of non-brain areas. Delivered in a continuous Theta Burst Stimulation (TBS) pattern.
15784154|NCT04580004|Other|Med Optimization Arm|An evidence-based medication recommendation website that is provided to the patients.
15784155|NCT04579991|Other|Visnadin, ethyl ximeninate, coleus barbatus and millet in emulgel|Topical product, apply small amount on mucosal surface of vulva included clitoris once daily
15784156|NCT04579991|Other|Emulgel-only|Topical placebo product, apply small amount on mucosal surface of vulva included clitoris once daily
15784157|NCT04579965|Drug|medical treatment of isthmocele|comparison between different drugs
15784158|NCT04579952|Device|transcranial Direct Current Stimulation|The current stimulation will be applied using 35 squares cm wide sponge electrodes
15784159|NCT04579939|Diagnostic Test|Candy Glucose Tolerance Test|Participants will use a popular dextrose candy alternative to help assess glycemic response.
15784160|NCT04579926|Other|Pinpoint app|Tablet and smartphone app with pain assessment and communication education, and pain assessment tool.
15784161|NCT04579913|Other|Review of medical history, administration of questionnaires, uroflowmetry and PVR as measured by ultrasound|Administration of questionnaires to assess patient LUTS, quality of life, sexual behavior and erectile function, in addition to performing PVR and uroflow tests.
15784162|NCT04579900|Procedure|Endoscopy and duodenal biopsy and sampling|All volunteers will have endoscopy and duodenal biopsy and will have to provide stool samples
15784163|NCT04579887|Other|Brain changes triggered by PH induction in Parkinson's disease patients with presence hallucinations|Parkinsonian patients will undergo a two distinct experimental sessions, conducted in two separate days. In day 1, they will complete a series of validated and lab-tailored clinical evaluations, alongside with semi-structured interviews. These tests are designed to assess, the extent of the movement disorder, the predominance of positive symptoms and presence hallucination, potential cognitive impairment, amongst other relevant measures, for sleep assessment, loneliness, apathy and depression. In day 2 patients will perform the described robotic manipulation task in the MRI.
15784164|NCT04579874|Diagnostic Test|LIVERFASt|blood draw
15784165|NCT04579861|Other|Prospective data collection following gynaecological oncology surgery|Prospective data collection and entry on database following gynaecological oncology surgery
15784166|NCT04579848|Drug|Methotrexate Tablets|Methotrexate 2.5mg oral tablet.
15784167|NCT04579848|Drug|Placebo|Placebo capsule
15784168|NCT04579848|Drug|Folic Acid 1 MG|Folic acid
15784169|NCT04579835|Other|External Cephalic Version|External Cephalic Version Twin A
15784170|NCT04579822|Biological|influenza vaccine|quadrivalent influenza vaccination in the flu seasons
15784171|NCT04579809|Procedure|4 strand technique|4 strand technique reapir of tendin flexor injury
15784172|NCT04579796|Other|ultrasound exam|An abdominal ultrasound exam to assess the placenta implantation site.
15784173|NCT04579796|Procedure|hysteroscopy diagnostic|Diagnostic hysteroscopy to asses the placenta implantation site.
15784174|NCT04579783|Drug|Triamcinolone Acetonide|Group A: 40mg triamcinolone acetonide (1mL) + 4mL normal saline
15784175|NCT04579783|Drug|Dextrose 5% in water|Group B: 5mL 5% dextrose
15784176|NCT04579770|Dietary Supplement|Ketone ester|75g ketone ester in the form of a drink [96% (R)-3-hydroxybutyl (R)-3-hydroxybutyrate, Oxfordshire, UK)] will be provided.
15784177|NCT04579770|Other|Sodium bicarbonate|Sodium bicarbonate - widely accessible food ingredient will be provided.
15784178|NCT04579770|Other|Placebo|Placebo
15784181|NCT04579744|Other|EuroQol 5D questionnaire|EuroQol questionnaire (EQ-5d) facilitates to obtain values of health in the physical, psychological, and social dimensions. It is a standardized non-disease specific instrument to describe and value the health-related quality of life.
15784182|NCT04579731|Drug|Lactitol Monohydrate|Patients with lower urinary tract dysfunction and assumed to have constipation were placed on lactitol monohydrate 10 g for 8 weeks, and had re-evaluated.
15784183|NCT04579718|Other|Zeus Cloud TPS V1.0|Zeus Cloud TPS V1.0 is used to design the radiotherapy plan for the subjects and the plan is evaluated.
15784184|NCT04579718|Other|Eclipse|Eclipse TPS of Varian company is used to design the radiotherapy plan for the subjects and the plan is evaluated.
15784185|NCT04579705|Other|Using a brush|Surgical hand scrubbing will be performed in 1 minute and 2 minutes using a disposable nail brush.
15784186|NCT04579692|Device|ExAblate Transcranial treatment|Patients' head will be placed in ExAblate device to hold it still for the treatment. The ExAblate Transcranial helmet will be placed on their head. The investigators will measure the study participant's heart, blood pressure, temperature, and breathing rate before the treatment begins. MRI scans will be taken to make sure the ultrasound waves will be aimed exactly within the target. A series of MR images will be taken to identify the target area, and plan the study treatment. The study investigators will decide on the area of participant's brain that will be treated. The ExAblate Transcranial system will compute a plan to cover the treatment area. This area is gradually heated while monitoring the patient's responses and neurologic examination.
15784187|NCT04579679|Drug|Surufatinib|Surufatinib 300 mg oral once daily
15784190|NCT04579653|Device|transcutaneous electrical nerve stimulation devices|electrical stimulation through surface electrodes
15784191|NCT04579640|Dietary Supplement|Vitamin D|Capsules containing 800 IU (20 micrograms) or 3,200 IU (80 micrograms) cholecalciferol
15784192|NCT04579627|Behavioral|Questionnaire|A single survey questionnaire to staff to report their demographics and facial hair styles between January and April 2020
15784193|NCT04579614|Behavioral|The Impact of Performance Feedback and Variable Goal Setting on Flu Vaccination Success Rates of Providers|"A given provider will be involved in the study for a maximum of 6 months. This will involve, at the most frequent, the delivery of weekly performance feedback.
~The performance feedback will be delivered using standard approaches already in place in the organization and there will not be a period of seeking out participants for enrollment.
~Providers will receive performance feedback bi-weekly for the duration of the study period."
15784194|NCT04579601|Procedure|ERAS program|We designed our centre's ERAS program through different measures during the preoperative, intraoperative and postoperative period. This program incluided received comprehensive multidisciplinary information, daily goals and expected discharge date, explained the expansión exercises, the video-assisted thoracoscopic surgery (VATS) under general anaesthesia combined with regional techniques, leaving only one chest tube at the end of the surgery, maintain normothermia, extubation after the end of the surgery, and early removal of the urinary catheter. From the time of extubation, the patients began oral tolerance and respiratory physiotherapy exercises. Also, the patients were allowed to walk around early.
15784195|NCT04579588|Biological|Flu shot|All participants will receive a single shot of the flu vaccine
15784196|NCT04579575|Device|Trans-abdominal Ultrasound|"All patients will undergo trans- abdominal and trans-vaginal examination (The trans-abdominal US was performed for virgin patients or patients with large tumors that cannot be completely seen by the TV route) performed on the devices available in South Egypt Cancer Institute in supine position.
~The most important b-mode parameters (such as gain, frequency, number of foci and their depth, etc.) of the US machines were manually adjusted to obtain similar image impressions.
~The morphological features of each AM, and independently categorized the US images of each AM according to the O-RADS published by ACR and GI-RADS simple rules . The results of consensus reviewing were used to calculate the validity of each US classification system.
~The definite diagnoses of AM were preferentially established based on
~Histo-pathological findings and other modalities."
15784197|NCT04579562|Other|No intervention|This is observational, non-interventional study
15784198|NCT04579549|Device|Saliva Assay|saliva assay test for high concentrations of SARS-CoV-2
15784199|NCT04579536|Other|Light curable resin modified glass ionomer varnish|Light curing resin-modified glass ionomer varnish (ClinproTM XT Vanish, 3M ESPE, Dental Products, St. Paul, MN, USA) will be used to seal 84 first permanent molars at baseline, 3, 6, 12 and 18 months.
15784200|NCT04579536|Other|Vanish White Varnish|5% Sodium Fluoride (NaF) with Tri-Calcium Phosphate topical varnish (Vanish White Varnish, 3M ESPE, Dental Products, St. Paul, MN, USA) will be used on 84 first permanent molars at baseline, 3, 6, 12 and 18 months.
15784201|NCT04579523|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo HCT
15784202|NCT04579523|Biological|Astatine At 211 Anti-CD38 Monoclonal Antibody OKT10-B10|Given IV
15784203|NCT04579523|Drug|Cyclophosphamide|Given IV
15784204|NCT04579523|Drug|Fludarabine Phosphate|Given IV
15784205|NCT04579523|Radiation|Total-Body Irradiation|Undergo TBI
15784206|NCT04579510|Biological|Novel monovalent oral poliovirus vaccine type 2 (nOPV2)|nOPV2 candidate 1 (S2/cre5/S15domV/rec1/hifi3) is a live-attenuated serotype-2 poliovirus that was derived from a modified Sabin type-2 infectious cDNA clone and propagated in Vero cells. To improve genetic stability, nucleotide sequence modifications were made in the major determinant for attenuation in the Sabin 5'-untranslated region. Additionally, two modifications in the polymerase 3D were made to further improve stability of the attenuation, and a key replication element from the 2C coding region was relocated to the 5'-untranslated region to inhibit recombination.
15784207|NCT04579510|Biological|Bivalent oral poliovirus vaccine (bOPV)|The live types 1 & 3 oral polio vaccine (bOPV) is a bivalent vaccine containing suspension of types 1 & 3 attenuated Polio viruses (Sabin strains).
15784208|NCT04579497|Other|38°C warm water footbath|A ten-minute pre-intervention rest period followed by a 30-minute footbath with 16 l of warm water at a constant temperature of 38°C, followed by a ten-minute post-intervention rest period.
15784209|NCT04579497|Other|40°C warm water footbath|A ten-minute pre-intervention rest period followed by a 30-minute footbath with 16 l of warm water at a constant temperature of 40°C, followed by a ten-minute post-intervention rest period.
15784210|NCT04579497|Other|42°C warm water footbath|A ten-minute pre-intervention rest period followed by a 30-minute footbath with 16 l of warm water at a constant temperature of 42°C, followed by a ten-minute post-intervention rest period.
15784380|NCT04578054|Other|Flying transport|Patient care who requires flying transport
15784211|NCT04579497|Other|38-42°C rising temperature footbath|A ten-minute pre-intervention rest period followed by a 30-minute footbath with 16 l of warm water. Water temperature starts at 38°C and is increased by 1°C every 6 minutes, resulting in 42°C after 30 minutes. The footbath is followed by a ten-minute post-intervention rest period.
15784212|NCT04579471|Diagnostic Test|SARS-CoV-2 IgG|Collection of clinical variables, assessment of IgG antibodies for SARS-CoV-2, plasma collection for translational immunology studies
15784213|NCT04579458|Procedure|Collection of tears and saliva.|Saliva and ocular tears will be collected.
15784214|NCT04579445|Other|Education on tailored Quality Improvement measures|Centers will undergo an education on defined Quality of Care measures, with the aim to implement a standardized pathway which is reproducible, scalable and which will allow increased access. The implementation of these measures will help to reduce resource requirements, intensive care bed occupancy and overall length of hospital stay with uncompromised patient safety.
15784215|NCT04579432|Other|Education|With the training module prepared according to the ADDIE model, the intervention group will be trained on reproductive health and sexual health.
15784216|NCT04579419|Drug|Sodium Bicarbonate|Botulinum Toxin diluted in Sodium Bicarbonate
15784217|NCT04579419|Drug|Normal Saline|0.9 NaCl
15784218|NCT04579406|Procedure|non-cardiac surgery|All the patients are undergoing non-cardiac surgery.
15784219|NCT04579393|Drug|Placebo|Placebo tablets to match fostamatinib 100 mg and 150 mg will be provided.
15784220|NCT04579393|Drug|fostamatinib|The study intervention is fostamatinib, an inhibitor of spleen tyrosine kinase that will be administered orally at a dose of 150 mg twice daily for 14 days or 28 doses. Subjects will receive standard of care and be randomized to receive fostamatinib or matching placebo.
15784225|NCT04579354|Other|virtual reality tour|Patients will be guided via VR on their way through the hospital to the operating theater
15784226|NCT04579341|Dietary Supplement|probiotics|probiotics administration
15784227|NCT04579328|Behavioral|Exposure to Growth Mats|see arm/group descriptions for description of intervention
15784228|NCT04579315|Other|Intervention group; NNRD group|The intervention is a whole food approach, meaning that the participants in the intervention group receives all daily food elements that they should consume
15784229|NCT04579302|Procedure|Serratus anterior block (SAB)|Patients will receive a sonar guided serratus anterior plane block with 20 ml of bupivacaine 0.5%
15784230|NCT04579302|Procedure|Erector spinae block|Patients will receive a sonar-guided erector spinae plane block with 20 ml of bupivacaine 0.5%
15784231|NCT04579302|Drug|Saline (as a placebo)|Patients will receive a sham block with 20 ml saline (as a placebo)
15784232|NCT04579302|Drug|Bupivacaine|bupivacaine
15784233|NCT04579289|Other|questionnaire|"A questionnaire was e-mailed to all identified institutions, with 3 reminders in one month. It included 39 questions concerning :
~morbidity and mortality linked with COVID-19
~structural features of the facility (location, architecture, residents characteristics)
~human resources
~crisis management (visits and circulation restrictions, personal protective equipment)"
15784234|NCT04579276|Procedure|Thoracic paravertebral block|Intrathoracic method undergone through video assisted surgery (VATS
15784235|NCT04579276|Procedure|thoracic epidural analgesia|locoregional analgesia under ultrasound control
15784236|NCT04579263|Other|Fecal microbiota|Transplantation of fecal microbiota of healthy donor with normal body mass index
15784242|NCT04579211|Diagnostic Test|urine lipoarabinomannan (LAM)|Investigate the utility of urine LAM as a test to identify individuals at very low risk for having a sputum culture positive for NTM.
15784243|NCT04579198|Behavioral|Caregivers' Aid to Accelerate Recovery after pediatric Emergencies (CAARE)|The intervention, CAARE (Caregivers' Aid to Accelerate Recovery after pediatric Emergencies), consists of four components: First, all caregivers of PTI patients (ages 0-11) will be given brief education in the hospital related to children's and caregivers' emotional recovery. Second, all families will receive an in-hospital risk-reduction session. These sessions will address avoidance and trauma triggers; scheduling of pleasurable activities; and coping strategies. Third, all caregivers will receive the CAARE app-based components before discharge. The app will engage caregivers for 30 days via an automated SMS system. MHealth components of care will reinforce risk-reduction strategies. Fourth, 30 days post-discharge, a brief behavioral health screen will be completed by caregiver and child to assess need for more intensive screening by a mental health provider. Caregivers/children reporting elevated symptom levels will receive a comprehensive screening and referral process.
15784244|NCT04579185|Device|Transcranial Photobiomodulation|Transcranial Photobiomodulation--a noninvasive intervention in which near-infrared light (850 nanometer) is applied to forebrain.
15784245|NCT04579172|Procedure|Cervico- isthmic compression suture|Circular isthmic-cervical sutures will be applied . To avoid ureter and bladder injury, the bladder will be reflected downward. A silastic drain will be inserted into internal and through the external os , so as to drain the uterine cavity and to keep the cervical canal open. Firstly, at the left side of the uterus, a Vicryl number two (No..2) stitch will be inserted very close to the cervix from the anterior to the posterior side of the broad ligament.
15784747|NCT04575181|Drug|Insulin glargine|For s.c. injection once daily for 26 weeks
15784246|NCT04579172|Procedure|Anterior wall uterine resection:|After fetal delivery, two corners of the uterine incision and the superior and inferior lips will be clamped immediately by four Mayo clamps. Blunt dissection downward to the bladder-uterus peritoneal reflection will perform, to the partial anterior wall of the uterine myometrium where the placenta was deeply adherent (a myometrium defect, with only the serous layer of the uterus) will be respected, together with the placenta. It is important to ensure that sufficient myometrium above the peritoneal reflection will be available for an optimum closure. Then, as much remaining placenta as possible will be removed piecemeal from the edge of the uterine incision. Clamps and multiple hemostatic sutures will be applied rapidly
15784247|NCT04579159|Device|Preventicus heartbeat app in combination with wearables|CE certified devices
15784248|NCT04579146|Other|coronary computed tomographic angiographic (CCTA)|x-ray examination with contrast by a 64-slice CT coronary angiography.
15784249|NCT04579133|Drug|Olaparib|300 mg BID OR 200 mg BID (if glomerular filtration rate [GFR] 31 to 50 mL/min)
15784250|NCT04579133|Drug|Durvalumab|Durvalumab 1500 mg IV
15784251|NCT04579120|Drug|[11C]-Pittsburgh Compound B ([11C]PiB)|A dosage range between 6.0 - 20.0 mCi (222-740 MBq) is planned for [11C] PIB. A PET-certified medical professional will prepare and administer the [11C] PIB tracer. Prior to the administration, the dosage will be assayed in a dose calibrator and diluted with 0.9% sodium chloride (normal saline) up to a total 20 mL syringe volume. Participants will receive a maximum intravenous bolus injection of 20.0 mCi of [11C] PIB followed by a 10 mL 0.9% sodium chloride (normal saline) flush.
15784252|NCT04579120|Drug|F 18 AV-1451 (Flortaucipir)|A dosage range between 6.5 - 10.0 mCi (240-370MBq) is planned for [18F] AV-1451. A PET-certified medical professional will prepare and administer the [18F] AV-1451tracer. Prior to the administration, the dosage will be assayed in a dose calibrator. The volume of 18F-AV-1451 dose should not be adjusted by adding normal saline to the syringe. Participants will receive a maximum intravenous bolus injection of 10.0 mCi of [18F] AV-1451 followed by a 10 mL flush of 0.9% sodium chloride (normal saline).
15784253|NCT04579107|Combination Product|Contrast Enhanced Mammography|A modality for examining breast conditions which is already approved and used but the evaluation of its role in a recalled screening population is limited. Intravenous iodine contrast is given prior to the mammogram.
15784254|NCT04579094|Other|Feces sampling at inclusion (J0)|Feces sampling at inclusion (J0)
15784255|NCT04579081|Device|Contour Neurovascular System|Intrasaccular flow disruptor/divertor
15784256|NCT04579068|Behavioral|Screening and Brief Intervention of Problematic Alcohol Use|Provide/enhance knowledge, screening and detection, modify attitudes, motivate and provide skills and resources to reduce alcohol related risk and consumption.
15784257|NCT04579055|Other|1-min STS test: adjusted|Individually adjusted chair seat height of 90° knee joint flexion
15784258|NCT04579055|Other|1-min STS test: standardized|Standardized chair seat height of 46 cm
15784260|NCT04579029|Procedure|Lymphaticovenous anastomosis surgery combined with near infrared spectroscopy imaging|Lymphoedema is well recognized as a chronic debilitating disease resulting from an abnormal collection of protein-rich fluid within the subcutaneous tissues of the body. Given the need to identify more effective treatments, more recent advances in super microsurgical techniques have seen the introduction of new procedures, perhaps the most successful of which have involved re-routing the lymphatic fluid by using microsurgery to divert small lymphatic channels into venules in the sub-dermal plane (LVA surgery). This procedure is performed under regional or general anaesthetic as a day-case operation, leaving only a few very short scars in the skin of the arm or leg.
15784261|NCT04579016|Other|PAIGE2 lifestyle intervention|Education session during pregnancy. provision of fitness tracker, referral to commercial weight management organization, text and phone support
15784262|NCT04579016|Other|Standard care|Care routinely provided to all pregnant women diagnosed with GDM
15784263|NCT04579003|Other|Mobilization|"Moist hot pack for 10 mins/1 set/ 6 consecutive days, Ultrasound for 5 mins/1 set/ 6 consecutive days, TENS on shoulder region for 10 mins/1 set/ 6 consecutive days, Shoulder mobilization posterolateral glide for 30 secs with 30 secs rest for 5 mins.
~A total of 6 consecutive sessions were given each consisting of 30 mins."
15784264|NCT04579003|Other|Mobilization with movement|"Moist hot pack for 10 mins/1 set/ 6 consecutive days, Ultrasound for 5 mins/1 set/ 6 consecutive days, TENS on shoulder region for 10 mins/1 set/ 6 consecutive days, Shoulder mobilization with movement (MWM) 10 repetitions with 30 secs rest for 5 mins.
~A total of 6 consecutive sessions were given each consisting of 30 mins."
15784265|NCT04578990|Other|Walking intervention|"It will consist of performing the Treadmill training progression for 36-72 sessions. 3 sessions of 60 minutes, will be held weekly.
~Depending on the data obtained in Visit 1, the speed will be determined for each patient and the degree of the initial slope that is comfortable when walking until it induces symptoms of moderate intermittent claudication. The progression of the intensity of the speed and incline of the slope will be increased progressively and individually for each patient."
15784266|NCT04578990|Other|Strength intervention|The training program consists of performing a training program with resistance exercises for 36-72 weeks. There will be 3 weekly sessions of 60 minutes, where exercises with resistance will be applied. The same guidelines will be followed as in the walking exercise, but in this case, applying force stimuli. If symptoms of moderate intermittent claudication occur (3-4) based on the Claudication Symptom Rating Scale in 5-10 minutes, a period of rest (sitting or standing) will be performed until the pain disappears at the level of the lower limb. This sequence will be repeated until the strength training session is completed. The progression of force stimuli will be increased weekly depending on the subjective perception of the patient's effort and according to the guidelines set by our group of investigation.
15784297|NCT04578769|Procedure|full-thickness myotomy|"Initial mucosal incision. After submucosal injection, a reverse T entry incision is made at approximately 10 cm proximal to the gastroesophageal junction (GEJ).
~Submucosal tunnel establishment. A submucosal tunnel is created to 2-3 cm distal to the GEJ.
~Endoscopic myotomy. A selective circular muscle myotomy is carried out in a proximal to distal direction, from 2 cm distal to the mucosal entry down to 4 cm proximal to the GEJ, and a full-thickness muscle myotomy is continually carried out from 4cm proximal to the GEJ down to 2 cm distal to the GEJ.
~Zippered closure of mucosal entry. The mucosal incision is closed using hemostatic clips."
15784748|NCT04575181|Drug|Placebo (NNC0268-0965)|For s.c. injection once daily for 26 weeks
15784267|NCT04578990|Other|Concurrent intervention|The training program consists of alternating strength and resistance stimuli in the same session for 36-72 weeks. There will be 3 weekly sessions of 60 minutes, where exercises with resistance will be applied for 35 minutes and to complete the 60 minutes, the same guidelines will be followed as in the walking exercise, applying resistance stimuli. If claudication symptoms occur moderate intermittent (3-4) based on the Claudication Symptom Rating Scale in 5-10 minutes, a period of rest (sitting or standing) will be performed until the pain in the lower extremity disappears. This sequence will be repeated until the 20 minutes established to end the session are completed concurrent training. The progression of the strength and resistance stimuli will be increased weekly depending on the perception subjective effort of the patient and according to the guidelines established by our research group.
15784268|NCT04578977|Behavioral|Functional assessment of surgical treatment of terrible triade injury of the elbow|Functional assessment of surgical treatment of terrible triade injury of the elbow
15784269|NCT04578951|Device|FHK® total knee prosthesis|FHK® prosthesis are intended to be implanted in the tibial and femoral regions during total knee arthroplasty in order to restore joint function.
15784270|NCT04578938|Drug|Intravenous ketamine|Single subanesthetic infusion of ketamine (0.5mg/kg)
15784271|NCT04578938|Behavioral|Cognitive training|8 sessions of computer-based cognitive training
15784272|NCT04578938|Behavioral|Sham Training|8 sessions of computer-based sham training
15784273|NCT04578925|Behavioral|Happy, Healthy, Loved|A text message based, mobile-device delivered intervention that provides educational information to primiparous mothers and their partners about breast-feeding and coping with stress.
15784274|NCT04578912|Behavioral|Comprehensive Behavioral Intervention for Tics (CBIT)|CBIT is a manualized treatment program focused on tic management skills
15784275|NCT04578912|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|During repetitive transcranial magnetic stimulation (rTMS), a electromagnetic coil is placed against the scalp while an electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the target brain region
15784276|NCT04578912|Device|Continuous Theta Burst Stimulation (cTBS)|During continuous theta burst stimulation (cTBS), a electromagnetic coil is placed against the while an electromagnet painlessly delivers magnetic bursts that stimulate nerve cells in the target brain region
15784277|NCT04578899|Device|Transvertebral magnetic stimulation|Continuous theta-burst with a frequency of 5 Hz, lasting 20 minutes 3 times a week for 5 weeks, the total number of procedures is 15
15784278|NCT04578886|Drug|Guanfacine|Guanfacine 2 mg administered at 21:00 for up to 14 days or otherwise indicated by study protocol.
15784279|NCT04578886|Drug|Placebo|Placebo, administered at 2100 for up to 14 days or otherwise indicated by study protocol.
15784280|NCT04578873|Drug|QPX7831|capsule
15784281|NCT04578873|Drug|placebo comparator|oral matched placebo capsule
15784282|NCT04578860|Other|Music therapy with Music Care app|Listening to music with Music Care app, every day, for 20 minutes, sitting up or lying down, at bedtime, with a headset or earbuds.
15784283|NCT04578860|Other|Sound therapy with White Noise|Listening to white noise with an app, every day, for 20 minutes, sitting up or lying down, at bedtime, with a headset or earbuds.
15784284|NCT04578860|Other|Treatment as usual for sleep disorders|No intervention
15784285|NCT04578847|Drug|Imatinib|Initial dose - 400 mg daily. If on imatinib, the dose should be decreased to 300 mg daily on the first stage, to 200 mg daily - on the second stage.
15784286|NCT04578847|Drug|Nilotinib|Initial dose - 300 or 400 mg twice daily. If on nilotinib to 400mg daily on the first stage, to 200 mg daily - on the second stage.
15784287|NCT04578847|Drug|Dasatinib|Initial dose 100 or 140 mg daily. If on dasatinib then to 50 mg daily on the first stage, to 25 mg daily - on the second stage.
15784288|NCT04578847|Drug|Bosutinib|Initial dose 500 mg daily. If on bosutinib, the dose should be reduced to 300 mg daily on the first stage, to 200 mg daily on the second stage.
15784291|NCT04578821|Other|Educational intervention|Educational intervention
15784292|NCT04578808|Other|Unruptured intracranial aneurysms|UIA of bifurcation between 3 and 7 mm for whom a clinical and imaging follow-up without occlusion treatment was scheduled by local multidisciplinary staff will be included. Extensive clinical, biological and imaging data will be recorded during a 3 years follow-up (visits at 1 and 3 years after inclusion).
15784293|NCT04578795|Device|Single use flexible ureteroscopy (PUSEN-OLIMPUS)|single use flexible ureteroscopy
15784294|NCT04578782|Drug|OnabotulinumtoxinA|BOTOX contains onabotulinumtoxinA, an acetylcholine release inhibitor and a neuromuscular blocking agent available in the lyophilized form of purified clostridium botulinum toxin type A, suitable for injection, for intramuscular, intradetrusor, or intradermal use. The recommended dilution is 100 Units/2 mL, with a final concentration of 5 Units per 0.1 mL. The recommended dose for treating chronic migraine is 155 Units administered intramuscularly using a sterile 30-gauge, needle as 0.1 mL (5 Units) injections per each site.
15784295|NCT04578769|Procedure|conventional myotomy|"Initial mucosal incision. After submucosal injection, a reverse T entry incision is made at approximately 10 cm proximal to the gastroesophageal junction (GEJ).
~Submucosal tunnel establishment. A submucosal tunnel is created to 2-3 cm distal to the GEJ.
~Endoscopic myotomy. A selective circular muscle myotomy is carried out in a proximal to distal direction, from 2 cm distal to the mucosal entry down to 2 cm distal to the GEJ.
~Zippered closure of mucosal entry. The mucosal incision is closed using hemostatic clips."
15784296|NCT04578769|Procedure|short myotomy|"Initial mucosal incision. After submucosal injection, a reverse T entry incision is made at approximately 6 cm proximal to the gastroesophageal junction (GEJ).
~Submucosal tunnel establishment. A submucosal tunnel is created to 2-3 cm distal to the GEJ.
~Endoscopic myotomy. A selective circular muscle myotomy is carried out in a proximal to distal direction, from 2 cm distal to the mucosal entry down to 2 cm distal to the GEJ.
~Zippered closure of mucosal entry. The mucosal incision is closed using hemostatic clips."
15784355|NCT04578353|Device|The AquaPass System|The AquaPass device is a capsule that creates relatively homogenous temperature around the patients' lower body, while controlling and maintaining at a low percentage the relative humidity within the capsule thus enabling controlled environment that enhances sweat rate.
15784356|NCT04578327|Device|Prosthetic hand|Different types of conventional prosthetic limbs will be used by subjects.
15784298|NCT04578769|Procedure|tailored myotomy|"Initial mucosal incision. After submucosal injection, a reverse T entry incision is made at approximately 2 cm proximal to the spastic segment within the esophageal body, which is identified based on information gained from high-resolution manometry (HRM).
~Submucosal tunnel establishment. A submucosal tunnel is created to 2-3 cm distal to the GEJ.
~Endoscopic myotomy. A selective circular muscle myotomy is carried out in a proximal to distal direction, from 2 cm distal to the mucosal entry down to 2 cm distal to the GEJ.
~Zippered closure of mucosal entry. The mucosal incision is closed using hemostatic clips."
15784299|NCT04578756|Drug|Cariprazine Flexible Dose|1 capsule to be taken orally at approximately the same time of day (morning or evening)
15784300|NCT04578743|Device|Graded Exercise Therapy: ClearPlay(TM)|ClearPlayTM; a novel therapeutic intervention, downloadable to an Apple i-touch or i-phone device, that provides a telemetry-based graded exercise program that enables remote monitoring of symptoms.
15784301|NCT04578717|Procedure|Air-abrasion|A clinical air-abrasion unit was used to pre-condition the NCCLs with bioactive glass 45S5 powder for 10 sec. The operating parameters were; air pressure, 20 psi; powder particles size, 20 µm; nozzle angle, 90◦; nozzle-lesion distance, 5 mm and the internal nozzle diameter, 900 µm
15784302|NCT04578717|Procedure|Adhesive application - Etch&rinse|Enamel and dentine were etched using 37% Phosphoric acid for 30 sec and 15 sec respectively. NCCLs were rinsed thoroughly for 20 sec to remove the acid. Excess water was removed using a cotton pellet to leave a moist dentine surface. One coat of bonding adhesive was gently scrubbed on the entire enamel and dentin surface for 20 sec, air dried for 5 sec and light cured for 10 sec using LED curing light. The light intensity of curing unit was calibrated daily using curing radiometer .
15784303|NCT04578717|Biological|Adhesive application - Self-etch|The bonding adhesive was applied to enamel and dentine for 20 sec with agitation, gently air dried and light cured for 10 sec.
15784304|NCT04578704|Other|Vacuum formed retainer, fixed bonded retainer, vacuum formed and fixed bonded retainer|"Patients will be instructed to wear the removable vacuum form retainer for 8 to 10 hours per day and only removed the retainers during tooth brushing. (Thickett 2010), (Gill 2007).
~The vacuum formed retainer will be constructed using thermoplastic material that will be purchased from manufacturer at 1.0mm thickness.
~Meanwhile, bonded retainer will be done using Ormco ® response deadsoft retainer wire size 0.190 round, made in USA by ORMCO Corporation, the fixed bonded wire will be extended distal to the extraction spaces that were previously closed by fixed appliances on both the upper and lower arches. The bonded retainer will be wearing by patients for 24 hours.
~Double regime retainer that will be comprised of vacuum formed and bonded retainer will be constructed using the same properties as vacuum formed retainer and bonded retainer. A standard oral and written instruction will be given to patients regarding retainer's uses. (Shawesh M et.al, 2009)."
15784305|NCT04578691|Device|"Anatase Spine Surgery Navigation System"|using navigation system in pedicle screw placement in spine surgery
15784306|NCT04578691|Device|Medtronic Stealthstation S7 Treatment Guidance System|using navigation system in pedicle screw placement in spine surgery
15784307|NCT04578678|Other|Steering|Fine tuning of the STN-DBS settings
15784308|NCT04578665|Behavioral|Behavioral Interaction Conditions|The participants will be single-blinded and complete a tracking task as either: solo task, collaboration task (both participants work on a common task synchronously to achieve a goal; this is a summative effort to achieve the goal), competition task (each participant has to achieve a goal at the expense of his or her partner, therefore maximizing effort or error of the partner in reaching the goal), or cooperation task (an asymmetric partnership with an active partner and a passive partner working towards a goal).
15784309|NCT04578665|Device|Haptic Impedance Level|The subjects will complete their task at 3 impedance levels: high (a virtual stiffness 160-200 N/m and damping 0~10 Nm/s; this will be a stiff connection in which the subjects feel like they are connected via rigid links and each subject will perceive the other partner's movement directly), medium (a virtual stiffness 100-140 N/m and damping 0~10 Nm/s; this will be a spring like-connection in which the subjects feel like they are connected with a spring and each subject will perceive the other partner with a force that is proportional to the trajectory difference of the two participants), and soft (a virtual stiffness 40-80 N/m and damping 0~10 Nm/s; this will be a spring like connection in which the subjects feel like they are connected with a loose spring and each subject will perceive the other partner with a force that is proportional to the trajectory difference of the two subjects, however, this force will be smaller than that of the medium impedance).
15784310|NCT04578665|Behavioral|Skill Level of Partner|There will be two skill levels: novice (a participant who has no prior experience with the trajectory tracking experiment; in testing with the clinical populations, the investigators will assign this condition to the clinical participant) and expert (a participant who is experienced with the trajectory tracking experiment and who can achieve a tracking error [difference of the desired trajectory and actual trajectory] below a certain threshold; in testing with the clinical population, the investigators will assign this condition to the therapist). Participants will start experimentation paired as novice-novice, and at the end of the session may be invited to continue additional sessions to be paired as the expert in a novice-expert dyad.
15784311|NCT04578665|Device|Robot Controller Showcase|The subjects will complete 10 training sessions per assistive robot for the researchers to observe motor learning and functional outcomes.
15784312|NCT04578652|Drug|Metformin 850 mg oral tablet bid|MET dose: 500 mg daily, increasing to 500 bid if tolerated after 2 weeks, then increasing again 2 weeks later to 850 mg bid (1700 mg daily).
15784313|NCT04578652|Dietary Supplement|Supplemental fiber mixture (35 g total) composed of 6g of Oligofructose + 12g of resistant maltodextrin + 12g of acacia gum + 5g of PGX.|The first week of treatment will use 1/3 the daily treatment dose; then 2/3 dose for the second and third weeks; then the full dose thereafter, to allow time for adaptation.
15784314|NCT04578639|Drug|Rituximab|A prospective randomized double blinded multicenter non-inferiority study designed to establish non-inferiority of the study treatment rituximab compared with the comparator ocrelizumab for consecutively included patients (male or female) with active relapsing-remitting multiple sclerosis aged 18-60 years. Active substance is biosimilar rituximab iv infusion and comparator is ocrelizumab (Ocrevus ®) iv infusion. Both treatments are given as infusion at month 0, month 6, month 12, month 18 and month 24. Randomization rituximab: ocrelizumab is 2:1. The primary end-point is proportion of patients with no new or enlarging T2-weighted brain MRI lesions between re-baselining at month 6 and month 24.
15784749|NCT04575181|Drug|Placebo (insulin glargine)|For s.c. injection once daily for 26 weeks
15784315|NCT04578639|Drug|Ocrelizumab|A prospective randomized double blinded multicenter non-inferiority study designed to establish non-inferiority of the study treatment rituximab compared with the comparator ocrelizumab for consecutively included patients (male or female) with active relapsing-remitting multiple sclerosis aged 18-60 years. Active substance is biosimilar rituximab iv infusion and comparator is ocrelizumab (Ocrevus ®) iv infusion. Both treatments are given as infusion at month 0, month 6, month 12, month 18 and month 24. Randomization rituximab: ocrelizumab is 2:1. The primary end-point is proportion of patients with no new or enlarging T2-weighted brain MRI lesions between re-baselining at month 6 and month 24.
15784316|NCT04578626|Device|dry needling|The use of filiform needles to stimulate muscles and connective tissues. The needle is inserted in a direction perpendicular to the skin, a local twitch response is looked for and, once found, the needle is kept in the muscle without moving for 10 seconds. No substances are injected.
15784317|NCT04578613|Drug|ICP-022|ICP-022 at a dose of 150mg, QD
15784318|NCT04578613|Drug|Chlorambucil|0.5 mg/kg body weight orally on Day 1 and Day 15 of Cycles 1-6
15784319|NCT04578613|Drug|Rituximab|375 mg/m2 IV infusion on Day 1 of Cycle 1. 500 mg/m2 IV infusion on Day 1 for each of subsequent cycles (Cycles 2-6)
15784320|NCT04578600|Drug|Lenalidomide|Given PO
15784321|NCT04578600|Biological|Obinutuzumab|Given IV
15784322|NCT04578600|Drug|Oral Azacitidine|Given PO
15784323|NCT04578587|Device|MicroFET 2|Lumbar Flexor and Extensor Strength Measurement
15784324|NCT04578574|Other|Bodily Illusions (BI) Procedure|Each sessions will consists of two types of illusions that are 15 min each, the rubber hand illusion (RHI) and the walking illusion (WI) that involve both arms and legs.
15784325|NCT04578574|Device|Transcranial direct electrical stimulation (tDCS)|Each sessions will consists of electrical current delivered from a battery-driven, constant current stimulator using saline-soaked surface sponge electrodes. One electrode will be placed on your scalp on the right side and the other electrode over the left eye on your forehead. A weak current will be applied for 30 min at the same time as the BI.
15784326|NCT04578574|Other|Sham Transcranial Direct Electrical Stimulation (tDCS)|Each session of the Sham tDCS will be applied for 30 min at the same time as the BI.
15784327|NCT04578561|Procedure|Prophylactic mesh use|After laparotomy sutured clousur the abdominal wall wound is reinforced using a suprafascial synthetic mesh.
15784328|NCT04578548|Drug|GLPG2737|Capsules administered orally with food
15784329|NCT04578548|Drug|Placebo|Matching placebo capsules administered orally with food
15784330|NCT04578535|Drug|HYQVIA|Participants will receive subcutaneous infusion of HYQVIA either from a partial TDL dose to a full TDL dose with a ramp-up dosing scheme, or directly at the full TDL dose without ramp-up.
15784331|NCT04578509|Diagnostic Test|Nasopharyngeal swab|Research of SARS-CoV-2 infection in nasopharyngeal swab by RT-PCR and by antigenic test
15784332|NCT04578509|Diagnostic Test|Saliva sample|Research of SARS-CoV-2 infection in saliva samples by RT-PCR and by new detection approach
15784333|NCT04578509|Diagnostic Test|axillary sweat sample|Research of volatile olfactory compounds of SARS-CoV-2 infection by canine detection on axillary sweat.
15784334|NCT04578509|Other|Data collection|Demographics, symptoms, medical history, acceptability of specimen, consumption in precedents hours are collected
15784335|NCT04578496|Drug|Afamelanotide|
15784336|NCT04578483|Other|PCA group|Patients receiving PCA are allocated in PCA group despite the route of administration. Intravenous PCA is commonly used with morphine or fentanyl while epidural PCA is used with ropivacaine and/or fentanyl frequently.
15784337|NCT04578483|Other|ERDS group|After anesthesia, extended-release dinalbuphine sebacate (ERDS) is injected into gluteus maximus with ultrasound guidance.
15784338|NCT04578470|Drug|Vitamin D|Daily 2000 IU cholecalciferol(two tablets) for 13 weeks,and daily 1000 IUcholecalciferol(1 tablet) foranother 13 weeks.
15784339|NCT04578470|Drug|Placebo|two tablets daily for 13weeks then 1 tablet daily for13 weeks
15784340|NCT04578457|Device|Hearing Aid without NR enabled|Each participant will be fitted with noise reduction disabled. Disabled means that no sound processing algorithm that removes noise from the speech signal is active.
15784341|NCT04578457|Device|Hearing Aid with NR(1)|Each participant will be fitted with the noise reduction program on the same hearing aid. The principle of the noise reduction algorithm is to remove noise from a speech signal with the aim of improving the speech intelligibility and comfort.
15784342|NCT04578457|Device|Hearing Aid with NR(2)|Each participant will be fitted with a second noise reduction program on the same hearing aid. The parameterization of this NR algorithm differs from that in NR(1).
15784343|NCT04578457|Device|Hearing Aid with NR(3)|Each participant will be fitted with a third noise reduction program on the same hearing aid. The parameterization of this NR algorithm differs from that in NR(1) and NR(2).
15784344|NCT04578444|Drug|Zanidatamab|Administered intravenously
15784345|NCT04578431|Dietary Supplement|Artificial sweeteners (acesulfame-potassium, sucralose, saccharine, cyclamate)|The intervention is found in light products ingested by millions of people on a daily basis worldwide
15784346|NCT04578418|Dietary Supplement|Hydrolyzed collagen|Hydrolyzed collagen supplementation twice daily
15784347|NCT04578418|Other|Heavy slow resistance training|Heavy slow resistance training 3 times weekly
15784348|NCT04578418|Dietary Supplement|Placebo|Placebo supplementation twice daily
15784349|NCT04578405|Procedure|Intracorporeal anastomosis|Anastomosis performed totally laparoscopically
15784350|NCT04578405|Procedure|Extracorporeal anastomosis|Anastomosis performed through a minilaparotomy
15784351|NCT04578392|Procedure|high ligation of ileocolic artery|Patients will be randomized according to post-operative recurrence risk to surgery to high ligation or mesenteric sparing
15784352|NCT04578392|Procedure|mesenteric sparing|Patients will be randomized according to post-operative recurrence risk to surgery to high ligation or mesenteric sparing
15784353|NCT04578366|Device|Extracorporeal Shockwave Therapy|ESWT along with conventional therapy ESWT + hot pack(10min), ultrasound (5min), mobilizations, stretching, pendulum exercises, isometrics of shoulder
15784354|NCT04578366|Other|Conventional Treatment|hot pack(10min), ultrasound (5min), mobilizations, stretching, pendulum exercises, isometrics of shoulder
15784357|NCT04578327|Procedure|Peripheral Nerve Interface|Different types of peripheral nerve stimulation will take place
15784358|NCT04578314|Behavioral|Relating Therapy|Relating Therapy (RT) is a symptom-specific behaviourally oriented intervention that targets interpersonal relating as a key mechanism associated with auditory hallucination distress. The aim is that patients learn to relate more assertively within the difficult relationships they have with both the auditory hallucinations and other people. The RT will follow a treatment manual consisting of three phases: 1. Socialization to relating therapy and its implications; 2. Exploration of themes within the relational history of the participant and their experience of relationships with AH, and interpersonal relating within the family and social environment (identifying any prominent themes, such as abuse, disempowerment, or rivalry); 3. Exploration and development of assertive approaches to relating to AH and other people.
15784359|NCT04578314|Other|Treatment as usual|TAU will include medication management, supportive brief counselling sessions and various types of psychosocial (e.g. social work guided support, peer support) and monitoring provided by Mental Health Services, with individual and family psychological therapies offered occasionally. Individual therapies may include CBT or psychodynamic interventions. To amend for the heterogeneity of TAU across centres, the type and extent of any treatment received will be protocolled at T1 and T2.
15784360|NCT04578301|Other|No Intervention|No Intervention
15784361|NCT04578288|Procedure|INDIVIDUALIZED BLOOD PRESSURE MANAGEMENT DURING ENDOVASCULAR TREATMENT OF ACUTE ISCHEMIC STROKE UNDER PROCEDURAL SEDATION|The individual target range is defined as: bSBP ± 10 mmHg. The lowest possible SBP target range is 100-120 mmHg. The highest SBP target range is determined on the basis of whether patients receive concurrent IV fibrinolytic therapy or not. In patients where IV fibrinolytic therapy is applied, the highest SBP range is 160-180 mmHg, in patients without concurrent fibrinolytic therapy the highest SBP range is 180-200 mmHg.
15784362|NCT04578275|Other|diagnostic strategy using ECGI|"Procedure: Drug treatment, CVE, Pulmonary vein ablation isolation according to treatment guidelines and investigators discretion.
~ECGI: customized body surface mapping (57 electrodes) at the inclusion in the study, after treatment assignment and prior to AF ablation procedure."
15784363|NCT04578262|Procedure|Epley Manoeuvre|This manoeuvre is constituted by five steps. In the first step, while the patient is in supine posture the head will be positioned 45 degrees turned towards the unaffected ear and the head slightly overhang on the edge of the couch. In this second step maintaining the previous position of the head, physiotherapist will turn head 45 degrees turned towards the affected ear. Next, in the third step, the whole body will turn until is located 135 degrees from the baseline supine position. In the fourth step, while the head keeps turned to the affected ear the subject will be incorporated until he is sitting. In the fifth step, while the subject is seated with the head in neutral position the chin will be bended 20 degrees. Each procedure will be held among 30 seconds or two minutes, while the dizziness or the nystagmus vanish. The intervention will be conducted at the Physical Therapy Department of the University of Sevilla (Spain).
15784364|NCT04578262|Procedure|Sham Manoeuvre|The sham manoeuvre consist is going to star with the participant in a neutral seated position. Sum to it, head is rotated 45 degrees towards the unaffected vestibule. After that, the participant will be guided by the physiotherapist to a lateral decubitus position towards the affected side on which his nose will be pointing above. To conclude, the seated position will be reached again without head rotation. Each position of the sham manoeuvre will be maintained along one minute. During all the process the videonystagmography glasses will be dressed by participants and they will be indicated not to close eyes in the intervention. After the execution of the manoeuvre, also this group will be evaluated 48 hours after. The intervention will be conducted at the Physical Therapy Department of the University of Sevilla (Spain).
15784365|NCT04578249|Other|Blue light-blocking goggles|Participants will be randomly assigned to one of the two intervention groups.
15784366|NCT04578249|Other|Clear goggles|Participants will be randomly assigned to one of the two intervention groups.
15784367|NCT04578236|Combination Product|Aerosolized 13 cis retinoic acid plus Inhalation administration by nebulization captopril 25mg|Infected patients will receive aerosolized 13 cis retinoic acid in gradual one dose per day increases from 0.2 mg/kg/day to 4 mg/kg/day as inhaled 13 cis retinoic acid therapy for 14 days plus Inhalation administration by nebulization captopril 25mg for 14 days
15784368|NCT04578236|Drug|Drug: Standard treatment Standard treatment|Drug: Standard treatment Standard treatment is according to the protocol of treatment of 2019-nCoV infection
15784369|NCT04578210|Biological|T memory cells and NK cells|Single infusion of NK or memory T cells from a healthy donor recovered from COVID-19 (dose escalation).
15784370|NCT04578184|Diagnostic Test|Corneal epithelial thickness measurements|Corneal epithelial thickness measurements using two optical coherence tomography devices in healthy and keratoconus corneas.
15784371|NCT04578171|Drug|Mepolizumab|100 mg subcutaneous injections every four weeks
15784372|NCT04578158|Drug|Standard COVID-19 care|Patients will receive standard covid-19 care as per the hospital/physician guidelines
15784373|NCT04578158|Dietary Supplement|Quercetin Phytosome|Patients will receive a daily dose of 400 mg of oral Quercetin Phytosome
15784374|NCT04578145|Diagnostic Test|HIV self-testing among female sex workers|"Barriers faced by FSWs in terms of undergoing HIV blood test seemingly overcome through the implementation of alternative strategy of testing, by using OFT self-testing (Ora-Quick).
~Ora-Quick test used in this study measures antibody in oral fluid of participants. The oral fluid is collected used a test swab from participant's gum by wiping upper and lower gums once. The specimen mixed with buffered developer solution in test tube. Test result will appear in a short time, by 20 to 40 minutes and leading to interpret."
15784375|NCT04578119|Procedure|Sliding Intubating Technique|Sliding technique' means that endotracheal intubation is performed by sliding the videolayngoscope blade under the epiglottis smoothly.
15784376|NCT04578106|Biological|Trastuzumab and pertuzumab Subcutaneous Fixed-Dose Combination|After 13 weeks of neoadjuvant treatment, a breast MRI will be performed. If a complete response is observed on breast MRI, patients will undergo a stereotactic-guided VAB of the marker area to obtain 12 cylinders of breast parenchyma, which is equivalent to 2 grams of tissue. If no invasive tumor cells and no in situ disease are identified in the stereotactic-guided VAB, patients will be eligible to omit loco-regional surgery.
15784378|NCT04578080|Device|Transcranial direct current stimulation|Anodal/Cathodal/Sham tDCS will be applied in 1.5 mA, 20 mins before conventional physical therapy for 5 days. All experiments will be performed in random order for each subject.
15784381|NCT04578041|Device|TRPMS (Transcranial Rotating Permanent Magnet Stimulation)|"TRPMS ( is administered through a head cap worn by the participant and controlled by QHTimeStimulate application via computer tablet.
~Modality: Excitatory stimulation
~Frequency: 5 Hz
~Interval between stimulus: 100 ms
~Duration of each stimulus: 25 ms
~Duration of stimulation: 40 minutes
~Position of microstimulators: over primary motor cortex and supplementary motor area for Arm 1; over left and right dorsolateral prefrontal cortex for Arm 2"
15784382|NCT04578041|Other|Aerobic Exercise Program|Aerobic exercise consisting of 40 minutes of cycling training with a seated elliptical machine. The daily physical activity program will consist of three 10-minute bouts of aerobic exercise interspersed with two 5-minute bouts of rest. The participants will exercise maintaining their Heart Rate (HR) at least between 60-80% of the maximum age-related HR.
15784383|NCT04578041|Other|Computerized CT (Cognitive Training)|"Computerized cognitive training (CT) consisting of 40 minutes Brain-HQ training.
~The adaptive cognitive training games also serve to engage them during the stimulation session, and to keep them seated at the computer for the entire duration of the session."
15784384|NCT04578028|Drug|ONO-2808|Investigational drug
15784385|NCT04578028|Drug|Placebo|Placebo drug
15784386|NCT04578015|Drug|Metronidazole|Participants in this arm will receive metronidazole 500 mg twice daily, orally for 7 days
15784387|NCT04578015|Drug|Placebo|Participants in this arm will receive placebo
15784388|NCT04578002|Other|prehospital telemedical triage|Prehospital Triage of Patients with Suspected Stroke Using Onsite Mobile Telemedicine approach (interactive video and audio streaming). In patients with suspected stroke, a prehospital patient evaluation by end-to-end encrypted real-time audio- and video streaming from the pre-hospital setting to an in-hospital stroke physician, located at the University hospital of Basel, is requested and initiated (telestroke-path). The process is supervised and evaluated by an in-hospital stroke physician in real-time. Patients considered having an acute stroke will be directly transferred to cerebral imaging via CT.
15784389|NCT04577989|Other|data collection|data collection for treatment strategies (cefepime vs. piperacillin/tazobactam vs. carbapenems) of infections caused by AmpC beta-lactamase producing Enterobacterales for the period January 1st , 2015 until July 31st , 2020.
15784390|NCT04577976|Device|SMBG|Subjects and/or their caregivers will utilize capillary SMBG for managing diabetes for 6 months.
15784391|NCT04577963|Drug|Fruquintinib|Oral VEGFR inhibitor
15784392|NCT04577963|Drug|Tislelizumab|PD-1 inhibitor
15784393|NCT04577950|Procedure|Lymphatic drainage of endometrial cancer|Nanocoll® is injected a day before surgery in the cervix at four points. A lymphoscintigraphy is performed 2 or 3 hours afterward. At the beginning of the surgery, the operative field already in place and before the beginning of laparoscopic, 2ml (10mg) of ICG, distributed in four points around the tumor, is injected under the endometrium intra-myometrial under endoscopic control. As ICG spreads slower than blue dye, ICG is always injected first. Then, Bleu Patenté® is injected at two sites in the uterine isthmus, opposite of the uterine arteries. The risk of false negative results, because a tracer migrated too quickly, is reduced when the injection takes place when patients are already anesthetized.
15784394|NCT04577937|Diagnostic Test|LAM patients underwent PSG|Patients with confirmed diagnosis of LAM underwent a whole-night polysomnography. The presence of either acute or chronic respiratory failure or the use of long-term oxygen therapy are considered exclusion criteria
15784395|NCT04577924|Other|Interview|"Trained research assistants would abstract the data as per a preset proforma. The data would be collected from the patient (if coherent), pre-hospital care provider or primary care provider.
~Data would was also obtained from patient records and the proforma filled by the attending doctors on duty.
~Follow up of cases would be done until discharge from the hospital."
15784396|NCT04577911|Other|Basic Science Experiment|participants complete cognitive tasks while undergoing functional magnetic resonance imaging (fMRI)
15784397|NCT04577885|Drug|SHR2554 and Rifampin|Single-dose oral administration of SHR2554 and multiple-dose oral administration of Rifampin Capsules
15784398|NCT04577872|Other|Pelvic floor muscle training|The treatment for the sitting group comprised 8 sessions, with a 1-hour combined pelvic floor muscle training (cPFM-T) session each week in a group and 15 minutes of individual home training, six times a week for a total of 8 weeks of treatment. All training sessions comprised warming-up, gradual muscle strengthening and relaxation exercises. In the study, before and after the training programme, we used a self-administered questionnaire.We measured changes in pelvic floor muscle activity with a vaginal surface electromyographic instrument. We performed the transversus abdominis measurements at the same time as the vaginal measurements and pelvic floor muscle tasks.
15784399|NCT04577859|Device|ensoETM. Esophageal cooling during AF ablation|Esophageal cooling during AF ablation: The ensoETM probe is inserted via the orogastric route when the patient is under general anaesthesia. The device is set to cool during ablation of the posterior aspect of the left atrium, to protect against transmitted thermal energy and so reduce or prevent esophageal thermal injury.
15784400|NCT04577859|Device|Esophageal temperature monitoring probe|An esophageal temperature monitoring probe is normally used in standard of care AF ablations. This allows any temperature rise in the esophagus to be detected during ablation. If the temperature reaches >38 degrees then it is widely recognised that ablation should be halted until the temperatures fall back to below 38 degrees. It therefore has the ability to detect esophageal temperature rise only.
15784401|NCT04577846|Drug|Cephalexin 500 MG|Cefalexin 500 mg PO q8 hours will be continued for the duration of the indwelling drains which usually is about 14 days.
15784402|NCT04577846|Drug|Placebo|A placebo capsule filled with inert material for the duration of the drains which usually is about 14 days.
15784403|NCT04577833|Drug|Niraparib|Niraparib will be administered orally.
15784404|NCT04577833|Drug|Abiraterone Acetate (AA)|Abiraterone Acetate will be administered orally.
15784405|NCT04577833|Drug|Prednisone|Prednisone will be administered orally.
15784406|NCT04577820|Drug|garetosmab|Repeated doses administered intravenously (IV) every four weeks (Q4W)
15784407|NCT04577807|Biological|PVSRIPO|PVSRIPO administered via direct lesion injection
15784408|NCT04577807|Biological|Anti-PD-1 Checkpoint Inhibitor|Anti-PD-1 Checkpoint Inhibitor administered per package insert instructions
15784409|NCT04577794|Drug|GLPG3970|GLPG3970 powder and solvent for oral solution to be reconstituted prior to use.
15784410|NCT04577794|Drug|Placebo|Placebo powder and solvent for oral solution to be reconstituted prior to use.
15784411|NCT04577781|Drug|GLPG3970|GLPG3970 powder and solvent for oral solution to be reconstituted prior to use.
15784412|NCT04577781|Drug|Placebo|Placebo powder and solvent for oral solution to be reconstituted prior to use.
15784413|NCT04577768|Device|HD-tDCS 2 mA|anodal high definition transcranial direct current stimulation of the right primary motor cortex with an intensity of 2 mA
15784414|NCT04577768|Device|HD-tDCS 1.5 mA|anodal high definition transcranial direct current stimulation of the right primary motor cortex with an intensity of 1.5 mA
15784415|NCT04577768|Device|HD-tDCS sham|sham stimulation of the right primary motor cortex
15784416|NCT04577755|Drug|Pomalidomide|Given PO
15784417|NCT04577742|Radiation|106 Ruthenium plaque brachytherapy|All patients, affected by uveal melanoma, were treated with 106 Ruthenium plaque brachytherapy to a total dose of 100 Gy to the tumor apex. The time of implant duration was calculated according to the conventional central-axis-point dose calculation
15784418|NCT04577729|Procedure|Allogenic Fecal Microbiota Transplantation|Patients receiving stool from prior malignant melanoma (MM) patients in remission for at least 1 year after Checkpoint Inhibitor Treatment.
15784419|NCT04577729|Procedure|Autologous Fecal Microbiota Transplantation|Patients receiving their own stool in terms of sham FMT.
15784420|NCT04577716|Diagnostic Test|18F Sodium Fluoride Positron Emission Tomography / Computed Tomography|PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan
15784421|NCT04577716|Diagnostic Test|CT Aortic Angiogram|CT scan to assess aortic morphology and contextualise PET scan
15784422|NCT04577716|Diagnostic Test|12-month CT Aortic Angiogram|CT scan to assess aortic morphology and the stent graft
15784423|NCT04577716|Other|24-month review|This will consist of a telephone consultation with the study participant and review of electronic clinical records
15784424|NCT04577703|Drug|CT053PTSA|CT053PTSA will be administered daily in fasting state
15784425|NCT04577690|Drug|Bupivacaine 0.25% with epinephrine 1:200000 by PECS block and wound infiltration|The anesthesiologist will administer bupivacaine 0.25% with epinephrine 1:200000 by PECS block after induction of anesthesia before surgical incision. The EP cardiologist will also administer bupivacaine 0.25% with epinephrine 1:200000 by infiltrating the wound after surgery is complete.
15784426|NCT04577690|Drug|Bupivacaine 0.25% with epinephrine 1:200000 by wound infiltration only|The EP cardiologist will administer Bupivacaine 0.25% with epinephrine 1:200000 by infiltrating the wound after surgery is complete.
15784427|NCT04577677|Device|brain stimulation|tDCS and peripheral nerve stimulation
15784428|NCT04577664|Procedure|total thyroidectomy|a total thyroidectomy (TT) in which the entire gland is removed
15784429|NCT04577664|Procedure|subtotal thyroidectomy|subtotal thyroidectomy (STT) , in which most of the gland is removed leaving a small unilateral or bilateral remnant in situ about 4-5 grams.
15784430|NCT04577651|Device|16-contact Directional Deep Brain Stimulation|Deep Brain Stimulation with 16-contact Directional Lead
15784431|NCT04577638|Combination Product|Nivolumab and Intensity Modulated Radiotherapy (IMRT)|"Every included patient will receive the experimental treatment regimen as follows:
~Combination of IMRT 66 Gray (Gy)/24 fractions of 2.75 Gy) and immunotherapy with 3 doses of nivolumab, 240 mg (1th, 3th and 5th week of IMRT) during 5 weeks
~Maintenance treatment by nivolumab 240 mg (Q2W) during 6 months, or until progression and severe toxicity leading to definitive treatment interruption."
15784432|NCT04577625|Dietary Supplement|Lactobacillus reuteri (L. reuteri)|L.reuteri high or low dose with vitamin D3 compared to vitamin D3 only
15784433|NCT04577612|Drug|CHI-554|hemp-derived CBD in MCT oil
15784434|NCT04577599|Other|Mobile Low-dose Computed Tomography (LDCT) Screening|Low Dose CT Scan of the Chest
15784435|NCT04577586|Other|oral contrast|negative oral contrast utilization in PET/CT studies
15784436|NCT04577573|Device|Cognition glove|The investigators have developed and tested a functional prototype of an instrumented glove to alert the user about secure grasp of objects. Onboard force and flex sensors provide inputs to a machine learning algorithm (artificial neural network, ANN) to estimate secure grasp based on previously collected training data. The glove enhances agency by alerting the user to secure grasp through sensory feedback modules (visual - LED, audio - beeper, tactile - vibrator).
15784437|NCT04577573|Device|Sensory brace|"A a size- and position-adjustable arm brace with weight-support capability and housing for vibration motors and EMG sensors. Position adjustment allows for physical therapists to find and recommend arm postures that are clinically relevant to
~each person. The participant can then isometrically push/resist against the brace to strengthen target muscles while performing VR reach-to-touch. The person will receive visual feedback from the virtual environment to train movement performance and vibrotactile feedback at tendons to subconsciously adjust their muscle activation patterns"
15784438|NCT04577560|Genetic|First polar body biopsy in MII oocytes|Since PBs are by-products of the meiotic division of the oocyte and are not required for fertilization and subsequent embryo development, they can be removed to assess exclusively maternal chromosomal information without harming the embryo integrity. As previously described, PB biopsy does not impact the morphokinetic parameters of the embryo development and can be safely applied without the risk of impairing the reproductive potential of the embryo.
15784439|NCT04577560|Genetic|PGT-A blastocyst|preimplantation genetic screening for aneuploidies
15784440|NCT04577547|Other|DGA diet WL & exercise|Intake of DGA weight loss 8 day rotating menu & PAGA-recommended exercise
15784441|NCT04577547|Other|DGA diet WL & no exercise|Intake of DGA weight loss 8 day rotating menu & no exercise
15784442|NCT04577547|Other|DGA diet WM & exercise|Intake of DGA weight maintenance 8 day rotating menu & PAGA-recommended exercise
15784443|NCT04577547|Other|DGA diet WM & no exercise|Intake of DGA weight maintenance 8 day rotating menu & no exercise
15784444|NCT04577547|Other|Western diet WL & exercise|Intake of Western-type weight loss 8 day rotating menu & PAGA-recommended exercise
15784445|NCT04577547|Other|Western diet WL & no exercise|Intake of Western-type weight loss 8 day rotating menu & no exercise
15784446|NCT04577547|Other|Western diet WM & exercise|Intake of Western-type weight maintenance 8 day rotating menu & PAGA-recommended exercise
15784447|NCT04577547|Other|Western diet WM & no exercise|Intake of Western-type weight maintenance 8 day rotating menu & no exercise
15784448|NCT04577534|Drug|iv Tocillizumab (TCZ)|Participants are randomized (2:1) to receive TCZ or Standard of Care
15784449|NCT04577521|Device|BioVisc Ortho Single|BioVisc Ortho Single consisted of a prefilled syringe containing 90 mg/3 mL of IA-HA and is an injectable-grade HA from a biofermentation origin. Biovisc ortho single prefilled syringes are intended for single-use only, and the entire content of the syringe was injected into the target joint.
15784450|NCT04577508|Behavioral|Functional Remediation|Functional Remediation is a manualized, group-based psychosocial intervention built on a neurocognitive-behavioural approach, involving modeling techniques, role-playing tasks, self-instruction, positive reinforcement and metacognitive cues (Vieta E et al, Cambridge University Press, 2014). It consists of 21 90-min weekly sessions, in which a trained therapist and co-therapist work with 10-12 patients: the first 3 sessions are dedicated to psychoeducation on neurocognitive deficits; then 13 sessions of neurocognitive training sequentially target attention, memory and executive functions domains, comprising exercises carried out individually, in pairs or in small groups; the last 5 sessions focus on skills training (communication, interpersonal relationships, autonomy, stress management). Content of the sessions involves ecological tasks adapted to real-world situations, and to-be-performed in two contexts (clinical and daily). Homework is assigned, collected and discussed each time.
15784451|NCT04577508|Other|Treatment as usual|Standard care for bipolar disorders according to good clinical practice, including drug therapy and individual case management.
15784452|NCT04577469|Drug|Maldox tablets|500 mg sulfadoxine / 25 mg pyrimethamine to be given as single dose once under fasting condition
15784453|NCT04577469|Drug|G-COSPE® tablets|500 mg sulfadoxine / 25 mg pyrimethamine to be given as single dose once under fasting condition
15784454|NCT04577443|Drug|Adenosine|To investigate the role of adenosine on cerebral hemodynamic and headache in healthy volunteers and migraine patients
15784455|NCT04577443|Drug|Saline|To investigate the role of saline on cerebral hemodynamic and headache in healthy volunteers and migraine patients
15784456|NCT04577430|Drug|Dexmedetomidine|The loading dose with 0.5 μg/kg, maintenance dose with 0.5 μg/kg of Dexmedetomidine is used to observe the effect on the electrophysiology of the patients' hearts
15784457|NCT04577430|Drug|Dexmedetomidine|The loading dose with 1 μg/kg, maintenance dose with 0.5 μg/kg of Dexmedetomidine is used to observe the effect on the electrophysiology of the patients' hearts
15784458|NCT04577430|Drug|Dexmedetomidine|The loading dose with 1 μg/kg, maintenance dose with 1 μg/kg of Dexmedetomidine is used to observe the effect on the electrophysiology of the patients' hearts
15784459|NCT04577430|Drug|Normal saline|Normal saline is used to observe the effect on the electrophysiology of the patients' hearts
15784460|NCT04577417|Drug|ADHD stimulants, for example, amphetamine, dexmethylphenidate, dextroamphetamine, methylphenidate|Both ADHD and control groups of subjects will participate in 2 sessions (on-med and off-med conditions) conducted on the same day. ADHD group will be asked to come to the laboratory in the morning before taking their morning ADHD stimulant medication. They will be tested before and after taking their ADHD medication (off-med and on-med conditions). The investigators will observe changes between the two conditions.
15784461|NCT04577404|Drug|MT-1186|Treatment cycles with daily dosing for 10 days out of a 14-day period, followed by a 14 day drug free period up to 96 weeks of treatment or until the drug is commercially available in that country.
15784462|NCT04577391|Other|Modified Constraint-Induced Movement Therapy|Children's less affected hand was restricted through a mitt with a material sewn shut on the palmar face to promote the involved side's use, and unimanual gross and fine motor activities were practiced with the more affected hand. Besides, if the participant attempted to use his/her less affected hand as an assistive, a bandage was also used to strap less affected upper limb to the trunk. Specific activities were selected according to the deficit of interest, participant preference (on the condition of having potential effects on hand skills) and parent/guardian, or their teacher's request (e.g., drawing, painting, and eating).
15784463|NCT04577391|Other|Bimanual Training|BIT was administrated without any restrictive material on the non-involved upper limb, but instead, children were engaged in age-appropriate gross and fine motor bimanual activities. All targeted deficits of interest were addressed within the context of the selected activity.
15784464|NCT04577378|Drug|Drug: Isotretinoin(Aerosolized 13 cis retinoic acid) plus Aerosolized Itraconazole|After randomization, erosolized 13 cis retinoic acid in gradual one dose increases froms 0.2 mg/kg/day to 4 mg/kg/day as inhaled 13 cis retinoic acid therapy for 14 days plus Aerosolized Itraconazole 5mg per day for 14 days
15784465|NCT04577378|Drug|Drug: Isotretinoin(Aerosolized 13 cis retinoic acid)|Drug: Aerosolized 13 cis retinoic acid in gradual one dose increases froms 0.2 mg/kg/day to 4 mg/kg/day as inhaled 13 cis retinoic acid therapy for 14 days
15784466|NCT04577352|Drug|Vatiquinone|Vatiquinone will be administered per dose and schedule specified in the arm.
15784467|NCT04577352|Drug|Placebo|Placebo will be administered per schedule specified in the arm.
15784468|NCT04577339|Procedure|Laparotomy or laparoscopy|"Laparotomy is the opening of the abdominal cavity usually through a midline incision.
~Laparoscopy is using minimal access keyhole surgery to perform the surgery instead of laparotomy Interventional radiology is the use of imaging to perform a procedure on the abdomen without surgery, for example, using ultrasound to guide a needle to drain an abscess Best supportive care is usually end-of-life care concentration on relieving symptoms rather than treating the cause."
15784469|NCT04577326|Drug|cyclophosphamide|A preconditioning regimen of one dose of intravenous (IV) cyclophosphamide 1.5 g/m^2 will be administered 2-7 days before the infusion.
15784470|NCT04577326|Biological|CAR T cells|A single dose of M28z1XXPD1DNR CAR T cells will be instilled into the pleural cavity via a pleural catheter or through an interventional radiology-guided needle. Cohorts of 3 patients will be treated at each dose level, up to a maximum of 3 x 10^7 T cells/kg or until the MTD has been reached.
15784471|NCT04577313|Behavioral|Behavioral Self-Regulation Adherence Counseling|Telephone-delivered counseling to focus on cognitive-behavioral skills to improve HIV treatment adherence.
15784472|NCT04577300|Drug|NT-501|Implant of Neurotech NT-501 device(s)
15784473|NCT04577300|Other|Sham comparator|Sham implantation
15784474|NCT04577287|Device|Transcranial direct current stimulation|Cathodal/Anodal tDCS will be applied in 1.5 mA, 20 mins before conventional physical therapy for 5 days. All experiments will be performed in random order for each subject.
15784475|NCT04577274|Dietary Supplement|smoothie with regular formulas (SM)|Participants were given 300 kcal of smoothie drink within 3-5 minutes and blood collection after drinking at 30, 60, 90, 120, 180 and 240 minutes. Participants have one week wash out period before try-out other formulas.
15784476|NCT04577274|Dietary Supplement|smoothie with low carbohydrate formulas (SMLS)|Participants were given 300 kcal of smoothie drink within 3-5 minutes and blood collection after drinking at 30, 60, 90, 120, 180 and 240 minutes. Participants have one week wash out period before try-out other formulas.
15784477|NCT04577274|Dietary Supplement|conventional diabetic enteral drinks (Glucerna)|Participants were given 300 kcal of smoothie drink within 3-5 minutes and blood collection after drinking at 30, 60, 90, 120, 180 and 240 minutes. Participants have one week wash out period before try-out other formulas.
15784478|NCT04577248|Device|edge-to-edge valve repair|edge-to-edge valve repair
15784479|NCT04577235|Other|severity of lung involvement with COVID-19.|transthoracic lung ultrasound and throcic CT
15784480|NCT04577222|Procedure|Technical modification during radical prostatectomy|Covering the NVB with fat
15784481|NCT04577209|Device|Disposable oxygen face tent|Disposable oxygen face tent used to minimize aerosol particles (through suction) during aerosol generating anesthesia procedures.
15784482|NCT04577196|Other|Trauma dashboard|A large dashboard available to all, providing a framework for synthesizing and displaying relevant information about the arriving critical patient, to be filled in by the trauma leader.
15784483|NCT04577183|Device|RD1 System|The RD1 is created by drawing the patient's blood with the use of citrate anticoagulant. The anticoagulant allows the clot to form later in a controlled fashion-citrate is a widely used anticoagulant. The blood is then placed in the clotting tray (within few minutes) and the coagulation is facilitated by adding calcium and kaolin (insoluble aluminum silicate). The forming clot assumes the shape of the tray containing it, and can then be applied to the wound, and then covered with primary and secondary dressings.
15784484|NCT04577170|Diagnostic Test|Transcranial Doppler (TCD) and Transcranial Color-Coded Duplex (TCCD) ultrasonography|Transcranial Doppler (TCD) and Transcranial Color-Coded Duplex (TCCD) ultrasonography will be performed in consecutive FD patients. All TCD and TCCD studies will be performed by stroke neurologists experienced in vascular sonography.
15784485|NCT04577157|Behavioral|"mHealth usingWhatsApp multifaceted educational and reminder module intervention to improve adherence"|"This multifaceted educational and reminder module is named Health@click. The content of the reminder module has been made based on The Health Belief Model and self-determination theory.
~Daily notes for medication reminders,
~Daily a voice message with the same content will be delivered.
~Daily Graphics-based Reminder (GBR).
~Twice-weekly Graphics-based Messages (GBM) according to Health believe model and Self-determination theory constituents.
~Once-weekly lifestyle advice through video
~Hypertension at a glance, complete information will be provided(Optional)
~24/7 help provision service will be given to the participants. A qualified doctor will be there to provide this educational support. Support will be including the dose of medicine, frequency, mode of action, effects of medicine on current illness, side effects, and interaction with different foods (Optional)."
15784486|NCT04577144|Other|Online survey only|There are no interventions planned for this study. This is an observational study only.
15784487|NCT04577131|Behavioral|Weekly check-in|Weekly check-in phone calls from a pharmacist to review blood pressures and the number of times tested in that week
15784488|NCT04577118|Device|iotaSOFT Insertion System|Enrolled subjects undergoing cochlear implant surgery will have the iotaSOFT Insertion System used by the surgeon to assist with implantation of the implant electrode array during the procedure.
15784489|NCT04577105|Diagnostic Test|Simple chest tomography|The images were acquired with a Siemens 256-slice multidetector tomograph (SOMATOM DEFINITION FLASH 128x2) following the recommended parameters for low-dose simple chest tomography. The chest topogram was acquired using 35 mA, 100 Kv, and 6 mm slices, then the chest tomographic slices holding inspiration in a cephalocaudal direction with 80 mA, 100 Kv, a duration of 2.24 seconds, a pitch of 1, and slices 1 mm with a total of 110 DLP, which is calculated with the conversion factor for thorax a total of 1.5 mSv. Multiplanar reconstructions with Kernel filters B26f, B50f, and B70 for mediastinum and lung, respectively, at 1 mm slices.
15784490|NCT04577092|Other|Warm-up exercise|In 10-minute warm up period; neck flexion/extension/side flexion/circumflexion (clockwise and counterclockwise), rounding shoulder back and forth, circumflexion of arm back and forth, side flexion of trunk and rising on the fingertips.
15784491|NCT04577092|Other|Motor-Cognitive exercise|After warm up period; participants had been asked to count back from the two-digit number while performing; in standing position, straight walk, side walk, abduction/flexion/extension of hip and hip and knee flexion; in sitting position, hip flexion, knee extension, ankle dorsi - plantar flexion.
15784492|NCT04577092|Other|Motor-Motor exercise|participants had been asked to hold with both hand half-filled glasses with 90 degree of flexion elbow and near the trunk while performing; in standing position, straight walk, side walk, abduction/flexion/extension of hip and hip and knee flexion; in sitting position, hip flexion, knee extension, ankle dorsi - plantar flexion.
15784493|NCT04577092|Other|Cool-down exercise|In 10-minute cool down period, stretching of quadriceps femoris muscle, hamstring muscle, achill tendon and cervical muscles were performed.
15784494|NCT04577079|Device|Evaluation of the need of emergency medical services|The main aim of this study is to validate the use of IPFM in a hospital setting by evaluating the association of IPFM output with 1) clinical urgency and severity of the conditions (using Emergency Severity Index [ESI], an international triaging protocol for emergency units, and an assessment by triage nurse); and 2) actual diagnoses made by the hospital doctors. The objective is also to assess the correlation of IPFM output with redirection or referral to various specialties
15784495|NCT04577066|Other|GA2|15 volunteers will receive 50 GA2-infected mosquito bites. The GA2 parasite is a new genetically attenuated Plasmodium falciparum parasite, which arrests development in the liver and should not be able to cause malaria in humans.
15784496|NCT04577066|Other|GA1|10 volunteers will receive 50 GA1-infected mosquito bites. The GA1 parasite is a genetically attenuated Plasmodium falciparum parasite, which arrests development in the liver and is not able to cause malaria in humans.
15784497|NCT04577066|Other|Placebo|5 volunteers will receive 50 uninfected mosquito bites.
15784498|NCT04577053|Device|Scientific Consciousness Interface Operations (SCIO) Class II FDA approved medical device|Manufactured by QX World Ltd. in Budapest, Hungary
15784499|NCT04577040|Drug|Tadalafil 5mg|Drugs
15784500|NCT04577027|Drug|Topical travoprost 0.004% solution|30 Patches treated with Topical Travoprost 0.004% solution: Topical travoprost 0.004% solution once daily (1 drop for each 2.5 x 2.5 cm2) for 3 months.
15784501|NCT04577027|Device|Fractional CO2 laser|30 Patches treated with Fractional CO2 laser: Fractional CO2 laser sessions twice monthly for 3 months, parameters settings as follows: Energy\ dot 100mj, pulse duration 5ms, density level 17, pattern: array, depth level 1, 2 passes used
15784502|NCT04577027|Device|Excimer laser|30 Patches treated with Excimer laser: Excimer laser sessions will be repeated twice weekly on the selected patch only, The starting dose will be 200 mj /cm2, an increase of 100 mJ/cm2 in the following session if no erythema appears, an increase of 50 mJ/cm2 every session till the appearance of erythema that lasts 24 hours or more.
15784503|NCT04577027|Other|Combination therapy|30 Patches treated with Combination therapy: Fractional CO2 laser twice per month followed by application of topical travoprost 0,004% daily and excimer laser twice weekly .
15784504|NCT04577027|Other|Excimer laser and travoprost|30 Patches treated with Excimer laser twice weekly and topical travoprost once daily for 3 months
15784505|NCT04577027|Other|fractional CO2 laser and topical travoprost|30 Patches treated with fractional CO2 laser twice monthly and topical travoprost once daily for 3 months
15784506|NCT04577014|Drug|Retifanlimab|"Phase I:
~Dose Level 1 - 375 mg (flat dose) Dose Level 0 - 210 mg (flat dose) Dose Level -1 - 375 mg (flat dose) Dose Level -2 - 375 mg (flat dose)
~Phase II: 375 mg (flat dose)"
15784507|NCT04577014|Drug|Gemcitabine|"Phase I:
~Dose Level 1 - 900 mg/m2 Dose Level 0 - 900 mg/m2 Dose Level -1 - 750 mg/m2 Dose Level -2 - 675 mg/m2
~The dose level with ≤ 1 DLT seen per patients will be declared the RP2D.
~Phase II: Participants will be treated with the RP2D of gemcitabine/docetaxel (when administered in combination with Retifanlimab ) for cycle 1, with Retifanlimab added on cycle 2 day 1 at a flat dose of 375mg. Gemcitabine/docetaxel will continue for 5 additional cycles (total of 6 cycles),"
15784508|NCT04577014|Drug|Docetaxel|"Phase I:
~Dose Level 1 - 75 mg/m2 Dose Level 0 - 75 mg/m2 Dose Level -1 - 60 mg/m2 Dose Level -2 - 50 mg/m2
~The dose level with ≤ 1 DLT seen per patients will be declared the RP2D.
~Phase II: Participants will be treated with the RP2D of gemcitabine/docetaxel (when administered in combination with Retifanlimab) for cycle 1, with Retifanlimab added on cycle 2 day 1 at a flat dose of 375mg. Gemcitabine/docetaxel will continue for 5 additional cycles (total of 6 cycles),"
15784509|NCT04577001|Drug|Letrozole|2.5 mg orally daily for 6 months
15784510|NCT04577001|Drug|Placebo|No active ingredient taken orally daily for 6 months
15784511|NCT04576988|Drug|Sotatercept|Sotatercept at a starting dose of 0.3 mg/kg with a target dose of 0.7 mg/kg administered subcutaneously (SC) every 21 days plus background PAH therapy.
15784512|NCT04576988|Drug|Placebo|Placebo administered subcutaneously (SC) every 21 days plus background PAH therapy.
15784513|NCT04576975|Drug|Ketamine|compare the use of ketamine versus dexmedetomidine when used as perioperative infusion in obese patients undergoing laparoscopic bariatric surgery regarding their analgesic efficacy as well as any side effects or drawbacks (PONV and effects on consciousness) that might associate with their use.
15784514|NCT04576975|Drug|Dexmedetomidine|compare the use of ketamine versus dexmedetomidine when used as perioperative infusion in obese patients undergoing laparoscopic bariatric surgery regarding their analgesic efficacy as well as any side effects or drawbacks (PONV and effects on consciousness) that might associate with their use.
15784515|NCT04576975|Drug|Normal Saline 0.9%|compare the use of ketamine versus dexmedetomidine when used as perioperative infusion in obese patients undergoing laparoscopic bariatric surgery regarding their analgesic efficacy as well as any side effects or drawbacks (PONV and effects on consciousness) that might associate with their use.
15784516|NCT04576962|Other|Immunization Information System Review|Extraction of county- and state-level data on HPV vaccine completion from Indiana's Immunization Information System
15784517|NCT04576949|Drug|Cytisinicline|film-coated oral tablets containing 3 mg cytisinicline
15784518|NCT04576949|Drug|Placebo|film-coated oral tablets containing matched placebo
15784519|NCT04576949|Behavioral|Behavioral support|Behavioral support sessions by a qualified study site staff member will be participant-driven and will include direct engagement with the subject about their attempt to quit smoking. Each session will last approximately 10 minutes.
15784520|NCT04576936|Other|AIRVO|Daily, at-home device use of AIRVO device in moderate to severe COPD patients.
15784521|NCT04576923|Diagnostic Test|Liver Incytes|Ultrasound elasticity imaging
15784522|NCT04576910|Biological|vaccinated with Sabin IPV|the 4th dose of polio vaccination
15784523|NCT04576910|Biological|vaccinated with bOPV|the 4th dose of polio vaccination
15784524|NCT04576897|Diagnostic Test|Liver Incytes|Ultrasound elasticity imaging
15784525|NCT04576871|Drug|225Ac-J591|In this study, subject enrollment will be done in a re-treatment design. A single dose of 225Ac-J591 given at the specified dose per cohort. The initial cohort will receive 90 KBq/Kg, or approximately the highest dose administered in prior studies, at which there are 0 of 6 with DLT.
15784526|NCT04576858|Diagnostic Test|Circulating tumor DNA|Measurement of circulating tumor DNA from plasma over a period of 2 years.
15784527|NCT04576845|Other|Survey|The children's eating behavior will be evaluated with Turkish validated Children's Eating Behavior Questionnaire - (CEBQ) by interviewing mothers face to face. The CEBQ is a Likert type, parent-report rating scale measuring the variation in eating behavior in children. The CEBQ consists of 35 items comprising eight subscales, each containing 3 to 6 items. Parents will be asked to rate their child's eating behavior on a five-point scale (never, rarely, sometimes, often, always; 1-5, respectively).
15784528|NCT04576832|Behavioral|Mindfulness-Based Attention Training (MBAT)|Pre-recorded weekly sessions for 4 weeks. Each session will consist of approximately 2 hours of video content per week. This video will include MBAT program lectures, pre-recorded testimony from military leaders, and teaching materials.
15784529|NCT04576832|Behavioral|Measuring Mindfulness App (MMA)|MMA will provide daily mindfulness practice and takes between 10 to 30 minutes to complete. The MMA can be accessed as an application via a smartphone or a computer.
15784530|NCT04576806|Other|Body temperature|Warming of administered fluid bolus
15784531|NCT04576806|Drug|Fluid bolus|Administration of fluid bolus of crystalloid of 500ml over 15 minutes
15784532|NCT04576806|Other|Room temperature|Cooling of administered fluid bolus
15784611|NCT04576208|Drug|Antidiarrheal prophylaxis|Antidiarrheal prophylaxis includes loperamide tablet administered as per routine clinical practice.
15784647|NCT04576000|Drug|Janus Kinase Inhibitor|Janus Kinase inhibitor induction therapy will be administered according to Standard Of Care (SOC)
15784533|NCT04576793|Drug|11C-ER176|11C-ER176 sticks to parts of the brain where there is inflammation. Past studies have shown that inflammation is present in the brains of patients with Alzheimer's disease. The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease. 11C-ER176 will be administered at activity up to 20 millicurie (mCi) per injection.
15784534|NCT04576793|Drug|18F-MK6240|MK-6240 measures a protein called in the brain. MK-6240 is experimental but has been used in several human studies before and has been proven to accurately measure tau in the brain.
15784535|NCT04576793|Drug|18F-Florbetaben|Florbetaben has been approved by the FDA to help diagnose Alzheimer's disease. florbetaben measures amyloid in the brain.
15784536|NCT04576793|Procedure|Lumbar Puncture|Inflammation can also be measured by looking at certain proteins in the spinal fluid. In order to measure these proteins in the spinal fluid, the investigators will perform a lumbar puncture (spinal tap).
15784537|NCT04576780|Other|Integrated Large Complex Polyp Referral Pathway|"The referring doctor will use a standardized template to send the referral along with its associated video or high-resolution photographs.
~Referrals will be reviewed in a consensus fashion by at least 2 expert physicians at St. Michael's Hospital (SMH) on a bi-weekly basis. Polyps will be scored using a standardized evaluation form that documents relevant polyp features to assist the determination of whether a lesion is amenable to curative endoscopic resection.
~Cases will be triaged as being: (1) a standard polyp suitable for local removal in the community; (2) a complex polyp requiring expert removal at SMH with priority assigned based on the suspected risk of invasive disease; (3) a polyp that is not amenable to endoscopic resection or that is suspicious for cancer will that be recommended for surgical resection."
15784538|NCT04576767|Other|anaesthetic|different states of consciousness
15784539|NCT04576754|Device|WB001|The WB001 treatment consists of PPD-specific psychoeducational lessons and CBT-specific skills or tools. The lessons teach PPD-specific information to normalize and contextualize postpartum experiences, as well as provide information on effective mood management and mental health promotion in the context of having recently given birth. Patients complete up to 30 psychoeducational lessons. In addition, patients access and apply core CBT-based tools upon endorsing a negative mood. These tools are core to CBT and are considered transdiagnostic. Examples include thought challenging, behavioral activation, mindfulness, and self-care.
15784540|NCT04576754|Device|Educational|The Comparison Condition provides educational only material about various mental and physical topics, delivered in an interactive smartphone application that is accessible anytime of day.
15784541|NCT04576741|Behavioral|bMBI standard practice|This is a 12-week online mindfulness-based course blended with therapist support via video link using standard practices for Mindfulness-Based Cognitive Therapy (30-minutes/day).
15784542|NCT04576741|Behavioral|bMBI shorter more frequent practice|This is a 12-week online mindfulness-based course blended with therapist support via video link using shorter, more frequent practice than standard Mindfulness-Based Cognitive Therapy (2x15-minutes/day).
15784543|NCT04576728|Drug|Trimodulin|IMP will be administered via IV infusion on 5 consecutive days.
15784544|NCT04576728|Other|Placebo (human albumin 1%)|IMP will be administered via IV infusion on 5 consecutive days.
15784545|NCT04576715|Behavioral|TEaM Intervention|"Multi-setting mTBI (mild traumatic brain injury) Evaluation and Management Intervention incorporates provider education and information technology support systems, based on the best available evidence and tailored to a specific environment (acute care setting vs primary care clinic). Facilitates linkages between providers (ED/UC to primary care) and systems (healthcare to school).
~Provider Training Modules: Training includes decision-making support alerted by positive triage screening and concussion-specific eMR template
~Management based on current best practices (however, may have additional education from the provider training)
~Return to school letters
~Primary Care Follow Up"
15784546|NCT04576715|Behavioral|Standard of Care|"Continue with CHOA current best practices for mTBI:
~No TEaM Provider training (but will be offered to all providers at end of study)
~Will not be trained on utilization and implementation of the concussion screening alert and eMR template"
15784547|NCT04576702|Biological|Investigational aIIV|Investigational MF59 Adjuvanted Quadrivalent Influenza vaccine, containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO (World Health Organization) for quadrivalent vaccines for the respective season.
15784548|NCT04576702|Biological|IIV type 1|Licensed, Non-adjuvanted, Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
15784549|NCT04576702|Biological|aIIV|Licensed, MF59-Adjuvanted, Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
15784550|NCT04576702|Biological|IIV type 2|Licensed, Quadrivalent Influenza Vaccine containing four influenza virus strains (A/H1N1, A/H3N2, B/Yamagata and Victoria lineage) recommended by the WHO for quadrivalent vaccines for the respective season.
15784551|NCT04576689|Drug|IBE-814|Up to 25 participants will receive IBE-814. Route of administration: intravitreal injection.
15784552|NCT04576689|Drug|IBE-814|Up to 25 participants will receive IBE-814. Route of administration: intravitreal injection.
15784553|NCT04576663|Drug|Normal saline|Normal saline infusion simultaneous with subarachnoid block
15784554|NCT04576663|Drug|Phenylephrine|Different infusion dose of phenylephrine simultaneous with subarachnoid block
15784555|NCT04576650|Device|Summit System|Surgical implantation of the Summit system (consisting of one or two Medtronic Activa(R) RC+S grids with wireless communication capabilities) for Safety and efficacy testing of the Medtronic Summit System.
15784606|NCT04576247|Behavioral|Combined aerobic and resistance exercise|"The 12-week intervention will build upon an ongoing resistance exercise program for cancer patients and survivors at the University of Colorado's Anschutz Health and Wellness Center. Resistance exercise will be led by certified cancer exercise specialists who provide individualized exercise programs to cancer patients and survivors. Exercise sessions are progressive, target all major muscle groups, are 50 minutes in duration, and completed 2x/week.
~The intervention will also include 3 self-directed moderate-intensity aerobic exercise sessions/week, building to 50 minutes at 60% heart rate maximum (determined at baseline). Target exercise will be achieved by a gradual progression of exercise duration over the first four weeks of the program."
15784556|NCT04576637|Procedure|Neurophysiological monitoring during intubation|In the operating room patients will be connected to the anesthesia monitor and an IV line as standard clinical practice. Participants will receive oxygen and an IV infusion of 1-3 ng/ml remifentanil via TCI infusion pump to achieve mild sedation. Patients will then be connected to the neurophysiological electrodes to monitor for EEG, EMG, SSEP and MEP signals. After preparing the videolaryngoscope, anesthesia induction will be achieved with the use of IV ketamine 2mg/kg. Then the anesthesiologist will perform a clinical and ECG reading assessment to ensure that the patient is anesthetized and will be able to titrate more ketamine as needed to achieve hypnosis. A biteblock will be located to prevent teeth damage. A neurophysiological baseline recordings will then be performed by a neurophysiologist. The videolaryngoscope will then be inserted, during which a second neurophysiological testing will be performed to ensure the patients safety. Then mechanical ventilation will be initiated.
15784557|NCT04576624|Behavioral|Lifestyle Intervention|A combined approach of a lifestyle structuring intervention to improve the general health and quality of life of persons with cognitive impairments. The investigators propose to combine a multi-modal cognitive intervention and lifestyle redesign approach to improve the cognitive health of older persons with cognitive impairments.
15784558|NCT04576624|Behavioral|social activity|24 social gathering events
15784559|NCT04576611|Other|face-to-face protocol|The intervention is based on education (on pain neurophysiology and healthy lifestyle habits) and physical exercise (strength, flexibility, joint mobility and self-massage).
15784560|NCT04576611|Other|self-managed protocol|Subjects of this group receive the same intervention content as the other experimental group, but through a mobile application.
15784561|NCT04576598|Other|Self-management program to increase physical activity levels|Information and Communication Technologies will be used to carry out various remote sessions. The sessions will address important issues to promote self-management of sedentary lifestyle by stroke survivors. Additionally, a peer support group will be created in order to improve adherence to the program.
15784562|NCT04576598|Other|Education information|Education on the importance of active lifestyle habits post-stroke.
15784563|NCT04576585|Behavioral|Lexicon training|Participants will receive training on the lexicon of appetite on up to 3 days during the training week. This will entail reading written definitions, watching an instructional video, eating exercises and completing training exams demonstrating they understand the distinctions between appetitive terms (hunger, desire to eat, fullness, and prospective consumption). The training will require about 30 minutes to complete. To ensure the success of training, participants must verbally describe the definitions of the outcome sensations to a member of the research team and complete a written quiz with at least 90 % correct responses. Failure to satisfactorily convey understanding of the concepts will result in an offer to repeat the training 2 more times or be rejected from the study.
15784564|NCT04576559|Other|Modified dental visual aids|Modified Dental visual aids in the form of pictures created by the main investigator
15784565|NCT04576559|Other|Regular dental visual aids|Regular dental visual aids
15784566|NCT04576546|Dietary Supplement|D-chiro-inositol|Supplementation of D-chiro-inositol (1000 mg/die), starting at least 4 weeks before rFSH administration
15784567|NCT04576546|Dietary Supplement|Myo-inositol|Supplementation of myo-inositol (4 g/die), starting at least 4 weeks before rFSH administration
15784568|NCT04576533|Behavioral|walk out from operating room|After the surgery of laparoscopic colectomy or laparoscopic rectectomy surgery (Dixon technique), patients will be encouraged to walk out from the operating room and return to the ward by walking under the condition of stable physiological parameters, painlessness, clear consciousness and normal muscle strength of lower limb
15784569|NCT04576520|Procedure|pharmacopuncture therapy|This is a pragmatic RCT, so the physicians will choose the type and volume of pharmacopuncture according to participants' conditions.
15784570|NCT04576520|Procedure|physical therapy|This is a pragmatic RCT, so the physicians will choose the type and time of physical therapy according to participants' conditions.
15784571|NCT04576507|Drug|Cannabis|Investigates two strengths of cannabis.
15784572|NCT04576494|Other|Monthly assessments of functional motor abilities by a trained therapist|Monthly assessments of functional motor abilities in adult 5q-SMA type 2 and type 3 patients by a trained therapist
15784573|NCT04576494|Drug|Nusinersen|nusinersen
15784574|NCT04576481|Behavioral|Text Messaging|Text Messages will be sent to participants using Penn's Way to Health Platform. Participants will be asked to reply to daily text messages on daily shared reading activities including the titles of books and time spent reading.
15784575|NCT04576481|Behavioral|Coaching|Personalized coaching content will be made available to participants through links in the text messages and will provide comparisons of their reading frequency with that of other participants.
15784576|NCT04576481|Behavioral|Lottery|Participants who reply to a text message that they read on a particular day will be entered into daily and weekly drawings to receive cash payments.
15784577|NCT04576468|Procedure|Open flap debridement|Surgical intevention
15784578|NCT04576468|Procedure|perforated membrane|surgical intervention
15784579|NCT04576468|Procedure|leucocyte - platelet rich fibrin|surgical intervention
15784580|NCT04576455|Drug|Giredestrant|Giredestrant is taken orally once per day on Days 1-28 of each 28-day cycle.
15784581|NCT04576455|Drug|Fulvestrant or an Aromatase Inhibitor (Physician's Choice)|Physician's choice of endocrine monotherapy (fulvestrant or an aromatase inhibitor) is taken in accordance with the local prescribing information for the respective product.
15784582|NCT04576455|Drug|LHRH Agonist|Only premenopausal/perimenopausal participants and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist on Day 1 of each 28-day treatment cycle. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.
15784607|NCT04576234|Dietary Supplement|entral feeding|Intermittent enteral feeding group recieved intermittent feeding as the feed was given over a 24 hour period with intervals of rest (e.g. three hours feeding two hours rest)
15784608|NCT04576221|Device|stacked breathing exercise|"• Breath stacking was done using a bag which is a simple device used to give artificial breaths..
~It is best done in a sitting position but can be done reclining or lying flat whichever position is used, try to avoid slouching. If sitting: rest against the back of a chair and keep the shoulders, arms and hands relaxed.
~If using the mouthpiece, place the lips tightly around the mouthpiece to create a tight seal."
15784583|NCT04576442|Behavioral|Asthma-PASS|The investigator will collaborate with the student's primary care provider (PCP) by sending a letter via facsimile, and/or email to ensure appropriate medications are prescribed or adjusted and rescue medications are available at school. Community Health Workers (CHWs) will follow up with PCPs as needed to provide reminders about prescriptions for controlled medications and to ensure a MAF is provided to schools to allow rescue medication administration by nurses. CHWs will work with local pharmacies when possible to have prescribed medications delivered to schools and homes. For students without a PCP, we will refer families to one of Montefiore Medical Center's 20 practices throughout the Bronx. For students without medical insurance or who are unable to go to a Montefiore clinic, the NYC DOE physicians who routinely attend NYC schools will provide medical care and prescribe appropriate medications.
15784584|NCT04576442|Behavioral|Basic Asthma Management (AM)|PCPs and caregivers will be notified that children in the AM group have persistent/uncontrolled asthma that warrants use of guideline-based preventative medications.
15784585|NCT04576442|Behavioral|Child/Caregiver Education session|The investigator will provide in-school child asthma education sessions delivered by trained, bilingual (English-Spanish) Community Health Workers (CHWs) using an established manualized protocol from past and current studies designed to improve knowledge and self-efficacy. Each child will receive two 1-on 1, 20-minute developmentally appropriate educational sessions at school 3-4 weeks apart. Sessions will cover: 1) asthma basics, symptoms and triggers; and 2) medications and correct administration technique. Caregivers will be called after each child session to highlight key points reviewed with the child and answer questions.
15784586|NCT04576429|Procedure|venous puncture|"Venous punctures will be performed:
~for patients of cohort A and B1:
~before the first immune checkpoint inhibitors monoclonal antibodies infusion (baseline);
~between week 6 and week 8 (before the immune checkpoint inhibitors monoclonal antibodies infusion);
~each 3 months up to 12 months.
~for patients of cohort B2:
~before the radiotherapy;
~within the 6 weeks after the end of radiotherapy;
~at the 2 following evaluations (every 3 months)."
15784587|NCT04576429|Procedure|tumoral biopsy|Cutaneous biopsy: superficial skin, or extended skin biopsy, if it is indicated for patient's care.
15784588|NCT04576416|Other|AI augmented training and clinical feedback|"The educational platform has two modules:
~The training module includes AI enhanced case training on a library of 10,000+ benign and malignant skin lesion cases each coupled to written learning modules. Participants will be able to track their progression through automatically generated performance statistics and discuss difficult cases with peers within the application.
~Clinical feedback is defined as diagnostic feedback on all cases registered in the registration module. Feedback during the trial will be based on either histopathology or the consensus agreement of domain experts (if no biopsy is taken). Feedback on referred or dismissed skin lesions will be provided by independent experts in skin cancer diagnostics ( >10 years of experience) through a web-based review system developed by our group."
15784589|NCT04576403|Device|activated mittens|activated mittens (with electronic heat)
15784590|NCT04576403|Device|deactivated mittens|deactivated mittens (without electronic heat)
15784591|NCT04576390|Drug|Ondansetron 4 mg|Antiemetic drug
15784592|NCT04576390|Drug|Palonosetron 75 mcg|Antiemetic drug
15784595|NCT04576364|Drug|Magnesium sulfate for 12 hour|drug used to prevent convulsions in patients having preeclampsia with severe features
15784596|NCT04576364|Drug|Magnesium sulfate for 24 hour|drug used to prevent convulsions in patients having preeclampsia with severe features
15784597|NCT04576351|Other|Observation|The study is a multi-center Norwegian prospective observational clinical study of the occurence of neurological, neuropsychological and psychiatric manifestations and sequelae in patients with COVID-19 at 6- and 12-months follow-up.
15784598|NCT04576325|Drug|Voriconazole Inhalation Powder|For each dose, multiple inhalations will be required (4 capsules in Cohort 1 and 8 capsules in Cohort 2). All capsules for a given dose must be inhaled over a maximum 10-minute period. Cohort 1 will receive 40 mg BID and Cohort 2 will receive 80 mg BID. Both Cohorts will administer study drug for 3.5 days (7 days total).
15784599|NCT04576325|Drug|Placebo|For each dose, multiple inhalations will be required (4 capsules in Cohort 1 and 8 capsules in Cohort 2). All capsules must be inhaled over a maximum 10-minute period. Cohort 1 will receive 4 capsules of inactive BID and Cohort 2 will receive 8 capsules of inactive BID. Both Cohorts will administer placebo capsules for 3.5 days (7 days total).
15784600|NCT04576312|Drug|UNI911 inhalation 1% and intranasal spray 1%|Niclosamide is a broad spectrum, host tageting antiviral that inhibits viral replication (by neutralizing endosomal pH) and increases viral clearance (by increasing the autophagic flux). The niclosamide 1% solution is administered as inhalation by nebulization and intranasal by a nasal spray.
15784601|NCT04576312|Drug|Placebo|The placebo formulation contains the vehicle. The solution is administered in the same way as the active drug. Placebo was only administered for cohorts 1-5.
15784602|NCT04576299|Other|Group 1|Survey about social networks, notification of adverse events, multidisciplinary teams, the doctor-patient relationship, the role of the ethics and patient safety committees, protocol compliance and suspension of outpatient procedures
15784603|NCT04576286|Procedure|Holmium versus Bipolar en bloc transurethral resection|"After obtaining informed consent, patients will be randomized with a 1:1 ratio using sealed envelopes that will be prepared by the department's ethical committee into 2 groups, group 1 represent the Holmium en bloc resection procedure while group 2 represents bipolar en bloc resection. Patients will be blinded to the type of intervention as well as the data collector and the statistician.
~Intervention: all procedures will be done by an expert surgeon who performed over 50 cases of en bloc urinary bladder tumor resection with each energy source. In group A, Holmium en bloc resection procedure will be done under either general or spinal anesthesia, using a Holmium laser device (Cyber Ho, Quanta device, Milano, Italy). We will use a 30-40-watt power, 1-2 joules and 20-30 MHz frequency for Group A and bipolar en bloc resection for Group B. A 550 nm flexible laser fiber will be used in group A and a bipolar resection loop for group B."
15784604|NCT04576273|Diagnostic Test|Pathology examination|Gross and microscopic evaluation
15784605|NCT04576260|Behavioral|Cognitive Behavioural Therapy for Insomnia|Weekly CBTI training
15784609|NCT04576221|Device|NIV by CPAP mask|provides pressurized air through a mask to help push air into your lungs and help you breathe
15784612|NCT04576195|Other|Real PENS|"The technique will be performed ultrasound-guided on the radial nerve, the places of the needle's insertions will be the following:
~Needle will be placed at under the lateral intermuscular septum between the triceps brachii and brachialis, approximately 10cm superior to the lateral epicondyle Needle will be placed at the upper third of the forearm on the posterior interosseous nerve after passing the arcade of Frohse's
~The percutaneous electrical stimulation will be realized with a transcutaneous electric nerve stimulation (TENS) current:
~TENS Frequency 2 Hz TENS Pulse width - 250 microseconds Duration - 30 minutes. TENS Intensity - Increased at an intensity of visible motor response of the innervated musculature and maximal tolerable intensity.
~Administration - One single session."
15784613|NCT04576195|Other|Sham PENS|"The technique will be performed ultrasound-guided on the radial nerve, the places of the needle's insertions will be the following:
~Needle will be placed at under the lateral intermuscular septum between the triceps brachii and brachialis, approximately 10cm superior to the lateral epicondyle Needle will be placed at the upper third of the forearm on the posterior interosseous nerve after passing the arcade of Frohse's
~The electrical current will not be working, and the needles will be placed during 30 minutes:
~- Administration - One single session"
15784614|NCT04576182|Behavioral|Supportive-expressive treatment|Sixteen weeks of a time-limited psychodynamic therapy adapted for depression that includes the use of expressive techniques, such as interpretation, confrontation, clarification and the use of supportive techniques, such as affirmation and empathic validation. This treatment postulates insight as its core mechanism of change.
15784615|NCT04576182|Behavioral|Emotions-Focused treatment|Sixteen weeks of a brief experiential therapy for depression that combine client-centered relational elements (unconditional positive regard, congruence, and empathy) with marker-guided experiential interventions designed to facilitate and deepen emotional processing and emotion regulation.
15784616|NCT04576169|Procedure|Arthroscopic Debridement|A central or radial TFCC tear found during wrist arthroscopy is debrided with a shaver. Portals are closed with sutures or medical tape. The procedure is performed in general or regional anesthesia in operating room. Immediate mobilization of the wrist is allowed after operation. Instructions of home exercise are handed to the patient and patient is instructed to start the exercises two weeks from the operation.
15784617|NCT04576169|Procedure|Placebo surgery|Diagnostic arthroscopy only. A central or radial TFCC tear found during wrist arthroscopy is left untouched and no other operative interventions are done. Portals are closed with sutures or medical tape. The procedure is performed in general or regional anesthesia in operating room. Immediate mobilization of the wrist is allowed after operation. Instructions of home exercise are handed to the patient and patient is instructed to start the exercises two weeks from the operation. The procedure is placebo surgery.
15784618|NCT04576169|Procedure|Arthroscopic or Open Repair|An ulnar TFCC tear found during wrist arthroscopy is sutured to the capsule or fovea with one of the separately defined methods choosed by the treating hand surgeon. The procedure is performed in general or regional anesthesia in operating room. Wounds are closed and standardized post-operative treatment is started after six weeks.
15784619|NCT04576169|Procedure|Physiotherapy|An ulnar TFCC tear found during wrist arthroscopy is left untouched and no other operative interventions are done. Portals are closed with sutures or medical tape. The procedure is performed in general or regional anesthesia in operating room. Physiotherapy exercises of wrist and DRUJ stabilizers is started after two weeks.
15784620|NCT04576156|Drug|Imetelstat|Imetelstat will be given intravenously at 9.4 mg/kg every 21 days, until disease progression or unacceptable toxicity, treatment discontinuation or study end.
15784621|NCT04576156|Drug|Best Available Therapy (BAT)|Non-JAK-inhibitor treatment will be given, which may include but is not limited to hydroxyurea, thalidomide or an analog of thalidomide, interferon, danazol, hypomethylating agents, and chemotherapy.
15784622|NCT04576143|Drug|Epirubicin|i.v. 90 mg/m2
15784623|NCT04576143|Drug|Cyclophosphamid|i.v. 600 mg/m2
15784624|NCT04576143|Drug|Docetaxel|i.v. 100 mg/m2
15784625|NCT04576143|Drug|Paclitaxel|i.v. 175 mg/m2
15784626|NCT04576130|Device|Implantable cardioverter defibrillator|Implantation of an ICD for secondary prevention
15784631|NCT04576104|Drug|Extended Release Metformin Hydrochloride|Given PO
15784632|NCT04576104|Drug|Megestrol Acetate|Given PO
15784633|NCT04576104|Other|Questionnaire Administration|Ancillary studies
15784638|NCT04576078|Drug|Oral nefopam|Oral administration of nefopam 60mg 2 hours before the surgery following by 60mg each 8h for 24h. Oral nefopam is prepared ex-tempore from the intravenous formulation adding a taste masking compound by a non-caring nurse following detailed instructions.
15784639|NCT04576078|Drug|Placebo|Oral administration of a placebo 2 hours before the surgery following by one administration each 8h for 24h. Oral placebo is prepared ex-tempore with a taste masking compound by a non-charge nurse following detailed instructions
15784640|NCT04576065|Other|WFIT|access to nurse practitioner for telehealth visits and activity monitor for 6 months after hospital discharge
15784641|NCT04576039|Diagnostic Test|saline infusion sonography|Instillation of 10cc of saline infusion in the uterine cavity while performing an ultrasonic evaluation of the uterine cavity and endometrium.
15784642|NCT04576026|Behavioral|mental fatiguing task|a 30-minute computerized Stroop test will be used to induce mental fatigue before exercise intervention
15784643|NCT04576026|Behavioral|45 - minute simulated soccer game|an intermittent running protocol using intensities and speeds seen in soccer will be used to simulate the physiological demands of the sport
15784644|NCT04576026|Behavioral|cognitive function|The Stroop test and a complex reaction time test will be used to assess cognitive function during exercise.
15784645|NCT04576013|Device|Peripheral nerve stimulation (PNS)|Non-invasive stimulation is applied to 3 nerves of the arm. The stimulation will be set at a level that is not painful or uncomfortable.
15784646|NCT04576013|Behavioral|Intensive upper extremity motor training|
15784648|NCT04575987|Other|Questionnaire|"Questionnaires will be sent by email or by post, in which questions about PFD, obstetrical history or dietetic follow-up will be asked.
~Some obstetrical issues will be get from women medical files."
15784649|NCT04575974|Other|No intervention|No intervention
15784650|NCT04575961|Drug|Pembrolizumab|Participants receive pembrolizumab 200 mg by intravenous (IV) infusion prior to chemotherapy on Day 1 of each 21-day cycle for up to 35 cycles
15784651|NCT04575948|Drug|Moringa Oleifera|Non toxic Moringa extract with antibacterial and antiplaque effect will be used
15784652|NCT04575948|Drug|Chlorhexidine mouthwash|Commercial 0.12% chlorhexidine digluconate mouthwash twice daily (each morning and before bedtime during the 21-day study period) after intake of food. The patient will be asked to use 15 ml of mouthwash swish it for 60 sec. then expectorate.
15784653|NCT04575948|Drug|Base formula|Base formula is a negative control
15784654|NCT04575935|Drug|Chemotherapy|Receive standard of care chemotherapy
15784655|NCT04575935|Procedure|Laparotomy|Undergo laparotomy
15784656|NCT04575935|Procedure|Minimally Invasive Surgery|Undergo MIS
15784657|NCT04575935|Other|Quality-of-Life Assessment|Ancillary studies
15784658|NCT04575935|Other|Questionnaire Administration|Ancillary studies
15784659|NCT04575922|Drug|Nivolumab|Administered into vein by intravenous infusion every 2 weeks over 6 week study cycle.
15784660|NCT04575922|Drug|Ipilimumab|Administered into vein by intravenous infusion day 1 of each 6 week study cycle.
15784661|NCT04575922|Radiation|Radiation Therapy|3 radiation treatments, every other weekday or 2 days during week 1 of cycle 1 only of study.
15784662|NCT04575909|Behavioral|Emotional Prosody Training|"Recognition: Training will focus on improving participants' understanding of emotional prosody.
~Production-Implicit: Training will focus on improving participants' use of emotional prosody through implicit teaching strategies.
~Production-Explicit: Training will focus on improving participants' use of emotional prosody through explicit teaching strategies."
15784663|NCT04575896|Drug|Glecaprevir/pibrentasvir|Glecaprevir/pibrentasvir 300mg/120mg once daily by mouth for 2 weeks post-transplant.
15784664|NCT04575883|Device|MedBIKE HIIT|Participants will complete a high intensity interval training exercise program 3 times a week for 12 weeks (36 sessions total)
15784665|NCT04575870|Other|waiting period|amount of time between clinical procedure and modified functional endoscopic exam of swallowing
15784668|NCT04575844|Drug|Liraglutide|24 weeks of Liraglutide
15784669|NCT04575844|Other|Exercise training|24 weeks of Exercise training
15784670|NCT04575844|Drug|Liraglutide + Exercise training|24 weeks of Liraglutide + Exercise training
15784671|NCT04575831|Behavioral|Exercise, Nutrition, and Palliative Symptom Management|"Exercise: The exercise intervention is a 12-week group-based program, with 1 weekly 75 minute session focused on strength, balance, flexibility and aerobic capacity.
~Palliative Symptom Management: Palliative symptom management will focus on symptoms that contribute to reduced QOL, limit ability to engage in exercise, or present barriers to oral intake.
~Nutrition: A Registered Dietitian (RD) team will provide feedback and tailored nutrition advice based on a pre-study food recall evaluation, recommending interventions based on the nutrition assessment feedback form, such as oral nutritional supplementation or target daily protein and caloric intake."
15784672|NCT04575818|Drug|GLPG4059 oral suspension|GLPG4059 for oral administration
15784673|NCT04575818|Drug|Placebo|Placebo oral suspension
15784674|NCT04575818|Drug|GLPG4059 tablet|GLPG4059 for oral administration
15784675|NCT04575805|Behavioral|Internet-delivered Combined Cognitive Bias Modification (iCBM-C)|The iCBM-C is online CBM intervention which is the combination of iCBM-I and iCBM-A interventions for obsessive-compulsive symptoms delivered in eight sessions, twice per week for 4 weeks. The presentation order of the two intervention components will be counterbalanced to allow exploration of any order effects. Thereby, half of the participants in iCBM-C group will complete the iCBM-A task followed by iCBM-I, while the other half will complete the iCBM-I task followed by iCBM-A during each session.
15784676|NCT04575805|Behavioral|Internet-delivered Cognitive Bias Modification-Interpretation (iCBM-I)|The iCBM-I is online CBM intervention for obsessive-compulsive symptoms comprised of delivery of OCD related scenarios taking place over eight sessions, twice per week for 4 weeks.
15784677|NCT04575805|Behavioral|Internet-delivered Cognitive Bias Modification-Attention (iCBM-A)|The iCBM-A is online CBM intervention for obsessive-compulsive symptoms comprised of delivery of the modified dot-probe task taking place over eight sessions, twice per week for 4 weeks.
15784678|NCT04575792|Behavioral|Practicing oral habits|children who practice one or more of the specified oral habits ( mouth breathing, object sucking, or tongue thrusting) are considered exposed.
15784679|NCT04575779|Drug|Cyclosporin with a daily dose of 3 mg/kg/day intravenously over 2 h (short infusion) every 12 h|To determine whether administering CsA at a dailydose of 3 mg/kg/day intravenously(i.v.) in 2 hrs (short infusion) twice-daily will achieve C2 blood levels of at least 800 mg/l and whether it will be feasible and safe or not.
15784680|NCT04575766|Drug|FT-7051|"Dose levels: Dose Level -1 through Dose Level 7, assigned per the protocol using a BOIN design. Additional dose levels may be explored as applicable.
~Capsules available in strengths of 10mg, 25mg, and 100 mg that are orally administered per the protocol frequency and dose level."
15784681|NCT04575753|Other|Study group|"Blood samples will be taken from ICU patients on the day of ICU admission, day 2 and day 5 after ICU admission.
~Similarly, patients will be subjected to cognitive testing (CAM-ICU) to determine the presence of delirium"
15784682|NCT04575740|Device|PAP|Positive airway pressure to treat sleep apnea
15784683|NCT04575727|Drug|[11C]MPC6827|Subjects will receive a microdose ( 10 µg) of [11C]MPC6827 (dose of 20 mCi)
15784684|NCT04575714|Other|Data record|Data record
15784685|NCT04575701|Other|TNF Alpha therapy|Retrospective analysis of outcome of first TNF Alpha therapy
15784686|NCT04575688|Drug|Exparel|Exparel will be administered by periarticular injection to patients undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair.
15784746|NCT04575181|Drug|NNC0268-0965|For subcutaneous (s.c., under the skin) injection once daily for 26 weeks
15784687|NCT04575688|Drug|Bupivicaine|Bupivicaine will be administered by popliteal block to patients undergoing hindfoot osteotomy or fusion, ankle osteotomy or fusion, or ankle fracture repair.
15784688|NCT04575675|Drug|Dapagliflozin|Dapagliflozin 10mg once daily
15784689|NCT04575675|Drug|Sacubitril-Valsartan|Sacubitril-Valsartan, maximal tolerated dosage
15784690|NCT04575675|Drug|Beta blocker|Cardio-selective beta-blocker, including carvedilol, bisoprolol, metoprolol or nebivolol
15784691|NCT04575675|Drug|Mineralocorticoid Receptor Antagonist|Mineralocorticoid receptor antagonist, including spironolactone or eplerenone
15784692|NCT04575675|Device|Cardiac resynchronization therapy and/or implantable cardioverter defibrillator|CRT-P, CRT-D or ICD if clinically indicated
15784693|NCT04575662|Radiation|STAR Treatment|Radiation therapy that delivers non-invasive, image-guided, precise high-dose of radiation to targets reducing dose exposure to adjacent normal tissue and minimizing the treatment toxicity.
15784694|NCT04575649|Other|Gastrointestinal anomalies|Infants born late preterm (at or above 35 weeks gestation) and term infants admitted to the NICU with congenital gastrointestinal anomalies, including gastroschisis, omphalocele, esophageal and bowel artesias, tracheoesophageal fistulas, Hirschsprung's disease, or congenital diaphragmatic hernias.
15784695|NCT04575636|Diagnostic Test|Magnetic Resonance Lymphography|Magnetic Resonance Lymphography using Siemens 3T MRI unit and Gadobutrol as a contrast agent to visualize the lymphatic system
15784696|NCT04575623|Diagnostic Test|Duration Pattern test (DPT) /Dichotic Digits Test (DDT) /Auditory fusion test-revised (ART-R)/|"Central auditory function evaluation including:
~Duration Pattern test (DPT) designed to test temporal ordering abilities.
~Dichotic Digits Test (DDT) it assesses binaural integration skills.
~Auditory fusion test-revised (ART-R) to measure temporal resolution.
~speech in test to assess central auditory function."
15784697|NCT04575623|Device|Dual band pure tone audiometer (Orbiter 992). -Impedance audiometer (AT 235h). -Sound treated booth (industrial acoustic company IAC model 1602-A-t) -Panasonic stereo CD player SA-AK 240.|"Cognitive function evaluation including:
~-Recording of event-related potentials (ERPs) by using odd ball paradigm auditoryP300 wave in evaluating cerebral information processing.
~Equipment:
~Dual band pure tone audiometer (Orbiter 992).
~Impedance audiometer (AT 235h).
~Sound treated booth (industrial acoustic company IAC model 1602-A-t)
~Panasonic stereo CD player SA-AK 240."
15784700|NCT04575597|Drug|Molnupiravir|Molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)
15784701|NCT04575597|Drug|Placebo|Placebo matching molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)
15784702|NCT04575584|Drug|Molnupiravir|Molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)
15784703|NCT04575584|Drug|Placebo|Placebo matching molnupiravir administered orally in capsule form every 12 hours for 5 days (10 doses total)
15784704|NCT04575571|Other|No intervention, this is an observational study that uses validated questionnaires and qualitative interviews..|No intervention, this is an observational study that uses validated questionnaires and qualitative interviews.
15784705|NCT04575558|Drug|Hydroxychloroquine and Azithromycin|Hydroxychloroquine 400mg PO BID 2 times a day + Azithromycin 500mg PO QD
15784706|NCT04575545|Diagnostic Test|Serology test for COVID-19|ELISA test
15784707|NCT04575532|Device|Use of the pinpointIQ solution (physIQ, Inc.)|Patients are monitored for 28 days post COVID19 diagnosis or COVID19 post-hospitalization discharge using the pinpointIQ solution.
15784708|NCT04575519|Drug|Control group|placebo 2 months treatment: 2 tablets during 4 weeks + 1 tablet during 4 weeks
15784709|NCT04575519|Drug|ASA group|Acetylsalicylic acid 2 months treatment: 2 tablets during 4 weeks (600 mg daily) + 1 tablet during 4 weeks (300 mg daily)
15784710|NCT04575519|Drug|IBU group|Ibuprofen 2 months treatment: 2 tablets during 4 weeks (800 mg daily) + 1 tablet during 4 weeks (400 mg daily)
15784711|NCT04575519|Drug|SoC TB|Standard of Care Tuberculosis treatment
15784712|NCT04575506|Other|Multidisciplinary intervention program|The intervention program includes an educational program promoting healthy dietary habits and physical activity (nutritionist and exercise physiologist) (2 times/month, for children and parents), and supervised home-based exercise (from 3 to 5 times/week, 38-44 min) program for 12-weeks.
15784713|NCT04575493|Dietary Supplement|Crano-cure|Research literatures have revealed that Tribulus terrestris (Gokhro), Vaccinium macrocarpon (karonda), Cuminum cyminum (Zeera sufaid), Rheum emodi (Revand chini) and Piper cubeba (Kabab chini) are important therapeutic plants. Many pharmacological researches have been done on these plants. For instance, antioxidant, antiseptic, anti-microbial, anti-bacterial, anticancer etc. In the above claims and facts, the study is conducted to formulate and evaluate the polyherbal capsule and to find out the most effective combination having anti-bacterial activity.
15784714|NCT04575493|Drug|Ciprofloxacin 500 mg|Being a standard drug as antibiotic and will be used in Control group.
15784715|NCT04575480|Procedure|Shock Wave Lithotripsy for renal stone.|The following protocol will be applied for all patients in study groups. SWL will be performed using the Dornier Gemini lithotripter (Dornier MedTech, Wessling, Germany) . A total of 3 000 shocks will be delivered at 80 shocks/min. The patient will receive 1 mg/kg pethidine i.v. for analgesia. Treatment will begin at machine power step 1, which will deliver 49 MPa focal pressure and 0.35 mJ/mm2. Power will be gradually increased by one step for each 200 shocks up to step 4, which deliver 70 MPa and 0.7 mJ/mm2. The maximum session number will be 3 session. Patient treated with <2 sessions will be excluded from the analysis
15784716|NCT04575467|Drug|CBL-514|CBL-514 will be administered via injection into the thigh subcutaneous adipose layer.
15784717|NCT04575454|Other|Multimodal evaluation of brain function : PET-MRI, electrophysiology, eye-tracking|"After 2 days of sedation withdrawal, each data should be collected within 3 days for organisation purposes :
~After installation and movement management with standardized routine care protocol: 18Fluoro-Desoxy-Glucose's infusion for PET
~Starting PET continuous acquisition
~Morphological MRI sequences
~MRI in Resting state N°1
~MRI DTI acquisition
~IRM in 2D-Arterial Spin Labelling
~IRM in Resting state 2
~End of PET continuous acquisition The day before or the day after PET-MR: standard 20 min EEG, somaesthetic evoked potentials, auditory evoked potentials, mismatch negativity, P300 oddball paradigm, local-global paradigm, P300 after music stimulation, EEG resting state for 10 min, CRS-R repeated before each examination (and at least 5 times for chronic patients), eye-tracking study of the environmental exploration."
15784718|NCT04575441|Other|Exercise with pilates ball|Pilates ball exercises are used to give various sensory stimulation and increase motor skills. Children usually enjoy these kind of exercises as there is ball in every movement.
15784719|NCT04575428|Drug|Splanchnic nerve block|Percutaneous splanchnic nerve block
15784720|NCT04575415|Drug|Bevacizumab|Bevacizumab 15mg/kg or clinical routine dose by intravenous drip infusion on day 1 of a 21-day cycle
15784721|NCT04575415|Drug|Erlotinib|Erlotinib 150mg, orally once a day
15784722|NCT04575415|Drug|Gefitinib|Gefitinib 250mg, orally once a day
15784723|NCT04575415|Drug|Icotinib|Icotinib 125mg three times a day
15784724|NCT04575415|Drug|Afatinib|Afatinib 40 mg or clinical routine dose once daily
15784725|NCT04575415|Drug|Dacomitinib|Dacomitinib 45mg or clinical routine dose once daily
15784726|NCT04575415|Drug|Osimertinib|Osimertinib 80 mg once daily
15784727|NCT04575402|Other|Wearable Activity Monitor|Continuous monitoring of physical activity including step counts, sleep, heart rate, with consumer-based wearable activity monitor (Fitbit Charge HR4 or similar model)
15784728|NCT04575389|Diagnostic Test|Serum uric acid levels ,HBA1C , fasting plasma glucose ,lipid profile , creatinine level|diagnostic tests
15784729|NCT04575363|Other|Blood sample|Blood sample
15784730|NCT04575350|Genetic|reinterpretation of CNV|Reinterpretation of CNV of unknown significance
15784731|NCT04575324|Behavioral|Telemedicine Linkage Intervention|Participants will be immediately linked to telemedicine care provided by an FQHC provider waivered to prescribe buprenorphine and naltrexone or able to refer patients to methadone treatment. Participants will have their vitals checked and be virtually connected to the provider. The research assistant will share the vitals with the provider, and the provider will provide personalized care during which they discuss treatment options with the participant. If a medication for opioid use disorder is prescribed or if a methadone referral is made, transportation assistance will be provided to the participant as part of the intervention. Transportation to pick up the prescription or complete the first appointment will be provided via a HIPAA compliant ride-share company, and a bus pass will be provided to the participant for the return trip.
15784732|NCT04575311|Drug|AB680|AB680 is a Cluster of Differentiation (CD)73 Inhibitor
15784733|NCT04575311|Other|Placebo|Matching Placebo
15784734|NCT04575298|Dietary Supplement|Acceptability, tolerance study for an infant formula with human milk oligosaccharides|Prospective study
15784735|NCT04575285|Diagnostic Test|Electroencephalogram (EEG)|EEG measures brain activity by recording the spontaneous brain electrical activity and evoked responses non-invasively from the scalp. Reusable Tangle Free 10mm EEG Cup Electrodes will be placed on the subject's scalp using the 10-20 system montage.
15784736|NCT04575272|Procedure|Ultrasound-guided continuous serratus anterior plane block|Local anesthetic infusion though a peripheral nerve catheter placed related to the serratus anterior muscle at the level of the 5th rib
15784737|NCT04575259|Drug|ANAVEX2-73|Oral capsules
15784738|NCT04575233|Procedure|laparoscopic-assisted Transversus Abdominis Plane (TAP) block|"The anterior axillary line is used as landmarks. After insertion of the optic trocar, the peritoneum is visualized. A 14 Gauge needle is inserted 2 cm cranially respect the taken landmark through the skin until the penetration of the internal and external oblique fascias, identified as sudden lowering of resistance. A solution of 15 ml of Ropivacaine (0.2%) is then injected. The procedure is performed then 2 cm caudal to the first landmark on the same side.
~The procedure is than repeated identically on the contralateral side."
15784739|NCT04575233|Procedure|ultrasound-assisted Transversus Abdominis Plane (TAP) block|Whilst the patient is in the supine position, a high frequency ultrasound probe is placed transverse to the abdominal wall between the costal margin and iliac crest. The needle is introduced in plane of the ultrasound probe directly under the probe and advanced until it reaches the plane between the internal oblique and transversus abdominis muscles. Then 15 ml of local anaesthetic solution is injected. The needle is than retracted until its tip is positioned in the fascial plane between the internal and the external oblique muscles and a second bolus of 15 ml of local anaesthetic is injected. The procedure is than repeated identically on the contralateral side.
15784740|NCT04575233|Drug|Ropivacaine|a solution of 15 ml of Ropivacaine (0.2%) is injected for the treatment of post-operative pain after minimally invasive surgery (TAP block)
15784741|NCT04575220|Other|12 weeks of bicycle exercise|Subjects will conduct monitored exercise, three sessions per week for 12 weeks.
15784742|NCT04575207|Diagnostic Test|caFFR|caFFR is a new index of physiological assessment of coronary artery stenosis severity, based on angiographic images. Through two-dimensional analysis and three-dimensional reconstruction of two coronary angiography image series with an angle-off > 30 degrees, combined with fluid mechanics, TIMI frame counting method, and optimized CFD algorithm, the pressure drop from coronary ostium to every point in the vessel can be obtained, and then the caFFR value of each point in the vessel can be computed. The cutoff value in this trial is caFFR ≤ 0.80 for myocardial ischemia.
15784743|NCT04575207|Diagnostic Test|FFR|FFR is a widely used, pressure-based functional assessment index of coronary stenoses obtained with an intracoronary pressure wire fitted with pressure sensors. The pressure wire passes through the stenosis and directly measures the pressure distal to the stenosis. FFR value can be obtained by combining the pressure at the coronary ostium and the distal pressure to the stenosis. The cutoff value in this trial is FFR ≤ 0.80 for myocardial ischemia.
15784744|NCT04575194|Drug|Liraglutide 6 MG/ML [Saxenda]|3 mg of sc liraglutide daily plus lifestyle intervention
15784745|NCT04575194|Drug|Naltrexone-Bupropion Combination|32/360 mg of oral lnaltrexone-bupropion daily plus lifestyle intervention
15784750|NCT04575168|Diagnostic Test|Spartan COVID-19 Test|A nasopharyngeal sample analyzed on the Spartan COVID-19 System.
15784751|NCT04575155|Behavioral|TEAM Strategy|"Pharmacists will have read/write EHR access with established Epic security points
~Pharmacists will initiate medication reconciliation activities by calling the patient for a Comprehensive Medication Review. Pharmacists will add notes in their medication list for the prescriber, requesting the removal or discontinuation of prescribed drugs that patients report they are not taking and adding medications omitted from the provider's list. The pharmacist will provide notifications via secured Epic messaging direct to prescribers of any patient concerns.
~At 6 month if poor adherence is determined, the pharmacist will initiate Therapy Management Review which is a call from the pharmacist to the patient specifically about the medication(s) for which they have poor adherence. If necessary, the pharmacist will create notes and send an in-basket message to the prescriber.
~The prescriber will make changes to the patient's EHR and/or contact the patient as they see fit."
15784752|NCT04575142|Device|CO2 laser|"the CO2 laser (AcuPulse DUO, Lumenis, Yokneam, Israel) generally ranges from 3 to 10 W in superpulse mode, with 0.05 second on/0.01 second off, depending on lesion size and location of the lesion(s).
~The CO2 laser can be used in a continuous, pulsed, or superpulsed mode. The superpulsed mode reduces the exposure time to a few nanoseconds while delivering high energies of 400 to 500 W with each peak. The rest time between each peak allows the tissues to cool and reduces thermal injury to adjacent tissues."
15784753|NCT04575129|Other|No intervention will be applied|No intervention will be applied
15784754|NCT04575116|Drug|Tafamidis free acid tablet|12.2 mg tafamidis free acid tablet
15784755|NCT04575116|Drug|Tafamidis meglumine capsule|20 mg tafamidis meglumine soft gelatin capsule
15784756|NCT04575103|Drug|Antipsychotic|Antipsychotic treatment >0.5 DDD
15784757|NCT04575064|Other|Standard of Care (SoC)|Standard supportive care is expected to vary regionally and may change throughout the trial based on new and emerging data on best care guidelines for patients.
15784758|NCT04575064|Drug|Remdesivir|Remdesivir 200mg IV on day 1, followed by 100 mg IV daily infusion for 9 days or until discharge from hospital, whichever occurs first
15784759|NCT04575051|Behavioral|Consult followed by Engage Model at 5 Months|"The Consult Model (i.e., usual care) is an acute care strategy, relying on a monthly Audiologist visit to the facility.
~The Engage Model is a chronic care approach to supportive hearing loss self-management of ARHL. Engage includes (a) hearing screening for all residents, (b) an individualized communication plan for those with an identified hearing loss (e.g., one-to-one, group, telephone, television plans, hearing aid trouble shooting, communication strategies, etc.), (c) provision of simple, non-custom amplifiers, (d) referral to audiology if needed, and (e) ongoing support provided by trained personnel (Communication Facilitator) under the supervision of the audiologist."
15784760|NCT04575051|Behavioral|Consult followed by Engage Model at 10 Months|"The Consult Model (i.e., usual care) is an acute care strategy, relying on a monthly Audiologist visit to the facility.
~The Engage Model is a chronic care approach to supportive hearing loss self-management of ARHL. Engage includes (a) hearing screening for all residents, (b) an individualized communication plan for those with an identified hearing loss (e.g., one-to-one, group, telephone, television plans, hearing aid trouble shooting, communication strategies, etc.), (c) provision of simple, non-custom amplifiers, (d) referral to audiology if needed, and (e) ongoing support provided by trained personnel (Communication Facilitator) under the supervision of the audiologist."
15784761|NCT04575051|Behavioral|Consult followed by Engage Model at 15 Months|The Consult Model (i.e., usual care) is an acute care strategy, relying on a monthly Audiologist visit to the facility.The Engage Model is a chronic care approach to supportive hearing loss self-management of ARHL. Engage includes (a) hearing screening for all residents, (b) an individualized communication plan for those with an identified hearing loss (e.g., one-to-one, group, telephone, television plans, hearing aid trouble shooting, communication strategies, etc.), (c) provision of simple, non-custom amplifiers, (d) referral to audiology if needed, and (e) ongoing support provided by trained personnel (Communication Facilitator) under the supervision of the audiologist.
15784762|NCT04575051|Behavioral|Consult followed by Engage Model at 20 Months|"The Consult Model (i.e., usual care) is an acute care strategy, relying on a monthly Audiologist visit to the facility.
~The Engage Model is a chronic care approach to supportive hearing loss self-management of ARHL. Engage includes (a) hearing screening for all residents, (b) an individualized communication plan for those with an identified hearing loss (e.g., one-to-one, group, telephone, television plans, hearing aid trouble shooting, communication strategies, etc.), (c) provision of simple, non-custom amplifiers, (d) referral to audiology if needed, and (e) ongoing support provided by trained personnel (Communication Facilitator) under the supervision of the audiologist."
15784763|NCT04575038|Drug|Brequinar|Dihydroorotate dehydrogenase inhibitor (DHODHi)
15784764|NCT04575038|Drug|Placebo|Placebo capsules
15784765|NCT04575025|Drug|Tabrecta tablets|There is no treatment allocation. Patients administered Tabrecta by prescription that have started before inclusion of the patient into the study will be enrolled.
15784766|NCT04575012|Procedure|Deferred invasive strategy|PCI on 7 to 10 days after symptom onset
15784767|NCT04575012|Procedure|Early invasive strategy|Primary PCI
15784768|NCT04574999|Drug|Estriol|Gel for vaginal application
15784769|NCT04574999|Other|Placebo|Gel for vaginal application
15784770|NCT04574973|Device|transcranial direct current stimulation|This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.
15784771|NCT04574973|Behavioral|intensive upper extremity motor training|This training is administered one-on-one with an occupational therapist. Activities will be focused on skills to help the individual function better in daily life.
15784772|NCT04574960|Drug|Gemcitabine|Gemcitabine 1000 mg/m^2, IV infusion on days 1 and 8 of each 3-week cycle
15784773|NCT04574960|Drug|Cisplatin|Cisplatin 70 mg/m^2, IV infusion on day 1 of each 3-week cycle
15784774|NCT04574960|Drug|Carboplatin|Carboplatin AUC 5-6 calculated using the Calvert formula on day 1 of each cycle
15784775|NCT04574947|Drug|Intravenous lidocaine|Lidocaine IV 1.5 mg / kg BMI will be administered during induction into anaesthesia followed by infusion at a dose of 1.5 mg / kg / h until the end of the surgery.
15784776|NCT04574947|Drug|Intravenous placebo|During induction and maintenance of anaesthesia, 0.9% sodium chloride solution will be injected intravenously at a rate equivalent to lidocaine solution.
15784777|NCT04574947|Procedure|Intra-cuff lidocaine|The lidocaine solution will be applied to the intubation tube and the cuff will be filled with an alkalinised lidocaine solution.
15784778|NCT04574947|Procedure|Intra-cuff placebo|The intubation tube will be lubricated 0.9% sodium chloride, the tube cuff will be filled with 0.9% sodium chloride solution.
15784779|NCT04574934|Other|aquatic therapy|Aquatic therapy refers to water-based treatments or exercises of therapeutic intent, in particular for relaxation, fitness, and physical rehabilitation. Treatments and exercises are performed while floating, partially submerged, or fully submerged in water. Many aquatic therapy procedures require constant attendance by a trained therapist and are performed in a specialized temperature-controlled pool. Rehabilitation commonly focuses on improving the physical function associated with illness, injury, or disability
15784780|NCT04574921|Other|Light Therapy System (LTS): Active setting|Exposure for 1 hour á day for consecutive days.
15784781|NCT04574921|Other|Light Therapy System (LTS): Sham setting|Exposure for 1 hour á day for consecutive days.
15784782|NCT04574908|Device|ViSi device|Mobile patient monitoring system for vital signs.
15784783|NCT04574895|Other|Hematology Review|VTE study team will review VTE risk percentages provided via automated report daily on weekdays and approach the primary team directly if the patient is appropriate for clinical antithrombotic interventions.
15784784|NCT04574882|Other|Survey|Interested participants may complete the informed consent online. After informed consent, the participant will be asked to share the digital data types that they use (Facebook, Instagram, Twitter, Google search, step data) and then participants will complete a cross-sectional survey.
15784785|NCT04574869|Drug|RLS-0071|RLS-0071 is a novel peptide that is being developed for the treatment of acute lung injury (ALI) due to coronavirus disease (COVID-19) pneumonia in early respiratory failure.
15784786|NCT04574869|Drug|RLS-0071|RLS-0071 is a novel peptide that is being developed for the treatment of acute lung injury (ALI) due to coronavirus disease (COVID-19) pneumonia in early respiratory failure.
15784787|NCT04574869|Drug|Placebo|The placebo control will be 0.9% Sodium Chloride Injection, United States Pharmacopoeia (USP).
15784788|NCT04574869|Drug|RLS-0071|RLS-0071 is a novel peptide that is being developed for the treatment of acute lung injury (ALI) due to coronavirus disease (COVID-19) pneumonia in early respiratory failure.
15784789|NCT04574869|Drug|RLS-0071|RLS-0071 is a novel peptide that is being developed for the treatment of acute lung injury (ALI) due to coronavirus disease (COVID-19) pneumonia in early respiratory failure.
15784790|NCT04574869|Drug|Placebo|The placebo control will be 0.9% Sodium Chloride Injection, United States Pharmacopoeia (USP).
15784791|NCT04574856|Radiation|Dose-Intensified Radiotherapy|Adaptive, dose-intensified radiotherapy targeting an advanced imaging signature, with a target, nominal radiotherapy dose of 80 Gy.
15784792|NCT04574856|Drug|Temozolomide|Temozolomide chemotherapy (75 mg/m2 daily for 6 weeks)
15784793|NCT04574856|Drug|Adjuvant temozolomide|Adjuvant temozolomide will be delivered at 150-200 mg/m2 days 1-5 every 28 days for 6 cycles, with additional cycles delivered at the discretion of the investigator.
15784794|NCT04574843|Procedure|Embolization of MMA|embolization of MMA with one of following liquid embolic agents (Onyx-Squid-Phil)
15784796|NCT04574817|Drug|HX008|200 mg administered as IV infusion on Day 1 of each 21-day cycle.
15784797|NCT04574804|Other|Online training program in weight management for osteoarthritis|"An evidence based online education training program for physiotherapists in weight management for osteoarthritis. Training modules cover the following topic areas:
~Overweight and obesity and osteoarthritis
~Overview of weight regulation, overweight and obesity
~Examining weight stigma in physiotherapy and personal beliefs about weight
~Communication approach for addressing weight management
~Interventions for weight management
~Health behaviour change support
~These 6 e-learning modules comprise the online training program, access to which comprises the study intervention."
15784798|NCT04574791|Drug|TiZANidine 2 MG Oral Capsule|Tizanidine 2 mg q8h (standing; # 42 tablets) + Multimodal pain regimen
15784799|NCT04574778|Drug|Acetaminophen|1000 mg of oral acetaminophen preoperatively + IV placebo infusion intraoperatively 30 minutes prior to closure
15784800|NCT04574765|Diagnostic Test|Nasopharyngeal swab|Nasopharyngeal swab for COVID-19
15784801|NCT04574765|Other|Questionnaire collection|Fill out questionnaires regarding exposures and travel history, occupation category, any symptoms in the past 21 days, any face-to-face care of a known COVID-19 positive patients in past 14 days or any children at home who are less than 12 years of age.
15784802|NCT04574765|Other|Optional blood completion|Provide blood samples to look for COVID-19 specific antibodies and/or proteins at the time of enrollment and after 8 weeks.
15784803|NCT04574765|Other|Optional questionnaire completion|Fill out an optional mental health questionnaire.
15784804|NCT04574752|Diagnostic Test|next generation sequencing|diagnostic performance of molecular and culture techniques in S. aureus screening using paired nasal and groin swabs, to determine, if any, discrepancy between the diagnostic techniques on S. aureus detection in orthopaedic patients
15784805|NCT04574726|Other|static balance|30-second right and left unipodal static balance test
15784806|NCT04574726|Other|dynamic balance|"for the unipodal dynamic balance test, 4 movements will be done by the volunteers in this order :
~180° elevation of the arms
~lowering of the arms on the side of the single-legged support to the horizontal position
~180° horizontal translation of the arms
~return from the horizontal to the starting point"
15784807|NCT04574713|Drug|Candesartan Oral Tablet 8 mg|1 over-encapsulated tablet once daily, containing candesartan 8 mg, for 12 weeks (84 days).
15784808|NCT04574713|Drug|Candesartan Oral Tablet 16 mg|1 over-encapsulated tablet once daily, containing candesartan 16 mg, for 12 weeks (84 days).
15784809|NCT04574713|Drug|Placebo oral tablet|1 over-encapsulated tablet once daily, containing placebo, for 12 weeks (84 days).
15784831|NCT04574518|Behavioral|TeaM OUT Intervention|The TeaM OUT Intervention has 2 elements: 1) a letter that a) describes the nodule and the importance of cessation related to the pulmonary nodule (i.e. teachable moment) and b) notification that a Proactive IVR Quit line will initiate contact and 2) call(s) from the Proactive IVR Quit Line which a) offers smoking cessation resources and b) helps connect the patient to those resources.
15784862|NCT04574206|Behavioral|Present Tense Talk (PTT)|Parents will be trained to engage their children in conversations, describing activities as they are actually happening.
15784810|NCT04574700|Other|knee joint mobilization and traction|"Grade 3 traction (Kaltenborn)from knee fully flexed to end of available Range of motion(ROM). Traction 30 sec, 10 sec rest period, 4reps, total 2 min of traction.3 sets for a total of 6 min of traction mobilization.Grade3 keltonborn tibiofemoral and tibiofibular anterior, posterior mobilization 3 sets10glides/set, 3 times/week on alternative days for 4 weeks.
~TENS for 20 mins in sitting and strengthening exercises i.e. Quadriceps Setting10 reps, air Cycling 2 min for a bout, straight leg raise (SLR) with weight , Full arc extension 10 reps of each exercise will be carried per session except for full-arc extension and air cycling. Air cycling cont. for 2 min for 1 bout of exercise. Measurement will be taken at base level, after first and last session. Treatment will be given for 3 times/week on alternative days for 4 weeks"
15784811|NCT04574700|Other|Post isometric relaxation|"Control group include Post isometric relaxation technique on hamstring muscle will be performed in supine lying, hip flexed to 90 degrees knee extended until the point of resistance 20% of maximum effort will be used by patient to create isometric contraction. Patient will be asked to breathe in and hold for 5 to 8 seconds and release both breath and effort then move to new barrier point and process was repeated three times per session
~TENS and strengthening exercises as mentioned above.
~This treatment regime will be given for 3 times/week on alternative days for 4 weeks."
15784812|NCT04574687|Other|Neurodevelopmental Techniques|)Conventional treatment protocol including active and active-assissted ROM exercises. (b)Proprioceptive neuro-muscular facilitation techniques. (c)Neuromuscular Developmental Techniques.
15784813|NCT04574687|Other|Action observation Therapy|(a) active range of motion (AROM) exercises (10 min), (b) reaching movement or object manipulation (10 min), and (c) UE functional tasks (15 min). + Conventional treatment protocol as in group A
15784814|NCT04574674|Behavioral|Flexibility exercise programme|Static passive flexibility exercises.
15784815|NCT04574674|Behavioral|Resistance exercise programme|Body weight and resistance bands exercises.
15784816|NCT04574661|Other|Static Stretching|In Control group all the individuals will be asked to perform static stretching for 10 mints, 1 set . Vitals will be monitored from every individual. On 3rd day to this protocol leg circumference, ROM of planter and dorsal flexion and numeric pain rating scale (NPRS ) will be measured alone with all the Vitals from every individual.
15784817|NCT04574661|Other|Intermittent Occlusion|Individuals of Interventional group will be asked to lay down in supine position, apply proximal thigh cuff, 220mg for 12 minutes for intermittent occlusion. During this procedure discomfort will be checked on numeric pain rating scale, if we get 6 on scale, will stop the occlusion. Vitals will be monitored from every individual. On 3rd day to this protocol leg circumference, ROM of planter and dorsal flexion and numeric pain rating scale (NPRS ) will be measured alone with all the Vitals from every individual
15784818|NCT04574648|Device|ActionADE|"ActionADE is a software application that allows healthcare providers to document standardized adverse drug event and non-adherence information in a user-friendly and standardized manner. We integrated ActionADE uni-directionally with PharmaNet, a secure province-wide network that links all pharmacies in British Columbia to a central data system. This allows care providers to pull in demographic information and visualize their patient's medication dispensing history.
~In 2020, we enabled bi-directional integration with PharmaNet allowing clinicians to transmit standardized information back to the PharmaNet database. The three dominant community pharmacy systems in the geographic area of the trial will display non-adherence information in their systems."
15784819|NCT04574635|Procedure|Biospecimen Collection|Undergo collection of blood samples
15784820|NCT04574622|Device|radial Extracorporeal Shockwave Therapy|rESWT was given on gastrocnemius muscles with the subject lying on prone position. No anesthesia was required.
15784821|NCT04574609|Device|Oncomfort® clinical virtual reality|"hypnotherapy arm, patients will receive in addition to the care provided by the usual :
~for PAC insertion: a 45-minute hypnotherapy session 2 hours before the procedure in a room of the outpatient surgery unit (UCA).
~during the entire duration of chemotherapy (and/or immunotherapy for HER2+ patients) : one hypnotherapy session before the first treatment and then every 3 weeks. One hypnotherapy session before the first treatment and then every 3 weeks. Thus, sessions will take place before each treatment for 3-week inter-course regimens and every 3 treatments for chemotherapy administered on a weekly. Each session will last 20 minutes."
15784822|NCT04574596|Other|no Intervention|This is an observational study. There is no intervention
15784823|NCT04574583|Drug|SX-682|SX-682 will be given orally at designated dose twice a day every day
15784824|NCT04574583|Drug|M7824|Subjects will receive M7824 at a flat dose of 1,200 mg intravenously on Days 1 and 15 of each cycle.
15784825|NCT04574583|Biological|MVA-BN-CV301|MVA-BN-CV301 will be given as four subcutaneous injections (4x108 Inf.U/0.5ml twice during Cycle 1 (Days 1 and 15),
15784826|NCT04574583|Biological|FPV-CV301|FPV-CV301 will be given as one subcutaneous injection (1x109 Inf.U/0.5ml) on Day 1 starting at cycle 2 through cycle 5 (every 4 weeks)then on Day 1 of every 3 cycles (Cycles 8 and Cycle 11).
15784827|NCT04574570|Device|High Tibial Osteotomy|Personalised High Tibial Osteotomy (HTO) using a patient-specific fixation plate (TOKA®)
15784828|NCT04574557|Diagnostic Test|micro RNA|"miRNA was isolated from serum using a miRNeasy Mini Kit (Qiagen, Cat; 217004)cDNA was isolated from obtained miRNA samples using a miScript Reverse Transcription Kit (Qiagen, Cat; 218060) Quantitative Real-Time PCR (qPCR) will be done using (miScript SYBR Green PCR Kit Qiagen Cat. No: 218073)The qPCR assays were performed in duplicate The relative expressions of Three miRNAs were selected for RT-PCR validation Two were selected from over-expressed miRNAs (miR-34a, miR-146b), one from under-expressed miRNAs (miR-122) were analyzed using the standard 2-ΔΔCT method. These miRNAs were selected due to their pathophysiological relation with NASH.
~Predicted gene targets of all differentially expressed miRNAs will be identified. Genes with functions that are potentially relevant to the pathogenesis of NASH and gene targets that are commonly studied e.g. lipogenesis (e.g. FAS), inflammation (c-JUN kinase) will be included in the study"
15784829|NCT04574544|Drug|Zinc Supplementation|The 25 supplemented children had received an oral zinc supplement per day for 14 days and had no dietary restrictions.
15784830|NCT04574544|Behavioral|Nutrition education of mothers|Nutritional information was delivered to each mother to facilitate a change in bad eating habits observed, improve knowledge, attitudes and skills of mothers on child nutrition. The anthropometric and biochemistry parameters of children were taken before and after the maternal nutrition education
15785025|NCT04572841|Drug|SAR441344|"Pharmaceutical form: solution for injection
~Route of administration: intravenous or subcutaneous"
15784832|NCT04574518|Behavioral|Enhanced Usual Care|The Enhanced Usual Care arm also has two elements: 1) a letter that a) describes the nodule without linking it to smoking cessation (i.e. no teachable moment) with b) wording to contact an Optional IVR Quit line if desired and 2) the Optional IVR Quit line which a) offers smoking cessation resources and b) helps connect the patient to those resources.
15784833|NCT04574505|Dietary Supplement|Eufortyn Colesterolo Plus|Food supplement combination containing bergamot (Vazguard®) phytosomal polyphenolic fraction associated with standardized artichoke extract (Pycrinil®, Cynara Cardunculus L) and Cynara scolimus, associated with high coenzyme Q10 bioavailability(Q10 phytosome® Ubiqsome) and zinc.
15784834|NCT04574505|Dietary Supplement|Placebo|Placebo
15784835|NCT04574479|Procedure|Supra-inguinal fascia iliaca compartment block|"Ultrasound guided loco-regional technique as described by Desmet et al. Fascia iliaca compartment block with in-plane 40 ml ropivacaine 0,375% injection between the ilio-psoas muscle and the internal oblique muscle.
~Patients in SFICB group have classical multimodal approach to postoperative analgesia with morphine administration by PCA pump"
15784836|NCT04574479|Drug|Multimodal analgesia and PCA morphine pump|Patients in placebo group have classical multimodal approach to postoperative analgesia with morphine administration by PCA pump
15784837|NCT04574466|Behavioral|Problem Management Plus|Problem Management Plus (PM+) is a new, brief, psychological intervention program based on CBT techniques that are empirically supported and formally recommended by the WHO. The full protocol was developed by the WHO and the University of New South Wales, Australia. The manual involves the following empirically supported elements: problem solving plus stress management, behavioural activation, facing fears, and accessing social support. These elements have been recommended in recent WHO guidelines.
15784838|NCT04574453|Device|Iracross|Administration of max 2ml of Iracross at first visit
15784839|NCT04574453|Device|Iraline|Administration of maximum 2 ml of Iraline at visit 1 to visit 3, 4 and 5 depending of suject's need
15784840|NCT04574440|Device|multichannel fNIRS monitoring|Patients who will be enrolled in this study will be monitored during cardiac surgery using multichannel fNIRS monitoring. This consists of wearing the NIRS cap that will be positioned on the patient's head according to international operational guidelines and will be secured to the temporal region of the patient's forehead. The NIRS cap is entirely non-invasive and does not pose any additional risk to the patient. Monitoring will be commenced prior to the induction of anesthesia. Subsequent surgical and medical care will not be affected.
15784841|NCT04574414|Diagnostic Test|Psychological testing and MRI imaging|"Every child will have three sessions with psychologists and be diagnosed as having or not having ADHD.
~Every child will be invited to Krakow to undergo MRI measurements, including resting-state and event-related functional MRI, Diffusion Tensor Imaging (DTI), and T1/T2 structural MRI."
15784843|NCT04574388|Other|open label placebo|open label placebo pill
15784844|NCT04574362|Drug|Rimegepant|One 75mg orally disintegrating tablet
15784845|NCT04574362|Drug|Placebo|Matching placebo
15784846|NCT04574349|Procedure|Decompressive craniectomy|Removing part of the skull (bone flap) to lower intracranial pressure
15784847|NCT04574336|Procedure|Surgical treatment|We anticipate that surgical treatment will include plate osteosynthesis (MIPO and ORIF), intramedullary nailing (antegrade and retrograde) and external fixation. Plate and nail types, screw configuration and surgical approaches will be decided by the surgeon. The procedure will be conducted or supervised by a senior consultant.
15784848|NCT04574336|Device|Non-surgical treatment|Non-surgical treatment will include sugar tong, splint, plaster splints, hanging casts, or functional bracing as the Sarmiento brace and will be worn until a surgeon removes it. If the surgeon deems it appropriate, participants will be offered to undergo early secondary surgery with a surgical procedure of their choice. The participants will be recorded and the reason will be noted. We anticipate the surgical procedures will be similar to the previous mentioned and perhaps with the addition of bone graft.
15784849|NCT04574323|Radiation|Curative radiotherapy|Standard curative radiotherapy
15784850|NCT04574323|Other|Paleolithic lifestyle intervention|This intervention consists of daily outdoor walks or bike rides of at least 30 min duration, preferably done at noon to maximize vitamin D production, and the adoption of a Paleolithic diet. For the outdoor activity, patients were told to not use sun screen. The Paleolithic diet prescription emphasized the consumption of fatty meats and organ meats from humanely raised animals, wild-caught fish, eggs, nuts and seeds, algae, spices, vegetables and fruits. Excluded were processed foods, grains of all types, legumes, vegetable oils except for native coconut and olive oil and dairy products except for ghee. No dietary supplements were allowed.
15784851|NCT04574310|Other|Collect retrospectively data on embryo implantation rate|Collect retrospectively data on embryo implantation rate
15784852|NCT04574297|Behavioral|smoking and alcohol assumption|documenting the change of smoking and drinking status during the follow-up period
15784853|NCT04574297|Diagnostic Test|genetic sequencing|sequencing the susceptibility genes for CP, including serine protease inhibitor Kazal type 1, cationic trypsinogen, cystic fibrosis transmembrane conductance regulator, chymotrypsin C, etc.
15784854|NCT04574284|Drug|TQB2450|TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
15784855|NCT04574284|Drug|Anlotinib|A multi-target receptor tyrosine kinase inhibitor.
15784856|NCT04574271|Behavioral|Intensive dietary advice and exercise prescription|Personalized dietary advice and exercise prescription according to nutritional status.
15784857|NCT04574271|Behavioral|Usual dietary advice and exercise prescription|Generalized dietary advice and excercise prescription in elder patients.
15784858|NCT04574245|Procedure|Gastrectomy; Hepatectomy|
15784859|NCT04574232|Drug|knee intra-articular infiltration with Triamcinolone acetonide|knee intra-articular intra-articular ultrasound-guided infiltration of Triamcinolone acetonide
15784860|NCT04574219|Other|Use of Facetime with child and parents during induction|Families will be able to use Facetime with their child when the child is taken to the operating room
15784861|NCT04574206|Behavioral|Elaborative Reminiscence (ER)|Parents will be trained to use elaborative communication techniques in conversations with their child.
15785181|NCT04571541|Device|Stenting|Effect of endoscopic stenting on healing of esophageal wall defects
15784863|NCT04574193|Device|digital therapeutic for substance use disorders|The Continuing Care application (app) is a HIPAA-compliant, mobile-friendly, software program designed to meet the recovery and personal support needs of probationers and parolees with SUDs who are at elevated risk of relapse, re-arrest, and incarceration.
15784864|NCT04574193|Other|Treatment As Usual|12-weeks of weekly group cognitive behavioral therapy
15784865|NCT04574180|Other|Dental Crown|Pediatric size dental crown; restore damaged tooth to its normal shape, size, and function.
15784866|NCT04574167|Device|Active Transcranial Direct Current Stimulation (tDCS)|Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes.
15784867|NCT04574167|Device|Sham Transcranial Direct Current Stimulation (tDCS)|Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning and end of session).
15784868|NCT04574154|Procedure|FIB|FIB with ultrasound: Ropivacaine 0.5% 40 ml
15784869|NCT04574154|Procedure|ESPB|ESPB (L4) with ultrasound: Ropivacaine 0.5% 40 ml
15784870|NCT04574154|Procedure|spinal anesthesia|bupivacaine 0,5% 2.2 ml
15784871|NCT04574141|Dietary Supplement|a prolonged release tablet and a spray containing melatonin|prolonged release tablet is dosed at 1.9mg and spray is dosed at 1mg for 2 oral sprays.
15784872|NCT04574128|Procedure|No retransfusion of cardiotomy blood|No retransfusion of cardiotomy blood via heart- and lung mashine
15784873|NCT04574115|Device|Omega Refractive Capsule with an FDA approved Intraocular Lens|Omega refractive capsule in conjunction with an FDA approved Intraocular Lens
15784874|NCT04574115|Device|FDA approved Intraocular Lens|FDA approved Intraocular Lens
15784875|NCT04574102|Device|Omega Refractive Capsule with FDA approved Intraocular Lens|Omega Refractive Capsule with FDA approved Intraocular Lens
15784876|NCT04574102|Device|FDA approved Intraocular lens|FDA approved Intraocular lens
15784877|NCT04574089|Drug|Experimental: Baofukang Suppository 7 days|Experimental: Baofukang Suppository 7 days
15784878|NCT04574089|Drug|Experimental: Baofukang Suppository 14 days|Experimental: Baofukang Suppository 14 days
15784880|NCT04574063|Behavioral|Lifestyle intervention to reduce breast cancer risk|Women will be educated about lifestyle factors which increase breast cancer risk. They will also be guided through an online goal setting process.
15784881|NCT04574050|Other|SELF-BREATHE|A self -guided, internet -based intervention for patients with chronic breathlessness
15784882|NCT04574037|Other|Clinical scores such as SAFE score, NIHSS; demographic data such as age and electrophysiological data (such as the absence/presence of Motor evoked potential)|Clinical scores such as SAFE score, NIHSS; demographic data such as age and electrophysiological data (such as the absence/presence of Motor evoked potential) will determine the predictive functional outcome of the upper limb deficit according to the PREP2 algorithm.
15784883|NCT04574024|Drug|NBT-NM108 (60 g/day)|Patients will receive NBT-NM108 at 60 g/day.
15784884|NCT04574024|Other|NBT-NM108 (0 g/day)|Patients will receive NBT-NM108 at 0 g/day.
15784885|NCT04574011|Diagnostic Test|Passive leg raising|Raise the patient's lower limb at a 45 degree angle while lying down
15784886|NCT04573998|Procedure|LSG|bariatric surgery
15784887|NCT04573985|Behavioral|Serious game Eurekoi intervention|1 session in group using the serious game eurekoi
15784888|NCT04573972|Behavioral|Social Incentive|Receiving half the monetary incentive conditional on meeting a step goal and half the monetary incentive conditional on walking together
15784889|NCT04573972|Behavioral|Standard Incentive|Receiving the full monetary incentive conditional on meeting a step goal and not conditional on walking together
15784890|NCT04573959|Device|SV-3 Capsule Endoscopy|The purpose of this study is to validate an updated version of the CapsoCam SV-3 Endoscopy System with respect to the reproducibility of the system to capture and download small bowel images in a manner consistent with the predicate CapsoCam SV-3 capsule endoscopy.
15784891|NCT04573946|Dietary Supplement|Vitamin D3 placebo|Vitamin D placebo
15784892|NCT04573946|Dietary Supplement|Fish oil placebo|Fish oil placebo
15784893|NCT04573946|Drug|Omega-3 fatty acids (fish oil)|Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
15784894|NCT04573946|Dietary Supplement|Vitamin D3|"Vitamin D3 (cholecalciferol), 2000 IU per day.
~Other Names: cholecalciferol"
15784895|NCT04573920|Drug|Atrasentan|Film-coated tablet
15784896|NCT04573907|Drug|Drug Levothyroxine 100 mcg|Administration of a 600 mcg levothyroxine dose
15784897|NCT04573907|Drug|Drug Eutirox 100 mcg|Administration of a 600 mcg levothyroxine dose
15784898|NCT04573894|Diagnostic Test|Procalcitonin dosage|Plasma PCT levels measured by automated enzyme immunoassay (Kryptor).
15784899|NCT04573881|Device|HistoSonics Histotripsy|The HistoSonics system (System) is intended for the destruction of liver tissue using histotripsy, a non-thermal, mechanical process using focused ultrasound.
15784900|NCT04573855|Biological|Anti-SARS-CoV-2 immunoglobulin|Treatment with Anti-SARS-CoV-2 immunoglobulin
15784901|NCT04573842|Other|Ultrasound assessment of SCV|An ultrasound examination of the SCV will be performed before anesthesia induction. Apart from this, the protocol does not differ at all from the ordinary fashion
15784902|NCT04573829|Procedure|Home visit|Psychologist come once a week for the carer and three times a week for the patient
15784903|NCT04573816|Other|Use of an internet plateform|Use of an internet platform for remote monitoring of patients.
15784904|NCT04573803|Drug|Phenytoin Sodium|Dosing will be as prescribed clinically by the treating physician. Phenytoin Sodium may be administered orally, intravenously or via nasogastric tube.
15784905|NCT04573803|Drug|Levetiracetam|Dosing will be as prescribed clinically by the treating physician.Levetiracetam may be administered orally, intravenously or via nasogastric tube.
15784906|NCT04573790|Procedure|eFONA|Surgical Tracheotomy
15784907|NCT04573777|Drug|Repatha|140 MG in 1 ML Prefilled Syringe PCSK9 Inhibitor
15784908|NCT04573764|Dietary Supplement|D-beta-hydroxybutyrate-(R)-1,3 butanediol monoester|"The intervention is D-beta-hydroxybutyrate-(R)-1,3 butanediol monoester and will be bought commercially. As an example: One bottle of KetoneAid KE4 PRO with 60 ml contains 30 g D-beta-hydroxybutyrate-(R)-1,3 butanediol monoester. For more information please refer to: https://shop.ketoneaid.com/collections/all/products/ke4-pro. Placebo will be a taste-matched water solution provided by the company. The placebo solution and the active solution will be prepared in identic bottles and investigators will be blinded."
15784909|NCT04573764|Dietary Supplement|Placebo|Taste-matched water
15784910|NCT04573751|Drug|Standard therapy|Standard therapy as follows: adenosine, nitroglycerine, thrombus aspiration/extraction, and platelet IIb/IIIa receptor inhibitors.
15784911|NCT04573751|Drug|Epinephrine|Standard therapy plus epinephrine as follows: epinephrine, adenosine, nitroglycerine, thrombus aspiration/extraction, and platelet IIb/IIIa receptor inhibitors.
15784912|NCT04573751|Drug|Verapamil|Standard therapy plus verapamil as follows: verapamil, adenosine, nitroglycerine, thrombus aspiration/extraction, and platelet IIb/IIIa receptor inhibitors.
15784913|NCT04573751|Drug|Epinephrine + verapamil|Standard therapy plus epinephrine + verapamil as follows: epinephrine, verapamil, adenosine, nitroglycerine, thrombus aspiration/extraction, and platelet IIb/IIIa receptor inhibitors.
15784914|NCT04573738|Procedure|Robotic assisted transanal total mesorectal excision|Robotic assisted transanal total mesorectal excision for rectal cancer patients
15784915|NCT04573738|Procedure|Laparoscopic assisted transanal total mesorectal excision|Laparoscopic assisted transanal total mesorectal excision for rectal cancer patients
15784916|NCT04573725|Drug|TS-142|Participants received single-dose of 5, 10, 30 mg of TS-142 (oral capsule)
15784917|NCT04573725|Drug|Dose-matched Placebo to TS-142|Participants received single dose-matched placebo to TS-142 (oral capsule)
15784918|NCT04573712|Other|Follow up and Assessment|each patient should wear an actigraph during a week and will be do some tests during 2hours (6min walk, apathy inventory, fatigue severity scale etc...)
15784919|NCT04573699|Device|CNT-HF|A modified CNT, will be delivered as a pacing sequence able to acutely influence sympathetic tone.
15784920|NCT04573686|Drug|Erythropoietin|Erythropoietin will be given subcutenous to all patients
15784921|NCT04573673|Device|PTNS de verum|The device will be set to program P-4: Frequency 20Htz, Pulse duration = 200 µs. The amplitude (Volt) will be adjusted by the patient according to the feeling.
15784922|NCT04573673|Device|PTNS placebo|The device will be set to program P-4: Frequency 20Htz, Pulse duration = 200 µs. A resistor will be incorporated in the device to block the passage of electric current
15784923|NCT04573660|Device|XIENCE PRIME BTK stent|The participants in the XIENCE PRIME BTK arm will receive XIENCE PRIME BTK stent or its competitors/alternative therapies
15784924|NCT04573660|Device|Absolute Pro LL stent|The participants in the Absolute Pro LL arm will receive Absolute Pro LL stent or its competitors/alternative therapies
15784925|NCT04573660|Device|Supera 7.5 OD stent|The participants in the Supera 7.5 OD arm will receive Supera 7.5 OD stent or its competitors/alternative therapies
15784926|NCT04573660|Device|Xpert Pro stent|The participants in the Xpert Pro arm will receive Xpert Pro stent or its competitors/alternative therapies
15784927|NCT04573660|Device|Pacel BPC|The participants in the Pacel Pacing Catheters will receive either Pacel BPC or Pacel FDPC or its competitors/alternative therapies
15784928|NCT04573660|Device|Pacel FDPC|The participants in the Pacel Pacing Catheters will receive either Pacel FDPC or Pacel BPC or its competitors/alternative therapies
15784929|NCT04573660|Device|AVP I|The participants in the Amplatzer Vascular Plugs will receive either AVP I/ AVP II/ AVP 4 or its competitors/alternative therapies
15784930|NCT04573660|Device|AVP II|The participants in the Amplatzer Vascular Plugs will receive either AVP II/ AVP I/ AVP 4 or its competitors/alternative therapies
15784931|NCT04573660|Device|AVP 4|The participants in the Amplatzer Vascular Plugs will receive either AVP 4/ AVP I/ AVP II or its competitors/alternative therapies
15784932|NCT04573660|Device|PressureWire X|The participants in the Pressure Wire will receive PressureWire X or its competitors/alternative therapies
15784933|NCT04573660|Device|MULTI-LINK 8 stent|The participants in the Multilink BMS arm will receive either MULTI-LINK 8 stent/ MULTI-LINK 8 LL/ MULTILINK 8 SV or its competitors/alternative therapies
15784934|NCT04573660|Device|MULTI-LINK 8 LL stent|The participants in the Multilink BMS arm will receive either MULTI-LINK 8 LL stent/ MULTI-LINK 8 stent/MULTI-LINK 8 SV or its competitors/alternative therapies
15784935|NCT04573660|Device|MULTI-LINK 8 SV stent|The participants in the Multilink BMS arm will receive either MULTI-LINK 8 SV stent/ MULTI-LINK 8 stent/ MULTI-LINK 8 LL or its competitors/alternative therapies
15784936|NCT04573647|Drug|Cenegermin-Bkbj 0.002% Ophthalmic Solution [OXERVATE]|Research subjects will use oxervate in affected eye following approved treatment regimen and have their eye measured with optical coherence tomography and a Cochet-Bonnet esthesiometer at various time points before, during and after treatment.
15784937|NCT04573621|Procedure|Pelvic drain|A pelvic drain is placed
15784938|NCT04573621|Other|No pelvic drain is placed|A pelvic drain is not placed
15784939|NCT04573608|Drug|Papacarie|Papacarie was introduced into the cavity using the applicator and left for 40 seconds. A blunt excavator was used to remove the softened dentin. The remaining gel was removed using a cotton pellet. When there was no change in gel color, the cavity was considered caries free. The cavity was then filled with high viscosity glass ionomer cement (GIC) in an encapsulated form (Riva Self-Cure, SDI Limited, Bayswater, VIC, Australia). A mechanical mixer was used to mix the capsule for 10 seconds, the capsule was placed into the applicator to apply the GIC into the cavity. For occluso-proximal cavities, a matrix strip with a wooden wedge was used to provide the appropriate contour of the restoration. A gloved finger was used to apply pressure on the GIC for one minute and occlusion was checked and excess material was removed
15784940|NCT04573608|Drug|Atraumatic Restorative Treatment|The tooth was cleaned with a wet cotton pellet to remove debris and plaque. Caries was removed using sharp spoon excavators (Darby-Perry #220/221, #17 DE, Hu-Friedy, Chicago, USA), followed by cleaning the cavity using a small wet cotton pellet and finally dried with a dry cotton pellet. The cavity was considered caries-free when a leather-hard texture was reached and the excavator did not stick anymore. GIC was used to restore the cavity using the same technique described for the other group.
15785594|NCT04568200|Radiation|Radiotherapy 23 x 1.8 Gy|Radiotherapy 23 x 1.8 Gy
15784941|NCT04573595|Device|Blood Pressure Measurement|The purpose of this study is to provide supporting documentation for Noninvasive blood pressure measurement accuracy claims for Fresenius 5008S BPM Module and Cuffs on the intended population(s). The same arm sequential method with dual observer auscultation will be used to collect data.
15784942|NCT04573582|Drug|Enasidenib|100 mg enasidenib (CC-90007)
15784943|NCT04573569|Behavioral|Behavioral testing|Patients recruited for this study have already undergone surgical implantation of invasive electrodes for purpose of localizing and characterizing electrographic seizures as part of the second phase of surgical epilepsy evaluation. Patients who consent and complete enrollment will then be asked to complete cognitive and behavioral tasks on a portable computer or tablet PC while the invasive electrodes remain implanted. Tasks typically require the patient to think or act and then respond by interacting minimally with the portable computer. These tasks are performed at the will of each patient during their stay in the intensive care unit while surgical electrodes remain.
15784944|NCT04573556|Drug|Lemborexant|Lemborexant oral tablets.
15784945|NCT04573543|Diagnostic Test|Evaluation of the degree of fibrosis and steatosis|The degree of steatosis will be estimated using the controlled attenuation parameter (CAP), a method for grading steatosis by measuring the degree of ultrasound attenuation by hepatic fat using a process based on simultaneous transient elastography (TE) which measures the degree of fibrosis.
15784946|NCT04573543|Diagnostic Test|Screening for the components of metabolic syndrome|"Anthropometric measures including body mass index (BMI), waist circumference (WC), waist hip ratio (WHR), and waist height ratio (WHtR) will be measured in all patients.
~Results of the routine laboratory tests as part of the standard diagnostic procedure will be collected: bilirubin, AST, ALT, GGT, ALP, albumins, WBC, neutrophil-to-lymphocyte ratio, hemoglobin, platelet count, fasting glucose, triglycerides, cholesterol, HDL and LDL. Non-invasive scores of steatosis/fibrosis will be calculated (APRI, FIB4, NAFLD score). Patients will be screened for the components of metabolic syndrome."
15784947|NCT04573543|Diagnostic Test|Measurement of serum semaphorin concentrations|Semaphorin concentration will be measured in patient sera by ELISA.
15784948|NCT04573543|Diagnostic Test|Identification of semaphorin gene polymorphisms|Semaphorin genes will be sequenced to identify semaphorin gene polymorphisms associated with NAFLD.
15784949|NCT04573530|Behavioral|We Walk Plus Intervention|The frequency and content of weekly personalized SMS are based on each participant's preference. Prior to implementation of intervention, the investigators will conduct focus groups to learn participants' social network activities and preferences, strategies that can be used to encourage engagement via a private Fitbit community network.
15784950|NCT04573517|Procedure|Amniotomy|Artificial rupture of amniotic membranes
15784951|NCT04573517|Device|Foley balloon|The Foley balloon is inserted transcervically and inflated to a volume of 60 cc. It may be spontaneously expelled or manually removed if in place for 12 hours.
15784952|NCT04573504|Drug|Augmentin/Flagyl or Augmentin/Clindamycin|Women who suffer a severe vaginal laceration at Prentice Women's Hospital will be randomized to receive 5-days of oral antibiotics or placebo pills after getting a standard one-time dose of IV antibiotics at the time of repair.
15784953|NCT04573504|Drug|Placebo|Placebo
15784954|NCT04573491|Genetic|Pharmacogenetic test|genotyping for genes that affect drug metabolism
15784955|NCT04573491|Other|Medication review|systematic and interdisciplinary method aiming to increase quality of medication treatment
15784958|NCT04573465|Behavioral|Phone Coaching|Participants receiving phone coaching receive one 10-15 minute phone call each week from their randomly assigned peer-support coach. During coaching calls, the peer-support coach will discuss ACT Guide usage with the participant (e.g., asking how many modules the participant completed, asking what the participant liked/disliked about the modules, etc.).
15784959|NCT04573465|Behavioral|Text Message Coaching|Participants receiving text message coaching receive text messages on a weekly basis from their randomly assigned peer-support coach. Text messages from the peer-support coach will discuss ACT Guide usage with the participant (e.g., asking how many modules the participant completed).
15784960|NCT04573465|Behavioral|ACT Guide|ACT Guide is an online self-help program based on acceptance and commitment therapy (ACT), targeting acceptance, mindfulness, and values-based processes. It is intended to be used for 20 to 40 minutes at time, a few times a week. While using ACT Guide, participants will read about concepts relevant to ACT and engage in guided experiential exercises, with additional exercises being assigned to be completed in between sessions as homework.
15784961|NCT04573452|Diagnostic Test|Galectin-3|Measurement of Gal-3 in Serum which will be isolated from the blood samples by ELISA (Enzyme-Linked immunosorbent Assay) (R&D Systems, Minneapolis, MN, USA).
15784962|NCT04573452|Diagnostic Test|Placental Galactin-3|Measurement of Gal-3 in Villous and decidual tissues homogenate by ELISA
15784963|NCT04573439|Dietary Supplement|Dietary Supplement: Dietary supplement: Protein intake|"Oral consumption of hourly experimental meals. Includes 4 meals containing a mixture of free amino acids, carbohydrates and fats from a protein-free formula mixture.
~The last 4 meals will contain labelled 13C phenylalanine."
15784964|NCT04573426|Drug|Acetaminophen|1,000mg liquid acetaminophen
15784965|NCT04573426|Drug|Placebo|Liquid placebo solution
15784966|NCT04573426|Behavioral|Weight stigma vignette|Short vignette meant to induce weight stigma by describing one's rejection for a promotion due to their weight
15784967|NCT04573426|Behavioral|Control vignette|Short vignette meant to have no effect on emotion describing a generic promotion process
15784968|NCT04573413|Device|Inhibitory repetitive transcranial magnetic stimulation|"r-TMS Parameters: International 10/20 system for the location of the target area (left parietal cortex) 60% Power Frequency: 1 Hz 90 pulse trains with 10 pulses each (total 900 stimuli), resulted in a total stimulation period of 15 minutes.
~Visual Scanning Visual-spatial training; Reading and copying training; Copying of line drawings on a dot matrix. Barrage"
15784969|NCT04573413|Device|Sham Group|Sham stimulation and Visual scanning training Intervention: Device: SHAM
15784970|NCT04573400|Other|HADS|"The HADS is a 14-item self-report questionnaire assessing levels of anxiety (seven items) and depression (seven items) over the past week. Each question is assessed on a 4-point Likert Scale: I feel tense or 'wound up' (0= not at all 3= most of the time). Consistent with recommendations by Bjelland et al cut-off of 8 for each HADS subscale will be used to differentiate normal from mild to severe distress."
15784971|NCT04573387|Procedure|Operation|All participants are treated with burr-hole craniotomy and a drainage system as follows. Participants undergo surgical procedure under local anesthesia in the hemisphere with a lateral position, but general anesthesia is performed when participant cannot tolerate the operation. A single 1.5 cm burr hole is drilled over the maximum width of the hematoma cavity. After coagulating with bipolar diathermy, dura mater is opened with a cruciate incision. A soft catheter is placed carefully in all directions of the hematoma cavity for irrigating subdural collections with 1,000 mL warm Ringer's lactate saline until clarification. The drainage catheter is inserted ½ length of the maximum diameter of the hematoma cavity toward the frontal region. After the skin is closed, the catheter was connected to a soft collection bag that is placed under the head for passive drainage. During the drainage period, participants stay in bed until the drain is removed.
15784972|NCT04573387|Procedure|Fixed-time drainage|All participants will be treated with a one-burr-hole craniotomy with irrigation and a closed drainage system. The drainage will be removed after 48 hours.
15784973|NCT04573387|Procedure|Exhaustive drainage|All participants will be treated with a one-burr-hole craniotomy with irrigation and a closed drainage system. If the computed tomography (CT) scan on the first day after surgery indicates that the affected brain region shows sufficient re-expansion, the drainage catheter will be removed when drainage ceases. If subdural collections remain in the hematoma cavity, the participant will be treated with 30,000 U urokinase injection into the hematoma cavity through the catheter. The catheter will be closed and reopened in 1.5-2 hours, and a CT scan will be performed when drainage ceases. If the CT scan shows sufficient re-expansion of the brain, the catheter will be removed. However, if the brain does not show good re-expansion and there is still a residual subdural collection, the above steps will be repeated. If the participant is subjected to urokinase injection for 3 times, the catheter will be removed when drainage ceases.
15784974|NCT04573387|Procedure|Postoperative computed tomography|All participants undergo a CT scan before the drain is removed, and the last CT scan will be performed before the patient is discharged from the hospital.
15784975|NCT04573374|Procedure|Pulpotomy|Pulpotomy is the term for removal of the coronal pulp with the intent of maintaining the vitality of the remaining radicular pulp tissue.
15784976|NCT04573361|Other|Chiropractic care (one visit)|One visit to the chiropractor based on the use of spinal manipulative therapy, mobilization and other forms of manual therapy, exercise therapy, patient education, advice and reassurance
15784977|NCT04573361|Other|Chiropractic care (more than one visit)|More than one visit to the chiropractor based on the use of spinal manipulative therapy, mobilization and other forms of manual therapy, exercise therapy, patient education, advice and reassurance
15784978|NCT04573348|Diagnostic Test|Savicell's ImmunoBiopsy™|ImmunoBiopsy and ELISA
15784981|NCT04573309|Drug|ALXN1840|Administered orally as tablets.
15784982|NCT04573296|Device|Vitadio Health|A 6-month digitally administered behavioral change programme includes personalised nutrition/lifestyle education, remote dietitian's one-on-one coaching, weekly goals, diet and activity monitoring tools, recipes and support member community. Personalization and semi-automation of the intervention is achieved by analysis of participant's interactions with the interface. The programme consists of a 3-month intensive phase, 3-month maintenance phase and aims towards promoting self-management and long-term self-sufficiency.
15784983|NCT04573296|Behavioral|Conventional high-intensity lifestyle intervention programme|A 6-month high-intensity lifestyle intervention programme consisting of face-to-face nutrition/lifestyle education (at baseline, months 1 to 3 and month 6), diet self-monitoring and regular medical assessment (baseline, month 3, month 6).
15784984|NCT04573270|Biological|PrimePro|Intravenous Injection
15784985|NCT04573270|Other|Placebo|Intravenous Injection
15784986|NCT04573257|Other|Echocardiography and pulse wave velocity measurement|Echocardiography(Conventional ultrasonic imaging,tissue Doppler imaging and non invasive myocardial work) and pulse wave velocity measurement
15784987|NCT04573231|Drug|18F-DCFPyL|PSMA is highly expressed on prostate cancer and is associated with metastasis and resistance to anti-androgen therapies. Researchers have evaluated the expression of PSMA in the tumor and tumor-associated neovasculature in primary tumors and distant metastases in patients with breast cancer.
15784988|NCT04573218|Drug|Placebo|The placebo contains glucose
15784989|NCT04573218|Dietary Supplement|250 mg OPP|250 mg Oil Palm Phenolics
15784990|NCT04573205|Drug|FSME-IMMUN Vaccine|0.5 ml intramuscular injection scheduled in the two different arms
15784991|NCT04573192|Drug|L19TNF|Cohort 1: 10 µg /kg L19TNF i.v. plus 90 mg/m2 lomustine Cohort 2: 10 µg /kg L19TNF i.v. plus 110 mg/m2 lomustine Cohort 3: 13 µg /kg L19TNF i.v. plus 110 mg/m2 lomustine
15784992|NCT04573192|Drug|Lomustine|Cohort 1: 10 µg /kg L19TNF i.v. plus 90 mg/m2 lomustine Cohort 2: 10 µg /kg L19TNF i.v. plus 110 mg/m2 lomustine Cohort 3: 13 µg /kg L19TNF i.v. plus 110 mg/m2 lomustine
15784993|NCT04573166|Procedure|Personalized atrial septostomy with combined use of radiofrequency-ablation and balloon-dilation|After left and right catheterization, CURB procedure will be performed in all patients. The first step is RFA on fossae ovalis; and then graded BAS is carried out after transseptal puncture; finally, RFA is repeated around the fenestration-rim created with BAS. The fenestration-size will be determined based on the level of MLAP, and the immediate size of fenestration will be evaluated with intra-cardiac echocardiography. The patency and size of fenestration will be followed up for 6 months. During the period of follow up, the other evaluations will include the improvement in exercise tolerance, major adverse cardiac and/or cerebrovascular events (MACCE), reduction of PAWP/MLAP at rest, cardiac remodeling, myocardial injury, and so on.
15784994|NCT04573153|Drug|Hydroxychloroquine + Metabolic cofactor supplementation|Treatment arm will include dietary supplement consisting of serine, L-carnitine tartrate, N-acetylcysteine and nicotinamide riboside + standard therapy (hydroxychloroquine).
15784995|NCT04573153|Drug|Hydroxychloroquine + Sorbitol|Placebo comparator will include sorbitol as placebo + standard therapy (hydroxychloroquine).
15785026|NCT04572841|Drug|Placebo|"Pharmaceutical form: solution for injection
~Route of administration: intravenous or subcutaneous"
15785702|NCT04567290|Drug|Chewed ticagrelor|Chewed ticagrelor (Brilinta) 90 mg tablets, 2 tablets
15784997|NCT04573127|Other|descriptive study|Retrospective analysis of existing data collected as a part of the regular follow-up
15784998|NCT04573114|Procedure|Verticalization|Progressive levels of verticalization
15784999|NCT04573101|Other|Music listening / EEG recording|Participants listen to 24 different audio clips of 1 min long each, and select emotion in between. EEG is recorded while participants are listening. Participants select the emotion that best describes their feeling from Table 1 of the PANAS-X. https://www2.psychology.uiowa.edu/faculty/clark/panas-x.pdf
15785000|NCT04573088|Behavioral|ACCEPTANCE-BASED INTERVENTION|24 hours prior to surgery the patients undergo acceptance-based intervention, incorporating questions about their subjective perception about the surgery, the domains of their lives that have been affected, and on their own expectations from surgery and its effects on their lives. They will be asked to express their fears and worries about their condition and they will be discussed about the likelihood of experiencing postoperative pain.
15785001|NCT04573075|Procedure|Ghost ileostomy|a loop of the small bowel is marked with a silicone strap and externalized through the abdominal wall to avoid a loop ileostomy
15785002|NCT04573075|Procedure|loop ileostomy|a protective loop ileostomy is applied after after colorectal resection and forming of a primary anastomosis
15785003|NCT04573075|Procedure|no outlet|no further intervention is used after colorectal resection and forming of a primary anastomosis
15785004|NCT04573049|Drug|Levosimendan|On the basis of routine care given by corresponding clinicians, 0.1µg/kg/min levosimendan is given for 24 hours.
15785005|NCT04573049|Other|Placebo|On the basis of routine care given by corresponding clinicians, 0.1µg/kg/min 5% glucose infusion is given for 24 hours.
15785006|NCT04573036|Drug|HRS4800 tablets|single oral administration
15785007|NCT04573036|Drug|Placebo tablets|single oral administration
15785008|NCT04573023|Drug|JR-141|IV infusion, 2.0 mg/kg/week
15785009|NCT04573023|Drug|Idursulfase|IV infusion
15785010|NCT04573023|Drug|JR-141 or Idursulfase|"The subjects who have achieved the pre-specified criteria* are able to change the drug.
~*If a subject in Idursulfase group shows decline in their neurocognitive outcome, idursulfase can be switched to JR-141.
~If a subject in JR-141 group shows decline in their peripheral outcome, JR-141 can be switched to idursulfase."
15785011|NCT04572997|Drug|Apremilast|Apremilast was taken orally twice daily (except Day 1). Patients received tablets in blister/bottles sufficient for one month. To mitigate potential gastrointestinal side effects (primarily mild-to-moderate nausea and diarrhoea), dose titration was implemented in this study in accordance with the Summary of Product Characteristics (SmPC). A titration pack included tablets of 10, 20 and 30 mg for a period of one month. During the first 5 days, the dosage was up-titrated. The initial dose on day 1 was 10 mg in the morning; this was increased to 10 mg in the morning and evening on day 2. The evening dose was further increased by 10 mg (to 20 mg) on day 3. On day 4, the morning dose was increased to 20 mg, so that 20 mg was taken twice daily, and on day 5 the evening dose was increased to 30 mg. From Day 6 onwards, patients received the 30 mg dose twice a day. Subsequent packs included only tablets of 30 mg strength.
15785012|NCT04572984|Procedure|EBUS-TBMCB|endobronchial ultrasound-guided transbronchial mediastinal cryobiopsy was performed in experimental arm following EBUS-TBNA
15785013|NCT04572945|Diagnostic Test|kidney function test|laboratory and imaging
15785014|NCT04572932|Drug|lactobacillus delbruekii|Comarsion between probiotics and one of the most widely used symptomatc treatment for IBS itopride hcl
15785015|NCT04572919|Procedure|lateral advancement flap|Patients were randomly assigned to undergo either lateral advancement flap or classic Limberg flap for treatment of non-complicated pilonidal sinus
15785016|NCT04572919|Procedure|classic Limberg flap|Patients were randomly assigned to undergo either lateral advancement flap or classic Limberg flap for treatment of non-complicated pilonidal sinus
15785017|NCT04572906|Combination Product|NTX-001|One time use surgical product, 3 solutions applied topically, in sequence, to the peripheral nerve repair site, in conjunction with standard suture neurorrhaphy. An isolation chamber medical device (device) is utilized to focus the application of PEG (Solution #2) on the coapted nerve for the required amount of exposure time.
15785019|NCT04572880|Procedure|Trabeculectomy|Trabeculectomy is performed
15785020|NCT04572880|Device|XEN®|Microinvasive Surgery with XEN® is performed
15785021|NCT04572880|Device|Preserflo®|Microinvasive Surgery with Preserflo® is performed
15785022|NCT04572867|Device|Aquapheresis|The Aquadex FlexFlow® Fluid Removal System (from CHF Solutions™, Minneapolis, MN) is an FDA approved device that provides mechanical isosmotic fluid removal in volume-overloaded CHF patients via veno-venous ultrafiltration, and has been used in patients with congestive heart failure refractory to diuretics, it should be considered standard of care also. This study is using it in a randomized, controlled study in the Outpatient setting. The Aquadex FlexFlow® Fluid Removal System is a dual rotary pump device used with a sterile, single-use UF 500 Blood Circuit Set. Blood withdrawal is usually from a peripheral arm vein (such as the antecubital vein), using a 16 or 18- gauge, 3.5 cm catheter (similar to a standard IV catheter). A similar IV catheter is used for blood return via a second peripheral vein (typically in the forearm).
15785023|NCT04572867|Drug|IV Diuretics|Active Comparator: Intravenous Diuretics Per protocol (Fig 2), if randomized to IV diuretic therapy arm (IV), the patient will receive initial dose of IV diuretic based on base line renal function; then the dose will be doubled every 2 hrs if refractory, to a maximum of 8mg IV Bumex (or 320mg IV Lasix). Metolazone may be added at 2.5mg PO 30 minutes before loop diuretic if CR< 2.0, or 5mg PO if Cr > 2.0, if refractory to high dose loop diuretic. If the patient in IV arm is refractory to max 320 mg IV Lasix or 8 mg IV Bumex plus Metolazone then the patient may cross over to AQ arm.
15785024|NCT04572854|Drug|Pegcetacoplan|Complement (C3) Inhibitor
15785027|NCT04572828|Procedure|Paracervical Block|Two-point (at 4 and 8 o'clock only) technique will be used for paracervical block for Group 1: Waiting 1 Minute After Paracervical Block and Group 2: Waiting 3 Minute After Paracervical Block. For these groups 2 ml 2% Prilocaine (VEM İlac, Tekirdag, Turkey) will be injected for each side approximately 10 mm into the cervical stroma at the cervico-vaginal junction with a 22- gauge hypodermic needle.
15785028|NCT04572828|Drug|550 mg Naproxen Sodium 60 minutes before the procedure|550 mg Naproxen Sodium (Abdi Ibrahim, Turkey) will be given to participants in the Group 4, 60 minutes before the procedure.
15785029|NCT04572828|Procedure|The capped needle|The capped needle model will be employed for Group 3: Control Group. After cervical and vaginal preparation with povidone iodine a capped needle will be touched the cervico-vaginal junction at 4 and 8 o'clock.
15785034|NCT04572802|Procedure|Coronary angiography|Coronary angiography was performed in patients with coronary heart disease complicated with type 2 diabetes mellitus
15785037|NCT04572776|Drug|Resiniferatoxin|Resiniferatoxin is a TRPV-1 agonist which works by specifically ablating nociceptive nerve fibers.
15785038|NCT04572776|Other|Standard of Care|Standard of care for intractable pain with the exception of intra-thecal pump placement as determined by the investigator.
15785039|NCT04572763|Drug|Copanlisib|Intravenous infusion
15785040|NCT04572763|Drug|Venetoclax|Tablet taken orally
15785041|NCT04572750|Behavioral|EMPOWER-ED|An electronic app that runs on a variety of platforms and provides education and tools designed to promote self-driven reduction of benzodiazepines.
15785042|NCT04572737|Behavioral|Activity plan to break up sitting time|This research study aims to prove efficacy of a home-based physical activity intervention targeted at reducing periods of prolonged sitting and improving physical function in patients with intermittent claudication.
15785043|NCT04572724|Drug|Sacubitril / Valsartan Oral Tablet|Sacubitril/Valsartan will start at 50mg bid, when blood pressure can be tolerable, the dose will be gradually increased to 100mg bid after taking for 2-4 weeks, and then the target dose is gradually add to the 200mg bid after another 2-4 weeks. Ensure BP>90/60mmHg, the minimum dose is 50mg bid if the patient can't tolerate higher dose but the blood pressure is stable at low dose.
15785044|NCT04572724|Drug|RAS Inhibitors|RAS inhibitor group allows the use of a monodose of any ACEi or ARB. Ensure BP>90/60mmHg, the minimum dose is half dose if the patient can't tolerate monodose but the blood pressure is stable at half dose.
15785045|NCT04572698|Drug|LY09004|LY09004 injection by intraocular injection on Day1, Day29, Day57,Day113, Day169, Day225, Day281 and Day337.
15785046|NCT04572698|Drug|Eylea|EYLEA injection by intraocular injection on Day1, Day29, Day57,Day113, Day169, Day225, Day281 and Day337.
15785047|NCT04572685|Drug|Paliperidone Palmitate|A long acting extended release injectable suspension intended for monthly intramuscular administration
15785048|NCT04572672|Other|Non-pharmacologic treatment; Pursed-Lip Breathing Combined with Number Counting|"Pursed-lip breathing and number counting one and two during inspiration, and then number counting, one, two, three, and four during exhalation. The nurse advised the patient to continue pursed-lip breathing with number counting for the first 15 minutes (min) of each hour to prevent the patient from being exhausted, total study time was 3 hours, or until the patient was discharged from the ER, or was withdrawn from the study."
15785049|NCT04572659|Other|Group psychosocial intervention|Several couples attended a total of six group psychotherapy sessions conducted by a psychologist. Between 4 and 7 couples were treated in each group session.
15785050|NCT04572659|Other|Couple psychosocial intervention|The couple attended a total of six psychotherapy sessions conducted by a psychologist. Each couple was attended particularly.
15785051|NCT04572646|Other|NRT proposition and exhaled CO measurement|"Nicotine replacement therapy is proposed to every patient included in the study.
~Whether the patient accepts the therapy or not, exhaled carbon monoxide is measured at the preoperative consultation (about 15 days before surgery) and the day of surgery by a nurse. These two measures are compared to assess efficacy of nicotine replacement therapy."
15785052|NCT04572633|Device|HistoSonics Histotripsy|The HistoSonics System (System) is intended for the destruction of liver tissue using histotripsy, a non-thermal, mechanical process using focused ultrasound.
15785053|NCT04572620|Drug|Rituximab|375 mg/m2 as 4 weekly consecutive i.v. infusions with subsequent infusions of 375 mg/m2 performed every 3 months for 12 months.
15785054|NCT04572620|Drug|Abatacept|10 mg/kg i.v. every 2 weeks twice, then every 4 weeks for 12 months.
15785055|NCT04572607|Dietary Supplement|The consumption of avocado honey was analyzed|The subjects of honey group consumed 25 g of honey each day for 4 weeks.
15785057|NCT04572568|Other|Multi-disciplinary assessment|"Comprehensive evaluation by multidisciplinary experts;
~Preoperative multi-modal imaging examination was applied to determine the angioarchitecture of AVM."
15785058|NCT04572555|Other|Heat Treatment|Thermoforming was applied to the lower abdomen by the subjects themselves when the dysmenorrhea pain was at its peak.
15785059|NCT04572542|Drug|Camrelizumab|Camrelizumab One course will last 21 days.Given once every 3 weeks at a dose of 200 mg
15785060|NCT04572542|Drug|Apatinib Mesylate|Apatinib One course will last 21 days.Oral administration at a dose of 250 mg everyday
15785061|NCT04572542|Drug|nab-paclitaxel|nab-paclitaxel One course will last 21 days。Given twice every 3 weeks at a dose of 125 mg/m2
15785062|NCT04572529|Procedure|Cardiac Valve replacement|Open heart surgery to replace the valvular infective endocarditis
15785063|NCT04572516|Drug|BTX A Topical|In group A (topical group) ,topical application in the form of merocel soaked with 20 units of BTX_A (2ml) will be placed at each side of the nasal cavity for 30 minutes.
15785064|NCT04572516|Drug|BTX A Injection|In group B (injected group), 20 units of BTX_A(2ml) will be injected submucosally in each inferior turbinate using insulin syringe needle after local anesthesia using 10% xylocaine spray .
15785065|NCT04572503|Procedure|Barbed Suture Modified Anterior Palatoplasty|Barbed Suture Modified Anterior Palatoplasty using single resorbable polydioxanone barbed bidirectional size 0 monofilament suture
15785066|NCT04572490|Diagnostic Test|periapical radiograph|alveolar bone loss measurement on standardized parallel periapical radiograph
15785067|NCT04572477|Drug|[18F]THK-5351|F-18 THK PET Imaging
15785068|NCT04572477|Drug|[18F]AV-45|F-18 AV45 PET Imaging
15785069|NCT04572464|Other|Mindfulness Based Guided Meditation|Mindfulness Based Guided Meditation will be practiced by nurses under the supervision of researcher for 15 min thrice a week for two weeks
15785073|NCT04572438|Procedure|Tracheostomy|Tracheostomy is a procedure that creates a surgical airway in the windpipe to improve oxygenation of the lungs.
15785074|NCT04572425|Other|Guided imagery|10 minutes of guided imagery experience delivered on tablet
15785075|NCT04572425|Other|Virtual reality|10 minutes of virtual reality experience delivered by Facebook Oculus Go VR device
15785076|NCT04572412|Radiation|Low dose Radiotherapy|"External Beam irradiation, single fraction of 0.5Gy, to be delivered within 48 hours of enrolment to study. With field to cover as close to lung edges as AP/PA technique allows.
~A further 0.5GY to the thorax given up to 96 hours apart from first fraction is permitted, if a patient had either (a) responded to the first dose but then deteriorated, however remaining better than baseline level or (b) stabilized after first dose but not fully improved."
15785077|NCT04572399|Device|UV Light Treatment|UV light therapy administered while patient is mechanically ventilated
15785078|NCT04572386|Other|light cure 3m single bond universal bond|light -cure universal bond
15785079|NCT04572386|Other|Self-cure universal bond (Palfique, Tokuyama, Japan)|Self-cure universal bond with no light cure
15785080|NCT04572373|Dietary Supplement|SMOFlipid|
15785081|NCT04572360|Other|Cardiorespiratory Exercise|Each exercise session (40-60 minutes) will include warm-up, aerobic training, resistance training, cool-down, as well as inspiratory muscle training
15785082|NCT04572360|Other|Modified Bai He Gu Jin Tang|The Chinese herbal formula of Modified Bai He Gu Jin Tang will be prescribed in granules. A dose of 10g a day (5g, b.i.d) will be ingested. Patients will dissolve a sachet of granules (5.0g) in 200ml of hot water, twice a day after breakfast and dinner, seven days a week for three months.
15785083|NCT04572347|Other|Observational|It is an observational study, and no intervention will be provided.
15785084|NCT04572334|Other|Auto and Subjective Refraction|All patients will be measured with three autorefractometers and two independent observes will perform subjective refraction
15785085|NCT04572308|Biological|CD7 CAR-T|"Patients will be treated with CD7 CAR-T cells
~Biological: CD7 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;"
15785086|NCT04572295|Drug|E7090|E7090 oral tablet.
15785087|NCT04572295|Drug|Fulvestrant|Fulvestrant intramuscular injection.
15785088|NCT04572295|Drug|Exemestane|Exemestane oral tablet.
15785089|NCT04572282|Device|Mentora app|Remote monitoring mobile app
15785090|NCT04572269|Other|No Intervention|This protocol does not involve an intervention of drug/device, diet, exercise or PAP compliance.
15785091|NCT04572256|Drug|Montelukast|The novel use of oral montelukast offers the potential of a disease modifying treatment to prevent irreversible cartilage loss after ACL injury. 10mg of oral Montelukast will be taken daily for 6 months post surgery.
15785092|NCT04572256|Drug|Placebo|An oral placebo will be taken daily for 6 months post surgery.
15785093|NCT04572243|Drug|Placebo|Placebo matching to lorcaserin oral tablet, administered as oral suspension.
15785094|NCT04572243|Drug|Lorcaserin|Lorcaserin oral tablet, administered as oral suspension.
15785095|NCT04572230|Device|Endovascular treatment of intracranial aneurysms using a flow-diverting stent|The flow diverter brings about a reduction of blood flow to the aneurysm, which progresses over time into forming a stable thrombus within the aneurysm, as well as eventual aneurysm scarring and retraction. The flow diverter also acts as a scaffold for tissue growth across the neck of the aneurysm, which blocks the aneurysm from the artery blood flow.
15785096|NCT04572217|Drug|Topiramate|Topiramate (starting dose 25 mg daily, max dose 100 mg daily)
15785097|NCT04572217|Drug|Phentermine|Phentermine (starting dose 8 mg, max dose 16 mg)
15785098|NCT04572204|Other|Surgical|Minimal: Such as PCN insertion Endosopic: Such as DJ insertion Surgical: Repair, Partial or total nephrectomy Angioembolization
15785099|NCT04572191|Diagnostic Test|CERAMIDE LEVEL IN BLOOD|BY ELISA ASSAY TO DETECT CERAMIDE LEVEL IN BLOOD IN ANTERIOR STEMI PATIENTS
15785100|NCT04572178|Behavioral|Cash payment and brief behavioral counseling|"The intervention consists of: (i) in person brief behavioral counseling, (ii) the evaluation of the smoking status using breath carbon monoxide, and (iii) cash payment of 25 Euro if the reading does not exceed a carbon monoxide value 3 ppm ( ppm = parts per million) on two consecutive measurements per week. The intervention starts at the earliest in pregnancy week 15 and lasts until the delivery. If they relapse, the reward is not paid. However, in the following week they have the opportunity to quit smoking and being rewarded again."
15785703|NCT04567290|Drug|Swallowed ticagrelor|Swallowed ticagrelor (Brilinta) 90 mg tablets, 2 tablets
15785101|NCT04572165|Drug|Ozempic®|Patients have been treated with commercially available Ozempic® according to local label and to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available Ozempic® had been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study.
15785102|NCT04572165|Drug|Active Comparator|Patients have been treated with commercially available active comparators according to local label and to routine clinical practice at the discretion of the treating physician. Active comparators will include the following antidiabetic agents: sulphonylureas, sodium-glucose co-transporter 2 inhibitors, and insulin. The decision to initiate treatment with commercially available active comparators had been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study.
15785103|NCT04572165|Drug|Rybelsus®|Patients have been treated with commercially available Rybelsus® according to local label and to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available Rybelsus® had been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study.
15785106|NCT04572139|Diagnostic Test|Pituitary stimulation test|Pituitary stimulation with 0.1 mg LHRH, 0.2 mg TRH and 0.25 mg ACTH
15785107|NCT04572126|Behavioral|Mindfulness Intervention|The mindfulness intervention includes strategies to cope with substance cravings based on previously published mindfulness techniques. Examples of strategies presented include paying close attention to sensations, acceptance of cravings, and self-kindness.
15785108|NCT04572126|Behavioral|Control Intervention|The control intervention instructs participants to utilize their own, previously used strategies to cope with substance cravings.
15785109|NCT04572113|Device|Cervical collar|Data will be recorded while patients are not wearing or wearing one of two cervical collars
15785110|NCT04572100|Other|Transoral Robotic Surgery (TORS) or Radiotherapy|Participants assigned to this group will receive transoral robotic surgery (TORs) or radiotherapy. Radiotherapy is given once a day for 5 weeks. A percentage of subjects who undergo surgery may need further radiotherapy with or without chemotherapy based on the results of the surgery. TORs is surgery in which a robot with arms is used to remove cancer from hard-to-reach areas of the mouth and throat.
15785111|NCT04572100|Other|Chemotherapy and Low-Dose Radiotherapy|Participants assigned to this group will receive 5 weeks of chemotherapy combined with low- dose radiotherapy.
15785112|NCT04572100|Other|Chemotherapy and High-Dose Radiotherapy|Participants assigned to this group will receive 7 weeks of chemotherapy combined with high- dose radiotherapy.
15785113|NCT04572100|Drug|Paclitaxel|This drug will be combined with carboplatin during induction therapy for 9 weeks.
15785114|NCT04572100|Drug|Carboplatin|This drug will be combined with paclitaxel during induction therapy for 9 weeks.
15785115|NCT04572087|Other|Behavioral training and verum stimulation|Cognitive control training and verum tDCS
15785116|NCT04572087|Other|Behavioral training and sham stimulation|Cognitive control training and sham tDCS
15785117|NCT04572074|Other|Guided imagery|10 minutes of guided imagery experience
15785118|NCT04572074|Other|Virtual reality|10 minutes of virtual reality experience
15785119|NCT04572048|Other|Single-day NRP Training|NRP training course completed in one single day of 8 hours
15785120|NCT04572048|Other|longitudinal NRP training|NRP training course completed over one year by attending nine 30-minute modules.
15785121|NCT04572035|Behavioral|Behavioural Coaching|behaviour change strategies (i.e., action planning, implementation intentions, relapse prevention, and goal setting)
15785122|NCT04572035|Behavioral|Self-compassion psychoeducation|self-compassion strategies (i.e., mindfulness, self-directed kindness meditations, and writing tasks)
15785123|NCT04572035|Other|Exercise|aerobic exercise program either delivered in a laboratory setting or via Zoom
15785124|NCT04572022|Other|Step wise post-procedure mobile health shared rehabilitation teaching video instructions modules (as per fracture type)|Intervention group receive proximal humerus fracture standard care with additional mobile health shared step-wise rehabilitation teaching video instructions modules (as per fracture type). Classic Blue tooth technology will be utilized for teaching information sharing from doctor to the patient.
15785125|NCT04572009|Other|Bio-mathematical model|bio-mathematical model to help the physician identify the parameters of flexible insulin therapy (basal rate, insulin sensitivity, carbohydrate ratios)
15785126|NCT04572009|Other|Without bio-mathematical model|No bio-mathematical model to help the physician identify the parameters of flexible insulin therapy (basal rate, insulin sensitivity, carbohydrate ratios)
15785127|NCT04571996|Drug|ODM-104|Capsule
15785128|NCT04571996|Drug|Paracetamol|Rapidly dissolving tablet
15785129|NCT04571983|Other|Blood Eosinophil counts - comparing historical with stable state|Comparing historical blood eosinophil counts over 24 months to stable state eosinophil count.
15785130|NCT04571970|Genetic|RGX-121|Recombinant adeno-associated virus serotype 9 capsid containing human iduronate-2-sulfatase expression cassette
15785131|NCT04571957|Other|No Intervention|No Intervention
15785134|NCT04571918|Procedure|Biodegradable spacer|Implantation of a biodegradable balloon used as a subacromial spacer.
15785135|NCT04571918|Procedure|Debridement and biceps tenotomy|Surgery with arthroscopic debridement and biceps tenotomy
15785136|NCT04571905|Device|Osteosynthesis with resorbable Material|Osteosynthesis with Magnezix screws in fractures of the Epicondylus ulnaris and Condylus radialis under General anaesthesia
15785159|NCT04571723|Behavioral|Health Mindset modified diabetes prevention program|This is the established diabetes prevention program curriculum with the addition of curriculum focused on the role of mindset in health.
15785160|NCT04571710|Drug|SHR1258|Drug: SHR1258 400mg
15785137|NCT04571892|Biological|Super circulating tumor infiltrating lymphocytes(ScTIL)|"Peripheral blood mononuclear cells (PBMCs) are used for cell preparation. PD-1(programmed death 1) positive T cells are isolated from peripheral blood by blood cell apheresis method and transduced with lentivirus loaded with enhanced receptor and superamplification factor. The obtained ScTIL is used for one-time intravenous infusion."
15785138|NCT04571879|Drug|Nebulized Lidocaine|Nebulized Lidocaine for Reducing Pain of Nasogastric Tube Insertion in Children
15785139|NCT04571879|Drug|Intranasal Midazolam|Intranasal Midazolam for reducing anxiety of Nasogastric Tube insertion
15785140|NCT04571879|Other|Placebo|Nebulized normal saline and intranasal normal sline
15785141|NCT04571866|Other|Beta-glucan bread|Beta-glucan is a dietary fiber with beneficial health effects, both on cholesterol levels and potentially blood glucose levels.
15785142|NCT04571853|Behavioral|PNE-explained group|There are 9 fact sheets overall. And each fact sheet incorporates two pages relating to one main concept. The first of two pages introduces the concept, and the second one quotes important ideas that emerge from the main concept. The 9 main concepts and consequent ideas presented in the fact sheets are based on current scientific research in pain science and have been selected and structured specifically for PNE education for chronic pain patients. The fact sheets have been fully developed and designed by Pain Revolution, a pain educator network founded by Professor Lorimer Moseley, group leader in Body in Mind Research Group from University of South Australia.
15785143|NCT04571853|Behavioral|PNE-read group|The PNE-read group will receive the fact sheets via email along with instructions regarding the content and the procedure to read the content. Instructions will suggest to read only two fact sheets per day during 4,5 days. It will be suggested to take 30 minutes at least for each fact sheet.
15785144|NCT04571853|Behavioral|TAU group|Participants allocated to this group will maintain treatment as usual (TAU) and will follow the recommendations by their usual health professiona
15785145|NCT04571840|Diagnostic Test|Multiparametric MRI +/- prostate biopsy|MRI with T2-weighted, diffusion weighted and dynamic contrast enhanced sequences followed by prostate biopsy if indicated on MRI and clinical findings
15785146|NCT04571840|Diagnostic Test|Biparametric MRI +/- prostate biopsy|MRI with T2-weighted and diffusion weighted sequences followed by prostate biopsy if indicated on MRI and clinical findings
15785147|NCT04571827|Other|Dry Needling|"Deep dry needling procedure
~All subjects received a deep dry neddling technique on a latent myofascial trigger point of the upper trapezius muscle by isolating it by a pincer grasp with the thumb and index finger. This myofascial trigger point was previously found following the diagnostic criteria described by Travell & Simons and Fernández-de-las-Peñas et al., and the deep dry needling intervention applied was based on the technique described by Hong.
~The patients were placed in a prone position. Prior to the technique, the area was disinfected with an antiseptic solution. Fifteen incisions were made with a 0.26x40mm monofilament needle. The number of local twitch response made were noted. After removing the needle, at the end a soft compression was made with a cotton to reduce the possible appearance of bleeding."
15785148|NCT04571814|Behavioral|Psycho-social, computerized intervention targeting error sensitivity|"A psycho-social, computerized intervention for parents and children targeting error sensitivity. This intervention will be based on the constructs in the Child Error Sensitivity Index, as well as other constructs, that relate to the error-related negativity - for example, perfectionism, fear of evaluation from others, and over-valuation of the negative consequences of errors. The parent version of the intervention will include these same basic concepts, but will also target parenting style and provide psychoeducation on the negative impact of over-reacting to children's mistakes.
~The parent version will also include examples of how to model appropriate reactivity to mistakes, and provide video vignettes and examples of both critical and adaptive parenting reactions to mistakes."
15785149|NCT04571801|Diagnostic Test|Standard diagnostics|Only standard diagnostics (Microbial diagnostics by means of standard culture methods) within the first 72 h after diagnosis of sepsis / septic shock
15785150|NCT04571801|Diagnostic Test|Next Generation Sequencing (NGS)|Standard diagnostics + NGS (Microbial diagnostics using standard culture methods + Next Generation Sequencing) within the first 72 h after diagnosis of sepsis / septic shock
15785151|NCT04571788|Procedure|Foldable Capsular Buckle|Intraoperatively, the location and size of the fissure hole is located under the microscope to determine the location and extent of the conjunctival incision. Once local infiltration anesthesia is complete, a 2 ml needle is inserted into the outer surface of the sclera >10 mm behind the corneoscleral rim, and a cotton swab is used to apply light pressure on the side of the wound to help drain the fluid. Under the microscope, the emptied and folded FCB was inserted vertically into the external scleral channel and the drainage valve was sutured with 5.0 non-absorbable sutures 8-10 mm behind the angular scleral rim. The balloon was then filled with 1 ml of alkaline Ringer's solution using a 1 ml syringe through the drainage valve. Subconjunctival injection of tobramycin and dexamethasone was followed by gentle pressure and bandaging of the eye.
15785152|NCT04571788|Procedure|Silicone scleral padding|Intraoperatively, the location and size of the fissure is located under the microscope to determine the location and extent of the incision of the bulbar conjunctiva. When the fissure hole is located microscopically, a retrobulbar block anesthesia is performed and fluid is released according to the degree of retinal detachment. Silicone was then implanted on the scleral surface as an external cushion and intraocular pressure was applied, and the opening was finally sutured, with laser closure performed within a week after surgery. After the surgery, subconjunctival injection of tobramycin and dexamethasone was routinely performed, and the operated eye was bandaged, with observation of the fundus and closure of the aperture.
15785153|NCT04571775|Device|Qi-Shield user group|real device Qi-Shield (treatment)
15785154|NCT04571775|Device|Sham Qi-Shield user group|sham device (placebo)
15785155|NCT04571762|Radiation|Stereotactic Body Radiation Therapy (SBRT)|SBRT (a fraction dose adapted to the OAR geometry-of-the-day, 5 fractions) performed on the MR-Linac
15785156|NCT04571749|Behavioral|Customized handoff|A customized handoff will be implemented that consists of choreographed handoffs utilizing a structured handoff tool to facilitate information exchange.
15785157|NCT04571736|Other|access to the internet information platform|This platform contains, among other things, an explanatory video of thyroid surgery and allows the patient to have access to information on surgical management at any time.
15785158|NCT04571723|Behavioral|Diabetes Prevention Program|This is the established Diabetes prevention program curriculum.
15785163|NCT04571684|Other|HITSystem 2.1|HITSystem 2.1 is an intervention that tracks HIV+ pregnant women and their infants to improve the completeness and efficiency of PMTCT services. Key intervention features include: (1) SMS messages sent to enrolled women and mothers to support essential PMTCT services, (2) automated, algorithm-driven alerts for providers when per-guidelines PMTCT services are missed, and (3) automatic enrollment of infants into early infant diagnosis (EID) and linkage with maternal PMTCT file at documentation of infant birth to improve the continuum of care for HIV+ mothers and HIV-exposed infants. The HITSystem 2.1 intervention aims to facilitate complete PMTCT retention and viral load (VL) monitoring with prompt clinical action (adherence support, antiretroviral therapy (ART) regimen change) in the antenatal, delivery, and 6-month postpartum periods to increase viral suppression during windows critical for HIV prevention.
15785164|NCT04571671|Other|Collect retrospectively data|Analyse the incidence of Mullerian anomalies in these populations
15785165|NCT04571658|Other|Communication|The NEPTUNE Match study includes an interdisciplinary Communication Team that will translate findings from the Molecular Nephrology Board (MNB) to inform patients of the matching assessment with ongoing clinical trials. This team has considerable experience with conveying complex biomedical research information to patients and families and includes experts in precision nephrology, nephrology patient [adult and pediatric] communication, and health education.
15785166|NCT04571645|Drug|Dociparastat sodium|Dociparstat is a glycosaminoglycan derived from porcine heparin.
15785167|NCT04571645|Other|Placebo|0.9% Normal Saline
15785168|NCT04571632|Drug|Avelumab|"Avelumab (200mg/10mL solution) will be administered by intratumoral injection at a maximum total dose of 40 mg (= 2 ml of a 200mg/10ml solution) on day 1 followed by a subsequent intratumoral injections on day 15, 29, 43, 57 and 71.
~Total administered dose of avelumab (200mg/10mL solution) will be up to 2.0 mL per treatment. Injected volume per lesion will range from 0.05 mL for lesions < 0,5 cm to 2.0 mL for lesions > 5 cm in longest diameter.
~Injection of all lesions in individual patients will not be required."
15785169|NCT04571632|Drug|Ipilimumab 5 MG/ML|"Ipilimumab (50mg/10mL solution) will be administered by intratumoral injection at a maximum total dose of 10 mg (= 2 ml of a 50mg/10ml solution) on day 1 followed by a subsequent intratumoral injections on day 15, 29, 43, 57 and 71.
~Total administered dose of ipilimumab (50mg/10mL solution) will be up to 2.0 mL per treatment. Injected volume per lesion will range from 0.05 mL for lesions < 0,5 cm to 2.0 mL for lesions > 5 cm in longest diameter.
~Injection of all lesions in individual patients will not be required. Determination of ipilimumab (50mg/10mL solution) injection volume based on lesion size"
15785170|NCT04571632|Drug|Pembrolizumab 100 MG in 4 ML Injection|The first administration of pembrolizumab 200 mg (100 mg/4mL solution) by the intravenous route during 30 minutes will be administered on day 1. The second administrations of pembrolizumab 200 mg will be administered by a 30 minutes intravenous infusion on day 21, and thereafter every 21 days (or up to ± 3 days before or after the scheduled date if necessary) days.
15785171|NCT04571632|Other|CD1c (BDCA-1)+ / CD141 (BDCA-3)+ myDC|"CD1c (BDCA-1)+ / CD141 (BDCA-3)+ myDC will be administered by intratumoral injection in the lesions that were injected by avelumab en ipilimumab on day 1 (approximately 24 hours after intratumoral injection of avelumab en ipilimumab).
~The total administered CD1c (BDCA-1)+/ CD141 (BDCA-3)+ myDC volume will be up to 4.0 mL per intratumoral treatment session. Injected volume per lesion (skin-, soft tissue or lymph-node metastases) will range from 0.1 mL for lesions < 0,5 cm to 4.0 mL for lesions > 5 cm in longest diameter. Injection of all lesions in an individual patient will not be required.
~The determination of CD1c (BDCA-1)+ / CD141 (BDCA-3)+ myDC injection volume is based on lesion size.
~When lesions are clustered together, they are injected as a single lesion according to the table for determination of CD1c (BDCA-1)+ / CD141 (BDCA-3)+ myDC injection volume based on lesion size."
15785172|NCT04571619|Behavioral|Pain Coping Skills Training (PCST)|The PCST intervention will focus primarily on reducing pain interference in daily activities and improving pain self-management skills. For participants with recent or current opioid use, the PCST intervention will include motivational interviewing aimed at reducing opioid use. During Weeks 1 - 12 the PCST will be delivered by coaches via telehealth (video). During Weeks 13 - 24, the Interactive Voice Response (IVR) will be delivered via telephone. The telehealth component will consist of weekly sessions, each lasting 45-50 minutes. The IVR content, intended to enhance and sustain the effects of the coach-led session, will be delivered with daily telephone interactions, each lasting approximately 5 minutes. Both components of the intervention will be available in English and Spanish.
15785173|NCT04571619|Drug|Buprenorphine|At Week 24, participants who meet the eligibility criteria for the buprenorphine intervention will be randomly assigned, with equal likelihood, to Buprenorphine or No Buprenorphine. Participants randomized to Buprenorphine will be provided with individualized buprenorphine treatment recommendations and encouraged to switch from their full agonist opioid medication to buprenorphine. Individualized buprenorphine treatment recommendations will be made by the study buprenorphine physician based on current opioid use and other relevant factors. Participants randomized to No Buprenorphine will continue to be followed without a pharmacologic study intervention.
15785174|NCT04571606|Procedure|Single injection peripheral nerve block with liposomal bupivacaine (Exparel)|10 mL/133 mg liposomal bupivacaine and 10 mL 0.5% bupivacaine
15785175|NCT04571606|Procedure|Single injection peripheral nerve block with 0.25% bupivacaine and subsequent peripheral nerve catheter with 0.2% bupivacaine infusion via onQ pain pump|20 mL 0.25% bupivacaine block and subsequent 10 mL/hr 0.2% bupivacaine infusion for 48 hours
15785176|NCT04571593|Behavioral|Yoga Nidra|The practice of Yoga Nidra, is a scripted and reproducible, guided meditation technique that promotes mental, emotional and physical relaxation while also facilitating the transition between waking and sleeping.
15785177|NCT04571580|Drug|Saline|intracoronary infusion with saline
15785178|NCT04571580|Drug|Reteplase Injection|low-dose intracoronary fibrinolytic therapy with reteplase 9mg
15785179|NCT04571580|Drug|Reteplase Injection|low-dose intracoronary fibrinolytic therapy with reteplase 18mg
15785180|NCT04571567|Drug|Secukinumab|Each 300mg dose is given as two subcutaneous injections of secukinumab 150mg, 1mg liquid formulation in a pre-filled syringe.
15785182|NCT04571528|Behavioral|TAU + multicomponent treatment VIRTUAL FIBROWALK|Group treatment protocol of 12 weekly 60 minute virtual sessions. All sessions include the following ingredients (approx. in the same order): - Pain neuroscience education (15 min.) - Cognitive restructuring (15 min.) - Mindfulness techniques (15 min.) - Physical exercise(15 min.) - Treatment as Usual (TAU) Standard pharmacological treatment usually provided to patients with fibromyalgia.
15785183|NCT04571528|Behavioral|Treatment as Usual (TAU)|Treatment-as-Usual (TAU) consisted of the prescribed drugs adapted to the symptomatic profile of each patient and basic face to face and written advice on PNE and aerobic exercise adapted to the physical capacities of the patients at the beginning of the study.
15785184|NCT04571528|Behavioral|TAU + Physiotherapy part of VIRTUAL FIBROWALK|Group treatment protocol of 12 weekly 60 minute virtual sessions. All sessions include the following ingredients: - Pain neuroscience education (30 min.) - Physical exercise(30 min.) - Treatment as Usual (TAU). Standard pharmacological treatment usually provided to patients with fibromyalgia.
15785185|NCT04571515|Drug|MR-107A-01|Oral tablet
15785186|NCT04571515|Drug|Placebo|Oral tablet
15785187|NCT04571502|Other|CareHeroes|CareHeroes (CH) is IT that addresses lack of caregiver support and education about ADRD care that often result in depression, burden, and low caregiving self-efficacy. The CH intervention provides caregivers with electronic and video-based educational materials, links to services, and self-assessments for depression and burden that offer feedback. It also allows the caregiver to assess symptoms of the PWD using clinical assessments, which can be shared with the provider. The clinical trial evaluates the impact of the addition of an AAC interface (e-communication board) to CareHereos that relies on touchscreen technology, pictures, and text to support PWD with communication deficits so that the PWD can engage and communicate about preferences and experiences with the caregiver and provider about their daily and clinical care. The minimal intervention group will only have access to a paper version of the AAC.
15785188|NCT04571489|Drug|Gimatecan|Patients will receive gimatecan orally at 0.8mg/m2 on day 1-5 every 4 weeks.
15785189|NCT04571489|Drug|tegafur, gimeracil and oteracil potassium|Patients will receive tegafur, gimeracil and oteracil potassium orally at 40 or 60mg twice daily on days 1 to 14 every 3 weeks.
15785190|NCT04571489|Drug|gemcitabine|Patients will receive gemcitabine IV at 1000mg/m2 on days 1、8 every 3 weeks.
15785191|NCT04571476|Procedure|Ultrathin bronchoscope|Ultrathin bronchoscope (UTB) with an outer diameter no more than 3.0-mm and a 1.7-mm working channel.
15785192|NCT04571476|Procedure|Thin bronchoscope|Thin bronchoscope with a 4.0-mm outer diameter and a 2.0-mm working channel.
15785193|NCT04571476|Procedure|Virtual bronchoscopic navigation combined with endobronchial ultrasound|VBN can create a path to the target lesion automatically when the lesion is depicted in this software.VBN combined with EBUS can improve the diagnostic yield of PPL and shorten the examination time, which has become the standard method for the diagnosis of PPL.
15785194|NCT04571476|Procedure|Guide sheath|GS is a cannula with the thinnest outer diameter of 1.95 mm.
15785195|NCT04571450|Behavioral|Reintervention|This self-applied online program will take three months and comprise 9 behavioural modules developed gradually, achieving the changes needed on eating and physical activity habits, supported by audiovisual instructions given by an hypertension specialist doctor.
15785196|NCT04571437|Drug|Capecitabine|Capecitabine metronomic combined with Letrozole
15785197|NCT04571437|Drug|Letrozole 2.5mg|Letrozole daily alone
15785198|NCT04571424|Drug|BIIB133 (Dapirolizumab pegol)|Administered as specified in the treatment arm
15785199|NCT04571424|Drug|Placebo|Administered as specified in the treatment arm
15785200|NCT04571411|Other|CBC|The aim of this study is to investigate the relationship between severity of envenomation and hematological parameter by detectig initial mean platelet volume (MPV), neutrophil/lymphocyte ratio (NLR) and platelet/lymphocyte ratio (PLR) in pediatric patients presenting with a scorpion sting.
15785201|NCT04571398|Other|ApricityRx mobile application|AE detection and monitoring software
15785202|NCT04571385|Drug|AP30663|Administer by intravenous infusion.
15785203|NCT04571385|Drug|Placebo|Placebo matched to AP30663.
15785204|NCT04571359|Other|Oxalate to creatinine ratio|Comparsion between 24 hours urine oxalate and spot urine oxalate to creatinine ratio
15785205|NCT04571346|Procedure|trans-obturator procedure|TOT procedure will be done using silicon-coated polypropylene tape that will be inserted at the mid-urethral portion. In group 1, a classical vertical vaginal incision will be done proximal to the external urethral meatus with dissection along the axis of the urethra till the mid-urethral zone that is identified by palpating the urethral catheter balloon through the vaginal at the bladder neck, while in group 2, two paramedian incisions will be done 1cm long in the anterior vaginal wall 2 cm apart parallel to the urethra till identification of the mid-urethral portion, communication will be done between the two incisions 1 cm wide in this area creating a tunnel where the tape will be placed, this technique provides healthy tissues proximal and distal to the tape that allows more stabilization and less migration. The rest of the procedure is the same as the standard procedure of Trans-obturator outside-in tension-free technique.
15785206|NCT04571333|Device|Mi2000 Totally Implantable Cochlear Implant|During the surgery visit, the Mi2000 Cochlear Implant will be implanted according to the general surgical guidelines and the Mi2000 specific surgical guidelines under general anaesthesia.
15785207|NCT04571320|Behavioral|Summer STRIPES|See arm description.
15785208|NCT04571320|Other|Enhanced School Services as Usual|see arm description.
15785209|NCT04571307|Procedure|cryotherapy|comparison between cryotherapy and surgery
15785210|NCT04571294|Procedure|removal of para-aortic lymphnodes (PALN)|During pancreaticoduodenectomy, para-aortic lymphnodes (PALN) will be removed for the surgeon
15785211|NCT04571281|Diagnostic Test|capillary lactate measurements|In this study capillary lactate will be measured every 10 minute during CPR.
15785246|NCT04570943|Combination Product|Gabrinox|"Regimen: GEMBRAX
~Other Names:
~Albumin bound paclitaxel 125 mg/m² + Gemcitabine 1000 mg/m²
~Regimen: FOLFIRINOX
~Other Names:
~Oxaliplatin 85 mg/m² + Leucovorin 200 mg/m² + Irinotecan 180 mg/m² + 5FU bolus 400mg/m² + 5FU continuous 2400 mg/m²
~Gembrax + Folfirinox = GABRINOX"
15785278|NCT04570657|Biological|MEDI3506|Participants will receive multiple doses of MEDI3506 at dose level 1 or dose level 2
15785279|NCT04570657|Drug|Placebo|Participants will receive multiple doses of placebo
15785827|NCT04566419|Device|HFNC - Airvo 2|high flow nasal cannulae delivering 60 l/min
15785212|NCT04571255|Behavioral|Music-Assisted Relaxation|The music therapy sessions are based on MAR (Music-Assisted Relaxation), a music therapy technique that includes listening to live music, combined with deep diaphragmatic breathing and/or guided imagery relaxation. In a first step, the procedure will explained to the patient and he/she will be asked to close his/her eyes or focus on a fixed point on the ceiling or wall. Subsequently, a verbal introduction will be provided for fostering body and respiratory awareness. Then a mental image will be introduced (e.g., sitting on a beach watching the waves of the sea; being on top of a mountain looking at the horizon; imagining a safe and comfortable personalized place) and live music will be provided based on the principles of entrainment. The patient is asked to let himself/herself guide by the music and breath with the music while concentrating on the imagery. Once the music is over, the patient is again asked to become aware and the experience during the session will verbally discussed.
15785213|NCT04571242|Device|DTM Programming|DTM-SCS programming
15785214|NCT04571242|Device|Conventional SCS programming|Conventional SCS programming
15785215|NCT04571229|Drug|L-MTP-PE|L-MTP-PE will be administered at a dose of 2mg/m2 (maximum dose 4 mg), twice weekly for 12 weeks and weekly for an additional 24 weeks, for a total of 48 doses in 36 weeks.
15785219|NCT04571203|Biological|Combined Deceased Donor Kidney and Hematopoietic Cell Transplants|This combined kidney and hematopoietic cell transplants with a conditioning regimen with irradiation and ATG creates an environment of immune-tolerance. This promotes hematopoietic cell engraftment.
15785220|NCT04571190|Behavioral|Prenatal MBSR|Prenatal MBSR is an adaptation to the original MBSR program. The essential program elements characterizing MBSR is maintained and integrated with the particular context and specific needs of this group of pregnant women. Adaptations to the MBSR program draw upon both empirical data as well as existing research and theory.
15785221|NCT04571164|Drug|LY03003(Rotigotine,extended-release microspheres)|During the intervention, the initial dose was 14mg, and then was incremented in weekly units, 14mg each time, until the maximum dose of 56mg set in this study was reached 4 weeks after titration, the optimal therapeutic dose or the maximum tolerated dose was entered into the dosing maintenance period. After entering the maintenance period, no dose adjustment was performed, and the stable dose was maintained for 24 weeks
15785222|NCT04571164|Drug|Placebo,extended-release microspheres|During the intervention,the initial does was 14mg,and then was incremented in weekly units,14mg each time,until the maximum does of 56mg set in this study was reached 4 weeks after titration,the optimal therapeutic does or the maximum tolerated does was entered into the dosing maintenance period.After entering the maintenance period,no does adjustment was performed,and the stable does was maintained for 24 weeks.
15785223|NCT04571151|Drug|LEXETTE 0.05% Topical Foam|Halobetasol Propionate Topical Foam (Lexette Foam) would be applied over the affected area twice daily for 2 weeks.
15785224|NCT04571151|Drug|Sorilux 0.005 % Topical Foam|Calcipotriol Foam (Sorilux Foam) would be applied over the affected area twice daily for 2 weeks 5 minutes after the Lexette application. SORILUX Foam contains calcipotriene 50 mcg/g.
15785225|NCT04571151|Other|Vehicle Foam|Vehicle Foam would be applied over the affected area twice daily for 6 weeks.
15785226|NCT04571138|Biological|SCRI-CAR22v2|Single infusion of SCRI-CAR22v2
15785227|NCT04571112|Device|NBM stimulation using the Vercise device (Boston Scientific, Marlborough, Massachusetts, US)|This will either be turned on or off depending on the arm which the patient is randomized to. After 8-weeks, the subject will switch arms for another 8-weeks.
15785228|NCT04571073|Procedure|Fascial Distortion Model|"Using physical exam and manual manipulation skills informed by the FDM, he identified and treated locations of presumed fascial distortion about the plantar area of the foot; distortions could include any of the six reported fascial anomalies in the FDM: continuum distortions, trigger bands, herniated trigger points, folding distortions, cylinder distortions, and tectonic fixations. Each distortion is associated with a recommended reparative manipulation. The purported mechanism of action is that the distortion-specific manipulation restores normal fascial homogeneity."
15785231|NCT04571047|Other|Time to treatment|Treatment before or after 4 weeks after diagnosis
15785232|NCT04571034|Procedure|Sham Therapeutic Ultrasound|A standard ultrasound machine (Vectratm by Chattanooga Group, Inc.) with inactive probe will be used to deliver sham massage.
15785233|NCT04571034|Procedure|Medium-Intensity Roller Massage|This group will receive a single bout of roller massage at medium intensity (25 newtons of force directed perpendicular to the surface of the thigh).
15785234|NCT04571034|Procedure|High-Intensity Roller Massage|This group will receive a single bout of roller massage at medium intensity (45 newtons of force directed perpendicular to the surface of the thigh).
15785235|NCT04571021|Other|I-DEPT|Implementation of the novel triage algorithm
15785236|NCT04571021|Other|DEPT|Existing triage algorithm
15785237|NCT04571008|Other|Placebo|Intervention will last at least 16 weeks in the form of two capsules.
15785238|NCT04571008|Dietary Supplement|Treatment|Intervention will last at least 16 weeks in the form of two NMN capsules (total of 300 mg/day).
15785239|NCT04570995|Dietary Supplement|Fish Oil|Dietary supplement containing fish oil, encapsulated in soft gel capsules, given 5 days per week
15785240|NCT04570995|Dietary Supplement|Safflower Oil|Dietary supplement containing a placebo oil product (safflower oil), encapsulated in soft gel capsules, given 5 days per week
15785241|NCT04570982|Biological|Convalescent Plasma|The objective of this protocol is to provide a coordinated approach for distribution and guidance for safe and effective administration of convalescent serum with antibodies against SAR CoV-2 for treatment of patients with COVID-19 infection who are most likely to benefit from this investigational treatment and monitor them.
15785242|NCT04570969|Procedure|Erector spinae plane block|Insertion of bilateral catheters in the intersfacia space of erector spinae muscle
15785243|NCT04570956|Drug|Tamoxifen|Oral Tamoxifen 10 mg/day
15785244|NCT04570956|Drug|Topical 4-OHT( 4-hydroxytamoxifen)gel 2 mg/each breast/day|Topical 4-OHT (4-hydroxytamoxifen) gel 2 mg/each breast/day
15785245|NCT04570956|Drug|Placebo|placebo pill or placebo gel
15785247|NCT04570943|Radiation|MRI-GUIDED STEREOTACTIC RADIOTHERAPY|"Radiotherapy will start between 5 and 6 weeks after the last injection of chemotherapy (FOLFIRINOX regimen) in non-progressive patients after Gabrinox.
~Stereotactic adaptive radiotherapy in five fractions: prescription of five fractions of 10 Gy/each on the planning target volume (PTV). At least two sessions/week should be performed. An interval of at least 18 hours between fractions is recommended."
15785248|NCT04570930|Behavioral|Just-in-time adaptive intervention (JITAI)|JITAI is an emerging intervention that incorporates passive mobile sensor data feedback (sleep and activity [step] data from a Fitbit ®), and real-time self-reporting of HRQOL via a study specific app called CareQOL to provide personalized feedback via app alert.
15785249|NCT04570930|Behavioral|Control|Participants will wear the Fitbit® and provide daily reports of HRQOL over a six-month (180 day) period.
15785250|NCT04570917|Behavioral|Online educational intervention to reduce ageism|Participants in this group will go over multiple short videos covering the following content:1). Myths about aging, 2). Ageism and its negative effects, 3). Distorted views about aging among young adults, 4). Ageism during the COVID-19 pandemic, and 5). importance of reducing ageism among healthcare professionals. These will be multiple videos posted on the LMS (Blackboard). At the end of the lesson, they will be asked to briefly write what they learned on Blackboard as an assignment.
15785251|NCT04570917|Behavioral|Online educational intervention to enhance cultural competance|Participants in the control group will go over multiple short videos covering the following content: 1). Myths about cultural competence, 2) Cultural competence for health care professionals including dietitians, 3). Connecting culture and food, and 4). Importance of cultural competence in sports dietitians. At the end of the lesson, they will be asked to briefly write what they learned. These will be multiple videos posted on the LMS (Blackboard). At the end of the lesson, they will be asked to briefly write what they learned on Blackboard as an assignment.
15785252|NCT04570904|Biological|Influenza vaccination at different time points|All HCWs will receive the seasonal influenza vaccine but at two different time points.
15785253|NCT04570891|Procedure|Ultrasound-guided fascia iliaca compartment block|Ultrasound-guided fascia iliaca compartment block (0.25% ropivacaine 1mL/kg, Max 30mL) will be provided at the end of surgery.
15785254|NCT04570891|Procedure|Control|No regional block is provided at the end of surgery.
15785255|NCT04570878|Procedure|SC TAP|Bilateral subcostal transverse abdominis plane block will be performed using 0.25% ropivacaine (0.5mL/kg for each side, MAX 20mL for each side) under ultrasound-guidance at the end of surgery.
15785256|NCT04570878|Procedure|Control|No regional block is provided at the end of surgery.
15785257|NCT04570865|Drug|Dapagliflozin|The focus of this study is to investigate the use of Dapagliflozin in HFrEF (NYHA II-IV) patients with or without diabetes who have CardioMEMS® implanted to assess the impact on pulmonary artery pressure measurements after 12 weeks of therapy.
15785258|NCT04570865|Device|CardioMEMS|The focus of this study is to investigate the use of Dapagliflozin in HFrEF (NYHA II-IV) patients with or without diabetes who have CardioMEMS® implanted to assess the impact on pulmonary artery pressure measurements after 12 weeks of therapy.
15785259|NCT04570852|Other|LiDCO|"We plan to elucidate the pathophysiology and molecular subtypes of acute pancreatitis in order to develop specific biomarkers and identify new drug targets. The evaluation will include an analysis of the impact of obesity and the metabolic profile during the disease course of acute pancreatitis.
~Supportive treatments will be registered including an assessment of the fluid balance based on the fluid intake and loss and weight. Bioimpedance will be assessed at admission/day1, day 2, day 3,"
15785260|NCT04570839|Drug|COM701 in combination with BMS-986207 and nivolumab.|Study treatment with the 3 drug combination (COM701 in combination with BMS-986207 and nivolumab).
15785261|NCT04570826|Other|Meditation.|The caregivers received eight sessions lasting each one two hours with the following sequence: before each practical exercises they always received 15 minutes about scientific theoretical evidence explaining the importance of doing them: to get a comfortable posture they received 25 minutes of mobility, flexibility, balance, strength and endurance exercises. To increase lung capacity, 25 minutes of costal, diaphragmatic and clavicular breathing exercises. Finally, to have an open attitude without distractions or judging they practiced 25 minutes of body awareness exercise observing sensations, thoughts and perceptions with gratitude and compassion.
15785262|NCT04570826|Other|Scientific descriptions about meditation.|The control group received scientific descriptions about meditation.
15785263|NCT04570813|Other|Artistic activies|12 workshops of artictic activities during 12 weeks
15785264|NCT04570787|Procedure|Urinary bladder catheterisation|Installation of Foley catheter into the urinary bladder
15785265|NCT04570774|Procedure|Repetitive transcranial magnetic stimulation|rTMS over cerebral motor cortex and cerebellar hemisphere
15785266|NCT04570761|Device|Dreem headband|acoustic stimulation
15785267|NCT04570761|Device|Dreem headband|acoustic stimulation
15785268|NCT04570748|Procedure|Capsule repair|Direct anterior hip arthroplasty with or without capsule repair
15785269|NCT04570748|Procedure|capsulectomy|capsulectomy without repair
15785270|NCT04570735|Diagnostic Test|MRI|MRI
15785271|NCT04570722|Other|Ipsilateral peripheral IV insertion|Patients with successful ipsilateral intravenous access will be provided a patient education sheet describing signs and symptoms that should be reported to the study team. All participants will be contacted by the study team at twelve week intervals for 12 months after their radiology encounter for completion of symptom assessments. If a subject reports new signs or symptoms of lymphedema during follow-up, a clinic appointment for volumetric measurements and thorough evaluation will occur
15785272|NCT04570709|Other|Palliative And supportive Care inTervention (ACT)|Using the Adaptive Leadership Framework for Chronic Illness as a guide. RN will complete a symptom assessment within 2 days of patient admission and will continue to monitor patient's symptoms daily throughout hospitalization. OT, PT, project staff will assess and monitor function and physical health status within 2 days of patient admission and will continue to monitor patient's symptoms. Collaborating with patient, RN, OT, and PT will identify and monitor symptoms. RN, OT, PT, and patient will meet to exchange information and develop a shared understanding. RN, OT, and PT will also address technical challenges. PACT team and patient will use the shared understanding of adaptive challenges to find creative ways to do the adaptive work to reduce the impact of symptoms, function, and physical health. Finally, patient and PACT team will establish SMART goals, which are reassessed twice weekly.
15785273|NCT04570696|Other|NON INTERVENTIONAL|NON INTERVENTIONAL
15785280|NCT04570644|Drug|ALZT-OP1 (cromolyn and ibuprofen) ALZT-OP1a (cromolyn) and ALZT-OP1b (ibuprofen)|"Drug : ALZT-OP1a
~Mast cell stabilizer
~Neuroinflammatory microglial modulator
~ALZT-OP1b anti-inflammatory
~Device: Dry Powder Inhaler The inhaler will be used to deliver ALZT-OP1a via oral inhalation for dosing on study."
15785281|NCT04570631|Drug|Eftozanermin alfa|Intravenous (IV) infusion
15785282|NCT04570631|Drug|Bortezomib|Intravenous (IV) or Subcutaneous (SC) injection
15785283|NCT04570631|Drug|Dexamethasone|Oral Tablet
15785284|NCT04570618|Device|Unblinded AlgoDx Sepsis Prediction Algorithm|When applicable, a sepsis prediction alert is displayed in the AlgoDx Medical Device Software.
15785285|NCT04570618|Other|Blinded AlgoDx Sepsis Prediction Algorithm|Standard of Care, i.e. no sepsis prediction alert.
15785286|NCT04570605|Device|parasacral transcutaneous electrical nerve stimulation (PTENS)|electrode patches placed on skin of lower back just above each side of the gluteal cleft (parasacral) and attached to TENS unit at specific settings three times a week for 30 minutes for 12 weeks.
15785287|NCT04570605|Other|Standard Urotherapy|standard behavioral therapy recommendations including timed voiding, fluid intake recommendations and bowel management recommendations including videos instructing patients and parents on these issues. This is current standard of care.
15785288|NCT04570592|Drug|Granisetron 1 Mg/mL Intravenous Solution And Dexamethasone 4mg|Comparing PONV incidences in both arms
15785289|NCT04570592|Drug|Granisetron 1 Mg/mL Intravenous Solution|Comparing PONV incidences in both arms
15785290|NCT04570579|Device|Vivity Extended Depth of Focus Intraocular Lens|Patients selected to have bilateral sequential cataract surgery using the Vivity (spherical and/or toric where applicable) intraocular lens implant will subsequently be offered enrollment into this observational study. Visual outcomes will be recorded at postoperative day 1, week 1, month 1 and month 3.
15785291|NCT04570566|Procedure|horizontal alveolar ridge augmentation|evaluate the potential application of resorbable pericardium membrane to augment localized alveolar ridge defects in esthetic zone, from histological, radiographical and clinical aspects in comparison with titanium mish for the subsequent placement of dental implants
15785292|NCT04570553|Procedure|surgical staging|Patients will undergo standard surgical staging for endometrial cancer utilizing either a V-care uterine manipulator or sponge stick
15785293|NCT04570540|Diagnostic Test|Sleep Study|Full-night attended in-lab polysomnography with accompanying transcutaneous capnometry
15785294|NCT04570540|Diagnostic Test|Pulmonary Function Test|Bodyplethysmographic assessment
15785295|NCT04570540|Diagnostic Test|Hypercapnic ventilatory response|Measurement of hypercapnic ventilatory response based on the method described by Read in 1967, using a rebreathing bag
15785296|NCT04570540|Diagnostic Test|Cardiopulmonary Exercise Test|Symptom-limited cardiopulmonary exercise test with a ramp protocol according to the ATS/ACCP and ERS recommendations
15785297|NCT04570527|Procedure|PCI|percutaneous coronary intervention
15785298|NCT04570514|Procedure|PCI|percutaneous coronary intervention (PCI)
15785299|NCT04570501|Drug|Angiotensin-(1-7)|Ang (1-7) administered by continuous intravenous (IV) infusion
15785300|NCT04570501|Drug|Placebo|Placebo (normal saline) administered by continuous intravenous (IV) infusion
15785301|NCT04570488|Other|EPIC risk score display|Display of risk score/ colored flag in Epic patient list column
15785302|NCT04570475|Drug|Vitamin D|Participants will receive vitamin D+multivitamin for 3 weeks. At the end of 3 weeks they will complete an online or paper questionnaire and blood work will be done.
15785303|NCT04570475|Drug|multivitamin|Participants will receive placebo+multivitamin or vitamin D+multivitamin for 3 weeks. At the end of 3 weeks they will complete an online or paper questionnaire and blood work will be done.
15785304|NCT04570475|Drug|Placebo|Participants will receive placebo+multivitamin for 3 weeks. At the end of 3 weeks they will complete an online or paper questionnaire and blood work will be done.
15785305|NCT04570462|Other|Hypothermia Via Cooling Machine- Arctic Sun 5000|"Initiate hypothermia using the Arctic Sun.The Arctic Sun 5000® is set to a temperature of 34.5 C to lower the body temperature.
~Duration of hypothermia will be 48 hours after which the subject will be rewarmed. Metabolic rate, or indirect Calorimetry, will be assessed at baseline, day 1 of hypothermia, day 2 of hypothermia before rewarming, and after full rewarming. CBC, basic metabolic profile, magnesium, phosphorus, coagulation profile, ABG, inflammatory markers would be drawn every 12 hours during hypothermia until subject has achieved full rewarming and once after full rewarming.
~The entire hypothermia procedure will last 48 hours. Acceptable rewarming range is a temperature of 36.5C to 37.5C. The subject body temperature rewarming is typically set over 6-8 hours. Therefore, the final 6-8 hours of the 48 hour time period is set to rewarm the subject."
15785306|NCT04570449|Drug|Fluoxetine|20 mg capsule
15785307|NCT04570449|Drug|Placebo|fluoxetine placebo capsule
15785308|NCT04570436|Drug|gabapentin 600 mg|participants will receive an oral dose of gabapentin 600 mg
15785309|NCT04570436|Drug|gabapentin 1200 mg|participants will receive an oral dose of gabapentin 1200 mg
15785310|NCT04570436|Drug|gabapentin 1800 mg|participants will receive an oral dose of gabapentin 1800 mg
15785311|NCT04570436|Drug|diazepam 20 mg|participants will receive an oral dose of 20 mg dose of diazepam
15785312|NCT04570436|Other|placebo|participants will receive an oral dose of placebo
15785313|NCT04570423|Drug|Eflapegrastim|Eflapegrastim supplied in prefilled, single-use syringes for SC injection.
15785314|NCT04570423|Drug|Chemotherapy|Chemotherapy agents may include doxorubicin, ifosfamide, docetaxel, CHOP regimen, etoposide, cyclophosphamide and vincristine which will be administered as per standard of care per the Primary Care physician's treatment plan.
15785315|NCT04570410|Procedure|primary focal resection plus lymph node dissection|Primary radical resection plus lymph node dissection was performed in patients with oligometastatic urothelial carcinoma
15785316|NCT04570410|Drug|Tislelizumab|Tislelizumab IV infusion of 200 mg Q3W
15785317|NCT04570410|Drug|Gemcitabine plus cisplatin|GC (Gemcitabine plus cisplatin): Gemcitabine 1000mg/m2 D1,D8 iv every 3 weeks Cisplatin70mg/m2,D2,3,4 iv every 3 weeks
15785318|NCT04570397|Drug|Ravulizumab|Patients will receive weight-based dosing of ravulizumab on Days 1, 5, 10, and 15 along with the standard care.
15785319|NCT04570384|Drug|L-Citrulline|L-Citrulline (Turnobi) for Injection. Patients will receive an initial bolus of 20 mg/kg (maximum 1500 mg), followed by study infusion of 9 mg/kg per hour (maximum 700mg) for up to 10 days.
15785320|NCT04570384|Drug|Placebo|Patients randomized to placebo will receive equal volume bolus and study infusion of 5% dextrose water for a maximum of 10 days.
15785321|NCT04570371|Behavioral|Conversation Guide + Clinical Support|The intervention is a bundled intervention (conversation guide + clinician decision support tools) which promotes the solicitation and use of patient preferences for post-surgical, non-pharmacological pain management strategies.
15785322|NCT04570358|Other|Static stretching|During the static stretching training for the calf muscles, the ankle joint is moved into maximal dorsiflexion until the point of discomfort is reached. The ankle joint is then held in this maximal position for 30 s followed by a rest period of 30 s. Afterwards, the procedure is repeated with the knee in flexed position to stretch the soleus muscle.
15785323|NCT04570358|Other|Proprioceptive neuromuscular facilitation stretching|During the proprioceptive neuromuscular facilitation stretching, the ankle joint is moved into maximal dorsiflexion. While the foot is kept in this position, the child will perform a (sub-) maximal isometric contraction of the plantar flexors against the resistance of their parents. Afterwards, the ankle joint will be moved further into greater dorsiflexion and is held there for the remaining seconds followed by 30 s of rest. Subsequently, the stretch will be applied with the knee flexed.
15785324|NCT04570345|Drug|ticagrelor monotherapy|• Drug: ticagrelor monothearpy after first 3 months dual therapy
15785325|NCT04570345|Drug|Aspirin with P2Y12 receptor inhibitor|• Drug: aspirin plus ticagrelor dual therapy during 12 months
15785326|NCT04570332|Drug|BO-112 and Pembrolizumab|Patients will be treated with the combination of BO-112 and pembrolizumab. Order of administration should be pembrolizumab then IT BO-112. BO-112 will be administered IT at a total dose of 1-2 mg at each administration to 1-8 tumor lesions using tuberculin (TB) syringes (or equivalent) with 20- to 23-gauge needles
15785327|NCT04570332|Procedure|Tissue Biopsies|Pre and post (if feasible) treatment tumor tissue biopsies will be used for correlative research.
15785328|NCT04570319|Dietary Supplement|Probiotic Bths-08|A capsule containing the probiotic blend (dietary supplement), administered once daily for 12 weeks
15785329|NCT04570319|Dietary Supplement|Placebo|A capsule containing the placebo (dietary supplement), administered one daily for 12 weeks
15785330|NCT04570306|Drug|Belimumab|The study will involve 80 adult patients diagnosed with SLE who will be started on belimumab (standard approved dose of i.v. 10 mg/kg or subcutaneous 200 mg/week) due to active disease. The intention to start belimumab will be made by the treating Rheumatologist(s), in accordance to the current standard of care, and on the basis of shared physician-patient decision making.
15785331|NCT04570293|Drug|5% lidocaine medicated plaster|The 5% lidocaine medicated plaster is measuring 10 cm x 14 cm contains 700 mg lidocaine (5% w/w) For each patient, the painful area and the trigger point will be chosen for treatment. The investigator will instruct the patient to replace the patch every 12 hours. The patches could be applied during the night (application in the evening and removal in the morning), or during the day. Patients will be told to apply up to three patches at one time.
15785332|NCT04570293|Drug|vehicle plaster|Vehicle patches are identical to the active patch, except for the absence of lidocaine, without any optical differences.For each patient, the painful area and the trigger point will be chosen for treatment. The investigator will instruct the patient to replace the patch every 12 hours. The patches could be applied during the night (application in the evening and removal in the morning), or during the day. Patients will be told to apply up to three patches at one time.
15785333|NCT04570280|Other|Aerobic Exercises|Aerobic exercises with treadmill will be applied 3 times a week for 12 weeks.
15785334|NCT04570280|Other|Resistive Exercises|Resistive exercises with sandbag will be applied 3 times a week for 12 weeks.
15785335|NCT04570280|Other|Range of Motion Exercises|Range of Motion Exercises will be applied 3 times a week for 12 weeks.
15785336|NCT04570267|Biological|CSL324|Sterile solution of recombinant anti G-CSF receptor monoclonal antibody for injection
15785337|NCT04570267|Drug|Placebo|Sterile solution of CSL324 formulation buffer for injection
15785338|NCT04570254|Drug|Vitamin C|Vitamin C. Tablet of 1 gr. A dose of 1 gr every 12 hours. Dissolve one tablet in a volume of 30 ml of water and administer it immediately, then rinse the glass with 10 ml of water and administer it to the patient. Protect from light at all times, as it is photosensitive.
15785339|NCT04570254|Drug|Vitamin E|Vitamin E. 800 mg tablet. 800 mg dose every 24 hours. Dissolve the capsule in 30 ml of hot water. The administration of vitamin E is recommended during or after meals since its absorption depends on pancreatic enzymes' presence.
15785340|NCT04570254|Drug|Melatonin|"Melatonin Tablet 5 mg. A dose of 50 mg every 24 hours. Grind the 10 5 mg melatonin tablets (50 mg), levitate with 50 mL of Ora-plus (Transferring to a beaker with a magnetic stirrer). Maintain gentle agitation. Rinse the mortar with 10 mL of Ora-sweet. Add 30 mL of Ora sweet to the glass where the mixture is being made. Makeup with Ora-sweet cbp 100 mL Place label FL02 with legend Melatonin 50 mg / 20 mL. Protected from light (Dispense in a black bag that covers the transparent bag of the preparation)'s primary packaging) Give after breakfast."
15785341|NCT04570254|Drug|N-acetyl cysteine|N-acetylcysteine. Tablets, 600 mg. 600 mg dose every 12 hours. Dissolve one tablet in a volume of 30 ml of water and administer it immediately, then rinse the glass with 10 ml of water and administer it to the patient.
15785342|NCT04570254|Drug|Pentoxifylline|Pentoxifylline. 400 mg tablets. 400 mg dose every 12 hours. The tablet is dissolved in 30 ml of water and is administered orally or nasogastric tube.
15785343|NCT04570241|Behavioral|Malaria toolkit|Knowledge, attitude, and practice on malaria
15785344|NCT04570228|Device|Pulmonary artery denervation|The TIVUS system will be used for pulmonary artery denervation using non focused ultrasound
15785345|NCT04570228|Device|Sham procedure|A sham procedure would be performed using the TIVUS system without delivering the non focused ultrasound
15785346|NCT04570215|Other|Gotcha! Therapy application|"Gotcha! will provide an app-based therapy for people with dementia who have difficulty naming people they know well.
~The therapy element works via mass practice and feedback to the users on a trial-by-trial basis. The DNI is very simple in a way; it just presents a long series of pictures for users to name. This DNI will use speech recognition (SR) software in order to make a binary decision as to whether the user said the correct word or not. This affects what the next trial (object to name) is and what auditory cue (if any) is provided the next time the user has to name the same item."
15785347|NCT04570215|Other|Gotcha Therapy application: Maintenance|Gotcha! Maintenance therapy is identical to Gotcha! but takes place over a longer period of time in an attenuated form.
15785348|NCT04570202|Behavioral|EMDR|The EMDR therapy is organized in eight different phases, requiring attending multiple sessions, usually 12 separate sessions.
15785349|NCT04570189|Device|Auscul-X|The Auscul-X System (AusculSciences Canada, Inc.), is novel, professional grade, touch free, multichannel, touch-free electronic stethoscope with disposable elements designed to protect HCPs from exposure to infection diseases by allowing them to auscultate patients from a safe distance (10 feet away). The sensors can stay in place and enable providers to listen on-demand to a patient's heart and lungs over an extended period of time. This practice of distancing in the workplace is a key CDC and PHAC recommendation to protect the frontline HCP from exposure risk to the highly contagious COVID- 19 virus and other communicable diseases. The Auscul-X not only has the potential to better protect HCPs from infection, but also eliminates the potential transmission of pathogens through the use of conventional stethoscopes. In addition, the Auscul-X allows multiple HCPs to listen to the patient's heart and lung sounds simultaneously
15785350|NCT04570176|Procedure|adrenalectomy for adrenal adenoma|adrenalectomy， cystectomy and nephrectomy
15785351|NCT04570163|Device|Interventional therapy mainly of tricuspid regurgitation (TriClip, Cardioband)|Catheter-based therapy of valve diseases of the right heart with various devices (e. g. TriClip, Cardioband).
15785352|NCT04570150|Drug|Sugammadex|Subjects who are randomized to into the sugammadex arm (Arm I) will receive sugammadex for reversal of neuromuscular block at the completion of their anesthetic; Outcomes measures will be recorded and compared with those from Arm II (neostigmine group).
15785353|NCT04570150|Drug|Neostigmine|Subjects who are randomized into the neostigmine arm (Arm II) will receive neostigmine for reversal of neuromuscular block at the completion of their anesthetic; Outcomes measures will be recorded and compared with those from Arm I (sugammadex group).
15785354|NCT04570137|Dietary Supplement|Dietary fiber supplementation|"16g/day: mix of 70% wheat-bran arabinoxylan and 30% oat-derived fiber (ß-glucan)
~16g/day: mix of 50% inulin and 50% oligofructose from chicory"
15785355|NCT04570124|Device|Home Blood Pressure Telemonitoring|Women will complete a 9-question survey (pre-education) prior to discharge and will go over an education video a study team member. Once discharged, women will be asked to measure their blood pressure daily for the first postpartum week, and then weekly until postpartum week 6. Women who have a doctor's visit scheduled during the first 10 days, a member of the study team will meet them there to assess blood pressure and answer any questions. Women who do not have a visit scheduled they will have a telehealth visit during days 8-10 to complete the same assessments. At the final visit, participants will measure their blood pressure via HBPT, prior to returning the unit, complete a post-education questionnaire, a post-study questionnaire and have any questions or concerns addressed.
15785356|NCT04570111|Other|MOD Diet|The macro-optimized diet alters the timing of macronutrient intake to provide fewer carbohydrates at breakfast, while maintaining recommended amounts of macronutrients delivered throughout the course of the day
15785357|NCT04570111|Other|Standard Care Diet|The standard care diet provides macronutrients within standard amounts (40% carbohydrate, 20% protein, 40% fat) at all meals and snacks per day.
15785358|NCT04570085|Drug|Caffeine|100mg caffeine capsule treatment, beginning after caffeine diet during 6 weeks, titrate in 3 weeks (by 100mg stages) until 400mg aim dose per day in 2 doses during 27 weeks, and finally interrupt according to the same negative titration.
15785359|NCT04570085|Drug|Placebo|Placebo capsule treatment, beginning after caffeine diet during 6 weeks, titrate in 3 weeks until 2 doses aim dose per day during 27 weeks, and finally interrupt according to the same negative titration.
15785360|NCT04570072|Dietary Supplement|Probiotic|Patients receive the formula probiotic for consecutive 8 weeks ( one sachet per day ).
15785361|NCT04570072|Dietary Supplement|Placebo|Patients receive the placebo identical to probiotic for consecutive 8 weeks ( one sachet per day ).
15785362|NCT04570059|Behavioral|Counselling on textured food introduction between 8 and 15 months|"Intervention program : Advice and tips on the why and how introducing textured food during complementary feeding are grouped in a booklet and provided to participants. Monthly counselling via phone call by a dietician (at 9, 10, 11,12, 13, 14 months) and two baskets containing food preparation utensils and commercial textured foods provided at 8 and 12 months.
~Usual care : reflects the standard information provided within French national guidelines (PNNS). Two phone calls at 9 and 13 months. If questions are raised by parents, dieticians will restrict their responses based on the food guides of the PNNS. Two gift boxes containing presents for the child of same financial value as those provided to intervention group, provided at 8 and 12 months."
15785363|NCT04570033|Diagnostic Test|We assessed sensitivity of 18F-FCH PET/CT in preoperative localisation of hyperfunctioning parathyroid tissue in patients with primary hyperparathyroidism|We prospectively enrolled 65 consecutive patients with PHPT who underwent neck ultrasound (US) and parathyroid scintigraphy (99mTc/99mTc-MIBI dual phase). Twenty-two patients had unsuccessful parathyroid surgery prior to the study. PET/CT scans were performed 65.0 ± 13.3 min after injection of 218.5 ± 31.9 MBq of 18F-fluorocholine (FCH). Three experienced nuclear medicine physicians assessed the detection rate of hyperfunctioning parathyroid tissue. Response to parathyroidectomy and clinical follow-up served as a reference test. Per-patient sensitivity and positive predictive value (PPV) were calculated for patients who underwent surgery.
15785365|NCT04569994|Drug|NNC0363-0845|A single dose administered s.c. (subcutaneously, under the skin)
15785366|NCT04569994|Drug|Placebo (NNC0363-0845)|A single dose administered s.c.
15785367|NCT04569994|Drug|Insulin degludec|A single dose administered s.c.
15785368|NCT04569981|Other|Climbing|The patients in the Climbing Group (CG) followed a 12-weeks long climbing trainings course in small groups of 3-4 participants with a certified climbing instructor.
15785369|NCT04569981|Other|Unsupervised activity group|The patients in the unsupervised activity group (UAG) received education European physiotherapy guidelines for physical activity recommended by the WHO of recommended activity and followed their self-selected activities over 12 weeks.
15785370|NCT04569968|Other|Expiratory muscle training|For training group first maximum expiratory pressure measurement will be assessed with portable expiratory measurement device. Measurement will be taken while the patient in a sitting position. Three measurement values with 5% variation will be taken an average of these values recorded as a maximum expiratory pressure of the patient. After the maximum expiratory pressure of the patient is measured 50% percent of the related value will be set on the expiratory muscle trainer. Then patient will be informed about how to use the trainer. Trainer will be used daily for four weeks with 50 repetitions. At the end of every week pressures will be measured again for re-calibration of the trainer.
15785371|NCT04569955|Behavioral|Knowledge and perception of clinical trial participation|This study aims to get a current picture of the patients' knowledge and perception of clinical trial participation in Breast cancer female patients in Egypt, as an example to Low/Middle income countries
15785372|NCT04569942|Drug|Vasopressor|Cease IV fluid resuscitation. If persisting hypotension and/or hypoperfusion commence a vasopressor infusion (e.g. noradrenaline) and titrate according to local practice to achieve target MAP. The target MAP will be determined by the treating clinician. Reassess at least hourly for up to 6 hours post-randomisation, then as clinically required in conjunction with the protocol. Boluses of 250ml of IV fluids are permitted if deemed indicated by the treating clinician.
15785373|NCT04569942|Other|Fluids|An fluid bolus of up to 1000ml will be administered over a maximum of 1 hour, if required, for persisting hypotension and/or hypoperfusion. Reassess at least hourly to 6 hours post-randomisation, then as clinically required in conjunction with the protocol. Further IV fluid boluses of 500ml are recommended as clinically indicated to achieve the target MAP. The target MAP will be determined by the treating clinician. Haemodynamic resuscitation will be guided by usual clinical assessment including vital signs, mentation, perfusion, and urine output until the treating clinician determines fluid resuscitation is no longer clinically required. A minimum of 2-3 L (30 ml/kg), including pre-randomisation fluids, is recommended within 3 hours of ED arrival consistent with the SSC guidelines, unless clinically contraindicated. Vasopressors may be commenced if blood pressure remains below target despite optimal fluid resuscitation as determined by the treating clinician.
15785374|NCT04569929|Other|(DLP)-printed photo-polymerizable PMMA Nextdent mandibular implant overdenture|The bite registration records with their corresponding master casts were digitalized using an extra oral desktop 3D scanner (3shape D850) and then stored as standard triangulation language (STL) files (Figure 1). The STL files were then imported to Dental system PREMIUM3 design software (3Shape Dental System 2018) for model analysis, surveying and blocking out, designing full permanent denture bases, and for virtual teeth set-up following the recorded inter-arch space
15785375|NCT04569916|Radiation|radiotherapy|radiotherapy combined with irinotecan liposome and apatinib followed by PD-1 antibody and apatinib
15785376|NCT04569916|Drug|irinotecan liposome|radiotherapy combined with irinotecan liposome and apatinib followed by PD-1 antibody and apatinib
15785377|NCT04569916|Drug|apatinib|radiotherapy combined with irinotecan liposome and apatinib followed by PD-1 antibody and apatinib
15785378|NCT04569916|Drug|PD-1 antibody|radiotherapy combined with irinotecan liposome and apatinib followed by PD-1 antibody and apatinib
15785379|NCT04569903|Device|Computer algorithm for ATTR|Patients will be evaluated for the identification of ATTR Amyloidosis through a claims-based algorithm
15785380|NCT04569890|Drug|Certolizumab Pegol 200 MG/ML [Cimzia]|CZP 200mg twice a week subcutaneous.
15785381|NCT04569890|Drug|Hydroxychloroquine|400mg HCQ orally daily
15785382|NCT04569890|Drug|Prednisone|10mg GC orally daily
15785383|NCT04569877|Drug|Molgramostim nebuliser solution|300μg molgramostim nebuliser solution nebulised seven times within 7 days via rapid nebuliser system
15785384|NCT04569877|Other|Placebo nebuliser solution|Placebo nebulised seven times within 7 days via rapid nebuliser system
15785385|NCT04569864|Procedure|Hypothermic circulatory arrest with unilateral selective anterograde cerebral perfusion|Hypothermic circulatory arrest provides protection to cerebral and visceral organs.
15785386|NCT04569838|Drug|Bendamustine hydrochloride injection|Bendamustine is a bifunctional alkylating agent. It cross-links DNA single strand and double strand by alkylation,then destroys the function and synthesis of DNA, and makes the DNA and protein, protein and protein cross-linking, has potential to treat various tumors
15785387|NCT04569825|Drug|Ophtamesone|local application intranasally as drops
15785388|NCT04569812|Procedure|Cardiopulmonary Resuscitation|flowchart-assisted standard resuscitation or chest compressions-only resuscitation for 5min
15785390|NCT04569786|Biological|V590|Single dose of V590 administered via intramuscular (IM) injection with dosage levels of 5.00x10⁵ pfu/mL (Panels A, E), 2.40x10⁶ pfu/mL (Panels B, F), 1.15x10⁷ pfu/mL (Panels C, G), 5.55x10⁷ pfu/mL (Panels D, H, I).
15785391|NCT04569786|Other|Placebo|Placebo administered via IM injection.
15785392|NCT04569773|Behavioral|Impact of Event Scale-Revised|The IES-R is a validated 22-item self-report scale measuring psychological stress reactions after a major life or traumatic event.1-3Items are rated with reference to the past 7 days on a 5-point scale, ranging from 0 to 4. Three subscale scores are calculated by taking the mean of the item responses: Intrustion (8 items), Avoidance (8 items), and Hyperarousal (6 items). The total score is similarly computed by taking the mean of all 22 items. All scores range from 0 to 4, with higher scores indicating higher event-related distress. Internal consistency estimates(Cronbach's alpha) for all scores range between 0.79 to 0.92.
15785393|NCT04569773|Behavioral|Reproductive Concerns Scale|The RCS is a 14-item, 5-point Likert-type self-report measure that assesses concern among cancer survivors whose reproductive ability may have been impaired or lost due to disease and/or treatment. Answers are rated on a 5-point scale (0 to 4), and a single total score is produced by summing responses to all 14 items (range, 0-56 points). A higher score represents more reproductive concerns, and a lower score represents fewer reproductive concerns. In the RCS validation study, internal consistency reliability was 0.91 among long-term female cancer survivors and 0.81 among control women.
15785489|NCT04568993|Drug|Volar to the MCP-joint|Injection of methyl prednisone and lidocaine in the tendon sheet volar to the MCP-joint
15785490|NCT04568967|Diagnostic Test|Concentrated urine with Xpert Ultra|Molecular TB diagnostic test on urine
15785491|NCT04568967|Diagnostic Test|urine with Fujifilm SILVAMP TB LAM test|Lateral flow TB diagnostic test on urine
15785592|NCT04568200|Drug|Carboplatin|Chemotherapy
15785593|NCT04568200|Drug|Paclitaxel|Chemotherapy
15785394|NCT04569773|Behavioral|Decision Regret Scale|"The DRS is a 5-item, 5-point Likert-type self-report measure that assesses distress or remorse after a health-care decision.5 Items are rated on a scale from 1 (strongly agree) to 5 (strongly disagree). Two of the statements (items 2 and 4) are phrased in the negative direction.
~A single, total score is produced by first reversing the scores of the 2 negatively phrased items, then taking the mean of the 5 items. This mean is then rescaled to range from 0 to 100 by subtracting 1, then multiplying by 25. A score of 0 indicates no regret, whereas a score of 100 indicates high regret. Internal consistency reliability coefficients for the DRS range from 0.81 to 0.92."
15785395|NCT04569760|Drug|50:2 mg(CBD:THC)/ml - Cannabinoid Oil Oral Preparation- titrated as tolerated up to a maximum 8mls twice daily (200 mg- 800 mg total dose)|Oral cannabinoid oil preparation dosed in 1ml increments
15785396|NCT04569760|Drug|Placebo Oil|Oral MCT Oil Preparation - No cannabinoids- titrated as tolerated up to a maximum of 8mls twice daily (equivalent to 200 mg- 800 mg total dose of the active product)
15785397|NCT04569747|Combination Product|Pertuzumab+TRASTUZUMAB|Trastuzumab + pertuzumab SC FDC (PHESGO) will be administered on Day 1 of each 21-day cycle , subcutaneous, fixed dose
15785398|NCT04569747|Drug|ADJUVANT ENDOCRINE THERAPY|Oral, daily per cycle
15785399|NCT04569734|Procedure|WATCHMAN device implant procedure utilizing ICE probe|The study will be a prospective, non-randomized multicenter registry of 100 patients undergoing LAA closure with the WATCHMAN device (possibly with WATCHMAN FLX when approved) utilizing an intra-procedural ICE probe under moderate sedation.
15785400|NCT04569721|Device|CT Guided Splanchnic Cryoablation|The patient will be sedated and continuously monitored by the anesthesia team, who will be present for the entire procedure. The puncture site will be anesthetized with 1% Lidocaine infiltration. Following tract anesthesia, and utilizing fluoroscopic CT guidance, four cryoablation probes (Ice Rods®) will be advanced, 2 on each side. In addition, a temperature monitoring probe (Boston Scientific, Multipoint 1.5 Thermal Sensor®) will be advanced on each side. The cryoablation process will include a 10-minute freeze, followed by a 3-minute passive thaw, and a brief active thaw to facilitate probe removal. A final scan will be obtained following removal of the probes. After the procedure, a sterile dressing will be applied, and subjects will be monitored for at least 12 hours in an observation bed in the hospital post-procedure.
15785401|NCT04569708|Other|Auditory stimulation|Quiet auditory stimulation timed with sleep physiology
15785403|NCT04569682|Device|LifePort transrenal artery perfusion|transrenal artery perfusion group
15785404|NCT04569682|Device|LifePort transrenal vein perfusion|transrenal vein perfusion group
15785405|NCT04569669|Diagnostic Test|FFR and FFRCT|All the patients will undergo computed coronary tomography angiography to analysis FFRCT . Then FFR will be measured during invasive cardiac catheterization.
15785406|NCT04569656|Drug|hydrolyzed guar gum|treatment with Stick pack 30 ml containing PHGG 5 gr e Hyaluronic Acid 200 mg for 6 weeks
15785407|NCT04569643|Diagnostic Test|Actigraphy|Participants will undergo overnight leg actigraphy at baseline. Leg movements will be recorded bilaterally by actigraphic method with two ankle-worn recorders.
15785408|NCT04569643|Diagnostic Test|Cardiorespiratory monitoring|All participants will be scanned for presence of sleep-related breathing disorders with a portable monitoring device at baseline. The compact screening device will be attached to the patient's wrist during the night sleep.
15785409|NCT04569643|Diagnostic Test|Neuroimaging|All subjects will undergo brain MRI scanning at baseline and in 1-year follow-up. The imaging protocol will include axial T1, T2, T2*, FLAIR and diffusion-weighted imaging scans that will be made on a 3-Tesla scanner.
15785410|NCT04569643|Other|Assessment of cognitive function|Assessment will take place at weeks 0 (baseline) and 52 (1 year follow-up). The neuropsychological protocol will be consist of Montreal Cognitive Assessment (MoCA), 12-word Verbal Memory Test, Benton Visual Retention Test, Frontal Assessment Battery, Trail Making Test (parts A and B), phonetic (as a part of the MoCA) and semantic verbal fluency assessment, Symbol Digit Modalities Test.
15785411|NCT04569643|Other|Sleep quality and mood questionnaires|Self-reporting scales and questionnaires will be used at baseline to assess sleep quality, daytime functioning and mood. The protocol includes the Pittsburgh Sleep Quality Index, the Epworth Sleepiness Scale, the Geriatric Depression Scale.
15785412|NCT04569630|Other|Controlled hypoglycaemic state while driving|Participants will drive on a designated circuit with a real car on a test track accompanied by a driving instructor. Driving data will be recorded in 4 subsequent glycemic states using an adapted hypoglycemic clamp protocol: euglycemia (d1, 5-8 mmol/l), progressive hypoglycaemia (d2, declining from 4.5 to 2.5 mmol/l), stable hypoglycemia (d3, 2.0-2.5 mmol/l), and again in euglycaemia (d4, 5-8 mmol/l). Patients will be blinded to their glucose levels.
15785413|NCT04569617|Other|Resistance Training - UL endurance protocol|UL endurance protocol - 2 series of 20 repetitions, elbow flexion at 40% of the maximum test force of 1 maximum repetition, (recovery 1 minutes between sets).
15785414|NCT04569617|Other|Resistance Training - UL strength protocol|UL strength protocol - 2 series of 8 repetitions, elbow flexion at 80% of the maximum test force of 1 maximum repetition, (recovery 1 minutes between sets).
15785415|NCT04569617|Other|Resistance Training - LL endurance protocol|LL endurance protocol - 2 series of 20 repetitions, elbow flexion at 40% of the maximum test strength of 1 maximum repetition, (recovery 1 minutes between sets).
15785416|NCT04569617|Other|Resistance Training - LL strength protocol|LL strength protocol - 2 series of 8 repetitions, knee extension at 80% of the maximum test force of 1 maximum repetition, (recovery 1 minutes between sets).
15785417|NCT04569604|Diagnostic Test|MRI scans|Contrast-enhanced, magnetic resonance imaging (MRI) based method to detect disturbances in microvascular flow patterns in the human brain
15785418|NCT04569604|Diagnostic Test|Neuro cognitive tests|Standard neuropsychological test battery consists of validated tests to assess cognitive domains including verbal and visual memory, attention, language, visuospatial and executive functioning.
15785419|NCT04569604|Diagnostic Test|Questionnaires on Quality of Life|SF36v2, WHO-5 well-being index, HPQ28, Symptom questionnaire, and a general questionnaire on background information, medication and diet.
15785420|NCT04569604|Diagnostic Test|Blood samples|Markers of calcium homeostasis, inflammatory markers and hematology.
15785421|NCT04569604|Diagnostic Test|24 hr urine samples|24 hr urine content of calcium, phosphate, magnesium, and creatinine.
15785423|NCT04569578|Other|Policy|"The intervention will include:
~i. Formalized physical activity policies implemented in preschools including the following:
~A minimum of 3 hours of total daily outdoor time scheduled both in the morning and in the afternoon
~At least 10 minutes teacher-led active play per day
~A minimum of 1 weekly outdoor excursion
~Meet the children outdoors when they arrive at preschool and/or picked up by their parents
~Only use screen tablets and computers for educational teaching purposes
~Communicating to, and encouraging, the parents to actively transport their children to and from preschools
~ii. A study website with an activity bank also serving as a platform for inter-professional education that preschool teachers can share and communicate about engaging activities and experience
~iii. Weekly follow-up and feedback by web-based questionnaires"
15785424|NCT04569565|Device|PleurX catheter|Placement of PleurX catheter for refractory cirrhotic ascites, with follow up monitoring
15785425|NCT04569539|Device|Ultrasound|Ultrasound scan of the cricothyroid membrane
15785426|NCT04569526|Device|use of intraoperative ultrasound|Ultrasonography guided brain lesions resection intra operatively for good localization
15785427|NCT04569513|Biological|Thyroid and parathyroid disease|To analyze surgery or not, different surgical methods, timing of surgery, and alternative managements for patients of thyroid or parathyroid disease.
15785428|NCT04569500|Other|PETAL program|patients and their close relations will benefit from the therapeutic education program PETAL in order to accompany them throughout their experience of laryngectomy and to reduce its impact on social and professional aspects of life.
15785429|NCT04569487|Procedure|Biopsy|Muscle biopsy from vastus lateralis (100-200 mg from non-dominant leg)
15785430|NCT04569474|Device|Transparent dressing|Use of sterile transparente dressing
15785435|NCT04569448|Drug|Brexpiprazole|Adjunctive variable dose (1-3 mg/day) Brexpiprazole
15785436|NCT04569435|Drug|ANX005|Intravenous Infusion
15785437|NCT04569422|Drug|Benoxyl|reduce pain
15785438|NCT04569409|Biological|ALLO-ASC-DFU|Application of ALLO-ASC-DFU sheet to Diabetic Wagner grade 2 Foot Ulcer
15785439|NCT04569409|Procedure|Vehicle Sheet|Application of Vehicle sheet to Diabetic Wagner grade 2 Foot Ulcer
15785440|NCT04569396|Diagnostic Test|Biochemistry analysis|Biochemistry analysis of liver parameters were analyzed among the study subjects before and after the surgery.
15785441|NCT04569396|Diagnostic Test|NAFLD fibrosis score|NAFLD fibrosis score was determined among the study subjects before and after the surgery.
15785442|NCT04569396|Other|BMI measurement|BMI was measured among the study subjects before and after the surgery.
15785443|NCT04569396|Diagnostic Test|Fibrosis 4 Index|Fibrosis 4 Index was determined among the study subjects before and after the surgery.
15785444|NCT04569396|Diagnostic Test|Fatty Liver Index|Fatty Liver Index was determined among the study subjects before and after the surgery.
15785445|NCT04569383|Biological|MVA-SARS-2-S vaccinations (days 0 & 28)|Vaccination with MVA-SARS-2-S in two escalating dose regimens
15785446|NCT04569383|Biological|Comirnaty|Vaccination with Comirnaty (21 day interval)
15785447|NCT04569370|Procedure|Laparoscopic Cholecystectomy|Surgical removal of Gall bladder using laparoscopy
15785448|NCT04569357|Drug|Prospecta|Oral administration.
15785449|NCT04569357|Drug|Placebo|Oral administration.
15785450|NCT04569344|Other|Laboratory test positive for SARS-CoV-2 virus|Exposure/intervention: diagnosis of Covid-19, defined as positive laboratory test for SARS-CoV-2
15785451|NCT04569331|Procedure|Stimulation of efferent loop|"Stimulation of efferent loop: 3 weeks before the ileostomy closure surgery, efferent loop will be stimulated with 250 ml of water and thickened.
~This procedure consists of introducing through the light efferent loop ileostomy 250 ml of water with thickener every 48-hours during the first two weeks and once daily the thrid week with a Foley catheter. Patient will be provided with all the material and the procedure sheet for all the stimulation of the efferent loop sessions. This technique will be performed at patient's home until the day before the ostomy patient closure surgery."
15785452|NCT04569331|Procedure|Rehabilitation pelvic floor|3 months after the closure of the ileostomy, you will be referred to the pelvic floor rehabilitation unit,where will start 15 individual sessions, 2 days a week (8 weeks of sessions), with reeducation of defecatory habits and hygienic-dietary measures, defecation record where assess stool consistency using the Bristol Scale and number of bowel movements that take place in 24 hours, muscle toning exercises (Exercises Kegel), Biofeedback (BF), rectal balloon work to improve sensitivity and accommodation, reeducation of the expulsive maneuver, and perineal block in situations hyperpressive.
15785453|NCT04569318|Device|Treatment Beam|One of the subject's eyes will be treated with the 415 nm treatment beam (20mW) up to 8 times for 15 minutes.
15785454|NCT04569305|Procedure|Negative Pressure Wound Therapy|NPWT technique was applied to injured area of the foot and ankle after debridement and cleaning of the necrosed tissue and using Vacuum Assisted Closure (VAC) consisting of evacuation tube, vacuum pump, collecting canister and a multiporous polyurethane sponge. VAC dressings were changed every 72 hours.
15785455|NCT04569305|Procedure|Conventional treatment|In conventional treatment moist gauze dressings were applied and change of dressings were done daily.
15785456|NCT04569292|Other|No intervention on patients|No intervention on patients
15785535|NCT04568694|Procedure|Delayed Lung Transplantation|Transplants with a planned recipient anesthesia start time between 10:00 pm and 6:00 am will be allowed to move to a start time between 6:00 am and 8:00 am at the earliest. Donor lung(s) cross clamp time must occur between 5:00 pm and 4:00 am. Lungs that meet criteria will be transported in the usual fashion in a cooler of ice at 4oC. Upon arrival to NYULH, the lungs will be transferred to cold static preservation at 10oC within a specific incubator located in a NYULH OR (MYTEMP™65HC, Benchmark Scientific).
15785457|NCT04569279|Drug|Rivaroxaban|Rivaroxaban (Rovaltro®) is a novel oral anticoagulant that acts selectively, reversibly, and potently on activated Factor X (Factor Xa) inhibiting a critical point on the coagulation cascade. Rivaroxaban has excellent bioavailability, rapid onset of peak anticoagulation effect, and predictable pharmacokinetic and pharmacodynamic properties making routine laboratory monitoring and dose adjustments almost unnecessary (11). Rivaroxaban is an extensively studied drug and has received approvals for anticoagulation in several preventive and therapeutic indications (11). Now medical literature has some solid evidence that Rivaroxaban is comparable with other anticoagulants in terms of efficacy. Several studies imply that Rivaroxaban may have a lower risk of major bleeding (11). Several reports and small case-series (12,13) suggest that rivaroxaban may be beneficial as Warfarin in the treatment of cerebral venous thrombosis (CVT) with less or no major complications.
15785458|NCT04569279|Drug|Warfarin|Warfarin (Orfarin®) is the most popular vitamin K antagonist and is considered the standard of care in many venous and arterial anticoagulation indications with extensive clinical experience regarding its use. This inexpensive and effective drug has a narrow therapeutic window that is affected by diet changing and many drug interactions, making frequent monitoring with prothrombin time (PT)/international normalized ratio (INR) highly important.(14)
15785459|NCT04569266|Other|specific exercise rehabilitation treatment|"Patients meeting the eligibility criteria will be selected consecutively. They will be contacted by telephone after at least 3 months post-resuscitation. The mMRC score is then evaluated. In case of mMRC>1, the study will then be proposed by the physiotherapist or the referring investigating physician of each participating center during this call. The patient is then offered an appointment on the reference rehabilitation platform of each center. The CDM measurement as well as the quality of life by the SF-12 scale are also carried out. Patients are then randomized in one of the two groups (control or treatment)."
15785460|NCT04569240|Device|Dexcom G6 continuous glucose monitor|Dexcom G6 continuous glucose monitor will be applied to the upper outer arm before cardiovascular surgery. Data will be collected for 10 days or upon discharge from the ICU.
15785461|NCT04569227|Drug|EC-18|2000 mg PO daily
15785462|NCT04569227|Drug|Placebo|PO daily
15785463|NCT04569214|Drug|PAZ320|Treatment arm B - 2 tablets of PAZ320 and 2 tablets of placebo, total of 4 tablets Treatment arm C - 4 tablets of PAZ320
15785464|NCT04569214|Other|Placebo|Treatment arm A - 4 tablets of placebo Treatment arm B - 2 tablets of PAZ320 and 2 tablets of placebo, total of 4 tablets
15785465|NCT04569201|Procedure|Endoscope|The use of the neuro endoscope in excision of intraventricular lesions either alone or in assistance of the surgical microscope
15785466|NCT04569188|Biological|Convalescent plasma|COVID-19 elderly patients treated with convalescent plasma
15785467|NCT04569175|Other|3D Flair sequence|Optimized 3D FLAIR sequence before and 4 hours after the usual care MRI (with contrast product). All patients will have the same intervention as each patient is its own control
15785468|NCT04569136|Other|Education|The education session including education about mastitis, feeding techniques, lifestyle changes, thermal/cryo therapy and demonstration of breast self-massage will take approximately 20 minutes.
15785469|NCT04569136|Other|Therapeutic ultrasound|Participants will be treated with 5 minutes of therapeutic ultrasound (pulsed mode) at a frequency of 1 Mega Hertz, a duty cycle of 20%, a pulse intensity of 1.8 Watt/centimetre squared. The ultrasound probe will be moved at a speed of about 4 centimetre/second. The intensity and duration will be adjusted if the patient complains of discomfort. The ultrasound transducer head will massage over the tender point on the breast.
15785470|NCT04569136|Other|Sham ultrasound|Participants will receive 5 minutes of 'sham' ultrasound at 0 Watt/centimetre squared intensity from a physical therapist.
15785471|NCT04569136|Other|Breast massage|Breast massage includes general and focused massage. Participants will lie in supine position. The breast massage will be applied according to the Vodder method to the affected breast.
15785472|NCT04569136|Other|Usual obstetric care|Usual obstetric care may include verbal advice/printed patient information regarding mastitis and breastfeeding from the medical or nursing staff.
15785473|NCT04569123|Device|real stimulation|Participants will undergo standardized hand task practice therapy (3 sessions/week for 6 weeks) with the watch worn on the paretic wrist. Participants will be randomized into two groups: The device will deliver vibration for the treatment group.
15785474|NCT04569123|Device|No stimulation|Participants will undergo standardized hand task practice therapy (3 sessions/week for 6 weeks) with the watch worn on the paretic wrist. Participants will be randomized into two groups: The device will deliver no vibration for the control group during therapy.
15785475|NCT04569110|Other|Not applicable. Observational study. Retrospective analysis of samples.|Not applicable. Observational study. Retrospective analysis of samples.
15785476|NCT04569097|Other|standard of care lingual strengthening|standard or care lingual strengthening approaches with outcome measured with novel pressure metrics
15785479|NCT04569071|Device|Sinovation Laser Ablation System|In the present single arm study. All eligible subjects will undergo MgLiTT with the Sinovation Laser Ablation System.
15785480|NCT04569058|Device|Transcranial Photobiomodulation|Transcranial Photobiomodulation--a noninvasive intervention in which near-infrared light (850 nanometer) is applied to forebrain.
15785481|NCT04569045|Device|HA+Lidocaine|20 mg
15785482|NCT04569045|Device|HA|20 mg
15785487|NCT04569019|Other|Vacciantion status in health care workers|Education among HCW about benefits of influenza vaccination. Using posters, email, conversations, informations about vaccination used during vaccination Vaccinating during working hours Vaccinating for free Vaccinating inside departments ( not in special clinic)
15785488|NCT04568993|Procedure|Proximal phalangeal level|Injection of methyl prednisone and lidocaine in the tendon sheet at the level of the proximal phalanx
15785536|NCT04568694|Procedure|Conventional Lung Transplantation|Reference Therapy
15785492|NCT04568954|Diagnostic Test|Xpert MTB/RIF Ultra using GeneXpert Omni|Xpert MTB/RIF Ultra, a molecular diagnostic test developed by Cepheid, detects TB more accurately than microscopy and provides a result within 90 min. The diagnostic test is run on the GeneXpert platform. The GeneXpert® Omni is able to perform the same TB diagnostic test as the conventional GeneXpert but has been designed specifically to be located at primary health care facilities. It is smaller and easier to operate with an internal battery. There is no need for a computer or laptop, as it is operated by a mobile phone.
15785493|NCT04568941|Behavioral|Vacuum-Assisted Biopsy|Vacuum-Assisted Biopsy
15785494|NCT04568941|Behavioral|Core Needle Biopsy|Core Needle Biopsy
15785495|NCT04568941|Behavioral|Intraoperative Excisional Biopsy|Intraoperative Excisional Biopsy
15785496|NCT04568928|Device|OLTP/PE + FES|12 sessions OLTP/PE + FES
15785497|NCT04568928|Device|OLTP/PE +shamFES|12 sessions OLTP/PE +sham FES
15785498|NCT04568928|Device|OLTP/PE no FES|24 sessions OLTP/PE no FES
15785499|NCT04568915|Other|Dry Needling|TENS 10 minutes, Stretching, Strengthening(girdle),Neck Isometrics, DN
15785500|NCT04568915|Other|Maitland Mobilization|TENS 10 minutes, Stretching, Strengthening(girdle),Neck Isometrics, Maitland joint mobilization
15785503|NCT04568889|Behavioral|A $10 Survey Incentive|Individuals see a 10 dollar incentive on the flyers advertising the baseline survey.
15785504|NCT04568889|Behavioral|A $20 Survey Incentive|Individuals see a 10 dollar incentive on the flyers advertising the baseline survey.
15785505|NCT04568889|Behavioral|Emphasis of Government Involvement|Individuals see a message emphasizing the involvement of the government in the study,
15785506|NCT04568889|Behavioral|Emphasis of Academic Researchers Involvement|Individuals see a message emphasizing the involvement of academic researchers in the study,
15785507|NCT04568889|Behavioral|Cost-Benefit Frame|Individuals will see messaging that emphasizes the public health benefits of answering the survey questions in the baseline survey (cost-benefit frame).
15785508|NCT04568889|Behavioral|Duty Frame|Individuals will see messaging that emphasizes an individual's responsibility to their community in the baseline survey (duty frame),
15785509|NCT04568889|Behavioral|Racial/Ethnic Frame|Individuals will see messaging that emphasizes the disproportionate impact of COVID-19 on certain ethnic and racial groups in the baseline survey.
15785510|NCT04568889|Behavioral|No Messaging|Individuals will see no messaging in the baseline survey.
15785511|NCT04568876|Dietary Supplement|Micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) oral suspension|Micronized and ultra-micronized Palmitoylethanolamide is on the market in Italy as a Food for Special Medical Purposes
15785512|NCT04568876|Combination Product|Standard Therapy|Standard therapy established for individual patients
15785513|NCT04568863|Drug|Melatonin intravenous|7 days of 5 mg per Kg of actual body weight per day of intravenous melatonin every 6 hours. Maximum daily dose 500 mg per day.
15785514|NCT04568863|Drug|Placebo intravenous|7 days of 5 mg per Kg of actual body weight per day of intravenous identically-looking placebo every 6 hours.
15785515|NCT04568850|Diagnostic Test|Plasma IgG levels|Plasma IgG levels of subjects who tested reactive for IgG SARS CoV-2 antibodies will be monitored every month for 4 months for IgG levels
15785516|NCT04568837|Drug|Prednisone 20 Mg|20 mg of Prednisone or 1 mL of 4 mg/mL Dexamethasone Sodium Phosphate will be administered each day for participants in the intervention group
15785517|NCT04568824|Other|GraphoLearn reading intervention|This is an Edtech reading intervention
15785518|NCT04568824|Other|Vektor math control intervention|This is an Edtech math/cognition intervention
15785519|NCT04568811|Biological|Adenovirus Type-5 Vectored COVID-19 Vaccine|Low dose adenovirus type-5 vectored COVID-19 vaccine (5E10 vp)
15785520|NCT04568798|Device|Sana Sham Device|Externally worn mask that physically contacts the skin of the face. The Sana Device delivers Audio Visual Stimulation (AVS) in the form of coordinated pulses of light (through closed eyelids) and sound at various frequencies.
15785521|NCT04568785|Behavioral|Brief Intervention for Influenza vaccine|Previous to the intervention, patients were asked about the reasons to reject the influenza vaccine. Brief Intervention was performed by the healthcare professional during the consultation. It was given verbally, with written support.
15785522|NCT04568785|Behavioral|Normal advice|In the CG the influenza vaccine advice was the normal advice that professionals used to give their patients and was not asked for the reasons for the rejection of the vaccine to prevent them from influencing the advice.
15785523|NCT04568772|Drug|Atovaquone / Proguanil 250/100 mg|Atovaquone / Proguanil 250/100 mg tablet
15785524|NCT04568772|Drug|Tegoprazan 50 mg|Tegoprazan 50 mg tablet
15785525|NCT04568772|Drug|Esomeprazole 40 mg|Esomeprazole 40 mg tablet
15785526|NCT04568772|Drug|Vonoprazan 20 mg|Vonoprazan 20 mg tablet
15785527|NCT04568759|Other|Global postural re-education|GPR consists of active treatment posture and sensorimotor control exercises to regain back muscle symmetry and correct posture in daily activities
15785528|NCT04568746|Procedure|emergency vital room|At the arrival of the patient, the qSOFA will be carried out to guide the orientation. Patient with score ≥ 2 will be supported in emergency vital room
15785529|NCT04568746|Procedure|box|patient with score < 2 will be supported in box
15785530|NCT04568733|Behavioral|Pilates exercise session|The Pilates session will consist of warm-up exercises (e.g. breathing, arm circle, cat and camel spinal rotation etc.) and basic mat exercises (e.g. one leg stretching, double leg stretching, the hundred, saw, rolling like a ball, swimming, pelvic curl etc.). The Pilates session will be presented to the participants via pre-recorded video.
15785531|NCT04568733|Behavioral|Treadmill walking at 3.2 kph|Participants will walk on a treadmill at 3.2 kph (2 mph) speed for 10 minutes.
15785532|NCT04568733|Behavioral|Treadmill walking at 4.8 kph|Participants will walk on a treadmill at 4.8 kph (2 mph) speed for 10 minutes.
15785533|NCT04568720|Diagnostic Test|blood sample|Isolated the blood sample and detected the CTC
15785534|NCT04568707|Other|blood sample|blood sample for serum (serology, biomarkers) and DNA
15785537|NCT04568681|Device|Deep brain stimulation (DBS)|Deep brain stimulation is an FDA approved therapy that involves surgical implantation of electrodes in deep brain targets and an implantable pulse generator delivers electrical pulses.
15785538|NCT04568668|Device|ActionADE|"ActionADE is a software application that allows healthcare providers to document standardized adverse drug event information in a user-friendly and standardized manner. We integrated ActionADE uni-directionally with PharmaNet, a secure province-wide network that links all pharmacies in British Columbia to a central data system. This allows care providers to pull in demographic information and visualize their patient's medication dispensing history.
~In 2020, we enabled bi-directional integration with PharmaNet allowing clinicians to transmit standardized adverse drug event information back to the PharmaNet database. The three dominant community pharmacy systems in the geographic area of the trial will display the adverse drug event information in their systems, and generate patient-specific medication-level alerts when pharmacists attempt to re-dispense a culprit medication."
15785539|NCT04568655|Device|noninvasive ventilation|noninvasive ventilation to support the COVID-19 patients with respiratory failure
15785540|NCT04568642|Device|Activate FiO2 controller|Closed-loop FiO2 controller will be activated in the experimental arm
15785541|NCT04568642|Device|Deactivate FiO2 controller|Closed-loop FiO2 controller will be deactivated in the experimental arm
15785542|NCT04568629|Other|Online study|Five patient summaries
15785543|NCT04568616|Drug|Letrozole 2.5mg|Aromatase Inhibitor
15785544|NCT04568603|Drug|Islatravir|ISL 30 mg x 2 (60 mg total) capsules taken by mouth.
15785545|NCT04568603|Drug|Methadone|Methadone 20 to 200 mg QD taken by mouth.
15785546|NCT04568590|Behavioral|educational intervention|If the guardian screens positive for vaccine hesitancy (i.e., vaccine hesitancy score average > 3), they will be given the informational handout along with a brief script.
15785547|NCT04568577|Other|Tape with tension|The elastic bandage will be applied with a voltage increase controlled weekly, for five weeks. Each week, 5% of tension will be added to the application. In the first week the application will be tension-free.
15785548|NCT04568577|Other|Tape without tension|Bandaging applications will be weekly, for five weeks, without tensioning the tape.
15785551|NCT04568538|Other|Training program|"A training program and booklet content for the education to be given to mothers includes the following topics.
~What is shaken baby syndrome and what is its cause?
~What are the harms caused by shaken baby syndrome?
~How is shaken baby syndrome understood?
~What problems can shaken baby syndrome cause?
~What are the measures to be taken? For the training and the content of the booklet, expert opinion was obtained from 10 academic members who are experts in the field of Child Health. An evaluation form was created for pre-test and post-test measurements. Expert opinions were also received for these forms.
~Mothers of 2-4 months old babies who applied to Akdeniz University Hospital Pediatric Outpatient Clinic for check-up were randomized with a sealed envelope and accepted the study. In this way, intervention and control groups can be determined. After the pre-test is done in the intervention group, 2-month training, booklet and tele-consultancy services will be provided."
15785552|NCT04568525|Diagnostic Test|Passive Microwave Radiometry|The MWR2020 (ormer RTM-01-RES) device is a unique commercially available CE marked device. It is registered in UK MHRA MDN 40802 as Microwave thermography system for clinical studies. The device is already registered in Kyrgyzstan for breast cancer diagnostics. During the 1980-90s there were several works on identification of excess of microwave emission due to fluid in lungs (on phantoms) which could be indication of inflammatory, process, cancer and other lung disorders.Later results were confirmed by clinical studies for lung cancer
15785553|NCT04568512|Diagnostic Test|Control|Brushed biliary samples from a known case of benign biliary stricture were sent for DNA Methylation Biomarker test and cell cytology
15785554|NCT04568512|Diagnostic Test|Cholangiocarcinoma|Brushed biliary samples from a known case of cholangiocarcinoma were sent for DNA Methylation Biomarker test and cell cytology
15785555|NCT04568486|Other|Diabetes Empowerment Education Program|The Diabetes Empowerment Education Program (DEEP) is an education curriculum designed to help people with pre-diabetes, diabetes, relatives and caregivers gain a better understanding of diabetes self-care. Classes last a total of six weeks, providing participants with eight unique learning modules. Health literacy will be assessed before and after participating in DEEP.
15785556|NCT04568473|Other|PRG Barrier Coat (By SHOFU Inc., Japan)|PRG Barrier Coat (By SHOFU Inc., Japan) is a bioactive, resin-based varnish based on the proprietary Giomer concept which incorporates the patented bioactive S-PRG (Surface Pre-Reacted Glass ionomer) filler technology, where a unique combination of six beneficial ions are actively gradually released to provide a smart solution to revolutionize dentin hypersensitivity protocol
15785557|NCT04568473|Other|EMBRACE™ Varnish by (Pulpdent Corporation, USA)|5% sodium fluoride with CXP™ (Xylitol-coated Calcium and Phosphate) technology for unsurpassed fluoride release and it is considered as a novel method of delivering remineralizing ions (Calcium and Phosphate) in combination with xylitol. The incorporation of CXP™ in a permeable resin matrix that does not separate, purportedly drives the sustained, time-released properties of this varnish.it has ten times more fluoride release over a 4-hour period than the leading varnish brand, in addition, it also releases bioavailable calcium and phosphate ions which are nano-coated with xylitol.
15785558|NCT04568460|Other|Intervention Group Sessions|Participants will undergo a multi-session group intervention over the course of six months.
15785559|NCT04568447|Device|IMOOVE|Imoove® is a device dedicated to rehabilitation and fitness and has the capacity to increase muscle tenfold.
15785562|NCT04568421|Drug|Immunosuppressive Agents|Immunomodulatory and/or immunosuppressive drugs according to the indication of the treating physician
15785564|NCT04568395|Other|TCIG|Use a TCIG
15785569|NCT04568369|Device|rTMS|See treatment arm description.
15785570|NCT04568356|Diagnostic Test|Direct Antigen Tests for COVID-19|Rapid Antigen diagnostic device performance comparative to RT-PCR
15785571|NCT04568343|Device|Capsule endoscopy|We use two capsule endoscopy for evaluation their diagnostic yield. Patient will recieve different capsule endoscopy:The Endocapsule (EC-10) and CapsoCam Plus (Capsovision) capsule
15785572|NCT04568330|Other|best support care|Best support care
15785573|NCT04568330|Other|moisture cream|BSC plus moisture cream
15785574|NCT04568330|Other|10% urea-based cream|BSC plus 10% urea-based cream.
15785575|NCT04568317|Behavioral|Space from Depression|This is a 7-module internet-based CBT program. The structure and content of the modules follow evidence-based CBT principles; they are structured to incorporate quizzes, videos, psychoeducational content and interactive tools, personalised homework suggestions and summaries. One of the interactive tools is the mood monitor, where users are encouraged to monitor their mood and reflect on several factors that might had influenced it. Clients are allocated to a psychological wellbeing practitioner (PWP). The PWP is responsible for monitoring and guiding the client's progress throughout the intervention. Over the course of the 8 week supported intervention period, on 6 separate occasions the PWP will review participants progress, leaving feedback for them and responding to the work they have completed. The basic share level allows PWP is to view users' goals for the week, key messages and progress points. Each PWP will provide post-session feedback of between 10 and 15 minutes per session.
15785576|NCT04568317|Device|Mood Monitor watch app|"The Mood Monitor watch app will allow in-the-moment self-report of patients' mood and automated monitoring of their sleep and activity level. This data will be integrated into the existing Mood Monitor tool within the participant's Space from Depression program. During the intervention, prompts to record mood data will appear on the watch app; participants will be encourage to choose the frequency and time ranges to receive prompts. The watch app main screen will provide a daily and weekly visualisation of participant's mood, bedtime, hours slept and steps count, and visual cues on their progress. Participants will receive encouragement prompts to reward frequent and consistent self-report of mood over time and a good sleep hygiene. Finally, the app Tips to Stay Well feature will allow participants to go through a list of lifestyle-related tips extracted from the Space from Depression program."
15785577|NCT04568304|Biological|Toripalimab Injection|Toripalimab Injection 240 mg iv infusion on Day 1 of each 3-week cycle. The cumulative duration of Toripalimab Injection is up to 2 years.
15785578|NCT04568304|Drug|Gemcitabine Hydrochloride for Injection|"Gemcitabine 1000mg/㎡ iv infusion, on Day 1 and Day 8 of each cycle, each treatment cycle is 3 weeks.
~The chemotherapy regimen will be administered for 6 cycles."
15785579|NCT04568304|Drug|Cisplatin for Injection / Carboplatin Injection|"Cisplatin 70mg/㎡ iv infusion, on Day 1 or Day 2 of each cycle, each treatment cycle is 3 weeks.
~Carboplatin AUC 4.5 iv infusion, on Day 1 or Day 2 of each cycle, each treatment cycle is 3 weeks.
~The chemotherapy regimen will be administered for 6 cycles."
15785580|NCT04568304|Drug|Placebo|Placebo iv infusion on Day 1 of each 3-week cycle. The cumulative duration of placebo is up to 2 years.
15785581|NCT04568291|Other|model treatment|the treatment decisions were decided by Machine Learning （ML） model in model treatment group
15785582|NCT04568291|Other|routine treatment|the treatment decisions were decided by multi-disciplinary team （MDT）
15785583|NCT04568278|Other|ePRO-CTCAE application|The intervention will be the use of a mobile application for recording symptoms during cancer treatments. Patients in the intervention group will have the mobile application (e-PRO) installed on their smart phones on the first day of cancer treatment (chemotherapy or radiation therapy) and patients will be asked to use the application for 8 weeks. Every week, the application will ask patients to report symptoms they experienced during past 7 days using the pre-specified PRO-CTCAE questions for different types of cancer. Patients also can memo and save photos related symptoms using the application and patients can monitor the progression of the symptoms over time.
15785584|NCT04568265|Drug|APG-1387|Weekly intravenous infusion for 30 minutes
15785585|NCT04568265|Drug|Entecavir 0.5 mg|Taken daily by mouth
15785586|NCT04568252|Device|Wristband with millimeter wave emission.|Wristband treatment with millimeter wave emission twice a day for 3 months.
15785587|NCT04568252|Device|Placebo of wristband with millimeter wave emission.|Treatment with a millimeter wave emission wristband placebo twice a day for 3 months.
15785588|NCT04568226|Other|ConquerFear Intervention|ConquerFear is a manualized intervention, consists of six individual sessions over 10 weeks. The key goals of this intervention are the following: (1) teach strategies for controlling worry and excessive threat monitoring, (2) modify underlying unhelpful beliefs about worry, (3) develop appropriate monitoring and screening behaviours, (4) encourage acceptance of the uncertainty brought about by a cancer diagnosis, and (5) clarify values and encourage engagement in values-based goal setting (19). Each session will last 60-90 minutes and be delivered by a trained therapist. After each session, participants will be given home-based exercises to practice the skills learned in the sessions. With the uncertainty surrounding the COVID-19 pandemic, instead of face-to-face sessions only, a hybrid mode of intervention delivery will be used by offering participants the choice of face-to-face or online sessions.
15785589|NCT04568226|Other|Active control: Basic Cancer Care|Basic Cancer Care intervention for the control arm was developed to help cancer survivors with health maintenance in long-term through providing comprehensive lifestyle guidance. The intervention incorporates relaxation training, dietary and physical fitness consultations with the key goals to (1) teach relaxation techniques, (2) offer personalized diet and physical activity advice, and (3) enhance survivors' perceived control over illness, thereby leading to better adjustment to cancer. Similar to the ConquerFear intervention, Basic Cancer Care intervention consists of 6 individual sessions over 10 weeks. Each session will last 60-90 minutes and be delivered by a trained therapist, a registered dietitian, and an exercise physiologist, respectively. A hybrid mode of intervention delivery will be also used by offering participants the choice of face-to-face or online sessions.
15785590|NCT04568213|Drug|Hypochlorous Acid Gel 0.02%|0.02% Hypochlorous Acid Gel (OCusoft Hypochlor GEL) will be sprayed onto the closed eyelid of the surgical eye while covering the fellow eye with palm of the hand, left for 60 seconds, then wiped off with a clean gauze, tissue, or cotton ball.
15785591|NCT04568200|Drug|Durvalumab|Durvalumab 1500mg i.v. day 1-22-43-64
15785595|NCT04568187|Device|zeltiq|Zeltiq prototype device (Zeltiq Aesthetics, Pleasanton, CA) approved by FDA 2010
15785596|NCT04568187|Device|placebo|radiofrequency with 3000 Hz
15785597|NCT04568174|Drug|PPSGG|an antibody scavenger of pathogenic anti-MAG immunoglobulin M (IgM) autoantibodies
15785598|NCT04568174|Drug|Placebo|A standard PBS solution, pH 7.4, composed of disodium hydrogen phosphate dodecahydrate, potassium dihydrogen phosphate, sodium chloride, and water for injection
15785599|NCT04568161|Procedure|Physical Characteristics|Body weight, height and waist circumference
15785600|NCT04568161|Procedure|Muscular Sympathetic Nervous Activity|Microneurography technique.
15785601|NCT04568161|Diagnostic Test|Cardiac Function|Echocardiography.
15785602|NCT04568161|Diagnostic Test|Heart rate|Electrocardiography
15785603|NCT04568161|Diagnostic Test|Blood pressure|Non-invasive photoplethysmography.
15785604|NCT04568161|Diagnostic Test|Blood Assessments|Serum and Plasma will be extracted by centrifugation. Endothelial microparticles by flow cytometry Interleukin-6 and tumor necrosis factor α by ELISA, High-sensitive reactive serum C-reactive protein by immunoturbidimetric assay, NT- ProBNP According to Central Laboratory, Hospital das Clinicas, HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo. Endothelin-1 by immunoenzymatic method Nitric oxide by gas chemiluminescence Lipoperoxidation by fluorimetry Carbonyl by spectrophotometer, and Superoxide Dismutase (SOD) by colorimetry.
15785605|NCT04568161|Diagnostic Test|Muscle blood flow|Venous occlusion plethysmography
15785606|NCT04568161|Diagnostic Test|Endothelium-dependent vascular function|Brachial ultrasound
15785607|NCT04568161|Diagnostic Test|Vascular intima-media thickness|Carotid ultrasound
15785608|NCT04568161|Diagnostic Test|Physical Capacity|Cardiopulmonary exercise test
15785609|NCT04568161|Drug|Anthracycline & Cyclophosphamide treatment scheme|Four session of intravenous (in bolus) infusion of doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 with an interval of 21 days between sessions.
15785610|NCT04568135|Other|survey|survey
15785611|NCT04568122|Device|Saliva test kit|Kit including tube with closed reagents using loop-mediated isothermal amplification (LAMP) assay to detect SARS-CoV-2 virus.
15785612|NCT04568109|Behavioral|Cognitive-behavior therapy|The manualized protocol (Gloster et al., 2011) comprise of 12 weekly sessions of CBT focusing on therapist-guided interoceptive and in-situ exposure exercises.
15785613|NCT04568096|Combination Product|Aerosolized All-Trans Retinoic acid plus oral Tamoxifen|After randomization and standard treatment The infected patients will receive Aerosolized All-Trans Retinoic Acid in gradual in 2 divided doses increases from 0.2 mg/kg/day to 4 mg/kg/day as inhaled All-Trans Retinoic Acid therapy plus tamoxifen 20mg orally once daily. for 14 days
15785614|NCT04568096|Other|Standard treatment|Standard treatment is according to the protocol of treatment of 2019-nCoV infection
15785615|NCT04568070|Diagnostic Test|mini-BESTest (Mini-Balance Evaluation Systems Test)|Balance evaluation test that has 14 tasks leading to a total possible score of 28 points requires only 10 to 15 minutes to conduct.
15785616|NCT04568070|Diagnostic Test|Berg Balance Scale|The scale is a 14-item objective measure designed to assess static balance and fall risk in adult populations.
15785617|NCT04568070|Diagnostic Test|Timed Up and Go Test|It is a simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time that a person takes to rise from a chair, walk three meters, turn around, walk back to the chair, and sit down.
15785618|NCT04568070|Diagnostic Test|Functional Reach Test|The Functional Reach Test is a single item test developed as a quick screen for balance problems in older adults. A score of 6 or less indicates a significant increased risk for falls. A score between 6-10 inches indicates a moderate risk for falls.
15785619|NCT04568057|Device|NIR Transcranial phototherapy device|1068 nm NIR helmet
15785620|NCT04568057|Device|Placebo Transcranial Device|The placebo device looks like the active device.
15785621|NCT04568044|Procedure|Blood sample|Peripheral blood sample will be obtained.
15785622|NCT04568031|Drug|AZD1222|For subjects in part 1 will have that route of Administration as Intramuscular, 5 × 1010 vp (nominal, ± 1.5 × 1010 vp) on V2
15785623|NCT04568031|Drug|0.9% (w/v) saline|For subjects in placebo will have that route of Administration as Intramuscular 0.9% (w/v) saline on V2 and V6.
15785624|NCT04568018|Drug|Surfactant|Inhalation of surfactant emulsion at 150 mg
15785625|NCT04567992|Procedure|superficial cervical plexus block|ultrasound guided injection of local anaesthesia in the superficial cervical plexus
15785626|NCT04567966|Procedure|Split-block technique|Horizontal ridge augmentation using the split-block technique where a cortical bone plate harvested from the external oblique ridge was split in half and fixed at a distance from the atrophied ridge. Then autogenous bone chips were packed in the gap between the plate and the ridge.
15785627|NCT04567966|Procedure|Cortico-cancellous block graft|Horizontal ridge augmentation using a cortico-cancellous block harvested from the chin of the mandible.
15785628|NCT04567953|Other|Saliva collection|Use Spectrum Solutions SDNA1000 or Orasure collection kit or dry tube to collect 1-3 ml of saliva
15785629|NCT04567940|Behavioral|ENRED@TE: Behavioural multicomponent intervention|Information and awareness activities; activities for the acquisition of skills; activities that help the elderly to attend spaces for leisure, participation and maintenance and/or improvement of their personal relationships.
15785630|NCT04567927|Other|Ultrasonography|Venous compression ultrasonography using real-time B-mode and colour doppler in transverse and longitudinal views
15785631|NCT04567914|Diagnostic Test|Bilaterally abdominal muscle thickness with ultrasonography|AIS group was evaluated for localization of curvature and degree of curvature. Ultrasonographic measurements were performed of bilaterally abdominal muscle thickness in the supine and standing positions in both groups. Spirometry evaluation was performed in both groups
15785632|NCT04567901|Other|Death|Mortality group
15785633|NCT04567901|Other|Survive|Survival group
15785634|NCT04567888|Behavioral|Happify Teens|An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction.
15785635|NCT04567875|Other|No Intervention on patients|No Intervention on patients
15785636|NCT04567849|Behavioral|message|patient portal message
15785637|NCT04567849|Behavioral|provider|nudging calling the patient's provider
15785638|NCT04567849|Behavioral|tele-nurse|nudging calling the tele-nurse
15785639|NCT04567836|Other|Investigation of the prevalence of test positivity|"The study consists of an investigation by means of a prospective observational study with the aim of assess the prevalence of test positivity (swab or serological examination) ti covid-19 in relation to the duties and related occupational risk.
~It is used CLIA method test designed to recognize IgG antibodies directed against the S1 and S2 domains of the SARS-CoV-2 virus spike protein, selected for their ability to provide specificity for SARS-CoV-2 compared to other Coronaviruses ."
15785640|NCT04567823|Dietary Supplement|Smoothie with microalgae|Smoothie with microalgae I: Chlorella pyrenoidosa, Smoothie with microalgae II: Nannochloropsis salina, Smoothie without microalgae
15785641|NCT04567810|Drug|anti-SARS-CoV-2 IgY|anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.
15785642|NCT04567810|Drug|Placebo|Placebo matching anti-SARS-CoV-2 IgY preparation in liquid administered with a bottle with a dropper.
15785643|NCT04567797|Device|Laevo 2|The Laevo V2 is a wearable chest and back support exoskeleton. The Laevo transfers the from its chest pad to the thighs while bending forward. The passive exoskeleton (works with gas springs, not motors) transfers part of the load away from the back muscles, reducing the pressure on the spinal column. It provides a dampening effect on the back, reducing the risk of sudden back muscle contractions that needlessly overcompress the spine.
15785644|NCT04567797|Device|backX|"backX is a novel industrial exoskeleton that substantially augments its wearer and reduces the forces and torques on a wearer's lower back region (L5/S1 disc) by an average of 60% while the wearer is stooping, lifting objects, bending or reaching. backX augments the wearer's strength and can reduce the risk of back injuries among workers. It does not require external motors or power source. The mechanism of backX is similar to the first device Laevo 2."
15785645|NCT04567797|Device|FLx ErgoSkeleton|The FLx ErgoSkeleton is a range limiting work vest for physical work use. The FLx naturally reminds the user of the correct posture and lifting techniques while on the job site.
15785646|NCT04567797|Device|V22 ErgoSkeleton|"Similar to the FLx ErgoSkeleton, the V22 ErgoSkeleton keeps the position of the human body as to always stay within a safe body posture while lifting or moving heavy objects. The V22 ErgoSkeleton applies pressure to remind the user both during improper lifts and over rotation.
~In addition, the V22 ErgoSkeleton comes with two clutch controlled cables to assist in lifting and moving. The cables transfer part of the weight of the object being held directly to the V22 ErgoSkeleton vest, similar to other arm and shoulder support exoskeletons."
15785647|NCT04567784|Drug|Cannabidiol (CBD)|Subjects in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions
15785648|NCT04567784|Drug|Placebo|Subjects will receive a harmless, inactive solution to compare and validate the results of the other arms of the study
15785649|NCT04567771|Other|Quality-of-Life Assessment|Complete quality of life questionnaires
15785650|NCT04567771|Other|Questionnaire Administration|Complete adverse event assessments
15785651|NCT04567771|Radiation|Radiation Therapy|Undergo proton or intensity modulated radiation therapy
15785652|NCT04567758|Other|Telerehabilitation|"The home exercise program includes the following exercises:
~Lumbar region and lower extremity stretching exercises;
~Exercises to strengthen the abdominal muscles;
~Exercises to strengthen the lumbar muscles;
~Bridging, spine mobility exercise, McKenzie extension, and Williams flexion exercises
~A web-based telerehabilitation platform (Fizyoweb) will be used to deliver the exercise program. Using the Fizyoweb web application, exercises will be presented to the patients in the form of audio-video and detailed instructions with explanations. The exercise program to be given will be prescribed specifically with slight changes according to the patient's condition. The exercise protocol will be the same as in the conventional rehabilitation group. Patients will be asked to do the exercises once a day for 8 weeks and 10 repetitions each."
15785653|NCT04567758|Other|Conventional Rehabilitation|"The home exercise program, which will be given with conventional rehabilitation, will be educated to the patient in the clinic on the first day. Exercise information form including explanation and picture of the exercises will be given to the patients. The exercise program to be given will be prescribed specifically with slight changes according to the patient's condition. Patients will be asked to do the exercises once a day for 8 weeks and 10 repetitions each.
~The home exercise program includes the following exercises:
~Lumbar region and lower extremity stretching exercises;
~Exercises to strengthen the abdominal muscles;
~Exercises to strengthen the lumbar muscles;
~Bridging, spine mobility exercise, McKenzie extension, and Williams flexion exercises"
15785654|NCT04567745|Diagnostic Test|Retinal fundus photography|Fundus photographs
15785655|NCT04567732|Combination Product|injection of Filtered Autologous Adipose Tissue|Single injection of Filtered Autologous Adipose Tissue
15785656|NCT04567732|Drug|Placebo|Single injection of Placebo
15785658|NCT04567693|Other|Early spaced-out appointments|Newly-diagnosed PLWH currently attend health centers monthly for ART pick-up and quarterly for clinical visits. In the intervention arms, participants will attend health centers quarterly for ART pick-up and semi-annually for clinical visits.
15785659|NCT04567680|Behavioral|Acceptance and Commitment Therapy to Improve Social Support for Veterans with PTSD|This treatment is designed to help Veterans with PTSD increase social support in family, partner, and peer relationships by reducing experiential avoidance. ACT-SS is specifically designed to address deficits in the entire social support network for Veterans with PTSD.
15785660|NCT04567680|Behavioral|Present-Centered Therapy|"PCT is designed to provide the emotional support for individuals with PTSD that will assist with recovery. The focus of PCT is on the here and now, including current life difficulties that are directly or indirectly related to the experience of trauma. PCT aims to help the patient consider ways to react to these difficulties."
15785661|NCT04567667|Drug|[14C] BMS-986278|Specified dose on specified days
15785662|NCT04567667|Drug|Kinevac®|Specified dose on specified days
15785663|NCT04567641|Dietary Supplement|postoperative nutrition|Forty patients (50%) received enteral nutrition 6 hours after surgical procedures and 40 patients (50%) received parenteral nutrition 6 hours after surgical procedures.
15785664|NCT04567615|Biological|Nivolumab|Specified dose on specified days
15785665|NCT04567615|Biological|Relatlimab|Specified dose on specified days
15785825|NCT04566445|Drug|GT005: High Dose|The study will test two doses of GT005: Medium Dose and High Dose.
15785667|NCT04567576|Drug|Disease-modifying antirheumatic drugs (DMARDs)|"Within a non-experimental setting, the routine disease-modifying antirheumatic drugs (DMARDs) prescription will be evaluated as the exposure."
15785668|NCT04567563|Device|Remote Ischemic conditioning (RIC)|Intervention Group: Patients will self-administer RIC treatment with the LifeCuff device 3 times a week. Treatment will be delivered at the patient's home and compliance will be monitored by the LifeCuff device. Control Group: Patients undergo typical standard of care treatment. Assessment of Ulcer Closure: Ulcers will be assessed as completely closed by the Principal Investigator through clinical judgement and photographic support. Patients that completely heal their ulcer during the healing period will complete the study and no further blood or tissue measurements will be taken
15785669|NCT04567550|Biological|RGX-314 Dose 1|AAV8 vector containing a transgene for anti-VEGF fab (Dose 1)
15785670|NCT04567550|Biological|RGX-314 Dose 2|AAV8 vector containing a transgene for anti-VEGF fab (Dose 2)
15785671|NCT04567537|Device|Laser Treatment|Patients will receive three laser treatments at one-month intervals.
15785672|NCT04567524|Drug|LYN-005|LYN-005 (14 or 28 mg weekly) plus IR risperidone matched placebo.
15785673|NCT04567511|Drug|Emicizumab|bispecific monoclonal antibody binding to activated Factor IX and Factor X
15785674|NCT04567498|Other|exhaled breath sampling|The participants are requested to quietly sit and breathe to the air collecting bag until the collecting bag is full. The collecting bag is sealed and connected to the e-nose machine via a collecting hose and HEPA-filter. The data are read and stored in the e-nose machine.
15785675|NCT04567498|Other|exhaled breath sampling|The participants are requested to quietly sit and breathe to the air collecting bag until the collecting bag is full. The collecting bag is sealed and connected to the e-nose machine via a collecting hose and HEPA-filter. The data are read and stored in the e-nose machine.
15785676|NCT04567472|Behavioral|Helping Ease Anxiety and Depression following Stroke|HEADS: UP online is a group-based mindfulness course with an accompanying text-based manual. HEADS: UP comprises 9 x 2.5 hour mindfulness sessions, which incorporate a 30-minute break. A 6-hour silent retreat is offered in week 7. A follow-up session will be offered 6 - 8 weeks after the end of the course. Course materials include accessible information packs delivered weekly, electronically, and CD/audio resources to complement the sessions. The accompanying text-based manual will be delivered 'up front' (hard copy and electronic). A summary email and reminder of personal practice will be sent to participants after each session, including links to audio resources complementing class-based sessions. Signposting to other resources and media, including sites with downloadable voice files e.g. Mindfulness Scotland will be included.
15785677|NCT04567459|Dietary Supplement|Premium Amino Acids|after Chemotherapy ang surgery one pack of Premium Amino Acids in the morning and evening
15785678|NCT04567446|Other|Stool|collection at diagnosis, before initiating anticancer treatment, during treatment
15785679|NCT04567446|Other|Blood sample|40 mL collection before, 3 and 6 months of treatment cancer
15785680|NCT04567446|Other|Saliva|5 mL collection before initiation of treatment cancer
15785681|NCT04567433|Drug|Hydroxyethyl starch|Hydroxyethyl starch compared to 0.9% saline
15785682|NCT04567433|Drug|Hydrocortisone|Hydrocortisone compared to Placebo
15785683|NCT04567433|Procedure|Early Goal Directed Therapy|Early Goal Directed Therapy compared to Usual Care
15785688|NCT04567394|Behavioral|Peer Network Counseling-txt|4-week text counseling program
15785689|NCT04567381|Other|Enhanced Services|In enhanced services, the provision of services go beyond just referring a patient and leaving them to follow-through on their own accord. ES varies based on resources, model of service delivery, philosophy, and role and responsibilities of team members. Enhanced services usually includes longer-term case management which can then facilitate the connection to clinical counseling, victim assistance, familial assistance, legal assistance, emergency financial funding, transportation for subsequent appointments related to a patient's medical condition, employment assistance, and assistance in educational program enrollment.
15785690|NCT04567381|Other|Treatment as Usual|Individuals randomized to TAU will receive a list of resources which provides participants with community agency information that they can engage on their own. The list of resources will include contact information for various services such as housing, employment, mental health and legal services. Patients randomized into this condition receive little to no assistance from program staff and must navigate the vast terrain of social service providers on their own.
15785691|NCT04567368|Diagnostic Test|Xpert MTB/XDR|Cepheid Xpert MTB/XDR assay for detection of resistance to INH, FQ and SLID
15785692|NCT04567355|Behavioral|Migraine Manager|Answers provided during the online assessment will result in certain intervention recommendations. Once assessments are completed, a treatment plan will be automatically generated for patient and parent guidance.
15785693|NCT04567342|Other|1 automated message|Parents of eligible patients will receive 1 HIPAA compliant automated call or text reminder (based on preference recorded in EHR) that their child is due for a checkup and information on how to schedule an appointment.
15785694|NCT04567342|Other|2 automated messages|Parents of eligible patients will receive 2 HIPAA compliant automated call or text reminders (based on preference recorded in EHR) that their child is due for a checkup and information on how to schedule an appointment.
15785695|NCT04567342|Other|No personal contact attempt|No personal contact attempts will be made.
15785696|NCT04567342|Other|1 personal contact attempt|Parents of eligible patients will receive a text from a medical assistant informing them that their child is due for a check up. This will be followed by personal call from the medical assistant to assist the parent with scheduling an appointment.
15785697|NCT04567329|Drug|NOV03|100% perfluorohexyloctane
15785698|NCT04567329|Drug|Saline Solution|0.6% sodium chloride solution
15785699|NCT04567316|Drug|[14C]-radiolabelled BI 1358894|Part 1
15785700|NCT04567316|Drug|BI 1358894|Part 2
15785701|NCT04567303|Drug|RO7250284|"Part 1: multiple ascending doses by intravitreal injection. Each participant will receive RO7250284 at a constant volume of 50 microliter in the study eye.
~Part 2: participants will be randomized to one of two dose levels of RO7250284 in the PDS implant."
15785704|NCT04567277|Procedure|External ventricular drainage (EVD) conversion into ventriculo-peritoneal shunt (VPS)|EVD in high grade SAH patients were converted into VPS with 7-10 days of EVD insertion
15785705|NCT04567264|Device|StimRouter®, Self-activated and self-controlled neuromodulation device (Bioness Inc, CE0086).|"Regimen 1 (weeks 0-12): one stimulation every 2 days, for a duration of 30 minutes each.
~Regimen 2 (weeks 12-24): Three stimulation treatments per week, for a duration of 30 minutes each."
15785706|NCT04567251|Drug|Namzaric®|"Namzaric® will be given for 17 weeks using the following dosing schedule:
~7 mg memantine hydrochloride and 10 mg donepezil hydrochloride for 1 week, 14 mg memantine hydrochloride and 10 mg donepezil hydrochloride for 1 week, 21 mg memantine hydrochloride and 10 mg donepezil hydrochloride for 1 week, 28 mg memantine hydrochloride and 10 mg donepezil hydrochloride for 12 weeks, 14 mg memantine hydrochloride and 10 mg donepezil hydrochloride for 1 week, 7 mg memantine hydrochloride and 10 mg donepezil hydrochloride for 1 week."
15785707|NCT04567251|Drug|Placebo|Placebo drug, which will look identical to commercial Namzaric®, will be given for 17 weeks including a 3 week dose-escalation, 12 week maintenance period, and 2 week taper.
15785708|NCT04567238|Behavioral|Mobile contingency management|Mobile contingency management is a mobile-phone based behavioral therapy that provides positive reinforcement (i.e., money) for abstinence that is highly effective at reducing substance use.
15785709|NCT04567225|Drug|Glargine|A dose of insulin glargine, 0.4 unit/kg, will be given within 4 hours from initiating the IV Insulin Infusion
15785710|NCT04567225|Drug|Glargine|A historical retrospective control group for the adult patients admitted to the same ICU with a diagnosis of DKA and received insulin glargine after anion gap closure.
15785711|NCT04567225|Other|IV insulin infusion|Continuous weight based IV insulin infusion as per Cleveland Clinic DKA Protocol
15785712|NCT04567225|Other|IV fluid and electrolytes replacement|The IV fluid and electrolytes replacement will be left to the treating physician's discretion. IV fluid to contain dextrose to keep Target Blood Glucose 150 - 200 mg/dl during the DKA management and 140 - 180 mg/dl after DKA resolution.
15785713|NCT04567212|Genetic|genetic evaluation|A sampe of blood (3 mL) and of oral mucosa will be take and analyzed using nCounter GX Human Inflammation Kit a comprehensive number of 8SNPs in 3 human genes known to be differentially expressed in allergic asthma.
15785714|NCT04567212|Other|MicroRNA evaluation|Using the sampe of blood (3 mL) using RT-PCR we will evaluate the expression of microRNA in enrolled patients
15785715|NCT04567199|Other|Observational, retrospective|retrospective analysis of observed results, for both study groups.
15785716|NCT04567173|Drug|Anti-SARS-CoV-2 convalescent plasma|convalescent plasma derived from whole blood donors or standard pheresis from a volunteer who recovered from COVID-19
15785717|NCT04567160|Drug|Propofol|"In the propofol group, general anesthesia will be induced using target-controlled infusion (TCI) of propofol and remifentanil. Marsh pharmacokinetic model will be used to set the initial target predicted effect-site concentration of propofol at 3.0 mcg/ml in flash mode. Simultaneously, target-controlled infusion of remifentanil will be started to reach an initial target predicted effect-site concentration of 3 ng/mL using the Minto pharmacokinetic model.
~After tracheal intubation, TCI of remifentanil is paused."
15785718|NCT04567160|Drug|Sevoflurane|In the sevoflurane group, induction of general anesthesia will be carried out by spontaneous breathing through a mask while progressively opening up the dial of the sevoflurane vaporizer up to 8%. Like in the propofol group, target-controlled infusion of remifentanil is simultaneously started to reach an initial target predicted effect-site concentration of 3 ng/mL. Vaporizer is adjusted when gas equilibration reaches the patient-specific concentration 1.0 MAC of sevoflurane. After tracheal intubation, TCI of remifentanil is paused.
15785719|NCT04567147|Dietary Supplement|Probiotic|Patients received the formula probiotic for consecutive 8 weeks ( one sachet per day ).
15785720|NCT04567147|Dietary Supplement|Placebo|Patients received the placebo identical to probiotic for consecutive 8 weeks ( one sachet per day ).
15785721|NCT04567121|Behavioral|Intensive intervention group|Establish a team of chronic disease prevention managers (5 people), with each educator responsible for the intervention of 200 people. For sub-health population and chronic disease patients, there would be conducted health education interview twice, 4 calls, online communication 50 times once a year, controlling risk factors and making treatment plan.
15785722|NCT04567121|Behavioral|standard intervention group|Conduct general health education without active management
15785723|NCT04567108|Behavioral|Maintain SSBs (Control)|Instruction/guidelines to maintain baseline intake of SSBs; select from approved beverages for a monthly at-home delivery; engage with a motivational mobile app to track beverage intake
15785724|NCT04567108|Behavioral|Substitute Aspartame ASBs|Instruction/guidelines to eliminate SSBs and replace, where possible with beverages artificially sweetened with aspartame; select from approved beverages for a monthly at-home delivery; engage with a motivational mobile app to track beverage intake
15785725|NCT04567108|Behavioral|Substitute Sucralose ASBs|Instruction/guidelines to eliminate SSBs and replace, where possible with beverages artificially sweetened with sucralose; select from approved beverages for a monthly at-home delivery; engage with a motivational mobile app to track beverage intake
15785726|NCT04567108|Behavioral|Substitute Water|Instruction/guidelines to eliminate SSBs and replace with water; select from approved beverages for a monthly at-home delivery; engage with a motivational mobile app to track beverage intake
15785727|NCT04567082|Diagnostic Test|Examination of saliva|Collection of saliva samples
15785728|NCT04567069|Biological|DC vaccine|"Blood samples will be collected twice, 60-120ml/ time. The 1st collection will occur 5 days before the 1st DC vaccine injection, the 2nd collection will occur 15 days after the 1st injection.
~Six subcutaneous(ih) injections of DC vaccine will be given at days 1, 8, 15, 21, 28, 35; 1-3×106 cells/time.
~Injection site: inguinal lymph nodes."
15785729|NCT04567069|Biological|CTL|Four intravenous (iv) drip injections of CTL will be given at days 7, 9, 27, 29; 1-2×109 cells/time.
15785730|NCT04567069|Drug|Sintilimab Injection|The Sintilimab Injection (3mg/kg) will be administered by intravenous (iv) drip injection at days 0, 20。
15785731|NCT04567056|Diagnostic Test|Blood sample|A separate blood sample will be taken for methylation-analyses
15785759|NCT04566900|Other|Placebo|Subjects in this arm will undergo all of the same testing as active treatment. Music and video progression will not depend on brain activity. Instead feedback will be random.
15785760|NCT04566887|Drug|Acalabrutinib|Administered as 100mg tablets.
15785732|NCT04567043|Behavioral|MORE+JITAI|Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention that unites mindfulness training, cognitive reappraisal, and positive psychological principles into an integrative intervention strategy targeting mechanisms of pain and opioid misuse. JITAI involves stress-triggered reminders to practice mindfulness skills.
15785733|NCT04567043|Behavioral|Supporive Psychotherapy|A supportive psychotherapy group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.
15785734|NCT04567030|Device|Dental monitoring (DM)|DM is the first APP system used in orthopedics patients in the world,it has been widely used in Asian countries (Taiwan, Hong Kong, Singapore, Japan, etc.) and has been used by 2140 patients so far. DM allows patients to take in-mouth photos at home, and uses AI as a background analysis to evaluate the patient's current oral condition (including oral hygiene and gum status) based on the photo.
15785735|NCT04567004|Other|Control|Participants will be shown images of juice, bread, yogurt, cookies, and cereal without any added front-of-package labels.
15785736|NCT04567004|Other|Nutriscore Label|A front-of-package Nutriscore label will be applied to images of juice, bread, yogurt, cookies, and cereal. This label applies a score of A, B, C, D, or E based on the product's nutrition profile.
15785737|NCT04567004|Other|Adapted Peruvian Nutrient Label|A front-of-package octagonal nutrient label will be applied to images of juice, bread, yogurt, cookies, and cereal. The label text informs consumers if a product is high in sugar, saturated fat, or salt/sodium. These labels were developed by the Peruvian government and adapted by investigators.
15785738|NCT04567004|Other|Guideline Daily Amount Label|A front-of-package Guideline Daily Amount label will be applied to images of juice, bread, yogurt, cookies, and cereal. The label shows the amount and percent of daily value of calories, total fat, saturated fat, sugar, and sodium in one serving of a product.
15785739|NCT04566991|Drug|Deferoxamine|"There will be 3 doses given to the patients days 1-3. Dose will be given intravenous with a fixed rate of 7.5 milligram per kilogram per hour (mg/kg/hr). The second dose will be given 24 hours after the first dose, and the third dose will be given 48 hours after the initial dose.
~Patients will be randomized to 32 mg/kg or 48 mg/kg of Deferoxamine."
15785740|NCT04566991|Drug|Placebo|There will be 3 doses given to the patients days 1-3. Dose will be given intravenous with a fixed rate of 7.5 mg/kg/hr. The second dose will be given 24 hours after the first dose, and the third dose will be given 48 hours after the initial dose.
15785741|NCT04566978|Drug|89Zr-DFO-REGN3767|89Zr-DFO-REGN3767 is comprised of the anti-LAG-3 antibody, REGN3767 labeled with the positron-emitter zirconium-89 (89Zr) through the chelator-linker DFO. REGN3767 is an investigational monoclonal antibody that target LAG-3 receptors.
15785742|NCT04566978|Diagnostic Test|PET/CT|"A PET/CT scan extending from top of skull to feet will be performed to determine the biodistribution.
~Part A patients will be imaged at three time points post-injection to allow for selection of optimal imaging time and dosimetry determination. For these patients, top of skull to feet scans will be acquired:
~Within one to four hours following injection of tracer on Day 1
~24-72 hours post-injection (Day 2-4)
~20-168 hours post-injection (once during days 5-7)"
15785743|NCT04566965|Diagnostic Test|SARS-CoV-2|"Testing weekly samples from nasal swabs to promptly diagnose acute COVID-19 infection.
~Testing monthly serum samples to document post-viral infection."
15785744|NCT04566952|Drug|Anlotinib|Anlotinib will be treated with its minimum dose that is orally 8 mg daily on days 1-14 of a 21-days cycle.
15785745|NCT04566952|Drug|Olaparib|Olaparib will be treated with a total daily dose of 450 or 300mg.
15785746|NCT04566939|Drug|Herbal medicine|Herbal medicine will be administered in water-based decoction (120ml) and dried powder (2g) form (Ostericum koreanum,Eucommia ulmoides, canthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, aposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycinemax, Atractylodes japonica) at the physician's discretion.
15785747|NCT04566939|Procedure|Chuna manual medicine|Chuna is a Korean manual therapy directed at the spine and joints that incorporates various spinal manual medicine techniques for joint mobilization involving high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement. Chuna manual medicine will be administered to the shoulder at the physician's discretion.
15785748|NCT04566939|Procedure|Pharmacopuncture|Pharmacopuncture consisting of select herbal ingredients will be administered at Gyunwoo (LI15), Gyunryo(TE14), Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea) at the physician's discretion.
15785749|NCT04566939|Procedure|Acupuncture|Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
15785750|NCT04566939|Procedure|Electroacupuncture|Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
15785751|NCT04566939|Procedure|Cupping|Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.
15785752|NCT04566939|Procedure|Herbal hot pack|Herbal hot pack treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
15785753|NCT04566939|Procedure|Physical therapy|The participants in the control group will be receive one or more physical therapy according to the physician's decision.
15785754|NCT04566939|Procedure|Other intervention(s)|Patients will be allowed any other additional intervention(s) as deemed necessary regardless of type or dose, and patterns of use will be investigated and recorded as a pragmatic clinical study.
15785755|NCT04566926|Drug|JNJ-64140284|Participant will receive JNJ-64140284 formulation 1 or 2 under fasting or fed condition.
15785756|NCT04566926|Drug|Placebo|Participant will receive matching placebo.
15785757|NCT04566913|Procedure|Pontic Shield Technique|• Together the apical and the palatal portions of the root in the esthetic region will be delivered and the buccal part is left for assessment of stability of bucco-palatal dimension of alveolar ridge
15785758|NCT04566900|Behavioral|Neurofeedback|Neurofeedback is a technique where brain functions are made accessible to the subject in the form of a metaphor. For instance, frontal brain activity may be shown as an airplane flying. Once the activity is made accessible, the subject can modulate it in a pre-specified direction. The parameters used to achieve successful feedback are made difficult over time and hence the brain is taught or conditioned to improve performance.
15785761|NCT04566887|Drug|R-CHOP chemotherapy|R-CHOP chemotherapy
15785763|NCT04566861|Behavioral|Cognitive Behavioral Therapy (CBT) for anxiety during pregnancy|Women who are randomized to the intervention group will receive six core Cognitive Behavioral Therapy (CBT) sessions for anxiety during pregnancy (and possible booster sessions) to treat symptoms of anxiety.
15785764|NCT04566848|Diagnostic Test|Flow cytometric analysis|Measuring the sCD25 (IL-2Ra), 4-1BB, B7.2 (CD86), Free Active TGF-β1, CTLA-4, PD-L1, PD-1, Tim-3, LAG-3, Galectin-9 levels with flow cytometry
15785765|NCT04566835|Other|Standart Care given during normal examination|This is the standart education given by doctor. The child and his/her parents come to the doctor for normal examination. They take their asthma diagnosis or other information about their condition. and then the doctor explain them about what is asthma, what are the drugs or how should they use them. This is the implementation using for the control group.
15785766|NCT04566835|Behavioral|Health Promotion Program with cartoon education for Children with Asthma|First of all, the child and their parents take the routine examination as the same as the control group. Then they take the experimental education called Health Promotion Program with cartoon education for Children with Asthma. The children with asthma were educated within the scope of the program in order to demonstrate the effect of the program on asthma management. Children with asthma were educated with the program, which consisted of 4 units, each of 10 minutes, prepared in the light of the literature and with the current guidelines. Each child received the education in a total of 40 minutes. Every unit has its own cartoon video and comic book material. To sum up The Principal Investigator first give the education about asthma management, then makes them watch the Iggy and the Inhalers videos developed for each unit, and does a colouring activity with comic books at the end of each unit.
15785767|NCT04566822|Behavioral|High Touch intervention|The Calm app is downloadable by participants onto their smartphone to access the Calm app and Calm Sleep Coaching. The Calm app is used to deliver the intervention to experimental group participants.
15785768|NCT04566822|Behavioral|Medium Touch intervention|The Calm app is downloadable by participants onto their smartphone to access the Calm app and Calm Sleep Coaching. The Calm app is used to deliver the intervention to experimental group participants.
15785769|NCT04566822|Behavioral|Low Touch intervention|The Calm app is downloadable by participants onto their smartphone to access the Calm app and Calm Sleep Coaching. The Calm app is used to deliver the intervention to experimental group participants.
15785770|NCT04566822|Behavioral|Sleep Education Control|Participants in the sleep education control will not have access to a coach. Weekly sleep education will be accessible to the participant on a weekly basis. The sleep education content will be the same that is provided to the intervention participants.
15785771|NCT04566809|Other|FES+CBA|The experimental treatment was formerly composed by 20 sessions of FES for the hand in combination with a structured cognitive therapy
15785772|NCT04566809|Other|FES|The control treatment was formerly composed by 20 sessions of FES for the hand
15785773|NCT04566796|Drug|Sugammadex|give 2 mg/ kg as muscle reversal drug in premature infants
15785774|NCT04566796|Drug|Neostigmine|give 0.02 mg/ kg atropine and 0.05 mg/kg neostigmine IV. as muscle reversal drug in premature infants
15785775|NCT04566783|Diagnostic Test|Psychological/psychiatric examination|Thorough diagnostic and (neuro)psychological assessment using standardized clinical interviews (e.g. MINI, SOMS) as well as questionnaires assessing sexual function (e.g. SIS/SES), depression and anxiety (HADS), childhood trauma (CTQ) and life quality (WHOQOL-BREF). In a semi-structured interview sociodemographic data, drug history and sexual characteristics are captured.
15785776|NCT04566783|Diagnostic Test|Neurological examination|Standardized clinical neurological examination as well as neurophysiological measurements (Pudenus-SEP, ENoG, clinical EEG).
15785777|NCT04566783|Diagnostic Test|Gynecological/urological examination|Standard clinical investigation including ultrasound of the genital organs will be conducted to look for any somatic pathology (e.g. varices, tumors).
15785778|NCT04566783|Diagnostic Test|Laboratory assessment|Blood sample will be analyzed to evaluate (epi-)genetic markers of increased central excitability or decreased inhibition including specific parameters of the serotonin-, dopamine- and endocannabinoid system.
15785779|NCT04566783|Diagnostic Test|Structural and Functional Magnetic Resonance Imaging|"Structural MRI of the pelvis is conducted to rule out any anatomical pathologies underlying PGAD (e.g. varices).
~Structural MRI of the lumbosacral spinal cord to look for any pathologies on the spinal level, especially spinal level S2-4 (e.g. Tarlov cysts).
~High-resolution structural MRI (T1) including brain stem will be applied to all participants in order to explore alterations in gray matter volume or density.
~Structural differences in white matter will be assessed using a high-resolution DTI sequence. In addition to standard voxel-wise comparison of DTI derived parameters for white matter microstructural integrity, a tractography-based analysis will test for alterations in structural connectivity.
~Resting-state functional MRI including brain stem scans will evaluate abnormal brain circuitry at rest (resting-state functional connectivity, RSFC).
~Functional MRI to assess brain response towards sexual cue reactivity."
15785780|NCT04566770|Biological|Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)|Intramuscular other name:Ad5-nCoV
15785781|NCT04566770|Biological|Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) -placebo|Intramuscular other name:Ad5-nCoV
15785782|NCT04566757|Biological|Umbilical Cord Blood Plasma|Intravenous Infusion of Umbilical Cord Blood Plasma
15785783|NCT04566744|Other|fRMI|The measurements performed will be the participant's brain activity, as well as behavioral measurements associated with the tasks performed (response time, correctness of the response). Brain activity measurements will be performed on the Siemens 3T system of the MRI department of CERMEP. The subject will perform the task under study while the level of brain activity is recorded. The functional examination will be subdivided into several parts according to its total length in order to spare the subject. The total duration of MRI acquisitions will be approximately 1 hour regardless of the axis.
15785784|NCT04566731|Device|Transcranial Direct Current Stimulation (tDCS)|tDCS is a type of non-invasive brain stimulation in which small electrical currents are applied to the scalp via 2 electrodes. The current, 1.5 mA, is approximately of the same intensity as the current provided by a 9-volt battery. To deliver the current, electrodes that are placed in saline soaked sponges. They will be attached to the left side of your head; they will be held in place with an elastic cap. For both real and sham stimulation the electrodes will be placed on the scalp.
15785826|NCT04566432|Other|Observation|observe the association of ctDNA with efficacy of treatment
15785828|NCT04566419|Other|Oxygen|oxygen delivered by Venturi mask
15785785|NCT04566731|Device|Sham tDCS|tDCS is a type of non-invasive brain stimulation in which small electrical currents are applied to the scalp via 2 electrodes. During sham stimulation, the current, 1.5 mA, will be delivered for a short amount of time and then turn-off. To deliver the current, electrodes that are placed in saline soaked sponges. They will be attached to the left side of your head; they will be held in place with an elastic cap. For both real and sham stimulation the electrodes will be placed on the scalp. Most people cannot tell the difference between real and sham stimulation.
15785786|NCT04566731|Behavioral|Modified Contraint-Induced Language Therapy (mCILT)|Modified constraint-induced language therapy (mCILT) is a behavioral language therapy that invokes use-dependent learning in communicative interactions by requiring spoken output and restricting use of alternative forms of communication, such as gestures, as a substitute for spoken output. Other key elements of CILT include massed practice of goal-directed speech and shaping of desired responses by increasing response demands as participants improve. MCILT differs from traditional constraint-induced language therapy (CILT) in three ways: 1) it will be done as an individual therapy with the examiner in the role of a communication partner; 2) treatment will be delivered in short sessions (1 hour rather than a more typical 3-4 hour session); 3) targeting nouns + semantically related verbs to generate noun + verb phrases in treatment, a modification that may be better suited to addressing syntactic structure.
15785787|NCT04566718|Drug|Metformin|metformin cessation
15785788|NCT04566705|Other|Risks factors, maternal and neonatal outcomes/complications|Risks factors, maternal and neonatal outcomes/complications
15785789|NCT04566692|Biological|IGSC 20%|Subcutaneous (SC) infusion pump.
15785790|NCT04566679|Dietary Supplement|Dibuzin|2-week run-in phase (weeks 1-2) followed by 8-week treatment period (weeks 3-10) and 4-week follow-up phase (weeks 11-14)
15785791|NCT04566679|Dietary Supplement|placebo|2-week run-in phase (weeks 1-2) followed by 8-week treatment period (weeks 3-10) and 4-week follow-up phase (weeks 11-14)
15785792|NCT04566666|Drug|Placebo|Placebo of SCD-044 product
15785793|NCT04566666|Drug|SCD-044_Dose 1|SCD-044 tablets in Dose 1.
15785794|NCT04566666|Drug|SCD-044_Dose 2|SCD-044 tablets in Dose 2
15785795|NCT04566666|Drug|SCD-044_Dose 3|SCD-044 in Dose 3
15785796|NCT04566653|Drug|Calcium Polystyrene Sulphonate 15g/60 mL water|K+ binder, not for treatment but for tasting (sip-and-spit taste test)
15785797|NCT04566653|Drug|Lokelma® 5 g/45mL water|K+ binder, not for treatment but for tasting (sip-and-spit taste test)
15785798|NCT04566653|Drug|Lokelma® 10 g/45 mL water|K+ binder, not for treatment but for tasting (sip-and-spit taste test)
15785799|NCT04566653|Drug|Veltassa® 8,4 g/80mL water|K+ binder, not for treatment but for tasting (sip-and-spit taste test)
15785800|NCT04566653|Drug|Sodium Polystyrene Sulphonate 15g/60 mL water|K+ binder, not for treatment but for tasting (sip-and-spit taste test)
15785801|NCT04566627|Behavioral|"Yo Sé Lo Que Quiero programl"|"Yo Sé Lo Que Quiero program is the cultural adaptation of the Unplugged program. This is a preventive intervention to reduce tobacco, alcohol, and marihuana use among adolescents. It consists of 12 sessions, delivered by a trained facilitator on a weekly basis."
15785802|NCT04566614|Other|ctDNA blood sampling|Screening/baseline blood sample to be analysed for ctDNA
15785805|NCT04566588|Procedure|EAR HoLEP|early apical release holmium enucleation of the prostate (EAR HoLEP), as a surgical treatment for benign prostatic hyperplasia
15785806|NCT04566588|Procedure|Classic HoLEP|classic holmium enucleation of the prostate as a surgical treatment for benign prostatic hyperplasia
15785807|NCT04566575|Other|trans vaginal ultrasound (TVUS)|In the TVUS, the residual myometrium is determined after surgery and the appearance of new cysts in the area of the caesarian section scar is assessed.
15785808|NCT04566575|Other|patient questionnaire|exploratory patient questionnaire regarding satisfaction after correction of isthmocele
15785809|NCT04566562|Diagnostic Test|Brain Imaging|Magnetic Resonance Imaging (MRI) using diffusion weighted pseudo-continuous arterial spin labeling (DW-pCASL) .
15785810|NCT04566562|Diagnostic Test|Cognitive Testing|Wide Range Assessment of Memory and Learning (WRAML 2) and Montreal Cognitive Assessment (MoCA)
15785811|NCT04566562|Diagnostic Test|Blood Biomarkers|Inflammatory Markers
15785812|NCT04566549|Combination Product|Test group Probiotic Shampoo|Probiotic Shampoo
15785813|NCT04566549|Combination Product|Placebo group|Shampoo base
15785814|NCT04566523|Other|telerehabilitation|Patients undergo an online exercise training program via a certified host of health data website.
15785815|NCT04566510|Other|long lasting insecticidal nets with alpha-cypermethrin + pyriproxyfen (PPF LLIN, Royal Guard))|Next-generation bed net combining insecticides with different modes of action
15785816|NCT04566510|Other|long lasting insecticidal nets with deltamethrin + piperonyl butoxide (PBO LLIN, PermaNet 3.0))|Next-generation bed net combining an insecticide with a synergist
15785817|NCT04566510|Behavioral|Social behaviour change communication|SBCC activities will use digital and other platforms, similar to those used for the COVID-19 response, including the following: (1) LLIN launch on television and radio; (2) regional advocacy meetings on Zoom; (3) mass media platforms (for advertisements, mini skits, DJ mentions, radio spots, interactive talks); (4) social media platforms; (5) VHTs; (6) operation hotlines and toll-free call centres; (7) community mobilisation (megaphones); and (8) use of appropriate information, education, and communication materials. Communication will include messages about COVID-19, malaria, and use, care, repair and repurposing of LLINs.
15785818|NCT04566497|Other|No stress testing|No stress testing during the patient follow up (up to 48 months) if the patient remains asymptomatic
15785819|NCT04566497|Procedure|stress testing|Systematic annual stress testing during the patient follow up (up to 48 months)
15785820|NCT04566484|Drug|BBV87 Chikungunya vaccine|BBV87 Chikungunya vaccine is a whole virus inactivated vaccine formulated with 0.25 mg aluminum (as aluminum hydroxide) per single human dose.
15785821|NCT04566484|Drug|Normal Saline|Normal saline is the placebo
15785822|NCT04566471|Other|prevalence/incidence|It is an observational study for prevalence/incidence, no intervention provided.
15785823|NCT04566458|Other|No intervention|retrospective chart review study
15785824|NCT04566445|Drug|GT005: Medium Dose|The study will test two doses of GT005: Medium Dose and High Dose.
15785829|NCT04566406|Procedure|Laparoscopic adrenalectomy|Preoperative staging in all cases consisted of computed tomography or/and magnetic resonance imaging. Prior to surgery, a routine panel of laboratory tests was carried out. The catecholamines metabolites (metanephrine, normetanephrine, and methoxytyramine) were measured from 24-hour urine collection. All patients were preoperatively treated with phenoxybenzamine or alternative doxazosin.Additionally, beta-blockers in case of coexisting tachycardia were given. In the morning of the operation, preinduction blood pressure was measured. Pneumoperitoneum was achieved by insufflating CO2 gas to an intraperitoneal pressure of 12 mmHg. The operative method in our department was laparoscopic transperitoneal lateral total adrenalectomy. Intraoperatively SBP and diastolic blood pressure (DBP) were measured and recorded every 10 minutes. To treat hypertensive and hypotensive episodes, intravenous doses of urapidil, ephedrine, nitrates, MgSO4, norepinephrine, or ß-blockers were administered.
15785830|NCT04566393|Drug|Ulixertinib (BVD-523)|Ulixertinib (BVD-523) is an oral, first-in-class ERK1/2 inhibitor
15785831|NCT04566380|Drug|ONO-4538|IV infusion over 30 minutes
15785832|NCT04566367|Diagnostic Test|blue laser imaging|The intervention is the push on demand activation of blue laser imaging technique during gastroscopy.
15785833|NCT04566354|Other|Repeated 30-s sprint exercise|Analyze of Interleukin-6 concentration before and after repeated 30-s sprint exercise
15785834|NCT04566341|Device|OCT - TCE|Participants will be asked to swallow the TCE. They may use mild numbing spray, and lubrication spray to help swallowing. Imaging will be conducted once the TCE is past the pharynx. We will advance the TCE until the stomach and then slowly pull the TCE back up the esophagus. This may be repeated twice.
15785835|NCT04566328|Drug|Bortezomib|Given SC
15785836|NCT04566328|Biological|Daratumumab and Hyaluronidase-fihj|Given SC
15785837|NCT04566328|Drug|Dexamethasone|Given PO
15785838|NCT04566328|Drug|Lenalidomide|Given PO
15785839|NCT04566328|Other|Quality-of-Life Assessment|Ancillary studies
15785840|NCT04566315|Procedure|Arteriography knee arteriography|arteriography and an injection of inert microparticles of 75 μm in neovessels
15785841|NCT04566302|Device|SECM Skin Imaging|Consented Participants will be asked to allow their forearm to be imaged by the dermatoscope on the same skin/lesions as a control comparison. We will be trying to image pigmented skin/lesions present on the forearm. This will be followed by imaging using the SECM Skin imaging device
15785842|NCT04566289|Device|PiCSO|Percutaneous coronary intervention
15785843|NCT04566276|Biological|ChulaCov19 vaccine|SARS-Cov2 Wild-type S-spike mRNA/ lipid nanoparticle (LNP) vaccine
15785844|NCT04566276|Other|Placebo|Saline
15785845|NCT04566263|Device|Neuroform EZ Stent System|The Stryker Neuroform EZ Stent System is a self-expanding nitinol, compliant, open-cell design that can be deployed by a single operator. The Neuroform EZ Stent System is packaged sterile as a single unit with an introducer sheath and a detachable push wire.
15785846|NCT04566250|Combination Product|Non-Opioid Prescription and Infographic|"The study intervention will involve 3 components:
~A standardized non-opioid prescription: A prescription for Naproxen 500mg PO BID PRN x 60 tabs, Acetaminophen 1000mg PO Q6H PRN x 100 500mg tabs and Pantoprazole 40mg PO daily x 30 tabs (to be taken only while utilizing Naproxen).
~A limited opioid rescue prescription: A prescription of Hydromorphone 1mg PO Q4H PRN x 10 tabs will be included on a separate prescription.
~Patient education infographic: The infographic will contain information on how to take the prescribed medications, along with instructions that the morphine rescue prescription should only be used in cases where the non-opioid pain medications are not providing satisfactory pain control."
15785847|NCT04566237|Procedure|Objective Scatter Index (OSI)|On Optical Quality Analysis System (OQAS) device. At Inclusion, 3 months, 12 months and 24 months after vitrectomy
15785848|NCT04566237|Procedure|Average Lens Density (ALD)|on IOLMaster® 700 device. At Inclusion, 3 months, 12 months and 24 months after vitrectomy
15785849|NCT04566224|Device|Macintosh size 2 blade|intubate with Macintosh size 2 blade
15785850|NCT04566224|Device|Macintosh size 3 blade|intubate with Macintosh size 3 blade
15785851|NCT04566211|Drug|(panto+amox+clar+metr)+(panto+amox)|a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 3-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily
15785852|NCT04566211|Drug|pantoprazole+bismuth+amox+clar|pantoprazole 40 mg twice daily, bismuth subcitrate 240 mg twice daily, and amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily for 10 days
15785853|NCT04566198|Other|Questionnaire|The participants will have to filled out a questionnaire about their working conditions and their lifestyle habits.
15785857|NCT04566172|Behavioral|Inspiratory Muscle Training (IMT)|Participants will receive an inspiratory muscle training that they will do leading up to the day of their surgery.
15785948|NCT04565353|Behavioral|Flu shot text messages|Participants will receive text messages per descriptions listed in the arms.
15785858|NCT04566159|Behavioral|CBI-CHW|2 sessions of computer delivered counseling + nicotine replacement therapy and CHW follow up post hospitalization up to twice weekly for up to 8 weeks
15785859|NCT04566159|Other|Standard Care|Standard tobacco treatment care offered by the inpatient care
15785860|NCT04566146|Other|scapular muscle training, serratus anterior strength, scapular stabilization exercises|patients will be scheduled to attend physical therapy three sessions per week for one month. Three sets of 10 repetitions for each exercise were prescribed per session, with a 1-minute rest between sets.
15785863|NCT04566120|Drug|cinnamon extract mouthwash|cinnamon extract mouthwash
15785864|NCT04566120|Drug|chlorohexidine based mouthwash|chlorohexidine based mouthwash
15785865|NCT04566107|Behavioral|mHealth intervention|The intervention promotes self-management and adherence to treatment regimens in patients with multimorbidity. This 8-week SM intervention uses mobile health (m-Health) technology for daily messages and reminders to promote self-monitoring activities. Bluetooth devices provided will depend on the participant's need for self-management; heart failure (scale), diabetes (glucometer), COPD (pulse oximeter) or hypertension (BP machine).
15785866|NCT04566107|Behavioral|mHealth Plus|The intervention promotes self-management and adherence to treatment regimens in patients with multimorbidity. This 8-week SM intervention uses tailored self-management strategies (action planning, goal setting, and individual identified support needs) and mobile health (m-Health) technology for virtual visits, daily messages, and self-monitoring activities. The investigators will test the additive impact of having the nurse practitioner/community health worker (NP/CHW) team with the m-health platform. The NP will evaluate physiological and psychosocial status while the CHW will assist in recognizing possible solutions to challenging social determinants of health by identifying community resources and guidance in overcoming barriers. Bluetooth devices provided will depend on the participant's need for self-management; heart failure (scale), diabetes (glucometer), COPD (pulse oximeter) or hypertension (BP machine). Participants will receive reminders through the platform.
15785867|NCT04566081|Other|iTALKbetter: deterministic|A word retrieval therapy application
15785868|NCT04566081|Other|iTALKbetter: reactive|A word retrieval therapy application
15785869|NCT04566068|Behavioral|Intervention- Adapted Virtual Insomnia Program|4 sessions (approximately 45 min/each, weekly) plus 3 check-ins (approximately 15 min/each, between-sessions) delivered virtually. Sessions are modeled after a published, evidence-based CBT-I protocol and adapted to target needs and preferences identified by cancer survivors.
15785870|NCT04566068|Behavioral|Control- Enhanced usual care|Enhanced usual care. Referral to the Massachusetts General Hospital Behavioral Sleep Medicine service plus an educational handout on the topic of sleep hygiene.
15785871|NCT04566055|Device|AlloSure|Patients will receive donor-derived cell-free DNA testing for surveillance and for-cause.
15785872|NCT04566042|Behavioral|Acceptance and commitment therapy video game|The intervention is a videogame which teaches the participant about acceptance and commitment therapy.
15785876|NCT04566016|Procedure|Regional anesthesia|Patients scheduled for lower limb arterial bypass surgery will be randomly allocated for treatment with spinal anesthesia associated with spontaneous ventilation (nasal cannula with supplemental oxygen - Group 1) or treatment with general anesthesia under controlled mechanical ventilation (tidal volume 6 to 8 ml / kg of the predicted body weight and PEEP of 5 cmH2O - Group 2).
15785880|NCT04565977|Other|Observational|Retrospective chart review
15785881|NCT04565964|Other|change the health behaviors to clean indoor environment|Sheets and all covers should be wash weekly. Clean indoor environment with a vacuum cleaner twice a week
15785882|NCT04565951|Behavioral|PsychArmor S.A.V.E.|The intervention is called PsychArmor S.A.V.E. It is an online video-based training tailored to veterans and their close supports. It is free, brief (24 minutes), and includes three scripted role plays.
15785883|NCT04565951|Behavioral|sham intervention|"A sham training consisting of information unrelated to suicide prevention but relevant to transitioning veterans and their loved ones."
15785884|NCT04565938|Procedure|Application of adhesive for the restoration of dental lesions with resin composite|"Mechanical removal of sclerotic dentin with a round bur
~Enamel beveling
~Enamel (30sec) and dentin (15sec) etching with phosphoric acid
~Application of ExciTE (Ivoclar/Vivadent, AG, Shaan, Lichtenstein) and curing for 10sec with 800mW/cm2 light intensity (Cure TC-01, Spring Health Products, Inc, Norristown, PA, USA)
~Composite-resin application using a transparent cervical matrix (Kerr-Hawe, Orange, CA, USA) and curing for 40sec
~Finishing and polishing"
15785885|NCT04565938|Procedure|Application of adhesive for the restoration of dental lesions with resin composite|"Mechanical removal of sclerotic dentin with a round bur
~Enamel beveling
~Application of AdheSE One (Ivoclar/Vivadent, AG, Shaan, Lichtenstein) and curing for 10sec
~Composite-resin application using a transparent cervical matrix and curing for 40sec
~Finishing and polishing"
15785886|NCT04565938|Procedure|Application of adhesive for the restoration of dental lesions with resin composite|"Mechanical removal of sclerotic dentin with a round bur
~Enamel beveling
~Enamel (30sec) etching with phosphoric acid
~Application of AdheSE One and curing for 10sec
~Composite-resin application using a transparent cervical matrix and curing for 40sec
~Finishing and polishing"
15785887|NCT04565925|Drug|Sildenafil Citrate|Sildenafil 20mg TID for 4 weeks
15785888|NCT04565925|Drug|Placebo|Placebo (Lactose) TID for 4 weeks
15785889|NCT04565912|Drug|Sage extract mouthwash|Patients will be exposed to sage extract mouthwash and will be instructed to use 10 ml of sage extract mouthwash 2 times per day for 1 minute, such a regimen will be continued for one month.
15785890|NCT04565912|Drug|Chlorohexidine based mouthwash|Patients will be exposed to Chlorohexidine based mouthwash , and will be instructed to use 10 ml of 0.12% chlorohexidine based mouthwash 2 times per day for 1 minute, such a regimen will be continued for one month
15785891|NCT04565899|Other|Practice facilitation implementation intervention|6 months during which practice facilitation is implemented to support the primary care clinic in improving routine, population-based screening, assessment, treatment, and follow-up for unhealthy alcohol use and AUDs.
15785892|NCT04565899|Other|Usual care|Care received before active implementation begins, which includes passive access to tools in the EHR.
15785893|NCT04565886|Device|Diode laser application|After mechanical debridement, the pockets around the implant will be rinsed with sterile saline solution. Adjunctive diode laser (settings: 810 nm, 2.5 W, 50 Hz, 10 ms) will be applied 3x for 30 s (i.e., 90 s per appointment) using a 400-lm thick fiber (WhiteStar, Orcos Medical AG, Küsnacht, Switzerland) in the test group. In the control group, non-activated (= placebo) adjunctive diode laser will be applied. The entire treatment procedure, including mechanical debridement, will be performed at Day 0 (= baseline), 7 and 14. The laser decontamination procedure will occur by systematically moving the laser tip along the subgingival implant surface in a vertical and horizontal scanning way. The laser tip will be checked after 4-5 s for coagulation to prevent hotspots in the soft tissues.
15785894|NCT04565886|Device|Sham Diode laser|After mechanical debridement, the pockets around the implant will be rinsed with sterile saline solution. Non-activated (= placebo) adjunctive diode laser will be applied. The entire treatment procedure, including mechanical debridement, will be performed at Day 0 (= baseline), 7 and 14. The laser decontamination procedure will occur by systematically moving the laser tip along the subgingival implant surface in a vertical and horizontal scanning way.
15785895|NCT04565873|Diagnostic Test|TSH|retrospective TSH level
15785896|NCT04565860|Other|Bulk-fill composite resin. (Dental Composite Resin Materials) (Dental filling materials)|"Bulk-fill composites that were introduced in recent years are dental filling materials. Traditionally, the composite resins are placed in increments of 2 mm that are cured separately (incremental technique). Bulk-fill composites can be described as composites that are sufficiently polymerizable in a single layer up to 4 mm thick.
~In this study, each bulk-fill composite resin was used both in bulk-filing and incremental techniques for the same patient. The study set to 4 groups and 20 restorations in each group (a total of 80 restorations)."
15785897|NCT04565847|Drug|Salbutamol 5mg/mL|Nebulized salbutamol given prior to Mannitol-Induced Cough Challenge
15785898|NCT04565847|Drug|Sodium Chloride 0.9% Inhl 3Ml|Nebulized 0.9% saline given prior to Mannitol-Induced Cough Challenge
15785899|NCT04565834|Genetic|Analysis of Single nucleotide polymorphisms in each group.|The 6 single nucleotide polymorphisms (SNPs) determined will then be genotyped according to the Thermofisher Taqman technique ona 480 LightCycler (Roche Applied Science). 10% of the genotypes will be confirmed via Sanger sequencing on a 3500xl Thermofisher sequencer according to the manufacturer's recommendations.
15785900|NCT04565821|Device|IPD Probe via TNIT|A total of 10 healthy adult volunteers will be enrolled in this study. All consented participants will be receive the same intervention. A Nasal tube will be inserted through nares until reaching the small intestine. This will be confirmed by m-mode OCT. Once secured, we will start infusing Ionic solution into the intestine so that IPD Probe can measure the potential difference between this and the control reading. The control reading is measured by infusing the same ionic solution subcutaneously on large muscle groups.
15785901|NCT04565808|Procedure|primary percutaneous coronary intervention|Primary Percutaneous Coronary Intervention (PPCI), also known as angioplasty or coronary angioplasty, is a procedure used to diagnose and treat the narrowed coronary arteries of the heart.
15785902|NCT04565795|Device|Uriprene® Degradable Temporary Ureteral Stent|Assess adequate intervention-free drainage during use and the time to complete degradation or the passage of stent fragments/segments from the urinary system by radiological assessment.
15785903|NCT04565756|Drug|EXN407|EXN407 or placebo will be administered as a single 30 microliters drop twice a day, by unilateral eye drop administration to the study eye only.
15785904|NCT04565743|Behavioral|Support on dentification and treatment of patients with high risk of osteoporotic fractures|Education for primary care health care professionals and referral of patients with recent osteoporotic fracture.
15785905|NCT04565730|Other|Grup I= General anesthesia group|"Preoperative and postoperative evaluation Pre-operative data will be collected 1 to 2 hrs before operation. Preoperative anxiety level will be assessed by the Hospital Anxiety and Depression Scale (HADS) and Amsterdam Preoperative Anxiety and Information Scale.
~Patients will be asked to complete the Edinburgh Postnatal Depression Scale (EPDS) on the morning of discharge, 1 months and 3 months days after delivery. An online survey will be conducted post-Cesarean delivery to investigate the primary outcome of PND using EPDS, and those will not complete the online survey received phone calls to conduct the follow-up surveys."
15785906|NCT04565730|Other|Grup II= Spinal anesthesia group|"Preoperative and postoperative evaluation Pre-operative data will be collected 1 to 2 hrs before operation. Preoperative anxiety level will be assessed by the Hospital Anxiety and Depression Scale (HADS) and Amsterdam Preoperative Anxiety and Information Scale.
~Patients will be asked to complete the Edinburgh Postnatal Depression Scale (EPDS) on the morning of discharge, 1 months and 3 months days after delivery. An online survey will be conducted post-Cesarean delivery to investigate the primary outcome of PND using EPDS, and those will not complete the online survey received phone calls to conduct the follow-up surveys."
15785909|NCT04565704|Device|Biopsy imaged by Optical imaging device.|
15785910|NCT04565691|Procedure|Non-surgical periodontal treatment|Non-surgical periodontal treatment that is accepted to cause bacteremia in about 50% of the cases.
15785911|NCT04565678|Drug|Mitapivat tablets|Oral tablets
15785912|NCT04565678|Drug|Mitapivat coated granules|Oral coated granules
15785915|NCT04565652|Device|Device Wearers|The intervention arm will wear the LOIS ICD Smartband during routine ICD defibrillation following elective ICD implant.
15785916|NCT04565639|Device|Powered Hand Orthosis|A prototype powered hand orthosis system designed to improve grip strength and improve ability to perform tasks of daily living.
15785917|NCT04565626|Other|Additional weekend physiotherapy|Patients randomized to intervention would receive a Medical Exercise Bike Pedal Exerciser Mini Peddler to allow for an additional 20 minutes a day of unsupervised physiotherapy both during the week and on weekends.
15785918|NCT04565613|Dietary Supplement|Enteral protein supplementation|"The participants in the study interventional group will receive protein supplementation to reach a final goal of 1.5 g/kg/day of protein on full feeds. This will be via 100% whey protein isolate (Nestle Beneprotein). Doses will be calculated on the patient's admission weight and rounded up to the nearest 1g. Doses will not be adjusted to account for weight changes in the PICU.
~Protein supplementation will continue for a total of 7 days from the start of enrolment into the study or until PICU discharge, whichever is earlier. If the patient is able to take solid feeds during the study intervention period, the intervention will be stopped. However, if the device required for feeding is removed but the patient takes milk/liquid feeds fully, protein supplementation will continue."
15785919|NCT04565600|Drug|Etoricoxib|Etoricoxib 60 Mg Oral Tablet
15785920|NCT04565587|Other|Xanthan-gum based thickener|Participants will undergo a screening procedure (V-VST) with two of the viscosities levels determined and prepared with mineral water and Tsururinko Quickly (200 and 800mPa·s). After the V-VST, a Videofluoroscopy (VFS) will be performed with thin liquid and 5 viscosity levels prepared with X-Ray contrast (Omnipaque), mineral water and Tsururinko Quickly (100, 200, 400, 800, 1600mPa·s). Participants swallow will be studied with VFS in a lateral projection and images will include the oral cavity, pharynx, larynx and cervical oesophagus. Swallows will be analysed by equipment developed to capture and digitize the swallowing sequences to assess VFS signs of safety and efficacy according to accepted definitions and to measure the timing and spatial events of the swallow response.
15785921|NCT04565574|Drug|E7090|Oral tablet.
15785922|NCT04565574|Drug|Rabeprazole 20 mg|Rabeprazole 20 mg (2 tablets, each of 10 mg) oral tablet.
15785923|NCT04565574|Drug|Rifampin 600 mg|Rifampin 600 mg (4 capsules, each of 150 mg) oral capsule.
15785924|NCT04565561|Device|Neovas BRS or DCB|"All STEMI patients were predilated (including predilated balloon or cutting balloon) before randomization. Thrombus aspiration was determined by the surgeon according to the specific situation.
~Sufficient predilation criteria: the following two conditions must be met: A. residual stenosis < 30%; B. no flow limiting dissection or TIMI grade 2-3."
15785925|NCT04565548|Other|Educational program for hypertensive patients|The theory-guided program consisted of one session of health education, self-developed leaflet, and weekly text messaging for 12 weeks.
15785926|NCT04565548|Other|Usual care|One standardized health education and a leaflet developed by the Health Bureau. As similar as the intervention group, weekly text messaging will be delivered, but the content is not related to the blood pressure control.
15785927|NCT04565535|Behavioral|Novel donor lifestyle optimisation protocol|Diet based on calorie requirement as calculated by indirect calorimetry. Daily exercise.
15785928|NCT04565522|Other|Prospective observation|Prospective observation until one year follow-up
15785929|NCT04565509|Behavioral|General Communication Message|A messaging strategy will be developed from focus groups that generally describes COVID-19 and the importance of testing.
15785930|NCT04565509|Behavioral|Focused/Targeted Message|A messaging strategy that is developed from focus groups that is targeted to address specific concerns of the different communities. Messages may target groups being tested (staff versus students) or sociodemographic or race/ethnicity differences between schools depending on the focus groups input.
15785931|NCT04565509|Behavioral|Best Message Alone|The best message will be either the general or focused/targeted message described above.
15785932|NCT04565509|Behavioral|Best Message + Augmented Message or Implementation Strategy|The augmented messaging and implementation strategies will be informed by the barriers and facilitators identified based on the CFIR domains and results of focus groups and surveys in Aim 2.
15785933|NCT04565496|Drug|Pembrolizumab|Pembrolizumab will be administered at the dose of 200 mg intravenously, every 3 weeks, for a total of 3 cycles prior to RP and ePLND
15785935|NCT04565470|Other|online questionnaire|Web-based questionnaire about use of self-management strategies
15785936|NCT04565457|Device|Research CBCT|Each study participant will receive one additional CBCT scan, with 2D antiscatter grid in place. This is the only intervention in the study, referred as research CBCT scan, and it will be performed on one of the days during the participant's radiation treatment course. This additional research CBCT scan will be used strictly for the objectives of this study. It will not be used as part of the standard clinical care, such as imaging guidance of participant's radiation treatment or diagnostic purposes. To deliver participant's radiation treatment under CBCT guidance, a standard clinical CBCT scan will be acquired, as in standard clinical care protocols.
15785937|NCT04565444|Dietary Supplement|Ketone|"Ketone monoester supplement (R)-3-hydroxybutyl (R)-3-hydroxybutyrate based on participants' body weight (0.36g/kg body weight)
~Isocaloric carbohydrate control: dextrose + vanilla flavouring"
15785938|NCT04565444|Dietary Supplement|Ketone + Protein|"Ketone monoester supplement (R)-3-hydroxybutyl (R)-3-hydroxybutyrate based on participants' body weight (0.36g/kg body weight)
~10g Whey Protein
~L-[ring-2H5]-phenylalanine tracer (enriched to 4%)"
15785939|NCT04565444|Dietary Supplement|Protein|"Isocaloric carbohydrate control: dextrose + stevia
~10g Whey Protein
~L-[ring-2H5]-phenylalanine tracer (enriched to 4%)"
15785940|NCT04565431|Drug|Tysabri|Participants with RRMS who are planning to begin treatment with Tysabri will be compared to a group of healthy individuals who are matched for age, gender, and education.
15785941|NCT04565418|Behavioral|High-intensity interval training|3 times per week high-intensity interval training (HIIT) will be performed on a cycle ergometer for 12 weeks adding up to 36 HIIT sessions
15785942|NCT04565405|Other|Detergent|The tracheostomy inner cannulas will be washed with detergent.
15785943|NCT04565405|Other|Sterile water|The tracheostomy inner cannulas will be washed with sterile water.
15785944|NCT04565392|Drug|Famotidine 20 milligram tablet|1 tablet every 12 hours and increase to 1 tablet every 8 hours if not improved by the second day of treatment
15785945|NCT04565379|Drug|NuSepin® 0.1 mg|NuSepin® 0.1 mg
15785946|NCT04565379|Drug|NuSepin® 0.2 mg|NuSepin® 0.2 mg
15785947|NCT04565379|Drug|Placebo|Normal Saline
15785949|NCT04565340|Other|Mode of delivery, maternal and neonatal outcomes/complications|Mode of delivery, maternal and neonatal outcomes/complications
15785950|NCT04565327|Drug|Hyperpolarized Carbon C 13 Pyruvate|Given IV prior to imaging
15785951|NCT04565327|Procedure|Magnetic Resonance Imaging (MRI)|Undergo MRI
15785952|NCT04565314|Dietary Supplement|Plumpy'Mum|Mothers will consume Plumpy'Mum (one packet daily) from enrollment (child age 0-3 months) for 3 months.
15785953|NCT04565301|Drug|Dexamethasone|adductor canal block
15785954|NCT04565301|Drug|neostigmine|adductor canal block
15785955|NCT04565301|Other|NaCl solutions|adductor canal block
15785958|NCT04565275|Drug|Drug ICP-192|"Dose Escalation Phase ICP-192 will be taken by patients with advanced solid tumor and will be treated follow the 3+3 dose escalation scheme
~Dose Expansion Phase ICP-192 will be taken by patients with urothelial carcinoma or cholangiocarcinoma with FGFR gene alterations and will be treated at a single dose defined from the Dose Escalation Phase."
15785959|NCT04565262|Drug|NAs+IFN-α|NAs+IFN-α:(NAs +IFN)/96 weeks：NAs（when the CHB patients<2years old, the drug is LAM）combined with IFN-α（when the CHB patients<3years old, the drug is IFN-α）for 96 weeks。 NAs+(NAs+IFN-α) :NAs/48weeks+(NAs+ IFN)/96 weeks：NAs（when the CHB patients<2years old, the drug is LAM）for 48 weeks ，then combined with IFN-α（when the CHB patients<3years old, the drug is IFN-α）for 96weeks。 Response guided treatment（RGT） by HBsAg quantification： The course of interferon alpha was 24 weeks after HBsAg and HBeAg turned negative up to 96 weeks, and NAs was discontinued 12 months after HBsAg serological conversion.
15785962|NCT04565236|Biological|Recombinant Factor VIII (Kovaltry, BAY81-8973) Treatment Group 1|"25 to 50 IU of Kovaltry per kg body weight given via intravenous (IV) infusion twice weekly, three times weekly, or every other day according to individual requirements for 6 months.
~The dose decisions are at the discretion of the investigator."
15785963|NCT04565236|Biological|Recombinant Factor VIII (Kovaltry, BAY81-8973) Treatment Group 2|"12 year-old: 25 to 50 IU of Kovaltry per kg body weight given via intravenous (IV) infusion twice weekly, three times weekly, or every other day for 6 months.
~>12 year-old: 20 to 40 IU of Kovaltry per kg of body weight given via intravenous (IV) infusion two or three times per week for 6 months.
~The dose decisions are at the discretion of the investigator."
15785964|NCT04565236|Biological|Recombinant Factor VIII (Kovaltry, BAY81-8973) Treatment Group 3|"15 to 50 IU of Kovaltry per kg body weight (minimum dose: 250 IU) given via intravenous (IV) infusions at least once a week.
~The dose decisions are at the discretion of the investigator."
15785965|NCT04565223|Behavioral|Cognitive behavioral therapy for insomnia|is a multicomponent intervention which focuses on cognitive and behavioral factors that contribute to sleep disorders , The CBT-i included sleep hygiene counseling, stimulus control, cognitive restructuring, relaxation techniques, and benzodiazepine therapy or withdrawal (when needed). To conduct the intervention, guidelines for GPs and nurses and graphic and written materials for patients (sleep diary, registry of behavior habits, and cognitive problems) were developed
15785966|NCT04565210|Other|Music exposure|Participants will be offered individual sessions of music. They will be exposed for 10 minutes per day, 3 days per week for a period of 2 weeks using a headphone.
15785967|NCT04565210|Other|Silence|Participants in this group will be offered individual silence session for 10 minutes per day, 3 days per week for a period of 2 weeks using a headphone.
15785968|NCT04565197|Biological|convalescent plasma|"Transfuse 2 aliquots of plasma (200 mL x 2) per patient.
~Transfuse first aliquot for 2-3 hours (~1.4 to 2 mL/min)
~Transfuse second aliquot at same rate 2 hours after completion of first aliquot"
15785969|NCT04565184|Drug|Artesunate-amodiaquine combination|Artesunate-amodiaquine (Coarsucam®: Sanofi-Aventis, France) is co-packaged as artesunate 50 mg and amodiaquine hydrochloride USP equivalent to amodiaquine base of 153.1 mg. Each child shall be given one, two or three tablets depending on the weight.
15785970|NCT04565184|Drug|Artemether, Lumefantrine Drug Combination|Artemether-lumefantrine (Coartem®: Novartis, Switzerland) is formulated as tablets and will be provided in blister packs. Each tablet contains 20 mg artemether and 120 mg lumefantrine. Every pack has a picture showing how the drug should be given and contains two blisters for each day with one, two or three tablets depending on the weight of the child
15785971|NCT04565171|Drug|Yimitasvir Phosphate Capsule|DAG181 100 mg (100 mg Capsule) administered orally
15785972|NCT04565145|Drug|Kava Dietary Supplement|Participants will be given three 75mg kava capsules per day for one week
15785973|NCT04565145|Drug|Placebo|Participants will be given three placebo capsules per day for one week
15785974|NCT04565132|Device|High Definition transcranial Direct Current Stimulation|1x1 tDCS low-intensity stimulator and 4x1 multichannel stimulation adaptor (Soterix Medical Inc, New York, NY)
15785975|NCT04565119|Other|No intervention. This is an observational study.|There are no interventions being tested in the Bio-BOOST study.
15785976|NCT04565106|Device|Closed-loop control of oxygen supplementation by O2matic|Closed-loop control of oxygen supplementation to achieve a target SpO2 of 92 - 96 %
15785977|NCT04565093|Procedure|iPACK|"Interspace between the popliteal artery and the capsule of the posterior knee (iPACK):
~This is basically ultrasound guided peripheral nerve block performed by the anesthesiologists at the posterior side of the knee to control pain after TKA."
15785978|NCT04565093|Procedure|Periarticular local infiltration analgesia (LIA)|A mixture of Bupivacaine 0.25% 20 ml + epinephrine 100 mics ± lornoxicam 8 mg ± morphine 10 mg ± tranexamic acid 1 gm in 40 ml normal saline (NS) will be injected into the posterior capsule and the medial and lateral ligaments just before implantation: after insertion of the implants and into the capsule and retinacular tissues. The remaining solution (approximately 20 mL) will be used to infiltrate the muscle and subcutaneous tissues. This intervention is commonly performed by the operating orthopedic surgeon to control pain after TKA.
15785979|NCT04565054|Drug|Abemaciclib 50 MG; 150mg 1-0-1 per os|Experimental: Abemaciclib plus ET Abemaciclib 150 mg, 2 x daily, resulting in 300 mg/day, oral, 24 months plus endocrine treatment of physician´s choice
15785980|NCT04565041|Behavioral|Social Support|Presence of an image of a social support figure (provided by participant) during a fear extinction procedure
15785981|NCT04565028|Behavioral|Contingency Management (CM)|Contingency management is an intensive behavioral therapy in which participants are paid to reduce substance use.
15785982|NCT04565015|Biological|GC5107|Intravenously infused at a dose of 300 - 900 mg per kg (of body weight) every 21 or 28 days for 12 months
15785983|NCT04565002|Device|Transcutaneous Electrical Diaphragmatic Stimulation|The procedure consists of electrical stimulation in the region of the motor points of the diaphragm. Its configurations contribute to produce involuntary muscle contractions. There are four electrodes positioned superficially on the skin.
15785984|NCT04564976|Behavioral|Social support image|An image of a social support figure specific to each participant (provided by the participant) will be present while participants undergo a fear acquisition procedure. Specifically--the image will be presented alongside a neutral image that is either consistently paired with shock (CS+) or never paired with shock (CS-), so that assessment of whether there are differences in fear responding (evaluated via SCR) due the shock pairing can be assessed. This is a typical fear acquisition procedure, and a typical outcome would be for SCR to be higher for the CS+ compared to the CS- toward the end and following the procedure, indicating that the CS+ is now associated with the aversive shock and is bringing about a fear response (in this case indexed by increased sympathetic nervous system activity preparing the body to fight or flee).
15785986|NCT04564950|Other|Observation of serum and salivary Galectin-3 levels|Observation of serum and salivary Galectin-3 levels and correlation with periodontal indices
15785987|NCT04564937|Drug|SCT510A|SCT510A of 0.625mg、1.25mg、2.0mg、2.5mg,IVT
15785988|NCT04564924|Radiation|DXA|Bone mineral density was examined in all cases and controls
15785989|NCT04564911|Combination Product|Flash Glucose Monitoring and Education|Participants will wear the flash glucose monitoring system, and receive an education package on how to self-manage their glucose levels. They will use the flash glucose monitoring system continuously for 6 weeks. From week 6 to week 24, the frequency of use of flash glucose monitoring will be reduced to one sensor every 4 weeks. They will receive education at weeks 0, 2, 8 and 16. They will also wear a blinded sensor for the last 2 weeks of the intervention period (week 25 to week 26). After the first 24 weeks, participants enter the observation phase (weeks 38 to 52) wherein they will be encouraged to continue monitoring their glucose levels through capillary glucose monitoring, during pre-meals and bedtime daily.
15785990|NCT04564911|Combination Product|Capillary glucose monitoring and Education|Participants will use a capillary glucose meter and receive an education package on how to self-manage their glucose levels. Participants will be encouraged to test their blood glucose levels at least twice a day, but preferably 4 times daily: pre-meal and bedtime blood glucose levels. They will receive education at weeks 0, 2, 8 and 16. They will wear a blinded sensor again after the last 2 weeks of the intervention period (week 24 to week 26). After the first 24 weeks, participants enter the observation phase (weeks 38 to 52) wherein they will be encouraged to continue monitoring their glucose levels through capillary glucose monitoring, during pre-meals and bedtime daily.
15785991|NCT04564898|Drug|Capecitabine|"Part 1 • Capecitabine, 1000 mg/sqm orally twice daily on days 1-14 each 28 days
~Part 2
~• Capecitabine, 1000 mg/sqm orally twice daily on days 1-14 each 28 days"
15785992|NCT04564898|Drug|Bevacizumab|"Part 1 • Bevacizumab, 5 mg/kg IV dose over 30 minutes on days 1 and 15 each 28 days
~Part 2
~• Bevacizumab, 5 mg/kg IV dose over 30 minutes on days 1 and 15 each 28 days"
15785993|NCT04564898|Drug|Trifluridine/Tipiracil|"Part 1 • Trifluridine/tipiracil, dose escalation from 25 mg/sqm to 35 mg/sqm orally twice daily on days 15-19 (and days 22-26) each 28 days
~Part 2
~• Trifluridine/tipiracil, at the recommanded dose established during part 1 orally twice daily on days 15-19 (and days 22-26) each 28 days"
15785994|NCT04564885|Device|BAGUERA®C Cervical Disc Prosthesis|surgery
15785995|NCT04564885|Device|Mobi-C Cervical Disc|surgery
15785996|NCT04564872|Drug|HSK7653 10 mg Q2W|HSK7653 5 mg (2 tablets) and placebo 25 mg (1 tablet) Q2W, placebo of linagliptin 5 mg QD, oral, week 1 to week 24; HSK7653 25 mg Q2W, oral, week 25 to week 52.
15785997|NCT04564872|Drug|HSK7653 25 mg Q2W|HSK7653 25 mg (1 tablet) and placebo 5 mg (2 tablets) Q2W, placebo of linagliptin 5 mg QD, oral, week 1 to week 24; HSK7653 25 mg (1 tablet) Q2W, oral, week 25 to week 52.
15785998|NCT04564872|Drug|Linagliptin 5 mg QD|Linagliptin 5 mg QD, placebo of HSK7653 25 mg (1 tablet) and 5 mg (2 tablets) Q2W, oral, week 1 to week 24; HSK7653 25 mg Q2W, oral, week 25 to week 52.
15785999|NCT04564859|Device|Heated Humidified High-Flow Nasal Cannula|Participants using of invasive ventilator more than 14 days, maybe considered transferred to the Respiratory Care Center(RCC), participants enrolled to this study and also written informed consent from participants or their family; After extubation, the difficult weaning patients were allocated to two treatment groups, and randomly assigned to Heated Humidified High-Flow Nasal Cannula or Noninvasive Ventilation devices.
15786000|NCT04564846|Drug|ORMD-0801|8 mg capsules of ORMD-0801 (Oral Insulin)
15786001|NCT04564846|Other|Placebo|Placebo capsule (Fish Oil)
15786002|NCT04564833|Drug|Low Dose RBT-1|45 mg SnPP/240 mg FeS will be administered as a single IV infusion over a 120-minute period ≥24 hours but ≤48 hours prior to scheduled cardiac surgery
15786003|NCT04564833|Drug|High Dose RBT-1|Normal saline will be administered as a single IV infusion over a 120-minute period ≥24 hours but ≤48 hours prior to scheduled cardiac surgery
15786004|NCT04564833|Drug|Placebo|Normal saline will be administered as a single IV infusion over a 120-minute period ≥24 hours but ≤48 hours prior to scheduled cardiac surgery
15786005|NCT04564807|Behavioral|Web-Based Insomnia Education Program|"Participants will be given access to a web-based program on sleep education to read at their own pace during the 9-week intervention period. The program content overlaps with SHUTi on the following topics: insomnia symptoms, impacts, and causes, basic sleep improvement strategies, and when to see a doctor. The information is akin to that found on WebMD or National Sleep Foundation website. Unlike the SHUTi program, the information is fixed, accessible immediately (no week-to-week information unlocking) and there are no customized bedtime or wake-time suggestions based on sleep diary data."
15786044|NCT04564456|Drug|ADVAIR DISKUS® 500/50|2 inhalations Reference product in one study period
15786006|NCT04564807|Behavioral|SHUTi Intervention|"Sleep Healthy Using the Internet (SHUTi) is a well-validated version of e-CBT-I comprised of 6 weekly educational modules and daily sleep diaries. Participants will have 9 weeks to complete 6 once-weekly educational cores. Cores consist of: insomnia overview, sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention, and last approximately 45 minutes each. Participants will receive weekly objectives, as well as review and feedback on the previous core's assignments and sleep diary data, new material, assignments, and a summary. These features are supplemented with interactive features (i.e., personalized goal-setting, video vignettes). Participants receive daily emails prompting them to complete the 11-item sleep and alcohol use diary daily during the intervention."
15786007|NCT04564768|Behavioral|Online Mindfulness-Based Cancer Recovery (MBCR)|Mindfulness-Based Cancer Recovery (MBCR) is a standardized group program which focuses primarily on the challenges faced by people living with cancer. It is an 8-week program consisting of weekly group meetings of 1.5 to 2 hours. Home practice of 45 minutes per day (15 min yoga; 30 min meditation) is prescribed. As the weeks progress, different forms of meditation are introduced, beginning with a body scan sensory awareness experience, progressing to sitting and walking meditations. Gentle Hatha yoga is incorporated throughout, as a form of moving meditation. Didactic instruction as well as group discussion and reflection, problem solving and skillful inquiry are commonly applied teaching tools.
15786011|NCT04564729|Other|Shared Decision Making|The intervention group will receive a shared decision-making intervention including a decision aid and conversation with a study investigator. The intervention group will have the opportunity to choose the number of opioid pills they receive at discharge from hospital after total knee arthroplasty.
15786012|NCT04564716|Biological|Gam-COVID-Vac|vaccine for intramuscular injection
15786013|NCT04564716|Other|Placebo|placebo comparator
15786014|NCT04564703|Drug|Iberdomide|IBERDOMIDE (CC220) IN MAINTENANCE AFTER AUTOLOGOUS STEM CELL TRANSPLANTION IN NEWLY DIAGNOSED MULTIPLE MYELOMA PATIENTS
15786015|NCT04564690|Dietary Supplement|QUARTET® hen eggs (enriched in n-3 PUFA, selenium, vitamin E and lutein)|Consumption of three QUARTET® hen eggs (enriched in n-3 PUFA, selenium, vitamin E and lutein) per day for three weeks
15786016|NCT04564690|Dietary Supplement|Regular hen eggs|Consumption of three regular hen eggs per day for three weeks
15786017|NCT04564677|Device|Ifabond (Péters surgical)|Ifabond (Péters surgical) is a CE-marked synthetic surgical glue for internal and external use. The glue is non-toxic, biocompatible and biodegradable. It is commercially available and can be used for mesh fixation, as tissue adhesive, for sealing of sutured tissue and for hemostasis.
15786018|NCT04564664|Drug|Oxygen|High-flow nasal cannula oxygen therapy vs. standard oxygen therapy
15786019|NCT04564651|Other|platelet transfusion|when the ADP inhibition >70%, give one unit platelet tansfusion
15786020|NCT04564638|Drug|Corticosteroid|
15786021|NCT04564625|Other|Vitamin D Assessment|index admission vitamin D assessment
15786022|NCT04564625|Other|Fracture|rate of nonunion (i.e., failure of a fractured bone to heal)
15786023|NCT04564612|Drug|BIIB091|Administered as specified in the treatment arm
15786024|NCT04564612|Drug|Rabeprazole|Administered as specified in the treatment arm
15786025|NCT04564612|Drug|Itraconazole|Administered as specified in the treatment arm
15786026|NCT04564586|Behavioral|DPPFit|Participants issued Fitbit Device and set up Fitbit App. They are then enrolled in the automated text messaging platform. Day 1 of the intervention begins the Monday after consent. All consented participants receive the full intervention.
15786027|NCT04564560|Procedure|Endovascular aortic repair with Zenith Alpha Spiral-Z®|The Zenith Alpha Spiral-Z® stent graft may have an increased risk of thrombosis. The intervention in this study is to assess the extent and degree of thrombosis in patients treated with the Zenith Alpha Spiral-Z® during endovascular repair of aortic aneurysm
15786028|NCT04564547|Drug|Islatravir|ISL capsule taken by mouth.
15786029|NCT04564547|Drug|MK-8507|MK-8507 tablet taken by mouth.
15786030|NCT04564547|Drug|BIC/FTC/TAF|BIC/FTC/TAF tablet taken by mouth.
15786031|NCT04564547|Drug|Placebo to ISL|Placebo capsule matched to ISL taken by mouth.
15786032|NCT04564547|Drug|Placebo to MK-8507|Placebo tablet matched to MK-8507 taken by mouth.
15786033|NCT04564547|Drug|Placebo to BIC/FTC/TAF|Placebo tablet matched to BIC/FTC/TAF taken by mouth.
15786034|NCT04564534|Other|MoCA cognitive assessment|cognitive assessment using the validated MoCA test administered via an application on an iPad
15786035|NCT04564521|Drug|Nitroglycerin|Intravenous nitroglycerin (0.5mcg/kg/min) is infused after the induction of general anesthesia and during intra-arterial chemotherapy to reduce the cardio-respiratory side effects.
15786036|NCT04564521|Drug|Normal saline|Intravenous normal saline is infused after the induction of general anesthesia and during intra-arterial chemotherapy as an active comparator.
15786037|NCT04564495|Behavioral|Seated exercise|Exercise will include repetitive bouts of high intensity exercises with intermittent periods of rest or active recovery. circuit of moves like 'jabs', 'hooks' etc, and a strength and endurance class that promotes postural awareness.
15786038|NCT04564482|Radiation|CRT|50 Gy in 2 Gy fractions over 25 working days + capecitabine 1650 mg/m2/d PO
15786039|NCT04564482|Radiation|SCPRT|25 Gy in 5 Gy fractions over 5 working days
15786040|NCT04564482|Radiation|CROSS Protocol|41.4 Gy in 1.8 Gy fractions over 23 working days + carboplatin AUC of 2 mg/ml/min + paclitaxel 50 mg/m2 IV Q1W
15786041|NCT04564482|Diagnostic Test|PD-L1 PET|10 mg atezolizumab IV followed by 37 MBq 89Zr-atezolizumab IV. PET imaging will be done before neoadjuvant CRT/SCPRT (day 0) and between day 10-14 during CRT/SCPRT.
15786042|NCT04564469|Drug|Furosemide|A number of different protocols exist in terms of the timing of furosemide injection, (F+0) protocol in which furosemide is injected at the same time of radiotracer administration &( F - 15)protocol in which furosemide is administered 15 min before tracer administration
15786043|NCT04564456|Drug|Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg/Respirent|2 inhalations of Test oproduct in one study period
15786045|NCT04564443|Other|Medaxis Debritom+|Advanced micro water jet debridement to clean and debride wound
15786046|NCT04564443|Other|Sharp Surgical Debridement|Scalpel or Curette to clean and debride wound
15786047|NCT04564443|Other|Additional Outer Dressing Application|Application of moisture retentive dressing, and a multi layer compression dressing
15786048|NCT04564443|Other|Offloading|Patient will be offloaded in a diabetic camboot after treatment, or total contact cast if patient cannot be fit with diabetic offloading boot
15786049|NCT04564443|Other|Fibracol Wound Dressing|Aaplication of a collagen alginate dressing
15786050|NCT04564430|Drug|Catapresan|The intervention is either a single intravenous bolus of 3mcg/kg Catapresan (150mcg/1ml) or an equal amount of saline at the time of tourniquet inflation.
15786051|NCT04564430|Other|Saline|controlgroup receiving saline
15786052|NCT04564417|Biological|W0180|Participants will receive W0180 in a 21-day cycle.
15786053|NCT04564417|Drug|Pembrolizumab|Participants will receive Pembrolizumab 200 mg flat dose as IV infusion every three weeks (Q3W) in a 21-day cycle.
15786054|NCT04564404|Other|Survey|Questionnaire to ask about the willingness-to-buy applications in neuromuscular monitoring.
15786055|NCT04564391|Dietary Supplement|protein supplement|protein supplement, twice daily, 2 x 30 g of protein, 3 weeks of intervention; blinded to patients and personnel
15786056|NCT04564391|Dietary Supplement|placebo supplement|Placebo supplement, twice daily, 2 x 30 g of placebo, 3 weeks of intervention; blinded to patients and personnel
15786057|NCT04564365|Drug|beta-blocker|To investigate the relationship between the use of beta blockers and prognosis in patients with normal ejection fraction after acute myocardial infarction
15786058|NCT04564352|Dietary Supplement|Adansonia digitata|Juice of AD fruit
15786059|NCT04564339|Drug|Ravulizumab|Dosages (loading and maintenance) will be based on the participant's body weight.
15786060|NCT04564339|Drug|Placebo|Dosages (loading and maintenance) will be based on the participant's body weight.
15786061|NCT04564339|Other|Background Therapy|Participants will receive background therapy consistent with the standard of care.
15786062|NCT04564326|Procedure|Pericapsular nerve Group block|Under ultrasound guidance a needle is inserted between the iliopectineal eminence and the iliopsoas muscle and tendon to block articular branches supplying the capsule of hip joint.
15786063|NCT04564326|Procedure|Facia Iliaca block|Under ultrasound guidance a needle is inserted between the fascia iliaca and Psoas muscle to block the femoral, obturator and lateral cutaneous nerves.
15786064|NCT04564326|Drug|Fentanyl|Intravenous fentanyl in a dose of 1mic/kg divided into two boluses with 5 minutes interval in between.
15786065|NCT04564313|Drug|Camrelizumab treatment|Camrelizumab (SHR-1210), 200mg, I.V., Q3W
15786066|NCT04564300|Procedure|Training|Both groups will perform a standardized training protocol
15786069|NCT04564248|Other|Website access|website access will be provide to families
15786070|NCT04564235|Genetic|genome-wide analyses|genome-wide analyses will be done in patients and parents (father, mother)
15786071|NCT04564235|Genetic|Search for de novo mutations in paternal sperm samples|Sperm analysis will be done in paternal samples
15786072|NCT04564222|Dietary Supplement|Micronutrient Enriched Crackers (MECs)|"MECs are manufactured according to the Standard Operational Procedures which have been developed taking into account the Hazard Analysis and Critical Control Point (HACCP) to maintain quality and safety and ensure the Ready-to-eat MEC products are safe. Data on the micronutrient concentrations and any potential bacteriological (Salmonella sp is negative, Bacillus cereus, Enterobacteriaceae, and Coagulase positive streptococci level are considered safe) and chemical contaminants (Pb, Hg, Cd, As, and Sn are not detectable) in the MEC products have been obtained from analysis in the laboratory of Saraswanti Indo Genetech, which has been accredited by KAN LP-184-IDN with SNI ISO/IEC 17025: 2008. Laboratory analysis of MEC products will be repeated at the middle and the end of the RCT to check on the quality and safety of the MEC product."
15786073|NCT04564222|Dietary Supplement|Placebo|"Placebo crackers are manufactured according to SOPs which have been developed taking into account the HACCP to maintain quality and safety and ensure the Ready-to-eat placebo products are safe. Data on the micronutrient concentrations and any potential bacteriological (Salmonella sp is negative, Bacillus cereus, Enterobacteriaceae, and Coagulase positive streptococci level are considered safe) and chemical contaminants (Pb, Hg, Cd, As, and Sn are not detected) in the placebo have been obtained based on the analysis in the laboratory of Saraswanti Indo Genetech, which has been accredited by KAN LP-184-IDN with SNI ISO/IEC 17025: 2008. Laboratory analysis of placebo samples will be repeated at the middle and the end of the RCT to check on the quality and safety of the placebo product."
15786074|NCT04564209|Other|Info Viz for Health|During the intervention, health care providers provide HIV-related health education using a mobile app that contains a bilingual database of relevant infographics.
15786075|NCT04564196|Procedure|Breath Sample|breathe 2 tidal volume breaths into a single breath collection bag. The breath collection bag will be closed between each breath. The combined 2 tidal volume breaths will count as a single sample.
15786076|NCT04564183|Other|Sample collection|Blood, Urine, Nail, Hair, Saliva, optional Stool
15786077|NCT04564183|Other|Questionnaires|SF-36, Food Frequency, Pulmonary Fibrosis Study questionnaire, COVID questionnaire
15786078|NCT04564183|Radiation|High resolution CT scan of the chest|Upon enrollment, all patients will undergo single prone volumetric thoracic chest CT scan. This will be performed at full inspiration using a 64-slice CT scanner.
15786079|NCT04564183|Diagnostic Test|Pulmonary Function Test|All recruited subjects will undergo a pre-bronchodilator spirometry test and a lung diffusion capacity test, both in accordance with ATS guidelines. Exercise capacity (maximum physical exertion) will be assessed by performing a 6-minute walk test, also according to ATS guidelines.
15786080|NCT04564157|Drug|Carboplatin|"Structure: The cis-diamino (cyclobutan-1, 1 dicarboxilate) plating. Stability: 24 hours at ambient temperature in 5% glucose, glucosaline or physiologic saline. It is recommended not to dilute with chlorinated solutions for this could affect the carboplatin.
~Route of administration: Intravenous infusion.
~Guidelines of Carboplatin administration: According to the standard of each center."
15786081|NCT04564157|Drug|Paclitaxel|"Structure: A diterpene whose composition is: 5b, 20-epoxi-1, 2a, 4,7b, 10b, 13a-hexa-hidroxytax-11-en 9 one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)- N-benzoyl-3-phenylisoserine.
~Stability: Concentrations of 0.3-1.2 mg/ml in 5% dextrose or normal saline have demonstrated chemical and physical stability for more that 27 hours at ambient temperature (25ºC approximately). The intact vial must be stored between 15º and 25ºC.
~Guidelines on Paclitaxel administration: Paclitaxel must be administered by infusion over 3 hours in dextrose (D5W) or normal saline (NS). The concentration must not exceed 1.2 mg/ml."
15786082|NCT04564157|Drug|Nivolumab|"Structure: Nivolumab is a soluble protein consisting of 4 polypeptide chains.
~Route of administration: Intravenous infusion.
~Product Description: Nivolumab (BMS-936558-01) Injection drug product is a sterile, non-pyrogenic, single-use, isotonic aqueous solution formulated in 10 mg/ml.
~Storage Conditions: It must be stored at 2 to 8 degrees Cº and protected from light and freezing.
~Guidelines: The administration of nivolumab infusion must be completed within 24 hours of preparation.The dose of Nivolumab for the adjuvant treatment is 360 mg administered as an intravenous infusion over 30 minutes every 3 weeks (+/-3 days) for 4 cycles.
~For the maintenance adjuvant treatment the dose is nivolumab 480 mg Q4W (+/-3 days) over 30 minutes for 6 months (6 cycles).
~Subjects should be carefully monitored during nivolumab administration to follow infusion reactions.
~Doses of nivolumab may be interrupted, delayed, or discontinued depending on how well the subject tolerates the treatment."
15786083|NCT04564144|Drug|Meclizine Hydrochloride|A study will be conducted on the three tested orodispersible tablets and the commercial one (control). 6 volunteers are asked to cease any medication 7 days prior to blood sampling at least. Each volunteer will undergo 4 study sessions with one week of washout period in between (cross-overed to receive the other formulation). All volunteers are asked to fast overnight before taking the tablet. The tablet should be kept for 10 min in the mouth before swallowing without water. Just before taking the tablet, three milliliters of venous blood samples will be drown (predose, 0 h) and at 30, 60, 90, 120, 240, 360, 480, 720 min and 24 h postdose and stored in tubes coated with sodium heparin. Separation of plasma from Blood samples will be carried out by centrifuging at 5000 rpm for 10 min, then, it will be frozen at -20°C until analysis. By employing high-performance liquid chromatography (HPLC), the plasma concentration of MCZ will be assayed
15786084|NCT04564131|Other|Reflexology|"Hands are washed.
~The individual is provided to be in a comfortable position to lie down or to be in a semi-sitting position.
~The toes of the patient are crossed and the patient's feet are placed at our chest level when we sit.
~Depending on the size of the foot, a slightly moisturizing amount of non-allergenic petroleum jelly is taken, and it is spread to provide slipperiness.
~Exercises to warm and relax the feet for five minutes.
~General massage is applied to the whole foot for five minutes.
~Reflexology massage is applied to the application areas for neuropathic pain.
~The individual is helped to take a comfortable position.
~Hands are washed."
15786085|NCT04564131|Other|Control|No intervention was performed to reduce pain in the control group
15786086|NCT04564118|Drug|Retrospective analysis of assigned treatment|analysis of treatment assigned by physicians within routine clinical practice
15786087|NCT04564105|Behavioral|simulation education|Intubation protocol will be trained by simulation exercise.
15786088|NCT04564092|Drug|DaTSCAN™ Ioflupane (123I) Injection|Each subject will receive a single administration of DaTSCAN™ ioflupane (123I) injection by bolus IV injection with a nominal iodine (123I) activity of 111 MBq ±10%, in a maximum volume of 5 mL.
15786089|NCT04564066|Biological|efgartigimod IV|intravenous infusions of efgartigimod
15786090|NCT04564066|Biological|efgartigimod PH20 SC|subcutaneous injections of efgartigimod PH20 SC
15786091|NCT04564053|Drug|LNA043|Single intra-articular injection on Day 1
15786092|NCT04564053|Drug|Placebo|Single intra-articular injection on Day 1
15786093|NCT04564040|Drug|Acalabrutinib Treatment A|Participants will receive 100 mg AT suspension in water via NG tube.
15786094|NCT04564040|Drug|Acalabrutinib Treatment B|Participants will receive 100 mg acalabrutinib capsule suspension via NG tube.
15786095|NCT04564040|Drug|Acalabrutinib Treatment C|Participants will receive 100 mg AT suspension in water via NG administration plus 20 mg rabeprazole.
15786096|NCT04564040|Drug|Acalabrutinib Treatment D|Participants will receive 100 mg AT orally.
15786097|NCT04564027|Drug|Ceralasertib|Tablets will be administered orally
15786098|NCT04564014|Behavioral|ISSS|The ISSS aims to help participants acquire problem-solving (e.g., interpersonal problems) and time management based on the treatment manual of the therapy. Video introductions for each session and example teacher characters who depict the targeted problems and demonstrate implementation of coping/management techniques in a variety of situations. ISSS will use metaphors, daily examples, and lively narrative stories to enhance motivation for participation and understanding of the intervention contents. Session 2-5 will assign exercise and homework. Within 48 hours, participants will receive personalized written feedback (e.g., suggestions) from an e-Coach on the exercises they have completed. Participants can contact e-Coaches via the online system if they have any questions regarding the contents. Questions that beyond the contents will be referred to the health psychologist (PI) by e-Coaches.
15786099|NCT04564014|Other|Education Materials|Participants will recieve education materials addressing the following issues: (1) introduction to mental health and mental illness; (2) signs and symptoms of depression; (3) treatment of depression and available community resources; (4) signs and symptoms of anxiety; (3) treatment of anxiety and available community resources. The education materials will be carefully developed by the health psychologists and clinical psychologist of the research team who are very experienced in education intervention for mental and emotional health.
15786100|NCT04564001|Drug|Infliximab|Patients will receive infliximab 5mg/kg intravenously at week 0; 2; 6; 14; 22 in arm A
15786101|NCT04564001|Drug|Tocilizumab|Patients will receive tocilizumab 8mg/kg intravenously at week 0; 4; 8; 12; 16; 20; 24 in arm B
15786102|NCT04563975|Drug|Toripalimab|Toripalimab，240mg，d1，Intravenous Infusion，q3w
15786103|NCT04563975|Drug|Docetaxel|Docetaxel，60-75mg/m2，d8 and d15，Intravenous Infusion，q3w
15786104|NCT04563975|Drug|nab-paclitaxel|nab-paclitaxel，125mg/m2，d1 and d 8，Intravenous Infusion，q3w
15786105|NCT04563962|Behavioral|Contingency Management-ART|Participants in this arm will participate in a Contingency Management intervention where rewards are linked with demonstrated adherence to tenofovir-based ART or PrEP.
15786106|NCT04563962|Behavioral|Contingency Management-Methamphetamine|Participants in this arm will participate in a Contingency Management intervention where rewards are linked with demonstrated abstinence from methamphetamine use.
15786107|NCT04563949|Other|Repeat Testing|Repeat Testing with the PLA will be conducted
15786108|NCT04563936|Drug|LY01005 3.6 mg|LY01005 was administered as 3 intramuscular (IM) injections, 28 days apart. As concomitant medications, Casodex® (50 mg/day) was orally administered during the whole study period.
15786109|NCT04563936|Drug|ZOLADEX® 3.6 mg|ZOLADEX® was administered as 3 Subcutaneous (SC) injections, 28 days apart. As concomitant medications, Casodex® (50 mg/day) was orally administered during the whole study period.
15786110|NCT04563923|Drug|Avdoralimab (IPH5401)|Preparation of avdoralimab and preparation of the syringes are to be performed aseptically by site pharmacy qualified personnel.
15786111|NCT04563923|Other|Control|"Superpotent topical steroids are the gold standard treatment for BP. All patients will receive 0.05% Clobetasol propionate cream as follows:
~Patients of less than 45kg of body weight: 2 tubes of 10g/d
~Patients of 45kg and above of body weight: 3 tubes of 10g/d Topical steroids will be applied every day until 15 days after the healing of the last bullous lesion"
15786112|NCT04563910|Other|young mania rating scale|questionnaires to the patients and their family after their written consent
15786113|NCT04563884|Other|Questionnaires|"Children 12 months to 5 years old will receive PEACH alone, children 5 years old to 11 years old will receive PEACH and SSQ-P, and children and adolescents over 11 years old will receive SSQ-P and SSQ-C (even between 11 and 13 years old, the PEACH also).
~Questionnaires will be completed twice, 15 days apart."
15786114|NCT04563871|Drug|80mg Osimertinib|One tablet of 80mg Osimertinib for oral administration per day
15786115|NCT04563858|Diagnostic Test|Validation|Assessment of Polish version of the 4AT
15786116|NCT04563845|Drug|GSK3640254|GSK3640254 will be available as 100 mg oral tablet for therapeutic dose. The Supratherapeutic dose will be determined based on the results of preliminary data from sentinel cohort(s).
15786117|NCT04563845|Drug|Placebo|Placebo will be available as GSK3640254 matching oral tablets.
15786118|NCT04563845|Drug|Moxifloxacin|Moxifloxacin will be available as 400 mg oral capsule.
15786119|NCT04563832|Other|Standardized respiratory management program|Bronchial decluttering education, respiratory physiotherapy, specialized medical follow-up for 2 years
15786120|NCT04563832|Other|CoughAssist|self-administered mechanical in-exsufflation - CoughAssist (2 x 15 min per day, 5 days per week for 2 years)
15786121|NCT04563819|Genetic|Genom-wide association study (GWAS) and biological pathway analyses|
15786122|NCT04563806|Procedure|Magnetic Resonance Imaging|Undergo MRI-guided surgery
15786123|NCT04563806|Procedure|Therapeutic Conventional Surgery|Undergo spinal surgery
15786124|NCT04563793|Device|Superion IDS|All patients to receive IDS for the treatment of moderate Lumbar Spinal Stenosis symptoms.
15786125|NCT04563780|Device|99mTC pertechnetate thyroid scan|Thyroid scintigraphy was performed just before RIT. 20 min after intravenous injection 99mTc-pertechnetate, anterior images of the neck were acquired using a scintillation camera equipped with low-energy high resolution collimator. Energy discrimination was provided with a 20% window that was centered on the 140 keV peak of 99mTc .
15786126|NCT04563767|Procedure|Infinitome|Added sequence of rs-fMRI.
15786127|NCT04563754|Diagnostic Test|mHRME (Mobile High resolution microendoscope)|"SOC (standard of care) HRA with Lugol's iodine will be performed. Unstained (abnormal) area will be evaluated with mHRME for optical biopsy diagnosis: 1) contrast agent will be applied to anal epithelium (5-10 ml of proflavine hemisulfate (0.01%)).2)The mHRME will then be inserted and imaging of abnormal tissues will be performed. This will add 2 to 6 minutes per procedure.
~This is a single-arm study where all subjects will receive both standard of care HRA (High resolution anoscopy) and experimental mHRME imaging."
15786128|NCT04563741|Behavioral|MOVE!+UP|behavioral weight management intervention developed for Veterans with PTSD
15786129|NCT04563741|Behavioral|MOVE!|standard VA weight management intervention
15786130|NCT04563728|Behavioral|Surveillance camera(s)|the mock camera intervention is for testing whether the impression of surveillance would have the effect to reduce the recidivism of elder abuse in home settings; 2) whether less costly options (mock cameras) are as effective as surveillance camera(s) in reducing the recidivism of elder abuse; 3) feasibility and acceptability of surveillance camera(s)
15786133|NCT04563702|Biological|VXA-CoV2-1|non replicating Ad5 adjuvanted oral tableted vaccine
15786134|NCT04563689|Other|CHX0.12+CPC0.05 oral rinse (PerioAidActive Control)|rinse 15 ml during 1 min during 5 days, twice daily
15786135|NCT04563689|Other|placebo rinse|destilled water rinse 15 ml during 1 min during 5 days, twice daily
15786136|NCT04563676|Biological|blood test|covid19 infected patient will have a blood test in order to make an autoimmune assessment (antinuclear antibodies, soluble nuclear anti-antigen, ANCA, antiphospholipid antibodies, FT3, FT4 , TSH, antithyroid antibodies, ACTH cortisol, and creation of a serotheque).
15786137|NCT04563663|Procedure|Posteriorization of the talus.|Three sets of a 30-s grade IV anteroposterior mobilization.
15786138|NCT04563650|Biological|blood sample|Sample collection of 4 to 10 tubes of whole blood will be done according to centre Saint-Victor's protocol.
15786139|NCT04563637|Diagnostic Test|Computer based vision application by video|patients will be tested by computer based analysis of a video as well as by dexa scan.
15786140|NCT04563637|Radiation|whole body dual energy x-ray absorptiometry scan|subjects will receive a whole body dual energy x-ray absorptiometry scan to measure their body fat percentage
15786141|NCT04563624|Drug|composite blocks|cad cam composite blocks
15786143|NCT04563611|Other|Turkish Get-up exercise|TG exercise, in 7 different steps (1. Starting position, 2. Supine girya lifting, 3. Elbow supported kettlebell lifting, 4. Hand supported kettlebell lifting, 5. High bridge, 6. Half above knee and lunge position, 7. Standing up) and the return of these different steps.
15786144|NCT04563611|Other|Askling L-Protocol|he protocol consists of 3 different exercises. These are exercise 1 aimed at increasing flexibility, exercise 2 providing strength and trunk / pelvis stabilization, and exercise 3 aiming at specific strengthening. Pain is not allowed to be provoked when performing the exercises.
15786145|NCT04563611|Other|Nordic hamstring exercise|To perform this exercise, participants will be asked to stand in an upright position on their knees. Hands and arms will be positioned on the chest and the individuals will be held by the physiotherapist at their heels. The individual will then be asked to lower the upper body forward as slowly as possible. Verbal commands will be given throughout the movement so that the hip and trunk smoothness is not disturbed.
15786146|NCT04563611|Other|Control Group|No exercise will be applied to the individuals in the control group. At the end of the 6-week period, all parameters will be evaluated again.
15786147|NCT04563598|Behavioral|Intensive lifestyle intervention (ILI)|Lifestyle intervention focused on weight loss through diet and physical activity
15786148|NCT04563598|Behavioral|Diabetes support and education (DSE)|Behavioral intervention focused on diabetes support and education
15786149|NCT04563572|Device|PPG Smartwatch|Participants will then receive a PPG sensor in form of a smartwatch) model and will be instructed to wear them continuously for 48 hours. Simultaneously, a 48-hour Holter ECG will be performed. Start time on the PPG-sensor and the Holter ECG will be matched and continuous heart rhythm and -rate monitoring will be initiated. Patients will wear the devices over a 48-hour period of time.
15786150|NCT04563559|Drug|Dextenza 0.4Mg Ophthalmic Insert|The eye will have a sustained release device of Dexamethasone 0.4 mg placed in the inferior nasal lacrimal system.
15786151|NCT04563559|Drug|Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]|The eye will be randomized to receive topical treatment with prednisolone acetate 1% on a tapering dose schedule
15786152|NCT04563546|Other|Quality Improvement|A quality improvement intervention including reminders, care protocols, and text messages to improve care of myocardial infarction in the KCMC ED
15786153|NCT04563533|Biological|Low-dose vaccine|"Active ingredients: recombinant ReNoV GI.1-VP1 protein, recombinant ReNoV GII.3-VP1 protein, recombinant ReNoV GII.4-VP1 protein and recombinant ReNoV GII.17-VP1 protein each 12.5μg.
~Other ingredients: aluminum hydroxide adjuvant 0.25 mg, L-histidine: 1.55 mg, sodium chloride: 4 mg, Tween 80: 1 μg, sodium dihydrogen phosphate: 47 μg, disodium hydrogen phosphate: 87 μg."
15786154|NCT04563533|Biological|High-dose vaccine|"Active ingredients: recombinant ReNoV GI.1-VP1 protein, recombinant ReNoV GII.3-VP1 protein, recombinant ReNoV GII.4-VP1 protein and recombinant ReNoV GII.17-VP1 protein each 25μg.
~Other ingredients: aluminum hydroxide adjuvant 0.25 mg, L-histidine: 1.55 mg, sodium chloride: 4 mg, Tween 80: 2 μg, sodium dihydrogen phosphate: 94 μg, disodium hydrogen phosphate: 173 μg."
15786155|NCT04563533|Biological|Placebo (containing aluminum)|Active ingredients: none Other ingredients: aluminum hydroxide adjuvant: 0.25 mg, L-histidine: 1.55 mg, sodium chloride: 4 mg, Tween 80: 2 μg, sodium dihydrogen phosphate: 94 μg, disodium hydrogen phosphate: 173 μg.
15786156|NCT04563533|Biological|Placebo (without aluminum)|Active ingredients: none Other ingredients: L-histidine: 1.55 mg, sodium chloride: 4 mg, Tween 80: 2 μg, sodium dihydrogen phosphate: 94 μg, disodium hydrogen phosphate: 173 μg.
15786157|NCT04563520|Drug|aPCC-emicizumab|Personalized dose of aPCC-emicizumab will be administered to participants. The max dose allowed for aPCC will be 25 U/kg/dose every 8 hours, for no more than 72 hours without further discussion with the PI.
15786158|NCT04563520|Drug|FEIBA|"FEIBA is an Anti-Inhibitor Coagulant Complex indicated for use in hemophilia patients with inhibitors for: control and prevention of bleeding episodes, perioperative management, routine prophylaxis to prevent or reduce the frequency of bleeding episodes. If there is less than a good' response in bleed event at 48 hours or less than moderate for surgical event control, the local PI can consider the use of thrombin generation guided rFVIIa with a max dose of no more than 90 µg/kg/dose every 8 hours for 72 hours, with wean to occur for no more than 7 total days."
15786159|NCT04563520|Drug|SEVENFACT|SEVENFACT [coagulation factor VIIa (recombinant)-jncw] is a coagulation factor VIIa concentrate indicated for the treatment and control of bleeding episodes occurring in adults and adolescents with hemophilia with inhibitors.
15786160|NCT04563507|Radiation|Stereotactic Body Radiation Therapy (SBRT) (50GY in 5 fractions)|Patients randomized to arm 2 will start letrozole alone, and add palbociclib on day 21, after completion of I-SBRT. They will undergo tumor Immunogenic-SBRT(I-SBRT) days 1-12 (+/-2 days, to enable inclusion of holidays). During the week preceding day 1, they will undergo simulation and planning for radiotherapy. Each oligometastatic lesion will be treated with I-SBRT every 48 hours. Treatment may be given daily (to keep the total I-SBRT treatment time to ≤ 12 days) and lesions targeted with I-SBRT will thus be alternated each day to accommodate for the 48 hour interval between fractions
15786161|NCT04563507|Drug|Letrozole 2.5Mg Tab|All patients start standard therapy with oral letrozole (Femara), day 1 of the study.
15786162|NCT04563507|Drug|Palbociclib 125mg|Patients randomized to arm 2 will start letrozole alone, and add palbociclib on day 21, after completion of I-SBRT.
15786163|NCT04563494|Drug|dexamethasone|Prevention of post op nausea and vomiting
15786215|NCT04563013|Device|Transcutaneous vagus nerve stimulation|the transcutaneous vagus nerve stimulation was conducted by ear clip with cathode and anode placed at the tragus for 30 min.
15786216|NCT04563000|Drug|Vitamin C|Ascorbic acid 1,5 g intravenously every 12-hours for 4 consecutive days
15786166|NCT04563468|Procedure|Strength inspiratory muscle training|Two training sessions per day consisting of 30 breaths (against external load of ~50% Pi,max; 4-5 minutes per session), 7 days/week (once/month supervised at the research center), for 6 months will be performed using an electronic tapered flow resistive loading (TFRL) device (POWERbreathe®KH1, HaB International Ltd., Southam, UK) according to an established method. Measurements of Pi,max will be performed every week and training loads will be increased continuously to maintain external load at ~50% of Pi,max values. Ratings of perceived inspiratory effort on a modified Borg scale (4-5 out of 10) will also be used to support decisions on increasing training load.
15786167|NCT04563468|Procedure|Endurance inspiratory muscle training|Two daily sessions of 30 breaths using TFRL device (POWERbreathe®KH1, HaB International Ltd., Southam, UK) and will train at an inspiratory load of no more than 10% of their initial Pi,max. This training load will not be changed during the entire study period. Participants in the control group will be offered the active treatment upon completion of the study.
15786168|NCT04563442|Other|complication|complication co morbidities
15786169|NCT04563429|Dietary Supplement|Oral Vitamin A|Oral administration of 5000 EU of Vitamin A during first 28 days of life
15786170|NCT04563403|Behavioral|Projection-based augmented reality therapy (P-ARET)|"The intervention will be based on exposure therapy to cockroaches using P-ARET. The treatment will follow the guidelines of the one-session treatment (OST). Main components: Psychoeducation, Exposure to the feared object (cockroach), modeling (the therapist will interact with the phobic stimulus first and if possible, the patient will follow the same steps), cognitive challenge, and reinforcement and relapse prevention."
15786171|NCT04563390|Behavioral|Projection-based augmented reality exposure therapy (P-ARET).|"The intervention will be based on exposure therapy to cockroaches using P-ARET. The treatment will follow the guidelines of the one-session treatment (OST). Main components: Psychoeducation, Exposure to the feared object (cockroach), modeling (the therapist will interact with the phobic stimulus first and if possible, the patient will follow the same steps), cognitive challenge, and reinforcement and relapse prevention."
15786172|NCT04563390|Behavioral|In vivo exposure therapy|"The intervention will be based on traditional in vivo exposure therapy to real cockroaches. The treatment will follow the guidelines of the one-session treatment (OST). Main components: Psychoeducation, Exposure to the feared object (cockroach), modeling (the therapist will interact with the phobic stimulus first and if possible, the patient will follow the same steps), cognitive challenge, and reinforcement and relapse prevention."
15786173|NCT04563377|Biological|ChAdOx1.HTI and MVA.HTI|ChAdOx1. HTI dose 5 x 10^10 vp MVA.HTI dose 2 x 10^8 pfu
15786174|NCT04563364|Other|Interdisciplinary hospital-home intervention|The intervention will start in NICU and to be continued at home with the support of ICT. The NICU intervention will have theoretical and practical components, the theoretical one will be about motor development in premature infants, and practical one will have strategies for motor early intervention, it will be demonstrated with pediatric simulator and parents should be demonstrate it with a infant: 1Sensorial motor stimulation, visual and auditory follow-6up; Tactile integration 3Extension muscle activation 4Middle line integration 5Alignment reaction stimulation in prone position 6Flexor muscle activation with transition to lateral position 7Flexor muscle activation with transition to sitting position 8Facilitation of reciprocal flexion and extension lower limbs. All parents will receive a motor sensorial kit that will include roller, visual tags, blankets and rattles, it will be for apply the strategies for motor early intervention, and will be supported by ICT
15786175|NCT04563364|Other|Convencional treatment|Control group will receive a conventional treatment given by the institutions
15786176|NCT04563351|Other|local anaesthetic techniques|The patients were anesthetized with two different local anaesthetic techniques.
15786177|NCT04563338|Drug|Atezolizumab|Atezolizumab is a type of drug called a monoclonal antibody. Antibodies are proteins that are naturally found in the blood stream that fight infections. Monoclonal antibodies are a special kind of antibody that is created in a laboratory. These drugs bind (attaches) to specific proteins in the body that may be involved in cancers. Atezolizumab binds to PD-L1 which is a protein involved preventing the body's immune system (defense system against infection and disease) from fighting cancer cells. Blocking PD-L1 is expected to help the immune cells to destroy the cancer cells.
15786178|NCT04563338|Drug|Bevacizumab|Bevacizumab is a type of drug called a monoclonal antibody. Antibodies are proteins that are naturally found in the blood stream that fight infections. Monoclonal antibodies are a special kind of antibody that is created in a laboratory. These drugs bind (attaches) to specific proteins in the body that may be involved in cancers. Bevacizumab binds to vascular endothelial growth factor (VEGF) which is a protein involved with the growth of new blood vessels. Blocking VEGF will prevent blood vessels from forming and therefore stopping oxygen and nutrients to be supplied to cancer cells. Without oxygen and nutrients, the cancer cells will die.
15786179|NCT04563325|Drug|Oral co-amoxiclav or oral dicloxacillin only|High dose oral treatment followed by standard dose oral treatment
15786180|NCT04563325|Drug|IV ceftriaxon followed by oral co-amoxiclav or oral dicloxacillin|IV treatment followed by standard dose oral treatment
15786181|NCT04563312|Procedure|Exercise|Nine different clubs and sport centers were screened and 18- to 35-year-old individuals regularly engaged in MT or BB for the last 6 months were invited to join the study.
15786182|NCT04563299|Drug|Dextenza 0.4Mg Ophthalmic Insert|All eyes (n=40) will receive anti-VEGF injections for the treatment of AMD, DME and macular edema secondary to RVO. Twenty eyes (one eye per patient) will be randomized to receive Dextenza. The contra-lateral eye (Control) will receive a sham dilation.
15786183|NCT04563299|Drug|Prednisolone Acetate|All eyes (n=40) will receive anti-VEGF injections for the treatment of AMD, DME and macular edema secondary to RVO. Twenty eyes (one eye per patient) will be randomized to receive Dextenza. The contra-lateral eye (Control) will receive topical corticosteroids (prednisolone acetate 1%) QID tapered over 4 weeks (QID/ 1 week, TID/ 1 week, BID/1 week, QD/ 1 week).
15786210|NCT04563039|Device|Acoustic Enhancer with Ureteroscopy Laser Lithotripsy (URS-LL)|Applaud's Acoustic Enhancer is provided in a lyophilized form. After reconstitution, it is a liquid, containing micron-scale particles that are made of a perfluoroalkane gas core with a lipid shell. The device is intended to be used with cleared/approved pulsed laser systems in fragmenting urinary stones (calculi) in the upper (superior) pole, lower (inferior) pole, and interpolar region of the kidney, pelvis of the kidney, and proximal ureter.
15786211|NCT04563039|Device|Standard Ureteroscopic Laser Lithotripsy|Standard of care ureteroscopic laser lithotripsy
15786184|NCT04563286|Other|questionnaire on life quality|Two sets of 30 PROMs questions will be created. The v-ATTR and wt-ATTR questionnaires will be critically evaluated by the whole panel, taking into account observations and feedback from patients. The 2 scores will be administered to consecutive patients evaluated at dedicated ambulatory clinics of the 4 Institutions. To confirm score reliability and responsiveness, 2 distinct patient cohorts will be recruited. The reliability cohort will be assembled to demonstrate the instrument's test-retest reliability. A second cohort of patients (responsiveness cohort) will be assembled to demonstrate the instrument's responsiveness to changes in clinical status. Patients experiencing a heart failure hospitalization within 6 months will enter the responsiveness cohort at the time of hospital admission.
15786185|NCT04563273|Biological|BCG vaccine 1（0.025mg/0.1ml/person）|Intradermal injection of 0.025mg/0.1ml/person dose BCG.
15786186|NCT04563273|Biological|BCG vaccine 2 （0.05mg/0.1ml/person）|Intradermal injection of 0.05mg/0.1ml/person dose BCG.
15786187|NCT04563273|Biological|BCG vaccine 3（0.075mg/0.1ml/person）|Intradermal injection of 0.075mg/0.1ml/person dose BCG.
15786188|NCT04563273|Biological|BCG vaccine 4 （0.075mg/0.1ml/person）|Intradermal injection of 0.075mg/0.1ml/person dose BCG.
15786189|NCT04563273|Biological|Placebo of BCG vaccine （0.1ml/person）|Intradermal injection of 0.1ml/person dose Placebo.
15786190|NCT04563260|Drug|Normal saline injection|Normal saline 2 mL, intravenous injection
15786191|NCT04563260|Drug|Palonosetron Injection [Aloxi]|Palonosetron 1.5 mL (0.075 mg) + Normal saline 0.5 mL, intravenous injection
15786192|NCT04563247|Diagnostic Test|IgG SARS CoV 2 antibodies|The asymptomatic healthcare workers of high exposure COVID19 areas will be tested for IgG SARS CoV 2 antibodies
15786193|NCT04563234|Behavioral|COFLEX neurocognitive training|The COFLEX training group will then be provided with the cognitive training module and participants will be required to complete a targeted 30-minute daily training until the day of surgery, and then after the surgery, for a total of 6 weeks.
15786194|NCT04563234|Behavioral|Crossword puzzles|The control (crossword puzzles) group will be given a training module, where they can access crossword puzzles on the same platform, and can do puzzles whenever they desire over the 6-week time period.
15786195|NCT04563221|Device|Prostatic artery embolization|Prostatic artery embolization is performed using LC Bead LUMI, which is the investigational device. The particles are administered to the prostatic arteries using either a balloon occlusion or standard microcatheter. Follow-up is performed at 1 month, 6 months, 12 months, and 24 months after intervention.
15786196|NCT04563208|Drug|Placebo|Placebo administered on Days 1-5
15786197|NCT04563208|Drug|DuACT|Day1: RBV 600 mg BID and NTZ 500 mg BID Days 2-5: RBV 400 mg BID and NTZ 500 mg BID
15786198|NCT04563195|Drug|tibulizumab (LY3090106)|subcutaneous injections of 300mg every 2 weeks over a period of 12 weeks
15786199|NCT04563169|Other|Video consultation|The first video consultation with a nurse was planned one week after start with CPAP. Three focus points were discussed during the consultations: 1) adherence (>6 hours per night); 2) rest AHI < 5 (or <10 if age >70), and 3) (improvements in) complaints. If these objectives were achieved after one week, a new consultation was planned three weeks later (four weeks after start). As long as these objectives were not achieved, video consultations were planned weekly (until after four weeks).
15786200|NCT04563156|Diagnostic Test|Lung Function Test|Lung Function Test at 1, 4, 6 and 12 months after discharge. Computerized tomography scan at 6 months after discharge. Cardiopulmonary Exercise Testing at 6 months after discharge
15786202|NCT04563130|Behavioral|Cryocompression|Cryocompression will be administered using ice bags and compression socks/ surgical gloves
15786203|NCT04563104|Diagnostic Test|Lung Ultrasound|We will evaluate the role of lung ultrasound on the duration of antibiotics, we hypothesize that ultrasound imaging may have a role, will be correlated with, procalcitonin (PCT). The created database will help in establishing conclusion and recommendations that will help to improve the antibiotics duration and decrease the resistance.
15786204|NCT04563091|Device|Hemodialysis with online HFR|"Hemodialytic therapy using 240-minute online HFR on Flexya® hemodialysis machine (Medtronic, Mirandola, Italy). The blood flow from vascular access will be maintained at values > 250 ml/minute, the flow of dialysis fluid will be 500 ml/minute. Weight loss during dialytic treatment will be prescribed according to the patient's clinical needs.
~Assess potassium (intra and extra cellular), sodium, bicarbonatemia, calcemia, urea, blood sugar values and ECG every 30 minutes during dialysis and every 60 minutes after dialysis.
~Body impedance analysis at time 0 at 240 minutes, after 60 minutes after the end of dialysis and after 7 hours after the end of dialysis.
~Use of the Natrium sensor (Medtronic, Mirandola, Italy) during HFR dialytic treatment."
15786205|NCT04563078|Device|Transcranial Magnetic Stimulation (TMS)|10-day treatment (2 per day with 10 minute break, 20 sessions in total) of active Transcranial Magnetic Stimulation (TMS). TMS is a noninvasive treatment that uses magnetic fields to induce a small electric current in specific brain regions.
15786206|NCT04563078|Procedure|Sham Transcranial Magnetic Stimulation (TMS)|10-day treatment (2 per day with 10 minute break, 20 sessions in total) of sham control.
15786207|NCT04563065|Other|Exercise program|All sessions will begin with a warm-up of 7-8 minutes composed of mild movements and joint mobility of upper and lower limbs exercises. Then a central part of 35-40 minutes, four types of activities will be included (aerobic work, muscle strengthening, coordination/balance tasks, pelvic floor exercises), finally a section of flexibility, relaxation and final talk (comments and sharing) will be performed (12-15 minutes).
15786208|NCT04563065|Other|Healthy lifestyle advise|This intervention consists of providing infographics and videos with advice on healthy habits throughout the pregnancy process. This type of content will be related to daily physical activity, food recommendations and fundamental exercises to perform during pregnancy.
15786209|NCT04563052|Behavioral|Educational Program on Air Pollution as a Health Risk Reduction Strategy|A power point presentation about the health impact of exposure to fine particulate matter (PM2.5) on health. Pm2.5 is found outdoors and indoors. Information will be reviewed about steps to take for the participants to locate the information using a smart phone and steps to take to decrease exposure to prevent illness such as heart disease or strokes.
15786212|NCT04563026|Drug|DUR-928 30 mg|IV infusion
15786213|NCT04563026|Drug|DUR-928 90 mg|IV infusion
15786214|NCT04563026|Drug|Placebo+ Standard of Care (SOC)|IV infusion
15786217|NCT04563000|Drug|Placebo|0,9 % solution of sodium chloride 100 ml intravenously every 12-hours for 4 consecutive days
15786218|NCT04562987|Behavioral|Physical Activity|Mobile app intervention delivered during chemotherapy for breast cancer that combines goal setting, behavioral monitoring, and goal achievement badges with telecoaching to achieve physical activity prescriptions.
15786219|NCT04562987|Behavioral|Attentional Control|Mobile app intervention delivered during chemotherapy for breast cancer that includes telecoaching on general and cancer-related health topics and basic physical activity monitoring.
15786220|NCT04562974|Device|MRI-scanner|Only one group of 30 participants is constituted. All participants will perform perception and memory tasks inside a MRI-scanner. Functional activity (BOLD signal) will be registered, as well as anatomical and behavioural data.
15786221|NCT04562961|Other|Schizophrenia caregivers qualitative interview|"The semi-structured qualitative interview will be carried out in a focus group or individually for a period of 1 hour. Focus groups are a group interview technique, moderated by a neutral facilitator in the presence of an observer, which aims to collect information on a limited number of pre-defined questions. In this study we foresee groups of 4 to 5 subjects. Focus groups will be privileged because they allow a better elaboration of the participants and therefore a better collection of data. If the focus group is not possible, the visit will be done individually. This interview will be framework-guided and recorded in their entirety and anonymously using a dictaphone and then transcribed the objective verbatim on a computer using word processing software. These transcriptions will be called the verbatims. The source data recorded using a dictaphone will be stored in secure, locked cabinets located within the investigation center."
15786222|NCT04562935|Other|admission to pediatric intensive care with mechanical ventilation|admission to pediatric intensive care with mechanical ventilation
15786223|NCT04562922|Dietary Supplement|Lifemel|
15786224|NCT04562909|Device|Neurocom balance master device|With the Modified Sensory Balance Interaction Clinical Test, the static balance will be examined by measuring the torso oscillation velocities while the eyes are open and the eyes closed on the stable rigid and unstable foam floors, and the dynamic balance will be examined with the sit-stand test, which is the basic motor activity in daily life, and the parameters will be measured on the same device.
15786225|NCT04562896|Device|Custom Carbon Fiber Dynamic Orthosis (CDO)|The custom carbon fiber dynamic orthoses will consist of a semi-rigid foot plate, a posterior carbon fiber strut, and a proximal cuff below the knee.
15786226|NCT04562883|Other|The way of Cumulus-oocyte complexes (COC) culture|Cumulus-oocyte complexes (COC) will be cultured in CAPA-IVM standard conditions: 24 hrs capacitation followed by 30h maturation. The first group will be culture in pools (group culture). The second group will be culture individually in 20µl droplets.
15786227|NCT04562870|Drug|Selinexor|Unit Dose Strength: 20 mg; Dose Formulation: Tablet; Dosage Level: 60 mg, QW; Route of Administration: Oral
15786228|NCT04562870|Other|Physician's Choice Treatment|Physician's choice treatment may include ruxolitinib retreatment, fedratinib, chemotherapy (e.g., hydroxyurea), anagrelide, corticosteroid, hematopoietic growth factor, immunomodulatory agent, androgen, interferon (all as per clinical practice) and may include supportive care only with no MF treatment; no investigational therapies are allowed.
15786229|NCT04562857|Behavioral|Moderate intensity interval training (MITT)|interval exercises (intervention) on bicycle for patients with AF and OSA or AF with CSA for 10 weeks, 3 times/week for duration of 30-45 min/ session.
15786230|NCT04562844|Other|sociale cognition|several social cognition test
15786231|NCT04562831|Dietary Supplement|EH301 (Nicotinamide Riboside/Pterostilbene)|Comparison of 2 different dosages with placebo in newly diagnosed ALS patients and comparison of high dose with placebo in earlier ALS patients.
15786232|NCT04562818|Diagnostic Test|Diagnosis|Determine the number of center that are able to process PCR or FISH/Karyotype for PML/RAR or t(15;17)
15786233|NCT04562818|Diagnostic Test|Molecular and Karyotype|To realize the need of having more center we the technology to perform all of these tests
15786234|NCT04562818|Diagnostic Test|Leucocytes|
15786235|NCT04562805|Device|DynamX Bioadaptor|DynamX Bioadaptor Treatment
15786236|NCT04562805|Device|Resolute Onyx|Resolute Onyx Treatment
15786238|NCT04562779|Drug|Naltrexone 380 MG|XR naltrexone to be given once prior to hospital discharge
15786239|NCT04562779|Drug|Ketamine Hydrochloride|IV ketamine infusion to be given once prior to hospital discharge
15786240|NCT04562779|Behavioral|Enhanced linkage|Includes in-hospital intake at outpatient addiction clinic plus contingency management related to follow-up
15786241|NCT04562766|Drug|Rilzabrutinib|400mg Caplet
15786242|NCT04562766|Drug|Placebo|400mg Caplet
15786243|NCT04562753|Procedure|Maïa® TMC Prosthesis (Lépine Groupe)|Patients undergoing thumb basal joint arthroplasty using Maïa® TMC prosthesis as treatment of osteoarthritis.
15786244|NCT04562753|Procedure|APL Suspensionplasty|Patients undergoing thumb basal joint arthroplasty using APL Suspensionplasty as treatment of osteoarthritis.
15786245|NCT04562740|Device|ABLUMINUS DES drug eluting stent|Following successful plain balloon angioplasty of the arterial lesion, (defined as <30% residual stenosis after treatment at rated burst pressure of the angioplasty balloon), the ABLUMINUS stent will be deployed at the lesion as per Instructions for Use (IFU) after appropriate sizing using the diameter of the plain balloon angioplasty. After deployment of the ABLUMINUS stent, further balloon angioplasty of the stent will be performed, using the same diameter standard balloon catheter at 2 minutes inflation, to ensure adequate moulding and expansion of the stent.
15786246|NCT04562727|Drug|Chemotherapy|perioperative chemotherapy or postoperative chemotherapy
15786247|NCT04562714|Device|FreeStyle Libre Flash Glucose Monitor|The FreeStyle Libre FGM device consists of a skin-worn disposable sensor that automatically measures and continuously stores glucose readings. The sensor is placed by a single-use applicator and is activated by a wireless scan with a handheld reader. It is designed to stay on the body for up to 14 days, and can be worn under clothing. After a 1-hour warm-up period, the sensor takes automatic measurements of glucose every 15 minutes for up to 14 days. The device collects the interstitial glucose values and stores them for subsequent upload at the end of the 14-day wear period. With each scan, users receive their glucose reading; the last eight hours of glucose data; and an arrow illustrating the direction their glucose is heading.
15786248|NCT04562714|Other|Diabetes self-management education|"The DSME curriculum is compromised of:
~Review of weekly glucose report (Trend glucose report from Libreview for intervention group; and weekly glucose report in log book format from their glucose monitoring software for control group)
~Education modules for both in-person and remote delivery;
~Handouts to support the curriculum objectives; and
~Blood glucose monitoring challenges to stimulate behaviour change and reinforce learning."
15786249|NCT04562688|Other|CICADAS and then PEERS|Participants will complete sensory processing assessments and neuroplasticity-based social cognitive training (NB-SCT) exercises on a digital device for a total of 40 hours. The CICADAS app captures user-specific sensory processing abnormalities (SPA) through 10 brief computerized assessments. The data from these assessments guide and personalize the delivery of 10 NB-SCT exercises. After 16 weeks, participants will then crossover to PEERS, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians.
15786250|NCT04562688|Other|PEERS + CICADAS and then no-contact|Participants will complete both PEERS and CICADAS study activities. Participants will complete sensory processing assessments and neuroplasticity-based social cognitive training (NB-SCT) exercises on a digital device for a total of 40 hours. The CICADAS app captures user-specific sensory processing abnormalities (SPA) through 10 brief computerized assessments. The data from these assessments guide and personalize the delivery of 10 NB-SCT exercises. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
15786251|NCT04562688|Other|PEERS + Active Comparator and then no-contact|Participants will complete both PEERS and Active Comparator study activities. Participants will engage in computerized, casual video games for a total of 40 hours. Participants will also complete the 10 sensory processing abnormalities (SPA) computerized assessments. In addition, participants will be asked to attend weekly 1-hour group sessions led by a PEERS clinician. Each PEERS group session will consist of a minimum of 3 participants and will meet as a group using Zoom. PEERS teaches how to solve real-life social dilemmas, appraise affect and social contexts, and initiate and maintain conversations while receiving feedback from peers and clinicians. After 16 weeks, participant will crossover to No-Contact with no active intervention.
15786252|NCT04562675|Behavioral|LHA intervention|For the IG, a 4-hour lesson consisting of 4 chapters and leaflets was delivered over 4 weeks, with one chapter per hour per week. Each LHA visited the assigned mother in the IG four times in a 4-week period.
15786253|NCT04562675|Other|brochure-only|brochure-only for control group (CG)
15786254|NCT04562662|Device|mediVR KAGURA|Approximately 20 min mediVR KAGURA-guided rehabilitation
15786255|NCT04562649|Device|Wise App with medication adherence reminders|The Intervention group will receive the Wise App that delivers medication adherence reminders.
15786256|NCT04562649|Behavioral|CHW Sessions|The Intervention group will complete sessions with a community health worker (CHW).
15786257|NCT04562636|Other|Environmental message|Participants will be randomized to view a set of four messages about the environmental harms of meat production from the Meatless Monday campaign.
15786258|NCT04562636|Other|Health message|Participants will be randomized to view a set of four messages about the health harms of meat consumption from the Meatless Monday campaign.
15786259|NCT04562636|Other|Neutral Message|Participants will be randomized to view a set of four messages about checking their credit score.
15786260|NCT04562610|Drug|Intravenous Infusion group|The intravenous infusion group will receive two medications via the intravenous infusion route. These medications are Ofirmev ( acetaminophen ) 1,000mg and tranexamic acid 2,000 mg , an antifibrinolytic drug. In addition to these drugs, study subjects will receive Celecoxib 200mg by mouth and Gabapentin 600 mg by mouth prior to operation.
15786261|NCT04562610|Drug|All oral administration group|Subjects in the oral administration group will receive the following pre-emptive analgesic drugs, acetaminophen 1,000mg, Celecoxib 200mg and gabapentin 600mg via the oral route prior to operation. In addition they will receive the antifibrinolytic drug, tranexamic acid 2,000mg via an oral route as well prior to operation.
15786262|NCT04562597|Drug|Dose Response Curve Placebo|5-10 participants will be randomized to the placebo group to estimate the dose response curve and to identify the optimal dose.
15786263|NCT04562597|Drug|Dose Response Curve N-acetylcysteine 50 mg/kg|5-10 participants will be randomized to the N-acetylcysteine 50 mg/kg group to estimate the dose response curve and to identify the optimal dose.
15786264|NCT04562597|Drug|Dose Response Curve N-acetylcysteine 100 mg/kg|5-10 participants will be randomized to the N-acetylcysteine 100 mg/kg group to estimate the dose response curve and to identify the optimal dose.
15786265|NCT04562597|Drug|Dose Response Curve N-acetylcysteine 150 mg/kg|5-10 participants will be randomized to the N-acetylcysteine 150 mg/kg group to estimate the dose response curve and to identify the optimal dose.
15786266|NCT04562597|Drug|Opioid Reduction with Optimal N-acetylcysteine Dose|Once the optimal N-acetylcysteinedose is identified, 10-15 participants will be randomized to the optimal dose (50,100, or 150 mg/kg) to estimate the difference in opioid consumption between patients administered optimal N-acetylcysteine dose or placebo.
15786267|NCT04562597|Drug|Placebo|10-15 Participants will be randomized to placebo to estimate the difference in opioid consumption between patients administered optimal N-acetylcysteine dose or placebo.
15786268|NCT04562584|Device|MyHomeDoc|MyHomeDoc device SpO2 measurements and parallel blood gas analysis to determine oxyhemoglobin saturation (SaO2) using an ABL-90 multi-wavelength oximeter.
15786269|NCT04562571|Other|Charter & patient information leaflets|Public commitment charter, non-prescription pad, information leaflet in case of antibiotic prescription
15786270|NCT04562558|Drug|Methotrexate|50mg intramuscularly on Days 1, 3, 5, 7 . Repeat every 14 days
15786271|NCT04562558|Drug|Leucovorin|15mg intramuscularly on Days 2, 4, 6, 8. Repeat every 14 days
15786272|NCT04562558|Drug|Dactinomycin|1.25mg/m2 (2mg max dose)intravenous every 14 days.
15786273|NCT04562545|Device|Modified Twin Block|a modified twin block design including jack screws to facilitate incemental advancement
15786274|NCT04562545|Device|Twin Block Appliance set to maximum bite|a traditional twin block set to maximum bite advancement at start of treatment
15786275|NCT04562532|Device|Microport Firehawk stent|MicroPort Firehawk biodegradable polymer rapamycin target eluting stent
15786276|NCT04562532|Device|2nd generation DES (XIENCE family, Promus family, Resolute/Onyx family/Endeavor, and Orsiro stent)|"Everolimus eluting stents (Xience family - Abbott Vascular, Promus family- Boston Scientific, Synergy - Boston Scientific)
~Zotarolimus eluting stents (Resolute/Onyx family and Endeavor- Medtronic)
~Sirolimus eluting stents (Orsiro- Biotronik)"
15786277|NCT04562519|Device|TENS|Patients of this group will receive 20 minutes of extra oral TENS over skin of bilateral parotid glands (3 sessions weekly for 3 weeks)
15786278|NCT04562506|Device|rTMS with H-coil|Deep repetitive transcranial manetic stimulation or sham stimulation with H-coil
15786279|NCT04562506|Device|Sham rTMS stimulation with H-coil|Sham rTMS stimulation
15786280|NCT04562493|Procedure|Transforaminal Epidural injection|Transforaminal injection will be performed under fluoroscopy guidance. The patient will be placed in the prone position and draped in the sterile manner. A 22-gauge, 3.5-inch spinal needle will be used. The selected patients will receive transforaminal epidural injection of the drug
15786281|NCT04562480|Radiation|Hypofractionated Radiation Therapy|Undergo hypofractionated radiation therapy
15786282|NCT04562480|Other|Quality-of-Life Assessment|Ancillary studies
15786283|NCT04562480|Other|Questionnaire Administration|Ancillary studies
15786284|NCT04562480|Procedure|Resection|Undergo surgical resection
15786285|NCT04562467|Drug|Icosapent Ethyl 1000 MG Oral Capsule [Vascepa]|2 x 1g capsules BID as per REDUCE-IT
15786286|NCT04562454|Other|Specific diet|use a specific diet in different days with CGM to konw GI of different food in diabetes
15786287|NCT04562441|Drug|Axitinib|Axitinib: 5 mg bd po Day 1 to Day 28
15786288|NCT04562441|Drug|Avelumab|Avelumab: 10 mg/kg Day 1 to Day 15 every 4 weeks
15786289|NCT04562428|Drug|Xiang Sha Liu Jun Zi Decoction dry powder|the principles of Chinese medicine treatment areinvigorating Pi, regulating qi, dissipating dampness and appetizing wei
15786290|NCT04562428|Drug|XSLJZ Placebo|XSLJZ Placebo
15786291|NCT04562415|Device|Active Repetitive Transcranial Magnetic Stimulation Therapy|10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and inhibitor rTMS was applied with a frequency of 1 Hz consisting of 1200 pulses for 20 minutes. In addition, within 30 minutes after TMS sessions, all patients underwent 10 sessions of joint range of motion, stretching, strengthening, balance and coordination exercises, hand rehabilitation and daily living activities.
15786292|NCT04562415|Device|Active Continuous Theta Burst Stimulation Therapy|10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and cTBS was administered for a total of 600 pulses consisting of 3 burst stimulations of 50 Hz repeated every 200 milliseconds for 40 seconds. In addition, within 30 minutes after TMS sessions, all patients underwent 10 sessions of joint range of motion, stretching, strengthening, balance and coordination exercises, hand rehabilitation and daily living activities.
15786293|NCT04562415|Device|Sham Continuous Theta Burst Stimulation Therapy|10 sessions of intact hemispheric upper extremity motor area (M1) were targeted and sham cTBS was administered for a total of 600 pulses consisting of 3 burst stimulations of 50 Hz repeated every 200 milliseconds for 40 seconds. In addition, within 30 minutes after TMS sessions, all patients underwent 10 sessions of joint range of motion, stretching, strengthening, balance and coordination exercises, hand rehabilitation and daily living activities.
15786294|NCT04562402|Procedure|Phacoemulsification|cataract surgery via phacoemulsification
15786295|NCT04562402|Procedure|Endoscopic cyclophotocoagulation|Endoscopic ablation of the ciliary body
15786296|NCT04562389|Drug|Selinexor|Formulation: 20 mg Tablet; Dose: 20, 40 (2 tablets of 20 mg), 60 mg (3 tablets of 20 mg); Route of Administration: Oral
15786297|NCT04562389|Drug|Ruxolitinib|Formulation: 5, 10 mg Tablet; Dose: 15, 20 mg; Route of Administration: Oral
15786298|NCT04562376|Other|High-intensity resistance training|The program consists of high-intensity resistance training for 60 minutes twice a week (group A) during 12 weeks
15786299|NCT04562376|Other|Low frequency of high-intensity resistance training|The program consists of high-intensity resistance training for 60 minutes once a week (group B) during 12 week
15786301|NCT04562350|Other|XatJove Anoia Aplication|All students (age 12-16 years) from middle school and high school in the sanitary region of Anoia, province of Barcelona, will access a Platform ( ABH Health), where the users will enter specific registration data ( age, sex..etc), after every visit the users will be provided with a 6 multiple choice questionary and asked to punctuate in a scale from 1 to 10, the satisfaction of the service provided. Appart from this data, researchers will use a software to register specific Health-related words and classify them as Health-problems. While Osona students will attend face-to-face consultations as usual, apart from this data,Registrations will be reviewed later and specific search techniques and strategies will be coded. A qualitative review will be performed too.
15786302|NCT04562337|Drug|SHR1316|Anti-PD-L1 antibody
15786303|NCT04562337|Drug|Chemotherapy|Carboplatin
15786304|NCT04562337|Drug|Chemotherapy|etoposide
15786305|NCT04562337|Radiation|Radiation therapy|thoracic radiation therapy ,TRT
15786308|NCT04562311|Drug|Chidamide with tislelizumab|Chidamide: 30mg orally BIW. Immunotherapy: tislelizumab,the fixed dose of 200 mg IV. Treatment cycles are repeated every 3 weeks.
15786341|NCT04561960|Drug|Fluoride toothpaste|Fluoridated paste containing 1450ppm NaF
15786342|NCT04561960|Drug|Toothpaste Product|Non Fluoridated toothpaste with extract of miswak ( Dabur, miswak tooth paste)
15786310|NCT04562285|Diagnostic Test|Serologic immunoassays to SARS-CoV-2 antibodies|Detect and characterize antibodies to SARS-CoV-2
15786311|NCT04562272|Procedure|LV mechanical unloading by Impella-CP|The patients will receive Impella-CP for 36-48 hours. The pump speed and LV unloading will be guided by PCWP (Swan-Ganz catheter)
15786312|NCT04562259|Radiation|Verification of Kimmerle's anomaly by x-ray methods of research|In patients with Kimmerle's anomaly, using computed tomography of the brain with the capture of the upper cervical spine and cervical spine, it is planned to determine at what age this pathology is more common, localization of the anomaly (right, left), complete or incomplete form of the anomaly.
15786313|NCT04562246|Diagnostic Test|Serologic assays for antibodies to SARS-CoV-2|Beckman Coulter and Roche automated immunoassays
15786314|NCT04562233|Behavioral|Online-delivered physical activity intervention.|Participants randomized to the intervention arm will complete this protocol. Participants will engage in 12, weekly, supervised, exercise sessions using Zoom with the exercise trainer
15786315|NCT04562233|Behavioral|Printed, individualized resistance-based physical activity program.|Without the supervision of an exercise trainer, participants will be given a printed, individualized resistance-based physical activity program to complete over the course of 12 weeks.
15786318|NCT04562207|Diagnostic Test|Screening for respiratory virus infection|Nasopharyngeal swab for screening for respiratory virus infection before surgery
15786319|NCT04562194|Device|NeVa Stent Retriever|mechanical neurothrombectomy
15786320|NCT04562181|Other|Bispectral index and qCON/qNOX monitoring|This study will characterise the bispectral index data and qCON/qNOX index data in 30 patients during the operation and first postoperative night
15786321|NCT04562168|Diagnostic Test|Autoderm® dermatology search engine (ML model) testing|GP using a smartphone camera will take an image of the skin problem and will use the Autoderm ML interface to upload the anonymized image. The obtained predicted diagnosis will be recorded in case report form.
15786322|NCT04562155|Drug|BAY1817080|Study drug BAY1817080 will be administered orally as tablet.
15786323|NCT04562155|Drug|Placebo|Matching Placebo for BAY1817080 will be administered orally as tablet.
15786324|NCT04562142|Device|CAD-det|CAD-det test will be done on participants with suspected CAD clinically referred for ICA at a participating clinical investigation site.
15786325|NCT04562129|Drug|Interleukin-2|High dose interleukin-2 (HD IL2) administered week 1 and 4 of each course (approximately 12 weeks)
15786326|NCT04562129|Drug|Ipilimumab|Low dose Ipilimumab given at time of HD IL2 administration on day 1 of the first 2 cycles of each course.
15786327|NCT04562129|Drug|Nivolumab|Nivolumab will be given at a dose of 480 mg IV week 7 of each course.
15786328|NCT04562116|Drug|Nemolizumab|Nemolizumab 30 mg will be administered as SC injections.
15786329|NCT04562116|Drug|CYP 450 Substrates|CYP substrates (Caffeine, Warfarin Sodium, Midazolam, Omeprazole, and Metoprolol Tartrate) will administered orally at Week 0 (Day 1) and Week 10 as per the commercially available prescribing information.
15786330|NCT04562103|Drug|Epinephrine / Ropivacaine|In this group quadratus lomborum block was performed with 0.375% ropivacaine+100 mcg epinephrine.
15786331|NCT04562103|Drug|Ropivacaine|In this group quadratus lomborum block was performed with plane 0.375% ropivacaine.
15786333|NCT04562064|Device|corneal tomography scans|corneal tomography scans of the two corneal surfaces were obtained preoperatively and postoperatively with a rotating Scheimpflug imaging system
15786334|NCT04562051|Other|prophylaxis regimen|All recipients were divided into two groups: stratified prophylaxis group based on donors' and recipients' characteristics and routine prophylaxis group based on clinical experience
15786335|NCT04562038|Behavioral|Young Children's Participation and Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO)|The Young Children's Participation in Environment Measure (YC-PEM) is an evidence-based option for comprehensive proxy assessment of a young child's current and desired participation in occupations across home, daycare, and community settings. The YC-PEM is an electronic patient-reported outcome (e-PRO) that provides individual caregivers a valid, reliable, and feasible way to communicate information about their child's current participation in home and community activities and areas of participation need. The gained information is then summarized and shared with the child's EI provide team to identify intervention priorities and goal attainment strategies in partnership with families. For quality improvement, EI programs can aggregate the YC-PEM e-PRO data to examine trends in participation as a function of EI service use. It is therefore a promising electronic health systems intervention to enhance the parent-practitioner relationship, and an NIH common data element for trials.
15786336|NCT04562025|Drug|UC-MSCs|3 times of UC-MSCs (1*10E6 UC-MSCs/kg body weight/100mL saline containing 1% human albumin intravenously at week 1,week 2, week 3).
15786337|NCT04562025|Drug|Placebo|3 times of cell-free stem cell suspension (saline containing 1% human albumin/100mL intravenously at week 1, week 2, week 3).
15786338|NCT04561999|Device|Elastography|Performance of Ultrasound, Elastography
15786339|NCT04561986|Drug|Tocilizumab|Tocilizumab is a recombinant humanized monoclonal antibody directed against the human interleukin-6 (IL-6) receptor
15786340|NCT04561973|Behavioral|numerical rating scale|Patients seen for routine planned visits complete a self-administered retrospective questionnaire about pain during the last 3 months, and a prospective diary during the two weeks following the visit.
15786343|NCT04561960|Device|Toothbrush|Colgate classic clean Soft bristled toothbrushes, 19.05 x 1.27 x 1.91 cm
15786344|NCT04561960|Device|Miswak Stick|A miswak stick of 15 cm length
15786345|NCT04561947|Procedure|Tunnel technique|After local anesthesia, the exposed root surfaces were mechanically treated with curettes. A tunnelling knives were used to prepare a split-thickness flap and create a continuous tunnel in the buccal soft tissues, following the intrasulcular incision with a #69 microblade. Split-thickness flap preparation was performed to beyond the mucogingival junction with supraperiosteal dissection by placing the tunneling knives to the soft tissue. This process was repeated by entering through the sulcus of each tooth. After the elevation of the flap, a papilla elevator placed under the flap was entered through the sulcus to mobilize the papilla, the periosteum at the base of the papilla was cut, and the full-thickness flap was elevated.
15786346|NCT04561947|Procedure|Connective tissue graft|CTG was harvested using the de-epithelialized connective tissue graft technique. The epithelial tissue on the outer surface of the graft was removed with a 15 blade and a 1-mm-thick graft was obtained.
15786347|NCT04561947|Other|Concentrated growth factor membrane|Intravenous blood samples were collected in without anticoagulant 10-mL tubes and immediately centrifuged in a CGF centrifuge machine using a program with the following features: 30 ̋ acceleration, 2 min at 2700 rpm, 4 min at 2400 rpm, 4 min at 2700 rpm, 3 min at 3000 rpm, and 36 ̋ deceleration and stop. After centrifugation, four layers were formed in the tube: the serum layer at the top, the second buffy coat layer, the third CGF layer containing GF and unipotent stem cells, and the red blood cell layer at the bottom. The resulting CGF was removed from the tube and separated from the red blood cell layer using microsurgical scissors.
15786348|NCT04561934|Drug|Silver diamine fluoride|Application of 38% SDF (Riva Star, SDI, Bayswater, Australia), and Resin modified glass ionomer cement (RMGIC) (Fuji Lining LC; GC, Tokyo, Japan) prior resin composite restoration (Filtek Z350 XT,3MESPE).
15786349|NCT04561934|Other|resin modified glassionomer cement|resin modified glassionomer cement
15786350|NCT04561921|Drug|Magnesium sulfate|patients will be given an IANB injection by adding 0.18 mL of 10% magnesium sulphate to 1.8 ml of 2% mepivacaine HCL with Levonordefrin HCl 1:20000/ 1.8 ml , after withdrawal of 0.18ml from the local anesthetic carpule by using a 100 IU insulin syringe
15786351|NCT04561921|Drug|Mepivacaine-Levonordefrin Hydrochloride|patients will be given an IANB injection by adding 0.18 mL of sterile distilled water to 1.8 ml of 2% mepivacaine HCL with Levonordefrin HCl 1:20000/ 1.8 ml , after withdrawal of 0.18ml from the local anesthetic carpule by using a 100 IU insulin syringe
15786352|NCT04561908|Device|Transcatheter microguidewire drilling|Transcatheter microguidewire drilling with microguidewire (0.014-inch BMW; Abbott, Plymouth, Minnesota, USA), 3.0 mm×15 mm balloon (NC TREK, Abbott, Plymouth, Minnesota, USA) and 6F MP1 guidecatheter .
15786353|NCT04561895|Genetic|DNA extraction|investigation of DNA polymorphism in patients suffering from NAFLD
15786354|NCT04561882|Device|Transcatheter exclusion of atrial septal aneurysm|"Through transseptal perforation, transcatheter reconstruction of atrial septum was achieved with PFO occluder to cover the whole ASA.
~Device: Cardi-O-Fix™ patent foramen ovale occluder (Starway Medical Technology, Inc. Beijing, CN)"
15786355|NCT04561856|Drug|Dexamethasone|Intravenous 4mg
15786356|NCT04561856|Drug|Dexamethasone|Perineural 4mg
15786357|NCT04561856|Drug|Placebo|Normal Saline 2ml
15786358|NCT04561843|Diagnostic Test|pelvic floor ultrasound|2D and 3D trans-perineum ultrasound examinations will be performed by single examiner who was blind to clinical data, using a GE Voluson 730 machine (GE Medical System Kretz Technik, Zipf, Austria) with a RAB 4-8 MHz curved array volume transducer. In the supine position, with flexed and slightly abducted hips after urine voiding. The transducer was placed on the perineum, in the mid sagittal plane with minimal pressure being applied after covering it with an un-powdered glove or thin plastic wrap for hygienic reasons
15786359|NCT04561830|Procedure|laparoscopic-assited excision of mesorectum with pelvic lymph nodes excision|"We performed laparoscopic dissection of the lateral pelvic lymph node for thirty patients while we performed open lateral pelvic lymph node dissection for the remaining thirty patients.
~Performed surgical approaches were abdominoperineal resection, internal sphincter resection, and low anterior resection. All performed surgical procedures included lateral pelvic lymphadenectomy in addition to performing total mesorectal excision.
~Choosing whether to perform unilateral or bilateral lymphadenectomy depends on lymph nodes invasion by cancer was on one side or both sides."
15786360|NCT04561817|Drug|Ipatasertib|400mg PO daily: day 1-21 of 28 day cycle
15786361|NCT04561817|Drug|Paclitaxel|80 mg/m2 IV weekly: day 1, 8, 15 of 28 day cycle
15786362|NCT04561804|Procedure|laparoscopic sleeve gastrectomy (LSG) and laparoscopic single anastomosis gastric bypass (LSAGB)|"The participants will receive nutritional recommendations for a low carbohydrate, low glycemic load, and isocaloric diet. The diet will be composed of carbohydrates (CHO;35%), fats (40-50%), and proteins (20-25%), and will be tailored to individual preferences and calorie requirements. The number of CHO, protein and fat servings will be determined based on the recommended total energy requirements for age, calculated on the basis of dietary reference intake (DRI). Participants will not be instructed to restrict calories, but to reduce carbohydrate based on their glycemic load.
~The subjects will be instructed about appropriate food choices, and each subject was provided a diet information booklet containing food list, sample menus and recipes"
15786363|NCT04561791|Device|Tethered Capsule Endomicroscopy|Participants will be asked to swallow the TCE. They may use mild numbing spray, and lubrication spray to help swallowing. Imaging will be conducted once the TCE is past the pharynx. We will advance the TCE until the stomach and then slowly pull the TCE back up the esophagus. This may be repeated twice.
15786364|NCT04561778|Device|HOT-CRT|Subjects enrolled in the study will receive a permanent cardiac implantable electronic device (CIED) (CRT-pacemaker or CRT-defibrillator) as clinically indicated. Subjects randomized to HOT-CRT will have His bundle pacing lead placed initially to achieve CRT. If complete resynchronization is achieved (BBB normalization) but capture thresholds are high (1.5-2V), the lead may be placed in the distal conduction system (left bundle branch area). If only partial QRS narrowing is achieved, a coronary sinus lead may be placed and left ventricular timing may be optimized to achieve maximal resynchronization.
15786365|NCT04561778|Device|Biventricular Pacing|Subjects enrolled in the study will receive a permanent CIED (CRT-pacemaker or CRT-defibrillator) as clinically indicated. Subjects randomized to Biventricular pacing will undergo left ventricular lead placement in the coronary sinus venous branches.
15786366|NCT04561765|Device|iCanCope|The iCanCope mobile and web-based self-management program has been empirically evaluated for multiple painful diseases
15786367|NCT04561765|Device|iCanCope+Contingency Management|In addition to the iCanCope-NF activities outlined above, individuals will be rewarded with incentives (contingency management) such as points that are redeemable for prize-based gift card vouchers. Points will be accrued through access to new sections, daily check-ins, and engagement of the mobile application. Based on research, the total amount of money that can be earned by the patient over the course of the two months is 50 dollars USD.
15786368|NCT04561752|Drug|ZN-c5|ZN-c5 is the study drug.
15786369|NCT04561739|Device|Swide Paclitaxel coated balloon|"The Swide balloon is a paclitaxel-eluting rapid exchange balloon catheter for PTCA. Paclitaxel is the pharmacologically active substance for anti-neointima, whereas iopromide, a well-tolerated nonionic x-ray contrast agent, acts as a release-supporting additive.
~The active drug coating is located on the surface of the balloon, which contains 3 μg Paclitaxel per 1 mm2. The spray coating of the mixture of paclitaxel and iopromide of the Swide is via ultrasound, with the crystal size<2um."
15786370|NCT04561739|Device|Firebird2 Sirolimus eluting stents|The device has a backbone of L605 cobalt chromium. The stent has a open cell, in-phase, peak-to-valley design. The strut thickness is 86 μm and has a stent profile less than 1.12mm. The polymer coating of the stent is a styrene-butadiene block copolymer. The antiproliferative drug concentration is at 9 ug/mm, which 80% of the drug is released by 30 days.
15786371|NCT04561739|Drug|Aspirin|Aspirin is required for 3 months be a part of the dual antiplatelet therapy (DAPT) after PCI.
15786372|NCT04561739|Drug|Ticagrelor or Clopidogrel for DCB|Ticagrelor or Clopidogrel is required for 6 months to be a part of the dual antiplatelet therapy (DAPT) after PCI.
15786373|NCT04561739|Drug|Ticagrelor or Clopidogrel for DES|Ticagrelor or Clopidogrel is required for 12 months to be a part of the dual antiplatelet therapy (DAPT) after PCI.
15786374|NCT04561726|Other|Connective Tissue Manipulation|Connective tissue manipulation is a soft tissue manipulative technique and also a reflex therapy which is characterized by localised and specific strokes performed in where the fascia is superficial or palpable. A shear force is created between the skin-underlying fascia or dermis-hypodermis and angulatory force is applied to the collagen fibers to produce reflex and mechanical effects.
15786375|NCT04561726|Other|Exercise|The purpose of the given home exercises is to increase motor ability in activities such as standing, walking and posture, to increase muscle strength and also to elongate muscles. Exercises progressed day by day according to the adaptation of the motor system and muscle strength to the exercises.
15786376|NCT04561713|Procedure|Virtual reality task|Virtual reality application in an immersive room (CAVE) in three dimensions to assess child's sustained attention in a dynamic environment that is as close as possible to everyday situations.
15786377|NCT04561700|Diagnostic Test|Reporting of sucking patterns captured by Instrumented Bottle|In the intervention group, data on nutritive sucking and feeding cues captured by the Instrumented Bottle will be made available to speech therapists to document the feeding session and provide written recommendations in their weekly report.
15786378|NCT04561700|Diagnostic Test|Control|In the control group, the information captured by the Instrumented Bottle will not be made available to speech therapists and therefore, will not be used to document a feeding session or provide weekly recommendations.
15786379|NCT04561687|Drug|Montelukast|Montelukast and nasal budesonide
15786380|NCT04561687|Drug|Azelastine|Azelastine and nasal budesonide
15786381|NCT04561687|Drug|Budesonide|To all groups
15786382|NCT04561687|Drug|Placebo|Placebo and nasal budesonide
15786383|NCT04561674|Other|Implementation of web-based patient education|Web-Based Patient Education on Colostomy and Ileostomy (WBPECI) was developed in accordance with the principles of the ADDIE instructional design. The web-based education was designed in line with these learning objectives determined. The content of the website was developed in light of the opinions sought from five subject experts. The WBPECI content includes a total of 7 videos, 1 animation with sound, 1 forum and 1 consultation page
15786384|NCT04561661|Procedure|Percutaneous pinning|Closed reduction, percutaneous pinning and plaster
15786385|NCT04561661|Procedure|Conservative treatment|Closed reduction, custom made orthosis and early mobilization
15786386|NCT04561648|Drug|Unfractionated Heparin|Before removing the introducer sheath, the 2nd operator will pass the missing UFH dose to the first operator to reach 100 IU per kg of body weight in a 10 ml syringe mixed with 0.9% saline solution. The blinded first operator will administer this without knowing if it is saline or the supplemental dose of unfractionated heparin.
15786387|NCT04561635|Dietary Supplement|Multiple-micronutrients supplement|Multiple-micronutrients supplement with 15 micronutrients
15786388|NCT04561622|Behavioral|Emotional Stroop Task|"Classic Stroop task The subject names one of the 3 colors of the crosses on a sheet.Then, the subject must read the words written on the sheet for 45 seconds.These are the words: RED, BLUE and GREEN, written in black color. The subject must name the color of the word.
~Emotional Stroop task This is a computed task in which the patient is asked to answer both as accurately and as quickly as possible.
~The target stimulus is an emotional face of joy or anger, surmounted by the word joy or anger.The subject must respond using the arrow corresponding to the face he sees.
~A training phase is offered to the subject.
~3 / Categorization task For each trial the participant will visualize a short emotional film or not. Then, the participant will have to choose, the emotion corresponding to what he just saw. A training period is offered too."
15786389|NCT04561609|Other|Transcutaneous CO2 application|"Patients lie on examination tables. Lower extremities of the patients are isolated in a therapeutic wrap (single use, low-density, made from biocompatible polyethylene), sealed at the waist. After this, air is first pumped out of the therapeutic wrap, then the wrap was filled with 99.9% CO2 gas. The therapy lasts for 45 minutes.
~Each patient from the study group will receive CO2 therapies - four weeks (meaning 20 CO2 therapies that were performed on workdays only)."
15786390|NCT04561609|Other|Placebo treatment|Each patient from control group will have therapeutic wrap filled with air instead of CO2. Patients from control group will also receive 20 therapies (4 weeks on workdays only), that will also last 45 minutes.
15786431|NCT04561271|Other|foot reflexology|Patients will receive one session of foot reflexology with a nurse who received a specific formation. The session lasts 15 to 20 minutes, patients seated, half seated or in supine position. A neutral oil will be used. The technique associates specific movements of foot reflexology. The session is accompanied by relaxing music.
15786391|NCT04561596|Device|OnComfort autohypnosis|"Participant arrive in our day care clinic and is prepared as any other patient in interventional radiology. The investigator will collect the signed informed consent form and proceed to randomization.
~The participant will then fill the pre and post-operative anxiety and pain questionnaire.
~The percutaneous vascular procedure will be performed as usual except for the virtual reality mask and autohypnosis software that will run during the whole intervention.
~Pain and anxiolytic medication are provided if needed during the intervention. Immediately after the intervention, the participant will fill the post-operative anxiety and pain questionnaire. The participant will be instructed to report anxiety and pain felt during the intervention.
~A clinical visit at 3 month is conducted as part of the standard clinical protocol. The participant will fill a 3rd questionnaire about the remembered anxiety and pain during the intervention."
15786392|NCT04561596|Other|Treatment as usual, without the OnComfort autohypnosis system|"The Participant arrive in our day care clinic and is prepared as any other patient in interventional radiology. The investigator will collect the signed informed consent form and proceed to randomization.
~The participant will then fill the pre and post-operative anxiety and pain questionnaire.
~The percutaneous vascular procedure will be performed as usual. Pain and anxiolytic medication are provided if needed during the intervention. Immediately after the intervention, the participant will fill the post-operative anxiety and pain questionnaire. The participant will be instructed to report anxiety and pain felt during the intervention.
~A clinical visit at 3 month is conducted as part of the standard clinical protocol. The participant will fill a 3rd questionnaire about the remembered anxiety and pain during the intervention."
15786393|NCT04561583|Device|LED light source system for endoscope|"This trial is designed as a prospective, multi-center, single-blind, parallel, randomized controlled clinical trial. The trial will be carried out in 5 centers, involving 220 subjects as estimated who will be divided into the test group or control group randomly on an equal basis (each group includes 110 subjects).
~This trial will be carried out in 4 stages, including the screening period, random grouping, operation date and follow-up period. In the screening period, the informed consent forms are collected and inclusion and exclusion criteria are verified; after that, the accepted subjects will be randomly divided into the control group or test group; on the operation date, the operation is carried out using the device; safety follow-up visit is carried out during the follow-up period."
15786394|NCT04561583|Device|Pinpoint Endoscopic Fluorescence Imaging System|"This trial is designed as a prospective, multi-center, single-blind, parallel, randomized controlled clinical trial. The trial will be carried out in 5 centers, involving 220 subjects as estimated who will be divided into the test group or control group randomly on an equal basis (each group includes 110 subjects).
~This trial will be carried out in 4 stages, including the screening period, random grouping, operation date and follow-up period. In the screening period, the informed consent forms are collected and inclusion and exclusion criteria are verified; after that, the accepted subjects will be randomly divided into the control group or test group; on the operation date, the operation is carried out using the device; safety follow-up visit is carried out during the follow-up period."
15786395|NCT04561570|Device|Study Group|Subjects that were implanted with the Vivity ACRYSOF IQ extended depth of focus IntaOcular Lens
15786396|NCT04561570|Device|Control Group|Subject that were implanted with the ACRYSOF IQ Monofocal IntaOcular Lens
15786397|NCT04561557|Biological|CT103A cells|Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to manufacture CT103A cells, during which cyclophosphamide will be administered for the purpose of lymphocytes depletion. After lymphodepletion, subjects will receive one dose treatment with CT103A cells by intravenous (IV) infusion. The initial dose of 0.5×106 CAR+ T cells/kg will be infused on day 0.
15786398|NCT04561557|Drug|Cyclophosphamide and fludarabine|"Subjects will receive one 3-day cycle of lymphodepletion starting 4 days prior to CT103A infusion on Day 0.
~Subjects will be given IV infusion of cyclophosphamide 500 mg/m2/day on day -4, -3 and -2, and fludarabine 30 mg/m2 over 30 minutes administered immediately after cyclophosphamide."
15786399|NCT04561544|Behavioral|Knowing Who You Are (Becoming): Cultural Identity Intervention|8-week cultural identity development program led by Alaska Native Elders
15786400|NCT04561531|Other|3%NaCl|Intervention is infusion of 3%NaCl which is defined in arms of experiment.
15786401|NCT04561505|Procedure|Holmium laser enucleation of prostate|surgical management of BPH by Holmium laser enucleation using 0.9% saline fluid for irrigation
15786402|NCT04561505|Procedure|monopolar transurethral resection of prostate|surgical management of BPH by monopolar TURP using distilled water for irrigation
15786403|NCT04561492|Drug|[68Ga]Ga-PentixaFor|Tomography by emission of positons (PET) with theradiopharmaceutic [68Ga]Ga-PentixaFor
15786404|NCT04561479|Other|Pulmonary Rehabilitation|All exercise program will be applied during supervised session by a physiotherapist. Range of maximal heart rate will be screened by heart rate monitor during supervised session. Training group will receive upper extremity aerobic exercise training using arm ergometer at 60-80% of maximal heart rate (dyspnea perception at 3-4 level as well as fatigue perception at 5-6 level according to Modified Borg Scale). Inspiratory muscle training (Powerbreathe® Wellness-Inspiratory Muscle Trainer) at 50-60% of maximal inspiratory pressure (MIP) and progressive resistance training at 30-60% of 1 RM (using proprioceptive neuromuscular facilitation techniques (flexion, abduction, external rotation/extension, adduction, internal rotation) for upper extremity resistance training; using sandback for knee extensors) will be performed during 24 sessions (3 day/week; 8 weeks)
15786405|NCT04561479|Other|Alternative Exercises|Control group will receive alternative upper extremity exercises combined with breathing exercises. Control group will perform alternative upper extremity exercises combined with breathing exercises during 3 days/week, for 8 weeks
15786406|NCT04561466|Drug|Béfizal|600 mf befizal a day for one year
15786407|NCT04561453|Diagnostic Test|Multi-Platform Profiling with Organoid Drug Sensitivity Screening and ctDNA Monitoring|All patients in the study will have organoid creation and organoid drug sensitivity screening attempted on their fresh tumor tissue from surgical resection. All patients will also have blood taken pre-operatively and at multiple post-operative time points to monitor circulating tumor DNA.
15786408|NCT04561440|Diagnostic Test|molecular karyotyping|performed by NGS or CMA chip
15786409|NCT04561427|Other|Study of Sleep architecture in children with narcolepsy|Evaluate the cognitive performances, the effects of narcolepsy treatments on sleep architecture and the metabolic status of these children
15786491|NCT04560816|Drug|Placebo|Placebo will be administered orally.
15786410|NCT04561414|Device|LED light source system for endoscope|The prospective, multi-center, single-blind, parallel, randomized controlled superiority trial design is adopted to evaluate the safety and effectiveness of the LED light source system for endoscope during ureter transillumination. The trial will be carried out in 5 centers, with the competitive grouping mode adopted. This trial will be carried out in the General Surgery Department and the Gynecology Department. Totally 120 subjects with rectal cancer, endometriosis, cervical cancer, adenomyosis and pelvic adhesion requiring operation (60 subjects for each of the test group and control group) are involved. The test group use LED light source system for endoscope.
15786411|NCT04561414|Device|Ureteral stent (Cook Ireland Ltd.)|The prospective, multi-center, single-blind, parallel, randomized controlled superiority trial design is adopted to evaluate the safety and effectiveness of the LED light source system for endoscope during ureter transillumination. The trial will be carried out in 5 centers, with the competitive grouping mode adopted. This trial will be carried out in the General Surgery Department and the Gynecology Department. Totally 120 subjects with rectal cancer, endometriosis, cervical cancer, adenomyosis and pelvic adhesion requiring operation (60 subjects for each of the test group and control group) are involved. The test group use Ureteral stent (Cook Ireland Ltd.).
15786412|NCT04561401|Device|Repeated Transcranial Magnetic Stimulation (rTMS)|rTMS will be applied at 10 Hz. Each train will consist of 40 supra threshold (120% resting motor threshold) pulses over 4 seconds with an inter-train interval of 26 seconds. Treatment sessions will last 37.5 minutes (75 trains/3,000 pulses), and occur at the same time of day on every weekday for a period of three weeks (15 days total). During TMS, only passive activities will be allowed (i.e., watching movies or TV, listening to music). Three weeks of treatment was selected based on existing rTMS evidence in youth with treatment resistant major depressive disorder.
15786413|NCT04561401|Other|Intensive Pain Rehabilitation Program (IPRP)|The paediatric Intensive Pain Rehabilitation Program (IPRP) in Canada was established to target youth with severe chronic pain and consequent functional disability who do not respond to standard outpatient pain therapies. The IPRP at the Alberta Children's Hospital (ACH) involves three- to six-weeks of day-treatment rehabilitation, provided by an interdisciplinary team (e.g. Psychology, Physiotherapy, Family Therapy). This rehabilitative program teaches self-management strategies with the goal of helping youth and their families resume normal daily functioning.
15786417|NCT04561375|Drug|Sufentanil|30 µg tablet of sublingual sufentanil
15786418|NCT04561375|Drug|Fentanyl|50 µg fentanyl
15786419|NCT04561362|Drug|BT8009|Participants will receive a 60-minute IV infusion of BT8009 once weekly (i.e., on Days 1, 8, and 15, and 22) on a 28-day cycle.
15786420|NCT04561362|Drug|Nivolumab|Nivolumab will be a 240 mg dose every 2 weeks administered as per local labeling as a 30 minute intravenous infusion (window of -5 to +15 minutes).
15786421|NCT04561349|Other|Task oriented training|Task oriented training consisted of different functional tasks for lower limbs to improve balance and walk. Each task was given 5 minutes Tasks were progressed according to each child's performance. These progressions included increase of repetitions, speed and switching between the tasks. One hour practice of these tasks was advised for home plan
15786422|NCT04561349|Other|Conventional rehabilitation treatment|"Conventional rehabilitation treatment includes mat activities and ROM of all limbs, Lower limb strengthening and stretching, walking, cycling.
~Each exercise was performed for 5 minutes. One hour practice of above exercises and thermotherapy for the spastic muscles advised for 10 minutes once a day at home was advised."
15786423|NCT04561336|Drug|Avelumab|avelumab in combination with cetuximab
15786424|NCT04561336|Drug|Cetuximab|avelumab in combination with cetuximab
15786425|NCT04561323|Diagnostic Test|Dual-energy CT|"Patients suspected of acute bowel ischemia will be scanned in the dual-energy CT scanner.
~The abdominal imaging protocols are predetermined by the Department of Diagnostic Radiology, Righospitalet, Denmark."
15786426|NCT04561310|Other|Post facilitation stretch|"Post facilitation stretch with maitland mobilization Grade I & II Maitland mobilization of shoulder joint in 1st and 2nd week progressing to Grade III oscillatory mobilization of shoulder joint in 3rd week. It will further progress to Grade IV Maitland oscillatory mobilizations in the 4th or 5th week.
~Treatment will be provided 3 session/week for 6 weeks with 40 minutes/session"
15786427|NCT04561310|Other|Active release technique|"Active release technique with maitland mobilization Grade I & II Maitland mobilization of shoulder joint in 1st and 2nd week progressing to Grade III oscillatory mobilization of shoulder joint in 3rd week. It will further progress to Grade IV Maitland oscillatory mobilizations in the 4th or 5th week.
~Treatment will be provided 3 session/week for 6 weeks with 40 minutes/session"
15786428|NCT04561297|Diagnostic Test|TDC differential value|TDC measurements in all patients agreeing to participate who are scheduled for a biopsy of a breast tumor or mass
15786429|NCT04561284|Dietary Supplement|Indigestible fiber (classified)|Participants will be asked to ingest 12 grams of indigestible fiber powder per day for a period of 8 weeks. Three times daily, they will take 4 grams of powder with their meal.
15786430|NCT04561284|Dietary Supplement|Placebo|Participants will be asked to ingest 6 grams of placebo powder per day for a period of 8 weeks. Three times daily, they will take 2 grams of powder with their meal.
15786492|NCT04560816|Drug|Moxifloxacin|Moxifloxacin (400 milligrams) will be administered orally.
15786432|NCT04561271|Other|toucher massage|one session of toucher massage with a nurse (this technique is taught during the formation of every nurse in palliative care units). The session lasts 15 to 20 minutes, patients seated, half seated or in supine position. It consists in a simple massage and effleurage, with fluid and progressive movements. Almond oil will be used. The session is accompanied by relaxing music.
15786433|NCT04561258|Biological|AGT103-T|An autologous, genetically modified PBMC product enriched with HIV-specific and resistant CD4 T cells
15786434|NCT04561245|Drug|ALT-801|Injected subcutaneously (SC)
15786435|NCT04561245|Other|Placebo|Injected subcutaneously (SC)
15786436|NCT04561232|Behavioral|Prone and Upright Locomotor Training|"During the movement observation phase, infants will wear a wireless movement sensor at each ankle for two days. Research staff will show the caregivers how to place the sensors in the morning and charge them overnight.
~The training protocol for the prone training will consist of: 1) Warm-up. 2) Assisted movement of the arms and legs. 3) Calibration of the infant's arm and leg positions. 4) Self-initiated mobility for up to five minutes.
~For upright training, the environment will be arranged to encourage active motor exploration and variability in walking activities.The therapist will assist the child as needed to encourage upright locomotor activities, but only the minimum amount needed to perform the task. Weight assistance will be gradually reduced as postural control and coordination improve."
15786437|NCT04561219|Drug|Nitazoxanide|Nitazoxanide 500mg three times a day for 5 days
15786438|NCT04561219|Drug|Placebo|Placebo three times a day for 5 days
15786439|NCT04561206|Drug|Brentuximab Vedotin|Given IV
15786440|NCT04561206|Biological|Nivolumab|Given IV
15786441|NCT04561193|Other|Observational|Observational
15786442|NCT04561180|Drug|EG-009A|Administered as an Intramuscular injection
15786443|NCT04561180|Drug|EG-009A Placebo|Administered as an Intramuscular injection
15786444|NCT04561180|Drug|Standard of Care|Standard of Care Treatment for COVID-19 Infection
15786445|NCT04561180|Drug|Dexamethasone|The comparator, Administered as an Intravenous infusion
15786446|NCT04561167|Other|Cuspal reduction in MOD cavity in endodontically treated teeth|Not only the quality of endodontic treatment that affects the prognosis of the endodontically treated tooth, but the subsequent restorative treatment as well. Coverage, Endocrowns, Onlays, Inlays Restorations on Fracture Resistance of Endodontically Treated Molars, it was found that the worst results came to the inlay restorations and this was attributed to geometric form of preparation that exert a wedging force acting to split the tooth when under occlual stress however, onlay and full coverage direct the force along the long axis by overlaying the cusp tips and a portion of buccal and lingual surface thus opposing the wedging action created by internal design of restoration (Magne P and Belser C. et al 2003) That's why, choosing such a design as a comparator to the design of the cuspal reduction and further coverage (onlay) is crucial to show the importance of cuspal coverage for the indirect resin composite restoration in the endodontically treated teeth.
15786447|NCT04561167|Other|No cuspal reduction in MOD cavity in endodontically treated teeth|In an invitro study done by (Ahmed Hamdy 2015) investigating the effect of Full The amount of lost internal tooth structure as well as the coronal hard tissue in an endodontically treated tooth is considered the main factors that make the tooth susceptible to biomechanical failure when compared to a vital tooth. (Guo J et al 2016) .
15786448|NCT04561154|Other|questionnaire|three months after hospitalization, a questionnaire will be sent to patients. If necessary, patient will be seen in consultation of geriatry, otorhinolaryngology, pneumology, neuropsychology
15786449|NCT04561128|Drug|SHR-1819|SHR-1819 will be subcutaneously administered with different dose levels
15786450|NCT04561128|Drug|Placebo|Placebo will be subcutaneously administered with different dose levels
15786451|NCT04561115|Biological|Gamunex-C|Intravenous infusion.
15786452|NCT04561115|Biological|IVIG-PEG|Intravenous infusion.
15786453|NCT04561102|Diagnostic Test|Diagnostic test for detection of SARS-CoV-2|The COVIDSeq is designed to test RNA extracted from NP swab specimens from patients symptomatic for COVID-19
15786454|NCT04561089|Diagnostic Test|COVIDSeq Test|The COVIDSeq is designed to test RNA extracted from NP swab specimens from patients symptomatic for COVID-19
15786455|NCT04561076|Drug|HLX70|Single-dose, intravenous infusion
15786456|NCT04561076|Other|Placebo|Single-dose, intravenous infusion
15786457|NCT04561063|Drug|Nitazoxanide|Nitozoxanide 1 tablet (500 mg) taken 12-hourly with food for the first week, followed by 2 tablets (1000 mg) taken 12-hourly with food thereafter. (Participants that fail to tolerated the 1000 mg 12-hourly dose may revert back to the lower dose.)
15786458|NCT04561063|Drug|Sofosbuvir/Daclatasvir|Sofosbuvir/daclatasvir 400mg/60 mg sofosbuvir/daclatasvir fixed dose combination 1 tablet daily
15786459|NCT04561050|Other|Comparison of score performances (Overall performance, discrimination and calibration)|"Our Study is an observational non-interventional study based on a multicentric anonymized registry. It's an external validation of pre-existing prognostic scores of traumatic haemorrhages at different times of care (Scene of Injury, admission at the trauma room) in order to assess their overall performance, discrimination and calibration in the prediction of massive transfusion and haemorrhagic death.
~The statistic intervention will be a comparison of score performances (Overall performance, discrimination and calibration)."
15786460|NCT04561037|Device|Pulsed Electromagnetic Field therapy (PEMFT)|PEMFT was connected to electrical mains supplying 220v. Pair of applicators sized 16x10x3 cm was adjust to be over TMJ, on both sides of the face; the appliance was adjusted to the frequency of 50 HZ and intensity of 90 Gauss. Twelve PEMF treatment sessions of 30 min duration were provided 3 times per week TMJ mobilization techniques and isometric exercises against resistance for muscles of mastication
15786461|NCT04561037|Other|TMJ physical therapy program|TMJ manual physical therapy program (mobilization and gentle isometric exercises) for 30, 3 times a week, for 4 weeks.
15786462|NCT04561024|Diagnostic Test|AI model|Deep Learning CNN model
15786493|NCT04560803|Device|CelluTomeTM Epidermal Harvesting System|Autologous epidermal grafts that will be placed at the treatment site
15786494|NCT04560790|Drug|BD111 Adult single group Dose|6 Participants will receive a single group dose administered via corneal injection in the study eye.
15786525|NCT04560569|Drug|3BNC117 Antibody|Recombinant, fully human mAb of the IgG1κ isotype that specifically binds to HIV-1 gp120
15786588|NCT04559958|Diagnostic Test|tongue image|capture tongue images by Automatic Tongue Diagnosis System
15786463|NCT04561011|Behavioral|Internet-delivered Cognitive Behavioural Therapy(ICBT)|ICBT provides online structured self-help modules over several months based on the principles of CBT in combination with weekly guidance through emails and telephone calls. The course comprises 6 online lessons that provide psychoeducation about: 1) symptom identification and the cognitive behavioural model; 2) thought monitoring and challenging; 3) de-arousal strategies and pleasant activity scheduling; 4) graduated exposure/pacing; 5) memory and attention; and 6) relapse prevention. Participants will also have the opportunity to ask any questions regarding the content of the program materials and will receive a response from their Guide within 48-72 hours. Guide will spend ~15 mins. per week/per participant. All Guides have completed a university program (psychology or social work) and are registered clinicians or students working under supervision of a registered clinician.
15786466|NCT04560985|Other|Hydrophilic fissure sealant|Hydrophilic fissure sealant on first molars
15786467|NCT04560985|Other|Hydrophobic fissure sealant|Hydrophobic fissure sealant on first molars
15786468|NCT04560972|Drug|Atezolizumab|Given IV
15786469|NCT04560972|Drug|Carboplatin|Given IV
15786470|NCT04560972|Drug|Etoposide|Given IV
15786471|NCT04560972|Drug|Protein Phosphatase 2A Inhibitor LB-100|Given IV
15786472|NCT04560959|Device|tACS|tACS would be performed to epilepsy patients who have already received implantation of the SEEG electrodes
15786473|NCT04560946|Behavioral|Personalized Augmented Cognitive Training (PACT)|Personalized Augmented Cognitive Training (PACT) group. Intervention: Behavioral: The study neuropsychologist will use a portion of the TBI education session to describe available treatment modules and make recommendations for module selection based on results from baseline assessment. After discussion, five 60-minute CogSMART modules will be selected. PACT participants will receive guidance to complete 2 modules per week of the CogSMART app. PACT participants will also receive guidance to complete BrainHQ exercises of their choice for 30 minutes a day, 5 days per week, for a total training time of 15 hours.
15786474|NCT04560946|Behavioral|Enhanced Treatment As Usual|"Enhanced Treatment As Usual (ETAU) group. Intervention: Behavioral: The ETAU condition was designed to replicate treatment as usual following neuropsychological assessment of post-TBI cognitive problems. Treatment as usual for mTBI patients at the VA hospital usually consists of: 1) A general evaluation by the polytrauma clinic, 2) Possible neuropsychological assessment evaluation by the TBI Cognitive Rehabilitation Clinic, and 3) If impairments are present, cognitive rehabilitation is offered. The current study's condition is considered enhanced treatment as usual because standard of care for chronic mTBI does not always involve neuropsychological assessment with feedback and psychoeducation or the provision of self-directed tools such as the CogSMART app or BrainHQ cognitive training software."
15786475|NCT04560933|Procedure|Blood sample collection|Blood sample collection
15786476|NCT04560920|Other|Availability of contextual PGD at the visit|Contextual PGD will be availability in a display at the visit.
15786477|NCT04560907|Procedure|Aquablation|"By means of a high-pressure saline stream, parenchymal tissue of the prostate is removed endoscopically through a heat-free mechanism called hydrodissection. The intervention is supported by live ultrasound guidance and the required depth as well as the angle of the resection is planned out prior to the resection. The bladder is accessed using a 24-Fr hand-piece, which accommodates the scope. The handpiece is supported by an articulating arm attached to the operation table. Once placed in the optimal position, the system automatically adjusts the alignment as necessary.
~Hemostasis is consecutively achieved through diathermy and post procedure, a threeway catheter is inserted and bladder irrigation is initiated."
15786478|NCT04560907|Procedure|HoLEP|This is done endoscopically under general anesthesia the three lobes of the prostate that are cored out intact with the laser are pushed into the bladder before being morcellated by a special instrument inserted through the telescopic camera. A catheter is placed into the bladder to drain the urine while the raw surface heals, then left in place for around 24 hours before being removed on the day of discharge from hospital. Sterile saline fluid is also irrigated into the bladder through the catheter to dilute any blood in the urine and prevent clots from forming.
15786479|NCT04560894|Drug|SCT-I10A|Participants receive SCT-I10A intravenously，200mg，d1，Q3w
15786480|NCT04560894|Drug|SCT510|Participants receive SCT510 intravenously，15mg/kg，d1，Q3w
15786481|NCT04560894|Drug|Sorafenib 200mg|Participants receive sorafenib orally，400mg bid
15786482|NCT04560881|Biological|Inactivated SARS-CoV-2 vaccine (Vero cell)|Immunization schedule: 2-doses of investigational vaccine or placebo are inoculated to the deltoid muscle of the upper arm according to the immunization schedule of Day 0, 21.
15786483|NCT04560881|Biological|Placebo/Aluminum Adjuvant of Inactivated SARS-CoV-2 vaccine|Immunization schedule: 2-doses of investigational vaccine or placebo are inoculated to the deltoid muscle of the upper arm according to the immunization schedule of Day 0, 21.
15786484|NCT04560868|Device|Control mHealth program|The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence.
15786485|NCT04560868|Device|Experimental mHealth program|The intervention includes a mHealth intervention that is grounded in best practice recommendations for treatment of nicotine dependence. Experimental participants also receive additional content designed to motivate smoking reduction/quitting and provide skills training.
15786486|NCT04560868|Drug|Nicotine patch|Participants in both arms can earn the ability to request a 2-week supply of over-the-counter nicotine patches. Patches are earned through accumulated use of the assigned mHealth program.
15786487|NCT04560855|Device|Connected devices measurements|The patient has to measure everyday several vital parameters like respiration and heart rate during the night with Withings Sleep, temperature with Withings Thermo, arterial pressure with Withings Tensiometer and physical activity with Withings smartwatch.
15786488|NCT04560842|Device|A high flow oxygen device.|The HFNC group use high flow oxygen device for 48 hours
15786489|NCT04560842|Device|Conventional oxygen therapy|Conventional oxygen device
15786490|NCT04560816|Drug|ALXN1840|ALXN1840 (120 milligrams) will be administered orally (supratherapeutic dose).
15786495|NCT04560777|Other|CO-OP intervention|"The general structure of the intervention will follow the original key principles of CO-OP, with some adjustments to adapt it to the specificities of the ABI population (14 CO-OP sessions vs 10 in the original protocol).
~The global strategy will be taught to the participant at the first session. The following sessions will be consisted of an process of implementation of the global strategy in the context of guided discovery to identify domain specific strategies to overcome performance ''breakdowns the participant will be experiencing when performing the self-selected tasks. In addition, homework will be assigned to encourage the application and practice of the cognitive strategies discovered during the intervention sessions. Parents will be invited to attend the sessions if it will be possible for them. In any case, the global strategy, as well as the progress of the child, will be explained to the parents."
15786496|NCT04560764|Device|Virtual Reality|"Participants in both groups will attend 10 sessions of approximately 30 minutes each three times a week. Each session contemplates the execution of a single repetition of two minutes of each of the four exercises.
~There are four exercises:
~Reaching: the participant is requested to reach a target in front of him with the paretic hand; the target will appear in a different place every time;
~Reaching and grasping: the participant is requested to grab a wooden cube with the paretic hand and place it into a bowl positioned in front of him; the cube will appear in a different place every time;
~Goalkeeper: the participant is requested to block a ball coming towards him with the paretic hand; the ball will appear in a different place every time;
~Occupational task: the participant is requested to grab four cans, one at time, with the paretic hand and place them on four targets placed on a hemispherical arch.
~Each exercise provides six levels of increasing difficulty."
15786497|NCT04560764|Device|Action Observation Therapy|"Before the execution of the exercises described in the intervention Virtual Reality, the participants in the experimental group will see a video demonstrating the same exercise (according to the level of difficulty selected) he will be later asked to perform for two minutes."
15786498|NCT04560764|Device|Landscape video|"Before the execution of the exercises described in the intervention Virtual Reality, the participants in the sham comparator group will see a video of a natural landscape for two minutes."
15786499|NCT04560764|Other|Standard treatment|Participants in both groups will receive the standard treatment, one hour a day for three days a week.
15786500|NCT04560751|Drug|Lenvatinib|Lenvatinib capsules will be administered orally, once daily (for patients <60kg, lenvatinib 8mg po; for patients ≥60kg, lenvatinib 12mg po)
15786501|NCT04560751|Procedure|TACE|TACE will be performed as needed.
15786502|NCT04560738|Drug|[14C]-CC-92480|Oral
15786503|NCT04560725|Drug|11C-Choline|11C-choline (0.05-0.1mCi/kg) was injected intravenously one week before or after the [68Ga]P137 PET/CT examination, and imaging of the head and body cadres was performed 20 min after the injection using Philips Gemini TF16 or Siemens Biograph M-CT flow PET/CT
15786504|NCT04560712|Procedure|Acupuncture Therapy|Undergo acupuncture
15786505|NCT04560712|Other|Best Practice|Undergo usual care
15786506|NCT04560712|Other|Questionnaire Administration|Ancillary studies
15786507|NCT04560699|Other|Physiotherapeutic treatment and medical care|Physiotherapeutic treatment twice a week for twelve weeks and medical care three times at baseline, week 13 and week 26
15786508|NCT04560699|Other|medical care|medical care three times during the study period; baseline, week 13 and week 26
15786509|NCT04560686|Drug|Bintrafusp Alfa|Given IV
15786510|NCT04560686|Procedure|Therapeutic Conventional Surgery|Undergo surgery
15786511|NCT04560673|Drug|Duloxetine|Given PO
15786512|NCT04560673|Behavioral|Neurofeedback|Receive neurofeedback training
15786513|NCT04560673|Other|Quality-of-Life Assessment|Ancillary studies
15786514|NCT04560673|Other|Questionnaire Administration|Ancillary studies
15786515|NCT04560660|Drug|Ketamine|FDA approved anesthetic medication with rapid acting antidepressant effects.
15786516|NCT04560660|Drug|Midazolam|FDA approved sedative medication with dissociative effects.
15786517|NCT04560647|Other|No intervention - Psoriasis Subject|Not currently treated plaque psoriasis patients
15786518|NCT04560647|Other|No intervention - Control Subject|Control subjects without plaque psoriasis and no family history of psoriasis
15786519|NCT04560634|Drug|Norepinephrine|Norepinephrine is administered as a continuous infusion at 0.05 mcg/kg/min and is kept to maintain systolic blood pressure within 90-120% of baseline during spinal anaesthesia. The infusion is started at the same time cerebrospinal fluid is obtained, immediately before injection of spinal medications, through a small-bore tubing connected directly to the peripheral intravenous catheter. It is stopped 5 minutes
15786520|NCT04560634|Device|ClearSight®, Edwards Lifescience, Irvine, CA|"All patients are connected to a ClearSight® monitor (ClearSight®, Edwards Lifescience, Irvine, CA) by an inflatable finger cuff placed on the midphalanx of hand middle or ring finger with no radial artery catheter and its heart reference system (HRS) is zeroed at the level of the patient's midaxillary line.
~The ClearSight® monitoring is started in the pre-anaesthesia room and calibrated for 5 minutes before recording. The monitoring continues throughout the procedure until patient transfer in the recovery room. All data are anonymously collected on a USB pen for statistical analysis."
15786521|NCT04560621|Behavioral|Managed Problem Solving (MAPS)|MAPS is an individual-level, problem-solving intervention delivered in person and via telephone calls to HIV clinic patients. The intervention focuses on improving medication adherence through an iterative, five-step process which consists of 1) identifying barriers to adherence, 2) brainstorming to generate potential solutions, 3) decision-making and developing a plan of action, 4) implementing the plan, and 5) evaluating and modifying the plan as necessary. In-person sessions include education related to the treatment regimen and to common medication misperceptions; problem-solving to identify daily routines, cues, cognitive aids and social supports; screening to identify barriers related to depression, substance use, toxicity management and competing demands; and review of adherence data to determine where problems have occurred and to develop solutions.
15786523|NCT04560582|Procedure|Blood Draw|Participants will have blood drawn for analysis at baseline and every 4 weeks for a total of 7 blood draws over 24 weeks.
15786524|NCT04560569|Drug|Albuvirtide|Long-Acting HIV-1 Fusion Inhibitor (chemically modified peptide targeting HIV-1 gp41)
15786526|NCT04560556|Diagnostic Test|Point-of-Care (POC) Rapid HIV Test|Point-of-care (POC) rapid HIV testing provides results within minutes, however, it cannot reliably detect new infections. It can take up to 90 days after exposure for HIV infections to be diagnosed with POC rapid testing.
15786527|NCT04560556|Diagnostic Test|Fourth Generation Antigen/antibody (Ag/Ab) HIV Test|Fourth generation laboratory-based antigen/antibody (Ag/Ab) HIV testing can detect acute HIV infections (as early as 18 days after exposure), but it takes several hours to process.
15786528|NCT04560543|Procedure|McCall suture|Additional suture after McCall in vaginal cuff closure after laparoscopic hysterectomies
15786529|NCT04560530|Radiation|Non-enhanced CT scan of the chest|Non-enhanced CT scan of the chest with multi-slice CT scan machine.
15786532|NCT04560491|Diagnostic Test|Intraoperative examination of sentinel node|Intraoperative examination of sentinel node by either frozen section or scrape cytology to detect metastasis and decide for further lymphadenectomy.
15786533|NCT04560478|Device|Pro Seal Sealant|Sealant was reapplied every 3 months
15786534|NCT04560478|Device|MI Varnish|Fluoride varnish was applied every 4-6 weeks
15786535|NCT04560465|Drug|Tranexamic acid|intravenous perioperative tranexamic acid was added into infusion of normal saline for the cases while placebo of intravenous water for injection was added into normal saline perioperatively for control
15786536|NCT04560439|Dietary Supplement|Dietary Intervention|Undergo METFIT program
15786537|NCT04560426|Device|Intraoperative parathyroid gland auxiliary recognition system|The enrolled patients are grouped according to whether or not to use the intraoperative parathyroid auxiliary recognition system.
15786538|NCT04560400|Diagnostic Test|Conventional King-Devick test|Conventional King-Devick test involves a series of number reading task from left to right and top to bottom, intending to test subjects' neuro-ophthalmologic function
15786539|NCT04560400|Diagnostic Test|Reverse King-Devick test|Reverse King-Devick test involves a series of number reading task from right to left and bottom to top, intending to test subjects' neuro-ophthalmologic function
15786540|NCT04560387|Behavioral|Physician-lead complex program of weight-reducing interventions|A structured motivational and goal directed program will be used for weight reduction involving physicians, nutritionists, educators and physiotherapists. Initially, based on the input data provided by the patient an individual nutritional plan will be designed with the aim of reducing caloric intake by 10%. Low-intensity aerobic exercise for 30 min will be prescribed 3-times a week with the aim of increasing the frequency to 5-times a week and participants will be offered the possibility to participate in regular physiotherapist-lead group exercises. Patients will be required to maintain a diet and physical activity diary. Regular reviews will be scheduled every 3-6 months according to the actual weight loss.
15786541|NCT04560387|Procedure|Bariatric surgery - sleeve gastrectomy|Bariatric surgery will be performed based on actual medical indication and independently of patient's participation in the study. Sleeve gastrectomy was selected as the currently most frequent restrictive type of bariatric surgery with a proven efficacy on weight reduction, metabolic status and low-grade inflammation
15786542|NCT04560374|Device|crochet octopus|Delivering crochet octopus to the hands of the neonates
15786543|NCT04560361|Other|Electroacupuncture treatment|Continue the electroacupuncture treatment as described above for 30 minutes.
15786544|NCT04560361|Other|Sham electroacupuncture treatment|Continue the sham electroacupuncture treatment as described above for 30 minutes.
15786545|NCT04560348|Other|adventure-based cognitive behavioral intervention|The adventure-based cognitive behavioral intervention is a combination of cognitive behavioral therapy and adventure training. The intervention program is delivered in a 39-hour general education course in a public university in Hong Kong. The program includes 6 lectures, 5 workshops, 5 adventure games and an adventure day camp. Students are divided into two groups in workshop to practise CBT skills to deal with their own issues.
15786546|NCT04560335|Behavioral|Coach to FIt|"CoachToFit: Those randomized to CoachToFit will have the CoachToFit app downloaded to their phone by the peer coach and will work with the coach to initialize the app. Individuals will receive an activity tracker compatible with Android OS and iOS (Amazfit Bit) and a Bluetooth scale (Smart Body scale). Participants will be instructed by the peer to complete at least two CoachToFit modules per week. Modules take about
~15 minutes to complete and have embedded knowledge quizzes and end with a choice of three goals to practice over the next week. They will also set up a time for the first 20-minute coaching call, which will then continue weekly."
15786547|NCT04560335|Behavioral|Treatment as Usual|Veterans randomized to the treatment as usual arm will continue to access all services of the VA Pittsburgh, and will participate in three research interviews. After the first meeting, all participants will meet with a peer coach (peer specialists) who will discuss with them the importance of losing weight (using a structured conversation that follows a handout which is provided to the participant). The handout was developed with input from a VA dietitian as well as Veterans and is graphically appealing, with a simple layout, and provides information on diet and activity as well as the local MOVE! schedule
15786548|NCT04560322|Drug|Venetoclax|Tablet, taken by mouth
15786549|NCT04560322|Drug|Obinutuzumab|Intravenous infusion
15786550|NCT04560322|Drug|Acalabrutinib|Capsule, taken by mouth
15786551|NCT04560309|Drug|L-alanyl-L-glutamine dipeptide|Intravenous infusion of 0.5 mg/kgbw L-alanyl-L-glutamine dipeptide diluted in normal saline to volume of 500 mL, started after induction of anesthesia for 24 hours.
15786552|NCT04560309|Drug|Placebo|Intravenous infusion of 500 mL normal saline, started after induction of anesthesia for 24 hours.
15786553|NCT04560296|Behavioral|Nurse-led e-Health program|Nurse-led e-Health program will be developed to engage and empower older adults to manage the chronic conditions effectively.
15786554|NCT04560296|Behavioral|usual self-management and follow up with doctors/nurse|usual self-management and follow up with doctors/nurse as planned in the community nurse post.
15786555|NCT04560283|Drug|Vaginal gel HYALOGYN®|Vaginal gel HYALOGYN® (HYDEAL-D® 2%; Fidia Farmaceutici, Abano Terme, Italy) every 3 days up for 12 consecutive weeks
15786556|NCT04560283|Behavioral|Expectant management|Expectant management for 12 consecutive weeks
15786557|NCT04560270|Diagnostic Test|Blood samples|Blood samples to determine ctDNA levels during chemotherapy
15786586|NCT04559971|Drug|SLN124|SLN124 for subcutaneous (s.c.) injection
15786558|NCT04560257|Device|High flow nasal cannula HFNC|High flow nasal cannula HFNC is a device that delivered the warmed and humid air on high flow rate through nose. It is used to treat severe respiratory distress in COVID-19 patients, a non-invasive ventilatory approach which is relative comfortable by using humidified and pre-heated air containing large concentration of oxygen.
15786559|NCT04560244|Drug|SHR1701|PD-L1 / TGF-β RII double antibody
15786560|NCT04560231|Drug|Remdesivir|200 mg I/v Remdesivir will be given to moderate disease patients of COVID-19. It will be loading dose then 100 mg I/V dose will be given for 5 days. Customized decision for Remdesivir dosage will be made by attending infectious diseases physician, comfort with usage, bacterial co-infection and duration of Ventilation and dose will be extended up to 10 days according to clinical condition of the patients.
15786561|NCT04560218|Drug|sublingual Misoprostol|apply drug by Anesthesiologist
15786562|NCT04560218|Drug|Intrauterine Misoprostol|apply drug by surgeon at uterine cornu
15786563|NCT04560205|Drug|Tocilizumab|"4-8mg/kg with 400mg maximum dose of Tocilizumab will be given in 60 minutes I/V infusion, and dose will be repeated after 12-24 hours according to clinical as well as laboratory parameters.
~Customized decision for Tocilizumab usage will be made by attending infectious diseases physician, comfort with Tocilizumab usage, bacterial co-infection and duration of Ventilation."
15786564|NCT04560192|Behavioral|Mindfulness based Emotion regulation therapy (MBERT) - Treatment as usual (TAU)|"In each of 8 sessions (allocated over 4 weeks) the patient brings an (actual) topic that induces rumination. After identifying the underlying affect, the patients are instructed (1) to concentrate on it, (2) to accept and tolerate it (considering the personal situation and experiences), (3) to give it a new interpretation so the patient can look at it with a more generous view, and (4) to dissociate from it, so the patient can perceive it as one of many affects and as one that hasn't the power to influence one's thoughts and actions that much (as it does through rumination). These steps are gradually instructed and trained throughout 20 trials (à 40 seconds) in each session. After each trial there is room to talk about the trial, possible barriers and helpful strategies to overcome those. Between-sessions the patients are encouraged to train the strategies in their daily life and do some homework like a protocol of ruminative thoughts and meditation.
~Waiting period with TAU."
15786565|NCT04560192|Other|Treatment as usual (TAU) - Mindfulness based Emotion regulation therapy (MBERT)|"Waiting period with TAU.
~In each of 8 sessions (allocated over 4 weeks) the patient brings an (actual) topic that induces rumination. After identifying the underlying affect, the patients are instructed (1) to concentrate on it, (2) to accept and tolerate it (considering the personal situation and experiences), (3) to give it a new interpretation so the patient can look at it with a more generous view, and (4) to dissociate from it, so the patient can perceive it as one of many affects and as one that hasn't the power to influence one's thoughts and actions that much (as it does through rumination). These steps are gradually instructed and trained throughout 20 trials (à 40 seconds) in each session. After each trial there is room to talk about the trial, possible barriers and helpful strategies to overcome those. Between-sessions the patients are encouraged to train the strategies in their daily life and do some homework like a protocol of ruminative thoughts and meditation."
15786566|NCT04560179|Drug|Tobramycin solution for inhalation|This trial will investigate up to 4 different doses of inhaled tobramycin: 78mg, 150mg, 216mg, and 300mg - each administered every 12 hours
15786568|NCT04560153|Other|karate kata|sessions of karate kata every week during 4 months
15786569|NCT04560140|Behavioral|Narrative and Skills-building Intervention|The intervention is grounded in Narrative Theory and Bandura's principles of Self-efficacy and Outcome Expectation. It will consist of eight individual sessions over six months delivered by a facilitator. Participants will be facilitated to narrate their survival experiences and rebuild core life skills.
15786570|NCT04560127|Drug|Camrelizumab combination with Apatinib|Apatinib (250mg p.o. q.d.) combined with Camrelizumab (200mg, iv, q2w)
15786571|NCT04560114|Drug|Essential oils|"The patient will be invited to inhale the essential oils via the stick:
~4 times a day before each meal and snack.
~if necessary when nausea appears, as many times as he deems necessary."
15786572|NCT04560101|Drug|botulinum toxin A|Intramuscolar injection of botulinum toxin in affected muscles
15786573|NCT04560088|Behavioral|Mindfulness|Mindfulness-based mobile health intervention.
15786574|NCT04560088|Behavioral|Breathing|Breathing mobile health intervention.
15786575|NCT04560075|Behavioral|Text2Connect|The T2C intervention aims to increase mental health self-efficacy though psychoeducation, self-monitoring of symptoms and stressors, and cues to action for college-bound youth.
15786576|NCT04560075|Behavioral|Psychoeducational Videos (PE) Only|Participants in this group will receive psychoeducation through the PE video library.
15786577|NCT04560062|Other|Spontaneous changes in diabetes-related health care|The findings of a retrospective cohort analysis conducted in the initial phase of the study will be used in focus groups to identify observed weaknesses in local health systems and will promote possible solutions to strengthen diabetes-related health care. Every focus group will include community members, healthcare workers, decision-makers and diabetic patients and family members.
15786578|NCT04560049|Drug|Silver Nitrate|application of silver nitrate to sinus tract
15786579|NCT04560049|Drug|Phenol|phenolisation of sinus tract
15786580|NCT04560036|Diagnostic Test|FAZA PET/MRI scan|FAZA PET/MRI scan before and after the standard of care chemotherapy
15786581|NCT04560023|Other|Exposition to multimedia content|Video and images watched on a tablet. Patient could decide which information want to watch.
15786582|NCT04560010|Drug|Tranexamic Acid Injection|Injection of 1 gram of IV TXA before surgical plus 1 gram of IV TXA three hours later
15786583|NCT04559997|Other|Exercise+FU|6 years intervention, administered daily, targeted postural instability, balance and mobility using at-limit intensity sensorimotor and visuomotor agility training
15786584|NCT04559997|Other|Active Comparator group Exercise|After 3 weeks of intensive therapy, we withdrew treatment and monitored their condition for 6 years and received only hospital base treatment
15786585|NCT04559984|Device|JUVÉDERM VOLUX®|JUVÉDERM VOLUX® injectable gel
15786589|NCT04559945|Device|Aveir Leadless Pacemaker System|Patients will undergo an attempted leadless pacemaker implant
15786590|NCT04559932|Other|Tracheostomy Training Course|A standardized competency-based education tracheostomy module has been developed by the investigator group in collaboration with Respiratory Medicine, Complex Care, Respiratory Therapy, Nursing Education, Family Advisory Network and the Learning Institute at SickKids. Instructional methods for the full module are based on principles of adult learning and evidence from the procedure education literature and include the use of interactive, small-group teaching, hands-on simulation-based learning stations with relevant equipment as well as a formal assessment of knowledge and skills using simulation. Pre-learning packages are sent to course attaendees at the time of registration to facilitate higher level discussions on the day of the course. While investigators have rigorously developed the curriculum and evaluation measures, the course outcomes remain unknown.
15786591|NCT04559919|Other|Seizure status|We will collect information on first seizure ever, last seizure ever, number of seizure in last two months.
15786592|NCT04559919|Diagnostic Test|Tests|We will collect results from imaging, electroencephalogram, and laboratory tests.
15786593|NCT04559919|Other|Epilepsy|We will collect information on risk factors of epilepsy, cause of epilepsy, epilepsy type/syndrome, medications tried, if the epilepsy is drug resistent, side effects of antiepileptic drugs.
15786594|NCT04559919|Other|Demographics and psychosocial|We will collect information on age, sex, date of death if applicable, marital status, education level, income type, driving status, employment, benefits, sick leave, number of household members.
15786595|NCT04559919|Other|Health care|We will collect information on received health care; visit dates, caregiver, dispensation dates of antiepileptic drugs
15786596|NCT04559906|Combination Product|Spray and Stretch technique (Ethyl chloride)|"Group A receive spray and stretch technique (Ethyl chloride) with conventional treatment.
~The upper trapezius muscle stretches on the basis of the Technique originally described by Simons. The subject is seated in a relaxed position on their homolateral hand for anchoring the distal end of the studied muscle. Initially, 3 to 5 parallel sweeps of ethyl chloride spray is applied covering the Upper trapezius muscle. Then, the muscle are positioned in a maximal but tolerable stretch and lengthened until the Physical Therapist felt the muscle tension barrier. This procedure repeated 2 or 3 times."
15786597|NCT04559906|Other|Sustain pressure release|"Group B receive sustain pressure release with conventional treatment. Progressive pressure release are considered in two stages. The initial step is to recognize and find the trigger in upper fiber of trapezius, utilizing trigger point palpation. Trigger point felt as firm and restricted hyperirritable knots with in gut of the muscle.
~The second step is to applying pressure release ranging from eight to twelve second for each pressure, then it increases gradually for maximum of twenty seconds. The total duration of pressure is five minutes or more until the discharge is felt by the fingers."
15786598|NCT04559893|Behavioral|Collaborative Care|Collaborative care consists of a team of providers that includes a care coordinator, a primary care provider (PCP) and a behavioral health consultant (BHC), who provide evidence- and measurement-based care to a panel of patients using a clinical registry. In our model, the CC team also includes a behavioral health psychotherapist (BHP) who consults on a regular basis but does not deliver direct care.
15786599|NCT04559880|Drug|Tranexamic Acid Injection [Cyklokapron]|Intra-procedurally, participants will receive 1 gram of intravenous tranexamic acid immediately following the polypectomy. Participants will also take oral tranexamic acid tablets (three times per day) at home for the five days following the procedure.
15786600|NCT04559867|Procedure|Needle knife fistulotomy|A needle knife fistulotomy uses a tiny knife to cut directly into the ampulla to gain access to the biliary system in patients undergoing ERCP.
15786601|NCT04559867|Procedure|Sphincterotomy|A sphincterotomy uses a heated metal wire to cut the opening to the bile duct after a wire has been passed into it.
15786602|NCT04559854|Behavioral|Mindful After Cancer|The intervention includes eight weekly sessions (1.5-2 hours each), plus participant educational materials and audio recorded meditations, and is delivered to women in their homes via group videoconference led by a trained facilitator. Participants are asked to complete activities and mindfulness practice between sessions.
15786603|NCT04559841|Other|bone substitute; NanoBone®|surgical treatment of peri-implantitis using a regenerative surgical protocol utilizing NanoBone (NB) synthetic bone graft with or without simvastatin.
15786604|NCT04559828|Other|Experimental meal|Two dietary oils will be administrated as part of a single experimental meal, for the present is a postprandial phase study.
15786605|NCT04559815|Drug|Oral Semaglutide|Patients will be treated with commercially available oral semaglutide according to local label and to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study.
15786606|NCT04559802|Procedure|Transmucosal Technique|Dental implant will be placed in transmucosal manner (Healing abutment is exposed in the mouth).
15786607|NCT04559802|Procedure|Submerged Technique|Dental implant will be installed in submerged manner (implant is completed covered by soft tissue).
15786608|NCT04559789|Behavioral|MindMate + Health Coaching|The MindMate app is a digital multi-domain lifestyle intervention designed to address modifiable risk factors for dementia. The app will be augmented with digital health coaching provided by Neurotrack.
15786609|NCT04559789|Other|Health Education|Health education materials delivered electronically
15786610|NCT04559776|Other|gait analysis|gait analysis with 3D optoelectronic system and surface EMG
15786611|NCT04559763|Device|Non-Invasive Controlled Hypoxia|Following arterial cannulation, hypoxia is induced by reducing the percent of inspired oxygen the subject breathes while simultaneous measurements are recorded from the test pulse oximeters and arterial blood samples are collected at targeted levels of saturation.
15786612|NCT04559763|Other|Introduction of Motion conditions: tapping or rubbing|Standard motions include tapping or rubbing at periodic intervals with amplitudes of 1-2 cm and 1-4 Hz with a random variation in frequency will occur at each plateau. Each plateau will have both an interval of tapping and rubbing. Signals are recorded by a validated, computerized data acquisition system (CAS). The device values are sampled once per second and averaged over the time taken to draw the blood sample, taking into account circulation time delays and differences in device response times
15786613|NCT04559750|Behavioral|Cognitive behavioral therapy|10 weeks of CBT delivered via the Internet.
15786614|NCT04559737|Other|Case Management|"Population management platforms capable of automatically risk stratifying patients (eg, automatically identifying poor users) may be another cost-effective technology-based tool by enabling a management by exception (MBE) follow-up intervention. This intervention concentrates provider effort on patients most at need by allowing providers to passively observe successful users and actively intervene only in CPAP strugglers. Therefore, in addition to Usual Care we will implement this population management process by identifying CPAP strugglers only and further follow-up encounters will be triggered for these select patients for troubleshooting. Additionally, throughout the 1-year period, Q1 window of <70% nights >4 hours will trigger a phone call and at the discretion of the sleep provider convert to video or in-person encounter for troubleshooting. CPAP Follow-Up Questionnaire will also be delivered to patient at 3 months and 1 year."
15786615|NCT04559724|Device|Indego Therapy|Indego Therapy consists of 15 + 2 sessions of Indego - Therapy, each lasting 30 minutes for a maximum of 6 weeks. All the device parameters such as step height (knee and hip), step length, step cycle speed, single and bilateral assistance are customizable. The use of aids during Idego-Therapy is allowed if needed. The Indego specialist should initially be positioned behind the patient, checking the exoskeleton and patient's gait pattern. The supervision of an assistant placed on the patient's healthy side is recommended in the first sessions in order to ensure greater safety to the patient. Constant supervision should be provided by Indego specialist during the whole treatment.
15786616|NCT04559711|Other|Strengthening coverage and quality of nutrition services during ANC|Intervention clusters will receive inputs both at facility level and community level. The supply side inputs will include efforts for improving facility readiness, quality of nutrition services during ANC, multiple micronutrient supplementation(MMS) and strengthening monitoring and supervision for ANC. On the other hand, community mobilization interventions will be carried out for demand creation. All public health facilities providing ANC services in the intervention area will be included; Union Health & Family Welfare Center, Community Clinic and Satellite Clinic.
15786617|NCT04559698|Behavioral|LGBTQ-affirmative CBT training|Participants will take part in 11-week LGBTQ-affirmative CBT training via Zoom for 1-hour per week.
15786618|NCT04559685|Combination Product|SONALA-001(ALA) and MR-Guided Focused Ultrasound device (MRgFUS)|SONALA-001(ALA) given 6-7 hours prior to receiving the MRgFUS.
15786619|NCT04559672|Procedure|Cervical laminoplasty surgery|The posterior standard cervical laminoplasty procedure with ARCH mini-plate fixation
15786620|NCT04559672|Procedure|Cervical laminectomy and fusion surgery|The posterior standard cervical laminectomy and fusion surgery procedure with lateral mass screws fixation
15786621|NCT04559659|Other|Respiratory muscle strength|Pimax and Pmax will be performed according to the (ATS) and (ERS). A Manovacuometer (Analog M 120, GlobalMed) with a range between 0-120cmH2O will be used. The elderly should undergo forced inspiration after maximal expiration and forced expiration after maximal inspiration through a mouthpiece with a hole to prevent closure of the glottis to evaluate Pimax and Pmax. The elderly should sustain the inspiration for 1 second. Three measurements will be performed, with a one-minute interval between them, with less difference equal to 10% between them, the higher value will be used.
15786622|NCT04559646|Procedure|Pacemaker implantation|Implantation of the pacemaker due to indications in patients with atrioventricular block, sick sinus syndrome, atrial fibrillation with impaired atrioventricular conduction or other.
15786623|NCT04559646|Drug|"Haemostatic solution Haemoblock application"|"Haemostatic solution Haemoblock will be used after pocket formation during pacemaker implantation."
15786624|NCT04559646|Drug|Saline solution application|Saline solution will be used after pocket formation during pacemaker implantation.
15786625|NCT04559646|Diagnostic Test|Ultrasound of pacemaker pocket|Pacemaker pocket ultrasound examination to diagnose pocket hematoma 3-5 days after surgery.
15786626|NCT04559646|Diagnostic Test|Blood sampling|Blood sampling for Platelet, Prothrombin, Fibrinogen, International Normalized Ratio, Creatinine, Albumin evaluation.
15786627|NCT04559646|Diagnostic Test|Echocardiography|Heart ultrasound examination for left ventricular ejection fraction measurement.
15786628|NCT04559633|Other|cognitive and behavioral therapy (CBT)|"The CBT program is delivered by a multidisciplinary team with 4 half day hospitalization that includes individual, group CBT and education time (2 hours per day delivered by the teacher). Participants have homework to do in their own time at home.
~CBT is a manualized program with anxiety psychoeducation, stress management, cognitive restructuration, problem solving techniques, progressive exposure, assertiveness exercises and self-esteem work."
15786629|NCT04559620|Other|Maternal voice|Maternal voice (song/ words) played in the incubator for 30mins x4/day x 7 days
15786630|NCT04559607|Drug|Camrelizumab|Camrelizumab: 200mg, iv, Q3W
15786631|NCT04559607|Device|TACE|TACE if necessary
15786632|NCT04559607|Drug|Apatinib|Apatinib: 250m, po, QD
15786633|NCT04559581|Drug|Nintedanib|Capsules
15786634|NCT04559568|Drug|LY3522348|Administered orally.
15786635|NCT04559568|Drug|Placebo|Administered orally.
15786636|NCT04559568|Drug|Midazolam|Administered orally to some participants.
15786637|NCT04559555|Drug|Nilotinib|The compassionate use dose of nilotinib is 400 mg orally twice daily and should not be taken with food
15786638|NCT04559529|Drug|Levetiracetam (LEV) 500 mg|The levetiracetam pill will look just like the placebo pill.
15786639|NCT04559529|Drug|Placebo|The placebo pill will look just like the levetiracetam pill, but does not contain any levetiracetam.
15786640|NCT04559516|Behavioral|Exercise Intervention|"The Ethica mobile app will provide a daily alert accompanied by a short educational statement about PAH, disease self-management tips, dietary and nutritional advice, goal setting, and a motivational statement to encourage patients.
~Participation with each session will be assessed by a mobile app-embedded survey administered at the end of the day. Patients will be presented with weekly alerts to complete validated patient-reported quality of life questionnaires using the EmPHasis-10 and the Living with Pulmonary Hypertension Questionnaire, as well as the PRAISE self-efficacy score for pulmonary rehabilitation. The app will also ask patients to report their WHO/NYHA functional class every week. Using in-app buttons, participants can log adverse events associated with each exercise session."
15786641|NCT04559516|Behavioral|Standard Care|Participants will be provided usual care administered at the PH clinic at the University of Calgary and no supervised exercise session will be performed.
15786642|NCT04559503|Other|Progressive relaxation exercises|Progressive relaxation exercises are those involving the voluntary, regular and consecutive relaxation of the muscles until there is relaxation all over the body. PMR are consisted of taking a deep breath and then tensing and relaxing muscles in both hands and arms, shoulders, chest, abdomen, hips, legs, feet, and face regions. The training was given in line with the CD that was prepared by the Turkish Psychologists Association as three-part relaxation exercises. The first part of the CD contains the definition, purpose and applications to consider when doing the exercises and a definition of 10-minute deep relaxation. In the second 30-minute section, relaxation exercises are explained accompanied by the sound of streams and oral instructions. The last section, which consists of 30 minutes, contains only relaxation music without instructions.
15786643|NCT04559477|Other|Static extension endurance exercise|"Static extension endurance exercise were performed, 10 repetitions with 10 sec hold of each of exercises Heating pad:15 mins TENS: 15 mins
~35 min/session, 3 sessions/week for 6 weeks"
15786644|NCT04559477|Other|Dynamic extension endurance exercise|"Dynamic extension endurance exercise with 10 repetitions of each of exercises which has been performed Heating pad:15 mins TENS: 15 mins
~35 min/session, 3 sessions/week for 6 weeks"
15786645|NCT04559464|Device|AeriSeal|The AeriSeal Foam functions by blocking both small airways and collateral channels causing absorption atelectasis in the treated region of the lung. Occlusion with the foam also yields a targeted fibrotic response which durably reduces lung hyperinflation. The reduction in hyperinflation allows the healthier parts of the lung to re-inflate and improve breathing mechanics and gas exchange. In this study, the AeriSeal delivery will be limited to three segments that contain the collateral channel(s) between lung lobes. A minimum 10 mL volume of AeriSeal will be delivered per segment, with a total delivered volume limit of 40 mL per subject (including re-treatment, if needed) in a total of three segments.
15786646|NCT04559464|Device|Zephyr Valves|The Zephyr Valves are implantable bronchial valves intended to control airflow in order to improve lung function in patients with hyperinflation associated with severe emphysema and/or to reduce air leaks.
15786647|NCT04559438|Other|Rotary Neoniti GPS file|Glide path creation will be achieved using Neoniti GPS file (15/.03). The file will be introduced passively inside the canal, in continuous rotation at a constant speed between 300 and 500 rpm and torque of 1.5 N.
15786648|NCT04559438|Other|Manual stainless steel K-files|Glide path preparation will be done by hand instrumentation using K-files #10 and 15.
15786649|NCT04559425|Drug|Dexamethasone|All management decisions are made by the primary physician and may include: 1) no treatment with dexamethasone or 2) treatment with dexamethasone from the time of enrollment
15786650|NCT04559425|Other|No Dexamethasone|All management decisions are made by the primary physician and may include: 1) no treatment with dexamethasone or 2) treatment with dexamethasone from the time of enrollment
15786651|NCT04559412|Device|Sofusa DoseConnect|25 to 50 mg Enbrel® administered by the Sofusa® DoseConnect™ delivery system once weekly for 12 weeks
15786652|NCT04559412|Drug|Enbrel|25 to 50 mg Enbrel® administered by the Sofusa® DoseConnect™ delivery system once weekly for 12 weeks
15786653|NCT04559399|Procedure|smiley face shape rod|For treatment of isthmic spondylolithesis a transpedical screws for the same level and rod revolve around spinal process to stabilization of pars interarticularis of the same segment after removes bone at the margine of defects pars till reach to healthy bleed margine then put bone graft at the defect then stablizing pars and bone graft by rods.
15786654|NCT04559386|Other|Survey|Questionnaire
15786655|NCT04559373|Other|Virtual Reality and Field Training (VRFT)|The VRFT intervention involves the intensive practice of community ambulation skills. Some of the training sessions will be performed in a virtual environment, while others will consist of field training exercises in the community. During the intervention, stroke participants will be invited to practice different dimensions of community ambulation, such as postural transitions, avoiding other pedestrians, dual-task walking, etc.
15786656|NCT04559360|Device|PRESTOapp|The intervention group will be asked to use the app for a period of 2 months.
15786657|NCT04559347|Drug|Liposomal Bupivacaine (EXPAREL®)/Bupivacaine|Single shot for erector spinae block
15786658|NCT04559347|Drug|Ropivacaine (0.5% bolus followed by 0.2% infusion)|Continuous catheter infusion for erector spinae plane block
15786659|NCT04559334|Device|Tetrasodium EDTA Catheter Lock Solution|KiteLock™ 4% Sterile Catheter Lock Solution is a single use, clear, colorless and sterile solution. It is free of preservatives, alcohol and latex and is non-pyrogenic. KiteLock™ 4% is an aqueous solution containing a mixture of edetate tetrasodium and edetate trisodium. The solution composition is equivalent to 28 mg/mL edetate. EDTA is a known chelator. This means it has an affinity for metals and elements such as calcium. As a primary mechanism of action, it acts as a space occupying solution to prevent blood from entering the tip of the catheter when the catheter is not in use. As a secondary mechanism of action, it acts as an in vitro anticoagulant. This dual action decreases the risk of clot formation, consequently thrombolytic occlusions and by extension decreases the risk of CLABSI.
15786660|NCT04559321|Procedure|Fragmentation of calculi with 100 W Holmium laser or LithoClast Trilogy EMS and 1.5 mm x 440 mm probe, according to randomization.|General anesthesia, Valdivia-Galdakao position, cystoscopy and ascending pyelography will be performed. A systematic nephroscopy will be performed and once the calculation will proceed to its fragmentation with 100 W Holmium laser or LithoClast Trilogy EMS and 1.5 mm x 440 mm probe, according to randomization
15786661|NCT04559308|Drug|Metformin|first-line anti-diabetic drug
15786662|NCT04559308|Drug|Chemotherapy|First line neoadjuvant chemotherapy protocol
15786663|NCT04559295|Biological|Bone Marrow Concentrate|The intradiscal delivery of bone marrow concentrate (BMC) into discs, facet , epidural space, and sacroiliac joints
15786664|NCT04559282|Device|New Sound Processor|The new Sound Processor is intended to be used as part of the Cochlear Baha System which uses bone conduction to transmit sounds to the cochlea. The New Sound Processor is indicated for patients with up to 55 dB sensorineural hearing loss.
15786665|NCT04559269|Other|No intervention|patients have benefited from maintenance wakefulness tests as part of their clinical evaluation
15786667|NCT04559243|Diagnostic Test|Transthoracic Echocardiography|After the surgey, the tests data will be collected during 8 visits when the subjects go back to the hospital.
15786669|NCT04559217|Biological|Radiopharmaceutical 68Ga-DOTATATE|Injection of 68Ga-DOTATATE followed by PET/CT acquisition
15786670|NCT04559204|Biological|IIV4 and PPV23|imultaneously immunization of 23-valent pneumococcal polysaccharide vaccine (PPV23) and quadrivalent inactivated influenza vaccine (IIV4)
15786671|NCT04559204|Biological|IIV4|administrated with IIV4 only
15786672|NCT04559204|Biological|PPV23|administrated with PPV23 only
15786673|NCT04559191|Device|continuous glucose monitoring (CGM)|CGM (FreeStyle Libre Pro®, Abbott, Chicago, Illinoi, the United States)
15786674|NCT04559178|Other|Fluid challenge|fluid challenge administration when patient is in the gray zone
15786675|NCT04559165|Other|sericin and chitosan cream|sericin and chitosan cream
15786676|NCT04559152|Dietary Supplement|Zinc Supplementation Group|Enrolled subjects received zinc capsule 20mg daily in the morning after meal for 12 weeks
15786677|NCT04559152|Dietary Supplement|Placebo Group|Enrolled subjects received placebo tablet, which was inserted into capsule of the same shape and color as zinc capsule, daily in the morning after meal for 12 weeks
15786678|NCT04559139|Drug|Cisplatin|Given IV
15786679|NCT04559139|Drug|Gemcitabine Hydrochloride|Given IV
15786680|NCT04559139|Procedure|Lymphadenectomy|Undergo portal lymphadenectomy
15786681|NCT04559139|Procedure|Partial Hepatectomy|Undergo partial hepatectomy
15786684|NCT04559113|Drug|Methylprednisolone Injectable Product|"0.5mg to 1mg/Kg methylprednisolone or equivalent dexamethasone dose (to a maximum of 20mg) given daily x 5 to 7-days or
~Methylprednisolone 1 mg/kg daily IV for 5 days followed by 40 mg daily x 3 days, followed by 10 mg daily x 2 day."
15786685|NCT04559100|Radiation|chest radiography|6 and 12 months after hospital discharge. If the study is normal at 6 months it will not be repeated at 12 months.
15786686|NCT04559100|Radiation|thoracic computed tomography scan|6 and 12 months after hospital discharge, if the patient had a CT scan upon admission to the hospital. If the study is normal at 6 months it will not be repeated at 12 months.
15786687|NCT04559100|Diagnostic Test|spirometry|6 and 12 months after hospital discharge. If the study is normal at 6 months it will not be repeated at 12 months.
15786688|NCT04559100|Diagnostic Test|Diffusing capacity of carbon monoxide|6 and 12 months after hospital discharge. If the study is normal at 6 months it will not be repeated at 12 months.
15786689|NCT04559100|Diagnostic Test|6 minute walk test|6 and 12 months after hospital discharge. If the study is normal at 6 months it will not be repeated at 12 months.
15786690|NCT04559100|Diagnostic Test|saint george respiratory questionnaire|6 and 12 months after hospital discharge.
15786691|NCT04559087|Procedure|Laparoscopic Surgery|"NOSES:Natural orifice specimen extraction (NOSE) is the opening of a hollow viscus that already communicates with the outside world, such as the vagina or distal gastrointestinal tract, in order to remove a specimen. The premise of this technique is to reduce the trauma required to remove the specimen with the expectation that this may improve outcomes.
~Conventional Laparoscopic Surgery:Surgical specimens were taken out through abdominal wall."
15786692|NCT04559074|Drug|Amlodipine|Amlodipine 1mg/ml Oral Solution; starting dose 1-2mg per day for patients not on amlodipine at entry; starting dose equivalent to current dose for patients on amlodipine at entry or at next 1-2mg dose step (according to clinical need based on the Investigator's judgement). Investigation of whether gradually increasing the dose of liquid amlodipine (can be an add-on to existing amlodipine tablets) in small increments (e.g. 1-2mg) will enable blood pressure control within the sequence 1mg, 2mg, 3mg, 4mg, 5mg, 6mg, 7mg, 8mg, 9mg to a maximum of 10mg amlodipine per day.
15786693|NCT04559061|Device|Cardiac ablation procedure|Retrospective data will be collected from cases where successful ablation was completed.
15786694|NCT04559048|Drug|FK506|FK506 (tacrolimus), a calcineurin inhibitor, is widely used as an immunosuppressant to lower the risk of organ rejection after organ transplantation
15786695|NCT04559035|Other|Nasal lavage|Twice daily nasal lavage.
15786696|NCT04559022|Procedure|Fat Grafting|This single-center, clinical trial will assess the efficacy and tolerability of the autologous fat grafting when used on men and women with acne scars on the face.
15786697|NCT04558957|Device|FLEBOGRIF|The catheter is a device dedicated to mechano-chemical ablation of insufficient veins of the superficial system.
15786698|NCT04558944|Device|Extracorporal Shock Wave Therapy|Acoustic high amplitude waves with Energy Flux Density of 0.15mJ/mm 2 and 512 pulses per session. A total of two sessions per week during a 4-week period.
15786699|NCT04558931|Drug|CellProtect|In vitro expanded and activated autologous NK cells
15786700|NCT04558931|Drug|Isatuximab|Naked immunoglobulin (Ig) G1 monoclonal antibody (mAb) that selectively binds to the human cell surface antigen molecule classified as cluster of differentiation (CD) 38
15786704|NCT04558905|Other|Face-to-face medical visits|Face-to-face medical visits
15786705|NCT04558905|Other|Alternating face-to-face medical visits and video medical consultations|Alternating face-to-face medical visits and video medical consultations
15786706|NCT04558892|Drug|Enoxaparin|
15786707|NCT04558879|Behavioral|CT|12 weeks of exercise Cardiovascular Training
15786708|NCT04558879|Behavioral|RT|12 weeks of exercise Resistance Training
15786709|NCT04558866|Drug|Testosterone Cypionate|One administration every 63 cycles until progression or unacceptable toxicity or completion of treatment phase (54 weeks; 6 cycles), whichever comes first.
15786815|NCT04557995|Procedure|Erythropheresis|Draw blood from patient's vein and remove red blood cells as other components would be transfused back.
15786710|NCT04558866|Drug|Darolutamide|During 4 weeks, from day 29 to day 56 of each 63-day cycle (+- 3 days) until progression or unacceptable toxicity or completion of treatment phase (54 weeks; 6 cycles), whichever comes first.
15786711|NCT04558853|Drug|autologous NK cells|Autologous ex vivo expanded and activated NK cells
15786713|NCT04558827|Other|Low Carbohydrate Diet|Dietary choices are counseled to come primarily from lean meats, eggs, nuts, seeds, vegetables and berries.
15786714|NCT04558827|Other|Time Restricted Feeding|Participants will be asked to have 2 meals within an 8 hour period, preferably before 2pm.
15786715|NCT04558814|Diagnostic Test|Serum galectin-9 level|Determining level of galectin-9 in sera of patients of SLE with different disease activity and organ affection and Sera of control group
15786716|NCT04558801|Device|Mobile application-based lifestyle change program|Usage of the Mobile application-based lifestyle change program
15786717|NCT04558788|Diagnostic Test|Immunohistochemistry on intestinal biopsies|Immunohistochemistry will be performed on human intestinal biopsies
15786718|NCT04558775|Other|Observational|no intervention
15786719|NCT04558749|Other|State-trait anxiety inventory scale|This scale is composed of two parts, part one measures anxiety traits and part two measures anxiety state. Each part comprises 20 statements. This scale is a (4) point scale, with a score ranging a minimum of 20 grades to a maximum of 80 grades.
15786720|NCT04558749|Other|Edinburgh Postnatal Depression Scale (EDPS)|The EPDS is a self-report measure that focuses on the cognitive symptoms of depression. It excludes somatic items that might generate false positives both during pregnancy and after childbirth.7 The EPDS consists of 10 items, each scored 0-3 points, with a potential scale score of 0-30.
15786721|NCT04558736|Drug|Anti-Thymocyte Globulin (Rabbit)|Given intravenously (IV)
15786722|NCT04558736|Drug|Fludarabine|Given intravenously (IV)
15786723|NCT04558736|Drug|Cyclophosphamide|Given intravenously (IV)
15786724|NCT04558736|Drug|Mesna|Given intravenously (IV)
15786725|NCT04558736|Drug|G-CSF|Filgrastim is a human granulocyte colony-stimulating factor (G-CSF), produced by recombinant DNA technology. Dosage and Route of Administration: 5mcg/kg subcutaneous or intravenous daily until ANC >2000 for 2 consecutive days, or as clinically indicated
15786726|NCT04558736|Radiation|Total Lymphoid Irradiation (TLI)|TLI will be given at 800 cGy total dose in 4 fractions.
15786727|NCT04558736|Device|CliniMACS|The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells.
15786728|NCT04558736|Biological|HPC, A Infusion|Given intravenously Day 0-HPC, A Infusion (TCR αβ+/CD19+-depleted graft)
15786729|NCT04558736|Biological|CD45RA-depleted DLI|CD45RA-depleted DLI will be given at least ONE week after engraftment
15786730|NCT04558723|Other|ICD/CRT-D implantation|ICD/CRT-D implantation (if indicated)
15786731|NCT04558697|Drug|Shepherd's Purse extractum oleosum vagitories|Shepherd's Purse extractum oleosum vagitories will be administered once daily for 5 days
15786732|NCT04558697|Drug|Tea tree oil vagitories|Tea tree oil vagitories will be administered once daily for 5 days
15786733|NCT04558697|Drug|Hyperici extractum oleosum vagitories|Hyperici extractum oleosum vagitories will be administered once daily for 5 days
15786734|NCT04558697|Drug|Vagitories - Probiotic|Vagitories - Probiotic will be administered once daily for 5 days
15786735|NCT04558684|Drug|Chemotherapy|CAPOX (6 cycles): Oxaliplatin(130mg/m2) on day 1 of each cylce and Capecitabine: Dose of 2000mg/m2,14 days, q3w
15786736|NCT04558684|Drug|Immunotherapy|Camrelizumab (6 cycles): 200mg on day 1 of each cycle, q3w
15786737|NCT04558684|Radiation|IMRT|Radiotherapy (5 Gy x 5 fractions)
15786738|NCT04558671|Other|asthma exacerbations|to collect the number of asthma exacerbations between the 2 latent classes of patients within the year following bronchoscopy
15786739|NCT04558658|Diagnostic Test|Complete Blood Count|neutrophil to lymphocyte ratio
15786740|NCT04558645|Other|Online Survey|Online surveys will be applied to all participants
15786741|NCT04558619|Behavioral|Kōmmour Prenatal|Centering Pregnancy, a group prenatal care model, is a promising intervention that challenges the standard model of one-on-one counseling of prenatal care. The model, is currently implemented at the UAMS, but as of yet to be adapted for Pacific Islanders. Centering Pregnancy replaces the individual prenatal care visit with a group model for obstetrically low-risk women. This model provides substantially more health promotion content than the traditional one-on-one prenatal care model. The intervention occurs from week 14 of pregnancy through birth, following the same same schedule as individual care. Group visits are 90-120 minutes each and follow a unique structured curriculum that incorporates standards of care. In the group setting, credentialed prenatal providers conduct a one-on-one assessment with each patient (30 min) and then facilitate group discussions on the topics of pregnancy, using adult learning principles (60-90 min).
15786742|NCT04558606|Device|Sonic Toothbrush|Sonic Toothbrush (Philips Sonicare Flexcare Platinum Toothbrush®)
15786743|NCT04558606|Device|Manual Toothbrush|Manual brushing (Technique Pro - GUM® Sunstar Italiana SRL)
15786744|NCT04558593|Procedure|Active surveillance|Per standard of care: Imaging and blood tests every 6 months (3 first years) and annually (following years)
15786745|NCT04558593|Procedure|Surgery|Per standard of care: partial or full resection of the kidney
15786746|NCT04558580|Drug|Rufinamide|Rufinamide
15786747|NCT04558567|Drug|Vogelxo|50mg (1 tube, 5g gel) to 100mg (2 tubes, 10g gel)
15786748|NCT04558554|Other|pharmacy-based PrEP delivery|The intervention is a new model of PrEP delivery that has never been tried before in an African setting: pharmacy-based PrEP delivery.
15786816|NCT04557982|Procedure|A painful procedure (peripheral venepuncture)|The child will undergo a peripheral venepuncture during a scheduled visit to a hospital clinic and routinely provided care.
15786817|NCT04557956|Drug|Dabrafenib Mesylate|Given PO
15786749|NCT04558541|Other|Sensitivity to phonological rules|Assess whether children with developmental language disorder (DLD) are sensitive to different phonological patterns that are predicted to align with development of morphosyntax or the lexicon; children with speech sound disorder (SSD) are not predicted to be sensitive to the same phonological patterns.
15786750|NCT04558541|Other|Sensitivity to semantic category cues.|Assess whether all children, including those with DLD, show improved learning of OR rules when a semantic category cue is used.
15786751|NCT04558528|Diagnostic Test|Novel in vitro diagnostics and medical applications|Novel in vitro diagnostics and medical applications
15786752|NCT04558515|Diagnostic Test|Novel malaria diagnostics & tools|Next generation microscopy tools for malaria diagnosis and medical applications
15786753|NCT04558502|Drug|Minocycline hydrochloride capsule|14-day minocycline-based bismuth quadruple regimen
15786754|NCT04558502|Drug|Clarithromycin|14-day clarithromycin-based bismuth quadruple regimen
15786755|NCT04558489|Behavioral|IPR + GMI|The IPR + GMI intervention aims to impact reported hopelessness, attitudes to treatment, and view of self as changeable as well as targets treatment attendance and utilization.
15786756|NCT04558476|Biological|Convalescent Plasma|2 units of convalescent plasma
15786757|NCT04558476|Other|Standard of Care|Gold Standards
15786758|NCT04558463|Drug|Favipiravir|"The favipiravir group received loading dose of 1600 mg twice a day (3200 mg/day) on the first day and continued with 600 mg twice a day (1200 mg/day) for the next 2nd - 7th day in addition to the standard therapy.
~Standard therapy: administration of azithromycin 500 mg/day or levofloxacin 750 mg/day for 5 days, chloroquine (either Sulphur-based chloroquine 600 mg/day or chloroquine phosphate 100 mg/day or hydroxychloroquine 400 mg/day) for 5-7 days, vitamin C, oxygen therapy according to the patients clinical condition, comorbid therapy and other symptomatic treatment such as antipyretic drug"
15786759|NCT04558463|Drug|Oseltamivir 75mg|"The oseltamivir group was given twice a day of 75 mg of oseltamivir (150 mg/day) for 7 days in addition to standard therapy
~Standard therapy: administration of azithromycin 500 mg/day or levofloxacin 750 mg/day for 5 days, chloroquine (either Sulphur-based chloroquine 600 mg/day or chloroquine phosphate 100 mg/day or hydroxychloroquine 400 mg/day) for 5-7 days, vitamin C, oxygen therapy according to the patients clinical condition, comorbid therapy and other symptomatic treatment such as antipyretic drug"
15786760|NCT04558450|Diagnostic Test|carotid-femoral pulse-wave velocity|early vascular aging tests
15786761|NCT04558437|Other|Questionnaire|"Questionnaire at M0 M3 M6:
~PCL-5 (Post-Traumatic Stress Disorder Checklist Scale, version DSM-5) HAD (Hospital Anxiety and Depression Scale) SDS (Sheehan Disability Scales)"
15786762|NCT04558424|Dietary Supplement|zinc gluconate and ascorbic acid|This group will consist of 50 patients who will receive 220 mg zinc and 1gm ascorbic acid for 10 days in addition to their standard treatment.
15786763|NCT04558411|Behavioral|Dialectical Behavioral Therapy (DBT) Skills|14 brief videos that teach DBT skills.
15786764|NCT04558398|Other|Resistance exercise training|"Each session will be performed at home, with resistance bands used to provide resistance. Participants will be guided to increase the resistance if over 15 repetitions can be performed prior to fatigue. Weekly contact will be made with participants to encourage participation and to guide the exercise.
~Each session will include:
~2 min warm-up jogging on the spot
~2 sets of 12-15 repetitions of:
~Squats
~Hip flexion
~Hip extension
~Hip abduction
~Seated row
~Bench press
~Lateral raises
~2 min jogging on the spot cooldown."
15786765|NCT04558398|Other|High-intensity interval training|"Each session will include:
~2 min warm-up: jogging on the spot
~Each of the following exercises performed for 60seconds, interspaced by 90 seconds rest
~Star jumps
~Standing squats
~On-the-spot sprints
~Standing squats
~Star jumps
~2 min cool-down: jogging on the spot
~Participants will be contacted weekly to encourage participation and to guide the exercise"
15786766|NCT04558385|Diagnostic Test|IgG SARS CoV2|IgG SARS CoV 2 will be checked in serum of COVID 19 recovered population
15786767|NCT04558372|Other|exhaled breath sampling|The participants breath through non-rebreathing mask until the reservoir bag is full. The reservoir bag is connected to Hepa-filter at one side, and another side of Hepa-filter is connected to the electronic-nose (Genosvid) device.
15786768|NCT04558372|Other|exhaled breath sampling|The participants breath through non-rebreathing mask until the reservoir bag is full. The reservoir bag is connected to Hepa-filter at one side, and another side of Hepa-filter is connected to the electronic-nose (Genosvid) device.
15786769|NCT04558372|Other|exhaled breath sampling|The participants breath normally using a mask for 2 times then they are asked to inhale and exhale in a forced expiratory volume through an e-nose tube connected to the Hepa-filter at the inlet.
15786770|NCT04558359|Other|Standard of Care|These patients will receive standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.
15786771|NCT04558359|Drug|Angiotensin II|These patients will receive angiotensin II in addition to standard of care treatment. Plasma renin levels and biomarkers of renal function will be measured.
15786772|NCT04558346|Drug|Ghrelin (OXE-103)|40ug/kg twice daily by self-injection
15786773|NCT04558346|Drug|Placebo|40ug/kg twice daily by self-injection
15786774|NCT04558333|Other|blood and exhaled breath specimens|identification of possible biomarkers
15786775|NCT04558307|Diagnostic Test|Pilot a rapid SARS-CoV-2 testing strategy|Rapid testing strategy at an FQHC using Mayo Clinic Laboratory (MCL) diagnostic processing with a real-time polymerase chain reaction assay for SARS-CoV-2 and a Mayo Clinic drive-through collection protocol.
15786776|NCT04558307|Other|Community-driven messages to promote COVID-19 testing|A one-time communication about the availability of COVID-19 testing at the FQHC to patients randomized to the intervention group using any available means of communication (text and/or mailed letter).
15786780|NCT04558281|Drug|Active ropivacaine 0.3% erector spinae plane perineural administration|Ropivacaine 0.3% administration via an erector spinae plane perineural catheter
15786781|NCT04558281|Drug|Placebo erector spinae plane perineural administration|Normal saline administration via an erector spinae plane perineural catheter
15786818|NCT04557956|Drug|Tazemetostat Hydrobromide|Given PO
15786819|NCT04557956|Drug|Trametinib Dimethyl Sulfoxide|Given PO
15786782|NCT04558268|Drug|Prednisone|"Prednisone is a corticosteroid. It prevents the release of substances in the body that cause inflammation. It also suppresses the immune system.
~Prednisone is used as an anti-inflammatory or an immunosuppressant medication. Prednisone treats many different conditions such as allergic disorders, skin conditions, ulcerative colitis, arthritis, lupus, psoriasis, or breathing disorders."
15786783|NCT04558268|Drug|Progesterone|"Progesterone is a female hormone important for the regulation of ovulation and menstruation.
~Progesterone is used to cause menstrual periods in women who have not yet reached menopause but are not having periods due to a lack of progesterone in the body. It is also used to prevent overgrowth in the lining of the uterus in postmenopausal women who are receiving estrogen hormone replacement therapy."
15786784|NCT04558268|Dietary Supplement|vit D|Vitamin D acts on our bones, intestines, kidneys and parathyroid glands to keep calcium in balance throughout our body. Vitamin D receptors are also located within our cardiovascular system, lungs, pancreas, skeletal muscle, skin, and reproductive organs. In summary, vitamin D is a prohormone that is essential for good health.
15786785|NCT04558268|Dietary Supplement|Iron Supplement|Iron is one of the minerals in the human body. It is one of the components of hemoglobin, the substance in red blood cells that helps blood carry oxygen throughout the body.
15786786|NCT04558268|Dietary Supplement|Folic Acid|"Folic acid is a type of B vitamin that is normally found in foods such as dried beans, peas, lentils, oranges, whole-wheat products, liver, asparagus, beets, broccoli, brussels sprouts, and spinach.
~Folic acid helps your body produce and maintain new cells, and also helps prevent changes to DNA that may lead to cancer."
15786787|NCT04558255|Diagnostic Test|A machine-learning method which can robustly discriminate early-stage lung cancer patients from controls|In our study, we intend to integrate molecular features obtained through liquid biopsy and clinical data of lung cancer patients, and develop and prospectively validate a machine-learning method which can robustly discriminate early-stage lung cancer patients from controls.
15786788|NCT04558242|Device|Genix|Low Level Light (LEDs)
15786789|NCT04558242|Device|Sham|Incandescent Bulbs Colored Red
15786790|NCT04558229|Other|Additional Standardized Counseling|Research staff will follow a script designed to give unbiased, medically accurate information regarding bleeding changes that may occur with use of a contraceptive ENG implant.
15786791|NCT04558216|Drug|Vonoprazan|20 mg tablets administered orally
15786792|NCT04558216|Drug|Rifampin|600 mg (Two 300 mg capsules)
15786793|NCT04558190|Drug|Intralipid, 20% Intravenous Emulsion|Lipid infusion
15786794|NCT04558190|Dietary Supplement|MitoQ|Oral administration of MitoQ capsules
15786795|NCT04558190|Drug|Salbutamol|Beta2-agonist infusion
15786796|NCT04558177|Device|Direct current stimulator|HDCprog connected to a direct current stimulator, controls the number of stimulations (maximum 99), the intensity (up to 1.5mA per channel), the duration (maximum 20min), and the minimum interval between two consecutive simulations (max 1168 hours). A sham condition is also available which will ramp the stimulation to a preset maximum level and then immediately reduces the stimulation to 0.
15786797|NCT04558164|Device|Active Theta Burst Stimulation|Theta burst transcranial magnetic stimulation (TBS) will be delivered at 80% of motor threshold (MT).
15786798|NCT04558164|Device|Sham Theta Burst Stimulation|Sham stimulation will be delivered at 10% of motor threshold (MT), with all other parameters matching the active TBS condition.
15786800|NCT04558138|Other|Discharge timing|Patients will be discharged home on the day of surgery as opposed to POD #1
15786802|NCT04558112|Drug|L-DOPA|two gel capsules with 100mg L-DOPA (with 25 mg carbidopa to inhibit peripheral decarboxylase)
15786803|NCT04558112|Drug|Placebo|two gel capsules of placebo
15786804|NCT04558099|Behavioral|MBSR|Described previously
15786805|NCT04558086|Device|Virtual reality|To develop the intervention strategies of hospitalized school-age children with IV placement, using interactive virtual reality(VR)as a guiding play and emotional catharsis play, to further examine the effectiveness of reducing IV pain and fear.
15786806|NCT04558086|Device|Photo book|To develop the intervention strategies of hospitalized school-age children with IV placement, using Photo book to further examine the effectiveness of reducing IV pain and fear.
15786807|NCT04558073|Behavioral|Body Project (BP)|"The BP intervention offers discussions and exercises to make participants realize the cost of pursuing social ideals valuing thinness. This produces cognitive dissonance, a cognitive discomfort due to a contradiction between speech and beliefs, which motivates to modify one's beliefs. The curriculum includes discussions on techniques of the advertising industry and the unique ideal of beauty promoted worldwide, as well as on the costs of pursuing the thin-ideal. Participants are also challenged to try behaviours they avoid because their appearance bother them. Societal activism actions are also discussed."
15786808|NCT04558073|Behavioral|Healthy Weight Program (HW)|The HW intervention allows participants to make personalized changes in their diet and physical activity each week gradually, to aim for a health-ideal rather than a thin-ideal. The intervention is based on small changes, based on behavioural change techniques. Advice is given on what types of changes introduce to promote health, and how to implement changes sustainably. Difficulties are discussed in the group with a problem-solving approach. The last session introduces a long-term view of lifestyle change.
15786809|NCT04558060|Other|Virtual Standardized Patient|Computer program that presented a virtual human patient
15786810|NCT04558060|Other|Academic Study|Study of a summary of motivational interviewing concepts and techniques.
15786811|NCT04558034|Other|cryotherapy|cryotherapy will be delivered
15786812|NCT04558021|Drug|Niclosamide suspension|200mg/10ml
15786813|NCT04558021|Other|Placebo|10ml placebo(absent of niclosamide)
15786814|NCT04558008|Behavioral|Online MBSR|Described previously
15786820|NCT04557943|Drug|Prolotherapy|"Prolotherapy injection is performed intra-articularly and extra-articularly by a physician. Intra-articular injection with 25% dextrose will be carried out with the following details: 5 mL of 40% dextrose, 2 mL of lidocaine, and 1 mL of aqua dest are inserted into the 10-mL syringe, then 5 mL are injected with the superolateral approach. An extra-articular injection with 15% dextrose will be carried out with the following details:
~in the 10-mL syringe 4 mL of 40% dextrose, 2 mL lidocaine, and 4 mL of distilled water are injected, to make a total of 30-40 mL injections. Treatment will be carried out on day 1st, 29th, and 57th."
15786821|NCT04557943|Drug|Sodium Hyaluronate|Hyaluronan sodium injection is performed intra-articularly using 2 mL of Adant® Disposable. The treatment will be given five times, on day 1st, 8th, 15th, 22nd, and 29th
15786822|NCT04557930|Behavioral|Hopewell Hospitalist Video Game|Hopewell Hospitalist is a customized theory-based adventure video game that uses narrative engagement to educate physician players on advance care planning to increase physicians' likelihood of engaging in and billing for ACP conversations.
15786823|NCT04557904|Other|Craniocervical flexion exercises|Command the subject to be in crook lying position. Lock their finger to place their finger below the skull and retract the lower jaw and retract chin as far as possible. Subject has to slightly raise his/he skull a few centimeters. Fingers should be touching the cranium but not supporting it. Subject had to respire and hold the position. Subject has the move out the chin. Stop exercise and restart again. Perform this exercise for 10 times by holding this position for 20 sec at the start of the exercise, increasing it by 10 seconds every session commonly underwent pectoralis minor stretching before every session of exercise of 4 sets with 30 second's hold
15786824|NCT04557904|Other|Scapular stabilization exercises|The scapular stabilization exercises were made up of four stages: (1) In supine position, the patient was commanded to deep respire for the sake of relaxation by maintain the cervical and shoulder in relaxing position to take a deep breath to relax the body while holding her shoulders and neck in relaxing position. (2) The patient then flex her knees and placed her feet flat on the plinth, and maintain the pose without any cervical movement. Then the patient asked to raise her dominant arm to 90° shoulder flexion with full elbow extension and scapular protraction. This position was sustained for 10 seconds before going to initial position. Three laps of 10 repetitions with one-minute interval in between were performed. (3) In quadruped position, the patient raise her arms alternatively with shoulder abduction and 120 ° flexion. That posture was held for 10 seconds before returning to the starting position. (4) In sitting position
15786825|NCT04557878|Drug|Hypertonic Dextrose Solution|Patients in this group will receive an intra-articular injection of 12.5% hypertonic dextrose solution, once every month for three consecutive months, in conjugation with a maxillary CAD/CAM full-arch hard clear acrylic stabilization appliance.The point of needle entry will be 1 cm below the apex of the zygomatic arch and guided by ultrasound to ensure intra-articular injection in the superior joint space.
15786826|NCT04557878|Biological|Liquid Phase Concentrated Growth Factor (LPCGFs)|Patients in this group will receive single intra-articular injection of LPCGF in conjugation with a maxillary CAD/CAM full-arch hard clear acrylic stabilization appliance.
15786827|NCT04557865|Diagnostic Test|18F-PMPBB3 (APN-1607) PET imaging|"Name: 18F-PMPBB3 (APN-1607, MNI-958, or APN-0000455)
~Dosage form: injection form
~Strength: 5mCi/dose
~Dosage and administration: 5mCi, intravenous injection
~Mechanism of action (if known): bind to tau protein in the brain
~Pharmacological category: radiopharamceutical"
15786828|NCT04557852|Procedure|ATVM|Tailored anterior transvaginal mesh for pelvic organ prolapse
15786829|NCT04557839|Other|Traditional physical therapy balance exercise|"first phase : stepping forward, backward, and sideways on the exercise step stepping over blocks of various heights standing up from a chair, walking four steps forward,)A performing a range of motion and balance exercises (forward and backward rolling of the arms; bending the trunk forward and side to side);on a swiss ball. performed In a normal condition In first 20 m of each session 2nd phase Performing double-legged stance tandem walking forward and backward
~• Dosage of exercise was twice a week for 6 week each session comprise of 60 mints. Each set consisted of 4 periods of 11 exercises and rest of 40 sec .many exercise over time will turn into circuit training"
15786830|NCT04557839|Other|proprioception based balance training|"first phase : stepping forward, backward, and sideways on the exercise step stepping over blocks of various heights standing up from a chair, walking four steps forward,)A performing a range of motion and balance exercises (forward and backward rolling of the arms; bending the trunk forward and side to side);on a swiss ball. performed In a normal condition In first 20 m of each session 2nd phase Performing double-legged stance tandem walking forward and backward all exercise done under following condition.
~eyes open firm surfaces
~Eyes open soft surfaces
~Eyes closed firm surfaces
~Eyes closed soft surfaces (the soft surfaces will be a foam mate with 2.5 cm thick )
~These exercise will perform with turning the head side to side ad up and down
~Dosage of exercise was twice a week for 6 week each session comprise of 60 mints. Each set consisted of 4 periods of 11 exercises and rest of 40 sec .many exercise over time will turn into circuit training"
15786831|NCT04557826|Device|RD19|Experimental device that uses safe electromagnetic energy to stimulate the proximal repository of respiratory tract infectious disease pathogens
15786832|NCT04557800|Drug|DNL151|oral dose(s)
15786833|NCT04557800|Drug|Placebo|oral dose(s)
15786834|NCT04557787|Device|New intermittent catheters variation 1 and 2 for females|The new catheters are not named at this point but are intended for intermittent drainage of the bladder.
15786835|NCT04557774|Other|Cognitive function test|"Laboratory and imaging test
~Biochemical serum test: total bilirubin, alanine aminotransferase (ALT), haptoglobin, aspartate aminotransferase (AST), gamma glutamyltranspeptidase (GGT), alkaline phosphatase (ALP), albumin, blood urea nitrogen, creatinine, α-fetoprotein (AFP), prothrombin time, blood glucose, triglycerides, and total cholesterol.
~Baseline evaluations: family and alcohol history, X-ray, electrocardiography, blood tests for electrolyte, liver function, and viral markers
~Neuropsychological test
~-Attention, Language, Visuospatial, Memory, Frontal/executive"
15786836|NCT04557761|Device|microMend®|microMend® is a novel wound closure device that consists of arrays of tiny staples, known as Microstaples, which are attached to a backing material that is the size and shape of a butterfly closure. The Microstaples enable secure attachment of the device to the skin, allowing for the safe closure of wounds associated with surgery and traumatic injuries, such as lacerations. microMend is listed with the FDA and is available for sale in the United States.
15786837|NCT04557761|Device|Closure with Sutures|The Subject's laceration will be closed with sutures per regular institutional policies and procedures.
15786838|NCT04557748|Other|Observational|"Treatment:
~Up to five interactions: In-person visits at Baseline, 3 months, and 12 months after initial visit, and phone/online interaction at 6 months and 9 months after initial visit.
~Each in-person follow up visit is expected to last up to 2 hours and each phone/online interaction is expected to last up to 1½ hours.
~Answering questions about your general health and urinary symptoms - may be done remotely Physical exam Completing Self- Reported Measures questionnaires - may be done remotely Completing voiding/intake and food diaries, either online or on paper Weekly text message survey regarding symptom and treatment changes
~Biosample collection:
~At baseline: Up to 4 tablespoons of whole blood, dried blood spots, and urine At baseline: Whole blood will be collected with other biospecimens At 3 months: Up to 4 tablespoons of blood, dried blood spots and urine At 12 months: Dried blood spots"
15786839|NCT04557748|Other|Observational Controls|One in-person visit that is expected to last up to 2 hours Answering questions about your general health and urinary history Physical exam Completing Self- Reported Measures questionnaires Completing voiding/intake and food diaries, either online or on paper Biosample collection of up to 4 tablespoons of whole blood, dried blood spots, and urine
15786840|NCT04557748|Other|Central Sensitization|"One in-person visit expected to take up to 30 minutes, that include:
~Segmental Mechanical Hyperalgesia - a hand-held device with a small flat rubber surface will be placed above the pubic bone and forearm, and will apply pressure. Participant will be asked about the intensity and unpleasantness that they experience.
~Pinprick Temporal Summation - participant will receive tactile stimulation by a pointed skin probe (pinprick stimulator) being placed above the pubic bone and forearm. Participant will be asked to rate the sensation they are feeling.
~Current treatment information including prior surgery or procedures, medication use, other current treatment/therapy used at the time of the visit.
~Self-reported measures questionnaires"
15786841|NCT04557748|Other|Physical Activity and Sleep Tracker|"A physical activity and sleep monitor (Fitbit Charge 3 or similar) will be worn for a 2 week period starting at baseline prior to treatment and again at 3 months. During each 2 week period:
~The Fitbit will be worn both day and night to collect the most information. Text message reminders to wear the Fitbit will be sent. Daily text messages asking the number of nighttime voids you had."
15786842|NCT04557748|Other|Physical Activity and Sleep Tracker Controls|"A physical activity and sleep monitor (Fitbit Charge 3 or similar) will be worn for a 2 week period at baseline prior to treatment. During the 2 week period:
~The Fitbit will be worn both day and night to collect the most information. Text message reminders to wear the Fitbit will be sent. Daily text messages asking the number of nighttime voids you had."
15786843|NCT04557748|Other|Organ-Based|"One in-person visit involving:
~Urethral vibratory sensation threshold Urethral Pressure Profilometry Cystometry Uroflowmetry Lidocaine Pre-Treatment Cystometry"
15786844|NCT04557748|Other|Qualitative Assessment of Patients with Urinary Urgency|"Participation will include two interviews with a research assistant over the phone and are expected to take up to 60 minutes for each interview. The first interview will be done within four weeks from enrollment, before the start of treatment. The interview will include questions about participant's urinary urgency, including symptoms experienced, the onset of symptoms and other factors that affect urgency.
~Approximately three months after the start treatment the participant will be interviewed again. This interview will cover changes in symptoms and experience with treatment, such as side effects and satisfaction with treatment."
15786845|NCT04557735|Drug|Ravulizumab|Weight-based doses of ravulizumab will be administered intravenously as a loading dose regimen followed by maintenance dosing every 4 or 8 weeks, depending upon weight.
15786846|NCT04557735|Other|Best Supportive Care|Participants will receive medications, therapies, and interventions per standard hospital treatment protocols (unless specifically prohibited by the protocol).
15786847|NCT04557722|Procedure|0-30° Biplanar Fluoroscopic Puncture Techniques for Percutaneous Nephrolithotomy|after retrograde instillation of contrast through the ureteric catheter; the puncture of the desired calyx by using the 0-30 degree technique of C-Arm.
15786848|NCT04557722|Procedure|New 0-90° Fluoroscopic Puncture Techniques for Percutaneous Nephrolithotomy|after retrograde instillation of contrast through the ureteric catheter; the puncture of the desired calyx by using the 0-90 degree technique of C-Arm.
15786849|NCT04557709|Other|Medical Chart Review|Review of medical charts
15786851|NCT04557657|Drug|Active bio Activa|Cement that release fluoride
15786852|NCT04557657|Drug|Resin Cement|Resin Cement Convinonal
15786853|NCT04557644|Other|7-items-questionnaires addressing CI, disgust and empathy|7-items-questionnaire including numerical rating scales (NRS) ranging from 0 (no itch/disgust/empathy) to 10 (worst itch/disgust/most empathy imaginable) to rate itch, disgust and empathy they experience when treating the infested families.
15786854|NCT04557644|Other|Saarbrucken Personality questionnaire (SPQ) addressing empathy.|Empathy is additionally assessed by the Saarbrucken Personality Questionnaire (SPQ) ,a 16-item tool.
15786855|NCT04557644|Other|10-items-questionnaire addressing previous dermatological conditions, intensity of itch|10-items-questionnaire (completed by the hospitalised family) regarding demographic information (gender, age, profession), previous dermatological conditions, intensity of itch a.) on the first day of the hospitalisation, b.) when seeing the skin lesions of the other family members c.) when talking about the scabies/itch with the other family members, d.) when seeing other family members scratching themselves, and questions regarding their intensity of disgust of the scabies and empathy for the other family members (0-10 NRS).
15786856|NCT04557644|Other|ItchyQol-questionnaire composed of 22 items addressing itch-related symptoms, functions and emotions|ItchyQol-questionnaire to assess the itch-related quality of life impairment. The ItchyQoL is composed of 22 items addressing itch-related symptoms, functions and emotions.
15786857|NCT04557618|Device|Auricular Vagus Nerve Stimulation|Transcutaneous auricular vagal nerve stimulation
15786858|NCT04557618|Device|Sham Auricular Vagus nerve Stimulation|Transcutaneous auricular vagal nerve ear clip applied without current
15786859|NCT04557605|Other|Progressive cycling exercise test to exhaustion|Progressive step cycling exercise test to exhaustion
15786896|NCT04557358|Other|IER-R (posttraumatic stress)|The instrument measures the presence of posttraumatic stress
15786941|NCT04557059|Drug|Apalutamide|Participants will receive therapeutic dose of apalutamide 240 mg tablets once daily for 180 Days.
15786860|NCT04557579|Procedure|Clear corneal phacoemulsification and IOL implantation|Clear corneal phacoemulsification and IOL implantation were performed by 2 surgeons (Chao-Kai Chang and Hung-Yuan Lin) by using an identical technique to minimize differences in surgically induced aberrations between groups. The surgical process involved topical anesthesia, a 3-step clear corneal incision (2.75 mm) at 180° (temporal in both eyes), a 5.0-mm continuous curvilinear capsulorhexis, phacoemulsification using the stop-and-chop technique, IOL implantation with an injector, IOL centration, and a sutureless incision. The study IOL models include EDOF Symfony IOL (AMO, Santa Ana, CA, USA), bifocal Restor +2.5D IOL (Alcon, Fort Worth, TX, USA), and monofocal Sensar AR40e IOL (AMO, Santa Ana, CA, USA).
15786861|NCT04557566|Behavioral|EBT yoga-based eating disorder course|Yoga for Eating Disorder Recovery online course. This course will be led by certified facilitators via Zoom and offered over the course of four weeks, comprising one two-hour session per week. The course will continue to recruit and enroll participants until sufficient power is reached for the study.
15786862|NCT04557553|Dietary Supplement|Lagenbone|Traditional Chinese medicine herbal formula
15786863|NCT04557540|Behavioral|Lifestyle Therapy|Receive The WORD lifestyle CER weight loss intervention
15786864|NCT04557540|Other|Quality-of-Life Assessment|Ancillary studies
15786865|NCT04557540|Other|Questionnaire Administration|Ancillary studies
15786866|NCT04557540|Other|Short-Term Fasting|Receive Fasting WORD intermittent fasting weight loss intervention
15786867|NCT04557527|Procedure|Pars plana vitrectomy, laser or cryo retinopexy and intraocular gas tamponade|Conventional pars plana vitrectomy procedure is used to treat rhegmatogenous retinal detachment- laser or cryo retinopexy intraocular gas tamponade (SF6, C2F6 or C3F8) are chosen according to the number and size of the causative retinal break(s) and surgeons clinical judgement
15786868|NCT04557527|Device|Suprachoroidal viscobuckle with 2.3% Sodium hyaluronate (Healon 5 Ophthalmic viscoelastic device)|After drainage of subretinal fluid, approximately 0.5 ml of Healon 5 is injected in to the suprachoroidal space underlying the retinal break. Laser retinopexy is applied around the break .
15786869|NCT04557514|Procedure|platelet rich plasma injection in post burn facial scar|"2 spins>>>
~st spin (separate plasma from blood) 2500 for 10 minutes
~nd spin (separate platelet rich part of plasma) 1500 for 10 minutes Taking lower part (platelet rich plasma ) Injection under scar after rigotomy"
15786870|NCT04557514|Procedure|fat injection in post burn facial scar|Anesthesia : general or local Lipoaspirate from abdomen or thigh using adrenaline(1\1000000) + ringer lactate + zylocaine Liposuction by canula no4 Sediment 3 layers : taking mid layer of fat and omit uppermost and lowermost layers Lipoinjection in fan shaped manner 10-20 cc according to site affected by canula no 1 .
15786871|NCT04557501|Diagnostic Test|PSMA PET/CT guided intensification of therapy|PSMA PET/CT prior to treatment.
15786872|NCT04557501|Other|Control Arm|Control - Treatment without PSMA PET/CT
15786873|NCT04557488|Other|Music therapy|Each session will follow a similar structure with a hello song, musical activities, and a goodbye song. The musical activities will vary in each session and will be mixed in later sessions to revisit and practice social skills
15786874|NCT04557488|Behavioral|Behavioral-based social skill training|Each intervention session will follow a standard structure of opening greetings, social activities according to the theme of the session, and a closing activity. The activities and games will vary in each session and will be mixed in later session to revisit and practice social skills.
15786875|NCT04557475|Drug|Aspirin|Two tablets daily with dinner
15786876|NCT04557462|Drug|LNP023|Capsule 200 mg (b.i.d.) taken orally twice a day
15786877|NCT04557449|Drug|PF-07220060|CDK4 inhibitor
15786878|NCT04557449|Combination Product|Letrozole|Endocrine Therapy
15786879|NCT04557449|Combination Product|Fulvestrant|Endocrine Therapy
15786880|NCT04557436|Drug|PBLTT52CAR19|gene therapy
15786881|NCT04557423|Behavioral|Community-Based Education|A previously evaluated educational intervention delivered in community settings. Includes culturally- and linguistically-appropriate materials.
15786882|NCT04557423|Behavioral|Navigation to Screening|Community health educators provide navigation assistance to access clinic-based cervical cancer screening.
15786883|NCT04557423|Behavioral|HPV Self-Sampling|An HPV self-sampling kit will be provided for home-based collection of cervical samples. Samples will be sent for analysis of HPV subtypes.
15786884|NCT04557410|Drug|PolyMVA|"One-half teaspoon of PolyMVA contains the following:
~Daily Value Thiamin (B-1) 23mg 1,533 Riboflavin (B-2) 0.45mg 26 Vitamin B-12 460mcg 7,666 Proprietary Blend 32mg - contains the following ingredients (no FDA value has been established on any of the following): Palladium, Alpha Lipoic Acid, Molybdenum, Rhodium, Ruthenium, Formyl Methionine, N-acetyl Cysteine.
~For each ml of Poly-MVA, the exact dosages are as follows:
~Palladium: 3.97mg Molybdenum: 0.044mg Ruthenium: 0.0014mg Rhodium: 0.014mg Lipoic Acid: 7.68mg Thiamine (B1): 9.26mg Riboflavin (B2): 0.174mg B12: 0.185mg Formyl Methionine: 0.026mg N-Acetyl cysteine: 0.185mg Vitamin A acetate 100 IU
~Other Ingredients: Distilled water, purified water, thiamine hydrochloride, Vitamin B12 as cyanocobalamin."
15786885|NCT04557397|Drug|Fruquintinib|oral VEGFR inhibitor
15786886|NCT04557397|Drug|Itraconazole|a synthetic triazole antifungal agent
15786887|NCT04557397|Drug|Rifampin|a semisynthetic antibiotic derivative of rifamycin SV
15786888|NCT04557384|Drug|Ramucirumab|Administered SC
15786889|NCT04557371|Other|Serum|Participants will topically apply the serum to the face as per normal home use application in place of their current facial serum product.
15786890|NCT04557371|Other|Lotion|Participants will topically apply lotion to the face as per normal home use application in place of their current facial lotion product.
15786891|NCT04557371|Other|Cream|Participants will topically apply cream to the face as per normal home use application in place of their current facial cream product.
15786892|NCT04557358|Other|COVID-19 survey|A questionnaire locally developed to explore access to medical care and to medications, access to communication with their primary rheumatologist, and patients risk perception about COVID-19 disease
15786893|NCT04557358|Other|RAPID-3|The instrument measures function, pain, and patient global estimate of status, with correspond to activity disease
15786894|NCT04557358|Other|WHOQOL-BREF|The instrument measures the patient´s quality of life (4 dimensions: physics, phycological, social, and environment)
15786895|NCT04557358|Other|DASS-21 instrument (depression and anxiety)|The instrument measures the presence of depression and anxiety
15786897|NCT04557345|Diagnostic Test|Determination of cytokines|Subsequently, a blood sample will be taken from which the processing will be as follows: 6 ml of peripheral blood will be taken in tubes with a yellow cap and inert gel and clot retractor, immediately afterward it will be placed on ice, it will be transported to the laboratory where it will be centrifuged at 2500 rpm for 15 minutes at 4 degrees centigrade, immediately afterward 500 µl of serum will be aliquoted and stored at minus 75 ° C until later analysis. The general methodology for sandwich ELISA will be used.
15786898|NCT04557345|Diagnostic Test|Two-dimensional transthoracic echocardiogram|With prior informed consent, a two-dimensional transthoracic echocardiogram will be obtained by an echocardiographer certified by the Mexican Council of Cardiology (CMC) with a Phillips EPIC 7 echocardiography, 2D Arrary 3D Convex (1-6 Mhz) transducer.
15786899|NCT04557332|Behavioral|On the Dot Mobile app|On the Dot is a mobile app to support HIV medication adherence. The mobile app is linked to a clinician portal through which participants can receive adherence support.
15786900|NCT04557319|Biological|GNR-038, 25 МЕ/kg|25 МЕ/kg once per study
15786901|NCT04557319|Biological|GNR-038, 50 МЕ/kg|50 МЕ/kg once per study
15786902|NCT04557319|Biological|GNR-038, 100 МЕ/kg|100 МЕ/kg once per study
15786903|NCT04557306|Biological|CBT101 (2-6 x 10^9 cells), every 2 weeks|CBT101 (2-6 x 10^9 cells), every 4 weeks
15786904|NCT04557306|Biological|CBT101 (2-6 x 10^9 cells), every 4 weeks|CBT101 (2-6 x 10^9 cells), every 4 weeks
15786905|NCT04557293|Device|Continuous Positive Airway Pressure (CPAP) treatment|Treatment of Obstructive sleep apnoea syndrome with CPAP
15786906|NCT04557280|Combination Product|Selatogrel|A single subcutaneous injection of 16 mg.
15786907|NCT04557280|Drug|Selatogrel|A single subcutaneous injection of 16 mg.
15786908|NCT04557267|Drug|low-dose|Dosage 1
15786909|NCT04557267|Drug|Middle-dose|Dosage 2
15786910|NCT04557267|Drug|Higher-dose|Dosage 3
15786911|NCT04557267|Drug|Placebo|Placebo
15786912|NCT04557254|Device|graft|evaluate the early and long-term clinical results, up to 5 years (through follow-up outpatient visits), of a silver and triclosan knitted collagen coated polyester vascular graft (InterGard Synergy), in patients submitted to aortic surgical repair, and compare them with concurrent results of standard Dacron grafts.
15786913|NCT04557241|Behavioral|Brief informational infographic|The primary intervention in this study will be an infographic that is designed to build trust in the scientific process. Infographics are preferable to narratives or text because they center visuals as part of the storytelling process and facilitate cognitive information processing, knowledge absorption, and enhanced persuasion. The study's infographic design will follow best practices in health communication. The message will be simple and jargon free. Visuals will include individuals (scientists), charts, text, and numbers. Attention will be paid to images, color, frames, representation, and composition (e.g., how the elements in the infographic are organized to show their relationship to each other).
15786914|NCT04557241|Behavioral|Placebo control (non-behavioral infographic)|"The comparator in this study will be a control (placebo) infographic that is completely unrelated to science (e.g., about cats), but that is developed using the same communication and graphical style."
15786915|NCT04557228|Dietary Supplement|Placebo|4 weeks of placebo supplements
15786916|NCT04557228|Dietary Supplement|Phosphatidylserine|4 weeks of 400mg phosphatidylserine supplements
15786917|NCT04557215|Drug|Rifaximin|Rifaximin is indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults.
15786918|NCT04557215|Drug|N-acetylcysteine|N-acetylcysteine (NAC) is a clinically approved mucolytic agent.
15786919|NCT04557215|Drug|Placebo|An inactive substance or treatment that looks the same as, and is given in the same way as, an active drug or intervention/treatment being studied.
15786920|NCT04557202|Drug|Tamsulosin Oral Capsule|To assess the efficacy of peri-operative alpha1 blockers on improving the success rate and decreasing complications of non-stented ureteroscopic laser lithotripsy for ureteric stones.
15786921|NCT04557202|Drug|Placebo|Placebo - control group
15786922|NCT04557189|Drug|TAK-951|4 mg TAK-951: SC
15786923|NCT04557189|Drug|Ondansetron|4 mg Ondansetron: IV
15786924|NCT04557189|Drug|Ondansetron Placebo|Ondansetron placebo: IV
15786925|NCT04557189|Drug|TAK-951 Placebo|TAK-951 placebo: SC
15786926|NCT04557176|Device|CRP, point-of-care assay|CRP is a non-specific marker of inflammation whose levels rise in the setting of interleukin 6 (IL-6)-mediated inflammation, such as active TB. In clinical settings, CRP is used to identify patients with systemic inflammation from infection or non-infectious cases. In settings with high TB prevalence, the investigators hypothesize that CRP can be used to accurately screen individuals for active TB (i.e., distinguish individuals with high likelihood of having active TB from those individuals unlikely to have active TB).
15786927|NCT04557163|Drug|TS-142|TS-142 will be given as 1 mg per capsule administered orally with water.
15786928|NCT04557163|Drug|Itraconazole|Itraconazole will given as 50 mg per capsule administered orally with water.
15786929|NCT04557150|Drug|RO7425781|RO7425781 will be administered via IV/SC administration. The MTD/RP2D determined during Part I: Dose Escalation will be administered during Part II: Dose Expansion. RO7425781 will be administered as per the dosing schedule defined in Part I.
15786930|NCT04557137|Drug|Somatostatin analog|120 mg ipstyl every 28 days
15786931|NCT04557124|Behavioral|USS|social cognitive training
15786932|NCT04557124|Behavioral|MovingForward|problem solving training
15786933|NCT04557111|Device|remote monitoring|CIED monitoiring with remote monitoring device
15786934|NCT04557098|Drug|Teclistamab|Teclistamab will be administered SC.
15786935|NCT04557085|Drug|Cenobamate|Cenobamate tablets
15786936|NCT04557085|Drug|Placebo|Matching placebo tablets
15786937|NCT04557072|Drug|Selective alpha-1-antagonist|Patients treated with selective alpha-blockade (prazosin, terazosin, doxazosin)
15786938|NCT04557072|Drug|Non-selective alpha-1-antagonist|Patients treated with non-selective alpha-blockade (phenoxybenzamine)
15786939|NCT04557059|Radiation|Radiotherapy|Participants will receive radiotherapy (RT) with or without optional stereotactic body radiation therapy (SBRT), which will start within 4 weeks after randomization.
15786940|NCT04557059|Drug|LHRHa|Participants will be administered with LHRHa (example, leuprolide, goserelin, triptorelin acetate) as a 3-monthly depot preparation at Day 1 and Day 85 or as a 6-monthly depot preparation at Day 1.
15786942|NCT04557046|Diagnostic Test|Nasal Swab|Collection of one more nasal swabs
15786943|NCT04557046|Diagnostic Test|Nasopharyngeal swab|Collection of one more nasopharyngeal swabs
15786944|NCT04557046|Diagnostic Test|Throat swab|Collection of one more throat swabs
15786945|NCT04557046|Diagnostic Test|Fingerstick|Collection of capillary blood from one or more fingersticks
15786946|NCT04557046|Diagnostic Test|Saliva specimen|Collection of free drool
15786947|NCT04557033|Other|Mindfulness intervention|My Moments® application (app) is a tool used to facilitate expressive art creation in a digital photography media
15786948|NCT04557020|Drug|PD-1 antibody|neoadjuvant: PD-1 inhibitor Toripalimab 240mg combined with neoadjuvant chemotherapy by cis Platinum and gemcitabine every 3 weeks for 3 cycles ; adjuvant: Toripalimab 240mg every 3 weeks for 9 cycles after concurrent chemoradiotherapy
15786949|NCT04557020|Drug|Gemcitabine|neoadjuvant chemotherapy: 1000mg/m2 in day 1 and day 8 and repeats every 3 weeks for 3 cycles
15786950|NCT04557020|Drug|cis Platinum|neoadjuvant chemotherapy: 80mg/m2 in day 1, and repeats every 3 weeks for 3 cycles.
15786951|NCT04557020|Drug|cis Platinum|concurrent chemoradiotherapy: 100mg/m2 in day 1, 22, and 43 during IMRT
15786952|NCT04557020|Radiation|IMRT|70Gy to GTV, 60Gy to CTV1 and 54Gy to CTV2 in 32 to 33 fractions
15786953|NCT04557007|Drug|Pembrolizumab|Drug trough-level will be measured in patients on Pembrolizumab with or without additional chemotherapy in routine care.
15786954|NCT04556994|Other|Phase 1 Cardiac Rehabilitation|"Step 1:Breathing exercises, 3 sets of 10 repetitions. Active upper and lower extremity exercises, 3 sets of 10 repetitions; bed inclined at 45°.
~Step 2:Active exercises as in step 1. Stay in the upright position and perform walking on the spot for three series of 1 min.
~Step 3:Active exercises as in step 2. Ambulation within the inpatient wards (7 min). Transfer to an allocated chair beside the bed (at least 30 min).
~Step 4:Same exercises as in step 3. Ambulation within the inpatient wards (10 min). Transfer to an allocated chair beside the bed (at least 1 h).
~Step 5:Same exercises as in step 4. Ambulation within the inpatient wards (15 min). Transfer to an allocated chair beside the bed (at least 2 h).
~Step 6:Active exercises from the previous day. Ambulation within the inpatient wards (20 min). Step training (3 times continuously, 20 cm standardized step).
~Step 7:Exercises from the previous day. Step training (6 times continuously, 20 cm standardized step)."
15786955|NCT04556994|Other|Phase 1 Cardiac Rehabilitation with Lower Limb Paddling|Step 1 to step 6 of Phase 1 Cardiac Rehabilitation given to the patients along with Lower limb exercise on Paddler lasting 20 min (5-min warm-up, 10 min of low-intensity exercise, and 5-min recovery), 30 rpm ( rotation per minute)
15786956|NCT04556981|Biological|M72/AS01E Mycobacterium tuberculosis vaccine|Participants will receive an intramuscular dose of M72 (10 micrograms of recombinant fusion protein) reconstituted with AS01E (an adjuvant system), on Day 1 and Day 29
15786957|NCT04556981|Biological|Placebo|Participants will receive an intramuscular dose of saline (0.9% NaCl), on Day 1 and Day 29
15786958|NCT04556955|Device|Graston technique|Experimental group included Graston technique :The protocol consist of Longitudinal stroking parallel to muscle fiber for 1min , spin over trigger points for 1 min using knob of instrument and fanning for 2 min.
15786959|NCT04556955|Other|post isometric relaxation|Post Isometric Relaxation, 5 rep , 20% isometric contraction 10 sec , 20 sec of stretch hold beyond resistance barrier
15786960|NCT04556942|Diagnostic Test|Flow Mediated Dilation (FMD) measurement|FMD measurements will be performed by ultrasound using longitudinal images of the brachial artery using a high-frequency (10.0-MHz) ultrasound scanning probe (VividTM E9 with XDeclearTM; GE Healthcare, Chicago, Illinois, USA) proximal to the antecubital fossa. Two-dimensional images, acquired with electrocardiogram gating, will be obtained at baseline with Doppler ultrasound imaging to assess arterial diameter and flow velocity. Reactive hyperemia will then be induced by inflation of a pneumatic tourniquet around the forearm to at least 200 mm Hg (or > 50mmHg above systolic pressure) for 5 minutes. Post-deflation diameter and flow velocity will be monitored continuously from deflation for 210 seconds. To assess endothelial-independent vasodilation maximal brachial artery diameter will be measured continuously for 3 minutes after a single sublingual dose of nitroglycerin (NTG, 0.4 mg).
15786961|NCT04556942|Other|Blood pressure, pulse and blood oxygen saturation measurement|"Blood pressure measurement will be done with a pneumatic tourniquet on the upper arm, after at least 10 minutes rest of the patient.
~Pulse measurement and oxygen saturation measurement will be done using a finger pulseoximeter, after at least 10 minutes rest of the patient."
15786962|NCT04556942|Other|ST George Respiratory Questionnaire|The is a validated and standardized Questionnaire designed to measure health impairment in COPD patients
15786963|NCT04556942|Other|Physical activity level (PAL) measurement|PAL will be assessed by the number of steps and kilometers per day using a triaxial accelerometer of a multisensory activity monitor (Fitbit Alta HR; Fitbit Inc., San Francisco, CA, USA). The device is worn like a watch on the wrist. The device is worn always, except while showering or swimming.
15786964|NCT04556942|Biological|Withdrawal of a blood sample|5ml of blood will be withdrawn and preserved after centrifugation at -50 degrees celsius for later analysis at a yet unknown time
15786965|NCT04556942|Procedure|Immediate Bronchoscopic Lung Volume Reduction|Bronchoscopic Lung Volume Reduction by using endobronchial valve placement Within 2 weeks after T0
15786966|NCT04556942|Procedure|Delayed Bronchoscopic Lung Volume Reduction|Bronchoscopic Lung Volume Reduction by using endobronchial valve placement Within 6-8 weeks after T0 and 3-4 days after T1
15786967|NCT04556929|Diagnostic Test|Intra-operative imaging of 5-ALA fluorescence using ultra-high sensitivity camera|An ultra-high sensitivity camera attached to the side arm of the operative microscope will be used to take images of the anterior, posterior, lateral and inferior walls of the resection cavity on completion of tumour resection.
15786968|NCT04556929|Diagnostic Test|Intra-operative imaging of 5-ALA fluorescence using in-built operative microscope camera|In-built camera of the operative microscope will be used to take images of the anterior, posterior, lateral and inferior walls of the resection cavity on completion of tumour resection.
15786969|NCT04556929|Diagnostic Test|Biopsies|Following image capture, biopsies (approx 5x5x5mm size) will be taken from regions of the anterior, posterior, lateral and inferior walls of the resection cavity corresponding to the imaged areas.
15787010|NCT04556695|Device|Accelerometer study|Consenting participants will be asked to wear an accelerometer on the lateral aspect of the middle of the right thigh (over the midpoint of the iliotibial band), continuously over a seven-day period.
15786970|NCT04556916|Diagnostic Test|Blood sample|"Per patient 49 ml of peripheral blood sample :
~21ml divided into 3 TransFix or EDTA 7ml tubes will be sent to Hamburg for subsequent CTCapture analysis;
~28ml divided into 4 EDTA 7ml tubes will be sent to Montpellier for subsequent EPIDROP analysis (21 ml), PHI analysis (7 ml) and plasma isolation."
15786971|NCT04556903|Combination Product|Bilateral Arm Training|First component of mCIMT will comprise one hour activity and a rest period of five minute given between each ten minutes of task practice. These activities will base on activities of daily living (ADL'S) and I
15786972|NCT04556903|Combination Product|modified constrained induce movement therapy|"BAT involves in four sessions, each session involve repetitive practice of bilateral tasks for one hour and a rest period of 5 minutes. The tasks are:
~Block placement- 10minutes
~Peg targeting- 10 minutes
~Peg inversion-10miutes
~Transferring objects- 10minutes"
15786973|NCT04556890|Device|Active rTMS/Active iTBS DFPLC/Sham Pain M1|Active rTMS treatment for depression (600 pulses of active intermittent theta burst (iTBS) administrated at 120% MT to the left DLPFC) and sham treatment for pain at M1
15786974|NCT04556890|Device|Sham rTMS/ Active iTBS Pain|Sham rTMS for depression and active iTBS for pain (600 pulses of iTBS followed by 1500 pulses of 10 Hz rTMS, both at 120% MT
15786975|NCT04556890|Device|Active rTMS/Active iTBS|Active rTMS treatment for both, depression and pain (600 pulses of iTBS to left DLPFC followed by 600 iTBS + 1500 pulses of 10 Hz to M1
15786976|NCT04556877|Procedure|Intraabdominal pressure and optic nerve diameters|Measuring Intraabdominal pressure with a Foley cathater and measuring optic nerve diameters with a USG
15786977|NCT04556851|Drug|HSK7653 10 mg Q2W|HSK7653 5 mg (2 tablets) and placebo 25 mg (1 tablet), Q2W, oral, week 1 to week 24; HSK7653 25 mg (1 tablet), Q2W, oral, week 25 to week 52.
15786978|NCT04556851|Drug|HSK7653 25 mg Q2W|HSK7653 25 mg (1 tablet) and placebo 5 mg (2 tablets), Q2W, oral, week 1 to week 24; HSK7653 25 mg (1 tablet), Q2W, oral, week 25 to week 52.
15786979|NCT04556851|Drug|Placebo|Placebo 25 mg (1 tablet) and placebo 5 mg (2 tablets), Q2W, oral, week 1 to week 24; HSK7653 25 mg (1 tablet), Q2W, oral, week 25 to week 52.
15786983|NCT04556825|Drug|PRP|After the arthroscopic operation was completed, a local PRP injection was performed
15786984|NCT04556825|Drug|normal saline|After the arthroscopic operation was completed, a local normal saline injection was performed
15786985|NCT04556812|Procedure|Four-in-one procedure|"four-in-one surgical technique centered on tibial tuberosity osteotomy and proximal displacement"
15786986|NCT04556812|Procedure|soft-tissue surgery|traditional soft-tissue surgery
15786987|NCT04556799|Procedure|computer-assisted surgery|derotation osteotomy with the aid of 3D osteotomy template and computer-assisted simulated surgery
15786988|NCT04556799|Procedure|traditional osteotomy|traditional osteotomy without the aid of 3D osteotomy template
15786989|NCT04556786|Behavioral|Transitions of care|The intervention was a pharmacist-led transitions of care program that include medication reconciliation, daily schedule for medication taking and medical condition monitoring, and follow-up phone calls from a pharmacist at 60- and 90-day post-discharge in addition to the usual care.
15786990|NCT04556773|Drug|Trastuzumab deruxtecan|T-DXd: administered as an IV infusion
15786991|NCT04556773|Drug|Durvalumab|Durvalumab: administered as an IV infusion
15786992|NCT04556773|Drug|Paclitaxel|Paclitaxel: administered as an IV infusion
15786993|NCT04556773|Drug|Capivasertib|Capivasertib: administered orally
15786994|NCT04556773|Drug|Anastrozole|Anastrozole: administered orally
15786995|NCT04556773|Drug|Fulvestrant|Fulvestrant: administered as an IM injection
15786996|NCT04556773|Drug|Capecitabine|Capecitabine: administered orally
15786997|NCT04556760|Drug|AZD9567|Participants will receive 72 mg/day (oral suspension) of AZD9567 for 3 consecutive days of each treatment period in Cohort 1 and 40 mg/day for 3 consecutive days of each treatment period in Cohort 2.
15786998|NCT04556760|Drug|Prednisolone|Participants will receive 40 mg/day of prednisolone for 3 consecutive days of each treatment period in Cohort 1, 20 mg/day of prednisolone for 3 consecutive days of each treatment period in Cohort 2, and 5 mg/day prednisolone for 3 consecutive days of each treatment period in Cohort 3.
15786999|NCT04556760|Other|Placebo|Participants will receive placebo for 3 consecutive days of each treatment period in Cohort 3.
15787000|NCT04556747|Other|VR - Distraction|Participants will be instructed to use any application.
15787001|NCT04556747|Other|VR - Biofeedback|Participants will be instructed to use the Mindful Aurora application.
15787002|NCT04556734|Drug|Etrasimod|Etrasimod 2 mg tablet by mouth, once daily
15787003|NCT04556734|Drug|Etrasimod|Etrasimod 3 mg (1 mg and 2 mg tablets) by mouth, once daily
15787004|NCT04556734|Drug|Placebo|Etrasimod matching placebo tablet by mouth, once daily
15787005|NCT04556721|Drug|Sugammadex|On the day of surgery, after the establishment of general anesthesia, patients will be paralyzed via rocuronium. At the cessation of the case, an appropriate dose of Sugammadex will be utilized to reverse the rocuronium neuromuscular blockade.
15787006|NCT04556708|Other|salin irrigation|Non-surgical periodontal treatment (SRP and oral hygiene instructions) was performed and subgingival irrigation with saline was performed. Gingival crevicular fluid (GCF) samples were taken for vascular endothelial growth factor (VEGF) and insulin-like growth factor-1 (IGF-1) examination.
15787007|NCT04556708|Other|ozonated water irrigation|Non-surgical periodontal treatment (SRP and oral hygiene instructions) was performed and subgingival irrigation with ozonated water was performed. Gingival crevicular fluid (GCF) samples were taken for vascular endothelial growth factor (VEGF) and insulin-like growth factor-1 (IGF-1) examination.
15787008|NCT04556708|Other|chlorhexidine irrigation|Non-surgical periodontal treatment (SRP and oral hygiene instructions) was performed and subgingival irrigation with 0.12% chlorhexidine digluconate was performed. Gingival crevicular fluid (GCF) samples were taken for vascular endothelial growth factor (VEGF) and insulin-like growth factor-1 (IGF-1) examination.
15787009|NCT04556695|Other|Questionnaire survey|Online questionnaire, based on the International Sedentary Assessment Tool (ISAT)
15787048|NCT04556383|Drug|Placebo|Placebo
15787049|NCT04556370|Drug|Normal saline|Normal saline infusion simultaneous with subarachnoid block
15787011|NCT04556695|Other|Semi-structured interview study|Semi-structured interviews will take place via telephone or webcam. Participants will be given feedback regarding their accelerometer data relating to their levels of physical activity and sedentary behaviour. Questions will examine participants' thoughts and opinions regarding sedentary behaviour and physical activity in the General Practice setting. Further questions will explore participants' experiences of wearing accelerometers, their knowledge of and attitudes towards physical activity and sedentary behaviour and their thoughts or suggestions on interventions to reduce sedentary behaviour among GPs and GPSTs.
15787014|NCT04556669|Biological|Autologous aPD-L1 armored anti-CD22 CAR T cells|Autologous aPD-L1 armored CD22-targeting CAR T cells
15787017|NCT04556643|Other|Breathing exercises|The main components of breathing exercises during training will be as follows (A) First, fill your stomach and then your lungs with air while breathing in; (B) Feel the expansion in the stomach; (C) Make sure the muscles from your stomach to your knee are relaxed, as if you are urinating while breathing out; (D) When there is pain, perform deep abdominal breathing exercises, and take a deep breath in and hold as much as you can; (E) Try to push the baby downward; (F) You can do it by holding your breath or breathing out quite slowly from your mouth; (G) The most important point in this stage is that you should not fill up the stomach with air, and you should push downward to deliver the baby; (H) You should continue the pushing until the pain is relieved
15787018|NCT04556617|Drug|PLX2853|PLX2853 tablets
15787019|NCT04556617|Drug|Olaparib|Olaparib tablets
15787020|NCT04556617|Drug|Abiraterone acetate|Abiraterone acetate tablets
15787021|NCT04556617|Drug|Prednisone|Prednisone (or equivalent) tablets
15787022|NCT04556604|Behavioral|Educational meetings and visual prompts|Information was disseminated to trainees via informal meeting or dedicated audit meetings with the aid of visual prompts
15787023|NCT04556591|Behavioral|Just-in-time adaptive intervention (JITAI)|JITAI is an emerging intervention that incorporates passive mobile sensor data feedback (sleep and activity [step] data from a Fitbit ®), and real-time self-reporting of HRQOL via a study specific app called CareQOL to provide personalized feedback via app alert.
15787024|NCT04556591|Behavioral|Control|Participants will wear the Fitbit® and provide daily reports of HRQOL over a three-month (90 day) period
15787025|NCT04556578|Procedure|High-flow extracorporeal CO2 removal|Applying of a CO2 removal using an extracorporeal circulation with a flow of 2-3.5L/min in order to reduce the aggression induced by the mechanical ventilation.
15787026|NCT04556552|Device|Non invasive VN stimulation (nVNS)|"Stimulation of vagus nerve with active device. Participants will be administered nVNS using the electroCore GammaCore-S non-invasive VNS device. The intensity of the stimulus will be adjusted by the user, to the maximum tolerable level to ensure nVNS without causing excessive pain, the burst frequency to 5 kHz, and the envelope frequency to 25 Hz.
~The duration of delivery will be 2 minutes, and the beginning will coincide with initiation of acquisition of the HR-PET scan which will be 90 seconds in duration; following an additional 8 minutes, a second VNS delivery will be administered, in conjunction with which another scan will be obtained."
15787027|NCT04556552|Drug|Oxygen (15-O) Water|Injection of radiolabelled water. H2[15-O] is a radioactive material. Each patient will have eight H2[15-O] blood flow scans. For each O-15 water scan 20 mCi of H2[15O] will be injected as an intravenous bolus.
15787028|NCT04556552|Device|Sham Stimulation|"Sham stimulation of vagus during opioid cue exposure. Each subject in the SHAM group will undergo the action of administering the intervention, but the device will be programmed such that the stimulation will not activate the vagus nerve."
15787029|NCT04556539|Drug|SC10914|400mg TID, oral admination on fasting condition
15787032|NCT04556513|Other|Paraclinical examination|Respiratory functional tests
15787033|NCT04556513|Other|Clinical Examination|Clinical Examination
15787034|NCT04556513|Other|Semi-directive interview|By phone
15787035|NCT04556513|Other|quality of life questionnaires|SF36, VSRQ, IESR, HADS
15787036|NCT04556500|Other|investigating the psychometric properties of Turkish Affordance in the Home Environment for Motor Development-Toddler (AHEMD-T)|AHEMD-T will apply to parents who have 18-42 months child/children
15787037|NCT04556487|Other|evaluation|we will evaluate the home environment of the children asking by parents
15787038|NCT04556461|Drug|Tralokinumab|2 x 300 mg Tralokinumab s.c. loading dose followed by 8 x 300 mg every 2 weeks (Q2W)
15787039|NCT04556448|Other|Aligners|Clear aligners
15787040|NCT04556448|Other|Clear braces|Clear braces
15787041|NCT04556422|Other|Aerobic exercise|15 minutes of aerobic exercise using stationary bicycle
15787042|NCT04556422|Other|Sauna bathing|Passive heat exposure
15787043|NCT04556409|Device|low intensity pulsed ultrasound plus static abdominal and pelvic floor exercises.|Ultrasonic irradiation was employed with parameters of current use in clinical practice, including lower potency (0.16 W/cm2), which is more adequate for stimulation of nerve regeneration, according to results obtained in investigations in which the irradiation was applied at the lesion site 32, 33.
15787044|NCT04556409|Device|low level LASER plus static abdominal and pelvic floor exercises.|Application of laser irradiation (Ga-As laser) in the site of the anastomosis inhibits the degeneration process, accelerate remyelination, and nerve function recovery 27, 28
15787045|NCT04556409|Other|static abdominal and pelvic floor exercises only.|static abdominal and pelvic floor exercises., 3 times/week for 4 weeks.
15787046|NCT04556396|Diagnostic Test|Cone beam CT|On-table CT scan in the operating room to determine residual kidney stone burden at end of procedure
15787047|NCT04556383|Drug|GB004|GB004, a small molecule hypoxia inducible factor 1 alpha (HIF-1α) stabilizer
15787050|NCT04556370|Drug|Norepinephrine|Different infusion dose of norepinephrine simultaneous with subarachnoid block
15787051|NCT04556357|Drug|Phenylephrine|A maintenance dose of phenylephrine (0.625 μg/kg/min) infusion simultaneous with subarachnoid block
15787052|NCT04556357|Drug|Norepinephrine|A maintenance dose of norepinephrine (0.05 μg/kg/min) infusion simultaneous with subarachnoid block
15787053|NCT04556344|Behavioral|Emotional skills|3 sessions of 1,5 hour each. The first session can be face to face or over the phone, the two last ones will be held over the phone.
15787054|NCT04556344|Behavioral|Short free talk and relaxation|3 sessions of 1,5 hour each. The first session can be face to face or over the phone, the two last ones will be held over the phone.
15787055|NCT04556331|Behavioral|Parenting programme (cognitive behavioural) aimed at reducing generational transmission of anxiety|'Psychoeducation' (psychologically informed information about the topic of transmitting anxiety) and cognitive-behavioural strategies aimed at reducing the transmission of anxiety from parent to young child. These will be shared with a group of maximum 8 remotely delivered, in a didactic format.
15787056|NCT04556318|Device|Ion Mobility Spectrometry (IMS)|Two breathing gas samples will be taken from each study participant using ion mobility spectrometry with an ultrasound-based spirometer. The total sampling time is 1 minute (at least 5-7 breath takes) following an analysis time of 5-12 minutes.
15787057|NCT04556305|Behavioral|Mind|See arm description.
15787058|NCT04556305|Behavioral|Move|See arm description.
15787059|NCT04556292|Drug|SC10914|SC10914 400mg tid
15787060|NCT04556279|Procedure|adrenalectomy|Surgical removal of an adrenal gland containing an aldosterone secreting adenoma.
15787061|NCT04556279|Drug|Aldosterone Antagonist|Medical treatment of primary hyperaldosteronism.
15787062|NCT04556266|Biological|CAR T-Cell Infusion|Dose Level -1: 1 x 10^4 cells/kg Dose Level 1: 1 x 10^5 cells/kg Dose Level 2: 2 x 10^5 cells/kg Dose Level 3: 4 x 10^5 cells/kg
15787063|NCT04556253|Drug|AK104|Subjects will receive AK104 by intravenous administration.
15787064|NCT04556240|Device|VitalConnect Platform|The VitalConnect Platform is a wireless remote monitoring system intended for use by healthcare professionals for continuous collection of physiological and irregular heart rhythm data in home and healthcare settings. This includes heart rate, electrocardiogram (ECG), heart rate variability (R-R interval), breathing rate, arrhythmia detection, body temperature, skin temperature, activity (including step count), and posture (body position relative to gravity including fall). Data is transmitted wirelessly to a central location where it is stored for analysis. The VitalConnect Platform can be configured by authorized persons to notify healthcare professionals when physiological data falls outside selected parameters
15787065|NCT04556227|Behavioral|Simultaneous Cycle/Cognitive Training|Two weeks after discharge from the hospital the intervention group will complete recumbent cycle for 1 hour, 2x/wk. for 12 weeks (24 sessions). 10-minute cycle warm-up, 40-minute simultaneous cycling and cognitive training, 10-minute cool down. Cycling based on provider prescription and progression of physical recovery. Cognitive training program from Posit Science, Brain HQ (TM) progressive level of difficulty. Total duration of 60 minutes.
15787066|NCT04556214|Procedure|Liver Transplant|Liver Transplant
15787067|NCT04556201|Device|SOLTIVE™ Premium SuperPulsed Laser Fiber System|SOLTIVE™ SuperPulsed Laser Fiber System and SOLTIVE™ Laser Fibers for single-use only
15787068|NCT04556188|Procedure|Cardiac surgery|
15787069|NCT04556175|Behavioral|Oral Health|Motivational interviewing for mothers pre-and postpartum; fluoride varnish for infants/children.
15787070|NCT04556175|Behavioral|Healthy Lifestyle|Didactic maternal and child health educational sessions for mothers pre-and postpartum; fluoride varnish for infants/children.
15787071|NCT04556162|Diagnostic Test|fractional sodium excretion|fractional sodium excretion will be compared to urinary sodium/creatinin, sodium/potassium ratio's and sodium concentration.
15787072|NCT04556162|Other|risk subgroups|subgroup analysis will be performed to identify the patient groups at risk for sodium depletion
15787073|NCT04556149|Device|imPulse™ Una e-stethoscope|The imPulse™ System is an every/anywhere-point-of-care cardiopulmonary functional state assessment platform designed to capture normal and abnormal, audible and inaudible cardiopulmonary sounds, rhythms and patterns, via a real-time, intelligent, full-spectrum phonocardiogram obtained from direct to skin coupling or through a layer of clothing.
15787074|NCT04556149|Device|Philips Lumify Ultrasound System|Point-of-care ultrasound
15787075|NCT04556136|Device|Standing Phototherapy Kiosk|Benesol is a freestanding booth designed to deliver a small amount of targeted UVB with an interactive user interface and cloud-based software that enables patient self-care. The treatment delivery mechanism uses a metal halide lamp with a series of filters and a lens to optimize full-body exposure to the narrow spectrum (293 - 303nm) of UVB light most efficient at producing vitamin D3. The device uses software to identify patients, establish individual skin types and determine dosage. The system has been designed to manage exposure time and frequency and deliver 60% of a skin-type-adjusted Minimal Erythemal Dose (MED). The expected result for users is a rise in blood levels of 25(OH)D via the endogenous pathway.
15787076|NCT04556136|Dietary Supplement|D3 Oral supplement|Each subject assigned to the comparison group was instructed to take one vitamin D3 pill, dispensed by the research pharmacist, each day with a meal for 70 days. Subjects were instructed not to take any additional vitamin D supplementation during the study period. This dosing frequency is consistent with the RDA recommendation. Subjects were instructed to bring their pill bottle with them when returning for their follow up appointment.
15787077|NCT04556123|Other|Measurement of the hydration state and decongestive treatment according to bioimpedance spectroscopy|"The measurements will be performed in each center by a reference physician or nurse, using a portable whole body bioimpedance spectroscopy device, BCM (Fresenius Medical Care).
~The electrodes will be attached to one hand and one foot on the ipsilateral side, after the patient has been in the supine position for at least 5 minutes."
15787078|NCT04556123|Other|Measurement of the hydration state and decongestive treatment according to clinical judgement alone|Clinical judgement will be performed in each center by a reference physician or nurse
15787100|NCT04555954|Other|surveys and questionnaires|The study practised the physical activity levels of healthy adults aged 18-65 years in Turkey during the novel type of coronavirus pandemic by the International Physical Activity Questionnaires-Short Form (IPAQ-SF). Communication with the participants of the study was conducted via online survey software (Google Forms) and social media communication application (WhatsApp).
15787079|NCT04556110|Drug|Perindopril tert-Butylamine tablets （ Produced by Haisco）|The trial was divided into four cycles, between of each cycle with a 14-day wash-out period.In the first cycle，subjects in experimental group took the test preparation Perindopril tert-butylamine after meal, and subjects in control group took the reference preparation ACERTIL® after meal; In the second cycle subjects in experimental group took the reference preparation ACERTIL® after meal , the trial preparation perindopril tert-butylamine was taken orally after meals for the subjects in control group ; the order of taking the medicines for the subjects in the third cycle was the same as that in the first cycle, and the taking order of the subjects in the fourth cycle was the same as that in the second cycle. A single oral administration was used for the four cycles, and the dose was 4 mg.
15787080|NCT04556110|Drug|Perindopril tert-Butylamine tablets（ACERTIL®）|The trial was divided into four cycles, between of each cycle with a 14-day wash-out period.In the first cycle，subjects in experimental group took the test preparation Perindopril tert-butylamine after meal, and subjects in control group took the reference preparation ACERTIL® after meal; In the second cycle subjects in experimental group took the reference preparation ACERTIL® after meal , the trial preparation perindopril tert-butylamine was taken orally after meals for the subjects in control group ; the order of taking the medicines for the subjects in the third cycle was the same as that in the first cycle, and the taking order of the subjects in the fourth cycle was the same as that in the second cycle. A single oral administration was used for the four cycles, and the dose was 4 mg.
15787081|NCT04556097|Behavioral|Care Ecosystem|"The Care Ecosystem model uses a telephone-based intervention to support persons with dementia and their care partners, screening for common dementia-related problems and providing modular standardized support protocols and caregiver education. Specially trained health care navigators systematically identify needs and address health status, advance care planning, medication management and management of challenging behaviors. Health care navigators receive backup support from a nurse, social worker, dementia specialist, and pharmacist, and maintain close communication with the primary care provider of the persons with dementia.
~This Care Ecosystem model will be adapted to augment the dementia care provided by experienced Integrated Care Management Program nurse care managers engaged in the care of high-risk, high-cost patients in a large health system."
15787082|NCT04556084|Drug|Blinatumomab|"Blinatumomab will be given as a 28-day continuous infusion with 14-days in between Cycle 1 and Cycle 2 as per the package insert and FDA approved labeling.
~Patient weight greater than or equal to 45kg will receive 28 mcg/day
~Patient weight less than 45kg will receive 15 mcg/m2/day"
15787083|NCT04556071|Drug|Niraparib|Niraparib will be administered orally once a day continuously throughout each 21-days cycle. The initial dose will be based on the participant's basal body weight or platelet count. Participants with basal body weight≥77 kg and basal platelet count of≥150,000/microliter (μL) will take 300 mg daily. While participants with basal body weight<77 kg and/or basal platelet count <150,000/μL will take 200 mg daily.
15787084|NCT04556071|Drug|Bevacizumab|The dose of Bevacizumab will be 15 mg/kg that administered via a 30-minute intravenous infusion on day 1 of every 21-day cycle in the absence of progressive disease (PD), unacceptable toxicity, participant withdrawal, Investigator's decision, or death.
15787085|NCT04556058|Drug|Perindopril tert-Butylamine tablets （ Produced by Haisco）|The trial is divided into two cycles, between of two cycle with a 14-day wash-out period. In the first cycle, the subjects in experimental group took the test preparation perindopril tert-butylamine tablets on an empty stomach, and the subjects in control group took the reference preparation ACERTIL® on an empty stomach. The subjects of the two groups exchanged on the 15th day after the first administration take medicine. A single oral administration was used for both cycles, and the dose was 4 mg.
15787086|NCT04556058|Drug|Perindopril tert-Butylamine tablets（ACERTIL®）|The trial is divided into two cycles, between of two cycle with a 14-day wash-out period. In the first cycle, the subjects in experimental group took the test preparation perindopril tert-butylamine tablets on an empty stomach, and the subjects in control group took the reference preparation ACERTIL® on an empty stomach. The subjects of the two groups exchanged on the 15th day after the first administration take medicine. A single oral administration was used for both cycles, and the dose was 4 mg.
15787087|NCT04556045|Behavioral|Exercise therapy + radiation therapy|The exercise intervention will last 6 weeks and consist of 5-times weekly resistance training intervention combined with aerobic exercise.
15787088|NCT04556045|Radiation|Radiation therapy|Participant will receive radiation therapy.
15787089|NCT04556032|Dietary Supplement|L-Ergothioneine 10 mg/d|L-Ergothioneine 10 mg/d
15787090|NCT04556032|Dietary Supplement|L-Ergothioneine 25 mg/d|L-Ergothioneine 25 mg/d
15787091|NCT04556032|Other|Placebo|0 mg/d L-Ergothioneine
15787092|NCT04556019|Procedure|Hepatobiliopancreatic surgery|Different surgical techniques tailored to each patient´s pathology
15787093|NCT04556006|Other|Patient education|"The data collection process of the study was carried out in two stages using data collection tools.
~First stage: Personal Information Form and Compliance Questionnaire were applied to all patients in both groups. After anthropometric measurements, FR score was determined. The data collection forms were filled with the patients using face-to-face interview technique. The data collection process lasted for approximately 10-15 minutes. After the data collection, the patients in the intervention group were trained. No training was given to the patients in the control group but they received a Coronary Artery Disease Management Guide.
~Second stage: 12 weeks after the first interview, the patients were interviewed again face-to-face interview technique and the forms and measurements applied initially were repeated."
15787094|NCT04555993|Procedure|lower abdominal surgery|Patients will undergo lower abdominal surgery under general anesthesia.
15787095|NCT04555993|Other|Erector spinae plane block|patients will receive erector spinae plane block using 20 mL levobupivacaine (0.25%).
15787096|NCT04555993|Other|Transversus abdominis plane block|patients will receive transversus abdominis plane block using 20 mL levobupivacaine (0.25%).
15787097|NCT04555980|Device|Warming patch|The warming patch can increase the temp of injection site, result in a blood vessels to dilate, which may have some contribute to decreasing injection pain.
15787098|NCT04555980|Device|Cotton patch|The Cotton patch will cover the injection site as placebo. It dose not have the function of heating comparing to Warming patch.
15787099|NCT04555967|Device|SAPIEN 3 Ultra System|Transcatheter aortic valve implantation
15787101|NCT04555941|Device|intermittent theta burst stimulation|active or Sham iTBS will be given to the AD/MCI patient
15787102|NCT04555928|Other|No intervention|This is a prospective cohort (survey) study. It has no intervention.
15787103|NCT04555915|Other|Monitoring of cerebral oxygenation|Modify cardio-respiratory support to avoid cerebral hypoxia
15787104|NCT04555902|Behavioral|Postcard|The postcard includes appeals to get annual mammograms and provides information for ordering a mammogram.
15787105|NCT04555902|Behavioral|Small Gift|Pink socks are included in the mailer. The gift increases salience of the mailer and it potentially promotes reciprocation from the recipient in the form of ordering a mammogram.
15787106|NCT04555902|Behavioral|Loss Frame and Fear Appeals|The postcard is enhanced with language that frames the situation in terms of losses. It also uses fear appeals by stating the risks of breast cancer, while also stating that a mammogram screening is an accessible way to address those risks.
15787107|NCT04555889|Device|lung recruitment maneuver (LRM) with DrageerVN500|interventions involving device that may help to gradually lung development
15787108|NCT04555876|Device|high tone external muscle stimulation- stationary bicycle|high-tone external muscle stimulation (HTEMS), with Frequencies continuously will be scanned from 4096 Hz to 31768 Hz, allowing for a much higher power of up to 5000 mW to be introduced 3 times per week, for 10 weeks
15787109|NCT04555863|Device|haMSter smartphone app|the app tracks patient reported outcomes
15787110|NCT04555850|Drug|Recombinant Human Thymosin β4|Healthy subjects , were given a dose of rh-Tβ4 for ten consecutive days.
15787111|NCT04555850|Other|Placebo|3 cohorts, with 6 healthy subjects , were given a dose of Placebo for ten consecutive days. Cohorts received ascending doses of either 0.5,2.0 or 5.0 ug/kg .
15787112|NCT04555837|Drug|Alisertib|Given PO
15787113|NCT04555837|Biological|Pembrolizumab|Given IV
15787114|NCT04555824|Drug|Recombinant Human Thymosin β4|Healthy subjects , were given a single intravenous dose of rh-Tβ4 in Day1.
15787115|NCT04555824|Other|Placebo|Five cohorts, with 10 healthy subjects , were given a single intravenous dose of Placebo. Cohorts received ascending doses of either 0.5, 2,5,12.5 or 25 ug/kg in Day1.
15787116|NCT04555811|Drug|FT596|FT596 is given 2-3 days after rituximab; however, it may be delayed for up to 7 days until all rituximab infusion related toxicities resolve to ≤Grade 1.
15787117|NCT04555811|Drug|Rituximab|Rituximab 375 mg/m^2 is administered as an IV infusion per institutional standard of care and package insert on 2-3 days (48 to 72 hours) prior to the FT596 infusion
15787118|NCT04555798|Drug|Meropenem Injection|patients of both groups given meropenam 1 gram every 8 hours till we collect the sputum culture
15787119|NCT04555798|Device|A-V ECMO|Only patients of group B connected to A-V ECMO for two weeks
15787120|NCT04555785|Drug|Wilate|Wilate ® will be given with platelets in cases of severe bleeding. Wilate ® is a 1:1 balanced mixture of von Willebrand Factor (2'000 IU) and Coagulation factor VIII (2'000 IU) and as such has anti-haemorrhagic potential. It is extracted from plasma, freeze-dried and virus-inactivated.
15787121|NCT04555785|Other|Placebo|Empty placebo will be given with platelets in cases of severe bleeding.
15787122|NCT04555772|Other|factors evaluation|They investigated mortality and morbidity in patients who underwent emergency operation within 24 hours after traumatic brain injury.
15787123|NCT04555759|Other|2-minute walk test|The patients will do a 2-minute walk test, using their walking aids or braces
15787124|NCT04555746|Behavioral|Physical activity|Four PA experts (researchers (PhD) within the field of PA and health in children, and physical education teachers) in collaboration with two members of the ECEC staff and two members of the municipality health department (paediatric physiotherapists) developed a frame for the intervention based on COP elements to be further developed, concretized and implemented by the staff. The intervention lasted for four months and contained the following components (Table 1): pre-meetings and follow up meetings in each ECEC institution; start up seminar and two follow up courses with all the staff members; ongoing planning and collective reflections practice in the ECEC institutions; Facebook group; and an equipment-package.
15787125|NCT04555733|Drug|Lemborexant|Lemborexant oral tablets.
15787126|NCT04555720|Behavioral|Interdisciplinary Visit|If assigned to the interdisciplinary group, participants will see social work, physical therapy, occupational therapy, speech therapy, and pharmacy in a scheduled rotation for about 45 minutes each. After these evaluations, the team meets with the participants doctor for a discussion of treatment. After this meeting, the participants doctor will meet to discuss a treatment plan and make recommendations.
15787127|NCT04555707|Drug|Apremilast 30mg|30mg PO BID started within 10 days of baseline
15787128|NCT04555707|Drug|calcipotriene and betamethasone dipropionate|1 application daily starting at baseline and continuing for 4 weeks; those achieving clear or almost clear PGA at week 4 will continue application twice weekly on Monday and Thursday in combination with Otezla. Enstilar application is discontinued at week 16 and study participation continues until week 20.
15787129|NCT04555694|Drug|Cyclosporin|Used to increase tear production in patients who have dry eye caused by inflammation
15787130|NCT04555694|Drug|Loteprednol Etabonate|Used to treat inflammation of the eye
15787131|NCT04555694|Drug|Dexamethasone Ophthalmic 0.4 Mg Ophthalmic Insert|Used to treat inflammation of the eye
15787132|NCT04555681|Diagnostic Test|Collection of subgingival dental plaque|Identification and quantification using q-PCR of the 21 bacteria most frequently found in the dental plaque (including the periopathogenic bacteria) and Candida albicans.
15787133|NCT04555668|Other|Global Postural Reeducation Program|Global Postural Reeducation Program with hamstring stretch The lying posture with flexion of the legs aimed to stretch the posterior chain (upper trapezius, levator scapulae, sub occipital, erector spinae, gluteus maximus, ischio-tibial, triceps surae, and foot intrinsic muscles). The initial position will lying with the hip flexed and progression consisted of increasing hip flexion, knee extension, and dorsiflexion of the ankle All above exercises will be given and to be held for 15 minutes each. 40 min/session, 3 times/week for 6 weeks
15787134|NCT04555668|Other|Hamstring Stretch Program|Hamstring Stretch Program 3 times for 30 seconds hold, subjects rested for 15 seconds between stretches. Knee -flexor eccentric training to prevent hamstring muscle strain 10-15 rep 40 min/session, 3 times/week for 6 weeks
15787135|NCT04555655|Dietary Supplement|Chicken extract supplement|70ml of chicken extract supplement to be consumed daily in the morning before meals for 2 years.
15787136|NCT04555655|Dietary Supplement|Peptide Supplement|70ml of Peptide Supplement (670mg) to be consumed daily in the morning before meals for 2 years.
15787137|NCT04555655|Other|Placebo|70ml of placebo (caesinate) to be consumed daily in the morning before meals for 2 years.
15787138|NCT04555629|Other|Advanced Cognitive Stimulation Therapy Hong Kong|A modified version of Cognitive Stimulation Therapy for people with moderate to severe dementia translated and culturally adapted for the Hong Kong Chinese population.
15787139|NCT04555616|Behavioral|Standard Environmental Design|Participants' caregivers will receive set script of physical environmental modifications (i.e., declutter living space, reduce background noise, increase natural light), and social environment training script will include caregiving techniques: training for calming demeanor (emotional contagion), needs-driven care to decrease behavioral disruption, and accepting and accommodating approach to behavioral disruption. A pre-selected sensory stimulation kit will be provided to each participants' caregiver for administration throughout the day.
15787140|NCT04555616|Behavioral|Individual Environmental Design|Participants' caregivers will receive set script of physical environmental modifications and social environment training script in a standard protocol. Following initial assessments, individualized sensory stimulation kits will be developed using subjects' preferred sensory stimuli (as determined by the Adult Sensory Profile assessment and informant report) and will be provided via caregiver administration throughout the day to promote maintained behavioral regulation.
15787141|NCT04555616|Behavioral|Placebo|Participants' caregivers will receive a set script of placebo modifications.
15787142|NCT04555603|Drug|Inlyta|axitinib
15787143|NCT04555603|Drug|Bavencio|avelumab
15787144|NCT04555603|Drug|Keytruda|Pembrolizumab
15787145|NCT04555590|Behavioral|H-HOPE Intervention|The H-HOPE intervention (Hospital to Home: Optimizing the Preterm Infant's Environment) to promote early infant development and parental engagement. H-HOPE includes ATVV, which provides Auditory (voice), Tactile (moderate touch massage), Visual (eye to eye), and Vestibular (rocking) stimulation with a parent-directed component which provides participatory guidance and social support to engage with their infants.
15787146|NCT04555577|Drug|Nedisertib|Given PO
15787147|NCT04555577|Radiation|Radiation Therapy|Undergo radiation therapy
15787148|NCT04555577|Procedure|Resection|Undergo surgical resection
15787149|NCT04555577|Drug|Temozolomide|Given PO
15787150|NCT04555564|Procedure|Technicium 99 MAA infusion|4mci of Technicium 99 MAA will be infused into the bronchial artery via a catheter prior to a standard therapy (bronchial artery embolization). The patient will undergo nuclear medicine imaging following this intervention to quantify MAA distribution within the lung tumor and adjacent lung tissue.
15787152|NCT04555538|Diagnostic Test|Cardiac MRI|These are routinely performed for many cardiac conditions, including atrial arrhythmias. The adverse effects are small but include claustrophobia and metallic objects. Therefore all patients will be counselled prior to the scans by an experienced MRI practitioner and standard measures will be taken to avoid distress during the scan. Furthermore, patients will be screened using routine clinical protocols in order to avoid any harm due to interaction of the MRI scanner with metallic objects.
15787153|NCT04555525|Drug|sarecycline|sarecycline tablet
15787154|NCT04555525|Dietary Supplement|Centrum Adult Multivitamin|Centrum Adult Mulltivitamin tablet
15787155|NCT04555512|Other|Progressive High Intensity Interval Training (PRO-HIIT)|Individual exercise training sessions, involving two weeks of moderate intensity continuous exercise and 10 weeks of interval exercise training. This protocol involves progression of training of 3 stages: 1) six high-intensity intervals (at an RPE of 15-18) of 1-min separated by five low-intensity intervals of 2-min; 2) three high-intensity intervals of 2-min separated by two low-intensity intervals of 4-min, and a further 2-min of low intensity following the last interval before cool-down; and 3) three high-intensity intervals of 3-min separated by two low-intensity intervals of 3-min, and a further 1-min of low intensity following last interval before cool-down.
15787156|NCT04555512|Other|Constant High Intensity Interval Training (CON-HIIT)|Individual exercise training sessions, involving two weeks of moderate intensity continuous exercise and 10 weeks of interval exercise training. This protocol involves a constant protocol of training, including six high-intensity intervals (at an RPE of 15-18) of 1-min separated by five low-intensity intervals of 2-min.
15787157|NCT04555499|Other|Standardized neurological examination|
15787158|NCT04555486|Drug|DCR-PHXC|Intervention, drug, DCR-PHXC
15787159|NCT04555486|Drug|Sterile Normal Saline (0.9% NaCl)|Placebo comparator
15787160|NCT04555473|Procedure|Tumor biopsy|"Both interventions performed at baseline upon study enrolment (pre- and post-NACT for NACT+IDS patients) and at the time of recurrence.
~Part of each surgical specimen will be used to obtain organoids, whereas part will be frozen for direct comparative analysis of the original tumor (1-6 organoids from each patient).
~Blood samples will be collected to purify extracellular circulating RNA (cRNAs)."
15787161|NCT04555460|Procedure|Hemicraniectomy|Large hemicraniectomy and duraplasty
15787162|NCT04555460|Other|Conservative medical therapy|Conservative medical therapy was based on published guidelines for the early management of patients with ischemic stroke
15787163|NCT04555447|Dietary Supplement|Agavins (prebiotic fiber)|Agavins contained in ready-to-use sachets were dissolved in water, and participants consumed the corresponding dose daily (2.5, 5.0, 7.0, 10 or 12 g) for 1 week, preferentially in the evening. Participants followed a 5-week dose-escalation intervention.
15787164|NCT04555447|Dietary Supplement|Placebo|Maltodextrin contained in ready-to-use sachets was dissolved in water, and participants consumed the corresponding dose daily (2.5, 5.0, 7.0, 10 or 12 g) for 1 week, preferentially in the evening. Participants followed a 5-week dose-escalation intervention.
15787165|NCT04555434|Dietary Supplement|Probiotics|"Experimental group Main ingredients: P. pentosaceus KID7, L. lactis CKDB001 or L. helveticus CKDB001 (containing 9 × 10^9 CFU / day)
~Control group Main ingredient: Crystalline cellulose"
15787226|NCT04554849|Other|Gender dysphoria psychosocial health|Retrospective analysis of medical records
15787227|NCT04554836|Drug|Cetuximab|Patients in Arm A will receive FOLFIRI +cetuximab.
15787228|NCT04554836|Other|FOLFIRI|Irinotecan, Folinic acid (racemic), Fluorouracil (5-FU)
15787166|NCT04555421|Device|Lumen|Subjects will use the Lumen device and mobile phone application, which will guide their diet, sleep, and routines according to their Lumen measurements. In addition, a Lumen coach will be assigned to the subjects, and they will have a 30 minutes video call with the coach during the familiarization stage, in order to acquaint them with Lumen and explain them about the application and the nutritional guidance.
15787167|NCT04555408|Device|blue light|Patients receive exposure to 100lux blue light, which dominant wave-length is 468nm for 30 minutes in the morning.
15787168|NCT04555408|Device|bright light|Patients receive exposure to 1000lux bright light, which dominant wave-length is 490nm for 30 minutes in the morning.
15787169|NCT04555408|Device|dim light|Patients receive exposure to 100lux dim light, which dominant wave-length is 490nm for 30 minutes in the morning.
15787170|NCT04555395|Other|survival rates|survival rates
15787171|NCT04555382|Diagnostic Test|Blood and Urine|Blood and urine samples are collected every twelve hours when the patients are included in the study during observation period.
15787172|NCT04555369|Genetic|ct-DNA|The enrolled mCRC patients will perform ct-DNA testing to evaluate drug efficacy of chemotherapy, at the time of baseline and after the first cycle of chemotherapy.
15787173|NCT04555343|Drug|Tranexamic acid|1gm instilled instravesically
15787174|NCT04555330|Device|Physical activity measurement|"To assess physical activity two small tri-axial accelerometers embedded in medical Band-Aids will be used. The accelerometers are discretely worn on the lateral aspect of the thigh.
~The accelerometers sample accelerations continuously during hospitalisation and are connected wirelessly to a tablet that via an inbuilt algorithm classify the recordings as bedridden (lying down), sitting, standing, and walking."
15787175|NCT04555330|Device|Visual Feedback|The tablet will be placed on the patients bedside table and provides feedback on the amount of physical activity and motivational imagesand texts that will be visible for the patients, the health care staff and visitors.
15787176|NCT04555317|Combination Product|Musculoskeletal health package|3 month prehabilitation exercise program during radiotherapy with assessment of BMD at baseline with appropriate management according to fracture risk assessment (with either (a) lifestyle advice, (b) calcium and vitamin D (c) calcium, vitamin D and bisphosphonate (alendronate))
15787177|NCT04555304|Drug|KH903 + Paclitaxel|KH903 4 mg/kg will be administered intravenously on D1 D8 D15and D22 in a 28-day cycle； Paclitaxel 80 mg/m² will be administered intravenously on D1, D8 and D15 in a 28-day cycle
15787178|NCT04555304|Drug|Placebo + Paclitaxel|Placebo will be administered intravenously on D1 D8 D15and D22 in a 28-day cycle； Paclitaxel 80 mg/m² will be administered intravenously on D1, D8 and D15 in a 28-day cycle
15787179|NCT04555291|Drug|Ropivacaine injection|Realization of the quadratum lumborum block type 3, ultrasounds' guided by the injection of 20 ml of ropivacaïne 2 mg/ml
15787180|NCT04555291|Other|NACL|Realization of the quadratum lumborum block type 3, ultrasounds' guided by the injection of 20 ml of NACL
15787181|NCT04555278|Device|Active rTMS|"A figure-of-8 coil connected to a biphasic Magstim Rapid 2 stimulator (The MagstimCo, Whitland, UK) will be used. Coil orientation and position will be guided throughout the experiment by a neuronavigation system (Brainsight, Rogue research, Montreal, QC, Canada). The intensity of rTMS will be set at 95 % of the first dorsal interosseous (FDI) resting motor threshold (RMT).
~Active rTMS will consist of 40 trains of 5 seconds each at 10 Hz (25-s intertrain interval) applied over M1 (on FDI cortical representation), for a total of 2000 stimulations lasting 20 minutes."
15787182|NCT04555278|Device|Sham rTMS|A sham coil will be use (e.g. equipped with a magnetic shield that blocks the magnetic field). The sham stimulation will last the same duration as the active rTMS (30 min).
15787183|NCT04555278|Other|Motor Control Exercises|The rehabilitation program will consist of a 30-minute session of motor control exercises following the rTMS (Active or Sham) intervention. This approach aims to improve spine health through the optimization of spine loading. The first session will be preceded by an individualized evaluation of the participant's abilities and deficiencies to tailor the training program to each participant.
15787184|NCT04555265|Device|Radiofrequency ablation or microwave ablation|Hepatocellular carcinoma treated by either radiofrequency ablation or microwave ablation
15787185|NCT04555239|Procedure|Fascial Distortion Model (FDM)|"Only treatment of herniated trigger points, continuum distortions, and/or trigger bands will be performed.
~Herniated trigger points are single areas of sharp pain within soft tissue.
~Continuum distortions are single points of sharp pain overlying bony tissues.
~Trigger bands are lines of pain overlying either soft or bony tissues.
~Treatment with FDM is performed using firm, direct pressure over the area of the patient's pain with the provider's thumb. This pressure is applied at a single point or area indicated by the patient for herniated trigger points and continuum distortions, and along the indicated line of pain for trigger bands."
15787186|NCT04555239|Other|Standard Care|"The usual standard of care for extremity pain varies from provider to provider and varies from patient to patient depending upon their comorbidities but often includes some combination of the following:
~X-rays, if suspicion for fracture exists
~Venous duplex ultrasound, if suspicion for DVT/SVT exists
~Computed tomography (CT) angiogram (CTA), if suspicion for arterial occlusion exists
~C-reactive Protein (CRP)/erythrocyte sedimentation rate (ESR)/arthrocentesis is suspicion if suspicion for septic arthritis exists
~Arthrocentesis if suspicion for gout exists
~Splinting/casting/immobilization
~NSAIDs, Tylenol, or opioids for pain control
~Possibly trigger point injections
~Possibly osteopathic manipulation
~Recommendations to use RICE (rest, ice, compression, elevation) at home
~Physical/occupational therapy referral
~Orthopedic referral"
15787187|NCT04555226|Procedure|Lymph node dissection|Open/minimaly invasive pelvic and para-aortic lymph node dissection
15787188|NCT04555226|Radiation|Standard chemoradiation|"A point/HCR-CTV D90 ≥80Gy（+20%）
~Extended-field EBRT: image-positive common iliac lymph nodes with short diameter ≥10mm and/or image-positive para-aortic lymph node
~Target doses for the image-positive nodes can range from 55 to 60Gy
~Concurrent 5 cycles platinum-containing chemotherapy (Cisplatin 40mg/m2 q1w or Carboplatin AUC=2 q1w, Window period 1 week)
~CCRT will be completed in 56 days
~After CCRT if the cervix biopsy shows residual tumor and/or imaging (CT/MRI/PET/CT) indicates that there are still positive lymph nodes with short diameter ≥15mm in the pelvic and abdominal cavity, 3 cycles adjuvant chemotherapy (TP: Paclitaxel 135mg/m2, Cisplatin 50mg/m2, q3w or TC: Paclitaxel 135mg/m2, Carboplatin AUC=4, q3W; Window period 2 weeks) ± brachytherapy (if point A or HR-CTV D90 < 96Gy) will be performed."
15787312|NCT04554056|Drug|MW05|Recombinant (yeast secreted) human serum albumin-human granulocyte colony stimulating factor (I) fusion protein injection
15787189|NCT04555226|Radiation|Chemoradiation|"A point/HCR-CTV D90 ≥80Gy（+20%）
~Extended-field EBRT: Pathlogical positive para-aortic lymph node
~Target doese for pelvic and/or abdomal lymph nodes is usually 45Gy. After operation, the residual lymph node need to be labeled and the target doses for it ranges from 55-60Gy.
~Concurrent 5 cycles platinum-containing chemotherapy (Cisplatin 40mg/m2 q1w or Carboplatin AUC=2 q1w, Window period 1 week)
~CCRT will be completed in 56 days
~After CCRT if the cervix biopsy shows residual tumor and/or imaging (CT/MRI/PET/CT) indicates that there are still positive lymph nodes with short diameter ≥15mm in the pelvic and abdominal cavity, 3 cycles adjuvant chemotherapy (TP: Paclitaxel 135mg/m2, Cisplatin 50mg/m2, q3w or TC: Paclitaxel 135mg/m2, Carboplatin AUC=4, q3W; Window period 2 weeks) ± brachytherapy (if point A or HR-CTV D90 < 96Gy) will be performed."
15787190|NCT04555213|Drug|NOX66|NOX66 Suppository
15787191|NCT04555174|Device|Orsiro Mission DES|Percutaneous Coronary Intervention (PCI)
15787192|NCT04555161|Device|Aria CV Pulmonary Hypertension System|The Aria CV PH System is indicated for the treatment of adult patients with World Health Organization (WHO) Group I Pulmonary Arterial Hypertension who remain symptomatic despite treatment with optimal medical therapy.
15787193|NCT04555148|Biological|GC5131|COVID19 Hyper-Immunoglobulin
15787194|NCT04555148|Other|Placebo|Placebo
15787195|NCT04555135|Device|EndoVigilant Software|While using this device, colonoscopy will continue to be performed in the standard manner as is done without the use of this device. The video signal from the colonoscope will be fed into a computer running the EndoVigilant software in addition to the standard video output to the procedure monitor. The gastroenterologist performing the procedure will therefore be able to observe a standard colonoscopy video on the primary monitor and the augmented video on the second monitor. The gastroenterologist may rely on the second monitor (with augmented video generated from EndoVigilant software) for polyp detection, but the standard procedure monitor with the original feed will always be operational and available for maneuvers such as fast insertion, polypectomy etc.
15787196|NCT04555122|Behavioral|Social Distancing Advertisements|Participants will receive 3 types of advertisements to increase social distancing/staying at home.
15787197|NCT04555096|Drug|GC4419|180 Minute IV Infusion
15787198|NCT04555096|Drug|Placebo|180 Minute IV Infusion
15787199|NCT04555057|Procedure|Music therapy|Music selected according to the patient's individual preferences.
15787202|NCT04555031|Device|kalifilcon A lenses|Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.
15787203|NCT04555031|Device|Dalies Total 1|Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.
15787204|NCT04555031|Device|Precision 1|Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.
15787205|NCT04555031|Device|Biotrue ONEday|Participant will wear the lens for each timepoint of 5, 10 and 15 minutes. A new lens will be inserted for each timepoint.
15787206|NCT04555005|Other|Mindfulness based intervention|Mindfulness based intervention for frontline healthcare workers during COVID-19 outbreak
15787207|NCT04554992|Biological|COVID 19 Convalescent Plasma|COVID 19 convalescent plasma is a blood product collected from donors who have recovered from a previous COVID 19 infection
15787208|NCT04554979|Drug|Hydroxychloroquine Pill|hydroxychloroquine 400 mg twice daily first day and maintained on 200 mg twice daily for 6 days in mild cases and 10 days in moderate cases. Also they received anticoagulants, vitamin c and zinc. In case of secondary bacterial infection, empiric antibiotics are started
15787209|NCT04554966|Drug|ABBV-382|Intravenous (IV) infusion
15787210|NCT04554966|Drug|ABBV-382|Subcutaneous (SC) injection
15787211|NCT04554966|Drug|Placebo for ABBV-382|Intravenous (IV) infusion
15787212|NCT04554953|Drug|Combination drug containing fimasartan and statins|"Patients who correspond to one of the following:
~Patients who are planning to be treated with a combination drug containing fimasartan and statins after being newly diagnosed with essential hypertension and primary hypercholesterolemia
~Patients who are planning to switch to a combination drug of fimasartan and statins, among those who have been diagnosed with essential hypertension or primary hypercholesterolemia and are receiving hypertension treatment that is containing an ARB or dyslipidemia treatment that is containing a statin
~Patients who are planning to switch to a combination drug of fimasartan and statins, among those who have been diagnosed with essential hypertension and primary hypercholesterolemia and are receiving hypertension treatment that is containing an ARB and dyslipidemia treatment that is containing a statin"
15787213|NCT04554940|Biological|vosoritide|Subcutaneous injection of 30μg/kg (ages 0 - <2 years old) or 15 μg/kg (ages >2 years old) of vosoritide daily
15787214|NCT04554927|Other|WEB-Application|The patients of the Web-application arm will be trained on the devices and the application will be installed either on their smartphone or on another support (computer, tablet).
15787215|NCT04554927|Other|Standard accompaniment|Personalized schedule of medical follow-up given to the patient
15787216|NCT04554914|Biological|Tabelecleucel|Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.
15787217|NCT04554901|Dietary Supplement|Cocoa|2-week, once-daily 70%, 50g cocoa bar manufactured by The UWI Cocoa Research Institute (14 bars)
15787218|NCT04554888|Drug|Doxepin Topical|Four of the areas will be treated with doxepin for 1 hour and 30 minutes (with a patch to deposit 1.2 grams of cream). Each patch will be covered with Tegaderm I.V., an occlusive, adhesive dressing (3M), for at least 1½ hours
15787219|NCT04554888|Drug|Papain|Papain will be applied by 1 SPT prick thought the skin
15787220|NCT04554888|Drug|Histamine|Histamine will be applied by 1 SPT prick thought the skin
15787221|NCT04554888|Other|Cowhage|Cowhage spicules are 1-2 mm in length and have diameter of 1-3 µm at their tip. 30-35 spicules are gently rubbed into a 1 cm diameter skin area.
15787222|NCT04554875|Diagnostic Test|A scoring system|The scoring system was used to rate score patients.
15787223|NCT04554862|Drug|Magnesium sulfate|magnesium sulfate will be added to the block
15787224|NCT04554862|Drug|Ketorolac Tromethamine|ketorolac will be added to the block
15787225|NCT04554862|Procedure|supraclavicular block|it is done by ultrasound- guided
15787229|NCT04554823|Behavioral|Health Education|Will attend lectures on health education about Health and Physical Education, healthy eating, overcoming barriers, Back to routine, Physical Activity Options and Dealing with Stress and Depression
15787230|NCT04554823|Behavioral|Physical Exercise|Supervised physical training program of combined exercises for 24 weeks, with frequency of 3 times weekly and duration of 60 minutes, an unsupervised flexibility training program 2 times a week.
15787231|NCT04554810|Other|Medication Management Service|Medication review was delivered to the Syrian refugees by accredited pharmacists at the baseline visit. This followed by identifying the treatment-related problems (TRP) by the clinical pharmacist, and correction of the approved TRPs by the corresponding physicians and finally convey these changes in medications to the patients. In addition, counselling and education were delivered to the refugees' patients in the base line visit.
15787232|NCT04554797|Other|Regional Hypothermia|Regional hypothermia was achieved by intraarteral perfusion of cold fluid into the ischemic area of the brain
15787233|NCT04554784|Other|Conventional|Patients' condition will be continue managed by pain specialists with regular follow-ups and continue patients' active concurrent pain treatment such as taking analgesics, physiotherapy, massage, chiropractor.
15787234|NCT04554784|Procedure|Bowen|"Patients will be referred to Occupational therapist for Bowen Therapy. There will be a week washout period before the start of Bowen Therapy. During a week washout period and study period, patients can continue taking analgesia, but advised to stop the concurrent treatments which can affect the deep tissue such as massage, physiotherapy, and chiropractic to minimize the counteracting effect on the Bowen's action.
~During a Bowen Therapy session, patients will lie relaxed on the examination couch wearing loosely fitting clothing or only the affected area being exposed. The therapist applies a series of gentle movements across the body. The gentle movements focus on a body of muscle, tendon or nerve and release tension through the nerve within the area. Each session will last for 30 minutes to an hour. After each session, the next appointment will be given to patients. The first four sessions will be scheduled on weekly basis, and the remaining four on biweekly session."
15787235|NCT04554771|Drug|Tocilizumab 20 Mg/mL Intravenous Solution|tocilizumab 8 mg/kg with a maximum of 800 mg intravenously on day 1, 15 and 29 of standard of care neoadjuvant chemoradiation
15787236|NCT04554771|Drug|Paclitaxel|Paclitaxel 50 mg/m2 will be given intravenously on days 1, 8, 15, 22 and 29
15787237|NCT04554771|Drug|Carboplatin|Carboplatin AUC = 2 will be given intravenously on days 1, 8, 15, 22 and 29
15787238|NCT04554771|Radiation|External beam radiotherapy|External beam radiotherapy will be delivered to a total dose of 41.4 Gy in 23 fractions of 1.8 Gy, 5 fractions per week starting the first day of the first cycle of chemotherapy
15787239|NCT04554758|Procedure|Sleeve gastrectomy|Bariatric operation will be done by laparoscopic sleeve gastrectomy procedure.
15787240|NCT04554758|Procedure|Roux-en-Y gastric bypass|Bariatric operation will be done by laparoscopic Roux-en-Y gastric bypass procedure.
15787241|NCT04554745|Other|ultrasound|antenatal care of outpatient obstetrics follow up with three visits
15787242|NCT04554732|Drug|Keratinocyte growth factor|At the end of 4 cycles of chemotherapy, primary efficacy end point data will be collected. After 20 evaluable subjects if ≥ 4 responses were noted, part 2 of the study will be activated. The decision rule is based on the lower bound of a one-sided 95% confidence interval; at least 4 out of 20 patients with response results in a lower bound greater than 5% success. The proportion with success and the lower bound of a one-sided exact confidence interval will be computed.
15787243|NCT04554719|Drug|68Ga-DOTA-FAPI|Intravenous access is established in advance, intravenous bolus injection, 68Ga-DOTA-FAPI dose is about 1.85-3.7 MBq/kg body weight (0.05-0.1 mCi/kg), rinsed with 0.9% saline, and hydrated after drinking more water.
15787244|NCT04554719|Device|PET/MR|Each subject undergoes PET/MR imaging within 40-60 minutes after injection.
15787245|NCT04554719|Device|PET/CT|Each subject undergoes PET/CT imaging within 40-60 minutes after injection.
15787246|NCT04554706|Behavioral|Mobile-phone delivered Treatment for Excessive Rumination|This is a one-month three-arm clinical control trial to reduce the rumination and interpersonal impairment link.
15787247|NCT04554693|Drug|Metronidazole Oral|250 mg oral three times a day for 14 days
15787248|NCT04554693|Drug|Placebo|Halal and Kosher certified gelatin placebo capsules oral three times a day for 14 days
15787249|NCT04554680|Drug|dabrafenib and trametinib|"Participants will receive systemic therapy in the form of oral tablet dabrafenib 150mg twice a day & oral tablet trametinib 2mg once a day for 1 or 4 weeks.
~Pre- & post-systemic therapy assessment of tumor iodine absorption is done using I-124 PET CT scan. Participants are prepared for this scan with intramuscular injection of thyrogen 0.9mg on 2 consequent days, followed by I-124 PET-CT scan over the next 3 days for tumoral lesional dosimetry.
~Participants are then started on systemic therapy for 1 week, followed by I-124 PET-CT scan. If at least one tumor site can attain adequate dosimetry, RAI (I-131) treatment under thyrogen stimulation will be considered. Systemic therapy will be stopped 3 days after I-131.
~If after 1 week of systemic therapy, tumors do not reach dosimetry criteria, participants will be continued on systemic therapy for a total of 4 weeks duration, followed by I-124 PET-CT scan. If tumor can attain adequate dosimetry, I-131 treatment will be considered."
15787250|NCT04554667|Behavioral|Exercise Intervention|Heavy Lifting Strength Training
15787251|NCT04554654|Diagnostic Test|transvaginal ultrasound,|transvaginal ultrasound performed on day of the start of progesterone supplementation and on the day of frozen embryo transfer; serum progesterone level measurement on day of frozen embryo transfer
15787252|NCT04554641|Other|Fasted breath samples|Participants will provide fasted breath samples pre and post Bio-Kult Advanced.
15787253|NCT04554641|Other|Daily Diary|Monitoring stool form, consistency and frequency on a daily basis.
15787254|NCT04554641|Other|Stool sample|Participants will provide stool sample pre and post Bio-kult Advanced.
15787255|NCT04554628|Diagnostic Test|ELISA test in urine|enzyme linked immunosorbent assay technology for detection of UNGAL and UKIM1 in urine in postoperative ICU patients
15787256|NCT04554615|Drug|Insulin|insulin infusion to control postoperative hyperglycemia
15787257|NCT04554602|Diagnostic Test|Fusion ultrasound|Fusion ultrasound is a technique that allows a volume acquired in MRI to be coupled to an ultrasound scan with real-time image synchronisation.
15787258|NCT04554589|Drug|Glycopyrrolate 0.2 MG|injections
15787259|NCT04554589|Drug|normal saline|normal saline
15787400|NCT04553406|Drug|Placebo|4 capsules of matching placebo
15787260|NCT04554576|Behavioral|Chronic Disease Self-Management Program (CDSMP) for chronic pain in Spanish|"The CDSMP meets for 2.5 hours for 6 weeks. Topics covered are: understanding pain, finding resources, mindfulness, pain science, pacing, exercise, relaxation, communication, sex/intimacy, healthy eating, weight and medication management, making treatment decisions and confronting fears.
~Participants are encouraged to create their own personal health goals and make weekly action plans to meet their personal goals. Each week participants learn new tools and problem-solving techniques to meet their health goals and themes are repeated throughout 6-week period to ensure understanding and integration. Participants are encouraged to problem-solve and ask questions to the group about creating and carrying out their self-management plan.
~The intervention follows the content of the book Programa de Manejo Personal del Dolor Crónico (Living a Healthy Life with Chronic pain)"
15787261|NCT04554576|Behavioral|Remote feedback active group|After the 6-week self management program, half the participants will be randomized to an every 6 weeks for 6 months phone or video visit from a health care provider, in Spanish. The phone or video sessions will include: review previous action-plans (goals) and provide support in forming new action-plans (goals)
15787262|NCT04554576|Behavioral|Remote feedback control group|After the 6-week self-management program, half the participants will be randomized to a control group for 6 months.
15787263|NCT04554563|Other|Core stability training|20 sessions of specific core stability exercise with no external loading.
15787264|NCT04554537|Behavioral|SMART|A treatment program developed to address specific brain functions found to be crucial for the recovery following brain injury.
15787265|NCT04554537|Behavioral|Brain Health Workshop|A psychoeducation program designed to provide in depth information to participants about the neuroscience behind their TBI and PTSD and the symptoms and challenges they may experience.
15787266|NCT04554524|Drug|Chemotherapy+Pembrolizumab.|Eligible subjects will receive 4 cycles carbo-paclitaxel/ nab-paclitaxel combined with pembrolizumab. Response rate assessed by the site investigators according to the Response Evaluation Criteria In Solid Tumors (RECIST v1.1). After 4 cycles treatment, complete response subjects continue carbo-paclitaxel/ nab-paclitaxel combined with pembrolizumab up to disease progression, some of partial disease and stable disease subjects can receive surgical treatment. And then continue carbo-paclitaxel/ nab-paclitaxel combined with pembrolizumab up to disease progression, other partial disease and stable disease subjects cannot be removed by surgery will continue carbo-paclitaxel/ nab-paclitaxel combined with pembrolizumab for 4 cycles and then pembrolizumab or Normal Saline up to disease progression.
15787267|NCT04554498|Device|1) high flux hemodiafiltration thrice -weekly during a 24 month follow-up|"the comparison of the effects of the two membranes on the serum levels of albumin, B2M, CRP, myoglobin, light chains, retinol binding protein, homocysteine, p-cresol, indoxyl sulfate, BPA, alpha-1-microglobulin (A1M), FGF23 (fibroblast growth factor 23), and inflammatory cytokines;
~the evaluation of the changes induced by the two filters on lymphocyte subsets, monocyte activation and senescence, and apoptosis rate;
~the definition of the impact of the two membranes on the accumulation of AGEs as an index of metabolic and oxidative stress, determined by a non-invasive method based on the measurement of skin autofluorescence through a dedicated device (AGE Reader, DiagnOptics Technologies BV, Groningen, Netherlands)."
15787268|NCT04554485|Drug|Blinatumomab|Single cycle of blinatumomab followed by high-dose chemotherapy in the induction therapy for Ph-negative acute lymphoblastic leukemia in adults
15787269|NCT04554472|Diagnostic Test|Intraoperative ultrasound|During the surgery, the standard AP and lateral x-rays will be performed. Additional projections (lateral 30 degrees tilt, and dorsal tangential view) will also be registered. Finally an intraoperative ultrasound of the wrist extensor tendons will be taken, checking the compartments individually in order to detect invasion of the dorsal cortex by the screws. In case of no protrusion, the patient will be registered as a correct fixation. Otherwise, it will be specified which position of the plate and which compartment the screw/s protrude. A screw with a correct measurement will then be replaced and implanted and recorded as a measurement error.
15787270|NCT04554459|Drug|Ponatinib 15 MG Oral Tablet|ponatinib plus reduced-intensity chemotherapy in first-line treatment of Adult Ph+ ALL
15787271|NCT04554446|Procedure|T-MSAT(Motion style acupuncture treatment using traction)|Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle created in Jaseng Hospital. T-MSAT(Motion style acupuncture treatment using traction) is a kind of MSATs, and a treatment that improves musculoskeletal problems by pulling the patient's body through the device and giving instructions for walking while being acupuncture.
15787272|NCT04554446|Procedure|Korean medicine treatment|acupuncture, chuna, pharmacoacupuncture and Korean herbal medicine.
15787273|NCT04554433|Drug|Ethanol with Asprin|"Group ( A ) which will receive the new protocol will be categorized into sub-groups according to the medical conditions , inclusion criteria , investigations and symptoms .
~Inhaling alcohol vapor through nostrils .
~Inhalation of Alcohol vapor driven by Oxygen .
~Inhalation of Alcohol vapor driven by oxygen in case of ARDS.
~Ethyl Alcohol infusion into the airway . Investigations will be made before starting the protocol and follow up data will be collected every day .
~Follow up test will be done according to the schedule . PCR test will be done according to the duration of each technique to evaluate the final results ."
15787274|NCT04554420|Behavioral|Youth Participatory Action Research-Mental Health Curriculum|The mental health curriculum will focus on enhancing the knowledge, critical consciousness (i.e., exploration of systemic/racial problems), research self-efficacy, and other skills of youth to integrate their lived experiences and identity to learning about the intersection of system and community level issues in mental health. Activities will center on participatory action approaches to engaging youth in culturally/community responsive ways.
15787275|NCT04554407|Device|SOMAVAC® 100 Sustained Vacuum System|The SOMAVAC® 100 is a battery operated device that delivers 100mm/Hg of continuous suction.
15787276|NCT04554394|Device|CellFX Device|The CellFX System utilizes non-thermal, localized delivery of a timed series of low energy, nanosecond electrical pulses that can trigger regulated cell death.
15787277|NCT04554381|Biological|JL1 antigen|we hypothesis that JL1 can be used as an adjunctive marker for the initial diagnosis and the follow up of Acute Lymphoblastic Leukemia.
15787309|NCT04554108|Other|therapeutic strategy|Outpatient management strategy of acute non-severe osteomyelitis in children with oral antibiotic therapy compared to a standard strategy with conventional hospitalization and intravenous antibiotic therapy
15787310|NCT04554095|Other|Clinical data collection|Respiratory parameters, analytic values, lung ultrasound and echocardiography
15787278|NCT04554368|Procedure|intra-arterial contrast enhanced Flat Detector CT|After femoral artery puncture, FDCT scan (if necessary) and IA-CEFDCT scan were performed on a single flat-detector angiography system (Allura Xper FD20, Philips Medical systems, Best, the Netherlands), respectively. FDCT was acquired with the following acquisition parameters: 20s rotation, 220° rotation, 617 single frames at a frame rate of 30/s, 48cm detector field of view, 1024 acquisition matrix. Images were reconstructed using a soft-tissue kernel with an isotropic voxel size of 0.9 × 0.9 × 0.9 mm on a dedicated workstation for FPCT data (XperCT Dual 3.2.0). For image analysis, these isotropic FDCT data were viewed in the axial plane with 5 mm slice thickness.
15787279|NCT04554355|Behavioral|School-based PA intervention|Provide moderate to vigorous fun-game based exercises for adolescents with ID in schools to help them reduce obesity and improve fitness levels.
15787280|NCT04554342|Other|V01 candy|candy with sweetener (Isomalt) and apple flavour
15787281|NCT04554342|Other|V02 candy|candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid)
15787282|NCT04554342|Other|V03 candy|candy with with sweetener (Isomalt) and apple flavour and acidifying agent (apple acid + citric acid) and Vitamin C
15787283|NCT04554342|Other|V04 candy|candy with sweetener (Isomalt) (control group 1)
15787284|NCT04554342|Other|V05 candy|candy with with sweetener (Isomalt) and acidifying agent (apple acid + citric acid) (control group 2)
15787285|NCT04554329|Procedure|bandage contact lens|bandage contact lens
15787286|NCT04554316|Device|Steri-strip|Steri-Strips (3M Health Care, St. Paul, Minn) are a commonly used means of covering surgical incisions following many operations. Use of adhesive surgical tape over incisions maintains epidermal approximation in primary skin closure while limiting exposure to the environment, theoretically improving cosmesis and limiting risk of infection.
15787287|NCT04554303|Drug|S-amlodipine 2.5mg|Oral administration, 1 tablet per day
15787288|NCT04554303|Drug|Amlodipine 5mg|Oral administration, 1 tablet per day
15787289|NCT04554290|Diagnostic Test|temporal artery biopsy|description of temporal artery biopsy features, and its correlation with diagnosis of giant cell arteritis or other differential diagnoses.
15787290|NCT04554277|Biological|Biomarker guided therapy|Guided therapy using sST-2 monitoring at the discharge from initial hospitalisation, 6, 12, 18 and 24 months of following.
15787291|NCT04554264|Other|questionnaire|Inventory of Complicate Grief (ICG) score in relative from patients who died in ICU after SARS-Cov2 infection. This is the most commonly used assessment tool for complicated grief which focuses on different symptoms than depression or anxiety. A score > 25 indicate complicated grief.
15787292|NCT04554251|Other|Survey|invited questionnaire
15787293|NCT04554238|Device|Armeo spring|Armeo spring is an exoskeleton that allows intensive therapy aimed at upper extremity tasks, which can be regulated according to the anthropometric measurements of the child and the objective of the session. The software contains an extensive library of game-like exercises that are run in a motivating and informative virtual reality training environment, clearly showing the functional task to be performed through immediate feedback in a 3D work space.
15787294|NCT04554238|Other|Occupational Therapy|This treatment includes passive stretching exercises, weight bearing, stimulation of protective reactions, muscle strengthening exercises and different types of motivating bimanual games, favoring reaching, grasping, exploration and manipulation.
15787295|NCT04554225|Drug|Oxygen gas|Oxygen administered to a patient using ambulatory oxygen
15787300|NCT04554199|Device|Flexible partial denture|removable partial dentures (RPDs) were fabricated using thermoplastic resins (flexible RPDs). EEG and MMSE were evaluated before denture delivery and after one month of denture wear.
15787301|NCT04554186|Procedure|Serratus anterior plane block|Injection of bupivacaine between serratus anterior plane and latissimus dorsi muscle using ultrasound
15787302|NCT04554186|Procedure|Thoracic Paravertebral block|Injection of bupivacaine in the thoracic Paravertebral space using ultrasound
15787303|NCT04554186|Procedure|Control|Place a fentanyl patch 50 microgram
15787304|NCT04554173|Procedure|surgical resection neurogenic tumors|Patient who was treated for a thoracic neurogenic tumor by minimally invasive surgery
15787305|NCT04554160|Device|Loop recorder implantation|A loop recorder is implanted in the start of the study after informed consent is signed and enables continuous cardiac monitoring.
15787306|NCT04554147|Behavioral|FAITH! App-enhanced Hypertension Intervention|"FAITH! HTN App: The program promotes HTN self-management through a 10-week education module series on HTN. Participants will follow each module weekly and use a wireless home BP monitor for self-tracking which syncs to the app. The app includes module quizzes, a BP tracking dashboard and a moderated sharing board to foster discussion on HTN management.
~Patient-Provider-CHW ICM. The patient-provider-CHW triad works together for personalized, collaborative goal setting. The patient will complete app modules, self-monitor BP, and engage with a sharing board integrating HTN topics. At weekly virtual visits (telephone or video), the CHW will record patient BPs, assist with addressing social determinants of health (SDOH) identified by the patient (eg, local community resources), and review HTN modules. The CHW will upload clinical/SDOH data to the patient electronic medical record (EMR) for FQHC care providers to review. This cycle will be completed weekly over the 10-week intervention."
15787307|NCT04554121|Behavioral|Brain Basics|"Computer-based exercises targeting impairments in cognitive domains (sensory processing, processing speed, attention, working memory, memory) are paired with verbal discussions and group-based activities to strengthen metacognition and to bridge newly learned cognitive skills to everyday.
~life."
15787308|NCT04554121|Behavioral|Brain Training|Computer-based exercises targeting impairments in cognitive domains (processing speed, attention, working memory, executive functions) are paired with verbal discussions and group-based activities to strengthen metacognition and to bridge newly learned cognitive skills to everyday life.
15787311|NCT04554082|Procedure|laparoscopic sleeve gastrectomy|bariatric surgery to loss weight
15787313|NCT04554056|Drug|PEG-rhG-CSF|PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor
15787316|NCT04554030|Behavioral|Evaluate sperm count before and after immunotherapy|Evaluate sperm count before and after immunotherapy
15787317|NCT04554017|Other|Education/Training|It consisted of a brief overview of hypertension, risk factors, complications and much emphasis placed on the preventive measures (what they include and why it is necessary to practice them).
15787318|NCT04554004|Diagnostic Test|CCTA, CT-MPI, DSA, FFR|The patients who enrolled the study will undergo coronary CT angiography(CCTA), dynamic CT-MPI, invasive coronary angiography and invasive computation of fractional flow reserve (FFR)
15787319|NCT04553991|Procedure|Ultrasound guided QL block|20 mL of 0.25% bupivacaine was applied bilaterally at the anterolateral border of the QL at its junction with transversalis fascia
15787320|NCT04553991|Procedure|Ultrasound guided TAP block|20 mL of 0.25% bupivacaine was applied bilaterally in the TAP
15787321|NCT04553978|Drug|WD-1603|WD-1603 CARBIDOPA/LEVODOPA EXTENDED-RELEASE TABLETS
15787322|NCT04553952|Other|Measurement of gingival display|"All individuals were instructed to sit on a dental chair and the measurements were made by using a millimetric ruler. Next, the patients were grouped according to Liebart's classification by gingival display at maximum smile as follows:
~Class 1.Excessive gingival display (Gummy smile): ≥ 3mm gingival display Class 2.High smile line: 0-2 mm of gingival display Class 3. Average smile line: Dental papilla is visible. Class 4. Low smile line: Gingival margin, dental papilla is not visible at all."
15787323|NCT04553939|Drug|Toripalimab|Toripalimab 3mg/m2 ivgtt, D1 every 14 days for 2-4 cycles.
15787324|NCT04553939|Drug|Gemcitabine|Gemcitabine 800mg/m2 ivgtt, D1 every 14 days for 2-4 cycles.
15787325|NCT04553913|Device|cooling device|device placed on patient in recovery on non surgical side to determine resolution of spinal anesthetics.
15787326|NCT04553900|Diagnostic Test|Transesophageal Echocardiography|Placement of a transesophageal probe and performance of a diagnostic Transesophageal echocardiography examination.
15787327|NCT04553887|Drug|Almonertinib|single agent, 110mg p.o once daily until disease progressed
15787328|NCT04553861|Device|Ambulatory blood pressure monitoring|Every 30 minutes from 7 AM to 10 PM and every 1 hour from 10 PM to 7 AM
15787329|NCT04553861|Device|Galaxy Watch Active2|Every 1 hour by subject (on-demand) from 7 AM to 10 PM and every 5 minutes (automatic) from 10 PM to 7 AM
15787330|NCT04553848|Behavioral|Augmented Reality|Augmented Reality (AR) systems are computer-based applications that allow an individual to view a simulated environment and dynamically interact within this environment in real-time. Augmented reality activities will be chosen by the therapist based on the primary deficits assessed during baseline testing.
15787331|NCT04553848|Behavioral|Treadmill training|The goal of each session will be to increase balance and mobility challenge by increasing speed and minimizing BWS. Appropriate BWS will be chosen at the beginning of each training session. Participants will walk for 1 minute on the treadmill at 30%, 20% and 10% BWS. Maximum walking speed will be determined at each level of BWS and the participant will spend the remainder of the session ambulating with BWS at which they were able to achieve maximum walking speed. Additional BWS will be provided up to 30% of the participant's total body weight if the treating therapist identifies safety concerns or unfavorable gait kinematics. If a safe and kinematically appropriate gait pattern is unable to be achieved at up to 30% BWS, the previously determined walking speed will be reduced to achieve a safe and appropriate walking pattern. Participants will be encouraged not to use upper extremity support while ambulating with BWS.
15787332|NCT04553848|Behavioral|Over ground training/standard of care|"Standard of care interventions to address balance and mobility deficits will be chosen from a list of commonly used interventions in outpatient therapy. The goal of each session will be to increase balance and mobility challenge in an over ground condition focusing treatment in the following areas:
~Biomechanical Constraints
~Stability Limits
~Anticipatory Postural Adjustments
~Reactive Postural Response
~Sensory Orientation
~Stability in Gait"
15787333|NCT04553835|Behavioral|Rhythmic auditory stimulation (RAS) for schizophrenia patients|"A mobile application, metronome beats developed by Stonekick Limited, will be used to give RAS when the participant executes the movement. Before intervention, the participant is required to execute the movement task without the aid of RAS as quickly as possible for 30 seconds, so that we obtain his/her baseline movement tempo (beats per minute). For each 40-minute training session in the first training week, three RAS tempi will be provided for the first, second, and last 10 minutes with a five-minute break in between: normal (100% of the baseline tempo), quick (105% of the baseline tempo), and fast (110% of the baseline tempo). With each training week, the three RAS tempi will be increased by 5%. Schizophrenia patients in the experimental group will undergo upper limb movement training with the aid of RAS. The intervention protocol will last for 3 weeks on the weekday basis (a total of 15 sessions) with one session (40 minutes) per weekday."
15787334|NCT04553835|Behavioral|No RAS for schizophrenia patients|The training protocol will be the same as that used in the experimental group except the lack of RAS during execution of the movement task.
15787335|NCT04553835|Behavioral|RAS for at-risk individuals|"A mobile application, metronome beats developed by Stonekick Limited, will be used to give RAS when the participant executes the movement. Before intervention, the participant is required to execute the movement task without the aid of RAS as quickly as possible for 30 seconds, so that we obtain his/her baseline movement tempo (beats per minute). For each 40-minute training session in the first training week, three RAS tempi will be provided for the first, second, and last 10 minutes with a five-minute break in between: normal (100% of the baseline tempo), quick (105% of the baseline tempo), and fast (110% of the baseline tempo). With each training week, the three RAS tempi will be increased by 5%. At-risk individuals in the experimental group will undergo upper limb movement training with the aid of RAS. The intervention protocol will last for 3 weeks on daily basis (a total of 21 sessions), with one training session (40 minutes) per day."
15787336|NCT04553835|Behavioral|No RAS for at-risk individuals|The training protocol will be the same as that used in the experimental group except the lack of RAS during execution of the movement task.
15787401|NCT04553406|Drug|Open-label SOC|"Clarithromycin 500-1000 mg plus ethambutol HCl 15 mg/kg po once daily or Azithromycin 250-500 mg plus ethambutol HCl 15 mg/k po once daily. Optional rifampin 600 mg or rifabutin 300 mg po once daily may be added to the SOC regimen for up to 28 days.
~Additional SOC treatments may be considered in consultation with the medical monitor."
15787337|NCT04553822|Other|Assisted autogenous drainage group (DAA)|DAA, is used when the patient is not able to perform this technique autonomously and is assisted by the physiotherapist. Its greatest utility is in infants and preschoolers. The technique consists of positioning the patient in a supine position with the head slightly elevated on the supporting plane and then placing both hands around the rib cage and applying bimanual expiratory compression on both hemithoraxes. The physiotherapist must ensure that the child takes 2 to 3 controlled breaths, close to the residual level, with the objective that the expiratory flow displaces the secretions, located distally, towards the central airways.
15787338|NCT04553822|Other|Group prolonged slow expiration (ELPr)|Passive expiratory aid technique applied to the baby by means of a slow thoracic-abdominal pressure that begins at the end of a spontaneous expiration and continues until the residual volume. The physiotherapist through the provoked cough or stimulation of the trachea achieves the expectoration of the sputum.
15787339|NCT04553822|Other|Control group (CG)|Nebulization with 4 ml Muconeb® 3% hypertonic serum, for 8 minutes in a Philips® vibrating mesh nebulizer. Once the nebulization is finished, you will wait 30 minutes in a closed room.
15787340|NCT04553809|Procedure|ENB|ENB for biopsy sampling of peripheral lung lesion
15787341|NCT04553809|Procedure|ENB in combination with rEBUS|The combination of ENB and rEBUS for biopsy sampling of peripheral lung lesions
15787342|NCT04553796|Device|fibroscan|Fibroscan is a non-invasive test that helps assess the health of your liver. Specifically, it uses ultrasound technology to determine the degree of fibrosis or scarring that may be present in your liver from various liver diseases or conditions
15787343|NCT04553770|Drug|Anastrozole|Given PO
15787344|NCT04553770|Procedure|Therapeutic Conventional Surgery|Undergo surgery
15787345|NCT04553770|Biological|Trastuzumab Deruxtecan|Given IV
15787346|NCT04553757|Other|Survey Administration|Complete survey
15787347|NCT04553744|Other|Survey Administration|Complete survey
15787348|NCT04553731|Behavioral|empowerment program with mHealth|empowerment program with mHealth
15787349|NCT04553718|Other|experimental group|provide mHealth program, which has pregnant women using wearable device and app
15787350|NCT04553705|Drug|Omega 3/Nigella Sativa Oil|"Omega-3 supplementation 1000mg contains (300-400mg EPA & 200-300mg DHA)
~Nigella sativa supplementation (1g black seed oil contain 3% thymoquinone"
15787351|NCT04553705|Drug|Omega 3/Nigella Sativa Oil/Indian Costus|"Omega-3 supplementation 1000mg contains (300-400mg EPA & 200-300mg DHA)
~Nigella sativa supplementation (1g black seed oil contain 3% thymoquinone
~Indian Costus supplements"
15787352|NCT04553705|Drug|Omega 3/Nigella Sativa Oil/Quinine pills|"Omega-3 supplementation 1000mg contains (300-400mg EPA & 200-300mg DHA)
~Nigella sativa supplementation (1g black seed oil contain 3% thymoquinone
~Quinine supplementation (1g Quinine)"
15787353|NCT04553705|Drug|Omega 3/Nigella Sativa Oil/Anise seed capsule|"Omega-3 supplementation 1000mg contains (300-400mg EPA & 200-300mg DHA)
~Nigella sativa supplementation (1g black seed oil contain 3% thymoquinone
~Anise seed supplementation (450mg anise seed)"
15787354|NCT04553705|Drug|Omega 3/Nigella Sativa Oil/Deglycyrrhizinated Licorice|"Omega-3 supplementation 1000mg contains (300-400mg EPA & 200-300mg DHA)
~Nigella sativa supplementation (1g black seed oil contain 3% thymoquinone
~Deglycyrrhizinated Licorice 800 mg"
15787355|NCT04553705|Drug|Active Comparator|Standard protocol care of COVID-19 infection
15787356|NCT04553692|Drug|IGM-8444|DR5 Agonist Investigational Drug
15787357|NCT04553692|Drug|FOLFIRI|Chemotherapy Regimen
15787358|NCT04553692|Drug|Bevacizumab (and approved biosimilars)|Targeted Therapy
15787359|NCT04553692|Drug|Birinapant|SMAC-mimetic Investigational Drug
15787360|NCT04553692|Drug|Venetoclax|Targeted Therapy
15787361|NCT04553679|Behavioral|Mindfulness online intervention|A 3-week mindfulness intervention will be offered entirely online. The purpose of the intervention is: 1) to increase participants' mindfulness, and 2) to encourage participants to change their beliefs about the disability associated with stroke to improve their psychological state. Mindfulness refers to the act of being aware: aware of thoughts, aware of emotions, aware of physical sensations, aware of others. The intervention consists of educational texts, daily exercises, audio recordings and videos. Five different topics related to mindfulness will be introduced throughout the intervention.
15787362|NCT04553666|Drug|Epigallocatechin-3-Gallate (EGCG) plus Ascorbic Acid (Vitamin C)|800mg Epigallocatechin-3-Gallate (EGCG) plus 250mg Ascorbic Acid (Vitamin C) taken one time a day for twelve weeks
15787363|NCT04553653|Other|checklist|The checklist will be implemented and healthcare providers use the checklist to manage the patients.
15787364|NCT04553640|Other|Group A/Intervention Curriculum|Virtual patient cases and feedback
15787365|NCT04553640|Other|Group B/Control Curriculum|Online articles on dizziness and emergency department clinical experience
15787366|NCT04553627|Device|ZELTIQ thermoelectric device|This is a feasibility study to determine if cryolipolysis in this area produces a desirable lifted appearance to the buttocks. Typically, a lifted more youthful appearance is obtained through surgical means. Study participants will be recruited from the population of patients who have suitable, treatable subcutaneous fat on the medial infragluteal folds and desire a lifted appearance. Subjects will receive treatments with a cooled cup cryolipolysis applicator from the CoolAdvantage family of applicators (cooled cup vacuum applicator). Treatments will be performed with a treatment temperature of - 11°C for up to 35 minutes. Subjects will complete all study-required follow-up visits, including an 8-week follow-up which may include a second treatment session, as well as a 12-week post final treatment follow-up visit
15787367|NCT04553614|Behavioral|Home-based HIIT|Home-based HIIT uses body-weight equipment free exercises. Participants complete all exercise in their own own at a time of their choosing. This potentially removes many of the barriers preventing at risk-individuals from engaging with the current exercise referral scheme, such as cost, time or intimidating gym environment.
15787368|NCT04553614|Other|Control|Usual exercise referral scheme procedure.
15787369|NCT04553601|Diagnostic Test|18F-FDG PET/CT and PET/CT-guide targeted biopsy in another group of participants|Each subject receive a single intravenous injection of 18F-FDG PET/CT and PET/CT-guide targeted biopsy within the specified time
15787370|NCT04553588|Other|Disposal pouch|Medication Disposal Pouch
15787371|NCT04553575|Biological|serology|biological blood samples withdrawn at 6, 12 and 24 months
15787402|NCT04553393|Drug|Chidamide|Chidamide will be added 1 month after responding to CART cells infusion
15787372|NCT04553562|Device|Acupuncture|Sterile adhesive pads will be placed after skin disinfection on the acupoints. Guanyuan (CV4)，Qihai (CV6)，bilateral Sanyinjiao (SP6), Yinbao (LR9), Qixue (KI13) and Fujie (SP14) will be inserted through the pads by the needles (0.30mm in diameter, 40 mm in length, Hwato Brand, Suzhou Medical Appliance Factory, China) to a depth of 25-30mm. Yintang (GV4) will be inserted through the pads by the needle (0.30mm in diameter, 25mm in length, Hwato Brand, Suzhou Medical Appliance Factory, China) to a depth of 10-15mm. The needles at all points will be lightly lifting, thrusting, and twirling every 10 minutes during each session with the sensation of sourness, achiness, heaviness and numbness (deqi). The participants will be treated three times a week, on alternate days (ideally), for 6 successive weeks; 18 sessions for each patient in total.
15787373|NCT04553562|Device|Sham acupuncture|Sterile adhesive pads will be placed after skin disinfection on the acupoints. Needles (0.30 mm in diameter, 25 mm in length) with a blunt tip will be inserted at the Guanyuan (CV4)，Qihai (CV6)，bilateral Sanyinjiao (SP6), Yinbao (LR9), Qixue (KI13) and Fujie (SP14) without penetrating the skin. The participants will be treated three times a week, on alternate days (ideally), for 6 successive weeks; 18 sessions for each patient in total.
15787374|NCT04553549|Device|Transradial approach|"Patients who are undergoing endovascular intervention will be enrolled into the study. As the metrics analyzed in this study are already normally collected, this study can be considered as a secondary use of the data. The procedure will be done using standard criteria as per operator preference. All interventional cases at the study institution undergo a radial first approach, meaning that the access site of choice is the radial artery. The investigators will measure the radial artery size to ensure that the artery is greater than 2.4 mm in order to use the Infinity catheter (8Fr)."
15787375|NCT04553536|Drug|Esketamine, Sulfentanil or/and Remifentanil|The esketamine or the opioids will be intravenously injected or infused to the patients with propofol and one of the muscle relaxants to induce and maitain general anesthesia.
15787376|NCT04553523|Device|Hydrus Microstent|The Hydrus Microstent is a crescent-shaped nitinol device intended to be a permanent implant placed through the trabecular meshwork into Schlemm's canal, immediately following placement of a monofocal IOL
15787377|NCT04553510|Drug|Bevacizumab and steroid|Bevacizumab 5mg / kg, once every two weeks, a total of 6 weeks of 4 courses, sequential prednisone 10mg / d orally, the total course of 12 weeks.
15787378|NCT04553510|Drug|Bevacizumab and placebo|Bevacizumab 5mg / kg, once every two weeks, a total of 6 weeks of 4 courses, sequential placebo 2 pills per day orally, the total course of 12 weeks.
15787379|NCT04553497|Device|Interferential current|"Interferential current or sham were applied to the patients before the each exercise session. Pre-modulated bipolar method with the currier frequency of 4 kHz by a combination therapy unit (Sonopuls 692, Enraf-Nonius) with two electrodes (8×6 cm) was used. One electrode was placed on the lateral part of the deltoid muscle; the other was placed on the trapezium muscle close to the shoulder. Subjects were told that in order to produce an effect, the intensity of the stimulator must be maintained at a strong but comfortable level at all times. The sham interferential current therapy consisted of the placement of the same pads for the same time but no electrical stimulation was applied to the probes."
15787380|NCT04553497|Other|Rehabilitation program|Rehabilitation program carried out under the guidance of same physiotherapist 3 times a week for 6 weeks. First phase of the rehabilitation (0-3 weeks) began with elbow, wrist and hand active range of motion (ROM) and pendulum (clockwise and counter clockwise) exercises in the 0-2 weeks of the nondisplaced fracture. During second phase (3-6 weeks), active forward elevation in supine were carried out, and then progressed to sitting and standing position. At the end of 6 weeks', the physiotherapist described the home training program involving the resistance exercises by using therabands of progressive strengths for internal and external rotation, flexion, extension and abduction. Flexibility and stretching exercises were also given to progressively increase ROM in all directions. At each visit, the patients were instructed to regularly perform their exercises.
15787381|NCT04553484|Diagnostic Test|Measuring cardiovascular performance and blood flow|Measuring cardiovascular performance and blood flow
15787382|NCT04553471|Radiation|Stereotactic body radiotherapy|Treatment will take approximately 2 weeks.
15787383|NCT04553471|Procedure|Research blood draw|-Baseline, immediately after radiotherapy completion (fraction 5), 14 days after radiotherapy, and 30 day follow-up
15787384|NCT04553458|Device|Radiofrequency ablation|Radiofrequency ablation of the tumour
15787385|NCT04553458|Drug|Trance-arterial chemoembolization|Trance-arterial chemotherapy
15787386|NCT04553458|Procedure|Liver resection|non-anatomical or anatomical liver resection
15787387|NCT04553458|Combination Product|Combined radiofrequency ablation + percutaneous ethanol injection|combined therapy
15787388|NCT04553458|Drug|Percutaneous ethanol injection|Percutaneous ethanol injection of HCC
15787389|NCT04553458|Drug|Systemic chemotherapy|Systemic chemotherapy
15787390|NCT04553458|Drug|Sorafenib|Sorafenib
15787391|NCT04553458|Dietary Supplement|Viscum|Viscum for HCC
15787392|NCT04553458|Drug|Symptomatic treatment|Symptomatic treatment
15787393|NCT04553445|Behavioral|Chronotype|Participants screened using the Morningness/Eveningness Questionnaire. Chronotype categorized as either Definite Morning/Morning, or Evening/Definite Evening. Participant will exercise (60-70% estimated heart rate max, 2 x per week, 30-min/session) either in sync or not in sync with chronotype for one month in a randomized cross-over design. There will be a one-month wash out period, and then participant will complete training in the alternate chronotype for one month.
15787394|NCT04553445|Behavioral|Green exercise|Participants will be randomly assigned to four weeks of moderate intensity aerobic exercise (60-70% estimated heart rate max, 2 x per week, 30-min/session) in either natural or indoor environments in a randomized cross-over design. There will be a one-month wash out period, and then participant will complete training in alternate environment for one month.
15787395|NCT04553432|Device|Amniotic membrane Omnigen[TM]|17mm circular disk of processed amniotic tissue donated by mother after birth with a 6mm laser cut aperture to allow unimpeded vision https://www.nu-vision.co.uk/omnigen
15787396|NCT04553432|Device|Bandage soft Contact Lens OmniLenz[R]|18mm soft silicone-hydrogel contact lens https://www.nu-vision.co.uk/omnilenz
15787397|NCT04553419|Drug|Cephalexin|Cephalexin capsule: TEVA Cephalexin Cephalexin suspension: LUPIN Cephalexin
15787398|NCT04553419|Drug|Placebo|Cellulose capsules or suspension
15787399|NCT04553406|Drug|SPR720|250 mg capsules
15787403|NCT04553393|Drug|Decitabine|Decitabine will be added 1 month after responding to CART cells infusion
15787404|NCT04553393|Drug|Chidamide and Decitabine|Both chidamide and decitabine will be added 1 month after responding to CART cells infusion
15787405|NCT04553393|Biological|Decitabine-primed Tandem CAR19/20 engineered T cells|Tandem CAR19/20 engineered T cells
15787406|NCT04553380|Drug|basic insulin|"Initial dose of basic insulin: 0.2U/kg/d.
~Dose titration regimens: the dose is titrated by increments of 0.07U/kg daily until the fasting blood glucose（FBG）≤7 mmol / L, and if the FBG≤ 3.9mmol/L, the 0.07U/kg is reduced.
~Injection time: subcutaneous injection before going to bed every night."
15787407|NCT04553367|Drug|Meropenem|all patients in both groups receive meropenam and put on the ventilators for 2 weeks
15787408|NCT04553367|Procedure|bronchoscopy|Only patients of group B had three times bronchoscopy according to our protocol one at the end of first 5 days, second bronchoscopy at the end of the second 5 days and last one at the end of the studied period
15787409|NCT04553367|Device|ventilator|ventilator
15787410|NCT04553354|Procedure|cortical resections|is the removal of the epileptic focus either temporal or extra temporal area
15787411|NCT04553341|Device|Navigated repetitive transcranial magnetic stimulation|In these patients we will apply the following protocol: after the initial nTMS mapping of the according function, patients will be stimulated on 20 consecutive days by a series of rTMS pulses. The frequencies (1-20 Hz), number of pulses (100-1,000), and stimulation intensities (50-130% resting motor threshold = rMT = individual lowest stimulation intensity that evokes positive muscle responses) will be applied in dependency of the individual patients comfort and the evoked effect. Stimulations will be applied to the eloquent brain region, which is infiltrated by the tumor.
15787412|NCT04553328|Device|Us guided nerve blocks|The ILIH nerves were identified and located in the fascia compartment between the internal oblique and the transverse abdominis or external oblique muscles, a 20 G needle was advanced between the aponeurosis of the internal oblique and transverses abdominis muscles then 30 ml bupivacaine 0.25% was injected with intermittent aspiration,then 10 ml bupivacaine 0.25% was injected around the nerves.
15787413|NCT04553315|Procedure|chest expansion exercises|Chest mobility exercises with Incentive spirometer and segmental breathing exercise ) and breath stacking technique e.
15787414|NCT04553302|Other|This study does not contain any intervention.|This study does not contain any intervention.
15787415|NCT04553289|Other|exercising into pain|the intervention consists in 4 strength exercises: one will be performed into pain (ranging between 4 and 7 on NPRS scale) and the rest between 0 adn 2 on a NPRS scale
15787416|NCT04553289|Other|exercising with no/slight pain|the intervention consists in 4 strength exercises and all of them will be performed in no pain/slight pain (between 0 and 2 on NPRS scale)
15787417|NCT04553263|Drug|Contrave 8Mg-90Mg Extended-Release Tablet|Naltrexone HCl/Bupropion HCl is an FDA-approved weight-loss medication with efficacy via the mesolimbic dopamine system to reduce hunger and help control cravings.
15787418|NCT04553263|Drug|Bupropion|Bupropion is FDA-approved and marketed both as an antidepressant agent (Wellbutrin®) and treatment for smoking cessation (Zyban®) and has shown efficacy in reducing symptoms of depression and drug craving in stimulant users. it is also a promising candidate to improve cognition function.
15787419|NCT04553250|Procedure|Doubled-stapled colorectal anastomosis|Anastomosis performed between the colon an the rectal stump, using a double-stapled technique.
15787420|NCT04553224|Other|Clinical evaluations|SCORAD and target SCORAD
15787421|NCT04553224|Other|Non-invasive instrumental measurements|TEWL, cutaneous hydration, skin lipidic analysis, colorimetry, hydration index
15787422|NCT04553224|Other|Subject's evaluations|PO-SCORAD, target PO-SCORAD and subject's questionnaire
15787423|NCT04553211|Behavioral|EPT|Expedited Partner Therapy (EPT) involves provision of empiric oral antibiotic therapy to the recent sexual partners of an individual diagnosed with gonorrhea and/or chlamydia infection.
15787424|NCT04553198|Behavioral|Backward Locomotion Treadmill Training (BLTT)|9-training sessions of reverse treadmill training (no bodyweight support)over three weeks.
15787425|NCT04553185|Other|Study procedure|All participants will undergo a collection of demographic data, personal and family history for PD, a neurological examination and administration of clinical scales. All participants will undergo a collection of venous blood sample. At the end of the visit they will receive a wristwatch to monitor their sleep at home (Actigraph) and a sleep diary, together with a prepaid envelope to post the watch and the diary back to the investigators. They will also receive a link for a series of online tests for non-motor symptoms related to Parkinson's disease that they can complete remotely at home.
15787426|NCT04553159|Biological|Autologous adipose derived stem cells|Once consented, tumescent liposuction will be performed and 100-300ml of lipoaspirate will be collected. The harvested lipoaspirate will be processed aseptically in theatre through centrifugation at 1200g, then the sediment will be washed with Phosphate buffered saline and then incubated at 37 degrees celsius in 0.075% Collagenase type 1a for 1 hour. This will then be washed in an equal volume of 10% Fetal Bovine Serum then filtered through a 100 micrometer cell strainer. Red cells lysed using the Red cell lysis buffer will be performed followed by washing in Phosphate buffered Saline and centrifugation and the stromal vascular fraction cell pellet collected and diluted into 5ml normal saline solution for immediate infiltration. cell counts and viability using Trypan blue will be perfomed prior to the infiltration
15787427|NCT04553146|Procedure|Immediate implantation in posterior region with alveolar ridge preservation combined with sealing socket abutment|Twenty BLXⓇ Straumann immediate implants were placed flapless. The gap around the implant was filled with xenogeneic biomaterial. An intra-oral scanner was performed and sent to the dental laboratory to digitally design a customized healing abutment. The abutment was then milled from a block of PEEK and placed a couple of hours later in the clinic. Three months after implantation, the abutment was removed and the final monolithic crown based on the initial IOS was placed. The transmucosal design from the SSA was replicated on the final crown.
15787428|NCT04553133|Drug|PF-07104091 monotherapy dose escalation|PF-07104091 will be administered orally
15787429|NCT04553133|Drug|PF-07104091 + palbociclib + fulvestrant|PF-07104091 will be administered orally in combination with palbociclib and fulvestrant
15787430|NCT04553133|Drug|PF-07104091 + palbociclib + letrozole|PF-07104091 will be administered orally in combination with palbociclib and letrozole
15787431|NCT04553133|Drug|PF-07104091 monotherapy dose expansion (ovarian)|PF-07104091 will be administered orally
15787432|NCT04553133|Drug|PF-07104091 monotherapy dose expansion (SCLC)|PF-07104091 will be administered orally
15787433|NCT04553133|Drug|PF-07104091 monotherapy dose expansion (TNBC)|PF-07104091 will be administered orally
15787434|NCT04553133|Drug|PF-07104091 + palbociclib + fulvestrant (post CDK4/6)|PF-07104091 will be administered orally in combination with palbociclib and fulvestrant
15787435|NCT04553133|Drug|PF-07104091 + palbociclib + fulvestrant (CDK4/6 naive)|PF-07104091 will be administered orally in combination with palbociclib and fulvestrant
15787436|NCT04553133|Drug|PF-07104091 + palbociclib + letrozole (CDK4/6 naive)|PF-07104091 will be administered orally in combination with palbociclib and fulvestrant
15787437|NCT04553120|Behavioral|Alternating single stimulus and multiple stimuli|"P-ARET for cockroach phobia alternating between two interventions: exposure to a single stimulus (always using the same projected cockroach) and exposure to multiple stimuli (different cockroaches in terms of number, shape, colour and movement). It will be counterbalanced to start the same number of participants in each of the two modalities. The two conditions will be randomly applied for each participant, with the restriction of that each condition will be applied 3 times.
~There will be 6 weekly sessions of approximately 1 hour. The purpose of this exposure treatment is to confront patients to the phobic stimuli in a controlled manner, which favors the habituation process and allows them to accept that the negative consequences they fear do not actually occur. All exposure sessions should be recorded (patients will sign informed consent for recording prior to treatment initiation)."
15787438|NCT04553107|Behavioral|Deprescribing Intervention|An individualized deprescribing intervention will be created by a pharmacist working with a patient to identify harmful, costly, and unnecessary medications to be reduced. The intervention will include a plan and monitoring for up to 3 months to reduce medication use.
15787439|NCT04553107|Behavioral|Usual Care|The usual care arm will receive the current standard of care, which includes medication reconciliation by a clinic nurse at the time of their appointment. Nurses review all medications and answer medication-related questions, and refer medication questions to the healthcare provider for further discussion when necessary.
15787440|NCT04553094|Other|Endurance training|Aerobic circuit training
15787441|NCT04553094|Other|Muscle building training|Muscle strengthening circuit training
15787442|NCT04553081|Drug|Dual versus triple therapy in treatment of HIV-1 infection.|cfr arm decsription
15787445|NCT04553055|Other|online questionnaires|questionnaire (with detailed questions including how/when/which/for how long antibiotics are prescribed)
15787446|NCT04553042|Drug|Seltorexant|Seltorexant will be administered orally as per assigned treatment sequence.
15787447|NCT04553029|Other|No intervention|This is a cross-sectional survey study evaluating prevalence, severity and associated factors in women with moderate-to-severe menopause-related vasomotor symptoms (MR-VMS).
15787448|NCT04553016|Biological|Vaccine|IM vaccination with ChAdOx1.tHIVconsv1, MVA.tHIVconsv3 and MVA.tHIVconsv4
15787449|NCT04553016|Biological|Placebo|IM administration of 0.9% sterile sodium chloride solution
15787450|NCT04553003|Drug|Glucocorticoids+hepatoprotectant|Participants received glucocorticoids (0.4mg/kg/d po.) and hepatoprotectant for 7 days.
15787451|NCT04553003|Drug|hepatoprotectant|Participants received hepatoprotectants (i.v.gtt.) for 7 days.
15787452|NCT04552990|Drug|Jet injection of ALA|The Basal Cell Carcinoma/BCC tumor and a 5 mm margin will be injected with a grid of 80 microliters of 20% ALA at 5-8.5 mm between each injection (30-50% overlap).
15787453|NCT04552990|Procedure|Surgical excision|In the first 4 patients, the tumor will be excised according to national guidelines after 3h incubation (+/- 30 min is accepted).
15787454|NCT04552990|Procedure|Illumination|For patients 5-16,after 3h incubation (+/- 30 min), the tumor will be illuminated with red light corresponding to a dose of 75 J/cm2 570- 670 nm or equivalent dose of narrowband red light. The intervention will be repeated at after 14 days in patient 5-16. If the wound is not healed at two weeks, the treatment may be postponed to allow healing (patient 5-16).
15787455|NCT04552990|Other|Incubation|After injection of ALA, the tumor will be occluded with a light proof dressing and incubated for 3h (+/- 30 min).
15787456|NCT04552977|Drug|fluzoparil|a PARP1 inhibitor
15787457|NCT04552977|Drug|temozolomide|an alkylating chemotherapeutic agent
15787458|NCT04552964|Other|Single arm|Far Best Corrected Visual Acuity (BCVA) ; Intra-Ocular Pressure (IOP) assessment ; Fundus examination ; Automated visual field ; Slit lamp examination ; Pregnancy test ; Patient Satisfaction Questionnaire
15787459|NCT04552951|Drug|Cholecalciferol|Single doe of 100.000 IU
15787460|NCT04552938|Other|pre-LVA|Venous serum samples were collected from patients before LVA.
15787461|NCT04552938|Other|post-LVA|Venous serum samples were collected from patients one-month after LVA.
15787462|NCT04552925|Other|Rehabilitation|Exercises and rehabilitation for massive rotator cuff tears
15787466|NCT04552886|Biological|TH-1 Dendritic Cell Immunotherapy|Adult patients with histopathologically diagnosed glioblastoma will be eligible for this novel, personalized dendritic cell vaccine after completing standard of care chemoradiation.
15787467|NCT04552873|Drug|Urea|"the experimental group will be treated during 5 days by urea dose per administration : 1g / kg / 24 hours in 2 or 3 doses morning, noon and evening (dose adjustment of urea according to weight)
~If hyponatremia persists beyond D8 after initiation of the study treatment (urea or placebo), that is to say after the date of the collection of the primary endpoint, it will be possible to introduce corticosteroids (fludrocortisone or others). These treatments will be collated.
~If during patient monitoring the serum sodium exceeds 145 mmol / L, treatment should no longer be administered."
15787468|NCT04552873|Other|PLACEBO|the control group will be treated during 5 days by ergytonyl dose per administration : 5mL
15787469|NCT04552860|Behavioral|Emotional Awareness and Expression Therapy|Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.
15787470|NCT04552847|Drug|Al18F-NOTA-octreotide|One intravenous injection of 4 MBq/kg
15787471|NCT04552847|Device|PET/CT|Patients in part A of the trial will undergo a whole-body PET/CT scan 120 minutes (acceptable range: 105 - 240 minutes) after injection of the tracer. The CT-scan is a low-dose CT that will be acquired for both PET attenuation correction and anatomical information.
15787472|NCT04552847|Device|PET/MR|Patients in part B of the trial will undergo a whole-body PET/MR scan 120 minutes (acceptable range: 105 - 240 minutes) after injection of the tracer. The MR scan is a fully diagnostic MR requiring intravenous contrast (Dotarem®) injection and Buscopan® administration to minimize bowel movement.
15787473|NCT04552808|Drug|Yimitasvir Phosphate|Cohort A: On the first day, 100 mg of Yimitasvir phosphate was given in a single dose on fasted by each subjects
15787474|NCT04552808|Drug|Yimitasvir Phosphate|Cohort B: were subjects with moderate liver function impairment. On the first day, 100 mg of Yimitasvir phosphate was given in a single dose on fasted by each subjects.
15787475|NCT04552808|Drug|Yimitasvir Phosphate|Cohort C: Cohort C are healthy subjects, cohorts C and D, should be matched in terms of sex, age, and body mass index (BMI). On the first day, 100 mg of Yimitasvir phosphate was given in a single dose on fasted by each subjects.
15787476|NCT04552808|Drug|Yimitasvir Phosphate|Cohort D: were subjects with severe liver function impairment. On the first day, 100 mg of Yimitasvir phosphate was given in a single dose on fasted by each subjects.
15787477|NCT04552795|Drug|3TC|12 subjects will be administered 3TC, 300mg once daily, via an oral tablet for 24 weeks.
15787478|NCT04552782|Behavioral|Alcohol CBM|Trains approach or avoidance responses to alcohol cues.
15787479|NCT04552782|Behavioral|PTSD CBM|Trains approach or avoidance responses to trauma cues.
15787480|NCT04552782|Behavioral|Alcohol Sham|Will not train approach or avoidance responses.
15787481|NCT04552782|Behavioral|PTSD Sham|Will not train approach or avoidance responses.
15787482|NCT04552769|Drug|Abemaciclib|200 mg orally
15787483|NCT04552756|Diagnostic Test|Seizure Diary|"The patients keep a seizure diary during the period of radiotherapy and up to 6 weeks following radiotherapy. Every day, the patients document the number (and type) of seizures and intake of anti-epileptic medication. The seizure diary will be used to assess the rate of patients with progression of seizure events during the course of radiotherapy compared to baseline.
~To obtain an objective assessment of seizure activity in addition to patient reported outcomes, an electroencephalography (EEG) is performed during the first and the sixth week of radiotherapy, as well as during the sixth week following radiotherapy. Activity typical for epilepsy includes spike waves, sharp waves and/or sharp slow waves and is classified as absent or present."
15787484|NCT04552743|Drug|MGTA-145|MGTA-145 investigational agent will be provided by Magenta Therapeutics. MGTA-145 will be administered as an IV infusion over 3 to10 minutes, as clinically indicated.
15787485|NCT04552743|Drug|Plerixafor|Plerixafor (0.24 mg/kg) will be administered subcutaneously. Plerixafor dose will be reduced to 0.16 mg/kg in patients with renal dysfunction per package insert
15787486|NCT04552730|Drug|Cenegermin-Bkbj|Topical Cenegermin-bkbj 6 times per day for 8 weeks.
15787487|NCT04552717|Other|My Grief|The app will build on principles of cognitive behavioural theory and therapy (CBT) and contains four main sections: Learning, Self-assessment, Manage symptoms and Find support.
15787488|NCT04552704|Biological|CD24 Extracellular Domain-IgG1 Fc Domain Recombinant Fusion Protein CD24Fc|Given IV
15787489|NCT04552704|Drug|Placebo Administration|Given IV
15787490|NCT04552691|Drug|Pegunigalsidase Alfa|Pengunigalsidase alfa is a recombinant ERT (enzyme replacement therapy) used to treat Fabry disease (dosage: 1 mg/kg body weight every 2 weeks).
15787491|NCT04552678|Behavioral|Healthy Eating, Active Play, Self-Regulation, Parent Education|In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Healthy Eating curriculum, an 11-lesson Active Play curriculum, and an 11-lesson Self-Regulation curriculum. Parents will receive access to web-based resources on food literacy, and will be invited to complete 18 web-based education modules on topics including improving household routines, managing children's behaviors and emotions, improving children's sleep patterns, improving access to healthy foods, healthy meal and snack preparation, modeling healthy eating and activity behaviors, and improving family activity patterns.
15787492|NCT04552678|Behavioral|Healthy Eating, Active Play, Self-Regulation|In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Healthy Eating curriculum, an 11-lesson Active Play curriculum, and an 11-lesson Self-Regulation curriculum. Parents will receive access to web-based resources on food literacy.
15787493|NCT04552678|Behavioral|Healthy Eating, Active Play, Parent Education|In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Healthy Eating curriculum, and an 11-lesson Active Play curriculum. Parents will receive access to web-based resources on food literacy, and will be invited to complete 18 web-based education modules on topics including improving household routines, managing children's behaviors and emotions, improving children's sleep patterns, improving access to healthy foods, healthy meal and snack preparation, modeling healthy eating and activity behaviors, and improving family activity patterns.
15787494|NCT04552678|Behavioral|Healthy Eating + Active Play|In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Healthy Eating curriculum, and an 11-lesson Active Play curriculum. Parents will receive access to web-based resources on food literacy.
15787495|NCT04552678|Behavioral|Healthy Eating, Self-Regulation, Parent Education|In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Healthy Eating curriculum, and an 11-lesson Self-Regulation curriculum. Parents will receive access to web-based resources on food literacy, and will be invited to complete 18 web-based education modules on topics including improving household routines, managing children's behaviors and emotions, improving children's sleep patterns, improving access to healthy foods, healthy meal and snack preparation, modeling healthy eating and activity behaviors, and improving family activity patterns.
15787496|NCT04552678|Behavioral|Healthy Eating + Self-Regulation|In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Healthy Eating curriculum, and an 11-lesson Self-Regulation curriculum. Parents will receive access to web-based resources on food literacy.
15787497|NCT04552678|Behavioral|Healthy Eating + Parent Education|In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Healthy Eating curriculum. Parents will receive access to web-based resources on food literacy, and will be invited to complete 18 web-based education modules on topics including improving household routines, managing children's behaviors and emotions, improving children's sleep patterns, improving access to healthy foods, healthy meal and snack preparation, modeling healthy eating and activity behaviors, and improving family activity patterns.
15787498|NCT04552678|Behavioral|Healthy Eating Only|In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Healthy Eating curriculum. Parents will receive access to web-based resources on food literacy.
15787499|NCT04552678|Behavioral|Active Play, Self-Regulation, Parent Education|In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Active Play curriculum, and an 11-lesson Self-Regulation curriculum. Parents will receive access to web-based resources on food literacy, and will be invited to complete 18 web-based education modules on topics including improving household routines, managing children's behaviors and emotions, improving children's sleep patterns, improving access to healthy foods, healthy meal and snack preparation, modeling healthy eating and activity behaviors, and improving family activity patterns.
15787500|NCT04552678|Behavioral|Active Play + Self-Regulation|In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Active Play curriculum, and an 11-lesson Self-Regulation curriculum. Parents will receive access to web-based resources on food literacy.
15787501|NCT04552678|Behavioral|Active Play + Parent Education|In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Active Play curriculum. Parents will receive access to web-based resources on food literacy, and will be invited to complete 18 web-based education modules on topics including improving household routines, managing children's behaviors and emotions, improving children's sleep patterns, improving access to healthy foods, healthy meal and snack preparation, modeling healthy eating and activity behaviors, and improving family activity patterns.
15787502|NCT04552678|Behavioral|Active Play Only|In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Active Play curriculum. Parents will receive access to web-based resources on food literacy.
15787503|NCT04552678|Behavioral|Self-Regulation + Parent Education|In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Self-Regulation curriculum. Parents will receive access to web-based resources on food literacy, and will be invited to complete 18 web-based education modules on topics including improving household routines, managing children's behaviors and emotions, improving children's sleep patterns, improving access to healthy foods, healthy meal and snack preparation, modeling healthy eating and activity behaviors, and improving family activity patterns.
15787504|NCT04552678|Behavioral|Self-Regulation Only|In addition to a 27-lesson, core food literacy curriculum that children across all conditions will receive, children in this condition will also be exposed to an 11-lesson Self-Regulation curriculum. Parents will receive access to web-based resources on food literacy.
15787505|NCT04552678|Behavioral|Food Literacy + Parent Education|Children in this condition will only receive a 27-lesson, core food literacy curriculum (children across all conditions will receive this curriculum). Parents will receive access to web-based resources on food literacy, and will be invited to complete 18 web-based education modules on topics including improving household routines, managing children's behaviors and emotions, improving children's sleep patterns, improving access to healthy foods, healthy meal and snack preparation, modeling healthy eating and activity behaviors, and improving family activity patterns.
15787506|NCT04552678|Behavioral|Food Literacy Only|Children in this condition will only receive a 27-lesson, core food literacy curriculum (children across all conditions will receive this curriculum). Parents will receive access to web-based resources on food literacy.
15787507|NCT04552665|Device|KODEX-EPD system|To evaluate the performance of the KODEX-EPD system and collect procedural data and medical images for Philips' internal research and development activities (R&D)
15787508|NCT04552652|Behavioral|High-Intensity Interval Training|Remotely monitored exercises will be performed at home. The high-intensity interval group warms-up for 5 minutes at moderate intensity (65-75% of maximal heart rate). After warm-up exercise, will continue in 4 minutes intervals at high-intensity to reach the target zone (85-95% of maximal heart rate) Each interval will be separated by 3 minutes of active recoveries (at 65-75% of maximal heart rate). The session ends with a 3-minute cool-down phase. Overall training exercise time will be 33 minutes - isocaloric compared to moderate-intensity continous training group. All participants will train using a heart rate monitor during each workout.
15787509|NCT04552652|Behavioral|Moderate-intensity continuous training|Remotely monitored exercises will be performed at home. Patients in the moderate-intensity continuous training group will perform a 41-minute constant workout with an intensity of 65-75% of maximum heart rate, representing the same total training load as the high-intensity aerobic exercise group. All participants will train using a heart rate monitor during each workout.
15787510|NCT04552639|Behavioral|Newbridge Eating disorders Activity Treatment group|A compulsive exercise cognitive-behavioural based group, for children and adolescents diagnosed with an eating disorder. It was devised for eating disorders including Anorexia Nervosa, Bulimia Nervosa and Other Specified Feeding or Eating Disorder. This treatment is semi-structured and problem-oriented, which focuses on tackling the factors and processes that maintain compulsive exercise behaviour.
15787511|NCT04552639|Behavioral|Newbridge House treatment as usual|Multi-disciplinary eating disorder treatment (including; psychiatry, individual therapy, group therapy, dietetic support, occupation therapy and nursing excluding NEAT group).
15787664|NCT04551521|Drug|Atezolizumab|1200 mg in the first cycle, followed by 840 mg every 3 weeks
15787512|NCT04552626|Behavioral|Prolonged sitting (social breaks)|Participants are required to sit for 80 minutes doing schoolwork, with a toilet break in between. Every twenty minutes participants will have a short social break. Test day begins at 8:00 with pretest measures, followed by the intervention at about 9:00, which will end around 12:00, with subsequent posttest measures.
15787513|NCT04552626|Behavioral|Prolonged sitting with step-up exercise break|Participants are required to sit for 80 minutes doing schoolwork, with a toilet break in between. Every twenty minutes participants will have a physical activity break, where they will perform a simple moderate-intensity step-up exercise for three minutes at a predetermined pace. Test day begins at 8:00 with pretest measures, followed by the intervention at about 9:30, which will end around 12:00, with subsequent posttest measures.
15787514|NCT04552626|Behavioral|Prolonged sitting with simple resistance activity breaks|Participants are required to sit for 80 minutes doing schoolwork, with a toilet break in between. Every twenty minutes participants will have a physical activity break, where they will perform simple resistance activities following a video for about three minutes. Test day begins at 8:00 with pretest measures, followed by the intervention at about 9:30, which will end around 12:00, with subsequent posttest measures.
15787515|NCT04552613|Drug|EGFR-TKI|(A) Standard programme group, EGFR-TKI targeted therapy;
15787516|NCT04552613|Drug|EGFR-TKI combined with chemotherapy (pemetrexed plus carboplatin)|(B) controlled programme group, EGFR-TKI targeted therapy combined chemotherapy(pemetrexed plus carboplatin for 4 cycles )
15787517|NCT04552600|Drug|Nuvastatic|Phase 1b Interventional, multi-centered, double-masked, randomized
15787518|NCT04552600|Other|Placebo|Phase 1b Interventional, multi-centered, double-masked, randomized
15787519|NCT04552587|Behavioral|Heart APP|The HEART intervention includes a care planning visit for patients and caregivers and an App for caregivers focused on nutrition, self-care and support.
15787520|NCT04552574|Dietary Supplement|HMR(Home meal replacement)-type omega-3-balanced diet|A diet of which omega-3 to omega-6 ratio is below 1:4 was developed by Agricultural entity Green Grass Co., Ltd.. A committee of experts that is composed of several university professors in authorities of IPET(Institute of Planning and Evaluation for Technology in food, agriculture and forestry) also participated in the development of this diet.
15787521|NCT04552561|Behavioral|My MS Toolkit|My MS Toolkit, a web-based self-management intervention designed to help persons with Multiple Sclerosis self-manage fatigue, pain, and depressed mood.
15787522|NCT04552548|Other|regional nerve block|Abdominal field blocks have been used in anesthesia for surgery involving the anterior abdominal wall with ultrasound-guided technique. TAP block is a regional anesthetic technique that blocks neural afferents of the anterolateral abdominal wall. Using anatomical landmark guidance or with the aid of ultrasound (US), local anesthetic is injected into the transversus abdominis fascial plane, where the nerves from T6 to L1 are located. Ultrasound-guided quadratus lumborum (QL) block is considered now as one of the novel truncal abdominal blocks, as it is effective in preventing somatic pain associated with upper and lower abdominal surgeries.
15787523|NCT04552535|Drug|Second line (2L) afatinib|Afatinib
15787524|NCT04552535|Drug|Second line chemotherapy|Chemotherapy
15787525|NCT04552522|Other|shrimp allergy with intend to eat shrimp|shrimp allergy with intend to eat shrimp and treat with oral immunotherapy
15787526|NCT04552509|Radiation|Stereotactic Body Radiotherapy|Treatment of prostate cancer with stereotactic body radiation therapy (SBRT)
15787527|NCT04552483|Drug|Nitazoxanide|Nitazoxanide 500mg 8/8 hours for 5 days in the early clinical phase of COVID-19.
15787528|NCT04552483|Drug|Placebo|Placebo 8/8 hours for 5 days in the early clinical phase of COVID-19.
15787529|NCT04552470|Drug|Placebo|3 matching placebo tablets taken twice a day (BID)
15787530|NCT04552470|Drug|PF-06882961|Participants will be randomized to one of 3 active doses (40, 80, or 120 mg), taking 3 tablets twice daily for 8 weeks.
15787531|NCT04552457|Behavioral|No activity restrictions|"Patients in the No activity restrictions group will be allowed to return to their normal activity immediately."
15787532|NCT04552457|Behavioral|Activity restrictions|"Patients in the Activity restrictions group will not be allowed to perform strenuous exercise or lift anything greater than 10lbs. Strenuous exercise will be defined as is any activity that requires so much exertion that one cannot have a conversation comfortably while doing it."
15787533|NCT04552444|Drug|Biapenem|In the course of CRKP treatment, double dose biapenem was selected.
15787534|NCT04552431|Drug|Ciprofloxacin|Ciprofloxacin, 500 mg twice daily
15787535|NCT04552431|Drug|Tamsulosin Hydrochloride|Tamsulosin Hydrochloride, 0.4 mg once daily
15787536|NCT04552431|Drug|Tamsulosin Hydrochloride Placebo|Tamsulosin Hydrochloride Placebo (Placebo-TH) one tablet once daily
15787537|NCT04552431|Drug|Ciprofloxacin placebo|Ciprofloxacin placebo (Placebo-CF) one tablet twice daily
15787538|NCT04552418|Drug|Potato starch|Starting 5-7 days before treatment with dual-ICI, participant will consume 20g of potato starch (Bob's Red Mill®) once a day for 3 days, then increase to 20g twice a day, continuing throughout dual-ICI treatment (total duration approximately 13 weeks).
15787539|NCT04552405|Dietary Supplement|Anti-inflammatory Diet|FAP individuals followed for 3 months a low-inflammatory diet
15787540|NCT04552392|Other|No intervention|No intervention
15787541|NCT04552379|Biological|Peginterferon beta-1a|"Administration of trial drug: PLEGRIDY is given by an injection under the skin (subcutaneous injection). It will be administered to participants in accordance with product insert instructions by appropriately trained trial staff for whom administration of subcutaneous injections is within their normal scope of practice (e.g. RN or MD). They will wait for 20 mins after the last individual receives the interferon before leaving a residence. Administering staff will be supplied with appropriate PPE, trained in the use of this equipment and protocols for infection control, and will always attend in pairs.
~PLEGRIDY will be administered in the home of the participants. Due to the heat-labile nature of the trial product (storage required at ~4oC) a verified English Spanish version of the product label will be printed by a GMP certified company and applied to the product and patient band just at the time of use."
15787542|NCT04552366|Biological|Ad5-nCoV|Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)
15787543|NCT04552353|Drug|Vaway|Drug: Voriconazole. Pharmacokinetic study under fasting conditions
15787665|NCT04551521|Drug|Ipatasertib|400 mg once daily, combination with atezolizumab and taxane according to EMA approved indication only
15787666|NCT04551521|Drug|Atezolizumab|840 mg every 2 weeks
15787544|NCT04552340|Other|Patient with SAR-CoV-2 infection|Study population The study cohort will be enrolled among patients referred to our the Humanitas Research Hospital, the Hospital Cliniche Gavazzeni (Bergamo) hospitals for SARS-CoV-2 screening who will/will not be hospitalized in wards dedicated to COVID-19 patients or admitted to intensive care unit.
15787545|NCT04552327|Device|Solcera|Twice daily application for a duration of 4 weeks followed by another 4 weeks without treatment (up to 2 potential repetitions of this 8-week cycle)
15787546|NCT04552327|Device|Placebo|Twice daily application for a duration of 4 weeks followed by another 4 weeks without treatment (up to 2 potential repetitions of this 8-week cycle)
15787547|NCT04552327|Drug|Solaraze|Twice daily application for a duration of 60 days
15787548|NCT04552301|Behavioral|Cognitive Processing Therapy|Integrated CPT. CPT is based on a social cognitive theory of PTSD that focuses on how the traumatic event is construed and coped with by a person who is trying to regain a sense of mastery and control in his or her life. The asthma components that will be integrated into the intervention include psychoeducation about asthma, barriers to asthma self-care, asthma medication education, inhaler technique, and asthma self-management behaviors.
15787549|NCT04552301|Behavioral|Psychotherapy|The Study Interventionist will conduct generalized supportive psychotherapy with the participants to provide emotional support for both PTSD and general education for asthma.
15787550|NCT04552301|Behavioral|Targeted Asthma Education|The manualized 10-session program of asthma self-management
15787551|NCT04552301|Behavioral|General Asthma Education|A 10-session program of similar time
15787553|NCT04552275|Diagnostic Test|Proteomics Analysis|Determine a panel of circulating proteins that discriminates between patients with and without Hypo-Attenuated Leaflet Thickening (HALT)
15787554|NCT04552262|Drug|BAY2327949|Single dose of 90 mg BAY2327949
15787555|NCT04552262|Drug|Placebo|Single dose of placebo to BAY 2327949
15787556|NCT04552236|Device|Ultrasound ELastography|"A standardized liver Elastography is critical to obtain reliable and accurate results . The patient is imaged in supine or slight 30 degrees left lateral decubitus position, with the right arm elevated above the head to open the intercostal spaces and improve the acoustic window to the liver . it is recommended to sample measurements in the right lobe , which has shown the most reliable results. Transducer pressure on the skin should be similar to regular anatomical B-mode imaging.
~When using SWE techniques, the acoustic radiation force push pulse should be applied perpendicular to the liver capsule, with measurements obtained 4-5 cm deep to the skin and within a minimum 1-2 cm of liver parenchyma to limit refraction of the pulse. The operator should verify that these areas are free of vascular and biliary structures and rib shadows."
15787557|NCT04552223|Drug|Nivolumab|Nivolumab 480mg administered intravenously on Day 1 of each 4 week cycle.
15787558|NCT04552223|Drug|Relatlimab|Relatlimab 160 mg administered intravenously on Day 1 of each 4 week cycle.
15787559|NCT04552210|Diagnostic Test|blood sample|Whole blood was collected on EDTA (1mg/ml) to prevent clotting and DNA degradation.
15787560|NCT04552197|Drug|JNJ-64251330|JNJ-64251330 tablet will be administered orally.
15787561|NCT04552197|Drug|Tofacitinib|Tofacitinib tablets will be administered orally.
15787562|NCT04552184|Other|GPOEM|gastric per oral endoscopic pyloromyotomy
15787563|NCT04552184|Other|SHAM Procedure|intrapyloric injection of saline solution
15787564|NCT04552171|Behavioral|Access to Game Plan app and 24-hour helpline|Game Plan is a web-based application that helps users reflect on their risk for HIV and level of alcohol use, and if interested, make a plan for reducing their sexual risk or drinking.
15787565|NCT04552158|Dietary Supplement|Mediterranean diet|The Mediterranean diet (MedDiet) is a nutritional model inspired by the traditional dietary pattern of some of the countries of the Mediterranean basin. Mediterranean dietary pattern (MDP) gather the following characteristics: abundant consumption of olive oil and high consumption of fruits, vegetables, cereals (preferably as whole grain), legumes, nuts and seeds. The MDP also includes moderate consumption of fish and shellfish, white meat, eggs, and fermented dairy products (cheese and yogurt), as well as relatively small amounts of red meat, processed meats, and foods rich in sugars. Frequent but moderate intake of wine, especially red wine with meals is also recommended
15787566|NCT04552145|Procedure|surgery|standard decompression surgery
15787567|NCT04552145|Behavioral|Physiotherapy|3 month physical therapy treatment including home activity based on a well defined program and 4 to 6 visits at physical therapy intervention center.
15787568|NCT04552132|Device|Multisonic vs Sonic activation of irrigants|Energy is input into the intracanal irrigants for activation in the hopes of increasing irrigant efficacy.
15787569|NCT04552119|Device|HEALICOIL Knotless PEEK|HEALICOIL Knotless PEEK Self-Tapping HEALICOIL Knotless Non-Self Tapping
15787570|NCT04552119|Device|HEALICOIL Knotless REGENESORB|HEALICOIL Knotless REGENESORB Self -Tapping HEALICOIL Knotless REGENSORB Non-Self Tapping
15787571|NCT04552106|Dietary Supplement|3 caps x3/day|3 capsules 3 times daily for 28 days
15787572|NCT04552106|Dietary Supplement|3 caps x2/day|3 capsules 2 times daily for 28 days
15787573|NCT04552106|Dietary Supplement|2 caps x3/day|2 capsules 3 times daily for 28 days
15787574|NCT04552106|Dietary Supplement|2 caps x2/day|2 capsules 2 times daily for 28 days
15787575|NCT04552106|Dietary Supplement|3 caps x1/day|3 capsules 1 times daily for 28 days
15787576|NCT04552093|Drug|Floxuridine|Administration of intra-arterial floxuridine via the HAIP (HAIP chemotherapy) to the liver with concomitant Dutch standard of care systemic FOLFOX (5-FU, leucovorin and oxaliplatin) or FOLFIRI (5-FU, leucovorin and irinotecan).
15787577|NCT04552093|Device|Tricumed IP2000V infusion pump|Surgical implantation of hepatic artery infusion pump (HAIP) followed by administration of the combined chemotherapy (HAIP and systemic).
15787578|NCT04552080|Drug|Amoxicillin|Preoperatively antibiotics of 2 g amoxicillin 1 hour prior to standard implant placement and sinus floor Elevation will be administered. An additional single dose of 500 mg of amoxicillin will be administered 8 hours after surgery and 500 mg thrice daily (8 hourly) on days 1 to 3 following implant placement and sinus floor elevation.
15787667|NCT04551521|Drug|Atezolizumab|1,200 mg every 3 weeks
15788798|NCT04542434|Drug|Niclosamide Oral Tablet|Niclosamide tablets 400 mg 3 times daily for 14 days
15787579|NCT04552080|Other|Placebo|Preoperatively a placebo of 2 g will be administered. An additional single dose of 500 mg of placebo will be administered 8 hours after surgery and 500 mg thrice daily (8 hourly) on days 1 to 3 following implant placement and sinus floor elevation.
15787580|NCT04552067|Drug|Lovenox|patients given curative dose of Lovenox
15787581|NCT04552067|Drug|Enoxaparin|patients given curative dose of Enoxa
15787582|NCT04552054|Device|Mixed Reality+ 3D printing guided localization|Researchers project a three-dimensional reconstructed image of the patient's chest through MR glasses, then overlay the virtual chest with the actual chest. Finally, researchers put the three-dimensional printing navigational template on the surface of the body to guide for percutaneous lung puncture localization.
15787583|NCT04552054|Device|Computerized Tomography guided localization|CT-guided percutaneous lung puncture staining marker localization.
15787584|NCT04552041|Drug|Prospecta|Oral administration.
15787585|NCT04552041|Drug|Placebo|Oral administration.
15787586|NCT04552028|Other|Non invasive oxygenation|To determine if the SpO2 / FIO2 ratio has a correlation with PaO2 / FIO2 ratio to identify respiratory compromise in acute pancreatitis.
15787587|NCT04552015|Diagnostic Test|TST vs PPD microneedle test|TST vs First patch: 800 um in length, PPD1 formulation; Second patch: 1,500 um in length, PPD1 formulation; Third patch: 800 um in length, PPD2 formulation; and Fourth patch: 1,500 um in length, PPD2 formulation
15787588|NCT04552002|Dietary Supplement|Synbiotic group|Probiotics and prebiotics
15787589|NCT04551976|Behavioral|Mindfulness|Pay attention to the present moment, on purpose, in a nonjudgemental way.
15787590|NCT04551963|Drug|Zanubrutinib|80 mg capsules administered at a dose and frequency as specified in the treatment arm
15787591|NCT04551963|Drug|Fluconazole|400 mg administered as 2 x 200 mg capsules once daily (QD)
15787592|NCT04551963|Drug|Diltiazem|180 mg capsule administered once daily (QD)
15787593|NCT04551963|Drug|Voriconazole|200 mg capsules administered twice daily (BID)
15787594|NCT04551963|Drug|Clarithromycin|250 mg capsules administered twice daily (BID)
15787595|NCT04551950|Drug|M7824|Participants will receive bintrafusp alfa until confirmed disease progression, death, unacceptable toxicity and study withdrawal maximum of 2 years (at the discretion of the Investigator).
15787596|NCT04551950|Drug|Carboplatin|Carboplatin will be administered intravenously as per standard of care.
15787597|NCT04551950|Drug|Paclitaxel|Paclitaxel will be administered intravenously as per standard of care.
15787598|NCT04551950|Drug|Bevacizumab|Bevacizumab will be administrated as indicated for standard of care.
15787599|NCT04551950|Drug|Cisplatin|Cisplatin will be administered intravenously as per standard of care.
15787600|NCT04551950|Radiation|Radiotherapy|Participants will receive radiotherapy as per standard of care.
15787601|NCT04551937|Other|Lactose Free 1% Milk|8 oz of study beverage daily
15787602|NCT04551937|Other|Lactose Free 1% Milk + 10 g prebiotic|8 oz of study beverage supplemented with 5 grams of fructooligosaccharide and 5 grams of galactooligosaccharide
15787603|NCT04551924|Drug|HR18034|HR18034（Ropivacaine Liposome for Injection） is a sustained-release liposome
15787604|NCT04551924|Drug|Naropin|Local infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. Naropin 150mg [0.5%, 5mg/mL] x 30mL
15787605|NCT04551911|Drug|Rayaldee 30Mcg Extended-Release (ER) Capsule|Rayaldee 30Mcg Extended-Release (ER) Capsule
15787606|NCT04551911|Drug|Placebo|0Mcg Extended-Release (ER) Capsule
15787607|NCT04551898|Drug|BGB-DXP593|Intravenous (IV) infusion administered over 30 to 60 minutes at a dose as specified in the treatment arm
15787608|NCT04551898|Drug|Placebo|Placebo to match BGB-DXP593 administered as specified in the treatment arm
15787609|NCT04551885|Drug|FT516|Experimental Interventional Therapy
15787610|NCT04551885|Drug|Avelumab|Monoclonal antibody
15787611|NCT04551885|Drug|Cyclophosphamide|Lympho-conditioning agent
15787612|NCT04551885|Drug|Fludarabine|Lympho-conditioning agent
15787613|NCT04551885|Drug|IL-2|Biologic response modifier
15787614|NCT04551872|Behavioral|Digital weight loss intervention|Participants with obesity enter into a proven 6 month weight loss program that utilizes health coaching and goal-setting. It is a remote intervention that is delivered entirely over their phones. Participants will also receive a FitBit and electronic scale.
15787615|NCT04551859|Other|Dynamic Pelvic Floor MRI|6 months after surgery, a Dynamic Pelvic Floor MRI is performed
15787616|NCT04551846|Dietary Supplement|Oligomeric enteral feeding|Oligomeric enteral feeding will be administered to the PICU patients
15787617|NCT04551846|Dietary Supplement|Polymeric enteral feeding|Polymeric enteral feeding will be administered to the PICU patients
15787618|NCT04551833|Drug|Levobupivacaine|Tramadol versus Dexamethasone as adjuvant to Levobupvacain
15787619|NCT04551820|Procedure|Regular Hours|The regular hours cohort includes cholecystectomies performed during the day shift at the Institution during Monday through Friday, not inclusive of national holidays.
15787620|NCT04551820|Procedure|After Hours|The after hours cohort includes cholecystectomies performed outside of the day shift at the Institution during Monday through Friday, on the weekend, or during a national holiday.
15787621|NCT04551820|Device|Robotic-assisted Cholecystectomy|With the patient under general anesthesia, several small incisions are made in the abdomen. Ports are placed, the abdomen is insufflated, and the da Vinci Robotic Surgical System (Intuitive) is docked to the patient and used to complete the cholecystectomy according to the surgeon's standard of care.
15787622|NCT04551807|Procedure|Modified natural cycle|This treatment protocol is defined as a modified natural cycle as the participant will be instructed to (1) administer human chorionic gonadotropin (hCG) to assist with timing of the embryo transfer and (2) supplement the luteal phase with a low dose of progesterone.
15787623|NCT04551807|Procedure|Programmed cycle|This protocol is designated as programmed because the endometrial development occurs only in association with administration of estradiol and progesterone. No ovulation occurs due to suppression of follicle development by the estradiol and the timing of the transfer is based on the number of days elapsed following initiation of exogenous progesterone.
15788799|NCT04542434|Drug|Placebo|Matching placebo tablets 3 times daily for 14 days
15787624|NCT04551794|Behavioral|Selfapy with therapeutic guidance|The program consists of 9 modules with many interactional exercises. Themes that are addressed in the online-program are for example self-esteem, coping with relapse, establishing a structure for daily life and attention and breathing exercises as well as depression-specific topics such as negative thoughts management and arranging and maintaining social contacts. In addition, participants were able to talk about personal experiences with a therapeutic guide.
15787625|NCT04551794|Behavioral|Selfapy with additional peer support|The program consists of 9 modules with many interactional exercises. Themes that are addressed in the online-program are for example self-esteem, coping with relapse, establishing a structure for daily life and attention and breathing exercises as well as depression-specific topics such as negative thoughts management and arranging and maintaining social contacts. In addition, participants were able to participate in exchange with peers via an internal closed forum.
15787626|NCT04551781|Drug|20 Mg Prednisone for 14 days|20 Mg Prednisone for 14 days
15787627|NCT04551781|Drug|control|symptomatic ttt
15787628|NCT04551768|Drug|50 mg/mL Virazole|50 mg/mL Virazole aerosolized and administered over 1 hour twice a day for up to 6 days.
15787629|NCT04551768|Drug|100 mg/mL Virazole|100 mg/mL Virazole aerosolized and administered over 30 minutes twice a day for up to 6 days.
15787630|NCT04551755|Drug|Ivermectin and Doxycycline|"Tab Ivermectin (6mg): 12mg first dose then one more dose of 12mgafter 12 hours
~Cap. Doxycycline (100mg): 1+0+1 after meal for 10 days. To be taken with half glass of water and sit up for 20 minutes"
15787631|NCT04551755|Other|Placebo|Placebo (1) 2 tab stat then again 2 tab after 12 hours Placebo (2) will be given as 1+0+1 for 10 days
15787632|NCT04551729|Behavioral|Lifestyle advice for liberal fluid intake|Lifestyle advice for liberal fluid intake for 3 months
15787633|NCT04551703|Drug|Adrenaline saline irrigation|The surgical field is flushed with 20 cc of Adrenaline saline irrigation. This is in contrast to the standard of care, normal saline irrigation.
15787634|NCT04551677|Biological|Fluzone Quadrivalent vaccine, No Preservative (0.5-mL dose), 2020-2021 formulation|"Pharmaceutical form: Suspension for injection in a pre-filled syringe,
~Route of administration: Intramuscular (IM)"
15787635|NCT04551677|Biological|Fluzone High-Dose Quadrivalent vaccine (0.7-mL dose), 2020-2021 formulation|"Pharmaceutical form: Suspension for injection in a pre-filled syringe,
~Route of administration: IM"
15787636|NCT04551664|Drug|Best medical management|All the patients enrolled received standard guideline-directed medical therapy including: monitor vital signs, management of blood pressure, glucose and lipids, antithrombotic (antiplatelet or anticoagulant therapy determined by treating physician) therapy if appropriate.
15787637|NCT04551664|Procedure|Endovascular therapy|In the procedure, the methods including mechanical thrombectomy, aspiration thrombectomy, intra-arterial thrombolysis, angioplasty and stenting can be used according to the local interventionalists' choice. Mechanical thrombectomy (recommended with Solitaire、EMBOTRAP、Trevo or Reco revascularization device) or aspiration thrombectomy (recommended with Penumbra) will be recommended as the primary treatment.
15787638|NCT04551651|Device|ApplTree|App downloaded on the participants phone, a short video tutorial session to explain use, and technical support throughout trial period.
15787639|NCT04551651|Device|Google Calendar|App downloaded on the participants phone, a short video tutorial session to explain use, and technical support throughout trial period.
15787640|NCT04551638|Other|Psychological assessment with the Repertory Grid Technique|The RGT is a constructivist psychological tool to explore the structure and content of personal identity.
15787641|NCT04551625|Device|High Resolution Colonic Manometry and 3D-Transit system.|Not performed as an intervention, the study is observational.
15787642|NCT04551612|Radiation|Multislice computed tomography temporal bone|Patients with cholesteatoma will undergo multislice computed tomography (MSCT) temporal bone images. Then The Tegmen level will be determined and compared with the other normal ear at the same patient
15787643|NCT04551599|Drug|Danicopan|A single dose of danicopan (200 milligrams) will be administered orally.
15787644|NCT04551586|Drug|ACH-0145228: Immediate Release|ACH-0145228 (240 milligrams) will be administered orally on Day 1.
15787645|NCT04551586|Drug|ACH-0145228: Powder-in-capsule|ACH-0145228 (240 milligrams) will be administered orally on Day 1.
15787646|NCT04551573|Drug|Rifapentine daily|In addition to taking Biktarvy for four weeks, participants will also take Rifapentine dosed daily for four weeks (10mg/kg; 600 mg dose)
15787647|NCT04551573|Drug|Rifapentine weekly|In addition to taking Biktarvy for four weeks, participants will also take Rifapentine dosed weekly for another four more weeks (15 mg/kg; 900mg dose)
15787648|NCT04551560|Other|Mental Stress|Patients will undergo a lab mental stress protocol, and a field protocol using ecological momentary assessment (EMA) to test the effects of psychological stress and negative emotion on PAP in HF patients.
15787649|NCT04551547|Biological|Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28|The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research & Development Co., Ltd., with a antigen content of 300SU/0.5ml
15787650|NCT04551547|Biological|Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28|The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research & Development Co., Ltd., with a antigen content of 600SU/0.5ml
15787651|NCT04551547|Other|Two doses of placebo at the schedule of day 0,28|The placebo contains no active ingredient and manufactured by Sinovac Research & Development Co., Ltd.
15787652|NCT04551534|Drug|DNL201|Oral dose(s)
15787653|NCT04551534|Drug|Placebo|Oral dose(s)
15787654|NCT04551521|Drug|Vemurafenib|960 mg twice daily during run-in Phase, followed by 720 mg twice daily
15787655|NCT04551521|Drug|Cobimetinib|60 mg once daily
15787656|NCT04551521|Drug|Atezolizumab|840 mg every 2 weeks
15787657|NCT04551521|Drug|Trastuzumab|8 mg per kilogram of body weight as a loading dose, followed by 6 mg per kilogram every 3 weeks
15787658|NCT04551521|Drug|Pertuzumab|840 mg as a loading dose, followed by 420 mg intravenously every 3 weeks
15787659|NCT04551521|Drug|Alectinib|600 mg twice daily
15787660|NCT04551521|Drug|Ipatasertib|400 mg once daily
15787661|NCT04551521|Drug|Cobimetinib|arm 6: 60 mg once daily
15787662|NCT04551521|Drug|Atezolizumab|1200 mg every 3 weeks
15787663|NCT04551521|Drug|Atezolizumab|1200 mg in the first cycle, followed by 840 mg every 3 weeks
15787671|NCT04551482|Drug|Oxytocin nasal spray|24 IU nasal spray, 4 times per day for 12 weeks
15787672|NCT04551482|Drug|Placebo|24 IU nasal spray, 4 times per day for 12 weeks
15787673|NCT04551469|Behavioral|music|Music intervention for 30 minutes
15787674|NCT04551456|Biological|Intravenous infusion human umbilical Wharton's jelly-derived mesenchymal stem Cell or placebo PBS|Randomised, Double-blind, Placebo-controlled, Intravenous Infusion HumanWharton' Jelly-derived Mesenchymal Stem Cells in Patients With Coronary Artery Disease
15787675|NCT04551443|Biological|Intravenous infusion placebo|Intravenous infusion placebo or WJMSCs in patients with AMI
15787676|NCT04551443|Biological|Intravenous infusion WJMSCs|Intravenous infusion WJMSCs or placebo in patients with AMI
15787677|NCT04551430|Drug|Cabozantinib|Cabozantinib will be supplied by Exelixis.
15787678|NCT04551430|Drug|Nivolumab|Nivolumab will be provided free of charge (as investigational supply) by Bristol-Myers Squibb.
15787679|NCT04551430|Drug|Ipilimumab|Ipilimumab will be provided free of charge (as investigational supply) by Bristol-Myers Squibb.
15787680|NCT04551417|Procedure|Free graft urethroplasty|Free graft urethroplasty will be performed either with ventral or dorsal onlay of the graft.
15787681|NCT04551404|Other|transcranial Random Noise Stimulation (tRNS) with acoustic stimulation (AS)|The study intervention consists of a bilateral tRNS application over temporal regions, parallel to the application of AS with WN 15 dB above the individual MML in one study arm. TRNS will be applied using two electrodes (35 qcm, 0,9% saline -soaked). Stimulus intensity will be below individual sensation threshold, but max. 2 mA. AS will never surpass 85 dB SPL at the ears.
15787682|NCT04551404|Other|transcranial Random Noise Stimulation (tRNS) without acoustic stimulation (AS)|The study intervention consists of a bilateral tRNS application over temporal regions
15787683|NCT04551391|Other|Blood and urine sampling|Retinal OCT is a novel, non-invasive method for cross-sectionally imaging the eye's retina and choroid
15787684|NCT04551378|Other|Quality-of-Life Assessment|Ancillary studies
15787685|NCT04551378|Other|Survey Administration|Complete survey
15787686|NCT04551365|Behavioral|Lifestyle changes|Interdisciplinary rehabilitation programmes 5 days per week, for 4-6 weeks. The aim of the rehabilitation programme is to improve lifestyle through improved planning of activities of daily life, improved planning of food intake, increased physical activity, and weight loss. The focus is on physical and mental well-being and reinforcing participation in social activities. Patients are encouraged to carry on with their lifestyle changes after dismission from the program. Total duration 14 weeks
15787687|NCT04551365|Dietary Supplement|Chitosan|Daily intake of chitosan supplement. Daily dose: 4 capsules(1,5 g chitosan) twice at main meals; total 3 g Duration: 12 weeks
15787688|NCT04551365|Other|Placebo|Daily intake of placebo (Microcrystalline cellulose (MCC), and native maize food starch (FS)) Daily dose: 4 capsules(0.75 g MCC + 0.75 g FS) twice at main meals; total 3 g Duration: 12 weeks
15787689|NCT04551352|Drug|RO7293583|RO7293583 will be administered at a dose and per schedule as specified for the respective cohort.
15787690|NCT04551352|Drug|Tocilizumab|Tocilizumab will be administered as required for the management of severe cytokine release syndrome (CRS).
15787691|NCT04551352|Drug|Obinutuzumab|If implemented, it will be given either on D-7 or D-7 and D-6.
15787692|NCT04551352|Drug|Adalimumab|If implemented, it will be given as a single dose approximately 6 days prior to the first dose of RO7293583.
15787693|NCT04551339|Dietary Supplement|PreserVision AREDS formulation soft gels or tablets|Two tabs taken daily for three months
15787694|NCT04551339|Dietary Supplement|Multivitamin with 11mg of zinc|One tab taken daily for three months
15787695|NCT04551326|Other|manual hamstring stretching|Participants' lower limb will be positioned in maximal hip flexion and gradually moved to maximal knee extension by physical therapist. The procedure will take one minute for each lower limb.
15787699|NCT04551287|Diagnostic Test|Cervical Cancer Artificial Intelligence Screening System|Cervical Cancer Artificial Intelligence Screening System (CAISS) was trained and validated for cervical cytology grade diagnosis through diverse cervical cytological whole slide images (WSIs) from different hospitals.
15787700|NCT04551274|Behavioral|Music Therapy|Music Therapy interventions involve the use of live music (performed or created by the therapist and/or patient), and a process that includes patient-specific assessment, treatment, and evaluation
15787701|NCT04551261|Drug|GLS4|It is a new dihydropyrimidine antiviral drug that interferes the assembly of HBV core granule.
15787702|NCT04551261|Drug|RTV|"It is HIV protease inhibitors indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection;
~It is a CYP3A inhibitor combined with other drug to increase the exposure in human."
15787703|NCT04551261|Drug|TAF|It is a hepatitis B virus (HBV) nucleoside analog reverse transcriptase inhibitor and is indicated for the treatment of chronic hepatitis B virus infection in adults with compensated liver disease.
15787704|NCT04551248|Biological|10 or 13-valent pneumococcal conjugate vaccine|a four-dose series that is indicated for use at 2, 4, 6, and 12 to 15 months of age.
15787705|NCT04551248|Biological|23-valent pneumococcal polysaccharide vaccine|Single 0.5-mL dose administered intramuscularly or subcutaneously only.
15787706|NCT04551248|Biological|Influenza vaccine|One dose of trivalent influenza vaccine in flu seasons.
15787707|NCT04551235|Other|there are not any interventions in this study|there are not any interventions in this study
15787749|NCT04550923|Combination Product|Z-Brace interbody fusion device|Use non-rigid (Titanium Alloy, Z-Brace, Baui Biotech) interbody fusion device in Anterior Cervical Discectomy and Fusion (ACDF) surgery
15787710|NCT04551209|Procedure|Maintaining apical patency|In apical patency group, a size 10 K file will be passed beyond the apical foramen between each instrument change to maintain apical patency while in Non apical patency group, K file will be carried up to the working length only. A final peri-apical radiograph will be taken in the group A with the 10 K patency file 01mm beyond the apical foramen to confirm patency.
15787711|NCT04551196|Drug|Alternating Acetaminophen and Ibuprofen|Subjects will alternate their post-operative acetaminophen and ibuprofen every 3 hours.
15787712|NCT04551196|Drug|Combined Acetaminophen and Ibuprofen|Subjects will take their post-operative acetaminophen and ibuprofen together every 6 hours.
15787713|NCT04551183|Other|Surgeons CT scan analysis|Surgeons extract diameter by hand (Gold Standard method) then realised a semi-manual segmentation of the images to extract volumes and diameters of the aorta (espacially AAA)
15787714|NCT04551183|Device|PRAEVAorta CT scan analysis|CT scans are analysed by the software under investigation : PRAEVAorta. It will extract volumes and diameters of the aorta (AAA espacially)
15787715|NCT04551170|Drug|Theophylline|oral theophylline
15787716|NCT04551170|Drug|Placebo|Placebo capsule or elixir
15787717|NCT04551157|Other|Video Viewing|Two patient information videos containing practical advice from staff about the recovery process, images of the wound throughout the healing process and ways to cope with the range of emotional responses that patients report following an open fracture.
15787718|NCT04551144|Drug|testosterone cypionate|intramuscular injection every 2 weeks. Dose will be titrated based on blood levels
15787719|NCT04551144|Drug|Estradiol Valerate|intramuscular injection every week. Dose will be titrated based on blood levels
15787723|NCT04551118|Device|Transcranial alternating current stimulation (tACS) -active|Transcranial alternating current stimulation (tACS) is a non-invasive neuromodulation technique of the brain with an AC micro-electrical stimulator, two rubber electrodes in saline-soaked sponges, and a control software to set the output of the stimulation type. Participants receive 20 min sessions of 1.5 mA alternating current delivered over the dorsolateral prefrontal cortex, for 7 consecutive days.
15787724|NCT04551118|Device|Transcranial direct current stimulation (tDCS)-active|Transcranial direct current stimulation (tDCS) is a non- invasive neuromodulation technique of the brain with a DC micro-electrical stimulator, two rubber electrodes in saline-soaked sponges, and a control software to set the output of the stimulation type. Participants receive 20 min sessions of 1.5 mA direct current delivered over the dorsolateral prefrontal cortex, for 7 consecutive days.
15787725|NCT04551118|Device|Transcranial electrical stimulation (TES)-sham|Transcranial electrical stimulation (TES) is a non-invasive neuromodulation technique of the brain with micro-electrical stimulator, two rubber electrodes in saline-soaked sponges, and a control software to set the output of the stimulation type. Participants receive sham stimulation over the dorsolateral prefrontal cortex, with current turned off after 30 second. The session last 20 min for 7 consecutive days.
15787726|NCT04551105|Diagnostic Test|Reader Group X|"Each rater in Reader Group X will interpret the dataset A cases in different random order without BR-USCAD DS and interpret the dataset B cases in different random order with BR-USCAD DS."
15787727|NCT04551105|Diagnostic Test|Reader Group Y|"Each rater in Reader Group Y will interpret the dataset A cases in different random order with BR-USCAD DS and interpret the dataset B cases in different random order without BR-USCAD DS."
15787728|NCT04551092|Device|NEVR|a non-invasive, non-pharmacological alternative to treat pain by combining an innovative electroencephalography (EEG)-based Neurofeedback solution in an immersive virtual reality (VR) environment.
15787729|NCT04551079|Drug|TAK-994|TAK-994 tablets.
15787730|NCT04551079|Drug|Placebo|TAK-994 placebo-matching tablets.
15787737|NCT04551040|Drug|Terazosin|Terazosin 1 mg oral capsule
15787738|NCT04551027|Behavioral|compensatory cognitive treatment|a brief group compensatory cognitive intervention including 12 meetings of 1 hour in a group of five and focuses on these cognitive domains: prospective memory, vigilance and attention, memory and learning and executive functions
15787739|NCT04551014|Device|Use of EverLift|Use of EverLift for submucosal injection prior to polypectomy
15787740|NCT04551014|Device|Without use of EverLift|Without use of EverLift for submucosal injection prior to polypectomy
15787741|NCT04551001|Procedure|Cold forcep polypectomy|Removal of appropriate polyps using cold forceps until no polyp visible under white light. Two additional biopsies performed at margins of polypectomy site.
15787742|NCT04551001|Procedure|Cold snare polypectomy|Removal of appropriate polyps using cold snare until no polyp visible under white light. Two additional biopsies performed at margins of polypectomy site.
15787744|NCT04550975|Other|Advanced Cognitive Stimulation Therapy|An adapted version of Cognitive Stimulation Therapy for people with moderate to severe dementia.
15787745|NCT04550962|Drug|Dupilumab SAR231893|"Pharmaceutical form:solution Route of administration: subcutaneous
~Dose regimen:"
15787746|NCT04550949|Drug|QL1206|The active ingredient of QL1206 is a recombinant human anti-RANKL monoclonal antibody ,subcutaneous injection of 120 mg (1.7ml)every 4 weeks for a maximum of 13 consecutive doses throughout the trial.
15787747|NCT04550949|Drug|Xgeva|The active ingredient of Xgeva® is denosumab,subcutaneous injection of 120 mg (1.7ml)every 4 weeks for a maximum of 13 consecutive doses throughout the trial.
15787748|NCT04550936|Drug|Isavuconazole|antifungal agent
15787933|NCT04549467|Drug|Lamivudine 300 MG|Experimental arm
15787750|NCT04550923|Combination Product|PEEK interbody fusion device|Use rigid (PEEK) interbody fusion device in Anterior Cervical Discectomy and Fusion (ACDF) surgery
15787751|NCT04550910|Radiation|Hypofractionation Schedules for Breast Cancer patients after mastecomy|Two Radiotherapy HypoFractionation Schedules will be applied, after randomization, for female breast cancer patients after mastectomy.
15787752|NCT04550897|Drug|BM7PE|BM7PE immunotoxin is supplied as a liquid solution and is diluted in 0.9% saline to a total volume of 250 ml.
15787753|NCT04550884|Diagnostic Test|neuromascular ultrasound|neuromascular ultrasound of foot and ankle
15787754|NCT04550858|Drug|Rebamipide|rebamipide use for ttt of h.pylori infection
15787755|NCT04550845|Behavioral|Nurse-navigated coaching|The nurse-navigated coaching intervention will be based on the Patient Navigation Research Program (PNRP), sponsored by the National Cancer Institute (NCI) Center to Reduce Cancer Health Disparities. The goal of patient navigation is to facilitate timely access to quality cancer care that meets cultural needs and standards of care for all patients. Examples of navigation services includes identifying and scheduling appointments with culturally sensitive providers, addressing health literacy, coordinating care among providers, ensuring coordination of services among medical personnel, and providing other services to overcome access barriers encountered during the cancer care process.
15787756|NCT04550832|Drug|Delpazolid|Delpazolid is not licensed yet. Current experience in humans upto Phase IIA. Dose according to randomization to dosing arms 2-5.
15787757|NCT04550832|Drug|Bedaquiline, Delamanid, Moxifloxacin|These three licensed drugs form the backbone of a new regimen to which delpazolid is added in arms 2-5.
15787758|NCT04550819|Procedure|intraintestinal extended biliary stents|The test group will be placed intraintestinal extended biliary stents in intrahepatic bile duct in ERCP
15787759|NCT04550819|Procedure|ordinary plastic biliary stents|The test group will be placed ordinary plastic biliary stents in intrahepatic bile duct in ERCP
15787760|NCT04550793|Drug|Botulinum toxin injection|Botulinum toxin injection at affected brachialis and/or biceps brachials.
15787762|NCT04550741|Other|telerehabilitation|After obtaining consent, the volunteers will be included in the study at the start of the 4th week and randomized into two arms: Experimental and Control group
15787763|NCT04550728|Combination Product|Ankle robot training group|Patients will be seated with the paretic foot strapped to the footplate the knee at full extension. The operator will set up and measure (using the robot) ankle passive DF and PF ROM limits. The robot training will include passive stretching, robot interactive game-based training, and cool-down stretching.
15787764|NCT04550728|Combination Product|Ankle robot training and functional electrical stimulation(FES) group|Patients will use the ankle robot device as the ankle training group. Also, water-based FES electrodes positioned inside a soft garment will be secured over the DF and PF muscles by wrapping the garment around the leg just below the knee joint. Stimulation intensity will be increased to maximal tolerance of each participant. Electrically induced contraction timing will be triggered by the ankle robot in synchrony with the ankle dorsi and plantar flexion movements.
15787765|NCT04550715|Behavioral|Brief intervention (BI)|A remote brief intervention delivered by health coaches that uses Motivational Interviewing to address opioid misuse and risk factors. Remote health coaches use a web-based clinician support guide to maintain fidelity, while tailoring the session to unique participant factors.
15787766|NCT04550715|Behavioral|Portal|Remote health coaches will push tailored messages to participants over a 4-week period. The messages will use Motivational Interviewing strategies. The messages are designed to elicit a response from the participant. Health coaches will also respond to participant replies consistent with Motivational Interviewing over a course of 4 weeks.
15787767|NCT04550715|Behavioral|Enhanced Usual Care (EUC)|The brochure covers educational topics like opioid storage and disposal and overdose prevention, as well as resources such as naloxone, suicide hotlines, mental health, and substance use treatment. It will be available online and in print.
15787768|NCT04550702|Drug|Mirabegron 25mg|Mirabegron 25 mg per day
15787769|NCT04550689|Device|Bone graft|Bone grafts produced by Straumann LLC
15787770|NCT04550676|Behavioral|HIIT (intervention)|Following a 5-minute warm-up, high and moderate-intensity exercise bouts will alternate: a five bouts of 4-minute high-intensity exercise (90% VO2peak) will alternate with four 3-minute bouts of moderate-intensity exercise (50% VO2peak) by week 8. This is followed by a 5-minute cool-down. The total exercise time will be 42 minutes. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 3 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
15787771|NCT04550676|Behavioral|CME (active control)|Following a 4-minute warm-up, the participant will walk/jog for up to 42 continuous minutes at 60% VO2peak. This is followed by a 4-minute cool-down. The total exercise time is 50 minutes. For resistance exercise, the initial goal will be to complete 3 sets of 8-10 repetitions of 3 exercises at low intensity (50% 1-RM) and then progress to moderate intensity (70-80% 1-RM). Exercise intensity will increase every 4 weeks or when participants can complete more than 8 repetitions with proper form at the prescribed weight.
15787772|NCT04550663|Drug|KD-025 CAR-T cells|Autologous genetically modified anti-NKG2DLs CAR transduced T cells
15787773|NCT04550650|Other|Training groupe|Using virtual training
15787774|NCT04550650|Other|PNF|PNF technique was used
15787775|NCT04550650|Other|Spinning grp|They only worked with spinning bikes.
15787776|NCT04550650|Other|Balance|Balance development was done
15787777|NCT04550637|Drug|Oral apixaban|apixaban (5 mg bid) is given until 12 weeks after surgery
15787778|NCT04550624|Drug|Pembrolizumab Injection [Keytruda]|200mg IV on day 1 of each cycle
15787779|NCT04550624|Drug|Lenvatinib Mesylate|20mg PO daily days 1-21 of each cycle
15787780|NCT04550611|Other|Mini-pool Intravenous Immunoglobulin (MP-IVIG)|The process of MP-IVIG preparation will involve the use of caprylic acid for purification and virus inactivation of Igs from mini-pools of 20 plasma donations collected in our CBTS in AUH. The equipment used for the process comprised disposable blood bags, hemodialyzers, and purification and microbial filters.
15787781|NCT04550611|Other|plasma exchange|plasma exchange (plasmapheresis ) in a regimen of removing of 1.3 plasma volumes in each cycle for total of five cycle for five consecutive days within four weeks of onset of symptoms.
15787782|NCT04550598|Device|HD-tCES|The high definition transcranial electrical stimulation was applied using a 1*4 ring electrode configuration. The electrode will be applied at the left M1 or contralateral to pain side. The anodal electrode was placed on the C3/C4, and the remaining 4 cathodal electrodes were placed in a radius of approximately 7.5 cm from anode (Cz, F3, T7, and P3 on the left hemisphere or Cz, F4, T8, and P4 on the right hemisphere). HD-tCES will be applied for 20 minutes at an intensity of 1.0 mA direct current stimulation and a specific-added waveform each time, 5 times a week, lasting for 2 weeks.
15787783|NCT04550598|Device|Sham HD-tCES|The high definition transcranial electrical stimulation was applied using a 1*4 ring electrode configuration. The electrode will be applied at the left M1 or contralateral to pain side. The anodal electrode was placed on the C3/C4, and the remaining 4 cathodal electrodes were placed in a radius of approximately 7.5 cm from anode (Cz, F3, T7, and P3 on the left hemisphere or Cz, F4, T8, and P4 on the right hemisphere). Sham HD-tCES will consist of a 5-second ramp up to 1.0 mA direct current stimulation and a specific-added waveform followed immediately by a 5-second ramp down, no current in the middle 19 minutes 40 seconds, and a ramp-up and ramp-down period during the last 10 seconds.
15787784|NCT04550585|Other|Education: Session 1 - Basics of type 1 management|"In a group education session, a diabetes educator provides educational session 1 - Basics of type 1 management.
~Accompanying educational guide:
~How Can I Manage My Type 1 Diabetes Better?"
15787785|NCT04550585|Other|Session 2 - Carbohydrate counting|"In a group education session, a diabetes educator provides educational session 2 - Carbohydrate counting
~Accompanying educational guide:
~How Can I Manage My Type 1 Diabetes Better?"
15787786|NCT04550585|Other|Education: Session 3 - Insulin self- adjustment|"In a group education session, a diabetes educator provides educational session 3 - Insulin self- adjustment
~Accompanying educational guide:
~How Can I Manage My Type 1 Diabetes Better?"
15787787|NCT04550585|Other|Education: Session 4 - Sick day rules and physical activity dose adjustments|"In a group education session, a diabetes educator provides educational session 4 - Sick day rules and physical activity dose adjustments
~Accompanying educational guide:
~How Can I Manage My Type 1 Diabetes Better?"
15787788|NCT04550585|Other|Education: Session 5 - Starting the insulin pen (for pen users) or pump (for pump users)|"In a group education session, a diabetes educator provides educational session 5 - Starting the insulin pen (for pen users) or pump (for pump users)
~Accompanying educational guide:
~Is the Insulin Pump Right for Me? How Do I Use an Insulin Pump? Is the Insulin Pen Right for Me?"
15787789|NCT04550585|Other|Education: Session 6 - Trouble shooting the pump (for pump users)|"In a group education session, a diabetes educator provides educational session 6 - Trouble shooting the pump (for pump users)
~Accompanying educational guide:
~Is the Insulin Pump Right for Me? How Do I Use an Insulin Pump?"
15787790|NCT04550559|Procedure|Endoscopic ureterolitotripsy|Endoscopic ureterolithotripsy
15787791|NCT04550546|Drug|Nystatin|600,000 U/mL of nystatin in a rinse suspension
15787792|NCT04550533|Other|Therapeutic Adherence|To measure adherence to treatment in oncohematological patients in treatment with oral anti-cancer drugs
15787793|NCT04550520|Diagnostic Test|Glucagon|Glucagon with the empirical formula of C153H225N43O49S, and a molecular weight of 3483 g/mol, is a single-chain polypeptide containing 29 amino acid residues. Glucagon is provided in a single dose vial as powder. One container contains 1 mg of glucagon which results in a concentration of 1 mg/ml after dissolution in a volume of 1 ml (Glucagen NovoNordisk (Hypokit)). The currently used standard dose regimen is 1 mg of glucagon in adults. The solution for subcutaneous injection will be prepared by the study personnel according to the attached package leaflet.
15787794|NCT04550520|Diagnostic Test|Placebo|As placebo 1 ml sodium chloride (NaCl) 0.9% to inject subcutaneous is used. It has the same optical appearance as glucagon.
15787795|NCT04550507|Behavioral|Mindful sensory awareness intervention|The mindfulness sensory awareness exercise will be a brief (3-5 minutes), guided meditation focusing on sensory and interoceptive awareness developed by Co-I Price, modified slightly to meet the needs of this age group and targeted for attention to indicators of fatigue or a sense of overstimulation. Youth will be asked to use the exercise after ending media use but before trying to sleep. The meditation component will be delivered via an audio-guided MP3, along with illustrated instructions in both handout and video, and a guided workbook that coaches youth over the 8-week intervention period to practice their skills, reflect on their experiences, and maintain adherence.
15787796|NCT04550507|Behavioral|Mindful sensory awareness + mindful body awareness check-ins intervention|During the intervention period for Group B: Mindful Sensory & Body Awareness(the second 8 weeks), they will receive the same mindful sensory awareness intervention, and also learn the mindful body awareness check-ins to guide media use choices strategy (referred to here as the check-ins component). We will coach youth to pause briefly every 30 minutes during media use to discern if they detect physical, cognitive, or emotional signs of escalated state arousal, and to make an intentional and real-time choice about possible changes in media use content or duration to help decrease state arousal levels before bed.
15787797|NCT04550494|Procedure|Biopsy|Undergo biopsy
15787798|NCT04550494|Drug|Talazoparib|Given PO
15787799|NCT04550481|Drug|Lisinopril|Given PO
15787800|NCT04550481|Other|Questionnaire Administration|Ancillary studies
15787801|NCT04550468|Other|Low-Carb High-Fat breakfast|Participants will receive 8 low-carb high-fat breakfast meal recipes to follow daily during 3 months.
15787802|NCT04550468|Other|"Low fat standard care control breakfast"|Participants will receive 8 low-fat breakfast meal recipes to follow daily during 3 months.
15787803|NCT04550455|Drug|Cladribine Tablets|Cladribine tablets will be administered according the current package insert guidelines
15787804|NCT04550442|Drug|Azacitidine|Given IV or SC
15787805|NCT04550442|Drug|Venetoclax|Given PO
15787806|NCT04550429|Device|MyoSure Hysteroscopic Morcellator Device|This device is normally used for this procedure, but I included it as intervention because we will lower the pressure for one arm of the study (treatment) and keep the pressure in the other arm (control) as the standard of care.
15787807|NCT04550416|Other|ProMark Information and Test Results|Participants in the intervention arm will receive information (both print and webinar format) about ProMark in between Round 1 and Round 2 data collection, as well as appropriate ProMark test results for each of the vignette-based simulated patients that they care for in the second round of data collection.
15787808|NCT04550390|Diagnostic Test|Saliva collection|2 saliva samples are self-collected by participants
15787809|NCT04550377|Drug|Cannabidiol|The drug product to be used in this study is an oral formulation of CBD
15787810|NCT04550377|Drug|Placebo|non-active medication
15787811|NCT04550351|Biological|Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cell) low-dose group|Intramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
15787812|NCT04550351|Biological|Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) high-dose group|Intramuscular injection of deltoid muscle of upper armof 50μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
15787813|NCT04550351|Biological|Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) placebo group|Intramuscular injection of deltoid muscle of upper armof 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
15787814|NCT04550338|Drug|Tranexamic acid|Oral administration of blinded medications
15787815|NCT04550338|Drug|Placebo|Oral administration of blinded medications
15787816|NCT04550325|Biological|Kamada Anti-SARS-CoV-2|Anti-SARS-CoV-2 is a preparation of immune gamma globulin manufactured from convalescent plasma of COVID-19 recovered patients, using Kamada's proprietary purification methods
15787817|NCT04550299|Other|Surgical technique combined with a specific choice of the material for the ligament reconstruction|The surgical procedure is done as standard of care. The intervention is to randomize the participant into the study arms, which none of those has been proved yet to be a superior choice
15787818|NCT04550286|Behavioral|Smartphone Use Reduction in Academic Context|"Students will be given general advice on how to organize their exam preparation environment and behavior to improve their overall learning performance (e.g., organization of materials for exam preparation, pauses during exam preparation). This refers to the behavior change techniques (BCT 4.1, instructions on how to perform the behavior; Michie et al.; 2013).
~In the next step, participants in the intervention group complete planning sheets. Each student has to develop up to three action plans (BCT 1.4) including when, where, and for how long the smartphone will be put away during the daily exam preparation period (cf. Radtke et al., 2018). In addition, each participant should try to anticipate possible barriers to engaging in the planned behavior and plan what he or she could do to overcome these possible barriers (i.e., coping planning; BCT 1.2; Michie et al., 2013)."
15787819|NCT04550286|Behavioral|Control|Students will be given general advice on how to organize their exam preparation environment and behavior to improve their overall learning performance (e.g., organization of materials for exam preparation, pauses during exam preparation).
15787820|NCT04550273|Behavioral|aerobic treadmill exercise|The study group (n=20) received three sessions of aerobic exercise per week for 3 months. Every session was done on an electronic treadmill with no inclination started with 5 minutes warm-up then 30 minutes of moderate-intensity aerobic training with 60-75% of target heart rate then followed or ended by 5 minutes cool down.
15787826|NCT04550234|Drug|Verinurad prolonged release HPMC capsule|Randomized subjects will receive oral dose of verinurad HPMC capsule.
15787827|NCT04550234|Drug|Allopurinol Tablet|Randomized subjects will receive oral dose of allopurinol tablet.
15787828|NCT04550234|Drug|Verinurad/Allopurinol FDC Capsule|Randomized subjects will receive oral dose of Verinurad/Allopurinol FDC capsule.
15787829|NCT04550234|Drug|Verinurad prolonged release gelatin Capsule|Randomized subjects will receive oral dose of Verinurad gelatin capsule.
15787830|NCT04550221|Behavioral|Shauriana|The components of this intervention are: four weekly in-person sessions with a trained peer intervention specialist; optional additional in-person or by phone check-ins after the in-person sessions are delivered; and optional monthly group sessions. The four in-person health education and coaching sessions will be delivered once per week, by trained peer facilitators who identify as GBMSM. These sessions will focus on the following topics: sexual health basics (understanding how HIV and STIs are transmitted, prevented, and diagnosed/treated), relationships (types of relationships we have, characteristics of healthy relationships, communication skills), stress and coping (understanding mental health challenges, adaptive and maladaptive coping strategies), and healthy sexuality and empowerment (understanding sexual orientation and gender identity, challenging stereotypes about GBMSM, making sexual choices).
15787831|NCT04550208|Other|3D analysis of different landing tasks|General as well as more sport-specific landing tasks are investigated with 3D analysis by using an opto-electronic system
15787832|NCT04550195|Drug|BMS-986337|Specified Dose on Specified Days
15787833|NCT04550195|Other|BMS-986337 Placebo|Specified Dose on Specified Days
15787834|NCT04550195|Biological|Famotidine|Specified Dose on Specified Days
15787835|NCT04550182|Procedure|Positioning schedule|"The Braden scale will be collected every morning. Patients' care will be friction and repositioning applied at a frequency defined by the Braden scale:
~6 ≥ Braden ≤ 8: alternate positioning every 2 hours 9 ≥Braden ≤ 13: alternate positioning every 4 hours 14 ≥ Braden ≤ 17: No alternative of the positioning required, but a friction and an evaluation of the cutaneous state every 6 hours.
~18 ≥Braden ≤ 23: No alternative of the positioning required, but a friction and an evaluation of the cutaneous state every 12 hours.
~Positioning will alternate semi-lateral decubitus at 30, semi-Fowler 30° -30°, half-sitting position 45° with elevation of the lower limbs.
~A medical prescription as part of the daily reassessed care will ensure the absence of absolute contraindication to the mobilization or contraindication to certain positions.Friction will be performed during repositioning."
15787836|NCT04550169|Other|Intensive Care Coordination|"Intensive care coordination will include:
~Discharge instructions and contacts for following up on care and treatment
~Referral information
~Appointment scheduling
~Medication instructions
~Intensive care coordination by a social worker, case manager, nurse, or care coordinator to connect Medical Assistance (MA) recipient to a primary care provider or to a managed care organization
~Information about other health and social resources, such as transportation and housing
~Sharing of information (discharge instructions, medication information, and care plan information) with managed care organization in which patients are enrolled, if applicable"
15787934|NCT04549467|Drug|Emtricitabine / Tenofovir Disoproxil Pill|Active Comparator
15787837|NCT04550156|Procedure|Colorectal Bundle|"Preoperative optimization of the nutritional status: Perform nutritional risk screening (NRS), measure albumin or prealbumin preoperatively and initiate nutritional support
~Preoperative showering with an antiseptic agent
~Administer preoperative antibiotic prophylaxis
~Hair removal in the operative field with clippers
~Peri-, intra-, and postoperative warming to maintain body temperature
~Peri- and intraoperative glucose control
~Usage of a wound protection device
~Change of gloves and instruments after anastomosis
~Anastomosis only with experienced senior surgeon present in theatre for any elective and emergency procedures"
15787838|NCT04550143|Other|Diaphragm ultrasound (DUS)|"DUS assessments of diaphragmatic thickness (TDI), thickness fraction (TFDI) and shear modulus (SMDI), this last measured by shear-wave elastography (SWE), will be performed for both right and left hemi-diaphragms.
~A landmark between the 8th and 10th intercostal space in the mid-axillary or antero-axillary line, 0.5-2 cm below the costophrenic sinus, will be used. Here, the diaphragm can be seen as the less echogenic structure between two echogenic lines; TDI (cm) will be the calculated as the distance between the two lines at the end of expiration and TFDI as the rate of change between end-expiration and end-inspiration thicknesses (TFDI = thickness at end inspiration - thickness at end-expiration / thickness at end-expiration, %).
~SMDI will assess muscle's stiffness. For each image, a region of interest covering the widest possible surface of diaphragm and allowing an acquisition frequency of 2Hz will be set; results will be retrieved in kilopascals (kPa)."
15787839|NCT04550143|Other|Peripheral Muscle Ultrasound (PMUS)|"PMUS assessments of quadriceps rectus femoris (RF) muscle cross-sectional area (CSARF), echogenicity (ECHORF) and shear modulus (SMRF), this last measured by shear-wave elastography (SWE), will be performed.
~Probe will be placed perpendicularly to the anterior plane of the thigh, in 2 anatomical points, as follows:
~(i) in the midpoint between the anterior superior iliac spine and the upper pole of the patella and (ii) the border of the lower 1/3 and upper 2/3 between the anterior superior iliac spine and the upper pole of the patella.
~CSARF (cm2) will be calculated by outlining the area under the muscle hyperechoic line (aponeurosis). For ECHORF (differences in grey-scale images), the analysis of a region of interest (ROI) of 2cm x 2cm will be performed.
~For SMRF (kPa), a ROI covering the widest possible area of the RF and allowing an acquisition frequency of 2Hz will be set for analysis.
~All assessments will be performed with minimal compression and a copious amount of water-gel."
15787840|NCT04550143|Other|Airway occlusion pressure (P0.1)|"P0.1 is the pressure developed in the occluded airway 100 milliseconds after the onset of inspiration. Its use doesn't require any additional equipment since it can be easy measured by using patient's ventilator.
~For the measurement itself, patients will be in semi-recumbent position (head elevation between 30° and 45°) with knee extended in neutral position and will be asked to stay as relaxed as possible. After 5 minutes breathing without any interruption or disturbance, 4 measurements will be observed and recorded as displayed on the ventilator screen."
15787841|NCT04550143|Other|Medical Research Council (MRC) sum score|"This is a manual muscle strength testing tool, used very often in the ICU setting. It's based on the assessment of the following muscle groups: shoulder abduction, elbow flexion, wrist extension, hip flexion, knee extension, and dorsiflexion of the ankle, all scored bilaterally. Muscle strength is graded as follows: 0, no visible/palpable contraction; 1, visible/palpable contraction without movement of the limb; 2, movement of the limb, but not against gravity; 3, movement against gravity; 4, movement against gravity and some resistance; 5, normal.
~The sum score ranges between 0 and 60 (between 0 and 5, in 12 muscle groups), with a score <48 indicating the presence of weakness."
15787842|NCT04550130|Device|TLA Gut™|The medical device to be investigated is named Tailored Leukapheresis (TLA) Gut™. The device comprises a column that has been designed for extracorporeal leukapheresis to specifically remove chemokine (C-C motif) receptor 9 (CCR9) expressing immunological cell populations including human leukocyte antigen DR isotype (HLA-DRhi ) monocytes from the circulation. This is achieved by integrating a strong affinity binding between the gut homing cell receptor, CCR9, and its cognate ligand, thymus-expressed chemokine (TECK) or chemokine ligand 25 (CCL25). Those blood cells that express CCR9 will bind to presented Biotinylated thymus-engineered chemokine (bTECK) on the matrix by a strong receptor ligand interaction, remaining bound to the matrix. Blood cells that do not express the receptor pass through the column unchanged and are returned to the patient.
15787843|NCT04550117|Procedure|Insertion of Intraspinal pressure monitor|A fiberoptic pressure monitoring wire will be placed into the subarachnoid space at the site of traumatic spinal cord injury
15787844|NCT04550104|Radiation|Radiotherapy|Administered as 30 fractions of 2Gy. Total 60 60Gy. Administered once daily monday to friday.
15787845|NCT04550104|Drug|Olaparib Oral Tablet [Lynparza]|Oral tablet
15787846|NCT04550104|Drug|AZD1390|Oral tablet
15787847|NCT04550104|Drug|TBD Compound 1|
15787848|NCT04550104|Drug|TBD Compound 2|
15787849|NCT04550104|Drug|TBD Compound 3|
15787850|NCT04550091|Device|Detection of ascites using CT|Role Of Multi-detector Computed Tomography In Differentiation Between Different Types Of Ascites
15787851|NCT04550078|Dietary Supplement|Calcium Carbonate|Subjects receive a single-dose of 800 mg calcium as calcium carbonate provided in 6 capsules with a standardized breakfast served in the morning.
15787852|NCT04550078|Dietary Supplement|Calcium Permeate|Subjects receive a single-dose of 800 mg milk calcium as calcium permeate provided in 6 capsules with a standardized breakfast served in the morning.
15787853|NCT04550078|Dietary Supplement|Placebo|Subjects receive a single-dose of 0 mg calcium as placebo with maltodextrin provided in 6 capsules with a standardized breakfast served in the morning.
15787854|NCT04550065|Behavioral|Digital game|A digital family game with theme-based mini games (epidemic prevention, exercise, diet, communication and parenting)
15787855|NCT04550039|Device|Body-weight-supported treadmill|Gait training performed on treadmill with overhead harness providing necessary body-weight-support with assistance from trained physical therapist
15787856|NCT04550039|Device|Ekso Bionics EksoNR exoskeleton|Gait training performed overground in EksoNR exoskeleton with assistance from trained physical therapist
15787857|NCT04550026|Other|HTP inhalation|Sham inhalation for 30 minutes
15787858|NCT04550013|Other|Heavy-Slow Resistance training|Resistance training for knee extensors. The exercise will be performed at 80% of 1 RM and slowly (6 s/repetition).
15787859|NCT04550013|Other|Low-Load Blood Flow Restriction training|Resistance training for knee extensors. The exercise will be performed at 30% of 1 RM and with a relative Artery Occlusion Pressure of 80%
15787860|NCT04549987|Device|Space closure without changing working archwire monthly|Upper premolar space closure using the same 0.019X0.025 stainless steel archwire every month
15787861|NCT04549987|Device|Space closure withchanging working archwire monthly|Upper premolar space closure using new 0.019X0.025 stainless steel archwire every month
15787862|NCT04549974|Other|Heat exposure|Participants will be exposed to heat exposure via a water-perfused suit to increase internal body temperature by 1.5 degrees Celsius.
15787863|NCT04549961|Other|Nutrition|type and amount of food eaten or type and amount of oral nutritional supplements as well as enteral or parenteral nutrition
15787864|NCT04549948|Procedure|0.017X0.025 Stainless steel|Leveling curve of Sppe using 0.017X0.025 SS archwire
15787865|NCT04549948|Procedure|0.019X0.025 Stainless steel|Leveling curve of Sppe using 0.019X0.025 Stainless steel archwire
15787866|NCT04549948|Procedure|0.021X0.025 B-Titanium archwire|Leveling curve of Sppe using 0.019X0.025 B-Titanium archwire
15787867|NCT04549935|Drug|Dextenza|Dextenza 0.4mg
15787868|NCT04549935|Drug|Topical Prednisolone|Standard of care topical drop treatment
15787869|NCT04549922|Drug|ISIS 721744|1.2 mL of ISIS 721744 subcutaneous once after randomization
15787870|NCT04549922|Drug|Normal Saline|1.2 mL subcutaneous
15787871|NCT04549909|Other|collect retrospectively data|Analyse the incidence of BPL in these populations
15787872|NCT04549896|Procedure|CT scan|Surgeon will perform a CT scan before the surgery procedure (CTO PCI) in order to increase the success rate of the surgery.
15787873|NCT04549896|Procedure|No CT scan|The surgery procedure (CTO PCI) will be performed following the standard of care, meaning that the surgeon will not perform a CT scan before the surgery procedure.
15787874|NCT04549883|Other|Theoretical practical educational session|1 Theoretical practical educational session of 15 Min about the importance of low back control during hip extension. Includes anatomical issues and one practical exercise in quadruped position
15787875|NCT04549870|Drug|Roflumilast|Treatment according to national roflumilast guidelines
15787876|NCT04549857|Behavioral|aromatherapy|"The intervention measures were taught by the researchers to perform self-massage on both wrists and finger joints in the experimental group and the comfort group, using 5ml each time (2.5ml each for one hand), 10 minutes each time (5 minutes for each hand), three times a week, It lasts for three weeks. The massage steps refer to dōTERRA's Aroma Touch Hand Technique. Before self-massage is performed, a professional must first ensure that the execution process is correct and the professional will use the phone to follow up weekly.
~The experimental group used the base oil (sweet almond oil) to add Atlantic cedar, sweet marjoram and sweet orange essential oils. The essential oils were blended into 5% massage oil at a ratio of 3:1:1.
~The placebo group only used base oil (sweet almond oil).
~The control group did not provide any interventional measures and only received conventional treatment."
15787877|NCT04549844|Drug|Bupivacaine|"After adequate pre-oxygenation, Induction will be accomplished with the injection of propofol 2 mg/kg and Fentanyl 1 µg/kg IV. Endotracheal intubation will be facilitated by the intravenous injection of 0.5 mg/kg atracurium. General anesthesia will be maintained by mechanical ventilation with oxygen and air (50:50), isoflurane.
~Patients in peribulbar block group will receive lidocaine 2%, bupivacaine 0.5% and hyaluronidase with total volume 0.06 ml/kg keeping the ratio 1: 1 between lidocaine combined with hyaluronidase and bupivacaine by 24 Gauge needle after induction of general anesthesia and before start of surgery."
15787878|NCT04549831|Genetic|Massive parallel sequencing of host genome|Massive parallel sequencing and genotyping of host genome of individuals infected with SARS-CoV-2 and showing different clinical outcomes from asymptomatic to severely affected patients in order to identify the genetic determinants of severe COVID-19 and the genetic protective factors.
15787879|NCT04549818|Device|sacral neuromodulation|Sacral neuromodulation group, N=22 will be treated with Stimulation of the sacral nerve roots by placement of a lead and generator, typically using an implanted InterStim® device that provides constant electrical stimulation to the S 2, 3 and 4 nerve roots, for 2-week trial stimulation
15787880|NCT04549805|Diagnostic Test|Computed Tomography Coronary Angiography|In order to optimise the quality of the Computed Tomography Coronary Angiography scan images, participants might be given tablets or an injection (e.g. beta-blockers, calcium channel antagonist, ivabradine) to slow their heart rate and glyceryl trinitrate (GTN) following local protocol guidance.
15787881|NCT04549792|Drug|Ustekinumab|Each subject will receive ustekinumab at Baseline (Day 0) and Months 1, 3, 5, 7, 9, and 11. During the LTE, subjects will receive injections every 8 weeks for one year: Month 13, Month 15, Month 17, Month 19, Month 21, and Month 23. Subjects will come back in for a follow-up visit at Month 25 for an end of study visit (no drug administration).
15787882|NCT04549779|Procedure|Low volume interscalene brachial plexus block|ultrasound-guided interscalene brachial plexus block with 5 ml levobupivacaine 0.25%
15787883|NCT04549779|Procedure|Intermediate volume interscalene brachial plexus block|ultrasound-guided interscalene brachial plexus block with 10 ml levobupivacaine 0.25%
15787884|NCT04549779|Procedure|High volume interscalene brachial plexus block|ultrasound-guided interscalene brachial plexus block with 15 ml levobupivacaine 0.25%
15787885|NCT04549766|Other|calculate PRECISE DAPT score using clinical data|calculate PRECISE DAPT score using clinical data in STEMI patients after PPCI
15787886|NCT04549753|Device|Transcranial direct current simulation|Four sessions of stimulation over C3 (patient with left-sided lesion) or C4 (patient with right-sided lesion) based on 10-20 system
15787887|NCT04549740|Diagnostic Test|salivary alpha amylase level measurement|Saliva samples will be obtained to estimate salivary alpha amylase
15787888|NCT04549727|Other|Organoids creation|Organoids are created from discarded tissue
15787889|NCT04549714|Procedure|High AI in paroxysmal atrial fibrillation|Patients with paroxysmal AF will receive pulmonary vein vestibule ablation with high AI value, the AI target value for the front wall and the top wall is 550, and the rear wall and the lower wall are 400.
15787890|NCT04549714|Procedure|Middle AI in paroxysmal atrial fibrillation|Patients with paroxysmal AF will receive pulmonary vein vestibule ablation with middle AI value, the AI target value for the front wall and the top wall is 500, and the rear wall and the lower wall are 350.
15787891|NCT04549714|Procedure|Low AI in paroxysmal atrial fibrillation|Patients with paroxysmal AF will receive pulmonary vein vestibule ablation with low AI value, the AI target value for the front wall and the top wall is 450, and the rear wall and the lower wall are 300.
15787892|NCT04549701|Other|CAVAL US-guided Therapy|Patients randomly assigned to this group will receive a daily CAVAL US exam guided decongestive therapy accessible to treating medical team, in addition to the standard care.
15787893|NCT04549701|Other|Standard of care|Standard of care will be provided.
15787894|NCT04549688|Procedure|high-intensity focused ultrasound, HIFU|see above
15787895|NCT04549675|Behavioral|Sun Safe Partners Online|Sun Safe Partners Online has 4 individual-focused modules and 4 couple-focused modules focusing on skin cancer prevention education and sun protection.
15787896|NCT04549675|Behavioral|Generic Online Sun Safety Information intervention|4 links to sent to participants from (1) The Skin Cancer Foundation's Skin Cancer Prevention guidelines, (2) the Centers for Disease Control and Prevention's information on risk factors for skin cancer, (3) the American Academy of Dermatology's information on how to select an appropriate sunscreen, and (4) The Skin Cancer Foundation's information on sun protective clothing. Participants were emailed a link to one of the resources each week for 4 weeks.
15787897|NCT04549662|Dietary Supplement|Active A|Powdered formula containing whey protein and arginine
15787898|NCT04549662|Dietary Supplement|Active B|Powdered formula containing whey protein
15787899|NCT04549662|Dietary Supplement|Lipid bolus|Omega-3 fatty acids
15787900|NCT04549662|Dietary Supplement|Placebo oil|Control placebo oil that does not contain omega-3 fatty acids
15787901|NCT04549649|Other|Dual triggering|Adding GnRH agonist (0.2 mg Triptorelin (Decapeptyl; Ferring GmbH) to routine oocyte triggering (two ampoules of Ovitrelle®, 250 μg/0.5 ml, Merck, Serono, Inc) is defined as dual triggering.
15787902|NCT04549636|Other|V/Q SPECT-CT|At visits 1 and 2, ventilation will be assessed by 99mTc Technegas SPECT ventilation scan and perfusion will be assessed by 99mTc Macroaggregated Albumin SPECT perfusion scan.
15787903|NCT04549636|Other|St. George's Respiratory Questionnaire (SGRQ)|At visits 1 and 2, quality of life will be evaluated using the St. George's Respiratory Questionnaire (SGRQ).
15787904|NCT04549636|Other|mMRC (Modified Medical Research Council) Dyspnea Scale|At visits 1 and 2, dyspnea will be evaluated using the mMRC (Modified Medical Research Council) Dyspnea Scale.
15787905|NCT04549636|Other|Six-minute walk test (6MWT)|At visits 1 and 2, exercise capacity will be evaluated using the six-minute walk test (6MWT).
15787906|NCT04549636|Other|Spirometry|At visits 1 and 2, spirometry will be performed to quantify the forced expiratory volume in one second (FEV1), the forced vital capacity (FVC) and FEV1/FVC.
15787907|NCT04549636|Other|Plethysmography & DLCO|At visits 1 and 2, plethysmography and the diffusing capacity of the lung for carbon monoxide (DLCO) will be performed.
15787908|NCT04549636|Other|Airwave Oscillometry|At visits 1 and 2, airwave oscillometry will be performed to obtain resistance (R) and reactance (X) at 5 Hz (R5) and 19 Hz (R19). The resonance frequency (fres), area above the reactance curve (AX) and the heterogeneity of obstruction (R5-19) will be derived from R and X.
15787909|NCT04549623|Device|Novel end-tidal CO2 monitoring device|Apart from SpO2 and respiratory motion monitoring, the EtCO2 monitoring device is used to detect CO2 from nose and mouth simultaneously.
15787910|NCT04549623|Device|SpO2 and respiratory motion monitoring|Finger SpO2 and ECG-based respiratory motion monitoring are used during operation.
15787911|NCT04549610|Dietary Supplement|HMB supplementation|Group taking oral HMB supplementation in a blinded capsule form.
15787912|NCT04549610|Dietary Supplement|Placebo treatment|Group taking oral supplementation with placebo (corn starch) in a blinded capsule form.
15787913|NCT04549597|Drug|Tenapanor|Use of tenapanor
15787914|NCT04549584|Diagnostic Test|Vimentin/pan CK stain|Vimentin/pan CK stain positive/negative
15787924|NCT04549558|Diagnostic Test|Multimodal Ultrasound|Multimodal Ultrasound (Strain Ultrasound Elastography, Conventional Grey-Scale Ultrasound, Color-Doppler Ultrasound, and Ultrasound Guided Fine Needle Aspirate) on Axillary Lymph Nodes
15787925|NCT04549545|Device|Vivaer ARC Stylus|The Vivaer procedure will be performed in the study clinic using the Vivaer ARC Stylus and Aerin Console. The Vivaer ARC Stylus is a disposable handheld device capable of delivering bipolar radiofrequency energy to tissue when connected to the Aerin Console radiofrequency generating device. Participants in this study will undergo bilateral treatment of the nasal valves in a single study session.
15787926|NCT04549545|Device|Sham|The sham control procedure will be performed in the study clinic using the Vivaer ARC Stylus while audible sounds that accurately simulate the Aerin Console's active treatment are produced even though RF energy is not being generated or delivered. All other aspects of the procedure will be the same as used for the active treatment, including administration of anesthetic agent(s).
15787927|NCT04549532|Behavioral|Targeted Multidomain|Participants in the T-MD intervention group will be prescribed targeted interventions to address each individual's symptoms, impairments, and functional limitations in the areas of anxiety/mood, cognitive, migraine/headache, ocular, vestibular, sleep, autonomic. The length of the intervention period will be 4 weeks or until RTA, whichever comes first.
15787928|NCT04549532|Behavioral|Behavioral Management|1.3. Usual Care (Controls) Group Participants randomized to the usual care (control) group will receive standardized (i.e., all participants in this group will receive the same interventions) behavioral management strategies that include activity, hydration, nutrition, sleep, and stress management strategies.
15787929|NCT04549519|Other|No intervention|No intervention / Compare the difference in batting mechanics and bat-swing velocity in baseball players with good and poor lumbopelvic control
15787930|NCT04549493|Behavioral|Exposure Therapy|Exposure Therapy is used to reduce the symptoms of PTSD
15787931|NCT04549480|Drug|Bosutinib capsule|100 mg dose of bosutinib pediatric capsule
15787932|NCT04549480|Drug|Bosutinib tablet|100 mg dose of bosutinib tablet
15787935|NCT04549454|Behavioral|FITSTART+ PBI|Personalized normative feedback on other parents behaviors + alcohol-specific parenting advice + general parenting advice
15787936|NCT04549454|Behavioral|General Parenting Advice|General parenting advice
15787937|NCT04549441|Procedure|Distal radius fracture plating surgery|We performed open reduction and plating surgery for the distal radius fracture.
15787938|NCT04549428|Drug|Atezolizumab|Intravenous infusion every 21 days, until disease progression, intolerance or loss of clinical benefit.
15787939|NCT04549415|Drug|Metformin Hydrochloride|"patients were divided into 2 groups: 1st group was on lifestyle modification (LSM), 2nd group on regimen LSM+ metformin (1000 g b.i.d) during 12 months"
15787940|NCT04549415|Other|lifestyle modification|Lifestyle modification Standard Principles
15787941|NCT04549402|Other|Mirror Therapy group|The intervention protocol will be carried out under the same environmental conditions and, as far as possible, on time. The intervention will last 4 weeks, with a periodicity of 7 weekly sessions. In total there will be 28 sessions lasting between 15 and 45 minutes depending on the number of joints affected.
15787942|NCT04549402|Other|Video group|The intervention protocol will be carried out under the same environmental conditions and, as far as possible, on time. The intervention will last 4 weeks, with a periodicity of 7 weekly sessions. In total there will be 28 sessions lasting between 15 and 45 minutes depending on the number of joints affected.
15787943|NCT04549389|Device|Low intensity shockwave therapy|LiST will be applied in the perineum of the patients by using Dornier Aries 2 shockwave machine (5000shockwaves per session, energy level 7)
15787944|NCT04549376|Drug|Povidone-Iodine 0.4% NI|Povidone iodine (PVP-I) nasal irrigation at concentration of 0.4%
15787945|NCT04549376|Drug|Povidone-Iodine 0.5% NI|Povidone iodine (PVP-I) nasal irrigation at concentration of 0.5%
15787946|NCT04549376|Drug|Povidone-Iodine 0.6% NI|Povidone iodine (PVP-I) nasal irrigation at concentration of 0.6%
15787947|NCT04549376|Drug|Povidone-Iodine 0.5% NS|Povidone iodine (PVP-I) nasal spray at concentration of 0.5%
15787948|NCT04549376|Drug|Povidone-Iodine 0.6% NS|Povidone iodine (PVP-I) nasal spray at concentration of 0.6%
15787949|NCT04549376|Other|Placebo comparator: DW-NI|Nasal irrigation will be provided by Distilled water
15787950|NCT04549376|Other|Placebo comparator: DW-NS|Nasal spray will be provided by Distilled water
15787951|NCT04549363|Drug|Belantamab mafodotin|Belantamab mafodotin is a first-in-class immunoconjugate that targets B cell maturation antigen (BCMA), which is highly expressed on malignant plasma cells.
15787952|NCT04549350|Other|PSQI|Assessment of sleep quality using Pittsburgh Sleep Quality Index (PSQI): It is a simple tool which assess the sleep quality over one month period. It included seven components with a global PSQI score > 5 is indicative of poor sleep quality
15787953|NCT04549337|Behavioral|Exercise training|"Feasibility and safety of 3 different training protocols will be tested. Therefore the intervention is three different exercise protocols (4X4, 6X1, and 10-20-30). The exercise workload is set according to the patients HRmax or wattmax from a VO2max test at the baseline testing. All training protocols have a duration of 38 minutes and start with a 10-minute warm up and a 3-7-minute cool-down period. The intervals in the training protocols are interspersed with a 3-minute active rest. Therefore the three exercise protocols are matched on duration, and they all fall within the category of high-intensity-interval training.
~The accumulated time spend with a heart rate >85% of HR max will be evaluated to determine the intensity."
15787954|NCT04549311|Drug|Antibiotic 1 arm (amoxicillin + clavulanic acid)|Prescription of antibiotics (amoxicillin + clavulanic acid) after incision and drainage of perianal abscess.
15787955|NCT04549311|Drug|Antibiotic 2 arm (ciprofloxacin + metronidazole)|Prescription of antibiotics (ciprofloxacin + metronidazole) after incision and drainage of perianal abscess.
15787956|NCT04549298|Other|No interventions|No interventions - observational study
15787957|NCT04549285|Biological|Human Cord Tissue Mesenchymal Stromal Cells (hCT-MSCs)|"Human Umbilical Cord Tissue-derived Mesenchymal Stromal Cells (hCT-MSC):
~hCT-MSCs is an allogeneic cell product manufactured from donated umbilical cord tissue that is digested and expanded in culture, cryopreserved and banked. Doses contain 2x10^6 cells/kg (up to a maximum dose of 100x10^6 cells) diluted in plasmalyte-A with 5% HSA to a volume of 20-40mL."
15787958|NCT04549272|Other|No interventions|No interventions - observational study
15787959|NCT04549259|Behavioral|Group-Based Social Support|This intervention involves weekly support group calls facilitated by a licensed counselor or therapist for 8 consecutive weeks. The calls will last approximately 90 minutes and will include 5-8 individuals per group. Groups will follow pre-determined topic areas, with participants encouraged to explore their feelings about the difficulties associated with normal aging, being HIV-positive, and living with HIV/AIDS as an older adult. Therapists will facilitate mutual support among group members, encourage greater openness and emotional expressiveness, and help participants to improve their social and family support and enhance their quality of life. This intervention is an adaptation of Telephone Supportive-Expressive Group Therapy (Heckman et al., 2013).
15787960|NCT04549259|Behavioral|HIV Stigma Reduction|"This intervention involves weekly support group calls facilitated by a licensed counselor or therapist for 6 consecutive weeks. The calls will last approximately 60-90 minutes and will include 5-8 individuals per group. This intervention is grounded in minority stress theory and will use cognitive-behavioral strategies to help empower participants to cope with stressful and stigmatizing experiences. Intervention components may include minimizing self-stigmatizing attitudes, reducing engulfment, developing a sense of future and hope, and developing and pursuing meaningful life goals. This intervention is an adaptation of Ending Self Stigma (Lucksted et al., 2011)."
15787961|NCT04549259|Behavioral|Strengths-Based Case Management (SBCM)|The investigators have adapted an individually-tailored strengths-based case management (SBCM) intervention to help address the multiple structural barriers faced by rural older PLH. The adapted intervention, delivered by trained research staff, will include two 60-minute telephone-based SBCM counseling sessions with shorter follow-up phone calls to check-in on progress and help patients navigate identified barriers. The case manager will provide tailored sessions based on individually-identified needs and proximal life stressors. Capitalizing on participants' personal strengths, case managers will help empower participants to navigate issues related to employment, insurance, mental health, housing, or transportation. This may include assistance understanding, applying for, and accessing benefits or programs.
15788078|NCT04548258|Device|electric intraoral weilding|weilding metal framework to the implants in completely edentulous maxilla using electric weilding device intraorally
15787962|NCT04549259|Behavioral|Personalized Technology Detailing|Participants will be called by a technology-fluent study staff member, who will assess the current state of their technology literacy, access, and use. Detailing will focus on advancing the participant along the technology use cascade (using the internet, possessing a device and service to access internet at home, using the internet to access their electronic health record and pharmacy services, seeking HIV-related information, and finding social support). Each participant will be provided with personalized assistance based on their local and personal circumstances. Because of the individualized advice provided, there will be a range of contacts between 1 and 5, at customized intervals. Detailing protocols include the option of providing the participant with a tablet including cellular service (for 3 months) when in-home internet service is not available or is cost prohibitive.
15787964|NCT04549207|Drug|Bone modifying agent|Use of bone modifying agent
15787965|NCT04549194|Biological|Blood collection|A blood sample will be collected before during and after the treatment.
15787966|NCT04549194|Drug|L-Tyrosine 500 Mg|The participants will be administered 4 capsules of L-Tyrosine 500 mg per oral route daily over 1 month.
15787967|NCT04549194|Behavioral|Psychological questionnaires|"The participants will fill in several psychological questionnaires before, during and after treatment administration:
~Life Event Checklist
~Moral injury
~Posttraumatic Checklist
~Burnout Assessment Tool
~State-Trait Anger Expression Inventory-2
~Ruminative Response Scale - Reconsidered
~Deployment Risk and Resilience Inventory-2
~Questionnaire about tobacco use"
15787968|NCT04549194|Device|Photoplethysmography|Photoplethysmography recording will be performed before during and after the treatment.
15787969|NCT04549194|Drug|Placebo|The participants will be administered 4 capsules of Lactose 500 mg (placebo) per oral route daily over 1 month.
15787970|NCT04549181|Behavioral|Phase II: Problem-Solving for Rural HF Dyads|Participants in the Intervention Group will be trained to use a 4-step problem-solving process based on the Theory of Social Problem-Solving (TSPS) to manage HF-related problems collaboratively over 12-weeks. The core belief of TSPS is effective problem-solving requires a positive problem orientation (i.e., viewing problems as a challenge versus a threat) and elicits rational problem-solving versus avoidance or impulsivity/carelessness. Dyadic problem-solving follows from a positive problem orientation and involves accurate problem identification, generation of appropriate potential solutions, active decision-making, and solution implementation and evaluation. The goal of this dyadic intervention is to move HF dyads toward a positive problem orientation and use of rational problem-solving strategies that support greater patient and family caregiver-contributed HF self-care.
15787974|NCT04549142|Other|There is no intervention|There is no intervention
15787975|NCT04549129|Behavioral|Breastfeeding education video|"An introductory video (15 minutes) gives an overview of these ABCs (video titled Term baby which are further taught through brief text summaries (150-200 words) and short instructional videos (2-6 minutes)."
15787976|NCT04549129|Behavioral|Breastfeeding website|"The website firstdroplets.com is designed for prenatal education, focusing on the ABCs of breastfeeding that come before D (delivery) - attachment (latch), breastmilk production, and calories (transfer of milk to baby)."
15787977|NCT04549129|Behavioral|Usual breastfeed education|The usual breastfeed education includes brief counseling by study staff and provision of handouts on latch/positioning and common first week breastfeeding advice
15787978|NCT04549116|Drug|Progesterone-IBSA Injectable Solution|Progesterone-IBSA 25mg, twice daily (BID) SC Injection every 12 hours
15787979|NCT04549116|Drug|Progesterone Vaginal Gel with Applicator|Crinone 8%, 90 mg, QD intravaginally
15787980|NCT04549116|Drug|Placebo Vaginal gel with applicator|Vaginal gel Placebo, once daily (QD) intravaginally
15787981|NCT04549116|Drug|Placebo injectable solution|Placebo injectable solution, BID SC Injection every 12 hours
15787983|NCT04549090|Drug|QL (quadratus lumborum) block administration|Fo the QL block group, they will be receiving bilateral QL block. A total of 40ml of 0.25% bupivacaine (Marcaine) and 10ml of liposomal bupivacaine (Exparel) will be administered
15787984|NCT04549064|Diagnostic Test|diagnosis of pancreatic cancer|Diagnosis of pancreatic cancer based on the concentration of serum biomarkers
15787985|NCT04549051|Device|Tenex|Local anesthetic plus tenex into the coaracohumeral ligament for adhesive capsulitis
15787986|NCT04549051|Drug|Local anesthetic|Only local anesthetic into the coracohumeral ligament for adhesive capsulitis
15787987|NCT04549038|Other|12-16 hour nutrition|Cases will receive their nutrition over a period of 12-16 hours, with minimum 8 hours of fasting and maximum 12 hours of fasting. Feeding will begin in morning hours unless otherwise directed by an investigator or registered dietician.
15787988|NCT04549025|Drug|JTX-4014|Specified dose on specified days
15787989|NCT04549025|Drug|Vopratelimab|Specified dose on specified days
15787990|NCT04549012|Drug|Tranexamic acid|comparison between effect of oxytocin alone and tranexamic acid and oxytocin in reducing blood loss after CS
15787991|NCT04549012|Drug|Oxytocin|Oxytocin
15788079|NCT04548258|Device|casting|casting metal framework
15787992|NCT04548999|Drug|Ocrelizumab|The actual higher dose of ocrelizumab will be assigned to participants based on their body weight at baseline: 1200 mg (participants's body weight <75 kg) or 1800 mg (participant's body weight >/=75 kg). The first dose of ocrelizumab will be administered as two 600 mg or 900 mg intravenous (IV) infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 1200 mg or 1800 mg IV infusion every 24 weeks.
15787993|NCT04548999|Drug|Ocrelizumab|Ocrelizumab will be administered at a dose of 600 milligram (mg) every 24 weeks. The first dose of ocrelizumab will be administered as two 300 mg intravenous (IV) infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 600 mg IV infusion every 24 weeks.
15787994|NCT04548999|Drug|Antihistamine|Premedication with oral or IV antihistaminic drug (i.e., diphenhydramine 50 mg or an equivalent dose of an alternative) will be administered prior to each ocrelizumab infusion.
15787995|NCT04548999|Drug|Methylprednisolone|Premedication with 100 mg of methylprednisolone (or equivalent) will be administered by IV infusion prior to each ocrelizumab infusion.
15787996|NCT04548986|Device|Aktiia.product|The participants wear Aktiia.bracelet for the duration of the cardiac rehabilitation program. The device is initialized once per week.
15787997|NCT04548973|Drug|Esketamine|Esketamine
15787998|NCT04548973|Drug|Normal saline|2ml normal saline
15787999|NCT04548960|Other|cancer patients|Blood sample RNA_seq at time of diagnostic, best response and relapse ; Biopsy Exom_seq and RNA_seq at time of diagnostic and relapse Immulogical Profiling at time of diagnostic, best response and relapse
15788000|NCT04548947|Procedure|Cold snare polypectomy in conjunction with a submucosal injection|The cold snare polypectomy in conjunction with a submucosal injection is a procedure during which the endoscopist resects the colorectal polyps during a colonoscopy, without any electrocautery.
15788001|NCT04548934|Device|Personal protective equipment (PPE)|Wearing of PPE (FFP3 mask, gloves, eye protection, long-sleeved gown)
15788002|NCT04548934|Device|No Personal protective equipment (PPE)|Standard CPR without wearing PPE
15788003|NCT04548908|Diagnostic Test|Serelogy testing, RT PCR|Serology testing for all the participants and RT PCR for participants with symptoms
15788004|NCT04548895|Device|Observational measurement of biometric data. No change to health care provided.|"Emfit devices will be installed once after enrollment under each participant's mattress and left to record automatically without further intervention. The participants will wear their Biostrap wristbands consistently, ideally 24 hours a day, 7 days a week, for 2 months.
~A virus panel will be upon enrollment (baseline) and then every two weeks (± 3 days, or on the closest convenient sampling day if the LTCF is testing all residents on the same day) for a maximum of 5 times during the two-month period. Using polymerase chain reaction or next generation sequencing, the virus panel will detect COVID-19 and 12 other common respiratory viruses that may cause similar symptoms and similar biometric signatures. These include influenza A and B, parainfluenza types 1 through 4, respiratory syncytial virus, non-COVID coronavirus, rhinovirus, adenovirus, bocavirus and metapneumovirus."
15788005|NCT04548882|Device|Calypso Knee System|The Calypso Knee System is an extra-capsular knee implant designed to fill the therapeutic gap between conservative care and more invasive surgical interventions for knee osteoarthritis.
15788006|NCT04548869|Drug|CDX-0159|Administered intravenously
15788007|NCT04548856|Procedure|Microsurgical clipping|Subjects randomized to surgical therapy will receive treatment from one neurosurgeon expert in surgery for ruptured aneurysms.
15788008|NCT04548856|Procedure|Endovascular embolization|Subjects randomized to endovascular therapy will be treated by one endovascular expert in such treatment. Endovascular treatment will include all modern accepted surgical techniques.
15788009|NCT04548843|Procedure|Bone Marrow mobilization|"During four days before the apheresis, Neupogen (G-CSF) at a dose of 10 microgram per kilogram will be administered subcutaneously in the morning (days -6 to -3 of cell therapy). In addition, Mozobil (Plerixafor) at a dose of 0.24 milligram per kilogram will be administered subcutaneously approximately 4 hours before apheresis initiation.
~A fifth dose of Neupogen (G-CSF) will be administered just prior to the apheresis"
15788010|NCT04548843|Procedure|Apheresis|Apheresis will be performed two days prior to MNV-BM-PLC infusion. During this procedure, patient's peripheral blood will be collected by apheresis
15788011|NCT04548843|Biological|MNV-BM-PLC infusion|"The MNV-BM-PLC (autologous CD34+ cells enriched with placenta-derived allogeneic mitochondria) infusion will be performed by standard IV procedure.
~The dosing interval between patients will be at minimum 2 weeks."
15788012|NCT04548830|Procedure|Transbronchial cryobiopsy|After enrollment, and pre-treatment procedures are complete, patients will undergo flexible bronchoscopy with a therapeutic bronchoscope under general anesthesia via an advanced airway at Memorial Hospital in an inpatient or outpatient setting.
15788013|NCT04548804|Diagnostic Test|ECG-Imaging|A body surface potential mapping and a cardiac + low dose CT-scan
15788014|NCT04548791|Biological|Coagulation Factor VIIa variant|Single intravenous dose and ascending doses of subcutaneous injection of MarzAA, followed by a fixed dose of MarzAA for the treatment of bleeding episodes
15788015|NCT04548778|Diagnostic Test|BÜHLMANN fPELA assay|BÜHLMANN fPELA assays are immunoassays for the quantitative determination of fecal pancreatic elastase in human stool samples.
15788016|NCT04548765|Behavioral|Letter|Recipients receive a letter promoting CRC screening.
15788017|NCT04548765|Behavioral|Loss Frame and Fear Appeals|The letter is enhanced with language that frames the situation in terms of losses. It also uses fear appeals by showing the risks of colorectal cancer, while also showing that screening is an achievable means to address those risks.
15788018|NCT04548765|Behavioral|Transparency|The letter explains why the kit was sent, which makes the purposes of the mailing clear to the recipient.
15788019|NCT04548765|Behavioral|Default Effect and Presentation of Alternatives|The pros and cons for screening with FIT kits and colonoscopy are presented. By showing an additional option, the table frames the FIT kit as the default option (since they are included in the mailer). In this situation, inaction is no longer the default option. Changing the default option increases the chance that the FIT kit is used. In addition, another viable alternative is provided (colonoscopy), which still contributes to the goal of the project (getting screened).
15788080|NCT04548245|Device|EEG|EEG
15788081|NCT04548232|Procedure|LSG|bariatric surgery
15788082|NCT04548219|Drug|Mirikizumab|Administered SC.
15789106|NCT04540120|Drug|dapansutrile capsules|Hard opaque capsules containing 250 mg of API.
15788020|NCT04548765|Behavioral|Enhanced Fear Appeals and Decoy Effect|Comparisons of the mortality rates between screening with FIT kits, colonoscopy, and inaction (waiting for symptoms to appear) are displayed. Inaction is presented as a decoy, which has worse outcomes than either of the screening options. Due to this contrast, the inclusion of the decoy increases the appeal of the other screening options.
15788023|NCT04548726|Device|Sapien 3 Transcather Aortic Valve Implant|Implant of a Ballon Expandable Aortic Valve Sapien 3 (Edwards Lifesciences, Irvine, CA, USA) prosthesis via a transcatheter procedure.
15788024|NCT04548726|Device|Myval Transcather Aortic Valve Implant|Implant of a Ballon Expandable Aortic Valve Myval (Meril Life Sciences Pvt. Ltd., India) prosthesis via a transcatheter procedure.
15788025|NCT04548713|Device|4% EDTA|Sterile Catheter Lock Solution
15788026|NCT04548713|Device|Saline|Saline Lock Solution
15788027|NCT04548700|Drug|Dose-finding stage: Liposomal mitoxantrone hydrochloride, Cyclophosphamide, Vincristine and Prednisone|"Drug: Liposomal mitoxantrone hydrochloride (12 mg/m2, 15 mg/m2, 18 mg/m2) will be administered by an intravenous infusion on day 1 of each 28-day cycle.
~Drug: Cyclophosphamide (750 mg/m2) will be administered by an intravenous infusion on day 1 of each 28-day cycle.
~Drug: Vincristine (1.4 mg/m2 with 2 mg as the maximum dose) will be administered by an intravenous injection on day 1 of each 28-day cycle.
~Drug: Prednisone (100 mg/d) will be taken orally from day 1 to day 5 of each 28-day cycle."
15788028|NCT04548700|Drug|Dose-expansion stage: Liposomal mitoxantrone hydrochloride, Cyclophosphamide, Vincristine and Prednisone|"Drug: Liposomal mitoxantrone hydrochloride (at RP2D) will be administered by an intravenous infusion on day 1 of each 28- or 21-day cycle.
~Drug: Cyclophosphamide (750 mg/m2) will be administered by an intravenous infusion on day 1 of each 28- or 21-day cycle.
~Drug: Vincristine (1.4 mg/m2 with 2 mg as the maximum dose) will be administered by an intravenous injection on day 1 of each 28- or 21-day cycle.
~Drug: Prednisone (100 mg/d) will be taken orally from day 1 to day 5 of each 28- or 21-day."
15788029|NCT04548687|Procedure|carbon dioxide insufflation|Carbon dioxide insufflation at a rate of 5 l / min. through the Redon drainage during cardiac surgery (minimally invasive or repeated) during cardiopulmonary bypass
15788030|NCT04548687|Procedure|No carbon dioxide insufflation|standard methods of deaeration of cardiac cavities: manual method, change in body position, through the cannula of the ascending aorta, through the drainage of the left ventricle
15788031|NCT04548674|Other|Whiteness HP 35%|Single application of 45 minutes on the buccal surfaces of third molars, with an average thickness of 1 mm
15788032|NCT04548674|Device|Whiteness HP 35% + LASER|A dose of LASER (60 J / cm2, for 16 seconds) was applied at two points, one point in the cervical region and another in the center of the buccal surface of the third molars, using visible infrared LASER therapy (Photon III / DMC, São Carlos, SP, Brazil), with a wavelength of 808 nm, and AsGaAl, as an active medium.
15788033|NCT04548674|Other|Whiteness HP 35% + CPP|Topical application of casein phosphopeptide amorphous calcium phosphate fluoride CPP-ACPF (My Paste Plus, Recaldent, GC, USA) with the aid of a microbrush (KG Sorensen, SP, Brazil) in a passive way for 5 minutes.
15788034|NCT04548674|Other|Whiteness HP 35% + NANO|A topical application of nanohydroxyapatite (Nano P FGM, SC, Brazil) was performed with the aid of a microbrush (KG Sorensen, SP, Brazil) in a passive way for 5 minutes after teeth whitening.
15788039|NCT04548635|Device|VR-PAT|Smartphone-based Virtual Reality Pain Alleviation Tool (VR-PAT) via a lightweight, mobile VR headset
15788040|NCT04548622|Device|Magstim Rapid 2 system triggering Magstim Super Rapid system|Week 1 treatment includes rTMS for 5 sessions to both the left and right Wernicke's area (BA22) synchronous with rTMS to opposite hemisphere middle temporal cortex (BA21). Week 2 treatment includes rTMS given for 5 sessions with positions reversed (e.g., if Wernicke's stimulation was on the left during Week 1, position of rTMS will switch to the right side during Week 2 and vice-versa). As in Week 1, active rTMS will also be given synchronously to the opposite hemisphere middle temporal cortex. Weeks 3 and 4 include 10 stimulation sessions to the configuration of sites producing greater improvement in comparing results of Week 1 and Week 2. rTMS for each stimulation session will be given at 1-Hertz (once per second) for 16 minutes without interruption.
15788041|NCT04548609|Device|Transcranial Direct Current Stimulation|In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
15788083|NCT04548206|Other|Pilates training|The program consisted of core-based Pilates exercises on the mat for 60 minutes.
15788084|NCT04548206|Other|control|The program consisted of progressive relaxation exercises at home.
15788085|NCT04548193|Behavioral|Behavioral Dietary Intervention|Receive live phone call
15788086|NCT04548193|Behavioral|Behavioral Dietary Intervention|Receive IVR phone messages
15788087|NCT04548193|Other|Educational Intervention|Receive educational materials
15788088|NCT04548193|Other|Questionnaire Administration|Ancillary studies
15788409|NCT04545554|Drug|Romosozumab|Participants will receive 3 doses of romosozumab via a subcutaneous (SC) injection.
15788042|NCT04548596|Diagnostic Test|Transcranial Doppler|"In this study, the investigators will primarily use the monitor mode of the Transcranial Doppler (TCD, non-invasive FDA approved device) to record cerebral blood flow velocity (CBFV) signals from the Middle Cerebral Artery and Internal Carotid Artery. TCD data and intracranial pressure (ICP) data will be collected in the following four scenarios. Each recording is up to 60 minutes in length:
~External ventricular drain (EVD) closed to drainage for a 24 hour period as part of the EVD weaning protocol per standard of care (SOC): The Initial reading will be done within 4 hours of EVD closing. The second reading will be done within 4 hours of anticipated removal of EVD.
~EVD closed most of the time and opened to drainage when the ICP becomes elevated per SOC
~EVD with Intra-Parenchymal fiber optical ICP sensor per SOC
~Intra-Parenchymal fiber optical ICP sensor per SOC"
15788043|NCT04548583|Drug|Remestemcel-L|adult allogeneic bone marrow derived mesenchymal stem cell product for the treatment of medically refractory Crohn's colitis
15788044|NCT04548583|Drug|Remestemcel-L|adult allogeneic bone marrow derived mesenchymal stem cell product for the treatment of medically refractory Crohn's colitis
15788045|NCT04548583|Other|Placebo|Normal saline
15788046|NCT04548570|Procedure|approximation of both rectus muscles|closure of both rectus muscle before closure of rectus sheeth
15788047|NCT04548557|Biological|intravenous immunoglobulin therapy|It is passive immunization therapy. Plasma therapy is subjected to moderate to severe patients specially, while all effected individuals can take benefit of immunoglobulin therapy because dose of immunoglobulins can be controlled
15788048|NCT04548544|Behavioral|Training for Awareness, Resilience, and Action (TARA)|This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA)
15788049|NCT04548531|Behavioral|Shared Decision Making|"The decision aid is a paper information sheet presenting the pros and cons of three screening options (colonoscopy, stool-based tests, and postponing cancer screening until next year).
~The decision coaching is a structured interview to help patients clarify their preference for screening test and to support them in implementation (whether scheduling colonoscopy, ordering stool test or seeking additional advice from specialist)."
15788050|NCT04548518|Biological|GPO Tri Fluvac vaccine|Each dose of Tri Fluvac contains a total of 45 micrograms (μg) hemagglutinin (HA) per 0.5 ml dose (15 μg HA per strain per dose), to be administered by intramuscular (IM) injection. Tri Fluvac is manufactured and formulated into a multiple-dose vial vaccine (2 doses) using thimerosal at relatively low concentration as preservative (≤ 5.75 μg mercury/ dose). Each 0.5 ml dose of vaccine may contain residual amounts of ovalbumin (≤ 1.0μg), formaldehyde (≤ 100μg), tween 80 (≤ 0.9μg), triton x-100 (≤0.05μg) and gentamicin (≤0.075μg).
15788051|NCT04548518|Biological|Licensed influenza vaccine|The comparator licensed influenza vaccine is a seasonal trivalent inactivated split virion influenza vaccine recommended for Southern Hemisphere in 2020
15788052|NCT04548492|Other|Survey|to assess and validate how healthcare professionals can trigger or inhibit the use of modern technology applications in home isolation
15788053|NCT04548479|Device|PEP bottle|PEP bottle: it will be performed with a bottle of distilled water and a plastic tube, where the patient breathes against a resistance during expiration.
15788054|NCT04548466|Device|PEP bottle|
15788055|NCT04548453|Device|uterine electromyography|Multichannel uterine electromyography will record uterine biosignals during labor.
15788056|NCT04548440|Drug|Sintilimab|Route of administration: Intravenous
15788057|NCT04548440|Drug|Nab paclitaxel|Route of administration: Intravenously over 30min
15788058|NCT04548440|Drug|Cisplatin|Route of administration: Intravenous
15788059|NCT04548427|Drug|CKD-352|Eye Drop
15788060|NCT04548427|Drug|Diquafosol Sodium 3%|Eye Drop
15788061|NCT04548414|Other|No.|This is an observational study with no intervention.
15788062|NCT04548401|Drug|Antiplatelet Drug|aspirin and/or clopidogrel or ticagrelor
15788063|NCT04548388|Other|rehabilitation|"A specialist physiotherapist in neurological rehabilitation provided the Bobath approach individually to each patients in both groups. Bobath approach included 3 days a week over a total of 12 sessions for four weeks. The Bobath approach consisted of about individual one hour session.
~In addition to the Bobath approach, the subjects in the study group received WBV for 20 minutes a day, 2 days a week. The frequency of the device was increased by 5 Hz every week, starting the treatment with 30 Hz. Whole body vibration application was performed on a platform (Power Plate Pro5®) that provides vertical vibration. Two different practice positions were chosen as standing and semi-squatting. In order to prevent muscle fatigue, the set consisting of 1 minute of application - 1 minute of rest in each position was applied for a total of 10 minutes with 5 repetitions"
15788064|NCT04548375|Device|SCS|Conventional SCS implants approved through all payors(government and private) for FDA approved indications
15788065|NCT04548362|Other|Meat arm|Randomised sequence of pork, beef, chicken meat, and an egg white/pea combination
15788066|NCT04548362|Other|Starchy foods arm|Randomised sequence of boiled potato, fried potato, potato crisps, and boiled white rice
15788067|NCT04548349|Drug|Altreno|Acne patients will be assigned to Altreno once daily.
15788068|NCT04548349|Drug|Benzoyl peroxide|Acne patients will be assigned to BPO leave-on gel once daily.
15788069|NCT04548336|Behavioral|Motor Imagery|Motor imagery group will have to imagine motor gestures of static and dynamic balance
15788070|NCT04548336|Behavioral|Action observation|Action observation group will have to observe static and dynamic equilibrium motor gestures
15788071|NCT04548336|Behavioral|Placebo group|This group will watch a video of nature without a human component.
15788072|NCT04548323|Behavioral|Motor imagery|Subjects will perform motor imagery tasks on the motor gestures of running and walking.
15788073|NCT04548310|Other|Muscles Fatigue|An exhaustion protocol that reduces knee joint flexor and extensor torque will be applied.
15788074|NCT04548297|Other|Assessment|Assessments of foot sole sensation, joint position sensation, attention, fatigue, body awareness, and physical activity level
15788075|NCT04548284|Drug|Glucocorticoids|Periorbital injection of glucocorticoid. Once every 3 weeks, the number of injections was determined according to the condition of the eyes during the follow-up.
15788076|NCT04548271|Drug|Camrelizumab|Anti-PD-1 targeted immunotherapy
15788077|NCT04548271|Drug|Apatinib|A small-molecule vascular endothelial growth factors receptor (VEGFR) tyrosine kinase inhibitor
15789107|NCT04540120|Drug|placebo capsules|Hard opaque capsules containing 0 mg of API.
15788089|NCT04548154|Other|Proximal Resistance Training|Participants will be prescribed 5 categories of resistance exercises, and each category will have a series of exercises to select from. Two will target hip abduction, two will target trunk muscles, and one will target functional resistance training for the hip and trunk during walking-related tasks such as multi-directional resisted walking. Dosing will be based on guidelines for MS. Strengthening exercises will begin with 3 sets of 12-15 reps at 15 rep-max load (RM) and progress to 3 sets of 8-10 reps at 10-12 RM. Endurance exercises requiring a static hold will progress from 3 sets of 15-20 second holds to 30-second holds. Functional resistance will be dosed to improve muscular endurance: 3 sets of 15-20 reps based on form fatigue.
15788090|NCT04548141|Other|Questionnaire|Scoring of the IPAQ is performed according to references. Scoring of the SAPHIR has been submitted for copyright protection (involves a series of 23 additions)
15788091|NCT04548128|Device|HeartMate 3 Left Ventricular Assist System (HM3 LVAS)|This clinical trial investigates implant of the HM3 LVAS by techniques other than full median sternotomy.
15788092|NCT04548115|Behavioral|ARTISAN Condition|Youth and senior participants will be randomly paired and engage in the 5-weekly, 3-hour ARTISAN intervention as dyads (totaling 15 hours of intervention). In the first four weeks of the ARTISAN, dyads will engage in themed museum tours facilitated by a docent (45min), guided storytelling (45 min) and professionally-led art-making (45 min). The remaining time (45 min) is allocated for session breaks, session introduction/closing, and buffer time for movement around the gallery. The final week involves an exhibition where participants share their artworks with the public and reflect on their experiences and artworks. The weekly session themes are as follows: Week 1: Discovering our National Heritage (Art medium: Clay); Week 2: Strengthening Social Bonds (Art medium: Acrylic Paints); Week 3: Overcoming Adversities and Resilience (Art medium: Beads); Week 4: Building Dreams and Aspirations (Art medium: Recycled Materials); Week 5: Sharing our Stories and Legacies (Community Showcase)
15788093|NCT04548115|Behavioral|Intergenerational Participatory Arts Condition|Youths and senior participants in this condition will be randomly paired and engage in a 5-weekly 45-minute group-based art activity conducted in a community space with 15 minutes of preparation/break time (totaling 5 hours of intervention). A professional artist or art therapist will facilitate art-making sessions with the participants in a community space, utilizing the same mediums that were used in ARTISAN. The weekly session themes are as follows: Week 1: Discovering our National Heritage (Art medium: Clay); Week 2: Strengthening Social Bonds (Art medium: Acrylic Paints); Week 3: Overcoming Adversities and Resilience (Art medium: Beads); Week 4: Building Dreams and Aspirations (Art medium: Recycled Materials); Week 5: Sharing our Stories and Legacies (Community Showcase)
15788094|NCT04548115|Behavioral|Intergenerational Art-space Condition|Youths and senior participants in this condition will engage in a 5-weekly 45-minute group-based curated museum tour that follow the ARTISAN themes with 15 minutes of preparation/break time, and conducted by a trained docent at the National Museum Singapore (totaling 5 hours of intervention).The weekly session themes are as follows: Week 1: Discovering our National Heritage; Week 2: Strengthening Social Bonds; Week 3: Overcoming Adversities and Resilience; Week 4: Building Dreams and Aspirations; Week 5: Sharing our Stories and Legacies.
15788095|NCT04548115|Behavioral|Intergenerational Storytelling Condition|Youths and senior participants in this condition will be paired to engage in a 5-weekly 45 minute group-based storytelling activity conducted in a community space with 15 minutes of preparation/break time (totaling 5 hours of intervention). Storytelling sessions will be conducted by a trained facilitator, and conversation starters from ARTISAN intervention will be used. The weekly session themes are as follows: Week 1: Discovering our National Heritage; Week 2: Strengthening Social Bonds; Week 3: Overcoming Adversities and Resilience; Week 4: Building Dreams and Aspirations; Week 5: Sharing our Stories and Legacies.
15788096|NCT04548115|Behavioral|Control Condition|Participants in this condition will engage in a 5-weekly 45 minute group-based physical activity session conducted in the community with 15 minutes of preparation/break time (totaling 5 hours of intervention). Physical activity was selected over basic psychosocial care to test the effects of inter-generational contact independent of arts and heritage-based engagements.
15788097|NCT04548102|Other|Fetal movement count|Pregnant women in the study group received verbal information regarding normal fetal movements (i.e. description of the changing pattern of movement as the fetus develops, normal sleep/wake cycles, and factors which may modify the mother's perception of movements such as maternal weight and placental position), and its importance to be followed during the third trimester. A chart for fetal movements counting provided and to ensure proper performance of this task, women telephoned once a week. They also asked to show the fetal movements chart to the researcher and the health care providers in each visit. Women followed according to her antenatal visits schedule till delivery.
15788098|NCT04548089|Behavioral|Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC)|Each Mindful-Compassion Art Therapy for Dementia Care (MCAT-DC) will focus on 3 major areas that cultivate self-care, resilience and communal support. The specific intervention structure include: Week 1 - Empowering Self-Care: Introduction to the science of stress, self-care, burnout, as well as the arts and mindfulness to cultivate resilience; Week 2 - Reflective Caregiving: Reflection of caregiving experiences that demonstrates strengths and challenges; Week 3 - Understanding Loss: Introduction to the science of loss, how grief can impair hope and wellbeing, and how self-compassion can help transform suffering into blessings.; Week 4 - Meaning Reconstruction: Reflection on caregiver identities, to elicit the lessons and wisdoms learnt, and to create renewed meaning to sustain their caregiving journeys. Guided mindfulness mediation will also be professionally recorded to form a daily take-home mindfulness mediation exercise for participants, each exercise will last 10-20 minutes.
15788099|NCT04548076|Other|Block group|Control group
15788100|NCT04548063|Other|6,000 word consent form|Mock consent form with consistent content in approximately 6,000 word length.
15788101|NCT04548063|Other|4,000 word consent form|Mock consent form with consistent content in approximately 4,000 word length.
15788102|NCT04548063|Other|2,000 word consent form|Mock consent form with consistent content in approximately 2,000 word length.
15788103|NCT04548050|Other|Nurses training|"Presentation of the benefits of colostrum and manual expression technique on a slide show and practical workshops for learning the manual expression technique on a fictitious breast.
~Presentation to all staff of a service protocol for early colostrum donation."
15788185|NCT04547309|Radiation|68Ga/18F-HER2 Affibody PET/CT scan|HER2 Affibody, labeled with PET radio-nuclide ( 68Ga or F-18) will be used as a molecular imaging tracer for PET/CT scan. All participants will undergo 68Ga/18F-HER2 Affibody PET/CT scan.
15788104|NCT04548037|Other|PET-CT examination|The subject is placed in supine position, the head immobilized in a headrest. The imaging sequence begins with a scout view (viewing angle 90 °, 120 kV, 20 mA), then an X-ray scan is performed for the attenuation correction (120 kV, 5 mAs per slice, pitch 0.531, collimation 40 mm , FOV 70) and diagnostic CT scan (120 kV, 100-250 mA: auto mA, pitch 0.531, 40 MM, DFOV 25, ASIR 60%, thickness 1.25 mm). Finally, the positron emission tomography is acquired: static in 3D mode for 15 minutes, 30 minutes after the injection of 18 FDG, the axial field of view is 25, the matrix in 256 x 256, OSEM reconstruction 6 iterations 24 subsets, attenuation correction, diffused, and PSF. Gaussian filter, cutoff frequency of 4. Obtaining forty-seven contiguous sections of 3.26 mm thick.
15788105|NCT04548024|Device|Short term monitoring|By using the Biobeat monitoring device, we will monitor CHF patients during an outpatient visit and during treatment with diuretics.
15788106|NCT04548011|Other|Acupuncture|The acupuncture treatment strategies in this study are based on traditional Chinese medicine theory and opinions from the acupuncture experts. The acupoints are bilateral Zhongwan（CV12）, Tianshu（ST25）, Neiguan（PC6）, Liangqiu（ST34）, Yanglinquan（GB34）, Zusanli（ST36）and Taichong（LR3）.All the acupoints will be localized according to the Nomenclature and Location of Acupuncture Points of the People's Republic of China. During the acupuncture treatment, the participants will be in supine position. After 75% alcohol pads sterilizing the skin around the acupoints routinely, the acupuncturists will use sterile disposable steel needles (0.3 mm×40 mm; Huatuo Brand, Suzhou Medical Appliance, China) to insert into the acupoints above. The acupoints will be inserted vertically at 13-40 mm with the manipulation of steady small lifting, thrusting, and twirling 3 times to induce a sensation of de qi (sourness, numbness, and heaviness).
15788107|NCT04547998|Procedure|Spray-On Skin™ Cells 1:20 with NB-UVB|Skin cell suspension at 3 expansion ratios (donor area : recipient area), prepared using the RECELL System, will be applied to an ablated (de-epithelialized) area of depigmentation, followed by targeted phototherapy using NB-UVB. Each participant will be randomized to receive treatment of a portion of their depigmented lesion with cell suspension prepared at 1:20
15788108|NCT04547998|Device|NB-UVB only|Each subject will serve as their own control, with a portion of the depigmented lesion receiving no RECELL treatment but receiving the same targeted NB-UVB as the investigational treatment area.
15788109|NCT04547985|Drug|Naltrexone HCl 50 MG Oral Tablet|Generic, oral tablet.
15788110|NCT04547985|Drug|Placebo|Composed of filler material and encapsulated to appear identical to naltrexone.
15788111|NCT04547972|Other|Higher-load resistance training|This intervention will have one arm and one leg of each participant training with ~80% of their one repetition maximum
15788112|NCT04547972|Other|Lower-load resistance training|This intervention will have one arm and one leg of each participant training with ~30% of their one repetition maximum
15788113|NCT04547959|Device|cervical interbody cage C-CURVE|ACDF: Anterior Cervical Discectomy and Fusion with a C-CURVE cage (in PEEK or Titanium)
15788114|NCT04547946|Drug|dabrafenib + trametinib|There is no treatment allocation. Patients administered adjuvant treatment with combination therapy of Dabrafenib (Tafinlar®) and Trametinib (Mekinist®) by prescription that have started before inclusion of the patient into the study will be enrolled.
15788115|NCT04547933|Diagnostic Test|Bladder diary|A 3-day bladder diary recording daily drinking fluid amount, daily urine amount, urgency and urinary incontinence episodes.
15788116|NCT04547907|Drug|Albumin binding paclitaxel+ trastuzumab+ patuzumab|Albumin binding paclitaxel 125 mg / m2 (1, 8, 15 days) + trastuzumab (8 mg / kg for the first loading dose and 6 mg / kg for the sequential maintenance dose) + patuzumab (840mg for the first loading dose and 420mg for the sequential maintenance dose) ，every 21 days for 6 cycles.
15788117|NCT04547907|Drug|Docetaxel+ carboplatin+ trastuzumab + patuzumab|Docetaxel 75 mg/m2 + carboplatin (AUC = 6) + trastuzumab(8 mg / kg for the first loading dose and 6 mg / kg for the sequential maintenance dose) + patuzumab (840mg for the first loading dose and 420mg for the sequential maintenance dose) ，every 21 days for 6 cycles.
15788118|NCT04547894|Drug|ASC09F|ASC09F (300 mg ASC09 and 100 mg Ritonavir) one tablet at a time, once per day, up to 7 days.
15788122|NCT04547855|Drug|anlotinib combined with dose-dense temozolomide|Temozolomide Capsule 150mg, p.o., qd, d1-7,15-21,4 weeks one cycle; Anlotinib hydrochloride capsule 12mg, p.o., qd, D1-D14; 3 weeks one cycle.
15788123|NCT04547842|Drug|Mirtazapine 30 MG|mirtazapine is given in arm M to prevent PONV
15788124|NCT04547842|Drug|Dexamethasone|Dexamethasone is given in arm D to prevent PONV
15788125|NCT04547829|Drug|pegylated recombinant human granulocyte-colony stimulating factor|The dosage was determined according to the patient's weight, 100 UG / kg each time; The method of administration: subcutaneous injection; The time of administration: 24-48 hours after the end of chemotherapy, once in each chemotherapy cycle.
15788126|NCT04547816|Procedure|Biofeedback therapy|Biofeedback therapy is a procedure when the patient is taught to make proper squeezing by adequate increase of intra-abdominal and rectal pressures and relaxation of the muscles of the pelvic floor. This procedure is widely described and is to be performed with the use of devices registered for this purpose Urostim and WPM Solar, MMS, the Netherlands
15788127|NCT04547816|Procedure|Tibial neuromodulation|TNM is a standard procedure that is previously described as an effective method to treat functional insufficiency of the anal sphincter. It acts on the lumbosacral nerve plexus with an electric current through the posterior tibial nerve of one of the patient's limbs. For the study purpose a registered device for electric therapy (BioBravo, MTR Plus Vertriebs GmbH, Germany) is to be used.
15788128|NCT04547816|Behavioral|Pelvic floor muscles training|"PFMT is a complex of 5 exercises aimed to make functional training of pelvic floor muscles. This complex does not require additional equipment. It may be performed at home. The patients will be trained to perform this complex of exercises by a healthcare provider.
~The complex of physical therapy consists of a single basic exercise for training coordinated muscle tension of abdominal wall and relaxation of the pelvic floor muscles, and 4 exercises to increase the contractility of pelvic floor muscles without additional involvement of the muscles of the abdominal wall. This allows to coordinate and consciously control the contraction and relaxation of the pelvic diaphragm. Initial course of training is 10 working days. Than patients continue the intervention for 6 months at home with online monitoring of the correctness and regularity of training."
15788129|NCT04547816|Behavioral|Diet modification|Diet modification play an important role in the regulation of colonic transit and defecation. Dietary factors may act through faecal bulk by additional stimulation of mechanoreceptors of the rectum. At the same time, adequate intake of vitamins (for example, B12) may improve electric conductivity of nerves and thus impact the tone of pelvic floor muscles. Among other factors known to affect functional state of pelvic floor muscles and colonic transit are dietary fibers, adequate intake of water, regular meal intake. For the study purposes, it is planned to provide standard recommendation based on the national recommended daily allowances according to patients' sex, age and physical activity level.
15788130|NCT04547803|Other|Standard of Care|Outpatient appointments and activities including radiologic procedures for discharging patients as standard of practice
15788131|NCT04547803|Other|Video Visit|15-20 minute Video visit with an advanced practice provider (nurse practitioner or physician assistant) approximately 2-5 days after discharge.
15788132|NCT04547790|Dietary Supplement|Psyllium|One level scoop (12.5mL) of 5.1g of psyllium fiber twice a day with 8 ounces water
15788133|NCT04547790|Dietary Supplement|Wheat Dextrin|One level scoop (12.5 mL) of 1.7g wheat dextrin fiber twice a day with 8 ounces water
15788134|NCT04547777|Drug|D2C7-IT|D2C7-IT intratumoral infusion
15788135|NCT04547777|Drug|2141-V11|2141-11 intratumoral infusion
15788136|NCT04547764|Drug|triple antibiotic paste (TAP)|root canal treatment of pulpally involved teeth.
15788137|NCT04547764|Drug|Vitapex (calcium hydroxide/iodoform paste)|root canal treatment of pulpally involved teeth.
15788138|NCT04547751|Other|targeted high-resolution mass spectrometry|"difference between the number of new substances identified using targeted analysis by liquid chromatography coupled with high-resolution mass spectrometry versus using targeted analysis. narcotics-new substance by liquid chromatography coupled with tandem mass spectrometry"
15788139|NCT04547738|Drug|TB treatment according to national guidelines|National clinics in Cameroon will initiate TB treatment according to national guidelines upon positive TB diagnosis
15788140|NCT04547725|Other|CRS followed by IP and systemic chemotherapies|Complete cytoreductive surgery (CRS) + normothermic intraperitoneal chemotherapy (N-IPEC) + systemic chemotherapy
15788142|NCT04547699|Combination Product|A single step culture medium|A single step culture medium (SSCM; Global, Life Global)+5mg/ml life global protein, without supplementation of CYK
15788143|NCT04547686|Behavioral|Smoke-Free Homes intervention|The adapted smoke-free homes intervention consists of five components, three interactive mailings and two coaching calls, focused on creating home and vehicle(s) smoking bans among smokers. The intervention is based on principles of Social Cognitive Theory and the Transtheoretical Model's stages of change. The rationale underlying the intervention is that creation of additional smoke-free environments will reduce situational and environmental cues to smoke, reduce opportunities and places to smoke, increase self-efficacy for quitting and increase motivation to quit. The intervention uses persuasion, role modeling, behavioral contracting and goal setting to move smokers through behavioral capability, outcome expectations and self-efficacy for strict smoke-free rules, creation of and compliance/enforcement with smoke-free rules, reduced cigarettes smoked per day, increased motivation to quit, increased quit attempts, and successful cessation.
15788144|NCT04547686|Behavioral|Standard Care|The usual care/control arm will receive mailed information on the QL (quitline - free cessation counseling offered to all Georgia residents by the state of Georgia), and a connection to the QL at their request. Follow-up will be at six and twelve months, including saliva cotinine validation for reported 7-day cessation.
15788145|NCT04547673|Diagnostic Test|rigid nasal endoscopes|The endoscope is introduced through the nasal passage to observe, in sequence, the posterior nostril, superior and posterior walls of the nasopharynx, torus tubarius, pharyngeal opening of the auditory tube, and Rosenmu¨ller recess. The imaging light mode is set to conventional WLI and subsequently switch to NBI during the procedure, and representative images are collected and preserve for further analysis. All lesions, detected by either WLI or NBI, are biopsied.
15788146|NCT04547660|Biological|Convalescent Plasma|Fresh frozen plasma collected by apheresis from recovered COVID-19 patients added to best supportive care.
15788147|NCT04547660|Other|Best Supportive Care|Any form of ventilatory support, extracorporeal membrane oxygenation, steroids, antibiotics and other supportive measures except for investigational interventions.
15788148|NCT04547647|Radiation|X- Ray|X-Ray with A-P and lateral view of the whole spine.
15788227|NCT04546984|Drug|HEC96719|Part 2：Mulltiple doses up to 10 days
15789108|NCT04540107|Drug|Hyperpolarized Carbon C 13 Pyruvate|Given IV
15788149|NCT04547634|Other|Therapeutic Exercise and Education|The intervention will consist of 30 minutes of strength exercises followed by 20 minutes of endurance with aerobic training, individualized based on the evaluations of muscular strength and endurance. Sessions lasted 1 hour, carried out twice a week, for 12 weeks. This intervention will be complemented by nutritional education.
15788150|NCT04547621|Device|Radiation|Intensity-modulated radiotherapy 20Gy/10fx
15788151|NCT04547621|Device|Radiation|Hypofractionated Stereotactic Radiotherapy 30Gy/5fx
15788152|NCT04547621|Drug|Temozolomide|Temozolomide 75 mg/m2 concurrently administered with RT.
15788153|NCT04547608|Other|The difference of the timing of rocuronium administration after propofol injection|The difference of the timing was rocuronium was administered immediately after propofol injection or when BIS score became below 60 after propofol administration.
15788154|NCT04547595|Other|Hypnosis|given by Expert in this method
15788155|NCT04547582|Device|Spinal cord stimulator|Spinal cord stimulator leads (2-3 leads) will be placed in the lumbar epidural space of lower limb amputees to determine if the patient experiences any pain reduction from spinal cord stimulation.
15788156|NCT04547569|Behavioral|Speech adaptation|Sensorimotor adaptation in speech
15788157|NCT04547569|Behavioral|Vibrotactile Discrimination|Vibrotactile Discrimination
15788158|NCT04547569|Other|fMRI|fMRI measurement of brain activity
15788159|NCT04547569|Behavioral|Speech production|Speech production task
15788160|NCT04547556|Diagnostic Test|BioFire|"A molecular rapid syndromic testing platform, using the following panels:
~BioFire FilmArray Respiratory Panel 2.1 plus (RP2.1plus)
~BioFire FilmArray Pneumonia Panel plus (PP)"
15788161|NCT04547543|Other|Videoconsultation|Patient randomized on video-consultation group will have a video-consultation with the investigator within 3 months after the randomization. During this consultation, the investigator performs a clinical interrogation in order to collect anthropometric parameters: (sex, age, weight, height, body mass index (BMI)), blood pressure (by blood pressure monitor at home), the level of physical activity (by Actimetry over 7 days), smoking status and alcohol status
15788162|NCT04547530|Dietary Supplement|Vitamin D|as above
15788163|NCT04547530|Dietary Supplement|Placebo|as above
15788164|NCT04547517|Other|Evaluation of Counselling competencies|To complete a set of questionnaires
15788165|NCT04547504|Drug|Pembrolizumab|Pembrolizumab 200 mg once every 3 weeks for a maximum of 35 cycles or until disease progression, death, unacceptable toxicity, or the Investigator's or the patient's decision to stop.
15788166|NCT04547504|Drug|Pembrolizumab and Chemotherapy drugs|"An induction therapy followed by a maintenance therapy.
~4 induction cycles every 3 weeks associating, on the first day of each cycle:
~Cisplatin 75mg/m² or carboplatin AUC 5mg/mL/min, pemetrexed 500mg/m² and pembrolizumab 200mg for non squamous NSCLC.
~Carboplatin AUC 6mg/mL/min, paclitaxel 200mg/m² and pembrolizumab 200mg for squamous NSCLC.
~After the 4 induction cycles, a maintenance therapy will be possible for patients who are responding or stable:
~Non squamous NSCLC: pembrolizumab and pemetrexed combination or either drug as monotherapy.
~Squamous NSCLC: pembrolizumab monotherapy.
~For pembrolizumab: treatment may be continued for a maximum of 35 cycles or until disease progression, death, unacceptable toxicity, or following the Investigator's or the patient's decision to stop.
~For pemetrexed, treatment may be continued until disease progression, death, unacceptable toxicity, or following the Investigator's or the patient's decision to stop."
15788167|NCT04547491|Device|HPI - hypotension prediction index|treatment of hypotension before the appearance following HPI algorithm
15788168|NCT04547491|Device|GDT|cardiac optimization and treatment of hypotension following standard clinical practice
15788169|NCT04547478|Diagnostic Test|low dose chest CT(LDCT)|cross sectioned muscle area of the 1st vertebrae level obtained by LDCT
15788170|NCT04547465|Diagnostic Test|Echocardiography|2D Speckle-tracking echocardiography
15788171|NCT04547452|Radiation|Stereotactic body radiation therapy|Sintilimab Combined with SBRT
15788172|NCT04547452|Drug|Anti-PD-1 antibody drug named Sintilimab|Sintilimab
15788173|NCT04547439|Drug|Melatonin|Melatonin 3 mg will be taken nightly for 8 weeks
15788174|NCT04547439|Other|Placebo|Placebo will be given nightly for 8 weeks
15788175|NCT04547426|Other|Wine with or without alcohol and snuff with or without nicotine|Two by two factorial of wine and snuff with meals
15788176|NCT04547413|Behavioral|STI/HIV Intervention Behavioral Intervention Program|In addition to standard of care STi/HIV counselling, participants in the intervention arm will also attend a 2-hour educational class and will receive monthly SMS/text messages to reinforce the content of the class.
15788177|NCT04547400|Other|assessment|Assessments of balance, gait, lower extremity position sense, and foot sole sense
15788178|NCT04547387|Device|Trans-carotid access revascularization with MicroNET covered stent implantation|Implantation of the micronet covered self-expanding carotid stent during temporary cerebral flow reversal achieved with direct common carotid artery puncture
15788179|NCT04547374|Other|GaH Intervention|"Patients in this cohort will be referred for management/intervention with GaH.
~However, the purpose of this program is not to define, control, or evaluate the specific details of the GaH process or procedure, but to evaluate its effectiveness as an alternative clinical care path in this setting. As such, the specific details and actions of the GaH care team in each patient interaction are left to their medical discretion."
15788180|NCT04547361|Drug|E2511|E2511 tablets.
15788181|NCT04547361|Drug|E2511 Matched Placebo|Placebo tablets matching E2511 tablets.
15788182|NCT04547348|Drug|Denosumab Injection|Injections made subcutaneously per standard description
15788183|NCT04547335|Drug|Voriconazole|This is an observational study and only the patients already on voriconazole treatment will be included in the study.
15788184|NCT04547322|Other|VR application group|During the transfer from the general surgery clinic to the operating room (3-5 minutes) and in the surgery waiting room, the VR aplication group were asked to wear a virtual reality headset (VR BOX 2) and headphones minimizing sound loss (Earpods with Apple Lightning Connector) that are compatible with mobile phones with IOS operating system. The VR headset and the headphones were controlled by a mobile phone (iPhone 7 Plus). The researchers had the patients watch three-dimensional videos (e.g. underwater world, museum trips, forest and park walks, beach trips, and space travel) for 10 minutes with their preferred background and relaxing music.
15788410|NCT04545554|Dietary Supplement|Calcium|All participants will receive daily supplements of elemental calcium.
15788186|NCT04547296|Drug|Sodium Bicarbonate Ringer's Solution|After the participants enter the operating room, radial artery puncture and catheterization were performed. The blood gas in the non-oxygen state was used as the basic value. A peripheral venous access was established in one upper limb, and the two groups were pre-dilated with sodium bicarbonate Ringer's solution or acetate Ringer's solution (30 min, 8 ml/kg). For laparoscopic surgery, adjust the PaCO2 value to 35-45 mmHg again 10 minutes after the establishment of the pneumoperitoneum. After the operation started, the two groups of participants were maintained with 4-5 ml/kg/h Ringer's solution during the operation. Blood gas was measured every hour after tracheal intubation during the operation, and the last blood gas was measured when the skin was sutured. When the blood gas pH <7.2, 5% sodium bicarbonate injection was given to correct it.
15788187|NCT04547283|Other|Usual Care|No clinical team recommendation, patients will remain in their natural choice of position
15788188|NCT04547283|Other|APPS|Clinical team guidance on prone positioning of patients
15788189|NCT04547270|Other|Ultrasound scan|Volunteers will have an ultrasound scanning of both sides of their neck lying in supine position. Sequentially the scanning will start from the base of the neck (supraclavicular fossa) to the upper part of the interscalene groove and then in the reverse direction to the supraclavicular fossa. Images will be recorded as video loops.
15788190|NCT04547257|Device|Seraph 100|Bloodfiltration with Seraph 100
15788191|NCT04547244|Other|echocardiographic optimization of CRTd|the patients after the implant of CRTd and during the follow-up will receive an echocardiography to optimize the atrio-ventricular and inter-ventricular delay, and to improve the effects of CRTd.
15788192|NCT04547231|Diagnostic Test|Fractional flow reserve, Coronary CT angiography|"Coronary CT angiography (CCTA) and measurement of fractional flow reserve (FFR) will be performed as part of routine clinical practice. The decision to perform CCTA before invasive angiography was at the judgment of the physicians in charge.
~Physiologic assessment includes delta FFR (lesion-specific) and FFR (vessel-specific) measurement. Delta FFR is defined as a pressure step up across the lesion. Coronary angiography and physiologic assessment will be analyzed by an independent core laboratory (Seoul National University Hospital, Clinical Trial Center, Seoul, South Korea).
~Stenosis and plaque features on CCTA will be analyzed by an independent CCTA core laboratory (Severance Cardiovascular Hospital, Seoul, Korea), and pericoronary and epicardial fat metrics (fat attenuation index, epicardial fat attenuation index, epicardial fat volume, etc.) will be obtained by an independent cardiac CT fat core laboratory (Tsuchiura Kyodo general hospital, Ibaraki, Japan)."
15788193|NCT04547205|Drug|AK109|AK109, 2、4、8、12mg/kg, IV, every 2 weeks (Q2W)
15788194|NCT04547192|Other|Improving initial care of the injured|Improvement in Care Processes
15788195|NCT04547179|Drug|Fremanezumab-Vfrm|Patients will receive three injections of Ajovy® if in the corresponding arm of the study.
15788196|NCT04547179|Device|BLAfit®|Usage of the BLAfit device, a fixed orthotic appliance that allows users to tone facial muscles with one minute usage per day
15788197|NCT04547179|Other|Saline|Patients will receive three injections of saline if in the corresponding arm of the study. This is a placebo meant to simulate the Ajovy® injection.
15788198|NCT04547166|Drug|HLX10/Placebo|4.5mg/kg, intravenous infusion (IV), every 3 weeks
15788199|NCT04547166|Drug|HLX04/Avastin|7.5mg/kg, IV, every 3 weeks
15788200|NCT04547153|Drug|5-fluorouracil|low dose
15788201|NCT04547153|Drug|Docetaxel|dose-sense
15788202|NCT04547140|Biological|Liquid Alpha1-Proteinase Inhibitor (Human)|Intravenous infusion 120 mg/kg
15788203|NCT04547140|Drug|Placebo|Intravenous infusion
15788204|NCT04547140|Drug|Standard Medical Treatment|SMT
15788205|NCT04547127|Biological|Convalescent anti-SARS-CoV-2 MBT Plasma|Intravenous infusion.
15788206|NCT04547127|Drug|Standard Medical Treatment|SMT
15788207|NCT04547114|Diagnostic Test|Multicapillary column coupled ion mobility spectrometry|sampling of nasal air via a foam cuffed oxygen catheter
15788208|NCT04547101|Drug|AK104|AK104，6 mg/kg IV，every 2 weeks (Q2W)
15788209|NCT04547088|Drug|Camrelizumab|Anti-PD-1 targeted immunotherapy
15788210|NCT04547088|Drug|Apatinib|A small-molecule vascular endothelial growth factors receptor (VEGFR) tyrosine kinase inhibitor
15788211|NCT04547075|Other|Turkish validity and reliability|"Contact with developers and formation of steering committee
~Translation from English to Turkish
~Back translation from Turkish to English
~Comparison of translation
~Review of translated versions.
~Reaching consensus and development of pilot version
~Testing in clinical setting
~Revision of pilot version
~Testing of final version"
15788212|NCT04547062|Drug|Tocilizumab|Administration of tocilizumab at day 8 of induction following a classical induction
15788213|NCT04547049|Drug|Cytarabine|4 mg/m2/day administered IV day -10 through -9.
15788214|NCT04547049|Drug|Busulfan|3.2 mg/kg/day administered IV day -8 through -6.
15788215|NCT04547049|Drug|Cyclophosphamide|1.8 g/m2/day administered IV day -5 through -4.
15788216|NCT04547049|Drug|Me-CCNU|250mg/m2 once administered orally on day -3.
15788217|NCT04547049|Drug|Rabbit antithymocyte globulin|1.5mg/kg/day administered IV day -5 through -2.
15788218|NCT04547049|Procedure|Allogeneic HSCT|Day 0
15788219|NCT04547049|Drug|Cyclosporin A|2.5 mg/kg/day administered intravenously from day -7, target: 200-300ng/mL. Usually tapered during the second month, and ended in complete withdrawal during the ninth month after transplantation.
15788220|NCT04547049|Drug|Mycophenolate Mofetil|500 mg/day administered intravenously from day -9, ended in complete withdrawal on day +100.
15788221|NCT04547049|Drug|MTX|15 mg/m2 administered intravenously on day +1, 10mg/m2 on day +3, +6, and +9.
15788222|NCT04547036|Device|XEN45|Up to 140 consecutive patients with preoperatively recorded endothelial cell counts will be summoned to a consecutive endothelial cell count record and measurement of central corneal thickness postoperatively.
15788223|NCT04547023|Behavioral|Fasting before gestational diabetes screen|Fasting for at least 6 hours before 1-hour gestational diabetes screen.
15788224|NCT04547023|Behavioral|Per oral intake of food and drink|Per oral intake of food and drink within 2 hours of gestational diabetes screen
15788225|NCT04547010|Dietary Supplement|Soy Isoflavone supplement|Participants received 60 mg of soy-isoflavone supplement per day.
15788226|NCT04546997|Diagnostic Test|Optical Coherence Tomography Angiography|Patients underwent non-invasive, fast, diagnostic imaging technique (optical coherence tomography angiography)
15788228|NCT04546971|Behavioral|Brief Intervention|Brief alcohol intervention delivered by telephone or videoconferencing focusing on advising participants to reduce drinking
15788229|NCT04546971|Behavioral|Telehealth Counseling|5 sessions of counseling on alcohol use based on Motivational Interviewing.
15788230|NCT04546971|Behavioral|Text messaging|A daily and then monthly text messaging program designed to help participants monitor drinking, set goals, and reinforce successful reduction or abstinence.
15788231|NCT04546958|Dietary Supplement|Whey protein supplements|Nutritional counseling and whey protein supplements for 3 months
15788232|NCT04546958|Other|Nutritional counseling|Nutritional counseling by dietitians for 3 months
15788233|NCT04546945|Diagnostic Test|CD56|detection of CD56 by flow cytometry
15788234|NCT04546932|Procedure|Lung-protective mechanical ventilation|Patients were provided with a tidal volume of 7 ml/kg IBW and an intraoperative 10 cmH2O in PEEP. Simultaneously, the alveoli were recruited applying a stepwise increase in PEEP (from 4 to 10 cmH2O for 3 breaths, 10 to 15 cmH2O for 3 breaths, and 15 to 20 cmH2O for 10 breaths) with maximum PIP = 50 cmH2O [24]. The recruitment maneuvers were performed right after intubation, 30 minutes after CO2 insufflation, then every hour, and finally before extubation.
15788235|NCT04546919|Other|sepsis|Body temperature higher than 38°C or lower than 36°C; Heart rate higher than 90/min; Hyperventilation evidenced by respiratory rate higher than 20/min or PaCO2 lower than 32 mmHg; White blood cell count higher than 12,000 cells/ µl or lower than 4,000/ µl.
15788236|NCT04546906|Biological|CD22 CAR-T|Biological: CD22 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis
15788237|NCT04546893|Biological|CD19 CAR-T|Biological: CD19 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;
15788238|NCT04546880|Other|Breathing exercises|"Breathing exercises consist of the techniques of diaphragmatic and pursed-lip breathing. During the diaphragmatic breathing, attention is focused on the correct abdominal breathing.
~The pursed-lip breathing is one step further to the diaphragmatic breathing and a technique designed to have control time and volume over breathing."
15788239|NCT04546880|Other|Stabilization exercises|"Training about the concepts of stabilization and abdominal bracing is given before starting to the study. The motor control tests for local muscles transversus abdominus and multifidi are performed after the training. The abdominal bracing test is performed in the quadruped position, in prone, and in hook lying position with the patient's spine supine with hips and knees flexed and knees in contact with the surface.
~The second stage consists of closed-chain segmental control exercises. It is a series of weight-bearing exercises are performed on stable and unstable surfaces. The last stage of the stabilization program is an open kinetic chain exercise to promote distal stability."
15788240|NCT04546867|Diagnostic Test|Sonographic based visualization of a pancreatic stent|As described above. All patients start with an ultasound-based approach to visualize pancreatic stents position. Depending on the findings, x-ray will be performed if no stent is visualized in the pancreatic duct or an esophagogastroduodenoscopy will be performed to remove the pancreatic stent and confirm sonographic findings if the pancreatic stent is displayed in situ.
15788241|NCT04546854|Behavioral|Appeals|Written text motivating participants to take up the seasonal influenza vaccination
15788242|NCT04546841|Biological|multipeptide cocktail|"Three groups of participant will be administered the multipeptide cocktail
~Part I: Age 18-55 at the time of screening
~Part II: Age 56-74 years at the time of screening
~Part III: Age ≥ 75 years at the time of screening"
15788243|NCT04546828|Drug|Gemcitabine, Cisplatin, and Nab-Paclitaxe|"Nab-paclitaxel 100mg/m2 in NS dilute to a total concentration of 5 mg/mL (DO NOT FILTER) over 30 minute IV infusion on days 1 and 8 repeated every 21 days, followed by:
~Cisplatin 25mg/m2 in 500 mL of NS over 60 minute IV infusion on days 1 and 8 repeated every 21 days, followed by:
~Gemcitabine 800 mg/m2 in 500ml over 30 minute IV infusion on days 1 and 8 repeated every 21 days ."
15788244|NCT04546815|Drug|Daptomycin|According to the severity of the disease, the site of infection and clinical response, the doctor makes a drug regimen of datoramycin.
15788245|NCT04546802|Drug|Elbasvir / Grazoprevir Oral Tablet|Elbasvir / Grazoprevir
15788246|NCT04546789|Drug|M2951 (BTK inhibitor)|Participants will receive a single oral dose of M2951 (BTK inhibitor).
15788247|NCT04546763|Device|Study Watch|The Study Watch is a miniaturized wearable device made with biocompatible contact materials containing various sensors capable of measuring physiological and environmental metrics.
15788248|NCT04546763|Device|Zio XT|The Zio XT Patch, the reference device, is a FDA-cleared single-patient use, continuously recording ECG monitor that can be worn up to 14 days.
15788249|NCT04546737|Other|Magnetic Resonance Spectroscopy (MRS).|This is a Nuclear Magnetic Resonance (NMR) technique which can detect the NMR signal allowing to measure under curves areas, amplitudes, ratios and concentrations of various metabolites contained in a biological tissue, in addition to water and lipids. This offers the possibility, in addition to the contribution of MRI imaging, to better characterize pathological processes (inflammatory, infectious, etc.) through spectral and metabolic changes that can be quantitatively evaluated. Spectroscopic measurements will be carried out with a mono-voxel spectroscopy using a PRESS [Point RESolved Spectroscopy] sequence with a short Echo Time (TE) of 35 ms, an intermediate TE of 144 ms and a long TE of 288 ms.
15788250|NCT04546724|Biological|VLA1553|Single intramuscular vaccination on Day 1 with VLA1553, a lyophilized live-attenuated Chikungunya vaccine candidate; 1x10E4 TCID50 per dose
15788251|NCT04546724|Biological|Placebo|Single intramuscular vaccination on Day 1 with Phosphate-Buffered Saline (PBS) as placebo
15788253|NCT04546698|Other|blood sampling|Analyse of expression modulation of 5-HT7 receptor in correlation with the immunological context, in 3 differents groups : 2 with multiple sclerosis patients, one healthy volunteers group
15788254|NCT04546685|Other|Usual Care|Participants who are randomized in the waitlist or usual care do not receive the study intervention and will be instructed to continue with the care they would normally receive as part of their ongoing clinical care. Upon completion of the 3-month study, participants in the waitlist will be invited to enroll in the Empowered Relief class.
15788324|NCT04546269|Procedure|Fully-guided vs. conventionally guided implant placement|Patients randomized to implant placement planned virtually based on a CBCT and a surface scan vs. implant placement based on a wax-up on gypsum casts
15788325|NCT04546256|Drug|Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg/Respirent|2 inhalations of Test and Reference product in each study period
15788255|NCT04546685|Behavioral|Empowered Relief|The participants will attend the Empowered Relief class offered online via Zoom. The class is designed to treat pain catastrophizing in people with chronic pain. Class participants will learn self-management skills and develop a personalized plan to use the skills every day. Participants will receive an audio file (Relaxation Response) post-class. The class provides patients rapid access to actionable skills for symptom management and pain relief.
15788256|NCT04546672|Drug|Sugammadex|At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg actual body weight through an intravenous line with brisk flow
15788257|NCT04546672|Drug|Neostigmine|At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg actual body weight to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be coadministered with Neostigmine at a dose of 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered
15788258|NCT04546659|Other|Retrowalking|Treatment of retro-walking including supervised 10 min retro-walking training with 5 min of warm-up and cool down on a flat surface at their comfortable speed
15788259|NCT04546659|Other|Conventional Therapy|Treatment of conventional therapy involve Isometric Quadriceps exercise, SLR, Isometric hip adduction exercises, Terminal knee extension exercise 1 set of 10 Reps twice a day.
15788260|NCT04546646|Other|Elastic Band Exercises|Resistance exercise will be performed using theraband. The color of the band denotes the degree of elasticity and resistance level(yellow , red ,green ,blue, black or silver).Exercise load in terms of individual yielding elasticity (band color) in resistance training will set at a level that a patient perceived as somewhat hard, which is equivalent to a 13-grade rating (moderate intensity exercise) on the RPE, According to American College of Sports Medicine. For each exercise movement 3 sets of 10 repetitions of gentle concentric and eccentric contractions through the full range of motion will be slowly performed using a yellow Thera band initially. The exercise intensity will be increased when the patient is able to achieve a perceived yield strength corresponding to a 13- grade rating on the RPE scale.
15788265|NCT04546607|Other|Nuvastatic TM (C5OSEW5050ESA) 1000 mg|Nuvastatic TM is a patented polymolecular botanical medicine made from Lanctos 75TM which is a proprietary high potency herbal standardized extract.
15788266|NCT04546581|Biological|Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG)|Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG) is derived from the plasma of individuals who recover and develop neutralizing antibodies. Participants will receive a single infusion.
15788267|NCT04546581|Other|Placebo|Participants will receive a single infusion of the placebo (saline).
15788268|NCT04546581|Drug|Remdesivir|Remdesivir will be given to participants in both groups as standard of care (SOC).
15788269|NCT04546568|Device|Servo control (closed-loop automatic control of the inspiratory fraction of oxygen (FiO2)) - Leoni plus CLAC|"FiO2 adjustments will be made by the Leoni plus CLAC (Closed-Loop Automated oxygen Control) ventilator (Leoni plus, Löwenstein Medical, Germany).
~Manual adjustments of the inspired oxygen fraction can additionally be made as per standard care."
15788270|NCT04546568|Device|Servo control (closed-loop automatic control of the inspiratory fraction of oxygen (FiO2)) - IntellO2 OAM|"FiO2 adjustments will be made by the IntellO2 Oxygen Assist Module (OAM) for Precision Flow (IntellO2, Vapotherm, USA).
~Manual adjustments of the inspired oxygen fraction can additionally be made as per standard care."
15788271|NCT04546555|Device|Dual chamber pacemaker|Dual chamber pacemaker implantation with Bachmann's bundle lead and His bundle lead placement.
15788272|NCT04546555|Other|Accelerated Physiologic Pacing|The lower rate limit will be programmed to an individualized heart rate.
15788273|NCT04546555|Other|Nocturnal Pacing|In addition to adjustment of the lower rate limit to an individualized heart rate, nocturnal pacing a moderate HR elevation of 110bpm will be implemented between 8pm and 6am.
15788275|NCT04546529|Device|Trans-spinal Magnetic Stimulation (TsMS)|Patients undergoing real TsMS with coil
15788276|NCT04546529|Device|Sham Trans-spinal Magnetic Stimulation (TsMS)|Patients undergoing placebo TsMS with coil
15788277|NCT04546516|Device|HYAcorp Lips and HYAcorp Face|Dermal filler injection to different facial areas
15788278|NCT04546503|Procedure|Continuous Regional analgesia|"Aseptic placement of one or two tunnelized CPNB at the level of the nerves or plexus of the traumatized limb (s), Nervestimulation and ultrasound guidance by trained operator.
~Continuous infusion of ropivacaine 0.2% at 1mL/10 Kg /H
~+ General anaesthesia"
15788279|NCT04546503|Procedure|Control Group|General anaesthesia without regional analgesia
15788280|NCT04546490|Other|Pressure Release technique|Manual therapy technique used by the treatment of Myofsacial Trigger points. The therapist will apply it with the first and second finger on the previously marked Myofascial Trigger Point and increasing the pressure as he perceives a reduction in the resistance offered by the soft tissue under the finger
15788281|NCT04546490|Other|Ischemic pressure technique|Manual therapy technique by making pressure in Myofascial Trigger Point. The therapist will apply it with the first and second finger on the previously marked Myofascial Trigger Point. This is performed until the patient's tolerance, when he refers a decrease in pain or have a correct adaptation to the perceived pain increase the pressure to a new painful barrier.
15788323|NCT04546282|Other|Description of the molecular alterations detected in blood samples of patients treated by osimertinib|Description of the molecular alterations detected in blood samples of patients treated by osimertinib. This test is usualyy performed routinely to detect conventional mutations including EGFR T790M. We performed panel of genes screeining based on next generation sequencing. Thius, iIn some cases, new mutations can be detected by this assay.
15788326|NCT04546256|Drug|ADVAIR DISKUS® 500/50|2 inhalations of Test and Reference product in each study period
15788327|NCT04546243|Procedure|resection group|patients received VATS
15788282|NCT04546477|Device|Stent implantation|"Procedure can be conducted via either contralateral or antegrade approach. After a successful target lesion crossing, predilate the lesion using either plain old balloon angioplasty (POBA) or (if necessary) any available specialty balloon. The inflated diameter of the balloon should approximate the diameter of the vessel just distal to the lesion. Proper vessel preparation should achieve diameter of 1:1 to healthy vessel (with ≤20% residual stenosis, as per operator's assessment). Adjunctive debulking devices are prohibited.
~Final stent selection should be confirmed after a proper vessel preparation, considering the reference vessel diameter (RVD) for the optimal 1:1 stent-to-vessel sizing. The implanted dual layer length would encompass the entire lesion with the micromesh, covering it from healthy to healthy tissue. Post-dilatation of the stent for more optimal placement may be done at operator's discretion, using standard angioplasty with uncoated balloon."
15788283|NCT04546464|Behavioral|Therapeutic Recreation Program|"The experimental recreation program, which consisted of two sessions per week and lasted approximately
~1 hour each session, lasted for 8 weeks between May 2019 and June 2019 for the adolescents in the experimental group. The Therapeutic Recreation Activity Program, which consists of 16 sessions, is organized according to the self-determination and entertainment development model. This model aims to provide individual development and prosperity by creating an entertaining environment with therapeutic recreation. According to the degree of enjoyment, activity improves freedom of choice, preferences and ability to express oneself. Pleasure is a feeling that the participant feels deeply during therapeutic recreation. Provides entertainment experience. Pleasure increases individual motivation to participate, as well as making the best use of physical, social and emotional conditions"
15788284|NCT04546451|Behavioral|Music practice|Patients will be trained to play a simple instrument (tongue-drum) in a group setting using different musical styles.
15788285|NCT04546451|Behavioral|Psychomotor therapy|Patients will be trained in body awareness and a wide range of of movement activities.
15788286|NCT04546451|Behavioral|Social animation|Patients will perform varying activities, for instance: developing self-awareness, brief discussions about actual topics, games, simple crafting.
15788287|NCT04546438|Device|miraDry®|"MiraDry is a noninvasive method that uses microwave technology to destroy sweat glands.
~In this study we evaluate a higher energy level with a newer generation device, in respect with side effects and number of treatments (one or two interventions)."
15788288|NCT04546425|Biological|20-valent pneumococcal conjugate vaccine|20-valent pneumococcal conjugate vaccine
15788289|NCT04546425|Biological|13-valent pneumococcal conjugate vaccine|13-valent pneumococcal conjugate vaccine
15788290|NCT04546412|Device|Vitrification and thawing|Vitrification using the Cryotop® - Open System followed by thawing
15788305|NCT04546386|Procedure|Endoscopic endonasal pituitary surgery|Surgical treatment consisted of an endoscopic endonasal approach using a rigid 0-degree endoscope, 18 cm in length and 4 mm in diameter
15788306|NCT04546373|Drug|Niraparib|Patient's medical records will be screened by local clinical staff to assess for eligibility according to selection criteria. The study comprises a single study visit, in which the patient will give her informed consent to participate (when the patient is alive) and the physician will extract the study data from the patient's medical charts. All eligible deceased and consenting living patients at the participating centers will be included. Data will be directly retrieved from hospital medical records and reported in the electronic Case Report Form (eCRF).
15788307|NCT04546360|Procedure|Esophagogasrtoduodendoscopy, spleen stiffness measurement and liver stiffness measurement.|Time frame between elastography measurement and esophagogastroduodendoscopy is within 2 weeks.
15788308|NCT04546347|Radiation|[14C]AZD9833 Solution for Infusion, (NMT 22.8 kBq/5mL)|Dose of [14C]AZD9833 Solution for Infusion
15788309|NCT04546347|Drug|AZD9833 film-coated tablet A Dose 1|Dose 1 AZD9833 film-coated tablet A Dose 1
15788310|NCT04546347|Drug|AZD9833 Oral Solution|AZD9833 Oral Solution
15788311|NCT04546347|Drug|AZD9833 film-coated tablet B Dose 1|AZD9833 film-coated tablet B Dose 1
15788312|NCT04546347|Drug|AZD9833 film-coated tablet A Dose 2|Dose 1 of AZD9833 film-coated tablet A Dose 2
15788313|NCT04546347|Drug|AZD9833 film-coated tablet B Dose 2|Dose 1 of film-coated tablet B Dose 2
15788314|NCT04546334|Drug|Medical treatment|routine medical treatment of post herpetic neuralgia as controls (Pregabalin, acyclovir, and paracetamol)
15788315|NCT04546334|Procedure|Real Erector Spinae block|Ultrasound guided Erector spinae plane block with injection of local anesthetic bupivacaine (2 - 2.5 mg/kg, with a maximum of 175 mg/dose)
15788316|NCT04546334|Procedure|Real Erector Spinae block with magnesium sulphate|Ultrasound guided Erector spinae plane block with injection of local anesthetic bupivacaine (2 - 2.5 mg/kg, with a maximum of 175 mg/dose with the addition of MgSO4 (equivalent to 100 mg))
15788317|NCT04546334|Procedure|Sham Erector Spinae block|Ultrasound guided Erector spinae plane block with injection ofnormal saline
15788318|NCT04546321|Other|serum L carnitine level measuring|The serum level of total L carnitine was measured for both HIE and TTN cases
15788319|NCT04546308|Other|Resistance exercise training|Eight weeks whole-body resistance exercise training (80%1 repetition maximal, 3 sessions per week) followed by a 4-week detraining intervention
15788320|NCT04546295|Other|Brushlink application|Brushlink application + Interproximal brush
15788321|NCT04546295|Other|Water-flosser|Water-flosser
15788322|NCT04546295|Other|Interproximal brush|Interproximal brush alone
15788328|NCT04546243|Radiation|radiotherapy group|patients received radiotherapy
15788329|NCT04546230|Procedure|Low-Thoracic Epidural Anesthesia|"Under aseptic conditions and local anesthesia, an epidural catheter will be inserted using the Prefix Epidural Anesthesia Tray with an 18 G Tuohy needle & a 20 G catheter at the T7-8 or T8-9 intervertebral space. The epidural catheter will be threaded leaving 3 cm within the epidural space and tapped in place.
~Using a mixed preparation of isobaric Bupivacaine 0.5% with Fentanyl 2 μg per ml volume, a bolus dose of 5-10 ml will then be given via the epidural catheter, followed by 5-10 ml/hr as a continuous infusion to be started 1 hour later & continued throughout the procedure."
15788330|NCT04546230|Procedure|General Anesthesia|General anaesthesia will be induced with intra-venous administration of Fentanyl (2 μg/kg), Propofol (2 mg/kg), Atracurium (0.5 mg/kg) and Lidocaine (1 mg/kg). After tracheal intubation, balanced anaesthesia will be maintained with isoflurane in oxygen & infusion of atracurium at a rate of 0.5 mg/kg/hr; and mechanical ventilation will be provided.
15788331|NCT04546217|Combination Product|Treadmill training + transfer package (TT+TP)|Participants will walk in different speeds, step over obstacles, and keep their balance during perturbations in the robotic treadmill. In combination with the gait training, participants will also receive a group of behavioral strategies (Transfer Package). Participants will sign the behavioral contract to achieve safety while engaging in activities, increase use of the paretic leg in daily activities, and increase coordination of both legs. A list of activities to be performed outside the clinical setting, the Home Skill Assignment, will be developed for each day of the week during the treatment period and given to the participants at the end of the session. The Home Practice after treatment aims to assure continued progress with LE use after the intervention program is completed. The LE-MAL Log will be administered in all sessions to assess quality of movement of the affected leg, level of assistance needed to perform daily activities, and level of confidence.
15788332|NCT04546217|Device|Treadmill training (TT)|Participants in this group will walk in different speeds, step over obstacles, and keep their balance during perturbations in the robotic treadmill. The treadmill training will be identical to the experimental group, but no element of the TP will be delivered.
15788333|NCT04546204|Other|vaginal delivery|normal vaginal spontaneous delivery
15788334|NCT04546178|Behavioral|Prolonged exposure (PE)+ therapy|The intervention will be adapted prolonged exposure (PE+), which is PE with the addition of emotion regulation and acceptance modules. Participants will receive 15 weekly 90-minute sessions of PE+; these appointments will be divided into five sets of three sessions: 1) psychoeducation about adversity and its effects, substance use and the interplay of both substance use and adversity with psychosis; 2) emotion regulation and acceptance strategies; 3) awareness of thoughts and work on changing thoughts about adversity and substance misuse, 4) imaginal and in vivo exposures, and 5) review of treatment and planning for termination and maintenance.
15788335|NCT04546178|Drug|Treatment as usual (TAU)|The intervention will be antipsychotics prescribed by clinicians working within the Nova Scotia Early Psychosis Program (NSEPP) as well as case management supplied by their primary nurse. Program participants will have access to educational programs about psychosis, skills/vocational training, as well as familial education and support.
15788336|NCT04546165|Procedure|manipulation plus exercise|HLVA manipulation was performed for 8 sessions (twice a week for four weeks) using a segment-specific technique for segmental dysfunctions of the upper cervical spine. . By bringing the cervical spine to light flexion and about 15-20º lateral flexion without any rotational motion, the middle finger of the manipulating hand provided deep contact, and an HVLA thrust was applied out of the rotational slack by applying a deep force from the dorsal to the ventral direction
15788337|NCT04546165|Procedure|suboccipital inhibition plus exercise|Suboccipital inhibition was performed for 8 sessions (twice a week for four weeks) as a combined muscle and soft tissue inhibition technique. While the patient was in the supine position, the physician sitting at the top end of the table placed the fingers of both hands on the patient's suboccipital region
15788338|NCT04546165|Procedure|exercise|Patients were asked to exercise at least three days a week during treatment. The exercise program, which lasted 20 to 30 minutes, included cervical range of motion (ROM) exercises to warm-up and cool-down, and then stretching exercises of cervical and upper thoracic spine muscles (trapezius, levator scapula, sternocleidomastoid) and strengthening exercises (cervical isometric contraction and concentric contraction of the deep cervical flexor muscles).
15788339|NCT04546152|Device|HYAPROF® SOFT and HYAPROF® BALANCE|Dermal filler injection to different facial areas
15788340|NCT04546139|Other|footwork|six-point footwork
15788341|NCT04546126|Drug|Dexamethasone (Group 2)|Participants will take 1 mg dexamethasone 2x a day for 3 days to suppress cortisol production.
15788342|NCT04546126|Drug|Cosyntropin (Group 3)|Cosyntropin, 250 micro-gm will be administered IV. Five minutes following administration FNP-59 will be given. Following uptake of FNP-59 imaging will occur.
15788343|NCT04546126|Combination Product|PET/CT Scan with FNP-59|FNP-59, a radiotracer, is administered for PET/CT scans.
15788344|NCT04546113|Procedure|Ultrasound-guided Bilateral Paravertebral Block performed with a 20 ml injection of ropivacapine 3,75 mg/ml/side|Bilateral injection of 20 ml of Ropivacaïne 3,75 mg/ml/side
15788345|NCT04546113|Procedure|Ultrasound-guided Bilateral Erector Spinae plane Block performed with a 20 ml injection ropivacaine 3,75 mg/ml/side|Bilateral injection of 20 ml of Ropivacaïne 3,75 mg/ml/side
15788346|NCT04546100|Other|Maternal-Infant Exercise Program|"Maternal-Infant Exercise Program can be divided into three videos stages. As time progresses during the three months, the parent-child exercise videos provided will have stronger intensity. The content includes general post-natal exercises (e.g., baby Lying on the mother's bed, raising legs or back of hands exercises, breast exercises; neck exercises; pelvic swinging exercises), aerobic exercises (e.g. walking with strollers, walking with baby on back), core exercises (e.g. kneeling balance, kneeling Push ups, stick exercises, modified side stick exercises) and hip and leg exercises (such as donkey kicks, side lifts), etc., with relaxing music during exercise."
15788348|NCT04546074|Drug|Pembrolizumab and Imatinib mesylate|"In Phase Ib study:
~Level 1: Imatinib mesylate 200mg QD + Pembrolizumab 200mg Q3W, Level 2: Imatinib mesylate 400mg QD + Pembrolizumab 200mg Q3W"
15788349|NCT04546074|Drug|Pembrolizumab and Imatinib mesylate|In Phase II study, eligible patients receive the dose determined in phase Ib cohort.
15788378|NCT04545840|Device|Dental Implants|Dental Implants will be used according to standard routine in daily practice, according to all indications as specified by the manufacturer in the IFU (informations for use).
15788350|NCT04546061|Behavioral|Project Uplift|Substance use and mental health treatment for young sexual and gender minorities in Durham and Charlotte, NC in conjunction with intensive wraparound services that address factors that influence substance use and mental health among this population.
15788351|NCT04546048|Behavioral|Strength Exercise Training|The 8-week exercise-training program consisted of two 30-min sessions a day for 5 days/week and conducted by elastic exercise bands in 2-3 sets, 6-10 repetitions, with 1-2 min rest between sets (M. Deltoideus and M. Quadriceps are trained as major muscle groups). The 8-repetition maximum(8RM) is used to determine training loads with the rated perceived exertion(RPE) lower than 5-7 on the Modified Borg scale(MBS). The program consisted functional exercises by half squat to squat and sit-to-stand chair exercises. Exercise sessions were supervised twice daily during the 1st week, the 2nd week training included one supervised and one unsupervised daily sessions. The remaining 6-week training program conducted at home individually after discharge. Patients instructed for the ongoing 8-week training program and a patient-specific schedule delivered to subjects. Phone calls are provided weekly and training load is assessed while generating 4th week evaluations.
15788352|NCT04546035|Device|radial Extracorporeal Shockwave Therapy|rESWT was given on hamstring muscles, with the subject lying on prone position. No anesthesia was required.
15788353|NCT04546022|Drug|Drug: G.S.P. Solution 400 mg/ml I.V. 1.25 ml/kg BW G.S.P. solution after fasting for 6 hours.|
15788360|NCT04545996|Other|Suboccipital Inhibition Technique|Suboccipital Inhibition Technique For 2min And Conventional Treatment Hot Pack For 10 To 15 Mints And Muscle Energy Technique(Post Facilitation Stretch) 5 Reps × 1 Set Sessions: 2 TIME A WEEK FOR 4 CONSECUTIVE WEEKS
15788361|NCT04545996|Other|Cranio Cervical Flexion Exercises.|Cranio cervical flexion exercises10 repetitions for 10 seconds and conventional treatment hot pack for 10 to 15 mints and muscle energy technique(post facilitation stretch) 5 reps × 1 set Sessions: 2 TIME A WEEK FOR 4 CONSECUTIVE WEEKS
15788362|NCT04545983|Other|Motion Analysis|Cinematographic recordings will be made. Participants are seated on a crutch, adjustable in height, with their neck, shoulders and head free. Before recordings are made, participants will be instructed to perform the prescribed flexion and extension movement in about 10 seconds with 7 frames per second. Participants are placed on the crutch with their shoulder's perpendicular to the image intensifier to obtain sagittal images from the occiput till C7. As soon as the recording is started, the participant is instructed to move his head in the sagittal plane from maximal extension to maximal flexion, without moving the upper part of the body. It is important that the participants shoulders are kept as low as possible while making the recordings to ensure that all the cervical vertebrae are visible. The movement of the cervical spine should be as fluent as possible to prevent for sudden large rotations and translations between consecutive frames.
15788363|NCT04545970|Combination Product|Facial cleanser|Facial cleanser to be used by study participants
15788364|NCT04545970|Combination Product|Facial moisturizer|Bland moisturizer to be used by study participants after serum in the evening.
15788365|NCT04545970|Combination Product|Sunscreen|Sunscreen to be applied after application of serum in the morning.
15788366|NCT04545957|Device|MRI Simulator|Radiation mapping to define the target for radiation.acquiring MR data at the specified timepoint in a patient's care plan and ability to identify the radiation target and develop a radiation therapy plan on the MR data.
15788367|NCT04545957|Radiation|Radiation Therapy|In Phase I, radiation will be institutional standard per disease site. In Phase II, either radiation according to MR-based dose painting or adjusted RT. These adjusted doses and/or RT will vary per disease site and will be pre-specified in the subprotocols.
15788368|NCT04545944|Drug|Vonoprazan|20 mg tablets administered orally
15788369|NCT04545944|Drug|Midazolam|2 mg syrup administered orally
15788370|NCT04545931|Device|Posterior tibial nerve stimulation|34-gauge stainless steel needle is inserted about three finger breadths cephalad to the medial malleolus. In children, previous administration of a topical anesthetic agent (e.g. lidocaine) can help to reduce pain and fear associated with needle insertion. The goal is to place the tip of the needle close to the PTN without actually touching it. The negative electrode is placed on the same leg near the arch of the foot. The needle and the electrode are connected to a low voltage (9 V) stimulator
15788371|NCT04545931|Drug|Desmopressin Acetate|0.2 mg, single evening dose ) for 12 weeks, tapering to half of the dose daily for two weeks before discontinuation
15788372|NCT04545918|Device|Follicle Clarity|Mask Region-based Convolutional Neural Network in Ultrasound Follicle Identification
15788373|NCT04545905|Diagnostic Test|ANC surveillance|Clinic-based testing of all pregnant women during antenatal care visits.
15788374|NCT04545892|Drug|Capsaicin|One milliliter of each dilution was pipetted on to 2 cm filter paper squares. Then, the filter papers were let dry. Immediately before application, they were rehydrated with 1 milliliter of distilled water
15788375|NCT04545879|Dietary Supplement|Raw garlic juice containing allicin|Fresh garlic juice containing around 48mg allicin for 7 days
15788376|NCT04545866|Drug|budesonide (Pulmicort nebulizing suspension).|The first dose of budesonide is 0.25 mg/kg in a volume of 1 ml/kg, for a total volume of 2.5 ml/kg of Curosurf + 1 ml/kg of budesonide. If the infant is to receive a second dose of study drug within 50 hours of birth, the dosage of Curosurf is 1.25 ml/kg for the second dose and 1 ml/kg of budesonide.
15788377|NCT04545866|Drug|surfactant (poractant alfa;Curosurf)|The first dose of surfactant (poractant alfa; Curosurf) is 2.5 ml/kg. If the infant is to receive a second dose of study drug within 50 hours of birth, the dosage of Curosurf is 1.25 ml/kg for the second dose.
15788379|NCT04545814|Device|Stereotactic Radiosurgery|Maximum Tumor Diameter ≤ 2 cm = 20-24 Gy; Maximum Tumor Diameter 2.1-3.0 cm = 18 Gy; Maximum Tumor Diameter 3.1-5.0 cm = 15 Gy
15788380|NCT04545801|Drug|0.25 mg/kg of Ketamine|patients will recieve 0.25mg/kg of ketamine intravenously 5 min after spinal anesthesia
15788381|NCT04545801|Drug|20ml of normal saline solution|20ml of normal saline solution intravenously 5 minutes after spinal anesthesia
15788382|NCT04545788|Drug|Total oral short-term therapy that includes linezolid, bedaquiline and/or cycloserine.|AM is the traditional anti-TB drugs. Linezolid, bedaquiline and/or cycloserine, that might have potential efficacy of replacing injectable anti-TB drugs, are included into the total oral short-term therapy, and replace AM.
15788383|NCT04545762|Drug|Fludarabine|Given intravenously (IV)
15788384|NCT04545762|Drug|Cyclophosphamide|Given intravenously (IV)
15788385|NCT04545762|Biological|anti-CD19 CAR-T cells|Single infusion
15788386|NCT04545749|Biological|UB-612|UB-612 is a proprietary high-precision designer S1-RBD-protein based vaccine incorporating a Th/CTL epitope peptide pool which could bind to human MHC-I and MHC-II to activate T cells.
15788387|NCT04545736|Drug|Metformin hydrochloride|Metformin is commercially produced in immediate and extended release. Participants will receive an immediate release formulation of metformin of 500mg daily at study entry. This dose will be titrated up weekly in 500mg increments to reach a goal of 2000mg daily maximum. Once participants >=17 years of age reach 2000mg metformin immediate release they will switch to an extended-release formulation (1000mg twice a day by mouth). Participants >= 17 years of age that cannot tolerate 2000mg will be permitted to reduce their daily dose to a minimum of 1000mg/day. Because metformin extended release is not FDA-approved for children under the age of 17, participants under 17 will remain on the immediate release formulation. For these participants who remain on standard formulation, the maximum tolerated dose between 1000mg and 2000mg/day will be given.
15788388|NCT04545723|Device|FibriCheck|FibriCheck is a smartphone application that measures hearth rhythm using the phone's built-in camera. It is able to detect aberrant rhythms, such as atrial fibrillation.
15788389|NCT04545710|Drug|Abemaciclib|Abemaciclib 150mg BID
15788390|NCT04545710|Drug|Osimertinib|Osimertinib 80mg daily
15788391|NCT04545697|Other|Medcorder|Medcorder is a smartphone app that is HIPAA compliant for the use of on patient recordings of consults with healthcare providers.
15788392|NCT04545684|Behavioral|Motor imagery|The person will have to imagine different scenarios of manual gripping
15788393|NCT04545684|Behavioral|Placebo intervention|The placebo group will imagine a place without the presence of humans.
15788394|NCT04545671|Other|trifocal lens|not applicable as patients are already implanted with the trifocal lens
15788395|NCT04545645|Behavioral|median nerve mobilization|The patient is placed in a supine position and his cervical spine with 25º of lateral flexion on the opposite side of the member in which we perform the test. First a passive scapular depression is performed, 90º of shoulder abduction combining external shoulder rotation. Next, a supination of the forearm is performed with wrist extension and finger extension. Finally, the elbow is extended to the limit of resistance or when the investigator observes the elevation of the shoulder girdle.
15788396|NCT04545645|Behavioral|Neural stress provocation with cognitive auditory distraction|Neural provocation of the median nerve is performed but an auditory distraction is added with a metronome with a constant time of 50 beats per minute.
15788397|NCT04545645|Behavioral|Providing neural stress with a motor distraction|The neural provocation of the median nerve is performed and we add a motor distraction that consists of the patient intermittently squeezing a ball with the opposite hand.
15788398|NCT04545645|Behavioral|Neural stress provocation with auditory and motor cognitive distraction.|The neural provocation of the median nerve is performed, we add auditory distraction with the metronome with a constant time of 50 BPM and a motor distraction consisting of squeezing a ball to the rhythm that sounds the metronome.
15788399|NCT04545619|Device|QDOT MICRO System|QDOT Micro Catheter with nGEN Generator
15788400|NCT04545606|Behavioral|In-Person CBT for insomnia in children with autism|"7 modules administered in-person
~Sleep Hygiene & Sleep Prescription
~Bedtime Routine & Parent Management
~Cue Control & Parent Management
~Co-Sleeping & Parents Fading out of Room
~Circadian Education, Morning Routine, & Relaxation
~Cognitive Therapy Basics
~Nighttime Fears, Anxiety, & Nightmares"
15788401|NCT04545606|Behavioral|Remote CBT for insomnia in children with autism|"7 modules administered over telehealth/videoconferencing
~Sleep Hygiene & Sleep Prescription
~Bedtime Routine & Parent Management
~Cue Control & Parent Management
~Co-Sleeping & Parents Fading out of Room
~Circadian Education, Morning Routine, & Relaxation
~Cognitive Therapy Basics
~Nighttime Fears, Anxiety, & Nightmares"
15788402|NCT04545606|Behavioral|Remote sleep hygiene and related education (SHARE) for insomnia in children with autism|"7 modules administered over telehealth/videoconferencing
~Sleep Education
~Sleep Architecture & Parasomnias
~Physical Activity & Sleep
~Nutrition, My Plate, & Breathing during Sleep
~Stress, Sleep, Dreams, & Nightmares Connections
~Mood, Self-Esteem, & Sleep
~Light & Dark Cycle"
15788403|NCT04545593|Behavioral|Positive Minds Strong Bodies Enhanced|The Positive Minds Strong Bodies Enhanced intervention (PMSB-E) was designed to provide a single, integrated program that could address the dual challenges of mental health and disability among minority elders. PMSB-E seeks to improve mood symptoms, identify and correct negative distortions or cognitions, promote behavioral activation through engaging the participant in pleasant activities, and encourage developing supportive relationships. All sessions are tailored to the participant's needs using a collaborative approach.
15788404|NCT04545593|Behavioral|Enhanced Usual Care|Participants in this arm will receive a booklet about anxiety and depression in Spanish, English, or Mandarin/Cantonese. Research staff will call the participant 4 times over the course of 6 months to administer mental health items, a suicide questionnaire, and a question about medication side effects to mimic the administration schedule in the intervention group.
15788407|NCT04545567|Device|RocketAP|Artificial pancreas system which is designed to be able to identify when you have eaten and provide insulin for this meal
15788408|NCT04545567|Device|USS Virginia|Artificial pancreas system which responds to glucose fluctuations by modulating insulin delivery but does not specifically detect meal ingestion
15788411|NCT04545554|Dietary Supplement|Vitamin D|All participants will receive daily supplementation with vitamin D.
15788412|NCT04545541|Drug|Nebulised unfractionated heparin (UFH)|Nebulised UFH (25,000 Units in 5 mL) will be administered 6-hourly via an Aerogen Solo vibrating mesh nebuliser while patients receive invasive mechanical ventilation in ICU and for a maximum of 10 days.
15788413|NCT04545528|Behavioral|Dietary recommendations|The test group will be seen by a nutritionist and will receive specific dietary recommendations according to their specific comorbidities and drugs
15788414|NCT04545515|Drug|ELX/TEZ/IVA|Fixed dose combination (FDC) tablet for oral administration.
15788415|NCT04545515|Drug|IVA|Tablet for oral administration.
15788416|NCT04545502|Device|Gelsoft Plus Vascular Graft|Gelatin coated, knitted vascular prosthesis implanted to act as a conduit for channeling blood during repair of damaged or diseased vessels.
15788417|NCT04545502|Device|Vascular Bypass Graft|Gelatin coated, knitted vascular prosthesis implanted to act as an extra-anatomical bypass for channeling blood during repair of damaged or diseased vessels.
15788418|NCT04545502|Device|Cardiovascular Patch|Cardiovascular knitted polyester patches are frequently used to treat the carotid or femoral arteries to prevent stroke and repair damage to vessels.
15788419|NCT04545502|Device|Gelweave Vascular Graft|The Gelweave woven polyester vascular graft allows replacement of large sections of arteries and, following anastomosis to the native blood vessel, provides a stable conduit for blood flow.
15788420|NCT04545502|Device|Gelweave Valsalva Vascular Graft|This woven polyester graft is designed to match the aortic root anatomy and is implanted to repair or replace a portion of the aorta in case of an aneurysm, dissection or coarctation at the level of the thoracic aorta.
15788421|NCT04545489|Behavioral|Nurse-led intervention group|This is a nurse-led intervention for 12 months which focuses on behavioral and medication management.
15788422|NCT04545489|Behavioral|Education control group|This group will receive education materials related to CVD risk reduction at each 4 month visit over the course of 12 months.
15788423|NCT04545476|Device|Participants in this group will receive the experimental APIS Biomaterial on the Head.|One layer of APIS® will be applied to the post-operative wound on the head covered by petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.
15788424|NCT04545476|Device|Participants in this group will receive the experimental APIS Biomaterial on the Lower Extremities.|One layer of APIS® will be applied to the post-operative wound on the lower extremities covered by petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.
15788425|NCT04545476|Other|Standard Secondary Intention Healing on the Head|Participants in this group will receive standard secondary intention wound healing post-operative care on the Head. Post-operative wound will heal via conventional secondary intention. Application of petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.
15788426|NCT04545476|Other|Standard Secondary Intention Healing on the Lower Extremities|Participants in this group will receive standard secondary intention wound healing post-operative care on the Lower Extremities. Post-operative wound will heal via conventional secondary intention. Application of petrolatum impregnated gauze, a non-stick Telfa pad, gauze, and Opsite tape.
15788427|NCT04545463|Dietary Supplement|FIBRACEP|A total intake of 7 g/day of FIBRACEP (provided in 6 cookies of 15 g/each) during two months
15788428|NCT04545463|Dietary Supplement|INSOLUBLE|A total intake of 7 g/day of wheat bran (provided in 6 cookies of 15 g/each) during two months
15788429|NCT04545463|Dietary Supplement|SOLUBLE|A total intake of 7 g/day of psyllium plantago (provided in 6 cookies of 15g/each) during two months
15788430|NCT04545450|Drug|dutasteride 5 mg/day|Administration of a placebo pill or dutasteride 5 mg pill daily in addition to intramuscolar testosterone undecanoate
15788431|NCT04545450|Drug|Testosterone Undecanoate|Administration of a placebo pill or dutasteride 5 mg pill daily in addition to intramuscolar testosterone undecanoate
15788432|NCT04545437|Other|Admission to ICU|Exposure is admission to an Intensive Care Unit
15788433|NCT04545424|Device|Hypothermia|Subjects will be cooled using either cooling blankets or gel-pad systems to maintain core temperature 34-35°C.
15788434|NCT04545424|Drug|Neuromuscular Blocking Agents|Subjects in the TH + NMB arm will be deeply sedated using agents at the discretion of the primary ICU team, then start continuous iv infusion of either cisatracurium, atracurium, or vecuronium titrated to 2 twitches on train of four monitoring and further titrated to ablate visible shivering.
15788435|NCT04545424|Device|Standard of care|Subjects who are hypothermic (≤36°C) during CRRT will receive surface warming to restore core temperature to 37°C. Patients with core temperature >38°C will receive 650 mg acetaminophen and, if temperature remains >38°C, surface cooling will be initiated to return core temperature to 37-38°C.
15788436|NCT04545411|Drug|Dapagliflozin 10 MG [Farxiga]|4-Week, double-blind, once daily oral 10mg dapagliflozin
15788437|NCT04545411|Drug|REMD-477|4-Week, double-blind, once weekly subcutaneous injection with 35mg REMD-477 in 1mL solution.
15788438|NCT04545411|Drug|Placebo|4-Week, double-blind, once weekly subcutaneous injection with placebo in 1mL solution.
15788439|NCT04545398|Other|Food. Beef, Pasture-raised|Pasture-raised beef
15788440|NCT04545398|Other|Food. Beef, Grain-fed|Grain-fed beef
15788441|NCT04545398|Other|Food. Meat alternative|Meat alternative
15788442|NCT04545398|Other|Food, Lamb|Lamb
15788445|NCT04545372|Other|aerobic exercise|
15788446|NCT04545359|Behavioral|Alpha-based neurofeedback|"Twelve 21-minute sessions (minimum of 1 session and maximum of 3 sessions per week) of auditory alpha-based neurofeedback with the Melomind device developed by myBrain Technologies (France). Recording of felt relaxation, perceived stress level, anxiety level pre-post sessions.
~Electrophysiological: Recording of EEG signals on 32 electrodes every two sessions."
15788447|NCT04545359|Behavioral|Sham neurofeedback|"Twelve 21-minute sessions (minimum of 1 session and maximum of 3 sessions per week) of an auditory sham neurofeedback with the Melomind device developed by myBrain Technologies (France). Sham feedback is based on the real feedback of the participants in the Experimental arm. Recording of felt relaxation, perceived stress level, anxiety level pre-post sessions.
~Electrophysiological: Recording of EEG signals on 32 electrodes every two sessions."
15788481|NCT04544995|Drug|Niraparib|Niraparib will be administered
15788482|NCT04544995|Drug|Dostarlimab|Dostarlimab will be administered.
15788448|NCT04545346|Other|Low Glutamate diet|Participants will be given extensive online dietary training and assigned to follow the low glutamate diet for one month. The low glutamate diet reduces the consumption of free glutamate, while optimizing dietary micronutrient and antioxidant intake.
15788449|NCT04545333|Diagnostic Test|clonoSEQ Assay|minimal residual disease (MRD) assay using blood, bone marrow, or other tissue containing tumor cells
15788450|NCT04545320|Behavioral|Usual care control group|Health education
15788451|NCT04545320|Behavioral|HIIT group|Once-a-week HIIT
15788452|NCT04545320|Behavioral|MICT group|Once-a-week MICT
15788453|NCT04545307|Biological|Allogenic transplant of BM-MSC in a root canal from patients with immature apexes and pulpar necrosis and apical periodontitis|The implant of BM-MSC/MSC-Endo/PRP in a clean and shaped root canal from patients with immature apexes and pulpal necroses and apical periodontitis
15788454|NCT04545294|Device|Theta tACS|See detail in arm/group descriptions regarding the intervention.
15788455|NCT04545268|Device|Neuromuscular electrical stimulation (NMES)|"NMES will carried out with four-channel myostimulator Beurer EM80 (Germany). Self-adhesive electrodes locates above the quadriceps, the duration of the NMES session was 60 minutes, including 5-minute periods of heating and hitch. Throughout the series, rectangular pulses with a frequency of 45 Hz will modulate. As a result, tonic contraction of these muscles will induce for 12 seconds, followed by a pause of 5 seconds. The amplitude of electrical exposure will select separately for each of the four channels until good muscle contraction (visually or by palpation) without pain. Electrical stimulation will start from the second day after the admission to preoperative department and will carried out during the entire preoperative period (about 10 days)."
15788456|NCT04545268|Device|Transcutaneous electrical stimulation|For the Sham group, electrodes will follow the same site, but the stimulation will only increase to an intermittent tingling sensation with the machine setting on TENS instead of NMES which is not enough to make noticeable changes in muscle mass or circulation. Intensity settings will not change over time.
15788457|NCT04545255|Device|Shockwave treatment|ED 1000 shockwave generator
15788458|NCT04545242|Drug|Dexamethasone|Intravenous dexamethasone (low vs. moderate doses) during 10 days
15788459|NCT04545229|Other|VR-based Pain Alleviation Tool (VR-PAT)|Four smart phone based virtual reality games developed by the Research Information Solutions and Innovation (RISI) at the Nationwide Children's Hospital.
15788460|NCT04545216|Other|Long-distance mountain running|Impact of a mountain race on the knee cartilage
15788461|NCT04545203|Other|Slow-stroke back massage|Slow-stroke back massage was performed to the breast cancer patients in intervention group. The SSBM sessions were administered 10 minutes before and after chemotherapy treatment.The SSBM was applied for 20 minutes in total, on each cycle. The intervention group received 20-minute SSBM sessions 3 chemotherapy cycle in addition to the routine care.
15788462|NCT04545190|Dietary Supplement|Glucose|To investigate the effects of glucose intake during resistance training on muscle biological adaptations
15788463|NCT04545177|Device|NICO Myriad and Tissue Preservation System (TPS)|Tumor tissue will be obtained by the NICO Myriad and Tissue Preservation System (TPS) via an automated, standardized methodology
15788464|NCT04545164|Diagnostic Test|CAD4TB|CAD4TB is a Computer Aided Diagnosis (CAD) image processing algorithm that can aid interpretation of Chest X-ray images to accurately detect tuberculosis.
15788465|NCT04545164|Diagnostic Test|FujiLAM|Fujifilm SILVAMP TB LAM is a high sensitivity test for mycobacterial lipoarabinomannan (LAM) in urine samples.
15788466|NCT04545151|Drug|Verapamil SR|"Study drug will be provided in blisters and packaged and labelled. Each package will be labeled as required per country requirement. Labels will be blinded.
~Drug adminstration:
~from Day 0 to Week 4: 120 mg once daily
~from Week 4 to Week 8: 240 mg once daily
~from Week 8 to Month 12: 360 mg once daily"
15788467|NCT04545151|Drug|Placebo|"Placebo will be provided in blisters and packaged and labelled. Each package will be labeled as required per country requirement. Labels will be blinded.
~Drug adminstration:
~from Day 0 to Week 4: 120 mg once daily
~from Week 4 to Week 8: 240 mg once daily
~from Week 8 to Month 12: 360 mg once daily"
15788468|NCT04545138|Other|cognitive training combine treadmill training|Treadmill training includes warming up for 3 minutes, training for 25 minutes, and relaxing for 2 minutes. The speed of the treadmill during the warm-up and relaxation period is based on the participant's Borg's rating of perceived exertion (RPE) 7-9 points (very slight to very slight), and the RPE during the training period does not exceed 10~12 points (slight), and ensures that patients can be cognitively trained at the same time. The cognitive training tasks will be projected on the screen and the participant have to answer the task orders during treadmill training simultaneously.
15788469|NCT04545138|Other|Treadmill training|Treadmill training includes warming up for 3 minutes, training for 25 minutes, and relaxing for 2 minutes. The speed of the treadmill during the warm-up and relaxation period is based on the participant's Borg's rating of perceived exertion (RPE) 7-9 points (very slight to very slight), and the RPE during the training period does not exceed 10~12 points (slight).
15788470|NCT04545112|Device|CABG|Elective, on-pump coronary artery bypass (CABG) surgery. Each study subject will receive an internal mammary artery (IMA) conduit to the left anterior descending (LAD) coronary artery, one saphenous vein graft and one XABG medical device.
15788471|NCT04545099|Drug|Sugammadex|Administration of Sugammadex for muscle relaxation reversal
15788472|NCT04545099|Drug|Neostigmine|Administration of Neostigmine for muscle relaxation reversal
15788473|NCT04545086|Behavioral|Video Based Education, Music Therapy|Video Based Education and Music Therapy was given as a part of Interventions to relieve anxiety of patients undergoing Magnetic Resonance Imaging
15788474|NCT04545073|Device|PanOptix|Trifocal IOL with ORA in post refractive patients
15788475|NCT04545060|Biological|VIR-7831|VIR-7831 given by intravenous infusion
15788476|NCT04545060|Drug|Placebo|Sterile normal saline (0.9% NaCl) given by intravenous infusion
15788477|NCT04545047|Biological|COVID-19 convalescent plasma|Convalescent plasma collected from individuals who have recovered from COVID-19
15788478|NCT04545034|Other|water aerobic exercise|The EP would be formed by continuous session of dynamic water aerobic exercise which consisted of a dynamic warm-up period (5 minutes), an active exercise period at the established intensity of HR (35 minutes), and a cooldown period (5 minutes) to total 45 minutes, with a intensity of 75%HR.
15788479|NCT04545008|Drug|Famotidine|Oral Famotidine
15788480|NCT04545008|Drug|N-Acetyl cysteine|Oral N-Acetyl Cysteine
15788483|NCT04544982|Other|Blue fenugreek kale extract|One capsule to be taken orally before breakfast and one capsule after lunch, with water.
15788484|NCT04544982|Other|Placebo|One capsule to be taken orally before breakfast and one capsule after lunch, with water.
15788485|NCT04544969|Drug|cisplatin-based chemotherapy|"GP: cisplatin 80 mg/m2 intravenous infusion on day1, gemcitabine 1000 mg/m2 intravenous infusion on day 1 and 8, both drugs are given every 3 weeks, recommended 6 cycles.
~TP: cisplatin 75 mg/m2 intravenous infusion in day1, docetaxel 75 mg/m2 intravenous infusion in day 1, both drugs are given every 3 weeks, recommended 6 cycles.
~PF: cisplatin 100 mg/m2 intravenous infusion in day1, fluorouracil 4000 mg/m2 intravenous infusion in day 1 to 5, both drugs are given every 3 weeks, recommended 6 cycles.
~TPF: cisplatin 60 mg/m2 intravenous infusion in day1, docetaxel 60 mg/m2 intravenous infusion in day 1, fluorouracil 3000 mg/m2 intravenous infusion in day 1 to 5, both drugs are given every 3 weeks, recommended 6 cycles.
~Choice of chemotherapy regimen is decided by patient's doctor in charge."
15788486|NCT04544956|Drug|GSK3228836|GSK3228836 will be available as a clear colorless to slightly yellow solution for injection in 150 mg/milliliters (mL) vial to be administered SC once weekly.
15788487|NCT04544956|Drug|Nucleos(t)ide therapy|Participants receiving nucleos(t)ide therapy upon entry in the study will continue to receive nucleos(t)ide therapy for the duration of the study.
15788488|NCT04544943|Drug|BioLexa- Cohort 1|Twice daily application of topical BioLexa™ lotion, administered for 14 days in adult healthy subjects
15788489|NCT04544943|Drug|BioLexa- Cohort 2|Twice daily application of topical BioLexa™ lotion, administered for 14 days in adult mild to moderate AD patients
15788490|NCT04544943|Drug|Placebo|Twice daily (BID) application of placebo for 14 days
15788491|NCT04544943|Drug|Gentamicin|Twice daily (BID) application of Gentamicin for 14 days
15788492|NCT04544930|Behavioral|therapist-guided|Therapist-guided Internet treatment comprises eight text modules on the Internet that include psychoeducation, tasks and exercises. Key elements are setting goals for treatment, identifying and challenging negative automatic thoughts through a number of exercises and behavioral experiments, as well as making a plan for relapse prevention. Therapist guidance is secondary to the self-help modules, and the therapist provides feedback to the patient online in the secured program once a week
15788493|NCT04544917|Behavioral|SmartManage for HIV+ cancer survivors|Ten weekly therapist delivered group sessions delivered via web conference. Sessions focus on cognitive behavioral stress management, psychoeducation, and management strategies for dual diagnosis of HIV and cancer. Participants will have access to the SmartManage web platform which has all intervention material, resources, and exercises.
15788494|NCT04544917|Behavioral|Educational Control|Participants in the control condition will view ten videos over ten weeks, consisting of informational and educational material relevant to cancer and HIV.
15788495|NCT04544904|Device|PAARx|Prescription Physical Activity Programming Application
15788496|NCT04544904|Device|JM|Joint Management (JM) web-based joint management resource.
15788497|NCT04544891|Other|blood sampling|Blood will be collected every 3 days until Day 28, discharge, or death
15788498|NCT04544865|Device|Staple Line Reinforcement|ENDOPATH ECHELON Staple Line Reinforcement is used for reinforcement of staple lines during lung resection and bariatric surgical procedures, according to instructions for use.
15788499|NCT04544852|Behavioral|Current practice|"Intervention A depicts current practices by informing the participants that FIT kits can be obtained from from the Singapore Cancer Society (SCS) or one of their collection point free of charge. Participants will be contacted at 3 months after enrollment to determine whether they have completed the FIT test."
15788500|NCT04544852|Behavioral|Targeted intervention programme|The targeted intervention programme includes participants undergoing a structured educational program regarding colorectal cancer and the importance of screening in its prevention. The details will be explained to them using the pamphlet from MOH on Colorectal Cancer Screening. They will also be offered two FIT kits free of charge. Research team will educate participants on how to perform the FIT test. A detailed information guide on how to collect stool samples for FIT kit and how to return the completed FIT kit to the NUH Colorectal Centre will be given to them. Participants will be contacted at 3 months after enrollment to determine whether they have completed the FIT test.
15788501|NCT04544839|Device|ADLC attachment system with PEEK inserts|"Each patient will receive 2 implants in the canine region using a guided-surgery protocol and a pre-prepared surgical stent. A healing abutment of an adequate size will be placed on the implant for transmucosal healing. The flaps will be subsequently sutured around the healing abutments. Patients' existing prostheses will be adjusted. Suture removal will be performed one week post implant placement.
~Three months later, implant level impressions will be made using the open tray technique. Each patient will be then be randomized using eCRF (electronic Case Report Form) to either ADLC group or LOC group. A final cast of the patients will be obtained and the attachments will be installed using an in-direct technique by a calibrated prosthodontists."
15788502|NCT04544826|Drug|JNJ-77474462|JNJ-77474462 will be administered as SC injection.
15788503|NCT04544826|Drug|Placebo|Matching placebo to JNJ-77474462 will be administered as SC injection.
15788504|NCT04544813|Drug|JNJ-77474462|Participants will receive JNJ-77474462 as a liquid formulation in Cohort A, B, C, D, F and G (SC injection) and in Cohort E, H and I (IV infusion).
15788505|NCT04544813|Drug|Anakinra|Participants will receive a SC injection of anakinra 100 mg once daily for 3 days.
15788506|NCT04544800|Device|Use of Splint for UADT Visualization|The use of a splint to assist the patient and the surgeon with UADT procedures.
15788507|NCT04544787|Biological|Novel OPV2 candidate 1|"Live-attenuated serotype-2 poliovirus derived from a modified Sabin type-2 infectious cDNA clone and propagated in Vero cells; candidate 1 (S2/cre5/S15domV/rec1/hifi3).
~Modifications included the following:
~Changes to the viral nucleotide sequence in part of the 5'-untranslated region to improve the genetic stability of this major attenuating determinant of Sabin type-2 to avoid reversion by single nucleotide changes.
~Two modifications in the polymerase 3D to further improve stability of the attenuation and reduce frequency of recombination events
~Relocation of a key replication element from the 2C coding region to the 5'-untranslated region, to inhibit recombination."
15788531|NCT04544553|Other|No SMS reminder|The group did not receives any SMS regarding scheduled appoinments.
15788532|NCT04544540|Other|Units of transfusion|Participants will either receive 1-unit or 2-unit red blood cell outpatient transfusions
15789109|NCT04540107|Procedure|Magnetic Resonance Imaging|Undergo MRI
15788508|NCT04544787|Biological|Novel OPV2 candidate 2|"Live-attenuated serotype-2 poliovirus derived from a modified Sabin type-2 infectious cDNA clone and propagated in Vero cells; candidate 2 (S2/S15domV/CpG40).
~Modifications included the following:
~Changes to the viral nucleotide sequence in part of the 5'-untranslated region to improve the genetic stability of this major attenuating determinant of Sabin type-2 to avoid reversion by single nucleotide changes.
~silent non-coding modifications engineered within the capsid (VP1-4) designed to reduce replicative fitness and, potentially, to improve stability of the attenuated phenotype while also reducing transmission."
15788509|NCT04544787|Biological|Placebo|sugar syrup, propylene glycol (Sirupus simplex, Propylenglycolum, European Pharmacopoeia)
15788510|NCT04544774|Drug|AIT|AIT for airborn allergens (SCIT/SLIT)
15788511|NCT04544774|Diagnostic Test|NAPT|NAPT test with airborn allergens ( HDM, Threes, Grasses)
15788512|NCT04544761|Other|Structured Interview|Structured interview with research staff about your experience living with spinal cord injury
15788513|NCT04544748|Biological|GNR-051|Anti-PD1 monoclonal antibody
15788514|NCT04544735|Behavioral|Integrated Physical Therapy and Coping Skills Training|The proposed intervention will provide pelvic health physical therapy interventions including: education about vaginal moisturizers and lubricants, low back and hip assessment and instruction in accommodations (e.g., strategies for accommodating sexual position of choice), instruction in vulvar massage, instruction and facilitation of vaginal dilator use, and pelvic floor muscle training (PFMT) and exercises. Women will be given a set of vaginal dilators. Cognitive behavioral techniques that have been successfully used by physical therapists in prior intervention studies will be integrated into the PT intervention including breathing and relaxation techniques, guided imagery, systematic desensitization, cognitive restructuring techniques and coping thoughts, and problem solving
15788515|NCT04544722|Behavioral|Jianfei Kangfu Cao|The original treatment and Jianfei Kangfu Cao, once a day, 30 minutes each time.
15788516|NCT04544722|Behavioral|lung rehabilitation training|The original treatment and the lung rehabilitation training, once a day, 30 minutes each time.
15788517|NCT04544709|Drug|Low back intradiscal injection of platelet rich plasma (PRP)|SOC Intradiscal Lumbar PRP Procedure : A small amount of blood is drawn from you, then it is spun in a centrifuge to obtain only the platelets and few other cells. After being spun the small amount of platelets will be injected into the specific disc that is believed to be causing pain in an attempt to help reduce inflammation and pain at the site. The injection will be done under fluoroscopic guidance (x-ray) that allows very careful and precise placement of the needle.
15788518|NCT04544683|Drug|Cervical Transforaminal Epidural Injection with dexamethasone sodium phosphate|Transforaminal epidural steroid injection: Injection of 1 to 2 mL of 1% lidocaine to the skin and subcutaneous tissues, a 25-gauge spinal needle will be placed at the level and side of radicular pathology, based on clinical correlation of symptoms/signs and magnetic resonance imaging findings. Advancement to the appropriate target position in the neuroforamen will be performed under fluoroscopic guidance. Satisfactory target position achieved and confirmed in both anterior-posterior and oblique views, 0.5 to 1 mL of contrast will be injected under live fluoroscopic observation with or without digital subtraction angiography depending on suggestion of vascular uptake. Upon confirmation of a satisfactory epidural contrast pattern without vascular uptake, the injectate will be delivered: dexamethasone sodium phosphate 1mL (10mg/mL) and 0.5 ml of 1% preservative-free lidocaine (total volume 1.5 mL).
15788519|NCT04544657|Other|no intervention|No intervention for enrolled patients
15788520|NCT04544644|Drug|AK104+anlotinib|AK 104 is given by intravenous infusion and anlotinib is given by oral.
15788521|NCT04544631|Other|Virtual reality game as adjunctive pain management tool|A smart phone virtual reality-based pain alleviation tool (VR-PAT).
15788522|NCT04544618|Device|Virtual reality operating room simulation|The virtual reality simulation will begin with the participant sitting on a hospital bed wearing the virtual reality headset and holding the controllers. Participants will be oriented to the environment and provided with an explanation of how to navigate through the simulation (for approximately 2 minutes). Next, participants will explore the virtual operating room for a minimum of 5 minutes, or longer if desired. Following the exploration period, the scripted portion of the simulation will be begin. Here, participants will be taken through the mock anesthetic induction process (the virtual anesthetist will speak to the patient and walk them through the steps and the virtual nurse will assist). The simulation ends after the virtual oxygen mask is placed over the participant's mouth and the screen darkens.
15788523|NCT04544618|Device|Non-surgery-related virtual reality simulation|Participants will explore a non-surgery-related virtual reality simulation (e.g., Google Earth simulation) pre-programmed to the virtual reality headset.
15788524|NCT04544605|Other|Individualized-Chinese herbal medicine|"I. Lung and spleen qi deficiency syndrome Clinical manifestations: shortness of breath, fatigue, fatigue, anorexia, nausea, fullness, weak stool, and uneasiness. The tongue is pale and greasy. Recommended prescription: French Pinellia 9g, Chenpi 10g, Codonopsis 15g, Sunburn Astragalus 30g, Stir-fried Atractylodes 10g, Poria 15g, Huoxiang 10g, Amomum villosum 6g (later), and Licorice 6g
~II. Qi and Yin deficiency syndrome Clinical manifestations: fatigue, shortness of breath, dry mouth, thirst, palpitations, sweating, poor appetite, low or no lever, dry cough and little sputum; dry tongue, fine or weak pulses. Recommended prescription: North and south radix salviae 10g, 15g ophiopogonis, 6g American ginseng, 6g schisandra, 6g gypsum l5g, 10g light bamboo leaves, 10g mulberry leaves, 15g reed root, 15g salviae miltiorrhiza, 6g raw liquorice."
15788525|NCT04544592|Drug|CD19CAR-CD3Zeta-4-1BB-Expressing Autologous T-Lymphocyte Cells|The CD19 CAR used in this study consists of three main components: the variable regions of the anti-CD19 monoclonal antibody FMC63 71, linked to the TNFRSF19-derived transmembrane domain, the 4-1BB costimulatory molecule, and the signaling domain of the CD3-zeta molecule. The DNA encoding this receptor was cloned into a lentiviral vector (LV) backbone.
15788526|NCT04544579|Device|Stent grafts anchored in different areas|Endovascular repair of ascending aortic dissection patients with stent grafts anchored in different areas
15788527|NCT04544566|Device|Test product A|one new adhesive material which is applied to the baseplate and the subjects peristomal skin
15788528|NCT04544566|Device|Test product B|one new adhesive material which is applied to the baseplate and the subjects peristomal skin
15788529|NCT04544566|Device|Comparator|Already CE- marked product as a comparator which is applied to the baseplate and the subjects peristomal skin
15788530|NCT04544553|Other|SMS reminder|The group receives reminder for the follow-up at 1 week and 2 days prior to their scheduled appointments.
15788533|NCT04544514|Diagnostic Test|lung ultrasound|LUS was performed within first 20 to 30 minutes and repeated at 1, 2, 4 and 6 hours.
15788534|NCT04544501|Behavioral|Culturally-Targeted Video|"Culturally targeted narrative video: Is My Cancer Hereditary? Rosa Visits a Genetic Counselor. With R03 funding (R03CA191543) we developed a culturally targeted narrative video for at-risk Latinas. A multidisciplinary team of researchers collaborated with filmmakers to develop the script and video. The script was informed by health behavior conceptual models, evidence-based risk communication strategies, and formative research (40 interviews with providers and at-risk Latinas). The script addressed identified knowledge gaps (e.g., incorrect belief that pap smears screen for ovarian cancer), facilitators (e.g., inform family cancer risk), barriers (e.g., emotional concerns), and cultural factors (e.g., respect). The 18-minute video illustrates the GCRA process with the story of Rosa, a Latina cancer survivor at increased risk of HBOC. Rosa learns about HBOC risk factors, overcomes barriers, and attends genetic counseling."
15788535|NCT04544501|Other|FORCE Fact Sheet|A publically available Spanish-language fact sheet about HBOC and GCRA developed by FORCE.
15788536|NCT04544488|Procedure|Recording of expulsive efforts by connection of a pressure sensor to the women's bladder probe|"Using a pressure probe connected to a Foley Catheter, intra bladder pressure wille be registered during the whole duration of expulsive phase.
~The device will be inserted into women's bladder using usual guidelines for insertion of Foley catheter"
15788537|NCT04544475|Device|Revaree|Hyaluronic Acid Vaginal Insert (Revaree). A 2g vaginal insert that contains 5mg of HLA sodium salt and a base of semi-synthetic glycerides. It is an insert that does not require an applicator and should be placed in the vagina while laying down twice weekly.
15788538|NCT04544475|Drug|Estrace|Vaginal estrogen cream, estradiol: 100mcg
15788539|NCT04544462|Other|M2 Test|DNA will be extracted from saliva samples obtained from participants. Genetic testing will be performed to screen for the M2 mutation and determine the carrier status of each patient and partner.
15788540|NCT04544449|Drug|fenebrutinib|Participants will receive fenebrutinib.
15788541|NCT04544449|Drug|ocrelizumab|Participants will receive ocrelizumab.
15788542|NCT04544449|Drug|placebo|Participants will receive fenebrutinib-matching placebo and ocrelizumab-matching placebo.
15788547|NCT04544423|Other|Block group|Patients received lumbar erector spinae plane Block before operation
15788549|NCT04544397|Procedure|Catheter Ablation for AF|Pulmonary vein isolation (PVI) is the mainstay goal of atrial fibrillation (AF) ablation procedures, especially in paroxysmal AF (PAF), and is recommended during all AF ablation procedures. PVI can be obtained with different techniques, using 3D-mapping systems guiding point-by-point radiofrequency (RF) ablation procedures or balloon-based ablation systems (cryo- or laser balloon), introduced to simplify catheter ablation for AF. In particular, the 2nd generation of visually guided laser balloon ablation system (LB2) makes use of laser energy to achieve PVI, leading to better PV occlusion and isolation compared to the 1st generation.
15788550|NCT04544371|Device|gastric ultrasound|Focused gastric ultrasound was performed in semi-sitting position then right lateral position mindray curved transducer for examination of abdomen with low frequency (2-5 MHz) by a trained physician. The antrum of the stomach was located in the epigastrium after a sweep of the probe from left to right subcostal margins. This could be done using left lobe of liver as an anterior landmark and descending abdominal aorta as a posterior landmark
15788551|NCT04544371|Procedure|nasogastric tube insertion|Nasogastric tube (18-french) was inserted after induction of anaesthesia and endotracheal intubation. Aspiration of gastric contents was performed through gentle suction using 50 ml syringe with synchronous epigastric massage and gentle movement of nasogastric tube in and out for 10 minutes after confirmation of nasogastric tube position.
15788552|NCT04544358|Behavioral|BAILAMOS©|BAILAMOS© includes a 4-month, twice-weekly dance program. The PI and a professional dance instructor co-developed an extensive BAILAMOS© Dance Manual and class-by-class schedule.
15788553|NCT04544345|Device|His bundle pacing, AV optimized|A Select Secure 3830 (Medtronic, MN, USA) pacing lead will be placed on the bundle of His. In case of unsuccessful His capture, left bundle branch area pacing is going to be targeted. Pacemaker will be programmed to a low base rate and a high tracking rate to allow for intrinsic sinus rhythm. AV delay will be optimized with echocardiography to the shortest AV delay without truncation of the A wave on transmitral pulse wave doppler.
15788554|NCT04544345|Device|Backup VVI pacing|Pacemaker will be programmed to VVI (ventricular only) mode with low base rate as to allow for intrinsic sinus rhythm without AV optimization.
15788555|NCT04544319|Drug|Zemiglo 50mg and Forxiga 10mg|Each component of Gemigliptin 50mg QD and Dapagliflozin 10mg QD
15788556|NCT04544319|Drug|Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg|Fixed-dose Combinations of Gemigliptin/Dapagliflozin 50/10 mg QD
15788557|NCT04544306|Other|Partial oral antimicrobial therapy|Switch intravenous antimicrobial therapy to oral after an initial period of 10 days to oral antimicrobial therapy. Antimicrobial choices will be guided by antimicrobial susceptibilities.
15788558|NCT04544293|Drug|Molgramostim|Molgramostim 300 µg nebulizer solution
15788559|NCT04544293|Drug|Placebo|Matching placebo
15788560|NCT04544280|Drug|Xeomin Injectable Product|Intramuscular injection
15788561|NCT04544267|Biological|Quadrivalent influenza vaccine, high-dose|Pharmaceutical form: suspension for injection in a pre-filled syringe; route of administration: intramuscular
15788562|NCT04544267|Biological|Quadrivalent influenza vaccine, standard dose|Pharmaceutical form: suspension for injection in a pre-filled syringe; route of administration: intramuscular
15788563|NCT04544254|Procedure|Bilateral transversus thoracis muscle plane block|The block will be performed in between intercostal space 4 and 5, lateral from sternum, with ultrasound guided. Twenty milliliters bupivacaine 0.5% 1mg/body weight will be injected between internal intercostal muscle and transversus thoracis muscle on both sides.
15788564|NCT04544254|Procedure|Control|A needle will be place in the similar area to the transversus thoracis muscle plane block, but no drugs will be injected to the area
15788565|NCT04544241|Behavioral|Cancer Survivorship Leadership Training for Clergy Wives and Widows|We will meet with Clergy Wives and Widows monthly for 2-3 hours over 10 months. These sessions will be delivered using innovative online format through Zoom over the ten months. During each meeting session, experienced community and academic leaders will present their expertise with relationship to cancer survivorship and caregiving. These individuals will have extensive experience in the particular area they are presenting in. In addition, allotted time will be given for discussion and group activities that can be performed virtually. To receive credit for completion of the training program, each participant must complete the training and deliver a group workshop. All clergy wives and widows will complete a demographic questionnaire, in addition to pre- and post- intervention questionnaires
15788566|NCT04544228|Procedure|Serratus Anterior Plane Block Technique|The patient will be placed in Lateral Decubitus with a surgical side upwards with arm abduction. A linear ultrasound transducer (6-13 MHz) will be placed on the patient's midaxillary line in the transverse plane, at the level of the fifth rib, with the indicator oriented toward the operator's left. With the rib, pleural line, and overlying serratus anterior and latissimus dorsi muscles visualized, local infiltration of the skin and subcutaneous tissue will be applied by 2-3ml of lidocaine 2%. Then, using ultrasound guidance, A 38-mm 22-gauge regional block needle will be advanced in-plane at an angle of approximately 45 degrees towards the fifth rib. The expecting depth for this block is 1-4 cm. After aspiration, injection 30ml local anesthetic mixture will be injected anteriorly to the rib and deep to the serratus anterior muscle.
15788567|NCT04544228|Procedure|General anesthesia|"Induction of general anaesthesia will be performed using a regimen of IV 2 μg/kg fentanyl and propofol IV 2 mg /kg. Tracheal intubation will be facilitated using 0.5 mg/kg IV of rocuronium.
~Anaesthesia will be maintained with inhaled sevoflurane 2-2.5% in oxygen enriched air (FiO2=0.5). Maintenance doses of rocuronium 0.1 m\kg will be provided every 30 minutes.
~The residual neuromuscular blockade will be reversed using neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg), and extubation will be performed after complete recovery of the airway reflexes."
15788568|NCT04544228|Drug|bupivacaine +ketamine|30 ml bupivacaine 0.25% + 1 ml ketamine (50mg) in Serratus Anterior Plane Block.
15788569|NCT04544228|Drug|bupivacaine + neostigmine|30 ml bupivacaine 0.25% + 1 ml neostigmine (500 μg)in Serratus Anterior Plane Block.
15788570|NCT04544228|Drug|bupivacaine +saline|30 ml bupivacaine 0.25% + 1 ml normal saline in Serratus Anterior Plane Block.
15788571|NCT04544215|Biological|Dosage 1 of MPCs-derived exosomes|7 times aerosol inhalation of MPCs-derived exosomes (8.0*108 nano vesicles/3 ml at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7).
15788572|NCT04544215|Biological|Dosage 2 of MPCs-derived exosomes|7 times aerosol inhalation of MPCs-derived exosomes (16.0*108 nano vesicles/3 ml at Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7).
15788573|NCT04544215|Biological|No MPCs-derived exosomes|No aerosol inhalation of MPCs-derived exosomes
15788574|NCT04544202|Drug|Dabrafenib and Trametinib|"The starting dose of the combination treatment will be administered as follows:
~Dabrafenib, 150 mg, twice daily (BID);
~Trametinib, 2.0 mg, once daily (QD)"
15788575|NCT04544202|Drug|Dabrafenib|If administration of dabrafenib is interrupted or permanently discontinued, administration of trametinib may continue.
15788576|NCT04544202|Drug|Trametinib|If administration of trametinib is interrupted or permanently discontinued, administration of dabrafenib may be continued.
15788580|NCT04544176|Other|Observational|There will be no interventions in this study, it is purely observational using data already collected.
15788581|NCT04544163|Drug|Magnesium sulfate- Fentanyl|drug administration before intubation
15788582|NCT04544163|Drug|Fentanyl 4Mcg/kg|drug administration with induction of anesthesia
15788583|NCT04544163|Drug|Fentanyl 2Mcg/kg|drug administration with induction of anesthesia
15788584|NCT04544163|Drug|Lidocaine 1.5 mg/kg|drug administaration 90 sec before intubation
15788585|NCT04544137|Behavioral|BOKS|BOKS is an evidence-based physical activity program developed by Reebok to get kids active and establish a lifelong commitment to health and fitness. It was originally developed and tested as a 12-week program offered before or after school. In the present study, BOKS will be offered four days per week for eight weeks over the summer at a public park in one low-income community. The program will run one-hour prior to lunch service by the USDA's Summer Food Service Program. The BOKS curriculum includes lesson plans for 40-45 minute classes that follow the same daily format and focus on a functional fitness skill of the week (squat, plank, push up, etc) and engage participants in team-oriented games.
15788586|NCT04544124|Behavioral|Contingency management|Incentives will be provided for treatment attendance over a 12-week period.
15788587|NCT04544111|Drug|Trametinib|2mg by mouth daily
15788588|NCT04544111|Drug|Dabrafenib|150 mg twice daily (OR at dose the patient previously tolerated)
15788589|NCT04544111|Drug|PDR001|400mg IV every 4 weeks
15788590|NCT04544098|Drug|177Lu-DOTATATE|The treatment regimen will consist of four administrations of 177Lu-DOTATATE-two intra-arterial followed by two intravenous, two months apart (+/- 2 weeks), with renal protective amino acid solution co-administration. The activity per cycle will be fixed for each patient: patients will receive two intra-arterial cycles of 7.4 GBq, unless toxicity occurs requiring dose modifications.
15788629|NCT04543825|Device|Cardiopulmonary exercise testing|Subjects will perform cardiopulmonary exercise testing which consists of biking on a cycle ergometer (recumbant stationary bicycle) while breathing through a mouthpiece or mask to measure the oxygen and carbon dioxide in the subject's breath.
15788591|NCT04544085|Behavioral|noise management|The intervention mainly includes the following three parts: control of noise source, control of noise transmission and personal protection of noise receiver.(1) control of noise source:equipment maintenance,alarm management,set quiet time,etc.;(2)control of noise transmission:improvement of architectural design;(3)personal protection of noise receiver:providing patients with earmuffs or earplugs.
15788592|NCT04544059|Drug|Lenalidomide|Lenalidomide orally 25 mg per day was administered on days 1 through 10 of each cycle and delivered concomitantly with standard dose R-CHOP-21 regimen (rituximab 375 mg/m2, cyclophosphamide 750 mg/m2, doxorubicin 50 mg/m2 or Liposome doxorubicin 30mg/m2, vincristine 1.4 mg/m2 [capped at 2.0 mg], all on day 1; prednisone 100 mg per day on days 1 through 5). All patients received aspirin 100mg per day prophylaxis throughout, unless they were on therapeutic dose warfarin or low molecular weight heparin for intercurrent conditions. The treatment continued for a maximum of six to eight cycles or until disease progression. Tumor lysis prophylaxis, antiemetics, and supportive care were standard of care.
15788593|NCT04544046|Other|Supportive Oncology Care at Home|Remote monitoring of symptoms, vital signs, and body weight with home-based care to address any concerning issues identified.
15788594|NCT04544046|Other|Usual Care|Standard care arm will receive standard oncology care and attend regular clinic visits.
15788595|NCT04544033|Diagnostic Test|interleuken 6 level measurment|Detection of IL6 level using ELISA technique.
15788596|NCT04544033|Diagnostic Test|Interleukin-6 Gene-174C detection|The genotyping of the polymorphisms in IL-6 promoter G-174C (rs1800795) will be performed using PCR-RFLP technique.
15788597|NCT04544020|Dietary Supplement|NG feeding|NG feeding
15788599|NCT04543994|Drug|Remestemcel-L|An ex vivo culture-expanded adult allogeneic bone marrow derived mesenchymal stem cell product for the treatment of medically refractory ulcerative colitis
15788600|NCT04543994|Drug|Remestemcel-L|An ex vivo culture-expanded adult allogeneic bone marrow derived mesenchymal stem cell product for the treatment of medically refractory ulcerative colitis
15788601|NCT04543994|Other|Placebo|Normal saline
15788602|NCT04543981|Diagnostic Test|Diagnostic Criteria for Tempro-mandibular Disorders(DC/TMD)|diagnostic sheet include questions to be answered by the patients and others include examinations will be done by the investigator
15788603|NCT04543968|Dietary Supplement|Extra-virgin olive oil (EVOO) intake|MD patients will receive EVOO daily as dietary supplements for 12 months. After that, patients will be randomly assigned in 1:1 ratio to continue on receiving EVOO as their dietary supplements for another 6 months.
15788604|NCT04543968|Dietary Supplement|Extra-virgin olive oil (EVOO) intake and withdraw|MD patients will receive EVOO daily as dietary supplements for 12 months. After that, patients will be randomly assigned in 1:1 ratio to withdraw from receiving EVOO as their dietary supplements for another 6 months.
15788605|NCT04543955|Drug|Telotristat (Low-Dose)|Participants in this group will receive Lutetium Lu 177 Dotate (Lutathera) by IV every 2 months (Q8weeks) for a total of 4 doses. They will also receive oral Telotristat at 750mg per day (250mg TID) for 20 months.
15788606|NCT04543955|Drug|Telotristat (High-Dose)|Participants in this group will receive Lutetium Lu 177 Dotate (Lutathera) by IV every 2 months (Q8weeks) for a total of 4 doses. They will also receive oral Telotristat at 1500mg per day (500mg TID) for 20 months.
15788607|NCT04543942|Drug|Alcohol|Alcohol will be administered by IV infusion (60mg%). Brain activation during response inhibition (BARI) will be assessed using fMRI during performance of the stop signal task.
15788608|NCT04543929|Behavioral|exercise|partially supervised and home-based exercise activity
15788609|NCT04543916|Drug|Venetoclax 50 MG|Escalating doses to determine recommended phase 2 dose (RP2D)
15788610|NCT04543916|Drug|Venetoclax 100 MG|Escalating doses to determine recommended phase 2 dose (RP2D)
15788611|NCT04543916|Drug|Venetoclax 200 MG|Escalating doses to determine recommended phase 2 dose (RP2D)
15788612|NCT04543916|Drug|Venetoclax 400|Escalating doses to determine recommended phase 2 dose (RP2D)
15788613|NCT04543916|Drug|Venetoclax 600|Escalating doses to determine recommended phase 2 dose (RP2D)
15788614|NCT04543916|Drug|Irinotecan 60 mg/m2|Intravenously (IV), days 1, 8, and 15
15788615|NCT04543916|Drug|Venetoclax (RP2D)|orally, once per day
15788616|NCT04543903|Device|Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)|An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.
15788617|NCT04543890|Radiation|Hyperfractionated radiotherapy|Thoracic radiotherapy (45 Gy/30 fractions) for the Hyperfractionated Arm and prophylactic cranial irradiation (25 Gy/10 fractions).
15788618|NCT04543890|Radiation|Hypofractionated radiotherapy|Thoracic radiotherapy (45 Gy/15 fractions) for the Hypofractionated Arm and prophylactic cranial irradiation (25 Gy/10 fractions).
15788619|NCT04543890|Drug|Etoposide|Etoposide will be administered IV 100mg/m2 on days 1-3, 22-24, 43-45 and 64-66.
15788620|NCT04543890|Drug|Cisplatin|Cisplatin will be administered IV 80mg/m2 on days 1, 22, 43 and 64.
15788621|NCT04543877|Dietary Supplement|Inulin|Consume 12 grams/day of inulin for 6 weeks (Day 9 - 53).
15788622|NCT04543877|Dietary Supplement|Maltodextrin|Consume 12 grams/day of maltodextrin for 6 weeks (Day 9 - 53).
15788623|NCT04543877|Biological|Ty21a Typhoid Fever Vaccine|All participants will receive the vaccine. One capsule is swallowed on alternate days, e.g. days 40, 42, 44, and 46 for a total of 4 capsules.
15788624|NCT04543864|Device|Electric intraoral welding device|welding metal framework to the implants in completely edentulous maxilla by electric welding device intraorally
15788625|NCT04543864|Device|casting|casting the metal framework
15788626|NCT04543851|Device|CARA - carbon fibre adjustable re-usable accessory for breast positioning|Breast positioning to alleviate infra-mammary fold and lateral breast sag
15788627|NCT04543838|Diagnostic Test|Intervention|Electroencephalogram (EEG) and Somatosensory evoked potentials (SSEP) intraoperative monitoring
15788628|NCT04543838|Other|Standard of Care BP management|If blood pressure (BP) control is determined to be necessary, standard of care practices to manage it will be implemented
15788630|NCT04543812|Drug|Ferric citrate|Ferric citrate will be provided as a 1g tablet. All intervention doses will be based on hemoglobin levels.
15788631|NCT04543812|Drug|Placebo|Matching placebo will be provided as a 1g tablet. All intervention doses will be based on hemoglobin levels.
15788632|NCT04543799|Device|polysomnography, actigraphy, questionnaires|sleep quality recording
15788633|NCT04543786|Device|Transcutaneous spinal cord stimulation|Neuromodulation with transcutaneous spinal cord stimulation applied on lower back adjacent to spine for 30-60 minutes for 5 consecutive days.
15788634|NCT04543773|Device|rTMS|rTMS will be delivered to the fMRI-determined DLPFC hotspot according to conventional parameters for clinical treatment (e.g., excitatory: 75 trains of 40 pulses, 10Hz, up to 3000 pulses). Magnetic field strength will be up to 120% of resting motor threshold. Ramp up of magnetic field strength may be utilized in the first week for tolerability. Side effects will be monitored and coil angle adjusted to improve tolerability if necessary.
15788635|NCT04543760|Other|Prone position|prone positioning in spontaneous ventilation
15788636|NCT04543760|Other|Supine position|supine positiong in spontaneous ventilation
15788637|NCT04543747|Device|HeartWare Ventricular Assist Device|The Medtronic HVAD® System is comprised of three major components: the HVAD Pump with inflow and outflow conduits, a Controller and power sources. In addition to these components, the system includes a Monitor, Battery Charger, AC and DC power adapters, and a Carrying Case. The HVAD® System is indicated for hemodynamic support in patients with advanced, refractory left ventricular heart failure; either as a bridge to cardiac transplantation (BTT), myocardial recovery, or as destination therapy (DT) in patients for whom subsequent transplantation is not planned.
15788638|NCT04543734|Device|HemoScreen hematology analyzer|The use of HemoScreen for self-testing of blood values
15788639|NCT04543721|Device|24-h-ABPM|24-h- blood pressure measurement and pulse wave analysis
15788640|NCT04543708|Procedure|Incision drainage|"Oropharyngeal pre-anesthesia is performed with 10% xylocaine spray, then submucosal anesthesia of the anterior pillar of the tonsil is performed with 2 ml of Rapidocaine or Rapidocaine 1 or 2% adrenaline. A scalpel incision is made with the search for the abscess pocket with a crile. If pus is present, a NaCl / Betadine rinse is performed. A syringe puncture can help locate the abscess if needed. The duration is approximately 15 minutes.
~If no purulent pouch is found, the procedure is completed with tonsillectomy under general anesthesia."
15788641|NCT04543708|Procedure|Tonsillectomy|Under general anesthesia, in dorsal decubitus, an autostatic mouth opener is placed, an incision of the anterior pillar of the tonsil allows the opening of the capsular space, along which the entire tonsil is dissected until complete extraction, hemostasis is performed, then the patient is awakened. The duration is approximately 30 minutes.
15788642|NCT04543695|Combination Product|Concurrent Chemoradiotherapy|"Radiotherapy:
~50Gy in 25 fractions to the primary tumor and to mesorectal, presacral,and internal iliac lymph nodes.
~Concurrent chemotherapy:
~Capecitabine 1650 mg/m2/d"
15788643|NCT04543695|Drug|XELOX|"Intravenous infusion of oxaliplatin (130 mg/m2 over 2 h) on day 1 and oral administration of capecitabine (1000 mg/m2 twice daily) from day 1 to day 14, is repeated every 3 weeks for 6 cycles.
~6 courses，3 weeks per course"
15788644|NCT04543695|Drug|mFOLFOX|Administration of l-LV (400 mg/m2) and oxaliplatin (85 mg/ m2) by intravenous infusion over 2 h, followed by rapid intravenous infusion (iv) of 5-FU (400 mg/m2) and then slow infusion (civ) of 5-FU (2400 mg/m2 over 46 h), is repeated every 2 weeks for 9 cycles.
15788645|NCT04543695|Procedure|TME|Total mesorectal excision
15788646|NCT04543682|Drug|0.125 ng/kg/min Iloprost|Drug administration through a catheter (inserted at the end of the surgical procedure) begins 24±2 hours after surgery: 0.125 ng/kg/min Iloprost for a duration of 24 hours
15788647|NCT04543682|Drug|0.25 ng/kg/min Iloprost|Drug administration through a catheter (inserted at the end of the surgical procedure) begins 24±2 hours after surgery: 0.25 ng/kg/min Iloprost for a duration of 24 hours
15788648|NCT04543682|Procedure|open reduction and internal fixation with an angular stable plate (PHILOS)|open reduction and internal fixation with an angular stable plate (PHILOS)
15788649|NCT04543669|Biological|Adacel®|Vaccine for TdaP-Tetanus, diphtheria, acellular pertussis
15788650|NCT04543656|Behavioral|AI-Based Lifestyle Recommendations|The intervention provides participants with automated and personalized lifestyle recommendations involving a sophisticated analytics engine using advanced statistics and machine learning.
15788651|NCT04543656|Other|No Lifestyle Recommendations|The control group receives an identical activity tracker and BP monitor in order to objectively assess the effectiveness of the experimental group intervention.
15788654|NCT04543630|Procedure|Sinus floor augmentation|Sinus floor augmentaion using the lateral window technique
15788655|NCT04543617|Drug|Tiragolumab|Tiragolumab at a fixed dose of 600 milligrams (mg) administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
15788656|NCT04543617|Drug|Atezolizumab|Atezolizumab at a fixed dose of 1200 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
15788657|NCT04543617|Drug|Tiragolumab Matching Placebo|Tiragolumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
15788658|NCT04543617|Drug|Atezolizumab Matching Placebo|Atezolizumab matching placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
15788659|NCT04543604|Behavioral|Leatlet + visual aid (pictogram)|The questionnaires were collected at baseline (at the end of the initial interview and once the patients assigned within the test groups declared to have read the leaflet) at 3- and 6-month follow-up. The questionnaire included demographic data such as age, gender, civil status, occupation (coded according to the CNO-11(2010), presence of systemic disorder, smoking and number of implants. Moreover, data concerning history of periodontal disease and type of prosthesis were further documented and added to demographics.
15788660|NCT04543604|Behavioral|Leaflet + no visual aid (no pictogram)|The questionnaires were collected at baseline (at the end of the initial interview and once the patients assigned within the test groups declared to have read the leaflet) at 3- and 6-month follow-up. The questionnaire included demographic data such as age, gender, civil status, occupation (coded according to the CNO-11(2010), presence of systemic disorder, smoking and number of implants. Moreover, data concerning history of periodontal disease and type of prosthesis were further documented and added to demographics.
15788661|NCT04543591|Drug|Ravulizumab|Weight-based doses of ravulizumab will be administered intravenously as loading dose regimen followed by maintenance dosing every 8 weeks.
15788662|NCT04543591|Drug|Placebo|Matching placebo
15788663|NCT04543591|Other|Best supportive care|Participants will receive medications, therapies, and interventions per standard hospital treatment protocols (unless specifically prohibited by the protocol).
15788664|NCT04543565|Drug|Pradefovir Mesylate;Placebo of Tenofovir disoproxil fumarate tablet|Once daily
15788665|NCT04543565|Drug|Tenofovir disoproxil fumarate tablet;Placebo of Pradefovir Mesylate|Once daily
15788666|NCT04543552|Device|Bladder scan|Bladder Scanner, or Biocon-900 is an ultrasonic imaging device that has been developed to measure post-void residual volume of the bladder non-invasively. The images and measurements are obtained by applying a probe onto the abdomen (i.e. bladder). As it scans, the scanner constructs 12 cross-sectional images at 15 degree interval using the reflection signals from urine in the bladder and extracts the position of the bladder wall as well. During urodynamic studies, the bladder scan will measure the infused volume in order to assess difference between the infused and scanned volumes.
15788667|NCT04543539|Combination Product|IN.PACT™ AV Drug Coated Balloon (DCB) - Primary Cohort|For the treatment of obstructive lesions up to 100 mm in length in the native arteriovenous dialysis fistulae with reference vessel diameters of 4 to 12 mm.
15788668|NCT04543539|Combination Product|IN.PACT™ AV Drug Coated Balloon (DCB) - Extended Cohort|For treatment of stenosis in the AV circuit
15788669|NCT04543526|Device|easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)|Investigational device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical). Device for creating anastomoses during standard and robot-assisted laparoscopic RYGB, manufactured by Ezisurg Medical.
15788670|NCT04543513|Other|Real-time functional magnetic resonance neurofeedback (rtfMRI-nf)|Real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) is a procedure using an MRI scanner that allows participants to observe their own neural activity in the moment. They are taught to self-regulate this activity during a task.
15788671|NCT04543500|Other|Real-time functional magnetic resonance neurofeedback (rtfMRI-nf)|Real-time functional magnetic resonance imaging neurofeedback (rtfMRI-nf) is a procedure using an MRI scanner that allows participants to observe their own neural activity in the moment. They are taught to self-regulate this activity during a task.
15788672|NCT04543487|Other|Therapeutic touch|Therapeutic touch was applied twice to the women in the intervention group in addition to routine practices. The first application was performed in the active phase of the first stage of labour, and the second was done in the second stage of labour.
15788673|NCT04543474|Other|Low Lactose Diet|First, there was a run-in period (day 1-14), during which patients were randomly assigned by computer-generated bloc randomization to either the LLD or the LFD for 21 days (day 15-35). A dietician educated the participants on the first interventional diet. This phase was followed by a wash-out period of 21 days (day 36-56) with resumption of a normal balanced daily-life diet before crossing over to the alternate interventional diet (day 57-77). There were visits at the end of the washout phase with an instruction on the second interventional diet and at the end of the study.
15788674|NCT04543474|Other|Low FODMAP Diet|First, there was a run-in period (day 1-14), during which patients were randomly assigned by computer-generated bloc randomization to either the LLD or the LFD for 21 days (day 15-35). A dietician educated the participants on the first interventional diet. This phase was followed by a wash-out period of 21 days (day 36-56) with resumption of a normal balanced daily-life diet before crossing over to the alternate interventional diet (day 57-77). There were visits at the end of the washout phase with an instruction on the second interventional diet and at the end of the study.
15788675|NCT04543448|Other|Traditional Rehabilitation for multiple sclerosis|Traditional rehabilitation program include strengthening exercises for the muscles needed, balance and coordination exercises according to the individual's level, stretching for the lower limbs.
15788676|NCT04543448|Other|Cervical mobilization for multiple sclerosis|Cervical mobilization program include myofascial relaxation techniques and mobilization to cervical spine in addition to traditional program.
15788677|NCT04543422|Dietary Supplement|Green tea|Green tea extract capsules
15788678|NCT04543422|Other|Placebo|Placebo containing inert material.
15788679|NCT04543409|Biological|Benralizumab|Solution for injection in a single accessorized prefilled syringe (APFS) will be administered subcutaneously (SC), 1 mL fill volume
15788680|NCT04543409|Biological|Matching placebo|Matching placebo solution for injection in APFS, 1 mL fill volume. Placebo solution will be administered subcutaneously (SC), 1 mL fill volume
15788681|NCT04543396|Other|Resistance exercise|A training program designed to enhance core strength, stability, and function will be performed on the Tonal device. Training sessions will occur twice weekly for eight weeks. Performance of this program will be supervised by a designated and clinically trained research team member who will not conduct the statistical analysis and subsequently not be blinded to Group assignment. The program will last approximately 20 minutes in length and incorporate the a series of progressive exercises.
15788682|NCT04543383|Drug|JNJ-70033093|Participants will receive a single oral dose of JNJ-70033093 on Day 1 in two of the 3 periods.
15788683|NCT04543383|Biological|4-Factor Prothrombin Complex Concentrate (4F-PCC)|Participants will receive IV infusion of 4-Factor Prothrombin Complex Concentrate (4F-PCC) on Day 1 in two of the 3 periods.
15788684|NCT04543383|Biological|Recombinant Human Factor VIIa (rFVIIa)|Participants will receive IV injection of rFVIIa on Day 1 in two of the 3 periods.
15788685|NCT04543383|Biological|Placebo matching to 4F-PCC|Participants will receive placebo matching to 4F-PCC on Day 1 of one of the 3 study periods.
15788686|NCT04543383|Biological|Placebo matching to rFVIIa|Participants will receive placebo matching to rFVIIa on Day 1 of one of the 3 study periods.
15788687|NCT04543370|Drug|Edasalonexent 2000 mg TID|CAT-1004 capsules
15788688|NCT04543370|Drug|Midazolam 2 MG/ML|2 mg/ml syrup
15788689|NCT04543370|Drug|Deflazacort 36Mg Tab|36 mg tablets
15788690|NCT04543357|Other|Blood Draw|Blood Samples for NAb and ADA to AAV9
15788691|NCT04543344|Drug|Recifercept|recifercept powder for solution for injection
15788692|NCT04543344|Other|Placebo|solution for injection
15788693|NCT04543331|Drug|brolucizumab|There is no treatment allocation. Patients administered Brolucizumab by prescription that have started before inclusion of the patient into the study will be enrolled.
15788694|NCT04543318|Procedure|Deep temporal nerves|"Surgical procedure:
~Group A Exploration on the affected side a facelift-type incision will be performed, and an anterior subcutaneous flap is then will be lifted for several centimetres. In the inferior zygomatic region, the plane of elevation is deepened into the sub-SMAS plane and a composite flap elevated for several centimetres. Following elevation in this plane, the distal facial nerve branches will be identified. The distal portion of the zygomatic nerve is usually located midway between the oral commissure and the helical root. and was confirmed by nerve stimulator.
~The deep temporal fascia and temporalis muscle will be incised along the temporal fusion line and will be reflected from the skull to expose the divisions of the deep temporal nerves and the longest branch was traced and prepared for anastomosis end to end with the zygomatic branch after confirming the eyelid supply."
15788695|NCT04543318|Procedure|massteric nerve|group B The same procedure as group A except tracing the masseteric nerve related to masseter muscle and anastomosis will be the same
15788696|NCT04543305|Drug|PRT1419|PRT1419 will be administered orally
15788697|NCT04543292|Device|MATFILL (PTFE)|Filling of the prosthetic chimney with the compressed material
15788698|NCT04543279|Drug|Fostamatinib|Fostamatinib will be supplied by Rigel Pharmaceuticals.
15788699|NCT04543279|Drug|Ruxolitinib|Ruxolitinib is commercially available.
15788700|NCT04543266|Procedure|Surgery|Resection of tumors
15788702|NCT04543240|Device|Integra™ dermal regeneration template|Integra a biologic dressing for deep wounds or large soft tissue defects that penetrate to the level of bone
15788703|NCT04543227|Behavioral|Opioid Use 90-Days Post Treatment|Survey conducted 90-days post treatment to determine use of opioid medications in relation to burn or knee arthroscopy pain
15788704|NCT04543214|Other|Enhanced recovery after surgery|Enhanced recovery after surgery (ERAS) protocols are multimodal perioperative care pathways designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response after surgery. It benefits patient by reducing complications and enhancing recovery and saves resources for the health care system. In this concept, surgeons work collaboratively with anesthesiologist, nurses, nutritionists and physical therapists to develop and manage the perioperative care.
15788705|NCT04543201|Behavioral|Early START visit using checklist over telephone or zoom|"Prior to visit subject receives pre-visit educational guide and copy of advance directive form
~Follow up surveys:
~Immediate: provider feedback survey
~2-4 weeks after visit: subject feedback survey and caregiver/family feedback survey
~After subject death: caregiver/family survey"
15788706|NCT04543188|Drug|PF-07284890|PF-07284890 will be administered orally, daily for 21 consecutive days (21-day cycle)
15788707|NCT04543188|Drug|Binimetinib|Binimetinib will be administered together with PF-07284890 orally, 45mg twice daily
15788708|NCT04543188|Drug|Midazolam|Midazolam will be administered 7 days before start of study drug, on Cycle 1 Day 1, and on Cycle 1 Day 15
15788709|NCT04543175|Other|Taste disorder´s test|Each patient performed their own test placing three drops with a disposable dropper from each bottle into the center of the tongue for whole-mouth testing.
15788710|NCT04543149|Diagnostic Test|Flow cytometric immunophenotyping|To evaluate T cell subsets and monocyte
15788711|NCT04543136|Device|New intermittent catheters variation 1 and 2 for males|The new catheters are not named at this point but are intended for intermittent drainage of the bladder.
15788712|NCT04543123|Device|tDCS treatment|Participants visited the hospital four times (biweekly for two weeks). During their second visit, a research nurse instructed each participant on use of home-based tDCS equipment (YDS-301N; Ybrain Inc., Seongnam-si, Korea) and all participants thereafter conducted tDCS treatment at home once a day for 30 minutes (five times per week).
15788713|NCT04543123|Drug|Antidepressant Drug(escitalopram)|Participants in both active and sham groups were prescribed escitalopram in combination with tDCS treatment.
15788714|NCT04543110|Drug|Durvalumab|Durvalumab prior to Radical Cystectomy in Patients With Muscle-Invasive Bladder Carcinoma
15788715|NCT04543110|Radiation|Immune Modulating Radiation|Neoadjuvant Immune-Modulating Radiation prior to Radical Cystectomy in Patients With Muscle-Invasive Bladder Carcinoma
15788716|NCT04543097|Behavioral|Vocational Support|"Participants randomised to receive vocational advice will all be offered:
~Step 1, contact by phone to undertake an assessment with a trained Vocational Support Worker (VSW) to identify obstacles to Return to Work (RTW) and support RTW planning.
~Step 2, face-to-face (in person or by videoconference) in-depth discussion of obstacles to RTW and further support for RTW planning.
~Step 3, contact by the VSW (with participant consent) with the participants' workplace.
~The frequency of contact will be individualised to the needs of participants and the offer of support continued until sustained RTW (defined as return to any work for at least 4 weeks) or until 6 months of absence, after which participants will be signposted to other services."
15788717|NCT04543084|Behavioral|Logbook|Participants will record practice in a logbook.
15788722|NCT04543058|Device|BeatPark Application|"The participant walks for 30 minutes a day, 5 day a week for 4 weeks. During the walking session, BeatPark Application delivers synchronized music adapted to the patient walking.
~The application allows participants to know the progress of their session through graphical representation and voice messages, informs them at the end of the session of their performance and congratulate them for their efforts."
15788723|NCT04543058|Other|BeatPark Application without synchronized music|"The participant walks for 30 minutes a day, 5 days a week for 4 weeks. During the walking session, BeatPark Application delivers random music at random tempo.
~The application allows participants to know the progress of their session through graphical representation and voice messages, informs them at the end of the session of their performance and congratulate them for their efforts."
15788754|NCT04542759|Drug|Besifloxacin Ophthalmic|Prophylaxis for endophthalmitis
15788755|NCT04542759|Drug|Hydroxypropyl Methylcellulose Ophthalmic Ophthalmic Solution|Placebo
15788838|NCT04542109|Behavioral|READyR B|Active comparator. Two sessions to deliver general information about dementia-related care needs.
15788724|NCT04543058|Other|BeatPark Application without music|The participant walks for 30 minutes a day, 5 days a week for 4 weeks. During the walking session, BeatPark Application does not deliver music. The application allows participants to know the progress of their session through graphical representation and voice messages, informs them at the end of the session of their performance and congratulate them for their efforts.
15788725|NCT04543045|Other|not an intervention|not an intervention
15788726|NCT04543032|Other|sensorimotor training|Sensorimotor exercises progressed from stable surfaces to unstable surfaces, training gait in a line (tandem walk or walking straight) followed by gait including change in directions, gait without obstacles to gait with obstacles, change in the support base (feet apart and then together), physical exercises with eyes opened and closed, always respecting the functional capacity of each patient and progressively increasing the difficulty of each exercise. To help the training, cones, balance board, bars, mats and a mini-trampoline will be used. According to the patient progress, the exercises will be combined, generating circuits
15788727|NCT04543006|Diagnostic Test|serology|blood sample of 10 ml twice (6 and 12 months after the Covid-19)
15788728|NCT04542993|Dietary Supplement|Zinc Picolinate|Zinc Picolinate (50 mg PO TID x 5 days)
15788729|NCT04542993|Dietary Supplement|Resveratrol|Resveratrol 2 grams po BID x 5 days
15788730|NCT04542993|Dietary Supplement|Zinc Picolinate Placebo|Zinc Picolinate Matched Placebo PO TID x 5 days
15788731|NCT04542993|Dietary Supplement|Resveratrol Placebo|Resveratrol Matched Placebo PO BID x 5 days
15788732|NCT04542980|Diagnostic Test|SARS-CoV2 Autoantibody detection|Through the data collected from this study we hope to support the development of an ELISA assay for the detection of IgM and IgG autoantibodies produced in response to the presence of SARS-CoV2
15788733|NCT04542967|Biological|Biological|"An administration unit of 200 ml convalescent plasma intravenous infusion every 24 hours for two doses.
~If a third dose of convalescent plasma is necessary, it may be used, as long as an evaluation of the research team is carried out."
15788734|NCT04542954|Other|Optimized Management of Covid-19 Positive Kidney Transplant Recipients: Single Center Experience from the Middle East|Optimized Management of Covid-19 Positive Kidney Transplant Recipients: Single Center Experience from the Middle East
15788735|NCT04542941|Biological|COVID Convalescent Plasma|Plasma collected from recovered COVID 19 individuals
15788736|NCT04542928|Behavioral|nurse facilitated face care group|The experimental group is required to receive a nurse leading 50- minute face care group every two week
15788737|NCT04542915|Other|No intervention|No intervention.
15788738|NCT04542902|Biological|Dermatophagoides pteronyssinus allergen|Dermatophagoides pteronyssinus allergen is required to perform allergen bronchial challenge test.
15788739|NCT04542902|Procedure|Blood sampling|An amount of a person's blood taken from their body for use in medical.
15788740|NCT04542902|Procedure|Bronchial challenge with allergen|Bronchial challenge is performed with D. pteronyssinus allergen. Measurements of differences in eosinophils activity after allergen challenge.
15788741|NCT04542889|Diagnostic Test|Absolute coronary flow and resistance measurements|Thermodilution-based measurements of absolute coronary resistances using the FFR pressure guide (PressureWire® Certus® from St Jude Medical Abbott) and the Rayflow® microcatheter (Hexacath, Paris, France).
15788742|NCT04542889|Diagnostic Test|IMR measurement|IMR measurement by thermodilution using the St Jude pressure guide.
15788743|NCT04542876|Drug|Guduchi Ghan Vati|Guduchi Ghan Vati was orally administered 2 tablets (1000 mg) twice daily for 2 weeks.
15788744|NCT04542863|Other|18F-DX600 PET/CT|DX600, labeled with 18F will be used as a molecular imaging tracer for PET/CT scanning
15788746|NCT04542837|Biological|KN046|Subjects enrolled in the study will be intravenously administered KN046 5mg/kg every 3 weeks (Q3W), until disease progression, or unacceptable toxicity, or withdrawal of consent, or lost to follow-up, or died, or treatment for 2 years, or the investigator decides to terminate.
15788747|NCT04542837|Drug|Lenvatinib|Subjects enrolled in the study will receive lenvatinib 12 mg (BW≥60 kg) or 8 mg (BW<60 kg) orally once a day (QD) ,until disease progression, or unacceptable toxicity, or withdrawal of consent, or lost to follow-up, or died, or treatment for 2 years, or the investigator decides to terminate.
15788748|NCT04542824|Biological|epcoritamab|Epcoritamab will be administered subcutaneously in cycles of 4 weeks i.e. 28 days. The dose-levels will be determined by the starting dose and the escalation steps taken in the trial.
15788749|NCT04542811|Other|Acupuncture|Acupuncture is a complementary therapy modality which is used by needle inserted the specific points on the body.
15788750|NCT04542798|Device|Radiofrequency COSMAN|Radiofrequency ablation and neuromodulation
15788751|NCT04542785|Other|Rate control|Treatment will be provided according to current guidelines and as such the algorithm for treatment will be differentiated based on the status of left ventricular ejection fraction. For participants with reduced left ventricular ejection fraction, beta-blockers (metoprolol and bisoprolol) will be the primary therapy. Secondary therapies may include digoxin or amiodarone. For participants with preserved left ventricular ejection fraction, the primary therapy will be beta-blockers (metoprolol and bisoprolol) or non-dihydropyridine calcium-channel blockers (verapamil) with secondary therapy consisting of digoxin or amiodarone. Pacing therapies, alone or with atrioventricular node ablation, are utilised as indicated in the view of the treating physician.
15788752|NCT04542772|Other|Mirror Therapy|Participants will receive the standard-of-care; multidisciplinary rehabilitation intervention based on their needs and tolerance, and will receive an additional 30 min of Mirror Therapy education. During Mirror Therapy education, the patients will be educated or shown how to perform MT and the patients will complete the recommended exercises on their own for 30 minutes/day for 5 days a week/ for 4 weeks. Standard Mirror Therapy Protocol will be followed.
15788753|NCT04542772|Other|Regular Rehabilitation|Participants will receive the standard-of-care, multidisciplinary rehabilitation intervention based on their needs and tolerance.
15788756|NCT04542746|Procedure|Minimally invasive surgical technique|After local anesthesia , for the sites of test group , a minimally invasive surgical technique (MIST) will be performed. The defects associated inter-dental papilla will be surgically approached with a diagonal incision following the pattern of the simplified papilla preservation flap. Flap elevation was to the buccal and oral aspect in the interdental space, An enamel matrix derivative (EMD) was applied into the defect.f A primary closure of the interdental papillae will be achieved using a 5-0 monofilament non resorbable suturing material.
15788757|NCT04542733|Drug|Everolimus|Everolimus will be given with tacrolimus.
15788758|NCT04542733|Drug|reduced dose tacrolimus|Reduced dose tacrolimus will be given with or without leflunomide
15788759|NCT04542720|Procedure|Decompression|Patients will undergo decompression alone of the supradjacent level. The surgical technique will be surgeon dependent. All surgeons will be encouraged to avoid damaging facet joints above the fusion mass, retaining 50% of the pars of the decompressed level and performing as minimal of a medial facetectomy as necessary.
15788760|NCT04542720|Procedure|Extension Fusion|Patients will undergo decompression and extension of posterior instrumentation and fusion. This may or may not include exchange of pre-existing instrumentation. The use of interbody cages will be left to the discretion of the treating surgeon.The purpose of introducing this heterogeneity is to increase the generalizability of the trial results. The fusion cohort will not utilize bone morphogenetic protein products.
15788761|NCT04542707|Procedure|joint manipulation|Thrust manipulation to the spine, hand, and foot
15788762|NCT04542707|Procedure|Exercise|Strength training, bike aerobic training, and yoga exercise
15788763|NCT04542707|Device|Soft tissue massage|Graston tool
15788764|NCT04542694|Drug|Favipiravir|200 mg coated tablets
15788765|NCT04542694|Drug|Standard of care|"Drug: Standard of Care Standard of Care will be prescribed in accordance with the recommended treatment regimens presented in the Russian guidelines for the prevention, diagnosis and treatment of COVID-19 according to the decision of the Investigator.
~Other Name: Hydroxychloroquine, chloroquine, lopinavir/ritonavir, etc."
15788766|NCT04542681|Drug|Placebo - 1st Cycle|Subjects will receive a single SQ injection of placebo/normal saline
15788767|NCT04542681|Drug|MANP - 1st Cycle|Subjects will receive a single SQ injection of MANP at a concentration of 2.5 μg/kg
15788768|NCT04542681|Drug|MANP - 2nd Cycle|Subjects will receive a single SQ injection of MANP 5 μg/kg concentration.
15788769|NCT04542668|Other|Cycling then running|Ergometer cycling Treadmill running
15788770|NCT04542668|Other|Running then cycling|Treadmill running Ergometer cycling
15788771|NCT04542668|Other|Inotropy|Adrenaline induced inotropy
15788772|NCT04542668|Other|Resting|Subjects must be minimally physically active
15788773|NCT04542655|Other|Ergometer Cycling followed by treadmill running|The participants undergo ergometer cycling, treadmill running and rest.
15788774|NCT04542655|Other|Treadmill Running followed by ergometer cycling|The participants undergo treadmill running, ergometer cycling and rest.
15788775|NCT04542655|Other|Rest|The participants undergo ergometer cycling, treadmill running and rest.
15788776|NCT04542642|Device|reSET-O|reSET-O is an FDA-authorized mobile application treatment for opioid use disorder.
15788777|NCT04542642|Device|PEAR-008|PEAR-008 is a new, game-based version of reSET-O, a mobile application treatment for opioid use disorder.
15788778|NCT04542629|Drug|RiTUXimab Injection [Rituxan]|375 MG/M2 /WEEK INFUSION
15788779|NCT04542616|Device|Baerveldt 350 vs. Ahmed ClearPath 250 tube shunt implantation|Baerveldt 350 vs. Ahmed ClearPath 250 tube shunt implantation for the treatment of severe uncontrolled glaucoma.
15788780|NCT04542603|Drug|[11C]PiB and 18F-labeled DPA-714 PET scan|One PET with [11C]PiB and One PET with [18F]DPA-714 before chemotherapy treatment begins. One more PET with [18F]DPA-714 after completion of 3-6 cycles of chemotherapy.
15788781|NCT04542564|Device|telemedicine|a mobile app and telemedicine platform to confirm good blood pressure control and may save doctor face-to-face consultation
15788782|NCT04542564|Other|usual care|These patients have unrestricted access to healthcare resources such as general outpatient clinics and emergency departments
15788783|NCT04542551|Procedure|Dilation 60-Fr non stricture|Dilation of patients with subjective dysphagia and normal endoscopy
15788784|NCT04542551|Procedure|Sham|Sham dilator for patients with subjective dysphagia and normal endoscopy
15788785|NCT04542551|Procedure|Non severe stricture - dilation with 60-Fr|Dilation of non severe stricture with 60-Fr dilator
15788786|NCT04542551|Procedure|Non severe stricture - dilation with 46-Fr|Dilation of non severe stricture with 46-Fr dilator
15788787|NCT04542551|Procedure|Severe stricture - dilation with 51-Fr|Dilation of a severe stricture with 51-Fr dilator
15788788|NCT04542551|Procedure|Severe stricture - dilation with 42-Fr|Dilation of a severe stricture with 42-Fr dilator
15788789|NCT04542538|Other|No intervention, observational study|
15788790|NCT04542499|Drug|Tavapadon|Participants will be randomized to receive tavapadon 5 to 15 mg tablet QD orally for 27 weeks.
15788791|NCT04542499|Drug|Placebo|Participants will receive placebo matching to tavapadon QD orally for 27 weeks.
15788792|NCT04542486|Procedure|"Excision of gingival hyperplasia using Thermacut burs."|Gingivoplasties and removal of excess gingival tissues using Thermacut burs.
15788793|NCT04542486|Procedure|Excision of gingival hyperplasia using the conventional scalpel technique|Excision of gingival hyperplasia in gingivoplasties using the conventional technique reverse bevel using 15c blade.
15788794|NCT04542473|Drug|Pancreatic Enzyme|CREON micro 5000
15788795|NCT04542473|Drug|Ursodeoxycholic acid|Ursodiol C24H40O4 suspension
15788796|NCT04542460|Procedure|PCI|"A loop recorder is implanted i all patients in both study groups to investigate:
~Prevalence and severity of cardiac arrhythmias.
~Effect on detected arrhythmia, in particular ventricular tachyarrhythmia, of optimal medical therapy vs. coronary revascularization by PCI.
~Prevalence and severity of cardiac arrhythmias in CTO-patients with failed PCI.
~Indication for prophylactic ICD implantation in CTO-patients treated conservatively or by PCI and after failed PCI.
~Relation of arrhythmias to angina pectoris symptoms (CCS class), Quality of life questionnaire results and presence of myocardial reversible perfusion defects by CMRI."
15788797|NCT04542447|Drug|Nuvastatic|Polymolecular botanical standardized extract Orthosiphon stamineus/Orthosiphon aristatas as an immunomodulator adjuvant therapy
15788800|NCT04542421|Diagnostic Test|Lung ultrasound use in patients hospitalized with COVID|Hospitalists will be taught to use lung ultrasound in the management of their patients with COVID
15788801|NCT04542408|Drug|Anticoagulation Agents (Edoxaban and/or high dose LMWH)|In-hospital (ICU & normal ward): weight-adapted LMWH, high dose/ therapeutic dose (according to respective SmPC) After discharge and in ambulatory patients: Edoxaban according to SmPC until
15788802|NCT04542408|Drug|Low dose Low molecular weight heparin or Placebo|In-hospital (ICU & normal ward): LMWH, prophylactic dose as part of SOC After discharge and in ambulatory patients: Administration of oral pla-cebo according to the dosing rules for Edoxaban
15788803|NCT04542395|Behavioral|Increasing Willingness and Uptake of COVID-19 Testing and Vaccination|Provide/enhance knowledge, modify attitudes, motivate and provide skills and resources to reduce COVID-19 related risk and challenges and increase willingness and uptake in COVID-19 testing and vaccination.
15788804|NCT04542382|Drug|Rosuvastatin|"Rosuvastatin will be administered as follows:
~Day 1: single dose of 10 mg Rosuvastatin tablet."
15788805|NCT04542382|Drug|Rosuvastatin (Inhibitor arm)|"Rosuvastatin will be administered as follows:
~Day 8: single dose of 10 mg Rosuvastatin tablet."
15788806|NCT04542382|Drug|Eltrombopag|"Eltrombopag will be administered as follows:
~Day 8: single dose of 75 mg Eltrombopag tablet."
15788807|NCT04542369|Drug|BGB-A317 Plus Chemotherapy (Cisplatin and Etoposide)|Inductive/neoadjuvant therapy: BGB-A317 + EP Maintenance/adjuvant therapy: BGB-A317
15788808|NCT04542356|Drug|PEG-rhG-CSF|During the concurrent chemoradiotherapy, a single subcutaneous injection of 6 mg PEG-rhG-CSF was given to the patient 2 hours after radiotherapy on the first day after the end of chemotherapy. Blood tests were performed weekly, if the patient's neutrophils were less than 1.0 × 109 / L during radiotherapy, rhG-CSF was given as a remedial treatment. If fever occurs, antibiotics were given promptly.
15788809|NCT04542356|Drug|rhG-CSF|Blood tests were performed weekly, if the patient's neutrophils were less than 1.0 × 109 / L during radiotherapy, rhG-CSF was given as a remedial treatment. If fever occurs, antibiotics were given promptly.
15788810|NCT04542343|Behavioral|Change in knowledge, motivation, skills, resources|Provide/enhance knowledge, modify attitudes, motivate and provide skills and resources to reduce COVID-19 related risk and challenges.
15788811|NCT04542330|Biological|BCG-Denmark|Mycobacterium bovis BCG live attenuated BCG-Denmark vaccine (AJ Vaccines, Copenhagen, Denmark) administered by intradermal injection in the left deltoid region.
15788812|NCT04542330|Biological|Saline|Participants randomized to the control group will receive one 0.1 ml dose sterile 0.9 % NaCl by intradermal injection in the left deltoid region.
15788815|NCT04542304|Drug|Metolazone|Participants will be given a metolazone for the 1-week study period.
15788816|NCT04542304|Drug|Placebo|Participants will be given a placebo for the 1-week study period.
15788817|NCT04542291|Drug|Dapagliflozin|Dapagliflozin will be provided for this trial
15788818|NCT04542291|Device|BIOSENSE meters|-Being used in this trial to evaluate utility for assessing breath ketones
15788819|NCT04542278|Drug|Prednisone|used to reduce inflammation
15788820|NCT04542265|Combination Product|Effects of Oat and Oat Components on Cardiometabolic risk variables|Oat and oat bioactive components consumed as breakfast meal.
15788821|NCT04542252|Drug|SyB V-1901|SyB V-1901 10 mg via IV infusion for 2 hours
15788822|NCT04542252|Drug|Cyclosporine|200 mg Capsule
15788823|NCT04542226|Drug|Polyoxidonium|Polyoxidonium (azoximer bromide) is administered in the dose of 12 mg (contents of 2 vials) once daily intravenously (IV) for 3 days, then every other day intramuscularly (IM) on days 5-17 (the total treatment course is 10 injections)
15788824|NCT04542213|Drug|Linagliptin tablet|Linagliptin 5mg once daily plus a basal-bolus insulin scheme
15788825|NCT04542213|Drug|Insulin|Basal-bolus insulin scheme
15788826|NCT04542200|Biological|Antibody testing|The antibody results include understanding modifications from environments at work and the community.
15788827|NCT04542161|Drug|NAC 900mg/day|self administer NAC 900mg/day caplets for a four week period
15788828|NCT04542161|Drug|NAC 3600mg/day|self administer NAC 3600mg/day caplets for a four week period
15788829|NCT04542161|Drug|NAC 0mg/day (Placebo)|self administer NAC 0mg/day (placebo) caplets for a four week period
15788834|NCT04542135|Drug|Sulindac Pill|Randomized participants will receive either 150 mg oral sulindac twice daily.
15788835|NCT04542135|Drug|Placebo|placebo pills twice daily
15788836|NCT04542122|Behavioral|Choices and judgements|In the intervention arm, the participant is asked to answer clinical cases in a reverse order from the control group (control has to make moral choices then judge somebody else's choices ; intervention has to judge moral choices first, then make his own)
15788837|NCT04542109|Behavioral|READyR A|Two active sessions to conduct an individually-tailored dementia-related needs assessment, incorporating the participant's care values and objective data from remote in-home monitoring.
15788839|NCT04542096|Device|Lung electrical impedance tomography monitoring|A belt for recording changes in electrical impedance in the skin will be fastened for the purpose of this study with no other additional procedures
15788840|NCT04542070|Drug|Cabotegravir Tablets|CAB tablets will be available as white to almost white oval shaped film coated tablets of 30 mg for oral administration.
15788841|NCT04542070|Drug|Cabotegravir Injectable Suspension (CAB LA)|CAB LA will be available as sterile white to slightly pink suspension for injection in 200 mg/milliliters (mL) of GSK1265744 for administration as IM injection.
15788842|NCT04542070|Drug|Rilpivirine Tablets|RPV tablets will be available as off-white, round, biconvex, film-coated tablets of 25 mg for oral administration. Each tablet contains 27.5 mg of Rilpivirine hydrochloride, which is equivalent to 25 mg of RPV.
15788843|NCT04542070|Drug|Rilpivirine Injectable Suspension (RPV LA)|RPV LA will be available as a sterile white suspension containing 300 mg/mL of RPV to be administered as an IM injection.
15788844|NCT04542070|Drug|BIKTARVY Tablets (BIK)|BIK will be available as purplish brown, capsule-shaped, film-coated tablet. It will be a three-drug fixed dose combination product containing 50 mg of BIC, 200 mg of FTC, and 25 mg of TAF for oral administration.
15788845|NCT04542057|Drug|Ensifentrine|"Dosage Formulation:
~Ensifentrine Nebulizer suspension Dosage 3mg Frequency: Twice Daily 24-week study that will enroll 800 patients and be randomized 5:3 to ensifentrine (3 mg): placebo"
15788846|NCT04542057|Drug|Placebo|"Dosage Formulation:
~Ensifentrine Nebulizer suspension Dosage 3mg Frequency: Twice Daily 24-week study that will enroll 800 patients and be randomized 5:3 to ensifentrine (3 mg): placebo"
15788847|NCT04542044|Other|management strategy of outpatient with mild to moderate SARS-CoV-2 pneumonia|Data collected with a cohorte of SARS-CoV-2 pneumonia in an outpatient basis
15788848|NCT04542031|Other|Questionnaire|Questionnaire to be completed at 6 and 12 months
15788849|NCT04542018|Other|a low FODMAP diet for 4 weeks|low FODMAP diet for 4 weeks
15788850|NCT04542005|Behavioral|q3h albuterol|Using q3h albuterol as discharge criteria from hospital
15788851|NCT04541979|Drug|aerosolized DNase|DNase
15788852|NCT04541979|Drug|NaCl|NaCl 0.9%, isotonic saline
15788853|NCT04541953|Other|Telerehabilitation Therapy|Rehabilitation services will be dispensed at patients' home utilizing video telecommunication services with real-time synchronous exchange of information - range of motion exercises and stretching.
15788854|NCT04541953|Other|In-person Rehabilitation Therapy|Range of motion exercises and stretching
15788855|NCT04541940|Other|Telerehabilitation Therapy|Rehabilitation services will be dispensed at patients' home utilizing video telecommunication services with real-time synchronous exchange of information - Quadriceps isometrics exercises, straight leg raises, and range of motion exercises.
15788856|NCT04541940|Other|In-person Rehabilitation Therapy|Quadriceps isometrics exercises, straight leg raises, and range of motion exercises.
15788857|NCT04541927|Genetic|Epigenetic signatures|Epigenetic signatures (Dr Sadikovic' lab, London, Ontario, Canada)
15788858|NCT04541914|Diagnostic Test|5-gene classification model|Peripheral blood marker-based molecular diagnostic method for AMR in ABOiKT
15788859|NCT04541901|Other|Deep massage|The intervention group will receive 12 minutes of massage on the legs, arms and the back with three different sliding pressures.
15788860|NCT04541901|Other|Superficial Massage|The comparator group will receive 12 minutes of only one sliding pressure The superficial massage will be performed on the legs, arms and the back.
15788861|NCT04541901|Other|Cold water immersion|The intervention group will receive 12 minutes of cold water immersion at 14±1°C and shoulder level.
15788862|NCT04541901|Other|Water immersion in room temperature|The comparator group will receive 12 minutes of water immersion at 27±1°C and shoulder level.
15788863|NCT04541888|Drug|CsA Ophthalmic Gel|The CsA eye gel of 0.3 g: 0.15 mg
15788864|NCT04541888|Drug|Placebo|Placebo
15788865|NCT04541888|Drug|Hypromellose Eye Drop|Hypromellose Eye Drops of 10ml：50mg, 3 times daily, 1-2 drop
15788866|NCT04541875|Other|MAR-Scale|The MAR-Scale is a 20-item questionnaire based on commonly reported reasons for non-adherence to medications.
15788867|NCT04541862|Other|Intensive care|intensive care for critically ill patients in the intensive care units
15788868|NCT04541849|Other|Critical Care|Critical care in the intensive care units
15788869|NCT04541836|Diagnostic Test|18F-PMPBB3|single intravenous injection 5mCi 18F-PMPBB3 per scan
15788870|NCT04541823|Drug|Desﬂurane|Investigators administrated desflurane with target of BIS 40-60 during the maintenance of anesthesia
15788871|NCT04541823|Drug|Propofol|Investigators administrated propofol with target of BIS 40-60 during the maintenance of anesthesia
15788872|NCT04541797|Drug|Empagliflozin 10 MG|Intervention group: Patients will be prescribed empagliflozin 10mg once a day and optimised medical therapy for 6 months and standard follow-up like the control group.
15788873|NCT04541797|Drug|Placebo|Control group: Patients will have placebo and optimised medical therapy and will continue to have protocol driven therapy and follow-up appointments (currently 1 appointment every 3 months).
15788874|NCT04541797|Diagnostic Test|Stress Cardiac Magnetic Resonance|Imaging: All patients will have stress CMR examinations at recruitment.
15788875|NCT04541784|Other|WOMAN-PRO III|"Standardized care and three counselling sessions with a gynaecology-oncology nurse and the use of the mobile app WOMAN-PRO III."
15788876|NCT04541784|Other|Three counselling sessions with gynaecology-oncology nurses|Standardized care, three counselling sessions with a gynaecology-oncology nurse.
15788877|NCT04541771|Drug|Lactobacillus Reuteri DSM 17938|The trial group will receive their usual feeds plus daily probiotic addition 1 drop/kg/dose twice daily added in expressed breast milk/formula milk from the beginning of enteral feedings till the baby attain full feeds
15788878|NCT04541771|Drug|Placebo|expressed breast milk/formula milk plus normal saline drop from the beginning of enteral feedings till the baby attain full feeds
15788879|NCT04541758|Procedure|surgical treatment|surgical treatment and Conservative treatment
15788880|NCT04541758|Procedure|Conservative treatment|Conservative treatment
15788937|NCT04541303|Drug|Tranexamic acid|tranexamic acid diluted to concentration of 25ml/mg
15788938|NCT04541303|Drug|normal saline|0.9% sodium chloride
15788939|NCT04541290|Drug|Protopic 0.1 % Topical Ointment|Applied in a thin layer covering all of the arm including the armpit and hand once a day for six months
15788881|NCT04541732|Other|Thoracic epidural block|Patients who will be subjected to epidural block will be placed in the lateral position then, after sterilization of the skin, 21 G spinal needle will be inserted at T9-T11 intervertebral spaces. The epidural space will be located using the loss of resistance to air technique and a mixture of bupivacaine 0.25% + 50 μ fentanyl targeting T6 level will be injected following induction of general anaesthesia.
15788882|NCT04541732|Other|Ultrasound-guided bilateral quadratus lumborum block|Patients who will be subjected to major abdominal surgeries will be placed in a supine position with a pillow under their side to obtain an appropriate view of quadratus lumborum muscle. After sterilization of the skin and ultrasound-guided identification of the quadratus lumborum muscle, 20 ml bupivacaine 0.25% + 25μ fentanyl will be injected on each side following induction of general anaesthesia
15788883|NCT04541732|Drug|Induction of general anaesthesia with propofol|propofol: 1.5-2.5mg/Kg
15788884|NCT04541732|Drug|Muscle Relaxant|Atracurium : 0.5mg/Kg.
15788885|NCT04541732|Drug|Maintenance of general anaesthesia|Sevoflurane 0.7-1.5 MAC in 40% oxygen
15788886|NCT04541719|Drug|Patient-controlled remifentanil analgesia|Patient controlled remifentanil analgesia with a regimen to provide a bolus of 40 μg remifentanil with a lockout interval of 2 min
15788887|NCT04541719|Drug|Epidural analgesia|Patients will receive continuous epidural analgesia using bupivacaine 0.125% in conjunction with fentanyl 2 ug/ml at a rate of 8-15 ml/hr
15788888|NCT04541706|Drug|Lorlatinib|Lorlatinib will be supplied for oral administration as 25 mg tablets. The recommended dosage of lorlatinib is 100 mg orally once daily.
15788889|NCT04541693|Device|Full revision|Both cup and stem require revision
15788890|NCT04541693|Device|Cup revision|Only the cup requires revision
15788891|NCT04541693|Device|Stem revision|Only the stem requires revision
15788892|NCT04541680|Drug|Nintedanib 150 MG [Ofev]|Experimental group will receive nintedanib 150mg BID for 12 months in addition to standard of care (SoC). Nintedanib dose could be reduced to 100mg BID depending on tolerance according to investigator in charge of the patient. The prescription of SoC drugs or procedure will be let to the choice of the investigator in charge of the patient.
15788893|NCT04541680|Other|Placebo|Placebo
15788894|NCT04541667|Drug|Air|Air will be used for luminal inflation.
15788895|NCT04541667|Drug|Carbon Dioxide|Carbon dioxide will be used for luminal inflation.
15788896|NCT04541654|Genetic|Data and Specimen Collection|"Provide research team and access to relevant medical records
~Answer short questionnaires periodically
~Consider consenting to other optional parts of the research such as:
~Providing up to 3 tubes (15ml) of blood at or near the time of consent, as approved by treating physician (optional).
~Provide a saliva sample (optional).
~Provide eyebrow hairs for analysis of DNA from the bulb (15-20 eyebrow plucks) (optional).
~Provide permission for obtainment of stored tissue specimens from cancer or pre-cancer surgeries or biopsies from the pathology departments where they have been stored (optional).
~Consider inviting relatives to join the study (optional)."
15788897|NCT04541641|Procedure|New Reverse Drilling technique|a new technique of dental implant drilling that promote osseodensification by rotating the drills anti-clockwise rather than clockwise to promote bone condensation rather than bone cutting
15788898|NCT04541641|Procedure|osteotome technique|a technique for dental implant placement by using the osteotome to condense the bone and create an osteotome rather than cutting the bone
15788899|NCT04541628|Combination Product|SIG-001|Laparoscopic administration of SIG-001 spheres, an encapsulated allogeneic cell therapy genetically modified with a non-viral vector to produce BDD-hFVIII.
15788900|NCT04541615|Procedure|Online course with proficiency test|Participants will receive an online e-course with a proficiency test at the end. Afterwards, participants will have to perform a hermetic circular anastomosis that allows connecting two anatomical tubular structures using an outside-inside direction in the stomach and inside-outside in the cloaca. Two hemi-continuous sutures must be performed, knotting the two treads at the end.
15788901|NCT04541615|Procedure|Online course|Participants will receive an online e-course but are not required to pass the proficiency test. Afterwards, participants will have to perform a hermetic circular anastomosis that allows connecting two anatomical tubular structures using an outside-inside direction in the stomach and inside-outside in the cloaca. Two hemi-continuous sutures must be performed, knotting the two treads at the end.
15788902|NCT04541615|Procedure|Standard training group|After receiving a traditional lecture, participants will have to perform a hermetic circular anastomosis that allows connecting two anatomical tubular structures using an outside-inside direction in the stomach and inside-outside in the cloaca. Two hemi-continuous sutures must be performed, knotting the two treads at the end.
15788903|NCT04541615|Procedure|Apprenticeship group|Participants will have to perform a hermetic circular anastomosis that allows connecting two anatomical tubular structures using an outside-inside direction in the stomach and inside-outside in the cloaca. Two hemi-continuous sutures must be performed, knotting the two treads at the end. Participants will only receive papers on how the task will be performed and clinicians will help them with completion of the task.
15788904|NCT04541589|Drug|CFZ533 (iscalimab)|Biological
15788905|NCT04541589|Other|CFZ533 Placebo|Matching placebo
15788906|NCT04541576|Device|Merit WRAPSODY Endovascular Stent Graft|Target lesion treated with stent graft placement
15788907|NCT04541563|Device|Fisher Wallace Cranial Electrotherapy Stimulator Device|Fisher Wallace Stimulator®, a patented cranial electrotherapy stimulation device that was cleared by the FDA in 1991 for the treatment of depression, anxiety and insomnia.
15788908|NCT04541550|Drug|AMP-001 Low Dose|AMP-001, is manufactured from the amniotic membrane of the placenta and does not contain living cells.
15788909|NCT04541550|Drug|AMP-001 Medium Dose|AMP-001, is manufactured from the amniotic membrane of the placenta and does not contain living cells.
15788910|NCT04541550|Drug|AMP-001 High Dose|AMP-001, is manufactured from the amniotic membrane of the placenta and does not contain living cells.
15788911|NCT04541537|Diagnostic Test|Sorbstar®|Thermodesorption method coupled with full two-dimensional gas chromatography and mass spectrometry
15788912|NCT04541537|Diagnostic Test|Dog Detection|Analysed by the dogs of Curie Institute at the training centers
15788940|NCT04541277|Drug|Tislelizumab|Tislelizumab combined with DNA demethylation agent +/- CAG regimen
15789110|NCT04540107|Procedure|Magnetic Resonance Spectroscopic Imaging|Undergo MRSI
15790692|NCT04527458|Other|Patient Characteristics|Characteristics of the patients
15788913|NCT04541524|Device|Santen Preserflo Microshunt|The PMS is 8.5 mm long has an outer diameter of 350 μm and a lumen diameter of 70 μm. It has a fin sized 1.1 mm located 4.5 mm distally from the internal tip of the device and it consists of poly(styrene-b-isobutylene-b-styrene) SIBS. The device was implanted 1 year prior to the present study via an ab externo approach. At the beginning of the surgery, the conjunctiva was opened. In the first group of patients (group 1) we made a fornix based conjunctival opening, prepared a 1mm wide and long scleral pocket in 3mm distance from limbus and placed the PMS in the anterior chamber via a 25G needle track. In the second group (group 2) the conjunctival opening was 3.5 mm from the limbus, the scleral pocket was prepared at 3.5 mm distance from the limbus and a 27G needle was used. PMS guides aqueous humor from the anterior chamber to the subconjunctival space. The forming filtering bleb absorbs aqueous humor which leads to IOP reduction.
15788914|NCT04541511|Diagnostic Test|6-minutes walking test on a corridor|6-minutes walking test on a corridor : patient will be asked to achieve the longest possible distance without running. He/she will be allowed to take breaks if he/she feels the need to do so.
15788915|NCT04541511|Diagnostic Test|6-minutes walking test on a treadmill|6-minutes walking test on a treadmill : patient will be asked to achieve the longest possible distance without running on the treadmill. He/she will be allowed to take breaks if he/she feels the need to do so.
15788916|NCT04541498|Other|Impact of air pollution and climate changes|To assess the short- and long- term impact of air pollution and climate changes
15788917|NCT04541485|Drug|DWRX2003|Intramuscularly injection at pre-defined injection sites
15788918|NCT04541485|Drug|Placebo|Intramuscularly injection at pre-defined injection sites
15788919|NCT04541459|Device|new device against ambient electromagnetic radiation|New device provides protection against the radiations emitted by the smartphone and laptop devices. Device uses conductive fluids in a particular geometric arrangement intended to ameliorate the negative effects of EMW radiation.
15788920|NCT04541459|Device|sham device against ambient electromagnetic radiation|Sham device as as a control for new device, which provides protection against the radiations emitted by the smartphone and laptop devices. Device uses conductive fluids in a particular geometric arrangement intended to ameliorate the negative effects of EMW radiation.
15788921|NCT04541446|Other|Dynamic Haptic Robotic Trainer (DHRT)|Device trains medical residents to safely perform the needle insertion portion of Central Venous Catheterization.
15788922|NCT04541446|Other|Advanced Dynamic Haptic Robotic Trainer (DHRT+)|Device offers whole procedural training for medical residents to safely perform the procedure of Central Venous Catheterization.
15788923|NCT04541433|Drug|AZD9833|AZD9833 taken orally
15788924|NCT04541407|Drug|Temozolomide plus Osimertinib|Temozolomide is an oral alkylating chemotherapy which has good CNS penetration and has demonstrated CNS responses in both primary brain tumors (e.g., glioblastoma and anaplastic astrocytoma) and in small cell lung cancer (SCLC) brain metastases. Preclinical data from glioblastoma suggests potential synergy of concurrent ALK or EGFR inhibition with temozolomide and early phase trials in glioblastoma are ongoing investigating such combinations. It is felt that combining temozolomide with osimertinib or lorlatinib may be beneficial for patients with progressive CNS disease on either of these TKIs because of the high CNS penetration of temozolomide, good CNS activity of temozolomide in other tumor types and preclinical data from glioblastoma suggesting a potential enhanced effect of concurrent EGFR and ALK/ROS1 inhibition with temozolomide.
15788925|NCT04541407|Drug|Temozolomide plus Lorlatinib|Temozolomide is an oral alkylating chemotherapy which has good CNS penetration and has demonstrated CNS responses in both primary brain tumors (e.g., glioblastoma and anaplastic astrocytoma) and in small cell lung cancer (SCLC) brain metastases. Preclinical data from glioblastoma suggests potential synergy of concurrent ALK or EGFR inhibition with temozolomide and early phase trials in glioblastoma are ongoing investigating such combinations. It is felt that combining temozolomide with osimertinib or lorlatinib may be beneficial for patients with progressive CNS disease on either of these TKIs because of the high CNS penetration of temozolomide, good CNS activity of temozolomide in other tumor types and preclinical data from glioblastoma suggesting a potential enhanced effect of concurrent EGFR and ALK/ROS1 inhibition with temozolomide
15788926|NCT04541394|Device|MolecuLight|MolecuLight is a device that utilizes a special light which, when used on wounds, helps identify the regions which pathogenic bacterial counts are the highest. The device applies 405nm violet light which is harmless to the human tissue. When specific components in bacteria catches up the light, a photoluminescent reaction is triggered and the fluorescence light is caught by the camera on this device in real time.
15788927|NCT04541381|Other|Pharmacogenomics (PGx) Testing and Genomics Prescribing Information (GPS)|A genotyping test and prescribing system designed to provide participant-specific dosing information to cancer care providers based on the participant's unique genetics/genomics.
15788928|NCT04541368|Drug|CS1 Targeted CAR T-cells|Each subject receive CS1 Targeted CAR T-cells by intravenous infusion
15788929|NCT04541355|Drug|Cisplatin|Given IV
15788930|NCT04541355|Other|Hearing Handicap Inventory for Adults - Screening|Patient self-assessment questionnaire to measure probability of hearing impairment
15788931|NCT04541355|Radiation|Radiation Therapy|Radiation therapy will be delivered according to the standard of care
15788932|NCT04541355|Drug|Sodium Thiosulfate|Given IV
15788933|NCT04541355|Diagnostic Test|Questionnaire based on Patient Reported Outcomes-Criteria for Adverse Events (PRO-CTCAE) (PRO-CTCAE)|Selected oral, GI, neurologic and perceptual symptoms are reported by patient
15788934|NCT04541342|Procedure|initial arthroscopy with medial opening-wedge high tibial osteotomy fixed by a plate system then second look arthroscopy with plate removal|It is a joint preserving procedure especially preferred in young patients for whom arthroplasty is not desirable. The procedure promotes regeneration by causing lateral shift of the weight-bearing axis, thus decreasing load on the medial compartment and widening the medial joint space.Many of the patients complains of irritation through the plate and wish metal removal after healing of the osteotomy.All patients will undergo initial arthroscopy before high tibial osteotomy (HTO). During arthroscopy, debridement of the degenerate tissues and meniscal tears if present will be performed. Then opening-wedge high tibial osteotomy (OWHTO) will be performed and fixed by a plate system. Second-look arthroscopy will be conducted at the time of plate removal after healing of the osteotomy. This will be after about 6 months up to one year.
15788935|NCT04541329|Biological|Tildrakizumab|IL-23 inhibitor
15788936|NCT04541316|Device|ProFlor inguinal hernia device|Inguinal hernia repair
15788941|NCT04541264|Diagnostic Test|radiomic of chest CT|radiomics as a quantitative imaging method for early detection, risk assessment, and treatment decisions for early predicting sepsis induced acute respiratory distress syndrome.
15788942|NCT04541251|Drug|Camrelizumab + Nab-paclitaxel + Carboplatin|The patients will receive three cycles (one cycle is defined as every 21 days +/- 3 days) of neoadjuvant therapy with camrelizumab 200 mg, nab-paclitaxel 260 mg/m2, and carboplatin AUC 5. This will then be followed by surgery.
15788943|NCT04541238|Diagnostic Test|MRI|Magnetic resonance imaging
15788944|NCT04541225|Drug|NUV-422|NUV-422
15788947|NCT04541199|Device|closed loop|RR and VT will be selected according to the respiratory mechanics by closed loop algorithm
15788948|NCT04541199|Device|conventional|RR, VT, Ti will be selected by the clinician according to the respiratory mechanics
15788949|NCT04541186|Drug|BIO89-100|BIO89-100
15788950|NCT04541186|Drug|Placebo|Placebo
15788951|NCT04541173|Other|Y-90 TARE|"This plan will involve treating the predominant liver lesions with segment Y-90 TARE using predetermined dosimetry, while keeping FLR equal or greater than 40% (FLR is estimated by excluding the liver volume of Y-90 infused distribution).
~The maximal amount of Y-90 TARE treatment will be limited to only one lobe of the liver if segmental Y-90 TARE is not possible to treat the predominant lesion. Since segmental Y-90 TARE may result in less long term liver damage compared to lobal Y-90 TARE, segmental Y-90 TARE treatment is preferred to lobar Y-90 TARE if segmental Y-90 TARE treatment is able to treat all blood supply to the predominant lesion or lesion with vascular invasion to preserve liver function. For segmental treatment, a minimum tumor dose of 190 Gy should be used for glass microspheres and 120 Gy for resin microspheres. For lobar treatment, a minimum dose of 100 Gy should be used for resin microspheres."
15788952|NCT04541173|Drug|Atezolizumab|Atezolizumab 1200 mg will be delivered as an IV infusion on Day 1 of each cycle (every 3 weeks). The initial dose will be delivered over 60 (± 15) minutes and if tolerated subsequent infusions may be given over 30 minutes.
15788953|NCT04541173|Drug|Bevacizumab|Bevacizumab 15 mg/kg will be delivered as an IV infusion on Day 1 of each 3 week cycle.The initial dose will be delivered over 90 minutes (±15 minutes) and if tolerated subsequent infusions may be given over 60 minutes
15788954|NCT04541160|Diagnostic Test|CR|Lung imaging evaluation performed with CR
15788955|NCT04541160|Diagnostic Test|ULDCT|Lung imaging evaluation performed with ULDCT
15788956|NCT04541147|Drug|Dexamethasone|dexamethasone solution or tablet (depending on age of patient) at 0.5mg/kg/day max of 8mg/day, administered on post-operative days 1,3,5,7.
15788957|NCT04541147|Drug|Analgesics|"standardization of post-operative analgesics (narcotics and non-narcotic medication).
~Oxycodone solution or tablet (depending on age of patient) at 0.05-0.1 mg/kg/dose every 6hrs; max 5mg (obese/OSA); prescribe 30 doses
~Acetaminophen 10-15 mg/kg/dose every 6 hours; max 500mg per dose; prescribe 56 doses (over the counter medication)
~Ibuprofen 5-10 mg/kg/dose every 6 hours; max 200 mg/dose; prescribe 56 doses (over the counter medication)"
15788958|NCT04541134|Drug|Pelubiprofen 45mg|Pelubiprofen 45mg 1 tab for moderate or severe menstrual pain, bid for 3days(prn)
15788959|NCT04541134|Drug|Placebo|Placebo1 tab for moderate or severe menstrual pain, bid for 3days(prn)
15788960|NCT04541121|Behavioral|3D printed model|Mother is given 3D printed model of fetus' face
15788961|NCT04541121|Behavioral|Placebo|Mother is given a picture of 3D ultrasound of fetus
15788962|NCT04541108|Drug|BMS-986299|Intratumoral microdose injection by the CIVO device.
15788963|NCT04541108|Biological|Relatlimab|Intratumoral microdose injection by the CIVO device.
15788964|NCT04541108|Biological|Ipilimumab|Intratumoral microdose injection by the CIVO device.
15788965|NCT04541108|Biological|Nivolumab|Intratumoral microdose injection by the CIVO device.
15788966|NCT04541108|Combination Product|Ipilimumab + Nivolumab|Intratumoral microdose injection by the CIVO device.
15788967|NCT04541108|Combination Product|Relatlimab + Nivolumab|Intratumoral microdose injection by the CIVO device.
15788968|NCT04541108|Combination Product|BMS-986299 + Nivolumab|Intratumoral microdose injection by the CIVO device.
15788969|NCT04541108|Drug|TAK-676|Intratumoral microdose injection by the CIVO device.
15788970|NCT04541108|Drug|Carboplatin|Intratumoral microdose injection by the CIVO device.
15788971|NCT04541108|Drug|5-FU|Intratumoral microdose injection by the CIVO device.
15788972|NCT04541108|Drug|Paclitaxel|Intratumoral microdose injection by the CIVO device.
15788973|NCT04541108|Combination Product|TAK-676 + Carboplatin|Intratumoral microdose injection by the CIVO device.
15788974|NCT04541108|Combination Product|Carboplatin + Paclitaxel|Intratumoral microdose injection by the CIVO device.
15788975|NCT04541108|Combination Product|Carboplatin + 5-FU|Intratumoral microdose injection by the CIVO device.
15788976|NCT04541108|Combination Product|TAK-676 + Carboplatin + 5-FU|Intratumoral microdose injection by the CIVO device.
15788977|NCT04541108|Combination Product|TAK-676 + Carboplatin + Paclitaxel|Intratumoral microdose injection by the CIVO device.
15788978|NCT04541108|Biological|Pembrolizumab|Intratumoral microdose injection by the CIVO device.
15788979|NCT04541108|Combination Product|MK-0482 + Pembrolizumab|Intratumoral microdose injection by the CIVO device.
15788980|NCT04541108|Combination Product|MK-4830 + Pembrolizumab|Intratumoral microdose injection by the CIVO device.
15788981|NCT04541095|Other|EX_IMF|Infant formula with large amounts of beta-palmitate (about 60%).
15788982|NCT04541095|Other|ST_IMF|Infant formula with low amounts beta-palmitate (about 10%).
15788983|NCT04541082|Drug|ONC206|ONC206 is a member of the imipridone class of anti-cancer small molecules that share a unique tri-heterocyclic core chemical structure and target G protein-coupled receptors
15788984|NCT04541069|Behavioral|Social Communication and Emotional Skill Development (SCESD) module|The intervention, Social Communication and Emotional Skill Development (SCESD) module, is based on the basics of the neuroscience of child development. The module has focused on these basic behaviors of infants, and has incorporated strategies to enhance the five basic behaviors i.e. eye contact, attention to others, joint attention, imitation and non-verbal communication.
15788985|NCT04541056|Behavioral|Goal Management Training (GMT)|The manual comprises an introduction to GMT for the survivors of ALL, and a detailed session structure incorporating cognitive and behavioral tasks. The GMT program involves teaching the participants about goals, attention slips and how to manage these, how to review and prioritize goals (e.g., Stop, Think, Organize, Plan), and how to keep goals in mind (e.g., using analogies such as the mental blackboard). Each session will follow the same general format; namely, facility-delivered presentations, flipchart discussions, group activities and homework.
15788986|NCT04541056|Behavioral|Brain Health Workshop (BHW)|BHW is a psycho-educative control condition, and is typically part of psycho-educative Acquired Brain Injury (ABI) rehabilitation programs, but adjusted for the ALL group of participants. The psycho-educative control condition BHW will be matched GMT for amount of training and therapist contact. Homework assignment and in-session tasks included readings, brain games, puzzles, and practical exercises such as logging sleep.
15788987|NCT04541043|Drug|Nefecon|Nefecon is taken orally as capsules once daily in the morning for 9 months.
15788988|NCT04541017|Biological|Magrolimab|Given IV
15788989|NCT04541017|Biological|Mogamulizumab|Given IV
15788990|NCT04541004|Biological|HDM SLIT-tablet|Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)
15788991|NCT04540991|Procedure|implant placement|The implants are placed in accordance with each implant system manufacturer's instructions and the treatment were performed according to the patient's standards and indications. Surgical procedures on all patients are performed by the same operator with the same surgical approach, protocol and instrumentation.
15788992|NCT04540991|Procedure|gingiva former placement|Gingiva former are placed in accordance with each implant system manufacturer's instructions and the treatment were performed according to the patient's standards and indications. Surgical procedures of oppeninf implant cower and gingiva former placement on all patients are performed by the same operator with the same surgical approach, protocol and instrumentation.
15788993|NCT04540991|Diagnostic Test|Collecting gingival epithelial cellsusing the swab technique|Samples of gingival epithelial cells are collected from each participant's implementation site using the swab technique at three different time points: a control swab is taken just before the placement of the dental implant (T0); the second swab is taken 90 days after implantation meaning immediately before placement of the gingiva former (T1); and the third swab is taken 21 days after placement of the gingiva former (T2).
15788994|NCT04540965|Drug|Telaglenastat|Glutaminase inhibitor
15788995|NCT04540965|Drug|Famotidine|Histamine-H2 Receptor Antagonist
15788996|NCT04540965|Drug|Placebo for famotidine|Placebo for Histamine-H2 Receptor Antagonist
15788997|NCT04540952|Device|Total Capture Drape|Surgical drape created by Principal Investigator to adequately collect fluid during hysteroscopy procedure
15788998|NCT04540952|Device|Standard Hysteroscopy Drape|Standard surgical drape used to adequately collect fluid during hysteroscopy procedure
15788999|NCT04540939|Behavioral|Mindfulness-Based Cognitive Therapy|"There will be 8 sessions and these will be approximately 2 hours long. Over the 8-weeks participants will learn several mindfulness meditation techniques. Each session will involve group discussion and feedback. Participants will be asked to practice these techniques at home, and keep a log of mood, and stress ratings.
~Audio files with exercises will be given to participants so that they can practice at home between sessions."
15789000|NCT04540939|Behavioral|Muscle Relaxation Therapy|Each MR session is approximately 2 hours. Over the 8-weeks you will learn how to relax your body using a step-by-step process in which you alternate between squeezing and relaxing your muscles. You will learn about your body's natural response to stress and how to use muscle relaxation during your everyday life. Each session will also involve group discussion and feedback. You will be asked to practice these techniques at home, and keep a log of your mood, and stress ratings. You will receive audio files with exercises so you can practice at home between sessions.
15789001|NCT04540926|Drug|Cyclosporin A|COVID-19 pneumonia patients treated with oral CsA at a dose of 1-2 mg /kg / day divided into two doses, for 7 days, since entering to hospitalization.
15789002|NCT04540900|Biological|KB301|non-integrating HSV-1 vector expressing human type III collagen injection
15789003|NCT04540900|Other|Placebo|sterile isotonic saline injection
15789004|NCT04540887|Device|Pulsed Electromagnetic Field (PEMF) Therapy|PEMF therapy will be self-administered by all trial participants using the B. Body, B. Pad, and Control Unit. Participants will administer this therapy twice a day (morning and evening) for 8-minute sessions over a four week period.
15789005|NCT04540874|Drug|BI 894416|BI 894416
15789006|NCT04540874|Drug|Placebo|Placebo
15789007|NCT04540861|Drug|Siponimod|1 or 2 mg film-coated tablets. The tablets have to be taken orally once daily and swallowed whole with water, with or without food.
15789011|NCT04540835|Drug|Calcium phosphate desensitizer|Calcium phosphate containing desensitizing agent that creates hydroxyappatite
15789100|NCT04540172|Behavioral|Music Therapy|"Mahur tune, one of the nonverbal instruments of the Traditional Turkish Music Authorities, was selected for the study with the opinion of a music therapy specialist."
15789101|NCT04540172|Behavioral|Progressive Muscle Relaxation Exercise|"In this study, the steps of applying progressive muscle relaxation exercise were created with the guidance of the Relaxation Exercises  materials of the Turkish Psychological Association."
15789012|NCT04540822|Other|peripheral venous catheter with compress under the catheter-extension tube junction|Placement of a BD Insyte® type catheter of 20 to 24 Gauge calibre on a peripheral vein located in the crease of the elbow or top of the hand or scalp or top of the foot. The catheter is placed while respecting the detersion and disinfection of the skin with the appropriate products and according to the procedure in force in the department. Once the venous return has been checked, a 10 cm extension with a BECTON-DIC® 3-way valve will be connected, which is previously purged with 0.9% Sodium Chloride. Under the catheter-extension tube junction will be inserted a sterile non-woven compress, cut sterilely (3.5x1.5 cm). The assembly will be held in place by a transparent sterile semi-permeable adhesive dressing such as Tegaderm® (5x7 cm). This area will be secured by placing a crepe bandage (crepe bandage 4 m x7 cm).
15789013|NCT04540822|Other|peripheral venous catheter without compress under the catheter-extension tube junction|Placement of a BD Insyte® type catheter of 20 to 24 Gauge calibre on a peripheral vein located in the crease of the elbow or top of the hand or scalp or top of the foot. The catheter is placed while respecting the detersion and disinfection of the skin with the appropriate products and according to the procedure in force in the department. Once the venous return has been checked, a 10 cm extension with a BECTON-DIC® 3-way valve will be connected, which is previously purged with 0.9% Sodium Chloride. No compresses will be inserted under the catheter-extension tube junction.The assembly will be held in place by a transparent sterile semi-permeable adhesive dressing such as Tegaderm® (5x7 cm). This area will be secured by placing a crepe bandage (crepe bandage 4 m x7 cm).
15789014|NCT04540809|Other|Assessment of strength, proprioception, skill and coordination of the hand|Disease Activity Score 28 was used to determine the disease activity of patients with PsA. Grip strength was measured with the help of Baseline Digital Hand Dynamometer®. Pinch strength was measured with Baseline Hydraulic Pinch Gauge®. Wrist proprioception was assessed by measuring the joint position sensation using a goniometer by actively repeating the target angle predetermined by the researcher (30 ° for flexion and extension, 15 ° for ulnar deviation, 10 ° for radial deviation. Finger skills were assessed using a mobile application called Ball Tap©. The application included the fastest contact of the participants to the balls coming from different parts of the screen for 30 seconds. Two hand coordination and skills were evaluated using the Purdue Pegboard test. The Michigan Hand Outcomes Questionnaire was used for functional evaluation of the hand, and the Health Assessment Questionnaire was used to assess the general functional condition and health-related quality of life.
15789015|NCT04540796|Drug|JNJ-75348780|Participants will receive JNJ-75348780 by subcutaneous (SC) administration.
15789016|NCT04540783|Device|Transcranial direct current stimulation (tDCS)|10 sessions of 2mA and 20 minutes tDCS. Sponges size 5x7 cm. For the sham condition, the patient will receive just 30 seconds of stimulation.
15789017|NCT04540770|Drug|HuL001|Anti-ENO1 monoclonal antibody
15789018|NCT04540757|Procedure|Surgery|Participants will be randomised to receive surgery as part of multi-modality treatment
15789019|NCT04540757|Procedure|No surgery|Participants will be randomised to receive no surgery as part of multi-modality treatment
15789020|NCT04540744|Drug|FDC of macitentan/tadalafil (10 mg/20 mg)|FDC of macitentan/tadalafil (10 mg/20 mg) tablet will be administered orally as per assigned treatment sequence.
15789021|NCT04540744|Drug|Macitentan 10 mg|Macitentan 10 mg tablet will be administered orally as a free combination as per assigned treatment sequence.
15789022|NCT04540744|Drug|Tadalafil 20 mg|Tadalafil 20 mg tablet will be administered orally as a free combination as per assigned treatment sequence.
15789023|NCT04540731|Other|This is an observational study without intervention|This is an observational study without intervention
15789024|NCT04540718|Other|Exercise|50 minutes of exercise, consisting of 20 minutes of resistance followed by 30 minutes of aerobic, three times a week for eight weeks.
15789025|NCT04540718|Other|Sauna|15 minutes of sauna exposure immediately after exercise intervention, three times a week for eight weeks.
15789026|NCT04540705|Biological|Nivolumab|Specified dose on specified days
15789027|NCT04540705|Biological|Bempegaldesleukin|Specified dose on specified days
15789028|NCT04540705|Drug|Axitinib|Specified dose on specified days
15789029|NCT04540705|Drug|Cabozantinib|Specified dose on specified days
15789030|NCT04540692|Drug|Docetaxel or Paclitaxel|Treatment will start with Docetaxel 75-100mg/m² intravenously every 21 days for 4 cycles or weekly paclitaxel 80mg/m² for 12 weeks
15789031|NCT04540692|Drug|Cyclophosphamide + Doxorrubicin|Treatment will start with Doxorubicin 60mg/m²; Cyclophosphamide 600mg/m² intravenously every 21 days for 3 cycles
15789032|NCT04540679|Other|VIP4SCI|Technology-enabled self-management & rehabilitation solution
15789033|NCT04540666|Drug|Propofol|Targeted Controlled Propofol Infusion will be set at 1 micro gram/ml.
15789034|NCT04540653|Biological|Standard vaccination schedule|Administer a standard vaccination schedule (three doses of 20 μg of the hepatitis B vaccine, in months 0, 1, 6) at an age of ≥50 years and evaluate a production kinetics after each dose administered in the period of about 30 to 60 days.
15789035|NCT04540653|Biological|Reinforced vaccination schedule|Administer an enhanced vaccination schedule (three doses of 40 μg of the hepatitis B vaccine, in months 0, 1, 6) in individuals aged ≥50 years and assess the kinetics of antibody production after each dose administered in the period of approximately 30 to 60 days.
15789036|NCT04540640|Device|Kidney perfusion pump|The pulsatile perfusion device will circulate room temperature oxygenated perfusion solution through the donor kidney ex vivo.
15789037|NCT04540627|Drug|Palivizumab|Liquid solution in sterile water for injection (final concentration of 20mg/mL), intravenous infusion, single dose of 8mg/kg or 15mg/kg, administered at a rate of 1mL/min
15789038|NCT04540627|Drug|Placebo|Sodium Chloride 0.9% Solution (Normal Saline), intravenous infusion, single dose of 0mg/Kg, administered at a rate of 1mL/min
15789039|NCT04540627|Other|RSV-A Memphis 37b virus|Single Intranasal Virus Dose (challenge dose is approximately 4.5log10 PFU)
15789040|NCT04540614|Other|Strengthening exercises programme|Strengthening exercises for Deep Cervical Flexors, Shoulder external rotators, scapular adductors and thoracic erector muscles
15789102|NCT04540159|Diagnostic Test|Flow-cytometric analysis|Measuring the level of sCD25 (IL-2Ra), 4-1BB, B7.2 (CD86), Free Active TGF-β1, CTLA-4, PD-L1, PD-1, Tim-3, LAG-3, Galectin-9 in the intraabdominal ascites
15789103|NCT04540146|Diagnostic Test|Flow-Cytometric analysis|IL-2, 4, 5, 6, 9, 10, 13, 17A, 17F, 22, IFN-γ and TNF-α levels in the intraabdominal ascites
15789041|NCT04540601|Other|Continuation of antiresorptives in relation to tooth extraction (surgical tooth removal)|"We want to investigate the importance of an antiresorptive drug holiday (bisphosphonate, denosumab) in relation to tooth extraction. The experimental intervention in this trial is drug continuation starting before tooth extraction with primary closure.
~We simply ask the participating cancer patients to continue their high dose antiresorptive treatment for 4 months (intervention-period: 1 month pre-operative, 3 months post-operative) instead of taking a drug holiday."
15789042|NCT04540588|Device|Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)|An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.
15789043|NCT04540575|Behavioral|NICU Acquires MOM|Mother receives 1) hospital-grade electric smart breast pump for home use at no charge to the mother while the infant is in the NICU and the mother continues to pump; 2) free pickup of expressed MOM from home to transport to NICU 2-3 times per week during weekdays as needed; 3) receives payment for opportunity costs of pumping and handling milk at $18.50/day for each day that the mother pumps during her infant's NICU stay
15789044|NCT04540575|Behavioral|Mother Provides MOM|Mother receives standard Rush NICU lactation care
15789045|NCT04540562|Other|COPD app|The COPD app consisted of an 8 week self-management program. The app had three views: timeline, information page, and contact page. The timeline was classified in 8 weeks, and each week included the lung exacerbation plan, daily and extra medication, information and education and questionnaires. The first week also included a video of a pulmonologist explaining the purpose of the app and additional information about the functionalities of the COPD app. A video consultation was planned after after 4 weeks and a face-to-face consultation after 8 weeks.
15789046|NCT04540549|Behavioral|exercise|Jogging or cycling ≥5 days/week, 30-60 min/d
15789047|NCT04540536|Other|Continuous Glucose Monitoring|Participants will be provided with a Dexcom G6 continuous glucose monitor for the duration of the study.
15789048|NCT04540536|Other|Secure texting|A secure platform (TigerConnect) will be used for three-way communication between parents, participants, and clinical personnel
15789049|NCT04540523|Behavioral|Exergaming intervention group|In addition to usual daily activity, the parent and child from each family will receive 3 game consoles (Wii, Kinect, and LeapTV) and various exergames (e.g., Nickelodeon Fit, Dance and Sports, Just Dance) with all necessary peripherals to play the games. Specifically, they will receive one game console and related exergames every 2 months to experience the variety of exergames and maintain interest in the games over time. Each parent will receive a booklet (established in our pilots studies) provides a standardized gameplay curriculum to play during each session, and attend training workshops at baseline and 3rd month in the PI's lab. The parent will be instructed to have the child perform exergaming at home for 30 minutes/session, 5 times per week, for 6 months. The games will be age appropriate for children 4-5-years-old. The games have been easy for children to learn and use in our pilot studies.
15789050|NCT04540523|Behavioral|Traditional physical activity comparison|Home-based behavioral (e.g., nutrition/PA) interventions for young children usually only target parent for multiple reasons. In this study, group workshop sessions will offered to parents at baseline, 3rd month and 6th month, including information concerning how to promote PA and reduce sedentary behaviors. Identical curricular contents (e.g., dance/sports) for home PA will be offered to parents at baseline and 3rd month in the PI's lab. Parents will also learn about PA and sedentary behavior and their impact on health and cognition. Meanwhile, the intervention staff will encourage parents to increase their lifestyle activity such as taking stairs instead of the elevator and housecleaning. Parents will also learn to shape their child and their PA and sedentary behaviors to attain the following goals: 2 hour or less screen time and at least 180 min. PA per day for children; and at least 150 min. moderate PA for parents per week.
15789051|NCT04540510|Device|OPEP therapy|Oscillatory Positive Expiratory Pressure therapy
15789052|NCT04540510|Other|Standard care|Standard pneumonia care
15789053|NCT04540497|Drug|Inebilizumab|Inebilizumab is a monoclonal antibody that depletes B cells.
15789054|NCT04540497|Other|Placebo|Placebo
15789055|NCT04540471|Other|music|MT group receives additional music therapy
15789056|NCT04540471|Other|comprehensive in-patient education program|comprehensive in-patient education program
15789057|NCT04540458|Other|3D printed model|Mother or Mother/Father is given 3D printed model of fetus' face
15789058|NCT04540458|Other|Placebo|Mother or Mother/Father is given a picture of 3D ultrasound of fetus
15789059|NCT04540445|Other|Pupillary Assessment|Pupillary assessment with handheld pupillometer
15789062|NCT04540419|Biological|Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)|Intramuscular administration
15789063|NCT04540419|Biological|Placebo|Intramuscular administration
15789064|NCT04540406|Drug|NBT-NM108|Taken in the form of drinks four times a day (before each main meal and 2 hours after dinner) for 28 days. Each drink is prepared by mixing one sachet (30 g) with 500 ml of water.
15789065|NCT04540406|Other|Usual Care Only|Control group will also follow the same schedule except they will drink the same volume of water without NBT-NM108.
15789066|NCT04540393|Biological|AZD1222|Participants will receive 2 doses of AZD1222; the first dose will be administered on Day 1 and the second dose on Day 29. Unit dose strength(s) > 0.7 × 1011 vp/mL. Dosage level(s) 5 ×1010 vp (nominal). Route of administration Intramuscular injection
15789067|NCT04540380|Drug|Rituximab, Fludarabine, Cyclophosphamide, Thymic irradiation and Siplizumab|Conditioning regimen .Patients will receive Rituximab, Fludarabine, Cyclophosphamide, Thymic irradiation and Thymoglobulin
15789104|NCT04540133|Drug|dexamethasone 0.5mg/5ml solution|Patient with oral ulcerative conditions will be asked to rinse with dexamethasone 0.5mg/5ml solution three times a day for 4 weeks and expectorate
15789105|NCT04540133|Drug|dexamethasone 0.5mg/5ml solution in Mucolox™|Patient with oral ulcerative conditions will be asked to rinse with dexamethasone 0.5mg/5ml solution in Mucolox™ three times a day for 4 weeks and expectorate
15789068|NCT04540380|Procedure|Combined bone marrow and kidney transplant|Recipients will receive a conditioning regimen that includes rituximab on study days -7 and -2, fludarabine 10mg/m2/day on days -6 to -3 (4 doses), cyclophosphamide (22.5mg/kg/day) on days -5 and -4, followed by local thymic irradiation (7 Gy) on day -1 and Siplizumabon days -1, 0, and +1. Combined kidney and bone marrow transplant will be performed on study day 0. Methylprednisolone will be started at 250 mg/day on day 0 and tapered to prednisone 20mg by day 10 after which it will be continued until day 20. Prophylaxis will be provided for hemorrhagic cystitis, PCP, fungal infection, CMV, and perioperative infection. All patients who require any blood transfusion will receive only leukocyte-depleted and irradiated blood products for a period of at least 52 weeks following transplantation. The proportion of patients successfully weaned off immunosuppression without chimerism transition syndrome (CTS) will be assessed.
15789069|NCT04540367|Device|Blood flow restriction therapy|The study group underwent the same exercises as the control group modified by the use of a tourniquet for blood flow restriction during those exercises.
15789070|NCT04540354|Drug|Optimal Medical Therapy (OMT)|Patients will be treated according to Optimal Medical Therapy defined by the 2016 ESC guidelines for the management of acute and chronic heart failure.
15789071|NCT04540354|Device|Implantable cardioverter-defibrillator (ICD)|"An ICD consists of an electronic medical device and electrode leads. The surgery can be performed in local anaesthesia, but a short general anaesthesia is required if the ICD has to be tested giving the patient an electric shock. Besides the possibility to shock during arrhythmias the ICD can potentially terminate ventricular tachycardias by rapid pacing for short periods (small bursts of pacing).
~The subcutaneous defibrillator is an established and valid alternative to the conventional ICD for the preven-tion of SCD. According to current guidelines, the subcutaneous defibrillator should be considered as an alternative to transvenous defibrillators in patients with an indication for an ICD when pacing therapy for bradycardia support, cardiac resynchronisation or antitachycardia pacing is not needed."
15789072|NCT04540341|Other|Mulligan mobilization|Mulligan mobilization technique will be apply.
15789073|NCT04540341|Other|Core stabilization|Core stabilization technique will be apply.
15789074|NCT04540341|Other|Conventional therapy|Conventional therapy exercise will be apply.
15789075|NCT04540328|Other|Non-surgical periodontal treatment|
15789076|NCT04540315|Behavioral|MobiMD|MobiMD is a mobile app. This is an app available to IOS and Android devices only. The app provides a digitized version of the discharge instructions and provides push notifications to remind the participant of important instructions. In addition, the app allows participants (and their care teams) to record and track relevant clinical data.
15789077|NCT04540302|Device|Merit WRAPSODY Endovascular Stent Graft|Target lesion treated with stent graft placement
15789078|NCT04540302|Device|PTA|Target lesion treated with standard percutaneous transluminal angioplasty (PTA)
15789079|NCT04540289|Drug|Optimal Medical Therapy (OMT)|"Patients will be treated according to Optimal Medical Therapy defined by the following guidelines:
~2019 ESC guidelines for the diagnosis and management of chronic coronary syndromes
~2016 ESC guidelines for the management of acute and chronic heart failure"
15789080|NCT04540289|Device|Implantable cardioverter-defibrillator (ICD)|"An ICD consists of an electronic medical device and electrode leads. The surgery can be performed in local anaesthesia, but a short general anaesthesia is required if the ICD has to be tested giving the patient an electric shock. Besides the possibility to shock during arrhythmias the ICD can potentially terminate ventricular tachycardias by rapid pacing for short periods (small bursts of pacing).
~The subcutaneous defibrillator is an established and valid alternative to the conventional ICD for the preven-tion of SCD. According to current guidelines, the subcutaneous defibrillator should be considered as an alternative to transvenous defibrillators in patients with an indication for an ICD when pacing therapy for bradycardia support, cardiac resynchronisation or antitachycardia pacing is not needed."
15789081|NCT04540276|Drug|Inspiratory oxygen fraction|Median inspiratory oxygen fraction during general anesthesia
15789082|NCT04540263|Diagnostic Test|Flow Cytometric analysis|Measuring the level of IL-1β, IFN-α2, IFN-γ, TNF-α, MCP-1 (CCL2), IL-6, IL-8 (CXCL8), IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33 cytokines in the serum
15789083|NCT04540250|Other|questionnaire|conventional intra-oral examination and questionnaire
15789084|NCT04540237|Diagnostic Test|Flow-cytometric analysis|Flow-cytometric analysis of IL-1β, IFN-α2, IFN-γ, TNF-α, MCP-1 (CCL2), IL-6, IL-8 (CXCL8), IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33
15789085|NCT04540224|Diagnostic Test|Flow-Cytometric analysis|Measuring the level of serum IL-1β, IFN-α2, IFN-γ, TNF-α, MCP-1, IL-6, IL-8, IL-10, IL-12p (70), IL-17A, IL-18, IL-23 and IL-33
15789086|NCT04540211|Drug|Atezolizumab|Atezolizumab at a fixed dose of 1200 milligrams (mg) administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
15789087|NCT04540211|Drug|Tiragolumab|Tiragolumab at a fixed dose of 600 mg administered by IV infusion every Q3W on Day 1 of each 21-day cycle.
15789088|NCT04540211|Drug|Paclitaxel|Paclitaxel 175 mg/m^2 administered by IV infusion on Day 1 of each 21-day cycle for 6 cycles.
15789089|NCT04540211|Drug|Cisplatin|Cisplatin 60-80 mg/m^2 administered by IV infusion on Day 1 of each 21-day cycle for 6 cycles.
15789090|NCT04540211|Drug|Atezolizumab Matching Placebo|Atezolizumab matching placebo administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
15789091|NCT04540211|Drug|Tiragolumab Matching Placebo|Tiragolumab matching placebo administered by IV infusion, Q3W on Day 1 of each 21-day cycle.
15789092|NCT04540198|Behavioral|GamePlan4Care|GamePlan4Care; Experimental
15789093|NCT04540198|Behavioral|Resources4Care|R4C; Active Comparator
15789094|NCT04540185|Biological|Biological: oral polio vaccine|Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump
15789095|NCT04540185|Biological|Comparable Placebo|Placebo of a vaccine 0.1 ml administered orally on a sugar lump
15789096|NCT04540185|Drug|NA-831|Drug: NA-831 30 mg of NA-831 in a capsule administered orally
15789097|NCT04540185|Drug|Comparable Placebo of drug|Placebo 30 mg in a capsule administered orally
15789098|NCT04540185|Combination Product|Combination of oral polio vaccine and NA-831|Combination of biological: Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump and drug NA-831 30 mg in a capsule administered orally
15789099|NCT04540185|Combination Product|Comparable Placebo of Oral Polio Vaccine and Placebo of drug|Combination of biological placebo 0.1 ml administered orally on a sugar lump and drug placebo 30 mg in a capsule administered orally
15789111|NCT04540094|Drug|Human albumin|Any preparation of 5% Human Albumin Solution which has marketing authorisation in the UK to be used for this indication and is stocked by local hospital pharmacies at the participating sites, may be prescribed in this study
15789112|NCT04540094|Drug|Balanced crystalloid solution|"Any preparation of intravenous balanced crystalloid which has marketing authorisation in the UK to be used for this indication and is stocked by local hospital pharmacies at the participating sites, may be prescribed in this study."
15789113|NCT04540081|Other|Epic Healthy Planet Population Health Module|Electronic population health module which is tailored to increased adherence to USPSTF and CDC recommendations
15789114|NCT04540068|Drug|Transforaminal Epidural Injection|Injections above L3 will contain 1,5 ml lidocaine 1% and 10 mg dexamethasone and injections at L3 or below will contain 1,5 ml lidocaine 2% and 40mg methylprednisolone acetate in accordance with current Dutch anesthesiologic guidelines for usual care.
15789115|NCT04540055|Procedure|Paravertebral block|The subjects in this group received general anesthesia and USG-guided paravertebral block
15789116|NCT04540055|Procedure|General Anesthesia|The subjects in this group underwent MRM under routine general anesthesia without peripheral nerve block supplementation.
15789117|NCT04540042|Drug|SelK2 (Part 1)|I.V., multiple-dose (Day 1 and Day 22)
15789118|NCT04540042|Drug|Placebo (Part 1)|I.V., multiple-dose (Day 1 and Day 22)
15789119|NCT04540042|Drug|SelK2 (Part 2)|I.V., single-dose (Day 1)
15789120|NCT04540042|Drug|Placebo (Part 2)|I.V., single-dose (Day 1)
15789121|NCT04540029|Other|Maternal stress|Prenatal COVID-19-related stress retrospectively self-reported by mothers after delivery.
15789122|NCT04540016|Drug|[14C]HSK7653|25 mg of [14C]HSK7653 (radioactivity of 80 µCi) capsules are taken under fasted condition.
15789123|NCT04540003|Other|Access to School Based Health Centre|The SBHC will be staffed by a family physician, two pediatricians and a developmental pediatrician, each with at least one half-day of clinic time per week from September through June. The SBHC is also staffed by a clinic coordinator who is responsible for booking appointments on a first-referral, first-serve basis.
15789124|NCT04539990|Behavioral|Behavioral treatment for sleep difficulties|"This intervention is mediated by the parents. Parents are educated regarding sleep hygiene and instructed to follow simple rules which create a reliable evening routine and reduce exposure to stimulating factors that delay sleep onset (e.g., caffeine or exercise). In addition, parents are asked to initiate a fading behavioral protocol whereby they teach their child to fall asleep independently, with less parental attention. This requires parents to limit their interaction with their child after the children are put to bed so as not to interfere with sleep onset. This includes limiting conversations and lying in bed with the child. This behavioral approach is applied gradually and is expected to reduce the time it takes children to fall asleep."
15789125|NCT04539977|Drug|TQB2450|Inductive therapy: TQB2450 + EP Maintenance therapy: TQB2450
15789126|NCT04539977|Drug|TQB2450|Neoadjuvant therapy: TQB2450 + EP Adjuvant therapy: TQB245
15789127|NCT04539964|Procedure|Implant Procedure|The SetPoint System (study device) contains a miniaturized stimulator (implant) that is surgically implanted inside the left side of the neck on the vagus nerve (implant procedure). All eligible subjects will undergo the surgery under general anesthesia in outpatient settings.
15789128|NCT04539964|Drug|Conventional Synthetic DMARD|All subjects will continue to take at least one type of conventional synthetic DMARD at the same stable dose as for 4 weeks prior to consent
15789129|NCT04539964|Device|Active stimulation|Active stimulation for 1 min once per day
15789130|NCT04539964|Device|Non-active stimulation|Non-active stimulation for 1 min once per day
15789131|NCT04539951|Drug|Sertraline 200 milligram(mg)|All included participants will receive sertraline, initially at 50mg/d, with a weekly 50mg/d further increase, to the maximum recommended dosage (200mg/d) or to the maximum tolerated dosage (less than 200mg/d). Patients will be on their maximum dose by week 4, so allowing an assessment of response at 12 weeks
15789132|NCT04539951|Drug|Sertraline 300 milligram(mg)|In experimental phase II, the patients in this group will remain on sertraline (higher dosage): where sertraline 200mg has been tolerated, dosage will be increased by 50mg fortnightly to a maximal dose of 300mg/d or to the maximum tolerable dose (less than 300mg/d).
15789133|NCT04539951|Drug|Fluvoxamine|Fluvoxamine will be initiated at a dose of 50mg/d, increasing quickly to a maximal dose of 300mg/d or the maximum tolerated dose by week 4.
15789134|NCT04539951|Drug|Venlafaxine|venlafaxine will be initiated at 75mg/d, increasingly weekly by 75mg/day, to a maximal dose of 300 mg/d or the maximum tolerated dose.
15789135|NCT04539951|Drug|Augment with Memantine|Sertraline will be augmented with memantine initially at 5mg/d, and increasing by 5mg/d weekly to a maximal dose of 20mg/d (10mg twice daily) or the maximum tolerated dose
15789136|NCT04539951|Drug|Augment with Aripiprazole|Sertraline will be augmented with aripiprazole, initially at 5mg/d, and increasing by 5mg/d weekly to a maximal dose of 20mg/d or the maximum tolerated dose
15789137|NCT04539938|Drug|tucatinib|300 mg orally twice daily
15789138|NCT04539938|Drug|trastuzumab deruxtecan|5.4 mg/kg via intravenous (into the vein; IV) infusion on Day 1 of each of 21-day cycle
15789139|NCT04539925|Other|Acute coronary syndrome|The effect of air pollution on acute coronary syndrome
15789140|NCT04539912|Device|angulated screw retained crown|ASC abutment was used in AG;
15789141|NCT04539912|Device|cemented crown|prefabricated Ti abutment was used in CG
15789142|NCT04539899|Other|VR+|Use of a virtual reality helmet during IUD insertion
15789143|NCT04539886|Device|CellFX System|CellFX System consists of a console combined with a handpiece and coupled with a sterile single patient-use treatment tip (1.5 x 1.5mm, 2.5 x 2.5mm, and 5.0 x 5.0mm)
15789144|NCT04539886|Device|Intralesional Electrodesiccation|Hyfrecator electrosurgical unit with a non-insulated needle-shaped electrode
15789145|NCT04539873|Drug|Colchicine 0.5 MG|Patientes in this arm will receive study medication colchicine 1,5 orally on the first day (initially two pills of 0,5 mg and 0.5 mg at 2 hours), followed by 0.5 mg every 12 hours on days 2 to 7, and continuing with 0.5 mg per day until completing 14 ± 1 days. The duration of treatment will be 14 ± 1 days, depending on the clinical judgment of the investigator.
15789146|NCT04539873|Combination Product|CONTROL GROUP|In this case, the centers where the patients are enrolled will adhere to the Colombian guidelines (Colombian Consensus of the Colombian Association of Infectious Diseases)
15789147|NCT04539860|Device|Transdermal Optical Imaging|Blood pressure measurements completed by standard assessment methods and Transdermal Optical Imaging
15789148|NCT04539847|Device|High-end hearing aid|hearing aid with premium level of technology
15789149|NCT04539847|Device|Basic hearing aid|hearing aid with basic level of technology
15789150|NCT04539834|Other|electrolytes|measuring level of electrolytes
15789151|NCT04539821|Other|VCPM|VCPM is a multi-component intervention consisting of already-established care processes and materials.
15789152|NCT04539808|Drug|Capecitabine|Given PO
15789153|NCT04539808|Drug|Fluorouracil|Given IV
15789154|NCT04539808|Drug|Irinotecan Hydrochloride|Given IV
15789155|NCT04539808|Drug|Leucovorin Calcium|Given IV
15789156|NCT04539808|Drug|Losartan Potassium|Given PO
15789157|NCT04539808|Drug|Oxaliplatin|Given IV
15789158|NCT04539808|Radiation|Radiation Therapy|Undergo short-course or long-course RT
15789159|NCT04539808|Procedure|Resection|Undergo surgical resection
15789160|NCT04539795|Drug|Alvelestat|oral tablet
15789161|NCT04539795|Drug|Placebo|oral tablet
15789162|NCT04539782|Other|Physiotherapy intervention|Compare the effect of structured pelvic floor muscle training supported by physiotherapist post operation on POP on recurrence of symptoms or symptoms in a new compartment, quality of life and pelvic floor muscle function.
15789163|NCT04539769|Procedure|conventional BI|After standard laparoscopic distal gastrectomy with radical lymphadenectomy, the gastrointestinal continuity will be restored with conventional Billroth I gastroduodenostomy.
15789164|NCT04539769|Procedure|long-limb BII|After standard laparoscopic distal gastrectomy with radical lymphadenectomy, the gastrointestinal continuity will be restored with Billroth II gastrojejunostomy using 100 cm-long biliopancreatic limb.
15789165|NCT04539769|Procedure|long-limb RY group|After standard laparoscopic distal gastrectomy with radical lymphadenectomy, the gastrointestinal continuity will be restored with Roux-en-Y reconstruction using 100 cm-long Roux limb and standard biliopancreatic limb.
15789166|NCT04539756|Behavioral|positive psychological intervention|Participants will be asked to complete writing activities every other day. They will choose which activity they would like to complete each day, from a menu of six different activities. Each activity is a different positive psychology exercise.
15789167|NCT04539756|Behavioral|Active control condition|Participants will be asked to complete the same writing activity each day, which will ask them to list their daily activities. Participants will be encouraged to process their daily activities superficially by the receiving the following instructions: (1) list each activity in brief, incomplete sentences, (2) document only facts about performing the activities, and (3) to not provide any information about emotional responses to performing the activities. By following these instructions, participants are presumably deriving less meaning from their activities, which may minimize gains in positive affect in the active control condition
15789170|NCT04539704|Device|magnet and sham|In same subject some areas will have magnet and others will have sham
15789171|NCT04539691|Device|Magnet|Magnet or Sham is worn by subject in close proximity to their described maximum pain site
15789172|NCT04539665|Procedure|Extended mesenteric resection.|Patients will undergo an ileocolic resection involving high ligation of the ileocolic pedicle, complete mobilization of the mesentery off of the retroperitoneum, and resection of the entire mesentery related to the specimen.
15789173|NCT04539652|Drug|Experimental|Experimental group are treated with TenofoBell®
15789174|NCT04539639|Drug|Jacketinib|In the morning: 1 tablet of 50mg and 75mg placebo, 1 tablet of 50mg Jaktinib; In the evening: 1 tablet of 50mg and 75mg placebo, 1 tablet of 50mg Jaktinib.
15789175|NCT04539639|Drug|Jacketinib|In the morning: 2 tablet of 50mg placebo, 1 tablet of 75mg Jaktinib; In the evening: 2 tablet of 50mg placebo, 1 tablet of 75mg Jaktinib.
15789176|NCT04539639|Drug|Jacketinib|In the morning: 1 tablet of 75mg placebo, 2 tablet of 50mg Jaktinib; In the evening: 1 tablet of 75mg placebo, 2 tablet of 50mg Jaktinib.
15789177|NCT04539639|Drug|placebo|In the morning: 2 tablet of 50mg placebo, 1 tablet of 75mg placebo;In the evening: 2 tablet of 50mg placebo, 1 tablet of 75mg placebo.
15789178|NCT04539626|Drug|Estrogen Therapy|EVRA skin patches with norelgesetromin 6mg / ethinyl estradiol 0.60mg, (1 patch will be placed every week during 21 days)
15789179|NCT04539613|Drug|HPFSH & HMG|. Various gonadotropin preparations
15789180|NCT04539600|Drug|Camrelizumab|Camrelizumab is a type of anti-PD-1 antibody that could enhance the immune system of the patient to fight cancer.
15789181|NCT04539587|Other|Quality of life|"The patient will receive the following questionnaires to be completed :
~EORTC QLQ-C30 EORTC QLQ-BR23 EORTC SHQ-C22"
15789182|NCT04539574|Procedure|7 Tesla Magnetic Resonance Imaging|Undergo 7T MRI
15789183|NCT04539574|Other|Questionnaire Administration|Ancillary studies
15789184|NCT04539561|Device|PiQo4 Laser System|PiQo4 Laser System for treatment of hand pigmentation
15789185|NCT04539548|Drug|Dextenza|Dextenza, dexamethasone ophthalmic insert
15789186|NCT04539548|Drug|Prednisolone|Prednisolone, acetate ophthalmic suspension
15789187|NCT04539535|Other|General Movements Assessment on two different surfaces in infants with DS and typically infants on the same day|Different surface
15789188|NCT04539522|Behavioral|Three-dimensionally corrective exercise for scoliosis|Three-dimensionally corrective exercise for scoliosis is based the theory of physiotherapeutic scoliosis specific exercises, which focus on 3-dimension self-correction and consists of two parts:1)outpatient treatment including stretching, three-dimensional auto-correction(combine with specific breathing mode, isometric training to correct abnormal spinal physiological curvatures in sagittal plane, and accompany with wedge pad to modify humpback, waist asymmetry, pelvic rotation in horizontal. While in coronal plane, longitudinal axial stretching, pelvic adjustments will be conducted to reduce the lateral curvature.), balance and stability training, combined with manual fascia relaxation therapy, and and breathing training; 2)family rehabilitation: combines self-correcting gymnastics with daily posture management, etc., forming the individual exercise approach for each patient.
15789189|NCT04539522|Behavioral|Conventional exercise|Conventional exercise consists a series of spine exercises focusing on core strength training.
15789190|NCT04539509|Behavioral|Exercise Prescription|A specific exercise prescription, based on the results of a treadmill test.
15789191|NCT04539509|Behavioral|Treadmill Test|A symptom-limited treadmill test, using the Buffalo Concussion Treadmill Test (BCTT) protocol.
15789192|NCT04539509|Device|Monitoring|Activity monitoring using a Fitbit.
15789193|NCT04539496|Drug|XZP-3287|a small molecular, oral potent, selective CDK4/6 inhibitor
15789194|NCT04539483|Drug|HDIT101 (blinded therapy)|Patients will be treated with with topical HDIT101 (twice daily for 2 days). Blinded study drug will be applied to the first 2 lesions occuring in the treatment phase.
15789195|NCT04539483|Drug|Placebo (blinded therapy)|Patients will be treated with with topical placebo (twice daily for 2 days). Blinded study drug will be applied to the first 2 lesions occuring in the treatment phase.
15789196|NCT04539483|Behavioral|Photo documentation of orolabial herpes lesions|Patients will be asked to document their orolabial lesions with photos by using their smart phone
15789197|NCT04539483|Behavioral|Completion of questionnaires (patient-reported outcomes)|Patients will be asked to document their health status in questionnaires by using their smart phone
15789198|NCT04539483|Procedure|28-day swabbing of orolabial region|Patients will be asked to complete 3 episodes of 28-day swabbing of orolabial lesions
15789199|NCT04539483|Procedure|Blood drawings|Blood will be drawn for e.g. safety lab, HSV-analysis, pharmacokinetic etc.
15789200|NCT04539470|Drug|UTTR1147A|UTTR1147A will be administered intravenously (IV) per the dosage specified in each dose escalation cohort.
15789201|NCT04539457|Behavioral|Desktop helper|The 'Desktop Helper (version 10)' is a user-friendly information sheet developed by the IPCRG. This 'Desktop Helper (version 10)' has been developed in co-operation with several clinicians and experts in the field of COPD. These practical guidance and support are a tool for clinicians working in primary care. The 'Desktop Helper (version 10)' contains specific advice to prevent clashes. The specific advice of the 'Desktop Helper (version 10)' will be elaborated in decision trees. These will be integrated and implemented into the MedicomSmart system by Stichting Healthbase. Subsequently, these decision trees will provide GPs to conduct case-finding of COPD patients with 'medication-comorbidity clashes'. These are based on the 'Desktop Helper (version 10)' . Case finding will be done by the GP or the practice nurse (POH).
15789202|NCT04539457|Behavioral|E-learning|The e-learning module will be explanatory to the 'Desktop Helper (version 10)' how to perform the case-finding and in what way the case-finding can be beneficial to the patients with COPD and their (co)morbidities. This e-learning module will include several example cases and how to deal with the case-finding and the next steps in the process to reduce the (co)morbidity clashes with the medications of COPD. Together with the decision trees as inferred from the 'Desktop Helper (version 10)', the e-learning module is aimed at inducing a behavioral change in prescribing medication to a patient suffering from COPD and one or more (co)morbidities.
15789203|NCT04539444|Biological|CD19/22 CART|CD19/22 CART cells are administrated in a 3-day split-dose regimen at dose of 0.5- 2×10*107 CART cells per kilogram of body weight.
15789204|NCT04539444|Drug|Tislelizumab|Patients will receive Tislelizumab 200mg/dose every 3 weeks.
15789205|NCT04539431|Genetic|validation of new technologies|Development of a new molecular assay on tissue as well as on liquid biopsies (plasma and CSF), based on a single, open, real-time PCR platform with unprecedented sensitivity
15789206|NCT04539418|Drug|Vitamin K 2|Patients will be monitored during the whole protocol.
15789207|NCT04539405|Device|To evaluate sevoflurane consumption when using Memsorb|Sevoflurane administration at 0.2L.min-1 (minimal gas flow)
15789208|NCT04539405|Device|To evaluate sevoflurane consumption when using classical Dräegersorb|Sevoflurane administration at 2L.min-1 (classical gas flow)
15789209|NCT04539392|Other|Questionnaires on sexuality|Panel of questionnaires assessing sexuality, relationship satisfaction, and body image
15789210|NCT04539379|Drug|Magnesium sulfate|intravenous infusion
15789211|NCT04539379|Drug|Labetolol|intravenous infusion
15789215|NCT04539353|Other|Heart Rate Variability|Heart Rate Variability will be measured with a Polar device.
15789216|NCT04539353|Other|Pain intensity|Pain Intensity will be measured with a Numeric Rating Scale and Visual Analogue Scale
15789217|NCT04539340|Biological|GNR-055|Single intravenous administration
15789218|NCT04539327|Drug|Rucaparib|Participating local sites (GEICO-associated hospitals with expertise in gynecological cancer management) will enter clinical data of those patients who have previously participated in the rucaparib access program (RAP) in Spain and have given their consent.
15789219|NCT04539314|Drug|Bupivacain|We will carry out the TAP block using 0.5 ml/ kg bupivacaine 0.25%
15789220|NCT04539314|Drug|Dexmedetomidine o.5 μg|We will carry out the TAP block using using 0.5 ml/ kg bupivacaine 0.25% with dexmedetomidine 0.5 μg / kg
15789221|NCT04539314|Drug|Dexmedetomidine 1 μg|We will carry out the TAP block using using 0.5 ml/ kg bupivacaine 0.25% with dexmedetomidine 1 μg / kg
15789222|NCT04539301|Diagnostic Test|Estimated anticoagulant level (conversion factor x anti-Xa activity)|Estimated anticoagulant level (conversion factor x anti-Xa activity)
15789223|NCT04539275|Drug|Convalescent Plasma|Convalescent plasma from persons recovered from SARS-CoV-2 is being used to treat hospitalized individuals with complicated COVID-19 infection.
15789224|NCT04539275|Other|Masked Saline Placebo|0.9% saline solution will be used as the Masked Saline Placebo
15789225|NCT04539262|Drug|Remdesivir (RDV)|Administered as an aerosolized solution
15789226|NCT04539262|Drug|Placebo|Administered as an aerosolized solution
15789227|NCT04539249|Drug|Magnesium sulphate|"1g of paracetamol as an I.V infusion and 4g of magnesium sulphate as an I.V. bolus preoperatively. Continuous infusion of 1g/hr of magnesium sulphate intraoperatively and for the first 2 hours post-operatively. Further post-operatively, 100 mg of suppository diclofenac 12 hourly, intravenous paracetamol 1g 6 hourly, both over 24 hours.
~N.B: Intramuscular pentazocine 30 mg (45 mg if patient is > 70 kg) will be used only as rescue analgesia as needed (that is, only on patients' request for further analgesia or following an assessment of moderate to severe pain despite non-opioid analgesia) at least 4 hourly during the first 24 hours after caesarean section."
15789327|NCT04538352|Drug|Semaglutide|Medication for type 2 diabetes management
15789228|NCT04539249|Drug|Pentazocine|Post-operatively, suppository diclofenac 100mg 12 hourly, intramuscular pentazocine 30 mg (45 mg if patient is > 70 kg) 6 hourly, intravenous paracetamol 1g 6 hourly, all for 24 hours.
15789231|NCT04539223|Drug|Evolocumab|Autoinjector 1-mL deliverable volume of 140 mg/mL
15789232|NCT04539210|Device|Electric Welded Metal Framework|Screw-retained Maxillary Complete Denture With Electric Welded Metal Framework
15789233|NCT04539184|Other|Motion Style Acupuncture Treatment (MSAT)|MSAT required a part of the patient's body to move passively or actively while acupuncture needles are retained.
15789234|NCT04539184|Other|Acupuncture|General acupuncture
15789235|NCT04539171|Other|Pain Neuroscience Education and Physical Exercise|Patients assigned to the experimental group perform a PNE program consisting of seven sessions, with therapeutic PE. PNE is a health education intervention aims to provide up-to-date information on neuroscience advances in the field of chronic pain.
15789236|NCT04539158|Device|Direct Current Cardioversion|The patient is sedated and shocked using an external defibrillator to terminate the arrhythmia and restore a normal intrinsic rhythm (i.e., normal sinus rhythm).
15789237|NCT04539145|Device|Chocolate PTA Balloon|Chocolate PTA Balloon
15789238|NCT04539145|Device|conventional balloon angioplasty|conventional bal-loon angioplasty
15789239|NCT04539132|Behavioral|ABI Wellness Program|The ABI Wellness program includes a computerized task which will be completed by all participants remotely. The exercise is a sustained visual-spatial processing task of progressively increasing difficulty. Subjects are presented with an analog clock face, initially showing only one hand. The subject uses a keyboard to enter a value for the hour shown. Feedback on the computer screen indicates whether the response is correct or incorrect. If the response was incorrect, the subject continues to respond until the correct response is entered. After this, a new clock face is shown. Once subjects reach a criterion of 90% accuracy over a series of consecutive responses, an additional hand is added to the clock face. Participants will complete the program at home, online, and will be required to be present on a video call during the exercise with the other participants and research assistants. The program is 150 hours over 6 months, through twice weekly 3-hour sessions.
15789240|NCT04539119|Drug|Tenofovir|Participants will be given tenofovir 300mg (1 capsule) qd po two weeks before the first cycle of treatment. HBV DNA will be measured before each cycle of chemotherapy or immunotherapy. Tenofovir will be given until the copy count of HBV DNA drops below 1*10^3/L.
15789241|NCT04539119|Drug|Entecavir|Participants will be given entecavir 0.5 mg (1 capsule) qd po from two weeks before the first cycle of treatment until one year after the end of treatment. HBV DNA will be measured before each cycle of chemotherapy or immunotherapy. Entecavir will be given until one year after the end of treatment.
15789242|NCT04539106|Drug|intravitreal injection of Ranibizumab|intravitreal injection of 0.25 mg/0.025 ml ranibizumab with a 30-gauge needle 1.5mm from limbus
15789243|NCT04539093|Other|Exposure of interest - Use of left ventricular assist device (LVAD)|Mechanical circulatory support devices such as left ventricular assist device is used as a treatment option for patients with end-stage heart failure.
15789244|NCT04539080|Procedure|transversus abdominis plane block|transversus abdominis plane block before or after laparoscopy operation
15789245|NCT04539067|Drug|HHMG|Induction of ovulation from the 2nd day of cycle to 5th day then follow the diameter of follicle Use transvaginal ultrasound When diameter of follicle 18 to 22 patients receiving HMG
15789246|NCT04539054|Dietary Supplement|ENGN Shred|ENGN Shred is a multi-ingredient pre-workout supplement.
15789247|NCT04539054|Dietary Supplement|Nutricost caffeine powder|Caffeine powder.
15789248|NCT04539054|Dietary Supplement|Crystal Light|Non-caloric Crystal Light matched for the pre-workout in terms of flavor and consistency.
15789249|NCT04539041|Drug|antisense oligonucleotide|solution of antisense oligonucleotide injected intrathecally (spine tap) at multiple dose levels
15789250|NCT04539041|Drug|placebo|matching placebo for each dose level
15789251|NCT04539028|Procedure|Emergency Abdominal surgery|Emergency Abdominal surgery
15789252|NCT04539015|Device|Prevena Plus|PREVENA Plus is a negative pressure wound therapy device intended for use on surgical incisions that continue to drain following sutured or stapled closures.
15789253|NCT04539002|Behavioral|Aerobic exercise|Aerobic exercise performed on a stationary ergometer for 30 minutes, thrice weekly, with graded supervision. Participants will participate in the intervention over 24 weeks.
15789254|NCT04539002|Behavioral|Education Group Control|A monthly, hour-long, class over various MS topics and symptoms, led by a trained facilitator.
15789255|NCT04538989|Drug|RZ358 Sequential Group Cohort 1|IV infusion for 8 weeks (3 mg/kg bi-weekly for 8 weeks)
15789256|NCT04538989|Drug|RZ358 Sequential Group Cohort 2|IV infusion for 8 weeks (6 mg/kg bi-weekly for 8 weeks)
15789257|NCT04538989|Drug|RZ358 Sequential Group Cohort 3|IV infusion for 8 weeks (9 mg/kg bi-weekly for 8 weeks)
15789258|NCT04538989|Drug|RZ358 Sequential Group Cohort 4|IV infusion for 8 weeks (bi-weekly fixed dose-titration from 3 to 9 mg/kg for the first 4 weeks, followed by a fixed 9 mg/kg dose amount thereafter for the remaining 4 weeks)
15789259|NCT04538976|Drug|Sildenafil|Sildenafil in standard dosage
15789260|NCT04538963|Device|Orthodontic Band affixed with Glass Ionomer Cement|Glass ionomer cement utilized to affix a blank orthodontic band to the tooth; the mechanical retention of the band will also help retain cement in contact with the tooth- the hypothesis is that the fluoride release from the cement will aid in remineralization of tooth structure.
15789261|NCT04538950|Diagnostic Test|PET/CT|Positron emission tomography-computed tomography is an image test that helps show detail about how tissues and organs are functioning. A radioactive drug (tracer) is used in the PET scan.
15789262|NCT04538937|Other|no intervention|no intervention
15789263|NCT04538924|Other|extended clinical, laboratory and instrumental examination; treatment options comparison|Multimodality investigation and different treatment comparison
15789264|NCT04538911|Drug|BCG-PPD|BCG-PPD was used for skin test in 40 TB patients, and BCG-PPD was marketed in other 40 TB patients (as control)
15789265|NCT04538885|Biological|The pleiotropic factor derived from mesenchymal stem cells|The pleiotropic factor derived from mesenchymal stem cells was smeared on the wound with a dosage of (2.5mg/2cm2), and then the wound was covered with a foam dressing; the dressing was changed every 3 days to reach clinical healing as the end of the trial.
15789266|NCT04538872|Behavioral|StraDiMS implicit|participants perform a goal-directed stepping task and try to react as fast as possible by stepping on a tile that lights up. Response time (the time between the tile lighting up and the participant stepping on the tile) is the outcome measure of the task. The implicit learning conditions and the explicit learning condition differ from each other in the instructions given prior to the task. The latter group will get more knowledge on the task than the former.
15789267|NCT04538872|Behavioral|StraDiMs explicit|participants perform a goal-directed stepping task and try to react as fast as possible by stepping on a tile that lights up. Response time (the time between the tile lighting up and the participant stepping on the tile) is the outcome measure of the task. The implicit learning conditions and the explicit learning condition differ from each other in the instructions given prior to the task. The latter group will get more knowledge on the task than the former.
15789268|NCT04538846|Other|Culinary art therapy|Culinary art therapy is a novel approach which broadly perceives food and cooking as enabling participants to explore needs, patterns and relationships and facilitate therapeutic processes.
15789269|NCT04538833|Drug|monosialic gangliosides|The experimental group received 80 mg of monosialic gangliosides (GM1) on days -1, 1, and 2 of albumin-bound paclitaxel(GM1 is a single infusion).
15789270|NCT04538833|Other|Placebo|The control group received placebo on days -1, 1, and 2 of albumin-bound paclitaxel (placebo as a single infusion)
15789271|NCT04538820|Drug|Dexamethasone 4 mg IV-control|dexamethasone 4 mg will be administered at induction of anesthesia for postoperative nausea and vomiting proflaxis to normal weight patients.
15789272|NCT04538820|Drug|Dexamethasone 4 mg IV|dexamethasone 4 mg will be administered at induction of anesthesia for postoperative nausea and vomiting proflaxis to obese patients
15789273|NCT04538820|Drug|Dexamethasone 8 mg IV|dexamethasone 8 mg will be administered at induction of anesthesia for postoperative nausea and vomiting proflaxis to obese patients
15789274|NCT04538807|Diagnostic Test|electromyography|Electromyography (EMG) is an electrodiagnostic medicine technique for evaluating and recording the electrical activity produced by skeletal muscles.
15789275|NCT04538794|Drug|CDX-0159|Administered intravenously
15789276|NCT04538794|Drug|Normal Saline|Administered intravenously
15789277|NCT04538781|Device|VASCADE MVP VVCS|The VASCADE MVP Venous Vascular Closure System (VVCS) is indicated for the percutaneous closure of femoral venous access sites while reducing time to ambulation, total post-procedure time, time to hemostasis, and time to discharge eligibility in patients who have undergone catheter-based procedures utilizing 6 - 12F inner diameter (maximum 15F OD) procedural sheaths, with single or multiple access sites in one or both limbs.
15789278|NCT04538768|Procedure|Mesh augmentation|P4HB retromuscular mesh placement for prevention of lateral incisional hernia after stomal closure
15789279|NCT04538768|Procedure|Direct suture|direct fascia suture
15789280|NCT04538755|Drug|Placebo oral capsule|Placebo before sleep
15789281|NCT04538755|Drug|DAW2020 oral capsule|DAW2020 34 mg 4 h before sleep, single night administration
15789282|NCT04538742|Drug|Trastuzumab deruxtecan|T-DXd: administered as an IV infusion
15789283|NCT04538742|Drug|Durvalumab|Durvalumab: administered as an IV infusion
15789284|NCT04538742|Drug|Paclitaxel|Paclitaxel: administered as an IV infusion
15789285|NCT04538742|Drug|Pertuzumab|Pertuzumab: administered as an IV infusion
15789286|NCT04538742|Drug|Tucatinib|Tucatinib administered orally (tablet) twice daily
15789287|NCT04538729|Behavioral|Acne Vulgaris|Alternative medicine and complementary therapies that acne vulgaris patients apply without informing the doctor, how they learn these techniques, what make them use these techniques for their illness
15789288|NCT04538716|Procedure|transconjunctival lower blepharoplasty|transconjunctival lower blepharoplasty associated with stromal vascular fraction gel (SVF-gel)
15789289|NCT04538703|Behavioral|acne vulgaris|Social media use of acne vulgaris patients, a questionnaire will be asked the patients and try to learn how they use social media for getting information about their disease.
15789290|NCT04538690|Other|Shoulder Exercises|Exercises consist of shoulder range of motion, releasing exercises, strength training, stretching.
15789291|NCT04538690|Other|Electrotherapy|TENS, US
15789292|NCT04538677|Device|Video consultation|A two-way audio and visual connection between patients and surgeons
15789293|NCT04538664|Drug|Amivantamab|Amivantamab will be administered as an IV infusion at a dose of 1400 mg (1750 mg if body weight is >=80 kilogram [kg]) by once weekly up to Cycle 2 Day 1, then 1750 mg (2100 mg if body weight is >=80 kg) on Day 1 of each 21-day cycle, starting with Cycle 3.
15789294|NCT04538664|Drug|Pemetrexed|Pemetrexed will be administration as 500 mg/m^2 IV infusion (with vitamin supplementation) on Day 1 of each 21-day cycle and then as maintenance monotherapy until disease progression in Arms A and B.
15789295|NCT04538664|Drug|Carboplatin|Carboplatin will be administration as AUC 5 IV infusion for up to 4 cycles on Day 1 of each 21-day cycle.
15789296|NCT04538638|Procedure|Mesenteric sparing ileocolic resection|Mesentery left in situ
15789297|NCT04538638|Procedure|Central mesenterectomy ileocolic resection|Mesentery is taken up to the level of the ileocolic trunk
15789298|NCT04538625|Drug|Crofelemer 125 MG [Mytesi]|Randomized, Double-blind, Placebo-controlled, two arm trial
15789299|NCT04538625|Drug|Placebo|Matching placebo tablets
15789328|NCT04538352|Drug|Insulin Degludec|Medication for type 2 diabetes management
15789329|NCT04538352|Drug|Insulin aspart|Medication for type 2 diabetes management (rapid-acting)
15789330|NCT04538326|Behavioral|Exercise|Participants performed stepping movements that were either cued by the investigator or interacted with a video game. There were three video game exercises that all involved stepping in either a repeated or a random pattern that was either self-paced or game paced.
15789331|NCT04538313|Drug|Tumor infiltrating lymphocyte|Tumor infiltrating lymphocytes were isolated from tumor tissues from tumor biopsy or operation. These TILs were cultured in human IL-2 medium for 4 to 5 weeks. 10e9 to 10e10 TILs were yielded. The phenotype, function and sterile were detected before these TILs infused patients.
15789300|NCT04538612|Device|measure capillary refill time|"Each time, capillary refill time will be evaluated three times consecutively by clinical method applying a firm pressure with the finger during 15s, then brutally releasing it, and estimating time of skin recoloration with a chronometer and by DiCART TM device
~Three vascular occlusion tests will be successively performed with a cuff during less than 10 minutes:
~Arterial vascular occlusion test (50mmHg above systolic arterial pressure of the healthy volunteers),
~Veinous vascular occlusion test (30mmHg),
~Control test without vascular occlusion test. Capillary refill time measurements will be repeated just before, during and just after vascular occlusion tests.
~Randomization determine the order of the vascular occlusion tests. Investigators performing capillary refill time evaluation will be blinded from it. Vascular occlusion tests will be alternatively performed by one and the other limb. The whole protocol will be performed at the upper and then at the lower limb."
15789301|NCT04538599|Drug|RD13-01 cell infusion|Universal CAR-T cells targeting CD7
15789302|NCT04538573|Device|Virtual Reality Distraction|Patients in this group will be offered to use Oculus Rift goggles while undergoing the burn treatments, dressing changes and hydrotherapy to reduce pain and anxiety during treatment. The goggles will display Dreamland, a virtual reality videogame created by our team to maximize fun, diminish difficulty, and motion sickness. The system will be available 5 minutes before treatment to the patient in order to ease acclimatation to the goggles until the end of the treatment session.
15789303|NCT04538573|Drug|Standard Treatment|During this sequence, patients with standard care will only be offered standard pharmacological treatment. Use of any co-interventions for pain or anxiety management (music, comforting, child life specialist or other) during this sequence will be documented.
15789304|NCT04538560|Procedure|polar body biopsy|Undergo polar body biopsy, and the NGS technology will be used to evaluate the polar body euploidy and then predict the euploidy of the oocyte. Embryo transfer priority according to the NGS test results and morphological scores.
15789305|NCT04538547|Radiation|Accelerated Radiotherapy|Accelerated Chemoradiotherapy followed by 3 cycles of Adjuvant chemotherapy. Patients will be treated with radiotherapy for 6 days per week from Monday to Saturday
15789306|NCT04538547|Radiation|Non Accelerated Radiotherapy|Chemoradiotherapy followed by 3 cycles of Adjuvant chemotherapy. Patients will be treated with radiotherapy for 5 days per week from Monday to Friday
15789307|NCT04538534|Drug|Nicardipine|To compare the association of nicardipine and isosorbide dinitrate vs isosorbide dinitrate alone on the rate of occurrence of radial artery spasm
15789308|NCT04538521|Dietary Supplement|Niacin|The dose for a slow-released form of niacin will be 500-1000 mg/day. The daily niacin dose, 250 mg/day, is gradually escalated by 250 mg/month so that the full dose is reached after 2 months. The intervention time with the full niacin dose is 8 months and subsequently total intervention time 10 months.
15789309|NCT04538508|Device|Diathermy|10 sessions of 12 minutes of radiofrequency diathermy at the anterior surface of the knee, in constant movement
15789310|NCT04538508|Other|Supervised knee exercises|Daily hamstrings exercises, quadriceps exercises and hip exercises, 20 minutes of duration.
15789313|NCT04538469|Other|COVID visitation restrictions|Visitation to patients in hospitals in Scotland was ceased due to the COVID 19 pandemic. Slow reintroduction of visitors has been introduced, however not to the pre COVID 19 levels. This study will examine the effects of these restrictions on patients in the cardiothoracic critical care unit that do not suffer from COVID 19.
15789314|NCT04538456|Other|questionnaire and optional interview|Participants will be sent an online or paper questionnaire. If participants have expressed an interest in taking part in an interview, they may be contacted by a member of the research team. The interviews will be conducted over the phone at time suitable for the participant. There will be no study specific hospital visits.
15789315|NCT04538443|Other|functional capacity|impact of hemodialysis on functional capacity in children with CKD
15789316|NCT04538443|Other|muscle strength|impact of hemodialysis on muscle strength in children with CKD
15789317|NCT04538443|Other|Quality of life of children|impact of hemodialysis on Quality of life in children with CKD
15789318|NCT04538443|Other|Quality of life of families|impact of hemodialysis on Quality of life of families of children with CKD
15789319|NCT04538430|Device|SPRINT percutaneous peripheral nerve stimulator placed|Placement of a SPRINT percutaneous peripheral nerve stimulator targeting the bilateral medial branches at the suspected level of pain generation. This procedure is done as standard of care.
15789320|NCT04538417|Device|Cooled Radiofrequency Ablation|RFA procedures will be performed with modification accounting for appropriate C-RFA technique. Participant will be positioned prone and skin prepped with chloroprep. Ultrasound probe will be placed on residual limb at a transverse angle in order to view the nerve and associated neuroma in long-axis. The probe will be advanced to the site of the stump neuroma. C-RFA electrode will be placed adjacent to neuroma. Needle will be connected via wire to a cooled radiofrequency generator. Motor and sensory testing will be performed to reproduce or exacerbate the RLP and / or PLP. At the site of the neuroma, 2 mL of local anesthetic will be injected through the needle. C-RFA lesions will be created by using the typical C-RFA protocol. Upon completion needle will be removed. Following ablation, 0.5 mL of 0.5% bupivacaine will be injected at the site of the ablated neuroma to provide post procedure analgesia.
15789321|NCT04538404|Procedure|Colon Surgery|Right, left colon surgery, transverse colon surgery, multiple colon surgery in open and minimally invasive surgert
15789322|NCT04538391|Drug|local ifiltration Bupivacaine, Meloxican and placebo|no other intervention done
15789323|NCT04538378|Drug|Olaparib|Olaparib tablet will be administered at a total daily dose of 600 mg orally in two divided doses, approximately 12 hours apart.
15789324|NCT04538378|Drug|Durvalumab|Durvalumab will be administered IV into a peripheral or central vein on Day 1 of every cycle at a flat dose of 1,500 mg.
15789325|NCT04538365|Drug|Triclosan 0.5 % Topical Solution|Hand antisepsis by scrub Surgical Hand scrubbing using triclosan 0.5% solution both hands using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side
15789326|NCT04538365|Drug|propanolol|Hand antisepsis by scrub Surgical Hand scrubbing using Propanolol 60% solution both hands using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side
15789332|NCT04538300|Diagnostic Test|Abramowitz Emesis Score|Postoperative vomiting was evaluated by Abramowitz emesis score in recovery room.
15789333|NCT04538300|Diagnostic Test|Degree of nausea|Degree of postoperative nausea was evaluated.
15789334|NCT04538300|Diagnostic Test|Observer's Assessment of Alertness/Sedation Scale|Patients' sufficient wakefulness was evaluated by Observer's Assessment of Alertness/Sedation scale in the recovery unit.
15789335|NCT04538300|Diagnostic Test|Patient Satisfaction|Patient satisfaction was questioned. Answers were recorded as one of the choices (never, sometimes, usually or always)
15789336|NCT04538300|Diagnostic Test|Surgeon Satisfaction|Surgeon satisfaction was questioned. Answers were recorded as one of the choices (never, sometimes, usually or always)
15789337|NCT04538300|Other|Chewing Peppermint gum|Peppermint gum was chewed for 15 minutes in patients with sufficient wakefullness.
15789338|NCT04538287|Device|AtaCor StealthTrac Lead|Subjects are assigned non-randomly to receive one of the four AtaCor StealthTrac leads being evaluated in the study.
15789339|NCT04538274|Behavioral|peer-driven intervention|Trained patient researchers will conduct 3 motivational sessions, according to the principle of motivational enhancement and cognitive-behavioral therapies, by videoconference meetings of 45 to 60 minutes duration with 5 to 8 patients within 6 months after each patient's inclusion.
15789340|NCT04538261|Device|Fetal Pillow insertion|Inflation of balloon device used to elevate fetal buttocks prior to performing external cephalic version procedure
15789341|NCT04538248|Other|Combined rehabilitation during hemodialysis|Combined rehabilitation during hemodialysis
15789342|NCT04538235|Procedure|Thoracic Regional Analgesia|In the TEA group, a thoracic epidural was performed before VATS. In the Bi-block group, a SAP block associated with an ESP block were performed before surgical incision under general anesthesia.
15789343|NCT04538222|Other|physical activity|aerobic exercise, muscle strength and stretching, nutrition education
15789344|NCT04538209|Radiation|Abdominal computed tomography with angiography.|technique of combing a Computed Tomography scan with the injection of dye to create pictures of the portal circulation and portosystemic collaterals veins.
15789345|NCT04538196|Other|Resident education on documentation and coding|Surgery residents will receive education on documentation and coding at the beginning of a particular surgical rotation vs the control group who will receive no education on documentation
15789346|NCT04538183|Other|WO 5000|WO 5000
15789347|NCT04538183|Other|WO 5001|WO 5001
15789348|NCT04538170|Behavioral|pain after surgery|
15789349|NCT04538157|Other|Comprehensive Geriatric Assessment|A CGA is a diagnostic and therapeutic intervention which initially identifies an older person's medical, functional, psychosocial problems and then tailors coordinated management plans to address them.
15789350|NCT04538144|Other|Simulated heat wave|Individuals will be exposed to thermoneutral climate conditions and two simulated heat wave conditions.
15789351|NCT04538131|Device|sensor-driven position-adaptive SCS|Medtronic sensor-driven position-adaptive SCS is capable to monitor the position change and change the parameters accordingly, so as to reduce the position change related side effects.
15789352|NCT04538131|Device|conventional SCS|Conventional SCS can not change the parameter when the body position changes.
15789353|NCT04538118|Behavioral|Shoulder disability|"Shoulder disability was evaluated with Patient-specific functional scale, the disabilities of the shoulder, arm and hand questionnaire, and the upper extremity functional index.
~First assessment was applied when patients came to physical therapy clinic at first.
~Second assessment was repeated after 6 weeks."
15789354|NCT04538118|Device|Shoulder Range of Motion|"Shoulder range of motion was evaluated with universal goniometer. First assessment was applied when patients came to physical therapy clinic at first.
~Second assessment was repeated after 6 weeks."
15789355|NCT04538118|Behavioral|Pain Intensity|"Pain intensity was evaluated with Numeric Pain Rating Scale. First assessment was applied when patients came to physical therapy clinic at first.
~Second assessment was repeated after 6 weeks."
15789356|NCT04538105|Other|Control|Saline Articular Nerve Branch Block
15789357|NCT04538105|Other|Articular Branch Block (ABB)|0.5% Bupivacaine with epinephrine 1:200,000 (Articular Branch Block)
15789358|NCT04538092|Other|Enhanced Recovery After Surgery Protocol|The investigators have developed an Enhanced Recovery After Surgery protocol for complex spine surgery at UNC. This study will help elucidate the effects of multiple interventions tailored to help patients recover from complex surgery.
15789359|NCT04538079|Device|Multimodal objective non-invasive Monitoring|Multimodal objective non-invasive monitoring including cerebral oxygenation (NIRS), pulse oximetry with Pulsatility Index (PI) and non-invasive Cardiac Output Monitoring will be recorded but not used for clinical decision making. 2 ECHOs will be performed (one within the first 24h, one in the 2nd 24 hours after birth)
15789360|NCT04538066|Drug|Bryostatin 1|Bryostatin 20 micrograms administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks, followed by a second identical course of treatment beginning 30 days after completion of the first 7-dose course.
15789361|NCT04538066|Other|Placebo|Placebo administered IV over 45 minutes every other week after 2 initial loading doses of 24 micrograms administered weekly. A total of 7 doses administered over 12 weeks, followed by a second identical course of treatment beginning 30 days after completion of the first 7-dose course.
15789362|NCT04538053|Drug|Oral cefalexin only|High-dose oral cefalexin
15789363|NCT04538053|Drug|IV cefazolin followed by oral cefalexin|Standard therapy of IV cefazolin followed by high dose oral cefalexin
15789364|NCT04538040|Drug|Bictegravir/emtricitabine/tenofovir alafenamide + Doravirine switch|Safety and efficacy of switching from rilpivirine/emtricitabine/tenofovir alafenamide in combination with dolutegravir, to bictegravir/emtricitabine/tenofovir alafenamide in combination with doravirine in male, 45+ year old subjects. The study will also include secondary outcomes of quality of life (QOL) and weight changes.
15789365|NCT04538027|Procedure|Lumbar Microdiscectomy at 6 weeks of symptoms|Microscope assisted lumbar discectomy done at 6 weeks of starting symptoms
15789366|NCT04538027|Procedure|Lumbar Microdiscectomy at 3 months of symptoms|Microscope assisted lumbar discectomy done at 3 months of starting symptoms
15789367|NCT04538027|Procedure|Lumbar Microdiscectomy at 6 months of symptoms|Microscope assisted lumbar discectomy done at 6 months of starting symptoms
15789368|NCT04538014|Drug|Lu AF88434|Oral solution
15789369|NCT04538014|Drug|[11C]-Lu AF88434|[11C]-Lu AF88434, and a radioactive dose not exceeding 400 MBq at each PET examination, intravenous bolus injection
15789370|NCT04538001|Device|Balloon implantation|Subjects will undergo arthroscopic surgical intervention of debridement, long head of biceps tenotomy if deemed necessary with or without acromioplasty, and balloon implantation.
15789371|NCT04538001|Procedure|Rotator cuff repair|Subjects will undergo arthroscopic surgical intervention of debridement, long head of biceps tenotomy if deemed necessary with or without acromioplasty, and partial repair
15789372|NCT04537988|Other|Behavioral: eCHANGE|eCHANGE is an eHealth intervention aiming to support long-term weight maintenance after initial weight loss
15789373|NCT04537975|Device|C2Rx|Hemofiltration
15789374|NCT04537975|Other|Standard of Care (SOC)|Standard of care that excludes any protocol restrictions.
15789375|NCT04537962|Other|Colgate Periogard® mouthwash|Patients will be submitted to antisepsia of the oral mucosa with Colgate Periogard® mouthwash
15789376|NCT04537962|Other|Colgate Peroxyl® mouthwash|Patients will be submitted to antisepsia of the oral mucosa with Colgate Peroxyl® mouthwash
15789377|NCT04537962|Other|Colgate Total® Mouthwash|Patients will be submitted to antisepsia of the oral mucosa with Colgate Total® Mouthwash
15789378|NCT04537962|Other|Toothpaste with sodium monofluorophosphate|Patients will be submitted to brushing with toothpaste with sodium monofluorophosphate
15789379|NCT04537962|Other|Toothpaste with sodium fluoride and zinc|Patients will be submitted to brushing with toothpaste with sodium fluoride and zinc
15789380|NCT04537962|Other|Toothpaste with tin fluoride|Patients will be submitted to brushing with toothpaste with tin fluoride
15789381|NCT04537949|Biological|BNT162b3|Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection (Prime/Boost (P/B) regimen).
15789382|NCT04537936|Behavioral|Meaning Centered Psychotherapy for Latinos|MCP-L consists of seven-60 minute-individual sessions. The seven sessions are expected to be delivered every week or every two weeks over a span of 7-14 weeks.
15789383|NCT04537936|Behavioral|Functional Assessment of Cancer Therapy - Spiritual Well-Being Scale|Determines the degree of spiritual well-being
15789384|NCT04537936|Behavioral|Meaning Centered Psychotherapy for Latinos for Waitlist Control Patients|Waitlist Control Patients in the control condition will be allocated to a waitlist group to receive the intervention approximately three months after randomization.
15789385|NCT04537936|Behavioral|Pre-assessment questionnaire|Which includes 10 standardized scales Assessment/Evaluation Plan, Phase 1, 4 - Quantitative Measure Questionnaire).The interview guide will inquire about the comprehension and acceptability of, and alternative options for, these intervention components.
15789389|NCT04537910|Drug|LY3819253|Administered SC.
15789390|NCT04537910|Drug|Placebo|Administered SC.
15789395|NCT04537871|Procedure|Bioelectric Impedance Analysis|Undergo bioelectric impedance analysis
15789396|NCT04537871|Procedure|Biospecimen Collection|Undergo collection of blood samples
15789397|NCT04537871|Procedure|Cardiopulmonary Exercise Testing|Undergo cardiopulmonary exercise test
15789398|NCT04537871|Procedure|Echocardiography|Undergo echocardiogram
15789399|NCT04537871|Procedure|Physical Performance Testing|Undergo physical function tests
15789400|NCT04537871|Procedure|Pulmonary Function Test|Undergo pulmonary function test
15789401|NCT04537871|Other|Questionnaire Administration|Ancillary studies
15789402|NCT04537871|Procedure|Ultrasound|Undergo musculoskeletal ultrasound
15789403|NCT04537858|Device|Virtual reality therapy first|First day of the protocol with Virtual Reality intervention in the morning and conventional intervention in the afternoon
15789404|NCT04537858|Device|Conventional therapy first|First day of the protocol with conventional intervention in the morning and Virtual Reality intervention in the afternoon
15789405|NCT04537832|Other|No Intervention|No Intervention
15789406|NCT04537819|Drug|Imupret in addition to local NAID|Additional prescription of Imupret oral drops to conventional therapy with local NAID (Benzydamine hydrochloridy), elimination of irritating factors in the diet and acetaminophen (if necessary)
15789407|NCT04537819|Drug|Local NAID (Benzydamin)|(Benzydamine hydrochloridy) and acetaminophen (if necessary), elimination of irritating factors in the diet
15789408|NCT04537806|Drug|Brexanolone|Brexanolone, intravenous (IV) infusion.
15789409|NCT04537806|Drug|Placebo|Placebo, IV infusion.
15789410|NCT04537793|Drug|ELX/TEZ/IVA|Fixed dose combination granules for oral administration.
15789411|NCT04537793|Drug|IVA|Granules for oral administration.
15789412|NCT04537780|Other|Placebo|Placebo tabled every day
15789413|NCT04537780|Drug|Montelukast|Montelukast 10 mg daily at bed time.
15789414|NCT04537767|Drug|Esmolol|The protocol required a titrated esmolol infusion commenced at 25 mg/ h, with an upper dose limit of 2000 mg/h, to maintain the HR between 75 and 90 bpm in ES group. The control group were treated with placebo.
15789415|NCT04537767|Drug|Placebo|Placebo
15789416|NCT04537754|Device|bleaching device|activated bleaching
15789417|NCT04537741|Procedure|Coronary CT angiography|all patients being included will undergo CCTA before invasive coronary angiography
15789418|NCT04537741|Procedure|Invasive coronary angiography|all patients being included will undergo CCTA before invasive coronary angiography
15789419|NCT04537728|Behavioral|My Healthy Brain Version 2|multimodal lifestyle intervention incorporating mindfulness skills, behavioral principles, and recent research on brain disease risk factors
15789420|NCT04537715|Drug|Tazemetostat|Physical description: Red, round, and biconvex film-coated tablets packaged in white high-density polyethylene bottle with a child resistant, tamper-evident polypropylene screw cap.
15789477|NCT04537208|Biological|SARS-CoV-2 vaccine formulation 2 with adjuvant 1|Pharmaceutical form: liquid; route of administration: intramuscular injection
15789421|NCT04537715|Drug|Itraconazole|"Information regarding brand itraconazole (Sporanox) is provided here as an example only. During this study, the use of either brand or generic forms of itraconazole is acceptable. Please refer to manufacturer's prescribing information for drug form selected prior to administration.
~Dosage form: 100 mg capsule
~Physical description: Capsules contain itraconazole-coated sugar spheres within a blue opaque cap and pink transparent body, imprinted with JANSSEN and SPORANOX 100, supplied in unit-dose blister packs of 3 × 10 capsules, bottles of 30 capsules, or in the PulsePak® containing 7 blister packs × 4 capsules each."
15789422|NCT04537715|Drug|Rifampin|"Information regarding brand rifampin (Rifadin) is provided here as an example only. During this study, the use of either brand or generic forms of rifampin is acceptable. Please refer to manufacturer's prescribing information for drug form selected prior to administration.
~Dosage form: 150 mg and 300 mg capsules
~Physical description: 150 mg maroon and scarlet capsules imprinted RIFADIN 150 in bottles of 30. 300 mg maroon and scarlet capsules imprinted RIFADIN 300 in bottles of 60."
15789423|NCT04537702|Behavioral|Streamlined Education|After completion of the baseline surveys, the SG subjects will watch an approximately eight minute long genetics education video. This video will be made with the assistance of Duke University genetic counselors and gynecologic oncology providers. It will consist of a discussion of genes and mutations, the recommendation of universal testing for high grade epithelial ovarian cancer, a review of genes associated with ovarian cancer predisposition, the possibility of uncertain results including variants of undetermined significance, the potential for undetected mutations in known or unknown cancer susceptibility genes, the potential impact on personal treatment and on family members, the possibility of genetic discrimination and the legal protection of genetic information.
15789424|NCT04537702|Behavioral|Traditional Education|The TG subjects will then meet with the genetic counselor at the previously scheduled appointment time. During this visit, they will receive approximately thirty to sixty minutes of counseling regarding genetic testing and potential results. The discussion is based on the American Society of Clinical Oncology (ASCO) and National Comprehensive Cancer Network (NCCN) guidelines of informed consent for genetic testing. After counseling, participants will be given the option to undergo a multi-gene panel genetic test either via saliva or blood sample. Those who agree to testing will also complete the standard genetic testing consent form. As per standard practice of the clinical genetic service at DCI, patients will also be asked to provide consent for somatic tumor testing of surgical specimen (non-cytologic).
15789425|NCT04537689|Biological|Ixekizumab|Ixekizumab for 6 months, given 160mg at weeks 0, followed by 80mg at 2, 4, 6, 8, 10 and 12, then 4 weekly till 6 months. Given subcutaneously.
15789426|NCT04537689|Drug|Methotrexate|Oral tablet up to 15mg per week
15789427|NCT04537689|Drug|Cyclosporin A|Oral capsule up to 200mg per day
15789428|NCT04537689|Drug|Acitretin|Oral capsule up to 25mg per day
15789429|NCT04537676|Other|No intervention, this is an observational study|No intervention
15789430|NCT04537663|Drug|Bacille Calmette-Guérin (BCG)|Participants in the intervention group will be vaccinated with the licensed BCG vaccine (Danish strain 1331, SSI, Denmark) using the standard vaccination technique for this vaccine (intradermal injection in the left upper arm).
15789431|NCT04537663|Drug|Placebo|Intradermal injection of sterile 0.9% NaCl.
15789432|NCT04537650|Diagnostic Test|Videofluoroscopic Swallowing Study (VFSS)|A standardized dynamic radiographic examination of oropharyngeal swallowing
15789433|NCT04537637|Drug|Oral Semaglutide|Patients will be treated with commercially available oral semaglutide according to local label and to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available oral semaglutide has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician based on local label before and independently from the decision to include the patient in this study.
15789435|NCT04537611|Diagnostic Test|dHb contrast and gadolinium contrast imaging|see arm description
15789436|NCT04537598|Procedure|Morphine patient controlled analgesia|30 patients will receive PCA only for postoperative analgesia
15789437|NCT04537598|Procedure|Morphine patient controlled analgesia and ESPB|30 patients will receive PCA in addition to ESPB for postoperative analgesia
15789438|NCT04537585|Combination Product|Tomeka®|Tomeka® is a farine mixte made by soy, sorghum, maze and mushrooms
15789439|NCT04537585|Drug|"Vernonia amygdalina"|"Vernonia amygdalina is the Intervention that was pre-specified to be administered as part of the protocol as a particular intervention of not of interest because the World Health Organization doesn't support its use due to two reports case of toxicity in Kinshasa in a child and Mbandaka in an adult in the Democratic Republic of the Congo that why investigators would like review its usage in a large community and update that intervention of not of interest as appropriate (using randomisation on the follow up of participants who will take by themselves those herbs called Congo Bololo to compare, as necessary, to the ones who are afraid to take them because of reported cases of toxicity)."
15789440|NCT04537572|Diagnostic Test|comparison of sample collection methods|Samples will be collected via finger-stick, saliva collection, and traditional phlebotomy to determine effects on COVID-19 antibody test results.
15789441|NCT04537546|Device|OBESINOV elasto-compressive belt|It is a customised medical device, using a technique for calculating the compression ratio adapted to each patient according to his morphology
15789442|NCT04537533|Drug|Tranexamic acid|Intraoperative infusion
15789443|NCT04537533|Other|Normal saline|intravenous infusion
15789444|NCT04537520|Device|Kerecis Omega3 Wound|Treatment of the wound with Kerecis Omega3 Wounds matrices
15789445|NCT04537507|Procedure|Coronary angiography|
15789446|NCT04537494|Dietary Supplement|L. reuteri|Probiotic
15789447|NCT04537481|Other|Lipid extraction|The sperm samples were used for lipid extraction. Lipids were analyzed using the UPLC-MS system.
15789478|NCT04537208|Biological|SARS-CoV-2 vaccine formulation 2 with adjuvant 2|Pharmaceutical form: liquid; route of administration: intramuscular injection
15790693|NCT04527458|Other|COVID-19 treatments|Specific treatments used on COVID-19 patients
15789448|NCT04537468|Other|Skin squame collection|Subjects underwent skin squame collection by scraping. The investigator gently scraped the surface of a lesional skin area for patients with psoriasis, and of a non-lesional skin area for healthy volunteers to collect superficial cells. These samples were analyzed by gene expression analyses.
15789449|NCT04537468|Other|Tape strip collection|The first subjects had up to 35 tape strips from a maximum of 4 areas (4 X 35 strippings) on the trunk or limbs (excluding the genital area). Patients with atopic dermatitis or psoriasis had tape stripping performed on lesional skin areas and the control subjects had tape stripping performed on nonlesional skin areas. The next subjects were used to determine the optimal number of tape strips required to obtain a good signal by gene expression analyses.
15789450|NCT04537468|Other|Tape strip and skin biopsy collection|Subjects had tape stripping on up to 3 different skin areas (2 areas on lesional skin and one area of nonlesional skin for patients with atopic dermatitis or psoriasis, and 2 areas of healthy skin for control subjects) using the optimal number of tape strips, as determined in the previous part. One 4-mm skin biopsy on a tape stripped area plus one 4-mm biopsy on non-tape-stripped skin (2 biopsies per subject) were also collected.
15789451|NCT04537455|Diagnostic Test|Ultra-high frequency electrocardiography|Patients will have an ultra-high frequency electrocardiography performed.
15789452|NCT04537442|Drug|IM21 CAR-T cells|"IM21 CAR-T cells
~Drug: Fludarabine
~Two days before cell infusion, all patients will be treated with fludarabine for 3 days
~Drug: Cyclophosphamide
~Two days before cell infusion, all patients will be treated with Cyclophosphamide for 3 days
~Other Names:
~Fludarabine Cyclophosphamide"
15789453|NCT04537429|Drug|Eptinezumab|up to four iv infusions of eptinezumab
15789454|NCT04537416|Other|No intervention|No intervention
15789455|NCT04537403|Drug|Group 1-64CU-DOTA-ECL1i (radioactive imaging medicine)|Patients in Group 1, normal volunteers and patients with carotid and femoral artery disease who will be having surgery, will have a 1 day imaging session lasting approximately 60 minutes with an injection of 64CU-DOTA-ECL1i to visualize the carotid and femoral arteries. Patients with carotid and femoral artery disease will have their plaque specimens collected for further sutdy
15789456|NCT04537403|Drug|Group 2 64CU-DOTA-ECL1i (radioactive imaging medicine)|Patients in Group 2, who are patients with carotid and femoral artery disease who will not be having surgery will have two imaging sessions 7-14 days apart
15789457|NCT04537390|Diagnostic Test|Blood sample collection|Blood samples are collected for diagnostically assessing how the blood AMH levels correspond to a female's reproductive development
15789458|NCT04537377|Genetic|VTX-801|"The investigational medicinal product (VTX-801) is a replication-deficient recombinant adeno-associated viral vector (rAAV) consisting of an AAV liver tropic capsid containing a single-stranded DNA genome carrying a shortened version of the ATP7B gene (ATP7B-minigene).
~After reconstitution VTX-801 will be administered as a single dose intravenous (IV) administration per patient, at up to 3 different dose levels."
15789459|NCT04537364|Diagnostic Test|combined diagnosis of renal parenchymal damage|"This study is an observational study to evaluate the accuracy of renal parenchymal damage combined diagnosis with no intervention. All patients from the cohort accept MRI-DWI scan，the urinary biomarkers detection, disease gene detection and DMSA scan.
~This combined diagnosis includes MRI-DWI scan and the urinary biomarkers detection.
~MRI-DWI： All the scans are performed using the MagnetomVerio 3.0T magnetic resonance imaging system from Siemens.
~Urinary polypeptide collection: Urine samples requirements: volume between 50-100ml, specific gravity >1.010. Immunomagnetic beads isolation technique is used to collect polypeptide.
~The reference standard is DMSA scan: Intravenous injection of 99mTC-DMSA5mCi is followed by anterior and posterior planar imaging of the renal area 1 hour later. The DMSA scan images are read by 2 trained radiologists and confirmed by the special doctor of the center for diagnosis and treatment of renal and urinary diseases at the same time."
15789460|NCT04537351|Biological|CYP-001|The active agent in CYP-001 is Cymerus mesenchymal stem cells (MSCs), which are derived through a proprietary induced pluripotent stem cell (iPSC) and mesenchymoangioblast (MCA)-derived production process.
15789461|NCT04537338|Genetic|1. Characterize the immune response after infection with SARS-CoV-2|1. Characterize the immune response after infection with SARS-CoV-2 in terms of type of antibodies (IgM, IgG, IgA), seroconversion, maximum antibody levels, , and response to different viral proteins/antigens
15789462|NCT04537325|Device|RenalGuard system|Periprocedural intravenous hydration matched to urinary output.
15789463|NCT04537312|Procedure|Robot-assisted Nipple Sparing Mastectomy|Under RNSM
15789464|NCT04537312|Other|Survey Administration|ancillary correlative
15789465|NCT04537312|Device|RNSM|Robot-assisted Nipple Sparing Mastectomy
15789466|NCT04537299|Drug|Fisetin|~20 mg/kg/day oral, NG or D tube course for 2 consecutive days twice (Days 0 & 1 and Days 8 & 9)
15789467|NCT04537299|Drug|Placebo|Placebo looks exactly like the treatment drug, but it contains no active ingredient
15789468|NCT04537286|Drug|nab-paclitaxel plus cisplatin plus carilizumab (AP+PD-1)|Nab-paclitaxel 125 mg/m2，ivgtt，d1, 8 Cisplatin 75 mg/m2，ivgtt，d1 Carilizumab 200mg, ivgtt，d1，q2w
15789469|NCT04537273|Other|Descriptive and analytical|
15789470|NCT04537260|Behavioral|Educational Video|Those in the intervention arm were asked to watch the 3-minute educational video prior to the knowledge questionnaire and meeting their provider (midwife or obstetrician). The video shown to these participants is linked here: https://youtu.be/Pc9tcIV4Dm8.
15789471|NCT04537247|Procedure|partial nephrectomy for complex renal tumor|removal of tumor with sufficient safety margin with preservation of functioning renal unit (renal tissue with its collecting system, arterial supply and venous as well as lymphatic drainage).
15789472|NCT04537234|Biological|Quadrivalent Influenza Vaccine (split virion, inactivated) High-Dose (QIV-HD)|Pharmaceutical form:Suspension for injection in pre-filled syringe Route of administration: Intramuscular
15789473|NCT04537234|Biological|Quadrivalent Influenza Vaccine (split virion) Standard-Dose (AdimFlu-S (QIV-SD))|Pharmaceutical form:Suspension for injection in pre-filled syringe Route of administration: Intramuscular
15789474|NCT04537221|Biological|Blood transfusion|Transfusion of red blood cells peri-operatively
15789475|NCT04537208|Biological|SARS-CoV-2 vaccine formulation 1 with adjuvant 1|Pharmaceutical form: liquid; route of administration: intramuscular injection
15789476|NCT04537208|Biological|SARS-CoV-2 vaccine formulation 1 with adjuvant 2|Pharmaceutical form: liquid; route of administration: intramuscular injection
15790694|NCT04527458|Other|Differences in triage|Triage criteria for treating COVID-19 patients
15789479|NCT04537208|Biological|SARS-CoV-2 vaccine formulation 2 without adjuvant|Pharmaceutical form: liquid; route of administration: intramuscular injection
15789480|NCT04537208|Biological|Placebo (0.9% normal saline)|Pharmaceutical form: liquid; route of administration: intramuscular injection
15789481|NCT04537195|Behavioral|ADSMP-C|A transdiagnostic, lay-led, group-based self-management program consisting of seven 2 ½ hour weekly sessions focusing on increasing patient self-efficacy in symptom management of anxiety and depression in cancer (ADSMP-C)
15789482|NCT04537182|Procedure|Lung volume reduction surgery|Lung volume reduction by surgery
15789483|NCT04537182|Procedure|Bronchoscopic lung volume reduction with valves|Lung volume reduction with endobronchial valves.
15789484|NCT04537169|Procedure|Levator resection|Eyelid crease incision Dissection of the levator aponeurosis to the level of Whitnall ligament. Assessment of the structure of Whitnal ligament. Resection of a calculated part of the aponsurosis. re-attachment of the aponeurosis to the tarsus Incision closure with crease formation
15789485|NCT04537156|Biological|Nonavalent HPV vaccine|Nonavalent HPV vaccine (270μg/0.5ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
15789486|NCT04537156|Biological|Bivalent HPV vaccine|Bivalent HPV vaccine (60μg/0.5ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
15789487|NCT04537130|Biological|IN01 vaccine|"INO1 vaccine is a biological compound comprising generated and purified from recombinant bacteria culture that contains a protein consisting of EGF-4-EGF portion and the Cholera Toxin B-Subunit Domain G33D sequence (CTB-G33D) separated by 4 amino acids and 14 amino acids respectively glycine/serine-rich linkers.
~IN01 is a recombinant growth factor fusion molecule which, once injected into the patient, stimulates the immune system to produce polyclonal anti-Epidermal Growth Factor (anti-EGF) neutralizing antibodies. This vaccine-led active immunisation is a new approach to target the growth factor pathways allowing for combinations with other small molecule inhibitors in order to obtain a sustained efficacy with an acceptable toxicity.
~The vaccine inhibits binding of circulating Epidermal Growth Factor (EGF) to its receptor, EGF-R to block downstream activation of cell signaling pathways contributing to tumor growth or other pathophysiologies such as fibrosis."
15789488|NCT04537117|Other|Questionaire|Questionnaire addressing pediatric dentists behaviors and practices during the COVID-19 pandemic
15789489|NCT04537104|Device|Coala Heart Monitor|ECG monitoring
15789490|NCT04537091|Procedure|rESWT|rESWT was administered once per week for 3 weeks with 4 bar pneumatic pressure, 10 Hz frequency, with 2000 pulses. Radial shock waves were transmitted to the greater trochanteric region with the maximum pain/tenderness that was identified with patients' reaction with small circular movements with an adequate amount of contact gel
15789491|NCT04537091|Procedure|PRP injection|PRP injection is performed with a high resolution 7-12-megahertz linear probe ultrasonography device. 15 ml of blood will be drawn from the patients and the blood will be centrifuged for 5 minutes. 4-5 ml PRP will be injected into the affected gluteal tendons accompanied by ultrasonography.
15789492|NCT04537078|Drug|Duphaston|will be used for pituitary suppression in the first arm:20 mg/day will be started from the first day of the ovulation induction in the follicular phase and in the luteal phase will be started the next day after oocyte pickup at 20 mg/day.
15789493|NCT04537078|Drug|Gonadotropin|will be used for controlled ovarian hyperstimulation in both arms
15789494|NCT04537078|Drug|Cetrotide Injectable Product|will used in the second arm for pituitary suppression in the second group daily when the biggest oocyte reaches size 14 mm till ovulation triggering
15789495|NCT04537078|Drug|Decapeptyl|will be used for ovulation triggering.in the first arm:in a dose of 2 ampules of 0.2 mg will be administered when leading follicle >18 mm in diameter. in the second arm:in a dose of 2 ampules 0.2 mg will be administered when leading follicle >18 mm in diameter in the first cycle only.
15789496|NCT04537078|Drug|Chorionic Gonadotropin|will be used in the second cycle of the second arm for ovulation triggering in a dose of 10,000 IU when the leading follicle >18 mm in diameter.
15789497|NCT04537078|Drug|Combined Oral Contraceptive|luteal phase priming from day 21 of the cycle before controlled ovarian stimulation for one week .
15789498|NCT04537078|Drug|Cyclo-Progynova|Starting from cycle Day 3 of the intented cycle for thawed embryo transfer, patients will receive the white tablets of Cyclo-Progynova daily. From Day 10 onwards, endometrium growth will be monitored by transvaginal ultrasound.
15789499|NCT04537078|Drug|progesterone|in the intended cycle of embryo transfer when endometrial thickness ≥ 7 mm. Progesterone administration (as 800 mg/day vaginal suppositories per day and 100 mg ampule IM every other day) will be continued until pregnancy testing 18 days after embryo transfer and in pregnant cases will continued till the 12 weeks of gestation.
15789500|NCT04537065|Other|cycloplegic refraction|"Cycloplegic refraction and the average corneal radius of curvature were performed using a handheld auto kerato-refractometer (Righton Retinomax K-plus2). Refraction was confirmed by retinoscopy and refractive errors were calculated as spherical equivalent and astigmatism in cylinder.
~The biometric optic components, including anterior chamber depth, lens thickness, and axial length, were measured using A-scan ultrasound (model Echoscan US-4000 / 500; Nidek)."
15789501|NCT04537052|Procedure|Ven Restoration Therapy|This is a novel and promising method, applied percutaneously, in the treatment of deep venous insufficiency . In this method, developed based on the effects of compression garments, a polymer consisting of cyanoacrylate and hyaluronic acid is injected, with ultrasound-guidance, percutaneously around the femoral vein. In this way, the diameter of the vein is reduced, and function is restored to the inadequately functioning valve. The procedure is also called percutaneous valvuloplasty. The underlying idea in the development of this product was that hyaluronic acid might cause an increase in connective tissue, while cyanoacrylate could serve as an exoskeleton by forming heavy tissue.
15789502|NCT04537039|Diagnostic Test|Frailty screening for people over 65 living at home.|The home care services will carry out the SEGA-A test.
15789503|NCT04537026|Drug|Amniotic Fluid Allograft|Amniotic Fluid Allograft will be mixed with sterile water and injected using transforaminal approach
15789504|NCT04537026|Drug|Dexamethasone sodium phosphate|Dexamethasone phosphate mixed with sterile water will be injected by transforaminal approach
15789505|NCT04537013|Procedure|Microfracture|Debridement of cartilage followed by placement of small holes in the effected area to fill the debrided area with marrow and cells.
15789541|NCT04536805|Radiation|Stereotactic Body Radiation Therapy (SBRT) 36 Gy|Stereotactic Body Radiation Therapy (SBRT): Dose escalation 6 x 6 Gy day 0 to day 12
15789506|NCT04537013|Device|Microfracture plus placement of Chondro-Gide® ACC|Debridement of cartilage followed by placement of small holes in the effected area to fill the debrided area with marrow and cells, followed by affixing Chondro-Gide® with fibrin glue.
15789507|NCT04537000|Diagnostic Test|clinical condition score|A score is firstly identified using a clinical condition scale including the concentration of inspired oxygen to maintain the percutaneous oxygen saturation (SPO2)≧95%, the fusion rate of catecholamine drugs to maintain normal blood pressure, the nasopharyngeal temperature and the oxygen saturation of central venous blood. The score was graded as 0, 1 and 2 points according to the patient's clinical condition. The score identified from the scale plus 7 finally makes the clinical condition score. If the score is higher than 10, it will be replaced with 10. That is to say, the highest clinical condition score is 10. If the clinical condition score≦Hb, blood red cell transfusion will not be started. If the clinical condition score>Hb, blood red cell transfusion will be started, and the volume will be calculated using the following formulation, transfusion volume(ml)=(clinical condition score - Hb)*body weight *5.
15789508|NCT04536987|Device|HEXORR|The subject receives robotic assistance from the HEXORR robot during finger and thumb movements. Several different video games are used to provide feedback of performance and motivate the training. The assistance level is adjusted automatically in some games and manually in other games to enable a target success rate of 67% when playing the games.
15789509|NCT04536974|Diagnostic Test|SEFI tool|Detect the risk of malnutrition with the SEFI tool
15789510|NCT04536961|Drug|Reference Treatment- BMS-986165-01|Specified dose on specified days
15789511|NCT04536961|Drug|Prototype BMS-986165|Specified dose on specified days
15789512|NCT04536961|Drug|Famotidine|Specified dose on specified days
15789513|NCT04536961|Other|Alcohol|Specified quantity on specified days
15789514|NCT04536948|Other|Cooling Gel|Cooling gel (Nelsons Arnicare Arnica Cooling Gel) was applied to the lateral epicondyle region with sponge head 3 times a day. The cooling gel was applied to the painful area around the lateral epicondyle
15789515|NCT04536948|Other|Cold Pack|Cold pack was applied to the painful area for 15 minutes on a moist towel placed on the painful area around the lateral epicondyle.
15789516|NCT04536935|Behavioral|Mobile Mental Health App - 1|Free mobile application that addresses mental health issues
15789517|NCT04536935|Behavioral|Mobile Mental Health App - 2|Free mobile application that addresses mental health issues
15789518|NCT04536935|Behavioral|Mobile Mental Health App - 3|Free mobile application that addresses mental health issues
15789519|NCT04536935|Behavioral|Mobile Mental Health App - 4|Free mobile application that addresses mental health issues
15789520|NCT04536922|Drug|Cyclophosphamide|Days -7 and -6: Cyclophosphamide 60 mg/kg/day x 2 days IV in 250 mL D5W infused simultaneously with mesna 15 mg/kg /day over 1 hour x 2 days.
15789521|NCT04536922|Drug|Fludarabine|Days -7 to -3: Fludarabine 25 mg /m2/day IVPB daily over 30 minutes for 5 days.
15789522|NCT04536922|Drug|Aldesleukin|Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 4 days (maximum 10 doses).
15789523|NCT04536922|Drug|Pembrolizumab (KEYTRUDA(R))|Pembrolizumab 2 mg /kg IV over approximately 30 minutes on Days -2, 21, 42, and 63.
15789524|NCT04536922|Biological|Individual Patient TCR-Transduced PBL|Day 0: Cells will be infused at a dose not to exceed 1.5e11 in 400 mL intravenously on the Patient Care Unit over 20-30 minutes (2-4 days after the last dose of fludarabine).
15789525|NCT04536909|Other|Non-surgical|We have constructed a training program with help from physiotherapists from Rikshospitalet in Oslo, tailored for kyphotic- and scoliotic patients.
15789526|NCT04536909|Procedure|Surgical|Surgery for correction of kyphotic- or scoliotic deformity.
15789527|NCT04536896|Other|Smartphone breastfeeding application|This intervention consists of a smartphone application which contains relevant information and topics regarding proper breastfeeding knowledge for medical students.
15789528|NCT04536896|Other|Traditional face-to-face breastfeeding lecture|This intervention consists of the impartition of a face-to-face breastfeeding course
15789529|NCT04536883|Procedure|microscopy confocal|"At this stage, the confocal microscopy procedure begins:
~Taking pictures for post-procedure analysis in 4 different territories. For each territory, the investigator need to get a snapshot of a vascular structure and a snapshot of an alveolus.
~Analysis per procedure: the same operator analyzes the alveoli deemed to be representative in real time. It determines the presence of intra-alveolar inflammatory cells and answers the question of the main criterion: possible interpretation in confocal microscopy? YES / NO, the clinical researcher immediately notes the answer in the CRF. Based on this per-procedure analysis, if he deems the interpretation possible, the operator declares if he concludes that pulmonary inflammation is present YES / NO, the response is noted immediately in the CRF.
~The fibroscopy procedure is then resumed as usual in the department, namely:"
15789530|NCT04536870|Diagnostic Test|Echocardiography|Ultrasound of heart
15789531|NCT04536870|Diagnostic Test|ECG screening|Single lead ECG screening twice daily for two weeks
15789532|NCT04536870|Diagnostic Test|ECG Screening|12-lead ECG screening
15789533|NCT04536857|Other|Biomarker assay|Biomarker assay will be used to quantify levels of misfolded alpha-synuclein aggregates in cerebrospinal fluid from patients with Parkinson's disease, multiple system atrophy, progressive superanuclear palsy and controls.
15789534|NCT04536844|Device|Mobile application MyDignio (follow disease activity by assigning questionnaires to participants)|An electronic application available both on Apple store and Android play which the patients can download for free will be used to collect data from the Telehealth follow up group. This group will be compared to conventional outpatient clinic follow-up group.
15789535|NCT04536844|Other|Conventional prescheduled follow-up|Patients will be followed in the outpatient clinic by prescheduled follow-up
15789536|NCT04536831|Drug|Vitamin D|Vitamin D will be given to group A selected by Lottery method
15789537|NCT04536831|Drug|Normal saline|Vitamin D will be given to group B slected by Lottery method
15789538|NCT04536818|Procedure|Laparotomy|Exploratory laparotomy.
15789539|NCT04536805|Drug|Metformin|Metformin: 850 mg per day (day -15 to day 0) 1700 mg per day (day 1 to day 75)
15789540|NCT04536805|Radiation|Stereotactic Body Radiation Therapy (SBRT) 30 Gray (Gy)|Stereotactic Body Radiation Therapy (SBRT): Dose escalation 5 x 6 Gy day 0 to day 10
15789542|NCT04536805|Radiation|Stereotactic Body Radiation Therapy (SBRT) 25 Gy|Stereotactic Body Radiation Therapy (SBRT): Dose escalation 5x 5 Gy day 0 to day 10
15789543|NCT04536792|Drug|AG-946|AG-946, oral encapsulated coated-granules or tablets.
15789544|NCT04536792|Drug|AG-946 Matched Placebo|AG-946 matched-placebo, oral encapsulated sugar spheres or tablets.
15789545|NCT04536779|Other|Training in the local departments of TT and cycling trips with CUA|in a minimum of 3 months, the individuals with low physical mobility will conduct a minimum of 8-10 training and cycling sessions.
15789546|NCT04536766|Behavioral|Enhanced Sleep Health Education|The intervention comprehensively addresses poor sleep health behaviors. Personalized sleep health education will be delivered in two telephone sessions by Beds for Kids staff members. Sleep health information will consist of the following evidence-based pediatric sleep health behaviors: ensuring adequate sleep duration, developing a family bedtime routine, keeping a regular sleep schedule, avoiding caffeine, and eliminating electronics in the bedroom and at bedtime. The enhanced sleep health intervention sessions will also include individualized problem-solving and tailoring to meet the family's needs. Personalization will be accomplished via direct questions to families during the education phone call related to their own barriers to achieving healthy sleep habits and goals for optimal sleep.
15789547|NCT04536766|Behavioral|Beds for Kids Standard Program|The Beds for Kids program provides beds, bedding, and written healthy sleep education to families living at or below 100% of the federal poverty line and without an individual child bed to sleep in.
15789548|NCT04536753|Procedure|Induction of labour|Induction of labour using amniotomy, vaginal prostaglandin administration and syntocinon in combination as per protocol.
15789549|NCT04536740|Device|PDT treatment device|All patients will be treated under general anesthesia. After carefully covering the normal skin, hematoporphyrin monomethyl ether (HMME; Shanghai Fudan-Zhangjiang Bio-Pharmaceutical, Shanghai, China) was i.v. transfused at a dose of 5 mg/kg for 20 min at a constant rate. Five to 10 min after the onset of HMME transfusion, continuous irradiation at 532 nm (532-nm light-emitting diode green-light therapeutic apparatus; Wuhan Yage Optic and Electronic Technique, Wuhan, China) was applied with a power density of 80- 95 mW/cm2 for 20-30 min. Concomitant forced air cooling was applied during irradiation for epidermal protection. Post-treatment skin cooling was performed by intermittent application of ice packs over a 3-day period, to minimize pain and potential thermal damage. To prevent the effects of photosensitivity, patients were instructed to avoid exposure to strong light for at least 14 days after treatment.
15789550|NCT04536727|Behavioral|Fit & Strong!|The 8-week intervention will consist of the Fit & Strong! program adapted to address the impact of exercise on enhancing positive affect and reducing negative affect and depressive symptoms. Exercise classes will meet three times per week for 90 minutes per session for eight weeks. Each class is divided into 60 minutes of strength training, flexibility, and cardiovascular exercise and 30 minutes of group education/discussion, which has been adapted to include affect-oriented content
15789551|NCT04536727|Behavioral|Wait list|Participants randomized to the wait list group receive the 8-week Fit & Strong! intervention after the intervention group has competed it and after the wait list group has provided their post-outcomes.
15789552|NCT04536714|Behavioral|Pythagorean Self-Awareness Intervention program|Stress management program of Pythagorean Self-Awareness Intervention (PSAI), which included eight sessions and lasted for eight weeks. On the first week, a personal session took place for measurements and training in the relaxation technique of diaphragmatic breathing. In the second week, patients attended a group session, in which they were adviced to follow specific directions for a healthy lifestyle, such as organized physical activity, adherence to the Mediterranean diet, creating a daily routine. In the third week, participants were introduced to the cognitive restructuring technique of (PSAI).In the following four group sessions, patients were trained on PSAI and the second relaxation technique, progressive muscular relaxation. In the last week, the final measurements were made. All sessions lasted for 120 minutes, except for the final one, which lasted for 60 minutes.
15789553|NCT04536701|Behavioral|Mood Monitoring and Behavioral Recommendation System|The purpose of this project is to develop a monitoring, modeling, and interactive recommendation solution (for caregivers) for in-home dementia patient care that focuses on caregiver-patient relationships. This includes monitoring for mood and stress and analyzing the significance of monitoring those attributes to dementia patient care and subsequent behavior dynamics between the patient and caregiver. In addition, novel and adaptive behavioral suggestions will be provided to family caregivers via text messages on project Smart phones at the right moments aimed to help improve familial interactions related to caregiving, which over time should ameliorate the stressful effects of the patient's illness and reduce strain on caregivers.
15789554|NCT04536688|Drug|RGLS4326|Solution for subcutaneous injection
15789555|NCT04536675|Drug|Vilanterol and Umeclidinium Bromide|Perioperative inhaler therapy with VI/UME (Vilanterol 25mcg/Umeclidinium 62.5mcg) once daily using Ellipta device from at least for 2 weeks preoperatively to at least 16 weeks post operatively.
15789556|NCT04536675|Drug|Placebo|Perioperative inhaler therapy with placebo once daily using Ellipta device from at least for 2 weeks preoperatively to at least 16 weeks post operatively.
15789557|NCT04536662|Drug|Hydrocortisone|The initial dose of hydrocortisone (20mg/tablet) was 15mg/m2/day to the maximum dose of 60mg, which was orally administered in three times, with the dose ratio of 2:1:3, and the administration time was 8:00-15:00-21:00.
15789558|NCT04536662|Drug|Prednisone|The initial dose of prednisone (5mg/tablet) was 3mg/m2/day to the maximum dose of 15mg. The dosage ratio was 1:2 and the administration time was 8:00 and 21:00.
15789559|NCT04536662|Drug|Dexamethasone|The initial dose of dexamethasone (0.75mg/tablet) was 0.3mg/m2/day to the maximum dose of 0.75mg and the administration time was 21:00.
15789560|NCT04536649|Radiation|Radiotherapy|Multimodal brain imaging-guided radiotherapy using different beams
15789561|NCT04536636|Drug|Docohexanoic acid|Patients received 650 mg DHA/3 times/wk/post-HD session
15789562|NCT04536636|Drug|Control-No drug|Patients received usual medical care with no DHA
15789563|NCT04536623|Behavioral|SIESTA-Rehab Protocol|Inpatient floor assigned to SIESTA-Rehab protocol. Nurses trained to follow batched care protocol and use SIESTA-Rehab staff checklist. Patients are screened for sleep-disordered breathing using ApneaLink device and treated accordingly.
15789564|NCT04536610|Behavioral|Providing structured osteoporosis education|The OP education was performed in groups of 4-5 people by a single physician with a single session in the form of verbal expression via slide, with a duration of 20 minutes.
15789565|NCT04536610|Behavioral|Giving informative leaflet|Leaflets containe the same information as the OP education program
15789566|NCT04536597|Other|Quince seed jelly group|Quince seed jelly, prepared by the researcher, was given to the mothers belonging to this group. Briefly, 3 g (2-3 pieces) of quince seeds are placed in 100 mL water and heated to boiling for 10 min. The prepared quince kernel was used for 3 days, immediately after cooling.14,15 On the 1st day postpartum, the researcher provided the mothers with practical training at the hospital, regarding the application of quince seed jelly to the nipple and areola and leaving it to dry. This training was repeated on the 3rd, 7th and 10th days, to ensure that the mothers followed it precisely. The training process was completed in 5-10 min, including questions and answers. Every 3-4 days (days 1, 3, 7 and 10), quince seed jelly prepared by the researcher was given to the mothers to continue applying, according to the procedure. The mothers were asked to apply it after every breastfeeding.
15789567|NCT04536597|Other|Breast milk group|Mothers in this group received practical training, conducted by the researcher on the 1st day postpartum at the hospital, on applying a few drops of their breast milk to the nipples and areola after each breastfeeding and leaving it to dry. This training lasted 5-10 min. Breast milk application of mothers in this group was recorded on the 1st, 3rd, 7th and 10th days, by the researcher.
15789568|NCT04536597|Other|Control group|Any kind of application that the mothers in the control group did for the nipple fissures were recorded on the 1st, 3rd, 7th and 10th days postpartum, by the researcher
15789569|NCT04536584|Other|Personalized Coaching (Arm A)|Patients will receive personalized physical activity coaching with an online digital platform to take online educational workshops and interact with other peers of the cohort with a online private forum. They will also have a connected watch that will measure several physical activity metrics.
15789570|NCT04536584|Other|Standard supportive approach (Arm B)|Patients will receive the standard recommendations during their visits with the oncologist. The exercise recommendations include strength training and aerobic activities.
15789571|NCT04536571|Device|Test Contact lens|Subjects will be randomized to wear test lenses for 30 minutes, and then cross-over to control lenses.
15789572|NCT04536571|Device|Control Contact lens|Subjects will be randomized to wear control lenses for 30 minutes, and then cross-over to test lenses.
15789573|NCT04536558|Drug|olanzapine plus fosaprepitant-based triple regimen|olanzapine 5mg p.o. on day 1-day 5, fosaprepitant 150mg i.v. on day 1 before undergoing chemotherapy. Patients received ondansetron hydrochloride(8mg, i.v. day 1-day 3) and dexamethasone(6mg, oral, day 1-day 5) at the same time, before undergoing chemotherapy.
15789574|NCT04536558|Drug|placebo plus fosaprepitant-based triple regimen|placebo p.o. on day 1-day 5, fosaprepitant 150mg i.v. on day 1 before undergoing chemotherapy. Patients received ondansetron hydrochloride(8mg, i.v. day 1-day 3) and dexamethasone(6mg, oral, day 1-day 5) at the same time, before undergoing chemotherapy.
15789575|NCT04536532|Drug|HEC121120 tablets|"single-Dose Study: Each dose of HEC121120 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.
~multiple-dose study/Patients with chronic hepatitis B:The study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and/or multiple-dose study."
15789576|NCT04536532|Drug|HEC121120 placebo tablets|"single-Dose Study: Each dose of HEC121120 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.
~multiple-dose study/Patients with chronic hepatitis B:The study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and/or multiple-dose study."
15789577|NCT04536532|Drug|entecavir tablets|Patients with chronic hepatitis B：Administered Entecavir orally once daily for consecutive 28 days in fasted state
15789578|NCT04536532|Drug|entecavir placebo tablets|Patients with chronic hepatitis B：Administered Entecavir placebo orally once daily for consecutive 28 days in fasted state
15789579|NCT04536519|Other|osteoarthritis management|"The conventional physical therapy will be consisted of an array of protocols being deployed in parallel. This will consist of
~Patient education regarding deforming forces, strategies of prevention and home exercise program
~Decreasing stiffness by controlled active range of motion and mobilization techniques involving join play.
~Mechanical stresses will be controlled in form of support provided by foot wear modification
~Range of motion will be increased muscle stretches and manual mobilization techniques
~Muscle performance and neuromuscular control will be addressed by gentle exercises of low intensity and repetitive exercises.
~Balance improvement by employing balance training activities as part of treatment
~Physical conditioning low impact or non-impact aerobics This conventional exercise will be given as baseline treatment to both of groups."
15789580|NCT04536506|Other|Bobath Therapy|Bobath group received 45 min of sessions three times weekly for 12 weeks. An individual program was scheduled for each case following pre-assessment. It was targeted to enable normal posture, facilitation of corrective balance and protective responses and development of normal movement patterns
15789581|NCT04536506|Other|Vojta technique|Vojta group received the following three times weekly for 12 weeks: 1. Reflex crawling, 2. First stage of reflex turning, 3. Second stage of reflex turning. Stimuli (pressure and stretch) for 30-60 sec were given by using the main stimulus points and auxiliary stimulus points together.
15789582|NCT04536493|Drug|LET (lidocaine 4%; epinephrine 0.1%; tetracaine 0.5%) gel (1 application)|1 application of LET topical anesthetic gel
15789583|NCT04536493|Drug|LET (lidocaine 4%; epinephrine 0.1%; tetracaine 0.5%) gel (3 applications)|3 applications of LET topical anesthetic gel
15789584|NCT04536480|Behavioral|Time Limited Eating|This intervention arm will involve TLE, in which participants are instructed to only eat from 11 AM to 7 PM. Therefore, to align with the normal developmental eating patterns seen in adolescents, we will implement an afternoon/evening-based TLE approach. Participants will be allowed to consume non-caloric beverages (water, tea, coffee) during the fasting period. No energy restriction will be used, but participants will be given the low added sugar/carbohydrate guidelines described above. All participants will be asked to record their eating windows daily.
15789608|NCT04536272|Drug|LMWH|Administration of LMWH guided by weight and renal function during ECLS.
15789640|NCT04536038|Behavioral|Opt-out|A study coordinator will call the patient unless they opt-out. See arm description for more details.
15789641|NCT04536025|Other|Qualitative focus group interviews|Prosthetists and/or expert working group members will participate in qualitative focus group interviews up to 120 minutes in length.
15789585|NCT04536480|Device|Continuous Glucose Monitor|Participants will wear Dexcom G6 continuous glucose monitors (CGM, Dexcom, San Diego, CA, USA) continuously for 13 weeks (week -1 to week 12). All participants will be blinded to CGM for seven days prior to commencement of the dietary intervention for baseline data collection, and then randomized to either TLE or control. All initial sensor insertions will be performed at the clinic by participants and/or family member, under the supervision of the study team, using the automated sensor applicator. The sensor will be changed every 10 days. Diurnal glucose profiles derived from interstitial fluid readings performed every 5 minutes over back-to-back 10-day cycles for 91 days will be collected using the CGM device.
15789586|NCT04536480|Behavioral|Control|The control arm will involve no mealtime restrictions. Participants will be instructed to consume food over a 12-hour or more eating window. No energy restriction will be used, but participants will be given the low added sugar and carbohydrate guidelines described above. All participants will be asked to record their eating windows daily and submit to the study staff.
15789587|NCT04536467|Drug|Goserelin|chemotherapy+goserelin
15789588|NCT04536467|Drug|Chemotherapy|standard chemotherapy
15789589|NCT04536454|Drug|[18F]FPyGal|Radiotracer for PET-imaging
15789590|NCT04536441|Behavioral|Ultra Brief Online Mindfulness-based Intervention|We adapted and contextualized the original RAIN protocol to local pandemic-induced lockdown situation, with short journaling prompts that engage participants in self-reflection. Journaling is known to be a creative way to engage people in a therapeutic activity which promotes self-awareness (Utley & Garza, 2011). Creating a visual narration of thoughts, feelings and experiences help individuals make internal experiences more tangible and manageable, especially during these uncertain times.
15789591|NCT04536441|Behavioral|Control|The control group participants were asked to report preventive measures that they have taken to prevent COVID-19, ways that they obtained Movement Control Order news, and things that they wished to do once the Movement Control Order is lifted.
15789592|NCT04536428|Device|Endoscopic hemostasis with clip|"This intervention is performed as the following orders.
~The tip of endoscope is accessed to a bleeding site.
~The accurate visualization of bleeding site is done.
~A sheath of delivery system of clip is inserted through a working channel of endoscope.
~The end of clip is opened in front of the bleeding site. If needed, clip could be rotated to adjust to a bleeding target.
~The both ends of clip are placed on both sides of a bleeding site.
~If bleeding is still continued, additional placements of clip are tried until bleeding stops."
15789593|NCT04536415|Drug|Oseltamivir Phosphate 75 mg capsules|Capsules, 75 mg, single, oral dose
15789594|NCT04536415|Drug|Tamiflu capsules 75 mg|Capsules, 75 mg, single, oral dose
15789595|NCT04536389|Procedure|Office Hysteroscopy|"The hysteroscope with its light source and flowing fluid was gently introduced into the vagina allowing for gradual distention. Once this was accomplished, the anatomy was followed with delicate movements. The hysteroscope was advanced under vision to the level of the ectocervix, and guided into the endocervical canal. Once the endocervical canal was completely explored, the endoscope was advanced across the internal cervical os to allow evaluation of the panoramic view of the uterine cavity.
~hysteroscopic correction of any detected lesion will be scheduled to the endoscopic operative list or the patient will receive the appropriate medical treatment."
15789596|NCT04536376|Behavioral|Resilience Program|Subjects receive program devices, and will be asked to wear during rest and sleep on a nightly basis along with active use during daytime. Notifications are sent daily, individualized approach developed and sent to participants to participate on.
15789597|NCT04536363|Drug|Analogs, Prostaglandin E1|"Analog of PGE1:
~Infusion starting dose: 0.05 -0.01 mcg per kilogram of weight per minute in infusion continues, maximum 7 days, until achieving the desired clinical response (increase in PaO2), at that time decrease the infusion rate to the lowest dose possible to keep answer. This can be accomplished by decreasing the dose from 0.1 to 0.05 to 0.025 to 0.01 mcg / kg / min.
~If the response to 0.05 mcg / kg / min is inadequate, the dose can be increased to 0.4 mcg / kg / min, although in general high doses do not produce better effects. Maximum continuous infusion for up to 7 days"
15789598|NCT04536363|Drug|Standard therapeutic protocol|"Standard medical treatment is governed by current recommendations of national scientific societies and the Ministry of Health and Social Protection and may be modified throughout the course of the study according to the available evidence. In addition, the criteria of the treating physician are taken into account.
~Among the alternatives proposed by the current clinical practice guidelines are:
~Dexamethasone (4mg ampoule, intravenous) Dose: 6mg intravenous every day for a maximum of 10 days
~Tocilizumab Dose: 8 mg / kg (maximum dose of 800 mg) IV, maximum 3 doses 8 to 12 hours apart
~Empirical Antibiotic Therapy in patients with suspected pneumonia (according to management guidelines)
~Enoxaparin (40mg prefilled syringe) Dose: 40mg subcutaneously every 24 hours
~Enoxaparin (20mg, 40mg, 60mg, 80mg prefilled syringe) Dose: 1mg / kg every 12 hours
~Low molecular weight heparin (5000IU prefilled syringe) Dose: 5,000 IU subcutaneous every 12 hours"
15789599|NCT04536350|Drug|Aviptadil 67μg|Participants will receive standard care plus a dose of 67μg nebulized Aviptadil three times a day for ten days.
15789600|NCT04536350|Drug|Placebo 0.9% NaCl solution|Patiens will receive Standard care plus 0.9% NaCl solution three times a day for ten days
15789601|NCT04536337|Drug|ALG-000184|Single or multiple doses of ALG-000184
15789602|NCT04536337|Drug|Placebo|Single or multiple doses of Placebo
15789603|NCT04536324|Procedure|Subcutaneous parenteral hydration|Patients will twice receive a subcutaneous infusion of 250 ml isotonic sodium chloride (NaCl) with 30 MBq Tc-99m pertechnetate mixed in. The patients will receive the first infusion during admission to our geriatric ward (when they are acutely ill) and the second infusion approximately 8 weeks after discharge when they are no longer acutely ill. The subcutaneous access will be placed on the abdomen in the lower left or right quadrant.
15789604|NCT04536311|Procedure|internal fixation of mulitiple rib fracture|The dislocated rib fracture was anatomically reduced, and then fixed with appropriate equipment to prevent the fracture from being displaced again
15789605|NCT04536298|Dietary Supplement|vitamin D|Vitamin D softgel capsules; each capsule contains 3200 IU of vitamin D3. Three capsules per day (9600 IU/day) will be taken on days 1 and 2, and one capsule per day (3200 IU/day) will be taken on days 3 through 28
15789606|NCT04536298|Dietary Supplement|Placebo|Placebo softgel capsules. Three capsules per day will be taken on days 1 and 2, and one capsule per day will be taken on days 3 through 28
15789607|NCT04536272|Drug|Heparin|Administration of heparin with a target of 2-2.5 or 1.5-2.0 times baseline aPTT during ECLS.
15789609|NCT04536259|Behavioral|Video Default|"The case and response options participants in this group will be asked to consider is provided below.
~Imagine that a hospital clinician you have been seeing for over a year tells you that that upon reviewing your patient notes they would like you to attend your next consultation by video.
~Consider each of the response options below, and select the one that best describes how you would respond to your clinician.
~A) Yes, I would be happy to attend a video consultation. B) If possible, I would rather attend the appointment in person."
15789610|NCT04536259|Behavioral|In-Person Default|"The case and response options participants in this group will be asked to consider is provided below.
~Imagine that a hospital clinician you have been seeing for over a year tells you that that upon reviewing your patient notes they would like you to attend your next consultation in person.
~Consider each of the response options below, and select the one that best describes how you would respond to your clinician.
~A) Yes, I would be happy to attend an in-person consultation. B) If possible, I would rather attend the appointment by video."
15789611|NCT04536259|Behavioral|Active Choice|"The case and response options participants in this group will be asked to consider is provided below.
~Imagine that a hospital clinician you have been seeing for over a year tells you that that upon reviewing your patient notes they would like you to attend a consultation by video or in person.
~Consider each of the response options below, and select the one that best describes how you would respond to your clinician.
~A) I would prefer a video consultation. B) I would prefer an in-person consultation."
15789612|NCT04536246|Procedure|Bone Quadriceps Tendon (BQT) arthroscopic-assisted ACL reconstruction|New intervention method deployed in Indonesia to gain better clinical outcome for ACL--deficient patients requiring surgical treatment
15789613|NCT04536246|Procedure|Single-Bundle Hamstring Tendon (SBHT) arthroscopic-assisted ACL reconstruction|Comparator for New Reconstruction Technique
15789614|NCT04536233|Biological|MSCs Derived Pleiotropic Factors|The pleiotropic factor derived from mesenchymal stem cells was injected on the wound
15789615|NCT04536233|Other|physiological saline|The physiological saline was injected on the wound
15789616|NCT04536220|Diagnostic Test|Endoscopic Ultrasound (EUS), Fine Needle Aspiration|Endoscopic Ultrasound (EUS), Fine Needle Aspiration, which are routine clinical operations
15789617|NCT04536207|Other|Cryotherapy (apparatus)|Cryotherapy is a pain treatment that uses a method of localized freezing temperatures to deaden an irritated nerve. Cryotherapy is also used as a method of treating localized areas of some cancers (called cryosurgery), such as prostate cancer and to treat abnormal skin cells by dermatologists
15789620|NCT04536181|Drug|Prednisolone|12 weeks prednisolone treatment
15789621|NCT04536181|Drug|Placebo|12 weeks simulated tablets
15789622|NCT04536155|Other|questionnary SF36|"This is a validate questionnary:
~Ware et al,1992, McHorney et al, 1993, McHorney et al, 1994 French version : Author : Alain Leplège; et coll. En 2001"
15789623|NCT04536155|Other|Hospital Anxiety and Depression Scale|this is a validate scale: author: Zigmond A.S., Snaith R.P. in 1983
15789624|NCT04536155|Other|Chronic Pain Acceptance Questionnaire|"This is a validate questionnaire:
~Fish, R., McGuire, B.E., Hogan, M., Stewart, I. & Morrison, T. (2010)."
15789625|NCT04536155|Other|digital pain scale|this is a validate scale A.N.A.E.S. February 1999
15789626|NCT04536142|Diagnostic Test|MRI|A research MRI scan will be performed within 1 week prior to surgery and again 2 weeks after surgery. The surgical removal of the brain tumor(s) is not a component of this research. The MRI scan will perform both programs (diffusion MRI, resting state MRI) during the same single session. The healthy controls will obtain identical research scans with the second session between two and three weeks following the first session, since they will not undergo a surgery.
15789627|NCT04536142|Diagnostic Test|neuropsychological tests and qualitative assessment|"Neuropsych Tests: COWA, Trails, RCFT, RAVLT, WMS-III subtests, NAB Digits, Grooved Pegboard, Stroop Color Word Test, verbal and spatial working memory, WRAT-IV, Word Reading subtest.
~Standardized quality of life measures: MDASI-BT, FACT-Br, FrSBe"
15789628|NCT04536129|Drug|Hydrocortisone (CORTIVIS ®)|Once enrolled all the patients had to instill topical low dose (1,005 mg) preservative-free hydrocortisone (CORTIVIS ®- Medivis, Catania, Italy) 2 times daily in each eye for two weeks.
15789629|NCT04536116|Device|Virtual Reality headset|MRI simulation with a Virtual Reality headset
15789630|NCT04536103|Diagnostic Test|MRI|Observational Study of novel MR imaging and image processing techniques that will provide reliable and fully quantitative evaluation of inflammation, chronic structural changes and vascularity in healthy patients and patients with ACL injury.
15789631|NCT04536090|Drug|Isoquercetin (IQC-950AN)|Isoquercetin will be administered by mouth twice daily for 28 days
15789632|NCT04536077|Drug|CDX-301|The drug will be supplied free of charge by Celldex
15789633|NCT04536077|Drug|CDX-1140|The drug will be supplied free of charge by Celldex
15789634|NCT04536077|Procedure|Research blood draw|At screening; prior to first therapeutic dose of CDX-1140, on the day of the infusion; and at the time of surgery
15789635|NCT04536064|Procedure|LVA and liposuction|"Tumescent technique in lymph-sparing fashion was adopted. Areas were infiltrated with a mix of a standard tumescent solution consisting for each liter of in 1000 ml of saline solution, 50 ml lidocaine 1%, 1 ml epinephrine 1:1000, 10 ml bicarbonate 8,4%. Infiltration volume was approximately from 0,5 to 1 liter for the upper extremities and 1-2 liters for lowers. Three to 4 mm 3 holes blunt cannulas were employed. Aspiration technique was as parallel as possible along the lymphatic network pattern and from superficial to deep layers.
~Lymphatic vessels identified at ICG lymphography were spared. Volume of the aspirate was aimed to approximate 80 percent of the volume difference between the affected and non affected side.
~The number and type of anastomosis were recorded as well as amount of removed lipoaspirate versus the excess limb volume."
15789636|NCT04536051|Biological|ChAdOx1 nCoV-19 single dose + paracetamol|Single dose of ChAdOx1nCOV19 vaccine, 5x10^10 vp + paracetamol
15789637|NCT04536051|Biological|MenACWY single dose + paracetamol|Single dose of MenACWY + paracetamol
15789638|NCT04536051|Biological|ChAdOx1 nCoV-19 two dose + paracetamol|Two dose of ChAdOx1 nCoV-19 vaccine, 5x10^10vp (prime) and 0.5mL boost (3.5 - 6.5 × 10^10 vp), 4-12 weeks apart + paracetamol
15789639|NCT04536051|Biological|MenACWY prime & saline placebo boost + paracetamol|MenACWY prime, and Saline Placebo boost (0.5mL) + paracetamol
15789642|NCT04536025|Other|Qualitative semi-structured interviews|People with lower limb amputation and/or expert working group members will participate in qualitative individual, semi-structured interviews approximately 60 minutes in length.
15789643|NCT04536012|Behavioral|Gamification and Social Incentives|Participants in the intervention arm will receive gamification and social incentives as part of the intervention. See arm descriptions for more detail.
15789644|NCT04535999|Drug|Secukinumab Auto-Injector|300 mg- Every 4 weeks after loading dose (Loading Dose-300 mg once weekly for 5 weeks)
15789645|NCT04535986|Drug|Ensifentrine|"• Dosage Formulation: Ensifentrine Nebulizer suspension
~Dosage 3mg
~Frequency: Twice Daily
~Study to randomize 800 patients in total
~Subjects randomized to the 24-week subset will enroll 400 patients (1:1 ensifentrine (3 mg): placebo)
~Subjects randomized to the 48-week subset will enroll approximately 400 patients randomized 3:1 ensifentrine (3 mg): placebo."
15789646|NCT04535986|Drug|Placebo|"• Dosage Formulation: Ensifentrine Nebulizer suspension
~Dosage 3mg
~Frequency: Twice Daily
~Study to randomize 800 patients in total
~Subjects randomized to the 24-week subset will enroll 400 patients (1:1 ensifentrine (3 mg): placebo)
~Subjects randomized to the 48-week subset will enroll approximately 400 patients randomized 3:1 ensifentrine (3 mg): placebo."
15789647|NCT04535973|Diagnostic Test|unstimulated saliva sample for hormone analysis|hormone levels will be determined in frozen samples of unstimulated saliva
15789648|NCT04535973|Other|quality of life questionnaire|all participants will fill out self-perceived quality of life questionnaire
15789649|NCT04535960|Drug|Empagliflozin 25 MG + Liraglutide 1.8 MG|Patients will be randomized to initial therapy with empagliflozin 25mg PO daily for 6 weeks. After that, patients in the empagliflozin group will also receive liraglutide 1.8mg SC daily for additional 6 weeks.
15789650|NCT04535960|Drug|Liraglutide 1.8 MG + Empagliflozin 25 MG|Patients will be randomized to initial therapy with liraglutide 1.8 mg SC daily, for 6 weeks. After that, patients will also receive empagliflozin 25mg PO daily for 6 weeks.
15789651|NCT04535947|Drug|Vehicle|Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 8 weeks (56 days). Both eyes will be treated.
15789652|NCT04535947|Drug|SDP-4 Ophthalmic Solution (1.0%)|Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 8 weeks (56 days). Both eyes will be treated.
15789653|NCT04535934|Other|Adenine 5+ (five stable-labeled nitrogens)|taggant coencapsulated with an excipient
15789654|NCT04535921|Other|FCR7 questionnaire|A 7 item questionnaire about fear of cancer recurrence
15789655|NCT04535908|Radiation|Hypofractionated radiotherapy|Hypofractionated radiotherapy in prostate cancer patients
15789656|NCT04535895|Radiation|Simultaneous integrated boost|Adjuvant breast cancer irradiation including simultaneous integrated boost
15789657|NCT04535882|Diagnostic Test|serum leucine-rich alpha-2 glycoprotein (LRG) levels|Patients were diagnosed with UC or Crohn disease according to endoscopic, radiological, histological, and clinical criteria. Serum samples were collected from patients, and scores for clinical and endoscopic activity of disease were obtained by reviewing the clinical records of patients. Serum sampling and colonoscopy were performed within 30 days.
15789658|NCT04535869|Drug|Sofosbuvir 400 MG plus Daclatasvir 200mg|This group which receive sofosbuvir and daclatasvir for 14 days plus standard therapy
15789659|NCT04535856|Drug|allogeneic mesenchymal stem cell|"Assignment of Administration Group allogeneic mesenchymal stem cell:
~Low-dose group (5 x 10^7cells)
~High-dose group (1 x 10^8 cells)"
15789660|NCT04535856|Other|Placebo|Control group (placebo)
15789661|NCT04535843|Device|pheripheral biomarkers|Detect the pheripheral biomarkers,including lymphocytes and cytokines, in this prospective MG cohort.
15789662|NCT04535830|Device|Flash Glucose Monitoring System|During the three months experimental period,participants at the FSL group will be asked to wear a flash glucose monitoring sensor for a period of 2 weeks and have a care visit every month while people at SMBG group will receive a care visit every month.
15789663|NCT04535817|Drug|Omalizumab Injection [Xolair]|300mg via 2 subcutaneous injections every 4 weeks
15789664|NCT04535804|Drug|Aspirin/placebo|By using a random, double-blind research method, 1-550 digital computers are randomly divided into two groups, with two groups of digital coding placebo and aspirin. From 12 weeks of gestation, 100 mg of placebo or low-dose aspirin was given orally (2 tablets a time, twice a day, before going to bed) to 36 weeks of gestation.
15789665|NCT04535791|Drug|Cholecalciferol|4,000 IU orally daily for 30 days
15789666|NCT04535778|Behavioral|COMPASS|An 11 module, therapist-supported online CBT program.
15789667|NCT04535778|Behavioral|Standard charity resources|Resources provided by the charities involved, including supportive listening, online support groups, information resources and local community support groups.
15789668|NCT04535765|Other|early warm water sitz bath|The experimental group started the warm water sitz bath 6 hours after the end of the hemorrhoid surgery.
15789669|NCT04535765|Other|Regular time warm water sitz bath|According to the routine, the control group started the warm water sitz bath on the first day after the hemorrhoid surgery.
15789670|NCT04535752|Drug|ANX009|Single or multiple ascending dose
15789671|NCT04535752|Drug|Placebo|Single or multiple ascending dose
15789672|NCT04535739|Radiation|prophylactic cranial irradiation|25Gy/2.5Gy/10f were given for PCI patients
15789673|NCT04535713|Drug|Gemcitabine|600 mg/m2 (Maximum Dose: 1000 mg) i.v. on Day 1 and Day 8 of Cycle 1+
15789674|NCT04535713|Drug|Doxorubicin|18 mg/m2 (Maximum Dose: 32 mg) i.v. on Day 1 and Day 8 of Cycle 1+
15789675|NCT04535713|Drug|Docetaxel|25 mg/m2 (Maximum Dose: 42 mg) i.v. on Day 1 and Day 8 of Cycle 1+
15789676|NCT04535713|Drug|Nivolumab|240 mg i.v. on Day 1 beginnning Cycle 2+
15789677|NCT04535700|Drug|Pioglitazone 30 mg|Patients receive 30 mg/day of pioglitazone for the entire period they remain in hospital
15789678|NCT04535700|Other|standard of care|Patients receive the standard of care, according to the hospital protocol for patients with type 2 diabetes mellitus hospitalized.
15789679|NCT04535687|Drug|Fluzoparib|Fluzoparib
15789680|NCT04535674|Biological|Asunercept|Asunercept (APG101) will be administered once per week as an i.v. infusion
15789681|NCT04535648|Other|Non-invasive detection method: CRISPR techonology|This study was a laboratory diagnostic study without any intervention.
15789779|NCT04534764|Device|1-Day Acuvue DEFINE Vivid Style|CONTROL
15789682|NCT04535635|Other|Active Release Techniques®|The ART® procedure will consist of identifying and treating manipulatable lesions as per their protocols, while the sham group will receive a passable version of this technique. This information is under copyright and cannot be copied or outlined specifically in any form, including a research paper. The overarching procedure used by ART® will be explained however specific details referring to each protocol cannot be described. Muscles are shortened, and the therapist applies sufficient digital pressure to be in contact with the tissue in question. Directional tension is applied proximally along the muscle fiber direction, and then the structure is lengthened while the contact remains as described.
15789683|NCT04535635|Other|Sham Active Release Techniques®|"For the sham treatment, the muscle(s) in question will be taken from a lengthened to a shortened position (opposite of the protocol direction as per the ART® manual) with a broad light contact on the skin - the treating therapist will not achieve tissue depth as specified by ART® and will not attempt to take tension as is outlined in the ART® manual."
15789684|NCT04535622|Behavioral|A structured exercise|Exercise training will be conducted by a physical therapist which will take about 10 to 15 minutes. Patient education will include how to keep face down in various postures, and how to actively exercise the related muscles and joints while maintaining face-down posture through video clip and brochure. Patients will go through three times of self-exercise sessions everyday according to the training provided to the patients. Active exercise for the FDP patients will include exercise in a hands and knees position, limb exercise in an FDP, and exercise in a standing position. The exercises were performed within the range of individual muscle strength and fitness.
15789687|NCT04535596|Other|Exercise|12 week long strength training exercises for knee
15789688|NCT04535570|Other|Indirect Calorimetry|In the pre-transplant, before the conditioning regime, and also on the 10th and 17th post-transplant, the resting energy expenditure was measured by indirect calorimetry.
15789689|NCT04535557|Drug|Mobocertinib 160 mg|Mobocertinib 160 mg, capsule, orally, once daily in 28-day treatment cycles for up to approximately 4 months.
15789695|NCT04535531|Drug|SB206 10.3% berdazimer|Topically once daily
15789696|NCT04535531|Drug|vehicle gel|Topically once daily
15789697|NCT04535518|Drug|IVIG|IVIG at a single dose of 2 g/kg
15789698|NCT04535518|Drug|Aspirin|Aspirin 30 mg/kg in oral per day (given in 3 divided doses), then 3 to 5 mg/kg per day when fever subsides for 72 hours and C-reactive protein (CRP) is normal. Aspirin will be continued for at least 6 weeks after onset of illness.
15789699|NCT04535518|Drug|Infliximab|Intravenous infliximab at single dose of 5 mg/kg, given more than 2 hours.
15789701|NCT04535492|Behavioral|Decision Making Support Tool|Primary care practices randomized in a stepped wedge cluster design will implement a newly developed predictive model and analytic tool to improve shared decision-making for patients.
15789702|NCT04535479|Behavioral|Dry Needling|Dry needling is a procedure in which a thin, stainless steel needle is inserted into the skin to produce a muscle twitch response. It is intended to release a knot in a muscle and relieve pain.
15789705|NCT04535440|Other|No intervention|No intervention
15789706|NCT04535427|Drug|L-arginine|Low (3g every time, 3 times a day)or high dose (5g every time, 3 times a day) of L-arginine will be administered to the experimental groups for at least 24 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.
15789707|NCT04535427|Drug|Placebo|Placebo will be administered to the control group for at least 24 weeks as an add-on treatment to the current DMARDs treatments for rheumatoid arthritis.
15789710|NCT04535401|Drug|Elimusertib|Given PO
15789711|NCT04535401|Drug|Fluorouracil|Given IV
15789712|NCT04535401|Drug|Irinotecan Hydrochloride|Given IV
15789713|NCT04535401|Drug|Leucovorin Calcium|Given IV
15789714|NCT04535388|Device|LK scleral lens|LK scleral lens fitting and application were done for 12 weeks.
15789715|NCT04535375|Diagnostic Test|Doppler Ultrasound of venous cerebral circulation|No additional ultrasound examinations, specifically for the purpose of this study, will be performed. Instead, with each routine ultrasound examination, additional images on top of the routine frames will be collected. Those images will document the velocity and flow in the internal cerebral veins bilaterally using the standard Color Doppler tech-nique. Taking these additional images will prolong the time of ultrasound examination only minimally (with a few minutes).
15789716|NCT04535362|Drug|Nicotine|session will include 3 infusions in the same order: nicotine (1 mg per 70 kg body weight) delivered over 5 minutes, saline and nicotine (1 mg/ 70 kg) delivered over 2.5 minutes.
15790695|NCT04527458|Other|Surge capacity|Capacity of hospitals
15789717|NCT04535349|Diagnostic Test|Whole-body & CZT bone tracer imaging (SPECT)|Quantitative analysis of myocardial uptake of 99mTc-labeled bone radiopharmaceuticals using new whole-body CZT-based SPECT-CT cameras
15789718|NCT04535336|Other|Vitality acupunch (VA) exercise program|The VA had 3 phases and took 40 minutes to complete.
15789719|NCT04535336|Other|Control|Participants maintained their daily activities.
15789720|NCT04535323|Drug|PRP|PRP produced by the subject's own blood will be injected into the vaginal area
15789721|NCT04535310|Device|Precision1® Daily Disposable Contact Lens|Soft, spherical contact lens used to correct distance vision.
15789722|NCT04535297|Other|exposure|Exposure to social distancing due to COVID-19
15789723|NCT04535284|Behavioral|Coaching|"Health Coaching-in-Context that consists of up to 10 sessions, arranged once-a-week or multiple times a week based on convenience of scheduling for up to 10 weeks. The program targets improved caregiver health through occupational therapy coaching."
15789724|NCT04535271|Drug|Trabectedin|This is an open label phase 2 study using metronomic doses of trabectedin, gemcitabine and dacarbazine given intravenously.
15789725|NCT04535258|Device|Blend-A|Treatment for alcohol use disorders will be offered also as an internet-based option.
15789726|NCT04535245|Diagnostic Test|LCI testing|all subjects will have LCI testing then contacted via a phone interview or EMR review yearly times 5 to determine if they have subsequently developed ILD
15789727|NCT04535219|Other|Exercise|60 minutes of moderate-intensity treadmill exercise (70% of maximal heart rate determined from the maximal graded exercise test)
15789728|NCT04535219|Other|Supervised Total Sleep Deprivation|Laboratory-monitored total sleep deprivation
15789729|NCT04535206|Diagnostic Test|Venous blood collecting and test and ultrasound screening|To collect the venous blood samples before the PICC catheterization, and perform ultrasound examination before and after the catheterization at the specified time point in follow-up.
15789730|NCT04535193|Drug|18F-mFBG for intravenous administration|Positron-emitting tomography (PET) (either PET/CT or PET/MR) imaging agent
15789731|NCT04535180|Diagnostic Test|Dual-energy X-ray absorptiometry (DXA)|"Body composition will be measured using whole-body DXA (GE Lunar iDXA, GE Healthcare Lunar, Madison, Wisconsin, U.S.A.). Extremity skeletal muscle mass will be calculated using the values measured via the DXA; ASM will be calculated as the sum of skeletal muscle mass in the arms and legs, assuming that the mass of lean soft tissue is a skeletal muscle. Appendicular skeletal mass index (ASM/Ht2 ) will be determined as the sum of the arm and leg lean mass (kg)/height2 (m2
~). BMD will be measured in lumbar spine and bilateral hip by the same DXA device (GE Lunar iDXA, GE Healthcare Lunar, Madison, Wisconsin, U.S.A.)"
15789732|NCT04535167|Drug|PF-07304814|PF-07304814 is an anti-viral, formulated for intravenous delivery
15789733|NCT04535167|Drug|Placebo|Placebo will be formulated for intravenous delivery
15789734|NCT04535154|Other|No interventions|No interventions
15789735|NCT04535141|Drug|Olanzapine 5 MG|It will be a de-identified pill created by investigational drug services at UNC
15789736|NCT04535141|Drug|Placebo|It will be a de-identified pill created by investigational drug services at UNC
15789737|NCT04535128|Other|No intervention|No intervention
15789738|NCT04535115|Procedure|Starting LRM (Lung Recruitment Maneuver)|The LRM is performed first for 30 seconds (an insufflation pressure of 30 cmH2O for 30 seconds is applied). After a free interval of 3 minutes, the VtC is done during 1 minute. For VtC, tidal volume is increased from 6 to 8 ml.kg-1 of predicted body weight. Finally, after a new free interval of 3 minutes, the fluid challenge (consisting in fluid administration of 250 ml of Ringer Lactate) is started for 10 minutes (in aim to determine which patients are responders). This sequence is repeated every 30 minutes (maximum four times).
15789739|NCT04535115|Procedure|Starting VtC (Tidal Volume Challenge)|The VtC is performed first for 1 minute. After a free interval of 3 minutes, the LRM is done for 30 seconds. Finally, after another free interval of 3 minutes, the fluid challenge is started for 10 minutes. This sequence is repe-tead every 30 minutes (maximum four times).
15789740|NCT04535102|Drug|Polatuzumab Vedotin|Polatuzumab vedotin is an ADC designed for the targeted delivery of MMAE(mono-methyl auristatin E), a potent microtubule inhibitor to lymphoma cells expressing CD79b. MMAE has a mechanism of action that is similar to that of vincristine.
15789741|NCT04535089|Drug|Dexmedetomidine injection|receive IV bolus dose of 0.5 ug/kg dexmedetomidine diluted in 10ml saline 1% over 15 minutes followed by continuous infusion of 0.5 ug/kg/h
15789742|NCT04535089|Drug|Lidocaine Iv|IV bolus dose of 1mg/kg lidocaine 1% over 15 minutes followed by continuous infusion of 1.5mg/kg/h
15789743|NCT04535076|Procedure|Transcatheter Aortic Valve Implantation|Transcatheter Aortic Valve Implantation
15789744|NCT04535076|Procedure|Surgical Aortic Valve Replacement|Surgical Aortic Valve Replacement
15789745|NCT04535063|Biological|COVID19 convalescent plasma infusion|intravenous infusion of 300-600 mL of convalescent plasma with an antibody title more than 3 according to chemiluminescent microparticle immunoassay (Architect Plus Abbott)
15789746|NCT04535050|Device|Renal denervation|Renal Denervation: DENEX system
15789747|NCT04535050|Procedure|Renal angiography|Renal angiography
15789748|NCT04535037|Biological|DTPa-HBV-IPV/Hib|3 doses (1 each at 2, 4 and 12 months of age) of DTPa-HBV-IPV/Hib vaccine administered by intramuscular injection into the right thigh
15789749|NCT04535037|Biological|DTaP5-HBV-IPV-Hib|3 doses (1 each at 2, 4 and 12 months of age) of DTaP5-HBV-IPV-Hib vaccine administered by intramuscular injection into the right thigh
15789750|NCT04535037|Biological|Pneumococcal 13-valent conjugate vaccine|3 doses (1 each at 2, 4 and 12 months of age) of pneumococcal 13-valent conjugate vaccine administered by intramuscular injection into the left thigh
15789751|NCT04535024|Radiation|Stereotactic Ablative Radiotherapy (SABR)|"We plan to irradiate as many metastatic lesions as possible, in the precondition that normal tissues can tolerate.
~Target dose will be adjusted depending on site of the lesion and organs at risk (BED > 100Gy).
~Treatment schedule is once per day and five days per week. Sequence of irradiation for multiple metastases is at the discretion of the investigators based on their experience."
15789752|NCT04535024|Drug|Sintilimab|Starts within one week upon SABR completion: 200mg, d1, q3w; Continued until disease progression, unacceptable toxicity or patient withdrawal.
15789881|NCT04533880|Other|Autologous bone graft|Autologous bone grafting involves utilizing bone obtained from the same individual receiving the graft
15789753|NCT04535011|Behavioral|PPKAY (brief intervention)|PPKAY is a nurse-administered, one-on-one, 15-minute brief intervention (BI) for alcohol use using FRAMES motivational interviewing techniques. The BI is a four-step discussion: 1) Raise the Subject of Alcohol, 2) Provide Feedback, 3) Enhance Motivation 4) Negotiate and Advice.
15789754|NCT04535011|Behavioral|Standard Booster|After discharge from the hospital, a standard motivational text message will be sent to their cell phone twice monthly for the duration of the study. In a rotating fashion, one of four standard motivational texts translated into Swahili will be sent to their cell phones.
15789755|NCT04535011|Behavioral|Personalized Booster|After discharge from the hospital, a personalized motivational text message will be sent to participant cell phones twice monthly for the duration of the study. In a rotating fashion, one of four personalized motivational texts will be sent to their cell phones. Personalized texts will be created with the content obtained from the motivational interview sessions. At each session, the research nurse conducting the intervention will record four messages based on the content of the session to be sent as the Personalized Booster.
15789756|NCT04534998|Procedure|Partial nephrectomy|Partial nephrectomy for localized kidney cancer as curative treatment.
15789757|NCT04534985|Behavioral|Dietary|Dietary intake behavioral intervention via time restricted feeding and normal healthy eating recommendations vs. normal healthy eating recommendations without restricted
15789758|NCT04534972|Other|Targeting Normoxia (SpO2 90-96%; PaO2 60-100 mmHg)|Post-implementation of targeted normoxia through oxygen titration for individual patients. Intervention for treatment of hypoxia will follow usual local practice. Interventions for treatment of hyperoxia (SpO2 >96% or PaO2 > 100 mmHg) will involve down titration of FiO2 (or supplemental oxygen for non-mechanically ventilated patients) within a time frame based on local site preferences-typically in increments of no greater than 0.10 until goal oxygenation in the normoxia range is achieved (including room air [no supplemental oxygen] for non-mechanically ventilated patients).
15789759|NCT04534959|Other|Targeting Normoxia (SpO2 90-96%; PaO2 60-100 mmHg)|Post-implementation of targeted normoxia through oxygen titration for individual patients. Interventions for treatment of hypoxia will follow usual local practice. Interventions for treatment of hyperoxia (SpO2 >96% or PaO2 >100 mmHg) will involve down titration of FiO2 (or supplemental oxygen for non-mechanically ventilated patients) within a time frame based on local site preferences-typically in increments of no greater than 0.10 until goal oxygenation in the normoxia range is achieved (including room air [no supplemental oxygen] for non-mechanically ventilated patients).
15789760|NCT04534946|Other|This is not an intervention study|This is not an intervention study
15789761|NCT04534933|Device|Evone|Airway ventilation device
15789762|NCT04534933|Device|Primus|Airway ventilation device
15789763|NCT04534907|Combination Product|The combination of exposure and response prevention (ERP) and VR|The combination of exposure and response prevention (ERP) and VR aimed to investigate the combination of an immersive virtual reality environment (VRE) alongside therapist delivered CBT to reduce anxiety when the OCD patients were induced by virtual scene.Specially, patients will get the first CBT session in the first week for 90 minutes in order to gather detailed information of individual's symptom. Then the next 2 weeks, patients will get VR+ERP session twice a week. From the fourth week to the seventh week, patients weill get VR+ERP session once a week. In the end of the eighth week, patients will get the last session of the exposure-based CBT for relapse prevention.
15789764|NCT04534907|Behavioral|Traditional ERP|Patients will achieve the exposure based CBT for total 10 times excluding 8 sessions of ERP. Structured protocol described by Foa et al., 2012. Specially, patients will get the first CBT session in the first week for 90 minutes in order to gather detailed information of individual's symptom. Then the next 2 weeks, patients will get ERP session twice a week. From the fourth week to the seventh week, patients weill get ERP session once a week. In the end of the eighth week, patients will get the last session of the exposure-based CBT for relapse prevention.
15789765|NCT04534894|Diagnostic Test|fluorescence lifetime imaging microscopy|collect 2mL of venous blood and use fluorescence lifetime imaging microscopy to exam NADH fluorescence characteristics of it
15789766|NCT04534881|Drug|Progesterone 200 MG|Subjects will be randomized to receive generic micronized progesterone 200 mg or placebo tablets, to be taken at bedtime daily.
15789767|NCT04534881|Drug|Placebo|Subjects will be randomized to receive generic micronized progesterone 200 mg or placebo tablets, to be taken at bedtime daily.
15789768|NCT04534868|Other|taking macroscopic and dermoscopic pictures of suspicious skin lesions|"If there is any diagnostic doubt about a skin lesion, teledermoscopy will be used, if the patient agrees.
~A table containing the useful information about the patient for the lesion's analysis will be completed.
~The pictures will be taken with a Fotofinder Handyscope. The photos will be integrated into the patient's electronic medical record (CareConnect program).
~The photo is anonymized via a serial number assigned by the Handyscope application.
~Sending photos and information via a secure email address to the dermatologists.
~Response from the dermatologist (Prof. Tromme or Dr Harkemanne) in the following days also via email.
~Contact (consultation or telephone call depending on the diagnosis) with the patient to communicate the results and the procedure to be followed.
~This information (emails containing the dermatological report) will be saved in the patient's computerized medical file (CareConnect program) then deleted from the mailbox"
15789769|NCT04534855|Drug|Treprilimab|Treprilimab 240mg Q3W until progression or unacceptable toxicity
15789770|NCT04534842|Drug|SYNB1618|15-day dose-ramp regimen (4 dose levels) of orally administered SYNB1618
15789771|NCT04534829|Procedure|Fluoroscopic-guided Radiofrequency Ablation|Radiofrequency ablation of the posterior SIJ complex under fluoroscopic-guidance
15789772|NCT04534829|Procedure|Ultrasound-guided Radiofrequency Ablation|Radiofrequency ablation of the posterior SIJ complex under ultrasound-guidance
15789773|NCT04534816|Diagnostic Test|Indocyanine Green|Perfusion assessments
15789774|NCT04534803|Drug|BCG Vaccine|.1 mL of reconstituted BCG vaccine given intradermally at baseline.
15789775|NCT04534803|Other|Placebo|.1 nL of diluent (saline) given intradermally at baseline
15789776|NCT04534790|Radiation|Low Dose Radiotherapy|anti-inflammatory effect with low-dose radiation to the lungs
15789777|NCT04534777|Other|repeated neurological, behavioral assessments and conventional, quantitative and functional brain imagery|Based on the collected data, we will evaluate the respective diagnostic accuracy of all the markers acquired in clinical practice regarding the clinical outcome at 2 years.
15789778|NCT04534764|Device|etafilcon A with cosmetic pattern|TEST
15789780|NCT04534751|Biological|Fibrinogen + PCC|"Patients randomized to the intervention group will receive 4g of Fibryga and 2000 IU Octaplex will be released as part of the first and second MHP packs, if requested.
~If a third MHP pack is required, and thereafter, FC will be administered if the fibrinogen level drops below 1.5-2.0 g/L at the discretion of the clinical team or based on conventional laboratory test results or viscoelastic methods.
~Patients in both groups will otherwise receive identical MHP treatment packs (4 units of red blood cells [RBC] in pack 1 and 4 units of RBC and 1 pool of platelets in pack 2 (equivalent to 4 units)."
15789781|NCT04534751|Biological|Frozen Plasma|"4U FP will be released as part of the first and second MHP packs.
~Patients in both groups will otherwise receive identical MHP treatment packs (4 units of red blood cells [RBC] in pack 1 and 4 units of RBC and 1 pool of platelets in pack 2 (equivalent to 4 units).
~Patients randomized to the control group may receive FC if the fibrinogen level drops below 1.5-2.0 g/L at the discretion of the clinical team or based on conventional laboratory test results or viscoelastic methods. FC dosing in MHP packs 3 and above will be site-specific and at the discretion of the treating clinician."
15789782|NCT04534738|Behavioral|Mediterranean Diet|The Mediterranean Diet is high in fruit, vegetables, legumes, nuts and seeds, whole grains, and olive oil; moderate in seafood, dairy products (e.g., cheese and yogurt but not whole milk or butter), eggs, poultry, and red wine with meals; and low consumption of sweet desserts, red meat, and highly processed foods.
15789783|NCT04534725|Drug|Interferon alfa|intranasal spray
15789784|NCT04534725|Drug|Selinexor|oral tablet
15789785|NCT04534725|Drug|Lenzilumab|intravenous infusion
15789786|NCT04534712|Diagnostic Test|LYMPHOCYTE MONOCYTE RATIO|Absolute lymphicyte and absolute monocyte counts are recorded on admission of COVID -19 positive patient and ratio is derived. the patients are followed up for any progression of disease stage.
15789787|NCT04534699|Drug|KBP-5074|KBP-5074 tablet
15789788|NCT04534686|Behavioral|CogXergaming|The participant will play four of the six balance board games Table tilt, Tightrope, Soccer, Balance bubble, Light Run and Basic Step (each game is max 1.5 minutes). Each game will be superimposed with any 3 of the 6 cognitive tasks (word list generation consisting of verbal fluency (VF) and category fluency (CF), digit recall (DR), analogies (AN), mental arithmetic (MA), repeated letter (RL). The cognitive tasks will be randomized making sure that all the cognitive tasks are played with all the games. The cognitive and balance board game scores will be noted on the scoring sheet for each session. A total 10 minutes rest interval between every sub-session will be mandatorily provided.
15789789|NCT04534686|Behavioral|Matter of Balance Training|The program emphasizes practical coping strategies that include group discussions, mutual problem solving, exercises to improve strength, coordination and balance, and, a home safety evaluation.
15789790|NCT04534673|Drug|Lambda 180 mcg S.C|Prefilled injection syringe of 180 microgram Pegylated interferon lambda, administered on day 0 and if needed on day 7
15789791|NCT04534660|Device|SMI-01|SMI-01 is a device consisting of silk particles in a hydrogel carrier.
15789792|NCT04534647|Diagnostic Test|different serum and urine biomarkers|urine exosomes and serum biomarkers
15789793|NCT04534634|Combination Product|IFN-α combined with CAR-T cell therapy|"Adults: 14 daily intramuscular injections 300 million IU of Interferon-α for a 28-day cycle.
~Children: 14 daily intramuscular injections 200mg/m^2 of Interferon-α for a 28-day cycle.
~CAR T cell: (1-2)×10^7/kg, intravenously infusion."
15789794|NCT04534621|Other|Electronic survey|Brazilian chiropractors will be invited by email and social media to answer an electronic survey.
15789795|NCT04534595|Other|COVID-19|To study the experience of students and their families during the COVID-19 pandemic an online questionnaire will be utilized. This COVID-19 questionnaire will be administered at three time points: baseline, 6 months upon completion of the baseline questionnaire, and 12 months upon completion of the baseline questionnaire.
15789796|NCT04534582|Drug|HLX14|healthy volunteers receive HLX14 (60mg) once
15789797|NCT04534582|Drug|EU-Prolia®|healthy volunteers receive EU-Prolia® (60mg) once
15789798|NCT04534569|Other|Experts consensus|Consensus opinion using Delphi Methodology
15789799|NCT04534556|Device|Active Vagus Nerve Stimulation|Stimulation of the vagus nerve that is paired with upper limb rehabilitation. VNS stimulation as described in the current study consists of 0.5 second trains of 0.8 mA; 100 µsec biphasic pulses at 30 Hz. Stimulation trains are delivered only during rehabilitation.
15789800|NCT04534556|Device|Placebo Vagus Nerve Stimulation|During Phase 1 of the study, the placebo group will receive a minimal amount of stimulation that fails to sufficiently activate the nerve, unknown to the participant and therapists. All participants will receive active stimulation during the Phase 2 open-label portion of the study.
15789801|NCT04534543|Radiation|MRI/Spectroscopy|Participants will undergo multiple 7T MR imaging sessions which include advanced 31P MRSI techniques, before start of palliative chemotherapy and during treatment until progression of disease or until week 54.
15789802|NCT04534530|Other|Systematic screening for ischemic heart disease in type 2 diabetic patients|Systematic screening for ischemic heart disease in type 2 diabetic patients at very high cardiovascular risk, without known coronary heart disease.
15789803|NCT04534517|Device|JJV Investigational Multifocal Contact Lens|TEST Lens
15789804|NCT04534517|Device|ACUVUE OASYS® with HYDRACLEAR® PLUS|The spherical test lens was used in the troubleshooting steps only for low ADD subjects who have reported a distance vision complaint.
15789805|NCT04534504|Procedure|SG-JJB|Base on SG-JJB procedure, the jejunum was not transected, only 200-cm jejunum 20-cm distal to Treiz ligament was measured and side-to-side jejunojejunal anastomosis was made. And the jejunum 3-5cm distal to the anastomosis was ligated with 10# suture.
15789806|NCT04534491|Drug|Oxybutynin (Oxytrol, BAY839380)|Oxybutynin transdermal patch, 3.9 mg daily (Oxytrol Transdermal System)
15789807|NCT04534478|Drug|Prednisone|Patients will be randomized 1: 1 between the two arms of the study
15789808|NCT04534465|Drug|Polyethylene glycol (MiraLAX, BAY81-8430)|Oral solution, 17g polyethylene glycol, one time
15789809|NCT04534465|Drug|Mannitol|Oral, 2g, 4g, 6g, 8g and 10g mannitol, one time
15789810|NCT04534452|Drug|Phenylephrine HCl (Sinus Comfort, BAY112476)|30 mg Extended Release Tablets, single oral dose
15789811|NCT04534439|Drug|APX-115|oral administration of APX-115 400mg capsule once daily for 12 weeks
15789812|NCT04534439|Drug|Placebo|oral administration of APX-115-matching placebo 400mg capsule once daily for 12 weeks
15789813|NCT04534426|Drug|: Arnica montana|In Arnica group, patients were given an unlabelled tube containing cream to be applicated topically on skin surface of masseteric and submandibular region, 2 cm in length cream for each 8 hours, starting immediately after surgery and continued for 10 days
15789814|NCT04534426|Drug|Mucopolysaccharide polysulfate|In Arnica group and MPSP group, patients were given an unlabelled tube containing cream to be applicated topically on skin surface of masseteric and submandibular region, 2 cm in length cream for each 8 hours, starting immediately after surgery and continued for 10 days
15789815|NCT04534426|Other|Control group|In Control group, only standard therapy was performed after surgery
15789816|NCT04534413|Device|composite optical fiberscope (COF)|Fiber Technology
15789817|NCT04534400|Radiation|thoracic CT-scan|Automated measurement
15789818|NCT04534387|Other|Spanish-Language Hearing Loss Toolkit for Self-Management|The materials include printed information and images designed to increase hearing loss knowledge and focus on self-management topics such as the fundamentals of the ear and hearing, communication strategies, speech understanding in noise, and hearing technology.
15789819|NCT04534387|Other|American Speech-Language-Hearing Association (ASHA) Audiology Series Spanish Language Handouts|Standard of care patient education handouts developed by ASHA in the Spanish language.
15789820|NCT04534374|Behavioral|Resistance exercise|Barbell back squat, press, and deadlift for three sets of five repetitions with the weight closest to 75% of their estimated 1 repetition max. The participants were instructed to execute the movement with moderate speed (2s eccentric, 2s concentric, no pause in between). The rest period between sets and exercise movements was two to three minutes.
15789821|NCT04534374|Behavioral|Stretching exercise (sham exercise)|Participants completed a passive stretching exercise session for a similar duration of time as the resistance exercise (≈ 30 min) as sham intervention, which included 15-20 stretching movements twice, holding each for 30 seconds as recommended by ACSM.
15789822|NCT04534361|Other|CBCT measurements|No intervention will be performed on patients for this study. Based on the CBCTs already done previously of the patients in the sample, linear measurements will be taken in order to assess dimensional changes of the alveolar ridge at 1, 3, 5 and 7 mm from the bone crest in the CBCTs taken before and after implant explantation, 4-6 months apart.
15789823|NCT04534348|Device|70% isopropyl alcohol-impregnated catheter caps|Implementation of 70% isopropyl alcohol-impregnated catheter caps in order to assess the number of CLABSI diagnosed during 1 Year
15789824|NCT04534335|Device|SNOO Smart Sleep from Happiest Baby, Inc|Data related to the use of the SNOO itself (collected electronically) such as the amount of movement provided by the SNOO, etc., will be examined with the hemodynamic data obtained during the use of the SNOO. Clinical care data as it relates to the child will also be evaluated as it pertains to the use of the SNOO (this information will focus on the amount and frequency of narcotics administered to the infant). feasibility of use is the device intervention.
15789825|NCT04534322|Drug|Melphalan Flufenamide|Melphalan flufenamide (melflufen) is an investigational peptide-drug conjugate (PDC) that targets aminopeptidases and rapidly releases alkylating agents into tumor cells.
15789826|NCT04534322|Drug|Dexamethasone|Dexamethasone, a synthetic adrenocortical steroid, is a white to practically white, odorless, crystalline powder. It is stable in air. It is practically insoluble in water.
15789827|NCT04534309|Behavioral|Written Weight Loss Material|Participants will receive written weight loss material by email.
15789828|NCT04534309|Behavioral|Weight Loss App|Participants will receive written weight loss material as well as instructions for using a free weight loss app on their phone or computer.
15789829|NCT04534309|Behavioral|Behavioral Lifestyle Weight Loss Intervention (Coaching)|Participants will receive weekly coaching phone calls to encourage regular dietary, exercise, and self-monitoring practices which encourage gradual, healthy weight loss.
15789830|NCT04534296|Other|early mobilization|Early mobilization is a kind of rehabilitation strategy. When the safe standards are met, early mobilization will be performed on subjects randomized in EM group for 30 minutes each time, twice a day, from Monday to Friday. The detailed mobilization activities include bed repositioning，passive or active range of motion and stretching exercises, passive or active respiratory muscle strengthening, sitting in bed, transfer from lying to sitting at edge of bed. Progressive mobilization goals will be individualized for each subject daily, corresponding to their clinical conditions, developmental maturity, strength and endurance.
15789831|NCT04534296|Other|routine care|In this arm, no additional early rehabilitation interventions will be performed except for the routine clinical care, including the ventilation management, spontaneous breathing trials, choice of sedation and analgesia and routine nursing care including repositioning every 2 hours and bed head elevation.
15789832|NCT04534283|Drug|Abemaciclib|Subjects will receive Abemaciclib 150 mg orally twice daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
15789833|NCT04534283|Drug|LY3214996|Subjects will recieve LY3214996 200 mg orally daily until disease progression, unacceptable toxicity, or patient preference to withdraw from study.
15789834|NCT04534270|Drug|Dapagliflozin|Dapagliflozin will be given 5mg per day (weight≤30kg) or 10mg per day (weight>30kg), for 12 weeks
15789835|NCT04534257|Device|SELUTION Sirolimus DCB|Suitable lesions will be treated with SELUTION Sirolimus DCB
15789836|NCT04534244|Device|VBox Hybrid|Medical device intended to treat permanent venous insufficiency of saphenous veins and tributary veins in patients with superficial venous reflux
15789837|NCT04534231|Drug|Nicotine patch|Nicotine transdermal patches as per product monograph
15789838|NCT04534218|Drug|Regorafenib|"For the first cycle: regorafenib will be administered according to the REDOS schedule (80 mg daily for week 1, 120 mg daily for week 2 and 160 mg daily for the third week of the first cycle).
~For the following cycles: regorafenib will be administered at a 80, 120 or 160 mg daily dose according to toxicity observed with the last dose used in the first cycle."
15789839|NCT04534218|Drug|Cyclophosphamide|50 mg per os, daily, for 6 months
15789840|NCT04534218|Drug|Capecitabine|625mg/m²/orally twice daily continuously for 6 months
15789841|NCT04534218|Drug|Aspirin|75 mg orally and daily until progression
15789842|NCT04534205|Biological|BNT113|IV injection
15789843|NCT04534205|Biological|Pembrolizumab|IV infusion
15789844|NCT04534192|Device|JADE Balloon|Suitable TASC C and D lesions will be treated with non-compliant high pressure JADE balloon.
15789845|NCT04534179|Procedure|Vacuum myofascial therapy and physical activity program.|"This group will treated five times with the analgesic program of physium therapy. Each maneuver was performed once per session by slow and progressive. The whole procedure lasted no more than 30 minutes.
~Then they carried out the physical activity program"
15789846|NCT04534179|Other|Physical activity program.|Active Comparator: Physical activity The exercise protocol would last 5 weeks, performing 3 exercise sessions per week, with an effective work time of 20 minutes per session. The exercises would be directly focused on activating the core stabilizing muscles.
15789847|NCT04534166|Other|Risk Prediction of Fracture in Diabetic Patients with Osteoporosis|Risk Prediction of Fracture in Diabetic Patients with Osteoporosis
15789848|NCT04534153|Drug|Fexofenadine Hydrochloride without sodium lauryl sulfate|without sodium lauryl sulfate
15789849|NCT04534153|Drug|Fexofenadine Hydrochloride with sodium lauryl sulfate|with sodium lauryl sulfate
15789850|NCT04534140|Dietary Supplement|HBKB Capsule|The botanical dietary supplement 'Halo Beauty Kiwi Booster' (HBKB) taken daily orally.
15789851|NCT04534140|Other|HBKB Supplement Vehicle|Control group participants will take one capsule of the HBKB botanical dietary supplement vehicle orally, once daily
15789852|NCT04534127|Device|Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)|An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.
15789855|NCT04534101|Behavioral|Virtual Reality Mindfulness|This study is designed to test the feasibility, acceptability and effectiveness of VR mindfulness in patients as they undergo various medical therapies to treat their acute or chronic conditions.
15789856|NCT04534088|Behavioral|Standard Behavioral Weight Loss plus Non-Weight-Related VR app|Standard Behavioral Weight Loss Program
15789857|NCT04534088|Behavioral|Standard Behavioral Weight Loss plus Weight-Related VR app|Standard Behavioral Weight Loss plus Weight-Related VR app
15789858|NCT04534075|Biological|Capsules containing either dietary fiber or placebo|The participants are invited to eat 15 capsules per day. The capsules either contain dietary fiber from psyllium husk or placebo.
15789859|NCT04534062|Other|PNF D2 technique|PNF D2 technique of bilateral upper limb will be performed
15789860|NCT04534049|Other|Intensive Strength Training (IST)|
15789861|NCT04534049|Other|Strength Endurance Training (SET)|
15789862|NCT04534049|Other|Flexibility Training (FT)|
15789863|NCT04534036|Dietary Supplement|PDS-08|PDS-08 is a novel synbiotic comprised of nine probiotic bacterial strains and FOS-inulin as a prebiotic.
15789864|NCT04534036|Other|Placebo|Placebo sachets will contain potato or tapioca maltodextrin.
15789865|NCT04534023|Drug|Idebenone|trial group
15789866|NCT04534023|Drug|Placebo|control group
15789867|NCT04534010|Device|NACgraft|Patients requiring reconstruction of their nipple and areola have a NACgraft surgically implanted on their breasts. A NACgraft is a novel decellularized cadaveric implant derived from human nipples.
15789868|NCT04533997|Drug|Hypertonic saline solution plus intravenous furosemide|"Intravenous 60-minutes of hypertonic saline therapy plus furosemide:
~Furosemide:
~125 mg if home oral furosemide < 160 mg, 250 mg if home oral furosemide ≥ 160 mg
~Hypertonic saline solution:
~Na+ 125-134: 3.6%, Na+ 135-145: 2.4%"
15789869|NCT04533997|Drug|Intravenous furosemide|"Intravenous 60-minutes infusion of furosemide:
~125 mg if home oral furosemide < 160 mg, 250 mg if home oral furosemide ≥ 160 mg"
15789870|NCT04533984|Drug|Forteo Injectable Product|Forteo Injectable Product
15789871|NCT04533984|Other|Placebo|Self-injection of sterile saline
15789872|NCT04533971|Other|Whole body cryotherapy|The WBC procedure consisted of 2-3 min walk in the cryogenic chamber at -110℃. Immediately before the WBC procedures, the patients were provided with a special treatment suit, they were instructed as to how to protect the parts of the body that are particularly vulnerable to frostbite, on the proper way of moving and breathing during the treatment. Excluding Saturdays and Sundays, the WBC treatments were performed daily for the next four weeks. Each time after the WBC the subjects participated in 15-minute kinesitherapy exercises conducted in groups of 5-6 people. The exercises were of general improvement nature and took into account the mobility of the subjects.
15789873|NCT04533958|Device|HYPNO VR® device|"The HYPNO VR® device is a software application of medical hypnosis in the treatment of pain and anxiety. It is associated with equipment: a virtual reality headset and a headphone.
~Before each Docetaxel infusion, the nursing staff offers patients the choices: visual universe, musical theme, male or female voice. The nursing staff selects the chemotherapy program, selects a duration of 20 minutes and presses start to start the medical hypnosis session in virtual reality.
~After completing the hypnotic trance sequence, as in a classic session, the patient is brought back to the return and exit hypnosis phase under the supervision of the nursing staff."
15789874|NCT04533945|Device|FreeStyle Libre|The Freestyle Libre is a device worn on the back of the arm to measure glucose levels in the interstitial fluid. The device is applied by the patient and can be worn for 14 days, at which time it is replaced with a new device. The device does not require calibration with blood glucose testing. A scan with the receiver or a cell phone can be used to obtain glucose levels. The device does not alarm, so scanning is the only way for a patient to know if they are hypo or hyperglycemic. Studies have shown that the use of this technology can improve glycemic control as measured by Hemoglobin A1c and glucose variability in some patients. In addition, use of this technology in the outpatient setting has been associated with both improved patient satisfaction and increased glucose monitoring
15789875|NCT04533932|Diagnostic Test|Elastography|Endosonographic shear wave elastography
15789876|NCT04533919|Procedure|Biospecimen Collection|Undergo collection of dorsal root ganglia
15789877|NCT04533906|Device|Coldamaris lozenges|sucking carageenan containing lozenge
15789878|NCT04533893|Other|Medical simulator (3B Scientific Lilly Pro) and Platform combining simulator sensor data with OSCE scores|Hands-on training app combining OSCE scoring criteria with sensor data retrieved from the simulator's sensors was used for hands-on performance evaluation.
15789879|NCT04533880|Device|DBM|Demineralized bone matrix (Allosync, CDMB Putty, Arthrex, Naples, FL)
15789880|NCT04533880|Device|Calcium phosphate cement|Quickset, Arthrex, Naples, FL
15789882|NCT04533867|Procedure|Laparoscopic sleeve gastrectomy|Sleeve gastrectomy, also called a vertical sleeve gastrectomy, is a surgical weight-loss procedure. This procedure is typically performed laparoscopically, which involves inserting small instruments through multiple small incisions in the upper abdomen. During sleeve gastrectomy, about 80 percent of the stomach is removed, leaving a tube-shaped stomach about the size and shape
15789883|NCT04533867|Drug|Palonosetron 1mcg/kg|Injectable Palonosetron 1 mcg/kg diluted up to 5 mL with normal saline solution and injected intravenously at the end of the bariatric surgery.
15789884|NCT04533867|Drug|Ondansetron 1 mg/kg, max dose 8 mg|Injectable ondansetron 0.1 mg/kg, maximum of 8 mg was injected intravenously at the end of the bariatric surgery.
15789885|NCT04533841|Drug|Misoprostol|Pt will receive misoprostol for labor induction then after 30 minutes will receive ether propranolol or misoprostol
15789886|NCT04533841|Drug|Placebo|placebo
15789887|NCT04533841|Drug|Propranolol|Propranolol
15789888|NCT04533828|Drug|68Ga-FAPI-04|Each subject receive a single intravenous injection of 68Ga-FAPI-04, and undergo PET/CT scanning within the specified time.
15789889|NCT04533815|Behavioral|LOCK sleep intervention|Nursing home staff are trained to use a collaborative problem-solving approach to sleep quality improvement using front-line huddling
15789890|NCT04533789|Other|selected physical therapy program|strengthening muscles of upper and lower limbs, balancing exercise, gait training in open environment, stretching for elbow flexors and forearm pronators,lower limb hip flexors and knee extensor and ankle dorsiflexors
15789891|NCT04533776|Behavioral|Celiac Disease Definition, Symptoms and Treatment|"Adolescents share their knowledge about the disease
~Emphasizing the definition and symptoms of celiac disease
~Discussion of the treatment of celıac disease Expression Question-Answer Discussion Summarizing"
15789892|NCT04533776|Behavioral|Difficulties Due to Celiac Disease|"Determining what experience living with celiac is fot the patient (What do I think about the disease, how do I feel about the disease,how do I perceive the disease, how does the disease affect me)
~Determining the difficulties encountered in Daily life due to illness (How do I deal with difficulties)
~Determining how the disease affects life Expression Question-Answer Discussion Summarizing"
15789893|NCT04533776|Behavioral|Gluten Free Diet in Celiac Disease|"Evaluating dietary information
~Identifying the difficulties in diet therapy Expression Question-Answer Discussion Summarizing Case Study Presentation (Transfer of life experience of an individual who is 22 years old with celiac disease)"
15789894|NCT04533776|Behavioral|Difficulties Related to Disease in School and Social Life|"Assessment of difficulties encountered in school and social life
~Evaluation of the solution suggestions fort he difficulties encountered Expression Question-Answer Discussion Summarizing Örnek Olay Sunumu (Transfer of life of experience of a 23 years old dietician with celiac disease)"
15789895|NCT04533776|Behavioral|Celiac Disease and Its Effects on Acamdemic Success Peer Relations|"Evaluation of the effects of the disease on academic success
~Evaluation of the effects of the disease on peer relationships in the school enviroment
~Difficulties experienced in peer relations and evaluation of relationships (exclusion) Expression Question-Answer Discussion Summarizing"
15789896|NCT04533776|Behavioral|Celiac Diseae anf Future Goals|"General summary of all sessions so far
~Summarizing the topics discussed in the previous session
~Evaluating the future goals of the participants Expression Question-Answer Discussion Summarizing"
15789897|NCT04533776|Other|No Intervention: routine health care- control group|Peer interactive group support was not provided to the control group. After all the sessions of the peer interactive group support of the study were completed, a separate training meeting was held for the control group.
15789898|NCT04533763|Behavioral|Technology-based Mindful Living program|The program is delivered using web-based group conferencing. During each session, participants are taught new stress management and coping techniques. Each week there is opportunity to apply techniques to real world situations for practice. Participants have a group orientation session, and then meet for 10 weeks. Group sessions last 1.5 - 2 hours. Booster sessions occur approximately 4.5 and 9 months post- randomization. Program includes training in mindfulness, cognitive behavioral stress management, relaxation, imagery, prioritizing meaningful activities, communication, and coping strategies. Content is geared toward concerns of cancer survivors.
15789899|NCT04533763|Behavioral|Technology-based Healthy Lifestyles program|The program is delivered using web-based group conferencing. Sessions include content from the National Cancer Institute, American Cancer Society, and health care providers with expertise in oncology. All content is geared to promoting healthy living among ovarian cancer survivors. Participants have a group orientation session, and then meet for 10 weeks, with group sessions lasting 1.5 - 2 hours. Booster sessions occur approximately 4.5 and 9 months post-randomization. Healthy Lifestyle sessions include topics such as nutrition, exercise, sleep, quality of life, survivorship, and cognitive function with content geared toward concerns of cancer survivors.
15789900|NCT04533750|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
15789901|NCT04533750|Drug|Peposertib|Given PO
15789902|NCT04533737|Biological|Brodalumab|Pre-filled syringe with 210 mg brodalumab in 1.5 ml solution for subcutaneous injection
15789903|NCT04533737|Other|Placebo|The placebo solution is similar to the active brodalumab solution except that it does not contain any active substance
15789904|NCT04533737|Biological|Guselkumab|Pre-filled syringe with 100 mg guselkumab in 1 ml solution for subcutaneous injection
15789905|NCT04533724|Drug|Amisulpride|The amisulpride treatment group was given amisulpride tablets. The dose: the initial dose was 50 mg/d. The doctor titrated the dose to the therapeutic amount within 1 to 2 weeks according to the patient's condition. The maximum dose was 300 mg/d, taken with a single meal. Observe for 8 weeks.
15789936|NCT04533490|Drug|SHR-1210|After the subjects were enrolled in the study, the patients were treated with SHR-1210 200mg igvtt q3w from 1 to 2 months after operation until disease progression or intolerable toxicity, and the longest medication period was no more than 12 months
15789964|NCT04533282|Diagnostic Test|Collection of right atrial appendage tissue sample.|Collection of the clinically insignificant small piece of heart's right atrial appendage tissue during either standard cannulation of the right atrium for the installation of the heart-lung machine in the beginning of the operation or additionally for routine surgical protocol.
15789999|NCT04532931|Drug|Pyronaridine-artesunate|SOC plus pyronaridine-artesunate (PA) Weight 45 to <65 kg: 3 tablets (540/180 mg pyronaridine/artesunate) daily for 3 days Weight ≥65 kg: 4 tablets (720/240 mg pyronaridine/artesunate) daily for 3 days
15789906|NCT04533711|Behavioral|OA-PCP Intervention|The OA-PCP intervention includes brief physical activity (PA) counseling delivered via phone by a PA Coach trained in relevant aspects of PA and motivational interviewing. During the initial call, the PA Coach will ask participants about their current physical activity level and work with them to set physical activity goals. Then, after the first call, participants in this group will receive a call about two weeks later, then at about 3 months, 6 months, 9 months and 12 months later. During these calls, the PA coach will ask participants' about their progress toward PA goals and work with them to address any barriers or challenges. The coach will also help participants to identify any programs or resources that may help them to achieve their PA goals. Participants in this group will be asked to wear a wrist-worn monitor to help them track their PA during the intervention period. Also, if participants approve, the coach will use an online program to view their PA data.
15789907|NCT04533711|Behavioral|Attention Control|"This group will receive an intervention in the same dose (e.g., number and duration of phone calls and emails) as the OA-PCP group, but the content will not be PA-specific. During the first call, the Coach will discuss 2 topics, for which the amount of content parallels call #1 for the OA-PCP: What is OA? OA Diagnosis and OA Risk Factors. During the second call, the Coach will discuss the topic of Health Care Providers and Overview of OA Treatment Guidelines. Call topics for 3, 6, 9 and 12- month follow-up calls will be: Pain Medications, Mechanical Treatments (e.g., knee braces, footwear, joint protection), Complimentary and Alternative Therapies and discussion of OA and Mental Health, Sleep and Fatigue."
15789908|NCT04533698|Other|Assessment of reason for resternotomy|No intervention is performed. Reasons for resternotomy (coagulation, fluid balance and other) are retrospectively assessed.
15789909|NCT04533698|Other|Assessment of reason for avoidance of resternotomy|No intervention is performed. Reasons for avoidance resternotomy (coagulation, fluid balance and other) are retrospectively assessed.
15789910|NCT04533685|Behavioral|Portal Reminders for Influenza Vaccination: Direct scheduling link|Patients receive reminder/recall messages via the patient portal to get an influenza vaccination that include a direct scheduling link, enabling the patient to directly schedule a flu vaccination only visit
15789911|NCT04533685|Behavioral|Portal Reminders for Influenza Vaccination: No direct scheduling link|Patients receive reminder/recall messages via the patient portal to get an influenza vaccination (no direct scheduling link included)
15789912|NCT04533685|Behavioral|Pre-Commitment Prompt|Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination
15789913|NCT04533685|Behavioral|Pre-Appointment flu vaccine reminders|Patients receive modified pre-appointment reminders for upcoming scheduled appointments that include language encouraging patients to ask the provider for the flu vaccine
15789914|NCT04533672|Diagnostic Test|MRI Sequences|New multiparametric MRI techniques
15789915|NCT04533659|Behavioral|ADA-based nutrition education with digital self-monitoring|Diabetes nutrition education developed by the American Diabetes Association with digital self-monitoring for diet and physical activity
15789916|NCT04533659|Behavioral|Personalized Behavioral Nutrition (PBN) intervention group|Personalized behavioral nutrition intervention consisting of digital self-monitoring for diet and physical activity, personalized nutrition change goal and recommendation, and diabetes nutrition education developed by ADA
15789917|NCT04533646|Drug|Insulin|Participants will be asked to dose insulin during the first week using fixed doses. During the second week of the study, participants will dose insulin based on carbohydrate counting. Blood sugar control will be compared between the 2 weeks to determine the outcomes of the study.
15789918|NCT04533646|Device|Continuous glucose monitor (CGM)|Participants will be required to wear a CGM to measure glucose trends
15789919|NCT04533633|Procedure|Retrograde Percutaneous Coronary Intervention of Chronic Total Occlusion|Retrograde CTO-PCI using epicardial collateral connections
15789920|NCT04533620|Radiation|Standardized CIRT|CIRT with a dose of 63 GyE/21 fx
15789921|NCT04533620|Radiation|Individualized CIRT|A predictive model will be used to predict the chance of developing mucosal necrosis after salvage carbon-ion radiotherapy, and individualized dose prescription will be given. A dose of 60 GyE/20 fx, 63 GyE/21 fx and 66 GyE/22 fx will be given to patients with high, moderate and low risk of developing mucosal necrosis, respectively.
15789922|NCT04533607|Behavioral|MAAPS|Modular intervention system integrating evidence-based strategies to address core and associated features of ASD and ongoing coaching.
15789923|NCT04533594|Behavioral|NOVELA|The family caregivers that consent to participate will work with the interventionist to use a web-enabled device (computer, smartphone or tablet) to access and view the telenovela video (one of four episodes, each 3-6 mins) over the course of 4 hospice visits (one episode per visit). All four visits will be in person using telehealth via video-conferencing. The number of visits is based on the number of videos which content is prioritized based on previous work. The interventionist will introduce the purpose and topic of the video, facilitate video viewing and then elicit clarifying questions and reinforce main message.
15789924|NCT04533581|Drug|ME-401|In the first 2 cycles (1 cycle is 28 days), subjects will be administered 60 mg of ME-401 orally once a day on a continuous schedule (CS). After that, subjects will be administered 60 mg of ME-401 orally once a day for the first 7 days, followed by rest for 21 days on an intermittent schedule (IS).
15789925|NCT04533568|Drug|Ibuprofen 400 mg|400mg intravenous ibuprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.
15789926|NCT04533568|Drug|Dexketoprofen|50 mg intravenous dexketoprofen with 10mg intravenous metoclopramide Hcl in 100ml 0.9% NaCl for 30 minutes.
15789927|NCT04533555|Genetic|Broad gene panel for young adult cancers|Genetic testing will occur using a broad gene panel for young adult cancers
15789928|NCT04533555|Genetic|Standard|Those in the standard group who are considered high risk will have genetic testing done using the standard of care panel as selected by their care provider.
15789929|NCT04533542|Other|Measurement|Undergo sensory measurements
15789930|NCT04533542|Other|Questionnaire Administration|Ancillary studies
15789933|NCT04533516|Other|Manual therapy technics|Manual therapy technics
15789934|NCT04533516|Other|Inspiratory Muscle Training|Inspiratory Muscle Training
15789935|NCT04533503|Device|HF-OCT Imaging with the Vis-Rx Micro-Imaging Catheter|Intracoronary HF-OCT imaging of the target lesion(s) during the procedure.
15789937|NCT04533477|Procedure|Reconstructing forked corpus spongiosum (FCS)|During the routine standardized surgery, the FCS should be cut off along both sides of the middle urethral plate before dissecting the glans wings and then dissected along the penile tunica albuginea closely from the near to the far side of the penis until the top of the penis head was reached. The corpus spongiosum on both sides will be reserved for the two wings of the glans. The two wings of the glans should be carefully expanded to at least the 3 o'clock and 9 o'clock positions of the penis. Some cases of small glans should be dissected to the 2 o'clock and 10 o'clock positions to close the two wings of the glans with no tension when performing glansplasty. Additionally, the original FCS on both sides should be combined at the coronal sulcus, thereby covering the surface of the new urethra.
15789938|NCT04533477|Procedure|Routine standardized surgery|When the urethral plate can be preserved after degloving, the investigators chose the surgical method according to the width of the urethral plate. If the width of the urethral plate is ≥6 mm, tubularized incised plate (TIP) urethroplasty will be performed, whereas if the width of the urethral plate is <6 mm, the onlay island flap (ONLAY) technique will be performed. When the urethral plate can not be preserved after degloving, transverse preputial island flap urethroplasty (Duckett) will be performed.
15789939|NCT04533464|Biological|MultiStem|Intravenous Infusion
15789940|NCT04533464|Biological|Placebo|Intravenous Infusion
15789941|NCT04533451|Drug|Pembrolizumab|Given IV
15789942|NCT04533451|Drug|Pemetrexed|Given IV
15789943|NCT04533451|Drug|Carboplatin|Given IV
15789944|NCT04533451|Other|Comprehensive Geriatric Assessment|Ancillary studies
15789945|NCT04533451|Other|Questionnaire Administration|Ancillary studies
15789946|NCT04533451|Other|Quality-of-Life Assessment|Ancillary studies
15789949|NCT04533412|Behavioral|Self-management barrier support|For the intervention, community health workers will assess barriers to good self-management behaviors that lie within 4 domains: 1) social context, 2) physical health and functioning, 3) cognitive factors, and 4) psychological factors. They will work with participants for 6 months to help them work through their barriers to self-management of COPD. Participants can also participate in home-based pulmonary rehabilitation and can receive emergency pack/action pack medication for COPD exacerbations.
15789950|NCT04533412|Behavioral|Basic COPD Education|"The attention control will consist of 4 visits by a COPD educator to the home to review the COPD education booklet. During the first visit, this COPD educator will review the COPD 1-2-3 booklet in its entirety with the patient. During visits 2 and 3, the COPD educator will make a visit to check in with the patient, ask how they are doing with their respiratory symptoms, and review any sections of the COPD 1-2-3 booklet the patient chooses. The COPD educator will recommend visits every 2 months but the patient and COPD educator may choose to modify the interval as needed. If the patient appears to be experiencing worsening respiratory symptoms during any visit, the COPD educator will notify the patient's physician."
15789951|NCT04533399|Biological|SARS-CoV-2 rS/Matrix-M1 Adjuvant|Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS co-formulated with Matrix-M1 adjuvant (0.5 mL) on Days 0 and 21.
15789952|NCT04533399|Other|Placebo|Alternating intramuscular (deltoid) injections of placebo (0.5 mL) on Days 0 and 21.
15789953|NCT04533386|Behavioral|Multi-component intervention strategy|Multi-component intervention strategy using a peer change agent and mobile application to record and review sexual risk behaviors
15789954|NCT04533373|Procedure|DIEP Flap Neurotization|"We will be performing breast reconstruction using tissue from the patient's abdomen and transferring it to the chest wall to repair the mastectomy defect. Sensory function is restored by using the nerve that supplies the skin of this abdominal tissue (i.e the new source) that is being transferred and attaching it to a nerve in the chest wall."
15789955|NCT04533360|Diagnostic Test|VITROS Anti-SARS-CoV-2 IgG test|The VITROS Anti-SARS-CoV-2 IgG test is a lateral flow immunoassay produced by Ortho-Clinical Diagnostics Inc.
15789956|NCT04533347|Drug|Tafenoquine Oral Tablet|Patients will be randomized and will receive and self-administer 200 mg Tafenoquine or matching placebo on Days 1, 2, 3, and 10.
15789957|NCT04533347|Drug|Placebo|Patients will be randomized and will receive and self-administer 200 mg Tafenoquine or matching placebo on Days 1, 2, 3, and 10.
15789958|NCT04533334|Procedure|FOB measurement|A FOB will be inserted after anesthesia induction and the distances will be measured by direct observation via the bronchoscope.
15789959|NCT04533321|Drug|Afatinib|Afatinib is approved therapy for SCC of the lung after progression with standard of care chemotherapy.
15789960|NCT04533308|Behavioral|Relaxation in virtual reality|Natural 360-degrees scenes from different locations in the world with or without interactions with animals in the virtual reality
15789961|NCT04533295|Device|acupuncture and IVF|Acupuncture was performed three times a week for 30 minutes each time, starting from the 5th day of menstruation and ending within 24 hours after embryo transfer.
15789962|NCT04533295|Device|sham acupuncture and IVF|Sham acupuncture was performed three times a week for 30 minutes each time, starting from the 5th day of menstruation and ending within 24 hours after embryo transfer.
15789963|NCT04533282|Diagnostic Test|Blood samples.|Peripheral blood samples (TEMPUS(TM) whole blood samples, EDTA plasma and heparin plasma, total volume 40ml) taken during (1) initial hospitalisation and (2) three month follow-up visit after hospital stay (follow-up samples are not taken from coronary CT healthy control patients).
15789997|NCT04532931|Other|Standard of care (Paracetamol)|SOC - 2 tablets (1000 mg) to be taken 6-hourly as needed
15789998|NCT04532931|Drug|Artesunate-amodiaquine|SOC plus artesunate-amodiaquine (ASAQ) - 2 tablets (200/540 mg artesunate/amodiaquine) daily for 3 days
15789965|NCT04533282|Diagnostic Test|Health Survey, Clinical symptom scaling|Patients in the study CABG and AVR cohorts are invited to both pre- and postoperative (3-month time-point), and in the case of PCI cohort only to postoperative, appointments led by experienced clinical cardiologists. The appointments will include clinical anamnesis, status and assessment of morbidity level with combined use of Canadian Cardiovascular Society grading of Angina Pectoris (CCS), New York Heart Association Classification for Heart Failure (NYHA) classification systems and Short Form 36 (SF36) Health Survey. The CT imaging control cohort is not invited to these appointments.
15789966|NCT04533282|Diagnostic Test|Transthoracic echocardiography (TTE)|In order to acquire comprehensive insight into the patients' functional heart status, all appointments are supplemented with echocardiographic evaluation for both functional as well as structural parameters. Detailed echocardiographic analysis criteria for the IHD-EPITRAN study are prespecified in the research plan.
15789967|NCT04533269|Other|Arnica montana, Ledum palustre|Homeopathic
15789968|NCT04533256|Procedure|CytoSorb|three consecutive sessions of hemoadsorption in patients with sepsis
15789969|NCT04533243|Drug|2.5ug/h transdermal fentanyl|2.5ug/h transdermal fentanyl administers for opioid-naive patients with moderate cancer pain very 3 days
15789970|NCT04533243|Drug|Oral immediate-released morphine|5mg immediate-released morphine every 4 hours, double dose before sleep.
15789971|NCT04533230|Behavioral|Educational intervention with prescription feedback|Educational intervention and targeted feedback on prescription of benzodiazepines and benzodiazepine-like hypnotics
15789972|NCT04533230|Behavioral|Information on treatment guidelines|Written information on treatment guidelines.
15789973|NCT04533217|Procedure|Vertebroplasty|Injection of cement into vertebral lesion(s)
15789974|NCT04533204|Behavioral|mnemonic strategy training|training using mnemonic strategies
15789975|NCT04533204|Behavioral|spaced retrieval training|training using spaced retrieval
15789976|NCT04533191|Procedure|Bilateral implantation of light adjustable intraocular lens and subsequent adjustment to binocular custom vision|Subjects will receive bilateral implantation of a commercially available Light Adjustable Intraocular lens at the time of cataract surgery. Subsequently, they will undergo light adjustment of the lens to target binocular custom vision.
15789977|NCT04533178|Device|soft spinal brace|Use of a soft spinal brace 16 hours per day during the 6 week treatment period.
15789978|NCT04533178|Other|Resting from all sports activities|Resting from all sports activities
15789979|NCT04533165|Behavioral|Exercise|12 week exercise prescription targeting 3 days of at least 30 min of aerobic exercise and 2 days of resistance exercise per week. Adapted to individual abilities, goals, and needs. Exercise intensity targets a 6-7 out of 10 on a 0-10 rate of perceived exertion scale.
15789980|NCT04533139|Drug|Influenza vaccine|"influenza vaccine 0.5 ml intramuscularly each season
~2004-2005 season antigens: A/New Caledonia/20/99(H1N1)-like, A/Wyoming/3/2003(H3N2), and B/Shanghai/361/2002-like antigens
~2005-2006 season antigens: A/New Caledonia/ 20/00(H1N1)-like, A/California/7/2004 (H3N2)-like, and B/Shanghai/361/2002-like antigens"
15789981|NCT04533113|Procedure|Carious tissue selective removal|Carious tissue selective removal in deep carious lesions in posterior teeth, using one of three materials as a liner under the final composite restoration
15789982|NCT04533087|Other|No intervention|No intervention
15789983|NCT04533074|Biological|Single-visit regeneration protocol|In a single visit, access opening, minimal instrumentation and irrigation will be done. After irrigation and drying, the apical tissue will be irritated to evoke bleeding in the canal, using a precurved K-file 2mm past the apical foramen, with the goal of having the entire canal filled with blood to the level of the cemento-enamel junction. The bleeding will be stopped at a level that allows for 3-4 mm of restorative material. Three millimeters of Biodentine will then be placed directly over the blood clot of each tooth. A 3-4 mm layer of glass ionomer is flowed gently over the capping material. Each access cavity will be restored using composite resin.
15789984|NCT04533074|Biological|Multiple-visits regeneration protocol|In the first visit, access opening, minimal instrumentation and irrigation will be done. The root canal will be then dried and filled with calcium hydroxide paste. The tooth will be sealed with an intermediate restorative material (IRM), and the patient will be dismissed for 1-4weeks. In the second appointment, response to initial treatment will be assessed and the steps will be repeated if symptoms are persistent. If there are no symptoms, evoking bleeding to the level of the cemento-enamel junction will be done followed by Biodentine application over the blood clot with final glass ionomer and composite restorations.
15789985|NCT04533061|Drug|Influenza vaccine|"influenza vaccine 0.5 ml intramuscularly each season
~2004-2005 season contains: A/New Caledonia/20/99 (H1N1)-like, A/Fujian/411/2002 (H3N2-like), and B/Shanghai/361/2002-like antigens
~2005-2006 season contains: A/New Caledonia/20/99 (H1N1)-like, A/California/7/2004 (H3N2), and B/Shanghai/361/2002-like antigens"
15789986|NCT04533048|Combination Product|MW33 injection|a recombinant fully human antibody to coronavirus
15789987|NCT04533048|Combination Product|MW33 injection placebo|Placebo
15789988|NCT04533022|Drug|C21|C21 b.i.d.
15789989|NCT04533009|Procedure|spine surgery|Tramadol-paracetamol 325mg/37,5mg two tablets twice daily
15789990|NCT04532996|Behavioral|Trauma-focused psychodynamic psychotherapy|"This psychotherapy addresses disruptions in narrative coherence and affective dysregulation by exploring the psychological meanings of symptoms and their relation to traumatic events. The therapist works to identify intrapsychic conflicts, intense negative affects, and defense mechanisms related to the PTSD syndrome using a psychodynamic formulation that provides a framework for intervention. The transference provides a forum for patients to address feelings of mistrust, difficulties with authority, fears of abuse, angry and guilty feelings, and fantasies.
~This treatment will be provided in-person or over teletherapy as the public health situation demands."
15789991|NCT04532983|Procedure|fixation of mesh prosthesis|in the first group mesh was fixed in position with laparoscopic tacks
15789992|NCT04532983|Procedure|mesh placement without fixation|mesh placement in preperitoneal space without fixation
15789993|NCT04532970|Behavioral|Cessation Counseling|Two different types of smoking cessation counseling
15789994|NCT04532957|Drug|KBP-7072|QD oral capsules
15789995|NCT04532957|Drug|Placebo|matching placebo capsules
15789996|NCT04532944|Diagnostic Test|imaging of energy dysfunction|7T sodium imaging, phosphorus spectroscopy and 3T diffusion-weighted spectroscopy
15790000|NCT04532931|Drug|Favipiravir plus Nitazoxanide|SOC plus favipiravir plus nitazoxanide (FPV-NTZ) Favipiravir: 1600 mg 12-hourly for 1 day then 600 mg 12-hourly for 6 days Nitazoxanide: 2 tablets (1000 mg) 12-hourly for 7 days
15790001|NCT04532931|Drug|Sofosbuvir/daclatasvir|"SOC plus sofosbuvir/daclatasvir (SOF/DCV)
~1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days"
15790002|NCT04532918|Drug|Verinurad|The subjects will receive single oral dose of extended release capsule verinurad 7.5 mg on Day 1 of each treatment period under fasted condition.
15790003|NCT04532918|Drug|Allopurinol|The subjects will receive single oral dose of tablet allopurinol 300 mg on Day 1 of each treatment period under fasted condition.
15790004|NCT04532918|Drug|Cyclosporine|The subjects will receive single oral dose of soft capsule cyclosporine 600 mg on Day 1 of treatment period 2 under fasted condition.
15790005|NCT04532918|Drug|Rifampicin|The subjects will receive single oral dose of film coated tablets rifampicin 600 mg on Day 1 of treatment period 3 under fasted condition.
15790006|NCT04532905|Other|Strength Training Exercises Therapy|Five type of exercises: dumbbell bent row over, deadlift, lunge, shoulder press, and squat with each three sets and 10 repetitions. Between each set there will be 2-3 minute rest period and 8-10 minute rest period among each exercise type.
15790007|NCT04532892|Dietary Supplement|Meta 18.06 Day and Meta 18.06 Night|5 visits after screening (V0-V4), including questionnaires (V0-V2-V4), salivary tests (V0 & V4) and calls for antistress advices and adverse events, concomitant medication reporting & compliance (V1 & V3)
15790008|NCT04532892|Dietary Supplement|Placebo Meta 18.06 Day and Placebo Meta 18.06 Night|5 visits after screening (V0-V4), including questionnaires (V0-V2-V4), salivary tests (V0 & V4) and calls for antistress advices and adverse events, concomitant medication reporting & compliance (V1 & V3)
15790009|NCT04532879|Device|HygiPrep (HyGIeaCare System)|Controlled gravity-based high-volume colon irrigation
15790010|NCT04532866|Behavioral|Isolation and Confinement|Eight months of isolation and confinement in the spaceflight analog NEK in Moscow
15790011|NCT04532840|Device|cryotherapy (Gymna Cryoflow ICE-CT)|Cryotherapy (also called cryoablation) method was produced by James Arnot in England in 1945 to reduce the size of cancerous cells based on the theory that cold blood cells destroy the cells. Campbell White of New York City used cryotherapy as the first dermatological indication in early-stage epithelioma patients in 1890. Later in 1907, Whitehouse described the use of this method in diferent diseases such as pigmented nevus and lupus. In addition, he has published a case series of skin cancers in different face regions.
15790012|NCT04532840|Other|Exercising, Positioning and splinting, Pressure Therapy and Massage|Exercising, Positioning and splinting, Pressure Therapy and Massage
15790013|NCT04532827|Behavioral|Case formulation with web-program|"The first meeting includes an interview to establish understanding on the participant´s symptomatology and current life situation, a case formulation (CF) will be build based on it. The CF is presented in the second session and modifications can be made to ensure acceptability for the participant. Goals for web program (WB) are set based on the CF and understanding of the factors contributing to the participant´s wellbeing.
~WB modules are instructed to complete during the first week and to continue to integrate the content into daily life during the second week. Modules include psychoeducation, experiential exercises and training aimed at improving wellbeing and psychological flexibility. Web-therapist will offer written feedback. The participants can contact the therapist via the WB and al messages will be replied within one week. Automatic reminders will be sent if a participant has not been active in the WB, the therapists will call participants who have discontinued using the WB."
15790014|NCT04532814|Other|Exercise|Cycling 60% VO2 max
15790015|NCT04532801|Drug|Kisspeptin-10|kisspeptin-10 IV infusion
15790016|NCT04532801|Other|mixed meal tolerance test|mixed meal tolerance test
15790017|NCT04532788|Procedure|Customized crosslinking|"In the customized corneal cross-linking protocol (cCXL) a patient-specific treatment pattern, based on the patient's Pentacam images, will be used to treat the cornea. The CXL pattern exists out of 3 concentric circles and is centered on the cone. To estimate the cone location a combination of the thinnest corneal point, maximum anterior elevation and maximum posterior elevation is used. The epithelium is debrided with alcohol within the marked zone. After the application of riboflavin each circle receives a different amount of energy, which gradually decreases with increasing circle size.
~The procedure is done with the Avedro Mosaic CXL device (Avedro, Inc. Waltham, Massachusetts, United States)."
15790018|NCT04532788|Procedure|Standard crosslinking|"In the standard corneal cross-linking protocol (sCXL) the epithelium is debrided with alcohol over a region with a diameter of 9.0 mm. After the application of riboflavin the cornea is irradiated with UVA with a fluence of 10 mW/cm2 during 9 minutes with a diameter of 9.0 mm, resulting in a total energy of 5.4 J/cm2.
~The procedure is done with the Avedro Mosaic CXL device (Avedro, Inc. Waltham, Massachusetts, United States)."
15790019|NCT04532775|Drug|magnesium|Preservative free magnesium which was used in the study was prepared in McGuff Pharmaceuticals, Inc. Laboratories and supplied in 50 ml vials containing magnesium (200 mg/ml).
15790020|NCT04532775|Drug|Methylprednisolone|Methylprednisolone which was used in this study was supplied from E.I.P.I.C.O pharmaceuticals -Egypt under license of UPJOHN s.a Puurs-Belgium (Depo-Medrol).
15790021|NCT04532775|Drug|Bupivacaine Hydrochloride|local anesthetic drug
15790022|NCT04532775|Drug|saline 0.9%|solution for intravenous and epidural injection
15790023|NCT04532762|Device|nasal spray|Application of a nasal spray
15790026|NCT04532736|Drug|Emthexate|After randomization, the patients were divided into three groups including 14 volunteers in each study groups and 11 in the control group. One of the study groups was take methotrexate (n=14, eight weeks) and the other was take methylprednisolone (n=14, eight week)
15790027|NCT04532736|Drug|Prednol|After randomization, the patients were divided into three groups including 14 volunteers in each study groups and 11 in the control group. One of the study groups was take methotrexate (n=14, eight weeks) and the other was take methylprednisolone (n=14, eight week)
15790028|NCT04532736|Drug|Mometasone Furoate|After randomization, the patients were divided into three groups including 14 volunteers in each study groups and 11 in the control group. One of the study groups was take methotrexate (n=14, eight weeks) and the other was take methylprednisolone (n=14, eight week)
15790029|NCT04532723|Device|ExoAtlet II|ExoAtlet II is the second version of an exoskeleton that ExoAtlet has manufactured
15790030|NCT04532710|Drug|Eye Drops, Solution in Single-Dose Container|Application of eye drops
15790031|NCT04532697|Other|Uncaria Rhynchophylla (Gou-Teng)|Uncaria Rhynchophylla (Gou-Teng) is a kind of Chinese Medicine. All eligible subjects will be randomly assigned to receive a treatment of either Uncaria Rhynchophylla or placebo for 16 weeks followed by 8 weeks observation. The patient will be asked to take 1.2 g of the granule in the morning and another 1.2 g in the evening.
15790032|NCT04532697|Other|Placebo|All eligible subjects will be randomly assigned to receive a treatment of either Uncaria Rhynchophylla or placebo for 16 weeks followed by 8 weeks observation. The patient will be asked to take 1.2 g of the granule in the morning and another 1.2 g in the evening.
15790033|NCT04532684|Drug|Duloxetine|
15790034|NCT04532684|Drug|Pregabalin|
15790035|NCT04532671|Other|Poly ether ether ketone (PEEK)|PEEK has been used in dentistry so far in certain fields as for, removable and fixed dental prostheses, implants, and implant abutments as well as orthodontic devices, whereas in literature, it is mostly mentioned in relation to prosthetics. PEEK was predominantly processed out of CAD/CAM-supported milled out of prefabricated blanks. Producing dental restorations via Additive manufacturing is still hardly widespread
15790036|NCT04532671|Other|CADCAM Poly ether ether ketone (PEEK)|Increased demand for long-lasting restoration's properties have led to many improvements in the production techniques of posterior restorations such as CAD/CAM systems. This technique simplifies the production of indirect restorations and make it possible to use advanced materials as PEEK
15790037|NCT04532671|Other|indirect resin composite|CADCAM resin composite blocks using milling process
15790038|NCT04532658|Behavioral|Coaching program|"Charting system for outcomes feedback
~Profiling of individual surgeon
~Modules of improvement"
15790039|NCT04532645|Drug|Olaparib|Olaparib
15790040|NCT04532619|Behavioral|Fathering Through Change|Fathering Through Change is an adaptation of Parent Management Training Oregon. This pilot provides a limited version of Fathering Through Change via text messaged and emailed weekly video content and includes individual coaching calls.
15790041|NCT04532606|Drug|Remimazolam|Remimazolam is administered intravenously for anesthesia induction and maintenance. The dose and infusion rate is adjusted to maintain BIS value between 40 and 60. Analgesia is maintained with remifentanil and/or sufentanil. Muscle relaxation is maintained with rocuronium and/or cisatracurium. Sevoflurane inhalation is provided when considered necessary.
15790042|NCT04532606|Drug|Propofol|Propofol is administered intravenously for anesthesia induction and maintenance. The dose and infusion rate is adjusted to maintain BIS value between 40 and 60. Analgesia is maintained with remifentanil and/or sufentanil. Muscle relaxation is maintained with rocuronium and/or cisatracurium. Sevoflurane is provided when considered necessary.
15790043|NCT04532593|Procedure|autologous adipose stem cell injection|Abdominal or buttock fat will be aspirated under local anesthesia or general anesthesia by conventional methods (0.5 ml fat was aspirated per 1 cm2 of skin graft area). The matrix component rich in adipose stem cells will be obtained by chopping, washing and centrifugation. The intervention treatment will be performed after the skin graft sutured. The stem cell components will be injected underneath the skin graft (0.05 ml/cm2).
15790044|NCT04532593|Procedure|saline injection|saline will be injected underneath skin graft (0.05 ml/cm2).
15790045|NCT04532580|Device|Diagnosis of fracture on X-Ray Radiographs|Diagnosis of fracture on X-Ray Radiographs with and without the assistance of Boneview Software
15790046|NCT04532567|Drug|GLPG1205|GLPG1205 film-coated tablets
15790047|NCT04532567|Drug|Placebo|placebo film-coated tablets
15790048|NCT04532554|Drug|Growth Hormone|Recombinant growth hormone will be used
15790049|NCT04532554|Drug|Placebo|Saline injection with the same amount
15790050|NCT04532541|Other|Monogenic lupus screening|This is an observational study, and there is no intervention. This study intends to obtain the incidence of monogenic lupus in childhood onset SLE through gene test and bioinformatic analysis.
15790051|NCT04532528|Drug|Dabigatran|Dabigatran
15790054|NCT04532502|Drug|Anesthetics, Inhalation|Work environmental exposure
15790055|NCT04532489|Drug|FNP-59|FNP-59, a radiotracer, is administered for PET/CT scans.
15790056|NCT04532476|Device|Low level laser therapy|"Diode laser (Laser HF, Hager-Werken GmbH & Co., Duisburg, Germany) was applied to the RIGHT side. Laser was set at PDT mode (660nm) acupuncture therapy. The power of the laser was set at 90 mW in intervals of 80 seconds as recommended by the manufacturer.
~The laser was applied perpendicular in contact with the mucosa on 1 point of the buccal and 1 point on the palatal side of the first molar approximately on the middle part of the root, with the 10mm distance from the laser to the mucosa. Each point was treated in 3 intervals, 80s each, in total 240s on vestibular and 240s on the palatal side per tooth. The treated surface was 1cm2. The power of the laser was 90mW, wavelength 660n, beam area 1 cm2, irradiance per target 0.09 W/cm2, during 240 seconds of treatment interval per point- 21.6J/cm2 of energy was delivered.
~The same laser treatment was performed the next day, as the pain was noted to be highest within 24 hours after the placement of separators."
15790057|NCT04532463|Drug|Amphotericin B 1 mg/kg 1 week & Flucytosine 100 mg/kg 1 week followed by Fluconazole 1200 mg/day 1 week|To study the clinical effectiveness and safety of amphotericin B with flucytosine-fluconazole therapy for cryptococcal meningitis in patients with HIV infection.
15790058|NCT04532450|Device|Branched / fenestrated aortic stent graft|Endovascular repair of an aortic aneurysm with a branched/fenestrated stent graft to revascularise all visceral arteries together with exclusion of the aortic aneurysm.
15790087|NCT04532203|Drug|CAR-T cells|Each subject receive CAR T-cells by intravenous infusion
15790088|NCT04532203|Procedure|Ommaya Reservoir|Surgical catheter placement into the fourth ventricle of the brain
15790089|NCT04532190|Device|rTMS|Repetitive transcranial magnetic stimulation (rTMS)
15790059|NCT04532437|Other|artificial intelligence-based skin aging simulation|Photographs of the volunteers' facial skin will be taken in the Department of Dermatology at baseline using a modern skin analysis photo system (VISIA®, Canfield Scientific, Parsippany, NJ, USA) and afterwards a simulation of the participants' facial skin aging will be performed with the VISIA® photo analysis System.
15790060|NCT04532437|Other|electronic questionnaire 1|Electronic questionnaire about current sun-related knowledge and protective behaviours via link with smartphone before and after the skin aging simulation.
15790061|NCT04532437|Other|electronic questionnaire 2|Participants report their perception of the interventions and their motivation for improved sun protection by completing an electronic questionnaire after the skin aging simulation.
15790062|NCT04532424|Device|Transcranial magnetic stimulation|Non-invasive brain stimulation technique that is FDA-approved for the treatment of refractory depression, OCD and migraine.
15790063|NCT04532411|Other|Personal Protective Testing Booth|Health personnel who utilize the Hexapod will remain in the booth and utilize durable gloves attached to ports through a plexiglass wall in order to administer a nasal swab for SARS-CoV-2 (COVID-19) testing. Patient escorts and housekeeping/sanitation staff perform additional tasks outside of the booth such as escorting the patient to the correct testing bay and dropping off testing vials and printed information, collect samples and deposit in the appropriate location after testing is complete, and sanitizing the patient bay before a subsequent patient is tested there.
15790064|NCT04532398|Other|Gugging swallowing screen - ICU (GUSS-ICU) index test|"Gugging swallowing screen - ICU (GUSS-ICU) index test:
~Screening for post-extubation dysphagia: GUSS-ICU performed by 2 speech therapists independently. The GUSS-ICU model contains the core features of the original GUSS tool with the added assessment items specific to the ICU Patient (RASS score (Richmond Agitation and Sedation Scale)).
~Stage one of the screen focuses on the preliminary investigation of indirect swallowing. Stage two is comprised of varying steps that directly test swallowing. This would include the administration of semisolids, water and bread with four distinct signs that were being assessed for - deglutition, coughing, drooling and voice change. The GUSS test is evaluated using a points system (0-10) which determines the severity of dysphagia and recommends a diet form that largely minimizes the risk of aspiration. (e.g. 10 points: No dysphagia = normal food)."
15790065|NCT04532398|Other|Flexible Endoscopic Evaluation of Swallowing (FEES) reference test|"Flexible Endoscopic Evaluation of Swallowing (FEES) reference test:
~Flexible Endoscopic Evaluation of Swallowing (FEES) is a technique to directly view the pharynx, larynx and esophagus during swallowing. The swallowing test is carried out first with saliva and then with different consistency (liquid, pulpy, solid) and different sized swallowing portions. This reference test is performed independently from the GUSS-ICU index test."
15790066|NCT04532385|Dietary Supplement|Green tea extract|400 mg capsule
15790067|NCT04532385|Dietary Supplement|Placebo|400 mg capsule
15790068|NCT04532372|Other|Best Practice|Receive standard of care drugs
15790069|NCT04532372|Drug|Leflunomide|Given PO
15790070|NCT04532372|Drug|Placebo Administration|Given PO
15790071|NCT04532359|Device|Implant placement|Implant placement
15790072|NCT04532346|Drug|Hydroxychloroquine|Hydroxychloroquine Sulfate is an anti-malarial and anti-rheumatic drug. hydroxychloroquine has been reported to improve the clinical status of chILD cases wtih genetic causes. The exact mechanism of action of hydroxychloroquine is unknown. In additon to having anti-inflammatory properties, hydroxychloroquine has been shown to affect intracellular processing of surfactant protein.
15790073|NCT04532333|Drug|Bivalirudin 250 MG Injection|Bivalirudin 0.75 mg/kg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg/kg/h until end of the procedure
15790074|NCT04532333|Drug|Heparin|Heparin should be administered each hour, 0.6mg/kg(75U/kg) as bolus dose, 0.3mg/kg 1h later, 10mg(1250U) every hour after.
15790075|NCT04532307|Behavioral|Standard of Care SOC|Research assistants refer the consenting participants to Isisekelo Sempilo adolescent and youth friendly services with HIV testing, treatment if positive and PrEP eligibility screening and offer if negative and family planning
15790076|NCT04532307|Behavioral|SRH enhanced Isisekelo Sempilo|Self-collected vaginal and urine samples are collected at enrolment. Research assistants then provide an Isisekelo Sempilo clinic referral appointment for results, treatment, HIV testing, sexual health, fertility, and family planning counselling, including the personal benefits of ART and Undetectable=Uninfectious among those infected, and PrEP for those eligible and who are negative.
15790077|NCT04532307|Behavioral|Peer-support (Thetha-Nami)|The research assistants refer the participant to a Thetha Nami peer-navigator in their community. Peer navigators will assess their health, social and educational needs, provide mentorship, and help them access the services they need. The peer navigator will facilitate attendance, adherence and retention at the Isisekelo Sempilo clinic.
15790078|NCT04532307|Behavioral|SOC + SRH + peer-support|A combination of interventions 2 and 3, to include both self-collected STI testing, nurse led testing and counseling, and referral to a Thetha Nami peer navigator to encourage clinic attendance and sexual health promotion.
15790079|NCT04532294|Drug|BGB DXP593|Administered intravenously (IV) as specified in the treatment arm
15790080|NCT04532294|Drug|Placebo|Placebo to match BGB-DXP593
15790081|NCT04532281|Drug|Murine CD19 CAR-T cells|Each subject receive murine CD19 CAR T-cells by intravenous infusion
15790082|NCT04532268|Drug|Humanized CD19 CAR-T cells|Each subject receive humanized CD19 CAR T-cells by intravenous infusion
15790083|NCT04532242|Behavioral|Cognitive reappraisal|Participants will be trained to follow instructions to look/respond naturally or use cognitive reappraisal to reframe or reconsider a negative picture to decrease negative emotion.
15790084|NCT04532229|Drug|Nimotuzumab+CRT(concurrent IMRT and TMZ)|"Drug: Nimotuzumab Concurrent radiochemotherapy period, 150mg/m2, weekly, for 6 weeks; Maintenance period, from the 7th to the 52nd week, 150mg/m2, every two weeks until disease progression or intolerable toxicity.
~Other Names: h-R3
~Drug: Temozolomide Concurrent radiochemotherapy period, 75mg/m2, daily, for 6 weeks; Maintenance period, rest from the 7th to 10th weeks, from the 11th week, 150-200mg/m2, day1 to day5, 21 days for a cycle, for 6 cycles.
~Other Names: TMZ"
15790085|NCT04532216|Procedure|Arthroscopic-Assisted Acromioclavicular Joint Reconstruction Using the TightRope Device|Arthroscopic-assisted AC joint reconstruction with the TightRope device with allograft augmentation and with the patient in the lateral decubitus position is a method of restoring joint stability
15790086|NCT04532216|Procedure|Traditional surgery|Tendon transfer
15790090|NCT04532177|Radiation|Stereotactic Body Radiation Therapy (SBRT)|fractionated linear accelerator based SBRT to 40 Gy in 5 fractions
15790091|NCT04532164|Drug|Butenafine HCl 1% (BAY1896425) - Induction Phase|To each of two test sites, approximately 20 μl/cm^2 of the Butenafine HCl 1% was applied directly to the skin and covered with a 25 mm Hilltop chamber with a Webril pad (2 cm in diameter, within an area of approximately 3 cm^2), and tape was applied over the chamber to secure the occlusive patch to the skin. On the next day, the chambers were removed and both test sites were lightly wiped. Approximately 2 μl/cm^2 of Butenafine HCl 1% was reapplied directly to the skin and lightly spread over the treated irradiated test site. The treated non-irradiated test site did not receive a similar reapplication. Between 5 and 15 minutes after application, the treated irradiated test site was irradiated with two times the subject's Minimal Erythema Dose (MED). Evaluation of the test sites occurred two days after the irradiation. This procedure was repeated two times per week for three consecutive weeks for a total of 6 induction exposures per test site.
15790092|NCT04532164|Drug|Butenafine HCl 1% (BAY1896425) - Challenge Phase|5 μl/cm^2 of the Butenafine HCl 1% was applied directly to each of the two virgin sites (treated sites) adjacent to the induction patch sites and covered with Hilltop chambers with Webril pad and tape was applied over the chambers to secure the occlusive patches to the skin. Two additional sites with no Butenafine HCl 1% (untreated sites) were also occluded. Sites were at least 2.5 cm apart. The patches were removed 24 hours later and the sites were lightly wiped. Test sites were evaluated. Butenafine HCl 1% (2 μl/cm^2) was applied to the treated irradiated site. After 15 minutes, the treated irradiated site and the untreated irradiated site were irradiated with 0.5 MED of UVA/UVB irradiation followed by 10 Joules/cm^2 of UVA from a xenon arc solar simulator equipped with a Schott WG345 to eliminate UVB radiation. The remaining sites served as the treated non-irradiated site and untreated non-irradiated site.
15790093|NCT04532151|Diagnostic Test|Non-invasive skin imaging assessment|"Intervention Description : (Limit: 1000 characters) Do not repeat information already included in arm/group descriptions. Specify details not covered in associated Arm
~One session of Non-invasive skin imaging assessment contained:
~an examination on LC-OCT
~an examination on LC-OCT-doppler
~a fluid silicone molding
~an examination on HD ultrasound
~The measurements will be applied on 3 skin sites: the dorsal surface of the finger, the inner face and the outer surface of the forearm.
~The imaging assessment lasts 30 minutes in a dimly lit room where the humidity and temperature are stable."
15790094|NCT04532138|Device|VS-CMAC Rigid Fiberoptic Stylet|patients with severe predicted difficult airways scheduled for elective surgery randomized to this groups will receive awake endoscopic intubation using VS-CMAC Rigid Fiberoptic Stylet.
15790095|NCT04532138|Device|C-MAC Video laryngoscope awake intubation|patients with severe predicted difficult airways scheduled for elective surgery randomized to this groups will receive awake endoscopic intubation using C-MAC Video Laryngoscope intubation.
15790096|NCT04532125|Biological|ARGX-117|Subjects treated with ARGX-117
15790097|NCT04532125|Other|Placebo|Subjects treated with placebo
15790098|NCT04532125|Biological|ARGX-117 + rHuPH20|Subjects treated with a combination of ARGX-117 and rHuPH20
15790099|NCT04532125|Other|placebo+rHuPH20|Subjects treated with a combination of placebo and rHuPH20
15790100|NCT04532112|Device|Biocontainment Device For Aerosol Generating Procedures (Biobox)|The intervention consists of a biocontainment and aerosol evacuation device (Biobox) that will be placed around a patient prior to the airway procedure and remain in place throughout the airway procedure. The Biobox device is manufactured by National Flag and consists of a re-useable frame with a disposable, plastic torso drape. This is a new device that has not been used previously in a healthcare setting.
15790101|NCT04532112|Device|Control for aerosol generating procedures|There is no control device for the aerosol containment device. As such, intubation without a device will serve as the control/placebo arm for this trial.
15790102|NCT04532099|Device|Lehfilcon A contact lenses|Investigational soft contact lenses for daily wear worn in Part A of the study
15790103|NCT04532099|Device|Senofilcon A contact lenses|Commercially available soft contact lenses for daily wear worn in Part A of the study
15790104|NCT04532099|Device|Comfilcon A contact lenses|Commercially available soft contact lenses for daily wear worn in Part B of the study
15790105|NCT04532099|Device|Hydrogen peroxide-based cleaning and disinfecting solution|For nightly cleaning and disinfecting of contact lenses in Part A and Part B of the study
15790106|NCT04532086|Diagnostic Test|Uterocervical angle|Transvaginal ultrasound examination will be performed at 18-28 weeks gestation in (197) pregnant women with live singleton fetuses, attending routine prenatal care services. Measuring length of uterine cervix at (18-28) weeks & evaluation of dilatation of internal os & measurement of uterocervical angle between(18-28)weeks gestational age.
15790107|NCT04532073|Other|Eurythmy Therapy|A mindfulness-oriented movement therapy
15790108|NCT04532073|Other|Tai Chi|A martial art developed in China, which in recent times is often regarded as a system of movement theory or gymnastics
15790109|NCT04532073|Other|Standard Care|Treatment process that a clinician should follow for a certain type of patient
15790110|NCT04532060|Drug|Nystatin|
15790111|NCT04532060|Procedure|Antimicrobial Photodynamic Therapy|
15790112|NCT04532047|Drug|Aldurazyme (laronidase)|Enzyme replacement therapy for lysosomal storage diseases
15790113|NCT04532034|Behavioral|Peer-Delivered Decision Support Intervention|An intervention provided by a trained peer interventionist to facilitate treatment decision making among emerging adults with early psychosis. Specific components of this intervention may include facilitating access to information, clarifying values, helping a person obtain the needed support to make a decision, and screening for implementation barriers. Due to having lived experience of a mental health condition, the peer interventionist will also be able to provide unique types of information and support within the coaching process.
15790114|NCT04532021|Diagnostic Test|matrix metalloproteinase 14, neopterin, and orosomucoid 1 measurements|These three markers levels will be measured using a commercially available enzyme-linked immunosorbent assay (ELISA) kit.
15790115|NCT04532008|Behavioral|Group based treatment|12 sessions of group based therapy that included cognitive restructuring, behavioral activation, and interpersonal therapy
15790140|NCT04531813|Drug|Positive Control-Sodium lauryl sulfate (SLS)|Approximately 0.2 mL of 0.3% solution of sodium lauryl sulfate was applied to the absorbent pad portion of a semi-occlusive dressing, which was then applied to the Positive Control test site.
15790141|NCT04531813|Other|Negative Control|A blank patch was applied to the Negative Control test site.
15790116|NCT04531995|Device|CANKADO PRO-React Onco|CANKADO PRO-React Onco is approved as class I medical device within the European Union (registration number DE /CA59 /371/2020-R/Hd) and is compliant with the FDA classification for Mobile Medical Devices (2015) Appendix B. The purpose of CANKADO PRO-React Onco is to be an automated digital support for patients to help them decide how urgent it is to contact the attending physician based on the symptoms they independently record in the system. It supports patients with cancer under systemic, anti-tumor or anti-hormonal therapy in adjuvant, neoadjuvant, post-neoadjuvant or palliative situations. It is unsuitable for patients undergoing radiotherapy, cell and gene therapy, surgical procedures or alternative healing methods.
15790119|NCT04531969|Other|Spa therapy and conventional physical therapy|"HP application +deep heater application + TENS. HP application: A hotpack wrapped in a towel for 20 minutes will be placed on the knee and surrounding soft tissues.
~Deep heater application: The application will be performed with a therapeutic ultrasound device at a dose of 1.5watt / cm2 for each string for 6 minutes.
~TENS application:TENS device with two electrodes surrounding tendon will be performed for 30 minutes at low-frequency current application.
~Spa therapy: A conventional water bath water at 38 ° C will be applied in the pool for 20 minutes a day."
15790120|NCT04531956|Other|Diagnostic decision aid s-decided|The intervention will consist of implementing a patient decision aid (PtDA) in general practice. The patient decision aid will be developed in line with the systematic development process specified by the International Patient Decision Aids Standards (IPDAS)
15790121|NCT04531943|Drug|Estrogen|Feminizing hormone therapy consisting of estrogen alone, as prescribed by the participant's healthcare provider.
15790122|NCT04531943|Drug|Estrogen plus Progesterone|Feminizing hormone therapy consisting of estrogen and progesterone, as prescribed by the participant's healthcare provider.
15790123|NCT04531930|Procedure|surgery|Colorectal surgery, mainly total proctocolectomy.
15790124|NCT04531930|Procedure|enhanced colonoscopy|Colonoscopic treatment and surveillance in every 3 months.
15790125|NCT04531930|Other|self choosed methods|A patient chooses a method for himself other than surgery.
15790126|NCT04531917|Other|Pain Neuroscience Education|Pain Neuroscience Education (PNE) teaches patients about complex pain mechanisms known to be of importance in pain following breast cancer such as malfunctioning of the endogenous analgesic system and pain memories.
15790127|NCT04531917|Other|Behavioural Graded Activity|"Patients in the experimental group will receive a behavioural treatment integrated within the concepts of operant conditioning. The purpose of Behavioural Graded Activity (BGA) is to increase the level of physical activity in the patient's daily lives in a time-contingent manner. On top of that, a healthy behaviour will be positively reinforced to consequently create a withdrawal of the attention towards pain behaviour, which is seen as an unreliable alarm sign in chronic pain patients. The implementation of BGA after PNE is described in the guideline reported by the International Association for the Study of Pain."
15790128|NCT04531917|Other|Usual care|The content of the leaflet has a biomedical approach in explaining pain and providing information on the different pain medication classes. This leaflet is mostly available in waiting rooms of oncology centres and units of the Flemish part of Belgium.
15790129|NCT04531904|Device|EMBOVAC Aspiration Catheter|The EMBOVAC Aspiration catheter is used to treat acute ischemic stroke. . The catheter can be used to facilitate introduction of diagnostic or therapeutic agents and is also intended for use in removal/aspiration of emboli and thrombi from selected blood vessels in the neuro vasculature.
15790130|NCT04531891|Other|Fatigue protocol|During the fatigue protocol, participants will sprint forward 5 m, cut at a 90° angle, sprint forward another 5 m, and backpedal 5 m. This activity will be repeated 4 times before participants will complete a series of hurdle activities. First, they will perform 2-legged jumps over 5 hurdles that are 30 cm high, turn, and repeat the jumps. Second, they will perform side-stepping exercises over the 5 hurdles. Third, they will complete four 5-m lateral shuffles.
15790131|NCT04531878|Drug|4-Phenylbutyrate|4-phenylbutyrate therapy will be started at a daily dose of 200 mg kg/d divided in 2 oral doses of sodium phenylbutyrate (AMMONAPS, Swedish Orphan Inter AB). In order to get the best effect, the dose will be increased up to a maximum of 500 mg kg/d.
15790132|NCT04531865|Drug|Rituximab|Rituximab: 375 mg/m2 intravenously on day 0 and day 7
15790133|NCT04531865|Drug|Mycophenolate Mofetil|Addition of Maintenance Mycophenolate Mofetil from 4 Month onwards. Dose: 20~30mg/kg/day，BID. Total duration : 8 months.
15790134|NCT04531865|Drug|Placebo tablets matching Mycophenolate Mofetil|Addition of Maintenance Placebo tablets matching Mycophenolate Mofetil from 4 Month onwards. Dose: 20~30mg/kg/day，BID. Total duration : 8 months.
15790135|NCT04531852|Other|CALSTI - Complex Active Lifestyle Intervention|"A group-based exercise (EX) and health empowerment program (HEP) conducted in the local area.
~Structured, progressive resistance (55-60%), balance (10-15%), endurance (10-15%) exercise was delivered twice weekly for 12 weeks under supervision of a trained instructor.
~HEP consists of 8 group sessions aiming to facilitate long-term behaviour change, by empowering older citizens to act on current risk behaviours (i.e. low physical activity/exercise, high sedentary behaviour, social isolation, poor dietary habits, incontinence). Four sessions were conducted during the exercise intervention period (phase 1 - intensive), and four sessions in the following 12 weeks (phase 2 - maintenance)."
15790136|NCT04531852|Behavioral|SEMAI - Self-Management Intervention|A low-cost enhancement of the existing preventive service where citizens are information about relevant health resources. Citizens allocated to SEMAI intervention are offered the health-empowerment program as outlined above, including four extra sessions dedicated to practical experiences with exercising. 24 weeks duration in total, with eight sessions in phase 1 and four sessions in phase 2
15790137|NCT04531839|Behavioral|Evidence-based collaborative quality improvement|Evidence-based collaborative quality improvement interventions including benchmarking, potential better practice list, PDSA implementation and collaborative learning
15790138|NCT04531826|Other|5-strand hamstring graft preparation|Five-strand hamstring graft preparation
15790139|NCT04531813|Drug|Butenafine HCl 1% (BAY1896425)|Approximately 0.2 g of cream containing butenafine HCl 1% daily (excluding weekends) was applied to the absorbent pad portion of a semi-occlusive dressing, which was then applied to the skin test site. The total dose applied to each participant completing the trial was 3 g.
15790142|NCT04531800|Procedure|Concentrated growth factor|In the concentrated growth factor (CGF) group, CGF was applied to the surgical area (n=14), and the area was primarily closed after additional releasing incisions.
15790143|NCT04531800|Procedure|Non-concentrated growth factor|In the non-CGF group, the surgical area was only primarily closed without any mobilization of the flap following sequestrectomy and bone curettage as a traditional surgical therapy.
15790144|NCT04531787|Drug|Influenza vaccine|influenza vaccine 0.5 ml intramuscularly each season: 2004-2005, 2005-2006, 2006-2007, 2007-2008 for season specific A/H1N1, A/H3N2, and B antigens
15790145|NCT04531774|Behavioral|RECHARGE|"RECHARGE is an abbreviated and adapted version of Problem Management Plus (PM+), an evidence-based intervention that helps to cope with stress in times of crisis. Recharge is specifically developed for HCWs as a brief psychological intervention for adults affected by adversity emerging from stress exposure and teaches people three well-documented strategies to manage acute stress. The strategies are: a) managing stress, b) managing worry, c) meaningful activity. It includes psychoeducation, arousal reduction techniques, managing worries and problem-solving skills, behavioural activation, enhancement of meaningful activities, and relapse prevention, which are all based on the principles of cognitive-behavioural therapy.
~RECHARGE is delivered online in a 1 to 1 setting between coach and participant. Trained peers (medical doctors, nurses, psychologists) act as coaches."
15790146|NCT04531774|Behavioral|Self Study|HCWs are referred to a few recommended webpages that outline well-validated, adaptive coping strategies for managing stress.
15790147|NCT04531761|Behavioral|Parent Support Program|The parent support program includes three modules aimed at increasing knowledge, positive attitudes, and supportive behaviors towards trans youth. Each online module includes several activities including writing prompts, videos, interactive quizzes, and other educational activities.
15790148|NCT04531748|Drug|Toremifene|Participants will be instructed to take 60mg of oral toremifene capsule daily, 30 minutes before bedtime.
15790149|NCT04531748|Drug|Melatonin|Participants will be instructed to take the pills orally around the same time in the morning and 30 minutes prior to bedtime in the evening.
15790150|NCT04531748|Other|Placebo|Oral placebo will be used with the same number and appearance to the pills as the interventions.
15790151|NCT04531722|Procedure|Intraoperative brain microdialysis|Our current standard practice is to use a lateral approach through the middle temporal gyrus to place 3 depth electrodes targeting the hippocampus for intraoperative verification of pathological epileptiform activity prior to resection. Our research protocol will add one FDA approved electrode that has a central cannula for insertion of a microdialysis probe.
15790152|NCT04531709|Other|Comprehensive Score for financial toxicity (COST)|Measure indirect and direct health care cost that burden patients and their loved ones.
15790153|NCT04531709|Other|Functional Assessment of Cancer Therapy: General (FACT-G)|General quality of life instrument
15790154|NCT04531709|Other|EORTC QLQ C-30|Assess quality of life in cancer patients
15790155|NCT04531709|Other|EORTC QLQ-TC26.|To measure disease and treatment related quality of life issues relevant to testicular cancer patients that were not explored in the QLQ-C30 questionnaire.
15790156|NCT04531696|Procedure|Blood draw|Blood draw at inclusion
15790157|NCT04531696|Procedure|Post-mortem tissue collection|Sample collection (both liquids, tumour tissue and non-tumour tissue) during post-mortem research autopsy
15790158|NCT04531683|Other|electroacupuncture|same as described in experimental arm.
15790159|NCT04531683|Other|sham electroacupuncture|same as described in sham comparator.
15790160|NCT04531683|Behavioral|life style counselling|life style counselling to patients with mixed urinary incontinence contains advice on daily drinking, caffeine intake, diet, constipation, exercise, heavy lifting, lung disease, urinary track infection and etc.
15790161|NCT04531670|Behavioral|iRaPID|Participants randomized to the iRaPID program will receive: a) same-day access to PrEP and OAT and educational counseling by the APN; b) safety-check phone calls/SMS; c) follow-up phone call/SMS; and d) clinical visit at Day 30
15790162|NCT04531670|Other|Standard of Care|PWID participants randomized to the training as usual (TAU) will follow the existing clinical guidelines to receive PrEP, OAT, or both.
15790163|NCT04531657|Drug|Influenza vaccine|influenza vaccine 0.5 ml intramuscularly during 2008-2009 season for measurement of A/Brisbane/59/2007(H1N1)-like, A/Brisbane/10/2007(H3N2)-like, and B/Florida/4/2006-like antigens
15790164|NCT04531644|Procedure|double stimulation|the patients will be treated with two consecutive ovarian stimulations in one cycle
15790165|NCT04531644|Procedure|conventional ovarian stimulation|the patients will be treated with one conventional ovarian stimulation in one cycle
15790166|NCT04531631|Drug|Dorzagliatin|tablet
15790167|NCT04531631|Drug|placebo|placebo
15790168|NCT04531618|Behavioral|Family Nurture Intervention (FNI)|FNI is a family based intervention that facilitates and strengthens the mother-infant emotional connection through a structured guided interaction by a Nurture Specialist. The mother is asked to sit with her baby in her arms so that they are face-to-face, and when the baby becomes restless, the physician will coach the mom to bring the baby back to a calm state. The mother will also be encouraged to verbalize her feelings to her baby. Mother-infant emotional connection is known to affect various developmental processes and improve overall health. FNI was previously shown to be efficacious in improving several long-term health outcomes in preterm infants in the neonatal intensive care unit (NICU).
15790169|NCT04531605|Behavioral|YBank program|Adolescents participated in a 12-week peer-led life skills trainings at clinics and received financial incentives via mobile money upon clinic attendance and demonstration of suppressed viral load.
15790174|NCT04531566|Dietary Supplement|Oral Feed|Infant will be seen by occupational therapist (OT) twice a week and assessed for oral cues. If infant shows oral cues then the occupational therapist will proceed with feeding strategies. Oral feeding strategies include pacifier dips, open nipple trials with syringe controlled bolus size (1-4mls) and po trials up to 10mls.
15790175|NCT04531566|Dietary Supplement|Usual care|Infants will not start oral feeds until on HFNC 2 Litres or less. Oral feeds will be started on the discretion of the physician.
15790176|NCT04531553|Procedure|Thoracic epidural analgesia|Patients will preoperatively receive US guided ESP block on the side to be operates upon, the puncture point of the skin is infiltrated with 2% lidocaine, and once the structures are identified with ultrasound at the level of T5 transverse process, catheter inserted bupivacaine 0.1% dexmedetomidine 0.5 μg/mL infused at a rate of 6 mL/h for 48 hours.
15790177|NCT04531553|Procedure|ESPB with bupivacaine and dexmedetomedine|Patients will preoperatively receive US guided ESP block on the side to be operates upon, the puncture point of the skin is infiltrated with 2% lidocaine, and once the structures are identified with ultrasound at the level of T5 transverse process, we will inject bolus 20ml of bupivacaine 0.25% plus 0.5mic/ml dexmedetomidine on the deep aspect of erector spinae muscle then catheter inserted bupivacaine 0.1% and dexmedetomidine 0.5 μg/mL infused at a rate of 6 mL/h for 48 hours.
15790178|NCT04531553|Procedure|ESPB with bupivacaine|Patients will preoperatively receive US guided ESP block on the side to be operates upon, the puncture point of the skin is infiltrated with 2% lidocaine, and once the structures are identified with ultrasound at the level of T5 transverse process, we will inject bolus 20ml of bupivacaine 0.25% on the deep aspect of erector spinae muscle then catheter inserted bupivacaine 0.1%, infused at a rate of 6 mL/h for 48 hours.
15790179|NCT04531540|Drug|Butenafine HCl 1% (BAY1896425)|Approximately 0.2 g of cream containing butenafine HCl 1% were applied to the upper back skin.
15790180|NCT04531527|Drug|Butenafine HCl 1% (BAY1896425)|Approximately 60 μl of Butenafine HCl 1% applied twice to the treated irradiated site and to the treated non-irradiated site for a total application of 240 μl of Butenafine HCl 1%.
15790181|NCT04531514|Other|Sensitivity to phonological rules & referents: Toddlers|Assess whether the inclusion of a semantic referent explains the transition from OR to Family Resemblance phonological rule learning.
15790182|NCT04531501|Diagnostic Test|Saliva and NPS test|N/A Our study will not impact their path of care as they will be doing an NHS test which will determine their path of care at the NHS
15790183|NCT04531488|Procedure|Powered Mobility Training Simulator|Two groups of participants- 18 in each- were provided with either a simulator or powered wheelchair. Both groups were tested at baseline for powered mobility level. Both groups the practiced at home or school for 12 weeks, 4 times a week for at least 20 minutes. Both groups returned and underwent another evaluation to assess powered mobility level after 12 weeks of practice.
15790184|NCT04531488|Other|Training with Powered Wheel Chair|Training with Powered Wheel Chair
15790185|NCT04531475|Drug|X842|X842 capsules
15790186|NCT04531475|Drug|X842 Placebo|X842 placebo-matching capsules
15790187|NCT04531475|Drug|Lansoprazole|Lansoprazole capsules
15790188|NCT04531475|Drug|Lansoprazole Placebo|Lansoprazole placebo-matching capsules
15790189|NCT04531462|Drug|Empagliflozin|Empagliflozin
15790190|NCT04531462|Drug|Placebo|Placebo
15790191|NCT04531436|Other|Brief mindful eating intervention|Over the 9-week intervention, participants will be introduced to various mindful eating and intuitive eating practices which are aimed at reducing overeating and facilitating weight loss. Each session will focus on one simple, evidence-based message, aimed at modifying a current weight-relevant eating behavior of the patient. The intervention will focus on two key elements: (1) the mindful awareness of body cues (intuitive eating) and (2) the mindful awareness of external cues (mindful eating).
15790192|NCT04531423|Drug|SSRI + golimumab|Golimumab will be administered at the dose of 50mg every month during the acute phase.
15790193|NCT04531423|Other|SSRI + placebo|placebo
15790194|NCT04531410|Dietary Supplement|linoleic acid supplementation|Oils given daily at morning meal with extra enzymes
15790195|NCT04531410|Dietary Supplement|oleic acid supplementation|Oils given at morning meal with extra enzymes
15790196|NCT04531397|Drug|ACEI treatment|ACEI, will be given once daily based on body weight (0.2mg/kg/d-0.6mg/kg/d，max 20mg/d), for 24 weeks
15790197|NCT04531397|Drug|Dapagliflozin+ACEI treatment|Dapagliflozin will be given 10 mg/day (weight>30kg) or 5mg/day (weight≤30kg), for 24 weeks ACEI, will be given based on body weight (max 20mg/d), for 24 weeks.
15790198|NCT04531384|Device|robot-assisted rehabilitation intelligent treatment|robot-assisted rehabilitation psychotherapy
15790199|NCT04531384|Other|standard psychotherapy treatment|standard treatment at the compulsory isolated detoxification centers and non-compulsory isolated detoxification institutions
15790200|NCT04531371|Drug|Dexmedetomidine injection|post surgical agitation prophylaxis
15790201|NCT04531358|Device|nasal spray|application of nasal spray
15790202|NCT04531358|Other|no treatment|no treatment
15790203|NCT04531345|Diagnostic Test|Flow cytometric analysis|IL-1β, IFN-α2, IFN-γ, TNF-α, MCP-1 (CCL2), IL-6, IL-8 (CXCL8), IL-10, IL-12p70, IL-17A, IL-18, IL-23, IL-33 cytokine analysis of COvid-19 patients and healthy volunteers
15790204|NCT04531332|Drug|Continuous infusion Linezolid|Linezolid 600 mg intravenous Loading dose followed by 1200 mg/ day by Continuous infusion ( 50 mg /hr )
15790205|NCT04531332|Drug|intermittent dosing linezolid|Linezolid 600 mg intravenous twice daily
15790206|NCT04531319|Diagnostic Test|Flow cytometric analysis|Flow cytometric analysis of T helper, T cytotoxic cells, NK cells and monocytes
15790207|NCT04531306|Other|Kinesio® Tape|Fascial taping technique for myofascial trigger points on the iliotibial band
15790208|NCT04531293|Device|Respiratory Analysis System|Measurement of total lung capacity using total-breath method
15790209|NCT04531293|Device|Respiratory Analysis System|Measurement of total lung capacity using standard method
15790210|NCT04531280|Other|Home hospital care|Patients receive hospital-level care in their home.
15790211|NCT04531267|Dietary Supplement|Individualized dosage of calcium and magnesium|Participants' diet will be assessed by food frequency questionnaire to obtain calcium and magnesium intake. Individualized dosage of dietary supplements will be provided to maintain a calcium/magnesium ratio as 2.3. Participants will stay with the original medication plan.
15790212|NCT04531254|Behavioral|Personal behaviours|Personal behaviours and person-to-person interactions will be recorded using video cameras.
15790213|NCT04531241|Device|ACUVUE® OASYS 1-DAY|senofilcon A contact lenses made with a novel manufacturing technology
15790214|NCT04531241|Device|ACUVUE® OASYS 1-DAY|enofilcon A contact lenses made with the current manufacturing technology
15790215|NCT04531228|Procedure|TACE-HAIC plus lenvatinib|chemo-lipiodolization with EADM (30mg/m2), followed by FOLFOX-based chemotherapy artery infusion (Oxa 85mg/m2, 5-Fu 400 mg/m2, 5-Fu 1200mg/m2). Lenvatinib was administrated two or four days after TACE-HAIC, with 8mg for patients weight <60kg, or 12mg for patients weight more than 60Kg.
15790216|NCT04531215|Drug|ultrasound guided Retrolaminar Block|ultrasound guided Retrolaminar Block (RLB) with 20 ml (0.5% Bupivacaine) plus 5 mic/ml Adrenaline (1:200,000) at the level of T4 of the surgical side
15790217|NCT04531215|Drug|ultrasound guided Erector Spinae Plane|ultrasound guided Erector Spinae Plane Block (ESPB) with 20 ml (0.5% Bupivacaine) plus 5 mic/ml Adrenaline (1:200,000) at the level of T4 of the surgical side.
15790218|NCT04531176|Other|Weight Management Program (WMP)|Weight Management Program (WMP)
15790219|NCT04531176|Other|Traditional care|Traditional care
15790220|NCT04531176|Drug|Phentermine / Topiramate Extended Release Oral Capsule|Medication for chronic weight management (Rx)
15790221|NCT04531176|Drug|naltrexone/bupropion extended-release|Medication for chronic weight management (Rx)
15790222|NCT04531176|Drug|liraglutide 3.0 mg|Medication for chronic weight management (Rx)
15790223|NCT04531176|Drug|Orlistat|Medication for chronic weight management (Rx)
15790224|NCT04531163|Drug|N Acetylcysteine|(NAC) is a drug used in the experiment and participant are treated with it by 1200mg/day dose for two months.
15790225|NCT04531150|Drug|INV-101|Subjects will be randomized to receive INV-101 tablets
15790226|NCT04531150|Drug|Placebo|Subjects will be randomized to receive placebo tablets
15790227|NCT04531137|Dietary Supplement|CLA-fortified milk powder|3.4 gram of CLA-fortified milk powder one a day for 12 weeks
15790228|NCT04531137|Other|Placebo|Placebo milk powder one a day for 12 weeks
15790229|NCT04531137|Other|Nutrition Counseling|Individualized nutrition counseling using nutrition module at week 0, 4, and 8 for 30-45 minutes each session
15790230|NCT04531124|Other|integrated management|establish an integrated management on cardio-metabolic risk factors including hypertension by updating and upgrading the daily practice of practitioners and screening patients
15790231|NCT04531098|Biological|Sci-B-Vac-SciGen|Sci-B-Vac vaccine-10 μg of HBsAg, intramuscular injection of 10 μg/ml
15790232|NCT04531098|Biological|Sci-B-Vac-BTG|Sci-B-Vac OLD BTG - 10 μg of HBsAg, intramuscular injection of 10 μg/ml
15790233|NCT04531098|Biological|Engerix-B|ENGERIX-B (hepatitis B vaccine (recombinant)) is indicated for active immunization against hepatitis B virus infection
15790234|NCT04531085|Procedure|Operative treatment|Surgery
15790235|NCT04531085|Procedure|Long arm cast|cast immobilization
15790236|NCT04531072|Drug|Artemether-lumefantrine|Safety and efficacy evaluation during concurrent use of artemether-lumefantrine and atazanavir-ritonavir based antiretroviral therapy
15790237|NCT04531072|Drug|Atazanavir-ritonavir 300/100 mg|Safety and efficacy evaluation during concurrent use of artemether-lumefantrine and atazanavir-ritonavir based antiretroviral therapy
15790238|NCT04531059|Drug|Esomeprazole|Proton pump inhibitor
15790239|NCT04531059|Drug|Bismuth Potassium Citrate|Gastric mucosal protective drug with anti-H. pylori effect
15790240|NCT04531059|Drug|Tetracycline,Metronidazole|Antibiotics for H. pylori eradication
15790241|NCT04531059|Drug|Minocycline,Metronidazole|Antibiotics for H. pylori eradication
15790242|NCT04531046|Drug|axicabtagene ciloleucel|Patient-specific (autologous) product cryopreserved in cryostorage bag
15790243|NCT04531033|Dietary Supplement|Lactobacillus acidophilus MPH734|After supplementing with oral probiotics, it has been suggested that select probiotics capable of expressing Beta-glucosidase enzyme activity may likewise be effective treatment for lactose intolerance.
15790244|NCT04531033|Dietary Supplement|Placebo|placebo made to match dietary supplement being tested.
15790245|NCT04531020|Diagnostic Test|PAED measurement|The incidence of emergence delirium, defined as PAED score above 10 points minimally in one of the PAED score measurements. PAED score will be measured in 0., 5., 10., 15., and 20. minute after PACU admission.
15790246|NCT04531007|Diagnostic Test|iFR/ FFR/ IVUS/ OCT|intermediate lesion evaluation with intracoronary physiology and imaging
15790248|NCT04530981|Drug|Ripretinib|Oral KIT/PDGFRA kinase inhibitor
15790249|NCT04530981|Drug|Repaglinide|Oral antihyperglycemic agent
15790250|NCT04530968|Other|No intervention|No intervention
15790251|NCT04530955|Device|Prometra II Programmable Pump - Flowonix Medical|The valve gated Prometra II Programmable Pump will be replacing the prior peristaltic Synchromed II pump and a 20% dose decrease will be performed at the time of the replacement.
15790252|NCT04530942|Device|Deep brain stimulation(Active)|Active DBS with the optiomal parameters
15790253|NCT04530942|Device|Deep brain stimulation(sham)|Sham DBS with 0V Amplitude
15790254|NCT04530929|Dietary Supplement|SANPROBI BARRIER|Competitors used probiotic for three months at a dose of 2x2 capsules daily (2.5 x 109 CFU / g (1 capsule)).
15790255|NCT04530929|Dietary Supplement|PLACEBO|Competitors used placebo for three months at a dose of 2x2 capsules daily.
15790256|NCT04530916|Dietary Supplement|Blueberry Powder|22 g/day wild blueberry powder
15790257|NCT04530916|Dietary Supplement|Placebo Powder|22 g/day placebo powder
15790258|NCT04530903|Drug|Clonidine|75 µg (0.5mL) per injection site
15790259|NCT04530903|Drug|Levobupivacaine|0.25% (10 ml) per injection site
15790260|NCT04530903|Drug|NaCl 0.9%|Nacl 0.9% (0.5ml) per injection site
15790261|NCT04530890|Diagnostic Test|Blood samples|Only blood samples at different times of treatment
15790262|NCT04530877|Biological|Infliximab|Infliximab, a monoclonal antibody-targeting tumor necrosis factor (TNF), is one of the primary treatment strategies for active pediatric CD
15790395|NCT04529941|Device|Device Implant without Active Treatment|No device output for 2 weeks
15790263|NCT04530877|Dietary Supplement|Exclusive Enteral Nutrition|the administration of a liquid formula diet with the exclusion of all other regular food for 6-8 weeks， the volume was determined according to the energy needs of the patient. All patients received high energy intakes (>110%-120% of the average requirement).
15790264|NCT04530864|Drug|Dextenza 0.4Mg Ophthalmic Insert|All patients will receive pre-surgical ocular surface treatment with intracanalicular sustained release dexamethasone, 0.4 mg
15790265|NCT04530851|Procedure|ERAS|"Counseling
~H2- antagonist and metroclopramide for prevent aspiration
~Drink clear liquid until 2 hour before surgery
~First generation cephalosporin in 60 minute before surgery
~Clorhexidine for skin cleansing and Povidine for vaginal cleansing
~Regional anesthesia
~Keep warming
~Blunt expansion of uterine incision
~Do not peritoneal suture and subcuticular suture if less than 2 cm
~Local wound anesthesia.
~Paracetamol and NSAIDs for for pain control
~Early remove catheter and ambulation
~5-HT3 antagonist for prevent nausea"
15790266|NCT04530838|Biological|20-valent pneumococcal conjugate vaccine|20-valent pneumococcal conjugate vaccine
15790267|NCT04530838|Biological|13-valent pneumococcal conjugate vaccine|13-valent pneumococcal conjugate vaccine
15790268|NCT04530825|Other|Wait-List Control|-Will receive routine clinical care. After completion of follow-up measures, control participants will receive a behavior change prescription via the PREVENT tool
15790269|NCT04530825|Other|PREVENT Tool|-PREVENT is a novel Health Information Technology tool designed to promote physical activity and healthy food intake among overweight/obese adolescent patients at the point of care. PREVENT automates the delivery of personalized, evidence-based behavior change recommendations and provides an interactive map of community resources to help providers link patients to resources in their community.
15790274|NCT04530799|Other|Identification of biomarkers for IAPA via patient sampling|Blood, BAL, microbiome
15790275|NCT04530786|Drug|Influenza vaccine|"influenza vaccine 0.5 ml intramuscularly each season, antigens measured for 3 years following vaccination in:
~2004-2005: A/Wyoming H3N2; B/Shanghai
~2006-2007: A/New Caledonia H1N1
~2007-2008: A/Solomon Islands; A/Wisconsin H3N2; B/Malaysia"
15790276|NCT04530773|Behavioral|Watch VR movies/ Play VR games|The healthy individuals will watch VR movies or play VR games with different Physical parameters for 60 minutes.
15790279|NCT04530721|Other|no intervention|we don't do any intervention
15790280|NCT04530708|Radiation|Thoracic radiotherapy|36 Gy to the primary lung tumor and present mediastinal node metastases after three months of medical treatment.
15790281|NCT04530695|Other|Scaling and Root Planing|Periodontal treatment by scaling and root planing (SRP), deep cleaning
15790282|NCT04530682|Biological|Biological samples|Serum and plasma samples. At baseline, 6, 12 and 24 months
15790283|NCT04530669|Device|High Tone Power Therapy|"High Tone Power Therapy (HiTop 191): (For group I). The high tone power therapy through using a device (HiTop 191; gbo Medizintechnik, Rimbach, Germany).
~The intensity of the electrical stimulation will be adjusted to a pleasant level that did not produce any pain or discomfort."
15790284|NCT04530669|Other|exercise program|physical therapy conventional selected exercise program inform of functional activities of daily living
15790285|NCT04530656|Biological|Two doses of middle-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28|Two doses of middle-dose (20µg/ 0.5ml) recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28.
15790286|NCT04530656|Biological|Two doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28|Two doses of high-dose (40µg/ 1.0ml) recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 28.
15790287|NCT04530656|Biological|Three doses of high-dose recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28|Three doses of high-dose (40µg/ 1.0ml) recombinant SARS-CoV-2 vaccine (Sf9 Cell) at the schedule of day 0, 14, 28
15790288|NCT04530656|Biological|Two doses of placebo at the schedule of day 0, 28（middle-dose group）|Two doses of placebo (0.5ml) at the schedule of day 0, 28
15790289|NCT04530656|Biological|Two doses of placebo at the schedule of day 0, 28（high-dose group）|Two doses of placebo (1.0ml) at the schedule of day 0, 28
15790290|NCT04530656|Biological|Three doses of placebo at the schedule of day 0, 14, 28（high-dose group）|Three doses of placebo (1.0ml) at the schedule of day 0, 14, 28
15790291|NCT04530643|Drug|HY209 0.3%|25 subjects will be assigned to drug (HY209 0.3% gel).
15790292|NCT04530643|Drug|HY209 0.5%|25 subjects will be assigned to drug (HY209 0.5% gel).
15790293|NCT04530643|Drug|Placebo|25 subjects will be assigned to drug (Placebo).
15790294|NCT04530630|Drug|BIKTARVY 50Mg-200Mg-25Mg Tablet|A three-drug fixed dose combination tablet containing 50mg of bictegravir, 200mg of emtricitabine, and 25mg of tenofovir alafenamide.
15790295|NCT04530617|Drug|Camostat Mesilate|Tablets
15790296|NCT04530617|Drug|Artemisia Annua Leaf|Tea bags
15790297|NCT04530604|Drug|Defibrotide|"All patients will receive 25 milligram/kilogram/day (mg/kg/day) of defibrotide, given in 4 divided doses (approximately every 6 hours), each dose infused over 2-hours intravenously (IV).
~The planned duration of study therapy is 7 days (while in the hospital), with the following qualifications:
~Patients who respond to study therapy prior to day 7 (able to discontinue oxygen) will discontinue study therapy at that earlier time point.
~Patients who have not responded to study therapy by day 7 of therapy, evidenced by <20% reduction (or a worsening) of the amount of supplemental oxygen they are receiving, will discontinue study therapy at day 7.
~Patients who have evidence of a partial pulmonary response by day 7 (>20% reduction in supplemental oxygen requirement, but still require supplemental oxygen) may elect to continue to receive study drug through an additional 7 days of study (total 14-day therapy course)."
15790298|NCT04530591|Other|Survey|Participants will complete a survey about their opioid use history, its impact on their lives, their current strategies for preventing or reversing opioid overdoses, and their preferences for a device-based intervention.
15790299|NCT04530591|Other|Interview|"Participants will participate in a semi-structured interview, during which they will provide feedback on non-functional, looks-like prototypes of a naloxone delivery device."
15790300|NCT04530578|Drug|Heparin sodium|Nebulized Heparin every 8 hours plus Subcutaneous Enoxaparin every 24hours
15790301|NCT04530578|Drug|Enoxaparin|Subcutaneous Enoxaparine every 24 hours
15790313|NCT04530552|Drug|Apalutamide|Given PO
15790314|NCT04530552|Other|Quality-of-Life Assessment|Ancillary studies
15790315|NCT04530539|Dietary Supplement|Vitamin C|1000mg Vitamin C, at bedtime
15790316|NCT04530539|Dietary Supplement|melatonin|10mg melatonin, at bedtime
15790317|NCT04530539|Dietary Supplement|Placebo|Placebo at bedtime
15790318|NCT04530539|Other|Symptom Survey|Daily symptom survey to be completed by patient electronically
15790319|NCT04530513|Radiation|Stereotactic ablative radiotherapy - Level 1|6Gy x 2 fractions to all sites in 2 weeks
15790320|NCT04530513|Radiation|Stereotactic ablative radiotherapy - Level 2|6Gy x 3 fractions to all sites in 3 weeks
15790321|NCT04530513|Radiation|Stereotactic ablative radiotherapy - Level 3|6Gy x 4 fractions to all sites in 4 weeks
15790322|NCT04530513|Radiation|Stereotactic ablative radiotherapy - Level 4|6Gy x 5 fractions to all sites in 5 weeks
15790323|NCT04530513|Radiation|Stereotactic ablative radiotherapy - De-escalation Level|6Gy x 1 fraction to all sites in 1 week
15790324|NCT04530500|Genetic|COVID-19 Androgen Sensitivity Test (CoVAST)|The CoVAST Test is an in-vitro non diagnostic test. The test reports the genetic health risk of male patients in developing severe symptoms following COVID 19 infection. The genetic information provided by this test will help physicians evaluate the association of AR gene polymorphism with disease severity and mortality following COVID-19 infection. The CoVAST Test is indicated for reporting of the following variant associated with the following gene.
15790325|NCT04530487|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo HSCT
15790326|NCT04530487|Drug|Cyclosporine|Given IV and PO
15790327|NCT04530487|Drug|Etoposide|Given IV
15790328|NCT04530487|Drug|Fludarabine Phosphate|Given IV
15790329|NCT04530487|Biological|Lapine T-Lymphocyte Immune Globulin|Given IV
15790330|NCT04530487|Drug|Melphalan|Given IV
15790331|NCT04530487|Drug|Mycophenolate Mofetil|Given IV or PO
15790332|NCT04530487|Drug|Tacrolimus|Given IV and PO
15790333|NCT04530487|Drug|Thiotepa|Given IV
15790334|NCT04530474|Drug|Ivermectin Pill|Ivermecin as a one-time dose
15790335|NCT04530474|Drug|Placebo|Inactive medication as a one time dose
15790336|NCT04530461|Diagnostic Test|Serological test|Positive serological test of SARS Cov2
15790337|NCT04530448|Drug|Sodium bicarbonate|Sodium bicarbonate 225 mEq (225 mL of an 8.4% solution) intravenously over 1 hour. Sodium bicarbonate 8.4% solution should not exceed 900 ml (4 boluses) in 24 hours.
15790338|NCT04530448|Other|Standard of Care|Standard of Care treatment
15790339|NCT04530435|Device|PEP flute|Participants are advised to use a PEP flute at least three times daily at an appropriate resistance. Ideally, each session consists of 15 breaths (for approximately 1 minute) repeated twice at an upright position.
15790340|NCT04530422|Drug|Sofosbuvir plus Ledipasvir|"Sofosbuvir plus Ledipasvir, once daily for 15 to 21days
~Oseltamivir 150 mg q 12 hours for 10 days ;
~HCQ 400 q 12 hours for one day followed by 200mg q 12 hours for 9 days ; and
~Azithromycin 500mg once daily for 1 day , followed by 250mg once daily for 6 days."
15790341|NCT04530409|Drug|Early-Dexamethasone|early use of dexamethasone as early as laboratory evidence of high inflammatory markers
15790342|NCT04530409|Drug|Late-Dexamethasone|Use of dexamethasone on deterioration of the cases with increased severity
15790343|NCT04530396|Biological|Gam-COVID-Vac|vaccine for intramuscular injection
15790344|NCT04530396|Other|placebo|placebo comparator
15790346|NCT04530370|Biological|recovered covid 19 patients plasma|we transfused 150 ml of recovered covid 19 plasma to severely ill patients with confirmed covid 19 disease
15790347|NCT04530357|Biological|QazCovid-in® - COVID-19 inactivated vaccine|QazCovid-in® (inactivated) Vaccine manufactured by Research Institute for Biological Safety Problems Republic of Kazakhstan
15790348|NCT04530357|Other|Placebo|Placebo (sodium chloride bufus, solvent for the preparation of dosage forms for injection 0.9%) The use of placebo: intramuscularly, twice, spaced 21 days apart, at a dose of 0.5 ml (22 volunteers)
15790349|NCT04530344|Drug|ruxolitinib|ruxolitinib cream is a topical formulation applied as a thin film to affected areas BID.
15790350|NCT04530344|Drug|Vehicle|Vehicle cream is a topical formulation applied as a thin film to affected areas.
15790351|NCT04530331|Behavioral|Nutrition education|Dietitians visited the worksites of the intervention group once a week to deliver a nutrition education session and provide dietary advice for each participant.
15790352|NCT04530318|Other|Autologous peripheral blood differentiated adult tolerogenic dendritic cells expanded|The infusion of the cells / placebo will take place at the Hospital Clínic de Barcelona (weeks 0, 2 and 4).
15790353|NCT04530318|Other|Placebo|The infusion of the cells / placebo will take place at the Hospital Clínic de Barcelona (weeks 0, 2 and 4).
15790432|NCT04529642|Diagnostic Test|Inertial Measurement Unit evaluation|An IMU was worn by the subjects during the execution of the 6MWT, to assess the kinematic parameters of gait.
15790354|NCT04530305|Drug|Tofacitinib 5 MG [Xeljanz]|Patients with RA for who the introduction of tofacitinib has been decided will be proposed the study. If they accept, they will be followed for 6 months with 3 visits (baseline, 3 and 6 months) which is the usual standard care. In addition to routine markers, stool and blood will be collected at baseline and 3 months specifically for the study.
15790355|NCT04530292|Behavioral|Intervention by a pediatric nurse at the child's home|"The intervention will consist of a coordinated intervention by a pediatric nurse at the child's home to support the parents in the implementation of the theoretical knowledge acquired at the hospital.
~Three home visits will be set up by a nurse during the first six months of the discovery of diabetes in the child. These visits will be organized during the first, fourth and sixth months after the discovery of diabetes and last about 2 hours each time. An additional visit may be set up according to the needs of families."
15790356|NCT04530279|Procedure|Clinical assessment|Clinical assessment of burn depth and the percentage of total body surface area (TBSA) burnt with any method
15790357|NCT04530266|Diagnostic Test|Six minute walk test|Assessment of walking related performance fatigability using six minute walk test
15790358|NCT04530240|Procedure|Liver Transplantation|Use prospectively collected databases from each participate centre, register MELD score recorded at the time of drop-out, liver transplantation and end of the follow-up.
15790359|NCT04530227|Drug|Biological: Camrelizumab|PD-1
15790360|NCT04530227|Drug|Pemetrexed|chemotherapy
15790361|NCT04530227|Drug|Nab-paclitaxel|chemotherapy
15790362|NCT04530214|Other|Blood collection|Blood collection at enrollment (before surgery) and at Visit 1 (45-60 days following surgery)
15790363|NCT04530214|Other|Saliva collection|Saliva collection at enrollment (before surgery) and at Visit 1 (45-60 days following surgery)
15790364|NCT04530214|Other|Electrocardiography (ECG)|Electrocardiography (ECG) at enrollment (24-72h following surgery) and at Visit 1 (45-60 days following surgery) to assess heart rate variability
15790365|NCT04530214|Behavioral|Questionnaires|Mental health assessment through questionnaires at enrollment (24-72h following surgery), at Visit 1 (45-60 days following surgery), at Visit 2 (7 months following surgery) and at Visit 3 (12 months following surgery)
15790366|NCT04530201|Device|Colli-Pee Small Volumes (10 mL) device|Women will self-collect two first-void urine samples at home the day prior to colposcopy using the new generation Colli-Pee Small Volumes (10 mL) device (Novosanis, Belgium). The collector tube will be prefilled with a non-toxic nucleic acid preservative including an internal process control.
15790367|NCT04530188|Drug|Sevoflurane|Inhaled sedation with sevoflurane using the Anesthesia Conserving Device (AnaConDa-S, Sedana Medical, Danderyd, Sweden)
15790368|NCT04530188|Drug|Propofol|Intravenous sedation with propofol, as already used in our ICU
15790369|NCT04530175|Other|blood sampling|2 blood samples will be taken from the blood circuit 1 hour after the start of the hemodialysis session by the nurse in charge of the patient.
15790374|NCT04530136|Drug|Ruconest|Patients will be randomized to Ruconest or Standard of Care
15790375|NCT04530123|Drug|Placebo|TAK-101 placebo-matching intravenous infusion
15790376|NCT04530123|Drug|TAK-101|TAK 101 intravenous infusion
15790377|NCT04530123|Dietary Supplement|Gluten|Powder form (vital wheat gluten)
15790379|NCT04530097|Procedure|RFA|Radiofrequency ablation was performed immediately after enrollment, and melatonin treatment was given for 6 months after 1 week after radiofrequency.
15790380|NCT04530084|Device|OMNI Surgical System|Scheduled for canaloplasty and trabeculotomy with or without cataract extraction
15790381|NCT04530071|Biological|CordSTEM-DD (0.7 x 10^7 cells)|CordSTEM-DD (0.7 x 10^7 cells) on Stage 1
15790382|NCT04530071|Biological|CordSTEM-DD (2.1 x 10^7 cells)|CordSTEM-DD (2.1 x 10^7 cells) on Stage 1
15790383|NCT04530058|Drug|Metformin|Metformin 500 mg twice a day, administered orally or via gastric tube.
15790384|NCT04530058|Drug|Placebos|Placebo twice a day, administered orally or via gastric tube.
15790385|NCT04530045|Other|dosage of concentration of piperacillin and cefepim|Dosage of total plasma concentration of piperacillin and cefepim at different timepoints
15790386|NCT04530032|Other|ketogenic diet|short term (18 day) ketogenic/modified atkins diet use
15790387|NCT04530032|Other|Standard diet|standard (normal) diet use
15790388|NCT04530006|Diagnostic Test|Amantadine Hydrochloride|"Patients who are eligible for the study will be administered a regular 200 mg dose of FDA approved drug amantadine. This will be done at the following timepoints:
~Within 4 weeks of the start of treatment; but as close to commencement of treatment (Day 1 of radiotherapy) as possible for newly diagnosed patients.
~Cycle 1, Day 1 of chemotherapy (temozolomide or lomustine) +/- 7 days
~Day 1 +/- 7 days for each visit where MRI is obtained (typically every 8-12 weeks - pre-cycles 4, 7, 10, for temozolomide or pre-cycles 3, 5, and 7 for lomustine)"
15790389|NCT04529993|Procedure|Bronchoscopy|Multiple level sampling of the respiratory mucosa (cytology brush and biopsies forceps)
15790392|NCT04529967|Other|no interventions|it is a observational study, do not have interventions.
15790393|NCT04529954|Drug|Valproic Acid delivered to ICV|Valproic Acid delivered to ICV via an implantable pump and catheter system
15790394|NCT04529941|Device|Device Implant with Active Treatment|ScNS at 3.5mA output for 2 weeks
15790396|NCT04529928|Device|Carillon Mitral Contour System|Eligible subjects will be implanted with the Carillon Device, utilizing the Carillon Mitral Contour System. The device is a permanent implant in the coronary sinus/great cardiac vein, designed to cinch the mitral annulus. The implant procedure is minimally invasive, conducted via catheter placement.
15790397|NCT04529915|Diagnostic Test|Exosome sampling|"Centrifugation of blood plasma
~Size exclusion chromatography
~ELISA assay, Western blotting
~Deep-learning analysis"
15790398|NCT04529902|Drug|Tumor Necrosis Factor Inhibitors|TNFi claim is used as the reference group.
15790399|NCT04529902|Drug|Abatacept|Abatacept claim is used as the exposure group.
15790400|NCT04529876|Drug|Tofacitinib|Tofacitinib claim is used as the reference group.
15790401|NCT04529876|Drug|Abatacept|Abatacept claim is used as the exposure group.
15790402|NCT04529863|Drug|Tocilizumab|Tocilizumab claim is used as the reference group.
15790403|NCT04529863|Drug|Abatacept|Abatacept claim is used as the exposure group.
15790404|NCT04529850|Drug|Drug: GC4419|GC4419 60 Minute Infusion
15790405|NCT04529837|Device|Dilapan-S|Use of dilapan-S for induction cervical ripening agent
15790406|NCT04529824|Device|Dexcom G6 Continuous Glucose Monitor (CGM) System|Participants wear a blinded Dexcom G6 CGM and a Fitbit Charge 3 activity tracker for 10 days.
15790407|NCT04529811|Drug|Rifaximin Novel Formulation|Rifaximin Novel Formulation
15790408|NCT04529811|Drug|Placebo|Placebo
15790409|NCT04529785|Procedure|SVC only|Patients allocated to this arm will receive an RF ablation with the isolation of the SVC alone
15790410|NCT04529785|Procedure|SVC isolation with substrate modification and vein of Marshal ethanol infusion|Patients allocated to this arm will receive an RF ablation with the isolation of the SVC, substrate modification and vein of Marshal ethanol infusion
15790418|NCT04529759|Other|Control Infant Formula|Powdered partially hydrolyzed whey (WPH) based formula with an oligosaccharide
15790419|NCT04529759|Other|Experimental Infant Formula|Powdered partially hydrolyzed whey (WPH) based formula with oligosaccharides blend
15790420|NCT04529746|Behavioral|EVERYbody Project|Brief behavioral intervention (4 hours across two meetings)
15790421|NCT04529733|Device|IB10 sphingotest PCT+|Whole blood in EDTA for procalcitonin POC testing on IB10 sphingotest PCT+ device
15790422|NCT04529720|Biological|Biological/Vaccine: Pertagen (aP BioNet)|"Pertagen (aP BioNet) was produced with a recombinant B pertussis strain that was genetically inactivated by the introduction of mutations (Arg9Lys and Glu129Gly) in the ptx operon of the S1 gene. Each 0.5 mL dose of Pertagen (aP BioNet) contained 5 µg PTgen, 5 µg FHA, and 0.3 mg as aluminium cation.
~The study vaccine will be presented in a single-dose prefilled syringe. Each participant will be received one intramuscular injection in the non-dominant deltoid region."
15790423|NCT04529720|Biological|Biological/Vaccine: Boostagen (TdaP BioNet)|"Boostagen (TdaP BioNet) was produced with a recombinant B pertussis strain that was genetically inactivated by the introduction of mutations (Arg9Lys and Glu129Gly) in the ptx operon of the S1 gene. Each 0.5 mL dose of Boostagen (TdaP BioNet) contained 5 µg PTgen, 5 µg FHA, and 0.3 mg as aluminium cation. TdaP dose additional contained at least 7.5 Lf tetanus toxoid and at least 2.0 Lf diphtheria toxoid.
~The study vaccine will be presented in a single-dose prefilled syringe. Each participant will be received one intramuscular injection in the non-dominant deltoid region."
15790424|NCT04529720|Biological|Biological/Vaccine: Adacel|"Comparator vaccine, Adacel (Sanofi-Pasteur, North York, ON, Canada) was produced chemically inactivated pertussis toxin. Each 0.5 mL dose of Adacel (as comparator vaccine) contained 2.5 µg PTchem, 5 µg FHA, 3 µg pertactin, 5 µg fimbriae types 2 and 3, 5.0 Lf tetanus toxoid, 2.0 Lf diphtheria toxoid and 0.33 mg as aluminium cation.
~The study vaccine will be presented in a single-dose prefilled syringe. Each participant will be received one intramuscular injection in the non-dominant deltoid region."
15790425|NCT04529707|Behavioral|Transdiagnostic Behavioral Sleep Intervention|"The Transdiagnostic Sleep and Circadian Intervention for Youth (TranS-CY) uses a comprehensive sleep health framework along with robust evidence for promoting healthy sleep patterns in youth. The TranS-CY incorporates best practices from numerous efficacious behavioral sleep interventions including 1) cognitive behavioral therapy, 2) interpersonal and social rhythm therapy, and 3) behavioral treatment of circadian rhythm sleep-wake disorders. The traditional TranS-CY is clinician-led and provides a robust sleep treatment framework for youth with a wide range of disorders and sleep health concerns. For this study, investigators are using the basic framework of the TranS-CY, but clinicians will train parents to incorporate the intervention into the home for their young child with DMD. Trained clinicians will work with parents to ensure the basic components of the TranS-CY are incorporated into the home-based intervention."
15790426|NCT04529694|Other|Psychotherapy|
15790427|NCT04529681|Device|Stroke Riskometer Application|Mobile phone application uses to measure, monitor and manage, it mainly calculates the stroke risk probability within 5 year and 10 years by providing the absolute risk and relative risk which is compared to the normal healthy people with the same age and gender. Not only that, the application purposes to increase general awareness about stroke and its risk factors, and to improve stroke and heart attack prevention on an individual level.
15790428|NCT04529681|Other|Informational Leaflets|Informational leaflets consist of the stroke-related leaflet, CVDs-related leaflet and the healthy eating behaviors including; disease introduction, what are the risk factors, early symptoms and also the preventive measures. These materials were developed and published by health education and promotion division Ministry of Health, Malaysia in 2013 - 2016. Usually it will be distributed to public during health screening program and also can be found at all healthcare facilities. All materials were in Malay language only.
15790429|NCT04529668|Drug|vitamin D supplementation|vitamin D supplementation
15790430|NCT04529668|Drug|usual therapy for nasal polyposis|steroids ( systemic and local )
15790431|NCT04529655|Device|Capillary Refill Assessment|Device to quantify capillary refill time
15790604|NCT04528147|Behavioral|Yi Jin Jing Tiger Roaring Speech Rehabilitation|A traditional Chinese medicine treatment
15790433|NCT04529629|Other|surgery or drug|pheochromocytoma and adrenocortical carcinoma need surgery and primary aldosteronism need drug according to the genetic results
15790434|NCT04529603|Device|LungBrella marker implantation and VATS partial lobe resection|The enrolled patients will receive a plain chest CT scan,then the data be loaded into JediVision software. The JediVision software can navigate the location of nodule and facilitate the implantation of LungBrella marker in the operating room after general anesthesia,then the patients will receive VATS partial lobe resection .
15790435|NCT04529577|Device|His-bundle pacing|"A standard pacing electrode (Medtronic 4076) will be placed in RV apex (or RV septum as a secondary option) and in the right atrial appendage (if indicated).
~A dedicated His-bundle pacemaker electrode (Medtronic 3830) will be placed in the region of His bundle, using a dedicated introducer sheath (Medtronic C304 or Medtronic C315). His-bundle potentials will be identified and His-bundle capture (non-selective or selective) will be ascertained using an electrophysiology recording system. Device programming will focus on providing physiological atrioventricular delay and safety RV pacing as backup."
15790436|NCT04529551|Other|1601A|A filtered, king size cigarette with a menthol capsule in the filter.
15790437|NCT04529551|Other|1601B|A filtered, king size cigarette with a menthol capsule in the filter.
15790438|NCT04529538|Biological|Novel Oral Polio Vaccine Type 1 (nOPV1)|Each 0.1 mL (2 drops) dose of vaccine contains approximately 10^6.5 CCID50.
15790439|NCT04529538|Biological|Novel Oral Polio Vaccine Type 3 (nOPV3)|Each 0.1 mL (2 drops) dose of vaccine contains approximately 10^6.5 CCID50.
15790440|NCT04529538|Biological|Sabin Monovalent Oral Polio Vaccine Type 1 (mOPV1)|The Sabin mOPV1 control vaccine contains ≥ 10^6.0 CCID50 per 0.1 mL (2 drops) dose.
15790441|NCT04529538|Biological|Sabin Monovalent Oral Polio Vaccine Type 3 (mOPV3)|the Sabin mOPV3 control vaccine contains ≥ 10^5.8 CCID50 per 0.1 mL (2 drops) dose.
15790442|NCT04529525|Drug|Ivermectin|Patients will receive the tablet from the branch to which they were randomized only at the time of inclusion and 24 hours after the first dose.
15790443|NCT04529525|Drug|Placebo|Patients will receive the tablet from the branch to which they were randomized only at the time of inclusion and 24 hours after the first dose.
15790444|NCT04529512|Drug|DEXTENZA®|DEXTENZA® is a corticosteroid implant indicated for the treatment of ocular pain following ophthalmic surgery. DEXTENZA® is inserted into the lower lacrimal punctum into the canaliculus by the physician following ophthalmic surgery. A single DEXTENZA® releases a 0.4 mg dose of dexamethasone for up to 30 days following insertion. DEXTENZA® is preservative free, resorbable and does not require removal. Saline irrigation or manual expression can be performed to remove the insert, if necessary.
15790445|NCT04529499|Drug|AVIGAN|Patients will be randomized to the favipiravir + supportive care group in a 1:1 ratio
15790446|NCT04529499|Drug|Placebo Comparator|Patients will be randomized to the placebo + supportive care group in a 1:1 ratio
15790447|NCT04529486|Other|Kinesio taping|Before applying the tape, it was checked whether the children were allergic. Tape was first started from the distal part of the fingers and taped with 0% tension with Kinesio Taping Functional Correction Technique. Another I tape was applied from palmar area of the hand to spina scapula for supination of the forearm and external rotation of the shoulder with %0 tension to make functional correction (Figure 2). Kinesio Taping Functional Correction method is suggested to be done with 75% of tension but for children, we applied it with 0% tension to minimize the shear effects to the skin4. Kinesio Tex Light Touch Plus tape was used for taping application (Kinesio Co., USA).
15790448|NCT04529473|Dietary Supplement|Eubacterium hallii|Eubacterium hallii, ≥ 1x10^9 live bacterial cells (per capsule)
15790449|NCT04529473|Other|Placebo|Placebo capsules are identical to the active treatment
15790450|NCT04529460|Diagnostic Test|COVID-19 antibody point of care test kit|A disponible point of care test that identifies the presence of antibodies to COVID-19
15790451|NCT04529447|Other|Survey|The patient satisfaction survey consisted of 8 items, including 7 Likert scale questions and 1 multiple choice question.
15790452|NCT04529434|Other|Star Homes|110 identical novel-designed houses, known as Star Homes, include the critical structural components e.g. building orientated to provide optimal shading throughout the day, light-weight & durable roof, facade and openings screened from insects to reduce insect entry while assuring airflow, an outdoor fly-proof latrine, and solar power providing electric light at night etc.
15790453|NCT04529434|Other|Traditional African houses|A traditional mud house: with wattle and daub walls, a thatched roof, and no electricity or piped water supply.
15790454|NCT04529421|Behavioral|Online instruction|For some courses and groups of students, instruction is primarily offered digitally, so that the students can participate from outside campus.
15790455|NCT04529421|Behavioral|In-person instruction|For some courses and groups of students, instruction is primarily offered in-person, on campus (or elsewhere).
15790456|NCT04529408|Device|EarSats Pulse Oximeter Probe|Off-the-shelf pulse oximeter embedded into a memory foam ear plug for measuring blood oxygen saturation (SpO2) from the ear canal; in-ear SpO2 measured at-rest and during 6 minute walk test
15790457|NCT04529395|Other|Blending of essential oils|The mixture of essential oils will be applied to the arch of the foot by massage every 8 hours (3 times a day, 6 drops per application with 3 drops per foot).
15790458|NCT04529395|Other|Apricot vegetable oil|The apricot vegetable oil will be applied to the arch of the foot by massage every 8 hours (3 times a day, 6 drops per application with 3 drops per foot).
15790459|NCT04529382|Diagnostic Test|Cognitive testing (Bayley III, WPPSI III and WISC V)|Parents and children will be invited to come for an outpatient clinic visit where cognitive testing and neurologic examination will be performed. In addition to this parents will be asked to fill in questionnaires, provide latest school results and medical files will be requested from treating physicians.
15790460|NCT04529369|Procedure|Middle lobe only Photoselective vaporization of the prostate (PVP)|Middle lobe only Photoselective vaporization of the prostate (PVP) without vaporization of the lateral lobes
15790461|NCT04529369|Procedure|Complete PVP|Traditional Photoselective vaporization of the prostate PVP
15790462|NCT04529356|Device|Transcranial magnetic stimulation|By using different frequency of TMS, the device can generate different effects. For low frequency, such as 1HZ, it mainly generates inhibition on the brain cortex; while high frequency (usually higher than 10HZ) can generate stimulation effects. The later one could be used to treat different central nervous disease.
15790463|NCT04529356|Drug|Acetaminophen|Acetaminophen is used as the painkiller to alleviate patients' headache before and during the clinical trial. In order to decrease the medication bias, we required these patients to only use acetaminophen instead of other non-steroid anti-inflammatory drugs. In the meantime, participants are requested to recorder the frequency and dosage of acetaminophen they used during the treatment course.
15790464|NCT04529343|Other|Virtual reality mediated upper extremity rehabilitation|"Game-based exercise will be applied for different range of motion of the upper extremity. Gamified exercise program consisting of 4 different scenarios will be applied 3 days a week for 6 weeks to the patients in the virtual reality group. A session takes an average of 45 minutes.
~Games to be applied;
~Finger flexion-extension (10 minutes / session)
~Wrist flexion, extension, ulnar and radial deviation (10 minutes / session)
~Forearm pronation and supination (10 minutes / session)
~Elbow flexion-extension-shoulder internal and external rotation (15 minutes / session) will have scenarios controlled with. All patients participating in the study will receive exercise therapy in the form of upper extremity stretching, range of motion, and fine skill training 2 days a week for 6 weeks. Each session takes an average of 45 minutes."
15790465|NCT04529343|Other|Classical exercise therapy for upper extremities|All patients participating in the study will receive exercise therapy in the form of upper extremity stretching, range of motion, and fine skill training 2 days a week for 6 weeks. Each session takes an average of 45 minutes.
15790466|NCT04529330|Procedure|fasciotomy|if it was suspected with ACS, the fasciotomy was conducted. but if the blister observed, it means decreased conmpartment sydrome. therefore, the blister observed can avoid unnecessary fasciotomy to patients suspected with ACS
15790467|NCT04529317|Dietary Supplement|Quinoa and quinoa-based food|"Products created replaced grains, legumes, tubers, also farinaceous commonly consumed by the participants and only the cereal fraction was modified, similar products based on quinoa flour were created.
~Thus, apart from delivering quinoa, quinoa flakes and quinoa flour to the participants, they were given products created with ≥70% quinoa flour and were biscuits, crackers, brioche, sponge cake, baguette bread, sliced bread and pasta. Moreover, a quinoa-based recipe was delivered with eight commonly consumed recipes that replaced the tuber, legume or grain of the recipe. Each subject received the equivalent of what they consumed according to their regular diet dietary records."
15790468|NCT04529304|Device|Bilateral Bispectral Index and EEG|"raw-EEG and spectrographic EEG-visualization based on the Medtronic Device Bilateral BiSpectral Index"
15790469|NCT04529291|Other|Group with walking disorder|During the patient's hospitalization, two questionnaires will be completed, assessing the handicap of the patient in his daily activities, and the specific incapacity to carry out activities of daily living and social life (10 minutes to complete). The patient will then carry out two 20-meter round-trip walking tests during his first day and his last day of care at the hospital. Additional home visits, corresponding to intervention, performed by a member of the investigative team, will take place once a week (15-20 minutes). The team will collect his feelings about the evolution of symptoms through the two questionnaires, and quantify the evolution of his walking. Walk tests are recorded using small inertial sensors (accelerometers and gyrometers) that will be placed at his feet, belt and forehead. This examination is not painful. All the measurements are carried out in 15 minutes by a member of the team.
15790470|NCT04529291|Other|Group without walking disorder|"During the patient's hospitalization, two questionnaires will be completed, assessing the handicap of the patient in his daily activities, and the specific incapacity to carry out activities of daily living and social life (10 minutes to complete). The patient will then carry out two 20-meter round-trip walking tests during his first day and his last day of care at the hospital.
~Additional home visits, corresponding to interventions, performed by a member of the investigative team, will take place once a week (15-20 minutes). The team will collect his feelings about the evolution of symptoms through the two questionnaires, and quantify the evolution of his walking. Walk tests are recorded using small inertial sensors (accelerometers and gyrometers) that will be placed at his feet, belt and forehead. This examination is not painful. All the measurements are carried out in 15 minutes by a member of the team."
15790471|NCT04529278|Drug|Liraglutide|"Liraglutide is initiated at 0.6 mg / day during week S1 (initiation D1) during weekly hospitalization in the diabetology department. Then the dose of liraglutide is increased to 1.2 mg / day on week S2 (increase in dose on D8) then to 1.8 mg / day on week S3 (increase in dose on D15).
~The daily dose is then 1.8 mg until week W26."
15790472|NCT04529265|Drug|Methylene Blue|Multiple dosages of 2mg/kg MB from the day of surgery to postoperative 2 days
15790473|NCT04529265|Drug|Placebo|Multiple dosages of normal saline from the day of surgery to postoperative 2 days
15790474|NCT04529252|Other|Specimen collection|Blood, urine, stool, cerebrospinal fluid, and skin biopsy may be collected
15790475|NCT04529239|Device|Abbott Freestyle Libre Pro|Continuous glucose monitoring device to analyze diabetes biomarkers.
15790476|NCT04529226|Drug|Clozapine|Start treatment with 12.5 mg every 12 hours with the recommendation to increase dosage by 25-50 mg/day provided it is well tolerated up to a level of 300-450 mg/day at the end of the second week
15790477|NCT04529226|Drug|haloperidol, pimozide, olanzapine, risperidone, amisulpride|Treatment as usual using first-generation or second-generation antipsychotics
15790478|NCT04529213|Procedure|Rapid Maxillary Expansion Treatment|The patients were treated with KBME, Hyrax and MIDME maxillary expansion appliances, respectively. All expansion appliances containing a Hyrax expansion screw positioned parallel to the second premolars and were used to correct the posterior crossbite. In the MIDME group, two mini-screws with a diameter of 1.6 mm and a length of 10 mm are located on the right and left sides between the roots of the 2nd premolar and 1st molar teeth with 60-70° angle. KBME and Hyrax expansion appliances were cemented with glass ionomer cement and MIDME was cemented with using the light-cured composite. Same protocol was applied to all patients during RME treatment. Expansion screws in all groups were activated by two turns a day.
15790479|NCT04529200|Other|electrotherapy treatment|physical therapy management like EMS IFT
15790480|NCT04529187|Drug|Midazolam|To monitor the changes in heart function induced after midazolam sedation using cardiac MRI.
15790481|NCT04529187|Drug|Dexmedetomidine|To monitor the changes in heart function induced after dexmedetomidine sedation using cardiac MRI.
15790505|NCT04528966|Other|Whole-Body Vibration|Whole-Body Vibration Treatment for 3 sessions in a week for 8 weeks. Each sessions takes 15 minutes.
15790506|NCT04528966|Other|Conventional Physiotherapy|conventional physiotherapy for 2 sessions in a week for 8 weeks. Each sessions takes 45 minutes.
15790482|NCT04529174|Dietary Supplement|CardioLux™HDL|"Enrollment will occur according to the inclusion/ exclusion criteria and after the review and signing of the Informed Consent form. Clinical testing will be performed at baseline and each visit (2, 3).
~Measurement of height, weight with body composition analysis, body mass index, waist circumference, and vital signs (blood pressure, heart rate) will be measured.
~Review of medical history and current medications by clinician; and collection of fasting blood for testing of the complete blood count (CBC), comprehensive metabolic profile (CMP), as well as a urine pregnancy test in females of child-bearing potential.
~Visits: Baseline (Visit 1), Week 6 (Visit 2) and Week 12 (Visit 3/End of Study)"
15790483|NCT04529174|Dietary Supplement|Placebo|"Enrollment will occur according to inclusion /exclusion criteria and after the review and signing of the Informed Consent form. Clinical testing will be performed at baseline and each visit (2, 3).
~Measurement of height, weight with body composition analysis, body mass index, waist circumference, and vital signs (blood pressure, heart rate) will be measured.
~Review of medical history and current medications by clinician; and collection of fasting blood for testing of the complete blood count (CBC), comprehensive metabolic profile (CMP), as well as a urine pregnancy test in females of child-bearing potential.
~Visits: Baseline (Visit 1), Week 6 (Visit 2) and Week 12 (Visit 3/End of Study)"
15790484|NCT04529161|Dietary Supplement|Fasting Mimicking Diet (FMD)|The treatment consists in the self-administration of FMD at home - closely followed by the neuropsychologist by phone and by a properly trained nutritionist in the FMD sector - for 5 days a month for 6 consecutive months.
15790485|NCT04529161|Dietary Supplement|Routinary diet habits|Subjects will follow their routinary eating habits for 6 consecutive months
15790486|NCT04529148|Drug|Ginkgo biloba dropping pills，best western medicine treatment|oral
15790487|NCT04529148|Drug|Mimetic drug of ginkgo biloba dropping pills，best western medicine treatment|oral
15790488|NCT04529135|Drug|Dexmedetomidine|The prepared drug marks the assigned group as unknown. In both groups, the test drug marked as unknown begins to be administered in an anesthetic induction. When the patient arrives in the operating room, electrocardiogram, noninvasive blood pressure, and bispectral index (BIS) monitoring is performed. In both groups, 2 mg/kg of propofol induces general anesthesia, intubates after administration of rocuronium 0.6 mg/kg, and maintains anesthesia with sevoflurane 1.5-2.5 vol%. Use 0.075 mg of palonosetrone as an antiemetics after inducing anesthesia. Adjust the inhalation anesthetic to maintain BIS 40-60 , mechanical ventilation to maintain the Tidal volume of 8 ml/kg, PEEP 5 mmHg and end-tidal carbon dioxide (EtCO2) of 35-40 mmHg. Push 1mcg of fentanyl and 1g of acetaminophen per kg for pain control 20 minutes before the end of surgery.
15790489|NCT04529135|Drug|Remifentanil|The prepared drug marks the assigned group as unknown. In both groups, the test drug marked as unknown begins to be administered in an anesthetic induction. When the patient arrives in the operating room, electrocardiogram, noninvasive blood pressure, and bispectral index (BIS) monitoring is performed. In both groups, 2 mg/kg of propofol induces general anesthesia, intubates after administration of rocuronium 0.6 mg/kg, and maintains anesthesia with sevoflurane 1.5-2.5 vol%. Use 0.075 mg of palonosetrone as an antiemetics after inducing anesthesia. Adjust the inhalation anesthetic to maintain BIS 40-60 , mechanical ventilation to maintain the Tidal volume of 8 ml/kg, PEEP 5 mmHg and end-tidal carbon dioxide (EtCO2) of 35-40 mmHg. Push 1mcg of fentanyl and 1g of acetaminophen per kg for pain control 20 minutes before the end of surgery.
15790490|NCT04529096|Drug|LY3016859|Administered IV
15790491|NCT04529096|Drug|Placebo|Administered IV
15790492|NCT04529083|Device|Mr. MAPP|Mixed reality device to provide virtual mirror therapy to patients with phantom pain
15790493|NCT04529070|Behavioral|Nightmare Rescripting and Rehearsal|This study aims to test the efficacy of an abbreviated version of Imagery Rehearsal Therapy ('Nightmare Rescripting and Rehearsal Therapy' (NRRT)) administered by non-mental health professionals in a Primary Care setting.
15790494|NCT04529070|Behavioral|standard of care|standard of care
15790495|NCT04529057|Procedure|Rapid Maxillary Expansion Treatment|The patients were treated with KBME, Hyrax and MIDME maxillary expansion appliances, respectively. All expansion appliances containing a Hyrax expansion screw positioned parallel to the second premolars and were used to correct the posterior crossbite. In the MIDME group, two mini-screws with a diameter of 1.6 mm and a length of 10 mm are located on the right and left sides between the roots of the 2nd premolar and 1st molar teeth with 60-70° angle. KBME and Hyrax expansion appliances were cemented with glass ionomer cement and MIDME was cemented with using the light-cured composite. Same protocol was applied to all patients during RME treatment. Expansion screws in all groups were activated by two turns a day.
15790496|NCT04529044|Drug|Lutetium Lu 177 Dotatate|Given IV
15790497|NCT04529031|Behavioral|Reminder Focused Positive Psychiatry|The focus of RFPP is on enhancing contextual discrimination and emotional regulation, and promoting the use of adaptive coping strategies in response to trauma reminders, including recognizing reminders, shifting attention from intrusive memories during exposure to reminders to a focus on positive feelings, thoughts, goals, and choices
15790498|NCT04529031|Behavioral|attentional control condition (group process)|This group process will undergo telehealth relaxation therapy twice a week for 6-week. Subjects will receive progressive muscle relaxation and other relaxation techniques as well as education about PTSD and supportive psychotherapy
15790499|NCT04529018|Combination Product|[18F]CETO|[18F]CETO is a PET radiotracer used to diagnose and visualise the cause(s) of primary aldosteronism
15790500|NCT04529005|Drug|Angiotensin II|If intraoperative or postoperative hypotension occurs (e.g. SBP < 120 mmHg) and the attending surgeon and/or attending anesthesiologist deems vasopressor therapy to be necessary, angiotensin II (Giapreza) will be the first vasopressor used for management.
15790501|NCT04528992|Other|Blood Flow Restriction Therapy|BFR is a rehabilitation method that involves wearing a tight band around the exercising extremity to briefly limit blood flow while doing light weight exercises. The response is similar to heavy weight training or lifting but without the stress on the extremity that is still healing from surgery. Will be given after 2 weeks standard postoperative physical therapy per surgeon's ACL reconstruction protocol following surgery.
15790502|NCT04528992|Other|Standard Postoperative Physical Therapy|This is the surgeon's standard postoperative physical therapy protocol after ACL reconstruction.
15790503|NCT04528979|Other|BioRoot RCS® root canal sealer|Root canal obturation with guttapercha and BioRoot RCS® root canal sealer
15790504|NCT04528979|Other|AH Plus® root canal sealer|Root canal obturation with guttapercha and AH Plus® root canal sealer
15790507|NCT04528953|Behavioral|Interval walking and Qigong exercise|"Interval walking: The subjects will be asked to complete daily 30 minutes of walking in two 15-minute bouts with the rest interval for at least 0.5 an hour and not more than 2 hours between each bout.
~Qigong exercise: mind-body exercise using the six healing sound Qigong exercise will be used because it is easy to learn, requires minimal physical capability, and can be performed even in a sitting body position."
15790508|NCT04528940|Diagnostic Test|PD-1/PDL-1 staining|Every endometrial or ovarian carcinoma will be stained for PD-1/PDL-1. The stage and grade of the tumor will be determined and correlation between tumor grade and stage and PD-1/PDL-1 staining will be made.
15790509|NCT04528927|Drug|HCQ|600 mg on the 1st day as a starting dose then 200 mg * 2 /D for 9 days
15790510|NCT04528927|Drug|Azithromycin|500 mg (1st day) then 250 mg / D for 4 days
15790511|NCT04528927|Drug|Doxycycline|200 mg per day for 10 days
15790512|NCT04528927|Dietary Supplement|Zinc|220 mg per day for 10 days
15790513|NCT04528914|Other|Low-FODMAP diet|The low-FODMAP diet will contain the amount of FODMAPs that will not exceed the cut-offs for each FODMAP sugar per serving of food per sitting. Diets will be individually tailored by dietitian and delivered by a catering company (five meals each day).
15790514|NCT04528888|Drug|Enoxaparin|Enoxaparin will be administered subcutaneously at standard prophylactic dose (i.e., 4000 UI once day, increased to 6000 UI once day for patients weighting more than 90 kg). The treatment will be administered daily up to ICU discharge. After ICU discharge it may be continued or interrupted in the destination ward up to clinical judgement of the attending physician.
15790515|NCT04528888|Drug|Methylprednisolone|Methylprednisolone will be administered intravenously with an initial bolus of 0,5 mg/kg followed by administration of 0,5 mg/kg 4 times daily for 7 days, 0,5 mg/kg 3 times daily from day 8 to day 10, 0,5 mg/kg 2 times daily at days 11 and 12 and 0,5 mg/kg once daily at days 13 and 14.
15790516|NCT04528888|Drug|unfractionated heparin|Patients in this group will receive unfractionated heparin and methylprednisolone. Unfractionated heparin will be administered intravenously at therapeutic doses. The infusion will be started at an infusion rate of 18 IU/kg/hour and then modified to attain APTT Ratio in the range 1.5-2.0. aPTT will be periodically checked at intervals no longer than 12 hours. The treatment with unfractionated heparin will be administered up to ICU discharge. After ICU discharge anticoagulant therapy may be interrupted or switched to prophylaxis with LMWH in the destination ward up to clinical judgement of the attending physician.
15790517|NCT04528875|Device|Ultrasound imaging|Imaging of low back with ultrasound
15790518|NCT04528862|Behavioral|Nature slides|participants will view a presentation of nature slides
15790519|NCT04528862|Behavioral|Urban slides|participants will view a presentation of urban slides
15790520|NCT04528849|Drug|Gonadotropin dose increment timing|Gonadotropin dose increments of 25 IU will be utilized on 7th and 14th day of ovulation induction for each study group.
15790521|NCT04528836|Drug|BBP-398 (Formerly Known as IACS-15509)|oral capsules
15790522|NCT04528823|Other|Strategy 2: Symptom screen, Genexpert and TST|Participants follow an algorithm similar to the standard care, however participants with positive symptom screen and/or positive TST will receive GX (i.e., GX replaces CXR in standard care algorithm). GX positive are considered to have active TB. TST positive and GX negative receive LTBI treatment. If an individual is not able to provide sputum, they will undergo a CXR.
15790523|NCT04528823|Other|Strategy 3:Symptom screen, CXR but NO TST|Participants will receive symptom screening and CXR. No TST will be performed. If CXR abnormal or symptom positive, they undergo microbiological investigation. If the CXR is normal, and/or microbiological investigations negative - they receive LTBI treatment as per national guidelines. If microbiological investigation is positive they will be offered treatment for active TB.
15790524|NCT04528810|Other|not applicable (Observational Study)|This is an observational study and does not include interventions.
15790525|NCT04528797|Drug|Levothyroxine|
15790526|NCT04528797|Drug|Methylprednisolone|
15790527|NCT04528784|Device|Transcutaneous tibial nerve stimulation|Transcutaneous tibial nerve stimulation is a non-invasive electrical stimulation of the posterior tibial nerve, a branch of the sciatic nerve via sacral plexus. In our study the tibial nerve will be stimulated using Transcutaneous Electrical Nerve Stimulation (TENS) unit with two surface adhesive electrodes. The anode will be positioned between 5-10 cm above medial malleolus and posterior to the edge of the tibia and the cathode will be positioned distally on arch of the foot .
15790530|NCT04528758|Drug|Rhodamine 6G|Rhodamine 6G radio-pharmaceutical will be injected to determine myocardial blood flow
15790531|NCT04528745|Diagnostic Test|Bio Impedance Spectroscopy (BIS)|Determination of fat free mass by BIS
15790532|NCT04528732|Behavioral|Group Cognitive Behavioral Therapy (G-CBT)|G-CBT consists of 10-session for HIV/AIDS-associated stigma, utilizing core components of CBT, including psychoeducation, cognitive restructuring, and skill-building to increase adaptive coping mechanisms.
15790533|NCT04528732|Behavioral|Multiple Family Group (MFG)|MFG consists of 10-sessions that strengthen family relationships intended to address HIV/AIDS-associated stigma at the individual level and within families. The core components of MFG are known as 4Rs and 2S's: rules, responsibility, relationships, respectful communication, stress and social support.
15790534|NCT04528719|Biological|mRNA-1345|Formulation for injection
15790535|NCT04528719|Drug|Placebo|0.9% sodium chloride (normal saline) injection
15790536|NCT04528706|Drug|MIN-102|Once-daily dosing with a volume specified by the pharmacokineteic specialist to achive the desired plasma exposure. Min-102 Oral suspension, strength 15mg/ml.
15790605|NCT04528147|Behavioral|Conventional Speech Rehabilitation|A active speech rehabilitation method recommended by the Parkinson's Foundation of America
15790537|NCT04528693|Behavioral|Circuit training (combination of strength and endurance exercises)|The intervention will last 3 months, exercises will take place 3 times a week and will consist of strength exercises, interspersed with bouts of endurance exercise carried out on circuit machines integrated with the Milon computer software for a total of 30 minutes per session.
15790538|NCT04528680|Device|Sonication for opening of blood-brain barrier|Implantation of SC-9 device and repeat activation of 9 ultrasound emitters during i.v. injection of microbubbles
15790539|NCT04528680|Drug|Chemotherapy, albumin-bound paclitaxel|Intravenous infusion of ABX over 30 minutes
15790540|NCT04528667|Drug|STI-5656|STI-5656 (abivertinib maleate) is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor.
15790541|NCT04528667|Drug|Placebo|Placebo capsules
15790542|NCT04528654|Other|Mobile Health Application|The participants will be given instructions to use their smartphone or tablet to download the hypertension tracking app. They will follow the instructions provided within the app and use it to track their blood pressure over the next six months.
15790543|NCT04528641|Biological|GRAd-COV2|Single intramuscular administration.
15790544|NCT04528628|Drug|SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors)|Patients will be treated with one kind of selective serotonin reuptake inhibitors/ serotonin and norepinephrine reuptake inhibitors. Dose is titrated to the minimum effective dose within 2 weeks. Benzodiazepines can be used for a short period lasting no more than 2 weeks.
15790545|NCT04528628|Drug|Treatment as Usual|The research doctor discusses the treatment plan with the patient, and therapies and drugs are not limited.
15790546|NCT04528628|Combination Product|SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors) Combined with Magnetic Stimulations|Drug therapies are the same as the SSRIs/SNRIs monotherapy group. Patients will randomly receive one kind of magnetic stimulations including repetitive transcranial magnetic stimulation (rTMS), continuous theta burst stimulation(cTBS) and intermittent theta burst stimulation (iTBS) at a ratio of 1:1:1.
15790547|NCT04528615|Behavioral|CCK In-Person Sessions|This group attended eight weeks of nutrition education-focused experiential learning.
15790548|NCT04528615|Behavioral|CCK Printed Materials|This group did not attend any in-person sessions and was only provided with select CCK written materials.
15790549|NCT04528602|Procedure|Control (Extended leg position) Group|"Common procedure steps -Legal representatives of the infants will sign an informed consent form. Materials (soap, napkin, non-sterile gloves, diaper, wet cotton towels for newborns, waste container, diaper change mat) will be prepared.
~Hands will be washed and gloves will be worn. Tapes of the infant's dirty diaper will be opened.
~For the Control Group
~-The infant will be grasped on the legs, the legs will be given extension position and lifted up.
~The dirty diaper will be folded in two and the perineum area will be wiped with a wet cotton towel from the front to the back.
~The infant's feet will be freed. The dirty diaper will be removed and thrown into the general waste bin. The used gloves will be removed.
~The infant's legs will be given in extension position and a clean diaper will be placed under them.
~Tapes of the clean diaper will be fastened. Hands will be washed after the procedure Data will be collected before, during, after and 3 minutes after application."
15790550|NCT04528602|Procedure|Experimental (Legs are flexed toward abdomen) Group|"Procedure steps for the Experimental Group
~Common procedure steps
~The infant will be grasped on the legs; the legs will be kept in the flexion position and approached toward the abdomen.
~The dirty diaper will be folded in two and the perineum area will be wiped with a wet cotton towel from the front to the back.
~The infant's feet will be freed.
~The dirty diaper will be removed and thrown into the general waste bin. The used gloves will be removed and thrown into the medical waste bin.
~The infant's legs will be kept in the flexion position and a clean diaper will be placed under them. A bottom care plan will be applied in line with the treatment plan, if necessary.
~Tapes of the clean diaper will be fastened.
~Hands will be washed after the procedure.
~Data will be collected immediately before, during, immediately after and 3 minutes after the end of application."
15790551|NCT04528589|Other|prenatal psychotherapy|Prenatal psychotherapy to break intergenerational risk of adverse childhood events
15790552|NCT04528576|Device|Dragonfly mitral valve repair system|With transesophageal echocardiographic guidance,implanting clip using Dragonfly mitral valve repair system
15790553|NCT04528563|Drug|Ketorolac Tromethamine 10 MG/ML|Non-Steroidal-Anti-Inflammatory given intravenously.
15790554|NCT04528563|Drug|Morphine Sulfate 10Mg/1mL Injection|Opioid commonly used for acute abdominal pain given intravenously.
15790555|NCT04528550|Biological|Autologous bone marrow-derived mononuclear cells|Intrathecal transplantation of autologous bone marrow-derived mononuclear cells through lumbar injection.
15790556|NCT04528550|Drug|Placebo|Included patients will receive the same amount of saline through lumbar injection.
15790557|NCT04528537|Other|questionnaire|16-item quality of recovery questionnaire for the postanesthesia care unit (QoR-PACU)
15790558|NCT04528524|Other|Questionnaire|QoR-15Dt
15790559|NCT04528511|Device|Continuous Electronic Monitor|All patients with NOAF complicating AMI will receive at least 5 days electronic monitoring for the evaluation of NOAF burden
15790560|NCT04528498|Other|Preimplantation Genetic Testing|Embryo biopsies will undergo preimplantation genetic testing for aneuploidies as per standard of care, and polygenic disease risk (PGT-P) will be computed for these samples.
15790561|NCT04528485|Other|Sea swimming|8 sessions of swimming activities in the sea
15790562|NCT04528472|Other|Acupuncture Treatment|stimulate acupoints to accelerate recovery
15790563|NCT04528472|Other|Regular Treatment|Oral Medicine and Rehabilitation Treatment
15790564|NCT04528459|Device|Stryker© ADAPT™ platform|The ADAPT system is a software platform that utilizes augmented reality to assist surgeons with implant alignment, lag screw length and positioning, and distal interlocking screw placement for cephalomedullary fixation of peritrochanteric femur fractures.
15790565|NCT04528459|Radiation|Traditional fluoroscopy|For patients in the control group, traditional fluoroscopy will be utilized for placement of the cephalomedullary nail.
15790570|NCT04528433|Behavioral|Medical-education-community Collaborated Intervention|The Medical-education-community Collaborated Intervention adds an additional part in comparison with the control group of classroom management guidance for teachers, review and practice organizational skills based on school daily activities in the school, teacher rewards and encouragement of students.
15790571|NCT04528433|Behavioral|routine clinical care|Routine clinical care includes a structured family behavioral intervention for ADHD symptom management and organizational skill training, the medication will be used if necessary.
15790572|NCT04528420|Other|optimised management|"At the inclusion , the patient will benefit from an early consultation with a nutritionist, a pain doctor and a social worker.
~During the preparation phase for radiotherapy the patient will benefit from weekly consultations with a pain nurse and a dietician.
~During the radiotherapy the patient will be weighed daily and have an assessment of their nutritional needs and a weekly consultation with a pain nurse and dietician and then twice a month until three months post-radiotherapy."
15790573|NCT04528407|Other|Observation without intervention|This study is a follow-up study without intervention.
15790574|NCT04528394|Radiation|Photon|Photon combined with Carbon ion in Arm 1
15790575|NCT04528394|Radiation|Proton|Proton combined with Carbon ion in Arm 2
15790576|NCT04528394|Radiation|Carbon ion|Same dose and fractionation will be used in both arms.
15790577|NCT04528381|Procedure|Laparoscopy|Laparoscopic orchiopexy
15790578|NCT04528368|Biological|Convalescent plasma|The intervention group will receive 400 mL of convalescent plasma with a SARS-CoV-2 antispike antibody titer with a dilution ≥ 1: 320.
15790579|NCT04528355|Drug|data collection|Study subjects will receive alemtuzumab, melphalan, thiotepa, fludarabine and hydroxyurea-based, reduced-intensity conditioning regimen in accordance with clinical practice at UPMC Children's Hospital of Pittsburgh at the discretion of the treating physician. Medical data will be abstracted from subject's medical charts once the patient signs the informed consent.
15790580|NCT04528329|Drug|Early-Dexamethasone|early use of dexamethasone as early as laboratory evidence of high inflammatory markers
15790581|NCT04528329|Drug|Late dexamethazone|Use of dexamethasone on deterioration of the cases with increased severity
15790582|NCT04528316|Behavioral|Pilates Core Stability Exercises program|"Twenty patients will receive Pilates core stability exercises program ONLY. Total Period: 12 Weeks
~Stages: Three stages:
~Stage I: Warm-up: consists of four Pilates motions:
~Breathing:
~Rolling back:
~Coccyx-curl:
~Hundred breathing:
~Stage II: Work-out: consists of twelve Pilates motions:
~Single leg stretch:
~Straight leg raise:
~Basic bridge:
~Bridging variation:
~Quadruped:
~Clap with seal motion
~Mermaid twist:
~Swimming:
~Double leg stretch:
~Shoulder bridge:
~Swan dive:
~Leg full front:
~Stage III: Cool-down: consists of three Pilates motions:
~Rest position:
~Cat with arm/leg extension:
~Breathing:"
15790583|NCT04528316|Behavioral|Balance Program|Total Period: 12 Weeks. The designed HUMAC program will work on the modified clinical test of sensory integration of balance (mCTSIB) with eyes open and with eyes closed, the center of pressure (COP) and the limit of stability test (LOS).
15790584|NCT04528316|Behavioral|Coordination|"Total Period: 12 Weeks. Coordination will be assessed using BOT2, Bilateral coordination (Sub test No.4) composed of 7 items and Upper-Limb coordination (Sub test No.7) composed of 7 items too.
~The raw scores are recorded first then it is converted into point scores, then subtest total point score is obtained by adding point scores."
15790585|NCT04528303|Genetic|Whole genome sequencing|Genomic sequencing and molecular diagnostic results
15790586|NCT04528303|Genetic|Whole exome sequencing|Genomic sequencing and molecular diagnostic results
15790587|NCT04528290|Drug|Ozanimod|Ozanimod capsule formulation of 0.92mg
15790588|NCT04528290|Drug|Ozanimod|Ozanimod, granule formulation of 0.92mg
15790589|NCT04528277|Drug|rifapentine plus isoniazid|receive the 1-month regimen of three times weekly rifapentine (450mg po) plus isoniazid (400mg po)
15790590|NCT04528264|Device|Intraoperative ultrasound guided|Samsung Mysono U6 machine with LN 15 linear (https://www.samsunghealthcare.com/en/products/UltrasoundSystem/MySono%20U6/General%20Imaging/transducers) probe capable of Musculoskeletal imaging will be used for visualization and location of fracture after which elevation and reduction of fracture will be attempted. The ultrasound probe will be used as described by McCann. Radiographic continuity of periosteal shadow without any step will be taken as end point for reduction and the procedure will be terminated.
15790591|NCT04528264|Other|Conventional blind reduction technique|Conventional blind reduction technique
15790592|NCT04528238|Other|Relaxing Visual Immersion|During the intravenous treatment for cancer, a nature movie will be projected on the ceiling of the room, along with natural sounds or a relaxing music. The patient will choose the movie or movies he wants to watch and can decide to stop the Relaxing Visual Immersion (RVI) at any time. The RVI is a system that does not isolate the patient from his familiar or medical entourage and which integrates virtual scenarios in the environment of care.
15790593|NCT04528212|Drug|Glimepiride Tablets|Glimepiride (4 mg) per Day
15790594|NCT04528212|Drug|glimepiride plus fenofibrate|Glimepiride (4 mg) plus Fenofibrate (160 mg) per Day
15790595|NCT04528212|Drug|glimepiride plus curcumin|Glimepiride (4 mg) plus Curcumin (1100 mg) With 5mg Black Pepper per Day
15790596|NCT04528199|Drug|[18F]FLOR (FC303) Injection|Single dose of 10 ±1 millicurie (mCi) of [18F]FLOR (FC303) injection followed by the PET/CT scan.
15790597|NCT04528186|Diagnostic Test|Maternal thyroid volume|Maternal thyroid volume measurement
15790598|NCT04528173|Drug|Ketorolac|Ketorolac (0.5mg/kg; maximum 15mg intravenously) will be given at end of procedure after evaluation for hemostasis.
15790599|NCT04528173|Drug|Dexmedetomidine|Dexmedetomidine (1ug/kg with maximum 50ug intravenously) will be given at beginning of procedure.
15790600|NCT04528173|Drug|Morphine|Morphine (0.05-0.1 mg/kg intravenously) will be given intra-operatively per institutional standard clinical care.
15790601|NCT04528173|Drug|Fentanyl|Fentanyl (0.5-2 ug/kg intravenously) will be given intra-operatively per institutional standard clinical care.
15790602|NCT04528160|Other|Pain neuroscience education and exercise|PNE will be conducted in line with international guidelines and will cover the neurophysiology of pain, transition from acute to chronic pain and the nervous system ability to modulate the pain experience. Exercise will included genera exercise delivered at moderate intensity.
15790603|NCT04528160|Other|Usual Care|Usual care delivered at primary care for older adults with pain.
15790606|NCT04528134|Device|Extended Contact RMGI (Resin-modified Glass Ionomer) Varnish|This is a site-specific, light-cured, durable coating that forms an immediate layer of protection that releases fluoride, calcium and phosphate and can be recharged with fluoride by using fluoride-containing products over the 6-month life of the product.
15790607|NCT04528134|Device|5% Sodium Fluoride Varnish|This is a site-specific 22,600ppm Sodium Fluoride varnish that hardens on the teeth upon contact with saliva.
15790608|NCT04528121|Other|CoDuSe balance training and step square exercises|"The standardized intervention targeted visual, somatosensory, and vestibular aspects of balance and will be included with balance exercises
~Examples of core stability exercises as follows: in supine position with knees bent, slowly slide one heel forward to straighten leg; and, in four-point kneeling position, slide one foot in a straight line away from the body and lift the leg off the floor.
~Examples of dual-task exercises as walking while turning one's head and juggling a balloon.
~Examples of sensory strategies as standing and walking on uneven surfaces and standing with eyes closed."
15790609|NCT04528121|Other|conventional balance training|static and dynamic balance training exercises from sitting, standing and ambulation activities
15790610|NCT04528108|Drug|Kidney-tonifying and tune up Chong-Ren hemostasis Chinese medicine|Participants of Chinese medicine periodic therapy group will be treated with kidney-tonifying and tune up Chong-Ren hemostasis Chinese medicine periodic therapy. During bleeding period, use kidney-tonifying, heat-clearing and consolidating channel for hemostasis Chinese medicine to stop bleeding. The kidney-tonifying hemostasis prescription is made up of Nvzhenzi, Hanliancao, Tusizi, Xianhecao, Cebaiyetan, Danpi, Zhimu, etc. When the bleeding stops, use the kidney-tonifying, essence-strengthening and blood-activating, menstruation-regulating Chinese medicine to regulate menstruation. The kidney-tonifying and menstruation-regulating prescription is made up of Shengshudi, Zhimu, Tusizi, Fupenzi, Bajirou, Danggui, Danpi, etc. The drugs are granules for taking after infusion once a day. Participants receive this treatment for 3 months.
15790611|NCT04528108|Drug|Gong Xue Ning capsules|Participants of Gong Xue Ning capsules group children will be treated with Gong Xue Ning capsules, 2 capsules 3 times a day during the bleeding period. When the bleeding stops, patients will be treated with Zhi Bai Dihuang pills,8 pills 3 times a day. Participants receive this treatment for 3 months.
15790612|NCT04528095|Drug|Clozapine|Clozapine 400 ~ 600mg/d or plasma concentration >350ng/ml Amisulpride 200-800mg/d Gingke biloba 120-360mg/d
15790613|NCT04528095|Device|MECT|MECT:The treatment lasted for 4 months,16 times in total MST:The treatment lasted for 4 months,16 times in total
15790614|NCT04528095|Device|DBS|Two electrode emplacement groups (target nucleus accumbens and hippocampus respectively)
15790617|NCT04528069|Device|ACRYSOF® IQ PanOptix® Toric Trifocal IOL|Single-piece, ultraviolet and blue-light filtering, foldable, multifocal toric IOL intended to provide vision to aphakic subjects at near, intermediate, and distance and to correct pre-existing corneal astigmatism. This device is approved in Australia.
15790618|NCT04528069|Procedure|Cataract surgery|Cataract extraction by phacoemulsification, followed by implantation of the IOL per investigator's standard of care and instructions for use
15790619|NCT04528056|Drug|Sulfasalazine|Sulfasalazine is an anti-inflammatory and immunosuppressive drug
15790620|NCT04528056|Drug|Ambrisentan|Ambrisentan is one of the specific drug therapy for pulmonary arterial hypertension
15790621|NCT04528056|Drug|Sulfasalazine's placebo|Sulfasalazine's placebo is similar to Sulfasalazine in form and dosage
15790622|NCT04528056|Drug|Ambrisentan's placebo|Ambrisentan's placebo is similar to Ambrisentan in form and dosage
15790623|NCT04528030|Device|WAVE device|WAVE applies a transcutaneous vibration to the soles of the foot and palms of the hand to elicit nerve signalling from pressure and other limb proprioceptor sensors to pontine, cerebellar, and medullary brain areas that coordinate limb movement and reflexively activate brain areas controlling breathing. The WAVE device is a battery-operated product to reduce the episodes of Apnoea of Prematurity by vibratory stimulation to the hand and foot.
15790624|NCT04528017|Device|Verofilcon A contact lenses|Spherical soft contact lenses for daily disposable wear
15790625|NCT04528017|Device|Somofilcon A contact lenses|Spherical soft contact lenses for daily disposable wear
15790626|NCT04528004|Drug|Nicotinamide riboside|Nicotinamide riboside 250mg capsules
15790627|NCT04528004|Other|Placebo|Matching placebo 250mg capsules
15790632|NCT04527978|Device|Verofilcon A contact lenses|Spherical soft contact lenses for daily disposable wear
15790633|NCT04527978|Device|Nesofilcon A contact lenses|Spherical soft contact lenses for daily disposable wear
15790634|NCT04527965|Other|Customized diet to reduce liver fat|"Ad libitum diet high in plant-derived PUFA and lower in carbohydrates
~Carbohydrates: 30 E% Fat: 50 E% (PUFA 10-15 E%) Protein: 20 E%
~Key foods are provided"
15790635|NCT04527965|Other|Healthy Nordic diet|"Ad libitum diet, based on Nordic foods, high in carbohydrates (high fiber/low GI) and lower in fat
~Carbohydrates: 50-55 E% Fat: 25-30 E% (PUFA 5-7.5 E%) Protein: 20 E%
~Key foods are provided"
15790636|NCT04527965|Other|Control|"Ad libitum diet in accordance with the Nordic Nutrition Recommendations
~Key foods are provided"
15790637|NCT04527952|Behavioral|Online handouts describing how to follow each diet for 1 week each|Participants will receive handouts via email about how to follow each diet
15790638|NCT04527939|Procedure|three-dimensional endorectal ultrasonography|three-dimensional endorectal ultrasonography
15790639|NCT04527926|Behavioral|STEPuP Intervention|"Project STEPup has 4 components designed to address barriers to MAT and EBP adoption: 1) a hub and spoke remotely-supported provider education and training program, 2) addiction teleconsultation support, 3) case management and telepsychiatry support, and 4) a partnership with health system administrators and payers to address administrative and reimbursement related needs."
15790640|NCT04527926|Behavioral|Usual Care|Standard of Care
15790666|NCT04527705|Procedure|Non-surgical root canal retreatment|Non-surgical root canal retreatment
15790667|NCT04527692|Other|Questionnaire|semi-structured interviews on the quality of life
15790641|NCT04527913|Behavioral|Interdental Oral Hygiene Instruction (Int-OHI)|"Int-OHI will be given focusing on the interdental device of the allocated group for each patient and will be given only once at timepoint T0. No further formal Int-OH instructions will be given, unless specifically asked by the patient.
~Int-OHI will be delivered by trained dental hygienist/periodontist."
15790642|NCT04527913|Procedure|One session of professional supragingival scaling and polishing|A session of professional supragingival scaling and polishing: instrumentation will be performed by a trained dental hygienist/periodontist with great care in performing exclusively coronal maneuver. No instrumentation or exploring of the gingival crevice/ sulcus will be performed.
15790643|NCT04527913|Procedure|Oral Hygiene Instruction (OHI)|"OHI will be given focusing on manual toothbrushing and will be given only once at timepoint T0. No further formal OH instructions will be given, unless specifically asked by the patient.
~OHI will be delivered by trained dental hygienist/periodontist."
15790644|NCT04527900|Drug|carboplatin and paclitaxel|carboplatin and paclitaxel 5-6 cycles (dosage per standard of care according to treating oncologist)
15790645|NCT04527900|Radiation|pelvic IMPT (Intensity Modulated Proton Therapy)|whole pelvis will receive a total dose of 4500 cGy in 25 fractions to 5040 cGy in 28 fractions
15790646|NCT04527887|Drug|Dextenza (IDI) (Sustained Release Dexamethasone), (0.4 mg)|Intracanalicular dexamethasone insert contains 0.4 mg dexamethasone and is designed to provide a sustained and tapered release of therapeutic levels of dexamethasone to the ocular surface for up to 30 days for the reduction of postsurgical inflammation and pain associated with ocular surgery.
15790647|NCT04527887|Other|ProLong™ collagen plugs|The long term synthetic punctal plug is composed of an absorbable copolymer material and measures 0.4mm in diameter and 2.0mm in length.
15790648|NCT04527874|Behavioral|VITAL model|"The concept of the VITAL, an automated differentiated service delivery model (aDSDM), is to use viral load results, other clinical characteristics (TB screening results and CD4 cell counts, comorbidities) and participants' preference to automatically triage participants into groups requiring different levels of attention and care. Innovatively, triaging of participants will be done automatically making use of a dedicated mobile App and a viral load database platform.
~To ensure effective flow of information and empowerment of patients, viral load results and other relevant information is sent directly to participants' phones, whereas health care providers receive results directly on their study tablet together with the recommended action. Further features of the platform are preference-based tailored adherence reminders and automated calls to participants for symptomatic tuberculosis screening."
15790649|NCT04527861|Procedure|Single-incision Laparoscopic Surgery|In this group，the surgery is performed through a single incision. The surgeon will adjust surgical position to expose the operative field with the help of gravity. Besides，hand over hand cross and parallel techniques are needed to achieve the SILS. All the other operative procedures are the same as conventional laparoscopic surgery.
15790650|NCT04527861|Procedure|Conventional Laparoscopic Surgery|In this group，the surgery is performed through 3-5 ports according to the surgeons habits and specific conditions.
15790651|NCT04527848|Drug|small amount of undiluted C3F8|vitrectomy followed by peeling of the internal limiting membrane and, after that, intraocular gas injection
15790652|NCT04527835|Diagnostic Test|ELIZA, Extraction of nucleic acid ,Determination of viral genome by using PCR, Quantitative real-time PCR to assess viral load ,Immunohistochemistry analysis of EMB.|ELIZA, Extraction of nucleic acid ,Determination of viral genome by using PCR, Quantitative real-time PCR to assess viral load ,Immunohistochemistry analysis of EMB.
15790653|NCT04527822|Other|Nurse led discharge planning program|a discharge planning program. It is a modified discharge planning program depends basically on the Re-Engineered Discharge program which is a program developed by Boston Medical Center in collaboration with AHRQ , 2013. The intervention consists of several components. The program components include making appointments for follow-up care (e.g., medical appointments and post discharge tests/labs). Plan for the follow-up of results from tests or labs that are pending at discharge. Identify the correct medicines and a plan for the patient to obtain them. Teach a written discharge plan the patient can understand. Educate the patient about his or her diagnosis and medicines. Review with the patient what to do if a problem arises. Assess the degree of the patient's understanding of the discharge plan and provide a telephone reinforcement of the discharge plan
15790654|NCT04527809|Device|tDCS-active|One session of active Trasncranial Direct Current Stimulation combine to a Virtual Reality task.
15790655|NCT04527809|Device|tDCS-sham|One session of sham Trasncranial Direct Current Stimulation combine to a Virtual Reality task.
15790656|NCT04527796|Other|Rehabilitation|"During the rehabilitation program a multidisciplinary team, consisting of a pneumologist, dietician, psychologist, social worker and several physiotherapists, coach the cystic fibrosis patients.
~The physiotherapists help with autogenic drainage and aerosol therapy (2-3 times/day) and supervise physical activity (5, 1-hour lasting, training sessions/week: swimming 2, Fitness training 2, 1 session of choice). The dietician calculates basal and theoretical energy needs . A carbohydrate-rich snack before exercise, to improve exercise tolerance and a carbohydrate-protein-rich snack afterwards to improve recuperation is provided."
15790657|NCT04527783|Other|experimental group|Each subject will undergo 10 rehabilitation sessions 2-3 times a week, lasting around 30'.
15790658|NCT04527783|Other|control group|Each subject will undergo 10 rehabilitation sessions 2-3 times a week, lasting around 30'.
15790659|NCT04527770|Drug|Dexamethasone|Ultrasound guided median nerve hydrodiseection using dexamethasone or midazolam
15790660|NCT04527757|Procedure|Inhalation induction|For the inhalation induction sevoflurane will be used (in the mixture with O2 + air, or O2 + N2O).
15790661|NCT04527757|Procedure|Intravenous induction|For the intravenous induction, commonly used induction anaesthetics will be used (propofol, etomidate, ketamine, midazolam).
15790662|NCT04527744|Procedure|the injection of onabotulinumtoxinA at diferent point|For experimental group, Three units of onabotulinumtoxinA (BTX-A) per site (90 hemifacies) will be initially injected at the Yonsei point. For control group，the same dose of BTX will be injected into the levator labii superioris alaeque nasi muscle, and the injection point is located 3 to 5 mm lateral to each nostril, which was a classical injection point of this treatment.
15790663|NCT04527731|Device|Accelerometry|Participants are asked to wear an accelerometer during the day for a period of seven days.
15790664|NCT04527718|Drug|Placebo|placebo as a single SC injection on Day 1;
15790665|NCT04527718|Drug|611|611 as a single SC injection on Day 1;
15790668|NCT04527679|Drug|GC combined Lenvatinib|"GC chemotherapy D1 Cisplatin 25mg/m2+ gemcitabine 1g/m2, D8 gemcitabine 1g/m2 Three weeks is a course of treatment, a total of 8 courses.
~Lenvatinib (<60kg: 8mg /d; ≥60kg, 12mg)."
15790669|NCT04527666|Drug|Anticoagulation Agents|Patients receive anticoagulation agents including low molecular weight heparin, warfarin, rivaroxaban, et al.
15790670|NCT04527653|Device|Tixel|Non-invasive thermo-mechanical treatment
15790671|NCT04527640|Dietary Supplement|Synbiotics containing Lactobacillus acidophilus & Bifidobacterium longum 5x10^9 CFU and FOS 60 mg|Patients will undergo baseline examination including medical history and physical examination, blood samples will be collected for hemoglobin, WBC, platelet, urea, creatinine, albumin and indoxyl sulfate level. Patients will be asked to complete 2 questionnaires the PAC-SYM and PAC-QOL questionnaires, and will undergo food recall evaluations by a nutritionist. They will then be given 2 capsules of synbiotics per day for 30 days. After 1 month of intervention, the patients will be evaluated for food recall and side effects. Afterwards, the patients will receive 2 capsules of the same synbiotics per day for the next 30 days. After 2 months of intervention, the patients' history will be taken, they will be asked to complete the PAC-SYM and PAC-QOL questionnaires, undergo food recall examination, and side effects evaluation. Blood samples will be taken for indoxyl sulfate examination.
15790672|NCT04527640|Other|Placebo|Patients will undergo baseline examination including medical history and physical examination, blood samples will be collected for hemoglobin, WBC, platelet, urea, creatinine, albumin and indoxyl sulfate level. Patients will be asked to complete 2 questionnaires the PAC-SYM and PAC-QOL questionnaires, and will undergo food recall evaluations by a nutritionist. They will then be given 2 capsules of placebo per day for 30 days. After 1 month of intervention, the patients will be evaluated for food recall and side effects. Afterwards, the patients will receive 2 capsules of the same placebo per day for the next 30 days. After 2 months of intervention, the patients' history will be taken, they will be asked to complete the PAC-SYM and PAC-QOL questionnaires, undergo food recall examination, and side effects evaluation. Blood samples will be taken for indoxyl sulfate examination.
15790673|NCT04527627|Behavioral|Nursing Empowerment Intervention|"Nursing empowerment intervention The intervention will be carried out during the ICU discharge planning. A Patient Information Guide for Intensive Care Unit patients will be developed.
~The guide will be based on the findings obtained in a previous qualitative study and on previous studies on patient empowerment and education. Its structure will take into account the dimensions of empowerment: bio-physiological, functional, social, experience, ethics and the financial aspect. The guide will be reviewed by experts in the development of information guides for patients and family members and will be evaluated by the participating ICUs before use.
~EG patients will receive the intervention verbally and in booklet format from the study nurses at each ICU."
15790675|NCT04527588|Other|Questionaire Michigan|Patient-Reported Outcome Measures (PROMs) are important clinical items for evaluating injuries and recovery of the hand. The Michigan Hand Questionnaire is one of the most important.
15790676|NCT04527575|Biological|EpiVacCorona (EpiVacCorona vaccine based on peptide antigens for the prevention of COVID-19)|EpiVacCorona vaccine is intended to prevent COVID-19. The vaccine relies on chemically synthesized peptide antigens of SARS-CoV-2 proteins, conjugated to a carrier protein and adsorbed on an aluminum-containing adjuvant (aluminum hydroxide). The EpiVacCorona vaccine contributes to the development of protective immunity against SARS-CoV-2 coronavirus following two intramuscular administrations spaced 21-28 days apart.
15790677|NCT04527575|Other|Placebo (sodium chloride bufus, solvent for the preparation of dosage forms for injection 0.9%)|The use of placebo: intramuscularly, twice, spaced 21 days apart, at a dose of 0.5 ml (43 volunteers)
15790678|NCT04527562|Drug|Colchicine|Participants in this group will be given a starting dose of 1.2 mg of Colchicine (2 tablets of 0.6 mg )single or 12 hourly divided dose. After that, they will take colchicine 0.6mg daily for 13 days. If they develop gastro intestinal side effects e.g abdominal pain, burning, vomiting, diarrhea, omeprazole and antiemetic will be prescribed. Supportive care and treatment will also be given.
15790679|NCT04527562|Drug|Placebo|Participants in this group will be given a starting dose of 2 tablets of Placebo, single or 12 hourly divided dose. After that, they will take one placebo tablet daily for 13 days.Placebo tablet will be identical with the Colchicine tablet. If patients develop gastro intestinal side effects e.g abdominal pain, burning, vomiting, diarrhea, omeprazole and antiemetic will be prescribed. Supportive care and treatment will also be given.
15790680|NCT04527549|Drug|Dabrafenib Mesylate|Given PO
15790681|NCT04527549|Drug|Hydroxychloroquine Sulfate|Given PO
15790682|NCT04527549|Drug|Placebo Administration|Given PO
15790683|NCT04527549|Drug|Trametinib Dimethyl Sulfoxide|Given PO
15790684|NCT04527536|Diagnostic Test|Neonatal hyperbilirubinemia|Neonatal hyperbilirubinemia：The total serum bilirubin exceeds the 95th percentile of the Bhutani neonatal hourly bilirubin nomogram.
15790685|NCT04527523|Diagnostic Test|Optical Coherence Tomography|OCT is an imaging method that uses light waves to create images of the retina.
15790686|NCT04527510|Diagnostic Test|double reading|"Screening ABUS are independently reviewed by two readers, each of whom reports on any abnormalities and decides whether a participant is recalled for further assessment or returned home to routine screening. In the event there is disagreement between the readers' findings, a third reader acts as an arbitrator by rendering an interpretation of the ABUS and making the final decision to recall the participant or return to routine screening.
~the image will be remotely transmitted to the image reading centers."
15790687|NCT04527510|Diagnostic Test|second-reading|"ABUS are reviewed initially by a reader who reports on any abnormalities. The reader then re-examines the ABUS with the aid of AI, a system that uses computer prompts to recall suspicious features or abnormalities that may have been overlooked or previously dismissed as being normal. Based on these evaluations, a recommendation is made by the reader to either recall the participant for further assessment or return home to routine screening.
~the image will be remotely transmitted to the image reading centers."
15790688|NCT04527510|Diagnostic Test|concurrent-reading|readers only identify AI marks . the image will be remotely transmitted to the image reading centers.
15790689|NCT04527484|Drug|SHR-1314|each group subjects will be given different formulations of SHR-1314
15790690|NCT04527471|Drug|Ensifentrine Dose 1|Study drug delivered twice daily via pMDI
15790691|NCT04527471|Drug|Placebo pMDI|Placebo delivered twice daily via pMDI
15790696|NCT04527445|Procedure|Reduced radiation fluoroscopy|See previous information about each arm
15790697|NCT04527445|Procedure|Conventional fluoroscopy|See previous information about each arm
15790698|NCT04527432|Other|Survey|Survey at baseline, 6 and 12 months
15790699|NCT04527432|Diagnostic Test|SARS-CoV-2 antibody test|SARS-CoV-2 antibody test results and testing again at 6 and 12 months
15790700|NCT04527419|Procedure|Systematically mediastinal lymph node dissection|Patient would receive systematically mediastinal lymph node dissection in surgery in the two arms, respectively.
15790701|NCT04527419|Procedure|No systematically mediastinal lymph node dissection|Patient wouldn't receive systematically mediastinal lymph node dissection in surgery in the two arms, respectively.
15790702|NCT04527406|Procedure|posterior hemivertebra resection|The subjects in early surgical group are arranged to be admitted to for surgical treatment very soon. The operation choice is posterior hemivertebrae resection + posterior pedicle screw placement + scoliosis correction. During operation pedicle screws are placed in the adjacent vertebrae of the head and tail of the Hemivertebra. Wedge resection of the hemivertebrae is performed afterward. Finally, two rods are placed between the pedicle screws. Intraoperative fluoroscopy confirms that the internal fixation position is good.
15790703|NCT04527406|Procedure|conservative treatment+ delayed posterior hemivertebra resection|In traditional surgical group, subjects received conservative treatment firstly with custom-made braces to delay the progression of scoliosis. It is planned to use the classic posterior hemivertebrae resection + posterior pedicle screw placement + scoliosis correction to complete the correction around the age of 5. The operation choice is identical with early surgical group. During operation pedicle screws are placed in the adjacent vertebrae of the head and tail of the Hemivertebra. Wedge resection of the hemivertebrae is performed afterward. Finally, two rods are placed between the pedicle screws. Intraoperative fluoroscopy confirms that the internal fixation position is good.
15790704|NCT04527393|Drug|Individualized oral morphine|"Analgesic effectiveness is assessed using the Faces Scale by the parents every four hours from postoperative Day 1 to Day 10 (eg: 8:00, 12:00, 16:00, and 20:00, each day).
~If the Faces Scale score > 6, the child receive rescue oral morphine analgesia. Patients with positive results of fentanyl test receive oral morphine 100μg/kg per dose, while patients with negative results receive oral morphine 500μg/kg per dose."
15790705|NCT04527393|Drug|Conventional oral morphine|"Analgesic effectiveness is assessed using the Faces Scale by the parents every four hours from postoperative Day 1 to Day 10 (eg: 8:00, 12:00, 16:00, and 20:00, each day).
~If the Faces Scale score > 6, the child receive rescue oral morphine analgesia. Patients receive oral morphine 200μg/kg per dose."
15790708|NCT04527367|Procedure|Innovative medical technologies in invasive cardiology and cardiac surgery|A follow-up study included the analysis of medical documentation of the Cardiosurgery and the Invasive Cardiology Departments to provided information on the duration and type of procedure performed.
15790709|NCT04527354|Drug|Treamid|Participants will receive Treamid 50 mg once a day during 4 weeks
15790710|NCT04527354|Drug|Placebo|Participants will receive Placebo once a day during 4 weeks
15790711|NCT04527328|Device|AKST1210|AKST1210 apheresis column
15790712|NCT04527328|Device|Control|Control object to mimic column
15790713|NCT04527328|Procedure|Hemodialysis|Hemodialysis
15790714|NCT04527315|Other|Questionnaires|Various questionnaires will be used to assess short and long-term impacts of depression, anxiety, and other indicators of overall mental health and quality of life
15790715|NCT04527302|Combination Product|ERP combined with high-definition transcranial direct current stimulation|"Patients will achieve the exposure based CBT for total 10 times excluding 8 sessions of ERP. Structured protocol described by Foa et al., 2012. Specially, patients will get the first CBT session in the first week for 90 minutes in order to gather detailed information of individuals' symptom. Then the next 2 weeks, patients will get ERP session twice a week. From the fourth week to the seventh week, patients weill get ERP session once a week. In the end of the eighth week, patients will get the last session of the exposure-based CBT for relapse prevention.
~The tDCS device will deliver a direct current of 1.5mA during 20 minutes. Anode electrode will be localized in front of the mPFC on the FpZ point according to the EEG international reference. Four cathode electrodes will be placed around (i.e. AF7, AF8, F3, F4)."
15790716|NCT04527302|Combination Product|ERP combined with sham tDCS|Patients will also treated with the same exposure based CBT agenda as the ERP+tDCS group . And simultaneously, thet were also undertook the sham tDCS. The sham tDCS device is the same as the active comparator's except that the sham tDCS will only deliver a current stimulation for the first and last 15 seconds.
15790717|NCT04527289|Drug|Amantadine (100mg) as add on therapy.|Amantadine (100mg) as add on therapy to the management regimen of traumatic brain injury - 100mg twice daily Oral or feeding tube
15790718|NCT04527289|Drug|Placebo|patients will be managed with placebo as add on to the standard regimen.
15790719|NCT04527276|Other|Oral care with 0,12% Chlorhexidine|0, 12 % CHX, and standard oral care with 0,9% NaCl were compared to assess VAP rates. Both solutions were applied to critically ill children who were intubated.
15790720|NCT04527263|Diagnostic Test|measurement of urinary 5-HIAA|urinary assessment of 5-HIAA
15790721|NCT04527250|Drug|ASC41|ASC41,1mg/table;5mg/table
15790722|NCT04527250|Drug|ASC41 placebo|ASC41 placebo,1mg/table;5mg/table
15790723|NCT04527237|Other|acupressure|"The person will be given 2 applications a day at 12-hour intervals and 6 applications in 72 hours in total. The session duration of an individual will be approximately 25 minutes.
~Physiological measurements will be made before and after the acupressure application. Physiological measurements 10-15 min. From acupressure application. will be taken before and the same measurements after acupressure 20-30. Will be taken again in the min interval. In addition, the Continuous Anxiety Scale will be applied once before application, the State Anxiety Scale will be applied once before the application and 3 times in total after the application at the end of every 24 hours. Sleep Scale will be applied 3 times in total before the next day after application."
15790724|NCT04527237|Other|Placebo|Unlike acupressure, it will only be in contact with gloves, to reduce the electrical effect of touch, away from the actual acupressure points.
15790725|NCT04527224|Drug|AstroStem-V|Allogenic adipose tissue-derived mesenchymal stem cells (AdMSCs)
15790726|NCT04527211|Drug|Ivermectin|Oral administration of ivermectin 200 mcg/kg every week for seven weeks
15790727|NCT04527198|Diagnostic Test|Brainstem Responses Assessment Sedation Score (BRASS)|"It consists of a standardized evaluation of brainstem reflexes with a score of 1 attributed for absence of pupillary light reflex, cough reflex and the combined absence of grimace and oculocephalic reflex, a score of 2 for absent corneal reflex and a score of 3 for absent grimace in the presence of oculocephalic The resulting sum ranges from 0 to 7.
~It will be performed at two times points: a first time under sedation and a second time 3 to 5 days after sedation weaning."
15790728|NCT04527198|Diagnostic Test|Electroencephalogram with EKG lead|"A 20 minutes clinical (12 electrodes) EEG with an EKG lead will be performed a first time under sedation and a second time 3 to 5 days after sedation weaning.
~These EEG recordings will allow to measure the sympathic-parasympathetic ratio using spectral analysis of the EKG and also to measure quantitative markers of brain EEG activity (spectral power and connectivity in delta, theta, alpha, beta and gamma band; complexity)."
15790729|NCT04527185|Drug|Endotoxin|Endotoxin 0.4ng/kg i.v.
15790730|NCT04527172|Diagnostic Test|neuromuscular ultrasound|ultrasound to visualize the peripheral nerves of lupus patients and to compare it with results of the raditional electrophysiological studies
15790731|NCT04527159|Drug|Fluoraphat Pro / VivaSens|desensitizing agents for treatment of dentinal hypersensitivity
15790732|NCT04527146|Other|IMAGINE-PD|The Interactive, Multimedia Approach to Genetic Counseling to INform and Educate in Parkinson's Disease (IMAGINE-PD) is a novel, interactive, web-based, audiovisual, self-guided, genetic counseling tool in the development phase. Essential genetic counseling themes, outlined by a senior certified clinical genetics counselor in accordance with national guidelines, are presented in a web-based format, utilizing videos, text, pictures, and audio. Participants can interact with IMAGINE-PD at their own pace, with the ability to move backward and forward, repeat sections, and have the ability to submit questions to the genetic counselor via e-mail.
15790733|NCT04527146|Other|Virtual genetic counseling|The virtual visits will be conducted by a certified genetic counselor to provide all counseling in accordance with guidelines set forth by the National Society of Genetic Counselors. The counseling visit will be conducted in real-time on an established and secure audiovisual conferencing telemedicine platform (BlueJeans) within the PennChart/EPIC electronic medical record dashboard.
15790734|NCT04527146|Other|Telephone genetic counseling|The telephone counseling will be conducted by a certified genetic counselor to provide all counseling in accordance with guidelines set forth by the National Society of Genetic Counselors.
15790735|NCT04527133|Drug|Aprotinin|Intravenous or inhalation
15790736|NCT04527120|Other|indigenously developed ultrasound phantom (IDUP)|Ultrasound phantom model developed in the department of Emergency Medicine of Jubilee Mission Medical College, to train vascular access.
15790737|NCT04527107|Drug|THR-149 dose level 1|3 intravitreal injections of THR-149 dose level 1, 1 month apart
15790738|NCT04527107|Drug|THR-149 dose level 2|3 intravitreal injections of THR-149 dose level 2, 1 month apart
15790739|NCT04527107|Drug|THR-149 dose level 3|3 intravitreal injections of THR-149 dose level 3, 1 month apart
15790740|NCT04527107|Drug|Aflibercept|3 intravitreal injections of aflibercept 2mg, 1 month apart
15790741|NCT04527107|Drug|THR-149 selected dose level|3 intravitreal injections of THR-149 selected dose level, 1 month apart
15790742|NCT04527094|Diagnostic Test|Prediction of postoperative respiratory failure using a machine learning|The performance of a machine learning model to predict postoperative respiratory failure after general anesthesia within postoperative day 7 was tested prospectively.
15790743|NCT04527081|Biological|AG0302-COVID19|2.0 mg of AG0302-COVID19 twice at 2-week intervals
15790744|NCT04527081|Biological|AG0302-COVID19|2.0 mg of AG0302-COVID19 twice at 4-week intervals
15790745|NCT04527081|Biological|AG0302-COVID19|2.0 mg of AG0302-COVID19 three times at 2-week intervals
15790746|NCT04527068|Drug|Bevacizumab|7.5 mg/kg intravenously every 3week
15790747|NCT04527068|Drug|Tripleitriumab|240mg intravenously every 3week
15790748|NCT04527055|Drug|Bismuth Subcitrate 120 MG Oral Tablet|Bismuth Subcitrate (120 MG Oral Tablet) 1 tab per oral four times per day for 14 days in the14-day bismuth-based quadruple therapy and for 10 days in the10-day bismuth-based quadruple therapy
15790749|NCT04527055|Dietary Supplement|Lactobacillus acidophilus and Bifidobacterium lactis Bb12|"The probiotic powder per oral twice daily for 24 weeks. The probiotic powder is named as President AB powder, which contains an approximately equal mixture of Lactobacillus acidophilus and Bifidobacterium lactis Bb12 at a concentration of >= 10E9 CFU/mL (President Corp., Tainan, Taiwan)."
15790750|NCT04527055|Drug|Esomeprazole 40mg|Esomeprazole (40 mg) 1 tab per oral twice per day for 14 days in the14-day bismuth-based quadruple therapy and for 10 days in the10-day bismuth-based quadruple therapy
15790751|NCT04527055|Drug|Metronidazole 250 MG|Metronidazole (250 MG) 2 tab per oral thrice per day for 14 days in the14-day bismuth-based quadruple therapy and for 10 days in the10-day bismuth-based quadruple therapy
15790752|NCT04527055|Drug|Tetracycline Pill|Tetracycline (250 MG) 2 tab per oral four times per day for 14 days in the14-day bismuth-based quadruple therapy and for 10 days in the10-day bismuth-based quadruple therapy
15790753|NCT04527042|Drug|Rivaroxaban|It is determined by the clinician's routine clinical prescription.
15790754|NCT04527029|Other|No interventions|It is an observational study. No interventions.
15790757|NCT04527003|Drug|Cannabidiol (CBD) Extract|Cannabis is a well-known plant that contains more than 500 identified phytochemicals of which over 100 are cannabinoids. The most widely studied is 9-tetrahydrocannabinol (9-THC), which is the major psychoactive component of Cannabis, but Cannabidiol (CBD) has been increasingly favored for its reduced side effect profile and potential health benefits. CBD was first isolated from Cannabis in the 1940s. CBD, unlike 9-THC, does not bind to CB1 and CB2 receptors, which accounts for its lack of typical psychotropic effects, but is still appears to work via alternative mechanisms via the endocannabinoid system.
15790758|NCT04527003|Drug|Norethindrone Acetate|Norethindrone is a form of progesterone, a female hormone important for regulating ovulation and menstruation.
15790759|NCT04527003|Other|Placebo|a substance or treatment which is designed to have no therapeutic value
15790760|NCT04526990|Biological|Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)|Intramuscular administration
15790761|NCT04526990|Biological|Placebo|Intramuscular administration
15790763|NCT04526964|Behavioral|Self-management curriculum|The Intervention starts during inpatient phase after relocation of potential study participants from the intensive care unit to normal ward and after informed consent to participate. Those subjects assigned to the CGr by randomization code receive standard care at the respective center. Subjects assigned to the IGr received, in addition to standard care, a multi-modular self-management training carried out at the respective center. The content of the self-management training should be deepened and consolidated through a supplementary app. Training is performed during inpatient post-implant phase, as well as one refresher session about six weeks after discharge during regular outpatient follow-up. The intervention lasts 3 months, plus a 9-month follow-up per subject. The content of the self-management training is based on current evidence and was written in a curriculum to achieve the highest possible standardization, taking into account the center specifics.
15790764|NCT04526951|Drug|Intravenous injection of Tenecteplase and one dose of placebo tablet|Drug: Tenecteplase Tenecteplase administered as an intravenous injection (0.25 mg/kg body weigh; maximum 25 mg)
15790765|NCT04526951|Drug|One tablet of Acetylsalicylic Acid and one dose of IV placebo|300 mg Acetylsalisylic acid
15790767|NCT04526925|Device|Respiratory filter in-line placed with the standard mouthpiece|The respiratory filter is a device that removes solid/large particles from gas
15790768|NCT04526925|Other|Standard mouthpiece|The mouthpiece is the interface that is placed on participant's face in order to measure all the breathing physilogic responses
15790769|NCT04526912|Drug|VIB7734|Single subcutaneous dose
15790770|NCT04526912|Drug|Placebo|Intravenous single dose matched to VIB7734.
15790771|NCT04526899|Biological|BNT111|IV injection
15790772|NCT04526899|Biological|Cemiplimab|IV infusion
15790774|NCT04526873|Behavioral|Postcard|Mailed
15790775|NCT04526873|Behavioral|Phone call|May be automated or by human
15790776|NCT04526873|Behavioral|Humor/Salience|Funny cartoon + health risk examples
15790777|NCT04526873|Behavioral|Telehealth|Information about video visit
15790778|NCT04526860|Other|Calibration of infant breast milk and formula milk intake|We will calibrate (reduce) the pumped breast milk or formula intake of infants of overweight and obese mothers who exceed 2 standard deviations of normal WHO weight standards, in order to prevent infant obesity and subsequent childhood obesity.
15790779|NCT04526847|Behavioral|Intermittent energy restriction (IER) : 5:2 diet pattern|Participants in the IER group will be provided menus on fasting day that provide ~25% of the individual energy requirement (400 kcal/day for females and 600 kcal/day for males) that means ~75% energy restriction per week (Sundfør et al., 2018; Svendsen, 2018; Templeman, Gonzalez, Thompson, & Betts, 2020). The recommended fasting day may be on two non-consecutive days (Mondays and Thursdays) per week and remaining five days of the week will be based on the usual diet plan. All participants will be instructed to complete all food by 12 pm and then fast until 8 am the following day (Svendsen, 2018).Thus, the weekly average calorie intake will correspond to ~75% of the normal energy requirements. They will receive a diet plan that recommended ~50 gm protein/day from chicken breast, lean meat, lean fish, fat-free yogurt, cottage cheese, egg or legumes, and vegetables to increase satiety on fasting days.
15790780|NCT04526847|Behavioral|Continuous energy restricted (CER) group|Participants in the CER group will be advised to reduce total energy intake to 1200-1550 kcal in all seven days a week. They will be provided diet plan calculated in relation to each person's estimated energy requirements. Menus will be divided into breakfast, lunch, dinner, and snacks in line with their individualized energy recommendations. They will be requested to consume ~75% of the individual energy requirements daily (25% energy restriction of calculated baseline energy requirements daily) over six months. Thus, the overall energy restriction will similar between the groups at an estimated reduction of 25% of requirements. Participants will be randomized in a 1:1 ratio, and assigned to an intermittent or continuous energy restriction group randomly.
15790781|NCT04526834|Drug|CD30.CAR-T|"Bendamustine and Fludarabine (3 days)
~Dose level 1: 2 x 108 cell/m2 CD30.CAR-T (Day 0)
~Dose level 2: 4 x 108 cell/m2 CD30.CAR-T (Day 0)
~Dose level 3: 6 x 108 cell/m2 CD30.CAR-T (Day 0)"
15790782|NCT04526821|Dietary Supplement|Bovine Lactoferrin|Bovine Lactoferrin 600mg daily for 12 weeks (3 chewable tablets of 100mg , twice a day), for 12 weeks plus personal portection provided from the hospital.
15790783|NCT04526821|Dietary Supplement|Maltodextrin|Maltodextrin 600mg daily for 12 weeks (3 chewable tablets of 100mg, twice a day), for 12 weeks plus personal portection provided from the hospital.
15790784|NCT04526808|Other|FODMAP diet|low FODMAP diet
15790785|NCT04526795|Drug|Cytarabine|Given IV
15790786|NCT04526795|Drug|Fludarabine|Given IV
15790787|NCT04526795|Drug|Pegcrisantaspase|Given IV
15790788|NCT04526782|Drug|Encorafenib 75 MG|450 mg (6 × 75 mg capsule) per day
15790789|NCT04526782|Drug|Binimetinib 15 MG|45 mg (3 × 15 mg tablet) twice daily
15790790|NCT04526782|Drug|Docetaxel|75 mg/kg (D1=D22)
15790791|NCT04526769|Diagnostic Test|Tear Collection|"A microcapillary tube will be placed at the corner of the eyelid so tears can be absorbed to the tube without causing any trauma. The tube will be placed in a transfer tube. Standard virus sampling swabs will be used to collect samples from the same patient's nasopharynx. RT-PCR will be run to determine virus yield in each sample.
~For the second part of the study, IHC staining will be done on the existing ocular tissue pathology slides to detect the expression of ACE2 and other cell surface and intracellular receptors. The investigators will use existing UMN ocular pathology lab and Lion's Eye Bank tissue samples. These are banked tissue samples that were collected and examined previously and then the remaining tissue samples were stored."
15790792|NCT04526756|Procedure|Mechanical Thrombectomy|Solitaire stent and manual aspiration thrombectomy were performed as the first-line endovascular treatment
15790793|NCT04526743|Behavioral|Questionnaire|Psychological and behavioral variables will be collected using questionnaires that have been validated in our setting and will be completed by the patients themselves online.
15790794|NCT04526730|Drug|Tavo|Tavo will be injected on Days 1 and 8 every 4 weeks at a dose volume of ¼ of the calculated lesion volume with a minimum dose volume per lesion of 0.1 mL for lesions of volume <0.4 cm3
15790795|NCT04526730|Drug|Nivolumab|Nivolumab will be administered 480 mg every 4 weeks over 30 minute infusions
15790796|NCT04526730|Device|OncoSec Medical Electroporation Therapy System|"The OMS (OncoSec Medical Electroporation Therapy System), a medical EP device system, consists of 3 components: 1. an Electroporation Generator that generates electric pulses, 2. a sterile Applicator Tip containing needle array, and 3. an Applicator Handle that connects to the Electroporation Generator at the proximal end and connects to the Applicator Tip at the distal end.
~Upon user activation of the attached Foot Switch, the OMS Electroporation Generator delivers controlled electrical pulses in a square wave pulse pattern yielding optimal transmembrane potential for electroporation to occur. EP pulses occur between 6 hexagonal opposing needle electrodes. After the first pulse, the polarity between the opposing needle electrode pairs is reversed and the needle pair is pulsed again. After the initial paired pulse, the pulse delivery is rotated clockwise to the next opposing needle pairs until a total of 6 pulses are delivered to complete the EP sequence."
15790797|NCT04526717|Drug|MPT0B640|Each dose of MPT0B640 will be administrated per Cohort. (15, 30, 60, 80, 100 mg of MPT0B640)
15790798|NCT04526704|Drug|Pexidartinib|200 mg capsules administered orally twice daily on an empty stomach (at least 1 hour before or at least 2 hours after a meal or snack)
15790803|NCT04526678|Dietary Supplement|Iron supplement (27mg)|The participants will be randomized to an intervention group or a control group. The intervention group will ingest 27mg iron daily for three months.
15790804|NCT04526665|Drug|Elafibranor 80mg|Elafibranor 80mg for double blind period (52 to 104 weeks). After completion of the double blind period, participants will be offered the opportunity to enter an open label long term extension study for up to 5 years. Participants will continue the elafibranor dose received during the double blind period.
15790805|NCT04526665|Drug|Placebo|Placebo for double blind period (52 to 104 weeks). After completion of the double blind period, participants will be offered the opportunity to enter an open label long term extension study and to switch to elafibranor 80mg for up to 5 years.
15790808|NCT04526639|Behavioral|Virtual Reality-based Interactive Cognitive Training Program|Three virtual reality-based games designed to train inhibitory control, working memory, and cognitive flexibility among children with TBI
15790809|NCT04526639|Behavioral|Placebo Virtual Reality Game|A virtual playground for control group to interact without training executive functions
15790810|NCT04526626|Device|Radiofrequency ablation for treatment of lower limb varicose veins (ClosureFast, Medtronic)|Thermal injury to long saphenous vein
15790811|NCT04526600|Other|Fidget ball|Access to a prototype 'smart' fidget ball with pressure sensors embedded, that produces touch traces and transmits real time data
15790812|NCT04526587|Other|Cytology Specimen Collection Procedure|Undergo collection of blood, tissue, ascites or pleural effusions, and fresh body fluids or fresh biopsy samples
15790813|NCT04526587|Other|Diagnostic Laboratory Biomarker Analysis|Correlative studies
15790814|NCT04526587|Other|Medical Chart Review|Patient's electronic health records are reviewed
15790818|NCT04526561|Procedure|Thoracodorsal artery perforator flap (TDAP) to axilla|Reconstruction of axillary hidradenitis suppurativa
15790819|NCT04526561|Procedure|Latissimus dorsi flap|Breast reconstruction
15790820|NCT04526561|Procedure|Thoracodorsal artery perforator flap (TDAP) to breast|Breast reconstruction
15790821|NCT04526561|Procedure|Limberg flap|Reconstruction of axillary hidradenitis suppurativa
15790822|NCT04526535|Diagnostic Test|Lung ultrasound|Lung ultrasound performed with a portable device with an 8 zones protocol within the first 24 hours after and acute myocardial infarction
15790823|NCT04526522|Other|No intervention|No intervention
15790824|NCT04526509|Drug|GSK3901961|GSK3901961 as an IV infusion.
15790825|NCT04526509|Drug|GSK3845097|GSK3845097 as an IV infusion.
15790826|NCT04526509|Drug|Fludarabine|Fludarabine will be used as lymphodepleting chemotherapy and will be administered via IV route.
15790827|NCT04526509|Drug|Cyclophosphamide|Cyclophosphamide will be used as lymphodepleting chemotherapy and will be administered via IV route.
15790828|NCT04526496|Drug|FTP-198, single dose|Single dose of FTP-198, 6 dose levels, oral suspension
15790829|NCT04526496|Drug|Placebo, single dose|Placebo matched to FTP-198, oral suspension
15790830|NCT04526496|Drug|FTP-198, multiple doses|Multiple doses of FTP-198, 3 dose levels, oral suspension, 7 days
15790831|NCT04526496|Drug|Placebo, multiple doses|Placebo matched to FTP-198, oral suspension, 7 days
15790832|NCT04526483|Device|Laparoscopic gastrectomy with Intelligent Navigation 4K UHD 3D Endoscopic Imaging System|Laparoscopic gastrectomy with Intelligent Navigation 4K UHD 3D Endoscopic Imaging System
15790833|NCT04526470|Drug|Alpelisib|Dose level -2: 200 mg PO once daily / Dose level -1: 200 mg PO once daily / Dose level 0: 250 mg PO once daily / Dose level 1: 300 mg PO once daily
15790834|NCT04526470|Drug|Paclitaxel|Dose level -2: 60 mg/m2 IV on day 1, 8, and 15 / Dose level -1: 70 mg/m2 IV on day 1, 8, and 15 / Dose level 0: 70 mg/m2 IV on day 1, 8, and 15 / Dose level 1: 70 mg/m2 IV on day 1, 8, and 15
15790835|NCT04526457|Other|Standard of Care|Randomized to standard of care with lipid testing only.
15790836|NCT04526457|Other|Genetic Testing|Randomized to genetic testing.
15790837|NCT04526444|Device|Fitness tracker|Fitness tracker Mi Smart Band 5 with the computational algorithm PAI
15790838|NCT04526444|Other|Online training|Les Mills On Demand
15790839|NCT04526444|Other|Peer support via social media|Facebook group
15790840|NCT04526431|Drug|Dosage Forms Oral|Dosage form of tacrolimus (extended release tacrolimus or immediate release tacrolimus)
15790841|NCT04526418|Device|24/7 EEG™ SubQ system|Electrographic seizure recording sensitivity of an ipsilaterally implanted 24/7 EEG™ SubQ system: proportion of identified ipsilateral seizures as compared to ipsilateral video-EEG during admission to the Epilepsy Monitoring Unit
15790842|NCT04526405|Diagnostic Test|SARS-CoV-2 S1/S2 IgG|SARS-CoV-2 S1/S2 IgG analysis
15790843|NCT04526392|Other|Questionnaire|Pubertal course questionnaire
15790844|NCT04526379|Behavioral|Questionnaires|Evaluation of behavioral disorders of children with PWS by questionnaires
15790845|NCT04526379|Device|t-VNS|Evaluation of the influence of 6 month-stimulation by t-VNS on emotional, cognitive, and behavioral/clinical characteristics of 12 children with PWS on 30 PWS patients included.
15790848|NCT04526353|Drug|Oxybutynin 1 mg/ml Syrup|"The Investigational Medicinal Product of this study is Oxybutynin 1 mg/ml Syrup (see Annex 1 for the Monograph of PMS-Oxybutynin provided by ANSM under the ATU.). It will be administered at the dose of 0.1 mg/kg/twice a day to patients randomized to the study treatment group. The dose will be adapted to the child's weight to the nearest kilogram.
~The recommended dosage for older children with neurologic bladder is 0.3 to 0.4mg/kg/day, whilst the dosage we will be using is effectively 0.2mg/kg/day. This is because we are taking into account the absence or pharmacological studies of oxybutynin use in children <1 year of age, as well as their specific liver metabolism. Furthermore, the dose of 0.1mg/kg twice daily is the dose used in children within the same age group in the study by Casey et al, 2012"
15790849|NCT04526340|Diagnostic Test|Blood sample|2 Blood samples at the beginning and end of the test to analyze; Haptoglobin phenotyping, Haptoglobin concemtration (μmol/l) (serum), Sodium (mmol/l) (serum), Osmolality (mOsm/kg) (serum), Urea (g/l) (serum), Creatinine (g/dl) (serum), Potassium (mmol/l) (serum).
15790850|NCT04526340|Diagnostic Test|Bio-impedance measurement (BIA)|for every 30 minutes for 4 hours
15790851|NCT04526340|Dietary Supplement|Ingestion of testing nutrient/food capsules|The subjects will be tested in fasted and sober state in the morning. No food/drink 6 hours prior to the test. The subjects will be asked to take 2 different dosages of testing nutrient along with 500ml of water and only water for the control, on 3 different test days. The testing nutrients will be prepared in 1g capsules.
15790852|NCT04526340|Diagnostic Test|Urine sample|3 Urine samples at the beginning, after 2 hrs and at the end of the test to analyze: Total voided volume, Osmolality (mOsm/kg), Creatinine (g/dl), Sodium (mmol/l), Potassium (mmol/l), Urea (g/l)
15790853|NCT04526327|Other|exercise|the combination of aerobic and resistive exercise, three time a week
15790854|NCT04526314|Other|observational|observational
15790855|NCT04526301|Device|Tablo Hemodialysis System|Home hemodialysis treatments ~4 times a week.
15790856|NCT04526288|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo alloHCT
15790857|NCT04526288|Drug|Liposome-encapsulated Daunorubicin-Cytarabine|Given IV
15790858|NCT04526262|Device|transcranial magnetic resonance guided focused ultrasound BBB disruption|The ExAblate BBB disruption procedure will be performed with ExAblate 4000 type 2.0 system, and this will be performed twice every 3 months.
15790859|NCT04526249|Device|rapid pulse confirmation device|device used to detect pulsatile blood blood during and after cardiac arrest
15790860|NCT04526236|Drug|Methadone Injectable Product|Perioperative use of placebo for pain management and remifentanil during the surgery.
15790861|NCT04526223|Other|comprehensive treatment regimen|"Diagnosis MF(includ Post-ET,Post-PV,PMF)
~With at least two month Ruxolitinib treatment prior to transplantation
~DAC+BF as myeloablative conditioning regimen
~received Rux at +5d in ASCT and continued to +60d"
15790862|NCT04526210|Drug|ALXN1840|ALXN1840 will be administered orally as a single dose as 4 x 15 mg enteric-coated tablets with 240 milliliters of water (fasting), for a total dose of 60 mg.
15790863|NCT04526210|Drug|Bupropion Hydrochloride|Bupropion hydrochloride will be administered orally as a single dose as one 150 milligrams (mg) tablet with 240 milliliters of water (fasting).
15790864|NCT04526197|Drug|ALXN1840|ALXN1840 will be administered orally as a single dose as 4 x 15 mg enteric-coated tablets with 240 milliliters of water (fasting), for a total dose of 60 mg.
15790865|NCT04526197|Drug|Celecoxib|Celecoxib will be administered orally as a single dose as one 200 milligrams (mg) tablet with 240 milliliters of water (fasting).
15790866|NCT04526184|Procedure|aerobic exercise with blood flow restriction|Patients and healthy individuals will be given 30 minutes of aerobic exercise by cycling, by restricting lower extremity blood flow.
15790867|NCT04526171|Behavioral|Vaparshun|Participants in the intervention clusters were encouraged to improve their existing toilets.
15790929|NCT04525651|Other|Manual Acupuncture|Manual acupuncture to acheive de qi.
15790930|NCT04525651|Other|Sham Acupuncture|Sham acupuncture to avoid de qi.
15790931|NCT04525638|Drug|177Lu-Dotatate|7.4 GBq 177Lu-DOTATATE intravenously as a 4-hours infusion
15790868|NCT04526158|Behavioral|Mobile+Group LAMP Mindfulness-Based Intervention|The Mobile+Group LAMP Mindfulness-Based Intervention (MBI) condition consists of 8, 90-minute weekly group sessions, delivered via secure video-conferencing. The program consists of educational and instructional videos presented by a trained mindfulness instructor interspersed with workbook reflections and group discussions, and daily practice exercises that participants do on their own. A trained facilitator (who is not required to be an expert in mindfulness) leads the group. Participants also have access to the mobile app and a study website, with the same educational and instructional videos that are presented in the group sessions.
15790869|NCT04526158|Behavioral|Mobile LAMP Mindfulness-Based Intervention|The Mobile LAMP Mindfulness-Based Intervention (MBI) condition consists of 8, 30- to 60-minute weekly sessions, delivered on a mobile app and available on the study website. The program consists of educational and instructional videos presented by a trained mindfulness instructor, with workbook reflections and daily practice exercises that participants do on their own. Participants will also participate in 3 phone sessions with a facilitator at the beginning, middle, and end of the program.
15790870|NCT04526145|Behavioral|Stress and emotion management|Group intervention led by a nurse and dietitian to address stress, emotion management and healthy lifestyle for African American women with hypertension. The weekly sessions will include:how to manage stress during Covid-19, taking blood pressure, interpersonal relationships skills, mindful awareness, restful sleep, physical activity, and healthy eating.
15790871|NCT04526132|Drug|Felbinac Trometamol Injection|"Felbinac Trometamol Injection diluted to 100 ml with 0.9% sodium chloride injection.Use a micro-injection pump to inject intravenously at a constant speed for 30 min (± 2 min)..
~One dose at 8h and 16h after the start of the first dose,the first intravenous infusion was started at the end of the operation (Skin suture completes the last stitch).The drug was given 3 times,3 times/day,once every 8 hours."
15790872|NCT04526132|Drug|Placebos|"Placebo diluted to 100 ml with 0.9% sodium chloride injection.Use a micro-injection pump to inject intravenously at a constant speed for 30 min (± 2 min).
~One dose at 8h and 16h after the start of the first dose,the first intravenous infusion was started at the end of the operation (Skin suture completes the last stitch).The drug was given 3 times,3 times/day,once every 8 hours."
15790873|NCT04526119|Drug|Acotiamide hydrochloride hydrate|A white film-coated tablet containing 100 mg Z-338 Administered orally, one tablet a time and three times a day before meals for 28 days in the double-blind phase Administered orally, one tablet a time and three times a day before meals for 28 days in the open-label phase
15790874|NCT04526119|Drug|Placebo|A white film-coated tablet not containing 100 mg Z-338 Administered orally, one tablet a time and three times a day before meals for 28 days in the double-blind phase
15790875|NCT04526106|Drug|RLY-4008|RLY-4008 is an oral inhibitor of FGFR2
15790876|NCT04526093|Other|TruTrace™ verified Medical Cannabis products|"With the introduction of TruTrace™ verification, cannabis products can now be genetically finger-printed and clearly identified. Key information, including DNA genetics and cannabinoid and terpene compositions can be collated into a Master Strain Certificate. This certification can then be embedded into a cannabis barcode that carries comprehensive information about the strain."
15790877|NCT04526080|Device|TheraBionic Device|Amplitude-modulated electromagnetic fields will be self-administered and given continuously to patients in three courses of 60-minute treatments per day, administered in the morning, at noon and in the evening at the patient's home, with the exception of the first 60-minute treatment, which will be delivered at the research site. Each 6-week treatment period will be considered a cycle of treatment. For subjects who are randomized to the active arm, the device will be programmed with hepatocellular carcinoma-specific modulation frequencies and will be activated for more than 200 one-hour treatment sessions.
15790878|NCT04526080|Device|Placebo Device|Subjects who are randomized to receive placebo, will receive the same instructions and a similar device. The placebo device will look and sound the same as the active device, but will not deliver the modulation frequencies. For subjects randomized to the placebo arm, the device will not emit any hepatocellular carcinoma-modulation frequencies and will be activated for more than 200 one-hour treatment sessions.
15790879|NCT04526067|Behavioral|CAT|An evidence-based psychosocial treatment using environmental supports such as signs, alarms, pill containers, and the organization of belongings established in a person's home on weekly visits to cue adaptive behaviors and establish healthy habits.
15790880|NCT04526067|Behavioral|R-CAT|An evidence-based psychosocial treatment using environmental supports such as signs, alarms, pill containers, and the organization of belongings established in a person's home using remote weekly visits to cue adaptive behaviors and establish healthy habits.
15790881|NCT04526054|Diagnostic Test|ENT exam|ENT examination of the nasal cavity: nasofibroscopy and anterior rhinoscopy.
15790882|NCT04526054|Diagnostic Test|Olfactometry|Olfactometry test using odorous pens (Sniffin's stick test).
15790883|NCT04526054|Diagnostic Test|Brain MRI|Brain MRI focused on the olfactory bulbs (3 teslas).
15790884|NCT04526041|Other|Nasofibroscopy|Laryngeal exploration performed using a flexible fibrescope while singing.
15790885|NCT04526041|Other|Electroglottography|Electrography of glottal movement using the EG2-PCX2 system (Glottal enterprises) while singing.
15790886|NCT04526041|Other|Air flow measurement + acoustic signal recording|Air flow measurement and acoustic signal recording while singing using the EVA2 system (SQLab-LPL, Aix en Provence, France)
15790887|NCT04526041|Other|Questionnaire|Questionnaire on subject singing habits, the way it use and perceive the use of his body when singing.
15790888|NCT04526028|Drug|Fulvestrant Injectable Product|Fulvestrant is in the form of a prefilled syringe containing 5 ml of an injection solution of 250 mg of fulvestrant for intramuscular injection. The recommended dose is once every 28 days, once at a dose of 500 mg, and on the 15th day after the initial injection, a loading dose of fulvestrant 500 mg is added.
15790889|NCT04526028|Drug|Palbociclib|Palbociclib is in the form of oral capsules, which are divided into three specifications: 75 mg, 100 mg and 125 mg. The recommended dose is 125 mg once daily for 21 days, followed by 7 days (3/1 dosage regimen), 28 Day is a treatment cycle.
15790928|NCT04525651|Device|Digital Acupuncture Manipulation Therapeutic Instrument|The device is based on the characteristics of traditional acupuncture manipulation of Shanghai School of Traditional Chinese Medicine, and absorbs the information of the techniques of famous experts, modulates the stimulation waveform of the electroacupuncture device by modulating the signal, and realizes the digitization of acupuncture technique information.
15790890|NCT04526015|Procedure|Iliohypogastric and ilioinguinal nerve block|Each patient will receive spinal anesthesia plus bilateral ultrasound-guided IL/IH nerve block. The abdomen will be scanned through anterior superior iliac spine (ASIS)-umbilicus line. Ilioinguinal nerve can be visualized between the internal oblique and transverse or external oblique muscles and within 1 to 3 cm from the ASIS. The iliohypogastric nerve lies immediately adjacent. After negative aspiration (to exclude intravascular injection), 10 mL of 0.25% bupivacaine will be injected. The same technique will be performed on the other side
15790891|NCT04526015|Procedure|Controlled Group|Each patient will receive spinal anesthesia alone with no block.
15790892|NCT04526002|Device|Theta-burst stimulation (TBS)|TBS comprises 3-pulse 50-Hz bursts, applied every 200 ms (at 5 Hz) as described previously (Huang, Edwards et al. 2005). iTBS consists of 2-second trains with an inter-train-interval of 8 seconds. We will repeat trains (30 pulses; 10 bursts) for 20 times to reach a total number of 600 pulses (3x10x20). cTBS will comprise uninterrupted bursts to reach a total number of 600 pulses, as done routinely by others. Concurrent TBS/fNIRS stimulation will be applied over the left (iTBS) and right (cTBS) DLPFC at an intensity of 70-120%* resting motor threshold (RMT) (The ideal %RMT will be determined first in a pilot study). In part two, stimulation intensity for patients will be 120% RMT (titration to full therapeutic dose over the first three days), as approved by the FDA in the U.S. (Blumbeger et al. 2018). The stimulation site will be the same as in the concurrent TBS/fNIRS stimulation (see above).
15790893|NCT04525989|Radiation|Radiation therapy|5 x 5 Gy external radiation therapy
15790894|NCT04525963|Other|Preoperative visit of the operating room nurse and patient education|The operating room nurse, who is given intervention training, will visit the patient before the operation. After the oral training of the operating room nurse, a printed booklet will be left for the patient to read.
15790895|NCT04525950|Procedure|Navio|New generation computer navigation with haptics and robotics
15790896|NCT04525950|Procedure|Conventional|Total knee arthroplasty using conventional instruments
15790897|NCT04525937|Other|Patient Questionnaire|Patient Questionnaire
15790898|NCT04525937|Other|Provider Questionnaire|Provider Questionnaire
15790899|NCT04525924|Device|bright light therapy|please see arm description
15790900|NCT04525911|Diagnostic Test|Diagnostic Test: serology test for COVID-19|a serology test will be performed at M3
15790901|NCT04525898|Drug|Methadone|The methadone group will receive an intravenous dose of methadone at induction of anesthesia (0.15 mg/kg ideal body weight (IBW)
15790902|NCT04525885|Drug|Gefapixant 45 mg twice daily (BID)|Gefapixant 45 mg tablet to be administered orally BID
15790903|NCT04525885|Drug|Gefapixant 15 mg BID|Gefapixant 15 mg tablet to be administered orally BID
15790904|NCT04525885|Drug|Placebo|Placebo tablet administered orally BID
15790905|NCT04525872|Other|Full parenteral nutrition light protection of the bag, tubing and lipids|Each infant enrolled in this study will receive full PN light protection including the PN bag, lipids and tubing.
15790906|NCT04525859|Biological|Safety|See previous Safety group description
15790907|NCT04525859|Biological|Expansion Cohort|See previous Expansion Cohort
15790908|NCT04525846|Other|PFMT|"program of PFMT consist of contract and hold pelvic floor muscle 10 seconds and relax 10 seconds 20 times per set totally 3 set per day
~follow up by telephone once a week about compliance of program PFMT, general symptoms, notice recording book
~at third trimester evaluate UI by questionaire (UDI-6, IIQ-7)"
15790909|NCT04525846|Other|non PFMT|Randomized to non PFMT group follow up and evaluate UI at third trimester sames as intervention group
15790910|NCT04525820|Drug|Single high dose vitamin D|Patient receives either one dose orally of 140'000 IU (7 ml) of this drug once as an intervention treatment additionally to TAU or the patient receives 7 ml of the placebo Solution (7 ml) in addition to TAU
15790911|NCT04525820|Drug|Placebo|Patient receives a single dose of a placebo solution
15790912|NCT04525820|Drug|Treatment as usual vitamin D|Both groups receive the treatment as usual after the single high dose or the placebo which will be 800 IU per day
15790913|NCT04525807|Diagnostic Test|Multi-omics|Use multi-omics to analyze
15790914|NCT04525794|Device|BRight DCB|The BRight Drug-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon catheter (BRight DCB) is intended for dilatation of de novo lesions in native superficial femoral or popliteal arteries with a simultaneous release of drug to the vessel wall as a secondary action to reduce occurrence of a restenosis of the treated vessel segment.
15790915|NCT04525768|Diagnostic Test|JAK2 mutation test|Patients with portal caver cavernoma will be divided into two groups by the result of JAK2 mutation test
15790916|NCT04525755|Drug|Varenicline 0.5 MG|varenicline comes in bottles of 56 - 0.5 mg pills
15790917|NCT04525755|Drug|Nicotine Replacement Therapy (NRT)|28 day supply of nicotine patch (1 patch x 28 days @ 14 mg) and lozenge (14 per day x 28 days @ 4 mg)
15790918|NCT04525742|Other|Difficulties lived by disabled children's parents in the period of COVID-19 pandemic|It will be a cross sectional study to obtain the information on difficulties lived by disabled children's parents during recent pandemic period
15790919|NCT04525729|Drug|Rituximab|To evaluate the efficacy and safety of HLX01 combined with RASi in patients with IgAN.
15790920|NCT04525729|Drug|RAS 2410|To evaluate the efficacy and safety of RASi in patients with IgAN.
15790921|NCT04525716|Other|COVID-19 infection status|We will compare patients with/without confirmed COVID-19 infection
15790922|NCT04525703|Behavioral|Pathways for Parents after Incarceration|The Pathways for Parents after Incarceration program uses eight key lessons, including topics on effective listening, speaking, and problem-solving skills, lessons on emotion regulation, and issues surrounding family engagement. The program (both classroom and therapeutic peer support) will be offered virtually and weekly for 8 continuous weeks.
15790923|NCT04525690|Behavioral|Nudge|Clinicians will receive a default order upon entering the the admission order set. They will have the opportunity to opt-out and not order screening. Clinicians will receive the nudge each time they enter the admission order set for a new, eligible patient.
15790924|NCT04525664|Drug|Clarithromycin 500mg|500 mg per os twice daily for 14 consecutive days.
15790925|NCT04525664|Drug|Amoxicillin 1000 MG|1000 mg per os twice daily for 14 consecutive days.
15790926|NCT04525664|Drug|Omeprazole 40 MG|40 mg per os twice daily for 14 consecutive days.
15790927|NCT04525664|Drug|Omeprazole 20 MG Oral Tablet|20 mg per os daily for 1 month; only for patients with chronic dyspepsia and who are negative for Helicobacter pylori.
15790932|NCT04525638|Drug|Nivolumab|240 mg flat dose of nivolumab intravenously as a 30-minutes infusion
15790933|NCT04525612|Diagnostic Test|68Ga-BNU-PSMA|Each patient receive a single intravenous injection of 68Ga-BNU-PSMA, and undergo PET/CT scan within specified time.
15790936|NCT04525573|Device|LLLT Combination Red/Gold/IR Therapy|Three LLLT combination treatments per week over the course of two consecutive weeks, and a final follow up on day-15 (total of 7 treatments).
15790937|NCT04525560|Other|PEG-ELS-S|2/3 dose of PEG-ELS was taken orally from the evening on the day before colonoscopy, and the remaining 1/3 dose of PEG-ELS was orally administered in the morning of the next day.
15790938|NCT04525560|Other|PEG-ELS-L|PEG-ELS is given orally on the day before colonoscopy, which is divided into 10-12 portions and taken one portion every hour. If half of the total amount is not completed at afternoon ward round the day before colonoscopy, nasogastric feeding is recommended.
15790940|NCT04525521|Other|Hand sanitizer and hand washing|All subjects will cleanse their hands with hand sanitizer, followed by hand washing with soap and water
15790941|NCT04525495|Drug|Dopamine|Dopamine treatment
15790942|NCT04525482|Other|Early goal-directed sedation programs|A. Provide sedation at the beginning of the titration of dextrometomidine; b. Optimize sedation when dextrometomidine is used alone and at a maximum dose not sufficient to provide comfort and safety to the patient and to achieve a level of sedation at any time specified by the treating physician. C. Provides immediate recovery and sedation, and can control sudden agitation at any time
15790943|NCT04525469|Behavioral|Narrative Exposure Therapy|"NET involves: 1) diagnostic interview and psychoeducation, 2) laying out the Lifeline, 3) NET therapy sessions (constructing the trauma narrative in context of the life course), 4) final session rituals. Laying out the Lifeline (using rope or string) allows participants to take a bird's eye view of the events of their life using simple items such as flowers to represent positive events and stones to represent traumatic events. The focus of NET sessions is to encourage participants to describe the details of traumas and integrating the cold memories (i.e., facts) with the hot memories (e.g., cognitions, emotions, physiological feelings, and sensory information). The therapist makes notes after each session narrating the details of the traumas (stones) and reads this at the beginning of each subsequent session. Final session rituals involve re-reading the trauma narrative, hopes for the future, and laying out the final Lifeline placing flowers for hopes and wishes for the future."
15790944|NCT04525456|Dietary Supplement|Reduxium|Single-centre, one-arm, prospective study of 20 healthy subjects who will be given Reduxium supplementation for 14 days.
15790945|NCT04525430|Other|childbirth education|"The 1st Session: General information about labor: Factors affecting labor, early signs of labor, signs of the start of labor, steps of labor, and procedures applied during labor.
~The 2nd Session: Methods of coping with birth contractions: Breathing exercises, relaxation exercises, massage, changing position, music, cold/warm application, focus, and walking."
15790946|NCT04525430|Other|childbirth education and was subjected to a birth plan|In the birth plan created by the researchers, the pregnant women considered the process from the start of labor to the end of labor and marked the expectation from and preferences about this process on the birth plan.
15790947|NCT04525417|Diagnostic Test|AAZ Covid-19 rapid test|To assess the immune status
15790948|NCT04525404|Diagnostic Test|MRI (heart, brain, lungs, liver)|MRI (heart, brain, lungs, liver)
15790949|NCT04525404|Diagnostic Test|Bloodwork|Serum biomarkers to assess systemic inflammation, renal function, cardiac injury, liver injury and steatosis, ACE-2 related peptides, cytokines, Activin A and autoantibodies to cardiac antigens, humoral cell RNA
15790950|NCT04525404|Other|Cognitive testing|NIH toolbox Cognitive Measures
15790951|NCT04525404|Other|Olfaction testing|Brief Smell Identification Test (BSIT)
15790952|NCT04525404|Diagnostic Test|Spirometry|Spirometry to evaluate forced expiratory volume in 1 second and forced vital capacity
15790953|NCT04525404|Other|Walk Test|Walk test to record overall distance walked in 6 minutes and time taken to walk the first 25 feet
15790954|NCT04525391|Drug|Durvalumab+AZD2811 to SCLC patients|AZD2811 must NOT be infused through a 0.2-µm or 0.22-µm filter and therefore durvalumab and AZD2811 MUST be infused through different infusion lines. In order not to exceed the endotoxin limit, durvalumab and AZD2811 mustbe administered consecutively. Durvalumab is administered first over 1 hour, followed by AZD2811 administered over 2 hours. AZD2811 should be administered at 30 minutes after the end of the durvalumab infusion, as long as there are no acute infusion reactions to durvalumab.
15790955|NCT04525378|Other|Mesenchymal stromal cell-based therapy|Intravenous administration of MSCs, performed as single dose (high dose group) or repeated after 48 h (low doses; intermediate dose)
15790956|NCT04525365|Procedure|Pleural aspiration|Pleural aspiration
15790957|NCT04525352|Biological|RP-L401|CD34+ enriched hematopoietic stem cells from pediatric subjects with infantile malignant osteopetrosis transduced ex vivo with lentiviral vector carrying the TCIRG1 transgene
15790958|NCT04525339|Procedure|TAVI and Off pump CABG|Concomitant Transcatheter aortic valve implanatation and off pump coronary artery bypass grafting
15790959|NCT04525326|Drug|Cetuximab|mFOLFOX+Cetuximab for Ras / BRAF Wild Type Unresectable Right Colon Cancer Patients With Liver Metastasis
15790960|NCT04525326|Drug|Bevacizumab|mFOLFOX+Bevacizumab for Ras / BRAF Wild Type Unresectable Right Colon Cancer Patients With Liver Metastasis
15790961|NCT04525326|Drug|mFOLFOX/FOLFIRI ( Standard Chemotherapy)|Standard Chemotherapy
15790962|NCT04525300|Drug|Liraglutide|Randomization was performed with the use of a computer-generated system provided by the sponsor. Eligible patients were randomly assigned, in a 2:1 ratio, to receive once-daily subcutaneous injections of liraglutide, starting at a dose of 0.6 mg with weekly 0.6-mg increments to 3.0 mg, or placebo; both groups received counseling on lifestyle modification
15790963|NCT04525300|Drug|placebo|Randomization was performed with the use of a computer-generated system provided by the sponsor. Eligible patients were randomly assigned, in a 2:1 ratio, to receive once-daily subcutaneous injections of liraglutide, starting at a dose of 0.6 mg with weekly 0.6-mg increments to 3.0 mg, or placebo; both groups received counseling on lifestyle modification
15790997|NCT04525014|Drug|Temozolomide|100 mg/m2 (children ≥0.5 m2) or 3 mg/kg (children <0.5 m2) daily for 5 days beginning on day 1 of each cycle
15790964|NCT04525274|Drug|normal saline|"At the end of surgery, patient will be shifted to Trendelenburg position and intraperitoneal instillation of 40 ml bupivacaine 0.25% + 5 ml normal saline will be done guided by the camera and sprayed uniformly into the peritoneal cavity by the surgeon.
~The patient will be maintained in Trendelenburg position for 5-10 minutes after drug instillation and the abdomen will be deflated by passive exsufflation using gentle abdominal pressure."
15790965|NCT04525274|Drug|dexmedetomidine|"At the end of surgery, patient will be shifted to Trendelenburg position and intraperitoneal instillation of the study drug(40 ml bupivacaine 0.25% + 1 µg/kg dexmedetomidine diluted in 5 ml normal saline) will be done guided by the camera and sprayed uniformly into the peritoneal cavity by the surgeon.
~The patient will be maintained in Trendelenburg position for 5-10 minutes after drug instillation and the abdomen will be deflated by passive exsufflation using gentle abdominal pressure."
15790966|NCT04525274|Drug|Ketamine|"At the end of surgery, patient will be shifted to Trendelenburg position and intraperitoneal instillation of the study drug(40 ml bupivacaine 0.25% + 0.5 mg/kg ketamine diluted in 5 ml normal saline) will be done guided by the camera and sprayed uniformly into the peritoneal cavity by the surgeon.
~The patient will be maintained in Trendelenburg position for 5-10 minutes after drug instillation and the abdomen will be deflated by passive exsufflation using gentle abdominal pressure."
15790967|NCT04525248|Procedure|Laparoscopic total colectomy + low resection of rectum|Laparoscopic total colectomy + low resection of rectum
15790968|NCT04525248|Procedure|Laparoscopic total colectomy + High resection of rectum|Laparoscopic total colectomy + High resection of rectum
15790969|NCT04525235|Combination Product|phenotyping cocktail|A single dose of a cocktail of phenotyping probe drugs (caffeine, tolbutamide, omeprazole, dextromethorphan, midazolam and digoxin) will be administered together with standard dose rifampicin and 40 mg/kg rifampicin, respectively. Blood samples will be taken to assess phenotyping metrics of the cocktail agents and rifampicin pharmacokinetic parameters. The effect of high and standard dose rifampicin on the phenotyping metrics of the cocktail agents will be compared by using the bioequivalence approach
15790970|NCT04525235|Drug|rifampicin|A single dose of a cocktail of phenotyping probe drugs (caffeine, tolbutamide, omeprazole, dextromethorphan, midazolam and digoxin) will be administered together with standard dose rifampicin and 40 mg/kg rifampicin, respectively. Blood samples will be taken to assess phenotyping metrics of the cocktail agents and rifampicin pharmacokinetic parameters. The effect of high and standard dose rifampicin on the phenotyping metrics of the cocktail agents will be compared by using the bioequivalence approach
15790971|NCT04525222|Other|Health Promotion and Education|Receive motivational messages and smoking cessation information via text messages
15790972|NCT04525222|Behavioral|Smoking Cessation Intervention (Actify app)|Use Actify app
15790973|NCT04525222|Behavioral|Smoking Cessation Intervention (Current Standard Care app)|Use (USCPG) Current Standard Care app
15790974|NCT04525222|Other|Survey Administration|Ancillary studies
15790975|NCT04525209|Other|No intervention|No intervention
15790976|NCT04525196|Other|Physical activity.|"The procedure under study (physical activity program) will include, each week for 12 months, two sessions dedicated to the development of aerobic capacity and a muscle building session.
~The experimental group will therefore be offered 3 sessions of Physical Activity (PA) per week. The PA will be positioned in the first two hours after the start of the dialysis session. Each session will include 5 minutes of general warm-up, then 15 minutes of PA itself and finally 5 minutes of cool down period. The PA time itself will be increased as the sessions progress, according to the progress and improvement of physical capabilities of patients."
15790977|NCT04525183|Behavioral|Enhanced Usual Care (EOC)|Educational materials
15790978|NCT04525183|Behavioral|REVITALIZE ACT Intervention|Six 60-75 minute telehealth sessions approximately once a week for 6-8 weeks
15790979|NCT04525170|Device|HPT treatment|
15790980|NCT04525170|Device|untreated|
15790981|NCT04525157|Drug|Afamelanotide|
15790982|NCT04525157|Drug|Placebo|
15790983|NCT04525144|Drug|Tebonin Forte|Dietary supplement: Gingko biloba EGb 761
15790984|NCT04525131|Drug|CPX-POM|CPX-POM
15790985|NCT04525105|Genetic|SMAD2|a family of structurally related cytokines
15790986|NCT04525092|Device|Online Pre-dilution Hemodiafiltration|The following parameters: maximum Blood flow rate allowed by vascular access, dialyste rate of 500 mL/min and average convective volume of >44L/session reinjected in pre-dilution mode. The dialysate composition, net ultrafiltration rate and use of anticoagulation will be prescribed according to participant's characteristics.
15790987|NCT04525092|Device|Conventional Hemodialysis|Using the following parameters: maximum Blood flow rate allowed by vascular access, dialysate rate of 500 mL/min, no convection. The dialysate composition, net ultrafiltration rate and use of anticoagulation will be prescribed according to participant's characteristics.
15790988|NCT04525092|Device|Online Post-dilution Hemodiafiltration|The following parameters: maximum Blood flow rate allowed by vascular access, dialyste rate of 500 mL/min and average convective volume of >22L/session reinjected in pre-dilution mode. The dialysate composition and net ultrafiltration rate will be prescribed according to participant's characteristics. Usage of intra-dialysis anticoagulation is mandatory.
15790989|NCT04525079|Drug|CT-P59|CT-P59 will be administered
15790990|NCT04525079|Drug|Placebo|Placebo-matching CT-P59
15790991|NCT04525066|Drug|Hyaluronic acid|Patients in the treatment group received hyaluronic acid injection into the unaffected vocal cord intra-operatively during transoral laser microsurgery for early glottic cancer.
15790992|NCT04525066|Other|No Hyaluronic Acid Injection Injection|Patients in the placebo group did not receive hyaluronic acid injection into the unaffected vocal cord intra-operatively during transoral laser microsurgery for early glottic cancer.
15790993|NCT04525040|Dietary Supplement|ProbioKid®|Probiokid formulation includes three probiotic strains and fructooligosaccharides.
15790994|NCT04525040|Other|Pragmatic comparator|Standard of care as usual without a preventive intervention
15790995|NCT04525027|Diagnostic Test|intra-abdominal pressure in severe acute pancreatitis|daily intra abdominal pressures in patients admitted to ICU will be measured and noted for intial 5 days and followed up until end outcome
15790996|NCT04525014|Drug|RRx-001|RRx-001 will be administered every 3 weeks via intravenous infusion at three dose levels: 0.5 mg/m2 (Max 1 mg), 1 mg/m2 (Max 2 mg), and 2 mg/m2 (Max 4 mg).
15791105|NCT04524221|Drug|Placebo|Placebo taken twice daily in capsule form for 42 days
15790998|NCT04525014|Drug|Irinotecan|90 mg/m2 taken orally daily for 5 days administered 1 hour after temozolomide
15790999|NCT04524988|Procedure|Laparoscopic Simulation Training|All participants underwent 2.5h of training with one of two laparoscopic simulation trainers (FLS or EMIG).
15791000|NCT04524975|Drug|CD-008-0045|CD-008-0045 20 mg capsules
15791001|NCT04524975|Drug|Placebo|Placebo capsules
15791002|NCT04524962|Biological|Descartes 30|Mesenchymal Stem Cells or MSCs RNA-engineered to secrete a combination of DNases.
15791003|NCT04524949|Drug|IMCY-0098 450 μg|Small synthetic peptide for SC admin. Solvent: alum hydroxide
15791004|NCT04524949|Drug|IMCY-0098 1350 μg|Small synthetic peptide for SC admin. Solvent: alum hydroxide
15791005|NCT04524949|Drug|Placebo|Solvent: alum hydroxide
15791006|NCT04524936|Diagnostic Test|blood sample|
15791007|NCT04524923|Other|visual motor integration|investigate the relation between touch screen usage and visual motor integration in preschoolers
15791008|NCT04524923|Other|Quality of life assessment|investigate the relation between touch screen usage and Quality of life assessment in preschoolers
15791009|NCT04524923|Other|Cognitive Functioning|investigate the relation between touch screen usage and Cognitive Functioning assessment in preschoolers
15791010|NCT04524910|Drug|Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)|As prescribed by the treating physician
15791011|NCT04524897|Drug|Triamcinolone Injection in treatment of refractory benign Esophageal Stricture in children|Triamcinolone Injection in treatment of refractory benign Esophageal Stricture with endoscopic dilatation
15791012|NCT04524884|Drug|Surufatinib|Surufatinib is a tablet in the form of 50mg, oral, once a day.
15791013|NCT04524884|Drug|Toripalimab|Toripalimab is an injection in the form of 240mg, intravenous, once three weeks.
15791014|NCT04524871|Drug|Atezolizumab|Atezolizumab will be administered at a dose of 1200 mg by IV on Day 1 of each 21 day cycle.
15791015|NCT04524871|Drug|Bevacizumab|Bevacizumab will be administered at a dose of 15 mg/kg by IV infusion on Day 1 of each 21 day cycle.
15791016|NCT04524871|Drug|Tiragolumab|Tiragolumab will be administered at a dose of 600 mg by IV infusion on Day 1 of each 21 day cycle.
15791017|NCT04524871|Drug|Tocilizumab|Tocilizumab will be administered at a dose of 8 mg/kg by IV infusion on Day 1 of each 21 day cycle.
15791018|NCT04524871|Drug|SAR439459|SAR439459 will be administered at a dose of 22.5 mg/kg by IV infusion on Day 1 of each 21 day cycle.
15791019|NCT04524871|Drug|TPST-1120|TPST-1120 will be administered at a dose of 1200 mg by mouth on Days 1-21 of each 21 day cycle.
15791020|NCT04524871|Drug|RO7247669|RO7247669 will be administered at a dose of 2100 mg by IV infusion on Days 1 and 15 of each 28 day cycle.
15791021|NCT04524871|Drug|Bevacizumab|Bevacizumab will be administered at a dose of 10 mg/kg by IV infusion on Days 1 and 15 of each 28 day cycle.
15791022|NCT04524858|Drug|ATI-450|Oral, small molecule MK2 inhibitor
15791023|NCT04524845|Device|Unloading brace|"Participants underwent one session of gait analysis. The experimental protocol was divided in four conditions, the control condition without brace (NO), and then three conditions with the different braces tested in a randomized order.
~For each condition, the participant was fitted with the brace by the same experimenter and equipped with 19/20 retro-reflective markers (without/with brace) on the pelvis and the investigated leg for motion analysis. After a short recording in a fixed standing position (static trial), each participant carried out at least three barefoot walking trials of a few meters long at a self-selected pace. The walking trial was validated if a complete gait cycle occurred on the two 90cm x 90 cm force plates recording the ground reaction forces. After each condition, the participant had to assess knee pain."
15791024|NCT04524845|Device|Rebel Reliever (RR)|Rebel Reliever (RR) (Thuasne, Levallois Perret, France)
15791025|NCT04524845|Device|Action Reliever|Action Reliever (AR) (Thuasne, Levallois Perret, France)
15791026|NCT04524832|Drug|Oral semaglutide|Participants will receive once daily semaglutide tablets (oral administration) in a dose escalating manner for 16 weeks
15791027|NCT04524806|Other|stabilization splint|Stabilization splint is an appliance which applied to upper or lower jaw and regulating the occlusal forces in the temporomandibular joint that can cause disorders, also preventing excessive contraction of the masticatory muscles
15791028|NCT04524793|Other|Questionnaires|Questionnaires to assess the quality of life (EQ-5D, CVVQ, CIVIQ, AVVQ, Patient satisfaction survey)
15791029|NCT04524793|Other|Physical examinations|GSV/SSV/AASV reflux, CEAP Classification (Clinical, Aetiological, Anatomical and Pathophysiology), Venous Clinical Severity Score (VCSS) and duplex ultrasound
15791030|NCT04524780|Device|intracardiac echocardiography|30 patients use intracardiac echocardiography to guide left atrial appendage occluder device, 30 patients use radiography to guide left atrial appendage occluder device.
15791031|NCT04524767|Behavioral|SBIRT|Screening Brief Intervention and Referral to Treatment (SBIRT) is an evidence-based approach designed to provide screening, brief intervention, and referral to more intensive treatment for people at risk of developing mental disorders, including depression. SBIRT is composed of three core components: screening with a validated instrument, brief intervention, referral to treatment. Motivational Interviewing (MI) is the brief intervention most commonly used in SBIRT. MI is an empirically tested, person-centered, behavior change intervention designed to guide, elicit, and strengthen motivation for change. Subjects enrolled in the experimental SBIRT arm will receive up to a maximum of six sessions of MI.
15791032|NCT04524767|Behavioral|Referral as Usual|We will utilize depression educational brochures describing the nine hallmark symptoms of depression symptoms and the importance of seeking treatment from pamphlets from the National Institute of Mental Health (NIMH). Subjects will also receive a list of referral sites in the study's catchment area of Upper Manhattan
15791033|NCT04524741|Device|intracardiac echocardiography|30 patients use intracardiac echocardiography to guide left atrial appendage occluder device, 30 patients use radiography to guide left atrial appendage occluder device.
15791034|NCT04524728|Drug|Palbociclib|tablets
15791035|NCT04524728|Drug|Letrozole 2.5mg|tablets
15791036|NCT04524728|Drug|Fulvestrant|intramuscolar injections
15791037|NCT04524715|Device|Non-invasive red LLLT treatment to chest of patient.|Expose patient to LLLT light while lying on their back, elevated at an angle of approximately 45 degrees from horizontal. Position light over the patient's chest at a 33-degree bias to their right and left sides for 20 minutes each side respectively.
15791038|NCT04524715|Device|Sham Device Treatment|Expose patient to sham device while lying on their back, elevated at an angle of approximately 45 degrees from horizontal. Position light over the patient's chest at a 33-degree bias to their right and left sides for 20 minutes each side respectively.
15791039|NCT04524702|Drug|Gemcitabine|Given IV
15791040|NCT04524702|Drug|Hydroxychloroquine|Given PO
15791041|NCT04524702|Drug|Nab-paclitaxel|Given IV
15791042|NCT04524702|Drug|Paricalcitol|Given IV
15791047|NCT04524676|Procedure|Individualized Treatment|Patients under evaluation including hepatic venous pressure gradient (HVPG) and contrast-enhanced computed tomography of portal venous. For those patients with a HVPG ≥12mmHg or with extraluminal para-gastric vein will under transjugular intrahepatic portosystemic shunt and others receive endoscopic treatment.
15791048|NCT04524663|Drug|Camostat Mesilate|Camostat Mesilate administered as oral tablets
15791049|NCT04524663|Drug|Placebo|Placebo to match camostat mesilate
15791050|NCT04524663|Other|Standard of Care Treatment|Standard of Care Treatment for COVID-19 Infection
15791051|NCT04524650|Diagnostic Test|the level of vWF|the peripheral level of vWF
15791052|NCT04524624|Device|AI-based CDSS|"Automatically identifying acute ischemic stroke lesions on DWI.
~Classification of stroke subtypes and mechanisms.
~Evidence-based alerts and guidelines for early stroke management.
~Guideline-recommended secondary stroke prevention strategies."
15791057|NCT04524598|Device|Limbix Spark|The Limbix Spark program is divided into 5 levels. Each level provides educational information about cognitive behavioral therapy and interactive activities.
15791058|NCT04524598|Other|Psychoeducation|The Psychoeducation program is divided into 5 lessons. Each lesson covers a different topic about depression.
15791059|NCT04524585|Drug|Neuromuscular blockade|Cisatracurium will be infused to achieve esophageal pressure targets and maintain a Riker Sedation-Agitation Scale (SAS) score of 1-2. Additional boluses of cisatracurium will be delivered as required and adjustment of continuous infusion rate. After establishing a sedation and NMB strategy at which safe spontaneous breathing is achieved, we will seek to determine whether these targets can be maintained over a 24-hour period.
15791060|NCT04524572|Behavioral|Motion sensor|To explore the role of a motion sensor with accompanying web application on step counts, energy balance, and metabolic markers in nurses
15791061|NCT04524559|Other|conventional physical therapy training|"The program focused on regaining typical movement, prohibiting abnormal muscle tone, promoting postural reactions and enhancing postural mechanisms. The program was applied via certified physical therapists five days/week for 4 successive months. The intended goals of the treatment program were achieved through:
~Neurodevelopmental based training (NDT)
~Functional stretching exercises to preserve muscle and soft tissues elasticity
~Sequenced trunk co-activation (STA) exercises
~Righting and protective reactions It is worth mentioned that the exercises applied in each session was influenced by the age and the specific functional abilities within the selected activity."
15791062|NCT04524559|Other|oral motor training.|"Children in the experimental group received 30 minutes of oral motor training five days week. The training included oral stimulation (facilitation) conducted before the child's actual meal time.
~The designed protocol comprised modified perioral and intraoral maneuvers based on Fucile's protocol. The utmost aims of the protocol were to decrease hypersensitivity of oral structures, increase jaws movement, and reinforce muscle strength, improve tongue movement and enhance oral motor organization"
15791063|NCT04524546|Diagnostic Test|Sterno-mental displacement test|While the patient is in sitting position, (SMD neutral) will be is measured using tape as the distance between upper borders of the manubrium sterni to the mentum with the head in a neutral position. The (SMD extension) will be then measured in the same way with the head extended on the neck. The difference between SMD extension and SMD neutral will be then calculated as sternomental displacement (SMDD).
15791064|NCT04524533|Behavioral|Experimental smoking cessation video|Participants who are randomized to the intervention group will watch an educational video that includes tips on quitting smoking during a dental cleaning. The video is approximately 10 minutes long and tailored to readiness to quit at the time of the dental visit.
15791065|NCT04524533|Behavioral|Control video|Participants randomized to the control group will watch a 10 minute video.
15791066|NCT04524533|Other|Brochure of smoking cessation EBTs|All participants will receive identical print materials on EBTs consistent with smoking cessation standard clinical care.
15791067|NCT04524533|Behavioral|Tailored text message program|Participants randomized to the intervention group will be enrolled in a 4-week tailored text message program which includes assessment questions in addition to text messages geared towards motivating and facilitating EBT utilization for individuals ready to quit smoking and individuals who are not ready to quit smoking.
15791068|NCT04524533|Other|Assessment text messages|Participants randomized to the control group will be enrolled in a different 4-week text message program that includes only assessment questions.
15791069|NCT04524507|Biological|High-titer Convalescent COVID-19 Plasma (CCP1)|At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available.
15791070|NCT04524507|Biological|Standard-titer Convalescent COVID-19 plasma (CCP2)|At least two units of CCP transfused 4-24 hours apart on Study Day 0. A third unit may be administered, if available.
15791071|NCT04524494|Other|biopsy of intestinal tissue|4 intestinal tissue biopsies taken from descending Duodenum, 2 intestinal tissue biopsies taken from Ileum, 2 intestinal tissue biopsies taken from ascending colon (additional to routine biopsies taken for gastrointestinal diagnostic)
15791106|NCT04524208|Drug|Cabozantinib|Cabozantinib is administered orally at the dose of 60 mg per day..
15791072|NCT04524494|Other|blood draw|40 ml blood draw (in Heparin blood tubes) (additional to routine blood draw taken for gastrointestinal diagnostic)
15791073|NCT04524494|Other|urine collection|Midstream Urine collection
15791074|NCT04524468|Diagnostic Test|Transthoracic echocardiography|Conventional 2-D transthoracic echocardiography was performed to all patients
15791075|NCT04524455|Drug|Blinatumomab|Blinatumomab will be administered as a continuous intravenous infusion (cIV).
15791076|NCT04524455|Drug|AMG 404|AMG 404 will be administered as an intravenous infusion (IV).
15791077|NCT04524455|Drug|Dexamethasone Premedication|Dexamethasone will be administered orally or intravenously prior to blinatumomab treatment, as needed.
15791078|NCT04524442|Drug|arginine/lysine|1000 milliliters (mL) administered at a constant rate of 250 mL per hour
15791079|NCT04524429|Procedure|Bariatric Surgery|Bariatric surgery includes sleeve gastrectomy and gastric bypass.
15791080|NCT04524416|Device|Minimally invasive glaucoma surgery (MIGS)|MINIject implant placed into supraciliary space. The implantation was done in a previous study in which patient participated and is not part of this study.
15791081|NCT04524403|Drug|Miricorlilant|Miricorilant 600mg for oral dosing
15791082|NCT04524403|Drug|Miricorlilant|Miricorilant 900mg for oral dosing
15791083|NCT04524403|Drug|Miricorlilant|Placebo for oral dosing
15791084|NCT04524390|Drug|Maralixibat|A small molecule inhibitor of the ileal bile acid transporter (IBAT)
15791085|NCT04524390|Other|Placebo|Identical to maralixibat except for the active drug substance
15791086|NCT04524377|Procedure|Deep Brain Stimulation|"Deep brain stimulation involves implanting electrodes within certain areas of the brain. These electrodes produce electrical impulses that regulate abnormal impulses. Or the electrical impulses can affect certain cells and chemicals within the brain.
~The amount of stimulation in deep brain stimulation is controlled by a pacemaker-like device placed under the skin in the upper chest. A wire that travels under the skin connects this device to the electrodes in the brain."
15791087|NCT04524364|Device|Pulsed Field Ablation (PFA) Therapy|Participants will undergo PFA therapy with a compatible ablation catheter when used with Multi-Channel irreversible electroporation (IRE) Generator (deliver trains of high-voltage bipolar pulses of short duration on separate channels to a multi-electrode ablation catheter) and Circular IRE Catheter (indicated for use in catheter-based cardiac electrophysiological mapping (stimulating and recording) and, when used with an IRE Generator, for cardiac ablation).
15791088|NCT04524351|Drug|Posiphen|Solid oral dosage form, capsule
15791089|NCT04524338|Device|Transcranial Direct Current Stimulation|Brain Stimulation Devices attached to scalp
15791090|NCT04524325|Other|Trans men|We are studying the effects of testosterone taken by trans men on mechanisms of blood pressure control and comparing those results to cisgender women that have normal (ie lower) testosterone levels.
15791091|NCT04524312|Procedure|Total knee replacement|Participant will undergo total knee replacement performed via anterior parapatellar approach with either Posterior-stabilized or retaining cruciate-retaining with dynamic congruence implant
15791092|NCT04524312|Diagnostic Test|Biomechanics|Participants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively
15791093|NCT04524312|Device|NexGen Ps or Bioimplanti K-MOD implant|Participant are randomly allocated to receive one of the NexGen PS or Biomplanti K-MOD total knee implant for treatment of end-stage knee osteoarthritis.
15791094|NCT04524299|Radiation|chest radiation(IMRT)|Patients will receive intensity modulated radiotherapy (IMRT) once a day, 5 days a week. The first stage: DT 3000 cGy / 6 FX; the second stage, DT 3500 cGy / 7 FX. Or: the first segment: DT 4000 cGy / 10 FX; the second segment DT 2400 cGy / 6 FX. The interval between two stages of radiotherapy was 4 weeks.
15791095|NCT04524299|Drug|Concurrent chemotherapy twice a week|"During the same period of radiotherapy, 30 mg / m2 albumin bound paclitaxel was intravenously infused twice a week for 0.5 hours, and nedaplatin 10 mg / m2 twice a week for 0.5 hours.
~When the radiotherapy dose was 3000 cGy / 6 FX + DT 3500 cGy / 7 FX, the infusion time was D1, D4, D8 of the first stage of radiotherapy; D1, D4, D8 of the second stage of radiotherapy.
~When the radiotherapy dose was 4000 cGy / 10 FX + DT 2400 cGy / 6 FX, the infusion time was D1, D4, D8, D11 of the first stage of radiotherapy; D1, D4, D8 of the second stage of radiotherapy"
15791096|NCT04524299|Drug|Concurrent chemotherapy once a week|During the same period of radiotherapy, albumin bound paclitaxel (50 mg / m2) was intravenously infused once a week for 0.5 hours; nedaplatin (25 mg / m2) was intravenously infused once a week for 0.5 hours. The infusion time was D1, D8 of the first radiotherapy and D1, D8 of the second radiotherapy.
15791097|NCT04524286|Other|Interviews only.|Interviews will be conducted with childbearing women and midwives.
15791098|NCT04524273|Drug|inebilizumab|Participants will receive IV inebilizumab
15791099|NCT04524273|Drug|IV Placebo|Participants will receive IV placebo matched to inebilizumab
15791100|NCT04524260|Behavioral|perioperative painting art therapy (LOM® solution centered art therapy)|We plan to apply painting art therapy as a health-related intervention to patients coming to our department for elective major surgery of the pancreatic and lower gastrointestinal tract for malignant pathologies. Patients will have 3 patient art therapy sessions: one before surgery, one on day 3-5 after surgery during the hospital stay and one during the follow-up 6 weeks postoperative
15791101|NCT04524260|Behavioral|perioperative painting art therapy (LOM® solution centered art therapy) - control|"usual care, no particular intervention during the perioperative setting. There will be 2-3 painting art therapy sessions after the follow-up 6 weeks postoperative. Therefore this group is called usual care- or delayed intervention group."
15791102|NCT04524247|Device|Physician Modified Endografts|"Modification procedure Description of modified device is detailed in Section 3.5 of IDE. In summary, the steps involved in modification of the Zenith Alpha thoracic stent grafts are;
~Unsheathing of the stent graft
~Retrieval of a trigger wire from the inner cannula of the delivery system
~Rerouting of the trigger wire along the stent graft
~Removal of proximal barbs.
~Creation of fenestrations and/or branch cuffs
~Placement of radiopaque markers around the fenestrations/ branch cuffs
~Placement of temporary and/or permanent diameter constraining ties
~(Optional) Placement of preloaded wires through the fenestrations/branch cuffs"
15791103|NCT04524234|Diagnostic Test|Echocardiography|Echocardiography for assessment of cardiac function
15791104|NCT04524221|Drug|PTG-100|PTG-100, 600mg taken twice daily in capsule form for 42 days
15791107|NCT04524195|Drug|[18F]F-AraG Injection|Single dose of 5 mCi+/- [18F]F-AraG IV injection followed by the PET/CT scan. A baseline [18F]F-AraG PET/CT will be performed at about 0-7 days before patient receives the first dose of PD-1/PD-L1 immunotherapy. A second [18F]F-AraG PET-CT will be performed at less than 14 days after the first dose of PD-1/PD-L1 immunotherapy is administered and before the second dose of PD-1/PD-L1 immunotherapy is given.
15791110|NCT04524169|Drug|Thymosin Alpha1|Thymosin Alpha 1 will be subcutaneous injected to the participants twice per week for 4 weeks.
15791111|NCT04524156|Other|Physiology|"Percutaneous O2 and CO2 partial pressures. A PeriFlux system 5000 (Perimed©, Järfälla, Sweden) will be used to monitor TcpO2 and TcpCO2 tensions by means of a PF 5040 unit and a dual TcpO2/CO2 E5280 electrode. The E5280 electrode, covered by a membrane permeable to oxygen (O2) and carbon dioxide (CO2) heats (44°C) the underlying tissue to maximize gas diffusion through the skin. .
~Pulse Oximeter and hemodynamic parameters Pulse oximeter is a portable device largely used to measure real time finger oxygen saturation (SatO2) and heart rate Blood collection After the above said measurements, a venous blood simple will be realized. Plasma concentration of ACE2, Angiotensin II, Angiotensin 1-7, angiotensin 1-9, CC16, will be measured at the Erasme hospital (ELISA method)."
15791114|NCT04524130|Drug|Lidocaine Hydrochloride|lidocaine will be given 1.5 mg/kg bolus at induction then 2mg/kg/hr until the end of surgery.
15791115|NCT04524130|Drug|Ketamine|Ketamine will be given 0.35 mg/kg bolus at induction then 0.2 mg/kg/hr until the end of surgery.
15791116|NCT04524130|Drug|Placebo|Normal saline will be given with the same rate of lidocaine or ketamine.
15791117|NCT04524104|Behavioral|Lumen Treatment|the virtual AI agent, Lumen, via an iPad-based application. Each participant will receive a locked, encrypted study iPad installed with Lumen. They will complete 8 problem solving therapy (PST) sessions beginning with 4 weekly and then 4 biweekly intervals over 12 weeks on their assigned iPad.
15791118|NCT04524091|Other|Positive end expiratory pressure|Initially, the patients will be ventilated using pressure support ventilation with an inspiratory pressure adjusted to achieve 6 - 8 ml/kg of PBW with a minimal esophageal pressure swing of 5 cmH2O and a PEEP of 5 cmH2O. After 5 minutes, we will measure five IPSexp and five IPSinsp in random order and considering a resting period between each occlusion in order to avoid learning effect and disconfort. The IR will be calculated using the average of the measured IPSexp and the average of the IPSinsp. Besides, we will register the average of esophageal pressure and transpulmonary pressure swings continuously. The same procedure will be carried out with 10 and 15 cmH2O of PEEP. Inspiratory pressure will be kept constant throughout the protocol.
15791119|NCT04524078|Other|intensive integrated intervention care program|intensive integrated intervention care program [ICP] (lifestyle changes, patient education, adherence to practical guidelines) to transient ischemic attack or minor stroke patients would modify a variety of vascular risk factors and therefore should decrease the likelihood of recurrent stroke or vascular events
15791120|NCT04524065|Other|Early rehabilitation protocol for children hospitalized in the PICU|The early rehabilitation protocol was developed by a collaborative multidisciplinary team approach in Samsung Medical Center, and the central components include the involvement of physical therapy/occupational therapy (PT/OT).
15791121|NCT04524052|Drug|DWRX2003|Intramuscularly injection at pre-defined injection sites
15791122|NCT04524052|Drug|Placebo|Intramuscularly injection at pre-defined injection sites
15791123|NCT04524039|Device|intermittent theta burst stimulation using a MagPro X100|Patients randomized to receive iTBS in left dorsolateral prefrontal cortex, each treatment will consist of 600 stimuli (triplet 50 Hz bursts, repeated at 5 Hz; 2 s on and 8 s off; total duration of 3 min 12 s). Simulated iTBS will be administered using Magventure static cooling MCF-B65 coil.
15791124|NCT04524039|Device|sham intermittent theta burst stimulation using a MagPro X100|Patients randomized to receive sham iTBS will undergo the same procedure to patients receiving real iTBS. Sham iTBS will be administered using Magventure static cooling MCF-P-B65 coil that shares the same mechanical outline and produces identical sound level to MCF-B65 coil without stimulating the cerebral cortex.
15791125|NCT04524026|Drug|Letrozole 5 mg|recFSH and co-treatment with letrozole 5 mg/day from stimulation day 1 on cycle day 2 or 3 until the day before GnRH agonist administration to trigger final oocyte maturation. GnRH antagonist 0.25 mg/day from stimulation day 5 until day of GnRH agonist administration. No luteal phase support.
15791126|NCT04524013|Other|There is no intervention. It is an observational study.|There is not intervention
15791127|NCT04524000|Drug|Alpelisib|"[Part 1] Alpelisib administered at 200 mg (DL 1), 250 mg (DL 2) or 300mg (DL 3) orally once daily on a continuous dosing schedule starting on Cycle 1 Day 1 in a 28 day cycle.
~If DL 1 is tolerated, the alpelisib doses of 250 mg will be investigated. If DL 2 is tolerated, the alpelisib doses of 300 mg will be investigated.
~[Part 2] In the Part 2, participants will be enrolled into Cohort 2 (CDK4/6 inhibitor naive) and Cohort 3 (CDK4/6 inhibitor pre-treated) in parallel and alpelisib will be administered at the recommended dose identified in Part 1."
15791128|NCT04524000|Drug|Fulvestrant|Fulvestrant is administered at a dose of 500 mg intramuscular on Cycle 1 Day 1, Day 15, and Day 1 of every cycle thereafter (where a cycle is 28 days).
15791129|NCT04523987|Drug|Ciprofloxacin|Subjects enrolled will be administered oral ciprofloxacin twice a day throughout the course of each 28-day cycle of gemcitabine and nab-paclitaxel chemotherapy.
15791130|NCT04523974|Procedure|Preemptive Surgical Intervention and Precise Efficacy Evaluation of CKD-SHPT|"Preemptive surgical intervention for CKD-SHPT patients with poor calcium and phosphorus metabolism controlled by drugs;
~Rapid immunoreactive parathyroid hormone detection technology during peri-operative period."
15791131|NCT04523961|Drug|2.5 g of lidocaine 23% / tetracaine 7% ointment without occlusion|Topical anesthetic used to numb the skin prior to laser procedures
15791132|NCT04523961|Drug|7.5 g lidocaine 2.5%/ prilocaine 2.5% cream with occlusion|Topical anesthetic used to numb the skin prior to laser procedures
15791133|NCT04523948|Behavioral|Behavioral and pharmacological support to reduce combustible tobacco use.|Behavioral and pharmacological support to reduce combustible tobacco use.
15791136|NCT04523922|Drug|40 IU Intranasal Oxytocin|40 IU Intranasal Oxytocin self administered 30 minutes prior to each COPE session.
15791137|NCT04523922|Drug|Placebo|Placebo (intranasal saline spray) self administered 30 minutes prior to each COPE session.
15791138|NCT04523922|Behavioral|Concurrent Treatment of PTSD and Substance Use Disorders using Prolonged Exposure|12 weekly sessions of COPE therapy for PTSD and AUD.
15791139|NCT04523909|Diagnostic Test|Trajectory of neuroinflammatory proteins in CSF and blood|Kinetics of neuroinflammatory markers in CSF and blood
15791140|NCT04523896|Radiation|Real time High-Dose-Rate prostate brachytherapy in combination with stereotactic prostate radiotherapy|"- Brachytherapy: Real time HDR prostate brachytherapy using a MRI-trans-rectal ultrasound image fusion protocol: single fraction of 15 Gy.
~Planning software: Oncentra prostate (Nucletron)
~- External beam radiotherapy: Stereotactic ablative radiation therapy (SABR): 5 session in 5 consecutive days, 5 Gy per fraction to the prostate.
~Intra-fraction gold seeds monitoring using Auto beam Hold solution (Varian) Planning software: Eclipse (Varian)."
15791141|NCT04523883|Radiation|postoperative radiotherapy|postoperative radiotherapy with a dose of 60-66Gy
15791142|NCT04523883|Drug|JS001|JS001 240mg every three week
15791143|NCT04523870|Dietary Supplement|Botanical extract|One capsule
15791144|NCT04523870|Dietary Supplement|Main compound of the botanical extract|one capsule
15791145|NCT04523870|Dietary Supplement|Placebo|Maltodextrin, one capsule
15791146|NCT04523857|Drug|Abemaciclib|Oral CDK4/6 inhibitor to target bone marrow disseminated tumor cells (DTCs)
15791147|NCT04523857|Drug|Hydroxychloroquine|Oral autophagy inhibitor to target bone marrow disseminated tumor cells (DTCs)
15791148|NCT04523844|Drug|Brinzolamide-brimonidine Fixed Combination|In case group one drop of a fixed combination of brinzolamide-brimonidine will be instilled two hours before the injection
15791149|NCT04523831|Drug|Ivermectin and Doxycycline|Ivermectin 6 mg, 2 tab stat and Doxycycline 100 mg twice daily for 5 days
15791150|NCT04523831|Drug|Standard of care|Paracetamol, Vitamin D, Oxygen if indicated, Low molecular weight heparin, dexamethasone if indicated
15791151|NCT04523818|Drug|Capecitabine|Given PO
15791152|NCT04523818|Drug|Fluorouracil|Given IV
15791153|NCT04523818|Radiation|Radiation Therapy|Undergo radiation therapy
15791154|NCT04523818|Procedure|Therapeutic Surgical Procedure|Undergo standard of care surgery
15791155|NCT04523805|Behavioral|Adapted judo programme|"The judo sessions were 75 minutes in duration and were held once a week. Two judo teachers led each session, and at least four volunteer judo instructors were present to lend support. The sessions were divided into warm-up, main exercise and cool-down activities. The main exercise content of the sessions included:
~Different types of movements and falling techniques (from walking in all directions to turning around, from stable movements to unstable movements).
~Judo techniques and games (building up body contact with games, teaching simplified movements, essential judo movements) (blinded for review).
~Ground control techniques and throws (gradually adding techniques to already known movements, scaffolding basic repetitive movements to assist in understanding to those more relevant for judo ).
~Repetition of different forms of foundational directional movements (pulling, pushing, holding, lifting)."
15791156|NCT04523792|Drug|SUBLOCADE|SUBLOCADE (buprenorphine extended-release) injection is a colorless to amber sterile solution for SC injection designed to deliver buprenorphine at doses of 100 mg or 300 mg at a controlled rate over a one-month period.
15791157|NCT04523779|Behavioral|Brief Cognitive Behavioral Therapy|The proposed bCBT treatment for anxiety was specifically designed for use within VA PCMHI settings and uses a patient-centered approach to increase engagement while addressing the mental health needs of anxious Veterans. Emphasis was placed on maximizing intervention potency and minimizing intensity and duration to improve implementation value and alignment with VA PCMHI requirements. The intervention directly addresses challenges to delivery of CBT providing 1) a brief, practical model of care to address multiple anxiety conditions consistent with the PCMHI model (e.g. 4-6 sessions; measurement-based care), and 2) a clinically potent intervention that includes exposure-based skills.
15791158|NCT04523766|Behavioral|Mindfulness of Breath|The Mindful Breathing intervention will be adapted from a validated, brief mindfulness training model. Participants will be instructed to focus on the sensations of the breath (i.e., at the tip of the nose and in the nostrils, abdomen and back) and, if a pain arises in the body, acknowledge it without judgement and return attention to the breath.
15791159|NCT04523766|Behavioral|Mindful Interoceptive Mapping|The MIM intervention will be adapted from the core MORE meditation practice. Participants will be instructed to (1) zoom in to deconstruct pain into its constituent affectively-valenced physical sensations and precisely map each sensation's spatial location, (2) zoom out to broaden the field of attention to include previously neglected sensory elements (i.e., spaces within the body that are absent of sensation and pleasant sensations), and (3) savor any pleasant sensations or experiences occurring during the mindfulness practice.
15791160|NCT04523753|Procedure|emergency endoscopy|emergency endoscopy for gastrointestinal bleeding situation before or after surgery
15791161|NCT04523740|Drug|Placebo|Patients who use regular paracetamol will now receive 6 to 8 tablets of placebo per day for 2 weeks
15791162|NCT04523740|Drug|Paracetamol|Patients who use regular paracetamol will now receive 6 to 8 tablets of 500 mg paracetamol per day for 2 weeks
15791163|NCT04523727|Drug|ferric citrate|oral tablets
15791164|NCT04523714|Behavioral|Web-based CBT-CP|Interactive web-based mHealth program in which participants complete eight, approximately weekly sessions focused on training in one or more evidence-based pain coping skills.
15791165|NCT04523714|Behavioral|Virtual coach-led CBT-CP|Live, coach-led program delivered by telephone or videoconference consisting of eight, approximately weekly sessions focused on training in one or more evidence-based pain coping skills
15791166|NCT04523701|Drug|"white test (= the administration of SMOFlipid retrograde through the cystic duct)"|"white test (= the administration of SMOFlipid retrograde through the cystic duct)"
15791167|NCT04523688|Biological|Autologous Dendritic Cells (DC) vaccine|10×10exp6 autologous dendritic cells loaded with autologous tumour homogenate given by intradermal injection (day 1)
15791168|NCT04523688|Drug|Temozolomide|Adjuvant temozolomide assumed orally from day 1 to 5 (start on week 5). Dosage: 150mg/m2/day for the first cycle and 200 mg/m2/day for subsequent cycles (q28).
15791169|NCT04523675|Dietary Supplement|N-acetylcysteine|Orally in three daily dosages (morning-midday-evening), at 20 mg/kg/day, for seven consecutive days.
15791170|NCT04523675|Dietary Supplement|Placebo|500 mL drink that contained water (375 mL), sugar-free cordial (125 ml), and 2 g of low-calorie glucose/dextrose powder. Orally in three daily dosages (morning-midday-evening), for seven consecutive days.
15791171|NCT04523662|Drug|Camrelizumab Apatinib Mesylas|This study intends to use the PD-1 antibody carrelizumab combined with apatinib and radiotherapy to treat patients with advanced liver cancer with extrahepatic metastasis
15791172|NCT04523649|Device|Remote atrial fibrillation screening with handheld single lead ECG recorder|Patients in this group will be given a handheld single lead ECG recorder (Comfit Healthcare Devices Limited, Hong Kong SAR, China) and a patient-facing smartphone application specially designed for the study, and they will be requested to record daily ECG and certain vital measurement.
15791173|NCT04523636|Device|Splinting|Pre-fabricated or custom resting hand splints
15791174|NCT04523623|Drug|Oxycodone|oxycodone 0.2mg/kg, max 10mg to be administered, randomized between that and Ibuprofen
15791175|NCT04523623|Drug|Ibuprofen|ibuprofen 10mg/kg, max 800mg, randomized between that and Oxycodone
15791176|NCT04523610|Behavioral|Telehealth phone calls|The volunteer-based weekly Telehealth support primarily provides program users with friendly listening/conversation. Volunteers will also inquire about their general wellbeing, provide information about COVID-19, and ask if the older adult needs any help or support (e.g. food delivery, medication from their pharmacy).
15791177|NCT04523610|Other|Volunteer of TIP-OA Program|Participant is a volunteer of the TIP-OA Program
15791178|NCT04523610|Other|Stakeholder of TIP-OA Program|Participant is a stakeholder of the TIP-OA Program
15791179|NCT04523584|Device|Magnetic Resonance Imaging (MRI)|Participants will undergo MR imaging of the liver. Liver PDFF will be measured.
15791180|NCT04523584|Device|Ultrasound Imaging|Participants will undergo ultrasound imaging of the liver. UDFF and shear wave speed (US-SWS) will be measured.
15791181|NCT04523571|Biological|BNT162b1|Intramuscular injection
15791182|NCT04523571|Other|Placebo|Intramuscular injection
15791183|NCT04523558|Device|Implantation of LuxSmart hydrophobic IOLs (Bausch + Lomb) in both eyes|Extended depth of field intraocular lens made form hydrophobic material
15791184|NCT04523532|Other|Dietary folate and hazelnut oil|Intervention with folate-rich diet and hazelnut oil supplement in capsule
15791185|NCT04523519|Behavioral|Video directly observed therapy with contingency management|PrEP adherence will be assessed by visual recognition software during video capture and reviewed for confirmation by study staff, ensuring that videos demonstrate study medication dosing by participant. Participants will receive small financial incentives upon confirmation of dosing.
15791186|NCT04523519|Behavioral|Integrated Next-Step Counseling|Integrated Next-Step Counseling combines support for behavioral strategies that reduce sexual and injection-related HIV risk and do not involve PrEP, with strategies to support PrEP adherence in brief, client-centered conversations.
15791187|NCT04523506|Biological|Botulinum toxin(Botox)|This study will evaluate the use of botulinum toxin for reduced oral aperture in scleroderma patients. Botox is a neurotoxin that functions as a paralytic by preventing the release of acetylcholine to inhibit muscle contracture and decrease fibrosis by decreasing differentiation of fibroblasts to myofibroblasts, decreasing expression of collagen, and increasing expression of matrix metalloproteinase.
15791188|NCT04523493|Combination Product|Toripalimab combined with Lenvatinib|"Experimental group:
~Toripalimab, 240mg, IV infusion, every 3 weeks (q3w). combined with Lenvatinib 12 mg/day (Body Weight≥60 kg) or 8 mg/day (Body Weight<60 kg) oral administration, once daily. Continuous infusion, in a cycle of 3 weeks (21 days), until occurrence of termination event specified in the protocol."
15791189|NCT04523493|Combination Product|Placebo combined with Lanvatinib|"Control group:
~Placebo, one unit, IV infusion, once every 3 weeks, combined with Lenvatinib 12 mg/day (Body Weight≥60 kg) or 8 mg/day (Body Weight<60 kg) oral administration, once daily. Continuous infusion, in a cycle of 3 weeks (21 days), until occurrence of termination event specified in the protocol."
15791190|NCT04523480|Drug|Testopel|75 mg Testosterone pellets administered subcutaneously.
15791191|NCT04523480|Drug|Testosterone Pellet, 100Mg|100 mg Testosterone pellets administered subcutaneously.
15791192|NCT04523480|Drug|Testosterone Pellet, 200 Mg|200 mg Testosterone pellets administered subcutaneously.
15791193|NCT04523467|Drug|Anti-angiogenic Targeted Drugs|A tyrosine kinase inhibitor inhibits vascular endothelial growth factor (VEGF) receptors 1-3, showed efficacy in hepatocellular carcinoma
15791194|NCT04523467|Drug|Ginsenoside Rg3|An active ingredient extracted from ginseng leachate, which can restrain angiogenesis and reduce the expression of programmed cell death ligand 1 (PD-L1) on the tumor cell surface and block the binding of programmed cell death 1 (PD-1) and PD-L1
15791195|NCT04523467|Procedure|TACE|A specific type of chemoembolization that blocks the hepatic artery to treat liver cancer
15791196|NCT04523441|Other|Focus group|Holding of a focus group by a sociologist
15791197|NCT04523441|Other|Semi-directive interview|Conducting a semi-directive interview by a sociologist after discharge from hospital
15791198|NCT04523428|Drug|Venetoclax/Acalabrutinib|All patients will receive a lead-in with 2 cycles of acalabrutinib 100 mg bid. Hereafter patients will continue with ramp-up of venetoclax followed by daily 400 mg venetoclax in combination with acalabrutinib for 24 cycles. Patients will be treated until they have received a total of 26 cycles or until progression, whichever comes first.
15791199|NCT04523415|Other|without intervention, just retrospectively review the data about patients|without intervention
15791200|NCT04523402|Drug|Neoadjuvant chemotherapy|Neoadjuvant chemotherapy with GEMOX regimen before liver resection
15791201|NCT04523389|Biological|analysis (protein, lipid, RNA ...) of circulating exosomes, size and number|use of blood samples stored at the Ferdinand Cabanne Biological Resource Centre
15791202|NCT04523389|Other|Gathering additional information about the patient's cancer|Gathering additional information about the patient's cancer, its treatment and its sequelae from the patient's medical record.
15791203|NCT04523389|Diagnostic Test|Diagnostic test|Diagnostic test
15791204|NCT04523376|Device|CliniMACS|Peripheral blood stem cells from closely matched unrelated donors will be processed using the CliniMACS device to remove TCRalpha/beta T cells and B cells, in accordance with the Investigator Brochure and Technical Manual following the laboratory standard operating procedures (SOPs) and using aseptic technique
15791205|NCT04523363|Drug|Metformin|Maximum dosage of 500 mg tablets 2 times a day (with each meal)
15791206|NCT04523350|Device|Instylla HES|Instylla HES is a novel liquid embolic made of primarily water and polyethylene glycol (PEG)
15791207|NCT04523350|Other|TAE or cTACE|Bland TAE or cTACE
15791208|NCT04523337|Behavioral|Maintaining Maintaining Independence and Sobriety through Systems Integration Outreach and Networking- Criminal Justice|Maintaining Independence and Sobriety through Systems Integration Outreach and Networking- Criminal Justice version (MISSION-CJ) programming targets co-occurring substance use and mental health disorders and other related health outcomes faced by justice-involved homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based services. Patients will receive 2 hours of MISSION-CJ services per week during and after their stay in the mental health residential rehabilitation program (total of 6-months). Services are delivered using a Critical Time Intervention stepdown approach.
15791209|NCT04523337|Behavioral|Maintaining Maintaining Independence and Sobriety through Systems Integration Outreach and Networking Peer Support|The MISSION Peer Support Curriculum is rolling entry, and includes 24, one-hour exercises focused on co-occurring substance use and mental health disorders, recovery, and community integration.
15791210|NCT04523324|Biological|Flublok™ Quadrivalent by Sanofi, Inc.|0.5 mL intramuscular dose of Flublok
15791211|NCT04523324|Biological|VaxigripTetra™ by Sanofi, Inc.|0.5 mL intramuscular dose of Vaxigrip
15791212|NCT04523311|Behavioral|Hypnosis.|Online, group-based, single session hypnosis workshop followed by 2 weeks of self hypnosis.
15791213|NCT04523311|Other|Usual care|Participants will be asked to continue with whatever interventions they are already receiving/employing to manage their migraine and tension-type headaches.
15791214|NCT04523298|Procedure|Non-ablative vaginal Erbium YAG laser treatment|"There are 3 visits where vaginal application of laser will be performed, with a 4-weeks interval. If needed, 3 extra laser applications can be added to the treatment (ie. with a maximum of 6 applications). Each application lasts around 15 minutes. The vaginal laser procedure will be performed in an outpatient setting, not requiring any specific preparation, analgesia or anesthesia, by one of two experienced operators.
~Laser therapy is performed using a 2940 nm VEL (SP Spectro, Fotona, Slovenia(24)) with SMOOTH mode setting, which enables non-ablative, thermal-only operation(25). The parameters are selected based on extensive preclinical and clinical studies(26,27,28).
~Each laser treatment session consists of a full vaginal canal irradiation (using a 360° circular adapter), followed by additional irradiation of the prolapsed anterior wall (using a 90° angular adaptor) and concluded with irradiation of the vestibule area."
15791215|NCT04523298|Other|Pelvic floor exercises (PFE)|Standard PFE in Belgium are 9 sessions with a pelvic floor physiotherapist of choice, which can be extended by another 9 sessions, if clinically indicated. There are different strategies, though that will be on discretion of the physiotherapist. We will register the type of physiotherapy (standard (PFMT) versus assisted pelvic floor muscles training (APFMT)), number of completed sessions and duration of therapy. What is exactly done by the patient is registered as a variable.
15791216|NCT04523285|Drug|TQB3728|TQB3728 tablets is a small molecule oral drug.
15791217|NCT04523272|Drug|TQB2450|TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
15791218|NCT04523272|Drug|Anlotinib|A multi-target receptor tyrosine kinase inhibitor.
15791219|NCT04523272|Drug|Sunitinib|A multi-target receptor tyrosine kinase inhibitor.
15791220|NCT04523246|Biological|SHINGRIX (Zoster Vaccine REcombinant, Adjuvanted)|The Shingrix vaccine is a subunit vaccine that contains the recombinant varicella zoster virus (VZV) glycoprotein E (gE), adjuvanted with the proprietary Adjuvant System (AS01B). The AS01B Adjuvant system consists of two immune-stimulants, the saponin, Quillaja saponaria Molina, fraction 21 (QS21), and the TLR4 agonist, MPL (3-O-desacyl-40-MPL) that enhance the release of interferon gamma (IFNϒ), which in turn stimulates activation and recruitment of blood monocyte-derived and resident lymph node dendritic cells to take up and present gE to cluster of differentiation 4 (CD4+) T cells.
15791221|NCT04523246|Drug|Normal Saline|Sterile normal saline, inactive control.
15791222|NCT04523233|Diagnostic Test|Amniocentesis|Amniocentesis is a procedure in which amniotic fluid is removed from the uterus for testing or treatment.
15791223|NCT04523220|Drug|BAY1213790|Single loading dose as subcutaneous abdominal injection followed by monthly maintenance doses.
15791224|NCT04523220|Drug|Placebo|Subcutaneous administration in the same manner as Osocimab.
15791225|NCT04523207|Drug|Apalutamide|Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) oral tablets during the main study and sub-study.
15791226|NCT04523207|Drug|ADT|Participants will receive ADT intramuscular or subcutaneously during the main study.
15791227|NCT04523207|Drug|Relugolix|Participants will receive 120 mg of relugolix following a loading dose of 360 mg of (3 tablets of 120 mg each) relugolix during the sub-study.
15791228|NCT04523194|Other|Optical Coherence Tomography (OCT) and Computed Tomography Angiography (CTA)|Subjects underwent CTA, then OCT during cardiac catheterization as part of their standard clinical care.
15791229|NCT04523181|Drug|Antroquinonol|double-blind for antroquinonol and Placebo with same out-look and same frequency.
15791230|NCT04523181|Other|Placebo|Capsule without active compound
15791316|NCT04522362|Other|Control task and Trier Social Stress Task|Same as Arm
15791231|NCT04523168|Device|The Neovasc Reducer™ System|A stainless-steel mesh pre-mounted on a customized hourglass shaped balloon catheter, is designed to create a focal narrowing in the lumen of the CS to generate a pressure gradient across it.
15791232|NCT04523155|Dietary Supplement|Medically tailored meals|10 meals per week for 3 months
15791233|NCT04523142|Drug|CyclASol Ophthalmic Solution|Cyclosporine A solution in vehicle
15791234|NCT04523129|Drug|CyclASol topical ocular, eye drops|Cyclosporine A solution in vehicle
15791235|NCT04523129|Drug|Vehicle topical ocular, eye drops|Vehicle
15791236|NCT04523103|Behavioral|Artificial Assisted Activation|Artificial assisted activation represents an effective technique to rescue the fertilization failure.
15791237|NCT04523090|Drug|Nitazoxanide|Nitazoxanide (NTZ) is licensed in the USA for treatment of diarrhoea caused by Cryptosporidium parvum and Giardia lamblia. NTZ is a pro-drug for tizoxanide, which also has broad spectrum antiviral properties, has many viral indications and shows promising pharmacodynamics against Coronaviridae. NTZ was identified as a first-in-class broad-spectrum antiviral drug and has been repurposed for the treatment of influenza. In vitro studies evaluating tizoxanide, the active circulating metabolite of NTZ, inhibits the replication of broad range of influenza A and B, HIN1, H3N2, H3N2V, H3N8, H5N9, H7N1 and oseltamivir resistant strain and coronaviruses . It has been shown to have anti-viral activity against several viruses including Ebola, hepatitis B and C, rotavirus and norovirus.
15791238|NCT04523090|Drug|Placebo|Placebo pills with no active ingredient.
15791239|NCT04523077|Diagnostic Test|determination of thyroid hormones and antibodies|TSH, fT3, fT4, anti-TPO and anti-Tg were determined from blood sample
15791240|NCT04523064|Drug|Empagliflozin 25 MG|Patients with diabetes waiting for surgery will receive empagliflozin for at least three months.
15791241|NCT04523038|Diagnostic Test|S-Albumin|Preoperative serum albumin levels
15791242|NCT04523025|Diagnostic Test|NLR-ratio|The ratio of neutrophils and lymphocytes in patients blood sample prior to surgical operation
15791243|NCT04523012|Other|Seroprevalence of SARS-CoV-2 infection in patients with HIV infection|On inclusion, after information and collection of the non-objection, a blood sample (D0) will be taken during the assessment of the HIV infection (no unplanned sample will be taken) and a control to determine the appearance or the Persistence of antibodies will be made at M6 and M12 always as part of the assessment of HIV infection.
15791244|NCT04522999|Device|Photobiomodulation|The Valeda™ Light Delivery System
15791245|NCT04522986|Biological|Mesenchymal stem cell|1*10^8 cells are administered once a week, total four times intravenously.
15791246|NCT04522973|Other|Beverage with ethanol and E-cigarette liquid with ethanol|Beverage with ethanol and E-cigarette liquid with ethanol
15791247|NCT04522973|Other|Beverage with ethanol and E-cigarette liquid without ethanol|Beverage with ethanol and E-cigarette liquid without ethanol
15791248|NCT04522973|Other|Beverage without ethanol and E-cigarette liquid with ethanol|Beverage without ethanol and E-cigarette liquid with ethanol
15791249|NCT04522973|Other|Beverage without ethanol and E-cigarette liquid without ethanol|Beverage without ethanol and E-cigarette liquid without ethanol
15791250|NCT04522960|Diagnostic Test|MEG+hdEEG+MRI|"We will perform several tests:
~Neuropsychological testing to evaluate evolution of cognition during our study.
~Lumbar puncture, blood sampling, saliva and urine collection to assess melatonin levels at several timepoints within these biological fluids.
~MEG+hdEEG and MRI (to project MEG information) ; LTM-EEG to detect epileptiform activity in patients and healthy controls"
15791251|NCT04522947|Other|Milkshake fMRI|While in the MRI scanner, the participant is shown a cue indicating the impending delivery of either milkshake or tasteless solution, followed by a brief blank screen, then delivery of the sip, and then a swallow cue. This procedure is repeated throughout the task.
15791252|NCT04522934|Behavioral|Pain Neuroscience Education|Patients received 24 sessions, in an 8-week period, of multimodal physiotherapy (therapeutic heat, manual therapy and exercises) along with four sessions of pain neuroscience education. The latter was focused on the influence of psychosocial factors in the experience of pain, differences between acute and chronic pain and central-peripheral awareness.
15791253|NCT04522934|Behavioral|Biomedical Education|Patients received 24 sessions, in an 8-week period, of multimodal physiotherapy (therapeutic heat, manual therapy and exercises) along with four sessions of biomedical education. The latter was focused on the anatomy and pathomechanics of the shoulder.
15791254|NCT04522921|Dietary Supplement|Diet high on protein (25E%/day)|In a caloric restricted and increased physical activity setting, the control group will consume a low-moderate protein (15E%/day) diet whereas the intervention group will consume a higher protein (25E%/day) diet.
15791255|NCT04522921|Other|Increased follow-up contact after attending a weight loss camp|After leaving the camp, the children and their families with increased follow-up contact will be contacted once every month within the first 6 month and once every other month until 52-weeks follow-up (8 times total). The children and their families will be contacted by phone, facetime or skype as they prefer, within a predetermined and known timeframe. The conversation will focus on individual topics chosen by the child/parent.
15791256|NCT04522908|Drug|Cabozantinib Oral Tablet|Cabozantinib starting dose of 40 mg, oral, once daily for 4 weeks followed by Cabozantinib escalated dose of 60 mg, oral, once daily from week 5 onwards
15791257|NCT04522895|Drug|Enasidenib|Participants in both arms receive up to 12 cycles of Enasidenib.
15791258|NCT04522882|Device|Actimetry|Actimetry will be performed at home to measure physical activity, sleep duration and patient chronotype for 7 days.
15791259|NCT04522882|Other|Questionnaires|Patients will complete food and medication intake questionnaires for 7 days.
15791260|NCT04522882|Other|Glucose level and insulin administration|Continuous subcutaneous glucose level (measured by continuous glucose monitor (CGM)) and the insulin doses delivered by the insulin pump will be collected for 7 days .
15791261|NCT04522869|Biological|Umbilical Cord Derived Mesenchymal Stem Cell (UC -MSC) Transplantation|Umbilical Cord Derived Mesenchymal Stem Cell (UC -MSC) Transplantation for Children Suffering From Liver Cirrhosis Due to Biliary Atresia
15791311|NCT04522427|Device|Use Monofocal intraocular lenses(IOLs)|Monofocal IOLs include 409(Zeiss), AcrySof, TECNIS IOLS
15791312|NCT04522414|Other|cries longitudinally registered|Their cries will be longitudinally registered from the age of birth to the return home using an automatic record device: Song Meter SM4.
15791539|NCT04520516|Device|Sham VAGUSTIM device|The sham device : no electrical signal for VNS will be delivered.
15791262|NCT04522830|Drug|BTL-TML-COVID|"Sublingual dosing of BTL-TML-COVID on days 1 and 2 - Day 1 - 1 drop every 15 minutes for the first hour of initiation of treatment then every hour for the balance of the day until bedtime.
~Day 2 - 1 drop every 2-3 hours for a total of 6 times during the day. The parallel group assignment will only be maintained until the completion of a minimum of 48 hours of blinded study drug dosing, at which point all subjects will receive the active treatment.
~Day 3 - 1 drop every 15 mins for the first hour of the day, then every hour for the balance of the day until bedtime.
~Days 4 through 10 - 1 drop every 3-4 hours for a total of four times during the day."
15791263|NCT04522830|Drug|Placebo|"Sublingual dosing of matching placebo on days 1 and 2 - Day 1 - 1 drop every 15 minutes for the first hour of initiation of treatment then every hour for the balance of the day until bedtime.
~Day 2 - 1 drop every 2-3 hours for a total of 6 times during the day. The parallel group assignment will only be maintained until the completion of a minimum of 48 hours of blinded study drug dosing, at which point all subjects will receive the active treatment.
~Day 3 - 1 drop every 15 mins for the first hour of the day, then every hour for the balance of the day until bedtime.
~Days 4 through 10 - 1 drop every 3-4 hours for a total of four times during the day."
15791264|NCT04522817|Biological|CLBS119|Peripheral blood derived autologous CD34+ cells
15791265|NCT04522804|Drug|Psilocybin|Psilocybin is a classic psychedelic of medium duration that is well-tolerated and has a documented safety and efficacy record that makes it uniquely well-suited to the existential issues that arise in this patient population. Psilocybin has been described as an 'existential medicine' given patient testimonials as to its acute and lasting effects on interpersonal connection, ability to more deeply engage with meaningful activities and relationships, dramatic reductions in fear of death, and a renewed sense of well-being.
15791266|NCT04522791|Behavioral|RFB|The RFB protocol entails a combination of 8 weekly, in-lab training sessions using HRV biofeedback software (Physiocom, Seattle, WA) and daily paced breathing homework using a mobile-based HRV biofeedback app (Inner Balance, HeartMath, LLC, CA).
15791267|NCT04522791|Behavioral|VSOP|The investigators will use the INSIGHT online program (Posit Science). The platform will be built for our study, including 5 tasks (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice different cognitive processes with PS/A as the shared domain.
15791268|NCT04522791|Behavioral|IR|Guided imagery relaxation, equal in dose and frequency to RF practice, will be used to control for relaxation effects that may occur via RFB (which could provide an alternative explanation for outcomes). IR activities will be facilitated using the Insight Timer mobile-based app, which emphasizes the use of visualization and imagery strategies to help the body relax.
15791269|NCT04522778|Device|Wearable Central Line Securement Device (Vest)|The wearable central line securement device is a vest that has attachments for the central line to safely be secured to the body whether it is being used for infusion or unhooked. It also has a front flap, which protects the line from snagging on external objects.
15791270|NCT04522778|Other|Traditional Securement Dressing|This is a adhesive patch that is traditionally used to secure the external portion of a central line.
15791271|NCT04522765|Diagnostic Test|Assessment of 24 hour blood pressure and arterial stiffness|Assessment of 24 hour blood pressure and arterial stiffness using Mobil-o-graph device
15791272|NCT04522752|Other|Size and pathological type of benign epithelial gastric polyp|All subjects will undergo gastroscopy and biopsy to determine the size and pathological type of benign epithelial gastric polyps.The correlation between polyp size and type and polyp development was observed at 6 months, 12 months and 18 months after inclusion.
15791273|NCT04522739|Drug|Spironolactone|The initial dose of spironolactone will be 25mg and will be increased to 50 mg after 2 weeks provided the following criteria are present: 1) systolic blood pressure (SBP) >110 mm Hg, 2) diastolic blood pressure (DBP) > 40 mm Hg, and no reported symptoms of hypotension (dizziness or weakness). Participants will take one capsule by mouth per day.
15791274|NCT04522739|Drug|Placebo|A placebo to match spironolactone will be taken orally once per day.
15791275|NCT04522726|Drug|Weiyang Yuping Fang|Weiyang Yuping fang is a combination of the classic ancient Yuping dispersion used to prevent qi deficiency and susceptibility and Bushen Naqi granules optimized formated by Professor Shao Changrong's experience in treating chronic cough and asthma.
15791276|NCT04522713|Behavioral|Behavioral activation, evidence-based sleep strategies including sleep restriction, exposure-based strategies, promotion of physical activity and recuperating activities, psychoeducational material|Primarily standard cognitive-behavioral strategies to reduce common psychiatric symptoms
15791277|NCT04522700|Procedure|scapular free flap|use of scapular free flap to reconstruction post maxillectomy defect to provide bony support
15791278|NCT04522674|Biological|Autologous platelet rich plasma|0.5 mL autologous platelet rich plasma into a symptomatic osteoarthritic lumbar facet to treat back pain caused by lumbar facet syndrome
15791279|NCT04522661|Procedure|Vitrectomy|Vitrectomy within 48 hours of randomisation
15791280|NCT04522661|Procedure|Intravitreal antibiotics|Intravitreal Antibiotics at 48 hours
15791281|NCT04522648|Other|Prospective surveillance|A participant with an increase from pre-surgery in total arm volume of ≥6% by self-measurement, or symptoms of BCRL ≥2 NRS will receive an assessment by a lymphedema therapist. At this appointment, participants will receive a physical examination of the arm along with a BIS measurement. A participant is considered having subclinical BCRL if an increase in lymphedema index (L-DEX) ≥7 from pre-surgery measured by BIS is identified. A fitted compression garment and gauntlet is then provided, free of charge, for daily wear 10 hours/day for four weeks along with a recommendation to use the arm for daily activities and maintain regular physical activity. Following the four-week compression period, participants will be re-measured using BIS to evaluate response. Participants who do not respond to compression will receive CDT delivered by the lymphedema therapist.
15791282|NCT04522635|Drug|(100 ml of Albumin 25%)|single dose of 25g albumin (100 ml of Grifols 25%) given intravenously at the start of IHD
15791283|NCT04522622|Drug|Teriparatide|20 micrograms
15791313|NCT04522401|Diagnostic Test|"consultation: Bien vieillir"|Patients will benefit from a multidisciplinary assessment including a geriatric assessment standardized by a geriatrician, an evaluation by a dietician, an evaluation by an occupational therapist. They will then be exposed to a personalized plan of care in the form of a recommendation.Then, patients will be followed at home to evaluate the implementation of their personalized care plan at 3 months of their assessment day, then at 6 and 9 months.
15791314|NCT04522388|Dietary Supplement|Ensure Enlive|Ensure Enlive shake twice a day
15791284|NCT04522622|Diagnostic Test|Dual Energy X-ray Absorptiometry (DXA), X-ray, High-Resolution peripheral Quantitative Computed Tomography (HR-pQCT), 18F-Sodium Fluoride Positron Emission Tomography/CT (18-F NAF PET/CT)|All participants undergo DXA and X-ray scans 3 times during the study. Some participants (those connected to Herlev) are offered 18F NAF PET/CT scans at baseline and after 18 months and some participants (those connected to Odense University Hospital) are offered HR-pQCT scans at baseline and after 18 months. The 18F-NAF PET/CT and HR-pQCT are optional, so it is not a must to have these procedures done to participate in the study.
15791285|NCT04522622|Procedure|Bone biopsy|All participants are invited to undergo a bone biopsy after 18 months, but it is not a must to have the procedure done to participate in the study.
15791286|NCT04522622|Diagnostic Test|Cardiac tests|All participants are invited to undergo 24-hour blood pressure measurements and pulse wave measurements at baseline and after 18 months, but it is not a must to have these procedures done to participate in the study.
15791287|NCT04522622|Other|Blood samples and physical examination|All participants must undergo a physical examination and deliver blood samples in order to participate in the study.
15791288|NCT04522622|Other|Circadian variation|The influence of teriparatide on the circadian variation of parathyroid hormon will be investigated in 10 patients. They will stay at Herlev Hospital for 24 hours and have blood samples taken approximately every three hours during their stay. It is not a must to participate in this in order to participate in the study.
15791289|NCT04522609|Device|Neuromuscular electrical stimulation (NMES)|"NMES will carried out with four-channel myostimulator Beurer EM80 (Germany). Self-adhesive electrodes locates above the quadriceps, the duration of the NMES session was 60 minutes, including 5-minute periods of warm-up and warm-down. Throughout the series, rectangular pulses with a frequency of 45 Hz will modulate. As a result, tonic contraction of these muscles will induce for 12 seconds, followed by a pause of 5 seconds. The amplitude of electrical exposure will select separately for each of the four channels until good muscle contraction (visually or by palpation) without pain. Electrical stimulation: 5-6 session per week, for 12 weeks, with 60-minuite session."
15791290|NCT04522596|Drug|Umeclidinium/vilanterol|Umeclidinium/vilanterol 55/22 μg inhaled once a day
15791291|NCT04522596|Other|Placebo|Placebo inhaled once a day
15791292|NCT04522583|Diagnostic Test|Diagnosis of Myocardial Ischemia|Discharge diagnosis of myocardial ischemia
15791293|NCT04522570|Device|Laser ablation|Single session with Diode laser ablation system; one or two applicators will be used for treatments; one to three illuminations; fixed output power of 3 watts (W); pullback technique; delivered energy: 1200-1800 Joules (J) varying according to tumor volume; treatment under local anesthesia +- conscious or moderate sedation;
15791294|NCT04522570|Device|Cryoablation|Single session with Argon-based cryoablation system; one 17 Gauge (G) V-probe applicator will be used for treatments; fixed gas delivery of 100%; treatment under local anesthesia +- conscious or moderate sedation;
15791295|NCT04522570|Device|Radiofrequency ablation|Single session with radiofrequency generator; one 17 Gauge (G) V-tip applicator with a 1 to 4cm active tip; moving-shot technique or multiple overlapping shot technique with 60 Watts (W) output power; treatment under local anesthesia +- conscious or moderate sedation;
15791296|NCT04522557|Drug|IFNα-2a|After mastectomy, it is used in the cavity of breast before conducting implantation.
15791297|NCT04522544|Drug|Tremelimumab|300 mg Tremelimumab C1D1
15791298|NCT04522544|Drug|Durvalumab|1500 mg Durvalumab C1D1 + Q4W (max. 13 cycles)
15791299|NCT04522544|Procedure|Y-90 SIRT|Locoregional therapy will be performed as a standard-of-care procedure
15791300|NCT04522544|Procedure|TACE|Locoregional therapy will be performed as a standard-of-care procedure
15791301|NCT04522531|Other|Open cinetic chain shoulder exercise on unstabil ground|Open cinetic chain shoulder exercise will be performed on BOSU which provides an unstabil ground. This exercises will be include PNF (flexion-adduction-external rotation pattern), PNF (flexion-abduction-external rotation pattern), scapular plan abduction, external rotation while keeping shoulder in 45 degree abduction. The weight which used during exercise planned according to individuals body weight: 0-59 kg: 3 kg; 60-69 kg: 4 kg; 70-85 kg: 5Kg. Exercises will be carried out in 3 phases consisting of concantric, isometric and eccentric phases. Each phase will be lasted 3 seconds. The time will be checked by using a metronome.
15791302|NCT04522518|Device|PmP-C App|"The key features of PmP-C App include: About Me (entering child's demographic data e.g. age, gender, family members), My participation (answering frequency and involvement of activities), and My goal (selecting 3 important activities they desire to change and identify things that made them easy or hard to do, i.e. participation goals and environmental supports or barriers). The App is to be manipulated adult interviewers but also can be manipulated by the child if they are able to."
15791303|NCT04522492|Behavioral|Internet-based Cognitive Behavioral Therapy|2 booster sessions of cognitive behavioral therapy (CBT) delivered thru internet to patients previously treated with CBT. First session focus on understanding the symptoms of skin picking and training techniques to reverse the habit. Second session focus on comorbid symptoms of anxiety and depression, training strategies to improve it.
15791304|NCT04522492|Other|Quality of life promotion|2 videos about quality of life promotion will be send to patients in the active control arm. In the first week, the videos will consist in: social support techniques and sleep hygiene. After one week, 2 another videos will be send, consisting in: guide about healthy diet and about physical exercise.
15791305|NCT04522479|Other|Change the injection time of long acting GnRH-a|The whole dose of long acting GnRH-a drug was changed to be injected on day 21st-23rd day of menstruation
15791306|NCT04522466|Drug|Hydroxychloroquine (HCQ)|"Hydroxychloroquine (HCQ) will be administered as usual practice: dosage is adjusted to maintain a concentration between 1 and 2 mg/L.
~Measure pharmacokinetics and pharmacodynamics of Hydroxychloroquine (HCQ)."
15791307|NCT04522453|Other|paper-based version of mental health Gap Action Program-Intervention Guide|A paper-based guide for diagnosis and management of mental disorders in primary care.
15791308|NCT04522453|Other|digital version of the mental health Gap Action Program-Intervention Guide|A digital guide and client data entry tool for diagnosis and management of mental disorders in primary care.
15791309|NCT04522440|Other|to relieve the pain of inpatients in the hospice Ward|This study will use pain scale, distress thermometer and POMS to understand whether the patient's pain status have changed.
15791310|NCT04522427|Device|Use Multifocal and Extended Depth-of-Focus Intraocular Lenses(IOLs)|IOLs include AT LISA tri 839MP, AcrySof IQ PanOptix IOL, TECNIS Symfony EDOF
15791317|NCT04522349|Device|Greifer then Axon-Hook|Each participant is fitted with a Greifer and assessed after two weeks home-trial. Then he is fitted with Axon-Hook and assessed after two weeks home trial.
15791318|NCT04522349|Device|Axon-Hook then Greifer|Each participant is fitted with a Axon-Hook and assessed after two weeks home-trial. Then he is fitted with Greifer and assessed after two weeks home trial.
15791319|NCT04522336|Drug|Docetaxel|Given IV
15791320|NCT04522336|Drug|Fluorouracil|Given IV
15791321|NCT04522336|Drug|Oxaliplatin|Given IV
15791322|NCT04522336|Biological|Pembrolizumab|Given IV
15791323|NCT04522336|Radiation|Radiation Therapy|Receive radiation therapy
15791324|NCT04522323|Biological|MEDI5752|MEDI5752
15791325|NCT04522323|Drug|Axitinib|INLYTA
15791326|NCT04522323|Drug|Lenvatinib|LENVIMA
15791327|NCT04522310|Other|MR-Pro-ADM|Dosage of MR-pro-ADM
15791328|NCT04522297|Drug|Midodrine/Octreotide|oral midodrine plus octreotide as subcutaneous injection
15791329|NCT04522297|Drug|Nor-epinephrine|Intravenous infusion norepinephrine
15791330|NCT04522284|Device|CURATE.AI|Efficacy and toxicity measurements at the end of each dosing cycle, together with an information on given drugs and their doses, and other patient data, will be used by CURATE.AI to recommend the dose of capecitabine and Ibrutinib for the next cycle. The clinical investigators will decide whether or not to administer or prescribe the dose recommendation from CURATE.AI.
15791331|NCT04522284|Drug|Capecitabine|Treatment with the selected regimen will take up to a maximum duration of 12 months, in 3-week cycles. CURATE.AI dose recommendations will be generated before each chemotherapy cycle; fixed throughout the cycle; and within 1) the predetermined safety range (50% to 100% of dose used in standard of care treatment) and 2) subject-specific dosing range. Maximum total cumulative dose per cycle of capecitabine in the predetermined safety range is set at 100% of standard starting dose (i.e. , 1250mg/m2 twice daily for single agent capecitabine regimen). Minimum total cumulative dose per cycle of capecitabine in the predetermined safety range is set at 50% of the standard starting dose (i.e. 625mg/m2 twice daily for single agent capecitabine). Subject-specific dosing range may alter those numbers to suit the specific circumstances of the subject, thus giving the subject specific safe dosing range.
15791332|NCT04522284|Drug|XELOX|Treatment with the selected regimen will take up to a maximum duration of 12 months, in 3-week cycles. CURATE.AI dose recommendations will be generated before each chemotherapy cycle; fixed throughout the cycle; and within 1) the predetermined safety range (50% to 100% of dose used in standard of care treatment) and 2) subject-specific dosing range. Maximum dose of capecitabine in the predetermined safety range is set at 100% of standard starting dose (i.e. 1000 mg/m2 twice daily for XELOX regimen). Minimum dose of capecitabine in the predetermined safety range is set at 50% of the standard starting dose (i.e. 500 mg/m2 twice daily for XELOX regimen). Subject-specific dosing range may alter those numbers to suit the specific circumstances of the subject, thus giving the subject specific safe dosing range. The doses of other drug in the XELOX regimen (oxaliplatin) will be held constant or adjusted at the clinical investigator's discretion, as per standard of care.
15791333|NCT04522284|Drug|XELIRI|"Treatment with the selected regimen will take up to a maximum duration of 12 months, in 3-week cycles. CURATE.AI dose recommendations will be generated before each chemotherapy cycle; fixed throughout the cycle; and within 1) the predetermined safety range (50% to 100% of dose used in standard of care treatment) and 2) subject-specific dosing range. Maximum dose of capecitabine in the predetermined safety range is set at 100% of standard starting dose (i.e. 1000 mg/m2 twice daily for XELIRI regimen). Minimum dose of capecitabine in the predetermined safety range is set at 50% of the standard starting dose (i.e. 500 mg/m2 twice daily for XELIRI regimen). Subject-specific dosing range may alter those numbers to suit the specific circumstances of the subject, thus giving the subject specific safe dosing range.
~The doses of other drug in the XELIRI regimen (irinotecan) will be held constant or adjusted at the clinical investigator's discretion, as per standard of care."
15791334|NCT04522284|Drug|Ibrutinib|"Treatment with the selected regimen will take up to a maximum duration of 12 months, in 4-week cycles. CURATE.AI dose recommendations will be generated before each chemotherapy cycle; fixed throughout the cycle; and within 1) the predetermined safety range (50% to 100% of dose used in standard of care treatment) and 2) subject-specific dosing range.
~Maximum total cumulative dose per cycle of Ibrutinib in the predetermined safety range is set at 100% of standard starting dose (i.e. 420 mg once daily for 4 weeks, which constitutes the total of 11760 mg per cycle). Minimum total cumulative dose per cycle of Ibrutinib in the predetermined safety range is set at 50% of the standard starting dose (i.e. 280 mg once daily on alternative days with 140 mg once daily, which constitutes the total of 5880 mg per cycle). The dosing range may be altered to suit the specific circumstances of the participant, thus giving the participant-specific safe dosing range."
15791335|NCT04522271|Other|Resistant Starch|7.5 g resistant starch/m2 oral consumption
15791336|NCT04522271|Other|Placebo|Placebo oral consumption of food-grade cornstarch
15791337|NCT04522258|Dietary Supplement|Dietary fiber|Fermentable cereal bran
15791338|NCT04522258|Dietary Supplement|Placebo|Refined cereal flour
15791339|NCT04522245|Behavioral|Noom Healthy Weight; mobile behavior change program for weight loss.|"The mobile cognitive behavior change program follows guidelines from the Obesity Society's 2013 Guidelines for the Management of Overweight and Obesity in Adults NIH Practical Guide on the Identification, Evaluation, and Treatment of Overweight and Obesity in Adults.
~There are 52 weeks of curriculum with 1-3 articles to read per day. Users are requested to perform weight logging once daily and food logging after each meal. Users are assigned human coaches and are able to interact with them via in-app messaging or phone communication. Users are also assigned to support groups via in-app messaging."
15791340|NCT04522245|Other|Matched Control|Matched control group (Noom-branded 'healthy eating' short guide on weight loss).
15791360|NCT04522037|Other|No intervention / Compare the difference in respiratory rate between H0 and H12 of the initiation of morphine between the control and interventional groups|Respiratory rate is analyzed with the scope (approved by the French national medical authorities)
15791361|NCT04522024|Procedure|Epicardial focal cryoablation|Epicardial focal cryoablation on the left atrium around right upper pulmonary vein area
15791362|NCT04522024|Procedure|Mei Mini Maze procedure|Unilateral thoracoscopic epicardial ablation by radiofrequency energy from left side
15791507|NCT04520763|Other|5min respiratory muscle exercises|5 min of hyperpnea at a target intensity of 60-80% MVV 15-30min after ingestion of 75g of glucose
15791341|NCT04522232|Procedure|conventional Total laparoscopic hysterectomy|"the ascending branch of the uterine artery was identified close to the isthmus then ligated at this level, close to the uterus or coagulated, using bipolar diathermy. The utero-vesical fold was dissected and the bladder was pushed down done, thus moving the ureters laterally, which decreases the risk of including them in a suture. The vasculature of the uterus is now secured and this is evidenced by the pale color of the fundus.
~Using either bipolar diathermy or the harmonic ultracision, the cornual pedicles on one side were desiccated and cut. Also, both the uterosacral and cardinal ligaments were desiccated and cut. So that, the opposite side pedicles can be taken care of, the direction of manipulator was changed. The infundibulopelvic ligaments were desiccated and cut if it is necessary to remove both ovaries. A vaginal cuff was inserted into the vagina to identify the vault, which was then cut laparoscopically using a monopolar hook, where the specimen was completely detached."
15791342|NCT04522232|Procedure|Total laparoscopic hysterectomy with prior uterine artery ligation at its origin|"the uterine artery was dissected using the lateral approach; where dissection begins from the anterior leaf of the broad ligament. The triangle enclosed by the round ligament, external iliac artery, and infundibulopelvic ligament was opened. The areolar space was dissected and the origin of the uterine artery from the internal iliac and the ureter was identified. The uterine artery was then isolated from the surrounding structures and ligated by Hem-o-lok clips.
~then same steps as conventional Total laparoscopic hysterectomy"
15791343|NCT04522219|Diagnostic Test|Contrast enhanced ultrasound|Acquisition of contrast enhanced ultrasound. Contrast agent: SonoVue®: Hexafluoride (SonoVue®, injectable solution to solubilisate, 8µg/mL) is injected in all patients
15791344|NCT04522206|Drug|Pre-op Multimodal analgesia (MMA) regimen + standard post-op oxycodone|"The study subjects will be assigned to the defined pre-op MMA regimen with standard postop oxycodone based pain control regimen given on an as needed basis. The treatment group outcomes will be compared to patients outside of the study including a historical control group (receiving only post-op pain regimen) prior to the implementation of the new regimen. The studied treatment group will receive within 3 hours before surgery an oral MMA regimen consisting of:
~Acetaminophen 975 mg Celecoxib 200 mg Gabapentin 300 mg Oxycodone 10 mg Extended Release"
15791345|NCT04522193|Device|Glycemic Holter|Continuous glycaemia monitoring,
15791346|NCT04522193|Radiation|gastric emptying scintigraphy|Fasting administration of a Technecium-labelled milk bottle and quantification of the remaining radioactivity by a camera every 30 minutes for 4 hours.
15791347|NCT04522193|Device|Holter ECG|continuous cardiac monitoring
15791348|NCT04522180|Drug|IONIS-GHR-LRx|IONIS-GHR-LRx will be administered by SC injection.
15791349|NCT04522167|Drug|FYB203 (Proposed aflibercept biosimilar)|Patients will receive 1 IVT injection of FYB203 every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
15791350|NCT04522167|Drug|Eylea® (Aflibercept)|Patients will receive 1 IVT injection of Eylea® every 4 weeks for the first 3 consecutive doses, followed by 1 IVT injection every 8 weeks through study completion.
15791352|NCT04522141|Behavioral|Self-control intervention|Participants will wear a Fitbit for 8 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. Across the 8 weeks, participants receive daily reminders to wear their Fitbit. After the baseline week, participants will also receive interventional components that target self-control via the smartphone application MindHike. This intervention should help them achieve their activity goals. The self-control intervention teaches strategies how to potentiate desirable impulses and how to avoid undesirable impulses in daily life.
15791353|NCT04522141|Behavioral|Control condition|Participants will wear a Fitbit for 8 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. Participants in this condition receive daily reminders to wear their Fitbit through the MindHike smartphone application. Participants in the control group will be matched with the self-control intervention group for how much contact they have with the app and the researchers.
15791354|NCT04522128|Behavioral|Behaviour Change Technique Intervention to Improve Quality of Life|"The intervention targets each facet of the five domains of WHOQOL COMBI. The intervention is based on the COM-B Framework (Michie et al., 2012) and utilises behaviour change techniques to help participants change their behaviour to improve their quality of life.
~The intervention will be compared to an active comparator 'feedback intervention' and a waitlist control group."
15791355|NCT04522115|Other|exercises|"Group(1) aerobic training: Each exercise training session included 3 to 5 minutes of warm-up, range-of-motion exercises, interval training(aerobic training), cool-down, and post-exercise range-of-motion exercises. Patients exercise at 40 to 60% of maximum heart rate.
~Group(2) resistance exercise: training of the lower extremities was performed three times per week. Starting weights for knee extension and hip abduction and flexion were determined from a three-repetition maximum (3RM) using ankle weights that can be adjusted in 1 lb. increments. A 3RM is the maximum weight that can be lifted three times with proper technique. Training started at approximately 60% of 3RM for two sets of 10 repetitions and was increased to three sets as tolerated."
15791356|NCT04522102|Drug|Start antiplatelet monotherapy|Start one antiplatelet drug, be available in local standard clinical practice, chosen by patient's physician pre-randomisation
15791358|NCT04522050|Drug|Gemcitabine combined with cisplatin induction chemotherapy|Patients receive gemcitabine (1000mg/m² d1,8) and cisplatin (80mg/m², d1) every 3 weeks for 2 cycles before radiotherapy. And then intensity modulated radiotherapy (IMRT) is given a total dose of GTVnx 70Gy, GTVnd 66Gy, CTV1 60Gy and CTV2 54Gy for 33 times in total, concurrently with gemcitabine. The initial dose of gemcitabine is 25mg/m² once a week for 6 times. The patients are divided into 9 groups (25mg/m², 50mg/m², 100mg/m², 200mg/m², 300mg/m², 350mg/m², 400mg/m², 450mg/m², 500mg/m²) with 6 patients in each group.
15791359|NCT04522050|Drug|concurrent chemoradiotherapy with gemcitabine|followed by concurrent gemcitabine chemoradiotherapy
15791480|NCT04520971|Device|780G|780G closed-loop insulin delivery system (Medtronic)
15791363|NCT04522011|Other|intraoperative or postoperative hyperthermic intraperitoneal chemotherapy|Intraoperative hyperthermic intraperitoneal chemotherapy：Use docetaxel + oxaliplatin Intraoperately.(Docetaxel 30mg/m2 + oxaliplatin 30mg/m2), perfusion at 43 ℃ for 1 hour
15791364|NCT04521998|Device|electroacupuncture|Electroacupuncture used to reduce the inflammation was proved previously.
15791365|NCT04521998|Device|TENS|Patients who unlike needles would like to choose TENS as treatment for pain relief.
15791366|NCT04521985|Procedure|thoracolumbar kyphosis surgery|patients receiving surgery or not
15791367|NCT04521972|Device|Room light/light bulb|Room light will be ON/OFF or red light used in the room. Reducing/eliminating light in the room in the evening and night is expected to allow the natural release of melatonin, which is thought to promote uterine contractions in late pregnancy.
15791368|NCT04521959|Procedure|Blood flow restricted and normal aerobic exercise and resistance exercise|Interventions of the same duration and intensity will be applied to two groups.
15791369|NCT04521946|Drug|Etoposide|Given IV
15791370|NCT04521946|Drug|Fludarabine Phosphate|Given IV
15791371|NCT04521946|Procedure|Hematopoietic Cell Transplantation|Undergo HCT
15791372|NCT04521946|Biological|Lapine T-Lymphocyte Immune Globulin|Given IV
15791373|NCT04521946|Drug|Melphalan|Given IV
15791374|NCT04521946|Drug|Mycophenolate Mofetil|Given PO or IV
15791375|NCT04521946|Drug|Tacrolimus|Given IV
15791376|NCT04521946|Drug|Thiotepa|Given IV
15791377|NCT04521933|Other|Survey|"Each participant completes a questionnaire. In the questionnaire, he performs a subjective qualitative evaluation of Point-of-Care ultrasound records of the heart.
~Each participant will complete a questionnaire in which they perform a subjective qualitative evaluation of ultrasonographic recordings of the heart."
15791378|NCT04521920|Drug|Suboxone|Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
15791379|NCT04521920|Drug|PrEP|Enrolled participants will be prescribed PrEP and/or Suboxone. Follow up visits will be conducted by telemedicine. We are testing whether telemedicine is a feasible method for follow up.
15791380|NCT04521894|Device|Positron emission tomography/computerized tomography (PET/CT)|"Genetic factors and age:
~Epidemiological studies have shown that if an immediate family member (brother or father) suffers from prostate cancer, the risk of prostate cancer will be more than doubled. Age is a relatively strong risk factor for PCa.
~Prostatitis: Prostatitis is related to PCa. Cancer is usually found in the tissues where inflammation is found.
~Obesity: Research has found that obese patients have a low grade of PCa, but their risk of developing aggressive cancer is higher.
~Infection:
~Exercise: Most studies have found that exercise does not reduce the risk of prostate cancer, but some studies have shown that.
~Daily diet: The corrective mechanism of diet in PCa is not very clear.
~Drinking history:"
15791382|NCT04521868|Drug|Sulforaphane|Sulforaphane is a compound that can be extracted from broccoli, Brussel sprouts, cabbage, and other cruciferous plants.
15791383|NCT04521868|Dietary Supplement|placebo|Placebo is made of starch
15791384|NCT04521855|Other|Questionnaire|Questionnaires in French on the quality of life, the burden of caregiving and a screening for depressive symptoms, completed during specific interviews.
15791385|NCT04521842|Procedure|Total hip replacement|Total hip replacement in treatment of end-stage osteoarthritis
15791386|NCT04521829|Other|Walking with different optic flow speeds with 2 different VR devices|Participants will perform 2 sessions of VR-enhanced treadmill walking. One session with the GRAIL system (semi-immersive) and the other session with a fully immersive head-mounted display (Oculus Rift S). In both sessions, the speed of the optic flow will be manipulated: equal to, 2 times faster and 2 times slower than the participant's comfortable walking speed.
15791387|NCT04521816|Behavioral|PACT Intensive Management|"Purpose: Implement a Patient Aligned Care Team (PACT) model that identifies and proactively manages Veterans at the highest risk for hospital admission and death while they are still in the ambulatory care setting.
~Goal:
~Reduce emergency department and urgent care utilization, hospitalization, and mortality in complex, high risk patients
~Improve Veteran and staff satisfaction
~Objectives:
~Maintain the patient in the home setting as much as possible
~Secure appropriate home environment to facilitate health and well-being
~Utilize comprehensive team-based care
~Engage appropriate VHA programs to provide interdisciplinary, coordinated, and timely management of complex medical issues"
15791388|NCT04521803|Drug|high dose Rifampicin (RIF)|Simulations were performed to determine the dose of RIF required to achieve the most equitable drug exposures across the weight range, 30 to 100 kg. Demographic data of a reference cohort of TB patients (n = 1225), with or without HIV-1 coinfection, recruited in clinical trials conducted in West Africa and South Africa were used for the simulations35-38. An additional 12 250 virtual patients were generated using the weight and height distributions of the 1225 patients to increase the number of patients with a weight close to the boundaries of the weight range. Parameter estimates of the population PK model for RIF were used to simulate (100 replicates) RIF exposures22. Four dosing scenarios were evaluated using the weight-band based dosing with 4-drug FDC tablets and extra RIF tablets with each tablet containing 150 mg or 600 mg RIF. The FDC tablets were assumed to have 20% reduced bioavailability based on data from a clinical trial where the same formulation was used
15791389|NCT04521790|Other|support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation|Treatment will be patient-tailored, integrating international guidelines recommendation and the experience of the center where enrollment takes place.
15791390|NCT04521777|Behavioral|Exercise Intervention|Participate in an 8-week home-based strengthening and walking program
15791391|NCT04521777|Other|Physical Performance Testing|Complete a physical function test
15791392|NCT04521777|Other|Questionnaire Administration|Ancillary studies
15791393|NCT04521764|Biological|Oncolytic Measles Virus Encoding Helicobacter pylori Neutrophil-activating Protein|Given IT
15791394|NCT04521751|Drug|EMP16-02 120 mg orlistat/40 mg acarbose|EMP16-02 capsules are composed of three pharmaceutical fractions (granules denoted G1, G2 and G3). G1= Prolonged release of acarbose, G2= Enteric-coated granule fraction containing orlistat and acarbose, G3= Orlistat with a delayed on-set release mechanism.
15791481|NCT04520971|Device|standard of care|continue with standard of care treatment (pump without closed-loop or MDI)
15791395|NCT04521751|Drug|EMP16-02 150 mg orlistat/50 mg acarbose|EMP16-02 capsules are composed of three pharmaceutical fractions (granules denoted G1, G2 and G3). G1= Prolonged release of acarbose, G2= Enteric-coated granule fraction containing orlistat and acarbose, G3= Orlistat with a delayed on-set release mechanism.
15791396|NCT04521751|Drug|Placebo|Matching oral placebo capsules
15791397|NCT04521738|Drug|SAR441255|"Pharmaceutical form:solution for injection
~Route of administration: subcutaneous"
15791398|NCT04521738|Drug|placebo|"Pharmaceutical form:solution for injection
~Route of administration: subcutaneous"
15791399|NCT04521725|Device|Respiratory Function Monitor (RFM)|Use of respiratory function monitor to detect tidal volume and expired CO2 to guide mask ventilation during neonatal resuscitation.
15791400|NCT04521725|Device|Cerebral Near-Infrared Spectroscopy (NIRS)|Use of cerebral NIRS to determine cerebral oxygenation to guide oxygen titration during neonatal resuscitation.
15791401|NCT04521712|Diagnostic Test|2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitor|All women enrolled in this study will have a 2-hour 75-g oral glucose tolerance test performed immediately postpartum (within 4 days of delivery), at 4-6 weeks postpartum, and at 6 months postpartum. Enrolled women will also wear a continuous glucose monitor for 10 days at each of these time periods. Both women and their infants will have skin fold thickness measured at each of these 3 study visits to estimate body fat composition. Additionally umbilical cord blood and placental biopsies will be collected at delivery and stored for future research.
15791403|NCT04521686|Drug|LY3410738|Oral LY3410738
15791404|NCT04521660|Device|Virtual reality glasses|Virtual reality (VR) is a new method that can be used to distract and prepare patients for the procedure during medical procedures. It is an advanced technology that allows the individual to move into a virtual environment and focus his attention on other thoughts to less consideration for pain and anxiety. In this study, VR glasses will be worn on the intervention group just before the procedure begins and patients will continue to wear their glasses until the procedure is completed.
15791405|NCT04521647|Drug|Nicotine|Participants will receive two nicotine concentrations via e-cigarettes. Each exposure will be 10 3-sec puffs and ad libitum use
15791406|NCT04521621|Biological|V937|Participants receive V937 intratumorally for 1 28-day cycle followed by 7 21-day cycles.
15791407|NCT04521621|Drug|Pembrolizumab|Participants receive pembrolizumab intravenously for 1 28-day cycle followed by 34 21-day cycles.
15791408|NCT04521608|Behavioral|Intervention- Home-based Pulmonary Rehabilitation|Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that will allow patients to complete PR at home. The program involves upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).
15791409|NCT04521595|Behavioral|Weigh Smart Telehealth intervention|Trial of the group program (nutrition, exercise) delivered via telehealth through fruit street on the Eastern Shore and Western Maryland with use of noninvasive lifestyle tracking options (drink water aquarium app for water consumption and fitbit - steps, sleep monitoring) provides novel options for expansion of family- based lifestyle intervention to underserved areas. We plan as a pilot study to assess the sensitivity of noninvasive measures for the detection of sleep apnea (pediatric sleep questionnaire (PSQ) and fitbit sleep data) in comparison to clinically indicated polysomnography among children with clinical suspicion for sleep apnea.
15791410|NCT04521582|Drug|Amlodipine|The facility-based community health worker will receive protocol-driven training to initiate amlodipine for hypertensive patients. These patients will receive lifestyle counseling by Female Community Health Volunteer through home visits (5 times [including baseline and end of the study] in the active municipality and 3 times [including baseline and end of the study] in the control municipality).
15791411|NCT04521582|Behavioral|Lifestyle counselling|Female Community Health Volunteer will provide lifestyle counseling at the participant's home
15791412|NCT04521569|Drug|Regadenoson|If the donor lungs are randomized the experimental arm, the administration of Regadenoson will be performed at each study site by a qualified medical professional. The donor lungs will be perfused with Regadenoson at a dosage of 1.44 microgram/kg/min (based on donor's weight) for a minimum of three hours and maximum of four hours, using a pediatric syringe pump into the EVLP circuit (XVIVO Perfusion System). The infusion will begin within 10 minutes of the start of the EVLP procedure. Once the EVLP is complete the lungs are re-flushed with Perfadex solution (removing the Steen™ solution and Regadenoson; standard for EVLP).
15791413|NCT04521569|Drug|Placebo|If the donor lungs are randomized to the Steen solution arm, the donor lungs will be perfused with placebo at a rate equivalent to the dosage of Regadenoson (1.44 microgram/kg/min), for a minimum of three hours and maximum of four hours, using the same pediatric syringe pump. The infusion will begin within 10 minutes of the start of the EVLP procedure.
15791414|NCT04521556|Procedure|Epidural anesthesia with light general anesthesia|"Epidural anaesthesia: mixture of ropivacaine 6.5 mg/ml and fentanyl 8.3 μg/ml.
~Light general anesthesia: isoflurane in mixture of 50/50 of nitrous oxide and oxygen to achieve Minimum alveolar concentration between 0.6 and 0.8."
15791415|NCT04521556|Procedure|Postoperative epidural analgesia|Before the end of operation was given 4 ml of the mixture of ropivacaine 4.4 mg/ml and morphine 0.8mg/ml. Epidural analgesia was continued for next 24 hours with a mixture of ropivacaine 2.2 mg/ml and morphine 0.4 mg/ml.
15791416|NCT04521556|Procedure|General anesthesia|"Maintaining general anesthesia: nitrous oxide and oxygen in mixture 50/50 and isoflurane to achieve minimum alveolar concentration between 0.8 and 1.
~Fentanyl loading dose: 6-8 μg/kg. Additional fentanyl doses were given incrementally."
15791417|NCT04521556|Drug|Continuous intravenous analgesia|Tramadol 100 mg in the first hour followed by tramadol 300 mg continuously for the next 24 hours.
15791418|NCT04521530|Other|immediate functional implant loading|Patients will undergo implant placement and a minimum of 35 Ncm reading with the graded torque wrench. Temporary crowns in functional occlusion were cemented.
15791419|NCT04521530|Other|immediate non functional implant loading|implant will be placed into the site following the manufacturer's protocol making sure to have a minimum of 35 Newton centimeter reading with the degraded torque wrench. Non-functional temporary crowns were cemented.
15791508|NCT04520763|Other|15min respiratory muscle exercises|5 min of hyperpnea at a target intensity of 60-70% MVV 15-30min after ingestion of 75g of glucose
15791420|NCT04521517|Behavioral|pamphlet describing the timing of family planning during postpartum with methods advantages and disadvantages of family planning|a pamphlet describing the timing of family planning during postpartum with methods advantages and disadvantages of family planning
15791421|NCT04521504|Device|Kinematic biofeedback with ISEO motion analysis system|Exercises are performed with the help of the ISEO motion analysis system, that provides a real-time biofeedback of shoulder kinematics. All exercises are administered by the Physical Therapist.
15791422|NCT04521491|Drug|FOLFOX4(infusional fluorouracil [FU], leucovorin [LV], and oxaliplatin [OXA]).|FOLFOX4 (OXA 85 mg/m2 intravenously [IV] on day 1; LV 200 mg/m2 IV from hour 0 to 2 on days 1 and 2; and FU 400 mg/m2 IV bolus at hour 2, then 600 mg/m2 over 22 hours on days 1 and 2, once every 2 weeks.All patients in the treatment group will receive FOLFOX4 at most 12 times beginning from the 4th week after liver resection.
15791426|NCT04521465|Device|NovaTears® + Omega-3 (Perfluorohexyloctane with 0.2% w/w Omega-3 fatty acid ethyl esters)|Eye drops
15791427|NCT04521452|Drug|Evogliptin|Subjects will receive evogliptin 5 mg daily
15791428|NCT04521439|Diagnostic Test|18F-florbetapir PET+MRSI|PET and MRS quantitative parameters in MS lesions are simultaneously analyzed using hybrid PET/MR for obtaining demyelination and neuronal damage information.
15791429|NCT04521426|Other|No other than standard care|No other than standard care.
15791430|NCT04521413|Drug|CFI-402411|CFI-402411 is administered orally once daily. The starting dose is 80 mg/day for escalation arms and the recommended dose for the expansion arms.
15791431|NCT04521413|Drug|Pembrolizumab|Pembrolizumab will be given at its labeled dose and schedule, 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks.
15791432|NCT04521400|Drug|High dose Interferon-beta 1a|High dose IFN-β1a (Recigen) (Subcutaneous injections of 88μg (24,000 IU) on days 1, 3, 6)
15791433|NCT04521400|Drug|Lopinavir/Ritonavir|Lopinavir/Ritonavir (Kaletra) [IFN-β1a group] (400mg/100 mg twice a day for 10 days
15791434|NCT04521400|Drug|Low dose Interferon-beta 1a|Low doseIFN-β1a (Recigen) (Subcutaneous injections of 44μg (12,000 IU) on days 1, 3, 6)
15791435|NCT04521387|Procedure|injection therapy|The injection will be carried out with aseptic precautions, under regional anesthesia with 2ml of 2% Lignocaine through one puncture of the skin and frequent changes in the inside needle position.
15791436|NCT04521387|Drug|Platelet Rich Plasma|Platelet rich plasma injection in the painful area of humeral epicondyle.
15791437|NCT04521387|Drug|Corticosteroid Injection|Corticosteroid injection in the painful area of humeral epicondyle.
15791438|NCT04521387|Drug|Hyaluronic Acid Injection|Hyaluronic acid injection in the painful area of humeral epicondyle.
15791439|NCT04521387|Other|Placebo Injection|Saline injection in the painful area of humeral epicondyle.
15791440|NCT04521374|Behavioral|Preload meals that are solid or texture modified and are fortified with protein or not fortified with protein|Immediately after consuming the preload meal, volunteers will use a 100mm visual analogue scale (VAS) to rate their liking towards the meal, their hunger, fullness, desire to eat and prospective food intake. Subsequently, they will record these every 30 minutes until they consume their ad-libitum dinner
15791442|NCT04521348|Drug|multiple tyrosine kinase inhibitor(mTKI) Combined with anti-PD-1 antibody|Patients receive Multiple Target Kinase Inhibitor(mTKI) Combined with Anti-Programmed Death-1(PD-1) Antibody
15791443|NCT04521335|Drug|Disulfiram|Patients will be instructed to self-administer disulfiram and copper gluconate twice daily at the assigned dose level. Both medications will be administered in 28-day cycles.
15791444|NCT04521335|Drug|Copper Gluconate|Patients will be instructed to self-administer disulfiram and copper gluconate twice daily at the assigned dose level. Both medications will be administered in 28-day cycles.
15791445|NCT04521322|Drug|Iota-Carrageenan|Participants will received a nasal spray with Iota-Carrageenan or placebo 4 times a day during 21 days
15791446|NCT04521309|Biological|SARS-CoV-2 antibody based IVIG therapy|"Patient groups will receive IVIG prepared from pooled convalescent plasma from recovered COVID-19 patients. This will be administered sequentially and in varying dosages, infused over a period of 12 hours, intravenously.Additionally, all treatment groups will receive same standard care as control group. Standard Care as per hospital protocol, which may include:
~Airway support, Anti-Viral medication, Antibiotics, Fluid Resuscitation, Hemodynamic Support, Steroids, Painkillers, Anti-Pyretics"
15791447|NCT04521296|Other|Part 1|- DWJ1248 600mg PO (100mg 2 tab, TID)
15791448|NCT04521296|Other|Part 2|- DWJ1248 600mg PO (200mg 1 tab, TID)
15791449|NCT04521244|Other|Thrust joint lumbar manipulation|Moist Hot pack of 14/15' over lumbar region for 15 mins. Hydro collator Temperature according to standardized hot pack is 40-45οC.Bilateral Thrust Manipulation of Lumbar Spine from L1-L5 Baseline Algometer for springing force tolerance and Lumbar Inclinometry using dual inclinometer for lumbar flexion, extension and goniometer for lumbar side bending.These pre and post intervention values were mentioned in questionnaire. The participants were administered with thrust and non-thrust manipulation of the lumbar spine and data was collected again immediately after the interventions without any delay.
15791450|NCT04521244|Other|Lumbar mobilization|Moist Hot pack of 14/15' from L1 where ribcage ends up to the region of gluteal folds for 15 mins. Non Thrust Manipulation for 30 seconds Using Kaltenborn grade 3 (Stretch rotation mobilization).Baseline Algometer for springing force tolerance and Lumbar Inclinometry using dual inclinometerfor lumbar flexion, extension and goniometer for lumbar side bending. These pre and post intervention values were mentioned in questionnaire. The participants were administered with thrust and non-thrust manipulation of the lumbar spine and data was collected again immediately after the interventions without any delay.
15791451|NCT04521231|Drug|Blinatumomab|Blinatumomab will be administered as a subcutaneous (SC) injection.
15791482|NCT04520958|Behavioral|Mindfulness of Breath|Mindfulness of Breath consisted of instruction in focused attention on the breath and metacognitive monitoring and acceptance of discursive thoughts, negative emotions, and pain.
15791509|NCT04520750|Drug|PTX-022|Safety and Efficacy of PTX-022 in the Treatment of Adults with Pachyonychia Congenita
15791452|NCT04521218|Other|Thrust Joint Manipulation|"Experimental group included TJM, Cervical hot pack, strengthening exercises and home plan; 3 sessions of manipulation per week and total of 4 weeks. Measurement will be taken at base level and after the last session, i.e. Pain intensity, pain pressure threshold, ROM, and disability.
~These exercises included. Cervical Flexion, Extension Rotation, lateral flexion and back strengthening exercises. These all exercises were performed 3 x 15 Repetitions with 10 sec hold. This protocol was for 4 weeks and 3 sessions per week.
~Home plan exercises includes Craniocervical Flexion, Craniocervical Extension, Rotation Exercise, Lateral Flexion Exercise, Chin Tuck in and Shoulder blade exercise were advised to perform 3 x 10 Repetition with 10 - 30 sec hold."
15791453|NCT04521218|Other|Reverse Sustained Natural apophyseal glides|"Control group included Moist Hot Pack (Cervical contour- 8.25 x 10 x 2) for 10 Mins, Reverse SNAGS (10 Repetitions holding for 10 sec in each glide with a rest time of 30 seconds in between), Strengthening exercise and home plan. 3 sessions of mobilization per week and total of 4 weeks. Measurement will be taken at base level and after the last session, i.e. Pain intensity, pain pressure threshold, ROM, and disability.
~These exercises included. Cervical Flexion, Extension Rotation, lateral flexion and back strengthening exercises. These all exercises were performed 3 x 15 Repetitions with 10 sec hold. This protocol was for 4 weeks and 3 sessions per week.
~Home plan exercises includes Craniocervical Flexion, Craniocervical Extension, Rotation Exercise, Lateral Flexion Exercise, Chin Tuck in and Shoulder blade exercise were advised to perform 3 x 10 Repetition with 10 - 30 sec hold"
15791454|NCT04521205|Drug|fecal microbiota capsule|a capsule full of fecal microbiota extracting from the health
15791455|NCT04521192|Drug|Fluzoparib|the first period: test preparation; the second period: reference preparation
15791456|NCT04521192|Drug|Fluzoparib|the first period: reference preparation the second period: test preparation
15791457|NCT04521179|Drug|KN026 combination|30 mg/kg Q3W KN026+ 5 mg/kg Q3W KN046
15791458|NCT04521166|Device|Hearing aid|Settings in a wearable hearing aid will be adjusted within a clinically-relevant range for two features. The features include wide dynamic range compression and microphone directionality.
15791459|NCT04521153|Drug|Camrelizumab|Camrelizumab is administered at 200mg, q2w (2cycles) before radical surgery and 200mg, q3w (at least 6 cycles) after radical surgery
15791460|NCT04521153|Drug|Apatinib Mesylate|Apatinib Mesylate is administered at 250mg, qd (2 cycles) before radical surgery and 250mg, qd (at least 6 cycles) after radical surgery
15791461|NCT04521153|Procedure|TACE treatment|TACE treatment
15791462|NCT04521153|Procedure|Radical surgery|Radical surgery
15791463|NCT04521140|Drug|Dextenza 0.4Mg Ophthalmic Insert|DEXTENZA is a corticosteroid intracanalicular insert placed in the punctum, a natural opening in the eye lid, and into the canaliculus and is designed to deliver dexamethasone to the ocular surface for up to 30 days without preservatives.
15791464|NCT04521140|Drug|Prednisolone Acetate 1% Oph Susp|Prednisolone Acetate 1% is a corticosteroid used as a topical drop after corneal transplant to decrease inflammation and prevent graft rejection
15791465|NCT04521127|Other|Kinesio Taping|Taping will be performed on sitting position with contralateral lateral flexion and flexion of the neck, using muscle technique with I strip and stretching the head at the maximum level in order to benefit from the muscle release effect. Kinesio tape was applied directly on muscle with 0% stretching.
15791466|NCT04521127|Other|Dry needling|The trigger point on the taut band will be held with the thumb and forefinger from below and above. In the needling technique, a 0.25 * 25-mm with nickel handle, disposable sterile steel acupuncture needle will be used. The needle tip will be inserted perpendicularly into the subcutaneous tissue and inserted into the muscle until the trigger point in the taut band was found. The same point will be pinned 8-10 times with fast needle movements inside and out. Then the needle tip will pulled back so that it did not come out of the skin, and the bottom, top and sides of the first entered point were also pinned. This procedure was applied to all trigger points in the trapeze muscle.
15791467|NCT04521114|Drug|Placebos|Placebo will be administered subcutaneously every week for 13 weeks.
15791468|NCT04521114|Drug|leronlimab|700 mg leronlimab will be administered subcutaneously every week for 13 weeks.
15791469|NCT04521101|Other|VAST Course|Educational course to teach non-technical skills
15791470|NCT04521075|Biological|Fecal Microbial Transplantation by capsules|"Cohorts A and B - Patients will receive 30 oral capsules per administration for two consecutive days (Days 1-2) Cohort C - Patients will receive FMT via colonscopy (Day 1), followed the day after by adnistration of 12 oral capsules (Day 2)
~Combination cycles: 6 combined cycles Q2W of FMT maintenance followed by treatment with anti-PD1. Anti-PD-1 will be administered at least one day and up to 3 days after the FMT.
~Maintenance of FMT by oral capsules: 12 capsules per administration. Anti PD-1 therapy: A dose of 240 mg Nivolumab will be administrated by intravenous infusion."
15791471|NCT04521062|Device|Dilapan S|Placement of Dilapan S
15791472|NCT04521049|Drug|Saxagliptin 5mg|Patients would be assigned to saxagliptin (Onglyza® AstraZeneca Pharmaceuticals LP, Indiana, USA), either received a dose of 5 mg or 2.5 mg daily if patients had eGFR <50 mL/min/1.73 m2
15791473|NCT04521036|Biological|Convalescent Plasma as Therapy for Covid-19 patients|Patients in the treatment group will receive 500 ml from COVID-19 recovered donors
15791474|NCT04521023|Drug|Cantabell Tab|Patients assigned to experimental group are treated with Cantabell Tab
15791475|NCT04521023|Drug|Candemore Plus Tab|Patients assigned to experimental group are treated with Candemore Plus Tab
15791476|NCT04521010|Other|COVID-19 pandemic|The aim of the study was to evaluate the staff absenteeism in the initial period of the COVID-19 pandemic at Wiktor Dega Orthopedic and Rehabilitation Clinical Hospital in Poznań Poznań as well as to assess the level of performance of medical services that were assigned to the Hospital under contract with National Health Fund, the payer of public health services in Poland.
15791477|NCT04520997|Device|Restylane Defyne|Hyaluronic acid filler
15791478|NCT04520984|Other|Integrated ambulatory palliative and nephrology care|"Monthly ambulatory care visits with the kidney palliative care team in the intervention group for three months.
~The intervention in this study is addition of a palliative care team to the care team of the subject. This intervention will not change or impact their regular nephrology care. The subjects in the intervention arm will be seen by the palliative care team three times over the 12-week study period (once per month).The intervention will be delivered by a physician trained in both palliative care and nephrology, the PI of the study."
15791479|NCT04520984|Other|Standard nephrology care|Standard nephrology care
15791483|NCT04520958|Behavioral|Mindfulness of Pain|Mindfulness of Pain consisted of instruction in how to (1) zoom in to deconstruct pain into its constituent physical sensations and precisely map each sensation's spatial location, (2) use mindful breathing to zoom out and broaden the field of attention to include previously neglected sensory elements (i.e., spaces within the body that were absent of sensation and pleasant sensations), and (3) shift attention from unpleasant sensations to neutral/pleasant sensations or experiences.
15791484|NCT04520958|Behavioral|Cognitive-Behaviorally Based Pain Psychoeducation|Cognitive-Behaviorally Based Pain Psychoeducation consisted of psychoeducation about the link between thoughts, emotions, and behavior and provided instruction in the use logic to dispute maladaptive thoughts about pain that might otherwise exacerbate pain and distress.
15791485|NCT04520945|Biological|Chondrogen|Mesenchymal stem cell-derived from umbilical cord Wharton Jelly and hyaluronic acid
15791486|NCT04520945|Biological|Placebo|Consist of saline and hyaluronic acid
15791487|NCT04520932|Procedure|Radiofrequency ablation|RFA is performed under general anaesthesia, under high endoscopic echo-endoscopy (EEH), in left lateral decubitus position, using the StarMed generator from Taewong®.
15791488|NCT04520919|Other|anesthesia;Radial artery puncture|we chose the patients who need to monitor invasive blood pressure to obtain high-fidelity arterial waveforms
15791489|NCT04520906|Device|microwave ablation|ultrasound-guided microwave ablation is performed to treat hepatocellular carcinoma patients
15791490|NCT04520893|Procedure|ventilator setting vcv with pause|ventilator setting vcv with pause
15791491|NCT04520893|Procedure|ventilator setting vcv|ventilator setting vcv without pause
15791492|NCT04520893|Procedure|ventilator setting pcv-vg|ventilator setting with pcv-vg
15791493|NCT04520880|Diagnostic Test|Testing procedure for Binding antibodies|Levels of S-specific and N-specific binding antibodies will be measured by enzyme immune-sorbent assay (ELISA). Briefly, a purified, recombinant S or N proteins will be coated into 96-well plates and incubated for 1 hour at room temperature. The plates will be then washed with 1X PBS five times. The unbound regions of the coated S proteins are blocked by 5% non-fat dry milk. After overnight incubation at 4 C. The plates are washed several times with 5X PBS. Patients sera samples are added in duplicate and incubated for 1 hour at room temperature. After several washes. anti-human IgG HRP conjugate is added. After 1-hour incubation at room temperature, the plates are washed with 1X PBS five times 3,3', 5,5' tetramethylbenzidine (TMB) substrate is added to each wells and incubated for 5 minutes. The reaction will be then stopped with 0.2 M sulfuric acid and the absorbance is measured at 450nm.
15791494|NCT04520880|Diagnostic Test|Neutralizing antibodies|Neutralizing antibodies against the S protein of SARS-CoV-2 are measured by PV microneutralization assay. Briefly, individual plasmids expressing S.fl gene, luciferase genes, and reporter genes are co-transfected into 293T cells to produce luciferase-expressing pseudo-viruses. Then, pseudo-viruses are added at equal volume into 96 well plates and incubated at 37 for 1 hour. Then, the ACE2 expressing 293T cells are added into the 96well pates with 100 ul of patients' sera in duplicates. After, a single round of replication the cells are lysed with lysis buffer. Luciferase activity is measured by the luciferase assay kit. The activity of luciferases is proportional to the number of cells infected. Luciferase activity is then measured by the luminometer device and the neutralization rate is calculated.
15791495|NCT04520867|Other|STRENGTH|Patients with esophageal (EC) and gastroesophageal junction (GEJC) cancers who are seen in the Esophageal and Gastric Multidisciplinary Clinic (EGMDC) for treatment planning and are recommended to receive neoadjuvant therapy and plan to receive treatment at UCCC Metro will be offered enrollment into the study. Patients will complete the patient reported assessments focused on QOL and physical activity on provided tablet computers during UCCC visits at specified time points. If unable to complete assessments in person they will be e-mailed to the patient via REDCap to complete. Additional data regarding dosing of chemotherapy, radiation, nutrition and surgical outcomes will be collected.
15791496|NCT04520854|Other|Telehealth Protocol|"The first live-video session will orient participants to the features of the software, discuss the checklist to minimize environmental distractions, gauge how participants are managing their symptoms (pain, swelling) and provide non-pharmacological alternatives to supplement their current treatment strategies.
~The second live-video session will be used re-examine how the participant is managing their symptoms (pain, swelling) and re-emphasize non-pharmacological alternatives.
~The remaining live-video sessions will be focused on giving participants home-based therapeutic exercises. The therapeutic exercises will target the four main areas important to ankle sprain recovery: 1) range of motion; 2) balance; 3) gait; and 4) strength. All of the therapeutic exercises are based on previously published criteria for the rehabilitation of an LAS. The progression will start with single-plane, non-weight bearing or low-force activities and will advance at the same rate."
15791497|NCT04520854|Other|Usual Care|The usual care group will be instructed to follow their treating physicians' orders. Participants will not receive instructions on how to self-manage symptoms nor a home-based exercise program.
15791498|NCT04520841|Device|Prevena TM|A Prevena Plus DuoTM Dressing Kit (KCI) is applied on the surgical wound at the end of surgery.
15791499|NCT04520841|Device|Dry dressing|A standard dry sterile dressingwith non-adherent absorbent pad is applied on the surgical wound at the end of surgery
15791500|NCT04520828|Other|postural repositioning|The 10-min transdisciplinary intervention aimed (1) to facilitate and activate axial extension during standing and then during sitting; (2) to actively mobilize the trunk, cervical spine, and pelvic and shoulder girdles during standing and then during sitting; and (3) to adjust the seated position, as needed, with supports to ensure its maintenance throughout the experiment. Cushion, balls, boxes, or rolls were used to stabilize the final seated position.
15791501|NCT04520802|Diagnostic Test|18F-DPA-714 PET/CT neuroimaging|"Pre- and postoperative neuroimaging using 18F-DPA-714 PET/CT and brain MRI.
~Longitudinal neuropsychological examinations (up to 6 months postoperatively)
~Blood samples are drawn to assess the severity of the systemic inflammatory response"
15791502|NCT04520789|Diagnostic Test|RPE cell collection and single cell heterogeneity study|Study of initiating proliferative vitreoretinopathy (PVR)cell subtype (PVR initiating cells (PVR-IC) in RPE cells of rhegmatogenous retinal detachment (RRD) patients, the percentage of which decides the risk of serious PVR occurring after surgery.
15791503|NCT04520789|Procedure|Postoperative intervention|Early local steroids drug intervention in patients with severe postoperative PVR
15791504|NCT04520789|Procedure|Conventional Surgery for Retinal Detachment|Conventional Surgery for Retinal Detachment
15791510|NCT04520737|Behavioral|Physical Prehabilitation|The prehabilitation program consists of the following interventions: in-hospital high-moderate intensive exercise training, nutritional assessment and high-protein supplementation, smoking cessation, psychological support and Comprehensive Geriatric Assessment.
15791511|NCT04520724|Dietary Supplement|plant fiber|The patients with NAFLD (study and control group) will receive low-processed rolls with an 12 g plant fiber content twice daily, which would be a convenient for easy replenishment of the amount of vegetable fiber (act as prebiotic) in the diet. The intervention will be preceded by a 21 day wash-out period during which subjects will be asked to avoid foods containing large amount of fiber.
15791512|NCT04520724|Dietary Supplement|maltodextrin bar|The patients with NAFLD (placebo group) will receive maltodextrin bars twice daily, which would be a convenient and easy-to-eat snack replacing the second breakfast and afternoon tea. The bars must be eaten with 180 ml of water or unsweetened liquid. The intervention will be preceded by a 21 day wash-out period during which subjects will be asked to avoid foods containing large amount of fiber.
15791513|NCT04520711|Biological|TCR-transduced T cells|TSA-reactive TCR-engineered T cells
15791514|NCT04520711|Drug|CDX-1140|Recombinant fully human IgG2κ monoclonal antibody
15791515|NCT04520711|Drug|Pembrolizumab|Humanized immunoglobulin G4 (IgG4) monoclonal antibody
15791516|NCT04520698|Behavioral|UPLIFT-AD|Access to palliative care needs screening, advance care planning conversations, palliative care consultations
15791517|NCT04520685|Drug|Oral cannabidiol 100mg/mL|In Arm 1, patients will begin CBD in period 1 and receive placebo in period 2. In Arm 2, patients will begin placebo in period 1 and receive CBD in period 2. In Arm 3, patients will receive CBD for the entire 27 week study duration without washout. Each study period is 12 weeks and dose will be titrated up for 1 week at the beginning of a treatment period and titrated down for 1 week at the end of a treatment period, with a two week placebo washout between periods for Arms 1 and 2. The titration dose will be 5mg/kg/day and the treatment dose will be 10mg/kg/day.
15791518|NCT04520685|Drug|Placebo|In Arm 1, patients will begin CBD in period 1 and receive placebo in period 2. In Arm 2, patients will begin placebo in period 1 and receive CBD in period 2. In Arm 3, patients will receive CBD for the entire 27 week study duration without washout. Each study period is 12 weeks and dose will be titrated up for 1 week at the beginning of a treatment period and titrated down for 1 week at the end of a treatment period, with a two week placebo washout between periods for Arms 1 and 2. The titration dose will be 5mg/kg/day and the treatment dose will be 10mg/kg/day.
15791519|NCT04520672|Other|Blood samples|Blood samples (3 ethylenediaminetetraacetic acid (EDTA) tubes with a volume of 7.5 ml blood each) will be processed for CTC isolation and characterization, ranging from molecular analysis to culture and drug screen.
15791520|NCT04520672|Other|Samples from tumor draining vessels|In case of tumor resection, 3 EDTA tubes (5 ml) will be withdrawn from the tumor draining vessels for CTC isolation and characterization, ranging from molecular analysis to culture and drug screen.
15791521|NCT04520659|Biological|RSV LID/ΔM2-2/1030s|10^5 plaque-forming units (PFU); administered as nose drops
15791522|NCT04520659|Biological|Placebo|Administered as nose drops
15791523|NCT04520646|Drug|Empagliflozin|empagliflozin of 10mg/day is added on the basis of primary care
15791524|NCT04520633|Other|biologic initiation|introduction or modification of biotherapy at M0
15791525|NCT04520620|Drug|Lovenox 40 MG in 0.4 mL Prefilled Syringe|"Patients with a high thrombotic risk:
~In patients with a BMI included between < 30 kg/m² and > 30 kg/m² without added thrombotic risk factor:
~Enoxaparin 40 milligrams, (4,000 IU) twice daily subcutaneously (SC) for the entire duration of the intensive care hospitalization
~if weight > 120 kg, enoxaparin 60 milligrams (6000 IU) twice daily subcutaneously for the entire duration of the intensive care hospitalization
~Patients with a very high thrombotic risk:
~In patients with a BMI > 30 kg/m2 with added thrombotic risk factor (active cancer, recent personal history of thromboembolic event), or if iterative or unusual catheter thromboses, or if marked inflammatory syndrome and/or hypercoagulability (e.g. fibrinogen > 8 g/L or D-Dimer > 3 μg/ml or 3000 ng/ml)
~* Enoxaparin sodium curative at a dose of 100 IU/kg/12h subcutaneously (SC) not to exceed a dose of 100 mg/12 hours"
15791526|NCT04520620|Device|Ultrasound of the lower limbs|A 4-point compression ultrasound will be performed. In case of suspicion, an angiologist will perform to check the absence of legs thrombosis.
15791527|NCT04520607|Drug|Placebo|Healthcare professional-administered intra-articular injection of vehicle.
15791528|NCT04520607|Drug|Lorecivivint|Healthcare professional-administered intra-articular injections of lorecivivint.
15791529|NCT04520594|Other|Resistant Starch|7.5 g resistant starch/m2 oral consumption
15791530|NCT04520594|Other|Placebo|Placebo oral consumption of food-grade cornstarch
15791531|NCT04520581|Other|"group O"|"Endotracheal tube was made O shape by assistants."
15791532|NCT04520568|Combination Product|High flow nasal cannula|using sedation with the HFNC F&P AIRVOTM 2 to maintain oxygenation
15791533|NCT04520568|Combination Product|CONTROL|using general anaesthesia with one lung ventilation (OLV) technique
15791534|NCT04520555|Device|Laryngeal mask airway|LMA Flexible is a supraglottic airway device, which can be moved out of the surgical field without displacement of the cuff, or loss of seal for the anesthetist
15791535|NCT04520555|Device|Endotracheal tube|Endotracheal tube is a plain tube, which is most commonly used in general anesthesia.
15791536|NCT04520542|Other|Acupressure Application|Acupressure was administered in a semi-sitting or supine position where the woman felt comfortable and the researcher could perform the practice comfortably to the acupressure points. The application was performed on the determined acupressure points by considering the direction of the meridian in a certain order. It was performed with the administration order of Spleen 6th point (SP 6) and Large Intestine 4th point (Li 4). In total, the administration was performed with 4 acupressure points including 2 points in the upper/lower extremity along with the parallel points in each intervention.
15791537|NCT04520529|Other|Biologic Samples|"An additional punch from lesion skin as part of a skin biopsy performed as part of routine care.
~an additional blood sample will be collected for research during a blood test performed as part of the patient's routine care.
~In patients with clinical superficial lymphadenopathy or detected by imaging, and undergoing a superficial lymph node biopsy as part of the care, a core biopsy will be dedicated to research."
15791538|NCT04520516|Device|Active VAGUSTIM device|20min/day of stimulation at 25 Hz Frequency, 50 microsec pulse width with intensity escalation up to 15 mA or below in case of auricular discomfort
15791540|NCT04520503|Drug|Propofol|The dose of propofol required for loss of consciousness and the total induction dose of propofol will be recorded for every patients.
15791541|NCT04520503|Device|EEG monitoring|The processed EEG spectrogram and indices, such as patient status index, 95% spectral edge frequency, and suppression ratio, will be obtained from Sedline monitoring device. The raw pre-induction EEG will be extracted from Sedline at the end of induction and it will be analyzed by an external software to calculate the mean frequency, frequency band power and its distribution.
15791542|NCT04520490|Behavioral|Family Based Behavioral Treatment|Children with obesity accompanied by at least one parent or caregiver will attend 24 weekly sessions. Most sessions will be held via video-conference and include 25-30 min. meetings between an interventionist and each child/parent pair to individualize treatment, followed by separate child and parent group meetings lasting 40 - 45 min. A select few sessions will be held in-person between an interventionist and each child/parent pair with no group session. Parents will serve as primary agents of change for their child and for themselves. Training will focus on food and physical activity education, parenting around food and physical activity, and use of behavioral skills (e.g., self-monitoring, environmental control, contingency management). Intervention groups of 8-12 children/families will be initiated every 3-6 mos. in study yrs. 2-3.
15791543|NCT04520490|Drug|Exenatide 2 mg [Bydureon]|Weekly injections of active drug.
15791544|NCT04520490|Drug|Placebo|Weekly placebo injections
15791545|NCT04520477|Diagnostic Test|Bio Impedance assesement (BIA)|BIA every 5 minutes od the test protocol. Patients stood up for 5 minutes, laid down for 70 minutes, followed by 5 minutes in a seated position and ending with 30 minutes standing. BIA was done every 5 minutes.
15791546|NCT04520477|Diagnostic Test|Blood and salava sample|Blood Samples were done at the initation of the protocol, and every 10 minutes after ingestion of the deutarated water
15791547|NCT04520477|Dietary Supplement|Ingestion of deuterated water|15 minutes after the intiation of the test protocol, participants drink an amount of deuterated water corresponding with 0.25% of their TBW calculated using the Watson Formula
15791548|NCT04520477|Diagnostic Test|Urine sample|A urine sample is taken at the initiation and after termination of the protocol.
15791549|NCT04520464|Diagnostic Test|Cervical samples for identification of HR-HPV DNA via real-time PCTR.|Identification of HR-HPV DNA via real-time PCTR.
15791550|NCT04520451|Drug|rilzabrutinib|oral small molecule BTK inhibitor
15791551|NCT04520451|Drug|Glucocorticoids|corticosteroid, anti-inflammatory, or immunosuppressant
15791552|NCT04520438|Procedure|Leukocyte and platelet rich fibrin|L-PRF membrane and irrigation with L-PRF exudate in the same treatment session of NSPT
15791553|NCT04520438|Procedure|Non-Surgical Periodontal treatment|The control group only received NSPT (scaling and root planing) in one treatment session.
15791554|NCT04520425|Procedure|Osteopathic manipulative therapy|"Mandibular: the clinician applies gentle pressure bilaterally to the subject's mandible, in the direction of the patient's clavicles.
~Frontal: the clinician applies gentle pressure bilaterally to the subject's forehead, in a direction halfway between the parietals and ears.
~Temporal: the clinician applies gentle pressure bilaterally to the subject's temples, in the direction of the patient's occiput.
~Parietal: the clinician applies gentle pressure bilaterally to the subject's parietal bones, in the direction of the patient's occipital atlanto joint.
~Occipital: the clinician applies gentle pressure to the subject's occipital bone, in the direction of the patient's neck."
15791555|NCT04520412|Drug|GV-971|Administered PO
15791556|NCT04520412|Drug|Placebo|Administered PO
15791557|NCT04520399|Other|none intervention|there is no intervention in this study
15791558|NCT04520386|Drug|OMT-111|Pre-filled Syringe
15791559|NCT04520373|Other|Best Medical Management: Occupational and Physical Therapy|Observation while undergoing Occupational and Physical Therapy for 6 months
15791560|NCT04520373|Biological|Autologous, Adipose Derived Mesenchymal Stem Cells|The mesenchymal stem cells will be collected and expanded from the patients' adipose tissue.
15791561|NCT04520360|Drug|Carisbamate|Carisbamate is currently under investigation as an adjuvant antiepileptic therapy in Lennox-Gastaut patients. Lennox-Gastaut syndrome (LGS) is a rare and highly debilitating form of childhood epilepsy that typically is diagnosed between 2 and 8 years of age, with peak onset at 3 to 5 years of age, and frequently persists into adulthood. Treatment options are limited and complicated by the multiple seizure types associated with LGS. Given the breadth of physical and cognitive disabilities associated with LGS, the development of antiseizure medications with appropriate oral dosing forms is needed to ensure administration feasibility and compliance in the target population.
15791562|NCT04520334|Other|Zhineng Qigong intervention|"The intervention consisted of group activities which were performed in one group, as lectures, demonstrations, and Zhineng Qigong training, all planned and led by European Zhineng Qigong.
~The group activities were performed during four weekends (12 hours each) and weekly training two times per week (each for two hours). Introductory lecture (two hours) was given at the evening before the first weekend. The respondents were recommended daily Zhineng Qigong training with help of an instructional training CD."
15791563|NCT04520321|Drug|TTHX1114(NM141)|engineered FGF-1 delivered intracamerally
15791564|NCT04520321|Other|Vehicle (placebo)|Placebo
15791565|NCT04520308|Drug|Dupilumab Only Product|SC injections of 300 mg dupilumab every 2 weeks for 24 weeks following a loading dose of 600 mg on day 1
15791566|NCT04520295|Genetic|ctDNA screening|Molecular events including gene mutation, fusion and amplification will be detected by next generation sequencing platform (OncoScreen Plus panelTM) using ctDNA collected from peripheral blood samples of gastric cancer patients. For HER2 positive patients, samples will be collected at baseline, first surveillance after treatment and disease progression. For HER2 negative patients, samples will be collected at baseline as negative control.
15791567|NCT04520269|Drug|Pacritinib|3+3 design Dose Level 1 :200mg BD every 4 weeks Dose Level -1 :200mg OM, 100mg ON every 4 weeks Dose Level -2 :100mg BD every 4 weeks
15791568|NCT04520256|Behavioral|Online Behavioral Weight Loss Program|A self-guided, online program that helps participants reduce energy intake and gradually increase physical activity.
15791569|NCT04520256|Behavioral|Virtual Reality for Behavioral Weight Loss Skills Training|This program allows participants to practice behavioral weight loss skills using an online virtual reality system accessed via a Web browser.
15791641|NCT04519671|Drug|Mesenchymal Stem Cells|Direct injection of adult allogeneic bone marrow derived mesenchymal stem cell product, at a dose of 75 million cells into perianal fistula(s)
15791570|NCT04520256|Behavioral|Tailored Interactive Video Feedback|Video-recorded messages are used to provide periodic feedback on progress with weight loss, dietary change, and physical activity. Additional videos provide dietary skills training.
15791571|NCT04520256|Behavioral|Tailored Intervention for Structured Physical Activity|Periodic self-assessment is used to guide selection of a physical activity goal. Home-based instructional videos are provided to help meet the selected goal.
15791572|NCT04520256|Behavioral|Skills Training for Dysregulated Eating|Periodic self-assessment is used to guide selection of skills training modules designed to counter common causes of dysregulated eating (e.g., boredom, stress).
15791573|NCT04520256|Behavioral|Platform for Social Support & Friendly Competition|An online platform is provided for participants to connect with each other, support each other, and compete on achievement of behavioral and weight loss milestones.
15791574|NCT04520243|Diagnostic Test|Visual acuity assessment by ETDRS charts|All participants must complete VA measurement of both eyes using 2 charts including the ETDRS letters chart and ETDRS numbers chart.
15791575|NCT04520230|Drug|Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid|inhaled corticosteroid (ICS)plus long acting B2-agonist (LABA) (Budesonide/Formoterol combination 160/4.5 mcg, 2 inhalations bid ).
15791576|NCT04520230|Drug|Tiotropium 18 mcg capsule inhaled once daily + Budesonide|inhaled corticosteroid (ICS) plus long acting anticholinergic (LAAC) (Tiotropium 18 mcg capsule inhaled once daily + Budesonide ).
15791577|NCT04520230|Drug|Formoterol/Tiotropium|long acting B2-agonist (LABA) plus long acting anticholinergic (LAAC).
15791578|NCT04520217|Drug|4% Imipramine Cream|4% Imipramine Cream
15791579|NCT04520217|Drug|Base Cream|Base Cream
15791580|NCT04520178|Drug|5-Hydroxytryptophan 100 MG|100mg combined with 50mg carbidopa
15791581|NCT04520178|Drug|5-Hydroxytryptophan|50mg combined with 50mg carbidopa
15791582|NCT04520178|Drug|Carbidopa|50mg
15791583|NCT04520178|Drug|Placebo|Placebo
15791584|NCT04520152|Device|FreeFlowMedical Lung Tensioning Device|Bronchoscopic lung tensioning device implantation
15791585|NCT04520139|Drug|N-Acetyl-Cysteine|Given PO
15791586|NCT04520139|Other|Placebo|Given PO
15791587|NCT04520126|Dietary Supplement|Olivomed (capsules containing hydroxytyrosol)|patients with stable coronary artery disease will be randomised to Olivomed or placebo for three months and then they will be crossed over to the alternate treatment for three months.
15791588|NCT04520113|Behavioral|Household contact tracing|Household contact tracing to test and diagnose Tuberculosis of household contacts of Tuberculosis patients.
15791589|NCT04520100|Behavioral|Clinical Hypnosis performed by the PI|The patient will receive clinical hypnosis by the PI prior to examination and listen to recorded session during their MRI.
15791590|NCT04520100|Behavioral|Care by technician trained in empathic communication|The patient will be taken care of by an MRI technician who has been previously trained in empathic communication.
15791591|NCT04520087|Procedure|allograft fixation|Patients with anteroinferior shoulder instability will be clinically treated with a mini-open arthrotomic technique involving the fixation of the corticospongeous bone graft on the glena.
15791592|NCT04520074|Drug|Etoposide, Cyclophosphamide, Carboplatin/Cisplatin|CTX 400mg（250mg/m2）+VP-16 100mg (70mg/m2)d1-d3 iv 4w/6cycles , CBP(AUC=5) d1/CDDP 30mg/m2 d1-d2+CTX 600mg(400mg/m2)d1-d2 iv 8w/6cycles
15791593|NCT04520061|Behavioral|Health Insurance Navigation Program|The program will be delivered via videoconferencing by a navigator over a 2-month period and will consist of 4 sessions. The navigation intervention sessions will be as follows: Session 1- Learning About Survivorship Healthcare Needs; Session 2- Learning About Your Plan in Relation to Policy; Session 3- Navigating One's Own Plan and Overcoming Obstacles; Session 4- Managing Care Costs.
15791594|NCT04520048|Procedure|Laser Doppler coupled with acetylcholine iontophoresis|Endothelium-dependent vasodilation measured by Laser-Doppler flowmetry coupled with transdermal administration of acetylcholine by iontophoresis
15791595|NCT04520048|Procedure|Aortic central pressure and the carotid-femoral pulse wave velocity|Measurement of the aortic central arterial pressure (systolic and diastolic arterial pressure) by applanation tonometry, and the index of aortic increase by applanation tonometry, the carotid-femoral pulse wave velocity using the SphygmoCor® system (PWV Medical)
15791596|NCT04520048|Other|Vascular biomarker assay|Plasma biomarker levels determination using an immunoassay, including circulating sFlt-1, circulating PIGF, sFlt-1 / PIGF ratio, circulating VEGF, circulating soluble endoglin (sEng), anti-angiotensin II receptor (AT1), circulating copeptin, circulating interleukin 17 (IL-17). Urinary Neutrophil Gelatinase-Associated Lipocalin (NGAL) quantification as well as the urinary endothelial microparticules measurements using flow cytometry
15791597|NCT04520035|Drug|camrelizumab|Carilizumab 200 mg, every 3 weeks, 2 cycles.Paclitaxel 175 mg / m2, D1, every 3 weeks, 2 cycles
15791598|NCT04520035|Drug|Paclitaxel|Cisplatin 75mg / m2 D1, conventional hydration for 3 days, every 3 weeks, 2 cycles
15791599|NCT04520035|Drug|Neoadjuvant Chemotherapy|Neoadjuvant Chemotherapy
15791600|NCT04520022|Drug|Human Umbilical Cord Blood-derived Mesenchymal Stem Cells|3.0 x 106 cells/kg, IV, Total of 3 doses every 2weeks
15791601|NCT04520009|Behavioral|Activity Restriction|Standard post-operative activity instructions (i.e., no bending, twisting, or lifting more than 10 lbs for 4 weeks, no return to work until cleared to do so).
15791602|NCT04520009|Behavioral|Activity as Tolerated|Instructions advising activity as tolerated and return to work based on patient discretion
15791603|NCT04519996|Procedure|US Internal Jugular Vein Collapsibility Index measurment|"Machine
~A sonosite M-Turbo ultrasound machine will be used for all the examinations. A curvilinear USG probe for IVC imaging (1-5 MHz, 21 mm).
~The US transducer will be placed on the right side of the neck in the transverse plane over RIJV 2 cm above the sternoclavicular joint. The IJV will be identified by the color flow Doppler and compressibility. Care will be taken not to compress or obliterate the vein by applying minimal pressure. When the whole circumference of the vein will be visible the measurements were done. The recordings will be done for four respiratory cycles. The maximum, minimum AP diameters, and cross-sectional area will be estimated and, from this, corresponding CI will be derived (Maximum diameter or cross-sectional area (CSA)-minimum diameter or CSA/maximum diameter or CSA) ×100%. All the above measurements will be repeated with the head end of patients elevated to 30° position."
15791642|NCT04519671|Other|Placebo|Normal saline
15791643|NCT04519658|Drug|CIN-107|CIN-107 tablets by mouth once daily
15791604|NCT04519996|Procedure|US Inferior Vena Cava Collapsibility Index measurment|"Machine
~A sonosite M-Turbo ultrasound machine will be used for all the examinations. A linear vascular transuder for IJV imaging (7-13 MHz, 38 mm) will be used.
~The transducer will be placed in the subxiphoid region in a longitudinal position. IVC measurements will be made just distal to the IVC-hepatic vein junction, approximately 3 to 4 cm distal to the right atrium. The IVC will be identiﬁed by Doppler waveform, compressibility and phasic collapse with respiration. The maximum (IVCD) and minimum (IVCD) internal anteroposterior (AP) diameters of the IVC at the end of expiration and inspiration respectively over the same respiratory cycle will be measured. The IVCCI is derived from the equation, IVCCI= (IVCD max -IVCD min)/IVCD max × 100."
15791605|NCT04519983|Drug|Osimertinib Oral Tablet|Osimertinib 80 mg p.o. qd+ SRT(32-40 Gy/4-5f)
15791606|NCT04519970|Behavioral|Case Management|Each tier will have a different level of case management and support, all with the goal of increasing adherence to Biktarvy for HIV management.
15791607|NCT04519944|Drug|Edoxaban|This is an observational, prospective study; no treatment will be administered.
15791608|NCT04519931|Other|Stress ball|The stress ball is a toy, usually no larger than 7 cm. It is used to relieve stress and muscle tension. Stress ball is one of the cognitive and behavioral therapy methods used in pain control. Stress ball is used as a method of diverting attention during painful procedures. It appears to reduce pain and anxiety.
15791609|NCT04519918|Behavioral|AOA|AOA represents an invasive non-physiological technique.
15791610|NCT04519905|Drug|Paclitaxel plus carboplatin|Paclitaxel （45mg/m2) plus carboplatin (AUC=2); five cycles; qw
15791611|NCT04519905|Radiation|radiotherapy|Different radiotherapy dose in different groups.
15791612|NCT04519892|Other|PDRC|Personalized depression risk communication.
15791613|NCT04519892|Other|Coach guidance|Coaching service to guide the understanding of PDRC and answer questions.
15791614|NCT04519879|Other|Clinical Observation|Undergo clinical observation
15791615|NCT04519879|Other|Patient Observation|Undergo active surveillance
15791616|NCT04519879|Other|Questionnaire Administration|Ancillary studies
15791617|NCT04519879|Drug|White Button Mushroom Extract|Given PO
15791618|NCT04519866|Other|Electroacupuncture|"Manual acupuncture (see procedures below) will be administered first to obtain the de qi sensation. After de qi is obtained, the electroacupuncture unit will be connected to 1-3 pairs of acupoints. Current intensity used will be based on the tolerance of each patient. Needles with electrical stimulation will be retained for 30 min.
~Main acupoints will be Jingjin points (meridian sinews) along the Bladder meridian of Foot - Taiyang, such as Shenshuci, as well as Jingjin points (meridian sinews) at transverse process from L2 to L4, iliac crest and spinous process from S1 to S4. Secondary acupoints will also be selected based on patients' syndromes and symptoms."
15791619|NCT04519866|Other|Manual acupuncture|"After disinfecting the acupuncture points, acupuncture will be performed with the patient lying prone. Depending on the acupuncture points, 0.25mm X 25-75 mm sterile acupuncture needle will be used. Needles will be inserted 10-50 mm and either rotating manipulation or lifting-thrusting manipulation will be used to achieve de qi (a compositional sensation including soreness, numbness, distention and heaviness).
~Acupoints used will be similar to those mentioned for electroacupuncture (see above)."
15791620|NCT04519853|Behavioral|Low Glycemic Load Diet|Food delivery service will provide a low glycemic load diet for 8 weeks
15791621|NCT04519840|Other|nill|nill
15791622|NCT04519827|Other|New Rice-based hydrolysate|A rice-based hydrolysed infant formula with new ingredient
15791623|NCT04519827|Other|Amino Acid-based infant formula|An amino acid-based infant formula
15791624|NCT04519814|Procedure|selective laser trabeculoplasty (SLT)|Treatment will be performed on Day 0 using the VISULAS green with Option CSLT for SLT treatment and a mirror goniolens to visualize the trabecular meshwork. The initial energy level is set according to the grade of angle pigmentation and bubble formation. Approximately one hundred non-overlapping lesions will be applied in a single session to 360° of the trabecular meshwork.
15791625|NCT04519801|Other|Blood Flow Restriction (BFR) therapy|BFR therapy beginning 1-week after ACL reconstruction with quadriceps tendon autograft.
15791626|NCT04519801|Other|Standard REHAB|Standard post-operative rehabilitation regimen (REHAB) beginning 1-week after ACL reconstruction with quadriceps tendon autograft.
15791627|NCT04519788|Drug|AT-301B|Nasal Spray
15791628|NCT04519788|Drug|AT-301A|Nasal Spray
15791629|NCT04519775|Behavioral|Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH)|HOBSCOTCH is a home-based self-management program to treat cognitive symptoms and improve quality of life, while minimizing the barriers of access to care. The program is based on Problem Solving Therapy (PST) and teaches problem solving strategies and compensatory mechanisms to help manage cognitive dysfunction and enhance quality of life.
15791630|NCT04519762|Drug|Glycophos (Sodium Glycerophosphate)|Management of hypophosphatemia via Glycophos Management of severe sepsis/septic shock via fluid therapy, antibiotics, vasopressors and inotropics.
15791631|NCT04519762|Drug|Antibiotics|Management of severe sepsis/septic shock via fluid therapy, antibiotics, vasopressors and inotropics.
15791632|NCT04519762|Drug|Inotropes|Management of severe sepsis/septic shock via fluid therapy, antibiotics, vasopressors and inotropics.
15791633|NCT04519749|Biological|4D-310|4D-310 is a novel adeno-associated virus (AAV) gene therapy comprised of two active components: the capsid (4D-C102) and the transgene cassette, which encodes a codon-optimized full length human GLA transgene driven by the CAG promoter. 4D-310 has been engineered so that it cannot replicate (replication incompetent).
15791634|NCT04519736|Device|Single Band vs. Dual Band Pulsed Light Technology for the Treatment of Photodamage|
15791635|NCT04519723|Device|Assess the safety and efficacy of light-laser therapy using the Harmony XL and Dye-VL (500-600nm), Q-Switched 1064nm, Er:YAG 2940nm modules in combination .|
15791636|NCT04519710|Biological|o receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis B|to receive treatment with anti-CD20 (rituximab or ocrelizumab) and to be vaccinated against hepatitis B
15791637|NCT04519697|Drug|Mesenchymal Stem Cells|Adult allogeneic bone marrow derived mesenchymal stem cells for the treatment of rectovaginal fistulas in the setting of Crohn's disease.
15791638|NCT04519697|Other|Placebo|Normal Saline
15791639|NCT04519684|Drug|Mesenchymal stem cells|Allogeneic bone marrow derived mesenchymal stem cells
15791640|NCT04519684|Other|Placebo|Normal Saline
15791648|NCT04519632|Other|Qualitative study|Qualitative interviews
15791650|NCT04519606|Procedure|Optimal lung compliance during OLV|Stepwise increase of tidal volume from 4 ml/kg PBW to 7 ml/kg PBW during OLV to determine the optimal tidal volume at the level the the pressure-volume loop reaches upper refection point where the peak airway pressure at or just below 30 cmH2O
15791651|NCT04519593|Procedure|Laparoscopic myomectomy with prior temporary uterine blood supply occlusion|Visualization and temporary bilateral clipping of uterine/internal iliac arteries and suspensory ligaments of ovaries.
15791652|NCT04519593|Procedure|Conventional laparoscopic myomectomy|Laparoscopic myomectomy without prior temporary uterine blood supply occlusion
15791653|NCT04519580|Diagnostic Test|PET/CT|FDG-PET/CT at baseline, week 8 and week 10.
15791654|NCT04519567|Biological|CTI-1601|CTI-1601 is a recombinant fusion protein and is intended to deliver human frataxin, the protein deficient in Friedreich's ataxia
15791655|NCT04519567|Biological|Placebo|Placebo Comparator
15791656|NCT04519554|Device|Endometrial sampling|Endometrial sampling with 2 different forceps
15791657|NCT04519541|Device|Non-Invasive Thermal Ablation of the Medial Branch Nerves using the Neurolyser XR|Thermal ablation of the medial nerve branch using High Intensity Focused Ultrasound
15791658|NCT04519528|Other|DENVER scale (under 2 years old) or Pediatric Cerebral Performance Category (PCPC) score (over 2 years old)|"The DENVER II is a measure of developmental problems in young children. It was designed to assess child performance on various age-appropriate tasks and compares a given child's performance to the performance of other children the same age. The instrument consists of 125 tasks, which broadly reflect the following areas: personal-social, fine motor-adaptive, language, and gross motor.
~The target population corresponds to infants and pre-school age children.
~The POPC and PCPC are global scales based on observer impressions. Scores include 1 for good, 2 for mild disability, 3 for moderate disability, 4 for severe disability, and 5 for vegetative state or coma (6 indicates death)."
15791659|NCT04519528|Other|Pediatric Quality of Life Inventory™ (PedsQL)|"The PedsQL questionnaire is a modular approach to measuring health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions. The PedsQL Measurement Model integrates seamlessly both generic core scales and disease-specific modules into one measurement system. Twenty-three items divided into different functional areas are evaluated: physical (8 items), emotional (5 items), social (5 items) and school (5 items over 4 years old; 3 items before 4 y.o).
~Child self-report and parent proxy report formats of the questionnaire allows self-assessment of child over 5 years old and parents' evaluations. Items can be reverse and linearly transformed to a 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0) with higher scores indicating better quality of life."
15791660|NCT04519515|Device|Allergan Vollure|Injection of Allergan Vollure into Atrophic Scars
15791661|NCT04519489|Device|PAP therapy with telemonitoring|This study intends to investigate effect of PAP therapy on reducing AF recurrence rate in the patients in co-morbidity of OSA. The study will use 2 investigational devices: Philips DreamStation and Philips EncoreAnywhere. Philips DreamStation is used as the PAP therapy device to provide PAP therapy on the study subjects; Philips EncoreAnywhere is used as a telemonitoring service to provide monitoring by physicians that ensure good adherence to PAP. In addition, subjects in the intervention group will also receive AFib standard management and OSA general care.
15791662|NCT04519489|Other|AF standard management and OSA general care|Subjects in the control group will receive AF standard management and OSA general care. The treatment, medical care, and AF management for the subjects will be performed at the study hospitals following the newly updated Chinese AF management guideline 'Current knowledge and management recommendations of atrial fibrillation: 2018'.All subjects including the intervention group and the control group will receive the education materials to understand the disease, risk, and management of OSA. All subjects will also receive the general intervention for OSA, including suggestions for body weight control, smoking cessation, alcohol limiting, lateral position sleep, etc.
15791663|NCT04519476|Drug|Selinexor|Selinexor (KPT-330) is a first-in-class, oral selective exportin 1 (XPO1) inhibitor (1,2). Selinexor functions by binding with and inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus along with inhibition of translation of oncoprotein mRNAs.
15791664|NCT04519476|Drug|Lenalidomide|Immunomodulatory drug
15791665|NCT04519476|Drug|Methylprednisolone|Glucocorticoid, steroid
15791666|NCT04519463|Drug|Xylocaine Mucosal Product|Xylocaine 10% Nasal Spray
15791667|NCT04519463|Drug|Placebo|Sodium Chloride 0.9%
15791668|NCT04519450|Device|Mindray TE7 ultrasound machine|The study was performed using a Mindray TE7 ultrasound machine with the depth of the linear probe at 70 mm and gain of 90 dB; settings remained unchanged during the study. Measurements of the right m. sternocleidomastoideus, the right m. trapezius, and the right upper leg were taken, with the final value being the average of three measurements for each. The probe was set at the musculoskeletal ultrasound setting.
15791669|NCT04519437|Drug|REGN10933+REGN10987|Administered subcutaneous (SC) every 4 weeks (Q4W)
15791670|NCT04519437|Drug|Placebo|Administered subcutaneous (SC) every 4 weeks (Q4W)
15791671|NCT04519424|Biological|CSL324|Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody
15791672|NCT04519424|Drug|Placebo|Normal saline (0.9% sodium chloride)
15791673|NCT04519411|Diagnostic Test|Transpulmonary pressure measurements|Transpulmonary pressure measurements
15791674|NCT04519398|Genetic|Complete thrombophilic profile testing by multiplex PCR|"Complete thrombophilic profile testing by multiplex PCR and reverse hybridization of DNA to assess the presence of prothrombotic genotypes:
~Factor V Leiden
~Factor V 4070 A>G (Hr2)
~Factor II G20210A
~Methylenetetrahydrofolate reductase (MTHFR) C677T
~MTHFR A1298C
~Cystathionine β-synthase (CBS) 844ins68
~PAI-1 4G/5G
~Glycoprotein IIIa T1565C (HPA-1a/b)
~ACE-DEL/INS
~Apolipoprotein E (ApoE)
~AGT M235T
~Angiotensin II type 1 receptor (ATR-1) A1166C
~Fibrinogen - 455 G>A
~Factor XIII Val34Leu"
15791677|NCT04519372|Diagnostic Test|Testing for SARS-CoV-2|All Patients admitted to the hospital were routinely tested for SARS-CoV-2 within 72 hours of admission by nasopharyngeal swabs.
15791678|NCT04519359|Other|Stop NAs therapy|Stop NAs therapy
15791679|NCT04519346|Other|intradermal injection|Mesotherapy was performed by an experienced and trained physician using disposable 4 mm and 6 mm long 30 Gauge needles (Meso-relle, Biotekne SRL, Italy)to the pericarotid region, glabella, and the area between the eyes and ears, and to the area of the head where pain occurred (such as frontal, parietal, occipital region) for each patient
15791680|NCT04519333|Procedure|drug(intradermal injection)|"The mesotherapy was performed by an experienced and trained physician using a disposable 4 mm and 6 mm long, 30 Gauge needles. Initially, a pharmacological mixture of 1 cc (2 mg) thiocolchicoside, 1 cc (16.2 mg) lidocaine and 1 cc (5 mg) tenoxicam was prepared for each treatment session, and 0.1-0.2 cc of this mixture was applied to each injection point with a depth of 1-3 mm using point by point intradermal method without causing papules.
~In the systemic therapy group, we applied a 50 mg dexketoprofen (Revafen, Haver Pharma Pharmaceutical Co., Turkey) in 100 cc isotonic solution intravenously for 5 minutes."
15791681|NCT04519320|Diagnostic Test|Pulmonary function testing|"D0: date of first symptoms of SARS-COV-2
~M3: D0 + 3 months
~Blood test
~Blood gases
~Clinical examination
~CT Scan
~Pulmonary function testing (PFT)
~6-minute walk test (6MWT)
~MOS SF-36 Questionnaire
~HADS scale
~Ventilatory polygraphy
~M6: D0 + 6 months
~Clinical examination
~PFT
~6MWT
~MOS SF-36 Questionnaire
~HADS scale
~M12: D0 + 12 months
~Blood test
~Blood gases
~Clinical examination
~CT Scan (If anomaly found at M3)
~PFT
~Pulmonary Exercise Stress Test
~6MWT
~MOS SF-36 Questionnaire
~HADS scale
~Subsequent follow-up will be performed only in patients with an alteration defined by a DLCO <LLN and / or an abnormality objectified at CT-Scan attributable to SARS-CoV-2.
~M24, M36, M48 and M60: D0 + 24, 36, 48, 60 months
~Clinical examination
~PFT
~6MWT
~MOS SF-36 Questionnaire
~HADS scale"
15791684|NCT04519281|Drug|IV of vitamin C|administration of high-dose of IV vitamin C perioperatively
15791685|NCT04519268|Diagnostic Test|Adult patients scheduled for an elective general surgical operation.|"The anesthesiologist, who is in charge of preoperative assessment at each hospital unit, will assess patients who are scheduled for elective surgery; and will inform senior anesthesiologists (with a minimum 3 years of experience) & consultant anesthesiologists, about the patients' data.
~Patients data with all requested preoperative investigations & required preparations, peri-operative course and post-operative outcome will be collected."
15791686|NCT04519242|Procedure|Surgery|"ORIF will be done by using bridge plate (variable angle locking plate and/or locking plate and/or dynamic compression plate - 3.5mm, 2.7mm or 2.4mm) and/or transarticular screw osteosynthesis (4.0mm cannulated screws and/or solid small fragment screws and/or HCS). For fixation TMT4 and/or TMT5 K-wires (1.6 or 2.0mm) can be used instead.
~PA will be done by removal of articular surface and subsequent stabilization with bridge plate (variable angle locking plate and/or locking plate and/or dynamic compression plate - 3.5mm, 2.7mm or 2.4mm) and/or transarticular screw osteosynthesis (4.0mm cannulated screws and/or solid small fragment screws and/or HCS).
~Type and sequence of fixation of the involved rays as needed, partial or complete fixation as needed, judgement by treating surgeon."
15791687|NCT04519229|Behavioral|Child-Parent Psychotherapy|Relationship-based trauma focused psychotherapy for Children 0-6 years old and their caregivers. The objective is to decrease symptoms of post-traumatic tress and re-establish a secure attachment for the child and good caregiving from the caregiver/s.
15791688|NCT04519216|Behavioral|Telesimulation|Telesimulation educational intervention
15791689|NCT04519203|Device|SPI|Either standard monitoring alone or added with SPI
15791690|NCT04519203|Device|Standard|Standard monitoring alone
15791691|NCT04519190|Diagnostic Test|Prolonged continuous single-lead ECG monitor|We use Smartpatch, a listed ambulatory electrocardiographic system that can continuously record and save patients' cardiac rhythm for up to 45 days.
15791692|NCT04519190|Diagnostic Test|Intermittent ECG monitor|When using Smartpatch, we can set time markers by pressing the button on the device. We ask our subjects to press that button twice a day and also when they feel any discomfort. Analyzing the ECG 1 minute after those time markers can serve as a surrogate for intermittent ECG monitor.
15791693|NCT04519190|Diagnostic Test|Routine practice|Perform pulse palpation and also ECG if irregular rhythm is found.
15791694|NCT04519177|Behavioral|Sleep Health Education Program (SHEP)|Sleep Health Education Program (SHEP) including screening for common sleep disorders
15791695|NCT04519164|Drug|Eplerenone|mineralocorticoid receptor antagonist and potassium-sparing diuretic
15791696|NCT04519164|Drug|Chlorthalidone with potassium chloride|potassium-wasting diuretic with potassium chloride
15791697|NCT04519151|Drug|Pembrolizumab|200 mg administered by IV infusion on Day 1 of each 21-day cycle.
15791698|NCT04519151|Drug|Lenvatinib|20 mg administered orally (PO) QD during each 21-day cycle.
15791699|NCT04519138|Device|Endodrill Model X|The investigational device Endodrill Model X is used for biopsy sampling in the upper gastrointestinal tract
15791700|NCT04519138|Device|Fine-needle aspiration/biopsy|The standard method is used for biopsy sampling in the upper gastrointestinal tract
15791701|NCT04519125|Drug|Tenofovir/ Emtricitabine ( 300 mg / 200 mg daily during 60 days) + Personal Protective Equipment (PPE)|Tenofovir/ Emtricitabine ( 300 mg / 200 mg daily during 60 days) + Personal Protective Equipment (PPE)
15791702|NCT04519125|Other|Placebo (1 tablet daily during 60 days) + Personal Protective Equipment (PPE)|Placebo (1 tablet daily during 60 days) + Personal Protective Equipment (PPE)
15791703|NCT04519112|Procedure|Catheter Ablation|Catheter Ablation with RMN and MCN
15791704|NCT04519086|Radiation|Low-dose CT|Low-dose computed tomography for suspected acute uncomplicated appendicitis in patients with BMI >30
15791740|NCT04518748|Diagnostic Test|PET/CT|Within 3 hours of completing Y-90 SIRT
15791705|NCT04519086|Procedure|Laparoscopic appendectomy|All patients with BMI >30, who are diagnosed with an uncomplicated acute appendicitis on low-dose CT-scan will undergo laparoscopic appendectomy to evaluate the sensitivity and specificity of the CT diagnosis
15791706|NCT04519073|Biological|V-306 candidate vaccine|"Each V-306 monomer consists of the following elements:
~A Lipopeptide Building Block that contains an optimized, artificially designed coiled-coil domain, which self-assembles into highly stable trimers.
~A 'universal' T-helper epitope fused at the C-terminus of the coiled-coil domain.
~A lipid component di-palmitoyl-S-glyceryl cysteine (Pam2C), fused at the N-terminus.
~A mimetic of the Palivizumab epitope, referred to RSV F-protein site II antigen mimetic (FsIIm), which is coupled near the C-terminus of the Lipopeptide Building Block via a short maleimide-PEG-oxime linker."
15791707|NCT04519060|Device|phototherapy eye shield|Phototherapy eye shields will be applied to the eyes of infants dilated for scheduled eye exam. They will be worn until four (4) hours after the last dose of dilating eye drops.
15791708|NCT04519047|Biological|PRP|Beginning on treatment period, subjects will receive either Rejoint Gel or normal saline with PRP intra-articular injection twice for one month (Visit 3 and 4).
15791709|NCT04519034|Other|no intervention|There will be no intervention
15791710|NCT04519008|Device|Mobile app|Medical device for improving emotion dysregulation
15791711|NCT04519008|Combination Product|Treatment as usual|Bimonthly individual psychotherapy and psychostimulant medications
15791712|NCT04518995|Drug|CTP-543, 8 mg BID|8 mg twice-daily (BID)
15791713|NCT04518995|Drug|CTP-543, 12 mg BID|12 mg twice-daily (BID)
15791714|NCT04518995|Drug|Placebo, BID|Placebo, twice-daily (BID)
15791715|NCT04518982|Drug|Sintilimab and lenalidomide|Drug: Sintilimab 200mg ivgtt on day 1. Drug: lenalidomide 10mg orally once a day, day 1-14.
15791716|NCT04518982|Drug|Sintilimab placebo and lenalidomide placebo|Drug: Sintilimab placebo ivgtt on day 1. Drug: lenalidomide placebo orally once a day, day 1-14.
15791717|NCT04518969|Device|CytoSorb|"CRRT with CytoSorb.Nevertheless , patients will be uniquely in CVVHD mode in order to measure only the CytoSorb Effect.
~First 24 h : the CytoSorb should be changed after 12 h as we forecast a huge cytokine storm in the first 24 hours.
~After the initial 24 h, cartridge change will occur every 24 hours up a maximum of 96 h in total in the inflammation storm persist."
15791718|NCT04518956|Procedure|inter maxillary fixation with shockwave therapy|Shockwave therapy device which give 1500-4000 pulses per session with or without anesthesia, and the treatment session takes approximately 5-10 minutes at the day after surgery.
15791719|NCT04518956|Procedure|Inter maxillary fixation and exposure to low intensity pulsed|Low-intensity pulsed ultra sound was applied three times weekly for six weeks from the second day after surgery.
15791720|NCT04518956|Procedure|Inter maxillary fixation|Closed reduction will be done. Intermaxillary fixation (IMF) will be secured after proper reduction of the fractured segments to assure proper occlusion using upper and lower arch bars or eyelet wires for six weeks.
15791721|NCT04518943|Behavioral|Walking|Inactive Veterans will be encouraged to increase their step count to 7,000 steps per day by the end of the 12-week intervention period. Weekly the step goal will increase 15% if they were successful in reaching their goal the previous week.
15791722|NCT04518930|Other|Peanuts or plain Greek yogurt|Two different types of dietary snacks
15791723|NCT04518917|Behavioral|Mentally Singing|Participants sing their song in their head and match their footfalls to the beat.
15791724|NCT04518917|Behavioral|Listening to music|Participants listen to their song and match their footfalls to the beat.
15791725|NCT04518917|Behavioral|Singing|Participants will sing their song out loud and match their footfalls to the beat.
15791726|NCT04518891|Behavioral|Cognitive Functional Therapy (CFT)|Cognitive functional therapy (CFT) is an intervention that deals with potentially modifiable multidimensional aspects of pain (e.g. provocative cognitive, movement and lifestyle behaviours). Treatment with CFT will be individualised, the physiotherapist will listen to the complete patient pain history and the intervention will be focused on individual needs. A detailed examination will be crucial in identifying the modifiable multidimensional mediators of pain and disability (provocative cognitive, pain, movement and lifestyle behaviors) of each participant.
15791727|NCT04518891|Device|Sham intervention|Due to the impossibility of applying placebo exercise, the control intervention in this study will be based on successful reports of placebo intervention in patients with chronic low back pain in the literature (Placebo photobiomodulation + neutral talking control)
15791728|NCT04518878|Drug|Eltrombopag|Fixed dose of eltrombopag oral 25mg daily
15791729|NCT04518878|Drug|rhTPO|Rh-TPO 300U/kg subcutaneous injection once daily for 7 consecutive days, followed by a tapering dose in maintenance therapy.
15791730|NCT04518865|Device|Herbst appliance|The bottom line of the study is to investigate the changes after Herbst appliance treatment and relate it to the pubertal status of the skeletal class II patients using CBCT.
15791731|NCT04518852|Combination Product|TACE combined with sorafenib and PD-1 mAb|the combination of local therapy (TACE), anti-angiogenic therapy (sorafenib), and immunotherapy (PD-1 monoclonal antibody)
15791732|NCT04518826|Device|fractional flow reserve|FFR is a physiological functional parameter indicating the severity of ischemic myocardium perfused by a diseased coronary artery. It is measured by a pressure wire placed in the coronary artery and calculated by the ratio of pressures distal and proximal to the stenosis.
15791733|NCT04518813|Device|Prototype 0.5|Investigational Medical Device collecting Raman data from tissue
15791734|NCT04518800|Drug|Jin Youli(PEG-rhG-CSF)|Jin Youli(PEG-rhG-CSF) was given 24 hours after the completion of intravenous infusion of albumin paclitaxel during the treatment period, 6 mg was given to patients with body weight ≥45 kg, and 3 mg was given for body weight <45 kg. Inject once every chemotherapy cycle
15791735|NCT04518774|Biological|Ex-vivo expanded allogeneic γδT cells|Cells will be extracted from a healthy donor by apheresis, followed by ex-vivo expansion and activation. The ex-vivo expanded γδT cells from donors will be adoptively transfused.
15791736|NCT04518761|Procedure|Elective surgery|Any patient who needs to undergo an elective surgery.
15791737|NCT04518748|Drug|Yttrium-90|Radioactive isotope Y-90 at day 0, administered by selective internal radiation therapy (SIRT)
15791738|NCT04518748|Device|Selective Internal Radiation Therapy|SIRT at day 0, to administer Yttrium-90 (Y-90) Theraspheres
15791739|NCT04518748|Radiation|Stereotactic Body Radiation Therapy|3-5 fractions over 1-2 weeks, after Y-90 SIRT
15791741|NCT04518748|Device|Therasphere|Glass microspheres containing Y-90, administered at day 0 by SIRT
15791742|NCT04518735|Other|Antithrombotic Therapy (anticoagulant and/or antiplatelet) before admission for Covid19|Review of medical records during hospitalization and until day 28 post-entry to compare the clinical outcomes depending on previous antithrombotic therapy
15791743|NCT04518722|Radiation|CT Scan|Dual-energy mid-tibia CT, high-resolution single energy MDCT imaging of the distal tibia (ankle), and low radiation hip CT scans
15791744|NCT04518722|Radiation|DXA Scan|Basic DXA scans will be performed to measure areal BMD and body composition measures at the whole body, spine, and hip
15791745|NCT04518722|Other|Steroid Intake Questionnaire|Questionnaire designed to quantify lifetime oral glucocorticoid intake
15791746|NCT04518709|Procedure|Posterior Mitral Annulus Elevation Technique|Posterior mitral annulus elevation technique is performed using a large pledget and non-absorbable braided suture starting from the subvalvular section of the posterior mitral valve sutured to the ring annuloplasty (if in the process of repairing the mitral valve, ring implantation is performed; if without the use of ring annuloplasty, the suture is placed in the left atrial wall / supravalvular of PML), so that the posterior annulus is slightly attracted upward toward the cranial and the PML moves toward the center.
15791747|NCT04518709|Procedure|Conventional Mitral Valve Repair|Conventional mitral valve repair in the pediatric patient using annuloplasty, leaflet resection and plication, sliding-plasty of chordae technique
15791748|NCT04518696|Procedure|suprachoroidal buckling|"Location, marking and freezing of the retinal tear on the scleral side . Subretinal fluid is released from the outside of the sclera as needed. In the quadrant of the retinal tear, the spherical conjunctiva was opened and the radial full-thickness scleral incision (3mm)was made about 8-13mm away from the retinal tear. After the choroid was exposed, a pocket is formed by injecting some viscoelastic agent into the posterior edge of the sclera and separating the choroid from the sclera using the Healon packaged cannula (No.27 Rycroft cannula). The Healon 5 syringe was connected with a 450-um special tube . The cannula is inserted into the supragromal space under microscopic and was scaned by iOCT . Once confirmed in accord with the needle position, sodium hyaluronate injection, usually need 0.2 mL to 0.5 mL, application of anterior chamber puncture or subretinal fluid stable intraocular pressure. Exit the duct and close the incision with scleral presutures."
15791749|NCT04518683|Device|Perineal rehabilitation with mobile applications for women with SUI|"Physiotherapy: Sessions with the physiotherapist will consist of information on anatomy, perineal awareness and behavioural therapy. The therapist will educate the patient on pelvic floor contraction/relaxation. the sessions will remain personalized and standardized like a classic treatment, and will also aim to work on motivation. 9 sessions during 3 months.
~Home Program: The home program will be done with a mobile application equipped with a vaginal probe. The exercises should be done 3x/week for 10 minutes. The correct use of the prob will have been checked during the sessions with the physiotherapist. This training will work on the strength, relaxation and endurance of the pelvic floor.The program includes 3 levels of difficulty. Once the user has successfully completed one level, she can move on to the next."
15791750|NCT04518683|Device|Classic perineal rehabilitation for women with SUI|"Physiotherapy: Sessions with the physiotherapist will consist of information on anatomy, perineal awareness and behavioural therapy. The therapist will educate the patient on pelvic floor contraction/relaxation. The sessions will remain personalized and standardized like a classic treatment, and will also aim to work on motivation. 9 sessions during 3 months.
~Home program: The home program will be done without a mobile application. The exercises will have been explained during the sessions with the physiotherapist by oral instructions. The exercises will be done 3x/week for 10 minutes. The correct realization of the exercises will have been verified during the sessions with the physiotherapist."
15791751|NCT04518670|Device|Comaneci Embolization Assist Device|assist in the coil embolization of wide-necked intracranial aneurysms with a neck width ≤ 10 mm.
15791752|NCT04518657|Behavioral|Behavioral Intervention for Physical Activity in MS (BIPAMS)|A behavioral intervention that involves an internet website and one-on-one video coaching calls for increasing physical activity in people with MS.
15791753|NCT04518657|Behavioral|Wellness for MS (WellMS)|A behavioral intervention that involves an internet website and one-on-one video coaching calls for increasing wellness in people with MS.
15791754|NCT04518644|Drug|Nilotinib|The recommended dosing of nilotinib is 400 mg orally twice daily
15791755|NCT04518631|Behavioral|8-week mindfulness program|The .b Foundations course is an 8-week mindfulness program developed by Mindfulness in Schools Project (MiSP) for school teachers and personnel. It includes a taster session and 8 weekly sessions. Each session lasts for 1.5 hours with a specific theme (e.g. Lesson 1 waking up from autopilot). Formal and informal mindfulness practices (e.g. mindful eating, body scan, mindful walking, habit releaser etc.), psychoeducation, cognitive exercises, inquiry, and home practice are involved.
15791756|NCT04518618|Drug|Fentanyl|Spinal anesthesia will be performed with injection of 2.5 ml which will be composed of 10 mg hyperbaric bupivacaine (2 ml) and 25 ugs fentanyl (0.5 ml)
15791757|NCT04518618|Drug|Naloxone|Spinal anesthesia will be performed with injection of 2.5 ml which will be composed of 10 mg hyperbaric bupivacaine (2 ml) and fentanyl 25 ug combined with 20 ugs naloxone in 0.5 ml
15791758|NCT04518605|Dietary Supplement|Low protein breakfast|Low protein yoghurt containing approx. 2 g protein per 100 g. Participants will be asked to consume ~60 g bread, 20 g jam and 250 ml juice for breakfast.
15791759|NCT04518605|Dietary Supplement|High protein breakfast|High protein yoghurt containing approx. 10 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) yoghurt with 40 g oats for breakfast.
15791760|NCT04518605|Other|Exercise training|Participants will be asked to participate in organized exercise training 3 times per week.
15791761|NCT04518579|Procedure|thoracic epidural|undergo insertion of an epidural catheter, between T9 and T11 in patients undergoing left-sided resections and between T8 and T10 in patients undergoing right-sided resections
15791793|NCT04518397|Behavioral|Theatre|6-week participatory arts culturally-informed theatre program
15791794|NCT04518384|Procedure|colon or rectum resection|surgical procedure to resect the colon or rectum
15791762|NCT04518566|Behavioral|Nudges|Behavioral nudges will be delivered to patients' FitBit device through adaptive intervention platform via notification syncing. To ensure the delivered nudges are timely and personalized, predictive nudges will be developed based on patterns in patients' sociodemographic, clinical and baseline activity tracking. These nudges will be sent automatically to patients upon specific triggers. The nudges will also be assessed for its effectiveness in behavior change. For example, a predictive nudge to encourage patients to take a short walk after detecting long periods of sedentary time will be assessed for its effects by step counts data after delivery of nudge. An iterative approach will be used to generate an effective set of nudges and its most appropriate delivery times for specific activity patterns.
15791763|NCT04518553|Drug|active comarator using antiviral drug of nucleoside analogues|using antiviral drug of nucleoside analogues without additional active interference to control Hepatitis B virus.
15791764|NCT04518553|Device|HA+purification|Based on antiviral drug of nucleoside analogues, plasma purification is added to control hepatitis B virus every three months. After three months, plasma purification will continue if hepatitis B virus DNA titer is still higher than cut-off normal value. plasma purification process lasts 2.5-3 hours each session.
15791765|NCT04518540|Drug|lipoic acid group|"The patients will take lipoic acid for 6 course, the first course of treatment is 14 days with 14 days of rest, and the following course is the first for 10 days, with 14 days interval.The patients will use 600mg domestic lipoic acid in 250ml normal saline by intravenous, once a day.
~At the same time, the patients will take domestic riluzole tablets 50mg orally, twice a day."
15791766|NCT04518540|Drug|control group|The patients will take domestic riluzole tablets 50mg orally, twice a day.
15791767|NCT04518527|Device|Tape|The tape is an elastic cotton strip with an acrylic adhesive that is used with the intent of treating pain and disability
15791768|NCT04518514|Device|TAPE-Software|Telemedical Risk Assessment and Preoperative Evaluation prior to anaesthesia via personal computer
15791769|NCT04518501|Drug|Arsenic trioxide Tablet +Fuzuloparib Capsules|Arsenic trioxide Tablet : 0.27*9 tid po consecutive 21 days with 1 week rest． Fuzuloparib Capsules: 150 mg bid po
15791770|NCT04518488|Other|Exercises|Personalized and individualized exercises for lower limb soft-tissue sarcoma of each participant in this group.
15791771|NCT04518488|Other|Informational Support Group (Control group)|The focus for participants in the Informational Support Group will be on needs for information and psychosocial support during the pre-operative period.
15791772|NCT04518475|Drug|eltrombopag combining rituximab|"After enrollment,all subjects receive eltrombopag treatment,the initial dose of eltrombopag administration was an oral 75 mg once daily.Complete blood count including platelet count was done once a week.The dose of eltrombopag was adjusted according to the subject platelet count during the period from week 1 to week 24. If the platelet count >250×10^9/L, the eltrombopag will stop until the platelet count <30×10^9/L.
~All subjects receive single dose infusion of rituximab 375 mg/m(2) within 14 days after enrollment.
~Efficacy and safety will be evaluated at Week 4, Week 8, and Week 12."
15791773|NCT04518475|Drug|eltrombopag|"After enrollment,all subjects receive eltrombopag treatment,the initial dose of eltrombopag administration was an oral 75 mg once daily.Complete blood count including platelet count was done once a week.The dose of eltrombopag was adjusted according to the subject platelet count during the period from week 1 to week 24. If the platelet count >250×10^9/L, the eltrombopag will stop until the platelet count <30×10^9/L.
~Efficacy and safety will be evaluated at Week 4, Week 8, and Week 12."
15791774|NCT04518462|Drug|Exparel|EXPAREL (bupivacaine liposome injectable suspension)
15791775|NCT04518462|Drug|Bupivacaine Hydrochloride|0.25% bupivacaine
15791776|NCT04518449|Procedure|medial border along the left side of SMA|to place the medial border along the left side of SMA in laparoscopic D3 lymphadenectomy for right colon cancer
15791777|NCT04518449|Procedure|medial border along the left side of SMV|to place the medial border along the left side of SMV in laparoscopic D3 lymphadenectomy for right colon cancer
15792032|NCT04516538|Behavioral|Mini Mental State Examination|test for evaluating a person's cognitive functions and memory capacity
15791795|NCT04518371|Other|Reinforced composite for the fabrication of permanent, indirect restorations using a CAD/CAM grinding process.|Shock-absorbing effect due to the dentine-like modulus of elasticity makes BRILLIANT Crios extremely well suited for implant restorations.it is composed of dental glass (barium glass ˂ 1.0 μm), amorphous silica (Sio2 ˂ 20 nm), resin matrix (cross-linked methacrylates) and pigments
15791796|NCT04518358|Behavioral|Use of Expert Guiding Technology (GAINS) to Improve Live and Vocational Skills for Individuals with Developmental Challenges|During the GAINS sessions, the Direct Support Professional (DSP) will follow the pre-programmed teaching protocol in the expert guiding technology. The system will provide step-by-step verbal prompts to the DSP throughout sessions. This includes which prompt to use for each step of the target skill, when to provide reinforcers, and which target task to work on. The system will also monitor the participant's (adults with ASD/ID) progress and notify the DSP if the target skill is mastered.
15791797|NCT04518345|Drug|Azacitidine|Given IV
15791798|NCT04518345|Drug|Dubermatinib|Given PO
15791799|NCT04518319|Drug|Omega-3 polyunsaturated fatty acids|Omega-3 polyunsaturated fatty acids will be taken 1200mg per day plus on olanzapine.
15791800|NCT04518319|Behavioral|Xbox aerobic exercise|Patients will do Xbox aerobic exercise 30min per day plus on olanzapine.
15791801|NCT04518319|Device|transcranial direct current stimulation,tDCS|Patients will receive tDCS at 2mA, 20 min for 5 session per week plus on olanzapine.
15791802|NCT04518319|Drug|Olanzapine|Patients will take only olanzapine pills.
15791803|NCT04518306|Drug|Telmisartan 10 mg/amlodipine 1.25 mg/indapamide 0.625 mg|Oral tablets
15791804|NCT04518306|Drug|Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg|Oral tablets
15791805|NCT04518306|Drug|Placebo|Placebo
15791806|NCT04518293|Drug|Telmisartan 20 mg/amlodipine 2.5 mg/indapamide 1.25 mg|Single pill
15791807|NCT04518293|Drug|telmisartan 40 mg/amlodipine 5 mg/indapamide 2.5 mg|Signle pill
15791808|NCT04518293|Drug|Telmisartan 20 mg/amlodipine 2.5 mg .|oral tablet
15791809|NCT04518293|Drug|telmisartan 40 mg/amlodipine 5 mg|oral tablet
15791810|NCT04518293|Drug|Telmisartan 20 mg/indapamide 1.25 mg|oral tablet
15791811|NCT04518293|Drug|telmisartan 40 mg/indapamide 2.5 mg|oral tablet
15791812|NCT04518293|Drug|Amlodipine 2.5 mg/indapamide 1.25 mg|oral tablet
15791813|NCT04518293|Drug|amlodipine 5 mg/indapamide 2.5 mg|oral tablet
15791814|NCT04518280|Drug|PD-1 antibody|PD-1 antibody (Toripalimab): 240mg d1 q3w
15791815|NCT04518280|Drug|Capecitabine|Capecitabine: 1000mg/m2 d1-14 q3w
15791816|NCT04518280|Drug|Oxaliplatin|Oxaliplatin: 130mg/m2 d1 q3w
15791817|NCT04518280|Radiation|Short-course radiotherapy|Shor-course radiotherapy: 25Gy/5Fx
15791818|NCT04518267|Behavioral|Structured clinical interview|A structured clinical interview will be performed at enrollment.
15791819|NCT04518267|Behavioral|Psychological questionnaires|Several psychological questionnaires will be performed at enrollment.
15791820|NCT04518254|Biological|Blood collection|A blood sample will be collected before and after treatment administration
15791821|NCT04518254|Drug|L-Tyrosine 500 Mg|The participants will be administered 4 capsules of L-Tyrosine 500 mg per oral route
15791822|NCT04518254|Drug|Placebo|The participants will be administered 4 capsules of Lactose 500 mg (placebo) per oral route
15791823|NCT04518254|Behavioral|Cognitive tasks|The participants will perform cognitive decision-making tasks: Simon task and masking task after treatment administration
15791824|NCT04518254|Other|Stress exposure|Unpleasant but not painful skin stimulations will be administered to the participants at variable intervals on the left leg during the cognitive tasks
15791825|NCT04518254|Behavioral|Anxiety scale|Spielberger's State Trait Anxiety Inventory (STAI) will be filled by the participants before and after cognitive tasks
15791826|NCT04518254|Device|Electromyography (EMG)|Electromyography measurements will be performed during cognitive tasks.
15791827|NCT04518254|Device|Electroencephalography (EEG)|Electroencephalography measurements will be performed during cognitive tasks.
15791828|NCT04518241|Behavioral|MI sessions|"Three counseling sessions lasting less than 60 minutes each to identify goals, factors that promote or impede goals, and increase readiness for ART with high adherence"
15791829|NCT04518241|Behavioral|TMQQ|Weekly text messages with health information as well as motivational messages. Two days later a true/false quiz question is sent. Participants earn 4 points for answering correctly, 2 points for answering incorrectly, and 0 points for not answering. Participants earn $1 for each point. Messages are sent over 21 weeks.
15791830|NCT04518241|Behavioral|Type of compensation|Participants who achieve HIV viral suppression at 21 weeks will receive either fixed compensation of $275 or be entered into a lottery where they have a 3/10 chance of winning $500, and a 7/10 chance of winning $175. Those who do not achieve HIV viral suppression receive a $50 participant incentive.
15792279|NCT04514653|Biological|Ranibizumab (LUCENTIS®)|Ranibizumab (anti-VEGF agent)
15791843|NCT04518215|Procedure|Erector Spinae Plain Block|Patients will receive erector spinae plane block (ESP) at the level of T 9-10. Following skin sterilization, high-frequency linear ultrasound probe will be placed 1-2 cm lateral to the midline at the T 9 level. After identification of the erector spinae muscle (ESM) and the transverse process; a 22 G needle will be inserted, in a cranio-caudal direction, deep into the ESM in an in-plane technique. Correct needle placement will be verified with the administration of 0.5-1 ml Normal Saline to view the hydrodissection between the transverse process and the ESM. 0.25% Bupivacaine in a calculated volume of 0.5 ml/kg (with a maximum dose of 20 ml) will be injected deep to the erector spinae muscle for unilateral ESPB.
15791844|NCT04518215|Procedure|Intra-Venous Analgesia|Post-operative rescue analgesic plan will consist of 15 mg/kg Paracetamol IV if the FLACC [Face, Leg, Activity, Cry, Consolability] score is 2-4 and 1 mg/kg Tramadol IV if FLACC score > 4.
15791845|NCT04518202|Drug|lidocaine patch|5% lidocaine patch applied at 6 hours before the scheduled office hysteroscopy.
15791846|NCT04518202|Drug|Sham patch|Sham patch containing no study medication applied at 6 hours before the scheduled office hysteroscopy.
15791847|NCT04518189|Drug|lidocaine patch|lidocaine patch applied 3 hours before the procedure
15791848|NCT04518189|Drug|Sham patch|Sham patch applied 3 hours before the procedure
15791849|NCT04518176|Procedure|bilateral uterine artery ligation|The peritoneum over the vesico-uterine pouch already being incised horizontally, the peritoneum over the uterine isthmus and cervix was dissected downwards, and this dissection was then extended laterally
15791850|NCT04518176|Drug|Oxytocin|20 units by slow intravenous drip injection
15791851|NCT04518163|Drug|Tranexamic Acid|Intravenous 1 gm tranexamic acid in 100 ml saline by slow infusion before skin incision
15791852|NCT04518163|Drug|placebo to TA|Intravenous 110 ml saline by slow infusion before skin incision
15791853|NCT04518163|Device|Bakri Balloon|Bakri balloon was inserted into the lower uterine segment through the uterine incision by passing the balloon shaft through the cervix with an assistant pulling vaginally
15791854|NCT04518150|Device|Bakri balloon|the Bakri balloon was inserted into the lower uterine segment through the uterine incision by passing the balloon shaft through the cervix with an assistant pulling vaginally
15791855|NCT04518150|Procedure|Bilateral Uterine Artery Ligation|The peritoneum over the vesico-uterine pouch already being incised horizontally, the peritoneum over the uterine isthmus and cervix was dissected downwards, and this dissection was then extended laterally.
15791856|NCT04518137|Drug|ATG-008 30 mg, orally, QD, each 4 week (28-day) a cycle|48 patients enrolled will be treated with 30mg QD of ATG-008, orally, each 4 week (28-day) a cycle
15791857|NCT04518124|Drug|Propranolol|Propranolol will be administered as monotherapy in a dose of 40-80 mg 2-3 times a day, if tolerated. The study consists of a single arm.
15791858|NCT04518098|Other|Strength and balance exercise|3-month (3X weekly) supervised resistance and balance training using a exercise resistance bands as well as following routines as outlined by the Otago program.
15791859|NCT04518085|Behavioral|Medical hypnosis|Single session 20 minutes hypnosis session originally developed and tested by Montgomery et al. (2007) in a similar setting. Delivered by an experienced clinical psychologist.
15791860|NCT04518085|Behavioral|Internet-based Acceptance and Commitment Therapy (iACT)|Access to an online platform developed to this study containing video clips and audio files with ACT consistent material
15791861|NCT04518085|Behavioral|Mindfulness session|Single session mindfulness session delivered by audio file
15791862|NCT04518085|Behavioral|Treatment as Usual (TAU)|Treatment as usual as part of post-surical care
15791863|NCT04518072|Other|Blood sample (2 EDTA tube) and urine sample (100 ml)|assessed biomarker in clinical samples,
15791864|NCT04518059|Procedure|punch skin biopsy|An anesthetic medication is injected to numb the areas of skin and two samples of skin are obtained from punch biopsy.
15791865|NCT04518046|Drug|Sitravatinib|Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases
15791866|NCT04518046|Drug|Nivolumab|Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
15791867|NCT04518046|Drug|Ipilimumab|Ipilimumab is a CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) blocking antibody
15791868|NCT04518033|Device|Various commercially available face coverings|Various commercially available face coverings
15791869|NCT04518020|Procedure|40 patients will be randomly allocated to short implants and standard implants in conjunction with MSFA|40 patients will be randomly allocated to short implants (group 1) and standard implants in conjunction with MSFA using 50% particulated autogenous mandibular bone graft mixed with 50% Bio-Oss (group 2).
15791870|NCT04518007|Device|hyperbaric oxygen therapy|"The HBOT protocol consists of 60 daily sessions, five times per week, each session lasting 90 minutes.
~Investigational product:
~Multiplace hyperbaric oxygen chamber (Haux, Germany) located at the Sago l Center for Hyperbaric Medicine and Research, Shamir (Assaf-Harofeh) Medical Center, Israel."
15791871|NCT04517994|Behavioral|Active Treatment|See arm description.
15791872|NCT04517994|Behavioral|Supportive Treatment|See arm description.
15791873|NCT04517981|Behavioral|Psychological intervention|Choose according to the wishes of the enrolled subjects and the results of the evaluation
15791874|NCT04517981|Other|Comprehensive intervention|Choose according to the wishes of the enrolled subjects and the results of the evaluation
15791875|NCT04517968|Other|immediate implant with customized healing abutment|"All patients will be operated under local anesthesia.
~Atraumatic extraction of the remaining root or tooth will be achieved.
~A careful curettage of the socket will be performed if any granulation tissue is present.
~Sequential drilling of the osteotomy site with copious irrigation will be done
~The Implant is secured in place using a torque wrench.
~Fabrication of the customized abutment with flowable composite by first placing a rubber dam between the abutment and the implant to prevent leakage of composite into the socket then start adding the composite in a manner to seal the socket.
~Finishing the composite outside the patient's mouth will be done to ensure the borders are smooth with no sharp ends.
~The abutment will be attached to the implant."
15791876|NCT04517955|Device|Transcatheter Aortic Valve Implantation (TAVI)|Transcatheter Aortic Valve Implantation with Evolut R or Evolut Pro
15791877|NCT04517942|Behavioral|EVERYbody Project|Brief behavioral intervention (4 hours across two meetings)
15791878|NCT04517942|Other|Video + Expressive Writing|Brief video-based intervention (4 hours across two meetings)
15791879|NCT04517929|Other|Group Psychotherapy|9 week group psychotherapy, given by a psychologist trained in group psychotherapy.
15791880|NCT04517916|Device|Zephyr Valve|Subjects prescribed Zephyr Valve treatment for their emphysema/COPD and treated with the Zephyr Valves.
15791881|NCT04517903|Other|eye rubbing questionnaire|eye rubbing questionnaire
15791882|NCT04517890|Drug|lidocaine patch|5% lidocaine patch applied at 3 hours before the procedure
15791883|NCT04517890|Drug|Sham patch|Sham patch containing no study medication applied 3 hours before the procedure
15791884|NCT04517877|Behavioral|Caring Response App|Participants will receive the Caring Light mobile app containing the coping skills training.
15791885|NCT04517877|Behavioral|Traditional Educational/Resources Program|Participants will receive a traditional educational/resources program, containing a workbook and online resources.
15791886|NCT04517864|Drug|PF-06651600|50 mg tablet, dosed as 200 mg QD or 50 mg QD
15791887|NCT04517864|Drug|Placebo|tablet, dosed as 4 tablets QD or 1 tablet QD
15791888|NCT04517851|Biological|Elotuzumab|Given IV
15791889|NCT04517851|Other|Questionnaire Administration|Ancillary studies
15791890|NCT04517838|Procedure|Biospecimen Collection|Undergo collection of blood and tumor tissue samples
15791891|NCT04517825|Diagnostic Test|Cepheid Xpert HIV-1 Viral Load Assay|Rapid, on-site molecular HIV-1 viral load testing used in accordance with cleared/approved labeling
15791892|NCT04517812|Other|Exercise-based games via the VirtualRehab platform|A 12-week exercise-based home rehabilitation intervention delivered via the VirtualRehab platform. A personalised exercise-based rehabilitation plan will be created for each participant.
15791893|NCT04517799|Drug|Epidiolex|"While in the intervention arm subjects will receive EPIDIOLEX, an oral purified CBD solution developed by GW Pharmaceuticals. The formulation is a 100 mg/mL solution, which allows for easy dose titration and administration even to young children. EPIDIOLEX is naturally-derived CBD, and has been found to have a purity of over 98%. The solution includes a sweetener to make it palatable. Dosing is dependent upon each subject's weight.
~The dosage will be titrated over time as follows:
~Week 1: 5 mg/kg/day, divided into 2 doses Week 2: 10 mg/kg/day, divided into 2 doses Weeks 3-8: 20 mg/kg/day, divided into 2 doses If a child's weight changes by greater than 2 kg during the study, the dose will be adjusted to reflect the weight change."
15791894|NCT04517799|Drug|placebo oral solution|"GW has developed a placebo that is identical in color and taste, and will be administered in the same volume as the CBD, so that parents and investigators should not be able to detect differences between the 2 treatments. Dosing is dependent upon each subject's weight.
~The dosage will be titrated as follows:
~Week 1: 5 mg/kg/day, divided into 2 doses Week 2: 10 mg/kg/day, divided into 2 doses Weeks 3-8: 20 mg/kg/day, divided into 2 doses If a child's weight changes by greater than 2 kg during the study, the dose will be adjusted to reflect the weight change."
15791895|NCT04517786|Device|MINIject CS627 implant|"MINI SO627 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant (CS627) and a single operator delivery tool.
~The delivery tool is a single-use tool, designed for inserting the CS627 implant into the suprachoroidal space in the eye."
15791896|NCT04517773|Other|writting test|Patients will be invitated to fill a questionary about self-autonomy
15791897|NCT04517747|Drug|Ramucirumab|chemotherapy i.v.
15791898|NCT04517747|Drug|TAS 102|p.o. twice daily
15791899|NCT04517721|Other|Nurse-Led Transitional Burns Rehabilitation Programme (4Cs-TBuRP)|The nurse-led transitional burns rehabilitation programme (4Cs-TBuRP) is presented as an 8-week interventional programme that supports holistic care for adult burn survivors led by a specialist burn care nurse and supported by the burn care team. The intervention posits that as the adult burn survivor transitions, several physiological, psychosocial, health-related behaviour and environmental needs emerge which lead to poor quality of life. Despite this, they may be unable to return to utilise available healthcare services or have inadequate contact with rehabilitation services. To facilitate their recovery and enhance the attainment of rehabilitation outcomes, the 4Cs-TBuRP views the burn care nurse as the link between rehabilitation services and the adult burn survivor. Thus, the burn care nurse serves as the coordinator of care and actively collaborates with the burn care team and the patient/ family to ensure that continuous care is delivered in a timely manner.
15791900|NCT04517708|Other|Nutritional counseling|Each patient was assigned a specific menu which were prepared by research members during the time of staying at the hospital. Before discharge, patients were instructed on preparing their diets at home with the recommended amount of energy and protein and given formula milk within two months
15791901|NCT04517695|Device|BVA-100|"The BVA-100 is a software package designed to calculate human blood volume using the method of tracer dilution. It uses tagged serum albumin (a commonly used tag is 131I, resulting in 131I -HSA). Data inputs to the software come from the measured characteristics of subject blood samples (hematocrit and tracer concentration) and tracer calibration standards. The package also calculates the subject expected (or ideal) blood volume from physical parameters. Hyper- or hypovolemia, associated red blood cell volumes, and transudation rate are reported, with statistics showing the quality of the results. The subject blood samples and calibration standards are measured in a gamma counter, whose output is automatically, or manually, input to this calculation program."
15791902|NCT04517682|Diagnostic Test|RT-PCR|The RT-PCR assay will be performed on paired nasopharyngeal and saliva samples
15792439|NCT04513327|Other|Conventional Rehabilitation|Home-based self-rehabilitation using brochure for 12 weeks post surgery.
15791903|NCT04517656|Other|Blood samples|"A peripheral blood sample will be taken and will include 2 EDTA tubes of 5 mL, for a total volume of 10 mL:
~Samples before the allograft,
~Samples at different times post-allograft: 15 days, 30 days, 60 days, 90 days, 180 days, 360 days,
~Samples in the event of the occurrence of concomitant events during the 12-month follow-up period: occurrence of acute Graft Versus Host Disease, chronic Graft Versus Host Disease, or relapse of the disease before the initiation of a new treatment."
15791904|NCT04517643|Other|Therasphere Therapy|TheraSphere is a radiotherapy treatment for primary and secondary liver neoplasia. This is an imaging study that will examine 3-5 patients who have been treated for metastatic colorectal cancer in the liver using TheraSphere®. Participation in the study involves an additional post-treatment SPECT/CT or PET/CT scan at (0-6) hours.
15791905|NCT04517630|Diagnostic Test|urinary NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomic|Determine the evolution of NGAL, TIMP-2, IGFBP7, IL-6, viral load and metabolomic at basal, and the 3 , 5 and 7 days after recruitment
15791906|NCT04517617|Other|The level of air pollution|The intervention measure is the level of air pollution, it is a non-human interventional measure based on the weighted average of various air pollutants monitored by air pollution monitoring stations during different period of pregnancy.he perinatal period.
15791907|NCT04517604|Device|Magventure MagProx100 with MagOption|iTBS will be delivered utilizing the MagVentrure MagPro X100 with MagOption stimulator that includes active and placebo coils (C-B60 Butterfly coils). Only the active setting will be used.A MagVenture C-B60 coil will be used to deliver single pulse TMS to the non-dominant MC to identify the ab-ductor pollicis brevis (APB) muscle coordinates. The integrated Localite neuronavigation system will be used.
15791908|NCT04517591|Behavioral|The Take a STAND for health|A 4-month parallel-group randomised controlled trial will be performed, in which patients post-bariatric surgery will be assessed at baseline pre-surgery (PRE-BAR), 3 months after surgery and pre-intervention (PRE-INT) and 4 months after intervention (POST). Moreover, a sub-sample of patients will perform a randomised crossover trial at baseline (PRE). Patients will complete three experimental sessions in a random manner, as follows: Prolonged sitting (SIT), in which participants engaged in prolonged sitting throughout an 5-h period and were instructed to minimize excessive movement; Exercise followed by prolonged sitting (EX), in which participants performed a 30-min moderate-to-vigorous exercise bout on a treadmill, subsequently, participants engaged in prolonged sitting as described for SIT; Light-intensity breaks (BR), in which participants completed a 3-min bout of light-intensity walking every 30 min of sitting throughout the experimental period.
15791909|NCT04517578|Other|Survey|Participants will be asked to fill in an online survey that will be anonimized.
15791910|NCT04517565|Diagnostic Test|Brain magnetic resonance imaging|Brain magnetic resonance imaging (MRI) will be done using multiple sequences to evaluate presence, type and severity of brain abnormalities in enrolled subjects.
15791911|NCT04517565|Behavioral|Neuro-psychology testing|Participants will undergo age-appropriate neuro-psychology testing to assess motor, language and other neuro-cognitive functions potentially affected by Sturge-Weber syndrome.
15791912|NCT04517552|Drug|[11C]-CS1P1|Participants will receive a single intravenous bolus injection of 6.0 - 20.0 mCi (222-740 MBq) of the investigational radiotracer [11C] CS1P1. Participants will then undergo a [11C] CS1P1 PET/CT scan.
15791913|NCT04517539|Drug|rhGM-CSF，Peginterferon alfa-b2，radiation|"Radiation:
~If there are two measurable lesions totally, One lesion received radiotherapy for 30 Gy in 5 fractions and rested for one week; If there are three measurable lesions totally, two lesion received radiotherapy for 30 Gy in 5 fractions separately.
~drug: Patients were injected subcutaneously rhGM-CSF 125mg/m2 per day from day1 to day 14, every three weeks, concurrent with radiotherapy. Peginterferon alfa-b2 90 ug in d8 in each cycle.
~And the 1 month after the end of all radiotherapy courses, 4 weeks as a course of treatment, once per course of treatment, each dose is 90μg until desease progress."
15791914|NCT04517526|Drug|pemetrexed，cisplatin/carboplatin，bevacizumab，durvalumab，SBRT|pemetrexed (500 mg/m2/d1) + cisplatin/carboplatin (20-25 mg/m2 × 3 days/AUC 5) + bevacizumab (7.5 mg/kg) + durvalumab (10 mg/kg) every 3 weeks for 4 to 6 cycles after informed consent, followed by bevacizumab and/or durvalumab anti-maintenance therapy until the emergence of what the investigator considers to be treatment-related toxicity or disease progression in the patient, followed by stereotactic radiotherapy to appropriate oligometastatic or oligoprogressive sites.
15791915|NCT04517500|Behavioral|Home-based pulmonary rehabilitation program|Subjects will wear an activity monitor while doing at home exercises using a computer tablet
15791916|NCT04517500|Behavioral|Mindful breathing module|Additional module on the computer tablet that involves inhaling and exhaling while following an animated ball on the computer screen.
15791917|NCT04517500|Behavioral|Health coaching|Weekly coaching calls to discuss rehabilitation and health process using motivational interviewing
15791918|NCT04517487|Biological|Vaginal Microbiome Transplantation (VMT)|Healthy donors vaginal fluid is introduced into recipients' vagina to replace their indigenous disease-associated microbiome
15791919|NCT04517487|Biological|Placebo|Placebo
15791920|NCT04517474|Behavioral|CANreduce|"CANreduce is an automated web-based self-help tool based on classical Cognitive Behavioral Treatment (CBT) approaches for treating cannabis dependence. It will consist of a consumption diary, eight modules designed to reduce cannabis use based on the principles of motivational interviewing, self-control practices, and methods of cognitive behavioral therapy ( strategies for goal achievement, Identifying risk situations, Dealing with cannabis craving, Dealing with relapses, Working on needs, Saying no to foster refusal skills, Dealing with burdens, Preserving achievements). Participants can study all modules at their own pace and order, though a specific order will be advised."
15791921|NCT04517474|Behavioral|psychological support|psychological support
15791922|NCT04517435|Drug|ME-401|ME-401 (60 mg) will be given by mouth every 21 days for 6 cycles on days 1-4 (dose level 1) OR days 1-7 (dose level 2) of a 21 day cycle. Dose escalation will be performed in a standard 3+3 design
15791923|NCT04517435|Drug|Rituximab|"375 mg/m2 IV/subcutaneous rituximab day 1 of 21-day cycle.
~First dose of rituximab will be given IV and subsequent doses can be either IV or SQ based on institutional guidelines."
15791924|NCT04517435|Drug|Cyclophosphamide|750 mg/m2 IV Cyclophosphamide day 1 of 21-day cycle
15791925|NCT04517435|Drug|Doxorubicin|50 mg/m2 IV Doxorubicin day 1 of 21-day cycle
15791926|NCT04517435|Drug|Vincristine|1.4 mg/m2 (max 2 mg) IV Vincristine
15791927|NCT04517435|Drug|Prednisone|100mg PO Prednisone Days 1-5 of 21-day cycle
15791928|NCT04517422|Dietary Supplement|Probiotics|Combination of Lactobacillus plantarum CECT30292, Lactobacillus plantarum CECT 7484, Lactobacillus plantarum CECT 7485, and Pediococcus acidilactici CECT 7483
15791929|NCT04517422|Other|Placebo|Combination of maltodextrin (E1400, qs) in a vegetable hydroxymethylpropyl-cellulose capsule (HPMC) of size 0
15791930|NCT04517409|Procedure|Goal-directed hemodynamic therapy|Eligible patients were equally randomized into two study groups: 1) Standard perioperative (Control group ) and 2) hemodinamic management based using radial artery pulse contour analysis (GDHT group). Randomization was performed the day before surgery by the study member responsable for anesthesia delivery using sealed opaque envelope technique stored in non-transparent containers with group allocation in a 1:1 ratio. Only patients were blinded to group allocation. Care providers and investigators could not be blinded due to the presence of the cardiac index trending monitor
15791931|NCT04517409|Procedure|Control|"Before hepatic resection (Static phase) all patiens received continuous infusion of balanced crystalloid with the goal of CVP of 5 mmHg.
~After hepatic resection (Dynamic phase), the patiens received colloid solution, vasopressors, and inotropes at the discretion of the anaesthetist, acording to CVP, MAP and orine output. In this group, CO monitoring was not performed. Intraoperative treatment goals in the control arm were flexible to avoid both extremes of clinical practice and practice misalignment."
15791932|NCT04517396|Other|Fenofibrate/fenofibric acid|The randomized intervention will be fenofibrate (Tricor) at a dose of 145 mg/d or dose-equivalent preparation of fenofibrate or fenofibric acid, for 10 days. In all cases, appropriate dose reductions will be implemented for patients with chronic kidney disease as per the approved preparation label. The intended duration of randomized treatment will be for 10 days.
15791933|NCT04517396|Other|Placebo|The control intervention will be a placebo, for 10 days.
15791934|NCT04517396|Other|Usual care|All participants will otherwise receive usual medical care
15791935|NCT04517383|Procedure|post-operative sedation|Patients with ischemic stroke will undergo endovascular thrombectomy (EVT) under general anesthesia. After the EVT surgery is done, patients in POS group will be sedated with propofol and dexmedetomidine for 6h before extubation.
15791936|NCT04517383|Procedure|routine recovery|Patients with ischemic stroke will undergo endovascular thrombectomy (EVT) under general anesthesia. Patients in Con group will be routinely recovered and extubated after the EVT surgery is done.
15791937|NCT04517370|Device|Fractional/Pixel CO2 laser|"The treatment is done with a specialized vaginal applicator which allows treatment of vagina, using the Femilift fractional micro ablative CO2 laser system (Alma Lasers, Israel), according to the usual protocol (Laser mode: Pulse, Energy: 40-80 mj/pulse).
~Before treatment, 5ml of topical anesthetic ointment (10% lidocaine in Vaseline base) will be spread in the vagina and on the vestibule for 30 minutes in both groups to avoid pain from the laser, as well as to allow the comparison between the groups (patients in both groups will not experience pain and therefore will remain blinded to their allocation)."
15791940|NCT04517344|Other|Initial Flow Rate|Patients placed on High Flow Nasal Cannula by treating physician will be randomized to initial flow rates of 1 L/kg/min, 1.5 L/kg/min, or 2 L/kg/min
15791941|NCT04517331|Procedure|Thoracic paravertebral block-single injection|The blocks were performed at the T3-T4 level bilaterally to block the dermatomes between the T2 and T6 levels (breast innervation area).
15791942|NCT04517331|Procedure|Thoracic paravertebral block-double injection|The blocks were performed at both T2-T3 and T4-T5 levels bilaterally to block the dermatomes between the T2 and T6 levels (breast innervation area).
15791943|NCT04517292|Drug|Eribulin,cisplatin|Eribulin 1.4mg/m2, IV , D1, D8；Cisplatin 75 mg/m2, IV，D1
15791944|NCT04517292|Drug|Gemcitabine,cisplatin|Gemcitabine 1250 mg/m2, IV , D1, D8； Cisplatin 75 mg/m2, IV, D1
15791945|NCT04517279|Behavioral|Invest in My Recovery Bank|The intervention has not be fully developed. It will be created in partnership with individuals serving in peer provider roles.
15791946|NCT04517279|Behavioral|Usual Care Peer Services|Usual peer services involves supporting the process of change for individuals with mental health disorder to improve their health and wellness, live a self-directed life, and strive to reach their full potential.
15791947|NCT04517266|Radiation|omit of IMI group|clincial high risk breast （≥2 risk factors）patients with 18-gene low risk an indication for regional nodal irradiation will received 2 Gy for 25 fractions to chest wall or whole breast and supraclavicular lymph nodes irradiation and sequential tumor bed boost of 2 Gy for 5 fractions following breast conserving surgery.
15791948|NCT04517266|Radiation|IMI group|clincial high risk breast （≥2 risk factors）patients with 18-gene low risk an indication for regional nodal irradiation will received 2 Gy for 25 fractions to chest wall or whole breast and supraclavicular lymph nodes irradiation and sequential tumor bed boost of 2 Gy for 5 fractions following breast conserving surgery.
15791949|NCT04517253|Drug|Baricitinib|Administered orally
15791950|NCT04517240|Other|endoscopy|upper and lower endoscopy and fecal calprotectin test
15791951|NCT04517227|Drug|Durvalumab|Durvalumab is a human monoclonal antibody (mAb) of the immunoglobulin G (IgG) 1 kappa subclass that inhibits binding of PD-L1 and is being developed by AstraZeneca/MedImmune for use in the treatment of cancer.
15791952|NCT04517227|Procedure|Transcatheter Hepatic Arterial Chemoembolization (TACE)|TACE techniques have been described in the NCCN and ESMO-ESDO guidelines, including cTACE and DEB-TACE.
15791953|NCT04517227|Procedure|Ablation|In this study, thermal ablation could be conducted with radiofrequency (RFA) or microwave (MWA).
15791954|NCT04517214|Drug|Toripalimab|PD-1 inhibitor
15791955|NCT04517214|Radiation|IMRT to the nasopharynx and neck|IMRT to the nasopharynx and neck
15791956|NCT04517214|Drug|Gemcitabine and Cisplatin Chemotherapy|Systemic chemotherapy
15791957|NCT04517214|Drug|Adjuvant chemotherapy with Capecitabine|Adjuvant chemotherapy after radiation
15791958|NCT04517201|Drug|iNCDSS based insulin regime|Patients of this group will receive the insulin regime set by the AI assisted insulin titration system (iNCDSS).
15791959|NCT04517201|Drug|Physician based insulin regime|Patients of this group will receive the insulin regime recommended by professional endocrinologists.
15791960|NCT04517188|Drug|Povidone-Iodine Solution 1.25% w/w [0.125% available iodine] USP|Single topical administration
15792615|NCT04511780|Other|questionnaire filling|assessment of post-traumatic stress, anxiety and burn out
15791961|NCT04517175|Diagnostic Test|Flow cytometry|Flow cytometric immunophenotyping and determination of proliferative activity by means of Ki-67.
15791962|NCT04517162|Drug|Collagen-Polyvinylpyrrolidone|1.5 mL of polymerized-type I collagen or placebo, every 12 h for 3 days and then every 24 h for 4 days (in total 10 injections in 7 days)
15791963|NCT04517149|Biological|4D-125 IVT Injection|4D-125 drug product developed for gene therapy, which comprises an AAV capsid variant (4D-R100) carrying a codon-optimized human Retinitis Pigmentosa GTPase Regulator transgene.
15791964|NCT04517149|Other|Observational|Natural History
15791965|NCT04517136|Behavioral|Assessment of work-related stress|Assessment of burnout, mindfulness, interoceptive awareness, anxiety, post-traumatic stress disorder, coping flexibility and sleep through questionnaires.
15791966|NCT04517136|Biological|Saliva sample collection|Saliva sample is collected before and after emotional stimulation in order to measure resting-state allostatic load biomarkers: Dehydroepiandrosterone (DHEA), cortisol and chromogranin A levels
15791967|NCT04517136|Device|Cardiac and electrodermal recordings|Electrocardiogram and electrodermal activity (tonic and phasic) is collected at rest and after emotional stimulation.
15791968|NCT04517136|Behavioral|Assessment of behavioral response to emotional stimulation|"Emotional stimulation involves asking the participants to remember a recent event related to the COVID-19 crisis that has been emotionally difficult for them.
~Perceived stress, situational awareness and emotions is assessed after emotional stimulation through questionnaires."
15791969|NCT04517123|Other|Prone Positioning|Prone Positioning
15791970|NCT04517110|Drug|Pregabalin 300 mg|Pregabalin 300 mg, capsule
15791971|NCT04517110|Drug|Pregabalin 75 mg|Pregabalin 75 mg twice daily, capsules
15791972|NCT04517110|Drug|Pregabalin 300 mg Placebo|Placebo, matching Pregabalin 300 mg capsule
15791973|NCT04517110|Drug|Pregabalin 75 mg Placebo|Placebo, matching Pregabalin 75 mg capsules
15791974|NCT04517110|Other|Usual Care|Usual Care
15791975|NCT04517097|Biological|blood sample|one blood sample and one questionnaire to each patient and salaried staff included
15791976|NCT04517058|Device|transcranial direct current stimulation|combining tDCS and SSRIs
15791977|NCT04517045|Drug|Dachengqi decoction|Raw rhubarb 30g, Glauber's salt 30g, Citrus aurantium 20g, Magnolia officinalis 20g. The decoction was decocted uniformly in the decoction room of Xinhua Hospital, Shanghai Jiaotong University School of Medicine, and decocted 200 mL thickly, fed via nasogastric tube/nasal intestine tube and enema, 1 dose/d, and continued treatment until the end of the trial
15791978|NCT04517045|Drug|probiotic L9|L92 2 tablets/time, tid, oral or nasal feeding
15791979|NCT04517045|Other|Conventional treatment|Conventional treatment
15791980|NCT04517019|Device|"Fitness tracker based activity training for Arm A and B. Booklet physical training, exercise and cancer and an introduction about physical activity during cancer therapy for Arm A, B, C"|"Patients receive a fitness tracker, a booklet Physical training, exercise and cancer and an in-person briefing about physical activity during cancer therapy. With offered guidelines for the daily step counts patients should improve their physical activity during radiotherapy of breast cancer. A weekly feedback and a new goal for the next week will be provided until the individual patient reaches a daily activity of 6000 steps. The setting will be to maintain to this daily activity of 6000 steps during radiotherapy."
15791981|NCT04517006|Behavioral|Self-focused acts|Completion of daily acts for personal enjoyment.
15791982|NCT04517006|Behavioral|Prosocial acts|Completion of daily acts for the benefit of others.
15791985|NCT04516980|Other|Questionnaires administration|"Administration of Identification of Functional Ankle Instability (IdFAI) and the following assessment scales: Self-reported question assess the ankle instability as functional/stable or not functional/unstable, Foot and Ankle ability Measure Italian Version - Activity Daily Living (FAAM-I/ADL), Short-form 36-item Health Survey Italian Version (SF-36), Numeric Rate Scale pain (NRS Pain), Visual Analogic Scale Ankle Instability (VAS ankle instability).
~After a week the participants will fill in the following questionnaires: Identification of Functional Ankle Instability (IdFAI), Numeric Rate Scale pain (NRS Pain), Visual Analogic Scale Ankle Instability (Vas ankle instability) with the additional question to measure the change in complaints."
15791988|NCT04516954|Biological|Convalescent COVID 19 Plasma|A total of 500 ml of convalescent COVID 19 plasma will be transfused intravenously per subject
15791989|NCT04516941|Drug|Edoxaban Tablets|Treatment
15791990|NCT04516941|Drug|Colchicine Tablets|Treatment
15791991|NCT04516928|Diagnostic Test|Anti-SARS-CoV2 Serology|The anti-SARS-CoV2 serological status will be measured on a blood sample collected at Day 0.
15791992|NCT04516928|Other|Questionnaire|A questionnaire on socio-demographical status, health status and lifestyle habits during the pandemic will be filled by the participants at Day 0.
15791993|NCT04516915|Drug|IMU-838|IMU-838 twice daily at 22.5mg doses for 14 days
15791994|NCT04516915|Drug|Oseltamivir|Oseltamivir twice daily at 75mg doses for 14 days
15791995|NCT04516902|Drug|Lysergic Acid Diethylamide|A moderate dose of 100 μg LSD will be administered.
15791996|NCT04516902|Drug|3,4-methylenedioxymethamphetamine|A moderate dose of 100 mg MDMA will be administered.
15791997|NCT04516902|Other|LSD Placebo|Pure alcohol instead of an alcoholic solution containing LSD
15791998|NCT04516902|Other|MDMA Placebo|Mannitol capsules instead of capsules containing MDMA
15791999|NCT04516889|Procedure|Doubled sutured SFIOL|Recruited subjects would undergo implantation of SFIOL with the modified technique under either local or general anesthesia. The surgeon would mark the sclerotomies as per routine sutured SFIOL at 2mm behind the nasal and temporal limbus, followed by passage of 2 pairs of prolene sutures. The intraocular lens with islets would be implanted into the posterior chamber and sutured to the sclera as per single suture SFIOL.
15792033|NCT04516538|Diagnostic Test|6 Minutes Walk Test|a standardized test of an individual's functional ability that involves walking the greatest distance a person can walk in six minutes. This walking may be limited by shortness of breath or fatigability.
15792616|NCT04511767|Other|Do not take any interventions|Do not take any interventions
15792000|NCT04516876|Other|Camp-based bimanual intensive training(BIT)|The day-camp BIT model will be delivered in a group-based design. In day-camp model, each child is assigned to a trained therapist to maintain at least a 1:1 to 1:2 ratios of therapy and child. The therapist will monitor and modify the activities to fit each individual's ability and need to make sure the intervention quality is equivalence to the individualized treatment method. The chosen tasks of each intervention session have to be considering the child's preference, age-appropriated, and at the right level of difficulty. Target movements are embedded in the functional activities, whereby the environment is manipulated to vary task requirement and the difficulty is graded to match the child's capacity.
15792001|NCT04516863|Diagnostic Test|German Autobiographical Memory Interview short-form|Diagnostic Test
15792002|NCT04516850|Genetic|Expression of receptors and activating proteases|Level of expression of the mRNA of the genes encoding ACE2, TMPRSS2, TMPRSS4 and AR along with reference genes (beta-actin and EPCAM) in nasopharyngeal swabs taken from patients tested for COVID-19
15792003|NCT04516850|Genetic|Polymorphism of the HSD3B1|Formalin-fixed paraffin embedded tissue blocks will be amplified using polymerase chain reaction (PCR) based experiments followed by direct sequencing (Sanger sequencing)
15792004|NCT04516837|Drug|Eltrombopag|Eltrombopag 25-75 mg oral daily according to platelet response.
15792005|NCT04516837|Drug|rhTPO|Rh-TPO 300U/kg subcutaneous injection once daily for 7 consecutive days, followed by a tapering dose in maintenance therapy.
15792006|NCT04516824|Procedure|Orthopaedic Surgical Procedures|Intramedullary nails, Dynamic Compression Plate, Dynamic Hip Screw, Manipulation Under Anaesthesia POP, Ilizarov, Cannulated Screw Fixators, Bipolar Hemiarthroplasty, Locking Compression Plate, AO External fixators, Tension Band Wiring Patella, Pelvis and Acetabulum Fixations, Elbow Reconstructions, K wiring, Disc Excision, Spine Fracture i-e TPSF, Posterior Cervical Decompression and LMS, Dura repair, AD cage,Bilateral Total Hip Replacement, Unilateral Total Hip Replacement, Bilateral Total Knee Replacement, Unilateral Total Knee Replacement, Knee Arthroscopy for Mensicectomy, Arthroscopic Anterior Cruciate Ligament reconstruction,Removal of Implant, Amputations, VAC dressings,Wound wash, Arthrotomy for Septic Arthritis, Biopsy
15792007|NCT04516811|Biological|COVID-19 convalescent plasma (CCP) plus standard of care (SOC)|A single unit of approximately 200-250 mL of CCP that contains anti-SARS-CoV-2 collected by plasmapheresis from a volunteer who recovered from COVID19 with SOC as determined by local practice and guidelines.
15792008|NCT04516811|Biological|Standard of care (SOC) plus placebo|A single unit of 200 mL normal saline with SOC as determined by local practice and guidelines
15792009|NCT04516798|Other|vibration|local and whole-body vibration were applied
15792010|NCT04516785|Diagnostic Test|FIT and VOC|Stool sample (FIT) analysed for blood in faeces and urine sample (VOC) analysed for the presence of volatile organic compounds
15792011|NCT04516772|Device|Visian TICL|The Visian TICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
15792012|NCT04516759|Drug|AZD1656|50mg film-coated tablets (at daily dose of 100mg BID)
15792013|NCT04516759|Other|Placebo|Matched placebo tablets
15792014|NCT04516746|Biological|AZD1222|AZD12222 is a recombinant replication-defective chimpanzee adenovirus expressing the SARS-CoV-2-5 surface glycoprotein.
15792015|NCT04516746|Biological|Placebo|Commercially available 0.9% (n/V) saline for injection.
15792016|NCT04516733|Other|supportive care|visit with supportiv unit and neuropsychologue every 3 months
15792017|NCT04516720|Other|data collection|Diagnostic data : date and description of first symptoms,date of radiological diagnosis, tumor localization, number of lesions, date of histological diagnosis, histological diagnostic mode, histological diagnosis, WHO grade (I, II, III or IV), immunohistochemic data, molecular alterations therapeutic sequence : type of treatment, baseline exam before each treatment, surgery, radiothérapy, systemic treatment, clinical study, follow up until death
15792018|NCT04516707|Other|clinical database|"The various clinicam database will be collected solely to meet the objectives of the study.
~All data collected to create the database for this project will be anonymized"
15792019|NCT04516694|Behavioral|Financial incentive (gain)|Participants will receive a daily financial incentive framed as a gain with money allocated each day of adherence to a self-care coal. Participants will receive an additional weekly incentive for meeting a clinical outcome goal.
15792020|NCT04516694|Behavioral|Financial incentive (loss)|Participants will receive a daily financial incentive framed as a loss with money allocated up front and taken away each day of non-adherence to a self-care coal. An additional weekly incentive will be deducted for failure to meet a clinical outcome goal.
15792021|NCT04516681|Drug|Ascorbic acid|1.5g/kg/day, D1-3, every 2 weeks
15792022|NCT04516681|Drug|FOLFOXIRI Protocol|CPT-11 165 mg/m² d1 concurrent with Leucovorin 400 mg/m², followed by Oxaliplatin 85 mg/m² d1 followed by Bolus 5FU 400 mg/m² , followed by Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks with or without bevacizumab 5mg/kg, every 2 weeks
15792023|NCT04516655|Drug|chidamide combined with rituximab and high-dose methotrexate|chidamide 20 mg biw PO day1-14 and rituximab 375 mg/m2 IV given on day 1 and methotrexate 3.5g/m2 IV given on day 2 of every 21-day cycle for 6 cycles in untreated patients with primary central nervous system lymphoma
15792024|NCT04516629|Diagnostic Test|heart rate variability, pulse diagnosis device|check heart rate and pulse rate
15792025|NCT04516616|Drug|Cisplatin+Albumin-bound paclitaxel (1 cycle) and PD-1 monoclonal antibody+Cisplatin+Albumin-bound paclitaxel (2 cycles)|PD-1 monoclonal antibody （SHR-1210)：200mg，IV infusion，Q3W Cisplatin：75-80 mg/m2, IV infusion, Q3W Albumin-bound paclitaxel: 260 mg/m2，30min，IV infusion, Q3W
15792026|NCT04516603|Drug|Fampridine SR|Fampridine is an inhibitor of voltage-gated potassium (Kv) channels and is approved in Switzerland for treatment of gait problems in patients with Multiple Sclerosis (MS).
15792027|NCT04516603|Drug|Placebo|no active component
15792028|NCT04516577|Other|Assesssing the severity of pulmonary alveolar proteinosis|Three severity scores will be used to assess the severity of patients with pulmonary alveolar proteinosis.
15792031|NCT04516551|Biological|anti-CD19 allo-CAR-T cells|The T cells collected from haploidentical donors have been manufactured to express CAR to binding CD19 on B-cell leukemia.
15792034|NCT04516538|Diagnostic Test|Timed up and go|A simple test used to assess a person's mobility and requires both static and dynamic balance. It uses the time it takes for a person to get up from a chair, walk three metres, turn around, walk to the chair and sit down.
15792035|NCT04516538|Diagnostic Test|Isokinetic Body weight-based quadriceps intermittent fatigue test (BW-QIF Test)|"The BW-QIF test is an interval incremental contraction test including blocks of discontinuous 100-s effort. Neuromuscular evaluation of the knee extensors between blocks (duration 25 s) includes one maximal voluntary contraction, one contraction at the 60% of the actual maximal force and at the 80% of the actual maximal force. During each contraction, transcranial magnetic stimulation over the motor cortex will be delivered to assess corticospinal voluntary activation (central fatigue). Single-twitch electrical stimulations will be delivered on the femoral nerve during the maximal voluntary contraction and at rest to evaluate peripheral fatigue.
~The isokinetic BW-QIF test blocks consist in 100 contractions at 120° deg.s-1 and 60° of range of motion (0.5-s contraction /0.5-s rest)."
15792036|NCT04516538|Diagnostic Test|Cycloergometer body weight-based quadriceps intermittent fatigue test (BW-QIF Test)|"The BW-QIF test is an interval incremental contraction test including blocks of discontinuous 100-s effort. Neuromuscular evaluation of the knee extensors between blocks (duration 25 s) includes one maximal voluntary contraction, one contraction at the 60% of the actual maximal force and at the 80% of the actual maximal force. During each contraction, transcranial magnetic stimulation over the motor cortex will be delivered to assess corticospinal voluntary activation (central fatigue). Single-twitch electrical stimulations will be delivered on the femoral nerve during the maximal voluntary contraction and at rest to evaluate peripheral fatigue.
~The BW-QIF test blocks on the cycloergometer consist in 100 s of cycling at 60 Revolution Per Minute (RPM)."
15792037|NCT04516538|Diagnostic Test|Isometric BW-QIF Test (Body weight-based quadriceps intermittent fatigue test)|"The BW-QIF test is an interval incremental contraction test including blocks of discontinuous 100-s effort. Neuromuscular evaluation of the knee extensors between blocks (duration 25 s) includes one maximal voluntary contraction, one contraction at the 60% of the actual maximal force and at the 80% of the actual maximal force. During each contraction, transcranial magnetic stimulation over the motor cortex will be delivered to assess corticospinal voluntary activation (central fatigue). Single-twitch electrical stimulations will be delivered on the femoral nerve during the maximal voluntary contraction and at rest to evaluate peripheral fatigue.
~The isometric BW-QIF test blocks consist in 10 contractions (5-s contraction / 5-s rest)."
15792038|NCT04516525|Device|cardiac resynchronisation therapy (CRT) implantation|In a group of 100 patients with chronic cardio-renal syndrome, the blood and urine biomarkers are tested before CRT implantation and after 48 hours, 3 months and 1 year of follow-up.
15792039|NCT04516512|Biological|Blood draw|For each participants to the research a peripherical blood draw will be performed
15792040|NCT04516486|Other|retrospective metagenomics on clinical samples collected during hospitalization|Massive sequencing of respiratory samples (restrospective)
15792041|NCT04516473|Procedure|Abdominal Body Contouring|These are surgeries that correct for excess skin and its adverse consequences. The surgeries that focus on central area to remove a large hanging pannus is usually called panniculectomies or abdominoplasties; the former is focused on the excision of excess tissue to relieve impairment while the latter is generally considered a cosmetic surgery. The form of the surgery is case dependent and can range from removing apron of skin to complete contouring of the abdomen with tightening of the abdominal muscle and moving the belly button.
15792042|NCT04516460|Device|Interventional arm: endoscopic resection plus PuraStat®|Interventional arm: PuraStat® applied through a catheter delivery system via the endoscope is used to prevent bleeding after endoscopic resection of colorectal neoplastic lesions
15792043|NCT04516447|Drug|ZN-c3|Investigational drug
15792044|NCT04516447|Drug|Carboplatin|Carboplatin is an approved drug
15792045|NCT04516447|Drug|Pegylated liposomal doxorubicin|Pegylated liposomal doxorubicin (PLD) is an approved drug
15792046|NCT04516447|Drug|Paclitaxel|Paclitaxel is an approved drug
15792047|NCT04516447|Drug|Gemcitabine|Gemcitabine is an approved drug
15792048|NCT04516434|Device|Neurometer Neurotron CPT|All participants will undergo CPT testing. A Neurotron catheter (12-French) with electrode will be inserted through the urethra into the bladder. The catheter balloon will be inflated and positioned at the urethrovesical junction to stimulate the urethra 10-14 mm from the bladder neck. For bladder stimulation, the catheter balloon will be deflated and the catheter will be advanced into the bladder. The device will deliver sine wave stimulus pulses at 5, 250, and 2,000 Hz. CPT will be established using an automated forced choice paradigm by the method of levels. Testing order of the bladder and urethra will be randomized between participants.
15792049|NCT04516434|Procedure|Cystometry|After bladder stimulation or during intraurethral stimulation, cystometry will be performed to assess bladder sensation and storage. A dual-chamber 8-French catheter will be passed through the urethra into the bladder for retrograde filling. A second 8-French catheter will be placed in the vagina to measure intra-abdominal pressure. A stimulation electrode catheter will only be inserted in the intraurethral stimulation arm. EMG pads will then be placed at 3 and 9 o'clock on each side of the perineum. The bladder will then be filled with room-temperature sterile saline solution in a retrograde fashion using a pump. Bladder sensation and urgency will be assessed while filling.
15792050|NCT04516434|Procedure|Pressure-flow study|A pressure flow study will be performed to evaluate voiding function after stimulation. The transurethral and intra-vaginal catheters are left in place after cystometry and the participant will be asked to void around them, into a commode. Bladder and abdominal pressures will be recorded, as well as urine flow over time.
15792051|NCT04516421|Dietary Supplement|Protein supplementation|The experimental group contained 14g protein, 0.6g fat, 7g carbohydrate, 4.4 g BCAA , 2.4g glutamate, 0.5g arginine and 0.4g taurine with 90 kcal/pack (Affix Health, Taiwan Branch).
15792052|NCT04516421|Dietary Supplement|Placebo oat drink|placebo oat drink contained 1.5g protein, 0.5g fat, 0.1g carbohydrate with 8.3kcal/pack (Zhan Xuan, Co. Ltd., Taiwan).
15792053|NCT04516408|Biological|Recombinant zoster vaccine|Recombinant zoster vaccine (RZV) is indicated for prevention of herpes zoster in adults aged ≥ 50 years old. RZV contains a varicella zoster virus glycoprotein E antigen and the AS01B adjuvant system.
15792054|NCT04516408|Biological|Placebo|Sterilized water
15792055|NCT04516395|Other|Combined antibiotic regimens|Combined antibiotic combinations defined as the optimal antibiotic combination regimens which are created from in vitro study and the application of PK/PD.
15792056|NCT04516395|Other|Standard antibiotic regimens|Standard antibiotic regimens defined as the antibiotic regimens which are generally given to the patients following to the hospital protocol.
15792057|NCT04516382|Drug|PTG-300|Active drug
15792058|NCT04516369|Genetic|voretigene neparvovec|Voretigene neparvovec is an adeno-associated viral type 2 (AAV2) gene therapy vector driving expression of normal human retinal pigment epithelium 65 kDa protein (hRPE65) gene.
15792059|NCT04516356|Other|Korean hand acupressure|According to the working principle of Korean hand acupressure; There are active points and areas in the hands and feet that fit the whole body. The active points on the hands and feet are properly matched to reflect the anatomy of the whole organism. Areas in the body and systems suitable for them are in constant contact. In the patient, the signal wave moves from the damaged point or area and reaches the appropriate point immediately. Thus, changes such as severe pain, skin discoloration, hardening, thickening and thinning in some parts of the skin occur at that point. With the stimulation of the effective point, a treatment wave occurs that heals the sick organ.
15792060|NCT04516343|Device|Robotic Ankle Assist Device (RAAD)|The RAAD (Robotic Ankle Assist Device) is an intelligent, powered ankle device designed to increase independence, mobility, and deliver gait training to children with movement disorders, such as CP
15792061|NCT04516330|Genetic|miRNA|miRNA's expressed in breast cancer
15792062|NCT04516317|Other|None (Observational study Group intravenous artesunate)|Retrospective descriptive study of Group intravenous artesunate
15792063|NCT04516317|Other|None (Observational study Group intravenous quinine)|Retrospective descriptive study of Group intravenous quinine
15792064|NCT04516304|Dietary Supplement|Placebo|4 tablets/d (2 in the morning and 2 in the evening)
15792065|NCT04516304|Dietary Supplement|S-equol|4 tablets/d (2 in the morning and 2 in the evening), providing 10 mg S-equol total a day Other Names: •Equelle®
15792066|NCT04516291|Drug|Vupanorsen|Vupanorsen and placebo will be provided as prefilled syringes packaged and dispensed in cartons with tamper-evident seals. Only single-use syringes will be used.
15792067|NCT04516291|Drug|Placebo|Vupanorsen and placebo will be provided as prefilled syringes packaged and dispensed in cartons with tamper-evident seals. Only single-use syringes will be used.
15792068|NCT04516278|Biological|bevacizumab|1.25 mg, intravitreal injection
15792069|NCT04516265|Procedure|neurodevelopmental treatment|A personally designed treatment program will be applied in line with the principles of neurodevelopmental treatment.
15792070|NCT04516265|Procedure|video-based trunk training|Games developed for the use of children with cerebral palsy will be used for trunk training.
15792071|NCT04516265|Procedure|Video-based trunk training will apply with Theratogs|Video-based trunk training will apply with Theratogs
15792072|NCT04516252|Behavioral|BodyWorks Intervention|BodyWorks (BW), a Comprehensive Behavioral Family Lifestyle Interventions (CBFLI), a national, empirically validated, curriculum-based 7-week program will be implemented (Borden et al., 2012; DHHS, 2013)
15792073|NCT04516252|Behavioral|Canine Curriculum|Using our team's expertise in veterinary medicine, human-animal interaction, and animal behavior modification, develop an empirically-based, 7-week module on canine health and behavior.
15792074|NCT04516252|Behavioral|Ecological Momentary Assessment|Ecological Momentary Assessments (EMA) of physical activity will be conducted using mobile phones for 7 weeks of the BW program, prospectively collecting data on 4 days per week (Saturday to Tuesday) (Dunton et al., 2011; Liao et al., 2016).
15792075|NCT04516252|Behavioral|Physical Activity Trackers|Three types of consumer-grade wireless personal activity trackers (PATs): FitBit Ace® designed for children 8 years of age and older; FitBit Flex 2® for adults (Diaz et al., 2015; Espinoza et al., 2017); and FitBark®, wireless, global positioning systems (GPS)-based personal activity trackers for dogs (Patel et al., 2017). This approach will allow us to evaluate quantity (number of steps) and intensity of physical activity in the adolescents, their parents, and their dogs, as well as to synchronize Fitbit Ace and FitBark to establish the amount of shared physical activity of adolescents and their dogs.
15792076|NCT04516239|Device|THA|Three surgeons performed the surgeries through a posterior surgical approach in both groups. The fascia lata was opened and the gluteus maximus was split in line with its muscle fibers. The short external rotators were released from the greater trochanter. A posterior capsulotomy was performed and the hip dislocated. For the THA, the standard techniques proposed by the manufacturer for insertion of the stem were followed. Neck sleeve adapters and three different prosthetic neck-shaft angles (125, 135, and 145) were available to adjust leg length and femoral offset with the large-diameter head THA system.
15792077|NCT04516239|Device|HR|Three surgeons performed the surgeries through a posterior surgical approach in both groups. The fascia lata was opened and the gluteus maximus was split in line with its muscle fibers. The short external rotators were released from the greater trochanter. A posterior capsulotomy was performed and the hip dislocated. In the HR group, the capsulotomy was completed circumferentially, and the gluteus tendinous insertion on the femur was released in all men, but only when needed in women, to improve femur mobilization.
15792078|NCT04516226|Other|Vaginal cleansing with chlorhexidine gluconate solution|Cleansing of the vaginal walls with chlorhexidine gluconate solution for women diagnosed with PPROM
15792079|NCT04516213|Other|Enteral Formula With (PHGG)|Pediatric subjects will be fed a Peptide-based Enteral Formula With Partially Hydrolyzed Guar Gum (PHGG)
15792080|NCT04516200|Device|transcranial direct current stimulation and traditional physical therapy program|Transcranial stimulation will be applied only for the study group.
15792081|NCT04516200|Other|designed physical therapy program|sensory training and balance training
15792082|NCT04516187|Diagnostic Test|signs and symptoms, blood tests|signs and symptoms as observed by the treating GP, blood tests (CRP, Procalcitonin, White blood cell count)
15792083|NCT04516174|Procedure|Transversus abdominis plane block using ropivacaine|Before anesthesia, the ultrasound-guided bilateral transversus abdominis plane block using 0.25% ropivacaine was perdormed by anesthesiologist who is not involved in intraoperative management and postoperative follow-up and evaluate the effect after the block completed.
15792084|NCT04516174|Drug|Dexmedetomidine|After finished the transversus abdominis plane block, then perform tracheal intubation and start the infusion of dexmedetomidine.
15792143|NCT04515693|Other|6 Minutes Walking Test|A walkway of 12 meters will be marked with one cone at each end. The patient will be instructed to walk back and forth as many times as possible in six minutes.
15792085|NCT04516174|Procedure|Transversus abdominis plane block using saline|Before anesthesia, the ultrasound-guided bilateral transversus abdominis plane block using saline was perdormed by anesthesiologist who is not involved in intraoperative management and postoperative follow-up and evaluate the effect after the block completed.
15792086|NCT04516174|Drug|Saline|After finished the transversus abdominis plane block, then perform tracheal intubation and start the infusion of saline, dosage and infusion method of saline are consistent with dexmedetomidine.
15792087|NCT04516161|Drug|Radium-223 dichloride (Xofigo, BAY88-8223)|Receiving Ra-223 either alone or in combination with other cancer therapies at any time after diagnosis of mCRPC
15792088|NCT04516148|Drug|Cefazolin|Dosing per hospital policy
15792089|NCT04516148|Drug|Clindamycin|Dosing per hospital policy
15792090|NCT04516135|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo 3D CRT
15792091|NCT04516135|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
15792092|NCT04516135|Other|Quality-of-Life Assessment|Ancillary studies
15792093|NCT04516135|Other|Questionnaire Administration|Ancillary studies
15792094|NCT04516135|Radiation|Volume Modulated Arc Therapy|Undergo VMAT
15792095|NCT04516122|Procedure|Biospecimen Collection|Undergo collection of blood samples
15792096|NCT04516122|Procedure|Dual X-ray Absorptiometry|Undergo DXA scan
15792097|NCT04516109|Device|Modified hip capsule side fixed slotted cannula|Modified hip capsule side fixed slotted cannula used during surgery to allow for continued access to the hip joint.
15792098|NCT04516109|Device|Modified bone graft delivery tool set|Modified bone graft delivery tool set for grafting subchrondral cysts arthroscopically during hip arthroscopy procedure.
15792099|NCT04516096|Drug|AMX0035|Tauroursodeoxycholic Acid and Sodium Phenylbutyrate orally given twice a day
15792100|NCT04516083|Diagnostic Test|Mismatch repair instability somatic and germline testing|Each Endometrial Endometrioid adenocarcinoma is routinely stained for MMR mutation to seek for tumor genetic instability. If stains positive, the patient is called in for genetic blood testing to look for the same mutation in the germline.
15792101|NCT04516070|Other|Questionnaire Administration|Ancillary studies
15792102|NCT04516070|Radiation|Stereotactic Radiosurgery|Undergo SRS
15792103|NCT04516057|Drug|Nabilone|After the screening period, participants randomized to the nabilone arm will receive nabilone for 8 weeks. Participants will then be followed for 8 weeks following completion of the study treatment.
15792104|NCT04516057|Other|Placebo|After the screening period, participants randomized to the placebo arm will receive placebo capsules for 8 weeks. Participants will then be followed for 8 weeks following completion of the study treatment.
15792105|NCT04516044|Behavioral|Video games|See arm description
15792106|NCT04516031|Procedure|Posterior Component Separation with Transversus Abdominis Muscle Release|The posterior component separation technique with transversus abdominis muscle release was done as prescribed in Novitsky et al in 2012.
15792107|NCT04516031|Procedure|Mesh-only repair|The prosthetic mesh only repair was done as described by Wantz in 1991.
15792108|NCT04516018|Other|Cold exposure|Subjects will be exposed to shivering thermogenesis for at least 1 hour for 10 days
15792109|NCT04516005|Procedure|foot reflexology|Acupressure was applied at the plantar side of the right foot at the first metatarsal bone, around 1-1.5 centimeters proximal to the first metatarsophalangeal joint. (Figure 2) Approximately 3-kilogram pressure was applied by using a knuckle of the right index finger (dorsal part of the proximal interphalangeal joint in flexing position) in a perpendicular manner and held for 15 seconds (sec) then released for 5 sec. This hold-release cycle was done 5 times over the course of 2 min. This method was recommended by the Department of Thai Traditional and Alternative Medicine in accordance with the Zone theory and the Meridian theory.
15792110|NCT04515992|Behavioral|High Intensity Body-weight Circuit Training (HIBC)|HIBC Exercise Protocol- The HIBC circuit repetition and order is as follows: modified squats (10 repetitions), modified rows (5 repetitions), crunches (10 repetitions), and modified push-ups (5 repetitions). The exercise sessions involved repeating a series of repetitions of each movement in sequence, and completing as many sequences as possible in good form in the time allotted for the exercise (initially, 5 minutes). Participants were instructed to complete three sessions per week and documented the number of cycles completed. After 3 weeks of consistent training, participants were asked to add a 4th session each week as tolerated. Initially, the HIBC sessions were 5 minutes long, and the duration of the sessions were increased by one minute each week as tolerated beginning in week four, peaking at 10-minutes per session as early as the eighth week of training. Session duration was capped at 10 minutes.
15792111|NCT04515979|Drug|Vactosertib 300 mg BID and pembrolizumab 200 mg IV|Vactosertib 300 mg orally (PO) BID(5 days on/2days off) and pembrolizumab 200 mg IV (Q3W).
15792112|NCT04515966|Drug|Methylprednisolone Injection [Solu-Medrol]|A total 1 ml of injectate consisting of 0.5 ml of depo-Medrol (methylprednisolone acetate 40mg/ml) and 0.5 mL of 1% lidocaine will be injected into the carpal tunnel under ultrasound guidance to deliver it into the target area. After completion of the injection, the distal carpal tunnel is scanned to ensure injectate distribution within the distal aspect of the carpal tunnel.
15792113|NCT04515966|Device|wrist splint|A standard wrist splint
15792114|NCT04515953|Drug|ND-340|ND-340: Subjects will receive a single administration of ND-340 at the specified dose in each arm after TKA.
15792115|NCT04515953|Drug|IV-PCA|IV-PCA: Intravenous patient-controlled analgesia (IV-PCA), morphine, will be administered in subjects of control group after TKA for postoperative pain management as standard practice.
15792116|NCT04515940|Dietary Supplement|acceptability, tolerance and palatability study|prospective acceptability study
15792117|NCT04515927|Drug|JS002|Biological: JS002 Administered by subcutaneous injection
15792118|NCT04515901|Drug|2% lidocaine|Viscous lidocaine
15792119|NCT04515901|Other|Placebo|Methylcellulose and cherry flavouring
15792120|NCT04515888|Other|PFDI-20 / PFIQ-7 questionnaires|PFDI-20 / PFIQ-7 questionnaires (one shot)
15792144|NCT04515667|Behavioral|Mindfulness|Participants will view a brief mindfulness video
15792145|NCT04515667|Behavioral|Video|Participants will view a control video
15792146|NCT04515654|Other|IDEAS (Identity Evolution and Sharing) Performance|60 minute webinar depicting first-hand stories of transgender and gender non-conforming individuals followed by expert panel/talk-back
15792147|NCT04515641|Drug|Islatravir|Two ISL 30 mg capsules taken by mouth.
15792121|NCT04515875|Behavioral|Daily Engagement Meaningful Activity (DEMA)|This group will receive 7 individualized sessions, 1 face-to-face session at week 1 and via 6 bi weekly telephone sessions delivered by a trained intervener. DEMA will use the principles of problem-solving therapy and consistent with the overall goals of this intervention; and will provide autonomy support, classify needs and goals, generalize manageable solutions, engage in self-selected activities under family support, and self-evaluate failure and success or renew problem-solving as needed. Each session consists: 1) MCI dyads are guided to use the principles of problem-solving therapy to review their personalized, self-selected meaningful activities and plan next steps to continue the activity, identify and establish a plan for additional activities; and 2) the intervener and dyad discuss one of the 6 topics in the Toolkit such as introducing of the intervention and meaningful activity concepts, understanding MCI, its treatments, management, resources, and planning for the future.
15792122|NCT04515875|Behavioral|Information Support (IS)|This group will attend 1 face-to-face meetings to receive an overview of what will happen in the study and an initial Alzheimer disease educational brochure from the Alzheimer's Association (AA). The face-to-face sessions will take place at the IADC Clinical Core clinic, Indiana University Center of Excellence of Women's Health clinic, or Indiana School of Nursing conference room that based on patient-caregiver dyad's preference. Then they will receive 6 bi weekly follow-up phone calls and have the opportunity to ask only questions related to the educational materials. After completing Time 4 data collection, the patient-caregiver dyads will receive DEMA Self-Management Tool kit package through mail.
15792123|NCT04515862|Other|Breastfeeding education|The importance of breastfeeding Benefits of breastfeeding for mother and baby Structure of the breast and milk production Breastfeeding techniques and positions Breastfeeding problems and breast care
15792129|NCT04515836|Drug|Olaparib|Olaparib is a chemotherapy drug (packaged as a pill) that can be taken by mouth, twice daily.
15792130|NCT04515810|Behavioral|PACT|PACT (Planning Advance Care Together) is the mobile app interactive prototype that has been developed by the PI (Shen) in partnership with developers. PACT represents a digitally enhanced mHealth app that will help patients engage in ACP as a social process and ultimately plan for, document, and receive their preferred end-of-life care. PACT will be a digital solution that accounts for the social nature of ACP. PACT will be a progressive web application (PWA) that will allow for a virtual engagement in ACP with patients' loved ones and advance directive documentation process.
15792131|NCT04515797|Drug|Glecaprevir and Pibrentasvir|4 weeks of treatment starting within 24 hrs of kidney transplant
15792132|NCT04515784|Behavioral|Safety Aid Reduction Treatment for PTSD|START-PTSD includes many of the key elements found in empirically supported treatments for PTSD including: a) psychoeducation regarding the development and maintenance of PTSD; and b) exposure to internal sensations and external situations that are connected to one's fear/distress response via identification and elimination of safety aids. Known safety aids to be covered include: cognitive avoidance (e.g., using mental distractions to avoid trauma-related images); situational avoidance (e.g., avoiding crowded market places); checking behaviors (e.g., checking doors, windows, locks, and perimeters more often than necessary); reassurance seeking (e.g., excessively watching the news); other compulsive behaviors (e.g., checking the location of exits); use of companions (e.g., relying on someone to attend a social gathering); and use of alcohol and certain substances (e.g., consuming alcohol to reduce anxiety).
15792134|NCT04515758|Other|Exercise and Cognitive Training|Exercise: 12-week, twice-weekly 60-minute program. Each session includes a brief 5 minute educational lesson on a health-related topic (i.e. healthy eating, good posture, etc.). Each participant receives individualized and progressive exercise program from qualified exercise providers (YMCA instructors). The programs include whole body exercises including squats, rows, chest press, bicep/tricep exercises, shoulder exercises, and core exercises. A 5 warm-up is done (individually or in a group) and a 5 minute group cool-down (stretching) is done each class. Cognitive training: focuses on dual-task training (provided by an Android tablet). Each cognitive task requires the participant to choose and execute the response appropriate for the stimuli presented. Participants must prioritize their response and perform tasks as fast as possible while maintaining accuracy. The difficulty of the training is individualized and progressive based on their ongoing performance.
15792135|NCT04515758|Other|Exercise Training Only|Exercise: 12-week, twice-weekly 60-minute program. Each session includes a brief 5 minute educational lesson on a health-related topic (i.e. healthy eating, good posture, etc.). Each participant receives individualized and progressive exercise program from qualified exercise providers (YMCA instructors). The programs include whole body exercises including squats, rows, chest press, bicep/tricep exercises, shoulder exercises, and core exercises. A 5 warm-up is done (individually or in a group) and a 5 minute group cool-down (stretching) is done each class.
15792136|NCT04515745|Behavioral|Intensive lifestyle intervention (ILI)|Lifestyle intervention focused on weight loss through diet and physical activity
15792137|NCT04515745|Behavioral|Diabetes support and education (DSE)|Behavioral intervention focused on diabetes support and education
15792138|NCT04515732|Drug|Apremilast Oral Tablet|As in description
15792139|NCT04515719|Biological|Belimumab|Belimumab 2mg/kg intravenously
15792140|NCT04515719|Biological|Placebo|Placebo intravenously
15792141|NCT04515706|Drug|Iguratimod|Iguratimod is an anti-rheumatic drug that approved for treating rheumatoid arthritis in East Asia. Recent data reveal its independent anti-fibrosis effect.
15792142|NCT04515706|Drug|Placebo|Placebo of Iguratimod
15792148|NCT04515628|Drug|Rosuvastatin|Specified dose on specified days
15792150|NCT04515615|Drug|Camrelizumab|Camrelizumab, 200 mg IV for 30-60 min in first day every 3 weeks. Repeated every 21 days. 21 days for a cycle.
15792151|NCT04515615|Drug|Oxaliplatin|Oxaliplatin: 130 mg/m^2 IV for 2-6 hour in first day which will be administered at least 30 min after completion of camrelizumab administration, every 3 weeks. Repeated every 21 days, 21 days for a cycle.
15792152|NCT04515615|Drug|Tegafur gimeracil oteracil potassium capsule|Tegafur gimeracil oteracil potassium capsule: 80 mg/m^2 twice daily (BID) by continuous oral administration for 14 days, followed by a recovery period of 7 days. Repeated every 21 days. 21 days for a cycle.
15792153|NCT04515602|Procedure|Primary debulking surgery|Primary debulking surgery with a maximum cytoreduction, then followed by 6 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5.
15792154|NCT04515602|Procedure|Neoadjuvant chemotherapy|3 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5, Interval debulking surgery with a maximal cytoreduction of complete gross resection, then followed by another 3 cycles of chemotherapy.
15792155|NCT04515602|Drug|PARPi|For patients with gBRCA/sBRCA mutation and CR/PR after first-line chemotherapy, maintenance therapy of PARP inhibitors.
15792156|NCT04515576|Drug|LY3493269|Administered SC
15792157|NCT04515576|Drug|Dulaglutide|Administered SC
15792158|NCT04515576|Drug|Placebo|Administered SC
15792159|NCT04515563|Behavioral|Stretching exercise|Control Group
15792160|NCT04515563|Behavioral|Low-frequency, moderate-intensity walking group|once-a-week walking exercise at moderate intensity
15792161|NCT04515563|Behavioral|High-frequency, moderate-intensity walking group|thrice-a-week walking exercise at moderate intensity
15792162|NCT04515563|Behavioral|Low-frequency, vigorous-intensity walking group|once-a-week walking exercise at vigorous intensity
15792163|NCT04515563|Behavioral|High-frequency, vigorous-intensity walking group|thrice-a-week walking exercise at vigorous intensity
15792164|NCT04515550|Diagnostic Test|lumbar puncture|Some participants will have an optional lumbar puncture
15792165|NCT04515537|Dietary Supplement|Water-soluble Extract of the Cyanophyta Aphanizomenon Flos-aquae (AFA),|Patient use 2 capsules 3 time a day by oral.
15792166|NCT04515537|Procedure|Infiltrtion of SVf|After filling up the informed consent Mini liposuction is performed under local anesthesia with klein solution, about 70 cc of dry fat tissue is suctioned and collagenase digestion is done with final centrifugation to obtain the SVF
15792168|NCT04515511|Other|4% gelatin|Pulmonary artery catheter insertion is prepared before fluid challenge. Baseline hemodynamic value and each time after 5 sequential intravenous boluses of 100 mL colloid are recorded.
15792169|NCT04515498|Device|CloudCath Monitoring System|The CloudCath Monitoring System will analyze effluent dialysate for changes associated with peritonitis.
15792170|NCT04515472|Drug|Botnia Clamp|This clamp technique is designed to obtain independent measures of insulin secretion and insulin sensitivity during the same test. In brief, 0.3g/kg body wt of a 20% glucose solution is given at time 0. Blood samples for the measurement of plasma glucose and serum insulin are obtained at -10, 0, 2, 4, 6, 8, 10, 20, 30, 40, 50, 60, 120, and 180 min.
15792171|NCT04515472|Other|Withdrawal of Gender Affirming Hormone Therapy (GAHT)|GAHT, either estrogen or testosterone therapy will be withdrawn after the Botnia Clamp.
15792172|NCT04515459|Other|Surgical prehabilitation program.|"This programme will include the practice of general physical activity and the implementation of nutritional and psychological support.
~Each patient will have 8 Oncorehabilitation Transdisciplinary Evaluations (OTE):
~2 OTE will be performed before the surgery,
~6 OTE will be performed after the surgery.
~During the program (at each OTE), patients will also be asked to complete the QLQ-C30 questionnaire."
15792173|NCT04515446|Diagnostic Test|Rapid test for diagnosis orientation|Rapid tests screen for influenza viruses in less than 30 minutes. They detect internal viral nucleoproteins by immunochromatography using specific antibodies attached to one or more strips.
15792174|NCT04515446|Diagnostic Test|quantitative PCR|Molecular biology method of gene amplification in vitro. It allows a large number of known DNA or RNA sequences to be duplicated
15792175|NCT04515433|Device|Gamma tACS (40 Hz) over the superior parietal cortex|Single session of gamma tACS (40 Hz) over the superior parietal cortex
15792176|NCT04515420|Drug|noradrenaline|noradrenaline infusion
15792177|NCT04515407|Other|PAS at Rest|Paired Associative Stimulation will be delivered while the participant is seated and resting.
15792178|NCT04515407|Other|PAS - Active|Paired Associative Stimulation will be delivered while the participant is seated and producing submaximal background activity in the plantarflexor muscles.
15792179|NCT04515407|Other|PAS - Walking|Paired Associative Stimulation will be delivered while the participant is walking, during the late stance phase of the gait cycle.
15792182|NCT04515381|Other|Therapeutic Touch|Therapeutic Touch
15792183|NCT04515381|Other|Control group|Making measurements at the beginning of the research and 4 weeks
15792184|NCT04515381|Other|Sham Therapeutic Touch|Sham Therapeutic Touch
15792185|NCT04515368|Biological|Immunization|Immunisation with one of four licensed vaccines
15792186|NCT04515355|Behavioral|Ready for MS|Receive 'ready for MS' programme in addition to standard care.
15792187|NCT04515342|Diagnostic Test|DXA|Each participant will undergo one DXA scan
15792656|NCT04511468|Other|Placebo|Placebo with inactive ingredients
15792188|NCT04515342|Other|Muscle strength and function assessment|Each patient will have their muscle strength and function assessed with the measurements of handgrip strength, 10 m gait speed and a 30 s sit-to-stand test. They will also fill out a questionnaire assessing Strength, Assistance in walking, Rise from a chair, Climb stairs, and Falls (SARC-F questionnaire).
15792189|NCT04515342|Other|Blood samples|Each patient will undergo a physical examination and also deliver blood samples.
15792190|NCT04515329|Drug|Cyclosporine|Eye drops taken twice daily.
15792191|NCT04515329|Drug|Artificial tear|Preservative-free artificial tear drops 4 times a day.
15792192|NCT04515316|Device|OPM sensors|Optically-pumped magnetometers (OPM) sensors, which are based on optical probing of alkali atoms in the vapor phase at (or slightly above) room temperature, have recently demonstrated sensitivity levels comparable with SQUID magnetometers in the laboratory. These sensors require no cooling and can potentially be fabricated at much lower cost than SQUIDs. Beginning in the late 1990s, optically-pumped magnetometers began to be used for biomagnetic applications, first for measurement of heart magnetic fields and more recently for measurement of brain fields by several groups around the world.
15792193|NCT04515316|Device|SQUID sensors|Magnetic sensors based on superconducting quantum interference devices (SQUIDs) have been the dominant sensor in the field of magnetoencephalography since its birth in the early 1970s. SQUIDs have exceptional sensitivity to enable the detection of these very weak signals. Current FDA-approved MEG devices contain liquid helium gas in a big container that is mounted over the head of the subject
15792194|NCT04515303|Other|Diverse Intervention Participation in DASH|A qualitative examination of barriers and facilitators of the DASH dietary pattern, and quantitative investigation of the types of recruitment methods effective for black adults entering a digital DASH-promoting intervention.
15792195|NCT04515290|Drug|TSG-01|Two tablets of TSG-01 (0.35g/tablet) were given by oral with 3 times a day for 12 weeks; High dose group.
15792196|NCT04515290|Drug|TSG-01 and Placebo|One tablet of TSG-01 (0.35g/tablet) and one tablet of placebo (0.35g/tablet) were given by oral with 3 times a day for 12 weeks; Low dose group.
15792197|NCT04515290|Drug|Placebo|Two tablets of placebo (0.35g/tablet) were given by oral with 3 times a day for 12 weeks.
15792198|NCT04515277|Dietary Supplement|40 g Gum acacia (FibregumTM)|Applied in 300 mL of orange juice with breakfast (single use at visit)
15792199|NCT04515277|Dietary Supplement|20 g Gum acacia (FibregumTM)|Applied in 300 mL of orange juice with breakfast (single use at visit)
15792200|NCT04515277|Dietary Supplement|0 g Gum acacia (FibregumTM)|300 mL of orange juice with breakfast (single use at visit)
15792201|NCT04515251|Diagnostic Test|Ultrasound measurements|ultrasound measurement at the level of the left renal vein on a sagittal plane according to age
15792202|NCT04515238|Drug|Bendamustine|Debulking: Cycles 1-2: d1+2 - 70mg/m² i.v.
15792203|NCT04515238|Biological|Obinutuzumab|"Induction: Cycle 1: d1 - 100 mg, d1 (or d2) - 900 mg, d8 + d15 - 1000 mg i.v.; Cycle 2 - 6: 1000 mg, d1 i.v.
~Maintenance: Cycle 1 - 8: 1000 mg, d1 i.v."
15792204|NCT04515238|Biological|Zanubrutinib|"Induction: Cycle 1: --; Cycles 2 - 6: d1-28: 2 x 160mg p.o.
~Maintenance: Cycle 1 - 8: d1-84: 2 x 160mg p.o"
15792205|NCT04515238|Biological|Venetoclax|"Induction: Cycles 1 + 2: --; Cycle 3: d1-7: 20mg, d8-14: 50mg, d15-21: 100mg, d22-28: 200mg p.o.; Cycle 4 - 6: d1-28: 400 mg p.o.
~Maintenance: Cycle 1 - 8: d1-84: 400 mg p.o."
15792206|NCT04515225|Other|Blood Sample|Blood Sample
15792207|NCT04515212|Other|Optic Nerve Ultrasounds|Patients will have up to four ultrasounds of the optic nerve.
15792211|NCT04515173|Diagnostic Test|Artificial intelligence diagnosis and treatment assistance system|An artificial intelligence robot that can assist psychiatrists in disease screening, diagnosis, treatment, and follow-up.
15792212|NCT04515160|Diagnostic Test|Clinical Frailty Scale|Clinical fragility scale will be recorded in the first 24 hours of intensive care admissions.
15792213|NCT04515160|Diagnostic Test|Modified Frailty Index|Modified Frailty Index will be recorded in the first 24 hours of intensive care admissions.
15792214|NCT04515147|Biological|CVnCoV 6 μg|Participants will receive an intramuscular injection by needle in the deltoid area.
15792215|NCT04515147|Biological|CVnCoV 12 μg|Participants will receive an intramuscular injection by needle in the deltoid area.
15792216|NCT04515147|Biological|Hepatitis A vaccine|Participants will receive an intramuscular injection by needle in the deltoid area.
15792217|NCT04515147|Biological|Pneumococcal vaccine|Participants will receive an intramuscular injection by needle in the deltoid area.
15792218|NCT04515147|Biological|CVnCoV 12μg|Participants will receive an intramuscular injection by needle in the deltoid area.
15792219|NCT04515134|Diagnostic Test|assessment of follicular level of coenzyme Q10 in the ovaries in females undergoing ICSI|human coenzyme Q10 (CoQ10) ELISA kit
15792220|NCT04515121|Device|HD-tCES|The high definition transcranial electrical stimulation was applied using a 1*4 ring electrode configuration. The anodal electrode was placed on the ipsilesional C1/C2, and the remaining 4 cathodal electrodes were placed in a radius of approximately 7.5 cm from anode (Cz, F3, T7, and P3 on the left hemisphere or Cz, F4, T8, and P4 on the right hemisphere). HD-tCES will be applied for 20 minutes at an intensity of 1.0 mA direct current stimulation and a specific-added waveform each time, 3 times a week, lasting for 4 weeks.
15792221|NCT04515121|Device|Sham HD-tCES|The high definition transcranial electrical stimulation was applied using a 1*4 ring electrode configuration. The anodal electrode was placed on the ipsilesional C1/C2, and the remaining 4 cathodal electrodes were placed in a radius of approximately 7.5 cm from anode (Cz, F3, T7, and P3 on the left hemisphere or Cz, F4, T8, and P4 on the right hemisphere). Sham HD-tCES will consist of a 5-second ramp up to 1.0 mA direct current stimulation and a specific-added waveform followed immediately by a 5-second ramp down, no current in the middle 19 minutes 40 seconds, and a ramp-up and ramp-down period during the last 10 seconds.
15792222|NCT04515121|Other|Lower limb rehabilitation|Lower limb rehabilitation programs will be selected and graded in accordance with each patient's lower limb function and specific aims of activities of daily living. Lower limb rehabilitation will be provided for 30 minutes each time, 3 times a week, lasting for 4 weeks.
15792657|NCT04511455|Drug|Cabozantinib|Cabozantinib 60 mg/day peroral
15792223|NCT04515108|Other|Clinical assessment|Perinatal outcomes and diagnostic value of hematologic parameters were compared between pregnancies with and without COVID-19.
15792224|NCT04515095|Other|Water-only Fasting|Participants consume only water for at least 7 days in an in-patient, residential setting with 24 hour medical supervision.
15792225|NCT04515082|Diagnostic Test|Stool-based SDC2 and SFRP2 DNA methylation test|A diagnostic device measuring syndecan 2 (SDC2) and secreted frizzled-related protein 2 (SFRP2) methylation status in stool DNA to detect colorectal cancer
15792226|NCT04515082|Diagnostic Test|FIT|Fecal immunochemical test
15792227|NCT04515069|Procedure|traditional technique of tooth preparation|"Depth cutter wheels of predetermined depths (Komet, Germany) were used to perform the preparation directly on the tooth structure.
~Depth cuts were performed on the labial surface using depth cutter wheels (Komet, Germany) with radius of 0.3 mm and 0.5 mm which is directly related to the thickness of the laminate veneers in the cervical and incisal one thirds respectively. Then islands of tooth structure between depth orientation grooves were removed.
~Proximal reduction:
~The interproximal reduction was completed just labial to the contact areas using a round end tapered diamond stone (Mani, Japan), and polishing was performed using polishing strips (Sof-Lex, 3M ESPE, Seefeld, Germany).
~Incisal reduction:
~Vertical depth grooves were created. Then, the round end tapered diamond stone (Mani, Japan)was used to create 1.5 mm incisal butt joint preparation.
~Then, finishing and polishing of tooth preparation was performed."
15792228|NCT04515069|Procedure|aesthetic preevaluative temporary technique for tooth preparation|"The data obtained from digital smile design was used for construction of the diagnostic wax-up. The wax-up was then be transferred to the mouth using a silicone index, creating the aesthetic pre-evaluative temporary (APT). The APT was tested esthetically and functionally. Once approved by the operator and the patient, tooth preparation was performed through the APT. Depth cuts were performed similar to those performed in the traditional preparation with the difference of being prepared on the aesthetic pre-evaluative temporary instead of directly on the dental structure. Using tapered stone with round end (Mani, Japan), islands of tooth structure between depth orientation grooves were removed.
~Proximal reduction, Incisal reduction Finishing and polishing of tooth preparation were carried out using the same technique as in the Group T with the difference of being performed through the APT, resulting in minimal tooth preparation"
15792229|NCT04515056|Drug|Papain 10 µg|The area will be exposed to 10 µg of papain.
15792230|NCT04515056|Drug|Papain 50 µg|The area will be exposed to 50 µg of papain.
15792231|NCT04515056|Drug|Papain 100 µg|The area will be exposed to 100 µg of papain.
15792232|NCT04515056|Other|Vehicle|The area will be exposed to vehicle
15792233|NCT04515056|Drug|Papain 1 SPT|Papain will be applied by 1 SPT prick thought the skin
15792234|NCT04515056|Drug|Papain 5 SPT|Papain will be applied by 5 SPT pricks thought the skin
15792235|NCT04515056|Drug|Papain 25 SPT|Papain will be applied by 25 SPT pricks thought the skin
15792236|NCT04515056|Other|Cowhage|The last area will be exposed to cowage spicules (made chemically inert by autoclaving) soaked in 5 mg/ml papain solution.
15792237|NCT04515043|Drug|INVAC-1 given in the previous phase 1 NCT02301754. No new injection is required in this study.|blood sampling will be drawn once in order to analyse long term memory immune response to INVAC-1 vaccine
15792238|NCT04515004|Drug|leucoselect phytosome|A standardized grape seed procyanidin extract complexed with soy phospholipid.
15792239|NCT04514991|Device|Foundation|Collagen-based, bone filling augmentation material used to stimulate bone formation in extraction sockets or bone defects in the alveolar ridge.
15792240|NCT04514978|Procedure|Blood donation and blood transfusion|24 subjects (12 female, 12 male) is phlebotomized and four weeks later ~130 mL packed red blood cells are re-infused in the same subjects.
15792241|NCT04514965|Other|Blood sampling|Blood sampling
15792242|NCT04514965|Device|Fibroscan|Measurement of liver stiffness
15792243|NCT04514965|Other|Question|Question about pruritus
15792244|NCT04514952|Biological|HB-adMSCs|Hope Biosciences autologous adipose-derived mesenchymal stem cells
15792245|NCT04514939|Other|Elevation of the legs during bed rest|Patients of Group A will will lie in their hospital bed with a moderate leg elevation (between 15 and 30 degrees)
15792246|NCT04514913|Radiation|Multidetector Computed Tomography (MDCT) Scan|This is a low-dose CT scan of the chest using no contract material.
15792247|NCT04514913|Procedure|Virtual Navigation Bronchoscopy (VNB)|This is a procedure where a camera will be inserted into the lung in order to guide sample collection of bronchoalveolar lavages, bronchail brushes and endobronchial biopsies.
15792248|NCT04514900|Behavioral|Video Chat +Personalized Feedback|Participants will receive an online 16-session, goal-driven behavioral weight control program via video chat and weekly interactive modules. The modules provide evidence-based health education on caloric balance, with a goal of fostering changes in diet and exercise habits and producing weight losses of 5-10%. Participants are provided with an electronic scale that will transmit weights wirelessly to a secure study website. A group facilitator will monitor digital food diaries and provide detailed weekly feedback on diet and exercise.
15792249|NCT04514900|Behavioral|Video Chat + Basic Feedback|Participants will receive an online 16-session, goal-driven behavioral weight control program via video chat and weekly interactive modules. The modules provide evidence-based health education on caloric balance, with a goal of fostering changes in diet and exercise habits and producing weight losses of 5-10%. Participants are provided with an electronic scale that will transmit weights wirelessly to a secure study website. A group facilitator will monitor digital food diaries and provide basic weekly feedback on diet and exercise.
15792250|NCT04514900|Behavioral|Discussion Board for Social Support +Basic Feedback|Participants will receive an online 16-session, goal-driven behavioral weight control program via weekly interactive modules. The modules provide evidence-based health education on caloric balance, with a goal of fostering changes in diet and exercise habits and producing weight losses of 5-10%. They also are provided with a study discussion board for social support from fellow participants. Participants are provided with an electronic scale that will transmit weights wirelessly to a secure study website. A weight loss counselor will monitor digital food diaries and provide basic weekly feedback on diet and exercise.
15792342|NCT04514068|Procedure|Acupuncture|In each session, acupuncture are applied unilaterally or bilaterally on P6 acupoint. Each acupuncture needle will be stimulated by transcutaneous electric device.
15792343|NCT04514068|Procedure|Sham acupuncture|Sham acupuncture
15792251|NCT04514900|Behavioral|Discussion Board for Social Support+Personalized Feedback|Participants will receive an online 16-session, goal-driven behavioral weight control program via weekly interactive modules. The modules provide evidence-based health education on caloric balance, with a goal of fostering changes in diet and exercise habits and producing weight losses of 5-10%. They also are provided with a study discussion board for social support from fellow participants. Participants are provided with an electronic scale that will transmit weights wirelessly to a secure study website. A weight loss counselor will monitor digital food diaries and provide personalized, detailed weekly feedback on diet and exercise.
15792252|NCT04514887|Other|mild intraoperative hyperventilation|Intraoperative mechanical ventilation of patients was adjusted so that end-tidal CO2 readings lie between 30-32 mmHg
15792253|NCT04514874|Other|Questionnaire|Self-questionnaire about socio-demographical status, health status and lifestyle habits during and following the COVID-19 pandemic.
15792254|NCT04514861|Device|Wireless Lumee Oxygen Platform|The Lumee Oxygen Platform is designed to monitor oxygen dynamics with a hydrogel placed in subcutaneous tissue
15792255|NCT04514848|Device|INSTI Multiplex HIV-1/2 Syphilis AB test|For the detection of antibodies to syphilis and HIV
15792256|NCT04514848|Device|Multiplo Rapid TP/HIV test|For the detection of antibodies to syphilis and HIV
15792257|NCT04514835|Drug|Cisplatin+Capecitabine+Sintilimab|"The first stage:concurrent chemoradiotherapy，cisplatin，25-30mg/m2 ivgtt d1;capecitabine,800mg/m2, bid d1-5，qw，5weeks;concurrent radiotherapy,1.8-2Gy/d，5d/W，50-50.4Gy.
~second stage:Sintilimab, 200mg,q3w, a total of 3 times，Each infusion lasted for 30-60 min until disease progression or intolerable toxicity, with a maximum duration of no more than 12 months."
15792258|NCT04514822|Diagnostic Test|Dynamic PET|After transmission CT scan for subsequent PET data attenuation correction, continual dynamic clinical PET scans were performed in a single bed position immediately after 18F-FDG intravenously injection (210 ± 30 MBq) in list mode for 60 minutes in supine position, dynamic 48 time frames PET/CT imaging was obtained.And then underwent whole body static PET scan.
15792259|NCT04514809|Other|human milk analized|After birth (24-72 hours) 15 ml, and end of the first month of birth 30 ml of milk from the mother will be milked in the appropriate way and put into the sterile milk collection container. The milk taken into the milk transport container will be delivered to the Nutrition Lab for analysis (moisture, protein, fat, lactose) by the researcher who arrives at the TUBITAK Mam Research Center as fresh within 3 hours
15792260|NCT04514796|Drug|Adalimumab|SB5 (adalimumab), 40 mg, single-dose
15792261|NCT04514783|Device|Debridement with Debritom+ micro water jet device|"Visits to the outpatient wound-care center as directed by a physician. Wound care performed by the study nurse according to the study-protocol. Each necessary wound debridement will be the same and will be as follows:
~Removal of old dressing
~Woundworks® 3D imaging
~Applying analgesic if necessary
~Applying a soaked gaze with Sodium chloride (NaCl) 0.9% solution on the wound (5 minutes)
~Debridement using Debritom+ micro water jet technology
~Wound cleansing with NaCl 0.9% solution
~Woundworks® 3D imaging
~Application of new dressing (according to the wound healing phases, medical prescription)
~In the case debridement is no more required, wound dressing change will be performed as follows:
~Removal of old dressing
~Woundworks® 3D imaging
~Wound cleansing with NaCl 0.9% solution
~Application of new dressing (according to the wound healing phases, medical prescription)"
15792262|NCT04514783|Other|Debridement with|"Visits to the outpatient wound-care center as directed by a physician. Wound care performed by the respective study nurse according to the study-protocol. Each necessary wound debridement will be the same and will be as follows:
~Removal of old dressing
~Woundworks® 3D imaging
~Applying analgesic if necessary
~Applying a soaked gaze with NaCl 0.9% solution on the wound (5 minutes)
~Debridement using scalpel and curette
~Wound cleansing with NaCl 0.9% solution
~Woundworks® 3D imaging
~Application of new dressing (according to the wound healing phases, medical prescription)
~In the case debridement is no more required, wound dressing change will be performed as follows:
~Removal of old dressing
~Woundworks® 3D imaging
~Wound cleansing with NaCl 0.9% solution
~Application of new dressing (according to the wound healing phases, medical prescription)"
15792263|NCT04514770|Drug|Misoprostol|rupture of membrane early and late
15792264|NCT04514757|Device|active tVNS|20 Hz, 200 microseconds at a current just below discomfort threshold for one hour twice a day, starting on post-day 0. Stimulation will continue until 6 days post-operatively or discharge.
15792265|NCT04514757|Device|sham tVNS|Current set a 0 mA, starting on post-op day 0. Stimulation will continue until 6 days post-operatively or discharge.
15792266|NCT04514744|Procedure|Knee bracing|Participants will have one leg immobilized, by means of a removable Don Joy Knee Brace. Participants will be expected to keep the knee brace on for 8 days, completely prevent weight bearing on the immobilized leg, and use crutches.
15792267|NCT04514744|Other|Unilateral Resistance Exercise Training|Participants will perform resistance training on 4 occasions throughout an 8 day time period.
15792268|NCT04514731|Drug|Magnesium sulfate|Magnesium group receives magnesium sulfate (50 mg/kg) in 100 mL of isotonic saline over 15 minutes after spinal anesthesia, followed by a continuous magnesium sulfate infusion (15 mg/kg/hour) until the end of surgery.
15792269|NCT04514731|Drug|Isotonic Saline|Isotonic saline group receives the same volume of isotonic saline, administered according to the same methods as in the magnesium group.
15792270|NCT04514718|Device|Holmium laser|low energy holmium laser
15792271|NCT04514705|Other|Exercise|Exercise with treadmil and weight training station
15792272|NCT04514692|Diagnostic Test|FDG PET/CT|Fluorodeoxyglucose (FDG)-positron emission tomography (PET) and computed tomography (CT)
15792273|NCT04514692|Drug|GCSF|Granulocyte Colony Stimulating Factor (GCSF)
15792274|NCT04514679|Behavioral|Healthy Lifestyles Program|Regular group visits with a health coach in addition to routine dietician and clinician visits, reviewing successes and challenges from the previous session as well as data collected through self-monitoring
15792275|NCT04514679|Behavioral|Obesity Medicine Program|A tailored approach to obesity care for patients including individual dietician and health coach visits as appropriate.
15792276|NCT04514666|Other|Breath analysis|The breath of patients undergoing liver or kidney transplant will be sampled and volatile organic compounds will be identified
15792277|NCT04514653|Biological|RGX-314 Dose 1|AAV8 vector containing a transgene for anti-VEGF fab (Dose 1)
15792278|NCT04514653|Biological|RGX-314 Dose 2|AAV8 vector containing a transgene for anti-VEGF fab (Dose 2)
15792280|NCT04514640|Behavioral|The Calm app|"All participants (n=100) will be asked to download the Calm app to their phone. Participants will then receive an email containing 4-weeks of free access to Calm. All participants be asked to use Calm once per day for at least 10 minutes based on their group assignment (i.e., general meditation during daytime, sleep meditation before bed, or sleep stories before bed). Participants will be asked to turn on the take a moment feature in the Oura app in order for the Oura ring to collect neurophysiological measures before, during, and after meditations. Additionally, participants will be asked to complete sleep diaries every day throughout the intervention."
15792281|NCT04514627|Device|Auricular percutaneous neurostimulation|The BRIDGE/PENFS device manufactured by Key Electronics, consists of a battery activated generator and wire harness that connects to the generator. Four leads are also attached to the generator, each with a sterile 2 mm, titanium needle. The BRIDGE device settings are standardized and deliver 3.2 volts with alternating frequencies (1 ms pulses of 1 Hz and 10 Hz) every 2 s. This stimulation targets central pain pathways through branches of cranial nerves V, VII, IX, and X, which innervate the external ear. The PENFS device generator has a battery life of 5 days and delivers almost continuous stimulations throughout the 120 hours.
15792282|NCT04514614|Drug|68Ga-FAPI|Intravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-FAPI. Tracer doses of 68Ga-FAPI will be used to image lesions of arthritis by PET/CT.
15792283|NCT04514601|Other|Standard Operating Protocol|This was a written protocol on how the handover process should be conducted.
15792284|NCT04514588|Dietary Supplement|caffeine consumption|In this trial we are going to study the results of the consumption of 5mgr/kgr body weight of caffeine on appetite, food consumption and hormones ghrelin, asprosin, leptin and pancreatic polypeptide in relation to gene polymorphisms that affect caffeine metabolism and body weight
15792285|NCT04514575|Biological|Plasma transfusion|Transfusion of allogeneic fresh frozen plasma or cryoprecipitate
15792286|NCT04514562|Device|NeVa Stent Retrievers|mechanical neurothrombectomy
15792287|NCT04514549|Device|Emerald|The Emerald is a wireless sensor that can track the motion, breathing, and sleep of subjects without touching or requiring any interaction with the subjects, allowing them to go about their normal lives. The physical device is roughly a 30 x 35 x 5 cm box that contains directional antennas and a motherboard to process these signals. In typical operation, the device is mounted onto a wall within a clinic or home setting using peel-away (reversible) mount strips.
15792288|NCT04514536|Device|Health monitors|"The connected scale (iHealth HS2) measures weight from 5 to 180kg and BMI.
~The connected actimeter (iHealth AM4) monitors activity (number of steps, distance, calories), sleep (automatic sleep recognition, effective sleep time, number of awakenings) and swimming (automatic activity recognition, session duration, swim type recognition and number of laps).
~The connected blood pressure monitor (iHealth Track KN-550BT)is a medical device that measures blood pressure and pulse rate.
~The activity monitor (manufactured by RF Track) consists of a housing that can be positioned as a pendant or at the hip. It includes an accelerometer, gyroscope, magnetometer, barometer, radio transceiver, and led. The sensor records the raw signals.
~The touchpad allows the subject to connect to the Calliope app. This app allows the data recovery, storage, analysis, visualization, and all the required settings for the platform to work together."
15792289|NCT04514523|Other|QBSAfe Toolkit|The QBSAfe toolkit focuses on palliating symptoms, alleviating burden of treatment, facilitating social connections, and optimizing treatment safety.
15792292|NCT04514497|Drug|Elimusertib|Given PO
15792293|NCT04514497|Drug|Irinotecan Hydrochloride|Given IV
15792294|NCT04514497|Drug|Topotecan Hydrochloride|Given IV
15792297|NCT04514471|Other|Unventilated filter cigarettes|Currently marketed unventilated cigarettes
15792298|NCT04514471|Other|Ventilated filter cigarettes|Currently marketed ventilated cigarettes
15792299|NCT04514458|Other|Best practice alert for the notification of patient HFrEF and recommended evidence-based therapies (NO drugs are being administered in this trial)|Providers will receive a best practice alert for each of their eligible patients upon opening of the order entry screen in the patient's medical record. The alert will inform the provider to the presence of HFrEF and of the patient's current left ventricular ejection fraction and current evidence-based medications for HFrEF. It will also provide access to an order set with recommended evidence-based HFrEF therapies as well as a link to the best available guideline-recommended information regarding the treatment of heart failure.
15792300|NCT04514445|Other|Observational|
15792301|NCT04514432|Other|Music|If patients experienced agitation, they were able to request to listen to music for 30 minutes. They listened to genre playlists generated by the music application Spotify.
15792302|NCT04514419|Drug|HS627|Prior to surgery: trastuzumab, HS627, and docetaxel for 4 cycles (1 cycle = 21 days).
15792303|NCT04514419|Drug|Pertuzumab|Prior to surgery: trastuzumab, Pertuzumab, and docetaxel for 4 cycles (1 cycle = 21 days).
15792304|NCT04514406|Device|APERTO OTW DCB|Drug Coated Balloon Angioplasty
15792305|NCT04514393|Drug|Methotrexate|Intravenous methotrexate at 3.5g/m2 (standard hydration/leucovorin support) will be given on day 1 of all cycles，for up to 4 cycles.
15792306|NCT04514393|Drug|Ibrutinib|Oral ibrutinib will be given at a dose of 560 mg daily and will be continued daily after completion of methotrexate and temozolomide.Ibrutinib is continued until disease progression, intolerable toxicity or death.
15792307|NCT04514393|Drug|Temozolomide|Oral temozolomide will be given at 150mg/m2 from day1 to day 5 every 4 of all cycles，for up to 4 cycles.
15792308|NCT04514380|Other|Carbohydrate fluid|400 mL carbohydrate fluid
15792309|NCT04514380|Other|Non-carbohydrate fluid|0 mL carbohydrate fluid
15792310|NCT04514367|Drug|ANX005|Intravenous Infusion
15792344|NCT04514055|Procedure|De-epithelialized connective tissue graft wall|A de-epithelialized free gingival connective tissue graft will be used to treat Cairo's recession type 2 and type 3 associated with inta-bony defects
15792780|NCT04510350|Other|Biomarkers analysis|Genetic analysis of regions of interest
15792311|NCT04514354|Behavioral|GEST|On either Visit 3 or 4, subjects performed a maximal cardiopulmonary GEST following the Balke protocol. Immediately prior to the GEST, the study physician or his designee performed a brief physical examination, in which BP was assessed and all relevant medical information (i.e. medical history, medications, family history) were reviewed. The physician who completed the physical examination remained present during the GEST to monitor the subjects' electrocardiogram (ECG) and other physical signs. After the GEST was completed, the study physician reviewed the ECG for signs of ischemia. Breath-by-breath analysis of expired gases (i.e. oxygen and carbon dioxide) (ParvoMedicsTruneOne® 2400 Metabolic Measurement System, ParvoMedics Inc., Sandy, UT) determined maximal oxygen uptake (VO2max). Heart rate was measured continuously with a 12-lead ECG system and BP was measured by auscultation every 3 minutes during the GEST.
15792312|NCT04514328|Device|cerebral 18F-FDG PET-CT|cerebral 18F-FDG PET-CT exam after walking in the garden while 2 weeks (75 minutes/per day from Monday to Friday)
15792313|NCT04514315|Procedure|Minimally invasive cardiac valvular surgery|Minimally invasive valve surgery via right mini-thoracotomy.
15792314|NCT04514315|Procedure|Conventional cardiac valvular surgery|Conventional valve surgery via full median sternotomy
15792317|NCT04514289|Drug|Indocyanine green solution|Indocyanine green (ICG) is a cyanine dye used in medical diagnostics.ICG is a fluorescent dye that is used in medicine as an indicator substance.
15792318|NCT04514276|Other|consecutive fetoneonatal healthcare pathway|(1) early perceiving of pregnant women with higher risks for early fetal growth restrictions via color Doppler sonography, fetal biometry, haemogram check (currently additional screenings) (2) structured care of the high risk women who are pregnant (3) concerted neonatal health care (4) adapted paediatric aftercare, certain dates and responsible persons are scheduled.
15792319|NCT04514263|Other|OHIP-14 Administration|All patients fulfilled the OHIP-14 questionnaire three times: six hours, seven days and twenty-one days after the biopsy
15792320|NCT04514263|Other|VNS Administration|All patients fulfilled the VNS scale three times: six hours, seven days and twenty-one days after the biopsy
15792321|NCT04514237|Drug|BOS172767 enantiomer E1 or E2|Oral tablets
15792322|NCT04514237|Drug|Placebo|Oral tablets
15792323|NCT04514224|Other|Gabby implementation|Iimplement an evidence-based preconception care intervention, Gabby, into community-based health settings
15792324|NCT04514224|Other|Evaluate the Gabby implementation|Assess implementation outcomes using the Proctor Implementation Outcomes Framework
15792325|NCT04514211|Drug|Propofol|General anesthesia using propofol infusion
15792326|NCT04514211|Drug|Sevoflurane|General anesthesia using sevoflurane
15792327|NCT04514185|Device|Passive industrial exoskeleton for the upper limb|The goal is to compare the human response to the simulated industrial tasks
15792328|NCT04514185|Other|The protocol will be performed without exoskeleton|The protocol will be performed without exoskeleton
15792329|NCT04514172|Device|Passive industrial exoskeleton for back support|The goal is to compare the human response to the simulated industrial tasks
15792330|NCT04514172|Other|The protocol will be performed without exoskeleton|The protocol will be performed without exoskeleton
15792331|NCT04514159|Drug|ZN-c5|ZN-c5 is the study drug.
15792332|NCT04514159|Drug|Abemaciclib|Abemaciclib (VERZENIO®) is an approved drug.
15792333|NCT04514146|Other|Water-only fasting|In-patient water-only fasting for at least 10 days followed by at least 5 days of refeeding
15792334|NCT04514133|Behavioral|Participating in Action Civics program|Students in school classrooms participating in Action Civics program
15792335|NCT04514120|Other|AJESS scoring process|We will collecto endoscopic pictures from stable and non stable participants. Pictures will be taken for each sinus, olfactory cleft, and middle meatus in private clinical exam rooms. For each anatomic site [left middle meatus (LMM), left ethmoid sinus (LES), left frontal sinus (LFS), left maxillary sinus (LMS), left olfactory cleft (LOC), left sphenoid sinus (LSS), right middle meatus (RMM), right ethmoid sinus (RES), right frontal sinus (RFS), right maxillary sinus (RMS), right olfactory cleft (ROC), right sphenoid sinus (RSS)], numerical scores describe edema or polyposis while alphabetical scores, in lower case or upper case corresponding to severity, describe CRS features: crusting, synechiae, purulence, mucus, recirculation, and ostial narrowness.
15792336|NCT04514107|Other|Brazilian National Dengue Control Program|This program has 4 basic principles: 1) Adequate case finding, classification and treatment; 2) Epidemiological surveillance and reporting of all cases; 3) Mobilization and communication of risks to the public; 4) mosquito monitoring and control which consists fundamentally of detection of larva using a rapid larval index (LIRAa) followed by removal of breeding sites and local spraying.
15792337|NCT04514107|Other|Wolbachia-infected Aedes aegypti|Brazilian strain of Aedes aegypti infected with Wolbachia pipientis released into geographic clusters.
15792338|NCT04514094|Drug|SDF|SDF promotes enamel and dentin remineralization, as well as inhibit the growth of cariogenic bacteria. the Food and Drug Administration (FDA) approved SDF as a device for reducing tooth sensitivity in the USA.
15792339|NCT04514094|Procedure|ART|The ART technique involves caries excavation by hand instruments only with care to avoid pulp exposure. Such excavation is mainly from the periphery of the lesion to achieve a good seal of the restoration and minimize leakage. The tooth is then restored by glass ionomer cement.
15792340|NCT04514081|Drug|Chidamide; Decitabine; Camrelizumab|"Chidamide is a novel and orally active benzamide class of HDAC inhibitor that selectively inhibits activity of HDAC1, 2, 3 and 10, which can Induce tumor-cell apoptosis, suppress cell proliferation and enhance immune surveillance.
~Decitabine is an investigational (experimental) drug that works by depleting DNA methyltransferase 1(DNMT1), which can increase tumor antigens and HLA expression, enhances antigen processing, promotes T cell infiltration, and boosts effector T cell function.
~Camrelizumab is a humanized anti-PD-1 monoclonal antibody."
15792341|NCT04514081|Drug|Decitabine+Camrelizumab|Decitabine+Camrelizumab
15792437|NCT04513340|Drug|WD-1603 CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS|CARBIDOPA and LEVODOPA EXTENDED-RELEASE TABLETS 25/100MG
15792345|NCT04514042|Procedure|Peroral endoscopic myotomy|Patients will be hospitalized for 24 hours before procedure or at the day of procedure (depending on preference of each center). Procedures will be performed always using carbon dioxide insufflation and whenever possible under general anesthesia with endotracheal intubation by anesthesiologist recommendations. The procedure will begin after general endoscopic evaluation of the Zenker's diverticulum and esophagus. An incision of the bridge between the Zenker's diverticulum and the esophagus will be done using procedure as peroral endoscopic myotomy. All the procedures will be documented with photographs or videorecordings.
15792346|NCT04514042|Procedure|Flexible endoscopic septotomy|Patients will be hospitalized for 24 hours before procedure or at the day of procedure (depending on preference of each center). Procedures will be performed always using carbon dioxide insufflation and whenever possible under general anesthesia with endotracheal intubation by anesthesiologist recommendations. The procedure will begin after general endoscopic evaluation of the Zenker's diverticulum and esophagus. An incision of the bridge between the Zenker's diverticulum and the esophagus will be done using procedure as flexible endoscopy septotomy. All the procedures will be documented with photographs or videorecordings.
15792347|NCT04514029|Drug|Simvastatin|Simvastatin 40 mg started 2 weeks (+/-5 days) prior to apheresis through day +30
15792348|NCT04514029|Drug|Dexamethasone|Intrathecal dexamethasone 8 mg on days -1, +6, +13 (+/-2 days)
15792349|NCT04513990|Procedure|Biospecimen Collection|Undergo collection of nasopharyngeal, oral, saliva, and nasal samples
15792350|NCT04513990|Other|Questionnaire Administration|Demographic information, sample collection type preferences; clinical outcome information
15792351|NCT04513977|Other|Geriatric Oncology Supportive Clinic|Patients will undergo Comprehensive Geriatric Assessment with subsequent tailored intervention based on deficits identified. Comprehensive palliative assessment for any symptom burden and symptommatic treatment will be done as well.
15792352|NCT04513951|Drug|5Fluorouracil|phase II
15792353|NCT04513951|Drug|L-leucovorin|phase II
15792354|NCT04513951|Drug|Irinotecan|phase II
15792355|NCT04513951|Drug|Oxaliplatin|phase II
15792356|NCT04513951|Drug|Cetuximab|phase II
15792357|NCT04513951|Drug|Avelumab|phase II
15792358|NCT04513925|Drug|Atezolizumab|Atezolizumab 1680 mg every 4 weeks (Q4W) will be administered IV on Day 1 of each 28-day cycle.
15792359|NCT04513925|Drug|Tiragolumab|Tiragolumab 840 mg Q4W will be administered IV on Day 1 of each 28-day cycle.
15792360|NCT04513925|Drug|Durvalumab|Durvalumab will be administered based on weight at 10 mg/kg IV every 2 weeks (Q2W) on Days 1 and 15 of each 28-day cycle, or will be administered at a fixed dose of 1500 mg IV every 4 weeks (Q4W) (for participants whose weight >/= 30 kg) on Day 1 of each 28-day cycle.
15792365|NCT04513899|Behavioral|Community health worker (CHW)/ registered nurse (RN) [CHW/RN]|A team of 2-3 CHWs and a research RN will deliver all components of the program including daily DOT delivery of Direct Acting Antiviral (DAA) and assess HCV side effects all under the guidance of their RN. Recruitment will be continuous: each CHW may be assigned up to 7-8 participants every 2-3 months until the target sample size (n=54 for the intervention group) is achieved. After the first dose of the DAA, the CHW will run a brief weekly 1:1 education and case management session over the 8 or 12 weeks (total 20 minutes). The CHW/RN team will assist the participant in picking up the monthly medication and storing the medication in a secure, locked cabinet at the research office. The CHW will rigorously track participants who have missed a dose, and will also be involved in facilitating medical, mental health, substance use, social service, legal appointments for participants, housing referrals, and accompany the participants to the appointments.
15792366|NCT04513899|Behavioral|Clinic-based Standard of Care (cbSOC) Program (control group)|This program will be delivered by a clinic-based MD or clinic-based NP at the clinic site. Evaluation Staff (ES) will be hired and trained to do the interviewing/survey administration and follow-ups at the clinic-based site. The clinic NP will conduct, per usual care at the study clinics, the education and monitoring of these participants who will interact with the clinic-based-MD and/or NP monthly over the 8 or 12-week program. Usual care will include: 1) HCV pre-treatment education; 2) two month supply of DAA; 3) monitoring adverse events; and 4) responding to questions on HCV. Referral to drug/alcohol and housing programs will be provided over the standard of care. The cbSOC participants will not receive the community delivery of the DAA, or case management, or accompaniment to needed services. The cbSOC Program will receive the medication on a monthly basis from the clinic MD or NP.
15792367|NCT04513886|Procedure|Subepithelial connective tissue graft (SCTG) using the single incision technique, with and without suturing the palate|A SCTG was harvested using the single incision technique described by Hürzeler & Weng. The palatal incisions were standardized to extend between the area between mesial of the canine and mesial of the first molar.In the Suture Group sites a cross- mattress suture and interrupted single sutures were performed using nylon 5-0 when appropriate. In the no Suture Group sites, no suture was performed. In both groups, a CHS was placed after removing the graft to achieve the haemostasis of the palate and subsequent compressed with gauze soaked in saline for 5 minutes.
15792368|NCT04513873|Device|Equipment to divert the focus of children|The equipment was placed in an area where the children would be able to see easily during the blood collection process. It was turned on as soon as the children sat on to the chair where the process would take place to divert the focus of the children at the equipment.
15792369|NCT04513860|Drug|YKP3089|Capsule, dose to be titrated Tablet, dose to be titrated
15792370|NCT04513834|Other|GP will receive the educational outreach visit by a DAM (healthcare representative).|GP will receive the educational outreach visit by a DAM (healthcare representative).
15792371|NCT04513834|Other|Patient education material on PPI deprescribing will be sent to the patients|Patient education material on PPI deprescribing will be sent to the patients
15792372|NCT04513821|Drug|Mino-Lok Therapy (MLT)|Standard of Care antibiotics appropriate for the infecting organism plus Mino-Lok therapy to disinfect and save the catheter. Mino-Lok is made available through this expanded access protocol to patients who otherwise do not qualify for the phase 3 clinical trial (NCT02901717) Other Name: Standard of care antibiotics + Mino-Lok
15792373|NCT04513808|Drug|Propofol-based total intravenous anesthesia|Patients will normally be given dexamethasone 10 mg and ramosetron 0.3-0.6 mg prophylaxis for postoperative nausea and vomiting. Rescue treatment will be provided per clinical routine. Post-operative analgesia will be opioid-based, typically sufentanil and dezocine via patient-controlled pump. Analgesic adjuvants will be used per clinician preference.
15792374|NCT04513808|Drug|Sevoflurane intravenous anesthesia|Patients will normally be given dexamethasone 10 mg and ramosetron 0.3-0.6 mg prophylaxis for postoperative nausea and vomiting. Rescue treatment will be provided per clinical routine. Post-operative analgesia will be opioid-based, typically sufentanil and dezocine via patient-controlled pump. Analgesic adjuvants will be used per clinician preference.
15792375|NCT04513782|Diagnostic Test|Audiological Assessments|Participants will all undergo routine audiological assessments. The results from these assessments will be evaluated in order to advance understanding of central hearing loss.
15792376|NCT04513769|Behavioral|Vegan diet|Participants will receive a behavioral intervention on a vegan diet in partnership with a local vegan soul food restaurant
15792377|NCT04513756|Behavioral|Community Reinforcement Approach|Community Reinforcement Approach (CRA) as an intervention consisting of nine sessions (each session consists of 45-minutes). Treatment is primarily based upon the guidelines by Robert Meyers and William Miller (2001). The techniques included in the sessions are functional analysis, sobriety sampling, behavioral skills, and relapse prevention techniques. The first three sessions of the intervention are based upon rapport building, induction of the rationale of CRA and Functional analysis of usage and non-usage behavior.
15792378|NCT04513743|Diagnostic Test|24/7 EEG™ SubQ|24/7 EEG™ SubQ device will be worn by each subject for 365 nights
15792379|NCT04513730|Other|Rehabilitation|A device originally designed with the function of keeping the user in a comfortable position of pelvic suspension, in dorsal decubitus, with fixation in the popliteal region and ankles was built to promote lumbar traction. The device is designed in autoCAD software with 2d technical representations and 3d electronic model. It consists of a structure of pipes and fittings and padded material at the support points.
15792380|NCT04513717|Drug|Abiraterone Acetate|Given PO
15792381|NCT04513717|Drug|Apalutamide|Given PO
15792382|NCT04513717|Drug|Bicalutamide|Hormone therapy. Given PO
15792383|NCT04513717|Drug|Buserelin|Hormone therapy. Given by injection.
15792384|NCT04513717|Drug|Degarelix|Hormone therapy. Given by injection.
15792385|NCT04513717|Drug|Flutamide|Anti-androgen
15792386|NCT04513717|Drug|Goserelin|Anti-androgen
15792387|NCT04513717|Drug|Histrelin|Anti-gonadotropin
15792388|NCT04513717|Drug|Leuprolide|Hormone therapy.
15792389|NCT04513717|Drug|Prednisone|Given PO
15792390|NCT04513717|Other|Quality-of-Life Assessment|Ancillary studies
15792391|NCT04513717|Other|Questionnaire Administration|Ancillary studies
15792392|NCT04513717|Radiation|Radiation Therapy|Undergo radiation therapy
15792393|NCT04513717|Drug|Triptorelin|Anti-androgen
15792394|NCT04513704|Drug|Oral Semaglutide|Participants will receive oral semaglutide tablet once daily for 10 days (3 mg for first 5 days and 7 mg for the next 5 days).
15792395|NCT04513691|Diagnostic Test|EOS Calculator|Neonatal Early-Onset Sepsis Risk Calculator which is a tool that determines the risk of EOS for a particular newborn by looking at maternal risk factors and the newborn's clinical picture as opposed to just laboratory tests alone
15792396|NCT04513678|Behavioral|ImmunOncoTool Condition|Immunotherapy education + irAE monitoring + Facilitation of patient-provider communication
15792397|NCT04513665|Drug|ZW25|ZW25 at 20mg/kg intravenously (IV) every two weeks.
15792398|NCT04513652|Drug|AG-920|AG-920 Sterile Topical Ophthalmic Solution
15792399|NCT04513652|Drug|Placebo|Placebo Topical Ophthalmic Solution
15792400|NCT04513639|Drug|Early treatment of relapse with carfilzomib, dexamethasone, daratumumab|Second line treatment will start at MRD reapperance
15792401|NCT04513639|Drug|Standard treatment of relapse with carfilzomib, dexamethasone, daratumumab|Second line treatment will start at progressive disease
15792402|NCT04513626|Drug|DORAVIRINE 100 MG [Pifeltro]|Immediate switch
15792403|NCT04513613|Device|Procedure/Surgery: Robotic-PVI|Robotic-assisted (CorPath GRX System) percutaneous vascular interventions.
15792404|NCT04513600|Diagnostic Test|Cardiac MRI|Lab work: Hs- Troponin, Serum N-terminal-proBNP CMR: Native T1, Native T2, extracellular volume, strain and strain rate.
15792405|NCT04513587|Behavioral|CBT-based weight loss model|Methods of cognitive behavioral psychotherapy
15792406|NCT04513587|Behavioral|Control|Treatment as usual
15792407|NCT04513548|Drug|Ligelizumab|One injection every four weeks
15792408|NCT04513548|Drug|Placebo|One injection every four weeks
15792409|NCT04513535|Other|Thoracic Manipulation|A supine thoracic manipulation will be utilized. Participants will be lying supine on the plinth with their arms crossed over their chest, making sure the forearms are not crossed. An experienced clinician will place their hand on the inferior segment (T4); the superior segment (T3) will be placed in the midrange of thoracic flexion and extension. The clinician will apply a high velocity, end range, anterior to posterior thrust by using their body weight to deliver the thrust through the participants crossed elbows, thus creating a bilateral gapping of the facet joints. If a cavitation is achieved after the first thrust, the thoracic manipulation intervention is complete. If not, one more attempt will be made to achieve a cavitation. Regardless of if there was a cavitation or not, after the second attempt the intervention is complete.
15792438|NCT04513327|Device|Rehabilitation using Digital Healthcare System (Uincare Homeplus)|"Uincare Homeplus is a device using infrared, kinect camera and motion capture technology to track 3D motion of the patients' posture and joint articulations. It also has embedded exercise training software dedicated to anterior cruciate ligament reconstruction post-op rehabilitation at home.
~Home-based self-rehabilitation using brochure for 2 weeks post surgery (same as the active comparator)
~Home-based self-rehabilitation using digital healthcare system(Uincare Homeplus) for 2 to 12 weeks post surgery."
15792781|NCT04510337|Drug|standard rocuronium dose|0.6 mg/kg rocuronium during induction of anesthesia
15792410|NCT04513535|Other|Cervical Manipulation|Participants will be lying supine on the plinth on the table. A high velocity low amplitude manipulation will be performed to the cervical spine by an experienced clinician.The clinician will place the right proximal phalanx of the index finger over the posterolateral aspect of the articular pillar at the right C4/C5 segment to maximally influence the C5 myotomal distribution. The clinician's left hand will be cradling the participants head. The participant will be brought into midrange flexion-extension, ipsilateral side bend, and contralateral rotation of C4/5. Once a firm end feel is felt the manipulation will be administered into left rotation in an arc toward the left eye. If a cavitation is achieved after the first thrust, the intervention is complete. If not, one more attempt will be made to achieve a cavitation;after the second attempt the intervention is complete.
15792411|NCT04513535|Other|glenohumeral posterior glide mobilization|Participants will be instructed to lay supine on the plinth and a plastic orthopedic wedge will be placed under their scapula for stabilization on the side that is receiving the mobilization. The experienced clinician will stand on the same side being mobilized and held the participant's arm proximal to the medial and lateral humeral epicondyles. The clinician will hold the participant's arm in the scapular plane, approximately 55 degrees of abduction and slight ER with a grade one long axis distraction applied and sustained throughout the entire mobilization. A grade three oscillatory mobilization will be applied for three sets of 30 seconds with a 30 second rest in between.
15792412|NCT04513535|Other|Sleeper stretch|Participants will be positioned in a side lying position with the arm to be stretched on the table. The arm to be tested will then be positioned at a 90-90 shoulder abduction and elbow flexion position. A support will be positioned behind the patient to ensure there is no compensatory trunk movement during the stretch, and an examiner verified the arm is in a 90-90 position. A sleeper stretch will be subsequently completed, in which the participant will internally rotate the arm to stretch the posterior shoulder musculature. Three, thirty second stretches will be completed
15792413|NCT04513522|Biological|Nivolumab|Specified dose on specified days
15792414|NCT04513522|Biological|Ipilimumab|Specified dose on specified days
15792415|NCT04513509|Drug|Atenolol, Bisoprolol, Metoprolol, Nebivolol, Propranolol, Diltiazem, Verapamil, digoxin|Start with empirical lower dose for 3 months, and then titrate up
15792416|NCT04513483|Device|continuous positive airway pressure|CPAP treatment at night. Treat AF as cardiologist's discretion.
15792417|NCT04513483|Device|Placebo|Observation. Treat AF as cardiologist's discretion.
15792418|NCT04513470|Biological|Allocetra-OTS|Allocetra-OTS is a cell-based therapeutic composed of donor early apoptotic cells, comprising allogeneic mononuclear enriched cell suspension with at least 40% early apoptotic cells. The suspension is prepared with Ringer's lactate solution and administered IV. It is stored at 2-8°C until 20+25 minutes before infusion and at room temperature thereafter. Each dose contains 140x10E6 ± 20% cells/ kg of recipient body weight (at screening) in a total volume of 375 mL in a transfer pack that undergoes irradiation and is administered via an adjusted filter using a volumetric pump, at a starting rate of 48 mL/hour with a gradual increase every 15-25 minutes of 15 mL/hour to a maximal rate of 102 mL/hour. The study intervention should be completed within 72 hours of completing the manufacturing process. During product administration, no other IV fluids such as Ringer's lactate or normal saline will be given in parallel unless medically indicated due to volume depletion.
15792419|NCT04513457|Other|Liver resection and Neoadjuvant chemotherapy|
15792420|NCT04513457|Other|Liver resection and Adjuvant chemotherapy|
15792421|NCT04513457|Other|Liver resection, Neoadjuvant chemotherapy and Adjuvant chemotherapy|
15792422|NCT04513457|Procedure|Liver resection|
15792423|NCT04513444|Other|Relaxation with music listening and medical hypnosis during radiotherapy treatment:|"Music listening (According to the patient's wishes),
~Hypnosis sessions with the hypnotherapist during the 1st, 2nd and 3rd radiotherapy session,
~Self-hypnosis during the 4th and 5th radiotherapy session,
~Questionnaires (STAI-Y and QLQ-C30) and numerical scales (anxiety and pain) will be completed by patients during radiotherapy consultations."
15792424|NCT04513444|Other|Relaxation with music listening during radiotherapy treatment:|"Music listening (According to the patient's wishes),
~Questionnaires (STAI-Y and QLQ-C30) and numerical scales (anxiety and pain) will be completed by patients during radiotherapy consultations."
15792425|NCT04513431|Biological|Anti-CEA-CAR T|T cells modified with CEA targeted chimeric antigen receptor.
15792426|NCT04513418|Dietary Supplement|Preoperative immunonutrition|Preoperative immunonutrition includes an omega-3 fatty-acid enriched enteral nutritional emulsion given by oral intake, nasogastric feeding tube or jejunostomy 600ml per day, lasting from the start of neoadjuvant chemoradiotherapy until surgery. Meanwhile, oral intake is encouraged to reach 25-30kcal/kg through regular food.
15792427|NCT04513405|Diagnostic Test|Blood sampling|"a peripheral venous blood sample will be analyzed to measure the levels of estrone and estradiol.
~The sample of the blood sample will be deposited in the red cap tube with a polymeric gel."
15792428|NCT04513405|Procedure|Shave Biopsy|in the tissues, of the related estrogenic receptors, estrogen α receptors, estrogen β receptors (ER- α, ER-β) and G protein-coupled estrogen receptor 1 (GPER) correlates with the functional status of these receptors
15792429|NCT04513392|Procedure|Laser treatment|A flexible laser fiber will be utilized via a channelled laryngoscope to ablate the benign laryngeal lesions as per standard of care.
15792430|NCT04513379|Drug|Efavirenz 600mg|EFV 600 mg per day given orally
15792431|NCT04513379|Drug|Efavirenz 400mg|2 tablets of EFV 200 mg per day given orally
15792432|NCT04513366|Drug|SEL-212A|IV infusion of SEL-212A every 28 days for a total of up to 12 infusions
15792433|NCT04513366|Drug|SEL-212B|IV infusion of SEL-212B every 28 days for a total of up to 12 infusions
15792434|NCT04513366|Other|Normal Saline|IV infusion of Normal Saline every 28 days for a total of up to 12 infusions
15792435|NCT04513353|Device|Rehabilitation using Digital Healthcare System (Uincare Homeplus)|"Uincare Homeplus is a device using infrared, kinect camera and motion capture technology to track 3D motion of the patients' posture and joint articulations. It also has embedded exercise training software dedicated to total knee arthroplasty post-op rehabilitation at home.
~Home-based self-rehabilitation using brochure for 3 weeks post surgery (same as the active comparator)
~Home-based self-rehabilitation using digital healthcare system(Uincare Homeplus) for 3 to 12 weeks post surgery."
15792436|NCT04513353|Other|Conventional Rehabilitation|Home-based self-rehabilitation using brochure for 12 weeks post surgery.
15792443|NCT04513301|Drug|Sintilimab|Sintilimab (200 mg q3w ×2 cycle)
15792444|NCT04513301|Radiation|Radiotherapy|RT 50-60Gy/25-30f
15792445|NCT04513288|Dietary Supplement|Experimental treatment L-citrulline (Protéocit®)|Enteral administration of citrulline for 5 days.
15792446|NCT04513288|Other|Placebo treatment|Enteral administration of iso-nitrogenous placebo for 5 days.
15792447|NCT04513275|Drug|non-medicine intervention|rating by MCCB only one time
15792448|NCT04513262|Procedure|mechanical ventilation during video-assisted surgery|observed variation of ventilatory parameters during video-assisted surgery
15792449|NCT04513249|Diagnostic Test|dynamics of coagulation parameters|the effects of fresh frozen plasma administered during a plasma exchange therapy on viscoelastic tests
15792450|NCT04513236|Other|Pre-survey incentive|An incentive of is given in the form of airtime to motivate participants to complete the survey. Participants were sent 0.1X before the were sent a mobile phone survey and an additional 1X after completing the survey.
15792451|NCT04513236|Other|Post-survey incentive|An incentive in the form of airtime to motivate participants to complete the survey. Participants were given Bangladeshi Taka or Ugandan Shillings worth of certain airtime for completing the survey.
15792452|NCT04513223|Drug|SHR-A1811|There are six pre-defined dose regimens . Subjects will be enrolled with an initial dose
15792453|NCT04513184|Drug|IV Dexamethasone|6 mg from Day 1 to 10 after randomization
15792454|NCT04513184|Drug|Nasal Dexamethasone|0.12 mg/kg/daily for 3 days from day 1, followed by 0.06 mg/kg/daily from day 4 to 10 after randomization.
15792455|NCT04513171|Drug|Y-shape pegylated somatropin|Y-shape pegylated somatropin 100μg/kg, subcutaneous injection, Once weekly.
15792456|NCT04513171|Drug|Y-shape pegylated somatropin|Y-shape pegylated somatropin 120μg/kg, subcutaneous injection, Once weekly.
15792457|NCT04513171|Drug|Y-shape pegylated somatropin|Y-shape pegylated somatropin 140μg/kg, subcutaneous injection, Once weekly.
15792458|NCT04513171|Drug|Norditropin®|Norditropin 245μg/kg/week, subcutaneous injection, Once daily.
15792459|NCT04513171|Drug|Y-shape pegylated somatropin|Y-shape pegylated somatropin 140μg/kg, subcutaneous injection, Once weekly.
15792460|NCT04513171|Drug|Norditropin|Norditropin 245μg/kg/week, subcutaneous injection, Once daily.
15792461|NCT04513158|Biological|Convalescent Plasma|Plasma obtained from individuals previously diagnosed with SARS-CoV-2 (COVID-19) is administered to hospitalized patients meeting inclusion/exclusion criteria and have provided informed consent.
15792462|NCT04513145|Drug|Ropivacaine injection|Ropivacaine is a local anesthetic that is FDA approved for local anesthetic nerve block.
15792463|NCT04513145|Drug|Saline Injection|Saline will be used as a placebo injection
15792464|NCT04513145|Procedure|Total Knee Arthroplasty|All subjects participating in this study will undergo primary total knee arthroplasty
15792465|NCT04513132|Device|active-dTMS|The dTMS using H-coil with 20Hz stimulate mPFC. The sessions of dTMS will be conducted twice daily for 5 consecutive days, and twice sessions of a day will be separated by 3 hours at least.
15792466|NCT04513132|Device|sham-dTMS|The sham-dTMS has the same appearance with the real stimulation coil, which can not generate magnetic field. A sound generator is built in the coil beat to simulate the sound of the real stimulation.
15792467|NCT04513106|Behavioral|"ACP programme Have a Say"|It is a theory-driven advance care planning programme specifically designed for PWEDs or persons with MCI and their family caregivers. The intervention is underpinned by the Bandura's self-efficacy model. Each dyad of participants will receive a 3-session ACP programme, which consists of educational components, guided reflection, and dyadic ACP discussion, guided by ACP facilitators and an ACP booklet. It is composed of 1 group-based sessions and 2 dyadic discussions. One hour for each session, and once weekly. Dyads of participants will be provided with information about the trajectory of dementia, their future healthcare needs and caring options. Their values and care preferences on future care will be elicited in a consistent manner. They will be supported to have an individualized ACP discussion. By the end of the programme, each dyad of participant will be given an ACP booklet documenting the ACP process.
15792468|NCT04513106|Behavioral|Attention-control health talks|Dyads of participants in the control group will receive 3-session health talks. One hour for each session, and once weekly. The contents of the health talks are neither dementia-specific nor related to ACP, and cover general health information for elderly, such as drug safety, home safety, exercise and health. This is to differentiate the effect of the intervention from the effect of the extra time and attention given to the participants
15792469|NCT04513093|Other|Aromatherapy Massage|The elderly individuals in the intervention group underwent aromatherapy massage with ginger and lavender oils for a period of five days and 15 minutes on weekdays for four weeks according to the abdominal massage application protocol.
15792470|NCT04513080|Behavioral|Video-chat psychotherapy (VCP)|Video Chat Only (VCP) consists of weekly psychotherapy appointments that last between 30-45 minutes. These sessions are conducted using Agora, a secure, HIPAA-compliant video conferencing service that is seamlessly integrated into the Talkspace platform application. Therapists will provide evidence-based treatments for depression and anxiety.
15792471|NCT04513080|Behavioral|Message-based psychotherapy (MBP)|Message-Based Psychotherapy (MBP) allows patients to chat with an assigned licensed therapist as frequently as they wish. After consumers complete an intake and select a therapist, the consumer can begin chatting with their therapist right away, and as often as they wish. Therapists respond to text within 15 minutes to an hour during office hours, and within 14 hours outside of office hours. Thus, MBP is not fully synchronous. This enables therapists to deliver care to a larger number of patients than is possible under synchronous methods by disentangling the therapist's time from the patient's time to respond. It also has the potential to improve quality as it gives the therapist time to think through the most effective response and intervention. MBP will be based on CBT, PST or IPT intervention strategies.
15792505|NCT04512781|Device|Test Cannula #1|The purpose of this intervention is to evaluate the efficacy of a next generation cannula to provide relief of dyspnea.
15792472|NCT04513080|Behavioral|Message-based psychotherapy with monthly video chat (Premium Plan)|The Premium plan allows patients unlimited texting with their therapist and once a month, 30-45 minute video chat with the same therapist. Therapist and participants schedule their video chat appointment to occur at once a month interval during therapist office hours. The content of these sessions, as well as the MBP portion of care will be based on CBT, PST or IPT.
15792473|NCT04513080|Behavioral|Message-based psychotherapy with weekly video chat (Ultimate Plan)|The Ultimate Plan allows patients access to both unlimited MBP, but will be able to schedule weekly, 30-45 minute video chat with the same therapist. Therapists will provide care based on CBT, PST or IPT.
15792474|NCT04513067|Biological|YQ23|YQ23 as a single agent will be given in Stage 1.
15792475|NCT04513067|Combination Product|Pembrolizumab|Pembrolizumab will be given in combination with YQ23 in Stage 2
15792476|NCT04513054|Genetic|Blood collection for genetic analysis|Blood collection for genetic analysis
15792477|NCT04513041|Procedure|Pinhole surgical technique and tunnel technique in a split mouth design|Each subject will have the each surgical procedure which are both considered routine minimally invasive clinical care for gingival recession. Gum recession on one side will receive Pinhole surgical technique (test procedure). The other side will receive Tunnel technique (control procedure), Research component involved is the capture of digital impression using intra-oral scanner in the baseline (preoperative) and the final visit (6 months postoperative).
15792478|NCT04513028|Dietary Supplement|Beta-Glucan|500mg (1 capsule) by mouth twice a day for 21 days.
15792479|NCT04513015|Dietary Supplement|Antioxidant diet|"The antioxidant diet will include the principal antioxidant molecules/nutrients previously shown to be beneficial in IBD: Flavonoids, particularly resveratrol and curcumin; Olive oil; Glutathione, Vitamins A, C, E; Carotenoids; Selenium and Omega 3 Fatty Acids (PUFAs). The daily amount of these substances will be calculated following the published evidence, whether these amounts will not be achievable by a standard diet, a supplementary formulation will be proposed."
15792480|NCT04513015|Dietary Supplement|Normal dietetic scheme|Isocaloric, normolipidic diet for age and sex
15792481|NCT04513002|Dietary Supplement|Triheptanoin|Triheptanoin is a highly purified, synthetic medium odd-chain triglyceride that is catabolized to heptanoate.
15792482|NCT04512989|Diagnostic Test|Cognitive assesment using MOCA test|Cognitive assesment using MOCA test
15792483|NCT04512976|Other|Cooing Modalities|"Subjects will exercise for 60 minutes in the indicated environmental condition while being exposed to each of the following cooling modalities: no cooling, fan only, skin wetting only, and a combination of a fan and skin wetting.
~A fan will be a commercially available fan will be directed to the research subject throughout the exercise bout.
~Skin wetting will be performed by spraying water onto the well-healed grafted skin throughout the exercise bout.
~A combination of a fan and skin wetting will be performed by simultaneously applying both cooling modalities throughout the exercise bout."
15792484|NCT04512963|Drug|Progerinin|100 mg/g nano-suspension for oral use
15792485|NCT04512963|Drug|Placebo|A substance that has no therapeutic effect, used as a control in testing Progerinin
15792486|NCT04512950|Drug|Ringer's lactate|Half of the hospitals will be randomized to Ringer's Lactate for a 12 week study period; after a 2 week run-out, the study fluid will be switched to 0.9% saline for another 12 week study period, followed by a 2 week run-out.
15792487|NCT04512950|Drug|0.9% saline|Half of the hospitals will be randomized to 0.9% saline for a 12 week study period; after a 2 week run-out, the study fluid will be switched to Ringer's Lactate for another 12 week study period, followed by a 2 week run-out.
15792488|NCT04512937|Device|Computer-assisted navigation surgery|Computer navigation-assisted surgery has two main elements; the pre-procedural planning to create accurate 3D images of the pelvis allowing the surgical team to achieve an accurate perception of the operative field, and intraoperative navigation where these images are used for anatomical guidance to enhance surgical precision. Accordingly, computer software is used in this study to outline the tumour and other pelvic organs on pre-operative images which are subsequently used for intraoperative navigation.
15792489|NCT04512924|Behavioral|Enhanced mobile app with standard of care and education|Group 1 will download an enhanced mobile app that will include education and support resources related to food allergy and its management.
15792490|NCT04512924|Behavioral|Enhanced mobile app with standard of care, education and support resources|Group 2 will download an enhanced mobile app that will include education and support resources related to food allergy and its management, a symptom monitoring and tracking system that allows mobile app users to log symptoms they may experience as caregivers of children newly diagnosed with food allergy, e.g. fatigue and anxiety, and symptom based interventions (recommendations) that may improve a caregiver's ability to self-manage experienced symptoms.
15792491|NCT04512911|Procedure|Endocardial ablation|Endocardial ablation of VT
15792492|NCT04512911|Procedure|Endocardial- Epicardial ablation|Epicardial ablation of VT in addition to endocardial ablation
15792493|NCT04512911|Drug|Antiarrhythmic medications|Addition of anti arrhythmic medication or dose increase
15792494|NCT04512898|Drug|Triple therapy for H.pylori|Triple therapy of proton pump inhibitors, clarithromycin and metronidazole.
15792495|NCT04512885|Other|Survey|Survey via questionnaire
15792496|NCT04512872|Biological|CT-P41|60 mg/mL single dose, Solution for injection in PFS
15792497|NCT04512872|Biological|EU-approved Prolia|60 mg/mL single dose, Solution for injection in PFS
15792498|NCT04512859|Procedure|Stellate Ganglion Block|Stellate ganglion block under ultra-guide will be administered using 0.25% ropivacaine 10mL
15792499|NCT04512859|Procedure|Placebo|Stellate ganglion block under ultra-guide will be administered using 0.9% saline 10mL
15792500|NCT04512833|Radiation|Cyberknife stereotactic body radiation therapy|A total dose of 45-54 Gy in 5-10 fractions was given according to the location of lesions for small HCC patients with decompensated cirrhosis.
15792501|NCT04512820|Device|TRUCLEAR tissue removal system|evacuation of POC using the TRUCLEAR tissue removal system
15792502|NCT04512807|Diagnostic Test|AMH|AMH & PREGNANCY
15792503|NCT04512794|Device|AcQMap High Resolution Imaging and Mapping System|Evaluate the safety and effectiveness of the AcQMap System in mapping atrial arrhythmias when a specific procedure work flow is followed.
15792504|NCT04512781|Device|Control Cannula|The purpose of this intervention is to evaluate the efficacy of a conventional legacy cannula design to provide targeted relief of dyspnea.
15792506|NCT04512781|Device|Test Cannula #2|The purpose of this intervention is to evaluate the efficacy of a conventional legacy cannula design in providing targeted relief of dyspnea in hypercapnic adults.
15792507|NCT04512768|Behavioral|Transdiagnostic Internet-delivered Cognitive Behaviour Therapy|All participants receive an 8-week transdiagnostic course for anxiety and depression called The Wellbeing Course, originally developed by Macquarie University, Australia. The course is comprised of 5 lessons, beginning with psychoeducation and an introduction to the cognitive behavioural model, and then introducing key skills for managing anxiety and depression, including thought challenging, de-arousal strategies, graded exposure, behavioural activation, and relapse prevention. The course also includes supplementary resources that briefly provide information on related common concerns, such as managing worry, communication, assertiveness, problem solving, and a brief resource on sleep that provides limited psychoeducation and sleep hygiene information. Participants receive weekly brief therapist support via secure message or telephone from qualified counselors (social workers, psychologists).
15792508|NCT04512768|Behavioral|Brief Internet-Delivered Cognitive Behaviour Therapy for Insomnia|A new sleep lesson will replace the existing resource, developed using a patient-oriented process, that provides information and skills to aid with insomnia. The sleep lesson includes psychoeducation on the nature of sleep problems and factors that affect sleep, such as circadian rhythm. Two key behavioural strategies are introduced: sleep restriction, which requires the patient to avoid napping and sleep on a strict schedule for several weeks until they begin to feel naturally sleepy at night; and stimulus control, which asks the participant to only spend time in bed when prepared to sleep and avoid other activities (e.g., work, TV) in bed. Patients will record how much they sleep each night and provide ratings of sleep quality and fatigue each week. Therapists will support patients in adjusting their sleep schedule. Patients are encouraged to apply skills they learn during the Wellbeing Course to sleep problems, for example, by applying thought challenging to beliefs about sleep.
15792509|NCT04512742|Other|biting by Phlebotomus duboscqi infected with Leishmania major|The first six subjects will be exposed to biting by Phlebotomus duboscqi infected by Leishmania major and assess the 'take rate', that is the number of subjects developing parasitologically confirmed cutaneous leishmaniasis (PCCL) lesions. If 6/6 subjects develop PCCL lesions no further recruitment will take place; if only < 6 subjects develop PCCL lesions, then an adaptive design will be followed.
15792510|NCT04512729|Diagnostic Test|Colonoscopy|"For all patients, either moderate sedation with intravenous midazolam or conscious sedation with intravenous propofol will be administered in a standard fashion prior to undergoing colonoscopy.
~The colonoscope will be inserted and cecum will be intubated. Photo documentation of the cecum will be performed. The colonic mucosa will be carefully visualized upon withdrawal of the colonoscope.
~The time spent in inspecting the mucosa during withdrawal of the colonoscope will be documented as the withdrawal time. Meticulous technique will be employed during the withdrawal phase with special efforts to visualize portions of colonic mucosa on the proximal aspects of haustral folds, flexures and valves.All polyps detected will be documented: size, location, and morphology. Photo documentation of the polyps will be performed."
15792511|NCT04512716|Drug|131-I Apamistamab|Patients will receive 131-I apamistamab 75 mCi 5-7 days prior to a single infusion of 1x10^6 19-28z CAR T-cells/kg for those in the B-ALL cohort, or 2x10^6 19-28z CAR T-cells/kg, for those in the DLBCL. 131-I apamistamab may be administered inpatient or outpatient at the discretion and judgment of the treating investigators.
15792512|NCT04512716|Biological|CAR T-cell|19-28z CAR T-cells will be administered inpatient as a single infusion of 1x10^6 19-28z CAR T-cells/kg, for those in the B-ALL cohort, or 2x10^6 19-28z CAR T-cells/kg, for those in the DLBCL cohort. Patients will be observed inpatient for a minimum of 7 days (longer as clinically indicated and at the discretion of the treating physician).
15792513|NCT04512703|Device|µCor|Sensor Monitor for arrhythmia and other bio-metric markers
15792514|NCT04512690|Device|Epidural electrical stimulation (EES) of the cervical spinal cord|All participants enrolled in this group will undergo a surgical procedure to implant a system which provides epidural electrical stimulation (EES) of the cervical spinal cord. Researchers will quantify the ability of EES to recruit arm and hand muscles and produce distinct kinematic movements. The implant will be removed after less than 30 days.
15792515|NCT04512677|Device|Timed Inspiratory Effort (TIE index)|Conventional clinical treatment and using the Timed Inspiratory Effort (TIE index), which guided the decision to ventilate weaning and extubation.
15792516|NCT04512664|Other|cold application|cold application with gel pacs
15792517|NCT04512651|Other|Tibiotarsal Thrust Manipulation|The dancers were positioned in dorsal decubitus position with the heel outside the stretcher. The osteopath positioned in a lateral feint, inflected knees and forearms in the same plane as the participant's leg. With the internal hand slipped the pinky finger on the medial edge of the foot to the talus neck, the other fingers on the dorsum of the foot and the thumbs controlling the first metatarsus. The position of the talus in relation to the tibia was corrected, initially by placing the foot in eversion and then in dorsal flexion. The osteopath left the body weight behind, causing a traction in the joint. The thrust consisted of a impulse of high speed and low amplitude impulse in a caudal direction, closing the elbows20. The technique was performed until the obtainment (achieved) the joint noise only in the restricted foot, and only one service was performed. After one week, a reassessment of the painful sensation after the dance was performed.
15792518|NCT04512651|Other|Simulation Tibiotarsal Thrust Manipulation|Simulation of the technique Tibiotarsal Thrust Manipulation, with the participants and the osteopath positioned in the same way as the IG, however there was no reproduction of joint noise.
15792519|NCT04512638|Drug|Antibiotics|"Antibiotic treatment is the same in all groups.
~Monotherapy for 4 weeks with:
~No penicillin contra-indication
~Amoxicillin-clavulanate 875mg tid PO Penicillin contra-indication or intolerance
~Clindamycin 300mg tid PO
~After 4 weeks patients will be switched to consolidation antibiotics:
~No penicillin contra-indication
~Amoxicillin 1g bid PO Penicillin contra-indication or intolerance
~Clindamycin 300mg tid PO
~Antibiotic treatment can be discontinued after 4 weeks when the MRONJ lesions has healed."
15792520|NCT04512638|Drug|Chlorhexidine mouthwash|Patients in all treatment groups will be prescribed aqueous chlorhexidine 0.12% tid rinse for 2 weeks, with subsequent switch to 0.05% for the duration of the study or until healing of the MRONJ lesion has occurred.
15792521|NCT04512638|Procedure|Minimally invasive surgery with LPRF|Minimally-invasive surgical treatment, including sequestrectomy, debridement of soft tissue, and application of LPRF membranes before tension-free wound closure is obtained. Marginal resection of all necrotic bone is not part of this treatment strategy.
15792522|NCT04512638|Procedure|Surgical resection|Primary surgical management consisting of the removal of the necrotic bone without excessive resection of healthy bone. Buccal mucoperiosteal flaps will be used to achieve a tension-free mucosal coverage.
15792523|NCT04512625|Biological|Desensitizers|The main aims and objectives of the present study were to evaluate and compare the effectiveness of three commercially available desensitizing agents: Gluma (Hareus Kulzer), Sheildforce Plus (Tokuyama), and Telio CS (Ivoclar Vivadent) desensitizer in reducing the pre- and post-cementation sensitivity for full coverage restorations.
15792524|NCT04512612|Diagnostic Test|Chromoendoscopy|Participants randomised to Group A will undergo colonoscopic evaluation using dye-based chromoendoscopy
15792525|NCT04512612|Diagnostic Test|High definition white light colonoscopy|Participants randomised to Group B will undergo colonoscopic evaluation using high definition white light endoscopy
15792526|NCT04512599|Other|Prebiotic Bar|The prebiotic bar is a proprietary formula created by the study co-investigators, who will not be involved in participant recruitment, selection or outcome measures.The prebiotic bars will be shipped and stored at room temperature prior to consumption.
15792527|NCT04512586|Procedure|His-bundle pacing and AV node ablation|See study arm description.
15792528|NCT04512586|Procedure|Atrial fibrillation ablation by pulmonary vein isolation|See study arm description
15792529|NCT04512560|Behavioral|Surgical Training using Structured Remote Surgical Coaching in addition to Conventional Surgical Training|General surgery residents (PGY 1-5) will provide a video recording of a laparoscopic cholecystectomy that they performed as a primary surgeon. The coach will identify key moments or themes for discussion on how to improve technical skills and reduce intra-operative errors during five, 30-45 minute remote coaching sessions .
15792530|NCT04512560|Behavioral|Surgical Training using Conventional Training Program|General surgery residents (PGY 1-5) will continue their usual residency training.
15792531|NCT04512547|Drug|Hyperpolarized 129XeMRI|Images obtained using 129XeMRI will be obtained on both obese asthmatic and non-asthmatics
15792532|NCT04512534|Drug|PD-1 antibody+ HDAC inhibitor|"Patients receive anti-PD-1 antibody Sintilimab+ HDAC inhibitor Chidamide three weeks for a cycle, detailed as follows:
~Anti-PD-1 antibody (Sintilimab): Fixed dose of 200 mg every 3 weeks, intravenous drip (without pretreatment), infusion time: 30 minutes (no less than 20 mins, no more than 60 mins), the maximum treatment period is 2 years (up to 35 doses), complete remission（CR）patients confirmed by imaging assessment can be considered off anti-PD-1 treatment after 12 treatment cycles.
~Chidamide: Chidamide is administered orally at a dose of 30mg (initial dose). It is recommended to be administered within 0.5h after a meal with a fixed time. Chidamide will be given until disease progression or intolerant toxicity. The maximum treatment is 2 years. If chidamide therapy requires to be continued over 2 years due to clinical benefit, the prescription/decision should be made after discussion with the principal investigator."
15792533|NCT04512521|Drug|Mepolizumab|Mepolizumab therapy
15792534|NCT04512508|Diagnostic Test|Self test sample|Self test sample, DNA analysis, Biopsy and Anoscopy
15792535|NCT04512495|Other|Blood samples will be collected at two times :|"at Baseline,
~after surgery or at the time of post-chemotherapy evaluation."
15792536|NCT04512482|Drug|Bromelain|The subjects were randomized to either receive the bromelain pre-rinse or the powdered sugar placebo pre-rinse. Subjects then had a 5-9 day washout period and was then exposed to the other intervention.
15792537|NCT04512482|Other|Powdered sugar|The subjects were randomized to either receive the bromelain pre-rinse or the powdered sugar placebo pre-rinse. Subjects then had a 5-9 day washout period and was then exposed to the other intervention.
15792538|NCT04512469|Device|Low molecular weight mesh|Following liver implantation, the subcostal incision will be closed using a running fascial closure with absorbable 1-0 Polydioxanone (PDS) suture and staples, with the treatment group also receiving a mesh.
15792539|NCT04512456|Behavioral|Exercise training|Exercise training performed during 12 weeks, 3 sessions per week of 60 minutes of strength and aerobic exercises.
15792540|NCT04512443|Drug|Daflon|All consecutive patients were randomly allocated into 2 groups to receive Daflon (Detralex) at a dose of 1000 mg once daily (study group) or placebo (control group).
15792541|NCT04512430|Drug|Atezolizumab|"Patients will receive 1200 mg of Atezolizumab every 21 days (QW3) (+/- 3 days) during neoadjuvant phase and every 28 days (QW4) (+/- 3 days) at adjuvant phase in a monitored setting where there is immediate access to trained personnel and adequate equipment/medicine to manage potentially serious reactions.
~First Infusion
~No premedication administered for atezolizumab specifically is permitted
~Infuse atezolizumab (1200 mg in a 250 mL 0.9% NaCl IV bag) over 60 (+/- 15) minutes.
~Subsequent Infusions:
~If patient experienced infusion-related reaction during any previous infusion, premedication with antihistamines may be administered for Cycles > 2 at the discretion of the treating physician.
~If the patient tolerated the first infusion well without infusion-associated adverse events, the successive infusion may be delivered over 30 (+/- 10) minutes."
15792542|NCT04512430|Drug|Bevacizumab|Patients will receive 15mg/Kg of Avastin® (bevacizumab) administered by IV infusion every 21 days, for 3 cycles during neoadjuvant phase, in a monitored setting where there is immediate access to trained personnel and adequate equipment/medicine to manage potentially serious reactions.
15792543|NCT04512430|Drug|Carboplatin|"Structure: The cis-diamino (cyclobutan-1, 1 dicarboxilate) platin. Stability: 24 hours at ambient temperature in 5% glucose, glucosaline or physiologic saline. It is recommended not to dilute with chlorinated solutions since this could affect the carboplatin.
~Route of administration: Intravenous infusion Patients will receive Carboplatin AUC6 administered by IV infusion every 21 days, for 3 cycles during neoadjuvant phase.
~Guidelines of Carboplatin administration: According to the standard of each center"
15792544|NCT04512430|Drug|Pemetrexed|"Patients will receive Pemetrexed 500mg/m2 administered by IV infusion every 21 days, for 3 cycles during neoadjuvant phase.
~Pemetrexed disodium (ALIMTA®, pemetrexed) is a novel pyrrolo[2,3 d]pyrimidine-based folic acid analogue.
~Route of administration: Intravenous infusion. Guidelines of Pemetrexed administration: According to the standard of each center"
15792545|NCT04512417|Drug|Camrelizumab+Radiotherapy|The combined treatment group received radiotherapy for recurring or metastatic lesions: at least one or more lesions were irradiated, stereotactic body radiotherapy (SBRT, 8Gy/time, 3-5 times) or conventional radiotherapy (parts not suitable for SBRT, total Dose 30Gy or more); start immunotherapy within 8 weeks after radiotherapy.Until PD or toxicity is intolerable or up to 24 months.
15792546|NCT04512417|Drug|Camrelizumab|Camrelizumab,200mg,Q3W,Until PD or toxicity is intolerable or up to 24 months.
15792548|NCT04512391|Procedure|Ultrasound guided Erector Spinae Plane Block (ESPB)|Ultrasound guided ESPB is applied at T4 vertebrae level, 3 cm lateral to mid-line where transverse process lies. After identification of transverse process, needle is advanced in plane and real time visualisation on ultrasound screen. When bonny contact is encountered, normal saline is injected for verification of placement, then, 25 ml %0,25 bupivacaine is injected plane between transverse process and erector spinae muscles.
15792549|NCT04512378|Behavioral|Behavioural Experiments for Intolerance of Uncertainty|Cognitive-behavioural treatment targeting intolerance of uncertainty using behavioural experiment technique
15792550|NCT04512365|Drug|Placebo oral capsule|A capsule that contains only dextrose filler administered during the first or second laboratory visit.
15792551|NCT04512365|Drug|THC|A capsule that contains 7.5 mg of THC as well as dextrose filler administered during the first or second laboratory visit.
15792552|NCT04512352|Other|Online curriculum|"The psychologist and our advisory team had successfully developed a total of 100 hours of parenting curriculum.
~The adopted curriculum had focused on using play to facilitate parents in promoting their children's development in cognitive, motor, emotional and social aspects. Play-based activities are instrumental in improving children's development. Given that parents in poverty had difficulties spending time and money travelling back-and-forth to the training site and their homes, the research team decided to use e-learning as the medium of learning for our parenting programme. Web-based learning has the advantage of cutting time and travelling costs, which are luxuries to many parents in poverty."
15792553|NCT04512339|Drug|Dupilumab|Dupilumab injections (blinded labels)
15792554|NCT04512339|Drug|Placebo|Placebo injections (blinded labels), matching the dupilumab injections in quantity and appearance
15792555|NCT04512326|Procedure|Total or Subtotal colectomy|Total or subtotal colectomy (emergent or elective) with primary anastomosis (ileorectal or ileosigmoid)
15792556|NCT04512313|Drug|Rocuronium 0,3mg/kg|Rocuronium 0,3mg/kg at induction
15792557|NCT04512313|Drug|Rocuronium 0,9mg/kg|Rocuronium 0,9mg/kg at induction
15792558|NCT04512287|Drug|Autologous Platelet Rich Plasma|2 sessions of Autologous PRP will be administered 15 days apart. Each injection will be 0.5 mL of PRP injected into the Peyronie's disease penile plaque.
15792559|NCT04512287|Other|Saline Solution|2 sessions of saline injection will be administered 15 days apart. Each injection will be 0.5 mL of normal saline injected into the Peyronie's disease penile plaque.
15792560|NCT04512274|Device|Test Article|Omeza Collagen Matrix
15792561|NCT04512261|Drug|Tucatinib|Initial dosage of trial treatment for tucatinib will be given as 300 mg (dispensed as 2 x 150 mg tablets) orally twice a day for Days 1 - 21 of each 3-week cycle during the treatment period.
15792562|NCT04512261|Drug|Pembrolizumab|Initial dosage of trial treatment for pembrolizumab will be given as 200 mg by intravenous infusion every 3 weeks on Day 1 of each 3-week cycle during the treatment period. Pembrolizumab will be administered for a maximum of 35 doses.
15792563|NCT04512261|Drug|Trastuzumab|Initial dosage of trial treatment for trastuzumab will be given as 8 mg/kg by intravenous (IV) infusion once on Day 1 of Cycle 1, and 6 mg/kg by IV every 3 weeks on Day 1 of each 3-week cycle starting on Cycle 2 during the treatment period.
15792564|NCT04512248|Behavioral|Quit and Stay Quit Monday Model|Participants randomized to the study intervention will receive: (1) 2 telephone smoking cessation coaching calls; (2) enrollment into SmokefreeTXT; and (3) enrollment in the iquitmonday.org weekly email newsletter. The telephone coaches will ask these participants to identify a future Monday as their quit date and provide coaching to achieve a Monday quit. The coaches will also enter the selected Monday as the patient's quit day when enrolling the patient into SmokefreeTXT.
15792565|NCT04512235|Drug|CAEL-101|The investigational product, CAEL-101, is formulated as a sterile liquid solution of protein plus excipients for dilution in a single-use, stoppered, glass vial. Each 10 mL vial contains 300 mg of CAEL-101 at a concentration of 30 mg/mL. CAEL-101 will be diluted with commercially available 0.9% Normal Saline.
15792566|NCT04512235|Other|Placebo|Commercially available 0.9% Normal Saline will be used as the placebo.
15792567|NCT04512235|Drug|cyclophosphamide, bortezomib, and dexamethasone (CyBorD) regimen|According to institutional standard of care.
15792568|NCT04512209|Procedure|MRI|"Patients will undergo an MR scan before undergoing cytoreductive surgery. If neoadjuvant chemotherapy is administered, an extra MR scan is planned before the start of the neoadjuvant chemotherapy.
~During surgery, tissue samples will be taken for interstitial fluid pressure (IFP) measurement, immunohistochemistry (IHC) and characterization of biophysical properties (viscoelastic properties and hydraulic conductivity)."
15792569|NCT04512196|Drug|Superoxidized Water|Super-oxidized solution contains hypochlorous acid (HOCl) which exhibits bactericidal activity. These reactive species create an imbalanced osmotic gradient which damages the cell membrane integrity of single celled organisms, and subsequently denaturing its lipid and protein content. Multicellular organisms including host tissue are not susceptible to such changes in osmolarity hence spared from damage.
15792570|NCT04512196|Drug|Normal Saline|Normal saline contains 0.9% sodium chloride.
15792571|NCT04512183|Other|High-Fidelity Simulation|Teaching strategy based on high-fidelity simulation, which simulates the reality of health care to promote meaningful learning.
15792572|NCT04512183|Other|Low-Fidelity Simulation|Teaching strategy based on low-fidelity simulation, which simulates the reality of health care using less technological and less interactive mannequins.
15792573|NCT04512170|Drug|HEC585|single or Mulltiple doses up to 10 days
15792574|NCT04512170|Drug|placebo|single or Mulltiple doses up to 10 days
15792575|NCT04512157|Behavioral|Promoting Alternative Thinking Strategies (PATHS), Preschool Edition|PATHS® is a universal teacher implemented, and school-based intervention that aims to give preschool children a strategically timed boost in social emotional competence. Specifically, PATHS® encourages the use of interactive techniques to bolster children's ability to self-regulate, increase their adeptness at social cognitive problem solving, as well as to gain insight into their emotions and emotions of others.
15792576|NCT04512144|Behavioral|Headspace Smartphone Application|Headspace is a smartphone application used for mindfulness, meditation, and stress reduction. It has been utilized in other behavioral and quality of life studies.
15792577|NCT04512131|Procedure|dialysis mode|intermittent hemodialysis or continuous renal replacement therapy
15792578|NCT04512118|Diagnostic Test|PET-CT of 18F-FDG|Whole-body 18F-FDG-PET/CT was performed on a digital hybrid system (Vereos, Philips®)
15792581|NCT04512092|Behavioral|Compassionate Mind Training for Caregivers|CMT-C is a 12-session group program, each lasting about 2,5 hours, which run on a weekly basis. The program is organized across 3 modules: 1) Our mind according to a compassion-based approach (to provide insight into the evolved and socially shaped mind and the affect regulation systems); 2) Compassionate mind training (understanding and cultivating the attributes and competencies of compassion in its three flows, and addressing its fears); and 3) final session (revising key information and practices and its application to the RCH practices/routines). Its sessions have the following structure: 1) Check-in (grounding exercise, reviewing the previous session, sharing the weekly practice); 2) Exploration of the session theme (psychoeducation and experiential practices followed by group opportunities for share experiences and discussion); 3) Check-out (session summary and application to the self, youths and RCH practices, weekly practice challenge, session evaluation, session take-off).
15792582|NCT04512079|Drug|Enoxaparin|Prophylactic enoxaparin (40 mg SC QD; 30 mg SC QD for CrCl <30 mL/min) Full-dose enoxaparin (1 mg/kg SC Q12h; 1 mg/kg SC QD for CrCl <30 mL/min)
15792583|NCT04512079|Drug|Apixaban|(5 mg Q12h; 2.5 mg Q12h for patients with at least two of three of age ≥80 years, weight ≤60 kg or serum creatinine ≥1.5 mg/dL)
15792587|NCT04512053|Drug|TAS-303 18 mg/day|Oral administration for 12 weeks, once daily
15792588|NCT04512053|Drug|Placebo|Oral administration for 12 weeks, once daily
15792589|NCT04512040|Behavioral|At-Home Yoga|At-home yoga practice over 12 weeks.
15792590|NCT04512027|Other|Prolectin-M; a (1-6)-alpha-D-Mannopyranose class|A treatment to decrease viral load, detected through digital droplet PCR, in mild to moderate cases of RT-PCR positive COVID-19
15792591|NCT04512027|Other|Standard of Care|Currently approved standard of care for patients without symptoms requiring hospitalisation will be provided to all.
15792592|NCT04512014|Diagnostic Test|serum lactate|perioperative measurement of lactate levels
15792593|NCT04512001|Drug|MSB11456|Participants will receive MSB11456 subcutaneously, once a week.
15792594|NCT04512001|Drug|EU-approved RoActemra|Participants will receive EU-approved RoActemra® subcutaneously, once a week.
15792595|NCT04511988|Other|Diagnostic Test|blood sample (20 ml) and biopsy
15792596|NCT04511975|Drug|IBI188|IBI188: 100 mg/mL, intravenous infusion once a week
15792597|NCT04511975|Drug|Azacitidine|Azacitidine (VIDAZA) for Injection:100 mg per vial, subcutaneous injection will be administered for 7 days in each 28 day cycle
15792598|NCT04511962|Other|Tele-Pulmonary rehabilitation|The tele-rehabilitation programme will be delivered via an NHSX / NHS Digital approved commercial video conferencing application. It will comprise an initial assessment followed by 12 bespoke classes delivered by video link over a 6 week period. Participants will be advised to undertake exercises on 5 days each week.
15792599|NCT04511949|Diagnostic Test|COVID-19 IgG / IgM rapid test (whole blood, serum, plasma)|"The rapid test is performed using a drop of blood obtained at the fingertip (10 microliters) using a lancet.
~The dropper pipette, held vertically, collects the drop of whole blood up to the sample line
~Place 1 drop of whole blood (10 μL in the sample well (S) of the cassette.
~Immediately add 2 drops (80μL) of buffer to the well (B) of the cassette.
~Avoid air bubbles; if there is an air bubble, add a 3rd drop of buffer.
~The reading is taken after 10 minutes at most by the healthcare professional under medical supervision.
~In case of sepositivity of the rapid test, it may be offered to index cases and adult contacts, a blood sample of 5 ml of blood for a serothèque allowing a characterization of the antibodies and in particular of the neutralizing antibodies."
15792600|NCT04511936|Device|i-Lumen AMD|Microcurrent stimulator
15792601|NCT04511936|Device|i-Lumen AMD Sham|Sham microcurrent stimulator
15792602|NCT04511923|Drug|Nebulised heparin|Nebulised unfractionated heparin 25000 units administered 6 hourly for 10 days
15792603|NCT04511910|Procedure|Early Laparoscopic Cholecystectomy|
15792604|NCT04511897|Drug|An'ningpai|An'ningpai Enteric Soft Capsules was a kind of expectorant, comprised with Eucalyptol, Limonene and Pinene. 300 mg, oral, three times daily for 12 months.
15792605|NCT04511884|Diagnostic Test|Next-generation sequencing|The patient who may be diagnosed with cryptogenic organizing pneumonia will be detected through next-generation sequencing.
15792607|NCT04511858|Other|maximum effort test on a cycloergometer|5 h test on cycloergometer
15792608|NCT04511858|Other|maximum effort test on a treadmill|5 h test on treadmill
15792609|NCT04511845|Drug|SPYK04|SPYK04 capsule
15792610|NCT04511832|Drug|Diclofenac|Patients who were diagnosed as breast cancer and met the inclusion criteria will be recruited and randomly assigned to acupuncture group or drug (NSAIDs) group. After each subgroup completing the 4 weeks intervention, all the participants were enter washout period lasting 2 weeks to eliminate the effect of the previous treatment. Crossover was held after washout period and made the patients to have the other treatment in the following 4 weeks. After receiving the case, the third group recorded the pain indicators for the first month, followed by a one-month trial- combination of acupuncture and NSAID treatment, and then followed up for another month after stopping.
15792611|NCT04511819|Drug|Losmapimod oral tablet|This study includes a 14-day treatment period. Patients will receive losmapimod 15 mg twice daily given as two 7.5 mg tablets per dose by mouth: for a total of 4 pills or 30 mg daily. The study drug should be taken with food when possible.
15792612|NCT04511819|Drug|Placebo oral tablet|This study includes a 14-day treatment period. Patients will receive Placebo twice daily given as two tablets per dose by mouth: for a total of 4 tablets daily. The study drug should be taken with food when possible.
15792613|NCT04511806|Other|Registry|This prospective registry and biorepository will collect clinical data and specimens for research in childhood cancer predisposition.
15792614|NCT04511793|Device|Medtronic Synchromed II pump|The pump will be placed during surgery and the pump will be filled with a combination of floxuridine (FUDR), dexamethasone, heparin, and saline.
15792617|NCT04511754|Behavioral|Experiential Psychotherapy Skill Training|The Experiential Training intervention will include components of training not usually included in standard clinical training experiences; such components include opportunities for deliberate practice of the skills trained, live supervision and feedback, and discussion with a trainer focused on the skills taught and the trainees' performance.
15792618|NCT04511754|Behavioral|Standard Psychotherapy Skill Training|Standard didactic training with research support, examples, and opportunities to ask questions.
15792619|NCT04511741|Other|no intervention, it is an observational study.|no intervention, it is an observational study.
15792620|NCT04511728|Drug|HSK3486|The initial Induction dose of HSK3486 is 0.4 mg/kg. The initial maintenance dose of HSK3486 is 0.8 mg/kg/h
15792621|NCT04511728|Drug|Propofol|The initial Induction dose of propofol is 2.0 mg/kg. The initial maintenance dose of propofol is 5.0 mg/kg/h
15792622|NCT04511715|Drug|Intravitreal Bevacizumab IVB|Intravitreal Bevacizumab IVB group (50 eyes) that receive 6 bimonthly IVBs within a period of 10 months following the enrollment
15792623|NCT04511715|Other|Follow-up with regular examination for determination of DR progression|regular examination for determination of DR progression
15792624|NCT04511702|Biological|Pegloticase with MTX|Participants will receive MTX during the run-in period then pegloticase with MTX for up to 24 weeks during the treatment period
15792625|NCT04511689|Device|gene-activated bone substitute mixed with autobone|gene-activated bone substitute based on octacalcium phosphate and plasmid DNA encoding VEGFA gene mixed with autobone
15792626|NCT04511663|Combination Product|Assertive community treatment|The intervention team consisted of psychiatrists, nurses, clinical psychologists, social workers, rehabilitation teachers. The specific services provided by the team include individual service plan. Each patient got a comprehensive evaluation within one month to establish treatment goals and individual intervention plan, rehabilitation training, family intervention peer support group, individual psychological counseling and crisis intervention.
15792627|NCT04511663|Combination Product|Basic public health services.|The control group received regular medical follow-up including symptom and medication evaluation, social function evaluation and physical examination after hospital discharge. The frequency was once a quarter.
15792628|NCT04511650|Drug|Razuprotafib Subcutaneous Solution|Up to 3 daily dose levels of Razuprotafib Subcutaneous Solution will be evaluated. Doses will be administered subcutaneously three times daily (Q8H) for 7 days.
15792629|NCT04511650|Drug|Placebo Subcutaneous Solution|Matched vehicle-controlled placebo solution will be administered subcutaneously three times daily (Q8H) for 7 days
15792630|NCT04511637|Drug|Rivaroxaban (BAY 59-7939, Xarelto) in ODT form|15 mg as 1 x 15 mg orally disintegrating tablet (ODT)
15792631|NCT04511637|Drug|Rivaroxaban (BAY 59-7939, Xarelto) in film-coated form|15 mg as 1 x 15 mg film-coated tablet
15792632|NCT04511624|Drug|IBI112 dose1|Drug: IBI112 SC dose1 Drug:placebo
15792633|NCT04511624|Drug|IBI112 dose2|Drug: IBI112 SC dose2 Drug:placebo
15792634|NCT04511624|Drug|IBI112 dose3|Drug: IBI112 SC dose3 Drug:placebo
15792635|NCT04511624|Drug|IBI112 dose4|Drug: IBI112 SC dose4 Drug:placebo
15792636|NCT04511624|Drug|IBI112 dose5|Drug: IBI112 IV dose5 Drug:placebo
15792637|NCT04511624|Drug|IBI112 dose6|Drug: IBI112 SC dose6 Drug:placebo
15792638|NCT04511624|Drug|IBI112 dose7|Drug: IBI112 IV dose7 Drug:placebo
15792639|NCT04511611|Drug|Rivaroxaban (BAY 59-7939, Xarelto) in ODT form|10 mg as 1 x 10 mg orally disintegrating tablet (ODT)
15792640|NCT04511611|Drug|Rivaroxaban (BAY 59-7939, Xarelto) in film-coated form|10 mg as 1 x 10 mg film-coated tablet
15792641|NCT04511598|Device|"Bellus 3D Face Camera"|The depth sensor uses infrared structured light scanning technology to capture depth and the camera on the phone or tablet to capture color texture of the face.
15792642|NCT04511598|Device|"Planmeca ProMax 3D Proface"|The lasers scan the facial geometry and the digital cameras capture the color texture of the face.
15792643|NCT04511585|Behavioral|Great Live and Move Challenge|Physical activity program for children
15792644|NCT04511572|Procedure|embolization of the middle meningeal artery|The embolization procedure will be as follows: first femoral artery access will be obtained by using a 5 French micropuncture kit and common carotid and external carotid angiography is performed using a standard 5 French diagnostic catheter. A microcatheter is then advanced selectively under roadmap guidance into the middle meningeal artery (MMA), and MMA angiography is performed to evaluate for potential dangerous anastomoses such as the orbital branch to the ophthalmic artery. Embolization is performed using polyvinyl alcohol particles (100 microns in diameter) under blank fluoroscopic roadmap while carefully avoiding reflux. Particles are infused until lack of anterograde flow into the MMA branches is demonstrated on angiography, and the catheters are removed [31]. The procedure is performed under local anesthesia.
15792645|NCT04511559|Diagnostic Test|Circulating Tumor DNA Methylation Sequencing|Whole blood collection through venipuncture. DNA methylation levels by deep sequencing.
15792646|NCT04511559|Diagnostic Test|tissue DNA Methylation Sequencing|Isolate DNA from tissue samples from subjects. DNA methylation levels by deep sequencing.
15792647|NCT04511546|Device|BPET Prototype Scan|Scan on the BPET Prototype PET system and qualitative comparison with a PET image acquired on a conventional clinical PET system.
15792648|NCT04511533|Drug|Dacomitinib|Dacomitinib is a kinase inhibitor indicated for the first line treatment of patients with metastatic NSCLC with EGFR exon 19 deletion or exon 21 L858R substitution mutations.
15792649|NCT04511520|Other|Physical training program|
15792650|NCT04511520|Drug|Trimetazidine|
15792651|NCT04511507|Procedure|hemoadsorption|three consecutive sessions of hemoadsorption in patients with liver failure
15792652|NCT04511494|Dietary Supplement|Peanut (bamba)|OIT peanut with slow-updosing for 40-60 weeks followed by maintenance. 3 years treatment.
15792653|NCT04511481|Other|Radiomic Algorithm|Different radiomic and machine learning strategies for radiomic features extraction, sorting features and model constriction
15792654|NCT04511468|Dietary Supplement|Zinc, Chromium, Vitamin C, and Copper Supplementation|Combination of mineral and vitamin supplementation that consist of Zinc, Chromium, Vitamin C, and Copper
15792655|NCT04511468|Behavioral|Standard healthy lifestyle intervention|Standard healthy lifestyle intervention will follow the Guidelines on the Management and Prevention of Prediabetes by the Indonesian Ministry of Healthy and the Indonesian Diabetes Association.
15792658|NCT04511442|Other|Evaluation of food preferences during a standardized and validated buffet.|"The dietary preferences of people will be collected by a direct measurement of eating behavior in front of a dedicated and standardized ad-libitum buffet.
~As part of this buffet, 3 dichotomous categories of food will be studied:
~high / low in fat (HF / LF)
~high / low in carbohydrates (HC / LC)
~high / low in protein (HP / LP). During the buffet, participants will be filmed to study their food choices and the microstructure of their meal. We will define food preferences as the relative consumption choices of the food categories studied. We will also collect the time spent at the buffet, the duration of ingestion, the total duration of the meal, the number of bites per minute, the total number of bites and the number of bites by type of food.
~Weighing's will be carried out before and after consumption in order to determine the total energy intake and the macronutrient intake (proteins, lipids, carbohydrates) of the participants."
15792659|NCT04511416|Drug|Metformin XR, 500-2000mg nocte|anti diabetic medication
15792660|NCT04511390|Device|Transparent, reusable respirator|A novel respirator with dual N95 filter cartridges
15792661|NCT04511377|Device|Rehabilitation using Digital Healthcare System (Uincare Homeplus)|"Uincare Homeplus is a device using infrared, kinect camera and motion capture technology to track 3D motion of the patients' posture and joint articulations. It also has embedded exercise training software dedicated to rotator cuff repair post-op rehabilitation at home.
~Home-based self-rehabilitation using brochure for 6 weeks post surgery (same as the active comparator)
~Home-based self-rehabilitation using digital healthcare system(Uincare Homeplus) for 6 to 12 weeks post surgery."
15792662|NCT04511377|Other|Conventional Rehabilitation|Home-based self-rehabilitation using brochure for 12 weeks post surgery.
15792663|NCT04511364|Other|Clinical imaging is performed during the 24 and 60 month follow-up visits|X-ray and DXA scan
15792664|NCT04511351|Drug|Chidamide|chidamide administration during radiation and chemotherapy phase in the study group
15792665|NCT04511338|Device|Dialyzer with Endexo|"Sequence AB:
~Period 1 Circuit A (Five Visits: 1,2,3,4,5) Period 2 Circuit B (Five Visits: 9,10,11,12,13)
~Sequence BA:
~Period 1 Circuit B (Five Visits: 1,2,3,4,5) Period 2 Circuit A (Five Visits: 9,10,11,12,13)"
15792666|NCT04511325|Other|Potato Regimen|100 grams cooked white russet potato with the skin
15792667|NCT04511325|Other|Refined Grain Regimen|75 grams of cooked long-grain white rice
15792668|NCT04511299|Other|SMOFlipid 20%|Fish oil-enriched intravenous lipid emulsion
15792669|NCT04511299|Other|Lipofundin 20%|MCT/LCT standard intravenous lipid emulsion
15792670|NCT04511286|Behavioral|Exposure|Systematic confrontation with stimuli associated with symptom-related distress, to achieve therapeutic changes in cognitions or behavior
15792671|NCT04511273|Drug|Follow up of female sexual function|Mirabegron 50mg once daily for treatment of overactive bladder symptoms
15792672|NCT04511260|Device|NuEra Tight VRF Handpiece|"The VRF is a Model that belongs to the NuEra Tight RF Family, specific for the treatment of small areas.
~The NuEra is FDA cleared (K151296) for a wide range of indications including but not limited to, selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The NuEra Tight VRF with the small area handpiece is CE marked in Europe and currently under review by the FDA. The system and its accessories, are intended to be use for a wide range of indications including, but not limited to:
~· Provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation of soft tissue."
15792673|NCT04511247|Device|MagicTouch PTA Sirolimus drug coated balloon|For participants randomised to MagicTouch PTA sirolimus DCB, following successful plain balloon angioplasty of the arterial lesion (defined as <30% residual stenosis after treatment at rated burst pressure of the angioplasty balloon), MagicTouch sirolimus coated balloon will be applied at the lesion after appropriate sizing using the diameter of the plain balloon angioplasty.
15792674|NCT04511247|Device|POBA balloon|For participants randomised to the standard balloon angioplasty group, a placebo standard balloon which is identical to the SCB will also be applied at the lesion after appropriate sizing using the diameter of the plain balloon angioplasty
15792675|NCT04511234|Device|MagicTouch PTA sirolimus drug coated balloon (DCB)|For participants randomised to MagicTouch PTA sirolimus DCB, following successful plain balloon angioplasty of the arterial lesion, (defined as <30% residual stenosis after treatment at rated burst pressure of the angioplasty balloon), MagicTouch PTA sirolimus coated balloon will be applied at the lesion after appropriate sizing using the diameter of the plain balloon angioplasty.
15792676|NCT04511234|Device|POBA standard balloon|For participants randomised to the standard balloon angioplasty group, a placebo standard balloon which is identical to the SCB will also be applied at the lesion after appropriate sizing using the diameter of the plain balloon angioplasty.
15792677|NCT04511221|Dietary Supplement|Bifidobacterium animals subsp. lactis BL04+PreforPro|One 15mg capsule taken orally each day
15792678|NCT04511221|Dietary Supplement|Bifidobacterium animals subsp. lactis BL04|One 15mg capsule taken orally each day
15792679|NCT04511221|Other|Placebo|One 15mg capsule taken orally each day
15792682|NCT04511195|Dietary Supplement|Standardized extract of Sphaeralcea angustifolia|Each patient will be treated topically with a gel containing the Sphaeralcea angustifolia extract three times a day for 4 weeks. Sphaeralcea angustifolia extract is standardized in its active compounds content: Sphaeralcic acid and scopoletin
15792683|NCT04511195|Drug|Diclofenac Sodium Gel|Each patient will be treated topically with a gel containing 2% diclofenac three times a day for 4 weeks.
15792719|NCT04510909|Other|COMMIT mHealth application|The investigators will develop Community-based mHealth Motivational Interviewing Tool (COMMIT) using iterative design and testing with frequent, structured input from the key stakeholders: community health workers (CHWs), their supervisors and adult depression patients.The tool will be used by community CHWs in Dolakha, Nepal to: 1) obtain decision-support to deliver motivational interviewing (MI) for patients in their communities, and 2) capture consented audio recordings of client interactions for review and feedback by their supervisors, allowing CHWs to maintain MI skills beyond the initial training period.
15792782|NCT04510337|Drug|Magnesium sulfate|50 mg/kg magnesium sulphate added to 0.40 mg/kg rocuronium
15792684|NCT04511182|Behavioral|Exercise-based cardiac rehabilitation|"Exercise program is based on aerobic exercise and supplemented by strength training following the principle of gradual improvement. The type of exercise, such as walking, jogging, cycling, and the intensity of exercise which is recommended to use a cardiotach or pedometer to detect, are both defined by the results of CPET, such as METs value. Participators must be prepared for about 5-10 minutes to warm up and recover before and after exercise. 30-50 minutes a day, 5 days a week, with a total exercise time of not less than 150 minutes per week. It can be carried out in different stages according to the physical condition. After 1-3 months, the exercise prescription will be re-adjusted according to the results of reexamination.
~All patients will undergo Cardiopulmonary Exercise Test, SF-36, echocardiography and laboratory examination prior to initiation of the trial, and which will be checked again after 3 months, and 6 months."
15792685|NCT04511169|Behavioral|digital self-help|The digital self-help program is targeting every-day ADHD symptoms in adults with a diagnosed ADHD
15792686|NCT04511156|Other|Foundational Helping Skills|Each site will implement three waves of Foundational Helping Skills training. Each training will include 12 trainees each, with a minimum of 2 trainers per training. Each site will include pre and post research days, where they will collect primary and secondary outcomes with support from research staff (trained raters, actors, and qualitative researcher). Each site will qualitatively assess the training after the first wave to identify any areas for modification, and after the second and third waves to develop recommendations for future implementation.
15792687|NCT04511143|Other|muscle strength and ultrasound imaging measurement|hamstring muscle strenght measured by hand held dynamometer. The long head of Biceps Femoris, Semitendinosus, Semimembronosus were evaluated by B-mode ultrasound imaging.
15792689|NCT04511117|Other|Control group|ProTaper Next rotary system and iRoot SP sealer with composite restorations.
15792690|NCT04511117|Other|Endocrown group|ProTaper Next rotary system and iRoot SP sealer with endocrown restorations.
15792691|NCT04511104|Other|Exercise|Resistance and aerobic exercise in addition to standard of care rehabilitation
15792692|NCT04511104|Other|Standard of Care|Standard of care rehabilitation
15792693|NCT04511091|Procedure|VATS lobectomy|VATS lobectomy allows surgeons to carry out exactly the same operation within the chest that is performed by thoracotomy, but it is done through 3-4 small incisions without rib spreading rather than the large incision with rib spreading that a thoracotomy entails. The surgeon gains his view inside the chest from a small video camera inserted through one of the small incisions, and the procedure is carried out with long instruments passed through the other small incisions.
15792694|NCT04511078|Drug|Panitumumab-IRDye800|single dose infusion of panitumumab-IRDye800CW
15792695|NCT04511065|Other|Newsletter using a virtual mode of delivery|Newsletter creation where topics in the newsletter are chosen by participants in the intervention group.
15792699|NCT04511039|Drug|Trifluridine and Tipiracil Hydrochloride|Given PO
15792700|NCT04511039|Drug|Talazoparib Tosylate|Given PO
15792701|NCT04511026|Drug|Lymphoseek|Radioactive diagnostic agent
15792702|NCT04511026|Device|Single Photon Emission Computed Tomography (SPECT)|Imaging test
15792703|NCT04511026|Drug|Indocyanine Green (ICG)|Cyanine dye used in medical diagnostics manufactured by Akorn Inc.
15792704|NCT04511026|Device|Neoprobe Gamma Detection System NPB11L(Model1102)|Neoprobe Gamma Detection System NPB11L(Model1102) made by Devicor Medical Products, Inc.
15792705|NCT04511013|Drug|Binimetinib|Given PO
15792706|NCT04511013|Drug|Encorafenib|Given PO
15792707|NCT04511013|Biological|Ipilimumab|Given IV
15792708|NCT04511013|Biological|Nivolumab|Given IV
15792709|NCT04511000|Drug|Lipilou®(generic atorvastatin drug) 20 mg|Patients assigned to experimental group are treated with Lipilou® 20 mg
15792710|NCT04511000|Drug|Lipilou®(generic atorvastatin drug) 10 mg|Patients assigned to comparator group are treated with Lipilou® 10 mg
15792711|NCT04510987|Drug|BAY2433334 single dose in treatment groups 1-4 and 6 as well as on the dialysis free day of treatment 5|Tablet, oral
15792712|NCT04510987|Other|BAY2433334 on dialysis treatment day|Tablet, oral
15792713|NCT04510974|Other|Spinal Cord Injury|Spinal Cord Injury
15792714|NCT04510961|Other|Paraffin baths therapy|Patients in treatment group will receive paraffin wax baths for five days per week for 12 weeks. Prepare the paraffin device and blocks of paraffin wax. Put the paraffin wax blocks inside the tank and set the thermostat 35 to 40◦C. Melting paraffin was taken from 90 to 120 minutes. Adjust the suitable temperature for each patient before immersion of patient's hand. Submerge patient's hand completely for three to four seconds then withdraw it
15792715|NCT04510948|Behavioral|Patient Priorities Care|"Patient Priorities Care (PPC) is an innovative approach to shared decision-making that draws from existing professional training.
~PPC requires the elicitation and documentation of patient health outcome goals and care preferences and the alignment of clinical care with health goals and healthcare preferences. This information will be collected and documented in the EHR by facilitators and shared with the clinicians who will then use the PPC approach with patients to inform and guide treatment decisions.
~The PCPs will be trained in decisional strategies that have been shown to help align care with patients' health priorities. While encouraged to use these decisional strategies, PCPs will be free to make the recommendations they feel most appropriate for each patient.
~This intervention has been developed to be integrated seamlessly into usual care."
15792716|NCT04510935|Procedure|general anesthesia|the patient will receive general anesthesia during surgery in this group.
15792717|NCT04510935|Procedure|local anesthesia|the patient will receive local anesthesia during surgery in this group.
15792718|NCT04510922|Drug|Droxidopa 100 MG [Northera]|droxidopa taken three times a day titrated up to a maximum of 600 mg.
15792720|NCT04510896|Other|InheRET|Primary Appropriate Referral Rates 6-months pre-intervention vs post-intervention Compare appropriate genetic counseling referral rates (as defined by NCCN guidelines) per patient (across all sites) in the pre-intervention vs post- intervention period. Only referrals to Michigan Medicine genetics clinics will be included in the statistical analysis. Having access to MM health records, we will be able to assess the appropriateness of the referrals.
15792721|NCT04510896|Other|Patient Acceptance|Acceptance by Patients Over the course of the study Acceptance measures will include completion rates and levels of ease of use of InheRET by the patient. Impact measures will include uptake of advised risk management interventions. We will qualitatively describe why patients do not follow up with their referral. We will explore patterns of acceptance and impact levels by demographic and clinical data using correlation, t- tests, ANOVA, or their non-parametric equivalents.
15792722|NCT04510896|Other|Physician Acceptance Survey|Secondary Acceptance by Physicians Over the course of the study Acceptance by physicians will measure the physician effort required to deploy and use InheRET in their respective clinics, and overall satisfaction. Impact measures will include appropriate referral rates and rates of genetic testing. We will qualitatively describe why patients are not referred for genetic counseling if indicated. We will explore patterns in acceptance and impact levels by demographic and clinical data using correlations, t-tests, ANOVA, or their non-parametric equivalents.
15792723|NCT04510883|Behavioral|PACO|The intervention is a fully-automated web-based eHealth application in which two embodied conversational agents engage in dialogue with older adults in order to motivate them towards dietary behavior change and decrease loneliness. The application consists of five different modules, each one applying different behavior change techniques.
15792724|NCT04510883|Behavioral|Waiting list + PACO|Waiting list + PACO
15792725|NCT04510870|Drug|Ferric Carboxymaltose Injection|Infusion prior the start of IVF/ICSI cycle. Dosing according to the summary of product characteristics (SmPC) chart. Placebo infusion before frozen embryo transfer if needed.
15792726|NCT04510870|Drug|NaCl infusion|Placebo infusion prior the start of IVF/ICSI cycle. Ferric Carboxymaltose infusion before frozen embryo transfer if needed. Dosing according to the summary of product characteristics (SmPC) chart.
15792727|NCT04510844|Drug|Evolocumab|Evolocumab is commercially available in the United States and is manufactured by Amgen. Drug and placebo, will be supplied by the manufacturer. The SureClick® pre-filled auto injector contain Evolocumab (140 mg) acetate (1.2 mg), polysorbate 80 (0.1 mg), proline (25 mg) in water for Injection. Evolocumab will be administered at a dose of 420 mg subcutaneously once monthly.
15792728|NCT04510844|Other|Placebo|Placebo will be supplied by the manufacturer. Placebo auto injectors will be identically packaged but will lack the active ingredient. Placebo will be administered at an equivalent volume to Evolocumab and given subcutaneously once monthly.
15792729|NCT04510831|Other|Refined maize with extrinsic addition of labelled FeSO4|Porridge prepared with refined maize flour with extrinsic addition of FeSO4 (isotopic iron 54)
15792730|NCT04510831|Other|T.molitor native chitin|Porridge prepared with dried intrinsically labelled T.molitor (isotopic iron 57) native chitin, refined maize flour and extrinsic addition FeSO4 (isotopic iron 58)
15792731|NCT04510831|Other|T molitor reduced chitin|Porridge prepared with dried intrinsically labelled T.molitor (isotopic iron 57) reduced chitin, refined maize flour and extrinsic addition FeSO4 (isotopic iron 58)
15792732|NCT04510818|Drug|Capecitabine, Camrelizumab|This is a single-arm study with all patients receiving these two drugs.
15792733|NCT04510805|Device|NextDose (nextdose.org)|"NextDose guided warfarin management taking into consideration covariates (sex, age, weight, height CYP2C9 (rs1057910) and VKORC1 (rs9923231), the dosing and INR history of each patient to predict an individualized dose in accordance with the theory-based warfarin model and target concentration intervention principles.
~Initial recommended warfarin dose, up to the first INR, will be the maintenance dose predicted from group values, subsequently the NextDose predicted maintenance dose will be recommended. The treating clinician will also be provided with the NextDose report to inform the choice of the prescribed dose."
15792734|NCT04510792|Other|No intervention|No intervention
15792735|NCT04510779|Device|Apple Watch|Apple Watch is a smartwatch developed by Apple Inc. The heart rate variability function will be used.
15792736|NCT04510753|Device|Arterial catheterization kit|Invasive monitoring of blood pressure via catheterization of the radial artery, displaying a continuous pressure waveform and blood pressure values.
15792737|NCT04510753|Device|GE Datex-Ohmeda Finger Clip Pulse Oximeter Sensor|PPG fingertip mounted sensor, that measures the oxygen level (oxygen saturation) of the blood and generates a waveform
15792738|NCT04510753|Device|NIBP Cuff (GE Healthcare)|A blood pressure cuff is used to measure blood pressure. The cuff has an inflatable rubber bladder that is typically fastened around the arm. A pressure meter indicates the cuff's pressure.
15792739|NCT04510740|Other|Physician's choice according to patient's needs.|Routine care as per site standard.
15792740|NCT04510727|Device|Optical Coherence Tomography (OCT)|VivoSight Dx OCT system from Michelson Diagnostics Ltd. OCT will be used to visualize the tumor and lesion in the skin.
15792741|NCT04510727|Procedure|Curettage & Desiccation (C&D) Procedure|Standard of care C&D where the basal cell carcinoma lesion will be scraped to its base using a Fox dermal curette and an electrodesiccation machine.
15792742|NCT04510714|Device|Image guided percutaneous microwave ablation|Lung metastasis from sarcoma will be treated with microwave antennas (SOLERO) and Ablation System and microwave generators (Angiodynamics), with power settings of 35-45W and an average ablation time of 15 minutes (range 10-30 minutes). The ablation time will be recorded for all procedures. The manufacturer's recommendations will be observed in all cases, since it is assured that patients are able to tolerate the total ablation time.
15792744|NCT04510688|Drug|Cabozantinib|Observation of treatment with Cabozantinib
15792745|NCT04510675|Device|Test Article|Omeza Collagen Matrix
15792746|NCT04510675|Device|Negative Control|Occlusive Patch of 0.9% sodium chloride, NaCl
15792747|NCT04510662|Drug|Telmisartan|Patients in this group will receive telmisartan 40 mg daily plus standard care.
15792748|NCT04510649|Drug|Part A|in Part A, all subjects will receive Surufatinib 300 mg in a single dose on study days 1 and 11 and receive Rabeprazole 30 mg single dose on study days 5 through 11
15792749|NCT04510649|Drug|Part B|in Part B, all subjects will receive Surufatinib 300 mg in a single dose on study days 1 and 12 and receive Rifampin 600 mg single dose on study days 5 through 16
15792750|NCT04510636|Drug|Pembrolizumab|Pembrolizumab is a intravenously administered humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
15792751|NCT04510636|Drug|Bendamustine Hydrochloride|Bendamustine is a unique alkylating agent with substantial activity in hematologic malignancies.
15792752|NCT04510623|Other|ARBs and/or ACE inhibitors|This is an observational study only.
15792753|NCT04510623|Other|Usual Care|This is an observational study only.
15792754|NCT04510610|Drug|Camrelizumab and Decitabine|Decitabine is an investigational (experimental) drug that works by depleting DNA methyltransferase 1 (DNMT1), which can increase tumor antigens and HLA expression, enhances antigen processing, promotes T cell infiltration, and boosts effector T cell function. Camrelizumab is a humanized anti-PD-1 monoclonal antibody.
15792755|NCT04510597|Procedure|Cytoreductive Nephrectomy|Radical or partial nephrectomy may be performed using laparoscopic, open, or robotic approaches. Surgery should be performed within 8 weeks of randomization
15792756|NCT04510597|Drug|Active Comparator|"Nivolumab 240 mg IV 1 q 2 weeks
~OR
~Nivolumab 480 mg IV 1 q 4 weeks
~OR
~Pembrolizumab 200 mg IV 1 q 3 weeks Axitinib 5 mg oral Daily BID
~OR
~Avelumab 10 mg/kg IV 1 q 2 weeks Axitinib 5 mg oral Daily BID"
15792759|NCT04510571|Other|Evaluating Postoperative Pain After Root Canal Treatment with Protaper Next|Patients were randomly separated into two groups and root canal treatments were completed with Protaper Next file systems. Instrumentation time for each system was noted and patients were given a pain scale which included visual analog scale for 6, 24, 48 and 72 hours after treatment.Postoperative pain scores and instrumentation times were analyzed statistically with chi square test and student t test.
15792760|NCT04510571|Other|Evaluating Postoperative Pain After Root Canal Treatment with Reciproc Blue Files|Patients were randomly separated into two groups and root canal treatments were completed with Reciproc Blue file systems. Instrumentation time for each system was noted and patients were given a pain scale which included visual analog scale for 6, 24, 48 and 72 hours after treatment.Postoperative pain scores and instrumentation times were analyzed statistically with chi square test and student t test.
15792761|NCT04510558|Device|Stoma closure with non-resorbable mesh (ULTRAPRO Advanced Mesh, Ethicon, Johnson & Johnson) in the sublay position|"Antibioprophylaxis using cefuroxime and metronidazole
~Standard disinfection and sterile draping
~Circular incision around the stoma using the scalpel blade
~Dissection around the stoma until entering the abdominal cavity
~Closure of the stoma using a linear stapler
~A midline laparotomy may be performed or not
~Realization of an extra-corporeal or intra-corporeal side-to-side handsewn anastomosis
~Closure of the posterior aponeurosis using separate Maxon 2-0 stitches
~Application of an ULTRAPRO Advanced Mesh, Ethicon, Johnson & Johnson, with +2cm on the edges, secured by 4 stiches of Maxon 2-0
~Closure of the anterior aponeurosis using separate Maxon 2-0 stitches
~No subcutaneous stitches
~Partial purse string skin closure using Monocryl 3-0
~Standard wound dressing"
15792762|NCT04510558|Procedure|Stoma closure without mesh|"Antibioprophylaxis using cefuroxime and metronidazole
~Standard disinfection and sterile draping
~Circular incision around the stoma using the scalpel blade
~Dissection around the stoma until entering the abdominal cavity
~Closure of the stoma using a linear stapler
~A midline laparotomy may be performed or not
~Realization of an extra-corporeal or intra-corporeal side-to-side handsewn anastomosis
~Closure of the posterior aponeurosis using separate Maxon 2-0 stitches
~Closure of the anterior aponeurosis using separate Maxon 2-0 stitches
~No subcutaneous stitches
~Partial purse string skin closure using Monocryl 3-0
~Standard wound dressing"
15792763|NCT04510545|Diagnostic Test|Endobrain, Computer Aided Diagnosis (CAD)|Artificial intelligence
15792764|NCT04510532|Diagnostic Test|CMR examination|After recruiting participants and collecting the baseline information, a CMR scan and a post-processed imaging procedure will be carried on .And the follow-up is planned at 1,6 months after chemotherapy in order to detect the cardiac impairment
15792765|NCT04510506|Device|Artificial Pancreas (AP)|The AP system used in this trial is the Tandem t:slim insulin pump with Control-IQ Technology. This system is FDA approved for use starting at age 14 years.
15792766|NCT04510493|Drug|Canakinumab|Body weight adjusted dose in 250 ml 5% dextrose solution i.v. over 2 hours
15792767|NCT04510493|Drug|Placebo|Aqua ad injectabilia in 250 ml 5% dextrose solution i.v. over 2 hours
15792768|NCT04510480|Other|Observational study without specific intervention|Observational study with standard cardiac arrest approach
15792769|NCT04510454|Diagnostic Test|Nasopharyngeal and throat/oropharyngeal swabs analyses by RT-PCR and ddPCR|Nasopharyngeal and throat/oropharyngeal swabs analyzed by both RT-PCR and ddPCR
15792770|NCT04510441|Other|Nil intervention|Nil intervention; retrospective cohort study
15792771|NCT04510428|Drug|Ocular Surface Immune Globulin (OSIG)|Ocular Surface Immune Globulin (OSIG) eye drops 4 mg/ml (0.4%) four times a day for 8 weeks
15792772|NCT04510428|Drug|Placebo|Normal Saline Eye Drops (0.9% NaCl) four times a day for 8 weeks
15792773|NCT04510415|Drug|Olmutinib|"600 mg QD continuously in 21-day cycles until disease progression determined by investigator assessment per RECIST version 1.1, and as long as, in the investigators opinion, they are benefiting from study treatment and they do not meet any of treatment discontinuation criteria."
15792774|NCT04510402|Drug|Povidine iodine nasal swabs|Daily versus twice daily nasal application
15792775|NCT04510389|Dietary Supplement|Maltodextrin|Bariatric patients with or without sarcopenia receiving maltodextrin
15792776|NCT04510389|Dietary Supplement|Whey|Bariatric patients with or without sarcopenia receiving whey protein
15792777|NCT04510376|Device|Test Article|Omeza Collagen Matrix
15792778|NCT04510376|Other|Positive Control|1.0 mg/mL Histamine Base
15792779|NCT04510376|Other|Negative Control|Aqueous Negative Control
15792783|NCT04510324|Other|Red meat patties group|"Baseline Visit: day -7 before randomization
~Clinical history and physical exam
~Refrain from seafood, eggs, fish or meat, for 7-day (washout) prior to Day 1.
~Day 1 Randomization
~Randomization to 1 of 2 interventions: plant-based or meat burgers
~6 days-worth of burgers will be delivered to the participant's house
~Day 1-6:
~• The participant will be asked to eat a specific randomized diet for 6 days
~Days 6
~Physical exam (weight, BP, HR)
~Blood draw: Circulating TMAO
~Days 7
~Physical exam (weight, BP, HR)
~Food questionnaire
~Blood draw: Circulating TMAO, Total, LDL, and HDL cholesterol, Creatinine, High-sensitivity c-reactive protein
~Urine Collection - TMAO
~Day 7-14: Washout
~Day 14: Patties delivery
~Day 14-20: Assigned diet for 6 days
~Days 20: Same as day 6
~Days 21: Same as day 7"
15792784|NCT04510324|Other|Plant-based patties group|Same as above
15792785|NCT04510311|Drug|3-[18F]Fluoro-para-hydroxyphenethylguanidine|Single IV injection of 12.0 mCi (+/- 10%) [18F]3F-PHPG
15792786|NCT04510311|Drug|[123I] metaiodobenzylguanidine|Single IV injection of 10.0 mCi [123I]MIBG
15792787|NCT04510311|Diagnostic Test|Positron emission tomography/computed tomography scan|Whole-body PET/CT scan performed at two time-points: 1.5 hours and 3 hours after IV injection of [18F]3F-PHPG
15792788|NCT04510311|Diagnostic Test|Planar scintigraphy scan|Whole-body scan using planar scintigraphy with a gamma camera performed the day after IV injection of [123I]MIBG
15792789|NCT04510311|Diagnostic Test|Single photon emission computed tomography/computed tomography scan|SPECT/CT scan of the primary neuroendocrine tumor performed the day after IV injection of [123I]MIBG
15792790|NCT04510298|Drug|SP-624|Oral Capsule
15792791|NCT04510298|Drug|Placebo|Oral Capsule
15792792|NCT04510285|Drug|Trastuzumab|Trastuzumab (8mg/kg loading dose; 6mg/kg maintenance) will be administered on day 1 of each 3-week dosing cycle (21 days).
15792793|NCT04510285|Drug|Pembrolizumab|Pembrolizumab 200 mg IV will be administered on day 1 of each 3-week dosing cycle (21 days).
15792794|NCT04510272|Other|Aloud Real-time Reading of ICU Diaries|Standard ICU diaries will be read aloud in real time daily to patients by ICU nurses/therapists/family members
15792795|NCT04510259|Procedure|Selective Brachial plexus Block|It is one type of peripheral nerve blocks for upper extremity surgery. In this study, the block will be done under the ultrasound guidance and the local anesthetic agent (a mixture of 2% Xylocaine with 1: 200,000 adrenaline and 0.5% Chirocaine in a total of 25ml) will be injected at the trunks of the brachial plexus in order to produce the surgical anesthesia of the whole upper extremity of the patients scheduled for upper limb surgeries.
15792796|NCT04510246|Behavioral|Enhanced case management|"The health care worker will offer support to the GP for all aspects of the cascade of hepatitis C care including:
~Further testing advice
~Awareness that treatment can be prescribed by the general practitioner
~Conducting pre-treatment work-up assessment
~DAA prescription guidelines, including linkage to specialist consultation
~Providing treatment support
~Advising on testing process for cure
~Advising on post-cure management including methods of follow-up to manage risks (e.g. harm minimisation, reducing re-infection risk, opioid substitution therapy)
~Linking GP to resources for patients with cirrhosis or other concerns to specialist support for ongoing management.
~The GP will be offered the option of the DoH specialist to contact the patient directly with the GP's consent to notify them of their result and to educate them on testing and treatment options and referral back to their GP."
15792797|NCT04510233|Drug|Ivermectin nasal|Ivermectin nasal spray one ml in each nostril two times daily
15792798|NCT04510233|Drug|Ivermectin oral|Ivermectin oral (one tablet 6 mg three times daily)
15792799|NCT04510233|Other|standard care|oxygen via masks or ventilators
15792800|NCT04510220|Drug|Ofatumumab|Ofatumumab (OMB157) is a fully human anti-CD20 monoclonal antibody (mAb) self-administered by a once-monthly subcutaneous injection that is in development for MS. Ofatumumab drug product (also referred as OMB157) is formulated as 20 mg/0.4 mL (50 mg/mL) solution for injection, provided in autoinjectors, for subcutaneous administration. The autoinjectors contain a small overfill to allow for a complete withdrawal of the labeled amount (20 mg) of ofatumumab.
15792801|NCT04510220|Drug|[F-18]PBR06|PET radiopharmaceutical. Subjects will undergo [F-18]PBR06-PET (microglial activation).
15792802|NCT04510207|Biological|Inactivated SARS-CoV-2 Vaccine (Vero cell)|The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP
15792803|NCT04510207|Biological|Inactivated SARS-CoV-2 Vaccine (Vero cell)|The inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by BIBP
15792804|NCT04510207|Biological|Placebo|The placebo of inactivated SARS-CoV-2 Vaccine (Vero cell) manufactured by WIBP
15792805|NCT04510194|Drug|Metformin|Metformin; immediate release formation; 1,500mg daily for 14 days
15792806|NCT04510194|Drug|Placebo|placebo; appearance and size-matched to study drug
15792807|NCT04510194|Drug|Fluvoxamine|An antidepressant, administered in twice-daily dosing, 50 mg twice per day for 14 days
15792808|NCT04510194|Drug|Ivermectin|An antiparasitic medication administered as 390mcg/kg for weight category <104 kg, and 470mcg/kg for weight category >104 kg for 3 days
15792809|NCT04510181|Dietary Supplement|amino acid-based blend|blended (listed in descending order) L-lysine, L-arginine, oxo-proline, N-acetyl-l-cysteine, L-glutamine, and Schizonepeta tenuifolia
15792810|NCT04510168|Drug|11C-ER176|PET imaging to measure 18kDa translocator protein; target imaging dose of up to 20 millicurie (mCi)
15792811|NCT04510168|Drug|[F-18]MK-6240|PET imaging to measure tau; target imaging dose of 4 to 5 mCi
15792812|NCT04510168|Drug|Florbetaben|PET radioligand that binds to amyloid plaques; target-imaging dose of up to 8.1 mCi
15792813|NCT04510168|Other|Magnetic Resonance Imaging|Brain MRI
15792814|NCT04510155|Behavioral|Overnight fasting duration|Subjects will adhere to overnight fasting protocol for 1 day
15792815|NCT04510129|Diagnostic Test|OncoPrism™ assay|OncoPrism™ is a new approach to characterizing the immune component of pre-treatment tumor tissue.
15792816|NCT04510116|Behavioral|Adults in the Making program|The AIM prevention program, modeled after an existing family-based skills-training intervention in a group format for rural African American preadolescents, consists of six consecutive weekly group meetings held at community facilities, with separate parent and youth skill-building curricula and a family curriculum. Each of the six meetings includes separate, concurrent training sessions for parents and youth, followed by a joint parent-youth session during which the families practice the skills they learned in their separate sessions. Concurrent and family sessions each last 1 hour. Thus, both parents and youth receive 12 hours of prevention training.
15792817|NCT04510103|Drug|Moisturizer A, F#9155-005|OTC Monograph Drug. Used twice daily on left or right lower leg per randomization schedule.
15792818|NCT04510103|Other|Moisturizer B, F#E1387-004|Cosmetic Moisturizer. Used twice daily on left or right lower leg per randomization schedule.
15792819|NCT04510103|Procedure|Regression|2 week regression period after 6 weeks of moisturizer use.
15792820|NCT04510103|Procedure|Non-Regression|Physical insult (tape stripping) on the lower leg after 6 weeks of moisturizer use.
15792821|NCT04510090|Drug|EP547|EP547
15792822|NCT04510090|Drug|Placebo|Placebo
15792823|NCT04510077|Behavioral|SmartQuit Smoking and Tobacco Cessation Program|Use SmartQuit program
15792824|NCT04510077|Other|Survey Administration|Ancillary studies
15792825|NCT04510064|Drug|Camrelizumab plus mFLOT regimen|Patients were treated with domestic PD-1 antibody (Camrelizumab for injection) commbined with mFLOT regimen immunotherapy every three weeks, and HER-2 positive patients were added with Herceptin therapy. Camrelizumab 200mg on day 1, albumin bound paclitaxol 125mg/m² on day 1,oxaliplatin 85 mg/m² on day 1, leucovorin 200 mg/m² on day 1, and 5-FU 2600 mg/m² as 24-h infusion on day 1.Herceptin 6mg/Kg at the first time, followed by 4mg/Kg if needed.
15792826|NCT04510064|Procedure|R0 surgery|The efficacy of therapy was evaluated every 3 treatment cycles. If the tumor can be R0 resected after 6-9 cycles, then proceeded to surgery. After the operation, patients continued to receive the prior immunotherapy totally to 12 cycles or to the disease progressed or intolerable toxicity.
15792827|NCT04510051|Drug|Cyclophosphamide|Given IV
15792828|NCT04510051|Drug|Fludarabine|Given IV
15792829|NCT04510051|Biological|IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes|Given intraventricularly
15792830|NCT04510038|Drug|Colchicine|"Colchicine dosing = 0.6 mg bid x 30 days Decrease dose to 0.3-0.6 mg daily or every other day in setting of gastrointestinal intolerance (nausea, diarrhea, emesis, abdominal discomfort) Decrease dose to 0.6 mg daily in the setting of weak or moderate CYP3A4 inhibitor Decrease dose to 0.3 mg daily in the setting of strong CYP3A4, P-glycoprotein inhibitors, or protease inhibitors Decrease dose to 0.3 mg daily in the setting of CKD stage ≥ 4 (CrCl ≤ 30 ml/min) or liver failure (AST/ALT > 3x normal).
~Decrease dose to 0.6 mg every 14 days in patients with end stage renal disease (ESRD) or requiring dialysis Route of Administration: oral"
15792831|NCT04510038|Other|Covid-19 Standard of Care|As per treating physician
15792832|NCT04510025|Diagnostic Test|Magnetic Resonance Imaging|We will undertake multi-organ MRI to assess the health of vital organs including the brain, heart, lung, kidneys and liver. We will additionally examine the burden of ongoing respiratory limitations, mental health problems and quality of life in survivors of COVID-19 at 3, 6 and 12 months.
15792833|NCT04510012|Other|Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage.|Analysis of cytokine response, innate and adaptive immune response, complement activation, and serum neurofilaments as a marker of neurological damage.
15792834|NCT04509999|Drug|Bicalutamide 150 Mg Oral Tablet|Bicalutamide 150 mg by mouth daily
15792835|NCT04509999|Drug|Placebo|Placebo as formulated by mouth daily
15792836|NCT04509973|Drug|Dexamethasone|ATC code: H02AB02
15792837|NCT04509960|Device|direct laryngoskopy|Proseal Laryngeal mask inserted with direct laryngoskopy
15792840|NCT04509934|Other|Connective Tissue Manipulation|The position of the patients during treatment sessions was sitting with the hips and knees at 90° flexion and feet supported, arms relaxed on the thighs, back naked and straight, allowing optimal tension of the connective tissue. The CTM procedure consisted of treating 3 sections in the back. These sections were basic (sacral and lumbar regions), lower thoracic (L1 through T7) and anterior pelvic. All sessions were ended with bilateral long strokes to the iliac crest and subcostal regions. The physiotherapist applied strokes bilaterally by her middle finger of the right or left hand to the defined zones of the mentioned sections in the back. The treatment started from the basic section, and progress to other regions was decided according to the vascular reaction of the connective tissue. Each session lasted for 5 to 20 minutes, depending on the extent of the treated area.
15792841|NCT04509921|Other|asthma treatment adjustment taking account on degree of bronchial hyperresponsiveness|Modification of inhaled corticosteroid dose based on the symptoms and the result of bronchial provocation (BHR group)
15792842|NCT04509895|Procedure|Lateral extensile approach in calcaneal fractures fixation|The standard extended lateral approach with L-shaped incision was made in this group, which originated vertically from 5 cm over lateral malleolus or the midpoint between the fibula and Achilles tendon and ended on the base of the fifth metatarsal . The incision is made directly to the bone at the corner to create a full-thickness flap. Attention must be paid to protect the sural nerve and peroneal tendons as well.
15792843|NCT04509895|Procedure|Minimally invasive sinus tarsi approach in calcaneal fractures fixation|An incision is made from the tip of the lateral malleolus toward the base of the fourth metatarsal bone. The incision lies in a plane between the superficial peroneal nerve and the sural nerve. Care is taken to bluntly dissect after the skin incision to protect the sural nerve or branches of the superficial peroneal nerve. By mobilizing the sinus tarsi fat pad dorsally, the incision was deepened. The extensor digitorum brevis muscle is sharply elevated off of the anterior process with the lateral root of the inferior extensor retinaculum and reflected dorsally and distally. The peroneus brevis and peroneus longus tendons are split, allowing exposure to the sinus tarsi and visualization of the posterior facet of the subtalar joint.
15792844|NCT04509882|Drug|bear bile pill|Bear bile pill (15 pills) taken orally three times a day after meals with water.
15792845|NCT04509882|Drug|placebo|Placebo(15 pills) taken orally three times a day after meals with water.
15792846|NCT04509869|Procedure|varicocelectomy|operation for varix ligation
15792847|NCT04509856|Behavioral|Teach-back educational method|In the teach-back method, after teaching new information to the patient, the patients were asked to explain that new information in their own words. Then the patients' knowledge and the adequateness of their explanations were determined. The patient should repeat the instructions in their own words. In this way, the healthcare professional can evaluate how the patient understands the information. If the patient repeated the information correctly, the teach-back phase for that information was completed, and progression for new information was resumed. However, if there was a deficiency or error in the information, it was corrected and repeated by the healthcare professional.
15792848|NCT04509843|Behavioral|socioeconomic status|it is a cross-sectional study for assessment the impact of socioeconomic status on periodontal health through using a definite scale mentioned in the protocol related to the middle east people.
15792849|NCT04509830|Other|hip strengthening|resistance training for hip abductor, hip extensor, and hip external rotator
15792850|NCT04509830|Other|quadriceps strengthening, stretch hamstring,cuff muscles|multi-angle isometric quadriceps strengthening and hamstring and cuff self stretch
15792851|NCT04509817|Device|Acupuncture+Usual care|"Acupuncture intervention Disposable, sterilized needles (0.25×40 mm and 0.30×50 mm) will be used and selected acupoints will include GV20, CV4, and bilateral BL32, ST25, ST29, EX-CA1, LI4, LR3, SP6, SP9. Subject will be prone position first and BL32 will be inserted with an angle of 30-45° in an inferomedial direction and a depth of 30-50 mm. Once the subject has a needle sensation ('De-qi'), the needle will be removed immediately. Then the subject will be supine position, and GV20, CV4, ST25, ST29, EX-CA1, LI4, LR3, SP6, SP9 will be needled with a depth of 10-40mm. After subject feel 'De-qi', the needles will be placed for 20 min to maintain the stimulation.
~Usual care intervention The subjects will receive the health advice including diet with regular meal, enough sleep, and appropriate exercise.
~Behavioral: Usual care Usual care intervention The subjects will receive the health advice including diet with regular meal, enough sleep, and appropriate exercise."
15792852|NCT04509817|Behavioral|Usual care|Usual care intervention The subjects will receive the health advice
15792853|NCT04509804|Other|non-interventional|non-interventional
15792854|NCT04509791|Drug|Anti-Human Thymocyte Immunoglobulin, Rabbit|MELD - ATG : Minimum effective low dose ant-human thymocyte globulin (rabbit)
15792855|NCT04509778|Other|routine clinical treatment|Participants will be informed that this is not a treatment study and it involves naturalistic follow-up without any extra intervention. They will otherwise follow the routine clinical treatment procedure.
15792856|NCT04509765|Radiation|Linac Based VMAT TBI|Use of linac based Volumetric Arc Therapy (VMAT) to deliver Total Body Irradiation (TBI). The study intervention is a VMAT based delivery technique using a 6 MV photon beam from a Varian TrueBeam® (Palo Alto, CA) equipped with a Millennium multi-leaf collimation (MLC) system3. TBI will be delivered using a Varian TrueBeam linear accelerator with photon beam VMAT capability. VMAT is a radiation technique combining dynamic photon fluence modulation using multi-leaf collimation (MLC) with gantry rotation to deliver a highly conformal dose distribution with improved target coverage and sparing of organs at risk (OARs).
15792857|NCT04509752|Other|Survey|An online survey will be sent to each clinic to answer the survey questions.
15792858|NCT04509739|Behavioral|Music intervention|"At 9 months of age, families will start the 12 - session intervention in a controlled laboratory space. In the initial session, caregivers will be given a brief orientation to intervention, including introducing them to the musical toys they will be using during the sessions with their infants and the lab environment. They will also be trained techniques through which they can synchronize the infant's movements to the experimenter's movements, such as clapping hand, tapping feet.
~The remaining sessions will be scheduled in groups of 2-3 infant/parent dyads. In each session, a music CD with 15 minutes of selected children's music will be played and a musically trained experimenter will facilitate the sessions to engage the infants and parents to move to musical beats, using different musical toys, such as infant drums and maracas. Parents will be instructed to not to repeat any of these activities outside of the lab setting for the period of the study."
15792859|NCT04509726|Drug|LMBP2-specific TCR-T cell with IL12 auto-secreting element|Patients were pre-conditioned with chemotherapy and infused with LBMP2-specific TCR-T cells with IL12 auto-secreting element
15792860|NCT04509713|Behavioral|Collection of odour samples|Samples of breath odours will be passively collected while participants wear the mask while breathing naturally, for at least 3 h. Skin odours will be passively collected by participants wearing the shirt and nylon socks for at least 12 h.
15792861|NCT04509700|Drug|Parsaclisib|Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib as that provided in the parent Protocol at the time of the rollover.
15792862|NCT04509700|Drug|parsaclisib + itacitinib|Participants will continue on the same dose (1,2.5,5 OR 20 mg) and schedule of parsaclisib and 100 mg of itacitinib as that provided in the parent Protocol at the time of the rollover.
15792865|NCT04509661|Drug|LABA/LAMA or Placebo inhalation|Inhaled LABA/LAMA for one year.
15792866|NCT04509648|Radiation|External Beam radiotherapy using IMRT technique|2600cGy/ 5 fractions / 1 weeks to ipsilateral chest wall or whole breast and regional lymph regions and a sequential tumor bed boost of 5.2 Gy in 2 fractions to the conserved breast
15792867|NCT04509635|Drug|Cetuximab|Cetuximab is used for only patients with ctDNA test RAS wild type.
15792868|NCT04509635|Drug|Chemotherapy|The detailed regimen is determined by a multi-disciplinary team according to the previous use of chemotherapy.
15792869|NCT04509622|Drug|Venetoclax|Tablet; Oral
15792870|NCT04509622|Drug|Cytarabine|Subcutaneous Injection
15792871|NCT04509609|Other|Exon 3 truncating mutation|Any patient affected by LGMD 2E with a genetic diagnosis carrying the truncating mutation c.377_384duplCAGTAGGA on exon 3, both in homozygosis and in heterozygosis
15792872|NCT04509609|Other|Any other mutation in SGBC gene|Any patient affected by LGMD 2E with a genetic diagnosis other than the truncating mutation c.377_384duplCAGTAGGA on exon 3, both in homozygosis and in heterozygosis
15792895|NCT04509414|Drug|Dexmedetomidine|For dexmedetomidine group after ramdomization, an intranasal dose of 2ug/kg dexmedetomidine will be administrated.
15792896|NCT04509414|Drug|Midazolam|For midazolam group after ramdomization, an intranasal dose of 0.2mg/kg midazolam will be administrated.
15793781|NCT04502316|Device|BAROSTIM NEO™ System|Implantation of the BAROSTIM NEO™ System
15792873|NCT04509596|Drug|DZD1516 mono therapy in Part A, DZD1516 in combination with trastuzumab and/or capecitabine in Part B, DZD1516 in combination with T-DM1 in Part C|"Part A is twice daily (except Cycle 0) oral dosing of DZD1516, starting from 50 mg. If tolerated, dose will be escalated in subsequent cohorts until MTD.
~Part B is twice daily oral dosing of DZD1516 in combination with capecitabine 1000 mg/m2 orally twice daily on Days 1-14 of each 21-day cycle or with trastuzumab 8 mg/kg intravenously (IV) on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of each 21-day cycle.
~Part C is twice daily oral dosing of DZD1516 in combination with T-DM1 3.6 mg/kg intravenously (IV) once every 21 days"
15792874|NCT04509583|Dietary Supplement|PROFortil|Multi-micronutrient supplement (PROfortil™, twice daily) plus Vitamin E (Enat 400, once per day) in 3 months
15792875|NCT04509583|Other|Vitamin E|Only Vitamin E (Enat 400, once per day) in 3 months
15792876|NCT04509570|Procedure|Biopsy|5~20mg/ml, intralesional injection every 1 month. Number of cycles: until the lesions are clinically cleared
15792877|NCT04509557|Drug|[177Lu]Ludotadipep|Dose is sequentially elevated starting from a low dose to a high dose (50±5 mCi, 75±8 mCi, 100±10 mCi, 125±13 mCi, 150±15 mCi). If DLT is observed in 2 or less of 6 subjects at each level, advance to the next step. If DLT is observed in 3 or more participants, no further subject will participate in the study at the relevant dose. Appropriateness of the dose elevation is evaluated 8-9 weeks after drug administration.
15792878|NCT04509531|Behavioral|Wise Intervention (SA, ITP and resilience)|The intervention will be based on four general types of change strategies: (1) scientific knowledge, (2) generation of new meanings, (3) commitment through action, and (4) active reflection. This will include activities such as reading scientific information about social behavior and its role in people's well-being and mental health, the meaning of online victimization experiences and ways to react to them, experiences of other young people of their age, and self-persuasion exercises that involve an active commitment to change. Furthermore, it provides a number of strategies to manage everyday conflicts among adolescents. This intervention teaches them new ways to manage these difficulties through different actions (relaxation, distraction, sports, etc.). Finally, they are asked to plan the strategies they will use in the future in the face of some difficulties and to recommend some guidelines for another adolescent who may be going through a similar situation.
15792879|NCT04509531|Behavioral|Standard preventive intervention|The control intervention will involve scientific information and education about internet risks such as sexting and grooming.
15792880|NCT04509518|Other|Exercise therapy program plus TENS therapy|All patients were receiving the same physical therapy exercise program, 3 times per week for 12 weeks in the form of pelvic floor relaxation exercises, diastasis correction exercises , myofascial trigger points release, connective tissue manipulation and progressive abdominal strengthening exercises. Pelvic floor relaxation exercises included pelvic floor release stretches, Proprioceptive Neuromuscular Facilitation technique, and pelvic floor drop exercises in addition to TENS therapy The standard protocol for TENS therapy in this group was 20 minutes of 100 Hz frequency, pulse duration of 200 µsec, three times a week for successive 12 weeks
15792881|NCT04509492|Diagnostic Test|Endoscopic ultrasound ( EUS )|"- EUS will be done to all patients. During EUS examination the liver will be examined thoroughly to detect hepatic focal lesions with possible EUS-FNA of any detected lesions.
~All EUS examination will being done by EUS linear array Echoendoscope, Pentax EG-3870UTK attached to Hitachi Avius US machine under Propofol deep sedation"
15792882|NCT04509479|Procedure|Valve replacement|Description of valve replacements
15792883|NCT04509466|Drug|Part 1: Liposomal mitoxantrone hydrochloride and Pegaspargase|"Drug: Liposomal mitoxantrone hydrochloride (12mg/m2, 16mg/m2, 20mg/m2, 24mg/m2) is administered by an intravenous infusion (IV) on day 1 of each 21-day cycle.
~Drug: Pegaspargase (2000IU/m2) is administered by an intramuscular injection (IM) on day 1 of each 21-day cycle."
15792884|NCT04509466|Drug|Part 2 (treatment-naïve patients): Liposomal mitoxantrone hydrochloride and Pegaspargase|"Drug: Liposomal mitoxantrone hydrochloride (RP2D defined in Part 1) is administered by an intravenous infusion (IV) on day 1 of each 21-day cycle.
~Drug: Pegaspargase (2000IU/m2) is administered by an intramuscular injection (IM) on day 1 of each 21-day cycle."
15792885|NCT04509466|Drug|Part 2 (relapsed or refractory patients): Liposomal mitoxantrone hydrochloride and Pegaspargase|"Drug: Liposomal mitoxantrone hydrochloride (RP2D defined in Part 1) is administered by an intravenous infusion (IV) on day 1 of each 21-day cycle.
~Drug: Pegaspargase (2000IU/m2) is administered by an intramuscular injection (IM) on day 1 of each 21-day cycle."
15792886|NCT04509453|Device|McGRATH laryngoscopy|Patients who underwent general anesthesia with LMA insertion by using McGRATH video layngoscopy
15792887|NCT04509453|Device|Macintosh laryngoscopy|Patients who underwent general anesthesia with LMA insertion by using classic Macintosh video layngoscopy
15792888|NCT04509440|Drug|isotonic dextrose 5% in water (D5W) solution|Neurol prolotherapy (NP) is the subcutaneous perineural injection of isotonic dextrose 5% in water (D5W) solution.
15792889|NCT04509440|Drug|corticosteroid with local anaesthetics (40 mg of triamcinolone acetonide (40 mg/ml) with 1.5 ml mepivacaine HCl 3% )|Corticosteroid with local anaesthetics (40 mg of triamcinolone acetonide (40 mg/ml) with 1.5 ml mepivacaine HCl 3% ) (local anesthetic). They were given as a single local soft tissue injection at the point of maximal tenderness on the lower medial aspect of the knee region.
15792897|NCT04509401|Drug|Vitamin B 6 with Magnesium|Patients of intervention group will receive high dose of vitamin B6 with magnesium. This group will receive high dose of vitamin B6 with magnesium orally for 12 weeks.
15792898|NCT04509401|Drug|placebo of vitamin B6 and magnesium|Patients of control group will receive oral placebo tablet in the same manner, schedule for 12 weeks.
15792899|NCT04509388|Other|Composition of Sports Drink|The composition of sport drinks will be manipulated to determine the effect of drink composition on the appearance of ingested water in body fluid.
15792900|NCT04509375|Device|Cranial Doppler Ultrasonography|Before and after the transfusions, flow measurements of middle cerebral arteries will be obtained.
15792901|NCT04509375|Device|Near-Infrared Spectroscopy|Before, during and after the transfusions, regional cerebral oxygen saturation measurements will be obtained.
15792902|NCT04509362|Device|Advanced Hybrid Closed Loop System|Evaluation of the use of an 8-day structured protocol to initiate patients from MDI to the AHCL system, in achieving safe glycemic control
15792903|NCT04509349|Device|transcranial Altering Current Stimulation|The participant will wear an electrode cap with 5 gel-filled cup HD electrodes arranged in a 4 x 1 montage.
15792904|NCT04509349|Device|Sham tACS|2 saline sponge electrodes will be attached to the upper arm contralateral to hand attached to the accelerometer.
15792905|NCT04509336|Drug|Orphenadrine|100 mg twice daily
15792906|NCT04509336|Drug|Baclofen|initial dose of 10 mg tablet once daily, dose will be gradually increased according to the patients responses
15792907|NCT04509323|Drug|Huperzine A for Injection|Give the patient one intramuscular injection (0.2mg) of Huperzine A of injection once a day for 14 days
15792908|NCT04509310|Device|Active Bodysuits|The wear trial period will be 9-12 months for each subject depending on the active biofeedback training progress. The bodysuits should provide active biofeedback training to the users. By incorporating the IMU sensors, the body alignment in the sagittal or coronal planes can be detected to provide feedback to the users via a wireless platform. This training will be customized to each individual user and will achieve a uniform body alignment goal that benefits the user. The participants will be assessed using the Scoliosis Research Society questionnaire (SRS-22r), the Oswestry Disability Index (ODI) and health-related quality-of-life (HRQOL) measures.
15792909|NCT04509297|Dietary Supplement|high protein milk|This intervention consisted of high protein milk consumption concomitant with 6 weeks of resistance training. Subject ingested consumed 1 x 250 mL immediately after resistance training and 1 x 250 mL half an hour before bedtime.
15792910|NCT04509297|Dietary Supplement|Placebo|This intervention consisted of the consumption of a maltodextrin drink with a 9% solution with a vanilla flavor concomitant with 6 weeks of resistance training. Subject ingested consumed 1 x 250 mL immediately after resistance training and 1 x 250 mL half an hour before bedtime.
15792911|NCT04509284|Other|Training|The experimental group will perform a supervised progressive resistance training program, with five exercises for the upper- and lower body (box squat, bench press, trap bar deadlift, bench pull and lat pulldown), 2x/week for a 12 week period. The program will utilize a flexible progression system through three distinct training phases; 1) 2-4 sets of 10-12 repetitions, 2) 2-4 sets of 6-8 repetitions, 3) 2-4 sets of 2-4 repetitions. Number of sets are adjusted within session according to daily readiness while load is adjusted within and between sessions according to number of reps performed. A 3-5min rest period is provided throughout the program.
15792912|NCT04509284|Other|Control|The control group will be instructed to continue their everyday lifestyle with no specific instruction regarding exercise and/or diet. However, they will be encouraged not to engage in new forms of exercise or physical activity throughout the study period.
15792913|NCT04509271|Diagnostic Test|MicRNAs battery kits|Novel peripheral blood diagnostic biomarker for MCI due to AD.
15792914|NCT04509258|Drug|N-acetyl cysteine|a drug which can have an off label use as an antidot for aluminium phosphide poisoning in addition to sodium bicarbonate and ondansetron as standard of care
15792915|NCT04509258|Dietary Supplement|acetyl L-carnitine|Naturallu occuring amino acid derivative which can be taken as a dietary supplement involves in mitochondrial function and energy production and is suggested to have a role in lowering organ damage resulting from aluminium phosphide poisonong in addition to sodium bicarbonate and ondansetron as standard of care
15792916|NCT04509258|Drug|medicated paraffin oil|refined mixture of liquid hydrocarbons which used as laxative and is suggested to reduce absorption of aluminium phosphide if taken within two hours of administration of the toxin in addition to sodium bicarbonate and ondansetron as standard of care
15792917|NCT04509258|Drug|Sodium Bicarbonate Powder and ondansetron|standard of care for treatment of aluminuim phosphide is provided for patients poisoned with aluminuim phosphide
15792918|NCT04509245|Behavioral|Low-calorie diet supported by an app-guided digital education program, nutritional coaching calls via phone|During the 12-week intervention participants were asked to adhere to a real food-based low-calorie diet supported by an app-guided digital education program as well as a low-calorie recipe book and received weekly coaching calls by nutritionists
15792919|NCT04509232|Procedure|Silver diamine fluoride|"Group A
~Excavation of soft carious dentin will be done to minimize the staining.
~The selected teeth should be cleaned, dried and isolated. Vaselline should be applied to surrounding soft tissues to avoid their staining.-
~38% Silver diamine fluoride will be applied to carious lesions by microbrush
~Apply gentle flow of air until medicament is dry, Try to keep isolated for three minutes,remove excess SDF with cotton pellet to decrease systemic absorption.
~After silver diamine fluoride application Assessement of parental acceptance to staining will be done though a 5 point likert scale For anterior and posterior teeth separately ."
15792920|NCT04509232|Procedure|Silver diamine fluoride and glass ionomer|"38% Silver diamine fluoride will be applied by the same protocol as in group A Then Glass Ionomer restoration is applied
~Parental acceptance to staining will be assessed thought 5 point likert scale after application of SDF and once more after application of Glass Ionomer restoration."
15792921|NCT04509219|Drug|Methylprednisolone Injection|methylprednisolone pulse therapy, 30mg/kg, with maximal dose of 1000mg/day, for continue 3 days.
15792922|NCT04509206|Behavioral|Nutritional education|The curriculum for the four classes include understanding MyPlate guidelines, learn basic knife skills, meal prep, and plan, home farming and no-cook cooking.
15792923|NCT04509193|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Participants receive rivaroxaban (per written prescription, medication administration or self-report of medication use)
15793185|NCT04506931|Other|CATI Survey|Participants will receive a CATI survey
15792924|NCT04509193|Drug|Warfarin|Participants receive warfarin (per written prescription, medication administration or self-report of medication use)
15792925|NCT04509180|Procedure|Catheter ablation|Endovascular approach
15792926|NCT04509180|Procedure|Convergent procedure|Surgical and endovascular approach
15792927|NCT04509167|Biological|Neoantigen Peptides|Patients will receive intradermal injection of individualized neoantigen peptides vaccine at a dose of ~500ug per peptide once a week for 8 weeks.
15792928|NCT04509154|Other|Multimodal pain therapy|For the elaboration of the contents of the multi-component treatment of the mobile device application (APP), a set of guidelines has been developed for the care of one's own health, based on scientific evidence and adapted to the language of citizens, applying participatory methodology (Loewenson et al. 2014) and consensus, both by professionals (physicians,, nurses, psychologists, pharmacists, social educators and health professionals), and expert patients, who guarantee their validity, allowing the analysis and selection of the interventions that respond to the health problem. This intervention consists in the implementation of a protocol of standard activities of the interactive psychosocial therapy type.
15792929|NCT04509154|Other|Standardized treatment.|Face-to-face health education sessions led by nurses and physicians, with the possibility to have access to a non-interactive website with pain management materials from a self-help approach.
15792930|NCT04509141|Other|acupuncture|acupuncture points used were EXHN5 Taiyang, GB20 Fengchi, TE5 Waigun, GB41 Zulinqi
15792931|NCT04509115|Drug|Short-acting opioid prescription for acute pain|Patients not currently using opioids who receive a new short-acting opioid prescription as part of routine care for acute pain will be recruited and followed prospectively for 180 days.
15792932|NCT04509102|Drug|Adderall-XR|Subjects randomized to Adderall XR will initiate treatment with 15 mg daily (one 15 mg tablet each morning) for 21 days.
15792933|NCT04509102|Drug|Placebo|Subjects randomized to placebo will take an identical-appearing tablet/capsule and, in order to maintain blinding, will also take one tablet by mouth daily. The placebo substance will be sugar for 21 days.
15792934|NCT04509089|Device|Suremedix Device|Performing measurements using the Suremedix Device by applying gradually ascending air pressure to the subject lungs through a mouse piece while measuring respiratory chest motion, PPG and ECG.
15792935|NCT04509076|Behavioral|PrEP iT! (plus usual PrEP care)|"The PrEP iT! intervention is a mobile-optimized website, with the following components:
~PrEP Adherence, PrEP Appointment, and Sexual Activity Self-Monitoring
~Tailored feedback on PrEP adherence/non-adherence
~PrEP and sexual health information tailored for YMSM
~Text message reminders for PrEP adherence and healthcare appointments
~An ask the expert feature"
15792936|NCT04509076|Behavioral|Usual PrEP care|Clinic visits every 3 months in the initial period following PrEP initiation, including HIV/STI screening and laboratory toxicity testing
15792937|NCT04509063|Behavioral|Information about hypothetical mammography screening without benefits|We will present an online questionnaire with two types of information on the harms of screening. Then we will compare the prevalence of irrational decisions in the two arms.
15792938|NCT04509050|Drug|Ivacaftor or elexacaftor/tezacaftor/ivacaftor|In Part B, approved CFTR modulator as prescribed at the discretion of the treating physician -not dictated by the BEGIN investigators
15792939|NCT04509024|Behavioral|Incidental training|Nonspeech perceptual building block categories are established, which may be used to scaffold language learning.
15792940|NCT04509024|Behavioral|Explicit training|Traditional explicit language training, which involves establishing sound to meaning.
15792941|NCT04509011|Device|Fluobeam® LX|Fluobeam®-LX is used to identify and evaluate parathyroid glands using auto-fluorescence during thyroid surgery.
15792942|NCT04508998|Diagnostic Test|Blood tests including genotyping|Blood tests for alternative SNPs altering levels of ET-A receptor expression; blood will be further analysed for endothelin receptor mRNA and other plasma peptides important in the endothelin signalling pathway
15792943|NCT04508998|Diagnostic Test|Exercise Tolerance Test|Treadmill exercise test using the Bruce protocol
15792944|NCT04508985|Other|Temporarily holding the RAAS inhibitor [intervention]|Temporarily holding the RAAS inhibitor. Among participants who will be randomized to the intervention arm, a possible guideline-directed alternative to anti-hypertensive medication alternatives will be provided to the treating physician team.
15792945|NCT04508985|Other|RAAS inhibitor [continued standard of care]|No intervention, Continuation RAAS inhibitor [continued standard of care].
15792946|NCT04508972|Device|Alexa Amazon|To test the use of the Amazon Alexa device as a tool to conduct screening of employees and patients at the point of entry into the Heart Failure (HF) Clinic of the McGill University Health Center.
15792947|NCT04508946|Drug|vitamin c - thiamine- hydrocortisone|Triple therapy regimen (vitamin c - thiamine- hydrocortisone)
15792950|NCT04508920|Other|Symptomatology, Treatment. daily Activities and Anxiety for Cardiovascular patients Survey (STRATA)|Interventions were recorded in two groups of patients, who were randomly selected, in two different periods of time. The basal group was intervened from 15 May to 15 June 2019, a pandemic-free period. The outbreak group from 15 May to 15 June 2020, corresponding to increased activity of contagiousness and mortality associated with COVID-19, in general population in Mexico14 Basal measurement was performed in a face to face method. In Outbreak period, under social isolation conditions, patients were evaluated by telephone. The assessments were performed out by medical staff with specialized training, with evaluations to which patients were accustomed by regular cohort assessments. The questions were ordered and systematized in a patient evaluation, care, and follow-up guide (appendix). A causality association question of emotional distress perception was added. We recorded mortality and rehospitalization
15792951|NCT04508907|Drug|Mavyret|Mavyret and Zetia for 8 days to prevent HCV infection in solid organ recipients
15792952|NCT04508894|Drug|Supraclavicular Brachial Plexus Block with bupivacaine|"drug: 20 ml 0.5%bupivacaine plus 20 ml 0.9% normal saline is administered around the brachial plexus on the operative side Drug: IM diclofenac sodium (75 mg amp) is injected if VAS more than 4.
~Device: ultrasound-guided supraclavicular Brachial Plexus nerve block"
15793186|NCT04506918|Other|IVR survey|Participants will receive an IVR survey
15793187|NCT04506918|Other|SMS survey|Participants will receive a SMS survey
15792953|NCT04508894|Drug|Supraclavicular Brachial Plexus Block with Ketamine|"drug: 20 ml 0.5%bupivacaine, 20 ml 0.9% normal saline plus 1mg\kg ketamine is administered around the brachial plexus on the operative side Drug: IM diclofenac sodium (75 mg amp) is injected if VAS more than 4.
~Device: ultrasound-guided supraclavicular Brachial Plexus nerve block"
15792954|NCT04508894|Drug|Supraclavicular Brachial Plexus Block with Dexmedetomidine|"drug: 20 ml 0.5%bupivacaine, 20 ml 0.9% normal saline plus 1µg\kg dexmedetomidine is administered around the brachial plexus on the operative side Drug: IM diclofenac sodium (75 mg amp) is injected if VAS more than 4.
~Device: ultrasound-guided supraclavicular Brachial Plexus nerve block"
15792955|NCT04508881|Device|Ahmed Glaucoma Valve|To compare the prevalence of postoperative hypotony between the 2 arms
15792956|NCT04508868|Behavioral|Brief Behavioral Activation with Mental Imagery|"Session 1:
~Provide psychoeducation about depression; Provide treatment rationale for BA; Provide rationale and instructions for activity log; Plan activities for coming week.
~Session 2:
~Review activity log; Discuss life goals and values; Plan activities aligned with life goals and values for coming week; Provide rationale for Mental Imagery (MI); Go through MI-exercise for one of the planned activities.
~Session 3:
~Review activity log; Troubleshoot any problems carrying out activities; Plan activities aligned with life goals and values for coming week; Go through MI-exercise for one of the planned activities.
~Session 4:
~Review activity log; Troubleshoot any problems carrying out activities; Review treatment; Stress the importance of continuing to engage in activities aligned with life goals and values; Referral to additional services if necessary."
15792957|NCT04508868|Behavioral|Minimal Attention Control Intervention|Weekly call with follow-up of psychiatric symptoms and assessment of suicide risk.
15792958|NCT04508855|Drug|Low molecular weight heparin|Switch from direct oral anticoagulants to low molecular weight heparin
15792959|NCT04508842|Biological|CD19/CD22-Dual-STAR-T|Patients with B cell acute leukemia will be enrolled, and Subjects will receive cytoreductive chemotherapy with cyclophosphamide and fludarabine on days -5, -4 and -3 followed by infusion of CD19/CD22-Dual-STAR-T cells.Dual-STAR-T cells will be intravenously infused with a escalated dose of 6E5、1E6、2E6、3E6 cells/kg.
15792960|NCT04508829|Drug|Anti-EGFR monoclonal antibody|The patients will receive IMRT combined with anti-EGFR monoclonal antibody concurrent chemoradiotherapy in locally advanced oropharyngeal carcinoma with induced chemotherapy resistance. The specific treatment description is included in arm description.
15792961|NCT04508816|Drug|cetuximab (CTX) or nimotuzumab (NTZ)|The patients will receive IMRT combined with anti-EGFR monoclonal antibody concurrent chemoradiotherapy. The specific treatment description is included in arm description.
15792962|NCT04508803|Drug|HX008，Niraparib|Subjects received intravenous HX008 at a fixed dose of 200mg, administered every 3 weeks, and 200mg of Niraparib orally per day.Every 3 weeks is a cycle.
15792963|NCT04508803|Drug|HX008，Niraparib|Subjects received intravenous HX008 at a fixed dose of 200mg, administered every 3 weeks, and 200mg of Niraparib orally per day.Every 3 weeks is a cycle.
15792964|NCT04508803|Drug|HX008，Niraparib，Trastuzumab|Subjects received intravenous HX008 at a fixed dose of 200mg once every 3 weeks; 200mg Niraparib orally per day;Trastuzumab 8mg/kg in the first cycle and 6mg/kg after the first cycle intravenously once every 3 weeks; Every 3 weeks is a cycle.
15792965|NCT04508803|Drug|HX008，Niraparib，Pyrrolitinib|"HER-2 negative subjects received intravenous HX008 at a fixed dose of 200mg, administered every 3 weeks, and 200mg of Neirapali orally per day. Every 3 weeks is a cycle.
~Her-2 positive subjects received intravenous HX008 at a fixed dose of 200mg once every 3 weeks; 200mg Niraparib orally per day; Pyrrolitinib is taken orally at 400mg per day; Every 3 weeks is a cycle."
15792966|NCT04508790|Drug|Dexamethasone|Given PO
15792967|NCT04508790|Drug|Leflunomide|Given PO
15792968|NCT04508790|Drug|Pomalidomide|Given PO
15792969|NCT04508777|Behavioral|Saliva-based testing|Participants will take part in a voluntary COVID-19 screening program that includes bi-weekly saliva-based testing.
15792971|NCT04508751|Other|"3T Free-Breathing Fetal Magnetic Resonance Imaging"|Subject will have a one time MRI scan.
15792972|NCT04508738|Other|ERP|"The ERP intervention is applied in a randomized and counter-balanced order across visits 2-4 in each 3-min break in-between the six 30-s sprints, with one intervention per visit. The order and timing of the constituents of the interventions will be strictly constant within and between participants.
~ERP: 1) neck cooling with an iced gel pad, 2) drinking a ∼ 6% CHO solution, 3) mouth-rinsing with a ∼10% CHO, ∼6 mg ･ kg -1 caffeine solution, 4) performing submaximal squats and 5) hyperventilating a hyperoxic mixture"
15792973|NCT04508738|Other|Placebo|"The control intervention is applied in a randomized and counter-balanced order across visits 2-4 in each 3-min break in-between the six 30-s sprints, with one intervention per visit. The order and timing of the constituents of the interventions will be strictly constant within and between participants.
~1) neck cooling with room temperature gel pack, 2) drinking an artificially sweetened solution, 3) mouth-rinsing with artificially sweetened solution (containing no caffeine), 4) performing unloaded squat manoeuvres, 5) deep breaths with room air"
15792974|NCT04508725|Diagnostic Test|Doppler Ultrasound|Power doppler measurements will be made
15792975|NCT04508725|Device|Vantage 256 with C5-2v transducer|Vantage 256 with C5-2v transducer, used for power doppler ultrasound, manufactured by Verasonics
15792976|NCT04508699|Other|semantic learning|Experimental semantic learning from linguistic context task
15792977|NCT04508686|Drug|Capecitabine, camrelizumab|This is a single-arm study with all patients receiving these two drugs.
15792978|NCT04508673|Other|GH provocation tst|All patients underwent insulin-induced hypoglycaemia stimulation test also called insulin tolerance test (ITT), considered the 'gold standard' test for GHD diagnosis. Following insulin administration by venipuncture (1UI/mL), levels of hGH and glucose were monitored on serum and fluoride tube plasma, respectively, at intervals of 0, 30, 45, 60 and 90 minutes (T0, T30, T45, T60 and T90).
15792979|NCT04508660|Drug|CGB-400|BID application
15793188|NCT04506905|Drug|MK-8189|MK-8189, oral, 4 mg and/or 12 mg tablets for a total daily dose of 8, 16 or 24 mg QD according to randomization
15792980|NCT04508647|Drug|Ublituximab|"Ublituximab will be administered as an intravenous infusion through a dedicated line. All infusions will be administered per institutional guidelines.
~During ublituximab monotherapy (initial treatment), Cycle 1 Day 1 administration time frame: Over 4 hours. Cycle 1 days 8 and 15 will be over 3 hours, and Cycle 1 Day 22 will be over 90 minutes. During combination treatment with umbralisib, ublituximab will be administered over 90 minutes."
15792981|NCT04508647|Drug|Umbralisib|Umbralisib will be administered orally once daily within 30 minutes of starting a meal.
15792982|NCT04508634|Procedure|laparoscopic sleeve gastrectomy|laparoscopic sleeve gastrectomy
15792983|NCT04508634|Drug|Metformin Pill|Metformin 1000mg bid
15792984|NCT04508621|Drug|TNX-102 SL|Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patient will have the dose increased to 2 tablets for 12 weeks.
15792985|NCT04508621|Drug|Placebo SL Tablet|Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patient will have the dose increased to 2 tablets for 12 weeks.
15792986|NCT04508608|Diagnostic Test|Stress Gated blood pool SPECT|"After labeling of red blood cells in vivo, a sequential series of acquisition is carried out at rest and during increasing doses of dobutamine (5/10/15 μg / kg / min). The duration of acquisition is 300 seconds.
~The acquisitions are carried out on dedicated cardiac gamma-camera with ultrafast Cadmium zinc telluride (CZT) detectors (DiscoveryNM530c, General electric Healthcare Israel, Israel)"
15792987|NCT04508608|Diagnostic Test|Dynamic SPECT|"The passage of a radiopharmaceutical bolus through the cavities of the heart and myocardium at rest and during infusion of adenosine at a dosage of 140 mcg / kg / min (for 4 minutes) is recorded.
~At the peak of the stress test (after 2 minutes of administration of adenosine), a 5 ml bolus (dose 260-444 MBq) of 99mTc-methoxyisobutylisonitrile (MIBI) is administered at a rate of 1 ml / s. Immediately after the end of tracer administration, 30 ml of 0.9% sodium chloride (NaCl) is infused. A scintigraphic recording of the study begins 5 seconds before the administration of the radiopharmaceutical.
~The next day, the study at rest is carried out. Scintigraphic images are recorded in tomographic mode with ECG synchronization for 600 s, at list mode.
~The acquisitions are carried out on dedicated cardiac gamma-camera with ultrafast CZT detectors (DiscoveryNM530c, General electric Healthcare Israel, Israel)"
15792988|NCT04508595|Diagnostic Test|RestEaze|Wearable band to detect leg movements of sleep
15792989|NCT04508582|Diagnostic Test|Cardiovascular magnetic resonance|Imaging of the heart with CMR, without use of contrast agents.
15792990|NCT04508582|Diagnostic Test|Echocardiography|Imaging of the heart with ultrasound.
15792991|NCT04508582|Diagnostic Test|Blood test|Time- matched blood samples will be taken from patients to assess immune cell phenotype and function, paying particular attention to neutrophil and T-cell phenotype. Plasma samples will be collected for the analyses of cardiac specific factors (BNP, troponin) as well as measurement of steroid hormones (progesterone and oestradiol), and soluble inflammatory and anti-inflammatory mediators
15792992|NCT04508569|Behavioral|Big Decisions|Big Decisions is a promising teen pregnancy prevention intervention that consists primarily of abstinence-plus sexual health education curriculum. The intended dosage for students is 10 classroom-based sexual health lessons.
15792993|NCT04508556|Device|Breath Biopsy face masks with removable filters and fitted PVA strip|Device developed for collection of breath samples
15792994|NCT04508556|Diagnostic Test|Nasopharyngeal swab|Is a method for collecting a clinical test sample of nasal secretions from the back of the nose and throat.
15792995|NCT04508556|Diagnostic Test|oropharyngeal swabs|Is a method for collecting a clinical test sample from the back of the throat.
15792996|NCT04508543|Other|Non-verbal communication score|1. To compare nonverbal communication score (NCS, range 0 - 4) between minority and Caucasian non-Hispanic patients. The score is a sum of four components, each contribute to a score range 0 - 1. The four components are: percent time spent with open body language, percent time spent interacting with the patient or surrogate, distance from the patient along the long axis of the patient's body (distance from the head), and distance from the patient along the axis perpendicular to the patient's body (distance from the handrail).
15792997|NCT04508530|Biological|Panzyga|Panzyga 10% IVIG
15792998|NCT04508530|Other|Placebo|Placebo
15792999|NCT04508504|Procedure|Preop PENG block|Ultrasound-guided injection of 20 mL 0.5% ropivacaine according to the method described by Giron-Arango L in 2018. A needle is inserted at the inguinal level under ultrasound guidance to pass beneath the psoas tendon on top of the iliopubic eminence where the local anesthetic is injected.
15793000|NCT04508504|Procedure|Placebo block|Ultrasound-guided placebo injection of 5 mL 0.9% normal saline. Using the same landmarks as for the PENG group, a needle is inserted in the inguinal region under ultrasound guidance, whereby a subcutaneous injection of 5 mL of 0.9% saline is made.
15793001|NCT04508504|Drug|Ropivacaine 0.5% Injectable Solution|20 mL 0.5% ropivacaine will be injected for the preop PENG block
15793002|NCT04508504|Drug|Normal Saline|5 mL 0.9% Normal saline will be injected for the Placebo block
15793003|NCT04508491|Other|Rhythm control|Rhythm control with medications or any procedure
15793004|NCT04508491|Other|Rate control|Rate control
15793005|NCT04508478|Behavioral|Aerobic training|Aerobic training
15793006|NCT04508478|Behavioral|Resistance training|Resistance training
15793007|NCT04508478|Behavioral|Control physical exercise|Control physical exercise
15793008|NCT04508452|Drug|Capecitabine-Oxaliplatin-Irinotecan-Bevacizumab Combination|CAP 1,600 mg/sq.m /day (p.o. day1-10) D1-10; Oxaliplatin (OX): 68 mg/sq.m (d.i.v.) D1; Irinotecan (IRI):135 mg/sq.m (d.i.v.) D1; BEV: 5mg/kg (d.i.v.) D1; Administered every 2 weeks.
15793009|NCT04508439|Drug|Enoxaparin|Identify the benefit of different doses of low molecular weight heparin (enoxaparin) on the established clinical response due to lack of ventilatory support, length of hospital stay or death in patients requiring hospital care for COVID-19 infection.
15793010|NCT04508426|Drug|[14C]AR882|Single dose of [14C]AR882
15793011|NCT04508413|Other|KB295|KB295 is a novel glycan
15793012|NCT04508400|Drug|Fosaprepitant|Participants will randomly assigned 1:1 to receive double-blind study drug ( fosaprepitant plus ondansetron with dexamethasone OR placebo plus ondansetron with dexamethasone). Fosaprepitant or placebo to fosaprepitant were supplied and administered in a blinded manner.
15793013|NCT04508400|Drug|placebo ondansetron with dexamethasone|placebo plus ondansetron with dexamethasone
15793014|NCT04508387|Procedure|Group HH (heated-humidified)|Group CD patients were administered dry CO2 via insufflator at room temperature (21°C), while Group HH patients were administered 95% humidified CO2 insufflation at 37°C. The study was planned as a randomized and double-blind study, where patients were not informed of their group. During the operation and in the postoperative period, the patients were followed up by two different anesthetists. All patients were given information and training on the anesthesia method, the use of the patient-controlled-analgesia device and the visual analog scale the day before the operation. The patients' demographic data (age, weight, height, etc.) and their basal systolic, diastolic and mean blood pressures and heart rates were measured prior to the operation and recorded on the case report form. Both groups received the standard general anesthesia protocol. Laparoscopic surgery was performed in the same manner for all cases by AA.
15793015|NCT04508374|Procedure|1470 nm intra-lesional diode laser treatment of right HS tunnel|Ten patients: 1470 nm intra-lesional diode laser treatment of right HS-tunnel randomized to active treatment.
15793016|NCT04508374|Procedure|1470 nm intra-lesional diode laser treatment of left HS tunnel|Ten patients: 1470 nm intra-lesional diode laser treatment of left HS-tunnel randomized to active treatment.
15793017|NCT04508348|Other|Human Milk|Exclusive Human Milk diet
15793018|NCT04508348|Other|Standard of Care|This diet will include mother's milk and/or formula
15793019|NCT04508322|Device|HGA|Headgear Activator
15793020|NCT04508322|Device|FA|Fixed Orthodontic Appliance
15793023|NCT04508296|Diagnostic Test|Goal directed de-escalation therapy|Patients received de-escalation fluid management using either diuretics or ultrafiltration during continuous RRT in the case of GEDVI > 650 mL/m2 or EVLWI > 10 mL/kg depending on the randomization group. The primary goal of de-escalation was to obtain a cumulative fluid balance after 48 hrs from the study baseline of 0 to -3000 mL. In the case of GEDVI < 650 mL/m2 or EVLWI < 10 mL/kg, the target fluid balance was in the range of 0 to +3000 mL
15793024|NCT04508270|Behavioral|Early mobilization|Mobilization as soon as patients can, which is not limited on walking
15793025|NCT04508257|Dietary Supplement|Oral feeding of Investigational Formula (Stage 1&2)|Participants will receive stage 1 formulas up to 180 days of age and then switch to stage 2 formulas though 365 days of age.
15793026|NCT04508257|Dietary Supplement|Oral feeding of Control formula (Stage 1&2)|Participants will receive stage 1 formulas up to 180 days of age and then switch to stage 2 formulas though 365 days of age.
15793027|NCT04508257|Dietary Supplement|Breast feeding|Exclusively breastfed for the first 4 months and continue with supplement food without any marketed infant formula.
15793028|NCT04508244|Drug|Placebo|12 ampoules of 1 mg placebo solution (3 ampoules/day for 2 days; 2 ampoules/day for day-3 & 4 and 1 ampoule/day for day-5 & 6.
15793029|NCT04508244|Drug|Propranolol|12 ampoules of 1 mg placebo solution (3 ampoules/day for 2 days; 2 ampoules/day for day-3 & 4 and 1 ampoule/day for day-5 & 6.
15793030|NCT04508231|Other|Gender-affirming hormone therapy|Gender-affirming hormone therapy according to the recommendations of the Endocrine Society
15793031|NCT04508218|Dietary Supplement|whey protein supplementation powder (Inkospor X-TREME; France)|Protein requirements for burned adults are estimated as 1.5-2.0 g/kg/day. The participants asked to take the calculated serving of whey protein dissolved in 150ml of water two times / day in the morning and in the evening
15793032|NCT04508218|Other|Exercise training program|After healing of the burn (6 weeks after injury), participants in group A and group C started resisted exercise program with a qualified therapist for 1 hour three times/week on nonconsecutive days over 12 weeks. In addition, aerobic exercises were conducted on the treadmill. Peak oxygen consumption was assessed for all patients by using the exercise test on treadmill before participation in aerobic exercises.
15793033|NCT04508218|Other|traditional burn care|ROM exercises, stretching, ADL activities and scar management
15793034|NCT04508205|Drug|CGB-400|BID application
15793035|NCT04508192|Other|Exercise|Both interventions are simple strength exercises without technical equipment
15793036|NCT04508179|Drug|7HP349 Single Ascending Dose|Part A: 7HP349 Capsules, Single Ascending Dose (SAD)
15793037|NCT04508179|Drug|7HP349 Multiple Ascending Dose|Part B: 7HP349 Capsules, Multiple Ascending Dose (MAD)
15793038|NCT04508179|Drug|Placebo Single Ascending Dose|Part A: Placebo Capsules, Single Ascending Dose (SAD)
15793039|NCT04508179|Drug|Placebo Multiple Ascending Dose|Part B: Placebo Capsules, Multiple Ascending Dose (MAD)
15793040|NCT04508179|Drug|7HP349 Food Effect|Part C: 7HP349 Capsules, Food Effect
15793041|NCT04508166|Drug|Dexmedetomidine|Volunteers receive a single dose of dexmedetomidine sublingually at scheduled bedrest in the sleep laboratory
15793042|NCT04508166|Drug|Gamma-Hydroxybutyrate|Volunteers receive a single oral dose of gamma-hydroxybutyrate at scheduled bedrest in the sleep laboratory
15793043|NCT04508166|Drug|Placebo|Volunteers receive an oral (saline) or sublingual (orodispersible tablet) at scheduled bedrest in the sleep laboratory
15793044|NCT04508166|Behavioral|Experimental Model Trauma Film|Each volunteer views experimental model trauma film before scheduled bedrest in the sleep laboratory. This video is ca. 15 minutes in duration and is composed of short (a few seconds to a few minutes) individual and unrelated scenes of violent death and injury of varying description. Six versions of the film without re-occurring scenes will be presented in balanced order across drug order conditions.
15793045|NCT04508153|Device|Leva Pelvic Digital Health System|Pelvic floor muscle training using the pelvic digital health system to treat pelvic floor disorders, specifically stress urinary incontinence.
15793046|NCT04508153|Other|Kegel exercises|"Pelvic floor muscle training (PFMT), commonly referred to as Kegel exercises, is a first line conservative treatment for pelvic floor disorders, specifically stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence (SMUI)."
15793047|NCT04508140|Procedure|Hepatic Biopsy|In this trial a biopsy from the hepatic lesion to be injected will be mandatory on C1D1 and C2D1, prior to the BO-112 administration. On the same timepoints, a biopsy from a non-hepatic, non-injected lesion will be optional.
15793189|NCT04506905|Drug|Placebo|Oral tablets of dose-matched placebo to MK-8189 according to randomization
15793263|NCT04506281|Drug|neoadjuvant treatment|PD1 antibody (Toripalimab) combined with GEMOX chemotherapy and Lenvatinib neoadjuvant treatment
15793048|NCT04508140|Drug|BO-112 with Pembrolizumab|. The study treatment consists of the combination of BO-112 given intratumorally inside the liver metastasis at the dose of 1gm in 1.2 mL in combination with intravenous pembrolizumab given at the fixed dose of 200 mg. This treatment will be given every 3 weeks, with a maximum duration of 35 cycles (2 years). Of note, during the first cycle, BO-112 will be administered on D1 and D8.
15793049|NCT04508127|Device|Spinal cord stimulation|
15793050|NCT04508114|Behavioral|Technology-assisted Index|The participant will be informed the ATP testing result and explanation in pretest.
15793051|NCT04508088|Diagnostic Test|Coronal T1 weighted spin echo images|Coronal T1 weighted spin echo images will be obtained through the knee with a field of view of 16cm to include distal femoral and proximal tibial metaphyses.
15793052|NCT04508088|Diagnostic Test|Spin-lattice relaxation (T1)|Spin-lattice relaxation (T1) relaxometry acquisition consisting of seven fast spin echo (FSE) acquisitions through the knee. T1 maps from the T1 relaxometry images will be generated using a two-parameter-fit iterative algorithm developed in-house using IDL software (Harris Geospatial Solutions, Melbourne, FL, USA). Mean T1 values for each region will be recorded. The anatomical locations of these regions will be consistent in size for all subjects and location. The locations chosen for the primary endpoints are ones that are known to be rich in red and yellow marrow, respectively.
15793053|NCT04508088|Diagnostic Test|Magnetic resonance spectroscopy|Magnetic resonance spectroscopy. MRS will be performed within a 1 mL voxel situated in the medial aspect of the distal femoral metaphysis. A single voxel point resolved spectral acquisition (PRESS) technique will be used to acquire non-water suppressed spectra at echo times of 20, 30, 40, and 50 ms using 32 signal averages per echo time with a TR of 2.5 s (total scan time = 5.4 minutes). Spectral fits using JMRUI MRS processing software (www.jmrui.eu) to the water and methylene/methyl resonances will be used to quantify peak areas and establish T2 corrected fat/(fat + water) ratios.
15793054|NCT04508075|Biological|SARS-CoV-2 vaccine (inactivated)|SARS-CoV-2 vaccine (inactivated) manufactured by Sinovac
15793055|NCT04508075|Biological|Placebo|Placebo manufactured by PT. Bio Farma
15793056|NCT04508062|Procedure|pectopexy operation|Vaginal cuff or uterine cervix will be attached to iliopectineal ligament with polypropylene mesh on both sides.
15793057|NCT04508062|Procedure|uterosacral ligaments plication operation.|At least 2/3 of the sacrouterine ligaments will be shortened with helical sutures, starting from the cervix and so douglas will be partially obliterated.
15793059|NCT04508036|Diagnostic Test|Withdrawal of blood samples for D-Dimer|Blood samples are withdrawn at birth via cord blood and at postnatal 3rd and 7th days via umbilical catheter in order to test for D-dimer levels.
15793060|NCT04508036|Diagnostic Test|Withdrawal of blood samples for Fibrinogen|Blood samples are withdrawn at birth via cord blood and at postnatal 3rd and 7th days via umbilical catheter in order to test for Fibrinogen levels.
15793061|NCT04508036|Diagnostic Test|Echocardiographic Examination|At postnatal 3rd, 7th and 14th days, Ductus Arteriosus will be echocardiographically examined to obtain calculations and confirm status of ductal patency or closure.
15793065|NCT04508010|Other|IVR|Participants will receive an IVR survey
15793066|NCT04508010|Other|CATI|Participants will receive a CATI survey
15793067|NCT04507984|Diagnostic Test|Genetic analysis|After obtaining written consent from patients, DNA is isolated, and genetic analysis of the know familial hypercholesterolemia disease-causing genes (LDLR, APOB, PCSK9) is performed.
15793068|NCT04507984|Diagnostic Test|Lipid levels measurement|Measurements of lipid levels (total cholesterol, LDL-cholesterol, HDL-cholesterol, TG) using standard methods.
15793069|NCT04507971|Biological|MET-3|Human microbiome supplementation derived from bacterial strains isolated from fecal matter and grown in a laboratory environment
15793070|NCT04507958|Diagnostic Test|auscultation by using conventional stethoscope without PPE|In thoracic patients undergoing general anesthesia with endotracheal tube/endobronchial blocker, Clinician will check the position of endotracheal tube and endobronchial blocker under fiberscope. Afterward, investigator A will perform auscultation with traditional auscultation, then investigator B with electronic stethoscope under full PPE, to examine bilateral breathing sound.
15793071|NCT04507958|Diagnostic Test|auscultation by using electronic stethoscope in full PPE|In thoracic patients undergoing general anesthesia with endotracheal tube/endobronchial blocker, Clinician will check the position of endotracheal tube and endobronchial blocker under fiberscope. Afterward, investigator A will perform auscultation with traditional auscultation, then investigator B with electronic stethoscope under full PPE, to examine bilateral breathing sound.
15793072|NCT04507945|Drug|Nutritional Therapy, Metabolic Disorder, Regular|According to the result reported by Byrne, Wilmore, etc. in 1992 ~ 1995, the use of growth hormone, glutamine, modified diet and other measures proposed intestinal rehabilitation treatment. Then, check the patient's quality of life survey, nutritional status, inflammation indicators and other changes every three months, and use metabolomics and microbiomic tools to detect changes in the patient's nutritional metabolism, intestinal microecology, etc., and adjust the patient's nutritional treatment and microecological treatment based on the results Program.
15793073|NCT04507932|Drug|68Ga-FAPI|Intravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-FAPI. Tracer doses of 68Ga-FAPI will be used to image lesions of inflammatory bowel disease by PET/CT.
15793074|NCT04507919|Drug|Dabrafenib|150 mg
15793075|NCT04507919|Drug|Trametininb|2.0 mg
15793190|NCT04506879|Procedure|Popliteal Sciatic nerve block|Patients schedule for lower limb surgery under regional anesthesia will receive ultrasound guided subparaneural popliteal sciatic nerve block. After identification of the common peroneal nerve and tibial nerve, local anesthetic agents will be injected close to each nerve below the point of divergence at the popliteal fossa. The spread of the drug and the sensory and motor function of that limb will be assessed regularly till it is ready for surgery.
15793076|NCT04507906|Drug|Nivolumab Combined with Anlotinib|In combination dose finding phase, Phase 1b will begin with Dose Level 1; anlotinib 12 mg/day orally (from days 1 to 14 in a 21-day cycle) and nivolumab (360mg q3w, intravenously) will be administered to eligible subjects on a 21-day treatment cycle. Two dose de-escalation steps are included: Dose Level 2 (anlotinib 10 mg/day orally, from days 1 to 14 in a 21-day cycle) and nivolumab 360mg q3w, intravenously) and Dose Level 3 (anlotinib 8 mg/day orally, from days 1 to 14 in a 21-day cycle) and nivolumab 360mg q3w, intravenously).If RP2D was reached in Part A, eligible patients would be enrolled and receive nivolumab (360mg q3w, intravenously) plus anlotinib (RP2D, QD from day 1 to 14 of a 21-day cycle) .
15793077|NCT04507893|Other|Clinical, laboratory and imaging characteristics of pneumonia|"Evaluation of the clinical, laboratory and imaging characteristics in patients with clinical presentation suggestive of COVID-19 infection, classified according to the results of PCR assay for COVID-19 on naso-pharyngeal swab as COVID-19 patients and negative COVID-19 patients."
15793078|NCT04507880|Device|Reverse Total Shoulder Arthroplasty|The RTSA (GLOBAL UNITE Reverse Fracture System) from DePuy Synthes.
15793079|NCT04507880|Device|Hemiarthroplasty|The shoulder hemiarthroplasty
15793080|NCT04507867|Dietary Supplement|Nutritional support system (NSS)|"Combination of three B vitamins (B1, B6 and B12) Neurobion 10 mg solution for IM injection, One every 24 hours for the first 5 days.
~Probiotics Saccharomyces boulardii CNCM I-745 Floratil. One morning and one evening 250 mg capsule during the first 6 days
~One envelope of NSS-1 in the morning and one envelope in the afternoon mixed with 400 ml of water each, contain nutritional support system."
15793081|NCT04507867|Other|Conventional nutritional support designed by hospital nutritionists|Diet designed by the nutrition department according to comorbidities and intubation probability. Food will be established according to the provisions of the ISSEMYM Toluca Arturo Montiel Rojas Medical Center.
15793082|NCT04507854|Other|Strength, range of motion and functional tests + Questionnaire|Patients undergoing instability surgery will perform amplitude, strength, functional tests and a questionnaire at 6 months of the operation. Then they will be contacted at 12, 18 and 24 months to find out if they have regained their performance level or if they have injured their shoulder again.
15793084|NCT04507828|Radiation|Treatment Planning using the DIBH Technique|Different radiation plans will be generated-one using a DIBH scan with corresponding target and normal tissue contour and a second using an expiration scan with corresponding target and normal tissue contours. The expiration scan can be an expiratory gating scan averaging the expiratory breathing phases or an expiration breath hold scan as determined based on patient performance during simulation and relative tumor displacement compared to the DIBH scan. Then a third plan will be generated conceptually combining the two previous plans, named the DIBH-expiration composite plan.
15793085|NCT04507815|Device|Active Transcranial Direct Current Stimulation (tDCS)|Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes.
15793086|NCT04507815|Device|Sham Transcranial Direct Current Stimulation (tDCS)|Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning and end of session).
15793087|NCT04507802|Device|Non invasive ventilation via helmet|Patients requiring long hours of noninvasive ventilation via facemask will switch to non-invasive ventilation using a helmet
15793088|NCT04507789|Other|exercise intervention|Exercise protocol will consist of the recommended special exercise sets for upper extremity problems on mastectomy patients. The upper extremity protocol has published in 2018 by Richmond and friends called prevention of musculoskeletal shoulder problems after breast cancer treatment UK-PROSPER protocol.this special protocol has unique exercise sets for to restore shoulder range of motion, to maintain good force level of upper extremity muscles and stretch exercises especially to the muscles around the radiotherapy area. Exercises will be done under the supervision of a specialized physiotherapist about upper extremity disorders.
15793089|NCT04507789|Other|routine radiotherapy protokol|This intervention is only an observation to patients during their routine radiotherapy protocol. There will be no exercise intervention for the upper extremity for the patient in this group.
15793090|NCT04507776|Drug|Etanercept|Patients with spondyloarthrosis as provided in real world practice
15793092|NCT04507750|Drug|Camrelizumab|Carmelizumab: Intravenous infusion of a fixed dose of 200 mg in 30 minutes (not less than 20 minutes, not more than 60 minutes), once every 3 weeks, continuous administration until the disease progresses, the patient If death or intolerable toxicity occurs, medication for up to 1 year; Apatinib mesylate tablets: The initial dose is 250 mg, administered once a day, and continue to be administered. If there is a grade 3 to 4 adverse reaction, it should be administered once every other day.
15793093|NCT04507737|Other|Rapid Response Team Composition_ ICU Nurse|In case of deterioration a Rapid Response Team may be activated. We will be examining the composition of the teams alternating between a MET or a CCOT.
15793094|NCT04507711|Drug|0 ul of palonosetron|Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0 ul) using palonosetron
15793095|NCT04507711|Drug|0.2 ul of palonosetron|Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0.2 ul) using palonosetron
15793096|NCT04507711|Drug|2.0 ul of palonosetron|Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (2.0 ul) using palonosetron
15793097|NCT04507711|Drug|4 ul of palonosetron|Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (4.0 ul) using palonosetron
15793098|NCT04507698|Other|Intensive Exercise Intervention|INTense Exercise foR surVivAL among Men with Metastatic Castrate-Resistant Prostate Cancer (INTERVAL - MCRPC), randomised to either the supervised exercise arm or the self-directed exercise arm.
15793191|NCT04506866|Device|InterStim Micro|Eligible subjects will receive InterStim Micro therapy. Commercial devices will be used within their intended use as described in each geography's approved instructions for use
15793099|NCT04507685|Other|Lifestyle (Diet and Exercise)|"The LG diet will comprise 20% carbohydrate, 30% protein, and 50% fat (<10% saturated fat). It will have a low glycaemic load; include plant and animal protein; non-starchy vegetables and salad greens; and some low-sugar fruit. Participants will be encouraged to incorporate a variety of foods rich in monounsaturated and polyunsaturated fats in their diet.
~The control diet will comprise 50% carbohydrate, 20% protein and 30% total fat (<10% saturated fat). It will reflect the Health Promotion Board's (HPB) recommendations to reduce dietary fat, emphasize wholegrains and include a variety of fruits and vegetables. In contrast to the LG diet, the control diet will have a higher glycaemic load with a greater proportion of energy derived from unrefined carbohydrate foods.
~Concurrent to the dietary intervention and consistent with physical activity guidelines, all participants will undertake a 60-min structured exercise program incorporating aerobic/ resistance exercises 3-4 days/week."
15793100|NCT04507672|Drug|Fluid resuscitation|Use the choice of crystalloid for resuscitation during the first 72 hours after enrollment
15793101|NCT04507659|Drug|Jaktinib Hydrochloride Tablets|Morning: 2*50mg simulated tablets and 1*75mg Jaktinib Hydrochloride Tablets; Evening: 2*50mg simulated tablets and 1*75mg Jaktinib Hydrochloride Tablets.
15793102|NCT04507659|Drug|Jaktinib Hydrochloride Tablets|Morning: 1*75mg simulated tablet, 2*50mg Jaktinib Hydrochloride Tablets; Evening: 1*75mg simulated tablet, 2*50mg Jaktinib Hydrochloride Tablets.
15793103|NCT04507659|Drug|Placebo|Morning: 1*75mg simulated tablet, 2*50mg simulated tablets; Evening: 1*75mg simulated tablet, 2*50mg simulated tablets.
15793104|NCT04507646|Other|True auricular acupuncture|The participant in experimental group will receive acupuncture on ear Shenmen point, ear zero point, and Salivary glands.
15793105|NCT04507646|Other|sham auricular acupuncture|The participant in control group will receive acupuncture on ineffective point at ear.
15793106|NCT04507633|Behavioral|ROMA therapy(reminiacence therpy, orientation, music, and art)|An intervention comprising reminiscence of annual festivals, orientation, and familiar music listening and singing, and animation interaction to improve cognitive functions, depressive symptoms and behaviors problems.
15793107|NCT04507620|Device|cervical neck collar|devices used for cervical immobilization
15793108|NCT04507607|Drug|Tenofovir Alafenamide 25 MG|TAF was administered to pregnant women with CHB during pregnancy for mother-to-child interention.Women with chronic hepatitis B who are not pregnant receive TAF for antiviral treatment.
15793109|NCT04507594|Procedure|Lung lobectomy OR esophagus cancer resection|Lunge lobectomy (total) Resection of esophagus cancer
15793111|NCT04507568|Other|Quality of Life Questionnaires|Quality of Life questionnaires will be administered to both arms at baseline, and at the first and last day of treatment.
15793112|NCT04507555|Procedure|Pharmacist-guided pharmacogenetic (PGx) testing for antidepressant selection and dosing|"The study intervention is the service of pharmacist guided pre-emptive PGx testing to support clinical decision making for antidepressant selection and dosing.
~This service involves genotyping and thereof evidence-based genotype interpretation commercially offered as Stratipharm® (humatrix AG, Pfungstadt Germany, https://www.stratipharm.de). Furthermore, clinical pharmacists will process and evaluate the results from PGx testing (Stratipharm®) in context of the individual patient medication history as well as current co-medication and forward an individualized recommendation for antidepressant selection and dosing to the treating psychiatrist."
15793113|NCT04507555|Procedure|Standard care antidepressant selection and dosing|Selection and dosing of the new antidepressant pharmacotherapy will be determined by the treating investigator alone, according to current standard of care considering clinical factors only.
15793114|NCT04507542|Behavioral|Enriched Music-Supported Therapy|Home-based rehabilitation program for stroke patients aimed at improving the upper extremity motor function. The program is based on musical training, combining self-training sessions of music playing using an app for electronic tablets and music therapy group sessions.
15793115|NCT04507542|Behavioral|Graded Repetitive Arm Supplementary Program|Home-based rehabilitation program for stroke patients aimed at improving the upper extremity motor function. The program comprises self-training sessions of mass repetition of movements and task-specific exercises for the upper extremity.
15793116|NCT04507529|Other|Peer-mentoring|Patients (mentees) are matched with a peer-mentor. Throughout the intervention period (24 weeks), the mentee and the mentor will have informal telephone contact and meet face-to face approximately 8 times during the intervention period.
15793117|NCT04507516|Other|Water-only Fasting|Water-only fasting for at least 10 days followed by 5 days of refeed.
15793118|NCT04507503|Drug|TAS-120|Futibatinib 20mg QD orally on a 28 days cycle
15793119|NCT04507490|Device|Whole body vibration|315/5000 application of whole body vibration with pre-established parameters for each group. All patients will participate in all groups, an interval of at least one week. They will be instructed to climb on the platform and to position a semi knee flexion and remain stationary during the vibration
15793120|NCT04507477|Biological|Rituximab|For EBV seropositive lungs meant for an EBV seronegative recipient, one dose of rituximab (500mg) will be added to the EVLP perfusate and be allowed to circulate for 3-4 hours.
15793192|NCT04506853|Device|MED-EL Cochlear Implant System|Cochlear implant and audio processor
15793193|NCT04506840|Other|Physical activity|Patients will participate in a program of physical exercise. Resistance training, endurance training, balance and flexibility will be trained with the objective to reduce the side effects of chemotherapy and, in order to improve their quality of life
15793194|NCT04506827|Procedure|Maxillary Sinus Augmentation|Biomaterial Graft into the Maxillary Sinus
15793195|NCT04506827|Device|Maxillary Sinus Graft with ABBM|The maxillary sinuses in the control group are grafted with ABBM
15793121|NCT04507464|Behavioral|Ecological Momentary Intervention|Participants will wear a Fitbit that has been programmed to deliver a notification (a buzz) when activity has ceased for more than 10 minutes. They will receive suggestions on their Illumivu mEMA smartphone app on how to replace sitting time with PA such as standing up 5 times or taking 20 steps, or even performing a short (20 seconds) preferred dance routine. Fitbit data will be captured in real-time via the iCardia platform. Participants will receive reminders from their smartphones to enter real-time feedback on activity options selected and how successful they were in adopting the option. These data will allow tracking of underlying preferences for behaviors and to tailor the program accordingly.
15793122|NCT04507451|Procedure|inspiratory and expiratory muscle training|inspiratory muscle training using threshold IMT device expiratory muscle training using a bottle filled of water
15793123|NCT04507451|Procedure|inspiratory and expiratory exercises|inspiratory exercise using fractionated inspirations expiratory exercise using a bottle filled with water at a minimum level
15793126|NCT04507425|Other|Standard of Care - Nasal Cannula|Standard of care. Flexible tube to provide extra oxygen when patients need a little help, but are not in respiratory distress.
15793127|NCT04507425|Other|High-flow nasal cannula|Same as nasal cannula, except the oxygen is heated or humidified and the flow is stronger, pushing air into the lungs to help keep the airway open.
15793128|NCT04507425|Other|HFNC plus non-invasive ventilation|This method uses HFNC as described above and adds noninvasive ventilation which is similar to CPAP machine and uses a mask rather than having to intubate (putting a tube down your throat to keep your airway from collapsing).
15793129|NCT04507412|Drug|dexamethasone|perioperatively 9 mg i.v subministration
15793130|NCT04507399|Behavioral|Liquid Model|"To study the perception of whey beverages using sensory methods (rating drying as well as discrimination tests which is the stronger in drying)
~Measuring mucoadhesion via protein content remaining in saliva following swallowing of whey protein and whey permeate beverages."
15793131|NCT04507386|Behavioral|Take a STAND for health|The Take a STAND for health is a newly developed 4-month goal-setting intervention aimed at reducing sedentary behavior
15793132|NCT04507373|Drug|Simvastatin 40mg|40mg oral daily for 10 weeks
15793133|NCT04507360|Behavioral|Engagement Strategies TBD|Engagement strategies that will be tested in Aim 3 in Y04 will be developed based on learnings from Aims 1 and 2 in Y01-Y03 of the project.
15793134|NCT04507347|Drug|TRC041266|TRC041266 sachet 1500 mg strengths
15793135|NCT04507347|Drug|Placebo|TRC041266 sachet 1500 mg matching placebo
15793136|NCT04507321|Drug|GSK3640254 Oral tablet|GSK3640254 will be available as white film-coated round tablets to be administered via oral route with meal in the morning with 240 milliliter (mL) of water at room temperature.
15793137|NCT04507321|Drug|[14C]-GSK3640254 intravenous infusion|[14C]-GSK3640254 will be available as clear, colorless solution free from visible particulates to be administered via the IV route.
15793138|NCT04507321|Drug|[14C]-GSK3640254 powder|[14C]-GSK3640254 will be available as white powder to be reconstituted into a suspension with 25 mL of vehicle before dosing so as to administer 85 mg dose with meal in the morning.
15793140|NCT04507295|Device|cerebral oximetry ( INVOS 5100 )|"in case of critical cerebra desaturation occurred which is defined as decrease in cerebral saturation by 20% from the base line the following will be done
~Increase FIO2 up to 100%
~Increase PEEP up to 5 cmH2O
~Decrease insufflation pressure"
15793141|NCT04507282|Drug|LMWH|COVID 19 positive patients anticogulation level, subprophylactic level and prophylactic level
15793146|NCT04507243|Device|Active - HD tDCS|Non-invasive neuromodulation using HD electrodes placed on the scalp to deliver a constant, low current at 2 mA.
15793147|NCT04507243|Device|Sham - HD tDCS|Sham neuromodulation using HD electrodes placed on the scalp to deliver a low current ramped up/down for 20 sec.
15793148|NCT04507217|Drug|Tislelizumab, Carboplatin, Pemetrexed|"Tislelizumab: 200mg administered intravenously (IV) on Day 1 of each 21-day cycle
~Carboplatin: AUC 5 administered intravenously (IV) on Day 1 of each 21-day cycle, 4 cycles
~Pemetrexed: 500mg/m2 administered intravenously (IV) on Day 1 of each 21-day cycle"
15793149|NCT04507204|Drug|Adhansia XR|Methylphenidate extended-release capsules taken once daily (25 mg, 35 mg, 45 mg, 55 mg, 70 mg, and 85 mg)
15793150|NCT04507204|Drug|Concerta|An osmotic-controlled oral release delivery system (OROS) of methylphenidate HCl (MPH) extended-release tablets taken once daily (18 mg, 27 mg, 36 mg, and 54 mg)
15793151|NCT04507191|Diagnostic Test|immunohistochemical staining|immunohistochemical staining of programmed death-ligand 1 (PDL1) marker
15793152|NCT04507178|Drug|Nadroparin Injectable Product|high dose LMWH compared to prophylactic dose LMWH
15793153|NCT04507165|Procedure|Paravertebral block+Anterior serratus plane block|"Paravertebral block will be performed at T3 and T7 level on the surgical side using out-of-plane approach under ultrasound-guided, with 0.5% ropivacaine 10ml at each injection site. Anterior serratus plane block will be performed at the 4th rib level on the surgical side under ultrasound-guided, with 0.5% ropivacaine 15ml. The blocking range is measured by ice cube method 15 minutes after the procedure."
15793196|NCT04506827|Device|Maxillary Sinus Graft with TCP|The maxillary sinuses in the test1 group are grafted with TCP
15793197|NCT04506827|Device|Maxillary Sinus Graft with TCP + HA|The maxillary sinuses in the test1 group are grafted with TCP + HA
15793198|NCT04506814|Device|Endocardial PVI|Catheter based PVI
15793154|NCT04507165|Drug|opioid free anesthesia|"Anesthesia induction: Dexmedetomidine 1µg/kg (intravenous infusion within 10min), propofol 1.5-2mg/kg (intravenous bolus), lidocaine 1.5-2mg/kg (intravenous bolus), cisatracurium besylate 0.15-0.3mg/kg (intravenous bolus before tracheal intubation), methylprednisolone 40mg (intravenous bolus), esmolol 1mg/kg (intravenous bolus), and 0.5% tetracaine 5ml for surface anesthesia of the throat.
~Maintenance of anesthesia: Continuous infusion of propofol and dexmedetomidine [0.4μg/(kg.h)]. The infusion rate of propofol was adjusted according to bispectral index value. Cisatracurium besylate was given as needed. Flurbiprofen 50mg was given intravenously before the skin incision and suture respectively.
~Remedy: If blood pressure rises (more than 30% of the mean arterial pressure after induction), and heart rate increases (more than 30% of heart rate after induction) during skin incision, lidocaine 1.5mg/kg will be given intravenously and then be continuously infused at a rate of 1.5mg/(kg.h)."
15793155|NCT04507165|Drug|opioid based anesthesia|"Anesthesia induction: Propofol 1.5-2mg/kg (intravenous bolus), sufentanil 0.3μg/kg (intravenous bolus), cisatracurium besylate 0.15-0.3mg/kg (intravenous bolus before tracheal intubation), methylprednisolone 40mg (intravenous bolus), esmolol 1mg/kg (intravenous bolus).
~Maintenance of anesthesia: Continuous infusion of propofol and remifentanil. The infusion rate of propofol was adjusted according to BIS value. The infusion rate of remifentanil was 0.1-0.5µg/(kg.min) and adjusted according to the change of heart rate and blood pressure. Cisatracurium besylate was given as needed. Sufentanil 0.1μg/kg and flurbiprofen 50mg were given intravenously before the skin incision and suture respectively."
15793156|NCT04507152|Other|Blood flow restriction resistance training|The participants will carry weights and perform certain resistance exercises, such as step-up, sit-to-stand, and tip-toe-standing. The experimental group will execute the training with blood flow restriction.
15793157|NCT04507152|Other|Resistance training|The participants will carry weights and perform certain resistance exercises, such as step-up, sit-to-stand, and tip-toe-standing. The control group will execute the training without blood flow restriction.
15793158|NCT04507126|Biological|Bacillus Calmette-Guerin (BCG)|Vaccine
15793159|NCT04507113|Other|DTI sequence acquisition|DTI sequence acquisition
15793160|NCT04507100|Behavioral|World Health Organization Health Promoting Schools|"Healthy eating: regulation and monitoring of food sold in school cafeterias, healthy eating behavior change campaign, provision of healthy breakfasts.
~Physical activity: hourly active breaks during classes, quality physical education, active recess, and extra-curricular leisure activities and tournaments.
~Healthy hydration: access to water fountains and regular monitoring of water safety, regulation and monitoring of beverages sold in the school, and social marketing campaign promoting drinking plain water.
~Other cross-sectional activities: Referral of children identified as living with underweight, overweight, or obesity, training for school directors, teachers and parents, establishment of school objectives to become a health promoting school, monitoring progress, and publicly acknowledging school progress in becoming a health promoting school."
15793161|NCT04507087|Behavioral|Documentary|A 20-minute documentary about the health, environmental, and animal welfare consequences of eating meat and animal products
15793162|NCT04507087|Behavioral|Control|"A 20-minute unrelated video (a motivational talk entitled Listening to shame)"
15793163|NCT04507074|Device|lumbar traction therapy|The application of traction forces on the traction table (ST6567P-SEERSMEDICAL) will last 30 minutes a day for 4 weeks (continuous traction mode with a maximum strength of 30% of the patient's body weight).
15793164|NCT04507061|Drug|runcaciguat|Titrated dose of active dose 1, dose 2, dose 3, dose 4 of runcaciguat will be administered orally once a day.
15793165|NCT04507061|Other|Placebo|Sham-titrated dose of matching placebo will be administered orally once a day.
15793166|NCT04507048|Other|Active educational intervention|an active educational intervention will be provided in the experimental arm, consisting in the administration of a booklet (passive intervention) + an oral standardized explanation of the booklet given by a trained dermatologist for each center.
15793167|NCT04507048|Other|Passive educational intervention|"Administration of a booklet containing the explanation of 2 clinical rules for early detection of atypical melanocytic lesions: the ABCDE and the ugly duckling rules."
15793168|NCT04507035|Drug|Anlotinib hydrochloride capsules|Using anlotinib of 2 cycles as the first-line therapy.
15793169|NCT04507022|Drug|Estradiol Valerate|2mg three times daily
15793170|NCT04507022|Drug|Progesterone|100 mg daily intramuscular
15793171|NCT04507022|Drug|Aromatase inhibitor|2.5 mg twice daily for 5 days
15793172|NCT04507009|Device|Ozone|topical gaseous ozone application
15793173|NCT04507009|Device|CGF|concentrated growth factor (CGF) application
15793174|NCT04507009|Other|Traditional treatment|Alvogyl application
15793175|NCT04506996|Behavioral|Monday-Focused Tailored Rapid Interactive Mobile Messaging for Weight Management|see arm/group descriptions
15793176|NCT04506996|Behavioral|Monday-Focused Written Messages for Weight Management|see arm/group descriptions
15793177|NCT04506996|Behavioral|Educational Materials|After the baseline assessment and the 1st follow-up (~8 weeks post randomization), participants received educational materials regarding physical activity and healthier diets. The study staff reviewed these materials with the participants
15793178|NCT04506983|Biological|GPC3-CAR-T cells|Patients with hepatocellular carcinoma will be enrolled, and GPC3-CAR-T cells will be intravenously infused with a escalated dose of 1×106 /3×106/10×106GPC3-CAR-T cells.
15793179|NCT04506970|Diagnostic Test|Comprehensive Doppler Ultrasound of the Placenta|Ultrasound measures to be collected include uterine artery (UtA) and umbilical artery (UA), systolic/diastolic (S/D) ratio, resistance index (RI), pulsatility index (PI) and presence of early diastolic notch.
15793180|NCT04506970|Other|Verasonics Ultrasound scanner (ultra-sensitive Doppler imaging)|In addition, a Verasonics ultrasound scanner will be used for ultra-sensitive Doppler imaging. Data will be collected on vessel density, periphery-to-center vessel density ratio (VDR) and microvessel morphology.
15793181|NCT04506957|Device|Pulse CO-Oximetry Hemoglobin measurement transcutaneous|this is an observational Investigation, in which transcutaneous continuous hemoglobin detection using Pulse-CO-Oximetry is compared with co-oximetrically measured Hemoglobin using a blood gas analyzer device
15793182|NCT04506944|Other|No intervention|No specific exposure is explored.
15793183|NCT04506931|Other|SMS Survey|Participants will receive a SMS survey
15793184|NCT04506931|Other|IVR Survey|Participants will receive an IVR survey
15793199|NCT04506814|Device|Epicardial Posterior Wall Isolation + LAA Exclusion + Endocardial PVI|Minimally invasive PVI with posterior wall RF ablation + LAA clip + endocardial PVI
15793200|NCT04506801|Dietary Supplement|Probalans senior|Participants were told to consume 9 drops of study probiotics/placebo once a day for next 12-week intervention.
15793201|NCT04506801|Other|Placebo|Participants were told to consume 9 drops of study placebo one a day for the next 12-week intervention
15793202|NCT04506775|Device|ViTrack|ViTrack is a continuous non-invasive wearable blood pressure cuff.
15793203|NCT04506775|Procedure|Radial artery catheterization|Radial artery catheterization is the standard of care for measuring blood pressure continuously throughout surgery.
15793204|NCT04506762|Procedure|Regional analgesia|Insertion of bilateral ESP catheters
15793205|NCT04506749|Dietary Supplement|Dietary supplement consumption|The consumption time was 56 days. Consumed 100 grams daily to consume during the day.
15793206|NCT04506736|Other|ARM|"The ARM is performed by setting the peak inspiratory pressure to 45 cmH₂O then changing the mode of ventilation to pressure controlled ventilation (PCV) with the inspiratory pressure set to give a tidal volume equal to that given during VCV, I:E ratio of 1:1 and a PEEP of 5 cmH₂O. The PEEP level is then increased in 5 cmH₂O steps every minute till it reaches 20 cmH₂O and inspiratory pressure is increased to get an airway opening pressure (inspiratory pressure + PEEP) of 40 cmH₂O which is maintained for one minute after which the ventilation returned to the original setting except for the PEEP level which is kept at 20 cmH₂O.
~The titration of individualized PEEP is done by decremental reduction of the 20 cmH₂O PEEP level in 2 cmH₂O steps every 2 minutes and measuring static compliance of the respiratory system (CRS) at each step."
15793207|NCT04506736|Other|spontanous ventilation|volume controlled ventilation (7ml/kg tidal volume) with addition of 5 cm H₂O fixed PEEP till the end of the surgery .
15793208|NCT04506723|Procedure|Percutaneous Nephrolithotomy|PCNL will be carried out in accordance with the standards and capabilities of the medical center. After the procedure pathomorphological data of the renal parenchyma will be assessed
15793209|NCT04506723|Procedure|Partial nephrectomy|Partial nephrectomy will be carried out in accordance with the standards and capabilities of the medical center. After the procedure pathomorphological data of the renal parenchyma will be assessed
15793210|NCT04506723|Procedure|Radical nephrectomy|Nephrectomy will be carried out in accordance with the standards and capabilities of the medical center. After the procedure pathomorphological data of the renal parenchyma will be assessed
15793211|NCT04506710|Behavioral|Audio recording of the counseling conversation|The patient will have an audio-recorded counseling conversation. Audio recording will be carried out using a portable recorder ZOOM H2n. The audio recordings of the counseling conversations will be performed by the health workers selected to participate in the study.
15793212|NCT04506697|Procedure|Uroflowmetry|The patient is given a portable uroflowmeter for performing uroflowmetry at home, and the NetHealth app is installed on his smartphone. The patient registers his account in the app. A personal uroflowmeter is paired with the patient's smartphone using the installed app via a Bluetooth connection. The investigator trains the patient how to use the app and how to conduct uroflowmetry at home. The patient within 1 day (24 hours) at home performs uroflowmetry during all urination, including night urination.
15793213|NCT04506684|Device|Investigational RAMware downloaded onto Reveal LINQ device|The study is utilizing an investigational RAMware, either LINQ HF or ALLEVIATE-HF, that will be downloaded onto the subject's market-released Medtronic Reveal LINQ ICM. The investigational RAMware enables the hardware to record and store additional sensor data from which a respiratory rate will be derived.
15793214|NCT04506671|Procedure|Renal biopsy|Renal biopsy will be performed prior to the cryoablation on the basis of the center and according to the current protocols
15793215|NCT04506671|Procedure|Cryoablation|Cryoablation under CT guidance will be performed on the basis of the center and according to the current protocols
15793216|NCT04506671|Procedure|Partial nephrectomy|Partial nephrectomy will be performed on the basis of the center and according to the current protocols
15793217|NCT04506658|Device|high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures.|"Patient in lithotomy position (supine) with return plate at lumbar level.
~Start with high power (within the allowed range) to get a faster hyperthermia and slowly decrease this percentage as the current builds up in the patient's body.
~Patients are undergoing high-frequency radio wave electrotherapy 2 times a week (12 procedures at all)."
15793218|NCT04506658|Device|high-frequency radio wave electrotherapy with a frequency of 448 kHz on the penis structures.|Doctor uses sham sensor to reduce efficiency to zero.
15793219|NCT04506645|Drug|REGN5381|Single dose REGN5381 administered via IV infusion
15793220|NCT04506645|Other|Placebo|Placebo matching single dose REGN 5381 administered via IV infusion
15793221|NCT04506619|Other|No Intervention|This is a non-interventional study.
15793222|NCT04506606|Procedure|Afferent block|Block sensory feedback to evaluate hemodynamic and fatigue consequence of group III/IV muscle afferents
15793223|NCT04506593|Other|no intervention|
15793224|NCT04506580|Procedure|DERMABOND™ PRINEO™(2-octyl Cyanoacrylate Adhesive and Polyester Mesh) vs subcuticular nylon suture|DERMABOND™ PRINEO™(2-octyl Cyanoacrylate Adhesive and Polyester Mesh) and subcuticular nylon suture are applied for each knee
15793225|NCT04506567|Drug|225Ac-J591|-Single cycle of fractionated dose of 225Ac-J591
15793226|NCT04506567|Diagnostic Test|68Ga-PSMA-HBED-CC injection|68Ga-PSMA-HBED-CC before and after treatment
15793227|NCT04506567|Drug|225Ac-J591|-Single dose of 225Ac-J591 every 6 weeks x 4
15793228|NCT04506554|Drug|AMVAC + Nivolumab|Nivolumab 240mg will be administered intravenously for 3 doses - on days 1, 15 and 29. AMVAC will be dosed intravenously every 2 weeks for 3 doses on days 1, 15 and 29 with Neulasta or equivalent. Standard AMVAC dose is as follows: methotrexate 30mg/m2, vinblastine 3mg/m2, doxorubicin 30mg/m2, and cisplatin 70mg/m2.
15793229|NCT04506541|Other|Kangaroo Care|Kangaroo care application started in the first minute after giving birth in mothers who were in the kangaroo care group and came to the delivery room.
15793230|NCT04506515|Diagnostic Test|Psychological stress and adaptation at work score (PSAS)|completing a survey based on PSAS
15793231|NCT04506502|Device|The ZELTIQ System|The MMS device will be used to perform the treatments.
15793232|NCT04506489|Other|Psychological investigation|Psychological tests, psychological interviews.
15793233|NCT04506476|Device|"Fitness tracker based activity training for Arm A and B. Booklet physical training, exercise and cancer and an introduction about physical activity during cancer therapy for Arm A, B, C"|"Patients receive a fitness tracker, a booklet Physical training, exercise and cancer and an in-person briefing about physical activity during cancer therapy. With offered guidelines for the daily step counts patients should improve their physical activity during radiotherapy of breast cancer. A weekly feedback and a new goal for the next week will be provided until the individual patient reaches a daily activity of 6000 steps. The setting will be to maintain to this daily activity of 6000 steps during radiotherapy."
15793240|NCT04506450|Procedure|Peripheral nerve block|"In this group, four nerve blocks will be associated to ensure adequate anesthesia and analgesia during hip surgery.
~Lumbar plexus and sciatic nerve blocks will be performed with a needle connected to an electrical nerve stimulation. The needle will be advanced until contraction of the femoral quadriceps muscle and plantar or dorsal flexion of the foot will be detected respectively. For both, a mixture of mepivacaine and levobupivacaine will be injected.
~Lateral femoral cutaneous nerve block will be performed with the ultrasound technique. After identifying the nerve, a needle will be inserted with an in plane approach and will be injected.
~Lateral branch of iliohypogastric nerve block will be executed with the De Visme approach. Along the iliac crest (range between 7 and 11 cm from the anterior superior iliac spine) a needle will be inserted until bone contact is found. Then a mixture of mepivacaine and levobupivacaine will be injected."
15793241|NCT04506450|Procedure|Spinal anesthesia|"In this group, spinal anesthesia will be performed to ensure anesthesia during surgery, while lumbar plexus block will be performed to ensure postoperative analgesia Spinal anesthesia will be performed with a 25 G needle and 12 mg 0.5% levobupivacaine will be injected.
~Lumbar plexus block will be performed with a needle connected to an electrical nerve stimulation. The needle will be advanced until contraction of the femoral quadriceps muscle will be detected. 20 ml 0.5% levobupivacaine will be injected."
15793242|NCT04506437|Behavioral|Family-based mental health navigation|Family-based navigator intervention combined with mHealth practices to improve mental health treatment initiation and engagement
15793243|NCT04506437|Behavioral|Standard of care engagement practices|Standard of care engagement practices and services-as-usual
15793244|NCT04506424|Other|CT Guided Cochlear Implant Programming|Flat Panel (high resolution) CT scans of the temporal bones, including the inner ears, will be obtained. The research team will use the scans to generate custom cochlear implant (CI) programs for use by the participants.
15793245|NCT04506411|Dietary Supplement|Turmipure GOLD®|TPG: Turmipure GOLD® capsules - 4 capsules once daily- as prescribed
15793246|NCT04506411|Dietary Supplement|Turmeric rhizome PE 95% curcuminoids|STE: Turmeric rhizome PE 95% curcuminoids - 4 capsules once daily- as prescribed
15793247|NCT04506411|Dietary Supplement|Placebo|Placebo: Maltodextrin - 4 capsules once daily- as prescribed
15793248|NCT04506398|Procedure|liver transplant|Liver transplantation for hepatocellular carcinoma has the potential to eliminate both the tumor as well as the underlying cirrhosis and is the ideal treatment for HCC in cirrhotic liver as well as massive HCC in noncirrhotic liver.
15793249|NCT04506398|Diagnostic Test|ctDNA|Circulating Tumor DNA Correlates With Microvascular Invasion and Predicts Tumor Recurrence of Hepatocellular Carcinoma
15793250|NCT04506398|Diagnostic Test|whole exome sequencing|xome sequencing analysis of liver tumors could reveal mutational signatures associated with specific risk factors of recurrence.
15793251|NCT04506385|Dietary Supplement|probiotics|In the first phase: 10 subjects have added in the diet a daily dose of 1 billion of freeze-dried LDD01 probiotics (A arm), 12 individuals are supplemented with a daily dose of 1 billion of the DLBL mix (B arm). In the second phase: 10 individuals are supplemented with a daily low dose of probiotics blend (C arm) and 10 individuals are supplemented with a daily high dose of probiotics blend (D arm).
15793252|NCT04506372|Drug|Perioperative withdrawal of angiotensin converting enzyme inhibitors and angiotenin receptor blockers|Withdrawal from 24 hours before surgery until 24-48 hours after surgery. The ACEI/ARB medication is resumed on the second or third day after surgery, as soon as the clinical condition allows based on judgement by the attending physician.
15793253|NCT04506372|Diagnostic Test|Blood draw|Blood will be drawn to measure creatinin and troponin: once before surgery, on the first and second postoperative day, and within 4-8 weeks after surgery
15793254|NCT04506372|Behavioral|Diary to register drug adherence|To register medication adherence, patients will be asked to fill out their medication intake (of ACEI/ARB) in a diary from a week before surgery until surgery.
15793255|NCT04506372|Behavioral|Quality of life questionnaire|Patients are asked to fill out a quality of life questionnaire (EQ-5D) before surgery and at three months after surgery
15793256|NCT04506372|Behavioral|WHODAS questionnaire|Patients are asked to fill out a questionnaire about disabilities (WHO Disability Assessment Schedule 2.0) before surgery and at three months after surgery
15793257|NCT04506359|Other|Experimental Group|The Ex group is COPSCCP+ UC+ case manager care. In this group, a 6-month intervention providing for each time while subject visit their chest surgeon(s) in the OPD (from the first time before hospital discharge/T1).
15793258|NCT04506346|Diagnostic Test|difficult tracheal intubation|Grade Ⅲ or Ⅳ according to Cormach-Lehane Grading of laryngoscopic view
15793259|NCT04506333|Device|A&D UA-651 Blood Pressure Monitor|Test device to be validated.
15793260|NCT04506333|Device|ADC 740-N Manual Sphygmomanometer|Reference device. Meets or exceeds ANSI/AAMI/ISO 81060-1 as required by ISO/ESH/AAMI standards.
15793261|NCT04506307|Device|The ZELTIQ System|The CoolSculpting machine will be used to perform the treatments.
15793262|NCT04506294|Behavioral|eScreen system|The eScreen system is composed of a child screening component and a parent information component. The child screening component is delivered via a game-like interface and includes assessment of current pain, PTSS, and functional recovery. Children are asked to play the game at least 3x/week. The parent information component consists of text / email messages sent to parents at least weekly that summarize child ratings and include a link to an online dashboard with additional personalized information for parents.
15793264|NCT04506268|Behavioral|Opt-out Recruitment Email|Behaviorally informed, opt-out framed recruitment email
15793265|NCT04506268|Behavioral|Opt-in Recruitment Email|Standard, opt-in framed recruitment email
15793266|NCT04506255|Device|Silicone tape|Medical grade tape with silicone adhesive
15793267|NCT04506242|Drug|SHR-1210|PD-1
15793268|NCT04506242|Drug|Apatinib|VEGFR2
15793269|NCT04506229|Genetic|Whole exome sequencing|MoCA survey to evaluate cognitive function in COVID-19 positive cases with vs without neurological symptoms
15793270|NCT04506216|Other|cohort|"During a regular follow-up visit, the following data will be collected:
~questionnaires on lifestyle, eating custom (SCOFF-F, 5th question of the m-SCOFF) and physical activity (IPAQ)
~bio-electric impedance analysis
~insulin pump and sensor data collection"
15793271|NCT04506203|Diagnostic Test|Air test|Patients will breathe 0.21 < FiO2 < 0.25 during 5 min and have a lung ultrasound perfomed at the end of the 5 min trial.
15793273|NCT04506164|Other|Multicomponent Implementation Strategy|The eScreening MCIS was developed over the past seven years and consists of: 1) eScreening software provision, 2) training, 3) RPIW, and 4) ongoing blended facilitation. The investigators developed our MCIS to address specific eScreening implementation barriers found in the investigators' prior research.
15793274|NCT04506164|Other|eScreening|eScreening is a clinical patient self report system that allows Veterans to complete clinical reminders and other self report screens using a secure connection from any internet connected device.
15793275|NCT04506151|Behavioral|Sleep-Opt|12-week behavioral intervention
15793276|NCT04506151|Behavioral|Healthy Living|Healthy Living
15793277|NCT04506138|Drug|Camrelizumab|Camrelizumab 200mg D1, D22
15793278|NCT04506138|Drug|Paclitaxel for Injection (Albumin Bound)|Paclitaxel for Injection (Albumin Bound) 100mg/m^2 D1, D8, D22, D29
15793279|NCT04506138|Drug|Carboplatin|Carboplatin AUC5 D1, D22
15793280|NCT04506125|Other|Haemoglobin 9.5 g/dL|transfusion of red blood cell concentrate if the haemoglobin level is less than 9,5 g/dL
15793281|NCT04506125|Other|Haemoglobine 7.5g/dL|transfusion of red blood cell concentrate if the haemoglobin level is less than 7,5 g/dL
15793282|NCT04506112|Behavioral|Transdiagnostic Sleep and Circadian Intervention (TranS-C), adapted for cardiac rehabilitation|Participants will complete the TranS-C intervention as adapted for cardiac rehabilitation. TranS-C is a behavioral intervention that is rooted in basic sleep and circadian science and draws from empirically-supported treatments including Cognitive Behavioral Therapy for Insomnia (CBT-I), Interpersonal and Social Rhythm Therapy (IPSRT), chronotherapy, and light therapy. It was designed to promote sleep health across a range of sleep problems. Participants in this group will also continue to receive care as usual, cardiac/sleep-related or otherwise.
15793285|NCT04506086|Drug|Blinatumomab|Subjects will receive blinatumomab continuous IV infusion for a maximum of 4 cycles. Each cycle is 6 weeks in duration consisting of 4 weeks of treatment and 2 weeks of rest.
15793286|NCT04506073|Drug|MSC+placebo|2 infusions of 10 X 10^6 MSC/kg and 1 placebo every 3 months.
15793287|NCT04506073|Drug|MSC|3 infusions of 10 X 10^6 MSC/kg every 3 months.
15793288|NCT04506073|Drug|Placebo|3 infusions of placebo every 3 months. Placebo will be identical to the investigational product but will not contain MSCs.
15793289|NCT04506060|Other|serum withdrawal|Serum of the transplant patient. In the transplanted patient, the search for the BK virus is traditionally carried out during visits in the first year after transplantation.
15793290|NCT04506047|Procedure|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
15793291|NCT04506034|Drug|lidocaine patches|for every port entry site from the three in ports of laparoscope, patients received three lidocaine patches 5% (Lidoderm® , Endo Pharmaceuticals, Chadds Ford, PA). Each patch measured 10 cm × 14 cm and contains (700 mg), was divided into two equal parts, six parts applied two of it around one port entry site that marked before sterilization and just before induction of anesthesia. The patches not changed until removed after return of bowel function or on the maximum at fifth postoperative day.
15793292|NCT04506034|Drug|IV lidocaine|received i.v. lidocaine infusion after induction of anesthesia, 2 mg/min if body weight >70 kg or 1 mg/min if body weight <70 kg.
15793293|NCT04506034|Drug|IV saline infusion|received i.v. saline infusion.
15793294|NCT04506021|Drug|Bicarbonate Ringer's solution|According to the choices of the patients' immediate family members, patients will be divided into Bicarbonate Ringer's Solution. no Intervention.
15793295|NCT04506021|Drug|Other Crystalloid|According to the choices of the patients' immediate family members, patients will be divided into other clinical used crystalloid. no Intervention.
15793296|NCT04506008|Radiation|Hypofractionated Radiotherapy|Treated over the course of 1-2 weeks
15793297|NCT04505995|Drug|Azacitidine and homoharringtonine|Concommitant use of azacitidine and homoharringtonine
15793298|NCT04505982|Other|Data extraction from medical files|Data extraction from medical files
15793340|NCT04505657|Drug|lidocaine|placebo to celecoxib administered orally 2 h before the procedure +10% lidocaine spray 4 puffs during the procedure
15793299|NCT04505969|Other|Questionnaire to assess needs|Two questionnaires have been developed to assess the specific needs of healthcare professionals working with SCD patients and of SCD patients or parents of children with SCD
15793300|NCT04505956|Device|Holmium laser lithotripsy with Moses Technology|Holmium laser energy will be delivered for the ureteroscopic fragmenting of kidney stones. Energy will be generated by the commercial available, FDA approved Lumenis PulseTM P120H laser system and Moses laser fiber. Renal stones will be fragmented using a dusting technique. Moses laser settings will be turned on.
15793301|NCT04505956|Device|Holmium laser lithotripsy without Moses Technology|Holmium laser energy will be delivered for the ureteroscopic fragmenting of kidney stones. Energy will be generated by the commercial available, FDA approved Lumenis PulseTM P120H laser system and Moses laser fiber. Renal stones will be fragmented using a dusting technique. Moses laser settings will be turned off.
15793302|NCT04505943|Drug|Isonicotinic Acid Hydrazide|2 vaginal tablet of isonicotinic acid hydrazide inserted by the study nurse12 hours before IUD insertion.
15793303|NCT04505943|Drug|dinoprostine|2 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the study nurse 3 hours before IUD insertion.
15793304|NCT04505943|Drug|misoprostol|2 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion
15793305|NCT04505930|Behavioral|Interventional HPV vaccination video modules|The study team provide participants in the intervention group with interventional education, using interactive video watch and dynamic discussion. The educational videos were aiming to reinforcement and improvement the awareness, knowledge, attitude, intention and actual uptake of HPV vaccination shots among Chinese parents.
15793306|NCT04505930|Behavioral|General Vaccination Education|Education session conducted using only handouts of vaccinations including HPV
15793307|NCT04505917|Drug|dinoprostol|2 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the study nurse 3 hours before IUD insertion.
15793308|NCT04505917|Drug|misoprostol|2 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion.
15793309|NCT04505917|Drug|placebo|2 tablet of placebo inserted by the study nurse 3 hours before IUD insertion
15793310|NCT04505904|Drug|Syntocinon|Synthetic oxytocin spray, 24 IU per spray.
15793311|NCT04505904|Drug|Placebo|Placebo spray with no active ingredient.
15793312|NCT04505891|Behavioral|Education|Kidney health education will be delivered prior to discharge by trained nurse educators.
15793313|NCT04505891|Behavioral|Education and follow-up|In patients allocated to the education and follow-up arm, education along with a a post-discharge healthcare visit from a multidisciplinary care team will be performed.
15793314|NCT04505878|Drug|Vitamin C|Vitamin C is a first-line antioxidant that directly scavenges free radicals, inhibits reactive oxygen species (ROS) producing enzymes and recovers other cellular antioxidants
15793316|NCT04505852|Device|Embrace|Patients wear Embrace2 to help in seizure reporting and patient care.
15793317|NCT04505839|Drug|STP1002|Oral capsule, QD
15793319|NCT04505813|Biological|NEXI-002 T Cells|The NEXI-001 T cell product will be administered as a single IV infusion to patients within 72 hours after completing LD therapy.
15793320|NCT04505800|Dietary Supplement|Tryptophan supplement|"Pure L-tryptophan in capsules (500mg/capsule)
~3g tryptophan per day (2 capsules, t.i.d.), at 8AM, 4PM, and 0AM (± 1 hour)"
15793321|NCT04505800|Dietary Supplement|Maltose|Maltose
15793322|NCT04505787|Drug|Esflurbiprofen hydrogel patch 165 mg (EFHP)|patch application with PK blood sampling
15793323|NCT04505787|Drug|Froben 100 mg comprimidos revestidos|tablet administration with PK blood sampling
15793327|NCT04505761|Device|Virtual Reality|Participants will use a Virtual Reality headset with a range of applications applicable for rehabilitation after COVID-19. Applications target physical, psychological, and cognitive rehabilitation. VR headset will be used for six weeks first at the physiotherapist's practice, and when possible, at home.
15793328|NCT04505748|Device|Self-transfusion device|The Transfusion filter set for salvaged blood (Summit Medical Ltd, Gloucestershire, UK) has been randomly used in 20 patients postoperatively. Patients, who received autologous blood, transfused with the collected amount of blood, only once, 6h postoperatively
15793329|NCT04505735|Drug|11C-PiB|Pittsburgh Compound-B (11C-PiB) is a diagnostic imaging agent that binds to beta-amyloid plaques and allows them to be viewed using positron emission tomography (PET) imaging.
15793332|NCT04505696|Other|Speech-Language Pathology Presentation|45 minutes presentation on Speech-Language Pathology introduction and scope Introduction to speech and language Introduction to a range of disorders The scope of practice
15793333|NCT04505683|Drug|Benapenem|Benapenem for IV injection administered as a 1-gram IV infusion
15793334|NCT04505683|Drug|Ertapenem|Ertapenem for IV injection administered as a 1-gram IV infusion
15793338|NCT04505657|Drug|celecoxib plus lidocaine|Celecoxib 200 mg (Celebrex® 200, Pﬁzer,USA) administered orally 2 h before the procedure +10% lidocaine spray 4 puffs during the procedure
15793339|NCT04505657|Drug|Celecoxib|Celecoxib 200 mg (Celebrex® 200, Pﬁzer,USA) administered orally 2 h before the procedure +Sterile water 4 puffs during the procedure
15793341|NCT04505644|Drug|lidocaine patch|Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.
15793342|NCT04505644|Drug|IV lidocaine|received i.v. lidocaine infusion after induction of anesthesia, 2 mg/min if body weight >70 kg or 1 mg/min if body weight <70 kg.
15793343|NCT04505644|Drug|IV saline infusion +Sham patch|received i.v. saline infusion +Sham patch containing no study medication applied at 12 hours after cesarean delivery and removed 24 hours after delivery. A second sham patch containing no study medication applied at 36 hours after cesarean delivery and removed at 48 hours after delivery.
15793344|NCT04505618|Device|Swept-Source OCT Angiography|Non-invasive, minimal risk, ocular imaging study
15793345|NCT04505618|Device|Spectral-Domain OCT Angiography|Non-invasive, minimal risk, ocular imaging study
15793346|NCT04505618|Device|Fundus Imaging|Non-invasive, minimal risk, ocular imaging study
15793347|NCT04505618|Device|Axial Length Measurement Device|Non-invasive, minimal risk, ocular imaging study
15793348|NCT04505605|Other|Blood samples|A blood sample will be collected on a dry tube with 5mL separating gel on each enrolled patients. Those will be made depending on the patients hospitalization.
15793349|NCT04505592|Drug|Tenecteplase|First 20 patients randomized to treatment arm will receive 0.25 mg/kg of tenecteplase. Next 20 patients randomized to treatment arm will receive 0.50 mg/kg of tenecteplase. Both will receive concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.
15793350|NCT04505592|Drug|Placebo|Patients will receive placebo with concomitant heparin to maintain activated partial thromboplastin time between 2.0 and 2.5 upper limit of normal.
15793351|NCT04505579|Device|Anterior Vertebral Body Tethering|Anterior Vertebral Body Tethering (AVBT) is a technique that utilizes growth modulation to remodel the shape of the vertebra and straighten scoliotic curves in skeletally immature individuals. In this technique, screws are inserted at each vertebral level for the length of the convex side of the curve. A strong cord is connected through the screw tulip heads and used to initially straighten the curve as each level is fixed with a set screw. Following surgery and during the growth period the spine begins to remodel according to the Hueter-Volkmann Law, bone growth is relatively inhibited in areas of increased pressure (convex or tethered side) and relatively stimulated in areas of decreased pressure or tension (concave side).
15793352|NCT04505566|Drug|Ketorolac 0.45% ophthalmic solution|Ketorolac 0.45% ophthalmic solution 1 drop instilled in both eyes twice daily for 3 years in double-masked fashion.
15793353|NCT04505566|Drug|Placebo - Preservative-free artificial tears|Preservative free artificial tears ophthalmic solution 1 drop instilled in both eyes twice daily for 3 years in double-masked fashion.
15793354|NCT04505566|Other|Aqueous PGE2 and inflammatory cytokines measurements|After topical anesthetic, antibiotic and 5% povidone-iodine application, a 30 gauge needle on a 1 ml tuberculin syringe will be inserted into the anterior chamber and used to collect 0.1 ml of aqueous fluid from each eye. Aqueous PGE2 and Inflammatory cytokines will be measured
15793355|NCT04505553|Procedure|Acupuncture Therapy|Undergo acupuncture
15793356|NCT04505553|Procedure|Acupressure Therapy|Undergo acupressure
15793357|NCT04505553|Procedure|Oral Cryotherapy|Undergo oral cryotherapy
15793358|NCT04505553|Other|Questionnaire Administration|Ancillary studies
15793359|NCT04505553|Other|Quality-of-Life Assessment|Ancillary studies
15793360|NCT04505540|Other|Bridge Clinic|Specialized addiction bridge clinic
15793361|NCT04505540|Other|Local Waivered Physician|Direct referral to local waivered physician
15793362|NCT04505527|Behavioral|Lateral stepping|Subjects will step laterally, changing direction every 10 m, thus alternating lead and lag limbs.
15793363|NCT04505527|Behavioral|Forward walking|Subjects will have a typical forward walking
15793364|NCT04505514|Drug|Iron Isomaltoside 1000|"single dose of 1000 mg iron isomaltoside diluted in 100 ml of 0.9% sodium chloride, infused intravenously over ≥ 20 minutes.
~- infusion set will be covered for blinding"
15793365|NCT04505514|Drug|Placebo|"100 ml of 0.9% sodium chloride, infused intravenously over ≥ 20 minutes.
~- infusion set will be covered for blinding"
15793366|NCT04505514|Drug|Iberet-Folic-500|once a day dose, to start 5 days after the intervention
15793367|NCT04505501|Drug|N-803|N-803 is a novel IL-15 superagonist complex that enhances NK cell and CD8+ T-cell proliferation and activation.
15793368|NCT04505488|Behavioral|ASD Screening Parent ENgagement Intervention Program (ASPEN)|The ASPEN intervention is based on naturalistic developmental behavioral intervention strategies to support the development of social communication and play skills and reduce challenging behavior.
15793369|NCT04505475|Procedure|Oral surgical procedure followed by local hemostatic measures (insertion of gelatine sponge and wound suturing)|single and multiple teeth extraction, surgical tooth extraction, third molar surgery, gingivectomy, soft-tissue biopsy
15793370|NCT04505462|Other|Therapeutic diet|A special healthy diet for dialysis patients
15793371|NCT04505449|Diagnostic Test|Left heart catheterization|Patients who underwent left heart catheterization
15793372|NCT04505436|Drug|HM15211|A sterile solution of HM15211 contained in pre-filled syringes
15793373|NCT04505436|Drug|Placebo of HM15211|A sterile, matching solution in pre-filled syringes
15793374|NCT04505423|Procedure|Blind CSF Drain Placement|CSF Drain placement without fluoroscopic image guidance.
15793375|NCT04505423|Procedure|Fluoroscopy-guided Drain Placement|CSF Drain placement utilizing fluoroscopic image guidance.
15793376|NCT04505410|Drug|Tofacitinib|10mg tofacitinib tablets taken twice daily for eight weeks
15793377|NCT04505410|Other|Fast Mimicking Diet|FMD is a five day meal plan that includes foods such as soups, snacks, bards, teas and supplements (omega-3 fatty acids) for a total of 66 items per box. The diet is plant-based, gluten free and dairy free without any artificial preservatives, chemicals or biologically active ingredients.
15793378|NCT04505397|Drug|SKL24741|There will be a single dose escalation to analyze safety and tolerability. Once a dose is selected based on data from the single dose, a gender effect and food effect cohort will enroll followed by a multiple ascending dose escalation study.
15793379|NCT04505397|Drug|Placebo|Sugar pill manufactured to mimic SKL24741
15793380|NCT04505384|Procedure|left bundle branch pacing|left bundle branch pacing
15793381|NCT04505384|Procedure|biventricular pacing|biventricular pacing
15793382|NCT04505371|Behavioral|Wellness Intervention for Smokers with HIV|"WISH is delivered remotely by mobile phone (voice and text message). WISH addresses both smoking and a number of other personally relevant health behaviors (such as treatment engagement, medication adherence, stress and mood management, social support, alcohol use, etc.), making it relevant and engaging to all, not just those ready to stop smoking. For those not yet ready to quit, WISH is designed to build and strengthen motivation and self-confidence for quitting, while smokers also work on other personal health goals.
~Once ready to quit smoking, participants receive evidence-based cognitive-behavioral counseling and encouragement to access nicotine replacement therapy (NRT) or other appropriate pharmacotherapy through usual care VA procedures. Medications will not be prescribed or dispensed by the study."
15793383|NCT04505358|Drug|PU-AD|active vs placebo
15793384|NCT04505358|Drug|Placebo|active vs placebo
15793385|NCT04505345|Behavioral|Cognitive training using the Systemic Lisbon Battery|The Systemic Lisbon Battery comprises exercises for cognitive rehabilitation developed to describe diverse activities of daily living.
15793386|NCT04505345|Behavioral|Treatment-as-usual|Treatment as usual for alcohol use disorder from Casa de Saúde do Telhal is delivered according to the Minnesota Model.
15793387|NCT04505332|Procedure|arthroplasty|back pain in orthopedists due to working actively and performing arthroplasty every day
15793388|NCT04505319|Device|DEFINISSE CORE FILLER|"DEFINISSE CORE FILLER volume will be injected between 4.0 of 5.0 ml on the whole face (at the discretion of the treating physician to achieve an optimal aesthetic result).
~A touch-up will be possible at the first follow-up visit (after one month) with a amount of product between 4.0 and 5.0 ml on the whole face"
15793389|NCT04505306|Procedure|Macular Laser|All treatments were performed using SPCW EndPoint 30% and 50% protocols and STMP laser. Patients in the STMP group were treated with the 810-nm diode micropulse scanning laser TxCell™ (IRIDEX Corporation, Mountain View, CA, USA) at 15% duty cycle. Laser was applied in the confluent mode (low intensity/high density) to cover the entire area of the macular edema and leakage as imaged by OCT and/or fundus fluorescein angiography. Patients in the SPCW group were treated with grid pattern laser with 20ms pulse PASCAL laser 532nm (TopCon Medical Laser Systems, Tokyo, Japan) with EndPoint algorithm, which was either 30% or 50% of testing burn with one burn width apart. In both groups, subthreshold power was determined by titrating burn to light (barely visible) burn and switching to either micropulse mode with 15% duty cycle or 30% and 50% EndPoint value.
15793390|NCT04505293|Device|InfraScanner 2000™|The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention.
15793391|NCT04505280|Drug|Lidocaine 1% Injectable Solution|Greater occipital nerve and cervical region injections once a week for 4 weeks
15793392|NCT04505280|Drug|Saline|0.9% saline Greater occipital nerve and cervical region injections once a week for 4 weeks
15793393|NCT04505267|Other|Hafnium Oxide-containing Nanoparticles NBTXR3|Given IT or intranodally
15793394|NCT04505267|Radiation|Radiation Therapy|Undergo RT
15793395|NCT04505254|Drug|Acalabrutinib|Given PO
15793396|NCT04505254|Biological|Obinutuzumab|Given IV
15793397|NCT04505241|Behavioral|Remotely-delivered physical activity promotion|Over video-call, participants will receive educational content on safely increasing their levels of physical activity (e.g., selecting an appropriate form of exercise, minimizing health risks, the importance of planning), will receive daily text messages (see arm descriptions) for six weeks and complete a 10-15 minute check-in call at the 3-week point of the intervention to assess compliance with daily step goals as well as to help problem-solve barriers to compliance.
15793398|NCT04505228|Drug|Safflower (Carthamus Tinctorius) IgG4 &#X7C; Serum &#X7C; Allergy|The designed Chinese herb formulas
15793399|NCT04505228|Drug|Atropine Sulfate|The basic treatment for heart disease
15793400|NCT04505215|Other|Mulligan Technique|"First, the painless application angle was determined for each patient. The lateral condyle of the humerus was fixed by the web range of the physiotherapist. The elbow joint was glided until the elbow joint and the hand tightening position were not able to cause pain.
~The patients were asked to repeat the motion of the elbow joint and the ball squeezing motion given to their hands 10 times without pain. For pain control, the same procedure was performed with three sets, each containing 10 repetitions of the exercise. The interval between sets was 15 to 20 seconds, and the interval between repetitions within each set was 30 seconds."
15793401|NCT04505215|Other|Muscle Energy Technique|Firstly, 5-7 sec opposite isometric muscle contraction was requested from the patient in the barrier by passively stretching by the physiotherapist until the barrier of the related muscle or dysfunctional joint. After a short rest period of 2-3 seconds, the physiotherapist continued to stretch passively until the second barrier. The application continued until the tension of the muscle or dysfunction of the joint disappeared.
15793402|NCT04505215|Other|Only Exercise (Control)|Eccentric training for the extensor Carpi Radialis Brevis (ECRB) muscle, the most affected wrist extensor tendon, and static stretching exercise for the EKRB muscle were given as home exercise program. The best stretching position for the EKRB tendon is provided when the elbow joint is in extension, forearm pronation, when the wrist is flexed with ulnar deviation (Mills maneuver). Each exercise was taught to patients in 10 repetitions and 10 seconds, and one day of the week, participants in the control group performed their exercises under the supervision of a physiotherapist.
15793403|NCT04505202|Drug|0.12% chlorhexidine gluconate|The patients included in the experimental group (0.12% chlorhexidine gluconate) will receive 3 times daily oral care
15793404|NCT04505202|Drug|Placebo|The patients included in the placebo group ( sodium bicarbonate) will receive 3 times daily oral care
15793405|NCT04505189|Drug|Psilocybin|Psilocybin assisted psychotherapy
15793406|NCT04505163|Procedure|Standard Cryoballoon Pulmonary Vein Isolation (PVI)|Arctic Front Advance cryoballoon ablation system to ablate the pulmonary veins to achieve PVI alone
15793407|NCT04505163|Device|Cryoballoon PVI + Posterior Wall Isolation|Arctic Front Advance Cardiac Cryoballoon Ablation System to ablate the pulmonary veins and the left atrial posterior wall to achieve PVI + posterior wall isolation within the region of the pulmonary venous component
15793432|NCT04504968|Other|Usual care group|The level of usual health care that a patient with diabetes receives from their local national health system
15793433|NCT04504955|Other|Observational Non-Interventional Registry|Observational Non-Interventional Registry
15793434|NCT04504942|Drug|Leronlimab|Drug: Leronlimab 525mg
15793408|NCT04505150|Behavioral|Lifestyle changes, e.g., take part in regular exercise, quitting smoking, and reduce salt consumption|Intervention participants will receive ongoing counselling with evidence-based information with pictures, fact sheets, published literature about the harmful effect of smoking on hypertension and other cardiovascular diseases for the cessation of smoking and to take part in regular exercise.
15793409|NCT04505137|Drug|GMA301 Injection|GMA301 Injection administered as a single dose of 1500 mg
15793410|NCT04505137|Other|GMA301 Placebo Injection|GMA301 Injection without GMA301 administered as a single intravenous dose
15793411|NCT04505137|Drug|GMA301 Injection|GMA301 Injection administered as a single dose of 2000 mg
15793412|NCT04505124|Behavioral|FutureMe App|The FutureMe app provides visual and consequential feedback through a future-self avatar, meaning that the avatar changes its body shape and some additional characteristics based on the participants' activity and food purchasing behaviors. The app tracks participants physical activity behavior (steps) by means of their smartphone (integration to GoogleFit and AppleHealth) and motivates them to increase their step counts. The app also connects to participants' grocery loyalty cards to evaluate their food shopping behavior leveraging the Nutri-score concept. The app motivates participants to improve their food purchases through concrete shopping tips provided in-app.
15793413|NCT04505124|Behavioral|Conventional TrackingApp|The Control Conventional Tracking app provides numeric and factual feedback through conventional data-dashboards. The app tracks participants physical activity behavior (steps) by means of their smartphone (integration to GoogleFit and AppleHealth) and motivates them to increase their step counts. The app also connects to participants' grocery loyalty cards to evaluate their food shopping behavior leveraging the Nutri-score concept. The app motivates participants to improve their food purchases through concrete shopping tips provided in-app.
15793414|NCT04505111|Other|Prehabilitation Program + Enhanced Recovery After Surgery|Prehabilitation Program (nutrition + exercise + psychological counseling) + ERAS protocol
15793415|NCT04505111|Other|Enhanced Recovery After Surgery|ERAS protocol
15793416|NCT04505098|Drug|Icosapent ethyl|2 g by mouth twice daily for at least 6 months
15793417|NCT04505085|Behavioral|Active Dads Healthy Families: Outdoor Education|The intervention will include outdoor education and physical activity opportunities at various outdoor parks. The program will be held one day a week for eight consecutive weeks. Parks and Recreation will facilitate and run the program. Each session will last 60 minutes and include a brief educational discussion and opportunities for various games and activities. Each session will have a special theme relevant to the outdoors. Families will also receive a home toolbox to facilitate activity and learning outside of the program. Feedback on physical activity will be provided at the beginning and the end of the program.
15793418|NCT04505085|Behavioral|Active Dads Healthy Families: Fitness|The intervention will include physical activity opportunities at a community center. The program will be held one day a week for eight consecutive weeks. Parks and Recreation will facilitate and run the program. Each session will last 60 minutes and include a brief educational discussion and opportunities for various games and activities. Families will also receive a home toolbox to facilitate activity outside of the program. Feedback on physical activity will be provided at the beginning and the end of the program.
15793419|NCT04505085|Behavioral|Active Dads Healthy Families: Fitness + Parenting|The intervention will include physical activity opportunities and social support for fathers at a community center. The program will be held one day a week for eight consecutive weeks. Parks and Recreation will facilitate and run the program. Each session will last 60 minutes and include a brief educational discussion and opportunities for various games and activities. Families will also receive a home toolbox to facilitate activity outside of the program. Feedback on physical activity will be provided at the beginning and the end of the program.
15793420|NCT04505072|Behavioral|PR-ESSENCE|Manual-based training of mutual problem-solving
15793421|NCT04505072|Behavioral|Treatment as usual|General support in daily structure and activities that is given to all youth staying at the treatment homes
15793422|NCT04505059|Procedure|Precision cardiac anesthesia|Aperi-operative anesthetic management through target-controlled infusion to accurately control the patient blood concentration, with combination of bispectral index and neuromuscular monitoring to adjust the dosage of general anesthetics.
15793423|NCT04505059|Procedure|Conventional cardiac anesthesia|The anesthesia strategy is mainly depending on the anesthesiologist's clinical experience
15793424|NCT04505033|Drug|HB0017|HB0017 at 100 mg/mL (1 mL/vial) in 2 mL glass vial with a rubber stopper. HB0017 will be administered in the abdominal area by a subcutaneous injection in the mornings. A maximum volume of 1 mL is injected per site.
15793425|NCT04505033|Drug|placebo|A matching injection solution containing a specific volume of normal saline (0.9%, Sodium Chloride Injection USP) and no active substance will be prepared for the subjects who will be assigned to placebo according to the dose schedule.
15793426|NCT04505020|Other|3D Print + Conventional imaging|This group will have a 3D reconstruction of their hip printed using a 3D printer so that the PI can use it in their pre and intra-operative planning along with traditional imaging.
15793427|NCT04505020|Other|Conventional imaging|This group will have CT, MRI and X-Ray imaging completed so that the PI can use it in their pre and intra-operative planning.
15793428|NCT04505007|Other|Specialized heart function clinic|This information has already been provided.
15793429|NCT04504994|Behavioral|inclusion condition|cyberball game: ex- versus over-inclusion condition
15793430|NCT04504981|Behavioral|Y2Prevent|Y2Prevent (Y2P) is a groupl level intervention that consists of 7 weekly group sessions focused on helping young African American men who have sex with men (AAYMSM) identify life goals and safeguard their health to achieve those goals
15793431|NCT04504968|Other|Multimodal intervention|"Optimal control: HbA1c between 7.6-8.5% (60-69 mmol/mol) and Blood Pressure<150/90 mmHg
~The physical exercise program that will be used will be the Vivifrail program (Erasmus + UE). Vivifrail includes: Strength for arms and legs, balance and gait, flexibility and resistance. The duration will be 16 weeks. (3 weeks to explain the program in the Trial site and the rest of weeks, it will be carried out at home).
~Nutritional and educational program to increase diabetes knowledge, develop practical self-care skills for diabetes and increase the likelihood of improving glycemic control safely. The intervention aims to minimize the risk of hypoglycemia, ensure optimal nutritional status and help to maintain functional status. Seven separate sessions of 45 minutes each one twice a week for a period of 3-4 weeks in small groups. They will be moderated by a physician or diabetes educator and focused on behavioral changes and key points."
15793436|NCT04504929|Device|Dynamic tape|Use dynamic type on the pitching shoulder for supporting internal rotation
15793437|NCT04504916|Drug|Zilovertamab vedotin|Intravenous infusion of 2.5 mg/kg
15793438|NCT04504903|Behavioral|Cognitive Behavioral Therapy For Work Success (CBTw)|Veterans will go to 12 weekly group sessions and will learn healthy thinking about work, positive behavioral coping related to work, and will form a work success plan based on their work goals.
15793439|NCT04504903|Behavioral|Psychoeducation|Veterans will go to 12 weekly group sessions and will learn more information about their mental health conditions. Psychoeducation modules are from the Illness Management and Recovery program.
15793440|NCT04504890|Device|EYE-SYNC|Nystagmograph used to measure eye movement
15793441|NCT04504877|Drug|Cannabidiol|Cannabidiol 300 mg daily for 4 weeks
15793442|NCT04504864|Drug|low-dose aspirin|50mg aspirin is used to prevent recurrent stroke.
15793443|NCT04504864|Drug|conventional-does aspirin|100mg aspirin is used to prevent recurrent stroke.
15793444|NCT04504851|Drug|Rosuvastatin 10mg|10mg of Rosuvastatin in the Intensive Phase of Therapy (8 weeks)
15793445|NCT04504851|Drug|Rifampicin|Rifampicin 10mg/kg
15793446|NCT04504851|Drug|Isoniazid|Isoniazid 5mg/kg
15793447|NCT04504851|Drug|Pyrazinamide|Pyrazinamide 25mg/kg
15793448|NCT04504851|Drug|Ethambutol|Ethambutol 15mg/kg
15793449|NCT04504825|Drug|CAEL-101|The investigational product, CAEL-101, is formulated as a sterile liquid solution of protein plus excipients for dilution in a single-use, stoppered, glass vial. Each 10 mL vial contains 300 mg of CAEL-101 at a concentration of 30 mg/mL. CAEL-101 will be diluted with commercially available 0.9% Normal Saline.
15793450|NCT04504825|Other|Placebo|Commercially available 0.9% Normal Saline will be used as the placebo.
15793451|NCT04504825|Drug|cyclophosphamide, bortezomib, and Dexamethasone (CyBorD) regimen|According to institutional standard of care.
15793452|NCT04504812|Drug|Duloxetine|Duloxetine is a drug that is used to improve pain and function in people with knee osteoarthritis (KOA). Duloxetine is approved by the Food and Drug Administration (FDA) for the treatment of depression, anxiety disorder, fibromyalgia, and joint pain. It will be titrated up from 20 or 30mg according to a schedule provided by a study provider.
15793453|NCT04504812|Combination Product|Intra-Articular Injection|Intra-Articular Injection is an injection of 3-6 milliliter (mL) hyaluronic acid (HA) mixed with 1mL depo methylprednisolone (a steroid) and 2mL 0.5% bupivacaine (an anesthetic) into the knee.
15793454|NCT04504812|Procedure|Nerve Procedure with long acting blocks|People assigned to receive this will have 1mL of a long-acting local anesthetic (a.k.a. liposomal bupivacaine or EXPAREL) and steroid injected into the knee.
15793455|NCT04504812|Procedure|Nerve Procedure with nerve ablation|People assigned to receive this will have heat applied to destroy the nerve signaling pain in the knee. Steroid will be administered after the procedure to reduce the risk of neuritis.
15793456|NCT04504812|Behavioral|Pain Coping Skills Training|Participants will be provided with a written manual that includes login information for the pain coping skills training website. They will be expected to log into the system weekly, work through the modules, and participate in skills practice. This intervention will be conducted in combination with best practices and duloxetine.
15793457|NCT04504812|Other|Best Practices|Best Practice includes treatments that experts recommend for knee arthritis pain. Best Practice can include topical or oral pain relievers, a structured exercise program, and weight management if BMI is over 30. Other non-invasive treatments such as acupuncture and yoga are also included.
15793458|NCT04504799|Device|Body composition measurement with HAG-BIA scale|Bio-impendance analysis
15793459|NCT04504786|Other|Vitality acupunch (VA) exercise program|The VA had three phases and took 40 minutes to complete.
15793460|NCT04504786|Other|Control|Participants maintained their daily activities.
15793461|NCT04504773|Behavioral|Virtual Reality Exposure Therapy|Participants will receive a single session of virtual reality exposure therapy that targets the participant's specific phobia stimuli.
15793462|NCT04504760|Drug|ONO-2910|Single ascending dose of ONO-2910 will be administered orally.
15793463|NCT04504760|Drug|Placebo|Single dose of placebo will be administered orally.
15793464|NCT04504760|Drug|ONO-2910|Multiple ascending dose of ONO-2910 will be administered orally.
15793465|NCT04504760|Drug|Placebo|Multiple dose of placebo will be administered orally.
15793466|NCT04504747|Other|molecular analysis of blood and tumor|RNAseq, DNAseq, CTCs
15793467|NCT04504734|Drug|Bucillamine|100mg tablets
15793468|NCT04504734|Drug|Placebo|100mg tablets
15793469|NCT04504734|Drug|Bucillamine|200mg tablets
15793470|NCT04504721|Other|light therapy|The intervention will take 8 weeks with 30 minutes exposure at awakening to blue-enriched white light.
15793471|NCT04504708|Drug|ZX-101A|Once daily, oral dosing of ZX-101A at the assigned dose level for 28 consecutive days in a 28-day cycle
15793472|NCT04504682|Behavioral|Ambulation|Patients will be encouraged to ambulate for 20 minutes of every hour.
15793475|NCT04504656|Other|observation of postoperative leak, stenosis, mortality|detect complications in both groups
15793476|NCT04504643|Other|Technology-assisted circuit training|Circuit training assisted by Fitlight™ 3 times a week for one hour during 8 weeks
15793477|NCT04504643|Other|Conventional circuit training|Conventional circuit training including single and dual task 3 times a week for one hour during 8 weeks
15793478|NCT04504643|Other|Nordic walking|Classic nordic walking 3 times a week for one hour during 8 weeks
15793479|NCT04504630|Device|High Definition Transcranial Direct Current Stimulation|This wireless device delivers a very low electrical current to focused regions on the scalp in order to modulate underlying brain circuits to promote neuroplasticity. The device will be fitted onto a neoprene EEG cap, with 1 anode electrode placed and surrounded by 4 cathode electrodes in a ring pattern. Electrical stimulation will be applied using a constant voltage cortical stimulator (Model D185, Digitimer Ltd, UK, maximal output 1000 V/1.5 A) with single square-wave 50-μs pulses (0.1 A/μs rise time).
15793480|NCT04504630|Device|Sham HD-tDCS|Sham HD-tDCS
15793481|NCT04504617|Behavioral|Nutrition education intervention to enhance complementary feeding practices|The intervention consist of a six-week nutrition education intervention developed following the DESIGN procedure and the Socio-Cognitive Theory. The intervention consisted of six three-hour weekly sessions that covered topics such as 1) importance and benefits of exclusive and continuing breastfeeding; 2) nutrition for lactating mothers; 3) importance and benefits of complementary feeding practices; 4) risks for starting complementary feeding too early or too late; 5) complementary feeding practices for each age group (6-8, 9-11, and 12-24); 6) importance and benefits of dietary diversity; 7) importance of animal-source foods; 8) importance and benefits of following water, sanitation, and hygiene practices; 9) food safety practices when preparing meals; and 10) the recommended hand-washing protocol. Each lesson was designed to provide a lecture, a discussion using counseling cards, a cooking demonstration with tasting session, and key messages.
15793482|NCT04504604|Diagnostic Test|FoundationOne CDx and FoundationOne Liquid CDx|Eligible patients will have Foundation Medicine blood and tissue testing and have their results reviewed by the study's Virtual Molecular Tumor Board which, in turn, will make recommendations for treatment to treating physicians.
15793483|NCT04504578|Procedure|contact lens assisted corneal cross linking|40 eyes of 30 patients underwent CACXL. The central 9 mm of corneal epithelium was abraded , Iso-tonic riboflavin 0.1% was applied every 2 minutes for 10 minutes on the debrided cornea. A disposable soft Contact lens without an ultraviolet filter (Soflens, Bausch & Lomb) was placed in the inferior fornix during soaking of the stroma with riboflavin for 10 minutes. The contact lens was applied on the corneal surface and the cornea was exposed to ultraviolet-A irradiation at fluence of 3.0 mW/cm2 for 30 minutes The uncorrected (UDVA) and best corrected (BDVA) visual acuity, and maximum (K max) keratometric values, were assessed before, and after 9 months CXL. Endothelial cell count was assessed before and 3 months after CXL. Anterior segment OCT was done 1 month after CXL to evaluate the presence and depth of the corneal stromal demarcation line.
15793484|NCT04504565|Diagnostic Test|99mTc-3PRGD2|intravenous injection of 0.3 mCi/kg of 99mTc-3PRGD2
15793485|NCT04504552|Drug|Avelumab|Subjects will receive treatment with avelumab monotherapy 800 mg as a 60-minute IV infusion on the Day 1 (± 2 days) of a 2-week treatment cycle for 4 administrations.
15793486|NCT04504539|Biological|mOPV|mOPV (monovalent oral polio vaccine) is an oral polio vaccines which consists of only attenuated virus of serotypes 1
15793487|NCT04504539|Biological|bOPV|bOPV (bivalent oral polio vaccine) is an oral polio vaccines which consists of attenuated virus of serotypes 1and 3
15793488|NCT04504539|Biological|Full dose IPV|FIPV (full dose injectable polio vaccine)
15793489|NCT04504539|Biological|fractional IPV|fIPV (fractional dose injectable polio vaccine)
15793490|NCT04504526|Drug|68Ga-Pentixafor|Intravenous injection of one dose of 74-148 MBq (2-4 mCi) 68Ga-Pentixafor. Tracer doses of 68Ga- Pentixafor will be used to image lesions by PET/CT.
15793491|NCT04504513|Drug|Trilaciclib|"Trilaciclib is a highly potent, selective, and reversible cyclin-dependent kinase 4/6 inhibitor administered intravenously prior to chemotherapy for chemotherapy-induced myelosuppression (CIM).
~In patients being treated for SCLC, trilaciclib transiently maintains G1 cell cycle arrest of hematopoietic stem and progenitor cells (HSPCs) in the bone marrow, thus protecting the cells from damage by cytotoxic chemotherapy (myelopreservation). This can reduce chemotherapy-related toxicity, making chemotherapy safer and more tolerable, and also reduce the need for rescue interventions that address the effects of myelosuppression, such as growth factors or blood and platelet transfusions."
15793492|NCT04504500|Behavioral|HSOG guidelines application|In their practice, as regards the mode of delivery, obstetricians are encouraged to conform to the three guidelines and two consent forms published by the Hellenic Society of Obstetrics and Gynecology (HSOG). The members of the appointed Steering Committee and/or local opinion leaders will discuss and disseminate these guidelines among the professional staff in the respective maternity units, providing them with the opportunity to identify specific barriers, overcome them, and develop an implementation timetable.
15793493|NCT04504500|Behavioral|Interactive workshops and courses|The workshops and courses will give instruction in indications for cesarean section and clinical scenarios, physiology-based cardiotocography (CTG) interpretation, obstetric emergencies (with topics including breech delivery, trial of labor after cesarean, delivery of twins, induction and augmentation of labor), organization of the labor ward, as well as launching of regular cesarean section and CTG meetings with review of the patient notes. The workshops will last four days and will be conducted by experienced trainers. The expectation is that the obstetricians will gain very considerable knowledge and skills, which will enable them to subsequently follow these practices safely and competently.
15793494|NCT04504500|Behavioral|Feedback through follow-up meetings|Regular follow-up meetings with members of the steering committee and local opinion leaders throughout the intervention period will enhance compliance with the guidelines. Feedback with positive phrasing will be incorporated to meet local needs.
15793495|NCT04504500|Behavioral|Robson criteria usage|Obstetricians are set to a routine to enable them to use the Robson 10-group classification criteria for cesarean sections and obtain feedback on the unit's cesarean section rates monthly. They thus know which category is higher and can be reduced further.
15793496|NCT04504500|Behavioral|Access to live real-time statistics|Live real-time statistics provided by an online platform, on a regular basis, is expected to improve adherence, through regular feedback. Each unit will see other units' statistics by means of an anonymous reporting system. This repetition will create silent signals that will remind the participating obstetricians to remain on task.
15793497|NCT04504500|Behavioral|Attendance of local cesarean section meetings|Local cesarean section meetings will be held weekly, in each unit. The members of the steering committee or local opinion leaders may actively participate in these meetings. Local obstetricians learn to judiciously adapt standard medical practices, thereby avoiding unnecessary medical interventions. This is a way to further enhance compliance, as during the discussions the behavior expected of the obstetricians is clearly stated by the participating opinion leaders.
15793498|NCT04504500|Behavioral|Attendance of local CTG interpretation meetings|"Local CTG interpretation meetings will be held weekly, in each unit, during which all abnormal CTG cases that led to cesarean section will be reviewed and discussed. Members of the Steering Committee or local opinion leaders may actively participate in these meetings. Obstetricians are encouraged to reflect on their medical practice through judicious physiology-based CTG interpretation."
15793915|NCT04501432|Other|No intervention|This study does not include an intervention
15793499|NCT04504500|Behavioral|Reminders of proper clinical practice|Effective and reliable reminders concerning optimal obstetric practice will be placed in labor wards, staff rooms, patient notes, vaginal birth packages and above theater hand washers. There will be short messages with positive phrasing regarding the benefits of vaginal birth, thus reminding birth attendants to reduce unnecessary cesarean sections. Relevant SMS (short message service) will be sent to the participating obstetricians' mobiles on a regular basis, so as to motivate them via non-verbal signals.
15793500|NCT04504500|Other|HSOG guidelines implementation|There will be application in daily practice of three guidelines and two consent forms pertaining to the mode of delivery published by HSOG. Obstetricians are informed on evidence-based medicine in obstetrics and provided with a structured and safe approach to labor management. The members of the appointed Steering Committee and/or local opinion leaders discuss and disseminate the guidelines among the professional staff at the respective maternity units, answer questions, and make available their knowledge and experience. Adoption of guidelines by the participating unit helps to establish clear, consistent rules that are direct and simple, and obstetricians are asked to embrace fully justified medical practice.
15793501|NCT04504500|Other|Interactive workshops and courses training|The workshops and courses will provide instruction in indications for cesarean section and case scenarios, physiology-based CTG interpretation, obstetric emergencies (with topics including breech delivery, trial of labor after cesarean, delivery of twins, induction and augmentation of labor), organization of labor ward and launching of cesarean section and CTG meetings. This type of formal training provides problem-solving strategies, using mnemonics, that are critical in emergencies and that also aid in learning and retaining the skills being taught. Functional and social skills that directly affect decision-making and effectiveness are addressed. Thus, units adopt a continuous educational procedure for their staff, enhancing their confidence when dealing with labor emergencies and redesigning labor management plans, so as to ensure high-level obstetric services.
15793502|NCT04504500|Other|Implementation of Robson criteria classification|Use will be implemented of an online application embedded in the REDCap electronic database questionnaire with Robson 10-group classification criteria and feedback on the unit's cesarean section rates monthly, so as to know which category is higher and can be reduced further. This change in the unit's practice will introduce a new medical reporting and audit system that can detect unjustified medical procedures much more easily.
15793503|NCT04504500|Other|Live real-time statistics online platform|Live real-time statistics provided on a regular basis by an online platform will provide feedback and essential information. Each unit will see other units' statistics using an anonymous reporting system. This information can trigger self-generative learning strategies and help obstetricians to become more effective learners.
15793504|NCT04504500|Other|Local cesarean section meetings|Local cesarean section meetings will be held weekly in each unit. The members of the Steering Committee or local opinion leaders may actively participate in these meetings. The unit's staff can hear about both justified and unnecessary surgical procedures and draw informed conclusions as to the optimal procedure in similar cases. They will also have the opportunity to actively participate in an elaborative problem-solving discussion. These meetings when routinely conducted, provide feedback and audit resources to help improve performance and further enhance compliance.
15793505|NCT04504500|Other|Local CTG interpretation meetings|"Local CTG interpretation meetings will be held weekly, in each unit during which all abnormal CTG cases that led to cesarean section will be reviewed and discussed. Members of the Steering Committee or local opinion leaders may actively participate in these meetings offering coaching and counseling services in decision-making. Through elaborative discussion the staff will improve their knowledge and skills in correct CTG interpretation, thus preventing unnecessary interventions, such as cesarean sections."
15793506|NCT04504500|Other|Follow-up meetings|Regular follow-up meetings of the participating obstetricians with members of the steering committee and local opinion leaders throughout the intervention period will enhance compliance with the guidelines. Establishment of commonly accepted practice augments the homogeneity of clinical action plans and team work in the unit.
15793507|NCT04504487|Other|Drain Removal|Abdominal drain placed during surgery removal
15793508|NCT04504461|Other|Analysis of feasibility and costs|Analyze the feasibility and costs of performing laparoscopic inguinal hernioplasty in an ambulatory surgery center
15793509|NCT04504448|Drug|HNC664 capsules Single dose|HNC664 capsules,single ascending doses Single dose, PO,starting dose of 40mg escalating up to 500mg
15793510|NCT04504448|Drug|HNC664 placebos Single dose|HNC664 placebos single ascending doses,PO,Single dose, matching placebo
15793511|NCT04504448|Drug|HNC664 capsules FED|HNC664 capsules,single doses Single dose, PO,food effect（dosage will be based on data from SAD cohorts and decided by the IDRC）
15793514|NCT04504422|Device|transcranial Direct Current Stimulation (tDCS)|tDCS was applied for 20 minutes through two saline-soaked sponge electrodes (diameter 6cm) using the YMS-201B (Ybrain Inc, South Korea).
15793515|NCT04504409|Other|Rehabilitation|Training
15793561|NCT04504045|Drug|Caffeine|As part of a 6-drug cocktail caffeine 100 mg tablet will be administered as a single dose before the initiation of metformin treatment and 3 weeks and 12 weeks after. The drug will be used as a probe to assess CYP1A2 activity.
15793522|NCT04504357|Behavioral|Tablet based U=U app|"Tablet based app focusing on TasP/U=U videos on: a) the science of TasP/U=U including risks, (b) benefits to self (e.g. psychological benefits, ability to have children), (c) benefits to partners (e.g. secondary prevention), (d) benefits to society (e.g. AIDS-free generation), and (e) TasP self-efficacy, including viral load (VL) literacy, disclosure, and couples testing."
15793523|NCT04504357|Behavioral|U=U videos played in clinic waiting rooms and integrated into HIV counseling session|TasP/U=U videos on: a) the science of TasP/U=U including risks, (b) benefits to self (e.g. psychological benefits, ability to have children), (c) benefits to partners (e.g. secondary prevention), (d) benefits to society (e.g. AIDS-free generation), and (e) TasP self-efficacy, including viral load (VL) literacy, disclosure, and couples testing.
15793524|NCT04504357|Other|Text messages|Monthly text messages reinforcing intervention content
15793525|NCT04504344|Device|Anodal transcranial direct current stimulation (tDCS) - Soterix Medical Inc, 1x1 tDCS (conventional)|We will compare the effects of active versus sham tDCS on quadriceps strength and corticospinal excitability in patients recovering from ACLR.
15793526|NCT04504331|Drug|Infigratinib|Oral dose
15793527|NCT04504331|Drug|Tamoxifen|Oral Dose
15793528|NCT04504331|Drug|Omnipaque 350|IV contrast agent
15793529|NCT04504331|Drug|Iopamidol|IV contrast agent
15793530|NCT04504318|Drug|Apixaban 2.5 MG Oral Tablet|Patients will be assigned to the respective study groups postoperatively upon arrival in the post-anesthesia care unit. Hence, surgeons are blinded at the time of surgery as to study group assignment. Chemoprophylaxis will continue for the duration of the hospitalization.
15793531|NCT04504318|Drug|Enoxaparin 40Mg/0.4mL Prefilled Syringe|Patients will be assigned to the respective study groups postoperatively upon arrival in the post-anesthesia care unit. Hence, surgeons are blinded at the time of surgery as to study group assignment. Chemoprophylaxis will continue for the duration of the hospitalization.
15793532|NCT04504305|Other|NeuropAWAY|2 capsules thrice daily to be taken half an hour prior to meal.
15793533|NCT04504305|Other|Microcystalline cellulose|2 capsules thrice daily to be taken half an hour prior to meal.
15793534|NCT04504292|Drug|SUPREP Bowel Prep Kit|Bowel prep prior to colonoscopy
15793535|NCT04504292|Drug|Golytely Oral Product|Bowel prep prior to colonoscopy
15793536|NCT04504279|Biological|FB-401|Topical application
15793537|NCT04504279|Biological|Placebo|Vehicle
15793538|NCT04504266|Behavioral|POWER|This intervention consists of a motivational interview and a mobile-app based coaching program to encourage patients to exercise and adopt a Mediterranean diet in the 3+ weeks prior to surgery.
15793542|NCT04504227|Dietary Supplement|Thin liquid swallows|Thin liquid swallows of formula or breastmilk or other liquid
15793543|NCT04504227|Dietary Supplement|Slightly thickened liquid swallows|Slightly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix
15793544|NCT04504227|Dietary Supplement|Mildly thickened liquid swallows|Mildly thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix
15793545|NCT04504227|Dietary Supplement|Moderately thickened liquid swallows|Moderately thick liquid swallows of formula thickened with rice cereal or breastmilk or other liquid thickened with Gelmix
15793546|NCT04504214|Other|Upper limb repeated multi-site tendon vibrations|Upper limb tendon vibration protocol will be added to the usual rehabilitation protocol performed during hospitalization
15793547|NCT04504201|Other|Focus Group|Breast cancer patients and oncology clinicians will participate in separate focus groups discussing patient-centered communication about healthy weight.
15793548|NCT04504188|Device|Heart Rate Monitor Enhanced Treatment Optimization|Heart rate (HR) will be continuously monitored by the WCD. Every two weeks a report showing daily HR trends will be emailed to the healthcare provider. The healthcare provider will also receive a HR control alert if the HR exceeds a predetermined threshold for 3 days in a row.
15793549|NCT04504175|Drug|Ketamine|ketamine will be infused using an IV infusion pump at a rate of 0.5 mg/kg of body weight over 40 minutes
15793550|NCT04504149|Behavioral|Patient Readiness for Improvement through Motivation, Engagement, and Decision-making for PTSD|A primary care-based shared decision making intervention
15793551|NCT04504136|Procedure|Serial Biopsy|"During the initial colonoscopy, 16-20 biopsies will be collected in addition to standard of care biopsies, and biopsy sites will be tattoed. Patients will return for a follow-up colonoscopy 4-35 days later. An additional 16-20 biopsies will be collected in a biopsy of the biopsy approach."
15793552|NCT04504123|Drug|Doxycycline Hyclate|Doxycycline Hyclate capsules, USP 50 mg
15793553|NCT04504123|Drug|Placebo|Placebo
15793554|NCT04504110|Diagnostic Test|68Ga-FAPI-04 PET/CT and 18F-FDG PET/CT|Patients with epithelial ovarian cancer who are scheduled for surgical intervention will undergo a comparative 68Ga-FAPI-04 and 18F-FDG PET/CT study before the surgery.
15793555|NCT04504097|Behavioral|m-Health|Participants receive a weekly bidirectional text message (SMS) asking how they are doing. They are requested to reply fine, or not fine, in which case they will be contacted with support by a peer navigator. If they do not reply to the message within the specified timeframe a peer navigator will follow up with them.
15793556|NCT04504097|Diagnostic Test|HIV self-testing|Participants will receive HIVST kits so that they can perform their HIV testing.
15793557|NCT04504084|Other|Decision aid|Patient Decision Aid is a tool that helps patient with ureteral stone become involved in decision making on choosing treatment for ureteral stone. Patient Decision Aid provides information about the options and outcomes, and by clarifying personal values.
15793558|NCT04504071|Drug|Dacomitinib|Patients will receive continuous oral therapy with the study drugs (dacomitinib 45 mg) until disease progression or unacceptable toxicity.
15793559|NCT04504058|Other|routine clinical treatment|Participants will be informed that this is not a treatment study and it involves naturalistic follow-up without any extra intervention. They will otherwise follow the routine clinical treatment procedure.
15793560|NCT04504045|Drug|Metformin|500 mg tablet
15794105|NCT04499924|Drug|paclitaxel|60 or 80 mg/m^2 IV on Days 1, 8, and 15 of each cycle
15793562|NCT04504045|Drug|Efavirenz|As part of a 6-drug cocktail efavirenz 50 mg coated tablet will be administered as a single dose before the initiation of metformin treatment and 3 weeks and 12 weeks after. The drug will be used as a probe to assess CYP2B6 activity.
15793563|NCT04504045|Drug|Losartan|As part of a 6-drug cocktail losartan 12.5 mg coated tablet will be administered as a single dose before the initiation of metformin treatment and 3 weeks and 12 weeks after. The drug will be used as a probe to assess CYP2C9 activity.
15793564|NCT04504045|Drug|Omeprazol|As part of a 6-drug cocktail Omeprazol 10 mg enteric-coated tablet will be administered as a single dose before the initiation of metformin treatment and 3 weeks and 12 weeks after. The drug will be used as a probe to assess CYP2C19 activity.
15793565|NCT04504045|Drug|Metoprolol|As part of a 6-drug cocktail metoprolol 12.5 mg release tablet will be administered as a single dose before the initiation of metformin treatment and 3 weeks and 12 weeks after. The drug will be used as a probe to assess CYP2D6 activity.
15793566|NCT04504045|Drug|Midazolam|As part of a 6-drug cocktail midazolam 2 mg oral solution will be administered as a single dose before the initiation of metformin treatment and 3 weeks and 12 weeks after. The drug will be used as a probe to assess CYP3A4 activity.
15793569|NCT04504019|Device|USCTR|Ultrasound guided CTR via a single < 1 cm wrist or palmar incision. The procedure will be performed using the SX-One MicroKnife®
15793570|NCT04504019|Procedure|mOCTR|Mini-open CTR via a single 1-3cm palmar incision
15793571|NCT04504006|Procedure|Peritoneal Mesometrial Resetion + Targeted Compartmental Lymphadenectomy (PMMR+TCL)|Peritoneal Mesometrial Resetion + Targeted Compartmental Lymphadenectomy (PMMR+TCL)
15793572|NCT04503993|Other|Hepatitis B surface antigen, Hepatitis B core antibody, and Hepatitis B surface antibody|The hepatitis B tests are released into the electronic medical charts of at-risk patients who have never been screened for chronic hepatitis B using population health tools.
15793573|NCT04503980|Biological|αPD1-MSLN-CAR T cells|Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of αPD1-MSLN-CAR T cells. During αPD1-MSLN-CAR T cells production, subjects will receive cyclophosphamide for the purpose of lymphocytes depletion. After lymphodepletion, subjects will receive one dose treatment with αPD1-MSLN-CAR T cells by intravenous (IV) injection. The initial dose of 1×10^5 CAR+ T cells/kg will be infused on day 0.
15793574|NCT04503967|Drug|Anlotinib Hydrochloride With Nivolumab|Anlotinib Hydrochloride Combined With Nivolumab in the second line Treatment of Gastric and Esophageal Cancer patients
15793575|NCT04503954|Other|Chronic disease self-management program|The chronic disease self-management program is based on the self-efficacy theory for improving health behavior, by the solve health problem skill, health life style, emotion management skill, improve intention of health condition in people with chronic disease.
15793576|NCT04503954|Other|General psychiatric intervention|General psychiatric intervention contains the activities in psychiatric center.
15793577|NCT04503941|Device|Acupuncture treatment|Acupuncture treatment will be the Traditional Chinese Medicine type. Acupuncture 3 times per week, 4 weeks is one treatment period. Every patient will be given 3 treatment period.
15793578|NCT04503941|Device|False Needle treatment|False Needle treatment treatment will be the Traditional Chinese Medicine type. Acupuncture 3 times per week, 4 weeks is one treatment period. Every patient will be given 3 treatment period.
15793579|NCT04503928|Drug|Euphorbia kansui Pill|1 g (10 pills) of Euphorbia kansui Pill taken by mouth, once a day for 7 consecutive days.
15793580|NCT04503915|Procedure|different estrogen supplementation modes|The different estrogen supplementation modes are randomized into two groups.
15793581|NCT04503902|Drug|Donafenib Tosilate Tablets|In the dose exploration phase (phase I)，three doses of Donafenib tosylate tablets [100 mg once a day (QD); 100 mg twice a day (BID); 200 mg, BID] will be explored. In the dose expansion phase (phase II), patients will be treated at the recommended dose for phase 2(RP2D).The RP2D will be determined by the dose escalation study.
15793582|NCT04503902|Drug|Toripalimab Injection|JS001 will be administrated by intravenous (i.v.) infusion once every 21 days
15793583|NCT04503889|Device|Transauricular electrical vagal nerve stimulation|transauricular electrical vagal nerve stimulation will be applied to the cymba conchae of both ears using ECO2 TENS device (manufactured by Schwa-Medico GmbH/Germany) with currency intensity of max 10 mA and current frequency 2/100 Hz.
15793584|NCT04503889|Device|taVNS sham|ECO2 TENS device (manufactured by Schwa-Medico GmbH/Germany)
15793585|NCT04503876|Other|Increasing PEEP setting|End expiratory lung volume and lung aeration measurements will be conducted using electrical impedance tomography and nitrogen washin-washout method. Measurements will be conducted during the last minute of each step.
15793586|NCT04503876|Other|Decreasing PEEP setting|End expiratory lung volume and lung aeration measurements will be conducted using electrical impedance tomography and nitrogen washin-washout method. Measurements will be conducted during the last minute of each step.
15793587|NCT04503863|Drug|NPC-22|Single administration of middle dose NPC-22
15793588|NCT04503863|Drug|NPC-22|Single administration of high dose NPC-22
15793589|NCT04503863|Drug|NPC-22 Placebo|Single administration of NPC-22 Placebo
15793590|NCT04503850|Drug|Mirabegron 50 MG|Mirabegron 50 mg daily dose and follow Up of erectile function using international index of erectile function 5 scoring system
15793591|NCT04503850|Drug|Alpha Blockers|Alpha blocker daily and evaluation of erectile function using international index of erectile function 5 scoring system
15793592|NCT04503837|Procedure|Personalized Mobile Phone Video Recording|Subjects will be asked to perform inhaler technique while on video recording. The video will be shown to subjects immediately during technique education session and mistakes (if any) will be pointed out to subject.
15793593|NCT04503824|Diagnostic Test|saliva samples|Salivary expression of lncRNA DQ786243 and IL-17 will be evaluated using qRT-PCR.
15793594|NCT04503798|Behavioral|Online Goal Management Training|Pre-recorded videos and games combine psycho-education, targeted skills training, and mindfulness practice to teach a system where participants can take control of their attention and cognitive faculties.
15793595|NCT04503785|Diagnostic Test|Manometry|Transnasal Esophageal manometry and Endoflip Balloon distensibility
15793597|NCT04503759|Other|NanoBone Bone Graft Substitute|Synthetic, biodegradable bone grafting material that is composed of non-sintered nanocrystalline hydroxyapatite (HA) which is embedded in a silica gel matrix (amorphous SiO2). The ratio of HA/SiO2 has been chosen to optimize the rate of biodegradation for treatment of osseous defects in human bone. NanoBone does not contain any components of animal or human origin, eliminating the possibility of transmission of infection or disease.
15793598|NCT04503746|Drug|ALH-L1005 600mg/day|ALH-L1005 300mg 2 tablet and placebo 2 tablet
15793599|NCT04503746|Drug|ALH-L1005 1,200mg/day|ALH-L1005 300mg 4 tablet
15793600|NCT04503746|Drug|Placebo|Placebo 4 tablet
15793601|NCT04503733|Drug|Q4W GMA301 IV injections (300 mg)|Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.
15793602|NCT04503733|Drug|Q4W GMA301 IV injections (600 mg)|Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.
15793603|NCT04503733|Drug|Q4W GMA301 IV injections (1000 mg)|Each cohort will contain 12 subjects, 9 of whom will be administered active GMA301 and 3 of whom will be administrated placebo.
15793604|NCT04503733|Other|Q4W placebo IV injections|Placebo is indistinguishable from GMA301
15793605|NCT04503720|Device|CLoWI|Patients will receive a continuous wound infusion with ropivacaine and normal saline in the PCA pump.
15793606|NCT04503720|Device|PCA|Patients will receive a continuous wound infusion with normal saline and morphine in the PCA pump.
15793607|NCT04503707|Drug|Follitropin Delta|The Intervention (solution for injection) is delivered with a pre-filled injection pen. The REKOVELLE dose will be based on a recent determination (within the last 12 months) of AMH (anti- müllerian hormone) measured by the ELECSYS AMH Plus Immunoassay.
15793608|NCT04503694|Drug|Nivolumab 10 MG/ML Intravenous Solution|"Nivolumab will be given at a dose of 240 mg during the pre-operative phase only as indicated below:
~On day 1 and 14, during the Induction systemic period 1
~On day 28, 42 and 56, during the Induction systemic period 2"
15793609|NCT04503694|Drug|Regorafenib 40 MG Oral Tablet|"Regorafenib will be administered orally once a day at a dose of 80 mg/day (2 tablets of 40 mg), during the pre-operative phase only as indicated below:
~From day 1 to 14, during the Induction systemic period 1
~From day 28 to 49, during the Induction systemic period 2"
15793610|NCT04503694|Radiation|Radiotherapy|All study subjects will receive 5 daily fractions of radiotherapy. Each fraction will consist of 5 Gy for a total dose of 25 Gy. Radiotherapy is to start on day 21 and to finish on day 25.
15793611|NCT04503694|Procedure|Surgery|Subject will undergo surgical resection of the primary tumour in the rectum between day 74 and 87. Surgery must be performed according to the principles of total mesorectal excision as described by Heald et al. The type of surgical approach (low anterior resection or abdominoperineal resection, etc.) will be left to the discretion of the treating surgeon.
15793612|NCT04503681|Other|Enhanced compassion video|"Added five additional sentences to the standard introduction video. Those five sentences were compassion-focused statements. The compassionate statements added to the enhanced compassion video were based on the results of a recent systematic review of clinician compassionate behaviors, which found incorporating statements of support, acknowledgement, patient's perspective, emotion naming, and validation increased patient perception of compassion."
15793613|NCT04503681|Other|Standard introduction video|Standard introduction video sent to a new patient via email introducing the new patient to the cancer center prior to the initial consultation.
15793614|NCT04503668|Drug|Ondansetron|8 mg IV or 16 mg by mouth on day 1 pre-chemotherapy; then 8 mg by mouth twice a day on days 2-4 of chemotherapy
15793615|NCT04503668|Drug|Dexamethasone|20 mg IV on day 1 pre-chemotherapy
15793616|NCT04503668|Drug|Neurokinin-1 Receptor Antagonist (NK1-RA)|150 mg IV on day 1 pre-chemotherapy
15793617|NCT04503668|Drug|Olanzapine|5 mg by mouth on days 1-4 of chemotherapy (taken at night)
15793618|NCT04503668|Drug|Compazine|5-10 mg by mouth, available as needed, every 6 hours, days 1-5
15793619|NCT04503655|Other|Training|"Training dedicated on implementation of organizational and therapeutic measures (for prevention and management of complications) to reduce lenght-of-stay after TF TAVI."
15793620|NCT04503642|Procedure|Changing the surgical team for wound closure|The intervention consists of the exchange of the primary surgical team with a second surgical team that consists of one surgeon and one student. The first surgical team then may leave the operation theatre but is continuously accessible for questions.
15793621|NCT04503629|Drug|Anaprazole Sodium|Anaprazole Sodium 20mg
15793622|NCT04503629|Drug|Anaprazole Sodium|Anaprazole Sodium 40mg
15793623|NCT04503629|Drug|Rabeprazole sodium|Rabeprazole sodium 10mg
15793624|NCT04503616|Drug|Cyclophosphamide, Abatacept, and Tacrolimus for GvHD Prevention|Cyclophosphamide 50 mg/kg IV over 2 hours on Day +3 and +4 Abatacept 10 mg/kg IV on days +5, +14, and +28 Tacrolimus 0.02 mg/kg IV by continuous infusion, starting on day +5. May switch to oral when tolerated, adjusted to maintain a drug level between 5-12ng/mL. Treatment is discontinued on day +60 after a 4 week-taper
15793625|NCT04503603|Drug|Lanadelumab|Participants will receive lanadelumab 300 mg IV infusion on Day 1 followed by Day 4.
15793626|NCT04503603|Other|Placebo|Participants will receive placebo matching to lanadelumab IV infusion on Day 1 followed by Day 4.
15793627|NCT04503590|Device|Minimally Invasive Micro Sclerostomy (MIMS)|The System is a surgical device, designed to create a drainage channel at the sclera-corneal junction . The drainage channel is created by a Stainless Steel surgical tool.
15793628|NCT04503564|Device|coil-reinforced soft polymer indwelling cannula|This is a prospective, non-randomized, home-use feasibility study of device performance, usability, tolerability, and safety of the Capillary Biomedical, Inc. (CapBio) Achilles infusion set for continuous subcutaneous insulin infusion (CSII or insulin pump therapy) in up to 20 participants diagnosed with type 1 diabetes mellitus (T1DM).
15793657|NCT04503265|Drug|AMXI-5001:Dose Escalation Phase I|Phase I will enroll up to 30 participants to identify the Recommended Phase II daily dose in the treatment of various cancers and to characterize the safety, pharmacology, and clinical efficacy of AMXI-5001. AMXI-5001 is administered orally twice daily, without food. AMXI-5001 is administered weekly on a 4-day ON, 3-day OFF schedule. Each cycle is 28 days.
15793631|NCT04503538|Other|Telemedicine visit|Participants will be provided with a Wifi-and cellular enabled electronic tablet. Additionally, participants will receive a kit that contains a thermometer, a blood pressure monitoring cuff, and a pulse oximeter (to measure oxygen saturation level). Participants will attend an educational session to learn how the telemedicine visit works. Caregivers should attend with participants and will be trained to take temperatures, blood pressures, and oxygen saturation levels. Participants will also be asked to complete a test telehealth visit.
15793632|NCT04503525|Other|Nutritional assessment|Nutritional assessment in COVID patients
15793633|NCT04503512|Procedure|removal of fat pad|Removal removal of fat pad
15793634|NCT04503512|Procedure|non removal of fat pad|non removal of fat pad
15793635|NCT04503499|Other|Manuel Therapy|"The manual therapy protocol will consist of 45-60 minutes and the following techniques;
~suboccipital decompression
~cervical mobilization (in the posterior-anterior direction)
~sternocleidomastoid release
~scalene release
~trapezoidal release
~scalene release
~pectoralis tractus
~sternoclavicular joint mobilization
~sternum mobilization
~parasternal circumference intercostal and paravertebral release
~diaphragm release
~rib reasing
~scapulothoracic joint mobilization
~thoracic vertebra mobilization
~Myofascial release techniques will be applied for 3-5 minutes each.
~Mobilization techniques were applied in each joint for 30 seconds and 5 times."
15793636|NCT04503486|Diagnostic Test|handgrip strength|measure of handgrip strength using Jamar Dynamometer and a standardized protocol, strength expressed in kg
15793637|NCT04503486|Diagnostic Test|quadriceps strength|maximal isometric quadriceps strength measured using a handheld dynamometer and a standardized protocol, strength expressed in Newton
15793638|NCT04503473|Behavioral|High Intensity Stepping Training|"The goals will be to maximize stepping activity at high intensities for 40 minutes per 1 hour session, with rest breaks as needed
~Conventional Therapy: : Participants provided conventional therapy will perform various standardized exercise tasks during 40 minutes of 1 hr sessions"
15793639|NCT04503473|Behavioral|Conventional Therapy|Participants provided conventional therapy will perform various standardized exercise tasks during 40 minutes of 1 hr sessions
15793640|NCT04503460|Drug|Salmeterol Xinafoate|All participants will receive inhaled salmeterol xinafoate 50 μg twice in the morning and twice in the evening for 2 weeks; this will be followed by a 2-week washout period during which time no beta-agonists will be administered. Participants will be asked to use 'as required' ipratropium bromide during this period when needed in place of short-acting beta agonists.
15793641|NCT04503460|Drug|Salmeterol Fluticasone|Following the 2-week washout period, all participants will receive inhaled salmeterol xinafoate 50 μg combined with fluticasone propionate 250 μg twice in the morning and twice in the evening for 2 weeks. Participants will be asked to use 'as required' ipratropium bromide during this period when needed in place of short-acting beta agonists.
15793642|NCT04503421|Other|Blood Flow Restriction Therapy|Use of a tourniquet set to 50% of limb occlusion pressure while performing post operative physical therapy
15793643|NCT04503395|Device|ESAR treatment: Endograft + Heli-FX Endoanchor|ESAR treatment: Endurant II or Endurant IIs endograft + Heli-FX Endoanchor
15793644|NCT04503395|Device|FEVAR treatment : Fenestrated endograft|Cook Zenith Fenestrated Graft or the Terumo Fenestrated Anaconda Graft
15793645|NCT04503382|Other|Kindness Media|As described above, the intervention is a series of short videos that display acts of kindness or ideas about kindness. These videos are edited together into one reel that was 8 minutes long.
15793646|NCT04503369|Behavioral|Non-technical skills|"Teamwork The work of the team consists of information exchange and coordination of all activities performed. In-team communication is always calm and assertive, and team members support each other.
~Task management With the right planning and preparation of individual activities, the likelihood that all standards of care and best practices will be followed increases.
~Situational awareness Situational awareness refers primarily to the collection of information, its understanding and, on that basis, prediction of direction into which the situation will develop. Maintaining situational awareness is crucial in order to move towards the right goal.
~Decision-making With good situational awareness, one is able to keep in mind all information needed to make the correct decision at the right time. In some cases, it is advisable to consult with other team members or to verify their consent to the proposed procedure.
~Communication Communication is a vital tool when working in a team."
15793647|NCT04503356|Procedure|OMNI as a standalone procedure|It uses a single, self-sealing clear corneal incision with ab-interno transluminal 360 degree viscodilation of Schlemm's canal followed by up to 360 degree trabeculotomy performed using the OMNI Surgical System as a standalone procedure.
15793648|NCT04503356|Procedure|OMNI combined with cataract surgery|Phacoemulsification with intraocular lens implantation is performed. Then, ab-interno transluminal 360 degree viscodilation of Schlemm's canal followed by up to 360 degree trabeculotomy performed using the OMNI Surgical System.
15793649|NCT04503343|Other|non-drug intervention|mindfulness training, relaxation training, or electrical cerebellar stimulation
15793650|NCT04503330|Procedure|buccal mucosal graft to repair iatrogenic PUJO|Augmented buccal mucosal graft anastomosis to repair iatrogenic PUJO or long segment ureteric stricture disease
15793651|NCT04503317|Device|active acupuncture low level laser in addition to nasal laser irradiation|laser consists of a semiconductor and operates at a wavelength of 650 nanometre. The laser installed in the watch comprises 10 individual laser beams for the wrist and an additional adapter for nasal stimulation. The output power is 5 megawatt, but it can also be adjusted. The device operates at an ambient temperature of -20 to +40 ° C and relative humidity of ≤ 85%. The laser watch can be used for a variable irradiation period of 10-60 min. the device will be applied on specific acupuncture points ( acupuncture point, Radial artery acupuncture points, and ulnar artery acupuncture points) combined with nasal laser irradiation at the same time with treadmill aerobic exercises, once per day, 3 times per week for three months
15793652|NCT04503317|Other|treadmill exercise|aerobic exercises once per day, 3 times per week for three months
15793653|NCT04503304|Other|Exercises|already included in arm/group descriptions.
15793654|NCT04503291|Procedure|Metal stent placement|Non-covered biliary metal stents are placed by endoscopy. The distal ends of metal stents are located above the major ampulla in the common bile duct or below the major ampulla in the duodenum.
15793655|NCT04503278|Biological|CLDN6 CAR-T|administered as an i.v. infusion.
15793656|NCT04503278|Biological|CLDN6 RNA-LPX|administered as an i.v. injection at protocol-specified intervals.
15793658|NCT04503265|Drug|AMXI-5001:Dose Expansion Phase II|Phase II will enroll up to 52 study participants to further characterize the safety, pharmacology, and clinical efficacy of AMXI-5001. AMXI-5001 is administered orally twice daily, without food. AMXI-5001 is administered weekly on a 4-day ON, 3-day OFF schedule. Each cycle is 28 days.
15793659|NCT04503252|Other|Blood samples for the measurement of the concentration of cefazolin|Blood samples for the measurement of the concentration of cefazolin will be collected on the 1st (mid-dose and trough sample), 3rd (mid-dose and trough sample),7th and 14th day (for both only trough sample) of cefazolin treatment (+/-1-5 day) and if applicable in weekly intervals during outpatient parenteral antibiotic treatment (usually within 4 weeks after inclusion; only in patients on outpatient continuous parenteral antibiotic treatment).
15793660|NCT04503252|Other|S. aureus culture isolate|The S. aureus culture isolate will be subjected to exact cefazolin MIC determination and to measurement of the level of cefazolin tolerance.
15793661|NCT04503252|Other|structured telephone interview|Structured telephone interview for Patient follow- up after 30 days
15793662|NCT04503252|Other|Sub-study quantitative measurement of Torque Teno virus|An additional EDTA sample will be drawn for quantitative polymerase chain reaction (PCR) of TTV DNA and analyses of cytokines and other parameters of the activation state of the immune system.
15793663|NCT04503252|Other|Sub-study investigating cefazolin concentrations in sweat|For each visit of included patients, a sweat sample will be collected via a CE certified Macroduct Sweat Collector. Eccrine sweat glands of the lower forearms are stimulated by pilocarpine (a parasympathomimetic) as well as a local current for 5min. Sweat is subsequently collected by capillary containers during 30min and transferred to small tubes on dry ice. Sweat sample analysis is conducted using mass spectrometry.
15793664|NCT04503239|Device|G6|Wear 9 wear periods of the 10-day CGM
15793665|NCT04503200|Procedure|Double guidewire|After the 3rd passage of the guidewire into the pancreatic duct, the catheter will be removed leaving the guidewire in place. The catheter will be re-inserted and a second guidewire will be used and directed above the pancreatic wire in the 11-12 o'clock direction to attempt cannulation of the common bile duct.
15793666|NCT04503200|Procedure|Transpancreatic precut|After the 3rd passage of the guidewire unintentionally into the pancreatic duct, the guidewire will be left in the pancreatic duct, a sphincterotome will be used to cut in the direction of 11-12 o'clock attempting to deroof the pancreatic duct and gain access into the common bile duct. The wire will then be retracted and reinserted in the direction of the cut to attempt cannulation of the common bile duct.
15793667|NCT04503187|Behavioral|Visuomotor leg reaching task|Similar to a hand reaching task in which participants were asked to reach to a tea-cup, in a visuomotor leg reaching task, participants will be seated and given real-time visual feedback about their leg movements via a cursor display on a computer screen. The task is to control a foot mouse/marker attached to the foot and move the cursor from a start location to the target displayed on a wall screen. Three different targets, equidistant from the start location at top, top-left, and top-right screen positions, will be used for leg reaching. In each trial, one of three targets will be randomly presented and subjects will be instructed to make forward, or rightward, or leftward foot reaches to guide the cursor to one of the targets. Throughout the entire experiment, subjects are blocked from viewing leg movements by a cardboard.
15793668|NCT04503174|Device|t:slim X2 pump with Control-IQ technology|Real-world use
15793669|NCT04503161|Device|Duragen with Collagen Hydrodel and ASCs|Duragen combined with collagen hydrogel and patient's stem cells
15793670|NCT04503148|Drug|Propofol|Propofol 1-2 mg/kg bolus injection for induction of anesthesia propofol continuous infusion for maintenance of anesthesia
15793671|NCT04503148|Drug|Inhaled General Anesthetics|Sevoflurane or desflurane for induction and maintenance of anesthesia
15793672|NCT04503135|Diagnostic Test|ultrasound|ultrasound of the central veins of the neck and chest and a (compression ultra-sound) CUS of the femoral veins will be performed bilaterally
15793673|NCT04503122|Procedure|pulmonary vein isolation|pulmonary vein isolation : cryoablation or radiofrequency
15793674|NCT04503109|Device|Nalu Neurostimulation System|The Nalu Neurostimulation System is a Spinal Cord Stimulation system
15793675|NCT04503096|Device|High-dose accelerated rTMS|A MagVenture MagPro Transcranial Magnetic Stimulation (TMS) System will be utilized. All participants will receive open-label treatment for approximately eight, 3-minute sessions of intermittent theta burst rTMS on each of three days within an eight-day span. A single session = 600 pulses at 120% rMT, intermittent Theta Burst Stimulation (iTBS) triplets at 50 Hz for 2 seconds and repeated every 10 seconds for a total of 190 s to left dorsolateral prefrontal cortex. Total pulses = 14,400. To enable adherence and retention, the days do not need to be contiguous. Same day sessions will be separated by 10-15 minutes, but more accounting for participant comfort.
15793676|NCT04503070|Behavioral|Motion capture participant|"Once participants have undergone appropriate calibration processes, they will perform listed swing progressions:
~15 dry swings with a wiffle bat at low, medium and high effort
~15 dry swings with a weighted bat at low, medium and high effort
~15 swings off of a tee at low, medium and high effort
~15 swings at an underhand toss at low, medium and high effort
~15 swings from a pitching machine at low, medium and high effort"
15793677|NCT04503044|Other|Retrospective observational study|No intervention to occur
15793678|NCT04503031|Device|TaperGuard endotracheal tube|TaperGuard endotracheal tube is intubated
15793679|NCT04503031|Device|cylindrical endotracheal tube|endotracheal tube is intubated
15793680|NCT04503005|Other|Time Restricted Eating|Effect of 16, 14 or 12 hours of daily fasting
15793681|NCT04502992|Behavioral|Acceptance and Committment Therapy|Acceptance and Commitment Therapy (ACT) is a mindfulness-based therapy that focuses on enabling individuals to accept what is out of their control, and to commit to valued actions that enrich their lives (Vowles & McCracken, 2008). By emphasizing acceptance instead of avoidance, ACT differs from many other forms of cognitive behavioral therapy. ACT has been shown to be efficacious in terms of clinical outcomes, adherence to treatment, and retention. ACT aims to increase psychological flexibility, and has been associated with improved health outcomes prior randomized controlled clinical trials, including three systematic reviews specific to CP. Psychological flexibility is defined as an individual's ability to recognize and adapt to various demands; shift mindsets or behavioral responses when these strategies compromise personal or social functioning; and maintain balance among important life domains.
15793711|NCT04502771|Drug|Antifungal treatment|Treatment by fluconazole, voriconazole,posaconazole or caspofungin during the patient stay in Intensive Care Unit
15793682|NCT04502979|Behavioral|Responsive Feeding Training|Families will receive 4 monthly 1-hour sessions: (1) Signing with infants; (2) infant communication and responsive feeding; (3) nutrition, portion sizes, and neophobia; and, (4) infant intentionality.
15793683|NCT04502966|Biological|Dupixent®|An initial dose of 600 mg (two 300 mg injections), followed by 300 mg administered every other week (biweekly), by subcutaneous injection.
15793684|NCT04502966|Biological|Grazax®|"One Grazax® tablet daily, by sublingual administration.
~Grazax® is formulated as a freeze-dried oral lyophilisate/orally disintegrating tablet for oromucosal use. The active pharmaceutical ingredient is a standardized allergen extract derived from extraction and purification of grass pollen from timothy grass (Phleum pratense). The biological activity of the allergen is expressed in Standardized Quality Tablet units (SQ-T) units. The Grazax® dosage is one oral lyophilisate (75,000 Standardized Quality Tablet units (SQ-T) or approximately 2800 Bioequivalent allergy units (BAU), a measure of Phleum pratense SQ total biological potency defined by the FDA."
15793685|NCT04502966|Drug|Dupixent® Placebo|"Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose followed by a single injection administered every other week.
~Dupixent® placebo is a subcutaneous injection whose composition is identical to the active Dupixent®, with the exception of the active pharmaceutical ingredient."
15793686|NCT04502966|Drug|Grazax® Placebo|"One tablet of Placebo (for Grazax®) daily, by sublingual administration.
~Grazax® placebo is a tablet whose composition is identical to the active Grazax® tablet with the only exception being exclusion of the active pharmaceutical ingredient, Phleum pratense Standardized Quality Tablet (SQ-T) units."
15793687|NCT04502953|Procedure|Vertical plication|Vertical plication of the rectovaginal septum was done
15793688|NCT04502953|Procedure|Horizontal plication|Horizontal plication of the rectovaginal septum was done
15793689|NCT04502940|Diagnostic Test|Flow Cytometric analysis|Blood samples will be taken from the patients with biliary pancreatitis and healthy volunteers to perform flow-cytometric analysis and to determine lymphocyte subgroups
15793690|NCT04502927|Procedure|Passive extension mobilization of the hand and wrist joints|"The physiotherapist will proceed with the passive mobilization of the spastic hand of the stroke patient or the dominant hand for healthy volunteers.
~Two mobilizations will be performed for each participant, i.e. one for each type of medial or lateral grip. The order of mobilization will be determined by randomization."
15793691|NCT04502914|Procedure|Open-to-air strategy|In open-to-air management, the wound will be washed with a chlorhexidine solution and leave the wound open, or portion of the wound assigned to OTA, to the environment. An electric heat lamp (model no. 53103, 250W, Brandt Industries LLC, Bronx, NY) will be placed at as close to 1 yard (0.91 m) as possible from the wound after daily wound care for 24 hours (+/- 6 hours) to promote drying. However, to prevent excessive drying an hourly spritz of topical solution, e.g., DuoDERM® Hydroactive® gel (ConvaTec Oklahoma City, OK) will be used at the bedside.
15793692|NCT04502914|Procedure|Traditional closed-wound management|In traditional closed-wound management, once a day the wound will be washed with a chlorhexidine solution and closed with a non-adherent dressing such as ADAPTIC® (Acelity, San Antonio, TX) soaked in topical antimicrobial solutions, ointments, and creams designed to promote wound healing.
15793693|NCT04502901|Drug|KX0826|investigational AR antagonist
15793694|NCT04502901|Other|Placebo|Placebo of KX-826
15793696|NCT04502875|Drug|PRP|Platelet Rich Plasma (PRP) is an autologous blood component derivate from the own patient blood, with a high concentration in platelets. The liquid fraction obtained after the soft centrifugation of Whole Blood (WB) collected with anticoagulant, in a way that most of the red cells and leukocytes are sedimented and removed, but most of the platelets are kept in the supernatant plasma. The platelet concentration in PRP is not well defined.
15793697|NCT04502875|Drug|PPP|PPP is the liquid fraction obtained after the hard centrifugation of WB collected with any anticoagulant. PPP does not contain cells. (Hematocrit lower than 1% and leukocytes below 1 x 109/L) x but contains WB proteins (including clotting factors), ions, microelements and water. PPP can be also being collected using an apheresis technique.
15793698|NCT04502862|Drug|SAR231893|Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous
15793699|NCT04502862|Drug|Placebo|Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous
15793700|NCT04502849|Procedure|Bypass surgery|Creating a bypass with graft or vein.
15793701|NCT04502849|Procedure|Endovascular angioplasty/stenting|Performing an angioplasty with or without stenting in stenosis.
15793702|NCT04502849|Procedure|Hybrid surgery|Performing an angioplasty with or without stenting in stenosis and creating a bypass with graft or vein.
15793703|NCT04502849|Drug|Vitamin E|100 mg Vitamin E per os 1 per day (1 month).
15793704|NCT04502849|Diagnostic Test|Duplex ultrasound|Duplex ultrasound of lower limbs arteries.
15793705|NCT04502849|Diagnostic Test|Blood sampling|Blood sampling for apoptosis and endothelial dysfunction markers.
15793706|NCT04502849|Diagnostic Test|Arterial wall sampling|Arterial wall sampling for apoptosis markers.
15793707|NCT04502836|Behavioral|Preliminary psychological intervention|psychological intervention including providing knowledge and tools for problems solving according to the Choice - Agenda - Resilience - Emotional support (CARE) model . After intervention session patients and their parents will be asked to complete questionnaires
15793708|NCT04502823|Procedure|Management based on sFlt-1/PlGF values|"In women allocated to the intervention group, the sFlt-1/PlGF result will be revealed to the investigators that will act according to the results of sFlt/PlGF:
~Fetuses with sFlt-1/PlGF ≥38, elective delivery will be recommended at ≥37 weeks.
~Fetuses with sFlt-1/PlGF <38 weekly follow up will be recommended and delivery at ≥40 weeks."
15793709|NCT04502810|Radiation|High-level laser therapy|Nd:Yag 1064 nm pulsed high-level Laser will be applied to the vulvar area.
15793710|NCT04502797|Behavioral|Electronic Patient Visit Assessment (ePVA)|The ePVA is an mHealth clinical support tool. The ePVA consists of a patient-reported measure that focuses on symptoms common to HNC (i.e. pain, eye, ear, nasal, mouth, voice, fibrosis, edema, skin, gastrointestinal, fatigue, limitation in movement, sleep, breathing, difficulty eating or drinking, swallowing, communication, social activities, anxiety, depression, and daily activities). PROMIS® questionnaires (pain intensity 3a, fatigue 6a, sleep disturbance 6a, anxiety 6a, depression 6a) are embedded within the ePVA.
15793712|NCT04502758|Device|MagVenture TMS Therapy System w/Theta Burst Stimulation|During each session continuous theta burst stimulation (cTBS) in which 1800 pulses are delivered continuously over 120 seconds to the right dorsolateral prefrontal cortex (RDPFC) is administered first, followed by iTBS in which 1800 pulses are delivered in 2 second bursts, repeated every 10 seconds for 570 seconds (1800 pulses) to the left dorsolateral prefrontal cortex (LDPFC). The device consists of a magnetic stimulator, MagPro X100 and a magnetic coil used for MT determination, C-B70 and a treatment coil, the Cool-B70 A/P coil. The A/P version of the coil, contains both an active site (A) and a sham (P) site. The magnetic field properties on the active site are identical to that of the standard Cool-B70 coil, cleared for iTBS treatment.
15793713|NCT04502758|Device|Sham MagVenture TMS Therapy System w/Theta Burst Stimulation|During each session continuous theta burst stimulation (cTBS) in which 1800 pulses are delivered continuously over 120 seconds to the right dorsolateral prefrontal cortex (RDPFC) is administered first, followed by iTBS in which 1800 pulses are delivered in 2 second bursts, repeated every 10 seconds for 570 seconds (1800 pulses) to the left dorsolateral prefrontal cortex (LDPFC). The device consists of a magnetic stimulator, MagPro X100 and a magnetic coil used for MT determination, C-B70 and a treatment coil, the Cool-B70 A/P coil. The A/P version of the coil, contains both an active site (A) and a sham (P) site. The magnetic field on the sham site is significantly reduced, and is less than 5% of that of the active site.
15793714|NCT04502745|Device|Minimally Invasive Cortical Access System (MICAS)|Temporary surgical tool that provides access to the sub-dural space through the cranium.
15793715|NCT04502732|Other|NSSM and GEBT|The time to half gastric emptying (T1/2) will be assessed via Gastric Emptying Breath Tests (GEBT) and Nuclear Scintigraphy of a Solid Meal (NSSM) at baseline, 2 months, and 6 months. This data will be collected from seven adult subjects, with obesity, who have recently received Endoscopic Bariatric and Metabolic Therapy.
15793716|NCT04502719|Diagnostic Test|Nutritional screening.|Nutritional screening with the RFH-NPT and LDUST questionnaires.
15793725|NCT04502680|Drug|Eribulin Mesylate|Eribulin mesylate 1.4mg/m2, administered intravenously on Days 1 and 8 of each 21 day cycle.
15793726|NCT04502667|Drug|Cholecalciferol|1000U or 2000U every 24 hours orally
15793727|NCT04502654|Device|Actiwatch 2 (Philips Respironics, Murrysville, USA)|Actiwatch 2 is an unobtrusive, waterproof, light sensor and wrist-worn device (weight 16.0g, size 4.3 cm* 2.3 cm* 1.0 cm), containing a tri-axial accelerometer able to records a digitally integrated measure of gross motor activity (a piezoelectric sensor to detect vertical accelerations at the wrist between 0.5 and 2.0 g with a frequency response range between 0.35-7.5 Hz). Activity counts from the device reflect the peak acceleration detected over each epoch and are used in determining sleep and wake intervals, which can be used to rest-activity patterns, quality of physical activity and sleep for 15-60 seconds/ epoch, 24 hours/ day, 2 weeks.
15793728|NCT04502641|Drug|Docetaxel|60mg/m2 on day 1, 3 weeks as one cycle, for 3 cycles.
15793729|NCT04502641|Drug|5-fluorouracil|600 mg/m² per day as a continuous 120 h infusion on days 1-5, 3 weeks as one cycle, for 3 cycles.
15793730|NCT04502641|Drug|Cisplatin|60mg/m2 on day 1, 3 weeks as one cycle, for 3 cycles.
15793731|NCT04502641|Radiation|Intensity Modulated Radiation Therapy|The treatment consisted of definitive radiotherapy with conventional fractionation, a total dose of 68-70 Gy to PTVp, 62-68 Gy to PTVn, 60-62 Gy to PTV-HR, and 50-54 Gy to PTV-LR.
15793732|NCT04502641|Drug|Platinum|100mg/m2 on day 1, 3 weeks as one cycle, during radiotherapy.
15793733|NCT04502628|Procedure|Hyperbaric oxygen therapy|Patients with hemorrhagic cystitis (HC) after allo-HSCT will receive hyperbaric oxygen therapy (HBOT) on the next day of the HC diagnosis was determined. Then HBOT will be scheduled every day until symptoms of HC vanished. Other classic measures to treatment HC such as hydration, alkalization, and bladder irrigation will also be carried out at the same time.
15793734|NCT04502615|Other|Sand|sand surface
15793735|NCT04502615|Other|artificial grass|grass surface
15793736|NCT04502615|Other|firm ground|firm surface
15793737|NCT04502602|Drug|Neratinib 160 mg|Escalating doses to determine recommended phase 2 dose (RP2D)
15793738|NCT04502602|Drug|Neratinib 200 mg|Determined RP2D dose
15793739|NCT04502602|Drug|Neratinib 240 mg|Escalating doses to determine recommended phase 2 dose (RP2D)
15793740|NCT04502602|Drug|Niraparib 100 mg|Escalating doses to determine recommended phase 2 dose (RP2D)
15793741|NCT04502602|Drug|Niraparib 200 mg|Escalating doses to determine recommended phase 2 dose (RP2D)
15793742|NCT04502602|Drug|Niraparib 300 mg|Phase 1: Escalating doses to determine recommended phase 2 dose (RP2D)
15793743|NCT04502602|Drug|Niraparib at RP2D|Phase 1b: Determined dose
15793744|NCT04502602|Drug|Neratinib at RP2D|Phase 1b: Determined dose
15793745|NCT04502589|Drug|Perampanel Tablet|Subjects will be titrated over 3 weeks to a target dose of 8mg perampanel daily in both groups
15793747|NCT04502576|Device|Noninvasive respiratory support|"In both arms, the treatment according to the assigned protocol will be continued until the patient requires endotracheal intubation or (in case of no intubation) up to ICU discharge.
~Patients will have to undergo the allocated treatment within 1 hour from the moment of randomization and within 24 hours from admission in the intensive care unit"
15793748|NCT04502563|Other|Remote monitoring and predictive analytics|Subjects will undergo remote monitoring, remote monitoring data will be analyzed on a predictive platform, alerts indicating HF worsening shared with treating team, and algorithmic response to alerts implements.
15793749|NCT04502563|Other|Sham comparator|Subjects will wear a sensor, but data from the sensor will not generate alerts and will not be shared with the treating team.
15793750|NCT04502550|Drug|Propofol|Target effect-site concentration of propofol will be started at 1.4 μg/mL and will be increased by 0.3 μg/mL with reassessment until endpoints are achieved.
15793751|NCT04502537|Drug|Roxadustat|Oral
15793752|NCT04502537|Drug|erythropoietin|injection
15793753|NCT04502524|Behavioral|Smoking Cessation Intervention (New website)|Complete the new website smoking cessation program
15793754|NCT04502524|Behavioral|Smoking Cessation Intervention (Standard of care website)|Complete the standard of care website smoking cessation intervention
15793755|NCT04502524|Behavioral|Health Education|Receive information about the cost of smoking, benefits of quitting, ways to prepare for quitting, ways to handle triggers and withdrawal symptoms, and available medications to help with quitting. And will receive additional resources available at the VA handout via email at the end of the study.
15793756|NCT04502524|Other|Health Promotion and Education|Receive motivational and reminder text messages
15793757|NCT04502524|Other|Questionnaire Administration|Ancillary studies
15793758|NCT04502511|Diagnostic Test|Standard diagnosis test|Care as usual
15793759|NCT04502498|Diagnostic Test|Lower limb duplex & doppler|Lower limb duplex and doppler one week before radical cystectomy
15793760|NCT04502485|Procedure|Gastric water exchange|Upon entering the fundus of the stomach the air button will be turned off. Air pocket and gastric fluids will be removed by suctioning. Distilled water, delivered by a 50-ml syringe in 10ml-to-20 ml increments, will be infused to dislodge debris and air bubbles adhering the gastric mucosa and open the lumen. The infused water will be removed to keep the lumen almost completely collapsed before the scope advance further.
15793761|NCT04502485|Procedure|traditional air insufflation|Air will be minimally insufflated and residual fluid suctioned during the entire insertion process. Usually, no water will be infused to cleanse the mucosa until the withdrawal phase.
15793762|NCT04502472|Biological|Convalescent plasma transfusion|Transfusion of COVID-19 convalescent plasma to participants currently hospitalized with COVID-19 infection with severe or life-threatening clinical syndrome.
15793763|NCT04502459|Procedure|Tourniquet|A tourniquet is often used in total knee arthroplasty to achieve better visualization, reduce intra-operative bleeding and facilitate cement interdigitation
15793764|NCT04502446|Biological|CTX130|CTX130 CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components.
15793765|NCT04502433|Drug|CUROSURF® (poractant alfa)|"Three administrations with a 24 hours dosing interval.
~Each ET administration 1, 2, and 3 will consist of poractant alfa bolus:
~30mg /kg (Lean Body Weight-LBW) = 0.375ml /kg LBW. Dilution with normal saline up to 2ml /kg LBW"
15793766|NCT04502420|Diagnostic Test|Lung function before and after surgery|A diagnostic test
15793767|NCT04502407|Radiation|Cisplatin-based Radiation Therapy|"High risk patients who are patients with positive margins, extranodal extension, or ≥5 positive lymph nodes will receive radiation dose of 50 Gy in 25 fractions over 5 cycles on Days 1, 8, 15, 22, and 29 of radiation treatment.
~All other patients will receive radiation dose of 30 Gy in 15 fractions over 3 cycles on Days 1, 8 and 15 of radiation treatment."
15793768|NCT04502407|Drug|Cisplatin Chemotherapy|"High risk patients who are patients with positive margins, extranodal extension, or ≥5 positive lymph nodes will receive 5 cycles of weekly chemotherapy of cisplatin 40mg/m2 given intravenously (IV) on Days 1, 8, 15, 22, and 29 of radiation.
~All other patients will receive 3 cycles of weekly chemotherapy of cisplatin 40mg/m2 given intravenously (IV) on Days 1, 8 and 15 of radiation."
15793769|NCT04502394|Drug|KRT-232|KRT-232 is an experimental MDM2 inhibitor anticancer drug taken by mouth
15793770|NCT04502394|Drug|acalabrutinib|acalabrutinib is a BTK inhibitor anticancer drug taken by mouth
15793771|NCT04502381|Drug|Inhaled amp B deoxycholate+intravenous liposomal amp B|"Intravenous liposomal amphotericin B (beginning with 3mg/kg) along with inhaled amphotericin as below: Amp-B deoxycholate 50 mg (Amphotret™ Bharat serums and vaccines limited), will be dissolved in 10 mL distilled water. 2 mL of the reconstituted amphotericin B solution will be transferred into the drug chamber of a breath actuated nebulizer (Lupineb Ultra kit breath actuated nebulize which contains aeroclipse XL Reusable Breath Actuated Nebulizer and DeVilbiss 3655 compressor). 3 mL of distilled water is added to 2 mL of the reconstituted amphotericin B. The nebulization is continued till the chamber is emptied of the drug or the patient does not tolerate the therapy.
~The first three doses of amphotericin B nebulization will be under the direct supervision of a physician. If tolerated, nebulization will be continued twice a day till tolerated or till response.The patient will complete a VAS score for cough after nebulization."
15793772|NCT04502381|Drug|Intravenous liposomal amphotericin B alone|Intravenous liposomal amphotericin B (beginning with 3mg/kg, up to 5 mg/kg), with or without surgery or other antifungals as clinically indicated
15793773|NCT04502368|Procedure|Fiberoptic Bronchoscopy (FOB)|FOB under full sedation (RASS sedation scale -5) and full paralysis.
15793774|NCT04502368|Procedure|Bronchoalveolar Lavage (BAL)|BAL under full sedation (RASS sedation scale -5) and full paralysis. Lavage: NaCl 0,9% 50ml x 3 in lung region targetted according to RX/CT scan.
15793775|NCT04502368|Diagnostic Test|Electrical Impedance Tomography (EIT)|Realtime thoracic impedance coupled with ventilation parameters recording.
15793776|NCT04502368|Diagnostic Test|Arterial Blood Gas test (ABG)|Multiples Arterial Blood Gas test (ABG) via arterial catheter.
15793777|NCT04502342|Combination Product|Hydroxycloroquine and Azythromycine|dual treatment with Hydroxycloroquine and Azythromycine
15793778|NCT04502342|Combination Product|Cospherunate/Azythromycine|dual treatment with Cospherunate and Azythromycine
15793779|NCT04502342|Combination Product|Cospherunate/Phytomedicine/Azythromycien|triple treatment with Cospherunate, Asen and Azythromycine
15793782|NCT04502303|Diagnostic Test|18F-FDG and 68Ga-FAPI PET/CT|Participants will undergo 18F-FDG (0.12-0.15mCi/kg) and 68Ga-FAPI (3-6mCi) PET/CT on two consecutive days. At least 6 hours of fast is required for 18F-FDG PET scan, while no dietary control is necessary for 68Ga-FAPI PET scan. If the patients are on metformin, discontinuation of 48 hours is required before 18F-FDG injection to minimize the bowel uptake. If the patient is planned for surgical resection of one or more stricture (s), the scans have to be completed within a maximum period of 30 days before the surgery.
15793783|NCT04502290|Device|Combined Non-invasive brain stimulation and functional electrical hand stimulation|Participants will receive synchronously combined non-invasive brain stimulation (delivered via electrical/magnetic stimulation) with functional electrical stimulation (delivered via DS7A or Neuromove) of the weak hand
15793784|NCT04502277|Drug|Fluconazole Powder|The Objective of This Study Was an Open-label, Randomized, 2-way Crossover to Compare the Single-dose Relative Bioavailability of Diflucan 40mgm/ml 35 ml Suspension and to measure AUC at 0, 1 , 4 , 8, 12, 16 , 20 and 24 hours Under Fed Condition
15793785|NCT04502264|Device|Hand of Hope|A virtual reality (VR)-based, electromyography (EMG)-driven, and task-oriented hand robot.
15793786|NCT04502264|Drug|Botulinum toxin type A injection|A safe agent representing the gold standard treatment for focal spasticity.
15793787|NCT04502251|Drug|Low-Dose Naltrexone|4.5mg daily dose, orally, during 26 days
15793788|NCT04502251|Device|Transcranial Direct Current Stimulation|An anodal electrode was placed on the scalp above the primary motor cortex (M1), contralateral to the dominant cortex. The cathodal electrode was placed on the supraorbital contralateral area. The current used was 2mA during 20 minutes.
15793789|NCT04502251|Drug|Placebo|The capsule presented the same format, size and color as LDN capsules, however the excipient used was starch.
15793790|NCT04502251|Device|Sham Transcranial Direct Current Stimulation|Sham-tDCS stimulation consists of an active current during 30 seconds
15793791|NCT04502238|Other|Fluid restriction|Study participants will refrain from drinking fluids overnight to facilitate 1-2% fluid loss from baseline
15793792|NCT04502225|Other|Tilt|Tilt of the whole bed so that the head is elevated by 9 and/or 12 inches in an acute trial or overnight.
15793793|NCT04502225|Other|Elevated trunk|Elevation of the trunk through raising just the head of the bed until the head is elevated by 9 and/or 12 inches in an acute trial or overnight.
15793794|NCT04502225|Other|Tilt - In home|Tilt of the whole bed so that the head is elevated by 8 inches overnight.
15793795|NCT04502225|Other|Elevated Trunk - In home|Elevation of the trunk through raising the head 8 inches on a wedge pillow overnight.
15793796|NCT04502212|Device|Hepatic Ultrasound Insonification|Hepatic ultrasound insonification will be performed after an overnight fast (no food or drinks except for water for at least 10 hours) at approximately the same time on each day for three days.
15793797|NCT04502199|Other|non interventional study|observational study
15793798|NCT04502186|Behavioral|Raising Our Spirits Together|Raising Our Spirits Together (ROST) is an 8-session computer-assisted cognitive behavioral therapy for depression. Core CBT content, including behavioral activation, cognitive restructuring, and problem solving, are delivered via the computer-assisted platform using video and text-based elements. The computer-assisted intervention is complemented by a workbook that includes in-session exercises as well as homework/action plans. ROST is delivered weekly, either virtually or in-person at a local church, and facilitated by a local pastor.
15793799|NCT04502186|Other|Enhanced Control Condition|The Enhanced Control Condition intervention consists of providing participants randomized to this condition with a self-help book for depression (The Depression Helpbook; Katon et al, 2008) that is widely used and found to be beneficial, a local resource guide, and referrals.
15793800|NCT04502173|Device|Ellavi UBT|The study team will train all obstetric healthcare staff (i.e. obstetricians, midwives, medical officers, clinical officers) involved in PPH management at the participating healthcare facilities on use of the Ellavi UBT. This will be done to gather feedback from the healthcare workers (post-training and post-PPH) to understand the barriers to and facilitators of use in order to evaluate acceptability and feasibility among facilities providing different levels of care (level 4, level 5 (county), level 6 (tertiary)).
15793801|NCT04502160|Procedure|Vascular Access Creation|arteriovenous fistula creation
15793802|NCT04502147|Procedure|Laparoscopic Splenectomy|Laparoscopic splenectomy by ligating the splenic artery
15793803|NCT04502121|Behavioral|EXPECT: Preoperative optimization of cardiac valve patient's expectations|The psychological, preoperative intervention follows a treatment manual. Patients get a personal intervention one day before surgery (30-40 minutes). It includes the development of an individual, subjectively perceived disease model, the treatment outcome expectations and the personalized outcome expectancy. Additionally they get two booster telephone calls 4 and 8 weeks after the surgery to recall the discussed topics and to talk about their recovery process (10-15 minutes).
15793804|NCT04502108|Behavioral|Covid19|Impact of the COVID19-pandemic on physical activity, nutritional habits and sleeping behavior during an extraordinary period of confinement and social distancing, during the loosening phase and social distancing and the phase after the pandemic.
15793805|NCT04502095|Drug|Clindamycin|Given PO
15793806|NCT04502095|Other|Diary|Complete drug diary
15793807|NCT04502095|Drug|Ertapenem|Given PO
15793808|NCT04502095|Drug|Levofloxacin|Given PO
15793809|NCT04502095|Drug|Nitrofurantoin|Given PO
15793810|NCT04502095|Drug|Trimethoprim-Sulfamethoxazole|Given PO
15793811|NCT04502082|Biological|ET140203 autologous T cell product|Autologous T cells transduced with lentivirus encoding an ET140203 expression construct
15793812|NCT04502069|Drug|Opaganib|500 mg Q12 hours orally
15793813|NCT04502056|Behavioral|Acknowledgement Racial Injustice AMA|Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants will receive a AMA statement on racial injustice.
15793814|NCT04502056|Behavioral|African American Sender Acknowledgement|Investigators will also vary the messenger of the acknowledgement sender. In this arm participants receive a African American sender in acknowledgment of AMA
15793815|NCT04502056|Behavioral|African American Sender in Informational Videos.|Investigators will vary the sender of the informational covid-19 videos. In this arm, participants receive a African American sender in informational videos.
15793816|NCT04502056|Behavioral|Racial Inequality Highlighted|Investigators will include information on race-specific covid-19 cases and deaths in one variation in the messaging. In this arm, participants receive disproportionate race-specific Covid-19 facts
15793817|NCT04502056|Behavioral|AMA Acknowledgement Drug Pricing|Investigators will examine whether acknowledgements of racial inequality are helpful towards improving knowledge retention and behaviors associated with the intervention among participants. In this arm, participants receive AMA information on drug pricing
15793818|NCT04502056|Behavioral|White Sender in Acknowledgement|Investigators will also vary the messenger of the acknowledgement sender. In this arm, participants receive a white sender in the acknowledgement
15793819|NCT04502056|Behavioral|White Sender in Informational Videos|Investigators will vary the messenger of the informational covid-19 videos. In this arm, participants receive white sender in the informational video
15793820|NCT04502056|Behavioral|No Racial Inequality Highlighting|In this arm, the disproportionate burden of Covid-19 on communities of color will not be highlighted
15793821|NCT04502056|Behavioral|Placebo videos|Videos not related to covid-19 will be shown
15793822|NCT04502043|Other|Exercise therapy|"Education
~Hip-specific strengthening exercises
~Functional lower limb strengthening exercises
~Core stability exercises
~Postural balance exercises"
15793823|NCT04502030|Biological|Panzyga|Panzyga is a 10% IVIG produced from a pool of human fresh frozen plasma donations
15793824|NCT04502030|Other|Placebo|Placebo
15793825|NCT04502017|Drug|ASA plus Clopidogrel|OAC (6 weeks) + DAPT (until 6 months) + ASA
15793826|NCT04502017|Drug|Genetic-Tailored AntiThrombotic Strategy|Half-Dose OAC or Clopidogrel in combination with ASA on the basis of CYP2C19 Genotype
15793827|NCT04502017|Drug|Half-Dose of novel OAC|Half Dose of novel OAC post-device Implantation
15793828|NCT04502004|Device|App for health=mhealth|Cognitive-Behavioural Therapy and Clinical Practice Guide that recommends 5 Aes: Ask about tobacco, Advise smoking cessation, Assess tobacco consumption, Assist and Arrange (Fiore et alt., 2008)
15793829|NCT04501991|Other|antidiabetic treatment|Every kind of antidiabetic treatment, oral or injective, were considered including patients treated only with diet
15793838|NCT04501965|Combination Product|Hydroxychloroquine/Azithromycine|Dual treatment with Hydroxychloroquine and Azythromycin
15793839|NCT04501965|Combination Product|Quinquina-Stevia/Azythromycin|Dual treatment with Quinquina/Stevia (3/0,5) and Azythromycin
15793840|NCT04501965|Combination Product|4Plants/Azythromycin|Dual treatment with 4 plant species drug and Azythromycin
15793841|NCT04501952|Drug|RDV|Administered as an intravenous infusion
15793842|NCT04501952|Drug|Placebo to Match RDV|Administered as an intravenous infusion
15793843|NCT04501939|Drug|Cirmtuzumab|Cycle 1, Day 1 & 15 - 600mg Cycle 2, Day 1 to Cycle 6, Day 1 - 600mg
15793844|NCT04501939|Drug|Venetoclax|Venetoclax 400mg PO daily from cycle 1 day 1 for 6 cycles of 28 days.
15793845|NCT04501913|Procedure|Patient Monitoring|Undergo remote perioperative telemonitoring
15793846|NCT04501913|Other|Questionnaire Administration|Complete questionnaires
15793847|NCT04501900|Drug|Clopidogrel|Study subjects diagnosed as stable, unstable ischemic coronary disease or myocardial infarction planning to undergo percutaneous coronary intervention (PCI) and no contradiction to prolonged DAPT are eligible for this trial. All subjects will provide written informed consent to participate. Subjects will be enrolled into the study before or within 24 hours after the index procedure. Subjects will be randomized to either discontinue P2Y12 inhibitor (clopidogrel or ticagrelor) (12 months total) or receive P2Y12 inhibitor for an additional 24 months (36 months total). Aspirin will be maintained in the entire study and can be replaced by cilostazol or indobufen if subjects are intolerant. Dosage of antiplatelet drugs will be according to local standard of practice. Subjects will be treated with XINSORB BRS only.
15793848|NCT04501874|Drug|EMB-001|720 mg metyrapone/24 mg oxazepam mg BID
15793849|NCT04501874|Drug|EMB-001 Placebo|Inactive comparator
15793850|NCT04501861|Drug|Norepinephrine|Hemodynamic effect of norepinephrine on the pulmonary circulation in cardiac surgery patients
15793851|NCT04501861|Drug|Vasopressin|Hemodynamic effect of vasopressin on the pulmonary circulation in cardiac surgery patients
15793852|NCT04501848|Procedure|adenotonsillectomy|adenotonsillectomy surgery
15793853|NCT04501835|Other|Diagnostic and treatment evaluation|No intervention, description of the diagnostic evaluation and the treatment
15793854|NCT04501822|Diagnostic Test|Evaluation of clinical, instrumental and laboratory diagnostics tests|During follow-up visits patients undergo clinical, instrumental and laboratory diagnostics tests
15793855|NCT04501809|Procedure|compare misoprostol with combined oxytocin and cervical foly catheter|we will compare using misoprostol alone in one group with oxytocin and cervical catheter in the other group
15793856|NCT04501796|Drug|Double-Blind NT-I7|Administered by intramuscular (IM) injection
15793857|NCT04501796|Drug|Double-Blind Placebo|Placebo
15793858|NCT04501783|Drug|Favipiravir|TL-FVP-t will be administered orally
15793859|NCT04501783|Drug|Standard of care (SOC)|SOC will include standard etiotropic therapy (umifenovir + intranasal recombinant interferon alpha, or hydroxychloroquine, or chloroquine) according to MoH of Russian Federation recomendations for COVID-19
15793860|NCT04501783|Drug|standard concomitant therapy|Standard of care according to MoH of Russian Federation recomendation for COVID-19
15794002|NCT04500678|Drug|Metformin|Metformin 500 mg Extended Release (ER) qd increasing to 1000 mg ER qd at week 4 and continued to week 48.
15793861|NCT04501770|Drug|Chort 1 of M802|Cohort 1, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 2 μg, and the maintenance dose during core treatment period and extended treatment period is 5 μg.
15793862|NCT04501770|Drug|Chort 2 of M802|Cohort 2, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 5 μg, and the maintenance dose during core treatment period and extended treatment period is 10 μg.
15793863|NCT04501770|Drug|Cohort 3 of M802|Cohort 3, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 10 μg, and the maintenance dose during core treatment period and extended treatment period is 20 μg.
15793864|NCT04501770|Drug|Cohort 4 of M802|Cohort 4, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 20 μg, and the maintenance dose during core treatment period and extended treatment period is 50 μg.
15793865|NCT04501770|Drug|Cohort 5 of M802|Cohort 5, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 50 μg, and the maintenance dose during core treatment period and extended treatment period is 100 μg.
15793866|NCT04501770|Drug|Cohort 6 of M802|Cohort 6, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 100 μg, and the maintenance dose during core treatment period and extended treatment period is 150 μg.
15793867|NCT04501770|Drug|Cohort 7 of M802|Cohort 7, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. Dose on D1 is 150 μg, and on D8, D15, D22 is 225 μg.
15793868|NCT04501770|Drug|Cohort 8 of M802|Cohort 8, subjects will be administered M802 via intravenous infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. The starting dose is 225 μg, and the maintenance dose during core treatment period and extended treatment period is 300 μg.
15793869|NCT04501757|Biological|Naxitamab/GM-CSF|naxitamab/GM-CSF for 5 Cycles
15793870|NCT04501744|Drug|Cohort 1 of M701|Patients in Cohort 1 will receive 4 escalating doses (2, 5, 10 and 25 μg) of M701 on Days 1, 8, 15 and 22. The maintenance dose during extended treatment period is 25 μg.
15793871|NCT04501744|Drug|Cohort 2 of M701|Patients in Cohort 2 will receive a starting dose on Day 1 and three infusions at a higher maintenance dose level on Days 8, 15 and 22. The starting dose is 25 μg, and the maintenance dose during core treatment period and extended treatment period is 50 μg.
15793872|NCT04501744|Drug|Cohort 3 of M701|Patients in Cohort 3 will receive a starting dose on Day 1 and three infusions at a higher maintenance dose level on Days 8, 15 and 22. The starting dose is 50 μg, and the maintenance dose during core treatment period and extended treatment period is 100 μg.
15793873|NCT04501744|Drug|Cohort 4 of M701|Patients in Cohort 4 will receive a starting dose on Day 1 and three infusions at a higher maintenance dose level on Days 8, 15 and 22. The starting dose is 100 μg, and the maintenance dose during core treatment period and extended treatment period is 200 μg.
15793874|NCT04501744|Drug|Cohort 5 of M701|Patients in Cohort 5 will receive a starting dose on Day 1 and three infusions at a higher maintenance dose level on Days 8, 15 and 22. The starting dose is 150 μg, and the maintenance dose during core treatment period and extended treatment period is 300 μg.
15793875|NCT04501744|Drug|Cohort 6 of M701|Patients in Cohort 6 will receive a starting dose on Day 1 and three infusions at a higher maintenance dose level on Days 8, 15 and 22. The starting dose is 200 μg, and the maintenance dose during core treatment period and extended treatment period is 400 μg.
15793876|NCT04501744|Drug|Cohort 7 of M701|Patients in Cohort 7 will receive a starting doseon Day 1 and three infusions at a higher maintenance dose level on Days 8, 15 and 22. The starting dose is 250 μg, and the maintenance dose during core treatment period and extended treatment period is 500 μg.
15793877|NCT04501731|Other|Transcranial Magnetic Stimulation (TMS)|With the TMS session we gather information about nerve fibres from the brain to the hand. It will last around 2 hours and 30 minutes.
15793878|NCT04501731|Other|Magnetic Resonance Imaging (MRI)|With the MRI scan we will gather information about the brain structure and function. This will last around 30 minutes.
15793879|NCT04501731|Other|Motor assessment|"The motor assessment includes a pegboard game, a grab the alien nose game and measure of your maximum grip force. In total it will last around 30 minutes."
15793880|NCT04501731|Other|Questionnaires|Feasibility, tolerability of such intervention as well as quality of life of PFT survivors will be assessed thanks to questionnaires.
15793881|NCT04501718|Drug|Apatinib Combined With Temozolomide and Etoposide Capsules|"Apatinib mesylate tablets: Oral, 250mg, qd. Take the medicine with warm water half an hour after a meal (the daily medicine should be taken at the same time as possible).
~28 days is a cycle, and the medication is administered until the disease progresses (PD), intolerable toxicity occurs or the patient withdraws informed consent. The longest period does not exceed 12 cycles. The treatment after 12 cycles is determined by the investigator."
15793882|NCT04501705|Drug|Apatinib Mesylate|"Apatinib mesylate tablets: Orally, 500 mg, once a day, with warm water for half an hour after a meal (the time of taking the medicine every day should be the same as possible).
~Continue to use 28 days as a cycle, medication until disease progression (PD), intolerable toxicity occurs or the patient withdraws informed consent. However, the longest period does not exceed 24 cycles, and the treatment after 24 cycles is determined by the investigator."
15793883|NCT04501692|Procedure|VivaSight|see above
15793884|NCT04501692|Procedure|Videolaryngoscopy|see above
15793885|NCT04501679|Drug|Nemolizumab|Participants will receive either 30 mg or 60 mg dose of nemolizumab as SC injection.
15793886|NCT04501679|Drug|Placebo|Participants will receive matching placebo as SC injection.
15793887|NCT04501666|Drug|Nemolizumab 30 mg|Participants will receive either 30 mg or 60 mg dose of nemolizumab as SC injection.
15793888|NCT04501666|Drug|Placebo|Participants will receive matching placebo as SC injection.
15793999|NCT04500704|Drug|Almonertinib|Almonertinib 110mg PO once daily. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
15793889|NCT04501653|Drug|Psilocybin|Psilocybin is a naturally occurring psychedelic compound produced by psilocybin mushrooms, and has been shown to have antidepressant and anti-anxiety effects after one dose of 25 mg. Common side effects are slight elevations in blood pressure and heart rate. Participants will be randomized to receive either psilocybin or control at two separate imaging timepoints in this study.
15793890|NCT04501653|Drug|Methylphenidate|Methylphenidate is a stimulant medication used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy, and is used as an active control for this study because it is metabolized similarly to psilocybin and has similar effects on heart rate and blood pressure. Participants will be randomized to receive either psilocybin or control at two separate imaging timepoints in this study.
15793895|NCT04501601|Dietary Supplement|Fruit and vegetable solid drink|weight loss program supplement
15793896|NCT04501588|Behavioral|Responsive training with no video feedback|Parents will receive responsive training, but will not watch themselves on video to reflect on their strategy use.
15793897|NCT04501588|Behavioral|Responsive training with video feedback|Parents will receive responsive training and watch themselves on video to reflect on their strategy use.
15793898|NCT04501575|Other|Osteopathic Consultation|A consultation including case history taking, physical assessment, osteopathic manual treatment, exercise prescription, and postural advice.
15793899|NCT04501575|Other|Sham Osteopathic Consultation|A sham treatment using light touch on bony structures, no diagnosis, advise or prescriptions
15793900|NCT04501562|Other|Examinations|Participants will undergo focused examinations that include measurement of height, weight, waist circumference, body composition analysis, baseline data collection and blood pressure examinations. Resting electrocardiography will be performed to ascertain sinus rhythm.
15793901|NCT04501562|Other|Cardiovascular Tests|Specific quantitative cardiac ageing-related outcome parameters will be examined by multimodal techniques including two-dimensional transthoracic echocardiogram, and/or non-contrast magnetic resonance imaging/magnetic resonance spectroscopy.
15793902|NCT04501562|Other|Bio-specimen collection|Bio-specimens collected will include fresh blood, urine and/or stool specimens.
15793903|NCT04501562|Other|Clinical/health outcome collection|Health status will be tracked by telephone follow-up and/or matching at national disease registries at periodic intervals within one to five years, up to three decades.
15793904|NCT04501549|Procedure|percutaneous coronary intervention|PCI will be performed according to local practice.The bifurcation lesion will be imaged by OCT on at least two time-points for each patient. Plaque morphology will be characterized by OCT. Off-line quantitative coronary angiography (QCA) will be performed before and after PCI and the following QCA parameters will be computed: reference vessel diameter (RVD), lesion length and diameter stenosis (DS) of Main Vessel (MV) and side branch (SB). Blood samples will be taken prior to PCI and 8-12 hours later to determine peri-procedural myocardial injury and infarction following PCI by measuring serum Troponin.
15793905|NCT04501536|Behavioral|Word Learning Intervention|The word learning intervention uses the 10 commercially available children's books and 6 target vocabulary words from each book that meet common criteria for appropriate vocabulary targets. Children will receive 1-on-1 treatment sessions with a trained, speech-language research assistant. Each week, 2 of 10 storybooks chosen for the study will be read with 3 of 6 targeted vocabulary words targeted from each book. The book and words targeted will be consistent between random assignment conditions. For each book reading, speech-language interns will implement word learning strategies during pre reading, during reading, and post reading. Strategies include providing a definition, a synonym, and a contextual sentence. The number of strategies used will vary on which word is being targeted; all words will be randomly assigned to a particular dose, ranging from 0 (no strategies) to 20 (all of the strategies at each reading).
15793906|NCT04501523|Drug|Tislelizumab|200mg, q3w, for 1 year
15793907|NCT04501523|Drug|capecitabine|600-750 mg/m2 PO Bid，continuous, for 1 year
15793908|NCT04501510|Diagnostic Test|Ultrasonographic examination validation and testing|X-ray imaging as well as the ultrasonographic examination of the fracture and healing process in children will be performed. The validation of an usg will be done.
15793909|NCT04501484|Procedure|Magnetic Resonance-guided Focused Ultrasound VIM Thalamotomy|Ablation of contralateral VIM nucleus of thalamus with MRgFUS using ExAblate Neuro 4000 Device (InSightec Ltd, Tirat Carmel, Israel)
15793910|NCT04501471|Behavioral|SAAF-T|Parents and youth meet separately during first hour to engage in activities then meet in family groups during the second hours of each session.
15793911|NCT04501471|Behavioral|Fuel for Families|Parents and youth meet separately during first hour to engage in activities then meet in family groups during the second hours of each session.
15793912|NCT04501458|Other|Training of youth, community health assistants and community health workers.|Training of youth, community health assistants, and community health workers in the screening, detection, contact tracing, prevention, and management of COVID-19 with concurrent maintenance of essential health services.
15793913|NCT04501458|Other|Training clinicians in basic critical care and the management of severe COVID-19 cases|Training clinicians in basic critical care and the management of severe COVID-19 cases with concurrent maintenance of essential health services.
15793914|NCT04501445|Behavioral|Written Summary of Rounds|The summary was organized as follows for each of the most important ICU problems: 1) Description of the problem, 2) Ways the ICU team is addressing the problem i.e. consultations, diagnostic tests, and treatments. 3) An assessment of whether the problem is improving or worsening.
15793916|NCT04501419|Procedure|US-guided breast biopsy|During this study, women with undergo an US-guided breast biopsy by a radiologist instead of what is typically performed in Nigerian hospitals, which is either a blind biopsy or surgical excision. US-guided breast biopsy is the standard of care in the United States of America because the accuracy is better than blind biopsy and equal to surgical excision.
15793917|NCT04501419|Other|Ultrasound-guided breast biopsy training program|This program, developed by experts in Nigeria and the United States of America, certifies that they have the skills required to safely perform these biopsies on patients
15793918|NCT04501406|Drug|Pioglitazone|An insulin-sensitizer FDA-approved to treat hyperglycemia caused by type 2 diabetes.
15793919|NCT04501406|Other|Placebo|Placebo looks just like pioglitazone and is given in the same way but has no active drug in it.
15793920|NCT04501393|Other|Clear liquid intake|Clear oral fluid including water, pulp-free juice and tea or coffee without milk
15793921|NCT04501380|Drug|AEMCOLO (Rifamycin SV MMX)|Participants will be issued a patient kit containing AEMCOLO (Rifamycin SV MMX) 194 mg tablets for the 1st or the 2nd treatment regimen in a random order.
15793922|NCT04501367|Drug|Dexamethasone Intracanalicular Insert, 0.4 mg|To determine post-surgical resolution of pain, inflammation, and cystoid macular edema outcomes when treated with one DEXTENZA (lower eye lid canaliculus) compared to topical steroid treatment in patients who undergo vitrectomy with internal limiting membrane peel surgery
15793923|NCT04501367|Drug|Dexamethasone Intracanalicular Insert, 0.4 mg|To determine post-surgical resolution of pain, inflammation, and cystoid macular edema outcomes when treated with two DEXTENZA (upper and lower canaliculi) compared to topical steroid treatment in patients who undergo vitrectomy with internal limiting membrane peel surgery
15793924|NCT04501367|Drug|Prednisone acetate 1%|To reduce post-surgical pain and inflammation in patients who undergo vitrectomy with internal limiting membrane peel surgery
15793925|NCT04501354|Drug|Mesenchymal Stem Cell|Mesenchymal Stem Cell + NaCl 0,9% 2ml
15793926|NCT04501341|Biological|Bone-marrow aspiration, Intra-pancreatic Catheterisation of BM-MNC|Autologous bone-marrow mononuclear cells infused to the main blood vessels that supply the pancreas according to the results of previous pancreatic CT-scan, performed by interventional radiologist. The target is to distribute the BM-MNCs equally in all part of the pancreas. Dosage: 1 x 10^5 - 1 x 10^6 CD34 cells/kgBW
15793927|NCT04501341|Biological|Intravenous Infusion of UC-MSC|Allogeneic umbilical cord tissue-derived mesenchymal stem cells will be given via intravenous infusion. Dosage: 2 x 10^6 cells/kgBW, twice, with three months interval
15793928|NCT04501328|Behavioral|CIC+VA-CRAFT|CIC+VA-CRAFT consists of four 45-min. telephone coaching calls over 8-12 weeks, delivered by a coach following a manual, while participants are completing the VA-CRAFT for PTSD web-based course.
15793929|NCT04501328|Behavioral|CIC|Coaching Into Care is an existing national VA program that provides telephone consultation and coaching to family members of Veterans with mental health needs who want to help connect them with mental health care by providing referrals, educational information, and a unique coaching service to help callers talk to their Veterans about their decision to seek care.
15793930|NCT04501315|Diagnostic Test|Blood, cerebrospinal fluid and urine samples|In all subjects, blood (4 mL), cerebrospinal fluid (4mL) and urine (4mL) samples were collected daily as part of the clinical routine at 6:00 AM.
15793931|NCT04501289|Drug|Low dose magnesium sulphate|Participants in this arm will receive 4g of 20% intravenous (I.V.) MgSO4 (Magphate®) given over 10 minutes, followed by 3g of 50% intramuscular (I.M.) MgSO4 in each buttock statim. Then, maintenance doses will be given as 2.5g of 50% MgSO4 administered intramuscularly 4 hourly for 24 hours, for participants with severe preeclampsia and for 24 hours post delivery or post last seizure episode, whichever occurs last, for cohorts with eclampsia.
15793932|NCT04501289|Drug|Pritchard regimen|Participants in this arm will receive loading dose as 4g of 20% MgSO4 I.V. over 10 minutes, followed by 5g of 50% MgSO4 I.M. in each buttock. Maintenance doses will be given as 5g of 50% MgSO4 I.M. 4 hourly in alternate buttock until 24 hours for patients with eclampsia and for 24 hours after delivery or after last fit, whichever occurs later, for cohorts with eclampsia.
15793933|NCT04501276|Drug|ADG116|ADG116 will be administered IV over 60-90 minutes with planned doses every three weeks for the first 4 cycles. If no intolerable toxicities occur during the first consecutive four treatment cycles, administration of ADG116 may continue every 12 weeks for a total duration of up to 2 years per agreement with the Investigator and the Sponsor.
15793934|NCT04501263|Behavioral|DEMCoN Educational Intervention|Educational programme on constipation for Health care professionals in this clinical specialist palliative care
15793935|NCT04501250|Drug|Rinsulin NPH|subcutaneous injection at a dose of 0.4 IU/kg
15793936|NCT04501250|Drug|Humulin NPH|subcutaneous injection at a dose of 0.4 IU/kg
15793937|NCT04501237|Behavioral|Bruxers with sleep hygiene instructions|the test group will receive instructions of sleep hygiene, limited use of screens and a relaxation audio.
15793938|NCT04501224|Drug|Tenofovir alafenamide fumarate|Patients would take tenofovir alafenamide fumarate, 25mg，once per day
15793939|NCT04501224|Drug|Entecavir or Tenofovir disoproxil fumarate|Patients would take entecavir 0.5 mg once per day, or tenofovir disoproxil fumarate 300 mg once per day
15793940|NCT04501211|Drug|Granisetron|transdermal sancuso patch
15793941|NCT04501198|Device|moxibustion combined with characteristic lifestyle intervention of traditional chinese medicine|"The moxibustion acupoints will be selected as①zhongwan, guanyuan, shenque, and zusanli;②pishu,shenshu. Acupoints group①will be selected on Monday, Wednesday, and Friday, Acupoints group②will be selected on Tuesday, Thursday, Saturday.Moxibustion treatment will be applied once every day, 6 times per week, for 8 consecutive weeks.
~Xiusheng decoction, traditional exercises, and modern lifestyle intervention will be combined as the characteristic lifestyle intervention method of TCM to help participants establish healthy living habits. The Xiusheng Decoction should be taken twice a day. Traditional exercises will be taken for 35~40 minutes everyday, 7 times a week. The intervention of Xiusheng Decoction and traditional exercises will be conducted for 8 weeks. All patients will be instructed to follow a good living habits which will last 12 weeks including the treatment period of 8 weeks and the follow-up period of 4 weeks."
15794000|NCT04500704|Drug|Almonertinib plus carboplatin and pemetrexed|Almonertinib 110mg PO once daily in combination with pemetrexed (500 mg/m2) plus carboplatin (AUC=5) on Day 1 of 21day cycles (every 3 weeks) for 4-6 cycles, followed by Almonertinib daily with pemetrexed maintenance (500 mg/m2) every 3 weeks.
15794001|NCT04500691|Other|pain intensity reporting|pain intensity reporting
15793942|NCT04501198|Device|Moxibustion combined with lifestyle intervention.|"The moxibustion acupoints will be selected as①zhongwan, guanyuan, shenque, and zusanli;②pishu,shenshu. Acupoints group①will be selected on Monday, Wednesday, and Friday, Acupoints group②will be selected on Tuesday, Thursday, Saturday.Moxibustion treatment will be applied once every day, 6 times per week, for 8 consecutive weeks.
~All patients will be instructed to follow a good living habits including diet and exercise intervention which will last 12 weeks including the treatment period of 8 weeks and the follow-up period of 4 weeks."
15793943|NCT04501198|Device|lifestyle intervention|All patients will be instructed to follow a good living habits including diet and exercise intervention which will last 12 weeks including the treatment period of 8 weeks and the follow-up period of 4 weeks.
15793944|NCT04501185|Device|total hip arthroplasty|The indication for total hip arthroplasty is mainly osteoarthritis.
15793945|NCT04501172|Behavioral|Questionnaire completion|"Participants are contacted through social networks (Facebook) which provide a link to website that contains the questionnaire. Then, they complete the questionnaire which consists of the following 2 parts:
~participant's demographic characteristics with questions regarding age, visual acuity - refractive error, spectacles and contact lenses use, and compliance to mask-wearing directives.
~20 items that construct 5 subscales: a) near vision (5 items), b) distance vision (3 items), c) ocular discomfort (3 items), d) driving (2 items), e) limitations (3 items), need for help (2 items), work collaboration (1 item), and emotional impact (1 item).
~The impact of spectacles on the compliance of Greek people to mask-wearing directives will be assessed via this questionnaire."
15793946|NCT04501159|Other|blood sample pre, during and post HD|Assessment of ABG pre, during and post HD
15793947|NCT04501159|Device|Non invasive cardiac output assessment|Four ECG style electrodes are placed on the thorax which indirectly measures cardiac output.
15793948|NCT04501133|Device|Peripheral electrical stimulation|Electrical stimulation will be delivered to forearm muscles with an electrical stimulator (Digitimer Ltd., Hertfordshire, UK) so that they generate forces opposed to those arising from the tremorgenic input.
15793949|NCT04501133|Device|Single pulse TMS|Single-pulse TMS (spTMS) will be delivered with a TMS stimulator (MagPro X100 w/ MagOption, MagVenture, Farum, Denmark) and a figure-of-eight TMS coil. An MRI-based TMS navigation system will be used to navigate the TMS coil (Localite, St Augustin, Germany).
15793950|NCT04501120|Drug|APG-2575|APG-2575 orally once daily, every 28 days as a cycle.
15793951|NCT04501120|Drug|reduced-dose HHT|1mg IV QD on Days 1-14 (28-day cycle).
15793952|NCT04501120|Drug|standard-dose HHT|2mg/m^2 IV QD on Days 1-7 (28-day cycle).
15793953|NCT04501120|Drug|Azacitidine|75 mg/m^2 SC QD on Days 1- 7 (28-day cycle).
15793954|NCT04501107|Drug|Administration of BioChaperone insulin lispro reconstituted with Humalog® (IMP1)|Administration of IMP1 during a 12-hour euglycaemic clamp.
15793955|NCT04501107|Drug|Administration of Ready-to-use BioChaperone insulin lispro (IMP2)|Administration of IMP2 during a 12-hour euglycaemic clamp.
15793956|NCT04501107|Drug|Administration of US-approved Humalog® (IMP3)|Administration of IMP3 during a 12-hour euglycaemic clamp.
15793957|NCT04501107|Drug|Administration of EU-approved Humalog® (IMP4)|Administration of IMP4 during a 12-hour euglycaemic clamp.
15793959|NCT04501068|Device|Ambu® AuraGainTM|Evaluate the time of insertion, performance, security and insertion success rate of the Ambu® AuraGainTM in patients undergoing ambulatory surgery and general anaesthesia
15793960|NCT04501055|Behavioral|perineal nerve block|An anesthesia method to block perineal nerve
15793961|NCT04501055|Behavioral|periprostatic block|An anesthesia method to block periprostate
15793962|NCT04501042|Procedure|Bariatric surgery|Bariatric surgery
15793963|NCT04501029|Drug|Gimatecan|Patients will receive gimatecan orally at the recommended dose level on day 1-5 every 4 weeks.
15793964|NCT04501016|Behavioral|Tailored behavioral counseling|Participants will initially receive a six-session telephone intervention. Standard cognitive behavioral treatment strategies will be included. Participants will be screened for elevated depressive symptoms, risky alcohol use, and concerns about weight and and offered supplemental behavioral counseling related to these issues as appropriate. Those that are unable to quit tobacco initially will receive an enhanced, four-session counseling module focused on reduced scheduled smoking. Those who do quit tobacco use initially will receive four sessions of extended counseling based on positive psychology intervention strategies.
15793965|NCT04501016|Drug|Tobacco cessation pharmacotherapy|Pharmacotherapy will be selected based on medical and psychiatric history and potential interactions with other current medications combined with shared decision making. Options will include nicotine gum (2 and 4 mg), nicotine lozenge (2 and 4 mg), nicotine patch (7, 14, and 21 mg), bupropion (150 mg twice daily) and varenicline (1 mg twice daily). Monotherapy and combination therapy options will be provided.
15793966|NCT04501003|Device|Bipolar cutting electrode (26040 BL1 Karl Storz, Tuttlingen)|With the bipolar cutting electrode (26040 BL1 Karl Storz, Tuttlingen. Germany), a single incision was made from the bottom of the ostium onto the lateral walls up to the isthmus, with both lateral horns perpendicular to myometrium. The depth of the incision was between 5 and 7 mm. The cavity was widened to be triangular and symmetrical. Both tubal ostium surgeries were clearly observed at the end of the surgery. All patients were discharged on the day of surgery and no hormonal therapy and intrauterine balloon was applied after surgery. Approximately 3 months after the hysteroscopic T-shaped operation, an office hysteroscopy operation was planned to control patients in the secretory phase, to perform uterine cavity and post-operative fly control and to receive post-operative control endometrial biopsy specimens.
15793967|NCT04500990|Radiation|MRI test|Patients will receive diagnostic MRI test on d0.
15793968|NCT04500990|Radiation|MRI test|Patients will receive diagnostic MRI test on d8±1.
15793969|NCT04500990|Radiation|MRI test|Patients will receive diagnostic MRI test on d30±2.
15793970|NCT04500977|Behavioral|leadership empowerment|In the leadership program, women were taught more about the manner in which to bring about a change in one's health by adapting a healthy life style, leadership and facilitation skills and the development, implementation and evaluation process required to conduct a community program that will impact society. Women learned how to map needs and resources, define goals and objectives, develop, implement and evaluate a community based program.
15793971|NCT04500964|Device|TAVR|Trancatheter aortic valve replacement
15794003|NCT04500665|Drug|Colchicine|Colchicine
15793972|NCT04500951|Other|Optimized resting environment|"Alarms from feeding pumps will be relayed to the nurse call system for all intervention periods. Alternatively meals will be timewise reorganized to not interfer with the intervention resting periods. Signs reminding staff not to disturb will be posted for all intervention periods.
~For each patient the close team of rehabilitation professionals will agree upon a guideline suggesting the optimal resting environment for the specific patient. The guideline wil be based on knowledge gathered from relatives on pre-injury preferences. Furthermore, the guideline will be developed based on a toolbox of possible intervention representing best practice. The toolbox has been designed according to the categories of the International Classification of Functioning.
~The intervention will designed individually for each patient."
15793973|NCT04500951|Other|Standard resting environment|The control condition, standard resting environment, will consist of a basic positioning either reclined in bed or reclined in wheelchair according to regular procedures of the ward. Pressure ulcers and positioning believed to induce pain will be avoided.
15793974|NCT04500925|Procedure|UNILATERAL THYROIDECTOMY|
15793975|NCT04500912|Device|Supraflex Cruz 60 Micron|percutaneous coronary intervention
15793976|NCT04500912|Device|Ultimaster Tansei 80 Micron|percutaneous coronary intervention
15793977|NCT04500899|Drug|Mydfrin|A test dose of 20 mcg of Mydfrin will be administered through the peripheral intravenous line. Subsequent Mydfrin injections will then be administered in 40 mcg aliquots every 10-15 minutes, until the mean arterial blood pressure (MAP) increases by ≥ 20 mm Hg from the baseline MAP, however making sure not to exceed a MAP of 100 mmHg. Once a desired blood pressure has been achieved and maintained, echocardiographic evaluation of mitral regurgitation would be performed.
15793978|NCT04500886|Drug|PEG-rhG-CSF|PEG-rhG-CSF is a sustained-duration form of rhG-CSF, a recombinant methionyl form of human granulocyte colony-stimulating factor (G-CSF), similar to rhG-CSF, PEG-rhG-CSF increases the proliferation and differentiation of neutrophils from committed progenitor cells, induces maturation, and enhances the survival and function of mature neutrophils, resulting in dose-dependent increases in neutrophils.
15793979|NCT04500886|Drug|rhG-CSF|rhG-CSF can increase the proliferation and differentiation of neutrophils from committed progenitor cells, induces maturation, and enhances the survival and function of mature neutrophils.
15793980|NCT04500860|Drug|Low dose tadalafil 5 mg|Efficacy of daily low dose tadalafil 5mg for treatment of female overactive bladder syndrome or urgency with or without urgency urinary incontinence
15793981|NCT04500847|Drug|Emtriva Capsule|200mg daily oral dose
15793982|NCT04500847|Drug|Placebo|200mg daily oral dose
15793983|NCT04500834|Biological|Metal Panel T.R.U.E. Test|Diagnostic patch test
15793984|NCT04500821|Device|Activator LFD-2100|LipiFlow treatment with the Activators LFD-2100 will be performed on both eyes with MGD
15793985|NCT04500808|Drug|Macitentan Dose 1|Participants will receive Dose 1 of macitentan tablet in Part 1.
15793986|NCT04500808|Drug|Macitentan Dose 2|Participants will receive Dose 2 of macitentan tablet in Part 1.
15793987|NCT04500808|Drug|Macitentan Dose 3|Participants will receive Dose 2 of macitentan tablet in Part 1 and 2.
15793988|NCT04500808|Drug|Placebo|Participants will receive matching placebo from Day 1 up to Day 13.
15793989|NCT04500795|Procedure|Middle meningeal artery embolization|"MMA embolization will be performed with a liquid embolization agent with local anaesthesia. Selective angiography will be performed before embolization to select MMA branch targets and detect potentially dangerous collateral vessels. If no dangerous collaterals are found, MMA branches supplying to the dura of convexity will be targeted and embolized according to findings of the selective angiography using a liquid embolization agent. If dangerous collaterals are identified, the microcatheter will be advanced more distally or the collaterals will be coiled prior to embolization. Procedure will be concluded once the flow stasis of MMA is confirmed. Embolization is considered successful if all MMA targets are embolized without procedural complications.
~Patients with existing use of antiplatelet or anticoagulation medication will not undergo medication reversal for the embolization procedure."
15793990|NCT04500782|Other|Observation at home.|An appointment will be made at home, first one of the parents will be interviewed using the 'Social Functioning' subdomain of the PEDI-NL (Ostensjo, Bjorbaekmo, Brogren Carlberg, & Vollestad, 2006) to determine the validity of the CFCS-NL and the VSS NL . This section contains some aspects that question the communication skills. The PEDI-NL was chosen as there is no gold standard to investigate functional communication in people with CP. Most standardized test and observational instruments only investigate language comprehension and / or language production and are furthermore developed for normally developing children. On the other hand, a video recording will be made in which the child interacts with a relative and an unknown person (the researcher) so that the CFCS-NL and VSS-score can be determined by the student and the speech therapists of the CP reference center.
15793991|NCT04500769|Behavioral|Acute Resistance Exercise|Participants will perform three sets of eight repetitions, with a 90-120 second rest between sets, with a fourth set performed to failure. All resistance exercise will be performed on pneumatic resistance devices (Keiser Sports Health Equipment, Fresno, CA).
15793992|NCT04500756|Drug|Metformin|Smaller studies have suggested that metformin may reduce the rate at which aortic aneurysms enlarge. This study will test this question: does metformin prevent AAAs from growing larger?
15793993|NCT04500756|Other|Placebo|One group will be randomized to receive the study drug Metformin and the other group will receive a placebo
15793994|NCT04500743|Drug|Dienogest|Group B (n=67) who had daily oral Dienogest 2 mg/d for 3 months before starting standard long protocol for IVF
15793995|NCT04500743|Drug|leuprorelin acetate|Group A (n=67) who had monthly depot GnRHa for 3 months before ovarian stimulation in IVF treatment (Ultra-long protocol)
15793996|NCT04500730|Drug|Shaoyao Gancao Decoction Jiawei|"Study herb will be prescribed for 28 consecutive days. Study follow up will be offered every 7 days till 56th day after enrolment.
~Daily leg cramps log will be filled in by each individual everyday from day 0 to day 56."
15793997|NCT04500717|Drug|Almonertinib|Almonertinib 110mg PO once daily. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
15793998|NCT04500717|Drug|Almonertinib plus carboplatin and pemetrexed|Almonertinib 110mg PO once daily in combination with pemetrexed (500 mg/m2) plus carboplatin (AUC=5) on Day 1 of 21day cycles (every 3 weeks) for 4-6 cycles, followed by Almonertinib daily with pemetrexed maintenance (500 mg/m2) every 3 weeks.
15794005|NCT04500626|Drug|Oxygen|Hyperbaric oxygen therapy delivered in a monoplace or multi-place chamber. Supervised by a hyperbaric oxygen therapy physician and a chamber operator.
15794006|NCT04500613|Procedure|Bilateral Erector Spinae Plane Block with bupivacaine and dexamethasone|Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures. Dexamethasone is a corticosteroid that reduces inflammation.
15794007|NCT04500613|Other|No bilateral Erector Spinae Plane Block (no bupivacaine and no dexamethasone)|Patients who are randomized to this group will not receive a bilateral erector spinae plane block
15794008|NCT04500600|Other|Quality-of-Life Assessment|Ancillary studies
15794009|NCT04500600|Other|Questionnaire Administration|Complete questionnaire
15794010|NCT04500587|Drug|ZN-d5|Oral agent; 25 mg or 100 mg formulation
15794011|NCT04500574|Drug|Latanoprost eluting contact lens|The latanoprost-contact lens will be worn in one eye for one week.
15794012|NCT04500574|Drug|Topical Latanoprost|A commercial contact lens with no drug will be worn in one eye for one week.
15794013|NCT04500561|Drug|YY-20394|Yy-20394 combined with Gemcitabine and Oxaliplatin was used as a cycle for 21 days. The dose of YY-20394 was 80mg/ day as recommended in phase 2, and the dose of Gemcitabine and Oxaliplatin was treated according to clinical standards.
15794017|NCT04500522|Drug|INH|3 vaginal tablet of isonicotinic acid hydrazide 900 mg inserted by the patient 12 hours before the scheduled office hysteroscopy.
15794018|NCT04500522|Drug|Placebo|3 vaginal tablet of Placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.
15794019|NCT04500509|Drug|diclofenac potassium + dinoprostone|patients will have of oral diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal dinoprostone (6 mg) 6 hours prior to the procedure by the patient
15794020|NCT04500509|Drug|diclofenac potassium + placebo|patients will have of oral diclofenac potassium 60 minutes before the procedure plus one tablets of vaginal placebo 6 hours prior to the procedure by the patient
15794021|NCT04500496|Drug|INH|3 tablet of INH inserted by the patient 12 hours before the scheduled office hysteroscopy
15794022|NCT04500496|Drug|dinoprostone|1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.
15794023|NCT04500483|Diagnostic Test|indirect calorimetry|measurement of resting energy expenditure using indirect calorimetry
15794024|NCT04500470|Drug|Ketoprofen + INH|patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table 900 mg vaginal isonicotinic acid hydrazide by the patient 12 hours before the procedure
15794025|NCT04500470|Drug|Ketoprofen + placebo|patients will have of oral Ketoprofen 60 minutes before the procedure plus 3 table placebo by the patient 12 hours before the procedure
15794026|NCT04500457|Behavioral|Exposure-based Treatment for Perfectionism (ETP)|Three tasks focused on exposures are completed. Each treatment session is approximately twenty minutes.
15794027|NCT04500444|Other|exercise training|An aerobic exercise program with blood flow restriction will be applied 4 times a week for a total of 6 weeks. The aerobic exercise training consists of a warm up period for 5 minutes, walking on treadmill at 4 km per hour speed for 20 minutes and cooling down for another 5 minutes.
15794028|NCT04500431|Biological|Targeting CD269 chimeric antigen receptor engineered T cells|Targeting CD269 chimeric antigen receptor engineered T cells, single infusion intravenously
15794029|NCT04500418|Drug|Cenicriviroc (CVC)|Treatment with Cenicriviroc tablets of 150mg. (450g/300g on day 1 and 300mg/d on days 2-28).
15794030|NCT04500418|Drug|Placebo|Optically identical pills without CVC.
15794031|NCT04500392|Device|High-flow nasal cannula oxygenation|Oxygen is supplied with a high-flow nasal cannula oxygenation device#the flow is up to 60L/min
15794032|NCT04500392|Device|Regular nasal cannula|Oxygen is supplied with a regular nasal cannula #the flow is up to 6L/min
15794033|NCT04500366|Behavioral|Socialization|Social interaction is associated with better mental and physical health, and evidence suggests that group versus individual engagement may offer unique cognitive benefits for older adults as well as peer reinforcement and encouragement.
15794034|NCT04500366|Behavioral|Virtual Group Exercise|Participants will receive twice-weekly (one hour per class) virtual exercise via small-group physiotherapy sessions for a total of 12 weeks. All exercise sessions will occur virtually via a videoconferencing system. The classes will focus on functional movements specifically designed for seniors with frailty and mobility challenges, and will include modifications for gait aids such as canes or walkers. Class sizes will be small to allow for tailoring of exercises based on challenging, safe, progressive, evidence-based exercises. In accordance with recent guidelines to achieve 3 hours/week for fall prevention practice in older adults, participants will also be provided with tailored supplemental home exercises developed by the study physiotherapist to gain an additional 1 hour of physical activity.
15794035|NCT04500366|Combination Product|Nutrition Consult and Protein Supplementation|"Nutrition Consult: Participants will be scheduled for a one-on-one virtual nutrition consult. During the consultation, study staff will assess the nutritional status of the participant and will provide them with counselling and coaching to improve their nutrition.
~Protein Supplementation: Oral nutrition supplements commercially available from Nestle will be provided unless contraindicated. The oral nutrition supplement contains 360 calories and 14 grams of protein per serving. Participants are advised to take this with a meal or within 3 hours of exercise on activity days."
15794036|NCT04500366|Behavioral|Medication Review|A study pharmacist will review the participant's medication list and will utilize Beers and/or START/STOPP criteria to provide recommendations to optimize/update their medications to the participant's healthcare provider. Study geriatricians will be listed as contacts on the primary care provider recommendations and available for consultation.
15794037|NCT04500353|Other|Face mask application for CPAP and/or PPV delivery|Face mask application for CPAP and/or PPV delivery
15794038|NCT04500340|Behavioral|Group CBT for test anxiety|The cognitive-behavioral therapy protocol developed by Flaxman, Bond & Keogh (2004) will be used as the intervention protocol. This protocol consists of 10 Sessions which are provided twice a week (each group will have 10 students).
15794039|NCT04500327|Other|Drive app|The Drive app will be used to monitor sleep metrics for users of CPAP therapy.
15794040|NCT04500327|Device|Non contact motion sensor|The non contact motion sensor will be used as a reference to the Drive app i.e. Drive app overnight recordings will be compared to the non contact motion sensor overnight recordings.
15794041|NCT04500314|Device|whole body vibration device|20 patients will receive vibration training on vibration platform (Power Plate International, Irvine, California, USA) at a frequency of 25-30 Hz and amplitude of 3-5mm, plus traditional physical therapy program 3 sessions per week for total period of 8 weeks. The total duration of the WBV training stimulus will 10 min in first week and progress gradually to 25 min in the 8th week with regular increase by 5 minutes after each 2 successive weeks
15794042|NCT04500314|Other|routine physical therapy treatment|The program consists of 60 minutes supervised and individualized stretching exercise to all involved muscles followed by strengthening for affected muscles, mobilizing exercise for the joints involved to increase the joint range of motion, in addition to scar management techniques including pressure garments, inserts, and physical agent modalities , to avoid scar or contracture formation
15794043|NCT04500301|Other|Preemptive Pharmacogenomic Testing|The use of a pharmacogenomic (PGx) testing to help manage drugs prescribed to subjects for pain and depression.
15794044|NCT04500288|Device|LEFT Device|LEFT device is a novel electronic wearable device that was developed as a sleep position therapy for patients who suffer from nighttime gastroesophageal reflux symptoms. It is simple, noninvasive and low-cost technology which has been developed by Side Sleep Technologies B.V. Singel, Amesterdam, The Netherland.
15794045|NCT04500275|Drug|Vancomycin Hydrochloride|Vancomycin will be spread on sternal edge immediately after sternotomy and before sternal closure
15794046|NCT04500275|Other|Normal Saline|2 ml normal saline will be spread on sternal edge immediately after sternotomy and before sternal closure
15794047|NCT04500262|Device|Open-tip pulsed needle biopsy (NeoNavia Biopsy System)|Ultrasound-guided biopsy using 14G open-tip pulsed biopsy needle
15794048|NCT04500262|Device|Core needle biopsy (CNB)|Ultrasound-guided biopsy using standard of care core needle biopsy
15794049|NCT04500249|Drug|infiltration rescue intraoperative analgesia|in the case of intraoperative pain perception, rescue infiltration analgesia using 1 % lidocaine administered by the operator into the operation field.
15794050|NCT04500249|Drug|rescue IA|in the case of intraoperative pain perception, rescue intravenous analgesia using 50 mcg of fentanyl will be administered by anaesthesiologist
15794051|NCT04500249|Drug|rescue antyhypertensive medication|in the case of intraoperative hypertension reluctant to rescue analgesia, rescue intravenous antihypertensive medication using 10 mcg of urapidil will be administered by anaesthesiologist
15794052|NCT04500249|Drug|rescue antyemetic medication|in the case of postoperative nausea and vomitting, rescue intravenous antiemetic medication using 4 mg of ondansetron will be administered by anaesthesiologist
15794053|NCT04500249|Drug|rescue antyhypotensive medication|in the case of intraoperative hypotension, rescue intravenous antihypotensive medication using 10 mg of ephedrine will be administered by anaesthesiologist
15794054|NCT04500249|Drug|rescue antyhypotensive medication|in the case of intraoperative bradycardia, rescue intravenous antihypotensive medication using 500 mcg of atropine will be administered by anaesthesiologist
15794055|NCT04500236|Other|General anesthesia|Surgery under general anesthesia with the use of propofol
15794056|NCT04500236|Other|Hypno-analgesia|Surgery under Hypnosis session and analgesics
15794057|NCT04500223|Other|Cervical Cranioflexion exercise plus cardiopulmonary exercise|Intervention:Cervical Cranioflexion exercise plus cardiopulmonary exercise
15794058|NCT04500223|Other|Cervical stretch exercise plus cardiopulmonary rehabilitation|control:Cervical stretch exercise plus cardiopulmonary rehabilitation
15794061|NCT04500184|Other|cardiac rehabilitation|rehabilitation performed by professional trainers
15794062|NCT04500171|Behavioral|Colocare Instruction Sheet: SAM + CAM SMOG|Suitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
15794063|NCT04500171|Behavioral|CDC Colorectal cancer screening for life brochure: SAM + CAM SMOG|Suitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
15794064|NCT04500171|Behavioral|Colocare Instruction Sheet: SAM + CAM - Superior rating SMOG - 5th Grade Level|Suitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
15794065|NCT04500171|Behavioral|CDC Colorectal Cancer Screening for Life Brochure: SAM + CAM - Superior rating SMOG - 5th Grade Level|Suitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
15794066|NCT04500171|Behavioral|Colocare Instruction Video: Modified SAM + CAM -Superior rating|Suitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
15794067|NCT04500171|Behavioral|Colocare Instruction Sheet: SAM + CAM Cloze Procedure|Suitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
15794106|NCT04499924|Other|tucatinib placebo|Given twice daily orally
15794107|NCT04499924|Other|trastuzumab placebo|IV on Days 1 and 15 of each cycle
15794068|NCT04500171|Behavioral|CDC Colorectal cancer screening for life brochure: SAM + CAM Cloze Procedure|Suitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
15794069|NCT04500171|Behavioral|Colocare Instruction Sheet: SAM + CAM - Superior rating Cloze Procedure|Suitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
15794070|NCT04500171|Behavioral|CDC Colorectal Cancer Screening for Life Brochure: SAM + CAM - Superior rating Cloze Procedure|Suitability and Comprehensibility Assessment of Materials (SAM + CAM). The SAM + CAM is comprised of 22 evaluation items within the 6 original categories. The SMOG is a readability assessment tool that uses a formula to calculate grade levels by the number of sentences, total number of words in the sentences, and the number of polysyllabic words
15794071|NCT04500158|Drug|Lidocaine|2% Lidocaine with 1:100,000 epi
15794072|NCT04500145|Radiation|SIB-IMRT|60Gy given to the tumor area，50Gy to the CR lesion or high-risk field at the same time
15794073|NCT04500145|Radiation|routine IMRT|patients received IMRT or VMAT，with the prescription of 60Gy/2Gy/30F to the planning tumor volume ，concurrent or sequential with EP chemotherapy
15794074|NCT04500132|Drug|EC-18|EC-18 QD
15794075|NCT04500132|Drug|Placebo EC-18|Placebo EC-18 QD
15794076|NCT04500119|Behavioral|Cedrus RB-844 response pad; Adtech Behnke-Fried micro-electrodes; Neurolynx electrophysiology system; Blackrock Cerestim stimulator|Devices listed are components of a single intervention that includes: Record patient responses (Cedrus RB-844), record neuronal activity (Neurolynx) from electrodes (Adtech Behnke-Fried), apply intermittent electrical stimulation (Blackrock Cerestim)
15794077|NCT04500093|Procedure|Capsulotomy with Repair|Capsulotomy with Repair
15794078|NCT04500093|Procedure|Capsuloectomy|Capsuloectomy
15794079|NCT04500080|Behavioral|PE Intervention|"Each single exercise session will last for one hour and will consist of a combination of the following elements:
~Aerobic Exercise (AE): 20-30 minutes at moderate-high intensity, from 60 to 80% of the maximum heart rate (% HRmax).
~Resistance Exercise (RE): 30 minutes of strength activity of the major muscle groups.
~Neuromotor Exercise (NE): will be integrated with strength exercises and will consist of jumping, balance and coordination activities"
15794080|NCT04500067|Drug|IVIG|Patients in the study group receive the drug Bioven, 10% solution for infusions produced by LLC Biopharma Plasma 0,8-1,0 g/kg once a day for 2 days (total course dose - 1.6-2.0 g/kg) as well as base treatment recommended by the protocol of COVID-19 coronavirus infection treatment depending on the severity of their condition according to the prescription sheet.
15794081|NCT04500054|Other|Music Listening|The music type was chosen by the patients and researchers did not have any influence on their choices.
15794082|NCT04500041|Procedure|Casting|Use of casts applied using corrective maneuvers
15794083|NCT04500041|Device|Bracing|Use of full-time spinal orthosis
15794084|NCT04500028|Drug|INH|3 vaginal tablet of isonicotinic acid hydrazide (900mg) inserted by the study nurse 4 hours before IUD insertion.
15794085|NCT04500028|Drug|Placebo Comparator|3 tablet of placebo inserted by the study nurse 4 hours before IUD insertion.
15794086|NCT04500015|Drug|INH|3 vaginal tablet of isonicotinic acid hydrazide self-inserted by the patient 12 hours before IUD insertion.
15794087|NCT04500015|Drug|Placebo Comparator|3 tablet of placebo self-inserted by the patient 12 hours before IUD insertion.
15794088|NCT04500002|Drug|Isonicotinic Acid Hydrazide|total dose 900 mg per day for 3 days then Misoprosrol 800mcg will be given to all patients for induction of abortion
15794089|NCT04500002|Drug|Misoprostol|Misoprosrol 800mcg will be given to all patients for induction of abortion
15794090|NCT04499989|Drug|INH|3 vaginal tablet of isonicotinic acid hydrazide self inserted 12 hours before IUD insertion.
15794091|NCT04499989|Drug|Placebo Comparator|3 vaginal tablet of Placebo Comparator self inserted 12 hours before IUD insertion
15794092|NCT04499976|Drug|Isonicotinic Acid|Drug: Isonicotinic Acid then misoprostol Drug: Isonicotinic Acid 300mg total dose 900 mg per day for 3 days
15794093|NCT04499976|Drug|Placebo|Drug: placebo then misoprostol Drug: Placebo placebo for 3 days
15794094|NCT04499976|Drug|Misoprostol|Drug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion
15794095|NCT04499963|Drug|Theracurmin HP|The intervention is based on the twice daily dosage of Theracurmin 90 mg capsules used in a trial of patients with mild cognitive impairment
15794096|NCT04499950|Drug|Contrave|Initiate Contrave at 1 tab in morning (AM) for Week 9; then 1 tab in AM and 1 tab in evening (PM) for Week 10; then 2 tab in AM and 1 tab in PM for Week 11; then 2 tab in AM and 2 tab in PM for week 12; then constant dose for months 4-6.
15794097|NCT04499950|Behavioral|Behavioral Weight Loss|6 months of behavioral weight loss. First 3 months are weekly calls with coach and then transition to monthly calls for months 4-6.
15794102|NCT04499924|Drug|tucatinib|300 mg given twice daily orally
15794103|NCT04499924|Drug|trastuzumab|6 mg/kg loading dose will be administered intravenously (IV; into the vein) on Cycle 1 Day 1, followed by 4 mg/kg IV on Cycle 1 Day 15 and then Days 1 and 15 of each cycle thereafter
15794104|NCT04499924|Drug|ramucirumab|8 mg/kg will be administered IV on Days 1 and 15 of each cycle
15794108|NCT04499911|Drug|Isotonic dextrose 5% in water solution|The isotonic dextrose 5% in water solution (a total volume of about 5 ml). Subcutaneous perineural injection of dextrose (5%) in sterile water was given once. The injection was administered by using the Lyftgot technique of neural prolotherapy on the lateral aspect of the thigh along the tender areas.
15794109|NCT04499898|Drug|Carvedilol|Carvedilol
15794110|NCT04499898|Procedure|Endoscopic band ligation|Endoscopic band ligation
15794111|NCT04499885|Device|Paraffin oil gastric lavage|Gastric lavage will be initiated with 50 mL of Paraffin oil and 50 mL of sodium bicarbonate solution
15794112|NCT04499885|Device|Gastric lavage with saline and sodium bicarbonate 8.4%|Gastric lavage with saline and sodium bicarbonate 8.4%
15794113|NCT04499872|Other|Advance Care Plan with Trajectory Touchpoint Technique|Advance Care Plan with Trajectory Touchpoint Technique
15794114|NCT04499859|Drug|Rosuzet 10/5 mg|Initial use of 10mg of ezetimibe combined with 5 mg of rosuvastatin
15794115|NCT04499859|Drug|Rosuvastatin 20mg|20mg of Rosuvastatin as a standard treatment for AMI patients
15794116|NCT04499846|Other|Therapeutic education|Patients will follow a therapeutic education in order to inform them about the mechanism of action of statins. After this intervention a questionnaire will use to measure compliance.
15794117|NCT04499833|Procedure|liver transplant|liver transplant
15794118|NCT04499820|Dietary Supplement|Nutrof|DHA docosahexaenoic acid Omega 3s may be of interest in cases of retinopathies.
15794119|NCT04499820|Dietary Supplement|Meralut|vitamin A, natural flavonoids, lutein and zeaxanthin
15794120|NCT04499807|Other|AFib detection with wearable smart watch|Patients will transmit two rhythm strips every day through both the devices and additional transmission whenever they have symptoms (palpitations, skipped beats, shortness of breath and chest pain). The transmitted rhythm strips are de-identified and analyzed after assigning a unique ID for research purposes.
15794121|NCT04499794|Drug|ALK inhibitor|ALK inhibitor treatment on ALK fusion positive NSCLC patients
15794122|NCT04499781|Behavioral|ACCESS II mHealth Intervention|Participants in the intervention condition will use videoconferencing to connect synchronously with trained HIV+ peer health coaches who will deliver eight weekly, 60-minute cognitive behavioral, motivational sessions for improved ART adherence.
15794123|NCT04499781|Behavioral|ACCESS II control condition|Web-based HIV adherence education. Participants in the control group will connect asynchronously to a web-based HIV ART adherence education condition.
15794124|NCT04499755|Drug|Nucleo CMP Forte|Nucleo CMP Forte twice daily for 6 weeks
15794125|NCT04499742|Radiation|Using Isotope (Tc99m-Sulfur Colloid) to label glucose and administer this directly into duodenum.|Patients will be undergoing Standard of Care procedure EAGBT for collection of duodenal fluid (aspirate and culture) and placement of a catheter into the duodenum. This catheter will be used for infusion of glucose isotope into the small bowel. Subsequently Standard of Care nuclear medicine imaging will be used to track the location of the isotope in the gut.
15794126|NCT04499729|Device|IntelliCare|IntelliCare provides self management and collects symptom self-report data. Symptom severity scores are displayed to the care manager, allowing them to manage the patient's care. The app also provides a secure messaging service for communication between the care manager and the patient.
15794127|NCT04499729|Behavioral|Treatment as Usual (TAU)|Treatment as usual in the Rush Collaborative Care service
15794128|NCT04499716|Procedure|IPACK|25 milliliters of ropivacaine 0.3% will be injected between popliteal artery and femur.
15794129|NCT04499716|Procedure|Femoral triangle block|25 milliliters of ropivacaine 0.3% will be injected on the lateral side of the femoral artery at the distal part of the femoral triangle.
15794130|NCT04499716|Procedure|Obturator nerve block|20 milliliters of ropivacaine 0.3% will be injected between the adductor magnus and adductor brevis muscles and between the adductor brevis muscle the pectineus.
15794131|NCT04499716|Procedure|Femoral nerve block|20 milliliters of ropivacaine 0.3% will be injected in supine position under the fascia iliaca lateral to the femoral artery.
15794132|NCT04499716|Procedure|Sciatic nerve block|25 milliliters of ropivacaine 0.3% will be injected in prone position in the subgluteal space by lateral approach.
15794133|NCT04499716|Procedure|Lateral femoral cutaneous nerve block|5 milliliters of ropivacaine 0.3% will be injected laterally to the sartorius muscle.
15794134|NCT04499703|Device|RHMS-RTM|Assessment of retinal thickness
15794135|NCT04499703|Diagnostic Test|SD-OCT|Assessment of retinal structure
15794136|NCT04499690|Behavioral|Managing Cancer and Living Meaningfully|A brief, individual, manualized psychosocial intervention for patients with advanced and metastatic cancer
15794137|NCT04499677|Drug|Favipiravir|Dosage and method of administration: Day 1: 1800 mg twice daily; Day 2 to Day 7: 400 mg four (4) times daily.
15794138|NCT04499677|Drug|Lopinavir/ Ritonavir|Dosage and method of administration: Day 1: 400mg/100 mg twice daily; Day 2 to Day 7: 200mg/50mg four (4) times daily
15794139|NCT04499677|Other|Favipiravir Placebo|Dosage and method of administration: Day 1: 1800 mg twice daily; Day 2 to Day 7: 400 mg four (4) times daily.
15794140|NCT04499677|Other|Lopinavir/ Ritonavir Placebo|Dosage and method of administration: Day 1: 1800 mg twice daily; Day 2 to Day 7: 400 mg four (4) times daily.
15794141|NCT04499664|Device|Monitoring of the autonomic nervous system|Monitoring of the autonomic nervous system using E-patch, LiDCO and Root-Massimo.
15794142|NCT04499651|Behavioral|Navigation|Trained study navigators will provide one-on-one learning sessions and accompaniments to criminal-justice involved people to help link them to HIV/Hepatitis C care
15794143|NCT04499638|Device|Peripheral vascular catheters|Carry time of common peripheral vascular devices in clinical practice and the reason for his withdrawal
15794144|NCT04499625|Procedure|Sinus floor elevation|
15794145|NCT04499625|Device|Sinus floor elevation using an ultrasonic device|
15794146|NCT04499612|Procedure|Cardiac implantable electronic device implantation.|Patients who have indications will receive cardiac implantable electronic device implantation.
15794147|NCT04499612|Procedure|Cardiac implantable electronic device replace.|Patients who have indications will receive cardiac implantable electronic device replace.
15794148|NCT04499612|Diagnostic Test|Duplex ultrasound.|Patients will undergo ultrasound examination of the vessels of the upper and lower extremities.
15794149|NCT04499612|Diagnostic Test|Echocardiography.|Patients will undergo an ultrasound examination of the heart.
15794150|NCT04499612|Diagnostic Test|Blood sampling.|Patients will be taken venous blood to determine the studied markers of hemostasis system.
15794151|NCT04499599|Other|Dinner|Study subjects will consume a standardized ready-to-eat meal as dinner.
15794152|NCT04499599|Other|Fasting|Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.
15794153|NCT04499599|Other|Study food|Study subjects will either continue to fast for 6 hours (Fast Group), consume either a breakfast (Breakfast Group) or a Fast Bar (Fast Bar Group).
15794154|NCT04499586|Combination Product|Radiotherapy Combined With Raltitrexed and Irinotecan|Each cycle lasts 3 weeks. Raltitrexed: 3mg/m2 per week. Irinotecan : 80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7) per week. Radiation: 45-55Gy/25-30Fx
15794155|NCT04499573|Drug|CD19/CD22 CAR-T|"The treatment plan will be based on stratification by the initial leukemia burden.
~Patients with low disease burden will receive a lymphodepletion chemotherapy of fludarabine (total dose 120mg/m2) and cyclophosphamide (total dose 750mg/m2) over 5 days.
~Patients will high disease burden will receive a lymphodepletion chemotherapy of fludarabine (total dose 120 mg/m2), cyclophosphamide (total dose 750 mg/m2), cytarabine (total dose 900 mg/m2), etoposide (total dose 450 mg/m2), dexamethasone (total dose 30 mg/m2) over 5 days.
~Based on interim analysis the following dosing approach will be implemented starting April 2021:
~Cohort 1: CD19+ disease, low and high burden: 1st dose - 150k/kg, 2nd dose - 850k/kg Cohort 2: CD19- disease, low and high burden: 1st dose - 500k/kg, 2nd dose - 500k/kg Cohort 3: HSCT+CAR-T: 100k/kg"
15794156|NCT04499560|Dietary Supplement|Supplement Drink|Superfoods based nutritional supplement
15794157|NCT04499547|Behavioral|YouTube-delivered aerobic and muscle-strengthening physical activity intervention|Participants in the intervention group will receive two YouTube-delivered videos each week, for 8 weeks. In detail, on Monday, participants will receive an aerobic-based physical activity video with information and a workout to complete and on Thursdays, the participants will receive a video with muscle-strengthening physical activity information and a workout to complete.
15794158|NCT04499534|Biological|Seasonal influenza vaccine|To evaluate immune function in BRCA1/2 mutation carriers without cancer following seasonal influenza vaccination
15794159|NCT04499521|Device|BrachyGel VHPS|Packing system for administering brachytherapy in cervical cancer patients
15794160|NCT04499508|Device|Optima Coil System|Patients who have qualified for endovascular coiling in effort to treat intracranial aneurysms were treated with
15794161|NCT04499495|Other|PENTASA (mesalamine/ 5-Aminosalicylic acid (5-ASA)|"The 5-ASAs of interest in the study are mesalazine (5-ASA); sulfasalazine (5-ASA+sulfapyridine); and balsalazide (5-ASA) and will be grouped together as 5-ASA. For sulfasalazine and balsalazide, the equivalent dose to 5-ASA will be calculated as: balsalazide 6.75g is equivalent to 2.4g of mesalamine; and Sulfasalazine 4g is equivalent to 1.6g of mesalamine.
~The dose will be stratified by oral monotherapy, rectal monotherapy, oral and rectal combination therapy."
15794162|NCT04499482|Other|Food|Soy-fiber containing food
15794163|NCT04499469|Procedure|Spreader Graft|To place and attach with 5.0 PDS suture 2 grafts in the middle third of the nose
15794164|NCT04499456|Other|Personalised Normative Feedback|The Personalised Normative Feedback provides information on 1) alcohol consumption (the number of drinks consumed, alcohol-pattern use, binge drinking); 2) normative comparisons; 3) alcohol-related consequences; 4) practical costs of alcohol consumption (money spent and calories consumed); 5) strategies to avoid or risks associated with alcohol use.
15794165|NCT04499443|Drug|GST-HG131 tablets|This trial includes single-dose studies and multiple-dose studies, The single-dose study included six dose groups of 10 mg, 30 mg, 60 mg, 100 mg, 150 mg, 200 mg, 250mg and 300 mg. Based on the results of a single dose, select 1 to 3 doses to conduct multiple dose studies.
15794166|NCT04499443|Drug|Placebo|This trial includes single-dose studies and multiple-dose studies, The single-dose study included six dose groups of 10 mg, 30 mg, 60 mg, 100 mg, 150 mg, 200 mg, 250mg and 300 mg. Based on the results of a single dose, select 1 to 3 doses to conduct multiple dose studies.
15794167|NCT04499417|Device|Electromyostimulation Whole-Body-Workout|Electromyostimulation - intensity 5 (muscle stimulation)
15794168|NCT04499417|Device|Electromyostimulation Sham Whole-Body-Workout|Electromyostimulation - intensity 0 (no muscle stimulation)
15794169|NCT04499404|Other|Breastfeeding related information delivered by WeChat|Participants in the intervention group will be asked to follow our WeChat public account immoderately after randomization. They will receive breastfeeding related messages three times a week from WeChat, including preparation for breastfeeding after birth and the health benefits of breastfeeding, from baseline until childbirth. After childbirth, intervention group mothers will continue to receive information, which is mainly about breastfeeding, once a week for 6 months. WeChat will send push notifications to remind mothers about the importance of exclusive breastfeeding, build confidence and motivate them to continue exclusive breastfeeding.
15794170|NCT04499404|Other|Non-breastfeeding related information delivered by WeChat|Participants in the control group will be asked to follow our WeChat public account immoderately after randomization. They will receive messages mainly on topics of healthy lifestyle and nutrition during pregnancy, from baseline until childbirth. After childbirth, they will continue to receive information on other topics of interest to mothers, such as immunization, safety, infant growth, and etc., until 6 months postpartum.
15794171|NCT04499391|Other|Project ECHO|Project ECHO utilizes case-based, collaborative learning to support discussion of learners' challenges and barriers to guideline implementation. This differentiates ECHO from traditional learning and facilitates rapid dissemination of medical knowledge and increased capacity to deliver best-practice care.studying innovative approaches.
15794172|NCT04499378|Diagnostic Test|Lung CT|Computed tomography of the thorax
15794173|NCT04499365|Drug|68Ga-DOTA/NOTA-FAPI-04|Each patient receive a single intravenous injection of 68Ga-DOTA/NOTA-FAPI-04, and undergo PET/CT scan within specified time.
15794174|NCT04499365|Diagnostic Test|PET/CT scan|PET/CT scan
15794175|NCT04499352|Drug|BI 754091|BI 754091
15794176|NCT04499352|Drug|BI 836880|BI 836880
15794177|NCT04499339|Drug|SLAMF7 CAR-T|Single infusion of autologous SLAMF7 CAR-T cells
15794178|NCT04499326|Other|Validated quality of life questionnaire (EQ-5D & C-CAP)|Patient quality of life to be assessed at baseline, 1, 2, 3, 4, 6, 9 and 12 months
15794179|NCT04499313|Drug|Dexamethasone|Injectable solution
15794180|NCT04499313|Drug|Methylprednisolone|Injectable solution
15794181|NCT04499300|Other|Data collection from medical files|Data collection from medical files
15794182|NCT04499287|Other|15-minute walk at preferred walking speed.|
15794183|NCT04499287|Dietary Supplement|Fiber|9 grams soluble fiber
15794184|NCT04499287|Other|control|control
15794185|NCT04499274|Drug|0 ul of ondansetron|Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were added with different doses (0 nl) using ondansetron
15794186|NCT04499274|Drug|0.1 ul of ondansetron|Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were added with different doses (0.1 nl) using ondansetron
15794187|NCT04499274|Drug|0.2 ul of ondansetron|Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were added with different doses (0.2 nl) using ondansetron
15794188|NCT04499274|Drug|0.3 ul of ondansetron|Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were added with different doses (0.3 nl) using ondansetron
15794189|NCT04499261|Procedure|laparoscopic surgery|Patients were supine in a reverse Trendelenburg position and received intravenous inhalation combined with anesthesia. The patients' legs were spread apart. A carbon dioxide pneumoperitoneum was established. The intermittent Pringle's maneuver was carried out when necessary. Five trocars were placed in a fan shape around the lesion. Cholecystectomy was performed routinely. First, the liver was mobilized. Then, the liver parenchyma was transected and the branches of the hepatic veins and pedicles encountered were clipped and divided. The lesion was meticulously separated from the vascular structures and liver parenchyma and completely resected. The raw surface was treated with bipolar coagulation to achieve hemostasis and repeatedly washed until no bleeding or bile leakage was confirmed. Finally, the specimens were packed in a specimen bag and removed. The raw surface was packed with biological hemostatic materials, and drainage tubes were routinely placed.
15794190|NCT04499261|Procedure|Open surgery|Patients were placed in the supine position and received intravenous inhalation combined with anesthesia. The intermittent Pringle's maneuver was carried out when necessary. Routinely, a reversed L-shape incision was performed. Cholecystectomy was performed routinely. First, the liver was mobilized. Then, the liver parenchyma was transected and the branches of the hepatic veins and pedicles encountered were clipped and divided. The lesion was meticulously separated from the vascular structures and liver parenchyma and completely resected. The raw surface was treated with bipolar coagulation to achieve hemostasis and repeatedly washed until no bleeding or bile leakage was confirmed. Finally, the specimens were packed in a specimen bag and removed. The raw surface was packed with biological hemostatic materials, and drainage tubes were routinely placed.
15794195|NCT04499235|Drug|Mometasone furoate|Topical mometasone furoate
15794196|NCT04499235|Drug|AKST4290|Oral AKST4290
15794197|NCT04499235|Drug|Placebo|Oral placebo
15794198|NCT04499222|Device|Portex|nasotracheal intubation with PORTEX POLAR [Smiths Medical International, Hythe, United Kingdom] nasotracheal tube.
15794199|NCT04499222|Device|Mallinckrodt|nasotracheal intubation with Mallinckrodt TaperGuard [Covidien, Ireland] nasotracheal tube.
15794200|NCT04499209|Drug|XG005|XG005 Capsule
15794201|NCT04499209|Drug|Combination of Naproxen and Pregabalin|Naproxen and Pregabalin are commercially available products with trade names of Aleve and Lyrica
15794202|NCT04499209|Drug|Placebos|Placebo Capsule
15794203|NCT04499196|Drug|GlucoCorticoid|Administering glucocorticoid
15794204|NCT04499183|Dietary Supplement|fructo- and galacto-oligosaccharides|15 gram/day fructo- and galacto-oligosaccharides
15794205|NCT04499170|Other|Muscular Energy Technique G1|Group of older (G1) - The muscular energy technique (TEM) based on Chaitow's proposal will be applied to the postural posterior muscles of the lower limbs such as gastrocnemius, soleus, ischiostibials, gluteus medius and paravertebral. During TEM, the contraction will be maintained from 7 to 10 seconds, against the resistance imposed by the therapist. After relaxation, range of motion will be gained until your new restriction barrier. This process will be repeated for 3 times.
15794206|NCT04499170|Other|Muscular Energy Technique G2|Group of young people (G2) - The muscular energy technique (TEM) based on Chaitow's proposal will be applied to the postural posterior muscles of the lower limbs such as gastrocnemius, soleus, ischiostibials, gluteus medius and paravertebral. During TEM, the contraction will be maintained from 7 to 10 seconds, against the resistance imposed by the therapist. After relaxation, range of motion will be gained until your new restriction barrier. This process will be repeated for 3 times.
15794207|NCT04499157|Drug|MEMOPTIC|Patients will receive their usual treatment of glaucoma adding 1 tablet of MEMOPTIC per day during 2 years of following
15794208|NCT04499157|Drug|usual treatment of glaucoma|Patients will receive only their usual treatment of glaucoma.
15794209|NCT04499144|Procedure|modified buccal flap and subepithelial connective palatal flap|The connective flap was harvested from the deeper area of the palatal mucosa. Pedicle flap dimensions were reported using the periodontal probe. The flap was then rotated to cover the oro antral communication (OAC) area. The rotation could be in mesial or distal direction, related to OAC position and for the convenience of the donor site. The connective palatal flap was sutured to the buccal periostium using mattress sutures.
15794210|NCT04499131|Drug|Progesterone|Subjects will undergo an artificial cycle with hormone replacement therapy (HRT) with the aim of comparing the endometrial gene expression profile in the different types of exogenous progesterone with different doses and routes of administration.
15794211|NCT04499131|Other|Artificial Cycle (no intervention)|Control group of 15 subjects in the context of a natural cycle with only endogenous progesterone present
15794212|NCT04499118|Drug|AT regimen|Doxorubin 60mg/㎡ d1 or Epirubicin 75mg/㎡ d1 Docetaxel 75mg/㎡ d1 1/21d
15794778|NCT04494399|Drug|Ribavirin|5-day course of oral ribavirin 400mg twice daily
15794213|NCT04499118|Drug|TP regimen|Albumin paclitaxel 125mg/㎡ d1, 8 Cisplatin 75mg/㎡ d1-3 1/21d✖6 or carboplatin AUC6 d1 1/21d✖6
15794214|NCT04499105|Drug|Mesenchymal Stem Cell + NaCl 0,9% 2ml|Patients enrolled in Cipto Mangunkusumo Hospital with degenerative disc disease with no promising result after conventional treatment.
15794215|NCT04499092|Behavioral|Neuropsychological treatment|Neuropsychological treatment
15794216|NCT04499079|Other|Learning Health System|This is a system-level intervention designed to improve collaboration among personnel from the juvenile and behavioral healthcare systems.
15794217|NCT04499053|Drug|Durvalumab|durvalumab in combination with platinum-based doublet chemotherapy. Only subjects who achieve stable disease or better radiological response after 4 cycles of induction treatment will be eligible to continue study treatment in maintenance.
15794218|NCT04499040|Biological|Blood sample|Blood samples to assess biological parameters such as:
15794219|NCT04499040|Other|Fecal samples|Microbiota analysis
15794220|NCT04499040|Behavioral|Neuropsychological|Neuropsychological assessment
15794221|NCT04499027|Diagnostic Test|Lung ultrasound scan|"12 hours postoperatively using a convex ultrasound probe LUS will be performed by an experienced radiologist according to standardized protocols. For each hemi-thorax 3 main areas (anterior (Ant), lateral (Lt) and posterior (Post)) marked by the para-sternal, anterior axillary and posterior axillary lines will be identified. Each one will be divided into upper and lower halves, making a sum of 6 different quadrants for each side: anterior superior, anterior inferior, lateral superior, lateral inferior, posterior superior, posterior inferior.
~For each quadrant a score will be assigned based on B lines which are defined as comet like artifacts indicating subpleural interstitial edema as follows:
~(0) normal aeration: A lines with lung sliding or fewer than two isolated B lines; (1) moderate loss of lung aeration: well-defined, multiple B lines ; (2) severe loss of lung aeration: multiple coalescent B lines; and (3) complete loss of lung aeration or lung consolidation."
15794222|NCT04499014|Device|ultrasound|5 days a week, a total of 10 sessions
15794223|NCT04499001|Other|Pharmacist's consultation|Information about bDMARDs management.
15794224|NCT04498988|Other|Observational study without interventions|
15794225|NCT04498975|Other|Rurality; Ethnicity; Exercise; Hopelessness|Observational study exploring rurality, ethnicity, exercise and hopelessness patterns cross-sectionally and longitudinally
15794226|NCT04498962|Drug|Danzhu Fuyuan Granule|Danzhu Fuyuan Granules，2 times / day, 1 bag / time, one time in the morning and one time in the evening. It is recommended to add the same amount of boiling water as the particles to soak for 30 seconds, and then add 5 times boiling water to dissolve until completely dissolved.The treatment cycle of each arm: 8 weeks for Chronic Stable Angina, 6 months for Vascular Dementia and 6 months for Idiopathic Membranous Nephropathy.
15794227|NCT04498949|Behavioral|UP|"The unified protocol modules are as follows:
~Module 1: Setting the treatment goals and motivation augmentation Module 2: Using psychoeducation to learn the function of emotions and their development Module 3: Mindful (present-focused and non-judgmental) emotional awareness- Core module Module 4: Cognitive flexibility- Core module Module 5: Identifying and countering emotional avoidance behaviors- core module Module 6: Increasing awareness and confronting physical sensations/ interoceptive sensitivity- core module Module 7: Both situational and interoceptive emotion-focused exposures- Core module Module 8: Recognizing accomplishments and looking to the future (relapse prevention)"
15794228|NCT04498949|Other|Treatment as usual|Diagnostic test. Psychoeducation Supoortive care
15794229|NCT04498936|Drug|Sofosbuvir and Ledipasvir|Evaluate the efficacy of Sofosbuvir/Ledipasvir in treatment of COVID-19
15794230|NCT04498936|Drug|Nitazoxanide|Evaluate the efficacy of Nitazoxanide in treatment of COVID-19
15794231|NCT04498923|Drug|Bupivacaine, dexamethasone, epinephrine|Bupivacaine 75 mg, dexamethasone 4 mg, epinephrine 0,18 mg
15794234|NCT04498897|Drug|Vortioxetine|"Baseline: Vortioxetine 10mg (or placebo) + Acamprosate
~First 2 weeks: Vortioxetine 5-10mg (or placebo) + Acamprosate
~Last 6 weeks: Vortioxetine 5-20mg (or placebo) + Acamprosate"
15794235|NCT04498897|Drug|Acamprosate|"Baseline: Vortioxetine 10mg (or placebo) + Acamprosate
~First 2 weeks: Vortioxetine 5-10mg (or placebo) + Acamprosate
~Last 6 weeks: Vortioxetine 5-20mg (or placebo) + Acamprosate"
15794236|NCT04498884|Drug|Rinsulin® mix 30/70|one subcutaneous injection at a dose of 0.4 IU/kg
15794237|NCT04498884|Drug|Humulin® M3|one subcutaneous injection at a dose of 0.4 IU/kg
15794238|NCT04498871|Drug|Nilotinib|Nilotinib is recommended to be administered orally on a continuous schedule at a dose of 400 mg twice daily. The patient should be instructed to take each morning dose of nilotinib 2 hours after a light breakfast (e.g., toast and jam), with no oral intake other than water for 1 hour after dosing. It is recommended that the patient take nilotinib doses every 12 hours with a glass of water. The evening dose of nilotinib should be taken at least 2 hours after dinner with no oral intake other than water for 1 hour after dosing.
15794239|NCT04498858|Other|Patient interview|"Patient will be interviewed :
~tobacco consumption
~reported question asked by the dentist about his/her tobacco consumption
~presence and nature of reported advices given by the dentist
~presence and nature of actions proposed by dentists for patients reporting tobacco consumption, including prescription of NRT
~presence and nature of the actions carried out or envisaged by these patients, including - smoking cessation
~contact with the general practioner
~Fagerstrom score (2 questions)
~demographic variables, age, sex, level of education
~satisfaction"
15794240|NCT04498845|Other|In-home assessment plan|The in-home family educational session provides participants with resources to identify and reduce exposures to metals in the home environment.
15794241|NCT04498845|Behavioral|Family educational session|The 1-hr in-home family educational session, administered during the first home visit to all participants, adapts a motivational interview model to reduce exposure to metals. this done by empowering families to make informed decisions regarding lead and metal exposures in their home environments that originate from different sources with an emphasis on sources from the workplace. The session will consist of both developing a plan tailored for the home and reviewing educational materials on strategies to reduce exposures in the home, focusing on barriers families experience when attempting to change their behaviors.
15794351|NCT04498104|Other|Psychological assessment|Psychological assessment with the repertory grid technique (RGT) in order to quantify cognitive conflicts.
15794352|NCT04498091|Biological|Biological data|Biological data
15794242|NCT04498845|Behavioral|Worker take home prevention training|The take home prevention 1-hour educational session guides the worker through 6 simple steps to identify and then prioritize change/s that can be made before leaving work to prevent take-home lead. It has been adapted from the AGILE model for prioritizing tasks. Participants will also be provided with a pamphlet about how to prevent lead from being taken home.
15794243|NCT04498845|Other|D-LEAD cleaner products|D-LEAD cleaner products include hand wipes, all surfaces cleaner and laundry detergent.
15794244|NCT04498832|Biological|High-Dose Quadrivalent Influenza Vaccine, (Zonal Purified, Split Virus) 2020-2021 Strains (QIV-HD)|Pharmaceutical form:Suspension for injection in pre-filled syringe Route of administration: Intramuscular
15794245|NCT04498832|Biological|Local Standard-Dose Inactivated Quadrivalent Influenza Vaccine, 2020-2021 Strains (QIV-SD)|Pharmaceutical form:Suspension for injection in pre-filled syringe Route of administration: Subcutaneous
15794246|NCT04498819|Behavioral|Wearable Activity Trackers, Exercise Prescription and Virtual Care|"The intervention is merging wearable activity trackers and tailored aerobic exercise prescriptions into the PCDSP's virtual STAND (a biweekly, evidence based, lifestyle medicine) program.
~Participants will wear activity trackers for a week to collect baseline step data (used to create tailored step prescriptions). Biweekly, new step prescriptions will be tailored to each participant based on the previous two week's step count data. The intervention will add onto STAND classes by using activity tracker data into the class discussion for learning opportunities, as well as goal setting and action planning. The day of class, participants will receive a summary email new prescription and encouragement to continue to work hard, using the previous weeks' data to reinforce motivation. The activity tracker will provide instant feedback about step goals, sedentary behaviour and exercise minutes. Individual calls every other week will ensure adherence to exercise regime."
15794247|NCT04498806|Other|Fitbit|The Fitbit device monitors daily activity as a measure of physical function.
15794248|NCT04498793|Biological|Tislelizumab|On Day 1 of the last seven cycles in the neoadjuvant and each cycle in the adjuvant phases of the study for a total of 21 cycles; intravenous (IV) infusion.
15794249|NCT04498793|Drug|Nab paclitaxel|On Days 1 and 8 of Cycles 1-4 in the neoadjuvant phase of the study; IV infusion.
15794250|NCT04498793|Drug|Doxorubicin|On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV injection.
15794251|NCT04498793|Drug|Epirubicin|On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV injection.
15794252|NCT04498793|Device|Cyclophosphamide|On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV infusion.
15794253|NCT04498780|Drug|Sacubitril-Valsartan|Observational study during the clinically indicated treatment
15794254|NCT04498767|Radiation|Stereotactic body radiotherapy|Each lesion may be treated with 1, 3, or 5 SBRT fractions of 16-24 Gy, 24-33 Gy or 25-40 Gy, respectively, depending on the local practice and size & location of oligometastases. Three-fraction regimens will deliver a fraction every second day, and five-fraction regimens are delivered daily. All treatments must be completed within 2 weeks (10 working days) in order to avoid delays in starting systemic therapy.
15794255|NCT04498767|Radiation|Palliative RT|Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications. Recommended dose fractionations in this arm will include 8 Gy in 1 fractions, 20 Gy in 5 fractions, and 30 Gy in 10 fractions. Patients in this arm should not receive stereotactic doses or radiotherapy boosts, unless there is a clearly known clinical benefit (e.g. stereotactic radiation to a new brain metastases when all disease is controlled on systemic therapy).
15794258|NCT04498741|Drug|EDP-938|Subjects will receive EDP-938 once daily on Days 10 through 27 (Part 1)
15794259|NCT04498741|Drug|EDP-938|Subjects will receive EDP-938 once daily on Days 5 through 15 (Part 2)
15794260|NCT04498741|Drug|EDP-938|Subjects will receive EDP-938 once daily on Days 5 through 15 (Part 3)
15794261|NCT04498741|Drug|Tacrolimus|Subjects will receive tacrolimus once daily on Day 1 and Day 24
15794262|NCT04498741|Drug|Dabigatran|Subjects will receive dabigatran once daily on Day 1 and Day 13
15794263|NCT04498741|Drug|Rosuvastatin|Subjects will receive rosuvastatin once daily on Day 1 and Day 13
15794264|NCT04498741|Drug|EDP-938|Subjects will receive EDP-938 once daily on Days 3 through 16 (Part 4)
15794265|NCT04498741|Drug|Midazolam|Subjects will receive midazolam once daily on Day 1 and Day 16
15794266|NCT04498728|Other|Mobile Health Application for Remote Monitoring|The use of the CATCH application (CATCH App), and any data and images obtained from the use of the CATCH App, will all be performed as standard of care for patients at Children's Mercy Kansas City, and will be for the clinical treatment of patients. Data will be collected for the repository for all patients submitting data through the use of the CATCH App. Clinical care team will follow the patients after discharge home from the hospital.
15794267|NCT04498715|Procedure|OSTEOSYNTHESIS|Routine procedure for anesthesia and infection prophylaxis according to the clinics routines will be followed. The patient is supine with the fractured leg positioned in traction table. The biplanar x-ray device is moved and adjusted for proper simultaneous AP and lateral view. Hip region is washed and dressed in sterile draping's. Using standard proximal femur osteosynthesis technique 2.0 mm diameter Kirschner wire is placed in the middle zone of the femoral neck in AP and lateral view. The canal is opened using 6 mm drill bit and measured length of dynamic hip screw is placed in the femoral head and neck.
15794268|NCT04498715|Drug|Zoledronic Acid|Zoledronic acid (ZA), is a bisphosphonate, and has been shown to reduce the risk of hip fracture by 41% in post-menopausal women. For systemic injection, 4 mg (as per clinical protocol) will be injected intravenously 1-2 weeks after surgery. For local delivery, 1 or 2 mg Zoledronic Acid will be added to 5 or 10 mg CERAMENT BVF during mixing and the mixture will be injected.
15794269|NCT04498715|Device|CERAMENT BONE VOID FILLER (BVF)|"CERAMENT™|BONE VOID FILLER is a synthetic, injectable, osteoconductive bone void filler. CERAMENT™I is biphasic, consisting of 60% calcium sulfate and 40% hydroxyapatite mixed with the radio-opacity enhancing component CERAMENT™|C-TRU (iohexol 300 mg iodine/ml), which allows bone in-growth after curing. The high injectability of CERAMENT™ allows transcortical administration and ensures good intraosseous spread. In this trial, CERAMENT BVF paste will be injected by a sterilized metal needle (2-3 mm diameter and 15 cm length) through the hollow dynamic hip screw."
15794270|NCT04498702|Drug|APL-1202 treatment|A modified 3+3 design was employed: The dose was started at 300 mg and increased to 450 mg, 600 mg and 750 mg if there was no dose-limiting toxicity (DLT) in 3 subjects after 4-week consecutive administration of APL-1202. When the dose-escalation study was in progress, the doses for any newly enrolled subjects would be the starting dose or the highest dose confirmed with no DLT by the dose-escalation cohort at the time of enrollment. When the MTD or the 750 mg daily dose was attained as a safe dose, the dose for all subjects in the study or subsequently enrolled subjects would be MTD or 750 mg/day.
15794271|NCT04498689|Drug|Camrelizumab|Patients firstly receive camrelizumab 200 mg per time (iv, no less than 20 minutes and no more than 60 minutes, rinse time included) on Day 1 and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks until the disease recurrence, unacceptable toxicity, death or begin a novel therapeutic.
15794272|NCT04498689|Drug|Nab paclitaxel|Patients secondly receive nab-paclitaxel 100 mg/m2 (iv, at least 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks until the disease recurrence, unacceptable toxicity, death or begin a novel therapeutic.
15794273|NCT04498689|Drug|Gemcitabine Injection|At last, patients receive gemcitabine 1000 mg/m2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks until the disease recurrence, unacceptable toxicity, death or begin a novel therapeutic.
15794274|NCT04498676|Other|CB-0002B|CB-0002B (choline geranate) is a viscous transparent colorless to light yellow liquid
15794275|NCT04498663|Behavioral|Emotion- and Relationship-Focused Therapeutic Interview|In this study, the therapeutic interview will be one-session lasting 90 minutes. Participants will explore prior and ongoing stressful life experiences. Participants will be educated about the role of stress in pain and will be encouraged to identify links between stressors, psychological and emotional conflicts related to the stressors, and their pain symptoms. The interview will encourage the experience and expression of previously avoided emotions related to interpersonal stressors.
15794276|NCT04498650|Drug|PQ912|PQ912 50 mg tablets and 150 mg tablets
15794277|NCT04498650|Drug|Placebo|Placebo tablets to mimic PQ912 50 mg and 150 mg tablets
15794278|NCT04498637|Other|'Attitudes towards people with disability Scale'|The scale 'Attitudes towards people with disability' was completed by the participants. This scale allows the analysis of the attitudes towards disability trough a score whose lower values indicate a more negative attitude and higher values indicate more positive attitudes.
15794279|NCT04498624|Procedure|inverted flap|full thickness macular hole surgery
15794280|NCT04498624|Procedure|peeling internal limiting membrane (ILM)|full thickness macular hole surgery
15794281|NCT04498611|Diagnostic Test|contrast-enhanced breast MRI|Contrast-enhanced MRI will be performed on patients diagnosed with ductal carcinoma in-situ (DCIS) by preoperative biopsy.
15794282|NCT04498598|Device|A/Z Supraglottic airway|Patient receive supraglottic airway for general anesthesia which can be converted to endotracheal ventilation reversibly
15794283|NCT04498585|Other|VR Stimulation|Participants in the intervention group will be provided with 30 minutes of relaxing, 360-degree virtual reality stimulation and corresponding sounds, three times a day (morning, midday, evening) everyday during their stay in the ICU, up to a maximum of 14 days.
15794284|NCT04498572|Other|dry needling|dry needling for Gluteus Medius muscle in combination with exercises
15794285|NCT04498572|Other|sham dry needling|sham dry needling for Gluteus Medius muscle in combination with exercises
15794286|NCT04498533|Other|forearm strap (counterforce brace)|
15794287|NCT04498533|Other|Kinesio tape application|
15794288|NCT04498520|Drug|Abexinostat Tosylate|Given PO
15794289|NCT04498520|Drug|Fulvestrant|Given IM
15794290|NCT04498520|Drug|Palbociclib|Given PO
15794291|NCT04498507|Diagnostic Test|HADS questionnaire|Patients will be asked to answer to 3 questionnaires about anxiety and depression, post-traumatic stress disorder and health-related quality of life
15794292|NCT04498494|Device|ECG|12-lead ECG
15794293|NCT04498468|Drug|Sustained Release Dexamethasone, 0.4 mg|dexamethasone 0.4mg lacrimal insert
15794294|NCT04498468|Other|E-Caprolactone-L-Lactide copolymer (PCL) punctal plug|Control eye will receive a tear duct plug without the dexamethasone (EXTENDED WEAR SYNTHETIC ABSORBABLE PUNCTAL PLUG made of E-Caprolactone-L-Lactide copolymer (PCL). Absorbs in 60 to 180 days. Size 0.5mm which is comparable to the study treatment)
15794295|NCT04498455|Dietary Supplement|Prebiotin|Fructo-oligosaccharide dietary supplement powder
15794296|NCT04498442|Behavioral|Simha Kriya|Simha-Kriya involves deep breathing exercises and meditation. It is the practice of extending the breath, expanding our lung capacity and mental concentration and energizing the body. Simha Kriya, when practiced intentionally will unite the mental, physical, and spiritual body through the breath. For the purpose of this study we advocate practice of Simha Kriya at least once a day.
15794297|NCT04498442|Behavioral|Reading a Book|Reading a book regularly promotes knowledge enhancement, reduces stress and enhances memory among other benefits. Reading a book is often inculcated into mindfulness research due to it's impact on the personality and attitude. The simple act of reading a book can have a significant impact on their attitudes and can help them cope better with stress. For the purpose of this study, we advocate reading any book/ journal of participants choice routinely for 15 minutes each day. Reading a book could potentially be substituted with sitting idle for 15 minutes if participants wishes to.
15794298|NCT04498429|Other|Integrated Cueing Protocol|The first 5 repetitions will include part to whole task practice of partial sit to stand using scripted verbal cueing to facilitate understanding of the task. The goal is to improve midline orientation and alignment during the task of moving from sitting to standing. In addition to verbal cueing, the manual cueing group will receive hands-on tactile facilitation from a trained physical therapist to facilitate appropriate midline weight shift during the sit to stand activity for the series of 40 training repetitions.
15794299|NCT04498429|Other|Verbal Cueing Protocol|The first 5 repetitions will include part to whole task practice of partial sit to stand using scripted verbal cueing to facilitate understanding of the task. The goal is to improve midline orientation and alignment during the task of moving from sitting to standing. The verbal cueing protocol consists of verbal cueing from a trained physical therapist to facilitate appropriate midline weight shift during the sit to stand activity for the series of 40 training repetitions.
15794353|NCT04498091|Other|Clinical data|Clinical data
15794300|NCT04498416|Diagnostic Test|Quantitative and qualitative assessments of mental health|Emergency semi-directed interview; Diagnosis Infant and Preschool Assessment (DIPA); Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS); Conners Scale - short version;Weiss functional impairment rating scale - parent (WFIRS); Parenting stress index-short form (PSI-SF); Anxiety Scale
15794301|NCT04498403|Drug|Crisaborole 2%|Crisaborole 2% ointment
15794302|NCT04498390|Drug|LY3493269|Administered orally.
15794303|NCT04498390|Drug|Placebo|Administered orally.
15794304|NCT04498377|Biological|F-652|IL-22 fusion protein administered intravenously
15794305|NCT04498377|Biological|Placebo|Placebo administered intravenously
15794306|NCT04498364|Behavioral|Habit Reversal Training|Habit Reversal Training (HRT) is a multi-component evidence-based treatment for tics.
15794307|NCT04498351|Drug|Control Test|"Spermatic cord block by18ml levobupivacaine 0.5% plus 2 ml normal saline in total volume of 20 ml.
~The procedure is repeated on the contralateral side."
15794308|NCT04498351|Drug|Dexmedetomidine|Spermatic cord block by total of 18ml levobupivacaine 0.5% plus 1 μg/kg dexmedetomidine in 2 ml in total volume of 20 ml The procedure is repeated on the contralateral side.
15794309|NCT04498351|Drug|Dexmedetomidine and magnesium sulphate|"Spermatic cord block by total of 18ml levobupivacaine 0.5% plus 1 μg/kg dexmedetomidine and 100 mg magnesium sulphate in 2 ml in total volume of 20 ml .
~The procedure is repeated on the contralateral side."
15794310|NCT04498351|Drug|magnesium sulphate|Spermatic cord block by total of 18ml levobupivacaine 0.5% plus 100 mg magnesium sulphate in 2 ml in total volume of 20 ml
15794311|NCT04498338|Other|Neural mobilization combined with conventional physical therapy program|Neural mobilization of sciatic nerve combined with TENs and exercise program applied 3 times/week for successive 6 weeks.
15794312|NCT04498338|Other|Conventional physical therapy program|TENs and exercise program applied 3 times/week for successive 6 weeks.
15794313|NCT04498325|Drug|NT-I7|Supplied by study
15794314|NCT04498325|Drug|Placebo|Supplied by study
15794315|NCT04498325|Procedure|Blood for research purposes|Prior to injection (Day 0), Day 7, and Day 14
15794316|NCT04498325|Procedure|Blood for pharmacokinetic samples|-Phase I only: 1-2 hours prior to dosing, 6 hours after dosing, 24 hours after dosing, Day 7, Day 14, and Day 21
15794317|NCT04498325|Procedure|Nasopharyngeal, oropharyngeal, or saliva swab|-Prior to study treatment, Day 4(optional), Day 7, and Day 14
15794318|NCT04498325|Procedure|Blood for anti-drug antibody (ADA)|Baseline, Day 7, Day 14, Day 21, Day 60, and Day 90. Participants with ADA positivity on Day 90 will be monitored every 90 days until antibody level returns to baseline
15794319|NCT04498312|Other|Extracorporeal shock wave|The participant was placed into supine lying position then the head of the shock wave was applied on the anterior or posterior aspect of the thigh which was scanned with 2000 shots for both horizontal direction and vertical direction. The period of each session was 15 minutes, 2 times/week for 4 weeks
15794320|NCT04498299|Diagnostic Test|echocardiogram 2D|The patient is accelerating against a workload that gradually increases at a constant rate during the exercise, images will be obtained by echocardiography. The patient begins with 25 Watts with increments of 25 Watts every 3 minutes, continuing the exercise until significant electrocardiographic changes occur or the patient starts with symptoms.
15794321|NCT04498286|Diagnostic Test|Testing of SARS-CoV-2 antibodies|Sars-CoV-2 RBD total antibody test developed by Sanquin
15794322|NCT04498273|Drug|Apixaban 2.5 MG|Subjects will be contacted either electronically or by telephone within 24 hours of randomization to confirm receipt of the study treatment. Study drug will be shipped to subjects home. Subjects will take Apixaban 2.5 MG twice a day; once in the morning and once in the evening for 45 days. Subjects will be contacted (electronic or telephone) minimally weekly after initial start of study medication and contact will continue up to day 75 after starting study treatment. Follow up electronic contact will be dependent on initial patient response, compliance with response, and medication adherence, for the trial duration using electronic contacts and through telephone contacts. Participants will be queried for any clinically relevant endpoints, especially major bleeding, or need to seek healthcare attention for any reason. Follow-up will occur from the time of study drug receipt and through the 30 day safety period.
15794323|NCT04498273|Drug|Apixaban 5MG|Subjects will be contacted either electronically or by telephone within 24 hours of randomization to confirm receipt of the study treatment. Study drug will be shipped to subjects home. Subjects will take Apixaban 5 MG twice a day; once in the morning and once in the evening for 45 days. Subjects will be contacted (electronic or telephone) minimally weekly after initial start of study medication and contact will continue up to day 75 after starting study treatment. Follow up electronic contact will be dependent on initial patient response, compliance with response, and medication adherence, for the trial duration using electronic contacts and through telephone contacts. Participants will be queried for any clinically relevant endpoints, especially major bleeding, or need to seek healthcare attention for any reason. Follow-up will occur from the time of study drug receipt and through the 30 day safety period.
15794324|NCT04498273|Drug|Aspirin|Subjects will be contacted either electronically or by telephone within 24 hours of randomization to confirm receipt of the study treatment. Study drug will be shipped to subjects home. Subjects will take Aspirin twice a day; once in the morning and once in the evening for 45 days. Subjects will be contacted (electronic or telephone) minimally weekly after initial start of study medication and contact will continue up to day 75 after starting study treatment. Follow up electronic contact will be dependent on initial patient response, compliance with response, and medication adherence, for the trial duration using electronic contacts and through telephone contacts. Participants will be queried for any clinically relevant endpoints, especially major bleeding, or need to seek healthcare attention for any reason. Follow-up will occur from the time of study drug receipt and through the 30 day safety period.
15794354|NCT04498078|Dietary Supplement|Creatine|Creatine monohydrate (20 g per day)
15794355|NCT04498065|Biological|Biological data|Biological data
15794356|NCT04498065|Other|Clinical data|Clinical data
15794402|NCT04497688|Drug|PEG-rhG-CSF|Patients received a single dose of PEG-rhG-CSF per cycle. The chemotherapy regimen must meet the interval between two chemotherapy sessions at least 12 days.
15794403|NCT04497662|Drug|KPL-404|humanized IgG4 monoclonal antibody
15794404|NCT04497662|Other|Matching Placebo|Placebo
15794405|NCT04497649|Drug|Sofosbuvir|Sofosbuvir once daily
15794325|NCT04498273|Drug|Placebo|Subjects will be contacted either electronically or by telephone within 24 hours of randomization to confirm receipt of the study treatment. Study placebo will be shipped to subjects home. Subjects will take placebo twice a day; once in the morning and once in the evening for 45 days. Subjects will be contacted (electronic or telephone) minimally weekly after initial start of study medication and contact will continue up to day 75 after starting study treatment. Follow up electronic contact will be dependent on initial patient response, compliance with response, and medication adherence, for the trial duration using electronic contacts and through telephone contacts. Participants will be queried for any clinically relevant endpoints, especially major bleeding, or need to seek healthcare attention for any reason. Follow-up will occur from the time of study drug receipt and through the 30 day safety period.
15794326|NCT04498260|Drug|Local steroid - triamcinolone acetonide|(triamcinolone acetonide)
15794327|NCT04498260|Drug|Oral steroid - predonisolone|(predonisolone)
15794328|NCT04498247|Biological|V591|1 or 2 ascending doses of V591 will be administered via intramuscular (IM) injection.
15794329|NCT04498247|Other|Placebo|Placebo (0.9% sodium chloride) administered via IM injection.
15794330|NCT04498234|Procedure|ultrasound guided erector spinae plane block with bupivacaine 0.25% And ultrasound guided Paraveretebral block with bupivacaine 0.25 %|One groupvwill receive 0.25% bupivacaine (20 ml ) into interfascial plane below erector spinae muscle at level of T4 and the other group willreceive (0.3 ml /kg ) 0.25% bubivicaine divided equially at each level of T2 , T4 and T6 at thoracic paravertebral space .
15794331|NCT04498221|Procedure|Imaging procedure|During routine examination under anaesthetic 4 x peritumoural injection of Lymphoseek (lymphatic mapping tracer) followed by freehand SPECT scan
15794332|NCT04498221|Procedure|Surgical procedure|Excision of contralateral nodes identified on imaging *(fhSPECT or SPECT/CT*) during routine examination under anaesthetic. Serial sectioning of excised (sentinel) nodes to identify micrometastasis.
15794333|NCT04498208|Behavioral|Physical Prehabilitation|First, an evaluation of patient's aerobic capacity, functional mobility, functional strength, ambulation, fall risk, and overall mobility will be done by a trained member of the research team. Based on their functional level and preexisting conditions, therapeutic exercises will be recommended to optimize their strength, endurance, flexibility, and functional mobility in preparation for surgery. Decisions about the interventions are based on the assessment, individual patient characteristics, environmental factors, surgical type, and monitoring of the client's response and progress. Weekly sessions are 30-45 minutes long to monitor the client's response and progress their program. Based on their response to exercise (evaluated also by 2 apps: Timed Walk App and Smart Metronome & Tuner App), re-evaluation via the assessments described above, change their plan of care (alter frequency, resistance, exercises) or discontinuation of treatment could be decided.
15794334|NCT04498208|Behavioral|Stress Reduction Prehabilitation|Participants will have the opportunity to learn techniques for mindfulness that have been established to reduce stress and assist with pain management with a member of the research team. Patients will be offered to listen to audio recording of relaxation sessions. Each session contains a relaxation technique that the patient practices while listening to the recording. Then the technique is used the next as a baseline to introduce a new technique more advanced. For some patients who struggle with the techniques the program will be adapted. Patients will choose 2 or 3 techniques and work on them.
15794335|NCT04498208|Behavioral|Cognitive Prehabilitation|Cognitive prehabilitation will consist on the daily use of Lumosity training program, an already existing free app built to increase memory skills. The program proposed by Lumosity is tailored to each patient. The use of Lumosity will be monitored at each in-person session. Patients will be expected to complete at least three 5-minute sessions of Lumosity training per day.
15794336|NCT04498208|Behavioral|Nutrition Prehabilitation|Nutrition prehabilitation will involve transitioning the patient to the Mediterranean diet with targets regarding hydration and the proportion of fruits, vegetables, whole grains, and healthy fats the patient will consume in a given day. This nutritional program is flexible, and it allows for specific physician and nutritionist-recommended dietary needs to be incorporated. The patient is also given tools to encourage success in healthier eating, including recipes, sample menus, healthy restaurant options, meal kit options, and local CSA box options
15794337|NCT04498195|Behavioral|increased exercise and physical activity|Participants were encouraged to increase physical activity for 12-week study duration and wear an activity tracker for a minimum of 12 hours a day.
15794338|NCT04498182|Drug|AR15512|Administered via topical ocular instillation, one drop per eye, twice daily for 84 days. Both eyes will be treated.
15794339|NCT04498182|Drug|Vehicle|Administered via topical ocular instillation, one drop per eye, twice daily for 84 days. Both eyes will be treated.
15794340|NCT04498169|Drug|Netarsudil Ophthalmic|Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution
15794341|NCT04498169|Drug|Netarsudil Ophthalmic|Netarsudil Ophthalmic Solution 0.02% Topical Sterile Ophthalmic Solution
15794342|NCT04498156|Other|No intervention|No intervention, observational study
15794343|NCT04498143|Other|"Project SAVE (Stop Adolescent Violence Everywhere) SSI"|Internet-based, 30-minute single session intervention targeting NSSI via decreasing urge to act on self-punishment/self-harm thoughts/urges.
15794344|NCT04498143|Other|"Active Comparator: Supportive Therapy (Share Your Feelings) SSI"|Internet-based, 30-minute single session intervention to increase feelings disclosure.
15794345|NCT04498130|Behavioral|12-Week Home Exercise Group|12 week home-based program consisting of: weekly Zoom group chats; exercise videos; free exercise equipment and pedometer; an exercise manual with worksheets to promote increased physical activity; access to a unique group social media page
15794346|NCT04498130|Behavioral|Education Comparison Group|12 week home-based program consisting of: weekly check-in phone calls; exercise videos; free exercise equipment and pedometer; an exercise manual with worksheets to promote increased physical activity; access to a unique group social media page.
15794347|NCT04498117|Biological|Oregovomab|2 mg, dissolved in 2 mL of 0.9% Sodium Chloride Injection USP, then added to 50 mL of Sodium Chloride Injection USP infused over 20 ± 5 minutes
15794348|NCT04498117|Drug|Paclitaxel|175 mg/m^2, every 3 weeks
15794349|NCT04498117|Drug|Carboplatin|AUC 6 IV Day 1 x 6 cycles (every 21 days)
15794350|NCT04498117|Biological|Placebo|2 mg, dissolved in 2 mL of 0.9% Sodium Chloride Injection USP, then added to 50 mL of Sodium Chloride Injection USP infused over 20 ± 5 minutes
15794357|NCT04498052|Other|EHR-integrated Shared Decision Making Tool and Clinical Decision Support for Lung Cancer Screening|"The intervention will consist of the following core items:
~An EHR-integrated shared decision making (SDM) tool for providing information on the risks and benefits of lung cancer screening through low-dose computed tomography (LDCT) testing. This intervention is referred to as Decision Precision+.
~Suggestions in the EHR to offer SDM for LDCT for patients eligible for lung cancer screening according to USPSTF guidelines. These suggestions include those provided by the EHR's Health Maintenance module as well as an EHR-integrated Disease Manager system for disease management and health maintenance.
~Improvements may also be introduced based on user feedback. All major enhancements will be introduced with the support and approval of the appropriate governance group.
~Following roll-out, clinic leaders may also receive periodic feedback on use of the intervention and LDCT screening rates, as well as advice on how to improve intervention adoption."
15794358|NCT04498039|Device|Portable Neuromodulation Stimulator|Examining the effect of targeted physical therapy with and without cranial nerve non-invasive neuromodulation (CN-NINM), on the walking ability of people with MS who exhibit a dysfunctional gait. Adopting a rehabilitative strategy using neuromodulation of the cranial nerves via electrical stimulation of the tongue to enhance the plasticity of the brain.
15794359|NCT04498026|Device|Adherus Dural Sealant System|Adherus Dural Sealant, In situ polymerizing sealant
15794360|NCT04498026|Device|DuraSeal Exact Dural Sealant System|DuraSeal Exact (P080013b)
15794361|NCT04498013|Drug|Cyclodynon|Cyclodynon 1 tablet a day during 6 menthes period.
15794362|NCT04498013|Behavioral|Lifestyl modification|Measures to normalize the hygiene of work and rest. A diet aimed at achieving an optimal body mass index. Teaching relaxation techniques to increase resistance to chronic stress.
15794363|NCT04497987|Drug|LY3819253|Administered IV.
15794364|NCT04497987|Drug|Placebo|Administered IV.
15794365|NCT04497987|Drug|LY3832479|Administered IV.
15794366|NCT04497974|Other|Dietary intervention|Varying the exposure to sweetness via diet manipulation.
15794367|NCT04497961|Drug|Lenalidomide|dose of 10mg oral lenalidomide on days 1-21 of each 28-day cycle.
15794368|NCT04497961|Drug|Daratumumab|1800 milligrams (mg) subcutaneous (SC) injection of daratumumab as follows: days 1, 8, 15, and 22 of cycles 1 and 2; days 1 and 15 of cycles 3-6; day 1 of cycles 7-36
15794369|NCT04497961|Behavioral|Questionnaires|EORTC QLQ-C30, EORTC QLQ-MY20, PRO-CTCAE)
15794370|NCT04497948|Drug|Acalabrutinib|Acalabrutinib (CALQUENCE®) is a covalent BTK inhibitor
15794371|NCT04497935|Drug|PLENVU|Bowel preparation for a colonoscopy
15794372|NCT04497935|Drug|MoviPrep|Bowel preparation for a colonoscopy
15794373|NCT04497922|Device|e-ink screen|A virtual display screen developed by e-ink that displays patient status, basic demographics, care team information, pending tests and anticipated disposition
15794374|NCT04497922|Behavioral|Treatment as usual|Treatment as usual in the emergency department with communication of testing results, imaging and disposition by the primary clinical emergency department team.
15794375|NCT04497909|Behavioral|Mindfulness|Mindfulness online training
15794376|NCT04497896|Other|Repair of open globe injury|repair of corneal, corneoscleral, or scleral wounds
15794377|NCT04497883|Drug|Maribavir (400 mg)|Non-Hispanic, Caucasian group and Japanese descent group participants will receive 400 mg maribavir tablets orally once on Day 1 during treatment period 1.
15794378|NCT04497883|Drug|Maribavir (200 mg)|Japanese descent group participants will receive 200 mg maribavir tablets orally once on Day 1 during treatment period 2 or 3.
15794379|NCT04497883|Drug|Maribavir (800 mg)|Japanese descent group participants will receive 800 mg maribavir tablets orally once on Day 1 during treatment period 2 or 3.
15794380|NCT04497870|Drug|Peppermint oil|Administration of peppermint oil at one of two daily doses.
15794381|NCT04497857|Other|Coordinated Specialty Care (CSC)|CSC care is an evidenced-based, comprehensive specialty care programs for young people in the initial phases of psychotic disorders
15794382|NCT04497844|Drug|Niraparib|Participants will receive Niraparib 200 mg once daily.
15794383|NCT04497844|Drug|Abiraterone acetate (AA)|Participants will receive AA 1000 mg once daily.
15794384|NCT04497844|Drug|Prednisone|Participants will receive prednisone 5 mg once daily.
15794385|NCT04497844|Drug|Placebo for Niraparib|Participants will receive matching placebo for Niraparib once daily.
15794386|NCT04497831|Drug|Morphine hydrochloride|5 mg milligram(s) per day per two days of dosage
15794387|NCT04497831|Drug|Placebo|Inhalation use
15794388|NCT04497818|Other|Cross Sectional study using scientifically validated psychometric Scales|Cross Sectional study using scientifically validated psychometric Scales (FEAR OF COVID-19, a 5 item Likert Scale & Modified Dental Anxiety 5 item Likert Scale).
15794389|NCT04497805|Biological|ALLO-ASC-SHEET|Hydrogel sheet containing Allogenic Mesenchymal Stem Cells
15794390|NCT04497792|Drug|Empagliflozin 10Mg Tab|Patients from treatment group received empagliflozin 10 mg daily additionally to previously prescribed diabetes medication
15794391|NCT04497792|Drug|hypoglycemic therapy|hypoglycemic therapy.
15794392|NCT04497779|Procedure|Biospecimen Collection|Undergo collection of blood and/or nasopharyngeal swabs
15794393|NCT04497779|Other|Diagnostic Laboratory Biomarker Analysis|Correlative studies
15794394|NCT04497779|Other|Electronic Health Record Review|Donors and recipients have their medical records reviewed.
15794395|NCT04497779|Other|Questionnaire Administration|Ancillary studies
15794396|NCT04497766|Drug|Nebulized Magnesium sulfate|MgSO4 100mg in 20 ml normal saline will be given via ultrasonic nebulizer over 10 minutes,and PAS score will be assessed at 30,60,120,240,360 minutes
15794397|NCT04497766|Drug|Intravenous magnesium sulphate|pts age 2 to 12 years will receive intravenous magnesium sulphate 50 mg/kg over half hour
15794398|NCT04497727|Other|Gene Expression|Gene expression analysis of biopsy specimens obtained during routine colonoscopy examination
15794399|NCT04497714|Diagnostic Test|Ultrasonic image collection|Ultrasonic image collection,consist of three static images and one dynamic image
15794400|NCT04497701|Drug|PEG-rhG-CSF group|Patients received a single dose of 100 ug/kg of PEG-rhG-CSF（Jinyouli®）, on the basis of actual body weight. Peg-rhG-CSF can be used prophylactically only when the interval between two chemotherapy regimens is no less than 12 days.
15794401|NCT04497701|Drug|rhG-CSF group|Patients received 5μg/kg/d of rhG-CSF, on the basis of actual body weight.
15794407|NCT04497623|Device|Invasive mechanical ventilation using the Unisabana-Herons Ventilator during 24 hours|Recruited patients will receive volume-controlled mechanical ventilation (assist-control mode) using the Unisabana-Herons ventilator for 24 hours. Information on clinical, hemodynamic, and respiratory variables will be recorded from 30 minutes before the start of mechanical ventilation with the Unisabana-Herons ventilator. Recordings will be made in the first 4 hours every 15 minutes in the CFR, except for arterial blood gases which will be taken every 30 minutes. In the following 20 hours, arterial blood gas controls will be taken at hour 12 from the start of the ventilator and at hour 24. Other hemodynamic and respiratory variables will be recorded every hour from hour 4 of ventilator start until hour 24.
15794408|NCT04497610|Diagnostic Test|Breath sample|Patient will blow into a tube 5 times.
15794410|NCT04497571|Procedure|Piezoelectric osteotomy.|Implants placed using the ultrasonic technique.
15794411|NCT04497571|Procedure|Conventional drilling|Implants placed using drilling technique
15794412|NCT04497558|Diagnostic Test|Endometrium biopsy|In the experimental group, those patients undergo endometrial receptivity array. In the control group, those patients do not receive any treatment before next cycle of transfer. In the experimental group, according to the results of endometrial receptivity array, the transplantation time will be adjusted and retransplantation will be carried out. In the control group, no intervention will be performed.
15794413|NCT04497545|Device|Luna EMG|The duration of the overall therapeutic intervention in both groups will be the same.
15794414|NCT04497545|Device|lower limb rotor|The duration of the overall therapeutic intervention in both groups will be the same.
15794415|NCT04497532|Other|Diet as suited for gestational diabetes mellitus|Diet that consists of complex carbohydrates, and a regimen that includes 6 meals per day, as tailored gor gestational diabetes.
15794416|NCT04497519|Drug|inhaled hydroxychloroquine|ascending dose of iHCQ
15794417|NCT04497506|Behavioral|Wise Intervention (Self-affirmation and Incremental theory of personality)|The intervention designed to promote prosocial behavior and reduce online risks is based on four general types of change strategies: (1) scientific knowledge, (2) generation of new meanings, (3) commitment through action, and (4) active reflection. It includes two components: a self-affirmation activity and an ITP intervention. The SA component includes a list of values so that they could choose the two or three most important for them. Next, they are asked to write why those selected values are the most important to them. The ITP component includes activities such as reading scientific information about social behavior and its role in people's well-being, the meaning and value of online risk behaviors through stories and videos of the experiences of other young people of their age, and self-persuasion exercises that involve an active commitment to change.
15794418|NCT04497506|Behavioral|Standard preventive intervention|It consists of an educational intervention that provides a number of strategies to manage everyday conflicts among adolescents. This intervention teaches them new ways to manage these difficulties through different actions (relaxation, distraction, sports, etc.). Finally, they are asked to plan the strategies they will use in the future in the face of some difficulties and to recommend some guidelines for another adolescent who may be going through a similar situation.
15794421|NCT04497480|Behavioral|Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation Training System|The Passive, Motor-Assisted and Active Resistive Upper/Lower Extremities Rehabilitation Training System is designed for patients conﬁned to bed at the long-term care facilities hospitals, in early rehabilitation. This system can induce a natural movements of the upper/lower limb with safe motorized passive movement, as well as motor-assisted and active resistive muscle training to stimulate nerves, increase blood circulation of aﬀected tissue, cell metabolism and improve joint mobility, in promoting upper/lower extremities motor recovery.
15794422|NCT04497454|Other|EIT-Group|A mechanical ventilation strategy with the main goal to maintain DP < 16 cmH2O
15794423|NCT04497454|Other|ARDSNet|Low PEEP-FiO2 table ARDS Network ventilation protocol
15794424|NCT04497441|Other|Electronic Survey questionnaire|"This Cross sectional study utilizes an electronic google form to get responses from netizens of Al Qassim province of Saudi Arabia regarding the perception of COVID-19 information and information sources. All the questions in the survey are compulsory answerable questions. The settings in the google form are set so that a single respondent can limit the survey response to single time. The Survey Questionnaire contained following sections:
~Section I: Minimum required personal details Section II: 10 Questions regarding the source of COVID-19 information Section III: 6 Questions regarding perception of the COVID-19 information
~The very first part of the Questionnaires seeks responders' consent for giving responses to the survey questions. participation Section II & III contained all closed ended questions. The Google form link is shared to the netizens of Al Qassim province across relevant Social media platforms."
15794425|NCT04497428|Behavioral|Adaptation|Sensorimotor adaptation in speech
15794426|NCT04497428|Other|cTBS|continuous theta-burst stimulation
15794427|NCT04497415|Other|Video-Based intervention|Three minutes video of a nurse that shares her personal story
15794428|NCT04497389|Biological|Human Amniotic Fluid|Patients will receive 10ml intravenous hAF each day for 5 consecutive days.
15794488|NCT04496921|Dietary Supplement|Vitamin K supplementation, dose #2|Vitamin K supplement : 7mg, twice a week, for 6 months. Complete biochemical profile, weight and size (body mass index), drugs list, pulmonary function by spirometry (FEV, etc.). Food frequency questionnaire.
15794489|NCT04496908|Procedure|amniotomy|Artificially rupturing membranes
15794429|NCT04497376|Procedure|upgraded '2C3L'|EI-VOM: 2 to 4 mL of 95% ethanol will be slowly injected over 1 minute into the distal VOM, After 5 minutes, another injection will be performed for the middle and then proximal part of the VOM. In total, 6 to 12 mL of ethanol will be used as the maximum dose. '2C3L' ablation procedure: The roof and posterior segments will be ablated first when performing left PVI, and RF will not be applied for the anterior part of the left PV unless necessary. MI ablation will commence at about 1 cm from the junction of the VOM and coronary veins near the annulus side and extend along the isthmus to the low-voltage area. Ablation will also be performed in the distal CS, the corresponding epicardial site. Next, CTI ablation will be performed starting from the tricuspid valve annulus and proceeding to the inferior cava veins. The procedural endpoint will be isolation of the bilateral PVA and complete conduction block across the three ablation lines.
15794430|NCT04497376|Procedure|pulmonary vein antral isolation|The right PV antrum (PVA) will be ablated first, followed by the left PVA. RF should be applied 1 cm proximal to the PV ostia in a wide-area circumferential pattern. Complete PVI will be achieved when all PV potentials within each antrum recorded by the high-density mapping catheter are abolished. If AF or other sustained atrial tachyarrhythmias persist after complete PVI, ablation of the CTI will be left to the operator's judgement. Direct current cardioversion will then be performed to restore sinus rhythm. The endpoint of the circumferential PVA ablation procedure will be achievement of complete entrance and exit block of all PVAs as recorded by the high-density mapping catheter during sinus rhythm or CS pacing and complete linear block if performed.
15794431|NCT04497363|Device|Brainsonix Pulsar 1002|Each participant will undergo 8 consecutive weekly sessions (each session is 10 minutes long) of focused ultrasound with the Brainsonix Pulsar 1002 device.
15794432|NCT04497350|Device|Transcranial Magnetic Stimulation|5,000 pulses (120-140% MT, continuous temperature of 24C) will be delivered per session (see Appendix A for timing parameters). Patients will have one TMS session per day, five days a week, until their treatment is completed (approximately four weeks).
15794433|NCT04497350|Device|Theta Burst Stimulation|One session of iTBS will deliver 1,800 pulses (120-140% MT, continuous temperature of 22ºC) over an 9-minute-40-second period. The minimum break period between iTBS sessions is 25 minutes.
15794434|NCT04497337|Procedure|Complete excision to superficial lesions around the ear|Complete excision of these lesions and histopathology
15794436|NCT04497311|Diagnostic Test|Thoraxic computed tomography|Diagnostic lung CT.
15794437|NCT04497298|Biological|Two COVID-19 vaccine candidate (TMV-083/V-591) administrations - Low dose|Live-attenuated recombinant measles vaccine virus vector expressing a modified surface glycoprotein of the novel Coronavirus (SARS-CoV-2)
15794438|NCT04497298|Biological|Two COVID-19 vaccine candidate (TMV-083/V-591) administrations - High dose|Live-attenuated recombinant measles vaccine virus vector expressing a modified surface glycoprotein of the novel Coronavirus (SARS-CoV-2)
15794439|NCT04497298|Biological|One COVID-19 vaccine candidate (TMV-083/V-591) administration - High dose|Live-attenuated recombinant measles vaccine virus vector expressing a modified surface glycoprotein of the novel Coronavirus (SARS-CoV-2) and placebo
15794440|NCT04497298|Other|Placebo|Physiological saline solution (0.9% NaCl)
15794441|NCT04497285|Other|blood sample collection and collection of tumor tissue block|blood sample collection and collection of tumor tissue block
15794442|NCT04497272|Other|COVID-19 patients|It will consist in the collection of 1 additional tubes at their blood draw and 1 urine sample.
15794443|NCT04497259|Other|Teleevaluation|Patients will answer to a questionnaire filled through a chatbot link
15794444|NCT04497259|Other|Teleconsultation|A teleconsultation (skype-like connection) at 6 and 9 months after surgery
15794445|NCT04497259|Other|Classical consultation|Patients in the consultation arm will benefit from a classical face to face consultation at 6 and 9 months after surgery.
15794446|NCT04497246|Other|Questionnaire|Data collection by means of various questionnaires
15794447|NCT04497220|Behavioral|Negative Connotation Langauge|"The study intervention consists of two separate scripts read to the patient by the anesthesiologist performing their labor epidural. The control script includes language containing the wording Poke and a burn said prior to numbing medication for the epidural procedure. There will be no difference in the epidural placement, medications, or the rest of the script."
15794448|NCT04497220|Behavioral|Positive Connotation Language|"The study intervention consists of two separate scripts read to the patient by the anesthesiologist performing their labor epidural. The experimental script includes language containing the wording this is numbing medication, which will make the rest of the procedure go easier said prior to numbing medication for the epidural procedure. There will be no difference in the epidural placement, medications, or the rest of the script."
15794449|NCT04497207|Other|Scheimpflug Camera Corneal Tomography|Pentacam Sheimpflug system(Pentacam HR, Oculus Optikgeräte GmbH, software V.1.15r4 n7) is used for imaging of the anterir and posterior surfaces of the cornea to obtain corneal tomographic maps.
15794450|NCT04497194|Other|not applicable (observational study)|not applicable (observational study)
15794451|NCT04497181|Device|Coil embolization surgery|Embolization of aneurysms with various coils system
15794452|NCT04497168|Drug|Citalopram 20mg|20mg daily
15794453|NCT04497168|Drug|Placebo|matching placebo pills
15794454|NCT04497155|Drug|Norepinephrine|Trauma patients with prehospital or arrival to the trauma center hypotension, defined as a systolic blood pressure <100 mmHg, that received norepinephrine during prehospital transport.
15794455|NCT04497142|Drug|Perampanel|Tablet taken orally 1x daily.
15794456|NCT04497142|Drug|Standard of Care|Predetermined standard of care drug and dosing
15794457|NCT04497129|Device|ROMTech PortableConnect|ROMTech PortableConnect (ROMTechPC) therapy will be completed four to five times per day for 6 minutes duration for 6 weeks. The intervention will be administered using the portable rehabilitation unit.
15794458|NCT04497129|Device|Traditional Rehabilitation and CPM Device|Continuous passive motion (CPM) with standard of care HHPT and OPPT rehabilitation program (CPM with SOC). Therapy with the CPM will be completed daily from day 0 through week 3 for a total of 6 to 8 hours per day. The HHPT and OPPT rehabilitation program will be a 6-week program based on SOC goals.
15794459|NCT04497116|Drug|RP-3500|Oral ATR inhibitor
15794460|NCT04497116|Drug|Talazoparib: oral PARP inhibitor|Talazoparib: oral PARP inhibitor
15794461|NCT04497103|Other|control|The traditional therapy included immersing the hand in paraffin for 10 min; soft massaging with a moisturizing gel for 5 min; passive mobilization of the wrist, MP, PIP, and DIP joints; active/passive ROM and stretching exercises; strengthening exercises (done in static mode initially and progressed in the second month to dynamic strengthening using elastic bands); desensitizing sensory stimulation of hypertrophic scars, occupational therapy.
15794462|NCT04497103|Other|Xbox kinect|The traditional plus Xbox Kinect games were related to five target activities determined according to the person-centered analysis results were chosen for each patient.
15794463|NCT04497103|Other|task oriented training|The traditional plus the target activities involved training with the materials (clothes, spoons, pencils, buttons, rope, etc) needed for the activity as well as Velcro cylinders, skill cubes, exercise bands, screw sets, therapeutic putty, and tripled coordination tools.
15794464|NCT04497090|Device|fixed-EPAP|In the fixed-EPAP mode, the device kept EPAP fixed at the prescribed value
15794465|NCT04497090|Device|auto-EPAP|In the Auto-EPAP mode, the device automatically adjusted EPAP to the minimum level able to abolish tidal expiratory flow limitation.
15794466|NCT04497077|Dietary Supplement|tart cherry|Either tart cherry juice or freeze dried powdered tart cherry in capsule was given
15794467|NCT04497077|Dietary Supplement|placebo|either cornstarch capsule or kool-aid
15794468|NCT04497064|Other|survey|survey asking questions regarding breakfast habits and composition, sports nutrition knowledge and exercise habits
15794469|NCT04497051|Diagnostic Test|CT-DSA|CTA before and after embolization
15794470|NCT04497038|Drug|Cabozantinib|Patients will receive therapy with cabozantinib. Dosage in the trial will start at 40 mg PO daily. Each patient will be assessed for the development of toxicity according to the NCI Common Terminology Criteria for Adverse Events, version 5.0. Dose adjustments may be made per the Time-To-Event modification of the Continual Reassessment Method (TITE-CRM). The maximum dosage will be 60 mg PO daily and the minimum will be 20 mg PO daily.
15794471|NCT04497025|Other|Immersive Virtual-based vestibular rehabilitation|Vestibular rehabilitation based on virtual environment using a head mounted display
15794472|NCT04497025|Other|Conventional vestibular rehabilitation protocol|"Cawthorne-Cooksey vestibular rehabilitation exercises."
15794473|NCT04497012|Drug|2mg/kg/day Iron Sulfate|Iron Sulfate will be given in liquid form via nasal or oral gastric tube with feeds.
15794474|NCT04497012|Drug|6 mg/kg/day Iron Sulfate|Iron Sulfate will be given in liquid form via nasal or oral gastric tube with feeds.
15794475|NCT04496999|Drug|HDM201|Dose level 0: HDM201 40 mg QD d1,2 (midday)/ Dose level 1: HDM201 40 mg QD d1,2,3 (midday) = Starting dose/ Dose level 2: HDM201 40 mg QD d1,2,3,4,5 (midday)/ Dose level 3: HDM201 60 mg QD d1,2,3,4,5 (midday)/ Dose level 4: HDM201 80 mg QD d1,2,3,4,5 (midday)
15794476|NCT04496999|Drug|Midostaurin|Midostaurin 50mg bid d1-28 (morning, evening)
15794477|NCT04496986|Diagnostic Test|Fiberoptic Endoscopic Evaluation of Swallowing|This procedure involves inserting a flexible laryngoscope that contains a light source and video camera on the end through the open passage of the nose towards the back of the throat in order to visualize the swallowing mechanism.
15794478|NCT04496986|Diagnostic Test|Simultaneous FEES and Videofluoroscopy instrumental swallowing exam|This procedure involves inserting a flexible laryngoscope that contains a light source and video camera on the end through the open passage of the nose towards the back of the throat in order to visualize the swallowing mechanism. The participant will be asked to perform some voicing tasks, once completed, a videofluoroscopic swallowing exam will occur at the same time. This is like moving x-ray of the participant swallowing foods and liquids (barium).
15794479|NCT04496986|Other|Voluntary Cough Peak Expiratory Flow (PEF) Testing|Cough PEF will be performed to index a participant's physiologic airway defense capacity and strength. Testing will occur with the participant seated upright at 90 degrees using an analog peak flow meter with a one-way expiratory valve that prevents a participant from breathing air in from the device to reduce contamination.
15794480|NCT04496986|Other|Reflex Cough Screen|Participants will be seated upright and administered reflex cough testing via a disposable adult aerosol mask with an attached nebulizer that contains a solution to elicit a cough response.
15794481|NCT04496986|Other|Lingual Pressure Testing|Lingual strength will be evaluated using the Iowa Oral Pressure Instrument (IOPI). Participants will be seated upright, and the SLP will place the IOPI air-filled sensing bulb in the midline anterior position on the participant's tongue, posterior to the alveolar ridge.
15794482|NCT04496986|Diagnostic Test|Speech Testing|"Speech assessment will occur with the participant comfortably seated headset microphone with a lapel windscreen connected to a TASCAM DR40 to allow for high-quality audio recordings. Individuals will be asked to perform two maximal performance speech tasks that include vowel prolongation of /a/, and a Diadochokinetic (DDK) rate task to examine SMR for production of the word buttercup."
15794483|NCT04496960|Drug|tofacitinib|XELJANZ(R) is the citrate salt of tofacitinib. Tofacitinib citrate is a white to off-white powder with the following chemical name: (3R,4R)-4-methyl-3-(methyl-7H-pyrrolo [2,3-d]pyrimidin-4-ylamino) -beta-oxo-1-piperidinepropanenitrile, 2-hydroxy-1,2,3-propanetricarboxylate (1:1) It is freely soluble in water and has a molecular weight of 504.5 Daltons. XELJANZ(R) is supplied for oral administration as 5 mg tofacitinib (equivalent to 8 mg tofacitinib citrate) white round, immediate-release film-coated tablet. Each tablet of XELJANZ(R) contains the appropriate amount of XELJANZ(R) as a citrate salt and the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, croscarmellose sodium, magnesium stearate, HPMC 2910/Hypromellose 6cP, titanium dioxide, macrogol/PEG3350, and triacetin.
15794484|NCT04496960|Other|Placebo|white, round, film-coated tablet
15794485|NCT04496947|Behavioral|Stress Reduction|"The stress reduction program is a multimodal mind-body resiliency program that incorporates 3 core components into each session:
~Elicitation of the Relaxation Response (RR) through mind-body techniques;
~Discussion about stress awareness to learn how to identify personal stressors and experiences of stress; and
~Coping strategies and adaptive perspective-taking to promote positive well-being."
15794486|NCT04496934|Behavioral|Exercise|Exercise of choice with a training contact: 3 hrs/week, total of 12 weeks.
15794487|NCT04496921|Dietary Supplement|Vitamin K supplementation, dose #1|Vitamin K supplement : 2mg, once a day, for 6 months. Complete biochemical profile, weight and size (body mass index), drugs list, pulmonary function by spirometry (FEV, etc.). Food frequency questionnaire.
15794910|NCT04493359|Drug|Renin-angiotensin system inhibitors|switch anti-hypertensive class
15794490|NCT04496908|Device|Foley Catheter|Foley catheter device is commonly used for cervical ripening during labor induction. It is used independently or in combination with pharmacologic augmentation. It is inserted in the cervix and the balloon is then inflated with 60 cc of saline.
15794491|NCT04496908|Drug|Misoprostol|Misoprostol is a medication that is commonly used for cervical ripening during labor induction. It is commonly used independently or in combination with mechanical methods, such as a foley catheter. The commonly used dose during term labor induction is 25 mcg.
15794494|NCT04496882|Drug|Vemlidy|25mg Tenofovir Alafenamide
15794495|NCT04496869|Other|Online questionnaire|the investigators sent by email a Googleform online questionnaires to women followed in ART center of HFME (Hospital Femme-Mère-Enfant) . Questions are about demographic characteristics, ART history, feeling during the lockdown. To evaluate psychological impact, the investigators use PSS10 and HADS scales. Both scales are worldwide validated and used in recent COVID19's research. the investigators add some quantitative questions about de feeling during the look down, ART interruption, pregnancy desire.
15794496|NCT04496856|Dietary Supplement|Whey protein and Collagen supplementation|Participants of each arm will consume 30 g daily of the assigned protein supplementation for 30 days. The protein supplementation will be given as protein powder which the participants will have to dissolve in cold drinks. During the intervention fat free mass, muscle strength, functional ability, wound healing and life quality of the participants will be monitored.
15794497|NCT04496843|Diagnostic Test|HWA09 Measurement|Simultaneous recording of Withings HWA09 Device and PSG devices for the reference.
15794498|NCT04496830|Device|SOMAscan|Analysis of previously donated cerebrospinal fluid using a SOMAscan assay
15794499|NCT04496817|Other|Docosahexaenoic Acid and Lutein Enriched Eggs|Consumption of 2 docosahexaenoic acid and lutein enriched eggs daily (at least 5 days our week) for 6 weeks
15794500|NCT04496817|Other|Regular Eggs|Consumption of 2 non enriched eggs daily (at least 5 days our week) for 6 weeks
15794501|NCT04496804|Behavioral|Behavioral Intervention for Physical Activity in MS (BIPAMS)|A behavioral intervention that involves an Internet website and one-on-one video coaching calls for increasing physical activity in people with MS.
15794502|NCT04496804|Behavioral|Wellness for MS (WellMS)|A behavioral intervention that involves an Internet website and one-on-one video coaching calls for increasing wellness in people with MS.
15794503|NCT04496791|Device|RIC (Receiver in Canal) hearing aid/ hearing instrument (HI)|HI is developed to support hearing impaired people in calm and complex situations and to be able to participate in communication
15794504|NCT04496778|Device|low level laser therapy ( laser acupuncture combined with nasal laser irradiation)|"Cold Laser Therapy Watch (Laser Watch- 650 nm) combines acupuncture and nasal cavity for external blood irradiation. Laser watch with 10 laser beams - is applied to the left wrist.
~Nasal Probe with 2 laser beams - is applied to the nose cavity"
15794505|NCT04496778|Other|aerobic exercise|3 d/week for 45 to 60 minutes per session for 3 months. started by 40%-50% Heart Rate Reserve (determined by using a walking treadmill exercise test) during the first 6 weeks increasing gradually up to 50%-70% Heart Rate Reserve
15794506|NCT04496765|Procedure|Total mesorectal excision|Radical resection of rectal cancer and draining lymph nodes
15794507|NCT04496739|Behavioral|Cancer Educational Materials|Receive educational materials about breast cancer risk and chemoprevention via RealRisk
15794508|NCT04496739|Other|Decision Aid|Given patient-centered decision support via an action plan
15794509|NCT04496739|Other|Decision Aid|Given decision support and action plans based on patient's interactions with RealRisks via the BNAV support tool
15794510|NCT04496739|Other|Interview|Participate in audio-recorded interview via telephone or video conference
15794511|NCT04496739|Other|Questionnaire Administration|Ancillary studies
15794512|NCT04496726|Other|Pacran and Sapnov P quillaja|Cranberry (450 mg) and quillaja (50 mg) capsules taken orally twice daily (morning and evening) for a total daily dose of 900 mg cranberry and 100 mg quillaja for 14 days. Nitrofurantoin 100 mg taken orally twice daily for five days as a rescue medication if symptoms do not subside.
15794513|NCT04496713|Other|Internet-connected computer tablet|An internet-connected tablet provided to patient for upcoming visit with physician by audio/video which can also be used to complete a survey.
15794514|NCT04496700|Procedure|Whole blood donation and transfusion|"The effect of whole blood donation on physical performance:
~Donation of 450 ml whole blood - one time only."
15794515|NCT04496674|Drug|CC-1 and Toczilizumab|Adminsitration of CC-1 and Toczilizumab
15794516|NCT04496661|Device|Transcranial Direct Current Stimulation on M1 and Peripheral Electrical Stimulation|Patients will be submitted to 10 treatment sessions, five days a week, for 30 minutes, paired to the same PES protocol. The participants will be positioned in ventral decubitus position. The direct current (2 mA) will be transferred through a neuro-stimulator (TransCranial Technologies, Hong Kong, China), with the use of electrodes and 4x4 cm sponges moistened with 0.9% saline solution. The anodic electrode will be placed on C3 to stimulate the left primary motor cortex according to the international 10-20 EEG system. The reference electrode will be positioned in the supra orbital contralateral region. For the PES, four self-adhesive electrodes with dimensions of 5 x 5 cm will be placed at the height between the T12 and S1 vertebrae in order to cover the entire lumbar area. A 20Hz frequency and pulse duration of 330ms will be provided by means of two channels from an electro-stimulator (Neurodyn, Ibramed).
15794517|NCT04496661|Device|Transcranial Direct Current Stimulation on DLPFC and Peripheral Electrical Stimulation|Patients will be submitted to 10 treatment sessions, five days a week, for 30 minutes, paired to the same PES protocol. The direct current (2 mA) will be transferred through a neuro-stimulator (TransCranial Technologies, Hong Kong, China), with the use of electrodes and 4x4 cm sponges moistened with 0.9% saline solution. The anodic electrode will be placed on F3 to stimulate the left dorsolateral cortex according to the international 10-20 EEG system. The reference electrode will be positioned in the supra orbital contralateral region. For the PES, four self-adhesive electrodes with dimensions of 5 x 5 cm will be placed at the height between the T12 and S1 vertebrae in order to cover the entire lumbar area. A 20Hz frequency and pulse duration of 330ms will be provided by means of two channels from an electro-stimulator (Neurodyn, Ibramed).
15794915|NCT04493307|Diagnostic Test|Phlebotomy|Serial assessment of hemostasis by blood and urine collection
15794518|NCT04496661|Device|Sham tDCS and PES|For sham tDCS and PES stimulation, patients will be submitted to 10 treatment sessions, five days a week, for 30 minutes. The anodic electrode will be positioned on the left primary motor cortex, but the current will be turned off automatically after 30 seconds. The reference electrode will be positioned in the supra orbital contralateral region. For sham PES stimulations, four self-adhesive electrodes with dimensions of 5 x 5 cm will be placed at the height between the T12 and S1 vertebrae in order to cover the entire lumbar area. A 20Hz frequency and pulse duration of 330ms will be provided by means of two channels from an electro-stimulator (Neurodyn, Ibramed), but the current will be turned off automatically after 30 seconds.
15794519|NCT04496648|Procedure|Percutaneous Coronary Intervention|Percutaneous coronary intervention with drug-eluting stents and modern techniques
15794520|NCT04496648|Procedure|Sham-percutaneous coronary intervention|Sham-PCI procedure for at least 15 minutes that includes shifting the C-arm, reinserting the FFR-wire in the catheter and inflating the device.
15794521|NCT04496635|Other|Implementation of a bundle of care|
15794522|NCT04496622|Other|WBV technique|"Whole body vibration with frequency of 16-25 Hz were given from week 1-8 for 10 minutes/10 repetitions. Time were increased weekly Convention therapy were hot pack 10 minutes, stretching exercise (SLR) 10 repetition x 3 sets and quadriceps exercise 10 repetition x 3 sets.
~3 session/week for 8 weeks"
15794523|NCT04496622|Other|Whole body vibration technique|"Whole body vibration with frequency of 26-35 Hz were given from week 1-8 for 10 minutes/10 repetitions. Time were increased weekly Convention therapy were hot pack 10 minutes, stretching exercise (SLR) 10 repetition x 3 sets and quadriceps exercise 10 repetition x 3 sets.
~3 session/week for 8 weeks"
15794524|NCT04496609|Device|Stimulation and automated rehabilitation / automated rehabilitation|Stimulation and automated rehabilitation for 40 working days, then washout during 30 days, then automated rehabilitation for 40 working days
15794525|NCT04496609|Device|Automated rehabilitation / Stimulation and automated rehabilitation|Automated rehabilitation for 40 working days, then washout during 30 days, then automated rehabilitation for 40 working days
15794526|NCT04496596|Drug|Suramin|Suramin is administered via IV infusion as a single dose of 3 mg/kg
15794527|NCT04496596|Drug|Placebo|Placebo
15794528|NCT04496583|Other|Fluid depletion strategy|The fluid depletion strategy will be individualized depending on the response to the standardized furosemide test (one-time dose of 1.0 or 1.5 mg/kg depending on prior furosemide-exposure) with a urinary output (UO) cutoff of 200 ml at 2 hours. The desired depletion endpoint will be targeted by using diuretics (40 mg q6h iv initially, adjusting dose by UO) or ultrafiltration (UF) if UO <200 ml/2h
15794529|NCT04496570|Procedure|periodontal therapy|Non surgical periodontal therapy was performed to patients with peridontitis
15794530|NCT04496557|Device|PROCESS-INSTRUCTED SELF NEURO-MODULATION (PRISM)|"Neurofeedback sessions targeting down-regulation of deep limbic structures, specifically the amygdala, delievered via PRISM: a non-significant risk device (software) intended to be used in research studies testing the clinical efficacy of an innovative paradigm for EEG-based neurofeedback.
~The study will include 12 EEG-NF sessions, administered twice per week for a duration of 6 active weeks in total. Twice weekly sessions will be held on non-consecutive days. Each session will last 30 minutes.
~EFP-EEG-NF training: Each NF training session consists of 5 consecutive sequences of NF presentations. During a watch condition (60 seconds) participants are instructed to passively view the animation, and are told that that the scenario does not influence their brain activity. In the regulate phase (60 seconds) participants are instructed to lower the room's unrest level. A rest phase (15 seconds) follows each sequence, allowing participants to relax."
15794531|NCT04496544|Other|Retrospective data collection|No intervention; retrospective data collection
15794532|NCT04496531|Device|Portable Neuromodulation Stimulator|
15794533|NCT04496518|Device|Intrinsic Antitachycardia Pacing (iATP) Therapy|iATP is a fully automated ATP therapy for monomorphic ventricular tachycardia (MVT).
15794534|NCT04496505|Device|Device|is a mask that uses sequences of flashing lights and analogous sounds to trigger a relaxed state in those with intense pain. Pilot studies have so far shown a statistically significantly decrease in pain, anxiety and opiate withdrawal, as well as an increase in heart rate variability. Preliminary data shows a statistically significant decrease in depression symptoms as measured by Patient Health Questionnaire 9 (PHQ-9) scale .
15794535|NCT04496505|Device|Sham Device|The sham treatment device was designed to copy the look and feel of thetherapy to a degree that it would be indistinguishable from the true treatment. The sham treatment delivers a series of Audio-Visual Stimulation (AVS) in the form of pulses of light (through closed eyelids) and sound, but that offer no therapeutic effect.
15794536|NCT04496492|Drug|Tocotrienol|Tocotrienol 200 mg orally twice a day
15794537|NCT04496479|Biological|LYG-LIV0001|Allogenic hepatocytes suspended in a buffered cell preservation solution with increasing number of lymph nodes being transplanted for the dose escalation. Subjects will also receive immune suppression, including tacrolimus capsules to follow the dose prescribed by the investigator as well as a short course of prednisone.
15794538|NCT04496453|Other|Childhood vaccination decision support tool|Participants receive childhood vaccination decision support tool
15794539|NCT04496440|Other|Contracture Correction Therapy|Non-drug and non-surgical treatment of contracted knee capsules
15794540|NCT04496414|Device|Bactiseal Catheter|Bactiseal Catheter manufactured by Codman & Shurtleff, Inc. in the United States is a silicon catheter impregnated in rifampicin and clindamycin.
15794541|NCT04496401|Drug|Tacrolimus and Tacrolimus Extended Release Oral Tablet [Envarsus]|"Phase 1: standard dose and frequency tacrolimus, used in accordance with licensing and local protocols. Suitable target trough level should be between 7-14 ng/ml.
~Phase 2: ENVARSUS® (LCP Tacro - extended release tacrolimus), used once-daily at an initial dose of 0.17mg/kg, dose adjusted to maintain an appropriate therapeutic blood concentration (measured by trough level). Suitable target trough level should be between 7-14 ng/ml."
15794542|NCT04496388|Behavioral|exercise|different type of exercise
15794543|NCT04496388|Behavioral|No exercise intervention|No exercise intervention
15794544|NCT04496375|Other|Survey|Self-completed questionnaires
15794773|NCT04494425|Drug|Capecitabine|Investigator's choice standard of care single agent chemotherapy; capecitabine tablets will be given orally.
15794774|NCT04494425|Drug|Paclitaxel|Investigator's choice standard of care single agent chemotherapy; paclitaxel by intravenous infusion.
15794545|NCT04496362|Drug|subcutaneous heparin anticoagulation|The primary objective of this study is to evaluate the safety and efficacy of subcutaneous heparin anticoagulation compared to the standard of care systemic intravenous anticoagulation during veno-venous extracorporeal membrane oxygenation for respiratory failure. Subjects will be prospectively randomized in 1:1 ratio to subcutaneous heparin anticoagulation or systemic intravenous anticoagulation and followed until 1 week after discontinuation from ECMO support.
15794548|NCT04496323|Other|EE Golf|Exercise in Golf and Playing 9 holes
15794549|NCT04496310|Procedure|Telemedicine|Telemedicine versus usual care (face to face visit)
15794550|NCT04496284|Other|Vitrification via slush nitrogen|blastocyst stage embryos will be vitrified via slush nitrogen
15794551|NCT04496271|Device|RIC (Receiver in channel)- device|HI is developed to support hearing impaired people in calm and complex situations and to be able to participate in communication
15794552|NCT04496258|Behavioral|Positive Emotion Induction|Participants are expected to have a positive emotional response to the more positive beach scene.
15794553|NCT04496258|Behavioral|Neutral Emotion Induction|Participants are expected to have a neutral emotional response to the neutral office scene.
15794554|NCT04496245|Drug|Broncho-Vaxom®|Broncho-Vaxom adult capsules® (OM85)
15794555|NCT04496232|Device|PICSI|Semen processing by density gradient centrifugation followed by sperm selection by PICSI dishes of the first ejaculate
15794556|NCT04496232|Other|Second ejaculate|Semen processing by density gradient centrifugation for the second ejaculate
15794557|NCT04496219|Device|Acupuncture Therapy|Undergo acupuncture therapy
15794558|NCT04496219|Biological|BCG Solution|Given by intravesical injection
15794559|NCT04496219|Other|Best Practice|Receive standard of care symptom management
15794560|NCT04496219|Other|Quality-of-Life Assessment|Ancillary studies
15794561|NCT04496219|Other|Questionnaire Administration|Ancillary studies
15794562|NCT04496206|Other|No intervention|No intervention, it is retrospective study.
15794563|NCT04496193|Procedure|Quadratus Lumborum block|Quadratus Lumborum block is a type of plane block where local anesthetic is injected adjacent to the quadratus lumborum muscle with the goal of anesthetizing the thoracolumbar nerves.
15794564|NCT04496180|Device|Closed incision negative pressure therapy versus standard dressing after emergency abdominal laparotomies|"Target population is every patient undergoing a laparotomic procedure and responding to inclusion criteria marked in paragraph 3.8 (see forward) A member of the medical surgery team should apply the PREVENA just after the surgical procedure.
~A medical member (nurse specialist in wound care) of the surgical team removes the dressing. All other manipulations of the therapy unit, the connector and the cartridge can be carried out by any nurse practitioner in hospital or extra hospital environment but must warn the investigators.
~The aspiration will be stopped 24 hours before and the dressing is removed by a nurse at home or in the hospital.
~The specialized nurse who will take a photo and assess the condition of the wound in the treatment room.
~One of the investigators, non-operators, who will also assess the condition of the wound by photo."
15794565|NCT04496167|Drug|EN3835|Collagenase clostridium histolyticum or placebo comparator
15794566|NCT04496154|Dietary Supplement|Omega-3 fatty acids (2.7 g/d, EPA:DHA, 2:1)|Triple Strength Omega-3 from Webber Naturals
15794567|NCT04496141|Diagnostic Test|SARS-CoV-2 antibody immunoassays|Different commercial SARS-CoV-2 antibody immunoassays
15794568|NCT04496115|Behavioral|Mindfulness|Mindfulness training
15794569|NCT04496102|Device|Triathlon|Modern TKA design (Triathlon) with patellar resurfacing
15794570|NCT04496089|Diagnostic Test|89Zr-girentuximab|A single dose of 37 MBq (±10%) is administered. The dose per dose is equivalent to girentuximab 10 mg (±10%).
15794571|NCT04496063|Drug|Ustekinumab|Intravenous induction (6mg/kg) followed by Ustekinumab subcutaneous 90mg every 8 weeks
15794572|NCT04496063|Drug|Placebo|Placebo intravenous followed by Placebo subcutaneous every 8 weeks
15794573|NCT04496050|Drug|Prostaglandin E1|The same drug will be used. In this study the same patients will be evaluated after the same dose of medication.
15794574|NCT04496037|Drug|Rituximab|See NCT03994783
15794575|NCT04496024|Drug|ofloxacin|ofloxacin treatment in patients with bone and joint infections
15794576|NCT04496024|Other|questionnaire|questionnaire of ofloxacine side effects will be completed by the clinician at Day 3, Day 21 and Day 42
15794577|NCT04496024|Biological|Ofloxacin Serum concentration|Serum concentration of ofloxacin will be measured at Day 3 (Cmin and Cmax), Day 21 and Day 42 (Cmin).
15794578|NCT04496011|Other|Aerobic training with cycle ergometer|Patients start with an initial warm-up of 2 minutes, with rotations per minute free, without load. Progressively, the load of the exercise cycle increases every minute up to the supported limit or up to 60% - 70% of maximum heart rate (HRmax). The training will be carried out for 20 continuous minutes, being interrupted whenever the heart rate (HR) reaches 90% of the maximum expected for the age and / or the loss of effort perceived in the BORG scale, above 8 on a scale of 0 to 10.
15794579|NCT04495998|Diagnostic Test|Brief Motor Scale_portuguese version (BMS_pt)|translate, adapt and validate Brief Motor Scale for portuguese population with schizophrenia
15794580|NCT04495972|Dietary Supplement|Intestinimonas-capsules|Capsules containing microbiota (Intestinimonas)
15794581|NCT04495972|Dietary Supplement|Placebo-capsules|Placebo capsules are identical to the active treatment
15794582|NCT04495959|Drug|18F-DCFPyL|PET/MRI scan with radiotracer 18F-DCFPyL
15794583|NCT04495946|Behavioral|Sepsis Transition and Recovery (STAR) program|In the STAR program intervention, a centrally located nurse navigator facilitates the application of four evidence-based core components of post-sepsis care (i.e., review of medications, new impairments, comorbidities, and palliative care) to patients prior to and during the 90 days after hospital discharge. The STAR navigator will provide telephone and EHR-based support within the hospitalization and to patients across all discharge settings with remote monitoring at specified intervals following hospital discharge. Patients will continue to receive STAR directed services for 90 days following their discharge and then will be transitioned back to the next appropriate care location.
15794775|NCT04494425|Drug|Nab-Paclitaxel|Investigator's choice standard of care single agent chemotherapy; nab-paclitaxel by intravenous infusion
15794584|NCT04495946|Behavioral|Usual care|Hospitals and their patients will not have access to the STAR program. Patients will continue to receive usual care throughout their stay and discharge, consisting of: patient education and follow-up instructions at discharge, which are not specific to sepsis; routine recommendations for follow-up visits with primary care providers; arrangements for home health services or care management follow-up based on each patient's needs but not specifically tailored to the sepsis population; discharge to post-acute setting with no sepsis-specific follow-up. All aspects of usual care will be determined by treating clinicians independent of trial assignment.
15794585|NCT04495933|Biological|MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 5mcg|MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 5mcg
15794586|NCT04495933|Biological|MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 15mcg|MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 15mcg
15794587|NCT04495933|Biological|MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 45mcg|MF59 adjuvanted SARS-CoV-2 Sclamp vaccine 45mcg
15794588|NCT04495933|Other|Placebo|sterile saline
15794589|NCT04495920|Drug|CGB-S-100|Alcohol and choline geranate
15794590|NCT04495894|Drug|Preoperative Ketorolac|30 mg ketorolac will be administered intravenously 30 minutes prior to incision.
15794591|NCT04495881|Drug|Sitagliptin 100mg|Sitagliptin 100mg Qd
15794592|NCT04495868|Drug|Bacteriostatic Normal Saline|A skin wheal will be made with bacteriostatic normal saline (BNS). BNS contains 0.9% benzyl alcohol and benzyl alcohol is an opium alkaloid that is sometimes added to physiologic normal saline for its bacteriostatic properties. The skin wheal will be created by injecting the medication intra-dermally with a 26 gauge needle.
15794593|NCT04495868|Drug|1% Lidocaine|A skin wheal will be made with 1% lidocaine. The skin wheal will be created by injecting the medication intra-dermally with a 26 gauge needle.
15794595|NCT04495842|Other|Essential Oil Blend|5 drops of on a tester strip
15794596|NCT04495842|Other|Control Blend|5 drops on a tester strip
15794597|NCT04495829|Device|Phorcides Analytical Engine|Surgery planning using the Phorcides analytical engine.
15794598|NCT04495816|Drug|Omega-3 Fatty Acid Supplement|Participants randomized to this arm will be instructed to take two of the softgels they received per day for 6 weeks. They will receive softgels containing 1,000 mg of omega-3 fatty acid. 1000 mg of omega-3 fatty acid blend including 683 mg Eicosapentaenoic Acid and 252 mg Docosahexaenoic Acid
15794599|NCT04495816|Drug|Placebo/Control|Patients randomized to this arm will also be instructed to take two of the softgels they received per day for 6 weeks. They will receive placebo softgels that are indistinguishable from those containing fish oil.
15794600|NCT04495803|Other|Cognitive Behavioural Group Therapy for Perinatal Anxiety|The treatment consists of cognitive and behavioural strategies for treating anxiety, tailored specifically to a perinatal/postpartum population. Additional strategies for COVID-19 specific worry content have been included.
15794601|NCT04495777|Other|Fonseca Anamnestic Index|"Fonseca Anamnestic Index was developed to assess the severity of temporomandibular disorders, based on its signs and symptoms. It has been proposed as a low cost and easy to apply alternative and has been used in screening for TMD in a non-patient population5. It was created with 10 items with 3 options of answers (specific scores): yes (10 points), sometimes (5 points) and no (0 points). The final score of the instrument is determined by the sum of the scores of all items, allowing the following classifications: the absence of signs and symptoms of TMD (0-15 points), mild TMD (20-45 points), moderate TMD (50-65 points), and severe TMD (70-100 points) (19)."
15794606|NCT04495738|Other|Control Infant Formula|Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age
15794607|NCT04495738|Other|Control Toddler Drink|16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age
15794608|NCT04495738|Other|Experimental Infant Formula|Ad libitum or as instructed by HCP, feeding period from enrollment to 12 months of age
15794609|NCT04495738|Other|Experimental Toddler Drink|16 fl oz per day as primary milk beverage; feeding period from 12 to 24 months of age
15794610|NCT04495738|Other|Supplemental Formula for HM Group|Ad libitum formula given up to 12 months of age if HM is supplemented
15794611|NCT04495738|Other|Toddler Drink for HM group|16 fl oz per day if weaned from HM feedings
15794612|NCT04495725|Other|Discounted Vouchers for Medical Cannabis Soft-Gel Capsule Products|We will randomize participants to one of the following four conditions for discounted vouchers: 1) a discounted voucher for a placebo soft-gel capsule product, 2) a discounted voucher for a high THC:low CBD soft-gel capsule product, 3) a discounted voucher for an equal THC:CBD soft-gel capsule product, or 4) a discounted voucher for a low THC:high CBD soft-gel capsule product. We will stratify randomization by history of cannabis use (no use in the past year, used in the past year and not near-daily or daily (used in the past year and <20 days out of the last 30 days), near-daily or daily (>= 20 days out of the last 30 days) baseline opioid analgesic prescription (chronic opioid treatment vs. not chronic opioid use), and primary pain condition (neuropathy, not neuropathy). Chronic opioid treatment is defined as prescribed opioids ≥90 non-overlapping days in the past 182 days. Randomization will occur in blocks to ensure equal randomization over time.
15794613|NCT04495712|Drug|spironolactone|aldosterone blocker
15794614|NCT04495712|Drug|placebo|identical in appearance to spironolactone study drug
15794615|NCT04495699|Other|None - observational|If the patient elects to have their stone treated, it will be treated in the usual most clinically appropriate fashion (Shockwave lithotripsy, ureteroscopy, or percutaneous nephrolithotomy). All types of treatment will be analyzed together.
15794675|NCT04495192|Genetic|Genetic analysis of different single nucleotide polymorphisms on ApoE, BDNF and DRD2 genes assessment|Genomic DNA will be obtained from EDTA-whole venous blood sample by Automated Systems QiaCube (Qiagen). The genetic analysis of 5 different single nucleotide polymorphisms on ApoE, BDNF and DRD2 genes will be performed by HRM analyses and direct sequencing on Automatic Genetic Analyzer. All the aliquots will be amplified by a real-time PCR. The genetic polymorphism data will be compared to sex- and age-matched control of the DNA banking of the neurogenetic Laboratory of Florence Hospital.
15794676|NCT04495179|Drug|AZD4635|Subjects will receive AZD4635 orally daily
15794616|NCT04495686|Behavioral|Telehealth-delivered Care Coordination Program|"Participants in the interventional arms of this program will be assigned a Dementia Care Manager (DCM) who will work with caregivers to develop goals and plans that are aimed at providing the best support possible, specific to your needs. These services include supportive counseling, education on dementia, information and referrals to community-based organizations, behavioral symptom management training and assistance with finding available community and government-sponsored programs.
~DCM's will meet with you at least once monthly and will be available if you need assistance between meetings. At the first meeting, your DCM will explain the questionnaires you will take and how to use the technology in the program. They will then provide a link, via email, where you will download the free teleconferencing software that will be used throughout the program. Questionnaires will then be sent via email invitations through a secure survey platform."
15794617|NCT04495673|Device|Transcranial Direct Current Stimulation (tDCS)|Participants receive 10 sessions (2 5-visit blocks of 46 minutes) of active tDCS to DLPFC (dorsolateral prefrontal cortex)
15794618|NCT04495673|Device|Sham Transcranial Direct Current Stimulation (tDCS)|Participants receive 10 sessions (1 5-visit block of 46 minutes of active tDCS and 1 5-visit block of sham tDCS)
15794619|NCT04495673|Behavioral|Cognitive Training|Executive functioning tasks
15794620|NCT04495660|Device|Near InfraRed Spectroscopy (fNIRS)|Functional neuroimaging examination by fNIRS at each follow-up visit for all children of both cohorts: this non-invasive imaging technique involves the installation of a cap carrying electrodes to collect brain activity on the surface of the scalp , during stimulation. It is very insensitive to movement and therefore represents a method particularly suitable for its use in children. In addition, this technique is compatible with the cochlear implant. It will be used during 6 tasks adapted to each cohort
15794621|NCT04495660|Behavioral|Passive perceptual stimulation|Passive perceptual stimulation: For this passive task the child is on his parents' lap in front of a screen. He will see images, hear everyday noises and watch small videos. Duration 8-10 minutes.
15794622|NCT04495660|Behavioral|Task A not B|Task A not B: the child will play with an adult who will hide an object under a cloth several times. The child will have to find the hidden object. Duration 10 minutes maximum
15794623|NCT04495660|Behavioral|VSWMT task|VSWMT task: the child will be on the parents' lap in front of a screen and will watch a monkey hiding bananas in the trees several times. Duration of 10 minutes maximum.
15794624|NCT04495660|Behavioral|Perceptual Go-No-Go|Perceptual Go-No-Go: This perceptual task consists in the discrimination of images (faces) and sounds (words) through 3 conditions (auditory, visual and visuo-auditory) presented independently of each other and lasts 15 to 20 minutes in total. It is presented by means of a computer
15794625|NCT04495660|Behavioral|Verbal memory task|Verbal memory task :the child will be presented with 5 lists of 5 words which he will have to restore after a predefined delay of a few seconds. Its duration does not exceed 10 minutes.
15794626|NCT04495660|Behavioral|The sensory room|The sensory room: the child will sit in the middle of a carpet and play with the adult. He will hear everyday noises and see light effects. Duration 8-10 minutes
15794627|NCT04495647|Other|Whole-Body Electromyostimulation|"Whole-Body Electromyostimulation (WB-EMS): Simultaneous, individually adjustable stimulation of 12 muscle groups using an interval approach with a duty cycle of 6s impulse/4s rest, bipolar electric current (impulse -frequency 85Hz, -width 350μs, rectangular pattern) will be applied.
~After a 4-week conditioning period, 1.5x 20 min/week WB-EMS will be conducted for 4 weeks (total training duration 8 weeks). Easy to perform functional exercises focusing on balance, transfer ability, stepping and lower extremity strength/power will be done during WB-EMS. Exercise intensity will be individually prescribed and adjusted by rate of perceived exertion (RPE-Borg CR10 scale 4 (moderate) to 7 (hard)).
~WB-EMS will be fully supervised one on one.
~All three arms will receive the same intervention."
15794628|NCT04495634|Device|Stationary Head CT (s-HCT)|The system consists of a total of three x-ray sources and nine x-ray detectors with an estimation of approximately 150 projection angles per slice, with less than a minute per slice reconstruction. Radiation dose will be configured as to not exceed that of a conventional head CT, or 2 mSv. The subjects will be positioned on a medical procedure table that will move the subject through the scanning system at the rate of roughly 1 cm per second, during which the necessary x-ray projections will be acquired. The head will be positioned in a carbon fiber head holder from a clinical CT scanner that is secured to the table.
15794629|NCT04495621|Drug|MEN1611|MEN1611 oral dose administered twice daily for a continuous 28-day cycle.
15794630|NCT04495621|Drug|Cetuximab|Cetuximab solution for infusion administered weekly via IV infusion.
15794631|NCT04495608|Drug|Fluconazole|"Fluconazole 50 mg/capsule or placebo, per os during 18 weeks :
~From W0 to W2 : 1 caps/ day
~From W2 to W4 : 1 or 2 caps/day
~From W4 to W6 : 1, 2 or 3 caps/day
~From W6 to W18 : 1, 2, 3 or 4 caps/day
~The number of capsules to take will be determined by 24-hours calciuria results performed every 2 weeks during the titration period (W2, W4 and W6).
~During the titration period, if 24-hours calciuria is > 0.1 mmol/kg/day, fluconazole dose will be increased every 2 weeks to 50 mg per intake, with a maximum dose of 200 mg/day. If 24-hour calciuria is ≤ 0.1mmol/kg/day, fluconazole dose will remain stable.
~After W6 and until the end of the study, the treatment dose will remain stable (stable period)."
15794632|NCT04495608|Drug|Placebo|Placebo (1, 2, 3 or 4 pills to take daily during 18 weeks), same appearance to experimental drug
15794633|NCT04495595|Other|No intervention|There is no intervention due to the observational, cross-sectional design of the study
15794634|NCT04495569|Biological|recombinant anti-rabies human monoclonal antibody injection (SYN023)|The finished product of SYN023 is a mixture of two anti-rabies human monoclonal antibodies, CTB011 and CTB012 by equal quantity, containing 3.0 mg/mL active ingredients in both.
15794635|NCT04495569|Biological|Rabies Vaccine|The Chinese licensed Vero Cell Freeze-dried Rabies Vaccine was injected to Cohort B as per the vaccination precedure on Days 1, 4, 8, 15, 28 respectively.
15794636|NCT04495556|Diagnostic Test|MRI|The study will include MRI at baseline (first study visit) and month 24 (final study visit). MRI at month 24 (end of study) will be used to determine McDonald Criteria and final review of CVS.
15794677|NCT04495179|Drug|Durvalumab|Subjects will receive intravenous durvalumab every 4 weeks for Arm A and every 3 weeks for Arm B.
15794678|NCT04495179|Drug|Cabazitaxel|Subjects will receive intravenous cabazitaxel every 3 weeks
15794776|NCT04494412|Drug|Zanamivir|Zanamivir solution for infusion will be available as a 10 milligrams per milliliters (mg/mL) vial.
15794637|NCT04495543|Behavioral|Brief Skills for Safer Living|Brief-SfSL is a single-session individual therapy adaptation of the core goals/principles of the 20-week SfSL group therapy. Brief-SfSL incorporates the SfSL guiding principles of emphasizing safety, attending to the therapeutic relationship, recognizing the participant as the expert in their own experience, taking a trauma-informed approach, working with emotions while recognizing the role of alexithymia, and incorporating solution-focused concepts. The goal is to increase a person's understanding and capacity to engage in what would enable them to keep safe, even if thoughts of suicide are present. The intervention procedure is dynamic, but includes 4 core tasks: 1) understanding the individual's suicidal experience, 2) skills building, 3) developing a safety plan, and 4) identifying obstacles to enacting or engaging with the safety plan.
15794638|NCT04495530|Other|Non-interventional study|semi-structured interviews will take place on one occasion with participants in this study. This is qualitative research, and does not involve any interventions
15794639|NCT04495504|Drug|Ropivacaine|Administration of a bolus dose of 10 ml of ropivacaine 7, 5 mg/mL in each catheter Continuous infusion of ropivacaine 2 mg/ml in a rate of 3 mL/h during the first 48 hours postoperatively.
15794640|NCT04495491|Other|pupillary block group|According to the configurations of angle closure, the pupillary block group is defined as the iris bombe.
15794641|NCT04495491|Other|plateau iris group|According to the configurations of angle closure, the plateau iris group is defined as the thickness of the peripheral iris.
15794642|NCT04495491|Other|mixing mechanism group|According to the configurations of angle closure, the mixing mechanism group is defined as the iris bombe plus thickening of the peripheral iris.
15794643|NCT04495478|Drug|Ramucirumab - IV|Administered IV.
15794644|NCT04495478|Drug|Placebo - IV|Administered IV.
15794645|NCT04495478|Drug|Ramucirumab - SC|Administered SC.
15794646|NCT04495478|Drug|Placebo - SC|Administered SC.
15794647|NCT04495465|Other|Radial Shock Wave Therapy|2000 shots of extracorporeal radial shock waves therapy on neck muscles at 4bars and 10 Hertzs
15794648|NCT04495465|Other|Manual Therapy|25 minute massage to neck muscles
15794649|NCT04495465|Other|placebo shock waves|3 minutes of placebo extracorporeal radial shock waves therapy on painful points of neck muscles.
15794650|NCT04495452|Drug|Fentanyl Drug Administration|Subjects will be given a standardized dose of fentanyl 2.5 mcg/kg estimated ideal body weight (males: ideal body weight = 50 kg + 2.3 kg for each inch over 5 feet. Females: Ideal body weight = 45.5 kg + 2.3 kg for each inch over 5 feet).
15794651|NCT04495439|Device|Augmentation with the ISS Study System|Augmentation with the ISS Study System
15794652|NCT04495439|Other|Augmentation with PMMA|Augmentation with PMMA (standard)
15794653|NCT04495426|Other|Non-interventional study|There are no treatments to stop or even slow down the progression of this disease although there are treatments that temporarily improve the symptoms, such as anti-seizure medications.
15794654|NCT04495400|Procedure|Thoracolumbar Fracture Fixation|The is surgery is preformed on patients who have had a blunt trauma fractures between the T10 and the L2. The surgical management for more severe/unstable fractures usually involves posterior instrumentation with percutaneous or open pedicle screw fixation. While the traditional open pedicle screw fixation technique has demonstrated good radiologic and clinical outcomes, a minimally invasive percutaneous approach has been increasingly used in recent years.
15794655|NCT04495387|Drug|Chemotherapy|standard adjuvat chemotherapy for reast and colo cancer
15794656|NCT04495374|Drug|Pregabalin 300mg|Group P1 will receive a 300 mg tablet of pregabalin, 02h before the surgical procedure
15794657|NCT04495374|Other|Placebo|Group P0 will receive a placebo tablet, 02h before the surgical procedure
15794658|NCT04495361|Other|E-learning portal|An online learning portal for the identification and management of pneumonia in under five children
15794659|NCT04495348|Drug|Doravirine|Participants will be switched to doravirine and then switched back to INSTI-based therapy to determine the impact on energy balance.
15794660|NCT04495335|Device|photobiomodulation|Laser treatment will complete using Gallium-Aluminum-Arsenide (GaA1As) diode laser and application will complete by laser energy immediately and three times a week for just 15 days after surgery.
15794661|NCT04495322|Drug|TG-1000|Subjects will receive one single oral dose of TG-1000 on day 1 following protocol requirements.
15794662|NCT04495322|Drug|Placebo|Subjects will receive one single oral dose of placebo on day 1 following protocol requirements.
15794663|NCT04495309|Radiation|Metastases-directed Radiotherapy|Ablative radiotherapy (radiosurgery, stereotactic radiotherapy, hypofractionated image-guided radiotherapy (IGRT)) with few high-dose fractions
15794664|NCT04495296|Biological|TST001 injection|TST001 Injection with dose escalation stage of 0.3mg/kg up to 20mg/kg, as well as dose expansion stage with recommended dose level from dose escalation stage.
15794665|NCT04495283|Drug|Pregabalin|Pregabalin is a structural derivative of the inhibitory neurotransmitter gamma aminobutyric acid with anticonvulsant, anxiolytic and sleep-modulating properties.
15794666|NCT04495283|Drug|Acetaminophen|Acetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent.
15794667|NCT04495270|Diagnostic Test|"Analysis of treatment outcomes of teeth with apical periodontitis based on cone-beam computed tomography and estimated by means of Periapical and Endodontic Status Scale"|Patients were examined by cone-beam computed tomography at baseline and in 24 months after endodontic treatment. Treatment outcome was evaluated using estimates of periapical radiolucencies in size, relation with anatomical structures and location.
15794668|NCT04495257|Drug|Nivolumab|Nivolumab 3mg/kg intravenously (IV) every 3 weeks for the first 4 treatments and then will be given at 360mg every 3 weeks thereafter
15794669|NCT04495257|Drug|Ipilimumab|Ipilimumab 1mg/kg intravenously (IV) every 3 weeks for a total of 4 treatments
15794670|NCT04495257|Drug|APX005M|APX005M 0.3mg/kg intravenously (IV) every 3 weeks
15794671|NCT04495244|Diagnostic Test|Syantra DX Breast Cancer|Blood test for detecting the presence of breast cancer.
15794672|NCT04495218|Biological|Blood samples|Performed a 10 ml blood sample (2 unnamed samples of 5ml) in each of the 100 patients included.
15794673|NCT04495205|Biological|PRF under non-eugenol containing periodontal pack|Platelet Rich Fibrin under non-eugenol containing periodontal pack
15794674|NCT04495205|Other|Non-eugenol containing periodontal pack|Non-eugenol containing periodontal pack after gingival depigmentation
15794702|NCT04495010|Biological|Nivolumab|Specified dose on specified days
15794679|NCT04495166|Behavioral|Motherly 1.0|A mobile app designed to promote life habits that have been shown to improve physical and mental health in pregnant women. The app consists of a package of specific and customized interventions defined by eight different modules: 1) Mental Health; 2) Sleep; 3) Nutrition; 4) Physical activity; 5) Social support; 6) Prenatal support; 7) Postnatal support, and 8) Library of pre and postnatal content. The app relies on extensive psychoeducational content delivered as tutorials, brief messages, and available as a library that can be read at the users' discretion; behavior monitoring using schedules, checklists, and notifications to help participants keep track of their health care visits, and schedule behavior activation activities; and gaming elements such as changes in background appearance to reflect participant's mood assessment and ratings of activities, and graphical and easy-to-use questionnaires for obtaining information (mood, nutrition habits).
15794680|NCT04495166|Behavioral|Brief Psychotherapy|Brief Cognitive-Behavioral Therapy (CBT) with a focus on behavioral activation (BA). Participants will be guided by psychotherapists to plan, schedule, and engage in positively reinforcing activities, and will be aided to develop problem-solving strategies for circumventing barriers to completing scheduled activities. Implementation of these techniques will be conducted with the aid of the Motherly 1.0 for participants in the experimental arm; for participants in the control arm, BA will be implemented without the aid of Motherly 1.0. Throughout the four sessions, psychotherapists will monitor participants' adherence, answering questions about the strategies and providing support for solving problems or CBT techniques, such as cognitive restructuring, relaxation techniques, sleep hygiene, stress and anxiety management, among other evidence-based techniques might be used if appropriate to the case.
15794681|NCT04495166|Behavioral|Educational app|A simplified version of the Motherly 1.0 app consisting of psychoeducational content about various aspects of pregnancy, maternal physical and mental health, and child development. Active intervention functionalities, such as behavioral activation, activity scheduling, sleep hygiene, among others, are NOT present in this simplified version of the app.
15794683|NCT04495140|Drug|[14C]PF-06882961, 50 mg|A single oral dose of [14C]PF-06882961, will be administered as a liquid formulation.
15794684|NCT04495140|Drug|PF-06882961, 50 mg and [14C]PF-06882961, 100 ug|A single, oral, unlabeled dose of PF-06882961, 50 mg will be administered as a liquid formulation. Approximately 3 hours after the administration of the unlabeled oral dose, a single dose of [14C]PF-06882961 will be administered via intravenous infusion.
15794685|NCT04495127|Drug|Selumetinib|Selumetinib 25 mg/m2 BID
15794686|NCT04495114|Other|40g carbohydrate load (Apple juice)|A 40g carbohydrate drink will be administered to subjects with non-insulin dependent type 2 diabetes 3 hours prior to their operation. This is standard practice in subjects without diabetes.
15794687|NCT04495101|Biological|Prolastin|Intravenous infusion 120 mg/kg
15794688|NCT04495101|Drug|Standard Medical Treatment|Standard medical treatment per local policies or guidelines
15794689|NCT04495088|Drug|mFOLFOX (neoadjuvant)|neoadjuvant application Folinic acid: 400 mg/m2, 2h i.v., on day 1 Oxaliplatin: 85 mg/m2, 2-6h i.v., on day 1 5-FU: 2400 mg/m2, 46-48h i.v., on day 1. Cycles are repeated on day 15. A total of 6 cycles are administered.
15794690|NCT04495088|Drug|XELOX (neoadjuvant)|neoadjuvant application Capecitabine: 1,000 mg/m2 bid, po, on days 1-14 Oxaliplatin: 130 mg/m2, 2-6h i.v. day 1 Cycles are repeated on day 22. A total of 4 cycles are administered.
15794691|NCT04495088|Drug|mFOLFOX (adjuvant)|adjuvant application Folinic acid: 400 mg/m2, 2h i.v., on day 1 Oxaliplatin: 85 mg/m2, 2-6h i.v., on day 1 5-FU: 2400 mg/m2, 46-48h i.v., on day 1. Cycles are repeated on day 15. A total of 6 cycles are administered.
15794692|NCT04495088|Drug|XELOX (adjuvant)|adjuvant application Capecitabine: 1,000 mg/m2 bid, po, on days 1-14 Oxaliplatin: 130 mg/m2, 2-6h i.v. day 1 Cycles are repeated on day 22. A total of 4 cycles are administered.
15794693|NCT04495088|Drug|Capecitabine (adjuvant)|adjuvant application Capecitabine: 1,250 mg/m2 bid, po, on days 1-14 Cycles are repeated on day 22. A total of 8 cycles are administered.
15794694|NCT04495088|Drug|"infusional 5-FU/FA AIO regimen (adjuvant)"|adjuvant application Folinic acid 2h i.v. 500 mg/m² 5-FU 2,600mg/m² (24h infusion) Days 1, 8, 15, 22, 29, 36; cycle is repeated day 57 (representing one cycle); a total of 3 cycles should be administered.
15794695|NCT04495088|Drug|"infusional 5-FU/FA de Gramont (adjuvant)"|adjuvant application Folinic acid 2h i.v. 200 mg/m² days 1 and 2 5-FU 400mg/m² bolus followed by 600mg/m² 22h infusion days 1 and 2 The cycle is repeated day 15; a total of 12 cycles should be administered.
15794696|NCT04495075|Other|Visuomotor Therapy|"The use of visual feedback informing internal physiological processes, such as muscle activation, torque, and joint position, has been termed visuomotor therapy. Visuomotor therapy encompasses completion of sub-maximal motor control tasks accompanying real-time visual biofeedback."
15794697|NCT04495075|Other|Passive Motion|The knee is passively moved through a range of motion.
15794698|NCT04495049|Device|Alcon Vivity or Vivity Toric IOL|Patients who previously underwent cataract surgery with the Alcon Vivity or Vivity Toric IOL in both eyes.
15794699|NCT04495036|Other|data collection (21-items-patient descriptive survey)|"Dermatology patients are asked to complete a 21-items-survey while waiting for the doctor's consultation. Following variables will be addressed:
~Demographic data of telemedicine users and non-users
~Subjective disease perception of the dermatology patients
~Use of internet, telemedicine and telemedicine insurance model
~Patients´ willingness for additional features of telemedicine
~Advantages and disadvantages telemedicine and face-to-face consultation
~Suitable fields of dermatology for telemedicine from the patient's perspective
~Recommended structure of telemedical services by users and non-users"
15794700|NCT04495036|Other|data collection (23-items-physician descriptive survey)|"To obtain the view of Swiss dermatologists, other physicians and medical staff on telemedicine a 23-items-survey will be completed. Following variables will be addressed:
~Objective disease perception of the treating dermatologist (regarding the urgency of the patient's medical examination, the functional impairment and cosmetic burden due to patient's disease, the impairment of life quality due to patient's disease and the estimation of the course of the patient's disease)
~Suitable fields of dermatology for telemedicine from the physician's and medical staff's perspective"
15794701|NCT04495023|Procedure|Left elective colectomy|Open or laparoscopic left elective colectomy with colo-rectal anastomosis
15794704|NCT04494997|Other|Survey Questionnaire|"This Cross sectional study uses Questionnaire with Closed ended questions. The survey form is designed using Google forms program. Survey initial question seeks CONSENT from the respondent. Survey collects data under 4 sections.
~Section I: Demographic details Section II: 6 Questions regarding use of your Social Media for Professional activities.
~Section III: 7 Questions regarding the advantages of your Social Media use. Section IV: 5 Questions regarding the disadvantages of your Social Media use.
~The Google form questionnaire survey link will be shared with the Dentists in internet via Social Media &/Or email to seek responses. The link will be available for single response for a single respondent."
15794705|NCT04494984|Drug|INM005|The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
15794706|NCT04494984|Drug|Placebo|Placebo substance will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 48 h between doses.
15794707|NCT04494958|Drug|Combination, Palbociclib + Binimetinib|"Patients will then start treatment with continuous oral binimetinib 45 mg/BID and palbociclib 100 mg daily, 21 days on / 7 days off, until disease progression. Study treatment will continue until disease progression.
~If treatment tolerance is good, after a full cycle patients will be allowed to escalate palbociclib to 125 mg, according to the study investigators' decision. Alternatively, patients with non tolerable grade 2 events will resume at 30 mg/BID of binimetinib upon recovery, maintaining palbociclib at 100 mg 21-on/7-off. Depending on the side-effects, in case of clear relationship with palbociclib is established, palbociclib -instead of binimetinib - will be reduced to 75 mg daily."
15794708|NCT04494945|Procedure|Biospecimen Collection|Undergo collection of saliva sample
15794709|NCT04494945|Other|Genetic Counseling|Receive genetic counseling if testing results are positive
15794710|NCT04494945|Other|Genetic Testing|Undergo genetic testing
15794711|NCT04494945|Other|Survey Administration|Complete a survey
15794712|NCT04494932|Procedure|Self-Locking Tenotomy|Self-locking Tenotomy describes the surgical procedure that will be performed to treat SLAP tears.
15794713|NCT04494932|Procedure|Biceps Tenodesis|Biceps tenodesis describes the surgical procedure that will be performed to treat SLAP tears.
15794714|NCT04494919|Device|Ultrafine Endoscope|The reversal of the normal colonoscope (CV-260SL; Olympus, Tokyo, Japan) along the guidewire to replace the UFE (GIF-XP260NS; Olympus, Tokyo, Japan).
15794715|NCT04494906|Other|Interactive stepping exercise|An exercise intervention based on the principle of square stepping exercise
15794716|NCT04494906|Other|Square stepping exercise|Square stepping exercise
15794717|NCT04494880|Drug|Bupivacaine Injection|Treatment group receives Marcaine (Bupivacaine) injected into one breast following breast reduction surgery and a saline injection in the other group.
15794718|NCT04494867|Device|Core Warming|Esophageal heat transfer device will be set to 42°C temperature after initial placement, and maintained at 42°C for the duration of treatment.
15794719|NCT04494867|Other|Standard of Care|Standard temperature management and treatment
15794720|NCT04494841|Device|Duotherm VibraCool Back Device|Low back plate belt with mechanicothermal and pressure intervention options.
15794721|NCT04494828|Drug|Dexmedetomidine|Dexmedetomidine hydrochloride (200 μg/2 ml) is diluted with normal saline to 50 ml and is continuously intravenous infused at a rate of 0.025 ml/kg/hour (dexmedetomidine 0.1 μg/kg/hour). The intravenous infusion begins immediately after enrollment until 08:00 AM on the postoperative day one.
15794722|NCT04494828|Drug|Normal saline group|Normal saline is also diluted with normal saline to 50 ml and is continuously intravenous infused at a rate of 0.025 ml/kg/hour, which is the same with the dexmedetomidine group. The intravenous infusion begins immediately after enrollment until 08:00 AM on the postoperative day one.
15794723|NCT04494815|Drug|SR419|Each participant will receive 1 dose of 20 mg SR419 oral suspension.
15794724|NCT04494815|Drug|active control|Each participant will receive 1 dose of 300 mg active control capsule.
15794725|NCT04494815|Drug|SR419 placebo|Each participant will receive 2 doses of SR419 placebo oral suspension.
15794726|NCT04494815|Drug|active control placebo|Each participant will receive 2 doses of active control placebo capsule.
15794727|NCT04494802|Behavioral|lower pressure|During the operation, cuff pressure of LMA flexible is maintained to 30cmH2O
15794728|NCT04494802|Behavioral|higher pressure|During the operation, cuff pressure of LMA flexible is maintained to 50cmH2O
15794729|NCT04494789|Drug|Fludrocortisone Acetate|50mcg
15794730|NCT04494789|Drug|Fludrocortisone Acetate|100mcg
15794731|NCT04494789|Drug|Fludrocortisone Acetate|200mcg
15794732|NCT04494789|Other|Standard Therapy|NO Fludrocortisone
15794733|NCT04494763|Drug|Propanolol|Non-selective Beta-blocker
15794734|NCT04494763|Other|Placebo|Inactive drug
15794735|NCT04494737|Behavioral|Active Comparator: Program 1|A well-established behavioral method for reducing stress. To maintain blinding, details will be given to participants after randomization.
15794736|NCT04494737|Behavioral|Active Comparator: Program 2|A well-established behavioral method for reducing stress. To maintain blinding, details will be given to participants after randomization.
15794737|NCT04494724|Drug|Clazakizumab|Infusion
15794738|NCT04494724|Drug|Placebo|Infusion
15794739|NCT04494711|Behavioral|Physical Functional Literacy for Adults|A 5 week physical literacy for program focused on virtual knowledge translation strategies to improve function and mobility for adults with multiple chronic conditions. This is a population -based approach to rehabilitation
15794740|NCT04494698|Device|Duotherm VibraCool Back Device|Active New multimodal pain device
15794741|NCT04494698|Device|Posture Plate|sculpted low back plate in belt from new multimodal device, no active heat, pressure, cold, or vibration options.
15794742|NCT04494685|Device|Intervention group (Robotic rehabilitation)|Robotic rehabilitation with Erigo® equipment (Hocoma, Volketswil, Switzerland). The training protocol has a progression of the board inclination up to 90º associated with flexion/extension movements of the knees and hips, with time evolution of up to 40 minutes. Such equipment is associated with electrostimulation of the quadriceps, hamstrings, sural triceps and anterior tibialis.
15794777|NCT04494399|Drug|Interferon beta-1b|5-day course of daily subcutaneous injection of interferon β-1b 16 million IU
15794743|NCT04494685|Other|Control group (Conventional physiotherapy)|Knee and hip flexion and extension movements, hip adduction, and abduction, respecting the articular physiology of each joint. Weight transfer will also be performed in the sitting and standing position, mini squat, and gait training. All exercises will have a total of 10 repetitions in three sets. In the end, stretching of the upper and lower limbs will be performed.
15794744|NCT04494672|Procedure|Intramedullary nailing with ADAPT system|Stryker ADAPT®system (ADAPT, Stryker Leibinger GmbH & Co. KG, Freiburg, Germany) is a computer navigation system which can reconstruct a 3D model of the femoral head from the positional information oriented by bidirectional fluoroscopic views. ADAPT shows the distance from the tip of the screw to the surface of the femoral head, tip-to-head-surface distance (TSD), and tip-apex distance (TAD) intraoperatively
15794745|NCT04494672|Procedure|Intramedullary nailing without ADAPT system|Intramedullary nailing without ADAPT system
15794746|NCT04494659|Drug|Famitinib capsule|single dose and co-administrated with Rifampicin capsule
15794747|NCT04494659|Drug|Rifampicin capsule|repeated doses of Rifampicin capsule
15794748|NCT04494646|Drug|Bardoxolone Methyl|Once-daily administration of bardoxolone methyl (20mg)
15794749|NCT04494646|Drug|Placebo|Once-daily administration of matching placebo
15794750|NCT04494633|Other|Clinical Encounters Medical School VR Simulation|A VR based simulation related to coping with the stresses of medical school and burnout.
15794751|NCT04494620|Diagnostic Test|Visual Inspection of Oral Cavity for Precancers and Cancer|Participants were invited for 3 rounds of oral cavity cancer screening, conducted 3-years apart. Screening was conducted by health workers trained to perform visual inspection of the oral mucosa and identify potential precancerous lesions or oral cancer. Lesions found were referred to a weekly clinic for further evaluation by dentists and oncologists with experience in the diagnosis of oral lesions. Oral precancerous lesions were surgically excised whenever possible and those with confirmed oral cancer were referred for appropriate treatment with surgery, radiotherapy, and/or chemotherapy.
15794752|NCT04494607|Dietary Supplement|lowest Glycemic Index for a selected type fo cereal product|determination of lowest Glycemic Index for a selected type fo cereal product
15794753|NCT04494594|Behavioral|Drinks:Ration app|Drinks:Ration (www.drinksration.app; formerly called InDEx) app has been developed following the Medical Research Council Complex Intervention Guidelines and using co-design methodology by the King's Centre for Military Health Research (at King's College London) and the University of Liverpool, supported by experts in smartphone app development, epidemiology, addiction psychiatry, and military mental health. The app is designed to support veterans drinking at a hazardous or harmful level by providing detailed advice and support over a minimum of 28-day period. The app is theoretically underpinned to enhance participants motivation and self-efficacy in modifying their alcohol consumption by means of Behaviour Change Theory in the content displayed, and the messaging sent to participants.
15794754|NCT04494581|Other|questionnaire|Questionnaire survey
15794755|NCT04494568|Device|HIFU treatment|HIFU Treatment of rectal endometriosis
15794756|NCT04494555|Device|Static socket|For the static socket configuration, both the microprocessor control and user control are disabled, and the panels are positioned in their flush configuration to create the user's as-prescribed socket shape.
15794757|NCT04494555|Device|User adjusted socket|Sockets are configured for user control by disabling automated control and enabling push buttons on the side of the socket to adjust socket size. Each button push effects a socket size change of approximately 0.3% volume. An upper button effects a socket size increase, and a lower button a socket size decrease. The buttons are countersunk so reduce risk of accidental pushes, and they do not function unless the user is stationary. An additional button push will not be executed until motor motion from the prior push has been completed. If a button is continuously held then the motor will continue moving until the button is released. Limits are set on cable length to ensure that sockets sizes threatening to the user's residual limb (too tight) are avoided. The push buttons effect inner-loop control that operates completely within the mechanism, achieving high-resolution adjustment of cable length with minimal error.
15794758|NCT04494555|Device|Microprocessor-adjusting sockets|"A strategy for automatically controlling the size of the socket during walking to compensate for unknown changes in limb volume will be used. The controller is essentially a regulator that continuously measures socket fit, and adjusts the socket to maintain a prescribed reference set point. Because the fit is automatically sustained, the prosthesis user is unaware of its operation."
15794759|NCT04494542|Procedure|Sustained Low Efficiency Dialysis (SLED)|sustained low efficiency dialysis (SLED)
15794760|NCT04494542|Procedure|Continuous Renal Replacement Therapy|Continuous Renal Replacement Therapy
15794761|NCT04494529|Drug|12 mg betamethasone + placebo|"After the first intramuscular injection of 12 mg of betamethasone, participants randomized to the Placebo Comparator group will receive 1 intramuscular injection of placebo."
15794762|NCT04494529|Drug|24 mg betamethasone|"After the first intramuscular injection of 12 mg of betamethasone, participants randomized to the Active Comparator group will receive the standard 2nd intramuscular injection of 12 mg of betamethasone."
15794763|NCT04494503|Drug|APG-2575|APG-2575 orally once daily, every 28 days as a cycle.
15794764|NCT04494503|Drug|Rituximab|Rituximab 375mg/m2 ivgtt on C1D8 and 500mg/m2 ivgtt on C2-6D1.
15794765|NCT04494503|Drug|Ibrutinib|Ibrutinib 420mg orally once daily during C1D8-28 and following cycles.
15794766|NCT04494490|Behavioral|Clinical Practice Guidelines and Psychologically Informed Physical Therapy training/audit/feedback|The aim of the active training strategy is to improve the knowledge and skills of physical therapists with regard to evidence-based physical therapy with an emphasis on active treatments and PIPT for the treatment of patients with low back pain and to encourage increased adherence with CPGs. This Continuing Education (CE) training session will be offered to all therapists regardless of study participation. During the CE training session, focus will be placed on interventions that have been shown to be effective, such as interactive education and discussion, feedback, and reminders.
15794767|NCT04494477|Behavioral|The IN•clued program|The INclued program as previously described.
15794768|NCT04494464|Other|No intervention|
15794769|NCT04494451|Drug|Vit C|vitamin C (25 mg/kg or max. 1.5 gram every 6 hourly) for maximum 5 day
15794770|NCT04494451|Drug|Standard medical Treatment|iv antibiotics alone
15794771|NCT04494438|Drug|Rituximab|
15794772|NCT04494425|Drug|Trastuzumab deruxtecan|Trastuzumab deruxtecan by intravenous infusion
15794779|NCT04494386|Biological|Umbilical Cord Lining Stem Cells (ULSC)|IV infusion of allogeneic ULSC (100 million cells per dose) in sterile saline for injection
15794780|NCT04494386|Other|Placebo (carrier control)|IV infusion of carrier control consisting of sterile saline for injection
15794781|NCT04494373|Drug|HS-20090|A human IgG2 monoclonal antibody with affinity and specificity for human RANKL
15794782|NCT04494373|Drug|Xgeva®|A human IgG2 monoclonal antibody with affinity and specificity for human RANKL
15794784|NCT04494347|Procedure|MitraClip TMVR and Watchman LAAO|The MitraClip device is a percutaneous edge-to-edge repair device that is intended to approximate the anterior and posterior mitral valve leaflets in patients with severe symptomatic mitral regurgitation with suitable anatomy. Device versions/types: MitraClip NTr, MitraClip XTr. The WATCHMAN device is a self-expanding left atrial appendage occlusion (LAAO) device with a porous covering on the proximal face. Device sizes: 21 mm, 24 mm, 27 mm, 30 mm, 33 mm.
15794785|NCT04494334|Procedure|Bronchoscopy for Probable Idiopathic Pulmonary Fibrosis and Sarcoidosis|Blood samples and Nasosorption sampling
15794786|NCT04494321|Drug|Budesonide|Inhaled corticosteroid
15794787|NCT04494321|Drug|Formoterol|Long Acting Beta Agonist (LABA)
15794788|NCT04494308|Other|biomarker identification|flow cytometric analysis of eosinophils membrane molecules
15794789|NCT04494295|Device|Aurora Surgiscope System|MIS evacuation of hematoma using the Aurora Surgiscope System
15794790|NCT04494282|Procedure|Endoscopic retrograde pancreatography|Endoscopic cannulation of main pancreatic duct
15794791|NCT04494269|Drug|Tegoprazan 50mg|Oral administration once daily
15794792|NCT04494256|Drug|BIIB105|Administered as specified in the treatment arm.
15794793|NCT04494256|Drug|Placebo|Administered as specified in the treatment arm.
15794794|NCT04494243|Drug|AD-214 10/600mg|1 tablet administered before the breakfast during 7 days
15794795|NCT04494243|Drug|Rabeprazole 10mg|1 tablet administered before the breakfast during 7 days
15794796|NCT04494230|Behavioral|Motor Proficiency in School Age ADHD: Contribution of Different Comorbidities|to investigate whether motor skills, manual dexterity and visual perception differ in the presence of ADHD and comorbid psychiatric conditions in school-age boys by comparing them typical development children.
15794797|NCT04494204|Combination Product|Immunofree tablets and Reginmune capsule|2 Immunofree tablets thrice a day at an interval of 4-5 hours for 10 days and 1 Reginmune capsule twice a day for 10 days
15794798|NCT04494191|Drug|Flibanserin 100Mg Tab|One tablet contains 100 mg Flibanserin
15794799|NCT04494191|Drug|Flibanserin 100 MG [Addyi]|One tablet contains 100 mg Flibanserin
15794800|NCT04494178|Device|2.0g G-PUR®|Oral administration (Intervention period I)
15794801|NCT04494178|Device|2.0g G-PUR®|Oral administration (Intervention period II)
15794802|NCT04494178|Other|Placebo|Intervention period I
15794803|NCT04494178|Other|Placebo|Intervention period II
15794804|NCT04494165|Other|massage with frankincense and myyrh essential oil|In addition to the standard physical therapy session, 30 patients in aromatherapy group received a total of six sessions of lumbar massage for three weeks with frankincense and myrrh essential oils, two sessions per week (2nd and 5th days of each week), each lasting 15 minutes. During the massage, an average of 3ml mixture prepared by adding 2% frankincense oil and 2% myrrh essential oil to jojoba carrier oil was used as an oil mixture.
15794805|NCT04494165|Other|massage with carrier oil|In addition to the standard physical therapy session, 31 patients in placebo group received a total of six sessions of lumbar massage for three weeks with jojoba oil, two sessions per week (2nd and 5th days of each week), each lasting 15 minutes.
15794806|NCT04494152|Diagnostic Test|Transthoracic echocardiography|Standard Point-of-Care echocardiographic examination in the intensive care unit.
15794807|NCT04494139|Behavioral|Behavioral and Canteen intervention|Behavioral intervention: 16 weeks
15794808|NCT04494139|Other|Canteen|Canteen changes to introduce health foods
15794809|NCT04494126|Drug|Tranexamic acid|Drug: Tranexamic Acid Injectable Solution the drug will be given to patients intravenously at a dose of 10mg/kg pre-operatively after induction on general anesthesia before incision.
15794810|NCT04494126|Drug|Placebo|Other: Placebo (normal saline 0.9%) An equivalent amount of normal saline (0.9%) will be given to the patient pre-operatively after induction of general anesthesia. The amount of saline given will correspond to the same amount of fluid which would have been given had the patient been in the intervention group.
15794814|NCT04494100|Procedure|TRONC|injection of 3 to 7 mL of Ropivacaine 3.75 mg/ml per nerve (median and ulnar nerves) and infiltration of 2 ml of Ropivacaine 3.75 mg/ml laterally above the flexion fold of the wrist in order to block the branches of the lateral cutaneous nerve of the forearm, the terminal sensory branch of the musculocutaneous nerve.
15794815|NCT04494100|Procedure|WALANT|infiltration with 3 to 7 ml of 1% lidocaine (10 mg/ml) combined with 0.005 mg/ml epinephrine and 8.4% sodium bicarbonate in the subcutaneous area in front of the transverse ligament, between the thenar and hypothenar eminences, from the flexion fold of the wrist over a length of 5 cm.
15794816|NCT04494100|Procedure|Tourniquet|inflation pressure 75 to 100 mmHg above systolic blood pressure.
15794817|NCT04494100|Drug|Ropivacaine|troncular blocks with Ropivacaine 3.75 mg/ml
15794818|NCT04494100|Drug|Lidocaine + Epinephrine|WALANT technique with 1% lidocaine (10 mg/ml) combined with 0.005 mg/ml epinephrine
15794819|NCT04494087|Other|Explanatory video|Links to explanatory videos handed out to patients to be watched at home after standard informed consent giving
15794820|NCT04494087|Other|Informed consent form|Links to a digital version of the informed consent form already discussed during the process of informed consent giving.
15794821|NCT04494074|Other|External Cooling|External Cooling
15794822|NCT04494061|Procedure|blood collection|Blood samples will be collected as per protocol defined schedule. There is no investigation drug in this study.
15794977|NCT04492826|Procedure|Postoperative infections rate|Assess the postoperative infection rate after otolaryngology bone flap surgery.
15795460|NCT04488770|Drug|Placebo|Matching strength placebo capsules will be provided
15794823|NCT04494048|Other|Endoscopic Bariatric Therapies|Participation in this study will allow for data collection through medical chart review for at least 6 standard of care visits up to 1 year after consenting to participate in this registry study. The exposure of interest is total body weight loss, safety and efficacy
15794824|NCT04494035|Device|CAPERE Thrombectomy System|Arteriovenous graft thrombectomy
15794825|NCT04494022|Diagnostic Test|contrast enhanced ultrasound|Perflubutane enhanced ultrasound for evaluating hepatic tumor
15794826|NCT04494009|Drug|INCMGA00012|INCMGA00012 (also known as MGA012) is a humanized, hinge-stabilized IgG4 monoclonal antibody against human PD-1, which blocks the interaction of PD-1 with PD-L1 and PD-L2, interrupting PD-1 signaling, enhances antigen-induced interferon-γ release, and has a favorable preclinical profile.
15794827|NCT04493996|Behavioral|Cognitive training|The cognitive training involves a standardized, paper-and-pencil-based cognitive training that will be performed by the patients at home for approximately 40 minutes per day over a preoperative period of 2-3 weeks
15794828|NCT04493983|Procedure|laparoscopic salpingo-oophorectomy|Laparoscopic bilateral salpingo-oophorectomy
15794829|NCT04493983|Procedure|Laparoscopic bilateral salpingo-oophorectomy|Unilateral oophorectomy was performed immediately after abdominal entry, and the remaining contralateral ovary was excised at the end of the hysterectomy in order to compare the effect of these surgical procedures on ovarian tissue.
15794830|NCT04493970|Other|High School Students Survey|To assess retention, effectiveness and factors impacting comprehension of cardiopulmonary resuscitation (CPR) training among high school students.
15794831|NCT04493957|Behavioral|ACCOMPAGNE Education Program|"The following workshops will be organised :
~Presentation workshop
~Cognitive skills workshop
~Perception and Environment workshop
~Responsibilities workshop
~Representation workshop -
~Caregivers workshop,
~Solutions workshop"
15794832|NCT04493957|Behavioral|Usuals recommandations|Recommendations consist of a description of the cognitive and sensorimotor risk factors specific to the patient for driving and advice for the adaptation of driving or the recommendation of the stopping of driving. It is usually served by oral or written to the patient, with mention in the patient's file of the recommendation and issued in the presence of his close companion.
15794833|NCT04493944|Behavioral|Culinary workshop|A 3-hour culinary workshop will be led by a chef. The aim of this workshop will be to develop participants' culinary skills related to the preparation and consumption of recipes based on seaweeds, through various practical activities in the kitchen (starter, main course, dessert). An evaluation questionnaire will be completed at the end of the workshop.
15794834|NCT04493931|Drug|Gepotidacin|Gepotidacin tablets will be available as unit dose strength 750 mg and will be administered orally.
15794835|NCT04493931|Drug|Cimetidine|Cimetidine tablets will be available as unit dose strength 400 mg and will be administered orally.
15794836|NCT04493931|Drug|Rifampicin|Rifampicin Capsules will be available as unit dose strength 300 mg and will be administered orally.
15794837|NCT04493931|Drug|Midazolam|Midazolam oral syrup 2 milligrams per milliliter (mg/mL) will be available to be administered orally.
15794838|NCT04493931|Drug|Digoxin|Digoxin tablets will be available as unit dose strength 0.25 mg and will be administered orally.
15794839|NCT04493931|Other|Placebo matching to gepotidacin|Placebo matching to gepotidacin tablets will be administered orally.
15794840|NCT04493918|Combination Product|Mesenchymal Stem cell + Nacl 0.9%|Patient who undergo surgery, debridement, decompression and posterior stabilization injection with Nacl 0.9% 2 ml + MSC 30 million unit
15794841|NCT04493918|Combination Product|NaCl 0.9%|Patient who undergo surgery, debridement, decompression and posterior stabilization injection with Nacl 0.9% 2 ml
15794842|NCT04493892|Behavioral|Educational Intervention|Deliver an educational intervention on harmful chemical exposures, such as phthalates, found in hair care products, developed by the research team using empirical evidence with key informant feedback. The intervention will cover phthalates 1) Exposure through HCPs 2) Potential adverse health outcomes for the mother and child 3) Ways to reduce exposure
15794843|NCT04493879|Other|Bioptron Light Therapy (BLT)|BLT for 30 days 10 minutes every day. The treatment points displayed were: one point in the right jugal mucosa, one point in the left jugal mucosa, one point in the lower lip 's inner mucosa, analgesics, anti-inflammatory treatment, and antimicrobial treatment for any new mouth infections)
15794844|NCT04493866|Other|Messages to departmental employees to improve quality of consent form completion|All interventions directed to members of the plastic surgery department: Intervention 1: Poster illustration common mistakes on consent forms. Intervention 2: Group message explaining Quality Improvement Project to the department. Intervention 3: Email from Consultant lead in support of project. Intervention 4: Further group message illustrating gains and ongoing goals of the project.
15794845|NCT04493853|Drug|Capivasertib|400 mg (2 tablets) BD given on an intermittent weekly dosing schedule. Patients will be dosed on Days 1 to 4 in each week of a 28-day treatment cycle. Number of Cycles: until disease progression or unacceptable toxicity develops.
15794846|NCT04493853|Other|Placebo|matched to capivasertib appearance (2 tablets) BD given on an intermittent weekly dosing schedule. Patients will be dosed on Days 1 to 4 in each week of a 28-day treatment cycle. Number of Cycles: until disease progression or unacceptable toxicity develops.
15794847|NCT04493853|Drug|Abiraterone Acetate|Administered orally as tablets at a dosage of 1000 mg daily. Administered continuously until criteria for discontinuation are met.
15794848|NCT04493840|Drug|Shenfu Injection|80ml Shenfu Injection + 70ml 5% glucose injection, ivdrip, within 30 minutes before PCI and 1 to 5 days (once a day) after PCI (6 times in total). Drug titration time should be no less than 30 minutes.
15794849|NCT04493840|Drug|5% Glucose Injection|150 ml 5% glucose injection, ivdrip, within 30 minutes before PCI and 1 to 5 days (once a day) after PCI (6 times in total). Drug titration time should be no less than 30 minutes.
15794911|NCT04493333|Drug|Vaginal Dehydroepiandrosterone|This is a vaginally administered suppository steroid indicated for the treatment of moderate to severe dyspareunia, a frequent symptom of vulvovaginal atrophy due to menopause or genitourinary syndrome of menopause.
15794912|NCT04493333|Combination Product|Vaginal Polycarbophil Moisturizer|This is an FDA cleared, over-the-counter personal lubricant for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity and supplement the body's natural lubrication. It is non-sterile, water-based, non-irritating, non-greasy, non-staining vaginal gel delivered as a long-lasting moisturizer for vaginal dryness.
15794850|NCT04493788|Other|Blood test, ultrasound and egg retrieval|Blood tests will be performed to determine free testosterone levels, anti-mullerian hormone (AMH) and lipid profile including fasting plasma glucose and insulin. Women from both PCOS and control groups will be minimally stimulated with gonadotrophins and cumulus-oocytes complexes (COCs) will be aspirated from small antral follicles (2-8mm) without any ovulation triggering. Specifically, administration of highly purified human menopausal gonadotropin (HP-hMG) will start on cycle Day 3 of the menstrual period or a withdrawal bleeding. A pelvic ultrasound scan will be performed in the morning of the last stimulation day to schedule the oocyte collection. Cumulus-oocyte complexes retrieved 42 hours after the last gonadotropin injection will be collected, washed, denuded and individually stored for further molecular characterization.
15794851|NCT04493775|Device|Brainwave Entrainment|Alpha frequency visual and auditory stimulation delivered through a smartphone application, with the use of a virtual reality headset and earphones respectively.
15794852|NCT04493749|Diagnostic Test|ECG measurement|Simultaneous recording of a single-lead ECG signal with the Withings Move ECG and ECG signal for the reference 12-lead ECG
15794853|NCT04493736|Behavioral|MHSAFE app recording|Participants are asked a series of questions to elicit their feelings and emotions as part of an audio recorded interview along with their normal therapy session.
15794854|NCT04493723|Procedure|Surgery|To collect tumour tissue
15794855|NCT04493723|Procedure|Venepuncture|To collect blood samples
15794856|NCT04493710|Diagnostic Test|Sarcopenia estimation|Analysis of pre-existing CT imaging
15794857|NCT04493697|Device|Experimental 1|A ThermoNeuroModulation device will be worn by the participant that delivers warm waveforms in one ear (42 °C) and cool waveforms (17 °C) in the other ear.
15794858|NCT04493697|Device|Experimental 2|A ThermoNeuroModulation device will be worn by the participant that will neither warm nor cool.
15794859|NCT04493684|Drug|GSK3739937 (PIB)|GSK3739937 will be administered as oral suspension.
15794860|NCT04493684|Drug|Placebo|Placebo will be given orally during each dosing day.
15794861|NCT04493684|Drug|GSK3739937 (Tablet)|GSK3739937 Tablet will be administered via oral route.
15794862|NCT04493671|Drug|TBAJ-876 10mg|TBAJ-876 10mg tablets, oral suspension, orally administered
15794863|NCT04493671|Drug|TBAJ-876 25mg|TBAJ-876 25mg tablets,oral suspension, orally administered
15794864|NCT04493671|Drug|TBAJ-876 50mg|TBAJ-876 50mg tablets,oral suspension, orally administered
15794865|NCT04493671|Drug|TBAJ-876 100mg|TBAJ-876 100mg tablets, oral suspension, orally administered
15794866|NCT04493671|Drug|TBAJ-876 200mg|TBAJ-876 200mg tablets, oral suspension, orally administered
15794867|NCT04493671|Drug|TBAJ-876 400mg|TBAJ-876 400mg tablets, oral suspension, orally administered
15794868|NCT04493671|Drug|TBAJ-876 Dose XXXmg for Food cohort|Based on exposure levels from initial cohorts, a dose will be chosen for the food-effect cohort.
15794869|NCT04493671|Drug|TBAJ-876 XXXmg for Part 2|Part 2, Multiple ascending dose (MAD) cohorts doses to be determined.
15794870|NCT04493671|Drug|Matching Placebo for TBAJ-876 tablet|Matching Placebo for TBAJ-876 tablets, oral suspension, orally administered
15794871|NCT04493658|Diagnostic Test|Questionnaires|Cognitive ability questionnaires, dry eye symptom questionnaires (Ocular Surface Disease Index, Impact of Dry Eye in Everyday Life, Visual Function Questionnaire-25, Eye Dryness Visual Analog Scale, Visual Fatigue Visual Analog Scale, Visual Tasking Questionnaire, Short Form Survey-36, Profile of Fatigue and Discomfort, European League Against Rheumatism Sjögren's Syndrome Patient Reported Index) will be completed by the subjects
15794872|NCT04493658|Diagnostic Test|Tear fluid sampling|Using microcapillary tubes, 1 microliter of tear fluid will be collected in both eyes of each subject.
15794873|NCT04493658|Diagnostic Test|Impression Cytology|Under topical anesthesia, impression cytology sampling will be performed in the temporal bulbar conjunctiva of both eyes of each subject.
15794876|NCT04493619|Drug|PLX2853|PLX2853 tablets
15794877|NCT04493619|Drug|Carboplatin|Carboplatin IV injection, 5 mg•min/mL
15794878|NCT04493606|Other|SCI ProACTIVE Coaching (objective 1)|Peer coaches will conduct an assessment to understand patient's readiness, goals, barriers, preferences, and access to physical activity resources and mutually select tailored physical activity-enhancing strategies based on the assessment. These strategies include education (SCI exercise guidelines, safety, benefits, basics of physical activity, behaviour change techniques) and referral to appropriate peers, programs, and organizations. Goals will be based on the SCI Fitness Guidelines (targeting a goal of 20min of moderate to vigorous intensity aerobic exercise + 3 sets of strength training exercises for each major functioning muscle group at a moderate to vigorous intensity each 2x/week) and if ready, the Canadian SCI Physical Activity Guidelines (30 min 3x/week of moderate to vigorous intensity aerobic exercise + strength training 2x/ week). Ten 15-minute, video-conference or telephone sessions will be scheduled in accordance with patient needs and readiness with the peer coaches.
15794879|NCT04493606|Behavioral|Implementation Intervention (objective 2)|"A training on how to deliver the ProACTIVE intervention will be delivered. Day 1 training will include an overview of the intervention, demonstration of the delivery of the intervention, and behavioural practice. Interventionists will practice delivering the intervention and record issues or questions to bring to the day 2 training. Day 2 training will include a refresher on intervention content, barriers identified during in-clinic/community practice will be addressed, and further behavioural practice with volunteer clients with additional feedback provided.
~The trainer (Dr. Jasmin Ma) will provide monitoring and feedback during the first two months of implementation. Community of practice meetings will be held as needed to discuss challenges and facilitators to implementation. Feedback provided during community of practice meetings will be collected and used for iterative quality improvement of the intervention approaches."
15794913|NCT04493320|Drug|Carbidopa/levodopa|150-450mg carbidopa/levodopa 3 times daily
15794914|NCT04493320|Drug|Placebo|Carbidopa/levodopa-matched placebo tablet 3 times daily
15794880|NCT04493593|Behavioral|SilverCloud|"'Space for Sleep' is a seven-module online CBT-based intervention for sleep. The structure and content of the programme modules follow evidence-based CBT principles for insomnia. Each module is structured to incorporate introductory quizzes. videos, informational content, interactive activities, as well as homework suggestions and summaries. In addition, personal stories and accounts from other users are incorporated into the presentation of the material.
~As per normal service provision, each participant will be assigned a clinician (PWP) who will monitor participants' progress through the program. Every one to two weeks, the PWP will login and review participants' progress, leaving feedback for them and responding to the work they have completed."
15794881|NCT04493580|Behavioral|iDBT|Electronic DBT sessions designed to mirror in-person DBT.
15794882|NCT04493580|Behavioral|In-Person DBT|In-person DBT
15794883|NCT04493567|Drug|BMS-986036|Specified dose on specified days
15794884|NCT04493554|Drug|Vasopressin|Administration of vasopressin (20 IU) intranasally
15794885|NCT04493554|Drug|Placebo|Administration of placebo intranasally
15794886|NCT04493541|Drug|BMS-986256|Specified Dose on Specified Days
15794887|NCT04493541|Other|BMS-986256 Placebo|Specified Dose on Specified Days
15794888|NCT04493528|Combination Product|Meso-Jet, 2% lidocaine(xylocaine)|Performing local dental anesthesia using needle-free liquid jet injection with different parameters (pressure, volume, injection technique). Anesthetic agent: 2% lidocaine with 1:100,000 epinephrine, dose: 0.3-2ml.
15794889|NCT04493528|Combination Product|Needle,2% lidocaine(xylocaine)|Performing local dental anesthesia using syringe and needles, same as regular clinical practice. Anesthestic agent: 2% lidocaine with 1:100,000 epinephrine,dose: 0.3-2ml.
15794890|NCT04493515|Drug|Oral Oxytocin|Administration of oxytocin orally (24 IU)
15794891|NCT04493515|Drug|Oral Placebo|Administration of placebo orally (24 IU)
15794894|NCT04493489|Drug|Propranolol Hydrochloride|Trial group: BCG + propranolol: after TURBT administered for 2 consecutive years, oral propranolol, starting dose 10mg, tid, then 20mg, tid,lastly increased to 40mg, bid. After the last BCG infusion, propranolol was gradually reduced, in the order of 20 mg, tid to 10 mg, tid.
15794895|NCT04493489|Drug|BCG|Control group: BCG vaccine: After TURBT, the first year: once a week for 6 times, from the 7th week, once every 2 weeks, and 3 times. Administer once a month starting from the 13th week and continue to give 10 times. Second and third years: once a month, 12 times a year.
15794896|NCT04493476|Drug|Chinese herbal formula|Chinese herbal formula
15794897|NCT04493463|Drug|Methylprednisolone 40 mg + Ropivacaine + Saline|To infiltrate the study solution, the surgeon will inject the incision site with a 10 cm long, 22-gauge needle before the closing of the incision site. A standard volume of 10 ml in each level will be injected, based on the study by Milligan et al., with a total of 5ml study solution injected laterally into the erector spinae muscle and 5 ml subcutaneously along both margins of the incision. This standardization will be on the basis of the number of levels to be treated, and will be consistent in each patient. The depth of penetration will include the subcutaneous tissues, paravertebral muscles, along with the deep muscles surrounding the spinous process, lamina, transverse process and facet joints; the epidural space and intrathecal space will be spared. The local infiltration solution in the treatment group will consist of a total of 30 ml study solution, containing 1 ml of 40 mg methylprednisolone plus 15ml of 1% ropivacaine and 14 ml saline.
15794898|NCT04493463|Drug|Ropivacaine + Saline|To infiltrate the study solution, the surgeon will inject the incision site with a 10 cm long, 22-gauge needle before the closing of the incision site. A standard volume of 10 ml in each level will be injected, based on the study by Milligan et al., with a total of 5ml study solution injected laterally into the erector spinae muscle and 5 ml subcutaneously along both margins of the incision. This standardization will be on the basis of the number of levels to be treated, and will be consistent in each patient. The depth of penetration will include the subcutaneous tissues, paravertebral muscles, along with the deep muscles surrounding the spinous process, lamina, transverse process and facet joints; the epidural space and intrathecal space will be spared. The local infiltration solution in the control group will consist of a total of 30 ml study solution, containing 15 ml of 1% ropivacaine and 15ml saline.
15794899|NCT04493450|Other|Documentation of cancer treatment side effects|Standardized documentation of occurred side effects
15794900|NCT04493437|Device|Telerehabilitation|Blood pressure (iHealth Neo), weight (iHealth Lina), step counters(Fitbit Inspire & Charge 3), sleep sensor (Emfit QS), tablet (iPad Air 2), and ECG recorder (AliveCor KardiaMobile).
15794902|NCT04493411|Procedure|WBMRI|"WBMRI will be performed at 4 timepoints during the study.
~Baseline: (before induction therapy)
~Between Week 12 - 24 (before Bone Marrow Transplant)
~Between Week 24 - 36 (before starting maintenance therapy)
~Between Week 60 - 72 (post bone marrow transplant and after approximately 9 months of maintenance therapy)"
15794903|NCT04493411|Procedure|Positron Emission Tomography/Computed Tomography (PET/CT)|"PET/CT will be performed at 4 timepoints during the study.
~Baseline: (before induction therapy)
~Between Week 12 - 24 (before Bone Marrow Transplant)
~Between Week 24 - 36 (before starting maintenance therapy)
~Between Week 60 - 72 (post bone marrow transplant and after approximately 9 months of maintenance therapy)"
15794904|NCT04493398|Procedure|Gracey curette.|Root planed was performed with curettes (Gracey SAS, Hu-Friedy, Chicago, IL, USA).
15794905|NCT04493398|Procedure|Ultrasonic scaler.|Debridement was performed with an ultrasonic scaler (Piezon Master 400 Perio Slim Tip®; Electro Medical System, Nyon, Switzerland).
15794906|NCT04493398|Procedure|Erythritol air-polishing.|Treatment was performed with a low abrasive erythritol powder (Air-flow powder plus®, EMS, Nyon, Switzerland ) applied through a Perio-Flow hand piece connected to an airflow unit (Air-Flow Master®, EMS, Nyon, Switzerland).
15794907|NCT04493372|Diagnostic Test|Tests of sympathetic inhibition|Bolus phenylephrine infusion using the Oxford technique will generate the need to inhibit sympathetic activity. Similarly, resting state Mayer waves will be assessed with regard to heart rate and blood pressure responses.
15794908|NCT04493372|Diagnostic Test|Tests of sympathetic activation|Cold pressor test of the hand will be used to cause sympathetic activation. Valsalva's maneuver will assess the ability to buffer against blood pressure fall (phase II).
15794909|NCT04493372|Diagnostic Test|Testing of autonomic dysreflexia|Cold pressor test of the foot and bladder pressor response (in individuals with SCI) will be tested.
15794916|NCT04493294|Radiation|Low dose whole lung radiotherapy for older patients with COVID-19 pneumonitis|Low dose whole lung radiotherapy may decrease the cytokines storm related to the viral infection and may improve survival by decreasing the need for artificial ventilation
15794917|NCT04493281|Drug|MT-1186|Oral suspension
15794918|NCT04493281|Drug|MCI-186|Intravenous formulation
15794919|NCT04493255|Drug|[14C]E7090|[14C]E7090, oral capsule.
15794920|NCT04493242|Biological|DB-001|Intravenous administration of bone marrow mesenchymal stem cell derived extracellular vesicles
15794921|NCT04493242|Other|Intravenous normal saline|Placebo
15794922|NCT04493229|Drug|Oxytocin|IM Oxytocin
15794923|NCT04493229|Drug|Placebo|Placebo IM
15794924|NCT04493216|Drug|GSK3640254|GSK3640254 will be available as a 25 mg and 100 mg tablets to be administered via oral route.
15794925|NCT04493216|Drug|ABC/3TC|ABC/3TC will be available as abacavir 600 mg/lamivudine 300 mg tablet to be administered via oral route.
15794926|NCT04493216|Drug|FTC/TAF|FTC/TAF will be available as emtricitabine 200 mg/tenofovir alafenamide 25 mg tablet to be administered via oral route.
15794927|NCT04493216|Drug|Dolutegravir|Dolutegravir will be available as a 50 mg tablet to be administered via oral route.
15794928|NCT04493216|Drug|Placebo|Placebo matching GSK3640254 will be administered in the form of tablets via oral route.
15794929|NCT04493203|Drug|Nivolumab|Nivolumab is a human IgG4 monoclonal antibody that blocks PD-1. It is a type of Immunotherapy and works as a checkpoint inhibitor, blocking a signal that prevents activation of T cells from attacking the cancer.
15794930|NCT04493203|Drug|Axitinib|Axitinib (AG013736; trade name Inlyta) is a small molecule tyrosine kinase inhibitor.Its primary mechanism of action is thought to be vascular endothelial growth factor receptor 1-3, c-KIT and PDGFR inhibition, this, in turn, enables it to inhibit angiogenesis (the formation of new blood vessels by tumours)
15794933|NCT04493177|Behavioral|Educational intervention|Monthly 45-minute sessions will be held, including dietary, and physical activity modification, early stimulation, exclusive breastfeeding for 6 months and the proper introduction of foods, and other support for the mother. The sessions will be supported by personalized contact by WhatsApp and programmed telephone calls, in addition to conventional treatment.
15794934|NCT04493177|Other|Conventional treatment Guia de Practica Clinica IMSS-029-08|Conventional treatment includes some early stimulation, monthly visits for height/weight measurement of the offspring.
15794935|NCT04493164|Drug|Ivosidenib|Given PO
15794936|NCT04493164|Drug|Liposome-encapsulated Daunorubicin-Cytarabine|Given IV
15794937|NCT04493151|Drug|Imipenem, Cilastatin and Relebactam|After receipt of imipenem-cilastatin-relebactam, ten blood samples will be collected to determine the pharmacokinetics of imipenem and relebactam.
15794938|NCT04493138|Drug|Azacitidine|Given SC or IV
15794939|NCT04493138|Drug|Quizartinib|Given PO
15794940|NCT04493125|Drug|Mosapride citrate|Patients receive mosapride citrate (5mg/T) three times a day from the first day after surgery.
15794941|NCT04493125|Drug|Placebo|Placebo
15794942|NCT04493099|Drug|Alvocidib Hydrochloride|Given IV
15794943|NCT04493099|Drug|Decitabine|Given IV
15794944|NCT04493099|Drug|Venetoclax|Given PO
15794945|NCT04493086|Diagnostic Test|FFRCT-angio|According to invasive coronary angiography (CAG) images, image databases of critical lesions, diffuse lesions, left main trunk lesions, ostium lesions and bifurcation lesions were established. In order to ensure that the position of the pressure guide wire sensor is consistent with that of FFRCT-angio, a professional with unknown FFR results is used to mark the position of the pressure wire sensor on the CAG image. The clinical information and characteristics of coronary artery lesions were collected, and the baseline data of patients were completed. The accuracy and diagnostic performance of FFRCT-angio in the diagnosis of functional stenosis (FFR < 0.8) were evaluated with FFR value measured by pressure guide wire as reference standard.
15794946|NCT04493073|Procedure|Trabectulectomy|decrease IOP
15794947|NCT04493073|Drug|Mitomycin|Decrease bleb failure
15794948|NCT04493073|Device|Ologen Collagen Implant|Ologen Collagen Implant (Aeon Astron Europe, Netherlands)
15794949|NCT04493073|Device|Mitomycin-C Kyowa®|Mitomycin-C Kyowa® (Biochem Pharmaceutical Industries, India)
15794950|NCT04493060|Biological|Dostarlimab|Given IV
15794951|NCT04493060|Drug|Niraparib|Given PO
15794952|NCT04493047|Behavioral|Mobile health (mHealth) for pneumonia|Audiovisual mobile based application will be used to counsel caregivers of children under five on pneumonia and its prevention. This will be coupled with text and voice message dissemination to the cell phones of caregivers.
15794953|NCT04493034|Behavioral|Art Therapy|"The art therapist will assist each participant in producing a bound collection of participant art works/writings for personal, group and/or caregiver inspiration, at the participant's request. For in-person sessions, a variety of studio-based art and writing materials will be available for participant selection and creation. Each session will be directed in the following manner:
~New therapeutic prompt or bridge from prior session
~Creative expression, opportunity for reflection, verbal sharing / processing, and a session summary
~Discussion of action plan for the next consecutive, at-home session (weekly assignment).
~Possible wellness themes for each session (in-person or at-home) may include: mental health, physical health, emotional health, spiritual health, relational health (family and social), or occupational health/financial health."
15794978|NCT04492813|Drug|Pharmacokinetic of propofol and remifentanil|Pharmacokinetic of propofol and remifentanil in both population: Obese and non Obese patients
15795157|NCT04491266|Dietary Supplement|FBA|N-(1-carbamoyl-2-phenyl-ethyl) butyramide (FBA) has been developed.
15795158|NCT04491266|Dietary Supplement|placebo|maltodextrins
15794954|NCT04493034|Behavioral|Music Therapy|"Participants have the opportunity to engage in: learning an instrument, active music-making, receptive music-listening, singing, improvisation, song-writing, education on music technology, or music discussion. During in-person musical sessions the six psychosocial goals promoted by the music therapist include: 1) self-care/self-love, 2) support systems, 3) practicing positivity 4) gratitude 5) mindfulness/living in the moment, and 6) goal-setting.
~For at-home assignments, participants will be asked to pick a song of the week that coincides with the theme/goal discussed in previous session(s). They will be asked to write a journal entry about the topic discussed. Journal entries can be freely written or a prompt/question can be provided. If participants do not have access to search for songs or listen to music as at home, they may select a piece from the session and be given lyrics and/or a recording on an .mp3 player returned at conclusion of study."
15794955|NCT04493021|Device|Dermal Cooling System|Controlled localized cooling will be applied to benign pigmented lesions using the Dermal Cooling System
15794956|NCT04493008|Behavioral|Experimental: Educational session|Each patient will receive educational session consisting of face-to-face interview, administration of posters, brochures and pamphlets.
15794957|NCT04492995|Diagnostic Test|injection via TUMIR of the tracer [99mTc] Tc-albumin nanocoloid-ICG (6 mCi, 4 ml)|"The day before the surgery, a new scan (planar and SPECT / CT) will be performed after the injection via TUMIR of the tracer [99mTc] Tc-albumin nanocoloid-ICG (6 mCi, 4 ml) or the injection via TUMIR of [99mTc] Tc-albumin nanocoloid (6mCi, 8ml).
~The two lymphatic maps will be compared and the number of sentinel nodes identified in each study and the territories of drainage and the difference between them (in number and territories) will be established.
~On the day of surgery, a cervical injection of methylene blue will be performed at the start of surgery according to usual methodology (2 ml diluted to 50%). Intraoperative detection of the sentinel nodes will take place by visual inspection, using the gammadetector probe and NIR optics. Sentinel node biopsies will be processed according to the usual processing methodology and analysis for the detection of metastases."
15794958|NCT04492995|Diagnostic Test|injection via TUMIR of [99mTc] Tc-albumin nanocoloid (6mCi, 8ml).|"The day before the surgery, a new scan (planar and SPECT / CT) will be performed after the injection via TUMIR of the tracer [99mTc] Tc-albumin nanocoloid-ICG (6 mCi, 4 ml) or the injection via TUMIR of [99mTc] Tc-albumin nanocoloid (6mCi, 8ml).
~The two lymphatic maps will be compared and the number of sentinel nodes identified in each study and the territories of drainage and the difference between them (in number and territories) will be established.
~On the day of surgery, a cervical injection of methylene blue will be performed at the start of surgery according to usual methodology (2 ml diluted to 50%). Intraoperative detection of the sentinel nodes will take place by visual inspection, using the gammadetector probe and NIR optics. Sentinel node biopsies will be processed according to the usual processing methodology and analysis for the detection of metastases."
15794959|NCT04492982|Behavioral|Yoga|1 hour of group format, guided yoga practice
15794960|NCT04492982|Behavioral|Distress Tolerance|1 hour didactic group format, to develop distress tolerance skills
15794961|NCT04492956|Drug|Ecopipam|Oral tablet
15794962|NCT04492956|Drug|Placebo|Oral tablet
15794963|NCT04492930|Behavioral|14:10 Regimen|14 hours of fasting, followed by a 10-h diet regimen that includes a fasting snack at 12 hours from the start of the fasting period
15794964|NCT04492930|Behavioral|12:12 Regimen|12 hours of fasting, followed by a 12-h diet regimen
15794965|NCT04492917|Other|CV4|The osteopath was sitting at the head of the examination table, with the subject lying supine. The osteopath approximated with the hands the lateral angles of the occipital squama, taking the cranium into sustained extension. The technique ended when the osteopath perceived the still point, a condition in which the balanced membranous or ligamentous tension is achieved.
15794966|NCT04492917|Other|ST|The subject was lying in supine position, while the osteopath positioned the index and middle fingers of the caudal hand on either side of the subject's sacrum. Then establishes a point of balance between the coccyx and the vertex facilitating the sacral extension until the achievement of the still point
15794967|NCT04492917|Other|Sham CV4|sham intervention was performed placing the hands in the same position of the corresponding active technique, applying a light touch
15794968|NCT04492917|Other|Sham ST|sham intervention was performed placing the hands in the same position of the corresponding active technique, applying a light touch
15794969|NCT04492904|Other|Home-use Test and Follow-up Questionnaire|Prospective tracking of changes in taste and smell acuity, and related changes in appetite, enjoyment of food and food-related quality of life will be assessed using the Home-use Tests and Follow-up questionnaire over a period of 28 days.
15794972|NCT04492878|Drug|IKERVIS®1mg/mL|One drop of study medication once daily in each eye at bedtime during 90 days.
15794973|NCT04492865|Device|MSCT|"-Laboratory tests: All routine indicators of CBC are evaluated
~Nasopharyngeal and oropharyngeal swabs are obtained from each patient to confirm the positivity to Covid-19 by performing RT-PCR to detect the viral RNA.
~MSCT Chest images of all patients are evaluated by three radiologists with variable experiences in CT chest interpretation. The readers are blinded of the RT-PCR results and the CBC indices of the patients and they have access only to the epidemiological history, clinical symptoms, and signs. By consensus, the radiologists score the chest CT as positive or negative for COVID-19 viral pneumonia. When the chest CT is classified as positive, the main CT features are recorded as present or absent (ground-glass opacity, crazy paving, consolidation, nodules, air bronchogram, air trapping, halo sign, reversed halo sign, bronchial wall abnormalities, vascular enlargement, pleural effusion, and lymphadenopathy."
15794974|NCT04492852|Procedure|Polypropylene (PROLENE) sutures|After total knee replacement, the skin closure of the patients in this group will be done using polypropylene (PROLENE) sutures.
15794975|NCT04492852|Procedure|Staple Sutures|After total knee replacement, the skin closure of the patients in this group will be done using staple sutures.
15794976|NCT04492839|Device|Intestinal adsorbent|Participants will consume the 15ml of the intestinal adsorbent (3.5 g Silicon dioxide in 100 ml Silicic acid gel, Preservatives: Sorbic acid (E 200), Sodium benzoate (E 211). ) three times daily for 10 days. There are no known side effects of the medical device. The product is a class IIa medical device under the European council directive and the product will be used within it's current indications.
15795650|NCT04487106|Drug|Azacitidine|Given IV or SC
15794979|NCT04492800|Device|Paxman Scalp Cooling Device|Cooling will consist of precooling (30 minutes); infusion cooling (will vary depending upon the length of time to infuse the chemotherapy) and post infusion cooling (90 minutes).
15794980|NCT04492787|Drug|Changkang Granule|Take Changkang granule before meals twice a day , one bag for each time
15794981|NCT04492787|Drug|Changkang Placebo Granule|Take Changkang Placebo granule before meals twice a day , one bag for each time
15794982|NCT04492774|Combination Product|Goldic serum|epidural injections
15794983|NCT04492774|Drug|Steroid injections|epidural injections
15794984|NCT04492774|Procedure|Manual therapy|Veno-lymphatic drainage
15794985|NCT04492761|Behavioral|qualitative study|The qualitative approach will be based on content analysis of - Isemi-structured nterviews of families
15794986|NCT04492748|Combination Product|Collagen and platelet rich plasma (PRP)|Ultrasound guided injections
15794987|NCT04492748|Combination Product|Collagen|Ultrasound guided injections
15794988|NCT04492748|Combination Product|Platelet rich plasma (PRP)|Ultrasound guided injections
15794992|NCT04492709|Drug|Midazolam|The subjects will receive single doses of midazolam solution 2 mg/mL orally on Day 1 alone in Treatment Period 1 and on Day 7 co-administered with oral AZD5718 tablet in Treatment Period 3.
15794993|NCT04492709|Drug|AZD5718|The subjects will receive oral AZD5718 tablet once daily starting on Day 2 to Day 6 in Treatment Period 2 and on Day 7 co-administered with midazolam in Treatment Period 3.
15794994|NCT04492696|Other|Education|Education
15794995|NCT04492683|Combination Product|DBV1605|"Ready-to-use atopy patch test for diagnostic use containing 2 distinct patches:
~One active patch containing a dry deposit of 180 μg of cow's milk proteins
~One control patch with the same design as the active patch but devoid of any formulation."
15794996|NCT04492670|Procedure|Tui-na|For administering of Tui-na manipulation practice, responsible Tui-na CMP must have at least 2 years of clinical experience. The pre-trial workshops led by a senior practitioner will be organized to ensure standardization of Tui-na treatment manipulation and procedures.
15794997|NCT04492670|Drug|Du-Huo-Ji-Sheng-Tang (DHJST)|This study medication is derived from Du-Huo-Ji-Sheng-Tang (DHJST) and concentrated Chinese Medicine granules will be used.
15794998|NCT04492657|Other|no intervention|Natural exposure of iodine.
15794999|NCT04492644|Other|No intervention|No intervention
15795000|NCT04492631|Dietary Supplement|Streptococcus salivarius DB-B5|Sachets containing Streptococcus salivarius DB-B5 will be dissolved in water and consumed by the participants (n=30) once daily for 4 weeks. The participants will consume 10 billion colony forming units (CFU) per day.
15795001|NCT04492631|Other|Placebo|Sachets containing a placebo (probiotic carrier) will be dissolved in water and consumed by the participants (n=30) once daily for 4 weeks.
15795002|NCT04492618|Drug|Ruxolitinib|Ruxolitinib cream 1.5%, topical application will be used twice daily on lesions of Necrobiosis Lipoidica
15795006|NCT04492592|Behavioral|Workshop|Workshop
15795007|NCT04492592|Behavioral|SMS/Texting|SMS/Texting
15795008|NCT04492579|Other|Gentle-UHT donor human milk supplementation|Providers referred mothers with newborns that fit the following criteria: exhibited insufficient milk supply, an infant with early weight loss born >36 weeks gestation. Mother was given Gentle-UHT donor milk for supplementation, in addition to mother's own milk for the first week of the infant's life after hospital discharge.
15795009|NCT04492566|Device|Automated Insulin Delivery|"Participants will use the Automated Insulin Delivery (AID) iAPS system for 48-60 hours in a medically supervised session.
~For subjects who wish to continue use of the system, they will be offered the option of continuing use of the system at home in an extension phase, for the rest of their pregnancy."
15795010|NCT04492553|Drug|AndroGel|Treatment indication: hypogonadism after cancer treatment. Dosage: 1-2 sachets a day. Follows standard treatment.
15795011|NCT04492540|Other|aerobic exercises and diet recommendations|the aerobic exercises in form of treadmill training intensity of exercises moderate intensity, target heart rate (THR) will be50-60% of heart maximum (HR MAX), time of session 40 min initial 10 min warm up exercises on treadmill in low intensity and active phase20- 30 min intensity will increase until patient reach to THR then intensity decrease until session will be ended by cooling down phase for 10 min . The volunteers will perform exercises 3 times per week for 12 weeks
15795012|NCT04492540|Other|diet recommendations|control group will receive diet recommendations for 12 weeks
15795013|NCT04492527|Behavioral|Telehealth coaching sessions|Participants will be receiving a 2-month coaching session intervention that will be delivered via telephone or video-conferencing. Each of the 6 sessions will be 30-45minutes long and one-on-one with a student coach. In each session, coaches will review the participants' health behaviours and assess their knowledge about behavioural risks factors for chronic diseases and their current behaviours. The coaches will then provide information about the health risks of poor health behaviours, and benefits of change. Health behavioural goals will be established through a collaborative process. The coaches will then assist participants to develop readily achievable action plans that participants will follow in between coaching sessions as a means to realize their health goals. Adherence and modifications to the action plans will be discussed at the follow-up coaching session to promote health accountability.
15795014|NCT04492514|Drug|Mavrilimumab|treatment infusion
15795015|NCT04492514|Drug|Placebo|Placebo infusion
15795016|NCT04492501|Procedure|Therapeutic Plasma exchange|1-1.5 plasma volume exchange, 2/3rd plasma should be replacing with FFP to avoid coagulopathy, adequate dieresis to prevent volume overload, 1-5 sessions in total, 1 session daily
15795159|NCT04491253|Behavioral|Social support for diabetes self-management|Four individualized intervention sessions, every two weeks with a duration of 40 minutes.
15795017|NCT04492501|Biological|Convalescent Plasma|"Convalescent plasma as part of replacement therapy (200-400ml) if reported within 14 days of illness. An IgG titer of > 1.320 will be considered suitable for use. It will be Collected from person previously infected with Covid-19 and meet following criteria;
~After 28 day of illness till 3 months
~Symptom free 2 weeks prior to donation
~Negative two consecutive PCRs any time between initial positivity and before donation
~Anti SARS-CoV2 IgG positive, IgM negative
~Fulfills healthy donor criteria as per WHO/AABB guidelines
~Volume of plasma to be collected: 900-1200 ml through Apheresis OR plasma separated from phlebotomy donation"
15795018|NCT04492501|Drug|Tocilizumab|A predefined number of patients having evidence of cytokine release storm with normal procalcitonin level for three consecutive days, a normal blood culture and IL-6 level > 3 times ULN will be given 1-2 doses of Tocilizumab (80mg IV) . Following contraindications to Tocilizumab will be considered (Allergy to any monoclonal Ab, ANC < 1000, Platelets < 50, ALT or AST > 5 times ULN, Pregnancy and breast feeding, Post TB lung). Some patients will receive it alone in addition to standard treatment whereas in few patients where indicated it will be given in combination with MSC or Remdesivir or both
15795019|NCT04492501|Drug|Remdesivir|It will be given to selected patients who have evidence of hypoxemia and presented with in 14 days of illness. For adults requiring invasive mechanical ventilation the dosage of remdesivir is a single loading dose of 200 mg sta on Day 1 followed by once daily maintenance doses of 100 mg IV for 9 days (days 2 through 10). For adults not requiring invasive mechanical ventilation 5 standard doses will be used. However, patients with known hypersensitivity to Remdesivir, multi organ failure, ALT > 5 times ULN and GFR < 30ml/minute will not be given Remdesivir. In some patients, where indicated other novel treatments including MSC therapy, Tocilizumab and therapeutic plasma exchange will be given.
15795020|NCT04492501|Biological|Mesenchymal stem cell therapy|Single Dose of 2 x 106 cells/kg will be administered either alone or in combination with other novel therapies. At Armed Forces Bone Marrow Transplant Centre (AFBMTC), MSCs will be isolated from bone marrow harvested cells. About 50ml bone marrow will be collected from iliac crest using aseptic technique in syringes primed with anticoagulant. The collected sample will be diluted with Phosphate Buffer Saline (PBS) and MSCs will be separated using density gradient centrifugation. After resuspension the cells will be seeded at a fixed concentration of 100,000 cells/cm2 in specially designed flasks and incubated at 37Oc in 5% CO2. Medium will be changed after every third day till harvesting of MSCs from the flasks. Once confluent (approximately day 20) the cells will be harvested with sterile techniques using Trypsin- EDTA solution.
15795021|NCT04492488|Drug|MRG002|Administrated intravenously
15795022|NCT04492475|Drug|Interferon beta-1a|Rebif (R) is a purified 166 amino acid human interferon beta glycoprotein with an amino acid sequence identical to natural fibroblast derived human interferon beta. Each 0.5 mL prefilled syringe contains 44 mcg of interferon beta-1a, 4 mg human albumin, USP; 27.3 mg mannitol, USP; 0.4 mg sodium acetate; and water for injection, USP.
15795023|NCT04492475|Other|Placebo|The interferon beta-1a placebo contains either 0.5 mL 0.9% normal saline or 0.5 mL sterile water for injection.
15795024|NCT04492475|Drug|Remdesivir|Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.
15795025|NCT04492462|Other|Formal Physical Therapy|Patients will undergo standard physical therapy following their surgery with a physical therapist in an office
15795026|NCT04492462|Other|Self-directed Physical Therapy|Patients will undergo self-directed physical therapy in the comfort of their own home by completing a list of exercises and stretches without the direct supervision of a physical therapist in a physical therapist office
15795027|NCT04492449|Other|congenital malformation|congenital malformation
15795028|NCT04492436|Drug|thrombomodulin alfa|Weight based dose of reconstituted treatment administered through intravenous drip infusion on Day1 of each chemotherapy cycle
15795029|NCT04492436|Drug|Placebo|Weight based dose of reconstituted treatment administered through intravenous drip infusion on Day1 of each chemotherapy cycle
15795030|NCT04492423|Diagnostic Test|VerifyNow PRUTest|VerifyNow PRUTest for platelet aggregation
15795031|NCT04492410|Other|rapid serological test|screening using a rapid serological test with a drop of blood from a finger prick
15795032|NCT04492397|Device|Test Contact Lens|Subjects will be randomized to wear test lenses.
15795033|NCT04492397|Device|Control Contact Lens|Subjects will be randomized to wear control lenses.
15795035|NCT04492358|Drug|Colchicine|Colchicine: ideal dose of 0.3 mg/kg/day (or the dose that approximates that adjusted for age, weight and kidney function, and 0.5 mg and 1 mg tablets)
15795036|NCT04492358|Drug|Prednisone tablet|Prednisone 60 mg/day, in a single dose, during 3 days
15795037|NCT04492358|Drug|standard of care|The standard treatment used in each site will be administered to the patients assigned to the control group.
15795038|NCT04492345|Other|Isokinetic reeducation|Conventional rehabilitation session and isokinetic during 7 weeks
15795039|NCT04492345|Other|Conventional reeducation|Conventional rehabilitation session during 7 weeks
15795040|NCT04492332|Diagnostic Test|standard lumbar puncture|Subjects underwent a standard lumbar puncture to measure the intracranial pressure (ICP). ICP was measured invasively through lumbar space in the morning.
15795041|NCT04492319|Drug|Control Test|spermatic cord block by 9.5 ml Levobupivacaine 0.5% plus 0.5 ml 0.9 normal saline in each side
15795042|NCT04492319|Drug|Neostigmine|spermatic cord block by 9,5 ml Levobupivacaine 0.5% plus neostigmine 250 μg in each side .
15795126|NCT04491552|Diagnostic Test|Patients monitored with TruGraf and TRAC testing|This is an observational study there are no protocol mandated interventions. TruGraf and TRAC results will be utilized in conjunction with standard of care assessments to determine patient management.
15795048|NCT04492280|Drug|Hydrocortisone|After approval of the ethical committee of faculty of Medicine Ain Shams University and obtaining a written informed consent from all patients or their legal guardians, the study will be conducted on 66 patients subdivided randomly via computer closed envelopes method into 3 equal groups, 22 patients for each group; group HF (hydrocortisone & fludrocortisone), group H (hydrocortisone) and group C (control group).
15795049|NCT04492254|Drug|Enoxaparin|The treatment provided will be enoxaparin sodium 40mg/0.4 mL. All doses will be provided in pre-filled, single-dose syringes for subcutaneous injection.
15795050|NCT04492241|Drug|Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution|TID for 6 month after enrolment Glass oral bottle, 10 ml/bottle. Study Arm Component: Ginkgo Leaf Extract and Armillariella Mellea Powder, konjac (sweetener), purified water.
15795051|NCT04492241|Drug|Simulation of Ginkgo Leaf Extract and Armillariella Mellea Powder Oral Solution|TID for 6 month after enrolment Glass oral bottle, 10 ml/bottle. Placebo Arm Component: Caramel color (food color), konjac (sweetener), sucrose octaacetate (food additive), sodium benzoate (food additive), purified water.
15795052|NCT04492228|Other|Ketogenic diet|Eucaloric Ketogenic diet % composition : protein (27%), lipids (67%), carbohydrates (6%: <30g/day). In pts in artificial nutrition : Eucaloric Ketogenic parenteral nutrition % composition : aminoacids (27%), lipids (67%), carbohydrates (6%: <30g/day)
15795053|NCT04492215|Behavioral|Interaction between patient and trained general practitioners in motivational interviewing|Impact of the medical interview on the patient
15795054|NCT04492202|Other|Survey|The survey will be sent to health professionals via online link.
15795055|NCT04492176|Device|CO2 fractional laser（ACUPULSE,Lumenis）|gradually withdrawn from inside to outside of vaginal. with Acupulse Femtouch mode therapy ( hexagonal spot , 10-12.5m J/cm2 , density 5-15%) ,once a month for a total of 3 times
15795056|NCT04492163|Device|TTFields|"TTFields treatment will consist of wearing four electrically insulated electrode arrays on the head. The treatment enables the patient to maintain regular daily routine.
~Other Names:
~• TTFields"
15795057|NCT04492150|Drug|Dextrose 5%/Nacl 0.3% Inj_#3|250 mL/hour of dextrose 5% intravenous drip
15795058|NCT04492150|Drug|Saline|250 mL/hour of normal saline intravenous drip
15795059|NCT04492137|Procedure|Cannulation technique|"Participants in the ultra early NKF group will be submitted to 2 standard cannulation attempts (2 contacts with the papilla) before starting NKF. If any of these 2 attemps is successful, NKF won't take place. If NKF is indeed performed and cannulation is not achieved within 8 minutes, the endoscopist is free to perform techniques other than NKF. On the other hand, participants in the standard cannulation group in which cannulation is not achieved within 8 minutes can cross-over to other advanced cannulation techniques (e.g. NKF). For ethical reasons we choose to exclude flat and intradiverticular/diverticular border papillas.
~During ERCP all participants will be submitted to PEP prophylaxis with rectal indomethacin. A pancreatic stent will be placed whenever there is cannulation or opacification of the Wirsung duct.
~For the purposes of the study, a dedicated form (attached) will be created with the various variables to be analyzed"
15795060|NCT04492111|Procedure|post-extraction dental implant|Insertion of a dental implant immediately after tooth extraction.
15795061|NCT04492098|Diagnostic Test|MAIT cells|1- Decidual tissues will be washed in phosphate buffer saline (PBS), and then preserved in Rosewell Park Memorial Institute (RPMI) 1640 medium supplemented with 100 U/mL penicillin, 100 mg/mL streptomycin and 5% fetal bovine serum (GIBCO BRL, Thermo Fisher Scientific, USA) until transfer to the laboratory. At the flow cytometry laboratory, the tissue samples will be minced finely and enzymatically digested by adding 3 ml collagenase enzyme type Ia and 2 ml PBS for 40 minutes at 37°C in shaking water path at 100 r.p.m. Cell suspensions obtained will be filtered, then the pellet after centrifugation will be treated with red blood cells lysing solution and washed with PBS.
15795062|NCT04492085|Other|Questionnaire survey|A customized questionnaire will be delivered by the social software WeChat to explore the prevalence, potential reasons and solutions of workplace violence against physicians of obstetrics and gynecology in China
15795063|NCT04492072|Drug|Oxytocin|Intervention
15795064|NCT04492072|Drug|Misoprostol|Control
15795065|NCT04492059|Device|Blood flow restriction augmented physical therapy|Using a blood flow restriction cuff during physical therapy. It is a pressurized cuff that is used to decrease the amount of oxygen that is available to the muscle during exercise. This stimulates the muscle to believe it is in an anoxic state and can produce greater strength and hypertrophy with fewer reps and less weight which would mean less stress on a surgically repaired tendon.
15795066|NCT04492059|Other|Physical therapy|Completing traditional physical therapy.
15795067|NCT04492046|Other|Manual Lymph Drainage|Manual lymph drainage is an effective therapeutic method used in the conservative treatment of lipedema. The application was performed on both lower extremities for 45 minutes.
15795068|NCT04492046|Other|Bandaging|Multilayered compression bandaging techniques have an assisting role in the further reduction of the volume of the limb and enhance the continuous pump mechanism via the active involvement of muscle pumps. All patients received bandages following Manual lymph drainage application.
15795069|NCT04492033|Drug|ABL001|ABL001 will be administered biweekly.
15795070|NCT04492033|Drug|Paclitaxel|Paclitaxel will be administered weekly.
15795071|NCT04492033|Drug|Irinotecan|Irinotecan will be administered biweekly.
15795072|NCT04492020|Drug|Ubrogepant 100mg|For each qualifying prodrome event, 2 compressed tablets containing 50 mg of ubrogepant will be taken orally when the participant is confident that a headache will follow within 1-6 hours
15795073|NCT04492020|Drug|Placebo|For each qualifying prodrome event, 2 compressed tablets containing placebo will be taken orally when the participant is confident that a headache will follow within 1-6 hours
15795074|NCT04492007|Behavioral|Patient-Reported Outcomes-Informed Symptom Management System (PRISMS)|Participants will receive personalized self-care information and guidance based on their symptoms and signs of complications (e.g., skin infection, fatigue) from the web-based telehealth PRISMS program. They will also have access through this website a peer support online forum that is moderated by a research nurse as well as professional support through videoconferencing/telephone from the research nurse and also their healthcare providers at the hospital(s) if they experience moderate to severe symptoms and/or abnormal sign (e.g., body temperature is greater than 98.6 C
15795075|NCT04491994|Drug|HCQ|Tab HCQ 400mg 12 hourly day 0 followed by tab HCQ 200mg 12 hrly for next 5 days
15795651|NCT04487106|Drug|Trametinib|Given PO
15795076|NCT04491981|Procedure|Encapsulated Glass Ionomer Cement|Repair of restorations in primary molars using Encapsulated High Viscosity Glass Ionomer (RIVA Self Cure - SDI). No local anesthesia will be used. A portion of the former restoration and infected carious tissue can be removed if necessary, and then the restoration will be repaired with GIC (Glass Ionomer Cement).
15795077|NCT04491981|Procedure|Composite resin|Repair of restorations in primary molars using composite resin (Filtek Bulk Fill- 3M ESPE.) No local anesthesia will be used.A portion of the former restoration and infected carious tissue can be removed if necessary, and then the restoration will be repaired with CR (composite resin).
15795078|NCT04491968|Behavioral|Mindfulness Oriented Recovery Enhancement|MORE sessions involve mindfulness training to prevent opioid relapse and reduce pain, cognitive reappraisal to decrease negative affect and regulate opioid craving, and savoring to augment natural reward processing and evoke positive emotion. Each session begins with a mindful breathing meditation, followed by a debriefing session. The therapist then debriefs participants' homework practice of using mindfulness, reappraisal, and savoring skills to cope with pain and enhance well-being in everyday life. During this debrief of the homework. Next, new psychoeducational material is introduced. Sessions culminate with an experiential exercise, and close with a brief mindful breathing meditation. Participants are asked to practice 15 minutes of mindfulness/reappraisal/savoring skills each day.
15795079|NCT04491968|Other|Methadone Treatment as Usual|In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
15795087|NCT04491916|Drug|irone sucrose|drug ingredient: Ferric Hydroxide in complex with sucrose drug dosage form: 270injection/100mg/5ml/Amp
15795088|NCT04491903|Procedure|REBOA|Endovascular balloon occlusion of the aorta
15795092|NCT04491851|Diagnostic Test|68Ga-NODAGA-LM3 and 68Ga-DOTA-LM3 PET/CT|Patients will undergo PET/CT using 68Ga-NODAGA-LM3 (40ug peptide/150-200MBq) and 68Ga-DOTA-LM3 (40ug peptide/150-200MBq) on two consecutive days. The scan will be acquired at 1hour post-injection.
15795093|NCT04491851|Diagnostic Test|68Ga-NODAGA-LM3 and 68Ga-NODAGA-JR11 PET/CT|Patients will undergo PET/CT using 68Ga-NODAGA-LM3 (40ug peptide/150-200MBq) and 68Ga-NODAGA-JR11 (40ug peptide/150-200MBq) on two consecutive days. The scan will be acquired at 1hour post-injection.
15795094|NCT04491838|Drug|Pozelimab|Single subcutaneous (SC) injection
15795095|NCT04491825|Diagnostic Test|Skin suction blistering and skin biopsies|Skin suction blistering and skin biopsies will be used for the identification of potential proteomic biomarkers that can distinguish MF from eczema, psoriasis and healthy control skin.
15795096|NCT04491812|Other|Kinesio Tape|Elastic Kinesiology Tape
15795097|NCT04491812|Other|Physical therapy program|designed physical therapy program
15795098|NCT04491799|Diagnostic Test|Fecal calprotectin|Fecal calprotectin is a protein found in human neutrophils, and it is released during active periods of inflammation of intestine. The sensitivity and specificity has been reported at 93% and 96%, respectively in differentiating inflammatory bowel disease from irritable bowel syndrome in outpatient setting.
15795099|NCT04491786|Drug|Gabapentin|Gabapentin plus nefopam
15795100|NCT04491773|Drug|Tadalafil 20 MG|To study retinal and choriocapillary features in patients undergoing Tadalafil 20 mg orally, on alternate days, for more than 6 months.
15795101|NCT04491760|Other|Inspiratory Muscle Training|The inspiratory muscle training (IMT) will be carried out with a load of 30% of maximal inspiratory pressure (MIP) using a threshold inspiratory muscle trainer (c-type, Shengchang medical equipment factory, Yuyao city, China) at the beginning. During the hospital period, the resistance will increase incrementally, based on the rate of perceived exertion scored on the Borg scale (Borg, 1982). If the rate of perceived exertion less than 5, the resistance of the inspiratory threshold trainer will then be increase incrementally by 5%. The load for home-based IMT training will be set as the highest training load in the hospital. All patients will be required in sitting position during training, wearing nose-clips.
15795102|NCT04491747|Diagnostic Test|functional capacity|Six minute walk test used assessment of functional capacity.
15795103|NCT04491734|Dietary Supplement|maltosyl-isomalto-oligosaccharides (MIMO)|Digestion-resistant carbohydrate, ISOT-101, a specific formulation of maltosyl-isomalto-oligosaccharides (MIMO), that serves as a prebiotic, feeding selected bacteria that commonly inhabit the human GI tract.
15795154|NCT04491279|Procedure|Home 'Neuropilates' exercise instructions.|Participants will be given a home exercise programme weekly based on exercises from the neuropilates exercise class and will be asked to complete these independently at home twice more during the week and to keep a training diary.
15795104|NCT04491708|Other|Pilates exercises|The participants attended two half-hour Pilates exercise classes twice a week, for one month, to familiarize themselves with the exercises and to learn the 5 Pilates' principles. After the learning period, two experimental sessions were performed: a Mat Pilates session and a Reformer apparatus Pilates session. The order of each session was randomized and drawn beforehand. Each experimental session lasted about one and a half hours and the interval between the sessions was 48 hours. Participants were asked to not perform any exercise and to refrain from food or fluids except water eight hours prior to each experimental session. Prior to the start of the experimental sessions, participants received a standard breakfast of 321 kcal that was 76% (61 g) carbohydrate, 8% (6,7 g) protein, 16% (5,9) fat, provided by the study researchers. All sessions were conducted at the same time in the morning, and the room temperature (22°C) and humidity (40-50%) were controlled during the whole session.
15795105|NCT04491695|Drug|Tirofiban Hydrochloride|Tirofiban will use a loading dose, 0.4 μg/kg/min × 30 minutes, then 0.1μg/kg/min infusion for 71.5 hours.
15795106|NCT04491695|Drug|Oral antiplatelet|Aspirin, clopidogrel or other antiplatelet drugs. Loading dose will be considered if the patients is not on antiplatelet therapy.
15795107|NCT04491682|Drug|Megestrol Acetate|At a dosage of 160 mg/day
15795108|NCT04491682|Drug|Rosuvastatin|At a dosage of 10 mg/day
15795109|NCT04491669|Diagnostic Test|GFR - Glomerular Filtration Rate|"Chronic Renal Failure staging according to GFR by Chronic Renal Failure EPI is:
~Stage1 in which GFR>90 mil/min but evidence of kidney damage.
~Stage 2 GFR 60-89 mil/min.
~Stage 3 GFR 30-95 mil/min.
~Stage 4 GFR 15-29 mil/min.
~Stage 5 GFR<15 mil/min."
15795110|NCT04491656|Other|WALANT Technique|A technique commonly used in hand surgeries where the combination of lidocaine and epinephrine is used for local blood control, thus performing the procedure without a tourniquet
15795111|NCT04491643|Drug|Megestrol Acetate|At a dosage of 160 mg/day
15795112|NCT04491643|Drug|Rosuvastatin|At a dosage of 10 mg/day
15795113|NCT04491630|Behavioral|Self-Hypnosis (SH)|"Participants assigned to this condition will listen to a 20-minute recording with instructions of SH adapted from one of our team member's proposed model. First, the audio recording will introduce and orient the participant to SH. Then instruction in SH will be provided, including: (a) how to self-induce a hypnotic induction; (b) specific self-suggestions for comfort and ability to manage intense sensations; and (c) post-hypnotic suggestions that the participant will be easily able to use these hypnotic strategies on their own at a later time (i.e., in this case, during the Cold Pressor Arm Wrap procedures that will follow).
~A second 5-minute audio recording with instructions to guide the participant in SH will be provided during the second cycle of Cold Pressor Arm Wrap (CPAW)."
15795114|NCT04491630|Behavioral|Mindfulness Meditation (MM)|"Participants in the MM condition will listen to a 20-minutes recording with instructions in the use and application of Vipassana MM, adapted from the manual developed by one of our team members. First, the audio recording will focus on introducing the idea of attention to their breath, and of non-judgmental monitoring and acceptance of the all events and stimuli. Then a guided MM (body scan) experience will be provided.
~A second 5-minute audio recording with instructions to facilitate the MM (body scan) experience taught in the first audio recording will be provided during the second cycle of CPAW."
15795115|NCT04491630|Behavioral|Christian Prayer (CP)|"Participants in this condition will listen to a 20-minute recording with CP instructions. These instructions will be adapted from the existing on-line biblical meditations from the Society of Jesus (www.passo-a-rezar.net). First, the recording will introduce and orient the participant to CP. Then, a text of the Bible will be read twice, followed by a brief suggestion of prayer.
~A second 5-minute audio recording with instructions to facilitate the CP experience taught in the first audio recording, including the recording of a text of the Bible followed by a brief suggestion of meditation and relaxing music, will be provided during the second cycle of CPAW."
15795116|NCT04491617|Other|Standard opioid prescribing|Patients are routinely prescribed opioid medications in addition to non-opioids.
15795117|NCT04491617|Other|Restrictive opioid prescribing|Patients are prescribed non-opioid pain medications, and will be prescribed opioids only if they request them.
15795118|NCT04491604|Biological|Topical Beremagene Geperpavec|Topical gel of non-integrating, replication-incompetent HSV-1 expressing the human collagen VII protein
15795119|NCT04491604|Other|Placebo|Matching masked inactive topical gel
15795120|NCT04491591|Other|Breast Reconstruction Education and Support Tool (BREASTChoice)|The tool is an interactive website and can be sent through My Chart and integrated into the electronic health record
15795121|NCT04491591|Other|Attention Control Website|-(https://www.cancer.gov/types/breast/reconstruction-fact-sheet)
15795122|NCT04491591|Other|Clinician Survey|-Questions regarding opinions on shared decision-making with answers ranging from 1-7 with 1=strongly disagree or harmful to 7=strongly agree or beneficial. The higher the score the more the physician agrees with shared decision making.
15795123|NCT04491578|Behavioral|"ACP programme Have a Say"|It is a theory-driven advance care planning programme specifically designed for PWEDs or persons with MCI and their family caregivers. The intervention is underpinned by the Bandura's self-efficacy model. Each dyad of participants will receive a 4-session ACP programme, which consists of educational components, guided reflection, and dyadic ACP discussion, guided by ACP facilitators and an ACP booklet. It is composed of 2 group-based sessions and 2 dyadic discussions. One hour for each session, and once weekly. Dyads of participants will be provided with information about the trajectory of dementia, their future healthcare needs and caring options. Their values and care preferences on future care will be elicited in a consistent manner. They will be supported to have an individualized ACP discussion. By the end of the programme, each dyad of participant will be given an ACP booklet documenting the ACP process.
15795124|NCT04491578|Behavioral|Attention-control health talks|Dyads of participants in the control group will receive 4-session health talks. One hour for each session, and once weekly. The contents of the health talks are neither dementia-specific nor related to ACP, and cover general health information for elderly, such as drug safety, home safety, exercise and health, and healthy diet. This is to differentiate the effect of the intervention from the effect of the extra time and attention given to the participants.
15795125|NCT04491565|Other|educational video|an interactive educational video was viewed by participants in the intervention arm.
15795155|NCT04491279|Procedure|Supervised Neuropilates Group Class|Will attend a once-weekly 60-minute neuropilates exercise class over 6 weeks facilitated by the principle investigator (a chartered physiotherapist who is also a pilates instructor).
15795127|NCT04491539|Behavioral|Finding Respect and Ending Stigma around HIV (FRESH)|The Finding Respect and Ending Stigma around HIV (FRESH) intervention is theoretically informed by Social Cognitive Theory (SCT) and Interpersonal Contact theory (ICT) and was specifically designed for delivery in high-stigma settings, such as Dominican Republic. FRESH was originally developed in Africa to address HIV-related stigma, and later was adapted to address intersectional stigmas experienced by sexual and gender minorities (SGM) living with HIV in the United States Deep South. To our knowledge, FRESH will be the first intervention to address intersectional stigmas experienced by men who have sex with men, transgender women, and people living with HIV in clinical settings in the Spanish-speaking Caribbean.
15795128|NCT04491526|Drug|TAMSULOSIN Mepha Ret Depocaps 0.4 mg|"0.4mg/day Tamsulosin hydrochloride (TAMSULOSIN Mepha Ret Depocaps 0.4 mg) from 5 days prior to the day of surgery, at the day of surgery and for 1 day following surgery. (5+1+1)"
15795129|NCT04491526|Drug|Control Intervention|One placebo capsule matching the active study drug per day from 5 days prior to the day of surgery, at the day of surgery and for 1 day following surgery. (5+1+1)
15795130|NCT04491513|Diagnostic Test|Computed tomography angiography|Computed tomography angiography for the detection of proximal coronary lesions in patients in the work-up for TAVI
15795131|NCT04491500|Behavioral|High attitude environment|The participants will go to 4000m altitude to work for two weeks.
15795132|NCT04491487|Other|pre-operative counselling|pre-operative Speech-Language Pathology (SLP) counselling before Total Laryngectomy
15795133|NCT04491474|Drug|Lidocaine Hydrochloride|While performing these procedures, 1 ml of 2% lidocaine hydrochloride and 1 ml of %0.9 saline will be used for creating a solution of 2 ml of 1% lidocaine for nerve block. Also 2 ml of saline will be used for placebo effect. For blocking the GON region 0.75 ml of 1% lidocaine will be applied and 0.75 ml of saline for placebo effect(8). During applying to the SON region 0.25 ml of 1% lidocaine for blockage and 0.25 ml of saline for placebo effect will be used(8). The GON injection site was planned to be 2 cm lateral and 2 cm below the occipital protrusion and the SON injection site was planned as the area with frontal incisor in the orbital arch
15795134|NCT04491474|Drug|Placebo|There will be injection of %0.9 saline to bilaterally great occipital nerve and to bilaterally supraorbital nerve.
15795135|NCT04491461|Dietary Supplement|Herbal tea blend|1 cup of freshly brewed tea from an herbal tea blend.
15795136|NCT04491461|Dietary Supplement|Warm water|1 cup of warm water
15795137|NCT04491448|Behavioral|Social needs screening|Interview and referral for non-medical health-related social needs
15795138|NCT04491435|Diagnostic Test|Summated Xerostomia Inventory|structured interview by a dedicated researcher to obtain a score of the summated xerostomia inventory (SXI)
15795139|NCT04491435|Diagnostic Test|Sialometry|unstimulated whole saliva (UWS) flow measurement
15795140|NCT04491422|Combination Product|Integrated Next Steps Counseling with Real-Time Drug Level Feedback|Integrated next steps counseling with real-time drug level feedback using point-of-care urine tenofovir testing at quarterly visits
15795141|NCT04491409|Other|Best Practice|Undergo standard of care
15795142|NCT04491409|Other|Medical Chart Review|Medical charts reviewed
15795143|NCT04491396|Behavioral|Gentle Yoga and Yogic Breathing|"Gentle Yoga (GY) postures can be done while seated on a chair (sometimes called Chair Yoga) and have been shown to benefit people with symptoms associated with cancer.12 However, Yoga is under-studied in the area of scleroderma. While most traditional Yoga postures can be practiced by anyone, people with scleroderma often have limited physical movement and can be prone to injury. Gentle Yoga postures are physically much easier to do than traditional Yoga and, thus, may be more accessible for SSc patients with musculoskeletal and other impairments. Gentle Yoga postures that are done while seated on a chair also combine easily with YB, but little is known about the specific benefits of the GY+YB combination (GYYB). Further study is needed to determine whether GYYB may be an effective strategy for improving QoL in SSc patients. The Yoga intervention to be used in this study specifically involves GY done while seated in combination with YB."
15795144|NCT04491383|Drug|Tocovid Suprabio (HOV-12020)|Dietary supplement: Tocotrienol (HOV-12020) Palm oil-derived vitamin E, tocotrienol
15795145|NCT04491383|Other|Placebo|Dietary supplement: Placebo. Placebo.
15795146|NCT04491370|Drug|Polatuzumab vedotin|All patients will receive a myeloablative conditioning regimens (BEAM or CBV, as selected by the treating physician) followed by autologous stem cell transplant (ASCT). All patients on this study will receive an autologous stem cell transplant (ASCT) on Day 0 followed by supportive care including the drugs sargarmostim and filgrastim until blood counts are stable. If a complete, partial, or stable response is achieved following ASCT, the patient will receive an IV dose of Polatuzumab Vedotin once every 21 days until he/she receives 8 doses.
15795147|NCT04491357|Drug|Calcium Gluconate|Intravenous calcium gluconate within 4 hours of skin closure after total thyroidectomy
15795148|NCT04491357|Drug|Normal saline|Normal saline within 4 hours of skin closure after total thyroidectomy
15795149|NCT04491331|Procedure|prone position|Unsupported prone position with arms along the body in neutral position will be used first without any supportive device except support of heels with a soft cylindrical device, head will be held in a neutral position using prone head rest. After recording of all measered values, the prone position using the prone position support system will be tested. The support system allows free movement of the lower thorax and abdomenal wall, upper arms are elevated and angled in 90 degrees (in shoulders and elbows). Heels will be positioned at the level of the heart using a supportive cylindrical device. Head will be held in a neutral position using prone head rest.
15795150|NCT04491318|Other|Observational|Hemophilic arthropathy patients who will not receive any intervention. The dependent variables (frequency of hemarthrosis, pain, joint state and range of movement) in the joints will be evaluated: elbows, knees and ankles.
15795151|NCT04491305|Procedure|Surgically treated women with endometriosis and confirmed diagnosis|Women with indication for surgery or diagnostic laparoscopy will be enrolled in study.
15795152|NCT04491292|Other|Questionnaire Administration|Complete questionnaires
15795153|NCT04491279|Procedure|Home 'General' exercise instructions.|Participants will be given a home exercise programme weekly based on exercises from the general exercise class and will be asked to complete these independently at home twice more during the week and to keep a training diary.
15795156|NCT04491279|Procedure|Supervised General Exercises Group Class|Will attend a once weekly, 60-minute generalized exercise class which will be designed by a chartered physiotherapist to address strength, cardiorespiratory fitness and mobility
15795160|NCT04491240|Drug|EXO 1 inhalation|Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10^10 of nanoparticles (exosomes) of the first type.
15795161|NCT04491240|Drug|EXO 2 inhalation|Twice a day during 10 days inhalation of 3 ml special solution contained 0.5-2x10^10 of nanoparticles (exosomes) of the second type.
15795162|NCT04491240|Drug|Placebo inhalation|Twice a day during 10 days inhalation of 3 ml special solution free of nanoparticles (exosomes).
15795163|NCT04491214|Other|quality of live assessment|quality of live assessment 3 moth and 6 moth after ointensive care hospitalisation using SF36.
15795164|NCT04491201|Other|Customized questionnaire|A customized questionnaire will be delivered by the social software WeChat to the specific hospital which has been randomly sampled, and all physicians of Obstetrics and Gynecology in this hospital will fill the questionnaire anonymously.
15795165|NCT04491188|Dietary Supplement|Bacillus subtilis DE111|1 x10-9 CFU Bacillus subtilis DE111 probiotic
15795166|NCT04491188|Dietary Supplement|Placebo|Maltodextrin placebo
15795167|NCT04491175|Device|DuoTherm|New combination device comprising a sculpted low back plate with multiple sensory modalities held in place with a neoprene belt capable of being tightened with patient control of variations in sensory modalities.
15795168|NCT04491175|Device|Sham|A sculpted low back plate with a neoprene belt capable of being tightened.
15795169|NCT04491162|Other|Body weight support treadmill training + conventional therapy|"Conventional gait therapy was done based on the principles of the proprioceptive neuromuscular facilitation (PNF) and Motor Relearning program (MRP) concepts.
~Patients in intervention arm were additionally trained with a 40% body weight support and a comfortable walking speed on treadmill for twenty minutes. The training, which was conducted three times a week, for period of two weeks."
15795170|NCT04491162|Other|Conventional therapy|Conventional gait therapy was done based on the principles of the proprioceptive neuromuscular facilitation (PNF) and Motor Relearning program (MRP) concepts.
15795171|NCT04491149|Device|virtual reality glasses|In the intervention arm, women undergoing amniocentesis/foeticide will use virtual reality glasses during the procedure.
15795172|NCT04491136|Drug|ACEI/ARB|initative ACE/ARB drug for 6 months in this study
15795173|NCT04491136|Drug|ARNI|initative ARNI drug for next 6 months in this study
15795174|NCT04491110|Other|Music Therapy|We are aiming to use music therapy, with pre-recorded favoured music, as a complementary treatment in oncological patients in palliative care, as well as on the carer. It will be done by using mobile telephones.
15795175|NCT04491110|Other|simulation with therapeutic education|Basic therapeutic education repetition performed to all caregivers and oncological patients in palliative care, through mobile phones.
15795176|NCT04491097|Device|Panavia V5 resin cement|Missing lateral incisor teeth will be restored by zirconia ceramic RBFDs and adhesively bonded with Panavia V5 resin cement.The preperation and restoration of the tooth will be done according to to the guidelines for ordinary prosthetic techniques.
15795177|NCT04491097|Device|Panavia F2.0 resin cement|Missing lateral incisor teeth will be restored by zirconia ceramic RBFDs and adhesively bonded with Panavia F2.0 resin cement.The preperation and restoration of the tooth will be done according to to the guidelines for ordinary prosthetic techniques.
15795178|NCT04491084|Drug|FLT3 Ligand (CDX-301)|Fms-like tyrosine kinase 3 (FLT3) ligand is a potent hematopoietic growth factor that mobilizes stem cells and greatly increases the number of circulating dendritic cells (DCs) in blood and organs.
15795179|NCT04491084|Biological|anti-CD40 antibody (CDX-1140)|CD40 is a key molecule in the regulation of immune responses whose activity can be modulated using antibodies. CD40 is a tumor necrosis factor receptor superfamily member expressed on antigen presenting cells, including dendritic cells, as well as a host of other cell types, including a wide range of tumor cells
15795180|NCT04491084|Radiation|SBRT|For subjects on Arm 1, SBRT will be delivered concurrently with FLT3 ligand during Week 1 of study therapy. If only one lesion is being treated, SBRT should be completed during week 1 (e.g., with daily treatments for a 5-fraction course of treatments every other day for a 3-fraction course). In cases where multiple lesions are being treated with SBRT (Arm 1 or Arm 2) or if treatment is interrupted due to technical issues or intercurrent illness, SBRT may extend beyond Week 1.
15795181|NCT04491071|Diagnostic Test|Generalized Anxiety Disorder-7 (GAD 7)|test that will evaluate persistent and excessive worry about a number of different things. People with Generalized Anxiety Disorder may anticipate disaster and may be overly concerned about money, health, family, work, or other issues. Individuals with Generalized Anxiety Disorder find it difficult to control their worry.
15795182|NCT04491071|Diagnostic Test|Background questionnaire|questionnaire on the living conditions, socio-professional contexts and environmental conditions of the participants
15795183|NCT04491071|Diagnostic Test|Impact of COVID-19 questionnaire|status of the patient with regard to the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 virus)
15795184|NCT04491071|Diagnostic Test|Confinement and Communication During the COVID-19 Pandemic|know the experience of containment and isolation during the pandemic
15795185|NCT04491071|Diagnostic Test|Mental Health questionnaire|welfare effect
15795186|NCT04491071|Diagnostic Test|Patient Health Questionnaire (PHQ-9)|assess depression during the pandemic
15795187|NCT04491071|Diagnostic Test|Post Traumatic Stress Disorder questionnaire (PTSD-8)|Assessing the trauma of subjects during the pandemic
15795188|NCT04491071|Diagnostic Test|Experiences in Close Relationship Scale questionnaire (ECR-S)|Measuring social ties and attachment of subjects
15795189|NCT04491058|Diagnostic Test|SSCT thickness measurement|Thickness measurement with ultrasound
15795190|NCT04491045|Other|Workshop Training on Multicomponent Collaborative Care for Depression|Hybrid Workshop Trainings on Stepped collaborative care model for depression that involves using a team-based approach to integrating depression care components (screening, psychoeducation, Behavior Activation therapy, and antidepressant medications) into primary care settings. This integration involves task-shifting mental health tasks from mental health specialist to community providers at the commune health stations.
15795191|NCT04491045|Other|Supervision|Ongoing supervision and coaching is provided to community health providers by local mental health specialist from the provincial psychiatric hospital for 6-9 months
15795192|NCT04491045|Other|Community-Engaged Learning Collaborative|The CELC group will receive support for continuous quality improvement using a province-wide learning collaborative that will meet monthly for 3 months, followed by bi-monthly meetings for 12 months.
15795193|NCT04491032|Procedure|Caudal anesthesia|Caudal epidural injection will be performed after induction of general anesthesia.
15795194|NCT04491019|Other|Balance exercise group|Balance exercises will be carried out with a physiotherapist
15795195|NCT04491006|Drug|ATH-1017|Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe
15795196|NCT04491006|Drug|Placebo|Daily subcutaneous (SC) injection of Placebo in a pre-filled syringe
15795197|NCT04490993|Drug|APL-1202 in combination with Epirubicin|"Induction period: APL-1202 is administered for 12 consecutive weeks
~Maintenance period: after 12-week drug free period, APL-1202 is administered for another12 consecutive weeks as maintenance treatment
~Follow up period: APL-1202 is administered at every 3-month interval if no events occurred in the treatment period and until the occurrence of events or the end of the entire clinical trial Intravesical Epirubicin hydrochloride will be administered once weekly for consecutive 6-8 weeks in the induction period, followed by once monthly in the maintenance period until end of 12 months"
15795198|NCT04490993|Drug|Placebo in combination with Epirubicin|"Induction period: placebo is administered for 12 consecutive weeks
~Maintenance period: after 12-week drug free period, placebo is administered for another12 consecutive weeks as maintenance treatment
~Follow up period: APL-1202 is administered at every 3-month interval if no events occurred in the treatment period and until the occurrence of events or the end of the entire clinical trial Intravesical Epirubicin hydrochloride will be administered once weekly for consecutive 6-8 weeks in the induction period, followed by once monthly in the maintenance period until end of 12 months"
15795199|NCT04490980|Drug|butorphanol|Observed group:Intravenous drip of Butorphanol in patients after cesarean section;control group: intravenous drip of saline in patients after cesarean section
15795200|NCT04490967|Combination Product|Silymarin|Silymarin 1.4% cream will be used on the left side of the face twice daily (home use).
15795201|NCT04490967|Procedure|Salicylic acid|Patients will have salicylic acid 30% peeling on the right side of the face as a peeling session every two weeks. Sessions will be done by well trained physician.
15795202|NCT04490954|Device|brain biological electrical impedance tomography|Patients diagnosed with brain supratentorial tumors through MRI/CT are evaluated with brain biological electrical impedance tomography. And the brain biological electrical impedance tomography is used to monitor the cerebral edema situation of patients with brain edema
15795203|NCT04490954|Device|MRI/CT|Patients diagnosed with brain supratentorial tumors through MRI/CT
15795204|NCT04490941|Other|Ophthalmologist-delivered health education|The educational intervention will be conducted on-site by a qualified, experienced ophthalmologist at an ophthalmic center with goals of building awareness on diabetes symptoms, particularly on diabetic retinopathy, and its risk factors with appropriate management.
15795205|NCT04490941|Other|Usual care|Usual care follows standard procedure on diabetes management similar to the routine service provision.
15795206|NCT04490915|Drug|Crinecerfont|CRF1-receptor antagonist
15795207|NCT04490915|Drug|Placebo|Non-active dosage form
15795208|NCT04490902|Procedure|Limbal transplantation combined with central penetrating keratoplasty|Limbal transplantation combined with central penetrating keratoplasty with single donor cornea
15795209|NCT04490902|Procedure|Limbal transplantation combined with central penetrating keratoplasty|Limbal transplantation combined with central penetrating keratoplasty with mixed component cornea
15795210|NCT04490889|Diagnostic Test|NiPGT-A|NiPGT-A is the technique to screen the aneuploidy status of an embryo without invasion technique, such as biopsy. We use SCM to isolate cfDNA, then amplify and analyse the aneuploidy of embryo secreting this material using NGS technique.
15795211|NCT04490876|Procedure|3D Pars Plana Vitrectomy associated with Extensive Brilliant Blue G-Assisted ILM Peeling Method|After the injection of Brilliant Blue-G (BBG) into the vitreous cavity, the epiretinal membrane (ERM) with cellular proliferation on the surface of the retina did not stain clearly, while the internal limiting membranes did stain clearly. We peeled off the internal limiting membrane (ILM) underlying the ERM using the ILM forceps for the macular area and the serrated forceps for the remaining ILM beyond the vascular arcades (Grieshaber, Alcon Laboratories, Inc., Fort Worth, Texas (Figure1) and enhanced membrane viewing with filters on the Ngenuity system. Restaining with BBG was needed and perfluorocarbon liquid PFCL was injected with a coaxial Dual Bore cannula (MedOne) to flatten the retina.
15795212|NCT04490863|Device|Rad-67 Pulse oximeter & DCI Mini sensor|Noninvasive pulse oximeter that measures hemoglobin
15795213|NCT04490850|Procedure|Blood sample|Blood sample
15795214|NCT04490837|Diagnostic Test|ELISA and Rapid test to detect antibodies against COVID-19|Ycovid-19 aims to be a rapid diagnostic test for SARS-CoV-2 infection, which will allow a reliable diagnosis to be made in 10 minutes, and on easy-to-use devices
15795215|NCT04490824|Device|KELEA Excellerated Water|Water with increased kinetic activity as assessed by published methods of the PI
15795216|NCT04490824|Device|Water Without an Elevated Level of KELEA|Bottled water without an elevated level of KELEA, as shown by proprietary testing will be provided as a control.
15795217|NCT04490811|Other|no intervention. observational cohort study|blood sampling is part of care
15795218|NCT04490798|Procedure|Electroacupuncture|The electro-acupuncture device was a biphasic pulse generator. It was used with maximum tolerable intensity of current and a frequency of 3 Hz. The points were selected according to the Traditional Chinese Medicine meridian theory to treat the different painful syndromes. Just as in a regular acupuncture treatment, needles are inserted into acupuncture points but small crocodile clips are then attached to the ends of needles to connect them to an electro-acupuncture device. In traditional acupuncture the inserted needles are manually vibrated to induce a response whilst in electro-acupuncture the bi-phasic current results in a constant (controlled) vibration of the needles and a direct electrical stimulation.
15795219|NCT04490785|Procedure|MRI|1 MRI 5 days after surgery (-1; +4 days), with intravenous administration of gadolinium
15795220|NCT04490785|Biological|Postoperative dosage of released troponin|Dosage of troponin I Hs H4, H8, H12, H24, H48, and H72 after the aortic cross-unclamping.
15795221|NCT04490772|Diagnostic Test|Laboratory tests|Laboratory tests such as CBC, Liver function and CRP
15795222|NCT04490759|Diagnostic Test|Quantra System|Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
15795223|NCT04490746|Other|with no intervention, Collect samples|only with observation,there is no need to intervene
15795652|NCT04487106|Drug|Venetoclax|Given PO
15795224|NCT04490733|Behavioral|dual-task walking|Participants will receive 3 times interventions during 10th to 12th course of chemotherapy and 12 weekly phone-call to assess effect and barriers of dual-task walking.
15795227|NCT04490707|Drug|Azacitidine|Elderly or unfit for intensive therapy patients with acute myeloid leukemia who had entered CR receive maintenance therapy contained Azacitidine
15795228|NCT04490707|Drug|Lenalidomide|Elderly or unfit for intensive therapy patients with acute myeloid leukemia who had entered CR receive maintenance therapy contained Lenalidomide
15795229|NCT04490694|Drug|Lenvatinib|Intervention Description：lenvatinib will be administered daily (for patients <60kg, lenvatinib 8mg bid po for patients ≥60kg, lenvatinib 12mg bid po) until documented disease progression, development of unacceptable toxicity, participant request, or withdrawal of consent.
15795230|NCT04490694|Procedure|TACE|Patients will be treated with TACE 2-4 weeks after randomization: the blood supply of the tumor will be evaluated by transradial / femoral artery approach, microcatheter will be inserted into the tumor feeding artery, and lipiodol plus epirubicin emulsifier will be injected (40mg epirubicin will be added to each 10ml lipiodol, the total amount should less than 20ml, epirubicin 40-60mg). Gelatin sponge particles / microspheres are used to strengthen embolization. Blood biochemical examination will be performed within 1 week before TACE, 3 days after operation and 1 month after operation.
15795231|NCT04490681|Drug|Ertugliflozin|Fixed dose Ertugliflozin (5mg)
15795232|NCT04490681|Drug|Placebo|Placebo group
15795233|NCT04490668|Biological|Human albumin|Patients received intravenous human albumin after gastric cancer surgery. Overall quantity of human albumin were recorded.
15795234|NCT04490655|Behavioral|Active somatosensory training|Patients in the experimental group will be required to move the robotic handle using their paretic arm from the start position to a visual target shown on screen. However, patients' paretic arm will be occluded from vision throughout the training session. They will make the reaching movement by depending on their proprioception of the arm position in space, without relying too much on the vision of their arm. Haptic guidance will be provided as somatosensory cues while participants are actively moving. Positive reinforcement will also be given for each successful movement that reaches the target in the form of a pleasant audio tone, visual feedback, and a running score. Assessment will be performed before and after the completion of the whole 15 training sessions.
15795235|NCT04490655|Behavioral|Motor-based training|Patients in the control group will also be required to propel the robotic handle using their paretic arm to a target location. This training covers the same centre-out reaching movements but without any emphasis on proprioception, where the view of the paretic arm will not be occluded. However, no haptic guidance will be provided during the reaching movement. Positive reinforcement will still be given to inform the participants of their trial outcomes. Assessment will be performed before and after the completion of the whole 15 training sessions.
15795236|NCT04490642|Other|Questionnaire|Final version Childhood Bladder and Bowel Dysfunction for 5-12 years old questionnaire in Korean language to patients who never encountered beforehand in other available languages (Dutch, English).
15795237|NCT04490629|Device|Lyoplant Onlay|Lyoplant Onlay is a kind of latest artificial Dura Mater
15795238|NCT04490629|Device|DURAFORM|DURAFORM is a kind of conventional artificial Dura Mater
15795239|NCT04490616|Other|rTMS treatment|"A two-site rTMS stimulation delivered by a Magstim unit featuring a double 70 mm cooled coil will be applied.
~MCI patients will be randomly assigned to one of the two study groups:
~RR-Gr will receive 4 weeks of rTMS stimulation of the right temporo-parietal junction (RTPJ) and medial prefrontal cortex (MPFC);
~PL-Gr will receive sham stimulation of the RTPJ and MPFC during the first 2 weeks followed by 2 weeks of real stimulation. Each week of rTMS treatment will consist of five sessions (50 min, one per day).
~For each area target, a total of 2000 pulses at 20Hz, 3-s train duration, and 28-s inter-train interval at 100% motor threshold (MT) will be delivered per session. A fixed intensity of MT will ensure a more consistent spatial spread of TMS effects in subjects' brains not influenced by differences in individual MT. In the sham condition, a sham coil will be used.
~Each session lasted for about 60 min including time for set up and 50 min of stimulation."
15795240|NCT04490603|Behavioral|Virtual reality experience|Patients are to experice virtual reality with virtual reality experience equipment (headsets, headphones, smartphones) and virtual reality experience programs. The equipments and programs are commercialized products on the market rather than medical products.
15795241|NCT04490590|Drug|Chidamide+ Etoposide|Patients will receive the treatment of and chidamide and etoposide capsule, and those who have achieved CR（complete response）or PR（partial response）or SD(stable disease)will continue the treatment.
15795242|NCT04490577|Other|Pilates exercises|Pilates exercises are a combined exercise procedure including strengthening and stretching. Pilates exercises are performed with different equipment for example; therabands, mats, reformer, etc.
15795243|NCT04490577|Other|Whole body vibration|Whole-body vibration gives vibration to the body with a platform at different frequencies (Power-plate). The participant performed exercises on the platform.
15795244|NCT04490564|Diagnostic Test|PD-L1 Kit|Clinical performance of PD-L1 kit in CTCs of peripheral blood and tumor tissue samples
15795245|NCT04490551|Diagnostic Test|Risk-based logistic regression model|The intervention will be a risk-based logistic regression model that takes multiple variables into account to calculate the risk of advanced neoplasia as an outcome.
15795246|NCT04490551|Diagnostic Test|FIT|FIT is a stool-based test that detects human blood in faeces.
15795247|NCT04490538|Diagnostic Test|Transthoracic echocardiography|Conventional transthoracic echocardiographic examination at the intensive care unit.
15795248|NCT04490525|Device|Telerehabilitation|Blood pressure (iHealth Neo/BP5s), weight (iHealth Lina), step counters(Fitbit Inspire & Charge 3), sleep sensor (Emfit QS), and tablet (iPad Air 2).
15795249|NCT04490512|Biological|FluBHPVE6E7|Multiple subcutaneous, intradermal or intramuscular administrations
15795250|NCT04490499|Biological|HBVAXPRO™|Single 0.5 mL intramuscular dose
15795251|NCT04490486|Biological|UCMSCs|100 x 106 (100 million) UCMSCs delivered via peripheral intravenous infusion.
15795252|NCT04490486|Other|Placebo|Placebo, a solution of 1% human serum albumin in Plasmalyte A, delivered via peripheral intravenous infusion
15795654|NCT04487093|Drug|neoantigen vaccine + anti-angioge|neoantigen vaccine + anti-angioge
15795253|NCT04490473|Other|survey work|Survey forms will be sent to individuals online. Information about the study will be given to individuals with the informative text at the beginning of the questionnaire form. Individuals who agree to participate in the study will fill in the questionnaire and send it back online.
15795254|NCT04490460|Dietary Supplement|WBF-0031|Medical food formulation WBF-0031
15795255|NCT04490434|Drug|DWP14012|DWP14012 40mg, bid
15795256|NCT04490434|Drug|Celecoxib|Celecoxib 200mg, bid
15795257|NCT04490434|Drug|Naproxen|Naproxen 500mg, bid
15795258|NCT04490434|Drug|Meloxicam|Meloxicam 15mg, qd
15795259|NCT04490421|Drug|Camrelizumab combined with Apatinib, Etoposide and Cisplatin|Camrelizumab combined with Apatinib, Etoposide and Cisplatin
15795260|NCT04490408|Procedure|long surgical bypass|long surgical bypass and hybrid approaches in patients with multilevel critical lower limb ischemia.
15795261|NCT04490408|Procedure|Hybrid approach|Hybrid approach including bypass and endovascular revascularization
15795262|NCT04490395|Behavioral|Engage PA|Engage PA will consist of a 2-session intervention delivered to participants at the medical center or virtual visit by their study therapist, and includes a wearable personal fitness monitor for tracking their daily activity levels throughout.
15795263|NCT04490395|Other|Treatment as Usual plus (TAU+)|The comparison condition will receive treatment as usual throughout the study, and are given a wearable personal fitness monitor for tracking their daily activity levels throughout the study.
15795264|NCT04490382|Device|32 channel external stimulator|Patients will be stimulated by the 32 channel external stimulator via leads placed as part of standard care neuromodulation. Then patients will undergo various tasks.
15795265|NCT04490356|Behavioral|Legacy Intervention|The Legacy intervention is a nutrition and exercise protocol delivered using video conference technology. The Legacy protocol incorporates behavioral strategies along with nutrition and exercise to maintain and extend functional benefits of obesity treatment.
15795266|NCT04490343|Diagnostic Test|Abdominopelvic low dose CT|Patients with urinary stones will undergo multiple computed tomography (CT) examinations
15795267|NCT04490330|Other|questionnaire|AUDIT questionnaire (alcohol use disorders identification test)
15795268|NCT04490317|Diagnostic Test|Cardiac MRI|"Cardiac MRI be taken to CO poisoned patients
~Cardiac CT be taken to CO poisoned patients
~TTE be taken to CO poisoned patients
~Brain MRI be taken to CO poisoned patients
~Neurocognitive function tests be taken to CO poisoned patients
~Laboratory tests be taken to CO poisoned patients"
15795269|NCT04490317|Procedure|Hyperbaric oxygen therapy|"Hyperbaric oxygen therapy be used for CO poisoned patients
~Therapeutic hypothermia be used for CO poisoned patients"
15795270|NCT04490304|Other|durability of posterior soft tissue repair|how durable is the posterior soft tissue repair after total hip arthroplasty in primary osteoarthiritis patients?
15795271|NCT04490291|Other|chronic pain team|enrollment in chronic pain team at study site
15795272|NCT04490291|Other|chiropractic team|enrollment in chiropractic team/intervention at study site
15795273|NCT04490278|Other|Medical Record Review - Inpatient Treatment|Patient characteristics, medical history, and information regarding their inpatient treatment from the electronic medical record
15795274|NCT04490278|Other|Online Questionnaires|Patients will complete online questionnaires related to their physical, cognitive and mental health function and inquire about current treatments. The multiprofessional CoV-PICS clinic practitioners will evaluate their responses and, combined with information obtained during their virtual visits, formulate a suggested treatment plan and needed referrals.
15795275|NCT04490265|Behavioral|Problem-solving treatment|included in arm descriptions
15795276|NCT04490265|Behavioral|Supportive Psychotherapy|included in arm descriptions
15795277|NCT04490252|Dietary Supplement|Fasting mimetic diet|Fasting mimetic diet for 5 days, another cycle after 25 days
15795278|NCT04490239|Drug|Intranasal heparin sodium (porcine)|Intranasal heparin sodium
15795279|NCT04490226|Dietary Supplement|Beta-Hydroxybutyrate as Ca-Mg-salt, active|24 hour intervention with ketone body supplements additional to a normal diet (isocaloric diet in total) to induce ketosis (exogenous ketone bodies), in a metabolic chamber at physical activity level of 1.6, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.6.
15795280|NCT04490226|Dietary Supplement|ketogenic diet (KetoCal® 4:1 Neutral, Nutricia GmbH, Erlangen, Germany), active|24 hour interventions with ketogenic isocaloric diet to induce ketosis (endogenous ketone bodies), in a metabolic chamber at physical activity level of 1.6, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.6.
15795281|NCT04490226|Dietary Supplement|fasting, active|36 hours of fasting, in a metabolic chamber at physical activity level of 1.6, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.6.
15795282|NCT04490226|Dietary Supplement|fasting, inactive|"36 hours of fasting, in a metabolic chamber at physical activity level of 1.3, after one day of isocaloric diet in a metabolic chamber at physical activity level of 1.3.
~The same intervention is reproduced one week later."
15795283|NCT04490213|Other|Allevyn, Aquacel and Tegaderm, Mediskin|Wound dressing tested earlier on donor sites, in this study scar outcome between the 3 dressing groups are compared.
15795284|NCT04490200|Device|VESTA respirator|The protocol will be composed by the use of the VESTA respirator for 21 days (approximately 8 consecutive shifts lasting 6 to 12 hours, followed by approximately 36 hours of rest). Each participant will receive a total of approximately 8 respirators, with instructions for a maximum usage time of 6 hours. Therefore, participants will receive 1 respirator to be used in each shift of 6 hours, and 2 respirators in shifts of 12 hours. All participants will receive a booklet with guidelines and training in the use and proper handling of the respirator. All respirators will be sterilized and packaged in the laboratory, to ensure that they are not contaminated before use by the participants. The intervention will not change the participants' routine, considering that they already follow instructions for the use of protective personal equipment (PPE) and the proposed intervention will follow all local regulations and guidelines for the use and conservation of PPE and semi facial respirators.
15795306|NCT04490005|Other|pupillometry|evaluation of pupillary reflex by using the Neuroptics Pupillometer every 4 hours during ICU stay
15795307|NCT04489979|Other|Antibiotics|Children with epididymitis / orchitis who were treated by antibiotics in addition to analgetics.
15795655|NCT04487080|Drug|Amivantamab|Participants will receive amivantamab intravenously.
15795285|NCT04490200|Device|Conventional N95 respirator|The protocol will be composed by the use of the N95 respirator for 21 days (approximately 8 consecutive shifts lasting 6 to 12 hours, followed by approximately 36 hours of rest). Each participant will receive a total of approximately 8 respirators, with instructions for a maximum usage time of 6 hours. Therefore, participants will receive 1 respirator to be used in each shift of 6 hours, and 2 respirators in shifts of 12 hours. All participants will receive a booklet with guidelines and training in the use and proper handling of the respirator. All respirators will be sterilized and packaged in the laboratory, to ensure that they are not contaminated before use by the participants. The intervention will not change the participants' routine, considering that they already follow instructions for the use of protective personal equipment (PPE) and the proposed intervention will follow all local regulations and guidelines for the use and conservation of PPE and semi facial respirators.
15795286|NCT04490187|Behavioral|Motor Learning|"Over three consecutive days, each child will perform five blocks of Purdue Pegboard Test: one block before, three blocks during, and one block after tDCS. Each block consists of three repetitions of Purdue Pegboard Test with the right hand. The children have to place pins into a pegboard as fast as they can in 30 seconds. It will take up to 10 minutes of brain stimulation time.
~After the Purdue Pegboard Test, each child will receive cognitive-based intervention for printing skills for 20 minutes while receiving tDCS. Printing Like a Pro! (Montgomery 2017) -a cognitive approach to teaching printing to primary school-age children-will be used to teach letters which each child has the most difficulty printing legibly as identified on a formal assessment of handwriting-ETCH (manuscript) (Amundson 1995)."
15795287|NCT04490161|Other|intravenous reinstallation of cerebrospinal fluid|10ml of CSF will be taken under sterile conditions from the external ventricular drain and immediately administered intravenously.
15795288|NCT04490148|Device|remote pulmonary function testing|Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
15795289|NCT04490148|Device|standard pulmonary function testing|Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
15795290|NCT04490148|Behavioral|Nurse Respiratory Health Coaching (NRHC)|"Nurse Respiratory Health Coaching - The NRHC intervention follows the teamlet model described by Bennett et al. [Bennett2010], made up of the research coordinator who performs respiratory testing, and the nurse practitioner who coaches using the GROW (goals, realities, options, wrap-up) model."
15795291|NCT04490135|Behavioral|Group psychotherapy|As described above
15795292|NCT04490109|Biological|B244|B244 suspension
15795293|NCT04490109|Biological|Vehicle|Vehicle suspension
15795294|NCT04490096|Drug|[11C]-PBR28|"A dose of ≤ 20 mCi (approximate range for most studies is anticipated to be 5-20 mCi) of [11C]-PBR28 will be administered by IV injection to the patient under the direct supervision of a Nuclear Medicine Authorized User. A lesser activity may be injected if, in the opinion of a nuclear medicine authorized user complete imaging data could be generated.
~Subjects will undergo an approximately 90 minute dynamic PET/CT scan over the brain starting at approximately the same time as the [11C]-PBR-28 injection. Scans will be acquired using a Philips PET/CT time-of-flight Ingenuity scanner (Philips Healthcare, Cleveland, OH, USA). At the end of the dynamic imaging the participant will be allowed to get off the scanner."
15795295|NCT04490083|Procedure|Extra corporeal shock wave lithotripsy|ESWL will be performed with a third generation electromagnetic lithotripter (Delta Compact, Dornier Med Tech, Germany) This has both fluoroscopy and ultrasound imaging facility. Radio opaque calculi will be targeted directly while a naso pancreatic tube (NPT) was placed for all radiolucent calculi and contrast was passed through this to localize the calculi. Between 5000 and 6000 shocks were delivered per session with frequency of 90 shocks per minute. The aim will be to fragment the calculi to <3 mm or demonstrate a decrease in heterogeneity or density of the calculi in the main pancreatic duct. Shocks will be delivered on consecutive days till fragmentation is achieved. If there is no fragmentation after four sessions of ESWL the procedure will be labeled as unsuccessful and patient will be advised surgery. Procedures will be performed under epidural anesthesia.
15795296|NCT04490070|Behavioral|Cognitive Stimulation|The caregiver training program consisted of applying the cognitive stimulation model of the CUIDA-2 program. This application included theoretical training made up of three modules: 1) person-centered care, 2) communication strategies, and 3) mediated cognitive stimulation strategies. The training was given in two group sessions of two hours each, plus 50 hours of individual practice, either on the job (in the case of professional caregivers) or in the home (in the case of family caregivers), in both cases supervised by psychologists who were experts in the program. In these individual practice hours, the caregivers were required to keep a weekly log. Here they had to plan in advance the activities that they were going to carry out with the older adult, and once they had taken place, they had to record how they were done and how the older adult had responded.
15795297|NCT04490057|Drug|Nicotine patch, nicotine gum, nicotine nasal spray, nicotine inhaler|Participants will be prescribed both long-acting and short-acting nicotine replacement therapy.
15795298|NCT04490057|Drug|Varenicline or bupropion|Participants will be prescribed varenicline (Chantix) or bupropion (Wellbutrin).
15795299|NCT04490057|Behavioral|Contingency Management|Particpants will be financially rewarded for abstinence to tobacco.
15795300|NCT04490044|Other|Under & Over rehabilitation tool|Under & Over is a tool consisting of a 40cm x 40cm white plastic board, two coloured laces and a series of patterns to complete. It enables people to create patterns by threading each lace under, and over the board. It has been designed and developed with people whose upper limb function is affected by their MS. Administration time can be dependent on the person completing it.
15795301|NCT04490031|Drug|Ketamine Hydrochloride|patient in Ketamine group will be given Ketamine as sedative agent
15795302|NCT04490018|Biological|Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine MenACYW conjugate vaccine|Pharmaceutical form:Liquid solution for injection Route of administration: Intramuscular
15795303|NCT04490018|Biological|Meningococcal group A, C, W-135, and Y conjugate vaccine|Pharmaceutical form:Powder and solvent for solution for injection Route of administration: Intramuscular
15795304|NCT04490018|Biological|Human Papillomavirus 9-valent Vaccine 9vHPV|Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
15795305|NCT04490018|Biological|Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine Tdap-IPV|Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
15795308|NCT04489966|Behavioral|Aerobic training|The intervention was aerobic rhythmic training under the guidance and supervision of a professional. The aerobic training program required participants to exercise 3 days/week for 60 minutes/session (including 5-10 minutes of warm-up and 50 minutes aerobic training and 5-10 minutes to relax). All patients received an open class, relate to diabetes health education．
15795309|NCT04489953|Other|Viral Load|For the Clinical and Immunologic criteria, viral load was done retrospectively on stored plasma samples. Whereas for the Clinical, Immunologic and Virologic criteria, viral load was done in real-time
15795310|NCT04489940|Drug|Bintrafusp alfa|Participants will receive an intravenous infusion of 1200 milligrams (mg) bintrafusp alfa once every 2 weeks until confirmed disease progression, unacceptable toxicity, study withdrawal or death.
15795311|NCT04489927|Device|Tcore|Temperature Measurement of standard care versus the Tcore measurement
15795312|NCT04489914|Device|High-Flow Oxygen Therapy|high-flow oxygen therapy after percutaneous transfemoral aortic valve replacement
15795313|NCT04489901|Other|Olive oil|To apply 10 cc (4 tablespoons) of extra virgin olive oil to the entire abdomen by hand without massaging twice a day in the morning and evening.
15795314|NCT04489888|Drug|Pembrolizumab|Pembrolizumab 200 mg IV infusion given on Day 1 of each 21-day cycle
15795315|NCT04489888|Drug|Carboplatin|Carboplatin AUC 5 mg/mL/minute IV infusion given on Day 1 of each 21-day cycle
15795316|NCT04489888|Drug|Paclitaxel|At investigator's choice, paclitaxel 100 mg/m^2 IV infusion given on Day 1 and Day 8 of each 21-day cycle or paclitaxel 175 mg/m^2 IV infusion given on Day 1 of each 21-day cycle
15795317|NCT04489875|Behavioral|Chewing Gum|The intervention would be chewing gum. The patients in the intervention arm would be asked to chew gum for 15 minutes before meals thrice a day.
15795318|NCT04489862|Biological|αPD1-MSLN-CAR T cells|Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of αPD1-MSLN-CAR T cells. During αPD1-MSLN-CAR T cells production, subjects will receive cyclophosphamide for the purpose of lymphocytes depletion，Cyclophosphamide 300 mg/m2/day IV infusion on days -5, -4 and -3. After lymphodepletion, subjects will receive one dose treatment with αPD1-MSLN-CAR T cells by intravenous (IV) injection. The initial dose of 1×10^5 CAR+ T cells/kg will be infused on day 0.
15795319|NCT04489849|Drug|Apixaban 2.5 MG|apixaban 2.5mg BID for 3 months in experimental group
15795320|NCT04489849|Other|Active Control|Medication other than anticoagulation
15795321|NCT04489836|Dietary Supplement|Glutalytic®|Glutalytic® capsule
15795322|NCT04489836|Dietary Supplement|DE111®|DE111® capsule
15795323|NCT04489836|Other|Meal A|Oatmeal porridge - serving of oat porridge (cooked) containing 50g of carbohydrates (excluding sugars); Wheat cereal - serving of wheat cereal providing 1g of gluten; Water - 125 mL
15795324|NCT04489823|Device|Amplatzer Valvular Plug III|Transcatheter closure of a paravalvular leak using Amplatzer Valvular Plug III
15795325|NCT04489810|Dietary Supplement|Placebo|Maltodextrin capsule manufactured to mimic the Glutalytic® and DE111® capsules
15795326|NCT04489810|Dietary Supplement|Glutalytic®|1 capsule containing 350 mg of Glutalyltic®
15795327|NCT04489810|Dietary Supplement|DE111®|1 capsule containing Bacillus subtilis DE111
15795328|NCT04489810|Other|Meal A|Oatmeal porridge - serving of cooked oats containing 50g of carbohydrates (excluding sugars); Wheat cereal - serving of wheat cereal providing 1g of gluten; Water - 125 mL
15795329|NCT04489810|Other|Meal B|Refrigerated oatmeal - serving of refrigerated oats containing 50g of carbohydrates (excluding sugars); Wheat cereal - serving of wheat cereal providing 1g of gluten; Water - 125 mL
15795330|NCT04489797|Drug|Acalabrutinib|Participants will receive single oral dose of acalabrutinib on day 1 as per the arms they are randomized.
15795331|NCT04489797|Drug|Rabeprazole|Participants will receive twice daily oral dose of 20 mg rabeprazole on days -3, -2, and -1.
15795332|NCT04489784|Device|Infrared Laser|An aluminum gallium arsenide (AlGaAs) diode laser device (Twin laser, MMOptics, São Carlos, SP, Brazil) was used. The irradiation parameters were as follows: infrared laser (808 nm wavelength) with a spot area of 0.04 cm2, and an average optical power of 100 mW operated in a continuous mode during 1 minute per point, leading to an irradiance of 2,500 mW/cm2, energy of 6 J and fluence of 125 J/cm2 per point. The laser was applied on ballerina's feet twice a week during three months.
15795335|NCT04489745|Radiation|SBRT|
15795336|NCT04489745|Drug|Androgen deprivation therapy (ADT)|
15795337|NCT04489732|Biological|Autologous bone-marrow derived, interferon gamma stimulated mesenchymal stromal cells|Submandibular injection of a single dose of autologous, bone-marrow derived, interferon gamma stimulated mesenchymal stromal cells
15795338|NCT04489719|Procedure|Biospecimen Collection|Undergo collection of blood samples
15795339|NCT04489719|Other|Questionnaire Administration|Ancillary studies
15795340|NCT04489719|Drug|Radium Ra 223 Dichloride|Given IV
15795341|NCT04489706|Drug|Arsenic trioxide for injection|Arsenic trioxide for injection, 0.16 mg/kg (maximum single dose is 10 mg), daily IV drip, d1 to d14, once every 28 days, for six cycles of treatment or until one of the following events occurs: Initiation of new anti-tumor therapy, disease progression, withdrawal of Informed consent form (ICF) and/or death.
15795342|NCT04489693|Behavioral|Ambulatory Care Coordinator Team (ACCT)|See arm description
15795343|NCT04489693|Behavioral|Comprehensive Care Physician Program (CCP)|see arm description
15795344|NCT04489693|Behavioral|Comprehensive Care Community & Culture Program (C4P)|see arm description
15795345|NCT04489680|Other|Educational|Teaching session
15795346|NCT04489667|Other|+STEP Implementation|All patients receiving care at five RWHAP-funded clinics will receive the intervention (+STEP), in which patient-reported outcomes (PROs) on mental health and substance use disorder (SUD) will be integrated into routine care, targeted training will be provided for frontline clinicians on best practices for mental health and SUD treatment, and telemedicine for mental health and SUD will be offered to patients in need of expanded access to services.
15795347|NCT04489654|Biological|deproteinized bovine bone mineral (DBBM) by OneXeno Graft. ( OneGraft, Germany)|deproteinized bovine bone mineral (DBBM) put in the gap between implant and labial shield
15795348|NCT04489641|Behavioral|Psychological treatment|Psychological treatment
15795349|NCT04489641|Drug|Medication|Pharmacological intervention
15795350|NCT04489628|Drug|Vitamin D3 or Placebo|): Participants will be given 8 capsules of either cholecalciferol 50,000 IU or placebo at study randomization. Participants will be instructed to take 4 capsules on receipt of the treatment package(Day 0), 2 capsules on Day 5, 1 capsule on Day 10, and 1 capsule on Day 15. A phone or text reminder will be included at Days 5, 10, and 15 to take the additional doses of vitamin D.
15795351|NCT04489628|Device|Doctella telehealth monitoring|Doctella device will be give to participants by the Emergency department as part of usual care to monitor heart rate, respiratory rate, oxygen saturation, and perfusion index vitals continuously for approximately 10 days. The study team will receive the vitals signs data (heart rate, respiratory rate, oxygen saturation, perfusion index, and temperature) retrospectively and will not be able to monitor patients in real time.
15795352|NCT04489602|Other|ObsQoR-10F Questionnaire|The ObsQoR-10F questionnaire consists of 10 items assessing different aspects of postpartum recovery: physical comfort and pain, physical independence and emotional status. It takes two minutes to complete all the items. If the patient is not able to read the questionnaire herself, a third person can ask the questions orally to the patient. If the patient has returned home with her child, she can be contacted by phone to complete the questionnaire. Each item is scored from 0 to 10 and the total score is the sum of the score for each item, which is a score from 0 to 110.
15795353|NCT04489589|Drug|Midodrine|10mg PO/NG q8h
15795354|NCT04489589|Drug|Placebo|10mg PO/NG q8h
15795355|NCT04489576|Procedure|Keratin hair treatment (Keratin Cure ®) versus (QOD Max ®)|Hair will be treated with 2 different types of keratin in groups 1 & 2. All steps of keratin application will be done in group 3 without keratin application as a control group.
15795356|NCT04489563|Device|i-ACT|Performing exercises with an adapted motion detection device (i.ACT) for 20-30 minutes.
15795357|NCT04489537|Biological|MarzAA|A cross over design to assess the efficacy of a dosing regimen of 60 µg/kg of MarzAA compared with standard of care for the treatment of bleeding episodes.
15795358|NCT04489524|Behavioral|individualized counselor-led MI sessions|Intervention consisted of four 60-min in-person sessions of AMI counseling and a packet of self help smoking cessation materials.
15795359|NCT04489524|Behavioral|general health education session|four in-person 60-min health education sessions and packets of general health self-help information, nutrition, exercise, and the harmful effects of tobacco.
15795360|NCT04489524|Behavioral|NRT|nicotine replacement therapy
15795361|NCT04489511|Drug|STG-001|Dose 1 or Dose 2 of STG-001 will be administered daily for 28 days to compare safety, pharmacokinetics and pharmacodynamics in Stargardt disease subjects.
15795362|NCT04489485|Behavioral|Teen Depression Module used for care|All teens coming for routine well child care to the enhanced group PCPs will have depression screening with strengths and goals and a depression screen with follow up suggestions for activities to help any depression symptoms, and treatment using the Teen Depression Module and offered a depression chabot. Suicide screening will be conducted.
15795363|NCT04489472|Dietary Supplement|Beet-it Juice|Patients will ingest 1 bottle (70ml) of beet-it juice (98% concentrated beet juice, 2% lemon juice containing 400 mg/6.5 mmol nitrate).
15795364|NCT04489459|Drug|Colistin|Intravenous colistin 9 MIU IV infusion over 2 hours loading dose followed by maintenance dose 4.5 MIU IV infusion over 2 hours q12 h
15795365|NCT04489459|Drug|Meropenem|Intravenous meropenem 2 g IV infusion over 30 minutes q8 h
15795366|NCT04489459|Drug|Tigecycline|Intravenous Tigecycline 100 mg IV infusion over 1 hour loading dose followed by maintenance dose 50 mg IV infusion over 1 hour q12
15795367|NCT04489446|Drug|Sildenafil|Patients allocated to this arm will receive Sildenafil 25mg every 8 hours orally for up to seven consecutive days.
15795368|NCT04489446|Drug|Placebo|Patients allocated to this arm will receive a matching placebo similar to Sildenafil pills used in the intervention arm. Placebos will be delivered orally every 8 hours for up to seven consecutive days.
15795369|NCT04489433|Drug|Dabrafenib and Trametinib|"The starting dose of the combination treatment will be administered as follows:
~Dabrafenib, 150 mg, twice daily (BID);
~Trametinib, 2.0 mg, once daily (QD)"
15795370|NCT04489433|Drug|Dabrafenib|If a dose reduction below 50 mg BID for dabrafenib is required, dabrafenib will be permanently discontinued, but the patient will be allowed to continue trametinib.
15795371|NCT04489433|Drug|Trametinib|If a dose reduction below 1.0 mg once daily for trametinib is required, then trametinib will be permanently discontinued, but the patients will be allowed to continue dabrafenib.
15795372|NCT04489420|Biological|CYNK001-IV|Planned Starting dose dor IV 1.2x10^9 cells/dose
15795373|NCT04489420|Biological|CYNK001-IT|Planned starting dose for IT 200 x10^6 +/- 50 x10^6 cells dose
15795374|NCT04489407|Device|Remote Photoplethysmography (rPPG) vital sign acquisition|Subject vital signs will be acquired using the rPPG app simultaneously with the conventional vital sign monitors and manual respiratory rate calculation.
15795375|NCT04489381|Drug|Nitazoxanide|Two nitazoxanide 300 mg tablets administered orally twice daily with food for 5 days
15795376|NCT04489381|Drug|Placebo|Two placebo tablets administered orally twice daily with food for 5 days
15795377|NCT04489381|Dietary Supplement|Vitamin Super B-Complex|Vitamin Super B-Complex administered orally twice daily to maintain the blind
15795378|NCT04489368|Radiation|Neo-Adjuvant Radiotherapy|Neo-Adjuvant Radiotherapy via any technique, delivered concurrently with Neo-Adjuvant Chemotherapy.
15795379|NCT04489368|Drug|Neo-Adjuvant Chemotherapy|Neo-Adjuvant Chemotherapy, delivered concurrently with Neo-Adjuvant Radiotherapy.
15795380|NCT04489368|Procedure|Esophagectomy|Esophagectomy, performed 4-6 weeks after completion of Neo-Adjuvant Concurrent ChemoRadiation
15795381|NCT04489355|Procedure|coronary artery bypass graft (CABG) with surgical ventricular restoration (SVR) and mitral repair (MR)|
15795382|NCT04489342|Device|IMU sensor test|Measurement of maximum range of movement in the spine; Ambulatory observational data while performing standardised functional tests
15795383|NCT04489329|Device|Ingestible Capsule|Participants will swallow capsule and undergo X-rays to establish transit
15795656|NCT04487080|Drug|Osimertinib|Participants will receive osimertinib capsules orally.
15795384|NCT04489329|Dietary Supplement|Probiotic|Participants will swallow a probiotic capsule and the sample collection capsule at the same time to establish concentration of strain in small intestine.
15795385|NCT04489316|Other|Narrative medicine curriculum|The curriculum will consist of three sessions in narrative medicine- i.e. discussing texts and poetry, and engaging in reflective writing as a group
15795386|NCT04489303|Behavioral|Caring Response App|Participants will receive the Caring Response mobile app containing the Virtual Patient Behavioral Response Training.
15795387|NCT04489303|Behavioral|Traditional Educational/Resources Program|Participants will receive a traditional educational/resources program, containing a workbook and online resources.
15795388|NCT04489290|Device|D005 Vaginal Mousse|D005 Vaginal Mousse is class IIa medical device for treatment of Bacterial Vaginosis.
15795389|NCT04489290|Other|Placebo|Placebo
15795390|NCT04489277|Device|Endovascular Arch Procedures|Endovascular Arch Procedures (TEVAR, Branch endografts, Fenestrated endografts)
15795391|NCT04489264|Drug|Transplant, Autologous|high dose chemotherapy followed by autologous stem cell transplantation
15795392|NCT04489251|Diagnostic Test|Protein Elisa analysis, microRNA analysis, whole exome sequencing|"ELISA Testing Procedure: The circulating levels of BMP 2, 4, 6, 7, 9 and 10, together with activin A and TGF-β as well as CHIP will be measured using streptavidin ELISA assays.
~Micro-RNA analysis: From 100µL of plasma, we will prepare small RNA libraries using TruSeq Small RNA Sample Preparation kit (Illumina Inc).
~TGF-B mutation evaluation: Blood from subjects with PH will also be analyzed for known genetic mutations in TGF-B pathway using whole exome sequencing."
15795393|NCT04489238|Other|Risk Factor Questionnaire|Participants, both cases and controls, will complete the CYOC risk factor questionnaire, preferably at the time of first visit
15795394|NCT04489225|Other|Observational|Observational only without any intervention
15795395|NCT04489212|Other|Medical Chart Review|Review of medical chart
15795396|NCT04489212|Other|Patient Observation|Undergo observation
15795397|NCT04489212|Other|Quality-of-Life Assessment|Ancillary studies
15795398|NCT04489212|Other|Questionnaire Administration|Ancillary studies
15795399|NCT04489199|Other|Questionnaire and semi-structured interview|questionnaire submitted by telephone 3 months, 6 months, 1 year, 5 years, and 10 years after the stroke/TIA. interview duration 20 to 40 minutes
15795400|NCT04489186|Device|Wearable device|Multimodal electrocardiography (ECG), bioimpedance (bioZ) and tri-axial accelerometry (ACC) monitoring with a single wearable device (Byteflies Sensor Dot) to derive heart rate, respiratory rate and actigraphy.
15795401|NCT04489173|Drug|trifluridine/tipiracil|"Study medication should be started within 3 days after completion of screening and continue until a study treatment discontinuation criterion is met.
~Trifluridine/tipiracil will be administered orally BID on days 1 through 5, with the first dose administered in the morning of day 1 of each cycle and the last dose administered in the evening of day 5, followed by a recovery period from day 6 through day 7. Trifluridine/tipiracil will be administered orally BID on days 8 through 12, with the first dose administered in the morning of day 8 of each cycle and the last dose administered in the evening of day 12, followed by a recovery period from day 13 through day 28. Each cycle will be 28 days."
15795402|NCT04489160|Drug|C1 Inhibitor, Human|6000 IU C1-INH
15795403|NCT04489160|Drug|Placebo|0.9% saline
15795404|NCT04489147|Drug|Metformin|metformin 850 mg orally twice daily along the cycle of ICSI
15795405|NCT04489134|Drug|Treatment A|Administration of a 3 mg dose of prolonged-release tacrolimus (Advagraf®)
15795406|NCT04489134|Drug|Treatment B|Administration of a 2 mg dose of LCP-tacro
15795407|NCT04489134|Drug|Treament C|Administration of a single 120 mg dose of immediate-release verapamil and a 3 mg dose of prolonged-release tacrolimus (Advagraf®)
15795408|NCT04489134|Drug|Treatment D|Administration of a single 120 mg dose of immediate release verapamil and a 2 mg dose of LCP-tacro
15795409|NCT04489134|Biological|Pharmacocinetik|Nine sampling points of 7 ml each will be taken on the first day at the CIC UIC and the last sampling point will be carried out at 24 hours from the administration the following morning.
15795410|NCT04489134|Genetic|Genetic|A genetic analysis to determine your characteristics for enzymes in your metabolism as well as transport proteins will be carried out. An additional 7 ml blood tube will be drawn for this purpose during the first period.
15795411|NCT04489134|Other|Selection visit:|"During this visit, it will be asked to sign the following consent and it will be carried out:
~a clinical examination (questioning and physical examination with measurement of height and weight);
~a blood test (18 mL);
~a blood pregnancy test if you are a woman;
~a cardiac assessment (electrocardiogram).
~These results should be normal."
15795412|NCT04489121|Drug|Omalizumab|For patients in the Omalizumab group, subcutaneous injections of Omalizumab based on the specific participant's weight and serum total IgE was performed 2 weeks prior the anticipated pollen season.
15795413|NCT04489108|Drug|Tranexamic acid|Tranexamic Acid 1g iv bolus as loading dose followed by 3g Tranexamic Acid infused over next 24 hours
15795414|NCT04489108|Other|Standard Medical Treatment|Standard Medical Treatment
15795415|NCT04489108|Other|Placebo|isotonic solution (saline)
15795416|NCT04489095|Diagnostic Test|Electrophysiology Study|After informed consent is obtained, patient will undergo TAVR as per usual standard of care. Using the same femoral vein access as is used standard for a portion of the TAVR procedure, an EPS will be performed during the TAVR procedure, immediately before and after valve implantation. The patient will recover on a general telemetry floor as per usual care, and the next day will undergo another EPS. This is not uncommonly done clinically for some patients after TAVR. At that point, based on the baseline EKG, intra-procedure findings, and EPS findings, the patient will either have a pacemaker implanted, a 30-day event monitor ordered, or neither of the above.
15795417|NCT04489082|Device|Near Infrared Laser Stimulation|10 minutes of transcranial near infrared laser stimulation
15795418|NCT04489069|Diagnostic Test|MRI|Magnetic Resonance Imaging (sturctural MRI, fMRI resting state and task related, DTI)
15795419|NCT04489069|Diagnostic Test|Clinical and Neuropsychological evaluations|Clinical interviews and neuropsychological tests (paper/pencil and computer based)
15795420|NCT04489069|Diagnostic Test|Drawing DNA sample|Saliva sample
15795459|NCT04488770|Drug|GSK3882347|Capsule of 10-200mg dose strength will be provided in labelled High Density Polyethylene (HDPE) bottles.
15795421|NCT04489056|Genetic|Swabs for microbiome analysis|After informed consent, vaginal swabs will be collected during speculum examination from the lateral vaginal wall and posterior fornix vaginae using a sterile cotton swab combined with an epithelial brush. A rectal swab will be collected by insertion of a sterile swab into the anal sphincter. Intraoperative swabs of the placenta and uterine cavity will be collected during caesarean section under sterile conditions. Neonatal swabs (buccal mucosa and skin) will be collected directly after delivery and in the neonatal period. Stool samples will be taken from the meconium, defined as first stool of the infant and the stool of the newborn in the neonatal period.
15795422|NCT04489043|Other|Exercise and healthy lifestyle recommendations|In the present study, renal transplant patients with proven prediabetes will do a planned exercise programme to test the impact of this treatment on the reversibility of prediabetes. Thus, the persistance of recurrency of prediabetes assessed by an Oral Glucose Tolerant Test (OGTT) at intermediate time points (3, 6 and 9 months) will be checked in order to increase the frequency and duration of aerobic exercise and eventually to add anaerobic/resistance training.
15795423|NCT04489030|Other|Magnifying narrow-band imaging endoscopy|During endoscopy, gastric mucosal patterns would be examined by magnifying narrow-band imaging.
15795424|NCT04489017|Dietary Supplement|PEA-LUT|PEA-LUT administration at the oral dosage of 700 mg x 2/day
15795425|NCT04489017|Dietary Supplement|PLACEBO|PLACEBO administration at the oral dosage of 700 mg x 2/day
15795426|NCT04489004|Procedure|Driver ablation+CPVI|Patients receive driver ablation and CPVI (circumferential pulmonary vein isolation).
15795427|NCT04489004|Procedure|Stepwise ablation|Patients receive stepwise ablation.
15795428|NCT04488991|Other|Cervical Cancer Rate|In the end of the Research, we will compare cervical cancer rates between groups
15795429|NCT04488978|Drug|Irbesartan/Amlodipine|QID
15795430|NCT04488965|Other|Autologous transplant|Autologous transplant obtained from cortical biopsy
15795431|NCT04488952|Device|nerve block combined with general anesthesia|Patients in this group receive nerve block combined with general anesthesia.
15795432|NCT04488952|Device|spinal anesthesia|Patients in this group receive spinal anesthesia.
15795433|NCT04488939|Device|Restylane® Skinboosters™ Vital (SBV)|Hyaluronic acid
15795434|NCT04488926|Dietary Supplement|micronized and ultra-micronized Palmitoylethanolamide (mPEA and umPEA, 300mg + 600mg) microgranules|Micronized and ultra-micronized Palmitoylethanolamide is on the market in Italy as a Food for Special Medical Purposes
15795435|NCT04488926|Other|Placebo microgranules 1800mg|Placebo was prepared to be indistinguishable from color and flavor from the Product
15795436|NCT04488926|Drug|Standard Therapy|(antidepressants, anticonvulsants, muscle relaxants, weak opiates, etc..) consolidated for at least 3 months
15795437|NCT04488926|Drug|Rescue Drug|Use as needed allowed
15795438|NCT04488913|Other|RACE-IT Pathway|This care pathway includes the evaluation of suspected acute coronary syndrome with high-sensitivity troponin I testing and further prognostication as needed with a modified HEART score
15795439|NCT04488913|Other|Standard of Care|Standard of care protocol that uses the 99th percentile troponin values for evaluation of suspected acute coronary syndrome and further prognostication using the HEART score
15795440|NCT04488900|Drug|CKD-508 single dose|Investigational drug
15795441|NCT04488900|Drug|CKD-508 multiple dose|Investigational drug
15795442|NCT04488900|Drug|Placebo|Matching placebo
15795443|NCT04488887|Diagnostic Test|Optical coherence tomography angiography|patients in all groups will be examined with optical coherence tomography angiography, for every eye 3 macular and 3 papillary scans will be performed by two different OCTA machines, analysis will be carried out to evaluate the repeatability and reproducibility of the test
15795444|NCT04488874|Drug|Sodium Lactate|"Sodium lactate is administered at 2.5mL/kg during the first surgical incision. Neurosurgeon will evaluate the brain relaxation using a validated scale once the dura is open. A stage 1(perfectly relaxed) or 2((acceptably relaxed) is considered satisfactory.
~Sodium Lactate and Mannitol 20% are used at an equimolar dose"
15795445|NCT04488874|Drug|Mannitol 20% Infusion|Mannitol 20% is administered intravenously at a dose of 5mL/kg, so 1g/kg, during the first surgical incision. Neurosurgeon will evaluate the brain relaxation using a validated scale once the dura is open. A stage 1(perfectly relaxed) or 2((acceptably relaxed) is considered satisfactory.
15795446|NCT04488861|Other|Non-interventional cohort study|Non-interventional cohort study
15795447|NCT04488848|Other|bolus glucose|bolus Glucose
15795448|NCT04488848|Other|continuous clucose|continuous clucose
15795449|NCT04488835|Other|Electromagnetic field therapy and transcutaneous electrical nerve stimulation|Both groups received conventional physical therapy treatment protocol. Moreover, group (A) has an additional TENS application and group (B) had PEMFS application. TENS and the PEMFT were applied once daily, three times per week for 20 minutes for each session. Assessment performed pre and post intervention using visual analogue scale (VAS) and estimation of the carbamazepine intake (CMI).
15795450|NCT04488822|Drug|Pexidartinib|400 mg twice daily for a total daily dose of 800 mg (each capsule contains 200 mg of pexidartinib for oral administration)
15795451|NCT04488809|Other|Exercise|Exercise sessions will include 10 minutes of warming up, 30 minutes of loading, and 10 minutes of cooling down. The exercises will be performed two times in a week for eight weeks.
15795452|NCT04488796|Behavioral|Assigned Strategies: Opt-in|Participants will be assigned two behavioural strategies with the opt-in choice structure
15795453|NCT04488796|Behavioral|Assigned Strategies: Active Choice|Participants will be assigned two behavioural strategies with the Active choice structure
15795454|NCT04488796|Behavioral|Assigned Strategies: Enhanced Active Choice|Participants will be assigned two behavioural strategies with the Enhanced Active choice structure
15795455|NCT04488796|Behavioral|Choice of Assignment: Opt-in|Participants will have the choice to be assigned strategies or to manage their own strategies. The strategies will be assigned using the Opt-in choice structure
15795456|NCT04488796|Behavioral|Choice of Assignment: Active Choice|Participants will have the choice to be assigned strategies or to manage their own strategies. The strategies will be assigned using the Active choice structure
15795457|NCT04488796|Behavioral|Choice of Assignment: Enhanced Active Choice|Participants will have the choice to be assigned strategies or to manage their own strategies. The strategies will be assigned using the Enhanced Active choice structure
15795458|NCT04488783|Dietary Supplement|zinc and ascorbate|oral zinc and ascorbate
15795461|NCT04488757|Diagnostic Test|functional Magnetic Resonance Imaging (fMRI)|Participants will undergo a one hour fMRI scan with pain-induction using heat-based QST protocol.
15795462|NCT04488757|Other|Allostatic Load Composite|All participants will be asked to provide saliva samples to measure cortisol response over time and dehydroepiandrosterone (DHEA) in addition to physiological measurements such as blood pressure/pulse, height/weight, and waist-hip ratio. Measurements will be taken at baseline and 4-month follow-up.
15795463|NCT04488744|Drug|Nicotine 0.2mcg/kg/s and 1.0mcg/kg/s|Nicotine infusion 0.2 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries), 0.2mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries), 1.0 mg nicotine delivered over 2.5 minutes (5 pulsed-nicotine deliveries) and 1.0 mg nicotine delivered over 10 min (20 pulsed-nicotine deliveries).
15795464|NCT04488731|Behavioral|Normal BMI and moderate coffee consumption|Normal BMI and moderate coffee consumption
15795465|NCT04488731|Behavioral|Normal BMI and heavy coffee consumption|Normal BMI and heavy coffee consumption
15795466|NCT04488731|Behavioral|overweight and moderate coffee consumption|overweight and moderate coffee consumption
15795467|NCT04488731|Behavioral|overweight and heavy coffee consumption|overweight and heavy coffee consumption
15795468|NCT04488718|Other|EnergieShake® Junior Powder Complete|Oral Nutritional Supplement
15795469|NCT04488705|Drug|ETD002 - single dose|Single ascending doses of ETD002
15795470|NCT04488705|Drug|Placebo - single dose|Single doses of placebo
15795471|NCT04488705|Drug|ETD002 - 7 day repeat dose|Twice daily doses of ETD002 for 7 days
15795472|NCT04488705|Drug|Placebo - 7 day repeat dose|Twice daily doses of Placebo for 7 days
15795473|NCT04488705|Drug|ETD002 - 14 day repeat dose|Twice daily doses of ETD002 for 14 days
15795474|NCT04488705|Drug|Placebo - 14 day repeat dose|Twice daily doses of Placebo for 14 days
15795475|NCT04488705|Drug|Salbutamol|Twice daily doses of salbutamol for 3 days (Days 5, 6 & 7)
15795476|NCT04488692|Other|Early intervention (Mobility functional training)|functional training focused on mobility (bed mobility, sitting balance, standing balance, and ambulation)
15795477|NCT04488692|Other|Sham intervention|friendly visit and education
15795478|NCT04488679|Other|direct pulp capping|teeth with exposed pulp during caries removal will be capped either with PRF followed by mta or mta alone directly on exposed pulp, in both groups restoration will be placed over mta
15795479|NCT04488666|Device|npSIMS|incisional NPWT
15795480|NCT04488653|Dietary Supplement|Oligopin®|French Maritime Pine Bark Extract - 100mg/day
15795481|NCT04488653|Dietary Supplement|Placebo|Maltodextrin
15795482|NCT04488640|Procedure|Thyroid biopsy with ultrasound|Patients with thyroid nodules who underwent ultrasound-guided core needle biopsy with a 20 gauge core needle biopsy apparatus were included in the study.
15795483|NCT04488627|Diagnostic Test|Conventional transthoracic echocardiographic examination at the intensive care unit.|Conventional transthoracic echocardiographic examination at the intensive care unit targeted to inferior caval vein examination from different views.
15795484|NCT04488614|Procedure|Breast Concervative or Meastectomy|National treatment guidelines in Norway
15795485|NCT04488601|Drug|Rapamycin|Rapamycin in 2 different dosage forms.
15795486|NCT04488601|Drug|Placebo|Placebo capsules
15795487|NCT04488588|Other|Kaplan Meier analysis|Kaplan Meier survival analysis was conducted to calculate the cumulative overall survival rates using Log Rank test for comparison between age groups
15795488|NCT04488575|Drug|EDP1815|EDP1815 is an orally administered monoclonal microbe
15795489|NCT04488575|Drug|Placebo|Placebo oral capsule
15795490|NCT04488549|Other|Survey|International E-survey
15795491|NCT04488536|Diagnostic Test|Clinical Frailty Scale|Frailty assessment
15795492|NCT04488523|Behavioral|Family-based Telehealth Intervention|"The Family Telehealth intervention focuses on improving parent-child relationships and communication.
~For the dyadic version, the intervention involves eleven hours of intervention material; it includes motivational interviews, individual and joint sessions co-led by two separate clinicians. The sessions will be delivered on a weekly basis.
~For the caregiver-only version, the intervention involves six hours of intervention material; it includes a motivational interview and individual sessions led by a single clinician. The sessions will be delivered on a weekly basis."
15795493|NCT04488497|Behavioral|Cardiovascular Risk Assessment for Patients with Rheumatoid Arthritis|This intervention will help people with RA get tested for hyperlipidemia so that they can later discuss with their physician how to better treat their increased risk for cardiovascular disease.
15795494|NCT04488497|Behavioral|Standard of care|Participants in this group will not receive peer coaches calls. They will receive additional educational materials about CVD risk and the regular care provided by their doctors.
15795495|NCT04488484|Other|Serology test follow-up|"The enrolled participants will be invited to visit ESS. They will then meet the occupational physician, who wil obtain their free, informed and written consent. The information and consent will be recorded in the personal medical follow-up file.The staff will then complete the self-questionnaire and the ESS physician will provide a prescription for the blood samples to be taken.
~In case of positive answers to one or more of the questions in this self-questionnaire, the enrolled participant will be contacted in order to schedule another post-COVID-19 consultation with additional examinations if needed (new COVID PCR, scanner, etc.)."
15795496|NCT04488458|Diagnostic Test|MIC or MBEC+MIC based treatment algorithm|"i) Non cell wall active standard of care antibiotic combination (MIC-guided) for 6 weeks.
~ii) Non cell wall active antibiotic combination according to a MBEC-based decision algorithm for 6 weeks."
15795497|NCT04488445|Behavioral|Strength training|3 sets of 3 to 5 repetitions with 4 minutes of rest between sets. 90% load of 1 maximum repetition of a resistance exercise
15795498|NCT04488445|Behavioral|Stretch and balance training|3 sets of 3 exercises of stretching and balance of one minute each. One minute of resting time between sets.
15795501|NCT04488406|Other|No Intervention|Not applicable to these subjects. There is no study-related intervention
15795657|NCT04487080|Drug|Lazertinib|Participants will receive lazertinib tablets orally.
15795502|NCT04488393|Device|MaterniT21 PLUS and GENOME Laboratory-Developed Tests|Both the MaterniT21 PLUS and GENOME are intended for use as laboratory developed test that analyze ccfDNA extracted from a maternal blood sample utilizing Massively Parallel Sequencing (MPS) technology.
15795503|NCT04488380|Other|dental restoration|Restoration of carious mandibular 2nd molar teeth either with high viscosity glass ionomer or nanohybrid composite resin
15795504|NCT04488367|Drug|Tranexamic acid|10 mg/kg IV TXA in the ED, repeat doses before skin incision and in PACU
15795505|NCT04488367|Drug|Normal Saline|100 mL 0.9% normal saline in the ED, 10 mg/kg IV TXA before skin incision and in PACU
15795506|NCT04488354|Combination Product|CLBR001 and SWI019|No study drug is administered in this study. Patients who have received CLBR001 autologous CAR-T cells will be evaluated in this trial for long-term safety and efficacy
15795507|NCT04488341|Other|aerobic exercises in addition to diet recommendations|aerobic exercises time of session 40-50 min initial 10 min warm up exercises on treadmill in low intensity and active phase 20- 30 min intensity will increase until patient reach to target heart rate then intensity decrease until session will be ended by cooling down phase for 10 min . The volunteers will perform exercises 3 times per week for 12 weeks
15795508|NCT04488341|Other|diet recommendations|control group will receive diet recommendations for 12 weeks
15795509|NCT04488328|Other|patients received the routine medical treatment in addition to pulsed magnetic therapy and moderate-intensity aerobic exercise for 12 weeks|patients received the routine medical treatment in addition to pulsed magnetic therapy and moderate-intensity aerobic exercise for 12 weeks(3 sessions/ week)
15795510|NCT04488315|Drug|Dexamethasone plus ropivacaine|Local scalp infiltration solution will consist of 30ml miscible liquid containing 10mg dexamethasone, 150mg ropivacaine and normal saline.
15795511|NCT04488315|Drug|Dexamethasone lipid microsphere plus ropivacaine|Local scalp infiltration solution will consist of 30ml miscible liquids containing 10mg dexamethasone lipid microsphere, 150mg ropivacaine and normal saline.
15795512|NCT04488315|Drug|Ropivacaine|Local scalp infiltration solution will consist of 30ml miscible liquids containing 150mg ropivacaine and normal saline.
15795513|NCT04488289|Other|Lifestyle|Cardiovascular risk and lifestyle
15795514|NCT04488276|Other|In-depth interviews|In-depth interviews will be conducted to understand how smoking partners of pregnant women perceive risks and behaviors related to SHS exposure and how can it be altered to decrease exposure of pregnant women to SHS. These will be conducted in peri-urban slums and rural settings of Rawalpindi district with expectant or new father who smoke and pregnant or new mothers exposed to SHS. Interview guide will be developed deductively as a result of the systematic review and will be piloted before its actual use. Trained interviewer will conduct in-depth interview using semi-structured interview guide and will record it with consent from respondents. This data will be transcribed and translated and coded by team of two researchers.
15795515|NCT04488250|Other|Robot Therapy|Robot Therapy
15795516|NCT04488237|Drug|Vitamin D|oral administration of Vitamin D in patients with acute leukemia treated with methotrexate
15795517|NCT04488224|Device|Nano-X Patient Rotation System|"The Nano-X prototype is a horizontal patient rotation system that immobilises participants while being rotated on the horizontal axis.
~This device will be used to rotate patients horizontally while cone-beam Computed Tomography (CBCT) projections are acquired."
15795518|NCT04488224|Radiation|Conventional CBCT scan|A conventional cone-beam Computed Tomography (CBCT) scan is acquired on standard radiotherapy machinery.
15795519|NCT04488224|Other|Psychometrically validated questionnaires|The Claustrophobia Questionnaire (CLQ), Short Form State/Trait Anxiety inventory (STAI) and Fast Motion Sickness (FMS) questionnaires administered. CLQ only once before the first session, STAI and FMS both before and after each Nano-X CBCT session.
15795520|NCT04488211|Other|Survey|The IVM survey will be structured as a series of open questions and multiple-choice questions.
15795521|NCT04488198|Other|Acupuncture|Patients receive 8 acupuncture sessions (1 session per week, 20 minutes per session) with acupuncture needles.
15795522|NCT04488198|Other|Placebo-Acupuncture|Patients receive 8 acupuncture sessions (1 session per week, 20 minutes per session) with placebo-needles.
15795523|NCT04488185|Biological|Secukinumab 300 mg|Secukinumab 300 mg administered s.c. (2 single-use prefilled syringes of 150 mg/mL), on Days 1, 8, 15, 22, 29, 57, 85.
15795524|NCT04488185|Other|Placebo|Placebo administered s.c. (2 single-use prefilled 1 mL syringes) on Days 1, 8, 15, 22, 29, 57, 85.
15795525|NCT04488172|Dietary Supplement|Multi-vitamin supplementation|Vitamin B6:100 mg/day Vitamin B9: 5 mg/day Vitamin D: 1000 IU/day Vitamin E: 400 IU/day Co-Q10: 100 mg/day
15795526|NCT04488159|Drug|Capecitabine|Tablet
15795527|NCT04488159|Drug|Oxaliplatin|Infusion
15795528|NCT04488159|Drug|Fluorouracil|Infusion
15795529|NCT04488159|Drug|Leucovorin|Infusion
15795530|NCT04488159|Device|Immunoscore® assay|Whole-slide tissue analysis of CD3+ and cytotoxic CD8+ T cells in the tumor and in the invasive margin
15795531|NCT04488159|Other|Physical exercise|Increasing stair walking exercise twice a week over 12 weeks total.
15795532|NCT04488133|Drug|Nusinersen|Administered as specified in the treatment arm.
15795533|NCT04488120|Device|transcatheter closure of secundum atrial septal defects in patients|transcatheter closure of secundum atrial septal defects in patients
15795534|NCT04488107|Drug|FCN-437c|- FCN-437c is a selective and potent CDK4/6 dual inhibitor, with broad antitumor activity in preclinical pharmacology models, favorable physical and pharmacokinetic (PK) properties, and acceptable toxicity profile in nonclinical studies.
15795535|NCT04488107|Drug|Letrozole 2.5mg|"Letrozole is the latest generation of aromatase inhibitor. Letrozole lowers estrogen levels in postmenopausal women, which may slow the growth of certain types of breast tumors that need estrogen to grow in the body.
~Letrozole is used to treat breast cancer in postmenopausal women. It is often given to women who have been taking tamoxifen (Nolvadex, Soltamox) for 5 years."
15795536|NCT04488094|Drug|[18F]FSPG|A radioactive dose of 200 MBq of the study drug with a total quantity of ≤ 100 µg will be administered as slow intravenous bolus injection over up to 60 seconds. PET/CT examinations will be performed at 60-75 min after the administration of [18F]FSPG.
15795537|NCT04488081|Drug|Remdesivir|Participants who receive remdesivir as part of their standard of care will be administered remdesivir by IV for up to ten days. Remdesivir 200mg loading dose on day 1, followed by 100mg IV once daily maintenance doses for 4 or 9 days.
15795538|NCT04488081|Drug|Pulmozyme|For high-flow nasal cannula (HFNC) 2.5 mg/2.5 mL nebulized BID; for mechanical ventilation (MV)5.0 mg/ 10 mL nebulized BID. Treatment course is 14 days total, return to room air or baseline oxygen use for 24 hours, or until hospital discharge, whichever comes first.
15795539|NCT04488081|Drug|IC14|4 mg/kg/day on Day 1, then 2 mg/kg/day on Days 2-4 as an IV infusion over 2 hours via peripheral or central vein
15795540|NCT04488081|Drug|Celecoxib Famotidine|Clecoxib = 400 mg PO/ PNGT BID for 7 days. Famotidine = The course of treatment is a total of 21 days. High dose80 mg PO/PNGT four times daily (QID) for 7 days. Upon completion of the high dose, subjects should receive a lower 40 mg PO twice daily (BID) for a course of 14 days. For those with a serum Cr corresponding to an eGFR 30-59 mL/min/1.73m2, reduce the dose to 40 mg PO QID for 7 days, followed by 20 mg PO twice BID for 14 days. Stop at hospital discharge if a subject is discharged before day 21.
15795541|NCT04488081|Drug|Narsoplimab|4 mg/kg, given as a 30-minute intravenous infusion (up to maximum of 370 mg/ infusion) twice weekly. If weekend narsoplimab administration is not feasible, administration day can be worked around aslong as the intervals do not exceed 2-3 days
15795542|NCT04488081|Drug|Aviptadil Acetate|100μg (microgram)in 1ml normal saline per dose. Drug solution is provided in a syringe for convenient filling of nebulizer and should be used neat (undiluted)
15795543|NCT04488081|Drug|Cyclosporine|5mg/kg/day given PO/NGT in two doses daily for 5 days while hospitalized as inpatients.
15795544|NCT04488068|Procedure|Sham Magnetic stimulation|Sham Magnetic stimulation for comparison.
15795545|NCT04488055|Behavioral|Crisis Line Facilitation (CLF)|CLF is a motivational interviewing-based intervention
15795546|NCT04488055|Behavioral|Enhanced Usual Care (EUC)|In addition to receiving the brochure, EUC condition participants will meet with a therapist (in-person or remotely) for approximately 15 minutes for a descriptive overview of the brochure.
15795547|NCT04488042|Other|Stapler-less gastrectomy|After the LSG stapler line removal by electrothermal bipolar-activated device (LigaSure Atlas™, Valleylab, Boulder, CO, USA), a stapler-less hand-sewn reconstruction was adopted. A single extra-mucosal running barbed suture (3/0 V-Loc™ suture; Covidien, Mansfield, MA, USA), incorporating sero- and submucosal gastric layers, closed the gastric tube.
15795548|NCT04488042|Other|Suture|No reinforcement was performed, the stomach was re-sleeved along a 40F bougie with Echelon Flex Endopath 60-mm linear stapler (Ethicon Endo-Surgery, Cincinnati, OH, USA) to reproduce standard volume of remnant LSG stomach and/or eliminating zig-zag shape of suture-line.
15795549|NCT04488029|Other|PCT|PCT is designed to deliver similar therapy as is conventionally provided in-clinic by a Speech Language Pathologist (SLP), which the patient can access from any location using the application installed on a supported tablet. The device functions by allowing clinicians to create a personalized therapy program for each patient from 75 categories of clinical therapies, which patients may access from their tablet device remotely. The PCT software is comprised primarily of authentication and an algorithm that suggests advancement of the therapy program based on observed patient deficits and progress.
15795550|NCT04488029|Other|Workbooks|Subjects in this group will be provided with a standard regime of paper workbooks (e.g. Workbook for Aphasia: Exercises for Expressive and Receptive Language Functioning; Brubaker, 2006) that are typically used by clinicians to practice therapy tasks with individuals. Notably, the control procedure employed here is similar to that employed on a large-scale study examining technology as a treatment option and involved usual care control group by Palmer and colleagues (2015).
15795551|NCT04488016|Drug|Treatment A- Part 1|Subjects will receive 100 mg acalabrutinib capsule, fasted state;
15795552|NCT04488016|Drug|Treatment B- Part 1|Subjects will receive 100 mg acalabrutinib tablet (Variant 1), fasted state
15795553|NCT04488016|Drug|Treatment C - Part 1|Subjects will receive 100 mg acalabrutinib tablet (Variant 1), fed state
15795554|NCT04488016|Drug|Treatment D- Part 1|Subjects will receive Rabeprazole 20 mg QD (fasted) at 2 hours before administration of 100 mg acalabrutinib tablet (Variant 1) and following prior administration of rabeprazole 20 mg Twice per day (BID) (with meals) on Days -3, -2 and -1.
15795555|NCT04488016|Drug|Treatment A-Part 2|Subjects will receive 100 mg acalabrutinib tablet (Variant 1), fasted state
15795556|NCT04488016|Drug|Treatment B - Part 2|Subjects will receive 100 mg acalabrutinib tablet (Variant 2), fasted state
15795557|NCT04488016|Drug|Treatment C - Part 2|Subjects will receive 100 mg acalabrutinib tablet (Variant 3), fasted state
15795558|NCT04488016|Drug|Treatment D - Part 2|Subjects will receive 100 mg acalabrutinib solution, (Variant 4), fasted state
15795559|NCT04488003|Drug|Ulixertinib|Oral, 600 mg, twice daily, for 28-days in each treatment cycle
15795560|NCT04488003|Drug|Physician's Choice|Physician's choice will be restricted to two approved (not off-label) treatments for each tumor histology (agents targeting BRAF or MEK kinases and experimental agents are not permitted as physician choice)).
15795561|NCT04487990|Drug|unfractionated Heparin|Addition of unfractioned heparin to CVVHD system already running under citrate regional anticoagulation.
15795562|NCT04487977|Other|Survey|Answering a survey on airway management in COVID-19 patients
15795563|NCT04487964|Dietary Supplement|Licorice extract|"LICORICE CAPSULES; 250 mg standardized extract (25% Glycyrrhizin - 62.5 mg) For 10 days, with measuring blood pressure daily.
~Dose:
~One capsule, twice daily, before meals. Boswellia serrata Gum Resin; B. serrate contains volatile oils (5-15%), pure resin (55-66%), and mucus (12-23%). The resin contains terpenoids, phenolic compounds, flavonoids, and phenylpropanoids. More than 12 different Boswellic acids have been identified, the amounts of 11-keto-β-boswellic acid KBA is 3-4.7% and acetyl-11-keto-β-boswellic acid(AKBA) is 2.2-2.9%, Dose: 2 gm, 4 times daily For 15 days, Boswellia Gum Resin is administered by chewing for a half-hour"
15795564|NCT04487951|Other|Pro BNP , Vitamin D|This study is designed to assess the difference between level of NT-pro-BNP, and Vitamin D in moderate cases who progressed to severe or critically ill category compared to those who did not.
15795565|NCT04487938|Other|No intervention utilised|No intervention utilised
15795566|NCT04487925|Procedure|Modified natural cycle|Patients will receive up to three modified natural cycles instead of conventional ovarian hyperstimulation
15795567|NCT04487912|Drug|Tilmanocept|Combined peri-areolar and peri-tumoral injection of 99m-Tc Tilmanocept
15795568|NCT04487912|Drug|Nanocolloid|Combined peri-areolar and peri-tumoral injection of 99m-Tc Nanocolloid
15795658|NCT04487080|Drug|Placebo|Participants will receive matching placebo orally.
15795659|NCT04487067|Drug|Atezolizumab|Atezolizumab 1200 mg IV infusion q3w
15795569|NCT04487899|Device|Analysis of heart rate variability|The HR HRV interval of the heartbeat (variations in the time interval between beats) was used as a measure of autonomous modulation, and the Firstbeat Bodyguard monitor (Firstbeat Technologies, Jyväskylä, Finland) was used to record HRV data for 15 minutes in rest and for one hour in the intervention in the flight simulator. Data was downloaded from the devices to a computer using Firstbeat Uploader software (Firstbeat Technologies), and all R-R interval series were imported into the Kubios software package (University of Eastern Finland, Kuopio, Finland). To calculate the autonomous equilibrium, the commonly used HRV method based on the Poincaré graph was used (Brennan et al., 2001; Mourot et al., 2004).
15795570|NCT04487886|Drug|Duvelisib|Duvelisib will be taken orally at an initial dose of 25 milligrams (mg) twice per day for 14 days. The dose will be de-escalated to 15 mg, twice per day, under certain clinical circumstances.
15795571|NCT04487886|Drug|Placebo|A placebo to match duvelisib will be taken orally twice per day for 14 days.
15795572|NCT04487860|Drug|AS012|oral administration
15795573|NCT04487860|Drug|Placebo|oral administration
15795575|NCT04487834|Drug|Simethicone Solution|Oral daily treatment for four weeks
15795576|NCT04487834|Dietary Supplement|Multilac Baby|Oral daily treatment for four weeks
15795577|NCT04487821|Other|Cawthorne Cooksey Exercises|"Activity sitting on the Exercise Ball swing (eye movements, first slow and then fast)
~Swing sitting activity (head movements, first slow then fast - eyes open and eyes closed)
~Trunk activities focusing on balance
~Dynamic balance activity focusing on standing"
15795578|NCT04487808|Drug|Pecan|Unsalted raw pecans incorporated in snack and meal recipes as part of a dietary pattern
15795579|NCT04487808|Other|Average American Diet devoid of nuts|Diet mimicking usual American intake
15795580|NCT04487782|Other|Focus Groups|The investigators are enrolling up to 56 women (total) to participate in semi-structured focus groups of 6-8 women per group conducted either in-person or virtually (online) to help us tailor a lifestyle intervention for midlife women during perimenopause.
15795581|NCT04487756|Drug|Atezolizumab 1200 mg in 20 ML Injection|"- Induction (4 cycles, every 3 weeks): Atezolizumab, 1200 mg administered intravenously every 3 weeks on day 1 of each cycle)
~- Maintenance (only patients without PD after 4 induction cycles, up to PD): Atezolizumab iv (1200 mg/IV on day 1 every 3 weeks)"
15795582|NCT04487756|Biological|ADC Vaccine|- Maintenance (only patients without PD after 4 induction cycles, up to PD): DCV intradermally (max. 6 doses) on weeks 1, 3, 6, 9, 21, 33.
15795583|NCT04487756|Drug|Carboplatin|- Induction (4 cycles, every 3 weeks): Carboplatin AUC 5 (5 mg per milliliter per minute, administered intravenously on day 1 of each cycle) and etoposide (100 mg per square meter of body-surface area, administered intravenously on days 1 through 3 of each cycle)
15795584|NCT04487743|Drug|Liraglutide|Randomization was performed with the use of a computer-generated system provided by the sponsor. Eligible patients were randomly assigned, in a 2:1 ratio, to receive once-daily subcutaneous injections of liraglutide, starting at a dose of 0.6 mg with weekly 0.6-mg increments to 3.0 mg, or placebo; both groups received counseling on lifestyle modification
15795585|NCT04487743|Drug|placebo|Randomization was performed with the use of a computer-generated system provided by the sponsor. Eligible patients were randomly assigned, in a 2:1 ratio, to receive once-daily subcutaneous injections of liraglutide, starting at a dose of 0.6 mg with weekly 0.6-mg increments to 3.0 mg, or placebo; both groups received counseling on lifestyle modification
15795586|NCT04487730|Behavioral|"Engage & Connect Psychotherapy"|9-weeks of weekly psychotherapy sessions focused on social reward exposure
15795587|NCT04487730|Behavioral|Symptom Review and Psychoeducation (SRP)|9-weeks of weekly psychotherapy sessions focused on symptom review and psychoeducation about depression and aging
15795588|NCT04487704|Other|camrelizumab|camrelizumab 200 mg, intravenous infusion (no need for prophylactic administration), no less than 30 min ，No more than 60 min, Q2W, one cycle every 2 weeks (14 days) or Q3W, one cycle every 3 weeks (21 days). Try to complete the administration before the ECG
15795589|NCT04487691|Biological|Nebulized Platelet Lysate|Approximately 520 cc of autologous venous blood (within AABB guideline limits) will be drawn and platelet lysate (PL), maximizing the patients baseline platelet levels (~2-4x baseline) will be produced in a clean room setting using the Regenexx, LLC proprietary lab protocols (PL-M) utilizing a double lysis technique. From that sample, a high growth factor lysate will be created using a double lysis technique, and a sample will be retained to quantify the protein profile of the PL via ELISA quantitative analysis. The PL will be aliquoted into 56 (n=28x2) 2-ml ampules using sterile technique which will then be frozen at -20°C. The patient will unfreeze each ampule and place it into a handheld ultrasonic nebulizer and inhale the platelet lysate following the nebulizer manufacture's protocol until the treatment is completed. The treatment will be applied once a day for 8-weeks.
15795590|NCT04487691|Other|Nebulized Sterile Saline|Approximately 520 cc of autologous venous blood (within AABB guideline limits) will be drawn and donated for research purposes to keep patient blinded to group allocation. Sterile normal saline to mimic the appearance of the platelet lysate will be aliquoted into 56 (n=28x2) 2-ml ampules using sterile technique which will then be frozen at -20°C. The patient will unfreeze each ampule and place it into a handheld ultrasonic nebulizer and inhale the sterile saline following the nebulizer manufacture's protocol until the treatment is completed. The treatment will be applied once a day for 8-weeks.
15795591|NCT04487678|Dietary Supplement|Ketone ester supplement|Participants taking part in this study will receive a drink containing either 141 or 282 mg/kg bodyweight of ketone esters in a randomised order. These doses are in line with recommendations by the company HVMN from which the supplements for this study will be obtained.
15795592|NCT04487652|Other|Gingival recession coverage|The Modified Coronally Advanced Tunnel technique in conjunction with a palatal subepithelial connective tissue graft will be performed.
15795593|NCT04487652|Drug|with CoQ10 spray application|After surgical recession coverage a CoQ10 spray will be applied during the early phase of wound healing.
15795594|NCT04487652|Drug|with placebo spray application|After surgical recession coverage a placebo spray will be applied during the early phase of wound healing.
15795595|NCT04487639|Diagnostic Test|SARS-CoV-2 research in nasopharyngeal swab, sperm and serologics|a nasopharyngeal swab for SARS-CoV-2 research by RT- qPCR will be performed on the day of semen collection. On the same day, serological tests will be carried out, and 30 to 50 days after, according to HAS specifications with methods validated by the National Reference Center
15795596|NCT04487626|Device|AI|After taking standard bowel preparation regimen, patients receive colonoscopy under the AI system device. During the withdrawal phase, bowel preparation quality is assessed by AI-associated scoring system. The withdrawal time is targeted at least 6min. Every detected polyp will be removed and obtained for pathological assessment.
15795597|NCT04487613|Drug|Moringa oleifera leaf|450 mg capsule
15795598|NCT04487613|Drug|Placebo|placebo capsule
15795599|NCT04487600|Other|Active voiding trial|
15795600|NCT04487587|Drug|Cediranib, Olaparib|Cediranib film coated tablet, Olaparib film coated tablet
15795601|NCT04487574|Drug|XC221|Participants will receive XC221 100 mg 2 times a day during 14 days
15795602|NCT04487574|Drug|Placebo|Participants will receive Placebo 2 times a day during 14 days
15795603|NCT04487561|Device|hemopatch|The patient will be randomized after performing the lymphadenectomy, according to a table of random numbers performed in excel kuytools, then a compression bandage will be performed on all the patients and it will be controlled 24 hours postoperatively, the subsequent control will be weekly until the drain is removed. and / or the disappearance of the seroma
15795604|NCT04487561|Procedure|Aspirative drainage|The patient will be randomized after performing the lymphadenectomy, according to a table of random numbers performed in excel kuytools, then a compression bandage will be performed on all the patients and it will be controlled 24 hours postoperatively, the subsequent control will be weekly until the drain is removed. and / or the disappearance of the seroma
15795606|NCT04487535|Other|Cytokine level|Serum cytokine level will be measured before surgery, 72nd after surgery and 6 weeks after surgery
15795607|NCT04487522|Procedure|Open retromuscular ventral hernia repair|With the subject under general anesthesia, a single incision is made in the abdomen. The retrorectus space is developed for mesh placement to repair the defect. The repair technique will be per the surgeon's standard of care.
15795608|NCT04487522|Procedure|Laparoscopic retromuscular ventral hernia repair|With the subject under general anesthesia, several small incisions are made in the abdomen. Ports are placed, the abdomen is insufflated, and laparoscopic instruments as well as a laparoscope are inserted to complete the repair. The retrorectus space is developed for mesh placement to repair the defect. The repair technique will be per the surgeon's standard of care.
15795609|NCT04487522|Device|Robotic-assisted retromuscular ventral hernia repair|With the patient under general anesthesia, several small incisions are made in the abdomen. Ports are placed, the abdomen is insufflated, and the da Vinci Robotic Surgical System (Intuitive) is docked to the subject and used to complete the procedure. The retrorectus space is developed for mesh placement to repair the defect. The repair technique will be per the surgeon's standard of care.
15795610|NCT04487509|Other|THROMBOLYSE|the treatment delivered to the emergency room, in particular the nature of the treatment for obstruction (primary angioplasty or thrombolysis)
15795611|NCT04487483|Behavioral|Sleep App|A sleep app offering 6 evidence based techniques to improve sleep (such as Cognitive Behavioural Therapy for Insomnia, Progressive Muscle Relaxation and Mindfulness Meditation), allowing for a personally tailored journey of sleep aids within the app.
15795612|NCT04487470|Other|Flavored filtered cigars|Flavored and unflavored Cheyenne filtered cigars that are currently available in the marketplace for purchase
15795613|NCT04487470|Other|Unflavored filtered cigars|Flavored and unflavored Cheyenne filtered cigars that are currently available in the marketplace for purchase
15795614|NCT04487457|Other|Blood samples|Blood samples
15795615|NCT04487444|Drug|Thymalfasin|Synthetic 28 amino acid peptide identical to naturally circulating compound
15795616|NCT04487431|Drug|BAY1817080|Oral single dose
15795617|NCT04487431|Drug|[14C]BAY1817080|Oral single dose
15795618|NCT04487418|Procedure|Electro cautery surgery|"Pre-anesthetics with therapeutic topic (benzocaine) will be administered and, as an anesthetic, or use of anesthetic drops (benzocaine or tetracaine) or local infiltrative anesthesia (2% lidocaine 1: 100,000 with adrenaline).
~The surgery will be carried out with cauterization for incision of the lingual brake, division of the brake fibers and release, removing the brake fibers that are stored in the anterior ventral free parts of the tongue until reaching the base of the tongue, which are removed or cleaned, lingual movement, and the anterior axis of the tongue is repositioned or lingual brake in that region. No sutures will be performed and should be oriented on the formation of a pseudo-membranous repair plate in the second intention that will be formed between the first and the third day after surgery.
~Postoperative care:
~Guidance will be given to the person responsible for not bringing objects to the mouth that may hurt."
15795619|NCT04487418|Procedure|High power diode laser surgery|"Pre-anesthetics with therapeutic topic (benzocaine) and as anesthetic or use of anesthetic eye drops (benzocaine or tetracaine) or local infiltrative anesthesia (2% lidocaine 1: 100,000 with adrenaline) will be administered. The surgery will be performed with a high power diode laser (TW Surgical, MMOptics - São Carlos - Brazil). 808 nm wavelength, which can be operated in continuous or interrupted mode. Wattages from 1 to 1.5 W, up to a maximum of 2 W, can be used and must carefully respect the histological characteristics of the target tissue and the signs of overheating and carbonization, so that the choice of parameters is dynamic and very dependent on experience, mastery and care for the operator.
~Preoperative care: Guidance will be given to the person responsible for not bringing objects to the mouth that may hurt."
15795620|NCT04487405|Device|OVAnex|OVAnex is a multivarite index assay assessing ovarian cancer risk
15795621|NCT04487392|Drug|Estrogen vaginal cream group (group A)|The participants selected for group A will be provided with estriol 0.01% vaginal cream, which should be applied at home: 1 intravaginal applicator at night, daily for 2 weeks, followed by 2 times a week, on alternate days (Monday - Thursday) for another 2 weeks.
15795653|NCT04487093|Drug|neoantigen vaccine + EGFR-TKI|"Patients received subcutaneous injection of individualized neoantigen peptides vaccine at a dose of 200ug per peptide once a week for 5 weeks.
~The targeted drugs are used continuously according to the instructions and dosage until disease progression or intolerance."
15795660|NCT04487067|Drug|Bevacizumab|Bevacizumab 15 mg/kg IV Q3W
15795622|NCT04487392|Radiation|Photobiomodutation group (group B)|The participants selected for group B will be undergo photobiomodulation with red LED. With the participant in the lithotomy position, the speculum will be introduced into the vaginal canal and a vaginal wash with 0.9% saline will be performed to remove secretions. Afterwards, the speculum will be removed and the device with a red LED inserted up to about 6 cm from the introitus. A non-lubricated condom will be used in the LED device for patient protection. Sessions will take place once a week for 4 weeks.
15795623|NCT04487366|Other|reaching targeted area on the phantom model|resident reach the targeted area on the phantom model using ultrasoun guidance and independently or with asistance inject the solution
15795624|NCT04487353|Other|Application of computer aided virtual reality glasses|"In the second stage: No application will be made to the control group, computer-aided and guided virtual reality application will be applied to the experimental group, and computer-free and non-guided virtual application will be monitored to the experimental group II.
~In the third stage: DEDBF questions will be replaced and posttests will be applied. After the 4-hour theory training for the control group, the post-test will be done after the virtual birth application is watched on the experiment groups. Also, at this stage, Cognitive Load Scale and Feel of Inventory will be applied to the experimental groups after the application.
~In the fourth stage: After three weeks, the DEDBF will be applied again to the three groups, and the effectiveness of the application of virtual birth will be examined in recalling and recalling the information."
15795625|NCT04487340|Behavioral|Education|Provide each center with relevant education of guidelines, and help the clinicians to improve medical quality.
15795626|NCT04487327|Other|Dry Needling|"The dry-needling treatment will consist of inserting a sterile needle into 2-4 muscles of the participant either at the MTrP or 2 cm away from the MTrP, but within the same muscle. To assist in the reduction of infection risk and protection of the participants, the site will be cleaned with alcohol prior to treatment and investigators performing the needling treatment will wear gloves and handle needles using aseptic technique throughout the procedure. Each needle insertion will last approximately 5 seconds using a pistoning (in and out) technique."
15795627|NCT04487288|Diagnostic Test|SONAZOID|CEUS using SONAZOID with fusion technique
15795628|NCT04487275|Drug|MLC901 or Placebo|groups randomly assigned to receive either MLC901 or placebo capsules three times per day over 6 months
15795629|NCT04487262|Procedure|Cardiac surgery|Elective open heart surgery
15795630|NCT04487249|Other|Vision Therapy|20 consecutive weeks of office-based vision therapy with home therapy that aim to improve the participant's vergence skills, accommodative skills, and sensory fusion.
15795631|NCT04487236|Drug|ZN-A-1041 50mg BID|Orally 21days for one cycle
15795632|NCT04487236|Drug|ZN-A-1041 100mg BID|Orally 21days for one cycle
15795633|NCT04487236|Drug|ZN-A-1041 200mg BID|Orally 21days for one cycle
15795634|NCT04487236|Drug|ZN-A-1041 400mg BID|Orally 21days for one cycle
15795635|NCT04487236|Drug|ZN-A-1041 600mg BID|Orally 21days for one cycle
15795636|NCT04487236|Drug|ZN-A-1041 800mg BID|Orally 21days for one cycle
15795637|NCT04487236|Drug|ZN-A-1041 1000mg BID|Orally 21days for one cycle
15795638|NCT04487236|Drug|ZN-A-1041 Level 1 +Capecitabine|ZN-A-1041 level 1 BID; Capecitabine 1000 mg/m2 BID
15795639|NCT04487236|Drug|ZN-A-1041 Level 2 +Capecitabine|ZN-A-1041 level 2 BID; Capecitabine 1000 mg/m2 BID
15795640|NCT04487236|Drug|ZN-A-1041 Level 3 +Capecitabine|ZN-A-1041 (RP2D level) BID; Capecitabine (RP2D level) BID
15795641|NCT04487210|Biological|MVC-COV1901|MVC-COV1901 is formulated in the different dosages of Spike (S) protein with CpG 1018 and aluminum content as adjuvant.
15795642|NCT04487197|Procedure|blood sample for seroepidemiological investigation|blood sample for seroepidemiological investigation
15795643|NCT04487184|Other|Kinesiology taping|Recently, kinesiology tape is a common intervention in clinic and sport. The tension caused by tape elasticity and attachment techniques affects the effects that kinesiology tape produces, such as pain relief, circulation increase, proprioception enhancement, and muscle contraction improvement.
15795644|NCT04487171|Other|Questionnaire|The mothers were administrated three questionnaires, (i) the Edinburgh Postnatal Depression Scale (EPDS), (ii) the State-Trait Anxiety Inventory (STAI-YA), and (iii) the Mother-to-Infant Bonding Scale (MIBS) in two stages, on days 2-3 after delivery and during a phone call between days 25-35.
15795645|NCT04487158|Behavioral|Small Changes|The Small Changes program is an evidence-based 6-month weight-management program. The program runs weekly for 3 months followed by by-weekly contact for 3-months (1x in-person group and 1x phone call). This program uses behaviour change strategies to help with weight loss. The Small Changes approach is different from traditional dieting programs because it encourages modest changes to diet and physical activity which are not overly taxing to maintain. Participants are asked to reduce their nutritional intake by 200-400 calories per day. You will also be asked to increase their daily step count by 2000-3000 steps. Weekly intervention topics include: Monitoring, Nutrition, Physical Activity, Breaking the Chain, External Cues, Mindful Eating, Body Image, Stress, Sleep, Social Support, Social Eating, and the Stoplight Guide.
15795646|NCT04487158|Behavioral|INSPIRE|The INSPIRE program is a modification to the Small Changes program. It combines elements of positive psychology and behaviour change to help with weight loss. The first four weeks of the program are oriented towards improving well-being and include topics such as values, self-compassion/mindfulness, character strengths, and gratitude. The remaining 8 weeks mirrors the Small Changes program in making modest changes to diet and physical activity to achieve weight loss. Participants are asked to reduce their nutritional intake by 200-400 calories per day. Participants will also be asked to increase their daily step count by 2000-3000 steps.
15795647|NCT04487145|Drug|Dihydroartemisinin-piperaquine|It is expected that efavirenz (EFV), lopinavir/ritonavir (LPV/r), and/or dolutegravir (DTG) will alter DP exposure.
15795648|NCT04487132|Behavioral|Active physical education lessons and physical education plan|Active physical education lessons and physical education plan Including importance of physical activity and health, and physical education plan; through lecture in classroom will be provided to the contyrolled group.
15795649|NCT04487132|Behavioral|Recess or lunch time activities|group intervention will be provided ti the experimental group which includes Preparing the playground by offering adequate spaces and games.Developing games and teaching children to play in recess time at-least 10-15 minutes daily(i.e.sport games, traditional games) Placing a sheet in the classroom with some reminders about being active in recess time (i.e. using a poster board encouraging playing one of the selected games )
15795661|NCT04487054|Other|Pro-active palliative care|Patient with high risk of mortality in ICU will be identified using our previously validated prognostic model. Intervention phase will employ pro-active palliative care on eligible patients after they survive 48 hours in ICU.
15795662|NCT04487041|Biological|Standard dose influenza vaccination|Single 0.5 ml injection administered intramuscularly into participant's deltoid muscle
15795663|NCT04487041|Biological|High dose influenza vaccination|4 times more concentrated single 0.5 ml injection administered intramuscularly into participant's deltoid muscle
15795664|NCT04487028|Procedure|Fiberoptic Endoscopic Evaluation of Swallowing|This procedure involves inserting a flexible laryngoscope that contains a light source and video camera on the end through the open passage of the nose towards the back of the throat in order to visualize the swallowing mechanism.
15795665|NCT04487015|Behavioral|MP|The app-based menu planner (MP) given to the participants has an automated carbohydrate periodisation menu planning tool, an educational and motivational nutrition content (infographics, video and text articles), and recipes. Participants using the app will input their training schedule into the app to produce their own menu plans. The behaviour change techniques (BCT) underlying the intervention are goal & planning, feedback & monitoring, shaping knowledge, natural consequences, comparison of behaviour, comparison of outcome, associations, repetitions, reward & threat, regulation and antecedents.
15795666|NCT04487015|Behavioral|Call|A 30-45 minutes coaching consultation telephone/Skype call from the nutrition coaching to give social support. The BCT underlying the intervention is goal & planning, social support, natural consequences.
15795667|NCT04487015|Behavioral|MesC|Nutrition coach-led messaging (MesC) is where the mobile app (MP) has the text messaging feature activated, and the nutrition coach proactively initiates a conversation via text messaging up to three times a week to offer nutrition support to the participant. The BCT underlying the intervention is goal & planning, social support, natural consequences.
15795668|NCT04487002|Procedure|surgical resection|
15795669|NCT04486989|Behavioral|Cardiovascular Conditioning Protocol|Participants will be randomized to either one of the treatment arms to receive treatment for a period of 4 weeks.
15795670|NCT04486989|Other|Voice Production Exercises|Participants will be randomized to either one of the treatment arms to receive treatment for a period of 4 weeks.
15795671|NCT04486976|Device|Cornea/Anterior Segment OCT CASIA2|Cornea/Anterior Segment OCT CASIA2 The Tomey Cornea/Anterior Segment OCT CASIA2 is a non-contact, high resolution tomographic and biomicroscopic device indicated for the in vivo imaging and measurement of ocular structures in the anterior segment, such as corneal thickness. The Tomey Cornea/Anterior Segment OCT CASIA2 is indicated as an aid in the visualization of anterior segment findings.
15795672|NCT04486976|Device|Optovue RTVue XR Avanti|Optovue RTVue XR Avanti The Avanti is an optical coherence tomography system indicated for the in vivo imaging,axial cross-sectional, and three-dimensional imaging and measurement of anterior and posterior ocular structures.
15795673|NCT04486963|Drug|Sanhuangjingshimingwan|Sanhuangjingshimingwan,12g,Bid,6 months.Anti VEGF injection will be injected monthly if needed.
15795674|NCT04486963|Drug|Sanhuangjingshimingwan Placebo|Sanhuangjingshimingwan Placebo,12g,Bid,6 months.Anti VEGF injection will be injected monthly if needed.
15795675|NCT04486950|Drug|TAK-951|TAK-951 intravenous infusion.
15795676|NCT04486950|Drug|TAK-951 Placebo|TAK-951 placebo-matching intravenous infusion.
15795677|NCT04486937|Drug|S410914 tablet|S410914 tablet
15795678|NCT04486924|Device|Globe Mapping and Ablation System|Prospective, non-randomized, open-label clinical study.
15795679|NCT04486911|Drug|Pyrotinib maleate, SHR6390, letrozole|After providing written informed consent, the participants will undergo combined treatment of pyrotinib maleate, CDK4/6 inhibitor SHR6390, and letrozole. The effectiveness of the combined treatment will be evaluated by MRI every two treatment cycles. If the disease progresses, the participant will withdraw from the trial. If the combined treatment has identified effectiveness, the participant will undergo surgical treatment within 4 weeks (over 2 weeks) after termination of the neoadjuvant treatment. The patients will be followed up for 5 years.
15795680|NCT04486898|Other|Music group|Music group will be given music intervention or listen to music for 30 minutes ,3 times a week for the period of 5 week duration. Music will be selected as per participant's preference
15795681|NCT04486872|Biological|Autologous humanized anti-CD19 and anti-CD20 dual specific CAR-T Cells|Autologous Humanized Anti-CD19 and Anti-CD20 Dual Specific CAR-T Cells injection. Within 3 to 5 days after the pretreatment, the subjects received a single A-02 reinfusion, the infusion dose of each group of subjects 1.00 × 10^6/kg, 3.00 × 10^6/kg or 5.00 × 10^6/kg (if applicable), it is recommended to complete the infusion within 30 min after cell recovery.
15795684|NCT04486846|Other|eVisit|electronic surveillance program in lieu of in-person clinic visit
15795685|NCT04486833|Biological|Quaratusugene ozeplasmid - intravenous infusion|Quaratusugene ozeplasmid is an experimental nonviral immunogene therapy utilizing the TUSC2 gene, designed to target cancer cells by interrupting cell signaling pathways that allow cancer cells to grow, re-establishing pathways that promote cancer cell death and modulating the immune response against cancer cells.
15795686|NCT04486833|Drug|Osimertinib Oral Tablet|Osimertinib is a 3rd generation EGFR tyrosine kinase inhibitor (TKI) oral tablet administered daily, as indicated for treatment of patients with metastatic NSCLC whose tumors have EGFR genetic deletions or mutations.
15795687|NCT04486820|Other|Analysis Immunohistochemical|Analysis of histological material for immunohistochemical study. To explore PD-L1, CD8, CDX2, INSM1 and FOXA1 expression
15795688|NCT04486807|Diagnostic Test|Elite badminton players|The population was all the elite badminton players followed in a University Hospital Centre and the National Institute of Sport, Expertise, and Performance. We excluded players who had SSI in the 3 months prior to the isokinetic test or had shoulder surgery. They were included and followed during the badminton season (Nineteen elite badminton players and followed over the badminton season (from september 2018 to may 2019 or from september 2019 to may 2020)
15795689|NCT04486794|Device|Restylane®|Hyaluronic acid
15795690|NCT04486781|Drug|Pembrolizumab + sEphB4-HSA|sEphB-HSA may prevent tumor cells from multiplying and blocks several compounds that promote the growth of blood vessels that bring nutrients to the tumor.
15795795|NCT04485884|Drug|IN-C005 dose F|Oral administration of IN-C005 dose F once daily for 7 days.
15795691|NCT04486768|Other|Survey Instrument|This registry contains several surveys that will be released for patient/caregiver completion at enrollment and at time points following enrollment. These surveys can be completed on any computer that is connect to the internet.
15795692|NCT04486755|Radiation|Hypofractionated Radiation Therapy|All patients RT will be delivered utilizing pencil beam scanning proton therapy. Radiation treatment will be delivered 4 days per week.
15795693|NCT04486742|Behavioral|Itch CBT|Telemedicine CBT sessions with a therapist to address atopic dermatitis related concerns.
15795694|NCT04486729|Other|High PEEP with end inspiratory pause|Applying a PEEP value 10 cmH2O higher than the lower inflection point of the pressure-volume curve of the respiratory system with end inspiratory pause addition in volumen control ventilation
15795695|NCT04486729|Other|Low PEEP - FiO2 high|Applying a PEEP value equal to the lower inflection point of the pressure-volume curve of the respiratory system with a FiO2 necessary to achieve a SpO2 96-98%
15795696|NCT04486729|Other|High PEEP without end inspiratory pause|Applying a PEEP value 10 cmH2O higher than the lower inflection point of the pressure-volume curve of the respiratory system without end inspiratory pause addition in volumen control ventilation
15795697|NCT04486729|Other|Low PEEP - FiO2 low|Applying a PEEP value equal to the lower inflection point of the pressure-volume curve of the respiratory system with a FiO2 necessary to achieve a SpO2 88-92%
15795698|NCT04486716|Drug|Ofatumumab|Investigational drug will be provided in an autoinjector for subcutaneous administration containing 20 mg ofatumumab (20 mg/0.4 ml)
15795699|NCT04486703|Other|Exercise with music|physical therapy program combined with music therapy 15 min, 3 times weekly for 12 weeks.
15795700|NCT04486690|Drug|Ketofol (propofol to ketamine ratio 1:1)|"Ketofol 25-150 mic/kg/min with propofol to ketamine ratio 1:1.
~Fentanyl infusion, 1-2 mcg/kg/h.
~Atracurium infusion, 3-12 mic/kg/min"
15795701|NCT04486690|Drug|propofol|"Propofol infusion, 25-150 mcg/kg/min.
~Fentanyl infusion, 1-2 mcg/kg/h.
~Atracurium infusion, 3-12 mic/kg/min."
15795704|NCT04486664|Behavioral|Mediterranean Diet|Diet instruction and menu samples from the dietitian on following the Mediterranean Diet.
15795705|NCT04486651|Drug|Irinotecan Hydrochloride Injection|160 mg/m² administered as IV infusion on Day 1 of each 14-day cycle.
15795706|NCT04486651|Drug|HX008|200 mg administered as IV infusion on Day 1 of each 21-day cycle.
15795707|NCT04486651|Drug|Placebo|Administered as IV infusion on Day 1 of each 21-day cycle.
15795708|NCT04486638|Biological|Dengue Tetravalent Vaccine, Live|Pharmaceutical form: Powder and solvent for suspension for injection Route of administration: Subcutaneous
15795709|NCT04486625|Drug|Aztreonam-Avibactam|500/167 mg ATM/AVI loading infusion, followed by 1500/500 mg ATM/AVI extended loading infusion, then 1500/500 mg ATM/AVI maintenance dose infusion every 6 hours
15795710|NCT04486625|Drug|Aztreonam-Avibactam|675/225 mg ATM/AVI loading infusion, followed by 675/225 mg ATM/AVI extended loading infusion, then 675/225 mg ATM/AVI maintenance dose infusion every 8 hours
15795711|NCT04486612|Other|spinal anesthesia|prospective observational study
15795712|NCT04486599|Device|Electromagnetic Navigation|The echo-guided sclerotherapy procedure, assisted by electromagnetic navigation, will be carried out in a clean room during the day hospitalisation and followed by a control Echo-Doppler carried out 2 hours after the procedure.
15795713|NCT04486586|Device|Active tDCS plus Speech-Language Therapy|Stimulation will be delivered by a battery-driven constant current stimulator. The electrical current will be administered to a pre-specified region of the brain (inferior frontal gyrus). The stimulation will be delivered at an intensity of 2 mA (estimated current density 0.04 mA/cm^2; estimated total charge 0.048 C/cm^2) in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy will target apraxia of speech (AOS).
15795714|NCT04486586|Device|Sham plus Speech-Language Therapy|Speech-language therapy will be administered during sham stimulation. Current will be administered in a ramp-line fashion but after the ramping the intensity will drop to 0 mA. Speech-language therapy will target apraxia of speech (AOS).
15795715|NCT04486573|Diagnostic Test|Cardiac Magnetic Resonance Imaging|A cardiac MRI is a painless imaging test that uses radiowaves, magnets, and a computer to create detailed pictures of the heart.
15795716|NCT04486560|Device|ERBECRYO® 2 Cryosurgical Unit and Accessories - K190651|ERBE 1.1mm flexible single-use cryoprobe with oversheath
15795717|NCT04486547|Behavioral|Information-Motivation-Behavioral Skills model-based intervention|Home visits were made to the study group and nursing interventions were administered in accordance with the components of the Information-Motivation-Behavioral Skills model
15795718|NCT04486534|Other|Musculoskeletal ultrasound|Subjects' talar cartilage, tibialis anterior and gastrocnemius muscle thickness measurements will be performed using musculoskeletal ultrasound.
15795719|NCT04486521|Drug|Interleukin 6 (IL6) Antagonist|anti-IL6 alone
15795720|NCT04486521|Drug|Interleukin 6 (IL6) Antagonist and corticosteroids|anti-IL6 + corticosteroid combination
15795721|NCT04486521|Drug|corticosteroid alone|"dexamethasone, hydrocortisone, methylprednisolone, prednisone. All steroids  other than dexamethasone will be converted to dexamethasone equivalent"
15795722|NCT04486508|Drug|intermediate dose Enoxaparin/ unfractionated heparin|Intermediate dose anticoagulation according to creatinine clearance and weight
15795723|NCT04486508|Drug|standard prophylactic dose Enoxaparin/ unfractionated heparin|Standard prophylaxis anticoagulation according to creatinine clearance and weight
15795724|NCT04486508|Drug|Atorvastatin 20mg|Statin
15795725|NCT04486508|Drug|Matched placebo|Matched placebo to atorvastatin 20 mg
15795726|NCT04486482|Other|KB109 + Self Supportive Care (SSC)|KB109 is a novel glycan
15795727|NCT04486482|Other|Self Supportive Care (SSC) Alone|Self Supportive Care (SSC) Alone
15795796|NCT04485871|Dietary Supplement|Omega-3 fatty acids|Tripple Strength Omega-3 from Webber Naturals; 4 oral softgels (600 mg EPA and 300 mg DHA / softgel)
15795798|NCT04485845|Drug|Vildagliptin|to compare the effect of both metformin and vildagliptin on the progression of diabetes and metabolic complications and risk factors
15795728|NCT04486469|Other|Physical Therapy Group|"Performing direct physical treatment on the diaphragm, using stretching, followed by teaching exercises for re-education of the abdomen and diaphragm.
~Transcutaneous retrograde electrostimulation: L1-L4 (2hz-10hz) rectangular asymmetric biphasic at the level of the dermatome. From the anterior inferior iliac spine to a pubic symphysis. Second canal from the greater trochanter to the saphenous veins. (30 min). Parameters of this program: 2 Hz and 180ms.
~Connective Tissue Massage or Dicke
~Massage with direct maneuvers on the abdomen: The direction of the maneuvers will be clockwise. We will perform 6 very slow strokes adding small pressures on the ascending, transverse and descending colon respectively and repeating this maneuver 3 times. (10 minutes)"
15795729|NCT04486443|Behavioral|music therapy|patients in the intervention group received music therapy in 10-minutes sessions with the support of a specialist from the Conservatory Department in the Ege University, using the Turkish classical music (Hejaz and Rast modes) accompanied by a tambour.
15795730|NCT04486430|Drug|Neu2000KWL|1st infusion of 500mg in patients within 6 hours following ischemic stroke onset followed by 9 consecutive infusions of 250 mg at intervals of 12 hours
15795731|NCT04486430|Drug|Neu2000KWL|1st infusion of 750mg in patients within 6 hours following ischemic stroke onset followed by 9 consecutive infusions of 500 mg at intervals of 12 hours
15795732|NCT04486430|Drug|Neu2000KWL|1st infusion of 1500mg in patients within 6 hours following ischemic stroke onset followed by 9 consecutive infusions of 500 mg at intervals of 12 hours
15795733|NCT04486430|Drug|Placebos|1st infusion of the same volume of saline in patients within 6 hours following ischemic stroke onset followed by 9 consecutive infusions of the same volume of saline at intervals of 12 hours
15795734|NCT04486404|Other|Online survey|Online survey including questions related to PPE availability, perceptions, emotions and EASE scale (Acute Stress Scale).
15795735|NCT04486391|Drug|Tislelizumab|200 mg administered via intravenous (IV) infusion once every 3 weeks
15795736|NCT04486391|Drug|Salvage Chemotherapy|Salvage chemotherapy administered as assessed as appropriate by the investigator in accordance with the local guideline, including but not limited to DHAP (dexamethasone, cisplatin, high-dose cytarabine), ESHAP (etoposide, methylprednisolone, high-dose cytarabine and cisplatin), DICE (dexamethasone, ifosfamide, carboplatin, etoposide), ICE (ifosfamide, carboplatin, etoposide), IGEV (ifosfamide, gemcitabine, vinorelbine, prednisone), GVD (gemcitabine, vinorelbine, liposomal doxorubicin), and MINE (etoposide, ifosfamide, mesna, mitoxantrone)
15795737|NCT04486378|Drug|RO7198457 intravenous (i.v.)|RO7198457 administered as an IV infusion at protocol-specified intervals over 12 months.
15795738|NCT04486378|Other|Observational group (no intervention)|watchful waiting
15795739|NCT04486365|Procedure|Bifocal bone transport.|The bifocal approach is a single osteotomy to create one transported bone segment between the osteotomy and the defect.
15795740|NCT04486365|Procedure|Trifocal bone transport|The trifocal approach is two osteotomies creating two separate transported bone segments.
15795741|NCT04486352|Drug|Atezolizumab|Atezolizumab would be given to patients intravenously at a dosage of 1680 mg every 4 weeks on a 28-day cycle.
15795742|NCT04486352|Drug|Bevacizumab|Bevacizumab would be given to patients intravenously at a dosage of 10mg per patient kilogram every 2 weeks of the 28-day cycle.
15795743|NCT04486352|Drug|Ipatasertib|Ipatasertib will be given as an oral tablet at a dosage of 400 mg once daily for 21 days of each 28-day cycle.
15795744|NCT04486352|Drug|Talazoparib|Talazoparib will be given in an oral tablet at a dosage of 1 mg once daily for each day of the 28-day cycle.
15795745|NCT04486339|Radiation|Stereotactic Radiotherapy|Stereotactic radiotherapy targets on the pulmonary vein ostium aiming to achieve pulmonary vein electrial isolation
15795746|NCT04486326|Drug|Crofelemer|Crofelemer
15795747|NCT04486326|Drug|Placebo|placebo
15795748|NCT04486313|Drug|Nitazoxanide|Two nitazoxanide 300 mg tablets administered orally twice daily with food for 5 days
15795749|NCT04486313|Drug|Placebo|Two placebo tablets administered orally twice daily with food for 5 days
15795750|NCT04486313|Dietary Supplement|Vitamin Super B-Complex|Vitamin Super B-Complex administered orally twice daily to maintain the blind
15795751|NCT04486300|Procedure|Pneumatic reduction and Laparotomy|Pneumatic reduction is the main intervention for suitable cases and If failed a laparotomy exploration and surgical reduction is done to save life
15795752|NCT04486287|Drug|Sintilimab|"Sintilimab 200mg IV, every 3 weeks, until progressive disease (PD), intolerable toxicity, or at a maximum of 12 months.
~Before enrollment, patient should undergo Stereotactic Ablation Brachytherapy. Sintilimab shall be started no later than 4 weeks after Stereotactic Ablation Brachytherapy."
15795753|NCT04486274|Other|MOSE|After each pass, the stylet will be introduced into the needle, the material will be released onto a smear slide, and a macroscopic on-site quality evaluation (MOSE) of the specimen will be performed by the endoscopist.
15795754|NCT04486261|Other|High-intensity strength training|The high-intensity strength training protocol will consist of 2 training sessions per week. The first two weeks will be familiarisation training, where each exercise will be performed in three sets of 10 repetitions at an intensity of 15 repetitions maximum (RM). At week three each session will consist of 3 sets of each exercise corresponding to 10 RM, which will be kept for the remaining part of training intervention. The weights for each exercise will be adjusted throughout the intervention period, so the training load will correspond to 10 RM for each exercise in the entire intervention period.
15795755|NCT04486235|Behavioral|Brief waiting room pamphlet|An experiential pamphlet including brief assessment questions and recommended questions for the participant to ask their physician based on their responses. Areas covered in the pamphlet include patients' knowledge of weight status and implications of weight, confidence in physicians' abilities to treat weight, stage of change for weight-related behaviors, and comfort in discussing their weight.
15795756|NCT04486222|Device|Repeated Transcranial Magnetic Stimulation|Magstim® Super Rapid² Transcranial Magnetic Stimulation System
15795757|NCT04486209|Device|transcutaneous spinal cord stimulation|electrical stimulation of the lumbosacral spinal cord through surface electrodes
15795758|NCT04486196|Device|Medency Primo Diode Laser Device (Medency, Vicenza, Italy)|Root canals were irradiated with 980 nm diode laser coupled with optical fiber 200 µm with setting at the average power 1.2-W in pulsed mode. 10 seconds irradiation followed by 10 seconds pause, which comprised one lasting cycle.
15795759|NCT04486196|Procedure|2.5% NaOCl, %17 EDTA, Distilled water, 30-gauge, side-opening needle (Canal Clean, Biodent, South Korea),|Final conventional irrigation
15795760|NCT04486183|Other|capillary blood samples|The patient's finger was wiped with alcohol, left to dry, and the first and second blood drops were read The patient was asked to wash their hands, their finger was perforated with a strip, and the first and second blood drops were read The finger of the patient whose hands had been washed was wiped with alcohol, left to dry, and the first and second blood drops were read Venous blood was collected for blood sugar measurement 2 hours after the patient had a beverage containing 75 gr sugar for OGTT The patient was ensured to wash their hands, their finger was wiped with alcohol, and the first and second blood drop glucose values were measured and recorded
15795761|NCT04486170|Other|Education provided via a video format|The intervention group will be shown a 5 minute educational video on hypertension in the postpartum period. The patients will be shown the video on the ipad while they are in the comfort of their room and the investigator will step outside. At the conclusion of the video, the investigator will return into the patient room and provide a pamphlet with similar information that was discussed in the video for them to take home.
15795762|NCT04486157|Drug|IN-A012|The subjects will be given IN-A012 by Intravenous infusion over 30 minutes.
15795763|NCT04486157|Drug|Akynzeo 300Mg-0.5Mg Capsule|The subjects will be administrated Akynzeo by Orally with water.
15795764|NCT04486144|Other|Proprietary extract of Nerium oleander|This is a proprietary extract of Nerium oleander that is 6.25 ug per 0.5 ml of suspension. It is administered sublingually every six hours for 5 days. The daily dose is 25 ug and the 5 day dose is 125 ug.
15795765|NCT04486118|Drug|Lisinopril Pills|Tablets will be taken by oral administration daily, based on titration
15795766|NCT04486118|Drug|Benazepril Pill|Tablets will be taken by oral administration daily, based on titration
15795767|NCT04486105|Dietary Supplement|sucrose|pure sucrose in water in addition to habitual diet
15795768|NCT04486092|Drug|Valproic Acid|
15795769|NCT04486079|Dietary Supplement|Nutricia PreOp|A clear, non-carbonated lemon-flavored, iso-osmolar carbohydrate drink for preoperative surgical patients. Used in studies supporting the Enhanced Recovery After Surgery (ERAS) Society Consensus Guidelines.
15795770|NCT04486066|Behavioral|Mindfulness-Based Stress Reduction|In MBSR, participants meet for 2.5 hours per week for 8 weeks in a group format and receive instruction in mindfulness meditation according to a standardized curriculum, are given daily homework, participate in group discussions, and can ask questions.
15795771|NCT04486066|Behavioral|Cognitive Behavioral Therapy for Chronic Pain|Cognitive Behavioral Therapy (CBT) is the most widely used non-pharmacologic intervention for chronic pain and a version of CBT specifically addressing chronic pain (CBT-CP) has been developed for use in VA with Veterans. Fundamentally, CBT is an approach that seeks to ameliorate dysfunctional relationships between an individual's thoughts, feelings, and behaviors to improve functioning and quality of life. At our site, the CBT-CP format has been adapted for clinical use (i.e., as part of usual clinical care) to 8 sessions in a group format, while retaining all essential elements.
15795772|NCT04486066|Other|Usual Care|Veterans randomized to usual care will continue to be followed by their usual care providers for all medical and mental health care. This can include continued use of medications, specialty referrals and other usual elements of care. They will be asked to not enroll in the specific MBSR or CBT-CP interventions during the 8-month study period, but can attend other groups interventions, such as CBT-Insomnia, Acceptance and Commitment Therapy for Chronic Pain, and other groups for chronic pain and PTSD as directed by their treating providers. They can also enroll in MBSR or CBT-CP at the completion of the study.
15795773|NCT04486053|Other|Screening|The patients who agreed to participate to the study were assessed with a survey which included age, gender, height, weight and hand dominancy questions. Sensory, motor and functional assessments of the bilateral hand were performed.
15795774|NCT04486040|Procedure|Drainage|Use of the suction drainage after hip revision arthroplasty
15795775|NCT04486040|Procedure|No-drainage|Patients without drainage after surgery
15795776|NCT04486014|Procedure|Erector spinae plane block|Erector Spinae Group (Group E) will receive bilateral ultrasound-guided erector spinae plane block using 30 ml hyperbaric bupivacaine 0.25% will be injected between erector spinae muscle and transverse process of T4
15795777|NCT04486014|Procedure|Serratus anterior plane block|Serratus anterior Group (Group S) will undergo bilateral ultrasound-guided serratus anterior plane block with 30 ml hyperbaric bupivacaine 0.25% will be injected above or below serratus anterior muscle at the level of 4th and 5th rib on the midaxillary line
15795778|NCT04486001|Biological|PSC-04|adipose stem cells derived from screened donor lipoaspirate and culture expanded.
15795779|NCT04485988|Drug|Beta blocker|Duration of medication
15795780|NCT04485975|Device|Therapeutic plasma exchange|Therapeutic plasma exchange filtrates plasma and decreases thyroid hormone concentration in the blood
15795781|NCT04485962|Biological|Fibroblasts and keratinocytes|"Autologous cultured fibroblasts and keratinocytes
~For PR: The name  fibroblasts and keratinocytes is exactly the name of the cell product registered by our ministry of health. There is no trade or international name."
15795782|NCT04485949|Biological|IGV-001 Cell Immunotherapy|IGV-001, containing autologous GBM cells treated with antisense oligonucleotide (IMV-001), encapsulated in biodiffusion chambers.
15795783|NCT04485949|Biological|Placebo|Placebo, encapsulated in biodiffusion chambers containing a predetermined inactive solution.
15795784|NCT04485949|Procedure|Standard of Care (SOC): Radiation Therapy|Radiation therapy administered per institutional standards.
15795785|NCT04485949|Drug|SOC: Temozolomide|Temozolomide administered orally.
15795786|NCT04485936|Device|Epitomee Device|medical Device designed to enhance the feeling of early satiation and prolonged satiety
15795787|NCT04485910|Other|Single step media|Usage of single step media in embryo culture
15795788|NCT04485910|Other|Sequential media|Usage of sequential media in embryo culture
15795789|NCT04485897|Device|icare HOME device (Icare Oy, Vanda, Finland)|icare HOME device versus hospital based measurements
15795790|NCT04485884|Drug|IN-C005 dose A|One time dose of IN-C005 dose A taken orally.
15795791|NCT04485884|Drug|IN-C005 dose B|One time dose of IN-C005 dose B taken orally.
15795792|NCT04485884|Drug|IN-C005 dose C|One time dose of IN-C005 dose C taken orally.
15795793|NCT04485884|Drug|IN-C005 dose D|Oral administration of IN-C005 dose D once daily for 7 days.
15795794|NCT04485884|Drug|IN-C005 dose E|Oral administration of IN-C005 dose E once daily for 7 days.
15795799|NCT04485845|Drug|Captopril Tablets|used to treat hypertension in metabolic syndrome patients and as a renal protector
15795800|NCT04485845|Drug|MetFORMIN 500 Mg Oral Tablet|antihyperglycemic drug for elevated plasma glucose level and help in weight loss for patients suffering from diabetes or metabolic syndrome
15795801|NCT04485832|Device|Telehealth care|Patients in the intervention group daily answer 6 questions, which are focused on the recognition of AECOPD, using the electronic healthcare platform Evita by Swisscom, which has been and continuously is developed by the study team and Swisscom. The study team daily analyses all patients online and reacts according to a pre-specified action plan.
15795802|NCT04485832|Diagnostic Test|Weekly CAT measurement|
15795803|NCT04485819|Other|Cleavage stage transfer|transferring embryos through ICSI procedures for poor responders on cleavage stage of embryonic development.
15795804|NCT04485819|Other|Blast stage transfer|transferring embryos through ICSI procedures for poor responders on blast stage of embryonic development.
15795805|NCT04485806|Other|GPS/LM|Media microdroplet geometry (3D dishes) in combination with light mineral oil overlay
15795806|NCT04485806|Other|SPL/LM|Media microdroplet geometry (2D dishes) in combination with light mineral oil overlay
15795807|NCT04485806|Other|GPS/PO|Media microdroplet geometry (3D dishes) in combination with Paraffin oil overlay
15795808|NCT04485806|Other|SPL/PO|Media microdroplet geometry (2D dishes) in combination with paraffin oil overlay
15795809|NCT04485793|Dietary Supplement|Dietary supplement|"Dietary supplement formulated with components of natural origin: artichoke, bergamot, folic acid, astaxanthin and chromium picolinate. Each tablet contains: artichoke d.e. (700 mg), equivalent to 42 mg caffeoylquinic acids and 10.5 mg flavonoids; bergamot d.e. (375 mg), equivalent to 150 mg flavonoids; microalgae (Haematococcus pluvialis, 20 mg), equivalent to 0.5 mg astaxanthin; chromium picolinate (320 μg), equivalent to 40 μg chromium; and 200 μg folic acid.
~Oral administration: 1 tablet/day at evening meal"
15795810|NCT04485793|Other|Placebo|Oral administration: 1 tablet/day at evening meal
15795811|NCT04485780|Biological|botulinum toxin type A|In the outpatient department, patients who need hemorrhoidectomy were randomly assigned to two groups at a 1:1 ratio using a computer-generated list of random numbers (Microsoft Excel). One group received Botulinum toxin injection during the outpatient clinic one week before the operation(experimental group, EG), and the other group received injection during the operation(control group, CG). The two groups were compared for the influence of postoperative pain control and wound healing rate.
15795812|NCT04485767|Behavioral|Progressive Resistance Training Exercise|Progressive Resistance Training Exercise 2x weekly for 6 months.
15795813|NCT04485767|Behavioral|Flexibility and Balance Exercise|Flexibility and Balance Exercise Training Exercise 2x weekly for 6 months.
15795814|NCT04485754|Other|Telemedicine FU|Participant will get telemedicine follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.
15795815|NCT04485754|Other|Office FU|Participant will get office follow-up visit at 1, 3, and 6 months or 1 and 6 months after discharge from hospital.
15795816|NCT04485741|Device|RESP|The RESP device will be placed on the patient for periodic recording of auscultory sound.
15795817|NCT04485728|Behavioral|Sleep Improvement Protocol Intervention for Hospitalized Antepartum Patients|Patients are getting sleep hygiene education and a sleep hygiene kit.
15795818|NCT04485715|Other|AI system|The real-time assistance of AI system
15795819|NCT04485702|Drug|Midazolam injection|2mg IV
15795820|NCT04485702|Drug|Ketamine Injectable Product|6mg IV
15795821|NCT04485702|Drug|MELT-100|midazolam 3mg and ketamine 25mg SL tablet
15795822|NCT04485689|Drug|Capsaicin Topical - alone|5x7 cm2 capsaicin patch applied on the dorsal area of the hand and left in place for 24 hours
15795823|NCT04485689|Drug|Placebo - alone|5x7 cm2 patch applied on the dorsal area of the hand and left in place for 24 hours
15795824|NCT04485689|Drug|Capsaicin Topical - ice|5x7 cm2 capsaicin patch applied on the dorsal area of the hand and left in place for 24 hours. Ice will be applied on top of the patch 1.5 hrs post patch application and left in place for 1 hr.
15795825|NCT04485689|Drug|Placebo - ice|5x7 cm2 patch applied on the dorsal area of the hand and left in place for 24 hours. Ice will be applied on top of the patch 1.5 hrs post patch application and left in place for 1 hr.
15795826|NCT04485663|Drug|ALG-010133|Single or multiple doses of ALG-010133
15795827|NCT04485663|Drug|Placebo|Single or multiple doses of Placebo
15795828|NCT04485650|Other|music therapy|The music were chosen by a researcher under guidance of an expert and grouped as relaxing, classical, mystical, and Turkish folk music. One of them was chosen by the patients following the application of spinal anesthesia in the music group.
15795829|NCT04485650|Other|sedated group|Sedation was performed to the sedated group after spinal anesthesia based on the height and weight data and the doctor's decision. The number of participants:30
15795830|NCT04485650|Other|non-sedated group|The patients in the non-sedated group were followed without any procedure (sedation and music). The number of participants:30
15795831|NCT04485637|Other|Communication with basic table|Communication showing only the normal range of blood pressure readings, which is often used but may make it hard to interpret numbers outside of the normal range
15795832|NCT04485637|Other|Communication with enhanced table|Communication with enhanced table, with reference information showing how combinations of diastolic and systolic blood pressure reflect normal, elevated and hypertension ranges (adapted from the American Heart Association)
15795833|NCT04485637|Other|Communication with enhanced graph|Communication with enhanced graph, showing reference information about how to interpret blood pressure readings (adapted from Blood Pressure UK) with diastolic blood pressure on the x-axis and systolic blood pressure on the y-axis
15795834|NCT04485624|Other|No intervention|Observational study
15795835|NCT04485611|Behavioral|Supervised aerobic + resistance training and nutritional support|The intervention will consist of individualized exercise training delivered remotely using VA telehealth technology, combined with nutritional support consisting of tailored nutritional advice, protein supplementation, multivitamin and vitamin D supplements]]. Adherence to the intervention will be enhanced by use of automated text messages and monitored using activity trackers.
15795836|NCT04485585|Drug|BR9006-1|Administration to the T/T+M group: 0.2 mg of BR9006-1 will be administered one capsule once a day, five-day repeated-dose
15796745|NCT04478292|Procedure|Biopsy|Tumors are deemed unresectable at diagnosis.
15795837|NCT04485585|Drug|BR9006-2|"Administration to the M group: 50 mg of BR9006-2 will be administered one tablet once a day, eleven-day repeated-dose
~Administration to the T+M group: 50 mg of BR9006-2 will be administered one tablet once a day, five-day repeated-dose"
15795838|NCT04485572|Diagnostic Test|Straight Leg Raise test (SLR) and Bragard test (B)|The following neurodynamic and/or orthopedic tension tests were done: the Straight Leg Raise test (SLR), the Bragard test (B) and another test which was the combined test of both (SLR+B)
15795839|NCT04485572|Diagnostic Test|Fajersztajn test (F) and Sicard test (S)|The following neurodynamic and/or orthopedic tension tests were done: the Fajersztajn test (F), the Sicard test (S) and another test which was the combination of both (F+S)
15795840|NCT04485572|Diagnostic Test|Passive Neck Flexion test (PNF)and Kernig test (K)|The following neurodynamic and/or orthopedic tension tests were done: the Passive Neck Flexion test (PNF), the Kernig test (K) and another test which was the combination of both (PNF+K)
15795841|NCT04485572|Diagnostic Test|Slump test (ST) and Dejerine triad (DT)|The following neurodynamic and/or orthopedic tension tests were done: the Slump test (ST), the Dejerine triad (DT) and another test which was the combination of both (ST+DT)
15795842|NCT04485572|Diagnostic Test|MRI scan|All participants will undergo a MRI scan to compare results between the index tests and the Gold Standard
15795843|NCT04485559|Drug|Everolimus|Given PO
15795844|NCT04485559|Drug|Trametinib|Given PO
15795845|NCT04485546|Drug|cenegermin-bkbj|Cenegermin-bkbj ophthalmic solution administered as one drop in affected eye(s) every 2 hours 6 times daily for 8 weeks
15795846|NCT04485533|Device|VisuXL® Gel|"VisuXL® ophthalmic gel, available in a multidose 10ml bottle without preservatives based on Coenzyme Q10, Vitamin E TPGS and cross-linked sodium carboxymethylcellulose.
~Dose/dosage: 1 drop per eye twice a day."
15795847|NCT04485533|Device|HYLO®|"HYLO® ophthalmic solution, a phosphate- and preservative-free sterile eye drops containing 2 mg/ml of hyaluronic acid sodium salt, a citrate buffer, sorbitol and water.
~Dose/dosage: 1 drop per eye twice a day"
15795848|NCT04485520|Other|CARICA PAPAYA MOUTHWASH|Each application was 10 ml. applied for 1 minute, once a day for 8 days
15795849|NCT04485520|Other|CHLORHEXIDINE MOUTHWASH|Each application was 10 ml. applied for 1 minute, once a day for 8 days
15795850|NCT04485507|Other|Nature-VR|Viewing 360 degree nature pictures delivered by a virtual reality headset for 10 minutes/day, 5 days/week for 4 weeks (total of 200 minutes).
15795851|NCT04485507|Other|Urban-VR|Viewing 360 degree urban pictures delivered by a virtual reality headset for 10 minutes/day, 5 days/week for 4 weeks (total of 200 minutes).
15795852|NCT04485494|Diagnostic Test|Biochemical Analysis of Blood Biomarkers|Using established biochemical techniques, the bloods will be probed for specific biomarkers s100B, UCH-L1, GFAP, and BDNF. The techniques include individual ELISA kits for each biomarker mentioned and Luminex multiplate assay which will probe for all biomarkers in one plate. Ultimately, these techniques will be able to measure the level of these biomarkers in the blood relative to the participants baseline reading.
15795853|NCT04485481|Drug|ADX-914|Single dose from 0.1mg/kg to TBD
15795854|NCT04485481|Drug|Placebo|Matching single dose placebo
15795855|NCT04485481|Drug|ADX-914|Multiple dose from TBD to TBD
15795856|NCT04485481|Drug|Placebo|Matching multiple dose placebo
15795857|NCT04485468|Other|Questionnaire|The patient answers the questionnaire directly following his consultation or teleconsultation or may arrange a telephone appointment with the clinical research associate a little later.
15795858|NCT04485455|Device|iTBS Device/Motor Threshold Coil|Motor Threshold determination, done prior to starting treatments, determines the location and the intensity for the iTBS treatments. A magnetic field is applied with increasing intensity stimulating the motor region of the brain until there is thumb movement; this indicates the intensity of the treatments; the location for treatment is in the sensory area parallel to this location.
15795859|NCT04485455|Device|iTBS Device/Treatment Coil|iTBS is a particular TMS protocol which delivers the magnetic field in triplet bursts (three stimulations very close together at a frequency of 50 Hz very quickly). The triplet bursts are repeated at a rate of 5 Hz for 2 seconds (30 pulses), followed by 8 seconds rest, repeated 20 times for a total of 600 pulses. Each treatments lasts approximately 3 minutes, and sessions are provided 20 times (Monday-Friday for 4 consecutive weeks).
15795860|NCT04485442|Other|data collection by questionnaires|psychological well-being in patients evaluated by Patient Reported Outcomes (PRO)
15795861|NCT04485442|Other|data collection (photos of the patients' tumors)|photos of the patients' tumors will be taken at baseline and at follow-up after the surgery
15795862|NCT04485429|Drug|Methylprednisolone|Methylprednisolone 0.5 mg/kg every 12 hours intravenously for the first 14 days; followed by 0.5 mg/kg/day from day 15 to day 21; followed by 0.25mg/kg/day from day 22 to day 25; followed by 0.125 mg/kg/day, from day 26 to day 28 of treatment.
15795863|NCT04485429|Drug|Heparin|Enoxaparin 1 mg/kg subcutaneously every 12 hours (if creatinine clearance greater than 40ml/min) or Unfractionated heparin dosed to target activated partial thromboplastin time (aPTT) between 1.5 - 2.0 times the normal value (if creatinine clearance less or equal to 40ml/min). The treatment period with full-dose heparin will be 7 days. After 7 days of full-dose heparin, patients will continue using prophylactic dose of heparin, according to the standard treatment routine.
15795864|NCT04485416|Drug|Eltrombopag|Eltrombopag is an orally administered small-molecule nonpeptide TPO-R agonist.
15795865|NCT04485403|Drug|Ibuprofen|800 mg/day ( 2 x 400mg) for 3 weeks in women with a bodyweight <70 kg, and a dose of 1200 mg/day (3x400mg) in women weighing> 70kg. The effects of treatment will be compared on the basis of changes in the hormonal profile and inflammatory markers, as well as the clinical assessment of the patient.
15795866|NCT04485390|Other|Basic life support witn use of an AED before EMS|BLS performance with use of an AED before arrival of EMS
15795867|NCT04485351|Other|no intervention|no intervention
15795868|NCT04485325|Drug|Tofacitinib|5 mg twice daily, p.o.
15795869|NCT04485325|Biological|Etanercept|50 mg once per week, s.c.
15795870|NCT04485312|Behavioral|preventive protocol|preventive protocol
15795871|NCT04485312|Behavioral|chlorhexidine added to the preventive protocol|chlorhexidine varnish added to the preventive protocol
15795872|NCT04485299|Drug|Bifluorid 10 ,VOCO|NaF and CaF 10 %
15795873|NCT04485299|Drug|Sodium Fluoride 5% Dental Varnish|5% NaF
15797024|NCT04475913|Other|CIG Axial|patients received 4 axial implants and conventional impression
15795874|NCT04485286|Drug|[68Ga]CBP8|Up to 15 mCi of [68Ga]CBP8 will be administered to each subject. Each subject will undergo baseline imaging prior to radiation and again 3-6 months after radiation therapy.
15795875|NCT04485273|Device|Laryngeal Mask Airway|Capnography connected to laryngeal mask airway is introduced after adequate jaw relaxation and oral airway tolerance; its size is chosen according to the body weight of the child.
15795876|NCT04485273|Drug|Sevoflurane|Sevoflurane in air/oxygen mixture of 40% is titrated to achieve adequate depth of anesthesia.
15795877|NCT04485273|Procedure|Subtenon's Block|Subtenon's block is performed in the eye undergoing surgery under sterile conditions where a 19-gauge curved blunt metallic cannula (25 mm) is inserted into sub-tenon's space.
15795878|NCT04485273|Drug|Local Anesthetic Solution and Dexmedetomedine|The local anesthetic solution is injected with a dose of 0.5% bupivacaine (0.08 ml/kg), in addition to dexmedetomedine (0.5 μg /kg)
15795879|NCT04485273|Drug|Local Anesthetic Solution|The local anesthetic solution is injected with a dose of 0.5% bupivacaine (0.08 ml/kg).
15795882|NCT04485247|Procedure|Transumbilical Laparoscopic-Assisted Appendectomy|appendectomy performed extracorporeally through umbilical port
15795883|NCT04485247|Procedure|3-port laparoscopic appendectomy|appendectomy performed intracorporeally with 3-port
15795884|NCT04485234|Diagnostic Test|Resting distal coronary to aortic pressure ratio, Fractional flow reserve, Coronary Flow Reserve, Microvascular resistance|Calculation of the resting mean distal coronary to aortic pressure ratio (resting Pd/Pa), fractional flow reserve (Pd/Pa at hyperemia), Coronary flow reserve (peak flow/resting flow), microvascular resistance (Pd/flow).
15795885|NCT04485208|Device|Focused Ultrasound|The DWL Doppler ultrasound device enables visual and auditory waveform confirmation of the anterior cerebral artery, and optical tracking technology (e.g., AntNeuro Visor2™ system) may be used in tandem with the Brainsonix Pulsar 1002 ultrasound device to track a patient's brain in virtual space as well as their physical location, thereby ensuring accurate placement.
15795886|NCT04485195|Drug|Vernakalant|an initial infusion of 3 mg/kg infused over a 10-minute period by a pre-programmed IV pump
15795887|NCT04485195|Drug|Procainamide|15 mg/kg in 500 mL of normal saline given over 60 minutes
15795888|NCT04485182|Other|Underwater jet massage (Tangentor)|"Underwater jet massage (Tangentor) would be performed in a tub developed for this purpose, where the water temperature: 33-35 ° C. The treatments lasting from 15 atm and 15 cm for 15 minutes.
~They take a minimum of 10 treatments for approx. under 2 weeks."
15795889|NCT04485169|Procedure|Therapeutic Plasma Exchange|a. 1-1.5 plasma volume exchange, 2/3rd plasma should be replacing with FFP to avoid coagulopathy, adequate dieresis to prevent volume overload, 1-5 sessions in total, 1 session daily
15795890|NCT04485156|Drug|High-dose rifampicin|30mg/kg
15795891|NCT04485156|Drug|Isoniazid|300mg
15795892|NCT04485156|Drug|Pyrazinamide|20-30mg/kg
15795893|NCT04485156|Drug|Ethambutol|15-20mg/kg
15795894|NCT04485156|Drug|Rifampicin|10mg/kg
15795895|NCT04485143|Device|Wisdom bracelet|routine medical
15795896|NCT04485130|Drug|Disulfiram|This study will provide disulfiram. Participants in Cohort 1 receiving disulfiram will take 2 capsules of disulfiram (each capsule contains 500 mg DSF plus 27.75 mg microcrystalline cellulose powder) per day for a total of 5 consecutive days. Participants in Cohort 2 receiving placebo will take 4 capsules of disulfiram (each capsule contains 500 mg DSF plus 27.75 mg microcrystalline cellulose powder) per day for a total of 5 consecutive days.
15795897|NCT04485130|Drug|Placebo|This study will provide placebo. Participants in Cohort 1 receiving placebo will take 2 capsules of placebo (each capsule contains only microcrystalline cellulose powder) per day for a total of 5 consecutive days. Participants in Cohort 2 receiving placebo will take 4 capsules of placebo (each capsule contains only microcrystalline cellulose powder) per day for a total of 5 consecutive days
15795898|NCT04485117|Device|Bispectral Index Monitor|Bispectral Index (BIS) sensor electrodes are applied over the patient's forehead after cleaning the forehead thoroughly with an alcohol swab.
15795899|NCT04485117|Device|Laryngeal Mask Airway|Capnography connected to laryngeal mask airway is introduced after adequate jaw relaxation and oral airway tolerance; its size is chosen according to the body weight of the child.
15795900|NCT04485117|Drug|Sevoflurane|Anesthesia is induced inhalationally by face mask with 8% sevoflurane in 100% oxygen, then decreased to 2-3% in 40% oxygen thoroughout the operation for maintenance of anesthesia.
15795901|NCT04485117|Drug|Propofol|Anesthesia is induced by propofol (2mg/kg), then maintained using an infusion of fixed concentration (10-15 mg/kg/h) as titrated by the anesthesiologist .
15795902|NCT04485104|Drug|GWP42003-P|100 milligram/milliliter cannabidiol
15795903|NCT04485104|Drug|SOC|SOC with participant's current antiepileptic regimen
15795904|NCT04485091|Combination Product|20% TCM and PBM|The chemical peel (20% TCM) will be carried out monthly, totaling 04 sessions. The application of photobiomodulation (PBM) will start shortly after the observation of frosting level I, which characterizes an exfoliation of superficial depth. Although the application sessions take place monthly, medical evaluations will be carried out fortnightly for the other orientations, filling in scales and photographs. For the PBM, a LED device with an irradiance of 10 milliwatts per square centimeter (mW/cm²) in continuous operation mode and a wavelength of 660 nm will be used. It will provide an energy density of 4 J/cm² within 400 seconds of irradiation.
15795905|NCT04485091|Other|20% TCM and PBM placebo|The chemical peel (20% TCM) will be carried out monthly, totaling 04 sessions. The application of photobiomodulation (PBM) will be simulated soon after the observation of frosting level I. The patient will not be aware of the simulation of the procedure. Although the application sessions take place monthly, medical evaluations will be carried out fortnightly for the other orientations, filling in scales and photographs.
15795973|NCT04484688|Drug|perindopril-bisoprolol|outpatients with permanent atrial fibrillation and with preserved ejection fraction
15795974|NCT04484675|Drug|Milrinone inhalation|After induction of anesthesia and stable hemodynamics inhaled milrinone( 1 mg/ml) is initiated and intravenous placebo ( normal saline )infusion are administered
15795975|NCT04484675|Drug|Milrinone infusion|After induction of anesthesia and stable hemodynamics inhaled placebo( normal saline) is initiated and intravenous ( 1 mg/ml) (0.5 μg/kg/min)infusion are administered
15795906|NCT04485078|Diagnostic Test|Pressure pain threshold|The PPT assessments of spine will be performed over the spinous process and 2 cm right and left side of the corresponding spinous process. The regional PPT scores will be composed from sum of all PPT values for related segments at spine. The sacroiliac PPT scores will be obtained bilaterally from four measurement points; the first point is located 1 cm medially and caudally from spina iliaca posterior superior (SIPS) and 3 more laterally, medially and cranially.The left trapezius muscle will be used to evaluate distant control point .The 1 cm2 algometer probe will be placed vertically in the each selected point and pressure will be increased with 0.1 kg/sc until the participant reporting pressure became painful. The pressure value at which the pain is first felt will be accepted as the PPT of that point.
15795907|NCT04485078|Diagnostic Test|Temporal summation|TS will be evaluated over the trapezius muscle, sacroiliac joints, C7, T6, and L3 levels at spine with manuel algometer. TS scores will be calculated for each spine level as the sum of three values which measured over the spinous process and 2 cm right and left side of corresponding level. In the evaluation of TS, a pressure as much the PPT value of each point will be applied with pain pressure algometer ten times with a 1-second interstimulus interval. Patients will be asked to rate their pain using on a 0 to 10 visual analogue scale (VAS) at 0, 5, and 10 seconds. TS will be calculated by subtracting the rating at 0 seconds from the rating at 10 seconds. The point that is located 1 cm medially and caudally from SIPS was used for SI joint TS measurement on both sides.
15795908|NCT04485078|Diagnostic Test|Conditioned pain modulation|First stimulus will be applied to trapezius with the pressure that induced a pain intensity of 4 point on a 10 point VAS as called a test stimulus. After that the right hand of the patient will be immersed in 70C water for 20 seconds to create a conditioning stimulus. Second test stimulus with the same intensity of first one will be applied to trapezius after the conditioning stimulus and patients will be asked to rate their pain. If the patients cannot hold their hand in the water for 20 seconds, the test stimulus will be applied immediately after the patients removed their hands out of water. The ratio between the first and second VAS values multiplied by 100 will be defined as CPM score
15795909|NCT04485078|Diagnostic Test|Central Sensitization Inventory|Standardized questionnaire to determine the level of central sensitization
15795910|NCT04485078|Other|Bath Ankylosing Spondylitis Disease Activity Index|Standardized questionnaire to determine the level of disease activity in AxSpa patients
15795911|NCT04485078|Other|Ankylosing Spondylitis Quality of Life|Standardized questionnaire to investigate the quality of life in AxSpa patients
15795912|NCT04485078|Other|Istanbul Low Back Pain Disability Index|Standardized questionnaire to investigate the disability
15795913|NCT04485078|Other|Beck Depression Inventory|Standardized questionnaire to investigate the depression
15795914|NCT04485078|Other|Fatigue Severity Scale|Standardized questionnaire to investigate the fatigue
15795915|NCT04485078|Other|Pittsburgh Sleep Quality Index|Standardized questionnaire to investigate the sleep quality and disturbance
15795916|NCT04485078|Other|Fibromyalgia Rapid Screening Tool|Standardized questionnaire to detect fibromyalgia
15795917|NCT04485078|Other|Visual analogue scale|global pain score on a 0 to 10
15795918|NCT04485065|Drug|IBI188+azacitidine|"IBI188 will be administered 30mg/kg, IV (intravenous infusion), Q4W
~Drug:Azacitidine Azacitidine will be administered daily for 7 days, IH, Q4W"
15795919|NCT04485065|Drug|Drug:Azacitidine|Azacitidine will be administered 75mg/m^2 according to body surface area (BSA) daily for 7 days, IH (hypodermic injection), Q4W
15795920|NCT04485052|Drug|IBI188|IBI188 will be administered 30mg/kg, IV (intravenous infusion), Q4W
15795921|NCT04485052|Drug|Azacitidine|Azacitidine will be administered 75mg/m^2 according to body surface area (BSA) daily for 7 days, IH (hypodermic injection), Q4W
15795922|NCT04485039|Drug|TPOXX|oral antiviral and phosphate binders
15795923|NCT04485026|Radiation|Local consolidative radiation therapy|All local consolidative radiation therapy should be delivered using hypofractionated local consolidative radiation therapy (>2 Gy per fraction). Exceptions may be approved on a case by case basis by the trial principal investigator. Three-dimensional conformal radiotherapy (3D-CRT), intensity modulated radiation therapy (IMRT), volumetric modulated arc therapy (VMAT), stereotactic body radiotherapy (SBRT), stereotactic radiosurgery (SRS), and proton beam therapy (PBT) are all acceptable.
15795924|NCT04485026|Drug|Standard of care radiation therapy|Standard of care palliative radiotherapy to symptomatic lesions is permissible. The dose to symptomatic lesions should not exceed 30 Gy in 10 fractions. Brain metastases will be treated with standard of care CNS therapy throughout the study. This may include (but is not limited to) stereotactic radiosurgery, neurosurgical intervention, whole brain radiotherapy
15795925|NCT04485013|Drug|TTX-080|Variable dose (Q3W)
15795926|NCT04485013|Drug|TTX-080|Specified dose (Q3W)
15795927|NCT04485013|Drug|pembrolizumab|Specified dose (Q3W)
15795928|NCT04485013|Drug|cetuximab|Specified dose on specified days
15795929|NCT04485000|Behavioral|Online 1-Day Cognitive Behavioural Therapy (CBT)-Based Workshop|The workshop is a day-long intervention delivered in 4 modules based on Cognitive Behavioural Therapy (CBT). The workshop covers PPD etiology, modifiable cognitive risk factors, cognitive skills, behavioural skills, problem solving, goal setting and action planning. Each participant is given a professionally designed manual to facilitate learning. Weekly reminder emails are sent for 6 weeks after the workshop completion to encourage practice. A list of PPD resources and a copy of the Canadian Treatment Guidelines for Postpartum Depression are provided.
15795930|NCT04484987|Other|9 hours daily eating window|Participants assigned to the TRE group will have to consume all their daily meals and snacks during a 9-hour window for 12 weeks.
15795931|NCT04484987|Other|15 hours daily eating window|Participants assigned to the control group will have to consume all their daily meals and snacks during a 15-hour window for 12 weeks.
15795932|NCT04484974|Other|Pecan snack|Under this condition, each participant will consume a mid morning snack of pecans followed by an ad libitum lunch.
15795933|NCT04484974|Other|Pretzel snack|Under this condition, each participant will consume a mid morning snack consisting of an iso-caloric (equal to the pecan snack) snack of pretzels followed by an ad libitum lunch.
15795934|NCT04484961|Device|Blood flow restriction (BFR)|The study group underwent normal ACL rehab modified by use of a tourniquet for blood flow restriction during selected exercises.
15795976|NCT04484662|Other|Potted Mint Plants|We will measure 2 indoor environments (living room and bedroom) for placing potted plants.
15795935|NCT04484948|Other|scleroderma health assessment questionnaire (SHAQ), BHT, and 6MWT|"Participants will perform the SHAQ.
~BHT and 6MWT will be performed in the randomized way for each participant.
~For BHT, the participants will be told to sit comfortably on a chair, and breath normally. After 1 minute, they were required to make a maximum expiration followed by a maximum inspiration and to hold the breath as long as possible at maximum inspiratory level. This procedure was repeated three times, with 5-minute intervals between the tests.
~6MWT will be performed according to the ATS guidelines.
~Information on CXR, TTE, and PFT (FVC%, DLCO%) will be obtained from the medical record if the data was obtained within 3 months. If not, the tests will be performed.
~BHT and PFT will be followed by six months after the first breath-holding test to confirm the responsiveness.
~Additional 30 patients with systemic sclerosis will be collected to perform the test-retest reliability of BHT."
15795937|NCT04484922|Drug|Dexmedetomidine|continuous infusion of dexmedetomidine during the surgery
15795938|NCT04484922|Drug|Normal saline|continuous infusion of normal saline during the surgery
15795939|NCT04484909|Other|Hafnium Oxide-containing Nanoparticles NBTXR3|Given IT
15795940|NCT04484909|Radiation|Radiation Therapy|Undergo radiation therapy
15795941|NCT04484896|Other|Gain-framed SMS message|Emergency recruitment cell phone short messages that emphasizing donating blood can save patients' lives were sent to donors in this group.
15795942|NCT04484896|Other|Loss-framed SMS message|Emergency recruitment cell phone short messages emphasizing that donating blood can prevent patients from death were sent to donors in this group.
15795943|NCT04484896|Other|Information SMS message|Emergency recruitment cell phone short messages that only mentioning the low Rh-negative blood stockpile were sent to donors in this group.
15795944|NCT04484883|Other|Observational|Observational
15795945|NCT04484870|Drug|oral Danshu capsule|Danshu group oral Danshu capsule, 2 tablets per time, 3 times a day (0.45g/ tablets, Sichuan Jishengtang Pharmaceutical Co., Ltd.)
15795946|NCT04484857|Drug|Roxadustat|This open-label single arm study is designed to evaluate roxadustat dosing in maintaining hemoglobin in ESRD subjects receiving chronic dialysis treatments
15795947|NCT04484844|Drug|TOKUYAMA SHIELD FORCE PLUS|Self-reinforcing (SR) monomer technology
15795948|NCT04484844|Drug|Sodium Fluoride 5% Dental Varnish|5% NaF
15795949|NCT04484831|Behavioral|ABT Weight Loss Intervention|This includes 15 sessions that are each 90 minutes in length. Intervention sessions will be weekly for the first 2 months, bi-weekly for the next 2 months, and monthly for the last 2 months.
15795950|NCT04484831|Other|Enhanced Care|This includes 15 handouts on elements of a healthy lifestyle and a midpoint one-on-one nutrition consultation with a registered dietitian.
15795951|NCT04484818|Drug|Darolutamide|Given PO
15795952|NCT04484818|Drug|Goserelin Acetate|Given via injection
15795953|NCT04484818|Drug|Leuprolide Acetate|Given IV
15795954|NCT04484818|Drug|Placebo Administration|Given PO
15795955|NCT04484818|Other|Quality-of-Life Assessment|Ancillary studies
15795956|NCT04484818|Drug|Triptorelin|Given via injection
15795957|NCT04484805|Device|ICE Condition|Experimental socket integrated with a heat spreader. An ICE Unit (includes TEC) is attached to the socket.
15795958|NCT04484805|Device|Sham Condition|Experimental socket integrated with a heat spreader. A Sham Unit (excludes TEC) is attached to the socket.
15795959|NCT04484792|Other|green tea mouthwash|green tea bags in 100 ml warm water for 5 min
15795960|NCT04484792|Other|green tea mouthwash|, in Group B its prepared by soaking tea bags in 100 ml hot water followed by ice addition.
15795961|NCT04484792|Other|placebo|Plain water
15795962|NCT04484779|Device|IIM System|IIM System
15795963|NCT04484779|Drug|Insulin Lispro and/or Insulin Glargine|Administered subcutaneously (SC)
15795964|NCT04484766|Other|Primary data collection|"Primary data collection takes place via questionnaires outside the study centre.
~All other investigations take place at the study centre:
~Physical examination: height, weight, BMI, blood pressure
~Cardiac examination: cardiac output
~Vascular measurements: Carotid intima media thickness, total peripheral resistance, blood pressure, flow-mediated vascular dilatation, critical flicker frequency, pulse wave velocity, augmentation index
~Serum analysis: basic laboratory, multiplex analysis (human vascular inflammation, human angiogenesis and adhesion molecule panel)"
15795965|NCT04484753|Other|Home Exercise Sheet|Received a sheet with pelvic floor muscle training guidelines to be performed at home. After 3 months all volunteers were reevaluated.
15795966|NCT04484753|Other|Ipelvis mobile application|Received the iPelvis® Application with pelvic floor muscle training guidelines to be performed at home. After 3 months all volunteers were reevaluated.
15795967|NCT04484753|Behavioral|Home exercise sheet + Pelvic Physiotherapy|Performed 12 Pelvic Physiotherapy sessions, in group, once a week and received a sheet with pelvic floor muscle training guidelines to be performed at home. After 3 months all volunteers were reevaluated.
15795968|NCT04484753|Behavioral|Ipelvis mobile application + Pelvic Physiotherapy|Performed 12 pelvic physiotherapy sessions, in group, once a week and received the iPelvis® Application with pelvic floor muscle training guidelines to be performed at home. After 3 months all volunteers were reevaluated.
15795969|NCT04484740|Drug|Gepotidacin|Single oral dose of 1500 mg gepotidacin
15795970|NCT04484727|Other|PEEP-step method|By changing PEEP in one or two steps up and down, transpulmonary pressure and the lung P/V curve can be determined using a dedicated software collecting data on tidal-volume changes and pressure changes during the PEEP-changes from the standard monitoring equipment or ventilator.
15795971|NCT04484714|Behavioral|Exercise|Participants will participate in a 12-week virtually supported home-based aerobic and resistance exercise program, twice weekly using the Heal-Me application. Sessions will be completed as virtual live classes or supported follow-along independent home workouts. Sessions will progress in duration and difficulty over the course of the program, aiming to have participants meet the 2019 Exercise Guidelines for Cancer Survivors by the end of the program. Each session will include aerobic exercise (i.e. walking, cycling, or cardio circuit), and a full-body resistance training routine using free weights, body weight exercises, and/or bands, followed by balance and stretching exercises.
15795972|NCT04484701|Drug|68Ga-PSMA-11|PET/CT scan with radiotracer 68Ga-PSMA-11
15795977|NCT04484649|Behavioral|Sleeping Healthy/Living Healthy|Sleeping Healthy/Living Healthy will be a school based health center (SBHC)-based intervention integrating mind-body integrative health (MBIH) and sleep hygiene strategies to improve sleep quality in urban adolescents. The Sleeping Healthy/Living Healthy intervention content and format will be determined in a Development Phase 1. We anticipate the intervention will consist of two group and two one-on-one sessions. The intervention will be grounded in social-cognitive theory and use motivational interviewing to support MBIH and sleep hygiene strategies. Sessions will be delivered once per week by SBHC providers and health educators.
15795978|NCT04484649|Behavioral|Attention Control|"The Attention Control Intervention condition will meet the requirements for a comparison treatment for testing behavioral interventions - equivalent in contact time, credible and interesting, and exert limited treatment effects.
~In the same number of sessions and format as the Sleeping Healthy/Living Healthy intervention (anticipated to be two group and two one-on-one sessions delivered once per week by SBHC providers and health educators), we will teach participants about sleep and other health topics relevant to adolescents (e.g., nutrition, injury prevention) devoid of the MBIH elements in our integrated intervention."
15795979|NCT04484636|Diagnostic Test|FoundationOne®CDx and FoundationOne®Liquid|FoundationOne CDx is a FDA-approved broad companion diagnostic (CDx) that is clinically and analytically validated for solid tumors. The test is designed to provide physicians with clinically actionable information - both to consider appropriate therapies for patients and understand results with evidence of resistance - based on the individual genomic profile of each patient's cancer. Every test result includes microsatellite instability (MSI) and tumor mutational burden (TMB) to help inform immunotherapy decisions. FoundationOne®Liquid is a liquid biopsy test for solid tumors that analyzes circulating tumor DNA (ctDNA) in blood.
15795980|NCT04484623|Drug|Belantamab mafodotin|Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate will be administered.
15795981|NCT04484623|Drug|Pomalidomide|Immunomodulatory imide drug (IMiD) will be administered.
15795982|NCT04484623|Drug|Dexamethasone|Synthetic glucocorticoid with anti-tumor activity will be administered.
15795983|NCT04484623|Drug|Bortezomib|Proteasome Inhibitor will be administered.
15795984|NCT04484610|Drug|Pharmacist Practice Change to Dispense Appropriate Opioid Quantities for Acute Pain|Pharmacist eLearning modules, support tools and resources to promote assessing and dispensing appropriate opioid quantities for acute pain.
15795985|NCT04484597|Diagnostic Test|Rt PCR|positive COVID-19 by PCR and tested for other ancillary tests and CT chest to compare them and analyse which is the most sensitive in both moderate and severe clinical condition
15795986|NCT04484584|Other|complex decongestive therapy|Manual lymphatic drainage Manuel lymphatic drainage therapeutic technique is used for reducing edema and symptoms related with edema by accelerating lymphatic drainage. The aim of massage along the extremity is to provide fluid drainage.Manuel lymphatic drainage stimulates the internal contraction of lymphatic channels. If interstitial space concentration of protein is reduced, it provides drainage of obstructed lymph fluid from local lymph nodes.
15795987|NCT04484571|Device|Neuroexsos elbow module|The treatment group will be further divided into two levels (sub-groups), based on pathological severity: Level 1 corresponds to an FM score equal or below 28, and Level 2 with FM greater than 28. The two sub-groups will receive different combinations of robotically assisted passive mobilization (PM) and active mobilization (AM) treatment modalities, according to their differing clinical needs
15795988|NCT04484558|Drug|Actilyse|Infusion
15795989|NCT04484545|Diagnostic Test|Prognostic score|Validation of scores of systemic inflammatory response
15795990|NCT04484532|Biological|Trivalent Influenza Vaccine|Given IM
15795991|NCT04484519|Other|Functional Magnetic Resonance Imaging|Functional Magnetic Resonance Imaging
15795992|NCT04484506|Drug|pegaspargase, cyclophosphamide, vincristine, etoposide, prednisone|Cyclophosphamide 750 mg/m2 intravenously on day 1, vincristine 1.4 mg/m2 intravenously on day1, etoposide 60mg/m2 intravenously on days 1-3; pegaspargase 2500IU/m2 intramuscularly on day 2, prednisone 100mg orally on days 1-5.
15795993|NCT04484493|Drug|mometasone furoate nasal spray|dose of 2 puff in each nostril (100 µg once daily each nostril).
15795994|NCT04484480|Procedure|Balance training|Proprioception, balance and motor coordination training using the dynamic platform - Biodex Balance System.
15795995|NCT04484467|Dietary Supplement|Food Supplement With Standardized Menthol, Limonene, and Ginger|Components of Standart Zdorovya GASTRO: Peppermint oil (40% menthol, 1.5% limonene) - 240 mg, Ginger oil (14% gingerol) - 50 mg, olive oil - 440 mg, 1 capsule, 730 mg, once a day for 30 days
15795996|NCT04484467|Other|Placebo|Components of placebo Olive oil - 730 mg, 1 capsule, 730 mg, once a day for 30 days
15795997|NCT04484454|Dietary Supplement|ProdromeNeuro Omega 3 Oil Nutritional Supplement|ProdromeNeuro is an algae-derived Omega 3 oil nutritional supplement product comprised of naturally occurring alkylglycerol and natural fatty acids. ProdromeNeuro functions as a natural plasmalogen precursor which can be administered orally.
15795998|NCT04484441|Other|Blood and placenta specimen collection.|Collection of maternal and paternal blood. Collection of infant cord blood and placenta.
15795999|NCT04484428|Drug|K-285|88 subjects are to be assigned to 1 week dosing, four times a day (QID) (Period 1), and 32 are to be assigned to 3 weeks dosing (Period 1 and Period 2) with 16 subjects each in the two times a day (BID) and QID dosing regimens.
15796000|NCT04484428|Drug|Menthol|88 subjects are to be assigned to 1 week dosing, four times a day (QID) (Period 1), and 32 are to be assigned to 3 weeks dosing (Period 1 and Period 2) with 16 subjects each in the two times a day (BID) and QID dosing regimens.
15796001|NCT04484415|Combination Product|Cevira®|The device is a single-use, disposable, LED-based red light source. The device will automatically switch on the light 5 hours after administration, and provide continuous photoactivation of 125 J/cm2 over 4.6 hours before automatically shutting down.
15796002|NCT04484415|Combination Product|Placebo|The placebo device is identical in appearance as the Cevira® device, but does not provide light.
15796003|NCT04484402|Biological|mesenchymal stem cells|Autologous adipose-derived mesenchymal stem cells mixed with sodium hyaluronate 1% solution
15796004|NCT04484402|Biological|limbal stem cells|Autologous adipose-derived limbal stem cells mixed with sodium hyaluronate 1% solution
15796005|NCT04484402|Other|standard treatment|Standard treatment according to the Clinical protocols
15796066|NCT04483895|Procedure|Endotracheal tube insertion|ETT was inserted and the depth was estimated by either OHL method or 7-8-9 method
15796006|NCT04484389|Other|Telerehabilitation|Exercise protocol according to Ipaq will be prepared for 30 patients with chronic disease . Exercise protocol; warm-up exercises include, stretching exercises, postural exercises, aerobic exercise and cooling exercises. People will practice the exercises 3 days a week for 6 weeks. People will need to reserve 30 minutes a day for this study.
15796007|NCT04484389|Other|Exercise brochure|General exercise protocol will be prepared and given to the control group as a brochure
15796008|NCT04484363|Drug|Pevonedistat|Pevonedistat 20 milligram per square meter (mg/m^2), intravenous infusion, on Days 1, 3, and 5 of repeated 28-day cycles.
15796009|NCT04484363|Drug|Azacitidine|Azacitidine 75 mg/m^2, intravenous or subcutaneous infusion, on Days 1 to 5, Days 8 and 9 of repeated 28-day cycles or Days 1 through 7 of repeated 28-day cycles.
15796010|NCT04484350|Drug|Labetalol|10 - 20 mg IV q15 minutes PRN until systolic BP below target (max 300 mg per 24 hours)
15796011|NCT04484350|Drug|Hydralazine|10 - 20 mg IV bolus q20 min until systolic BP below target (max 240 mg per 24 hours)
15796012|NCT04484350|Drug|Enalapril|1.25 - 2.5 mg IV bolus and then q6h PRN.
15796013|NCT04484337|Drug|Cabotegravir sodium (Oral Lead In)|CAB will be available as 30 mg tablets for oral administration.
15796014|NCT04484337|Drug|Cabotegravir 400 mg/mL|CAB 400 mg/mL will be available for administration by IM injection or SC Injection.
15796015|NCT04484337|Drug|Cabotegravir 200 mg/mL|CAB 200 mg/mL will be available for administration by IM injection or SC Injection.
15796016|NCT04484324|Other|Stretching exercises|Post-facilitation stretch is a technique involves a maximal contraction of the muscle at mid-range with a rapid movement to maximal length followed by a static stretch.
15796017|NCT04484298|Diagnostic Test|Reference position patient is put in a 30 degree supine position during 5 minutes|Each patient is initially placed in a semi-sitting position at 30° for 5 minutes and then CO is measured (baseline CO)
15796018|NCT04484298|Diagnostic Test|nitroglucerin|0.6 mg of Nitroglycerin was administered by sublingual root and CO was evaluated.
15796019|NCT04484285|Device|Transcutaneous Vagal Nerve Stimulation (tVNS)|vagal nerve stimulation
15796020|NCT04484272|Behavioral|Self-monitoring of pain, stress, and opioid use + alerts/reminders + use of YCWS. [three video banks of RDE + Support]).|Self-monitoring of pain, stress, and opioid use + alerts/reminders + use of YCWS. [three video banks of RDE + Support]).
15796021|NCT04484272|Behavioral|Self-monitoring of pain, stress, and opioid use + alerts/reminders.|Self-monitoring of pain, stress, and opioid use + alerts/reminders.
15796022|NCT04484259|Drug|Ticagrelor monotherapy|Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
15796023|NCT04484259|Drug|Ticagrelor plus aspirin|Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
15796024|NCT04484259|Drug|Clopidogrel with aspirin|Eligible patients will enter a 7-10 day run-in phase with aspirin 81 mg/ qd plus ticagrelor 90 mg bid after which they will discontinue aspirin and maintain ticagrelor 90 mg bid monotherapy for 10±3 days. After this period, patients will be randomized using a randomly generated computer sequence in a 1:1:1 fashion to either: a) ticagrelor 60 mg bid monotherapy; b) aspirin 81 mg qd plus ticagrelor 60 mg bid; c) aspirin 81 mg qd plus clopidogrel 75 mg qd. Randomized treatment will be maintained for 10±3 days.
15796025|NCT04484246|Other|Prevalence of sarcopenia in older patient with prostate cancer|All patients are screened for sarcopenia with the SAR-F questionnaire test score ≥4/10 suspected of sarcopenia will undergo a dual-X-ray exam to dertemine their skeletal muscle mass and the prevalence of sarcopenia before oncological treatment.
15796026|NCT04484233|Device|iAnemia Decision Support System|iAnemia permits to display the appropriate guideline using several inputs about a patient: age, type and delay of the surgery, gender, hemoglobin level, and iron deficiency status.
15796030|NCT04484194|Behavioral|Check Yourself - Oncology|A validated AYA-targeted electronic health assessment (eHA) screening tool for use in oncology clinics.
15796031|NCT04484181|Other|Embryo culture in time lapse technology (TLT)|In the TLT group, the selection for transfer was based on morphological and kinetic criteria (with the use of an algorithm). Embryos will be cultured and selected for fresh transfer.
15796032|NCT04484181|Other|Embryo culture in conventional incubator|For the standard incubation group, the selection for transfer will be based on morphological criteria. Embryos will be cultured and selected for fresh transfer.
15796033|NCT04484168|Procedure|Terminal Interruption of the Reflux Source|Foam Sclerotherapy of veins in the immediate vicinity of the venous ulcer
15796034|NCT04484168|Procedure|Axial Ablation|Endovenous ablation of venous reflux in the main superficial veins of the leg
15796035|NCT04484155|Device|Minimally Invasive Micro Sclerostomy (MIMS)|The System is a surgical device, designed to create a drainage channel at the sclera-corneal junction . The drainage channel is created by a Stainless Steel surgical tool.
15796184|NCT04482816|Device|Right ventricular pacing|Conventional pacing; right ventricular pacing
15796187|NCT04482790|Procedure|Bioclear cervical matrix with injection molding technique|New restorative technique in management of black triangle restorative papilla regeneration
15796037|NCT04484116|Diagnostic Test|Intraoperative Paratohormone|Three IOPTH determinations were withdrawn: at anesthetic induction (PTH0), 15 minutes (PTH15), and 30 minutes (PTH30) after completion gland resection. Another sample was taken 24 hours after the procedure (PTH24), values <150pg/mL defined a successful surgery and patients were assigned to the successful or unsuccessful group. IOPTH drop was analyzed to predict successful surgery with drops of 70% and 90% at 15 and 30 minutes.
15796038|NCT04484103|Other|Assessment of the diagnostic performance of the PI-RADS score (as a stand-alone) and of the RPCRC for predicting the presence of ISUP ≥2 prostate cancer at subsequent biopsy in 251 patients.|"The following features will be retrieved from the CRFs of the patients included in the MRI-FIRST trial: age, DRE findings, PSA level, prostate volume, maximal PI-RADS score; the history of biopsy will be set to a default value of none since all patients included in the MRI-FIRST trial were biopsy naïve.
~Then, the RPCRC will be used to calculate two different risks: the risk of detectable prostate cancer and of significant prostate cancer (ISUP ≥2) at subsequent biopsy.
~The PI-RADS score (as a stand-alone) and the risks predicted by the RPCC will be compared to the results of the prostate biopsy performed during the MRI-FIRST trial.
~Throughout the study, the version 2 of the PI-RADS score will be used."
15796039|NCT04484090|Device|Vertica RF device|The treatment provided by the Vertica device is indicated for improving the erectile function in men with erectile dysfunction
15796041|NCT04484064|Behavioral|Adherence program|This program combines adherence evaluation using an electronic monitor (MEMS®) and feedback with repeated medication adherence interviews with the pharmacist.
15796042|NCT04484051|Drug|Somatropin|The intervention is growth hormone treatment (Genotropin), 0.6 - 0.8 mg/day subcutaneous for one year. It is an intramural medicament with an add-on. Participants start with 0.2 mg/day. The growth hormone dose increases with 0.2 mg/day per month to a maximum dose of 0.6 - 0.8 mg/day based on clinical signs (occurrence of side-effects)
15796043|NCT04484051|Drug|Placebo|The comparator is placebo, 0.6 - 0.8 mg/day subcutaneous for one year. Participants start with 0.2 mg/day. The dose increases with 0.2 mg/day per month to a maximum dose of 0.6 - 0.8 mg/day.
15796044|NCT04484038|Radiation|hypofractionated postoperative radiation therapy|The patients included in the study will undergo intensity-modulated radiotherapy, of any modality, and image-guided (IGRT) with an emphasis on tissue preservation and administration precision through the use of devices that guarantee the stability and reproducibility of the same.
15796047|NCT04484012|Drug|Acalabrutinib|Given PO
15796048|NCT04484012|Biological|CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes|Given IV
15796049|NCT04483986|Procedure|Rectus muscle re-approximation|Study group: we are going to re-approximate rectus muscle wirth minimum 3 stiches.
15796052|NCT04483960|Drug|Nafamostat Mesilate|Nafamostat continuous IV infusion for 7 days or until day of hospital discharge at a dose of 0.2mg/kg/hour. No adjustment in dose is needed for renal impairment, including for renal dialysis. The daily dose of nafamostat should be administered in 500 mL (rate of infusion 20.8 mL/hour) of normal saline. Normal saline is recommended (due to the tendency for patients with COVID-19 towards hyponatraemia) but not mandated, and 5% dextrose would be acceptable if felt clinically appropriate.
15796053|NCT04483960|Biological|Hyperimmune Globulin|2 doses of 30mL (3x10mL vials) of COVID-19 Hyper-Immunoglobulin (Human) given over 2 days within 48 hours of randomisation. Three vials will have approximately 10500 AU of neutralising antibodies, equivalent to approximately 200mL of convalescent plasma
15796054|NCT04483960|Drug|Enoxaparin|"Patients will be administered either a standard dose, intermediate dose or therapeutic anticoagulation of low molecular weight heparin (depending on assigned arm), choice of agent according to availability and local practice at the participating site.
~The maximum dose of Enoxaparin will be 1mg/kg q12h or 1.5mg/kg q24h."
15796055|NCT04483960|Drug|Dalteparin|"Patients will be administered either a standard dose, intermediate dose or therapeutic anticoagulation of low molecular weight heparin (depending on assigned arm), choice of agent according to availability and local practice at the participating site.
~The maximum dose of Dalteparin will be 100IU/kg q12h or 200IU/kg q24h."
15796056|NCT04483960|Drug|Tinzaparin|"Patients will be administered either a standard dose, intermediate dose or therapeutic anticoagulation of low molecular weight heparin (depending on assigned arm), choice of agent according to availability and local practice at the participating site.
~The maximum dose of Tinzaparin will be 175IU/kg q24h (not available within Australia)."
15796057|NCT04483947|Drug|AZD2693|Subcutaneous administration of AZD2693 multiple ascending doses in participants with NASH who are homozygous for the PNPLA3 148M risk allele
15796058|NCT04483947|Other|Placebo|Participants randomised to placebo will receive the corresponding dose volume of solution as participants receiving AZD2693 within the same cohort
15796059|NCT04483934|Biological|Dermal fibroblasts|"Cultured autologous dermal fibroblasts.
~For PR: The name dermal fibroblasts is exactly the name of the cell product registered by our ministry of health. There is no trade or international name."
15796060|NCT04483934|Device|LED phototherapy|LED phototherapy
15796061|NCT04483921|Other|Acute exercise|Participants will complete a morning exercise bout at 70% of their individual maximal aerobic capacity to burn 200 kilocalories above their basal metabolic rate.
15796062|NCT04483908|Diagnostic Test|blood draw|2x 10ml of blood, one vial to obtain the antibodies and one vial in ethylenediaminetetraacetic acid (EDTA) (or citrate-treated) to obtain peripheral blood mononuclear cells (PBMCs)
15796063|NCT04483908|Diagnostic Test|fingertip tests for POC assays|performing POC test by taking two blood drops from the fingertip
15796064|NCT04483908|Diagnostic Test|saliva collection|saliva collection: the patient delivers saliva into an adsorbent filter, which is placed in the Salivette tube, centrifuged at 1,600x g for 15 min at 4°C to remove cells and debris. Native supernatant is used for testing.
15796065|NCT04483908|Diagnostic Test|collection of swabs|collection of nasopharyngeal and oropharyngeal swabs for PCR testing on the control group (eg negative subpopulation)
15797217|NCT04474288|Diagnostic Test|SARS-CoV-2 antibody testing|venipuncture for SARS-CoV-2 IgG
15796067|NCT04483882|Device|Tactile Labels for Drug identity and dose frequency|The tactile labeling proposed in this protocol is rigid labeling. A ring-clip has an inner diameter of 12.5cm, an outer diameter of 16 cm, and a height of 1.5 cm. The ring is cut at 2 cm to form a semi-circle allowing it to be clipped onto the bottleneck. The ring clip fits most if not all prescription eye drop bottles. The individual protrusions with shapes at the end can be cut off by the pharmacist to match the frequency of administration prescribed.
15796068|NCT04483869|Other|Thermography|thermographic image a 1, 3, 5 et 10 minutes of life
15796069|NCT04483856|Device|DermoRelizema cream|Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment
15796070|NCT04483856|Device|Dexeryl|FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).
15796071|NCT04483843|Other|No intervention|No intervention will be performed while it is retrospective observational study.
15796072|NCT04483830|Drug|Sulodexide|an oral dose of 2 capsules each day for 21 days
15796073|NCT04483830|Drug|Placebo|an oral dose of 2 capsules each day for 21 days
15796074|NCT04483817|Device|Transcutaneous tibial nerve stimulation|Apply tibial nerve stimulation with surface electrodes in the treatment of overactive bladder.
15796075|NCT04483817|Device|Percutaneous tibial nerve stimulation|Apply tibial nerve stimulation with surface electrodes in the treatment of overactive bladder.
15796076|NCT04483804|Combination Product|Endocrine therapy|Endocrine therapy
15796077|NCT04483778|Biological|second generation 4-1BBζ B7H3-EGFRt-DHFR|Autologous CD4+ and CD8+ T-cells lentivirally transduced to express a second generation 4-1BBζ B7H3-EGFRt-DHFR
15796078|NCT04483778|Biological|second generation 4-1BBζ B7H3-EGFRt-DHFR(selected) and a second generation 4-1BBζ CD19-Her2tG|Autologous CD4+ and CD8+ T-cells lentivirally transduced to express a second generation 4-1BBζ B7H3-EGFRt-DHFR(selected) and a second generation 4-1BBζ CD19-Her2tG
15796079|NCT04483765|Procedure|spinal anesthesia|patients undergoing transurethral resection of the prostate (TURP) and transurethral resection of the bladder (TURB) surgery under spinal anesthesia.
15796080|NCT04483752|Other|CHEST CT SCAN|Chest CTscan at 3 and 12 months
15796081|NCT04483739|Drug|Carfilzomib Lenalidomide Dexamethasone|Isatuximab-Carfilzomib-Lenalidomide-Dexamethasone (Isa-KRd) versus Carfilzomib-Lenalidomide-Dexamethasone (KRd) in newly diagnosed multiple myeloma patients eligible for autologous stem cell transplantation
15796082|NCT04483739|Drug|Isatuximab Carfilzomib Lenalidomide Dexamethasone|Isatuximab-Carfilzomib-Lenalidomide-Dexamethasone (Isa-KRd) versus Carfilzomib-Lenalidomide-Dexamethasone (KRd) in newly diagnosed multiple myeloma patients eligible for autologous stem cell transplantation
15796085|NCT04483713|Behavioral|Educational Workshop|"The workshop proposes a review of all stages of EBP which includes approaches to clinical care based on science and the quality of evidence, with the ultimate goal of promoting safe and quality care.
~The workshops comprise one for each group with a total workload of six (6) hours divided into two days, lasting three hours each day. The first day will be a theoretical approach and the second day a practical approach.
~The workshops with theoretical content and practical classes will be held in rooms of Albert Einstein Hospital.
~All participants of both educational strategies will answer the same questionnaires."
15796086|NCT04483713|Behavioral|Educational Workshop plus J. H. N. EBP Guide Tools|"In addition to the workshop. It will follow the same molds as the case of group Educational Workshop plus the Johns Hopkins Nursing Evidence-based Practice guide tools since the beginning of this practical class, when the participant will receive a description of a problem as a basis for elaborating their clinical question, and thus, move on to the next stage.
~The tools will be offered in the case of this group: question development, evidence level and quality guide, research evidence assessment tool, individual evidence tool, evidence synthesis and recommendation tool, action planning tool and tool dissemination."
15796087|NCT04483700|Drug|Filgotinib|Tablets administered orally once daily
15796088|NCT04483700|Drug|Placebo to Match Filgotinib|Tablets administered orally once daily
15796089|NCT04483687|Drug|Filgotinib|Tablets administered orally once daily
15796090|NCT04483687|Drug|Placebo to Match Filgotinib|Tablets administered orally once daily
15796091|NCT04483674|Drug|50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide|"Patients will be administered one pill of 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide daily for 48 weeks with regular check-ups at weeks 4,8,12,24 and 48 including:
~complete physical examination
~register concomitant medication
~blood test
~concomitant medications
~assessment od adverse events
~assessement of compliance
~PSQI and CESTA questionnaire (week 4 and 48)
~Recommendation in contraception methods
~Stool sample and pregnancy test urine (week 0 and 48)
~The total of blood required for each visit is 30ml except the visit of week 48 (90ml) The total of urine required is 6 mL"
15796092|NCT04483648|Other|Exercise|Home exercises were performed three times in a week for six weeks. Home exercises included range of motion exercises, coordination exercises and strengthening exercises. Repeats and durations of the exercises increased every week to provide progression.
15796093|NCT04483635|Dietary Supplement|Placebo|Weekly oral dose of placebo
15796094|NCT04483635|Dietary Supplement|Vitamin D|Weekly oral dose of Vitamin D
15796095|NCT04483609|Other|Questionnaire administration pre test|After the translation and cultural adaptation of the SF-Qualiveen scale is completed, face-to-face pre-test will be performed on 10 patients with multiple sclerosis.
15796096|NCT04483609|Other|Questionnaire administration validation and reliability|After the pre-test is completed, if necessary, arrangements will be made, and then the validity and reliability of SF-Qualiveen will be made in 80 individuals with Multiple Sclerosis.First of all, participants will be asked to complete two questionnaires (SF-Qualiveen and Urinary Distress Inventory). Two weeks after this assessment, they will be asked to respond to SF-Qualiveen again.
15796188|NCT04482764|Drug|Valproic Acid|Treatment of children with frequent cyanotic breath holding spells (at least 4 spells per week) with 5 mg/kg/day for 6 months.
15797287|NCT04473716|Drug|Cisplatin|Inductive therapy with Cisplatin of 75mg/m2, iv, qd, on day 1, 22
15796097|NCT04483596|Drug|melatonin effect on the Abbreviated Mental Test|"Questionnare
~Age
~Time (to nearest hour)
~Address for recall at end of test (Ask patient to repeat the address to ensure it has been heard correctly)
~Year
~Name of hospital
~Recognition of two persons (e.g. doctor, nurse)
~Date of birth
~Year of any famous event e.g: the last Egyptian revolution
~Name of the present monarch
~Count backwards from 20 to 1"
15796098|NCT04483583|Drug|Ticagrelor 60mg|Patients will be administered a 180 mg loading dose followed by a 60 mg bid for the duration of the study.
15796099|NCT04483583|Drug|Clopidogrel|Patients will be administered a 600 mg loading dose followed by a 75 mg daily for the duration of the study.
15796100|NCT04483570|Procedure|Redo-tethering operation|
15796101|NCT04483544|Drug|pembrolizumab|PD-1 inhibitor pembrolizumab, 200mg intravenously (IV) every 3 weeks
15796102|NCT04483544|Drug|olaparib|PARP inhibitor olaparib 300 mg orally, twice daily (BID)
15796103|NCT04483531|Drug|Odevixibat|A4250 is a small molecule and selective inhibitor of IBAT
15796104|NCT04483505|Drug|Combination, Rogaratinib + palbociclib + fulvestrant|"Patients will receive rogaratinib, palbociclib and fulvestrant in cycles of 28 days.
~Escalation Dose will follow a classic 3+3 schedule.The planned dose-levels are as follows:
~Level 1: Rogaratinib 400 mg PO BID + standard fulvestrant 500 mg every 2nd weeks until the start of the 2nd cycle, becoming every 4 weeks + palbociclib 100 mg PO per day until day 22 followed by a 7-day rest, escalable to 125 mg per day in cycle 2 (N = 3 patients).
~Level 2: Rogaratinib 600 mg PO BID + fulvestrant 500 mg IM every 2nd weeks until the start of the 2nd cycle, becoming every 4 weeks + palbociclib 100 mg PO per day until day 22 followed by a 7-day rest, escalable to 125 mg per day in cycle 2 (N = 6 patients).
~Treatment will continue until disease progression."
15796105|NCT04483492|Drug|Caffeine citrate|diaphragm contractility after administration
15796106|NCT04483479|Drug|Active Investigational Treatment ENT-01|ENT-01 will be administered in tablet form, once daily in escalating doses followed by a fixed-dose for 12 weeks.
15796107|NCT04483466|Drug|Methotrexate|Methotrexate is vibrant yellow-orange colored powder with physical properties of near insolubility in water formulated into methotrexate tablets containing an amount of methotrexate sodium equivalent to 2.5 mg of methotrexate and are round, convex, and yellow. The chemical name is N-[4-[[(2,4-diamino-6pteridinyl)methyl]methyl amino]benzoyl]-L-glutamic acid. Methotrexate is an anti-metabolite that is a folate antagonist that inhibits lymphocyte proliferation and functions as an immunosuppressant in arthritis.
15796108|NCT04483466|Drug|Placebo|Placebo
15796109|NCT04483453|Other|EXPL feeding regimen|EXPL FUF (lower protein and 100% lactose) + EXPL IC (whole grains and legumes)
15796110|NCT04483453|Other|CTRL feeding regimen|CTRL FUF (standard protein content and carbohydrate profile) + CTRL IC (refined grains)
15796111|NCT04483440|Biological|4D-110|4D-110 drug product developed for gene therapy which comprises an AAV capsid variant (4D-R100) carrying a transgene encoding a codon-optimized human CHM gene.
15796112|NCT04483427|Combination Product|Nalbuphine, ketorolac, accufuser|multimodal analgesic regimen consisting of nalbuphine combined with ketorolac using IV continuous infusion silicon device (Accufuser)
15796113|NCT04483414|Drug|68Ga PSMA-11 injection|Injection of 68Ga PSMA-11
15796114|NCT04483414|Procedure|Positron Emission Tomography/Computed Tomography|PET/CT scan after 68Ga PSMA-11 injection
15796115|NCT04483401|Behavioral|Cognitive Orientation to Occupational Performance (CO-OP)|"Intervention: CO-OP is a cognitive approach to solving functional motor problems (Polatajko et al., 2001b). Therapists teach children a global problem solving strategy (Goal-Plan-Do-Check) as a framework for developing specific strategies for overcoming motor problems; these strategies are determined after a dynamic performance analysis by the therapist to determine where the breakdown is in performing the task. CO-OP intervention will be administered by occupational therapists who have been trained in the CO-OP approach. Children will be seen once weekly for one hour over 12 weeks at as per published protocol (Polatajko et al., 2001b). Parents or caregivers will be encouraged to attend treatment sessions so that therapists can instruct them how to facilitate strategy use between treatment sessions. Children will select three functional motor goals to be addressed over the course of treatment, rating their performance and satisfaction of these goals pre- and post-intervention."
15796116|NCT04483388|Other|Training with Virtual Reality|Computed virtual reality therapy was performed using the Nintendo Wii® console equipment. This system allows interaction with the player by means of a movement detection system and the representation of his avatar graphical representation of a user in virtual reality. It has a remote control with a wireless system, responsible for capturing the speed, direction , acceleration and deceleration of movement. The movements performed by the player are captured and reproduced on a screen via an infrared light sensor, positioned above the TV. The feedback given by the TV provides the movement itself observing opportunity in real time, generating positive reinforcement and facilitating training and improved task. The software used in this study was the Nintendo Wii Sports.
15796117|NCT04483388|Other|Conventional Training|"It was done five types of exercises following to the protocol:
~Exercise 1 (shoulder abduction); Exercise 2 (external rotation of the shoulder); Exercise 3 (elbow extension); Exercise 4 (weight transfer in upper limbs: a sitting position); Exercise 5 (function: task-oriented training)."
15796118|NCT04483375|Biological|SCTA01|recombinant humanized anti-SARS-CoV-2 monoclonal antibody
15796119|NCT04483375|Other|Placebo|Placebo
15796120|NCT04483362|Behavioral|Complex physical activity intervention|"Structured weekly sessions with a Physiotherapist over an 8 week period, including:
~Evaluation of current levels of physical activity and physical function - including discussion of results
~Education regarding the importance of physical activity
~Supervised physical activity session with a physiotherapist
~Structured weekly sessions applying behavioural change techniques which aim to increase participation in physical activity. Sessions include: provision of activity monitor (Fitbit Inspire), goal setting, monitoring, collaborative problem solving and action plan implementation. Intervention includes additional time allowance of 1 hour per week to assist in implementing action plan items"
15796121|NCT04483349|Other|Survey Administration|Complete survey
15796122|NCT04483336|Other|Virtual Reality Distraction|Virtual reality goggles are commercially available wearable devices that are used to view view videos and play video games three dimensionally.
15796123|NCT04483336|Other|TV Screen Distraction|A cartoon video was played on a regular TV screen.
15796189|NCT04482751|Drug|Corifollitropin alfa|AMH will be measured during ovarian stimulation with corifollitropin alfa
15796124|NCT04483323|Procedure|Erector Spinae Plane Block|"The patient will be placed in the lateral position. Following skin disinfection, counting down from the C7 spinous process and using ultrasound guidance, the level of T2 transverse process will be identified. A 2-5 MH2 curved array transducer (sono site Edge, Bothell, Will behington) will be positioned transversely to visualize the lateral tip of T2 transverse Process. A longitudinal parasagittal orientation will be obtained over the transverse process using a 22 - gauge 8 cm block needle (visioplex, Vygon , France) will be inserted in plane to US beam in a caudal to cranial direction to place the needle tip between the posterior fascia of the erector spinae muscle and the T2 transverse process.
~Position of the needle tip in the ESP deep to the erector spinae muscle will be confirmed using hydrodissection with 0.5 - 1 ml of normal saline and visualization of the linear fluid spread deep to the erector spinae muscle following which 20 ml of 0.25% bupivacaine will be injected."
15796125|NCT04483323|Procedure|Intraarticular Injection|Intraarticular injection of local anesthetic through the surgical port
15796126|NCT04483310|Behavioral|MR therapy.|MR therapy is based on 4 steps applied directly during the attack: Step I: Reappraisal of the meaning of the attack; Step II: psychological and emotional distancing; Step III: inward focused-attention meditation; Step IV: Muscle relaxation.
15796127|NCT04483310|Behavioral|breathing-distraction exercise|The control intervention is based on a breathing exercise, the patients should entail slow deep breaths, while repeatedly counting from 1-10
15796128|NCT04483297|Drug|AK1320 MS|AK1320 MS + Local Autologous Bone + Posterior Fixation. Ascending Dose.
15796129|NCT04483297|Other|Control|Local Autologous Bone + Posterior Fixation
15796130|NCT04483284|Drug|TACE combined with Camrelizumab|Camrelizumab(200mg q3w ivgtt) combined with TACE
15796131|NCT04483284|Procedure|TACE plus Camrelizumab|Camrelizumab(200mg q3w ivgtt) combined with TACE
15796132|NCT04483271|Dietary Supplement|300 mg of omega3-FA|"The participant will receive 1,000 mg of wild salmon and fish oil complex once daily, which contains 300 mg of omega3-FA.
~Baseline and follow-up serum levels of IL-1,IL-6, and TNF will be measured."
15796133|NCT04483258|Procedure|Sedation with sevoflurane insufflation|Induction with %8sevoflurane after adequate sedation reducing %3
15796134|NCT04483258|Procedure|intravenous sedation|midazolam +ketamine + atropine
15796135|NCT04483245|Biological|Blood sampling|Blood sampling
15796136|NCT04483232|Biological|Ear canal swab|Ear canal swab
15796137|NCT04483219|Drug|TKI ± anti-PD-1 antibody|"After one cycle of TKI, evaluations would be performed according to RECIST v 1.1. (1) obvious response (A): CR, PR or shrunken SD, or cavitation in metastatic lung lesions, or decrease in the density of liver metastatic targets ≥15%; (2) general response (B): enlarged SD; (3) poor response (C): PD. TKI ＋ anti-PD-1 antibody will be administered in group A. The subjects in group C will exit the study. The subjects in group B will continue TKI for another one cycle, the obvious response subjects will entered group A, the general response subjects will keep in arm B and continue the TKI monotherapy, and the poor response subjects will exit the study.
~Fruquintinib 5mg or regorafenib 120mg, qd po, 3 weeks, Q4w. (The investigators decide to choose fruquintinib or regorafenib)
~Toripalimab injection 240mg, Q3w, until the disease progresses or lasts for two years."
15796138|NCT04483206|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo ASCT
15796139|NCT04483206|Drug|Melphalan|Given IV
15796140|NCT04483206|Other|Questionnaire Administration|Ancillary studies
15796141|NCT04483193|Diagnostic Test|Duplex ultrasound|Point-of-Care compression ultrasound test combined with colour doppler imaging in the range from the groin to the popliteal region of both lower extremities.
15796142|NCT04483180|Other|Comparison of sweetener blends in liquid form (cross-over study)|The aim is to compare the effects of different sweetener blends on glycemia, subjective appetite parameters and safety parameters when consumed in a beverage as part of a breakfast
15796143|NCT04483167|Drug|99mTccAbVCAM1-5 injection|intravenous injection of 99mTccAbVCAM1-5 with dose increase
15796144|NCT04483154|Device|Coala Heart Monitor|The Coala Heart Monitor (Coala Life AB, Sweden) is a CE and FDA-cleared device for real-time, remote monitoring of 2-lead ECG as well as heart and lung sounds. The Coala Heart Monitor automatically detects for 9 of the most common arrhythmias and has an integrated stethoscope for remote auscultation. It is paired wirelessly with the patient's smartphone and results are provided instantly both to patient and to connected provider in the cloud-based Coala Care portal.
15796145|NCT04483141|Diagnostic Test|Abbey Pain Scale|Hetero-assessment of pain
15796146|NCT04483128|Device|Electrical stimulation: Interferential Current (IFC): Experimental Group|"Application of IFC with Sonopuls 692® (Enraf-Nonius BV, Rotterdam, The Netherlands) device. Parameters:
~Carrier frequency of 4000 Hz
~Amplitude modulated frequency of 65 Hz (AMF)
~Sweep frequency of 95 Hz of modulation with a 1:1 swing pattern, in a quadripolar technique.
~Intensity will depend on subjet's tolerance but without generate visible muscle twitches.
~Session duration: 25 minutes"
15796147|NCT04483128|Device|Electrical stimulation: Interferential Current (IFC): Control Group|"Application of IFC with Sonopuls 692® (Enraf-Nonius BV, Rotterdam, The Netherlands) device. Parameters:
~Carrier frequency of 4000 Hz
~Amplitude modulated frequency of 65 Hz (AMF)
~Sweep frequency of 95 Hz of modulation with a 1:1 swing pattern, in a quadripolar technique.
~NO intensity (0 mA)
~Session duration: 25 minutes"
15796151|NCT04483102|Device|Declined liver in Normothermic Machine Perfusion (NMP)|The discarded livers rejected by all other centers and meeting pre-NMP eligibility criteria will receive NMP using the OrganOx® metra device. The NMP-treated liver that meets the viability criteria will be transplanted to patients who are eligible and consented to the study.
15796185|NCT04482803|Drug|Carbon nanoparticles suspension injection will be injected into or around the cortex of the clinically assessed positive lymph nodes|Before NST, one of the clinically assesed positive lymph nodes will be subjected to ultrasound-guided CNB or FNA, and a locating clip (Ultraclip, BARD) will be placed. Meanwhile, a small amount of Kanarine (carbon nanoparticles suspension injection, 0.5ml:25mg, H20073246) will be injected into or around the cortex of the locating lymph node and other clinically assessed positive lymph nodes. Preoperative FNA will be performed again for locating clip labelled node.
15796186|NCT04482790|Procedure|Conventional celluloid matrix technique in management of black triangle|conventional restorative technique in management of black triangle
15796152|NCT04483102|Procedure|Standard cold preservation of liver|"The study will have three comparison groups - one local comparison group and two comparison groups from the national UNOS data.
~Comparison group 1 will be patients who received a standard liver transplantation and follow-up care at the Washington University/ Barnes Jewish Hospital (n=50). Patients will be matched by a 5-year age category, sex, MELD score, donor liver graft type (e.g., DCD, DBD), donor age (5-year category), and donor sex. Washington University/ Barnes Jewish Hospital maintains a liver transplantation database that prospectively collects pre- and post-transplantation patient data.
~Comparison group 2 will be patients who received DBD liver transplantation in the OPTN/UNOS database (n=100). Patients will be matched by age, sex, MELD score, donor age, and donor sex.
~Comparison group 3 will be patients who received DCD liver transplantation in the OPTN/UNOS database (n=100). Patients will be matched by age, sex, MELD score, donor age, and donor sex."
15796153|NCT04483089|Device|Transcatheter heart valve procedure|Transcatheter treatment of TR with Abbott TriClip™.
15796154|NCT04483076|Drug|Chemotherapy drug|The preoperative SOX chemotherapy consists of three-week cycles of intravenously administered oxaliplatin 130 mg/m2 on day 1 and orally administered S-1 40-60 mg twice a day (BID) on day 1 to 14. The dose of S-1 depends on body surface area (BSA): 40mg BID for BSA < 1.25 m2; 50mg BID for 1.25 m2 < BSA <1.5 m2; 60mg BID for BSA > 1.5 m2. Day 15 to day 21 is the rest period.
15796155|NCT04483076|Procedure|Gastrectomy|Surgery is planned 3-4 weeks after the last cycle of chemotherapy. A standard D2 radical laparoscopic gastrectomy is recommended. The extent of gastric resection and lymphadenectomy were performed as per the treatment guidelines. Reconstruction after gastrectomy was decided by the surgeon. All operations are performed by well trained and experienced surgical team to guarantee the quality of surgery, including harvesting more than 16 lymph nodes.
15796156|NCT04483076|Procedure|Laparoscopic exploration|Laparoscopic exploration is to detect occult peritoneal metastases and inspect the primary lesion, liver, diaphragm, pelvic organs, bowel and omentum according to the standard acquirements reported before. Patients with any patterns of distant metastases, suggestive of distant metastasis (M1), will be excluded from the trial.
15796157|NCT04483063|Drug|2% chlorhexidine gluconate skin cleanser|2% chlorhexidine gluconate skin cleanser over shoulder region before shoulder surgery
15796158|NCT04483050|Device|Hip protection orthosis|Experimental group would wear hip protection orthosis over 12 hours a day for 1 year.
15796159|NCT04483037|Drug|Bowklean|assigned intervention
15796160|NCT04483024|Dietary Supplement|Collagen hydrolysate and chicken extract|One bottle (68mL) of collagen hydrolysate (2g) in chicken extract taken daily in the morning after meal for 24 weeks
15796161|NCT04483011|Dietary Supplement|RiaGev|Dietary supplementation
15796162|NCT04482998|Other|No intervention - retrospective study|No intervention - retrospective study
15796163|NCT04482985|Drug|Meclizine Hydrochloride|Meclzine is given to all study participants to prevent seasickness. Meclizine plasma levels are determined from both the meclizine responders and non responders group.
15796164|NCT04482972|Procedure|DCB|Angioplasty with DCB is an angioplasty technique which allows drug delivery to the coronary artery without stent implantation.
15796165|NCT04482972|Procedure|DES|Angioplasty with DES is an angioplasty technique which permits drug delivery to the coronary artery and permanent implantation of a stent.
15796166|NCT04482959|Drug|Carbetocin|(1-deamino-1-monocarba-(0-2-methyltyrosine)-oxytocin) is a long-acting synthetic agonist analogue of the human oxytocin
15796167|NCT04482959|Drug|Sodium chloride 0.9%|Physiological solution will be used as placebo
15796168|NCT04482946|Diagnostic Test|Assessment of fluid responsiveness|The positive end-expiratory pressure test (PEEP-test) consisted of a transient increase of PEEP from 5 to 20 cm H2O for 120 seconds. The PEEP-test was interrupted if MAP decreased below 55 mm Hg and/or pulse contour cardiac index (PCCI) decreased below 1.5 L/min/m2. Mini-fluid challenge test (mFCT) consisted of rapid infusion of crystalloids 1.5 mL/kg during 120 seconds. Thereafter, all patients received fluid challenge (standard fluid challenge test, sFCT). During the sFCT, patients received 7 mL/kg of crystalloids within 10 minutes. Investigators performed monitoring of mean arterial pressure (MAP), SVV and PPVPiCCO using femoral artery (PiCCO2). Investigators also assessed PVVNK using radial artery and Nihon Kohden patient monitor. HLI (Hamilton G-5, Switzerland) and PVI (Masimo, USA) were assessed non-invasively, using finger probes.
15796169|NCT04482933|Drug|Biological G207|Single dose of HSV-1 (G207) infused through catheters into region(s) of tumor defined by MRI
15796170|NCT04482920|Diagnostic Test|p-aminohippurate clearance study|To measure kidney blood flow, small doses of a substance called p-aminohippurate (PAH) are used.
15796171|NCT04482920|Diagnostic Test|Iohexol infusion|To measure glomerular filtration rate (GFR)
15796172|NCT04482907|Dietary Supplement|Giving dill by mouth capsule to the study group and placebo capsule by mouth to the control group.|Tests from intravenous blood: TSH, fT3, fT4, anti-TPO, Anti-Tg, CRP
15796173|NCT04482894|Other|Palliative Care Visits|Regular visits with a palliative (supportive) care specialist
15796174|NCT04482881|Drug|Isosorbide Mononitrate 40 MG|giving women isosorbide mononitrate 40 MG
15796175|NCT04482881|Drug|Isosorbide Mononitrate 60 MG|giving women isosorbide mononitrate 60MG
15796176|NCT04482881|Drug|Misoprostol|Giving women misoprostol
15796177|NCT04482868|Procedure|Percutaneous screw fixation through K-wire-assisted reduction and maintenance|Percutaneous screw fixation for acute scaphoid fractures through K-wire-assisted reduction and maintenance
15796178|NCT04482855|Device|Low-level laser|Low-level laser therapy
15796179|NCT04482842|Device|Gene detection (CYP2C9*3, VKORC1)|Warfarin is administered at the recommended dose by detecting CYP2C9*3 and VKORC1 gene polymorphismsand. The doctor adjusts the dosage according to the fluctuation of INR value in time.
15796180|NCT04482842|Drug|Warfarin Sodium|Warfarin is administered at a gene-guided dose or at a regular dose.
15796181|NCT04482829|Drug|Jing-yan-kang Granule|Jing-yuan-kang granule will be administered 6 days on and 1 days off for 12weeks.
15796182|NCT04482829|Drug|PC chemotherapy and symptomatic treatment|"Drugs used in PC chemotherapy includes Pemetrexed and Cisplatin. Pemetrexed disodium for injection 500 mg per square meter, intravenous drip on day 1 in each treatment cycle.
~Cisplatin injection 75 mg per square meter, intravenous drip from day 1 to day 3 in each treatment cycle. One treatment cycle will be continued for 21 days and 4 cycles will be performed.
~If necessary, symptomatic treatment will also be used."
15796183|NCT04482816|Device|Physiological pacing|Pacing of the his bundle or the left bundle branch
15796190|NCT04482738|Other|High-calorie meal|Intake of a high-calorie meal (2500-3000 calories) within 15 minutes.
15796203|NCT04482712|Drug|Rapamycin|Daily administration of a dose of investigational drug for up to 4 weeks while hospitalized
15796204|NCT04482712|Drug|Placebo|Administration of investigational drug placebo for up to 4 weeks while hospitalized
15796205|NCT04482699|Biological|RAPA-501-Allo off-the-shelf Therapy of COVID-19|Allogeneic off-the-shelf RAPA-501 cells
15796206|NCT04482699|Other|Placebo|RAPA-501-Allo cell placebo
15796212|NCT04482673|Drug|Daily Vitamin D3|6000 IU vitamin D3 daily
15796213|NCT04482673|Drug|Daily placebo|Placebo daily
15796214|NCT04482673|Drug|Bolus vitamin D3|Bolus 20,000 IU vitamin D3 daily for 3 days
15796215|NCT04482673|Drug|Bolus placebo|Bolus placebo daily for 3 days
15796216|NCT04482660|Procedure|Positron emission tomography with 18F-RO6958948|tau PET ()
15796217|NCT04482647|Other|Media Intervention|View instructional video
15796218|NCT04482647|Procedure|Meditation Therapy|Perform meditation
15796219|NCT04482647|Other|Quality-of-Life Assessment|Ancillary studies
15796220|NCT04482647|Other|Questionnaire Administration|Ancillary studies
15796221|NCT04482647|Procedure|Yoga|Perform breathing techniques
15796222|NCT04482634|Other|Remote controlled exercise|Breathing, aerobic, posture, stretching, upper and lower extremity strengthening exercises.
15796223|NCT04482634|Other|Home exercise|Breathing, aerobic, posture, stretching, upper and lower extremity strengthening exercises.
15796224|NCT04482621|Drug|Decitabine|"Study duration is 6 weeks after the last dose of study drug. Number of study visits is dependent on Length of hospitalization of study participant. Study visits are scheduled on days 0-7, 11, 15, 29, and may occur via telemedicine or inpatient assessment or outpatient assessment in COVID recovered participants.
~Decitabine will be administered via Intravenous Administration 10/mg/m^2/day Dosage: 10mg/m^2/day IV day x 5 days (1 cycle only)"
15796225|NCT04482621|Other|Placebo Saline|Saline based placebo will be administered via Intravenous injection. Dosage Regimen: 10mg/m^2/day IV day x 5 days (1 cycle only)
15796226|NCT04482595|Drug|BIO 300 Oral Suspension|Suspension of genistein nanoparticles
15796227|NCT04482595|Drug|Placebo|Matched placebo for BIO 300 Oral Suspension
15796228|NCT04482582|Radiation|Cryoneurolysis|Patients will be offered a minimally invasive solution known as cryoneurolysis. By directly applying a cold cryoneurolysis probe to the nerves the axon is destroyed, resulting in Wallerian degeneration of the distal nerve without distorting epineurial or perineurial tissue. Application of cryoneurolysis will help reduce the amount of narcotics the patient would need to take and instead provide them longer term pain control with minimal risk.
15796229|NCT04482582|Other|Standard of Care|Patients will be provided regular standard of care at the Stanford Hospital with long-term follow-up provided at the Stanford Center for Reconstruction after Chest Wall Injury.
15796230|NCT04482569|Drug|XNW4107|Single or multiple dose ascending study for XNW4107 alone or multiple dose study of XNW4107 in combination with imipenem/cilastatin
15796231|NCT04482556|Device|Q-NRG+ Indirect Calorimetry Device|The two indirect calorimetry devices will be tested in an alternating fashion for each enrolled patient. Each enrolled patient subsequently will alternate in which device is tested first.
15796232|NCT04482556|Device|V(max) Encore Indirect Calorimetry Device|The two indirect calorimetry devices will be tested in an alternating fashion for each enrolled patient. Each enrolled patient subsequently will alternate in which device is tested first.
15796233|NCT04482543|Drug|Methotrexate|Intra-silicone oil injection of 250 µg methotrexate is done at the end of surgery and is repeated at weeks 3 and 6 postoperatively.
15796234|NCT04482530|Other|fruit paste matrice|Evaluation of the kinetics of the appearance of nutrients and the metabolic response induced by the consumption of fruit pastes (5 different matrices will be tested: 1 Original recipe, 1 maltodextrine recipe, 1 fructose recipe, 1 isomaltulose recipe and 1 mixed recipe comprising fructose and isomaltulose) in elderly healthy volunteers.
15796235|NCT04482517|Other|Density Gradient Centrifugation|Semen processing is done by double layer density gradient method.
15796236|NCT04482517|Other|Physiological ICSI|Sperm selection by PICSI dishes depending on hyaluronan binding of sperm head
15796237|NCT04482517|Other|Magnetic activated cell sorting|Sperm selection by using Annexin V micro-beads and separation columns
15796238|NCT04482517|Other|Testicular sperm|Using testicular sperm retrieved by TESA or TESE
15796239|NCT04482504|Diagnostic Test|3 tests: Posturography, Questionnaire, vitamin D|Posturography platform Kistler 9281B Questionnaire focused on exercise activities and self-evaluation of postural stability The investigators also determine level of vitamin D in the blood.
15796240|NCT04482491|Procedure|Endoscopic Submucosal Dissection|Endoscopic Submucosal Dissection
15796241|NCT04482478|Dietary Supplement|Extract of Dolichos lablab Linne (EDL)|Investigational product (EDL): once a day, 2 tablets orally intake (Extract of Dolichos lablab Linne 715 mg/day)
15796242|NCT04482478|Other|Placebo oral tablet|Placebo: consumed in the same way as the investigational product
15796243|NCT04482465|Diagnostic Test|blood sample|blood sample to determine omega6/omega 3 ratio, EPA, DHA, zinc, cupric oxide, vitamine D
15796244|NCT04482452|Procedure|Colonoscopy|Diagnostic colonoscopy will be performed
15796245|NCT04482439|Device|Vivity Extended Depth of Focus intraocular lens (IOL)|Bilateral implantation of the Vivity lens after cataract surgery, with slight myopia planned in the non-dominant eye.
15796246|NCT04482413|Drug|AstroStem and Donepezil Placebo|Autologous adipose tissue derived mesenchymal stem cells (AdMSCs) and Donepezil Placebo
15796247|NCT04482413|Drug|Donepezil and AstroStem Placebo|Active control group receive 5 mg of Donepezil every 4 weeks from Week 0 to Week 16.
15796248|NCT04482400|Behavioral|NEAT!2|8 week sedentary reduction program
15796249|NCT04482400|Behavioral|MyKneeGuide|8 week surgery recovery education program
15796250|NCT04482387|Device|DigiVis visual acuity app|Self-testing of visual acuity app on two occasions
15796251|NCT04482361|Diagnostic Test|Presence of specific anti-SARS-CoV-2 antibodies|Presence of specific anti-SARS-CoV-2 antibodies
15796252|NCT04482348|Other|Explanation|Explanation provided to patients for more pain than expected
15796253|NCT04482335|Other|No intervention|No intervention
15796254|NCT04482309|Drug|Trastuzumab deruxtecan|Trastuzumab deruxtecan by intravenous infusion
15796255|NCT04482296|Drug|SSRI with Zinc Sulfate|Zinc sulfate (30 mg) once daily for 8 weeks SSRI
15796256|NCT04482270|Drug|fezolinetant|Oral
15796257|NCT04482257|Drug|Irinotecan Liposome Injection combined with 5-FU/LV|Drug: Irinotecan Liposome Injection 70mg/m2 (CSPC) combined with 5-FU/LV; Drug: Irinotecan Liposome Injection 70mg/m2 (Ipsen, ONIVYDETM) combined with 5-FU/LV;
15796258|NCT04482244|Drug|Cannabidiol|Liquid taken orally
15796259|NCT04482244|Other|Placebo|Liquid taken orally
15796260|NCT04482192|Combination Product|Thoracic paravertebral block|After ending pulmonary procedure, a pleural pouch created beside vertebral column, a catheter is inserted to the pouch for continuous infusion of 1% lidocaine for 3 postoperative days. Intravenous morphine sulfate (0.05mg/kg) was given as a rescue medication if the VAS ≥ 4.
15796261|NCT04482192|Drug|Systemic analgesia|Systemic analgesia (SA) group receive 1gm paracetamol and 30 mg ketorolac by intravenous infusion every 6 hours for 3 days. Intravenous morphine sulfate (0.05mg/kg) was given as a rescue medication if the VAS ≥ 4.
15796262|NCT04482179|Device|Active TMS|Active TMS will be delivered at 100% motor threshold
15796263|NCT04482179|Behavioral|CILT|60-90 minutes of CILT will be administered during each treatment session
15796264|NCT04482179|Device|Sham TMS|Sham TMS will be administered
15796265|NCT04482166|Other|Training|20-times training of fiberoptic-guided tracheal intubation through supraglottic airway device to pediatric airway manikin
15796266|NCT04482166|Device|supraglottic airway device|supraglottic airway device
15796267|NCT04482153|Device|fibroscan|The Controlled Attenuation Parameter (CAP) can using transient elastography (TE) (Fibroscan®) permits to efficiently separate different grades of severity of steatosis. CAP is based on the properties of ultrasonic signals acquired by the Fibroscan®. It allows to simultaneously measure liver stiffness and CAP in the same liver volume.
15796269|NCT04482127|Other|SubEpithelial connective graft|Connective tissue graft harvested from hard palate, to be placed buccal to extraction sockets in the intervention group
15796270|NCT04482114|Radiation|ULD CT|All the examinations are part of the routine care. Addition of the ULD CT protocol does not require injection of contrast agent and does not extend the duration of the examination.
15796271|NCT04482101|Other|Root canal obturation|Root canal filling
15796272|NCT04482088|Behavioral|Occupational Therapy in an Equine Environment|10 weeks of occupational therapy in an equine environment aimed at improving individual goals related to self-regulation, social communication, and play
15796273|NCT04482088|Behavioral|Occupational Therapy in a Clinic (OTC)|10 weeks of occupational therapy in a clinic aimed at improving individual goals related to self-regulation, social communication, and play
15796274|NCT04482075|Other|segmental stability training|SEGMENTAL STABILISATION TRAINING (SST): This part of the therapy shall involve Isometric co-contraction of Lumbar Transversus abdominis and Lumbar Multifidus. The patient shall perform 10 repetitions of abdominal drawing-in manoeuvre with 30-40% Maximal Voluntary Contraction (MVC) with a 10-second hold in specific prescribed positions.
15796277|NCT04482036|Other|Mobile Phone Application Assessments|"The BrainCare Notes app was designed to be installed on the caregiver's phone. It has the capacity to send Neuropsychiatric Inventory Questionnaire (NPI-Q) assessments to the caregiver. If the answers to the behavioral and psychological symptoms rise above the threshold, the clinicians will be notified, and a care plan will be enacted, in order to keep the patient and caregiver safe.
~The application also has the ability to send and receive private messages between caregiver and the patient's clinical care team."
15796278|NCT04482036|Other|Standard Assessments|The caregiver and patient will receive the same questionnaires and surveys that the intervention group will receive. However, they will not receive the mobile phone application questionnaires.
15796279|NCT04482023|Behavioral|Training video on anxiety, fear and loneliness in the COVID-19 environment.|Video with the actions identified as essential to address the diagnosis of anxiety, fear and loneliness in the environment COVID-19 identified by a group of experts.
15796308|NCT04481776|Other|Breakfast omission|No breakfast consumed across seven days
15797367|NCT04472949|Drug|Durvalumab|Durvalumab: 1500 mg iv
15796280|NCT04482010|Other|Local community-based HIV care|"Compared to the classic HIV care, community-based HIV care includes:
~Individual interviews with a psychosocial agent;
~Support groups conducted by psychosocial agents;
~Culinary workshops gathering PLWHIV and healthcare professionals;
~Home visits by a community worker;
~Emergency relief based on a funding for patients with urgent needs
~As in the classic HIV care, ARCAD Santé PLUS provides consultations with doctors, prescriptions and delivery of antiretroviral (ARV) treatment every 3 months, biological analyses for enrolment, and follow-up every 6 months. In addition, psychosocial agents from ARCAD Santé PLUS propose workshops on education and support for adherence to treatment."
15796282|NCT04481984|Other|Home-based Hand exercise|"Isometric exercise; patients squeezed a hand exercise ball for 60 seconds. This exercise repeated 15-times/3 set per day.
~Stretching exercises; self-administered stretching exercises were as follows; i) forearm supination and pronation, ii) wrist flexion and extension, iii) finger flexion, extension, and abduction iv) thumb flexion, extension, and abduction. These exercises repeated 10-times/2 set per day."
15796283|NCT04481984|Other|Care advice|Patients received care advice including avoiding cold exposure and trauma.
15796284|NCT04481971|Drug|Prednisolone|Tablets
15796285|NCT04481971|Drug|lactose in capsules gelatin|Tablets
15796286|NCT04481958|Behavioral|I-PROTECT|The I-PROTECT model is based on existing research and knowledge of experts in sport medicine, sport psychology and implementation science, with the involvement of end-users throughout the process. The interdisciplinary intervention includes exercises based on physical and psychological principles of effective injury prevention training, specifically tailored for youth handball players, and support for developing a continuous implementation strategy. The intervention is delivered through a mobile application (the I-PROTECT GO), including modules tailored for coaches, players, club administrators, and caregivers, respectively. Coaches are introduced to the intervention in a workshop, and they will conduct the exercises with their teams during handball practice. Players will have support for conducting exercises on their own, and club administrators for developing an implementation strategy. Caregivers will have access to tailored information about injury prevention training.
15796287|NCT04481945|Drug|bioceramic sealer|pre-mixed bioceramic obturation material. It is dispensed using a syringe in cases of root canal obturation and with either a syringe or as a putty when doing root repair and retrograde fillings.
15796288|NCT04481932|Drug|Trastuzumab combined with Pyrotinib and chemotherapy|"Pyrotinib is a small molecule, irreversible tyrosine kinase inhibitor with targets of epidermal growth factor receptor 1 (EGFR/HER1/ErbB1), human epidermal factor receptor 2 (HER2/ErbB2/Neu) and human epidermis Factor Receptor 4 (HER4/ErbB4).
~As a new generation of anti-HER2 therapeutic targeted drugs, pirotinib covalently binds to the ATP binding sites of the kinase regions of EGFR, HER2 and HER4 in cells to prevent homogeneity and heterogeneity of EGFR, HER2 and HER4 in tumor cells Dimer formation, inhibiting its own phosphorylation, blocking the activation of downstream signaling pathways, thereby inhibiting tumor cell growth"
15796289|NCT04481919|Drug|Protocolized diuretic therapy|The urine sodium, urine creatinine and serum creatinine results will be input into the diuretic calculator and the diuretic dose will be chosen based on daily goals for urine output and net negative fluid balance.
15796290|NCT04481906|Procedure|Vaginal mesh for female cystocele|Vaginal mesh procedures (e.g. Perigee) were susgested for women with POP-Q stage III or more cystocele
15796291|NCT04481893|Behavioral|Use of a virtual reality headset|"The intervention will consist of 2 sessions of 30 minutes each, based on the use of a virtual reality headset with the AQUA® application.
~The 1st session will take place on the day of the surgical intervention, upon arrival in hospital, after reception in the room.
~The 2nd session will take place the same day, post-operatively, once the awakening is satisfactory (within 3 to 6 hours after the intervention)"
15796292|NCT04481880|Diagnostic Test|measuring IAP and respiratory parameters|Effect of IAP on respiratory parameters Correlation between IAP and Gastric and urinary bladder pressures
15796293|NCT04481867|Procedure|densah bur|osseodensification densah bur
15796294|NCT04481854|Procedure|cricoid pressure|cricoid pressure during laryngoscopy
15796295|NCT04481854|Procedure|left paratracheal pressure|left paratracheal pressure during laryngoscopy
15796296|NCT04481841|Drug|oryzanol + vitamin B2 (riboflavin) + vitamin E|"1:Control group Specific medicines and usage, course of treatment are as follows: oryzanol + vitamin B2 (riboflavin) + vitamin E, oryzanol tablets, oral, 10 mg/time, 3 times/day; vitamin B2 tablets, oral, 10 mg/time, 3 times/day; vitamin E pills, oral, 100 mg/time, 1 time/day, 1 months as a course of treatment.
~2.Therapeutic regimen of experimental group On the basis of classical Gu-Nucleus-E triple drug therapy, the experimental group was treated with head yuanshi dian therapy twice a day for 1 months as a course of treatment."
15796297|NCT04481828|Procedure|gastrectomy|gastric resection with lymph node dissection(D1+,D2) for stomach cancer.
15796298|NCT04481815|Drug|Rituximab|375mg/m2 intravenous infusion d1, every 3 weeks for 1 cycle, 6 cycles will be prescribed for induction therapy. 375mg/m2 intravenous infusion d1, every 8 weeks for 1 cycle, 4 cycles will be prescribed for maintenance therapy.
15796299|NCT04481815|Drug|Lenalidomide|25mg orally d1-10 every 3 weeks for 1 cycle, 6 cycles will be prescribed for induction therapy. 25mg orally d1-14,d29-42 every 8 weeks for 1 cycle, 4 cycles will be prescribed for maintenance therapy.
15796300|NCT04481815|Drug|Methotrexate|3.5g/m2 intravenous infusion for 4 hours in d1, every 21 days for 1 cycle, 6 cycles will be prescribed.
15796301|NCT04481802|Device|RadiaAce gel|Patients will apply the RadiaAce to the treatment area starting 5 days before radiation treatment. The Hydrogel/cream will be applied three times a day with a minimum of four hours between applications. Treatments will be used through the course of RT and for 6 days after the last fraction of radiation.
15796302|NCT04481802|Device|Biafine|Patients will apply the Biafine to the treatment area starting 5 days before radiation treatment. The Hydrogel/cream will be applied three times a day with a minimum of four hours between applications. Treatments will be used through the course of RT and for 6 days after the last fraction of radiation.
15796303|NCT04481789|Drug|MT-1186|Suspension
15796304|NCT04481789|Drug|Rosuvastatin|Tablets
15796305|NCT04481789|Drug|Sildenafil|Tablets
15796306|NCT04481789|Drug|Furosemide|Tablets
15796307|NCT04481776|Other|Breakfast consumption|Standardised breakfast consumption across seven days
15796309|NCT04481763|Drug|Camrelizumab|Camrelizumab is 200 mg iv. administered every 2 weeks for 3 cycles with radiotherapy ( 50gy, 25 times for 5weeks)
15796310|NCT04481763|Radiation|radiotherapy|radiotherapy
15796311|NCT04481750|Drug|MT-1186|Solution or suspension
15796312|NCT04481750|Drug|MT-1186-matching placebo|Solution or suspension
15796313|NCT04481737|Behavioral|Peer-delivered and Technology Support Integrated Illness Management and Recovery|PDTA-IIMR is delivered by a peer support specialist with the use of guided IIMR eModules and a smartphone application designed to complement in-person eModule sessions. The eModules are designed to be reviewed with a peer support specialist and consumer during one-hour, weekly, telephonic sessions in a community setting. Each eModule includes videos and experiential learning tasks on psychoeducation and coping skills training.
15796314|NCT04481737|Behavioral|Peer support|Peer support is a non-manualized form of social support, frequently coupled with instrumental support, that is mutually offered or provided by persons having a mental health condition to others sharing a similar mental health condition to bring about a desired social or personal change. Peer support specialists are provided with 1-hour of supervision each week
15796315|NCT04481724|Dietary Supplement|gamma-linolenic acid|3 capsules per day of GLA for 24 months
15796316|NCT04481724|Dietary Supplement|placebo|3 capsules per day of placebo for 24 months
15796317|NCT04481711|Procedure|Total Knee Arthroplasty|Osteoarthritis (OA) is one of the most common chronic peripheral joint diseases increasing among the aging population.Pathogenesis is not fully known.One of the most common risk factors and causes are loss of pain and function. Knee joint osteoarthritis adversly affects the person's life quality. Total Knee Arthroplasty (TKA) is a surgical approach to restore tibiofemoral joint alignment, especially in the severe level of knee OA.
15796318|NCT04481698|Other|Mesoglycan|Prisma® 30 mg 2 vials i.m./day for the first 5 post-operative days and then Prisma® 50 mg 1 oral tablet twice/day for an additional 30 days
15796319|NCT04481685|Drug|ATI-450|50 mg (as determined from Phase I study) per dose. (100 mg per day). Up to a maximum of 14 days while inpatient. Patients discharged home or transferred to the intensive care unit (ICU) will be discontinued off drug permanently.
15796320|NCT04481685|Drug|Placebo|Placebo pill will be taken twice daily preferably spaced 12 hours apart.
15796321|NCT04481672|Drug|Magnesium Sulfate|Intravenous infusion of magnesium sulfate prior to intraoperative chemotherapy with cisplatin.
15796322|NCT04481659|Procedure|Lap partial ISR|A direct laparoscopic surgery with completely abdominal approach laparoscopic partial intersphincteric resection
15796323|NCT04481659|Combination Product|NCRT+Lap partial ISR|Preoperative radiation and chemotherapy + laparoscopic completely abdominal approach laparoscopic partial intersphincteric resection
15796324|NCT04481646|Diagnostic Test|Face mask sampling|Mask sampling consists of a modified face mask (flat surgical, duckbilled or FFP1) which contains up to strips of 3D printed Polyvinyl alcohol (PVA). As outlined in our previous work (ref lancet). These PVA strips are manufactured by the University of Leicester and measure approximately 50mm x 500mm and are fixed into place by adhesive pads. Mask assembly is conducted at the University of Leicester and are sterilised prior to use. Figure 3 and 4 shows examples of the inside of the mask with 4 strips placed inside and of how it is worn by study participants. The mask sampling system has been approved for previous studies in the UK, South Africa and The Gambia and has current approval for service improvement work at University Hospitals of Leicester NHS Trust for respiratory pathogens. It is awaiting approval as a medical device with the Medicines and Healthcare products Regulatory Agency.
15796325|NCT04481633|Diagnostic Test|COVID 19 serology|Diagnosis of Covid-19 past infection will be made by serology
15796326|NCT04481633|Other|COVID 19 Self-Questionnaire|COVID 19 Self-Questionnaire
15796327|NCT04481607|Drug|TQB3454|TQB3454 tablets is a small molecule oral drug.
15796328|NCT04481594|Drug|HPN-01|25 mg, 50 mg, 100 mg, 150 mg, 200 mg and 300 mg HPN-01 capsules
15796329|NCT04481594|Drug|Placebo|25 mg, 50 mg, 100 mg, 150 mg, 200 mg and 300 mg HPN-01 placebo capsules
15796330|NCT04481581|Other|Electronic Alerts|When FiO2 remains =>0.4 and SpO2 =>94% for more than 45 minutes, an electronic health record based alert will be sent to respiratory therapists to titrate oxygen per decision support tool.
15796331|NCT04481568|Behavioral|PES-4-BPSD Model|We will conduct a non-randomized preliminary efficacy trial, enrolling N=158 patients (79 control and 79 intervention). The primary outcome will be presence of BPSD as measured by a patient's total score on the Neuropsychiatric Inventory-Questionnaire (NPI-Q) during hospitalization. A multi-modal approach (including chart review and HCG questionnaires) will be used to determine the presence and severity of BPSD.
15796332|NCT04481568|Behavioral|The attention control condition|On this unit, the management of patients who display BPSD is performed by nurse assistants, rather than PES. Therefore, in order to test the added layer of PES staff, the nurse assistants on the control unit will receive equivalent dementia care education and training as well as staff support (please refer to NCT# 04179721 for more details on this aim).
15796333|NCT04481555|Drug|Azithromycin|Prophylactic azithromycin treatment 250 mg three times weekly vs placebo
15796334|NCT04481555|Drug|ICS|All patients will receive LABA/LAMA medication. The ICS medication will be switched on/off according to the most recent blood eosinophil count (at inclusion + every 3 months) vs continued LABA/LAMA/ICS treatment
15796335|NCT04481542|Diagnostic Test|MRI|check MRI quality in aorta
15796336|NCT04481529|Other|Health Questionnaire|Completion of a short questionnaire noting the result of the serology and looking for elements in favor of exposure to the virus, whether professional or extra-professional.
15796337|NCT04481516|Other|Yoga|SKY Yoga
15796338|NCT04481477|Other|Nursing care to reduce anxiety, fear and loneliness|Decreased anxiety Presence Emotional support Improved security Increasing coping capacity Presence Emotional support Facilitating visits
15796339|NCT04481451|Procedure|Erector spinae block with ropivacaine 0.2%|Single-shot ultrasound-guided nerve block performed ipsilateral to surgical site.
15796340|NCT04481451|Procedure|Quadratus lumborum block with ropivacaine 0.2%|Single-shot ultrasound-guided nerve block performed ipsilateral to surgical site.
15796341|NCT04481451|Drug|Ropivacaine|ropivacaine 0.2% nerve block injection
15796342|NCT04481438|Other|Acupunch Exercises|The acupunch exercise program was developed based on Jing-Luo theory of tranditional Chinese Medicine. The experiment group will receive Acupunch exercise for 40 minute sessions, 3 times a week, for 24 weeks
15796343|NCT04481425|Other|SMS intervention|SMS intervention
15796344|NCT04481412|Drug|Topical cetirizine|Topical cetirizine 1% spray that will be prepared at Faculty of Pharmacy, Cairo University and will be applied once daily.
15796345|NCT04481412|Drug|Placebo|96% ethanol that will be applied once daily.
15796346|NCT04481412|Drug|Topical minoxidil|Topical Minoxidil 5% that will be applied once daily.
15796347|NCT04481399|Behavioral|Family Strengthening Intervention for Early Childhood Development|The Family Strengthening Intervention for Early Childhood Development (FSI-ECD) is an evidence-based home-visiting behavioral intervention for vulnerable families with children aged 6-36 months. The FSI-ECD targets improving parental emotion regulation and parent-child interactions to improve parental mental health and child development outcomes and reduce family violence. FSI-ECD compromises five core components delivered in 12 modules delivered in weekly sessions via active coaching by community health workers. Core components include coaching on: a) nutrition, health and hygiene; b) early stimulation and playful parenting; c) building resilience and coping skills; d) building problem-solving skills; and d) building emotion regulation and conflict resolution skills.
15796348|NCT04481399|Other|Community Health Worker Routine|Standard CHW care involves three home visiting sessions delivered to families following childbirth with weekly supervision via phone or face-to-face. Topics of home visiting sessions include: skilled post-natal care for mothers, early initiation of breastfeeding and exclusive breastfeeding practices, adequate nutrition, immunization services and timely use of these services, hand washing and hygiene practices (including waste disposal and food hygiene), building the capacity of family members to appropriately take care of newborns and children under age 5, and building the capacity of family members to recognize and act on postnatal danger signs for newborns, mothers, and children under 5. CHWs also conduct screenings for acute malnutrition and growth monitoring to identify early referrals, and they can provide family planning methods, deworming tablets and other vitamins for acute malnutrition, dehydration, and anti-malaria treatment. Each home-visiting session lasts about 60 minutes.
15796349|NCT04481386|Device|Vitargus, BFC-1401|A single intravitreal (IVT) dose of BFC-1401 in participants as a vitreous substitute during vitrectomy surgery.
15796350|NCT04481373|Behavioral|THRIVE|"The ACT components (3-3.5 hours) will focus on clarifying patient values and goals and identifying obstacles that may be getting in the way of living a rich life. Short-and long-term effects of avoidance will be discussed (e.g., avoidance reduces immediate contact with distressing experiences and provides short-term relief but leads to greater dysfunction in long run). Patients will be taught acceptance, mindfulness, and perspective taking to help patient cope with difficult emotions and thoughts that may interfere with living a values-driven life. Individuals will also be encouraged to examine the costs of stigmatization on their life (e.g. avoidance of medical care, sense of isolation).
~Education will include medical information about HIV, services available at the clinic, and health needs related to comorbidities. This content to be delivered in 30 minutes."
15796351|NCT04481373|Other|Treatment as Usual|Patients get usual care at the hospital. Service linkage workers (SLWs) meet with all hospitalized PWH and cover educational aspects of the care.
15796352|NCT04481360|Device|CT of the chest|Degree of affection on the lung infected by COVID19
15796353|NCT04481347|Device|Sleep EEG recording using a DREEM® headband|Sleep EEG recording using a Dreem® headband (Rythm, Paris, France), an EEG recording device adapted to sleep conditions and completely non-invasive
15796354|NCT04481347|Other|Montreal Cognitive Assessment (MoCA)|Neuropsychological assessment using the The Montreal Cognitive Assessment (MoCA) questionnaire to detect postoperative cognitive dysfunction
15796355|NCT04481347|Device|Intraoperative EEG recording using a Sedline® monitoring|Intraoperative brain function monitoring using a Sedline® module (Masimo corporation) to evaluate the state of the brain under anesthesia
15796356|NCT04481334|Other|Collaborative occupational therapy interactive vaulting group|Children will participate in a weekly 60 minute group that focuses on the devilment of social skills by incorporating activities that require team work. Part of the intervention will incorporate the equine to better understand non-verbal body language. It should be noted that each child will have two agreed upon goals developed that are agreed upon by the child and the parent and will be of emphasis during each group.
15796357|NCT04481321|Biological|Biological/Vaccine|
15796358|NCT04481308|Drug|propofol (2 mg/kg) and fentanyl (1ug/kg) and 4 liters O2 flow through nasal cannula|propofol (2 mg/kg) and fentanyl (1ug/kg) and 4 liters O2 flow through nasal cannula
15796359|NCT04481295|Other|High-flow nasal cannula|The nasal high flow therapy has enabled high flow oxygen to be derived through nasal cannula. This mode not only allows constant FiO2 during peak inspiratory flow but also confers benefits including a low level of continuous positive airway pressure with increased end-expiratory lung volume and reduced work of breathing, partly through intrinsic positive end-expiration pressure compensation and dead space washout. The inspired gases are warmed and humidified, improving comfort and possibly reducing airway inflammation, leading to improved drainage of respiratory secretions.
15796360|NCT04481295|Other|Low SpO2|Low SpO2
15796361|NCT04481282|Drug|Terbutaline|2.5mg po tid for 12 weeks
15796362|NCT04481282|Drug|Danazol|200mg po bid for 12 weeks
15796363|NCT04481269|Device|Surface-modified composite coated orthopedic implants|The surface-modified composite coated orthopedic implants have the capacity of high binding strength, high tissue-inducing activity and intelligent bacteria-resistance. The implant devices are expected to be used in the prevention and treatment of plant-related infections in orthopedic surgeries.
15796364|NCT04481269|Device|conventional orthopedic implants|conventional orthopedic implants
15796365|NCT04481256|Radiation|External beam radiotherapy|External beam radiotherapy will be delivered to a total dose of 50.4 Gy in 28 fractions of 1.8 Gy, 5 fractions per week, starting the first day of the first cycle of chemotherapy
15796366|NCT04481256|Drug|Bintrafusp alfa|Bintrafusp alfa will be given i.v. every three weeks on day 1, 22, and 43 at a dose of 2400 mg.
15796367|NCT04481256|Drug|Paclitaxel|Paclitaxel 50 mg/m2 will be given intravenously (i.v.) on days 1, 8, 15, 22, 29 and 36.
15796368|NCT04481256|Drug|Carboplatin|Carboplatin AUC = 2 will be given intravenously (i.v.) on days 1, 8, 15, 22, 29 and 36.
15796369|NCT04481243|Biological|Pneumovax 23- pneumococcal polysaccharide|Children will receive Pneumovax 23 vaccination. Vaccine response as assessed by Global IgG will be drawn 4-6 months after immunization.
15796370|NCT04481230|Drug|99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg|1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 5 MBq/kg (D0)
15796371|NCT04481230|Drug|99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kg|1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 10 MBq/kg (D0)
15796372|NCT04481230|Drug|99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg|1 intravenous injection of 99mTc-NTP 15-5 at a diagnostic activity of 15 MBq/kg (D0)
15796373|NCT04481217|Other|Self-questionnaires battery|"Childhood trauma questionnaire (Bernstein, Ahluvalia, Pogge, & Handelsman, 1997; Bernstein et al., 2003)
~The Young schema questionnaire short form (SQ-SF ; Cottraux & Black, 2006; Young, 1998).
~Dissociative experiences scale (Laroi et al., 2013).
~Launay-Slade hallucination scale (Bentall & Slade, 1985; Launay & Slade, 1981)
~Cardiff Anomalous Perceptions Scale (Bell et al., 2006)"
15796374|NCT04481217|Other|Socio-demographic screening|age; gender; education; highest diploma; job; marital status; living place
15796375|NCT04481204|Drug|Cisplatin|Given IV
15796376|NCT04481204|Drug|Fluorouracil|Given IV
15796377|NCT04481204|Drug|Gemcitabine|Given IV
15796378|NCT04481204|Drug|Irinotecan|Given IV
15796379|NCT04481204|Drug|Leucovorin|Given IV
15796380|NCT04481204|Drug|Nab-paclitaxel|Given IV
15796381|NCT04481204|Drug|Oxaliplatin|Given IV
15796382|NCT04481204|Radiation|Radiation Therapy|Undergo RT
15796383|NCT04481191|Biological|RotaTeq (V260)|Live, pentavalent rotavirus vaccine administered as a 2 mL-dose oral solution
15796384|NCT04481191|Biological|IPV|0.5 mL dose IPV (Sabin strain based), administered via IM injection
15796385|NCT04481178|Other|Laser (QS, Picosecond laser)|QS-Nd Yag Laser, Picosecond laser
15796386|NCT04481165|Other|Survey|Oral interview and written questions
15796387|NCT04481139|Drug|SHR0302|SHR0302, oral, once daily
15796388|NCT04481139|Drug|SHR0302 placebo|SHR0302 placebo, oral, once daily
15796389|NCT04481113|Drug|Abemaciclib|Given PO
15796390|NCT04481113|Drug|Niraparib Tosylate Monohydrate|Given PO
15796391|NCT04481100|Drug|itraconazole|Oral administration of itraconazole twice daily concurrent with chemoradiation
15796392|NCT04481087|Device|Clearfil Universal Bond Quick|Adhesive systems
15796393|NCT04481087|Device|Clearfil Universal Bond Quick|Adhesive systems
15796394|NCT04481087|Device|Clearfil Universal Bond Quick|Adhesive systems
15796395|NCT04481087|Device|Clearfil SE Bond|Adhesive systems
15796396|NCT04481087|Device|Tetric N-Bond|Adhesive systems
15796397|NCT04481074|Other|Inspiratory muscle training|Inspiratory muscle training will be performed using the tapered flow-resistive loading trainer (POWERbreathe®).
15796398|NCT04481061|Genetic|Electronic Decision Tool|Adolescents and a parent, if applicable, will use an electronic decision tool to make categorical choices of types of diseases (treatable, preventable, adult-onset, and carrier status) they want to learn about the adolescent. Granular choices can be made within each category.
15796399|NCT04481048|Drug|N-Acetyl cysteine|Eight (8) weeks of treatment with an FDA approved medication, N-acetylcysteine (NAC).
15796400|NCT04481048|Other|Placebo|Eight (8) weeks of treatment with placebo.
15796401|NCT04481035|Drug|N-acetylcysteine (NAC)|The study design is essentially a cross-sectional survey and then longitudinal evaluation of cognition and behavior, motor function, cortical function, and metabolomics profiles in NF1 before and after 8 weeks of treatment with an FDA approved medication, N-acetylcysteine (NAC) or placebo. This is a cross-over double-blind placebo controlled study. Participants in the experimental phase/arm will receive 70 mg/kg/dose (max dose 900 mg) three times per day of NAC for eight (8) weeks.
15796402|NCT04481035|Other|Placebo|The study design is essentially a cross-sectional survey and then longitudinal evaluation of cognition and behavior, motor function, cortical function, and metabolomics profiles in NF1 before and after 8 weeks of treatment with an FDA approved medication, N-acetylcysteine (NAC) or placebo. This is a cross-over double-blind placebo controlled study. Participants in the placebo phase/arm will receive placebo (non-drug) three times per day for eight (8) weeks.
15796403|NCT04481022|Other|proximal control exercises|"study investigates the effectiveness of proximal control exercises for patients with PFPS in improving pain and function. The findings of this systematic review are consistent with previous evidence reporting effectiveness of exercise for PFPS. In particular, there is consistent moderate to high quality evidence (three RCT, one CCT, three cohort studies, and one case series) that proximal interventions provide relief of pain and improved function in the short term, whereas the knee programs have variable effectiveness. Physical therapists should consider using proximal interventions for early stage treatment for PFPS (Peters et al., 2013).
~After 4 weeks of a combined knee and hip strengthening exercise program, sedentary females with PFPS had a greater reduction in pain during stair descent compared to the group who performed knee strengthening exercises only. Both groups also showed significant improvement in function and pain during stair ascent (Fakuda et al., 2010)."
15796404|NCT04481009|Drug|YH003|YH003 will be administered intravenously over 60 minutes every 21-day cycle.
15796405|NCT04481009|Drug|Toripalimab|Toripalimab with fixed dose of 240 mg administered intravenously followed by YH003 administered intravenously every 21-day cycle.
15796406|NCT04481009|Drug|Nab-paclitaxel|Nab-paclitaxel will be administered each 21-day cycle.
15796407|NCT04481009|Drug|Gemcitabine|Gemcitabine will be administrated each 21-day cycle.
15796408|NCT04480996|Drug|Drugs Responsible for Cognitive Side Effects|identification of road traffic accidents associated with drugs responsible for psychomotor side effects
15796409|NCT04480983|Device|Multidetector Computerized Tomography (MDCT)|To evaluate the role of MDCT in diagnosis of non traumatic causes of acute abdomen in pediatric patients with clinical and surgical correlation.
15796410|NCT04480970|Device|Nasogastric tube placement|All patients enrolled in the study will have a nasogastric tube placed for gastric decompression.
15796411|NCT04480957|Biological|ARCT-021 Dose 1|ARCT-021 Dose 1 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP)
15796412|NCT04480957|Biological|ARCT-021 Dose 2|ARCT-021 Dose 2 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021
15796413|NCT04480957|Biological|ARCT-021 Dose 3|ARCT-021 Dose 3 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021
15796414|NCT04480957|Biological|ARCT-021 Dose 4|ARCT-021 Dose 4 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021
15796415|NCT04480957|Biological|ARCT-021 Dose Regimen 1|ARCT-021 dose regimen 1 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021
15796416|NCT04480957|Biological|ARCT-021 Dose Regimen 2|ARCT-021 dose regimen 2 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021
15796417|NCT04480957|Other|Placebo|Sterile 0.9% saline
15796418|NCT04480931|Behavioral|mHealth Intervention Group|Access to the mobile health application with exercise plans and education
15796419|NCT04480931|Behavioral|Educational Brochure|An evidence-based educational brochure with general information about the benefits of physical activity during pregnancy
15796420|NCT04480918|Device|Electroconvulsive Therapy (ECT)|ECT for the treatment of treatment-resistant depression in an active major depressive episode
15796421|NCT04480918|Device|Transcranial Magnetic Stimulation (TMS)|TMS for the treatment of treatment-resistant depression in an active major depressive episode
15796422|NCT04480918|Drug|Ketamine|Intravenous ketamine infusion for the treatment of treatment-resistant depression in an active major depressive episode
15796423|NCT04480918|Drug|Esketamine|Intranasal esketamine insufflation for the treatment of treatment-resistant depression in an active major depressive episode
15796424|NCT04480905|Device|Dynamic tape|The dynamic tape will stick from anterior inferior iliac spine to the middle of the tibia in supine and full knee extension position
15796425|NCT04480905|Device|Sham tape|The 3M™ Soft Cloth Tape will stick from anterior inferior iliac spine to the middle of the tibia in supine and full knee extension position
15796426|NCT04480879|Drug|AZD8154 nebuliser|Nebuliser suspension
15796427|NCT04480879|Drug|AZD8154 Monodose DPI presented in capsules|AZD8154 Monodose DPI formulation delivered dose
15796428|NCT04480879|Drug|AZD8154 Placebo Monodose DPI presented in capsules|The dose correspond to AZD8154 Monodose DPI formulation
15796429|NCT04480866|Device|Colli-Pee® (FV5000 and Small Volumes)|"Colli-Pee® device (Novosanis, Belgium) attached to collector tubes prefilled with a non-toxic nucleic acid preservative (including an internal process control). The collector tubes differ in size to collect a total sample volume of 4, 10, and 20 mL.
~Each participant will collect three urine samples using the Colli-Pee Small Volumes 4 and 10 mL, and the Colli-Pee FV5000 (20 mL) device, in a random order."
15796430|NCT04480853|Drug|Fingolimod|Fingolimod 0.5 mg QD, oral
15796431|NCT04480840|Drug|PLN-74809|PLN-74809
15796432|NCT04480840|Drug|Placebo|Placebo
15796433|NCT04480827|Drug|Aramchol 600mg single dose|aramchol acid tablet 600mg, single dose
15796434|NCT04480827|Drug|Aramchol 300mg, bid|aramchol acid tablet 300mg, bid for 12 days
15796435|NCT04480814|Diagnostic Test|PIK3CA kit|Prospective investigation of clinical samples for evaluation of IVD clinical performance
15796436|NCT04480801|Other|Thermal Evaluation and Foot Care|Participants in the experimental group will be given foot care and thermal evaluation in the clinic and will be taught to the patient and / or their relatives. Thermal evaluation and foot care video will be uploaded to the patient and / or relative's phone.
15796437|NCT04480801|Other|Foot Care|Participants in the control group will be given foot care in the clinic and will be taught to the patient and / or their relatives. Foot care video will be uploaded to the patient and / or relative's phone.
15796438|NCT04480788|Biological|T cell injection targeting CD7 chimeric antigen receptor|Drug name: T cell injection targeting CD7 autologous chimeric antigen receptor. Package specification: 10-50ml bag, 1-4 bags / person, which is determined according to the body weight of the subject and the effective content of cell preparation
15796439|NCT04480775|Drug|Triamcinolone|transversus abdominis plane block with bupivacain and triamicinolone
15796440|NCT04480775|Drug|Methylprednisolone|transversus abdominis plane block with bupivacaine and methylprednisolone
15796441|NCT04480775|Drug|bupivacaine|transversus abdominis plane block with bupivacaine alone
15796442|NCT04480762|Drug|SHR-1703|SHR-1703
15796443|NCT04480762|Drug|Placebo|Placebo of the SHR-1703
15796444|NCT04480749|Diagnostic Test|Access to Facility based Syphilis Testing|List of facilities where syphilis testing can be accessed
15796445|NCT04480749|Diagnostic Test|Syphilis Self-Test|Rapid Treponemal Test kit
15796453|NCT04480723|Other|Blood Sample|Blood samples will be taken and analyzed to evaluate the presence of PH.
15796454|NCT04480723|Diagnostic Test|Cardiac MRI|Cardiac MRI will be performed to evaluate the presence of PH.
15796455|NCT04480710|Drug|CRV431|1 x 75mg softgel capsule
15796456|NCT04480710|Drug|Placebo|1 x placebo softgel capsule
15796457|NCT04480697|Drug|HPG1860|6 subjects randomized to active compound and 2 subjects randomized to placebo
15796458|NCT04480684|Diagnostic Test|Three-dimensional Endoanal Ultrasound|"Three-dimensional endoanal ultrasound is the gold standard diagnostic tool in the assessment of obstetric anal sphincter injury. The anorectal transducer is inserted directly into the anal canal which allows assessment of the anal sphincter complex.
~Patients will be assessed at weekly intervals with until the wound infection has resolved and the wound has clinically healed."
15796488|NCT04480450|Drug|Rituximab|Rituximab is a highly purified, 1328-amino acid antibody with an approximate molecular mass of 145 kD. Rituximab is a mouse human chimeric monoclonal antibody against CD20. Administration leads to between 90 and 100% peripheral B cell depletion via complement dependent cytotoxicity.
15796459|NCT04480684|Diagnostic Test|Transperineal Ultrasound(multiplanar)|"If endoanal ultrasound is declined or not tolerated, the anal sphincter will also be assessed using three-/four-dimensional (3D/4D) transperineal ultrasound with the probe placed externally on the area of the fourchette.
~Patients will be assessed at weekly intervals with until the wound infection has resolved and the wound has clinically healed."
15796460|NCT04480684|Diagnostic Test|The MolecuLight i:X: Bacterial autofluorescence camera|"The bacterial load of the perineal wound will be measured every week using the MolecuLight i:X. This is a system, which uses fluorescent illumination to capture and document the presence of bacteria.
~Patients will be assessed at weekly intervals with until the wound infection has resolved and the wound has clinically healed.
~These findings will be supported by microbiological analysis of the wound fluid with swab culture and sensitivity."
15796461|NCT04480684|Device|Silhouette® 3D camera: Three-dimensional wound measuring camera|For wound that have superficially dehisced, the wound surface area, depth, volume and healing progress will be precisely measured using the Silhouette® 3D camera. This is a system that uses 3D laser technology to track wound healing progression.
15796462|NCT04480671|Procedure|Level III support procedure|A level III support procedure is aimed at repairing the distal support of the vagina with either a posterior colporrhaphy and/or a perineorrhaphy.
15796463|NCT04480671|Procedure|Minimally Invasive Sacrocolpopexy|All study participants are planning with their surgeon a minimally invasive sacrocolpopexy (robotic or laparoscopic) to repair pelvic organ prolapse.
15796464|NCT04480658|Drug|Bryophyllum pinnatum 50 %, tablets into capsules (verum: 2x2capsules/day)|"Bryophyllum is administered for 3 weeks. Bryophyllum is given in form of capsules, 350mg per capsule, 0-0-2-2/d: 2 capsules 30min. before supper,2 capsules before going to bed.
~Other Names:
~Bryophyllum pinnatum/Kalanchoe"
15796465|NCT04480645|Device|CivaDerm|radioactive bandage
15796466|NCT04480632|Biological|Convalescent plasma|ABO compatible convalescent plasma obtained from from recovered COVID-19 patients
15796467|NCT04480619|Diagnostic Test|AIP-301|PET Diagnostic Agent
15796468|NCT04480606|Behavioral|Home exercise program|47 volunteers over 65 years old who are at home during the social isolation process due to the coronavirus outbreak will be included in home exercise group. A video exercise protocol was created and each exercise session was planned as daily 30 minutes for 6 weeks. Individuals will ask to do their exercises. It was planned to start the protocol with warm-up exercises and finish with cooling exercises. The exercise protocol was additionally determined as a combination of aerobic, balance and strengthening exercises. The exercise program consists of 3 levels and individuals will be provided to start at a level appropriate to their level of physical activity.
15796469|NCT04480593|Drug|Brazilian Green Propolis Extract (EPP-AF)|Green propolis extract (EPP-AF) administered orally or via nasoenteral tube.
15796470|NCT04480593|Other|Standard care|Standard treatment includes, as needed, supplemental oxygen (non-invasive and invasive), antibiotics or antivirals, corticosteroids, vasopressor support, renal replacement therapy and extracorporeal membrane oxygenation (ECMO).
15796471|NCT04480580|Diagnostic Test|SARS-CoV-2 Ab|Patient test for specific antibodies for SARS-CoV-2
15796472|NCT04480567|Drug|BMN 307|AAV Gene Therapy Infusion
15796473|NCT04480554|Drug|Methadone|Participants will receive a 48-week integrated treatment program for opiate use disorder with daily directly observed oral methadone syrup (MET), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy.
15796474|NCT04480554|Drug|Buprenorphine/naloxone|Participants will receive a 48-week integrated treatment program for opiate use disorder with daily directly observed oral buprenorphine/naloxone tablets (Suboxone(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy.
15796475|NCT04480554|Drug|XR-Naltrexone|Participants will receive a 48-week integrated treatment program for opiate use disorder with monthly extended-release naltrexone (Vivitrol(R)), structured counseling sessions (BDRC-based) weekly for the first 3 months and monthly thereafter, and antiretroviral therapy.
15796476|NCT04480541|Behavioral|Roadmap 2.0 information system|Caregivers and patients download the Roadmap 2.0 app on their own mobile phones/tablet
15796477|NCT04480541|Other|Wearable activity sensor|Caregivers and patients will receive a Fitbit wearable activity sensor
15796478|NCT04480541|Other|Survey administration|Caregivers and patients will be asked to complete health-related quality of life surveys
15796479|NCT04480528|Other|Blood Flow Restriction Training (BFRT)|A pressurized cuff is applied to the proximal thigh in order to partially occlude blood flow as the patient exercises.
15796480|NCT04480528|Other|Sham Blood Flow Restriction Training (Sham BFRT)|A minimally pressurized cuff is applied to the proximal thigh in order to mimic the active blood flow restriction unit as the patient exercises.
15796481|NCT04480515|Other|in-hospital mortality rate|In-hospital mortality rate during pandemic of 2020 will be compared with the in-hospital mortality rate of the last year's same time period
15796482|NCT04480502|Biological|Envafolimab|PD-L1 single domain antibody for subcutaneous injection.
15796483|NCT04480502|Drug|Ipilimumab|CTLA-4 monoclonal antibody
15796484|NCT04480489|Other|VR|"Task 1: Students will be first taken to the anesthesia lounge. Here the students will receive VR instructions on how to navigate Route 1 (i.e. they will watch a 360-degree immersive video using Samsung VR headset).
~Task 2: After completing the Route 1 walkthrough, the same group will be given traditional instructions (2D video) on navigating Route 2, followed by an observed walkthrough of Route 2.
~Students in the arm Group A will perform Task 1 using VR and then Task 2 using Traditional video. Meanwhile students in the arm Group B will perform Task 1 using Traditional video and Task 2 using VR"
15796485|NCT04480489|Other|Traditional|"Task 1: Students will be first taken to the anesthesia lounge. Here the students will receive traditional instructions (2D video) on how to navigate Route 1.
~Task 2: After completing the Route 1 walkthrough, the same group will be given VR instructions on how to navigate Route 2, followed by an observed walkthrough of Route 2.
~Students in the arm Group A will perform Task 1 using VR and then Task 2 using Traditional video. Meanwhile students in the arm Group B will perform Task 1 using Traditional video and Task 2 using VR"
15796486|NCT04480463|Drug|SCD411|IVT (intravitreal) injection
15796487|NCT04480463|Drug|Aflibercept|IVT injection
15796489|NCT04480437|Device|mp-BUS data collection|Collect ultrasound raw data and B-mode images of all kind of breast lesions to external storage device.
15796490|NCT04480424|Biological|GAMUNEX-C|Intravenous Immune Globulin (Human), 10% Caprylate/Chromatography Purified
15796491|NCT04480424|Drug|Standard Medical Treatment|SMT
15796492|NCT04480411|Behavioral|Doctorgram Patient Kit|Participants will use the Doctorgram Patient Kit for remote monitoring and remote use stethoscope.
15796493|NCT04480398|Drug|Guduchi Ghan Vati|Guduchi Ghan Vati is an Ayuvedic classical preparation which is prepared from aqueous of extract of Tinospora cordifolia.
15796494|NCT04480385|Other|Remote Automated Monitoring System|The patient will be monitored with conventional monitoring devices as well as the MultiSense patch
15796495|NCT04480372|Drug|Gemcitabine|Gemcitabine is administered at the dose of 1000 mg/m2 intravenously (i.v.) on day 1 and day 8 of each cycle (every 3 weeks).
15796496|NCT04480372|Drug|Atezolizumab|Atezolizumab is administered at the dose of 1200 mg i.v. on day 1 of each cycle (every 3 weeks).
15796497|NCT04480359|Drug|Bawei Shenqi Pill|5.1g, once a day, 3month, oral
15796498|NCT04480359|Drug|Bawei Shenqi Pill placebo|5.1g, once a day, 3month, oral
15796499|NCT04480359|Drug|Meloxicam|7.5mg, once a day, 3 month, oral
15796500|NCT04480346|Behavioral|Challenging Horizons Program|Intervention delivered in high schools provided by school mental health professional over the course of an academic year with twice-weekly meetings with students and 10 evening group meetings with students and 10 group sessions with parents.
15796501|NCT04480333|Drug|Drug: NA-831 - 0.10 mg/kg|NA-831 in nanoparticle inhalation formulation
15796502|NCT04480333|Drug|Placebo- 0.10 mg/kg|Placebo in nanoparticle inhalation formulation
15796503|NCT04480333|Drug|Drug: NA-831 - 0.20 mg/kg|NA-831 in nanoparticle inhalation formulation
15796504|NCT04480333|Drug|Placebo- 0.20 mg/kg|Placebo in nanoparticle inhalation formulation
15796505|NCT04480333|Drug|Drug: GS-5734 - 1.00 mg/kg|GS-5734 in nanoparticle inhaled formulation
15796506|NCT04480333|Drug|Placebo- 1.00 mg/kg|Placebo in nanoparticle inhalation formulation
15796507|NCT04480333|Drug|Drug: GS-5734 - 2.00 mg/kg|GS-5734 in nanoparticle inhaled formulation
15796508|NCT04480333|Drug|Placebo- 2.00 mg/kg|Placebo in nanoparticle inhaled formulation
15796509|NCT04480333|Combination Product|Drugs: NA-831 (0.10 mg/kg) plus GS-5734 (1.00 mg/kg)|The combined NA-831 and GS-5734 are in nanoparticle inhaled formulation
15796510|NCT04480333|Combination Product|Placebo 0.10 mg + 1.00 mg/kg|The combined placebo are in nanoparticle inhaled formulation
15796511|NCT04480333|Combination Product|Drugs: NA-831 (0.20 mg/kg) plus GS-5734 (2.00 mg/kg)|The combined NA-831 and GS-5734 are in nanoparticle inhaled formulation
15796512|NCT04480333|Combination Product|Placebo 0.20 mg + 2.00 mg/kg|Placebo 0.10 mg + 1.00 mg/kg
15796513|NCT04480320|Procedure|pericapsular nerve group block|Branches of both the FN and ON provide innervation to the anterior hip capsule. High and low branches of FN provided the majority of innervation to the lateral and superomedial hip capsule. The AON innervates the medial capsule.Both of the nerve close to the periosteum between the iliopubic eminence and AIIS ,by using ultrasound guided technique,these sites can be potential bony landmarks provid approch to the nerve group.
15796514|NCT04480307|Drug|temelimab 18 mg/kg|temelimab 18 mg/kg will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total).
15796515|NCT04480307|Drug|temelimab 36 mg/kg|temelimab 36 mg/kg will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total).
15796516|NCT04480307|Drug|temelimab 54 mg/kg|temelimab 54 mg/kg will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total).
15796517|NCT04480307|Drug|Placebo|Placebo will be given as monthly (4-weekly) intravenous (IV) infusions over 48 weeks (12 administrations in total).
15796519|NCT04480281|Drug|Lidocaine Iv|Patients in the Lidocaine group received a bolus of lidocaine 1% 1.5mg/kg at the induction of general anesthesia followed by a continuous infusion of lidocaine 1% 2mg/kg/h just before surgical incision and continued until 24h after the surgery
15796520|NCT04480281|Drug|Normal Saline|Patients in Group Placebo received an equal bolus volume of normal saline solution at induction, and then a continuous infusion started before surgical incision and maintained up until 24h postoperatively
15796521|NCT04480268|Drug|PAXG regimen (cisplatin, nab-paclitaxel, capecitabine, gemcitabine) chemotherapy|"The PAXG regimen includes:
~nab-paclitaxel 150 mg/m2 on day 1 and 15 of each cycle;
~cisplatin 30 mg/m2 on day 1 and 15 of each cycle;
~capecitabine 1250 mg/m2 on 1 day to 28 of each cycle;
~gemcitabine 800 mg/m2 on day 1 and 15 of each cycle. Each cycle lasts 28 days. Patients are treated until maximal response, disease progression or unacceptable toxicity."
15796522|NCT04480255|Other|Group 1: Standard of Care|"Those who are in Group 1 will receive the usual care which includes:
~a welcome packet from the nursing staff
~access to their infant's medical team including doctors and nurse
~opportunities to ask any questions and understand the care their baby is receiving through participation in daily work rounds or through setting up family meetings with the medical team."
15796523|NCT04480255|Other|Group 2: NICU2HOME+ app|In addition to the usual care made available to Group 1 as described above, Group 2 parents will receive the smartphone app. Group 2 parents will be asked to download the NICU2HOME app.
15796524|NCT04480242|Drug|Inhaled Corticosteroids (ICs)|Any corticosteroid (beclomethasone, budesonide, ciclesonide, fluticasone propionate, fluticasone furoate, mometasone, and triamcinolone) prescribed by the pediatrician as an inhaled controller medication, for daily management of asthma. The daily dose of ICs prescribed will be translated into beclomethasone equivalent.
15796525|NCT04480242|Drug|Fixed-Dose Combination of Inhaled Corticosteroids and Long- Acting Beta-agonist (ICs/LABA)|Beclomethasone/formoterol, budesonide/formoterol, fluticasone furoate/vilanterol, fluticasone propionate/formoterol, fluticasone propionate/salmeterol, and mometasone/formoterol. Any of these combinations prescribed by the pediatrician as an inhaled controller medication, for daily management of asthma.
15796526|NCT04480242|Drug|Other treatments|Low-dose oral corticosteroids, long-acting muscarinic antagonist (tiotropium), low-dose macrolides (azithromycin), leukotrienes receptor antagonists (i.e. montelukast), or biologic agents (i.e. omalizumab).
15796527|NCT04480242|Drug|Inhaler device|Pressurized metered-dose inhalers (pMDIs), Breath-actuated pMDIs, Dry powder inhalers (DPIs), Nebulizers, Soft Mist Inhalers.
15796817|NCT04477707|Drug|Finerenone (BAY94-8862)|10 mg or 20 mg Finerenone tablet to be given orally, once daily, administered in the FIDELIO or FIGARO clinical trial.
15796528|NCT04480242|Behavioral|Regularly monitoring of the Inhalation technique through mobile app|App users are randomized within each pediatrician into two groups of equal size defined within the subsample recruited, so that 50% of the participants are allocated to answer the inhalation techniques, and the other 50% are allocated to answer the environment support scales. Once the app is downloaded, at month 2 and every 6 months thereafter the intervention group answers the inhalation techniques scale (group 1) and the control group answers the environment support scale (group 2).
15796529|NCT04480229|Behavioral|Telenursing and Counseling|After the first face-to-face training, counseling on the phone was conducted every week for four cycles of chemotherapy treatment. In total, six counseling sessions and four face-to-face training sessions were conducted for each patient.
15796530|NCT04480216|Device|MAGUS|"An upper endoscopy will be performed with the use of fluoroscopy. The MAGUS will be placed under fluoroscopy. The good positioning and the absence of any complications will be confirmed by gastroscopy.
~An injection of contrast agent will be done to be sure of the correct positioning and that no complications was happened.
~The patient will be kept overnight, with liquid food for 2 and mashed food up to 7 days post procedure"
15796531|NCT04480203|Other|Stressproffen cognitive based stress management|The participants will download an app (Stressproffen 2A) with cognitive based stress management.
15796532|NCT04480203|Other|Stressproffen mindfulness based intervention|The participants will download an app (Stressproffen 2B) with mindfulness based intervention.
15796533|NCT04480203|Other|Control|The participants will receive no app. (They will be able to download it after the end of the 3 year study).
15796534|NCT04480190|Drug|Gemcitabine|IV Gemcitabine 1000mg/m2 to be given on Days 1, Day 8 (Before Cisplatin); 3 week cycles
15796535|NCT04480190|Drug|Cisplatin|IV Cisplatin 25mg/m2 to be given on Days 1, Day 8
15796536|NCT04480190|Drug|Fluorouracil|Infusional 5-FU 225 mg/m2/d via Continuous IV infusion, to be given Days 1-5 and 8-12 during RT
15796537|NCT04480190|Radiation|Short course ChemoRT|"Radiation Therapy:
~Sim: All patients will undergo 4D-CT simulation with 3 hours fasting with or without IV contrast. Compression may be used depending on the tumor motion.
~Radiation Target Volume: The gross tumor volume (GTV) will be defined on all relevant imaging datasets including diagnostic CT, MRI, MRCP and/or ERCP data. An iGTV will be generated using the 4D datasets. The clinical target volume (CTV) will include the entire iGTV as well as portal lymphatic and celiac nodal space for all patients with selective treatment of the SMA and pancreaticoduodenal depending on the tumor location. A 5 mm margin will be added to the CTV to generate the planning target volume (PTV).
~Radiation Dose: The dose will be 30 Gy in 10 fractions (3 Gy per fraction) for all patients using either 3D Conformal or Intensity Modulated Radiation Therapy techniques."
15796538|NCT04480177|Device|foot insole|the subject was instructed to wear foot insole for 8 hours.
15796539|NCT04480177|Other|short foot exercise|the subject was instructed to perform exercise once a day 30 repetitions.
15796540|NCT04480164|Drug|NDMC|Repeated oral administration of ascending daily doses of NDMC (40mg, 60mg,120mg/day) vs placebo in 3 sequential cohorts
15796541|NCT04480151|Other|standard of care|retrospective study: standard of care
15796542|NCT04480138|Drug|Pegylated Interferon-α2b|1 mcg/kg on day 1 and day 8 after safety evaluations.
15796543|NCT04480138|Other|Standard of Care|Standard of care as per local authority
15796544|NCT04480125|Drug|Azacitidine|100mg D1-7
15796545|NCT04480125|Drug|Chidamide|30mg BIW PO
15796546|NCT04480112|Behavioral|Technology based social interactions|Participants will be socially interacting using any available technology with members of the research team.
15796547|NCT04480112|Other|No research related technology based social interactions|No technology based social interactions with the research team.
15796548|NCT04480099|Drug|CHOP for 6 cycles|Cyclophosphamide 750mg/m2, ivgtt D1, doxorubicin 50mg/m2,ivgtt D1 Vincristine 1.4mg/m2（max 2mg）, ivgtt D1 Prednisone 60mg/m2 （max 100mg）,PO,D1-D5 every 21 days for total 6 courses
15796549|NCT04480099|Drug|CHOP+X for 6 cycles|"X: X(i.e. targeted drug) will decided by NGS results as following. Decitabine 10mg/m2 ivgtt D-5 to-1 if with TP53 gene muation. Azacitadine 100mg/day ivgtt D-7 to -1 if with TET2/KMT2D gene mutation. Chidamide 20mg/day po D1,4,8,11 if with CREBBP/EP300 gene mutation. Lenalidomide 25mg/day po D1-10 if without gene mutation above.
~CHOP:Cyclophosphamide 750mg/m2, ivgtt D1, doxorubicin 50mg/m2,ivgtt D1 Vincristine 1.4mg/m2（max 2mg）, ivgtt D1 Prednisone 60mg/m2 （max 100mg）,PO,D1-D5 every 21 days for total 6 courses"
15796550|NCT04480086|Drug|Mivebresib|Tablet: Oral
15796551|NCT04480086|Drug|Navitoclax|Tablet; Oral
15796552|NCT04480086|Drug|Ruxolitinib|Tablet; Oral
15796553|NCT04480073|Procedure|Customized CAD-CAM Titanium Mesh (Y-xoss CBR® by Reoss -Filderstadt - Germany) for Guided Bone Regeneration of atrophic alveolar ridges|"Step one:1) exposure of atrophic areas; 2) bone harvesting from mandible or calvarium; 3) filling the meshes with a mixture of the autogenous bone and particulated xenograft in a 1:1 ratio; 4) stabilization of the mesh with titanium micro-screws.
~A post-operative cone-beam computed tomography (CBCT) will be done in all patients to have a reference point for the following controls.
~6 months later, patients are re-evaluated with a new CBCT to check bone volumes of the regenerated tissues and to plan implant placement.
~Step two: 1) removal of the meshes; 2) preparation of implant sites (one of which will be randomly chosen to obtain a bone biopsy for histomorphometric analysis); 3) implant placement.
~3 months later, implants will be uncovered and the prosthetic phases will start.
~Patients will be recalled 3, 6, and 12 months later, to assess peri-implant hard and soft tissue conditions, the stability of the reconstructed bone, and the onset of implant-related complications."
15796554|NCT04480060|Diagnostic Test|COVID-19 diagnostic PCR|Nasopharyngeal swab samples will be analyzed by PCR for COVID-19 DNA existence.
15796555|NCT04480047|Device|Tetranite Stabilization Material (TN-SM)|Dental adhesive for increased implant stabilization
15796586|NCT04479761|Behavioral|Visual and Auditory Cues|Within each scene there will be 2 levels of visual input (static or dynamic) combined with 3 levels of sounds (static, none or dynamic). Postural responses to each combination will be evaluated in order to assess the role of generated and natural sounds in postural control and whether static sounds can improve balance within dynamic virtual environments.
15796587|NCT04479748|Drug|Dexamethasone|Treatment of pain and inflammation following ophthalmic surgery
15796588|NCT04479748|Drug|Prednisolone Acetate 1% Oph Susp|Topical steroid
15796848|NCT04477460|Dietary Supplement|Non-thickened feeds|Non-thickened feeds directed by medical team
15796556|NCT04480034|Procedure|Bariatric procedures|All standard, laparoscopic bariatric procedures endorsed by SICOB (Società Italiana della Chirurgia dell'Obesità, Italian Society of Obesity Surgery) and by IFSO (International Federation of the Societies of Obesity Surgery), will be considered: sleeve gastrectomy, R-en-Y gastric bypass, one anastomosis gastric bypass, single anastomosis duodeno-ileal bypass with sleeve. The selection criteria for the surgery candidates will comply to the latest guidelines for bariatric surgery endorsed by SICOB, IFSO and EAES (European Association of Endoscopic Surgery). All the participating centers will follow the usual recruitment protocol. Restart of the bariatric elective surgery is based on the guidelines of SICOB for the bariatric surgery restart in Italy during the COVID-19 phase 2-3 of endemics.
15796557|NCT04480021|Behavioral|MITHRA|A mobile based application (app) in CBOs to screen, track and treat mild to moderate depression among low income women using Healthy Activity Program (HAP),a WHO-recommended evidence-based intervention.
15796558|NCT04480021|Behavioral|EUC|Group education on depression by community health workers
15796559|NCT04480008|Behavioral|Resilient Living Program|Participants will be given the journal Resilient Living with Dr. Sood: Building Strength for Difficult Days to use throughout the study. The initial session with one of the investigators will be an introduction and a review of Module 1: Gratitude, and will last 30-60min. Three follow-up sessions will occur approximately every two weeks and the participants should view the videos before those virtual meetings (Session 2 will review Module II: Mindful Presence; Session 3 will review Module III: Kindness; Session 4 will review Module IV: Resilient Mindset). The videos will take approximately 30 minutes each to review and virtual sessions will each take 30-60 minutes.
15796560|NCT04479995|Behavioral|Horizon Program|Telehealth videoconferencing sessions and questionnaires.
15796561|NCT04479995|Behavioral|Usual Care|Standard medical visits with additional paper or electronic booklet.
15796562|NCT04479969|Behavioral|Video Chat|Video chat with health coach using a computer tablet.
15796563|NCT04479956|Procedure|Varicose vein surgery|sapheno-femoral junction (SFJ) incompetence, GSV reflux from the groin to below the knee
15796564|NCT04479943|Other|MOVIN|MOVIN is a multi-component unit-based intervention comprised of five components that are implemented simultaneously in a hospital unit. The five components are: 1) psychomotor skills training, 2) unit ambulation culture, 3) communication, 4) resources, 5) ambulation environment.
15796565|NCT04479930|Other|Pulmonary Care Web-Based App (HappyAir App)|The HappyAir app reminded the HappyAir group daily to use the app, indicating that they record medication intake, daily exercise time (minutes), level of tiredness after the exercises (good, little tired, very tired, or exhausted), and daily mood (happy, little sad, sad, or very sad). The HappyAir integrated plan was designed as a model of a therapeutic program based on communication that introduced the figure of the therapeutic educator (physiotherapist or respiratory coach) in order to design interventions focused on the patients and their needs, with minimal intervention and presence, making the patients responsible for their self-care and management of their illness. Patient and educator shared responsibility.
15796566|NCT04479917|Drug|TPN171H|Pharmaceutical form;tablets Route of administration:;oral;Administered 30 minutes to 4 hours prior to initiation of sexual activity for a duration of 8 weeks to use no more than one dose in any 24-hour period
15796567|NCT04479917|Drug|placebo|Pharmaceutical form;tablets Route of administration:;oral;Administered 30 minutes to 4 hours prior to initiation of sexual activity for a duration of 8 weeks to use no more than one dose in any 24-hour period
15796568|NCT04479904|Drug|Famitinib|po
15796569|NCT04479891|Drug|pyrotinib tablet|single oral dose of SHR6390 or co-administered with itraconazole
15796570|NCT04479891|Drug|Itraconazole capsule|200 mg itraconazole QD
15796571|NCT04479865|Drug|Aricept 5mg Tablet|1 tablet once daily
15796572|NCT04479865|Drug|Aricept 10mg Tablet|1 tablet once daily
15796573|NCT04479865|Drug|DA-5207 150mg|1 patch once weekly
15796574|NCT04479865|Drug|DA-5207 170mg|1 patch once weekly
15796575|NCT04479852|Drug|SP-624|Oral capsule
15796576|NCT04479852|Drug|Placebo|Oral capsule
15796577|NCT04479839|Diagnostic Test|Ultrasound of the airway|Placing ultrasound on the neck after intubation
15796578|NCT04479826|Device|Advanced hybrid closed loop system|Free living follow-up of meal handelling
15796579|NCT04479813|Drug|Moxonidine 0.2 MG|Subjects will be allocated to undergo conditioning or non conditioning assigned in a randomized order. Participants will be given placebo or 0.2mg of Moxonidine to take orally 20 minutes prior to the first endothelial function measurement.
15796580|NCT04479813|Other|placebo|Subjects will be allocated to undergo conditioning or non conditioning assigned in a randomized order. Participants will be given placebo or 0.2mg of Moxonidine to take orally 20 minutes prior to the first endothelial function measurement.
15796581|NCT04479800|Drug|ASTX660|Form: capsule; Route of administration: oral
15796582|NCT04479787|Device|Spinal Cord Stimulation|Utilization of BURSTDR stimulation
15796583|NCT04479787|Other|Comprehensive Medical Management|Assessing type of CMM, location and frequency.
15796584|NCT04479774|Other|Compelled Body Weight Shift Technique|"Routine Physical Therapy with 0.6 cm thickness insole inserted in shoe of unaffected side and following exercises were performed by patients
~Muscle re-education
~Sit to stand exercise , 4 to 10 repetitions
~Supported heel raise to 10 repetitions with 3 sets
~Supported squat exercise tibialis anterior and quads muscles to 10 repetitions with 3 sets
~Gait training
~Forward walk in parallel bars with number of 10 rounds.
~Task oriented training balance training
~A. Stepping exercise on 15 cm height step and number of repetitions 10.
~B. Tandem standing for 10 seconds.
~C. Reaching exercise in which patient performed reaching for object in therapists hand and the number of repetitions was 10."
15796585|NCT04479774|Other|Compelled Body Weight Shift Technique without insole|"Routine Physical Therapy without 0.6 cm thickness insole inserted in shoe of unaffected side and following exercises were performed by patients
~Muscle re-education
~Sit to stand exercise , 4 to 10 repetitions
~Supported heel raise to 10 repetitions with 3 sets
~Supported squat exercise tibialis anterior and quads muscles to 10 repetitions with 3 sets
~Gait training
~Forward walk in parallel bars with number of 10 rounds.
~Task oriented training balance training
~A. Stepping exercise on 15 cm height step and number of repetitions 10.
~B. Tandem standing for 10 seconds.
~C. Reaching exercise in which patient performed reaching for object in therapists hand and the number of repetitions was 10."
15796849|NCT04477421|Procedure|FS-SMILE|Femtosecond small incision lenticule extraction
15796589|NCT04479735|Device|Virtual Reality Goggles|Virtual reality goggles will placed at least 2 min prior to venipuncture to deteremine if it mitigates perceived anxiety or perceived pain scores.
15796590|NCT04479722|Device|Left atrial appendage closure procedure|Implant LAAC system in LAA through percutaneous intervention
15796591|NCT04479696|Other|Educational Intervention|Receive standard of care verbal and written education materials
15796592|NCT04479696|Other|Questionnaire Administration|Ancillary studies
15796593|NCT04479696|Other|Survey Administration|Complete optional survey
15796594|NCT04479696|Other|Video|Watch NIRS video
15796595|NCT04479683|Other|FTH then DH support|"FTH output and DH relay one day a week until the minimum healthy weight. This treatment combines over one day a medical evaluation by a senior psychiatrist, family work (parents group and multi-family therapy session), a therapeutic education group, a cognitive remediation group and a dietary follow-up with therapeutic meals.
~During this phase, all children are evaluated once a week on a somatic level."
15796596|NCT04479683|Other|standard care|continuation of full-time hospitalization until the minimum healthy weight is reached, defined as the weight corresponding to the return to the previous BMI corridor (previous BMI +/- 1 BMI corridor, e.g. change from 25th to 10th percentile). This management combines bi-weekly medical follow-up by a senior psychiatrist, weekly family work, weekly therapeutic education group, weekly cognitive remediation group and bi-weekly dietary follow-up with therapeutic meals.
15796597|NCT04479657|Drug|QingFei Granule|QingFei Granule is made from 6 commonly herbal medicine granule, such as Jingjie,Huang Qin,Lianqiao,etc. The children were given one package of QingFei Granule every day, dividing into 3 times to be administrated. It's be given for 5 days.
15796598|NCT04479657|Drug|Cefuroxime|30mg/kg/d,bid, used until to the normalization of blood routine。
15796599|NCT04479644|Drug|BRII-198|BRII-198 given intravenously
15796600|NCT04479644|Drug|Placebo|Placebo given intravenously
15796601|NCT04479631|Drug|BRII-196|BRII-196 given intravenously
15796602|NCT04479631|Drug|Placebo|Placebo given intravenously
15796603|NCT04479618|Device|Usual Practice|A saline soaked piece of gauze, conformed to the size of the open ulcer area, will be placed over the ulcer and held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.
15796604|NCT04479618|Device|Improvised dressing|A piece of a new food-grade plastic bag, cut slightly larger than the ulcer, will be placed over the ulcer, sealed at the edges with an emollient to create an occlusive dressing. The dressing will be gently conformed to the ulcer contours to eliminate dead space, and a slit will be cut in the center to allow excess fluid to escape into a clean absorbent material placed over the slit. The device will be held in place with a wrap of stretch gauze. Ulcers will be rinsed with saline at daily dressing changes, which will be conducted by the patient after they master the procedure.
15796605|NCT04479618|Device|Advanced dressing|A piece of polymeric membrane dressing, cut to extend at least 0.5cm beyond the open ulcer edges, will be placed over the ulcer and held in place with a wrap of stretch gauze. The approximate wound edges will be marked on the back of the dressing. Dressing changes will consist only of removing the dressing when the saturation level, visible through the wound backing, reaches the mark indicating the dressing edges and applying a new cut dressing. Changes will be conducted by the patient after they master the procedure.
15796606|NCT04479592|Other|Particle counter|Particle counter to measure the aerosol generated
15796607|NCT04479579|Drug|Apixaban 2.5 milligram|apixaban 2.5 milligram twice daily from discharge until postoperative day 29 +/- 1 day
15796608|NCT04479566|Drug|Lithium Carbonate 250 MG|Patients undergoing video assisted thoracic surgery during the morning will take 250mg lithium carbonate 6 hours after surgery.
15796609|NCT04479566|Drug|Calcium Carbonate 500 MG|Patients undergoing video assisted thoracic surgery during the morning will take calcium carbonate 500mg 6 hours after surgery.
15796610|NCT04479553|Drug|Qizhi Tongluo Capsules|Qizhi Tongluo Capsule, a Chinese patent medicine composed of 26 Chinese herbs, has been approved by China Food and Drug Administration for treating recovery period of ischemic stroke (drug approval numbers: B20171001).
15796611|NCT04479540|Radiation|Angiography scanner|systematic thoracic angiography scanner to diagnose pulmonary embolism and additional blood sample (hemostasis exploration)
15796612|NCT04479527|Drug|Camrelizumab|Camrelizumab for injection is used to treat patients with relapsed or refractory classic Hodgkin lymphoma who have undergone at least second-line chemotherapy. Approved by the Drug Administration (NMPA) on March 4, 2020, for the treatment of patients with advanced hepatocellular carcinoma who have previously received sorafenib therapy and/or oxaliplatin-containing chemotherapy.Apatinib Mesylas is a small-molecule VEGFR tyrosine kinase inhibitor. It mainly treats malignant tumors by inhibiting VEGFR to play an anti-angiogenic effect. It has been approved by the China Food and Drug Administration (CFDA) in November 2014. It is used as a monotherapy for advanced gastric adenocarcinoma or gastric-esophageal junction adenocarcinoma that has progressed or relapsed after receiving two kinds of systemic chemotherapy. Apatinib Mesylas can effectively inhibit VEGFR2 at very low concentrations, and higher concentrations can also inhibit PDGFR, c-Kit and c-Src and other kinases.
15796613|NCT04479514|Other|Warm Baths or Showers|Daily warm baths or showers
15796614|NCT04479514|Other|Moisturizer|moisturizers applied daily immediately after bathing
15796615|NCT04479514|Drug|SPF 30 or Higher Suncreen|Mineral based sunscreen of SPF 30 or higher applied on a daily basis on all sun exposed areas.
15796616|NCT04479514|Other|Sun Protective Clothing|Sun protective clothing worn when outdoors
15796617|NCT04479514|Behavioral|Limited Sun Exposure|Limit sun exposure during peak hours of 10am-4pm
15796618|NCT04479514|Other|Dilute bleach baths|Warm 10-15 minute dilute bleach baths every other day
15796619|NCT04479501|Other|Asthma exacerbation related hospitalization|Evaluate the difference between patients with single and multiple hospitalizations for asthma exacerbation
15796738|NCT04478318|Device|uEXPLORER/mCT|Participants will undergo a total-body PET/CT scan with the uEXPLORER scanner first, followed by a PET/CT scan with the conventional mCT PET/CT scanner.
15796739|NCT04478318|Device|mCT/uEXPLORER|Participants will undergo a PET/CT scan with the conventional mCT PET/CT scanner, followed by a total-body PET/CT scan with the uEXPLORER scanner
15796622|NCT04479475|Behavioral|Supportive care through community support persons|"Eligible MMT patients identify a drug-free family member or friend (CSP) to attend weekly group sessions together. The CSP learns methods to support and reinforce MMT retention and ART adherence. Through weekly homework assignments, the CSP helps the patient engage in social, drug-free activities and connect to existing community resources (e.g. mutual-help groups, religious groups, sports groups, etc.) in efforts to expand the patient's recovery and treatment network."
15796623|NCT04479462|Procedure|total joint arthroplasty|The surgery includes primary, revision or partial joint arthroplasty.
15796624|NCT04479449|Drug|SP-8203|SP-8203 80 mg will be intravenously administered as 40 mg/dose twice daily (intervals of 12 hours)
15796625|NCT04479449|Drug|Placebo|Placebo will be intravenously administered twice daily (intervals of 12 hours)
15796626|NCT04479436|Drug|U3-1402|U3-1402 will be dosed at 5.6 mg/kg as an intravenous (IV) infusion administered on Day 1 of each 21-day cycle.
15796627|NCT04479423|Procedure|Soda-water instead of pure water to observe gastric filling|All patients underwent a bowel preparation that consisted of a low-residue diet for 24 hours, fluid intake, and ingestion of 2L polyethylene glycol-based electrolyte solution 12 hours before the examination. On the examination day, patients arrived at hospital in the morning after an over night fast (>8hours). Then they would be randomly assigned to controll group or soda group. 40 minutes before capsule ingestion, all patients swallowed 100ml clear water containing 50mg simethicone. During the period, patients were asked to have a proper walk to wash out bubbles. An additional 900ml pure water or 400ml soda-water was drunk to obtain good vision before undergoing MCE examination.
15796628|NCT04479397|Procedure|Latarjet Surgery for anterior shoulder instability|Bone block procedure for anterior shoulder instability
15796629|NCT04479397|Procedure|No sling in postoperative care|No sling will be used in postoperative care.
15796630|NCT04479384|Other|Manual therapy - osteopathic techniques|"HVLAT if any somatic dysfunction in T1-T5
~Stretch intrathoracic fascia x 3
~Recoil sternum x 3
~Cranial base release, 4 phases"
15796631|NCT04479371|Drug|Liposomal bupivacaine|Injecting liposomal bupivacaine for a penile block for analgesia for hypospadias repair
15796632|NCT04479371|Drug|Bupivacaine|Standard bupivacaine
15796633|NCT04479358|Drug|Tocilizumab|Tocilizumab 40mg
15796634|NCT04479358|Drug|Tocilizumab|Tocilizumab 120mg
15796635|NCT04479358|Other|Standard of Care|Tocilizumab-Free Standard of Care
15796636|NCT04479358|Other|Standard of Care|Tocilizumab 400mg or 8mg/kg
15796637|NCT04479345|Other|Questionnaire|Online questionnaire
15796638|NCT04479332|Procedure|Tracheal intubation and cardiopulmonary resuscitation|Critical patients at the emergency room who require tracheal intubation and/or cardiopulmonary resuscitation will be sequentially allocated to either the resuscitation area or negative pressure isolation room for treatment by the designated medical staff wearing personal protective equipment.
15796639|NCT04479319|Diagnostic Test|Thorax CT|Subjects in all arms have a Thorax CT and RT-PCR for SARS-CoV-2.
15796640|NCT04479306|Drug|Alisertib|Given PO
15796641|NCT04479306|Drug|Osimertinib|Given PO
15796642|NCT04479306|Drug|Sapanisertib|Given PO
15796643|NCT04479293|Other|Post COVID-19 Functional Satus Scale|scale from 0-64 assessing functional limitation
15796644|NCT04479280|Device|Sonclot Coagulation and platelet function Analyzer SCP1, Sienco, USA|studying coagulation disorders in COVID19 critically ill patients
15796645|NCT04479267|Drug|Prednisone|Given PO
15796646|NCT04479267|Drug|Prednisolone|Given IV
15796647|NCT04479267|Drug|Methylprednisolone|Given IV
15796648|NCT04479267|Biological|Rituximab|Given IV
15796649|NCT04479267|Drug|Polatuzumab Vedotin|Given IV
15796650|NCT04479267|Drug|Cyclophosphamide|Given IV
15796651|NCT04479267|Drug|Doxorubicin Hydrochloride|Given IV
15796652|NCT04479254|Dietary Supplement|Enteral Nutrients ( Nutren Optimum, Nutren Diabetes, Novasource Renal ), Parenteral Nutrient ( Smofkabiven)|Enteral nutrition feeding formula is used in powder form and will be reconstituted by attending nurses, Continuous feeding is commonly used which will be prescribed by the attending clinicians, Energy and protein intake from EN will be estimated by multiplying the volume of feed given to energy (kcal) and protein (g) in 1 ml of standard dilution, and for Standard PN product, energy and protein intake will also be calculated based on the volume infused.
15796653|NCT04479241|Biological|PVSRIPO|PVSRIPO (5x10^7 TCID50) delivered intratumorally via convection enhanced delivery (CED).
15796654|NCT04479241|Biological|pembrolizumab|Pembrolizumab (200 mg IV) given every 3 weeks.
15796655|NCT04479228|Device|Endosonography guided transmural drainage|The procedures would be performed by experienced endoscopists. All procedures will be performed with the patient in the left lateral position under propofol sedation after administration of intravenous antibiotics (third generation cephalosporins) A therapeutic linear echo-endoscope (UCT-180; Olympus Ltd, Tokyo, Japan) will be used; the PFC assessed for size, wall maturity, thickness, interposing collaterals and percentage of solid debris
15796656|NCT04479202|Drug|Berberine|Patients in the intervention group received berberine daily, regardless of gastrointestinal symptoms.If the patient has a serious drug-related adverse event, the drug will be discontinued and the patient will be excluded from the study.
15796657|NCT04479202|Drug|Montmorrillonite|Patients in the control group were routinely not given special treatment.However, if the patient has diarrhea symptoms, montmorillonite powder should be given orally.
15796659|NCT04479163|Biological|Convalescent Plasma|250 ml Convalescent plasma with an IgG titer against SARS CoV2
15796660|NCT04479163|Other|Placebo|Normal Saline 0.9%
15796661|NCT04479137|Diagnostic Test|PCR for COVID-19|Novel Coronavirus 2019 DNA will be analyzed by PCR in nasopharyngeal swab
15796662|NCT04479124|Diagnostic Test|COVID-19 PCR|Nasopharyngeal samples were analyzed by PCR for the detection of Novel Coronavirus 2019 DNA
15796740|NCT04478305|Drug|Duavive 0.45Mg-20Mg Tablet|Duavee, marketed as Duavive in Canada.
15796663|NCT04479111|Procedure|laparoscopic ileocecus-sparing right hemicolectomy|The ileocecal artery(ICA) is skeletonized. The colic branch of ICA is divided and ligated. Preserve anterior cecal artery, posterior cecal artery and ileocecal branch of ICA. Divide and ligate the right colic artery(RCA) and middle colic artery(MCA) at their roots. Dissect the lymph nodes surrounding the ICA, RCA and MCA accordingly. Head-to-Head colocolic anastomois is done, with circular stapler via making an opening at the bottom of cecum.
15796664|NCT04479098|Other|Resistance exercise training|The exercise training program will last 12 weeks, with a frequency of three sessions per week, held on Mondays, Wednesdays, and Fridays. Each session will last approximately 50 minutes. Whenever the maximum number of pre-established repetitions is successfully performed, the intensity will be increased by 5 to 10%. All sessions will be supervised by trained professionals.
15796665|NCT04479098|Other|Exercise detraining|The exercise detraining will last 12 weeks without exercise.
15796666|NCT04479085|Other|nursing intervention|"training to organize a home environment. Examination of humidity and temperature changes in the home with a heat-moisture meter.
~giving antiallergic duvet cover set.
~heat-humidity measurement diary symptom diary"
15796667|NCT04479085|Other|standard of care|"Examination of humidity and temperature changes in the home with a heat-moisture meter.
~heat-humidity measurement diary symptom diary"
15796668|NCT04479072|Drug|Aspirin 81 mg|Subjects in the interventional arm will receive a daily dose of aspirin 81 mg, starting at their baseline visit and to be taken up to their 6-month follow-up visit.
15796669|NCT04479072|Drug|Placebo|Subjects in this group will receive a daily dose of a placebo pill, starting at their baseline visit and to be taken up to their 6-month follow-up visit.
15796670|NCT04479059|Other|follicular fluid flushing|Follicular fluid obtained during OPU will be used for endometrial cavity flushing.
15796671|NCT04479046|Other|PMMA crowns|New type of pediatric crowns
15796672|NCT04479033|Other|Multidisciplinary collaborative model of community care management|An individualised care plan is developed for PLWDs-caregiver dyads who meet/communicate weekly with various members of the HMDCS team depending on the nature of their needs. Each dyad's care plan involves the diagnosis of problems (eg: memory problems, family conflicts, poor nutrition, fall risk, medication compliance, lack of long-term care arrangements), establishment of treatment goals (eg: caregiver education, awareness of long-term care planning, stabilising medical care at home, improving emotional support), and indicating specific interventions (eg: referrals to counsellors, specialist doctors, day rehabilitation centres; consultations at GP clinic; coordination of advanced care planning; installation of home safety devices; training caregivers to detect acute deterioration in PLWDs). Monitoring of the dyads' statuses and updating of care plans are performed throughout the duration of the programme.
15796673|NCT04479020|Device|Mechanical Thrombectomy|Mechanical thrombectomy requiring the use an APERIO® or APERIO® Hybrid(17) Thrombectomy device due to an thrombotic occlusion in a distal vessel of the anterior and posterior circulation (postbifurcal MCA, ACA, PCA)
15796674|NCT04479007|Device|Probe based optical techniques|During the intervention of inspecting the airways, different segments of the alveolar compartment will be imaged by two different probe based (CLE and OCT).
15796675|NCT04478994|Biological|TEPEZZA|TEPEZZA is a fully human anti-IGF-1R mAb. TEPEZZA will be provided in single-dose 20 mL glass vials as a freeze-dried powder. Each vial of TEPEZZA must be reconstituted with 10 mL of water for injection. Reconstituted TEPEZZA solution must be further diluted in 0.9% (w/v) sodium chloride (NaCl) solution prior to administration. TEPEZZA will be administered in 100 mL or 250 mL infusion bags (100 mL infusion bags for doses up to 1800 mg and 250 mL infusion bags for doses > 1800 mg).
15796676|NCT04478994|Other|Placebo|Placebo will consist of normal saline (0.9% NaCl) solution and will be administered in 100 mL or 250 mL infusion bags, as would be appropriate, per weight-based dosing volumes (100 mL infusion bags for doses up to 1800 mg and 250 mL infusion bags for doses > 1800 mg).
15796677|NCT04478981|Other|No intervention|This concerns a natural history study; no interventions will be used
15796678|NCT04478968|Other|presence of AVF|Functioning AVF may have cardiotoxic potential
15796679|NCT04478955|Diagnostic Test|Schirmer test|Tear tests Meibomian gland grading test
15796680|NCT04478942|Drug|Misoprostol Oral Product|Misoprostol will be dosed using the preexisting UnityPoint Health-Meriter Protocol for oral misoprostol administration.
15796681|NCT04478942|Drug|Intravenous Oxytocin|Intravenous oxytocin administration will also follow standard, UnityPoint Health-Meriter Protocol.
15796682|NCT04478929|Diagnostic Test|Gastroscopy|Routine gastroscopy
15796683|NCT04478903|Other|Questionnaire|Zarit Burden Inventory French version and SF12
15796684|NCT04478890|Diagnostic Test|Hemodynamic assessment|Hemodynamic assessment of the right ventricle using pressure-volume loop catheter and pulmonary artery catheter
15796685|NCT04478851|Behavioral|Group Exercise Classes|The exercise program to be implemented for rural cancer survivors will combine aerobic, resistance, balance, and flexibility exercises delivered in a circuit-type class setting or group personal training format, twice weekly for a 12-week period. If public health restrictions require closure of fitness facilities due to COVID-19, the program will be delivered online. If facilities are open, the sessions will be integrated in the community, delivered in-person. Whether delivered in-class or remotely, the program follows exercise progression principles (ie, frequency, intensity, time, type, overload and progression) over the 12-weeks, with tailoring of any exercise to meet individual participant needs as required, in order to promote fitness and wellness benefits. The exercise intervention is based on the Alberta Cancer Exercise (ACE) program.
15796686|NCT04478838|Drug|Risperidone|0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg Tablets
15796687|NCT04478838|Drug|Olanzapine|2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, 20 mg Tablets
15796688|NCT04478825|Drug|BBT-401-1S|BBT-401-1S, 8 weeks, once a day
15796689|NCT04478812|Diagnostic Test|Single Group Assignment|Tbit™ System will detect S100B and GFAP concentrations with the blood specimen collected
15796741|NCT04478292|Drug|Sodium Thiosulfate Injection|Weight ≥ 10 kg: 20 g/m2/dose STS or Weight 5-10 kg: 15 g/m2/dose STS or Weight < 5 kg: 10 g/m2/dose STS will be administered by IV over 15 minutes beginning 6 hours after the completion of each cisplatin infusion.
15796742|NCT04478292|Procedure|Primary surgery resection|Resection of the primary tumor up-front
15796743|NCT04478292|Drug|mono CDDP-Group A2|Cisplatin 100 mg/m2/dose Day 1 . All non-WDF patients (A2) will receive 2 cycles of mono cisplatin (100 mg/m2/dose) chemotherapy. Each cycle lasts 3 weeks (21 days).
15796690|NCT04478799|Device|Transcutanous Posterior Tibial Nerve Stimulation|children were managed by bilateral TPTNS following the procedure described in 2006 by Queralto et al(11). A positive auto-adhesive electrode was applied 1.5 inch above the medial malleolus over the S3 dermatome. A second negative electrode was applied just below the same malleolus. Electrical stimulation device (EMS physio Ltd, OX129 F, England) was connected to both electrodes. This device delivers a low frequency current (10 Hz), and the intensity was gradually increased till flexion of the big toe or spread out of the other toes in a fan shape occurred. Then the intensity was lowered to (10 Hz) again to avoid the motor response of the toes. Intensity was determined by the child's sensitivity. The procedure was done for 20-30 minutes and repeated2 times per week for 3 months
15796691|NCT04478799|Device|Sham Transcutanous Posterior Tibial Nerve Stimulation|Sham transcutaneous stimulation Patients also had twice-weekly 20-30-min sessions for 3 months. The same self-adhesive electrodes as used for group A were employed, placed in a similar position. The stimulator was briefly switched on for 30 s to induce only a minor electrical sensation in the skin, and was then turned off for the rest of the treatment. This short duration was given for only for a few seconds to avoid lower limb stimulation. Patients in all TWO groups were told that they may or may not have any perception of the electrical stimulation. Without prior knowledge of what to expect from treatment, this enabled the sham group to act as a control. In order to improve on the blinding effect of the study, the electronic display window of the stimulators was shielded from the patients in the TWO groups. All patients underwent therapy in individual screened cubicles to prevent comparison between patients of the treatment being administered.
15796692|NCT04478786|Other|Focus group discussion|There is no intervention. This is a qualitative piece of work only.
15796693|NCT04478773|Procedure|MRI|MRI with or without contrast
15796694|NCT04478747|Procedure|TVM|Transvaginal mesh operation using BSC mesh (A.M.I., Feldkirch, Austria)
15796695|NCT04478747|Procedure|Colposacropexy|Colposacropexy using EndoGYNious mesh (A.M.I., Feldkirch, Austria)
15796698|NCT04478721|Drug|Temocillin|The intervention of experimental arm will be Intravenous administration of temocillin.
15796699|NCT04478721|Drug|Meropenem|The intervention of comparator arm will be intravenous administration of meropenem.
15796702|NCT04478695|Drug|AMG 330|Continuous intravenous (IV) infusion.
15796703|NCT04478695|Drug|Pembrolizumab|Intravenous (IV) infusion.
15796704|NCT04478682|Other|Breastfeeding Support Provided to Mothers Through WhatsApp Messaging Application|Breastfeeding support provided to mothers through WhatsApp messaging application will be maintained for the first 6 months after birth. In the first 1 month, standard information sharing will be made through whatsApp. Also, for the first 6 months, solutions generating shares will be made according to the problems and questions of the mother regarding breastfeeding.
15796705|NCT04478656|Biological|BBV121|BBV121 or Placebo are administered intramuscularly in deltoid region on Day 0 and 28
15796706|NCT04478643|Dietary Supplement|Probiotic: Lactobacillus Reuteri|Lactobacillus reuteri ATCC PTA 5289 (a minimum of 2 × 108 colony-forming units L. reuteri Prodentis/lozenge, BioGaia AB)
15796707|NCT04478643|Dietary Supplement|Placebo|Placebo lozenge. Will be identical in taste, texture and appearance to the Probiotic one.
15796708|NCT04478630|Other|Peppermint Essential Oil, Ginger Essential Oil, or Pure Vanilla Extract|Inhaled Aromatherapy via a pocket sized diffuser which contains one of the following:Peppermint Essential Oil, Ginger Essential Oil, or Pure Vanilla Extract (placebo-control).
15796709|NCT04478617|Drug|Metronidazole Vaginal|Vaginal metronidazole 0.75% (MetroGel or Vandazole) will be inserted per vagina days 1 through 5 prior to date of surgery.
15796710|NCT04478604|Other|applied forms to pregnant women|
15796711|NCT04478591|Other|Questionnaires|All participants will fill in two questionnaires before or during their next treatment with ocrelizumab: the MSIS-29 questionnaire and a wearing-off questionnaire. After two weeks, participants fill in two digital questionnaires (MSIS-29, additional wearing-off questionnaire).
15796712|NCT04478565|Other|Indirect Calorimetry|"RMR was calculated by breath oxygen consumption (O2 in mL·min-1), minute by minute, using a portable device (Breezing®, Arizona, USA), and the Weir equation (1949), while participants remained in a sitting position for ≈15 to 20 minutes.
~The anthropometric measurements were performed by certified level 3 anthropometrists following the guidelines of the International Society for the Advancement of Kinanthropometry, ISAK"
15796713|NCT04478552|Procedure|Fascia iliaca compartment block|It involves injecting local anaesthetic agent (levobupivacaine) into the fascia iliaca compartment of the patient, infiltrating three major nerves that supply the medial, anterior and lateral thigh, namely the femoral and lateral femoral cutaneous nerves. This procedure can be done with anatomical landmark approach or under image guidance.
15796714|NCT04478552|Procedure|Placebo injection|same volume of normal saline, instead of levobupivacaine, will injected using the same technique.
15796715|NCT04478539|Device|Extracorporeal blood purification using the oXiris® (AN69ST) hemofilter|"Admitted patients will receive at least 1 cycle of extracorporeal blood purification using the oXiris® (AN69ST) hemofilter (Baxter, IL, USA). The number of cycles of blood purification is determined based on multiple biochemical, immunological, coagulation parameters, radiological imaging and overall clinical condition.
~The patient is connected to the Prismaflex® oXiris® system via a double lumen catheter placed in the femoral vein or vena subclavia.
~Flow rates will be maintained as follow; effluent dose 35 mL/Kg/h, dialysate 14 - 16 mL/Kg/h, blood 150 mL/min, replacement 16 -18 mL/Kg/h; patient fluid removal is tailored to the individual's volume status, ≈ 100 - 250 mL/h.
~The oXiris® extracorporeal and organ support modality will be chosen according to the patient's kidney function; continuous venovenous hemofiltration (CVVH), continuous venovenous hemodiafiltration (CVVHDF) or slow continuous ultrafiltration (SCUF)."
15796744|NCT04478292|Drug|Cisplatin, 5-Fluorouracil, Vincristine, Doxorubicin-Group C|All the patients in Group C (2 arms) will receive 6 cycles chemotherapy in total. Cisplatin 100 mg/m2/dose Day 1; 5-Fluorouracil 600 mg/m2/dose Day 1; Vincristine 1.5 mg/m2/dose Day 1,8 and 15; Doxorubicin 30 mg/m2/dose Day 1 and 2; (Dexrazoxane : 300 mg/m2/dose Day 1 and 2, where is available)
15796716|NCT04478526|Drug|SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors)|If never taken SSRI or SNRI, commence primary medication arm (SSRI: sertraline, escitalopram or Pregabalin/SNRI: duloxetine, venlafaxine) will be described to patient and will begin either. If deemed unresponsive to either prior to study, commence medication they have not been previously unresponsive to. Unresponsive if GAD did not improve after treatment with maximum tolerated dose for 8-weeks. If deemed unresponsive to SSRI and SNRI/pregabalin, commence secondary medication arm (bupropion/mirtazepine, buspirone/imipramine) with both being described to patient and begin either. Switch protocol: If unresponsive after 4 or 6 weeks, switch to another class. If started in primary or secondary and not previously demonstrated non-response to second class of medications within arm, switch to second class within arm. If started in primary and previously deemed unresponsive to second class, begin secondary if non-response indicates switch necessary.
15796717|NCT04478526|Behavioral|Electronic Cognitive Behavioural Therapy|Weekly sessions of e-CBT through OPTT will consist of approximately 30 slides. Each session is expected to last approximately 50 minutes. The content and format of each weekly online session was designed to mirror live CBT. The slides will highlight a different topic each week and include general information, an overview of skills and homework on that topic. The homework included in each session will be submitted through OPTT and reviewed by the clinicians with personalized feedback provided by clinicians within three days of submission. Weekly homework submission for feedback will be mandatory before being eligible for the next session. Biweekly GAD-7, DASS-42 and Q-LES-SF questionnaires will be completed through OPTT. A second STAI will be completed in the final week of e-CBT treatment.
15796718|NCT04478513|Drug|AZD4635|During each treatment period subjects will receive a single dose of AZD4635 under fasting conditions.
15796719|NCT04478513|Drug|Fluvoxamine|Daily oral single doses of fluvoxamine are planned to be administered to healthy volunteers in Treatment Period 2.
15796720|NCT04478500|Drug|Minocycline|"Participants will be randomly assigned to receive either Minocycline 100mg twice daily or Placebo.
~Comprehensive testing will be performed at baseline, and at the end of the 12 week intervention phase."
15796721|NCT04478487|Dietary Supplement|Medolac human milk based human milk fortifier (MHMHMF)|MHMHMF is admixed with expressed or donor human milk in graded doses according to tolerated feed volume according to established guidelines and maintain adequate micronutrient levels.
15796722|NCT04478474|Drug|Ganciclovir|Type of allogeneic transplant, HLA match, graft manipulation, use of ATG and/or Campath, CMV status (donor and recipient), maximal acute GVHD stage and grade, CMV viremia/disease through day +100, days received ganciclovir prophylaxis, adverse events related directly or secondary to ganciclovir prophylaxis.
15796723|NCT04478461|Drug|PD-1 monoclonal antibody|"The enrollment mainly depends on 3+3 principle. A total of 3 or 4 dose groups will be evaluated during the dose escalation period: 1, 3, 10 mg/kg, and maybe an additional fixed dose (e.g., to evaluate 200 mg or other fixed dose as RP2D). The drug is scheduled to be administrated Q3W"
15796724|NCT04478448|Drug|Flupirava|1 tablet contains 200 mg Favipiravir
15796725|NCT04478448|Drug|Avigan|1 tablet contains 200 mg Favipiravir
15796726|NCT04478435|Other|glucose loaded clear fluid|Ultrasound assessment of gastric antrum is done at different time interval following glucose loaded clear fluid ingestion
15796727|NCT04478422|Other|Muscle strengthening with vascular occlusion|The muscle strengthening group with partial vascular occlusion will perform the strengthening exercises: single leg squat on 25 ° inclined plane, eccentric + isometric + concentric quadriceps exercise and deep squat. The equipment for vascular occlusion will be positioned over the proximal portion of the lower limb to be treated, just below the gluteal fold and inguinal ligament (Tennent et al. 2017). The pressure must be maintained during all series of exercises (approximately 5 minutes) (Bryk et al. 2016; Ferraz et al. 2018; Giles et al. 2017). If necessary, the pressure can be adjusted at intervals and after the end of the exercise, an interval of 5 minutes is suggested for blood reperfusion.
15796728|NCT04478422|Other|Conventional muscle strengthening|The conventional muscle strengthening group perform the same exercises as the intervention group: One-legged squat on a 25 ° inclined plane, eccentric + isometric + concentric quadriceps exercise and deep squat, however, without restriction on blood flow.
15796729|NCT04478409|Biological|one additional blood sample during a planned blood test|The study does not change the usual course of care. Only an additional blood sample (4 ml for children under 12 and 10 ml for children 12 and over and adults) during a planned blood test is specific to research (no risk added). The benefit / risk balance therefore remains unchanged with regard to the usual care of patients.
15796730|NCT04478383|Procedure|a new transosseous suture technique|a new technique using the spur base on the insertional site to drill the suture tunnel to repair Achilles sleeve avulsion.
15796731|NCT04478370|Biological|Mosquito bites|"Participants will be exposed to mosquito bites.
~For the low-dose challenge, five 5 to 7-day-old nulliparous female imagoes (i.e. that have never blood fed before) will be introduced individual into 50 mL plastic tube covered with netting material.
~For high-dose challenge, 47 mosquitoes will be split into four plastic cups of 10 cm in diameter covered with netting material (three cups with 12 mosquitoes and one cup with 11 mosquitoes), and 3 mosquitoes will be introduced individually into 50 mL plastic tubes.
~Mosquito bites administered on participant's arm will be used to assess immediate and delayed skin reactions. Immediate and delayed skin reactions will be recorded respectively 20-30 min and 24-36 hours after the day 14 and day 21 challenges, requiring additional visits at day 15 and 22."
15796732|NCT04478357|Drug|4 mg Fesoterodine ER tablet from Zwickau|Manufactured at Zwickau
15796733|NCT04478357|Drug|4 mg fesoterodine ER tablet from Freiburg|Manufactured at Freiburg
15796734|NCT04478357|Drug|8 mg fesoterodine ER tablet from Zwickau|Manufactured at Zwickau
15796735|NCT04478357|Drug|8 mg fesoterodine ER tablet from Freiburg|Manufactured at Freiburg
15796736|NCT04478344|Other|Ultrasound guided hydrodissection of superior cluneal nerve|Intervention procedure: hydrodissection to the superior cluneal nerve entrapment Device for guidance: high-resolution ultrasound Drug: 5% dextrose 4 mL + 1% xylocaine 1 mL
15796737|NCT04478331|Behavioral|Technology-based physical activity interventions|The technology groups will receive a PA program for 12 weeks. These PA programs will be given twice a week and include: 5-10 minutes of warm-up, 20-40 minutes of aerobic exercise and muscle strengthening via circuit training composed of 8-10 exercises with 8-12 repetitions per exercise for 2-3 series, and 5-10 minutes of stretching. In addition, advice and counseling will be given about walking activities to achieve the recommendations.
15796746|NCT04478292|Procedure|Resection or transplant|Ideal timing to resect of the primary tumors or transplant if if excellent response achieved at 1st or 2nd evaluation timepoint. But surgery timing is not mandated. Irrespective of the timing of surgery, patients should complete all planned protocol cycles of chemotherapy (including post transplantation). If surgical resection of the primary tumor is delayed until the end of therapy, no further post-operative chemotherapy should be given.
15796747|NCT04478292|Procedure|Resection of pulmonary nodules|Resection of pulmonary nodules should be considered in Group D2, patients at any cycle if continuing to respond to consolidation therapy.
15796748|NCT04478292|Drug|mono CDDP- Group B|Cisplatin 80 mg/m2/dose Day 1. All patients in Group B (2 arms) will receive 6 cycles of mono cisplatin chemotherapy. Each cycle lasts 2 weeks (14 days).
15796749|NCT04478292|Drug|Block 1 to 3 (Cisplatin, Doxorubicin) Group D|Block 1 and 2: Cisplatin 70 mg/m2/dose Day1, 8 and 15; Doxorubicin 30 mg/m2/dose, Day 8 and 9; (Dexrazoxane: 300 mg/m2/dose Day 1 and 2, where is available); Block 3: Cisplatin 70 mg/m2/dose Day1and 8; Doxorubicin 30 mg/m2/dose Day 8 and 9; (Dexrazoxane BSA ≥ 0.6 m2/dose: 300 mg/m2/dose Day 8 and 9, where is available) All patients in Group D will receive 3 blocks in induction, followed by consolidation therapy. Block 1 and 2 last 28 days. Block 3 is 21 cycles.
15796750|NCT04478292|Drug|Consolidation (Carboplatin, Doxorubicin) -Group D1|Following Block 1-3 of induction therapy, Group D1 patients will receive 3 cycles of Carboplatin + Doxorubicin consolidation therapy. Each cycle lasts 3 weeks (21 days). Carboplatin 500 mg/m2/dose Day 1; Doxorubicin 20 mg/m2/dose Day 1 and 2; (Dexrazoxane: 200 mg/m2/dose Day 1 and 2, where is available).
15796751|NCT04478292|Drug|Consolidation (Carboplatin +Doxorubicin/Vincristine + Irinotecan)-Group D2|"Following Block 1-3 of induction therapy, patients in Group D2, will receive 6 cycles of consolidation chemotherapy with Carboplatin + Doxorubicin in Cycles 1, 3, and 5 alternating with Vincristine + irinotecan in Cycles 2, 4, and 6. One cycle of therapy lasts 3 weeks (21 days). Cycle 1, 3 and 5: Carboplatin 500 mg/m2/dose Day 1; Doxorubicin 20 mg/m2/dose Day 1 and 2; (Dexrazoxane: 200 mg/m2/dose Day 1 and 2, where is available).
~Cycle 2, 4 and 6: Vincristine 1.5 mg/m2/dose, Day 1 and 8; Irinotecan 50 mg/m2/dose, Day 1 to 5;"
15796752|NCT04478279|Drug|ST101|ST101 will be administered intravenously (IV), initially once per week with a flat dose on the schedule described for each study arm
15796753|NCT04478266|Drug|Amcenestrant-matching placebo|Pharmaceutical form: Tablets Route of Administration: Oral
15796754|NCT04478266|Drug|SAR439859|Pharmaceutical form: Tablets Route of Administration: Oral
15796755|NCT04478266|Drug|Palbociclib|Pharmaceutical form: Capsules/Tablets Route of Administration: Oral
15796756|NCT04478266|Drug|Letrozole|Pharmaceutical form: Tablets Route of Administration: Orally
15796757|NCT04478266|Drug|Goserelin|Pharmaceutical form: Depot Injection Route of Administration: Subcutaneous
15796758|NCT04478266|Drug|Letrozole-matching placebo|Pharmaceutical form: Tablets Route of Administration: Orally
15796759|NCT04478253|Device|HypnoVR|Insertion of the drain according to the usual management protocol supplemented by the use of a hypnosis software application (HYPNO-VR).
15796760|NCT04478240|Behavioral|PeerLearning.net|"PeerLearning.net is a software package that supports teachers in designing and delivering peer learning lessons, either in-person or remotely while students are learning at home.
~Peer learning is an instructional technique that puts students in groups under conditions of positive interdependence, where they are incentivized to work together and promote the success of one another. Peer Learning lessons also ensure individual accountability and explicitly observe for and reward specific group social skills (e.g., encouraging participation, checking for understanding). Peer Learning also includes group processing after the lesson is completed so that the students in the groups have an opportunity to discuss what they did well and what could use improvement; they also have the opportunity to provide positive reinforcement to one another for contributing to the success of the group."
15796761|NCT04478227|Drug|Romiplostim|Nplate is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) who have had an insufficient response to corticosteroids, immunoglobulins, or splenectomy.
15796762|NCT04478201|Other|back sleep positioning|sleeping on the back.
15796763|NCT04478201|Other|side sleep positioning|sleeping on the side
15796764|NCT04478188|Other|Measuring Pressure Volume Loop Pre and Post Device Placement|To measure simultaneous pressure and volume of the heart (pressure volumes loops) before and after ventricular assist device placement for cardiogenic shock (a severe form of heart failure) and before and after device removal.
15796765|NCT04478175|Other|multidisciplinary assessment and intervention|early multidisciplinary assessment and intervention in addition to usual patient care
15796766|NCT04478162|Other|Supporting parents who have premature babies to be ready for discharge with the training given within the scope of FICare model.|At least 1 week of FICare training for parents At least 4 hours of training on FICare for health professionals Trainings will be held between 13:30 and 15:30 in a training room with heat, light and seating arrangement (for parents who are not able to participate in the training during the week, trainings will be held at the appropriate time interval on the weekend .) Premature baby dummy on oral care, eye care, nose care, ear care, skin care, bath, attired in clothes,/removal, safe sleeping baby, safe transport, kangaroo care (physical contact), non-invasive drug application will be shown and the parents also will be asked to implement,
15796767|NCT04478149|Device|SafelyYou|technology to detect and prevent falls
15796768|NCT04478149|Other|Control|technology present but not activated
15796769|NCT04478136|Diagnostic Test|Blood test of factor levels|Blood draw from central line to check coagulation factors
15796770|NCT04478123|Drug|Romiplostim|Romiplostim 3.0 mcg/kg SC on Day +1 and Romiplostim 2.0 mcg/kg SC on Day +8 after HDT-AHCT. Beyond Day +8, patients will be treated weekly until platelet count is >50,000/mcL, without any platelet transfusions in the prior 48 hours. All doses after the second Romiplostim dose will be titrated as per Table 3, based on weekly CBC/platelet counts. Patients will receive a maximum of six weekly doses of romiplostim.
15796814|NCT04477759|Drug|Atezolizumab|Atezolizumab (840mg) will be given to all subjects by intravenous injection at radiation fractions 1 and 11. Atezolizumab (1,680 mg) will be given to all subjects by intravenous injection every 4 weeks following the end of radiation treatment up to 1 year from radiation fraction 1.
15796815|NCT04477733|Drug|Butorphanol Injection|Inject 10 μg/kg of butorphanol, then propofol is injected until the patient's eyelash reflex disappears before performing colonoscopy
15796771|NCT04478110|Behavioral|interactive group education, navigation services and engagement of health care providers for referrals, and linkage to care.|The interactive group education was aimed to increase participant overall understanding of CRC, screening methods, and utilization of available resources such as home test kit and navigation services, with the ultimate goal of increasing screening rates. Clinical partners provided clinical support and ensured successful screening assessment and follow-ups by offering more flexible hours of clinic operation with bilingual medical staff on site. Patient navigation assistance was also offered based on participants' needs. The range of assistance included scheduling appointments with clinical partners for sigmoidoscopy/colonoscopy for screening and diagnosis after a FIT positive result, assisting paper.
15796772|NCT04478110|Behavioral|Education Session on General Health|Participants in the control group received a group education session in a similar format with that of the intervention group delivered by trained Korean community health educators. Different from the intervention group, the education focused on general health education and primary prevention issues, including routine health examinations and screening for various diseases such as cancer. Korean version of work and communication with a physician, and arranging transportation. standard printed materials and guidelines related to the education contents were also provided, including CRC screening guidelines.
15796773|NCT04478097|Drug|CKD-330 Tab. and D086 Tab.|1T
15796774|NCT04478097|Drug|CKD-333 Tab.|1T
15796775|NCT04478084|Biological|Purified vero rabies vaccine - serum free|Pharmaceutical form:freeze-dried Route of administration: intradermal
15796776|NCT04478084|Biological|Purified inactivated rabies vaccine|Pharmaceutical form:freeze-dried Route of administration: intradermal
15796777|NCT04478084|Biological|Equine rabies immunoglobulins (ERIG) (only Group 3 and Group 4)|Pharmaceutical form:liquid/solution in 5 mL vials Route of administration: intramuscular
15796778|NCT04478084|Biological|Human rabies immunoglobulins (HRIG) (only Group 5 and Group 6)|Pharmaceutical form: liquid/solution in 2 mL vials Route of administration: intramuscular
15796781|NCT04478058|Behavioral|Live CBT|Weekly in-person Cognitive Behavioural Therapy
15796782|NCT04478058|Behavioral|e-CBT|Weekly online Cognitive Behavioural Therapy
15796783|NCT04478032|Device|deep transcranial magnetic stimulation with H7 coil|low frequency(1Hz) deep transcranial magnetic stimulation on ACC .Duration:20 days.
15796784|NCT04478019|Drug|10% Povidone-iodine nasal decolonization swab plus 0.12% CHG oral rinse|2 swab sticks of 10% povidone-iodine in each nares and 0.12% CHG oral rinse
15796785|NCT04478006|Genetic|RNA-seq|Gene expression and fusion transcripts analysis
15796786|NCT04478006|Genetic|whole exon sequencing|Genetic alternation analysis
15796787|NCT04478006|Other|Cytogenetics test|Remission and relapse are monitored by cytogenetic analyses.
15796788|NCT04477993|Drug|Janus Kinase Inhibitor (ruxolitinib)|5 mg P.O. b.i.d. for 14 days. Dose reduction will occur if neutrophils < 500/mm3 or platelets <50,000/mm3.
15796789|NCT04477993|Other|Placebo|Placebo tablets P.O. b.i.d. for 14 days.
15796790|NCT04477980|Other|Disease outcome (mortality)|Mortality rate between the two groups
15796791|NCT04477967|Other|No intervention|There are no interventions because it is a protocol study
15796792|NCT04477954|Combination Product|Hyperbaric Oxygen|Hyperbaric oxygen therapy (HBOT): inhalation of pressurized oxygen through a hyperbaric chamber (Revitalair430)
15796793|NCT04477928|Diagnostic Test|Sera and whole blood sampling|"Study Entry: Single Nucleotide Polymorphism (SNP)-Based Genetic Risk Score at study entry.
~2 years old: T1D autoantibodies, Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) antibodies
~5 years old: T1D and celiac autoantibodies, SARS-CoV-2 antibodies."
15796794|NCT04477928|Diagnostic Test|Differential Gene Expression (DGE)|"Birth: SNP-Based Genetic Risk Score, Differential Gene Expression.
~12 months old: Differential Gene Expression, T1D autoantibodies, SARS-CoV-2 antibodies.
~2 years old: T1D autoantibodies, SARS-CoV-2 antibodies.
~5 years old: T1D and celiac related autoantibodies, SARS-CoV-2 antibodies"
15796795|NCT04477915|Other|Core exercises|Core stabilization exercise include, plank, lateral plank, swimmer, flutter kick and bridge exercises.
15796796|NCT04477915|Other|Auxiliary respiratory exercises|Auxiliary respiratory exercises include, strengthening and stretching exercises for trapezius, sternocleidomastoideus, pectoralis major and serratus anterior muscles.
15796797|NCT04477902|Other|none - observational|online survey
15796798|NCT04477889|Other|Treatment for COVID-19|Patients treated for COVID-19
15796799|NCT04477863|Other|Follow-up Interview|Non Applicable
15796800|NCT04477850|Drug|Luspatercept|Luspatercept
15796801|NCT04477837|Drug|Apixaban 5 MG|frequency of heavy menstrual bleeding
15796802|NCT04477837|Drug|Rivaroxaban 20 MG|frequency of heavy menstrual bleeding
15796803|NCT04477837|Drug|Edoxaban 60 MG|frequency of heavy menstrual bleeding
15796804|NCT04477837|Drug|Dabigatran 150 Mg Oral Capsule|frequency of heavy menstrual bleeding
15796805|NCT04477824|Diagnostic Test|Diagnostic imaging|Ultrasonography, computerized tomography, magnetic resonance imaging
15796806|NCT04477811|Drug|Vitamin K1|vitamin k1 tablets
15796807|NCT04477811|Drug|Vitamin k2|vitamin k2 45 ug tablets twice daily
15796808|NCT04477811|Other|placebo|placebo tablets
15796809|NCT04477798|Diagnostic Test|PCT-DIA/MS|PCT-DIA/MS will be validated to classify FNA biopsy specimens
15796810|NCT04477772|Biological|JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion|1mg/kg:JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion 3mg/kg:JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion 10mgkg:JS004 , Recombinant humanized IgG4k monoclonal antibody specific to BTLA for injection Intravenous infusion
15796811|NCT04477759|Radiation|50 Gy Radiation Therapy|Ionizing radiation
15796812|NCT04477759|Radiation|55 Gy Radiation Therapy|Ionizing radiation
15796813|NCT04477759|Radiation|60 Gy Radiation Therapy|Ionizing radiation
15796816|NCT04477733|Drug|Saline|Inject saline and propofol until the patient's eyelash reflex disappears before performing colonoscopy
15796850|NCT04477421|Procedure|S-LASIK|Femtosecond laser Insitu keratomileusis
15796818|NCT04477694|Procedure|colonoscopy under sedoanalgesia|Colonoscopy is a widely used method for diagnosing and treating colonic diseasea with a thin, flexible camera.
15796819|NCT04477681|Other|Data collection|In particular, the patient's demographic data, medical history, previous and concomitant treatments, data on the treatment of interest (legal framework, ATU / off-label), dosage, start date, etc.), clinical data will be collected. biological (including molecular profiling of the tumor if available) and radiological follow-up, information on adverse effects. The data to be filled in is that of the CERFA pharmacovigilance form of the ANSM, but additional fields can be created if necessary.
15796820|NCT04477668|Device|Helmet non-invasive ventilation|Patients will be allocated to helmet non-invasive ventilation
15796821|NCT04477655|Procedure|Awake prone positioning|Patients will be asked to remain in prone position or lateral decubitus throughout the day as long as possible.
15796822|NCT04477655|Procedure|Standard oxygen therapy|Oxygen therapy through high flow nasal cannula (HFNC). Inspired fraction of oxygen will be titrated to maintain a capillary saturation of ≥92%
15796823|NCT04477642|Drug|Abatacept|10mg/kg intravenously administered on Day 1
15796824|NCT04477629|Drug|Belatacept|Belatacept will be given in the following way - 10mg/kg IV day 1, 5, end of weeks 2, 4, 8, 12 then 5mg/kg every 4 weeks.
15796825|NCT04477629|Drug|Tacrolimus|Non-experimental: Tacrolimus will be given in the following way - trough level at month 1, 10-12ng/mL; month 2-3, 6-10ng/mL; month 4-6, 4-6ng/mL; months 7-9 taper off.
15796826|NCT04477629|Drug|Mycophenolate Mofetil|Non-experimental: MMF is part of standard of care after heart transplant and will follow dosing recommendations as per standard clinical practice at 500-1500mg twice a day (BID) (dosed to tolerance and effect).
15796827|NCT04477629|Drug|Corticosteroid|Non-experimental: CS is part of standard of care after heart transplant and will follow dosing recommendations as per standard clinical practice at a dose no less than 5mg/d.
15796828|NCT04477616|Drug|Day 7 regimen|patients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 7 after chemotherapy. If FN occurs in the experimental group and the control group, reduce the dose of chemotherapy in the next course of treatment, timely change the chemotherapy regimen, and closely monitor to ensure patient safety. Record the results of routine blood follow-up and temperature curves of patients at different time periods. If WBC >= 15 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle.
15796829|NCT04477616|Drug|Day 3 regimen|patients received a single dose of 6mg of PEG-rhG-CSF(pegfilgrastim), as a single subcutaneous injection on day 3 after chemotherapy. If FN occurs in the experimental group and the control group, reduce the dose of chemotherapy in the next course of treatment, timely change the chemotherapy regimen, and closely monitor to ensure patient safety. Record the results of routine blood follow-up and temperature curves of patients at different time periods. If WBC >= 15 x 10^9/L in the first chemotherapy cycle, then 3mg PEG-rhG-CSF will be used in the second chemotherapy cycle.
15796830|NCT04477603|Device|Impella ECP|Subjects will receive the Impella ECP prior to high-risk percutaneous intervention. Device escalation or early termination of the study will be allowed for subjects as deemed necessary by the treating physician. Subjects will be followed until 30-days post-intervention.
15796831|NCT04477590|Drug|EXERCISE TRAINING WITH OR WITHOUT MEDICATION|A group will train 30 min after taking their habitual dose of medicine (MEDICATED train) while another group will train after taking a placebo (NON-MEDICATED train) and will receive their medication after training.
15796832|NCT04477577|Behavioral|New Parent Intervention|This arm will receive the Obstetric and Pediatric primary care provided within MGH obstetric and pediatric primary care practices, with additional active and targeted engagement of new parents by a health coach.
15796833|NCT04477577|Behavioral|Safety Control|This arm will receive the Obstetric and Pediatric primary care provided within MGH obstetric and pediatric primary care practices, with additional infant safety education materials.
15796834|NCT04477551|Procedure|Diode laser (device) with scaling and root planing|Combined use of diode laser device and scaling instruments to remove plaque and calculus from the surface of the roots of teeth.
15796835|NCT04477551|Procedure|Conventional scaling and root planing|Use of scaling instruments to remove plaque and calculus from the surface of the roots of teeth.
15796836|NCT04477538|Other|Post-mastectomy breast reconstruction physical well-being survey|-The survey will ascertain: function status (BREAST Q - Physical Well Being Module and PROMIS upper extremity function), former interaction with physical or occupational therapy, amount of narcotics taken weekly due to chest/neck/breast pain, amount of Tylenol or similar anti-inflammatories taken weekly due to chest/neck/breast pain, and amount of muscle relaxants taken weekly due to chest/neck/breast pain.
15796837|NCT04477525|Procedure|Ultrasound Guided Erector Spinae Plane (ESP) Nerve Block|The planned intervention is a bilateral erector spinae nerve block for patients undergoing bariatric surgery. This intervention will be performed in the PACU for patients with an NRS pain score >5. All eligible candidates who have consented for this study will be present in the PACU, have all standard ASA monitoring placed. The patient will then be placed in a sitting position. The patient will then be prepped with chlorhexidine in the thoracic region and draped in a sterile fashion. The ultrasound will be brought in over the patient and the T7 Transverse Processes (TP) will be identified. An echogenic needle will be placed under direct ultrasound guidance on the TP. Then, 20 cc of 0.25% bupivacaine will be injected.
15796838|NCT04477525|Drug|Bupivacaine Injection|20 cc of 0.25% bupivacaine will be injected
15796839|NCT04477512|Drug|Cabozantinib|Supplied by Exelixis
15796840|NCT04477512|Drug|Nivolumab|Supplied by Bristol-Myers Squibb
15796841|NCT04477512|Drug|Abiraterone acetate|Commercially available
15796842|NCT04477512|Drug|Prednisone|Commercially available
15796843|NCT04477512|Procedure|Peripheral blood collection|Prior to start of treatment, after 8 weeks of combination therapy, with every subsequent imaging (every 12 weeks), end of treatment
15796844|NCT04477486|Drug|Ibrutinib|Capsule; Oral
15796845|NCT04477486|Drug|Venetoclax|Tablet; Oral
15796846|NCT04477473|Other|Questionnaire-based observational study|"Questionnaire focusing on practical health care issues regarding respiratory support, health status and perception of the COVID-19 issue:
~Symptom score (related to noninvasive ventilation: NIV)
~Thymic disturbances (score of anxiety and depression)
~Compliance to treatment (assessed via tele-monitoring: routine procedure)"
15796847|NCT04477460|Dietary Supplement|Thickened feeds|Thickened feeds directed by medical team
15796851|NCT04477408|Other|plantar sensory exercise group|"plantar sensitive exercises
~Plantar sensitive exercises:
~30 minutes / 3 days per week / 8 weeks Walking on different 4 different textured floors and hot floor (15 minute) Trying to recognize small objects with the soles of the feet (5min) Seated work with barbed ball and balance pad (5min) Massage to the sole of the foot with different textured fabrics (5min)"
15796852|NCT04477395|Dietary Supplement|fish oil|SRP will be supplemented with the dietary fish oil rich in omega-3 PUFAs EPA and DHA for 6 months. Fish oil (BioMarine Medical, 200 ml liquid), obtained from Tasmanian deep sea shark and Norwegian cod liver and sardine, anchovy and mackerel muscle, will be administered two times a day at a dose 10 ml. Daily dose of 20 ml provides 2.6 g of EPA and 1.8 g of DHA.
15796853|NCT04477395|Procedure|SRP only|Scaling and root planing will be the only method of treatment.
15796854|NCT04477382|Dietary Supplement|holo-BLG (beta-lactoglobulin) - a major component of the protein fraction of raw milk, is loaded with ligands such as retinoic acid, zinc and polyphenol-iron complexes.|Subjects suffering from house dust mite (HDM) allergic rhinoconjunctivitis who are reacting positively to chamber exposure with HDM are reevaluated in the exposure chamber 3 months after taking food supplements.
15796855|NCT04477369|Drug|DWJ1439|300mg single dose
15796856|NCT04477369|Drug|DWJ1464|300mg single dose
15796857|NCT04477369|Drug|DWC202003|300mg single dose
15796858|NCT04477369|Drug|DWC202004|300mg single dose
15796859|NCT04477356|Procedure|SU|Aliquot 1.2 ml Ferticult Flushing media (Fertipro, Belgium) into 14 ml tube and then gently add 1 ml semen sample to the bottom of the tube (in case of larger semen volume, use multiple 14 ml tubes). The tubes then will be hold at an angle of 45 degrees for 45-60 minutes at 37C. Collect 1 ml of supernatant and then wash with 2 ml Ferticult Flushing media by centrifugation at 1200 RPM for 10 minutes. Keeping 0.3 ml washed semen for IUI, sperm density counting. Prepared sperms will be transferred into uterus by soft catheter (Gynétics, Belgium).
15796860|NCT04477356|Procedure|DG|Add 1.5 ml Sil-select 90% first and then 1.5 ml Sil-select 45% (Fertipro, Belgium) into centrifuge tube, then gently add 1 - 1.5 ml semen on the top of Sil-select layer and centrifuge at 1200 RPM for 15 minutes. Discard upper layer, collect 0.5 ml lower layer into new tube and then wash with 2 ml Ferticult Flushing media at 1200 RPM for 10 minutes. Discard upper layer then collect 0.3 ml lower layer for IUI, sperm density counting. Prepared sperms will be transferred into uterus by soft catheter (Gynétics, Belgium).
15796861|NCT04477343|Drug|SX-682|Allosteric inhibitor to human CXCR1 and CXCR2 receptor
15796862|NCT04477343|Drug|Nivolumab Injectable Product|humanized monoclonal antibody to program cell death receptor 1 (PD1)
15796863|NCT04477330|Other|Transcranial direct current stimulation (tDCS)|1 mA tDCS
15796864|NCT04477330|Other|Ankle motor training|Visuomotor target tracking task
15796865|NCT04477330|Behavioral|High intensity interval speed based treadmill training (HIISTT)|Each treadmill session to include warm-up, high intensity speed-based intervals interleaved with active recovery, and cool down.
15796866|NCT04477317|Drug|4% Articaine Hydrochloride with 1:100,000 Adrenaline|new Egyptian articane anesthetic solution.
15796867|NCT04477317|Drug|2% Mepivacaine Hydrochloride with 1:20,000 Levonordefrin|Mepecaine-L is the brand name of the Egyptian 2% Mepivacaine. It is the most commonly used anesthetic solution in Egypt due to its availability and its lower cost.
15796868|NCT04477304|Behavioral|Opioid Naive, OR|Visits where the order is for an included opioid and there is no prior opioid prescription with a start date of greater than 1 day and less than 91 days and clinician is on the clinic list as a treating member of the clinic
15796869|NCT04477304|Behavioral|At-risk for long-term use, OR|Visit where the order is for an included opioid, there is a prior opioid prescription with a start date greater than 1 day and less than 91 days, and there is no prior opioid prescription with a start date greater than 90 days and clinician is on the clinic list as a treating member of the clinic
15796870|NCT04477304|Behavioral|Long-term opioid recipient|Total opioid doses are at least 50 MME per day, there are two or more prior opioid prescriptions with two different start dates both greater than 1 day and less than 91 days, and there is a prior opioid prescription with a start date greater than 90 days and less than 181 days and clinician is on the clinic list as a treating member of the clinic
15796871|NCT04477291|Drug|CG-806|CG-806 will be given orally in ascending doses starting at 450 mg PO BID until the maximum tolerated dose or candidate recommended Phase 2 dose is reached.
15796872|NCT04477278|Behavioral|Mindfulness Meditation|The mindfulness meditation recording consisted of instruction in focused attention on breath and body sensations and metacognitive monitoring and acceptance of discursive thoughts, negative emotions, and pain.
15796873|NCT04477278|Behavioral|History of Osteopathy|The history of osteopathy recording introduced patients to the founder of osteopathy, Andrew Taylor Still, and his philosophy of healing.
15796874|NCT04477265|Drug|Solifenacin Succinate 5mg/tab daily|participants will be taking oral medication for 3 months
15796875|NCT04477265|Behavioral|biofeedback-assisted pelvic floor muscle training|participants will be doing biofeedback-assisted pelvic floor muscle training for 3 months
15796876|NCT04477252|Device|App-core|"Farmalarm App of the Inmovens group - Vall d´Hebrón Hospital will be used, adapted and updated by the main researcher. The App will have the rehabilitation option where the user can consult the description of the exercise and view a demonstration video so that it can be carried out correctly at home, independently or with help. The administrator therapist of the App has the permission to create users, contact them directly through chat or video-call and personalize the exercise program.
~The exercises that will be carried out in this study phase, are described in previous studies by the author Rosa Cabanas et al. All possible exercises will be included in the administration platform, and according to of each user, the prescription of some exercises or others will be made."
15796877|NCT04477252|Other|Conventional physiotherapy|Conventional physiotherapy is considered neuromotor development therapy as the most frequently used therapy in the management of stroke patients and in the center where the study is performed.
15796878|NCT04477239|Behavioral|Gluten (behaviour)|Gluten is a protein normally present in the daily diet of healthy volunteers not suffering from gluten related disorders, in far greater quantities (10-20 g/day) than those used in this study (10 mg-1 g/day).
15796879|NCT04477239|Behavioral|Placebo (behaviour)|Placebo is composed of pregelatinized maize starch Ph.Eur. 97.5%; magnesium stearate Ph.Eur. 1.5%; micronized silica Ph.Eur. 0.5%; Micronized talc Ph.Eur. 0.5% (NOT containing preservatives, colorings, or gluten).
15796880|NCT04477226|Diagnostic Test|Transvaginal ultrasound scan|Transvaginal ultrasound is done to measure the cervical length, as per Fetal Medicine Foundation guidelines
15796881|NCT04477200|Drug|Mycophenolate Mofetil|Given PO
15796882|NCT04477200|Radiation|Radiation Therapy|40.5 Gy in 15 fractions
15796883|NCT04477200|Procedure|Re-resection (as part of standard of care)|Re-resection or biopsy of tumor as part of standard of care
15796884|NCT04477187|Device|Dermal Handpiece|Radiofrequency (RF) will travel through the RF generator through the electrodes and into the dermal layer beneath the surface of the skin. The microneedles of the dermal cartridges coupled with the thermal heat will stimulate neocollagenesis and neoelastosis, aiding in the reduction of submental laxity.
15796885|NCT04477161|Dietary Supplement|Ketone Ester Elite endurance Nutrition Drink|Subjects will take one bottle four times daily for four weeks
15796886|NCT04477161|Other|Stool Sample|Subjects will provide a stool sample at 2 timepoints.
15796887|NCT04477148|Device|endotracheal intubation|patients were intubated with 3 different blades
15796888|NCT04477135|Other|upper extremity pain|upper extremity pain in perinatologists due to working actively and performing ultrasonography every day
15796889|NCT04477135|Procedure|ultrasonography|ultrasonography
15796890|NCT04477122|Other|Manual therapy and extracorporeal radial shock waves therapy|25 minutes of manual therapy, 5 minutes of temporomandibular joint mobilization and 3 minutes of extracorporeal radial shock waves therapy (real or placebo)
15796891|NCT04477109|Device|low level laser in addition to diet recommendations|The laser consists of a semiconductor and operates at a wavelength of 650 nanometre. The laser installed in the watch comprises 10 individual laser beams for the wrist and an additional adapter for nasal stimulation. The output power is 5 megawatt
15796892|NCT04477109|Other|sham laser application in addition to diet recommendations|sham laser application in addition to diet recommendations
15796893|NCT04477096|Drug|HS-10234|HS-10234
15796894|NCT04477096|Drug|Emtricitabine|Emtricitabine
15796895|NCT04477083|Drug|inhalable hydroxychloroquine (HCQ)|inhalable hydroxychloroquine (HCQ) plus supportive and symptomatic treatment
15796896|NCT04477083|Drug|supportive and symptomatic treatment|supportive and symptomatic treatment
15796897|NCT04477070|Procedure|Air-polishing with ultrasonic debridement|Use of air-polishing and ultrasonic device (Airflow Prophylaxis Master, EMS, Nyon, Switzerland) to remove plaque and calculus from the surface of the roots of teeth.
15796898|NCT04477070|Procedure|Conventional scaling and root planing|Use of scaling instruments to remove plaque and calculus from the surface of the roots of teeth.
15796899|NCT04477057|Drug|HS-10241|HS-10241 is a tablet in the form of 100 mg, oral, once daily.
15796900|NCT04477044|Other|Study Group|GoPro Hero4 to be mounted on the participant's forehead while performing intubation on a manikin.
15796901|NCT04477018|Dietary Supplement|Iron bis-glycinate chelate and vitamin C|28 mg iron; 240 mg vitamin C
15796902|NCT04477018|Dietary Supplement|Iron bis-glycinate chelate|28 mg iron only
15796903|NCT04477018|Dietary Supplement|Placebo|Matched placebo
15796904|NCT04477005|Device|ERCP and insertion ofBio-degradable bile duct stent|ERCP is an accepted mode of treatment and patients rarely need surgery for bile leaks and bile duct stents. Endoscopic management involves sphincterotomy (cutting open the Sphincter of Oddi) and insertion of a plastic or metal stent. Instead of placing a plastic stent bio-degradable stent will be placed. They will be followed up on Day 1, 7,30, 60,90 and 180 days. they will have abdominal x-ray on day 90 and day180.
15796905|NCT04476992|Drug|Nitric Oxide-Sessions|Nitric Oxide will be delivered at 200 ppm in 2 daily sessions (morning, evening; 9-12 hours apart) for 14 days. Each session will last 30 minutes, for a total of 60 minutes/day for each patient. A tank of NO gas will be connected to the inspiratory limb of the circuit, and the flow will be adjusted to deliver a target concentration of 200 ppm NO. Commercially available tanks will be used to provide the gas. The desired mixture of air, oxygen (O2), and NO will be titrated with the respective flowmeter to reach a concentration of 200 ppm at the inspiratory limb with the desired Fraction of inspired oxygen (FiO2).
15796906|NCT04476992|Drug|Nitric Oxide-Continuous and Sessions|"Nitric Oxide will be delivered at 200 ppm in 2 daily sessions (morning, evening; 9-12 hours apart) for 14 days. Each session will last 30 minutes, for a total of 60 minutes/day for each patient. A tank of NO gas will be connected to the inspiratory limb of the circuit, and the flow will be adjusted to deliver a target concentration of 200 ppm NO. Commercially available tanks will be used to provide the gas. The desired mixture of air, oxygen (O2), and NO will be titrated with the respective flowmeter to reach a concentration of 200 ppm at the inspiratory limb with the desired Fraction of inspired oxygen (FiO2).
~The subjects assigned to the group NO High Concentration + Continuous Low Concentration will receive in adjunction a continuous dose of NO at 20 ppm."
15796907|NCT04476979|Drug|Tocilizumab|Tocilizumab 8mg/kg D1 and if no response (No decrease of oxygen requirement) a second fixed dose of 400mg wil be administered at D3
15796908|NCT04476979|Drug|Dexamethasone|Dexamethasone : 10 mg once daily for the first five days (day 1 to day 5) then 5 mg per day for up to 5 days, 2.5mg per day for up to 4 days (or until oxygen supply independency if sooner)
15796909|NCT04476966|Drug|Bladogra|1 tablet contains 25 mg Mirabegron
15796910|NCT04476966|Drug|Myrbetriq (first dosing)|1 tablet contains 25 mg Mirabegron
15796911|NCT04476966|Drug|Myrbetriq (second dosing)|1 tablet contains 25 mg Mirabegron
15796912|NCT04476953|Drug|Placebo|Placebo looks exactly like the study drug, but it contains no active ingredient.
15796913|NCT04476953|Drug|Fisetin|~20 mg/kg/day oral, NG or D tube course for 2 consecutive days
15796914|NCT04476940|Behavioral|COVID-19 Breastfeeding Support|Intervention will be implemented by trained prenatal care providers to provide comprehensive exclusive breastfeeding and COVID-19 breastfeeding guideline education and support to study participants.
15796946|NCT04476628|Device|Mucosal Atomization Device|MAD is a device used as an addition to a syringe to atomize medication to increase area of distribution. It is used to administer budesonide within the nasal passages and sinuses to administer medication for CRS.
15796947|NCT04476628|Device|NeilMed squeeze bottle for Impregnated Nasal Saline Irrigation|INSI is delivered using a NeilMed squeeze bottle. It is used to administer budesonide within the nasal passages and sinuses to administer medication for CRS.
15797025|NCT04475913|Other|CIG Tilted|received two anterior axial implants and two distal tilted implants, and conventional impression
15796915|NCT04476927|Device|DiaNose|"DiaNose system is an electronic nose device that can smell diseases in the exhaled breath of patients in real time. The recognition of Volatile Organic Compounds (VOCs) in breath samples approach is non-invasive and for safe diagnosis of diseases.
~The DiaNose prototype system consists the following elements:
~A Soft Tube connected to a Sensors Chamber - The soft tube is made of medical grade silicon. The subject blows air into the tube for a few seconds and the exhaled air is directed through the sensors chamber. This unit is for single use.
~Sensors Reading Unit- a multi used unit for sensors signals measurement. The Sensor Reading Unit is connected to a Laptop either via a Data Acquisition Instrument - Commercial unit for resistance measurements (https://www.tek.com/keithley-switching-and-data-acquisition-systems/keithley-daq6510) (option A ) or directly by a USB cable (option B).
~Laptop - Laptop is used to activate and save the test measurements."
15796916|NCT04476901|Biological|allogeneic human mesenchymal stem cells (hMSCs)|allo-hMSCs, 16-20 million cells/ml delivered at a dose of 0.5 ml/ injection x 10 injections for a total of 80-100 million allo-hMSCs
15796917|NCT04476901|Other|Placebo|Placebo will be administered as injections of plasmalyte A supplemented with 1% of 25% human serum albumin (HSA). 0.5 ml/ injection x 10 injections
15796918|NCT04476888|Biological|Convalescent Plasma (CP)|500 ml of Convalescent plasma in a single dose will be transfused over a period of 1- 2 hours.
15796919|NCT04476888|Other|Drugs and supportive care|This will include drugs like steroids, tocilizumab, azithromycin and supportive care
15796920|NCT04476875|Other|Open Outpatient Clinic Programme|
15796921|NCT04476862|Drug|Cerliponase Alfa|Commercially available product provided to patient by participating clinic site.
15796922|NCT04476862|Device|Administration Kit|Commercially available administration kit provided to the patient by participating clinic site.
15796923|NCT04476849|Drug|fezolinetant|Oral
15796924|NCT04476836|Other|Animal-Assisted Therapy|Animal-Assisted Therapy is when animals are used in goal-directed treatment sessions. These goals can be physical, mental, emotional or social.
15796925|NCT04476823|Other|Activity|The questionnaire had requested information on the biosafety organization, impact of the COVID-19 crisis on the clinical and molecular pathology and the biobanking activity in thoracic pathology, on the research activity associated with the COVID-19, and on the educational and training organization. It requested the different needs planned by the different laboratories following the COVID-19 crisis and finally the consequence of this latter on the health and virological status of the staff members.
15796926|NCT04476810|Device|kahook dual blade|Combined Phacoemulsification and Excisional Goniotomy with the Kahook Dual Blade
15796927|NCT04476797|Drug|GC4711|15 minute IV Infusion
15796928|NCT04476797|Drug|Placebo|15 minute IV infusion
15796932|NCT04476771|Behavioral|Feliz-Mente (third generation psychotherapy)|The intervention is delivered in a group format with a total of 12 sessions and a maximum of 10 patients per group. The protocol consists of specific exercises: 1: welcome and identification of emotions, 2: identification and amplification of positive emotions, 3: regulation of negative emotions, 4: gratitude, 5: forgiveness, 6: self-compassion, 7: personal strengths, 8: loving-kindness and positive interpersonal relationships, 9: values, 10: purpose of life, 11: resilience, 12: keeping the change and farewell party.
15796933|NCT04476745|Dietary Supplement|Vitamin D3|Dietary Supplement: Vitamin D3 (50,000) IU / week for 8 weeks
15796934|NCT04476732|Other|Paraben-free skincare product|Paraben-free lotion will be applied twice a day for one week.
15796935|NCT04476732|Other|Paraben-containing skincare product|Paraben-containing lotion will be applied twice a day for one week.
15796936|NCT04476719|Drug|ATAFENOVIR 200 MG KAPSUL|A 200 mg capsule 0ral administration with 240 ml water
15796937|NCT04476719|Drug|ARBIDOL 100 MG KAPSUL|Two 100 mg capsules will be administrated with 240 ml water orally.
15796938|NCT04476706|Drug|canakinumab|canakinumab
15796939|NCT04476693|Other|Breakfast consumption|"Consumption of breakfast: The breakfast provided was designed based on the characteristics of an ideal breakfast outlined in Giovannini et al., (2008). The breakfast provided in the present study will include the following: all-bran cereals (Kellogg's), semi-skimmed milk (Tesco), Royal Gala Apple (Tesco) and Orange Juice from Concentrate (Tesco) containing the amount of carbohydrates usually consumed at breakfast in the UK (Reeves et al., 2013). The portion for each participant will contain 0.06 g of carbohydrate per kcal of measured RMR. As the portion size (20% of daily calorie intake) will be calculated based on individual RMR , no leftovers will be allowed."
15796940|NCT04476693|Other|Breakfast Omission|Omission of breakfast. Participants will consume water within 15 min, the individual volume of which will be calculated based on the liquid content of the breakfast [milk (ml)+ orange juice (ml)].
15796941|NCT04476680|Dietary Supplement|Vitamin D|Pure Encapsulations' manufacturing facility is a US Food and Drug Administration (FDA) inspected and NSF International Good Manufacturing Practices registered company.
15796942|NCT04476667|Behavioral|e-Psychotherapy|Module Content: The first 3 sessions will be designed to address the symptoms caused by fear of illness or concerns about personal safety in the context of pandemic. Electronic-CBT (e-CBT) modules will focus on problem solving techniques, with mindfulness practices included, to help build healthy coping skills to address the uncertainties surrounding the COVID-19 pandemic. e-CBT modules will involve guiding participants to develop constructive and balanced coping strategies through 5 focuses: stimulus control, cognitive therapy, sleep hygiene, relaxation therapy, and sleep restriction. Additional focus will be placed on the connection between thoughts, behaviours, emotions, physical reaction and one's environment.
15796943|NCT04476654|Behavioral|YouTube Video Arm|Participants (n=25) will watch a 20 minute YouTube video that will describe the genetic counseling and testing process and risk/benefit information in a culturally relevant format. Participants will complete pre and post assessments. After the session, participants interested in pursuing genetic counseling and testing services will be referred to a patient navigator who will navigate participants to identified no cost or low cost services.
15796944|NCT04476641|Other|CELL|inject the DC-CIK(dendritic cell activated and cytokine induced killer cell)
15796945|NCT04476628|Drug|Budesonide|Budesonide is a corticosteroid that is commonly used intranasally to treat CRS.
15796948|NCT04476615|Dietary Supplement|Fasting-Mimicking Diet (ProLon®)|Dietary restriction: Fasting-Mimicking Diet (ProLon®). 5-days cycles spaced at 1-month intervals for 3 months (3 cycles in total).
15796949|NCT04476615|Dietary Supplement|Placebo bars|"Dietary supplementation: Low-energy bars (L-Nutra®) to integrate the daily nutritional habits - one bar per day.
~5-days cycles spaced at 1-month intervals for 3 months (3 cycles in total)."
15796950|NCT04476589|Diagnostic Test|Functional MRI|measurement of functional brain networks
15796951|NCT04476576|Behavioral|Aerobic exercise (experimental)|3 times per week, 30 minutes each time. Entrance in heat: 8-10 min of joint mobility and / or the aerobic exercise in the main part at light intensity (OMNI 3-4) Main part: minimum 30 minutes, maximun 60 minutes. Intensity: moderate, guided by Talk Test and effort perception scale 5-6 OMNI. Type: aerobic, cycling or walking at home using a treadmill or exercise bike and / or cycling and walking outdoors according to the patient's possibilities and preferences. Return to calm: 5 min of aerobic physical activity of main part at mild intensity (OMNI 3-4), then static stretching. Pictures with each type of exercise will be offered and detailed explained.
15796952|NCT04476576|Behavioral|Flexibility exercise (active comparator)|Entrance in heat: 10 min of joint mobility. Main part: Minimum 30 minutes. Frequency: 3 times por week Intensity: The patient should be able to slowly stretch the muscle to a position of mild discomfort. Type: Static Stretch Time: 15-30 seconds 2 repetitions of each stretch Number of exercises: 12 . Pictures with each muscle group to exercise will be offered and detailed explained.
15796953|NCT04476563|Diagnostic Test|Obtaining biological samples|Biological samples (blood, urine, stool). Liver tissue will be obtained from ChILI group when clinically indicated
15796954|NCT04476550|Drug|Filgrastim|5 days of daily sub-cutaneous administration of 10mcg/kg filgrastim
15796955|NCT04476537|Other|OncoTreat|OncoTreat is a computational pipeline that begins with a tumor expression profile and ends with a list of several candidate regimens.
15796956|NCT04476524|Other|Quality improvement|All patients with AF as primary problem treated with study protocol would be compared with historical cohort of AF patients who were treated with routine care in the ER. Patients will be followed up and outcomes will be compared between two groups at 1, 3, 6 and 12 months.
15796957|NCT04476511|Drug|Cholecalciferol|tablet containing 30.000IU cholecalciferol
15796958|NCT04476498|Procedure|Pull-PEG with Gastropexy|Additionally to a conventional pull-PEG a gastropexy will be performed.
15796959|NCT04476485|Other|endocrine therapy|If the expression of sj-subway in the surgical wax block is eligible, it is recommended but not mandatory that patients follow the guidelines to choose the appropriate extended endocrine therapy. 1. For postmenopausal patients: Extend treatment with aromatase inhibitors 10 years: letrozole or anastrozole or exemestane. 2. For premenopausal patients: An initial 5 years tamoxifen treatment followed by additional 5 years extended tamoxifen treatment. Postmenopausals are treated with aromatase inhibitors 5 years. 3. For patients have completed ovarian function suppression plus initial 5-year aromatase inhibitor treatment: Menopausals: Aromatase inhibitors; Non-menopausals: 5 years of tamoxifen treatment or ovarian function suppression plus 5 years of aromatase inhibitor treatment. 4. For patients have completed ovarian function suppression plus initial 5-year tamoxifen treatment: Menopausals: Aromatase inhibitors for additional 5 years; Non-menopausals: Tamoxifen for additional 5 years.
15796960|NCT04476472|Device|Omnipod Horizon™ Automated Glucose Control System|The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery.
15796961|NCT04476459|Drug|Camrelizumab|Camrelizumab will be administered every 3 weeks up to 6 cycles during induction phase, and then every 4 weeks up to 12 cycles in maintenance phase if patients get CR or PR after induction phase.
15796962|NCT04476459|Drug|Apatinib|"Phase I: dose escalation phase. Patients will oral dosage as 250mg, 500mg or 750mg,qd, per day. Aim to evaluate MTD and DLT, RP2D.
~Phase II：Patients continuous oral apatinib as RP2D up to 6 cycles during induction phase, and then 250mg/d up to 1 year in maintenance phase if patients get CR or PR after induction phase."
15796964|NCT04476433|Other|Ten Vida (10Vida)|10Vida is a psychoeducational and emotional programme for chronic illness in adolescents and their families.
15796965|NCT04476420|Dietary Supplement|Nigella sativa oil|Using N.sativa oil as an alternative to conventional management will help us to find a treatment option which is non-invasive, cost effective, inexpensive, easy available and belongs to a natural source with almost no side effects.
15796966|NCT04476420|Drug|Betamethasone Valerate|it is a conventionally used drug for treating OSMF
15796967|NCT04476407|Drug|benapenem|single-dose Benapenem 1.0mg(iv), 60min infusion
15796968|NCT04476407|Drug|benapenem|single-dose Benapenem 1.0mg(iv), 60min infusion
15796969|NCT04476407|Drug|benapenem|single-dose Benapenem 1.0mg(iv), 60min infusion
15796970|NCT04476394|Drug|[14C]-Anaprazole Sodium enteric-coated capsule|[14C]-Anaprazole Sodium enteric-coated capsule
15796971|NCT04476381|Procedure|Dry needling|Insertion of a Optimed 40mm x 0.30 single use, sterile acupuncture needle into a active trigger point in the infraspinatus muscle
15796972|NCT04476368|Other|weekly yoga classes|Weekly 90 min pregnancy-adapted yoga classes lead by certified yoga instructors.
15796973|NCT04476368|Other|walk|20-30 min easy walking
15796974|NCT04476355|Other|Select and Tailor implementation interventions|Based on previously adapted guidelines and the assessment of innovation, adopters and practice environment for barriers and supports, the interventions mainly include patients education, practioners education and system changes.
15796975|NCT04476342|Device|minimal invasive cardiopulmonary bypass (MICPB) system|The experimental group was MICPB group, with built-in micro-thrombotic oxygenator and MP formula (15mL 15%KCl+10ml compound potassium, calcium and magnesium +25ml normal saline)
15796976|NCT04476329|Drug|Regorafenib 40 MG|Regorafenib (BAY 73-4506) is an oral small molecule tyrosine kinase inhibitor (TKI) that potently blocks multiple protein kinases, including kinases involved in tumor angiogenesis (vascular endothelial growth factor receptor [VEGFR] 1, 2, 3, Tyrosine kinase with immunoglobulin-like and epidermal growth factor-like domains 2 [TIE2]), stem cell growth factor receptor (KIT, rearranged during transfection [RET], p38-alpha, a member of the mitogen activated protein kinase [MAPK] family, proto-oncogene c-RAF [c-RAF], proto-oncogene BRAF [BRAF], BRAFV600E), metastasis (VEGFR3, platelet-derived growth factor receptor [PDGFR], fibroblast growth factor receptor1 [FGFR1]) and tumor immunity (colony stimulating factor 1 receptor [CSF1R]).
15796978|NCT04476277|Drug|Biotin label|Autologous cells will be collected and biotin-labeled ex vivo and reinfused to measure red cell survival
15796979|NCT04476264|Procedure|Novel use of an adjustable single 8-0 polypropylene suture of scleral fixation without conjunctival dissection|The present study serves to describe a novel approach to utilizing a single adjustable 8-0 polypropylene suture for scleral fixation without conjunctival dissection and to evaluate safety and efficacy outcomes associated with this technique.
15796980|NCT04476251|Biological|E7 TCR|Patients will receive up to 3x10^10 E7 TCR T cells (i.e. TCR+ cells).
15796981|NCT04476238|Dietary Supplement|Inosine|2 grams of inosine dissolved in 250 ml water taken by mouth
15796982|NCT04476238|Other|Placebo|250 ml water taken by mouth
15796983|NCT04476212|Other|Topical antibiotic prophylaxis|The surgical wound will be irrigated with an antibiotic solution, and then we will apply the same solution using gauze for two minutes on the wound
15796984|NCT04476199|Combination Product|Venetoclax and Decitabine|The prognosis of acute myeloid leukemia (AML) patients aged over 60 years is poor and allogeneic stem cell transplantation (allo-SCT) is the only curative option.The association VEN-DEC is a promising combination therapy for AML elderly patients who are fit and eligible for allo-SCT.
15796985|NCT04476186|Drug|Acyclovir|oral syrp
15796986|NCT04476186|Drug|KOH 10 %|solution for local application
15796987|NCT04476173|Drug|Methoxyflurane - Penthrox|ACS patients who received inhaled methoxyflurane as analgesic treatment
15796988|NCT04476173|Drug|Morphine|ACS patients who received intravenous morphine as analgesic treatment
15796989|NCT04476160|Dietary Supplement|Cinnamon|children recipe 3 grams by day of cinnamon
15796990|NCT04476147|Other|Diagnostic Test: CHA2DS2-VASc, HAS-BLED and Fried Scale.|This is an observational study. All the patients evaluate with CHA2DS2-VASc, HAS-BLED and Fried Scale, and observe the incidence of thrombotic events and the influence of frailty on thrombotic events in elderly patients with NVAF.
15796991|NCT04476121|Procedure|PRF application|PRF application into post-operative wound.
15796992|NCT04476121|Drug|Nipas application|Nipas application into post-operative wound.
15796993|NCT04476108|Drug|LY3016859|Administered IV
15796994|NCT04476108|Drug|Placebo|Administered IV
15796995|NCT04476095|Device|Active PBMT|Active PBMT will be applied using a device with 152 emitters (wavelength - 808 nm; dose - 3000 J; treatment time - 600 s), in the low back region.
15796996|NCT04476095|Device|Placebo PBMT|The placebo PBMT will be applied using the same device as that of active PBMT but without any emission of therapeutic dose. Moreover, the irradiated site and the irradiation time were the same as that of active PBMT. Patients received a total dose of 0 J in the placebo mode. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (active or placebo).
15796997|NCT04476082|Other|No intervention - observational study only|No intervention - observational study only
15796998|NCT04476069|Drug|IBUPROFEN|given to children 30 minutes before extraction / orally for one time only
15796999|NCT04476056|Other|Intensified Nutritional Therapy|Intensified nutritional therapy will begin in the hospital setting and comprises intake of a commercial oral nutritional supplement (Fortimel Compact 2.4, Nutricia) twice per day as well as personalized dietary counselling. After discharge, supplementation will be continued for at least 28 days and if necessary throughout the entire study duration. Likewise, dietary counselling will be provided throughout the entire study period based on the patient's individual need. Dietary counselling is provided either face-to-face during the follow-up visits or remotely via telephone between visits.
15797002|NCT04476030|Drug|SAGE-217|Oral capsules
15797003|NCT04476030|Drug|Matching Placebo|Oral capsules
15797004|NCT04476030|Drug|Sertraline|Oral tablets
15797005|NCT04476030|Drug|Escitalopram|Oral tablets
15797006|NCT04476030|Drug|Citalopram|Oral tablets
15797007|NCT04476030|Drug|Duloxetine|Oral capsules
15797008|NCT04476030|Drug|Desvenlafaxine|Oral tablets
15797009|NCT04476017|Drug|SAGE-718|SAGE-718 oral tablets.
15797010|NCT04476004|Other|scapular-focused exercise|scapular-focused exercise
15797011|NCT04476004|Other|visual feedback|EMG visual feedback
15797012|NCT04475991|Drug|Maraviroc + Currently used therapy|"Maraviroc tablets. 300 mg bid, given orally for a 10 day period AND CT (Enoxaparin, dexamethasone, and antibiotics if associated bacteremia is present, as per currently used at Hospital General de México Dr. Eduardo Liceaga)"
15797013|NCT04475991|Procedure|Curently used therapy for COVID-19 non-critical patients|"Enoxaparin, dexamethasone, and antibiotics if associated bacteremia is present, as per currently used at Hospital General de México Dr. Eduardo Liceaga"
15797014|NCT04475991|Drug|Favipiravir + Currently used therapy|"Favipiravir tablets 200 mg. given orally for a 7 day period. 1600 mg bid on day 1 and 600 mg tid days 2-7 AND CT (Enoxaparin, dexamethasone, and antibiotics if associated bacteremia is present, as per currently used at Hospital General de México Dr. Eduardo Liceaga)."
15797015|NCT04475991|Drug|Maraviroc+Favipiravir+CT|"Maraviroc tablets. 300 mg bid, given orally for a 10 day period AND Favipiravir tablets 200 mg. given orally for the first 7 days. 1600 mg bid on day 1 and 600 mg tid days 2-7 AND CT (Enoxaparin, dexamethasone, and antibiotics if associated bacteremia is present, as per currently used at Hospital General de México Dr. Eduardo Liceaga)"
15797016|NCT04475978|Device|IVUS-guide DCB PTCA|IVUS-guide DCB PTCA
15797017|NCT04475978|Device|Angio-guide DCB PTCA|Angio-guide DCB PTCA
15797018|NCT04475965|Other|Isometric exercise for shoulder external rotators|The intervention included the application of a series of isometric contraction for the external rotators shoulder muscles. The exercise protocol included two intensities; high-level isometric contraction (80% maximal voluntary isometric contraction) versus a low-level isometric contraction (20% maximal voluntary isometric contraction).
15797019|NCT04475939|Drug|Niraparib|Niraparib will be administered
15797020|NCT04475939|Drug|Pembrolizumab|Pembrolizumab will be administered
15797021|NCT04475939|Drug|Placebo|Matching placebo will be administered
15797022|NCT04475913|Other|DIG Axial|patients received 4 axial implants and digital impression
15797023|NCT04475913|Other|DIG Tilted|received two anterior axial implants and two distal tilted implants, and digital impression
15797026|NCT04475900|Diagnostic Test|Corneal biomechanics (Corvis ST, Oculus, Wetzlar, Germany)|To measure corneal biomechanics with Scheimpflug based tonometry
15797027|NCT04475900|Diagnostic Test|Corneal topography and tomography (Pentacam, Oculus, Wetzlar, Germany)|To measure corneal topography and tomography with Scheimpflug tomograph
15797028|NCT04475900|Diagnostic Test|Optic nerve head measurement|To measure optic nerve excavation
15797029|NCT04475887|Drug|Iron Carboxymaltose|see above
15797030|NCT04475887|Drug|Placebo|see above
15797031|NCT04475874|Other|supervised stretching exercises|30 to 45-minute supervised active stretching program by a trained physical therapist, three times a week for four weeks starting with a warmup of 5 minutes on a stationary bicycle, half jumping jacks and torso rotations
15797032|NCT04475874|Other|non-supervised active stretching home program|non supervised 30 to 45-minute supervised active stretching program three times a week for four weeks starting with a warmup of 5 minutes on a stationary bicycle, half jumping jacks and torso rotations
15797033|NCT04475861|Dietary Supplement|L-arginine supplements and nutritional supports|The enrolled subjects will then be randomized into two groups. The subjects will receive either L-arginine (the study group) or another amino acid supplement (the control group), with 60 patients in each group. All the food intake of the subjects during the 4 weeks of the study will be recorded and supervised by responsible dietitians.
15797034|NCT04475848|Drug|RO6953958|"Part 1: RO6953958 will be administered in an adaptive manner. The starting dose is planned to be 5 milligrams (mg).
~Part 2: The starting dose is planned to be 45 mg."
15797035|NCT04475848|Drug|Placebo|"Part 1: A placebo will be administered in an adaptive manner. The starting dose is planned to be 5 mg.
~Part 2: The starting dose is planned to be 45 mg."
15797036|NCT04475835|Drug|Bivalirudin|Bivaliruding 0.75 mg/kg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg/kg/h until 4 hours after PCI. A prolonged infusion of 0.2 mg/kg/h for ≤20h could be considered at the operator's discretion. It is recommended that ACT be monitored 5 minutes after the first administration, and if ACT is <225 s (Hemotec method), intravenous injection of 0.30 mg/kg of bivalirudin should be administered.
15797037|NCT04475835|Drug|Heparin|Heparin is dosed at 100 U/kg. ACT is monitored 5 min after the first administration, and if the ACT <225 s (Hemotec method), an intravenous injection of heparin should be administered by need.
15797038|NCT04475822|Behavioral|Intermittent fasting|Intermittent fasting group:During the three-month intervention period, participants were allowed to eat for eight consecutive hours and fast for 16 hours a day.The eating time can be freely chosen in the following two periods: 8:00 -- 16:00;12:00 -- 20:00.No specific restriction shall be made on the type and quantity of food.
15797039|NCT04475822|Behavioral|Low carb diet|Low carb diet:The daily carbohydrate intake of participants in this group was limited to 130g/ D, and the recommended diet was formulated according to the standard and combined with the local eating habits in Xi 'an, and dietary habit education was conducted. Participants could eat according to the recommended diet.
15797040|NCT04475822|Behavioral|Low carbon diet and intermittent fasting group|Low carbon diet and intermittent fasting group:Participants fasted for 16 hours a day and ate for eight consecutive hours on the same diet as the low-carb group.
15797041|NCT04475809|Procedure|group C|laparoscopy will be performed with 14-16 mmHg intra-abdominal pressure. At the end of the procedure routine method for CO2 removal, passive exsufflation, will be used by applying gentle abdominal pressure to evacuate the residual gas through the port site.
15797042|NCT04475809|Procedure|Group L|laparoscopy will be performed with 8-10 mmHg intra-abdominal pressure and routine passive exsufflation will be applied for CO2 removal at the end of the procedure.
15797043|NCT04475809|Procedure|Group LR|the intra-abdominal pressure will be kept at 8-10 mmHg during laparoscopy. At the end of the procedure pulmonary recruitment maneuver (PRM) will be done; which consist of five manual pulmonary inflations at a maximum pressure of 60 cm H2O and the fifth will be held for 5 seconds. During this procedure, the surgeon is instructed to keep the port sleeve valve fully opened to allow the CO2 to escape the abdominal cavity.
15797044|NCT04475809|Procedure|Group LS|the intra-abdominal pressure will be kept at 8-10 mmHg during laparoscopy. At the end of the procedure, intraperitoneal normal saline (IPS) will be infused for removal of the intra-abdominal CO2; in which we fill the upper part of the abdominal cavity evenly and bilaterally with isotonic normal saline (15-20 mL/kg body weight)
15797045|NCT04475796|Procedure|Laparoscopic cholecystectomy|Laparoscopic cholecystectomy performed after ERCP
15797046|NCT04475783|Combination Product|Percutaneous Transluminal Angioplasty (PTA)|PTA with an drug-coated balloon catheter (DCB) in the femoropopliteal artery
15797047|NCT04475770|Other|Real Sustained Natural Apophyseal Glides (SNAGS)|"Manual therapists use treatment modalities that include passive techniques such as mobilization and manipulation. Mobilization with movement (MWM) developed by Mulligan involves applying a sustained transverse glide to the spinous process of a vertebra while actively or passively performing. These techniques have gained the name Sustained Natural Apophyseal Glides (SNAGS) as it is maintained at the pain-free range and follows the plane of the apophyseal joints under treatment."
15797048|NCT04475770|Other|Sham Sustained Natural Apophyseal Glides (SNAGS)|The participants in the Sham SNAGs group will be positioned same as the SNAG group. Mulligan belt will be used, which included the patient's waist and physiotherapist's hip. The physiotherapist will place the hypothenar region of his hand on the spinous processes of the symptomatic lumbar spine levels and waited a few seconds without no glide will be performed. Sham SNAGs practice consisted of 3 sets of 6 repetitions and a 60-second rest period was given between the sets.
15797049|NCT04475744|Drug|G-CSF treatment for Bone marrow derived stem cell Mobilization|Mobilization treatment. On the fifth day, collection will be started.
15797050|NCT04475744|Procedure|Platelet Rich Plasma ovarian injection|Mobilized peripheral blood will be obtained to prepare the PRP for injection. Both ovaries will be injected when proper anatomical access can be assessed.
15797051|NCT04475731|Drug|Ponatinib|"Ponatinib 45 mg/day x 4 weeks x 3 courses.
~+/- chemotherapy:
~vincristine or
~L-VAMP (leucovorin, vincristine, aracytin, methotrexate, prednisone)"
15797052|NCT04475718|Behavioral|Fourth Trimester Mobile Tool|A mobile web-based tool for underserved women in the fourth trimester. The mobile platform teaches self-efficacy, care management, and coping skills to help reduce major health risks and provide tools and resources to maintain mental health.
15797218|NCT04474262|Biological|Albumin|Albumin will be 8g/l of ascitic tap. Standard albumin therapy will continue (40gm/week)
15797053|NCT04475705|Drug|propofol|intravenous propofol using Target Controlled Infusion 'Paedfusor' model 2-5 as the main anaesthetic to achieve Bispectral Index 40-60
15797054|NCT04475705|Drug|sevoflurane|sevoflurane at Minimal Alveolar Concentration 0.7-1.3 as the main anaesthetic to achieve Bispectral Index 40-60.
15797055|NCT04475692|Behavioral|Repetitive, task-specific upper limb practice|A self-directed upper limb intervention (implementing a self-selected dose). This intervention uses an adapted upper limb rehabilitation system to support repetitive upper limb training for stroke survivors.
15797056|NCT04475692|Other|Conventional care|Conventional care is the standard care offered to stroke patients in their respective settings. In this context it is guided by Royal College of Physicians (2016). For the purposes of this work, conventional care encompasses any rehabilitation or support services accessed by participants within the primary or secondary care setting, including private therapy services, charity-led exercise groups etc. Conventional care will not be specified in the context of this work, as it is complex in nature and varies between settings.
15797057|NCT04475679|Device|Adhese Universal DC|Adhese Universal DC, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth surface
15797058|NCT04475679|Device|Adhese Universal|Adhese Universal, a dental adhesive, will be used in conjunction with the luting cement Variolink Esthetic to bond indirect restorations to the tooth
15797059|NCT04475666|Other|Replenish protein group|For patients with Body mass index(BMI) <30, use pre-ICU actual body weight(BW) for the calculation; if unavailable, use weight on ICU admission. For patients with BMI >=30, use adjusted body weight
15797060|NCT04475666|Other|Standard protein group|For patients with BMI <30, use pre-ICU actual BW for the calculation; if unavailable, use weight on ICU admission. For patients with BMI >=30, use adjusted body weight
15797061|NCT04475653|Behavioral|Physical Activity using an Activity Tracker|
15797062|NCT04475640|Procedure|Biospecimen Collection|Undergo collection of blood sample
15797063|NCT04475640|Other|Genetic Testing|Undergo genetic testing
15797064|NCT04475627|Diagnostic Test|Cardiovascular Magnetic Resonance (CMR) imaging at 1.5T|Long and short axis bSSFP cines images, long and short axis tagging images and aortic cine images will be obtained. Participants will be randomised to either have cine or tagging images obtained first.
15797065|NCT04475627|Diagnostic Test|Cardiovascular Magnetic Resonance (CMR) imaging at 3T|Long and short axis bSSFP cines images, long and short axis tagging images and aortic cine images will be obtained. Participants will be randomised to either have cine or tagging images obtained first.
15797066|NCT04475614|Dietary Supplement|BioGaia Prodentis lozenges|oral probiotics
15797067|NCT04475614|Procedure|low level laser treatment with Ga-Al-As laser|low level laser treatment
15797068|NCT04475614|Dietary Supplement|B vitamin injections (Neurobion, Merck, Darmstadt, Germany)|intra muscular vitamin injections
15797069|NCT04475601|Drug|Enzalutamide Pill|The once daily dose will be given only during hospitalization and stop if starting invasive mechanical ventilation or at discharge from hospital
15797070|NCT04475588|Drug|Itolizumab IV infusion|"First dose of 1.6 mg/kg dose iv infusion, , investigator discretion to continue with 1.6 mg/kg dose every 2 weeks or 0.8 mg/kg weekly regimen up to 4 weeks.
~BSC: similar to Arm B"
15797071|NCT04475588|Drug|Best supportive care (BSC)|Best supportive care (BSC) included drugs like antivirals, antibiotics, Hydroxychloroquine, oxygen therapy, LMWH, Steroids, Vitamins and Zinc
15797072|NCT04475575|Device|Aeonose|All participants breathed through the Aeonose for five minutes. This device contains metal-oxide sensors that change in conductivity upon reaction with VOCs in exhaled breath. These conductivity changes are input data for machine-learning and used for pattern recognition. A nose clip was placed on the nose of each participant to avoid entry of non-filtered air in the device. Before measuring, the Aeonose was flushed with room air, guided through a carbon filter as well. During each measurement, a video was displayed to distract the participant and to reduce the chance of hyperventilation. Failed breath tests were excluded from analysis; the reason for failure was documented. Four similar Aeonose devices were used for breath analysis. A full-measurement procedure required sixteen minutes.
15797073|NCT04475562|Device|Aeonose|All participants breathed through the Aeonose for five minutes. This device contains metal-oxide sensors that change in conductivity upon reaction with VOCs in exhaled breath. These conductivity changes are input data for machine-learning and used for pattern recognition. A nose clip was placed on the nose of each participant to avoid entry of non-filtered air in the device. Before measuring, the Aeonose was flushed with room air, guided through a carbon filter as well. During each measurement, a video was displayed to distract the participant and to reduce the chance of hyperventilation. Failed breath tests were excluded from analysis; the reason for failure was documented. Four similar Aeonose devices were used for breath analysis. A full-measurement procedure required sixteen minutes.
15797074|NCT04475549|Drug|IW-6463 Tablets|IW-6463 tablets administered orally (daily)
15797076|NCT04475523|Drug|CI-8993|CI-8993 is a fully human immunoglobulin (Ig) G1κ monoclonal antibody (mAb) against the VISTA ligand
15797077|NCT04475510|Other|Antiplatelet treatment discontinuation|All patients will undergo a clinical evaluation and cerebral MRI at 12 months (before antiplatelet treatment cessation) and at 24 months post-PFO closure.
15797078|NCT04475497|Other|Blood management|Treatment will include PO iron, IV iron, B12 or folate per blood management algorithm.
15797079|NCT04475497|Other|Usual care|Usual care per surgeon preference can include iron by mouth or no iron therapy.
15797080|NCT04475484|Other|Online questionnaire|"Parents will receive a link to an online questionnaire through computing services of Lyon's Academy. They have to give their consent to allow their child to participate in the study. Then, children can complete the online questionnaire.
~The questionnaire starts with few explanations on the context of the study, and ends with psycho-education advices and what to do in the event of psychological distress."
15797081|NCT04475458|Procedure|Ultrasound-guided dorsal penile nerve block|This block is performed by the anesthesiologist, after sedation. With an in-plane approach, the tissues around the dorsal penis nerves are visualized. The needle has to pass through Buck's fascia and there the local anesthetic is released.
15797082|NCT04475445|Other|Ultrasound-guided transforaminal epidural steroid injection|Ultrasound identification of the nerve root, fluoroscopic control of the position and injection of a mixture of 10 mg of dexamethasone and 20 mg of lidocaine.
15797083|NCT04475445|Other|Interlaminar epidural steroid injection|Fluoroscopic location of the epidural space C5C6 or C6C7, injection of a mixture of 10 mg of dexamethasone and 20 mg of lidocaine.
15797086|NCT04475419|Procedure|preformed stainless steel crowns cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)|covering the affected molar with preformed metal crown cemented by glass ionomer luting cement(Ketac Cem, 3M Espe)
15797087|NCT04475406|Other|PICF (Periopaper)|After the plaques and soft attachments around the implants were removed, the implants were isolated using cotton rolls and dried with an air spray. The PICF was collected from the mesio-buccal region of the implant using periopaper strips (Oraflow Inc, NY, USA). Paper strips were placed 1-2 mm inside the peri-implant sulcus and kept for 30 s. Paper strips were placed in sterile Eppendorf tubes containing 200 µL of phosphate-buffered saline (PBS). The tubes were kept at -80°C until the analysis day. Paper strips contaminated with saliva or blood were excluded from the sampling.
15797088|NCT04475406|Other|Subgingival plaque, Gracey curette (Hu-Friedy)|After collecting the PICF, the supragingival plaque was carefully removed using a sterile scaler. Implants were isolated using cotton rolls and dried with an air spray. Subgingival plaque samples were collected from the mesio-buccal region of the implant using a sterile plastic Gracey curette (Hu-Friedy, Switzerland) for 30 s. The samples collected were transferred to sterile Eppendorf tubes containing 200 µL of PBS. The tubes were kept at -80°C until the analysis day.
15797089|NCT04475406|Other|Clinical data, williams probe PCPNU (Hu-Friedy)|"A single calibrated examiner performed all (full-mouth and site-specific) clinical measurements (B.K.), including probing depth (PD), clinical attachment level (CAL), presence of bleeding on probing (BOP), 3-year survival rate (CSR), and bone loss (BL).
~The values of PD and BOP were measured from four sites of each implant (mesial, distal, buccal, and lingual) with a Williams type (Hue Friedy, Switzerland) plastic periodontal probe. The PD was recorded as the distance from the base of the peri-implant to the side of the gum in millimeters. BOP was evaluated according to the presence (+) or absence (-) of bleeding within the first 30 s following the measurement of PD.17 Control panoramic films of all patients were taken, and differences in the marginal bone level between radiography images after implant placement and 3 years later were evaluated. Original films and images taken later were taken with the same angle for standardizaton."
15797090|NCT04475393|Device|Carmat Total Artificial Heart|Heart Replacement Therapy
15797091|NCT04475380|Device|Percutaneous coronary intervention|PCI for treatment of coronary or bypass graft lesions
15797092|NCT04475367|Other|App hypercross group|hypertensive patients using HyperCrossApp
15797093|NCT04475367|Other|without App hypercross group|Interdisciplinary health care
15797094|NCT04475341|Biological|BMS + Bone Marrow Aspirate Concentrate|Both groups of patients are surgically treated with arthroscopic bone marrow stimulation (BMS). The control group will receive BMS alone but with a sham-treatment consisting of a Jamashidi (bone marrow aspiration) needle puncture of the iliac crest. The aspirated bone marrow concentrate will be collected and sent for cell characterisation but will not be inserted in the talar OCD. The intervention group will also receive arthroscopic BMS. From this group, BMAC from the iliac crest will be taken by the same needle puncture. Part of this concentrate will be sent for cell characterisation. Another part will be implanted into the talar OCD.
15797095|NCT04475341|Procedure|BMS alone|Both groups of patients are surgically treated with arthroscopic bone marrow stimulation (BMS). The control group will receive BMS alone but with a sham-treatment consisting of a Jamashidi (bone marrow aspiration) needle puncture of the iliac crest. The aspirated bone marrow concentrate will be collected and sent for cell characterisation but will not be inserted in the talar OCD. The intervention group will also receive arthroscopic BMS. From this group, BMAC from the iliac crest will be taken by the same needle puncture. Part of this concentrate will be sent for cell characterisation. Another part will be implanted into the talar OCD.
15797096|NCT04475328|Drug|AngongNiuhuang pill|This group will receive AngongNiuhuang pill 1pill qd/day for 5-day.
15797097|NCT04475328|Drug|Placebo of AngongNiuhuang pill|This group will receive placebo of AngongNiuhuang pill 1pill qd/day for 5-day.
15797098|NCT04475328|Other|Standard treatment|The other treatments according to guidelines for standard treatment of acute ischemic stroke
15797099|NCT04475315|Device|Papillary Muscle Sling|The sling is made of a Gore-Tex sheet or by using a 4 mm Gore-Tex vascular graft implanted around the base of the papillary muscles and tightened.
15797100|NCT04475315|Procedure|CABG surgery|Standard of care Coronary Artery Bypass Grafting (CABG) surgery will be performed to improve blood flow to the heart by bypassing the narrowed segment of a severely diseased coronary artery
15797101|NCT04475302|Biological|BCG vaccine (Freeze-dried)|single dose of BCG vaccine (Freeze-dried) manufactured by Serum Institute of India, Pune. The composition of BCG vaccine is Live, attenuated BCG (Bacillus Calmette-Guerin Strain). (Each 1 ml contains between 2 x 106 and 8 x 106 Colony Forming Units (C.F.U.) with Diluent: Sodium Chloride Injection I.P.)
15797102|NCT04475276|Drug|Placebo|Lifestyle modification with placebo for 12 weeks
15797103|NCT04475276|Drug|Alphalipoic acid|Lifestyle modification with Alphalipoic acid for 12 weeks
15797104|NCT04475250|Device|Tetragraph (TM) NMT Monitor|TetraGraph is a unique, EMG-based portable device for quantitative (objective) monitoring of neuromuscular function. It is a precise and easy to use tool for monitoring depth of block, ensuring adequate recovery of muscle function, and aiding the clinician to reduce the incidence of residual block.
15797105|NCT04475237|Other|CT-scan evaluation and segmentation|CT-scans will be evaluated (to see if they are included in the research group) and segmented if they are accepted.
15797106|NCT04475224|Drug|KP-100IT|Intrathecal injection of 0.6 mg HGF starting at 72 hours since the injury and repeating weekly 5 times
15797107|NCT04475198|Drug|ST-2427|Investigational drug
15797108|NCT04475198|Drug|Placebo|5% Dextrose Injection
15797109|NCT04475185|Device|MakAir|MakAir artificial ventilator
15797110|NCT04475172|Combination Product|Self-Adhesive Flowable Composite|"Fusio Self-Adhesive Flowable Composite combines the benefits of adhesive and restorative technology into one product . Immediately upon application Fusio conditions, bonds, and seals without the need for an etchant or an adhesive.
~It is based on the bonding technology that uses glycerophosphate dimethacrylate(GPDM)to etch enamel and dentin, and hydroxyethyl methacrylate (HEMA) to enhance wetting and penetration by resin into dentin."
15797111|NCT04475159|Procedure|Pressurized Intraperitoneal Aerosol Chemotherapy (PIPAC)|Pressurized Intraperitoneal Aerosol Chemotherapy will be delivered to the abdominal cavity by means of laparoscopy.
15797112|NCT04475146|Other|video vizualisation|video vizualisation
15797113|NCT04475133|Other|Ultrasound guided percutaneous neuromodulation|It is a technique that consists in the electrical stimulation of peripheral nerve trunks, inserting an acupuncture needle in its path and using it as an electrode to apply electrical current
15797114|NCT04475120|Drug|liposomal lactoferrin|oral and intra-nasal formulation
15797115|NCT04475120|Drug|SOC therapy|oral administration
15797116|NCT04475107|Drug|Pyronaridine-Artesunate|Pyramax
15797117|NCT04475107|Drug|Placebo|Placebo
15797118|NCT04475094|Drug|Rubidium-82|Consented subjects will undergo a rest/regadenoson stress myocardial perfusion PET study.
15797119|NCT04475094|Behavioral|Seattle Angina Questionnaire-7|Consented subjects will complete a SAQ-7.
15797120|NCT04475094|Behavioral|Rose Dyspnea Scale|Consented subjects will complete a RDS.
15797121|NCT04475081|Biological|MMR vaccine|Merck MMR-II vaccine
15797122|NCT04475068|Procedure|Lateral Position (left and right lateral decubitus)|Prior to initiating the protocol, patients will be sedated deeply with sedatives and opioids and paralyzed. Patients will be evaluated in 5 positions sequentially: 1) Supine 2) Left lateral 3) Supine 4) Right lateral 5) Supine. The side with the least ventilation evaluated by EIT will define which side will start the sequence. Each step will last 30 minutes. Aeration measured by Electric Impedance Tomography (EIT) and lung ultrasound, distribution of the lung ventilation and perfusion measured by EIT, ventilator and hemodynamic parameters, esophageal pressure, and blood gas analysis will be recorded at the end of each step. Continuous monitoring of blood pressure, heart rate and saturation of arterial blood (SpO2) will be carried out during all steps of the protocol to assess the tolerance to the procedure.
15797123|NCT04475055|Diagnostic Test|Diagnostisches Interview bei psychischen Störungen (DIPS)|The DIPS is a structured interview which assesses the most frequent psychological disorders. It can be delivered by trained clinicians and takes between 50-120 minutes. Its acceptance with patients is very good.
15797124|NCT04475042|Drug|Dapagliflozin|10mg od
15797125|NCT04475042|Drug|Placebo|Placebo
15797126|NCT04475029|Drug|Methadone|One intravenous administration of methadone (0.15 mg/kg treatment weight (height(cm)-100)) one hour prior to expected extubation.
15797127|NCT04475029|Drug|Morphine|One intravenous administration of morphine (0.15 mg/kg treatment weight (height(cm)-100)) one hour prior to expected extubation.
15797128|NCT04475016|Drug|Albumin-Bound Paclitaxel|260 mg/m² IV over 30 minutes on Day 1
15797129|NCT04475016|Drug|Ifosfamide|1200 mg/m² IV over 2 hours on Days 1-3
15797130|NCT04475016|Drug|Cisplatin|25 mg/m² IV over 2 hours on Days 1-3
15797131|NCT04475016|Drug|Nimotuzumab|400 mg IV on Day 1
15797132|NCT04475016|Drug|Triprilimab|240 mg IV on Day 1
15797133|NCT04475003|Other|Teaching|Teaching session about anaphylaxis
15797134|NCT04474990|Drug|Tradipitant|NK-1 Receptor antagonist
15797135|NCT04474977|Other|Microvascular Decompressive Surgery|Microvascular decompression for hemifacial spasm
15797136|NCT04474964|Radiation|Low dose Craniospinal Irradiation plus Focal Radiotherapy|The intervention arm of the study is to prospectively evaluate disease-related outcomes of low-dose CSI plus focal radiotherapy without concurrent chemotherapy followed by standard 6-cycles of adjuvant systemic chemotherapy in WNT-pathway medulloblastoma.
15797137|NCT04474951|Dietary Supplement|Stinging Nettle|Eligible patients will take 40 drops TID of Fluid Extract of Stinging Nettle for control of anemia.
15797138|NCT04474951|Dietary Supplement|Stinging Nettle|Eligible patients will take 40 drops TID of Fluid Extract of Stinging Nettle for control of fatigue.
15797139|NCT04474951|Dietary Supplement|Peppermint|Eligible patients will take 40 drops TID of Fluid Extract of Peppermint for control of nausea.
15797140|NCT04474938|Drug|Daratumumab|16mg/kg, QW Cycles 1-2 (28 days/cycle), Q2W Cycles 3-6, and Q4W thereafter for up to 1 year
15797141|NCT04474938|Drug|Bortezomib|1.3mg/m2 of subcutaneous bortezomib on days 1, 8, 15 and 22 of a 28-day cycle for 6 cycles
15797142|NCT04474938|Drug|Dexamethasone|20mg of dexamethasone on days 1, 8, 15 and 22 of a 28-day cycle for 6 cycles
15797143|NCT04474925|Procedure|Brain Surgery|Surgery to remove brain metastases
15797144|NCT04474925|Radiation|Stereotactic Radiosurgery|SRS uses many focused radiation beams to treat tumors within the brain
15797145|NCT04474899|Drug|Moxonidine 0.4 MG|Participants will be randomly assigned to receive moxonidine 0.4mg/daily and will later receive the alternate treatment. As the study is double blind neither the participant nor the study personnel will be aware of which treatment is currently being tested to avoid any effect this may have on the results. The two 12-week treatment phases will be separated by a 6-week wash out (drug-free) period.
15797146|NCT04474899|Drug|Amlodipine 5mg|Participants will be randomly assigned to receive amlodipine 5mg and will later receive the alternate treatment. As the study is double blind neither the participant nor the study personnel will be aware of which treatment is currently being tested to avoid any effect this may have on the results. The two 12-week treatment phases will be separated by a 6-week wash out (drug-free) period.
15797148|NCT04474873|Procedure|erector spinae block|we administer 15 cc of 0.5% bupivacaine between the erector spine muscle and the transverse process. The distribution of bupivacain was observed on ultrasound.
15797149|NCT04474860|Diagnostic Test|gene sequencing|Gene fragment analysis, Sanger sequencing method and/or high-throughput whole-genome sequencing will be performed to find the pathogenic gene and mutation site of MH in Chinese population.
15797150|NCT04474847|Drug|Abatacept|Participants randomized to abatacept will receive abatacept 125 mg administered by subcutaneous injection once a week. Participants randomized to either the abatacept or the placebo arm who experience a non-severe disease relapse, non-severe disease worsening, or who have not achieved remission by month 3 will have the option of entering an open-label trial period whereby they would receive open-label abatacept for up to 12 months.
15797181|NCT04474600|Drug|Desflurane|The induction and maintenance of anesthesia was performed by inhalation anesthesia using desflurane. In both groups, remifentanil is continuously infused throughout the surgery.
15797182|NCT04474587|Other|Indirect calorimetry|Measurements of REE by indirect calorimetry
15797151|NCT04474847|Drug|Placebo|Participants randomized to placebo will receive a sterile placebo solution administered by subcutaneous injection once a week. Participants randomized to either the abatacept or the placebo arm who experience a non-severe disease relapse, non-severe disease worsening, or who have not achieved remission by month 3 will have the option of entering an open-label trial period whereby they would receive open-label abatacept for up to 12 months.
15797152|NCT04474834|Genetic|Polygenic Risk Score|A Polygenic Risk Score (PRS) is a blood based genetic test which assesses 300 common breast cancer susceptibility loci (Single Nucleotide Polymorphisms). The PRS has been retrospectively validated and categorizes women into three categories of lifetime risk of developing breast cancer: Low Risk (<15% lifetime risk), Above Average Risk (15 to 40%), and high risk (>40 %).
15797153|NCT04474821|Other|Educational Intervention|Receive educational materials on HPV
15797154|NCT04474821|Other|Survey Administration|Ancillary studies
15797155|NCT04474808|Other|L-Arginin containing foot cream|The participants apply one foot (randomized assignment) with the study cream twice a day (morning and evening) over a period of six weeks.
15797156|NCT04474808|Other|Urea-containing foot cream|The participants apply one foot (randomized assignment) with the control cream twice a day (morning and evening) over a period of six weeks.
15797160|NCT04474782|Diagnostic Test|There is not an intervention|There is not an intervention
15797161|NCT04474769|Other|Educational intervention for preceptors|
15797162|NCT04474756|Device|custom-made adjustable mandibular advancement device|a custom-made mandibular repositioning device (MRD), available under medical prescription for the treatment of adult obstructive sleep apnea (OSA) and snoring. It maintains the mandible in an advanced position along the occlusal plane. This ensures patient comfort and treatment efficacy.
15797163|NCT04474743|Other|No intervention - cross-sectional observational only|No intervention - cross-sectional observational only
15797164|NCT04474730|Device|BMT Physical Activity app|This app sends reminders to patients, collect activity data from Apple Watch, and allow patients to submit symptoms.
15797165|NCT04474730|Other|Watch Only|A locked Apple Watch will be used to collect physical activity data from the Watch Only patients.
15797166|NCT04474717|Diagnostic Test|Breath Condensate Collection|Breath Condensate Collection
15797167|NCT04474717|Diagnostic Test|Real-time PCR|Real-time PCR
15797168|NCT04474717|Diagnostic Test|clinical examination, spirometry|spirometry
15797169|NCT04474717|Diagnostic Test|blood monocyte assay|study of blood monocytes in the laboratory of cell technology
15797170|NCT04474704|Device|Cheetah® non-invasive cardiac monitoring system|Cheetah® non-invasive cardiac monitor system will be used to individually determine the duration of magnesium sulfate postpartum (guided by timing of reduction in Systemic Vascular Resistance (SVR))
15797171|NCT04474704|Other|Standard of care|24 hours of postpartum magnesium sulfate
15797172|NCT04474691|Behavioral|Traditional articulation treatment|Traditional articulation treatment involves providing auditory models and verbal descriptions of correct articulator placement, then cueing repetitive motor practice. Images and diagrams of the vocal tract can be used as visual aids; however, no real-time visual display of articulatory or acoustic information will be made available. Knowledge of performance feedback could describe either the desired articulator placement or the auditory quality of the target sound.
15797173|NCT04474691|Behavioral|Visual-acoustic biofeedback|In visual-acoustic biofeedback treatment, the elements of traditional treatment (auditory models and verbal descriptions of articulator placement) are enhanced with a dynamic display of the speech signal in the form of the real-time LPC (Linear Predictive Coding) spectrum generated by the staRt app. Because correct vs incorrect productions of /r/ contrast acoustically in the frequency of the third formant (F3), participants will be cued to make their real-time LPC spectrum match a visual target characterized by a low F3 frequency. They will be encouraged to attend to the visual display while adjusting the placement of their articulators and observing how those adjustments impact F3. Knowledge of performance feedback will typically involve reference to the location of the third peak or 'bump' on the visual display.
15797174|NCT04474678|Other|"My Logbook! - I know my way around!"|"Special issues/booklets of My Logbook - I know my way around! - Every booklet is based on evidence-based interventions. It illustrates psychosocial and interdisciplinary processes in a standardized way, resulting in a practical guide (My Logbook) to accompany the child throughout all stages of oncological treatment."
15797175|NCT04474665|Device|Reverse shoulder arthroplasty utilizing Blueprint Software|Reverse shoulder arthroplasty utilizing Blueprint Software
15797176|NCT04474652|Other|Single Blood Draw from each participant|Health Professionals will seek informed consent and take a single blood collection from the participant. This will take place during the patient's visit to the breast one stop clinic as part of their routine urgent breast referral pathway.
15797177|NCT04474639|Device|echocardiographic examination|conducting an echocardiographic study according to a standard protocol with the determination of diastolic dysfunction of the left ventricle
15797178|NCT04474626|Drug|Isoquercetin|Oral, 1 time per day, per predetermined dosed per 28 treatment cycle.
15797179|NCT04474613|Diagnostic Test|Liquid biopsy|Liquid biopsy done on a blood draw, taking approximately 7 days
15797180|NCT04474600|Drug|Propofol|The induction and maintenance of anesthesia was performed by total intravenous anesthesia using propofol. In both groups, remifentanil is continuously infused throughout the surgery.
15797183|NCT04474574|Device|Simultaneous recording of nocturnal SpO2|The intervention will consist in performing a simultaneous recording of nocturnal SpO2 and pulse rate for at least 4 hours with 3 different devices.
15797184|NCT04474561|Other|Reduced sulfur diet|A reduced sulfur diet includes reducing foods, food additives (e.g., carrageenan) and beverages high in sulfate/sulfur, limiting sulfur containing supplements, and consuming omega-3 fatty acid supplements to potentially help control overgrowth of sulfur-reducing bacteria in the colon. Omega-3 fatty acid intake for cardiovascular disease prevention should be around 500 mg/d23. After dietary assessment if patients are not meeting their required daily intake of 500 mg/d of Omega-3, the RD will recommend increased fish consumption to 200 g per week or 1 g/d of an Omega-3 supplement. This will ensure the daily recommended intake of 500 mg/d is being met to reduce the chances of a deficiency; however, a therapeutic dose for UC will not be recommended (i.e., > 4 g/d18).
15797185|NCT04474548|Other|Ultrasound use|Ultrasound will be used to determine location of IUD after insertion.
15797186|NCT04474522|Genetic|Non-invasive Preimplantation genetic testing for aneuploidy status|In the intervention group, comprehensive chromosome screening using NGS will be performed according to the recommendations of the company in all SCM samples. Sequence of replacement shall be altered by the NiPGT result after morpholgy.
15797187|NCT04474509|Behavioral|FACT Module Engagement|Focused- Acceptance and Commitment Therapy. Third-wave Cognitive Behavioral Therapy (Psychological intervention)
15797188|NCT04474509|Behavioral|FACT Module Openness|Focused- Acceptance and Commitment Therapy. Third-wave Cognitive Behavioral Therapy (Psychological intervention)
15797189|NCT04474509|Behavioral|FACT Module Awareness|Focused- Acceptance and Commitment Therapy. Third-wave Cognitive Behavioral Therapy (Psychological intervention)
15797190|NCT04474496|Other|Assessing the impact of COVID-19|Surveying Marshallese adults in the U.S. to determine the impact of COVID-19
15797191|NCT04474483|Drug|Melatonin|Melatonin will be administered orally as a 10 mg dose three times a day for 14 days. Size 4 clear vegetable cellulose capsules containing 10 mg melatonin, microcrystalline cellulose, and rice concentrate prepared by Life Extension® will be over-encapsulated in opaque gelatin capsules. Over-encapsulation of melatonin treatments will be done by the research pharmacist and will be mailed to study subjects directly by courier. Melatonin capsules will be stored at room temperature.
15797192|NCT04474483|Other|Placebo (Methylcellulose) capsule|Placebo capsules will be prepared with opaque gelatin capsules, filled using methylcellulose and over-encapsulated to appear identical to interventional drug. Placebo capsules will be given orally in the same regimen as intervention (three times daily for 14 days). Capsules will be prepared by the research pharmacist and will be mailed to study subjects directly by courier. Placebo capsules will be stored at room temperature.
15797193|NCT04474470|Drug|NT219|Dose escalation of NT219 as a single agent in adult subjects with recurrent and/or metastatic solid tumors
15797194|NCT04474470|Drug|NT219 and ERBITUX® - Dose Escalation|Dose escalation of NT219 in combination with standard dose ERBITUX® in adult subjects with recurrent and/or metastatic squamous cell carcinoma of the head and neck and colorectal adenocarcinoma
15797195|NCT04474470|Drug|NT219 and ERBITUX® - Expansion|Expansion cohort of NT219 at its RP2D in combination with standard dose ERBITUX® in adult patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck
15797196|NCT04474457|Drug|Favipiravir|"Turkish patient cohort diagnosed with COVID-19 and previously initiated treatment with Favipiravir."
15797197|NCT04474444|Other|attendance by ambulance crew|hear, attendance, convey
15797198|NCT04474431|Other|Evaluation of VEGF-A levels in patients with septic shock is positively correlated with a positive fluid balance.|Evaluation of VEGF-A levels in patients with septic shock is positively correlated with a positive fluid balance.
15797199|NCT04474405|Drug|Flortaucipir F18|IV injection, 370 MBq (10 mCi), single dose
15797200|NCT04474405|Procedure|Brain PET Scan|positron emission tomography (PET) scan of the brain starting immediately after administration (60 minute dynamic imaging plus 4 frames x 5 minutes at approximately 80 minutes post-dose).
15797201|NCT04474405|Procedure|Whole body PET scan|positron emission tomography (PET) scan of the body from the vertex of the head to the thighs starting immediately following injection and repeated over 6 hours
15797202|NCT04474405|Drug|Florbetapir F 18|IV injection, 370 MBq (10 mCi), single dose
15797203|NCT04474405|Procedure|Brain MRI|Volume-based T1-weighted Magnetic Resonance Imaging (MRI) of the brain
15797204|NCT04474392|Other|N/A (Observational Study)|Observational study, no intervention will be administered.
15797205|NCT04474379|Behavioral|Strategy Training (Time- and Event- Based)|In time-based training, strategic clock-checking behavior is taught by requiring participants to click a button to reveal the virtual time of day. Event-based training involves implementation intention methods.
15797206|NCT04474366|Drug|Ropivacaine 0.2% Injectable Solution|Ropivacaine 0.2% Injectable Solution injected as part of the Pectoralis Nerve Block
15797207|NCT04474366|Other|Saline (0.9%)|Saline injection as sham block in identical fashion as Pectoralis Nerve Block
15797208|NCT04474353|Device|Optune|Noninvasive, portable device which generates tumor treating fields (TTFields) manufactured by Novocure
15797209|NCT04474353|Drug|Gadolinium|Gadolinium contrast medium
15797210|NCT04474353|Drug|Temozolomide|Chemotherapy agent
15797211|NCT04474353|Radiation|Stereotactic radiosurgery (SRS)|Standard of Care: SRS (35 Gy in 5 fractions of 7 Gy), 5-day treatment from Day 2
15797212|NCT04474340|Drug|COVID-19 Convalscent Plasma|The source convalescent plasma is typically collected from individuals who have recovered from COVID-19 which contains antibodies titer against SARS-CoV-2 and is administered to patients with COVID-19. Donor eligibility criteria and qualification are based on American Accredited Blood Banks ( AABB) standards , including questionnaires and relevant transfusion-transmitted infections testing are performed. Furthermore, pathogen inactivation will be performed for each unit, CCP was only collected from individuals who meet all donor eligibility requirements (21 CFR 630.10 and 21 CFR 630.15). Donors must be found positive at a diagnostic test of nasopharyngeal swab at the time of illness and positive serological test for SARS-CoV-2 antibodies after recovery. All donors should have negative HLA antibodies.
15797213|NCT04474327|Drug|Montelukast Sodium|Montelukast sodium (Singulair) will be given at a dose according to body weight. Four mg of the drug will be dissolved in four ml milk and the dose will be given once daily at 9 pm for 10 days.
15797214|NCT04474314|Drug|IMR-687|Oral administration of once daily IMR-687
15797219|NCT04474262|Drug|Midodrine Oral Tablet|Midodrine 7.5 mg to 10 mg TDS (keeping the target MAP above 70 mmHg).
15797220|NCT04474262|Other|Placebo|Placebo
15797221|NCT04474236|Other|thoracic lung ultrasound|Patients will be recruited the day of their hospital admission. All patients will be assessed by thoracic Computed Tomography scan then immediately before/after CT scan, patients will be clinically assessed (Q-SOFA, SpiO2/FiO2) and a lung ultrasound evaluation (mean time of evaluation 7 min +/- 3 min; fully respect of COVID-19 barrier measures) will be performed by an investigator. Patients clinical status and outcomes will be extracted from patient's medical file at day 1 and day 28 from patient's admission by investigators blinded from previously recorded lung ultrasound data.
15797222|NCT04474223|Drug|Dexamethasone|"In mother in whom 2° AVB or AV interval >170 ms has been diagnosed in the fetus:
~Dexamethasone 8 mg po/day for 10 days. Then dexamethasone 4 mg po/ day through 28 weeks 6 days gestational age (GA); then 3 mg/day from 29 wks 0 days to 29 wks 6 days GA; then 2 mg/day until delivery"
15797223|NCT04474223|Drug|IVIG|"In a mother in whom 2° AVB has been diagnosed in the fetus:
~One dose of IVIG [1g/kg of maternal weight (max dose 70 g)] at diagnosis of 2° AVB (within 12 hours of detection by mother via home monitoring and within 6 hours of confirmation by echocardiogram). A fetal AV interval > 170 ms will not be treated with maternal IVIG, only dexamethasone."
15797224|NCT04474210|Drug|JNJ-56136379|Participants will receive JNJ-56136379 tablets orally.
15797225|NCT04474197|Drug|VX-864|Tablets for oral administration.
15797226|NCT04474197|Drug|Placebo|Placebo matched to VX-864 for oral administration.
15797227|NCT04474184|Procedure|Biospecimen Collection|Receive vaginal kit for biospecimen collection
15797228|NCT04474184|Behavioral|Focus Group|Attend focus group
15797229|NCT04474184|Other|Survey Administration|Ancillary studies
15797230|NCT04474171|Behavioral|SCI&U online health coaching program|Online secure videoconferencing health coaching platform with resource library to promote self-management. Maximum number of sessions is 14 over 6 months and covers health related topics to reduce secondary complications
15797231|NCT04474158|Behavioral|Creating Peace|Creating Peace is a 12 session curriculum designed to support youth ages 14-19 in healing from experiences of trauma by restoring social connections, strengthening positive coping strategies that exclude all forms of violence, challenging gender norms that foster violence perpetration, and practicing positive bystander intervention skills to intervene safely with peers' disrespectful and harmful behaviors. Through 12 sessions (3 hours/session) over a 4 to 12 week period, Creating Peace offers gender transformative content combined with youth leadership development. Near program conclusion, youth will offer guidance to law enforcement on interacting with youth in a process of social restoration.
15797232|NCT04474158|Behavioral|Job Readiness|Job Readiness Training uses a group discussion format to learn specific skills to prepare for employment including developing goals, seeking jobs, preparing for interviews, and so forth.
15797233|NCT04474145|Procedure|Comb group|"Patients in the Comb group will receive hydrodilatation of the affected shoulder and subdeltoid bursa injection for 2 times in 2-week interval. Patients also receive mobilization exercise and conventional physical therapy (including physical modalities and stretch exercise), 3 times a week, for 8 weeks.
~The injectates for hydrodilation include 10mg triamcinolone, 2cc 1% xylocaine, and 17cc normal saline for both posterior and anterior shoulder joint injection. 10mg triamcinolone and 2cc 1% xylocaine will also be injected into the subdeltoid bursa of the affected shoulder. All injections will be performed under ultrasound guidance. For shoulder joint injection, ａ21 gauge, 3-inch needle will be used; and a 22 gauge, 1.5 inch needle will be applied for subdeltoid bursa injection."
15797234|NCT04474145|Procedure|PT group|The physiotherapy program includes physical modalities (heat therapy and electric therapy) and therapeutic exercise (stretching, ROM exercise, and strengthening), three times a week, and will be continued for 8 weeks or until total recovery of the symptoms. The stretching exercise program is similar to the stretching exercise described above. For mimicking injection in the Comb group, patients in the PT group will receive 2cc 1% xylocain injection at the posterior deltoid muscle.
15797235|NCT04474132|Device|toxoplasma ICT IgG-IgM BK|a point-of-care device, using blood from finger stick to measure the presence or absence of anti Toxoplasma gondii antibody
15797236|NCT04474119|Drug|KN046|In combine therapy stage, KN046 is 5 milligram per kilogram, every 3 weeks. In maintain stage, KN046 is 5 milligram per kilogram, every 2 weeks.
15797237|NCT04474119|Drug|KN046 placebo|"In combine therapy stage, KN046 placebo is 5 milligram per kilogram, every 3 weeks.
~In maintain stage, KN046 placebo is 5 milligram per kilogram, every 2 weeks."
15797238|NCT04474106|Device|Shock waves|The shockwave generator orthogold 100® generates high-energy acoustic waves that behave much like other sound waves except that they have much greater pressure and energy. As with sound waves, Spark Waves® can easily travel great distance as long as the acoustic impedance stays the same.
15797239|NCT04474106|Device|dummy head|The shockwave generator orthogold 100® will be used in combination with a dummy head, to Refrain shock waves
15797240|NCT04474093|Other|Zirconium-reinforced glass ceramics(ZRGC),Lithium disilicate glass ceramics(LGC), Resin infiltrated glass ceramics(RIGC)|
15797241|NCT04474080|Behavioral|Virtual Peer Support Platform|The intervention program will consist of 8 virtual 30-minute sessions delivered across three months. Sessions will follow a structured format including: check-in, issue identification & context, facilitated discussion, environmental strategies, occupational strategies, experiential component, as well as summary and sign-out. Meetings will finish with a stress relieving activity, to be performed together on the web-based platform. The facilitated discussions will follow important themes including focus on self, patients, and external stressors.
15797242|NCT04474080|Behavioral|Control Period|The control period will be the time prior to randomization and commencement of the intervention, whereby residents will receive a 30 minute break each week during their academic half-day.
15797243|NCT04474067|Other|No intervention|This is an observational study, with no intervention.
15797244|NCT04474041|Device|EyeQue Insight|The Insight will be used to measure visual acuity and compared with a standard ETDRS eye chart.
15797245|NCT04474015|Device|transcranial electric stimulation|NeuroConn® DC Plus stimulator: the NeuroConn® stimulator can be programmed with specific frequencies of stimulation ranging from 0.5 to 500 Hz. This device is therefore appropriate for the present study to stimulate only at 0.75 or 3.0 Hz. Also, the NeuroConn only allows low current intensities to be chosen. The maximum current intensity that can be delivered with this stimulator is 5 milliamps.
15797248|NCT04473989|Drug|recombinant teriparatide for injection|weekly subcutaneous administration of 40 ug
15797249|NCT04473989|Drug|Placebo|weekly subcutaneous administration of 40 ug
15797250|NCT04473963|Device|Ablamap Software|Subjects will receive cardiac ablation guided by the Ablamap software. The software will identify atrial fibrillation sources to help guide ablation therapy in patients with persistent atrial fibrillation. Subjects will undergo a cardioversion post ablation, as necessary.
15797251|NCT04473950|Drug|Naloxone Hydrochloride|An intramuscular (IM) injection of naloxone will be given.
15797252|NCT04473950|Drug|Placebo|An IM injection of 0.9% normal saline will be given.
15797253|NCT04473937|Radiation|Radiotherapy|Radiotherapy at pre-determined dose and schedule
15797254|NCT04473924|Drug|Mycophenolate Mofetil|Body surface area-based dosing of mycophenolate
15797255|NCT04473924|Drug|Mycophenolate Mofetil|Standard (fixed) dosing of mycophenolate
15797256|NCT04473911|Drug|FLUDARABINE|predetermined dose, intravenously, a predetermined times per cycle Given in both pre stem cell and post stem cell cycles
15797257|NCT04473911|Drug|CYCLOPHOSPHAMIDE|◦Cyclophosphamide predetermined dose, predetermined number of times in Given in pre-stem cell Regimen #1 Cyclophosphamide predetermined dose, predetermined number of times in cycle, intravenous infusion
15797258|NCT04473911|Radiation|TBI|Total body irradiation (TBI) once per cycle.
15797259|NCT04473911|Drug|Melphalan|Melphalan, infusion, determined dosage, once per cycle
15797260|NCT04473911|Drug|Sirolimus|Sirolimus: Predetermined dosage, predetermined number of time in cycle, oral: Please note that doses of sirolimus can be adjusted at the treating physician's discretion given the multiple drugs and other situations which affect its metabolism
15797261|NCT04473911|Drug|Mycophenolate mofetil|◦Mycophenolate mofetil, oral or iv(predetermined dose or IV TID (based upon actual body weight), at predetermined times per cycle
15797262|NCT04473911|Drug|RGI-2001|IV, predetermined dose, weekly to 6 total doses
15797263|NCT04473911|Drug|CYCLOPHOSPHAMIDE|◦Given in Post Stem Cell cycle of Regimen #1 and #2 Cyclophosphamide predetermined dose, predetermined number of times in cycle, intravenous infusion
15797264|NCT04473898|Other|Aerobic Exercise Training|Aerobic exercises using all body muscles and that one can do on their own after being shown online
15797265|NCT04473898|Behavioral|Patient Education|Patient education about covid-19 and hygiene education
15797266|NCT04473898|Other|Respiratory Exercise Training|Respiratory exercises that one can do on their own after being shown online
15797267|NCT04473885|Other|Perturbation-based balance training|Participants in the experimental group will receive the balance training under perturbation on Balance SystemTM SD, including limits of stability training, maze control training, random control training. The intervention is 40 min/session, 3 sessions/week for 6 weeks.
15797268|NCT04473872|Other|respiratory rehabilitation|intervention includes respiratory muscle strengthening with diaphragmatic respiration and IMT device, in addition to neurodevelopmental rehabilitation.
15797269|NCT04473859|Drug|FSR Peptide 20μM|Administered immediately after punch-biopsy and 24 hours after punch biopsy.
15797270|NCT04473859|Drug|FSR Peptide 50μM|Administered immediately after punch-biopsy and 24 hours after punch biopsy.
15797271|NCT04473859|Drug|FSR Peptide 100μM|Administered immediately after punch-biopsy and 24 hours after punch biopsy.
15797272|NCT04473859|Drug|FSR Peptide 200μM|Administered immediately after punch-biopsy and 24 hours after punch biopsy.
15797273|NCT04473859|Drug|Placebo|Administered immediately after punch-biopsy and 24 hours after punch biopsy.
15797274|NCT04473846|Drug|PK general anesthesia|Patients will be anesthetized using Fentanyl (2 mcg/kg) and Propofol (1-2 mg/kg).
15797275|NCT04473846|Drug|PFK combination|Each patient received an initial dose of 0.05 ml/kg from the solution, then after waiting for 60 seconds, another 0.05 ml/kg were given. Maintenance was given as boluses of 0.025 ml/kg every three to five minutes.
15797276|NCT04473833|Procedure|Serial Transvaginal Ultrasonography|Participants will undergo transvaginal ultrasonography (TVS) to detect ovarian cancer as part of the Kentucky Ovarian Cancer Screening Program. Those with normal findings will repeat the TVS in one year. Those with abnormal results will repeat the screening in 4-6 weeks.
15797277|NCT04473820|Drug|Vapocoolant spray|The spray will be applied continuously from 25 cm distance for less than 5 seconds to the cannulation site.
15797278|NCT04473820|Drug|Lidocaine-Prilocaine cream|A finger tip (0.5 gr) of the cream will be applied in 4 square cm at cannulation site and will be covered with closed dressing for 45 minutes.
15797279|NCT04473807|Drug|Intravenous Sotalol Administered as a Loading Dose to Initiate Oral Sotalol Therapy in Adult Patients with Atrial Fibrillation|The hypothesis to be tested is that the intravenous loading regimen followed by oral sotalol administration 4 hours after the conclusion of the IV infusion (every 12 hours thereafter) will result in sotalol peak concentrations at the end of IV loading dose (IV to oral loading) which are comparable to the steady state and maximum QTc seen on Day 3 after the last in-hospital oral dose.
15797280|NCT04473781|Procedure|Interstitial Radiation Therapy|Undergo interstitial brachytherapy
15797281|NCT04473742|Biological|Blood collection|4 EDTA tubes for 24 mL blood collection
15797282|NCT04473742|Biological|Blood sample|2 drying tubes for 12 mL blood collection
15797283|NCT04473742|Biological|Blood sample|1 drying tube for 6 mL blood collection
15797284|NCT04473729|Other|Audiovisual speech training in noise for children|Children will participate in listening training in the form of an iPad app
15797285|NCT04473716|Drug|Toripalimab|Inductive therapy with Toripalimab of 240mg, iv, qd, on day 1, 22
15797286|NCT04473716|Drug|Paclitaxcel|Inductive therapy with Paclitaxcel of 260mg/m2, iv, qd, on day 1, 22
15797288|NCT04473716|Procedure|Radical surgery|Radical surgery will be performed on the 43th-48th after initiation of inductive therapy.
15797289|NCT04473716|Radiation|Post-operative radiotherapy/chemoradiotherapy|Post-operative radiotherapy/chemoradiotherapy will be performed within 1.5 months after radical surgery, depending on the post-operative pathological diagnosis.
15797290|NCT04473703|Drug|renin-angiotensin system inhibitors or angiotensin-receptor-neprilysin inhibitor|Patients with odd random number will treat with RASI（renin-angiotensin system inhibitors）, and those with even random number will treat with ARNI（angiotensin-receptor-neprilysin inhibitor）
15797291|NCT04473690|Biological|Low Dose of KBP-COVID-19|Low Dose of KBP-COVID-19 and adjuvant
15797292|NCT04473690|Biological|High Dose of KBP-COVID-19|High Dose of KBP-COVID-19 and adjuvant
15797293|NCT04473690|Biological|Placebo|Buffered saline solution
15797294|NCT04473677|Diagnostic Test|The new qFIT and colonoscopy with pathological examination|Detect hemoglobin in stool by the new qFIT before colonoscopy, detect colon lesion using colonoscopy and pathological examination.
15797295|NCT04473664|Drug|Quizartinib|Single dose of 30 mg quizartinib to be administered orally
15797296|NCT04473651|Drug|Lu AG06479|capsules, orally (Part A and B)
15797297|NCT04473651|Drug|Placebos|Placebo - capsules, orally (Part A only)
15797298|NCT04473638|Procedure|Arthroscopic Deltoid Repair|. A 4.5 mm arthroscopic set was used to clean the joint and assess medial and associated injuries. After deltoid injury confirmation through the method already mentioned, the medial gutter was prepared. The ideal positioning for the bone anchor in the medial malleolus followed Vega's recommendations and was located in the inferolateral quadrant created by the intersection of two lines: (1) tibia-talar joint line and (2) tangent line to the medial malleolus joint surface.(14). Sutures were passed respecting the safe zone illustrated by Acevedo at al, at the area between the posterior tibial tendon and the saphenous vein (16-25mm) (15). Sutures were passed but not tightened.
15797299|NCT04473625|Other|Stool Sample Collection|Subjects participating in the study will provide a stool sample within 30 days of enrollment.
15797300|NCT04473599|Behavioral|Uniform random message delivery|In this arm, the categories and timings of text-messages will be delivered to participants using a random schedule
15797301|NCT04473599|Behavioral|Reinforcement learning message delivery|In this arm, the categories and timings of text-messages will be chosen by a reinforcement learning algorithm
15797302|NCT04473586|Device|Spartan Cube CYP2C19 System|Using buccal material, determine the genotype of the *2, *3 and *17 SNPs of the CYP2C19 gene on the Spartan Cube CYP2C19 System.
15797303|NCT04473573|Device|Spartan Cube CYP2C19 System|Using buccal material, determine the genotype of the *2, *3 and *17 SNPs of the CYP2C19 gene on the Spartan Cube CYP2C19 System.
15797304|NCT04473560|Device|Catheter-directed thrombectomy|Using common femoral venous access the pigtail diagnostic catheter will be placed into the main pulmonary artery and an initial pulmonary angiogram will be performed to demonstrate the location and extent of thrombi in pulmonary arteries. Then pulmonary arterial pressures will be measured. Subsequently an Indigo catheter (Penumbra, Alameda, California) will be placed and a direct-aspiration first-pass technique will be performed purposefully to attach a large thrombus to the catheter tip by suction and then pull it out through the sheath. The decision to terminate the intervention will be at operator's discretion after careful evaluation of hemodynamic parameters (restoration of the systolic blood pressure≥100 mmHg, heart rate <100/min), improvement of arterial blood saturation≥ 92%, practicable clot burden reduction and total amount of aspirated blood (no more than 300 ml).
15797305|NCT04473534|Behavioral|web based cognitive-behavioral therapy|one web session of psycho-education about sleep
15797306|NCT04473521|Device|Investigational denture adhesive cream|The denture adhesive application will be controlled by weight (1.00g +/-0.05g) applied to the maxillary denture only.
15797307|NCT04473521|Device|Super Poligrip Free|The denture adhesive application will be controlled by weight (1.00g +/- 0.05g) applied to the maxillary denture only.
15797308|NCT04473508|Drug|Local administration of ropivacaine|Erector nerve block with local ropivacaine injection in addition with conventional anesthesia for spine surgery
15797309|NCT04473508|Drug|Local administration of placebo (saline solution)|injection of saline solution in addition with conventional anesthesia for spine surgery
15797310|NCT04473495|Device|educational video|educational video before intervention
15797311|NCT04473482|Behavioral|Michigan Alcohol Improvement Network-Alcohol Reduction and Treatment tool|The intervention corrects misconceptions about alcohol use, liver disease, and alcohol treatment and matches patients to their top three choices of treatment while providing them with brief explanations of each treatment option.
15797312|NCT04473469|Device|Medtronic Interstim II Model 3058 Neurostimulator|Patients will undergo stimulation of the pudendal nerve. All stimulation parameters used will be within the normal hard-coded limits of the implantable pulse generator (IPG).
15797313|NCT04473456|Procedure|Simultaneous EGD and colonoscopy|Patients are examined simultaneously by EGD and colonoscopy
15797314|NCT04473443|Other|FEops HEARTguideTM|A patient-specific computer simulation that aims to improve the outcomes after TAVI by suggesting THV platform, THV size and implantation depth with the use of the pre-procedural CT-scan.
15797315|NCT04473430|Device|Dexcom G6 CGM|"Dexcom G6, a factory-calibrated CGM system, is innovative in many aspects: 1) it does not require finger stick POC BG for calibration, 2) the sensor is small, compact, light-weight, 3) has no interference with several substance and drugs, and 4) protective urgent low soon alarm, with proven prediction of hypoglycemia within 20 minutes in advance. The sensor uses a novel semi-permeable membrane that blocks interference with most clinically relevant substances, including high levels of urea and creatinine, and commonly used medications. Dexcom G6 CGM is a commercially-available, minimally invasive sensor, with a flexible and thin wire that is inserted into the abdominal subcutaneous tissue."
15797316|NCT04473430|Diagnostic Test|POC BG|POC BG (standard of care) uses commercially-available glucose meters, approved to be used in dialysis populations.
15797317|NCT04473417|Drug|Forxiga|single dose administration after 10hr fasting
15797318|NCT04473417|Drug|DA-2811|single dose administration after 10hr fasting
15797319|NCT04473417|Drug|DA-2811|single dose administration after 10hr fasting
15797320|NCT04473417|Drug|DA-2811|single dose administration after high fat and calorie fed diet
15797368|NCT04472949|Drug|carboplatin|Carboplatin: AUC 5 mg/mL/min iv
15797369|NCT04472949|Drug|etoposide|Etoposide: 100 mg/m2 iv
15797321|NCT04473404|Dietary Supplement|Streptococcus salivarius DB-B5 - 2 billion CFU/day|The participants (n=15) will consume sachets containing Streptococcus salivarius DB-B5 (at 1 billion CFU/sachet) dissolved in water twice daily for 4 weeks.
15797322|NCT04473404|Dietary Supplement|Streptococcus salivarius DB-B5 - 10 billion CFU/day|The participants (n=15) will consume sachets containing Streptococcus salivarius DB-B5 (at 5 billion CFU/sachet) dissolved in water twice daily for 4 weeks.
15797323|NCT04473404|Other|Placebo|The participants (n=15) will consume sachets containing a placebo (probiotic carrier) twice daily for 4 weeks.
15797324|NCT04473391|Device|Cycle-ergometer training assisted by FES for lower extremities|The intervention consists of FES treatment sessions on a cycle ergometer for the lower extremities. Each subject received 24 sessions lasting 45 minutes each and a frequency of 3 sessions per week. The sessions will be applied by a physiotherapist with experience in electrotherapy. A 6-channel FES device (TrainFES, Biomedical Devices SpA, Chile) will be used, which consists of a stimulator unit of 95x50x30mm and 100g of weight coupled to the motorized cycle ergometer (MOTOmed Viva 2, Reck GmbH., Germany), a remote user interface consisting of an android application for the configuration of the stimulation via Bluetooth 3.1, and an inertial measurement unit positioned on the rotation axis of the cycle ergometer to detect the rotations and trigger the synchronized electrical stimulation according to the stimulation pattern pre-configured for the pedaling exercise
15797325|NCT04473378|Device|FreeStyle Libre Pro|The device uses patches that attach to the skin on the back of the arm to measure blood sugar changes for the duration of the chemotherapy course.
15797326|NCT04473365|Other|Intestinal parasite|Pre-existing intestinal parasite infection present or absent at time of admission
15797327|NCT04473339|Procedure|CRS+HIPEC|"Patients will undergo only CRS, HIPEC and IVCT.Patients will receive standard platinum-based combination doublet chemotherapy for 6-8 cycles after CRS and then followed by maintenance therapy.
~A single drug lobaplatin(30mg/m2)will be administered in normal saline via HIPEC and it will be continued for 60 minutes in the hyperthermic phase (41°C-43°C). HIPEC will be performed at the 1st, 3rd and 5th day after CRS. The intravenous chemotherapy(IVCT) will start from 7th-14th day after CRS."
15797328|NCT04473339|Procedure|CRS alone|Patients will undergo only CRS and IVCT.Patients will receive standard platinum-based combination doublet chemotherapy for 6-8 cycles after CRS and then followed by maintenance therapy.
15797329|NCT04473326|Behavioral|Reinforcement Learning|Participants in the intervention arm will receive up to daily, tailored text messages based on their electronic pill bottle-measured adherence. Given the participants' baseline characteristics and time-varying responses to the messages, a reinforcement learning algorithm will deliver different text messages and adapt over time to determine which type of messaging works best for each individual participant.
15797330|NCT04473287|Other|reflexology practice|Reflexology is a reliable and holistic complementary and alternative treatment method that means that the body's specific glands, organs and regions are stimulated by applying a special pressure with the fingers on the hands, feet and ears. When the literature is analyzed, it has been determined that reflexology is applied effectively before, during and after surgery, including different surgical procedures, and it is emphasized that one of the most important areas is patients who underwent Coronary Artery Bypass Graft (CABG) surgery. In this study, it is thought that reflexology application to patients undergoing CABG surgery on nursing care will contribute to the nursing literature by examining the effect of reflexology on pain, anxiety, fatigue, sleep and physiological parameters.
15797331|NCT04473274|Drug|Pioglitazone|Receive pioglitazone 15mg - 30mg daily
15797332|NCT04473261|Drug|Iodine Complex|Iodine Complex capsule (200mg) will be given three times a day
15797333|NCT04473261|Drug|Iodine Complex|Iodine Complex syrup form (40ml) will be given three times a day
15797334|NCT04473261|Drug|Placebo|Empty capsule will be given as placebo
15797335|NCT04473261|Drug|Idoine Complex|Iodine Complex spray form 2 puffs will be given three times a day
15797336|NCT04473248|Device|Spartan COVID-19 System|PCR analysis of patient samples using the Spartan COVID-19 System
15797337|NCT04473235|Behavioral|Literacy training|Teaching adults how to read and write using the analytical and phonemic method
15797338|NCT04473235|Behavioral|Non-Literacy training|Attending classes in geography, history, sciences, without receiving the specific training in literacy
15797339|NCT04473222|Behavioral|Sleep Well!|Sleep Well! is a brief, behavioral sleep intervention. The intervention was originally comprised of healthy sleep advice and tested in the context of a sleep health education campaign for impoverished children. Based on preliminary research regarding the need for sleep intervention in primary care, Investigators have expanded the intervention to more comprehensively address poor sleep health behaviors (e.g., use of electronics at bedtime; inconsistent and variable sleep schedules; lack of a bedtime routine) as well as insomnia (difficulty falling and staying asleep; the need for caregiver presence at bedtime) and insufficient sleep in toddlers and preschoolers who are living in disadvantaged contexts. Intervention components are based on effective pediatric behavioral sleep treatments.
15797340|NCT04473222|Behavioral|Sleep education|Sleep education for caregivers of toddlers and preschoolers is provided via a Parent Family Education handout available to families and clinicians in the CHOP primary care network. The handout contains evidence-based advice about healthy sleep in early childhood.
15797341|NCT04473209|Procedure|non-surgical periodontal therapy|supra and subgingival debridement
15797342|NCT04473196|Other|weightbearing|immediate weightbearing
15797343|NCT04473183|Diagnostic Test|Specimen Collection|"Blood: Two tubes of blood (up to 10 ml each) will be drawn from participants and will be collected by experienced phlebotomists.
~Nasal, oral, and rectal swabs: Nasal, oral, and rectal swabs are optional specimens that patients may be asked to donate. If prospective consent is provided, swabs will be self-collected by participants after receiving clear instructions from the team and collected in the dedicated container.
~Saliva: Saliva is an optional specimen that patients may be asked to donate. If prospective consent is provided, whole saliva samples will be self-collected by participants using a pad placed between the cheek and gum for 2-5 minutes or collecting the saliva directly to a sterile container."
15797344|NCT04473183|Diagnostic Test|Surveys|Participants will be asked to fill out a brief online survey that will investigate symptoms consistent with SARS-CoV-2 infection in the past 3 months and the geographic location of the clinic(s) they work in (if a resident of a medical school) and their comorbidities related to SARS-CoV-2.
15797393|NCT04472806|Drug|chemotherapy in combination with Endostar|chemotherapy+ Endostar
15797345|NCT04473170|Biological|Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC)|SENTAD-COVID Study intervention consists of Autologous Non-Hematopoietic Peripheral Blood Stem Cells (NHPBSC) therapy through jet nebulization in addition to standard care. The NHPBSC were characterized as CD90+, CD133+, Oct-4+ (pluripotent markers), and CD45-, CD71-, based on multiparameter flow cytometry.
15797346|NCT04473170|Drug|COVID-19 standard care|UAE National Guidelines for Clinical Management and Treatment of COVID-19.
15797347|NCT04473144|Drug|Ulinastatin|In the Ulistine administration group, 300,000 KIU was mixed with 100 mL physiological saline and administered over 15 minutes after induction of anesthesia.
15797348|NCT04473131|Other|No intervention|Only blood samples will be taken from participants for this study
15797349|NCT04473118|Other|Survey|An online-based questionnaire sent to participants via email
15797350|NCT04473092|Device|TMVR|Patients who undergo TMVR for MR at the PI´s site
15797351|NCT04473079|Dietary Supplement|Lacidofil|Investigational product intake daily for 6 weeks. Co-administration of H. pylori treatment with investigational product the first two weeks only.
15797352|NCT04473079|Dietary Supplement|Placebo|Investigational product intake daily for 6 weeks. Co-administration of H. pylori treatment with investigational product the first two weeks only.
15797353|NCT04473066|Procedure|Adenotonsillectomoy +/- turbinate reduction|Tonsillectomies were performed by bipolar electrocautery while adenoidectomies were done by monopolar suction diathermy. Turbinate reduction (by either submucosal bipolar diathermy or radiofrequency) would be offered if the subject had on-going history of allergic rhinitis and examination revealed at least grade II turbinate hypertrophy. (Grade I = no turbinate hypertrophy; Grade II = turbinate hypertrophy without touching the septum; Grade III = turbinate hypertrophy touching the septum).
15797354|NCT04473053|Drug|Nafamostat Mesilate|Nafamostat has been shown to have potential antiviral effects against MERS CoV and is thought to possibly inhibit SARS CoV2 infection via inhibition of viral entry due to inhibition of TMPRSS2. In addition, nafamostat has potent anticoagulant properties which may provide benefit in patients with DIC, a common finding in serious cases of COVID-19. Nafamostat has been broadly well tolerated in clinical trials in patients with DIC and acute pancreatitis.
15797355|NCT04473053|Drug|TD139|TD139 is a specific inhibitor of galectin-3 which has been investigated in healthy volunteers and patients with IPF. No serious drug related serious adverse events have been reported to date. TD139 had no impact on cardiac, haematological or biochemical measures of safety during trials in humans to date. Beneficial effects on biomarker measures of lung inflammation were observed in patients with IPF. It is the purpose of this investigation to examine the potential for delivery of this inhibitor in pre-ventilator patients hospitalised with COVID-19 to examine whether this may lead to detectable changes in blood biomarkers, reduce viral load and also reduce disease severity such as time to ventilation.
15797356|NCT04473053|Other|Standard care|Patients will receive standard care.
15797357|NCT04473040|Drug|alpelisib|Alpelisib is provided as 50 mg and 200 mg film coated tablets as individual patient supply, packaged in bottles. Alpelisib will be dosed on a flat scale of mg/day and not be adjusted to body weight or body surface area. Alpelisib will be administered at a starting dose of 300 mg orally once daily on a continuous dosing schedule and can be adjusted for toxicity per the recommendations in this treatment plan.
15797358|NCT04473027|Diagnostic Test|Blood sample collection|Whole venous blood of participants will be collected in EDTA tubes (max. 10 mL) at baseline, before start of first immunotherapy round. The Belgian Red Cross will perform serological blood group diagnostics, and molecular RBC typing.
15797359|NCT04473014|Behavioral|Heat Pain Paradigm|A standardized heat pain paradigm will be applied. Pain threshold will be determined with the self-controlled search method starting at 32°C, with a mouse-click-induced increase of 0.1°C per click. Pain tolerance is defined as the time in seconds elapsed from the onset of the pain stimulus to a participant's withdrawal from the stimulus. Participants will be instructed to continue with the task for as long as they can and to press a button if it becomes too uncomfortable or painful. Temperature will then return to baseline. To avoid physical injury, the measurement will stop automatically at a maximum temperature of 50°C.
15797360|NCT04473001|Other|Continuous vital signs and glucose monitoring|"The patients will have the following parameters and vital signs continuously monitored using wireless equipment:
~Glucose measurements (quasi-continuous, every 5 minutes)
~Heart rate
~Heart rhythm (single-lead ECG; quasi-continuous, 10 seconds every minute)
~Signs of cardiac ischemia (single-lead ECG; quasi-continuous, 10 seconds every minute)
~Respiration rate
~Oxygen saturation of arterial hemoglobin (%SpO2)
~Perfusion index (ratio of the pulsatile blood flow to the non-pulsatile or static blood in peripheral tissue)
~Blood pressure (quasi-continuous; every 30-60 minutes)
~Skin temperature
~Electrodermal activity
~Ambulatory activity (accelerometry)"
15797361|NCT04472988|Behavioral|Eye Movement Desensitization and Reprocessing|"The first session will be assigned to the assessment and the exploration of the personal history and for presenting the method to the client. Then, each case will be conceptualized according to the Model of Two Method Approach and the protocol for the treatment will be used. The procedure will be organized around targeting the most ten disturbing memories which happened before the illness debut, including stressful or traumatic memories from childhood. The rationale behind this approach is that adverse events leave traces in the neural network of an individual in such a way that these cause a variety of emotional or cognitive symptoms. If we consider the illness as being also a symptom of a traumatic past, then we expect that by accessing the dysfunctionally stored memory and stimulating the innate processing system, the symptoms of the illness diminish."
15797362|NCT04472988|Other|Placebo|The participants randomised in this group will receive a protocol focused only on present and future (present symptoms, daily problems, future projects). The psychologist will lead the discussion anywhere except for the past.
15797363|NCT04472988|Drug|Treatment as Usual|The participants randomised in this group will continue taking the classical treatment prescribed for Hashimoto (Levothyroxine)
15797364|NCT04472975|Drug|Exposure to one or more disease-modifying drug(s)(DMDs) used to treat MS|Individuals with MS exposed to one or more DMDs (beta-interferon, glatiramer acetate, natalizumab, fingolimod, dimethyl fumarate, teriflunomide, alemtuzumab, daclizumab or ocrelizumab; regardless of dose, frequency or duration of treatment) between 1st January 1996 and 31st March 2018 in five Canadian provinces.
15797365|NCT04472962|Other|Pre-exercise meal|Mixed meal with low-carbohydrate-high-protein content
15797366|NCT04472962|Other|Pre-exercise meal|Mixed meal with high-carbohydrate-low-protein content
15797370|NCT04472949|Radiation|Thoracic radiotherapy|Thoracic radiotherapy: 39 Gy in 13 fractions, starting 3-8 weeks after day 1 of last cycle of induction treatment, over 2.5 weeks Prophylactic cranial irradiation (PCI) is allowed but optional: according to local practice, starting 3-8 weeks after day 1 of last cycle of induction treatment Follow up phase Patients will be followed up for 24 months, every 8 weeks.
15797371|NCT04472936|Procedure|Single catheter approach|Single venous femoral access will be obtained and the ablation will be performed similar to Group A. After the ablation line is over, we will confirm CTI block using the PRI. During atrial pacing (10 V, 1.5 ms) at a stable cycle length (range 500-700ms) from the tip of the ablation catheter with a sweep speed of 300mm/s, the ablation catheter will be placed first at 5 o'clock (medial to CTI line), then at 7 o'clock (lateral to CTI line), and finally at 9 o'clock position, and the corresponding PRIs will be measured for each pacing site. CTI block is assumed when: (i) the PRI at 7 o'clock is >80ms longer than that at pacing sites of 5, and (ii) the PRI at 9 o'clock is shorter than the PRI at 7 o'clock.
15797372|NCT04472936|Procedure|Traditional approach|Double venous femoral access will be obtained. A duodecapolar catheter will be positioned in the right atrium around the tricuspid valve annulus (TVA) to record activation sequence around the tricuspid annulus. An ablation catheter will be positioned using fluoroscopic guidance in the central CTI, 6 o'clock in a left anterior oblique view. The distal ablation electrode position will then be adjusted toward or away from the TVA, based on the ratio of atrial and ventricular electrogram amplitudes with an optimal ratio of 1:2 or 1:4 at the TVA. After the ablation catheter is positioned, it will be very slowly withdrawn during ablation toward the inferior vena cava while radiofrequency energy is applied continuously. CTI block will be evaluated after ablation by determining the right atrial activation sequence during pacing from the low lateral right atrium and coronary sinus ostium.
15797373|NCT04472923|Procedure|Traditional Treatment|"Patients belonging to the control group received conventional physical therapy program in the form of:
~Dietetic Regulation: The diet was given in the form of the bulk-forming diet, fruits, vegetables, cereals, and bran.
~Pelvic floor muscle exercises (Kegal exercises): The patient was instructed to lie crock lying position with knees bent. He/she was instructed to pull his/her pelvic muscles upward and inward and hold the contraction for 6 seconds as if to hold back a defecation movement, followed by relaxation for 6 seconds. The exercise was repeated 25 times. Gradually increase the time until reaching 10 seconds of contraction and relaxation for each with repetition up to 30 times. The exercises applied twice per week for 3 months."
15797374|NCT04472923|Device|Biofeedback|"Patients belonging to the study group were subjected to the same conventional physical therapy program in addition to biofeedback training.
~Biofeedback was planned after full guardians' education. Local hygiene for perianal skin for soiling episodes and using zinc oxide cream to prevent excoriation. Biofeedback was done using two types of catheters; a 24-channel water-perfused catheter with latex balloon for sensory training and a double-lumen rectal PVC balloon clothed catheter (MMS U-72210) for strength training. Each biofeedback session took 30 minutes with two sessions per week for 3 months."
15797375|NCT04472910|Drug|Modified Folforinox (mFFX)|Neo-adjuvant mFFX for up to 6 cycles, chemo-Adjuvant FFX q 2 weekly or other approach as per investigator to complete up to 6 months chemotherapy
15797376|NCT04472897|Drug|GSK2556286|GSK2556286 is a tablet available in 25 mg, 75 mg and 250 mg dosing strength. It will be given via oral route.
15797377|NCT04472897|Drug|Placebo|Placebo tablet matching to the study treatment will be given via oral route.
15797378|NCT04472884|Behavioral|mWACh-PrEP|Participants randomized to mWACh-PrEP will be registered into the system, in addition to receipt of SOC services. Women registered into the mWACh-PrEP platform will indicate their preferences for message delivery including a preferred name for messaging, language (English or Kiswahili or Dholuo), and day of the week and time for SMS delivery. Once registered, women will receive weekly automated push messages on the day/time of their choice from enrollment through 6-months postpartum. All automated push messages will include participant nickname, clinic and nurse name, an educational message or actionable advice targeting PrEP adherence and continuation and/or MCH topics, and a question related to the content. SMS topics will include adherence encouragement, PrEP efficacy and safety, self-efficacy for prevention of HIV, support for potential PrEP side effects, behavioral skills (tips for remembering PrEP medications) and visit reminders.
15797379|NCT04472884|Other|Standard of Care|All participants will receive SOC services for MCH and PrEP that will include health education, clinical assessments, laboratory safety monitoring, STI (syphilis, gonorrhea, and chlamydia) screening and treatment (including expedited partner treatment for
15797380|NCT04472871|Device|Left atrial appendage closure|The left atrial appendage (LAA) is a small, ear-shaped sac in the muscle wall of the left atrium (top left chamber of the heart). It is unclear what function, if any, the LAA performs. In patients with heart failure and atrial fibrillation, reduced left atrial appendage (LAA) emptying velocities leads to LAA thrombus formation therefor a higher rate of stroke and embolism are observed even on oral anticoagulants. FDA approved devices for left atrial appendage closure will be used under guidance of angiography and trans-esophageal echo with highly efficient and trained personnel.
15797381|NCT04472858|Drug|Donafenib|dose escalation: Donafenib 100 mg QD/100 mg BID/200 mg BID (p.o.). dose expansion: Patients will be assigned to specific tumor types and treated at the recommended dose for dose escalation.The recommended dose for dose escalation will be determined by the dose escalation study.
15797382|NCT04472858|Drug|CS1001|CS1001 will be administrated by intravenous (i.v.) infusion once every 28 days
15797383|NCT04472845|Radiation|1 week RT|RT will be delivered over 1 week
15797384|NCT04472845|Radiation|2 week RT|RT will be delivered over 2 week
15797385|NCT04472832|Drug|Placebo for Treatment A|6 tablets matched to mitapivat tablet
15797386|NCT04472832|Drug|Mitapivat 100 mg|Two 50-mg tablets
15797387|NCT04472832|Drug|Placebo for Treatment B|4 tablets matched to mitapivat tablet
15797388|NCT04472832|Drug|Mitapivat 300 mg|Six 50-mg tablets
15797389|NCT04472832|Drug|Placebo for Treatment C|4 tablets matched to mitapivat tablet
15797390|NCT04472819|Drug|SHR2285 tablet|single dose or multi-dose
15797391|NCT04472819|Drug|Placebo|single dose or multi-dose
15797392|NCT04472806|Drug|Toripalimab|"Toripalimab, humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically.
~Toripalimab treatment after chemotherapy in combination with Endostar, 240 mg, Q3W, up to 2 years."
15797394|NCT04472793|Diagnostic Test|SARS-CoV-2|"Testing weekly samples from nasal swabs to promptly diagnose acute COVID-19 infection.
~Testing monthly serum samples to document post-viral infection."
15797395|NCT04472780|Device|Hyperbaric oxygen Therapy HBOT|HBOT therapy protocol: in an eight-seat hyperbaric chamber 40 sessions of HBOT duration: 1 hour rhythm: 5 sessions / week pressure: 1.7 ATA (7 meters) O2 concentration: 100%
15797396|NCT04472767|Drug|Nivolumab|Given IV
15797397|NCT04472767|Drug|Ipilimumab|Given IV
15797398|NCT04472767|Drug|Cabozantinib|Given PO
15797399|NCT04472767|Procedure|Transarterial Chemoembolization|TACE treatment will be administered using either the DEB-TACE or cTACE modality in a series of up to 3 individual procedures within the 9-12 weeks following Day 21 (= cycle 1 day 21) of a patient's first infusion of nivolumab/ipilimumab. The first TACE treatment should start no more than 7 working days after being cycle 1 day 21.
15797400|NCT04472741|Device|difference between colonoscopes|patients have been randomly assigned for colonoscopy with FUSE or HD SFV endoscopes with or without Endocuff
15797401|NCT04472728|Drug|BIO101|BIO101 capsules
15797402|NCT04472728|Drug|Placebo|placebo capsules
15797403|NCT04472715|Procedure|follicular unit extarcation and platelet rich plasma|hair transplantation procedure
15797404|NCT04472702|Procedure|cRFA|cRFA intervention will occur under sterile conditions, the patient will be placed in a supine position on a table and a bolster to provide flexion in the treated knee joint. Skin and soft tissues will be anaesthetized with 2 mL 1% lidocaine at each of the three anatomic sites for cRFA, and a introducer needle will then be placed under ultrasound or fluoroscopic guidance to the SLG, SMG, and IMG nerves. Adjustments at these positions will be made when using ultrasound guidance in order to capture the geniculate nerve if the nerve and/or its accompanying vasculature can be directly visualized using greyscale or Doppler modes. When using ultrasound, the physician will note and record whether their positioning of the needle is based on bony landmarks, direct visualization of the nerve, and/or vascularity accompanying the nerve. Once the introducer needle is placed, the cRFA will be placed into the introducer needle.
15797405|NCT04472689|Drug|Lidocaine|patients will receive a loading dose of IV lidocaine 1.5mg/kg slowly diluted with 20 ml normal saline just before induction of anesthesia, then the lidocaine infusion started at a rate of 2mg/kg/h diluted in normal saline by rate of 2 ml/ kg/h.
15797406|NCT04472689|Drug|Normal saline|patients will receive an equal volume of normal saline (both the loading, and the infusion). The infusion in both groups will be started just after induction of anesthesia induction, and continued until the end of the operation
15797407|NCT04472676|Drug|LY3473329|Administered orally.
15797408|NCT04472676|Drug|Placebo|Administered orally.
15797409|NCT04472650|Drug|Sitravatinib|Administered as a free base capsule
15797410|NCT04472650|Drug|Sitravatinib|Administered as a malate salt capsule
15797411|NCT04472637|Drug|Atorvastatin|atorvastatin 10 mg, as one tablet /day for 24 weeks.
15797412|NCT04472637|Drug|Placebo|a placebo in the form of multivitamin tablets similar to the experimental drugs with the same regimen (one tablet /day for 24 weeks)
15797413|NCT04472624|Other|Fasting|Acute fasting for 72 hours
15797414|NCT04472624|Other|Ketogenic diet|Intake of a ketogenic diet for 14 days
15797415|NCT04472611|Drug|Standard of Care (SOC) and Colchicine+Rosuvastatin|Patients will take Rosuvastatin 40mg daily and Colchicine 0.6mg twice for 3 days and then 0.6mg daily during hospitalization
15797419|NCT04472585|Drug|Ivermectin Injectable Solution|Subcutaneous Ivermectin 200ug/kg body weight 48 hourly
15797420|NCT04472585|Other|Injectable Placebo|0.9% normal saline
15797421|NCT04472585|Drug|Zinc|Zinc Sulphate 20mg 3 times a day
15797422|NCT04472585|Drug|Placebo empty capsule|Placebo empty capsule
15797423|NCT04472585|Drug|Oral Ivermectin|0.2mg/kg/day
15797424|NCT04472572|Biological|Convalescent Plasma|Fresh or frozen plasma will be infused one time to patients with COVID-19 infection
15797425|NCT04472559|Behavioral|Self-acupressure|Self-acupressure
15797426|NCT04472546|Other|in-vivo mesure|"for acne of the face subgroup and its associated control : face and inner side of the forearm
~for atopic dermatitis of the upper limb subgroup and its associated control: upper limb (hand excluded) and inner side of the forearm
~for vulgar plaque psoriasis subgroup and its associated control: upper limb (hand excluded) or lower limb and inner side of the forearm
~for telangiectasic erythrocouperosis papule of the face (rosacea) subgroup and its associated control: face and inner side of the forearm
~for seborrheic dermatitis of scalp subgroup and its associated control: scalp and inner side of the forearm"
15797427|NCT04472546|Other|Scotch|"for acne of the face subgroup and its associated control : face and inner side of the forearm
~for atopic dermatitis of the upper limb subgroup and its associated control: upper limb (hand excluded) and inner side of the forearm
~for vulgar plaque psoriasis subgroup and its associated control: upper limb (hand excluded) or lower limb and inner side of the forearm
~for telangiectasic erythrocouperosis papule of the face (rosacea) subgroup and its associated control: face and inner side of the forearm
~for seborrheic dermatitis of scalp subgroup and its associated control: scalp and inner side of the forearm"
15797428|NCT04472546|Other|Lipid index|"for acne of the face subgroup and its associated control : face
~for seborrheic dermatitis of scalp subgroup and its associated control: scalp
~for telangiectasic erythrocouperosis papule of the face (rosacea) subgroup and its associated control: face"
15797429|NCT04472546|Other|Absorbant paper|"for acne of the face subgroup and its associated control : face
~for seborrheic dermatitis of scalp subgroup and its associated control: scalp
~for telangiectasic erythrocouperosis papule of the face (rosacea) subgroup and its associated control: forehead"
15797430|NCT04472546|Other|Hydratation Index|-for atopic dermatitis of the upper limb subgroup and its associated control: upper limb (hand excluded)
15797431|NCT04472546|Other|TransEpidermal Water Loss|-for atopic dermatitis of the upper limb subgroup and its associated control: upper limb (hand excluded)
15797432|NCT04472520|Device|AliveCor Heart Monitor|Records single-channel ECG rhythms
15797433|NCT04472494|Biological|Abatacept|Specified dose on specified days
15797434|NCT04472494|Other|Placebo|Specified dose on specified days
15797435|NCT04472481|Drug|Ergocalciferol 1.25 mg tablet|weekly 50000 IU of Vitamin D2 (Ergocalciferol 1.25 mg tablet) given orally group II
15797436|NCT04472468|Device|Percutaneous Balloon Pericardiotomy|"Subxiphoid approach under fluoroscopic guidance is used.
~An 20mm over-the-wire ultra-non-compliant Percutaneous Transluminal Angioplasty Balloon is advanced into the pericardial space.
~Success of balloon pericardiotomy is confirmed by full inflation of the balloon which is confirmed on two orthogonal projections."
15797437|NCT04472455|Diagnostic Test|HRME|
15797438|NCT04472442|Procedure|Intermittent hypoxia|"Acute intermittent treatment (AIH) will be initiated using an oxygen generator (Model HYP-123, Hypoxico Inc, New York, NY, and participants will be seated comfortably and fitted with a non-rebreather mask. AIH (using 9% O2) will be provided in 60 s intervals and repeated 15 times with alternating 60 s intervals of normoxia (21% O2). Continuous pulse oximetry (Masimo 7, Irvine CA) will be monitored to ensure oxygen saturation of 82-85%. Signs and symptoms of distress with AIH exposure will be noted throughout, with HR and blood pressure taken every 3-5 minutes and documented.
~High-intensity training will then be performed (40 min of walking training up to 70-80% maximum heart rate within 1 hr)."
15797439|NCT04472442|Procedure|Sham hypoxia|"Sham acute intermittent treatment (sham AIH) will be initiated using an oxygen generator (Model HYP-123, Hypoxico Inc, New York, NY, and participants will be seated comfortably and fitted with a non-rebreather mask. Sham AIH (using 20% O2) will be provided in 60 s intervals and repeated 15 times with alternating 60 s intervals of normoxia (21% O2). Continuous pulse oximetry (Masimo 7, Irvine CA) will be monitored to ensure oxygen saturation of 82-85%. Signs and symptoms of distress with AIH exposure will be noted throughout, with HR and blood pressure taken every 3-5 minutes and documented.
~High-intensity training will then be performed (40 min of walking training up to 70-80% maximum heart rate within 1 hr)."
15797440|NCT04472429|Drug|carboplatin|carboplatin will be administered intravenous on Day 1 of each 28 day cycle
15797441|NCT04472429|Drug|paclitaxel|paclitaxel will be administered intravenous on Days 1,8, and 15 of each 28 day cycle
15797442|NCT04472429|Drug|retifanlimab|retifanlimab will be administered intravenous on Day 1 of each 28 day cycle
15797443|NCT04472416|Device|VRD in addition to standardized analgesic protocol|Use of VRD in addition to standardized analgesic protoco for abdominal VAC dressing change
15797444|NCT04472377|Device|Self sampling kit for collecting discharge from vaginal fornix|A device to collect exfoliative cells from vaginal fornix that can self-operated with ease and comfort.
15797445|NCT04472364|Device|HemoPill Acute ®|Capsule positive: Endoscopy endoscopy will be performed within 12 hours. Capsule negative: Endoscopy will be performed after 48 to 96 hours.
15797446|NCT04472351|Behavioral|ASCEND-I|"The intervention is an inpatient version of a novel behavioral intervention named ASCEND (A Strategy and Computer-based Intervention to ENhance Daily Cognitive Functioning after Stroke). ASCEND-I combines computer-based cognitive training exercises, with structured coaching sessions within patients' occupational therapy. Computer-based training is 30 minutes in length daily, and strategy training within patients' occupational therapy ranges from 30-60 minutes (depending on patients' clinical goals). The computer exercises aim to improve working memory (WM) through a series of engaging and interactive computer games (e.g., card games, virtual shopping, mental arithmetic). The Multicontext OT sessions aim to assist the participant in generalizing and transferring skills from the computer exercises to everyday activities and to develop further strategies to compensate for WM difficulties."
15797451|NCT04472299|Drug|Ropivacaine 0.2% Injectable Solution|Patients in the intervention group will have ultrasound guided bilateral T3 paravertebral catheters placed prior to surgery. Prior to surgery, these patients will have 5ml of 1.5% lidocaine with 1:200,000 epinephrine injected in each catheter. Ropivacaine 0.2% will be administered via programmed intermittent bolus of 7ml every 60 minutes through each catheter during and after surgery.
15797452|NCT04472273|Procedure|high-flow nasal cannula / classic nasal cannula|The oxygen given with nasal cannula cannot be humidified, causing drying in mucous membranes at high flow rates of more than 4L/min and problems in patient compliance.This situation prevents us to increase the oxygen FiO2 rate applied to the patient above 40%.According to the nasal cannula high-flow nasal cannula where heated and humidified oxygen can be delivered, oxygen therapy can be applied at a flow rate of 25L/min.It provides high flows easily, prevents the airway epithelium from drying out and improves mucus cleansing, causing a decrease in anatomical dead space.It provides discharge of expired air in the upper airways.It increases alveolar ventilation.It offers a stream adjusted to all children.Flow and titration can be adjusted according to the child's weight and effect.
15797454|NCT04472247|Diagnostic Test|Continuous EEG and EMG monitoring, with derived variables|All patients are monitored during their ICU stay by frontal EEG and EMG measuring devides, which are already in clinical use.
15797455|NCT04472234|Other|BPA levels|BPA (Bisfenol A) in urine, blood and follicle fluid samples
15797456|NCT04472221|Procedure|Arterioarterial synthetic graft|Synthetic poly tetraflouroethylene graft
15797457|NCT04472208|Device|Ambulatory monitoring solution|Subjects participating in this study will be monitored with the site's standard of care primary monitor and the evaluable device as the secondary monitor.
15797458|NCT04472195|Other|Simulation Airway Coaching|Airway coaching on laryngoscopy technique for intubation of neonates/infants within 1 hour of case utilizing RCDP simulation technique.
15797459|NCT04472182|Drug|Fluoride varnish with xylitol coated calcium and phosphate|Fluoride varnish with xylitol coated calcium and phosphate
15797460|NCT04472156|Procedure|Transfer of mosaic embryo|Subjects will transfer a mosaic embryo transferred to their uterus
15797461|NCT04472143|Drug|Granisetron Transdermal Delivery System|A total of 60 patients with HER2-positive advanced breast cancer who are scheduled to receive pirotinib combined with capecitabine will be enrolled. A single transdermal patch will be applied to the subject' upper outer arm 24-48 hours before chemotherapy for 7 days. The observation period will be from the time of enrollment to 14 days (± 7 days) after the removal of granisetron patch.
15797462|NCT04472117|Other|usual care|Interviews will be conducted in person or by telephone by an MD on the research team who does not have an ongoing treatment relationship with the patient, and has been trained by the qualitative methods specialist. Interviews will take place over the phone or in person and are anticipated to last approximately 20-30 minutes.
15797463|NCT04472117|Other|Educational video|Watch an educational video created by the research team and.will also complete the post-video survey,
15797464|NCT04472104|Behavioral|MBCT-S|Group mindfulness treatment for sexual desire, sexual distress, and sexual pain in breast cancer (BrCa) survivors.
15797465|NCT04472104|Behavioral|SexEd|Group sex education on sexual desire, sexual distress, and sexual pain in breast cancer (BrCa) survivors.
15797466|NCT04472091|Device|Genicular artery embolization (GAE)|Participants will undergo GAE with HydroPearl® Microspheres (polyethylene glycol microspheres, Terumo Medical, Somerset NJ).
15797467|NCT04472078|Diagnostic Test|Serological Assay or IgG for SARS-CoV-2|Serological Assay for detection of IgG for SARS-CoV-2
15797468|NCT04472065|Dietary Supplement|Lactobacillus reuteri|1 chewable tablet of probiotic dietary supplement (200 million CFU of L. reuteri DSM 17938 and ATCC PTA 6475) consumed once per day orally for 6 weeks beginning at Baseline (between 1 to 3 days postpartum) to 6 weeks postpartum.
15797469|NCT04472065|Other|Placebo|1 chewable placebo tablet containing all the same ingredients except L. reuteri (DSM 17938 and ATCC PTA 6475) consumed once per day orally for 6 weeks beginning at Baseline (between 1 to 3 days postpartum) to 6 weeks postpartum.
15797470|NCT04472052|Other|appendectomy|Surgical standard treatment for acute appendicitis All patients receive preoperative single-shot antibiosis, usually 2000 mg cefotaxime combined 500 mg metronidazole. Appendectomy is performed usually within 24 h of admission in patients with acute appendicitis. The laparoscopic appendectomy using the 3-trocar technique represents the surgical standard. In uncomplicated or non-perforated appendicitis, drainage is generally not required. Wounds are closed intra-cutaneous with absorbable sutures. Patients without postoperative complications are discharged home two days after surgery.
15797471|NCT04472039|Device|optical coherence tomography (OCT)|OCT visualizes the retinal layers by backreflection of light
15797473|NCT04472013|Other|Data collection from lumbar puncture|Cerebro spinal fluid (CSF) will be acquired by lumbar puncture and sent for routine analysis including CSF chemistry, cytology and microbiology. Targeted CSF proteomics using OLINK Proximity Extension Assay (PEA) technology to assess a potential CNS-contribution of the disease will be performed.
15797474|NCT04472013|Other|Data collection from blood draw|Plasma samples will be acquired for plasma cytokine proteomics using CyTOF (mass cytometry analysis) technology.
15797475|NCT04472013|Other|CNS magnetic resonance imaging (MRI) imaging|3Tesla magnetic resonance imaging (MRI) will be performed to document early/manifest encephalitic changes in COVID-19 patients.
15797476|NCT04472013|Other|Microscopy of defined brain regions on autopsy specimens|High dimensional, microglia-centric CODEX fluorescent microscopy of defined brain regions on autopsy specimens will be acquired from medulla oblongata, cortex, cerebellum, and olfactory bulb. A brain-specific CODEX panel for the assessment of the immune microenvironment was implemented, with inclusion of a wide array of myeloid/microglia markers, T-cell markers, and a few neuronal markers. All the antibodies have been validated and tested in formalin-fixed tissues of different zones of glioblastoma tumors including invading tumor periphery. The Panel will be modified to include the viral entry receptors, CD147, ACE2 and TMPRSS2. Presence of SARS-CoV-2 virus particles will be assessed by qPCR, andMultiplexed Ion Beam Imaging (MIBI) technology will be used to visualize tropism of virus to specific cellular brain compartments.
15797477|NCT04472000|Drug|Vitamin C|Study participants in the verum group receive one capsule of Burgerstein Vitamin C retard 500mg b.i.d. with treatment starting in the evening on the day of the operation for a total of 50 days.
15797478|NCT04472000|Drug|Placebo|The placebo group receives one placebo capsule b.i.d. with treatment starting in the evening on the day of the operation for a total of 50 days.
15797479|NCT04471987|Drug|IL12-L19L19|"Part I - The dose escalation is designed with an initial accelerated phase followed by a standard 3+3 design. Cohorts contain one patient until first instance of moderate toxicity or a DLT in the DLT observation period (28 days). With the second occurrence of moderate toxicity or occurrence of a DLT the accelerated phase will be terminated and the dose escalation will continue with a 3+3 dose escalation. Initiation of the study treatment for an individual subject will occur not less than 7 days after initiation of the study treatment for the previous patient. Not more than 2 patients are to be treated simultaneously within their DLT observation period (i.e., Day 1 to Day 28).
~Part II - Dose expansion: Once the dose escalation is completed, additional 40 patients will be enrolled at the RD to better understand the safety profile and to explore early signs of efficacy in different disease indications."
15797480|NCT04471974|Drug|BET Bromodomain Inhibitor ZEN-3694|Given PO
15797481|NCT04471974|Drug|Enzalutamide|Given PO
15797482|NCT04471974|Biological|Pembrolizumab|Given IV
15797483|NCT04471961|Genetic|Exome sequencing in pediatrics cancers|This pediatric oncology study proposing a global approach integrating trio-based whole exome sequencing, somatic DNA and RNA analysis will improve the recognition of genetic predisposition and the characterization of target therapies in children with cancer.
15797484|NCT04471948|Device|Fractional picosecond 1064 nm laser|The parameter of laser was 8 mm spot size, 0.8 mJ/CM2, 750 ps, 5 Hz, 2 passes The treatment was done in every 4 weeks for 3 sessions.
15797485|NCT04471935|Device|At home Speech Hero therapy app|Participants will be instructed to use the Speech Hero therapy app for three hours per week over a 3-week period.
15797643|NCT04470427|Biological|Placebo|0.9% sodium chloride (normal saline) injection
15797486|NCT04471922|Drug|Anaprazole Sodium enteric-coated tablet|Multiple ascendinng dose, anaprazole 60mg QD(60mg QD group), 80mg QD(80mg QD group), 100mg QD(100mg QD group) , 7 days, fasting oral administration.
15797487|NCT04471922|Drug|Placebo|Multiple dose, 1 tablet QD (60mg QD,80mg QD and 100mg QD group), 7 days, fasting oral administration.
15797488|NCT04471922|Drug|Active controlled (rabeprazole)|Multiple dose, rabeprazole 20mg QD (60mg QD,80mg QD and 100mg QD group), 7 days, fasting oral administration.
15797489|NCT04471909|Device|NEXUS Aortic Stent Graft System|"Arch Stent Graft, whose cranial narrow end is intended to be deployed into the Brachiocephalic artery and whose distal end is intended to be deployed into the Descending Thoracic Aorta.
~Ascending Stent Graft intended to be deployed in the Ascending Aorta.
~OPTIONAL: Descending Extension can be used in case the aortic lesion elongates further distally and out of the covered length offered by the Arch Stent Graft. Multiple Descending Extensions can be used if needed to cover the entire length of the lesion."
15797490|NCT04471896|Device|Joovv Mini|Infrared light therapy uses certain wavelengths of light that are delivered to the face. This study will use the Joovv Mini.
15797491|NCT04471883|Procedure|Percutaneous coronary interventions|Percutaneous coronary interventions in coronary bifurcation lesions
15797492|NCT04471857|Behavioral|Hypnosis|
15797494|NCT04471831|Other|Rehabilitation exercise protocol|"The exercise package will then be sent to them after securing video contact with the prospective participant. Only participants with smart phone that can receive the video package will be selected for this study.
~Physiotherapy-Patients' Engagements At every morning after their prescribed drugs might have been served in the ward, the physiotherapist will call the participant for the exercises. The patient will be connected to the physiotherapist who is in his clinic (not in the isolation ward with the patients) through a WhatsApp or zoom video call. The physiotherapist will control the rhythm and pace of the exercises through the video interactions."
15797495|NCT04471818|Drug|Ketamine|Ketamine (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study
15797496|NCT04471818|Other|Placebo|Placebo (0.5 mg/kg) will be administered intravenously once every week to patients in the experimental arm of the study
15797497|NCT04471805|Device|Sham transcranial direct current stimulation 2 mA|Uses weak electrical current (2 mA intensity) at the beginning and the end of a given stimulation period to control for potential placebo-like effects or participant expectation bias.
15797498|NCT04471805|Device|Transcranial direct current stimulation 2 mA|Uses weak electrical current (2 mA intensity) to either increase or decrease brain excitability and improve functional or cognitive outcomes.
15797499|NCT04471805|Device|Sham transcranial direct current stimulation 4 mA|Uses weak electrical current (4 mA intensity) at the beginning and the end of a given stimulation period to control for potential placebo-like effects or participant expectation bias.
15797500|NCT04471805|Device|Transcranial direct current stimulation 4 mA|Uses weak electrical current (4 mA intensity) to either increase or decrease brain excitability and improve functional or cognitive outcomes.
15797501|NCT04471792|Drug|Creatine monohydrate|Creatine monohydrate will be used in combination with muscle stretching.
15797502|NCT04471792|Dietary Supplement|Cellulose|Cellulose will be used in combination with muscle stretching.
15797503|NCT04471779|Other|Disclosure of APOE genotype|Information about risk of Alzheimer's disease will be given to participants based on their APOE genotypes, in addition to Latino ethnicity and family history.
15797504|NCT04471766|Other|Certified cloth face mask plus preventive information|Provision of two face masks sewed locally following a certified model tested for FORCE in the laboratory per residents > 10 years old
15797505|NCT04471766|Behavioral|Preventive information|Advice on how to prevent COVID-19 according to the government´ policy
15797506|NCT04471753|Behavioral|Coma Recovery Scale-Revised|Data were collected according to the Coma Recovery Scale-Revised operation guideline, the sum of the highest score on the evaluated subscales was taken as the final score, and the final diagnosis of patients was obtained (the highest score of each subscale was recorded). All participants were diagnosed by using CRS-R five times at least within 7 days. According to the results of the Coma Recovery Scale-Revised assessment, minimally conscious state and unresponsive wakefulness syndrome were distinguished.
15797507|NCT04471740|Procedure|CSF shunt diversion|Clinical response to a CSF shunt insertion
15797508|NCT04471727|Drug|HPN328|HPN328 is a tri-specific recombinant protein construct (Tri-specific T Cell Activating Construct [TriTAC®]) containing 3 humanized antibody derived binding domains
15797509|NCT04471714|Drug|Baclofen|Participants will come in for two visits. In a randomized manor, they will receive baclofen on one visit and a placebo on the other. During each visit the soleus H-reflex will be measured and conditioned by common peroneal nerve stimulation to assess presynaptic inhibition.
15797510|NCT04471701|Behavioral|Environmental exposure and clinical features|Environmental exposures and clinical features are measured by means of a self-administered 38-item on-line questionnaire containing mainly mandatory and closed questions divided into six sections: i) socio-demographic data; ii) clinical evaluation; iii) personal characteristics and health status; iv) housing conditions; v) lifestyle; and vi) behaviours following the lockdown.
15797511|NCT04471688|Diagnostic Test|infectious disease screening|Explore the best detection strategy for patients with pre-transfusion/pre-operative infectious disease screening
15797512|NCT04471675|Drug|Albumin-bound docetaxel|Albumin-bound docetaxel by intravenous infusion.
15797513|NCT04471636|Device|Withings ScanWatch|The smart watch is capable of recording SpO2, ECG, and heart rate.
15797514|NCT04471623|Device|DeTAP App and Home Devices|DeTAP App (data collection, televisit function, information and reminders), Bluetooth-connected 6-lead home (electrocardiogram) EKG device, Bluetooth-connected blood pressure (BP) cuff
15798131|NCT04466618|Biological|Exendin-9,39 + Intralipid/Heparin|Exendin-9,39 infused during acute insulin resistance
15797515|NCT04471610|Other|Serial measurements of NT-pro BNP, potassium, sodium, and creatinine every second business day|Serial measurements of NT-proBNP, sodium, potassium, and creatinine in the NT-proBNP-group vs. no serial measurements in control group. In the intervention group the body weight, vital parameters, therapy changes and adverse events are documented the above mention serial measurement every second business day.
15797516|NCT04471597|Drug|normal saline 0.9%|5ml of normal saline 0.9% topically 15 min will be installed topically around the ETT using ordinary syringe before the expected end of the surgery, this will be followed by manual ventilation using about the double tidal volume for 6-8 times or more to get air bubbles distributed within the upper airway to anesthetize the oropharynx and spread around ETT to the adjacent mucosal structures (laryngopharynx, larynx, and upper part of the trachea) then the cuff will be inflated to the previous pressure and the patient will be mechanically ventilated as usual.
15797517|NCT04471597|Drug|Bupivacaine Hydrochloride|5 ml of bupivacaine 0.5% will be installed topically around the ETT using ordinary syringe before the expected end of the surgery, this will be followed by manual ventilation using about the double tidal volume for 6-8 times or more to get air bubbles distributed within the upper airway to anesthetize the oropharynx and spread around ETT to the adjacent mucosal structures (laryngopharynx, larynx, and upper part of the trachea) then the cuff will be inflated to the previous pressure and patient will be mechanically ventilated as usual.
15797518|NCT04471584|Device|Insertion of ILR device|All patients enrolled will be randomized to have one of three ILR devices implanted (BIOMONITOR III, Reveal LinQ, or Confirm RX) and will be given event monitoring device for concurrent evaluation.
15797519|NCT04471571|Other|Resin infiltration and microabrasion for MIH-affected incisors|MIH-affected incisors will be treated with microabrasion followed by resin infiltration as a combined treatment
15797520|NCT04471571|Other|Resin infiltration for MIH-affected incisors|MIH-affected incisors will be treated with resin infiltration alone
15797521|NCT04471558|Other|Music|A part of the RCT will be performed with music in the room. The music will be switch on just before anesthesia and off after the postoperative rest.
15797522|NCT04471545|Procedure|Pectoral nerve block type II|A pectoral nerve block type II will be given to the patient after induction. This is performed ultrasound guided
15797523|NCT04471532|Behavioral|Behavior change intervention|"It is a 3-month, multimodal, minimal contact, pedometer-driven, behavior change intervention to promote and support physical activity, that is initiated 3 months after THA. There is one initial, physiotherapist-led, face-to-face, physical activity counselling including 1) a brief motivational interviewing regarding physical activity, 2) patient education regarding physical activity after THA including recommendations and safety based on an orthopedic surgeon guided video and leaflet, 3) handling out pedometer and educational material i.e. a practice-oriented leaflet with advice on how to use a pedometer, a step-calendar and goal setting as well as strategies to incorporate physical activity into daily life. This initial counselling is followed by two, physiotherapist-led, telephone-assisted counselling after respectively three and seven weeks."
15797524|NCT04471519|Biological|BBV152A - Phase I|0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14
15797525|NCT04471519|Biological|BBV152B - Phase I|0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14
15797526|NCT04471519|Biological|BBV152C - Phase I|0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 14
15797527|NCT04471519|Biological|Placebo - Phase I|0.5 ml of the Placebo will be administered intramuscularly twice at Day 0 and Day 14
15797528|NCT04471519|Biological|BBV152A - Phase II|0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 28
15797529|NCT04471519|Biological|BBV152B - Phase II|0.5 ml of the vaccine will be administered intramuscularly twice at Day 0 and Day 28
15797530|NCT04471506|Other|interval training in addition to diet recommendations|Ixercise program in form of a cycling protocol which will be comprised 5 minutes of warming up before exercise initiation and another 5 minutes for cooling down by the end of the exercise session in the form of slow pedaling (50% of PHR). The work interval also will be consisted of 8-12 cycling intervals (60s cycling work interval with 120s of passive rest or low-intensity cycling (70% of PHR) between work intervals that progressively will be reduced until reaching 90s by the end of the exercise program).
15797531|NCT04471506|Other|diet recommendations|the control group will follow diet recommendations for 12 weeks
15797532|NCT04471480|Drug|TC/PD-1 inhibitor/anlotinib|chemotherapy and immunotherapy plus antiangiogenic therapy
15797533|NCT04471467|Procedure|Fixed tracheal tube|Tracheal tube fixation is determined by the surgeon according to the needs of the operation and is an independent process. Our research simply installed a monitoring device between the tube and the nose. The tube fixation takes place whether the observation of pressures is agreed to or not, as per standard protocol.
15797534|NCT04471441|Drug|Everolimus Tab.|After first dose 1mg BID(total 2mg daily PO), check the blood concentration of everolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3~8ng/mL.
15797535|NCT04471441|Drug|Mycophenolate mofetil Tab./Cap.|Up to 1.5g BID(total 3g daily), PO
15797536|NCT04471428|Drug|Cabozantinib|Cabozantinib will be administered orally, once daily at a dose of 40 mg on Days 1-21 of each cycle.
15797537|NCT04471428|Drug|Atezolizumab|Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.
15797538|NCT04471428|Drug|Docetaxel|Docetaxel will be administered by IV infusion at a starting dose of 75mg/m2 on Day 1 of each 21-day cycle.
15797539|NCT04471415|Drug|DRP-104|"DRP-104 administered intravenously over 1 hour, three times per week (TIW) (Monday, Wednesday, Friday) for 2 consecutive weeks, one week off
~DRP-104 administered subcutaneously twice weekly (Monday/Thursday or Tuesday/Friday) every week"
15797540|NCT04471415|Biological|atezolizumab|atezolizumab administered intravenously over 1 hour at 1200 mg once every 3 weeks.
15797541|NCT04471402|Drug|Precedex|Intranasal Precedex 3mcg/kg
15797542|NCT04471389|Other|Incidence and risk factors of hypertension|During the follow-up period, General information(age, sex, BMI, blood pressure, the history of drink and smoke, medical history, etc). Blood biochemistry parameters（Lipid, hsCRP levels, etc）and other laboratory examination parameters(arterial stiffness, IMT, FMD) will be collected.
15797543|NCT04471376|Drug|Sugammadex|Sugammadex group received a rocuronium infusion producing blockade by qualitative train-of-four ≥2 at the ulnar nerve. 2 mg/kg of Sugammadex will be infused when conducting TcMEP
15797544|NCT04471363|Behavioral|Cancer-Specific Exercise education|An audio-recorded PowerPoint presentation created by the study team on the benefits of exercise for survivors, caregivers and romantic couples.
15797545|NCT04471350|Device|HEMOBLAST™ Bellows|Surgeon has chosen to use HEMOBLAST™ Bellows as an adjunct to hemostasis when control of minimal, mild, or moderate bleeding by conventional procedures is ineffective or impractical in spine surgery.
15797546|NCT04471337|Drug|BAY1817080|BAY1817080 will be administered orally as tablet.
15797547|NCT04471324|Device|EBUS cryo probe|patients receive a transbronchial cryo biopsy with the EBUS cryo probe from ERBE and an ultra thin bronchoskope
15797548|NCT04471311|Procedure|Sub-lay mesh supported closure|A 4 cm space is created between posterior rectus sheath and rectus muscle, widening 2 cm at each side of midline. Both posterior rectus sheath edges are sutured using a running slowly absorbable suture. Above the arcuate line, posterior layer is reinforced suturing the peritoneum and the posterior rectus sheath; below the arcuate line, the posterior layer is reinforced suturing the peritoneum and the trasversalis fascia. Anterior layer is re-established suturing the anterior rectus sheath. A 3 cm BIO-A Mesh strip is sutureless placed between the posterior rectus sheath and the rectus muscle with an overlap of 1,5 cm at each side. In laparotomies >20 cm two stripes of 15 cm each is designed. The midline anterior rectus sheath is closed using a running slowly absorbable suture , covering the mesh.
15797549|NCT04471311|Device|BIO-A (GORE) mesh|3 cm BIO-A Mesh strip
15797550|NCT04471298|Drug|Qishenyiqi dripping pills, 6 bags|28 consecutive days
15797551|NCT04471298|Drug|Qishenyiqi dripping pills, 9 bags|28 consecutive days
15797552|NCT04471298|Drug|Qishenyiqi dripping pills, 12 bags|28 consecutive days
15797553|NCT04471298|Drug|Qishenyiqi dripping pills placebo, 6 bags|28 consecutive days
15797554|NCT04471298|Drug|Qishenyiqi dripping pills placebo, 9 bags|28 consecutive days
15797555|NCT04471298|Drug|Qishenyiqi dripping pills placebo, 12 bags|28 consecutive days
15797556|NCT04471285|Procedure|acupuncture|acupuncture
15797557|NCT04471285|Procedure|Sham acupuncture|Sham acupuncture
15797558|NCT04471272|Procedure|RFA using gradual RF energy delivery mode with Octopus electrodes|RFA therapy is performed on HCC less than 4 cm in size using an octopus electrode, a double-shift unipolar high-frequency transmission mode, and a gradual high-frequency energy loading mode.
15797559|NCT04471259|Other|Classification statistics|We classified patients by gender, age, recovery time,etc
15797560|NCT04471246|Drug|Cephalexin|1000 mg PO QID for 7 days
15797561|NCT04471246|Drug|Cephalexin|500 mg PO QID plus oral placebo for 7 days
15797562|NCT04471233|Other|Multimodal analgesia including pregabalin|Standardized protocol for our institution with multiple medications used for pain (NSAIDs, opioids, dexamethasone) and non-narcotic spinal. Patient will be provided with an preoperative pregabalin dose and will continue medication two weeks postoperatively.
15797563|NCT04471233|Other|Multimodal analgesia not including pregabalin|Standardized protocol for our institution with multiple medications used for pain (NSAIDs, opioids, dexamethasone) and non-narcotic spinal.
15797564|NCT04471220|Device|High-flow nasal cannula|The nasal high flow therapy has enabled high flow oxygen to be derived through nasal cannula. This mode not only allows constant FiO2 during peak inspiratory flow but also confers benefits including a low level of continuous positive airway pressure with increased end-expiratory lung volume and reduced work of breathing, partly through intrinsic positive end-expiration pressure compensation and dead space washout. The inspired gases are warmed and humidified, improving comfort and possibly reducing airway inflammation, leading to improved drainage of respiratory secretions.
15797565|NCT04471207|Device|Therapist Guided Prolonged Exposure with BioWare Device|Experimental: Intelligent Biometrics - Prolonged Exposure (therapist guided). In the therapist guided group, Study Therapists will use actionable data during IVEs (e.g., HR, GSR, SUDS) to modify the assignments in real-time.
15797566|NCT04471207|Device|Record Only Prolonged Exposure with BioWare Device|In the record-only group, passive data collection will be utilized to collect and store biometric and behavioral data for future offline analyses to investigate predictors of outcome.
15797567|NCT04471194|Diagnostic Test|Self-sampling HPV test|Tests for human papillomavirus from cervical cell sample
15797568|NCT04471194|Diagnostic Test|Fecal occult blood test|Tests for human hemoglobin from blood in fecal samples
15797569|NCT04471181|Device|Endovascular repair of ruptured abdominal aortic aneurysm (EVAR) with Medtronic Endurant|Endovascular repair (EVAR) of ruptured abdominal aortic aneurysms with Medtronic Endurant II, and IIs device
15797570|NCT04471168|Device|Cryo-Auriculotherapy|3 sessions of cryo-auriculotherapy with device with nitrous oxyde on 10 auricular points at one month intervals.
15797571|NCT04471168|Device|Sham comparator|3 sessions of cryo-auriculotherapy with device without nitrous oxyde on 10 auricular points at one month intervals.
15797572|NCT04471155|Procedure|Holep|laser enucleation of the gland versus open enucleation
15797573|NCT04471142|Device|neuromuscular bandage|After the dressing is performed by the nursing team with a sterile gauze covering over the region of the healing points, the 7 cm wide Vitaltape® neuromuscular bandage will be applied. For the application of the bandage, maximum stretching will be performed over the region of the plastron and finished with the two ends, from two to three centimeters, without stretching. As many bundles of bandages as necessary will be applied according to the patient's body characteristics.
15797574|NCT04471129|Other|HFO/O2C/NIV|High-flow oxygen therapy + O2C + Non invasive ventilation
15797575|NCT04471129|Other|NIV/O2C/HFO|Non invasive ventilation + O2C + High-flow oxygen therapy
15797576|NCT04471116|Dietary Supplement|OMNi-BiOTiC® FLORA plus+|OMNi-BiOTiC® FLORA plus + is a dietary supplement for the treatment of a disturbed vaginal flora (dysbiosis). The product combines probiotic bacterial strains with a special fiber mixture. The product contains the following strains: Lactobacillus crispatus LBV88, Lactobacillus rhamnosus LBV96, Lactobacillus gasseri LBV150N and Lactobacillus jensenii LBV116
15797577|NCT04471103|Other|Participation in a Delphi survey|Participants will be asked to participate in an online Delphi survey (using one of two randomly allocated methods) to rate the importance of outcomes that should be measured to determine the effect of treatment for neonatal encephalopathy. Outcomes will be prioritised on their importance in a consensus-driven manner.
15797578|NCT04471077|Procedure|bariatric surgery|(Laparoscopic Sleeve Gastrectomy, laparoscopic Roux-en-Y gastric bypass)
15797579|NCT04471064|Drug|XY0206|Dosage form:Tablet;Multiple dose phase:Take the medicine once a day,1 tablet at a time.4 weeks of continuous medication is one course of treatment. After the first course of treatment, the subjects can continue to receive the experimental drug treatment until they meet the withdrawal criteria. The duration and interval of treatment were determined according to the accumulated condition after multiple dose.
15797582|NCT04471025|Procedure|USG guided infraclavicular block|USG guided infraclavicular block was applied to patients either by conventional two-person technique or by one person Jedi technique according to the allocated group. On Group I single operator controlled the probe with one hand while controlling the needle and the syringe on the other hand with the Jedi technique. The needle was held between the index finger and the middle phalanx of the middle finger, and the syringe was held with fingers 4 and 5, with the plunger part to the thumb in the palm. On Group II, operator used the probe and needle with different hands while an assistant controlling the syringe to aspirate or inject local anesthetic.
15797583|NCT04471012|Other|Individual counselling program|"An individual counseling program that was based on TM and included motivational interview techniques was given to the experimental group which involved general information about the importance of weight control, healthy diet, and exercise.
~Benefits of Healthy Diet and Physical Activity in PCOS Training Booklet was given during their first counseling session."
15797584|NCT04470999|Other|Leukapheresis|Blood collection and PBMC collection via apheresis machine will be conducted
15797585|NCT04470973|Drug|Cefuroxime|Patients receive cefuroxime as part of standard care.
15797586|NCT04470973|Drug|Amikacin|Patients receive amikacin as part of standard care.
15797587|NCT04470960|Behavioral|Training course for the community center health coordinators|"These community centers who have volunteered to join the project will receive a 12 week training session which includes the values and principles of health promotion and the principles of building a health promotion project.
~The participants will be requested to build a health promotion project within their community. Building and implementing the project will be assisted by a health promotion specialist. Each health promotion project will be evaluated according to the principles of health promotion."
15797588|NCT04470947|Diagnostic Test|Next generation functional drug screening|High-throughput image based in-vitro drug screening on primary patient tumor cells
15797589|NCT04470947|Diagnostic Test|Comprehensive genomic profiling|Comprehensive targeted profiling of genetic aberrations on primary patient tumor material
15797590|NCT04470934|Device|SeQuent® SCB drug-coated balloon catheter|"treatment of coronary artery disease with SeQuent® SCB of real world de-novo and restenotic lesions in native coronary arteries and coronary bypass grafts"
15797591|NCT04470921|Procedure|Opportunistic Salpingectomy|An opportunistic salpingectomy refers to removal of the fallopian tubes without the ovaries during (laparoscopic) interventions for benign (gynaecological) disease to reduce the number of ovarian cancer cases.
15797592|NCT04470908|Drug|Zanubrutinib|Single oral dose of 320 mg
15797593|NCT04470908|Drug|Rifabutin|Oral dose of 300 mg once daily
15797594|NCT04470895|Diagnostic Test|Failure Track patients analysis|"The nurse coordinator of the Fracture Track first comes to give the patient a written information note. She answers the patient's questions and obtains his or her non-opposition. The patient must be given sufficient time for reflection to make his decision in order to participate in the study. His non opposition will be traced in the computerized medical record. Each enrolling patient in the study can simultaneously participate in another research. There is no exclusion period in the protocol.
~Once the patient is included, a semi-directed interview is conducted. The name of the patient's usual pharmacy will be collected. Data from the computerised medical record concerning the patient's stay are also analysed.
~The patient's usual pharmacy or the nurse in charge of the patient will then be questioned in order to carry out a drug reconciliation interview."
15797598|NCT04470869|Other|Phone call|The relatives of both groups will be contacted by phone one month after the discharge of the ICU of the death, three month after, six month after and twelve month after. During these interviews the PTSD symptoms, the anxiety and depression symptoms, the complicated grief symptoms (in case of death) and the satisfaction about the ICU stay will be collected.
15797599|NCT04470856|Diagnostic Test|End-expiratory occlusion test (EEOT)|An occlusion manoeuvre during the end of expiration for 20 seconds
15797600|NCT04470843|Drug|Acetazolamide|Being that adequate pain control is essential to recovery in the post-operative setting, efforts have been made to address this pain at its root. Prior studies have demonstrated that preoperative administration of acetazolamide decreased post-operative referred pain in the immediate post-surgical period.
15797601|NCT04470843|Other|Placebo|Group 2 (placebo): Patients undergoing RALP with the peri-operative use of 10 mL normal saline as placebo.
15797602|NCT04470804|Drug|Sirolimus|Sirolimus treats in experimental group
15797603|NCT04470804|Drug|Cyclosporine A|Cyclosporine A uses for active comparator group.
15797604|NCT04470791|Biological|F(ab)2 antivenom therapy (antivipmyn®).|Antivipmyn is an equine origin antivenom produced by Institute Bioclon in Mexico (Silanes Laboratories, México). The snake venoms used to create the F(ab')2 fragments are from Crotalus durissus and Bothrops asper. The number of doses of each patient depended on the classification and evolution, as indicated by the manufacturer for grade II envenoming: from 6 to 10 bottles of F(ab)2 antivenom therapy, intravenously, as an initial dose. One dose (bottle) consisted of 10 mL of polyvalent concentrated and modified horse antibodies treated by enzymatic digestion to neutralize the Bothrops asper venom to not less than 780 lethal dose 50 (LD50), and the Crotalus basiliscus venom to not less than 790 LD50.
15797605|NCT04470791|Procedure|Local cryotherapy.|Interval cryotherapy consisted of applying a plastic bag (the size of the bag depending on the size of the lesion, approximately 28 x 46 cm) two-thirds filled with crushed ice (frapped) wrapped in a towel applied for 20 minutes every 4 hours at the site of the snakebite throughout the hospital stay. New ice bags were used after 4 hours.
15797606|NCT04470778|Drug|BMS-986256|Specified dose on specified days
15797607|NCT04470778|Drug|Famotidine|Specified dose on specified days
15797608|NCT04470765|Device|Zida|Transcutaneous Tibial Nerve Stimulation
15797609|NCT04470752|Drug|Capsaicin 1% oral solution|Capsaicin 1.0 micrograms/ml
15797610|NCT04470752|Drug|InOrpha Solution|glycerol based suspension vehicle
15797611|NCT04470739|Diagnostic Test|chest x-ray|First Chest X-ray in the first 6 hours of infants
15797612|NCT04470726|Drug|AIV001|Intradermal/intratumoral
15797613|NCT04470687|Device|contrast enhanced ultrafast ultrasound imaging|"Ultrasound contrast medium: SonoVue 8µL/mL (Bracco International BV) Ultrasound scanner: Aixplorer® device marketed by SuperSonic Imagine©, CE Doppler UltraFast™Doppler, contrast ultrasound (CEUS), color Doppler and ultra-sensitive energy Doppler, high-performance directional energy Doppler, Elastography ShearWave™ UF-Doppler (UltraFast-Doppler) and microbubble injection (SonoVue) Apparatus for performing the UF Doppler sequence: Aixplorer, manufacturer : Supersonic Imagine, Aix-en-Provence, France, CE Marking.
~3D RCA dedicated vascular probe with dedicated Doppler sequences"
15797614|NCT04470674|Drug|Durvalumab|Durvalumab 1500 mg
15797615|NCT04470674|Drug|Carboplatin|carboplatin AUC 5
15797616|NCT04470674|Drug|Pemetrexed|pemetrexed 500 mg/m2
15797617|NCT04470661|Diagnostic Test|Ultrasonography|"Point-of-care ultrasound:
~Kidney length and echogenity,
~Bladder scanning
~VCI measures
~Lung B lines and effusion
~Cardiac measurements; EF, TAPSE, TR Vmax, Diameters, LV filling pressures"
15797618|NCT04470648|Diagnostic Test|blood test for SARS-COV2 serology|each person who will accept to participate will have a bood test for a SARS-COV2 serology
15797619|NCT04470635|Diagnostic Test|ELISA|Saliva sample collection
15797622|NCT04470609|Biological|Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule|Two doses of low dosage(50U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28
15797623|NCT04470609|Biological|Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule|Two doses of medium dosage(100U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28
15797624|NCT04470609|Biological|High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule|Two doses of high dosage(150U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28
15797625|NCT04470609|Biological|Placebo on a 0- and 28-day schedule|Two doses of placebo at the vaccination schedule of day 0,28
15797626|NCT04470570|Other|Cross-Education|1) Cross-Education: The effect that exercising the uninvolved upper extremity will have a positive effect on the involved upper extremity.
15797627|NCT04470570|Other|Blood-Flow Restriction Training|1) Blood Flow Restriction: A type of resistance training using a blood-pressure like cuff that partially occludes venous blood flow to induce various neurohormonal effects and allows strength gains to be achieved at very low loads of resistance.
15797628|NCT04470557|Diagnostic Test|D-dimer,CBC.ESR,CRP,|Complete blood count (for patients and control subjects): was done on CELL-DYN 3700 (Abbott-Germany) and blood film was stained by leishman staining, the morphology of red blood cells. CRP titre estimation by latix method .ESR erythrocyte sedimentation rate estimation (1:5) by Westerngreen tube method.
15797629|NCT04470557|Diagnostic Test|Liver function tests ,serum ferritin and PCR for COVID-19 .|"Serum ferritin was performed for all subjects on Modular P auto analyzer (Roche Diagnostics, Mannheim, Germany),
~• Liver function tests ( aspartate aminotransferase, alanine aminotransferase and alkaline phosphatase) and kidney funcrion were performed for all subjects on Modular P auto analyzer (Roche Diagnostics, Mannheim, G ermany),"
15797630|NCT04470544|Drug|Camostat Mesilate|Given PO
15797631|NCT04470544|Other|Standard of Care|At Investigator discretion
15797632|NCT04470531|Drug|oral co-trimoxazole|oral co-trimoxazole + standard therapy
15797633|NCT04470518|Other|diagnostic algorithm|"Guidance will be part of a diagnostic algorithm which includes clinically guided point-of-care C-reactive protein testing and safety netting advice to inform parents on what to expect and what to look out for. A selection of clinical features will be assessed and recorded by the physician in the patient's health record and on the e-CRF, including the clinical decision tree (clinician's gut feeling, body temperature, dyspnea).
~The safety-netting advice will be supported by a parent information booklet, based on previous research (the When should I worry-interactive booklet (a guide to Coughs, Colds, Earache & Sore Throats), the Mijn kind heeft koorts booklet (Eefje de Bont, www.thuisarts.nl), and the Caring for children with coughs-leaflet (information about how to look after a child who has a cough and when to see the doctor))."
15797634|NCT04470492|Combination Product|Doctormate®+Medical Management|Patients will be treated with Renqiao Remote Ischemic Conditioning Device (Doctormate®) (200mmHg) twice daily and conventional medication for 3 months.
15797635|NCT04470492|Drug|Medical Management|Patients will be treated with conventional medication for 3 months.
15797636|NCT04470479|Drug|Pilocarpine Hydrochloride|Oral pilocarpine hydrochloride 5mg tablets were administered four times a day for 10 weeks to half the group of selected patients. The other half ingested placebo in the same way. At the end of this period and after two weeks of washing out the medications, the patients had to invert the treatments.
15797637|NCT04470479|Drug|Placebo|Placebo
15797638|NCT04470466|Device|short pulse and Q-switched ND-YAG laser with topical carbon|application of topical carbon cream, followed by two passes of short pulse 1064 ND-YAG, then one pass of Q-switched 1064 ND-YAG on one side of the face
15797639|NCT04470466|Device|fractional CO2 laser|single pass of fractional CO2 laser on the other side of the face
15797640|NCT04470453|Biological|Blood sample|Blood samples will be collected for measuring PG-MTX blood concentration.
15797641|NCT04470453|Diagnostic Test|CRQ|Compliance Rheumatology Questionnaire (CQR) is a self-administered questionnaire for to evaluate therapeutic observance during rheumatoid arthritis.
15797642|NCT04470427|Biological|mRNA-1273|Sterile liquid for injection
15797644|NCT04470414|Diagnostic Test|IgG antibodies immunoassay|Assessment of IgG level will be done by quantitative assessment of IgG in the serum of recovered persons by Chemiluminescence Immunoassay (CLIA).
15797645|NCT04470401|Drug|AbobotulinumtoxinA|application of 1cc of placebo (saline) or 1cc of abobotulinumtoxinA in both subscapularis and pectoral major muscles
15797646|NCT04470401|Drug|Saline|application of 1cc of placebo (saline) or 1cc of abobotulinumtoxinA in both subscapularis and pectoral major muscles
15797647|NCT04470388|Drug|EDP-514|Oral Capsule
15797648|NCT04470388|Drug|Placebo|Placebo to match EDP-514
15797649|NCT04470375|Behavioral|Virtual Reality Pain Neuroscience Education|Use of virtual reality media to provide pain neuroscience education
15797650|NCT04470362|Device|Isokinetic dynamometer|an isokinetic strengthening program for the quadriceps muscles. Twenty-four strengthening session will be performed using an isokinetic device. The exercise program begins with 60% of the mean peak torque, and the patient reaches this intensity by auditory biofeedback. An increasing dose program will be used in the first 5 sessions (1 set to 5 sets), and a dose of 6 sets will be applied from the sixth to twenty-fourth sessions, with the density rising from 60% to 80% of the mean peak torque according to the patient tolerance. Each set consisted of 5 repetitions of concentric (Con/Ecc) contraction in angular velocities of 30°/second and 120°/second for extensors. This program accomplished significant results in increasing the quadriceps power and strength.
15797651|NCT04470349|Device|LITOS|Patients who received a LITOS dynamic distraction system after 31.12.2017
15797652|NCT04470349|Device|Ligamentotaxor|Patients who received a Ligamentotaxor dynamic distraction system after 31.12.2017
15797653|NCT04470336|Other|Collagen Supplement|Three capsules post-breakfast Three capsules post-dinner
15797654|NCT04470336|Other|Glucosamine chondroitin|Three capsules post-breakfast Three capsules post-dinner
15797655|NCT04470336|Other|Placebo|Three capsules post-breakfast Three capsules post-dinner
15797656|NCT04470323|Diagnostic Test|Flow cytometry|Lymphocyte subsets in peripheral blood were assessed by staining 50 µl of blood sample with 5 µl of Fluoroisothiocyanate (FITC)-conjugated- PD-1, phycoerythrin (PE)-conjugated-CD8, peridinium-chlorophyll-protein (Per-CP)-conjugated-CD4, Peridinium-chlorophyll-protein (Per-CP)-conjugated anti-CD3 and allophycocyanin (APC) conjugated anti-CD28.
15797657|NCT04470310|Drug|Glimepiride|
15797658|NCT04470310|Drug|Alogliptin 25Mg Tab|
15797659|NCT04470310|Drug|Alogliptin-Pioglitazone 25 Mg-15 Mg Oral Tablet|
15797660|NCT04470297|Drug|Ramelteon 8mg|Standard care combined with oral placebo or ramelteon 8mg at bedtime for 10 days
15797661|NCT04470284|Other|Mobile Application|SMBP with mobile App based feed-back algorithm. The App based feed-back algorithm will remind the patients of taking drug to improve BP control and drug compliance.
15797662|NCT04470284|Other|Standard SMBP|Standard treatment
15797663|NCT04470271|Other|Patients with hepatitis C lost follow up|Patients with chronic HCV who were lost of follow up will be contacted by phone or email. At least 3 phone calls will be made on three different days. In case the patient is not contacted it will be considered lost of follow-up
15797664|NCT04470258|Other|ELMO PROJECT AT COVID-19: STUDY IN HUMANS|The Elmo system will be applied to 10 patients with hypoxemic respiratory failure by COVID-19 and its effectiveness will be assessed by analyzing the physiological variables and the patient's comfort, as well as their clinical outcomes (need for tracheal intubation) and recovery time. Hypoxemic respiratory failure and need for O2.
15797665|NCT04470258|Device|ELMO PROJECT AT COVID-19: PROOF OF CONCEPT AND USABILITY|After testing for the following requirements: offering CPAP, ensuring the maintenance of alveolar ventilation without CO2 rebreathing, monitoring intra-ELMO pressure, minimizing adverse effects of the system such as noise, face temperature, airway dryness and comfort global; tests will be carried out on healthy volunteers using prototypes of the Elmo system and assessing whether their effectiveness in providing positive airway pressure and their usability from the perspective of their primary users (doctor, physiotherapist and nurses) and the volunteer's comfort . With this, realistic simulations will be carried out, centered on the evaluation based on heuristic principles.
15797666|NCT04470245|Diagnostic Test|magnetic resonance imaging (MRI)|Our study will include healthy volunteers (to refine the scanning sequence) and patients undergoing surgery for CTS. Patients will be scanned before and after their operation using cutting-edge diffusion MRI techniques.
15797667|NCT04470232|Other|Self-assessment questionnaires|"120 patients with coxofemoral pathologies will pass the SUSHI-score and the HOOS-12 score questionnaires.
~The HAGOS (Hip and Groin Score) questionnaire will be also passed by the subject, for the convergent validity."
15797668|NCT04470219|Other|Cognitive support by RemindMe|
15797669|NCT04470193|Other|MyChildCMC app|Patients/parents will self-monitor their symptoms daily using the MyChildCMC app completing the daily vitals form. After patient/parents complete the daily form, the app provides in-app alerts and graphs showing symptom data over time.
15797670|NCT04470180|Behavioral|Virtual Teach to Goal|Participants will complete inhaler education on a tablet device.
15797671|NCT04470180|Behavioral|Brief Instruction|Participants will be read out loud instruction on how to use their inhaler.
15797672|NCT04470167|Biological|TPX-115|Ultrasound-guided intratendinous injection of allogeneic fibroblasts(TPX-115)
15797673|NCT04470167|Other|Placebo|Ultrasound-guided intratendinous placebo injection
15797674|NCT04470154|Drug|HSK21542 0.05 μg/kg,0.15 μg/kg,0.30 μg/kg,0.80 μg/kg|Following the principle of dose escalation and starting from the low dose of 0.05 μg/kg to the high dose 0.80 μg/kg
15797675|NCT04470154|Drug|Placebo 0.05 μg/kg,0.15 μg/kg,0.30 μg/kg,0.80 μg/kg|Following the principle of dose escalation and starting from the low dose of 0.05 μg/kg to the high dose 0.80 μg/kg
15797676|NCT04470154|Drug|HSK21542 0.3 μg/kg,0.6 μg/kg|HSK21542 dose 0.3 μg/kg or 0.6 μg/kg
15797677|NCT04470154|Drug|Placebo 0.3 μg/kg,0.6 μg/kg|Placebo dose 0.3 μg/kg or 0.6 μg/kg
15797678|NCT04470141|Drug|SHC014748M treatment|Each treatment cycle is comprised of 28-day consecutive dosing of SHC014748M, 200mg QD (Days 1 to28). Upon completion of each cycle, patients may continue to receive oral SHC014748M if they can benefit from the treatment and the toxicity is tolerable.
15797679|NCT04470128|Drug|Stage I: HSK21542 0.5 μg/kg|After the completion of the administration of study drug (2, 15, and 30 min), propofol is initially intravenously injected at 0.3 mg/kg
15798369|NCT04464759|Drug|Ipilimumab|Combination of nivolumab, hydroxychloroquine and ipilimumab
15797680|NCT04470128|Drug|Stage I: HSK21542 1 μg/kg|After the completion of the administration of study drug (2, 15, and 30 min), propofol is initially intravenously injected at 0.3 mg/kg
15797681|NCT04470128|Drug|HSK21542 0.5 μg/kg|The dose and time of administration of the investigational product will be adjusted appropriately based on the results of stage I, with corresponding protocol amendments.
15797682|NCT04470128|Drug|HSK21542 1 μg/kg|The dose and time of administration of the investigational product will be adjusted appropriately based on the results of stage I, with corresponding protocol amendments.
15797683|NCT04470128|Drug|fentanyl 1 μg/kg|The dose and time of administration of the investigational product will be adjusted appropriately based on the results of stage I, with corresponding protocol amendments.
15797684|NCT04470115|Other|General anesthesia|Patients will receive general endotracheal anesthesia with typical drugs used (propofol, fentanyl, sevoflurane). the exact dose of the drug will be on the discretion of anesthesia provider, according to good clinical practice.
15797685|NCT04470115|Other|Regional anesthesia- femoral and lateral femoral cutaneous nerve blocks|The femoral nerve (FN) is identified with ultrasound. The needle is inserted in-plane, from lateral to medial. We administer 15 to 17ml of local anesthetic (0.5 to 0.75% ropivacaine). After good anesthetic spread on FN we identify lateral femoral cutaneous nerve (LFCN) in its expected location 2-3 cm below inguinal ligament, laterally to sartorius muscle and inject usually 4 to 5 ml of local anesthetic. Oxygen 2-3 l/min is given via face mask to maintain Sp02 and the block is followed by sedation. Sedation is achieved with boluses of propofol to enable procedure and maintain patient in comfort. We aim to keep the depth of sedation at Ramsay sedation scale of 4. Whether it is possible we use loud verbal stimulus, if it is not we use gently glabella tap to assess depth of sedation. Patient is breathing spontaneously during the whole surgery. After surgical field is prepared, surgeon infiltrates expected entry points of intramedullary nail system with 0,5% lidocaine.
15797686|NCT04470102|Procedure|mitral valve repair by edge-to-edge technique|transaortic access for mitral valve repair edge-to-edge
15797687|NCT04470102|Procedure|Septal myectomy|isolated extended septal myectomy
15797688|NCT04470089|Drug|Myramistin|Oromucosal application
15797689|NCT04470076|Drug|Neoadjuvant treatment: Afatinib, pemetrexed, gemcitabine, cisplatin, carboplatin|"① Eligible patients with non-squamous cell lung cancer will receive pemetrexed 500mg/m2, IV on day 1 and cisplatin 75mg/m2 or carboplatin area under curve (AUC) =5, on day 1 of a 3-week schedule for 3 cycles.
~② Eligible patients with squamous cell lung cancer will receive gemcitabine 1250mg/m2 IV on day 1 and day 8, and cisplatin 75mg/m2 or carboplatin AUC =5 on day 1 of a 3-week schedule for 3 cycles .
~③Patient will take afatinib at dosage of 30mg per day 48 hours after chemotherapy and will stop 24 hours before next cycle of chemotherapy."
15797690|NCT04470076|Procedure|Surgical treatment|The patients who respond to neoadjuvant treatment (CR+PR) and the patients who do not respond to therapy but could still undergo surgery (SD and PD) will receive radical lung resection 3-4 weeks later after neoadjuvant.
15797691|NCT04470076|Drug|Adjuvant treatment:afatinib|The CR, PR and SD patients who have been treated surgically will take afatinib at a dosage of 30mg per day for 2 year.
15797694|NCT04470050|Drug|Sublingual film containing Dexmedetomidine (BXCL501)|Sublingual film containing Dexmedetomidine (BXCL501)
15797695|NCT04470050|Drug|Placebo film for BXCL501|Placebo film for BXCL501
15797696|NCT04470037|Drug|DAAOI-P|DAAOI-P 250-1500mg
15797697|NCT04470037|Drug|Placebo|starch pill
15797698|NCT04470024|Drug|INCAGN01876|agonistic antihuman GITR mAb
15797699|NCT04470024|Drug|INCMGA00012|humanized, hinge-stabilized, IgG4κ mAb that recognized human PD-1
15797700|NCT04470024|Biological|DPV-001|autophagosome cancer vaccine
15797701|NCT04470011|Other|Routine medical record data collection|The study will collect routine medical record data from the electronic medical record system, other electronic databases, and paper charts.
15797702|NCT04470011|Other|Interviews with service providers|Clinicians and lay staff will be interviewed regarding the ART initiation process.
15797703|NCT04469998|Drug|AXR-270 Low Dose|AXR-270 Topical Eyelid Cream
15797704|NCT04469998|Drug|AXR-270 High Dose|AXR-270 Topical Eyelid Cream
15797705|NCT04469998|Drug|AXR-270 Vehicle|AXR-270 Topical Eyelid Cream Vehicle
15797706|NCT04469972|Other|Breathing Exercises|Breathing exercise is defined as therapeutic intervention to create a particular form of breathing.The application of the breathing exercise program is as follows; I. Pursed Lip Breathing Exercise (Total 10 minutes) II. Diaphragmatic breathing exercise (10 minutes in total), III. Cough exercise (Total 10 minutes)
15797707|NCT04469959|Drug|L-Dopa|"Generic 25/100mg carbidopa/levodopa (Sinemet)tablets will be administered in this study. Participants will begin randomized double blinded 3- week trial of Levodopa. Dose titration starting at150 mg /daily to maximum of 450 mg patch/daily three times a day for three weeks.
~After one week of taper they will enter step 2 phase of study where carbidopa/levodopa matched placebo will be administered for 3 weeks afterwards dose will be slowly tapered over next 7 days."
15797708|NCT04469959|Drug|Placebo|Step 1(3weeks) Carbidopa/levodopa-matched placebo tablet 3 times. Followed by 1 week of taper Step2(3 weeks):150-450mg carbidopa/levodopa 3 times daily for three weeks .Followed by 1 week of taper.
15797709|NCT04469946|Device|Oticon OpenSound Navigator speech enhancement algorithm|OpenSound Navigator (OSN) is a speech enhancement algorithm developed by Oticon. The feature is built in Oticon's current OPN™ hearing aid platform and can be adjusted and disabled in the programming. It is designed to automatically enhance speech while reducing unwanted background noise to improve communication for the user.
15797710|NCT04469920|Drug|Saroglitazar Magnesium 2 mg|1 tablet, single dose at Day 1
15797711|NCT04469920|Drug|Saroglitazar Magnesium 4 mg|1 tablet, single dose at Day 1
15797712|NCT04469907|Drug|AZD9977|Participants will receive a single oral dose of AZD9977 under fasted conditions.
15797713|NCT04469881|Behavioral|VR|"Participants will be asked to do the following things:
~Wear VR goggles for the duration of the surgery
~Answer questions about their experience with the VR goggles
~Give permission for the researchers to collect information about the anesthesia medications used, pain medications used, and reported pain scores during the surgery and during recovery in the hospital"
15798133|NCT04466605|Other|Primary care|Patients will follow standard care provided by primary care physicians including analgesics and self care management.
15797714|NCT04469868|Behavioral|No opioids at discharge|"Patients who are being scheduled for any major urologic cancer surgery (open or laparoscopic) will be counselled regarding post-operative pain and measures taken during surgery and during hospital stay.
~They will be provided written information on these pain mitigation efforts and the adverse effects associated with opioids use and outpatient prescriptions.
~Patients will be discharged from the hospital without any opioids prescriptions and instructions to use non-opioids analgesics.
~Patients will complete a visual analog pain scale daily for 7 days after discharge from the hospital.
~Patients will be able to call the clinic at anytime for any post-operative pain issues."
15797715|NCT04469855|Drug|semaglutide|Patients will be treated with commercially available Ozempic® according to routine clinical practice at the discretion of the treating physician. The treating physician's decision to initiate treatment with Ozempic® is independent of the decision to include the patient in the study.
15797716|NCT04469842|Drug|Tacrolimus Extended Release Oral Tablet [Envarsus]|Immunosuppression regimen with Tacrolimus Extended Release as the backbone.
15797717|NCT04469842|Drug|Tacrolimus|Standard Immunosuppression regimen with Intermediate-Release Tacrolimus.
15797718|NCT04469842|Drug|Mycophenolate Mofetil Hydrochloride|Standard immunosuppression of the anti-proliferative class.
15797719|NCT04469842|Drug|Prednisone|Standard immunosuppression (corticosteroid class).
15797720|NCT04469842|Drug|Azathioprine|Standard immunosuppression of the anti-proliferative class.
15797721|NCT04469829|Drug|Secukinumab|standard doses of secukinumab for psoriasis
15797722|NCT04469829|Drug|Methotrexate|Methotrexate 15 mg/week
15797723|NCT04469816|Behavioral|Family Check-Up 4 Health|A parent-training intervention to improve child health, school readiness and manage obesity.
15797724|NCT04469816|Other|Services as Usual|Services/Treatment as usual.
15797725|NCT04469803|Behavioral|Intra-Shift Napping|The Brief Nap opportunity will allow for a 30-minute nap between the hours of 0200 and 0400 during the 12-hour simulated night shift. The Longer Nap opportunity will allow for a 2-hour nap between the hours of 0200 and 0400 during the 12-hour simulated night shift.
15797726|NCT04469790|Behavioral|SIT+WALK|Participants will interrupt their sitting for one week
15797727|NCT04469790|Behavioral|EX|Participants will perform a single bout of exercise and then sit for the remaining time for one week
15797728|NCT04469777|Drug|erythropoietin|Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days).
15797732|NCT04469751|Diagnostic Test|invasive blood pressure monitoring|radial artery and dorsalis pedis artery intubated with BD Insyte-W 22G artery puncture needle under local anaesthesia
15797733|NCT04469738|Device|SCS is switched off|Spinal cord stimulator is switched off for 12 hours
15797734|NCT04469738|Device|SCS is switched on|Spinal cord stimulator is functioning
15797735|NCT04469725|Drug|KN046|KN046 5 milligram per kilogram, every 2 weeks
15797736|NCT04469712|Procedure|SASI Bipartition|SASI Bipartition is performed with a sleeve gastrectomy over a 32 French gastric bougie and a 300 cm common limb. Side-to-side gastroileostomy with a diameter of approximately 2.5 cm at the anterior part of antrum, 6 cm proximal to pylorus.
15797737|NCT04469712|Procedure|Gastric bypass|A small gastric pouch (15 mL) is created, and the jejunum brought up as an antecolic and antegastric fashion. Routine limb lengths were 150 cm for the alimentary limb and 60 cm for the bilio-pancreatic limb. Both mesenteric defects are closed with the Endohernia® stapler.
15797738|NCT04469699|Drug|Stereotactic biopsy followed by stereotactical photodynamic therapy with 5-aminolevulinic acid|5-ALA HCl orally (20 mg/kg bw) 3,5-4,5 hours prior to induction of anaesthesia for stereotactic biopsy followed by stereotactical photodynamic therapy. All patients will receive further treatment of recurrent glioblastoma at the investigator´s discretion (best possible care).
15797739|NCT04469699|Procedure|Stereotactic biopsy|Stereotactic biopsy. All patients will receive further treatment of recurrent glioblastoma at the investigator´s discretion (best possible care).
15797740|NCT04469686|Combination Product|Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator|Twice daily 90 mg hydrocortisone acetate suppository administered with Sephure applicator
15797741|NCT04469686|Combination Product|Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator|Once daily 90 mg hydrocortisone acetate or placebo suppository administered with Sephure applicator
15797742|NCT04469686|Combination Product|Twice daily placebo suppository administered with Sephure applicator|Twice daily placebo suppository administered with Sephure applicator
15797743|NCT04469673|Biological|Biological：JS002|Administered by subcutaneous injection
15797744|NCT04469673|Biological|Placebo|Administered by subcutaneous injection
15797745|NCT04469647|Diagnostic Test|Serology Test|"Participants will be seen at T0 (baseline),T2 (2 months after T0), and T4 (2 months after T2).
~at every visit, participants will be asked to complete a general surveillance survey and a blood sample will be taken for the serology test."
15797746|NCT04469634|Diagnostic Test|Assessing antibody responses, neutralizing capacity and memory B-cell function|Assessing antibody responses, neutralizing capacity and memory B-cell function and their contribution to protection against re-infection
15797747|NCT04469621|Drug|SAR443122|Pharmaceutical form:capsule Route of administration: oral
15797748|NCT04469621|Drug|Placebo|Pharmaceutical form:capsule Route of administration: oral
15797749|NCT04469608|Behavioral|acupuncture|Traditional Chinese medicine clinical daycare
15797750|NCT04469595|Drug|Iluvien 0.19 MG Drug Implant|0.19 mg Fluocinolone Acetonide Intravitreal Implant
15797751|NCT04469595|Drug|Aflibercept|2 mg/0.05 mL Aflibercept Anti-VEGF intravitreal injection
15797806|NCT04469127|Drug|AIP-303|Study participants be administered therapeutic doses of AIP-303 up to four treatments spaced 8 weeks apart and a CT scan immediately after. An AIP 301 Ga-68 PET/CT scan will be performed four weeks before and four weeks after the initial dose of the AIP-303.
15797807|NCT04469114|Drug|Tofacitinib 10 mg|Tofacitinib 10mg administered orally twice daily for 14 days or until hospital discharge
15797808|NCT04469114|Drug|Placebo|Tofacitinib-matching placebo administered orally twice daily for 14 days or until hospital discharge
15797752|NCT04469569|Behavioral|HPV-PROTECT|HPV-PROTECT is a multicomponent provider-focused intervention specifically tailored for use in pediatric oncology settings, addressing important survivor-specific vaccine issues. The intervention is comprised of three components, i) Provider Communication Training; ii) Assessment and Peer Feedback/ Coaching; and iii) Provider Toolkit. The HPV-PROTECT intervention is designed to increase provider knowledge regarding use of the HPV vaccine in the cancer survivor population, enhance provider skills in delivering brief, compelling HPV vaccine recommendations to parents of young cancer survivors, present ongoing feedback to providers regarding clinic- and provider-level survivor HPV vaccination rates, and decrease barriers to receipt of vaccine by survivors through the provision of Vaccine Action Plans, tailored to local context.
15797753|NCT04469556|Drug|Folfirinox|Chemotherapy
15797754|NCT04469556|Drug|Gemcitabine/nab-paclitaxel|Chemotherapy
15797755|NCT04469530|Drug|SIROLIMUS|Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus. Dose of 2 mg/m2 once daily. The amber oral dose syringe should be used to withdraw the prescribed amount of sirolimus oral solution from the bottle. The solution can be drunk or administered at once to assure delivery of all of the medication. It is safe for administration through a nasogastric or G-tube. For tablets, the tablet should not be crushed, split, or otherwise altered. As with the liquid dosing form, the tablets should be given within two hours each day and should be at consistent intervals with regard to meals.
15797756|NCT04469530|Drug|Cyclophosphamide|"A synthetic antineoplastic drug chemically related to the nitrogen mustards. The drug is administered orally daily, in the formulation appropriate for age.
~The solution should be diluted in 20-30 ml of appropriate liquid before administration through NG tube or G tube, with adequate flushing after administration to prevent obstruction of the feeding tube."
15797757|NCT04469530|Drug|VP-16|A semisynthetic derivative of podophyllotoxin which functions as mitotic inhibitor but does not interfere with microtubular assembly. The drug is administered orally daily, in the formulation appropriate for age.
15797758|NCT04469530|Drug|Celecoxib|The empirical formula for celecoxib is C 17 H 14 F 3 N 3 O 2 S. The drug is administered orally daily, in the formulation appropriate for age.The solution is safe for administration through a nasogastric or G-tube.
15797759|NCT04469517|Other|hypoxic induced factors|hypoxic induced factors analyzed in blood sample
15797760|NCT04469504|Other|Prehabilitation program|4-week trimodal prehabilitation program: Exercise, nutritional supplementation, and psychological support
15797761|NCT04469504|Dietary Supplement|Oral Impact|perioperative immunonutrition by ORAL IMPACT
15797762|NCT04469491|Drug|inhaled type I interferon|The interventional arm includes inhaled interferon (9.6 MUI x2/d for 48 hours, then 9.6 MUI x1/d for 8 to 16 days or discharge), in addition to standard care. In phase B, maximum treatment duration is 8 days.
15797763|NCT04469491|Drug|WFI water nebulization|The interventional arm includes a WFI water nebulization comparator.
15797764|NCT04469478|Other|Survey and interview|Patients and caregivers will provide information via surveys and interviews regarding their experience viewing diagnostic imaging using conventional methods and using Virtual Reality
15797765|NCT04469465|Drug|Danicopan|Oral tablet
15797766|NCT04469465|Drug|Placebo|Oral tablet
15797767|NCT04469465|Drug|C5 Inhibitor|Participants will continue to receive their ongoing C5 inhibitor (eculizumab or ravulizumab) therapy according to their usual dose and schedule.
15797768|NCT04469452|Device|Apollo Device|Comparisons will be made between the Apollo EE Device (Sable Systems International, Las Vegas, NV) and the TrueOne 2400 metabolic cart (Parvo Medics, Salt Lake City, UT)
15797769|NCT04469426|Other|Interactive online informational and peer support app|The app contains LARS information, bowel function diaries, and online platform with trained peer support mentor
15797770|NCT04469413|Drug|Paracetamol Infusion|Continuous and Standard Intermittent Boluses Paracetamol Infusion
15797771|NCT04469400|Dietary Supplement|Low fat diet intensive intervention|education and Compound protein solid beverage
15797772|NCT04469400|Other|Low-Carbon Water Diet Intensive Intervention|education and Nutrition bar
15797773|NCT04469387|Procedure|Limited decompressions at adjacent segment with asymptomatic pre-existing spinal canal stenosis|In terms of limited decompression at the adjacent segment, partial laminotomy, flavectomy, and bilateral medial facetectomies up to the pedicle will be performed. Complete laminectomy and destroy of posterior ligament complex will be avoided.
15797774|NCT04469387|Procedure|Responsible segments fused|In terms of responsible segments fused, L4-5 and L5-S1 were fused using posterior lumbar interbody fusion (PLIF).
15797775|NCT04469374|Other|Jumping exercise|Participants will be required to perform 10 maximal vertical jumps, with a 10-s rest interval between each jump, using an arm swing in countermovement style on three days per week. The jumps will be performed without shoes on a hard surface. The jumps will be preceded by a warm-up lasting approximately 3 min and consisting of mobilisation exercises for the legs and lower back. Jumping will be progressed over time and in accordance with individual needs.
15797776|NCT04469374|Other|Balance exercise (sham control)|Participants will be required to perform balance exercises. Participants will be required to balance on one leg for up to 60 seconds (2 x 60 s is equivalent in duration to the 10 jumps). This exercise will be progressed.
15797777|NCT04469361|Other|Navicular drop measurement|The difference in navicular height between sitting and standing positions was recorded (mm) as the amount of navicular drop.
15797778|NCT04469361|Other|Measurement of venous return parameters in supine|Venous return parameters of posterior tibial vein was measured when participant applied force equivalent to their own body weight on plantar surface of their right leg in supine position
15797779|NCT04469361|Other|Measurement of venous return parameters in standing|In standing, venous return parameters was measured of posterior tibial vein when participants shift all of their weight to the right leg for 3 second with their leg muscles as relaxed as possible and their knee joint in full extension.
15797780|NCT04469361|Other|measurement of midfoot pressure distrubition|In standing, midfoot pressure distrubution was measured when participants shift all of their weight to the right leg
15797781|NCT04469348|Diagnostic Test|nasal swab|nasal swab will be performed to analysis biological markers at every visit.
15797866|NCT04468750|Device|kinesiotape|During the rehabilitation program, all patients with GHS had kinesiotaping three times a week.
15797867|NCT04468737|Behavioral|Bowel preparation|Observe patients who undergo bowel preparation by enema or irrigation
15797782|NCT04469335|Device|mobile neurofeedback|"to maximize usability and effectiveness, we would like to conduct a study that regulates theta/beta ratio using mobile app-based Neurofeedback Training Equipment (OmniCNS).
~The actual Neurofeedback training allows you to download and use the omnifit brain_Game, an application with an audio guide. After the pre-assessment, the researcher will provide guidance to subjects and carers on how to use the application, and demonstrate how to use it in practice. For 2 weeks, 4 weeks and 6 weeks, phone calls are conducted to check whether they are used or not and for any inconvenience. After 12 weeks of Neurofeedback training, the device is returned and post-evaluated.
~The application is equipped with four types of games and is instructed to use the three-day-a-week application. For Neurofeedback attention and cognitive training, use a headset with left and right frontal lobe 2 channel-EEG sensors to perform the game through feedback to see if it is concentrating well."
15797783|NCT04469335|Device|Sham mobile neurofeedback|"It uses the sham devices and programs as the Neurofeedback, but it is not usually possible to obtain the expected effects of the Neurofeedback by providing random feedback regardless of actual brain waves.
~In case of Sham control group, parental education is conducted the same for each clinical evaluation, and in case of Sham control group, actual Neurofeedback is applied if patients and parents want it after the end of the study."
15797784|NCT04469335|Device|medication + mobile neurofeedback|The mobile needback is applied to patients who are taking methylphenidate or atomoxetine, which is a standard ADHD treatment, but have not been remissioned with more than 4 points of CGI-S.
15797785|NCT04469335|Device|medication + Sham mobile neurofeedback|The sham mobile needback is applied to patients who are taking methylphenidate or atomoxetine, which is a standard ADHD treatment, but have not been remissioned with more than 4 points of CGI-S.
15797786|NCT04469322|Diagnostic Test|Mental Health DNA Insight Test (Pathway Genomics)|Pharmacogenetic report based on the patients DNA profile at ~45 SNP markers covering 16 genes
15797787|NCT04469322|Diagnostic Test|Sham Test|"Names of 53 medications listed with use as directed"
15797788|NCT04469309|Other|Group I Brandt-Daroff Exercises|"In group I Brandoff Exercises will be performed using standard method, in which the patient is in the sitting position on examination table, the patient moves into the lying position on the affected side on the shoulder, with the head angled upward with about 45. The patient stays in this for 30 s and then goes back to the sitting position, looks forward and remains in this position for 30 s as well. The patient repeats the same procedure for the other side, too.
~The patient performs this maneuver 2 times, twice a day. For total 9 days for 3 weeks. Pre, mid and post assessment."
15797789|NCT04469309|Other|Group II Half-Somersault Maneuver|In group II Half-Somersault Maneuver will be done, the patient performs this maneuver 2 times, twice a day. For total 9 days for 3 weeks.
15797790|NCT04469296|Dietary Supplement|iso-caloric ketogenic diet|Each patient will be offered a daily diet plan that includes the different groups of low glycemic index foods to bring to each meal and snack, with the notion of quantity. Carbohydrate-free foods can be consumed ad libitum. Dietary advice will be given to increase the consumption of lipid foods (vegetable oils, butter, cheeses, fatty fish, etc.) so that 65% of the total energy intake is provided by lipids. In addition, a list of unauthorized sugars and sweeteners substitutes will be proposed as well as a low glycemic index food composition table centered on carbohydrates for better control of food choice
15797791|NCT04469296|Dietary Supplement|protein restricted diet|A diet reducing by 20% the amount of protein compared to the usual intake of the patient will be proposed. This new ration will be carried out by calculating the proportion of total energy intake provided by the amount of protein reduced by 20% compared to the usual intake, and by modifying lipid and carbohydrate intakes to obtain an isocaloric ration.
15797792|NCT04469283|Other|caffeine and movement disorders|Caffeine efficacy on movement disorders in patients with ADCY5-related dyskinesia.
15797793|NCT04469270|Biological|Engensis|Intramuscular injections
15797794|NCT04469270|Other|Placebo|Intramuscular injections
15797795|NCT04469257|Behavioral|Sunbathing|the individuals were exposed directly to sun in the nursing home garden on open and sunny days without sunscreen for five days a week for a month with an average of 21.0 ± 5.0 min (min 15 min - max 30 min). About 30-35% of their bodies (hand, face, neck, forearm open up to elbows and legs open up to the knee caps) were open.
15797796|NCT04469231|Device|Anterior Cervical Discectomy & Fusion|ACDF
15797798|NCT04469192|Other|Cryotherapy|intervention group will receive a 20-minute topical cryotherapy treatment (using Medline Deluxe Cold Pack) The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture
15797799|NCT04469192|Other|Education|The education portion will consist of a handout that will be provided to each patient describing specific exercises. These exercises include descriptive information along with pictures on ways to improve posture and protect the lower back in pregnancy good posture
15797802|NCT04469166|Procedure|tourniquet|Use of tourniquet
15797803|NCT04469166|Procedure|No tourniquet|No use of tourniquet
15797804|NCT04469153|Other|No intervention / Evaluation of the ferritin and glycosylated ferritin by standard approved serological tests|No intervention / Evaluation of the ferritin and glycosylated ferritin by standard approved serological tests
15797805|NCT04469140|Device|SS-OCT imaging|All subjects will undergo retinal imaging using the Zeiss PlexElite SS-OCT, a non-contact, non-invasive ocular imaging instrument
15797810|NCT04469088|Other|Dry needling|Twenty-three patients with TJD will be allocated in Dry Needling Group. They will receive 3 sessions of dry needling separated for 4 days. This treatment will consist of puncturing the active myofascial trigger points (PGM) of the aforementioned muscles. Sterile acupuncture needles of 0.26 mm in diameter by 40 mm in length, guided with a plastic cannula of the Ener-qi brand, will be used. The area will be cleaned with alcohol and a deep puncture of the PGM will be performed, triggering local spasm responses. Needle through the muscle following the technique described by Hong (Hong et al. 1994). After the procedure, the area is compressed with cotton for 90 seconds.
15797811|NCT04469088|Other|Manual Therapy Treatment|Twenty-three patients will be allocated in Manual Therapy (MT) Group for three sessions during 30 minutes. MT treatment will consist in the application of neuromuscular techniques of the temporal, masseter and sternocleidomastoid muscles and Jones techniques in the external pterygoid muscle. Neuromuscular techniques are performed with the index and major fingers to apply a transverse friction with enough pressure to feel vertical fibers of each muscle or produce a medium discomfort level. To perform the Jones technique on the external pterygoid muscle, the patient will be asked to open the mouth and deviate the jaw slightly towards the treated side in order to make room for the finger to be located between the upper jaw and the coronoid process. Once the trigger point is located, we press to trigger the pain and we look for neurological silence and we maintain the pressure for 90 seconds. Over time, we slowly withdraw the pressure and return to the position passively.
15797814|NCT04469062|Drug|Mirikizumab IV|Administered IV
15797815|NCT04469062|Drug|Mirikizumab SC|Administered SC
15797816|NCT04469062|Drug|Vedolizumab IV|Administered IV
15797817|NCT04469062|Drug|Placebo IV|Administered IV
15797818|NCT04469062|Drug|Placebo SC|Administered SC
15797819|NCT04469049|Behavioral|Mindfulness-based cognitive therapy (MBCT)|MBCT is an evidence-based psychotherapy which combines mindfulness skills with cognitive therapy strategies.
15797820|NCT04469036|Other|Virtual Pediatric Trauma Center|Telehealth
15797821|NCT04469023|Drug|TS-142|Participants received multiple-dose of 2.5, 5, 10 mg of TS-142 or placebo (oral tablet)
15797822|NCT04469010|Dietary Supplement|Iron Bis-Glycinate Chelate and Vitamin C|28 mg iron 240 mg vitamin C
15797823|NCT04469010|Dietary Supplement|Iron Bis-Glycinate Chelate|28 mg iron
15797824|NCT04469010|Dietary Supplement|Placebo|Matched placebo
15797825|NCT04468997|Drug|Drug 601|Recombinant humanized anti-VEGF monoclonal antibody, drug 601(0.375mg), Vitreous injection, injection once;
15797826|NCT04468997|Drug|Drug 601|Recombinant humanized anti-VEGF monoclonal antibody, drug 601(0.75mg), Vitreous injection, injection once;
15797827|NCT04468997|Drug|Drug 601|Recombinant humanized anti-VEGF monoclonal antibody, drug 601(1.25mg), Vitreous injection, injection once;
15797828|NCT04468997|Drug|Drug 601|Recombinant humanized anti-VEGF monoclonal antibody, drug 601(2.5mg), Vitreous injection, injection once;
15797829|NCT04468997|Drug|Drug 601|Recombinant humanized anti-VEGF monoclonal antibody, drug 601(1.25mg), Vitreous injection, injection once every 4 weeks, three times continuously, then injection as needed within 9 months.
15797830|NCT04468997|Drug|Drug 601|Recombinant humanized anti-VEGF monoclonal antibody, drug 601(2.5mg), Vitreous injection, injection once every 4 weeks, three times continuously, then injection as needed within 9 months.
15797834|NCT04468971|Biological|CK0802|Cryopreserved, off the shelf, cord blood derived T regulatory cells
15797835|NCT04468971|Drug|Placebo|Expicient
15797838|NCT04468945|Other|mirror box therapy|"Patients in Task-specific mirror box therapy group will receive therapy for 30 min/day, 3 times/week for 6 weeks.
~The patient is seated close to a table a mirror (33*35 cm) was placed vertically. The involved hand was placed behind the mirror and uninvolved in front of the mirror.
~The subject is asked to transfer small cubes from the middle position to the lateral side, placing pegs in holes and taking them out, turning over paper cards, placing steel needles in holes, stacking blocks, and putting glass on a shelf.
~During the sessions, subjects will be asked to try and do the activity on the unaffected side and asked to do some movement with the paretic hand simultaneously."
15797839|NCT04468945|Other|Repetitive Facilitation Exercise|"The patients in the control group will receive Repetitive Facilitation Exercise for 30 min/day, 3 times/week for 6 weeks.
~Repetitive facilitative techniques were used to elicit movement of the shoulder, elbow, wrist, and fingers in a manner designed to minimize synergistic movements.
~Participants were directed to concentrate on generating movement on the joint being treated while avoiding contraction of non-targeted muscles.
~Therapists provided verbal directions with commands such as bend/straighten or one, two, three.
~Participant efforts were supplemented as necessary to achieve a full range of motion (ROM)"
15797914|NCT04468321|Device|Apple Watch|Participants will be assigned to the Apple Watch arm to assess the impact of individual use of the Apple Watch on patient-reported and clinical utilization outcomes using Hugo.
15797840|NCT04468932|Device|Repetitive transcranial magnetic stimulation (rTMS)|"Aim 1: To determine the clinical effects of rTMS targeting the cerebellum on postural instability in PSP. The hypothesis to be tested is that TMS augmentation of cerebellar inhibition will improve cerebellum-dependent balance symptoms of PSP for a period of time sufficient to improve rehabilitation outcomes. The investigators will measure a battery of objective posturography metrics and other measures of motor control, including sway and center of pressure changes to backward tilt and forward translation.
~Aim 2: To determine the effects on brain network connectivity of rTMS targeting the cerebellum in PSP. The hypothesis to be tested is that resting state fMRI connectivity between the cerebellum, thalamus, and cortex will be enhanced after rTMS, reflecting increased cerebellar inhibition of the motor cortex after treatment."
15797841|NCT04468919|Behavioral|BCI-FIT multi-modal access|Adding a personalized multi-modal access protocol to customize a BCI-FIT access method configuration for each individual end user, based on a combination of user characteristics, clinical expertise, user feedback, and system performance data in the software.
15797842|NCT04468919|Behavioral|BCI-FIT adaptive signal modeling|Adding a BCI-FIT adaptive signal modeling that employs transfer learning and on-line model adaptation techniques with noisy labels in the software of this brain-computer interface to eliminate the need for data collection exclusively for model calibration, as well as to address model drift issues associated with drowsiness, fatigue, and other human and environmental factors.
15797843|NCT04468919|Behavioral|BCI-FIT active querying|Adding BCI-FIT active querying techniques which are software-based optimal action control policies in the brain-computer interface developed with active and reinforcement learning techniques in order to perform efficient user intent inference to improve the entire speed-accuracy trade-off curve for alternative communication.
15797844|NCT04468919|Behavioral|BCI-FIT language modeling|Adding vocabulary and location information (called partner and environmental input) to the language models in the brain-computer interface from a user's communication partner and from automatic speech recognition on the spoken utterances of interlocutors.
15797845|NCT04468906|Procedure|Biceps Tenodesis|Biceps tenodesis describes the surgical procedure that will be performed to treat LHBT lesions.
15797846|NCT04468906|Procedure|"Self-locking T Tenotomy"|"Self-locking T Tenotomy describes the surgical procedure that will be performed to treat LHBT lesions."
15797847|NCT04468893|Behavioral|Online Intervention Mental Health COVID-19|The Online Intervention Mental Health COVID-19 aims to provide to the target population a self-applied intervention based primarily on Positive Psychology, aimed at the recognition and development of strengths and virtues from the well-being approach. In addition, it is supported by elements of Cognitive Behavioral Therapy such as the components of emotion and the Antecedent-Response-Consequence (ARC) model of emotions. Elements of Behavioral Activation Therapy are also included, such as the importance of physical exercise and the relationship between physical anxiety and its effects on anxiety and depression. The intervention is made up of 15 modules that are adapted to the symptoms that the population may suffer from the global contingency caused by the COVID-19 pandemic. In addition to the Positive Psychology modules, a module with psychoeducation on grief and loss was added.
15797848|NCT04468880|Other|Group (A1 → A2)|"Before each start of consumption of the products under study, a wash-out period of 2 weeks (no consumption of milk) must be observed by the subjects.
~25 subjects will consume A1A2 milk for 2 weeks (period 1), then they will consume A2A2 milk for 2 weeks (period 2).
~During each consumption period, various questionnaires will be completed by the subjects: frequency and consistency of stool, analog visual scales on digestive comfort and dietary surveys. Stool collections will also be carried out."
15797849|NCT04468880|Other|Group (A2 → A1)|"Before each start of consumption of the products under study, a wash-out period of 2 weeks (no consumption of milk) must be observed by the subjects.
~25 subjects will consume A2A2 milk for 2 weeks (period 1), then they will consume A1A2 milk for 2 weeks (period 2).
~During each consumption period, various questionnaires will be completed by the subjects: frequency and consistency of stool, analog visual scales on digestive comfort and dietary surveys. Stool collections will also be carried out."
15797850|NCT04468867|Diagnostic Test|Automated whole breast ultrasound|This will be performed by a band 6 radiographer and will be done at baseline, post 2 cycles of chemotherapy and end of treatment chemotherapy
15797851|NCT04468867|Diagnostic Test|Breast MRI|This will be performed by band 6 or 7 radiographer with MRI training
15797852|NCT04468854|Dietary Supplement|Luteolin|Luteolin extracted from Chrysanthemum Ramat 98% HPLC by Scyherb® food grade certified according to Safe Quality Foods (SQF) - Level 3 Comprehensive Food Safety and Quality Management System Certification by the Safe Quality Food Institute (SQFI).
15797853|NCT04468854|Other|Placebo|mannitol formulated for oral administration (capsules)
15797854|NCT04468841|Diagnostic Test|cfDNA testing|peripheral blood samples collected before initiation of standard therapy, after 2 cycles of therapy, at the completion of 6-8 cycles of induction therapy, and then every 6 months for a total of 2 years from the initiation of therapy using a ctDNA assay. For retrospective patients, blood samples will be collected once.
15797855|NCT04468841|Other|sample of saliva or fingernail clipping|collected in clinic one time
15797856|NCT04468841|Diagnostic Test|pre-treatment test specimen|From bone marrow, blood, lymph node, or alternate site to identify tumor-specific mutations. For retrospective patients initial tumor tissue (if available).
15797857|NCT04468841|Diagnostic Test|PET/CT, CT, or MRI testing|PET/CT scans are required at baseline and at the patient's end-of-treatment visit. The other standard-of-care scan timepoints can be performed using PET/CT, dedicated CT, or MRI per the treating investigator's discretion.
15797858|NCT04468815|Drug|BMS-986278 Tablet|Specified dose on specified days
15797859|NCT04468815|Drug|Esomeprazole|Specified dose on specified days
15797860|NCT04468815|Drug|BMS-986278 suspension|Specified dose on specified days
15797861|NCT04468802|Other|Case fatality rate|Mortality rate caused by SARS CoV-2
15797862|NCT04468789|Other|Six-month ARV dispensing|Patients in the intervention group who meet eligibility criteria will receive a six-month supply of antiretroviral medications, rather than the standard of care supply which is typically 2-3 months.
15797863|NCT04468776|Drug|Zolpidem|Zolpidem, as prescribed by physician
15797864|NCT04468776|Behavioral|Internet Cognitive Behavioral Therapy for Insomnia (CBT-I)|6-week internet CBT-I multi-component intervention (SHUTi) including sleep restriction, stimulus control, cognitive restructuring, sleep behaviors, and relapse prevention
15797865|NCT04468776|Drug|Trazodone|Trazodone, as prescribed by physician
15797868|NCT04468724|Behavioral|MAKASI|"The Makasi intervention consists in a unique Empowerment interview, based on motivational interviewing techniques. Is is made of three components:
~Listening and building trust
~Active referral to structures that answers sanitary and social needs
~Sexual Health Prevention
~Materials used are: referral letters, bilingual health guides, adapted maps of the the neighborhoods with useful addresses.
~The Makasi intervention is proposed and delivered in an outreach setting: health mediators propose information on general health and rapid HIV and HCV testing. They screen the people attending and propose Makasi to eligible persons."
15797869|NCT04468711|Drug|Vitamin D|Vitamin D plus topical 1% hydrocortisone cream twice daily
15797870|NCT04468711|Drug|Placebo|placebo plus topical 1% hydrocortisone cream twice daily
15797871|NCT04468698|Other|Peritoneum insufflation|Before surgery pneumoperitoneum is established by insufflating gas into the abdomen. Intraabdominal pressure (IAP) is set to 15 mmHg for initial abdominal stretching and then decreased in a stepwise manner down until 8 mmHg.
15797872|NCT04468685|Drug|Ondansetron|Interperitoneal administration in the gall bladder bed
15797873|NCT04468685|Drug|Normal saline|Interperitoneal administration in the gall bladder bed
15797874|NCT04468672|Behavioral|Portion size|The amount of food served (g) at the first two meals of each day. These amounts will vary across 4 weeks.
15797875|NCT04468659|Drug|Lecanemab|IV infusion.
15797876|NCT04468659|Drug|Placebo|IV infusion.
15797877|NCT04468646|Drug|NK-1R antagonist|NK-1R antagonist, 80 mg daily once for 3-5 days along with dexamethasone 6 mg daily for 5 days
15797878|NCT04468633|Device|Baerveldt 350 implant|The Baerveldt implant is an FDA-approved silicone, non-valved implant.
15797879|NCT04468633|Device|Ahmed ClearPath 350 implant|The Ahmed ClearPath is a non-valved glaucoma drainage device.
15797880|NCT04468620|Behavioral|Assistive Soft Skills & Employment Training (ASSET)|The ASSET curriculum covers six key social skill areas: (a) Communication; (b) Networking; (c) Attitude & Enthusiasm; (d) Teamwork; (e) Problem Solving & Critical Thinking; and (f) Professionalism, as well as new content added based on our pilot findings (Mental Health; Stress Management and Self-Advocacy; and Awareness of Self & Others). The schedule includes two sessions for Communication and Professionalism, and a graduation session; thus, bringing the total number of sessions to 13. The structural elements of the training format include didactic lecture, experiential activities, group discussions, role-plays, performance feedback,and weekly take-home assignments. A key element is a social hour following each 90-minute session, in which participants practice learned skills while sharing a meal.
15797882|NCT04468594|Other|rigid tapping|Taping techniques We will use rigid tape and apply it bilaterally. In the rigid tape application, a combination pack of zinc oxide tape and the protective tape will be used. The protective tape will be applied first with no tension. To apply the rigid tape, subjects will be instructed to place their thoracic spine in a neutral position, the rigid tape will be applied bilaterally from the first to the twelfth thoracic vertebra. Subjects will be asked to retract and depress the scapula. The rigid tape will be applied diagonally from the middle of the scapular spine to the twelfth thoracic vertebra; this technique will be applied bilaterally. The rigid tape will be applied 3 times per week and will be applied for 6 weeks.
15797883|NCT04468594|Other|scapular stabilizing excercise|"consisted of:
~wall slides with squat,
~wall push-ups plus ipsilateral leg extension,
~lawnmower with diagonal squat,
~resisted scapular retraction with contralateral leg squat and robbery with squat.
~Robbery with squat
~Resisted shoulder internal rotation with step
~Resisted shoulder external rotation with step
~Resisted full can with step All resisted exercises were performed with elastic bands with red color-coded resistance levels and progressed through green and blue bands The patient will perform 10 repetitions 3 sets to 15 repetitions 3 sets and 20 repetitions 3 sets weekly."
15797884|NCT04468594|Other|therapeutic exercises|"Pectoralis minor stretching
~Posterior shoulder stretching
~Levator scapula stretching
~Latissimus dorsi stretching ( stretching exercises will be 5 repetitions each session - 3 times per week)
~Resisted shoulder internal rotation
~Resisted shoulder external rotation
~Resisted full can (strengthening exercises will be 510 repetitions each session - 3 times per week) All resisted exercises were performed with elastic bands with red color-coded resistance levels and progressed through green and blue bands NOTE. All resisted exercises were progressed from starting 10 repetitions 3 sets to 15 repetitions 3 sets and 20 repetitions 3 sets weekly, supervising movement quality, presence of pain, and fatigue. If the subject achieves 20 repetitions 3 successfully, heavier resistance with resistance band color-coded loading prescribed from 10 repetitions 3 sets."
15797885|NCT04468581|Behavioral|Use of mobile application|Use of the TraceTogether mobile application during the COVID-19 period
15797886|NCT04468568|Drug|Atosiban|Atosiban intravenous. Dose: attack of 6.75 mg, and maintenance of 300 mcg / min for 3 hours, and 100 mcg / min for 45 h.
15797887|NCT04468568|Drug|Terbutaline|Terbutaline intravenous. Dose: 2.5 mg in 500 mL saline, infusion rate of 30 mL / hr (150 mcg / hr) during the surgery
15797888|NCT04468555|Other|Global postural reeducation|It consisted of Global Postural Re-Education sessions divided into 3 sessions and performed with a frequency of 1 per week for 3 weeks. The sessions were performed individually, with an approximate duration of 40 minutes and all of them were assessed by the same physiotherapist.
15797889|NCT04468542|Drug|Superior laryngeal nerve block - Intervention (Bupivacaine and triamcinolone acetonide suspension)|2-cc injection (mixture consisting of 1-cc of 0.5% Bupivacaine injection and 1cc of 40mg/cc triamcinolone acetonide suspension injection) will be delivered percutaneously into the region of the proximal superior laryngeal nerve, every 1-2 weeks, for total of 2 to 3 injections
15797890|NCT04468542|Drug|Superior laryngeal nerve block - Placebo (saline)|2-cc injection of saline will be delivered percutaneously into the region of the proximal superior laryngeal nerve, every 1-2 weeks, for total of 2 to 3 injections
15797891|NCT04468529|Drug|Recombinant human Neuregulin for injection|10 hours per day i.v. drip for the first 10 days (0.6ug/kg/day)
15797892|NCT04468529|Drug|Placebo|10 hours per day i.v. drip for the first 10 days (0ug/kg/day)
15797893|NCT04468516|Device|KKT|Vibroacoustic sound waves applied focally.
15797894|NCT04468516|Device|sham KKT|sham KKT
15797915|NCT04468321|Device|Withings Move|Participants will be assigned to the Withings Move arm to assess the impact of individual use of the Withings Move on patient-reported and clinical utilization outcomes using Hugo.
15797895|NCT04468503|Other|Two differnt protien prescription (ig per kg per day and 2g per kg /day )will be assigned to each group interventional|In this study intervention will be the dose of protein, one group will be prescribed with the protein dose (1 g/kg/day) and other group will be on prescribed higher dose (2gm/kg/day) of protein according to the ASPEN guideline for critically ill and the energy requirements (other than proteins) will be 25 kcal/kg of adjusted body weight (Picolo et al.,). Each subject in the trail will provide remaining medical nutrition therapy according to the therapeutic guidelines in the field. The medical nutrition management other than protein will be adjust according to need of each patient.
15797896|NCT04468477|Device|6 Lead ECG|Patients will be assessed with the Kardiamobile device.
15797897|NCT04468464|Other|Occlusal Splint Treatment|Occlusal splint is used by a dentist during sleep or day time to protect the teeth and temporomandibular joint. Manufactured individually by the technicians according to the dentists measurement procedure.
15797898|NCT04468464|Other|Osteopathic Manual Treatment|Osteopathy treats the body as a whole and applied by hands over the related structures of the body. TMJ, Cervical, Thoracal, Lumbar vertebra mobilization was applied as well as the fascial and visceral mobilization. Patients also used occlusal splint for 6 weeks during the intervention.
15797899|NCT04468451|Behavioral|A 48-hour ROC training program with a standing posture|The 2-hour training session is composed of two 30-minute driving sessions and two 25-minute natural play sessions, with a 10-minute break. Every week's treatment program will be before planned and adjusted by the therapist and the caregivers through discussion and clinical observation of participant's performance in the previous session. Training will concentrate on building the concept of casual-effect on the switch and car motion, goal-oriented driving in a hospital, and upper limb use in functional tasks with driving and hand use in functional tasks for exploration in natural play session.
15797900|NCT04468451|Behavioral|A 24-hour ROC training program with a standing posture|The 1-hour training session is composed of a 30-to-35-minute car play and a 25-minute natural play. Every week's treatment program will be before planned and adjusted by the therapist and the caregivers through discussion and clinical observation of participant's performance in the previous session. Training will concentrate on building the concept of casual-effect on the switch and car motion, goal-oriented driving in a hospital, and upper limb use in functional tasks with driving and hand use in functional tasks for exploration in natural play session.
15797901|NCT04468451|Behavioral|A regular therapy program without receiving any ROC training|The regular therapy group will be an active control group without receiving any additional training. The training dosage will be their own therapy, including occupational, physical and speech therapy. They will continue their regular therapy, including physical, occupational and speech therapy. The general propose of the training is to improve the developmental scales, mobility, socialization and upper limb use in functional tasks.
15797902|NCT04468438|Diagnostic Test|serum estrogen and urinary albumin creatinine ratio|serum estrogen and urinary albumin creatinine ratio
15797903|NCT04468425|Drug|Tofacitinib Citrate|Period 1: Xelijanz® 5 mg tablet (tofacitinib citrate) for single oral dosing. Period 2: Tofacitinib Citrate Topical Gel 3.2% for repeat topical dosing BID for 14 days.
15797904|NCT04468412|Diagnostic Test|Carotid Artery Reactivity Testing|The carotid artery reactivity (CAR) test assesses macrovascular endothelial function by measuring the carotid artery diameter in response to sympathetic stimulation. Participants are in the supine position with the neck extended for assessment of the carotid artery. Left carotid artery diameter is recorded continuously during baseline (30 seconds) and during immersion of the right hand up to the wrist in icy water (4°C) for 3 minutes. CAR can either represent a dilatory response (normal endothelial function) or a constrictive response (endothelial dysfunction) of the carotid artery.
15797905|NCT04468399|Other|Routine medical record data collection|The study will collect routine medical record data from the electronic medical record system, other electronic databases, and paper charts.
15797906|NCT04468399|Other|Interviews with service providers|Clinicians and lay staff will be interviewed regarding the ART initiation process.
15797907|NCT04468373|Device|WA-NG (NG-IMT) Telescope Prothesis|The WA-NG telescope prosthesis is the next generation telescopic implantable device which, when combined with the optics of the cornea, constitutes a telephoto system for improvement of visual acuity in patients with severe to profound vision impairment due to bilateral, end-stage age-related macular degeneration. The device is implanted in one of the patient's eyes. In this way, the implanted eye provides central vision and the non-implanted eye can continue to provide peripheral vision.
15797911|NCT04468347|Drug|Flortaucipir F18|IV injection, 240 megabecquerel (MBq) (6.5 mCi)
15797912|NCT04468347|Procedure|Brain PET scan|positron emission tomography (PET) scan of the brain
15797913|NCT04468334|Device|LARIAT + PVI|LAA ligation with the LARIAT System initially performed followed by adjunctive PVI catheter ablation (RF or cryoballoon) in staged procedures
15798062|NCT04467177|Other|30% glucose|Male neonates will receive 2 ml of 30% glucose two minutes prior to circumcision
15797916|NCT04468308|Other|Questionnaire|Patients complete the National Eye Institute Visual Function Questionnaire 25 pre-operative, 1 month and 3 month postoperatively.
15797917|NCT04468295|Procedure|Bonding|Bonding of upper and lower arches including 2nd maxillary molars with bracket prescription Roth 0.018 inch
15797918|NCT04468295|Procedure|Leveling and alignment|Leveling and alignment till 0.016 x0.022 Ni Ti
15797919|NCT04468295|Procedure|Extraction|Extraction of maxillary 1st premolars
15797920|NCT04468295|Procedure|Retraction|En-masse retraction using 0.017x0.025 TMA T loop
15797921|NCT04468295|Procedure|Digital models|impression taking and digital scanning
15797922|NCT04468295|Procedure|measurement|Assessment the rate of retraction for 6 months
15797923|NCT04468282|Drug|VGB-ST|Single oral administration of 500 mg VGB-ST
15797924|NCT04468269|Other|Task oriented balance training with sensory integration group|"Sitting position:
~Sit in a chair without backrest while keeping the feet on floor.
~Sit on a ball while keeping the feet on the floor.
~Sit to stand:
~Sit in a chair without a backrest
~Sit in a chair without a backrest with and perform the sit-to-stand motion repeatedly.
~Sit on a ball and perform the sit-to-stand motion repeatedly.
~Standing position:
~Perform bipedal standing Control Of Weight Shifting. Perform a semi-tandem stance. One Foot Standing.
~Walking:
~Walk forward
~Walk forward cross an obstacle, and then continue to walk.
~Walk Lateral
~Walk Backward
~Tandem walk"
15797925|NCT04468269|Other|Task oriented balance training without sensory integration group|"Sitting position:
~Sit in a chair without a backrest while keeping the feet on a firm surface.
~Sit on a ball while keeping the feet on the firm surface
~Sit to stand:
~Sit in a chair without a backrest with the feet on a firm surface and perform the sit-to-stand motion repeatedly.
~Sit on a ball with the feet on the firm surface and perform the sit-to-stand motion repeatedly.
~Standing position:
~Perform bipedal standing on a firm surface.
~Perform a semi-tandem stance on the firm surface
~Walking:
~Walk forward on a firm surface.
~Walk forward on the firm surface, cross an obstacle, and then continue to walk.
~Walk sideways
~Walk Backward
~Tandem walk"
15797926|NCT04468256|Other|COVID-19 experience surveys|Serial online surveys recording experiences of the COVID-19 pandemic.
15797927|NCT04468243|Other|Nurse-led diabetes care|Nurse-led brief diabetes education, instructions on glucometer and Metformin use, patients receive prescriptions for Metformin and blood glucose testing kit
15797928|NCT04468230|Drug|Nicotine Transdermal Patch|Nicotine Treatment Condition
15797929|NCT04468217|Diagnostic Test|Obtainment of nasopharyngeal, oropharyngeal, buccal, nasal and saliva samples|Each patient will undergo a sample collection where two nasopharyngeal samples will be obtained, one of them with lysis buffer as the transport medium and the other with the AAA-Safe solution as the transport medium. Oropharyngeal, buccal, nasal, and salivary samples will also be obtained using AAA-Safe as the transport medium
15797930|NCT04468204|Device|SinuSonic Device|A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion.
15797931|NCT04468204|Device|Sham SinuSonic Device|Sham positive expiratory pressure intervention using the SinuSonic Device.
15797932|NCT04468191|Device|Experimental expiratory muscle strength training (EMST)|The experimental EMST will involve blowing into a device with a spring-loaded valve set to 50% of the patient with ALS' maximum expiratory pressure.
15797933|NCT04468191|Device|Sham expiratory muscle strength training (EMST)|The sham EMST will involve blowing into a device without a spring-loaded valve (0% resistance).
15797934|NCT04468178|Device|Total joint arthroplasty of the glenohumeral joint|The arthroplasty of the glenohumeral joint will be performed as an anatomical reconstruction after primary or post-traumatic osteoarthritis.
15797935|NCT04468165|Drug|Dimethyl Fumarate (DMF)|Gastro-resistant Hard Capsules. Each capsule contains 240mg or 120mg Dimethyl Fumarate
15797936|NCT04468152|Behavioral|Dietary habits and intake|Optical coherence tomography (OCT) withdrawals and central foveal thickness (CFT) evaluations of those included in the study were made by the doctor and directed to the dietician (researcher). The dietary intake of participants was assessed using a validated quantitative food frequency questionnaire (QFFQ) (21). The total food intake was then converted to total nutrient intake based on the food's nutrient profile. Standardized food recipes for Turkey and the Nutrition Information System (BEBIS) program, which is a food composition database for nutrient estimation, were used to determine the average daily energy and nutrient intake for each participant.
15797937|NCT04468139|Drug|Quercetin|Dietary Supplement: Quercetin Treatment a daily dose of quercetin (500 mg) will be taken orally by proven COVID-19 cases intervention
15797938|NCT04468139|Dietary Supplement|bromelain|Dietary Supplement:Bromealin Treatment a daily dose of bromelain(500 mg) will be taken orally by proven COVID-19 cases intervention
15797939|NCT04468139|Drug|Zinc|zinc 50 mg orally daily dose will be taken orally by proven COVID-19 cases intervention
15797940|NCT04468139|Drug|Vitamin C|vitamin c 1000 mg orally daily by proven COVID-19 cases intervention
15797941|NCT04468126|Other|Standard oxygen|Standard low flow oxygen therapy through facemask or non-rebreathing mask at least 10 L/min.
15797942|NCT04468126|Other|High-flow nasal oxygen therapy|Humidified and heated oxygen with a gas flow at least 50 l/min through nasal cannula and inspired fraction of oxygen adjusted in order to maintain a SpO2 between 92 and 96%
15797943|NCT04468113|Device|Tumark® Vision clip|Suspicious intramammary lesion is marked with clip
15797944|NCT04468100|Biological|Tigerase®|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 168 (+/-7) days
15797945|NCT04468100|Biological|Pulmozyme®|2.5 mL (2.5 mg) dornase alfa nebulized once daily for 168 (+/-7) days
15797946|NCT04468087|Drug|Atazanavir|600 mg (2 capsules) twice daily on the first day and 300 mg (1 capsule) twice daily for the subsequent 9 days.
15797947|NCT04468087|Drug|Daclatasvir 60 mg|initial dose of 120mg (2 capsules), followed by 60mg (1 capsule) once daily for 9 days.
15797948|NCT04468087|Drug|Sofusbuvir + Daclastavir 60 mg|400 mg twice daily (2 capsules) on the first day and 400 mg (1 capsules) once daily for the subsequent 9 days (sofusbuvir) + initial dose of 120mg (2 capsules), followed by 60mg (1 capsule) once a day for 9 days (daclastavir)
15797949|NCT04468087|Drug|Placebo Atazanavir|2 capsules twice daily on the first day and 1 capsule twice daily for the subsequent 9 days.
15797950|NCT04468087|Drug|Placebo Daclatasvir 60 mg|2 capsules twice daily on the first day and 1 capsule twice daily for the subsequent 9 days.
15797951|NCT04468087|Drug|Placebo Sofusbuvir + Daclatasvir 60 mg|2 capsules twice daily on the first day and 1 capsule twice daily for the subsequent 9 days.
15797952|NCT04468074|Device|Virtual Reality Therapy for Chronic Pain|"A 1 1/2 PowerPoint-based education session on the science behind chronic pain and a basic overview of the VR therapy
~Virtual Reality Therapy: a virtual reality therapy consisting of different psychological training exercises"
15797953|NCT04468061|Drug|Sacituzumab Govitecan|Intravenous Infusion
15797954|NCT04468061|Drug|Pembrolizumab|Intravenous Infusion
15797955|NCT04468048|Other|"Music: Nada Himalaya performed by S. G. Sachchidananda"|"Music: Nada Himalaya performed by S. G. Sachchidananda"
15797956|NCT04468022|Procedure|Toric Trifocal IOL|Interventions are performed using a standard technique of sutureless phacoemulsification. In all cases, topical anesthesia was administered and pharmacologic mydriasis was induced using a combination of tropicamide and phenylephrine (10.0%). A mean clear corneal microincision of 2.2 mm was made with a knife according to position of the preop highest K value of the patient. A paracentesis was made 60 degree to 80 degree, clockwise from the main incision, and the anterior chamber was filled with an ophthalmic viscoelastic (OVD) after phacoemulsification/lensectomy and removal of clear lens. The IOL was subsequently implanted through the main incision using the BLUEMIXS 180 injector (Carl Zeiss meditec, Jena, Germany) for trifocal IOL , VISCOJECTTM BIO injector for toric trifocal IOL and then the OVD was removed. Postoperative pharmacologic treatment is performed with the combination of antibiotic and steroidal anti-inflammatory drops
15797957|NCT04468009|Biological|Convalescent plasma|Convalescent plasma from patients recovering from Covid-19 and which had anti-SARS-Cov-2 antibodies
15797958|NCT04467996|Device|Intrauterine balloon tamponade|Intrauterine balloon will be placed in the uterus for postpartum hemorrhage control.
15797959|NCT04467983|Drug|Denosumab Injection|Denosumab alone: 3 injections of Denosumab at appropriate times, separated by no more than 7 months from the last treatment.
15797960|NCT04467983|Drug|Abaloparatide|Combination therapy: 3 injections of Denosumab at appropriate times, separated by no more than 7 months from the last treatment, with added abaloparatide 80 mcg subcutaneously daily, started within 6 months of the last denosumab treatment, for a total of 18 months.
15797961|NCT04467970|Procedure|Unicompartmental Knee Replacement|Unicompartmental Knee Replacement involves replacement of the medial compartment of the knee in patients with anteromedial osteoarthritis.
15797962|NCT04467970|Procedure|High Tibial Osteotomy|High Tibial Osteotomy involves medial wedge opening high tibial osteotomy in cases of anteromedial osteoarthritis.
15797963|NCT04467957|Drug|Initiation of CFTR Modulator|Inhaled contrast for MRI occurring at each visit
15797964|NCT04467957|Drug|Hyperpolarized Xenon 129|Inhaled contrast for MRI occurring at each visit
15797965|NCT04467944|Other|Pre-existing degenerative factors at adjacent segment|Pre-existing degenerative factors at adjacent segment, including disc factors and canal stenosis factors
15797966|NCT04467931|Drug|ACEI/ARB|Veterans will be categorized as exposed to ACEI/ARB if they have one or more pharmacy fills for an oral ACEI or an ARB in the 90 days (± 14 days) prior to each Veteran's index date. Sacubitril/valsartan (Brand name: Entresto®) will be excluded from ARB exposures.
15797967|NCT04467931|Drug|Non-ACEI/ARB|Veterans will be categorized as exposed to a non-ACEI/ARB if they have one or more pharmacy fills for an oral non-ACEI or ARB medication in the 90 days (± 14 days) prior to each Veteran's index date and NO fills for an ACEI/ARB medication in the 90 days (± 14 days) prior to each Veteran's index date. Specific drug classes include: aldosterone receptor antagonist, beta-blocker, calcium channel blocker, centrally-acting drug, direct arterial vasodilator, direct renin inhibitor, thiazide diuretic, loop diuretic, and potassium sparing diuretic.
15797968|NCT04467931|Drug|ACEI|Veterans will be categorized as exposed to an ACEI if they have one or more pharmacy fills for an oral ACEI in the 90 days (± 14 days) prior to each Veteran's index date and NO fills for an oral ARB in the 90 days (± 14 days) prior to each Veteran's index date.
15797969|NCT04467931|Drug|ARB|Veterans will be categorized as exposed to an ARB if they have one or more pharmacy fills for an oral ACEI in the 90 days (± 14 days) prior to each Veteran's index date and NO fills for an oral ACEI in the 90 days (± 14 days) prior to each Veteran's index date. Sacubitril/valsartan (Brand name: Entresto®) will be excluded from ARB exposures.
15797970|NCT04467918|Drug|Cannabidiol|Already described
15797971|NCT04467918|Other|PLACEBO|Already described
15797972|NCT04467905|Drug|Etripamil|The formulation of etripamil Nasal Spray will consist of MSP-2017 (etripamil), water, acetic acid, disodium ethylene-diamine-tetra-acetic acid (EDTA), and sulfuric acid. The dose of etripamil to be evaluated in this study is 70 mg.
15797973|NCT04467905|Drug|Placebo|The formulation of placebo will consist of water, sodium acetate, disodium, disodium ethylene-diamine-tetra-acetic acid (EDTA), and sulfuric acid to reproduce the same pH as the etripamil formulation.
15797974|NCT04467892|Drug|methylprednisolone|received high dose (30 mg/kg) methylprednisolone slowly intravenous in 250 ml normal saline every 8 hours for only 4 days
15797975|NCT04467892|Drug|Methyl Prednisolonate|received 1 mg/kg/day methylprednisolone divided to three doses given every 8 hours for two weeks.
15797976|NCT04467892|Device|ventilators|all patients in both groups will be ventilated with CMV for 2 weeks
15797979|NCT04467866|Behavioral|A Ride-on Car with a Standing Posture|The 2-hour training session is composed of two 30-minute driving sessions and two 25-minute natural play sessions, with a 10-minute break. Every week's treatment program will be before planned and adjusted by the therapist and the caregivers through discussion and clinical observation of participant's performance in the previous session. Training will concentrate on building the concept of casual-effect on the switch and car motion, goal-oriented driving in a hospital, and upper limb use in functional tasks with driving and hand use in functional tasks for exploration in natural play session.
15797980|NCT04467866|Behavioral|Regular Therapy Program|The goals are to improve certain motor skills or psychosocial skills based on each participant's current developmental stage. The general propose of the training is to facilitate the developmental scales and improve mobility, socialization and upper limb use in functional tasks. Each participant will have the opportunity to walk on the hallway/public space and interact with the therapist and caregivers depending on his/her motor abilities.
15798063|NCT04467177|Other|Placebo|Male neonates will receive 2 ml of sterile water two minutes prior to circumcision
15798243|NCT04465734|Drug|Sorafenib|Sorafenib is a multi-target, multi-kinase inhibitor capable.The standard treatment of HCC.
15797981|NCT04467853|Biological|LCAR-C18S cells|Prior to infusion of the LCAR-C18S, subjects will receive a premedication regimen (IV infusion of cyclophosphamide 300 mg/m2 and fludarabine 30mg/m2 once daily (QD) for 3 days; if the subject have a creatinine clearance of 40-70 mL/min/1.73 m2, or for patients > 70 years of age and with a performance status score of 1, dose reduction of fludarabine to 25 mg/m2 and cyclophosphamide to 250 mg/m2 will be allowed). Infusion of LCAR-C18S is scheduled 5 to 7 days after the initiation of the premedication regimen.
15797982|NCT04467840|Drug|Opaganib|Study participants will receive either opaganib 2 x 250 mg capsules (500 mg) every 12 hours, or matching placebo, in addition to standard of care (pharmacological as defined above and/or supportive) at any given institution. Study drug will be administered every day for 14 days (Day 1 to Day 14).
15797983|NCT04467840|Drug|Placebo|Study participants will receive either opaganib 2 x 250 mg capsules (500 mg) every 12 hours, or matching placebo, in addition to standard of care (pharmacological as defined above and/or supportive) at any given institution. Study drug will be administered every day for 14 days (Day 1 to Day 14).
15797984|NCT04467827|Diagnostic Test|examining group|Posture assessment in young healthy people depending on their level of physical activity
15797985|NCT04467814|Behavioral|Better Together|"Patient and caregiver dyads from both groups will receive usual care during hospitalization and following discharge. This will include a handout on strategies for safely remaining active.
~Caregiver participants in the intervention group will receive up to six telephone or video calls with the research assistant or Clinical Resource Therapist. Sessions will review the knowledge translation (KT) product with family members (~15 minutes), art goals, brainstorm strategies, and discuss setbacks. The calls with the caregiver may occur 1 to 2 times in the hospital, within one week of going home, and then in Months 2 and 3."
15797986|NCT04467814|Behavioral|Usual Care|Patient and caregiver dyads from both groups will receive usual care during hospitalization and following discharge. This will include a handout on strategies for safely remaining active.
15797987|NCT04467801|Drug|Ipatasertib|Ipatasertib is a novel ATP-competitive inhibitor. It is taken by mouth once daily.
15797988|NCT04467788|Other|Computer-aided sessions|Changing participants' KAP of ergonomics in dentistry
15797989|NCT04467788|Other|Clinical simulation sessions|Changing participants' KAP of ergonomics in dentistry
15797990|NCT04467749|Other|Suspension Wheel|Participants will be given either a pair of Softwheels or Loopwheels to use during the 12-week intervention period. Softwheels feature a rigid rim and 3 suspension arms built inside the wheel that compress to absorb shocks. Loopwheels offer a rigid rim, a mid-wheel shock absorbing hub and three in-wheel loops that work as a self-correcting system when encountering uneven ground.
15797991|NCT04467736|Device|Gengigel Forte©|Gengigel (hyaluronic acid) will be administered by the patient 3 times per day during 7 days following alveolar ridge preservation
15797992|NCT04467723|Drug|Atezolizumab|Atezolizumab is given as an intravenous infusion at 1200 mg every 3 weeks. Pirfenidone is taken by mouth 3 times a day with the dose increasing every 2 week until day 30
15797993|NCT04467710|Procedure|Laparoscopic common bile duct exploration.|"Laparoscopic common bile duct exploration. ERCP (Endoscopic Retrograde Cholangiopancreatography) with sphincterotomy : : removal of common bile duct stones trought the cystic duct (transcystically) with a Dormia or a choledoscope, or throught the common bile duct with a choledoscope introduced throught an incision of the common bile duct.
~ERCP with sphincterotomy: removal of common bile duct stones throught the duodenal papilla, and a sphincterotomy of the oddi sphincter during the same time."
15797994|NCT04467697|Drug|SOV2012-F1|oral preparation of testosterone undecanoate (TU)
15797995|NCT04467684|Drug|CB-0406 100 mg|Single oral dose
15797996|NCT04467684|Drug|CB-0406 200 mg|Single oral dose
15797997|NCT04467684|Drug|CB-0406 400 mg|Single oral dose
15797998|NCT04467684|Drug|CB-0406 800 mg|Single oral dose
15797999|NCT04467684|Drug|CB-0406 1,000 mg|Single oral dose
15798000|NCT04467684|Drug|Matched placebo|Color and size matched placebo
15798001|NCT04467671|Combination Product|Tissue Engineered Vascular Grafts|Patients will undergo EC TCPC interposition grafting with a tissue engineered vascular graft and serial magnetic resonance imaging (MRI)
15798002|NCT04467658|Diagnostic Test|electroencephalography absolute delta power|We used MATLAB 7.0.1 (Math Works, Natick, MA, USA) and the EEGLAB toolbox to pre-process and analyze the EEG recordings. First, the EEG data were down-sampled to 250 Hz. Next, the EEG data were detrended and mean-subtracted to remove the DC component. A 1-Hz high-pass filter and a 60-Hz notch filter were applied to remove eye and electrical noise. Next, independent component analysis (ICA) was performed to remove the well-defined sources of artifacts. ICA has been shown to reliably isolate artifacts caused by eye and muscle movements and heart noise (23). Finally, clinical psychiatrists and EEG experts visually inspected the corrected EEGs. For the analysis, we selected more than two minutes of artifact-free EEG readings from the three-minute recordings
15798003|NCT04467658|Diagnostic Test|electroencephalography relative delta power|We used MATLAB 7.0.1 (Math Works, Natick, MA, USA) and the EEGLAB toolbox to pre-process and analyze the EEG recordings. First, the EEG data were down-sampled to 250 Hz. Next, the EEG data were detrended and mean-subtracted to remove the DC component. A 1-Hz high-pass filter and a 60-Hz notch filter were applied to remove eye and electrical noise. Next, independent component analysis (ICA) was performed to remove the well-defined sources of artifacts. ICA has been shown to reliably isolate artifacts caused by eye and muscle movements and heart noise (23). Finally, clinical psychiatrists and EEG experts visually inspected the corrected EEGs. For the analysis, we selected more than two minutes of artifact-free EEG readings from the three-minute recordings
15798004|NCT04467658|Diagnostic Test|electroencephalography absolute theta power|We used MATLAB 7.0.1 (Math Works, Natick, MA, USA) and the EEGLAB toolbox to pre-process and analyze the EEG recordings. First, the EEG data were down-sampled to 250 Hz. Next, the EEG data were detrended and mean-subtracted to remove the DC component. A 1-Hz high-pass filter and a 60-Hz notch filter were applied to remove eye and electrical noise. Next, independent component analysis (ICA) was performed to remove the well-defined sources of artifacts. ICA has been shown to reliably isolate artifacts caused by eye and muscle movements and heart noise (23). Finally, clinical psychiatrists and EEG experts visually inspected the corrected EEGs. For the analysis, we selected more than two minutes of artifact-free EEG readings from the three-minute recordings
15798132|NCT04466605|Other|Tele-yoga therapy|Each session included combinations of different yoga exercises, postures, yoga breathing, yoga relaxation techniques, yoga counselling and meditative practices based on individualisation.
15798005|NCT04467658|Diagnostic Test|electroencephalography relative theta power|We used MATLAB 7.0.1 (Math Works, Natick, MA, USA) and the EEGLAB toolbox to pre-process and analyze the EEG recordings. First, the EEG data were down-sampled to 250 Hz. Next, the EEG data were detrended and mean-subtracted to remove the DC component. A 1-Hz high-pass filter and a 60-Hz notch filter were applied to remove eye and electrical noise. Next, independent component analysis (ICA) was performed to remove the well-defined sources of artifacts. ICA has been shown to reliably isolate artifacts caused by eye and muscle movements and heart noise (23). Finally, clinical psychiatrists and EEG experts visually inspected the corrected EEGs. For the analysis, we selected more than two minutes of artifact-free EEG readings from the three-minute recordings
15798006|NCT04467658|Diagnostic Test|electroencephalography absolute slow alpha power|We used MATLAB 7.0.1 (Math Works, Natick, MA, USA) and the EEGLAB toolbox to pre-process and analyze the EEG recordings. First, the EEG data were down-sampled to 250 Hz. Next, the EEG data were detrended and mean-subtracted to remove the DC component. A 1-Hz high-pass filter and a 60-Hz notch filter were applied to remove eye and electrical noise. Next, independent component analysis (ICA) was performed to remove the well-defined sources of artifacts. ICA has been shown to reliably isolate artifacts caused by eye and muscle movements and heart noise (23). Finally, clinical psychiatrists and EEG experts visually inspected the corrected EEGs. For the analysis, we selected more than two minutes of artifact-free EEG readings from the three-minute recordings
15798007|NCT04467658|Diagnostic Test|electroencephalography relative slow alpha power|We used MATLAB 7.0.1 (Math Works, Natick, MA, USA) and the EEGLAB toolbox to pre-process and analyze the EEG recordings. First, the EEG data were down-sampled to 250 Hz. Next, the EEG data were detrended and mean-subtracted to remove the DC component. A 1-Hz high-pass filter and a 60-Hz notch filter were applied to remove eye and electrical noise. Next, independent component analysis (ICA) was performed to remove the well-defined sources of artifacts. ICA has been shown to reliably isolate artifacts caused by eye and muscle movements and heart noise (23). Finally, clinical psychiatrists and EEG experts visually inspected the corrected EEGs. For the analysis, we selected more than two minutes of artifact-free EEG readings from the three-minute recordings
15798008|NCT04467658|Diagnostic Test|electroencephalography absolute fast alpha power|We used MATLAB 7.0.1 (Math Works, Natick, MA, USA) and the EEGLAB toolbox to pre-process and analyze the EEG recordings. First, the EEG data were down-sampled to 250 Hz. Next, the EEG data were detrended and mean-subtracted to remove the DC component. A 1-Hz high-pass filter and a 60-Hz notch filter were applied to remove eye and electrical noise. Next, independent component analysis (ICA) was performed to remove the well-defined sources of artifacts. ICA has been shown to reliably isolate artifacts caused by eye and muscle movements and heart noise (23). Finally, clinical psychiatrists and EEG experts visually inspected the corrected EEGs. For the analysis, we selected more than two minutes of artifact-free EEG readings from the three-minute recordings
15798009|NCT04467658|Diagnostic Test|electroencephalography relative fast alpha power|We used MATLAB 7.0.1 (Math Works, Natick, MA, USA) and the EEGLAB toolbox to pre-process and analyze the EEG recordings. First, the EEG data were down-sampled to 250 Hz. Next, the EEG data were detrended and mean-subtracted to remove the DC component. A 1-Hz high-pass filter and a 60-Hz notch filter were applied to remove eye and electrical noise. Next, independent component analysis (ICA) was performed to remove the well-defined sources of artifacts. ICA has been shown to reliably isolate artifacts caused by eye and muscle movements and heart noise (23). Finally, clinical psychiatrists and EEG experts visually inspected the corrected EEGs. For the analysis, we selected more than two minutes of artifact-free EEG readings from the three-minute recordings
15798010|NCT04467658|Diagnostic Test|electroencephalography absolute beta power|We used MATLAB 7.0.1 (Math Works, Natick, MA, USA) and the EEGLAB toolbox to pre-process and analyze the EEG recordings. First, the EEG data were down-sampled to 250 Hz. Next, the EEG data were detrended and mean-subtracted to remove the DC component. A 1-Hz high-pass filter and a 60-Hz notch filter were applied to remove eye and electrical noise. Next, independent component analysis (ICA) was performed to remove the well-defined sources of artifacts. ICA has been shown to reliably isolate artifacts caused by eye and muscle movements and heart noise (23). Finally, clinical psychiatrists and EEG experts visually inspected the corrected EEGs. For the analysis, we selected more than two minutes of artifact-free EEG readings from the three-minute recordings
15798011|NCT04467658|Diagnostic Test|electroencephalography relative beta power|We used MATLAB 7.0.1 (Math Works, Natick, MA, USA) and the EEGLAB toolbox to pre-process and analyze the EEG recordings. First, the EEG data were down-sampled to 250 Hz. Next, the EEG data were detrended and mean-subtracted to remove the DC component. A 1-Hz high-pass filter and a 60-Hz notch filter were applied to remove eye and electrical noise. Next, independent component analysis (ICA) was performed to remove the well-defined sources of artifacts. ICA has been shown to reliably isolate artifacts caused by eye and muscle movements and heart noise (23). Finally, clinical psychiatrists and EEG experts visually inspected the corrected EEGs. For the analysis, we selected more than two minutes of artifact-free EEG readings from the three-minute recordings
15798012|NCT04467658|Diagnostic Test|Korean ADHD rating scale|The KARS is a standardized screening tool for ADHD in Korean children and rating scale completed by the parents.
15798013|NCT04467658|Diagnostic Test|Korean Version of Diagnostic Interview Schedule for Children Version IV|The DISC-IV is a structured diagnostic tool that was developed for use in epidemiological studies in children and adolescents
15798014|NCT04467645|Other|reflexology|Reflexology is the stimulation of the reflex points in the hands and feet by massage, designed to provide relaxation and relief in the body.
15798015|NCT04467632|Other|Validation of the mobility assessment by IMU wearable sensors|"The validity of the mobility assessment by IMU wearable sensors will be verified in Work Package 3.
~It will be defined as the accuracy of the machine learning algorithm to predict patients' motor status compared to the motor status assessed at clinical examination by means of the MDS-UPDRS-III scale and the Fit test. Prediction by machine learning will be compared with the MDS-UPDRS-III total score and with the 3.14 item (global clinical impression of mobility) of the same scale.
~The patients will be asked to perform all the motor tasks of the MDS-UPDRS-III scale and the finger tapping test (Fit test) with both hands wearing the IMU system. A subset of minimal motor tasks allowing good prediction of the patient's motor status by the machine learning algorithm will then be selected for Work Package 4."
15798064|NCT04467164|Device|exhalatory-gated transcutaneous vagus nerve stimulation (e-RAVANS)|Non-painful exhalatory-gated electrical stimulation of the auricle for 30 minutes during a functional magnetic resonance imaging session.
15798016|NCT04467632|Other|Testing in real-life conditions at patients' home in a small group of subjects|"Baseline Phase B1: Observation phase: 1-week wrist actigraphy and sleep diary to assess habitual activity/rest routines.
~B2: Nocturnal sleep consolidation phase: 2 weeks: timed light exposure, constant sleep/wake routine and sleep restriction of 1 hour/night (based on habitual activity)."
15798017|NCT04467632|Other|Testing in real-life conditions at patients' home in a small group of subjects|"Intervention phase
~Phase A (11 days): subjects will receive one hour of morning and afternoon light exposure twice a day:
~Day #1: baseline assessment of outcome measures;
~Days #2 to #6: bright light in the morning (active treatment) + dim light in the afternoon (placebo), to progressively advance circadian phase of 30' per day (phase advance of 2.5 hours obtained at day 6);
~Days #7 to #11: dim light in the morning + bright light in the afternoon to revert the circadian phase to the baseline of 30' per day.
~Washout: 6 days. No intervention during this phase, to stabilise the reverted circadian rhythm to baseline, for phase B to be held at the same conditions as phase A.
~Phase B (11 days): similar as in phase A:
~Day #1: similar as in phase A;
~Days #2 to #6: reverted conditions compared to phase A.
~Days #7 to #11: reverted conditions compared to phase A."
15798018|NCT04467619|Device|Functional Proprioceptive Stimulation|Functional Proprioceptive Stimulations (FPS) are applied on the musculo-tendinous junction. FPS mechanically stimulate the muscle spindles, mimicking the sensory signals - Ia fibers of functional movements. This neurosensory trick activates related sensory-motor areas allowing patients to feel natural movements. Because sensory & motor systems are interdependent, the central nervous system then reacts by initiating corresponding movements.
15798019|NCT04467606|Behavioral|a discharge planning using the strategy of motivational interviewing|The experimental group will receive a discharge planning which use the strategy of motivational interviewing. The discharge planning will be provided individually at the following time points: before discharge, on post-discharge days 3, 7, 14, 21, 28, and then each month till one year.
15798020|NCT04467593|Device|Whole body hyperthermia device|Whole body hyperthermia to treat stage IV cancer patients
15798021|NCT04467593|Device|Whole body hyperthermia device with FOLFIRINOX or FOLFOX or gemcitabine/nab-paclitaxel or gemcitabine|Whole body hyperthermia to treat stage IV pancreatic cancer patients combined with standard of care chemotherapy
15798022|NCT04467580|Diagnostic Test|abdominal [18F]FDG PET/CT|Patients will have within a maximum period of 15 days before the surgery (resection of intestinal stenosis), records by MRI and by digital PET/CT with low injected activity of [18F]FDG, focused on the abdomen, the MRI will be performed maximum 30 days before the intervention (if available and performed according to the procedure for the study, it will not be repeated for the study).
15798023|NCT04467567|Other|Single Photon Emission Computed Tomography/ Computed Tomography (SPECT/CT)|SPECT/CT will be performed after Lutathera® treatment (at 24h, 96h and 168h after the infusion of Lutathera®) on the conventional camera and on the VERITON-CT camera
15798024|NCT04467554|Device|T-chair|Participants will receive 15 sessions of intervention, four weeks in total with a duration of one hour for each session. The focus of the intervention will be trunk rehabilitation.
15798025|NCT04467541|Biological|Inactivated Enterovirus Type 71 (EV71) Vaccine (Vero Cell)|Inactivated Enterovirus Type 71 (EV71) Vaccine safety in healthy adults followed by safety and immunogenicity administered in two consecutive doses, one-month apart among children aged 6 to 71 months
15798026|NCT04467528|Device|Electroacupuncture|"Experimental: Electroacupuncture combined with conventional drug therapy
~Conventional drug therapy:
~All participants receive intravenous infusion of metoclopramide(10mg) every 12 hours in the trial
~For participants with abdominal distension:
~Electroacupuncture will be applied to the acupoints (LI4, PC6, ST36, SP6) 30min
~For participants with post-operative ileus:
~Electroacupuncture will be applied to the acupoints (LI4, SJ6, ST36, ST37) 30min
~32# acupuncture needle used and twice daily for three days"
15798027|NCT04467528|Drug|Conventional drug therapy|"Conventional drug therapy:
~All participants receive intravenous infusion of metoclopramide(10mg) every 12 hours in the trial"
15798029|NCT04467502|Other|cognitive-behavioral therapy for gambling disorder|6 sessions of cognitive-behavioral therapy for gambling disorder
15798030|NCT04467502|Other|imaginal exposure therapy focus on gambling cues|6 sessions of imaginal exposure therapy focus on gambling cues
15798031|NCT04467502|Other|virtual reality exposure therapy focus on gambling cues|6 sessions of virtual reality exposure therapy focus on gambling cues
15798033|NCT04467476|Device|Transcranial direct current stimulation|Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation (NIBS) technique that has been investigated for the management of various health conditions. However, its ergogenic effect still has controversial results.
15798034|NCT04467463|Procedure|peripheral nerve block by 0.25% levobupivacaine|SUBMANDIBULAR nerve block will be performed using a 25G 90 mm beveled needle . the entry point of the needle will be situated at the angle formed by the superior edge of the zygomatic arch below and the posterior orbital rim forward .The needle will be inserted perpendicular to the skin and advanced approximately 20 mm depth to reach the greater wing of the sphenoid deep to the pterygopalatine fossa. Injection of 1ml of 0.25% levobupivacaine will be done over 20 seconds afterensuring negative blood aspiration .greater Palatine Nerve will be blocked bilaterally as it leaves on palatal side through the foramen on the opposite direction of the anterior part of the 3rd molar orthe posterior part of the 2nd molar tooth.
15798035|NCT04467450|Drug|botulinum toxin type A|ultrasound guided injection of the botulinum toxin type A in the inflamed subacromial subdeltoid bursa
15798036|NCT04467450|Drug|Methyl Prednisolonate|ultrasound guided injection of Methyl Prednisolonate in the inflamed subacromial subdeltoid bursa
15798037|NCT04467437|Other|Gait Training|Training that targets rehabilitation of walking function
15798038|NCT04467437|Device|Transcutaneous Spinal Stimulation|Non-invasive electrical stimulation of the spinal cord over the skin combined with gait training
15798039|NCT04467424|Drug|ketamine, propofol|anesthesia with ketofol in pediatric surgery
15798040|NCT04467424|Drug|ketamine, propofol, lidocaine|anesthesia with ketofol plus lidocaine in pediatric surgery
15798041|NCT04467398|Procedure|trigeminal nerve block|Trigeminal nerve or branch block using 22 gauge Quincke or Tuohy needle under fluoroscopic guidance.
15798042|NCT04467385|Other|VR training + Sensory Integration therapy + conventional therapy|"After the baseline assessment,
~Coconut ShootersVR - 5 min/day
~Ninja flipVR - 5 min/day.
~Sensory integration training include Exercises on BOSU ball and mini-trampoline. It will involve:
~Passive bouncing with child standing with his/her feet shoulder width apart for 2.5 and 2.5 minutes on both.
~Active bouncing (the child bounces and therapist will control the rate) for 2.5 and 2.5 minutes on both.
~Mini-squat exercises with feet apart and feet together for 2.5 and 2.5 minutes on both.
~Conventional exercises include:
~passive stretching exercises for the hip flexors, hip adductors, hamstring, and calf muscle; stretching will be applied for 30 sec with 30 sec rest for each muscle group within pain limit.
~Strengthening of abdominal and back muscles, hip abductions and knee joint extensors and ankle dorsiflexors will be performed."
15798043|NCT04467385|Other|VR training + conventional therapy|"After the baseline assessment,
~The Your Shape: Fitness Evolved 2012TM game is selected for VR training (walking and walking with obstacles) for 8 min
~Coconut ShootersVR - 8 min/day
~Ninja flipVR - 8 min/day
~Conventional Therapy - 20 min per day
~Passive stretching exercises for the hip flexors, hip adductors, hamstring, and calf muscle; stretching will be applied for 30 sec with 30 sec rest 3-5 times for each muscle group within pain limit.
~Strengthening of abdominal and back muscles, hip abductions and knee joint extensors and ankle dorsiflexors will be performed."
15798044|NCT04467372|Dietary Supplement|Tart cherry juice concentrate|Two 8oz bottles of tart cherry juice concentrate daily for 30 days
15798045|NCT04467372|Dietary Supplement|Juice placebo|Two 8oz bottles of placebo juice daily for 30 days
15798046|NCT04467372|Dietary Supplement|Freeze dried tart cherry powder|Two freeze dried tart cherry powder capsules daily for 30 days
15798047|NCT04467372|Dietary Supplement|Capsule placebo|Two placebo capsules daily for 30 days
15798048|NCT04467359|Other|ERAS|Optimize physical conditions; Fasting solid diet 6h before surgery, fasting clear fluid 2 h before surgery; If there is no chief complaint of dizziness, nausea or other discomfort after the operation, warm water (no more than 100ml) can be immediately drunk. Pain management; Encourage patients to engage in early activities under the premise of effective pain control; If no dural puncture and other complications occur, the patient has no chief complaints of headache, dizziness, nausea and other discomfort, and there is no need to lie supine, the comfortable position such as semi-supine lateral supine position can be taken immediately (avoid 90-degree upright position for patients with hip joint); Prevention of thrombosis; Prevention and treatment of nausea and vomiting; Follow-up was conducted at 4 weeks, 8 weeks and 12 weeks after the operation.
15798049|NCT04467359|Other|Perioperative routine rehabilitation nursing|Fasting and water deprivation at 12 o 'clock on the first day before surgery; Fasting water 6-8 hours after surgery; Lie flat on your pillow for 6 hours; Get out of bed activity 1 day after operation
15798050|NCT04467346|Drug|Ped-TMZ|Ped-TMZ will be administered using the provided dosing oral syringes and followed by a glass of 240 ml of water (for mouth rinsing) in sitting position and under fasting condition for at least 8 hours before dosing
15798051|NCT04467333|Other|All lung cancer patients.|There will be no specific interventions. All patients will receive guidelines based therapy of lung cancer and their comorbidities.
15798052|NCT04467320|Behavioral|Teaching Recovery Techniques|Teaching Recovery Techniques is a 7-session group programme, with 5-sessions for the young person and 2-sessions for the carer. All sessions will be held online. The carer sessions are focused on psychoeducation around trauma and PTSD, as well as skills for supporting a young person through the intervention and with PTSD symptoms more broadly. The young person sessions are primarily focused on skill building and include: psychoeducation and understanding intrusive memories; intrusive images, worries and dreams; arousal, emotions, relaxation and coping; avoidance and triggers; and, memories.
15798053|NCT04467320|Behavioral|Care as usual|In the care as usual arm, social workers will follow their standard care protocol for young people experiencing psychological distress. A typical response may include a referral to either the specialist local CAMHS or general CAMHS.
15798054|NCT04467307|Device|Rigit bronchoscopy|After general anesthesia, the airway is checked with a rigid bronchoscope suitable for the age. If there is a foreign body, it is removed by forceps.
15798055|NCT04467281|Drug|89Zr-DFO-daratumumab|Patients will undergo 89Zr-DFO-daratumumab PET/CT once before standard of care therapy and once again afterward, for a total of two research scans.
15798056|NCT04467281|Diagnostic Test|PET/CT|Patients will undergo 89Zr-DFO-daratumumab PET/CT once before standard of care therapy and once again afterward, for a total of two research scans.
15798057|NCT04467268|Behavioral|Sleep extension|The sleep extension programme was designed around four alternative assumptions: 1) that among this group of habitual short sleepers, extending time in bed (TIB) would represent a significant behavioral change to established night-time and daytime routines; 2) that for practical purposes (accommodating personal, family and work schedules) extended time in bed is best anchored against typical rise-times; 3) that sleep onset may represent a particular challenge for those advancing habitual bed-times by over 1 hour each night; and 4) that in consenting to the trial, participants were motivated to make and sustain behavioral change.
15798058|NCT04467255|Other|Rehabilitative training|4 weeks aerobic treadmill training compared to endurance training with elastic thera band
15798059|NCT04467229|Behavioral|Focus group|5 to 10 adolescents will participate in a discussion group lead by a paediatrician and a psychologist from the Centre de la Douleur de Trousseau. Two groups will be organized, the length of the group discussion being one hour. These focus groups will explore the adolescents' perception of the questionnaire and of different elements of the screening. The group will undergo full transcription. The verbatim will be anonymous and will be analysed through qualitative methods.
15798060|NCT04467216|Device|Computerised cognitive training using virtual reality|Immersive VR training system tailor-made for the daily living experiences in the Hong Kong context to provide interactive experiences for older people in Hong Kong.The VR systems available in the market for older people are only for non-interactive activities (e.g., watching movies) to provide unusual experiences for disabled older people who cannot travel too far from home.
15798061|NCT04467203|Drug|Fadanafil|"Seven subjects in group A will receive treatment in the following order:
~At Day 1, a single dose of Fadanafil 100mg will be administered orally after overnight fasting->
~At Day 8, a single dose of Fadanafil 100mg will be administered orally with high fat meal;Seven subjects in group B will receive treatment in the following order:
~At Day1, a single dose of Fadanafil 100mg will be administered orally with high fat meal-> At Day 8, a single dose of Fadanafil 100mg will be administered orally after overnight fasting"
15798065|NCT04467164|Device|Inhalatory-gated transcutaneous vagus nerve stimulation (i-RAVANS)|Non-painful inhalatory-gated electrical stimulation of the auricle for 30 minutes during a functional magnetic resonance imaging session.
15798066|NCT04467151|Drug|anti-SARS-CoV-2 plasma|Administration of anti-SARS-CoV-2 convalescent plasma
15798067|NCT04467151|Other|Placebo|Administration of placebo (albumin 5%)
15798068|NCT04467138|Drug|Omegaven|Pure fish oil emulsion (Omegaven®, Fresenius Kabi) was used as the additional product along with the standard lipid emulsion to reach a fish oil dose of approx. 0.5 g fish oil/kg/d.
15798069|NCT04467125|Drug|Eutectic Lidocaine Prilocaine|Subjects randomized to EMLA receive one inch of EMLA cream placed at the removal site and then have an occlusive dressing placed. One hour later they have the Nexplanon device removed.
15798070|NCT04467125|Drug|Subcutaneous Lidocaine|Subjects randomized to subcutaneous lidocaine have 1% lidocaine injected by the provider at the removal site in an amount decided on by the provider.
15798071|NCT04467112|Device|Breath Biopsy face masks with removable filters and fitted PVA strip|Device developed for collection of breath samples
15798072|NCT04467099|Other|Foot Exam Follow-Up|All participants will have a clinical assessment of their surgery foot by the study doctor.
15798073|NCT04467099|Radiation|X-ray|Standard x-ray of the foot.
15798074|NCT04467099|Other|Questionnaire|All participants will complete a questionnaire.
15798075|NCT04467086|Drug|Propranolol Hydrochloride|"Propranolol enterally at a starting dose of 20mg every 6h for 2-4 doses, and then re-assessed for upwards titration every 24 hours (+/- 6 hours) at 10mg dose increases depending on clinical response. Maximum dose of 60mg every 6h. Titration decision to be made by clinical team at daily rounds.
~Daily titration will be guided by hemodynamic markers indicative of the expected sympatholysis from propranolol. Upward titration of propranolol should coincide with a downward titration in sedatives until a minimum level of sedative infusion is reached (propofol <0.5mg/kg/h or midazolam <1.0mg/h). Nurses will be instructed at each assessment to determine if sedative targets can be achieved with lower doses of sedatives. Daily upward titration of propranolol will be recommended if none of these conditions are met: (1)HR<70 beats/min, (2) Mean Arterial Pressure <70 mmHg or (3) norepinephrine or equivalent vasopressor dose increase to >0.15 mcg/kg/min."
15798076|NCT04467073|Behavioral|Online RIT|"Online RIT presents RIT techniques in four sequential learning modules: (1) Setting Up For Success (2) Imitating your Child (3) Describing Play (4) Teaching Object Imitation. Each learning module includes an instructional video, quiz, interactive exercises, and at-home planning and reflection. The website also includes a video library, Frequently Asked Questions, downloadable visual aids, links to relevant external resources, and a customizable dashboard that allows users to track their individualized goals and the amount of time they have spent working on their goals (e.g., practice log)."
15798077|NCT04467060|Drug|Anaprazole Sodium|2.5mg, 5mg, 10mg, 20mg, 40mg, 80mg, 120mg, 160mg，fasting oral administration.
15798078|NCT04467060|Drug|Placebo|single dose, fasting oral administration
15798079|NCT04467047|Biological|Mesenchymal Stromal Cells infusion|Intravenous 1*10E6 MSCs/kg body weight Mesenchymal Stromal Cells infusion
15798080|NCT04467034|Behavioral|Stanford Tobacco Prevention Toolkit curriculum|Stanford Toolkit curriculum delivered as a 5-session course in a school classroom setting.
15798081|NCT04467021|Other|Best Practice|Receive usual blood pressure management
15798082|NCT04467021|Other|Blood Pressure Measurement|Undergo blood pressure measurement
15798083|NCT04467021|Other|Clinical Management|Undergo intensive systolic BP management
15798084|NCT04467021|Other|Quality-of-Life Assessment|Ancillary studies
15798085|NCT04467021|Other|Questionnaire Administration|Ancillary studies
15798086|NCT04466995|Device|manometer|cuff pressure to be measured with manometer
15798087|NCT04466956|Device|Virtual reality|Virtual reality headset worn with short relaxing video played during MVA procedure
15798088|NCT04466943|Device|Neuromuscular transmission monitoring (NMT)|NMT is to monitor the depth of neuromuscular blockade intensity
15798089|NCT04466917|Drug|ABP 215|ABP 215 will be administered at a dose of 15 mg/kg IV
15798090|NCT04466917|Drug|Bevacizumab|Bevacizumab will be administered at a dose of 15 mg/kg IV
15798091|NCT04466917|Drug|Paclitaxel|Paclitaxel will be administered 175 mg/m2 IV
15798092|NCT04466917|Drug|Carboplatin|Carboplatin will be administered at an area under the concentration-time curve (AUC) of 5 IV
15798093|NCT04466904|Drug|IBI362|Administrated by subcutaneous injection
15798094|NCT04466904|Drug|Placebo|Administrated by subcutaneous injection
15798095|NCT04466904|Drug|Dulaglutide|Administrated by subcutaneous injection
15798096|NCT04466891|Drug|ZW25 (Zanidatamab)|Administered intravenously
15798097|NCT04466891|Diagnostic Test|In situ hybridization (ISH)-based companion diagnostic assay|Subjects will be tested for HER2 gene-amplification using the ISH-based companion diagnostic assay
15798098|NCT04466891|Diagnostic Test|Immunohistochemistry (IHC)-based companion diagnostic assay|Subjects will be tested for HER2 protein-expression using the IHC-based companion diagnostic assay
15798099|NCT04466865|Other|Best Case/Worst Case communication tool training|"The communication tool promotes dialogue and patient deliberation, and supports shared decision making in the context of kidney disease. Building on a conceptual model of shared decision-making proposed and the practice of scenario planning the intervention is designed to lead to a discussion of participants preferences and consideration of outcomes.
~The nephrologist verbally describes the best case, worst case, and most likely outcomes for each treatment option-incorporating rich narrative from clinical experience and translation of probabilistic information-while drawing a diagram of those options. The nephrologist also writes details about each option on the diagram. The narrative and graphic help family and patients formulate and express preferences."
15798125|NCT04466657|Other|Standard of Care|SOC will be as determined by the clinical team at the treatment centres in line with the current National Interim Guidelines for Clinical Management of COVID-19
15798126|NCT04466644|Diagnostic Test|ELISA|Antibody test (serology) in the blood samples to determine if the subject was previously infected.
15798127|NCT04466644|Diagnostic Test|RT-PCR|For detecting the presence of SARS-CoV-2 RNA molecule in the nasopharyngeal swabs and saliva.
15798128|NCT04466618|Biological|Saline|Saline infused during the study
15798129|NCT04466618|Biological|Exendin-9,39|Exendin-9,39 infused during the study
15798100|NCT04466852|Other|telemedicine-guided consultation|Educational material is provided as short audiovisual films for understanding heart failure condition and management, how medicines work and their side effects, general advise on diets, exercise and importance of refraining from toxic exposure (smoke, alcohol, narcotics and damaging illegal medicines). Additionally, the patient (eventually assisted by their relatives and caregivers) can use this platform for learning basic important warning signs or cardiac decompensation based on feedback on recording regular measurements (weight, blood pressure and pulse and blood tests when needed) and symptoms. The cardiologist guides the patient and their Family/Basic doctors on the need for follow-up based on the parameters recorded. Videoconsultations with participation of the cardiologist, the Family/Basic doctor and the patient and relatives are used on demand.
15798101|NCT04466839|Other|Questionnaire and interview|The questionnaires are Parkinson Disease Questionnaire-8 Items (PDQ-8) Visual Analog Scale (VAS) is visual analog scale visual numeric from 0 to 100, Neuropsychiatric Inventory-Questionnaire-Reduced (NPI-R) and Clinical Global Impression-Impairment (CGI-I).
15798102|NCT04466826|Other|Headache Journal|Phase 1 of study to determine a baseline for headache frequency, headache intensity and medication usage patterns
15798103|NCT04466826|Drug|Sphenopalatine Block|Phase 2 of study providing medication using 0.3ml of 0.5% Bupivacaine per nares delivered intranasal via the Tx360 device
15798104|NCT04466826|Device|Tx360|Phase 2 of study providing medication using 0.3ml of 0.5% Bupivacaine per nares delivered intranasal via the Tx360 device
15798105|NCT04466813|Device|Intervention-Dry Needling|"Deep Dry Needling into the site of the latent Trigger Point of the upper trapezius muscle.
~1 session in upper trapezius muscle moving the needle up and down ten times."
15798106|NCT04466813|Device|Control-Dry Needling|Sham Dry Needling into the site of the latent Trigger Point of the upper trapezius muscle with non-penetrating needles
15798107|NCT04466800|Other|Intervention group_rehabilitation program|"Regular physical activity, supervised by a physical education educator, a systematic malnutrition screening and a nutritional follow-up performed by a dietetician.
~Patients will follow a 4-week rehabilitation program, comprising 3 physical activity sessions per week for 4 weeks. First sessions will be supervised by a physical activity educator and patients will perform the following sessions at home, using physical training software. The physical activity educator will call patients once a week to ensure the sessions are correctly performed and adapt the program if necessary. Patients will also undergo a nutritional assessment carried out by a dietitian at the beginning of the program. A dietitian will call patients once a week to ensure their nutritional status is appropriate."
15798108|NCT04466787|Diagnostic Test|Spectral Photon Counting Computed Tomography (SPCCT)|"The acquisition for the assessment of the brain parenchyma and for the evaluation of the cervical and intracranial arteries will be performed without and with iodine based contrast media, respectively. The same parameters will be used for both conditions but for a large volume, from the aortic arch to the top of the head. The iodinate contrast agent's injection (Iomeron 400, Bracco Imaging France) will be performed at 5mL/s into an 18G catheter, followed by a 20 mL saline flush that will be injected at the same rate. The bolus volume will be determined according to the patient's body weight : 70 mL for patients < 80 kg and 1 mL/kg for patients > 80 kg, with a maximum of 90 mL.
~The SPCCT scanner is a prototype spectral photon-counting computed tomography system derived from a modified clinical CT system with a field of View (FOV) of 168 mm in-plane, and a z-coverage of 2 mm."
15798109|NCT04466787|Diagnostic Test|Dual Energy CT (DECT)|"The acquisition for the assessment of the brain parenchyma and for the evaluation of the cervical and intracranial arteries will be performed without and with iodine based contrast media, respectively. The same parameters will be used for both conditions but for a large volume, from the aortic arch to the top of the head. The iodinate contrast agent's injection (Iomeron 400, Bracco Imaging France) will be performed at 5mL/s into an 18G catheter, followed by a 20 mL saline flush that will be injected at the same rate. The bolus volume will be determined according to the patient's body weight : 70 mL for patients < 80 kg and 1 mL/kg for patients > 80 kg, with a maximum of 90 mL.
~DECT : IQon, Philips"
15798110|NCT04466774|Diagnostic Test|Dip Home-Based Dipstick Analyzer|The Dip Home-Based Dipstick Analyzer is a prescription, in-vitro diagnostic, home use device, which qualitatively and semi-quantitatively measures six urine analytes. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm.
15798111|NCT04466774|Device|Urine analysis predicate device for professional user|Results of the experimental HBDA device will be compared to the results of the predicate device tested by a professional user.
15798112|NCT04466761|Dietary Supplement|Monosaccharide Powder|Monosaccharide powder dissolved in water.
15798113|NCT04466761|Other|Placebo Comparator|Placebo (cellulose powder).
15798114|NCT04466748|Drug|Anaprazole Sodium enteric-coated tablet|Multiple ascendinng dose, anaprazole 20mg QD(20mg QD group), 40mg QD(40mg QD group), 20mg Bid(20mg Bid group) , 6 days, fasting oral administration.
15798115|NCT04466748|Drug|Placebo|Multiple dose, 1 tablet QD (20mg QD and 40mg QD group), 1 tablet Bid (20mg Bid group), 6 days, fasting oral administration.
15798116|NCT04466735|Dietary Supplement|Active group|2 x 12 g of EKS/day
15798117|NCT04466735|Dietary Supplement|Placebo group|Isocaloric placebo supplement with similar salt load but no EKS
15798118|NCT04466709|Other|none intervention type|This is an observational study, no intervention
15798119|NCT04466696|Behavioral|ERAS protocol|items of ERAS protocol applied
15798120|NCT04466683|Radiation|Low dose radiation 35 cGy|A dose of 35 cGy of whole thorax irradiation will be delivered at a single timepoint
15798121|NCT04466683|Radiation|High dose radiation 100 cGy|A dose of 100 cGy of whole thorax irradiation will be delivered at a single timepoint
15798122|NCT04466670|Drug|acetylsalicylic acid|acetylsalicylic acid (ASA) 100 mg daily PO up to 14 days OR arterial oxygen saturation greater than or equal to 92% on room air OR PaO2 to FiO2 ratio greater than 200 for 2 consecutive days, whichever is first.
15798123|NCT04466670|Drug|Unfractionated heparin nebulized|unfractionated heparin - 25,000 U/ 5 ml nebulized inhalation every 6 hours up to 14 days OR arterial oxygen saturation greater than or equal to 92% on room air OR PaO2 to FiO2 ratio greater than 200 for 2 consecutive days, whichever is first.
15798124|NCT04466657|Dietary Supplement|Antioxidation Therapy|Two proprietary formulations composed of reduced glutathione, N-acetylcysteine, superoxide dismutase, and bovine lactoferrin and immunoglobulins.
15798130|NCT04466618|Biological|Saline + Intralipid/Heparin|Saline infused during acute insulin resistance
15798134|NCT04466592|Behavioral|Promotion of competences of participant involved in the management of the post operative period|The research psychologist will be in touch with the participants for 9 months after the surgery (weekly, biweekly or monthly) in order to help them recovering social and work activities, and dealing with the consequences of the surgery. Specifically, four competences will be promoted (future forethought; context evaluation; consequences of own actions forethought; use of available resources), each relevant to four areas (clinical; familiar; working; daily-activities).
15798135|NCT04466579|Other|BIS monitor|BIS monitor is used to control and monitor the depth of general anesthesia.
15798136|NCT04466579|Other|Standard care|Standard anesthesiology care according to the protocol of the study
15798137|NCT04466566|Other|Saline|Saline will serve as the control
15798138|NCT04466566|Biological|Exendin-9,39|Exendin-9,39 will block the GLP-1 receptor
15798139|NCT04466553|Device|NICO BrainPath™ System|Patients who are admitted under the neurology service in the Neurocritical Care and Medical ICU will be screened for participation in the trial by their treating physician. Once blood pressure has been stabilized and the best medical treatment has been determined, the patient will need to undergo a standard of care, repeat CT scan 6 hours after stabilization to show that there has been no increase in size of the ICH. Patients that meet eligibility criteria after this CT will be taken to the OR within 24-72 hours for a minimally invasive, navigation guided endoport based evacuation of the clot using the NICO BrainPath™ system.
15798140|NCT04466540|Drug|Hydroxychloroquine|Hydroxychloroquine pharmaceutical form will be tablets of 400 mg.
15798141|NCT04466540|Drug|Placebo|Hydroxychloroquine placebo
15798142|NCT04466527|Device|Laser Intervention|Subjects with undergo laser exposure of their active acne vulgaris.
15798143|NCT04466514|Drug|ASTX029|Form: tablet; Route of Administration: oral
15798144|NCT04466501|Device|ACR LAB|"The ACR | LAB is a prescription-only, nurse- or clinician-conducted in vitro diagnostic (IVD) device. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm."
15798145|NCT04466488|Behavioral|Choice Architecture|"Providers will receive general training on TPT benefits, indications, and contra-indications.
~Providers will be provided with updated ART and TPT prescribing approach, including an ink stamp or pre-printed sticker for quick entry of the ART prescription along with TPT and cotrimoxazole.
~The pharmacy or clinician (if the clinician dispenses) will dispense ART, cotrimoxazole, and TPT as prescribed"
15798149|NCT04466449|Diagnostic Test|stool sample|A stool sample will be collected from each patient for diagnosis of Entamoeba
15798150|NCT04466436|Other|tryptophan|measurement of tryptophan in serum
15798151|NCT04466423|Behavioral|Small group meetings (COMPASS: COlleagues Meeting to Promote And Sustain Satisfaction)|The first 15 minutes of each session will be semi-structured discussion involving i) check in and ii) dialogue about the assigned question. Group leaders will be provided 3-4 discussion questions for each session. The group (or the leader) can choose the one they are most interested in and will then spend 10-15 minutes discussing the question together. Questions will touch on key themes for discussion (see the attached topics list) and are derived from our previous intervention studies. The remainder of the time can be used for socializing and building relationships with colleagues.
15798154|NCT04466397|Device|3D printed individualized porous implants|Use 3D printed individualized porous implants to reconstruct the large bone defects caused by tumor, infection or trauma.
15798155|NCT04466384|Device|BIS|Subjects will be sequentially assigned to the propofol or propofol and remifentanil group. The purpose is to capture the BIS value in association with these anesthetics.
15798156|NCT04466371|Other|Questionnaire|A questionnaire to assess satisfaction with online learning and knowledge about COVID-19
15798157|NCT04466358|Procedure|Modified CLOSE protocol|Modified CLOSE protocol guided isolation of pulmonary veins.
15798158|NCT04466358|Procedure|High density mapping guided pulmonary vein isolation|Modified CLOSE protocol guided isolation of pulmonary veins with additional ablations at sites of gaps or dormant conduction as evidenced by high density mapping of pulmonary vein antra.
15798159|NCT04466345|Biological|Semaglutide|3 mg/day for 4 weeks, increased to 7 mg/day for 4 more weeks and titrated to 14 mg/day for the subsequent 8 weeks
15798160|NCT04466345|Biological|Placebo|Semaglutide placebo capsules
15798161|NCT04466332|Device|LifeCath-CT PICC easy™ (Vygon)|"ECG electrodes are placed on patient's chest ensuring that there is a distinguishable P-wave.
~Upper arm selection is based on vein diameter and dominance, ultrasound is used to identify a suitable vein.
~The patient is prepared using a maximal sterile barrier approach. The catheter is inserted into one of the veins (75-90° arm abduction) using ultrasound and modified Seldinger technique.
~The PICC is advanced into the central circulation and used as an intracavitary electrode (connection with Vygocard2™). Saline water instilled through the catheter ensures conductivity.
~The ECG is then used until displayed intracavitary P-wave has a maximal height without negative deflexion. Catheter is left at this point (cavo atrial junction).
~The PICC hub side is then trimmed and the catheter part connected. The PICC is caped with a neutral bidirectional valve.
~The puncture site is dressed and catheter stabilized. Chest Xray is obtained immediately after insertion to assess the position."
15798162|NCT04466332|Device|PowerPICC-SOLO® (C.R. Bard)|"ECG electrodes are placed on patients chest ensuring that there is a distinguishable P-wave.
~Upper arm selection is based on vein diameter and dominance, ultrasound is used to identify suitable vein.
~The patient is prepared using a maximal sterile barrier approach. The catheter is inserted into one of the veins (75-90° arm abduction) using ultrasound and modified Seldinger technique.
~The catheter's free end is cut to the anticipated length using anthropometric measurements (insertion/axillary crease+axillary crease/sternal notch+13cm) and the preloaded magnetic-tipped stylet (serving as intracavitary electrode) is put inside.
~The PICC is advanced into central veins until intravascular ECG displays a P-wave with maximal height without negative deflexion. Catheter is left at this point (cavo atrial junction).
~The puncture site is dressed and catheter stabilized. Chest Xray is obtained immediately after insertion to assess position."
15798487|NCT04463654|Device|Zero Self-Harm app|Safety plan app for smartphones
15798163|NCT04466319|Other|Rocking Chair|Patients in the experimental group were sat rocking chair three times a day in a rocking wooden chair in addition to their postoperative routine care by their nurses. After providing the rocking chair to the patients' room, the researcher gave the data collection form to be filled by the patient himself. It was the researcher's supervision that the patient sat in the rocking chair for the first time. The rocking chair movement continued to intervene until the patient released gas. After emitting gas, he continued to swing in the rocking chair until he made his first stools. The patient was visited every day until he was discharged. No special clothing or materials were required for the patients to sit in the rocking chair.
15798164|NCT04466293|Behavioral|Choice Architecture|"Providers will receive general training on TPT benefits, indications, and contra-indications.
~Providers will be provided with updated ART and TPT prescribing approach. This will be adapted to the country context and may include a pre-printed prescription pad (Mozambique), adaptations in clinical stationary (Zimbabwe), or adaptations to an electronic prescribing system (Malawi).
~The pharmacy or clinician (if the clinician dispenses) will dispense ART, cotrimoxazole, and TPT as prescribed"
15798165|NCT04466280|Drug|Hydroxychloroquine|200 mg of hydroxychloroquine daily for participants in the intervention group 1
15798166|NCT04466280|Drug|Mucodentol|Intervention Group 2 participants will place a thin layer of Dentol gel in the vestibular area of the mouth every 6 to 8 hours.
15798167|NCT04466280|Device|Personal protective equipment|Personal protective equipment such as masks, gloves, protective shields
15798168|NCT04466254|Drug|CPGJ602|Q2W/QW iv
15798169|NCT04466254|Drug|cetuximab|QW iv
15798170|NCT04466241|Drug|Lopinavir/Ritonavir 200 MG-50 MG Oral Tablet|2 tablets morning and evening from Day 1 to Day 10
15798171|NCT04466241|Drug|Telmisartan 40Mg Oral Tablet|1 tablet daily from Day 1 to Day 10
15798172|NCT04466241|Drug|Atorvastatin 20 Mg Oral Tablet|1 tablet daily from Day 1 to Day 10
15798173|NCT04466228|Device|non-invasive transcranial electrical stimulation|Non-invasive transcranial electrical stimulation across the prefrontal cortex.
15798174|NCT04466215|Drug|CORT118335|900 mg (6 x 150 mg) tablets taken orally once daily for one week
15798175|NCT04466215|Drug|Placebo oral tablet|Six placebo tablets taken orally once daily for one week
15798176|NCT04466202|Other|Music with Structured Verbal Training|Structured verbal training on prostate biopsy was given to the intervention group before the procedure, and then patients in this group listened to the music they preferred during the procedure with headphones.
15798177|NCT04466176|Drug|Test Product|2 inhalations of Test and Reference product in each study period
15798178|NCT04466176|Drug|Reference Product|2 inhalations of Test and Reference product in each study period
15798179|NCT04466163|Behavioral|Schema Therapy and the Healthy Adult|The protocol 'Schematherapy and the Healthy Adult' (ST-HA, Broersen & Claassen, 2019) is a direct intervention meant to strengthen patients' healthy adult functioning by developing compassion and care for well-being in the face of (childhood) adversity.
15798180|NCT04466150|Drug|Ocrelizumab|open label biomarker study
15798181|NCT04466137|Drug|YPEG-rhG-CSF|YPEG-rhG-CSF 2mg, single s.c. at day 3 of each cycles, up to 4 cycles. 21 day one cycles.
15798182|NCT04466137|Drug|YPEG-rhG-CSF|YPEG-rhG-CSF 33μg/kg, single s.c. at day 3 of each cycles, up to 4 cycles. 21 day one cycles.
15798183|NCT04466137|Drug|rhG-CSF/PEG-rhG-CSF|rhG-CSF 5μg/kg/day, s.c. from day 3 to day 14 or until neutrophils recover to exceed 5.0×10^9 cells/L, whichever comes first, in the first cycle. Patient can still continue rhG-CSF 5μg/kg/day, or covert to PEG-rhG-CSF 6mg/Cycle in the following 2-4 cycle. 21 day one cycles.
15798184|NCT04466124|Radiation|Liver Cancer Patients Treated With Proton Beam Therapy|Proton Beam Therapy
15798185|NCT04466111|Device|Intellis neurostimulator system|The study will use the commercially available IntellisTM neurostimulator and compatible SCS system components from Medtronic using stimulation parameters within the specifications approved for use in the approved indications. The study will stimulate the cervical dorsal columns of the spinal cord.
15798186|NCT04466098|Biological|Mesenchymal stromal cells|Thawed product containing MSC(300x10^6) in DMSO resuspended 1:1 with Dextran 40 + 5% human serum albumin [total volume 60 mL]
15798187|NCT04466098|Other|Placebo|Dextran 40 + 5% human serum albumin [total volume 60 mL]
15798188|NCT04466085|Biological|Recombinant new coronavirus vaccine (CHO cell) low-dose group|Intramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
15798189|NCT04466085|Biological|Recombinant new coronavirus vaccine (CHO cells) high-dose group|Intramuscular injection of deltoid muscle of upper armof 50μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
15798190|NCT04466085|Biological|Recombinant new coronavirus vaccine (CHO cells) placebo group|Intramuscular injection of deltoid muscle of upper armof 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
15798191|NCT04466072|Diagnostic Test|Stool test for microbial analysis|Fecal samples will be analyzed by shotgun metagenomics and sample from the high ventricular arrhythmia burden will be compared with those from comparable control patients with low ventricular arrhythmia burden.
15798192|NCT04466059|Diagnostic Test|Automated AI-Guided Diagnosis of Hematological Malignancies|In BELUGA, we want to investigate whether the automated analysis of blood (from peripheral blood and bone marrow aspirates) smears and flow-cytometry-based analyses can provide a benefit for diagnostic quality and, ultimately, patient care.
15798193|NCT04466046|Drug|midazolam, ramosetron|Intravenous midazolam 0.05mg/kg is given to the patients before anesthesia induction. Ramosetron 0.3mg is received 10 minutes before surgery in MR group.
15798194|NCT04466046|Drug|midazolam, palonosetron|Intravenous midazolam 0.05mg/kg is given to the patients before anesthesia induction. Palonosetron 0.075mg is received immediately before anesthesia in MP group.
15798195|NCT04466033|Device|Magneto Microcatheter|All patients will be treated with Magneto Microcatheter
15798196|NCT04466020|Other|Qualitative research interviews to be conducted|None. Qualitative research interviews to be conducted
15798197|NCT04466007|Drug|High dose allogeneic mesenchymal stromal cells|Allogeneic mesenchymal stromal cells derived from adipose tissue administered intramuscularly
15798198|NCT04466007|Drug|Low dose allogeneic mesenchymal stromal cells|Allogeneic mesenchymal stromal cells derived from adipose tidssue administeres intramuscularly
15798199|NCT04466007|Drug|Placebos|0,9% physiological saline
15798200|NCT04465994|Procedure|gastrocnemius turn-down flaps|We classified the patients with acute achilles tendon rupture by type of surgery. The group who received the gastrocnemius turn-down flaps is the intervention group.
15798201|NCT04465981|Diagnostic Test|Sampling|Test is to validate the utility of INanoBio's automated protein arrays in detecting antibodies against SARS-CoV-2 proteins.
15798202|NCT04465968|Drug|Cisplatin|Cisplatin 60 mg/m2, IV, day 1
15798203|NCT04465968|Drug|S1|80 - 120 mg/day, PO, day 1-14
15798204|NCT04465968|Radiation|concurrent radiotherapy|66 Gy/33 Fr
15798205|NCT04465968|Drug|Durvalumab|preoperative durvalumab therapy within 28 days after chemoradiotherapy. Two courses are given every two weeks.
15798206|NCT04465968|Procedure|Surgery|Surgery will be performed between day 15 and day 42 of the second course of preoperative durvalumab therapy after confirming that all surgical operation criteria are met.
15798207|NCT04465968|Drug|Durvalumab|"(For resectable SST) Postoperative durvalumab therapy will be started between day 28 and day 63 with the day of surgery as Day 1. Twenty-two courses are given as a 2-week course.
~Drug: Durvalumab 10 mg/kg/body, IV, day 1 (For unreectable SST) Additional durvalumab therapy between day 15 and day 28 of the second course of preoperative durvalumab therapy.
~Twenty-two courses are given as 2-week course. Drug: Durvalumab 10 mg/kg/body, IV, day 1"
15798208|NCT04465955|Biological|NGM621|NGM621 Dose 1
15798209|NCT04465955|Biological|NGM621|NGM621 Dose 2
15798210|NCT04465955|Other|Sham Comparator|Sham Comparator
15798211|NCT04465942|Drug|(chemo)immunotherapy|Patients are receiving immunotherapy or chemoimmunotherapy as a standard of care
15798212|NCT04465929|Biological|Autologous Human Schwann Cells|Schwann cells harvested from the sural nerve and debrided, injured sciatic nerve of the participant will be autologously transplanted along sural nerve autografts wrapped in a collagen matrix
15798213|NCT04465916|Drug|EYP001a|Oral tablets
15798214|NCT04465916|Drug|Placebo|Oral tablets
15798215|NCT04465916|Drug|Entecavir|Oral tablets
15798216|NCT04465916|Drug|Tenofovir Disoproxil|Oral tablets
15798217|NCT04465903|Other|Turkish Version of Sydney Swallow Questionnaire|The Turkish Version of Sydney Swallow Questionnaire consists of 17 questions related with dysphagia.
15798218|NCT04465890|Drug|ASC22|200mg/1ml/1bottle
15798219|NCT04465890|Drug|sodium chloride|90mg/10ml/1 bottle
15798220|NCT04465877|Drug|JTT-662|Active drug tablets containing JTT-662
15798221|NCT04465877|Drug|Placebo|Placebo tablets matching in appearance to the active drug tablets
15798222|NCT04465864|Drug|Intracanalicular Dexamethasone, 0.4 mg insert|Intracanalicular Dexamethasone, 0.4 mg insert four days (+/- 1 day) prior to surgery or inserted the day of surgery.
15798223|NCT04465851|Dietary Supplement|Ferrous Sulphate 65 mg|"Oral ferrous salt supplement Ferrous Sulphate 200 mg (equiv. 65 mg elemental iron content)
~Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach)
~At the mid-point visit day (day 21) and the finally at the end-point (day 42) compliance will be verified by counting capsules"
15798224|NCT04465851|Dietary Supplement|Curcumin|"HydroCurc™ 500 mg formulated curcumin
~At the mid-point visit day (day 21) and the finally at the end-point (day 42) compliance will be verified by counting capsules
~Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach)"
15798225|NCT04465851|Other|Placebo (Ferrous Sulphate)|"Microcrystalline cellulose
~Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach)"
15798226|NCT04465851|Other|Placebo (Curcumin)|"Microcrystalline cellulose
~Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach)"
15798227|NCT04465851|Dietary Supplement|Ferrous Sulphate 18mg|"Oral ferrous salt supplement
~Ferrous Sulphate 55 mg (equiv. 18 mg elemental iron content)
~Participants instructed to swallow opaque capsules with water away from meals (on an empty stomach)
~At the mid-point visit day (day 21) and the finally at the end-point (day 42) compliance will be verified by counting capsules"
15798228|NCT04465838|Other|NIS|This is a non-interventional study (NIS).
15798229|NCT04465825|Behavioral|HITT: intermittent high intensity exercise|Intermittent bouts of 30-60 seconds of exercise at 90% of peak intensity (HITT).
15798230|NCT04465812|Behavioral|Self-monitoring and personalized feedback on smartphone app|"Patients will record their blood pressure (once 1-week for patients with hypertension, every 3-month for those without), blood glucose (once 1-month for patients with diabetes), serum lipid metabolism (every 3-month for patients with dyslipidemia) on app, and medical staff will suggest continuing monitoring and recording or recommend outpatient visit;
~Patients will complete Pittsburgh sleep quality index test on app every 3-month, and medical staff will contact with patients with index > 15 to assess detail clinical status and recommend outpatient visit if necessary;
~Patients will complete Self-Rating Anxiety Scale (SAS) and Self-Rating Depression Scale (SDS) on app every 3-month, and medical staff will contact with patients with SAS>49 or SDS>52 to assess detail clinical status and recommend outpatient visit if necessary;
~Patients will complete cognitive training games every week on app;
~Medical staff will send health information on app"
15798231|NCT04465799|Behavioral|ENTREN|ENTREN intervention for children (cognitive-behavioral perspective + motivational interview)
15798232|NCT04465799|Behavioral|ENTREN-F|ENTREN intervention for children + family intervention.
15798233|NCT04465799|Behavioral|Control group|Behavioral modification of habits
15798234|NCT04465773|Procedure|general anesthesia for scheduled gynecological surgery|
15798235|NCT04465773|Drug|Propofol|continuous infusion, target concentration adjusted to maintain bispectral index between 45 and 55
15798236|NCT04465773|Drug|Remifentanil, Ultiva®|continuous infusion, target concentration 1 ng/ml
15798237|NCT04465773|Procedure|tetanic stimulations|10-20-30-40-50-60 milliamps, 5 seconds, 100 Hertz 2 minutes between stimulations delivered via the standard neuromuscular blocking agents monitor
15798238|NCT04465773|Device|VideoAlgesiGraph|non invasive infrared camera placed in front of the left eye of the patients during the study period, connected to a laptop. No part of the device touches the eye.
15798239|NCT04465760|Drug|Xisomab 3G3|Given IV or via catheter
15798240|NCT04465747|Other|Publications|Reviewing published evidence
15798241|NCT04465734|Drug|HLX10|HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.
15798242|NCT04465734|Drug|HLX04|HLX04 is an recombinant anti-VEGF humanized monoclonal antibody ，developed by Shanghai Henlius Biotech, Inc.
15798244|NCT04465721|Behavioral|TRE|The TRE intervention will be administered and monitored via the study app. It combines self-monitoring behavior, daily eating window reminders, positive reinforcement based on number of log entries or based on meeting eating widow target, and basic lifestyle text messages. It also allows research staff to monitor in real-time, via the backend cloud, adherence to self-monitoring, and to reducing the eating window.
15798245|NCT04465721|Behavioral|HABIT|The HABIT intervention will be administered and monitored via the study app. It combines self-monitoring behavior, positive reinforcement based on number of log entries, and basic lifestyle text messages. It also allows research staff to monitor in real-time, via the backend cloud, adherence to self-monitoring.
15798246|NCT04465708|Behavioral|Homework, Organization, and Planning Skills|HOPS is a 16-session, skills training program, provided individually to students in grades 6 through 8 who have OTMP skills deficits that contribute to academic difficulties. HOPS includes two parent consultations and one teacher consultation to promote generalization and maintenance of effects.
15798247|NCT04465695|Drug|Interferon beta-1b|Subcutaneous injection of interferon β-1b 1mL (0.5mg; 16 million IU) for 3 days
15798248|NCT04465695|Drug|Clofazimine|Oral 100mg twice daily on day 1, then 100mg daily for 2 days
15798249|NCT04465682|Device|Experimental: Dip Home-Based Dipstick Analyzer|Dip Home-Based Dipstick Analyzer The Dip Home-Based Dipstick Analyzer is a prescription, in-vitro diagnostic, home use device, which qualitatively and semi-quantitatively measures 10 urine analytes. The device combines a urine stick kit with an easy to use smartphone application using an image recognition algorithm.
15798250|NCT04465669|Device|Orsiro stents|"Percutaneous coronary intervention with implantation of either:
~a Orsiro® biolimus a9 eluting coronary stent"
15798251|NCT04465669|Device|Resolute Integrity® stents|"Percutaneous coronary intervention with implantation of either:
~a Resolute Integrity® zotarolimus eluting coronary stent"
15798252|NCT04465656|Diagnostic Test|Serology test for COVID-19|"In order to secondarily confirm the COVID-19 status of initially negative COVID-19 patients (by RT-PCR), a serology test will be performed in two parts:
~ELISA test
~Rapid Diagnostic tests (only if ELISA test is positive)"
15798253|NCT04465643|Drug|Nivolumab|Nivolumab 4.5 mg/kg Q3W x 2
15798254|NCT04465643|Drug|Ipilimumab|Ipilimumab 1 mg/kg Q3W x 2
15798255|NCT04465630|Device|OMNI® Surgical System|Ab-interno transluminal viscoelastic delivery and trabeculotomy performed with the OMNI Surgical System
15798256|NCT04465604|Other|Wearing surgical face mask sprayed with hypertonic saline|The inner surface of a standard surgical face mask will sprayed by 10 to 15 ml of HTS (6% w/v Saline solution prepared by adding 6 gram NaCl to 100 ml of water if not commercially available) and allowed to air dry. The participant will wear the face mask for 20-30 minutes every 6 hours until discharge, intubation for mechanical ventilation or death. A new HTS sprayed mask will be worn by the participant every 24 hours. The data items will be collected on daily basis
15798257|NCT04465591|Diagnostic Test|troponin T fragmentation test|laboratory test from blood sample
15798258|NCT04465578|Procedure|Sling tension adjustment by classic technique|We will adjust the tension of the sling by using the classic technique (2 fingers between the fascia and the knot)
15798259|NCT04465578|Procedure|Sling tension adjustment by height of 4 cm|We will adjust the tension of the sling by using the height between the fascia and the knot of 4cm
15798260|NCT04465565|Procedure|9% Sodium Chloride (NaCl) IV|9% Sodiun Chloride (NaCl) ( 20cc/kg) adminstrated intravenously
15798261|NCT04465552|Other|Patients received standard of care treatment during hospitalization|All patients admitted with covid-19 will be enrolled and followed for the duration of their hospitalization as well as during outpatient follow for up to 6 months, in those recovered, to assess clinical outcomes.
15798262|NCT04465539|Drug|Hydroxyethyl Starch 130-0.4 60 MG/ML [Voluven]|Hydroxyethyl starch dose is 500 cc in 6 hours
15798263|NCT04465539|Drug|Hydrocortisone|Hydrocortisone dose is 200-300 mg /day intravenously
15798264|NCT04465539|Drug|Placebo|received the standard ALP treatment according to TUPTC protocol as follows: patient resuscitation, care of airway, breathing and circulation, gastric decontamination with 2 ampoules sodium bicarbonate (each ampoule 25 ml containing 2.1 gm sodium bicarbonate) followed by activated charcoal in dose of 1 g/Kg orally, adequate hydration, normal saline administration (0.9% Sodium Chloride IV), vasopressors IV infusions, inhalation of 100% oxygen, ranitidine IV, magnesium sulfate IV infusion and other supportive treatment.
15798265|NCT04465526|Diagnostic Test|computed tomography perfusion imaging|The new-generation dual-source computed tomography scanner Somatom® Force will be used for all CTP studies. Myocardial perfusion will be evaluated in a stress dynamic CT protocol. The scan range will be determined based on a low-dose non-contrast scan. Subsequently, regadenoson will be administered intravenously at a single dose of 0.4 mg, and followed after 50 seconds delay by 35 mL of the iodinated contrast agent (iohexol, concentration 350 mg I/mL) injected at the flow rate of 5 mL/s. Finally, low-dose non-contrast dual-energy CT scan will be performed 5-6 min after the dynamic scan to assess late enhancement of the myocardium.
15798266|NCT04465513|Dietary Supplement|Best Standard of Care + CARDIO|Combination of dietary supplement with clinical care
15798267|NCT04465513|Dietary Supplement|Best Standard of Care|Combination of placebo with clinical care
15798268|NCT04465500|Radiation|External Beam Radiation|EBRT will be administered every 5 consecutive days for 5 consecutive weeks. This is standard of care practice for this therapy. This may be revised as applicable per treating physician discretion. The dose of radiation will be in accordance with standard clinical practice guidelines for the treatment of prostate cancer.
15798269|NCT04465500|Radiation|HDR Brachytherapy|HDR brachytherapy will be administered per standard clinical practice (per NCCN guidelines version 1.2020 for prostate cancer), however standard clinical practice may vary between clinicians. Therefore, the dose of 15Gy in 1 fraction and a set of dosimetry guidelines are to be followed for the purposes of this study. A diagnostic MRI will be co-registered with Transrectal Ultrasound (TRUS) to perform the HDR brachytherapy.
15798270|NCT04465500|Drug|Androgen Deprivation Therapy|The dosing and administration of ADT will be in accordance with the drug label for the drug(s) used for this purpose. Participants may receive ADT before and/or during the course of this study.
15798271|NCT04465487|Drug|REGN6569|Administered by intravenous (IV) infusion
15798272|NCT04465487|Drug|Cemiplimab|Administered by IV infusion
15798273|NCT04465474|Other|Non Intervention|It's an observational study, no intervention involves.
15798274|NCT04465461|Procedure|Video-assisted thoracoscopic surgery (VATS) fissure completion|Following Bronchoscopy and Chartis® balloon catheter assessment under general anaesthesia and confirmation of collateral ventilation, a unilateral VATS lobar fissure completion will be undertaken with buttressed staples and Coseal spray intended to eliminate collateral ventilation.
15798275|NCT04465461|Device|Zephyr Valve insertion|Following fissure completion surgery, subjects confirmed to be collateral ventilation negative will undergo bronchoscopic insertion of Zephyr® Valve(s) in the targeted lobe, under sedation or general anaesthesia.
15798276|NCT04465448|Other|MRI|Those included will perform an MRI without injection to obtain the QSM then they will exit the machine and reinstall themselves there to perform the second measurement. They will then change the MRI machine to perform a third measurement
15798277|NCT04465435|Other|Web-based self-report questionnaires|Web-based self-report questionnaires based on well established instruments.
15798278|NCT04465435|Other|Focus Group Interviews|Group conversation with open-ended questions with 7-10 students/group on topics relevant to the aim of the study.
15798279|NCT04465422|Behavioral|Occupational therapy based on the MOHO theory|"We selected two acute wards in the Songde hospital as the intervention group and the control group. At the same time, the demographic data of the participants were collected, including gender, age, age of onset, marital status, education level, work experience, etc., and the clinical records, including assessment of mental symptoms and medication records, etc. Continuity or categorical information on Occupational performance, personal and social performance, instrumental activities daily living, and clinical performance.
~OPHI-II, CGIS, PSP, LIADL, COPM, COTES were tested before and after in the intervention group and the control group to explain the intervention effect of the MOHO theory-based treatment model."
15798280|NCT04465422|Behavioral|Occupational therapy|The original Occupational therapy. OPHI-II, CGIS, PSP, LIADL, COPM, COTES were tested before and after in the intervention group and the control group to explain the intervention effect of the MOHO theory-based treatment model.
15798281|NCT04465409|Device|Intrastromal implantation of CorVision bioengineered corneal inlay for correction of presbyopia.|Presbyopia is an age-related progressive loss of crystalline lens accommodation power resulting in the decreased ability to see near objects. CorVision® is a tissue-mimetic device primarily intended to be used as a corneal inlay in the management of presbyopia and low hypermetropia. The inlay is inserted into the patient's cornea via a minimally invasive laser pocket procedure to modify corneal surface topography and corneal optical performance.
15798282|NCT04465396|Drug|Teduglutide|Participants will receive 3 mg or 4 mg of Teduglutide SC syringe injection followed by pen injector or vice versa depending upon the treatment sequence AB or BA on Day 1 of treatment period I and II.
15798283|NCT04465396|Device|Syringe|Teduglutide will be administered using syringe.
15798284|NCT04465396|Device|Pen injector|Teduglutide will be administered using pen injector.
15798285|NCT04465383|Device|Aqua© 30 Version 3.0 on Oncomfort SedakitTM|Digital Sedation session consists in a virtual reality software (Aqua© 30 Version 3.0, Oncomfort SA, Waver, Belgium) including a clinical hypnosis script.Patients in the intervention group will undergo a 30-minute Digital Sedation program through a VR headset and headphones. This medical device called Oncomfort SedakitTM has been created to reduce anxiety and pain during medical/ surgical interventions
15798286|NCT04465383|Drug|Propofol|Standard sedation starting doses of 1 µg/ml to 6 µg/ml depending on patient's reaction and titrated incrementally by 0.5µg/ml. Doses are adapted according to the level of comfort and needs of the patient.
15798287|NCT04465370|Device|Hemosphere Advanced Monitoring System, ClearSight 1.5, Swan-Ganz Catheter, Flotrac, Foresight|A Swan-Ganz catheter, FloTrac transducer, ClearSight finger cuff and ForeSight Elite sensors will be placed prior to the start of the catheterization procedure. Intermittent cardiac output and other hemodynamic parameters will be collected throughout the duration of the procedure and analyzed according to the Statistical Analysis Plan.
15798288|NCT04465357|Drug|Erenumab-Aooe 140 MG/ML [Aimovig]|140 mg/mL administered subcutaneously
15798289|NCT04465344|Device|Implantation of trifocal IOL, Isatis TF (device under investigation)|Patients will be implanted with study IOL in both eyes
15798290|NCT04465344|Device|Implantation of monofocal IOL, Isatis (control device)|Patients will be implanted with Control IOL in both eyes
15798291|NCT04465331|Other|Questionnaires|completion of Exercise Adherence Rating Scale (EARS)
15798292|NCT04465318|Other|E-cigarette (EC)|NJOY Daily E-cigarettes are self-contained and non-refillable. Each DAILY provides approximately 300 puffs, comparable to a full pack of cigarettes.
15798293|NCT04465318|Other|Nicotine Replacement Therapy (NRT)|Participants in the NRT arm will receive 21 mg nicotine patch (for those with CPD >= 20) or 14 mg nicotine patch (for those with CPD < 20) + 4 mg nicotine gum. CPD stands for Cigarettes Per Day.
15798294|NCT04465318|Behavioral|Smoking Harm Reduction Counseling Sessions|Counseling will cover health education, social support issues, and motivational enhancement to improve self-efficacy while addressing other aspects know to contribute to smoking among people with COPD (e.g., tips on dealing with depression)
15798295|NCT04465305|Procedure|entraped treatment|patients with tarlov cysts treated by entraped and plasty nerve root
15798296|NCT04465305|Procedure|plasty treatment|patients with tarlov cysts treated by plasty nerve root
15798297|NCT04465292|Drug|Tildrakizumab Prefilled Syringe|Patients will receive Tildrakizumab 100 mg subcutaneously at Weeks 0, 4, and 16. The study staff will administer each dose.
15798298|NCT04465279|Device|Trifocal diffractive intraocular lens|Trifocal IOL having foldable single-piece fully diffractive pupil dependent aspheric IOL. Which have been made of hydrophilic acrylic with an ultraviolet (UV) and blue light inhibitor. It has an optic diameter of 6.15 mm and an overall diameter of 10.75 mm; it has +3.5D additional power for near vision and +1.75 D additional power for intermediate vision, consisting of 26 diffractive steps.
15798299|NCT04465266|Drug|Tolperisone|tablets
15798300|NCT04465253|Other|Best Practice|Undergo standard of care occupational therapy
15798301|NCT04465253|Behavioral|Motivational Interviewing|Participate in discussions via videoconferencing
15798302|NCT04465253|Behavioral|Motivational Interviewing|Participate in interview via videoconferencing
15798303|NCT04465253|Other|Quality-of-Life Assessment|Ancillary studies
15798304|NCT04465253|Other|Questionnaire Administration|Ancillary studies
15798305|NCT04465240|Other|Virtual reality|Participants are immersed in a neighborhood environment in virtual reality
15798306|NCT04465201|Device|Impella CP with Smart Assist (Circulatory Support System)|Subjects will receive the Impella® with the Impella® Hemodynamics Platform prior to High risk percutaneous coronary intervention (HRPCI). Device escalation or early termination of the study will be allowed for subjects as deemed necessary by the treating physician. Subjects will be consented for follow-up through discharge from the index HRPCI admission.
15798307|NCT04465188|Procedure|Encircling scleral buckle surgical procedure|Encircling scleral buckle surgical procedure under general anesthesia
15798308|NCT04465175|Drug|Magnesium Sulfate|Second dose magnesium sulphate infusion over one hour
15798309|NCT04465175|Drug|Placebo|Normal saline (2.5 ml/kg) infusion over one hour
15798310|NCT04465162|Other|Radiation Therapy|Undergo radiation therapy
15798311|NCT04465149|Procedure|Third Molar Germectomy|Surgical extraction of Third Molars that exhibits at least a third of its root in formation, with a periodontal ligament discernible on panoramic x-ray (defined as germectomy).
15798312|NCT04465136|Device|CES, Alpha-Stim stimulator (Electromedical Products International, Inc., Mineral Wells, Texas, USA)|CES is a brain stimulation device with 2 electrodes on the bilateral earlobe. It uses Alternating current to stimulate the brain including thalamus, vagus nerve system and influence EEG and neurotransmitters like gamma-aminobutyrate. Stimulation was applied at a current intensity that can be adjusted continuously to provide between 10 and 600 micro-ampere and frequency of 0.5Hertz for 60 minutes, everyday for 6 weeks, total 42 sessions.
15798313|NCT04465123|Drug|Spironolactone or hydrochlorothiazide|"Patients will be received spironolactone or hydrochlorothiazide in combination with intravenous furosemide according to patients' serum potassium levels.
~If serum potassium levels ≤4 mEq/L, patients will be received spironolactone 100 mg every 12 hour for 72 hours.
~If serum potassium levels >4 mEq/L, patients will be received hydrochlorothiazide 50 mg every 12 hour for 72 hours."
15798314|NCT04465123|Drug|Placebo|"Patients will be received spironolactone placebo or hydrochlorothiazide placebo in combination with intravenous furosemide according to patients' serum potassium levels.
~If serum potassium levels ≤4 mEq/L, patients will be received spironolactone placebo every 12 hour for 72 hours.
~If serum potassium levels >4 mEq/L, patients will be received hydrochlorothiazide placebo every 12 hour for 72 hours."
15798315|NCT04465110|Dietary Supplement|Grape Seed Extract|Subjects took a single dose of 600 mg GSE in capsule form through ingestion 2 hours prior to testing Dietary Supplement: Grape seed extract Two capsule grape seed extract (total 600 mg) per day
15798316|NCT04465097|Drug|Tucidinostat|Tucidinostat: 30 mg BIW (Monday and Thursday) from week 3 to week 26
15798317|NCT04465097|Drug|Exemestane|Exemestane: 25 mg QD from week 1 to week 26.
15798318|NCT04465097|Drug|Ovarian function suppression|If the patient is premenopausal, leuprorelin 3.75mg or goserelin 3.6 mg will be injected every 28 days.
15798319|NCT04465084|Other|Case|Battery of standardised and normalised tests evaluating different cognitive functions Experimental language tasks MRI
15798320|NCT04465084|Other|Withness|Experimental language tasks MRI
15798321|NCT04465071|Drug|AEONTM Repair and AEONTM Protect Plus lubricating eye drops|AEONTM Repair and AEONTM Protect Plus lubricating eye drops
15798322|NCT04465058|Other|COVID19|viral infection
15798323|NCT04465045|Procedure|Laparoscopy-hysteroscopy|Under general anesthesia, we start by a first look in laparoscopy, to look for endometriosis mainly, tubal infertility, ovarian cysts or any abnormalities that may not have been suspected on the first exam. Then we check tubal patency after a look at the uterine cavity by hysteroscopy. Then we treat everything possible to treat to improve fertility, spontaneous or with ART.
15798324|NCT04465032|Other|Gut microbiome transplantation|Fecal transplantation will be performed at baseline and at week 3 and 6. At the Department of Clinical Bacteriology either the autologous or allogenic feces is prepared for donation by an experienced lab co-worker. The fecal transplantation will be performed via gastroduodenal endoscopy at the Department of Gastroenterology by an experienced endoscopist. To alleviate the procedure, midazolam is offered to the participants. Following placement of the endoscope in the horizontal duodenum, 150 mL feces solution is inserted via the endoscope.
15798325|NCT04465019|Device|Exoskeleton Rehabilitation|The EKSO GT® was operated by a Licensed Physical Therapist who was certified to control the device. We followed a strictly established protocol for operating the device during the rehabilitation process as established by the company.
15798326|NCT04465006|Other|Hippotherapy Simulator|Patients in the hippotherapy simulator group received 30 sessions of treatment for 6 weeks, 5 days a week and 1 hour a day. 45 minutes of Neurodevelopmental treatment exercises and 15 minutes of hippotherapy simulation exercise program were applied to the participants in this group.
15798327|NCT04465006|Other|Conventional Exercise|Patients in the conventionnal exercise group received 30 sessions of treatment for 6 weeks, 5 days a week and 1 hour a day. 60 minutes of Neurodevelopmental treatment exercises were applied to the participants in this group.
15798328|NCT04464993|Behavioral|Device-based feedback, self-monitoring, and education: CORE|"Participants will receive a core intervention which will include a basic version of the StandUPTV app on an android tablet and a Fitbit to use throughout the 16-week intervention.t. SST feedback will be provided within the smartphone application. Self-monitoring will provide passive and objective feedback regarding SST behaviors. StandUPTV will also contain basic education including information on the risks of SST and tips for reducing SST. As part of this education, all participants will be provided a behavioral target of reducing their SST by 50% from their baseline. This target will be customized for the participant within StandUPTV based on a baseline week of observation."
15798329|NCT04464993|Behavioral|Sedentary Screen Time lockout: LOCKOUT|Sedentary Screen Time lockout: LOCKOUT Sedentary Screen Time lockout: LOCKOUT The investigators will enforce a 50% per week reduction in SST, based upon a baseline week of observation. If SST reaches the prescribed threshold, the investigators will use the limits feature to restrict screen time through the end of the week (Monday-Sunday); at which point, 50% baseline allotment will be reinstated for an additional week. Participants will be prompted to plan for their screen time and provided modest allowances for exceeding their screen time in a given week.
15798330|NCT04464993|Behavioral|Context-based prompts: TEXT|The TEXT component uses app-based prompts (i.e., prompts generated through StandUPTV, not text message based) that will provide simple adaptive content. Content of the prompts will be educational (i.e., based on risks of sedentary screen time) and motivational (i.e., advice to reduce sedentary screen time).
15798368|NCT04464759|Drug|Hydroxychloroquine|Combination of nivolumab and hydroxychloroquine OR nivolumab, hydroxychloroquine and ipilimumab
15798331|NCT04464993|Behavioral|Earn sedentary screen time through moderate-vigorous physical activity: EARN|Earn sedentary screen time through moderate-vigorous physical activity: EARN Participants assigned to the EARN component will earn SST by engaging in a >5 min continuous bout of exercise (as defined by Fitbit minutes >4 metabolic equivalents). They will earn SST on a 3:1 ratio up until they reach their baseline level of MVPA (5 mins of exercise earns 15 mins of SST). They will receive behavioral strategies to reduce screen time within the app (e.g., self-efficacy, barriers, exercising safely) and a planning tool for scheduling MVPA.
15798332|NCT04464980|Drug|SL-BUP|Daily dosing of sublingual buprenorphine-naloxone
15798333|NCT04464980|Drug|XR-BUP|Weekly/monthly dosing of extended-release injectable buprenorphine
15798334|NCT04464980|Drug|XR-NTX|Monthly dosing of extended-release injectable naltrexone
15798335|NCT04464980|Behavioral|MM|MM consists of standard Medical Management and the usual counseling at the treatment program.
15798336|NCT04464980|Behavioral|MMR|MMR consists of Medical Management and usual counseling, plus Pear-002a, a technology-based behavioral component, to support retention and abstinence.
15798337|NCT04464980|Behavioral|MMD|MMD consists of Medical Management and usual counseling plus Connections, an app-based behavioral component to support discontinuation and recovery.
15798338|NCT04464967|Biological|SNK01|Patient-specific ex vivo expanded autologous natural killer cells
15798339|NCT04464967|Drug|Trastuzumab|HER2 receptor antagonistic, humanized immunoglobulin G subclass 1 (IgG1) monoclonal antibody
15798340|NCT04464967|Drug|Cetuximab|EGFR antagonist, chimeric immunoglobulin G subclass 1 (IgG1) monoclonal antibody
15798341|NCT04464954|Device|Auricular semi-permanent (ASP gold) needles|ASP semi-permanent Battlefield Acupuncture needles are semi-permanent needles that will remain in subject ears for 2-8 days and will be allowed to fall out on their own
15798342|NCT04464954|Device|Intradermal (long) needles using J-type No. 2 (.18)x 15mm|Intradermal (long) needles will remain in subject ears for 15-30 minutes and will be removed by a member of the study staff.
15798343|NCT04464954|Device|Pyonex needles (Seirin Yellow 0.2 x 0.6mm)|Pyonex needles will remain in subject ears for 2-21 days and allowed to fall out on their own.
15798344|NCT04464941|Behavioral|a composite intervention with both group and individual components for oral health promotion program|"The group intervention consisted of:
~1. Group oral health education 2. Display of Bass tooth-brushing methods 3. Broadcasting of songs as tooth-brushing reminders; The individual interventions included:
~1. Instruction in the Bass tooth-brushing method, 2. Individual behavioral modification method"
15798345|NCT04464928|Other|Facebook Advertisements|Counties will receive advertisements to VoicesForPFD.org's webpage on urinary incontinence on Facebook Ads when triggered by user characteristics indicating elevated risk of female urinary incontinence.
15798346|NCT04464928|Other|Google Advertisements|Counties will receive advertisements to VoicesForPFD.org's webpage on urinary incontinence on Google Ads when triggered by keywords relevant to female urinary incontinence.
15798347|NCT04464915|Other|Isopropyl alcohol swab|Treatment will be administered by taking one deep inhalation of an isopropyl alcohol swab held 1-2cm below the nares. Intervals of administration will be every 10 minutes or every 20 minutes for a total of one hour.
15798348|NCT04464902|Device|brace1|The brace1 can provide resistance when patients want to extend their knee.
15798349|NCT04464902|Device|brace2|The brace1 can't provide resistance when patients want to extend their knee.
15798350|NCT04464902|Other|No Intervention|Control Group don't have any brace.
15798351|NCT04464889|Drug|MDG1021 dose 1|3 patients to receive dose1: target dose of 0.3x10^6 HA-1H TCR transduced T cells/kg BW ±20% in 100 mL
15798352|NCT04464889|Drug|MDG1021 dose 2|3 patients to receive dose 2: target dose of 1x10^6 HA-1H TCR transduced T cells/kg BW ±20% in 100 mL
15798353|NCT04464889|Drug|MDG1021 dose 3|3 patients to receive dose 3: target dose of 3x10^6 HA-1H TCR transduced T cells/kg BW +20% in 100 mL
15798354|NCT04464889|Drug|MDG1021 optimal dose|20 patients to receive the selected optimal dose
15798355|NCT04464876|Device|SATURN TA System|SATURN TA TMVR Device implanted
15798356|NCT04464863|Other|Kinematic metrics|kinematic metrics recorded with Kinect (register brand) and extracted with Akira (register brand)
15798357|NCT04464850|Drug|Intravenous iron|"Iron sucrose will be given by continuous infusion for 1 hour during the last 1 hour of dialysis session. Iron sucrose will be given for 24 weeks during study period.
~Serum ferritin will be monitored at 4, 12, and 24 weeks after randomization.
~The dosage of intravenous iron will be adjusted according to serum ferritin levels as follows.
~Serum ferritin <500 mg/dl: iron sucrose 100 mg every 2 weeks Serum ferritin 500-800 mg/dl: iron sucrose 100 mg every 4 weeks Serum ferritin >800 mg/dl: discontinue iron sucrose"
15798358|NCT04464850|Drug|Oral iron|"1 tablet, three times a day, of iron fumarate will be prescribed for 24 weeks of study period.
~The dosage of iron fumarate will be adjusted according to serum ferritin levels as follows.
~Serum ferritin will be monitored at 4, 12, and 24 weeks after randomization.
~Serum ferritin <500 mg/dl: iron fumarate 200 mg three times daily Serum ferritin 500-800 mg/dl: iron fumarate 200 mg once daily Serum ferritin >800 mg/dl: discontinue iron fumarate"
15798359|NCT04464837|Device|Cold Snare Polypectomy of intermediate sized polyps (10-15 mm)|If an eligible polyp (10-15mm) is found, cold snare polypectomy is performed with the Olympus SnareMaster® Plus Snare
15798360|NCT04464824|Other|no intervention|no intervention
15798361|NCT04464811|Diagnostic Test|Furosemide stress test|Furosemide stress test is performed by administration of intravenous furosemide 1 mg/kg in patients who do not receive oral furosemide before and 1.5 mg/kg patients who have never received oral furosemide.
15798362|NCT04464798|Drug|CC-220|Oral
15798363|NCT04464798|Drug|Rituximab|SC and IV infusion
15798364|NCT04464798|Drug|Obinutuzumab|IV Infusion
15798365|NCT04464785|Device|CentriMag Circulatory Support System|The CentriMag Circulatory Suppose System is indicated for providing support for up to 30 days for one or both ventricles of the heart to treat post-cardiotomy patients who fail-to-wean from cardiopulmonary bypass, providing a bridge to decision when it is unclear whether the patient's heart will recover or whether the patient will need alternative, longer-term therapy.
15798366|NCT04464772|Device|FreeStyle Libre 3|FreeStyle Libre 3 Continuous Glucose Monitoring System
15798367|NCT04464759|Drug|Nivolumab|Combination of nivolumab and hydroxychloroquine OR nivolumab, hydroxychloroquine and ipilimumab
15798370|NCT04464746|Other|implementation of a specific program to improve therapeutic adherence|"Discussion of risks associated with high BP;aims,healthy lifestyle options.
~Individualized educational intervention:verbal, written,audiovisual information. Evaluation of knowledge of prescribed drugs.
~Behavioral counseling.training patients to participate in their own care, while positively modifying their skills or routines (i.e. pill boxes,calendars,specific measures to remind the patient taking drugs,adapt the regimen to atient's daily routine).
~Socio-psycho-affective interventions.
~Reminder systems: phone,email,alarm on the mobile phone.
~Simplification as far as possible of therapeutic scheme.
~Explanation of prescribed medications (name&dosage), correct intake.
~Explanation of possible side effects and what to do if they happen. Facilitate a contact.
~Advise and training on home blood pressure self-measurement.
~Verbal, written and/or audiovisual information and the online patients'section of scientific societies addresses will be provided."
15798371|NCT04464733|Drug|HRS9950|Group A to Group E: dose 1-dose 5, single dose Group F: dose 2, multiple doses Group C-: dose 3 food effect Group G to Group J: dose 2-dose4, multiple doses
15798372|NCT04464733|Drug|Placebo|Group A to Group J
15798373|NCT04464720|Behavioral|Cooking Ventilation Intervention|An educational video presentation for the families regarding the importance of ventilation use during and after cooking, and strategies for improving the ventilation during cooking, has been created by Dr. Holm, with input from Youth Research Assistants (YRAs) The youth involvement will help to ensure that the information is presented in a way that will resonate with the local community and will also provide the youth with exposure to developing health education tools. The educational video will be shown to families at the time of the intervention visit and they will receive printed reminder materials of what they have learned.
15798374|NCT04464707|Drug|Fremanezumab|Dose A or Dose B subcutaneous
15798375|NCT04464707|Drug|Placebo|Matching placebo
15798376|NCT04464694|Drug|Ranibizumab|Patients will receive single intravitreal injection of Ranibizumab 0.5 mg 3~7 days before vitrectomy.
15798377|NCT04464694|Other|Sham injection|Patients will receive single sham injection 3~7 days before vitrectomy.
15798378|NCT04464694|Procedure|Pars plana vitrectomy|Surgical procedure to remove the intravitreal hemorrhage and fibrosis membrane, and re-attach the retina, and perform endo laser photocoagulation on retina
15798379|NCT04464681|Drug|M201-A Injection|Active Substance: M201-A Route of administration: continuous intravenous injection
15798380|NCT04464681|Drug|Placebo|Placebo: M201-A Placebo Route of administration: continuous intravenous injection
15798381|NCT04464668|Behavioral|Provider Tools|Providers will be trained to use Electronic Medical Record (EMR) tools and prompts, and an organization wide cancer control champion will be trained to motivate providers and navigate patients.
15798382|NCT04464668|Behavioral|Provider surveys|Remote/electronic data collection surveys will be conducted with clinic institution leaders, cancer control champions, and providers from various clinic locations to solicit feedback about implementation processes at three time points (baseline, mid-point and end of study implementation)
15798383|NCT04464642|Drug|Methotrexate|Methotrexate 25 mg subcutaneous is given in group A
15798384|NCT04464642|Drug|Tofacitinib|tofacitinib 10 mg given in group B
15798385|NCT04464629|Drug|Dextenza|Intracanalicular sustained release dexamethasone insert 0.4 mg
15798386|NCT04464629|Drug|Prednisolone Acetate|Topical Prednisolone acetate 1% ophthalmic suspension
15798387|NCT04464616|Procedure|spinal anaesthesia|spinal anaesthesia will be performed with the patient in sitting position at the L3-L4 or L4-L5 interspaces with a 25 or 27 G spinal tip needle with the study drug in the total volume of 3 ml.
15798388|NCT04464603|Device|InterFACE (mHealth tool)|"Participants will be asked to perform consecutively two 20-min highly realistic, scripted CPR scenarios (first: PALS-based scenario, second: ATLS-based scenario) on a high-fidelity WiFi manikin.
~Within each scenario, 3 separate freeze periods will occur at random points in time to assess the shared and complementary Situation Awareness of each team member individually regarding the CPR in progress at that exact moment in time. The scenarios will be standardized to strictly follow the 2018 AHA algorithms and the 2018 ATLS guidelines.
~Both scenarios will be completed in the same order and the procedure will be standardized across all teams to follow the same chronological progression and range of difficulty in order to ensure that each participant is exposed to exactly the same case, with similar challenges in technical and non-technical skills.
~Participants allocated to Arm A will not be allowed to use any other cognitive support."
15798389|NCT04464603|Other|Conventional methods|"Participants will be asked to perform consecutively two 20-min scripted CPR scenarios (PALS and ATLS-based scenario) on a high-fidelity WiFi manikin.
~Within each scenario, 3 separate freeze periods will occur at random points in time to assess the shared and complementary Situation Awareness of each team member individually regarding the CPR in progress at that exact moment in time. The scenarios will be standardized to strictly follow the 2018 AHA algorithms and 2018 ATLS guidelines.
~Both scenarios will be completed in the same order and the procedure will be standardized across all teams to follow the same chronological progression and range of difficulty in order to ensure that each participant is exposed to exactly the same case, with similar challenges in technical and non-technical skills.
~Participants allocated to group B will be allowed to use the PALS pocket reference cards and a conventional calculator, but not any other cognitive support or mHealth tool."
15798390|NCT04464577|Drug|Fluconazole|Specified Dose on Specified Days
15798391|NCT04464577|Drug|Bupropion|Specified Dose on Specified Days
15798392|NCT04464577|Drug|Itraconazole|Specified Dose on Specified Days
15798393|NCT04464577|Drug|BMS-986235|Specified Dose on Specified Days
15798394|NCT04464564|Drug|AVP-786|oral capsules
15798395|NCT04464564|Drug|Placebo|oral capsules
15798396|NCT04464551|Drug|[14C]D-0316 suspension|Before administration, the drug preparation was placed at room temperature, and 40ml drinking water was added into each bottle to prepare suspension for the subjects to take. 40ml pure water was injected again. After washing the container, the subjects took orally. Repeat the previous step, and then used 160ml purified water. After the administration container was moistened for several times, the subjects took all the moistening lotion. Pay attention not to splash the liquid during mixing outside the bottle
15798397|NCT04464538|Behavioral|WALC-R|Initial group education session and individualized coaching (remote)
15798484|NCT04463693|Drug|Etonogestrel implant|Insertion of the contraceptive implant at an alternative insertion site located over the scapula
15798485|NCT04463680|Drug|Rifampin 600 MG|Administered daily for 2 weeks
15798398|NCT04464538|Other|Information leaflet|Participants in the control group will complete baseline measures, and then they will receive written information on the benefits of increasing activity levels. This advice will be given in accordance with NHS guide on physical health.
15798399|NCT04464525|Drug|Omecamtiv mecarbil|Film-coated tablet administered orally.
15798400|NCT04464512|Drug|Sufentanil|IV buprenorphine plus IV sufentanil treatment group.
15798401|NCT04464499|Diagnostic Test|ECG measurement|Simultaneous recording of a single-lead ECG signal with the Withings BPM Core and ECG signal for the reference 12-lead ECG
15798402|NCT04464486|Other|SCH Intervention|In addition to receiving usual care from their oncologist and staff, the SCH intervention group will report COVID-19 and cancer-related symptom presence and severity daily into the automated SCH system. Participants in the intervention receive automated self-management support messages for symptoms reported. In addition, COVID-19 symptoms and poorly controlled or worsening cancer symptoms will generate alerts. Based on preset thresholds, alerts automatically generate immediately from the patient's daily call data. The study nurse practitioners (NPs) monitor alerts. The NPs provide follow-up care using the guideline based SCH symptom clinical decision support system. The NPs log into the SCH Alert and Call Data website which displays all of the patients who have called that day and met an alert threshold. The NP calls the patient, delivers symptom management care by phone, and documents care in the patients' electronic health records.
15798403|NCT04464473|Device|transcranial magnetic stimulation|Transcranial magnetic stimulation delivered to the scalp targeting specific brain structures via stereotactic guidance.
15798404|NCT04464460|Drug|TAK-671|TAK-671 intravenous infusion.
15798405|NCT04464460|Drug|TAK-671 Placebo|TAK-671 placebo-matching intravenous infusion.
15798406|NCT04464447|Behavioral|Acceptance and Commitment Therapy|"The treatment ACT for Health in Adolescents (AHEAD) is an ACT-based Group intervention consisting of 9 modules (27 hours in total) delivered over a period of 3 months, with a follow-up meeting (3 hours) 3 months after the last module. Six to eight patients participate in each treatment Group. An information meeting (3 hours) for close relatives is held at the beginning of the Group treatment and the adolescents and their parents were invited to a 1½-hour individual consultation after the 8th module."
15798407|NCT04464434|Procedure|Upfront autologous HSCT|"HSCT comprises the following consecutive steps:
~Mobilisation
~Infusions of CYC 2g/m2 on 1 day.
~Hyperhydration, alkalinisation of urine and mesna to prevent haemorrhagic cystitis.
~Filgrastim (G-CSF) 5-10 μg/kg/day subcutaneously for 5 days (or more when necessary).
~Leukapheresis Prompt start of leukapheresis is required at a CD34+ cell count of ≥10-20/μL. Goal: at least 2 x 10^6 CD34+ cells per kilogram body weight.
~Conditioning
~CYC 50 mg/kg/day intravenously for 4 consecutive days (total 200 mg/kg)
~Rabbit Antithymocyte Globulin (rbATG), a total dose of 7.5 mg/kg i.v., from Genzyme.
~Hyperhydration, alkalinisation of the urine and mesna will be given to prevent haemorrhagic cystitis.
~I.v. methylprednisolone 2 mg/kg will be administered on the days ATG, to improve tolerability of the ATG.
~Peripheral stem cell infusion The number of CD34+ cells to be reinfused should be ≥ 2.0 x 10^6/kg."
15798408|NCT04464421|Behavioral|Contingency Management (CM)|Participants will be able to draw a gift card from a fishbowl when their urine toxicology results are positive for buprenorphine (i.e., they are adherent to Medication-Assisted Treatment). Gift cards in the bowl for drawing will be $25, $50, or $100.
15798409|NCT04464421|Behavioral|Brief Motivational Intervention + Substance Free Activities Session + Mindfulness-Based Adherence Promotion (BSM)|Participants will have one-on-one sessions with a behavioral interventionist to discuss their goals regarding treatment, how to reach these goals, and the importance of substance-free activities.
15798410|NCT04464408|Drug|Favipiravir|1800 mg twice daily for one day, followed by 800mg (4 tablets) twice daily
15798411|NCT04464408|Drug|Placebo|(9 tablets) by mouth twice daily for one day, followed by (4 tablets) twice daily (Maximum days of therapy is 7 days)
15798412|NCT04464395|Drug|CPI-006|Participants will receive a single dose of CPI-006 at one of four dose levels (0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg, or 5.0 mg/kg) along with standard of care.
15798413|NCT04464395|Other|Standard of Care|Participants will receive standard of care treatment only.
15798414|NCT04464382|Procedure|Outpatient (OA)|"Patients who are candidates for OA and therefore pre-selected based on the primary data and characteristics of the clinical signs, will be admitted to the surgical observation in charge of our service. The patient will be informed in detail of the intervention to be performed and discharge on an outpatient basis and will sign the informed consent understanding and thus accepting all the information. The patient will undergo surgery using a laparoscopic or open technique with minimal incision.
~Once the appendectomy is performed, all the selection criteria will be reassessed and the definitive inclusion of the patients will be performed. In this case, we will perform the blind randomization of the patients. If all the inclusion requirements for the study are met, and the patient belongs to the OA group (case group), he will be discharged on an outpatient basis from the post-surgical stay unit without requiring hospital admission."
15798415|NCT04464382|Procedure|Hospitalization appendectomy (HA)|"Patients who are candidates for HA and therefore pre-selected based on the primary data and characteristics of the clinical signs, will be admitted to the surgical observation in charge of our service. The patient will be informed in detail of the intervention to be performed and discharge on an outpatient basis and will sign the informed consent understanding and thus accepting all the information. The patient will undergo surgery using a laparoscopic or open technique with minimal incision.
~Once the appendectomy is performed, all the selection criteria will be reassessed and the definitive inclusion of the patients will be performed. In this case, we will perform the blind randomization of the patients. If all the inclusion requirements for the study are met, and the patient belongs to the case group (HA), he will be admitted in hospital beds."
15798416|NCT04464369|Drug|itopride|itopride is a gastroprokinetic drug that has previously been evaluated in the treatment of functional dyspepsia and which is available in a number of countries worldwide
15798417|NCT04464369|Drug|Placebo|placebo pills matching the look and weight of the itopride tablets
15798418|NCT04464356|Device|mechanical circulatory support|mechanical circulatory support: cardiopulmonary bypass, extracorporeal membrane oxygenation(ECMO), left ventricular assist device
15798419|NCT04464343|Other|no intervention|This is an observation study, with no intervention
15798420|NCT04464330|Other|no intervention|This is an observation study, with no intervention
15798423|NCT04464291|Other|Detection of Streptococcus pneumoniae strains|There will be detection of Streptococcus pneumoniae, serotype identification, susceptibility tests for penicillin, erythromycin, azithromycin, tetracycline, ciprofloxacin, levofloxacin, moxifloxacin and vancomycin
15798424|NCT04464265|Other|Functional Magnetic Resonance Imaging (fMRI)|"Propofol will be administered by intravenous infusion. All anesthesia equipment, supplies, and drugs will be provided by anesthesiologists from the University of Michigan Health System. The researchers will manually control the infusion of propofol to achieve target effect-site concentrations which will be maintained for 4 minutes each.
~Four types of music, including Jazz, Rock, Pop and Country, will be presented in a pseudo-randomized order. During the behavioral test period, participants will be asked to squeeze an Magnetic Resonance Imaging (MRI) compatible grip dynamometer (a rubber ball) for every 10-second periods (96 cycles in total). The beginning of each cycle will be cued with the spoken word squeeze."
15798425|NCT04464239|Drug|TS-142|TS-142 tablets
15798426|NCT04464239|Drug|TS-142 Placebo|TS-142 matching placebo tablets
15798428|NCT04464213|Other|Single dose experiments|In single dose experiments, after clean the diabetic foot ulcer, paint the Human placental mesenchymal stem cells gel on the wound, each patient only receive treatment once time.
15798429|NCT04464213|Other|Multi-dose experiments|In multi-dose experiments, after clean the diabetic foot ulcer, paint the Human placental mesenchymal stem cells gel on the wound, each patient receive treatment on six consecutive days.
15798430|NCT04464200|Drug|19(T2)28z1xx CAR T cells|2-7 days following the completion of the conditioning chemotherapy, patients will receive the CAR- T cells by IV infusion over 1-3 days depending on the dose level and formulation of the final CAR- T cells.
15798431|NCT04464174|Drug|Ipatasertib|Ipatasertib administered orally (400 mg) once a day, from day 1 to day 14, and rest from day 15 to day 21 of every 21-day cycle
15798432|NCT04464174|Drug|Capecitabine|Capecitabine administered orally (1000 mg/m2) twice a day, from day 1 to day 14, and rest from day 15 to day 21 of every 21-day cycle
15798433|NCT04464174|Drug|Eribulin|Eribulin 1.23 mg/m2 administered intravenously Days 1 and 8 of every 21-day cycle
15798434|NCT04464174|Drug|Carboplatin|Carboplatin AUC5 administered intravenously day 1 of every 21-day cycle
15798435|NCT04464174|Drug|Gemcitabine|Gemcitabine administered intravenously (1000 mg/m2) at days 1 and 8 of every 21-day cycle
15798436|NCT04464161|Dietary Supplement|Ensure|Ensure protein is a complete nutritional drink with 10g, 240 calories, and 27 vitamins and minerals. It is often used as a nutritional supplementation in many hospitals.
15798437|NCT04464148|Drug|Pregnenolone 250 mg|Pregnenolone 250 mg capsule BID (500 mg QD total)
15798438|NCT04464148|Drug|Pregnenolone 400 mg|Pregnenolone 400 mg capsule BID (800 mg QD total)
15798439|NCT04464135|Other|acetic acid staining|The water exchange colonoscopy is used during insertion procedure, in which the water contains 1% acetic acid, and the liquid is absorbed during the withdrawal process for observation.
15798440|NCT04464135|Other|Water exchange colonoscopy|The water exchange colonoscopy is used during insertion procedure, and the liquid is absorbed during the withdrawal process for observation.
15798441|NCT04464122|Drug|Somatostatin analog; chemotherapy|According to current ENETS guidelines, patients will be treated by somatostatin analogs or chemotherapy, recommended respectively as first line therapy in neuroendocrine tumours or neuroendocrine neoplasms.
15798442|NCT04464109|Procedure|Evisceration with orbital implantation|Evisceration will be performed. Alloplastic orbital implant will be inserted either posterior to the sclera or partly within the scleral canal.
15798443|NCT04464096|Other|non|non
15798444|NCT04464083|Diagnostic Test|IOP Measurment|To determine IOP readings before and after accelerated corneal collagen crosslinking (CXL)
15798445|NCT04464070|Dietary Supplement|niacin|induce biosynthesis of PGD2
15798446|NCT04464070|Drug|aspirin|inhibition of cyclooxygenase
15798447|NCT04464070|Other|PGD2|labeled precursor
15798448|NCT04464057|Dietary Supplement|early oral feeding or early enteral nurtrion|The patients in the experimental group were fed orally within 24-48 hours after intestinal anastomosis. Start taking it at 24-48 hours after surgery until discharged. The initial dose is 1ml/kg.h, which is gradually increased to 100ml/kg daily.
15798449|NCT04464044|Device|verofilcon A toric contact lenses|Daily disposable toric soft contact lenses
15798450|NCT04464031|Other|electronic alert|The e-alert system was developed by the divisions of Nephrology and Information Management of Guangdong Provincial People's Hospital (Patent Application 201610001950.5). The alert system made a diagnosis of acute kidney injury according to Kidney Disease: Improving Global Outcomes criteria. Then, the doctor receives an alert of acute kidney injury.
15798451|NCT04464018|Other|working grup|After each student received theoretical training, they performed an intravenous injection on the model. In the study group performed hybrid simulation. After finishing the simulation application. the students went to the analysis room and watched their own application videos. The analysis session was held immediately after all the students in the group completed their applications.The IM injection success Test and Student Satisfaction and self-confidence scale were applied to the study and control groups after the laboratory application was completed.
15798452|NCT04464005|Drug|Magnesium sulfate 33% solution|Topical pads with cold magnesium sulfate 33% solution will be given 5 times/day for 15 minutes
15798453|NCT04464005|Other|Cold water|Topical pads with cold water will be given 5 times/day for 15 minutes
15798454|NCT04463992|Behavioral|Program participants|The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk.
15798455|NCT04463992|Other|Usual Care|Usual care as provided by local oncologists
15798486|NCT04463667|Other|exercise|Collect all basic information including intrahepatic fat and fibrosis severity, and assign them to the exercise intervention group (n = 80) and the observation group (n = 20) after conditional screening.
15798456|NCT04463979|Other|Impact of Cerebellar Functional Topography on Cognition and Motor Ataxia|"Participants in this study will undergo surgical resection of their cerebellar or brain tumor (as per standard of care), as well as clinical and radiographic assessment, including: neurological physical examination (including Karnofsky Performance Scale (KPS) if conducted per Standard of Care), and magnetic resonance imaging (MRI) with or without diffusion tensor imaging (DTI)/tractography, prior to, immediately after, at one-month, 6-month, and 1-year follow-up status post-surgical resection. These data will also be collected at 18-month (±60 days) and 24-month (±60 days) visits post-surgery, if regular office visits with the neurosurgeon are scheduled at these two time points.
~Only at baseline, the following will be conducted: Brief Ataxia Rating Scale (BARS) assessment score, Cerebellar Cognitive Affective Scale (CCAS/Schmahmann syndrome) scale score, Montreal Cognitive Assessment (MoCA) assessment, and a quality of life (QoL) assessment using the SF-36 questionnaire."
15798457|NCT04463966|Drug|Tranexamic acid injection|1 gm (100 mg/ml) slowly intravenous infusion during delivery ( administered over 10 minutes at 1 ml/minute) .
15798458|NCT04463953|Drug|Zanubrutinib,Ixazomib and Dexamethasone|Zanubrutinib, 160mg orally, twice a day; Ixazomib, 4 mg orally, day 1, 8, 15; Dexamethasone, 20mg orally, days 1, 8, 15；Ixazomib and dexamethasone every 4 weeks of a cycle, with induction of 6 cycles, and then maintain every 12 weeks, up to 6 cycles (96 cycles in total). Zanubrutinib is taken orally twice a day for up to 96 cycles, with a reduction in the last ID cycle. ZID regimen will continue 6 cycles after reaching the maximum response after introduction section.
15798459|NCT04463940|Other|No intervention|No intervention
15798460|NCT04463927|Other|non-nutritive sucking|intervention group received a sterile gloved finger during the examination for retinopathy of prematurity
15798461|NCT04463914|Behavioral|Behavioral Activation Therapy app|Moodivate focuses on tracking daily activities, recording daily mood, and identifying new activities to complete that may help improve mood. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.
15798462|NCT04463914|Behavioral|Behavioral Activation Therapy app + EHR|Moodivate focuses on tracking daily activities, recording daily mood, and identifying new activities to complete that may help improve mood. The participant's primary care provider at MUSC will be provided access to a Moodivate provider portal that was developed by study team. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.
15798463|NCT04463914|Behavioral|Treatment as Usual|Participants will be provided educational material about mood management available via the EHR with the suggestion to discuss questions with their PCP. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.
15798464|NCT04463901|Procedure|Pterygium excision|Partial conjunctiva and anterior tenon's membrane underneath will be removed after the excision of pterygium tissue.
15798465|NCT04463901|Procedure|Intraoperative mitomycin C|Intraoperative mitomycin C (0.02%) will be applied for 5 minutes after pterygium excision.
15798466|NCT04463901|Procedure|Conjunctival autograft|A conjunctival autograft will be applied to cover the conjunctival defect after pterygium excision.
15798467|NCT04463901|Procedure|Limbal conjunctival autograft|A limbal conjunctival autograft will be applied to cover the conjunctival defect after pterygium excision.
15798468|NCT04463888|Other|occupational therapy|occupational therapy targeted to goals that are relevant to the functional needs of the patient
15798469|NCT04463875|Dietary Supplement|magnesium, vitamin B2, feverfew, andrographis paniculata and coenzyme Q10|Supplementation per os
15798470|NCT04463849|Diagnostic Test|Stimulation test with arginine infusion in order to verify the possible existence of damage to the beta cell function induced by COVID-19 infection|"All participants will be subjected to the collection of glycemic data through continuous professional retrospective monitoring of blood glucose for seven days, positioned on the day the test will be performed. During the entire recording period, parameters such as mean glucose, estimated glycosylated hemoglobin, peak glucose and nadir, blood sugar levels above the limit of 140 mg / dL, average glucose values at 60 and 120 minutes after meals, standard deviation and variability coefficient.
~The evaluation of insulin secretion will be evaluated by performing the stimulus test with arginine infusion according to validated protocols."
15798471|NCT04463797|Other|Square-stepping exercise|The square-stepping exercise is a low-cost indoor program to improve lower extremities fitness and cognitive function.
15798472|NCT04463797|Other|Stretching and strengthening|whole-body stretching and upper extremity strengthening
15798473|NCT04463784|Drug|Efavirenz 400Mg Oral Tablet|The experimental arm will receive 400mg efavirenz per randomization with other two antiretroviral medication (tenofovir and lamivudine).
15798474|NCT04463784|Drug|Efavirenz 600Mg Oral Tablet|The active comparator arm will receive 600mg efavirenz per randomization with other two antiretroviral medication (tenofovir and lamivudine).
15798475|NCT04463771|Drug|retifanlimab|INCMGA00012 administered intravenously on Day 1 of each 28-day cycle for up to 26 cycles.
15798476|NCT04463771|Drug|epacadostat|epacadostat will be administered orally BID.
15798477|NCT04463771|Drug|pemigatinib|pemigatinib will be administered orally QD.
15798478|NCT04463758|Other|An auto-questionnaire comprising three psychometric scales|"three psychometric scales validated in French: _depression (Edinburgh Postpartum Depression Scale (EPDS)), anxiety (State-Trait Anxiety Inventory (STAI)
~- and Impact of Event Scale (Revised) (IES-R)"
15798479|NCT04463732|Other|Loaded inspiratory muscle test and cardiopulmonary exercise test|This is an observational study. Loaded inspiratory muscle test is setting at 30% of maximal inspiratory pressure. Subjects will perform only 15 breaths under this intensity to exam the performance of their inspiratory muscles. Loaded inspiratory muscle test is not for training. Cardiopulmonary exercise test is performed by using bicycle ergometer. These two tests will be performed at least 1 week separately.
15798480|NCT04463719|Behavioral|Counseling using the electronic conversation aid|Patients receive counseling about thyroid biopsy with the use of the conversation aid.
15798481|NCT04463719|Behavioral|counseling by routine care|Patients receive counseling by routine care without the use of the conversation aid
15798482|NCT04463706|Other|Predictors adverse evolution|Predictors adverse evolution in all hospital participant admitted patients
15798483|NCT04463706|Other|Predictors of health care provide|Predictors of death, unequity, variability in process of care, cost in all COVID positive patients form the Basque Country
15798488|NCT04463641|Device|Implantation of the Axone 4LV Lead|Implantation of the Axone 4LV Lead
15798489|NCT04463628|Behavioral|Questionnaire|"The study questionnaire was constructed as follows:
~One part is composed of validated questionnaires: Cystic fibrosis specific self-questionnaire for quality of life, questionnaire for screening for anxiety disorder.
~The other part, which was not validated, was constructed as follows: questionnaire on knowledge of Covid-19 adapted to the new exceptional situation (Covid-19 pandemic) and specific questions adapted to the research objective on Covid-19 from the questionnaire of the French Public Health survey, to monitor changes in behaviour and mental health during lockdown"
15798490|NCT04463628|Behavioral|Interview|Two interviews in the human and social sciences, conducted by recorded video-conference, will be proposed to 15 patients during and after the lockdown.Two interviews will take place: one during the lockdown and one at 6 months from the first interview (or at the end of the confinement if it lasts more than 6 months). The interviews will be conducted independently of the results of the questionnaire.
15798491|NCT04463615|Drug|Leflunomide|Given PO
15798492|NCT04463602|Drug|Desidustat|100 mg once daily
15798493|NCT04463602|Other|Standard of Care|Standard of care as per local authority
15798494|NCT04463576|Other|Discharge Prescription|All hospital discharge prescriptions for patients aged 65 or over hospitalized or seen in consultation in the cardiology, internal medicine and neurology divisions of the Bordeaux and Rennes University Hospital and Georges Pompidou European Hospital will be recorded between June 1, 2018 and June 1, 2019.
15798495|NCT04463563|Other|Physiological|Changes to carbon dioxide, oxygen flow, cardiac output, blood pressure, haemoglobin, surgical surveillance, depth of anaesthesia, patient position.
15798496|NCT04463550|Other|Description and analysis|Retrospective, non-interventional study, using clinical, biological, radiological and therapeutic data collected during the initial diagnosis and follow-up.
15798497|NCT04463537|Procedure|Body Temperature Measurements|"measurements were carried out on the patients in the study firstly by not changing the position of the auricle. The duration was measured by stop watch and the results were recorded in the data form. The levels of patients' discomfort were evaluated by the Visual Comparison Scale.
~The measurement was then repeated after a minute, this time by changing the position of the auricle. The duration was measured for this position and the results were recorded in the data form."
15798498|NCT04463524|Device|Personal ECG digital sensor|Patients in test group will receive personal ECG sensor and in control gropu will not.
15798499|NCT04463511|Other|Polyethylene bag before the umbilical cord is clamped|"11 x 16 (279mm x 406mm) sterile resealable PB (Resealable Polybag, Helapet Ltd, Bedfordshire, UK)"
15798500|NCT04463498|Behavioral|Group-based cognitive behavioral therapy for insomnia|Sleep education, sleep restriction, stimulus control, cognitive restructuring, relaxation techniques
15798501|NCT04463498|Behavioral|Group-based cognitive behavioral therapy for insomnia and additive bb-glasses|Sleep education, sleep restriction, stimulus control, cognitive restructuring, relaxation techniques, bb-glasses worn from 3 hrs before bedtime.
15798502|NCT04463498|Other|8-week wait list for sleep-school|Treatment as usual in a psychiatric outpatient clinic
15798503|NCT04463485|Procedure|Delayed Clamping|Umbilical cord clamping was delayed 60 seconds at the end of second stage of labor.
15798504|NCT04463472|Biological|AG0301-COVID19|1.0 mg of AG0301-COVID19 twice at 2-week intervals
15798505|NCT04463472|Biological|AG0301-COVID19|2.0 mg of AG0301-COVID19 twice at 2-week intervals
15798506|NCT04463459|Drug|Vitamin C, Vitamin E|Vitamin C (500mg) twice daily and Vitamin E (400mg) once daily
15798507|NCT04463446|Behavioral|Use of the CHD app|Use of the CHD app
15798508|NCT04463446|Behavioral|Nurse-led intervention|Teaching session with clinic nurse
15798509|NCT04463433|Behavioral|Cognitive and behavioral intervention.|Two hours group sessions including mindfulness and emotion regulation. The practice of mindfulness is taught to parents to become aware of their thoughts and emotion on the present moment. The behavioral intervention has parents develop an Positive Time-out for dealing with conflict and negativity, using strategies to down-regulate their own negative emotions.
15798510|NCT04463433|Behavioral|Problem-solving and relationship improvement intervention.|Two hours group sessions including problem-solving and improving marital relationship . In the problem-solving part, the knowledge and techniques of problem-solving are taught to couple. relationship improvement part which promote the couple relationship by being aware of their own and their partner's deep-seated needs and communicating in a congruent way.
15798511|NCT04463420|Drug|PHR160 Spray|One puff spray per hour containing 300 mg of the drug will be given to patients. This treatment lasts up to 10 days.
15798512|NCT04463420|Drug|Placebo|participants will receive a placebo spray every hour. This process will continue for 10 days.
15798513|NCT04463420|Drug|Standard treatment|: Hydroxychloroquine 400 mg only on the first day / one naproxen 250 mg every 12 hours for 5 days / 500 mg azithromycin on the first day and 250 mg on the second to fifth days / 40 mg famotidine every 12 hours for 5 days / 25 mg prednisolone daily for 5 days
15798514|NCT04463407|Other|Educational talk about physical activity and nutritional recommendations before a critical period of fat gain in university students|An intervention was performed emulating a traditional nutritional session from a primary healthcare center (public health system). Traditionally, this session lasts around 20 minutes and includes a body composition measurement, nutritional assessment, and a brief educational talk about healthy eating. Just the intervention group received a series of healthy recommendations specially focused on the National Holiday.
15798515|NCT04463394|Drug|Vasopressin|Vasopressin administered intravenously
15798516|NCT04463381|Procedure|choledochotomy techniques during LCBDE|
15798517|NCT04463368|Procedure|Isolated hepatic perfusion|The procedure is performed under general anaesthesia. The caval vein is isolated infrahepatically above the renal veins and suprahepatically between the diaphragm and the pericardium. A catheter is placed in the retrohepatic portion of the caval vein for perfusion outflow. The portal vein is clamped and the proper hepatic artery is cannulated via the gastroduodenal artery. The liver perfusion is performed at a rate of 8- 9 ml/kg/min with a target liver temperature of 40 degrees Celsius. The leakage from the system was continuously recorded using Technetium labelled albumin (Vasculosis) injected into the perfusion circuit. Melphalan (1 mg/kg bodyweight divided into two doses, given 30 minutes apart) is added to the perfusion system. The perfusion is then continued for 60 minutes, after which the perfusion was discontinued.
15798518|NCT04463368|Drug|Ipilimumab|4 courses of ipilimumab 3mg/kg every third week
15798519|NCT04463368|Drug|Nivolumab|4 courses of nivolumab 1mg/kg every third week
15798520|NCT04463355|Behavioral|Video discharge instructions|Short video (2 minutes) including information about clinical features, management and follow up of pediatric patients with acute gastroenteritis
15798521|NCT04463342|Combination Product|Non Coated Glass Ionomer|KetacTM Universal AplicapTM Glass Ionomer Restorative saves time by eliminating the need for a coating-yet still delivers the compressive strength and surface hardness that are higher than several competitive glass ionomers which require one.
15798522|NCT04463342|Combination Product|Conventional Glass Ionomer with Coat|Conventional Glass Ionomer with Coat
15798523|NCT04463329|Procedure|conventional two-operator versus single operator using Jedi grip axillary brachial plexus blockage|on goup C, operator used the probe and needle with different hands while an assistant controlling the syringe to aspirate or inject local anesthetic. On Group J single operator controlled the probe with one hand while controlling the needle and the syringe on the other hand with the Jedi technique. The needle was held between the index finger and the middle phalanx of the middle finger, and the syringe was held with fingers 4 and 5, with the plunger part to the thumb in the palm.
15798524|NCT04463316|Diagnostic Test|Retrospective file studies|No intevention, retrospective file study: medical history, laboratory values, additional tests, physical and psychological complaints.
15798525|NCT04463303|Other|lung ultrasound|patient with or without weaning induced pulmonary adema
15798526|NCT04463290|Other|No intervention, Patients selection based on clinical symptoms and radiological imaging|No intervention
15798527|NCT04463277|Behavioral|Calorie Restriction|Participants assigned to this arm to consume food at a caloric deficit of 500 calories per day.
15798528|NCT04463277|Behavioral|Time Restricted Feeding|Participants assigned to this arm to consume food at maintenance calories (calories required per day to maintain weight, calculated based on height, weight and physical activity using the MyFitnessPal application) within an 8-hour window during daylight hours.
15798529|NCT04463277|Behavioral|Time Restricted Feeding with Calorie Restriction|Participants assigned to this arm to consume food at a caloric deficit of 500 calories per day within an 8-hour window during daylight hours.
15798530|NCT04463264|Drug|Nitazoxanide|NTX (500 mg every 6 hours for 14 days) orally with food (P.O.).
15798531|NCT04463264|Drug|Placebo|Placebo (1 tablet every 6 hours for 14 days) orally with food (P.O.).
15798532|NCT04463251|Biological|RPH-104 80 mg|solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL transparent glass vial
15798533|NCT04463251|Drug|Placebo|Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4-mL transparent glass vial
15798534|NCT04463238|Combination Product|Guided cartilage regeneration membrane|On the basis of microfracture, the blood clot released from the defect area is covered with a guide cartilage regeneration membrane to provide an attached scaffold for the cells in the blood clot.
15798535|NCT04463238|Procedure|Microfracture|Operate in accordance with the clinical microfracture surgery method.
15798536|NCT04463225|Other|Internet-Delivered Brief Intervention|The internet-delivered brief intervention developed for the study can be accessed via computers and mobile devices.. The intervention will employ assessment data to give study participants feedback on their drinking behavior and offer strategies to avoid risky behavior.
15798537|NCT04463199|Other|Craniocervical flexion training|"PBU airbag was clipped together and folded in, fastened, and placed suboccipital. Uninflated pressure sensor was kept below the neck, so that it touched the occiput then inflated to a stable baseline pressure of 20 mmHg to just fill the space below the neck but not to push it into lordosis. Subjects were demonstrated the correct action of the deep cervical flexors that is gentle nodding of head as if saying yes."
15798538|NCT04463186|Other|Muscle Static Stretching|Static stretching for 2 minutes (SS2), static stretching for 4 minutes (SS4), and static stretching for 8 minutes (SS8). Each static stretching (SS) trial involved varied repetitions of 30-seconds self-stretches and 20-seconds relax periods.
15798539|NCT04463173|Drug|Anaprazole|single dose, oral administration 30 minutes after breakfast with high fat food.
15798540|NCT04463173|Drug|Anaprazole|single dose, oral administration before breakfast.
15798541|NCT04463160|Other|"prevention program for prediabetes Say No to Diabetes"|10 therapeutic education sessions
15798542|NCT04463147|Device|Needle-pilotTM device|The main objective aims to compare the procedure time between conventional real time ultrasound guidance and guidance with Needle-pilotTM device.
15798543|NCT04463134|Drug|NTM drug treatment|NTM drug treatment according to guideline and sensitivity test results
15798544|NCT04463121|Device|Moderato IPG's CNT pacing signals|Assesment of cardiac function and sympatheric activity will be obtained simultaneously
15798545|NCT04463121|Device|CD Leycom Pressure/Volume Combination Catheters|Simultaneous recording of the Pressure, Volume measurements and ECG signals will be done for constant monitoring of intra-ventricular pressure and volume.
15798547|NCT04463095|Procedure|PER ORAL ENDOSCOPY MYOTOMY (POEM)|Peroral endoscopic myotomy (POEM)combines thelong-term efficacy of a myotomy with the benefits of an endoscopic, minimally invasive procedure.Other therapeutic options include endoscopic balloon dilatation and surgical myotomy. Endoscopic balloon dilatation is still widely performed because of its relative non-invasiveness and simplicity, but it has a relatively lower success rate and often requires multiple treatment sessions. Surgical myotomy has been thought to be the curative therapeutic choice for symptomatic achalasia. However, it requires skin incisions and additional anti-reflux surgical intervention.Unlike surgical myotomy, POEM preserves the anatomical integrity of the LES and possibly minimizes postoperative reflux.
15798548|NCT04463082|Procedure|Intravenous administration of fluids|Intravenous administration of fluids (20ml/kg, but the maximum volume will be limited up to 500ml) within 60 minutes.
15798578|NCT04462783|Other|Symptoms entered into the CovidX application|Participants are asked to enter symptoms into the CovidX application at least daily for 30 days. Additionally, they will enter demographic information and some survey information will be collected.
15798579|NCT04462770|Drug|EPX-100 (Clemizole HCl)|Daily dose of EPX100
15798580|NCT04462770|Drug|Placebo|Daily dose of Placebo
15798549|NCT04463069|Other|Adapted physical activity|This PA program was modified from an adapted physical activity (APA) program that designed for obesity management among adolescents with intellectual disability (ID). The aim of the APA program was to promote PA and health for people in special needs. In this study, the APA program was carefully designed based on a comprehensive pre-intervention assessment of each adolescent with ID, so that can be able to address their individual needs in learning and adaption. The APA program comprised three stages of APA training at school and each stage consisted of simple and fun endurance and strength-building exercise, at a frequency of two sessions per week, and lasting for about three months.
15798550|NCT04463056|Biological|Elizaria®|Induction cycle: 600 mg (2 vials of 30 mL, 10 mg/mL) intravenous infusion for 30 minutes once a week for 4 weeks. Maintenance therapy: 900 mg (3 vials of 30 mL, 10 mg/mL) intravenous infusion for 30 minutes in Week 5, followed by 900 mg every 14 days.
15798551|NCT04463056|Biological|Soliris®|Induction cycle: 600 mg (2 vials of 30 mL, 10 mg/mL) intravenous infusion for 30 minutes once a week for 4 weeks. Maintenance therapy: 900 mg (3 vials of 30 mL, 10 mg/mL) intravenous infusion for 30 minutes in Week 5, followed by 900 mg every 14 days.
15798552|NCT04463043|Device|SelfBACK app|The selfBACK is an evidence-based and data-driven decision support system (DSS) to support self-management of low back and neck pain delivered via a smartphone app. The selfBACK app provides individually tailored self-management plans to participants on a weekly basis by matching the participant's health information with targeted educational messages, physical activity advices and exercise recommendations via the DSS.
15798553|NCT04463043|Other|e-Help webpage|The e-Help is an evidence-based web-based resource to support self-management of low back and neck pain. The e-Help webpage provides evidence-based self-management content equivalent to the selfBACK including educational messages, physical activity and exercise recommendations. Instructions on how to compose exercise programs will be given to participants, however no tailored self-management support will be offered in this solution.
15798554|NCT04463043|Other|Usual care|Usual care refers to seeking care or receiving treatments or help as usual.
15798555|NCT04463030|Dietary Supplement|Liposomal vitamin C, 1 gram|after a blood draw 1 gram of vitamin c will be consumed followed by 3 additional blood draws
15798556|NCT04463030|Dietary Supplement|Liposomal vitamin C, 2 grams|after a blood draw 2 grams of vitamin c will be consumed followed by 3 additional blood draws
15798557|NCT04463030|Dietary Supplement|Liposomal vitamin C, 5 grams|after a blood draw 5 grams of vitamin c will be consumed followed by 3 additional blood draws
15798558|NCT04463030|Dietary Supplement|Placebo|after a blood draw placebo will be consumed followed by 3 additional blood draws
15798559|NCT04463017|Drug|HU6|HU6 is designed to reduce the steatosis, inflammation, fibrosis and hepatocyte injury in Noncirrhotic Nonalcoholic Steatohepatitis (NASH)
15798560|NCT04463004|Drug|Mavrilimumab|Treatment infusion
15798561|NCT04463004|Drug|Placebos|Placebo infusion
15798562|NCT04462991|Diagnostic Test|corneal topography|In all patients, TCT will be measured first by WaveLight® Oculyzer™II Pentacam HR and second by The Optovue AS-OCT .
15798563|NCT04462978|Other|Non IgE-mediated food allergy|Children with Non IgE-mediated food allergy
15798564|NCT04462965|Combination Product|Toripalimab|Injection,Specification 240mg/6ml, 3 mg/kg for the dose, iV, every 2 weeks a dose cycle, up to 1 year; Temozolomide: 100mg or 20mg, Every 4 weeks a dose cycle, up to 6 cycles Cisplatin: Injection, 20mg,Every 4 weeks a dose cycle, up to 6 cycles
15798565|NCT04462965|Combination Product|Temozolomide|Placebo：Injection,Specification 240mg/6ml, 3 mg/kg for the dose, iV, every 2 weeks a dose cycle, up to 1 year; Temozolomide: 100mg or 20mg, Every 4 weeks a dose cycle, up to 6 cycles Cisplatin: Injection, 20mg,Every 4 weeks a dose cycle, up to 6 cycles
15798566|NCT04462952|Drug|Adavosertib (AZD1775)|Adavosertib taken orally
15798567|NCT04462939|Dietary Supplement|Elevit Breastfeeding & Postnatal Care|Multi-micronutrients, lutein and DHA soft gel capsules; one capsule daily, oral
15798568|NCT04462939|Drug|Placebo|No active ingredients except of 225 μg iodine; One capsule daily, oral
15798569|NCT04462926|Diagnostic Test|[68Ga]Ga-PSMA-11 PET/CT|1.8-2.2 MBq (0.049-0.060 mCi) per kilogram bodyweight will be injected intravenously prior to perform the PET/CT
15798570|NCT04462913|Other|no intervention|This is an observation study, with no intervention
15798571|NCT04462887|Behavioral|Nursing intervention program|The intervention consisted of structured information (SI) provided in a booklet, nursing telephone support (NTS) and access to a nurse pager 24h/day. The SI booklet, Sudden Cardiac Arrest: A Survivor's Experience, contains 2 components: a descriptive component including individual verbatim statements about experiences of others during the first year of recovery and a management component outlining successful strategies used by others in dealing with issues in recovery. The NTS telephone calls included: check-in about current concerns, assessment of the topic for the week, review of common recovery experiences, discussion of behavioral strategies for dealing with the topic for the week, provision of positive feedback for strategies already working well, anxiety reduction statements, practice of new behaviors using role-playing and problem solving techniques, summarization, setting specific goals for the upcoming week, and collaborating on a learning assignment for the subsequent week.
15798572|NCT04462861|Device|Central venous access device (CVAD) Snuggie Securement Device|Participants will be given a prototype of a CVAD securement device for a three week trial. Descriptive data relating to user satisfaction will be collected at 1 and 3 weeks
15798573|NCT04462848|Biological|anti-SARS-CoV-2 human convalescent plasma|Single transfusion. The total volume (mL) to be transfused will be based on participant weight (kg) and will be calculated as 5 mL/kg. The maximum volume to be transfused will be 500 mL.
15798574|NCT04462822|Drug|Fluticasone propionate 250 mcg and salmeterol xinafoate 50 mcg/Respirent|2 inhalations of Test and Reference product in each study period
15798575|NCT04462822|Drug|ADVAIR DISKUS® 250/50|2 inhalations of Test and Reference product in each study period
15798576|NCT04462809|Drug|Talazoparib|"Talazoparib 1 mg a day (PO) (or 0.75 mg a day) for 2 years, started between 6 to 8 weeks after the end of chemotherapy discontinuation.
~Talazoparib will be given for up to 2 years, or less length of time in the case of disease progression,.
~unacceptable toxicity despite adequate management,patient decides to withdraw from the study, or general or specific changes in the patient's condition render the patient unacceptable for further treatment."
15798577|NCT04462796|Dietary Supplement|Magnesium Citrate|Magnesium Citrate 200 mg daily
15798581|NCT04462757|Drug|Anakinra 100Mg/0.67Ml Inj Syringe|100 mg interleukin-1 receptor antagonist (r-meth-Hu-IL-1Ra), anakinra; marketed as Kineret® in 0.67 mL prefilled syringe for single use
15798582|NCT04462744|Other|educational program|an oral health educational program regarding the emergency management of traumatic dental injuries.
15798583|NCT04462731|Procedure|Non-surgical root canal treatment filled with WVT|All eligible teeth were isolated with a rubber dam during root canal treatment. The procedures were performed under a microscope (OPMI Pico; Carl Zeiss, Gottingen, Germany). After access, location of canals, and determination of working length (WL) with Root ZX II apex locator (J Morita, Kyoto, Japan), the canals were instrumented using various .04 taper rotary NiTi instruments to a minimum apical size of 35. 4% Sodium hypochlorite was used as the main irrigant with a 31-gauge needle. 17% EDTA was used as the final irrigant. Passive ultrasonic irrigation with size 20 Acteon tip inserted 2mm short of WL was performed with both 4% sodium hypochlorite and 17% EDTA for 10 seconds in each canal. After final irrigation, the canals were dried with paper points. The master gutta-percha cone fit was verified with periapical radiographs before filling the tooth. WVT was used to fill the tooth when the months were January, March, May, July, September, and November.
15798584|NCT04462731|Procedure|Non-surgical root canal treatment filled with SBT|All eligible teeth were isolated with a rubber dam during root canal treatment. The procedures were performed under a microscope (OPMI Pico; Carl Zeiss, Gottingen, Germany). After access, location of canals, and determination of working length (WL) with Root ZX II apex locator (J Morita, Kyoto, Japan), the canals were instrumented using various .04 taper rotary NiTi instruments to a minimum apical size of 35. 4% Sodium hypochlorite was used as the main irrigant with a 31-gauge needle. 17% EDTA was used as the final irrigant. Passive ultrasonic irrigation with size 20 Acteon tip inserted 2mm short of WL was performed with both 4% sodium hypochlorite and 17% EDTA for 10 seconds in each canal. After final irrigation, the canals were dried with paper points. The master gutta-percha cone fit was verified with periapical radiographs before filling the tooth. SBT was used to fill the tooth when the months were February, April, June, August, October, and December.
15798585|NCT04462718|Other|Radiofrecuency|EXPERIMENTAL GROUP: After the initial evaluation, the first 10 treatment sessions will be developed at the rate of five daily sessions in the first week, three sessions on alternate days in the second week and two sessions on alternate days in the third week (3 weeks in total), applying the monopolar capacitive diathermy with radiofrequency in the anterior aspect of the knee, in dynamic application in one of the members: affect or randomized (uni or bilateral pathology, respectively). This diathermy will be combined with a therapeutic exercise program supervised by a Physiotherapist.
15798586|NCT04462718|Other|Therapeutic Exercise|CONTROL GROUP: will be provided exclusively therapeutic exercises protocol to develop in the home setting that you must perform following a daily activity for three weeks. They will be evaluated at the end of that period and six moths later in order to have at least three timepoints to evaluate.
15798587|NCT04462705|Procedure|Usual physiotherapeutic intervention and Abdominal Massage|Abdominal massage is not widely applied amongst general surgery team and is not part of the recommendation. This technique refers to profound manœuvrers of visceras through abdominal palpation and breathing, and has been used as part of the local protocol of Grenoble Alps University Hospital for many years with satisfactory results. No complications have been reported.
15798588|NCT04462679|Other|COMMIT mHealth application|We will develop Community-based mHealth Motivational Interviewing Tool (COMMIT) using iterative design and testing with frequent, structured input from the key stakeholders: community health workers (CHWs), their supervisors and youth living with HIV (YLWH).The tool will be used by community CHWs in Achham, Nepal to: 1) obtain decision-support to deliver motivational interviewing (MI) for patients in their communities, and 2) capture consented audio recordings of client interactions for review and feedback by their supervisors, allowing CHWs to maintain MI skills beyond the initial training period.
15798589|NCT04462666|Drug|Huzhang granule|Empty the content of one sachet into a mug, add 50ml warm water, stir until dissolved, add another 50ml hot water. Consume and complete all 100ml liquid mixture as a single dosage.
15798590|NCT04462666|Drug|Etoricoxib|take one capsule per day in the morning, at approximately 30 minutes after the meal.
15798591|NCT04462666|Drug|Huzhang granule Placebo|Empty the content of one sachet into a mug, add 50ml warm water, stir until dissolved, add another 50ml hot water. Consume and complete all 100ml liquid mixture as a single dosage.
15798592|NCT04462666|Drug|Etoricoxib Placebo|take one capsule per day in the morning, at approximately 30 minutes after the meal.
15798593|NCT04462653|Device|Wearable Dynamic ECG Recorder|use a Wearable Dynamic ECG Recorder to record heart rate and atrial fibrillation
15798594|NCT04462653|Device|12-lead ECG recordings|use a 12-lead ECG recordings to record heart rate and atrial fibrillation
15798595|NCT04462640|Other|Management of Infant Digestive Disorders and Quality of Life|The variation of the QUALIN score on D30 compared to inclusion (D0) will be described and compared using a Student test for paired data in the case of a normal distribution or a test of the ranks signed by Wilcoxon otherwise.
15798596|NCT04462627|Diagnostic Test|Blood group determination|Determination of the blood group (ABO/LE)
15798597|NCT04462627|Diagnostic Test|Antibody titration|Natural anti-A and anti-B antibody levels will be determined by a gel agglutination technique on the Biorad IH-500 automaton.
15798598|NCT04462627|Dietary Supplement|Probiotic|Administration of a probiotic to healthy volunteers to determine if it increases the level of circulating natural anti-A and anti-B antibodies (Probactiol Plus (Metagenics)).
15798599|NCT04462614|Drug|Decrease per-dialytic heparin therapy|Week 1: maintenance's dose stop Week 2: 50% drop in the loading dose Week 3: complete cessation of heparin therapy during the session.
15798600|NCT04462601|Other|Biomarker detection|Quantification of serum markers of intestinal permeability and bacterial and fungal translocation
15798601|NCT04462588|Drug|Cipro 400 MG in 200 ML Injection|medical tratment group
15798602|NCT04462588|Drug|Flagyl I.V. RTU|medical tratment group
15798603|NCT04462588|Procedure|appendectomy (open or laparascopic)|appendectomy (open or laparascopic)
15798604|NCT04462575|Procedure|Onlay bone block covered using collagen membrane|The ratio is 40% of xenogenic bone particles (low resorption rate) to 60% of autogenous bone particles (contains viable cells) to be placed in recipient decorticated site and covered by onlay bone block..
15798605|NCT04462575|Procedure|Onlay bone block without collagen membrane|Onlay bone block without collagen membrane
15799098|NCT04458532|Other|Aerobic Training|150 min/wk for 16 weeks
15798606|NCT04462562|Diagnostic Test|Quantitative US (Samsung Medison, RS85A)|In each patients, measurements of tissue attenuation imagine (TAI), tissue scatter-distribution imaging (TSI) parameters, hepatorenal index (EzHRI) will be performed
15798607|NCT04462549|Behavioral|Resource Facilitation|"RF involves working one on one with a brain injury specialist. This specialist is called a Resource Facilitator and works with clients to help set and achieve their own goals along with a team of professionals that specialize in this kind of injury. This may include brain injury education, family education, needs assessments, and service identification."
15798608|NCT04462536|Drug|Placebo|Vehicle only
15798609|NCT04462536|Drug|Nerinetide|Single intravenous infusion of nerinetide 2.6 mg/kg (up to a maximum dose of 270 mg) over 10 ± 1 minutes
15798610|NCT04462523|Drug|Dextenza 0.4Mg Ophthalmic Insert|The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration.
15798611|NCT04462523|Drug|Topical Prednisolone|Standard of care topical drop treatment
15798612|NCT04462510|Procedure|Block/Local infiltration|One group received ILI/IHG Block and the other group received local anesthetic infiltration for pain relief
15798614|NCT04462484|Behavioral|videoconference|The intervention is a person-directed, individual, primary occupational intervention. It will be carried out via videoconference in six sessions of 45 minutes (on a weekly basis). Through guided dialogue, individual difficulties and opportunities of each subject will be examined in order to gain self-awareness of personal characteristics (strengths, limitations, maximum workload capacity) in their particular set of job demands and resources. Participants are encouraged to adopt the set of self-care strategies in each dimension, adapting them to their specific context. Activities will be carried out in Spanish by the researcher.
15798615|NCT04462471|Diagnostic Test|I-124 PET/CT lesion dosimetry|I-124 PET/CT scans will be performed during this process to quantify baseline RAI avidity in index metastatic lesion(s)
15798616|NCT04462471|Drug|Vemurafenib|Dose level 1 & 2: 960 mg PO bid Dose level -1: 720 mg PO bid Dose level -2: 480 mg PO bid
15798617|NCT04462471|Drug|Copanlisib|Dose level 2: 60 mg IV weekly Dose level 1, -1, -2: 45 mg IV weekly
15798618|NCT04462458|Device|Medacta Anatomic Ribbon Surgery (M-ARS ACL)|M-ARS ACL allows to reconstruct the anterior cruciate ligament using the Anatomic Ribbon Technique
15798619|NCT04462445|Drug|Pazopanib|
15798620|NCT04462432|Other|no intervention|This is an observation study, with no intervention.
15798621|NCT04462419|Radiation|Dynamic Contrast-Enhanced Magnetic Resonance Imaging with Positron Emission Tomography|Undergo PET-MRI imaging
15798622|NCT04462419|Other|Fluciclovine F18|Given IV
15798623|NCT04462406|Biological|Ipilimumab|Given IV
15798624|NCT04462406|Biological|Nivolumab|Given IV
15798625|NCT04462406|Other|Patient Observation|Undergo active surveillance
15798626|NCT04462406|Biological|Pembrolizumab|Given IV
15798628|NCT04462354|Procedure|Blumgart Anastomosis|Patients undergoing cephalic duodenopancreatectomy, reconstructing pancreatic-enteric communication by Blumgart anastomosis
15798629|NCT04462354|Procedure|Pancreatogastric anastomosis.|Patients undergoing cephalic duodenopancreatectomy, reconstructing pancreatic-enteric communication by Pancreatogastric anastomosis.
15798630|NCT04462341|Device|Water Flosser|Device that uses water under pressure to clean around teeth and under the gums
15798631|NCT04462341|Device|Manual Toothbrush|Plastic handle with nylon bristles to clean teeth
15798632|NCT04462328|Drug|Durvalumab|Durvalumab will be administered over 60 minutes
15798633|NCT04462328|Drug|Acalabrutinib|Patients will take acalabrutinib orally every 12 hours (+/- 3 hours) daily.
15798634|NCT04462315|Drug|Everolimus Eluting Coronary Stent System|Everolimus Eluting Coronary Stent System (Everolimus Arm) implantation
15798635|NCT04462315|Device|Cobalt chromium balloon expandable stent (non-drug-eluting stent Arm)|Cobalt chromium balloon-expandable stent (non-drug-eluting stent Arm) implantation
15798636|NCT04462302|Behavioral|Internet-based pain coping skills program|The purpose of this study is to determine if an 8-session Internet-based pain management program can help you better manage your cancer-related pain.
15798637|NCT04462289|Behavioral|Proactive Outreach|Motivational electronic offer of tobacco cessation support with care connection to patient's choice of smoking cessation programs
15798638|NCT04462276|Drug|Atezolizumab|fixed dose of 1,200 mg as an IV infusion, on day 1, to be repeated every 3 weeks (Q3W)
15798639|NCT04462276|Radiation|thoracic radiotherapy (TRT)|30 Gy in 10 fractions
15798640|NCT04462263|Drug|HTL0014242|Solid suspension capsule
15798641|NCT04462250|Device|Prescription Opioid Management App|Smartphone application that provides education and reinforcement of safe opioid use, storage, and disposal
15798642|NCT04462237|Procedure|Root coverage procedures|Treatment of multiple adjacent gingival recession using a coronally advanced flap
15798643|NCT04462211|Procedure|Implementation of management pharmacological protocol of constipation|"first 48 hours:
~polyethylene glycol 3350 (about 17 grams) 1 every 8 hours enterally.
~Patients who have vomiting and / or gastric residue greater than 500 mL (in a timely measurement every 6 hours) will also be given domperidone 10 mg every 8 hours intravenously.
~Patients who have excessive abdominal distension will be administered in addition, levosulpiride 25 mg every 8 hours intravenously.
~48 hour evaluation:
~Patients who do not have bowel movements will be administered lactulose or sodium phosphate enema.
~For patients who do not have a bowel movement, administration of neostigmine intravenously or of naloxone enterally will be evaluated.
~Every patient who uses one or more prokinetics will have an electrocardiogram.
~Any patient who has bowel movements during management, doses of polyethylene glycol 3350 will be adjusted according to the daily goal of bowel movements, the days of treatment of the prokinetics will be adjusted, for a maximum of 5 consecutive days."
15798675|NCT04461925|Device|Оxygen therapy|Оxygen therapy, mechanical ventilation and other supportive therapies
15798879|NCT04460287|Dietary Supplement|DHA Dry Blending Method|Children will drink milk contain 100 mg DHA dry blending daily for 30 days
15798644|NCT04462211|Procedure|Implementation of bundle of prevention and non-pharmacological management|"Bundle of prevention:
~Start early enteral nutrition.
~Optimize and / or decrease opioid doses.
~Start early mobilization.
~Non-pharmacological management bundle
~Select laxative and/or prokinetic/s to manage constipation.
~Optimize and / or decrease doses of opioids and sedatives.
~Start early mobilization.
~Pharmacological reconciliation."
15798645|NCT04462198|Drug|PIPE-505|Intratympanic injection
15798646|NCT04462198|Drug|Diluent alone|Intratympanic injection
15798647|NCT04462185|Diagnostic Test|A genomic and transcriptomic landscape analysis|A genomic and transcriptomic landscape analysis will be developed to identify and characterize the transcriptome of benign versus malignant by using RNA sequencing, and to profile cfDNA in blood samples collected from patients with pulmonary nodules.
15798650|NCT04462159|Behavioral|Risk Reduction Program|Education, exercise, teaching kitchen and nutrition, and psychological support
15798653|NCT04462133|Diagnostic Test|Dual-priming oligonucleotide-based multiplex polymerase chain reaction (DPO-PCR)|Empirical H. pylori eradication treatment versus tailored therapy based on DPO-PCR results
15798654|NCT04462107|Other|Surveys|All participants will complete surveys that range in time from baseline to 3 months post partum.
15798655|NCT04462094|Drug|Ketamine 0.3 mg/kg at end-of-surgery|Ketamine 0.3 mg/kg at end-of-surgery (intravenously)
15798656|NCT04462094|Drug|Ketamine 0.3 mg/kg at anesthesia induction|Ketamine 0.3 mg/kg at anesthesia induction (intravenously)
15798657|NCT04462042|Radiation|Proton radiotherapy|Proton radiotherapy
15798658|NCT04462042|Radiation|Photon radiotherapy|Conventional photon radiotherapy
15798659|NCT04462029|Drug|BR4002|"Administration to the T1 group: 5 mg of BR4002 (patch) will be attached using an applicator for 24 hours
~Administration to the T2 group: 5 mg of BR4002 (patch) will be attached without using an applicator for 24 hours"
15798660|NCT04462029|Drug|BR4002-1|Administration to the R group: 5 mg of BR4002-1 (oral formulation) will be administered with 150 mL of water
15798661|NCT04462016|Other|Calamansi|250 ml of a commercially sourced calamansi drink
15798662|NCT04462016|Other|Glucose|75 g of glucose dissolved in 250 ml of drinking water
15798663|NCT04462003|Drug|Apixaban|10 mg/12 h for 1 week followed by 5 mg/12 h
15798664|NCT04462003|Drug|Enoxaparin|1mg/Kg/sc/12h
15798665|NCT04461990|Procedure|Multidisciplinary cooperative comprehensive treatment|Local surgery, radiation therapy, and systemic therapy such as chemotherapy, endocrine and molecular targeting.
15798666|NCT04461977|Other|True acupuncture|"The selection of acupuncture points is based on Traditional Chinese Medicine (Wen, 2011) and on previous studies (Jeong,2018; Bao,2018), selected as main points: bilateral baxie, SJ5, bafeng, KID3 and ST36. Modifications or additional secondary points may be indicated according to clinical judgment throughout treatment. The needles will be inserted at a depth of 10 - 15 mm, being gently manipulated to obtain de qi sensation. The needles will be left for 20 - 25 minutes. There will be once a week acupuncture treatment, for 8 consecutive weeks. The acupuncture needles will be sterile, disposable stainless steel needles size 0.20 x 30 mm, of Korean brand Dong Bang, Chungcheongnam-do."
15798667|NCT04461977|Other|Sham acupuncture|"Patients will receive needling at non-acupuncture points with superficial needling without manipulation to obtain de qi, located near the real points in the hands and feet. The needles will also be left for 20 - 25 minutes. There will be once a week acupuncture treatment, for 8 consecutive weeks. There will be once a week acupuncture treatment, for 8 consecutive weeks. The acupuncture needles will be sterile, disposable stainless steel needles size 0.20 x 30 mm, of Korean brand Dong Bang, Chungcheongnam-do."
15798668|NCT04461964|Device|Machine-vision Image Guided Surgery (MvIGS) spine navigation system.|"The intended use of the MvIGS navigation system is to provide high quality intraoperative imaging with no radiation exposure. Use of the proprietary integrated surgical light with embedded tracking technology and Flash™ registration allows for continuous and direct visualization of the surgical field. The MvIGS system is exempt from IDE regulations as the device cleared Premarket Notification FDA-510(k) (K162375). The device includes:
~A single mobile cart with a boom arm and an integrated surgical light with embedded tracking technology (P/N 10-0001);
~Proprietary imaging software (P/N 60-0007); and,
~Kit of tacked surgical instruments including a spine reference clamp, awl tip, pedicle probe (P/N 11-0006)."
15798669|NCT04461951|Other|Lifestyles (exposure)|no intervention
15798670|NCT04461938|Other|Fasting|The study intervention consists of one fasting cycle of 72 hours prior to biopsy/resection. Depending on clinical condition, patients can be hospitalized during the course of the study (e.g. need for medical assistance due to immobilization). Patients in good clinical condition will be admitted on day 3.
15798671|NCT04461925|Procedure|Placenta-Derived MMSCs; Cryopreserved Placenta-Derived Multipotent Mesenchymal Stromal Cells|i/v infusions
15798672|NCT04461925|Drug|Antibiotics|per os
15798673|NCT04461925|Drug|Hormones|a moderate amount of dexamethasone i/v
15798674|NCT04461925|Drug|Anticoagulant Therapy|Sub-Q
15798676|NCT04461912|Device|Eye Scan Ultrasound System (ESUS)|"• For the ultrasonic signals acquisitions, an ophthalmic probe working in A-mode scan, must be coupled to the cornea. To reduce the discomfort generated by coupling the probe, topical anaesthesia (oxybuprocaine hydrochloride) will be applied before starting acquisitions. However, if the participant has some known contraindication to this anaesthetic, in replacement, a disposable neutral contact lens will be used as coupling medium between the probe and the cornea.
~The acquisitions are initiated through a starting button in the system's user interface, and the probe must be kept by few seconds for automatic signals records. During this period, signals are visualized in the user interface. Finally the probe is uncoupled, and the acquired signals are saved."
15798677|NCT04461899|Biological|Blood test|additional blood test will be done 3 and 12 months after endometrioma sclerotherapy.
15798678|NCT04461886|Drug|NPC-12G gel|NPC-12G gel is containing 0.2% Sirolimus
15798679|NCT04461873|Other|Reiki|Reiki by touching
15798680|NCT04461873|Other|Sham Reiki|Sham reiki by gesturing and mimic imitation through touching
15798681|NCT04461847|Procedure|subcutaneous mastectomy|Operating subcutaneous mastectomy
15798682|NCT04461847|Procedure|endoscopic subcutaneous mastectomy|Operating endoscopic subcutaneous mastectomy
15798683|NCT04461821|Diagnostic Test|Real-time SESI-MS breath analysis|Participants will be asked to refrain from eating, drinking, chewing gum use or brushing their teeth at least 1 hour before the measurements will be performed. Room temperature and lighting will be set at the same level for all measurements. Participants will exhale through a disposable mouthpiece into a commercially available SESI source (FIT S.L., Spain). While performing full exhalations, the subjects will keep the pressure through the sampling line at a fixed value monitored by a digital manometer. Breath prints will be collected in real-time recording multiple replicates (typically six in positive and negative ion mode). The whole procedure is absolutely non-invasive and is usually accomplished without any effort in around 15 min per subject.
15798684|NCT04461821|Diagnostic Test|Off-line breath analysis|In young children below the age of 4 not capable of completing the on-line exhalation maneuvers, or in cases when the patient needs cannot approach the mass spectrometer, the sample will be collected off-line. They will be asked to exhale into a bag that will be transported to the lab and deflated into the mass spectrometer for analysis. Exhaled breath of patients under anesthesia will also collected using available ventilation system in the operation theatre.
15798685|NCT04461821|Diagnostic Test|Blood analysis|Blood analysis done in patients who undergo regular blood sampling needed for clinical routine laboratory controls. This includes i) children and adolescents receiving medications which require TDM ii) patients with acute diseases such as TD1 and pneumonia and iii) patients with chronic diseases such as asthma bronchiale. For those patients where a blood sample is drawn during the clinical routine, an additional blood sample consisting of only several blood drops will be collected using the same blood sampling line. No additional venous puncture for research purpose will be done.
15798686|NCT04461821|Diagnostic Test|Saliva analysis|During the diagnostic and therapeutic work-up of T1D patients, saliva samples are collected during the clinical routine. For those patients, additional samples will be obtained by clinically trained investigators.
15798687|NCT04461821|Diagnostic Test|Urine analysis|During the diagnostic and therapeutic work-up of T1D patients, urine samples are collected during the clinical routine. For those patients, additional samples will be obtained by clinically trained investigators.
15798688|NCT04461808|Diagnostic Test|tomosynthesis + synthetic 2D|"Women will be screened for one round with tomosynthesis + synthetic 2D, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings.
~After two years (one years for women 45-49 yo) women will be re-screened with digital mammography."
15798689|NCT04461808|Diagnostic Test|digital mammography|"Women will be screened for one round digital mammography, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings.
~After two years (one years for women 45-49 yo) women will be re-screened with digital mammography."
15798690|NCT04461795|Drug|Fremanezumab-Vfrm 225 MG/1.5 ML Subcutaneous Solution [AJOVY]|225 MG/1.5 ML Subcutaneous Solution
15798691|NCT04461782|Dietary Supplement|Lactobacillus plantarum|Oral food supplement
15798692|NCT04461769|Device|Transcranial Electrical Stimulation|Oscillating electrical current
15798693|NCT04461756|Drug|PPP001|inhalation (vape)
15798694|NCT04461743|Other|No intervention|No intervention, regular therapy
15798695|NCT04461730|Device|deep brain stimulation|Behavioral and electroencephalographic responses will be compared on and off deep brain stimulation
15798696|NCT04461717|Device|MicroNet covered stent implantation in the increased risk arterial lesions beyond the carotid bifurcation|Implantation of the MicroNet covered stent in the increased risk arterial lesions beyond the carotid bifurcation as per Vascular Team recommendation
15798697|NCT04461691|Procedure|Cryoballoon Pulmonary Vein Isolation|Cryoballoon pulmonary vein isolation is a common method for catheter ablation of atrial fibrillation. Cryoenergy is applied through a balloon in a single-step approach resulting in necrosis by tissue freezing.
15798698|NCT04461678|Diagnostic Test|HPV Genotyping Nucleic Acid Assay Kit|The total sample size of screening population is approximately 12,000 cases (all females ≥ 21 years of age). Two cervical cytology samples will be collected from each subject with a tube of SurePath sample followed by a tube of PreservCyt sample. The 1st tube of SurePath liquid-based cytology sample is used for cytology test and BD Onclarity Assay HPV detection. Subjects with cytology test results ≥ ASCUS or positive HPV test results will be suggested to return for baseline colposcopy within approximately 12 weeks.
15798699|NCT04461665|Other|vitamin D|vitamin D supplement 10 μg daily for 2 months
15798700|NCT04461652|Procedure|prophylactic air-extraction catheter drainage|This is a kind of venous catheter commonly used in clinic. It may bring less pain after being inserted into the chest, with an equivalent drainage effect with traditional thick drainage tube from our experience, especially in the aspect of gas drainage effect.
15798701|NCT04461639|Drug|Damoctocog alfa pegol (Jivi, BAY94-9027)|Different prophylaxis regimens with damoctocog alfa pegol following approved local labels or any other regimen prescribed by the physician as part of normal clinical practice
15798702|NCT04461626|Device|Persona fixed bearing knee system (All patients will receive Persona fixed bearing knee system)|
15798703|NCT04461613|Other|Original IPAQ followed by a revised one.|Comparing two questionnaires (a revised version and an original International Physical Activity Questionnaire short form) with an activity diary.
15798704|NCT04461613|Other|Revised IPAQ followed by an original one.|Comparing two questionnaires (a revised version and an original International Physical Activity Questionnaire short form) with an activity diary.
15798705|NCT04461600|Drug|AL101|AL101 is an inhibitor of gamma secretase-mediated Notch signaling.
15798706|NCT04461587|Drug|Pirfenidone|see previous entries
15798707|NCT04461574|Device|Orcellex Brush|Subjects will receive vaginal vault smear using both Orcellex Brush and Cervex Brush at the same follow-up visit, with order of smear taking decided by randomization.
15798708|NCT04461574|Device|Cervex Brush|Subjects will receive vaginal vault smear using both Orcellex Brush and Cervex Brush at the same follow-up visit, with order of smear taking decided by randomization.
15798709|NCT04461561|Genetic|end-of-life nursing education consortium-pediatric palliative care as web based-training plus usual care|The End-of-Life Nursing Education Consortium (ELNEC) project is a national education initiative to improve nursing education on end-of-life care. The project is administered by the American Association of Colleges of Nursing and City of Hope National Medical Center. The intervention group received training through the Relais Academy website
15798710|NCT04461548|Behavioral|Thinking, writing and imagining|All participants are asked to take some time to think and write about the content of the respective intervention group. After the writing exercise (approx. 15-20 min) participants are asked to imagine that content for about 5 minutes.
15798711|NCT04461535|Drug|Adrenocorticotropic hormone|Patients divided into Intervention group need to undergo stimulation with a continuous cosyntropin infusion (50 μg/h started 30 minutes before sampling during AVS). Right and left adrenal venous blood and corresponding peripheral venous blood should be sampled sequentially.
15798712|NCT04461522|Procedure|Ultrasound-guided drug injection|The injection drugs were glucocorticoids and anesthetic drugs (1ml+2% lidocaine hydrochloride 0.5ml+0.9% sodium chloride 0.5ml), and the injection sites were subacromion deltoid bursa/coracoid bursa/biceps longhead tenosynosheath/glenohumeral joint bursa, etc.
15798713|NCT04461509|Drug|18F-PSMA|"Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-PSMA)
~Other Names:
~18F-DCFPyL Injection prostate-cancer-specific radiotracer"
15798714|NCT04461496|Procedure|Hybrid revascularization|The first stage is performed femoral-popliteal bypass surgery above the fissure of the knee joint according to conventional technology. Conduit is at the discretion of the operating surgeon. Intraoperatively bolus is administered sol. heparin 5000 IU. The second step is the puncture of the selected CFA with a retrograde installation of the introducer sheath. The iliac segment is recanalized with angioplasty and stent implantation in the affected area
15798715|NCT04461496|Procedure|Full metall Jacket|The first step is the puncture contralateral CFA with a retrograde installation of the introducer. Intraoperatively bolus is administered sol. heparin 5000 IU. A conductor is placed in the contralateral iliac artery along the conductor. A stent is implanted in the iliac artery lesion. The second stage is the recanalization of the femoral-popliteal segment with angioplasty and stent implantation in the affected area.
15798716|NCT04461483|Drug|TAK-935|TAK-935 Tablets
15798717|NCT04461483|Drug|Placebo|TAK-935 placebo-matching tablets
15798718|NCT04461470|Genetic|epigenetic longitudinal waves|force - inducing energies using electromagnetic field(s)
15798719|NCT04461457|Combination Product|211-astatine MX35 F(ab')2|Alpha emitting radionuclide 211At conjugated to monoclonal antibody MX35 F(ab')2. Targeting the sodium phosphate transporter (NaPi2b).
15798720|NCT04461444|Genetic|Skin biopsy|"COBBALT is considered as an interventional with minor associated risks and constrains study due to the presence of skin biopsies that may not all be part of the usual medical practice. Risks are those linked to the biopsy procedure:
~risk of pain due to the procedure performed under local anaesthesia
~can leave a visible scar (about 2 x 1 cm)"
15798721|NCT04461431|Procedure|Arthroscopic anatomical reconstruction of the posterolateral structure of the knee|Arthroscopic anatomical reconstruction of the posterolateral structure of the knee for patients with injury of the posterolateral structure of the knee
15798722|NCT04461418|Drug|Glucocorticoid therapy|The study intervention is defined as treatment with either prednisone or dexamethasone as palliative therapy for the control of neurological symptoms; patients with symptomatic brain metastases with a requirement for glucocorticoid therapy will be treated with an available, standard-of-care immune checkpoint inhibitor regimen.
15798723|NCT04461405|Behavioral|INTEGRATE-D|INTEGRATE-D provides primary care practices with evidence-based training and support which includes: (1) Electronic health record (EHR)-based support-to help align EHR use with ADA recommendations and enable screening for depression, anxiety, DM distress, cognitive impairment, and self-management, and support identifying and tracking progress on patient treatments and goals; (2) Audit and feedback which involves assisting practices in accessing clinically relevant, actionable data reports to inform measurement and identification of care gaps in DMII and behavioral health care; (3) Skill-building resources including training on ADA-recommended care; and (4) Facilitation-to help implement the above strategies and the practice changes needed to align care with ADA recommendations.
15798724|NCT04461392|Diagnostic Test|Cardiorespiratory exercise test|"Cardiorespiratory exercise test to evaluate the exercise tolerance
~Cardiac imaging for the assessment of the left atrium anatomy and function."
15798725|NCT04461379|Biological|BCG vaccine|A single dose BCG vaccine intradermally (deltoid region of the right arm) 0.1 ml, equivalent to 0.075 mg of attenuated Mycobacterium bovis . (Tokio 172 strain)
15798726|NCT04461379|Other|Placebo|A single dose intradermally ((deltoid region of the right arm) 0.1 ml of NaCl 0.9% solution
15798727|NCT04461366|Device|Monopolar radiofrequency|The RF electrode was moved randomly for 30 seconds over each scar. The total duration of the treatment session is only 5 minutes for each cheek. It takes 15 minutes if the forehead and 2 cheeks are affected.
15798728|NCT04461366|Device|Pulsed dye laser|PDL was applied for the affected areas with no pre-treatment regimens or topical anaesthetics. There was no requirement for skin cooling.
15798729|NCT04461353|Drug|Aerolized Hydroxychloroquine Sulfate|sterile AHCQ 100 mg/mL for inhalation, is a clear solution packaged in clear glass vials and stored at room temperature.
15798730|NCT04461353|Other|Placebo|The placebo product and diluent solution is sodium chloride inhalation solution, United States Pharmacopeia (USP) 0.9%.
15798731|NCT04461340|Drug|Sirolimus|oral dose of 6 mg on day1 followed by 2 mg daily for 9 days
15798850|NCT04460456|Drug|Cemiplimab|350 mg IV
15798851|NCT04460443|Drug|sofosbuvir|Sofosbuvir once daily
15798732|NCT04461327|Behavioral|Painful stimulations of major depressive patients|"All three pain mechanisms will be tested in one session lasting 1h approximately.
~The mechanisms are tested in the following order:
~Aδ and C threshold
~Wind-up
~CPM
~(more details in detailed description)"
15798733|NCT04461327|Biological|Blood sample|The blood test is made between 2 and 24 hours before the experimental procedure. The biological collection is made to measure medications' concentration if the patient takes antiepileptics and/or lithium, and to measure complete blood count (CBC).
15798734|NCT04461327|Diagnostic Test|Clinical assessment|"A clinical assessment will be made by a trained researcher.
~(more details in detailed description)"
15798735|NCT04461327|Behavioral|Social touch|Stroking
15798736|NCT04461314|Behavioral|peer-led counselling|"About 50 university students will be trained as peer counsellors through a structured training programme. A pre and post and 6-month self-administered questionnaire will be conducted before, immediately and 6-month after the training programme to examine their changes of knowledge and attitudes. A satisfaction survey will also be conducted to measure participants' perception of the quality of the training programme.
~Drug-abusing youth and young adults will receive telephone-based, Peer-led Brief Motivational Interviewing (BMI) counselling to rehabilitate from drug abuse. The peer counsellors will give referral advice if the youth and young adult needs appropriate treatment and rehabilitation services.
~The drug abusers will be counselled and invited to complete the follow-up questionnaires at 1 week, 1 month, 3 months, 6 months, 9 months and 1 year. Self-reported quitters at 6-month and 1-year follow-ups will be invited to have a urine test to validate the drug abuse abstinence."
15798737|NCT04461301|Procedure|Multimodal Prehabilitation|A multimodal prehabilitation program (exercise, nutrition, anemia correction and smoking cessation).
15798738|NCT04461288|Behavioral|Social media-based education, counseling, and support|This six-month intervention is culturally-tailored to sexual and gender minority cigarette smokers. The intervention is group-based and includes daily posts and weekly live sessions during the initial three months. Posts and group sessions focus on tobacco use education, developing a quit plan, as well as managing stress, negative thinking, social support, exercise, as techniques to support cessation.
15798739|NCT04461288|Other|Nicotine replacement therapies (NRT)|"Participants will have access to up to six months of nicotine patch therapy. Participants will start on either 21, 14, or 7 mg patches based on manufacturers recommendations based on smoking behaviors.
~In addition to nicotine patch, participants will have access to a choice of 2 mg. nicotine lozenges or nicotine gum as an adjunct to patch treatment. Participants will be encouraged to use up to 5 pieces daily to address situational urges and cravings for a cigarette."
15798740|NCT04461288|Other|Gamification|Gaming elements designed to encourage participation in the program and behavior change.
15798741|NCT04461275|Other|ERAS 2.0|ERAS 2.0 accelerated protocol with adequate fluid management, pain control and truly minimally invasive surgery (intracorporeal anastomosis)
15798742|NCT04461262|Device|Camstent Coated Catheter|The patented 'M4D coating' is applied to inner and outer surfaces using a 'dip/dry' process before sterilisation, creating a safe, inert, and long-lasting finish. The coating reduces friction of the catheter surface, enhancing patient comfort on insertion and withdrawal. It also incorporates the materials which virtually preclude biofilm formation. The coating doesn't elute antibacterial agents or toxins, avoiding the build-up of dead bacteria on the device surface and retaining effectiveness throughout extended use (NB. Effectiveness is not lost because of leaching away of an active antimicrobial agent). Finally, the absence of anti-bacterial moieties means that the healthy microbial flora is not disturbed. The device is CE marked
15798743|NCT04461262|Device|Standard Care|Uncoated Foley catheter
15798744|NCT04461249|Drug|Latanoprost 0.005% Ophthalmic Solution|Latanoprost eye drops was given to newly diagnosed primary open-angle glaucoma patients once by night and intraocular pressure fluctuation was measured using Goldmann applanation tonometer.
15798745|NCT04461249|Drug|Travoprost 0.004% ophthalmic solution|Travoprost eye drops was given to newly diagnosed primary open-angle glaucoma patients once by night and intraocular pressure fluctuation was measured using Goldmann applanation tonometer.
15798746|NCT04461249|Drug|Tafluprost Ophthalmic 0.0015% Ophthalmic Solution|Tafluprost eye drops was given to newly diagnosed primary open-angle glaucoma patients once by night and intraocular pressure fluctuation was measured using Goldmann applanation tonometer.
15798747|NCT04461236|Dietary Supplement|Oral Supplement|Supplement provided in capsules. Half the capsules to be taken with lunch and the other half with dinner. All supplements are commercially available.
15798748|NCT04461236|Dietary Supplement|Placebo|Placebo
15798749|NCT04461223|Diagnostic Test|contrast-enhanced cardiac magnetic resonance imaging(MAGNETOM Aera 1.5T)|CMR T1 mapping, T2mapping, T2* mapping, LGE, ECV
15798750|NCT04461210|Diagnostic Test|Thermographic Imaging and Mechanical Pain Assessment|Assessment of pain sensitivity with mechanical stimulus (cotton swab) and thermographic imaging with infrared camera
15798751|NCT04461197|Device|customised foot orthoses|The foot orthoses for group A were custom made using phenolic foam molds of the feet. Separated molds were made of both feet for all the participants. . The insole was made based on a positive mold of plaster with 45 Shore cork materials with horizontal thrusts just proximal to the metatarsal heads, with the intention of correcting the pathological subtalar pronation, with a 3mm bilateral raising of the heel and a bilateral latex metatarsal bar.
15798752|NCT04461197|Device|orthotic insole|For group B, a flat insole of polyester resin was made, fitting it to the foot's size.
15798753|NCT04461184|Behavioral|Internet Wellness Intervention for Aging|Internet technologies have emerged as a platform for performing wellness interventions that also have wide outreach. Previous studies that have used the internet for delivering health interventions have found that older adults valued this platform, used it for researching health information and social communications. Likewise, the effectiveness of delivering health-related information intended for behavior change through the internet is equal to that of print-based delivery, thereby lowering costs and expanding reach. Thus, the internet provides a unique platform for conducting interventions. The internet based wellness intervention will be a low cost method focused on older adults to help increase intrinsic motivation through autonomy, competence, and relatedness (Intrinsic Motivation) to help increase daily physical activity.
15798754|NCT04461171|Procedure|Enhanced Recovery After Surgery|Undergo an enhanced recovery after surgery program
15798852|NCT04460443|Drug|Sofosbuvir ledipsavir|Sofosbuvir ledipsavir once daily
15798853|NCT04460443|Drug|Daclatasvir|Daklatasuvir tablets
15798755|NCT04461158|Behavioral|Patient Navigator Services|The navigator services most commonly provided include facilitation and coordination of care, practical support, including transportation and financial assistance, appointment scheduling and reminders, education and psychosocial support
15798756|NCT04461145|Behavioral|command|The participant was asked to walk along the walkway while backward counting numbers with increment of seven starting from a randomly given number.
15798757|NCT04461132|Other|Manual Lymphatic drainage (MLD)|MLD vith vodder technique was applied to leg
15798758|NCT04461132|Other|Skin Care|Wound was cleaned with salin and covered by dressing without including active products
15798759|NCT04461132|Other|Exercise|breathing and foot pump exercise was prescribed
15798760|NCT04461132|Other|Shame Manual Lymphatic drainage|manual lymphatic drainage was applied with light touch instead of real mld techniques
15798761|NCT04461119|Drug|Evenamide|oral capsules for 4 weeks of treatment
15798762|NCT04461119|Drug|Placebo|oral capsules for 4 weeks of treatment
15798763|NCT04461106|Other|Social Marketing Campaign|aims to raise awareness about the benefits of eggs - 'why eggs': increasing the value of eggs from a consumer perspective and encourage consumption of eggs by children (<5yrs) and pregnant/lactating women
15798764|NCT04461093|Other|Acupressure wristband and Palanosetron|"Group 1 Patients with odd numbers labelled form will be Group I patients. They will receive intravenous dexamethasone 8mg during induction. Acupressure P6 wristband is applied after induction and removed prior to emergence to maintain blinding. Intravenous ondansetron 4mg is given prior to skin closure.
~Group 11 Patients with even numbers labelled form will be Group II patients who will receive intravenous palonosetron 0.075mg during induction."
15798765|NCT04461080|Behavioral|Community Health Worker|Trained Community Health Worker
15798766|NCT04461067|Diagnostic Test|ultrasonography|Ultrasonography of the stomach is performed to measure the diameter of the antrum
15798767|NCT04461041|Drug|Empagliflozin|Single oral tablet
15798768|NCT04461041|Drug|Placebo|Placebo tablet manufactured to mimic empagliflozin 10 mg tablet
15798769|NCT04461028|Drug|Liposomal bupivacaine|20 ml mixture of 10 ml of Liposomal Bupivacaine 1.3% and 10 ml of Bupivacaine HCl 0.5%.
15798770|NCT04461028|Drug|Bupivacaine with Dexamethasone Solution|20 ml of Bupivacaine HCl 0.5% with 4 mg of preservative-free dexamethasone.
15798771|NCT04461015|Drug|0.4mU Insulin|Insulin infused at 0.4 mU/Kg/min
15798772|NCT04461015|Drug|0.8mU Insulin|Insulin infused at 0.8 mU/Kg/min
15798773|NCT04461002|Other|Retrospective analysis|Evaluate the correlation between tumour molecular profile and preoperative imaging data (FDG and FDOPA PET-scan and multimodal MRI).
15798774|NCT04460989|Procedure|arthroplasty|total knee replacement
15798775|NCT04460976|Behavioral|Psychoeducation for Adults With Autism and Their Significant Others/Family members (Prisma)|Psychoeducation in groups
15798776|NCT04460976|Behavioral|Treatment as usual/standard care|Standard care at disability/habilitation services.
15798777|NCT04460963|Other|Adrenomedullin|Adrenomedullin sample evaluation
15798780|NCT04460924|Drug|Integrase strand transfer inhibitors|Integrase strand transfer inhibitors as post-exposure prophylaxis or as antiretroviral treatment
15798781|NCT04460885|Drug|Insulin icodec|Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 78 weeks.
15798782|NCT04460885|Drug|Insulin glargine|Participants will receive subcutaneous (s.c.) injections of insulin glargine once daily for 78 weeks
15798783|NCT04460872|Drug|Testosterone Enanthate|Subjects receive testosterone (100 mg/week) by intramuscular injection
15798784|NCT04460872|Behavioral|Locomotor Training|Subjects receive locomotor training (4 sessions/week for 2-3 months)
15798785|NCT04460859|Other|Specific lung recruitment maneuvers|Specific lung recruitment maneuvers will be performed to measure the potential for lung recruitment at different levels of positive end-expiratory pressure (PEEP) provided by the mechanical ventilator. Electrical impedance tomography signals, synchronized signals of airway pressure and flow, esophageal pressure (if available), and volumetric capnography (if available) will be recorded continuously, during the time span of the protocol for offline analysis.
15798786|NCT04460846|Dietary Supplement|Alkaline water|1.5 liters per day
15798787|NCT04460846|Dietary Supplement|Reverse osmosis water|1.5 liters per day
15798788|NCT04460833|Device|Feedback modalities given through an augmented reality headset|All children wear the augmented reality headset. After a habituation period to the holograms, they start the protocol. It consists of a warm-up session, training session (which three feedback modalities are presented), calibration session (to get the maximal speed and spontaneous speed of the child), and test session. During test session, all the children walk on the 30m corridor. They have 6 feedback modalities + the control, given randomly. On the way out, they have to walk fast as possible ; on the return they have to walk at intermediate speed.
15798789|NCT04460820|Drug|Doxorubicin Hydrochloride Liposome Injection|50mg/m2,IV on Day 1 of each cycle
15798790|NCT04460807|Drug|Exemestane|Exemestane in addition to standard therapy, in Experimental arm.
15798791|NCT04460807|Other|Placebo oral tablet|Placebo in addition to standard therapy, in Control arm.
15798792|NCT04460794|Behavioral|Ballet-inspired workouts|8 weeks, delivered by volunteers with a self-directed resource package
15798793|NCT04460794|Other|Usual care|Usual care and general recommendations on basic stretching and leg exercises for stroke survivors
15798794|NCT04460781|Biological|Flublok Quadrivalent influenza vaccine RIV4|Route of administration: Intramuscular
15798795|NCT04460781|Biological|Standard-dose quadrivalent inactivated influenza vaccine SD-IIV4|Route of administration: Intramuscular
15798796|NCT04460755|Other|Control group|"A sample of cells from the buccal mucosa area will be taken with cytological sampling brush and will be fixed on on a microscopy slide and stained with a Feulgen fast green solution. The samples will be analyzed by electron microscopy. Tooth color will be measured, verified and evaluated with a Vita Easyshade V digital spectrophotometer in initial phase, after one month of usage, after two months of usage and one month after the end of usage.
~Before using any of the whitening toothpaste under test, every participant will use non whitening toothpaste for one month, twice a day.
~Satisfaction and impression with treatment will be recorded with the questionnaires provided for this study."
15798797|NCT04460755|Other|Whitening toothpaste 1|"A sample of cells from the buccal mucosa area will be taken with cytological sampling brush and will be fixed on on a microscopy slide and stained with a Feulgen fast green solution. The samples will be analyzed by electron microscopy. Tooth color will be measured, verified and evaluated with a Vita Easyshade V digital spectrophotometer in initial phase, after one month of usage, after two months of usage and one month after the end of usage.
~Before using any of the whitening toothpaste under test, every participant will use non whitening toothpaste for one month, twice a day.
~Satisfaction and impression with treatment will be recorded with the questionnaires provided for this study."
15798798|NCT04460755|Other|Whitening toothpaste 2|"A sample of cells from the buccal mucosa area will be taken with cytological sampling brush and will be fixed on on a microscopy slide and stained with a Feulgen fast green solution. The samples will be analyzed by electron microscopy. Tooth color will be measured, verified and evaluated with a Vita Easyshade V digital spectrophotometer in initial phase, after one month of usage, after two months of usage and one month after the end of usage.
~Before using any of the whitening toothpaste under test, every participant will use non whitening toothpaste for one month, twice a day.
~Satisfaction and impression with treatment will be recorded with the questionnaires provided for this study."
15798799|NCT04460755|Other|Whitening toothpaste 3|"A sample of cells from the buccal mucosa area will be taken with cytological sampling brush and will be fixed on on a microscopy slide and stained with a Feulgen fast green solution. The samples will be analyzed by electron microscopy. Tooth color will be measured, verified and evaluated with a Vita Easyshade V digital spectrophotometer in initial phase, after one month of usage, after two months of usage and one month after the end of usage.
~Before using any of the whitening toothpaste under test, every participant will use non whitening toothpaste for one month, twice a day.
~Satisfaction and impression with treatment will be recorded with the questionnaires provided for this study."
15798800|NCT04460755|Other|Whitening toothpaste 4|"A sample of cells from the buccal mucosa area will be taken with cytological sampling brush and will be fixed on on a microscopy slide and stained with a Feulgen fast green solution. The samples will be analyzed by electron microscopy. Tooth color will be measured, verified and evaluated with a Vita Easyshade V digital spectrophotometer in initial phase, after one month of usage, after two months of usage and one month after the end of usage.
~Before using any of the whitening toothpaste under test, every participant will use non whitening toothpaste for one month, twice a day.
~Satisfaction and impression with treatment will be recorded with the questionnaires provided for this study."
15798801|NCT04460755|Other|Whitening toothpaste 5|"A sample of cells from the buccal mucosa area will be taken with cytological sampling brush and will be fixed on on a microscopy slide and stained with a Feulgen fast green solution. The samples will be analyzed by electron microscopy. Tooth color will be measured, verified and evaluated with a Vita Easyshade V digital spectrophotometer in initial phase, after one month of usage, after two months of usage and one month after the end of usage.
~Before using any of the whitening toothpaste under test, every participant will use non whitening toothpaste for one month, twice a day.
~Satisfaction and impression with treatment will be recorded with the questionnaires provided for this study."
15798802|NCT04460742|Behavioral|CAPABLE Transitions|The CAPABLE Transitions intervention group will receive an occupational therapy-led multidisciplinary in-home intervention in which the study occupational therapist (<6 visits), registered nurse (<5 visits), and handyman (<2 visits) work with participants over 3-4 months. This intervention group also will receive home health agency care as usual services. CAPABLE Transitions in embedded within a home health agency and includes a care transitions emphasis.
15798803|NCT04460742|Behavioral|Home Health Agency Care|Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.
15798804|NCT04460729|Drug|Capmatinib|400 mg administered orally twice daily
15798805|NCT04460716|Procedure|Major noncardiac surgery|Vascular, thoracic, visceral, orthopedic, gynecologic, urologic, ENT, maxillo-facial, plastic and reconstructive surgery
15798806|NCT04460703|Other|Control message|2/15 of the sample will be assigned to the pure control group, which is a passage on the costs and benefits of bird feeding.
15798807|NCT04460703|Other|Baseline message|3/15 of the sample will be assigned to a control group with a message about the effectiveness and safety of vaccines.
15798808|NCT04460703|Other|Personal freedom message|1/15 of the sample will be assigned to this intervention, which is a message about how COVID-19 is limiting people's personal freedom and by working together to get enough people vaccinated society can preserve its personal freedom.
15798809|NCT04460703|Other|Economic freedom message|1/15 of the sample will be assigned to this intervention, which is a message about how COVID-19 is limiting peoples's economic freedom and by working together to get enough people vaccinated society can preserve its economic freedom.
15798810|NCT04460703|Other|Self-interest message|1/15 of the sample will be assigned to this intervention, which is a message that COVID-19 presents a real danger to one's health, even if one is young and healthy. Getting vaccinated against COVID-19 is the best way to prevent oneself from getting sick.
15798811|NCT04460703|Other|Community interest message|1/15 of the sample will be assigned to this intervention, which is a message about the dangers of COVID-19 to the health of loved ones. The more people who get vaccinated against COVID-19, the lower the risk that one's loved ones will get sick. Society must work together and all get vaccinated.
15798812|NCT04460703|Other|Economic benefit message|1/15 of the sample will be assigned to this group, which is a message about how COVID-19 is wreaking havoc on the economy and the only way to strengthen the economy is to work together to get enough people vaccinated.
15798813|NCT04460703|Other|Guilt message|1/15 of the sample will be assigned to this message. The message is about the danger that COVID-19 presents to the health of one's family and community. The best way to protect them is by getting vaccinated and society must work together to get enough people vaccinated. Then it asks the participant to imagine the guilt they will feel if they don't get vaccinated and spread the disease.
15798854|NCT04460430|Drug|Neratinib + endocrine therapy|Neratinib plus Fulvestrant, Exemestane or Tamoxifen
15798880|NCT04460287|Dietary Supplement|Fish Oil|Children will have this intervention every day for 30 days
15798881|NCT04460274|Other|Model Building|Model building
15798814|NCT04460703|Other|Embarrassment message|1/15 of the sample will be assigned to this message. The message is about the danger that COVID-19 presents to the health of one's family and community. The best way to protect them is by getting vaccinated and by working together to make sure that enough people get vaccinated. Then it asks the participant to imagine the embarrassment they will feel if they don't get vaccinated and spread the disease.
15798815|NCT04460703|Other|Anger message|1/15 of the sample will be assigned to this message. The message is about the danger that COVID-19 presents to the health of one's family and community. The best way to protect them is by getting vaccinated and by working together to make sure that enough people get vaccinated. Then it asks the participant to imagine the anger they will feel if they don't get vaccinated and spread the disease.
15798816|NCT04460703|Other|Trust in science message|1/15 of the sample will be assigned to this message about how getting vaccinated against COVID-19 is the most effective way of protecting one's community. Vaccination is backed by science. If one doesn't get vaccinated that means that one doesn't understand how infections are spread or who ignores science.
15798817|NCT04460703|Other|Not bravery message|1/15 of the sample will be assigned to this message which describes how firefighters, doctors, and front line medical workers are brave. Those who choose not to get vaccinated against COVID-19 are not brave.
15798818|NCT04460690|Device|Rapid Onsite COVID-19 Detection|saliva assay test for high concentrations of SARS-CoV-2
15798819|NCT04460677|Behavioral|Emotional Support Plan|The Emotional Support Plan (ESP) is designed to help adults to cope during periods of acute distress, such as those experienced during the COVID-19 pandemic.
15798820|NCT04460677|Behavioral|Daily Monitoring|The daily monitoring will remind participants 4x/day to report on their mood, distress, etc. and use their ESP if needed.
15798821|NCT04460664|Diagnostic Test|Quantra System|Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
15798822|NCT04460651|Drug|Icosapent ethyl (IPE)|"Participants in this arm will receive study medication IPE with the following dosage schedule:
~8 g of IPE (4 capsules every 12 hours - morning and evening, with food) for the first three days followed by 4 g of IPE (2 capsules every 12 hours - morning and evening, with food) thereafter (days 4-28 for treatment arm and 4-60 for prevention arm)"
15798823|NCT04460651|Drug|Placebo|Participants in this arm will receive placebo with the following dosage schedule: 8 g of placebo (4 capsules every 12 hours - morning and evening, with food) for the first three days followed by 4 g of placebo (2 capsules every 12 hours - morning and evening, with food) thereafter (days 4-28 for treatment arm and 4-60 for prevention arm)
15798824|NCT04460638|Biological|Saliva collection|Saliva samples are regularly collected over a period of up to 30 consecutive days.
15798825|NCT04460638|Other|Clinical assessment|The participant's clinical data will be collected regularly over a period of up to 30 consecutive days.
15798826|NCT04460612|Device|Active IR sock|Subjects will be wearing the infrared socks for 60 minutes
15798827|NCT04460612|Other|Placebo socks|Placebo Socks will be placed on participants feet first for 60 minute
15798828|NCT04460599|Other|Observation|Observation of recorded neurological signs
15798829|NCT04460586|Drug|Omadacycline Injection [Nuzyra]|Participants will receive single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of single dose omadacycline 300 mg PO.
15798830|NCT04460586|Drug|Omadacycline Oral Tablet [Nuzyra]|Participants will receive single dose of omadacycline 100mg IV followed by a 1-week washout and receipt of single dose omadacycline 300 mg PO.
15798832|NCT04460560|Drug|Terlipressin|"For the first dose of terlipressin, each vial will be reconstituted with 5 mL of sterile 0.9% sodium chloride solution and administered intravenously as a bolus injection and given over 1 minute at a dose of 0.5 mg.
~For continuous infusion, the dose of terlipressin is to be dissolved in 0.9% sodium chloride solution and infused with a pump"
15798833|NCT04460547|Drug|Convalescent Plasma Transfusion|Convalescent Plasma Transfusion to COVID-19 infected patients.
15798834|NCT04460547|Drug|Hydroxychloroquine|Hydroxychloroquine administration to COVID-19 infected patients.
15798835|NCT04460547|Drug|DAS181|DAS181 administration to COVID-19 infected patients.
15798836|NCT04460547|Drug|Ivermectin|Ivermectin administration to COVID-19 infected patients.
15798837|NCT04460547|Drug|Interferon Beta-1A|Interferon Beta-1A administration to COVID-19 infected patients.
15798838|NCT04460534|Diagnostic Test|diagnostic|The principle of this study is to propose to patients in whom a COVID-19 infection is suspected and who are screened for the disease, the joint search for the virus in the semen.
15798839|NCT04460521|Drug|N-Acetyl cysteine|In addition to splinting, both groups will receive an oral tablet to take daily for 8 weeks. Participants assigned to the experimental group will receive oral NAC (500 mg PO daily for eight weeks; based on recommended daily dose for use as an antioxidant and dosing in previous human clinical trials and animal studies), and those assigned to the control group will be given a similar looking placebo with identical instructions. Tablets will be provided in a blister pack to assist with compliance.
15798840|NCT04460521|Device|Wrist Splint|Participants in both arms will be given a standard prescription for a prefabricated night splint which keeps the wrist in a neutral position and instructed on proper use and the importance of consistent use. To limit splint variability, we will ensure that splint prescriptions are written such that a MedSpec Wrist Lacer II splint is obtained from the patient's pharmacy. This is the most commonly available brand locally and meets the criteria for wrist, metacarpophalangeal, and interphalangeal joint positioning. They will be advised to wear the splint consistently during sleeping hours on their affected wrist for eight weeks, as is the standard of practice.
15798841|NCT04460508|Drug|Pegylated rhG-CSF|Pegylated rhG-CSF:6mg
15798842|NCT04460508|Drug|rhG-CSF|rhG-CSF:5ug/kg/d
15798843|NCT04460495|Procedure|Arterial Spin Labeling Magnetic Resonance Imaging|Undergo ASL scan
15798844|NCT04460495|Procedure|pH-Weighted amine CEST|Undergo pH Weighted amine CEST
15798845|NCT04460495|Procedure|Oxygen-weighted SAGE-EPI|Undergo Oxygen-weighted SAGE-EPI
15798846|NCT04460482|Device|Near-infrared spectroscopy (NIRS)|NIRS-guided PCI
15798847|NCT04460482|Device|Angiography|Angiography guided PCI
15798848|NCT04460456|Drug|SBT6050|Escalating doses of SBT6050 in Part 1 and recommended dose in Part 2
15798849|NCT04460456|Drug|pembrolizumab|400 mg IV
15798855|NCT04460417|Behavioral|Enhanced Care|The session began with the therapist reviewing the participants' personal feedback sheet within the context of clear messaging that there is no safe level of smoking and of how smoking affects the participant individually and the Black community collectively. The participant was encouraged to quit smoking, else to reduce smoking if abstinence was not desired, and to use NRT within the next week to help foster behavior change and alleviate withdrawal symptoms. This portion of the counseling was presented within a culturally-targeted framework such that myths regarding NRT common among persons with low health literacy were discussed and debunked and historical mistrust of the medical community and concerns about exploitation were also addressed. Each participant in EC was offered a starter kit of NRT with a one week supply of patches or lozenges.
15798856|NCT04460417|Behavioral|TAU|"Participants met with a research assistant for 3-5 minutes and received the National Cancer Institute (NCI) pamphlet Clearing the Air and access to related online resources, which includes brief advice to quit smoking and medication information. They did not receive counseling or specialized care and were advised to refer to the resources should they be interested in quitting smoking."
15798857|NCT04460404|Behavioral|Lifestyle consultation|"Collect relevant data of patients included in the study through outpatient consultation, telephone follow-up, questionnaire follow-up, etc., including:
~Basic information
~Digestive tract symptoms:
~A constipation-related symptoms B abnormal symptoms
~Fecal traits
~Lifestyle habits
~Others"
15798858|NCT04460391|Behavioral|Intensive rehabilitation|Early standing training and routine rehabilitation
15798859|NCT04460378|Behavioral|cognitive behavioral therapy|cognitive behavioral therapy with Focus on guided exposure
15798860|NCT04460365|Dietary Supplement|10 mg Lutein, 2 mg zeaxanthin, 10 mg meso-zeaxanthin|"This is a lutein (10mg), zeaxanthin (2mg) and meso-zeaxanthin (10mg) one-a-day food supplement which combines all three macular carotenoids.
~These three nutrients are found at the back of the eye, at the macula, where they form the macular pigment (yellow colour). Meso-zeaxanthin is particularly concentrated at the centre of this pigment.
~Lutein and zeaxanthin can be found in fruits and dark green leafy vegetables and meso-zeaxanthin is present in some species of fish and seafood."
15798861|NCT04460365|Other|Placebo|Softgel capsule containing sunflower oil (no active ingredients)
15798862|NCT04460352|Radiation|Neoadjuvant radiotherapy (arm A)|1.8 Gy fractions 5 days per week in 23 fractions to a total dose of 41.4 Gy.
15798863|NCT04460352|Drug|Carboplatin, paclitaxel|Carboplatin AUC 2 + Paclitaxel 50mg/m2 weekly x 5 (day 1, 8, 15, 22, 29), starting same day as radiotherapy
15798864|NCT04460352|Procedure|Esophagectomy|Esophagectomy performed within 8 weeks after termination of chemoradiotherapy
15798865|NCT04460352|Radiation|Neoadjuvant radiotherapy (arm B)|"Two alternative schemes:
~1.8 Gy fractions five days per week in 28 fractions to a total dose of 50.4 Gy.
~2.0 Gy fractions five days per week in 25 fractions to a total dose of 50 Gy."
15798866|NCT04460352|Drug|Carboplatin, paclitaxel|Carboplatin AUC 2 + Paclitaxel 50mg/m2 on day 1 weekly during the full course of radiotherapy (5 weeks or 6 weeks, depending on the radiotherapy regimen used).
15798867|NCT04460352|Drug|Cisplatin, paclitaxel|Cisplatin 75mg/m2 on the first day of weeks 1 and 5 + 5-fluorouracil 1000 mg/m2/day by continuous infusion on the first four days of weeks 1 and 5.
15798868|NCT04460352|Drug|Oxaliplatin, calcium folinate, 5-fluorouracil|FOLFOX: Oxaliplatin 85 mg/m2, calcium folinate 200 mg/m2 and 5-fluorouracil 400 mg/m2 on the first days of weeks 1, 3 and 5 + 5-fluorouracil 800 mg/m2 by continuous infusion on the first two days of weeks 1, 3 and 5.
15798869|NCT04460352|Procedure|Esophagectomy|Esophagectomy only in case of residual or recurrent locoregional cancer.
15798870|NCT04460339|Other|Swimming participants in the 25-km|The 25-km race was the French national Open Championship event and participants were the swimmers registered for the race who volunteered to participate in this study
15798871|NCT04460326|Drug|Insulin glargine|Insulin glargine doses will be determined by calculating the total daily dose (TDD) of insulin and providing 50% of the TDD as follows: start at 0.5 units/kg/day and subtract 0.1 unit/kg/day for 70+ yrs of age, renal insufficiency, pancreatic deficiency and add 0.1 unit/kg/day if hemoglobin A1c in >10%
15798872|NCT04460326|Drug|NovoLog|Novolog will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
15798873|NCT04460326|Drug|Insulin Fiasp|Fiasp will be administered with each meal if premeal glucose is ≥ 150 mg/dL and at bedtime if glucose is ≥ 200 mg/dL by calculating an individualized insulin sensitivity factor for each subject per the following formula: 1500/total daily dose of insulin = sensitivity factor.
15798874|NCT04460326|Other|Standard carbohydrate diet|Standard carbohydrate diet as per usual hospital care (75g with each meal)
15798875|NCT04460313|Other|nasopharyngeal sample|nasopharyngeal swabs from children with acute otitis media aged 6 to 24 months. The swabs were analyzed by the French National Reference Centre for Pneumococci.
15798876|NCT04460300|Other|Aromatherapy-inhalation method|"In addition to the pharmacological treatment prescribed by the physician to individuals in this group, aromatherapy is carried out through the essential oil inhalation method. Individuals who can distinguish odors in the odor sense test before the application is included in the study. Aromatherapy inhalation is applied for three days and every other day (eg Monday-Wednesday-Friday) determined by the researchers for a week. Intervention is made between 07:00 and 08:00 in the morning hours when the blood cortisol value is maximized and homogeneity is provided.
~In this method, 5 drops of lavender oil will be dropped directly on a sterile gauze and individuals will be allowed to breathe from a distance of 10 cm for 5 minutes."
15798877|NCT04460300|Other|Aromatherapy-foot massage group|"In addition to the pharmacological treatment prescribed by the physician to individuals in this group, aromatherapy is applied through foot massage. Swedish massage protocol is followed in foot massage intervention.The foot massage is performed on three days and every other day (eg Monday-Wednesday-Friday) determined by the researchers for a week.The intervention is performed between 07:00 and 08:00 in the morning hours when the blood cortisol value is maximized and homogeneity is provided.
~Foot massage is done with 10 drops (5 drops per foot) of lavender for 10 minutes for each foot for 20 minutes. During the intervention, 20 techniques is used and the application time of each technique is 30 seconds (total 10 minutes per foot)."
15798878|NCT04460287|Dietary Supplement|DHA Wet Mixing method|Children will drink milk contain 100 mg DHA wet mixing daily for 30 days
15798882|NCT04460274|Other|Model validation|Model validation
15798883|NCT04460261|Other|Functional Inspiratory Muscle Training|Both groups were trained 3 days a week under the supervision of a physiotherapist and other days of the week without a supervisor. The treatment program consisted of 4 weeks of foundation IMT followed by 4 weeks of functional IMT. Foundation IMT was applied during the first 4 weeks of training. The participants were asked to sit in a comfortable upright position. Following the foundation IMT, all participants underwent four weeks of functional IMT. Initially, all participants were taught diaphragmatic breathing and activating abdominal wall musculature. Each training session started with warm-up exercises and ended with cool-down exercises. During the loading phase, core stability, dynamic trunk activation and postural control exercises were applied together with IMT.
15798884|NCT04460248|Drug|Zanubrutinib, Lenalidomide and Rituximab (ZR2)|"Induction therapy:
~The ZR2 regimen will be given from day 1 of each cycle of treatment. Each cycle will last for 21 days. Participants will receive a total of 6 cycles.
~Dosage:
~Zanubrutinib, 160 mg bid, po, day 1-21;
~Lenalidomide, 25 mg qd, po, day 2-11;
~Rituximab, 375 mg/m2, ivgtt, day 1.
~Maintenance therapy:
~Patients who receive complete response or partial response after induction therapy will receive lenalidomide 25 mg qd po during 1-10 days in every 21 days, for a maximum of 2 years."
15798885|NCT04460222|Procedure|Rotational Thromboelastometry to guide blood product transfusion pre invasive procedure|"Rotational Thromboelastometry will be performed pre procedure and blood component will be transfused if
~EXTEM CT more than 80 sec then FFP will be transfused at 15 ml/kg MCF less than 35 mm then Platelet will be transfused at 10 ml/kg
~FIBTEM MCF less than 7 mm then Cryoprecipitate will be transfused at 5 ml/kg"
15798886|NCT04460222|Procedure|Conventional transfusion methods to guide blood product transfusion pre invasive procedure|Transfusion will be given If INR: 1.5 - 2.5 FFP will be transfused at 10 ml/kg If Platelet Count is 20,000/mm3-50,000/mm3 Platelet will be transfused at 10 ml/kg If Fibrinogen < 80 mg/dl Cryoprecipitate will be transfused at 5 ml/kg
15798887|NCT04460209|Other|Standard of Care|Standard of care mapping and/or ablation
15798888|NCT04460196|Other|survey|Each admitted patient will complete a questionnaire
15798889|NCT04460183|Drug|RESP301, a Nitric Oxide generating solution|Product application requires inhalation using a standard handheld nebulizer.
15798890|NCT04460183|Other|Standard of Care|Participants will receive institutional SOC for the treatment of COVID-19.
15798891|NCT04460144|Diagnostic Test|Mass spectrometry|Proteomic analysis
15798892|NCT04460131|Diagnostic Test|soluble ST2|Serum sST2 was measured on a monoclonal electrochemiluminescence immunoassay. Samples were exposed to two freeze cycles before analysed. Samples were exposed to two thawfreeze cycles before analysed.
15798893|NCT04460118|Procedure|Bristow surgery fixed by the screw|Bristow surgery fixed by the screw
15798894|NCT04460118|Procedure|Bristow surgery fixed by the suture button|Bristow surgery fixed by the suture button
15798895|NCT04460105|Drug|Lanadelumab|Participants will receive 300 mg of lanadelumab IV infusion on Day 1 and Day 4.
15798896|NCT04460105|Other|Placebo|Participants will receive placebo matching IV infusion on Day 1 and Day 4.
15798897|NCT04460092|Device|5-mm 32-gauge Insulin needles in the first three days of Intervention|32-gauge needles with a length of 5mm to inject insulin in first three days
15798898|NCT04460092|Device|8-mm 32-gauge Insulin needles in the first three days of Intervention|32-gauge needles with a length of 8mm to inject insulin in first three days
15798899|NCT04460092|Device|5-mm 32-gauge Insulin needles in the last three days of Intervention|32-gauge needles with a length of 5mm to inject insulin in second three days
15798900|NCT04460092|Device|8-mm 32-gauge Insulin needles in the last three days of Intervention|32-gauge needles with a length of 8mm to inject insulin in second three days
15798901|NCT04460079|Drug|Peg-filgrastim|PegaGen® was injected as a single subcutaneous dose after completion of cytotoxic chemotherapy
15798902|NCT04460066|Drug|anti-PD-L1 antibody|Patients will receive 16 cycles of anti-PD-L1 antibody 5mg/kg IV on day 1 every 3 weeks.
15798903|NCT04460066|Drug|albumin bound paclitaxel|Patients will receive 6 cycles of albumin bound paclitaxel 125mg/m2 on days 1, 8 every 3 weeks .
15798904|NCT04460066|Drug|cisplatin|Patients will receive 6 cycles of cisplatin 75mg/m2 on day 1 every 3 weeks.
15798905|NCT04460066|Drug|placebo|Patients will receive 6 cycles of placebo IV on day 1 every 3 weeks.
15798906|NCT04460066|Procedure|radical resection of esophageal carcinoma|Patients will receive radical resection of esophageal carcinoma after 4 cycles of chemotherapy.
15798907|NCT04460053|Procedure|Neurofilament light protein measurement in Isolated limb perfused patients|A prospective feasibility trial measuring neurofilament light protein in peripheral blood as a biomarker for neurotoxicity after isolated limb perfusion.
15798908|NCT04460040|Behavioral|Exercise training|"The first phase of the study will comprise two weeks of control phase when participants will not engage in any exercise training but will be monitored for total daily energy expenditure and its components (REE, SMR, and DIT) and assessed volume of metabolic organs and skeletal muscle efficiency.
~Next, participants will start the active phase. In the first two weeks, participants will perform 150 - 200 min/week of a moderate intensity exercise so that they can adapt to the new regime and avoid injury. All exercise training will be monitored using heart rate sensor (HR) to track exercise adherence and HR range goals. Changes in daily non-exercise physical activity and sedentary behavior will be assessed for 10 days pre- and post-intervention by a tri-axial accelerometer. All study participants will be instructed to consume their habitual diet and to maintain the same caloric intake."
15798909|NCT04460027|Other|Woebot Substance Use Disorder|Woebot Substance Use Disorder is an automated conversational agent, available through a smartphone application, that delivers evidence-based psychotherapeutics, empathy, and emotional health psychoeducation.
15798910|NCT04460014|Behavioral|Simple cognitive task intervention|"Session 1: A memory cue followed by playing the computer game Tetris (e.g. on own smartphone) with mental rotation instructions.
~Options to engage in self-administered/guided booster sessions per intrusive memory."
15798911|NCT04460014|Behavioral|Attention Placebo|Session 1: Digital activity for same amount of time (e.g. listening to podcast on own smartphone).
15798912|NCT04460001|Drug|Ranibizumab|Intravitreal
15798913|NCT04460001|Drug|Ranibizumab|Intravitreal
15798914|NCT04460001|Drug|triamcinolone acetate|intravitreal
15798915|NCT04459988|Drug|Ocrelizumab|Description Needed
15798944|NCT04459728|Behavioral|Wellness Element 4 - Social Connectedness|Daily wellness element focusing on social connectedness; adherence documented online daily
15798916|NCT04459975|Other|Non interventional study|"Comorbidities, creatinine levels, urinary analysis, hemodynamic, respiratory status, co-medication will be collected from medical files for each patient.
~Specific datas from patients with AKI will be collected from medical files For severe acute patients, serum and urinary analysis will performed to identify the underlying cause of kidney injury For severe AKI patients who will die, post-mortem renal biopsy will be performed, for histopathological analysis"
15798917|NCT04459962|Diagnostic Test|Breath Test & Cheek Swab|Breath Sample and Cheek Swab of participants will be used for machine learning (NBT - Nanobiotechnology Biomarkers Tagging) system to develop a profile which can be used later on for Covid-19 Diagnosis.
15798918|NCT04459949|Device|Sharkskin|Use of Sharkskin ILM forceps
15798919|NCT04459949|Device|Grieshaber|Use of Grieshaber ILM forceps
15798920|NCT04459936|Other|URICORI|Treatment for cardiovascular risk factors according to national guideline administered at the department of Rheumatology
15798921|NCT04459936|Other|CONTROL|Treatment for cardiovascular risk factors according to national guideline administered at the General Practitioner
15798922|NCT04459923|Procedure|ultrasound-guided erector spinae plane block catheter|for postoperative pain management ultrasound-guided erector spine plane block catheter placement
15798923|NCT04459923|Procedure|thoracic epidural catheter|for postoperative pain management thoracic epidural catheter placement
15798924|NCT04459910|Procedure|Arthroscopic Brostrom combined with Arthroscopic Deltoid Repair|After anesthesia and surgical site preparation, traditional arthroscopic portals were performed. A 4.5mm set was used to clean the joint and assess possible associated injuries. Anterolateral and anteromedial impacts were resected when needed. Lateral and medial instability were confirmed arthroscopically, and ligament repairs prepared, starting by the lateral compartment. A traditional Arthroscopic Brostrom was performed, using one anchor and suture passers. Sutures are passed but not tightened. Medial anchor insertion is executed at the medial malleolus, in the quadrant described by Vega et al. Sutures were passed respecting the safe zone illustrated by Acevedo at al. The ankle was positioned in neutral (no posterior drawer) and the lateral sutures tightened with arthroscopic knots. Finally, the medial repair is finalized by tightening the deltoid sutures with the ankle at the same position. Portals were closed and a dressing applied.
15798925|NCT04459897|Other|Evaluation of epithelioid and gigantocellular granulomas within the hepatic parenchyma by histopathology approach.|: Retrospective histopathology review done by an expert of histopathology analysis (DAPI cell labeling). Analysis of the percentage of epithelioid cells and the percentage of gigantocellular granulomas in hepatic parenchyma of patient diagnosed for Hepatitis Granulomatous
15798926|NCT04459884|Procedure|mechanical ventilation|mechanical ventilation > 48h
15798927|NCT04459871|Biological|recombinant human Thrombin(CHO cell)|2 rhThrombin, dissolved in 5mL sterile saline and mixed, the final solution contains 1000IU/mL rhThrombin solution (clear and transparent liquid).
15798928|NCT04459871|Biological|placebo|placebo, dissolved in 5mL sterile saline and mixed, the final solution contains 1000IU/mL rhThrombin solution (clear and transparent liquid).
15798929|NCT04459858|Other|data analysis|"Data is extracted from the existing medical records and from the Rotator Cuff Repair Database (RCR_USB). The GTA (determined as the angle between a line parallel to the humerus diaphysis passing through the humeral head center of rotation and a line connecting the upper border of the humeral head to the most superolateral edge of the greater tuberosity) is determined."
15798930|NCT04459845|Behavioral|Parent Child Interaction Therapy|Parent-child Interaction therapy (PCIT; Eyberg and Robinson, 1982) s a manualized evidence-based behavioral parent training program that integrates social learning and attachment theories. Parents proceed through two distinct phases: Child-Directed Interaction (CDI) resembles traditional play therapy, and Parent-Directed Interaction (PDI) resembles clinical behavior therapy. During all sessions, the therapist coaches each parent in vivo in their use of the CDI and PDI skills with their child.
15798931|NCT04459845|Behavioral|Child Parent Psychotherapy|Child-parent psychotherapy (CPP; Lieberman et al., 2005) is a relationship-based treatment that integrates attachment, cognitive-behavioral, social-learning, and psychodynamic theories. CPP focuses on the child-parent relationship as a way to improve the child's adaptive functioning. Various treatment strategies are employed including a focus on safety, affect regulation, the joint construction of a trauma narrative, and engagement in developmentally appropriate activities.
15798932|NCT04459832|Procedure|stretch hamstring|Stretching of the hamstring muscles was performed by the primary researcher. A straight-leg-raising technique was used for this stretch because we believe that it is commonly used in the clinical setting for elderly people. All subjects were supine lying as flat as possible
15798933|NCT04459819|Other|Respiratory physiotherapy|"Respiratory physiotherapy consists of:
~early mobilization (passive and active mobilization, muscle-strengthening exercises, mobilization out of bed, standing, walking, ADL)
~patients positioning
~non-invasive mechanical ventilation / CPAP
~tracheostomy management
~invasive mechanical ventilation weaning
~airway clearance
~oxygen titration"
15798934|NCT04459806|Procedure|intracranial pressure monitoring|Invasive monitoring of intracranial pressure by using CereLink monitor.
15798935|NCT04459780|Biological|Skin biopsies|3 biopsies on lesion skin (and one more for the first fifteen subjects in group 1)
15798936|NCT04459780|Biological|Blood sample|One blood sample for the group 1 only.
15798937|NCT04459767|Drug|Vupanorsen|80 mg subcutaneous injection
15798938|NCT04459767|Drug|Placebo|Subcutaneous injection
15798939|NCT04459754|Drug|Fuzheng Yiliu Formulation|"The prescription for colorectal cancer Fuzheng Yiliu formulation is a combination of 13 herbal components and it is available in granules form to be dissolved in hot water for consumption."
15798940|NCT04459741|Dietary Supplement|Dietary salt (Sodium chloride)|Dietary salt used was sodium chloride tablets (from the research consolidated midland corporation division, New York, USA) which participants crashed and put in their food and/or ingested. Each tablet weighed one (1) gram and contained 394 mg of sodium and 606 mg of chloride.
15798941|NCT04459728|Behavioral|Wellness Element 1: Exercise|Daily wellness element focusing on Exercise; adherence documented online daily
15798942|NCT04459728|Behavioral|Wellness Element 2: Mindfulness|Daily wellness element focusing on Mindfulness Meditation; adherence documented online daily
15798943|NCT04459728|Behavioral|Wellness Element 3 - Sleep Hygiene|Daily wellness element focusing on sleep hygiene; adherence documented online daily
15798945|NCT04459728|Behavioral|Wellness Element 5 - Nutrition|Daily wellness element focusing on nutrition; adherence documented online daily
15798946|NCT04459728|Behavioral|Wellness Element 6 - Wellness Exercises|Daily wellness workbook exercises focusing on improving mental wellness; adherence documented online daily
15798947|NCT04459728|Behavioral|Wellness Element 7 - Motivational Messages|Daily motivational emails offering information on one of the 5 wellness elements each day (Exercise, Mindfulness Meditation, Sleep, Social Connectedness, and Nutrition)
15798952|NCT04459702|Drug|hydroxychloroquine|Treatment with the drug hydroxychloroquine
15798953|NCT04459702|Drug|Azithromycin|Treatment with the drug azithromycin
15798954|NCT04459702|Drug|Ritonavir|Treatment with the drug ritonavir
15798955|NCT04459702|Drug|Lopinavir|Treatment with the drug lopinavir
15798956|NCT04459676|Drug|Standard of Care (SOC) + ANG-3777|Standard of Care (SOC) + ANG-3777
15798957|NCT04459676|Drug|Standard Of Care (SOC) + Placebo|Standard Of Care + Placebo
15798958|NCT04459663|Drug|Toripalimab injection combine with Axitinib|The patients in the group will be infused intravenously with fixed dose of 240mg JS001 on the first day of each cycle. Oral Axitinib 5mg bid (recommended interval of about 12 hours) was given daily from the second day of the initial cycle
15798959|NCT04459650|Procedure|Platelet Rich Plasma system|Participants will receive PRP obtained with PRP harvesting kits on one side of the scalp and no injections on the other side of the scalp (split-scalp technique). The entire half of the intended scalp will receive inter-follicular injections of PRP under aseptic conditions at the amount of 0.05-0.1 ml/cm2 in a retrograde fashion from deep to superficial, at every centimeter throughout the treated site. For study purposes, Study Day 0 is defined as the first day of injection. Subsequently the patient will continue therapy every 4 weeks for a total of 3 injections (12 weeks).
15798960|NCT04459624|Procedure|Erector Spina Plane Block|Group E (ESP block) will be applied 20 ml of % 0.25 bupivacaine between the erector spina muscle and transverse process at the 8th thoracic level. The blocks will be administered under general anesthesia in lateral position by the same anesthesiologist.
15798961|NCT04459624|Procedure|Quadratus Lumborum Block 2|Group Q (QLB2 block) lumbar interfacial triangle (LIFT) will be applied 20 ml of % 0.25 bupivacaine. The blocks will be administered under general anesthesia in lateral position by the same anesthesiologist.
15798962|NCT04459611|Biological|sintilimab|200 mg by IV infusion every 3 weeks (Q3W), given on cycle day 1.
15798963|NCT04459611|Drug|pemetrexed|500 mg/m^2 by IV infusion Q3W, given on cycle day 1.
15798964|NCT04459611|Drug|Carboplatin|AUC 5 mg/mL/min by IV infusion Q3W, given on cycle day 1.
15798965|NCT04459611|Drug|albumin-bound paclitaxel|260 mg/m^2 by IV infusion Q3W, given on cycle day 1.
15798966|NCT04459598|Drug|Efavirenz|Single oral dose, 600-mg tablet
15798967|NCT04459598|Drug|Quizartinib|Single oral dose, 60 mg (2 x 30 mg) tablets
15798968|NCT04459585|Drug|Dabigatran Etexilate Mesylate|Single oral 150 mg capsule dose
15798969|NCT04459585|Drug|Quizartinib|Single oral 60 mg dose of quizartinib administered as two 30 mg tablets (26.5 mg free base per tablet)
15798970|NCT04459572|Diagnostic Test|suPAR|Soluble Urokinase Plasminogen Activator Receptor (suPAR)
15798971|NCT04459559|Device|Tactile Cueing Device|Each participant receives an individual training on how to use the Tactile Cueing Device and the set-up of the TCD will be done according to the results of a 10MWT and the participant's preferences. Gait assessments with an activated or deactivated TCD are executed using the Timed Up and Go test, the 2-Minute Waling test and a treadmill (C-Mill). Also a long-term test run of the TCD during one day is planned.
15798972|NCT04459546|Behavioral|patient education, training booklet, 3 months tele health|Patient education includes general disease information, COPD self-management and symptom control. The education face-to-face and practical training was provided by the researcher. The training booklet was prepared by the researcher. The readability of the booklet was very easy and its comprehensibility was tested by pre-application. Tele monitoring was done by the researcher for support and motivation. The participants were called 4 times by phone.
15798973|NCT04459533|Device|TOF protocol|"To the introduction of CISATRACURIUM, Initial bolus was at 0.2mg/kg and initial continuous infusion at 0.18mg/kg/h of theoretical ideal weight.
~To the introduction of ATRACURIUM, initial bolus was at 0.5mg/kg and initial continuous infusion at 0.5mg/kg/h of theoretical ideal weight.
~Introduction of NMBA was associated to deep sedation (RASS - 4 or RAMSAY 6; BIS 40 to 60).
~TOF was measured through the electric stimulation of peripheral nerves (facial or ulnar nerve).
~The dose of NMB agents was then adapted according to the number of answers to the TOF, per 4 hours:
~If 0 response and no respiratory asynchrony: no change in flow rate
~If >=1 or respiratory asynchrony: increase of the continuous curare flow by 20% preceded by a bolus identical to the one administered at the beginning of NMB agent, then recheck at H+1."
15798974|NCT04459520|Behavioral|Positive COVID Test Result - Hypothetical Scenario|Participants will be asked to imagine that they have tested positive (PCR) for an active COVID-19 infection and that their physician has clinically diagnosed them with COVID-19.
15798975|NCT04459520|Behavioral|Negative COVID Test Result - Hypothetical Scenario|Participants will be asked to imagine that they have tested negative (PCR) for an active COVID-19 infection.
15798976|NCT04459520|Behavioral|Unavailable COVID Test Result - Hypothetical Scenario|Participants will be asked to imagine that testing is not available for active COVID-19 infections but that their physician has clinically diagnosed them with COVID-19.
15799027|NCT04459065|Drug|IRDye800CW-nimotuzumab|50 mg of IRDye800CW-nimotuzumab will be infused intravenously over a period of 30 minutes. Lung cancer resection surgery will be done at different time points post infusion
15799187|NCT04457687|Drug|Lorcaserin|Lorcaserin 10 milligram (mg) tablets orally.
15798978|NCT04459494|Procedure|Flapless implant surgery.|"Local anesthesia will be applied to the patients in the test group, and then the implant socket will be prepared without removing the flap and a dental implant will be placed.
~Bite-wing film will be taken to control the implants in the same session after surgery, and patients will be given VAS (visual analog scale) to perform their assessment of pain on the 3rd day and 7th day. Patients will be given an appointment again after 3 months of treatment. In this session, implants will be evaluated with bite-wing film."
15798979|NCT04459494|Procedure|Conventional implant surgery.|"Local anesthesia will be applied to the patients in the control group, and then the implant socket will be prepared after reflecting the flap and a dental implant will be placed.
~Patients in the control group will receive a full thickness flap elevation and an implant socket will be prepared afterwards the implant will be placed and then the flap will be closed with 4-0 silk suture.
~Bite-wing film will be taken from both groups to control the implants in the same session after surgery, and patients will be given VAS (visual analog scale) to perform their assessment of pain on the 3rd day and 7th day. Patients will be given an appointment again after 3 months of treatment. In this session, implants will be evaluated with bite-wing film."
15798980|NCT04459481|Device|bending angle|patients in 70-degree bending angle group are intubated with video stylet at 70-degree bending angle patients in 90-degree bending angle group are intubated with video stylet at 90-degree bending angle
15798981|NCT04459468|Drug|Lipiodol|Lipiodol TACE procedure
15798982|NCT04459455|Behavioral|Contain COVID Anxiety SSI|Participants first receive normalizing scientific information (including neuroscience findings) that help explain why increased anxiety during the COVID-19 is a typical response. They then read testimonials from three other people around the world who have applied a 3-step action plan for coping more effectively with their anxiety. The entire intervention takes approximately 8 minutes and is completely entirely within the Qualtrics survey platform.
15798983|NCT04459455|Behavioral|Remain COVID Free SSI|This placebo SSI was developed to mirror the structure of the Contain COVID Anxiety SSI, discuss COVID-19 related content, and do so without as many of the potential active ingredients of effective SSIs. Participants will receive scientific information about how soap kills the COVID-19 virus, but no neuroscience information related to behaviors or behavior change.
15798984|NCT04459442|Procedure|Umbilical cord clamping at birth.|Umbilical cord clamping after delivery.
15798985|NCT04459429|Device|Change of cannula size|During nasal High Flow Therapy with fixed flow of 8 l/min, the cannula size will be changed from smaller-to-larger or larger-to-smaller
15798986|NCT04459416|Other|Acupuncture|Acupuncture treatments will be scheduled to cover the period of high symptom burden. Acupuncture will start on Day 0 and continue once daily to Day 15, as long as the patient is inpatient or comes to the clinic for post-transplantation follow-up. Electrical stimulation (e-acupuncture) may be applied to the ST36 and SP6 points when appropriate as per standard acupuncture practice.
15798987|NCT04459416|Drug|opioid|All study patients will receive the usual HSCT care and pain management regimens (usually opioids) as per standard practice at the study institution.
15798988|NCT04459416|Other|Assessments|Participants will be asked to complete patient reported outcomes assessments online using REDCap or, If they prefer, via pencil and paper or over the phone. Assessments at baseline (within 4 weeks before HiChemo) and on or about days 7, 15, 30, and 90 after the first dose of HiChemo.
15798989|NCT04459390|Diagnostic Test|realtime PCR|Detection of SARS-CoV-2 genes by realtime PCR
15798990|NCT04459377|Drug|S-Ketamine|"Patients are randomized to three groups. Randomization in blocks of six patients stratified by sex. A list of serial numbers and randomized group affiliation is produced which is open to the pharmacy's manufacturing staff and closed to the staff of the trial. The pharmacy prepares filled syringes with investigation drug in accordance with randomized group affiliation.
~All groups are sedated with midazolam intravenously to a defined end point. A syringe pump with volume accuracy ± 2% injects the test drug (P, K1 or K2). One infusion set is coupled between the syringe and a three-way connection, which in turn is connected to a peripheral venous catheter (PVK). This PVK is also used for blood sampling. Blood is sampled at two occasions. Directly preoperatively and two hours after surgery. The third molar is surgically removed."
15798991|NCT04459377|Drug|Sodium Chloride 0.9% Inj|"Patients are randomized to three groups. Randomization in blocks of six patients stratified by sex. A list of serial numbers and randomized group affiliation is produced which is open to the pharmacy's manufacturing staff and closed to the staff of the trial. The pharmacy prepares filled syringes with investigation drug in accordance with randomized group affiliation.
~All groups are sedated with midazolam intravenously to a defined end point. A syringe pump with volume accuracy ± 2% injects the test drug (P, K1 or K2). One infusion set is coupled between the syringe and a three-way connection, which in turn is connected to a peripheral venous catheter (PVK). This PVK is also used for blood sampling. Blood is sampled at two occasions. Directly preoperatively and two hours after surgery. The third molar is surgically removed."
15798992|NCT04459338|Biological|Exendin-9,39|Exendin-9,39 is a competitive antagonist of GLP-1 actions at the GLP-1 receptor
15798993|NCT04459338|Other|Saline|Placebo comparator
15798994|NCT04459325|Biological|Tigerase® and best available care|Nebulised dornase alfa [2.5 mg BID] for 7 days
15798995|NCT04459325|Other|Best available care|Patients will receive the usual care in accordance with good practice.
15798996|NCT04459312|Diagnostic Test|Antibody test (SARS-CoV2)|Antibody test
15798997|NCT04459299|Procedure|Robotic-PCI (CorPath GRX System)|Robotic-PCI for acute ST elevation myocardial infarction (STEMI).
15798998|NCT04459286|Drug|Nitazoxanide and atazanavir/ritonavir|1000 mg nitazoxanide tablets twice daily and 300/100 mg atazanavir/ritonavir tablets once daily with meal
15798999|NCT04459286|Other|Standard of Care|SOC will be as determined by the clinical team at the treatment centres in line with the current National Interim Guidelines for Clinical Management of COVID-19
15799000|NCT04459273|Procedure|Computed Tomography|Undergo PET/CT
15799001|NCT04459273|Drug|Gallium Ga 68 FAPi-46|Given IV
15799002|NCT04459273|Procedure|Positron Emission Tomography|Undergo PET/CT
15799099|NCT04458519|Other|Probiorinse|Nasal irrigations with probiotic twice-daily for a period of fourteen days
15799003|NCT04459260|Behavioral|Cognitive Behavior Therapy|"A standardized evidence-based treatment manual based on cognitive behavior therapy, developed specifically for targeting perfectionism (Egan et al., 2016). Includes the following components: 1) providing psychoeducation about perfectionism and creating an individualized conceptualization 2) broadening the domains for self-evaluation 3) testing out beliefs and predictions, and 4) addressing personal standards and self-criticism.
~Week 1: Understanding your perfectionism.
~Week 2: Your own model, values, and motivation.
~Week 3: Surveys and experiments.
~Week 4: Dealing with perfectionistic behaviors.
~Week 5: New ways of thinking.
~Week 6: Self-criticism and self-compassion.
~Week 7: Self-worth.
~Week 8: Maintain and continue positive change."
15799004|NCT04459260|Behavioral|Unified Protocol|"A standardized evidence-based treatment manual based on cognitive behavior therapy, developed to target the shared emotional factors in depression and anxiety disorders (Ellard et al., 2010). Fundamental to this approach is to register and become more aware of the emotions, cognitions, and physical sensations that occur in difficult situation, and to try out more adaptive ways of coping in these instances.
~Week 1: Emotional symptoms.
~Week 2: Understanding your emotions.
~Week 3: Emotional awareness.
~Week 4: Thoughts.
~Week 5: Behaviors.
~Week 6: Emotional exposure.
~Week 7: Continued emotional exposure.
~Week 8: Planning ahead."
15799005|NCT04459247|Drug|Vit D|Oral liquid formulation of 60000 IU
15799006|NCT04459234|Drug|Ketamine use in CLCC sites (indication and administration protocol)|"Collection of information concerning Ketamine use by French CLCCs pain teams (first prescription):
~Indications : analgesic treatment of cancer chronic pain, analgesic treatment for a post-cancer treatment chronic pain, help for withdrawal from opioid treatment prescribed for a chronic cancer pain
~Administration protocol: route, posology, duration, administration sequence, premedication
~Antalgic efficacy
~Tolerance profile
~Quality of life, anxiety and depression evaluations"
15799007|NCT04459221|Drug|Gardasil 9, 9-Valent Intramuscular Suspension|access to HPV vaccination near the college in a health bus
15799008|NCT04459208|Device|Manta|plug-based vascular closure
15799009|NCT04459208|Device|ProGlide|suture-based vascular closure
15799010|NCT04459195|Behavioral|2 Minute Static Stretching|Stretching applications will be applied to the first group for 2 minutes. Static stretching exercise will be performed under the supervision of a physiotherapist as 30 seconds of stretching and 30 seconds of rest and and the individuals will be asked to participate in the exercise actively.
15799011|NCT04459195|Behavioral|5 Minute Static Stretching|Stretching applications will be applied to the first group for 5 minutes. Static stretching exercise will be performed under the supervision of a physiotherapist as 30 seconds of stretching and 30 seconds of rest and and the individuals will be asked to participate in the exercise actively.
15799012|NCT04459182|Diagnostic Test|ENDOPAT|digital plethysmography
15799013|NCT04459169|Procedure|diagnostic algorithm|Cardiac amyloidosis diagnosed according to Gillmore's algorithm
15799014|NCT04459156|Dietary Supplement|Fiber Inulin|Commercially available inulin is provided as powder. The following doses will be administered twice daily (with breakfast and dinner): Day 1-2: 5-g; Day 3: 7.5-g; Day 4: 10-g; Day 5: 12.5-g; Day 6-7: 15-g. All supplements are commercially available.
15799015|NCT04459156|Dietary Supplement|Placebo Maltodextrin|Commercially available maltodextrin is provided as powder. The following doses will be administered twice daily (with breakfast and dinner): Day 1-2: 5-g; Day 3: 7.5-g; Day 4: 10-g; Day 5: 12.5-g; Day 6-7: 15-g. All supplements are commercially available.
15799016|NCT04459143|Behavioral|Advance directives|A workshop will take place during the third week of patient care to inform them about COPD, exacerbations, prognostic and advance directives. Then, a personal interview with patients who have participated to this workshop will take place at the end of their hospital stay, to collect their advance directives and their degree of satisfaction about this process.
15799017|NCT04459130|Behavioral|Child Obesity Program|"The program consists of 10 sessions, each lasting 40 minutes. An EOP booklet containing session programs will be distributed to children.
~The topics of the sessions are as follows:
~Session 1: Healthy lifestyles
~Session 2: Self-esteem and positive thinking, Setting goals Session 3: Stress and Coping, Coping with Emotions in Healthy Ways Session 4: Personality and effective communication
~Session 5: Activity: Time for action Session 6: Nutrition basics Session 7: Reading tags Session 8: Portion size, nutrition and healthy food choices in schools Session 9: Snacks can also be healthy: Healthy choices
~Session 10: Together for a healthy life (Melnyk et al., 2006; 2007; 2009). Detailed information about the sessions is given in annex -3."
15799018|NCT04459117|Drug|Acetaminophen|"In the 27-28 weeks gestational age group, the dosage is 2 ml/kg loading dose within 12 hours after birth followed by 0.75 ml/kg/ 6 hours during 5 days (total = 20 doses).
~In the 23-26 weeks gestational age group, the dosage will be minimum effective dose of acetaminophen to close the ductus arteriosus before or at day 7, found during the phase II."
15799019|NCT04459117|Drug|NACL 0.9%|"In the 27-28 weeks gestational age group, the dosage is 2 ml/kg loading dose within 12 hours after birth followed by 0.75 ml/kg/ 6 hours during 5 days (total = 20 doses).
~In the 23-26 weeks gestational age group, the dosage will be minimum effective dose of acetaminophen to close the ductus arteriosus before or at day 7, found during the phase II."
15799020|NCT04459104|Other|Low glycemic load|Participants will be given test beverages containing 50gr of isomaltulose (low glycemic index = 32). Isomaltulose powder will be dissolved in 250mL water, and participants will be instructed to consume this beverage within 5 minutes. Blood glucose levels will be collected at 15, 30, 45, 60, 90, and 120 minutes after consumption of the beverages. The first two drops of blood will be discarded, the third drop will be used for testing.
15799021|NCT04459104|Other|High glycemic load|Participants will be given test beverages containing 50gr sucrose (high glycemic index = 65). Sucrose powder will be dissolved in 250mL water, and participants will be instructed to consume this beverage within 5 minutes. Blood glucose levels will be collected at 15, 30, 45, 60, 90, and 120 minutes after consumption of the beverages. The first two drops of blood will be discarded, the third drop will be used for testing.
15799024|NCT04459078|Drug|Camrelizumab|Intravenous administration of (200mg/3weeks)
15799025|NCT04459078|Drug|Albumin Paclitacxel|intravenous administration of Albumin Paclitacxel (135mg/m2, d1, d8/3w, 4-6 cycles)
15799026|NCT04459078|Drug|Apatinib|Patients will be given oral of Apatinib (250mg Qd po for 5 days, take rest for 2 days every week)
15799030|NCT04459039|Drug|1000 mL 0.9% sterile saline|Within 12 h of surgery, the experimental group received 1000 mL 0.9% sterile saline intravenously.
15799031|NCT04459039|Drug|250 mL 0.9% sterile saline|Within 12 h of surgery, the control group received 250 mL 0.9% sterile saline intravenously.
15799032|NCT04459026|Procedure|combination|instillation and infiltration of ropivacaine
15799033|NCT04459026|Procedure|infiltration|local infiltration ropivacaine
15799034|NCT04459026|Procedure|instillation|intraperitoneal ropivacaine instillation
15799035|NCT04459013|Other|Salivary samples|The salivary samples will be collected at 5 defined times
15799036|NCT04459000|Behavioral|STARS + maternal Attachment Biobehavioral Catchup home visiting model|Mothers receive up to 12 home visits from a licensed therapist focused on attachment and positive parenting in substance exposed babies. This includes 1 prenatal home visit and up to 11 postnatal visits.
15799037|NCT04459000|Behavioral|STARs Only|Participants receive prenatal care in the STAR clinic (a clinic specifically designed to support mothers with substance abuse who are at risk of losing their children to child welfare at birth).
15799039|NCT04458974|Device|Transcranial direct current stimulation|"The intervention consists in two-weeks treatment, 10 consecutive sessions of tDCS ( Monday to Friday) applied concurrently to neuropsychological rehabilitation.
~The tDCS Multisite StratStim® 8-channel device (Neuroelectrics) will be used for tDCS stimulation. The duration of the stimulation will be 20 minutes at 2 mA. The tDCS will be applied with the cathode positioned in P3 (following the international 10/20 EEG system), and the return electrodes will be placed in C3, CP5, CP1, Pz, PO3, PO7, P7.
~The sessions will last 1 hour."
15799040|NCT04458974|Procedure|Neuropsychological rehabilitation|"The neuropsychological rehabilitation protocol has been designed for the recovery of neglect symptomatology. Each session will consist on the performance of different cognitive stimulation tasks aimed at improving attention and visoperceptive abilities. The tasks will be applied through the NeuronUp neurorehabilitation platform in order to achieve maximum homogeneity and objectivity across patients.
~The neuropsychological rehabilitation will last 30min (in 1h intervention session)."
15799041|NCT04458961|Procedure|One-stage|A one-stage revision operation involves one operation to remove the joint, thoroughly cleaning the infected area and then implanting a new joint immediately.
15799042|NCT04458961|Procedure|Two-stage|A two-stage revision operation involves two operations: the joint is removed in one operation, a temporary spacer device is inserted, then the infection is treated with antibiotics, and then a new joint is implanted in a second operation.
15799043|NCT04458948|Drug|Hydroxychloroquine|Hydroxychloroquine 400 mg BID, on day 1 and then 200 mg BID day 2 through 7 IV or po for 5 days. If the condition of the patient does not allow for oral therapy, HCQ can be given via a feeding or NG tube. Azithromycin can be given intravenously.
15799044|NCT04458948|Drug|Azithromycin|Azithromycin 500 mg, IV or po for 5 days
15799045|NCT04458922|Drug|Atezolizumab|Given IV
15799046|NCT04458909|Drug|Carboplatin|Given IV
15799047|NCT04458909|Drug|Cisplatin|Given IV
15799048|NCT04458909|Drug|Gemcitabine|Given IV
15799049|NCT04458909|Biological|Nivolumab|Given IV
15799050|NCT04458909|Other|Questionnaire Administration|Ancillary studies
15799051|NCT04458896|Behavioral|Stand When You Can|"Intervention strategies can be customized to different environments based on consultation with management. Some strategies will be mandatory:
~Education session: group information session during the first week of the intervention (30min) to discuss sedentary time (ST), health risks, strategies to reduce ST, goal setting, & the identification of barriers and motivators to reducing ST. Group discussion will be encouraged to increase self-motivation and self-efficacy. An information workbook will be given to each attendee for their personal use and goal setting.
~Point of decision prompts (ie: signs that encourage standing; see attachments) will be placed in common areas of the facility, and/or given as pamphlets to residents.
~An intervention package will be provided to the Activity Coordinator and Manager of the facility. This package will provide an introductory letter along with materials to promote reduced sedentary time in the facility"
15799052|NCT04458883|Procedure|Cardiac Magnetic Resonance Imaging|Cardiac Magnetic Resonance Imaging - Cardiac Scan
15799053|NCT04458883|Procedure|Fast Field Cycling - Magnetic Resonance Imaging|Fast Field Cycling - Magnetic Resonance Imaging Cardiac Scan
15799054|NCT04458883|Procedure|Electrocardiogram|Electrocardiogram
15799055|NCT04458883|Procedure|Echocardiogram|Echocardiogram
15799056|NCT04458870|Behavioral|Acceptance and Commitment Therapy|Participants will receive 10 weekly individual acceptance and commitment therapy by a trained coach through zoom video-conferencing.
15799057|NCT04458857|Drug|Fremanezumab|Dose A or Dose B subcutaneous
15799058|NCT04458857|Drug|Placebo|Matching placebo
15799059|NCT04458844|Other|Exercise|Intervention programmes were designed based on previous research (Duncan, et al., 2017; Faigenbaum, et al., 2011; Miller, et al., 2006) to ensure all exercises were developmentally appropriate for the age of the participants (an example session plan can be seen in the supplementary material). Each session consisted of five activities and lasted 50 - 60 minutes. Three out of the five activities were identical for the FMS and FMS+ groups, while two differed focusing on skill development for the FMS group and strength development for the FMS+ group. The FMS and FMS+ group received their sessions twice a week for 4 weeks. The sessions were delivered at least 48 hours apart to allow recovery and to reduce the risk of fatigue effecting performance (Faigenbaum, et al., 1996). All sessions were led by a researcher and a qualified sports coach.
15799064|NCT04458818|Procedure|Prolene Mesh Vocal Cord Medialization Implant|The surgery will be performed under local anesthesia (lignocaine with adrenaline 2%) and procedural sedation with propofol 25-100mcg/kg/min (only sedative dose) will be administered, so that the patient remains vocally responsive during the procedure. Incision will be made at the lower border of thyroid cartilage under aseptic measures. Skin flaps will be raised in sub-platysmal plane, strap muscles will be separated in the midline to expose the laryngeal cartilaginous framework. A simple laryngeal window approach will be used to place the Ethicon prolene mesh 6 x 6cm Swiss roll, secured with prolene 2/0 suture trimmed to the required size. Post op voice analysis will be done on 7th day and 14th post-operative day. Monthly follow up will be advised after that.
15799065|NCT04458805|Drug|NX-13 250 mg|"Dose escalation in Part A will be conducted in a total of 5 cohorts (Cohorts 1 to 5). Seven participants will be enrolled in each cohort and will be randomized to receive either NX-13 or placebo (ratio 5:2). NX-13 will be administered to Cohort 1 participants at the starting dose of 250 mg. The NX-13 dose will be increased in each new cohort. Five nominal dose levels in the range of 250 to 4000 mg have been selected for evaluation in Part A.
~It is anticipated that 3 dose levels will be evaluated in Part B in a total of 3 cohorts (Cohorts 6 to 8). Seven participants will be enrolled in each cohort and will be randomized to receive a single oral dose of either NX-13 or placebo (ratio 5:2), once daily for seven days."
15799066|NCT04458805|Drug|Placebo|"Dose escalation in Part A will be conducted in a total of 5 cohorts (Cohorts 1 to 5). Seven participants will be enrolled in each cohort and will be randomized to receive either NX-13 or placebo (ratio 5:2). NX-13 will be administered to Cohort 1 participants at the starting dose of 250 mg. The NX-13 dose will be increased in each new cohort. Five nominal dose levels in the range of 250 to 4000 mg have been selected for evaluation in Part A.
~It is anticipated that 3 dose levels will be evaluated in Part B in a total of 3 cohorts (Cohorts 6 to 8). Seven participants will be enrolled in each cohort and will be randomized to receive a single oral dose of either NX-13 or placebo (ratio 5:2), once daily for seven days."
15799067|NCT04458792|Other|Paraffin tissue samples|Paraffin tissue samples collected during surgery (neoplasic tissue and normal tissue
15799068|NCT04458792|Other|blood sample|MDM2 project : Blood samples collected at different times : Before the surgery, and 1 month after the surgery circulant DNA project : Blood samples collected at different times : Before the surgery, and 1 month after the surgery radiotherapy toxicity : Blood samples collected before the radiotherapy
15799069|NCT04458779|Device|CPAP|CPAP will be given after obstructive sleep apnea being diagnosed in the acute stage of stroke.
15799070|NCT04458766|Behavioral|Monetary incentives|This intervention will assess the efficacy of subjects using the Wellth mobile phone application to provide reminders to take their statin medication, and receiving monetary incentives for taking their medication as prescribed.
15799071|NCT04458753|Other|Lumbar focused exercises|Transersus abdominis activation Multifidus activation Back extension exercise Curl up abdominal exercise
15799072|NCT04458753|Other|Knee focused exercises|Strengthening of quadriceps Stretching of calf and Hamstring muscles
15799073|NCT04458740|Other|biographical interviews|A sociologist trained in the sociology of cancer, to enable participants to talk about their experiences and clearly distinguish the experiences of each individual
15799074|NCT04458714|Procedure|Aortoiliac angioplasty|In the CO2 arm we used manual injection of CO2 from a medicinal CO2 cylinder connected to a particle filter. Under water aspiration was used to prevent air contamination. Using a twenty mls syringe the required amount of CO2was aspirated using a three way tap and was followed my aspirating 3mls of saline to provide a fluid barrier. In the ICM arm the injection of contrast was done using 10-ml syringes with 5 mls of iodinated contrast media and 5 mls of saline solution per injection. The ICM used in all cases was Omnipaque 300 (Iohexol), a nonionic low osmolar contrast commonly in use in both hospitals.
15799075|NCT04458701|Device|Hemodynamic monitoring|This is a comprehensive hemodynamic management strategy that would-be initiated in the operating room post-bypass and then continued for the first 12 hours in the intensive care unit
15799076|NCT04458688|Other|Observation of Ocrelizumab as Treatment in RRMS Patients|It is decided by the patient and their physician to begin taking ocrelizumab PRIOR to study enrollment. The study is only observing the effects of ocrelizumab as a pre-decided treatment option for a patient's MS.
15799077|NCT04458675|Device|Vibrant capsule|The capsule vibration mechanically stimulates the inner wall of the GI and stimulates motility
15799078|NCT04458675|Drug|Placebo|A biodegradable capsule, which visually similar to the Vibrant active capsule
15799079|NCT04458662|Procedure|Interval running protocol / eccentric-based resistance exercise protocol|
15799080|NCT04458649|Device|Dexcom continuous glucose monitor|Measurement of interstitial glucose
15799081|NCT04458636|Drug|Prednisolone|Oral
15799083|NCT04458610|Biological|Rituximab|Given IV
15799084|NCT04458610|Drug|Zanubrutinib|Given PO
15799085|NCT04458597|Radiation|Image-guided adjuvant pelvic radiotherapy|Image-guided adjuvant pelvic radiotherapy delivered at an SBRT prescription dose of 30 Gy in 5 fractions if feasible, well-tolerated and effective for the adjuvant treatment of high-risk endometrial cancer.
15799086|NCT04458584|Procedure|Trapeziectomy with ligament reconstruction (I; LRTI)|Thumb basal joint arthroplasty (surgical) using Trapeziectomy with ligament reconstruction (I; LRTI)
15799087|NCT04458584|Procedure|Trapeziectomy with suture suspensionplasty (II; SS)|Thumb basal joint arthroplasty (surgical) using Trapeziectomy with suture suspension-lastly (II; SS)
15799088|NCT04458584|Procedure|Arthroscopic Trapeziectomy (III; AT)|Thumb basal joint arthroplasty (surgical) using Arthroscopic Trapeziectomy (III; AT)
15799089|NCT04458558|Drug|Mifepristone|Participants will receive mifepristone at a preferred address by mail rather than standard care at clinic visit.
15799090|NCT04458545|Drug|Placebo|Intranasal placebo 0mg
15799091|NCT04458545|Drug|Oxy 25 mg|Intranasal oxycodone 25mg
15799092|NCT04458545|Drug|OXY 50 mg|Intranasal oxycodone 50mg
15799093|NCT04458545|Drug|OXY 100 mg|Intranasal oxycodone 100mg
15799094|NCT04458545|Drug|Heroin|Intranasal heroin 100mg
15799095|NCT04458532|Other|Aerobic Training|300 min/wk for 16 weeks
15799096|NCT04458532|Other|Aerobic Training|150 min/wk for 32 weeks
15799097|NCT04458532|Other|Aerobic Training|300 min/wk for 32 weeks
15799100|NCT04458519|Other|Saline solution|Nasal irrigations with saline-only twice-daily for a period of fourteen days
15799101|NCT04458506|Procedure|Maxillary expansion|Correction of the unilateral posterior cross bite in children
15799102|NCT04458493|Behavioral|satiety|satiety ratings, appetite and desire to eat (10-point visual analogue scale) will be measured at 30, 60 and 120 minutes after each meal replacement drink
15799103|NCT04458493|Dietary Supplement|Dietary Supplement: Generation UCAN supplementation|meal replacement, Generation UCAN supplement, 400ml, 20% solution
15799104|NCT04458480|Combination Product|Fast Inpatient Rehabilitation|Routine inpatient rehabilitation protocol, administered by licensed Physical Therapist, duration period of 1.5h-2h each time, 2 times for weekdays and 1 time for weekends, totally lasting for 1 week, are applied to the exposed group. After the fast inpatient rehabilitation for 1 week, the patients can get discharged if reaching to the rehabilitation goals of symptoms of pain and swell reduced, knee flexion ≥ 90° and knee extension ≥ 0°, quadriceps femurs and hamstrings muscle strength enhanced, recovery to aided standing and walking, and acquiring of rehabilitation training methods.
15799105|NCT04458467|Device|Continuous Infusion|A continuous infusion of ropivacaine 0.2% (6 mL/hr, 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room.
15799106|NCT04458467|Device|Automated Intermittent Boluses|Administration of automated intermittent boluses of ropivacaine 0.2% (8 mL every 2 hr with 4 mL patient controlled bolus with 30-minute lockout) will be initiated in the recovery room, but with a 5-hour delay for the first bolus (can be overridden by patients if they would like to initiate their perineural infusion earlier than 5 hours).
15799107|NCT04458454|Diagnostic Test|Relaxin ELISA Kit|Ovarian stimulation was carried out from day 3 of the menstrual cycle using a fixed protocol, with recombinant (Gonal-F, Pergoveris) or human menopausal gonadotropins (Meriofert), GnRH antagonist (ganirelix 0.25 mg). A recombinant human chorionic gonadotropin Ovitrel 250 μg or a GnRH agonist, Diferelin 0.2 mg, was used as an ovulation trigger.
15799108|NCT04458441|Other|warm group/cold group|sequential randomization
15799109|NCT04458428|Other|SMS|"Patients who are randomized to the intervention arm will be signed up for the automated SMS program. This cohort will receive text messages after surgery, timed from the day of discharge through 14 days post-op. Patients in this cohort will receive text messages each day. The number of text messages varies on patient interest and yes responses to see additional information."
15799110|NCT04458415|Other|Traxi Panniculus Retractor (TPR)|Surgeon uses the Traxi Panniculus Retractor (TPR) surgical retraction device to retract the panniculus during C-Section.
15799111|NCT04458415|Other|Silk Tape|Surgeon uses silk tape to retract the panniculus during C-Section.
15799112|NCT04458402|Radiation|Hypofractionated WPRT|Cohort 1: 41.25 Gy in 15 fx Cohort 1: 38 Gy in 10 fx
15799113|NCT04458389|Drug|TY101|"Dose escalation: TY101 0.3mg/kg or 1mg/kg or 3mg/kg or 10mg/kg 200mg Intravenous Q3W, 2 years depending on response.
~Dose expansion: Subjects received TY101 injection for a maximum of 2 years until progressive disease, intolerant toxicity, death, or withdrawal from the study occurred."
15799114|NCT04458376|Behavioral|Internet-based self-help program|The program is divided into six short weekly lessons providing information about chronic dizziness and vestibular rehabilitation, and demonstrating the exercises by video. The program is freely available in the Norwegian electronic handbook for physicians (NEL). The participants in the study will receive the internet address after inclusion in the study.
15799115|NCT04458363|Biological|Convalescent Plasma (CP)|Once the patient meets criteria for CP infusion (severity of disease and risk factor determination and absence of exclusion criteria), an ABO compatible product will be identified. The CP dose administered will be 10mL/kg/dose (up to 2 units per dose) times two doses per patient for a total dose of 20 mL/kg. Patients will be followed for adverse events and clinical response. Research blood testing will be obtained prior to infusion (baseline) and serially weekly afterwards until clinical resolution. Patients will receive 2 doses equaling 20 mL/kg (if available) of ABO compatible CP over 24-48 hours if they do not experience grade 3-5 adverse events that are possible, probably, or definitely attributed to CP after the first dose. Patients will be followed for adverse events for a minimum of 28 days after the last infusion of CP.
15799116|NCT04458363|Drug|Standard COVID-19 therapies|If clinical status permits, administration of additional COVID-19 therapies should be delayed 48 hours or more from CP infusion completion. Supportive care will be administered by best clinical practice.
15799117|NCT04458350|Behavioral|Digital Promotions Group|Digital promotions on the Fresh EBT app and Facebook will run for 13 weeks, advertising a SNAP fruit and vegetable incentive at farmers' markets in New England. The intervention will be applied to zip codes randomized to the intervention arm.
15799118|NCT04458324|Drug|Buspirone Hydrochloride|Subjects take 30 mg buspirone HCl twice a day for 6 months.
15799119|NCT04458324|Drug|Buspirone placebo|Subjects take a placebo tablet twice a day for 6 months.
15799120|NCT04458324|Device|Noninvasive Ventilation (NIV)|The ventilator will be set in spontaneous mode with a ramp to reach a minimal pressure of 12 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.
15799121|NCT04458324|Device|Sham Non-invasive ventilation (NIV)|The ventilator will be set in spontaneous mode with a ramp to reach a maximal pressure of 5 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.
15799122|NCT04458324|Other|Functional Electrical Stimulation Row Training (FESRT)|Subjects participate in a supervised exercise training program 2-3 times/week for 6 months using an adapted indoor rower and FES.
15799123|NCT04458311|Drug|Abiraterone Acetate|Supplied as 125 mg tablets
15799124|NCT04458311|Drug|Tildrakizumab|Tildrakizumab will be supplied in single-use 100 mg/mL glass vials intended for IV infusion.
15799125|NCT04458298|Drug|OP-101|OP-101 infusion will be administered intravenously.
15799126|NCT04458298|Drug|Placebo|Matching placebo infusion will be administered intravenously.
15799127|NCT04458285|Drug|Sacubitril / Valsartan Oral Tablet [Entresto]|Patients in experimental group will receive sacubitril/valsartan with the recommended starting dose: 50mg twice daily (if previous ACEI, ensure 36-hour washout period), after 2-4 weeks, the dose will be doubled to the target maintenance dose of 100mg twice daily(if tolerated) for 12 weeks.
15799128|NCT04458285|Drug|Valsartan 80mg Tablet|Patients in active comparator group will receive Valsartan with an dose of 80 mg once daily.
15799129|NCT04458272|Drug|DS-1001b|250 mg, twice daily, continuous oral administration
15799133|NCT04458246|Other|Exercise training group|Online aerobic home-based exercise training, 3 times per week, during 3 months. The exercise program is composed by 3 levels (starter, intermediate and advanced) which be completed in the first, second and third month of intervention, respectively.
15799134|NCT04458233|Procedure|long axis FNA method|"). A long-axis view (i.e., a longitudinal image of the needle) is obtained by placing the US probe in a parallel position relative to the course of the needle. Short-axis and long-axis views can be used for both US assistance and guidance of FNA procedure. Correspondingly, approaching the nodule with the needle from the lateral or frontal aspect results in either a long axis or short axis view of the needle on the US screen"
15799136|NCT04458207|Procedure|Oral prosthetic rehabilitation|Individual treatment options will be discussed with the participants individually and rehabilitation will be provided as agreed by the dentist and the participant. The rehabilitation will include fixed prosthodontics. The procedures will involve a control phase involving scaling, root planing oral hygiene instructions etc., extractions and bone augmentation when needed and temporary removable dentures. Restoration of the lost vertical dimension (if needed) with occlusal splints, tooth preparations, placement of dental implants (if needed) and finally cementation of dental crowns. The rehabilitation phase is estimated to take approximately 3-18 months, or more.
15799137|NCT04458194|Other|Standard Care|Standard Care is used as a control condition. Cancer survivor-caregiver dyads assigned to this arm continue to do what they would normally in their lives and standard care will be provided for the cancer survivor.
15799138|NCT04458194|Behavioral|Partnered Yoga|Partnered Yoga for Cancer Survivors, YOCAS©®, intervention is a low to moderate intensity mode of exercise that draws from two basic types of yoga; gentle Hatha and Restorative yoga. The program includes specific physical postures and mindfulness exercises focused on breathing and meditation. Cancer survivors and their caregivers will participate in 8 virtual Zoom YOCAS sessions (75 minutes/session, 2 times a week for 4 weeks) together.
15799139|NCT04458194|Behavioral|Non-partnered yoga|Non-partnered Yoga for Cancer Survivors, YOCAS©®, Intervention is a low to moderate intensity mode of exercise that draws from two basic types of yoga; gentle Hatha and Restorative yoga. The program includes specific physical postures and mindfulness exercises focused on breathing and meditation. Cancer survivors will participate in 8 virtual Zoom YOCAS sessions (75 minutes/session, 2 times a week for 4 weeks) along; caregivers do not receive virtual Zoom YOCAS sessions.
15799140|NCT04458181|Behavioral|Positive Peer Journaling (PPJ)|"PPJ is a journaling practice to support addiction recovery. PPJ encourages past 24 hour review and upcoming 24 hour planning to improve subjective wellbeing in recovery and reduce relapse. PPJ uses journals with column headings under which individuals make bullet-pointed lists. On the left hand page, past 24 hours is recalled, itemizing good and bad things that happened and things for which one is grateful. Good wishes for others are also expressed on this page. On the right hand page, values-based activities for the upcoming 24 hours are planned via headings representing valued life domains such as recovery, work/school, spirituality, home and household, and health."
15799141|NCT04458168|Behavioral|Use of Purposeful app|"Patients will be asked to use the Purposeful app every day, which should take no longer than 5 minutes. The app includes three key components: Explore, Act and Reflect. The Explore section provides thematically organized resources that suggest discrete actions users can try out and potentially incorporate into their lives. The app uses machine learning to customize resources presented to the user. The Act section is where users place actions they'd like to keep track of or build into a habit. Finally, the Reflect section includes daily reflections where the patient answers open ended questions regarding their alignment with their best self qualities, their sense of purpose, and more. Depending on whether users choose to allow push notifications, they will be notified daily to complete morning, afternoon, and/or evening reflections.
~Participants will complete questionnaires at enrollment and at 1, 3, and 6 months after enrollment."
15799142|NCT04458155|Device|Siemens® Point-of-care high sensitive troponin I analyzer|Point-of-care (POC) high sensitive troponin I (HS cTnI) analysis in whole blood, plasma and capillary whole blood with the Siemens® device.
15799143|NCT04458142|Other|Single buccal infiltration|painless technique for palatal anesthesia,single injection,single puncture given
15799144|NCT04458129|Drug|Treatment with polyethylene glycol (Macrogol 4000)|3-month treatment with polyethylene glycol (Macrogol 4000), powder for oral solution, in 4g and 10g sachets. Dosage of 0.7 g/kg/day, with a maximum dose of 20 g/day.
15799145|NCT04458116|Dietary Supplement|Curcumin|Participants will receive 1.5 grams of turmeric 95% curcumin for 1 month (3 capsules / day containing 500mg each for 4 weeks).
15799146|NCT04458103|Device|Percutaneous RVAD|ProtekDuo or Impella RP
15799147|NCT04458090|Behavioral|A decision aid for patients considering Hospice care.|A 12 page booklet and 17 min video describing hospice care
15799148|NCT04458077|Behavioral|Discover Learning (SEIL)|This mobile-phone-based intervention will assess the effectiveness of 10 SEIL sessions conducted at the household level with VYAs. Activities were designed to be done individually, with siblings/peers, and with parents/caregivers. This intervention will look at how household composition and types of practice that can enhance SEIL learning.
15799149|NCT04458064|Other|LMA i gel|insertion of LMA for maintaining airway during anesthesia
15799150|NCT04458051|Drug|Tolebrutinib|Pharmaceutical form: Film-coated Tablet Route of administration: Oral
15799151|NCT04458051|Drug|Placebo|Pharmaceutical form: Film-coated Tablet Route of administration: Oral
15799152|NCT04458038|Other|driving simulator|For this study a driving simulator is being used which is an internationally approved method. Besides the driving simulator following tests are done: COPD Assessment Test (CAT), Hospital Anxiety and Depression Scale (HADS), Montreal Cognitive Assessment (MoCA), a clock drawing test and a continuous reaction time test (CRT). A CardioRespiratory Monitor (CRM), NOX T3TM, is used to measure if the patients have moderate to severe OSA. Furthermore, following tests are done: Epworth Sleepiness Scale (ESS).
15799153|NCT04458025|Other|Standard rehabilitation program|Standard rehabilitation will start 4 weeks after surgery according to the standard of cre
15799154|NCT04458025|Other|Early rehabilitation program|Early rehabilitation program will start 2 weeks
15799223|NCT04457349|Procedure|Therapeutic Plasma Exchange (TPE)|Treatment with Therapeutic Plasma Exchange (TPE)
15799155|NCT04458012|Diagnostic Test|Oculus Keratograph. Schirmer test. Tear fluid sample.|Objective measurements of the ocular surface using Oculus 5 keratograph. Slit lamp examination and tear fluid sample using Schirmer strips.
15799156|NCT04457999|Device|Lipiflow Thermal pulsation|Single vectored thermal pulsation treatment for dry eye
15799157|NCT04457986|Drug|Erector spina plane block (ESP)|Patient will receive ultrasound guided regional anesthesia with bupivacaine and intravenous patient controlled analgesia with tramadol
15799158|NCT04457986|Drug|Modified thoracolumbar interfacial plane block (MTI)|Patient will receive ultrasound guided regional anesthesia with bupivacaine and intravenous patient controlled analgesia with tramadol
15799159|NCT04457986|Drug|Intravenous patient controlled analgesia (IV-PCA)|Patient will receive intravenous patient controlled analgesia with tramadol
15799160|NCT04457973|Device|Active tDCS|tDCS with a constant current intensity of 2 milliampere (mA) will be applied for 20 minutes per session daily for 5 days via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and 5x7 cm saline-soaked surface sponge electrodes.
15799161|NCT04457973|Device|Sham tDCS|The electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds.
15799164|NCT04457934|Drug|Plenvu|All patients in both Groups will drink will drink 1 Liter of Plenvu and 1 Liter of water or tea in preparation for endoscopy according to endoscopy guidelines
15799165|NCT04457921|Other|deep tissue massage|Experimental group received deep tissue massage twice at 11st and 23rd hours after cesarean section.
15799166|NCT04457908|Diagnostic Test|intelligent assessment|intelligent neurological function assessment
15799167|NCT04457895|Behavioral|educational yoga program|"Daily 15-min yoga sessions at home with the Le guide du yoga and the audio-guide, during 12 weeks.
~One 90-min yoga-therapeutic education session/week (during 6 weeks) given by a physical therapist trained to postural yog (the first on site and by videoconference for the others)"
15799168|NCT04457895|Other|no intervention|no yoga session at home and no yoga -therapeutic educatuion session
15799169|NCT04457882|Behavioral|Intraperitoneal Laparoscopic Radical Prostatectomy Without Drainage Tube|No place the drainage tube after the intraperitoneal Laparoscopic Radical Prostatectomy
15799170|NCT04457882|Behavioral|Intraperitoneal Laparoscopic Radical Prostatectomy With Drainage Tube|Place the drainage tube after the intraperitoneal Laparoscopic Radical Prostatectomy
15799171|NCT04457869|Drug|F520|3mg/kg every 3 weeks
15799172|NCT04457856|Biological|TJ003234 injection|Intravenous administration, single dose (0.3-1-3-10mg/kg) or multiple dose (1-3-6mg/kg, once every week, for 8 weeks)
15799173|NCT04457843|Other|usual medical care|Prospective monitoring of clinical Outcomes and digital collected outcomes via the mobile COPD staus test app.
15799174|NCT04457830|Drug|F520|3mg/kg every 3 weeks
15799175|NCT04457817|Device|CRI management|Patients in the CRI cohort will be monitored with the goal to maintain their supine CRI values 0.9 - 0.7 (mean 0.8).
15799176|NCT04457804|Behavioral|Virtual ACT Workshop for Emotional Eating|"This is a brief online intervention using Acceptance and Commitment Therapy (ACT) technique to target and reduce emotional eating. The intervention will be modeled after Frayn and Knäuper's 1-day ACT workshop for emotional eating intervention, which was derived from Forman and colleagues' Mind Your Health Program. During the workshop, the following topics will be discussed, based on the three processes of ACT: (1) values clarification/commitment, (2) acceptance/distress tolerance, and (3) mindfulness/awareness."
15799177|NCT04457791|Behavioral|Personalized dietary advice|Via an self-developed website and algorithm, participants will receive digital personalized dietary advice to increase dietary fiber intake, aiming to reduce constipation complaints. The advice is personalized on phenotype (habitual diet, gender)
15799181|NCT04457765|Drug|Povidone-Iodine (PVP-I)|1.25% Povidone-Iodine (PVP-I) (also known as betadine) to be used pre-procedure in the operating room via irrigation into the nasal cavity to act as viricidal preparation for the procedure. 240mL of 1.25% PVP-I will be distributed evenly among the right and left nasal cavities using a a 70mL syringe.
15799182|NCT04457752|Biological|Dual Layer Amniotic Membrane (DLAM). Artacent®|"Artacent® is a double layer of dehydrated amniotic membrane. The amnion is harvested from human placenta obtained during planned Caesarean sections. Tides Medical uses a proprietary process to clean and decellularize the amniotic membrane. The amnion is then folded into a bi-layer with the stromal sides facing outward. The dual layer is dried and cut into various sizes. In the final step the DLAM is terminally sterilized.
~Atracent®, like all other placental-derived products, is FDA cleared for homologous use through the 361 pathway. It is indicated for non-healing ulcers applied to a debrided, clean and uninfected ulcers."
15799183|NCT04457739|Other|Tidal volume challenge|Increasing tidal volume from 6 to 8 mL/kg during 1 min
15799184|NCT04457739|Other|End-expiratory occlusion test|Interrupting the ventilator at end-expiration for 15-30 s and assessing the resulting changes in cardiac output
15799185|NCT04457739|Other|Trendelenburg maneuver|Patients remained in prone position with a 13° upward bed angulation throughout the study and then be positioned in a declining position at -12 ° for 1 minute
15799186|NCT04457726|Biological|SARS-CoV-2 Specific T Cells|Eligible patients will receive a single infusion of SARS-CoV-2 specific T cells intravenously.
15799188|NCT04457674|Behavioral|Cognitive Behavioral Therapy for insomnia (CBTi)|CBTi consists of six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine.
15799189|NCT04457674|Behavioral|Sleep Hygiene Education (SHE)|SHE participants receive six weekly sessions of individual therapy with a trained therapist, delivered via telemedicine.
15799190|NCT04457661|Dietary Supplement|Bacillus coagulans TCI711|Using Bacillus coagulans TCI711 for one month and implementing alcohol testing at weeks 0, 1, and 4.
15799191|NCT04457648|Device|manuka honey 16% eye drops ( Optimel )|16% manuka honey eye drops, australian FDA approved
15799192|NCT04457648|Device|systane eye drops|systane lubricant eye drops
15799193|NCT04457635|Behavioral|Psychotherapy|
15799194|NCT04457622|Other|Auditory perception tasks in healthy participants|"The participants complete auditory perception tasks while EEG, and MEG record brain signals (primary outcome measure). The tasks acquire behavioral responses with button presses (secondary outcome measure).
~All analyses are intra-subject (no analyses are between-subject)."
15799195|NCT04457609|Drug|Oseltamivir|Current standardized treatment for Covid-19
15799196|NCT04457609|Drug|Azithromycin|Current standardized treatment for Covid-19
15799197|NCT04457609|Biological|Umbilical Cord Mesenchymal Stem Cells|Adjuvant therapy on top of current standardized treatment (Oseltamivir + Azithromycin)
15799198|NCT04457596|Biological|Trastuzumab Emtansine|Given IV
15799199|NCT04457596|Drug|Placebo Administration|Given PO
15799200|NCT04457596|Drug|Tucatinib|Given PO
15799201|NCT04457596|Other|Questionnaire Administration|Ancillary studies
15799202|NCT04457596|Other|Quality-of-Life Assessment|Ancillary studies
15799203|NCT04457583|Device|Inspiratory muscle training with powerbreathe|Participants will be submitted to a linear pressure resistance (Powerbreathe) with an inspiratory load of 40% of maximal inspiratory pressure (adjusted weekly), seven days a week, session duration of 30 exercises for 12 weeks.
15799204|NCT04457570|Other|mortality|To measure the excess risk of mortality of patients with a history of cancer among patients hospitalized for a SARS-CoV-2 infection
15799205|NCT04457557|Other|Reduced concentration of local anesthetic (ropivacaine)|Reduced concentration of ropivacaine We usually use 0.5% ropivacaine in our facility. The intervention group used 0.15% ropivacaine 15 ml
15799206|NCT04457557|Other|Usual concentration of local anesthetic (ropivacaine)|0.5% ropivacaine 15ml
15799207|NCT04457531|Drug|LiuWeiLuoBi Granule|LiuWeiLuoBi Granule is a Chinese medicine made from 6 herbal medicine, including Shaji(Sea-buckthorn), Honghua (Safflower), Jinyinhua(Honeysuckle),etc.
15799208|NCT04457531|Other|Standard medical treatment|Standard medical therapy is adhered to the guidline issued by American Diabetes Association and Chinese Diabetes Society at 2017, including keeping an appropriate diet, doing some exercises, the pharmacological therapy to control the blood glucose, blood pressure and blood lipids.
15799209|NCT04457492|Other|Application of FES to the Face|Functional electrical stimulation (FES) for facial paralysis is a technique in which muscles are electrically stimulated.
15799210|NCT04457466|Drug|Nerve Growth Factor|Induction of experimental muscle soreness using intramuscular injections of Nerve Growth Factor.
15799211|NCT04457453|Other|Macintosh in sniffing position|Macintosh direct intubation in sniffing position
15799212|NCT04457453|Other|Macintosh in Trendelenburg position and Sellick position|Macintosh direct laryngoscopic intubation in Trendelenburg position and Sellick position
15799213|NCT04457453|Other|AceScope in Trendelenburg position and Sellick position|AceScope videolaryngoscopic intubation in Trendelenburg position and Sellick position
15799216|NCT04457427|Device|NeuRx Diaphragm Pacing System (DPS)|4 electrodes are implanted into the diaphragm, 2 on each side, during the tracheostomy procedure. The electrodes are connected to the NeuRx external stimulator which will be used to stimulate and monitor diaphragm activity.
15799217|NCT04457401|Dietary Supplement|Probiotic|This probiotic is commercially available and contains Bifidobacterium (3 x 10^9 colony forming units/capsule) as the active ingredient and potato starch, magnesium stearate and ascorbic acid as excipients.
15799218|NCT04457401|Dietary Supplement|Placebo|The placebo contains potato starch, magnesium stearate and ascorbic acid.
15799219|NCT04457388|Other|Tele-Yoga Therapy|Yoga practices combining with joint loosening exercises (Sukshma Vyayama), postures (Asana), breathing exercises (Pranayama), relaxation techniques and chanting ( A, U, M, and AUM { ૐ}) syllable chants meditation. Each session ended with home practice exercises given to the participants to practice everyday.
15799220|NCT04457375|Diagnostic Test|TDC|measurements
15799221|NCT04457362|Diagnostic Test|Diagnostic Arthroscopy using the Arthrex NanoScope|"A diagnostic arthroscopy will be performed with the Arthrex NanoScope.
~Structures evaluated:
~Radial styloid
~Proximal scaphoid articular cartilage
~Scaphoid fossa
~Radioscaphocapitate (RSC) ligament
~Long radiolunate (LRL) ligament
~Short radiolunate (SRL) ligament
~Scapholunate (SL) ligament
~Proximal lunate articular cartilage
~Lunate fossa
~Triangular fibrocartilage complex (TFCC) The attending performing the diagnostic arthroscopy will make an initial diagnostic assessment based on the presence/location/severity of synovitis, articular cartilage integrity, ligament injury and determine the intended treatment."
15799222|NCT04457362|Diagnostic Test|Diagnostic Arthroscopy using standard arthroscopic instruments|"A diagnostic arthroscopy will be performed with the standard arthroscopic instruments.
~Structures evaluated:
~Radial styloid
~Proximal scaphoid articular cartilage
~Scaphoid fossa
~Radioscaphocapitate (RSC) ligament
~Long radiolunate (LRL) ligament
~Short radiolunate (SRL) ligament
~Scapholunate (SL) ligament
~Proximal lunate articular cartilage
~Lunate fossa
~Triangular fibrocartilage complex (TFCC) The attending performing the diagnostic arthroscopy will make the final diagnostic assessment based on the presence/location/severity of synovitis, articular cartilage integrity, and ligament injury and determine the final treatment."
15799225|NCT04457323|Drug|Metoprolol|S-Metoprolol XR 25 mg and 50 mg Film Coated Tablets
15799226|NCT04457323|Drug|Metoprolol|Beloc® (Metoprolol) Zok 50 mg and 100 mg Controlled Release Film Tablets
15799227|NCT04457310|Drug|CVL-562 (PF-06412562) 1 mg|Each subject will complete 5 test visits each involving the administration of CVL-562 (PF-06412562) (at different doses) or placebo. Each test visit will be separated by at least 48 hours (six half-lives of CVL-562 (PF-06412562)).
15799228|NCT04457310|Drug|CVL-562 (PF-06412562) 4 mg|Each subject will complete 5 test visits each involving the administration of CVL-562 (PF-06412562) (at different doses) or placebo. Each test visit will be separated by at least 48 hours (six half-lives of CVL-562 (PF-06412562)).
15799229|NCT04457310|Drug|CVL-562 (PF-06412562) 15 mg|Each subject will complete 5 test visits each involving the administration of CVL-562 (PF-06412562) (at different doses) or placebo. Each test visit will be separated by at least 48 hours (six half-lives of CVL-562 (PF-06412562)).
15799230|NCT04457310|Drug|CVL-562 (PF-06412562) 25 mg|Each subject will complete 5 test visits each involving the administration of CVL-562 (PF-06412562) (at different doses) or placebo. Each test visit will be separated by at least 48 hours (six half-lives of CVL-562 (PF-06412562)).
15799231|NCT04457310|Other|Placebo|Each subject will complete 5 test visits each involving the administration of CVL-562 (PF-06412562) (at different doses) or placebo. Each test visit will be separated by at least 48 hours (six half-lives of CVL-562 (PF-06412562)).
15799232|NCT04457297|Drug|trifluridine and tipiracil|Trifluridine and tipiracil will be orally administered twice daily on Days 1 to 5 and Days 8 to 12. The administration will be repeated until completion of 6 courses(one course consists of 28 days) or until any discontinuation criterion is met.
15799233|NCT04457297|Drug|Placebo|Placebo will be orally administered twice daily on Days 1 to 5 and Days 8 to 12. The administration will be repeated until completion of 6 courses(one course consists of 28 days) or until any discontinuation criterion is met.
15799234|NCT04457284|Drug|Temozolomide (TMZ)|"TMZ 150 mg/m2 Day 1 - 5 Q4W PO Cycle 1
~TMZ 200 mg/m2 Day 1 - 5 Q4W PO Cycle 2 +"
15799235|NCT04457284|Drug|Cisplatin|Cisplatin 40 mg/m2 Q2W IV infusion Cycle 1 +
15799236|NCT04457284|Drug|Nivolumab|Nivolumab 480 mg Q4W IV infusion Cycle 1 +
15799237|NCT04457271|Behavioral|Goal Management Training (GMT)|GMT is a structured, short-term cognitive remediation program with an emphasis on mindfulness and practice in planning and completion of goal-oriented behaviours. The main objective of GMT is to help participants regain executive control in order to better define goals and monitor performance in achieving them. Sessions include instructional material, interactive tasks, discussion of patients' real-life deficits, and homework assignments. Mindfulness meditation is also incorporated for the purpose of developing the skill of bringing one's mind to the present to monitor ongoing behaviour, goal states, and the relationship between them, and for the development of attentional control. The program incorporates real-life examples to illustrate goal attainment failures and successes, as well as in-session practice of complex tasks that mimic real-life tasks - typically a challenge for individuals with executive function deficits (e.g., planning and set-shifting tasks).
15799238|NCT04457258|Procedure|Computed Tomography|Undergo PET/CT
15799239|NCT04457258|Drug|Gallium Ga 68 FAPi-46|Given IV
15799240|NCT04457258|Procedure|Positron Emission Tomography|Undergo PET/CT
15799241|NCT04457245|Procedure|Computed Tomography|Undergo whole body PET/CT
15799242|NCT04457245|Other|Fluorine F 18 DCFPyL|Given IV
15799243|NCT04457245|Procedure|Positron Emission Tomography|Undergo whole body PET/CT
15799244|NCT04457245|Radiation|Radiation Therapy|Undergo standard of care definitive radiation therapy
15799245|NCT04457232|Procedure|Computed Tomography|Undergo PET/CT imaging
15799246|NCT04457232|Other|Gallium Ga 68 FAPi-46|Given IV
15799247|NCT04457232|Procedure|Positron Emission Tomography|Undergo PET/CT imaging
15799248|NCT04457219|Device|Haemostatic Dressing|A Hemostatic Dressing is applied at the radial access site, following a transradial angiographic procedure. This is a mineral-based dressing with a hydrophilic polymer that works independently of the clotting cascade to seal the site, by accelerating topical hemostasis.
15799249|NCT04457219|Device|Conventional Dressing|A Conventional Absorbent Dressing is applied at the radial access site, following the transradial angiographic procedure.
15799250|NCT04457219|Device|120 Minutes External Compression|A radial compression device is applied at the radial access site to achieve patent hemostasis. The device remains in situ for 2 hours. Prolonged time of compression may be required.
15799251|NCT04457219|Device|60 Minutes External Compression|A radial compression device is applied at the radial access site to achieve patent hemostasis. The device remains in situ for 1 hour. Prolonged time of compression may be required.
15799252|NCT04457206|Behavioral|SCI Group and one-on-one services through student led occupational therapy clinic|The Collaborative Community Clinic (CCC) students collaborate with Dr. Walker to conduct the spinal cord injury/disease (SCI/D) Health and Participation Program, which consists of a combination of groups and one-on-one OT sessions serving persons with spinal cord injury and disease who are un- or under-insured. The program includes a pre-assessment session, four groups, optional individual sessions and a post-survey. Group topics include bowel/bladder management, community mobility, advocacy, transportation, promoting intimacy, adaptive parenting and finding resources. Students are involved in recruiting participants, co-leading group sessions, treatment planning and implementation for individual sessions, and development of topic-specific materials.
15799253|NCT04457193|Device|TIF|Transoral Incisionless Fundoplication (TIF) is an endoscopic procedure that mechanically creates fundoplication similar to traditional operative Nissen fundoplication. The role of TIF in patients with BE whom underwent successful endoscopic ablation has not been fully investigated.
15799254|NCT04457180|Drug|Apatinib Mesylate|Apatinib will be administered daily from on D5 through D16
15799255|NCT04457180|Drug|Repaglinide|Repaglinide will be administered daily on D1 and D12
15799256|NCT04457180|Drug|Bupropion|Bupropion will be administered daily on D2 and D13
15799257|NCT04457167|Device|Robot-assisted|robot-assisted surgery
15799258|NCT04457167|Procedure|Not robot-assisted surgery|Not robot-assisted surgery
15799259|NCT04457154|Device|Inspire Upper Airway Stimulation System|Implant of the Inspire Upper Airway Stimulation System
15799330|NCT04456634|Other|20 mg/120 mg artemether-lumefantrine (AL) + Placebo|Placebo administered 2 hours after AL administration, twice daily (b.i.d) for 3 consecutive days (6 doses in total).
15799260|NCT04457141|Combination Product|Effect of pelvic floor for the use of minimalist shoes versus shod in woman.|Measure the activity of the pelvic floor and others muscles with EMG during treadmill running with different speeds and different shoes: minimalist and shod.
15799261|NCT04457128|Behavioral|Just-in-Time Adaptive Intervention|Randomized factorial design
15799262|NCT04457115|Procedure|Thoracic paravertebral block|Thoracic paravertebral block performed at T2-T3 and T4-T5 levels with administration of Ropivacaine 0.7% 8 ml for each level
15799263|NCT04457115|Procedure|Erector spinae plane Block|Erector spinae plane block performed at T2 and T5 levels with administration of Ropivacaine 0.5% 12 ml for each level
15799264|NCT04457102|Device|MANIV|mechanical ventilator (Bellavista 1000, IMTmedical) will be used on Varian® Halcyon LINAC and Infinity Elekta® linac
15799265|NCT04457102|Other|Spontaneous DIBH|performed on Varian® Halcyon LINAC and Infinity Elekta® linac
15799266|NCT04457089|Drug|Simvastatin 40mg|Simvastatin 40mg by mouth nightly for approximately 6 months during treatment with carboplatin and liposomal doxorubicin
15799267|NCT04457076|Drug|LevoCept|Levonorgestrel-Releasing Intrauterine System
15799268|NCT04457063|Procedure|PKP|"The horizontal axis was marked with a pointed marker at the slit lamp immediately before surgery.
~TICL loading into the STAAR injector cartridge
~Temporal clear corneal 3 mm incision & 2-side ports then viscoelastic injection into the AC
~Implantation of the TICL using the injector, then rotation according to the implantation diagram guided with Mendez protractor, and lastly placement of the haptics under the iris.
~Pupil constriction with A.Ch.
~Washing the viscoelastic &Wound hydration.
~Topical antibiotic steroids (Vigamox and Tobradex) 4 times /day for 3weeks"
15799269|NCT04457050|Drug|Sofosbuvir 400 milligram|single daily dose of 400 milligrams
15799270|NCT04457050|Drug|Daclatasvir 60 milligram|single daily dose of 60 milligrams for 12 weeks
15799271|NCT04457050|Drug|Ribavirin 400 milligram|weight based dose, 1200 mg for weight > 75 kilogram, and 1000 milligram if weight < 75 kilograms for 12 weeks
15799272|NCT04457050|Drug|Ledipasvir 90milligram/Sofosbuvir 400 milligram Tab|single daily dose for 12 weeks
15799273|NCT04457037|Biological|Autologous adipose-derived mesenchymal stem cells|Autologous adipose-derived mesenchymal stem cells
15799274|NCT04457024|Other|classification statistics|Without any intervention
15799275|NCT04457011|Drug|High dose Susu Xiao'er Zhike Granules 1 bag|High dose Susu Xiao'er Zhike Granules 1 bag(9g granule per bag,contains 20.25g crude herbs), twice a day (7-9a.m. and 5-7p.m.) for five days
15799276|NCT04457011|Drug|Middle dose Susu Xiao'er Zhike Granules 1 bag|Middle dose Susu Xiao'er Zhike Granules 1 bag(9g granule per bag,contains 10.13g crude herbs), twice a day (7-9a.m. and 5-7p.m.) for five days
15799277|NCT04457011|Drug|Extremely-low dose Susu Xiao'er Zhike Granules 1 bag|Extremely-low dose Susu Xiao'er Zhike Granules 1 bag(9g granule per bag,contains 0.51g crude herbs), twice a day (7-9a.m. and 5-7p.m.) for five days
15799278|NCT04456998|Drug|GB002 (seralutinib)|Capsule containing GB002 (seralutinib)
15799279|NCT04456998|Drug|Placebo|Matching capsule containing placebo
15799280|NCT04456998|Device|Generic Dry Powder Inhaler|Generic dry powder inhaler for GB002 (seralutinib) or placebo delivery
15799281|NCT04456985|Dietary Supplement|Folic acid and vitamin B12|Take folic acid and VitB12 for 3 consecutive days before surgery
15799282|NCT04456985|Dietary Supplement|brown sugar aqueous|take 20 ml of brown sugar aqueous solution with the same concentration as the intervention group 3 days before the operation
15799283|NCT04456972|Diagnostic Test|One arm only|Samples of plasma to analyze ctDNA
15799284|NCT04456959|Drug|Inotuzumab Ozogamicin|Inotuzumab ozogamicin is an antibody-drug conjugate (ADC) composed of a recombinant humanised IgG4 kappa CD22-directed monoclonal antibody (produced in Chinese hamster ovary cells by recombinant DNA technology) that is covalently linked to N-acetyl-gamma-calicheamicin dimethylhydrazide.
15799285|NCT04456946|Device|Low Level Laser Therapy|Low Level Laser Therapy
15799286|NCT04456946|Device|Occlusal Splint Treatment|Occlusal Splint Treatment
15799287|NCT04456933|Procedure|Extracorporeal left hemicolectomy anastomosis|"Standard surgical technique protocolized in the unit for laparoscopic surgery of the left colon, sigma and high rectum for the last 10 years.
~After sectioning the distal colon using a mechanical stapler (60mm blue load), a pfannestiel-type suprapubic accessory incision is made, with externalization of the tumor under wound protection with a ringed retraction device. Both the resection of the left mesocolon or mesosigma, and the placement of the head of the circular stapler are performed extracorporeally by proximal section of the colon with a pursetring® self-suturing device, removal of the piece, placement of the head, and reconnection of the pneumoperitoneum for colorectal anastomosis with Circular Stapler Curved B. Braun®"
15799288|NCT04456933|Procedure|Intracorporeal left hemicolectomy anastomosis|"o Intracorporeal resection of the left mesocolon
~The mesocolon resection will be performed totally intracorporeally to its proximal end. The distal colon section will be performed using a mechanical stapler (blue charge 60mm)
~o Preparation of Intracorporeal Anastomosis
~The anastomosis will be performed in a mechanical end-to-end manner using a Circular Stapler Curved B. Braun®.
~The Insertion of the stapler head into the proximal colon will be placed intracorporeally with an incision distal to the staple section. Once the head has been exteriorized at the terminal end of the proximal colon, a circular purse-type suture with prolene 2.0 will be made.
~Once the mechanical colorectal anastomosis is performed, 4-6 stitches of anastomotic reinforcement with silk 2.0 will be placed.
~The extraction of the piece will be carried out with endobag protection and with an accessory incision (pfannestiel or other location depending on the patient)"
15799289|NCT04456920|Other|phone consultation|At D1, D2 and D3, patients in the experimental group 1 will receive a call from a neuro-psychologist during which pain, anxiety and esthetical biopsy impact will be assessed using numeric or visual analog scales during a semi-direct interview. During this call, any adverse events related to the breast biopsy will also be noted, as well as the amount, nature and dose of analgesics, anxiolytics, anti-depressants, anti-inflammatory and hypnotics taken linked to the biopsy. If detected, pain or significative distress would be specifically managed.
15799331|NCT04456621|Radiation|PBT|Proton beam radiotherapy 70 gray relative biological equivalent (GyRBE)/10 fractions (Fx) or 60 GyRBE/5 Fx
15799332|NCT04456608|Drug|Aspirin|Low and high n-3 PUFA participants will receive 81-mg aspirin once a day, for 6 days.
15799333|NCT04456595|Biological|Adsorbed COVID-19 (inactivated) Vaccine|Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac
15799290|NCT04456920|Other|e-PRO self-completed via connected objects (tablet/phone)|Patients in the experimental group 2 will be asked by SMS or notification to connect to the application in order to complete online the numeric and visual anog scales of pain, anxiety and esthetical impact. Any adverse events related to the breast biopsy will also be noted online, as well as the amount, nature and dose of analgesics, anxiolytics, anti-depressants, anti-inflammatory and hypnotics taken for the biopsy. If detected, pain or significative distress would be specifically managed
15799291|NCT04456920|Other|phone consultation|At D4 post biopsy, all patients (of the 3 groups) will receive a phone call from a neuro-psychologist to assess pain, anxiety and esthetical impact, using numeric scales, and to collect adverse events. If detected, pain or significative distress would be specifically managed.
15799292|NCT04456920|Other|visit|And at D10 (+/- 2 days), all patients will physically come to the Cancer center in the consultation of biopsy results announcement. At the beginning of this consultation, pain, anxiety and esthetical impact will be assessed using numeric scales. . The adverse events related to the breast biopsy will be collected as well as the amount, nature and dose of analgesics, anxiolytics, anti-depressants, anti-inflammatory and hypnotics taken for the biopsy and its findings. Insomnia will be evaluated by the Insomnia Severity Index. If detected, pain or significative distress would be managed as usually in the center.
15799293|NCT04456907|Other|platelet rich plasma|Autologous platelet-rich plasma (PRP) was prepared using the RegenKit THT system (RegenLab SA, Le Mont-sur-Lausanne, Switzerland) following the manufacturer's instructions. Medical technicians, who had been well-trained by the manufacturer, were responsible for the process of PRP preparation. For each patient, 8-10 mL of venous blood was drawn and collected to the commercial RegnLab THT tube, which contained 1 mL sodium citrate. After single centrifugation at 3400 revolutions per minute (rpm) for 8 minutes, 4-5 mL of PRP was yielded with leukocytes maintained at physiological levels and red blood cells depleted. Then, the blood components were separated, with the platelet pellet resting on the separating gel. PRP for later application was obtained by re-suspending the platelet pellet in the plasma supernatant by gently inverting the unopened RegenKit THT tube 5 to 10 times.
15799294|NCT04456907|Other|saline injection|saline injection
15799295|NCT04456881|Other|Patients with patellar dislocation undergo patellar femoral medial reconstruction|Arthroscopic double-beam anatomical reconstruction of medial patellofemoral ligament
15799296|NCT04456868|Behavioral|Electroencephalogram|Electroencephalogram will be done for P300 wave assessment
15799297|NCT04456868|Behavioral|walking test|8-Meter walking test will be done for gait parameter assessment
15799298|NCT04456868|Behavioral|Quality of life questionnaire|Starkstein Apathy Scale, DSM-5 criteria, Montgomery-Åsberg Depression Rating Scale, Perseverative Thinking Questionnaire, classification of Hoehn & Yahr
15799299|NCT04456868|Procedure|Position emission tomography|Position emission tomography will be done for
15799300|NCT04456855|Procedure|Locoregional surgery|Patients had pathologically confirmed operable stage IV breast infiltrating carcinoma at initial presentation, and had locoregional surgery for the breast cancer.
15799301|NCT04456842|Other|Patient Registry Data|To set data on demographic characteristics,documenting antithrombotic therapy, describe the INR control level of VKA users, discontinuation rates and clinical outcomes, such as stroke, hemorrhage and death.
15799302|NCT04456829|Dietary Supplement|Resveratrol drink|Subjects will consume a bottle of resveratrol drink for two months.
15799303|NCT04456829|Dietary Supplement|Placebo drink|Subjects will consume a bottle of placebo drink for two months.
15799304|NCT04456816|Drug|100 mg AP1189|100 mg AP1189 powder in bottle. The dose of 100 mg AP1189 is selected as the starting dose, though with the opportunity to adjust the dose, based on a blinded evaluation of the pharmacokinetics results following dosing of the first 9 subjects.
15799305|NCT04456816|Drug|Placebo|Placebo powder in bottle
15799306|NCT04456803|Drug|Ferric citrate tablet|250mg/tablet, manufactured by Sinomune Pharmaceutical
15799307|NCT04456803|Drug|Sevelamer carbonate tablet|800 mg/tablet, manufactured by Genzyme Ireland Limited
15799308|NCT04456777|Drug|Vortioxetine|vortioxetine will be administreted for 3 months
15799309|NCT04456764|Behavioral|SaFTiE|A multi-modal fatigue risk management program.
15799310|NCT04456764|Behavioral|Attention Placebo Control|A multi-modal teamwork assessment program.
15799311|NCT04456751|Other|Redo op|Patients with a redo operation
15799312|NCT04456738|Behavioral|Parent Training|16 weeks of of parent training led by a trained group facilitator
15799313|NCT04456725|Behavioral|Intensive management|The intervention group will be assigned to a partnership of one nurse practitioner and one medical assistant who will manage them intensively, with the support of the study team.
15799314|NCT04456725|Behavioral|Control|Usual care
15799315|NCT04456712|Drug|Ciprofloxacin 400 MG/200 ML Intravenous Solution|antibiotic
15799316|NCT04456712|Drug|Levofloxacin 750 MG|antibiotic
15799317|NCT04456699|Drug|Olaparib|300 mg BID, oral until progressive disease or end of study
15799318|NCT04456699|Drug|5-FU|2400 mg/m2 over 46 to 48 hours Q2W IV infusion until disease progression or end of study
15799319|NCT04456699|Drug|Bevacizumab|5 mg/kg Q2W IV infusion until progressive disease or end of study
15799320|NCT04456686|Drug|LY3016859|LY3016859 given IV.
15799321|NCT04456686|Drug|Placebo|Placebo given IV.
15799327|NCT04456660|Procedure|sFlt-1 measurement & placental Doppler|Measurement of sFlt-1 levels in maternal blood as a potential inflammation indicator. Investigating the levels of placental circulation.
15799328|NCT04456647|Other|Parenteral nutrition|Parenteral nutrition treatment in palliative care
15799329|NCT04456634|Drug|20 mg/120 mg artemether-lumefantrine (AL) + 20 mg ruxolitinib phosphate (Rux)|Rux administered 2 hours after AL administration, twice daily (b.i.d) for 3 consecutive days (6 doses in total).
15799334|NCT04456595|Biological|Placebo|Placebo of Adsorbed COVID-19 (inactivated) Vaccine manufactured by Sinovac
15799335|NCT04456582|Procedure|Shear wave elastography|The elastographic technique by ultrasound (USE), shear waves or shear wave elastography (SWE), quantitatively evaluates tissue stiffness by mapping the propagation of acoustic waves (shear waves), in a non-invasive manner and without emission of ionizing radiation. Their speeds are tracked by the ultrasound equipment after tissue deformation occurs, generated by pulses of acoustic radiation (ARFI) of the transducer itself. Assuming the correlation between tissue stiffness and increased acoustic propagation speeds, it is possible to describe mathematically the elasticity of tissues by measuring specific acoustic waves.
15799336|NCT04456569|Device|Geniculate Artery Embolization|All patients within the embolization group will undergo unilateral angiography and embolization of the appropriate treatment limb geniculate arteries. For patients with bilateral disease the more clinically symptomatic side will be chosen as the treatment/control knee.
15799337|NCT04456543|Procedure|pressure monitoring|garment pressures were monitored using the portable pressure measuring device and the compression garment was adjusted so that the pressure was maintained at the therapeutic range of 15 - 25 mmHg.
15799338|NCT04456530|Drug|Aveed 750 MG in 3 ML IM Injection|Participants in the Testosterone Group will receive two IM Aveed injections 1 month apart.
15799339|NCT04456530|Other|Normal Saline 3 ML IM Injection|Participants in the Control Group will receive two IM normal saline injections 1 month apart.
15799340|NCT04456517|Drug|Ranolazine|500 mg tablet
15799341|NCT04456517|Drug|Placebo|Ranolazine-matched placebo tablet
15799342|NCT04456504|Biological|Recombinant hepatitis B vaccine with CpG adjuvant|Each participant will receive two doses of hepB-CpG separated by one month and blood draw to measure antibody to the hepatitis B surface antigen prior to dose 2 and one month after dose 2.
15799343|NCT04456478|Procedure|pH at 7.38 ± 0.02|In the 3 centers of the study, IVF-ICSI will be performed according to the usual procedure: ovarian stimulation, oocyte retrieval, sperm microinjection by ICSI, embryo culture in Global® Total HSA medium, embryo selection and transfer at day 3. The day of the oocyte puncture, the embryologist will proceed to the 1: 1 randomization: culture of the embryos in a medium with a pH at 7.38 ± 0.02. We have chosen to study specifically the early stages of fertilization and embryo development (until day 3), stages for which extracellular pH control is more critical because the intracellular pH regulatory mechanisms are somewhat limited and could be exceeded.
15799344|NCT04456478|Procedure|pH at 7.22 ± 0.02|In the 3 centers of the study, IVF-ICSI will be performed according to the usual procedure: ovarian stimulation, oocyte retrieval, sperm microinjection by ICSI, embryo culture in Global® Total HSA medium, embryo selection and transfer at day 3. The day of the oocyte puncture, the embryologist will proceed to the 1: 1 randomization: culture of the embryos in a medium with a pH at 7.22 ± 0.02. We have chosen to study specifically the early stages of fertilization and embryo development (until day 3), stages for which extracellular pH control is more critical because the intracellular pH regulatory mechanisms are somewhat limited and could be exceeded.
15799345|NCT04456465|Other|Pain diabetic peripheral neuropathy|Neuropathic pain is the focus of current clinical research, clinical identification, and treatment. It is unique from nociceptive pain and requires evaluation of the relevance and utility of common pain measures created for other painful conditions.
15799346|NCT04456452|Biological|Ampion|Ampion, administered by intravenous infusion
15799347|NCT04456452|Other|Standard of Care|Standard of Care
15799348|NCT04456439|Biological|Remestemcel-L|Participants may receive up to 2 infusions of 2 x 10^6 remestemcel-L within a 5-day period.
15799349|NCT04456439|Drug|Hydrocortisone|Participants who are not currently taking a corticosteroid will receive hydrocortisone, 0.5-1 milligram per kilogram (mg/kg), up to 50 mg IV, at least 30 minutes prior to the infusion of remestemcel-L.
15799350|NCT04456439|Drug|Diphenhydramine|Participants will receive diphenhydramine, 0.5-1 mg/kg, up to 50 mg IV, at least 30 minutes prior to the infusion of remestemcel-L.
15799351|NCT04456413|Biological|Convalescent Plasma|Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection
15799352|NCT04456413|Other|Best Supportive Care|Patients will receive best supportive care. Patients randomized to this arm may receive plasma should they require hospitalization for progression of COVID-19 disease.
15799353|NCT04456400|Diagnostic Test|Multispectral Optoacoustic Tomography (MSOT)|cMSOT-2 system is indicated for measurement of the Multispectral Optoacoustic Tomography (MSOT) values in the bowel wall of patients with an established diagnosis of inflammatory bowel disease (IBD), specifically Crohn's Disease (CD) and Ulcerative Colitis (UC). The MSOT values provided may be used as an aid to the assessment of inflammatory disease activity in the bowel wall.
15799354|NCT04456387|Drug|Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection|Participants received on-demand treatment, doses range from 30 IU/kg to 50 IU/kg, or doses divided on the discretion of the Investigator.
15799355|NCT04456387|Drug|Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection|Participants received prophylaxis treatment at 50 IU/kg every three days.
15799356|NCT04456374|Other|Performance testing|Soccer-specific performance will be evaluated by measuring flexibility, jumping ability, maximum speed, repeated spring ability, agility and endurance.
15799357|NCT04456361|Biological|Mesenchymal Stem Cells derived from Wharton Jelly of Umbilical cords|Mesenchymal Stem Cells as a single-dose therapy via IV infusion at a dose of 1 X 10 8 cells.
15799358|NCT04456348|Other|there is no intervention|There is no intervention
15799359|NCT04456335|Genetic|Collection of supragingival plaque from caries free children|Supragingival plaque samples were collected from posterior molar teeth
15799360|NCT04456322|Drug|RT plus Nimotuzumab|Nimotuzumab (200mg, once a week during radiotherapy, a total of 7 weeks)
15799361|NCT04456322|Drug|RT plus Cisplatin|concurrent cisplatin (100mg/m2, every three weeks,D1,D22,D43 of intensity modulated radiotherapy )
15799362|NCT04456309|Other|No intervention,|pure observational study
15799364|NCT04456283|Behavioral|Survival|5 year survival after Chemoradiation theraphy for Rectal Cancer
15799365|NCT04456257|Device|fractional picosecond 1,064 nm laser|The parameter of laser was 8-mm spot size, 0.6 mJ/cm2, 750 ps, 10 Hz, 2 passes. The treatment was done in every 4 weeks for 4 sessions.
15799366|NCT04456244|Other|Evaluation of the static posture|Photographing from the back, front and side with ADIBAS posturography in standing position
15799367|NCT04456231|Drug|Plenvu|Patients will receive Plenvu for preparation of endoscopy
15799368|NCT04456218|Device|NCKU-scope-01 (a custom-made biliary endoscope system)|The NCKU-scope-01 is a custom-made endoscope system for this study and it will be applied to help biliary disorders diagnosis
15799369|NCT04456192|Behavioral|Indoor Cycling Interval Exercise Training|"The 3-month intervention consisted of a physical exercise program involving three indoor cycling sessions per week, with a total of 36 training sessions. Subjects exercised on cycle ergometers Schwinn® Evolution® (Schwinn Bicycle Company, Boulder, Colorado, USA). Each session lasted approximately 55 minutes. Training sessions consisted of a 5-min low-intensity warm-up (cycling at 50-65% of maximum heart rate (HRmax)), 40 min of main training at an intensity of 65-95% of HRmax, 5 min of non-weight-bearing cycling, finishing with 5 min of low-intensity cool-down stretching and breathing exercises.
~Main part of the training was interval. Each exercise session consisted of 3 to 4 high intensity intervals with intensity exceeding 80% of HRmax, often reaching anaerobic threshold. High intensity intervals lasted approximately 4-minutes and were interspersed by recovery periods at 65-80% of HRmax."
15799370|NCT04456179|Device|GE Datex-Ohmeda Oxy-F Finger Clip Pulse Oximeter Sensor|PPG based, fingertip mounted sensor, that measures the oxygen level (oxygen saturation) of the blood and generates a waveform
15799371|NCT04456179|Device|Arrow® arterial catheterization kit (Teleflex)|Invasive monitoring of blood pressure via catheterization of the radial artery, displaying a continuous pressure waveform
15799372|NCT04456166|Dietary Supplement|noNPO|"Patients with diabetes mellitus type 2 who are planned to receive a carbohydrate beverage (400 ml (12.8% carbohydrates, 50 kcal/100 ml; Nucare NONPO Ⓡ , Daesang Wellife, Korea) before the operation and up to 2 hours before the induction of anesthesia outside this clinical study setting will be asked to be enrolled into the study.
~Before induction of general anesthesia, all patients were evaluated the gastric volume under ultrasonography."
15799373|NCT04456153|Drug|Experimental Group|Continued standard of care therapy together with an oral dose of 1500 mg atovaquone twice daily (administered with a meal or snack) for up to 10 days
15799374|NCT04456153|Drug|Placebo Group|Continued standard of care therapy together with matching placebo
15799375|NCT04456140|Procedure|Biospecimen Collection|Undergo collection of blood samples
15799376|NCT04456140|Other|Genetic Counseling|Watch pre-test genetic counseling video
15799377|NCT04456140|Other|Genetic Testing|Undergo genetic testing
15799378|NCT04456140|Other|Survey Administration|Ancillary studies
15799379|NCT04456127|Procedure|Fractional CO2 Laser|The UltraPulse® fractional ablative CO2 Laser will be employed with the DeepFX™ hand piece. Number of passes and laser settings, including fluency, density, spot size, will be chosen during the time of treatment as determined by the operating surgeon.
15799380|NCT04456114|Device|Acid etched brackets|The brackets will be bonded to the teeth with composite on the same patient in a split mouth design and observed for bracket debonding for 18 months
15799381|NCT04456114|Device|Sandblasted brackets|The brackets will be bonded to the teeth with composite on the same patient in a split mouth design and observed for bracket debonding for 18 months
15799382|NCT04456088|Combination Product|150 ppm Nitric Oxide delivered through LungFit Delivery System|Nitric Oxide delivered via LungFit system. Patients will receive inhalations of 150 ppm for 40 minutes 4 time per day plus standard supportive care.
15799383|NCT04456088|Combination Product|80 ppm Nitric Oxide delivered through LungFit Delivery System|Nitric Oxide delivered via LungFit system. Patients will receive inhalations of 80 ppm for 40 minutes 4 time per day plus standard supportive care.
15799384|NCT04456062|Other|Caring Contacts|Caring Contacts are brief email communications sent to the patient post-discharge. They convey messages of hope, support, promote a sense of belonging, and provide information on resources for care. They are not written uniquely for each patient but are purposefully crafted to intervene on those specific vulnerabilities that form the core of many patients' experiences with intense emotional distress and suicidal thoughts.
15799385|NCT04456049|Drug|Enzalutamide|40 mg oral tablets once daily for a maximum of 28 days.
15799387|NCT04456010|Other|Questionnaire|Eligible patients will be selected from our electronical database and invited via email to participate.
15799388|NCT04455984|Other|Date collection|Retrospective data analysis
15799389|NCT04455971|Behavioral|Orgasmic Meditation|Orgasmic Meditation (OM) is a form of meditation that increases bodily awareness during structured, partnered female genital stimulation over a 15-minute period.
15799390|NCT04455958|Drug|Lopinavir/Ritonavir|Given PO
15799391|NCT04455958|Drug|Placebo Administration|Given PO
15799392|NCT04455958|Other|Questionnaire Administration|Ancillary studies
15799393|NCT04455945|Procedure|Open Rectal cancer surgery|Open sphincter preserving surgery for rectal cancer
15799394|NCT04455945|Procedure|Laparoscopic Rectal cancer surgery|Laparoscopic sphincter preserving surgery for rectal cancer
15799395|NCT04455932|Diagnostic Test|Abbreviated non-contrast MRI of the liver|every 6 months
15799396|NCT04455932|Diagnostic Test|Ultrasound surveillance|every 6 months
15799397|NCT04455932|Diagnostic Test|Multiphase contrast-enhanced liver MRI|screening
15799398|NCT04455919|Other|Wait-list group|The wait-list group benefit from a 8-week yoga program after the interventional group
15799399|NCT04455919|Other|Yoga group|During 8 weeks, the intervention group attended weekly yoga sessions and had to practice poses at home
15799464|NCT04455386|Diagnostic Test|Stress radiography,Anterior drawer test,Stress ultrasound,Computed tomography, Magnetic resonance imaging,Arthroscopy|All patients suspected chronic ankle instability, will perform an anterior drawer test, stress ultrasound, computed tomography, magnetic resonance imaging of ankle. Patients with chronic ankle instability will be recommended to perform an arthroscopic repair if non-operative treatment failed.
15799465|NCT04455373|Procedure|pediatric vascular bypass grafting|pediatric vascular bypass grafting
15799594|NCT04454307|Other|Standard care delivered in the isolation hospitals.|Oxygen ventilation.
15799400|NCT04455893|Other|Stratified Transplant Survival|The transplant survival rate in the table of outcome statistics is stratified into two groups: (i) patients who received excellent donor organs and (ii) patients who received less than optimal donor organs. Stratified transplant survival is computed from survival rates of transplant patients who received each quality category of organ. excellent transplant survival = [number of patients surviving after transplant with excellent organ]/[number of patients for whom excellent organ was accepted for transplant] marginal transplant survival = [number of patients surviving after transplant with marginal organ]/[number of patients for whom marginal organ was accepted for transplant]
15799401|NCT04455880|Other|SWE is a novel noninvasive dynamic ultrasound technique which refers to measurement for quantitative analysis of tissue elasticity|SWE is a novel noninvasive dynamic ultrasound technique which refers to measurement for quantitative analysis of tissue elasticity. The stiffer the tissue, the higher shear wave velocity is measured. Elastographic examinations were performed by physicians using Samsung HS70A ultrasound system with a Samsung CA1-7A convex transducer and S-Shear wave technique. During the examination, patients were lying in supine position, breathing levels kept steady to prevent noise and artifacts and minimum pressure were applied on the transducer to eliminate misleading tissue compression. A region of interest (ROI) box of 10 × 10 mm was positioned on placenta and six measurements were obtained from central and peripheral zones of placenta while avoiding vascular structures
15799402|NCT04455867|Behavioral|Diabetes Exercise and Healthy Lifestyle Program|The program combines exercise, education and healthy lifestyle behaviour changes. Participants will begin the program with a cardiopulmonary exercise assessment. Then the team will create a personalized program of exercise based on functional abilities and personal goals. Participants will attend 1 supervised exercise class a week, which includes a warm-up and stretching routine, aerobic exercise (walking, stationary cycling or elliptical machine), resistance training and an educational session. This program also offers peer-to-peer support and encourages participants to carry out their own exercise program at home 4 more times per week and to keep a weekly exercise diary to help them with their progress.
15799403|NCT04455867|Other|Outpatient care|Participants receive usual care from outpatient services, which may include Endocrinology, Family Medicine, or Diabetes Education
15799404|NCT04455841|Drug|INCB000928|INCB000928 Dose Escalation
15799405|NCT04455841|Drug|ruxolitinib|INCB000928 +ruxolitinib Dose Expansion
15799406|NCT04455828|Device|WHOOP strap 3.0|WHOOP strap 3.0, a photodiode-based device that tracks heart rate, respiratory rate, sleep, and heart rate variability.
15799407|NCT04455815|Drug|Camostat|Patient to receive treatment with camostat tablets, 200mg four times daily (qds) for 14 days.
15799408|NCT04455802|Drug|Buprenorphine or Placebo|The double blind, double dummy design necessitates that both drugs be on an identical schedule. The 4-hour dosing allows for this pairing. If a patient is randomized to the buprenorphine arm, medication administration will follow an every 8-hour dosing but medication will be substituted with placebo during the intermediary time point.
15799409|NCT04455802|Drug|Morphine or Placebo|If a patient is randomized to the morphine arm, morphine will be given every 4 hours. Placebo will also be given at the same frequency as a faux drug.
15799410|NCT04455789|Procedure|routine lung protective, conventional mechanical ventilation|routine lung protective, conventional mechanical ventilation with stabil PEEP
15799411|NCT04455776|Drug|Propofol|Sedation by propofol
15799412|NCT04455763|Procedure|SVF|Adipose-derived stromal vascular fraction
15799413|NCT04455763|Other|Splint|Thumb brace (Actimove® Rhizo Forte)
15799422|NCT04455737|Other|injection of indigo carmine|Ex vivo intra-arterial injection of 20 ml indigo carmine solution (10mL, 0.4% indigo carmine with 10mL, 0.9% saline solution) in the transanal total mesorectal excision specimen via the inferior mesenteric artery.
15799423|NCT04455724|Device|Negative pressure incisional wound therapy|A vacuum-style dressing system that is sealed in place over a surgical wound, applying constant negative pressure to the healing tissues.
15799424|NCT04455724|Device|Standard sterile dressing|A standard, sterile island dressing
15799425|NCT04455711|Drug|Lidocaine Iv|Bolus dose of 1.5 mg/kg lidocaine was injected immediate after operation.
15799426|NCT04455711|Drug|Remifentanil|Continuous infusion of remifentanil 1.5 ng/ml until extubation
15799427|NCT04455698|Behavioral|Remote Telegenetic Counseling by Phone|Participants will receive standard of care pre-test and disclosure genetic counseling with a genetic counselor by Telephone.
15799428|NCT04455698|Behavioral|Remote Telegenetic Counseling by Videoconferencing|Participants will receive standard of care pre-test and disclosure genetic counseling with a genetic counselor using Videoconferencing Technology.
15799429|NCT04455698|Behavioral|Usual Care Arm|Participants in the usual care arm will receive usual care services depending on which referral method they choose and if they initiate services. After a 6 month status survey, if they have not had genetic services through usual care they will be offered services and re-randomized to ARM A/ARM B.
15799430|NCT04455685|Other|anonymised data collection|The population of the present study corresponds to a sample of previous market research. Data from participants from the five main regions of Brazil (North, Northeast, Midwest, South, Southeast) will be selected at random and according to the sample size calculation.
15799431|NCT04455672|Device|splints|"Scaning of the maxillary and mandibular cast in the centric relation.
~The CAD/ CAM splints will be designed using Exocad s.
~The design will include all maxillary teeth and the occlusal surfaces will be flat and smooth.
~The difference in design between the ARS and the stabilization splint, is that the ARS will have an anterior ramp to allow for posterior disocclusion of posterior teeth, while the stabilization splint will not have such a pronounced anterior ramp.
~Both splints will be printed using Dent2 3D printer and then cured using Dentcure.
~All patient will be asked to wear their spints during sleeping only.
~In each group, patient will be recalled after 1week,2 weeks 1,2and 3monthes then change for the other splint for another 3 months ."
15799432|NCT04455659|Device|Trans-cutaneous Electrical Nerve Stimulation|TENS that was applied once daily, three times per week for 8 weeks. Each treatment session was conducted for 20 minutes, two electrodes were positioned over the perineal area between anus and scrotum on the Centrum tendineum, while the other two electrodes were applied under the buttocks medially at the level of the ischial spines (medial to the ischial spines bilaterally) with the patient in comfortable supine hook-lying position with abducted hips. to prevent burn beneath the electrodes, the surface area of the electrode should be equal to or greater than 4 cm2 to minimize the heat production. In addition, to decrease the current density between electrodes, the inter-electrode distance was less than the cross sectional area of the electrode
15799433|NCT04455659|Procedure|Conventional physical therapy exercise|physical therapy program for 30 minutes, and 3 times per week for 8 weeks in the form of strengthening exercise, clam - shell exercise, and stretching exercise focusing on obturator internus muscle, range of motion exercise for the hip and pelvis musculature for 30 minute three times a week for consecutive 8 weeks , each type of exercise was performed for a duration of 6 seconds and repeated 10 times
15799434|NCT04455646|Behavioral|CBT-based, mobile-delivered, intervention platform|App of this platform have been shown to be associated with reduced psychopathology symptoms,including depressive symptoms, following treatment (i.e., relapse prevention). GGDE, which was specifically designed to address MDD related maladaptive beliefs and symptoms,includes different CBT-based intervention modules (nine active and one sham), as well as means for data collection and response monitoring. The active treatment modules will differ in the proportion of adaptive vs. maladaptive statements and the emphasis on particular content (e.g loneliness vs. hopelessness).
15799435|NCT04455633|Drug|LX9211 low dose|11-week assessment period
15799436|NCT04455633|Drug|LX9211 high dose|11-week assessment period
15799437|NCT04455633|Drug|LX9211 Placebo|11-week assessment period
15799438|NCT04455620|Biological|BNT151|intravenous
15799439|NCT04455607|Behavioral|perturbation training|A Randomized control trial we will compare two perturbation motor learning paradigms with different challenge level of the practice condition (i.e. blocked practice vs random practice). According to motor learning theory we hypothesize that a) healthy older adults will benefit more from random practice. The purpose of this stage is to investigate the effects of task practice order (random vs blocked) on motor learning (i.e. responding to perturbations during walking) in older adults. According to motor learning theory we hypothesize that a) healthy older adults will benefit more from the random motor learning approach as compared to using blocked practice.
15799440|NCT04455594|Drug|Almonertinib|Oral, 110mg QD
15799441|NCT04455594|Drug|Erlotinib|Oral, 150mg QD
15799442|NCT04455594|Drug|Cisplatin|Cisplatin(75mg/m2) be administered with pemetrexed (500mg/m2) on Day 1 of every 3-week cycle for 3 cycles
15799443|NCT04455594|Drug|Carboplatin|Carboplatin (AUC=5) to be administered with pemetrexed (500mg/m2) on Day 1 of every 3-week cycle for 3 cycles
15799444|NCT04455594|Drug|Pemetrexed|Pemetrexed (500mg/m2) to be administered with Cisplatin(75mg/m2) or Carboplatin (AUC=5) on Day 1 of every 3-week cycle for 3 cycles
15799445|NCT04455581|Drug|SHR-1209|SHR-1209 administered by subcutaneous injection Atorvastatin or Rosuvastatin combined with Ezetimibe oral
15799446|NCT04455568|Device|use EKG Wisdom bracelet|Non-invasive Wearable Device (use EKG Wisdom bracelet)
15799447|NCT04455555|Drug|LY03003( the name of rotigotine)|LY03003 (Continuous Dopamine Stimulation) sustained release microspheres / injection once a week 4 weeks followed by 24 weeks until 28 weeks.
15799448|NCT04455555|Other|Placebo|Null sustained release microspheres placebo / injection once a week 4 weeks followed by 24 weeks until 28 weeks.
15799449|NCT04455542|Other|LMND-ALS|in line with LMND -ALS inclusion criteria, and CMAP amplitude of peripheral motor nerves (CMAP amplitude of the 10 peripheral motor nerves with the most obvious CMAP amplitude decline was selected as the CMAP amplitude for grouping of the patients) was less than the median of CMAP amplitude of LMND -ALS group.
15799450|NCT04455542|Other|UMND-ALS|The main clinical manifestations were limb stiffness and spasm, obvious pyramidal tract signs, relatively mild muscle atrophy and fasciculation, and no significant decrease in amplitude of electromyography CMAP.
15799451|NCT04455542|Other|FAS and FLS|The clinical symptoms were confined to upper limbs (FAS) or lower limbs (FLS) for more than 12 months, and the main manifestations were lower motor neuron involvement signs such as muscle weakness and atrophy.
15799452|NCT04455529|Other|ESUS|Embolic stroke of undetermined source (ESUS) designates patients with nonlacunar cryptogenic ischemic strokes in whom embolism is the likely stroke mechanism.
15799453|NCT04455516|Procedure|Meniscus repair; partial meniscectomy|69 cases of meniscus repair (repair group) and 96 cases of partial meniscectomy (partial meniscectomy group), were retrospectively analyzed. The 69 patients of the repair group were divided into the nonfailure group (62 cases) and the failure group (7 cases) depending on the repair effect.
15799454|NCT04455503|Drug|EVX-02A|Up to 8 patients will receive EVX-02A administered IM.
15799455|NCT04455503|Drug|EVX-02B|Up to 8 patients will receive EVX-02B administered IM.
15799456|NCT04455503|Drug|EVX-02A OR EVX-02B|EVX-02A or EVX-02B will be used. Patients: 24 to 30
15799457|NCT04455490|Other|Self-control|We compared relevant scores of patients before and after surgery
15799458|NCT04455477|Drug|Nesiritide|The attending physicans decide whether to use Nesiritide for congestive heart failure patients. Only patients who will use Nesiritide are enrolled.
15799460|NCT04455438|Radiation|SBRT dose escalation|Re-Stereotactic Body Radiation Therapy (SBRT) with increasing dose levels, from 30 Gy in 5 fractions to 50 Gy in 5 fractions.
15799461|NCT04455412|Procedure|Laser Assisted ICSI|using OCTICS laser device to do small opening or zona thinning to improve ICSI outcome
15799462|NCT04455399|Device|Intravitreal injection guide (Malosa)|A single use, multifunction device will be used to push away an eyelid to expose injection site, indicate injection point about 4 millimeters from surgical limbus, and directs needle perpendicular to the ocular surface while limiting intraocular needle incursion
15799463|NCT04455399|Device|Dual Blade Eyelid Speculum|A conventional dual blade eyelid speculum will be use to push away eyelids. A Castroviejo surgical caliper will be used to mark the injection site.
15799625|NCT04454060|Procedure|Extracapsular arthroscopy|Extracapsular arthroscopy method was used to treat refractory tennis elbow
15799466|NCT04455360|Other|Eye Movement Desensitisation and Reprocessing Recent traumatic Event Protocol|EMDR is a form of psychotherapy treatment whereby the client verbally relates a narrative of a traumatic episode or emotionally disturbing material in brief sequential doses while simultaneously focusing on an external stimulus. The EMDR Recent-Traumatic Events protocol (R-TEP) aims to enable an individual to process memories of the event in order to reduce psychological morbidity. EMDR R-TEP should be delivered within 3-months of the onset of a traumatic event.
15799467|NCT04455334|Other|Error-augmented treadmill training|walk on split-belt treadmill
15799468|NCT04455334|Other|active control group|walk on tie-belt treadmill
15799469|NCT04455334|Other|Error-augmented concept combined physical therapy group|Error-augmented concept combined physical therapy
15799470|NCT04455334|Other|conventional physical therapy group|conventional physical therapy
15799471|NCT04455334|Other|NO INTERVENTION|NO INTERVENTION
15799472|NCT04455321|Procedure|Suture materials effect on istmocel|Effect of suture materials with different absorption times on istmocel
15799473|NCT04455308|Diagnostic Test|Biological sample collection|10mL blood sample
15799474|NCT04455295|Device|Transdermal Vagus Nerve Stimulation (tVNS)|Mild non-invasive transdermal electrical stimulation at the ear (0.0-1.0 mA, 0.0-30.0 Hz). Used in previous studies with no unexpected adverse events. Stimulator not considered a FDA regulated device in previous studies.
15799475|NCT04455269|Device|AIRFLOW® with PLUS® powder and PIEZON® scaler|Air-polishing will be use as main instrument for biofilm and stains removal, followed by ultrasonic scaling
15799476|NCT04455269|Device|PIEZON® scaler and rubber cup with abrasive paste|Application of ultrasonic scaler on the entire dentition, followed by residual biofilm and stains removal and polishing
15799477|NCT04455256|Other|x box binding protein|Serum value (pg / mL) of x box binding protein (XBP-1), which is one of the unfolded proteins indicating endoplasmic reticulum stress, is measured.
15799478|NCT04455243|Drug|N-Acetyl cysteine|150 mg/kg every 12 hours for 14 days (oral/IV) Diluted in 200 ml diluent (D5%, NS)
15799479|NCT04455243|Drug|Placebo|Matching placebo administered in the same schedule and volume as NAC
15799480|NCT04455230|Genetic|FLT190|FLT190 is a recombinant adeno-associated viral (AAV) vector (AAVS3) containing the human αGLA gene as a single stranded (ss) deoxyribonucleic acid (DNA).
15799481|NCT04455217|Other|data collection from patients with FAI (occuring January 2000 until December 2019)|data collection from patient files (data regarding surgery, adverse events, infections, demographic data)
15799482|NCT04455204|Diagnostic Test|Serum asymmetteric dimethyl arginine|Serum asymmetteric dimethyl arginine (ADMA) will be done using Enzyme-Linked Immunosorbent Assay
15799483|NCT04455204|Diagnostic Test|serum lipid profiles|serum lipid profiles including triglycerides (TG), total cholesterol and high-density lipoprotein cholesterol (HDL-C) which will be measured by enzymatic colorimetric method) using commercial kits
15799484|NCT04455204|Diagnostic Test|Serum vaspin|vaspin concentrations will be assayed using commercially available ELISA kits
15799485|NCT04455204|Diagnostic Test|Serum resistin|resistin concentrations will be assayed using commercially available ELISA kits
15799486|NCT04455191|Procedure|Thawing Embryos in Advance|Thaw Embryos one day in Advance
15799487|NCT04455191|Procedure|Thawing Embryos on the Day of Transfer|Thaw Embryos on the morning of transfer day.
15799488|NCT04455178|Drug|Spironolactone|spironolactone 20mg once daily, up-titrated to 40mg once daily at 4-week or 8-week visit
15799489|NCT04455178|Drug|Indapamide|indapamide 1.5mg once daily, up-titrated to 3mg once daily at 4-week or 8-week visit
15799490|NCT04455165|Procedure|Aortic valve replacement|Aortic valve replacement with or without associated cardiac surgery (coronary bypass, mitral valve surgery,...)
15799491|NCT04455152|Behavioral|self-control|avoiding eating sweets as a way of building self-control strength
15799492|NCT04455139|Drug|Topotecan|intravitreal or intra-arterial administration of topotecan
15799493|NCT04455139|Drug|Melphalan|intravitreal or intra-arterial administration of topotecan
15799494|NCT04455126|Drug|Preservative-free tafluprost eye drops|This was an open-label, non-randomized clinical study that aimed to assess the ocular signs and symptoms in 60 eyes of 30 newly diagnosed Egyptian glaucoma patients receiving preservative-free tafluprost eye drops
15799495|NCT04455113|Diagnostic Test|Phosphorus level|infusion
15799497|NCT04455087|Other|sensitization|sensitization of doctor to decrease the prescription of abuse exams
15799498|NCT04455074|Other|FN scale auto-questionnaire|Patients will be asked to fill in the NF scale questionnaire together with other tests and rating scales, during a routine L-Dopa test, in 2 conditions: OFF-med and ON-med.
15799499|NCT04455048|Other|Cervicothoracic thrust manipulation|The patient will be positioned in a supine position with arms crossed over over the trunk and holding the shoulders. The therapist will place a stabilizing hand over transverse process of T1 in pistol grip and contacted patients elbow with sternum and patient will be asked do a hip bridge while taking a deep breath than exhale. Thrust manipulation will be applied at the end of exhale.
15799500|NCT04455048|Other|Cervicothoracic thrust manipulation sham|The patient will be positioned in a supine position with arms crossed over over the trunk and holding the shoulders. The therapist will place a stabilizing hand over transverse process of T1 in pistol grip and contacted patients elbow with sternum and patient will be asked do a hip bridge while taking a deep breath than exhale. A soft compression will be applied at the end of exhale without a thrust.
15799501|NCT04455035|Other|Comparator: Retrospective Group(Control)|The control group for this study will be obtained from a retrospective chart review of electronic health records of patients with incomplete cleft lip who underwent surgery without any presurgical interventions.
15799524|NCT04454866|Drug|Single injection of penehyclidine|A dose of penehyclidine hydrochloride (0.5 mg/5 ml) is injected intravenously before anesthesia induction. A patient-controlled intravenous analgesia pump is provided after surgery, which is established with a mixture of placebo (normal saline 5 ml), sufentanil (1.25-1.5 ug/kg) and tropisetron (10 mg), diluted with normal saline to 100 ml, and programmed to administer a continuous infusion at a rate of 2 ml/h for 48 hours.
15799626|NCT04454047|Procedure|Extracapsular arthroscopy|Extracapsular arthroscopy method was used to treat refractory tennis elbow
15799627|NCT04454034|Procedure|arthroscopic synovectomy|arthroscopic synovectomy
15799502|NCT04455035|Device|Prospective Group|"The study population for the prospective aspect will include recruited newborns with untreated unilateral incomplete cleft lip.
~DynaCleft® + Nasal Elevator therapy will be discussed with parent(s) as a presurgical orthopedic option while awaiting primary cleft lip surgical repair that typically occurs between the ages of 3 to 6 months.Study duration will be up to three months of presurgical intervention.Photographs are to be taken at initial visit prior to presurgical intervention and later at completion of the DynaCleft® therapy immediately prior to lip surgery. Angles to be pictured are to include the standard anterior-posterior, profile, and worms-eye view.
~Linear measurements will be obtained with a ruler and registered in millimeters. A goniometer will be used to measure angles."
15799503|NCT04455022|Other|Bedside blood culture bottles weighing combined with educational interventions.|Educational actions will be taken to raise the awareness of importance of collecting adequate volume of blood for culture (posters, leaflets and educational activities). The minimum volume will be defined as at least 1 ml. The paramount role of blood culture in process of ruling out newborn sepsis will be emphasized. The sample volume control by using bedside precision scale will be introduced.
15799504|NCT04455009|Dietary Supplement|Fitness Drink Formula|Single drink provided following baseline assessments
15799505|NCT04454996|Drug|tong-jiang granules|This is a kind of compound Chinese medicine granules, 1 bag each time, 3 times a day, treatment for 4 weeks.
15799506|NCT04454996|Drug|Chang 'an II Recipe|This is Chang 'an II Prescription granule, 1 bag each time, 3 times a day, treatment for 4 weeks.
15799507|NCT04454996|Drug|The placebo of tong-jiang granules|This is a granule, containing 5% tongyu granule active drug,1 bag each time, 3 times a day, treatment for 4 weeks.
15799508|NCT04454996|Drug|The placebo of Chang 'an II Recipe|This is a granule containing 5% chang 'an II,1 bag each time, 3 times a day, treatment for 4 weeks.
15799509|NCT04454983|Device|Lipiflow Thermal Pulsation System|The LipiFlow Console provides the user interface and control elements of the system, including all software, algorithms and control elements. The Activator, a single-use sterile device, delivers automated therapeutic energies to each meibomian gland. Its contoured design vaults the cornea and protects the eye allowing a maximum therapeutic temperature of 43 degrees Celsius to reach glands from the inner eyelid. Insulation protects the cornea from exceeding a safe 39.5 degrees Celsius, while a pressure feedback loop sends pulsed sequences to expel blockages. Force equalization protects the globe from pressure transmission by focusing energy only on the eyelid. Delivered through the LipiFlow Activator, Vectored Thermal Pulse™ technology applies a combination of heat and pressure to the inner eyelid to safely remove gland obstructions and stagnant gland content. Therapeutic motion provides proximal-to-distal peristalsis to clear gland contents.
15799510|NCT04454983|Device|iLux System|The iLux™ System is used to apply localized heat and pressure to a patient's eyelids. The system consists of a handheld instrument coupled to a single-use, sterile disposable component that is positioned to bridge the eyelid. The iLux device allows view of the eyelid through a magnifier, then warms the eyelid to 40 to 42˚C, then force-limited compression is applied manually to express the melted meibum from obstructed glands. Warming is accomplished using light energy emitted from LEDs in the Instrument. The LEDs are located behind a clear window on the open end of the Shroud. Two wavelengths of light are used: lime-green (568 nm) and near-infrared (850 nm). A mechanism in the Instrument allows the operator to apply pressure to the eyelid by controlling the movement of the Outer Pad using finger pressure applied to the Compression Control button. The force applied to the Compression Control is measured by a sensor in this mechanism.
15799511|NCT04454970|Device|Urethrotech Urethral catheterisation device (UCD)|Urethral indwelling catheter
15799512|NCT04454970|Device|Bardia Aquafil long term catheter|Urethral indwelling catheter
15799513|NCT04454957|Behavioral|Mastering Diabetes|Virtual (on-line) lifestyle change program, focused on a plant-based, whole food diet and physical activity.
15799514|NCT04454944|Behavioral|LPG subsidy|Different subsidy rates, ranging between 0% and 100% (listed below) will be written on cards. Individuals will randomly select a card to display the subsidy rate for each household. The card will be concealed with a scratch-off sticker, with a higher likelihood of drawing a high price (low subsidy) than a low price (high subsidy) given that take up will be higher in the latter group.
15799515|NCT04454944|Behavioral|Distance allocation|We will set up fuel supply depots to increase the convenience and lower costs and hassle associated with traveling to an established filling station. The supply depots will mirror a recirculation model of LPG distribution currently being piloted by the National Petroleum Authority of Ghana. Households will be randomly assigned to one of the supply depots in advance or to continue refilling their cylinder at the filling station.
15799516|NCT04454931|Device|Root® with O3® Regional Oximetry|"May help clinicians monitor cerebral oxygenation in situations in which pulse oximetry alone may not be fully indicative of the oxygen in the brain.
~It was aimed to determine the appropriate head height that should be given to patients in order to correct the endotracheal suctioning sequence, which is the most important care application of the neurosurgery patients who are followed up in the intensive care unit after surgery, and the possibility of subsequent disruption of cerebral perfusion. Therefore, cerebral oxygenation status, which is the most important parameter that shows the cerebral perfusion status of patients during and after the application, will be followed up by nurses with a non-invasive cerebral oximeter device."
15799517|NCT04454918|Drug|TAK-906 Oral Capsule|TAK-906 capsule.
15799518|NCT04454918|Drug|[14C]-TAK-906 Intravenous Infusion|[14C]-TAK-906 intravenous infusion.
15799519|NCT04454918|Drug|[14C]-TAK-906 Oral Solution|[14C]-TAK-906 oral solution.
15799520|NCT04454905|Drug|Camrelizumab|Camrelizumab (Jiangsu HengRui Medicine Co., Ltd.) is a recombinant anti-human PD-1 IgG4 monoclonal antibody.
15799521|NCT04454905|Drug|Apatinib|Apatinib is a novel angiogenesis inhibitor vascular endothelial growth factor 2.
15799522|NCT04454892|Other|Amyotrophic lateral sclerosis|AMYOTROPHIC lateral sclerosis (ALS) is a degenerative disorder of motor neurons in the cortex, brainstem and spinal cord1,2. Its cause is unknown and it is uniformly fatal, typically within five years3
15799523|NCT04454879|Drug|Roxadustat|Patients in the standard dosage group will receive starting dosage of roxadustat 100 mg, three times per week for weight 45-60kg and 120 mg, three times per week for weight greater than 60kg. Patients in the lower dosage group will receive the starting dosage of roxadustat 50 mg, three times per week for weight lower than 50kg, 70 mg, three times per week for weight 50-70kg, 90 mg, three times per week for weight 70-90kg and 110 mg, three times per week for weight 90-110kg, respectively.
15799525|NCT04454866|Drug|Continuous infusion of penehyclidine|A dose of penehyclidine hydrochloride (0.25 mg/5 ml) is injected intravenously before anesthesia induction. A patient-controlled intravenous analgesia pump is provided after surgery, which is established with a mixture of penehyclidine hydrochloride (0.25 mg/5 ml), sufentanil (1.25-1.5 ug/kg) and tropisetron (10 mg), diluted with normal saline to 100 ml, and programmed to administer a continuous infusion at a rate of 2 ml/h for 48 hours.
15799526|NCT04454866|Drug|Placebo|A dose of placebo (normal saline 5 ml) is injected intravenously before anesthesia induction. A patient-controlled intravenous analgesia pump is provided after surgery, which is established with a mixture of placebo (normal saline 5 ml), sufentanil (1.25-1.5 ug/kg) and tropisetron (10 mg), diluted with normal saline to 100 ml, and programmed to administer a continuous infusion at a rate of 2 ml/h for 48 hours.
15799527|NCT04454853|Other|Lung cancer|Paraneoplastic neurological syndrome (PNS) is a clinical syndrome that affects the central nervous system, peripheral nerves, neuromuscular junctions and muscles by the distant influence of the tumor. No tumor cells are visible at the neuropathy site.
15799528|NCT04454853|Other|Suspected lung cancer|Paraneoplastic neurological syndrome (PNS) is a clinical syndrome that affects the central nervous system, peripheral nerves, neuromuscular junctions and muscles by the distant influence of the tumor. No tumor cells are visible at the neuropathy site.
15799529|NCT04454853|Other|Positive methylated DNA|Tumor-free DNA (cfDNA) methylation detection is to determine the cancer condition and cancer type of the subject by detecting the methylation of free DNA released by tumor cells.
15799530|NCT04454840|Biological|Plasma from healthy young people treatment + Riluzole|Intravenous injection: the subjects received 400ml of intravenous plasma infusion every 2 weeks, with a continuous course of 2 treatments and a course of treatment every 3 months. The course of treatment lasted 10 months, with a total of 3200ml of plasma infusion.
15799531|NCT04454840|Drug|Riluzole|The basic treatment is Riluzole 25~50mg twice daily
15799532|NCT04454814|Other|Protaper Universal instruments|Root canal treatment using Protaper Universal instruments
15799533|NCT04454814|Other|Reciproc Blue instruments|Root canal treatment using Reciproc Blue instruments
15799534|NCT04454788|Drug|Tenecteplase|Genetically modified tissue plasminogen activator at a dose of 0.25mg/kg given as intravenous bolus over 5-10 seconds
15799535|NCT04454788|Drug|Standard Care (which may include intravenous Alteplase)|Patients will receive standard care which may include intravenous alteplase at the standard licensed dose of 0.9 mg/kg up to a maximum of 90mg, 10% as bolus and the remainder over 1 hour.
15799536|NCT04454775|Diagnostic Test|coagulation system parameters; factor 8, von Willebrand factor, protein C, protein S, antithrombin III and fibrinogen were studied.|
15799537|NCT04454762|Drug|Cabozantinib|oral administration (40 mg daily, reduced dose 20 mg daily)
15799538|NCT04454749|Diagnostic Test|Blood test|Mesurement of E2, P4, LH, FSH hormones
15799539|NCT04454749|Diagnostic Test|Ultrasound|Follicular measurement and endometrium measurement
15799540|NCT04454736|Behavioral|"Amateur Group Singing"|45-minute singing session led by a professional choirmaster without a therapeutic background once a week
15799541|NCT04454736|Behavioral|"Professional Group Singing"|120-minute singing session led by a professional choirmaster without a therapeutic background three times a week. Assessments take place twice a week.
15799542|NCT04454723|Procedure|Blood and/or platelet transfusion|The transfused patients will receive one unit each of blood and/or platelet transfusions once a week based on CTCAE symptom grade 2 or greater of anemia and/or thrombocytopenia.
15799543|NCT04454723|Procedure|Complete blood count (CBC) collection|CBC will be collected from patients weekly while on this protocol.
15799544|NCT04454710|Device|Pulsed Radiofrequency|Pulsed radiofrequency is a novel therapeutic modality with many potential applications in pain management.
15799545|NCT04454697|Device|tissue retractors|Patients receive a tissue retractor to spare healthy tissue during the course of radiation
15799546|NCT04454684|Drug|MDMA|Initial dose of 80 or 120 mg MDMA administered orally at the start of each of three psychotherapy sessions, followed by a supplemental half-dose of 40 to 60 mg MDMA 1.5 to 2.5 hours later, unless contraindicated.
15799547|NCT04454684|Behavioral|Non-directive Psychotherapy|Non-directive psychotherapy will be conducted during Experimental Sessions.
15799548|NCT04454684|Behavioral|Psychotherapy|Psychotherapy will be conducted during Preparatory Sessions and Integrative Sessions.
15799554|NCT04454645|Behavioral|mABC|Intervention targets parenting sensitivity and nurturance.
15799555|NCT04454645|Behavioral|mDEF|Intervention targets parenting enhancing infant cognitive development
15799556|NCT04454632|Other|Mirror therapy|affected arm stay behind the mirror while exercising
15799557|NCT04454632|Other|Visual feedback|visual feedback from mirror
15799558|NCT04454619|Drug|Hand antisepsis with Clorhexidine and solution|Hand antisepsis by scrub Surgical Hand scrubbing using chlorhexidine digluconate with the addition of an alcoholic solution of chlorhexidine digluconate and potassium sorbate. both hands using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side
15799588|NCT04454372|Other|demographic and clinical data obtained from hospital's electronic medical record.|This retrospective observational study. . Demographic and severity data will include age, sex, SAPS 3 and SOFA scores at admission, nutritional risk determined by NRS-2002 and commodities. Clinical and laboratory data on arrival at the ICU including PaO2 / FIO2, blood count and PCR D-dimer, ferritin, fibrinogen, DHL. Drug interventions including use of hydroxychloroquine, corticosteroids, heparin, tocilizumab. Characteristics of invasive and non-invasive respiratory support, use of prone position and ECMO and vasoactive drugs. The main complications, acute kidney injury requiring renal replacement therapy, secondary infectious complications will be documented as well as the outcomes.
15799559|NCT04454606|Device|Fit test|"Bitrex Fit Test The Bitrex test uses a person's ability to test a bitter solution to determine whether a respirator fits properly[11]. Each subject was given a taste-threshold screening test prior to each fit test to ensure that he or she could taste. This process was done without subject wearing a respirator. After passing the sensitivity test, the subject will process to 7 steps of fit test as following
~Breathe normally
~Breathe deeply
~Head side to side
~Head up and down
~Bent over wrist, jogging
~Talking
~Breath normally Each step took 60 seconds and the Bitrex solution was refilled into the hood every 30 seconds with half dosage of the amount of the previously test. We asked the participant if he / she could taste the solution during each steps of the test . The test was considered a failure, otherwise, a pass."
15799560|NCT04454606|Device|Filtration Test|"Respirator Performance
~The real time respirator performance test method was developed using MT-05U machine (SIBATA model, Saitama, Japan), which measure particle concentrations of diameter 0.03 - 0.06 µm using and particle generator laser beam scattering particle counter that measure particles outside and inside the mask. The ratio between these two values reflected % leak as following:
~leak=((Paticle inside the filter))/((Paticle inside the filter)) x 100 And calculate % filter performance = 100 - % leak We tested at the airflow rate of 40L/min which is 3-4 times higher than normal physiology, assuming that there should be no leakage through the filter. We tested 2 types of filter is CareStar and SafeStar that was incorporated with the silicone mask. CareStar is limited for 24 hour usage and SafeStar is for 72 hour duration.
~Study protocol"
15799561|NCT04454593|Other|no intervention|This is an observation study,with no intervention
15799562|NCT04454580|Drug|Venetoclax|treatment with azacitidine or decitabine in combination with venetoclax
15799563|NCT04454567|Drug|ABI-H0731|Participants will receive ABI-H0731 tablets orally once daily
15799564|NCT04454567|Drug|Placebo|Participants will receive placebo to ABI-H0731 tablets orally once daily
15799565|NCT04454567|Drug|NrtI|Entecavir (ETV), tenofovir alafenamide (TAF), or tenofovir disoproxil fumarate (TDF) SOC according to the respective package insert
15799566|NCT04454541|Procedure|Ultrasound-guided nerve block for headache management|The study was done to compare the efficacy of two different techniques: multifidus cervicus plan block and greater occipital nerve block in treatment of refractory cervicogenic headache using ultrasound guided.
15799567|NCT04454528|Radiation|Hypofractionated radiotherapy|Radiation boost (RT) 7 Gy x 1 fraction on Day -14/Day -7 (arm 1) or Day -7/Day -14
15799568|NCT04454528|Drug|Pembrolizumab infusion|Pembrolizumab infusion flat dosing 200 mg delivered over 30 minutes.
15799569|NCT04454528|Procedure|Blood and tissue sampling|"Blood will be collected for laboratory studies and complete correlative studies to examine how the subject's immune system is responding to treatment.
~On day 0, samples of tumor and any lymph nodes removed from armpit will be analyzed by the UPenn Department of Pathology according to standard practice."
15799570|NCT04454515|Drug|Dexmedetomidine|Dexmedetomidine is an α2 receptor agonist with sedative and analgesic properties. In previous reports, dexmedetomidine improves smoothness of postoperative recovery and reduces intraoperatory imflammatory responses. As patients receiving breast surgeries are especially vulnerable to postoperative nausea/ vomiting, the dosage of narcotics and associated complications were concerned for not only comfortness but also postoperative oral intake and discharge.
15799571|NCT04454515|Drug|placebo|normal saline infusion
15799572|NCT04454502|Other|Oral colostrum administration|In accordance with the oral colostrum protocol, a total of 0.2ml colostrum will be administered into the cheek and on the tongue for the infants weighing between 1001-1500 g.
15799573|NCT04454489|Drug|Pembrolizumab (immunotherapy)|Pembrolizumab 200 mg will be given every 3 weeks to tumor progression or treatment tolerance.
15799574|NCT04454489|Radiation|Quad-shot palliative radiotherapy|"Each cycle of quad-shot radiotherapy will be comprised of 14.8 Gy in 4 fractions (3.7 Gy per fraction) delivered twice daily (at least 6 hours apart) over two consecutive days.
~All patients will receive 1 cycle of quad-shot radiotherapy between ICI cycles 2-3.
~Subsequent cycles may occur between immunotherapy cycles 6-7 and 11-12, if more than 1 cycle can be safely delivered and the patient has experienced less than a partial response at protocol-specified tumor assessments (after C5 and C10). The eligibility for subsequent cycles will be at the discretion of the treating radiation oncologist.
~Therefore, the total prescription dose will be:
~14.8 Gy in 4 fractions for those that complete 1 cycle (all patients will receive 1 cycle)
~19.6 Gy in 8 fractions for those that complete 2 cycles
~44.4 Gy in 12 fractions for those that complete 3 cycles"
15799577|NCT04454450|Diagnostic Test|PET/MRI|Imaging will include research PET/MRI of pelvis within 30 days of multiregion tissue collection.For research PET/MRI - standard volumes of gadolinium contrast and fluorodeoxyglucose (FDG) will be administered.
15799578|NCT04454450|Diagnostic Test|Contrast enhanced CT|Standard of care contrast enhanced CT
15799579|NCT04454437|Biological|Sacituzumab Govitecan|10 mg/kg intravenously on Days 1 and 8 of a 21-day cycleNA. Number of Cycles: until disease progression or intolerable toxicity or consent withdrawal for any reason.
15799580|NCT04454424|Drug|BAY1817080|Study intervention BAY1817080 will be administered orally with tablet(s).
15799581|NCT04454424|Drug|Midazolam|Midazolam will be administered intravenously with dose of 0.1 mg on Day 1.
15799582|NCT04454411|Drug|Brixadi|Extended release injectable Buprenorphine
15799583|NCT04454411|Drug|Vivitrol|Extended release injectable Naltrexone
15799584|NCT04454398|Biological|COVI-GUARD|COVI-GUARD (STI-1499) is a monoclonal antibody which targets the COVID-19 spike protein
15799585|NCT04454398|Other|Standard of Care|Standard of Care as determined by the Investigator
15799586|NCT04454398|Drug|Placebo|Diluent
15799587|NCT04454385|Diagnostic Test|Patients with well controlled asthma|"Patients with well controlled asthma
~The following parameters are to be evaluated:
~Blood eosinophils FeNO Findings on lung function test"
15799589|NCT04454359|Dietary Supplement|Multi-nutrient supplement|
15799590|NCT04454359|Dietary Supplement|Placebo|
15799591|NCT04454346|Device|Double Foley Catheter For Ripening The Unfavorable Cervix|New methot
15799592|NCT04454320|Other|INTUSSUSCEPTION IN CHILDREN|the seasonal variation and management outcomes of childhood intussusception.
15799593|NCT04454307|Drug|Tramadol|tramadol 100 mg twice daily for 10 days
15799595|NCT04454294|Other|Control|"Common Process Steps:
~Informed consent forms will be signed by those who wish to take part in the research.
~The form in which individual characteristics are questioned will be filled.
~Hands will be washed, gloves will be worn.
~Before the procedure, body temperature, heart rate, respiratory rate, blood pressure, oxygen saturation and bleeding amount will be recorded.
~Drains will be kept parallel to the ground and upright.
~Drainage hoses will not be bent and in-bed position will be provided in accordance with gravity.
~It will be ensured that all connections between the chest tubes and drainage unit are tight and secure.
~Dressings of the chest and mediastinum drains will be fixed on the patient's skin, so as not to interfere with drainage.
~To prevent the tubes from coming out, they will be fixed to the patient bed.
~Vital signs, Sp02 and bleeding amount will be recorded every hour for 6 hours after surgery"
15799596|NCT04454294|Other|Experimental Group (Absorption Group)|"Common process steps
~Appropriate negative pressure monitoring system of the patient, who is admitted to the intensive care unit with underwater drainage system, will be established.
~The suction control room combined with the vacuum regulator will be filled with sterile distilled water up to the specified level (20 cm H2O).
~From the vacuum regulator, the drain or drains will be connected tightly and by preventing the crimping, from the aspirator receptor hoses.
~Suction will begin with a low level and gradually increase the suction until a slight bubble is noticed in the suction control room.
~Suction pressure will be maintained between 5 and 15 kPa (kilopascals) or 10-20 cm H20.
~The application will continue without interruption until the patient's drain need and the doctor's request is ended.
~During the application, the patient's vital signs, Sp02 and bleeding amount will be recorded every hour without using an additional manipulation method."
15799597|NCT04454294|Other|Experimental Group (Milking Group)|"Common process steps will be applied
~Operation will start from the area near the drain entrance point
~Latex tube will be folded into 12 cm long pieces and will be gripped with two hands
~The procedure will be repeated 3 times by compressing the parts gripped by the nurse hand.
~This process will be repeated in the distal part.
~After the application, the patient's vital signs, Sp02 and bleeding amount will be recorded every hour without using an additional manipulation method."
15799598|NCT04454281|Drug|Naloxone Hydrochloride 0.4 MG/ML|Drug will be topically applied to the corneal surface then study evaluations will ensue.
15799599|NCT04454268|Procedure|cyst extirpation|complete removal of the cyst without rupture
15799600|NCT04454255|Behavioral|FunSpeech|Weekly sessions of regular speech therapy as regularly performed for the individual participant (one hour, once or twice a week) and parent-supervised home use of a serious game. It will be recommended to use FunSpeech every day, 15 minutes per day.
15799601|NCT04454255|Behavioral|Control|Weekly sessions of regular speech therapy as regularly performed for the individual participant (one hour, once or twice a week).
15799602|NCT04454242|Other|Expiratory muscle trainig|This exercise will be used to strengthen forced expiratory muscles.
15799603|NCT04454229|Other|Direct oral penicillin challenge|The patient will receive a single dose of oral penicillin, following baseline vital signs.
15799604|NCT04454229|Other|Standard of care|Routine management as per the treating clinicians that include skin prick and intradermal beta-lactam testing, followed by oral penicillin challenge in the setting of negative skin testing.
15799605|NCT04454203|Drug|Mepivacaine|An infiltration of mepivacaine superomedially to the femoral artery via perineural catheter.
15799606|NCT04454203|Drug|Saline|An infiltration of saline superomedially to the femoral artery via perineural catheter.
15799607|NCT04454203|Procedure|Perifemoral Injection of Local Anesthetic|Infiltration of mepivacaine superomedially to the formal artery via perineural catheter in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.
15799608|NCT04454203|Procedure|Perifemoral Injection of Local Anesthetic|Infiltration of saline superomedially to the formal artery via perineural catheter that should NOT numb the nerves that contribute to tourniquet hypertension intraoperatively.
15799609|NCT04454190|Diagnostic Test|Collection of genetic material|Blood samples will be processed for extraction of DNA and genotyping. 10 ml of blood will be collected using standard procedures. The samples will be de-identified and receive a masked ID which will correspond to the existing masked ID in the DGR database. 2 ml will be sent to Genentech using frozen samples for genotyping using the Illumina Global Screening Array (GSA) kit. The remaining will be processed and stored at the Duke Eye Center. These samples may be maintained indefinitely or until they are exhausted. These samples will not be available for diagnostic or therapeutic purposes.
15799610|NCT04454177|Device|HUAWEI watch|HUAWEI Watch will be assigned to patients within 24 hours before TAVR. HUAWEI Watch GT series can continuously monitor and record multiple biometric parameters heart rate, step counts, sleep cycles and can detect and record the pulse oxygen saturation, as well as analyze QRS complexes and P waves after triggering.
15799611|NCT04454164|Biological|PRP|platelet rich plasma
15799612|NCT04454164|Drug|Saline|serum physiologic
15799613|NCT04454151|Drug|Azithromycin Tablets|given PO Azithromycin 250 mg X1 daily, for 4 months, followed by a non-treatment follow-up period of 12 month.
15799614|NCT04454138|Device|XEN-45 gelatin microstent|Placement either in the subconjunctival space or supratenon's area
15799615|NCT04454125|Behavioral|AQI intervention|The intervention arm will receive AQI education, an asthma action plan containing AQI information and recommendations, and will be required to demonstrate ability to check AQI (either via airnow.gov website or downloaded AirNow smartphone app).
15799616|NCT04454125|Other|Routine care|The routine care arm will be provided with general AQI education and an asthma action plan not containing AQI information.
15799617|NCT04454112|Device|24-hour esophageal pH monitoring using an ambulatory system (Ohmega, MMS, Enschede, The Netherlands).|24-hour esophageal pH monitoring application
15799618|NCT04454099|Diagnostic Test|4 kind of FOBT and colonoscopy with pathological examination|Detect Hb in stool by 4 kind of FOBT and detect colon lesion using colonoscopy and pathological examination.
15799619|NCT04454086|Other|Aerobic Exercise|Undergo aerobic exercise
15799620|NCT04454086|Other|Exercise Counseling|Receive behavioral activity counseling
15799621|NCT04454086|Other|Nutritional Assessment|Receive nutritional counseling
15799622|NCT04454086|Other|Quality-of-Life Assessment|Ancillary studies
15799623|NCT04454086|Other|Questionnaire Administration|Ancillary studies
15799624|NCT04454086|Other|Resistance Training|Undergo resistance exercises
15799912|NCT04451863|Drug|Low THC|Vaporized THC (5 mg)
15799628|NCT04454021|Procedure|hip arthroscopy|hip arthroscopy was performed when symptoms were not alleviated by nonsurgical treatment
15799629|NCT04454008|Behavioral|executive function family training|Intervention programs include executive function training for children with ADHD and parenting guidance for parents
15799630|NCT04454008|Behavioral|treat as usual|Outpatient routine health education, behavioral guidance and family support
15799631|NCT04453982|Other|Human milk donors|Human milk donors for the Rogers Hixon Ontario Human Milk Bank
15799632|NCT04453969|Other|COVID-19|Exposure of interest for this observational study is current COVID-19 positive status or COVID-19 positive status during pregnancy
15799633|NCT04453956|Diagnostic Test|Colonoscopy with the assistance of EndoAngel's polyp detection function.|Patient in this group will receive colonoscopy with assistance of EndoAngel's polyp detection function,which can remind endoscopists of the location of the polyp.
15799634|NCT04453956|Diagnostic Test|Colonoscopy with the assistance of EndoAngel's quality monitoring function.|Patient in this group will receive colonoscopy with assistance of EndoAngel's quality monitoring function,which can monitor the withdrawal speed of the endoscope.
15799635|NCT04453956|Diagnostic Test|Colonoscopy without the assistance of EndoAngel's any function.|Patient in this group will receive colonoscopy with assistance of EndoAngel's both functions.
15799636|NCT04453943|Device|Exoskeleton Walking - with or without FES|The study involves validation of computer algorithms to estimate and control walking movements. The Rifton E-Pacer motorized walker, arm crutches, parallel bars, or a conventional walker may be used in order to assist donning and doffing of the exoskeleton system, standing, and walking for all subjects, at any time during experimentation. Walking movements will be elicited by the hybrid walking platform that combines a powered exoskeleton and an FES system. The powered exoskeleton can provide joint actuation at the hip and knee joints of a participant. The FES system can stimulate the quadriceps, hamstrings muscle, glutes, and ankle muscles.
15799637|NCT04453943|Device|Exoskeleton Sitting to Standing - with or without FES|The study involves validation of computer algorithms to estimate and control sitting/standing movements. The Rifton E-Pacer motorized walker, arm crutches, parallel bars, or a conventional walker may be used in order to assist donning and doffing of the exoskeleton system, standing, and walking for all subjects, at any time during experimentation. Sitting/Standing movements will be elicited by the hybrid walking platform that combines a powered exoskeleton and an FES system. The powered exoskeleton can provide joint actuation at the hip and knee joints of a participant. The FES system can stimulate the quadriceps, hamstrings muscle, glutes, and ankle muscles.
15799638|NCT04453930|Drug|Camrelizumab，an engineered anti-PD-1 antibody|Camrelizumab intravenous infusion was administered at a dose of 200 mg on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4/5/6) and maintenance phase (Cycle onward).
15799639|NCT04453930|Drug|Platinum|"Carboplatin： Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4/5/6).
~Cisplatin： Cisplatin intravenous infusion was administered at a dose of 30 milligrams per square meter (mg/m^2) on Day 1，8 of every 21-day cycle during the induction phase (Cycles 1-4/5/6)."
15799640|NCT04453930|Drug|Irinotecan|Irinotecan intravenous infusion was administered at a dose of 65 milligrams per square meter (mg/m^2) on Day 1，8 of every 21-day cycle during the induction phase (Cycles 1-4/5/6).
15799641|NCT04453930|Drug|Apatinib|Apatinib was administered at a dose of 250 mg during the maintenance phase.
15799642|NCT04453917|Biological|Collection of blood and urine|Collection of blood (47 mL) and urine (5 mL) at PML diagnosis and 1, 3 and 6 months after, for analysis of immune checkpoint molecules expression, detection of antiviral immune responses and virological analyses.
15799643|NCT04453917|Biological|Spinal tap|Spinal tap for monitoring of JC viral load at PML diagnosis and 1, 3 and 6 months after, and collection of CSF (2 mL) for virological analyses.
15799644|NCT04453917|Diagnostic Test|Brain MRI|Brain MRI at at PML diagnosis and 3 and 6 months after
15799645|NCT04453917|Biological|Neurological evaluation|Neurological evaluation at PML diagnosis and 1, 3 and 6 months after
15799646|NCT04453904|Other|"sequential radiochemotherapy in a sanwich mode"|Patients will randomized into two different modalities of radiochemotherapy.
15799647|NCT04453891|Device|Monitoring physiological data with the Hexoskin smart shirt|Participants will be monitored using a validated biometric garment (Hexoskin smart shirt). Cardiorespiratory and activity data will be collected over a 28-day monitoring period. Participants will be invited to wear the shirt during the day and at night.
15799648|NCT04453865|Behavioral|Project EMPOWER|Project EMPOWER is a web-based, self-administered SSI for parents that takes about 30 minutes to complete
15799649|NCT04453865|Other|Online Resources and Referrals|Information sheet containing materials about the nature of child anxiety and a list of national resources related anxiety treatment.
15799650|NCT04453852|Biological|COVID19 vaccine|COVID19 recombinant spike protein with Advax-SM adjuvant
15799651|NCT04453852|Biological|Saline|Saline control
15799652|NCT04453839|Drug|ZYESAMI (aviptadil acetate)|Patients will be treated with 12 hour infusions of ZYESAMI at ascending doses of 50/100/150 pmol/kg/hr on 3 successive days
15799653|NCT04453826|Drug|Camrelizumab plus chemo-radiotherapy|"Camrelizumab: 200 mg, intravenous injection over 60 minutes (Q3W); 2 cycles of camrelizumab are concurrently used during radiotherapy and camrelizumab are maintained for 1 year after the end of radiotherapy.
~Gemcitabine plus cisplatin induction chemotherapy: gemcitabine is injected intravenously at the dose of 1000 mg/m2 on the 1st and 8th day (within 30 minutes) for 3 cycles; cisplatin is injected intravenously at the dose of 80 mg/m2 on the 1st day, for 3 cycles. 1 cycles per 3 weeks.
~Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks.
~IMRT: PTVnx#69.96Gy/33Fr/2.12Gy; PTVnd#69.96Gy/33Fr/2.12Gy; PTV1#59.4Gy/33Fr/1.8Gy; PTV2#54Gy/33Fr/1.64Gy"
15799654|NCT04453826|Drug|Chemo-radiotherapy alone|"Gemcitabine plus cisplatin induction chemotherapy: gemcitabine is injected intravenously at the dose of 1000 mg/m2 on the 1st and 8th day (within 30 minutes) for 3 cycles; cisplatin is injected intravenously at the dose of 80 mg/m2 on the 1st day, for 3 cycles. 1 cycles per 3 weeks.
~Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks.
~IMRT: PTVnx#69.96Gy/33Fr/2.12Gy; PTVnd#69.96Gy/33Fr/2.12Gy; PTV1#59.4Gy/33Fr/1.8Gy; PTV2#54Gy/33Fr/1.64Gy"
15799655|NCT04453813|Drug|Toripalimab plus concurrent chemo-radiotherapy|"Toripalimab: 240 mg, intravenous injection over 60 minutes (Q3W); 2 cycles of toripalimab are concurrently used during radiotherapy and other 9 cycles of toripalimab are used after the end of radiotherapy. (A total of 11 cycles).
~Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks.
~IMRT: PTVnx#60.0Gy/27Fr/2.22Gy; PTVnd# 60-64Gy/27Fr/2.22-2.37Gy; PTV1#54Gy/27Fr/2.00Gy"
15799656|NCT04453813|Drug|Concurrent chemo-radiotherapy|"Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks.
~IMRT: PTVnx#60.0Gy/27Fr/2.22Gy; PTVnd# 60-64Gy/27Fr/2.22-2.37Gy; PTV1#54Gy/27Fr/2.00Gy"
15799657|NCT04453800|Drug|sofadil【Neu2000KW】|500mg Intravenous infusion of sofadil starting at 500mg was 500ml，followed by nine intravenous infusions, each 250mg infusion with 250ml sofadil for 5 days, and each interval is 12 hours
15799658|NCT04453800|Drug|Sofadil|750mg Intravenous infusion of sofadil starting at 500mg was 500ml，followed by nine intravenous infusions, each 500mg infusion with 250ml sofadil for 5 days, and each interval is 12 hours
15799659|NCT04453800|Drug|Sofadil|1500mg Intravenous infusion of sofadil starting at 500mg was 500ml，followed by nine intravenous infusions, each 500mg infusion with 250ml sofadil for 5 days, and each interval is 12 hours
15799660|NCT04453800|Other|placebo|Saline was administered intravenously
15799661|NCT04453787|Other|Arch support orthoses with forefoot medial wedge|The degree of forefoot wedge will be 3 degree. If needed, it could be adjusted. The subjects need to wear the orthoses for at least 30 hour per week during the experiment.
15799662|NCT04453787|Other|Arch support orthoses|The arch support of the orthoses could be adjusted depends on the evaluation of subject. The subjects need to wear the orthoses for at least 30 hour per week during the experiment.
15799663|NCT04453787|Other|Flat insole|The flat insole used as a placebo intervention. The shape of this insole is flat, and made by soft EVA. It only provide shock absorbtion without any support. The subjects need to wear the orthoses for at least 30 hour per week during the experiment.
15799664|NCT04453774|Device|Covidfree@home|Mobile phone, Covidfree@home app, thermometer, pulse oximeter, smart watch
15799665|NCT04453761|Drug|Neurobion|Intravenous Thiamine 2 mg/kg in Neurobion injection
15799666|NCT04453761|Drug|Placebo|Intravenous NaCl0.9%
15799667|NCT04453748|Other|Complex diagnostic panel|Complex, multidisciplinary diagnostic panel, including blood, imaging and functional tests.
15799668|NCT04453735|Drug|Atorvastatin mylan 40 Mg Oral Tablet|Oral tablet on regular prescription
15799669|NCT04453722|Device|Oxalert Monitor|The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO. Using the Oxalert in monitor only mode.
15799670|NCT04453722|Device|Oxalert Monitor|The investigator will evaluate the feasibility of a fully randomized validation trial for the Oxalert EPO using the Oxalert in monitor in normal mode
15799671|NCT04453709|Behavioral|Problem Management Plus for Immigrants at family settings|"PMP-I is a 5-week, peer-led, culturally tailored psychoeducation, behavioral activation (90 minutes), breathing and yoga intervention (90 minutes) in a family setting. PMP-I will use a structured approach, including once a week face-to-face sessions, breathing and yoga practices.
~Managing Stress: Breathing and yoga practices, stress-management sessions, and behavioral activation exercises to strengthen positive coping strategies.
~Managing Problems: Practice exercises to identify the problems, develop solutions, and plan a strategy to carry out those solutions.
~Get Going, Keep Doing: Communication skill sessions and practice exercises to identify and carry out pleasant tasks.
~Strengthening Social Support: Social skills session and practice exercise to identify social support.
~Staying Well: Make a plan that helps to create supportive family environment."
15799672|NCT04453709|Behavioral|Talk program with Community Support Service Pamphlet (CSS)|Pamphlet including list of community support service institutions
15799673|NCT04453696|Behavioral|Assessment scales-the Spielberger's State-Trait Anxiety Inventory, Modified Dental Anxiety Scale and a visual analog scale.|"STAI-S, like kinetic energy, refers to a palpable reaction or process taking place at a given time and level of intensity. STAI-T, like potential energy, refers to individual differences in reactions. Both of STAI-S and STAI-T scales includes 20 questions. For each question, the scores range from 1 (almost never) to 4 (almost always) points. For both scales, the sum of the scores ranges from 20 to 80. A score between 36 and 41 refers to a mean anxiety level, with values greater than 41 classified as a high level of anxiety.
~The MDAS consists of 5 questions that measure anxiety at different stages of dental treatment. The options range from 1 (not anxious) to 5 (very anxious) for each question. The sum of the scores varies from 5 to 25; values between 19 and 25 indicate a high level of dental anxiety.
~The VAS scale was included in the present study to determine how anxious the patients felt according to their own thoughts. Scores range from 0 (no anxiety) to 10 (extreme anxiety)."
15799674|NCT04453683|Device|Air-Q. ILA insertion of proper size|Success of fiberoptic guided intubation throuhgh Air Q supraglottic airway device
15799675|NCT04453683|Device|ILMA insertion of proper size|Success of fiberoptic guided intubation throuhgh ILMA supraglottic airway device
15799676|NCT04453670|Procedure|autopsy|autopsy
15799677|NCT04453657|Device|FamilyChildCare (provisional name of app)|Parents will provide their child(ren) access to a smartphone, tablet, or computer for approximately 30 minutes, three times per week for 15 weeks with a total dosage of instruction of about 22.5 hours. Parents and providers will receive self-care, parenting, and parent engagement tips and resources through push notifications twice a day. Additionally, daily reminders will be sent to parents through push notification to give their child(ren) access to the learning games. After 15 weeks of app engagement, the providers and parents will be contacted by the PI to notify them of the 15 week time mark and provide the information for post-surveys via Qualtrics.
15799678|NCT04453644|Other|Muscle static stretching|On day-I: Static Stretching done for 2 minutes (SS2), on day-II: Static Stretching done for 4 minutes (SS4), and on day-III: Static Stretching done for 8 minutes (SS8).
15799679|NCT04453631|Device|active tDCS|26 transcranial direct current stimulation sessions, each lasting 20 minutes, with a current intensity of 2 mA, the cathode placed over the right dorsolateral prefrontal cortex and the anode placed over the left deltoid muscle.
15799680|NCT04453631|Device|sham tDCS|tDCS is controlled in this intervention: sham mode.
15799913|NCT04451863|Drug|High THC|Vaporized THC (15 mg)
15799681|NCT04453631|Behavioral|CBT-UP|15 psychotherapy sessions (1/week) following the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders developed by Barlow et al. 2018.
15799682|NCT04453631|Behavioral|Psychoeducation|To control for the cognitive-behavioral intervention we will use psychoeducation materials.
15799683|NCT04453618|Drug|FE-SYHA1402 100mg|in either a fasted state or with a meal
15799684|NCT04453618|Drug|SYHA1402-25mg|SYHA1402 25mg, oral tablets
15799685|NCT04453618|Drug|Placebo-25mg|Matching placebo tablets
15799686|NCT04453618|Drug|SYHA1402-50mg|SYHA1402 50mg, oral tablets
15799687|NCT04453618|Drug|Placebo-50mg|Matching placebo tablets
15799688|NCT04453618|Drug|SYHA1402-150mg|SYHA1402 150mg, oral tablets
15799689|NCT04453618|Drug|Placebo-150mg|Matching placebo tablets
15799690|NCT04453605|Other|standard treatments|patients were treated according to the good clinical practice recommended by the international guidelines, and followed a six-month or an yearly calendar of follow-up visits
15799691|NCT04453592|Other|No intervention assigned as part of this study.|"The intervention included in this study is part of routine medical care, and not assigned as a result of study participation. This study includes only the addition of a measurement; the bent knee fall out test. Therefore, we believe this study design is observational, and in line with the provided observation study design definition: Observational: studies in human beings in which biomedical and/or health outcomes are assessed in predefined groups of individuals. Participants in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the study participants. This includes when participants receive interventions as part of routine medical care, and a researcher studies the effect of the intervention.
~See uploaded study protocol for further details."
15799692|NCT04453579|Behavioral|Telephonic interview during the Italian lockdown.|The interview was composed of socio-demographic items lockdown, and dichotomous questions about physical and mental health in relation to the COVID-19 emergency
15799693|NCT04453566|Other|Online Survey|Online Survey
15799694|NCT04453553|Diagnostic Test|Q16 testing|Nasal swab tested on a rapid near patient device
15799695|NCT04453553|Diagnostic Test|Nasopharyngeal swab and main laboratory|Standard of care testing
15799696|NCT04453540|Diagnostic Test|FilmArray PCR on respiratory samples|Molecular test performed on respiratory samples realized for microbiological routine testing as part of the care
15799697|NCT04453514|Behavioral|Trauma-informed yoga video recording|Pre-recorded video of a 45-minute trauma-informed yoga practice. The yoga practice can be done standing or sitting in a chair. The yoga practice is comprised of slow, gentle movements combined with paying attention to the body and the breath. The practice uses invitational language and encourages participants to make choices and customize the movements according to their individual needs.
15799698|NCT04453501|Drug|favorable outcome|Whether patient under such regimen had a favorable outcome (no transfer in intensive care unit or death)
15799699|NCT04453488|Biological|RUTI® vaccine|Each dose of the RUTI® vaccine contains 25 µg of fragmented, purified and liposomed heat-inactivated Mycobacterium tuberculosis bacilli.
15799700|NCT04453488|Biological|Placebo|Physiological serum, 0.9% NaCl, will be used as a placebo
15799701|NCT04453475|Behavioral|Training session adressing information and health literacy|The training sessions are provided online and as alternative to face-to-face treatments which cannot be provided as before due to the safety regulations relating to Covid-19
15799702|NCT04453462|Procedure|Endoscopic carpal tunnel release under local direct median nerve block|local direct median nerve block is done by surgeon with 1%xylocaine with adrenaline 12 mL(5 mL subcutaneous at incision site and 7 mL over median nerve) (maximum dose 7 mg/kg) before endoscopic carpal tunnel release(1-portal Agee technique)
15799703|NCT04453462|Procedure|Endoscopic carpal tunnel release under brachial plexus block|brachial plexus block under ultrasound-guided by single anesthesiologist with 1%xylocaine with adrenaline 15 mL (maximum dose 7 mg/kg) before endoscopic carpal tunnel release(1-portal Agee technique)
15799704|NCT04453449|Drug|Midazolam|Midazolam given as a sedative during diagnostic lumbar medial branch block
15799705|NCT04453436|Drug|Tenofovir Disoproxil|Genotipic resistance test
15799706|NCT04453423|Drug|Anlotinib + Pemetrexed+Carboplatin|"Anlotinib: 12mg, QD, PO, d1-14, 21 days per cycle
~Carboplatin: AUC 5 on day 1 of 21 days per cycle
~Pemetrexed: 500mg/m2 iv on day 1 of 21 days per cycle"
15799707|NCT04453423|Drug|Pemetrexed|500mg/m2 iv on day 1 of 21 days per cycle(maintenance phase)
15799708|NCT04453423|Drug|Anlotinib + Pemetrexed|"Anlotinib:12mg, QD, PO, d1-14, 21 days per cycle(maintenance phase)
~Pemetrexed:500mg/m2 iv on day 1 of 21 days per cycle(maintenance phase)"
15799709|NCT04453423|Drug|Anlotinib|12mg, QD, PO, d1-14, 21 days per cycle(maintenance phase)
15799710|NCT04453410|Other|Questionnaire Quality-of-recovery 15 (QoR-15)|Children will use the questionnaire Quality-of-recovery 15 (QoR-15)
15799711|NCT04453397|Drug|TNB-383B|TNB-383B is a bispecific antibody targeting BCMA on tumor cells and CD3 on T-cells.
15799712|NCT04453384|Drug|XAV-19|Phase 2a: Administration on Day 1 and day 5 for Group1 and 2, Administration on Day 1 for Group 3 Phase 2b: Administration on Day 1
15799713|NCT04453384|Drug|Placebo|Phase 2a: Administration on Day 1 and day 5 for Group1 and 2, Administration on Day 1 for Group 3 Phase 2b: Administration on Day 1
15799714|NCT04453371|Drug|Tissue plasminogen activator|"In the study group, tPA (Alteplase) 25 mg i/v over 2 hours, followed by a 25 mg tPA infusion over the subsequent 22 hours. After the end of thrombolytic therapy, unfractionated heparin is administered i/v at a starting dose of 10 units / kg per hour. The target value of PTT is 40C-50C.
~In both groups patient's transfer from the heparin infusion to the introduction of low-molecular-weight heparins is performed after normalization of the D-dimer level."
15799715|NCT04453371|Drug|Ringer solution|"In the control group, an equivalent amount of Ringer's solution is administered. After 24 hours, the heparin infusion gets started, similar the described for study group.
~In both groups patient's transfer from the heparin infusion to the introduction of low-molecular-weight heparins is performed after normalization of the D-dimer level."
15799716|NCT04453358|Device|InCourage-Connect|This intervention will provide patients with clearly stated treatment goals and provide them with interactive feedback based on usage date to help support airway clearance therapy adherence.
15799717|NCT04453358|Device|InCourage|This intervention will provide standard of care airway clearance therapy with no interactive feedback on treatment goals and usage.
15799718|NCT04453345|Drug|thalidomide + prednisone + methotrexate|thalidomide 50-100mg daily at bedtime + prednisone 0.5mg/kg qod to 1mg/kg qd + methotrexate 10mg/m2 per week. 4 months one cycle, up to 3 cycles. After get partial remission, thalidomide maintenance will continue up to 2 years.
15799719|NCT04453332|Drug|Oral hormone therapy (estradiol and micronized natural progesterone)|Oral hormone therapy - estradiol 1mg every day and micronized natural progesterone 200mg only 14 days a month
15799720|NCT04453332|Drug|Non-oral hormone therapy (estradiol and micronized natural progesterone)|Percutaneous estradiol gel 1.5mg every day and micronized progesterone 200mg vaginal only 14 days a month
15799721|NCT04453319|Procedure|Femoral Wound Closure and dressing|Femoral Wound Closure and dressing
15799722|NCT04453306|Drug|Topiramate|topiramate 25mg is coated in tablets in an independent laboratory
15799723|NCT04453306|Drug|Placebo|innocuous substance is coated in tablets in an independent laboratory
15799724|NCT04453293|Biological|BCG (Tokyo 172) vaccine|Freeze-Dried Glutamate Bacillus Calmette-Guérin BCG Vaccine (Japan BCG Laboratory), 0.1 mL given as single dose by intradermal injection over the outer lower aspect of the deltoid region
15799725|NCT04453293|Drug|Placebo|Placebo vaccine diluent, 0.1 mL given as single dose by intradermal injection over the outer lower aspect of the deltoid region
15799726|NCT04453280|Diagnostic Test|Quantitative analysis of anti-SARS-CoV-2-antibodies|Plasma sampling will be collected and archived for subsequent quantitative analysis of anti-SARS-CoV-2 antibodies - IgG, IgM and IgA.
15799727|NCT04453280|Diagnostic Test|SARS-CoV-2 diagnostic rapid test|The rapid test detects the presence of antibodies against SARS-CoV-2 by the immunochromatographic reaction.
15799728|NCT04453254|Other|Whole Food Meal|Isocaloric/ macronutrient whole food meal
15799729|NCT04453254|Other|Supplement Food Meal|Isocaloric/ macronutrient supplement food meal
15799730|NCT04453241|Biological|NBP615|Intramuscular injection, 0.5ml
15799731|NCT04453241|Biological|Gardasil|Intramuscular injection, 0.5ml
15799732|NCT04453228|Other|Classification statistics|We classified skiers in the two snow seasons by injury site, type of injury, cause of injury, etc
15799733|NCT04453215|Device|dental implant|Dental implant placement
15799734|NCT04453202|Biological|RSV Vaccine|Participants will receive a single IM injection of an Ad26-based RSV vaccine on Day 1.
15799735|NCT04453202|Other|Placebo|Participants will receive a single IM injection of placebo on Day 1.
15799736|NCT04453189|Drug|JNJ-64417184|Participants will receive single dose of JNJ-64417184 in fed condition on Day 1 in assigned treatment sequence.
15799737|NCT04453189|Drug|Lansoprazole|Participants will receive lansoprazole once daily in fasted condition on Day 1 to 4 under fasted condition and 2 hours before single dose of JNJ-64417184 in fed condition on Day 5 in assigned treatment sequence.
15799738|NCT04453189|Drug|Famotidine|Participant will receive famotidine in fasted condition on Day 1 in assigned treatment sequence.
15799739|NCT04453176|Other|Patient Satisfaction|Patient satisfaction evaluated with EVAN G questionnaire
15799740|NCT04453163|Procedure|Vertebroplasty|Patient will undergo a surgery in percutaneous vertebroplasty
15799741|NCT04453150|Other|Standard hypocaloric die|Standard hypocaloric diet
15799742|NCT04453150|Other|Intermittent fasting 16/8 (early fasting)|Intermittent fasting 16/8 (early fasting)
15799743|NCT04453150|Other|Intermittent fasting 16/8 (late fasting)|Intermittent fasting 16/8 (late fasting)
15799744|NCT04453150|Other|Alternate-day fasting|Alternate-day fasting
15799745|NCT04453150|Other|Ketogenic diet|Ketogenic diet
15799746|NCT04453137|Biological|Adalimumab originator|Subcutaneous injection every other week
15799747|NCT04453137|Biological|Adalimumab biosimilar|Subcutaneous injection every other week
15799748|NCT04453124|Biological|Topical antiseptic treatment|Prevent the development of bacterial cutaneous ulcers by applying antiseptic sap from Ficus septica tree on small wounds.
15799749|NCT04453111|Biological|Placenta-derived MMSCs|Cryopreserved placenta-derived multipotent mesenchymal stem / stromal cells
15799750|NCT04453111|Biological|Bone marrow-derived MMSCs|Cryopreserved bone marrow-derived multipotent mesenchymal stem / stromal cells
15799751|NCT04453111|Drug|Hyalgan 20 mg in 2 ML Prefilled Syringe|Hyaluronic Acid 20 mg
15799752|NCT04453098|Behavioral|3-week residential program based on a tryptic (diet,|"3-week residential program based on a tryptic (diet, exercise, education). The three weeks intervention was followed by a 1-year at-home follow-up.
~In the original protocol, participants were involved in a 3-week residential program based on a tryptic (diet, exercise, education)."
15799753|NCT04453085|Drug|JR-171|JR-171 IV infusion
15799754|NCT04453072|Other|Interview|Participate in interviews
15799755|NCT04453072|Other|Media Intervention|Receive iPhone with W8Loss2Go app
15799756|NCT04453072|Other|Questionnaire Administration|Complete questionnaires
15799757|NCT04453072|Other|Scale Device|Receive body scale and food scale
15799758|NCT04453072|Behavioral|Telephone-Based Intervention|Receive telephone calls
15799759|NCT04453072|Other|Text Message|Receive text message
15799760|NCT04453059|Drug|Iopamidol|Previously administered Isovue-300 (300 mgI/mL) PO at a dilution of 2-3% (6-9 mgI/mL)
15799761|NCT04453046|Device|Hemopurifier|Two Hemopurifier treatments on Day 1 and Day 21
15799762|NCT04453046|Drug|Pembrolizumab 200mg IV|Pembrolizumab 200mg IV will be administered every 21 days. One cycle is 21 days. All patients will be treated with Pembrolizumab for up to 34 cycles
15799763|NCT04453033|Device|Celeste Specialized Phototherapy Device|Ocular phototherapy light panel
15799764|NCT04453020|Device|DBS of the LHA|Deep Brain Stimulation of the Lateral Hypothalamic Area
15799914|NCT04451863|Drug|Low Myrcene|Vaporized Myrcene (0.5 mg)
15799767|NCT04452994|Drug|JNJ-68284528|JNJ-68284528 will be administered as a single intravenous (IV). The target dose will be the recommended Phase 2 dose (RP2D) of 0.75*10^6 chimeric antigen receptor (CAR)-positive viable T cells per kilogram (cells/kg) (range: 0.5 to 1.0*10^6 CAR-positive viable T cells/kg).
15799768|NCT04452981|Device|VeNS|The VeNS device utilizes a technology called galvanic vestibular stimulation (GVS) (sometimes termed vestibular nerve stimulation (VeNS)). The device will be placed on the head in a manner analogous to headphones and will deliver a small electrical current to the skin behind the ears, over the mastoid processes. Participants will be advised to use the device at home for 1 hour per day.
15799769|NCT04452968|Behavioral|intermittent fasting|Women were required to fast for 16 hours and consume their allotted calories during the remaining 8 hours.
15799770|NCT04452968|Behavioral|Caloric restriction|Daily caloric requirement was calculated using basal metabolic rate (BMR) calculator. All women were directed to decrease calorie intake by 500 calories.
15799772|NCT04452929|Drug|Erenumab|Subcutaneous injection of 140 mg erenumab.
15799773|NCT04452929|Drug|Placebo|Subcutaneous injection of saline placebo.
15799774|NCT04452929|Drug|Calcitonin gene-related peptide|Intravenous infusion of 1.5ug/min calcitonin gene-related peptide over 20 minutes.
15799775|NCT04452929|Drug|Cilostazol|Oral intake of 200 mg cilostazol.
15799776|NCT04452916|Other|Buchinger fasting|Caloric intake of < 250 kcal/d for 5 days
15799777|NCT04452903|Behavioral|communication skills|3-hour communication skill workshop, followed by a month-long period to assimilate and implement the new set of skills, with supervision available by phone from the trainers.
15799778|NCT04452890|Diagnostic Test|Sonourethrography|Ultrasound of the urethra.
15799779|NCT04452877|Drug|Dabrafenib|Dabrafenib will be provided by the sponsor to the investigative site or supplied locally as commercially available. Dabrafenib will be administered orally twice daily (150 mg BID) for Days 1-21 of a 21-day cycle.
15799780|NCT04452877|Drug|Trametinib|Trametinib will be provided by the sponsor to the investigative site or supplied locally as commercially available. Trametinib will be administered orally once daily (2 mg QD) for Days 1-21 of a 21-day cycle
15799781|NCT04452864|Device|Computerized Cognitive Training|The study intervention consists of a tablet-based cognitive training, targeting the cognitive domains mostly affected by Alzheimer Disease.
15799782|NCT04452864|Device|Documentaries with delayed Computerized Cognitive Training|The active control group watches documentaries for three months before starting with the CCT.
15799783|NCT04452851|Device|BREATHE|The on-demand handheld portable noninvasive positive pressure airway device unit generates BiPAP by using a built-in blower which intakes air from the nearby ambient. The BiPAP pressure functions as a virtual stent within the lungs of a user with COPD. The virtual stent opens the passageways within the user lungs. Once opened, the virtual stent facilitates gas exchange in order to relieve dyspnea. By temporarily facilitating this gas exchange, the user will quickly recover from dyspnea in order to resume regular activities.
15799784|NCT04452851|Device|BiPAP|BiPAP stands for Bilevel Positive Airway Pressure, and is very similar in function and design to a CPAP machine (continuous positive airway pressure). A BiPAP machine is a non-invasive form of therapy for patients suffering from sleep apnea.
15799785|NCT04452851|Drug|COPD Inhaler|Inhaler medication to support quick relief from COPD symptoms
15799786|NCT04452838|Drug|Fesoterodine BIC SR4 fasted (Treatment A in Part A, Treatment G in Part B)|4 mg administered under fasted condition.
15799787|NCT04452838|Drug|Fesoterodine BIC SR7 fasted (Treatment B in Part A, Treatment H in Part B)|4 mg administered under fasted conditions.
15799788|NCT04452838|Drug|Fesoterodine BIC SR7 fed (Treatment C in Part A, Treatment F in Part B)|4 mg administered under fed conditions.
15799789|NCT04452838|Drug|Fesoterodine BIC SR7 on apple sauce (Treatment D in Part A)|4 mg sprinkled on apple sauce administered under fasting conditions
15799790|NCT04452838|Drug|Fesoterodine BIC SR4 fed (Treatment E in Part B)|4 mg administered under fed conditions
15799791|NCT04452825|Behavioral|Cancer and Aging: Reflections for Elders (CARE) Intervention|For full participants (not training case participants) five sessions (45-60 minutes each) will be delivered over an 8-week period (+4 weeks). Following these sessions, four brief booster sessions (20-30 minutes each) will be delivered at a rate of approximately one per month to extend the interventions to 6 months (+3 months).
15799792|NCT04452825|Behavioral|Social Work and Supportive Counseling (SWSC) Intervention|The SWSC will include a social work assessment and follow-up augmented with additional components of supportive psychotherapy that have been shown to be an effective form of treatment for patients with cancer. For full participants (not training case participants) five sessions (45-60 minutes each) will be delivered over an 8-week period (+4 weeks). Following these sessions, four brief booster sessions (20-30 minutes each) will be delivered at a rate of approximately one per month to extend the interventions to 6 months (+3 months). Training case participants will follow a slightly condensed schedule.
15799793|NCT04452812|Biological|Convalescent plasma|"Best available treatment + convalescent plasma
~Best available treatment: hemodynamic support, oxygen supplementation, antibiotic therapy (if required), and individualized treatment judged by the attending physician.
~Plasma will be split by aliquots of 200 ml for its storage on -60 celsius degrees until it's used. After defrosting, it will be administered on 2 200 ml separated doses on a 12 hours interval."
15799794|NCT04452799|Drug|Hesperidin and Diosmin mixture|Interventional Clinical Trial
15799795|NCT04452786|Procedure|Endoscopic sleeve gastroplasty|Four-hour solid mixed meal test
15799796|NCT04452786|Procedure|Laparoscopic sleeve gastrectomy|Four-hour solid mixed meal test
15799797|NCT04452773|Dietary Supplement|Manremyc|Manremyc is composed by 10E5 heat-inactivated Mycobacterium s. manresensis bacilli
15799798|NCT04452773|Dietary Supplement|Placebo|Same excipients than active arm without bacilli.
15799799|NCT04452760|Other|Physical exercise|Physical exercise intervention
15799800|NCT04452760|Other|Testing sessions|Testing sessions
15799801|NCT04452747|Procedure|Vaginal Dinoprostone system (Propess®)|Labour will be induced using the vaginal Dinoprostone system (Propess®) as a first strategy
15799802|NCT04452747|Procedure|Dilatation balloon|Labour will be induced using a cervix dilatation balloon as a first strategy
15799803|NCT04452734|Procedure|Platelet Rich Plasma (PRP)|PRP was prepared by withdrawing 8-10 ml of patients own blood (IV from antecubiodal area and collected in a vacuum tube coated with anticoagulant (Na citrate). For activation 1 ml of calcium chloride was added to Platelet Rich Plasma. This layer of approximately 2 ml of PRP was then taken into the residual bone cavity along with gel sponge to stimulate regeneration in wound healing after surgical extraction of mandibular third molar tooth followed by sutures
15799804|NCT04452734|Procedure|Surgical Extraction|Surgical extraction procedure under Local anesthesia on dental chair, followed by spongstone (gel sponge) and suture placement.
15799805|NCT04452721|Other|dynamic compression system|It is a harness that the patient wears all day long for an average duration of 1 year, and that remodels the chest by exerting a moderate pressure on it
15799806|NCT04452708|Device|HFNC|HFNV vs NIV vs conventional nasal cannula
15799807|NCT04452695|Device|Doctor Spot|Robotic platform (Boston Dynamics) controlled by clinician with video interface to facilitate telemedicine triage
15799808|NCT04452682|Other|COVID 19 impact|The impact of COVID-19 pandemic on Critical limb threatening ischemia and emergency vascular practice
15799809|NCT04452669|Drug|VentaProst (inhaled epoprostenol delivered via a dedicated delivery system)|VentaProst delivered for up to 10 days via mechanical ventilation at a dose range that may be up or down titrated to a patient's clinical condition.
15799810|NCT04452656|Procedure|bilateral erector spinae block|"An ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T3 spinous process corresponding to the T2 transverse process.
~Three muscles; trapezius , rhomboids major , and erector spinae will be identified superior to the hyperechoic transverse process.
~Using in-plane approach a 25 G needle will be inserted in caudal-cephalad direction, until the tip is deep to erector spinae muscle.
~Correct needle tip location will be confirmed by injecting 3 mL of saline and visualizing the linear LA spread in the fascial plane between the erector spinae muscle and the transverse process..
~0.4 ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%) will be injected and visualizing the linear LA spread in the fascial plane between the erector spinae muscle andthe transverse process12."
15799811|NCT04452643|Biological|BACMUNE (MV130)|BACMUNE (MV130) is a bacterial preparation that contains a mixture of Gram + and Gram - inactivated bacteria at the concentration of 300 FTU / mL (approx. 10^9 bacteria / mL)
15799812|NCT04452643|Other|Placebo|Placebo is a solution on sodium chloride at 0.9%
15799813|NCT04452630|Other|Infectious Disease and Cardiology Clinical Consultations|Infectious Diseases and Cardiology Clinical Consultations at 1 month and 12 months of recovery from an episode of Covid-19
15799814|NCT04452591|Biological|CG0070|Engineered Oncolytic Adenovirus
15799815|NCT04452591|Other|n-dodecyl-B-D-maltoside|Transduction-enhancing agent.
15799816|NCT04452578|Procedure|Procedure: Heart Transplantation|A HCV negative or previously successfully treated recipient who recieves a HCV positive graft will be monitored. Patients who recieve an HCV graft will be treated for HCV according to accepted protocols.
15799817|NCT04452565|Drug|Drug: NA-831|NA-831 is a neuroprotective drug, available at 30 mg capsule
15799818|NCT04452565|Combination Product|NA-831 and Atazanavir|"Drug: NA-831 Neuroprotective drug Other Name: Traneurocin 30 mg capsule
~Drug: Atazanavir Sulfate Antiviral drug Other Name: Atazanavir Sulfate 200 mg tablet"
15799819|NCT04452565|Combination Product|NA-831and Dexamethasone|"Drug: NA-831 Neuroprotective drug Other Name: Traneurocin 30 mg capsule
~Drug: Dexamethasone anti-inflammatory drug Other Name: Dexamethasone 4 mg"
15799820|NCT04452565|Combination Product|Atazanavir and Dexamethasone|Drug: Atazanavir Sulfate Antiviral drug Other Name: Atazanavir Sulfate 200 mg tablet Drug: Dexamethasone anti-inflammatory drug Other Name: Dexamethasone 4 mg
15799821|NCT04452552|Other|healthy diet|balanced diet program which ranged from 1600 kcal to 2000 kcal/day, which was calculated in an individual basis for each woman according to her basal metabolic rate (BMR) for 8 weeks
15799822|NCT04452539|Procedure|Paediatric cardiac surgery|All patients undergoing paediatric cardiac surgery
15799823|NCT04452526|Other|Best Practice|Receive usual care
15799824|NCT04452526|Other|Educational Intervention|Receive educational materials
15799825|NCT04452526|Other|Questionnaire Administration|Ancillary studies
15799826|NCT04452526|Other|Reminder|Receive reminder letter
15799829|NCT04452487|Behavioral|decisions of limitations and stop processing|Compliance of the modalities of decisions of limitations and stop processing
15799830|NCT04452474|Drug|Olokizumab 64 mg|solution for subcutaneous administration 160 mg/mL
15799831|NCT04452474|Drug|Placebo|Normal Saline (0.9% Sodium Chloride solution for Injection), in the market package
15799832|NCT04452461|Drug|mFOLFIRINOX|mFOLFIRINOX, including: Oxaliplatin 85 mg/m2 IV over 2 hours, Leucovorin 400mg/m2 IV over 2 hours, Irinotecan at 150 mg/m2 IV over 90 min, 5-Fluoruracil continuous infusion of 2400 mg/m2 IV over 46h.
15799833|NCT04452461|Drug|Gemcitabine / Nab-paclitaxel|Both drugs are administered once weekly for three weeks (days 1, 8, 15) followed by a week of rest (28-day cycle) for 3 cycles prior to imaging. Gemcitabine: 1000 mg/m2 intravenous infusion over 30 to 40 minutes. Nab-paclitaxel: 125 mg/m2 intravenous infusion over 30 to 40 minutes.
15799834|NCT04452461|Radiation|Stereotactic body radiation therapy|"The radiation dose will be limited to 30 Gy maximum for the small bowel. For other organs, we will follow the as low as reasonably achievable principle. Radiation quality assurance will be performed for all treatment plans. Volumes of tumour obtained on CT images at 1.25 mm slice thickness will be reconstructed into a three-dimensional image set for SBRT planning. The SBRT will deliver a radiation dose of 36 Gy in three fractions with 12 Gy per fraction to the isodose line best encompassing the planning target volume, including a 2 mm expansion around the gross tumour."
15799835|NCT04452448|Device|LASIK|All cases were operated upon using Wavelight Allegretto EX-500 excimer laser (Alcon Laboratories, Inc., Fort Worth, TX) with wave front optimized ablation profile WFO. The Moria II microkeratome (Moria, Anthony, France) was used in all cases.
15799836|NCT04452435|Drug|C21|C21
15799837|NCT04452435|Drug|Placebo|Placebo
15799838|NCT04452409|Device|low level laser|The laser therapy device (660 nm) consisted of abdominal straps containing 4 LED clusters, having 72 LEDs each, applied in the study group paticipants around the patients abdomen and waist after cleaning the target area and wearing safety goggles20, for 30 min., 2 times per week over 12 weeks
15799839|NCT04452409|Other|Mediterranean diet|recommend healthy diet component evaluated periodically by 24 hour recall
15799840|NCT04452396|Device|use of continuous glucose monitoring|Patients will wear a CGM device whilst undergoing diagnostic testing for reactive/spontaneous hypoglycaemia and then optimisation of anti-hypoglycaemic medication.
15799841|NCT04452383|Drug|Ketamine + propofol|effect of adding ketamine to propofol for patients undergoing DISE surgery
15799842|NCT04452383|Drug|propofol|effect of IV propofol alone for patients undergoing DISE surgery
15799843|NCT04452370|Drug|oral etoposide + anlotinib|anlotinib 12mg qd, d1-14，21days/cycle oral etoposide 75mg qd，d1-10，21days/cycle
15799844|NCT04452357|Radiation|PLDR|"PLDR radiation will be delivered as 10 fractions of 20 cGy, initiated once every 3 minutes. Dose levels will be selected as follows:
~Dose level 1: 56 Gy; Dose level 2: 66 Gy Drug: Gemcitabine"
15799845|NCT04452344|Drug|opioid-containing analgesic|hydrocodone/ acetaminophen combination product
15799846|NCT04452344|Drug|two over-the-counter analgesics|combination of over-the-counter analgesics (ibuprofen/acetaminophen)
15799847|NCT04452331|Other|Open Access Audio|Patient obtains secure access to an audio recording of the medical encounter post-visit that is accessible from any internet enabled device.
15799848|NCT04452331|Other|No Access, Patient and Provider Aware of Recording|Patient does not obtain access to audio recording but both patient and provider are aware visit is being recorded.
15799849|NCT04452331|Other|No Access, Provider Unaware of Recording|Patient does not obtain access to audio recording and provider is unaware visit is being recorded.
15799850|NCT04452318|Drug|REGN10933 + REGN10987|Subcutaneous (SC) or Intramuscular (IM) injections
15799851|NCT04452318|Drug|Placebo|SC or IM injections
15799852|NCT04452305|Procedure|Spermatogonial Stem Cell Transplant and Testicular Tissue Grafting|Spermatogonial stem cell transplant and testicular tissue grafting is performed to produce sperm.
15799853|NCT04452292|Other|Treatment Specific for Non-Small Cell Carcinoma/Adenocarcinoma|Treatment assigned to targetable mutation. Or, for tumors that are by and large without any targetable mutation follow Large-Cell Neuroendocrine Carcinoma (NCCN) guideline-directed best front-line treatment for specific non-small cell carcinoma/adenocarcinoma.
15799854|NCT04452292|Other|Treatment for Small Cell Lung Cancer|Treatment assigned to a targetable mutation or the current standard-of-care regimen for the treatment of small cell lung cancer.
15799855|NCT04452279|Device|iStent or iStent inject implantation with concomitant cataract surgery|Standard phacoemulsification cataract surgery followed by ab interno implantation of either iStent or iStent inject trabecular micro-bypass stent(s). Preoperatively and at specified visits through 3 months postoperative, patients will complete evaluations of their ocular surface disease (specifically OSDI score, hyperemia, corneal/conjunctival staining, and tear break-up time).
15799856|NCT04452266|Other|questionnaire assesment|Each patient will to answer questions about their medical history.
15799857|NCT04452253|Dietary Supplement|PS128|PS128 belongs to Lactobacillus plantarum subsp. plantarumand. Probiotic capsules contain 10 billion CFU (colony forming units) of PS128
15799858|NCT04452253|Dietary Supplement|PS23 live|PS23 belongs to Lactobacillus paracasei group.Probiotic capsules contain 10 billion CFU (colony forming units) of PS23
15799859|NCT04452253|Dietary Supplement|PS23 heat-treated|The PS23 heat-treated probiotic capsule contain 10 billion of PS23 cells.
15799860|NCT04452253|Other|Placebo|The placebo capsule contains microcrystalline cellulose.
15799861|NCT04452240|Device|thoracic endovascular repair|Repair of thoracic aorta lesions with the application of a dedicatet stent-graft by endovascular way.
15799862|NCT04452227|Other|questionnaire|Filling the menstrual distress questionnaire, short-form McGill pain questionnaire, present pain index, visual analog scale
15799863|NCT04452214|Drug|CAN04|Administered intravenously
15799864|NCT04452214|Drug|Pembrolizumab|Administered intravenously
15799865|NCT04452201|Behavioral|Guided Participation|GP couples' participation together in development of communication competencies in the context of infant care will be supported by a handbook and telephone guidance structured for collaboration with the nurse/research assistant beginning at approximately 2 weeks of age. Two face-to-face sessions are expected prior to hospital discharge, followed by 5 or 6 monthly phone sessions. If the baby is inpatient at the time an intervention session is to take place, the session may be done face-to-face, if more convenient than a phone session for the parents.
15799866|NCT04452188|Other|Normoxia (with controlled re-oxygenation)|"Participants will receive lower levels of oxygen during surgery and after surgery on the ventilator.
~As cardiopulmonary bypass is being weaned, anesthesia will initiate mechanical ventilation with an FiO2 of 50% or less (unless clinically necessary) to achieve oxygen saturation and PaO2 goals that fit within the expected range for the patient's physiology:
~Single ventricle patients (PaO2:35-45 and oxygen saturation 75%-85%)
~Two ventricle patients (PaO2: 60-100 and oxygen saturation >92%)"
15799867|NCT04452188|Other|Standard of care ventilation|As cardiopulmonary bypass is being weaned, anesthesia will initiate mechanical ventilation per standard protocols. Ventilation will be continued in the ICU and adjusted per standard goals per the intensivist.
15799868|NCT04452175|Other|JUUL E-CIGARETTE|JUUL E-CIGARETTE USAGE FOR 24 WEEKS
15799869|NCT04452162|Diagnostic Test|MRI|You are being asked to complete one research MRI scan with and without contrast at least 24-48 hours after your clinical MRI/CT has shown the presence of a suspicious salivary gland tumor, prior to your scheduled upcoming surgery. MRI contrast agents act like a dye to make MRI pictures brighter and easier to read. During each MRI scan, you will have an intravenous line (IV line) placed. The IV line allows the contrast agent to be injected into your vein. A urine pregnancy test will be conducted for those of child bearing age to confirm eligibility for this study.
15799870|NCT04452149|Device|Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download|Reveal LINQ™ Insertable Cardiac Monitor with investigational ALLEVIATE-HF RAMware download.
15799871|NCT04452149|Other|Medication intervention|Risk status guided medication intervention.
15799915|NCT04451863|Drug|High Myrcene|Vaporized Myrcene (12.0 mg)
15799873|NCT04452123|Procedure|Laparoscopic argon plasma treatment of endometrioma|Laparoscopic Argon Plasma vaporising the endometriotic cyst lining only until haemosiderin pigment stained tissue is no longer visible
15799874|NCT04452123|Procedure|Laparoscopic stripping of endometrioma and suture/coagulation of the rest of ovary|Laparoscopic dissecting of capsule of endometrioma and achieving hemostasis with suture of rest of the ovary or with gentle coagulation.
15799875|NCT04452110|Diagnostic Test|Ultrasonography|Temporomandibular joint diseases of ultrasonography its effectiveness and reliability in diagnosis disadvantages in MR and other imaging methods be ruled out.
15799876|NCT04452097|Biological|Human umbilical cord mesenchymal stem cells + best supportive care|hUC-MSC product will be administered intravenously in addition to the standard of care treatment.
15799877|NCT04452097|Other|Placebo control + best supportive care|Placebo control will be administered intravenously in addition to the standard of care treatment.
15799878|NCT04452084|Radiation|HA-WBRT|The accepted standard HA-WBRT doses in the control arm are 30Gy in 10 fractions.
15799879|NCT04452084|Radiation|HA-SIB-WBRT|The doses selected for experimental HA-SIB-WBRT arm are 30Gy in 10 fractions to the whole brain with 40 to 45Gy in 10 fraction SIB doses to tumours.
15799880|NCT04452071|Radiation|periapical xray|periapical xray on the middle phalanax of the middle finger
15799881|NCT04452058|Other|Radiomic Algorithm|Different radiomic and machine learning strategies for radiomic features extraction, sorting features and model constriction
15799882|NCT04452045|Device|SweetDreams|SweetDreams is a mHealth adaptation of existing evidence-based sleep interventions. It is a user friendly and developmentally appropriate modularized 4-week web-based intervention available on computer, tablet or mobile phones.
15799883|NCT04452032|Procedure|Dental avulsion|Before radiotherapy, each subject undergoes a dental evaluation and if it is necessary, dental avulsions if their long-term survival is compromised (see in section 6.1.2) and if they are located in an area at risk to receive more than 40 Gy, so to develop osteoradionecrosis of the jaw. The avulsions should be performed as far as possible from the start of radiotherapy (RT) namely at least 2 weeks before irradiation to allow mucosal healing.
15799884|NCT04452032|Radiation|Radiotherapy|"Radiotherapy:
~All Subjects will be treated by simultaneous integrated boost (SIB) intensity modulated radiotherapy (IMRT) / volumetric modulated arc therapy (VMAT)."
15799885|NCT04452019|Device|Use of standard standing frame|-Two training sessions in a standard standing frame, max 30 min. pr. session
15799886|NCT04452019|Device|Use of a new device;Innowalk Pro|Two training sessions in Innowalk Pro, max 30 min pr. session
15799887|NCT04452006|Drug|ACT-541478 10 mg|ACT-541478 will be provided in HPMC capsules for oral administration at a dose strength of 10 mg.
15799888|NCT04452006|Drug|ACT-541478 30 mg|ACT-541478 will be provided in HPMC capsules for oral administration at a dose strength of 10 mg.
15799889|NCT04452006|Drug|ACT-541478 100 mg|ACT-541478 will be provided in HPMC capsules for oral administration at a dose strength of 50 mg.
15799890|NCT04452006|Drug|ACT-541478 300 mg|ACT-541478 will be provided in HPMC capsules for oral administration at dose strengths of 50 mg and 250 mg.
15799891|NCT04452006|Drug|ACT-541478 1000 mg|ACT-541478 will be provided in HPMC capsules for oral administration at a dose strength of 250 mg.
15799892|NCT04452006|Drug|ACT-541478 high or low dose (or placebo)|Cross-over design: ACT-541478 will be provided in HPMC capsules for oral administration at high or low dose strengths (to be defined after completion of Part A).
15799893|NCT04452006|Drug|ACT-541478 dose E1|E1 is a dose level that has been investigated and well tolerated in the adult dose level groups C1 to C3. ACT-541478 will be provided in HPMC capsules for oral administration at dose strengths of 10, 50, and 250 mg.
15799894|NCT04452006|Drug|Matching placebo|Matching placebo will be provided in HPMC capsules for oral administration.
15799895|NCT04451980|Procedure|Subcutaneous adipose tissue biopsy|Percutaneous adipose tissue biopsy
15799896|NCT04451980|Radiation|CT scan|CT scan of chest and abdomen without contrast
15799897|NCT04451980|Diagnostic Test|Oral glucose tolerance test|Ingestion of 75g of oral glucose syrup and measurement of blood glucose and insulin at time 0, 15 min, 30 min, 60 min, 90 min, and 120 min.
15799898|NCT04451980|Diagnostic Test|Blood collection|Fasting blood collection for plasma cytokines and T cell phenotypes.
15799899|NCT04451967|Procedure|thrombolysis|transfer after thrombolysis for STEMI patients within 6h since onset
15799906|NCT04451941|Device|Experimental: RecoveriX with individual EEG calibration|RecoveriX applied FES according to individual brainwave by individual EEG calibration for 5 times a week for 4 weeks
15799907|NCT04451941|Device|RecoveriX without individual EEG calibration|RecoveriX applied FES according to the brainwave of other subjects regardless of the individual brainwave for 5 times a week for 4 weeks
15799908|NCT04451928|Diagnostic Test|Serum sample analysis|Analysis of the levels of ischemia-modified albumin, biglycan and decorin levels
15799909|NCT04451915|Other|late management strategy|late management strategy of GDM defined as no intervention until GDM screening at 24-28 weeks. Between 24-28 weeks gestation, a 75-g OGTT will be done
15799910|NCT04451915|Other|early management strategy|early management of GDM defined as intensive metabolic treatment. Intensive treatment involved the following multidisciplinary approach: lifestyle defined by diet and exercise intervention according to the French guidelines
15799911|NCT04451889|Device|miniprobe Alveoflex|Alveoflex uses 488nm laser, generating real time moving images with an optical area of 600μm at a video frame rate of 12 images per second and a focus depth of 50μm
15799916|NCT04451863|Drug|Low Beta-Caryophyllene|Vaporized Beta-Caryophyllene (0.5 mg)
15799917|NCT04451863|Drug|High Beta-Caryophyllene|Vaporized Beta-Caryophyllene (7.5 mg)
15799918|NCT04451863|Drug|Placebo|Vaporized Placebo
15799919|NCT04451850|Other|Noninvasive actigraphy monitor|Noninvasive chest-mounted actigraphic device to be worn for 2 hour intervals two times per week during the six month study participation.
15799920|NCT04451837|Drug|Semaglutide|Ozempic s.c. once weekly for 6 months
15799921|NCT04451837|Drug|Dapagliflozin|Forxiga 10 mg p.o. once daily for 6 months
15799922|NCT04451824|Device|CL-100|Red Light LED device for circumferential reduction
15799923|NCT04451811|Drug|OPL-002|Spray dried dispersion and tablet formulation
15799924|NCT04451798|Device|Impella CP microaxial pump|ramp test
15799925|NCT04451785|Biological|blood sample|6 tubes of 4 milliliters (ml) maximum (total: 24 ml) will be sampled for the measurements of the different biological markers. In case of the genetic mutation is already known, only 5 tubes will be collected (total: 20 ml).
15799926|NCT04451785|Diagnostic Test|Pulse wave velocity|Non-invasive measurement of pulse wave velocity between the carotid and femoral arteries with piezo-electric sensors.
15799927|NCT04451772|Drug|Elsubrutinib|Oral; Capsule
15799928|NCT04451772|Drug|Placebo for Elsubrutinib|Oral; Capsule
15799929|NCT04451772|Drug|Upadacitinib|Oral; Tablet
15799930|NCT04451772|Drug|Placebo for Upadacitinib|Oral; Tablet
15799931|NCT04451759|Other|MRI exploration|ultra high field (7T) magnetic resonance imaging
15799932|NCT04451746|Drug|Combined Oral Contraceptive|The investigators consistently include patients who have been prescribed hormonal tablets for contraception, namely 1) COCs with bioidentical estrogen; 2) COCs with ethinyl estradiol 30mkg according to the scheme 21 + 7; 3) COCs with ethinyl estradiol 20mkg according to the scheme 21 + 7.
15799933|NCT04451733|Procedure|Endotracheal intubation|Perform the endotracheal intubation during CPR
15799934|NCT04451720|Drug|Risankizumab|Subcutaneous (SC) injection
15799935|NCT04451720|Drug|Placebo|Subcutaneous (SC) injection
15799936|NCT04451707|Other|non-cholera Vibrio infection|Epidemiology of patients diagnosed with non-cholera Vibrio infection
15799937|NCT04451694|Other|nutritional intervention|nutritional evaluation and intervention and orientation towards adapted care establishment
15799938|NCT04451681|Other|Cardiopulmonary exercise test|Data such as oxygen consumption, cardiac parameters and speed of the patient are analyzed numerically on the treadmill in the KPET; Objective performance values such as maximum oxygen use (VO2max), maximum heart rate, respiratory capacity, and maximum rate will be obtained.
15799939|NCT04451668|Drug|FT218|once nightly sodium oxybate extended release
15799940|NCT04451655|Drug|Continuous insulin infusion|This study aims to explore the hypothesis that diabetic patients undergoing coronary artery bypass graft (CABG) surgery receiving intravenous continuous insulin infusion (CII) for tight glycemic control (110-149 mg/dl) protocol during the intraoperative period would have improved intraoperative glycemic stability, efficacy and consistency compared to patients receiving conventional glycemic control (150-180 mg/dl) protocol during the intraoperative period
15799941|NCT04451642|Procedure|Peripheral nerve block|Peripheral nerve block consists of the administration of a local anaesthetic into the nerves to inhibit nerve transmission in a specific part of the body. Ultrasound or Nerve stimulator could be used to locate the peripheral nerve. A needle is placed through the anatomical references to administer local anaesthetic around the peripheral nerve. Single-shot or continuous blocks are performed preoperatively and postoperatively as current practice in the surgery theatre. Using ultrasound, in-plane or out-plane approach could be performed. Peripheral nerve block provides excellent intraoperative and postoperative analgesia decreasing the need for intravenous pain drugs. Interscalene block, supraclavicular block, safene block, femoral block, BRILMA block are different kinds of peripheral nerve block using in the anaesthestic current practice.
15799942|NCT04451629|Behavioral|pelvıc base exercıse, core exercise|Effectıveness of the pelvıc base exercıse on the paın and qualıty of lıfe ın dysmenoral youth 40 minutes exercise intervention 4 times a week for 8 weeks
15799943|NCT04451616|Diagnostic Test|Blood sample collection|Fasting blood sample will be collected from forearm vein. In the sample the concentration of: progranulin and serum FAM19A5 protein, leptin, VEGF, insulin, neopterin, adropin and selected cytokines, adipokines, myokines and chemokines, total cholesterol, low-density lipoproteins, high-density lipoproteins, triglycerides and glucose will be determined. Whole blood sample will be secured to isolate genetic material, detect and examine progranulin and FAM19A5 genes, and genes associated with the development of metabolic syndrome and with the body's mineral management. Serum mineral analysis will be performed.
15799944|NCT04451616|Diagnostic Test|Hair sample collection|Hair sample collection will be performed. Hair mineral analysis will be performed.
15799945|NCT04451616|Diagnostic Test|Urine sample collection|Urine sample collection will be performed. Urine mineral analysis will be performed.
15799946|NCT04451616|Diagnostic Test|Body composition analysis|Body composition analysis with the use of electric bioimpedance will be performed.
15799947|NCT04451616|Diagnostic Test|Questionnaires|Dietary and lifestyle interview with the use of dietary and lifestyle questionnaires and dietary diaries will be performed.
15799948|NCT04451616|Diagnostic Test|Blood pressure, pulse and blood oxygen saturation measurement|Blood pressure, pulse and blood oxygen saturation measurements with the use of non-invasive methods will be performed.
15799949|NCT04451603|Procedure|Surgery|Surgical resection of the liver
15799950|NCT04451603|Radiation|Radiation therapy|Y-90 radioembolization therapy is the main treatment
15799951|NCT04451603|Drug|Drug treatment|Examples include tyrosine kinase inhibitors and immune checkpoint inhibitors
15799977|NCT04451356|Diagnostic Test|Echocardiography|Echocardiographic evaluations will be made in each patient at baseline. All echocardiographic measurements will be carried out according to the recommendations of the American Society of Echocardiography by an observer unaware of the lung ultrasound and bioimpedance results. Echocardiographic evaluation will provide information about cardiac anatomy (e.g. volumes, geometry, mass) and function (e.g. left ventricular function and wall motion, valvular function, right ventricular function, pulmonary artery pressure, pericardium).
15799952|NCT04451590|Other|VR-based simulation|Participants will experience a novel interactive and immersive VR full size trauma bay with an adult patient and healthcare professionals. Immersed in the environment, learners undertake the decision-making steps in managing the medical care for a patient with an airway injury. Learners are first given the case scenario from which they form their own learning goals/plans. They then navigate through the scenario that will provide feedback depending on their actions in the form of either the patient's hemodynamic changes or prompts from healthcare avatars in the scenario. These feedback processes are built-in and designed to promote reflection and reorganization of the learner's decision-making strategies. As learning progresses, fewer prompts will be given. At the end of the scenario, evaluation algorithms pre-programmed into the VR-based simulation will be displayed.
15799953|NCT04451590|Other|Mannequin-based simulation|Participants will experience a mannequin-based scenario practice which is the current gold standard in medical education. The trauma airway management scenario will match the VR environment and sequence of events.
15799954|NCT04451577|Other|No intervention|No intervention, analysis of biological samples
15799955|NCT04451564|Behavioral|Mindfulness oriented recovery enhancement|8- week psychological program based on mindfulness techniques
15799956|NCT04451538|Dietary Supplement|Nutritional intervention group|Supplemental nutritional support is provided in addition to normal diet during the perioperative period (five days from pre- to postoperative phase). For non-diabetic patients, ENSURE is provided (Abbott; 112.6 g (12 spoons, 500 kcal)/day, twice a day); for diabetic patients, GLUCERNA SR is provided (Abbott; 104 g [12 spoons, 440 kcal]/day, twice a day).
15799957|NCT04451538|Dietary Supplement|Control group|Supplemental nutritional support is not provided in addition to normal diet during the perioperative period (five days from pre- to postoperative phase).
15799958|NCT04451525|Device|SOFIA® Flow Plus 6F Aspiration Catheter with the Gomco 405 Aspiration Pump and MicroVentionTubing Kit|Patient will be treated using the direct aspiration as first line treatment technique.
15799959|NCT04451499|Other|Smartphone app|The study specific smartphone app site will be based on current literature plus investigators experience and will include a wide knowledge on types of surgeries, dietary guidelines pre- and post-surgery, fluids type and amount, knowledge on supplementation use pre and post-surgery, general dietary knowledge, psychological information, physical activity, recommendation and tips for long-term surgery success, emphasis will be made on long-term follow-up meetings with the bariatric team and practical information on the preparation to the hospitalization process. The smartphone app site will contain video-based modules and encouraging messages. Patients will be encouraged to use the platform to ask questions and receive answers regarding any aspect of the surgery.
15799960|NCT04451486|Drug|SB cells|1x10*5 CD61-Lin- cells /0.25mL DPBS
15799961|NCT04451486|Drug|SB cells|1x10*6 CD61-Lin- cells /0.25mL DPBS
15799962|NCT04451486|Drug|SB cells|1x10*7 CD61-Lin- cells /0.25mL DPBS
15799963|NCT04451473|Procedure|Enhanced Recovery After Surgery (ERAS )|the treatment of procedure according to Guidelines for enhanced recovery after lung surgery: recommendations of the ERAS Society and the ESTS
15799964|NCT04451473|Procedure|Traditional perioperative management without Enhanced Recovery After Surgery (ERAS )|the treatment of procedure not abiding Guidelines for enhanced recovery after lung surgery
15799965|NCT04451447|Procedure|The White test uses fat emulsion (SMOFLIPID), for localization of bile leakage.|The White test uses fat emulsion (SMOFLIPID), which is a lipid emulsion with a lipid content of 0.2 grams/mL in 100 mL, 250 mL, and 500 Ml that is normally used for parenteral nutrition, for localization of bile leakage.
15799966|NCT04451447|Procedure|Saline test (routine test)|The conventional intra-operative saline test, which involves injecting an isotonic sodium chloride solution through the cystic duct, has been used for detection of leaking points from the transected liver surface.
15799967|NCT04451434|Drug|Danicopan|Oral tablet
15799968|NCT04451421|Behavioral|Change of standing Angle|Change the patient's standing Angle by using an electric bed
15799969|NCT04451408|Drug|LY3372993|Administered IV.
15799970|NCT04451408|Drug|Placebo|Administered IV.
15799971|NCT04451395|Dietary Supplement|Multiple micronutrients (UNIMMAP composition)|"The intervention is an oral tablet containing 15 different vitamins and minerals at the UNIMMAP composition (includes 30 mg iron, 400 μg folic acid, 15 mg zinc, 2 mg copper, 65 μg selenium, 800 μg RE vitamin A, 1.4 mg vitamin B1, 1.4 mg vitamin B2, 18 mg niacin, 1.9 mg vitamin B6, 2.6 μg vitamin B12, 70 mg vitamin C, 5 μg vitamin D, 10 mg vitamin E and 150 μg iodine). Each tablet is small (approximately 10 mm diameter) and has been procured using the UNICEF supply catalogue. A single MMN supplementation dose will consist of a single tablet.
~Other Name: UNICEF, Micronutrient tabs, pregnancy/PAC-1000"
15799972|NCT04451382|Biological|OnabotulinumtoxinA (BoNTA)|
15799973|NCT04451382|Procedure|Percutaneous tibial nerve stimulation (PTNS)|
15799974|NCT04451369|Other|Prehabilitation program|physical, nutritional and psycho-social supports before surgery
15799975|NCT04451356|Device|Bioimpedance Spectroscopy|This analysis will be performed at baseline using the portable whole-body multifrequency bioimpedance analysis device (BCM®Body Composition Monitor - Fresenius Medical Care D GmbH). The technique involves attaching electrodes to the patient's forearm and ipsilateral ankle, with the patient in a supine position. The BCM® measures the body resistance and reactance to electrical currents of 50 discrete frequencies, ranging between 5 and 1000 kHz. Based on a fluid model using these resistances, the extracellular water (ECW), the intracellular water (ICW) and the total body water (TBW) are calculated. These volumes are then used to determine the amount of fluid overload. All calculations are automatically performed by the software of the BCM® device. In addition, this analysis will provide the LTI and FTI for the included patients.
15799976|NCT04451356|Device|Arterial Stiffness|Arterial stiffness assessment will be performed by applanation tonometry (SphygmoCorTM; PWV Inc., Westmead, Sydney, Australia) with the patient being recumbent, 10 minutes before the measures were done. The carotid and femoral pulse will be acquired by applanation tonometry sequentially, allowing a single operator to acquire the measurement. The transit time from the R-wave of the simultaneously acquired electrocardiogram to the foot of the carotid and femoral pulse is measured. The difference acquired electrocardiogram to the foot of the carotid and femoral pulse is measured. The difference between these 2 transit times is divided by distances measured from the body surface to estimate the arterial path length in order to calculate carotid-femoral PWV.
15799997|NCT04451200|Drug|Busulfan Injection|injections doses will be personalized by PK at days -7 and -4
15799978|NCT04451356|Diagnostic Test|Lung ultrasonography|Examinations will be performed in the supine position. Scanning of the anterior and lateral chest will be performed on both sides of the chest, from the second to the fourth (on the right side to the fifth) intercostal spaces, at parasternal to mid-axillary lines. B-lines will be recorded in each intercostal space and were defined as a hyperechoic, coherent US bundle at narrow basis going from the transducer to the limit of the screen. B-lines starting from the pleural line can be either localized or scattered to the whole lung and be present as isolated or multiple artifacts. The sum of B-lines produces a score reflecting the extent of lung water accumulation (0 being no detectable B-line).
15799979|NCT04451343|Other|biographical interviews|A sociologist trained in the sociology of cancer, to enable participants to talk about their experiences and clearly distinguish the experiences of each individual
15799980|NCT04451330|Drug|Trifarotene cream|Trifarotene 50 mcg/g cream will be applied topically once daily on face for 12 weeks.
15799981|NCT04451330|Drug|Doxycycline hyclate|Doxycycline hyclate delayed release 120 mg tablets will be administered orally for 12 weeks.
15799982|NCT04451330|Drug|Trifarotene Vehicle|Trifarotene 50 mcg/g vehicle cream will be applied topically once daily on face for 12 weeks.
15799983|NCT04451330|Drug|Doxycycline Placebo|Doxycycline hyclate delayed release 120 mg placebo tablets will be administered orally for 12 weeks.
15799984|NCT04451317|Other|Questionnaire, phone call|phone call and 3 questionnaires on a digital platform
15799985|NCT04451291|Biological|Decidual Stromal Cells (DSC)|DSCs are involved in the immune system during pregnancy. The DSCs used in this study will come from laboratory grown allogeneic human decidual stromal cells obtained from donated placentas.
15799986|NCT04451278|Other|séquence resting state|The MRI examination will be performed on a 3T multi-parametric MRI. Compared to the standard protocol, patients will benefit from an additional sequence of f-mRI, called resting state, and performed before injection of gadolinium contrast agent.
15799987|NCT04451265|Other|MRI|Diffusion sequence (8 minutes long) added to the initial MRI
15799988|NCT04451252|Procedure|Fluoroscopically guided lumbar medial branch nerve radiofrequency denervation.|"While in prone position, lumbar facet joints are identified by fluoroscopy. 18 gauge needles are then advanced aiming to the medial branch of lumbar facet joints. Correct positioning is confirmed by anteroposterior and lateral fluoroscopy. Then, the needles are attached to the radiofrequency device. Correct positioning of the needles is confirmed also by sensitive stimulation (paresthesia evocation) with the following settings: 50 Hz (hertz), 1ms, 0,6V (volts). In order to avoid motor lesion, it is confirmed that no motor response is produced with 2Hz, 2ms (millisecond) and twice the voltage that produced sensitive response. After correct positioning and repositioning the needles if needed, conventional radiofrequency ablation of medial branch nerves is performed using the following settings: 90 seconds, 80º Celsius degrees.
~The selection of target facet joints is made based on clinical findings. Some patients receive bilateral while other unilateral facet joint denervation."
15799989|NCT04451252|Procedure|Fluoroscopically guided lumbar facet joint injection.|With the patient in prone position and guided by fluoroscopy, lumbar facet joints are identified. The 22 french needles are then advanced aiming to the lumbar facet joints. Correct positioning is confirmed with anteroposterior and lateral fluoroscopy. A mixture of 3 ml of ropivacaine 0,2% + 1 ml (40 mg) of triamcinolone (trigon depot) is prepared. 1 ml of the mixture is injected in each lumbar facet joint through the needles. Four facet joints are selected for therapy. Some patients receive bilateral and other unilateral but contiguous facet joint infiltration. The selection of target facet joints is made based on clinical and radiological findings.
15799990|NCT04451252|Procedure|Fluoroscopically guided lumbar epidural corticosteroid injection.|With the patient in prone position and guided by fluoroscopy, an epidural needle attached to a syringe filled with saline serum is advanced through the interlaminar approach using a loss of resistance technique for the identification of the lumbar epidural space. When loss of resistance is encountered, 1 ml of iodinated contrast is injected. After fluoroscopical confirmation of epidural spilling, a mixture of 4 ml of ropivacaine 0,1%, 2 ml (12 mg) of betamethasone and 2 ml of saline serum is injected in the epidural space. The lumbar level to which it infiltrates depends on each patient.
15799991|NCT04451252|Procedure|Fluoroscopically guided caudal epidural corticosteroid injection.|With the patient in prone position and guided by fluoroscopy, an epidural needle attached to a syringe filled with saline serum is advanced through the sacral hiatus using a loss of resistance technique for the identification of the epidural space. When loss of resistance is encountered, 2 ml of iodinated contrast is injected. After fluoroscopical confirmation of epidural spilling, a mixture of 7 ml of ropivacaine 0,2%, 2 ml (12 mg) of betamethasone and 7 ml of saline serum is injected in the epidural space.
15799992|NCT04451252|Procedure|Fluoroscopically guided pulsed radiofrequency of the lumbar dorsal root ganglion.|With the patient in prone position and guided by fluoroscopy, a 18 gauge needle is advanced aiming to the intervertebral foramen. Patient is cautioned about the paresthesia which will be felt. A lateral view was taken occasionally to confirm position. 0.5 ml of iodinated contrast is injected to confirm the position of the needle. Then 1 ml of the combination of 12mg of betamethasone and 1ml of ropivacaine 0.2% is injected over the affected root. Then, the needle is attached to the radiofrequency device. Correct positioning of the needles is confirmed also by sensitive stimulation (paresthesia evocation) with the following settings: 50 Hz, 1ms, 0,6V. In order to avoid motor lesion, it is confirmed that no motor response is produced with 2Hz, 2ms and twice the voltage that produced sensitive response. After correct positioning is confirmed, pulsed radiofrequency ablation of lumbar dorsal root ganglion is performed using the following settings: 4 minutes, 42ºC (degrees Celsius).
15799993|NCT04451252|Procedure|Fluoroscopically guided transforaminal epidural corticosteroid injection or lumbar selective root block.|With the patient in prone position and guided by fluoroscopy, a 22 french needle is then advanced aiming to the intervertebral foramen. Patient is cautioned about the paresthesia which will be felt along the course of the lumbar root when the needle touches the nerve. A lateral view was taken occasionally to confirm position. 0.5 ml of iodinated contrast is injected to confirm the position of the needle. Then 1 ml of the combination of 12mg of betamethasone and 1ml of ropivacaine 0.2% is injected over the affected root.
15799994|NCT04451239|Drug|topical steroids and cyclosporin-A|All patient will be treated with Topical 1% prednisolone acetate for 7 days as initial treatment +non-preserved artificial tears and cyclosporin A 0.5% four times daily .
15799995|NCT04451226|Drug|Fezolinetant|Oral
15799996|NCT04451213|Diagnostic Test|MRI head|MRI head
15800002|NCT04451174|Drug|Prednisone|Prednisone 40 mg days 1 to 4. Then, prednisone 20 mg days 5 to 8.
15800007|NCT04451148|Other|Obese with or without metabolic syndromesubjects|Children with obesity and with or without metabolic syndrome
15800008|NCT04451135|Diagnostic Test|Electroencephalographic (EEG)|EEG on nights after ECT session will be recorded using the DREEM device. Sleep EEG data will also be acquired for a minimum of one night prior to the first ECT session, providing a true baseline measure. The DREEM device allows continuous recording of multichannel EEG
15800009|NCT04451135|Diagnostic Test|Closed loop acoustic stimulation (CLAS)|Closed loop acoustic stimulation will be enabled on the DREEM headband on a subset of study participants. The device delivers stimulation in phase with the upstroke of the EEG slow wave (STIM) to boost slow oscillation activity. The timing of this stimulus augments the expression of subsequent slow waves.
15800010|NCT04451135|Diagnostic Test|Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR16)|The Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR16) is a measure of depression symptom severity that has been validated for clinical and research use53. It is a standard self-report measurement completed by patients prior to each ECT session
15800011|NCT04451135|Diagnostic Test|Ictal Electroencephalographic (EEG) Measurements|A high-density 65-electrode EEG scalp electrode net (EGI/Philips) with Elefix conductive gel injected within Ag/AgCl electrode sensors is utilized to monitor brain activity during the ictal period
15800012|NCT04451135|Diagnostic Test|Post-Ictal Electroencephalographic (EEG) Suppression Measurements|A board-certified epileptologist will review all seizures to assess seizure parameters, including duration of seizure and interval of PGES. Preprocessing of the PGES periods will be accomplished with band-pass filtering from 2 to 30 Hz with 1st order Butterworth filters.
15800013|NCT04451135|Diagnostic Test|Quantitative Measurements of Sleep Microstructure|Following EEG preprocessing of DREEM sleep recordings, SWA will be quantified using a custom-written MATLAB module as the average of total power spectral estimates within the 0.5-4 Hz frequency band in one minute intervals, during the first cycle of N3 sleep.
15800014|NCT04451122|Other|cleansing the eyelid margins|using eyelid cleaning wipes to cleansing the eyelid margins
15800015|NCT04451109|Device|Dilapan-S|Application of Dilapan-S and all other procedures regarding cervical ripening and induction of labor will be carried out as per the hospital's standard practice.
15800016|NCT04451096|Dietary Supplement|Probiotics with prebiotic|Patients were instructed to consume one sachet twice daily mixed with a glass of water, before or after meals, for a duration of 8 weeks
15800017|NCT04451096|Dietary Supplement|Placebo|Patients were instructed to consume one sachet twice daily mixed with a glass of water, before or after meals, for a duration of 8 weeks
15800018|NCT04451083|Drug|FOY-305|Multiple-dose of FOY-305 will be administered orally at 4 times/day.
15800019|NCT04451070|Other|Clinic First curriculum|"The Clinic First model was designed by the Association of Family Medicine Residency Directors (AFMRD) in collaboration with the University of California San Francisco's (UCSF) Center for Excellence in Primary Care. The components of the Clinic First model are summarized in the Association of American Medical Colleges' (AAMC) publication titled High-Functioning Primary Care Residency Clinics: Building Blocks for Providing Excellent Care and Training. Using the principles of Clinic First, the authors of this study drafted a Family Medicine residency curriculum to be implemented at David Grant Medical Center at the beginning of the 2020-2021 academic year."
15800020|NCT04451057|Device|high flow nasal cannula therapy|Once extubation has taken place, the child will be placed either on conventional oxygen therapy or high flow nasal cannulae according to randomization
15800021|NCT04451057|Device|low flow nasal cannula therapy|Once extubation has taken place, the child will be placed either on conventional oxygen therapy or high flow nasal cannulae according to randomization
15800022|NCT04451044|Device|Philips SyncVision system with Philips pressure wires|Intent to use physiologically-guided PCI using the Philips SyncVision system for determining the PCI strategy
15800023|NCT04451044|Procedure|standard of care angiographically-guided PCI|Intent to use PCI standard of care angiographically-guided PCI for determining the PCI strategy
15800024|NCT04451031|Behavioral|LiFT Program|
15800025|NCT04451018|Other|evaluation of arterial anomalies in upper limbs|evaluation of arterial anomalies in upper limbs with doppler ultrasound
15800026|NCT04451005|Other|0|Elderly patients with sarcopenia
15800054|NCT04450784|Other|collection of the clinical and biological characteristics of secondary AMLs in children|to record scientific and medical information on cases of secondary Acute Myeloid Leukemias that have occurred in France since 2013
15800027|NCT04450979|Dietary Supplement|Bioactive hydrolysate|"Participants will be given a bioactive vegetable hydrolysate. Subjects will be instructed to take one dose each morning and one dose each evening for the duration of the study.
~Each dose (10g) will be supplied in a sachet. Subjects will be instructed to mix the contents of the sachet with 200mls of water, mix until the powder is fully dissolved and drink immediately."
15800028|NCT04450966|Behavioral|Computer-facilitated Screening and Brief Intervention|cSBI includes: 1) computer self-administered screening that adolescents complete prior to seeing their clinician, immediately followed by 2) computer-delivered brief psychoeducation on the health risks of substance use to prime patients for the clinician encounter, and 3) a Clinician Report Form with screen results and prompts that clinicians use to provide motivational interviewing-based individualized counseling during the visit.
15800029|NCT04450953|Drug|Eplerenone 50mg/day (cross over design)|Eplerenone 50mg/day for 6 months followed
15800030|NCT04450953|Other|Period without eplerenone (cross over design)|6-month period without eplerenone
15800031|NCT04450940|Behavioral|PACV survey|
15800032|NCT04450940|Behavioral|Placebo survey|
15800033|NCT04450914|Behavioral|CV Prevention Choice Tool|The CV Prevention Choice SDM tool is a shared decision making intervention. It is embedded in the electronic health record and uses EHR data to estimate and display cardiovascular risk for individual patients and then foster conversations between clinicians and patients about available options for preventive care based on individual risk and preferences.
15800034|NCT04450914|Behavioral|Implementation Facilitation Strategies|During the active implementation stage, health systems will deploy tailored implementation facilitation and other tailored implementation strategies aimed at increasing adoption and use of shared decision making using CV Prevention Choice.
15800035|NCT04450901|Drug|YBL-006|Route of Administration: IV infusion; 0.5 mg/kg Q2W
15800036|NCT04450901|Drug|YBL-006|Route of Administration: IV infusion; 2 mg/kg Q2W
15800037|NCT04450901|Drug|YBL-006|Route of Administration: IV infusion; 5 mg/kg Q2W
15800038|NCT04450901|Drug|YBL-006|Route of Administration: IV infusion; 10 mg/kg Q2W
15800039|NCT04450901|Drug|YBL-006|Route of administration : IV infusion, 200 mg Q2W
15800040|NCT04450901|Drug|YBL-006|Route of administration : IV infusion, 300 mg Q3W
15800041|NCT04450901|Drug|YBL-006|Route of administration : IV infusion, 300 mg Q2W
15800042|NCT04450901|Drug|YBL-006|Route of administration : IV infusion, 200mg Q2W
15800043|NCT04450888|Other|The strategic use of messages in risk communication|The interventions in the EMT-OCSP study are strategic health messages delivered (gain-framed vs.loss-framed and long-term vs.short-term contexts) to individuals based on their calculated CVD-free life expectancy and potential interventional benefits.
15800044|NCT04450875|Dietary Supplement|Experimental group (with diet)|Two nutritionists performed both diet instruction and 24-hour reminder monitoring monthly. At the end of the three-month follow-up, the 24-hour reminder data such as food consumed, daily rations, and the monthly average of milligrams of consumed methionine contained in the food, were recorded in a database for subsequent analysis.
15800045|NCT04450862|Other|Cognitive Behavioural therapy self help intervention for anxiety|"The intervention will involve five key components:
~Psychoeducation - Increase awareness of how PH may affect emotional health, normalisation of difficulties, and discussion of how symptoms associated with anxiety may add to the burden of the disease.
~Cognitions - Identify and challenge negative automatic thoughts associated with anxiety.
~Coping skills - Educate and practice a range of behavioural coping methods to help participants better manage their physical symptoms associated with anxiety in PH.
~Exposure - Replace avoidance of anxiety provoking situations and activities using graded exposure.
~Relapse prevention - Focus on relapse prevention with implementation intentions and promotion of problem solving."
15800046|NCT04450849|Procedure|guided tissue regeneration with using an absorbable collagen membrane associated with inorganic bovine bone associated.|Dental surgical procedures that use barrier membranes to direct the growth of new bone and gingival tissue at sites with insufficient volumes or dimensions of bone or gingiva for proper function, esthetics or prosthetic restoration. Using an absorbable collagen membrane (Bio-Gide® Perio) associated with inorganic bovine bone associated with collagen matrix (Bio-Oss® Collagen).
15800047|NCT04450849|Procedure|guided tissue regeneration with using an absorbable collagen membrane associated or not with inorganic bovine bone associated with collagen matrix.|dental surgical procedures that use barrier membranes to direct the growth of new bone and gingival tissue at sites with insufficient volumes or dimensions of bone or gingiva for proper function, esthetics or prosthetic restoration. Using an absorbable collagen membrane (Bio-Gide® Perio) alone.
15800048|NCT04450836|Drug|Regorafenib then Trifluridine/Tipiracil|"REGORAFENIB 160 mg per day during 3 weeks followed by 1 week off of each 4-week cycle except for cycle 1.
~During first cycle: dose is started at 80 mg per day at week 1, 120 mg per day at week 2, 160 mg per day at week 3, followed by 1 week off.
~Then TRIFLURIDINE/TIPIRACIL 35 mg/m² Dose administered orally twice daily on Days 1 to 5 and Days 8 to 12 of each 4-week cycle."
15800049|NCT04450836|Drug|Trifluridine/Tipiracil then Regorafenib|"TRIFLURIDINE/TIPIRACIL 35 mg/m² Dose administered orally twice daily on Days 1 to 5 and Days 8 to 12 of each 4-week cycle.
~Then REGORAFENIB 160 mg per day during 3 weeks followed by 1 week off of each 4-week cycle except for cycle 1.
~During first cycle: dose is started at 80 mg per day at week 1, 120 mg per day at week 2, 160 mg per day at week 3, followed by 1 week off."
15800050|NCT04450823|Other|no intervention|no intervention study, survey amongst health workers
15800051|NCT04450810|Other|Observation of serum and salivary NLRP3 levels|Evaluation of serum and salivary NLRP3 levels
15800052|NCT04450797|Device|US -G VPS placement, done by BK Medical 5000 US with burr hole probe (type 9063 N11C5S, 11-5 MHz).|"US -G VPS placement, done by BK Medical 5000 US with burr hole probe (type 9063 N11C5S, 11-5 MHz).
~Head not fixed, placed on horseshoe head holder, no preoperative navigation planning, catheter will be cut in length after positioning under real-time US guidance."
15800053|NCT04450797|Device|Stereotactic navigation for VPS placement (Brainlab Dual Curve System with cranial navigation software version 3.1).|"Stereotactic navigation for VPS placement (Brainlab Dual Curve System with cranial navigation software version 3.1).
~Head fixed in head clamp, entry point, trajectory and catheter length planned based on preoperative computer tomography imaging, catheter placed using navigated stylet."
15800185|NCT04449757|Drug|Bicarbonated Ringer's solution|Method of administration: intravenous infusion; 500-1000ml each time; Speed of infusion: it is decided by the clinicians.
15800055|NCT04450771|Behavioral|Family-based Treatment for ARFID|This treatment includes 14 1-hour sessions that will be conducted approximately weekly over a 4 month period. It is a manualized treatment based on the model of FBT that employs the same interventions as standard FBT for AN and BN: externalization, agnosticism, parental empowerment, a behavioral focus on changing eating behavior.
15800056|NCT04450771|Behavioral|Manualized Non-Specific Usual Care for ARFID|This treatment is a manualized non-specific psycho-educational and motivational enhancement approach that is based on a supportive non-directive psychotherapy model. It consists of sessions with the child alone and 5 parent-only meetings, all of which are 1-hour over a 4 month period.
15800057|NCT04450758|Procedure|Bridge to Surgery (stent or stoma)|The study is an observational study and patients will not be randomized. Resection is defined as upfront surgical resection, Bridge to Surgery as a two stage procedure.
15800058|NCT04450745|Behavioral|Exercise in hypoxia|60 minutes training program of mixed exercise in normobaric hypoxic chamber
15800059|NCT04450745|Behavioral|Exercise in normoxia|60 minutes training program of mixed exercise in regular air conditions
15800061|NCT04450706|Other|Precision Medicine|"The tissue from the participant sample will be used for genome sequencing and organoid establishment for drug screening. Both solid tumor genome analysis (commercial and Welm genome) must be performed on tissue from the same biopsy. After the biopsy, the patient will begin uninformed therapy (standard of care or investigational in the context of a separate existing active clinical trial), as selected and directed by the treating physician. Once the results from the genome sequencing and drug screening are available, they will be returned to the treating physician. Upon progression on the uninformed line of therapy, the patient will begin a new therapy as directed by the treating physician. If the patient begins a therapy recommended by the precision oncology results then the next line of therapy will be deemed informed. While receiving the therapy, response assessments will be conducted until documented radiographic or clinical progression."
15800062|NCT04450706|Other|Physican Decision Making|"The results from the drug screening and mutation testing will be summarized and returned to the treating physician before the assignment of on study, second-line therapy. Before and after returning results, the treating physician will be administered a survey to assess the potential effect that the precision medicine results have on the selection of the following line of therapy. If a patient begins a therapy that was recommended by the precision medicine results, the therapy will be defined as the informed line of therapy."
15800063|NCT04450693|Biological|TTAX01|TTAX01 is a cryopreserved human umbilical cord product derived from donated human placental tissue following healthy, live, caesarian section, full-term births after determination of donor eligibility and placenta suitability. TTAX01 is manufactured by TissueTech Inc. utilizing a proprietary CRYOTEK® process, which devitalizes the living cells but retains the natural structural and biological characteristics relevant to this tissue. TTAX01 is aseptically processed in compliance with current Good Tissue Practices (cGTP). TTAX01 will be manufactured in various sizes, stored in a medium of lactated Ringer's/glycerol (1:1).
15800064|NCT04450693|Other|Standard care|"Standard care is defined in this protocol to consist of the following:
~Debridement;
~Wound cleansing, using sterile saline, a non-ionic cleanser or a hypochlorous solution. Antiseptic agents including hydrogen peroxide, acetic acid, chlorhexidine, povidone/iodine, and cetrimide should not be used. Topical antimicrobials and silver dressings are also prohibited;
~Primary wound dressings including a non-adherent, standard foam pad with or without a hydrogel beneath the dressing, or and alginate dressing, as is appropriate to maintain a moist wound environment while managing exudate;
~A secondary retention bandage appropriate to the amount of wound exudate, so as to avoid maceration of the peri-wound skin;
~Off-loading device appropriate to the location of wound with full length boot or total contact cast (unless not appropriate where a substitute off-loading device can be made with sponsor approval); and,
~Appropriate use of systemic antibiotics."
15800065|NCT04450680|Other|Beta-lactam Therapeutic Drug Monitoring|Monitoring serum beta-lactam levels to individualise beta-lactam doses and ensure therapeutic target attainment
15800066|NCT04450667|Dietary Supplement|Nutricia PreOp|Oral rehydration 2 hours before the scheduled cesarean section under spinal anesthesia
15800067|NCT04450654|Drug|Gamunex-C|Gamunex-C IVIG will be given at week 0 and week 4
15800068|NCT04450654|Drug|Albumin|1% albumin solution dosed at equivalent volume to the corresponding weight-based Gamunex-C IVIG dose will be given at week 0 and week 4
15800069|NCT04450641|Other|GuessWhat Mobile Application|The GuessWhat app is a charades style game and app that engages parent and child in fluid social interaction where the parent must guess what the child is acting out based on the prompt shown on the phone screen. Participants will use their own personal phone to download the study app. Parent and child will be encouraged to play using the emojis and emotion game mode at least 3 individual game sessions per week. Parents are asked to play GuessWhat with their child 3-4 times per week for 4 weeks.
15800070|NCT04450628|Procedure|Surgeon unblinded|"The surgeon will be able to augment the surgical intent based on EndoFLIP measurements, such as adding or removing hiatal sutures or repeating the fundoplication. The data will be evaluated to assess if intraoperative calibration influences postoperative symptoms by comparing the two groups.
~Surgery will be scheduled and patients will undergo intraoperative impedance planimetry with EndoFLIP obtaining measurements of the cross-sectional area, balloon pressure, minimum diameter, compliance, length of high pressure segment, and distensibility index of the EGJ using an 8cm EndoFLIP balloon. Sequential assessments will be performed to 30ml and 40ml for up to a minute for each volume of distension. An initial baseline measurement will be obtained after establishment of pneumoperitoneum. A second measurement will occur following hiatal dissection and mobilization but prior to crural closure. Two additional measurements will be obtained after hiatal closure and after fundoplication."
15800083|NCT04450589|Other|ALRV5XR Conditioner|"ALRV5XR Conditioner. Dose/Route/Schedule: 3-7 ml, topical, daily. The amount of conditioner used will vary by subject based on length of hair. Short hair will use approximately 3ml of conditioner per wash and long hair as much as 7 ml. For short hair, an amount equivalent to a quarter in the palm of a hand, and for long hair a half-dollar size.
~There should be no deviation from the daily nutriment regimen (although in the event a day is missed, subject should continue with regimen the following day"
15800186|NCT04449757|Drug|Lactated Ringer's solution|Method of administration: intravenous infusion; 500-1000ml each time; Speed of infusion: it is decided by the clinicians.
15800476|NCT04447183|Other|radioactive iodine|radioactive iodine: 30mCi±1.5mCi or 1.11GBq of 131I oral
15800071|NCT04450628|Device|EndoFLIP 1.0 System EF-100|"The surgeon will be able to augment the surgical intent based on EndoFLIP measurements, such as adding or removing hiatal sutures or repeating the fundoplication. The data will be evaluated to assess if intraoperative calibration influences postoperative symptoms by comparing the two groups.
~Surgery will be scheduled and patients will undergo intraoperative impedance planimetry with EndoFLIP obtaining measurements of the cross-sectional area, balloon pressure, minimum diameter, compliance, length of high pressure segment, and distensibility index of the EGJ using an 8cm EndoFLIP balloon. Sequential assessments will be performed to 30ml and 40ml for up to a minute for each volume of distension. An initial baseline measurement will be obtained after establishment of pneumoperitoneum. A second measurement will occur following hiatal dissection and mobilization but prior to crural closure. Two additional measurements will be obtained after hiatal closure and after fundoplication."
15800072|NCT04450615|Other|Core stability|"The exercise protocol consists of the following sets and repetitions, with a total duration of 5 weeks and a frequency of 3 sessions per week.
~Dynamic exercises: 2 sets of 10 to 15 repetitions (each side) Isometric exercises: 2 sets of 5 to 15 seconds (each side) Week 1- As mentioned above Week 2- Add 1 set Week 3 - Add 5 seconds and 5 repetitions Week 4 - Add 1 set Week 5- Add 5 seconds and 5 repetitions"
15800073|NCT04450602|Dietary Supplement|ALRV5XR|"ALRV5XR oral supplement. Dose/Route/Schedule: 1 capsule/oral twice daily. Take one capsule in the morning and one capsule in the evening. Take 30-60 minutes before food. If stomach upset occurs, subjects will be instructed to take the capsule at the beginning of a meal.
~There should be no deviation from the daily nutriment regimen (although in the event a capsule or day is missed, subject should continue with regimen the following day.)"
15800074|NCT04450602|Other|ALRV5XR Shampoo|"ALRV5XR Shampoo. Dose/Route/Schedule: 3-7 ml, topical, daily. The amount of shampoo used will vary by subject, based on length of hair. Short hair will use approximately 3ml of shampoo per wash and long hair as much as 7 ml. For short hair, an amount equivalent to a quarter in the palm of a hand, and for long hair a half-dollar size.
~There should be no deviation from the daily nutriment regimen (although in the event a day is missed, subject should continue with regimen the following day"
15800075|NCT04450602|Other|ALRV5XR Conditioner|"ALRV5XR Conditioner. Dose/Route/Schedule: 3-7 ml, topical, daily. The amount of conditioner used will vary by subject based on length of hair. Short hair will use approximately 3ml of conditioner per wash and long hair as much as 7 ml. For short hair, an amount equivalent to a quarter in the palm of a hand, and for long hair a half-dollar size.
~There should be no deviation from the daily nutriment regimen (although in the event a day is missed, subject should continue with regimen the following day"
15800076|NCT04450602|Other|ALRV5XR Hair Follicle Serum (Nutriment)|"ALRV5XR topical Hair Follicle serum (Nutriment), sealed in an airless pump dispensing bottle, metered at 0.2ml per depression. Dose/Route/Schedule: 1ml, topical, daily, applied at night.
~Topical serum (referred to as the Nutriment) dosage is metered as 5 x depressions of plunger per day to cover areas of thinning scalp and adjacent scalp areas. Care should be taken to limit the Nutriment in hair. Each depression is metered at 0.2ml for a daily dose of 1.0 ml. Each container has 30ml of Nutriment. Nutriment will dry within a few minutes and any on the hair will also dry. The dried effect in the hair should not cause oiliness or dryness on scalp or hair. There should be no deviation from the daily nutriment regimen (although in the event a day is missed, subject should continue with regimen the following day.)"
15800077|NCT04450602|Dietary Supplement|Placebo|"Placebo oral supplement. Dose/Route/Schedule: 1 capsule/oral twice daily. Take one capsule in the morning and one capsule in the evening. Take 30-60 minutes before food. If stomach upset occurs, subjects will be instructed to take the capsule at the beginning of a meal.
~There should be no deviation from the daily nutriment regimen (although in the event a capsule or day is missed, subject should continue with regimen the following day.)"
15800078|NCT04450602|Other|Placebo Shampoo|"Placebo Shampoo. Dose/Route/Schedule: 3-7 ml, topical, daily. The amount of shampoo used will vary by subject, based on length of hair. Short hair will use approximately 3ml of shampoo per wash and long hair as much as 7 ml. For short hair, an amount equivalent to a quarter in the palm of a hand, and for long hair a half-dollar size.
~There should be no deviation from the daily nutriment regimen (although in the event a day is missed, subject should continue with regimen the following day"
15800079|NCT04450602|Other|Placebo Conditioner|"Placebo Conditioner. Dose/Route/Schedule: 3-7 ml, topical, daily. The amount of conditioner used will vary by subject based on length of hair. Short hair will use approximately 3ml of conditioner per wash and long hair as much as 7 ml. For short hair, an amount equivalent to a quarter in the palm of a hand, and for long hair a half-dollar size.
~There should be no deviation from the daily nutriment regimen (although in the event a day is missed, subject should continue with regimen the following day"
15800080|NCT04450602|Other|Placebo Hair Follicle Serum (Nutriment)|"Placebo topical Hair Follicle serum (Nutriment), sealed in an airless pump dispensing bottle, metered at 0.2ml per depression. Dose/Route/Schedule: 1ml, topical, daily, applied at night.
~Topical serum (referred to as the Nutriment) dosage is metered as 5 x depressions of plunger per day to cover areas of thinning scalp and adjacent scalp areas. Care should be taken to limit the Nutriment in hair. Each depression is metered at 0.2ml for a daily dose of 1.0 ml. Each container has 30ml of Nutriment. Nutriment will dry within a few minutes and any on the hair will also dry. The dried effect in the hair should not cause oiliness or dryness on scalp or hair. There should be no deviation from the daily nutriment regimen (although in the event a day is missed, subject should continue with regimen the following day.)"
15800081|NCT04450589|Dietary Supplement|ALRV5XR|"ALRV5XR oral supplement. Dose/Route/Schedule: 1 capsule/oral twice daily. Take one capsule in the morning and one capsule in the evening. Take 30-60 minutes before food. If stomach upset occurs, subjects will be instructed to take the capsule at the beginning of a meal.
~There should be no deviation from the daily nutriment regimen (although in the event a capsule or day is missed, subject should continue with regimen the following day.)"
15800082|NCT04450589|Other|ALRV5XR Shampoo|"ALRV5XR Shampoo. Dose/Route/Schedule: 3-7 ml, topical, daily. The amount of shampoo used will vary by subject, based on length of hair. Short hair will use approximately 3ml of shampoo per wash and long hair as much as 7 ml. For short hair, an amount equivalent to a quarter in the palm of a hand, and for long hair a half-dollar size.
~There should be no deviation from the daily nutriment regimen (although in the event a day is missed, subject should continue with regimen the following day"
15800179|NCT04449822|Procedure|Emergency surgery|Surgical decompression with colostomy with or without resection and eventual re-anastomosis.
15800180|NCT04449822|Procedure|Colonic stenting|The colonic stent placement to relieve the colonic obstruction.
15800084|NCT04450589|Other|ALRV5XR Hair Follicle Serum (Nutriment)|"ALRV5XR topical Hair Follicle serum (Nutriment), sealed in an airless pump dispensing bottle, metered at 0.2ml per depression. Dose/Route/Schedule: 1ml, topical, daily, applied at night.
~Topical serum (referred to as the Nutriment) dosage is metered as 5 x depressions of plunger per day to cover areas of thinning scalp and adjacent scalp areas. Care should be taken to limit the Nutriment in hair. Each depression is metered at 0.2ml for a daily dose of 1.0 ml. Each container has 30ml of Nutriment. Nutriment will dry within a few minutes and any on the hair will also dry. The dried effect in the hair should not cause oiliness or dryness on scalp or hair. There should be no deviation from the daily nutriment regimen (although in the event a day is missed, subject should continue with regimen the following day.)"
15800085|NCT04450589|Dietary Supplement|Placebo|"Placebo oral supplement. Dose/Route/Schedule: 1 capsule/oral twice daily. Take one capsule in the morning and one capsule in the evening. Take 30-60 minutes before food. If stomach upset occurs, subjects will be instructed to take the capsule at the beginning of a meal.
~There should be no deviation from the daily nutriment regimen (although in the event a capsule or day is missed, subject should continue with regimen the following day.)"
15800086|NCT04450589|Other|Placebo Shampoo|"Placebo Shampoo. Dose/Route/Schedule: 3-7 ml, topical, daily. The amount of shampoo used will vary by subject, based on length of hair. Short hair will use approximately 3ml of shampoo per wash and long hair as much as 7 ml. For short hair, an amount equivalent to a quarter in the palm of a hand, and for long hair a half-dollar size.
~There should be no deviation from the daily nutriment regimen (although in the event a day is missed, subject should continue with regimen the following day"
15800087|NCT04450589|Other|Placebo Conditioner|"Placebo Conditioner. Dose/Route/Schedule: 3-7 ml, topical, daily. The amount of conditioner used will vary by subject based on length of hair. Short hair will use approximately 3ml of conditioner per wash and long hair as much as 7 ml. For short hair, an amount equivalent to a quarter in the palm of a hand, and for long hair a half-dollar size.
~There should be no deviation from the daily nutriment regimen (although in the event a day is missed, subject should continue with regimen the following day"
15800088|NCT04450589|Other|Placebo Hair Follicle Serum (Nutriment)|"Placebo topical Hair Follicle serum (Nutriment), sealed in an airless pump dispensing bottle, metered at 0.2ml per depression. Dose/Route/Schedule: 1ml, topical, daily, applied at night.
~Topical serum (referred to as the Nutriment) dosage is metered as 5 x depressions of plunger per day to cover areas of thinning scalp and adjacent scalp areas. Care should be taken to limit the Nutriment in hair. Each depression is metered at 0.2ml for a daily dose of 1.0 ml. Each container has 30ml of Nutriment. Nutriment will dry within a few minutes and any on the hair will also dry. The dried effect in the hair should not cause oiliness or dryness on scalp or hair. There should be no deviation from the daily nutriment regimen (although in the event a day is missed, subject should continue with regimen the following day.)"
15800089|NCT04450576|Diagnostic Test|Glycosylated hemoglobin|Glycosylated hemoglobin levels associated with correlative measures of diastolic cardiac function
15800090|NCT04450563|Drug|14-day outpatient intervention|The patient will be on the closed-loop insulin system and the intervention drug (placebo, empagliflozin 2.5 mg, or empagliflozin 5 mg) for 14 days. Insulin reductions will be made to avoid hypoglycemia with the drug agent. Remote contact around Day 4 (+/- 2 days) will be made to optimize insulin settings. The last 10 days will be used to assess continuous glucose monitoring data during each intervention. A wash-out period of 7 - 21 days will separate each intervention.
15800091|NCT04450550|Device|VeNS device|VeNS treatment
15800092|NCT04450550|Device|Sham VeNS device|Sham treatment of VeNS
15800093|NCT04450537|Behavioral|Vape Messaging Intervention|Participants will be exposed to 10 vape education messages
15800094|NCT04450524|Behavioral|Hypnosis|Participants received hypnotic induction with hypnotic suggestions for their eating behaviors.
15800095|NCT04450524|Behavioral|Food inhibition training|Training the associations between foods and motor inhibition using a GO-NO-GO computer task.
15800096|NCT04450524|Behavioral|Control|A simple GO-NO-GO task
15800097|NCT04450511|Device|Magnetic stimulation -Armchair type (MS)|MS was applied two days a week, 20 minutes a day, a total of 12 sessions for 6 weeks.
15800098|NCT04450511|Other|Bladder Training (BT)|Bladder Training (BT)
15800099|NCT04450498|Biological|Yuxi Walvax MPV ACYW® vaccine|Walvax MPV ACYW vaccine is a sterile formulation of polysaccharide A,C,Y,W-135. One dose of 0.5 mL contains 50 µg of each A,C,Y,W-135 purified polysaccharide. The vaccine is presented in two vials: one containing the lyophilized cake of A,C,Y,W purified polysaccharides and the other the sterile water for injection as diluent. After reconstitution the one dose of 0.5 mL is ready for subcutaneous injection. The antigen content is similar to other internationally marketed polysaccharide vaccines that have been in use for decades as Menomune® Sanofi and Mencevax® Pfizer , all containing 50 µg of each A,C,Y,W purified polysaccharide that as one dose schedule are recommended for use in subjects > 2 years of age and have shown to be safe and immunogenic.
15800100|NCT04450498|Biological|Sanofi Pasteur Menactra® vaccine|The vaccine presentation is a full liquid formulation in a single dose of 0.5 mL with the following composition: Meningococcal group A polysaccharide 4 µg; Meningococcal group C polysaccharide 4 µg; Meningococcal group Y polysaccharide 4 µg; Meningococcal group W polysaccharide 4 µg; Diphtheria toxoid protein total 48 µg; Sodium phosphate 0.7 mg; Sodium chloride 4.35 mg.
15800101|NCT04450485|Procedure|Total knee arthroplasty|Total knee arthroplasty
15800102|NCT04450459|Diagnostic Test|ergospirometer test|ergospirometric test will be done before cardiac catheterisation and invasive measurement of FFR
15800103|NCT04450446|Drug|Low molecular weight heparin|Anticoagulation therapy
15800104|NCT04450433|Diagnostic Test|aortic dissection and healthy people|Differential expression of metabolites in patients with aortic dissection and healthy people
15800105|NCT04450420|Other|Simulation based curriculum|See arm/group description
15800106|NCT04450420|Other|Standard training|See arm/group description
15800109|NCT04450394|Drug|LY3209590|Administered SC
15800110|NCT04450394|Drug|Insulin Degludec|Administered SC
15800111|NCT04450381|Device|Rad-67 Pulse oximeter & DCI Mini sensor|Noninvasive pulse oximeter that measures hemoglobin
15800181|NCT04449809|Behavioral|Exercise program|3x per week group monitored group exercise sessions
15800514|NCT04446897|Biological|mesenchymal stem cells|autologous mesenchymal stem cells
15800112|NCT04450368|Device|Sylvee|The investigators have developed a small sensor that has the same characteristics as a combined hearing aid used for Tinnitus. It has a noise generator intended to transmit white noise (2 - 20 KHz) and a microphone similar to those used in hearing aids to provide sound amplification. Our sensor is substantially equivalent to legally FDA approved marketed devices that can be used for several hours per day. Although it will introduce new indications for use (lung resonance capture), it has the same technological characteristics and will not introduce new hazards or safety risks. Several sound-based devices are already in use for clearing mucus from the lungs by generating and delivering low frequency sound that vibrates the airways and lung secretions, causing them to thin and become expelled. The devices are placed on the patient's chest for up to 3-4 hours in COPD, cystic fibrosis (CF) and other lung diseases.
15800113|NCT04450355|Drug|Nefopam 80mg/day|continuous nefopam infusion
15800114|NCT04450355|Drug|Normal saline|continuous normal saline infusion
15800115|NCT04450342|Device|Arthroscopic rotator cuff repair with REGENETEN™ Bioinductive Implant augmentation|The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear. The REGENETEN Bioinductive Implant is a medical device intended for the management and protection of tendon injuries. The REGENETEN Bioinductive Implant is indicated for the management and protection of rotator cuff tendon injuries in which there has been no substantial loss of tendon tissue. The REGENETEN Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons. The implant is designed to provide a layer of collagen between a flat tendon and the surrounding tissue. After hydration, the implant is an easy-to-handle, pliable, nonfriable, porous collagen sheet.
15800116|NCT04450342|Procedure|Arthroscopic rotator cuff repair|The Arthroscopic rotator cuff repair aims at repairing the rotator cuff following tendon tear without supplement.
15800117|NCT04450342|Device|Arthroscopic rotator cuff repair for revision surgery|The Arthroscopic rotator cuff repair can also occur in recurrent tears. The REGENETEN Bioinductive Implant will be applied during the ARCR procedure.
15800118|NCT04450329|Drug|SB15 (Proposed aflibercept biosimilar)|Subjects randomized into SB15 group will receive SB15 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48. Starting at Week 32, subjects transited from Eylea to SB15 will receive SB15 2 mg (0.05 mL) via intravitreal injection every 8 weeks.
15800119|NCT04450329|Drug|Eylea (Aflibercept)|Subjects randomized into Eylea group will receive Eylea 2 mg (0.05 mL) via intravitreal injection every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) once every 8 weeks until Week 48.
15800120|NCT04450316|Drug|Naltrexone|4.5mg tab (low-dose) nightly
15800121|NCT04450316|Drug|Placebo|1 tab nightly
15800122|NCT04450303|Behavioral|Telehealth CBT|The Coordinated Anxiety Learning and Management (CALM) program is an evidence-based, computer-assisted protocol for cognitive behavioral therapy (CBT) for anxiety, depression, and/or post-traumatic stress. CALM will be implemented via secure and HIPAA compliant video-conferencing software (enterprise Zoom), following modifications to address obstacles associated with physical distancing and the tele-health medium.
15800123|NCT04450290|Device|CIDEXEL implant|The newly developed MED-EL Cochlear Implant incorporates the anti-inflammatory agent dexamethasone (DEX) into the electrode array. The passive elution of DEX during the post-implantation period has the purpose of counteracting the increase of the post-operative impedance induced by the insertion trauma.
15800124|NCT04450277|Procedure|Emergency surgery|Emergency surgery vs conservative management
15800125|NCT04450264|Behavioral|African Immigrant Breast Cancer Education Program|African immigrant women are at significant risk for not participating in preventive screening, such as for breast cancer. Thus, this project will culturally adapt an existing evidenced-based, the Witness Project, by identifying potential barriers and guided by the Health Belief Model incorporate those findings into a group-based narrative education program for English and French-speaking African immigrant women. The program content will include: (1) information about the benefits of early detection of breast cancer screening, (2) education about disparities in breast cancer, (3) disparities in breast cancer screening among African immigrant women, and (4) will address the unique barriers and facilitators of African immigrant women identified in Aim 1 of this study. The program will use a culturally matched peer approach to educate and model successful experiences with mammography screening.
15800126|NCT04450251|Other|Data Collection|Collect observational fetal electrocardiogram (ECG) readings with a novel wearable device.
15800127|NCT04450238|Behavioral|Routine care inpatient treatment|All participants are receiving inpatient treatment consisting of a variety of psychological interventions such as cognitive-behavioral therapy, third-wave interventions, psycho-education and in some cases medication.
15800128|NCT04450212|Genetic|Phase I, Buccal Swab Collection for DNA Isolation|Buccal swab will be taken from study participants for DNA isolation.
15800129|NCT04450212|Dietary Supplement|Phase II, Vitamin K (Vitacost) Supplementation|1-mg/day phylloquinone (Vitacost; Natures Life K-1 Phylloquinone) for 10 consecutive days. Each dose will be taken in the morning (~ 8 am), with one half pint of 2% milk to facilitate absorption. Blood and urine samples collection before and during the vitamin K supplementation period.
15800130|NCT04450199|Drug|Vitamin D2|Vitamin D tablets
15800131|NCT04450199|Other|Placebo|Over encapsulated sugar pills
15800132|NCT04450186|Other|EEG/fMRI neurofeedback|EEG/fMRI neurofeedback
15800133|NCT04450173|Drug|Ibrutinib|Given PO
15800134|NCT04450173|Biological|Obinutuzumab|Given IV
15800135|NCT04450173|Drug|Venetoclax|Given PO
15800136|NCT04450160|Drug|Anhydrous Enol-Oxaloacetate (AEO)|Oral supplementation with AEO along with the Standard of Care (Temozolomide)
15800137|NCT04450160|Other|Standard of Care|Standard of Care Temozolomide
15800138|NCT04450147|Behavioral|Tai Chi/Qigong vs. Walking/Stretching|Both interventions can be thought of as a form of movement and exercise.
15800139|NCT04450134|Other|Lactose|Placebo: Lactose capsules
15800140|NCT04450134|Drug|Fexofenadine Hydrochloride|H1 receptor antagonist: 540 mg Fexofenadine Hydrochloride
15800141|NCT04450134|Drug|Famotidine|H2 receptor antagonist: 40 mg Famotidine
15800142|NCT04450134|Other|High-intensity interval training (HIIT)|6 weeks HIIT
15800182|NCT04449783|Other|pre-operative screening|reported symptoms plus nose and throat swabbing 48 hrs prior to surgery
15800183|NCT04449783|Other|telephone consult|telephone consult 14 days (+/- 2 days) to assess for any COVID-19 symptoms
15800143|NCT04450121|Device|Patients will be intubated using Air-Q airway|"Both groups:
~Grade 1: Split airway provides an unobstructed path for bronchoscope from mouth to glottis.
~Grade 2: Tongue rests against posterior pharyngeal wall causing partial obstruction to bronchoscope.
~Grade 3: Epiglottis rests against posterior pharyngeal wall causing partial obstruction to bronchoscope.
~Grade 4: Tongue and epiglottis rest against posterior pharyngeal wall, both causing partial obstruction to bronchoscope.
~Grade 5: Tongue rests against posterior pharyngeal wall causing total obstruction to bronchoscope (failure).
~Grade 6: Epiglottis rests against posterior pharyngeal wall causing total obstruction to bronchoscope (failure)"
15800144|NCT04450095|Drug|Ambrisentan 10 MG|be given once a day for 5 days, starting 48 hours before surgery
15800145|NCT04450082|Procedure|One anastomosis gastric bypass|The linear stapler divides the stomach horizontally at the junction of the corpus and antrum at the level of crow's foot. In cases where the pre-operative study has shown the presence of the gastric fundus, if possible the fundus was dissected and a long, narrow gastric pouch was designed starting from beyond the crow's foot to just lateral the angle of His over a 42-Fr orogastric tube. Gastrojejunostomy was then performed between 200-220 cm distally to the ligament of Treitz using a 45-mm.
15800146|NCT04450069|Combination Product|CLBR001 and SWI019|Investigational immunotherapy for B cell malignancies
15800147|NCT04450056|Other|No intervention|No intervention
15800148|NCT04450043|Behavioral|Run-In Sessions 1-5|Session 1 explores patient goals and wishes for life after cancer treatment with a study interventionist. Sessions 2-5 focuses on learning and practicing skills to enhance post-treatment quality of life.
15800149|NCT04450043|Behavioral|RCT Transitions Program Sessions 1-5|Sessions 1-5 focuses on learning and practicing skills to enhance post-treatment quality of life.
15800150|NCT04450043|Behavioral|RCT Control Session|Participants will receive a 1-session intervention, focused on reviewing goal progress for post-treatment quality of life, providing encouragement and support, identifying any current concerns, and providing tailored recommendations and resources.
15800151|NCT04450030|Drug|Methyl Prednisolonate|2000mg intravenous methyl prednisolone per day for five consecutive days
15800152|NCT04450030|Procedure|Immunoadsorption|6 courses of tryptophane-based immunoadsorption within up to 12 days
15800153|NCT04450017|Diagnostic Test|The demographic, clinical, laboratory, and instrumental data|Measurement of the demographic, clinical data, laboratory data, and instrumental data
15800154|NCT04450004|Biological|Intramuscular Vaccine|Subjects will receive two intramuscular (IM) injections 21 days apart (Day 0 and Day 21), into the deltoid region of the alternating arm (each arm will be injected once), with their assigned vaccine.
15800155|NCT04449991|Procedure|Repeat kidney biopsy|Intensification of immunosuppression if NIH AI > 3
15800156|NCT04449965|Drug|Povidone-iodine|This will be performed twice daily for two weeks.
15800157|NCT04449965|Drug|Placebo|This will be performed twice daily for two weeks.
15800158|NCT04449952|Other|Listerine Cool Mint|Participants use 20 mL of Listerine cool mint mouth rinse for 30 sec after brushing
15800159|NCT04449952|Other|5% Hydroalcohol Mouth Rinse|Participants use 20 mL of 5% Hydroalcohol mouth rinse for 30 sec after brushing.
15800160|NCT04449952|Other|Colgate Cavity Protection Toothpaste|Participants used Colgate cavity protection toothpaste for brushing teeth twice daily.
15800161|NCT04449952|Other|Alcohol-Free Essential Oil Containing (AFEO) Mouth Rinse Lead Formula|Participants use 20 mL of AFEO mouth rinse lead formula for 30 sec after brushing.
15800162|NCT04449952|Device|Concept Curve Winter Series Toothbrush|Participants will brush teeth at least one minute with provided bristled toothbrush.
15800163|NCT04449952|Device|Listerine Cool Mint Floss|Participants will use marketed fluoride-containing dentifrice, floss.
15800164|NCT04449939|Drug|KY1005|A human anti-OX40 ligand monoclonal antibody
15800165|NCT04449926|Biological|Bacillus of Calmette and Guerin (BCG)|Prime and boost vaccination
15800168|NCT04449900|Other|This is observational study with the examination of OCTA|This is observational study with the examination of OCTA
15800169|NCT04449887|Drug|Xiangsha Liujunzi granules|A traditional Chinese medicine compound, taken three times a day, one bag at a time, for a total of 28 days
15800170|NCT04449874|Drug|GDC-6036|The starting dose of GDC-6036 in the combination Arms B, C, D, E and F will be determined from Stage I Arm A (single-agent dose escalation).
15800171|NCT04449874|Drug|Atezolizumab|A 1200 milligram (mg) intravenous (IV) infusion of atezolizumab will be administered on Day 1 of 21 day cycles.
15800172|NCT04449874|Drug|Cetuximab|Cetuximab will be administered at an initial dose of 400 milligram per square meter (mg/m^2) IV infusion followed by 250 mg/m^2 IV infusion weekly in 21 day cycles.
15800173|NCT04449874|Drug|Bevacizumab|A 15 milligram per kilogram (mg/kg) IV infusion of bevacizumab will be administered on Day 1 of 21 day cycles.
15800174|NCT04449874|Drug|Erlotinib|150 mg of erlotinib will be administered PO QD in 21 day cycles.
15800175|NCT04449874|Drug|GDC-1971|The starting dose of GDC-1971 will be determined from its single-agent dose escalation.
15800176|NCT04449861|Drug|Durvalumab plus chemotherapy|"Drug: Durvalumab IV infusions every 3 weeks for 4-6 cycles and every 4 weeks thereafter until PD or other discontinuation criteria.
~Drug: Carboplatin 4-6 cycles every 3 weeks
~Drug: Cisplatin 4-6 cycles every 3 weeks
~Drug: Etoposide 4-6 cycles every 3 weeks"
15800177|NCT04449848|Other|Sitting after intra tympanic injection|Sitting after intra tympanic injection
15800178|NCT04449835|Procedure|Intracept Procedure|radio frequency ablation of the basivertebral nerve for the relief of chronic vertebrogenic low back pain
15800187|NCT04449744|Other|MySafeRx Inspire Plus|The MySafeRx™ platform is a combination of several key components, including daily videoconferencing check-ins with motivational interviewing-based recovery coaching, text-messaging reminders, secure storage of buprenorphine/naloxone medication within a secure electronic pill dispenser, and a standardized protocol for supervising self-administration of medication via videoconferencing.
15800188|NCT04449744|Other|MySafeRx Inspire Flex|The MySafeRx™ platform is a combination of several key components, including daily videoconferencing check-ins with motivational interviewing-based recovery coaching, text-messaging reminders, secure storage of buprenorphine/naloxone medication within a secure electronic pill dispenser, and a standardized protocol for supervising self-administration of medication via videoconferencing. Based on clinical need, the participant may be assigned an electronic pill dispenser for the duration of the study by their clinical team.
15800189|NCT04449718|Dietary Supplement|Vitamin D|200,000 IU on admission
15800190|NCT04449718|Dietary Supplement|Placebo|200,000 IU on admission
15800191|NCT04449692|Drug|Dasiglucagon|Abdominal s.c. administration
15800192|NCT04449692|Other|Carbohydrate (dextrose tablets)|Oral administration
15800193|NCT04449679|Other|Patient Monitoring System|Receive RT-CAMSS
15800194|NCT04449679|Other|Questionnaire Administration|Complete questionnaires
15800195|NCT04449679|Other|Consultation|Receive tailored feedback, including consultation with nurse
15800196|NCT04449666|Diagnostic Test|Neuropsychological assessment and structural MRI|Complex neuropsychological assessment testing attentional and memory functions. Additionally, a structural MRI is measured.
15800197|NCT04449640|Procedure|Hysteroscopic septum resection.|Resection of a uterine septum by hysteroscopic surgery.
15800198|NCT04449627|Other|Feeling Good Digital App|Audio based tracks using Jacobson relaxation and mindfullness based cognitive therapy (MBCT) techniques including positive visualisation.
15800199|NCT04449614|Procedure|Thoracoscopic CPAM resection|Surgical removal of lung lesion
15800200|NCT04449601|Other|clinical assesment|Comparison of Hypertensive group and normotensive group
15800201|NCT04449588|Drug|BDB-001 Injection|BDB-001 Injection+Conventional treatment
15800202|NCT04449588|Other|Conventional treatment|Conventional treatment only. Local guidelines should be integrated to choose the best supportive care.
15800203|NCT04449575|Other|eSwabs|from skin
15800204|NCT04449549|Drug|Nilotinib|Nilotinib: The BCR-Abl kinase inhibitor; Nilotinib demonstrated greater than additive activity in combination with Paclitaxel in preclinical xenograft models, justifying the clinical evaluation of this combination for its antitumor activity.
15800205|NCT04449549|Drug|Paclitaxel|Paclitaxel: anti-tubulin agent; Nilotinib demonstrated greater than additive activity in combination with Paclitaxel in preclinical xenograft models, justifying the clinical evaluation of this combination for its antitumor activity
15800206|NCT04449536|Drug|Mesna|Administration of a single oral dose, using film-coated tablets of either 400 mg or 600 mg or a combination of maximum 3 tablets up to a maximum of 1600 mg
15800207|NCT04449510|Other|Electronic Cigarette|E-cigarette Device: The delivery device will be a variable wattage all-in-one device with operating wattage of 7.0 - 75.0 W. The device will be set at 10 watts for the study visits.
15800208|NCT04449484|Drug|MEDI1341|Intravenous infusion over 60 minutes
15800209|NCT04449484|Other|Placebo|Intravenous infusion over 60 minutes
15800210|NCT04449471|Drug|Naproxen tablet|For this single intervention arm, each subject will receive a single 220-mg dose of naproxen sodium (Aleve), followed by urine collection for 24-hours.
15800211|NCT04449458|Behavioral|Positively Me|12 session smoking cessation intervention based on Social Cognitive Theory, designed for people with certain health conditions (8 primary sessions, followed by 4 booster sessions)
15800212|NCT04449458|Behavioral|Positively Living|12 session healthy living intervention based on Social Cognitive Theory, designed for people with certain health conditions (8 primary sessions, followed by 4 booster sessions)
15800213|NCT04449445|Dietary Supplement|Isocaloric and iso-nitrogenous standard enteral tube feeds|Dietary supplement
15800214|NCT04449445|Dietary Supplement|Nestle IMPACT AR|Dietary supplement
15800215|NCT04449432|Behavioral|GROWell (Interactive Obesity Treatment Approach)|Personalized messaging via cell phone to support healthy eating behaviors during pregnancy and through 6 months postpartum
15800216|NCT04449432|Behavioral|Attention Support Control|Personalized messaging via cell phone to support healthy behaviors during pregnancy and through 6 months postpartum
15800217|NCT04449419|Other|There is not intervention.|There is not intervention
15800218|NCT04449393|Device|Emdogain® FL|Emdogain® FL is an enamel matrix derivative intended for subgingival and topical application in conjunction with scaling and root planing procedures to provide regeneration of tooth support lost due to periodontal disease. Emdogain® FL has been shown to be effective in residual pockets with probing depths from 5mm to 9mm with no furcation involvement in patients with adequate plaque control. Emdogain® FL has also been shown to enhance the early healing of periodontal soft tissue wounds resulting from the instrumentation of periodontal pockets.
15800219|NCT04449393|Other|Scaling and root planing|Scaling and root planing procedures as part of non-surgical periodontal therapy involves mechanical removal of dental plaque and calculus using curettes and sonic scalers.
15800220|NCT04449380|Drug|Interferon-ß-1a|IFNβ-1a will be administered subcutaneously at a dose of 44 mcg (equivalent to 12 million international units), three times per week at least 48 hours apart, for a total of two weeks. All patients will receive a total dose of 264 mcg (72 million international units) under physician control
15800221|NCT04449380|Combination Product|Standard of Care (SOC)|Any pharmacological (e.g. antibiotics, etc.) and non-pharmacological (e.g. oxygen, ventilation, etc.) treatments prescribed on clinical grounds
15800222|NCT04449367|Procedure|ultrasound guided erector spinae plane block|bilatral block given to patients under general anaesthesia for thoracic spine sugery to contorl post operative pain
15800250|NCT04449120|Behavioral|Mediterranean diet-based nutritional education intervention|The patients in the nutritional intervention group will receive dietary advice on how to follow a Mediterranean diet. The dietary recommendations will be given at the beginning of the study by nutritionists using comprehensive written material.
15800473|NCT04447209|Other|Dietary counselling on Food Groups according to IYC Feeding practices, WHO|Monitoring of Dietary diversity and growth
15800223|NCT04449354|Device|HidraWear Ax|An adhesive free wound dressing fixation device for people living with Hidradenitis Suppurativa (HS), Hidrawear AX, designed to make dressing changes quick and easy for subjects. The unique features of the product completely remove the use of adhesives on the skin.The body conforming garment acts as a second skin and incorporates largely perforated panels over wound affected areas, minimising skin contact and aerating the area. The main function of the perforated is to act as a retaining device for the wound pads. The garment facilitates easy insertion, removal, precise positioning and adjustment of a non- adhesive wound dressing onto the effected wound space. The perforated section of the garment sits on the outer surface of the dressing providing provisional fixation. Next, an outer patch is placed on the outside of the garment on the footprint of the dressing. Through a hook and loop mechanism the dressing is now fully secured in place.
15800224|NCT04449341|Device|Oculus Go headset with Ocean Rift application|Information already included in arm description
15800225|NCT04449328|Device|Computerized Mirror Therapy (CMT)|"Computerized Mirror Therapy (CMT) will be realizing by the device Intensive Visual Simulation 3 (IVS3).
~The patient looks on a screen in front of him, mirroring the movements made by his hand, while attempting to perform the same movement with his other hand."
15800226|NCT04449328|Device|Tendon vibration|Transcutaneous vibrations are used. This device allows vibrations from 50 to 120 Hz with amplitude of 1 mm. This study the frequency used is 70 and 80 Hz.
15800227|NCT04449315|Other|Young Living Lavender Essential Oil|For qualified patients one to two drops of hospital approved essential oil will be placed on a 4X4 gauze and will be offered to the patient during their infusion visit. This gauze will be placed in a sealable clear plastic bag and the patient will be instructed to use one sniff at a time.
15800228|NCT04449302|Procedure|Immediate molar implant with customized healing abutment|"Patients will receive an immediate implant with customized healing abutment
~Atraumatic extraction without flap elevation using periotomes and elevators then sectioning of the roots will be performed to preserve the interseptal bone.
~The drilling will be performed starting from the pilot drill in the interseptal bone to the twisting drills according to the manufacturer's instructions to the selected implant size. The implant is to be placed immediately then the insertion torque will be measured using a torque wrench. In order to place the customized healing abutment, the insertion torque should be more than 25 ncm.
~The gap distance will be filled by xenograft, a plastic abutment will be screwed in place then a flowable composie resin will be applied around into small amounts and cured to take the soft tissue contour then finishing and polishing of the customized healing abutment will be done."
15800229|NCT04449289|Drug|Intravenous lidocaine|Intraoperatively and postoperatively a standard intravenous infusion of lidocaine will be used for analgesia
15800230|NCT04449289|Drug|Epidural ropivacaine|Intraoperatively and postoperatively an epidural infusion of ropivacaine will be used for analgesia
15800233|NCT04449263|Device|Lens A|Subjects will be randomized to wear Lens A (test) for 2 weeks.
15800234|NCT04449263|Device|Lens B|Subjects will be randomized to wear Lens B (control) for 2 weeks.
15800235|NCT04449263|Device|Habitual Lenses|All Subjects will wear their habitual lenses for 2 weeks prior to randomization of test lens and control lens.
15800236|NCT04449250|Drug|Dexmethylphenidate|Subjects will be randomized to one of two sequences. Subjects will be dosed with 50 mg dose of CTx-1301 during each sequence. Subjects will serve as their own control.
15800237|NCT04449237|Other|music therapy|music therapy: therapeutic sound according to the frequency and loudness of each patient's tinnitus sound, so as to reduce the tinnitus sound.
15800238|NCT04449224|Drug|Adalimuab, Etanercept, Tocilizumab, or Abatacept|A specific targeted therapy wil be decided by shared-decision making, a bidirectional process in which clinicians and patients make decisions based on clinical evidence that balances risks and expected outcomes with patient preferences and values.
15800239|NCT04449224|Drug|Tofacitinib or Baricitinib|A specific targeted therapy wil be decided by shared-decision making, a bidirectional process in which clinicians and patients make decisions based on clinical evidence that balances risks and expected outcomes with patient preferences and values.
15800240|NCT04449211|Device|Implantation|Reconstructing the long bone defect with 3D-printed customised Titanium alloy implant
15800241|NCT04449198|Drug|Resveratrol|500 mg of oral trans-resveratrol twice daily (in the morning and evening) for 12-weeks
15800242|NCT04449198|Other|Placebo|placebo for 12 weeks
15800243|NCT04449185|Drug|Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days|Tegoprazan 50mg bid + amoxicillin 1000mg bid + clarithromycin 500mg bid for 10 days
15800244|NCT04449159|Dietary Supplement|Vinh Wellness Collagen|Vinh Wellness Collagen is hydrolyzed collagen
15800245|NCT04449159|Dietary Supplement|Placebo|Placebo
15800246|NCT04449146|Diagnostic Test|Scapular positioning in Standing position using Sonography|The localizer ultrasound of the shoulder is performed in an unclothed patient (at the shoulders) and comes to locate bony landmarks using the ultrasound probe as a Transcutaneous localizer.
15800247|NCT04449133|Drug|AD128|Oral administration of two capsules before sleep for 7 days.
15800248|NCT04449133|Drug|Placebo|Oral administration of two capsules before sleep for 7 days.
15800249|NCT04449120|Behavioral|Mediterranean diet-based culinary intervention|The culinary intervention was developed integrating four culinary workshops that were given every week, once per week, during one-month intervention. The duration of each culinary workshop was 3,5 h, thus, the program provided a total of 14h of practice in cooking activities. The courses took place in a well-equipped kitchen from the Basque Culinary Center. Each culinary workshop was divided in two differentiated parts in order to work on the specific objectives established for each day. All cooking classes began with a theoretical introductory part that aimed to explain the main take-home messages from the workshop. Subsequently, every class was characterized by a hands-on part that included the demonstration and practical preparation of different elaborations based on the use specific cooking techniques and healthy ingredients. At the end of the session, participants were encouraged to taste the prepared meals, to share their preferences and their view about the cooking experience.
15800286|NCT04448782|Diagnostic Test|Asynchronies detection|Asycnhronies detection
15800474|NCT04447196|Other|MDP|Multi dimensional dyspnea profile scores at rest and during non invasive ventilation
15800251|NCT04449107|Behavioral|Android based mobile phone application|An android based mobile application will be developed. The application will have features and capacity for text messages, voice messages, pictorial messages and video messages. The content of the messages will be according to the findings of Paigham e sehat project and the four messages domains would be educational, reminder, religious and adverse effects. In addition, pictorial and video messages would be used as per freely available through EPI programme Pakistan.
15800252|NCT04449081|Behavioral|Knowledge, Attitude, Practice, Awareness, Preference|KAP, Awareness level and Preference were assessed using questionnaires
15800253|NCT04449068|Other|Neurological and neuropsychological Follow-up after deep brain stimulation|Investigation of tic severity, psychiatric co-morbidities, quality of life, and neuropsychologcial measures until the 5-year after deep brain stimulation (DBS)
15800254|NCT04449055|Device|Transcranial Magnetic Stimulation|Participants will undergo 16 treatments consisting of intermittent theta burst stimulation targeting the dorsolateral prefrontal cortex and continuous theta burst stimulation targeting the medial prefrontal cortex, over a 4-week period that coincides with psychosocial treatment for methamphetamine use disorder.
15800256|NCT04449029|Drug|GSK3228836|GSK3228836 will be available as a clear colorless to slightly yellow solution for injection at a unit dose strength of 150 mg/mL to be administered subcutaneously once weekly.
15800257|NCT04449029|Drug|Placebo|Placebo will be available as a clear colorless solution for injection to be administered subcutaneously once weekly.
15800258|NCT04449029|Drug|Nucleos(t)ide therapy|Participants receiving nucleos(t)ide therapy upon entry in the study will continue to receive nucleotide therapy for the duration of the study.
15800259|NCT04449016|Other|High intensity interval training|Repeated, brief, and intense exercise bouts separated by active recovery
15800260|NCT04448990|Device|TENS eco 2 Transauricular vagal nerve stimulation|"Auricular electrical stimulation will be applied bilaterally using Transcutaneous Electrical Nerve Stimulation device TENS eco 2 (Schwa-Medico, Pierenkemper GmbH, Ehringshausen, Germany).
~tVNS will be applied bilaterally using electrical square impulses delivered in blocks of 9 impulses with a frequency of 100 Hz and a pulse width of 200 μs emitted twice per second resulting in mixed frequency pattern of 100 Hz/2 Hz with the current intensity, that will be individually adjusted for each ear separately until the maximal tVNS intensity, which is not uncomfortable or painful, will be achieved."
15800261|NCT04448990|Device|Sham TENS eco 2|Sham
15800262|NCT04448977|Drug|Ocrevus|"Participants with MS will be divided into two treatment groups: those who will begin to take Ocrevus (the early Ocrevus group (EO), and those who plan to be begin treatment with Glatimer acetate SC (Copaxone) (EC). Both groups will be matched to the EO group for age, gender and education. The HC group will be free of neurological disease or injury and will be matched to the EO group for age, gender, and education."
15800263|NCT04448964|Drug|JNJ-70033093|JNJ-70033093 will be administered orally as per assigned treatment sequence.
15800264|NCT04448951|Other|transcriptomics|transcriptomics
15800265|NCT04448951|Other|flow-cytometry|peripheral blood myeloid cells and lymphocytes flow-cytometry
15800266|NCT04448951|Other|cytokines|peripheral blood cytokine analysis
15800267|NCT04448938|Other|MRI|"The MRI examination will be performed on a 3T multi-parametric MRI. Compared to the standard protocol, patients will benefit from an additional sequence of f-mRI, called resting state, and performed before injection of gadolinium contrast agent.
~A consultation with an ophthalmologist will also be carried out the same day, at the Adolphe de Rothschild Foundation.
~The subjects of the control group who agreed to participate will benefit from an MRI examination which will include, in addition to the sequences planned for these patients according to their indications, the two non-injected sequences which will be performed on patients with suspected NO."
15800268|NCT04448938|Other|visual acuity|Patients with NO will be seen in consultation by an ophthalmologist during a follow-up visit approximately 6 months after diagnosis. During this consultation, an OCT, a visual field and the measurement of visual acuity will be performed. This visit and the examinations carried out correspond to the usual care of patients suffering from NO and followed at the Adolphe de Rothschild Foundation Hospital
15800269|NCT04448925|Other|inertial-load exercise (ILE)|Length of time between exercise bouts
15800270|NCT04448912|Procedure|Damage control surgery|Surgery for non-traumatic abdominal emergencies using the damage control approach
15800271|NCT04448912|Procedure|Conventional surgery|Conventional surgery for non-traumatic abdominal emergencies
15800272|NCT04448899|Drug|Ivabradine Oral Tablet|Ivabradine 5 mg twice daily and doses (2.5, 5, 7.5 mg) were to be adjusted upwards or downwards at every visit according to HR at rest and tolerability plus their standard treatment.
15800273|NCT04448899|Drug|Blacebo plus standard treatment|Blacebo plus standard treatment
15800274|NCT04448886|Drug|Pembrolizumab|(iv) fixed dose, administered once per cycle
15800275|NCT04448886|Drug|Sacituzumab Govitecan|(iv) fixed dose, administered twice per cycle
15800276|NCT04448873|Drug|Sirolimus|After at least 2 years of remission of KHE, we compare guided discontinuation with maintenance treatment in pediatric patients with KHE.
15800277|NCT04448860|Behavioral|performance of behavioral locomotion tasks phase 1|The performance of behavioral locomotion tasks is performed on 4 visits on pilot phase (2 in real condition and 2 in virtual reality in D1 and M1)
15800278|NCT04448860|Behavioral|performance of behavioral locomotion tasks phase 2|The performance of behavioral locomotion tasks is performed on 6 visits on validation phase (3 in real condition and 2 in virtual reality in D1, M1 and M12)
15800279|NCT04448847|Dietary Supplement|Bif195|Active trial product with minimum 100 billion CFU daily dose
15800280|NCT04448847|Other|Placebo|Placebo similar to trial product but without Bif195
15800282|NCT04448821|Drug|Metformin|Single administration of metformin
15800283|NCT04448821|Drug|Metformin + Nilotinib|Coadministration of metformin and nilotinib
15800284|NCT04448808|Drug|BX-1|BX-1 (dronabinol), oral solution. All patients enrolled establish their individually tolerable dose by dose Titration.
15800285|NCT04448808|Drug|Placebo|Placebo of BX-1, oral solution
15800287|NCT04448769|Biological|Anti-SARS-CoV-2 IgT seropositivity|"Each inhabitant who agrees to participate will have to :
~sign the consent form after receiving complete information
~complete a questionnaire exploring sociodemographic (gender, age, professional activity...), medical (anthropometric measures, health problems, smoking...), potential contacts with COVID-19 and symptoms.
~take a blood sample for the dermination of anti-SARS-CoV-2 IgT seropositivity of the individuals tested in the population of the Grand Nancy Metropolitan area (GNM)."
15800288|NCT04448756|Drug|M5049|Participants will take M5049 50 milligram (mg) orally twice daily for 14 days.
15800289|NCT04448756|Drug|M5049|Participants will take M5049 100 mg orally twice daily for 14 days.
15800290|NCT04448756|Drug|Placebo|Participants will take placebo tablets matched to M5049 daily for 14 days.
15800291|NCT04448743|Other|Blood sample|20 Ml blood sample
15800292|NCT04448730|Diagnostic Test|serum marker levels|two groups comparisons
15800293|NCT04448717|Diagnostic Test|COVID-19 Antibody testing|COVID-19 Antibody testing in venous blood and/or saliva samples.
15800294|NCT04448691|Diagnostic Test|CCTA|requested follow up CCTA
15800295|NCT04448678|Behavioral|Health Insurance Education Program (HIEP)|[See arm/group descriptions]
15800296|NCT04448678|Other|Usual Care|[See arm/group descriptions]
15800297|NCT04448665|Diagnostic Test|microbiological investigation|a microbiological tests, including isolation of the pathogen and analysis of their susceptibility/resistance to antimicrobial agents
15800298|NCT04448652|Drug|NSAID|no other intervention than described in the groups.
15800299|NCT04448639|Diagnostic Test|Echocardigraphy (ECHO)|Standar 12 lead electrocardiogram
15800300|NCT04448639|Diagnostic Test|Bloodtest|cardiac biomarkers
15800301|NCT04448613|Other|MRI|"Patients with optic disc swelling diagnosed by a fundus and included in the study will have a brain MRI and visual pathways lasting 30 minutes.
~Two additional 10-minute sequences will be added to the standard protocol."
15800302|NCT04448600|Other|MRI|"The patients included in the study will all have a cerebral MRI as part of the cholesteatoma follow-up or for the assessment of cerebral or inner ear pathology.
~- ENT evaluation"
15800303|NCT04448587|Drug|Sitagliptin 100mg|Oral sitagliptin will be commenced at a dose of 100 mg BID. The dose will be increased by 100 mg every three days up to a maximal dose of 300 mg BID. In the case of significant drug related side effects or drug intolerance, the last tolerated dose will be resumed. Patients responding well to lower doses of sitagliptin, will not be given higher doses of the drug. Sitagliptin will be provided as long as deemed effective by the treating physician up to three months.
15800304|NCT04448574|Other|Chest Wall Deformities Questionaire|Questionaire about epidemiological data was sent to Patients and families
15800305|NCT04448561|Drug|ASP8082|oral
15800306|NCT04448561|Drug|morphine|oral
15800307|NCT04448561|Drug|Placebo|oral
15800308|NCT04448548|Other|blood sample taking|For study purposes, blood sample was taken during the first medical examination from patients with suspected infection.
15800309|NCT04448535|Dietary Supplement|Gingko Biloba|oral intake of Gingko Biloba, 240mg/day for 4 weeks
15800310|NCT04448522|Radiation|reduced dosage IMRT|"Gemcitabine plus cisplatin induction chemotherapy: gemcitabine is injected intravenously at the dose of 1000 mg/m2 on the 1st and 8th day (within 30 minutes) for 3 cycles; cisplatin is injected intravenously at the dose of 80 mg/m2 on the 1st day, for 3 cycles. 1 cycles per 3 weeks.
~Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks.
~IMRT: PTVnx：63.6Gy/30Fr/2.12Gy; PTVnd：63.6Gy/30Fr/2.12Gy; PTV1：54Gy/30Fr/1.8Gy; PTV2：49.2Gy/30Fr/1.64Gy"
15800311|NCT04448522|Radiation|conventional dosage IMRT|"Gemcitabine plus cisplatin induction chemotherapy: gemcitabine is injected intravenously at the dose of 1000 mg/m2 on the 1st and 8th day (within 30 minutes) for 3 cycles; cisplatin is injected intravenously at the dose of 80 mg/m2 on the 1st day, for 3 cycles. 1 cycles per 3 weeks.
~Concurrent cisplatin chemotherapy: cisplatin is given at a dose of 100 mg/m2 via a continuous intravenous infusion during radiotherapy and starts on the 1st day of radiotherapy for 2 cycles. 1 cycles per 3 weeks.
~IMRT: PTVnx：69.96Gy/33Fr/2.12Gy; PTVnd：69.96Gy/33Fr/2.12Gy; PTV1：59.4Gy/33Fr/1.8Gy; PTV2：54Gy/33Fr/1.64Gy"
15800312|NCT04448509|Other|Peripheral blood mononuclear cell apheresis|Peripheral blood mononuclear cell collection for tumor immunotherapy study of UCAR-T cells
15800313|NCT04448496|Drug|Dexamethasone implant|Dexamethasone 0.7mg is injected into the vitreous cavity through the pars plana using applicator for diabetic macular edema.
15800314|NCT04448483|Device|Paretic upper limb functional electric stimulation through RehaStim|"The stimulation will activate upper limb muscles to perform motor rehabilitation exercises for the upper limb with the help of the Gloreha Sinfonia robotic glove that will assist-as-needed hands movements. Motor intention will be detected by a BCI (Brain Computer Interface) from the non-invasive measure of brain activity by using electroencephalography.
~The motor rehabilitation exercises include upper limb and hand mobilization and functional tasks, such as hand open/closing, wrist flexion/extension, and reach and grasp a cup, keep and release."
15800315|NCT04448483|Device|Non-invasive transcranial current stimulation through DC-Stimulator|Non-invasive brain stimulation in the form of transcranial direct current stimulation will be provided in addition to the previous intervention.
15800316|NCT04448470|Other|Questionnaire for recording daytime sleepiness over the course of the day|Questionnaire for recording daytime sleepiness over the course of the day
15800317|NCT04448470|Other|Anamnesis and physicial examination|Anamnesis and physical examination, e.g. medication, comorbidities, complaints
15800318|NCT04448470|Other|Questionnaire for quantifying daytime sleepiness|the Epworth Sleepiness Scale (ESS) questionnaire and the STOP BANG Questionnaire
15800319|NCT04448470|Diagnostic Test|Pulmonary function test|The measured values of spirometry/body plethysmography, CO diffusion and blood gas analysis are documented, if available.
15800350|NCT04448171|Device|Sham TENS|Standard TENS unit with four pads affixed to the lower back area, will be used in this arm. The TENS device will be set to an inactive setting.
15800351|NCT04448158|Diagnostic Test|Genotypic Resistance Test|"A Genotypic Resistance Test by Sanger sequencing will be done after the period of virological suppression.
~If M184V is still present no additional test will be performed.
~If M184V is absent, we will go back in the previous samples (one per year) to determine the time point where the mutation has been cleared by sanger and UDS sequencing."
15800320|NCT04448470|Diagnostic Test|Polygraphy|Polygraphy is a non-invasive portable examination method that the patient uses in the home environment at night to measure possible sleep-related breathing disorders. Typically, the following measurement signals are recorded: nasal airflow, thoracic and abdominal breathing excursions, snoring and breathing sounds via a microphone, pulse, oxygen saturation and position. The evaluation results and the findings are checked by a physician. Essential parameters include the apnoea-hypopnoea index, the number of obstructive, central and mixed apnoea/hypopnoea, the number and duration of desaturation, snoring or the association with a certain position.
15800321|NCT04448457|Drug|Sufentanil Sublingual Tablet|15 mcg with lockout interval of 20 min
15800322|NCT04448457|Drug|Oxycodone oral tablet and oxycodone extended-release oral tablet|Oxycodone hydrochloride 5 mg and Oxycodone extended-release 10 mg
15800323|NCT04448444|Behavioral|Motor Program Activating Therapy|Patients undergo ambulatory physiotherapy - Motor Program Activating Therapy (2 months, twice a week, 1 hour of duration). Therapy was undertaken at the ambulatory section of the Department of Neurology, Kralovske Vinohrady University Hospital in Prague.
15800324|NCT04448444|Behavioral|Vojta reflex locomotion|Patients undergo ambulatory physiotherapy - Vojta Reflex Locomotion Therapy (2 months, twice a week, 1 hour of duration). Therapy was undertaken at the Department of Rehabilitation and Sport Medicine, Motol University Hospital.
15800325|NCT04448431|Drug|Vortioxetine|10 or 20 mg/day, capsules, orally
15800326|NCT04448431|Drug|Desvenlafaxine|50 mg/day capsules, orally
15800327|NCT04448418|Other|web based survey|Assess specific health care needs for the transpopulation during the COVID-19 outbreack using a newly created questionnaire and some validated questionnaries (Impact of Event Scale-Revised, BECK Depression Inventory and the Self-rated Health SF-12)
15800328|NCT04448405|Behavioral|Questionnaire for evaluation of confinement on deviant sexual fantasies|Questionnaire for evaluation of confinement on deviant sexual fantasies. Population already followed for deviant fantasies
15800329|NCT04448392|Drug|Valacyclovir|Upon completion of standard of care acyclovir for treatment of neonatal HSV disease, valacyclovir oral suspension (per ASHP recipe), 20 mg/kg every 8 hours, to be given for 2 (up to 7) days
15800330|NCT04448379|Drug|JMT101|IV infusion Q2W for 4 weeks (28-day cycles)
15800331|NCT04448366|Behavioral|Cognitive behavioral therapy|Patients in the CBT group will receive usual care. In addition, they will undergo one pre-surgery and six post-surgery face-to-face sessions of CBT. In the pre-surgery session, management of expectations towards surgery will be addressed. In the six post-surgery sessions, attention will be paid to psycho-education concerning the biological link between endometriosis-related pain and stress, relaxation training, cognitive stress management, and management of anxiety, catastrophizing and hypervigilance. The CBT sessions will be coordinated by a registered psychotherapist who is experienced in CBT and has knowledge about endometriosis. All CBT will be individual sessions.
15800332|NCT04448353|Diagnostic Test|vascuCAP|adverse event and phenotype classification model
15800333|NCT04448340|Diagnostic Test|machine learning model|Two classification algorithms, logistic regression and K-Nearest Neighbors (K-NNs), were investigated for their ability to predict successfully whether patients suffered from PDD or DLB.
15800334|NCT04448327|Device|active tVNS|non-painful electrical stimulation of the auricle for 30 minutes during a functional magnetic resonance imaging session
15800335|NCT04448327|Device|Sham tVNS|Sham stimulation of the auricle for 30 minutes during a functional magnetic resonance imaging session
15800338|NCT04448288|Other|Static stretching|Static stretchings were performed by subjects that involved varied repetitions of 30-s static-stretches and 20-s relax period.
15800339|NCT04448275|Other|Neurodynamics Nerve flossing|"Neurodynamics Nerve flossing for femoral nerve that includes two techniques inform of:
~slider technique and the second is the tensioner technique"
15800340|NCT04448275|Other|conventional selected exercise program|Ultrasound therapy The flexibility exercises for iliopsoas & quadriceps The iliopsoas & quadriceps muscles strength exercise
15800341|NCT04448262|Other|data collection|collection of data about bronchial and systemic inflammation, quality of life, lung function
15800342|NCT04448249|Behavioral|APN intervention|"APN intervention is divided into five main steps:
~clinical and paraclinical examinations,
~appraisal of patient's knowledge,
~health education on hypertension and treatments,
~setting a written medication plan with the patient to invest him in his management with adjusting or renewing treatments identically if necessary,
~decision-making balance between the benefits and risks of non-adherence to medication. A time is scheduled at the end of the intervention to let the patient ask questions or express his difficulties if he needs to."
15800343|NCT04448236|Device|Blood flow restriction resistance exercise|"Application the Blood flow restriction device over the proximal thigh to have 80% of the limb occlusion pressure to accumulate the metabolite generated during knee extension"
15800344|NCT04448223|Drug|CKD-351|Latanoprost (25ug/ml), Dorzolamide (20mg/ml), twice a day
15800345|NCT04448223|Drug|Latanoprost+Dorzolmamide|Latanoprost(50ug/ml) , once a day Dorzolmamide(20mg/ml), threetimes a day
15800346|NCT04448210|Behavioral|DigiKnowIt News: Teen|Teens will interact with a multimedia educational website that will teach them about pediatric clinical trials including topics such as participant rights and safety, benefits and costs to participating in a study, and different types of procedures used in trials.
15800347|NCT04448197|Other|Chinese Medicine|Dialectical treatment of traditional Chinese medicine according to different constitution
15800348|NCT04448184|Drug|Tranexamic Acid|"Patients allocated to the prophylactic Tranexamic Acid group will receive a standardized routine oral or intravenous dose of Tranexamic Acid 1 gram three times daily.
~Tranexamic Acid will start when Platelet count is less than 50 x 109/L and continue until platelet engraftment. Patients in this group will not receive routine prophylactic platelet transfusions. Subjects unable to swallow oral Tranexamic Acid pills may have the tablets crushed, administered via nasogastric (NG) tube or the medication will be administered intravenously."
15800349|NCT04448171|Device|Active TENS|Standard TENS unit with four pads affixed to the lower back area, will be used in this arm. The TENS device will be set to an active setting.
15800352|NCT04448132|Biological|IPV-Al|adjuvanted reduced dose inactivated polio vaccine
15800353|NCT04448119|Drug|Favipiravir|Favipiravir is the experimental drug. The dosage for favipiravir to be used in this study for prophylaxis is 1600 mg (8 x 200 mg tablets) orally twice daily on day 1 followed by 800 mg (4 x 200 mg tablets) orally twice daily on days 2-25. The dose of favipiravir for treatment is 2000 mg orally twice daily on day 1, the 1000 mg orally twice daily for 13 additional days.
15800354|NCT04448119|Drug|Favipiravir Placebo|Favipiravir Placebo is the placebo drug. For chemoprophylaxis, the dosage of favipiravir placebo is 8 tablets orally twice daily on day 1, followed by 4 tablets twice daily from days 2-25. The dosage of favipiravir placebo for treatment is 10 tablets orally twice daily on day 1, followed by tablets twice daily from days 2-14.
15800355|NCT04448106|Biological|Celltex- AdMSCs|Autologous adipose-derived stem cells Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue
15800356|NCT04448093|Procedure|dental treatment|Dental treatment of adequacy of oral environment and assessment of quality of life and self-esteem through questionnaires comparing a group that received treatment with another that did not.
15800357|NCT04448080|Device|Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT)|Intraocular pressure will be lowered by Micropulse Transscleral Laser Therapy for Glaucoma (MP-TLT) in patients with a diagnosis of glaucoma
15800358|NCT04448067|Behavioral|Dietary Lentil Intake|Dietary intake of moderate or high dose of lentils at midday meals
15800359|NCT04448067|Behavioral|No Dietary Lentil CONTROL|Dietary intake of meals without lentils and matched to dietary lentil meals for total energy and protein
15800360|NCT04448054|Other|MRI|"Case 1: Routine care protocol not requiring injection
~Realization of the non-injected MRI protocol adapted to the indication
~+ Addition of a 3D bFFE-Xd sequence (+ 2 min) The protocol will last the examination time usually provided by the current treatment according to the indication + 2 min of complementary sequence Case 2: Routine treatment protocol requiring an injection
~Realization of the injected MRI protocol adapted to the indication
~Before gadolinium injection:
~Addition of a 3D bFFE-Xd sequence (+ 2 min) before injection
~After gadolinium injection:
~Option 1: if olfaction disorder, addition of DCE perfusion sequence (T1-WI) which will be the 1st post injection sequence (+ 4 min 30)
~FABIR 0.9 3D sequence (+ 4 min)
~3D sequence T1 TSE 0.7 (+ 2 min 30)
~FLAIR HR coronal sequence (+ 3 min 30)
~Option 2: if hearing / balance disorder, adding 3D FLAIR labyrinth sequence (+ 6min) which will be the 1st post injection sequence"
15800361|NCT04448041|Other|Malnutrition screening|Primary comparison: Prevalence of malnutrition and impact on 30-day outcomes in patients undergoing surgery for cancer
15800362|NCT04448028|Drug|Placebo|Patients with a pre-existing PPI therapy discontinue PPI therapy and replace it with placebo over a period of 346 days after a 14 day dose tapering phase.
15800363|NCT04448028|Drug|Esomeprazole 20mg|Patients with a pre-existing PPI therapy stop their prior PPI medication and have it replaced with esomeprazole 20mg/day for 360 days.
15800364|NCT04448015|Other|Perinatal Opioid Use Disorder Education and Enhanced Perinatal Care|University of Utah clinicians will provide face-to-face, online, and written training materials for health, mental health, and substance use service providers in Carbon and Emery Counties, UT.
15800365|NCT04448002|Behavioral|AIM2ACT|AIM2ACT is a mobile health tool that is designed to facilitate collaborative asthma management between early adolescents and their caregivers. AIM2ACT contains the following components: 1) ecological momentary assessment to identify personalized strengths and weaknesses in asthma self-management behaviors; 2) collaborative identification and tracking of goals that help early adolescents to become increasingly independent in managing their asthma; and 3) a suite of engaging skills training videos to help dyads understand how to use AIM2ACT and work together to set asthma self-management goals, develop and achieve the goals articulated in a behavioral contract, and engage in problem-solving communication.
15800366|NCT04448002|Behavioral|mHealth Attention Control Condition|Dyads in the mHealth attention control condition will not receive personalized asthma management feedback, will not be guided through collaborative identification and tracking of asthma self-management goals, and will not have access to skills training videos. Instead, dyads will receive static educational information on their smartphones about behavioral management techniques they can use to target improving asthma self-management.
15800367|NCT04447989|Drug|Sildenafil|Sildenafil citrate injection or powder for suspension
15800368|NCT04447989|Drug|Placebo|dextrose 5%
15800369|NCT04447963|Device|Non-invasive treatment of facial wrinkles|Application of radiofrequency field which provides controlled heating to the skin.Therapeutic effect is observed when the tissue temperature reaches 40-45 degrees Celsius.
15800370|NCT04447950|Procedure|Type 2/posterior Quadratus Lumborum block|Injection of local anaesthetic into posterior boundry of Quadratus Lumborum muscle.
15800371|NCT04447950|Procedure|Placebo block with Saline|Injection of saline into posterior boundary of Quadratus Lumborum muscle.
15800372|NCT04447937|Other|No Interventions|There are no interventions associated with the study.
15800373|NCT04447924|Dietary Supplement|Bif195|Daily intake of Bif195 dietary supplement
15800374|NCT04447924|Other|Placebo|Daily intake of Placebo
15800375|NCT04447911|Drug|Empagliflozin 25 MG|Empagliflozin 25mg per os once daily for 30 days
15800376|NCT04447911|Drug|Placebo|Placebo per os once daily for 30 days
15800377|NCT04447898|Drug|PPV-06 10 μg|Low dose + Montanide™ ISA 51 VG in SC administration = 3 injections on Day 0, Day 28, and Day 112
15800378|NCT04447898|Drug|PPV-06 50 μg|High dose+ Montanide™ ISA 51 VG in SC administration = 3 injections on Day 0, Day 28, and Day 112
15800379|NCT04447898|Drug|Placebo|Placebo+ Montanide™ ISA 51 VG in SC administration = 3 injections on Day 0, Day 28, and Day 112
15800380|NCT04447885|Device|weighted blanket|A weighted blanket is a blanket with extra weight sewn in for added pressure to the body.
15800381|NCT04447872|Procedure|Timing of injectable gonadotropins|Gonadotropins will with be started in the luteal phase or in follicular phase (preceded by Estradiol patches)
15800382|NCT04447859|Drug|Semaglutide|Slow semaglutide titration group vs. label recommended titration group (16-week flexible vs. 8-week semaglutide titration)
15800383|NCT04447859|Other|label recommended titration|label recommended titration
15800384|NCT04447846|Drug|Cannabidiol|Initiation of treatment will begin with 5 mg/kg/day given in two divided doses. The dose will be increased by 5 mg/kg/day after seven days and then by 5 mg/kg/day every seven days up to a maximum dose of 20 mg/kg/day given.
15800385|NCT04447833|Drug|Mesenchymal Stromal Stem Cells - KI-MSC-PL-205|Allogeneic bone marrow derived mesenchymal stromal stem cells (MSCs).
15800389|NCT04447807|Behavioral|Metacognitive Training|MCT is a structured, interactive approach that addresses cognitive biases, social cognition, and self-esteem. This study will conducted this intervention using group format, on a weekly basis, with duration of 8 weeks total.
15800390|NCT04447807|Other|Treatment as Usual|Patients will continue to receive medical attention in the Bipolar Disorder Program -PROMAN- part of the University of São Paulo Medical School.
15800391|NCT04447794|Behavioral|Step Away Chatbot|"The Step Away chatbot utilizes AI technology to provide mobile, web-based, person-centered, behavioral-based interventions and timely support for individuals seeking to reduce their alcohol use. Participants interact with the chatbot through interactive text.
~The Step Away chatbot is informed by the following theoretical constructs: (1) motivational enhancement; (2) relapse prevention; and (3) community reinforcement. It uses the Relapse Prevention (RP) model, which is informed by cognitive behavioral theory and has evolved to reflect the dynamic, non-linear relationships between contextual triggers and coping, as mediated by motivation, mood, and self-efficacy. It proactively encourages the user to identify and include supportive others in treatment; to identify and plan non-drinking, recreational activities; and to develop other non-drinking lifestyle skills and strategies."
15800392|NCT04447794|Behavioral|Step Away App|"The Step Away app is a smartphone-based mobile intervention system.
~It is informed by three theoretical constructs that are considered the most important active ingredients for person-centered, behavioral-based intervention and treatment in addictions: (1) motivational enhancement; (2) relapse prevention; and (3) community reinforcement. Step Away uses the Relapse Prevention (RP) model, which is informed by cognitive behavioral theory and has evolved to reflect the dynamic, non-linear relationships between contextual triggers and coping, as mediated by motivation, mood, and self-efficacy. Step Away proactively encourages the user to identify and include supportive others in treatment; to identify and plan non-drinking, recreational activities; and to develop other non-drinking lifestyle skills and strategies."
15800393|NCT04447781|Biological|INO-4800|- Manufacturer: Inovio Pharmaceuticals Inc.
15800394|NCT04447781|Device|CELLECTRA® 2000|- Manufacturer: Inovio Pharmaceuticals Inc.
15800395|NCT04447781|Other|Saline-sodium citrate (SSC) buffer|- Manufacturer: Inovio Pharmaceuticals Inc.
15800396|NCT04447768|Drug|Obinutuzumab|"Cycle 1, Day 1- 100 mg
~Cycle 1, Day 2 - 900 mg
~Cycle 1, Day 8 - 1000 mg
~Cycle 1, Day 15 -1000 mg
~Cycle 2, Day 1 to Cycle 6, Day 1- 1000 mg"
15800397|NCT04447768|Drug|Venetoclax|"Cycle 1, Day 22 to 28 -20 mg daily
~Cycle 2, Day 1 to Day 7 -50 mg daily
~Cycle 2, Day 8 to Day 14- 100 mg daily
~Cycle 2, Day 15 to Day 21- 200 mg daily
~Cycle 2, Day 22 to Day 28 - 400 mg daily
~Cycle 3, Day 1 to end of Cycle 12-24 - 400 mg daily"
15800398|NCT04447755|Drug|Lenvatinib|Lenvatinib capsules administered orally at 14 mg/m^2 QD
15800399|NCT04447729|Drug|fremanezumab|Two doses, each dose consists of 4 injections with prefilled syringes
15800400|NCT04447716|Drug|Venetoclax|Given PO
15800401|NCT04447716|Drug|Lenalidomide|Given PO
15800402|NCT04447716|Biological|Rituximab|Given IV
15800403|NCT04447716|Biological|Rituximab and Hyaluronidase Human|Given SC
15800404|NCT04447703|Other|Interview|Attend Interview
15800405|NCT04447703|Other|Internet Based Intervention|Use web-based genetic education tool online
15800406|NCT04447703|Other|Survey Administration|Ancillary Studies
15800407|NCT04447703|Other|Genetic Counseling|Receive in-person, telehealth, or over-the-phone genetic counseling
15800408|NCT04447703|Genetic|Genetic Testing|Undergo genetic testing
15800409|NCT04447703|Other|Survey Administration|Ancillary Studies
15800410|NCT04447703|Other|Genetic Counseling|Receive in-person, telehealth, or over-the-phone genetic counseling
15800411|NCT04447703|Other|Internet-Based Intervention|Use web-based genetic education tool online
15800412|NCT04447703|Genetic|Genetic Testing|Undergo genetic testing
15800413|NCT04447703|Other|Survey Administration|Ancillary Studies
15800414|NCT04447664|Device|Inclouded telespirometry system|Components of the system: Portable digital ultrasonic spirometer (Uscom SpiroSonic MOBILE), android mobile application, clinical web cloud application
15800416|NCT04447638|Procedure|Tracheostomy with aerosol box in COVID-19 positive patients|Patients who underwent percutaneous tracheostomy with aerosol box in COVID-19 positive patients. The patients age, gender, hospitalization diagnosis, number of intubated days, anesthetic agents used during the procedure, neck ultrasonography data before and during the procedure, and complications were recorded.
15800417|NCT04447625|Drug|Oral antibiotic administration|per os antibiotic administration as the standard line of strategy for treating CE of doxycycline at a dosage of 100mg twice a day for 14 days and metronidazole of 500mg twice a day for 14 days
15800418|NCT04447625|Drug|Intrauterine antibiotic infusion|intrauterine infusion of 3ml of ciprofloxacin at a concentration of 200 mg/100 ml
15800419|NCT04447612|Drug|Durvalumab|Intravenous infusion of durvalumab 1500mg every 4 weeks for 13 cycles (1 year), starting 1 week before start of induction chemotherapy
15800420|NCT04447612|Drug|Cisplatin|Induction phase: cisplatin 100mg/m2 on day 1 via intravenous infusion every 3 weeks for 3 cycles Concurrent phase: cisplatin 100mg/m2 starting on day 1 of radiation therapy via intravenous infusion every 3 weeks for 3 cycles
15800421|NCT04447612|Drug|Gemcitabine|Induction phase: gemcitabine 1000mg/m2 on day 1 and day 8 via intravenous infusion every 3 weeks for 3 cycles
15800422|NCT04447599|Other|photography of conjunctival vessels|patient will have photo of their bulbar conjunctival of each eye and photography of fundus without dilatation
15800423|NCT04447586|Other|Pressure measurement during exhalation through a device consisted of a drinking straw of an inner diameter of 5mm, a disposable mouthpiece and a manometer|"Participants performed exhalation attempts through a device consisted of a drinking straw of an inner diameter of 5mm, a disposable mouthpiece and a manometer, following the instructions of Command A and B (A:please blow continuously so that you feel low resistance during exhalation and B:please blow continuously so that you feel moderate resistance during exhalation) in a specific order for each group. Every volunteer performed 3 attempts for each command.The outputs of the 3rd attempt were used to the study."
15800475|NCT04447183|Drug|Recombinant Human Thyroid Stimulating Hormone for Injection(rhTSH)|rhTSH: 0.9 mg IM daily on two consecutive days;radioactive iodine: 30mCi±1.5mCi or 1.11GBq of 131I oral
15800424|NCT04447586|Other|Pressure measurement during exhalation through an alternative PEP device/soft drink straw.|"Participants were requested to exhale as indicated by the right command (Command A or B), for 3 sets of 10 repetitions. This procedure included short breaks between sets."
15800425|NCT04447573|Biological|BCMA CAR-T|Biological: BCMA CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;
15800426|NCT04447560|Procedure|Erector Spinae Plane Block|One researcher will record the artery images as explained in the protocol and two researchers will measure the radius and area of those vessels separately. Researchers who are measuring the radius and area of vessels won't know whether those images belong to pre or post- ESP block. The results two researchers measure will be compared statistically and if there are no statistically significant differences, the mean value of their separate recordings will be taken into account for the statistical analysis.
15800427|NCT04447547|Biological|CD19 CAR-T|Biological: CD19 CAR-T; Drug: Cyclophosphamide,Fludarabine; Procedure: Leukapheresis;
15800428|NCT04447534|Drug|Chloroquine|Chloroquine
15800429|NCT04447534|Drug|zinc|Zinc tablets
15800430|NCT04447508|Behavioral|Participants receive one on one motivational interviewing and participate in a group exercise class virtually.|Participants have one group exercise class over zoom per week and an online one on one motivational interviewing session every second week.
15800431|NCT04447495|Diagnostic Test|iAMP test|The low-cost Atila BioSystems iAMP® COVID-19 Detection kit consists of a reaction buffer mix, primer mix, three sample buffer components, a positive and negative control, nasopharyngeal swabs, and sample collection vials. Each kit is suitable for 100 tests.
15800432|NCT04447482|Device|ENB with image-guided lung biopsy|Electromagnetic navigational bronchoscopy system with tip tracked instruments.
15800433|NCT04447482|Procedure|Conventional Bronchoscopy guided by Fluoroscopy|Bronchoscopic lung biopsy with fluoroscopy.
15800434|NCT04447469|Drug|mavrilimumab|anti-granulocyte-macrophage colony-stimulating factor receptor alpha (GM-CSF-Rα) monoclonal antibody (human isoform immunoglobulin G [IgG4])
15800435|NCT04447469|Other|Placebo|matching placebo
15800436|NCT04447443|Dietary Supplement|Prebiotic Fiber Supplement + loperamide hydrochloride capsule|"2-week sequential supplementation with prebiotic fiber supplement (3.5g, twice a day).
~The initial dose of loperamide hydrochloride capsules is 4 mg (2 capsules) followed by 2 mg/4 h if diarrhea persists."
15800437|NCT04447443|Dietary Supplement|Maltodextrin + loperamide hydrochloride capsule|"2-week sequential supplementation with placebo of of maltodextrin (3.5g, twice a day).
~The initial dose of loperamide hydrochloride capsules is 4 mg (2 capsules) followed by 2 mg/4 h if diarrhea persists."
15800438|NCT04447430|Device|bright light|treat patients with bright light, 30 min per day, 7 times per week, over 6 weeks
15800439|NCT04447430|Device|dim red light|treat patients with dim red light, 30 min per day, 7 times per week, over 6 weeks
15800440|NCT04447417|Drug|Dupilumab SAR231893|Pharmaceutical form:solution for injection Route of administration: subcutaneous
15800441|NCT04447404|Drug|DUR-928|IV infusion
15800442|NCT04447404|Drug|Placebo|IV infusion
15800443|NCT04447391|Other|Combined exercise program|Combined exercise programme, consisting of warm-up, aerobic exercise, resistance training, and cool-down, 3 days a week after school for 50 minutes from 17;30 under supervision by a trainer plus 300 kcal deficit diet
15800444|NCT04447391|Other|Control|300 kcal deficit diet only
15800445|NCT04447378|Drug|Fondaparinux 2.5Mg/0.5Ml Inj Syr|post natal thromboprophylaxis
15800446|NCT04447365|Diagnostic Test|device interrogation|All patients will have a pre-existing ICD and a diagnosis of cardiomyopathy with left ventricular systolic function of 35% or less by echocardiogram done within 1 year of the time of enrollment.
15800447|NCT04447352|Drug|5-Fluorouracil|Day 1 q2w: 2600 mg/m² IV over 24 hours
15800448|NCT04447352|Drug|Leucovorin|Day 1 q2w: 200 mg/m² IV over 30 minutes
15800449|NCT04447352|Drug|Oxaliplatin|Day 1 q2w: 85 mg/m² IV over 2 hours
15800450|NCT04447352|Drug|Docetaxel|Day 1 q2w: 50 mg/m² IV over 1 hour
15800451|NCT04447352|Drug|Cisplatin|intraoperative: 75mg/m² intraabdominal solution over 1 hour and 30 minutes
15800452|NCT04447339|Procedure|Nipple Sparing Mastectomy|Prophylactic open NSM procedures
15800453|NCT04447326|Drug|Toripalimab, Endostar Combined With Radiotherapy and Chemotherapy|Toripalimab: 240 mg, Q3W, starting on D1, for totally 12 cycles Endostar: 7.5 mg/m2/d, continuous intravenous pumping for 10 days, Q3W, starting on D1, for totally 5 cycles
15800454|NCT04447326|Drug|IC＋CCRT|IC＋CCRT
15800455|NCT04447313|Other|Survey Administration|Ancillary studies
15800456|NCT04447313|Behavioral|Telephone-Based Intervention|Receive ACT telephone coaching
15800457|NCT04447313|Behavioral|Telephone-Based Intervention|Receive SBT telephone coaching
15800458|NCT04447300|Procedure|high power application|Radiofrequency delivery was performed in a point-by point fashion and continuously (an inter-lesion distance of 6 mm) with 50 W and 70 W and the ablation time for each point is limited to 7s and repeated if needed till the Unipolar signal modification turn to complete positive R wave.
15800459|NCT04447300|Procedure|Standard power application|Standard power application
15800460|NCT04447287|Drug|ASP8062|Oral
15800461|NCT04447287|Drug|Placebo ASP8062|Oral
15800462|NCT04447287|Drug|buprenorphine/naloxone|Sublingual
15800463|NCT04447274|Drug|Camrelizumab and Apatinib|Subject will receive SHR-1210 200mg every 2 weeks, with intravenous drip Apatinib 425 mg, oral, 5 consecutive days, 2 days off,each 14 day of a cycles
15800464|NCT04447261|Drug|BI 1356225|BI 1356225
15800465|NCT04447261|Drug|Placebo|Placebo
15800466|NCT04447248|Device|QDSP Protocol|Computerized expert system for fetal monitoring, based on cardiotocogrpaphy
15800467|NCT04447235|Drug|Placebo|Use of the combination of ivermectin-placebo plus losartan-placebo as early treatment for COVID-19 in cancer patients
15800468|NCT04447235|Drug|Ivermectin|Use of the combination of ivermectin plus losartan as early treatment for COVID-19 in cancer patients
15800469|NCT04447235|Drug|Losartan|Use of the combination of ivermectin plus losartan as early treatment for COVID-19 in cancer patients
15800470|NCT04447222|Other|Quality-of-Life Assessment|Ancillary studies
15800471|NCT04447222|Other|Questionnaire Administration|Ancillary studies
15800472|NCT04447222|Other|Survey Administration|Complete survey
15800477|NCT04447170|Procedure|Simple repair or Graham technique|Simple suture with or without omental protective patch
15800478|NCT04447131|Other|venipuncture in peripheral vein|single vacuum venipuncture in peripheral vein
15800481|NCT04447105|Drug|total intravenous anesthesia with propofol|In the TIVA group, general anesthesia is induced and maintained with a target-controlled infusion of propofol using infusion pump (Orchestra®; Fresenius Vial, Brezins, France). In both groups, remifentanil is continuously infused throughout the surgery for balanced anesthesia, adjusted to maintain arterial pressure.
15800482|NCT04447105|Drug|inhalation anesthesia with desflurane|In the desflurane group, anesthesia is induced with propofol 1-2 mg/kg and maintained with desflurane (5-7 vol %). In both groups, remifentanil is continuously infused throughout the surgery for balanced anesthesia, adjusted to maintain arterial pressure.
15800483|NCT04447092|Drug|Gemcitabine|Gemcitabine 1000 mg/m2 iv D1, 8, 15 (every 4 weeks)
15800484|NCT04447092|Drug|Nab-paclitaxel|Nab-paclitaxel 125 mg/m2 iv D1, 8, 15 (every 4 weeks)
15800485|NCT04447092|Drug|Pembrolizumab|Pembrolizumab ( 200 ) mg iv D1 (every 3 weeks)
15800486|NCT04447092|Drug|Oxaliplatin|Oxaliplatin 65 mg/m2 iv over 2 hours D1 (every 2 weeks)
15800487|NCT04447092|Drug|Leucovorin|Leucovorin 400 mg/m2 iv D1 (every 2 weeks)
15800488|NCT04447092|Drug|Irinotecan|Irinotecan 140 mg/m2 iv over 1.5 hours D1 (every 2 weeks)
15800489|NCT04447092|Drug|5FU|5-FU 2400 mg/m2 iv over 46 hours D1 (every 2 weeks)
15800490|NCT04447079|Behavioral|Assertive Community Treatment (ACT)|"Assertive Community Treatment (ACT) is part of a 6-month program ARFAs will undergo.
~ACT teams will engage with ARFAs on a dedicated schedule. Each visit would last an average of 60 minutes. There will not be a re-arrangement of no-show visits. ACT teams will re-engage the ARFA over the phone to plan for the next visit as per the schedule.
~In keeping with principles of ACT, ARFA's will be assertively sought out in the community and provided intensive engagement, with holistic and supportive care alongside a harm reduction approach. Care will also involve case management and involvement of SSA's.
~Each interaction during the treatment period will focus on various aspects covering physical health, mental health, and addiction"
15800491|NCT04447066|Other|No intervention|No intervention - VHIT will be used but without intervention
15800492|NCT04447053|Drug|Belimumab Injection [Benlysta]|Belimumab, IV infusion, 10mg/kg on days 0, 14, 28 then every 28 days until week 48.
15800493|NCT04447040|Drug|Acetaminophen/naproxen sodium Dose A|Acetaminophen/naproxen sodium Dose A administered as a single two-tablet dose.
15800494|NCT04447040|Drug|Acetaminophen/naproxen sodium Dose B|Acetaminophen/naproxen sodium Dose B administered as a single two-tablet dose.
15800495|NCT04447040|Drug|Acetaminophen/naproxen sodium Dose C|Acetaminophen/naproxen sodium Dose C administered as a single two-tablet dose.
15800496|NCT04447040|Drug|Acetaminophen/naproxen sodium Dose D|Acetaminophen/naproxen sodium Dose D administered as a single two-tablet dose.
15800497|NCT04447040|Drug|Acetaminophen/naproxen sodium Dose E|Acetaminophen/naproxen sodium Dose E administered as a single two-tablet dose.
15800498|NCT04447040|Drug|Placebo|Placebo tablets administered as a single two-tablet dose.
15800499|NCT04447027|Drug|Romidepsin|Romidepsin (12mg/ m2 ) will be administered on days 1 and 10 of each cycle through a peripheral or central intravenous catheter for 6 cycles.
15800500|NCT04447027|Drug|Lenalidomide|Lenalidomide will be administered by oral intake in a dose-escalation with a starting dose of 5mg daily, a second dose level of 10mg daily, a third dose level at 15mg daily, and a fourth dose level at 20mg daily on days -7 to day 10 of first cycle. After the second cycle, lenalidomide will be given from day 1 to day 10 in each cycle for up to 6 cycles.
15800501|NCT04447027|Drug|CC-486 (5-azacitidine)|CC-486 (5-azacitidine) with a dose of 300mg oral intake daily will be given on day 1 to day 10 for 6 cycles.
15800502|NCT04447027|Drug|Dexamethasone|Dexamethasone, 40mg, PO, will be given on days 1 and 10 of each cycle.
15800503|NCT04447001|Behavioral|Tai-chi prime (TCP)|TCP is a 6-week twice-weekly simplified tai chi class of 1.5 hr per session with two components: (a) Tai-chi fundamental Adapted Program, and (b) home practice coaching.
15800504|NCT04446988|Device|Sacroiliac joint injection|Injection of sacroiliac joint with local anesthetic and steroid
15800505|NCT04446975|Other|BPA|At the time of writing the prescription an automatic notification will appear on the care provider's screen that identifies a suggested post-discharge opioid dose within the electronic prescription pad. If approved by the provider, opioid-only prescriptions will be written as suggested. Final dosing decisions and drug choices will remain at the discretion of the treating provider.
15800506|NCT04446962|Drug|Lenalidomide|Patients will receive 4 cycles of induction chemotherapy with R-MPV + Lenalidomide using the Maximum Tolerated Dose (MTD) of Lenalidomide and Ibrutinib as determined in the phase-Ib part of the study.
15800507|NCT04446962|Drug|Ibrutinib|Patients will receive 4 cycles of induction chemotherapy with R-MPV + Ibrutinib, using the Maximum Tolerated Dose (MTD) of Lenalidomide and Ibrutinib as determined in the phase-Ib part of the study.
15800508|NCT04446949|Other|Register follow-up|Number of adverse pregnancy outcomes
15800509|NCT04446936|Procedure|Flap covering for pressure ulcer|Flap covering for pressure ulcer
15800510|NCT04446923|Drug|Hand antisepsis by scrub|Surgical Hand scrubbing using P-1 of both hands using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side.
15800511|NCT04446923|Drug|Hand antisepsis by scrub|Surgical Hand rubbing using P-1 of both hands using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side.
15800512|NCT04446910|Behavioral|SMS Text Messaging|SMS text messaging intervention for a period of 90 days to promote attendance at community-based substance use or dual diagnosis treatment appointments through motivational messages.
15800513|NCT04446910|Behavioral|Standard of Care Engagement Practices|Standard of care engagement practices, such as communicating with youth and caregivers, as needed, through texting but frequency of contact and content of messaging varies according to individual needs.
15800515|NCT04446897|Other|standard treatment|standard treatment according to clinical protocols
15800516|NCT04446884|Biological|Autologous adipose-derived mesenchymal stem cells|Autologous adipose-derived mesenchymal stem cells mixed with collagen solution
15800517|NCT04446884|Other|Standard treatment according to the Clinical protocols|Standard treatment according to the Clinical protocols
15800518|NCT04446871|Drug|0.9% sodium chloride|Intravenous infusion of 500 cc of 0.9% sodium chloride solution for 6 h, once a day for a total of 3 doses.
15800519|NCT04446871|Drug|Methylene Blue|Intravenous infusion of 100 mg methylene blue in 500 cc of 0.9% sodium chloride solution for 6 h, once a day for a total of 3 doses.
15800520|NCT04446845|Drug|Double Stimulation (Elonva+rFSH) in luteal /follicular phase|Following the 2nd oocyte retrieval, the patient will start luteal phase support (LPS) with vaginal micronized progesterone 200mg x 3 times a day until the day of the pregnancy test. All embryos will be cultured until day 5 in time-lapse incubators. In case of no blastocyst in the second cycle, or in case of poor embryo quality and in case of availability of frozen embryos from the first stimulation cycle, 1 frozen blastocyst from the first cycle will be thawed and will be transferred 5 days following the 2nd oocyte retrieval. Embryo transfer will be performed in all patients with available blastocysts, except in cases of high risk of ovarian hyperstimulation syndrome (OHSS) or progesterone elevation which is considered clinically relevant on the day of human chorionic gonadotropin (hCG) trigger, in which freeze-all strategy and deferred frozen embryo transferred will be considered.
15800521|NCT04446845|Drug|Conventional Stimulation (Elonva+rFSH) in follicular phase|From the day of oocyte retrieval, the patients will be asked to start the LPS with vaginal micronized progesterone 3 times a day until the day of the pregnancy test. Embryo transfer will be performed in all patients with available blastocysts, except in cases of high risk of OHSS or progesterone elevation which is considered clinically relevant on the day of hCG trigger, in which freeze-all strategy and deferred frozen embryo transferred will be considered.
15800522|NCT04446832|Other|Vaccine immunogenicity|Evaluation of the vaccine immunogenicity by standard approved serological tests
15800523|NCT04446819|Device|Compression gloves|Patients wear small-size compression gloves (one or two size smaller than suitable size) for dominant hands and suitable-size compression gloves for non-dominant hands for 90 minutes during the administration of albumin-binding paclitaxel (start from 30 minutes before albumin-binding paclitaxel infusion).
15800524|NCT04446806|Drug|Ruxolitinib|Ruxolitinib as second treatment in patients with severe DS failed in responding to hormone.Furthermore
15800525|NCT04446793|Drug|Onvansertib|15 mg/m^2 will be administered orally on Day 1 to Day 5 of every 14 day treatment course. There will be two 14-day courses of treatment in each 28 day cycle.
15800526|NCT04446793|Biological|Bevacizumab|5 mg/kg will be administered intravenously on Day 1 of every 14 day treatment course. There will be two 14-day courses of treatment in each 28 day cycle.
15800527|NCT04446793|Drug|FOLFIRI|FOLFIRI (180 mg/m^2 irinotecan, 400 mg/m^2 leucovorin, 400 mg/m^2 bolus 5-fluorouracil [5-FU], and 2400 mg/m^2 continuous intravenous infusion 5-FU over 46 hours) will be administered intravenously on Day 1 of every 14 day treatment course. There will be two 14-day courses of treatment in each 28 day cycle.
15800528|NCT04446780|Procedure|Mediolateral episiotomy|Cutting of the perineum during vaginal delivery in order to avoid obstetric anal sphincter injury
15800529|NCT04446767|Radiation|polarized light|bioptron light therapy sessions, about 12 minutes on the foot ulcer 3 sessions per week for about 8 weeks
15800530|NCT04446767|Other|Medical Care|Appropriate day-care and principles of local ulcer therapy, washing and bandaging, use of anti exudative, anti-inflammatory and disinfection solutions will be administered to this group, topical antibiotics will be administered based on bio-gram and antibiogram results
15800531|NCT04446728|Behavioral|Training Webinar|The training webinar is a three hour training. The purpose of the study is to implement the Psychosocial Assessment Tool (PAT) in their center.
15800532|NCT04446728|Behavioral|Training Webinar Plus Implementation Enhanced Resources (TIER)|In addition the Training Webinar, sites randomized to Strategy II will identify a Champion and will participate in monthly consultation calls in support of implementation of the PAT
15800533|NCT04446715|Drug|sufentanil|Patients will receive sufentanil in spinal anesthesia
15800534|NCT04446715|Drug|meperidine|Patients will receive meperidine in spinal anesthesia
15800535|NCT04446715|Drug|Bupivacaine|Patients will receive 0.5% heavy bupivacaine in spinal anesthesia
15800536|NCT04446689|Behavioral|Biofeedback|This intervention will be measured by the Software Emwave Pro Plus during 4 weeks, which send out a sign captured by a non-invasive sensor such as an ear lobe fixed photoplethysmograph.
15800537|NCT04446676|Device|stabilization with stem|In both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization.
15800538|NCT04446676|Device|stabilization with sleeve|In both groups revision endoprosthesis of knee will be implanted with stem or sleeve stabilization.
15800539|NCT04446663|Drug|Toripalimab|Toripalimab 240mg ivdrip, every 3 weeks for 6 cycles, with 3 cycles combined with induction chemotherapy, 3 cycles combined with concurrent chemoradiotherapy
15800540|NCT04446663|Drug|Albumin-bound Paclitaxel|Albumin-bound Paclitaxel 260 mg/m2, d1 of every cycle, every 3 weeks for 3 cycles before radiotherapy
15800541|NCT04446663|Drug|Cisplatin|Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiotherapy Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiotherapy
15800542|NCT04446663|Radiation|intensity-modulated radiotherapy|Definitive IMRT of ≥66 Gy will be given .
15800543|NCT04446650|Drug|Fedratinib|Oral
15800544|NCT04446637|Drug|Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination (2 inhalations) via pMDI|Ipratropium/Levosalbutamol 20 mcg/50 mcg Aerosol Inhalation, Suspension 2 inhalations in the morning (single day)
15800545|NCT04446637|Drug|Salbutamol 100 mcg Inhaler (2 inhalations) + Ipratropium 20 mcg Inhalation Aerosol (2 inhalations) Free Combination via MDI|Salbutamol 100 mcg Inhaler, 2 inhalations + Ipratropium 20 mcg Inhalation Aerosol,2 inhalations in the morning (single day).
15800546|NCT04446624|Other|Music therapy intervention|Group psychotherapy with music intervention
15800547|NCT04446611|Diagnostic Test|First antenatal care + test-of-cure|Single point-in-time molecular point-of-care diagnostic screening and treatment for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis at first antenatal care visit and infection-specific test-of-cure 3 weeks post-treatment. Women with a positive test-of-cure will be re-treated. As CT/NG is a combined Xpert test, women who present with an incident infection (newly diagnosed infection) will be treated and managed accordingly.
15800548|NCT04446611|Diagnostic Test|First antenatal care + week 30-34 gestation (no test-of-cure)|Repeated molecular point-of-care diagnostic screening and treatment for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis at first antenatal care visit and at week 30-34 gestation. No test-of-cure will be conducted for women with positive test results; however, additional treatment will be provided to women with persistent/recurrent vaginal discharge.
15800549|NCT04446598|Device|non-ablative SMOOTH mode Erbium YAG laser|Erbium:YAG (Er:YAG) laser with non-ablative SMOOTH™ mode
15800550|NCT04446598|Drug|Tadalafil 5mg|oral tadalafil 5 mg was administered daily over a period of two months
15800551|NCT04446585|Device|Automated External Defibrillator (AED)|Deployment of AEDs
15800552|NCT04446585|Other|Training in cardiopulmonary resuscitation and AED use|Residents will undergo 30-minute courses at study start and if needed during the trial period. During the course they will also be recruited as citizen responders
15800553|NCT04446585|Other|Activation of citizen responders|Citizen responders will be activated in case of suspected cardiac arrest through the heart runner app.
15800554|NCT04446572|Biological|Lactobacillus salivarius CECT5713|Starting at day 0, women of the RA and INF groups consumed (oral route) a daily sachet with ~50 mg of freeze-dried probiotic (~9 log10 CFU of L. salivarius CECT5713) for 6 months or until a diagnosis of pregnancy (whatever happened first).
15800555|NCT04446559|Procedure|Sitting in chair position|For patients randomized in the chair group, we will perform the transfer to the chair immediately after the morning arterial blood gas. The chair position will be maintained for 3 hours, if the patient shows no clinical signs of discomfort or intolerance.
15800556|NCT04446546|Procedure|Vascular access by pass using a cold stored venous allograft|Creation or surgical repair of a vascular access for hemodialysis using a cold venous allograft
15800557|NCT04446533|Drug|Hydrogen Peroxide and Hyaluronic acid filming formulation|"Patients will undergo a professional oral hygiene session (causal therapy) and will be instructed to perform proper oral hygiene manoeuvres at home.
~After the causal therapy, the treatment of the pockets will be performed by probing, between 3 and 7 mm, with BMG0703 by means of a dedicated sterile syringe. The application will be repeated after approx. 5 minutes.
~One bottle of BMG0703 will then be given to the patients who will be instructed to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week.
~The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth)."
15800558|NCT04446533|Drug|Chlorhexidine 0.2%|"Patients will undergo a professional oral hygiene session (causal therapy) and will be instructed to perform proper oral hygiene manoeuvres at home.
~After the causal therapy, the treatment of the pockets will be performed by probing, between 3 and 7 mm, with Chlorhexidine 0.2% by means of a dedicated sterile syringe. The application will be repeated after approx. 5 minutes.
~One bottle of Chlorhexidine 0.2% will then be given to the patients who will be instructed to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week.
~The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth)."
15800559|NCT04446533|Drug|Placebo|"Patients will undergo a professional oral hygiene session (causal therapy) and will be instructed to perform proper oral hygiene manoeuvres at home.
~After the causal therapy, the treatment of the pockets will be performed by probing, between 3 and 7 mm, with a placebo product by means of a dedicated sterile syringe. The application will be repeated after approx. 5 minutes.
~One bottle of the placebo product will then be given to the patients who will be instructed to use it 3 times a day, after meals and after normal oral hygiene procedures, for at least one week.
~The subjects will then be re-evaluated after 3 days and after a week. During these check-ups, new samples will be collected at the level of the initial sampling sites and will be reassessed on the basis of the selected clinical indices (in particular plaque, bleeding and probing depth)."
15800560|NCT04446520|Procedure|autogenic drainage|breathing control using expiratory airflow to mobilize secretions from smaller to larger airways. Secretions are cleared independently by adjusting the depth and speed of respiration in a sequence of controlled breathing techniques during exhalation in addition to traditional physiotherapy (deep breathing exercise, diaphragmatic breathing and splinted coughing)
15800561|NCT04446507|Drug|Saroglitazar magnesium|1 dose of 2mg and 4 mg Saroglitazar magnesium will be given to subjects on Day 1
15800562|NCT04446494|Procedure|Identification and preservation of arm lymphatics (DEPART)|Indocyanine green was utilized to identify arm sentinel nodes, and 0.1 ml MB was injected into the arm sentinel nodes to reveal the subsequent-echelon nodes and lymphatics. Gross arm lymph nodes were examined by intraoperative partial frozen section and were removed if positive.
15800563|NCT04446481|Device|Neurofeedback|Neurofeedback will be tested in both groups of Vets
15800564|NCT04446468|Behavioral|PEACE|The intervention consists of three synergistic components that work to support the patient after inpatient psychiatric discharge: 1) Brief educational component, where the patient receives a one-hour, one-on-one, personalized educational session on suicide prevention; 2) Seven regular contacts after discharge, where the study psychologist who delivered the brief educational visit will contact the patient to monitor the patient's symptoms, assess treatment adherence, review their safety plan, and assist the patient with engaging in care, if needed; and 3) Mobile app, which aims to improve the patient's social connectedness and provide additional educational materials on suicide.
15800598|NCT04446195|Behavioral|Individualized Intervention|In this study, patients with the risk factors of insufficient intestinal preparation were treated with individualized intervention (mainly from the following aspects: chronic constipation, intestinal preparation not strictly in accordance with the requirements, body mass index > 25 kg / m2, age > 70 years old, with other diseases such as diabetes, Parkinson's disease, history of stroke or spinal cord injury, etc., application of tricyclic antidepressants or anesthetics).
15800565|NCT04446468|Other|Standard Psychiatric Hospital Discharge Care|Current VA standard discharge care includes five core elements. First, patients and their outpatient providers are required to be involved in discharge planning. Second, patients should be offered evidence-based treatments to address their mental health symptoms. Third, the inpatient team should work with the patient to complete a safety plan prior to discharge. Fourth, the inpatient team should arrange two follow-up care visits within 30 days of discharge. Fifth, the inpatient team in conjunction with the SPC assess whether patients are appropriate to be placed on the High Risk for Suicide List. Patients who are placed on the High Risk for Suicide List receive enhanced oversight as outlined in VA policy.
15800566|NCT04446455|Other|InVEST: Increased Velocity Exercise Specific to Task|Functional Power Training
15800567|NCT04446455|Other|TAPAT: Tonic and Phasic Alertness Training|Computerized cognitive training.
15800568|NCT04446442|Device|tDCS|A current of 1 mA will be administered for 20 minutes of with either anodal or cathodal tDCS administration to the right crus I/II area of the cerebellum.
15800569|NCT04446429|Drug|Proxalutamide|200 mg q.d.
15800570|NCT04446429|Other|Standard of Care|Standard of care as determined by the PI
15800571|NCT04446416|Device|NaviFUS System|Open the BBB using focused ultrasound and contrast agent SonoVue®
15800572|NCT04446416|Drug|Bevacizumab|An anti-angiogenic agent to block tumor growth
15800573|NCT04446403|Procedure|Suprascapular Nerve Block|The patient will be put in sitting down position with upper limbs pending beside the body then a high-frequency linear ultrasound probe will be positioned transversely above the spine of the scapula. The suprascapular nerve often appears as hypereccoic structure at the suprascapular notch. A 20-gauge spinal needle will be advanced in-plane from medial to lateral 10mL of bupivacaine 0.25% into the suprascapular notch deep to the superior transverse scapular ligament (STSL) and adjacent to the suprascapular artery (SSA) .
15800574|NCT04446403|Procedure|Axillary Nerve Block|Patient will be put in sitting position, with the shoulder in full adduction. linear transducer (8-14 MHz) will be positioned in the short axis orientation at the neck of humerous to identify the axillary artery about 1 to 3 cm from the skin surface.The artery is the most reliable landmark, then a 21-gauge 90 mm needle will be advanced in-plane and 10 mL of bupivacaine 0.25% will be injected adjacent to the artery.
15800575|NCT04446403|Procedure|posterior cord block|Patient will be put in supine position with head turned away from side that will be blocked with the arm abducted 90 and flexed at the elbow then linear transducer (8-14 MHz) will be positioned in short-axis just medial to coracoid process.Once the artery will be identified, an attempt will be made to identify the hyperechoic cords of the brachial plexus and their corresponding positions relative to the artery, although these may not always be identifiable. The needle will be inserted in plane from the cephalad end of the probe. 10 mL bupivacaine 0.25% will be injected at the posterior cord.
15800576|NCT04446403|Procedure|General anesthesia|General anaesthesia will be induced after giving nerve block in a standardized way with propofol 1.5-2.5mg/kg, fentanyl 2-3 µ/kg and atracurium 0.5mg/kg. maintenance of anaesthesia with isoflurane and atracurium 0.1mg/kg/20min.
15800577|NCT04446390|Other|Himalaya complete care toothpaste|Herbal toothpaste as a part of a caries preventive regimen
15800578|NCT04446390|Other|colgate cavity protection|fluoride toothpaste as a part of a caries preventive regimen
15800579|NCT04446377|Drug|Apilimod Dimesylate Capsule|LAM-002A is formulated in capsules containing 25 mg of apilimod dimesylate. The capsule is Swedish orange, Size 0.
15800580|NCT04446377|Other|Placebo|Microcrystalline cellulose in Swedish orange, Size 0 capsules
15800581|NCT04446364|Other|Ethanolic extract of Aloe vera gel cavity disinfectant|Application of Aloe vera gel after partial caries removal then taking dentin bacterial sample to be sure for reduction of bacterial count (streptococcus mutans and Lactobacillus) in deep cavity then add final restoration
15800582|NCT04446364|Other|Chlorohexadine|2%Chlorohexadine add on deep cavity as cavity disinfection after partial caries removal. Pre and post excavation bacterial count to measure bacterial reduction then add final restoration
15800583|NCT04446351|Drug|GSK6097608|GSK6097608 will be administered as an IV infusion.
15800584|NCT04446351|Drug|Dostarlimab|Dostarlimab will be administered as an IV infusion.
15800585|NCT04446338|Diagnostic Test|Antibody Test|Presence and Titer of Anti-Sars-CoV-2 Antbodies
15800586|NCT04446312|Drug|Bowel Prep|Orally ingested liquid bowel preparation
15800587|NCT04446299|Drug|Bowel Prep|Orally ingested liquid bowel preparation
15800588|NCT04446273|Device|Bi-Manu-Track|The PRI and DRI protocol provide robotic training for 45 minutes and impairment-oriented training for 45 minutes. The PRI group will start from the Bi-Manu-Track proximal mode (i.e., forearm) and then the Bi-Manu-Track distal mode (i.e., wrist). The DRI group will start from the Bi-Manu-Track distal mode (i.e., wrist) and then the Bi-Manu-Track proximal mode (i.e., forearm).In every session of robotic training, the patient will practice bilateral passive range of motion exercise, in which affected upper extremity is assisted by the unaffected side, and bilateral active range of motion exercise. Robotic training will be followed by impairment-oriented training.
15800589|NCT04446260|Drug|SHR-A1811|be administered via intravenous (IV) infusion
15800590|NCT04446247|Diagnostic Test|Owlet Smart Sock Sensor 3rd Generation|Pulse Oximetry
15800591|NCT04446234|Drug|Risperidone|Use medicine according to patients condition
15800592|NCT04446234|Drug|Aripiprazole|Use medicine according to patients condition
15800593|NCT04446234|Drug|Ziprasidone|Use medicine according to patients condition
15800594|NCT04446234|Drug|Amisulpride|Use medicine according to patients condition
15800595|NCT04446234|Drug|Quetiapine|Use medicine according to patients condition
15800596|NCT04446221|Other|phone survey|A questionnaire about the current symptoms and satisfaction for received treatment will be conducted over the phone for patients.
15800597|NCT04446208|Procedure|Endoscopy|Endoscopic treatment will consist in placement of a metal stent in a patient with early fistula (< 15 days) and/or a large fistula orifice, and no abscess, or double pigtail plastic stents if the fistula is older than 15 days and the orifice is small.
15800601|NCT04446169|Diagnostic Test|SARS-CoV 2 RNA PCR Urine|Search for SARS-CoV 2 RNA in urine through PCR
15800602|NCT04446169|Diagnostic Test|SARS-CoV 2 RNA PCR Semen|Search for SARS-CoV 2 RNA in Semen through PCR
15800603|NCT04446169|Diagnostic Test|Semen Qualitative Analysis|Search for Semen Alterations in patients with past SARS-CoV 2 infection
15800604|NCT04446169|Diagnostic Test|IIEF-5 questionnaire|IIEF-5 assessment in patients with past SARS-CoV 2 infection
15800605|NCT04446169|Diagnostic Test|Male Sexual Health Questionnaire (MSHQ)|Male Sexual Health Questionnaire (MSHQ) assessment in patients with past SARS-CoV 2 infection
15800606|NCT04446169|Diagnostic Test|IPSS questionnaire|IPSS assessment in patients with past SARS-CoV 2 infection
15800607|NCT04446169|Diagnostic Test|SECRET questionnaire|SECRET questionnaire assessment in patients with past SARS-CoV 2 infection
15800608|NCT04446169|Diagnostic Test|Interleukin assessment in semen|Assessment of Interleukin presence and quantitative analysis in semen, to study if a previous inflammation/infection due to SARS-CoV 2 in testis was present
15800609|NCT04446143|Behavioral|Mindfulness meditation|Mindfulness meditation
15800610|NCT04446130|Drug|Decitabine combined with HAAG Regimen|Decitabine :20mg/m2/d,d1~5, intravenous infusion; Homoharringtonine :1mg/d,d3~16,intravenous infusion; Aclarubicin :10mg/d, d3~d10, intravenous infusion; Cytarabine :10mg/m2,q12h,d3-16, subcutaneous injection; Granulocyte colony-stimulating factor (G-CSF): 50-300μg/d (when WBC counts are less than 20×10^9/L ),subcutaneous injection
15800611|NCT04446117|Drug|Cabozantinib|Supplied as 20-mg tablets; administered orally daily at 40mg
15800612|NCT04446117|Drug|Atezolizumab|Supplied as 1200 mg/20 mL vials; administered as an IV infusion once every 3 weeks (q3w)
15800613|NCT04446117|Drug|Abiraterone Acetate|Supplied as 500 mg tablets; administered orally daily at 1000mg with prednisone 5 mg orally bid
15800614|NCT04446117|Drug|Enzalutamide|Supplied as 40 mg capsules; administered orally daily at 160mg
15800615|NCT04446117|Drug|Prednisone|Supplied as 5 mg tablets; administered orally bid at 5 mg with abiraterone 1000mg orally daily
15800616|NCT04446104|Drug|Hydroxychloroquine Sulfate Tablets|Hydroxychloroquine tablet 400mg loading dose, followed by 200mg daily for 42 days
15800617|NCT04446104|Drug|Ivermectin 3mg Tab|Ivermectin tablet 12mg single dose
15800618|NCT04446104|Drug|Zinc|Zinc tablet 80 mg/vitamin C 500mg daily for 42 days
15800619|NCT04446104|Drug|Povidone-Iodine|Povidone-iodine throat spray (3 times daily) for 42 days
15800620|NCT04446104|Dietary Supplement|Vitamin C|Vitamin C tablet 500mg daily for 42 days
15800621|NCT04446091|Drug|Carilizumab + anti-angiogenic TKIs (available with fuquitinib, rigofenib, apatinib, etc.)|Observe the efficacy of immune checkpoint inhibitors combined with anti-angiogenic drugs for colorectal mucinous adenocarcinoma
15800622|NCT04446091|Drug|Carilizumab + anti-angiogenic TKIs (available with fuquitinib, rigofenib, apatinib, etc.)+Irinotecan|Observe the efficacy of immune checkpoint inhibitors combined with anti-angiogenic drugs and chemotherapy for colorectal mucinous adenocarcinoma
15800623|NCT04446078|Device|PEEK- acrylic resin prosthesis supported by 4 dental implants|Patients rehabilitated for edentulism of one or both arches through an implant supported fixed prosthesis
15800624|NCT04446065|Drug|Previfenon®|Every capsule of Previfenon® (patent pending) provides 250 mg EGCG ≥ 98% purity with a carefully selected set of excipients to improve flowability, stabilize EGCG against early auto-oxidation, and increase its hepatoprotective activity with prolonged use.
15800625|NCT04446065|Drug|Placebo|Participants will receive placebo starch capsules (250 mg plus excipients) identical in appearance and taste to Previfenon® capsules in a double-blind manner.
15800626|NCT04446052|Drug|GM-CSF priming|
15800627|NCT04446052|Drug|Placebo|Placebo
15800628|NCT04446039|Drug|Escitalopram|Treatment for depression
15800629|NCT04446039|Drug|Paroxetine|Treatment for depression
15800630|NCT04446039|Drug|Fluoxetine|Treatment for depression
15800631|NCT04446039|Drug|Mirtazapine|Treatment for depression
15800632|NCT04446039|Drug|Duloxetine|Treatment for depression
15800633|NCT04446039|Drug|Sertraline|Treatment for depression
15800634|NCT04446039|Drug|Venlafaxine|Treatment for depression
15800635|NCT04446039|Drug|Tianeptine|Treatment for depression
15800636|NCT04446039|Drug|Vortioxetine|Treatment for depression
15800637|NCT04446039|Drug|Desvenlafaxine|Treatment for depression
15800638|NCT04446039|Drug|Bupropion|Treatment for depression
15800639|NCT04446026|Drug|teneligliptin|teneligliptin 20mg PO qd for 24weeks
15800640|NCT04446026|Drug|Placebo|teneligliptin 20mg PO qd for 12weeks after placebo 1T PO qd for 12 weeks
15800641|NCT04446013|Other|Optic Nerve Sheath Diameter Measurement|The change in intracranial pressure via optic nerve sheath diameter measurement
15800642|NCT04446000|Biological|CSL730|solution for injection and infusion
15800643|NCT04446000|Drug|Placebo|A solution matching the excipient profile of CSL730 without the active substance
15800644|NCT04445987|Drug|ARQ-154|ARQ-154 foam 0.3% applied once daily for 52 weeks
15800645|NCT04445974|Behavioral|Expand your horizons: More than my skin|'Expand Your Horizon' is a self-help intervention which uses writing exercises to help individuals with poor body image practice focusing on their body-functionality rather than their physical appearance (Alleva et al., 2015). The materials for 'Expand Your Horizon' are freely available (Alleva et al., 2015), and permission has been granted to use and adapt the materials in this research. 'Expand Your Horizon' comprises of three 15 min writing exercises, typically completed over approximately six days. The intervention materials have been adapted for use with a population with skin diseases, and modified to use gender neutral language. Adaptions were made in consultation with experts by experience. The changes were reviewed and approved by the first author of the original intervention to ensure the materials were in keeping with the original intervention.
15800646|NCT04445974|Behavioral|Creative writing activities|In line with previous studies examining 'Expand Your Horizon' the active control condition will involve creative writing tasks (Alleva et al., 2015). Participants in the intervention condition will complete three 15 minute creative writing exercises, completed over six days.
15800647|NCT04445961|Diagnostic Test|Respiratory mechanics measurement|Measurement of peak inspiratory pressure, plateau pressure, calculation of static compliance and driving pressure
15800848|NCT04444271|Other|Placebo|100 ml of normal saline will be given intravenously to control arm
15800648|NCT04445961|Diagnostic Test|Gas exchange measurement|Measurement of arterial oxygen and tension and arterial dioxide tension, calculation of arterial partial oxygen tension to inspiratory oxygen fraction (PaO2/FiO2) ratio and alveolar dead space
15800649|NCT04445948|Drug|Esomeprazole 40 milligrams Oral Tablet|Proton Pump inhibitor
15800650|NCT04445948|Drug|Amoxicillin 1000 milligrams tablets|Penicillin derivative antibiotic
15800651|NCT04445948|Drug|Clarithromycin 500 milligrams Tablets|Macrolide antibiotic
15800652|NCT04445948|Drug|MetroNIDAZOLE 500 milligrams Oral Tablet|Antiprotozoal
15800653|NCT04445948|Drug|Lactoferrin Bovine sachets 200 milligrams|a protein found naturally in milk from humans and cows
15800654|NCT04445935|Drug|Bivalirudin Injection|The patients will receive iv Bivalirudin according to the institutional HIT protocol.
15800655|NCT04445935|Drug|Standard treatment|This group will receive standard anticoagulation with LMWH/UFH
15800656|NCT04445922|Drug|test-anastrozole tablet (Salutas Pharma GmbH)|Subjects were allocated to one of two groups randomly and equally with a 21-day washout interval between the two periods.All of them were randomized (1:1) to receive anastrozole as a single oral dose of the test drug or a single 1.0-mg oral dose of Arimidex
15800657|NCT04445922|Drug|reference-anastrozole tablet|Subjects were allocated to one of two groups randomly and equally with a 21-day washout interval between the two periods.All of them were randomized (1:1) to receive anastrozole as a single oral dose of the test drug or a single 1.0-mg oral dose of Arimidex
15800658|NCT04445909|Device|VA-ECMO|Deployment of extracorporeal membrane oxygenation cardiac assist device.
15800659|NCT04445896|Other|Qualitative Interview|Qualitative Interview to explore thoughts and feelings related to previous discussions around care at end of life
15800660|NCT04445883|Behavioral|Feeding Assistance|Patients will be receiving assistance during mealtimes. This includes assistance by opening packages, listing/explaining the food products on the tray, providing encouragement and companionship during mealtimes and directly feed patients.
15800661|NCT04445870|Other|data record|Data record on registers without medical files
15800662|NCT04445857|Drug|Calcitonin presented as Miacalcic® ampoules 100 IU/ml (1ml)|coadministration of calcitonin and a single-shot hyperbaric bupivacaine prolongs the length of the sensory block (min) of SA in tramadol-abuse patients independent of the route of calcitonin administration intrathecally or i.v.
15800663|NCT04445857|Other|normal saline (NS)|1ml NS intrathecally OR injection of 10 ml NS slowly IV over 5 min.
15800664|NCT04445844|Biological|Pelareorep|Given IV
15800665|NCT04445844|Other|Quality-of-Life Assessment|Ancillary studies
15800666|NCT04445844|Other|Questionnaire Administration|Ancillary studies
15800667|NCT04445844|Biological|Retifanlimab|Given IV
15800668|NCT04445831|Biological|ACI-35.030|Administration of a Low dose of ACI-35.030
15800669|NCT04445831|Biological|ACI-35.030|Administration of a Medium dose of ACI-35.030
15800670|NCT04445831|Biological|ACI-35.030|Administration of a High dose of ACI-35.030
15800671|NCT04445831|Other|Placebo|Administration of Placebo
15800672|NCT04445831|Biological|JACI-35.054|Administration of a Low dose of JACI-35.054
15800673|NCT04445831|Biological|JACI-35.054|Administration of a Medium dose of JACI-35.054
15800674|NCT04445818|Behavioral|More appreciation|
15800675|NCT04445818|Behavioral|Less criticism|
15800676|NCT04445818|Behavioral|More Fruit and Vegetable|
15800677|NCT04445805|Behavioral|Cognitive Behavioral Therapy for Insomnia (CBTI)|Consists of 6 prenatal 60-min sessions and 6 monthly postnatal sessions on sleep education, sleep restriction, stimulus control, cognitive therapy, and relaxation. Treatment will be delivered via telemedicine.
15800678|NCT04445805|Behavioral|Perinatal-enhanced Behavioral Therapy for Insomnia|Consists of 6 prenatal 60-min sessions and 6 monthly postnatal sessions on sleep education, sleep restriction, stimulus control, and metacognitive exercises. Treatment will be delivered via telemedicine.
15800679|NCT04445805|Behavioral|Attention Control|Will include education on sleep, circadian rhythms, and good sleep hygiene in addition to self-monitoring with sleep diaries.
15800680|NCT04445792|Other|Pharmacogenetic testing|Genetic testing of CYP2D6 and CYP2C19
15800681|NCT04445792|Other|Clinical decisions support|Prescribing recommendations to the provider based on the pharmacogenetic testing results
15800682|NCT04445779|Dietary Supplement|Coenzyme Q10|Patients will receive per-orally 10 mg/kg of body weight of coenzyme Q10 in form of Myokinon (PharmaNord, Denmark) in three divided doses. They will receive therapy for at least 10 days before surgical procedure.
15800683|NCT04445753|Other|Tai Chi exercise|Individuals in the intervention group will perform a 12-week Tai Chi exercise in company with a researcher.Following the warm-up movements (Qi-gong), the training protocol of the Tai Chi movements, which includes the 10-form Yang style, will continue for 12 weeks, with two sessions per week determined by the researchers.The first and second weeks of the exercise protocol will include introducing the Tai Chi philosophy and teaching 10 forms of Yang style to patients. For 12 weeks, individuals will practice 10 forms of Tai Chi exercises with a researcher in each session. Each session will be planned as one hour.
15800684|NCT04445753|Behavioral|Education (control group)|ndividuals in the control group will also be trained on heart failure, which will be applied to individuals in the intervention group. The only attempt to be made to the control group will be education.
15800685|NCT04445740|Behavioral|i♥rhythm project|behavioral mobile health intervention, targeting parents of 5-8 year olds, designed to promote consistent behavioral rhythms in children through consistent bedtimes, light exposure, meal timing, and physical activity.
15800686|NCT04445727|Combination Product|Vitamin C|Will apply 1000mg of vitamin C, TENS and manual therapy. One session will be held per week for 6 weeks.
15800687|NCT04445727|Combination Product|spinal manipulation|Applied spinal manipulations, tens and manual therapy.One session will be held per week for 6 weeks.
15800688|NCT04445727|Combination Product|Transcutaneous electrical nerve stimulation (TENS)|Received a manual therapy intervention and Tens. one session will be held per week for 6 weeks.
15800689|NCT04445714|Drug|dapagliflozin and saxagliptin|Combination of dapagliflozin and saxagliptin tablet once daily fixed dose combination of Dapa/Saxa 10 mg/5 mg administered orally
15800690|NCT04445701|Drug|AO-176|Humanized monoclonal antibody (mAb) targeting CD47
15800691|NCT04445701|Drug|AO-176 + Dex|Humanized mAb targeting CD47 plus dexamethasone
15800692|NCT04445701|Drug|AO-176 + Dex + Bort|Humanized mAb targeting CD47 plus dexamethasone plus bortezomib
15800693|NCT04445688|Drug|AD036|Oral administration before bed
15800694|NCT04445688|Drug|Atomoxetine|Oral administration before bed
15800695|NCT04445688|Drug|Placebo|Oral administration before bed
15800696|NCT04445675|Other|Support for breastfeeding and the feeding of infants' with breast milk|The content of the support for breastfeeding and the feeding of infants' with breast milk consists of the titles of the importance of breastfeeding and breast milk, the effect of breast milk on preventing jaundice, the importance of early start of breastfeeding, breastfeeding techniques and positions in infants, milking, storage and later use of milk, increasing the quantity and quality of milk, and nutrition of the mother during breastfeeding.
15800697|NCT04445662|Behavioral|Financial incentives|Escalating financial rewards for saliva cotinine levels <30 ng/mL, assessed 14 times over 24 weeks
15800698|NCT04445662|Drug|Varenicline|"Day 1 - 3: 0.5 mg daily
~Day 4 - 7: 0.5 mg twice daily
~Day 8 - Week 12: 1 mg twice daily
~Dose/schedule may be adjusted based on medical history and clinician judgement"
15800699|NCT04445662|Behavioral|Tobacco coaching|5 one-on-one tobacco cessation coaching sessions over 24 weeks
15800700|NCT04445649|Diagnostic Test|Coma-Recovery-Scale-Revised (CRS-R)|CRS-R assessments (15 minutes) are repeated weekly after study entry
15800701|NCT04445636|Drug|Dexmedetomidine|Caudal block with Dexametomedine as an adjuvant to bupivacaine.
15800702|NCT04445636|Drug|Morphine|Addition of morphine as adjuvant to bupivacaine during caudal block.
15800703|NCT04445623|Drug|Prasugrel Hydrochloride 10 MG Oral Tablet|administration of prasugrel daily for 15 days
15800704|NCT04445623|Drug|Placebo|administration of placebo daily for 15 days
15800705|NCT04445597|Other|Sampling of tissue|In all groups of participants, tissue from the nasal cavity and olfactory system will be surgically removed
15800706|NCT04445584|Diagnostic Test|7 Tesla MRI|7 Tesla MRI
15800707|NCT04445571|Procedure|Thin catheter technique or standard ET-tube for surfactant administration|Surfactant administration by intubation with regular ET-tube followed by immediate extubation to CPAP (INSURE) or by thin catheter during spontaneous breathing and continued CPAP.
15800708|NCT04445558|Dietary Supplement|oral nutritional supplementation|Adjunction of oral nutritional supplementation
15800709|NCT04445558|Dietary Supplement|intradialytic parenteral nutrition|Adjunction of intradialytic parenteral nutrition
15800710|NCT04445545|Device|High intensity laser therapy (HILT)|High intensity laser therapy at 25 J / cm2 and 50 J / cm2 in continuous and pulsed modalities at powers of 1 and 5 watts applied to 4 experimental groups.
15800711|NCT04445545|Device|Stretching exercises|Passive static stretching exercises for the shortened upper trapezius muscle. The exercises will consist of five sets of 30 second stretches.
15800712|NCT04445532|Other|Gene expression analysis|Gene expression analysis
15800713|NCT04445532|Other|Genomic analysis|Genomic analysis
15800714|NCT04445532|Other|Protein expression analysis|Protein expression analysis
15800715|NCT04445532|Other|Proteomic profiling|Proteomic profiling
15800716|NCT04445532|Other|Polymerase chain reaction|Polymerase chain reaction
15800717|NCT04445532|Other|Mass spectrometry|Mass spectrometry
15800718|NCT04445532|Other|Immunohistochemistry|Immunohistochemistry
15800719|NCT04445532|Other|Metabolomics profiling|Metabolomics profiling
15800720|NCT04445532|Other|Methylation and epigenetic analysis|Methylation and epigenetic analysis
15800721|NCT04445532|Other|Liquid biopsy analysis|Liquid biopsy analysis, such as cell-free DNA or circulating tumor cell analysis
15800722|NCT04445532|Other|Laboratory biomarker analysis|Laboratory biomarker analysis (such as AFP, CA19-9, CEA)
15800723|NCT04445519|Drug|NCX 470 0.065%|NCX 470 Ophthalmic Solution, 0.065%
15800724|NCT04445519|Drug|NCX 470 0.1%|NCX 470 Ophthalmic Solution, 0.1%
15800725|NCT04445519|Drug|Latanoprost 0.005%|Latanoprost Ophthalmic Solution, 0.005%
15800726|NCT04445506|Drug|Dexamethasone|4mg dexamethasone was given to some patients three times daily for 2 days, 2 times daily for 2 days, once daily for 2 days.
15800727|NCT04445493|Device|MindRhythm Harmony|Passive recording of the head pulse
15800728|NCT04445480|Procedure|Popliteal block|Sciatic nerve block at popliteal fossa would perform before the participant undergoing angioplasty in experimental arm.
15800729|NCT04445480|Other|Control|Sciatic nerve at popliteal fossa would be scanned with the ultrasound. The toothpick would be applied to simulate the procedure of nerve block.
15800730|NCT04445467|Drug|Favipiravir|Favipiravir
15800731|NCT04445454|Biological|Mesenchymal stromal cells|Bone marrow collection and MSC expansion cultures will be carried out at the Laboratory of Cell and Gene Therapy (LTCG) at the University of Liège as described in IMPD and its SOPs.
15800732|NCT04445428|Biological|oral polio vaccine + information|Bivalent OPV (GSK), 0.1 ml administered orally on a sugar lump
15800733|NCT04445428|Behavioral|Information|Advice regarding how to protect oneself from COVID-19
15800734|NCT04445415|Diagnostic Test|COVID-19 antibodies testing|antibodies aganist COVID-19 detected in the serum of patients
15800735|NCT04445389|Drug|GX-19|DNA vaccine expressing SARS-CoV-2 S-protein antigen
15800736|NCT04445389|Drug|Saline|Saline
15800737|NCT04445376|Other|Physical Exercises|Aerobic Training and Breathing Exercises.
15800738|NCT04445363|Drug|Jacatinib hydrochloride cream|Jacatinib hydrochloride cream/placebo applied topically in the morning and in the evening, administered continuously for 24 weeks
15800739|NCT04445363|Drug|Placebo|Dose extension: Placebo
15800740|NCT04445350|Other|External Focus Of Attention|Instructions and feedback are used to direct the learner's focus to an external source (e.g. the effect the intended movement has) promoting long-term learning by stimulating automatic cognitive control processes.
15800741|NCT04445350|Other|Internal Focus Of Attention|In contrast, adopting an internal focus of attention (e.g. focus on specific body areal) can disrupt automatic control processes and interfere automatic movement.
15800742|NCT04445337|Procedure|Stellate Ganglion Block|An injection of local anesthetic into the front of the neck. Medication used for the block include- clonidine 100 mcg, Decadron PF 5mg, and 0.25% bupivacaine 5 ml is delivered.
15800843|NCT04444284|Biological|Investigational RSV vaccine MV-012-968 (Dosage 1)|Single dose administered intranasally on Day 1
15800743|NCT04445324|Behavioral|Transitional Online Peer Support Group (n=20)|Trained Peer Support Workers (PSWs) from the Quebec Association of PSWs will organize and facilitate two series (one per condition) of 10 co-learning recovery workshops in a manner to simulate a typical peer support group. The difference of these transitional peer support groups to real community-based peer support groups is that (A) they will be facilitated by trained PSW, (B) they will have a personal-civic recovery focus, and (C) they will have a fixed, predetermined duration (10 weekly 60 to 90-minute online workshops). Typical Peer support groups bring together people who have similar concerns so they can explore solutions to overcome shared challenges and feel supported by others with similar experiences and who may better understand each other's situation. Peer support groups should ideally be independent from mental health and social services, although some services may facilitate and encourage the creation of (transitional) peer support groups, as is the case here. (WHO)
15800744|NCT04445324|Other|Control Group (pharmacotherapy and/or psychotherapy, n=10)|When individuals show up at the Emergency Department (T1) of the Montreal Mental Health University Institute, they are evaluated by the Evaluation and Liaison Module during their hospital stay when they are hospitalized. A diagnostic is established or confirmed by psychiatrists on the ward, and coded according to the World Health Organisation International Classification of Disease (ICD-10). According to these diagnoses, after discharge (T2) they are referred to a specialized outpatient clinic for an appointment (T3). Whether for (a) psychotic disorders or for (b) anxiety and mood disorders, pharmacotherapy or psychotherapy, or a combination of both, are then offered in accordance with guidelines of the Royal College of Physicians and Surgeons of Canada.
15800745|NCT04445311|Drug|Ivermectin|3 successive days ttt of ivermectin started within 48 hours of symptoms
15800746|NCT04445298|Diagnostic Test|Transepidermal water loss|We will assess the skin with transepidermal water loss (TEWL) by using a condenser-chamber system placed lightly on the skin. This will be performed at baseline, then after every 4 skin tape strips.
15800747|NCT04445298|Diagnostic Test|Skin tape stripping|Adhesive skin sampling discs will be pressed against the skin in a hairless location followed by lifting it free of the skin. The discs will be evaluated for lipid content, protein, and filaggrin byproducts in the collected skin sample.
15800748|NCT04445298|Diagnostic Test|Blood draw|We will draw blood to look at the vitamin D, total immunoglobulin E (IgE), and the filaggrin gene which is important in maintaining the skin barrier.
15800749|NCT04445298|Diagnostic Test|Bacterial PCR swab|Skin swab from the superficial skin will be collected to be assessed in the laboratory via PCR for the presence of staphylococcus aureus.
15800750|NCT04445285|Drug|Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase)|2.5mg Pulmozyme/ Recombinant human deoxyribonuclease (rh-DNase) aerosolized treatment once every 24 hours for five (5) consecutive days; a total of five (5) doses
15800751|NCT04445285|Drug|0.9%sodium chloride|Placebo of 0.9% sodium chloride every 24 hours for five (5) consecutive days; a total of 5 doses
15800752|NCT04445272|Drug|Tocilizumab|Treatment with Tocilizumab
15800753|NCT04445246|Drug|Inhaled ILOPROST|Inhaled Iloprost 20 mcg every 8 hours for 5 days only delivered by nebulization.
15800754|NCT04445220|Biological|SBI-101|SBI-101 is a biologic/device combination product that combines two components: allogeneic human mesenchymal stromal cells (MSCs) and an FDA-approved plasmapheresis device. SBI-101 is administered via integration into a Continuous Renal Replacement Therapy circuit and is designed to regulate inflammation and promote repair of injured tissue.
15800755|NCT04445207|Biological|Convalescent Plasma|One to two 200 mL units of Convalescent plasma per infusion, up to 6 total units within a 3-week period.
15800756|NCT04445194|Biological|Recombinant new coronavirus vaccine (CHO cell) low-dose group|Intramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
15800757|NCT04445194|Biological|Recombinant new coronavirus vaccine (CHO cells) high-dose group|Intramuscular injection of deltoid muscle of upper armof 50μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
15800758|NCT04445194|Biological|Recombinant new coronavirus vaccine (CHO cells) placebo group|Intramuscular injection of deltoid muscle of upper armof 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
15800759|NCT04445181|Drug|The physician's prescription in routine clinical practice|This is an Observational study that will not involve prescription of the drugs.
15800760|NCT04445168|Behavioral|Telephone-based motivational interviews|2-year telephone-based motivational interviews to increase physical activity.
15800761|NCT04445155|Behavioral|Modified DECIDE Parent and Provider Intervention|It will include three 60 minutes sessions. Session 1 (Decisions and Agency) is designed to increase awareness of their role in clinical interactions and encourage participation and decision making in care. Session 2 (the Who, How, and Why of Decisions) teach skills for understanding treatment decisions in terms of roles, processes, and reasons involved. Session 3 (Self-efficacy and Consolidation) encourages parents to ask questions about their adolescents' behavioral health and health care and treatment options. The provider component is designed to improve provider communication in three key areas: 1) perspective taking to understand circumstances and perceptions; 2) attributional errors or attributing negative parent behaviors to character traits; and 3) receptivity to parent participation and collaboration.
15800762|NCT04445142|Procedure|fovea-sparing internal limiting membrane peeling|fovea-sparing internal limiting membrane peeling surgery
15800763|NCT04445129|Device|Portable EEG Device|Portable EEG device is lightweight and designed for nighttime wear.
15800764|NCT04445129|Device|Portable ECG Device|Portable ECG device is waterproof and will be adhered to the chest of the participant.
15800765|NCT04445129|Device|Accelerometry|Portable accelerometry device is noninvasive and will capture data on participant activity level, including intensity of movement, rest, and sleep.
15800766|NCT04445116|Other|Endeavor™|Endeavor™ is a digital, non-drug investigational treatment that is delivered through an action video game and is designed to target cognitive deficits in adolescence and young adults with pediatric onset MS. Endeavor™ is an investigational product, meaning that it is currently being tested and is not yet cleared by the U.S. Food and Drug Administration (FDA).
15800767|NCT04445103|Diagnostic Test|Assessment of cardiac function|Echocardiographic examination and assessment of cardiac biomakers
15800768|NCT04445090|Drug|BI 1569912|BI 1569912
15800769|NCT04445090|Drug|Placebo|Placebo
15800844|NCT04444284|Biological|Investigational RSV vaccine MV-012-968 (Dosage 2)|Single dose administered intranasally on Day 1
15800770|NCT04445077|Other|Dementia Competence Education for care home setting|The intervention is a competency-based education program for care home staff who provide dementia care in Mainland China.
15800771|NCT04445077|Other|Printed educational materials|The educational materials will be delivered to the participants in the control group for their self-study.
15800772|NCT04445064|Biological|IO102|100µg each week during the 3 weeks prior to surgery (total of 3 to 4 doses maximum)
15800773|NCT04445051|Device|New intermittent catheters variation 1 and 2 for both male and females|The new catheters are not named at this point but are intended for intermittent drainage of the bladder.
15800774|NCT04445038|Drug|610|Recombinant anti-IL-5 Humanized Monoclonal Antibody
15800775|NCT04445038|Drug|Placebo|Placebo
15800776|NCT04445025|Drug|Elagolix 200 MG|Elagolix 200mg twice daily orally for 60 days prior to beginning frozen embryo transfer preparation
15800777|NCT04445025|Drug|Leuprolide Acetate 3.75 MG/ML|Leuprolide Acetate intramuscularly every 28 days (twice) prior to beginning frozen embryo transfer preparation
15800778|NCT04445025|Diagnostic Test|Lab work|Serum follicle stimulating hormone (FSH), estradiol, luteinizing hormone (LH), progesterone, human chorionic gonadotropin (hCG), serum for microarray analysis, complete blood count, and chemistry panel with liver functions levels will be drawn via blood draw
15800779|NCT04444999|Procedure|Carbon Dioxide Angiography|• Automated carbon dioxide angiography: Patients are placed in the Trendelenburg position with the feet elevated of 10 º degrees. Carbon Dioxide automatic injection will be performed by digital Angiodroid injection system
15800780|NCT04444986|Drug|FAVIR 200 MG FT|FAVICOVIR containing 200 mg favipiravir manufactured by Kocak, Turkey.
15800781|NCT04444986|Drug|AVIGAN 200 mg FT|AVIGAN containing 200 mg favipiravir manufactured by Toyama, Japan
15800782|NCT04444973|Procedure|Balloon pulmonary angioplasty|Balloon dilatation of sub segmental pulmonary artery web disease
15800783|NCT04444960|Procedure|percutaneous coronary intervention|Intracoronary physiology and imaging-guided intervention strategy versus angiography-guided intervention strategy for complex high-risk coronary heart disease patients
15800784|NCT04444934|Other|histological examination|Patients were classified in two groups based on the surgeon's visual examination of the right diaphragmatic peritoneum. The accuracy of visual examination has been assessed comparing surgeon's opinions to histological examination
15800788|NCT04444895|Drug|Lanadelumab|Rollover participants will receive 300 mg of lanadelumab solution in a PFS SC injection once Q2W or Q4W for 26 consecutive weeks.
15800789|NCT04444869|Drug|Cisplatin injection|Standard dose cisplatin given concurrently with radiation therapy
15800790|NCT04444856|Drug|Eptacog alfa (activated)|The women included in the study population have been treated with NovoSeven® (eptacog alfa (activated)) according to local routine clinical practice at the discretion of the treating physician.
15800791|NCT04444856|Other|Standard of care|The women included in the study population have been treated according to local routine clinical practice at the discretion of the treating physician.
15800792|NCT04444843|Drug|Mycophenolate Mofetil Capsules|Patients who received MMF+TAC+ Corticosteroids immunosuppressive regimen as first choice post transplantation
15800793|NCT04444830|Drug|Sprix|Intranasal Ketorolac - used as directed for an appropriate, previously established indication
15800794|NCT04444817|Drug|Tacrolimus|Similar to the clinical routine, as soon as a patient is able to swallow and has a sufficient gastrointestinal activity, Tacrolimus-based immunosuppression using Prograf®, Advagraf® or Envarsus® will be started. Furthermore, calcineurin inhibitors-based immunosuppression will be used (initial dose based on the patients' body weight) with the goal of tough levels of 3-7 ng/mL in the first seven days after liver transplantion, depending on immune status and indication for transplantation. Further tough levels will be determined based on factors such as patients' history and indication for liver transplant.
15800795|NCT04444804|Drug|Rivaroxaban (Xarelto, BAY 59-7939)|Dosage at the discretion of the treating physician
15800796|NCT04444804|Drug|LMWH and Phenprocoumon|Dosage at the discretion of the treating physician
15800797|NCT04444778|Device|CPAP|Continuous positive airway pressure
15800798|NCT04444765|Other|Collection of clinical and biological data during renal replacement therapy sessions|Collection of clinical and biological data during renal replacement therapy sessions. Two additional blood samples collected during and after RRT session (critically ill patients all have arterial catheter thus additional samples will not need additional puncture).
15800799|NCT04444752|Drug|CBP-201|CBP-201 subcutaneous(SC) injection.
15800800|NCT04444752|Drug|placebo|subcutaneous(SC) injection
15800801|NCT04444739|Other|radiographic data collection|From existing radiological Images (upright standing X-ray and supine MRI of the lumbar spine), specific radiographic parameters will be extracted
15800802|NCT04444726|Device|Ultra Violet A Device.+ Topical medical treatment|"Hands of the patient are irradiated in the UVA device after soaking for 20 minutes into 10 litres of water containing psoralen meladenine capsule."
15800803|NCT04444726|Device|Iontophoresis device + Topical medical treatment|Tap-water iontophoresis was given 3 times weekly for 10 min. The direct current level was slowly increased, guided by the occurrence of tingling sensations. The maximum level was 30 mA.
15800804|NCT04444726|Drug|"Topical medical treatment (Betamethasone dipropionate 0.05%  diprolene  )"|thin film of the cream is being applied to the affected areas for 2 times per day.
15800845|NCT04444284|Other|Placebo|Single dose administered intranasally on Day 1
15800846|NCT04444284|Biological|Investigational RSV vaccine MV-012-968 (Dosage 3)|Single dose administered intranasally on Day 1
15800847|NCT04444271|Drug|Mesenchymal stem cells|1. Frozen MSCs will be resuspended in 100ml normal saline for immediate use and given intravenously. The patients should be pre-medicated to avoid allergic reactions to third party MSCs. Each patient in Experimental arm will be given 2 x 106 cells/kg will be administered on day 1,7 in addition to supportive care
15800806|NCT04444687|Diagnostic Test|Test for SARS-CoV-2|"As part of normal emergency evaluation due to symptoms or following standard operation procedure for patients heading to the operating theatre the status for SARS-CoV-2 is evaluated (gene expert, Roche)
~After intubation samples are acquired in the OR
~tracheal aspirate specimen directly after intubation (as part of standard operation procedures for CoVID-19 patients)
~blood sample (as part of standard operation procedures for CoVID-19 patients)
~fluid sample and smears from abdominal cavity as soon as this is accessed either by laparoscopy or laparotomy
~Sample from laparoscopic smoke filters (Laparoshield™ Laparoscopic Smoke Filtration System)
~Fluid samples and smears are frozen at -80 degrees celcius for conservation in the OR."
15800807|NCT04444674|Biological|ChAdOx1 nCoV-19|Dose of 5-7.5x10^10vp of ChAdOx1 nCoV-19
15800808|NCT04444674|Biological|Normal saline 0.9%|Normal saline 0.9% as placebo
15800809|NCT04444648|Combination Product|No intervention|No intervention
15800810|NCT04444635|Procedure|Serratus Anterior Plan Block+ Fentanyl infusion|"After induction of anesthesia, the patients will be put on the lateral position with the diseased side up. A linear ultrasound transducer will be placed in a sagittal plane over the mid-clavicular region of the thoracic cage.
~Then counting down ribs till the fifth rib will be identified in the mid-axillary line. The following muscles will be identified overlying the fifth rib: the latissimus dorsi (superficial and posterior),teres major (superior) and serratus muscles (deep and inferior). Under complete sterile conditions, the needle (25 G needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus anterior muscle. Then, 2 mg/kg of 0.25% bupivacaine will be injected with continuous ultrasound guidance. In addition to continuous fentanyl infusion"
15800811|NCT04444635|Drug|Fentanyl|Continuous fentanyl infusion throughout the surgical procedure.
15800812|NCT04444622|Biological|AlloStim|Living bioengineered, non-genetically manipulated, activated Th1-like immune cells differentiated and expanded from precursor cells purified from blood of healthy unrelated donors
15800813|NCT04444609|Other|Blood tests sputum, nasal lavage and brushing|Venesection, sputum nasal lavage and brushing if appropriate
15800814|NCT04444596|Diagnostic Test|Conjunctival swab and nasopharyngeal swab|Both conjunctival swab and nasopharyngeal swab for SARS-COV 2 are conducted in patients with COVID-19.
15800815|NCT04444570|Device|Continuous glycemia measuring device (Dexcom) implantation into the subcutaneous tissue|14 days before the date of the surgery and after the surgery patient will have implemented the device for continuous glycemia measurement (Dexcom). During standard control visit 14 days after the surgery for skin sutures removal the device will be taken out and data of whole period of time will be collected
15800816|NCT04444557|Other|Beck Depression Inventory (BDI)|The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression
15800817|NCT04444544|Other|High Risk Abdominal Surgery|Pancreatectomy, Esophagectomy, Gastrectomy and Hepatectomy
15800818|NCT04444518|Behavioral|VAX-MOM Intervention|The multi-component VAX-MOM intervention will be comprised of: training in communication, provider prompts or standing orders, and feedback on vaccination rates.
15800819|NCT04444518|Behavioral|Standard of Care|Standard vaccine education and processes provided to patients by obstetric practices.
15800820|NCT04444505|Other|Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health|Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health
15800821|NCT04444492|Drug|Ranibizumab Injection|initial three injections of Ranibizumab - afterwards pro re nata monthly
15800822|NCT04444492|Device|Laser photocoagulation|Areas of capillary non-perfusion will be treated with photocoagulation upto 4 times
15800823|NCT04444479|Other|ECG verification|The correct positioning of the PICC catheter tip will be verified using ECG.
15800824|NCT04444479|Other|X-ray verification|The correct positioning of the PICC catheter tip will be verified using X-ray imaging.
15800825|NCT04444466|Drug|UCB8600|Study participants will receive UCB8600 in a pre-specified sequence during the Treatment Period.
15800826|NCT04444466|Other|Placebo|Study participants will receive Placebo in a pre-specified sequence during the Treatment Period matching UCB8600.
15800827|NCT04444453|Device|Wearable Pedometer|Pedometer worn on wrist
15800828|NCT04444440|Drug|Ciprofloxacin|Fluoroquinolone antibiotic.
15800829|NCT04444440|Other|Placebo Pill|Placebo Pill
15800830|NCT04444427|Drug|GLR2007|Administered orally, once daily for 21 days followed by a 7-day treatment holiday.
15800831|NCT04444414|Other|Manual therapy|bilateral manipulation lumbosacral, hip joint gapping, stretching the hip rotators with hip and knee flexion, femorotibial gapping, decompression of connective tissue of the patellofemoral region, internal and external joint line opening in laterality, mobilization of the base of the fibula, tibiofibular-talus gapping, and muscle strengthening.
15800832|NCT04444414|Other|Control group|The control group received no treatment, they only attended the evaluations.
15800833|NCT04444388|Dietary Supplement|cocoa|Sachets of 5 grams of cocoa daily supplementation
15800834|NCT04444388|Dietary Supplement|Placebo|Sachets of 5 grams of maltodextrin daily supplementation
15800835|NCT04444375|Diagnostic Test|balance test|balance test
15800836|NCT04444362|Device|Inspiratory Muscle Training|IMT underwent 5 days of 30 breaths twice daily at 50% (+5% increase each week) of maximum inspiratory pressure (MIP)
15800837|NCT04444349|Drug|Coenzyme Q10|Coenzyme Q10 is a cardiovascular health supplement. It is a component of the electron transport chain and participates in aerobic cellular respiration, which generates energy in the form of ATP. The ingredients in Coenzyme Q10 help regulate the body's production of free radicals, strengthen the arteries and heart, and reverse oxidation.
15800838|NCT04444349|Dietary Supplement|Placebo|placebo that looks and tastes identical to Coenzyme Q10
15800839|NCT04444336|Behavioral|Cross-sectional study examining the impact of information sources to obtain information about COVID-19 on depression and anxiety symptoms|Cross-sectional study examining the impact of information sources to obtain information about COVID-19 on depression and anxiety symptoms
15800840|NCT04444323|Other|3D Telemedicine|The intervention is a consultation conducted using a 3D form of telemedicine
15800841|NCT04444297|Other|3D Telemedicine|A consultation performed with a 3D form of telemedicine
15800842|NCT04444297|Other|2D Telemedicine|A consultation performed with 2D (standard) telemedicine
15800849|NCT04444258|Other|Application of computer aided virtual reality glasses|Experimental I Group: After the Fetal Development Assessment Information Form (FEGBF), a computer-aided and guided virtual reality application prepared by the researchers including the phases of the fetus week by week will be watched and then FEGBF will be applied again by changing the locations of the questions.
15800850|NCT04444258|Other|Teaching fetal development theoretically|Control Group: FEGBF will be applied after 4 hours of theory training. Virtual pregnancy application will not be watched.
15800851|NCT04444245|Procedure|lipoaspiration harvest tSVF|Use of disposable, sterile microcannula lipoharvest to acquire tSVF
15800852|NCT04444245|Procedure|Platelet Rich Plasma|Standard venipuncture, concentration of PRP in FDA approved device (Emcyte II)
15800853|NCT04444245|Procedure|Endovaginal Ultrasound|Endovaginal Ultrasound guidance to intra-ovarian placement, bilaterally
15800854|NCT04444245|Device|Cellular Isolation cSVF|Digestion of tSVF with Liberase, isolation & concentration of cSVF in Centricyte 1000
15800855|NCT04444245|Drug|Normal Saline (NS) .9% 10 mL Injection|10 cc Sterile Normal Saline for Injection
15800856|NCT04444245|Device|emulsification tSVF|Harvested tSVF emulsification with sterile, disposable Nanofat screen device
15800857|NCT04444232|Other|Media Intervention|View an educational video
15800858|NCT04444232|Other|Survey Administration|Complete survey
15800859|NCT04444219|Other|Breakfast meals|Fifteen volunteers will undergo a medical and dietary assessment and their health status will be evaluated through a complete blood count. Then, they will come after overnight fasting and will consume one of two breakfast meals, including 114g bread, 40g cheese and 15g dry mushrooms (meal 1) or 114g bread, 40g cheese and 200g tomatoes (meal 2). Blood samples will be obtained on timepoints 0h, 30min, 1h, 1,5h, 2h, 2,5h and 3h after breakfast intake. Two weeks later, the same volunteers will consume the other breakfast meal.
15800860|NCT04444206|Procedure|Transvaginal ultrasound cervical length screening|Cervical lenght and Consistence Cervical Index measurements performed, between 11 and 13 weeks + 6 days, in the , between 19 and 22 weeks and i between 29 and 32 weeks during the ultrasound examinations required by the monitoring routine of pregnancy.
15800861|NCT04444193|Drug|Durvalumab|Anti-PD-L1 Monoclonal Antibody
15800862|NCT04444193|Drug|Lenvatinib Oral Product|Lenvatinib (Lenvima, Eisai China) is a novel angiogenesis inhibitor which targets vascular endothelial growth factor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptor β, RET and KIT
15800863|NCT04444180|Diagnostic Test|Virtual hand illusion (VHI)|Using VHI, the two basic self-representation of sense of ownership and sense of agency of the subjects will be observed.
15800864|NCT04444167|Biological|AK104|Subjects will receive AK104 and lenvatinib until disease progression or for a maximum of 24 months
15800865|NCT04444167|Drug|Lenvatinib|Subjects will receive AK104 and lenvatinib until disease progression for a maximum of 24 months
15800866|NCT04444154|Behavioral|Control group|oral hygiene advice given orally in the chair during the bonding appointment and at each check-up appointment.
15800867|NCT04444154|Behavioral|Group with active participation|oral hygiene advice given orally in the chair during the bonding appointment and at each check-up appointment with a demonstration of brushing methods in the sink with active participation (use of plate developer and then the Oral B electric toothbrush with special orthodontic head) during the bonding appointment as well than at each check-up appointment.
15800868|NCT04444154|Behavioral|Group with video and quizz|oral hygiene advice given orally in the chair during the bonding appointment and at each check-up appointment with have an additional appointment between the device bonding appointment and the first check-up. This is a 15-minute session dedicated to teaching oral hygiene. This session will include watching of an educational video followed by a quiz, as well as the application of the methods taught in the sink (using plate developer and the Oral B electric toothbrush with special orthodontic head).
15800869|NCT04444141|Biological|AK104|The subjects will receive AK104 till disease progression or for a maximum of 24 months.
15800870|NCT04444128|Diagnostic Test|CMR with T1 and T2 mapping|Subjects undergo CMR study with contrast agent (gadobutrol 0.1 mmol/kg): T1 and T2 mapping, volumes, function, strain and LGE is performed.
15800871|NCT04444102|Procedure|Yoga-based stretching|"Different yoga postures (ASANA) were isolated from conventional yoga practice to stretch different muscle groups.
~Muscle groups stretched: hip extensor and adductors, hip & plantar flexors, shoulder extensors, shoulder horizontal adductors, shoulder extensors-adductor, wrist flexor, trunk extensors, lateral flexors, and trunk rotators."
15800872|NCT04444089|Diagnostic Test|lung ultrasound|Lung ultrasound with a curvilinear probe (DDED) is performed in all patients in a supine position on the lateral wall of the chest at approximately the level of the lower ribs using an ultrasound probe at a frequency of 4-12 MHz (AcusonX300, Siemens Korea, Seoul, South Korea). The mean number of B-lines detected on the ultrasound image and the percentage of patients who showed B-lines on their images were recorded. The mean of three measurements is used. Inter-observer variability is estimated to be 0.766 (95% confidence interval 0.675-0.847).
15800873|NCT04444076|Device|REGENETEN Bioinductive Implant|REGENETEN bioinductive Implant,a reconstituted bovine origin type I collagen mesh with a proprietary high porosity system that is commercialized sterile, dehydrated and desiccated in two sizes (20x26mm and 25x31mm). It will be implanted following supraspinatus tendon repair.
15800874|NCT04444063|Procedure|Non-Incised Papilla Surgical Approach|"Horizontal or oblique incision is done on the buccal mucosa as far as possible from the marginal keratinized tissue and the inter dental papilla The horizontal/oblique incision is extended mesio-distally enough to allow proper visualization of the defect A full thickness flap is elevated apico- coronally to expose the coronal limit of the defect Scaling and root planning are done using mini-curettes and power driven ultrasonic tips with care trying to maintain fibers attached to the cementum Granulation tissue is removed with mini-curettes detached from the bony walls and removed from the base of the papilla carefully with microblades and microscissors .
~1ry soft tissue closure will be performed by horizontal mattress suture 2mm from the edges of the incision as a first line of closure and then simple interrupted suture as a second line of closure using (5-0, 6-0) polypropylene suture."
15800875|NCT04444050|Drug|BMS-986331|Specified dose on specified days
15800876|NCT04444050|Other|Placebo, Matching BMS-986331|Specified dose on specified days
15800877|NCT04444037|Device|OCT-guided PCI|using optical coherence tomography imaging to help PCI procedure
15800878|NCT04444011|Drug|Anaprazole Sodium|Anaprazole Sodium isthePPI inhibitor
15800882|NCT04443998|Device|Bone reducion forceps|Repositioning forceps provide a more accurate anatomical reduction and higher pre-compression can be achieved compared to IMF or manual reduction
15800883|NCT04443972|Other|PD VitalOs cement®|PD VitalOs cement®* is a synthetic bone grafting cement designed for bone void filling and bone regeneration in dental surgery
15800884|NCT04443972|Other|Hydroxyapatite bone graft|a bioceramic bone substitute, providing a scaffold for bone deposition
15800885|NCT04443972|Other|biodegardable collagen membrane|provide efficacious barriers that were interposed between the flap and root surface.
15800886|NCT04443959|Behavioral|Mindfulness-based therapy for Insomnia|Treatment consists of 6 weekly digital sessions during pregnancy via the online program 'A Mindful Way to Healthy Sleep.'
15800887|NCT04443946|Drug|Propofol|5 mg kg-1 h-1 propofol was pumped continuously after endotracheal intubation.
15800888|NCT04443946|Drug|1% Sevoflurane|add 1% end-tidal sevoflurane 20 minutes after endotracheal intubation.
15800889|NCT04443946|Drug|1% Sevoflurane continue|1% sevoflurane continued to maintain anesthesia after endotracheal intubation.
15800890|NCT04443946|Drug|Sufentanil|0.01 μ g kg-1 min-1 sufentanil were pumped continuously at maintain phase
15800891|NCT04443946|Drug|2% Sevoflurane|2% sevoflurane continued to maintain anesthesia after endotracheal intubation.
15800892|NCT04443946|Drug|Propofol half|2.5 mg kg-1 h-1 propofol was pumped continuously after endotracheal intubation.
15800893|NCT04443920|Drug|Tranexamic acid (TXA)|Randomly assigned [1:1 ratio] using a computer generated table of random numbers to 1 of the 2 intervention groups
15800894|NCT04443920|Drug|Placebo Normal Saline (NS)|Randomly assigned [1:1 ratio] using a computer generated table of random numbers to 1 of the 2 intervention groups
15800895|NCT04443907|Biological|OTQ923|Single intravenous infusion of OTQ923 cell suspension
15800896|NCT04443907|Biological|HIX763|Single intravenous infusion of HIX763 cell suspension.
15800897|NCT04443907|Biological|OTQ923 or HIX763|Single intravenous infusion of either OTQ923 or HIX763, based on review of data from Part A and/or Part B by Health agencies after a formal interim analysis
15800898|NCT04443894|Other|PECS block|PECS block is performed at the side of surgery (II) before incision with ropivacaine 0,375%.(30 ml). General anesthesia is induced and maintained with midazolam, fentanyl, propofol and rocuronium. Pain is assessed postoperatively according to protocol (24 hours and after 3 months).
15800899|NCT04443894|Other|local infiltration|local infiltration of the surgical wound before incision with πwith ropivacaine 0,375%.(30 ml). General anesthesia is induced and maintained with midazolam, fentanyl, propofol and rocuronium. Pain is assessed postoperatively according to protocol (24 hours and after 3 months).
15800900|NCT04443881|Drug|Anakinra 149 MG/ML Prefilled Syringe [Kineret]|Anakinra (100 mg/ 6 hours) i.v infusión during 15 days
15800901|NCT04443868|Drug|Nitric Oxide-Releasing Drug|Nasal Spray + Nasal Irrigation
15800902|NCT04443855|Behavioral|Water quality|"Hardware: Free supplies chlorine tablets (Aquatabs; NaDCC) and a safe storage vessel to treat and store drinking water.
~Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the treatment of all drinking water for children < 36 months of age."
15800903|NCT04443855|Behavioral|Sanitation|Hardware: Free child potties, sani-scoop hoes to remove feces from household environments, latrine upgrades to a dual pit latrine Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the use of latrines for defecation and the removal of human and animal feces from the compound.
15800904|NCT04443855|Behavioral|Hand washing|"Hardware: Hand washing stations, soapy water bottles located at hand washing locations, detergent soap to supply soapy water bottles.
~Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on hand washing with soap at critical times around food preparation, defecation, and contact with feces."
15800905|NCT04443855|Behavioral|Water quality, Sanitation, Hand washing (Combined WASH)|"Hardware: Free supplies Aquatabs; (NaDCC) and a safe storage vessel to treat and store drinking water. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the treatment of drinking water for children < 36 months.
~Hardware: Free child potties, sani-scoop hoes to remove feces from household environments, latrine upgrades to a dual pit latrine. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the use of latrines for defecation and the removal of human and animal feces from the compound.
~Hardware: Hand washing stations, soapy water bottles, detergent soap to supply soapy water bottles. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on hand washing with soap at critical times as food preparation, defecation, and contact with feces."
15800906|NCT04443855|Behavioral|Nutrition|"Supplement: Lipid-based Nutrient Supplement (LNS) delivered daily from ages 6 to 24 months.
~Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages modeled on those recommended in the Guiding Principles for Complementary Feeding of the Breastfed Child and the recent UNICEF Program Guide for Infant and Young Child Feeding Practices.General messages will include (1) practice exclusive breastfeeding from birth to 6 months of age and introduce complementary foods at 6 months of age while continuing to breastfeed; (2) continue breast feeding as you did before receiving LNS; (3) provide your child micronutrient-rich foods such as meat, fish, eggs, and vitamin A rich fruits and vegetables; and (4) feed your child at least 2-3 times per day when 6-8 months old and 3-4 times per day when 9-24 months old."
15800907|NCT04443855|Behavioral|Nutrition, Water quality, Sanitation, Hand washing|Each of the interventions described above for Water Quality, Sanitation & Hand washing (Combined WASH) Plus the intervention described above for nutrition.
15800908|NCT04443842|Behavioral|Financial and social incentives|"Participants will be credited with HK$1000 in their virtual accounts at the beginning of the trial. After baseline step counts are gathered in the second week, participants will lose HK$40 for each subsequent week that they do not meet their personal weekly step target.
~The social incentives are peer comparison and social support. Participants receive feedback of their physical activity performance by assessing whether they met or exceeded their step count target, followed by positive messages for encouragement. Nominated supporters will be informed of participants' performance for social support."
15800909|NCT04443829|Biological|CD19CAR T-cells|Infusion with: CD19CAR T-cells
15800910|NCT04443790|Drug|Leptin Human|
15800911|NCT04443777|Other|Resistance Training|Both groups will perform the resistance training protocol that will consist of a warm-up on the bench press and leg press, both with workload at 50% of 1-RM. After a 2-minute rest, the resistance training session will be started. It will consist of 4 sets of bench press and leg press exercises at 65% of 1-RM with maximum repetitions until concentric failure, with the execution speed of 2x2. The bench press exercises will be followed by the leg press exercises with no interval between them. A 2-minute interval will allowed after each series of exercises.
15800912|NCT04443751|Drug|SHR-1702|SHR-1702 monotherapy, administered IV
15800913|NCT04443738|Other|phone survey|A questionnaire about the current symptoms and satisfaction for recieved treatment will be conducted over the phone for patients.
15800914|NCT04443725|Drug|Hydroxychloroquine , Sofosbuvir, daclatasvir|Hydroxychloroquine (hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 14 days (dose reductions for weight < 45 kg or GFR (glomerular filtration rate) <50ml/min) alone; as provided by the MOHP protocol), Sofosbuvir 400 mg once daily for 14 days and daclatasvir 90 mg for 14 days.
15800915|NCT04443725|Drug|Standard of care treatment|Hydroxychloroquine (hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 14 days (dose reductions for weight < 45 kg or GFR (glomerular filtration rate) <50ml/min) alone; as provided by the MOHP protocol),
15800916|NCT04443699|Behavioral|Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health|Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health
15800917|NCT04443686|Drug|Low dose radiation and ALA|Patients will be seen in the CRU and administered ALA on day 1, 8, and 15. Open-field radiotherapy and targeted-field radiotherapy will be given on days 1, 8, and 15
15800918|NCT04443673|Dietary Supplement|Glycine|Along with habitual treatment for their severe condition, participants will receive 0.5 g/kg/day glycine by nasogastric tube, divided in four equal doses in a day, since their enrollment and until they are weaned from mechanical ventilator or die.
15800919|NCT04443660|Other|Blood test|Blood samples taken to test levels of autophagy and apoptosis
15800920|NCT04443647|Drug|Oxytocin|Syntocinon nasal spray
15800921|NCT04443647|Drug|Placebo|Placebo nasal spray
15800922|NCT04443634|Procedure|Ultrasound Guided Adductor Canal Block|It will be performed at the midthigh level, approximately halfway between the superior anterior iliac spine and the patella, a high-frequency linear ultrasound (US) transducer 5-12 MHz probe. Underneath the sartorius muscle the femoral artery was identified, with the vein just inferior and the saphenous nerve just lateral to the artery. From the lateral side of the transducer a 10-cm, 18-gauge Tuohy needle (Braun Medical, Melsungen, Germany) was inserted in plane, through the Sartorius muscle. With the tip of the Tuohy needle placed just underneath the vasto-adductor membrane and lateral to the artery and the saphenous nerve, 20 ml local anesthetic mixture will be injected to expand the adductor canal. the volume of local anesthetic will be selected according to the studied group
15800923|NCT04443634|Procedure|Ultrasound Guided Saphenous Nerve Block|"It will be performed at the intermuscular plane between the sartorius and the vasus medialis muscles at the lower third of the thigh.
~The US probe will be positioned on the front of the lower part of the thigh immediately above the patella to see both the patella (hyperechoic curved line) and vastus medialis infront of it (closer to skin). The probe is then moved medially over the vastus medialis till we see the end of the muscle and we see an intermuscular plane between it and Sartorius muscle. A 20 guage spinal needle will be then passed in an in plane direction within the substance of vastus medialis muscle and then pass within the vastus medialis until it faces the intermuscular plane between VM muscle and Sartorius. Once the needle tip is located in close proximity to the target structures, gentle aspiration will be performed followed by 20 ml local anesthetic will be injected."
15800924|NCT04443634|Procedure|General anesthesia|"General anesthesia was induced by propofol 1-2 mg/kg fentanyle 100micg and laryngeal mask was inserted. Maintanace of anesthesia was performed by sevoflurane 2-3%.
~Then the surgical procedure started. All patients had arthroscopic knee surgery( ACL repair) surgery under tourniquet control.
~Immediately after end the surgical procedure, either ACB or combined ACB and saphenous nerve block distal to adductor canal were performed according to randomization."
15800925|NCT04443634|Drug|Bupivacaine 20 ml|20ml bupivacaine 0.5%
15800926|NCT04443634|Drug|Bupivacaine 30ml|30ml bupivacaine 0.5%
15800927|NCT04443634|Drug|Bupivacaine 10ml|10ml bupivacaine 0.5%
15800928|NCT04443621|Behavioral|questionnaire|Questionnaire battery for assessment of dignity, cognition, self-sufficiency, and depression.
15800929|NCT04443621|Behavioral|in-depth interview|Individual in-depth interviews with OAwD on the topic of dignity (two interviews with each respondent at a 12-month interval) .
15800930|NCT04443608|Drug|Patiromer Powder for Oral Suspension [Veltassa]|Powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink
15800931|NCT04443608|Drug|Placebo|Powder will be mixed with a liquid (water, apple or cranberry juice) and given to patient to drink
15800932|NCT04443595|Procedure|Dual-scopic pancreatic necrosectomy（DPN）|Treatment of Acute Severe Pancreatitis with DPN
15800933|NCT04443569|Drug|Lidocaine patch|Lidocaine patch to be placed in post-operative recovery area and used in addition to routine post-cesarean delivery pain management
15800934|NCT04443556|Drug|Tramadol|Before the closure of the thoracotomy, the surgeon will place two catheters through a Tuohy needle into fascial planes for continue the RISS block. First catheter tip will be placed towards the interfascial planes between the rhomboid major and intercostal muscles and the second catheter tip will be placed in subserratus fascial plane. Continue local anesthetics will be injected through the catheters for 48 hours. Also an IV patient-controlled analgesia device containing tramadol will be provided. Tramadol consumptions and postoperative numeric rating scale (NRS) scores for pain will be recorded.
15800935|NCT04443556|Other|IV PCA|An IV patient-controlled analgesia device containing tramadol will be provided. Tramadol consumptions and postoperative numeric rating scale (NRS) scores for pain will be recorded.
15800936|NCT04443543|Drug|Capecitabine (Xeloda) Pharmacogenetic Test Reagents|CRT: 625mg/m2 bid Monday-Friday per week XELIRI: 1000mg/m2 bid d1-14
15800937|NCT04443543|Drug|irinotecan|CRT:80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7) XELIRI: 200mg/m2 bid d1 FOLFIRINOX: 150mg/m2 d1
15800938|NCT04443543|Radiation|IMRT|Pelvic Radiation: 50Gy/25Fx
15800939|NCT04443543|Drug|Oxaliplatin|FOLFIRINOX: 85mg/m2 d1
15800940|NCT04443543|Drug|5Fluorouracil|FOLFIRINOX: 400mg/m2 iv d1bolus, 2400mg/m2 ivgtt 46h
15800941|NCT04443543|Drug|Tislelizumab|200mg iv
15800942|NCT04443530|Drug|Ultimaster™ Tansei™ stents|Patients receiving Ultimaster™ Tansei™ stents
15800943|NCT04443517|Procedure|Alpha Optimization|Intraoperative oscillatory EEG alpha optimization involves real-time acquisition of oscillatory alpha power from the frontal EEG with individualized titration of desflurane and opioid.
15800944|NCT04443517|Behavioral|Emergence from anesthesia with propofol|Infusion of 400 mg/h of propofol during the final 10-20 minutes of surgery. Total doses of propofol administered are likely to be in the range of 1-3 mg/kg.
15800945|NCT04443504|Behavioral|The Connected Family Series|The intervention is an online, self-paced post-adoption family intervention that occurs over a 4-week period to support adoptive families post-adoption.
15800946|NCT04443478|Procedure|Radical gastrectomy with dissection of lower mediastinal lymph node|Radical gastrectomy for gastric cancer should be consistent with Japanese gastric cancer treatment guideline. In particular, lymphadenectomy should include at least No.110, No.111 and part of No. 112(112pul and 112aoA)
15800947|NCT04443452|Diagnostic Test|Quantitative Sensory Testing|"PPT: An electronic data collection unit will be used featuring an electronic algometer connected with a laptop where the amount of pressure will be displayed on the screen. When the pressure pain detection threshold is reached (the point where the pressure sensation starts to be experienced as pain), the individual will press a button at a handheld device, that will automatically store the pressure value in the system and serve as an indication, for the examiner, to stop the testing.
~TS: A pinprick stimulator (Weight: 256mNewton) will be used. The examiner will apply the pen that features a retractable blunt needle in a repetitive manner (once per second for ten seconds). The individual will be asked for the intensity of pain (NRS) at the first and at the last time and the given score will be noted.
~CPM: A manual blood pressure sphygmomanometer will be used in conjunction with the electronic algometer described above (PPT)."
15800948|NCT04443452|Radiation|Radiographic Evaluation|Tibiofemoral and patellofemoral radiographs of the most painful knee will be taken using a standardised protocol (standing posterior-anterior (PA) and skyline views) and will be scored by a single experienced observer in order to generate data for correlation analyses with the primary and secondary outcomes. A Perspex Rosenberg template with lead beads is used for the standing PA view to standardising the degree of knee flexion, foot rotation and magnification. PA radiographs are taken with the participant facing the x-ray tube while standing on the Rosenberg jig and leaning forwards with their thighs touching the anterior aspect of the jig, the x-ray beams passing from the posterior aspect through to the anterior aspect of the knee. Variable jigs are used for the skyline view to obtaining 300 of knee flexion with the participant lying in a reclined supine position on a couch. Grading of radiographs for changes of OA will be based on the Kellgren and Lawrence (K/L) score.
15800949|NCT04443452|Procedure|Ultrasound-guided Aspiration|Ultrasound scanning will be conducted on the most painful knee to identify synovial effusion. During the ultrasound scan, the supra-patellar pouch, medial and lateral recess of the knees will be assessed for synovial thickening, synovial fluid/effusion and for positive power Doppler. An ultrasonic probe will be used to direct ultrasonic waves onto the knee joint during sonography, and a computer converts the signals received so that they can be presented on the screen. During skin application, a sterile probe cover and sterile acoustic gel will be used. Once the best aspiration location is identified and the location of the needle insertion marked, the skin will be prepared with a cleansing agent such as iodine or chlorhexidine. The needle may be introduced into the skin either parallel to the probe or perpendicular to the probe. Once the aspiration is completed, the needle will be removed, the skin cleansed, and a bandage will be applied.
15800950|NCT04443452|Diagnostic Test|Muscle Strength Assessment|Isometric testing will be done at 30 and 60 degrees of flexion as done in the previous study and the participant will be in sitting position with hips and knees strapped to keep the position standardised.
15800951|NCT04443452|Diagnostic Test|Function Assessment (A)|"The participant will start in a seated position. The participant will stand up upon therapist's command, walk 3 meters, turn around, walk back to the chair and sit down. The time will stop when the participant is seated. The subject can use an assistive device. If the assistive device is used, it will be documented.
~Important Note: A practice trial will be completed before the timed trial."
15800952|NCT04443452|Diagnostic Test|Function Assessment (B)|The 30-Second Chair Test is administered using a chair. The participant is seated in the middle of the chair with arms crossed at the wrists and held against the chest. The participant will practice a repetition or 2 before completing the test. If a participant must use their arms to complete the test, they are scored 0. The participant is encouraged to complete as many full stands as possible within 30 seconds. The participant is instructed to fully sit between each stand. While monitoring the participant's performance to ensure proper form, the tester silently counts the completion of each correct stand. The score is the total number of stands within 30 seconds (more than halfway up at the end of 30 seconds counts as a full stand). Incorrectly executed stands are not counted. The 30-second chair stand involves recording the number of stands a person can complete in 30 seconds rather than the amount of time it takes to complete a pre-determined number of repetitions.
15800953|NCT04443452|Diagnostic Test|Balance Assessment|Static balance and postural sway either in the medial-lateral or antero-posterior direction will be assessed using the RS Scan force plate. The participant will be asked to stand on the plate looking straight forward for 30 seconds in two conditions: first with their eyes open and then with eyes closed. Medial-lateral, antero-posterior and total sway will be recorded.
15800954|NCT04443439|Device|GE Discovery MR750 3.0t superconducting MRI|T2WI, FLAIR, DWI, 3D BRAVO, 3D-ASL, rs-fMRI, DKI sequences to exclude other organic lesions
15800955|NCT04443426|Dietary Supplement|Oral 3-hydroxybutyrate salts|Comercially available 3-hydroxybutyrate salts with 36 grams of 3-OHB salts three times daily.
15800956|NCT04443426|Dietary Supplement|Carbohydrate Placebo|Comercially available carbohydrate sports drink. The placebo dose is isocaloric to the 3-hydroxy butyrate dose.
15800957|NCT04443426|Dietary Supplement|Ketone Monoester|Commercially available ketone monoester in a dosage isocaloric to 3-OHB salts.
15800958|NCT04443413|Radiation|Proton Beam Radiation Therapy|Undergo proton beam radiation therapy
15800959|NCT04443413|Other|Questionnaire Administration|Ancillary studies
15800960|NCT04443413|Radiation|X-ray Therapy|Undergo x-ray therapy
15801058|NCT04442633|Drug|Miconazole Oral gel|Miconazole oral gel: applied three to four times daily for three weeks
15800961|NCT04443387|Drug|Vitamin D|A double-blinded, randomized, placebo-controlled study of VitD supplementation on 45 asthmatics with VitD deficiency was performed. Moderate to severe asthmatics between 18 and 65 years of age who had clinician-diagnosed asthma with 25-hydroxyvitamin D3 (25 D3) level less than 20ng/mL at the screening visit were recruited at the Rashid Hospital, Dubai, U.A.E., and the Zayed Military Hospital, Abu Dhabi, U.A.E. Subjects were excluded if they had used any previous VitD supplementation, had any other respiratory diseases or co-morbid conditions or were smokers. According to the American Academy of Family Physicians guidelines, participants received 50, 000 IU of VitD orally or placebo weekly over 8 weeks. Subjects were blinded to treatment and allocated to receive a VitD dose or placebo by the randomization schedule.
15800962|NCT04443387|Other|Placebo|A double-blinded, randomized, placebo-controlled study of VitD supplementation on 45 asthmatics with VitD deficiency was performed. Moderate to severe asthmatics between 18 and 65 years of age who had clinician-diagnosed asthma with 25-hydroxyvitamin D3 (25 D3) level less than 20ng/mL at the screening visit were recruited at the Rashid Hospital, Dubai, U.A.E., and the Zayed Military Hospital, Abu Dhabi, U.A.E. Subjects were excluded if they had used any previous VitD supplementation, had any other respiratory diseases or co-morbid conditions or were smokers. According to the American Academy of Family Physicians guidelines, participants received 50, 000 IU of VitD orally or placebo weekly over 8 weeks. Subjects were blinded to treatment and allocated to receive a VitD dose or placebo by the randomization schedule.
15800963|NCT04443348|Radiation|Radiation Therapy Boost|Participants randomized to the low-dose or high-dose RT boost group will be receiving treatment on Day 1-3 of Cycle 1 of pembrolizumab. Proton therapy may be used in the high dose RT group.
15800964|NCT04443348|Drug|Pembrolizumab|"Neoadjuvant Phase: Day 1 (once every 6 weeks) of Cycles 1-4 (by intravenous infusion) over about 30 minutes.
~Adjuvant Phase: Pembrolizumab may be given post-surgery for up to 4 cycles (once every 6 weeks) by intravenous infusion over about 30 minutes. Pembrolizumab after surgery is optional and should be discussed with the study doctor."
15800965|NCT04443348|Drug|Paclitaxel|Starting Week 3 and administered once per week for 12 weeks (up to 12 doses) by intravenous infusion over about 30 minutes.
15800966|NCT04443348|Drug|Carboplatin|"Carboplatin is optional for TNBC patients and should be discussed with the study doctor.
~Starting Week 3 and administered once per week for 12 weeks (up to 12 doses) by intravenous infusion over about 30 minutes."
15800967|NCT04443348|Drug|Cyclophosphamide|Starting Week 15 and administered every 2 weeks for 4 cycles (up to 4 doses) into your vein (by intravenous infusion).
15800968|NCT04443348|Drug|Doxorubicin|Starting Week 15 and administered every 2 weeks for 4 cycles (up to 4 doses) into your vein (by intravenous infusion). Doxorubicin will be administered after pembrolizumab.
15800969|NCT04443348|Drug|Capecitabine|"Capecitabine after surgery is optional for TNBC patients and should be discussed with the study doctor.
~Starting 3-6 weeks after surgery, administered orally twice daily for 6 courses, each 3 weeks long (for a total of 18 weeks)."
15800970|NCT04443335|Behavioral|continous feeding|At the beginning, all the patients received continuous feeding. After achieving ≥80% of the nutrition target calories (25-30 kcal/kg/d) through continuous feeding, the patients were randomly assigned into the sequential feeding (SF) group or the continuous feeding (CF) group with a random number table. Patients in the CF group received continuous feeding with constant velocity by enteral feeding pump over one day.
15800971|NCT04443335|Behavioral|sequential feeding|At the beginning, all the patients received continuous feeding. After achieving ≥80% of the nutrition target calories (25-30 kcal/kg/d) through continuous feeding, the patients were randomly assigned into the sequential feeding (SF) group or the continuous feeding (CF) group with a random number table. In the SF group, continuous feeding was changed into time-restricted feeding. The total daily dosage of enteral nutrition was equally distributed during three time periods at 7-9:00, 11-13:00 and 17-19:00. Other times of the day were fasting times. Enteral nutritional suspension in each time period was administered at a uniform rate within two hours by an enteral feeding pump.
15800972|NCT04443322|Drug|Durvalumab Injection|Anti-PD-L1 Monoclonal Antibody
15800973|NCT04443322|Drug|Lenvatinib 4 MG|Lenvatinib (Lenvima, Eisai China) is a novel angiogenesis inhibitor which targets vascular endothelial growth factor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptor β etc.
15800974|NCT04443309|Drug|Camrelizumab|Camrelizumab 200mg,iv,d1,q2w
15800975|NCT04443309|Drug|Lenvatinib|Lenvatinib 8mg (<60kg) or 12mg (≥60kg),po,d2,qd
15800976|NCT04443296|Drug|CCRT+TIL|Cisplatin based chemotherapy concurrently with radiotherapy, then TIL infusing following concurrent chemoradiotherapy
15800977|NCT04443283|Other|No intervention|This is a observation study, with no intervention
15800978|NCT04443270|Drug|Chloroquine phosphate|"Drug: Chloroquine phosphate
~Dosage form, frequency and duration: 300 mg per day during initial 30 days and 150 mg per day during the next 30 days."
15800979|NCT04443257|Other|assessment of the sequelae after hospitalization for Sars-COV-2|the incidence of chronic respiratory failure and fibrosis, as well as of comorbidities including cardiovascular, metabolic, renal, hepatic, neurological, and psychological diseases
15800980|NCT04443244|Drug|Botulinum Toxin Type A Injection (Botulax®) 24Units|Experimental: Botulax® 24Units
15800981|NCT04443244|Drug|Botulinum Toxin Type A Injection (Botulax®) 48Units|Experimental: Botulax® 48Units
15800982|NCT04443244|Drug|Botulinum Toxin Type A Injection (Botulax®) 72Units|Experimental: Botulax® 72Units
15800983|NCT04443244|Drug|Botulinum Toxin Type A Injection (Botulax®) 96Units|Experimental: Botulax® 96Units
15800984|NCT04443244|Other|Normal Saline|Placebo Comparator: Normal Saline
15800985|NCT04443231|Device|Optical Coherence Tomography Angiography|AngioVue (Optovue, Fremont, CA, USA) was used to capture the OCTA images before ICL surgery and at 3 months follow-up.
15800986|NCT04443218|Device|Edwards PASCAL Transcatheter Valve Repair System|The Edwards PASCAL Valve Repair System is indicated for the percutaneous reconstruction of an insufficient mitral valve.
15800987|NCT04443205|Other|Data record|Data record
15800988|NCT04443192|Drug|ZF874|ZF874 is a novel chemical chaperone that is specifically designed to rescue the folding of the Z variant of alpha-1-antitrypsin (A1AT). It is being developed for the treatment of alpha-1-antitrypsin deficiency (AATD) caused by the Z-mutation.
15800989|NCT04443192|Drug|Placebo|Placebo to ZF874
15800990|NCT04443166|Combination Product|A platelet-rich plasma (PRP)+ hyaluronic acid (HA) program|a combination of intra-articular knee injection with platelet-rich plasma (PRP) and hyaluronic acid (HA)
15800991|NCT04443153|Device|Personalized Feedback|Provides tailored information to the user about what glycemic risk they may be facing as well as how glycemic control and system use looked in the past week. Treatment decision and therapy changes are entirely left to the decision of the user.
15800992|NCT04443153|Device|Decision Support System|CGM-based system that includes Personalized Feedback (PF) and further assists with treatment recommendations for common metabolic challenges
15800993|NCT04443153|Device|Sensor-Augmented Pump therapy|A mode in Diabetes Assistant (DiAs) that combines Diabetes Assistant, Insulin pump, CGM, ketone meters, and glycemic treatment guidelines together to manage diabetes.
15800994|NCT04443140|Diagnostic Test|PCR, lung ultrasound|PCR for Covid-19
15800995|NCT04443127|Device|Virtual Reality Training Session|VR based motor priming intervention will be given for 16 sessions, comprising of 45 minutes, 4 times/week for the duration of 4 weeks on two VR environments.
15800996|NCT04443127|Behavioral|Motor-Relearning Program|Motor-Relearning Program intervention will be given for 16 sessions, comprising of 45 minutes, 4 times/week for the duration of 4 weeks on two VR environments.
15800997|NCT04443114|Other|Organ Donation Workshop|Discussion Moderated by Peer Educators Didactic Session 1: Biomedical Aspects of Living Donation Didactic Session 2: Organ Donation and Transplantation in the US- Statistics and Procedures Moderated Debate: Living Organ Donation: Halal or Haram? Facilitated Group Discussions with Peer Educators
15800998|NCT04443114|Other|End of Life Care Workshop|Discussion Moderated by Peer Educators Didactic Session 1: Critical Theological Concepts about Sickness and Health in Islamic Bioethics Didactic Session 2: Islamic Rulings about Brain Death, and Withdrawing/Withholding Life Support Moderated Panel Discussion: End-of-life Decision Making Facilitated Group Discussions with Peer Educators
15800999|NCT04443101|Other|different types of intracular lens|different types of intracular lens
15801000|NCT04443088|Drug|INV-1120|INV-1120 is an investigational selective and potent small molecule indicated for the treatment of solid malignancies including, but not limited to colorectal, breast, pancreatic, lung and liver cancers.
15801001|NCT04443075|Device|faecal sample collector|The frontline medical workers mainly exposed under the stress of fighting against 2019-nCoV
15801003|NCT04443049|Drug|Lenvatinib|Lenvatinib will be given once a day(OD) orally at dose of 8 mg if body weight is < 60 kg and 12 mg if body weight is > 60 kg
15801004|NCT04443049|Drug|Mebendazole|mebendazole will be given at dose of 100 mg orally twice a day (BD) daily
15801005|NCT04443049|Other|Placebo|Placebo (Tab Mecovit) orally twice a day (BD) daily
15801006|NCT04443036|Drug|Albumin-Bound Paclitaxel|"125mg/m2 IV d1、8，Q3W
~until disease progression, lost follow-up visit, death , unacceptable toxicity"
15801007|NCT04443036|Drug|Toripalimab|"240 mg，IV d1，Q3W
~until disease progression, lost follow-up visit, death , unacceptable toxicity, Maximum treatment duration is 24 months"
15801008|NCT04443023|Device|chosen TAVI valve|chosen TAVI valve
15801009|NCT04443010|Drug|Onfekafusp alfa|"This is an open label phase 1/2/2b study in subjects with newly diagnosed glioblastoma.
~The study will be conducted in three consecutive parts: First the dose finding part to determine the RD of L19TNF in combination with chemoradiotherapy, followed by a signal seeking part that investigates first signs of activity and then an activity evaluation part that studies the efficacy of L19TNF in combination with chemoradiotherapy against chemoradiotherapy alone."
15801010|NCT04443010|Drug|Temozolomide|Patients will receive radiotherapy and TMZ. Treatment start with chemoradiotherapy is foreseen after surgical resection or biopsy of glioblastoma
15801011|NCT04442984|Drug|Irinotecan|d1 Irinotecan 180mg/m² every two weeks
15801012|NCT04442984|Drug|Oxaliplatin|d1 Oxaliplatin 85 mg/m² every two weeks
15801013|NCT04442984|Drug|5-FU|d1-2 5-FU 2200 mg/m² every two weeks
15801014|NCT04442984|Drug|5-FU|d1 5-FU 250 mg/m² every two weeks
15801015|NCT04442984|Drug|Leucovorin|d1 Leucovorin 400 mg every two weeks
15801016|NCT04442984|Drug|5-FU|d1 5-FU 400 mg/m² every two weeks
15801017|NCT04442984|Drug|5-FU|d1-2 5-FU 2400 mg/m² every two weeks
15801018|NCT04442971|Behavioral|Music Stimulation|Patients wear headphones for 30 minutes/day over a period of four weeks and listen to their preferred music.
15801019|NCT04442971|Behavioral|Alternative Stimulation|Patients wear headphones for 30 minutes/day over a period of four weeks and listen to an audio book.
15801020|NCT04442971|Behavioral|No Auditory Stimulation|Patients wear headphones for 30 minutes/day over a period of four weeks and hear silence.
15801021|NCT04442958|Other|Convalescent Immune Plasma|One dose of 200 mL of convalescent ımmune plasma derived from recently recovered donors with the neutralizing antibody titers above 1:640 was transfused to the patients as an addition to standart critical care treatment.
15801022|NCT04442945|Drug|ANAVEX3-71|Active oral dose of ANAVEX3-71
15801023|NCT04442945|Drug|Placebo|Oral placebo
15801024|NCT04442932|Device|Blood Collection|K3-EDTA venous whole blood 9 mL 1 venous draw
15801025|NCT04442919|Drug|Ticagrelor followed with Methoxyflurane|patients who received ticagrelor followed with inhaled methoxyflurane due to unstable angina
15801026|NCT04442919|Drug|Ticagrelor followed with Morphine|patients who received ticagrelor followed with intravenous morphine due to unstable angina
15801027|NCT04442919|Drug|Ticagrelor alone|patients who received ticagrelor without any analgesia due to unstable angina
15801028|NCT04442906|Drug|Dexmedetomidine|Group BD received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml dexmedetomidine (100 ug).
15801029|NCT04442906|Drug|Fentanyl|Group BF received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 fentanyl (50 ug)
15801030|NCT04442906|Drug|Bupivacain|Group B received Intra-articular injection of 20 ml bupivacaine 0.25%+ 1 ml saline.
15801031|NCT04442893|Behavioral|Rumination-Focused Cognitive Behaviour Therapy|Rumination-Focused Cognitive Behavioural Therapy(RFCBT) is based on a differentiation between functional and dysfunctional styles of perseverative thinking with the helpful style characterized as a concrete, process-focused and specific style of thinking and the idea that rumination is a habit maintained by negative reinforcement. In line with the theoretical assumptions, RFCBT combines strategies from behavioral activation with strategies to foster concrete, process-focused and specific thinking.
15801222|NCT04441216|Other|Rhizoma Coptidis, Radix Astragali and Flos Lonicerae|granule
15801032|NCT04442893|Other|Health Education programme|Health education programme would be any planned activity or set of activities aimed at increasing health literacy and developing life skills conducing to health (e.g. decision making, problem solving, critical thinking, interpersonal skills, stress management, coping with emotions).
15801033|NCT04442867|Other|Case management|Based on the clients' problems, individualized and specific health education such as recognition of the early signs and symptoms of an exacerbation or deterioration of disease condition, the frequency, dosage, duration of each health-promoting activity that was of therapeutic value, and the techniques required to perform these activities will be provided by the Nurse Case Manager.
15801034|NCT04442867|Other|Social call|Provide social call to participants, such as ask the participants what TV program do you like most, and how are you recently.
15801035|NCT04442854|Other|cognitive behavioral group therapy|A 8-session cognitive behavior group intervention tailor-made for Mainland Chinese university students in Hong Kong
15801036|NCT04442841|Biological|Hepatitis B vaccine|It may be GSk or MSD vaccine
15801037|NCT04442828|Diagnostic Test|Use of 3D echocardiography in patient follow-up|Patients will undergo clinical and echocardiographic examination including detailed 3D echocardiography at study inclusion and at least one follow-up visit.
15801038|NCT04442802|Procedure|Percutaneous transluminal angioplasty|Under local anesthesia the percutaneous arterial access will be created. Digital subtraction angiography of the whole limb will be performed. Occlusive-stenotic lesion of the superficial femoral and / or popliteal artery will be crossed with a guidewire. The plain old (non drug-eluting) will be positioned in the affected arterial segment and inflated up to nominal pressure. After balloon deflation and extraction the completion angiography will be performed. Presence (yes/no) and severity (grades A-B or C-F according to NHLBI classification) of dissection will be assessed independently by 3 study investigators basing on DSA images in 2 directions. Decision to classify the dissection as severe (grade C-F) and to perform the bailout stenting will be done by the agreement between at least 2 from 3 investigators.
15801039|NCT04442776|Behavioral|D-AIP|Intervention on change motivation, insight, medication adherence, drug consumption abstinence or reduction, therapeutic alliance, hopelessness and anxiety
15801040|NCT04442763|Device|Densah Burs|osseodensification method
15801041|NCT04442763|Device|Standard drills|conventional drilling
15801042|NCT04442750|Procedure|Erector spinae plane block Technique|The patient will be placed in Lateral Decubitus with a surgical side upwards. A curvilinear array ultrasound probe will be placed in a transverse orientation at L4 level to identify the tip of the L4 transverse process. The tip of the transverse process will be centered on the ultrasound screen and the probe will be then rotated into a longitudinal orientation 2-3 cm lateral to vertebral column. The lumbar skin region will be sterilized, local infiltration of the skin and subcutaneous tissue will be applied by 2-3ml of lidocaine 2%. Then, using ultrasound guidance, A 38-mm 22-gauge (22-G, 50-mm 'Stimuplex A'; BBraun, Melsung, Germany) regional block needle will be advanced in plane to the ultrasound beam in a cranial-to-caudal direction until contact will made with the L4 transverse process. Local anesthetic solution will be injected and its type will be selected according to the studied group and patients were placed in a supine position and general anesthesia will be started.
15801043|NCT04442750|Procedure|General anesthesia|"Induction of general anaesthesia will be performed using a regimen of IV 2 μg/kg fentanyl and propofol IV 2 mg /kg. Tracheal intubation will be facilitated using 0.5 mg/kg IV of rocuronium.
~Anaesthesia will be maintained with inhaled sevoflurane 1-1.5% in oxygen enriched air (FiO2=0.5). Maintenance doses of rocuronium o.1 m\kg will be provided every 30 minutes.
~Rescue analgesia of fentanyl 1 μg/kg will be given if the mean arterial blood pressure or heart rate rises above 20% of baseline levels.
~At the end of surgery, residual neuromuscular blockade will be reversed using neostigmine (0.05 mg/kg) and atropine (0.02 mg/kg), and will extubation be performed after complete recovery of the airway reflexes."
15801044|NCT04442750|Drug|Bupivacaine 0.5%|The patient will receive 30ml bupivacain 0.5% in erector spinae block
15801045|NCT04442750|Drug|Bupivacaine 0.375%|The patient will receive 30ml bupivacain 0.375% in erector spinae block
15801046|NCT04442750|Drug|Bupivacaine 0.25%|The patient will receive 30ml bupivacain 0.25% in erector spinae block
15801050|NCT04442724|Procedure|Fiducial marker placement|placement of 24k gold fiducial markers surrounding the tumor site, at time of primary or re-staging bladder tumor resection
15801051|NCT04442724|Diagnostic Test|Multiparametric MRI (mpMRI)|In this study, mp-MRI is defined as MRI that includes T1 & T2 weighted sequences, diffusion weighted sequences, and Dynamic contrast enhanced (DCE) MRI sequences.
15801052|NCT04442698|Procedure|Mini-Gastric Bypass Original Technique|Follow up of the Surgical procedure outcomes in diabetics. Procedure Mini-Gastric Bypass Original Technique
15801053|NCT04442672|Procedure|acute compartment syndrome model of health volunteer|the acute compartment syndrome model of health volunteer is induced by pressurizing the calves by the cuff, and the cuff is inflated and pressurized to a pressure value of 20, 30, 40, 50, 60, 70, 80 mmHg. the pressure inside the cuff was up to 10 s during pressurization and maintained stable for 1 min, measured and the above indicators were recorded within 3 min.
15801054|NCT04442672|Procedure|sham|surrounding the cuff but not inflate it.
15801055|NCT04442659|Diagnostic Test|pre hospital triage tool|EMS workers fill in an application containing 10-13 vclinical items
15801056|NCT04442646|Behavioral|multidisciplinary lessons|the multidisciplinary lessons will be conducted by study staff, formed by pneumologist, nurse, biologist and respiratory therapist once a week within 1 month after randomization. Study staff will deal with the following topics: asthma physiopathology, recognition of asthma symptoms and exacerbation, educational interventions on therapy and device, nutritional counselling if necessary. Patients will receive a paper diary for symptoms and an expiratory pick flow meter (PFM) to be done twice a day
15801057|NCT04442633|Drug|Glutamine Cap/Tab|Glutamine Capsules: One capsule three times daily on an empty stomach for one month
15801059|NCT04442633|Drug|Kenacort in orabase|Kenacort in orabase: applied two to three times a day for 3 weeks followed by tapering the following 9 weeks until a maintenance dose of two to three times a week is reached
15801060|NCT04442620|Other|Physical activity and Mediterranean Diet (PA-MD)|Physical Activity plus caloric restricted Mediterranean diet
15801061|NCT04442620|Other|High meal frequency of Mediterranean Diet (HMF-MD)|High meal frequency of unaltered Mediterranean diet
15801062|NCT04442620|Other|Control diet (CD)|Control Diet
15801063|NCT04442607|Device|artificial intelligence image processing|Patients will undergo a standard colonoscopy performed by a trained endoscopist. A second observer, who is not a trained endoscopist, will follow the procedure on a bedside AI-tool to count the number of detections made by the AI system and categorize the results into positive or negative results as follows (1) true positive, (2) false negative or (3) false positive.
15801064|NCT04442594|Procedure|virtual reality session|"The virtual reality sessions will take place in a quiet setting twice a week in the living or hosting residence. The sessions will be hold over a period of time of 6 weeks.
~The virtual environment will change every 3 weeks in order to avoid the phenomenon of habituation."
15801065|NCT04442581|Drug|Cabozantinib S-malate|Given PO
15801066|NCT04442581|Biological|Pembrolizumab|Given IV
15801067|NCT04442568|Other|ERAS|early mobilisation, early oral intake, early discharge
15801068|NCT04442555|Dietary Supplement|HVMN Ketone Ester|Commercially available ketone supplement
15801069|NCT04442555|Dietary Supplement|Maltodextrin|Commercially available maltodextrin supplement
15801070|NCT04442542|Other|Respiratory muscle training 1 (Experimental Group)|"The participant must perform a series of exercises that will be the same for the two groups in this investigation. In addition to the exercises, this group will use the incentive inspirometer device with a new method created by the main author called the Method JaPer.
~For the method JaPer, the participant sits and holds the device. Then put the mouthpiece of the inspirometer in the mouth. Be sure to make a good seal on the mouthpiece with your lips. And exhale normally until you run out of air. And after that, inhale slowly as much as possible. This maximum value will be taken as an indicative parameter of its maximum inspiratory capacity and 50 and 80% for 1 set of 10 repetitions at 50% of their maximum value, 2 sets of 10 repetitions at 60% of its maximum capacity and ends with 1 series at 80% of its maximum capacity. It is highlighted that in each series before finishing and without stopping to rest, the participant must do 5 repetitions at 100% maximum capacity"
15801071|NCT04442542|Other|Respiratory muscle training 2 (Control Group)|Training of respiratory muscles under the protocol of conventional use. Which is that the participant sits and holds the device. Then put the mouthpiece of the inspirometer in the mouth. Be sure to make a good seal on the mouthpiece with your lips. And exhale (exhale) normally until you run out of air. And after that, inhale (inspire) slowly as much as possible. Repeat 10 times and use these indications for 3 sets. In addition, participants must perform the same breathing exercises that are identical for experimental group.
15801072|NCT04442529|Behavioral|Mothers and Babies (MB)|Mothers and Babies is an evidence-based postpartum depression prevention intervention. It consists of 12 sessions which each last between 15-20 minutes. Intervention sessions are to be delivered either in person or by phone. The intervention is based on principles of cognitive-behavioral therapy (CBT).
15801073|NCT04442516|Other|Questionnaire, sampling of blood, urine and saliva|We are following patients who are receiving Cisplatin as part of their cancer therapy.
15801076|NCT04442490|Drug|SAGE-217|SAGE-217 oral capsules.
15801077|NCT04442490|Drug|Placebo|SAGE-217 matched-placebo oral capsules.
15801078|NCT04442477|Dietary Supplement|Enriched Protein Fractions|Enriched protein fractions
15801079|NCT04442477|Dietary Supplement|Protein Fraction|Protein fractions
15801080|NCT04442464|Device|Scleral Lens|15.0 mm diagnostic spherical rigid contact lens
15801081|NCT04442451|Other|Control Exercise|Each participant will attend 3 sessions per week for 8 weeks. Participants will perform low-load knee extension resistance training (20% of 1-RM) without blood flow restriction on the designated leg for 4 sets of contractions with 15 contractions per set of contractions with a 30 second rest between each set of contractions.
15801082|NCT04442451|Other|Blood Flow Restriction Exercise|Each participant will attend 3 sessions per week for 8 weeks. Participants will perform low-load knee extension resistance training (20% of 1-RM) with blood flow restriction on the designated leg for 4 sets of contractions with 15 contractions per set of contractions with a 30 second rest between each set of contractions.
15801083|NCT04442438|Other|Monthly moral case deliberation|Once per month, ICU professionals will take part in moral case deliberation. As part of the intervention, two or three ICU professionals (physicians and nurses) are tasked with selecting a case for moral discussion. Moral case deliberation is attended by around thirty individuals per month per unit. A feedback system will be developed used to spread the knowledge/insights from the case deliberation to all professionals in the unit.
15801084|NCT04442412|Drug|Vitamin D3 (Cholecalciferol)|patients in the Experimental arm (Arm B) will receive also a prephase therapy with VitD and a supplementation of VitD during the intere period of immunochemotherapy according to a prefixed schedule. Choice of type of immunochemotherapy will not rely on Comprehensive Geriatric Assessment (CGA) result, but treatment at reduced doses with R-miniCHOP is highly recommended option for UNFIT and FRAIL patients.
15801085|NCT04442412|Drug|RCHOP o R-miniCHOP at standard doses|"Patients on both arms receive pre-treatment with prednisone oral before 6 cycles of 21 days each of immunochemotherapy with RCHOP
~o R-miniCHOP at standard doses"
15801086|NCT04442399|Behavioral|Family Connections|Ten intervention sessions were covered, ranging form understanding HIV and to handling stigma and discrimination.
15801087|NCT04442386|Other|Prospective study with two measurement points investigating the impact of viral mitigation protocols on parental burnout|Prospective study with two measurement points investigating the impact of viral mitigation protocols on parental burnout
15801088|NCT04442373|Diagnostic Test|Rotational thromboelastometry|1.8 ml blood sample
15801089|NCT04442360|Behavioral|Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health|Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health
15801223|NCT04441216|Other|Rhizoma Coptidis, Radix Astragali and Flos Lonicerae, Ophiopogonis Radix|granule
15801090|NCT04442347|Biological|ARCT-810|ARCT-810 is an investigational medicinal product comprising Ornithine Transcarbamylase (OTC) mRNA formulated in a lipid nanoparticle (LNP) under development.
15801091|NCT04442347|Other|Placebo|The placebo for this study is 0.9% sterile saline.
15801092|NCT04442321|Other|PENS plus exercise|"The technique will be performed ultrasound-guided on the radial nerve, the places of the needle's insertions will be the following:
~Needle will be placed at under the lateral intermuscular septum between the triceps brachii and brachialis, approximately 10cm superior to the lateral epicondyle
~Needle will be placed at the upper third of the forearm on the posterior interosseous nerve after passing the arcade of Froshe
~The percutaneous electrical stimulation will be realized with a transcutaneous electric nerve stimulation (TENS) current:
~TENS Frequency 2 Hz
~TENS Pulse width - 250 microseconds
~Duration - 30 minutes.
~TENS Intensity - Increased at an intensity of visible motor response of the innervated musculature and maximal tolerable intensity.
~Administration - One per week
~Self-management loaded exercises prescribed by a physical therapist, two times per week."
15801093|NCT04442321|Other|Sham PENS plus exercise|"The technique will be performed ultrasound-guided on the radial nerve, the places of the needle's insertions will be the following:
~Needle will be placed at under the lateral intermuscular septum between the triceps brachii and brachialis, approximately 10cm superior to the lateral epicondyle
~Needle will be placed at the upper third of the forearm on the posterior interosseous nerve after passing the arcade of Froshe
~The electrical current will not be working, and the needles will be placed during 30 minutes:
~- Administration - One per week
~Self-management loaded exercises prescribed by a physical therapist, two times per week."
15801094|NCT04442295|Drug|STK-001 - Single Ascending Doses|Experimental : Single Ascending Doses - STK-001 drug product is an antisense oligonucleotide administered as an intrathecal injection. Three dose levels will be evaluated ( 10mg, 20mg and 30mg ).
15801095|NCT04442295|Drug|STK-001 - Multiple Ascending Doses|Experimental : Multiple Ascending Doses - STK-001 drug product is an antisense oligonucleotide administered as an intrathecal injection. Two dose levels will be evaluated ( 20mg and 30mg ).
15801096|NCT04442269|Drug|dupilumab|Single-use prefilled glass syringe administered by subcutaneous injection.
15801097|NCT04442269|Drug|Placebo|Matching placebo
15801098|NCT04442256|Drug|Dupilumab|All patients will be administered subcutaneous doses of dupilumab in a biweekly fashion.
15801099|NCT04442230|Biological|NasoVAX|NasoVAX consists of replication-deficient adenovirus vectors in suspension
15801100|NCT04442230|Other|Placebo|Normal saline
15801101|NCT04442217|Behavioral|Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health|Prospective study with two measurement points investigating the impact of viral mitigation protocols on mental health
15801102|NCT04442204|Other|Prospective study across two time-points examining the impact of viral mitigation protocols on mental health|Prospective study across two time-points examining the impact of viral mitigation protocols on mental health
15801103|NCT04442191|Biological|Convalescent plasma|This study will use convalescent plasma collected from those who have previously had COVID-19 and have been shown to have cleared the infection and made antibodies against the virus.
15801104|NCT04442191|Biological|Placebo|The placebo arm of this study will use fresh frozen plasma that presumably does not contain antibodies against COVID-19.
15801105|NCT04442178|Drug|CYT107|IM administration at 10μg/kg twice a week for three weeks and up to 7 administrations according to Hospital length of stay
15801106|NCT04442178|Drug|Placebo|IM administration at 10μg/kg twice a week for three weeks and up to 7 administrations according to Hospital length of stay
15801107|NCT04442152|Behavioral|MenCare+/Bandebereho fathers'/couples' group education|MenCare+/Bandebereho is a 3 year project to engage men in maternal, newborn and child health (MNCH) and in sexual and reproductive health in Rwanda. A core component of the project is fathers'/couples' group education. The target participants were first-time parents or parents of young children living in 16 rural and semi-urban sectors selected by the implementing partner in collaboration with local authorities. The MenCare+/Bandebereho fathers'/couples' group education engages men in 15 weekly sessions of group discussion, critical reflection and interactive activities led by a trained facilitator using a curriculum developed by RWAMREC and Promundo and approved by the Rwandan Ministry of Health, adapted from the Program P Manual. Men's partners participate in 6-8 sessions. The sessions focus on men's role in MNCH, family planning, sharing household responsibilities, intimate partner violence, conflict resolution, family budgeting, and gender equality.
15801108|NCT04442139|Other|Mini-Gastric Bypass|Mini-Gastric Bypass bariatric surgery
15801109|NCT04442126|Biological|NM21-1480|Trispecific anti-PD-L1/anti-4-1BB/anti-Human Serum Albumin (HSA) single-chain Fv fusion protein
15801110|NCT04442113|Procedure|Pulmonary vein isolation plus ablation guided by novel STAR mapping™|Catheter ablation for persistent AF consisting of pulmonary vein isolation plus additional ablation guided by the novel STAR mapping™ software on a computer device.
15801111|NCT04442113|Procedure|Pulmonary vein isolation|Catheter ablation for persistent AF consisting of pulmonary vein isolation (the standard treatment for AF)
15801112|NCT04442100|Procedure|valve prosthetics|"prosthetics of heart valves with dentures MedEng-Bio"
15801113|NCT04442087|Biological|Serology SARS-CoV2|Collect serum for Serology SARS-CoV2 at inclusion
15801114|NCT04442087|Behavioral|Data collection|Collect clinical and demographic data, habitus, Lifestyle Counseling at inclusion
15801115|NCT04442061|Device|Transcranial magnetic stimulation|"Before the stimulation, identification of a motor hotspot and active motor threshold (AMT) will be performed. The TMS will be applied on the intermittent theta-burst modality (iTBS), i. e., 2 s of TBS trains (30 pulses) repeated every 10 s for 190 s, with a total number of 600 pulses (Huang et al, 2005). The whole TMS session, including preparation, will last up to 1h.
~The sham TMS follows the same procedure of the active TMS without stimulating cortical tissue"
15801116|NCT04442061|Device|MRI|Anatomical and functional images will be acquired and review by an experienced neuro-radiologist.
15801117|NCT04442061|Device|Neuronavigation|The neuronavigation system will allow to guide the stimulation using the individual anatomical MRI acquired with MRI, and to record the position and orientation of the coil during successive stimulations
15801118|NCT04442061|Device|Eye-tracking|Eye movements and follow a person's gaze will be recorded during visualization of stimuli presented in the screen by analyzing images of the eye captured by an infrared camera
15801119|NCT04442061|Genetic|Salivary samples|The DNA will be extracted from the salivary sample to genotyping analyses on the BDNF (Val66Met) and COMT (Val158Met) polymorphism
15801120|NCT04442061|Other|Clinical scales|CGI, E-CAR and ABC will be used for behavior and clinical evaluation
15801121|NCT04442048|Biological|IMM-101|Three doses of IMM-101 on days 0, 14, and 45.
15801122|NCT04442048|Other|Observation|No active treatment. Observation only
15801123|NCT04442035|Behavioral|5-element music therapy|participants were treated by TCM five-phase music therapy for not less than 30 minutes per day, and group music therapy was performed every three weeks. In addition, the therapeutic schedule is composed of treatment time (1pm-2pm, 9pm-11pm), frequency treatment (two times a day), intervention (10-15 minutes in the afternoon, 30 minutes in the evening) and content (individuals: dialectical selection of music; groups: community singing, every three weeks).
15801124|NCT04442022|Drug|Selinexor (combination therapy)|Dose: 40 mg on Days 1 and 8 of each 21-day cycle for up to 6 cycles; Route of administration: oral
15801125|NCT04442022|Drug|Selinexor (combination therapy)|Dose: 60 mg on Days 1 and 8 of each 21-day cycle for up to 6 cycles; Route of administration: oral
15801126|NCT04442022|Drug|Selinexor (combination therapy)|Dose: Selected dose of selinexor (from Phase 2) on Days 1 and 8 of each 21-day cycle for up to 6 cycles; Route of administration: oral
15801127|NCT04442022|Drug|Placebo matching for Selinexor (combination therapy)|Dose: Placebo matching for selected dose of selinexor (from Phase 2) on Days 1 and 8 of each 21-day cycle for up to 6 cycles; Route of administration: oral
15801128|NCT04442022|Drug|Rituximab (combination therapy)|Dose: 375 milligram per meter square (mg/m^2) on Day 1; Route of administration: intravenous (IV)
15801129|NCT04442022|Drug|Rituximab (combination therapy)|Dose: 375 mg/m^2 on Day 1; Route of administration: IV
15801130|NCT04442022|Drug|Gemcitabine (combination therapy)|Dose: 1000 mg/m^2 on Days 1 and 8; Route of administration: IV
15801131|NCT04442022|Drug|Dexamethasone (combination therapy)|Dose: 40 mg (20 mg if patient is more than 70 years old) on Days 1, 2, 3, and 4; Route of administration: oral or IV
15801132|NCT04442022|Drug|Cisplatin (combination therapy)|Dose: 75 mg/m^2 on Day 1; Route of administration: IV
15801133|NCT04442022|Drug|Selinexor (continuous therapy)|Dose: 60 mg QW for each 28-day cycle until PD; Route of administration: oral
15801134|NCT04442022|Drug|Placebo matching for Selinexor (continuous therapy)|Dose: Placebo matching for 60 mg selinexor QW for each 28-day cycle until PD; Route of administration: oral
15801135|NCT04442009|Other|Group SCPB|In group SCBP, SCBP block will be performed. Patients will be administered dexketoprofen 50 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.
15801136|NCT04441996|Biological|Therapeutic plasma exchange (TPE)|Participants will receive two treatments of TPE with frozen plasma (FP) replacement on two sequential days (Day 2 and Day 3). All procedures will be performed by the apheresis staff at the hospital sites, following institutional standard operating procedures. FP will be obtained from American Red Cross or LifeSouth Community Blood centers.
15801137|NCT04441996|Other|Standard of care|Participants will continue to receive standard of care and be closely monitored by ICU team for any change in clinical status, and any adverse events directly related to study intervention will be reported to the study investigator.
15801138|NCT04441983|Diagnostic Test|7 Tesla MRI of the foot|7 Tesla MRI
15801139|NCT04441970|Procedure|Neutral position|The cuff pressure will be recorded at the neutral head position.
15801140|NCT04441970|Procedure|Head extension position|The cuff pressure will be recorded at the head extension position.
15801141|NCT04441970|Procedure|Head flexion position|The cuff pressure will be recorded at the head flexion position.
15801142|NCT04441970|Procedure|Head rotation position|The cuff pressure will be recorded at the head rotation position.
15801143|NCT04441957|Device|Endovenous Mechano- Chemical Ablation|The Flebogrif™ catheter (Balton® Sp. z o.o., Warsaw, Poland) represents endoluminal Non Thermal Non Tumescent devices designed to cause occlusion (fibrosis) of the target vein through the combined mechanical and chemical damage to its endothelial lining with retractable cutters and foamed sclerosant.
15801144|NCT04441944|Other|Telemedicine|Use of provider-to-provider telemedicine
15801145|NCT04441931|Drug|LY3832479|Administered IV.
15801146|NCT04441931|Drug|Placebo|Administered IV.
15801147|NCT04441918|Combination Product|JS016 (anti-SARS-CoV-2 monoclonal antibody)|JS016 (anti-SARS-CoV-2 monoclonal antibody)
15801150|NCT04441892|Device|QTc Meter|Development and evaluation of an inexpensive diagnostic device (the QTc Meter) to support simplified widespread screening in the primary care environment for both congenital long QT syndrome (LQTS) and acquired/drug induced-LQTS.
15801151|NCT04441879|Behavioral|Blended Be a Mom|Blended Be a Mom is a cognitive-behavioral blended intervention for the treatment of postpartum depression. It consists of 13 weeks of face-to-face and online sessions, each session targeting a specific thematic content, and providing participants with both information and specific therapeutic strategies (with a strong focus on cognitive-behavioral techniques) to address each thematic content.
15801152|NCT04441879|Other|Treatment as usual (TAU)|Treatment as usual provided in primary care, including medication and psychotherapy.
15801153|NCT04441866|Diagnostic Test|Automated algorithms|Automated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy
15801154|NCT04441866|Diagnostic Test|Standard technique|Standard ultrasound examination without use of automated algorithms for measuring fetal biometry, and for the reconstruction of standard planes of fetal anatomy
15801155|NCT04441853|Other|YouTube video|Tutoral session on using YouTube personal stories on older people
15801156|NCT04441853|Other|Control|Tutorial session with same content without Youtube video
15801157|NCT04441840|Dietary Supplement|Active Probiotic Culture|Both conditions matched in appearance and serving size
15801158|NCT04441840|Dietary Supplement|Inactive Probiotic Culture|Both conditions matched in appearance and serving size
15801159|NCT04441827|Other|breathing exercise|Pranayama Group Breathing Exercises Step One:Focusing on breathing (1 minute) Step Two: Alternative nasal breathing (3 minutes) Step Three: Refreshing breath (3 minutes) Step Four: Humming bee breath (2 minutes) Step Five: Focusing on breathing (1 minute)
15801160|NCT04441801|Other|stretching exercise|Static stretching consists of stretching a muscle (or group of muscles) to its farthest point and then maintaining or holding that position
15801161|NCT04441788|Drug|ION-827359|ION-827359 administered by oral inhalation
15801162|NCT04441788|Drug|Placebo|Placebo administered by oral inhalation
15801164|NCT04441762|Drug|Intravenous Ketorolac Tromethamine|30 mg ketorolac single dose
15801165|NCT04441762|Drug|Intranasal Ketorolac Tromethamine|30 mg ketorolac single dose
15801166|NCT04441749|Device|Images acquired by needle-based Confocal Laser Endomicroscopy (nCLE)|Patients who are scheduled to undergo Robotic Navigational Bronchoscopy for a peripheral lung lesion will be enrolled. During bronchoscopy, confocal images will be captured using Cellvizio 100 Series Confocal Laser Imaging systems and their Confocal Miniprobes (Mauna Kea Technologies Paris, France). The Cellvizio system and miniprobes are FDA approved by 510(k) for use in through the respiratory tracts by endoscopy or endoscopic accessories. Only images and needle aspiration/ biopsy results from the expansion phase (20 patients) will be analyzed
15801167|NCT04441736|Device|High flow nasal cannula|Device gives high flow oxygen comparable to non invasive ventilation
15801168|NCT04441723|Device|Osteosynthesis with Gamma 3 nail , using a dynamic lag screw as a proximal fixation.|Closed reduction and surgical stabilization of intertrochanteric hip fractures using Gamma 3 nail , with dynamic lag screw as proximal fixation
15801169|NCT04441723|Device|Osteosynthesis with Gamma 3 nail , using a static lag screw as a proximal fixation.|Closed reduction and surgical stabilization of intertrochanteric hip fractures using Gamma 3 nail , with static lag screw as proximal fixation
15801170|NCT04441710|Other|Questionnaire|Participants will be invited to complete a detailed questionnaire to collect prospectively and retrospectively data around the CoViD19 serological screening.
15801171|NCT04441697|Diagnostic Test|Multiple sleep latency tests|The investigators measure the objective sleepiness by recording the electro-encephalogramm during four experimental diurnal naps. They also perform a nocturnal polysomnography prior to the tests for a better interpretation.
15801172|NCT04441684|Diagnostic Test|Blood sample for serological test|"Serology tests:
~By LFA-ICT: BIOSYNEX COVID-19 BSS reference SW40005, BIOSYNEX SWISS SA, Fribourg, Switzerland
~ELISA: EDI™ Novel Coronavirus COVID-19 ELISA IgG Kit, Epitope Diagnostics, Inc., San Diego, USA
~Confirmation test by seroneutralization tests developed at the Strasbourg Virology laboratory on whole virus (analyzes performed in a biosafety level 3 laboratory) and by the viral pseudoparticles system, will be performed."
15801173|NCT04441671|Drug|Disodium Pyrophosphate|Absorption trial
15801174|NCT04441658|Biological|Umbilical Cord Mesenchymal Stem Cells|human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group
15801175|NCT04441658|Biological|saline|saline containing human albumin will be infused to the control group
15801176|NCT04441645|Other|Acupressure|acupressure once per day, five times per week, a total of 12 weeks
15801177|NCT04441632|Behavioral|Positive feedback|Participants will submit positive feedback comments to their colleagues (anonymously or signed, participant-dependent) through an anonymous survey link, a minimum of twice weekly to 6 uniquely different individuals over a 4 week period (total minimum 24 unique individuals over the study period).
15801178|NCT04441619|Behavioral|Delayed onset muscle soreness.|Participants will perform a fatiguing exercise protocol for the upper extremity (biceps muscles)
15801179|NCT04441606|Radiation|68Ga-FAPI-04 PET/CT|"Patients will undergo two scans: first a routine FDG PET scan and a FAPI PET scan, within 10 days.
~Scans will be interpreted by board certified Nuclear medicine physicians and board certified radiologists.
~Immunohistochemical analysis with specific staining for FAP will be performed in removed malignant tissues, either at surgery or from biopsy, to assess a possible correlation between the intensity of uptake and the level of FAP expression."
15801180|NCT04441593|Behavioral|Motivational and Cognitive-Behavioral Management for Alcohol and Pain (MCBMAP)|Videoconferencing intervention to reduce alcohol use and chronic pain interference and severity
15801181|NCT04441593|Behavioral|Treatment as Usual|Psychoeducation and Information about Treatment Resources
15801182|NCT04441580|Device|CADe colonoscopy using GI Genius device|We wanted to compare the diagnostic yield obtained by using CADe colonoscopy to the yield obtained by the standard colonoscopy (SC) in a FIT-positive screening population.
15801183|NCT04441567|Other|Right-size clinic visits|The curve created in Phase 1 will be used to guide the number of clinic visits based on PROMs reported by the participants in Phase 2.
15801184|NCT04441554|Diagnostic Test|7 Tesla MRI|7 Tesla MRI of cervical spine
15801185|NCT04441541|Other|Treadmill with auditory feedback|Participants will receive training 3 times per week for 4 weeks (12 sessions).
15801186|NCT04441541|Other|Treadmill with visual feedback|Participants will receive training 3 times per week for 4 weeks (12 sessions).
15801187|NCT04441541|Other|Treadmill with auditory and visual feedback|Participants will receive training 3 times per week for 4 weeks (12 sessions).
15801188|NCT04441541|Other|Treadmill training|Participants will receive training 3 times per week for 4 weeks (12 sessions).
15801189|NCT04441528|Drug|Lid wipes containing terpinen-4-ol and sodium hyaluronate|Lid wipes will be used in 24 patients for 8 weeks and will be discontinued in the following 4 weeks.
15801190|NCT04441528|Drug|Baby shampoo|Baby will be used in 24 patients for 8 weeks and will be discontinued in the following 4 weeks.
15801191|NCT04441515|Device|Ipod with music|music of patient's preference provided 2 hours daily
15801192|NCT04441515|Device|ipod with books to listen|2 hours of daily listening to books
15801193|NCT04441515|Device|ipod only with usual care|participants given device only
15801224|NCT04441203|Device|CardioMems|novel implantable sensor inserted into the right pulmonary artery that measures pulmonary artery pressures (PAP) in patients with HF, the CardioMEMS™ HF System
15801225|NCT04441190|Behavioral|Digital Action Observation Therapy (Digital AOT)|The participants will be asked to observe videos and then practice what the participants observed.
15801194|NCT04441476|Other|Questionnaires|"An online questionnaire (Limesurvey platform) will be made available at 4 different times (M0, M1, M2 and M6).
~The first questionnaires (M0 and M1) will include a component for professional characterization. Generic and specific stress factors related to ICU and the current pandemic and collective and individual defensive strategies will also be collected in M0 and M1.
~At M2 and M6, the traumatic impact of the crisis, burnout, signs of depression and recourse to internal or external support in the department (occupational medicine, support unit) will be collected."
15801195|NCT04441476|Other|psychological and sociological interviews|"conducting semi-directive psychological interviews (40 interviews in M2, 40 interviews in M6).
~sociological interviews: 40 (20 in M1-M2 then 20 in M6) in order to understand the consequences of the epidemic on daily life, both intra-family and micro-social."
15801196|NCT04441463|Biological|Blood sampling for tryptase analysis|"3 bloods test
~One blood sample taking from the mother's vein punction, during the delivery.
~One blood sample tanking from umbilical cord.
~One blood sample taking from the baby in day 3 of life, during the Guthrie test."
15801197|NCT04441450|Drug|[14C]ICP-022|150mg suspension containing 100μCi of [14C]ICP-022
15801198|NCT04441437|Behavioral|Task-oriented training with a dynamic hand splint|In addition to conventional rehabilitation programs (therapy-as-usual), the subject in the splint group received 1-hour task-oriented training with wearing a customized dynamic hand splint, totally 15 times in a duration of one month. The content of task-oriented training contained picking cubes from side to side with three-jaw grasp, lifting the cone to the shoulder height with the cylindrical grip and an extended elbow, picking up pegs and inserting it into the hole with palmar pinch, and grasping a soap to simulate wiping the body. Among the four tasks, two were chosen to train the subjects according to the abilities of subjects.
15801199|NCT04441437|Behavioral|Task-oriented training without a dynamic hand splint|In addition to conventional rehabilitation programs (therapy-as-usual), the subject in the no-splint group received 1-hour task-oriented training, totally 15 times in a duration of one month. The content of task-oriented training contained picking cubes from side to side with three-jaw grasp, lifting the cone to the shoulder height with the cylindrical grip and an extended elbow, picking up pegs and inserting it into the hole with palmar pinch, and grasping a soap to simulate wiping the body. Among the four tasks, two were chosen to train the subjects according to the abilities of subjects.
15801200|NCT04441424|Biological|Convalescent plasma|400 ml of convalescent plasma (plasma taken 2 weeks from the recovered COVID-19 patients) and was transfused over 1-2 hours to the recipients by blood donation set.
15801201|NCT04441424|Drug|Hydroxychloroquin with Azithromycin|The control group of COVID-19 patients were given the conventional therapy approved in Iraq for COVID-19, namely Hydroxychloroquine 400mg PO twice per day for 5 days and Azithromycin once PO 500 mg per day for 5 days.
15801202|NCT04441411|Device|NEMOST system|Minimal invasive double rod posterior Non-Fusion Scoliosis Surgery
15801203|NCT04441398|Drug|Nitazoxanide|Subjects will receive nitazonanide 600 mg TID for 7 days. Treatment can be extended for another 7 days at Investigators discretion.
15801204|NCT04441398|Drug|Placebo|Subjects will receive placebo TID for 7 days. Treatment can be extended for another 7 days at Investigators discretion.
15801205|NCT04441385|Drug|Maraviroc 300 mg|Patients will receive maraviroc 300 mg twice daily for 14 days
15801206|NCT04441385|Other|Standard care therapy|Subjects randomized to control group will be on standard care treatment according to the Ministry of Health and Local Guidelines and Protocols.
15801207|NCT04441359|Other|Supplemented formula|standard infant formula supplemented with 8 g/L prebiotic inulin-type fructans
15801208|NCT04441359|Other|Standard formula|standard infant formula not supplemented with prebiotic inulin-type fructans
15801209|NCT04441346|Radiation|Echocardiography|test that uses high frequency sound waves (ultrasound) to make pictures of your heart.
15801210|NCT04441333|Device|AspivixTM cervical vacuum tenaculum|Traction of the cervix for IUD insertion using the AspivixTM cervical vacuum tenaculum
15801211|NCT04441320|Device|Coated metal ureteral stent(CMUS)|Coated metal ureteral stent aims to treat the patients with refractory ureteral stricture, such as radiation induced ureteral stricture. In this study, CMUS is indwelled to observe the efficacy and safety in the treatment of radiation induced ureteral stricture compared with Double-J stent.
15801212|NCT04441320|Device|Double-J stent(DJS)|Double-J stent is commonly used for treatment of kinds of ureteral stricture. In this study, DJS is indwelled as a controlled group.
15801213|NCT04441307|Behavioral|Healthy Foundations|Healthy Foundations combines elements of a community-based parent education program with additional information about infant and child development, good parenting practices, parent health behavior, and couple support.
15801214|NCT04441307|Behavioral|Family Foundations|A modified version of Family Foundations, an evidence-based preventive intervention for couples during the transition to parenthood, will be implemented to address several aspects of parent and family adjustment, including parent health behavior, particularly alcohol use, and couple relationship dynamics, to promote a healthy parenting environment.
15801215|NCT04441294|Behavioral|ACE-Plus|
15801216|NCT04441281|Procedure|Traction of the cervix for IUD insertion|Limited mobility of the uterine cervix and alignment with the vaginal canal is often required during insertion of an intrauterine contraceptive device (IUD).
15801217|NCT04441268|Procedure|primary IOL implantation|implant IOL in capsular bag after cataract extraction
15801218|NCT04441255|Drug|TAK-788|TAK-788 Capsule.
15801219|NCT04441242|Other|Ambient lighting|Use of ambient lighting (75-150 lux) in endoscopy room.
15801220|NCT04441242|Other|Low lighting|Use of low lighting (<75 lux) in endoscopy room.
15801221|NCT04441229|Behavioral|ABMT mobile application|"After consent/assent, participants will complete 1 hour-long, in-person or remote, baseline study visit at the Multiple Sclerosis Comprehensive Care Center. During this visit, participants will complete baseline study surveys and a brief computerized attention bias assessment and be trained on the use of the ABMT mobile application. Participants will then complete at-home game play 4 days a week, for 30 days, using an iOS mobile device, approximately 10-15 minutes each day. Subjects will complete weekly online study surveys via REDCap or MyCap (Mobile REDCap Application). At the conclusion of participation, participants will complete online end of study surveys via REDCap or MyCap.
~Parents of participants will complete surveys at the baseline visit, followed by online surveys at Week 2 and at the end of study. For participants who are 18 years old or older, parental participation will not be required."
15801226|NCT04441190|Behavioral|Digital Mirror Therapy (Digital MT)|The participants will observe the real-time self-recorded visual illusion, and move their upper limbs as could as possible.
15801227|NCT04441190|Behavioral|Conventional Occupational Therapy|The participants will receive upper-limb training without providing videos for observing neither providing them mirror illusions of movements.
15801228|NCT04441177|Device|PlayStation®VR training|Participants in the study group receive conventional rehabilitation therapy over 50 minutes on weekdays and 7 sessions (flexible schedule in different day) of PlayStation®VR of 20 minutes each in the main 16-day study period.
15801229|NCT04441164|Other|Observation of Virtual Actions|If the patient is included in the Virtual Reality group, he/she will be asked to observe Virtual Motor Actions (their own avatar moving in a virtual environment) using a headset once a day for 9 days during 5 minutes, followed by 5 minutes of relaxation performed using soothing music played through headphones.
15801230|NCT04441164|Other|Relaxation|If the patient is included in the Relaxation group, he/she will be offered 10 minutes of relaxation performed using soothing music played in headphones once a day for 9 days.
15801231|NCT04441164|Other|Acceptability questionnaire|It will be asked to complete an acceptability questionnaire (a priori) concerning the use of a Virtual Reality tool intended to improve walking in the ICU. The duration of filling in this questionnaire is estimated at 30 minutes.
15801232|NCT04441164|Other|Observation of Virtual Actions (step 4)|If the patient is included in the Observation of Virtual Actions group, he/she will be asked to observe for 10 minutes once a day for 9 days Virtual Motor Actions (avatar moving in a virtual environment) using a Virtual Reality headset.
15801233|NCT04441164|Other|Performing Virtual Actions|If the patient is included in the group Performing Virtual Actions, he/she will be asked to perform Virtual Actions of the lower limbs by controlling the legs of his avatar (virtual double) in order to move around in a virtual environment for 10 minutes per day, once a day for 9 days.
15801234|NCT04441164|Other|Haptic stimulation|According to the superiority or not of the Realization of Virtual Actions or the Observation of Virtual Actions, we will test the most effective condition of step 4 in combination with haptic stimulation (sensory feedback through vibrators positioned in the lower limbs to give a feeling of walking), once a day for 10 minutes for 9 days.
15801235|NCT04441164|Other|Without haptic stimulation|Without haptic stimulation Depending on the superiority or not of the Realization of Virtual Actions or the Observation of Virtual Actions, we will test the most effective condition of Step 4 in combination without haptic stimulation (without sensory feedback through vibrators positioned in the lower limbs to give a feeling of walking), once a day for 10 minutes for 9 days.
15801236|NCT04441151|Behavioral|Pulmonary rehabilitation therapy|Comprehensive interventions based on comprehensive evaluation and customization of patients, including, but not limited to, exercise training, education and behavioral changes, aimed at improving the physiological and psychological status of patients with chronic respiratory diseases, and urge patients to adhere to health promotion activities for a long time.
15801237|NCT04441138|Drug|Durvalumab|Adjuvant Durvalumab in Poor Risk and/or Elderly Patients With Newly Diagnosed Stage III Non-small Cell Lung Cancer who have completed concurrent, split course chemoradiation without progression of disease
15801238|NCT04441125|Other|Experimental|The mothers in the experimental group will receive oxytocin induction before and after delivery
15801239|NCT04441112|Drug|Ketorolac Intraarticular Injection|Injections will be given under ultrasound guidance with one of two possible medications.
15801240|NCT04441112|Drug|Triamcinolone Intraarticular Injection|Injections will be given under ultrasound guidance with one of two possible medications.
15801241|NCT04441099|Drug|NBE-002|NBE-002 will be given intravenously on Day 1 of repeated 21-day cycles.
15801242|NCT04441086|Behavioral|eMotion|Content is delivered within the context of emotion provoking situations common in those recovering from a first MI and in maintaining MVPA. The new on-demand access to asynchronous content sessions provides didactic presentation of video and written material based on weekly needs assessments. Weekly scheduled synchronous video chat sessions, led by a nurse interventionist, will provide further individualization and application of content materials.
15801243|NCT04441086|Behavioral|Healthy Living Active Control|The attention control group will receive their usual cardiac rehabilitation and a comparable dose matched (to that of the eMotion intervention) of healthy living web content and video chat with a nurse.
15801244|NCT04441073|Drug|Lignocaine|preoperative nebulization of lignocaine
15801245|NCT04441073|Drug|Placebo|preoperative nebulization of normal saline (Nacl 0.9%) as a placebo
15801246|NCT04441060|Other|Distress intervention (CBT & Mindfulness-based program)|Distress intervention is not fully developed yet, but we are working on the development of distress intervention based on CBT & Mindfulness-based program.
15801247|NCT04441047|Drug|AlloStim|Living, activated allogeneic Th1-like memory immune cells
15801248|NCT04441034|Drug|Anti-convulsant medications|Anti-convulsants are very commonly used to treat patients with chronic pain.
15801249|NCT04441034|Drug|Anti-depressant medications|Anti-depressants are very commonly used to treat patients with chronic pain.
15801250|NCT04441021|Other|Penicillin Allergy Risk Stratification and Evaluation|This standard of care intervention will provide an antibiotic allergy risk stratification assessment and subsequent amoxicillin oral challenge in patients who stratify as low risk for true allergy
15801251|NCT04441008|Device|Accelerated Intermittent Theta Burst (aiTBS)|High-dose intermittent theta burst administered at a treatment frequency 10x per day, with each treatment session duration 3x standard TMS (1800 pulses). Delivering 50 sessions in 5 days.
15801252|NCT04441008|Device|Electroconvulsive therapy (ECT)|ECT as per standard clinical care and management.
15801253|NCT04440995|Procedure|pectoral nerve block|Patients received standardized general anesthesia. PECS block were applied under vision using blunted tip cannula(27G, 30mm) after surgical resection of breast by operator. 0.25% ropivacaine 10ml was injected into fascia between pectoralis major and minor muscles. 0.25% ropivacaine 20ml was injected into fascia between pectoralis minor and serratus anterior muscles at the level of the third rib. Breast reconstruction is performed after PECS block
15801254|NCT04440982|Combination Product|Study Device Arm|LUM015 will be administered 2 to 6 hours prior to surgery. The LUM Imaging device will be used to assist in the removal of additional tumor tissue.
15801293|NCT04440696|Drug|Lanthanum Polystyrene Sulphonate Powder|D1 was administered once; D2-D12 was administered three times a day; D13 was administered once；
15801255|NCT04440969|Behavioral|Multi-domain intervention|"Participants will undergo dual-task physical exercises and small group activities comprising of quizzes, puzzles and simulate daily living activities that have been gamified (Mindfun and MindGym, ProAge,Singapore). They will also play games on a touch screen device (computerised cognitive training) that aims to improve cognition in the domains of attention, memory, spatial ability, decision making and cognitive flexibility (Memorie, Neeuro, Singapore) while wearing the Senzeband, which emits low frequency signals on the forehead picked up by four individual sensors, allowing participant to play certain games without touching the device but by attention and focus (https://www.neeuro.com/senzeband).
~Dietary guidance will be delivered via a dietary app (Glycoleap). Participants are expected to take photos of their meals daily and upload them onto the app. Certified dieticians will give advice and tips on their choice of food and how to make healthier choices through the app."
15801256|NCT04440956|Drug|64Cu-SARTATE|"200MBq of 64Cu-MeCOSar-Octreotate (64Cu-SARTATE) given as a single bolus intravenous injection and peptide mass will not exceed 10micrograms."
15801257|NCT04440943|Drug|CDX-527|CDX-527 is administered by infusion every 2 weeks
15801258|NCT04440930|Other|White tea|Mouthwash with white tea five to six times a day for nine weeks
15801259|NCT04440930|Other|Salt water with soda|Mouthwash with salt water and soda eight to ten times a day for nine weeks
15801260|NCT04440917|Drug|Camrelizumab|200mg, iv, on day 1, 15, 29, 43
15801261|NCT04440917|Drug|Apatinib Mesylate|250 mg po, qd, 28 days as a cycle, 2 cycles in total
15801262|NCT04440904|Device|CT workstation (Syngo Via VB10B, Siemens, Germany)|Multiplanar reconstruction, curvature plane reconstruction, and volume rendering were used for three-dimensional reconstruction to measure the diameters and lengths of blood vessels and the distances on the body surface
15801263|NCT04440891|Device|TMS stimulation with X-Torp task|TMS-Stimulation with X-Torp task
15801264|NCT04440891|Device|TMS-Stimulation with MindMotion Go|TMS-Stimulation with MindMotion Go
15801265|NCT04440891|Device|TMS-Sham with X-Torp task|TMS-Sham with X-Torp task
15801266|NCT04440891|Device|TMS-Sham with MindMotion Go|TMS-Sham with MindMotion Go
15801267|NCT04440878|Behavioral|Static stretching|Static stretching exercise will be performed under the supervision of a physiotherapist as 30 seconds of stretching and 15 seconds of rest with 10 repetitions, and the individuals will be asked to participate in the exercise actively.
15801268|NCT04440878|Behavioral|Mulligan TSLR technique|Mulligan TSLR will be applied by a physiotherapist in 3 repetitions with the patient in the supine position.
15801269|NCT04440865|Other|Genius® System-assisted Colonoscopy|Genius® Intelligence System is used to assist Colonoscopy
15801270|NCT04440865|Other|Standard Colonoscopy|Standard Colonoscopy without Genius® Intelligence System is performed
15801271|NCT04440852|Behavioral|TEACCH|The Treatment and Education of Autistic and Communication Handicapped Children
15801272|NCT04440839|Other|Telemedicine specialty consultation|Patients with lower extremity wounds due to peripheral artery disease and diabetes mellitus will undergo a specialty consultation with a provider through telemedicine
15801273|NCT04440826|Other|Whole Food Meal|Whole foods meal
15801274|NCT04440826|Other|Processed Food Meal|Processed food meal
15801275|NCT04440826|Other|Gluten-free and lactose-free|Gluten-free and lactose-free food meal
15801276|NCT04440813|Behavioral|Education and Training by Clinicians|Training in the use of PPE and education about the risks of blood exposure.
15801277|NCT04440813|Behavioral|Training and Education from Traditional Healers and Clinicians|Training in the use of PPE and education about the risks of blood exposure.
15801278|NCT04440800|Device|Wearable activity tracker - FitBit|Participants will be given a wearable activity tracker and their daily step count recorded. If there is a reduction from baseline of over 1000 steps, the participant will be contacted and an ambulatory review organised if the reduction is not due to a device compliance issue
15801279|NCT04440787|Procedure|Three point cuff palpation technique|the ETT is finally positioned according to the Three point cuff technique.
15801280|NCT04440774|Biological|CHIK low dose|A single dose of 5x10^9 vp ChAdOx1 Chik
15801281|NCT04440774|Biological|CHIK mid dose|A single dose of 2.5x10^10 vp ChAdOx1 Chik
15801282|NCT04440774|Biological|CHIK high dose|A single dose of 5x10^10 vp ChAdOx1 Chik
15801283|NCT04440774|Biological|ZIKA low dose|A single dose of 5x10^9 vp ChAdOx1 Zika
15801284|NCT04440774|Biological|ZIKA mid dose|A single dose of 2.5x10^10 vp ChAdOx1 Zika
15801285|NCT04440774|Biological|ZIKA high dose|A single dose of 5x10^10 vp ChAdOx1 Zika
15801286|NCT04440774|Biological|Saline placebo|A single dose of isotonic saline solution (0.9%)
15801287|NCT04440761|Other|Observation only|Observation only
15801288|NCT04440748|Device|T-Chair 2.0 Prototype|Participants in the experimental group will perform additional therapy with the T-Chair 2.0. Participants can train in two modes. Participants will either train in the active modus, whereby the participant has to move the seat in a certain direction, or in the passive modus, whereby the participant has to stay in a stable position while the seat is moving underneath the participant. The seat is able to move in mediolateral, anteroposterior, and diagonal and combined directions such as circles or eight-figures. The modus, the type of movement, the range of motion and speed of movement are chosen by the therapist according to the patients' abilities.Training will be coupled with a computer based exercise. During the session preparation time, and time for the questionnaires is needed, thus we expect the actual training time to be on average 30 minutes per training.
15801289|NCT04440748|Other|General Rehabilitation Programme|"The general rehabilitation program that is offered to all patients of Clinic Valens fits the current standards for treatment post-stroke. This program is tailored to the patients needs and consists of a 90 minute so called focus training per day, which includes physical therapy, occupational therapy, resistance training and gait training. According to the patient needs, extra therapy will be given such as robotic therapy, speech therapy and aquatic therapy. The general rehabilitation program in both groups is comparable in content, time and intensity."
15801290|NCT04440735|Biological|DSP107|DSP107 (SIRPα - 4-1BBL) is a bi-functional, trimeric, fusion protein.
15801291|NCT04440735|Biological|Atezolizumab|Atezolizumab is a humanized IgG1 monoclonal antibody that targets PD-L1
15801292|NCT04440709|Device|Brain/neural hand exoskeleton (B/NHE)|The brain/neural hand exoskeleton restores hand motor function by translating user's intention into grasping motions
15801294|NCT04440696|Drug|Lanthanum Carbonate 500 MG|D1 was administered once; D2-D12 was administered three times a day; D13 was administered once；
15801295|NCT04440696|Drug|Placebo|D1 was administered once; D2-D12 was administered three times a day; D13 was administered once；
15801296|NCT04440670|Biological|autologous cord blood mononuclear cells|preterm neonates less than 28 weeks are assigned to receive intravenous autologous cord blood mononuclear cells infusion (5×107cells/kg) within 24 hours after birth
15801297|NCT04440670|Biological|normal saline|preterm neonates less than 28 weeks are assigned to receive normal saline within 24 hours after birth
15801298|NCT04440657|Behavioral|Self-Assured Parenting program|Parents will receive parenting education for 10 weeks
15801300|NCT04440631|Other|no intervention, observational only|no intervention, observational only
15801301|NCT04440605|Procedure|Preoperative staging--D2 gastrectomy--Postoperative staging|Preoperative TNM staging under CT scan plus endoscopy endoscopic biopsy, and postoperative staging after D2 gastrectomy
15801302|NCT04440592|Drug|MT-7117|MT-7117
15801303|NCT04440592|Drug|Placebo|Placebo
15801304|NCT04440579|Procedure|Percutaneous Tibial Nerve Stimulation (PTNS)|PTNS is neuromodulation that uses electricity to stimulate the nervous system, specifically the posterior tibial nerve, and is minimally invasive.
15801305|NCT04440579|Procedure|Sham Percutaneous Tibial Nerve Stimulation (PTNS)|Patients will be connected to the PTNS device but the device will remain off for the entirety of the procedure
15801306|NCT04440579|Procedure|Standard Cystoscopy|Patient will undergo standard cystoscopy
15801307|NCT04440566|Biological|blood sample|30 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
15801308|NCT04440553|Behavioral|Uniform random message delivery|The uniform random intervention group receives feedback and motivational messages chosen from the messaging banks with equal probabilities.
15801309|NCT04440553|Behavioral|Reinforcement learning message delivery|The adaptive intervention group receives messages chosen from the messaging banks by a reinforcement learning algorithm.
15801310|NCT04440540|Behavioral|Dietitian led life style modification intervention|lifestyle changes supervised by dietitians
15801311|NCT04440540|Behavioral|Conventional care (control)|receive routine care
15801312|NCT04440527|Device|Preserflo / Innfocus Microshunt|The Microshunt features an 8.5-mm tube with an outer diameter of 350 µm and a 70-µm diameter lumen. Implantation creates a subconjunctival bleb and lowers intraocular pressure by increasing aqueous humor outflow.
15801313|NCT04440527|Other|Trabeculectomy|Trabeculectomy is the most commonly performed surgical procedure and is considered the gold standard.
15801314|NCT04440514|Procedure|endoscopic preperitoneal repair of parastomal hernia|repair of parastomal hernia after the Sugarbaker principle with TAR and preperitoneal mesh reinforcement
15801315|NCT04440501|Device|Virtual Reality Goggles to provide education a regarding the gluten free diet.|To watch and participate in a virtual reality educational experience regarding the gluten free diet.
15801316|NCT04440488|Biological|ARALAST NP|Partcipants will be randomized to receive ARALAST NP 60 or 120 mg/kg BW/week IV infusion for a total of 104 weeks.
15801317|NCT04440475|Procedure|TAP block|"Tap block description:
~The skin is prepped and draped in a sterile fashion for a lateral to posterior/lateral approach to the Transverse Abdominis Plane (TAP). The Anesthesiologists use ultrasound guidance for all TAP blocks and pre mix 60cc of 0.2% ropivicaine with 10mg of preservative free dexamethasone. After the plane is identified in approximately the mid axillary line, a 17g Tuohy needle is used under ultrasound guidance to enter the potential space from an anterior approach. The needle is visualized in-plane with the ultrasound probe, traversing the exterior and interior oblique muscles and penetrating through the posterior fascia of internal oblique into the transverse abdominal plane. Once the Tuohy is in place, the needle is aspirated and the plane is hydro-dissected using 0.2% Ropivicaine with 10mg of dexamethasone. The anesthesiologist will use 30ml of 0.2% Ropivicaine on each side."
15801318|NCT04440462|Other|Sugar and water solution|2 ml of a water and sugar solution (3 full-teaspoons of granulated sugar dissolved in half glass of water)
15801319|NCT04440462|Other|Sterile water|2 ml of sterile water
15801320|NCT04440449|Behavioral|Lifestyle App|A mobile app used to assist with lifestyle changes
15801321|NCT04440449|Behavioral|Look AHEAD behavior lifestyle intervention|A modified Look AHEAD behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity
15801322|NCT04440449|Behavioral|Abbreviated Look AHEAD behavior lifestyle intervention|An abbreviated Look AHEAD behavior lifestyle intervention with smartphone-based self-monitoring of diet and physical activity
15801323|NCT04440436|Drug|IM19 CAR-T Cells|"IM19 CAR-T cells
~Drug: Fludarabine
~Two days before cell infusion, all patients will be treated with fludarabine for 3 days
~Drug: Cyclophosphamide
~Two days before cell infusion, all patients will be treated with Cyclophosphamide for 3 days"
15801324|NCT04440423|Drug|Clotiazepam 5 mg Test Product Coated Tablets|Investigational Medicinal Product
15801325|NCT04440423|Drug|Clotiazepam 5 mg Reference Product Coated Tablets|Rize (Trademark)
15801326|NCT04440397|Other|xbp-1 - endometriosis patients group|Patients diagnosed with endometriosis by surgery and ultrasound and whose xbp-1 level was examined
15801327|NCT04440384|Other|Functional evaluation|"Patients will complete these forms and tests :
~Box and block test, Purdue peg board, Percival, Nine hole peg, T-GAP, EGF, MAHVIE, DASH, RAND36, CHQ-PF28, CHQ-CF45, CGI-S"
15801328|NCT04440371|Combination Product|Tacrolimus 0.1% ointment twice daily plus NBUVB 3 times weekly|Tacrolimus ointment plus phototherapy NBUVB (Tacrolimus arm)
15801329|NCT04440371|Combination Product|Calcipotriol/Betamethasone ointment plus NBUVB|Calcipotriol/Betamethasone ointment once daily plus NBUVB 3 times weekly
15801330|NCT04440358|Device|Exablate BBBD|BBB opening via Exablate Neuro Type 2 system to deliver carboplatin
15801331|NCT04440358|Drug|Carboplatin|Carboplatin infusion on the day of Exablate BBBD procedure to treat cancerous cells in the brain
15801332|NCT04440345|Drug|IBI362|Administered by subcutaneous injection
15801333|NCT04440345|Drug|Placebo|Administered by subcutaneous injection
15801334|NCT04440319|Behavioral|Intervention group|Intervention group is individual with T2DM who will receive DM Nutrition education for 3 months. There are 75 subjects in Intervention group at 2 districts and 4 Public Health Care (PHC).
15801335|NCT04440306|Procedure|Mini-Gastric Bypass - Original Technique|Mini-Gastric Bypass - Original Technique is widely used form of bariatric surgery and includes a tailored BPLL
15801336|NCT04440293|Other|BBAT|The BBAT was applied by a trained and certified physiotherapist in this area for about an hour, two days a week, as a group therapy. The BBAT program includes movements related to daily activities such as lying, sitting, standing and walking. BBAT focuses on basic movement principles such as postural stability, energy adjustment in movements, comfortable breathing and coordination.
15801337|NCT04440293|Other|CT|The CT program was applied two days a week for about an hour. The CT program includes active range of motion (ROM) exercises, stretching, isometric and resistant strengthening, posture exercises and relaxation training.
15801338|NCT04440280|Drug|N-acetyl cysteine (NAC) 10% solution|N-acetyl cysteine is a sterile, unpreserved eye drop containing 10% (100 mg/mL) of acetylcysteine.
15801339|NCT04440280|Drug|N-acetyl cysteine (NAC) 20% solution|N-acetyl cysteine is a sterile, unpreserved eye drop containing 20% (200 mg/mL) of acetylcysteine.
15801340|NCT04440280|Drug|Visine Dry Eye Relief eye drops|Visine Tears Dry Eye Relief artificial tears ophthalmic solution
15801341|NCT04440267|Drug|vincristine|acute lymphoblastic leukemia (ALL) -based chemotherapy
15801342|NCT04440267|Drug|daunorubicin|acute lymphoblastic leukemia (ALL) -based chemotherapy
15801343|NCT04440267|Drug|cyclophosphamide|acute lymphoblastic leukemia (ALL) -based chemotherapy
15801344|NCT04440267|Drug|L-Asparaginase|acute lymphoblastic leukemia (ALL) -based chemotherapy
15801345|NCT04440267|Drug|prednisone|acute lymphoblastic leukemia (ALL) -based chemotherapy
15801346|NCT04440267|Drug|mercaptopurine|acute lymphoblastic leukemia (ALL) -based chemotherapy
15801347|NCT04440267|Drug|methotrexate|acute lymphoblastic leukemia (ALL) -based chemotherapy
15801348|NCT04440267|Drug|dexamethasone|acute lymphoblastic leukemia (ALL) -based chemotherapy
15801349|NCT04440267|Drug|Tyrosine kinase inhibitor|acute lymphoblastic leukemia (ALL) -based chemotherapy
15801350|NCT04440254|Diagnostic Test|Implantation (subcutaneous) of a marketed miniaturized Holter ECG recording device|Subcutaneously implanted under local anesthesia of the device on the presternal or subclavicular region
15801351|NCT04440241|Procedure|regenerative treatment periimplantitis|"Full thickness buccal and lingual flaps will be performed. After debridement of the defect using hand and ultrasonic instruments and implant surface decontamination using titanium brushes (TiBrush®) and saline Regenerative treatment will be performed only in the intrabony component of type 1 peri-implant defects. Guided bone regeneration using a bone substitute (Bio-oss®) and a resorbable membrane (bio-gide®) will be performed in the intrabony and dehiscenses areas of the defect.
~The surgeon will be blinded to the assignment of treatment until it is time to close the flaps."
15801352|NCT04440228|Behavioral|TeamSTEPPS|"TeamSTEPPS is an evidence-based approach for teams that can be adapted for school mental health.
~Team Strategies and Tools to Enhance Performance and Patient Safety (TeamSTEPPS), has been widely disseminated in health care settings with promising outcomes. TeamSTEPPS is designed to build competencies in the areas of leadership, situation monitoring, mutual support, and communication and has been associated with improvements in teamwork and communication as well as patient outcomes, such as decreased seclusion in psychiatric hospitals."
15801353|NCT04440215|Other|Telerehabilitation and team meetings and team care plans|A mix of home or rehabilitation center visits and telerehabilitation will be planned by the rehabilitation team for a maximum of 16 weeks. Moreover, for each participant enrolled, a multidisciplinary meeting will be organised. The patient/family will participate in the meeting and the decision making process using the telerehabilitation platform. The team will generate an interprofessional individualized treatment plan, aiming for an interprofessional shared decision making process.
15801354|NCT04440215|Other|Usual care|Rehabilitation teams will be instructed to provide care as they have been doing previously. Currently, this translates into no telerehabilitation, and interdisciplinary meetings not systematically organized and/or not involving a complete team of professionals.
15801355|NCT04440202|Behavioral|Conventional sea bream|Participants initially randomized to this intervention arm will be provided with a total of 8 conventional sea bream fillets and will be asked to consume them twice weekly for 1 month. Sea bream fillets will be produced by a fish farming company using standard procedures. Participants will also be instructed to avoid the reception of any medication or dietary supplement and not to change their lifestyle habits (e.g. other dietary habits besides fish consumption, physical activity habits or sleep habits) during the intervention. After a 1-month wash-out period (no fish consumption), participants will cross over to the other intervention arm.
15801356|NCT04440202|Behavioral|Enriched sea bream|Participants initially randomized to this intervention arm will be provided with a total of 8 enriched sea bream fillets, and will be asked to consume them twice weekly for 1 month. Enriched sea bream fillets will be produced by a fish farming company from fish bread with a fraction of bioactive polar lipids extracted from olive oil by-products. Participants will also be instructed to avoid the reception of any medication or dietary supplement and not to change their lifestyle habits (e.g. other dietary habits besides fish consumption, physical activity habits or sleep habits) during the intervention. After a 1-month wash-out period (no fish consumption), participants will cross over to the other intervention arm.
15801357|NCT04440189|Device|GID SVF-2 Device System|The GID SVF-2 Device System is used for harvesting, filtering, separating and concentrating autologous stromal vascular fraction from adipose tissue.
15801360|NCT04440163|Biological|MenABCWY|N meningitidis groups A, B, C, W, and Y vaccine
15801361|NCT04440163|Biological|Saline|Placebo
15801362|NCT04440163|Biological|Trumenba|Bivalent recombinant lipoprotein 2086 vaccine
15801363|NCT04440163|Biological|MenACWY-CRM|Meningococcal group A, C, W-135, and Y conjugate vaccine
15801364|NCT04440150|Procedure|Appendectomy|Open or Laparascopic Surgery
15801365|NCT04440137|Behavioral|Bottle-feeding cessation program|Specific brochure and proper oral hygiene education emphasizing on the benefit of stopping bottle-feeding given to subject
15801395|NCT04439903|Other|Web-based Simulation Tool|Glucose, insulin and meal data from the participants' insulin pump will be collected and entered into the WST, which will generate personalized models of the participants' glucose metabolism to enable replay simulations.
15801366|NCT04440124|Other|Incremental shuttle walk test|All patients were reviewed by a physiotherapist during their pre-assessment clinic one week prior to surgery to complete an incremental shuttle walk test (ISWT). The ISWT was completed according to a standardised protocol and involved patients walking around 2 cones set up 9 metres apart. Patients were asked to cover the distance between the cones in time to auditory cues. Oxygen levels and heart rate were recorded during the assessment with the use of a portable pulse oximeter. The test was stopped when patients could no longer keep pace with the auditory cues or were too breathless to continue. The total distance mobilised was recorded.
15801367|NCT04440111|Other|One year training|"At first, children will make a test to evaluate their pre- intervention basic support life knowledge.
~Secondly, they will receive a theoretical class about BLS, based on European Resuscitation Council Guide 2015.
~After that, they will make a practical workshop on BLS. Finally they will repeat the initial test. The second year, this group will only make the test, they won't receive any theory or practice."
15801368|NCT04440111|Other|Two years training|"At first, children will make a test to evaluate their pre- intervention basic support life knowledge.
~Secondly, they will receive a theoretical class about BLS, based on European Resuscitation Council Guide 2015. After that they will make a practical workshop on BLS.
~Finally they will repeat the initial test. The second year, this group will repeat the same process."
15801369|NCT04440085|Drug|Midodrine Hydrochloride|All patients become standard care resuscitation treatment using liquids and vasoactive drugs in order to get a median arterial pressure ≥ 65 mmHg. Midodrine will be administered according to the evolution of the patient's mean pressure.
15801370|NCT04440085|Drug|Placebo|All patients become standard care resuscitation treatment using liquids and vasoactive drugs in order to get a median arterial pressure ≥ 65 mmHg. Placebo will be administered according to the evolution of the patient's mean pressure.
15801371|NCT04440059|Drug|ICP-022|ICP-022 at a dose of 150mg PO QD
15801372|NCT04440046|Other|Manual therapy thoracic spine|Manual therapy mobilization directed to the costovertebral joint.
15801373|NCT04440046|Other|Manual therapy glenohumeral joint|Manual therapy mobilization directed to the glenohumeral joint.
15801374|NCT04440046|Other|Sham thoracic manual therapy|Sham manual therapy directed to the costovertebral joint.
15801375|NCT04440046|Other|Sham glenohumeral manual therapy|Sham manual therapy directed to the glenohumeral joint.
15801376|NCT04440046|Other|Therapeutic exercise|Therapeutic exercise program consisting on isometric exercise with progressive load.
15801382|NCT04440020|Other|Beverage of Olive Oil Leaves|Beverage of Olive Oil Leaves,Oleuropein
15801383|NCT04440020|Other|Mediterranean Diet|Mediterranean Diet ,for a personal nutrition with the same dietary habits
15801384|NCT04440007|Drug|Abivertinib|Abivertinib maleate is a third-generation EGFR tyrosine kinase inhibitor and BTK Inhibitor. The starting dose is 200 mg p.o. QD for up to 28 days.
15801385|NCT04440007|Other|Standard of Care|Standard of Care as determined by the Investigator
15801386|NCT04439994|Other|hypertonic saline|The participant will be given i.d. in 0.1 mL volumes of a hypertonic saline solution
15801387|NCT04439994|Other|Saline injection|The participant will be given i.d. in 0.1 mL volumes of a saline solution
15801388|NCT04439994|Procedure|Blood sampling|Whole blood samples (5 mL per each time point, a total of 20 mL per subject) will be collected
15801389|NCT04439981|Dietary Supplement|Ice cream|Curcumin extract was added into ice cream
15801390|NCT04439968|Other|Clinical algorithm|In order to maintain cerebral saturations within targeted range, subjects in the targeted Csat arm will undergo clinical interventions based on clinical algorithm. Interventions may include administration of inotropes, fluid resuscitation, transfusion of blood products, and/or adjustment to respiratory support.
15801391|NCT04439955|Drug|CBD|300 mg CBD
15801392|NCT04439942|Other|cardiac magnetic resonance imaging (MRI)|Cardiac MRI is a mandatory examination for Hypertrophic cardiomyopathy patients as it provides important information about the presence of fibrosis which is also directly associated with sudden cardiac death.
15801393|NCT04439929|Biological|TUR01|Administered as a single 40 mg, subcutaneous dose
15801394|NCT04439929|Biological|Adalimumab-EU|Administered as a single 40 mg, subcutaneous dose
15801396|NCT04439890|Drug|Anlotinib hydrochloride capsule|Anlotinib hydrochloride capsule 12mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)
15801397|NCT04439890|Drug|Carboplatin injection|Carboplatin injection AUC 5mg/mL/min, intravenous drip, on Day 1 in 21-day cycle.
15801398|NCT04439890|Drug|Pemetrexed disodium f Injection|Pemetrexed disodium f Injection 500mg / m2, intravenous drip, on Day 1 in 21-day cycle.
15801399|NCT04439890|Drug|Placebo|Placebo
15801400|NCT04439877|Behavioral|Peri-implant disease diagnosis|Diagnosis of peri-implant disease
15801401|NCT04439864|Device|MyIDEA|An educational tablet app that is customized to the patient based on the data in the Electronic Health Record.
15801402|NCT04439838|Drug|BI 1595043|BI 1595043
15801403|NCT04439838|Drug|Placebo|Placebo
15801404|NCT04439825|Drug|Botulinum Neurotoxin|glabella, forehead lines and/or lateral canthal lines
15801405|NCT04439825|Drug|Placebo|Saline solution (preservative free)
15801406|NCT04439812|Other|Observation|The primary aim of this study was to evaluate the influence of positive margins on the tumour's recurrence and OS after gastrectomy for GC. The secondary outcome was to analyse the possible confounding factors that could affect the recurrence and OS after gastrectomy.
15801407|NCT04439799|Drug|Testosterone Cypionate 200 MG/ML|Participants in this group will receive intramuscular testosterone cypionate injections of 1 cc (200mg) once every 14 days for four months.
15801408|NCT04439799|Drug|Intranasal Testosterone|Participant in this group will receive Intranasal testosterone administered using a multi-dose dispenser, as two or three daily doses (5.5 mg per nostril, 11.0 mg single dose) for 4 consecutive months,
15801409|NCT04439786|Drug|placebo|the control group will be given the same volume of saline.
15801410|NCT04439786|Drug|lidocaine|the experimental group will be given 1-1.5mg/kg lidocaine and then 2mg/kg/h
15801411|NCT04439773|Drug|placebo|the control group will be given the same volume of saline.
15801412|NCT04439773|Drug|Lidocaine|the experimental group will be given 1-1.5mg/kg lidocaine and then 2mg/kg/h
15801413|NCT04439760|Procedure|Superior Cervical Ganglion Block|Under X-ray guidance, a 23-gauge radiofrequency top-pole needle with an active tip of 5 mm is inserted for test blockade. The needle is directed at the facet joint of the 3rd and 4th cervical vertebrae.The needle is introduced parallel to the radiographic projection and is projected as a dot approximately 1 cm anterior to the spine. The radiographic projection is then changed to lateral, and the needle is slowly advanced until the tip was situated at the anterior border of the third cervical vertebra. On the anteroposterior projection, the tip of the needle is projected over the lateral part of the facetal column. When the tip of the needle is in position, 0.3 mL of Omnipaque is injected. On the transverse projection, the contrast is distinctly anterior to anterior border of the vertebral bodies, and in the anteroposterior projection, the contrast is seen spreading in a space overlying the facetal column in a cranial as well as caudal direction.
15801414|NCT04439747|Other|Ultrasound, DXA, hormonal tests|Diagnostic tests in selected groups with investigation of revealed hormonal disorders
15801415|NCT04439734|Device|Electromyostimulation|WB-EMS once per week 20 min for 16 weeks
15801416|NCT04439721|Drug|γδT Cell infusion agent|γδT
15801417|NCT04439708|Other|Blood and aqueous humor biomarker of treatment response|Blood analyses and aqueous humor analysis
15801418|NCT04439695|Biological|Low dose|Low dose of KBP-V001
15801419|NCT04439695|Biological|Intermediate dose|Intermediate dose of KBP-V001
15801420|NCT04439695|Biological|High dose|High dose of KBP-V001
15801421|NCT04439695|Biological|Placebo|Buffered Saline Solution
15801422|NCT04439682|Other|Aerobic exercise|Aerobic exercise will be performed to all participants for a single session. Maximum heart rate was calculated for each subject (220 - age) and a heart rate monitor (Polar FT 100, China) will be used to follow subjects' heart rate during aerobic exercise.
15801423|NCT04439669|Device|Sham nrTMS and open phase|"Navigated repetitive TMS treatment (10 sessions during a three-week period) randomized to sham. In the following open phase stimulation the treatment targets are the right S2-contralateral M1-left S2."
15801424|NCT04439669|Device|Active nrTMS and open phase|"Navigated repetitive TMS treatment (10 sessions during a three-week period) randomized to S2. In the following open phase stimulation the treatment targets are contralateral M1 and left S2. If the patient benefited from active S2 stimulation, but the treatment effect faded in follow-up, the open phase stimulation starts with right S2."
15801425|NCT04439656|Diagnostic Test|Eye movement analysis|Eye movements will be analyzed to identify if seizures are present and compared to the EEG read
15801426|NCT04439643|Device|vascuCAP|time to event and phenotype classification model
15801427|NCT04439630|Dietary Supplement|Nopal fractions|Nopal flour were divided in two fractions and mixed in two different test breads
15801428|NCT04439630|Dietary Supplement|Test product without the active components|Test product without the active components
15801429|NCT04439617|Biological|blood examination|use of the remaining 1-2 ml of blood in samples taken as part of routine care to study mitochondrial function
15801430|NCT04439604|Other|regional ventilation monitoring|regional ventilation monitoring
15801431|NCT04439591|Other|Computerised cognitive training|A 12-week bi-weekly group-based computerised cognitive training programme conducted in community centres
15801433|NCT04439565|Genetic|movement|aortic dissection or aneurysm patients this is an observation cohort study about a Non-syndromic Familial Aortic Dissection without intervention.
15801434|NCT04439539|Drug|JNJ-73763989|JNJ-73763989 injection will be administered subcutaneously.
15801435|NCT04439539|Drug|JNJ-56136379|JNJ-56136379 tablets will be administered orally.
15801436|NCT04439539|Drug|PegIFN-alpha-2a|PegIFN-alpha-2a injection will be administered subcutaneously.
15801437|NCT04439539|Drug|Tenofovir disoproxil|Tenofovir disoproxil film-coated tablet will be administered orally.
15801438|NCT04439539|Drug|Tenofovir alafenamide|Tenofovir alafenamide film-coated tablet will be administered orally.
15801440|NCT04439513|Device|Hemostasis|Compression device to achieve hemostasis.
15801441|NCT04439500|Behavioral|Real World Strategy Training|The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
15801442|NCT04439500|Behavioral|Brain Education|The active comparator uses an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants will receive factual information on brain structure and function, age-related cognitive changes, and general brain health issues and will spend time doing non-specific cognitive exercises including crossword and Sodoku puzzles. Homework will consist of reading assignments related to the session topics.
15801443|NCT04439487|Diagnostic Test|Anthropometric measurements during routine preoperative visit|During routine preoperative anaesthetic visit and physical examination the following predictive test measurements are obtained by a research team member not involved in the further assessment of laryngoscopy: score in modified Mallampati test, Thyromental height, Sternomental distance, Thyromental distance, Neck circumference, Mouth opening distance
15801444|NCT04439487|Other|Assesment of intubation parameters during induction of general anaesthesia|During induction of general anaesthesia and intubation research team member not involved in obtaining anthropometric measurements notes Number of intubation attempts, Intubation time, Subjective intubation difficulty, Use of bougie and Need of technique modification.
15801445|NCT04439474|Drug|Vitamin D3|For up to 8 days, 50,000 units of vitamin D3 are given daily to patients in the first group so that the serum level of vitamin D reaches above 30 g / ml.
15801446|NCT04439474|Drug|Routine treatment|In this group, patients receive their usual medications and treatments
15801447|NCT04439448|Radiation|dual-energy X-ray absorptiometry (DEXA) scan|Whole body dual-energy X-ray absorptiometry (DEXA) scan to assess lean and fat mass
15801448|NCT04439448|Other|Carotid and branchial artery ultrasound|Ultrasound to assess carotid plaque and brachial artery flow mediated dilation
15801449|NCT04439448|Diagnostic Test|2-hour oral glucose tolerace test|Ingestion of 75g of glucose syrup with blood collection for glucose and insulin at time 0, 90min and 120min
15801450|NCT04439448|Diagnostic Test|Blood collection|Blood collection for measurement of circulating proteins (cytokines) and isolation of immune cells
15801451|NCT04439422|Behavioral|Short ADHD Intervention|Short, intensive psychological intervention based on CBT and DBT practices
15801452|NCT04439422|Other|Self-help material with limited therapist support|Self-help material from an evidence-based treatment manual for adult ADHD with access to limited therapist support via Internet (control group)
15801453|NCT04439409|Device|Holter electrocardiogram|Holter electrocardiogram will be carried during 7 days to measure heart's electrical activity continuously.
15801454|NCT04439396|Drug|Ketorolac Tromethamine|nonsteroidal anti-inflammatory drug
15801455|NCT04439396|Other|Saline|saline fluid injection
15801456|NCT04439370|Diagnostic Test|Microneurography to measure muscle sympathetic nerve activity (MSNA)|Microneurography is a direct measurement of electrical activity of peripheral sympathetic nerves
15801457|NCT04439370|Diagnostic Test|Baroreflex sensitivity testing|Two arms of the baroreflex that will be tested in this study are sympathetic and cardiovagal. Static baroreflex is tested during baseline resting conditions and dynamic baroreflex is tested during Valsalva maneuvers.
15801458|NCT04439370|Diagnostic Test|Sympathoexcitatory Maneuvers|Cold Pressor Test (CPT) and Upper extremity fatiguing contraction with post exercise circulatory occlusion (PECO) will be performed
15801459|NCT04439370|Diagnostic Test|Blood tests|Serum FSH, estrogen, progesterone, and testosterone will be measured
15801460|NCT04439357|Drug|Trametinib Dimethyl Sulfoxide|Given PO
15801461|NCT04439344|Drug|Binimetinib|Given PO
15801462|NCT04439331|Drug|Defactinib Hydrochloride|Given PO
15801463|NCT04439318|Drug|Trametinib Dimethyl Sulfoxide|Given PO
15801464|NCT04439305|Drug|Dasatinib|Given PO
15801465|NCT04439292|Drug|Dabrafenib Mesylate|Given PO
15801466|NCT04439292|Drug|Trametinib Dimethyl Sulfoxide|Given PO
15801467|NCT04439279|Drug|Trametinib Dimethyl Sulfoxide|Given PO
15801470|NCT04439240|Drug|FGFR Inhibitor AZD4547|Given PO
15801471|NCT04439227|Drug|Adavosertib|Given PO
15801472|NCT04439214|Biological|Nivolumab|Given IV
15801473|NCT04439201|Drug|Palbociclib|Given PO
15801474|NCT04439188|Drug|PI3K-beta Inhibitor GSK2636771|Given PO
15801475|NCT04439175|Drug|Taselisib|Given PO
15801476|NCT04439162|Procedure|retrograde cardioplegia protection|antegrade-retrograde cardioplegia
15801478|NCT04439136|Drug|Afatinib Dimaleate|Given PO
15801479|NCT04439123|Drug|Capivasertib|Given PO
15801480|NCT04439110|Biological|Trastuzumab Emtansine|Given IV
15801481|NCT04439097|Other|Multicomponent physical exercise program associated with a Mediterranean diet|"In this basic structure of each sessions, traditional exercises of mobility, strength, balance and coordination are included with the main objective of improving functional capacities. But, besides, games and some activities are also included with the aim, not only of improving the functional capacity, but also working the cognitive functions to reinforce the global effects.
~The Mediterranean diet will based in these main foods: 1) vegetables; 2) fruits; 3) fish or seafood; 4) legumes; 5) nuts; 6) bread or cereals; 7) white meat; 8) eggs; and 9)olive oil."
15801482|NCT04439097|Other|Usual care|Usual care and participants continue with their life normally, without participating in a standardized exercise program, and they will be instructed to maintain their current physical activity level.
15801483|NCT04439084|Other|Prospective Chart Review|Collected data will include demographic features, clinical characteristics, clinical outcome, medication use, COVID-19-related complications in patients with chronic liver disease.
15801487|NCT04439058|Other|ultrasound guided left stellate ganglion block|"Stellate Ganglion Block (SGB) has several established clinical indications Under complete aseptic precautions an ultrasound guided left stellate ganglion block was performed. (paratracheal technique ) ( ) The patient was placed in the supine position with the head in the neutral position and slightly extended. An initial scanning was done with the ultrasound to identify the structures in this area.
~The US probe was placed at the level of the cricoid cartilage. The transverse process of the sixth cervical vertebra was identified by its prominent anterior tubercle. Also, the longus colli muscle and its overlying prevertebral fascia were sought anterior to the C6 vertebral body and deep to the carotid artery. After skin infiltration with local anesthetic, the needle was inserted from lateral to medial using the in-plane technique. The aim was to inject the local anesthetics deep to the prevertebral fascia and above the longus colli"
15801488|NCT04439045|Biological|VPM1002|VPM1002 is a recombinant BCG (rBCG)
15801489|NCT04439045|Other|Placebo|0.9% sodium chloride
15801490|NCT04439032|Other|NanoBone Bone Graft Substitute|Synthetic, biodegradable bone grafting material that is composed of non-sintered nanocrystalline hydroxyapatite (HA) which is embedded in a silica gel matrix (amorphous SiO2). The ratio of HA/SiO2 has been chosen to optimize the rate of biodegradation for treatment of osseous defects in human bone. NanoBone does not contain any components of animal or human origin, eliminating the possibility of transmission of infection or disease.
15801491|NCT04439019|Other|Lifestyle and dietary modification program|"The OA Optimization Program is a lifestyle and dietary modification program. All Patients will be offered this optional program while they await orthopedic consultation. There is an initial group information session for participants followed by medical assessment which includes medical history and physical examination, a previous dietary history, a readiness for change assessment, and screening for contraindications to the program. The patients will then attend group counselling sessions every 3 months for 1 year, or until their surgical date.Patients are encouraged to attend sessions with a family member. Improvement in Quality of Life measures including pain and disability in patients with severe osteoarthritis, as well as improvements in markers of health such as BMI, waist circumference, blood pressure, medication use in diabetic and hypertensive patients, and markers such as serum lipids and markers of inflammation will be shown."
15801492|NCT04439006|Other|Best Practice|Receive usual care
15801493|NCT04439006|Drug|Ibrutinib|Given PO
15801494|NCT04438980|Drug|Methylprednisolone|-A dose of 120 mg/day of methylprednisolone for 3 days, administered by intravenous infusión
15801495|NCT04438980|Other|Placebo|-An infusion bag of 100 mL of 0.9% saline
15801496|NCT04438928|Dietary Supplement|Elevit Pregnancy 2nd & 3rd Trimester|Once daily micronutrient plus DHA supplementation (Multi-micronutrients and docosahexaenoic acid (MMS) soft gel capsules)
15801497|NCT04438928|Other|Non-Supplement|Control study group of pregnant women non-supplemented with multi-micronutrients and docosahexaenoic acid (MMS) soft gel capsules
15801498|NCT04438915|Behavioral|Effect of Obesity on incidence of Postoperative cognitive in Gynecological Day- Day- case surgery|The effect of obesity on the incidence of postoperative cognitive dysfunction in Gynecological day-case surgery
15801499|NCT04438902|Drug|osimertinib mesylate tablets and anlotinib hydrochloride capsules|osimertinib mesylate tablets 80mg qd and anlotinib hydrochloride capsules 10mg qd day 1-14 of a 21-day cycle
15801500|NCT04438889|Other|Non-interventional|Only routine clinical data, which has already been recorded in the patient's medical chart, will be documented. Any other data assessments (e.g. quality of life analyses such as EQ-5D and QLQ-C30 have been approved by the Ehtikkommission für das Bundesland Salzburg and are optional.
15801501|NCT04438876|Other|Functional Power Training|The exercise intervention encompassed high-velocity movement, balance, and mobility exercises with the use of body weight and resistance bands as resistance. Participants were instructed to move rapidly during the concentric phase and slowly during the eccentric phase when performing the dynamic exercises.
15801502|NCT04438876|Other|Usual care|Participants either continued the usual exercise program provided by their respective community senior activity centers or their personal exercise routine.
15801503|NCT04438863|Diagnostic Test|home spirometry|portable hand-held spirometer to collect and store daily spirometric data (including FVC, FEV1, forced expiratory flow after 25 to 75% of vital capacity has been expelled, and peak flow).
15801504|NCT04438850|Drug|Ivermectin|Patients will be administered a single oral daily dose of approximately 600 μg/Kg (486-679 μg/Kg as rounded to a whole number of tablets), or 1200 μg/Kg (1098-1286 μg/Kg).
15801505|NCT04438850|Other|Placebo|Patients should take placebo orally on an empty stomach with water
15801506|NCT04438837|Drug|Hydroxychloroquine|Hydroxychloroquine post exposure prohylaxis
15801507|NCT04438824|Drug|INCMGA00012|INCMGA00012: 500 mg IV (flat dose) q28 days (+/- 7 days in each cycle)
15801508|NCT04438824|Drug|Palbociclib|Palbociclib:125 mg PO daily for 21 days, followed by 7 days off, q28 days
15801509|NCT04438811|Other|delivery of the spinal anesthetic by a trained medical officer|The delivery of spinal anesthesia by the trained medical officers in 3 rural Indian hospitals will be compared to those delivered by consultant anesthetists in the same hospitals in a non-inferiority analysis.
15801510|NCT04438811|Other|delivery of spinal anesthetic by a consultant anesthetist|The delivery of spinal anesthesia by the trained medical officers in 3 rural Indian hospitals will be compared to those delivered by consultant anesthetists in the same hospitals in a non-inferiority analysis.
15801511|NCT04438798|Other|F Group|In Group F, pregnant females will be preoxygenated with 100% oxygen using a tight-fitting face mask at a rate of 6 L/min for 3 min with end-tidal gas monitoring.
15801512|NCT04438798|Other|H Group|In Group H, high-flow humidified oxygen warmed to 37°C will be delivered through nasal cannula at the rate of 30 L/ min for 30 seconds then 50 liters per minute for a further 150 seconds.
15801513|NCT04438785|Device|The intervention consists of myofunctional therapy (MT) using the AirwayGym app.|Intervention. Patient newly diagnosed with severe OSAHS should perform muscle upper airway exercises using the App AirwayGym 20 minutes a day during 90 days.
15801514|NCT04438772|Other|Check the condition of intubation with LPEC compared with a sham procedure in the general anesthesia|Intubation with Left Paratracheal Esophagus Compression (LPEC) or sham procedure and evaluation of intubation's condition
15801515|NCT04438759|Device|Oncomfort, commercially available Virtual Reality headset|Virtual Reality headset, consisting of headphones with smartphone glasses - see oncomfort.com/en, CE approval conform 93/42/EEC and 2007/47/EEC
15801516|NCT04438746|Behavioral|Emotion discussion|General discussion of emotions; no therapy or training is offered
15801517|NCT04438746|Behavioral|Cognitive Behavioral Affective Therapy|Active training in regulating anger
15801518|NCT04438733|Drug|test-anastrozole tablet (Salutas Pharma GmbH)|Subjects were allocated to one of two groups randomly and equally with a 21-day washout interval between the two periods.All of them were randomized (1:1) to receive anastrozole as a single oral dose of the test drug or a single 1.0-mg oral dose of Arimidex
15801519|NCT04438733|Drug|reference-anastrozole tablet (Arimidex)|Subjects were allocated to one of two groups randomly and equally with a 21-day washout interval between the two periods.All of them were randomized (1:1) to receive anastrozole as a single oral dose of the test drug or a single 1.0-mg oral dose of Arimidex
15801520|NCT04438720|Drug|Extended Release Nifedipine Tablets 30 mg|The subjects randomly received single oral administration of extended release nifedipine tablets 30 mg.
15801521|NCT04438720|Drug|Extended Release Nifedipine Tablets 30 mg (Adalat® GITS)|The subjects randomly received single oral administration of extended release nifedipine tablets 30 mg.
15801522|NCT04438707|Other|Pilates Method combined with Therapeutic exercice.|Children must perform specific exercices in this combined method with the pilates principes (for back) during 50 min (1 day per week) for 4 weeks.
15801523|NCT04438707|Other|Therapeutic exercise|Children must perform specific exercices without the pilates principes (for back) during 50 min (1 day per week) for 4 weeks.
15801524|NCT04438694|Biological|Convalescent Plasma|Convalescent Plasma
15801525|NCT04438694|Drug|Standard of Care|Standard of Care drugs administered as per Cairo University ICU protocol
15801526|NCT04438668|Device|Centaflow and Standard Care|The intervention is screening methods
15801527|NCT04438668|Diagnostic Test|Standard Care|The intervention is screening methods
15801528|NCT04438655|Drug|Oral antibiotic drugs|"Oral antibiotic drugs:
~- Bimixin (Neomicin + Bacitracin tablet) 25000 UI + 2500 UI: h. 8-16-24 the day before surgery if the procedure takes place in the morning; h. 16-24-8 if the procedure takes place in the afternoon."
15801529|NCT04438655|Drug|Parenteral prophylaxis|"Amoxicillin - Clavulanic Acid 2000/200 mg at induction of anesthesia, redosing with prolonged surgery.
~in case of allergy to penicillin: Clindamycin 600 mg + Gentamycin 2 mg/kg."
15801530|NCT04438642|Procedure|shoulder finishline|tooth will be prepared having shoulder finishline.
15801531|NCT04438642|Procedure|butt joint with bevel|tooth will be prepared having butt joint with bevel finishline.
15801532|NCT04438629|Drug|COVID-19 treatment|COVID-19 affected patients treated with hydroxicloroquine or antiviral therapy (lopinavir/ritonavir) as single agents or in combination (hydroxicloroquine plus antiviral therapy) according to clinical features. Other concomitant treatments (i.e. off-label therapy) will be provided at the discretion of clinicians. Supportive therapy, such as antibiotic prophylaxis and anticoagulant treatment, will be provided at the discretion of the clinicians.
15801533|NCT04438616|Procedure|dome magnetic attachment|"All patients will receive complete denture before implant installation .
~The CBCT examination should be take
~patients received infiltration local anesthesia
~A crestal incision is made using No. 15 c blade .
~Full sequential drilling under copious saline irrigation will be made . insertion of two implant by the contra angle handpiece with special adaptor
~We connect magnetic attachment(dome) on complete denture by pick up procedure at day of implant installation.
~Implant stability will be measured using smart peg /osstell at the day of implant installation and after 2,4,8,12 weeks.
~Patient satisfaction measure"
15801534|NCT04438616|Procedure|flat magnetic attachment|"All patients will receive complete denture before implant installation .
~The CBCT examination should be take
~patients received infiltration local anesthesia.
~A crestal incision is made using No. 15 c blade
~Full sequential drilling under copious saline irrigation will be made as indicated by the company guide lines. insertion of two implant by the contra angle handpiece with special adaptor
~We connect magnetic attachment(flat) on complete denture by pick up procedure at day of implant installation.
~Implant stability will be measured using smart peg /osstell at the day of implant installation and after 2,4,8,12 weeks.
~Patient satisfaction measure in 2 weak and after 12 weak by Denture satisfaction questionnaire"
15801535|NCT04438603|Drug|Intervention for incipient patients at low risk of disease progression|Conservative treatment, if necessary use ACEI/ARB and titrated to the maximum tolerated dose, with a BP-lowering goal of < 130/80 mm Hg
15801536|NCT04438603|Drug|Intervention for patients at high risk of disease progression|"BP-lowering goal of < 125/75 mm Hg and treat with steroids or steroids combined with immunosuppressants based on optimal supportive therapy:
~If GFR>60 ml/min/1.73m^2, oral prednisone 0.6-0.8 mg/kg/day ( (maximum dose 48 mg/day) for 2 months, followed by a monthly dose reduction of 8 mg for 24 weeks.
~If GFR is 30-60 ml/min/1.73m^2, intravenous cyclophosphamide (CTX) 750 mg per month per m^2 for 6 months, along with oral prednisone (at the same dose as 1); if intravenous administration is unacceptable, then the above regimen was replaced with oral mycophenolate mofetil 500 mg bid for 24 weeks."
15801537|NCT04438590|Dietary Supplement|Kelulut Honey|The Substance being tested to be used as an alternative
15801538|NCT04438590|Dietary Supplement|Carborie|The commercially available substance
15801539|NCT04438577|Drug|Lidocaine mucilage-ICG|Lidocaine mucilage-ICG as an agent for intraoperative tumor delineation
15801540|NCT04438564|Other|Cases for patients diagnosed with breast cancer, colonrectal cancer, ovarian cancer and endometrial cancer|Diagnosis and acceptance of breast cancer, colon rectal cancer, ovarian cancer, and endometrial cancer by the clinical Western medicine team.
15801541|NCT04438551|Behavioral|Standard dietary counseling|Subjects will be given a low sodium diet handout with counseling, complete a validated questionnaire on low sodium foods, and complete a 24-hr urine collection.
15801542|NCT04438551|Behavioral|Mobile app|Subjects will be given a low sodium diet handout with counseling, complete a validated questionnaire on low sodium foods, and complete a 24-hr urine collection. Subjects will be given a mobile app to build grocery lists where the sodium level will be recorded and tracked in the app.
15801543|NCT04438525|Diagnostic Test|sting challenge|At the Moment, sting challenges are the only reliable method to identify patients who are not protected by insect venom immunotherapy.
15801572|NCT04438317|Procedure|Pleural drainage procedure with Seldinger procedure|Pleural drainage using Seldinger technique.
15801544|NCT04438525|Other|blood donation|To perform BAT Inhibition Tests, blood samples of patients with confirmed vespid venom allergy, who have not undergone venom immunotherapy, are necessary.
15801545|NCT04438512|Drug|MDMA|Administration of 80 or 120 mg MDMA in combination with psychotherapy and a supplemental dose offered 1.5/2 hrs later of 40 or 60 mg MDMA respectively
15801546|NCT04438512|Behavioral|Psychotherapy|Standardized non-directive psychotherapy performed by therapist team
15801547|NCT04438499|Device|eSense 7fr Single Sensor Bladder Catheter|Urinary and abdominal catheters inserted in to the body to measure pressure for urodynamics.
15801548|NCT04438486|Behavioral|Group A|specific dietary advice for Hyperuricemia
15801549|NCT04438486|Dietary Supplement|Group B|Barely Green（three times a day, 5g(10 tablets)） dietary advice for Hyperuricemia as Group A
15801550|NCT04438473|Dietary Supplement|pectin-supplemented enteral nutrition feeding|sequential supplementation with combination of 90ml pectin and 500ml enteral nutrition formula for 7 days
15801551|NCT04438473|Other|enteral nutrition feeding|standard formula enteral nutrition feeding without pectin for 7 days
15801552|NCT04438460|Biological|Blood test|"For patient group, blood tests will be performed at day 1-2, day 3-5 and day 60.
~For control group, blood test will be performed the day of elective surgery."
15801553|NCT04438447|Dietary Supplement|parenteral feeding|A 3-bag compartment peripheral parenteral solution (mOsm < 800) containing carbohydrate, lipids and proteins will be infused to deliver 20/25 total Kcal/kg for a total of 5 days after the operation
15801554|NCT04438434|Drug|Filming Formulation of Hydrogen Peroxide and Hyaluronic Acid|"The enrolled subjects will be examined and treated by specialized medical personnel.
~The extraction will be carried out by an experienced operator and will follow the standard guidelines for the extraction of impacted teeth. Once the tooth has been removed, a suture with detached stitches using silk thread 3/0 will be applied.
~From a pharmacological point of view, the patient will be prescribed antibiotic therapy (Amoxicillin 1g) to be administered twice daily for seven days, analgesic/anti-inflammatory therapy with NSAIDs (e.g. Synflex 550 mg/Brufen 800 mg) are to be used for a maximum of twice daily.
~The treatment to be evaluated involves mouth rinsing with 10 ml of BMG0703 three times daily, after meals and after normal oral hygiene procedures, for one week (date of the follow-up visit).
~Patients with allergic reactions or hypersensitivity to the product will be advised to discontinue its use, and seek medical advice."
15801555|NCT04438434|Drug|Chlorhexidine mouthwash|"The enrolled subjects will be examined and treated by specialized medical personnel.
~The extraction will be carried out by an experienced operator and will follow the standard guidelines for the extraction of impacted teeth. Once the tooth has been removed, a suture with detached stitches using silk thread 3/0 will be applied.
~From a pharmacological point of view, the patient will be prescribed antibiotic therapy (Amoxicillin 1g) to be administered twice daily for seven days, analgesic/anti-inflammatory therapy with NSAIDs (e.g. Synflex 550 mg/Brufen 800 mg) are to be used for a maximum of twice daily.
~Subjects in this group are to use Chlorhexidine 0.2% mouthwash as an active comparator; 10 ml three times daily, after meals and after normal oral hygiene procedures, for one week (date of the follow-up visit).
~Patients with allergic reactions or hypersensitivity to Chlorhexidine will be advised to discontinue its use, and seek medical advice."
15801556|NCT04438434|Other|Placebo product|"The enrolled subjects will be examined and treated by specialized medical personnel.
~The extraction will be carried out by an experienced operator and will follow the standard guidelines for the extraction of impacted teeth. Once the tooth has been removed, a suture with detached stitches using silk thread 3/0 will be applied.
~From a pharmacological point of view, the patient will be prescribed antibiotic therapy (Amoxicillin 1g) to be administered twice daily for seven days, analgesic/anti-inflammatory therapy with NSAIDs (e.g. Synflex 550 mg/Brufen 800 mg) are to be used for a maximum of twice daily.
~Subjects in this group are to use a placebo product, and will be instructed to use 10 ml for mouth rinsing three times daily, after meals and after normal oral hygiene procedures, for one week (date of the follow-up visit).
~Patients with allergic reactions or hypersensitivity to the product will be advised to discontinue its use, and seek medical advice."
15801557|NCT04438421|Drug|Filming mouthwash formulation, enriched with Hydrogen Peroxide and Hyaluronic Acid|Subjects will then be given the test product, BMG0703, to be used twice a day after meals and after normal oral hygiene procedures. Next, the subjects will be re-evaluated after 3 days and after one month.
15801558|NCT04438421|Drug|Chlorhexidine mouthwash|Subjects will then be given Chlorhexidine 0.2%mouthwash, as an active comparator, to be used twice a day after meals and after normal oral hygiene procedures. Next, the subjects will be re-evaluated after 3 days and after one month.
15801559|NCT04438421|Drug|Placebo|Subjects will then be given a placebo product to be used twice a day after meals and after normal oral hygiene procedures. Next, the subjects will be re-evaluated after 3 days and after one month.
15801560|NCT04438408|Other|questionaires|patients will answer to questionnaires on the quality of life and the control of the asthmatic disease as well as the therapeutic observance.
15801561|NCT04438395|Device|Cardiac ablation via catheter|Cardiac ablation with a catheter to treat atrial flutter and/or atrial fibrillation
15801562|NCT04438382|Biological|Infliximab|Given IV
15801563|NCT04438382|Biological|Intravenous Immunoglobulin Therapy|Given IV
15801564|NCT04438382|Drug|Prednisone|Given IV or PO
15801565|NCT04438382|Other|Quality-of-Life Assessment|Ancillary studies
15801566|NCT04438382|Other|Questionnaire Administration|Ancillary studies
15801567|NCT04438369|Procedure|Erector Spinae Plane Block|Cathether based Erector Spinae Plane Block for postoperative pain management.
15801568|NCT04438356|Combination Product|M-Health|The study was randomized (wait-list-control), and it was estimated that 80 subjects were randomly assigned to the immediate treatment group and the wait-list-control group. The two groups were tested for baseline before intervention in the mHealth. After the first questionnaire evaluation, the experimental group was involved in the mHealth for three months, and after three months, the experimental group and the waiting intervention control group were post-tested. To assess the effectiveness of the two groups before and after the mHealth . Control group that waits for intervention in the fourth month from the beginning of the fourth month to the end of the sixth month.
15801569|NCT04438343|Other|Impairment-specific and augmented intervention|Balance and lower extremities strength training
15801570|NCT04438343|Other|Conventional physical therapy|Trunk and upper extremity training
15801571|NCT04438330|Other|Nickel sulfate hexahydrate|Patch test
15801573|NCT04438317|Procedure|Pleural drainage procedure with surgical-like technique|Pleural drainage using Surgical-like technique.
15801574|NCT04438304|Drug|64Cu-SARTATE|64Cu-SARTATE will be administered at a fixed administration dose, single bolus intravenous injection, peptide mass not exceeding 20µg.
15801575|NCT04438291|Other|MDL-SHPVP|A 2-hour education session with multicomponent interventions including education sessions with small group dialogues with a registered nurse and trained healthcare and lay volunteers and educational computer games
15801576|NCT04438291|Other|30-minute educational video|A 30-minute education video (DVD) on HPV, cervical cancer and the HPV vaccine that is designed to enhance HPV vaccine acceptance
15801577|NCT04438265|Drug|levobupivacaine|local anesthetic
15801578|NCT04438265|Device|ultrasound device|scream
15801579|NCT04438252|Diagnostic Test|ICDAS II|Index for caries detection
15801580|NCT04438252|Device|CariScan Pro|Device for early caries detection
15801581|NCT04438252|Radiation|Digital Radiograpgy|Device for digital x-ray imaging
15801582|NCT04438239|Other|none, this study is observational|none, this study is observational
15801583|NCT04438226|Procedure|Surgical approach|The surgical approach of hemiarthroplasty after femoral neck fracture
15801584|NCT04438213|Drug|Ertugliflozin|Participants will be randomized to six weeks of treatment with either ertugliflozin, metolazone, or a placebo
15801585|NCT04438213|Drug|Metolazone|Participants will be randomized to six weeks of treatment with either ertugliflozin, metolazone, or a placebo
15801586|NCT04438213|Drug|Placebo|Participants will be randomized to six weeks of treatment with either ertugliflozin, metolazone, or a placebo
15801587|NCT04438187|Other|antimicrobial initiation|antimicrobial initiation based on protocol assignment.
15801588|NCT04438174|Drug|Processed Amniotic Fluid|Injection of 1 ml of processed amniotic fluid per 5 cm2 of wound area
15801589|NCT04438174|Other|Standard of Care Wound Treatment Regimen|ointment-based dressing and non-ointment-based dressings
15801590|NCT04438161|Behavioral|PERCCS: Personalized Education Regarding Clinical and Community Supports|A brief follow-up to the screening provided to 50% of the consented families (randomly assigned) that links their specific familial risks to community interventions.
15801591|NCT04438135|Other|Repeated open application test|parallel application of two different types of lotion with and without aluminium.
15801592|NCT04438122|Other|Cabernet Sauvignon|Cabernet Sauvignon is a red wine from a greek company which contains 13.5% alcohol vol.
15801593|NCT04438122|Other|Tsipouro|Tsipouro is a greek spirit which contains 38% alcohol vol
15801594|NCT04438096|Drug|100 mg|One 100 mg pill and two placebo pills (QD) will be orally administered for 12 weeks
15801595|NCT04438096|Drug|200 mg|Two 100 mg pills and one placebo pill (QD) will be orally administered for 12 weeks
15801596|NCT04438096|Drug|300 mg|Three 100 mg pills (QD) will be orally administered for 12 weeks
15801597|NCT04438096|Drug|Placebo|Three placebo pills (QD) will be orally administered for 12 weeks
15801598|NCT04438083|Biological|CTX130|CTX130 CD70-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components.
15801599|NCT04438070|Diagnostic Test|COVID-19 Swab|Nasal, Oral-Nasal combined or Nasopharyngeal swab
15801600|NCT04438057|Biological|CCP|Randomized open label study to receive 2:1 CCP to standard of care
15801601|NCT04438044|Drug|ICP-022|ICP-022 The drug product is a white, round, uncoated tablet
15801602|NCT04438031|Behavioral|Navigation Intervention|This program recruits mothers in OB/GYN (prenatal) offices, provides up to three Navigation visits, establishes connections between the family and primary health care or other community providers, and then follows up one month later to confirm these referrals. Navigators will assess and support family needs across multiple developmentally-appropriate domains at each age. Prenatally, the domains include support for (1) health and access to healthcare, (2) adjustments to pregnancy, (3) household and material needs, and (4) family safety. At 12, 24, and 36 months, the domains include support for (1) child basic needs, (2) parenting and child behavior, (3) child health and development, and (4) parent health and well-being.
15801603|NCT04438031|Behavioral|Control Intervention|Brief information will be provided about child development.
15801604|NCT04438005|Drug|ICP-022|ICP-022 is a white, round, uncoated tablet, 50 mg. It is administered orally at the dose of 150 mg/day from day 1 to day 28 of each cycle for up to a total of 6 cycles or until progression.
15801605|NCT04437992|Genetic|NIPT|The test, which requires two 10 ml tubes of blood, will be performed simultaneously with the chemical biomarkers of the combined test at 10-12 weeks of gestation
15801606|NCT04437966|Behavioral|Enhanced Chronic Disease Self-management program|CDSMP workshops will last for approximately 2.5 hours and occur weekly for six weeks. Sessions will focus on appropriate diet for persons with hypertension and to facilitate weight loss; managing medications, adherence to medical clinic appointments; physical activity and stress management. Participants make weekly action plans, share experiences, and help each other solve problems they encounter in creating and carrying out their self-management program. Participants will also be given pill boxes and will be prompted by social media messages to make and keep clinic appointments as well as maintain a healthy lifestyle.
15801607|NCT04437953|Drug|Avatrombopag|"Patients will receive an initial dose of Avatrombopag 60 mg on Day 1. Starting on Day 2, the dose will be Avatrombopag 20 mg daily. Once a patient has reached a platelet target of > 100,000/mcL patients can initiate systemic cancer therapy. Avatrombopag will be continued as maintenance (subscript m) and titrated weekly with a goal to maintain a platelet count of ≥ 100,000/mcL during administration of systemic cancer therapy. Duration of maintenance therapy will be at least 12 weeks (indicated by Week 1m, Week 2m, … 12m) starting from time of platelet correction and resumption of systemic cancer therapy. End of Treatment (EOT) is up to 15 weeks on study Week 12m."
15801608|NCT04437940|Diagnostic Test|Vaginal fluid Covid-19 PCR test|Vaginal fluid samples are tested for Covid-19
15801609|NCT04437914|Diagnostic Test|Electrocardiogram diagnosis|Electrocardiographic diagnosis will be made in a double-blind manner by two specialists in cardiology and cardiac arrhythmias and the results will be compared between the groups studied.
15801610|NCT04437888|Drug|Ketamine|Ketamine versus saline placebo will be compared in order to evaluate the effects of Ketamine on patients that are pain catastrophizers
15801611|NCT04437875|Biological|Gam-COVID-Vac Lyo|adenoviral-based vaccine against SARS-CoV-2
15801612|NCT04437862|Device|Q Revascularization System|Q Revascularization System for mechanical thrombectomy
15801613|NCT04437849|Device|Home Telemonitoring System|Home Telemonitoring System (HTS) The HTS consists of an App that daily collects measurements of weight, blood pressure, heart rate and symptoms (checklist of symptoms questions). The HTS processes the data and generates and sends an alert to the physicians if a risk situation occurs (measurements are outside of normal ranges). The App has also an educational functionality that allows learning about lifestyle, self-care and healthy habits for HF patients. For this purpose, the application: a) has a section that answers frequent questions, b) has a question and answer game about HF, and c) sends educational messages to the patients every day.
15801614|NCT04437836|Drug|Evaluation of high dose rifampicin in children|Evaluation of severity of adverse event from grade 1 to 5
15801615|NCT04437823|Biological|Intravenous Infusions of Stem Cells|Cultured stem cells will be injected at days 1, 3 and 5 intravenously. While patients will be monitored and evaluated for various hematological and organ functions at baseline (day 0) and days 1, 3, 5, 7, 14, 21 and 30
15801616|NCT04437810|Biological|Albumin|- Patients in the Albumin Arm will receive Human Albumin 20% 1.5g/kg body weight (Maximum 100g) within 6 hours from the time of diagnosis over a period of 12 hours, followed by 1g/kg bodyweight (Maximum 100g) over a period of 12 hours after 48 hours of diagnosis.(D3)
15801617|NCT04437810|Other|Standard Medical Treatment|standard medical therapy
15801618|NCT04437797|Procedure|Surgical Extrusion|The next step will be atraumatic extraction which will be initiated by using straight periotome until it is sufficiently luxated and gently pulled out to the amount of sufficient ferrule effect without encroaching the biological width. 90- or 180-degrees rotation of the tooth will be done if needed. The tooth will be supported from palatal side, etching will be done using 37% phosphoric acid, rinsing, drying, bonding agent and then application of 3M Filtek flowable composite on rounded 16mm stainless steel wire for splinting in the middle of the tooth without extension of flowable composite neither to the mesial nor to the distal. This procedure should be followed by occlusal adjustment if needed. Splint will be removed after 2 weeks.
15801619|NCT04437797|Procedure|Immediate Implant Placement|The patient is anaesthetized. Atraumatic extraction of the badly broken-down teeth will be performed using peroiotome. Luxation should be done mesiodistally and not buccolingually, 11 to avoid damaging the buccal plate. After tooth removal, a curette is used to confirm that the location of the buccal plate is intact. Standard drilling procedures are performed according to the manufacturer's instructions. Then the implant is placed in the prepared site. Temporization should be done using composite 3M Filtek Z250 XT material. Finally, a porcelain fused to zirconia crown will be performed. Jumping gap occurring subsequent to atraumatic extraction and immediate implant placement more than 2 mm will be grafted using Xenograft.
15801620|NCT04437784|Procedure|Laparoscopic Trans-Abdominal Pre-Peritoneal|Laparoscopic trans-abdominal pre-peritoneal repair using 2 separate meshes fixed by endoscopic tackers
15801621|NCT04437784|Procedure|Open pre-peritoneal repair|Open pre-peritoneal single mesh repair with suture fixation
15801622|NCT04437784|Procedure|Bilateral Lichtenstein repair|Bilateral standard Lichtenstein repair using 2 separate meshes with suture fixation
15801623|NCT04437771|Other|Safety and efficacy assessments|Long term disease and gene therapy specific safety evaluations and efficacy assessments
15801624|NCT04437758|Dietary Supplement|Collagen and Vitamin C powder mix nutritional intervention|20 g collagen + 50 mg vitamin C daily, 60 min prior to exercise
15801625|NCT04437758|Other|Maltodextrin placebo powder|20 g maltodextrin placebo daily, 60 min prior to exercise
15801626|NCT04437758|Other|Maximum power training exercise|Explosive/power-based exercise training program 3 times/week at home consisting of drop jumps, box jumps, weighted jump squats loaded in a progressive manner weekly for 3 weeks. At baseline and at the end of each of the 3 weeks, measures of explosive performance are assessed in the lab (maximal isometric squat, counter-movement jump and squat jump)
15801627|NCT04437745|Device|YVOIRE Y-Solution 720|Hyaluronic acid dermal filler
15801628|NCT04437732|Device|Apioc-P and Apioc-PT Contact Lens Design|Novel soft contact lens design
15801629|NCT04437719|Other|Obvio-19 app|"As part of this research, the patient must complete questionnaires daily on the Obvio-19 application, one of 5 minutes.
~Evaluation of the proportion of patients with COVID-19 infection's symptoms known to be associated with COVID-19 diagnosis (fever, cough, loss of taste and smell, sore throat, muscle pain, diarrhea, fatigue, difficulty eating and drinking and shortness of breath) followed during a period of 6 months.
~To assess the prevalence and course of symptoms of COVID-19 infection of patients followed during a period of 6 months.
~To establish the correlation of the COVID-19 infection with the biological and clinical data of patients from the Oncology cohort of the Groupe hospitalier Paris Saint-Joseph in Paris followed during a period of 6 months."
15801630|NCT04437693|Drug|Hydroxychloroquine|The treatment group that will receive Hydroxychloroquine (HCQ) 400mg twice a day on day 1 followed by 400 mg weekly for 7 weeks
15801631|NCT04437680|Device|Votiva device|A retrospective chart review of the medical records
15801632|NCT04437667|Behavioral|Tumaini Mobile Phone Game|Tumaini is a scenario-based role-playing game application. Participants will be instructed to engage in a minimum of 10 hours of gameplay over the holiday period each year. The game will automatically collect for analysis data related to participants' in-game behavior, e.g. time spent playing, scores on knowledge-based mini-games, choices made in the narrative game, components to which the player was exposed. The game is designed to: educate players about sexual health and HIV/AIDS; build risk-reduction skills and related self-efficacy for prevention of HIV/STIs and unintended pregnancy; challenge HIV stigma; and promote parent-child dialogue.
15801633|NCT04437667|Behavioral|Control Mobile Phone Game|Independent gameplay of control game. Total respondent burden: participants will be invited to engage in at least 10 hours of gameplay during each long school holiday (November-December).
15801634|NCT04437654|Drug|Anticoagulation group(Apixaban group)|Apixaban 5mg twice daily (2.5mg twice daily if meets dose-reduction criteria) for 2 years
15801635|NCT04437641|Other|Tobacco questionnaire|"A questionnaire on smoking habits was given to all parents of children being followed in consultation for cystic fibrosis or type 1 diabetes, or whose child was hospitalized for the first time for bronchiolitis.
~Provision of minimal advice (oral and a leaflet from the anti-smoking centre) to parents who smoke by the paediatrician following the child.
~For parents who smoke, evaluation at 3 months of the impact of this minimal advice by another questionnaire during the usual follow-up of the patient at 3 months or by telephone contact."
15801636|NCT04437602|Diagnostic Test|Contrast Enhanced Mammography (CEM)|Additional CEM in preoperative staging
15801637|NCT04437563|Behavioral|HERMES|Via an app, the caregiver answers 14 questions about his/her need for (more) information. The caregiver presents his/her answers (i.e., need for information) to the health care professionals (HCPs), and the HCPs provide the caregiver with the lacking information.
15801638|NCT04437550|Other|Exercise|high intensity exercise = 15 x 60 s sprints at 85% velocity of VO2max (vVO2max) with 60 s walking at 20% vVO2max or moderate intensity exercise = walking at 60% vVO2max
15801639|NCT04437537|Device|PHOENIX Wound Matrix|PHOENIX Wound Matrix will be applied to each subject's DFU following debridement.
15801640|NCT04437524|Other|therapeutic exercises|Treatment that will continue 3 days a week for 6 weeks in female patients with fibromyalgia.
15801643|NCT04437498|Device|sham stimulation|non invasive vagal nerve stimulation
15801644|NCT04437498|Device|nVNS|active vns stimulation
15801645|NCT04437485|Behavioral|Good Days Ahead (GDA)|GDA (Empower Interactive) is an empirically supported, HIPAA compliant, computerized CBT for depression appropriate for primary care patients and people with little computer experience. GDA uses an interactive, multimedia format to deliver 9 45-minute sessions, the structure and content of which mirror face-to-face CBT. General topics include identifying and modifying automatic thoughts, using behavioral activation and other behavioral methods, identifying and modifying schemas, using effective coping strategies, and employing other core CBT methods. GDA is empirically supported - it is acceptable to patients, achieves superior depression outcomes to waitlist comparators, and yields equivalent (noninferior) depression outcomes to standard face-to-face CBT. To minimize time/transportation barriers, GDA sessions occur at the PI's lab or a location with internet access selected by the patient (patient's, family member's, or friend's home).
15801646|NCT04437485|Behavioral|Problem Solving Treatment in Primary Care (PST-PC)|PST-PC is an established, manualized, empirically supported CBT developed for primary care. During the 6-10 30-minute sessions, patients are taught skills for solving problems contributing to depression. We will deliver PST-PC by phone, which has been found to be feasible and efficacious.
15801647|NCT04437485|Drug|Antidepressant Medications|We first considered all FDA-approved antidepressants and excluded those with weight gain effects (tricyclics, paroxetine, mirtazapine) and those rarely used in primary care (MAOIs). Then, we used existing evidence to inform the structure. We made bupropion (an aminoketone) and fluoxetine (an SSRI) our first-line and second-line antidepressants, as meta-analyses indicate that their use is associated with weight loss. We made other SSRIs (escitalopram, sertraline) and SNRIs (desvenlafaxine, duloxetine, venlafaxine) our third-line antidepressants, given their negligible effects on weight. Our team will make recommendations to the patient's PCP, who will write prescriptions. Our team and the PCP will then collaboratively manage pharmacotherapy.
15801648|NCT04437485|Other|Active Control|(1) The graduate research assistant (RA) will have a 50-minute call with AC patients to review depression materials. The RA will provide a list of Eskenazi Health mental health services and will encourage patients to follow-up with their PCP. We will then send an electronic health record message to the PCP encouraging them to address their patient's depression, note that there are no care restrictions, and provide the same list of services. (2) The RA will call AC patients every 4 weeks to assess depressive symptoms and will notify clinical staff to encourage additional care when indicated. (3) AC patients will receive current primary care for depression. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists.
15801649|NCT04437472|Other|CareSignal|The CareSignal software will be programmed to automatically ask a subset of the NCI-PRO-CTCAE questions using SMS depending on patient group as designated by the treating physician: (1) thoracic radiation with chemotherapy, (2) thoracic radiation alone, (3) extremity/body wall sarcoma, and (4) other.
15801650|NCT04437459|Other|High-fat shake|Participant consumes a high-fat test shake. Blood is drawn before and 4 hours after this shake to measure triglycerides.
15801651|NCT04437459|Other|Pure glucose solution|Participant consumes 75 grams of pure glucose. Blood is drawn before and 2 hours after this drink to measure glucose.
15801652|NCT04437446|Diagnostic Test|Case Group|The additional examination corresponds to an OCTA which is a non-invasive examination, without potential risks, without radiation, using infrared light.
15801653|NCT04437446|Diagnostic Test|Control Group|"The additional examinations correspond to:
~OCTA which is a non-invasive examination, without potential risks, without radiation, using infrared light.
~OCT: non-invasive examination, without potential risks, without radiation, using infrared light. The patient must sit in front of a screen and a contact is taken without contact in about ten seconds.
~Visual field"
15801654|NCT04437433|Drug|Atogepant 60 mg|Tablets containing 60 mg atogepant
15801655|NCT04437420|Drug|injection of BEP 800|injection of BEP 800
15801656|NCT04437420|Other|Control|no injection of BEP 800
15801657|NCT04437407|Device|PB2-1 prototype|PB2-1 prototype is a belt-like wearable device similar to the original PrenaBelt designed for pregnant women that permits supine positioning of the pelvis but, when in this position, provides subtle pressure points to the user's body and thereby activates the body's natural mechanism to reposition itself to relieve discomfort. It is expected to significantly decrease the amount of time a pregnant woman's pelvis is in the supine position overnight while promoting comfortable sleep.
15801658|NCT04437407|Device|PB2-2 prototype|PB2-2 prototype is a belt-like wearable device designed for pregnant women. When placed on the woman's back, this device prevents the pelvis from achieving a supine orientation by maintaining at least fifteen degrees of right or left lateral pelvic tilt. It is expected to significantly decrease the amount of time a pregnant woman's pelvis is in the supine position overnight while promoting comfortable sleep.
15801659|NCT04437407|Device|PB2-3 prototype|PB2-3 prototype is a belt-like wearable device designed for pregnant women. When placed on the woman's back, this device prevents the pelvis from achieving a supine orientation by maintaining at least fifteen degrees of right or left lateral pelvic tilt. It is expected to significantly decrease the amount of time a pregnant woman's pelvis is in the supine position overnight while promoting comfortable sleep.
15801707|NCT04437108|Procedure|Li-SWT (combined approach)|The patient will receive 3000 shocks; 1500 shocks through suprapubic approach (500 shocks per site) and another 1500 shocks through perineal approach (500 shocks per site) with energy flux density of 0.12 mJ/mm² and frequency of 4 Hz.
15801660|NCT04437407|Device|PB2-4 prototype|PB2-4 prototype is a belt-like wearable device designed for pregnant women that prevents the user from achieving a supine position as the device allows right and left lateral pelvic tilt but prevents the user's pelvis from settling supine due to virtue of its design. It is expected to significantly decrease the amount of time a pregnant woman's pelvis is in the supine position overnight while promoting comfortable sleep.
15801661|NCT04437407|Device|PB2-5 prototype|PB2-5 prototype is a belt-like wearable device designed for pregnant women that does not provide positional therapy. It can be worn anytime as a maternity support belt.
15801662|NCT04437407|Device|Ajuvia-Active|Ajuvia Sleep Monitor senses the user's body position and can be used in passive or active mode with or without the PB2 prototypes. In the active mode, it alerts the woman when her pelvis is in the supine position through a gentle vibratory alarm.
15801663|NCT04437407|Device|Ajuvia-Passive|Ajuvia Sleep Monitor senses the user's body position and can be used in passive or active mode with or without the PB2 prototypes. In the passive mode, it measures and records the position of the pelvis but does not alert the woman.
15801664|NCT04437394|Diagnostic Test|flexible endoscopic evaluation of swallowing|The patients were assessment with flexible endoscopic swallowing evaluation was performed with colored pudding.
15801665|NCT04437394|Diagnostic Test|The analysis of voice|Voice recordings were taken from the patients to evaluate the voice disturbance and acoustic evaluation was taken with PRAAT program.
15801666|NCT04437368|Drug|GT005; Low Dose|The study will test two doses of GT005: Low Dose and High Dose.
15801667|NCT04437368|Drug|GT005; High Dose|The study will test two doses of GT005: Low Dose and High Dose.
15801668|NCT04437355|Diagnostic Test|Specific provocation test|To compare the results the investigators invite a healthy control group matching in age and gender with the intervention cohort. The control group is informed about the study and asked to participate in the outpatient clinic. In case of informed consent, the participants are invited to the study site. The participants undergo the same provocation test of the ankle, and are asked to complete the specific provocation test. In case of substantial underachievement in the provocation test (<60% of maximum) an X-Ray of both ankles in a.p. and lateral projection is performed. The aim is to radiologically analyse the ankles, and to rule out any morphological reasons for the above mentioned underperformance.
15801669|NCT04437342|Other|PHQ-9 (Patient Health Questionnaire) Depression Scale|9 question questionnaire for assessment of depression
15801670|NCT04437342|Other|GAD-7 (General Anxiety Disorder) scale|7 question questionnaire for assessment of General Anxiety Disorder
15801671|NCT04437342|Other|38 questions questionnaire|38 questions questionnaire
15801672|NCT04437342|Other|EPDS (Edinburgh Postnatal Depression Scale)|10 questions scale for detection of postpartum depression
15801673|NCT04437329|Drug|Docetaxel, nedaplatin, fluorouracil|Induction chemotherapy. Docetaxel 60 mg/m2 intravenous day1. Nedaplatin 60 mg/m2 intravenous day1. Fluorouracil 3000 mg/m2 continuous intravenous infusion 120 hours from day1. Every 21 days, 3 cycles.
15801674|NCT04437329|Drug|Docetaxel, cisplatin, fluorouracil|Induction chemotherapy. Docetaxel 60 mg/m2 intravenous day1. Cisplatin 60 mg/m2 intravenous day1. Fluorouracil 3000 mg/m2 continuous intravenous infusion 120 hours from day1. Every 21 days, 3 cycles.
15801675|NCT04437329|Drug|Nedaplatin|Concurrent chemotherapy. Nedaplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.
15801676|NCT04437329|Drug|Cisplatin|Concurrent chemotherapy. Cisplatin 100 mg/m2 intravenous at day1, 22, 43 of radiotherapy.
15801677|NCT04437329|Radiation|Intensity modulated-radiotherapy|Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.33 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor.
15801678|NCT04437316|Device|Use of Low level Laser after wisdom tooth removal|Directly after the wisdom teeth removal of the right/left side, one of the low level laser (therapeutic and non-therapeutic (Placebo)) is used.
15801679|NCT04437303|Drug|Continuation of oral anticoagulants|Oral anticoagulant treatment will not be interrupted before the procedure.
15801680|NCT04437303|Drug|Interruption of oral anticoagulants|"Peri-operative interruption of oral anticoagulants will be according to the Dutch guideline on antithrombotic therapy.
~For direct oral anticoagulant users this will be in general 48 hours before the procedure, except for Dabigatran users with renal insufficiency: with estimated glomerular filtration rate 50-80 mL/min/1.73m^2 72 hours and with estimated glomerular filtration rate 30-50 mL/min/1.73m^2 96 hours before procedure.
~For vitamin K antagonist users this will be 5 days for phenprocoumon and 3 days for acenocoumarol.
~After the procedure oral anticoagulants will be resumed after 24 hours, if deemed safe by the treating physician."
15801681|NCT04437290|Drug|investigational radiotracer [18F]MK6240|Brain PET scan
15801682|NCT04437277|Diagnostic Test|Hepatitis C, serology|Inclusion of patients in conventional hospitalization at Saint Joseph Hospital. Each consenting patient benefits from a screening HCV serology carried out during a biological sample indicated by his state of health. In the case of positive HCV serology, an additional sample will be taken in search of viral replication. All detectable HCV PCR patients will be admitted to hepatology consultation for assessment of liver status including non-invasive methods and possible treatment according to the conditions of the Marketing Authorization and recommendations for routine clinical practice. Data on management (treatment or non-treatment and treatment outcome: prolonged virological response 12 weeks after completion of treatment) will be collected.
15801683|NCT04437264|Dietary Supplement|Intermittent feed participant|Patients will be assigned to receive intermittent enteral feeding protocol. They will receive four equal volume feeds at 8:00, 12:00, 16:00, and 20:00 hours.
15801684|NCT04437264|Dietary Supplement|Continuous feeds participant|Patients will be assigned to receive continuous enteral feeding protocol. Typical goal rates are in the range of 60 to 80 mL per hour for 24 hours per day.
15801685|NCT04437251|Device|Transcranial direct current stimulation (tDCS)|Transcranial direct current stimulation (tDCS) is an non-invasive, low-intensity direct current stimulation. The stimulation intensity is very low (0- 2 mA) to only produce tingling sensation on the scalp. From literature, there were no serious adverse effects reported after 20-minute stimulation. The main temporary side effect is skill irritation, itching sensation at the stimulation site during or after stimulation.
15801708|NCT04437108|Procedure|Sham treatment|The same technique of Li-SWT will be used but the applicator of the shock wave device will be turned off.
15801831|NCT04436120|Procedure|Research blood draws|Blood biospecimens collected following disease progression
15801686|NCT04437238|Other|KeepWell tool|KeepWell is standalone eHealth application aimed at supporting the self-management of older adults with multimorbidity, and it has the following features: (i) lifestyle advice for any combination of the top 10 chronic conditions affecting older adults); (ii) an avatar health coach that walks users through a health prioritization and goal setting exercise; (iii) a health risk questionnaire (HRQ) covering health (chronic diseases), lifestyle (physical activity, diet, smoking, alcohol, caffeine, bladder health), and social and emotional well-being (social frailty, isolation, loneliness) dimensions; (iv) an evidence-based, customized Action plan; (v) an interactive lifestyle tracker; (vi) journaling; (vii) and a health resources library. A health coach avatar leads users through a health priority and goal setting exercise that allows them to create a customized action plan based on guideline recommendations for lifestyle changes.
15801687|NCT04437238|Other|Control - Usual care|Participants allocated to the control condition will receive care as usual.
15801688|NCT04437225|Dietary Supplement|Low oxalate controlled Diet|Participants will consume a diet that is controlled in its contents of protein, carbohydrates, fat, calcium, oxalate, vitamin C and sodium. Participants will be asked not to take any dietary supplements, exercise strenuously, or consume food or drink that is not provided to them.
15801689|NCT04437225|Other|Primed, continuous intravenous infusion of 13C2-Glycolate|Participants will receive a continuous intravenous administration of carbon-13 glycolate, a naturally occurring form of glycolate, over the course of several hours until steady-state is achieved, using an IV catheter.
15801690|NCT04437225|Other|Bolus intravenous infusion of 13C2-Glycolate|Participants will receive a bolus intravenous administration of carbon-13 glycolate, a naturally occurring form of glycolate, using an IV catheter.
15801691|NCT04437225|Other|Oral bolus administration of 13C2-Glycolate|Participants will orally ingest a single dose of carbon-13 glycolate, a naturally occurring form of glycolate.
15801692|NCT04437212|Drug|Toripalimab|Patients received toripalimab 240mg every 3 weeks 1-7 days after neoadjuvant chemoradiotherapy for 2 cycles before operation and 28-42 days after operation for 4 cycles.
15801693|NCT04437199|Drug|Tricaprilin|"Powder formulation will be mixed with 240 mL water and shaken until fully dispersed.
~Each dosing unit of 12.5 g of AC-SD-03 contains 5 g of the active ingredients (tricaprilin)"
15801694|NCT04437199|Drug|Placebo|Powder formulation will be mixed with 240 mL water and shaken until fully dispersed.
15801695|NCT04437186|Behavioral|Recovery program|The researchers designed a recovery group suited to Taiwanese with mental illness, according to content of the Pathways to Recovery (PTR): A Strengths Recovery Self-Help Workbook (Ridgway et al., 2002) and recovery-related literature (Davidson et al., 2005; Ridgway, 2001)
15801696|NCT04437173|Device|Virtual Reality Headset Distraction|Patient wears a virtual reality headset during interventional pain procedure
15801697|NCT04437160|Drug|Epirubicin or Pirarubicin|Epirubicin 80-90mg/m2 IV or Pirarubicin 50mg/m2 IV, q21d*4cycls
15801698|NCT04437160|Drug|Cyclophosphamide|Cyclophosphamide 600mg/m2 IV, q21d*4cycls
15801699|NCT04437147|Dietary Supplement|Placebo|Fibers with vitamins and minerals will be administered for 30 days once a day in sachets
15801700|NCT04437147|Dietary Supplement|3 Billion UFC strains of probiotics|Fibers with vitamins and minerals will be administered for 30 days once a day in sachets with 3 billion CFU strains of probiotics
15801701|NCT04437147|Dietary Supplement|8 Billion UFC strains of probiotics|Fibers with vitamins and minerals will be administered for 30 days once a day in sachets with 8 billion CFU strains of probiotics
15801702|NCT04437134|Other|On-line exercise and education|"Exercise:
~Exercise is performed twice weekly for 6 weeks. Each exercise session lasts approximately 60 min. and consists of three parts; warm-up (10 min.), neuromuscular exercises (40 min.), and cool-down/stretching (10 min.). The neuromuscular exercises include exercises for core stability, postural orientation, function and leg muscle strength. Exercises are performed in 2-3 sets with 10-15 repetitions with three levels of difficulty described. The exercises follow the standardized GLA:D exercise protocol. Patients are instructed in how to use alternative equipment at home for each exercise if necessary prior to the first on-line exercise session.
~Education:
~Patients attend two to three on-line educational sessions at the start of each GLA:D program. The educational sessions focus on disease-management and self-help strategies, including OA disease features and symptoms, treatment options, and exercise and physical activity as treatment."
15801703|NCT04437134|Other|On-site exercise and education|"Exercise:
~Exercise is performed twice weekly for 6 weeks. Each exercise session lasts approximately 60 min. and consists of three parts; warm-up (10 min.), neuromuscular exercises (40 min.), and cool-down/stretching (10 min.). The neuromuscular exercises include exercises for core stability, postural orientation, function and leg muscle strength. Exercises are performed in 2-3 sets with 10-15 repetitions with three levels of difficulty described. The exercises follow the standardized GLA:D exercise protocol. The exercise sessions are delivered at physiotherapy clinics in Denmark.
~Education:
~Patients attend two to three on-site educational sessions at the start of each GLA:D program. The educational sessions focus on disease-management and self-help strategies, The educational sessions focus on disease-management and self-help strategies, including OA disease features and symptoms, treatment options, and exercise and physical activity as treatment."
15801704|NCT04437121|Other|Online Survey about Dietary and Lifestyle Habits|"An online survey was conducted in a random sample of families. Parents self-reported their child's and their own dietary and lifestyle habits, as well as information about their sociodemographic status.
~The survey consisted of 70 questions in 3 sections."
15801705|NCT04437108|Procedure|Li-SWT (suprapubic approach)|The patient will be asked to lie in flat dorsal position. A commercially used gel for sonography will be applied to the suprapubic region. The applicator will be placed on suprapubic region with two fingers apart from the symphysis pubis tilting to 45°. Shock waves will be directed to 3 different sites; the midline (over the bladder dome) and 3 cm right and left to the midline (over bilateral bladder walls). The patient will receive 3000 shocks (1000 shocks per site) with energy flux density of 0.12 mJ/mm² and frequency of 4 Hz.
15801706|NCT04437108|Procedure|Li-SWT (perineal approach)|The patient will be asked to lie in lithotomy position. A commercially used gel for sonography will be applied to the perineum. The applicator will be placed on perineal region. Shock waves will be directed to 3 different sites: the midline and 2 cm right and left to the midline. The patient will receive 3000 shocks (1000 shocks per site) with energy flux density of 0.12 mJ/mm² and frequency of 4 Hz.
15801775|NCT04436614|Dietary Supplement|Dietary Supplement:Aloe Vera (simple)|Dietary Supplement:Aloe Vera (simple)with 1L of Aloe Vera 1 glass bottle per 15 days
15801709|NCT04437108|Drug|Solifenacin|The patients will be treated by antimuscarinics (solifenacin) which are considered as the conventional treatment of storage symptoms after prostatectomy.
15801710|NCT04437095|Other|Psychological Support Based on Positive Suggestion delivered via pre-recorded MP3 message|Daily administration of audiorecording
15801711|NCT04437082|Device|optical coherence tomography|imaging structural and vascular features of the eye
15801712|NCT04437069|Other|Decision Aid|Participants will view a Decision Aid (delivered as an app) that provides them with information regarding congenital heart disease, as described in the literature. The DA is tailored to the specific diagnosis of the fetus/neonate, so that participants are only viewing information about their baby's specific CHD diagnosis (and not other types of CHD). This is shown using videos and diagrams to clearly explain the defect, what their treatment options are (surgical intervention, comfort care, or termination), and personal stories from other parents who have dealt with the same diagnosis before (including both positive and negative outcomes). The DA was developed according to the International Patient Decision Aid Standards (see http://ipdas.ohri.ca/) (IRS# 14-13332).
15801713|NCT04437069|Other|Values Clarification Exercise|The Values Clarification Exercise is a process that aids patients in clarifying their values and goals to improve alignment of their preferences with their chosen treatment. It was developed according to the International Patient Decision Aid Standards. It includes ten values that were chosen based on feedback from the parent investigators and clinicians. The ten values are: 1) discomfort to the child, 2) time in the hospital, 3) risk that the child will have impairments, 4) need to provide home medical care, 5) chronic medical care/decisions, 6) financial issues, 7) life in adulthood, 8) impact on the family, 9) beliefs about doing everything medically possible, & 10) life expectancy. Each value has a sliding scale where the user can compare 2 treatment options at a time. They are asked which described situation feels better for them and their family.
15801714|NCT04437056|Procedure|Cognitive nerve transfers to spastic upper extremity muscles in stroke patients|Based on the fact that upper motor neuron syndrome after stroke is presented with variable clinical features, usually without affecting in the same way the entire upper extremity, we aim to investigate the efficacy of nerve transfers to spastic muscles after stroke using as donor nerves that innervate unaffected ipsilateral volitionally controlled muscles.
15801715|NCT04437043|Other|quality of life questionnaires|pain will be recorded in rest and activity (VAS) and patients will complete the quality of life questionnaires (CCS, BIQ). Also, the intake of analgesic medication will be registered. A clinical examination is conducted to evaluate the occurrence of seroma and to evaluate recurrence, defined as a protrusion of the contents of the abdominal cavity or preperitoneal fat through the defect, which is no longer covered by the mesh.
15801716|NCT04437030|Device|MSOT Acuity Echo device|The MSOT acutiy Echo device can take ultrasound recordings in addition to photoacoustic recordings.
15801717|NCT04437017|Drug|Olanzapine+NK-1 RA+5-HT3 RA|On day 1-4, Olanzapine (5mg) is delivered orally after dinner.
15801718|NCT04437017|Drug|Dexamethasone+NK-1 RA+5-HT3 RA|On first day, dexamethasone (12 mg) is given orally/intravenously within 30 minutes before cisplatin administrated, and on day 2-4, the given dose of dexamethasone is 8 mg.
15801719|NCT04437004|Drug|Fenfluramine|The treatment plan for this Expanded Access Protocol is for patients with Dravet syndrome who do not qualify for participation in one of the ongoing ZX008 (fenfluramine hydrochloride) clinical trials.
15801720|NCT04436991|Diagnostic Test|Blood sampling|"At predefined time points through a venous catheter already in place. Max. volume to be withdrawn: Maximum 4ml/sample. Maximum 10 samples/patient.
~A last blood sample will be taken, if necessary, after the end of antibiotic therapy, between day 7 and day 14. Though blood results preferably will be used from available data from tests already done during standard treatment.
~Samples are collected in lithium-heparin tubes (without gel) and centrifuged immediately (within a maximum of 30 minutes after sampling) at room temperature: 8 minutes at 1885g.
~Plasma is then collected and divided in two separated labelled Eppendorf tubes 1.5 ml and immediately frozen at - 80 °C. If this is not immediately possible, tubes are frozen at - 20 °C and at regular time points transferred to a freezer at - 80 °C (minimum twice a day)."
15801721|NCT04436991|Diagnostic Test|Sputum sample|Bacteriological specimen, such as blood cultures, urine samples, sputum ea., which are usually collected in every patient according to standard care will be retained. If there is bacterial growth, MIC's will be calculated on these strains for study purpose.
15801722|NCT04436991|Diagnostic Test|Hemoculture|Bacteriological specimen, such as blood cultures, urine samples, sputum ea., which are usually collected in every patient according to standard care will be retained. If there is bacterial growth, MIC's will be calculated on these strains for study purpose.
15801723|NCT04436991|Diagnostic Test|Urine sample|Bacteriological specimen, such as blood cultures, urine samples, sputum ea., which are usually collected in every patient according to standard care will be retained. If there is bacterial growth, MIC's will be calculated on these strains for study purpose.
15801724|NCT04436978|Drug|First month DAPT|One month of aspirin + P2Y12 inhibitor followed by 11 months of oral anticoagulants + P2Y12 inhibitor
15801725|NCT04436978|Drug|First month standard therapy|One month of oral anticoagulant + P2Y12 inhibitor + limited duration of aspirin as per international guidelines (during hospitalization or 7 days; up to 30 days for high thrombotic risk patients); followed by 11 months of oral anticoagulants + P2Y12 inhibitor
15801726|NCT04436965|Other|Standardized nutrition therapy|Standardized nutrition therapy with ONS, nasal feeding tube, PEG or parenteral nutrition
15801727|NCT04436965|Drug|Cisplatin|Patients in both arms received concurrent cisplatin chemotherapy:100 mg/m² cisplatin given intravenously every 3 weeks on days 1, 22 concurrently with radiotherapy.
15801728|NCT04436965|Radiation|Intensity Modulated Radiation Therapy|Patients in both arms received Intensity Modulated Radiation Therapy:All target volumes were outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes were defined in accordance with the International Commission on Radiation Units and Measurements Reports 83. The prescribed dose was 70-72 Gy to PTVnx (Planning target volume of the primary tumor), 64-70 Gy to PTVnd (Planning target volume of the cervical lymph node),60- 64Gy to PTV1 (Planning target volume 1), and 54-58 Gy to PTV2 (Planning target volume 2) in 30-32 fractions. The details of dose limits for organs at risk were based on the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225).
15801776|NCT04436614|Dietary Supplement|Dietary Supplement:Mediterranean Diet|Dietary Supplement:Mediterranean dietary protocol Intervention:mediterranean diet
15801729|NCT04436952|Device|H7 coil|The H7 coil arm will receive a medial prefrontal cortex (mPFC) DTMS 5 days a week for 8 consecutive weeks = 40 Sessions 20 Hz at 100% MT, 2 s on 20 s off intertrain interval, 50 trains, 2000 stimuli per session.
15801730|NCT04436952|Device|Cool D-B80|The Cool D-B80 arm will receive dorsomedial prefrontal cortex (DMPFC) rTMS 5 days a week for 8 consecutive weeks = 40 sessions 10 Hz at 120% MT, 5 s on 10 s off intertrain interval, 60 trains, First 3000 pulses to the left DMPFC then 3000 pulses to the right DMPFC. TMS will be done at active state by provocation
15801731|NCT04436952|Behavioral|Exposure Response Prevention (ERP)|The ERP will be conducted for 2 hours on week 1 and week 8 and for 1 hour on Weeks 2 to 7 for a total of 10 hours
15801732|NCT04436939|Device|Dental implant|Following dental implant installation, PEEK or Ti healing abutments were placed according to the split mouth study design.
15801733|NCT04436926|Behavioral|opioid approach bias modification|The investigators will use a training version of the Approach-Avoidance Task (AAT), in which patients are asked to respond to the format of presented pictures, irrespective of the pictures' content. Pushing a presented picture away will decrease picture size, whereas pulling a picture closer will increase size. There are 2 categories of pictures; 20 different opioid and 20 different non-medication alternative pain managing activities. Training effect is achieved by presenting opioid pictures in push format only and non-opioid pictures in pull format only. Two hundred training trials are presented per session.
15801734|NCT04436926|Behavioral|sham training|Sham training is identical to opioid approach bias training, except pictures are presented randomly in both formats.
15801735|NCT04436913|Other|Himalaya complete care toothpaste|Herbal toothpaste as a part of a caries preventive regimen
15801736|NCT04436913|Other|Signal toothpaste|fluoride based toothpaste as a part of a caries preventive regimen
15801737|NCT04436913|Other|Signal toothpaste and fluoride varnish|application of fluoride varnish and using fluoride based toothpaste
15801738|NCT04436900|Procedure|Panretinal Photocoagulation (PRP)|PRP with ARC with a spot number of 1,200 to 1,500 per eye and spot size 500 micron with a duration of 200 ms.
15801739|NCT04436887|Procedure|positioning of polypropylene strips for prophylactic purposes in closing the middle laparotomies to prevent the incisional hernia|Sub-lay mesh supported closure A 4 cm space is created between posterior rectus sheath and rectus muscle, widening 2 cm at each side of midline. Both posterior rectus sheath edges are sutured using a running slowly absorbable suture. Above arcuate line, posterior layer was performed suturing peritoneum and posterior rectus sheath; below arcuate line, posterior layer was performed suturing peritoneum and trasversalis fascia. Anterior layer was performed suturing anterior rectus sheath. A suture length to wound length ratio of 4:1 is recommended. A 4-cm Parietex Progrip Mesh strip was placed between the posterior rectus sheath and rectus muscle with an overlap of at least 2 cm at each side, suture less. In laparotomies >20 cm two stripes of 15 cm each were designed. The midline anterior rectus sheath was closed using a running slowly absorbable suture, covering the mesh. A suture length to wound length ratio of 4:1 is recommended.
15801740|NCT04436874|Device|endoscopy|transplant infusion of feces from healthy donors into affected subjects
15801741|NCT04436848|Other|This is a non-interventional study|This is a non-interventional study
15801742|NCT04436835|Behavioral|Psychotherapy|Undergo ART
15801743|NCT04436835|Other|Questionnaire Administration|Ancillary studies
15801744|NCT04436822|Device|Continuous Glucose Monitoring|CGM and frequent sample testing
15801745|NCT04436809|Procedure|Sentinel Node Biopsy|"Colloidal radiotracer (99Tc) is injected into the breast near the cancer. The radiotracer moves in the lymph ducts to accumulate in the first lymph nodes (almost always in the axilla) to receive lymph from the breast area containing the cancer. Lymphoscintigraphy is used to check for the presence of radioactivity in the axilla. Some hours later, during breast surgery, a radioactivity-detecting probe is used to identify hot lymph nodes (sentinel nodes) and aid their surgical removal from the axilla. These nodes are examined histologically (intraoperatively) for the presence of cancer. If they are disease-free the axilla will be left intact (no further axillary treatment given); if they contain cancer most lymph nodes in the axilla will be removed surgically (axillary dissection)."
15801746|NCT04436809|Procedure|Axillary Dissection|Axillary dissection is the surgical removal of all Berg level I and II lymph nodes present in the axilla. The operation is carried out, at our Institute, during the surgery to treat the cancer in the breast (either breast-conserving surgery - quadrantectomy, or mastectomy).
15801747|NCT04436796|Device|interoperable Artificial Pancreas System (iAPS)|Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS.
15801748|NCT04436796|Other|Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS)|Use of personal pump with study CGM & glucometer at home for 13 weeks.
15801749|NCT04436783|Device|Virtual Reality Epley Maneuver System (VREMS)|The VREMS system includes a smartphone placed inside virtual reality goggles worn by the participant. On the smartphone there is a virtual reality application. When viewed through the VR goggles the participants see a three-dimensional environment. Audio and text cues are presented in a 3D environment to help guide the patient through the Epley maneuver.
15801750|NCT04436783|Other|Instructional Handout (IH)|Patients randomized to the IH group will be given an instructional handout with image and text-based instructions on the steps involved in performing the Epley maneuver. They will then be given the chance to perform the Epley maneuver.
15801751|NCT04436770|Other|Non-immersive virtual reality therapy|"Non-immersive Virtual Reality (VR) therapy exercises, based on assessment, and occupational therapy exercises, for upper extremity or lower extremity.
~For the upper extremity, daily, from 20-40 to minutes of VR therapy plus 20-40 minutes of occupational therapy exercises, according to the patient's capacity of VR training, as entire therapy for upper extremity don't exceed 60 minutes.
~For the lower extremity, from 20-40 to minutes of VR therapy plus 20-40 minutes of occupational therapy exercises, according to the patient's capacity of VR training, as entire therapy for the lower extremity don't exceed 60 minutes.
~The protocol for occupational therapy exercises for the hand included the use of the Canadian plate, thick and thin grip training, lateral and palmar pinch as well as wrist extensor strengthening tasks.
~For the ankle and foot, analytical and dexterity exercises using Mirror therapy and alone were used."
15801777|NCT04436601|Drug|Polyethylene Glycols|Polyethylene glycol will be administered to half of the study patients, and their response recorded and compared with that of the Lactulose arm.
15801832|NCT04436107|Drug|Zanubrutinib|160 mg administered orally twice daily (BID)
15801752|NCT04436770|Other|Standard Physiotherapy|"Standard physiotherapy program, based on assessment, plus occupational therapy exercises, for upper extremity or lower extremity.
~For the upper extremity, daily, 30 minutes of standard physiotherapy plus 30 minutes of occupational therapy exercises.
~For the lower extremity, daily, 30 minutes of standard physiotherapy plus 30 minutes of occupational therapy exercises.
~The protocol for occupational therapy exercises for the hand included the use of the Canadian plate, thick and thin grip training, lateral and palmar pinch as well as wrist extensor strengthening tasks.
~For the ankle and foot, analytical and dexterity exercises were used."
15801753|NCT04436757|Behavioral|IPS program : Self-image and body representation|"The IPS program consists in 13 sessions of 2 hours over a 13-weeks period.
~Sessions content is as follows :
~: Introduction
~: Sensory approach workshop
~: Self presentation and personal hygiene
~: Organisation of well-being, planning and pictograms
~: Becoming aware of my body, my envelope
~: Presentation and self-esteem (photolanguage)
~: Self-presentation in social interactions: Social codes
~: My ideas and desires for change
~: Places of well-being and clothing hygiene
~: Vocational insertion devices
~: Daring change : presence of a Socio-hairdresser
~: The awakening of color : presence of a Socio-aesthetician
~: Development of practice sheets and the network"
15801754|NCT04436757|Behavioral|TAU|The treatment of the group TAU (Treatment As Usual) will consist of the usual care proposed by the health service. No additional session will be proposed.
15801755|NCT04436744|Drug|Giredestrant|During the window-of-opportunity phase (first 2 weeks) giredestrant will be taken orally once per day (QD) as a single agent. During the neoadjuvant treatment phase, giredestrant will be taken orally QD on Days 1-28 of each 28-day cycle for a total of 4 cycles, in combination with palbociclib.
15801756|NCT04436744|Drug|Anastrozole|During the window-of-opportunity phase (first 2 weeks), anastrozole 1 mg will be taken orally QD as a single agent. During the neoadjuvant treatment phase, anastrozole 1 mg will be taken orally QD on Days 1-28 of each 28-day cycle for a total of 4 cycles, in combination with palbociclib.
15801757|NCT04436744|Drug|Palbociclib|During the neoadjuvant treatment phase, palbociclib 125 mg will be taken orally QD on Days 1-21 of a 28-day cycle for a total of 4 cycles.
15801758|NCT04436744|Procedure|Surgery|Surgery must be performed within a maximum of 14 days after the final cycle in the neoadjuvant treatment phase and ideally should occur as soon as possible after the last dose of study treatment.
15801759|NCT04436731|Other|Hypoxia Exposure|Systemic oxygen levels will be titrated by mixing nitrogen with air in a medical gas blender to attain steady arterial oxygen saturations of 80%.
15801760|NCT04436731|Drug|Phenylephrine|Phenylephrine (0.0625 mcg/min/dL tissue) will be locally infused via brachial artery catheter during the final 3 min of normoxia and hypoxia.
15801761|NCT04436731|Drug|Dexmedetomidine|Dexmedetomidine (12.5 ng/min/dL tissue) will be locally infused via brachial artery catheter during the final 3 min of normoxia and hypoxia.
15801762|NCT04436731|Drug|Norepinephrine|Norepinephrine (8 mg/min/dL tissue) will be locally infused via brachial artery catheter during the final 3 min of normoxia and hypoxia.
15801763|NCT04436731|Drug|Phentolamine|Phentolamine will be locally infused via brachial artery catheter for 10 min before baseline measurement (12 mcg/dL/min) and the infusion will continue at a maintenance rate (5 mcg/dL/min) during acute normoxia and hypoxia.
15801764|NCT04436718|Diagnostic Test|Daily pocus exam|Daily evaluation of lung ultrasound for B line artifacts plus IVC assessments
15801765|NCT04436705|Other|Progressive Muscle Relaxation (PMR) technique|The PMR technique utilized in this study was based on the original technique designed by Jacobson (1938) and subsequently modified by Bernstein and Borkovec (1973). The PMR technique involves tensing the individual muscle groups for about 5 seconds for each muscle. Then, allowing them to relax for about 10 seconds, and notice how the muscle feels when it is relaxed in contrast to how it felt when it was tensed. The technique is accompanied by breathing exercises in order to feel the sense of relaxation. In this study, the PMR technique refers to tensing and relaxing the muscles from the forehead to the feet one by one, including the eleven muscle groups (right arm, left arm, forehead, jaw and neck, back and shoulders, stomach, thighs, right calf, left calf, right foot and left foot). The total procedure takes around 20 minutes.
15801766|NCT04436692|Behavioral|Nudging|Use nudging approach by using smaller plates and glasses and increasing the availability of fruits and vegetables
15801767|NCT04436666|Device|motivational video production through virtual reality glasses|Music-funded, park, nature and seaside walks, submarine, museum, with virtual reality glasses (Bobo VR Z4 Binocular Glasses and 5.7 inch 1440x2560 pixel display resolution, China) for 10 minutes to diabetic patients before blood glucose measurement and insulin injection The videos that the patient wants to watch will be watched from videos such as his trip Studies have indicated that these videos are relaxing environments, and motion videos should not be watched to reduce nausea and vomiting.
15801768|NCT04436666|Other|Ice Application|Before the blood glucose measurement and insulin injection, patients with diabetes will be given ice for 5 minutes. It is planned to apply ice cubes in liquid-proof ice bags.
15801769|NCT04436653|Device|Tricuspid Valve Replacement System|To eliminate the tricuspid regurgitation through orthotopically replacing tricuspid valve with LuX-Valve system.
15801770|NCT04436640|Drug|Bimekizumab|Subjects will receive bimekizumab at prespecified time-points.
15801771|NCT04436627|Device|Amadeo-assisted training-1|Participants will receive 12-15 intervention sessions for about 3 consecutive weeks in a clinical setting (1 hour per session, 4-5 sessions per week). For each intervention session, participants will first receive 20 minutes active assistive training mode, followed by 20 minutes RT functional games (grasp and release) and 20 minutes RT finger coordination training.
15801772|NCT04436627|Device|Amadeo-assisted training-2|Participants will receive 12-15 intervention sessions for about 3 consecutive weeks in a clinical setting (1 hour per session, 4-5 sessions per week). For each intervention session, participants will first receive 10 minutes continuous passive motion mode followed by 20 minutes active assistive training mode, and 30 minutes RT functional games (grasp and release).
15801773|NCT04436627|Device|Amadeo-assisted training-3|Participants will receive 12-15 intervention sessions for about 3 consecutive weeks in a clinical setting (1 hour per session, 4-5 sessions per week). For each intervention session, participants will first receive 20 minutes continuous passive motion mode followed by 20 minutes active assistive training mode. After 40 minutes of RT, 20 minutes functional tasks without robot.
15801774|NCT04436614|Dietary Supplement|Dietary Supplement:Aloe Vera with Crocus (saffron)|Dietary Supplement:Aloe Vera with Crocus (saffron) with 1L of Aloe Vera with Crocus (saffron) 1 glass bottle per 15 days
15801778|NCT04436601|Drug|Lactulose|Lactulose (standard of care) will be administered to half of the study patients and their response recorded.
15801779|NCT04436588|Genetic|Epigenetic signatures|Epigenetic signatures (Dr Sadikovic' lab, London, Ontario, Canada)
15801780|NCT04436575|Device|Point-of-care ultrasound|Point-of-care ultrasound prognostic performance : echocardiography mainly
15801781|NCT04436562|Drug|[14C]-Poziotinib|Single oral administration of 8 mg (as the hydrocholoride salt) of [14C]-poziotinib
15801782|NCT04436549|Procedure|Stab Avulsion of varicose veins|Stab avulsion is a technique to remove varicose veins. In this procedure, several tiny cuts (incisions) are made in the skin through which the varicosed vein is removed. Removed varicose veins will be collected and analyzed.
15801783|NCT04436549|Diagnostic Test|Histopathologic evaluation of varicose veins|Sample obtained from varicose veins of lower limbs of patients will be collected and immediately fixed in formalin. The tissue fragments will be taken from varicose veins. Subsequently the tissue will be embedded in paraffin and 3-to-4 mm thick sections will be prepared by a microtome. The tissue sections will be processed for histological and immunohistochemical studies of VEGF, MM9, PGP 9.5 AND FRIBRONECTIN. For antibodies the EnVision staining system (Dako EnVision™) will be used. For the analysis of the positive structures detected by immunohistochemistry, a semiquantitative evaluation method will be used.
15801784|NCT04436536|Other|Treadmill walking training with random speed changes|Participants were asked to walk in different gait speed randomly on the treadmill (80%, 90%, 100%, 110% and 120% of preferred speed). The training speed would be changed in every 15 seconds in 2-minutes-section. 2 minutes/ section, 10 sections/ day, 3 days/ week, 2 weeks. 1 minute rest time would be held between sections.
15801785|NCT04436536|Other|Treadmill walking training with blocked speed changes|Participants were asked to walk in same gait speed on the treadmill per day (80%, 90%, 100%, 110% and 120% of preferred speed, respectively). 2 minutes/ section, 10 sections/ day, 3 days/ week, 2 weeks. 1 minute rest time would be held between sections.
15801786|NCT04436523|Device|Blood flow restriction (Delfi Personalized Tourniquet System)|The Delfi Personalized Tourniquet System will be utilized to apply the blood flow restriction protocol.
15801787|NCT04436523|Other|Standard rehabilitation|Post-operative physical therapy as guided by a standardized protocol for patients undergoing meniscus repair.
15801788|NCT04436510|Drug|Matching Placebo|"Drug: Matching Placebo
~Administration: Oral
~Dose: two tablets twice daily"
15801789|NCT04436510|Drug|Verdiperstat|"Drug: Verdiperstat
~Administration: Oral
~Dose: 600mg twice daily"
15801790|NCT04436497|Drug|Zilucoplan|"Drug: Zilucoplan Administration: Subcutaneous injection
~Dosage: Minimum of .0.22 mg/kg daily to a maximum dose of 0.42 mg/kg daily, dependent on weight"
15801791|NCT04436497|Drug|Matching Placebo|"Drug: Matching Placebo
~Administration: Subcutaneous injection
~Dosage: Daily subcutaneous injection"
15801792|NCT04436484|Diagnostic Test|Peripheral blood sampling|Non-interventional study
15801793|NCT04436471|Biological|Gam-COVID-Vac|adenoviral-based vaccine against SARS-CoV-2
15801794|NCT04436458|Drug|Niclosamide Oral Tablet|Continued SOC therapy together with niclosamide TID for 14 days
15801795|NCT04436458|Drug|Placebo|Continued SOC therapy together with placebo tablets matching niclosamide for 14 days
15801796|NCT04436445|Combination Product|dry cupping|represents the location and clinical importance of each acupoint. First, the position of the patient will be supine lying for SP6, SP9, KI6, GB34 and CV6 acupoints and it will be prone lying for B23 acupoint. Second, the skin will be cleaned by alcohol then cups will be placed on the acupoints. Dry cupping for SP6, SP9, KI6 and GB34 acupoints will be applied using small cups while dry cupping for CV6 and B23 will be applied using large cups. Third, a negative pressure will be applied with a manual handle. Finally, the cups will be removed after 5 to 15 minutes by pressing one side of the skin with a finger to release the vacuum slowly.
15801797|NCT04436445|Other|Life style modification|Life style modification
15801798|NCT04436419|Dietary Supplement|Alpha lipoic acid (plus full hospitalization)|"Women are included in an 8-weeks randomized double-blind against placebo supplementation study with ALA (eight per group) according to the following criteria:
~Inclusion criteria: BMI> 30; aged between 18 and 75 years. Non-inclusion criteria: HLA-DRB1*04-03/06 polymorphisms; recent hospitalization (<1 month); food supplement based on antioxidant; medicated in fibrate / telmisartan (modulator of PPARs); patients presenting an acute inflammatory state.
~Exclusion criteria: Pregnant and/or lactating women; not affiliated with social security; not mutual health insurance; person deprived of liberty; participation in clinical research in the last 6 months.
~Patients included in this clinical trial benefited from a complete hospitalization including dietary monitoring with a personalized food plan and an adapted physical activity program. α-LA (2x300mg/day of R-ALA) was administered double-blinded in the form of 2 capsules apart from meals."
15801799|NCT04436419|Dietary Supplement|Placebo (full hospitalization: dietary monitoring with an adapted physical activity program)|Women are included in an 8-weeks randomized in placebo group. Patients included in this clinical trial benefited from a complete hospitalization including dietary monitoring with a personalized food plan and an adapted physical activity program. Placebo (2x300mg/day) was administered double-blinded in the form of 2 capsules apart from meals.
15801800|NCT04436406|Diagnostic Test|[99mTc]-NM01 SPECT|Technetium labelled anti-PD-L1 single-domain antibody (NM01) single-photon emission computed tomography (SPECT)
15801801|NCT04436393|Diagnostic Test|Guardant360 test|tumor cfDNA testing
15801802|NCT04436354|Procedure|vaginoscopic office hysteroscopy|comparison of procedural time and pain scores of patients in different gynecologycal positions
15801803|NCT04436328|Procedure|Surgical treatment|Surgical treatment of native vertebral osteomyelitis consisting of debridement, spinal decompression and instrumentation using hardware. Additional standard antimicrobial therapy, according to the pathogen and its antimicrobial susceptibility (intravenous route during first 2 weeks, followed by oral route for additional 4 weeks).
15801804|NCT04436328|Other|Antimicrobial treatment|No surgical intervention, antimicrobial therapy only, bed rest or temporary external immobilization of affected spinal segment with orthopedic orthesis. Antimicrobial therapy will be administrated according to the pathogen type and antimicrobial susceptibility, with initial intravenous administration for 2 weeks, followed by oral antibiotics for 4 weeks to complete 6 weeks of total therapy.
15801805|NCT04436315|Device|Motor-cognitive training device|Motor-cognitive training device
15801806|NCT04436315|Other|Active control condition|Physical activity program
15801807|NCT04436302|Device|Exergame device|motor-cognitive training
15801808|NCT04436289|Behavioral|Home Link|In the Home Link intervention, a team will conduct home visits to (1) provide a structured clinical assessment; (2) reconcile medications, (3) provide psychosocial support through patient-centered counseling, and (4) assess home needs (food security). These visits will start one week after discharge and be repeated every two weeks until the participant is stabilized and ready to initiate lower intensity clinic-based services or three months have elapsed.
15801809|NCT04436276|Biological|Ad26.COV2.S|Participants will receive intramuscular (IM) injection of Ad26.COV2.S.
15801810|NCT04436276|Biological|Placebo|Participants will receive Placebo.
15801811|NCT04436263|Behavioral|Supplement|A sufficient quantity of the winery by-products will be extracted on an industrial scale and capsules will be produced, each one containing 110mg of phenolic compounds (gallic acid equivalents).Volunteers will consume 6 capsules along with a standardized meal (1131 kcal, 19.7% carbohydrates, 11.2% protein, 66.7% fat) and blood will be drown before the meal consumption and at specific time points for the next 6h
15801812|NCT04436263|Behavioral|Placebo|A look-alike placebo containing maltodextrin will be prepared.Volunteers will consume 6 capsules along with a standardized meal (1131 kcal, 19.7% carbohydrates, 11.2% protein, 66.7% fat) and blood will be drown before the meal consumption and at specific time points for the next 6h
15801813|NCT04436250|Drug|Active comparator|The active comparator is composed of clonidine 1 microg/kg combined with magnesium sulfate 40 mg/kg diluted in 45 ml of sodium chloride
15801814|NCT04436250|Drug|S-Ketamine Low dose|The arm 1 is composed of esketamine 0.2 mg/kg and clonidine 1 microg/kg combined with magnesium sulfate 40 mg/kg diluted in 45 ml of sodium chloride.
15801815|NCT04436250|Drug|S-Ketamine High dose|The arm 2 is composed of esketamine 0.4 mg/kg and clonidine 1 microg/kg combined with magnesium sulfate 40 mg/kg diluted in 45 ml of sodium chloride.
15801816|NCT04436237|Other|Virtual reality foot placement training|The training is conducted in sitting and standing, and involves both the affected and unaffected foot placement. In the total immersive virtual environment, a target will be presented and the participants are required to move one foot to the target. The location of the moving foot is not seen by the participant in this training.
15801817|NCT04436224|Drug|Hydromorphone|Intravenous analgesia using hydromorphone in ICU patients with non-mechanical ventilation(NS 40ML+ hydromorphone 10mg ，IV-Pump)
15801818|NCT04436224|Drug|Fentanyl|Intravenous analgesia using fentanyl in ICU patients with non-mechanical ventilation(NS 40ML+ fentanyl 0.5mg, IV-Pump)
15801819|NCT04436224|Drug|Butorphanol|Intravenous analgesia using butorphanol in ICU patients with non-mechanical ventilation(NS 40ML+ butorphanol 10mg，IV-Pump)
15801820|NCT04436211|Procedure|Total Knee Arthroplasty|The common procedure of Total Knee Arthroplasty is investigated in order to compare the techniques of implantation (kinematic vs mechanical alignment)
15801821|NCT04436198|Device|MORCHER® EYEJET® CTR Types 14, 14A, and 14C|"Intervention. Toric IOL + CTR. Whether the subject receives 14, 14A, or 14C is an either or scenario depending on the eye's axial length and is a single intervention:
~Axial length > 28.0 mm: CTR model 14A Axial length 24.0-28.0 mm: CTR model 14C Axial length < 24.0 mm: CTR model 14
~Lens Selection: The patients will undergo standard of care preoperative measurements and planning. The surgeon will evaluate preoperative measurements and use lens calculations, as well as a discussion with the patient, to identify whether a toric lens will be used and to determine the IOL power, cylinder, and target axis (standard of care). Preoperative measurements will be taken using IOL-Master 700, with the addition of the Pentacam and automatic keratometry as needed (standard of care). The toric lens used will be the TECNIS IOL. It will be used on label (standard of care)."
15801822|NCT04436198|Device|Toric IOL Only|"Control. Toric IOL only. Standard of care cataract surgery without placement of a capsular tension ring.
~Lens Selection: The patients will undergo standard of care preoperative measurements and planning. The surgeon will evaluate preoperative measurements and use lens calculations, as well as a discussion with the patient, to identify whether a toric lens will be used and to determine the IOL power, cylinder, and target axis (standard of care). Preoperative measurements will be taken using IOL-Master 700, with the addition of the Pentacam and automatic keratometry as needed (standard of care). The toric lens used will be the TECNIS IOL. It will be used on label (standard of care)."
15801823|NCT04436185|Behavioral|Comparisons of procedural pain|This randomized experimental study with placebo and control groups
15801824|NCT04436172|Procedure|spinal anesthesia|The spinal anesthesia was given by a trained anesthetist in an equipped room, after all aseptic measures. A 20 gauge intravenous cannula was inserted for maintaining a peripheral line and 0.9% normal saline was used for loading the patient. The pulse and blood pressure were monitored non-invasively. The median approach was utilized and intrathecal space was accessed via 25 gauge Quiincke bevel(Becton Dickinson/Pakistan ) through L4-L5. A block was performed by using 5 mg hyperbaric bupivacaine (Abocain 0.5%/Abbot) after ensuring swirling. Block height was monitored via pinprick test after every three minutes, for 20 minutes until there was no progression. The couple was left alone. The couples received prior training and were explained precautions.
15801825|NCT04436159|Procedure|Addition of 360 fundoplication after crural closure|A total fundoplication was constructed in which the right and left part of the wrap was brought together in front of, and slightly to the right of the esophagus, and sutured with three interrupted stitches of 2-0 unabsorbable sutures from the GEJ and cranially to attain a length between the top and bottom sutures of at the most 2 cm. At least one wrap suture included the esophageal muscle-wall.
15801826|NCT04436159|Procedure|Addition of 180 posterior fundoplication after crural closure|"The wrap was pulled dorsally around the distal part of the esophagus and GEJ, which was encircled approximately 180-200 degrees. First, the wrap was anchored with Gore-tex sutures, dorsally to the left crus with 3 sutures and then to the right crus with another 3 sutures.
~Finally, the wrap was completed with 3-4 sutures, between the edges of the wrap and the right and left side of the esophageal wall, respectively."
15801827|NCT04436146|Other|laryngeal manual therapies|The laryngeal manual therapy incorporates massaging the laryngeal muscles thus reducing excessive tension in the laryngeal and perilaryngeal musculature in patients with globus .
15801828|NCT04436133|Biological|Biological/Vaccine: 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha)|Inject vaccine produced by ChinaVaccineSerum, containing HPV antigen protein, 270μg/1ml per bottle
15801829|NCT04436133|Biological|9-valent HPV vaccine（Gardasil 9）|Inject Gardasil 9 , containing HPV antigen protein, 270μg/0.5ml per bottle
15801830|NCT04436120|Procedure|De novo tumor tissue biopsy|De novo tissue biopsy performed following disease progression
15801833|NCT04436107|Drug|Lenalidomide|Administered as specified in the treatment arm
15801834|NCT04436094|Procedure|Orthodontic extrusion|"An orthodontic attachment will be bonded to the core of the experimental tooth. Orthodontic brackets American Orthodontics Roth prescription. 0.022 slot will be bonded to the adjacent teeth. A passive rectangular stainless steel wire (0.016X0.022) will be inserted in the adjacent teeth with a step down and a coil at the site of the experimental tooth.
~Orthodontic extrusion will start using a light overlay wire of 0.012 NiTi and then continued by elastic chains/ threads extending between the attachment on the tooth and the stabilizing wire. The patient is followed up for appliance activation every 3-4 weeks and extrusion is performed until an adequate ferrule effect of 2 mm is present all around the tooth circumference (in addition to the biologic width). So the extrusion is completed when the tooth is 4-4.5 mm from the alveolar bone crest as judged by periapical radiographs."
15801835|NCT04436094|Procedure|Immediate implant placement|The patient is anaesthetized. Atraumatic extraction of the badly broken down teeth will be performed using peroiotome. Luxation should be done mesiodistally and not buccolingually, to avoid damaging the buccal plate. After tooth removal, a curette is used to confirm that the location of the buccal plate is intact. Standard drilling procedures are performed according to the manufacturer's instructions. Then the implant is placed in the prepared site. Temporization should be done using composite 3M Filtek Z250 XT material. Finally, a porcelain fused to zirconia crown will be performed.
15801836|NCT04436081|Drug|THC-free CBD Oil|Hemp-based CBD oil Gelcaps
15801837|NCT04436081|Drug|Placebo|Placebo Gelcaps
15801838|NCT04436068|Device|Hyperfine MRI scan|Participants receive a Hyperfine low field strength brain MRI scan in addition to a regularly scheduled standard clinical CT or MRI scan.
15801839|NCT04436055|Other|No Intervention will be used|Since this is an observational study, there are no interventions.
15801840|NCT04436042|Device|MyHand Device|These subjects may be asked to attend 1-10 sessions (approximately 90 mins) to trial a variety of device controls and/or components.
15801841|NCT04436029|Biological|Descartes 11|Car T-cells
15801842|NCT04436016|Drug|Ivabradine|Ivabradine pills will be crushed and encapsulated for adequate dosing (0, 2.5mg, 5mg or 7.5 mg) and blinding.
15801843|NCT04436016|Drug|Placebo|Mannitol will be encapsulated for adequate blinding.
15801844|NCT04436003|Behavioral|Muscle and articulation chains GDS method|"A physiotherapy method adapting treatment to patient's terrain, or psychomorphology, using chosen techniques to balance tension between muscle chains, thus optimalizing posture and mouvement."
15801845|NCT04435990|Biological|10,000 MM09|Purified allergenic extract, and adsorbed in aluminum hydroxide and polymerized with glutaraldehyde, mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae) with a concentration of 10,000 UT / mL
15801846|NCT04435990|Biological|30,000 MM09|Purified allergenic extract, and adsorbed in aluminum hydroxide and polymerized with glutaraldehyde, mite mixture (Dermatophagoides pteronyssinus and Dermatophagoides farinae). The concentration is 30,000 UT / mL
15801847|NCT04435990|Biological|Placebo subcutaneous|The same solution and presentation as the active treatment, but without active ingredients.
15801848|NCT04435977|Drug|Cabozantinib 60 MG|"• The assigned dose for study treatment is 60 mg qd. Two dose reductions will be permitted (Table 2):
~60 mg qd to 40 mg qd (level 1)
~40 mg qd to 20 mg qd (level 2)"
15801849|NCT04435964|Drug|Immunotherapy|Patients treated as per clinical prescription with immunocheckpoint inhibitors (ICI) irrespective of treatment schedule, either as single agent or in combination with chemotherapy and/or radiotherapy
15801850|NCT04435951|Other|Evaluation|No attempt was made to the individuals in Group 1 and Group 2. Individuals were only evaluated.
15801851|NCT04435938|Radiation|Stereotactic Body Radiotherapy (SBRT)|45 Gy in 5 fractions delivered once every 3-4 days
15801852|NCT04435925|Drug|Remifentanil|Loading dose: 0.5 mcg/kg Maintenance dose: 1 mcg/kg/minute
15801853|NCT04435925|Drug|Fentanyl|Loading dose: 2 mcg/kg Maintenance dose: 0.4 mcg/kg/30-minutes
15801854|NCT04435912|Drug|Hydrocortisone 200mg IV|single dose pre-treatment given IV given at the time when the patient is attached to the cardiopulmonary bypass machine
15801855|NCT04435899|Other|Physical exercise|Multi-modal exercise protocol
15801856|NCT04435886|Dietary Supplement|Probiotic|Probiotic mixture with maltodextrin as a carrier.
15801857|NCT04435886|Dietary Supplement|Placebo|Placebo comparator with maltodextrin as a carrier.
15801858|NCT04435873|Other|"Survey using Your Home Dialysis Care Experience tool."|Validation of a new survey instrument to capture the experience of care by home dialysis patients.
15801859|NCT04435860|Other|Truncal flexion-extension muscle power|Patient performs a maximum truncal flexion laying supine on the bed with cap of muscle tester placed on sternum,
15801860|NCT04435860|Other|Truncal extension muscle power|Patient performs a maximum truncal extension laying prone on the bed while the cap of manual muscle tester placed on vertebrae at the level of midline between superior angles of scapulae.
15801861|NCT04435860|Other|Cervical flexion muscle power|Patient performs a maximum cervical flexion sitting while the cap of manual muscle tester placed on the middle of the forehead.
15801862|NCT04435860|Other|Cervical extension muscle power|Patient performs a maximum cervical extension sitting while the cap of manual muscle tester placed on protuberantia occipitalis.
15801863|NCT04435860|Other|Cervical lateral flexion muscle powers|Patient performs a maximum cervical lateral flexions on right and left sitting while the cap of manual muscle tester placed on relevant pterion.
15801864|NCT04435860|Other|Shoulder flexion muscle power|Patient performs a maximum shoulder flexion of the dominant side on upright while the cap of manual muscle tester placed on midpoint of the line between anterior aspect of acromion and anterior elbow.
15801865|NCT04435860|Other|Shoulder extension muscle power|Patient performs a maximum shoulder flexion of the dominant side on upright while the cap of manual muscle tester placed on midpoint of the line between posterior aspect of acromion and posterior elbow.
15801866|NCT04435860|Other|Shoulder internal rotation muscle power|Patient performs a maximum shoulder internal rotation of the dominant side on upright while the cap of manual muscle tester placed on midpoint of the line between anterior elbow and wrist.
15801867|NCT04435860|Other|Shoulder external rotation muscle power|Patient performs a maximum shoulder external rotation of the dominant side on upright while the cap of manual muscle tester placed on midpoint of the line between posterior elbow and wrist.
15801868|NCT04435860|Other|Shoulder abduction muscle power|Patient performs a maximum shoulder abduction of the dominant side on upright while the cap of manual muscle tester placed on midpoint of the line lateral aspect of acromion and lateral epicondyle.
15801869|NCT04435860|Other|Hip flexion muscle power|Patient performs a maximum hip flexion laying supine on the bed while the cap of manual muscle tester placed on middle of the anterior thigh.
15801870|NCT04435860|Other|Hip extension muscle power|Patient performs a maximum hip extension laying prone on the bed while the cap of manual muscle tester placed on middle of the posterior thigh.
15801871|NCT04435860|Other|Hip abduction muscle power|Patient performs a maximum hip abduction laying supine on the bed while the cap of manual muscle tester placed on middle of the lateral thigh.
15801872|NCT04435860|Other|Hip internal rotation muscle power|Patient performs a maximum hip internal rotation laying supine on the bed while the cap of manual muscle tester placed on the midline between lateral condyle of femur and lateral malleolus.
15801873|NCT04435860|Other|Hip external rotation muscle power|Patient performs a maximum hip external rotation laying supine on the bed while the cap of manual muscle tester placed on the midline between medial condyle of femur and medial malleolus.
15801874|NCT04435860|Other|Bath Ankylosing Spondylitis Functional Index (BASFI)|"This questionnaire evaluates the functionality in patients with AS. The ten questions that comprise the BASFI were chosen with input from patients with AS. The first 8 questions evaluate activities related to functional anatomical limitations due to the course of this inflammatory disease. The final 2 questions evaluate the patients' ability to cope with everyday life. A visual analogue scale (with 0 being easy and 10 impossible) is used to answer the questions on the test. The final score varies between 0 and 10."
15801875|NCT04435860|Other|Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|This questionnaire evaluates the disease activity level in patients with AS. The BASDAI consists of a 0 - 10 scale measuring discomfort, pain, and fatigue (0 being no problem and 10 being the worst problem) in response to six questions asked of the patient pertaining to the five major symptoms of AS. The final score varies between 0 and 10.
15801876|NCT04435860|Other|The Health assessment questionnaire (HAQ)|The Health assessment questionnaire (HAQ) is a questionnaire for the assessment of disability in an individual. The patients report the amount of difficulty they have in performing eight daily living activities. Each question asks on a scale ranging from 0 to 3 if the categories can be performed without any difficulty (scale 0) up to cannot be done at all (scale 3). The final score varies between 0 and 3.
15801877|NCT04435860|Other|Bath Ankylosing Spondylitis Metrology Index (BASMI)|Bath Ankylosing Spondylitis Metrology Index, a combined index to assess the spinal mobility. It evaluates the patients regarding cervical rotation, tragus-to-wall distance, lumbar flexion, lumbar lateral flexion and intermalleolar distance. The total score varies between 5 to 15 in patients with ankylosing spondylitis
15801878|NCT04435847|Biological|HST 001|Participants will receive intradermal injections at 3 timepoints only: week 0, week 6 and week 12. At each of these 3 interventional visits they will receive 0.1 mL X 20 injections spaced approximately 0.8 - 1.2 cm apart from one another of active treatment (HST 001).
15801879|NCT04435847|Other|Phosphate Buffered Saline|Participants will receive intradermal injections at 3 timepoints only: week 0, week 6 and week 12. At each of these 3 interventional visits they will receive 0.1 mL X 20 injections spaced approximately 0.8 - 1.2 cm apart from one another of placebo control (Phosphate Buffered Saline).
15801881|NCT04435821|Drug|[18F]FTC-146|Participants will be injected with 0.08 mCi/kg [18F]FTC-146. A whole-body PET/MRI scan will be performed after injection.
15801882|NCT04435808|Drug|Hydroxychloroquine|"Hydroxychloroquine- oral administration: Duration: up to 90 days or until meeting study termination criteria. Subjects will recieve 600 mg loading dose, followed by 200 mg daily (tablets).
~Loading dose: 600 mg once for the first day Maintenance dose: 200 mg, daily"
15801883|NCT04435795|Drug|Normal Saline intranasal and placebo inhaler|Normal Saline intranasal BID and Placebo 3 puff MDI inhaled BID
15801884|NCT04435795|Drug|Ciclesonide|Ciclesonide 600mcg BID inhaled with aero chamber
15801885|NCT04435795|Drug|Ciclesonide nasal|intranasal ciclesonide 200 mcg DIE
15801887|NCT04435756|Other|Biomarker Analysis|Correlative study
15801888|NCT04435756|Procedure|Blood Product Collection|Undergo collection of blood
15801889|NCT04435743|Drug|Lenalidomide|"Lenalidomide is given as any following dosage:
~25mg, PO QD, Day 1-10 in every 21 days for 6 cycles;
~15mg, PO QD, Day 1-14 in every 21 days for 6 cycles;
~25mg, PO QD, Day 1-10 in every 21 days for 1 year;
~25mg, PO QD, Day 1-21 in every 28 days for 1 year;
~25mg, PO QD, Day 1-10 in every 28 days for 12 cycles;
~20mg, PO QD, Day 1-21 in every 28 days for 12 cycles."
15801890|NCT04435730|Diagnostic Test|serum level of Mac 2 binding protein|"Serum levels of Mac 2 binding protein will be measured for all the study subjects using Enzyme-Linked Immuno sorbent Assay (ELISA).
~2 ml of venous blood will be collected from patients and controls under complete aseptic conditions in a plain tube. Sample will be allowed to clot for 15-30 min at room temperature and then centrifuged at 2500 rpm for 10-15 min. Serum will be separated and stored at -20 C or lower till time of assessment."
15801891|NCT04435730|Device|musculoskeletal ultrasound|MSUS examination will be performed for patients of all groups and control group.Gray scale (GSUS) and power Doppler (PDUS) at joints levels and entheses will be performed with the same transducer of My Lab Seven Crystalline esaote machine.
15801892|NCT04435717|Drug|Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1|Tocilizumab 20 MG/ML Intravenous (one dose)
15801893|NCT04435717|Drug|Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]_#1 (2 doses)|Tocilizumab 20 MG/ML Intravenous ( two doses)
15801894|NCT04435704|Drug|Oxytocin|Intravenous Oxytocin
15801895|NCT04435691|Drug|Azacitidine|Given SC or IV
15801896|NCT04435691|Biological|Magrolimab|Given IV
15801897|NCT04435691|Drug|Venetoclax|Given PO
15802635|NCT04429347|Drug|Placebo|Friday night: 1 capsule, Saturday night: 2 capsule, Sunday night: choice of 1 or 2 capsules
15801898|NCT04435678|Diagnostic Test|ALEX² test using the MAX 45k automated laboratory system|"The ALEX² test system is a quantitative in vitro diagnostic (IVD) test for the measurement of allergen specific IgE (sIgE) and a semi-quantitative in vitro diagnostic test for the measurement of total IgE (tIgE) in human serum or plasma (exception EDTA plasma).
~The MAX 45k analyzer is intended for an automated in-vitro diagnostics use for quantitative determination of allergen specific Immunoglobulin E and semi-quantitative determination of total IgE. The MAX 45k is suitable for human serum or plasma (Heparin, Citrat, but no EDTA). MAX 45k is intended to be used only in conjunction with RAPTOR SERVER analysis software and ALEX based technology arrays."
15801899|NCT04435665|Drug|NFX-179 Gel|gel for topical administration
15801900|NCT04435665|Drug|Vehicle Gel|vehicle gel for topical administration
15801901|NCT04435652|Drug|QL1604|3mg/kg, D1,8,15,Q4w, IV infusion
15801902|NCT04435652|Drug|Nab-paclitaxel|100mg/m2, D1,8,15,Q4w, IV infusion
15801903|NCT04435652|Drug|Paclitaxel|80mg/m2, D1,8,15,Q4w, IV infusion
15801904|NCT04435639|Other|Manual lymph drainage.|"Manual Lymphatic drainage:
~Patients will receive manual lymphatic drainage by massage for 40 minutes for 5 treatments over a 15 day period."
15801905|NCT04435639|Procedure|Coban compression bandage..|Coban compression bandaging: Patients will be wrapped in Coban compression bandaging which stays on until the next treatment. Patients will wear standard compression sleeves during the six month maintenance phase.
15801906|NCT04435639|Device|Adjustable Compression Sleeve|Patients wear an adjustable compression sleeve (Juzo varocare adjustable compression system) between treatments. They will be shown how to put it on and how to tighten the sleeve when needed. Patients will also wear the adjustable compression sleeve in alternation with a standard compression sleeve over a six month maintenance phase.
15801909|NCT04435613|Other|protective mechanical ventilation strategies|1. Reduce tidal volume from 7 ml/kg to 5 ml/kg. 2 Set end-inspiratory pausa. 3 respiratory rate reduction until 20% of the basal condition
15801912|NCT04435587|Drug|Ivermectin Pill|3 days of once daily oral ivermectin 600mcg/kg/d
15801913|NCT04435587|Drug|Combined ART/hydroxychloroquine|"Day 1 hydroxychloroquine 400mg bid, Day2-5 hydroxychloroquine 200mg bid
~Darunavir/ritonavir (400/100mg) q 12 hours for 5 days"
15801914|NCT04435574|Drug|Lactoferrin|Bovine Lactoferrin 100mg sachets.
15801915|NCT04435574|Drug|Ferrous Sulfate|6mg/kg of ferrous sulfate.
15801916|NCT04435561|Other|Standard physiotherapy rehabilitation and dry needling|The dry needling group receives 6 sessions of dry needling in the spastic muscles of the upper and lower hemiparetic limbs.
15801917|NCT04435561|Other|Standard physiotherapy rehabilitation|This group receives their traditional intervention, without dry needling.
15801918|NCT04435535|Procedure|PEP|Positive expiratory pressure 10 cmH2O 15 min
15801919|NCT04435522|Drug|Maraviroc|Maraviroc will be administered for seven days. Biomarkers of disease will be checked at time of enrollment, during and at the conclusion of therapy. The cytokine panel will consist of CCL5, IL-6, and Chitinase 3-like 1(Chi3l1).
15801920|NCT04435509|Dietary Supplement|1000+ Greek Mountain Tea|Dietary Supplement: Greek Mountain Tea dietary intake of the content of 12 grams (4 grams 3 times per day ) 50 grams per month
15801921|NCT04435509|Other|Mediterranean Diet|a Mediterranean dietary protocol
15801922|NCT04435496|Device|GYN-CS|placement of the GYN-CS device
15801923|NCT04435483|Drug|Acalabrutinib Treatment A|Participants will receive a single dose of 100-mg acalabrutinib suspension via NG administration, under fasted conditions. A single dose of 20 mg rabeprazole will be administered with 240 mL water, 2 hours prior to administration of acalabrutinib suspension. Treatment with rabeprazole 20 mg twice daily (with meals) will be started 3 days prior to the receiving the first dose of acalabrutinib suspension.
15801924|NCT04435483|Drug|Acalabrutinib Treatment B|Participants will receive a single dose of 100-mg acalabrutinib suspension via NG administration, under fasted conditions.
15801925|NCT04435483|Drug|Acalabrutinib Treatment C|Participants will receive a single dose of 100-mg acalabrutinib capsule, under fasted conditions. The acalabrutinib capsule will be administered with 240 mL of water.
15801926|NCT04435444|Other|Masterful supportive care|"Three study questionnaires:
~Functional Assessment of Cancer Therapy-General* (FACT-G), Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being* (FACIT-Sp) Memorial Symptom Assessment Scale Short Form* (MSAS-SF)"
15801927|NCT04435444|Other|Attention control supportive care|"Three study questionnaires:
~Functional Assessment of Cancer Therapy-General* (FACT-G), Functional Assessment of Chronic Illness Therapy- Spiritual Well-Being* (FACIT-Sp) Memorial Symptom Assessment Scale Short Form* (MSAS-SF)"
15801928|NCT04435431|Drug|Mesdopetam|Oral use
15801929|NCT04435431|Drug|Placebo|Oral use
15801930|NCT04435418|Drug|Apixaban|The decision to treat with apixaban and the timing of initiation will be at the attending physicians' discretion, independent of enrolment in EASSE.
15801931|NCT04435405|Other|Observational|video footage analysis of group and individual behavioral processes.
15801932|NCT04435392|Drug|Jaktinib Hydrochloride Cream|Subjects in each group were scheduled to give the drug for 8 weeks.
15801933|NCT04435392|Drug|Placebo|Placebo
15801936|NCT04435366|Drug|Zimura|Zimura Intravitreal Injection
15801937|NCT04435366|Drug|Sham|Sham Injection
15801938|NCT04435353|Device|VibroLUNG|Lungs intensive therapy
15802813|NCT04428060|Other|Standard CPR|Resuscitation based on current guidelines
15801939|NCT04435340|Diagnostic Test|Selective Sonography of the ventral abdominal hernia level|The primary outcome of the study is measured by an radiologist experienced in abdominal ultrasound with a linear ultrasound transducer (ML 6-15 Hz). In case of aggravated examination circumstances a different ultrasound transducer is used (linear 9 L or convex C 1-6 Hz)
15801940|NCT04435314|Drug|Nitazoxanide|Subjects will receive nitazonanide 600 mg TID for 7 days
15801941|NCT04435314|Drug|Placebo|Subjects will receive placebo TID for 7 days.
15801942|NCT04435301|Device|DC-Stimulator, NeuroConn, Germany|Neurostimulation device
15801943|NCT04435288|Drug|week 24|"At the week 24 timepoint, there are 3 possible scenario's:
~In patients that do not reach a state of clinical remission at week 24, blinded study medication will be interrupted and all patients will start open-label SC golimumab for an additional 36 weeks (up to max. week 60).
~In patients that achieve sustained clinical remission at week 24, defined as absence of clinical arthritis, enthesitis and dactylitis at both week 12 and week 24, all study medication will be discontinued and prospective follow-up will be planned in SPARTACUS Phase B.
~In patients that reach a state of clinical remission at week 24, but that did not yet reach this status at week 12, blinded study medication will be continued without any change in the treatment schedule for another 12 weeks."
15801944|NCT04435288|Drug|week 36|"At week 36, patients that have continued the blinded study medication, will be re-assessed regarding sustained clinical remission (at week 24 and 36): if yes, all study medication will again be discontinued and prospective follow-up will be planned in SPARTACUS Phase B. If no, these patients will start open-label SC golimumab for an additional 24 weeks (up to max. week 60).
~If patients were in the open-label golimumab treatment arm, effectiveness of the treatment will be assessed by using the PASSI-question. Inadequate responders will be discontinued from the study and will be treated with standard-of-care medication at the discretion of their treating rheumatologist, whereas patients with an acceptable improvement in signs and symptoms will continue with the same (open-label) medication schedule."
15801945|NCT04435288|Drug|Week 48|"At week 48, all patients still remaining in SPARTACUS Phase A will have been treated with open-label golimumab (for a minimum of 12 weeks, but potentially up to 48 weeks). In patients reaching at this timepoint sustained clinical remission (at week 36 and 48), golimumab will be discontinued and prospective follow-up will be planned in SPARTACUS Phase B. For the other patients there are 3 possible scenarios:
~If clinical remission for the first time at week 48, continuation without any change in the treatment schedule for another 12 weeks.
~If an inadequate response (based on the PASSI-question), discontinuation from the study and standard-of-care medication
~If an acceptable improvement (but no clinical remission), continuation open-label golimumab for an additional 12 weeks, with open-label methotrexate (unless contra-indicated) to fulfil Belgian reimbursement criteria for TNFi."
15801946|NCT04435288|Drug|Week 60|At week 60 (final study visit of SPARTACUS Phase A), patients reaching sustained clinical remission (at week 48 and 60), will roll-over into SPARTACUS Phase B. All other patients will be discontinued and will be treated with standard-of-care medication (including TNFi, if in accordance with Belgian reimbursement criteria).
15801947|NCT04435275|Other|Virtual Assistant first, then Human Coach|Instructions to aid healthcare worker adherence to proper PPE and intubation and extubation procedure is given by a VA (e-coach) in place of a safety officer (a human coach).
15801948|NCT04435275|Other|Human Coach first, then Virtual Assistant|instructions to aid healthcare worker adherence to proper PPE and intubation and extubation procedure is given by a safety officer (a human coach).
15801949|NCT04435262|Other|Remote Monitoring|Remote Monitoring Follow-up
15801951|NCT04435236|Procedure|Cervical ESP block|Cervical ESP block will be performed as described by Elsharkawy at al. (7). ISB block will be performed in transverse orientation of the ultrasound probe to visualize the trunks of the brachial plexus between the anterior and middle scalene muscles
15801952|NCT04435223|Biological|biological assays in particular on the lipid metabolism|bioassays carried out on samples already collected and conserved
15801953|NCT04435210|Drug|Hydralazine|Participants in this group will receive 10mg of hydralazine intravenously. This will be repeated every 30 minutes if the blood pressure is equal to or more than 160/110 mmHg after the last dose, up to maximum of five doses.
15801954|NCT04435210|Drug|Nifedipine|Participants in this arm will receive 20mg of nifedipine and the blood pressure will be measured 30 minutes after the dose. This will be repeated every 30 minutes if the blood pressure is equal to or more than 160/110 mmHg after the last dose, up to maximum of five doses
15801955|NCT04435197|Drug|Pembrolizumab Injection|Pre-operative Pembrolizumab+chemoradiotherapy
15801956|NCT04435184|Drug|Crizanlizumab|Crizanlizumab 5.0 mg/kg in 100 ml IV once.
15801957|NCT04435184|Other|0.9% saline|0.9% saline 100 ml IV once.
15801958|NCT04435171|Procedure|Renal transplantation|Open or robot assisted renal transplantation
15801959|NCT04435158|Drug|SHR-1222|Pharmaceutical form: water injection Route of administration: subcutaneous injection
15801960|NCT04435158|Drug|Placebo|Pharmaceutical form: water injection Route of administration: subcutaneous injection
15801961|NCT04435145|Behavioral|Sugar-sweetened beverage warning label|A sugar-sweetened beverage warning label appropriate for the college-aged population was developed and applied to beverage stations at one large campus dining hall
15801962|NCT04435132|Device|PCL under fluoroscopy with the aid of the robotic device|During the surgery, the robot was positioned over the estimated insertion point. It was aligned to be parallel to the fluoroscope imaging plane as much as possible. The needle is to be placed through the holder, and slightly penetrate the surface of the skin. An x-ray image is then taken to ensure that the whole device can be seen on the screen. Image calibration is then performed through the software GUI. After which, the clinician is also to perform needle tip selection. After which, needle alignment will then be performed. Once needle alignment is complete, the clinician will then advance the trocar needle into the patient's body, using the fluoroscopy to judge the penetration depth. Once the target has been reached, the needle style is to be extracted. The indication of leakage of fluid through the outer needle confirms the success of the procedure.
15801963|NCT04435106|Drug|Opaganib|Study participants received opaganib 2 x 250 mg capsules (500 mg) every 12 hours in addition to Standard of Care
15801964|NCT04435106|Drug|Standard of Care|Study participants received Standard of Care
15803543|NCT04421872|Other|receiving general anesthesia|patients receiving surgery under general anesthesia
15801965|NCT04435093|Other|MFM-Play|Neuromuscular patients will complete five items of the MFM (items 18 to 22) either conventionally or using the MFM-Play with 2 different therapists, on the same day. The order of the MFM type completion will be determined by randomization. Both therapists will rate items 18 to 22 blindly.
15801966|NCT04435067|Genetic|Analysis of genetic mutations and the gene expression profile of lung metastasis and primary neoplasia|The mutational analysis of the main oncogenes and tumor suppressor genes involved in the genesis and tumor progression will be performed on the genomic DNA extracted from each sample using the Ion Torrent TM Oncomine TM Comprehensive Assay version 3 (OCAv3) kit. This panel includes 161 cancer-related genes and allows the identification of all genomic alterations affecting oncogenes and recurrently altered tumor suppressor genes in solid tumors. The study of gene expression will be carried out using Nanostring Technology using the Pancancer IO 360 TM panel which allows simultaneous analysis for each sample of multiple mRNAs associated with crucial pathways in carcinogenesis and the immunological profile of the tumor, defining its up and down conditions gene regulation.
15801967|NCT04435067|Other|Radiomics analysis on TAC imaging at diagnosis of lung metastasis and, if possible, of the primary tumor|This study will be performed using the SPAARC IBSI (International Biomarker Standardization Initiative) compliant software implemented in the MatLab environment (MathWorks, Boston, USA) through several steps: (a) CT imaging retrieval, (b) image segmentation and rendering, (c) feature extraction and (d) qualification/quantification. Approximately 200 radiomics characteristics will be extracted, such as: Morphology, Statistical, Intensity Histogram, Gray Level Co-occurrence Matrix 3D_average, Gray Level Co-occurrence Matrix 3D_combined, Gray Level Run Length 3D_average, Gray Level Run Length 3D_combined, Gray Level Size Zone Matrix 3D, Neighbor Gray Tone Difference Matrix 3D, Gray Level Distance Zone Matrix 3D.
15801968|NCT04435054|Diagnostic Test|Non-invasive blood-based and imaging-based tests for the screening of NAFLD-related advanced fibrosis.|"Non-invasive blood biological tests - NAFLD Fibrosis Score, FIB-4, Fibrotest, FibrometerNAFLD
~Non-invasive imaging:
~- Transient elastography (FibroScan), Shear Wave imaging, Magnetic resonance imaging (MRI-PDFF and MRE) in a subgroup of participants."
15801969|NCT04435028|Drug|Ketotifen 1 MG|Ketotifen is added to patients on anthracycline-containing chemotherapy for 6 months
15801970|NCT04435015|Drug|Camostat Mesylate|Participants will be given Camostat mesylate three times daily.
15801971|NCT04435015|Drug|Microcrystalline Cellulose, NF|Participants will be given Microcrystalline Cellulose (placebo) three times daily.
15801972|NCT04435002|Other|Acupressure|Acupressure technics applied to (Liv- 4 , Ht-7 Bilateral, Liv-3 Bilateral, Anmian Bilateral, Yin-Tang unilateral ve Sp-6 Bilateral)
15801973|NCT04434989|Radiation|Stereotactic Body Radiation Therapy|SBRT for perivascular HCC
15801974|NCT04434989|Procedure|radiofrequency ablation|RFA for perivascular HCC
15801975|NCT04434950|Behavioral|Promoting and implementing repeated HIV self-testing and online real-time counseling|At baseline, Month 6 and Month 12, participants will view an online video clip promoting the needs for HIV testing in general and HIV self-testing with online real-time counseling. A free HIV self-testing kit will be sent to participants. An HIVST administrator will provide online real-time pre-test and post-test counseling.
15801976|NCT04434937|Drug|parsaclisib|parsaclisib will be taken orally QD with water without regard to food except on mornings of PK clinic visits
15801977|NCT04434885|Other|Clinical and imaging examination of symptoms and signs suggestive of axial involvement|Clinical and imaging examination including X-rays and magnetic resonance imaging of sacroiliac joints and spine
15801978|NCT04434872|Procedure|Colonoscopy|Fecal microbiota transplantation through colonoscopy
15801979|NCT04434872|Procedure|Gastroscopy|Fecal microbiota transplantation through gastroscopy
15801980|NCT04434872|Drug|Fecal Microbiota|
15801981|NCT04434872|Procedure|Enema|Fecal microbiota transplantation through enema
15801982|NCT04434859|Other|No intervention|No intervention
15801983|NCT04434820|Device|External negative pressure dressing system (Yuwell 7E-A portable suction unit)|A portable suction unit that will deliver 125 mm Hg of continuous pressure to the dressing and will remove exudates into a disposable canister for 4 days.
15801985|NCT04434794|Biological|mesenchymal stem cells|autologous mesenchymal stem cells
15801986|NCT04434794|Other|standard treatment|standard treatment according to clinical protocols
15801987|NCT04434768|Biological|UMSC01|There will be one dose of IV administration in patients with acute ischemic stroke, or one dose of IV administration followed by low or high doses of IA infusion for acute ischemic stroke with or without bridging therapy (i.e. Intravenous rt-PA thrombolysis or intraarterial thrombectomy) with 12 months of follow up after the first treatment.
15801988|NCT04434755|Other|health care professionals' exposure to bioethical issues|health care professionals were differentiated considering the work context and the type of patients cured
15801989|NCT04434742|Other|Complex interventions|An advanced practice nurse (APN) from a hospital discharge team visited them to familiarize him/herself with their condition and prepare a discharge plan. A face-to-face or telephone call handover between the APN and the project nurse case manager (NCM) was performed before the client was discharged. The past and current medical conditions, medical and nursing management, and follow-up appointments were discussed. After discharge home, the NCM, functioning as the leader of health-social care team, conducted the initial assessment in the first home visit to identify the client's health and social problems within one week of discharge. Community workers, supervised by both the nurse case manager and social worker, provided telephone follow-up and subsequent home visits to monitor the client's progress and provide support when necessary.
15801990|NCT04434742|Other|Usual care|Social call was given to this group.
15801991|NCT04434729|Device|Fetal embolization of vein of Galen malformation using Target XL and XXL Detachable Coils|The study involves a single fetal intervention of maternal transuterine, fetal transcranial torcular puncture and median prosencephalic vein embolization. Detachable platinum coils (Target XL and XXL Detachable Coil, Stryker Neurovascular) will be used to pack the prosencephalic varix.
15802015|NCT04434534|Dietary Supplement|Hipocaloric Diet with Açaí Juçara|Daily consumption of Açaí Juçara pulp (200g) and nutritional adequacy of meals in individualized diet plans calculated for each participant.
15802016|NCT04434534|Other|Hipocaloric Diet|Nutritional adequacy of meals in individualized diet plans calculated for each participant.
15801992|NCT04434716|Device|Feasibility of wearing a Readiband to monitor Sleep and Fatigue|On day one of the study participants will complete a demographic survey. On day one, every seventh day and at the end of the study each participant will complete all the scales; The Minnesota Living with Heart Failure Questionnaire (MLHFQ) and Self-Care of Heart Failure Index will be completed on day one and day 60. At the end of the intervention an Interview will be conducted to assess participants experiences using the Readiband: On a scale of 0-10, how would you rate your digital literacy? 2) Why that number? 3) Tell me about a day using the readiband? 4) Were there any challenges to wearing the band, forgetting to wear it, level of comfort wearing the band? Anything else etc..? 5) How did the digital tools enhance your health? 6) Did the use of digital tools cause you to take a proactive approach rather than a reactive approach to your health? 7) As I use the readiband in a next study, what suggestions do you have for me?
15801993|NCT04434703|Procedure|Platelet rich fibrin (PRF)|following atraumatic extraction of the tooth using periotomes , 10 ml of patient's blood will be drawn by vein puncture of the antecubital vein and prepared in a centrifuge at 3000 rpm for 10 minutes then criss horizontal mattress suture will be applied to close the extraction wound
15801994|NCT04434703|Procedure|Advanced platelet rich fibrin (A-PRF)|following atraumatic extraction of the tooth using periotomes , 10 ml of patient's blood will be drawn by vein puncture of the antecubital vein and prepared in a centrifuge at 1300 rpm for 8 minutes then criss horizontal mattress suture will be applied to close the extraction wound
15801995|NCT04434703|Procedure|blood clot|following atraumatic extraction of the tooth using periotomes, no bio-addative will be added and criss horizontal mattress suture will be applied to close the extraction wound
15801996|NCT04434690|Procedure|Simultaneous bilateral total knee arthroplasty|Two surgeons bilateral TKA group
15801997|NCT04434690|Procedure|Sequenced bilateral TKA|Single surgeon bilateral TKA group
15801998|NCT04434677|Radiation|Hypofractionation|3D conformal Radiotherapy whole breast irradiation +- Supraclavicular fossa using Linear Machine (6-15 MV energy) 40.05 Gray (2.67 Gy/ fx) over 15 fractions with or without boost over 3 weeks
15801999|NCT04434677|Radiation|ultraHypofractionation|3D conformal Radiotherapy whole breast irradiation +- Supraclavicular fossa using Linear Machine (6-15 MV energy) 26 Gray (5.2 Gy/fx) over 5 fractions over 1.5 weeks
15802000|NCT04434664|Drug|Amlodipine Besylate|The interventions will be implemented in random order in a crossover (AB-BA) design, separated by an approximately one-week washout period
15802001|NCT04434664|Drug|Metoprolol Succinate|The interventions will be implemented in random order in a crossover (AB-BA) design, separated by an approximately one-week washout period
15802002|NCT04434651|Procedure|SPGB|Sphenopalatine Ganglion Block using 2% lidocaine in block group. Sphenopalatine Ganglion Block is performed by a hollow culture swab that is connected with a 21-gauge a syringe filled with three ml 2% lidocaine, inserted parallel to the floor of the nose until resistance is felt. The swab is at the posterior pharyngeal wall superior to the middle turbinate. The applicator was kept in the nostril for five to ten mins. The same procedure is done also in the second nostril SPGB using normal saline is performed in the control group
15802003|NCT04434638|Other|Transitions of Care Coordinator|We developed the Transition of Care Coordinator (TOCC) program to aid in the completion of the diagnostic evaluations as well as in the transition out of the acute care hospital setting. In the TOCC intervention, the stroke nurse navigator completed eight specific tasks: (1) met the patient and family within 48 hours of admission, (2) identified patient home location and insurance status, (3) coordinated communication between treating providers (neurologists, cardiologists, etc.) regarding pending diagnostic tests, (4) followed up physical, occupational, and speech therapy teams' recommendations for rehabilitation, (5) attended daily multi-disciplinary rounds, (6) facilitated referrals to acute and subacute rehabilitation facilities with case managers, (7) assisted beside nurses in providing tailored stroke education and discharge instructions to patients and families, and (8) arranged stroke clinic follow-up appointments.
15802004|NCT04434638|Other|Usual Care|Patients received the current, ongoing method of care coordination by members of the multi-disciplinary stroke team. The current practice is that members of this multi-disciplinary team meet with each other every weekday morning to discuss the discharge plan of care for each stroke patient on the inpatient stroke service. Physicians, nurses, rehabilitation therapists and case managers are then individually responsible for talking to patients and their families/caregivers about the different aspects of the plan of care.
15802005|NCT04434625|Drug|Polyethylene glycol|Before colonoscopy, patient-related and procedure-related parameters were collected by one investigator in each center. In MI group, a procedure-based score, used for predicting inadequate bowel preparation, was calculated for each patients. Patients with score ≥3 were asked to taking another dose of PEG (1.5L) within 1-2 hours. Colonoscopy was performed in afternoon (about 4h after drinking PEG). Patients with score<3 in IM group and those in the control group underwent colonoscopy directly
15802006|NCT04434612|Device|OXSIGHT smart glasses|OXSIGHT smart glasses are head-mounted electronic LVAs designed for LV patients with visual field loss.
15802007|NCT04434599|Device|Fluoroscopically guided ablation|Catheter ablation of the cavotricuspid isthmus using ablation catheters guided by fluoroscopy
15802008|NCT04434599|Device|Contact force guided ablation|Catheter ablation of the cavotricuspid isthmus using ablation catheters guided by contact force measurement and 3D electroanatomic mapping
15802009|NCT04434599|Device|Local impedance guide ablation|Catheter ablation of the cavotricuspid isthmus using ablation catheters guided by local impedance measurement and ultra-high density 3D electroanatomic mapping
15802010|NCT04434586|Device|femoropopliteal revascularization for TASC C or TASC D lesion|Femoropopliteal revascularization: ATL or ATL/stenting for TASC C/D lesions. Control group: only angiography 2D final control. Experimental group: angiography + OCT control
15802011|NCT04434573|Other|Observation study|French-speaking digestive surgeons are invited to respond to an online survey consisting of 13 common clinical situations concerning primary or asymptomatic incisional hernia pathology where a therapeutic decision is requested.
15802012|NCT04434560|Drug|Nivolumab|Nivolumab will be given at the FDA-approved dose of 3 mg/kg.
15802013|NCT04434560|Drug|Ipilimumab|Ipilimumab will be given at the FDA-approved dose of 1 mg/kg.
15802014|NCT04434547|Biological|PRP|During the mock embryo transfer on oocyte retrieval day, 1ml of PRP was infused inside the uterus
15802017|NCT04434521|Behavioral|Questionnaire|Questionnaire about habits in terms of near vision activities
15802018|NCT04434521|Other|Eye examination|"The eye examination involves the following measurements:
~Distant vision phoria with Thorington method
~Close vision with Thorington method
~Objective eye-to-eye refraction with self-refractometer
~Binocular objective refraction with autorefractometer
~Monocular/biocular/binocular refraction with Nidek TS610
~SiView automatic refraction
~Humphriss binocular refraction
~MOU Binocular refraction"
15802019|NCT04434508|Procedure|laparoscopic right hemicolectomy with CME and central v|laparoscopic right hemicolectomy with CME and central v
15802020|NCT04434508|Procedure|Open right hemicolectomy with CME and central v|Open right hemicolectomy with CME and central v
15802021|NCT04434495|Biological|PRP|PRP injection into uterine cavity
15802022|NCT04434482|Drug|IMP4297|The dose levels will be escalated following a modified 3+3 dose escalation scheme.
15802024|NCT04434456|Device|CGuard stent implantation|CGuard stent implantation in the carotid artery with symptomatic, dissecting or enlarging aneurysm
15802025|NCT04434443|Other|trunk exercise on unstable exercise|Participants would receive exercises on unstable surface. Started from supine position, participants had abdominal drawer-in maneuver with soft foam under the pelvic. Lower trunk rotation, bridging and abdominal muscles isometric contraction exercises were also used in this exercise during supine position, with different unstable surfaces used. Including soft foam under the feet, then progressed to BOSU ball under the feet, then progressed to the a BOSU ball under the feet combined with pelvic on soft foam. During sitting, BOSU ball and Swiss ball were used as unstable surface. Pelvic anterior-posterior tilt, lateral tilting, rotation, lifting, and stepping with arm swing were used in this position.
15802026|NCT04434443|Other|Upper limb range of motion exercise|Upper limb range of motion exercise with trunk fully supported
15802027|NCT04434430|Drug|Gabapentin|Oral Gabapentin 600 mg
15802028|NCT04434430|Other|Placebo|Oral NaCl 500 mg
15802030|NCT04434404|Drug|L-Carnitine 500Mg Oral Tablet|"eighty-three eligible patients were recruited 33, 25, and 25 patients in the control group, L-carnitine group, and, Silymarin group respectively, completed the study
~without cardioprotective agents in a dose of 50 mg/m2. L-carnitine group received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus L-carnitine 3 gm L-carnitine® capsules obtained from (MEPACO) was taken PO one day before chemotherapeutic cycle and 1gm /day during the following 21 days. Silymarin group received anthracycline-containing chemotherapy in a dose of 50 mg/m2 plus Silymarin as cardioprotective agent.140 mg (Legalon ® 140 mg capsule obtained from (MEDA). Silymarin was taken PO once daily after meals during the chemotherapeutic cycle. The treatment period was 6 months."
15802031|NCT04434391|Other|QF-PCR for GBS screening|QF-PCR for GBS screening in pregnant women,compared with GBS culture test.
15802032|NCT04434378|Drug|Tamsulosin|0.4 mg tamsulosin will be given to a randomized group of patients
15802033|NCT04434378|Drug|Placebo|placebo will be given to a randomized group of patients
15802034|NCT04434365|Drug|Berberine|Berberine 100 mg twice daily for 4±1 weeks (Stage 1); then, 200 mg twice daily for 4±1 weeks (Stage 2); then, 300 mg twice daily for 4 weeks (Stage 3).
15802035|NCT04434365|Drug|Aspirin|Aspirin 100 mg once daily for 12±1 weeks.
15802036|NCT04434365|Drug|Clopidogrel|Clopidogrel 75 mg once daily for 12±1 weeks.
15802037|NCT04434365|Drug|Statin|Statins once daily for 12±1 weeks.
15802038|NCT04434352|Device|Storz Duolith Low-Intensity Shockwave Therapy|"A: Sham - the sham uses an attachment on the hand held probe that mimics the shockwave device, however it does not deliver any shockwaves. Sham will be delivered twice weekly for 3 weeks in the same manner as the LiSWT. The sham treatment will take about 20 minutes to complete.
~B: LiSWT delivered twice weekly for 3 weeks, comprising of 3000 shockwaves delivered to the distal penis (1000 shockwaves), base of penis (1000 shockwaves), and corporal bodies on the perineum (500 shockwaves to each crura). LiSWT is delivered into the penile tissue by a small hand held probe that produces low intensity shockwaves. A tranducer head is placed on the left and right sides of the penis. Treatment takes about 20 minutes to complete."
15802039|NCT04434339|Procedure|erector spinae block|A volume of 20 ml for each side of erector spinae plane with 0.25% plain bupivacaine
15802040|NCT04434339|Procedure|transversus abdominis block|A volume of 20 ml for each side of transversus abdominis plane with 0.25% plain bupivacaine
15802041|NCT04434326|Drug|[14]CM082 suspension|Before administration, the solid powder for administration was placed at room temperature. 40 ml drinking water was added into the drug container to prepare the suspension for the subjects to take. After that, 200 ml drinking water was used to repeatedly rinse the drug container for many times, and the subjects continued to take the lotion. Take care not to spill the liquid out of the bottle when shaking
15802042|NCT04434313|Device|Delivery of iStride™ device gait treatment using telemedicine|The gait device used in this study mimics the actions of the split-belt treadmill but can be used during overground walking and in one's own home, thus enabling long-term training. This device does not require any external power and is completely passive; all necessary forces are redirected from the natural forces present during walking. This research aims to adapt the delivery mechanism of treatment with the iStride™ device to include telemedicine. The telemedicine platform of reference in this study, the Moterum Digital Platform, is an integrated therapeutic platform which offers an activity library, real-time video conferencing, and outcomes tracking. Our primary study objective is to determine if telemedicine is a safe and feasible delivery method for treatment with the iStride ™ gait device.
15802043|NCT04434300|Drug|Daptomycin|Compare the pharmacokinetic of subcutaneous (SC) and intravenous (IV) routes in the same patient.
15802044|NCT04434300|Drug|Daptomycin|Compare the pharmacokinetic of subcutaneous (SC) and intravenous (IV) routes in the same patient.
15802045|NCT04434274|Drug|Micronized Purified Flavonoid Fraction|Based on the (non-)use of adjuvant phlebotropic therapy in the postoperative period.
15802046|NCT04434261|Diagnostic Test|PT-PCR test for SARS-CoV-2|Screening test for the diagnosis of SARS-CoV-2 in asymptomatic patients
15802047|NCT04434248|Drug|Favipiravir|200 mg coated tablets
15802191|NCT04432883|Behavioral|Sham Comparator: Placebo cathodal tDCS + Speech and language|Speech and Language training involves a combined semantic feature analysis and phonological components analysis treatment. .
15802048|NCT04434248|Drug|Standard of Care|Standard of Care will be prescribed in accordance with the recommended treatment regimens presented in the Russian guidelines for the prevention, diagnosis and treatment of COVID-19 according to the decision of the Investigator.
15802049|NCT04434235|Other|axial load|With a helmet with Velcro fastener we will add additional weight to produce axial load on the cervical spine
15802050|NCT04434222|Device|Compressive stockings|Compressive stockings with built in Orthotimer Sensor
15802051|NCT04434209|Device|Subject management guided by NephroCheck® test|NephroCheck® is a device using biomarkers to identify subjects at risk of sepsis-associated acute kidney injury
15802052|NCT04434209|Other|Standard of Care|Standard of Care patient management
15802055|NCT04434183|Device|Exercises of rehabilitation|Compare and evaluate of the effects of the routin physical medicine and rehabilitation programs in impingement patients
15802056|NCT04434170|Drug|Sacubitril-Valsartan|outpatients who start treatment with sacubitril/valsartan according to guidelines will andergo cardiopulmonary exercise testing evaluation
15802057|NCT04434144|Drug|Ivermectin + Doxycycline|SARS-CoV-2 infection was confirmed by RT PCR in every case. For group A, Ivermectin 200mcg/kg single dose and Doxycycline 100mg BID for 10 days were given. For group B, Hydroxychloroquine 200mg BID for 10 days and Azithromycin 500mg single daily dose for 5days was given. Before advising the contraindications and possible adverse effect and drug interactions were kept in consideration. Incase of asymptomatic patients, repeat sample collection (nasopharyngeal and throat swab) for PCR was done on 5th day. For the symptomatic patients, this duration was on the 3rd nonsymptomatic day from the first day of drug intake. In the case of positive PCR, the test was repeated after 2days and onward.
15802058|NCT04434144|Drug|Hydroxychloroquine + Azithromycin|SARS-CoV-2 infection was confirmed by RT PCR in every case. For group B, Hydroxychloroquine 400mg first day then 200mg BID + Azithromycin 500mg BID for 5 days were given. For group B, Hydroxychloroquine 200mg BID for 10 days and Azithromycin 500mg single daily dose for 5days was given. Before advising the contraindications and possible adverse effect and drug interactions were kept in consideration. Incase of asymptomatic patients, repeat sample collection (nasopharyngeal and throat swab) for PCR was done on 5th day. For the symptomatic patients, this duration was on the 2nd nonsymptomatic day from the first day of drug intake. In the case of positive PCR, the test was repeated after 2days and onward.
15802059|NCT04434131|Drug|Convalescent Plasma|Study subjects will receive 1 unit (200mL) of SARS-CoV-2 convalescent plasma collected from a single donor who recovered from COVID-19.
15802060|NCT04434118|Drug|Traditional antirheumatic drugs|Hydroxychloroqine, Methotrexate, Glucocorticoids, Leflunomide, and Sulphasalazine
15802061|NCT04434105|Drug|platlet rich plasma (PRP)|Platelet-rich plasma (PRP) promotes angiogenesis, neurogenesis, and nerve regeneration, also it could reduce swelling and inflammation of the flexor tenosynovitis.
15802062|NCT04434105|Drug|Triamcinolone Acetonide|40 mg triamcinolone acetonide
15802063|NCT04434105|Drug|Saline|Saline
15802064|NCT04434092|Drug|Crovalimab|Crovalimab will be administered at a dose of 1000 mg IV (for participants with body weight between 40 and 100kg) or 1500 mg IV (for participants with body weight >=100kg) on Week 1 Day 1. On Week 1 Day 2 and on Weeks 2, 3 and 4, it will be administered at a dose of 340 mg SC. For Week 5 and Q4W thereafter, it will be administered at a dose of 680 mg SC (for participants with body weight between 40 and 100kg) or 1020 mg SC (for participants with body weight >=100kg). Dosing schedule will be as described above.
15802065|NCT04434092|Drug|Eculizumab|Eculizumab will be administered at a dose of 600 mg for the first 4 weeks, followed by maintenance doses of 900 mg starting on Week 5, as per the dosing schedule described above.
15802066|NCT04434079|Other|Regular critical care|Clinical demographic data, daily and cumulative FB (input minus output) with and without insensible fluid losses, and daily and total BW changes are recorded, as well as survival outcome.
15802067|NCT04434066|Procedure|Total Laparoscopic Hysterectomy|Participants will be randomized into either abdominal or vaginal morcellation at time of total laparoscopic hysterectomy
15802068|NCT04434053|Device|MIETHKE M.blue®|The programmable shunt will be adjusted through the MIETHKE M.blue® valve.
15802069|NCT04434053|Device|MIETHKE proGAV 2.0® (with SA 2.0®)|The programmable shunt will be adjusted through the MIETHKE proGAV 2.0® valve that will be implanted together with a shunt-assistant SA 2.0®.
15802072|NCT04434014|Dietary Supplement|proper diet|diet containing all essential vitamins
15802073|NCT04434001|Drug|Fibrinogen Concentrate Human|Treatment of acquired postoperatively fibrinogen deficiency as assessed by ROTEM FIBTEM test.
15802074|NCT04434001|Drug|Prothrombin Complex Concentrate|Treatment of acquired postoperatively thrombin generation deficiency as assessed by ROTEM EXTEM test.
15802075|NCT04434001|Biological|Fresh Frozen Plasma|Treatment of acquired postoperative coagulopathy as assessed by ROTEM FIBTEM and INTEM tests.
15802076|NCT04433988|Drug|Pentoxifylline|Pentoxifylline 400 mg SR tablet
15802077|NCT04433988|Drug|Placebo|Placebo tablet
15802078|NCT04433975|Behavioral|Psychosocial Pain Management (PPMI)|The main theme of the treatment is to provide participants with new ways of thinking and coping skills related to managing pain and opioid use in order to increase the likelihood the participant may remain in buprenorphine treatment.
15802079|NCT04433975|Behavioral|Enhanced Usual Care (EUC)|The EUC condition is designed to match the PPMI condition in terms of the non-specific aspects of receiving support for pain, substance use, and receiving monitoring of buprenorphine adherence.
15802080|NCT04433962|Other|Exercise training|
15802081|NCT04433949|Other|Best Practice|Receive standard of care
15802082|NCT04433949|Radiation|Low Dose Radiation Therapy|Undergo LDRT
15802192|NCT04432857|Drug|AN0025|oral administration
15802193|NCT04432857|Drug|Pembrolizumab|Infusion
15802194|NCT04432844|Procedure|Biplanar Ultrasound guided Internal Jugular Vein Cannulation|Using Philips EPIQ elite ultrasound system with a high-frequency 3D and 4D volume linear array transducer (USG XL 14-3) to obtain the biplanar imaging of Internal jugular vein cannulation.
15803683|NCT04420793|Other|Questionnaire|3 voice recording tasks and 1 text entry task will be performed.
15802083|NCT04433936|Diagnostic Test|Pentacam tomography|The Pentacam maps were analyzed. The following anterior and posterior corneal surface parameters were evaluated by the Scheimpflug system: Kf, Ks, Kmax. The pachymetric map was analyzed, including CCT at the apex of the geometric center and CTmin. PPIavg, PPI min and PPI max were calculated . The Ambrósio relational thickness (ART) was calculated The posterior corneal elevation maps were evaluated and the posterior corneal elevation values relative to this reference were recorded. The back difference elevation and multimetric D index values were extrapolated from the difference map of the Belin/Ambrósio-enhanced ectasia display of the Pentacam system.
15802084|NCT04433923|Device|Phototherapy with aluminum foil|
15802085|NCT04433923|Device|Phototherapy without aluminum foil|
15802086|NCT04433910|Drug|Convalesscent Plasma|Transfusion
15802087|NCT04433897|Other|Questionnaire|"All women fulfilled 3 questionairres
~TANGO
~ICIQ -N
~Perceived Stress Scale"
15802088|NCT04433884|Device|Endotracheal intubation using a laryngoscope|Patients will undergo intubation using 2 different types of laryngoscopes and their hemodynamic response would be recorded
15802089|NCT04433871|Other|No intervention, observational|No intervention, observational
15802091|NCT04433845|Drug|Psilocybin|Open-label
15802092|NCT04433806|Behavioral|Referral to weight loss program|16 weeks Diabetes Prevention Program based weight loss program at a local community partner
15802093|NCT04433793|Behavioral|Yoga therapy|"One yoga session will last one hour. It consists of physical exercises (asanas), conscious breathing (Pranayama) and deep relaxation (Savasana). The subsequent body exercises are structured from lying to sitting to standing. The following sequence of exercises will be repeated in each yoga unit: 1) Relaxation: conscious breathing, body scan, mindfulness 2) Vein pump 3) Pelvis and back rotation (adapted variation of the nakrasana) 4) Pelvis opening (adapted variation of the supta baddha konasana) 5) Shoulder bridge (setu bandha sarvangasana) 6) Forward folds (Paschimottanasana and variations with Pranayama) 7) Backbend: intense east stretch (Purvottasana) 8) Diagonal static yoga cat (Majariasana 1 and resting pose) 9) Standing exercise 10) Upward Salute(Urdhva Hastasana) 11) Warrior 1 (Virabhadrasana 1) 12) Warrior 3 (Virabhadrasana 3) 13) Tree (Vrkasana variation) 14) Relaxation (Savasana)."
15802094|NCT04433780|Drug|Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate|DOR/3TC/TDF 100/300/300 mg once daily fixed-dose combination switched from either EFV/TDF/FTC or DTG/TDF/3TC
15802095|NCT04433767|Drug|Transdermal Nicotine patch|"Participants will begin a 12- week open label trial of transdermal nicotine patch during the day and remove it at night (16 hours). Dose titration starting at 3.5 mg patch/daily to maximum of 21mg patch/daily.
~After week 12 , dose will be slowly tapered over 3 weeks."
15802096|NCT04433754|Other|biochemical analysis|cRP, d-dimer levels and lymphocyte counts will be compared
15802097|NCT04433741|Drug|Oxytocin|Oxytocin administered intravenously
15802098|NCT04433741|Drug|Placebo|Placebo administered intravenously
15802099|NCT04433715|Diagnostic Test|ICIQ-SF|All participants completed ICIQ-SF,
15802100|NCT04433715|Diagnostic Test|UDI-6|All participants completed UDI-6
15802101|NCT04433715|Diagnostic Test|IIQ-7|All participants completed IIQ-7
15802102|NCT04433702|Device|Mercury™ Multi-Pressure Dial (MPD) Experimental Goggle|"The Mercury™ MPD applies negative pressure to one of the two goggles inducing an IOP reduction of 10 mmHg. This is randomized for each subject in the trial.
~The Mercury™ MPD consists of:
~Goggles: seal against the bony orbit with straps around head. The goggles separately enclose each eye, with each eye individually connected to a pressure-modulating pump.
~Programmable pump: applies negative pressure inside the goggles via clear tubing attached to a handheld device"
15802103|NCT04433702|Device|Mercury™ Multi-Pressure Dial (MPD) Placebo Goggle|"The Mercury™ MPD applies no negative pressure to one of the two goggles eliciting no IOP reduction. This is randomized for each subject in the trial.
~The Mercury™ MPD consists of:
~Goggles: seal against the bony orbit with straps around head. The goggles separately enclose each eye, with each eye individually connected to a pressure-modulating pump.
~Programmable pump: applies negative pressure inside the goggles via clear tubing attached to a handheld device"
15802104|NCT04433689|Device|Non-Contact measurement of corneal properties|Corneal Properties will be measurement with the non-contact Corvis ST Air-Puff Tonometer by Oculus Inc.
15802105|NCT04433676|Other|no intervention|
15802106|NCT04433663|Other|Mentalization -based therapy using novel tool to demonstrate eating behavior and control axis|"To address the gap between theory and practice in the treatment of eating disorders we y developed a novel axis, ECOSA, to better conceptualize the complex interaction between eating style, control conditions, and the impact of the emotional brain versus the thinking brain. A randomized pilot study was used to evaluate the integration of this tool in a mentalization-based treatment compared to treatment as usual (IPT).
~Methods: The suggested tool was tested in a randomized blinded feasibility study using the Eating Attitudes Test (EAT-26) and the Reflective Functioning Questionnaire RFQ - as the main outcome."
15802107|NCT04433650|Device|Pictorial support in person-centred care for children (PicPecc)|"Phase A: The child has the protocol for methotrexate treatment, the healthcare professionals have one workshop that containing person-centred care, universal design, distress, symptom management and the digital reporting and communication tool.
~Phase B: The child has everything in phase A. In addition, the child use the digital reporting and communication tool that has a thermometer (graded from zero (green) to ten (red)). The result of the assessment is visualized as a face (mimic and colour represents the intensity of the symptom and/or emotion (i.e., anxiety, appetite, fear/worries, how I´m feeling today, nausea, pain, sleep, and tiredness)). The digital reporting and communication tool has a body figure for location of pain, pictures for the type of pain, and an open question. There is an avatar and a gamification part, e.g., the child gets a pet after assessing the symptoms/emotions. The child reports in the app, and the child decides the frequency of assessments."
15802108|NCT04433637|Dietary Supplement|Cake + fruit juice|Cake+fruit juice experiment group, pregnant were allowed to consume fruit juice and cake, and it was expected that half an hour would pass after feeding to get NST.
15802195|NCT04432831|Drug|Faricimab|Faricimab will be administered by intravitreal (IVT) injection into the study eye according to the personalized treatment interval (PTI) dosing regimen.
15802255|NCT04432454|Drug|Lasofoxifene and abemaciclib (VERZENIO (R)).|Lasofoxifene 5 mg given once a day orally and abemaciclib 150 mg given twice a day orally.
15802256|NCT04432441|Other|Scapular flexion exercise|This group realize a scapular retraction exercise during a month
15802109|NCT04433637|Other|Video group|Music with motivational video experimental group, pregnant women were provided with fruit juice and cake, and it was expected that half an hour would pass after feeding to get NST. During this waiting period, the researchers were informed about the development and changes in the body and the fetus specific to the gestational week and NST. Later, NST was applied, and during the procedure, the pregnant women were watched with music that provides relaxation with the video regarding the fetal development appropriate for the gestational week and changes in the mother.
15802110|NCT04433624|Other|Group (B)|Group (B) (n=15): will receive The bilateral ESP blocks were performed by injecting 40 mL of 0.25% bupivacaine (20 mL into each side) into the fascial plane between the deep surface of the erector spinae muscle and the transverse processes of the lumbar vertebrae
15802111|NCT04433611|Drug|2% lidocaine|"intrauterine infusion of 2% lidocaine (Rafa laboratories, Israel) just prior to HyFoSy
~The VAS consisted of a 10 cm line ranging from 0 to 10 (anchored by 0=no pain and 10=very severe pain). Patients were asked to mark the number that represented their perceived level of pain. Based on the VAS scores, the pain level ratings were classified as: mild (rated 1-3), moderate (4-6) or severe (7-10)."
15802112|NCT04433611|Drug|0.9 % normal saline|intrauterine infusion of 0.9 % normal saline
15802113|NCT04433598|Behavioral|Nutrition Education Intervention|Each participant were interviewed by face- to- face using Arabic language, after 1 hour when they finish their assessment by medical doctors. The researcher was collected the data from the participants in a special room for 10-15 minutes, after only one hour of completing the necessary tests with the treating physician to allow participants to go for a meal before the nutrition education starts.12 classes (1:30 hour each session):- 100 participants / 5 days = 20 participants each class was offered twice per day to cover the number of participants and to enhance attendance for them can not attend at first morning. the classes was designed according to health belief model (HBM). The topics were about the type 2 diabetes and its complications,the benefits of diabetes plate and eating vegetables before carbohydrates.
15802116|NCT04433572|Drug|Temsirolimus|0.1 mg/mL temsirolimus, including contrast medium with approximately 75 mg iodine per mL. The dosage will be delivered in a volume of 0.50 mL per cm of target lesion length, up to 30 cm, with +50% allowance for anatomical considerations; for a total volume of up to 22.5 mL and a total dose of up to 2.25 mg in participants assigned to treatment. The same volumes of comparator agent will be delivered in control participants.
15802117|NCT04433572|Drug|Saline placebo|Saline placebo, including contrast medium with approximately 75 mg iodine per mL. The dosage will be delivered in a volume of 0.50 mL per cm of target lesion length, up to 30 cm, with +50% allowance for anatomical considerations; for a total volume of up to 22.5 mL and a total dose of up to 2.25 mg in participants assigned to treatment. The same volumes of comparator agent will be delivered in control participants.
15802118|NCT04433559|Drug|Tadalafil 1,5 mg oral tablets|Use of tadalafil in the treatment of FSIAD
15802119|NCT04433559|Drug|Placebo oral tablets|Use of placebo in control group
15802120|NCT04433546|Drug|Pemziviptadil (PB1046)|Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection
15802121|NCT04433546|Drug|Low Dose (10 mg) Control|Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection (10 mg diluted in sodium chloride to match active drug volume)
15802122|NCT04433533|Drug|Rosuvastatin 20|Patients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of Rosuvastatin 20mg Monotherapy.
15802123|NCT04433533|Drug|Rosuvamibe 10/10|Patients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of rosuvastatin10mg/ezetimibe 10mg combination Therapy
15802124|NCT04433520|Device|Amplatzer™ Trevisio™ Intravascular Delivery System|Amplatzer Trevisio Delivery System is used for facilitating percutaneous, transcatheter implantation of the Amplatzer PFO Occluder, Amplatzer ASO, Amplatzer Cribriform Occluder, Amplatzer Muscular VSD Occluder, and Amplatzer Post-Infarct Muscular VSD Occluder.
15802125|NCT04433507|Procedure|Sleeve gastrectomy|Laparoscopic sleeve gastrectomy (LSG) is performed through a standard 5-port technique. After dissection of the greater curvature of the stomach, a narrow tube-like stomach is created after stapling off the lateral aspect of the stomach using a 40 French bougie as a guide.
15802126|NCT04433507|Procedure|Hiatal Hernia repair|Hiatal hernia repair consists in a circumferential dissection of the diaphragmatic crura to achieve an intra abdominal esophageal length of 2-3 cm. The crura will then be closed anteriorly and posteriorly using nonabsorbable sutures.
15802127|NCT04433494|Drug|TY-302: capsule, 25mg/50mg ; Tamoxifen: tablet,10mg|TY-302 is taken orally. Tamoxifen is taken orally.
15802128|NCT04433481|Drug|Dabigatran|T. Dabigatran 150 mg twice a day
15802129|NCT04433481|Other|Placebo|placebo
15802130|NCT04433468|Device|RIPC|The tourniquet attached to the upper limb was inflated and blocked for 5 minutes, then deflated for 5 minutes to restore blood flow and induce ischemic preconditioning.
15802131|NCT04433429|Dietary Supplement|Liposcudil Plus|
15802132|NCT04433416|Diagnostic Test|hypertension|If the patient has two or more blood pressure values ≥140/90mmHg in a calm state, he is included in this group
15802133|NCT04433403|Other|pathogenic microorganism|Detection of pathogenic microorganisms in adult severe pneumonia by second generation sequencing
15802134|NCT04433390|Drug|Naloxegol|one naloxegol 12.5 mg tablet will be administrated 2 hours before surgery. One 25 mg naloxegol tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days.
15802135|NCT04433390|Drug|inert tablet|one inert tablet will be administrated 2 hours before surgery. One inert tablet per day will be administrated from 24h post-surgery until bowel movement; for maximum 5 days.
15802136|NCT04433377|Procedure|Suprascapular nerve block|A betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg / mL + 2.63 mg / mL; 1 mL), 0.5 % bupivacaine (2 mL) and physiological serum (2 mL) are injected with an in-plane technique using a 22 gauge 90-mm injector
15802137|NCT04433377|Procedure|Subacromial injection|A betamethasone dipropionate plus betamethasone sodium phosphate solution (6.43 mg/mL + 2.63 mg/mL; 1 mL), 2% lidocaine (2 mL) and physiological serum (2 mL) are injected with an in-plane technique using a 21 gauge 38-mm injector.
15802257|NCT04432441|Other|Scapular flexion exercise + electrostimulation|This group realize a scapular retraction exercise added electrostimulation during a month
15802138|NCT04433364|Other|biological samples, questionnaires and interviews|"Biological samples: to study impact of testing positive for SARS-CoV-2 during pregnancy samples taken in routine clinical care, samples from already existing research biobanks and the newly established COPE biobank will be used. Time-points: inclusion, at delivery mother and fetus. Covid-19 positive group only: 48-96 h, 2 months postpartum for mother and fetus.
~Questionnaires: Women and partners in both groups will fill out electronical questionnaires at different time points during pregnancy and until 12 months postpartum based on validated instruments to test for differences in Self-Efficacy, Anxiety and Depression, Health-related quality of life, Sense of Coherence, PTSD Symptoms, Postpartum Bonding, Childbirth experiences and Self-Efficacy of Breastfeeding. The child's health will be assessed regarding infection until 6 weeks of age and development until 4 years.
~Interviews: 24-40 women and partners in both groups. Interviews will be conducted 3 to 6 months after childbirth."
15802139|NCT04433351|Device|Enriched rehabilitation|"The enriched rehabilitation is based on the use of sensory-motor integration in addition to conventional speech therapy. The sensory-motor integration method is based on the Ultraspeech-player software. This software allows therapists to display movements of speech articulators (tongue and lips) recorded on a reference speaker during production of vowels or consonants (isolated or combined). Sagittal movements of the tongue are recorded using ultrasound and front views of lip movements are captured through video imaging.
~During rehabilitation with the Ultraspeech-player software, patients will be seated in front of a computer screen, observe articulatory movements and listen to phonemes. Then, they will be required to repeat each of them five times and move on to the next phoneme, with the agreement of the experimenter."
15802140|NCT04433351|Device|Simple rehabilitation|The simple rehabilitation is based on conventional speech therapy. The conventional speech therapy will be provided by the speech therapist. Classically, the speech therapist uses word production with repetition and naming exercises. The therapist will show the patient series of pictures associated or not with written words, and the patient is required to name them and/or read aloud the word. In case of impossibility to perform the task, the therapist may can help the patient by using the indexing method or by asking the patient to repeat after him/her. According to patient's competencies and progress, the difficulty of reeducation can increase progressively.
15802141|NCT04433338|Other|14-day Low Calorie Diet|"Participants will be asked to:
~Use 4 (women) or 5 (men) Modifast meal replacements per day.
~Daily consume a minimum of 250 grams of (raw) vegetables without dressing.
~Daily consume 100 grams of lean meat/fish/meat analogues.
~Daily consume two spoons of liquid oil
~Daily drink at least 2.0 litres of water, coffee or tea without added sugar or milk, bouillon or sugar-free drinks."
15802142|NCT04433312|Other|Questionnaire|The questionnaire is developed based on a literature review and clinical experience. Initial testing of the questionnaire will be performed with 20 patients to assess the reliability and inter-rater variations. After initial testing, the final questionnaire will be formulated. The first sector of the questionnaire includes patient demographics and baseline characteristics; the second sector is regarding patient clinical condition, diagnosis, and scheduled surgery. The following sector examines the process of delivering the cancellation to the patient and requirements for re-scheduling. Patients will be classified into satisfied or dissatisfied according to the responses in this sector. The following sector addresses the course of care after cancellation and whether the patient conducted the surgery elsewhere or not. The last sector explores the impact of cancellation on patient health, career, and financial aspects.
15802143|NCT04433299|Other|no intervention, observational|no intervention, observational
15802144|NCT04433286|Other|Questionnaire|"This is a cross-sectional survey which will be distributed online between surgeons. The survey was proposed by a consensus of consultants of surgery and revised by an improvement consultant. It consists of a semi-structured questionnaire that is provided in English language. A subsequent translation in different Language will provided based on geographical distribution. The survey will be conducted online through an online survey development cloud-based software (SurveyMonkey®; San Mateo, CA, USA). Participants will be aware of the nature of the survey and informed that they will be listed as co-authors. Collected data will be confidential and anonymous.
~The first sector of the questionnaire includes trainee demographics and baseline characteristics. Then the questionnaire aims to compare the trainee experience before and after the pandemic with focus on research activities, clinical, and surgical practice."
15802145|NCT04433273|Device|Electrical vestibular nerve stimulation|Electrical vestibular nerve stimulation using a headset device
15802146|NCT04433260|Other|Questionnaire including validated tools such as Patient Health Questionnaire (PHQ-9), the 7-item Generalised Anxiety Disorder (GAD- 7), the 7-item insomnia severity index|The electronic survey for phase 1 detailing questions regarding affective symptoms, behaviour and ongoing concerns will be sent and implied consent assumed from responders. A proportion of these patients who give consent to be repeatedly contacted throughout the study period will be recruited into phase 2 of the study at 6 weeks and 4 months
15802147|NCT04433260|Other|Questionnaire, same tools as before, with inclusion of PCL5 questionnaire too.|Follow-up electronic surveys including questions regarding affective symptoms, behavioural changes and mental well-being will be sent at 6-weeks and 4-months following the initial survey. This will be sent to participants from Groups 1-3 that provided consent to receive these follow-up questionnaires.
15802148|NCT04433260|Other|Informed consent|Participants will need to give their consent to participate to the survey after reading PIS
15802149|NCT04433247|Behavioral|Peer Led Group Intervention|Four week dissonance-based program wherein women with body image concerns complete verbal, written, and behavioral activities. The program consist of four 60-minute sessions.
15802150|NCT04433234|Drug|DS-5141b|Administered via subcutaneous injection once weekly
15802151|NCT04433221|Biological|Multiple sarcoma-specific CAR-T cells and sarcoma vaccines|1 infusion, CART 1x10^6~1x10^7 cells/kg via IV and vaccines 1-5x10^6 irradiated cells via subcutaneous injection
15802152|NCT04433208|Dietary Supplement|Complex oligosaccharide|Complex oligosaccharide concentrate
15802153|NCT04433208|Dietary Supplement|Probiotic|Probiotic
15802154|NCT04433208|Other|PPI|Over-the-counter proton pump inhibitor (PPI)
15802155|NCT04433195|Diagnostic Test|Xpert MTB/RIF test|Xpert MTB/RIF performed as the initial diagnostic test for the diagnosis of pulmonary TB
15802252|NCT04432480|Procedure|NIPE (Newborn Infant Parasympathetic Evaluation) monitoring|Non invasive monitor connected to standard anesthesia monitor (no part of the device in contact with the patient) during anesthesia.
15804528|NCT04413383|Other|Wuennenberg Modified Curved Iris Scissors|Modified Silent Curved Iris Scissors
15802156|NCT04433182|Drug|Copanlisib|"Induction phase: 6 cycles of Copa-RB every 28 days according to the following schedule
~Copanlisib (Copa): 60 mg/day i.v. on days 1,8,15
~Rituximab (R): 375 mg/sqm i.v. day 1*
~Bendamustine (B): 90 mg/sqm i.v. days 1-2*
~note: during cycle 1 rituximab can be administered on day 2: in this case bendamustine will be administered on days 2-3; in the case of a frail patient or a patient with high tumor burden copanlisib could be administered on day 1, rituximab on day 2 and bendamustine on days 3-4, at physician discretion.
~Maintenance phase: patients who reach at least SD after induction will receive a maintenance with copanlisib in monotherapy according to the following schedule:
~• Copanlisib: 60 mg/day i.v. on days 1 and 15 in 28-day cycles for 1 year"
15802157|NCT04433169|Drug|All-trans Retinoic Acid|ATRA 20 mg, three times a day, for 28 consecutive days, 28 days per cycle (q4w), 6 planned cycles
15802158|NCT04433169|Drug|VEGFR inhibitor|VEGFR inhibitor
15802159|NCT04433169|Drug|Chemotherapy|chemotherapy
15802160|NCT04433156|Drug|Bortezomib|1.3 mg/m2, hypodermic injection on day 1 and day 4 of each 3-week cycle until disease progression/stable disease after 2/4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.
15802161|NCT04433156|Drug|Rituximab|375 mg/m2, Intravenous administration on day 0 of each 3-week cycle until disease progression/stable disease after 2/4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.
15802162|NCT04433156|Drug|Epirubicin|70 mg/m2, Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease after 2/4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.
15802163|NCT04433156|Drug|Cyclophosphamide|750 mg/m2, Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease after 2/4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.
15802164|NCT04433156|Drug|Prednisone|100mg, oral administration on day 1 to 5 of each 3-week cycle until disease progression/stable disease after 2/4 cycles treatment or unacceptable toxicity develops, up to 6 cycles
15802165|NCT04433143|Drug|Minocycline hydrochloride capsules were taken orally|Lumenis OneTM, OPT tender system produced by American Medical Science Company; Use four of the filters. Acne filter has a wavelength of 400-600/800-1200nm. Three pulses were used for treatment, with a pulse width of 5.0ms, a pulse delay of 30ns, and an energy density of 15j /cm2. The instrument parameters were selected according to the skin lesion characteristics, age and tolerance.
15802166|NCT04433117|Biological|Shefabone|Silica-calcium phosphate composite.
15802167|NCT04433117|Biological|Bio-Oss|Xenograft Bone substitute. Bone from animals.
15802168|NCT04433104|Biological|Umbilical Cord Mesenchymal Stem Cells transplantation|Patients assigned to UC-MSC administration groups will receive two administrations at a dose of 1 million cells/kg patient body weight via the IV route with a 3-month intervening interval
15802169|NCT04433104|Drug|drug therapy according to Vietnamese MOHS procedure|Salbutamol, Terbutaline
15802170|NCT04433091|Drug|2-Hydroxybenzylamine|2-HOBA (2-Hydroxybenzlamine) 750mg will be given TID seven days prior to ablation and 28 days post ablation.
15802171|NCT04433091|Other|Placebo|Placebo will be given TID for seven days prior to ablation and 28 days post ablation.
15802172|NCT04433078|Drug|Doxycycline|100 MG Tablet
15802173|NCT04433078|Drug|Placebo|Placebo Tablet
15802175|NCT04433052|Behavioral|personalised prevention program (PPP)|Study subjects in the PPP arm will be invited to return to the study site six times over a three-year period (at V2/start of the study, V3/mo2, V4/mo6, V5/mo12, V6/mo18 and V7/mo36) to receive lifestyle coaching and exercise prescriptions led by a delegated member of the site staff and supervised by the investigator. Information on drug treatment will also be given by the investigator. These activities will be assisted by digital tools specifically designed for this study, the CoroPrevention Tool Suite.
15802176|NCT04433026|Diagnostic Test|N terminal pro B type natriuretic peptide (NTproBNP), D-Dimer, and serum Tropinin - I|Biomarkers detected in the serum of patients
15802177|NCT04433013|Drug|Lianhua Qingwen|The LHQW capsules will be administered to trial participants 4 capsules, 3 times a day, after meal
15802178|NCT04433013|Drug|Placebo|The placebo capsules will be administered to trial participants 4 capsules, 3 times a day, after meal
15802179|NCT04433000|Diagnostic Test|Butterfly|Standardized lung ultrasound scan with two different instruments
15802180|NCT04432987|Drug|Pulmozyme|"PULMOZYME contains an active substance called dornase alpha as an active substance. Dornase alpha is a human-made version of a protein called DNase in your body and is also known as recombinant human deoxyribonuclease 1 or rhDNase.
~Drug will be administered at a dose of 2,5 mg/2 times per day for 7 days"
15802181|NCT04432974|Device|Automatic closed-loop anesthesia|Total intravenous anesthesia performed with the ACTIVA automatic control system
15802182|NCT04432948|Other|PHQ-9 Depression Scale|It involves a 9-question scale that detects depression
15802183|NCT04432948|Other|GAD-7 General anxiety disorder scale|It involves a 7-question scale that detects general anxiety disorder
15802184|NCT04432948|Other|38-questions questionnaire|It involves a 38 question questionnaire that aims to detect any association between the Covid-19 pandemic, the psychological impllications and anaesthetic practice
15802185|NCT04432935|Dietary Supplement|Bovine Lactoferrin|Lactoferrin is a nutritional supplement which was first discovered in bovine milk which was later isolated in human milk as the second most abundant protein; with high levels found in colostrum. The use of bovine Lactoferrin in children is generally recognized as safe by the US Food and Drug Administration.
15802186|NCT04432935|Other|Placebo Glucon D|This group will be given 100mg Glucon-D (99.4% glucose) which will be similar in shape, color to the bLF.
15802187|NCT04432922|Other|Hospitalized Patients for COVID-19 Infection|Face to face semi-directed interviews about perceptions, representations and experiences of septic isolation, including nine opened-questions.
15802188|NCT04432909|Diagnostic Test|The level of CNV|The extracted DNA from morning urine will be analyzed by UroCAD to determine the level of CNV. And the patient will be followed for up to 2 years.
15802189|NCT04432896|Other|Dietary protocol|Dietary protocol to manage symptoms related to Systemic Nickel Allergy Syndrome.
15802190|NCT04432883|Device|Active Comparator: Experimental: Active cathodal tDCS + language training|"Cathodal tDCS raises neuronal membrane potentials, leading to decreased probability of depolarization from incoming stimuli.
~Speech and Language training involves a combined semantic feature analysis and phonological components analysis treatment."
15802196|NCT04432831|Other|Sham Procedure|The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. The sham procedure will be administered to participants as appropriate during the first 16 weeks of this study in order to maintain the masking of the initial faricimab PTI.
15802197|NCT04432818|Behavioral|Pack Health's digital life coaching (DLC)|Pack Health smartphone-based DLC platform will be provided for 16-week subscription which allows unlimited bidirectional communication between enrolled participants and their life coach
15802198|NCT04432805|Device|Performing of lung ultrasound|Performing of lung ultrasound at bedside in labor ward or in COVID unit
15802199|NCT04432792|Other|Questionnaire|Study survey participants will be administered 3 online surveys.
15802200|NCT04432779|Other|no intervention|no intervention
15802201|NCT04432766|Drug|BAT2020|After a cohort completes the study on Day 28, data on safety and tolerability for each cohort will be evaluated by the Safety Monitoring Committee (SMC). Administration of the next higher dose to a new dosing cohort will be permitted only if adequate safety and tolerability have been demonstrated. If encouraging clinical benefit is observed at a certain dose level, the study may proceed to a to Part 2 based on emerging data.
15802202|NCT04432753|Behavioral|Lung Cancer Screening Decision Aid with Incidental Findings Information|The intervention consists of a previously tested and developed brief lung cancer screening video decision aid with the addition of information on incidental findings for lung cancer screening.
15802203|NCT04432753|Behavioral|Lung Cancer Screening Decision Aid without Incidental Findings Information|The intervention consists of a previously tested and developed brief lung cancer screening video decision aid that does not include information on incidental findings.
15802204|NCT04432740|Procedure|Conservative Treatment of Distal Radius Fracture|The purpose of this prospective randomized study was to compare a new reverse sugar tong splint technique that does not immobilize the elbow with a below-arm cast, in terms of patient radiological and clinical outcomes and the ability to maintain fracture reduction.
15802205|NCT04432727|Device|Flexitouch Plus with Cellular Connectivity (FT-CC)|Daily use of FT-CC
15802206|NCT04432714|Drug|Lenalidomide|Lenalidomide 10mg/d#15mg/d#20mg/d#25mg/d d1~d10# 21days a cycle
15802207|NCT04432714|Drug|Rituximab|Rituximab 375 mg/m2，IV, d0
15802208|NCT04432714|Drug|Etoposide|Etoposide 50 mg/m2/day CI24h d1-d4
15802209|NCT04432714|Drug|Doxorubicin|Doxorubicin 10 mg/m2/day CI24h d1-d4
15802210|NCT04432714|Drug|Vincristine|Vincristine 0.4mg/m2/day CI24h d1-d4
15802211|NCT04432714|Drug|Cyclophosphamide|Cyclophosphamide 750 mg/m2/day IV d5
15802212|NCT04432714|Drug|Prednisone|Prednisone 60 mg/m2/bid oral or IV d1-d5
15802213|NCT04432701|Behavioral|proactive extubation|when children is breathing spontaneously and adequately in PACU,endotracheal tube was removed directly
15802214|NCT04432688|Drug|Lurasidone HCl|This is a non-interventional, observational study
15802215|NCT04432675|Drug|hydroxyethl starch|10 ml/kg hydroxyethl starch as well as goal-directed fluid therapy with 3ml/kg hydroxyethl starch
15802216|NCT04432675|Drug|Lactated Ringer's solution|10 ml/kg Lactated Ringer's solution as well as goal-directed fluid therapy with 3ml/kg Lactated Ringer's solution
15802217|NCT04432662|Drug|Erythropoietin|Administration of Erythropoietin (1000 U/kg) IV once a day x 5 doses along with cooling therapy
15802218|NCT04432662|Drug|Darbepoetin Alfa|Administration of Darbepoetin Alpha (10 mcg/kg) IV single dose given less than 24 hours of age along with cooling therapy.
15802219|NCT04432649|Biological|4SCAR-276|The 4SCAR-276 T cells can recognize and kill tumor cells through the recognition of CD276 .This study will evaluate the side effects and effective doses of 4SCAR-276 T cells in treating refractory and recurrent solid tumors
15802220|NCT04432636|Other|Data collection of environmental factors|- Data collection of environmental factors (including maternal nutrition and social level, mode of delivery, birth weight, mode of infant feeding, antibiotic treatments) at the recruitment
15802221|NCT04432636|Other|Collection of maternal feces|- Collection of maternal feces: the first sample after delivery and once a week during the period of hospitalization of their infant (i.e. 5 to 8 samples per mother)
15802222|NCT04432636|Other|Collection of infant feces|- Collection of infant feces: the first sample after birth and once a week during the period of hospitalization of the baby (i.e. 5 to 8 samples per mother) and a sample collected at the corrected age of 1 year and 2 years (i.e. 8 to 10 samples per infant)
15802223|NCT04432636|Other|food questionnaire|- A food questionnaire completed by the mother the week after delivery,
15802224|NCT04432636|Other|a food questionnaire on the infant alimentation and food behavior during the period of 2 and 10 months of age|a food questionnaire on the infant alimentation and food behavior during the period of 2 and 10 months of age, completed by the parents and given to the pediatrician at the medical check-up at the corrected age of 1 year
15802225|NCT04432636|Other|a food questionnaire on the infant alimentation and food behavior during the period of 12 and 24 months of age|a food questionnaire on the infant alimentation and food behavior during the period of 12 and 24 months of age, completed by the parents and given to the pediatrician at the medical check-up at the corrected age of 2 years
15802226|NCT04432636|Other|Sample of milk|A sample of 15 mL of milk drunk by the preterm at the 7th postnatal day (if not possible between the 7th and the 10th postnatal days).
15802227|NCT04432636|Other|The 'Ages and Stages Questionnaire' ASQ|- The 'Ages and Stages Questionnaire' ASQ survey completed by the parents and given to the pediatrician at the corrected age of 2 years medical check-up
15802228|NCT04432623|Drug|Benserazide Only Product|Investigational drug
15802229|NCT04432610|Drug|Bisoprolol versus Nebivolol|All subjects will receive both drugs, but at different time periods determined by randomization, with 1 week washout period
15802230|NCT04432597|Biological|PRGN-2009|On the phase I portion of the protocol PRGN-2009 will be administered on D1, D15, D29 followed by booster vaccines every 4 weeks for up to a year. The dose level given as booster will be the same dose participants will be receiving for D1, D15 and D29. On the phase II portion of the protocol PRGN-2009 will be administered on just D1 and D15.
15802253|NCT04432467|Biological|Autologous mesenchymal stem cells|Autologous adipose tissue-derived mesenchymal stem cells
15802254|NCT04432467|Other|standard treatment|standard treatment according to clinical protocols
15804559|NCT04413123|Drug|Nivolumab|Nivolumab predetermined protocol dosage via IV every 3 weeks
15802231|NCT04432597|Biological|M7824|"Subjects enrolled to Arms 1B and 2B will receive M7824 via IV infusion over 1 hour (-10 minutes / +20 minutes, that is, over 50 to 80 minutes) once every 2 weeks. M7824 will be administered as a flat dose of 1,200 mg independent of body weight. M7824 is administered as an intravenous infusion with a mandatory 0.2 micron in-line filter."
15802232|NCT04432584|Drug|Crovalimab|Crovalimab will be administered at a dose of 1000 mg IV (for participants with body weight between 40 and 100kg) or 1500 mg IV (for participants with body weight >=100kg) on Week 1 Day 1. On Week 1 Day 2 and on Weeks 2, 3 and 4, it will be administered at a dose of 340 mg SC. For Week 5 and Q4W thereafter, it will be administered at a dose of 680 mg SC (for participants with body weight between 40 and 100kg) or 1020 mg SC (for participants with body weight >=100kg). Dosing schedule will be as described above.
15802233|NCT04432584|Drug|Eculizumab|Eculizumab will be administered at a dose of 900 mg every 2 weeks, as per the dosing schedule described above.
15802234|NCT04432571|Behavioral|SOC-REC/SOC-OIC|Standard of care - routine education and counseling (SOC-REC)/SOC-Outreach and Intensified Counseling (OIC). SOC-REC is a stage 1 intervention to prevent lapses in HIV engagement through routine care. If an adolescent (1) misses an appointment >14 days, or (2) has documentation of viral load >=1000 copies/ml after >3 months of treatment he/she is re-randomized to a stage 2 intervention. SOC-OIC is a stage 2 intervention to treat lapses in HIV engagement through routine care which may include tracing and counseling to return to the clinic.
15802235|NCT04432571|Behavioral|SOC-REC/CCT|SOC-REC/Conditional Cash Transfer (CCT). SOC-REC is a stage 1 intervention to prevent lapses in HIV engagement through routine care. If an adolescent (1) misses an appointment >14 days, or (2) has documentation of viral load >=1000 copies/ml after >3 months of treatment he/she is re-randomized to a stage 2 intervention. CCT is a stage 2 intervention to treat lapses in HIV engagement by providing a small cash incentive for on-time clinic attendance and/or viral load suppression (<1000 copies/ml).
15802236|NCT04432571|Behavioral|SOC-REC/IP-NAV|SOC-REC/In-Person Peer Navigation (IP-NAV). SOC-REC is a stage 1 intervention (routine care) to prevent lapses in HIV engagement. If an adolescent (1) misses an appointment >14 days, or (2) has documentation of viral load >=1000 copies/ml after >3 months of treatment he/she is re-randomized to a stage 2 intervention. IP-NAV is a stage 2 intervention to treat lapses in HIV engagement. Trained peer navigators will develop rapport with the participants and provide psychosocial support, case management, and assess retention and adherence barriers in a systematic manner and work with the participant to develop social support and clear, feasible plans to address barriers. The peer navigator will meet with the participant at least monthly, and no more than weekly, until HIV care engagement is demonstrated.
15802237|NCT04432571|Behavioral|E-NAV/SOC-OIC|E-Nav is a stage 1 intervention to prevent lapses in HIV engagement. Trained e-peer navigators will develop rapport and provide support through phone calls and/or patient preferred social media platforms. They will meet once in person and then weekly electronically for 8 weeks, and then monthly. If an adolescent (1) misses an appointment >14 days, or (2) has documentation of viral load >=1000 copies/ml after >3 months of treatment he/she is re-randomized to a stage 2 intervention. SOC-OIC is a stage 2 intervention to treat lapses in HIV engagement through routine care which may include tracing and counseling to return to the clinic.
15802238|NCT04432571|Behavioral|E-NAV/CCT|E-Nav is a stage 1 intervention to prevent lapses in HIV engagement. Trained e-peer navigators will develop rapport and provide support through phone calls and/or patient preferred social media platforms. They will meet once in person and then weekly electronically for 8 weeks, and then monthly. If an adolescent (1) misses an appointment >14 days, or (2) has documentation of viral load >=1000 copies/ml after >3 months of treatment he/she is re-randomized to a stage 2 intervention. CCT is a stage 2 intervention to treat lapses in HIV engagement by providing a small cash incentive for on-time clinic attendance and/or viral load suppression (<1000 copies/ml).
15802239|NCT04432571|Behavioral|E-Nav/IP-NAV|E-Nav is a stage 1 intervention to prevent lapses in HIV engagement. Trained e-peer navigators will develop rapport and provide support through phone calls and/or patient preferred social media platforms. They will meet once in person and then weekly electronically for 8 weeks, and then monthly. If an adolescent (1) misses an appointment >14 days, or (2) has documentation of viral load >=1000 copies/ml after >3 months of treatment he/she is re-randomized to a stage 2 intervention. IP-NAV is a stage 2 intervention to treat lapses in HIV engagement by providing in person navigation and counseling to a cash incentive for on-time clinic attendance and/or viral load suppression (<1000 copies/ml). Trained peer navigators will provide psychosocial support, case management, and assess retention and adherence barriers in a systematic manner and work with the participant to develop social support and clear, feasible plans to address barriers
15802240|NCT04432558|Diagnostic Test|Spielberger's State-Trait Anxiety Inventory|Patients will be wanted to fill the Spielberger's State-Trait Anxiety Inventory the night before the surgery.
15802241|NCT04432558|Other|Visual analog scale, Ramsay's sedation scale|The analgesic consumption of the patients will be recorded by evaluating the pain with VAS (Visual analog scale) and sedation status with Ramsay's sedation scale in the 1st, 4th, 12th and 24th hour of postoperative period.
15802242|NCT04432558|Drug|Tramadol, paracetamol, diclofenac sodium|The analgesic consumption of the patients will be recorded
15802243|NCT04432545|Biological|Mesenchymal Stem Cells from Wharton ́s jellyintravenous infusion of Mesenchymal Stem Cells from Wharton ́s jelly|Mesenchymal Stem Cells from Wharton ́s jellyintravenous infusion of Mesenchymal Stem Cells from Wharton ́s jelly
15802244|NCT04432532|Other|No intervention|There are no interventions
15802245|NCT04432519|Procedure|Immediate dental implant placement|Dental implant insertion in the same surgical stage of the tooth extraction, consisting in implant placement in the fresh socket.
15802246|NCT04432506|Biological|Anakinra|Given SC
15802247|NCT04432506|Biological|Axicabtagene Ciloleucel|Given IV
15802248|NCT04432506|Drug|Cyclophosphamide|Given IV
15802249|NCT04432506|Drug|Fludarabine|Given IV
15802250|NCT04432493|Device|Active repetitive transcranial magnetic stimulation (rTMS)|rTMS will be used to stimulate neuronal activity of the dorsolateral prefrontal cortex (DLPFC). Participants will receive no more than 2000 pulses of rTMS at 110% of participants' resting motor threshold at 10 Hz continuously for the duration of the t-maze task.
15802251|NCT04432493|Device|Sham repetitive transcranial magnetic stimulation (rTMS)|Sham TMS will be used to mimic the auditory sensation of the Active rTMS condition. Protocols for the sham condition will be the same as the active condition, however the TMS coil will be flipped 180 degrees so that participants in this condition will not receive any active stimulation.
15802258|NCT04432428|Drug|Sufentanil Sublingual Tablet|"all patients will receive tablets for sublingual use, containing 15 microgram of sufentanil. The sufentanil tablets come in a cartridge (40 tablets) and are administered with a special patient-controlled device that uses thumb tag recognition.
~max dose per hour : 3 tablets of 15µg sufentanil"
15802259|NCT04432415|Device|Silver Diamine Fluoride|Annual application od Silver Diamine Fluoride
15802260|NCT04432415|Device|Soduim Fluoride Varnish|biannual apllication of Sodium Fluoride Varnish
15802261|NCT04432415|Device|Placebo|biannual application of artificial saliva
15802262|NCT04432402|Drug|Lenalidomide|Lenalidomide: 10mg、15mg、20mg、25mg qd PO day 1-7, Rituximab: 375 mg/m2 IV day0, Gemcitabine :1g/m2 IV day 1, oxaliplatin 100mg/m2 IV day1 (every 14 days as a cycle)
15802263|NCT04432389|Biological|ALLOB|After thawing, ALLOB® is a ready-to-use product for local administration at fracture site.
15802264|NCT04432389|Other|placebo|Placebo injected is a saline solution injectable grade (4 mL of 0.9% NaCl) filled in single-dose vial
15802265|NCT04432376|Drug|miconazole 2% oil|Drug treatment of otomycosis for 14 days
15802266|NCT04432376|Drug|vehicle oil|Placebo treatment of otomycosis for 14 days
15802267|NCT04432363|Device|Transcranial direct current stimulation|Direct current application over the scalp to stimulate and change the excitability of the cortical areas underneath the electrodes (in this case left primary motor cortex and left dorsolateral prefrontal cortex).
15802268|NCT04432337|Procedure|The role of the activation of the NLRP3 inflammasome after cardiac surgery|Determine the effect on the inflammatory response post extracorporeal circulation mediated by the NLRP3 inflammasome, in patients after cardiac surgery
15802269|NCT04432324|Biological|Intravenous Immune Globulin|IVIG Intravenous infusion
15802270|NCT04432324|Drug|Standard Medical Treatment|SMT
15802271|NCT04432311|Behavioral|Binge Focused Therapy (BFT)|The BFT group will be provided Binge Focused Therapy, a group-based, guided-self help intervention. Participants in this group will attend three online group sessions spread over six weeks (Week 1, Week 2, and Week 6) and complete homework between sessions. Following Session 3, there is a four week period where participants complete self-guided check-ins once per week to monitor continued progress and/or signs of relapse.
15802272|NCT04432311|Behavioral|CBT Unguided Self Help (CBT USH)|The CBT USH group will be provided with the book, Overcoming Binge Eating by C. Fairburn, which is a well-established self-help book used to help individuals understand binge eating and control binge eating behaviours. After participants receive the book, they will have 10 weeks to read it and work through the exercises provided in the book.
15802273|NCT04432298|Drug|Pamrevlumab|Sterile liquid for injection
15802274|NCT04432298|Drug|Placebo|Sterile liquid for injection
15802275|NCT04432285|Device|DBS-device, implanted in GPi bilaterally|Chronic/continuous bilateral GPi-DBS
15802276|NCT04432285|Drug|Botulinum toxin|Repeated intramuscular injections at regular intervals of around 3 months
15802277|NCT04432272|Biological|COVID-19 convalescent plasma|Participants will receive 1 unit of convalescent plasma procured from donors who have: 1) been symptom free for 14 days and screen negative via nasopharyngeal swab or 2) symptom free for at least 28 days or 3) individuals who have never had symptoms of COVID-19 but were found to have elevated anti-SARS-CoV-2 IgG by a serology test deemed to be of acceptable quality and fitting the current guidance by the FDA. Participants, clinicians, investigators and outcomes assessors will be blinded to the amount of anti-SARS-CoV-2 IgA and IgG present in each unit
15802278|NCT04432259|Drug|Dexamethasone|4 mg bid for 4 days
15802279|NCT04432259|Drug|Placebo|oral placebo
15802280|NCT04432246|Device|Continuous theta burst stimulation (cTBS)|50Hz of 90% MT for 3 pulses train over will be repeated at 200ms for the 40s, 600 pulses
15802281|NCT04432233|Drug|Esomeprazole|Proton pump inhibitor
15802282|NCT04432233|Drug|Metronidazole|antibiotic for H. pylori eradication
15802283|NCT04432233|Drug|Levofloxacin|antibiotic for H. pylori eradication
15802284|NCT04432220|Drug|Anticoagulation group(Apixaban group)|Apixaban 5mg twice daily (2.5mg twice daily if meets dose-reduction criteria) for 2 years
15802285|NCT04432207|Drug|IMU-201 (administered as PD1-Vaxx)|IMU-201, consists of APi2568 (lyophilized IMU-201) dissolved in WFI and emulsified with the adjuvant (Montanide ISA 720 VG) to produce PD1-Vaxx. IMU-201 will be administered as PD1-Vaxx intramuscularly into the deltoid region of the upper arm on Days 1, 15, and 29, and then on Day 64 and every subsequent 63 days until discontinuation from study.
15802286|NCT04432194|Dietary Supplement|Nutritional supplementation and Pulmonary Rehabilitation|Nutritional supplementation (HMB 4g) or Nutritional supplementation (citrulline 3g) with Pulmonary Rehabilitation
15802287|NCT04432181|Other|ophthalmic examination|ophthalmic examination including; best corrected visual acuity, alternating prism cover test, retinoscopy, fundus examination, ocular vergence evaluation
15802288|NCT04432168|Procedure|Fetoscopic Laser Surgery|Fetoscopic Photocoagulation of the connecting vascular anastomoses on the surface of the placenta.
15802289|NCT04432168|Other|Standard Treatment|"In the control group, the choices of treatment include expectant management, intrauterine transfusion (IUT) (with or without partial exchange transfusion (PET)) or preterm delivery, depending on the judgment of the fetal surgeon with regard to the gestational age and state of the disease.
~Expectant management will consist of close monitoring with ultrasound including Doppler measurements of the middle cerebral artery peak systolic velocity (MCA-PSV), at least every week.
~IUT: the intrauterine infusion of red blood cells into the circulation of the donor twin treat anemia.
~PET: the intrauterine infusion of saline into the circulation of the recipient twin to treat polycythemia.
~Preterm delivery: Induction of labor or cesarean section before 36 weeks of gestation."
15802290|NCT04432155|Drug|Xenon|30% xenon, 30% oxygen, and 40% nitrogen
15802291|NCT04432155|Drug|Placebo|30% oxygen, and 70% nitrogen
15802337|NCT04431713|Drug|Exenatide Pen Injector [Bydureon]|Exenatide is a treatment licensed for use in Type 2 diabetes.
15802338|NCT04431700|Other|Anti-inflammatory diet|Anti-inflammatory diet with increased vegetables, fruit, plant polyphenols, lean proteins, foods rich in omega-3s and unsaturated fats as well as decreased in processed refined foods.
15802339|NCT04431700|Other|Regular diet|Focus on food journal and recording all food intake.
15802340|NCT04431687|Drug|CKD 501|QD, PO
15802341|NCT04431687|Drug|D759, D150|QD, PO
15802342|NCT04431687|Drug|CKD-501, D759, D150|QD, PO
15802292|NCT04432129|Behavioral|IBBIS II|"The IBBIS-II service consists of:
~Mental health assessment.
~Planned integrated service. The participant has the same employment specialists and care manager throughout the intervention. A joint plan is made with shared decisions between the participant, the employment specialist and the care manager. There is a focus on disclosure (openness about illness) and involvement of relatives and significant others.
~Vocational rehabilitation. Focus on return to work with ongoing assessment of job goals, competencies and need of support. Participants receive help in contacting existing employers (employed) and potential employers (unemployed). Unemployed participants are offered an individualized job search effort. The focus is on competitive jobs within the community.
~Treatment consists of stepped care with structured treatment guidelines.
~When the participant has obtained work the team continues to offer support."
15802293|NCT04432129|Behavioral|Service as Usual|Service as usual consists of standard mental health care and vocational rehabilitation
15802294|NCT04432116|Behavioral|virtual reality 1|the subject is in a virtual waiting room, there is no other intervention. The principle of this intervention is to make the subject wait with as little interfering events as possible
15802295|NCT04432116|Behavioral|virtual reality 2|Subjects are in a virtual environment mimicking a space ship. On the screen there is a red light and subjects wait for this red light to become green. They press on a pad each time the red light becomes green
15802296|NCT04432103|Biological|Anti SARS-CoV 2 Convalescent Plasma in severe COVID-19 patients|Administration of Convalescent Plasma to COVID-19 obtained from donors with prior documented SARS-CoV 2 infection with IgG antibodies to hospitalized COVID-19 severe cases.
15802297|NCT04432103|Biological|Anti SARS-CoV 2 Convalescent Plasma in critical COVID-19 patients|Administration of Convalescent Plasma to COVID-19 obtained from donors with prior documented SARS-CoV 2 infection with IgG antibodies to hospitalized COVID-19 critical cases.
15802298|NCT04432090|Drug|Placebo|Each group will receive either a pill that contains the study medication (MBX-2982) or a pill that does not contain the medication (placebo)
15802299|NCT04432090|Drug|Study Medication (MBX-2982)|Each group will receive either a pill that contains the study medication (MBX-2982) or a pill that does not contain the medication (placebo)
15802300|NCT04432090|Other|No medication for this group|This group will be studied to establish the norm of the measurement that will be performed to obtain the study outcomes.
15802301|NCT04432077|Behavioral|DINO Strategies for Anxiety and fear of Uncertainty Reduction (DINOSAUR)|DINO Strategies for Anxiety and fear of Uncertainty Reduction (DINOSAUR) - a parent-mediated cognitive-behavioral treatment modified for young children with ASD
15802302|NCT04432064|Device|Active TI-NDBS|In the active TI-NDBS condition, subjects will receive stimulation for 60 minutes applied to the brain through scalp electrodes. There will be a maximum of 2 mA per electrode pair and no single region will receive more than 2 mA because the currents will be administered to distinct regions. At the beginning of each stimulation period, the current will increase slowly at a constant rate for 30 seconds until it reaches the appropriate intensity. At the end of the stimulation, the current will decrease slowly for 30 seconds until it reaches zero.
15802303|NCT04432064|Other|Sham TI-NDBS|This is the control condition in which participants will receive sham stimulation for 60 minutes.
15802304|NCT04432064|Device|tDCS|This is a well established method of brain stimulation and will be used to compare against the efficacy of TI-NDBS in the reduction of nicotine craving and inhalation. Participants will receive stimulation for 60 minutes.
15802305|NCT04432051|Behavioral|mechanical ventilator settings and position|Mechanical ventilation settings and patient position will be re-evaluated
15802306|NCT04432025|Procedure|Bariatric surgery + goal directed medical therapy|Patients will undergo bariatric surgery (RYGB or SG) with goal directed medical therapy titrated to specific end points for BP, HbA1c and lipids
15802307|NCT04432025|Procedure|Bariatric surgery|Patients will undergo bariatric surgery (RYGB or SG) with usual care for diabetes mellitus undertaken by their primary care provider/general practitioner
15802308|NCT04432012|Drug|Dexamethasone Sodium Phosphate 4 mg/ml intravenous|Perioperative intravenous injection of 3 ml of solution (9mg of dexamethasone)
15802309|NCT04432012|Drug|Dexamethasone Sodium Phosphate 4 mg/ml intra-articular|Perioperative intra-articular injection of 3 ml of solution (9mg of dexamethasone)
15802310|NCT04431999|Drug|Whole blood transfusion|Severe trauma patients with a life threatening bleeding will be managed with 3 whole blood bags for the 1st and 2nd pack. The later packs will consist of 3 packed red blood cells (PRBCs), 3 plasma units and 1 dose of platelets.
15802311|NCT04431999|Drug|Fractionated blood products transfusion|Severe trauma patients with a life threatening bleeding will be managed with 3 packed red blood cells (PRBCs), 3 lyophilised plasma units and 1 dose of platelets for the 1st. The 2nd pack will consist of 3 packed red blood cells (PRBCs) and 3 lyophilised plasma units. Then, the later pack will consist of 3 packed red blood cells (PRBCs), 3 plasma units and 1 dose of platelets.
15802312|NCT04431986|Other|No intervention: secondary use of a database|Statistical analyses
15802313|NCT04431973|Device|Medacta Shoulder System|Surgical placement of the Medacta Shoulder System prothesis on patients with pathologies requiring the insertion of a total reverse shoulder prothesis for primary omarthrosis, cuff tear arthropathy, massive cuff rupture or post instability arthropathy
15802314|NCT04431960|Drug|blackcurrant (BC) extract|A calcium citrate caplet (Bayer AG, Germany) will be taken by all 3 groups to avoid bone deterioration related to calcium and vitamin D deficiency
15802315|NCT04431934|Dietary Supplement|PROBIOTIC|"Participants assigned to the probiotic arm will receive 2 sachets of Vivomixx® dissolved in 50 L of warm water (according to the manufacturer indications) every 12 h orally or through a nasogastric tube (in this case the tube will be flushed with 50 mL of water after the administration). The probiotic will be started 24 h after the last dose of NAA and will be administered for 14 consecutive days. Each sachet of Vivomixx® contains a combination of 4 Lactobacillus (L. paracasei 24733, L. acidophilus 24735, L. delbrueckii ssp bulgaricus 24734, L. plantarum 24730), 3 Bifidobacteria (B. brief 24732, B. longum 24736, B. infantis 24737), and Streptococcus thermophilus 24731 at a concentration of 450 billion (45x1010) live lyophilized bacteria per sachet."
15802343|NCT04431674|Drug|Definity Suspension for Injection|MRI-guided ultrasound-stimulated microbubble-treatment
15802521|NCT04430257|Behavioral|Patient navigation|Ongoing PrEP navigation support to promote participants' initial and continued engagement with PrEP clinics affiliated with the two study sites
15802316|NCT04431934|Dietary Supplement|FMT REGIMEN|The FMT preparation will be administered as 2 doses, once a week, of 14-17 capsules per dose. Each dose (14-17 capsules) will contain the fecal microbiota equivalent to 50 gr of stools from a healthy donor. If the patient is carrying a nasogastric tube, the content of capsules will be decapsulized (~27 gr of powder), diluted in 50 mL of water and passed through it, followed by the administration of 50 mL of water to flush the tube. The first dose will be administered 24 h after the last dose of NAA and the second dose one week later. Whenever possible, the two doses of FMT will be originated from the same donor. According to our data done by flow cytometry and bacterial culture in three replicates, each absorbate capsule contains approximately 1.12x1010 live bacteria.
15802317|NCT04431921|Diagnostic Test|Functional capacity|Six minute walk test used assessment of functional capacity. For respiratory function mouth pressures, for cognitive functions MoCA scale and for pain assessment pain threshold and tolerance test assessed.
15802318|NCT04431908|Device|olfactory device|A quantitative non-biased olfactory device intended for the rapid identification of SARS-CoV-2 infected subjects (as identified by PCR).
15802319|NCT04431895|Drug|Tofacitinib 5 MG|tofacitinib 5 mg tablet administered twice a day for 6 months
15802320|NCT04431882|Procedure|optic nerve sheath fenestration|A standard medial transconjunctival orbitotomy was performed in all cases under general anesthesia. The medial rectus muscle was disinserted and reflected nasally with 6-0 synthetic polyester suture in typical fashion for eye muscle surgery. A traction suture was then placed through the insertion stump of the medial rectus in a baseball stitch fashion to facilitate abduction of the globe. The pupil was monitored at all times. A custom- made cupped orbital retractor was inserted along the medial scleral wall and used to retract the orbital fat and allow visualization of the optic nerve sheath. Retraction and globe abduction were relaxed if any changes in pupil size were noted. When adequate visualization was achieved, multiple dural sheath fenestrations approximately 3 mm in length. Expulsion of cerebrospinal fluid was invariably observed with the initial incision into the dural sheath.
15802321|NCT04431856|Behavioral|Unified Protocol for COVID-19 Parenting Stress (UP-COVID)|UP-COVID is a group therapy session with each session lasting approximately 60-90 minutes. The sessions will focus on cognitive and behavioral strategies for managing their own distress, anxiety and sadness related to COVID-19, as well as, strategies related to parenting in the midst of the crisis.
15802322|NCT04431856|Behavioral|SHG|Brochure that details techniques for coping with stress.
15802323|NCT04431843|Dietary Supplement|Spirulina maxima extract|once a day for 2 p.o., after breakfast and dinner(1.52 g/day, Spirulina maxima extract for 1.5 g/day) for 12 week
15802324|NCT04431843|Dietary Supplement|Placebo|once a day for 2 p.o., after breakfast and dinner(1.52 g/day, Spirulina maxima extract for 0 g/day) for 12 week
15802325|NCT04431830|Behavioral|Meaning-Centered Pain Coping Skills Training|The goal of this intervention is to help participants manage pain so that they can engage with what gives them a sense of meaning, purpose, and significance in life.
15802326|NCT04431817|Device|KinetiGait|This device is an Intel RGB depth camera that relays video to gait analysis software. The images will be taken from amputees walking at a self-selected pace on a treadmill.
15802327|NCT04431804|Other|silver nanoparticle|fungicidal effect of silver nanoparticles on aspergillus isolates
15802328|NCT04431791|Drug|Regorafenib|oral regorafenib
15802329|NCT04431791|Drug|Fruquintinib|oral fruquintinib
15802330|NCT04431778|Drug|Ethosuximide|"Taking the treatment (1 daily intake during the evening meal) according to increasing dosage:
~Step 1: 2.5 ml (125 mg) / day for 7 days Step 2: 5 ml (250 mg) / day for 7 days Step 3: 7.5 ml (375 mg) / day for 7 days Step 4 (final): 10 ml (500 mg) / day for the remainder of the study (12 weeks)."
15802331|NCT04431778|Drug|Placebo|"Taking the treatment (1 daily intake during the evening meal) according to increasing dosage:
~Step 1: 2.5 ml (125 mg) / day for 7 days Step 2: 5 ml (250 mg) / day for 7 days Step 3: 7.5 ml (375 mg) / day for 7 days Step 4 (final): 10 ml (500 mg) / day for the remainder of the study (12 weeks)."
15802332|NCT04431765|Other|Eye Movement Desensitization Reprocessing therapy|The Eye Movement Desensitization Reprocessing therapy uses bi-alternating (right-left) sensory stimulation through eye movements. The patient follows the therapist's fingers from right to left in front of his eyes and also by auditory stimuli. The patient wears a helmet that alternately makes him hear a sound to the right, then to the left or touch the patient holds in his hands buzzers that alternately vibrate from right to left, or alternatively the therapist taps the patient's knees or the back of his hands.
15802333|NCT04431765|Behavioral|Trauma-Centred Cognitive and Behavioural Therapy|A CBT is a short, scientifically validated therapy that focuses on the interactions between thoughts, emotions and behaviours. These therapies focus on the current problems of the person, while taking into account their historical causes. They help gradually overcome disabling symptoms and aim to strengthen adaptive behaviours. A CBT relies on different techniques that help the patient to identify the mechanisms at the origin of his difficulties, to experiment with new behaviors and thus to gradually come out of vicious circles that perpetuate and aggravate the psychic suffering.
15802334|NCT04431752|Radiation|Magnetic Resonance Imaging Scan|The selection of patients with different level of OA will be made using the existing Kellgren-Laurence grading systems. The recruited patients will receive MRI exams with our enhanced sequencing. The OA level of each patient will be determined objectively through our quantitative OA grading system on MRI, which will be compared to Kellgren-Laurence grading results to evaluate the clinical performance of the MRI.
15802335|NCT04431739|Device|MRI including conventional MRI, DWI with multiple ADC values|The utility of apparent diffusion coefficient obtained in diffusion-weighted MR imaging for the differentiation between benign and malignant vertebral lesions
15802344|NCT04431661|Procedure|Optical Coherence Tomography|OCT (DragonFly, Abbott Vascular) will be performed after angiography. OCT images will be acquired using the 6F guide catheter compatible DragonFly System (Abbott Vascular, Santa Clara, USA). The catheter will be introduced into the first coronary artery via a standard 0.014-inch angioplasty wire, after prior injection of an intracoronary bolus of nitro-glycerine (according to the hemodynamic conditions of the patient). To remove all blood adequately from the imaging site, nonocclusive flushing will be performed using continuously inject via an automated power injector, and the OCT catheter will be pulled back at a speed of 18 mm/second to guarantee sufficient time to acquire images of a 54 mm long segment (frame density: 10 frames/mm).
15802345|NCT04431661|Procedure|Coronary Angiography|The coronary angiography will be performed according to the strategies described in the consensus statement from the European Association for Percutaneous Cardiovascular Interventions (EAPCI)/Stent for Life (SFL) groups.Transradial or transfemoral 6F/7F approaches are recommended. The choice of diagnostic catheters, guiding catheters, guidewires, pre-dilatation, atherectomy devices, and post dilatation is let to the investigator's discretion.
15802346|NCT04431661|Procedure|Per cutaneous coronary intervention|Based on coronary angiography and OCT analyses by the investigators, PCI will be performed, preferentially for the identified culprit lesion(s) only. The guiding catheters, guidewires, pre-dilatation, atherectomy devices, and post dilatation are left to physician discretion. The use of semi- or non-compliant balloons number and diameter of drug eluting stent(s) will also be left to the physician discretion, but post dilation will be strongly recommended in case of PCI. OCT can eventually be performed after stent implantation to guide, post dilation strategy.
15802347|NCT04431648|Drug|Definity Suspension for Injection|MRI-guided ultrasound-stimulated microbubble-treatment
15802351|NCT04431622|Device|Hearing aid amplification algorithms|The investigators will use stimulus waveforms that have been amplified and recorded for each individual's hearing loss. These waveforms will be created using Desired Sensation Level, Version 5-C hearing aid targets on a continuum of increased signal manipulation. The NIH-funded open hearing aid platform will be used to provide precise control over hearing aid parameters to create waveforms with linear and fast-acting compression amplification. A third set of waveforms will be created using a current clinical hearing aid that uses typical noise reduction and compression parameters. Investigating the effects of hearing aid algorithms in young normal-hearing and older normal-hearing listeners will aid in interpretation of these effects in the older hearing-impaired listeners.
15802352|NCT04431596|Device|Forearm cooling|forearm immersion will be performed for active cooling assessment.
15802353|NCT04431596|Other|Mist-fan cooling|A mist-fan will be placed in front of the participant for active cooling.
15802354|NCT04431583|Procedure|Bariatric surgery- single surgeon service|
15802355|NCT04431583|Procedure|Bariatric surgery- multiple surgeon + multidisciplinary team approach|
15802356|NCT04431583|Procedure|Bariatric surgery: formalized streamlined multiple surgeon + multidisciplinary team approach|
15802357|NCT04431570|Device|rTMS|The device is made in London, United Kingdom
15802358|NCT04431570|Device|sham stimulation|the device of sham stimulation was MagStim MC-P-B70 placebo butterfly coil
15802359|NCT04431544|Device|AcQMap System|To evaluate procedural and long-term outcomes when using the diagnostic AcQMap System as an imaging and mapping system for ablation of arrhythmias in accordance with the Instructions for Use (IFU).
15802360|NCT04431531|Other|10 Sessions of yogatherapy associate with EMDR|The first group will have Yogatherapy plus EMDR treatment
15802361|NCT04431531|Other|The second group will have EMDR without yogatherapy|the second one will have EMDR treatment
15802362|NCT04431518|Drug|JULUCA 50Mg-25Mg Tablet|One dose of JULUCA will be taken daily for up to 14 days
15802363|NCT04431505|Other|apoptosis|study of apoptotic changes due to anaesthesia
15802364|NCT04431492|Procedure|CABG|aminoacids and NO levels
15802365|NCT04431479|Procedure|Biospecimen Collection|Undergo collection of blood sample
15802366|NCT04431479|Other|Medical Chart Review|Review of medical chart
15802367|NCT04431479|Other|Quality-of-Life Assessment|Ancillary studies
15802368|NCT04431479|Other|Questionnaire Administration|Complete questionnaire
15802369|NCT04431466|Drug|Ivermectin|SOC plus different dosing regimens of Ivermectin
15802370|NCT04431466|Other|Standard of Care|Standard treatment for COVID-19
15802372|NCT04431440|Other|silver nanoparticles|effect silver nanoparticles will be examined on multidrug resistant bacteria
15802373|NCT04431427|Device|Biliary drainage with PC-SEMS|partially covered metallic biliary stent insertion during ERCP
15802374|NCT04431427|Device|Biliary drainage with U-SEMS|Uncovered metallic biliary stent insertion during ERCP
15802375|NCT04431414|Other|Sample collection|"blood, nasal swab, nasal wash, and saliva
~optional stool swab"
15802376|NCT04431401|Device|Magstim rTMS|The device is made in London,UK
15802377|NCT04431388|Device|ultrasound device|We performe a differnt analgesic techniques to know if some of then are better
15802378|NCT04431388|Drug|Levobupivacaine|using the same AL
15802379|NCT04431375|Biological|Plasma Exchange|Plasma exchange 2 sessions alternate day followed by FMT for 7 days and Tenofovir [antiviral] 300mg PO once a day .
15802380|NCT04431375|Drug|Tenofovir|Tenofovir [antiviral] 300mg PO once a day .
15802381|NCT04431375|Other|Fecal Mircobiota Transplantation|FMT for 7 days
15802382|NCT04431362|Behavioral|Self-selected music|Participants will be given iPods and headphones to listen to their music
15802383|NCT04431349|Drug|Ticagrelor 180mg|Patient received loading dose of ticagrelor for coronary angiography within 2 days prior to OPCAB or CABG.
15802384|NCT04431349|Drug|Clopidogrel 75mg|Patient received loading dose of clopidogrel for coronary angiography within 2 days prior to OPCAB or CABG.
15802385|NCT04431336|Behavioral|movement|movement
15802410|NCT04431050|Diagnostic Test|Point of care testing of respiratory viruses.|Single use point of care diagnostic device.
15804560|NCT04413123|Drug|Ipilimumab|Ipilimumab predetermined protocol dosage via IV every 3 weeks
15802386|NCT04431323|Behavioral|ESPRIMO|"Participants will receive the intervention during Phase 2.
~The intervention is based on the cognitive behavioral, the third-wave (mindfulness and acceptance and commitment therapy), and the positive psychology approach.
~The frequency of the intervention and the specific content and aims of the psychological and physical intervention will be based on the results of the surveys and the focus group discussion (Pre-phase and Phase 1). In order to maximize the benefit of the integrated intervention, all the three components of the interventions (i.e., psychological, motor exercise and social components) will be administered in the same time period.
~A preliminary theoretical framework of the intervention will be created prior to the survey phase according to the literature in the field. Specific aspects of this preliminary framework will be discussed during the co-creation phase and adapted after the analysis of the qualitative results."
15802387|NCT04431310|Other|Serial seroconversion measurements in hospital employees during the COVID-19 pandemic|The aim of this study is to apply serology testing methods for SARS-CoV2 antibodies in samples collected from HCWs in an acute hospital.
15802388|NCT04431297|Other|Mindfulness Rounds|Virtually delivered mindfulness education sessions of 15-30 minutes, two times/week, for four weeks
15802389|NCT04431284|Other|Questionnaires|The two groups (23 patients per group) will be contacted by phone or e-mail to participate to the CIO study. Once their agreement received, each patient will be asked to complete the same set of online questionnaires : weight, HAD (Hospital Anxiety and Depression scale), BES (Binge Eating Scale), YFAS (Yale Food Addiction Scale), DEBQ (Dutch Eating Behavior Questionnaire), IPAQ (International physical activity questionnaire), COVID 19 questionnaire Penn State, items from the Do-It questionnaire, general questions on the lifestyle during the lockdown (custom questionnaire), COVID stress evaluation (custom questionnaire)
15802390|NCT04431271|Procedure|Robot-assisted hernia repair|Inguinal hernia repair was performed using the DaVinci Xi robotic system
15802391|NCT04431258|Drug|ABTL0812|ABTL0812 will be administered daily at its RP2D. ABTL0812 will be administered as single agent during a run-in period of one week before starting the first cycle of FOLFIRINOX, then daily during chemotherapy cycles. Also, ABTL0812 will be maintained once chemotherapy is discontinued, if ABTL0812 is tolerated and if the patient is in response or stable disease.
15802392|NCT04431258|Drug|Folfirinox|"FOLFIRINOX will be dosed according to the standard following regimen:
~oxaliplatin 85 mg/m2, administered as 2-hour iv infusion, followed by
~irinotecan 180 mg/m2, administered as 1.5-hour iv infusion, followed by
~fluorouracil 2400 mg/m2, administered as 46-hour iv infusion every 2 weeks (=1 cycle) until disease progression or unacceptable toxicities."
15802393|NCT04431258|Drug|Placebo|Placebo will be administered daily at the same regim as ABTL0812. Placebo will be administered as single agent during a run-in period of one week before starting the first cycle of FOLFIRINOX, then daily during chemotherapy cycles. Also, placebo will be maintained once chemotherapy is discontinued, if the patient is in response or stable disease.
15802394|NCT04431245|Drug|Entecavir|Study subjects will stop the antiviral therapy. Patients will be closely monitored every 6-8 weeks for virological flare and/or biochemical flare.
15802395|NCT04431232|Device|Endoscopic Band Ligation|Band ligation of the gastric body for weight loss
15802397|NCT04431206|Drug|Oxytocin|Oxytocin administered by IV infusion
15802398|NCT04431193|Drug|Oxytocin|Oxytocin infused to maintain serum concentrations of 4, 16, 64, and 256 picogram/millilitre
15802399|NCT04431180|Behavioral|blood donation SMS|The literature shows that the information extraction and processing in emergency is different from the normal situation. To find the most effective emergency recruitment method during an outbreak, we intervened with a well-balanced group of donors by presenting different emergency recruitment text messages.
15802400|NCT04431167|Behavioral|Living well with Lupus|The lifestyle change intervention will involve two constructs: increasing the level of physical activity and improving eating habits, each with its own specific domains and goals. It will be based on a structured program of physical exercises and selection of individualized goals in the domains of transportation, leisure and work to reduce sedentary behavior with the aim of increasing the level of physical activity, as well as establishing changes in dietary aspects, involving consumption domains, structure, behavior and eating attitude using nutritional counseling techniques.
15802401|NCT04431154|Behavioral|Provision of HIV self-screen kit with incentives and linkage promotion|This arm will receive a HIV self-screen kit and additional incentives to promote adherence and linkage to care
15802402|NCT04431141|Drug|Teneligliptin|Teneligliptin alone
15802403|NCT04431141|Drug|Empagliflozin|Empagliflozin alone
15802404|NCT04431141|Drug|Teneligliptin and Empagliflozin|Teneligliptin and empagliflozin
15802405|NCT04431128|Behavioral|infant feeding position|correlation with allergy, GER or feeding position
15802406|NCT04431115|Other|Interviews|Interviews for stakeholders
15802407|NCT04431102|Other|PILATES METHOD|"It is intended that the Pilates program have a duration of four weeks and its realization does not suppose an excessive consumption of resources. Therefore, it must have a series of characteristics: low supervision and easily realizable by all patients, which implies flexibility in the schedule. In this sense the sessions of Pilates is adjusted to these assumptions and the Pilates monitor offers several schedules on diferent days of week.
~The pregnant women assigned to the intervention group will be supervised by the midwifery of reference and trained by a Pilates monitor who will explain the training program and resolve the doubts raised by the women.
~The therapeutic control will be carried out by telephone call and clinical history review between the eighth and tenth day."
15802408|NCT04431089|Drug|SHC014748M|Each treatment cycle is comprised of 28-day consecutive dosing of SHC014748M, 200mg QD (Days 1 to28). Upon completion of each cycle, patients may continue to receive oral SHC014748M if they can benefit from the treatment and the toxicity is tolerable.
15802409|NCT04431063|Procedure|Distal Stump Suturing|in ACL Reconstruction case , Group A consist of subject with operation procedure suturing the distal stump peroneus longus against the peroneus brevis in ACL reconstruction using the peroneus longus autograft.
15802411|NCT04431037|Dietary Supplement|Early oral feeding/Enhanced recovery after surgery protocols|Early oral feeding refers to NG tube and foley's catheter removed within 12 hours and patients allowed oral sips on day 1 with gradual shift to liquid diet after 12 hrs and semisolid food started after 24 hours later.Patients were given i/v antibiotics,painkillers and i/v PPIs and shifted to oral pain killers on 2nd POD.
15802412|NCT04430998|Drug|Zinc L-Carnosine|Undiluted 10 ml of Zinc L-Carnosine mouth rinse, retain for 3 minutes, 3 times daily
15802413|NCT04430998|Drug|Chlorhexidine|Undiluted 10 ml of Chlorhexidine mouth rinse, retain for 3 minutes, 3 times daily
15802414|NCT04430998|Other|Water|Rinse mouth with 10 ml of water, retain for 3 minutes, 3 times daily
15802420|NCT04430972|Procedure|Aortic valve replacement|Open surgical replacement of aortic valve
15802421|NCT04430959|Drug|Candesartan|Candesartan 4 mg, tablets, orally, once daily for 4 weeks
15802422|NCT04430959|Drug|Placebo|Candesartan placebo-matching tablets, orally, once daily for 4 weeks
15802423|NCT04430946|Diagnostic Test|Standardized test meal|A test meal of ~700 kcal consisting of protein and fat will be consumed within 10 minutes
15802424|NCT04430933|Drug|NC318|NC318 is an experimental antibody drug that will be administered by IV infusion on the first day of each 21 day cycle
15802425|NCT04430933|Drug|Pemetrexed/Carboplatin|Pemetrexed/Carboplatin will be administered per the approved respective product label following the infusion of NC318 on the first day of each 21 day cycle
15802426|NCT04430933|Drug|Nab paclitaxel/Carboplatin|Nab-paclitaxel/Carboplatin will be administered per the approved respective product label following the infusion of NC318 on the first day of each 21 day cycle
15802427|NCT04430933|Drug|Docetaxel|Docetaxel will be administered per the approved product label following the infusion of NC318 on the first day of each 21 day cycle
15802428|NCT04430920|Other|Intensive intraoperative blood pressure management|Targeting intraoperative mean arterial pressure ≥ 80 mmHg.
15802429|NCT04430920|Other|Conventional intraoperative blood pressure management|Targeting intraoperative mean arterial pressure ≥ 65 mmHg or 60% of the baseline level (use the higher target).
15802430|NCT04430907|Biological|HPV 9-valent Vaccine, Recombinant|"After consent, participants will complete an intake survey confirming eligibility. Participants will also complete a survey asking about knowledge, attitudes, and beliefs around vaccination, including HPV vaccination, as well as breastfeeding intentions.
~After survey completion, the participant will be asked if they would like to be administered the HPV vaccine, Gardasil 9. If participants do not agree, they will be contacted 1-week later for the follow-up survey. If participants do agree, the project coordinator will notify the study physician, who will place an order for the vaccine. The vaccine will be administered to the patient prior to discharge from the hospital. Participants will be contacted 1-week later for the follow-up survey."
15802431|NCT04430894|Drug|Carfilzomib|"Induction: protocol determine dose,via IV on 3 days per cycle up to 8 cycles, dependent on Upfront Stem Transplant or Deferring Stem Cell Transplant determination
~Maintenance: protocol determine dose,via IV on 2 days per cycle- Maintenance Cycle until progressive disease (PD) or unacceptable toxicity"
15802432|NCT04430894|Drug|Isatuximab|"Induction: At predetermined dose, via IV up to 8 cycles, dependent on Upfront Stem Transplant or Deferring Stem Cell Transplant determination:
~-- Cycles 1 and 2 once per week, Cycles 3-4 every other week, Cycles 5 and 6 every other week, Cycles 7 and 8 once every 4 weeks.
~Maintenance: At predetermined dose, via IV, once per cycle, Maintenance Cycle until progressive disease (PD) or unacceptable toxicity"
15802433|NCT04430894|Drug|Lenalidomide|- Induction Predetermined Dose, oral, days 1-21 of up to 8 cycles, dependent on Upfront Stem Transplant or Deferring Stem Cell Transplant determination Maintenance: At predetermined dose, oral days 1-21 per cycle until progressive disease (PD) or unacceptable toxicity
15802434|NCT04430894|Drug|Dexamethasone|Induction: Predetermined dosage, oral, Predetermined times per cycle up to 8 cycles dependent on Upfront Stem Transplant or Deferring Stem Cell Transplant determination Maintenance: orally or IV will be administered as a preinfusion medication prior to isatuximab dosing
15802435|NCT04430868|Behavioral|lifestyle redesign program|In this group, it starts with health education, the participants then change their opinions and experience health activities, and it ends with discussion and sharing their experience.
15802436|NCT04430855|Drug|Upadacitinib|Tablet; Oral
15802437|NCT04430855|Drug|Placebo Upadacitinib|Tablet; Oral
15802438|NCT04430842|Drug|QBS10072S|QBS10072S targets cancers with high LAT1 expression.
15802439|NCT04430829|Diagnostic Test|Weight-Bearing CT arthrography|A 20ml mixture of 5ml 0.5% ropivacaine, 5ml preservative-free sterile saline, and 10ml of non-ionic iodinated contrast media (e.g. iohexol 240) will be instilled into the knee joint of each patient prior to WBCTa imaging of the knee (LineUp, CurveBeam, LLC).
15802440|NCT04430816|Procedure|double mesh modification of chevrel's technique|repair of midline incisional hernia by double mesh modification of chevrel's technique
15802441|NCT04430816|Procedure|on lay mesh hernioplasty|repair of midline incisional hernia by online mesh hernioplasty
15802442|NCT04430803|Dietary Supplement|Hydrogen-rich water|A tablet that produces hydrogen dissolved in a glass of water
15802443|NCT04430803|Other|Control Water|A glass of tap water
15802444|NCT04430790|Drug|Doxapram|Loading dose and continuous doxapram infusion.
15802445|NCT04430790|Drug|Placebo|Loading dose and continuous placebo infusion.
15802446|NCT04430777|Drug|Tranexamic acid|Administration of tranexamic acid 1 gr either intravenously or subcutaneously
15802447|NCT04430764|Procedure|non-surgical periodontal treatment|Non-surgical periodontal treatment program was as following: First, motivation and oral hygiene instructions were given to all participants with periodontitis. The modified-Bass tooth brushing technique with a given dentifrice and toothbrush twice a day, and dental flossing/ interdental brushing once a day was advised to all patients with periodontitis. Second, scaling using an ultrasonic device and root planning by hand instruments under local anesthesia was performed.
15802448|NCT04430751|Behavioral|Medical QiGong training|"The study intervention consisted of a 12-week training program that introduced students to a progressive series of 10 QiGong forms that are designed to build upon each other to restore balance and function and to enhance well-being. These forms involve both physical movement and visualization."
15802449|NCT04430738|Drug|tucatinib|For Cohort 1A, 150 mg will be administered twice daily by mouth (orally) from Cycle 1 Day 8 onwards. For all other cohorts, 300 mg (or intermediate dose) will be given orally twice daily starting on Cycle 1 Day 1.
15802450|NCT04430738|Drug|trastuzumab|Cohorts 1A and 1B: a 6 mg/kg loading dose will be given into the vein (IV; intravenously) on Cycle 1 Day 1, followed by a dose of 4 mg/kg IV every 2 weeks starting on Cycle 2 Day 1. Cohorts 1C, 1D, 1E, 1F, 1G, 2A, and 2B: an 8 mg/kg loading dose will be administered IV on Cycle 1 Day 1, followed by a dose of 6 mg/kg IV every 3 weeks thereafter.
15802451|NCT04430738|Drug|oxaliplatin|85 mg/m^2 given IV every 2 weeks for cohorts using FOLFOX. For cohorts using CAPOX regimen, 130 mg/m^2 given every 3 weeks.
15802452|NCT04430738|Drug|leucovorin|200 (mFOLFOX7) or 400 (mFOLFOX6) mg/m^2 given IV every 2 weeks. Part of FOLFOX regimen.
15802453|NCT04430738|Drug|fluorouracil|400 mg/m^2 (IV bolus after leucovorin) and/or 2400 mg/m^2 (continuous infusion over 46 hours). Part of FOLFOX regimen.
15802454|NCT04430738|Drug|capecitabine|1000 mg/m^2 is taken twice per day orally on Days 1-14 of each 3 week cycle. Part of CAPOX regimen.
15802455|NCT04430738|Drug|pembrolizumab|400 mg given by IV on day 1 of cycle 1, then every 6 weeks.
15802456|NCT04430725|Procedure|Computed Tomography with Contrast|Undergo contrast-enhanced CT
15802457|NCT04430725|Procedure|Microwave Ablation|Undergo microwave ablation
15802458|NCT04430725|Other|Questionnaire Administration|Ancillary studies
15802459|NCT04430725|Procedure|Wedge Excision|Undergo wedge resection
15802460|NCT04430699|Drug|Cisplatin|Participants will be given Cisplatin by intravenous infusion at a predetermined dose 1x weekly up to 8 weeks.
15802461|NCT04430699|Drug|Pembrolizumab|Participants will be given Pembrolizumab by intravenous infusion at a predetermined dose 1x every 3 weeks up to 36 weeks.
15802462|NCT04430699|Radiation|Radiation Therapy|Standard of care radiation therapy 1x daily up to 8 weeks.
15802463|NCT04430686|Other|Questionaires|Any validated functional rating scale, such as the Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS) or the ALSFRS-Revised (if available)
15802464|NCT04430673|Other|Home-School based VR system trial|Commercially available VR games operated Raspberry pi micro computer and Oculus Quest VR headsets provided for 2 weeks at dose and intensity selected by participants.
15802465|NCT04430660|Other|13C-MRS procedure/Acetate infusion|Glial metabolism will be measured via MRS utilizing a simultaneous intravenous infusion of 13C labeled acetate. An intravenous catheter will be placed in a vein of each arm, one to infuse 13C-acetate and the other to draw blood samples.
15802466|NCT04430660|Device|Continuous glucose monitoring|Participants will wear blinded continuous glucose monitoring devices (dexcom, G6) for approximately 4 weeks. Sensors will be replaced every 7-10 days.
15802467|NCT04430647|Procedure|combined phacoemulsification and ultrasound ciliary plasty (Phaco-UCP)|performing ultrasound ciliary plasty then performing standard phacoemulsification
15802468|NCT04430647|Procedure|Phacoemulsification alone|standard phacoemulsification for catarct extraction
15802469|NCT04430634|Other|Myblu variant A|Use of Myblu e-cigarette with flavor A 2.4% nicotine
15802470|NCT04430634|Other|Myblu variant B|Use of Myblu e-cigarette with flavor B 3.6% nicotine
15802471|NCT04430634|Other|Myblu variant C|Use of Myblu e-cigarette with flavor C 2.5% nicotine
15802472|NCT04430634|Other|Myblu variant D|Use of Myblu e-cigarette with flavor D 4.0% nicotine
15802473|NCT04430634|Other|Myblu variant E|Use of Myblu e-cigarette with flavor E 3.6% nicotine
15802474|NCT04430634|Other|Myblu variant F|Use of Myblu e-cigarette with flavor F 2.4% nicotine
15802475|NCT04430634|Other|Myblu variant G|Use of Myblu e-cigarette with flavor G 4.0% nicotine
15802476|NCT04430634|Other|Myblu variant H|Use of Myblu e-cigarette with flavor H 3.6% nicotine
15802477|NCT04430621|Drug|Follicle Stimulating Hormone|FSH will be administered s.c. in the morning to male healthy subjects
15802478|NCT04430608|Device|Dexcom G6|"The investigational device is a CGM Dexcom G6. The Dexcom G6 System is intended to replace fingerstick blood glucose testing for diabetes treatment decisions. The device-system consists of a sensor, the Dexcom G6 device/sender, and connects to a smart device like a cellphone. The Dexcom G6 CGM system is probably the most precise system on the market and with no need for daily calibration with finger prick glucose. The Dexcom G6 sensor can last for 10 days without calibration and is approved for diabetes treatment decision making. Dexcom G6 has been extensively tested and is safe and approved even for pregnant women.
~The CE Marking confirms that the G6 system meets the Essential Requirements of the Medical Device Directive MDD 93/42/EEC as amended by 2007/47/EC."
15802479|NCT04430595|Biological|4SCAR T cells|Infusion of 4SCAR-GD2, -Her2 and -CD44v6 CAR-T cells
15802480|NCT04430582|Other|Cognitive Assessment (not diagnostic)|Cognitive testing will assess working memory and attention, verbal memory and delayed memory, executive function, and psychomotor speed.
15802481|NCT04430582|Diagnostic Test|ECG|ECG will take place during screening visit.
15802482|NCT04430569|Drug|Alteplase|Alteplase single intravenous infusion of 0.6 mg/kg of estimated bodyweight with a maximum of 50 mg given over 15 minutes.
15802483|NCT04430569|Drug|Placebo|Placebo single intravenous infusion of 0.6 mg/kg of estimated bodyweight with a maximum of 50 mg given over 15 minutes.
15802484|NCT04430556|Drug|Sertraline|Sertraline will be started in all patients, unless it is contraindicated, in this case, Escitalopram will be indicated.
15802485|NCT04430543|Behavioral|Cognitive Bias Modification|"CBM sessions are computer tasks that take 15 minutes each. CBM is similar to an alcohol approach avoidance task (AAT) in that they will involve moving their mouse forward to simulate an avoidance/push response and backward to simulate an approach/pull response in response to alcohol and neutral stimuli depending on photograph orientation. Photos will get larger as if coming toward the participant when pulled and will get smaller as if moving away when pushed. CBM will involve pushing 90% of alcohol stimuli (pulling 10%) and pulling 90% of neutral stimuli (pushing 10%)."
15802520|NCT04430257|Behavioral|Problem-solving and planning|Bachelors-level PrEP Navigators will assist participants with problem-solving and planning.
15804621|NCT04412668|Drug|Placebo|Placebo administered intravenously
15802486|NCT04430543|Behavioral|Sham Training|"Sham training sessions are computer tasks that take 15 minutes each. Sham training is similar to an alcohol approach avoidance task (AAT) in that they will involve moving their mouse forward to simulate an avoidance/push response and backward to simulate an approach/pull response in response to alcohol and neutral stimuli depending on photograph orientation. Photos will get larger as if coming toward the participant when pulled and will get smaller as if moving away when pushed. Sham training will involve pushing and pulling 50% of each type of stimuli (alcohol and neutral)"
15802487|NCT04430530|Biological|Infusion of 4SCAR-T specific to CD22/CD123/CD38/ CD10/CD20|Patients who have relapsed after anti-CD19 immunotherapy or have CD19 negative B cell malignancies
15802489|NCT04430504|Behavioral|multidisciplinary telerehabilitation|weekly video meetings to instruct and monitor self-exercises at home
15802490|NCT04430491|Diagnostic Test|radiomics|The high-throughput extraction of large amounts of quantitative image features from medical images
15802491|NCT04430478|Diagnostic Test|Volume flow guided angioplasty|Volume flow measurements using DUS will be obtained at the end of each balloon dilation, at 24 hours, 6 months, and one year after index procedure.
15802492|NCT04430465|Dietary Supplement|Grain products high in wholegrains from oat and rye|A selection of grainproducts high in wholegrain from oat and rye, including cereals, bread, rolls, and pasta is replacing habitual grain products
15802493|NCT04430465|Dietary Supplement|Grain products low in wholegrains|A selection of grainproducts low in wholegrain, including cereals, bread, rolls, and pasta is replacing habitual grain products
15802494|NCT04430452|Biological|Durvalumab|Given IV
15802495|NCT04430452|Radiation|Hypofractionated Radiation Therapy|Undergo hypofractionated RT
15802496|NCT04430452|Biological|Tremelimumab|Given IV
15802497|NCT04430439|Behavioral|Psychosocial stress|The TSST is a 15 minute standardized lab-based challenge task that involves speech preparation, speech delivery while being evaluated by strangers and video taped, and complex mental arithmetic with critiques if errors are made.
15802498|NCT04430439|Behavioral|Control non-stress|Participants will have a relaxed 15 minute conversation with a familiar research team member.
15802499|NCT04430426|Other|Controlled Diet|Participants will consume a controlled low oxalate diet for five days.
15802500|NCT04430426|Other|Glycolate Administration|Participants will come to the UAB Clinical Research Unit (CRU) and be administered a glycolate load via intravenous (IV) catheter.
15802501|NCT04430413|Biological|Platelet Rich Plasma|Autologous PRP obtained via double centrifugation process of the participant's blood sample. PRP was prepared by the double Spain strategy.
15802505|NCT04430374|Other|No interverntion|No intervention will be done, registry only
15802506|NCT04430361|Drug|Megestrol|160 mg of megestrol acetate dispersible tablets were taken orally every morning on the day of the beginning of chemotherapy for 10 days.
15802507|NCT04430361|Drug|5-HT3 receptor antagonist|5-HT3 receptor antagonist 2.5mg/iv
15802508|NCT04430361|Drug|dexamethasone|dexamethasone 12mg on the first day, 8mg on the 2nd-4th day,
15802510|NCT04430335|Behavioral|Telephone interview|Interested participants will complete a telephone interview to determine eligibility for the study. If found to be eligible for the study, participants will be registered and set up a time to speak with an assigned study coach.
15802511|NCT04430335|Behavioral|Cognitive Behavioral Therapy|Participants will speak with their assigned coach over the phone for 12 weeks to discuss the cognitive behavioral therapy (CBT) study workbook and provide feedback. CBT is a type of treatment that teaches people different ways to handle anxiety and/or depressive symptoms, such as by relaxing the body, changing thoughts, and solving problems. Participants will receive a workbook focused on teaching these strategies.
15802512|NCT04430309|Behavioral|Baduanjin exercise program|The sessions includes 10-minute warm-up, 40-minute Baduanjin exercise and 10-minute cool down.
15802513|NCT04430309|Behavioral|Brisk walking program|The sessions includes 10-minute warm-up, 40-minute brisk walking and 10-minute cool down.
15802514|NCT04430296|Procedure|Cyclophotocoagulation|"High Intensity Focused Ultrasound Cyclophotocoagulation (HIFU): parameters: 21 MHz frequency, 2.45 W acoustic power, with the activation of each transducer lasting 6 seconds MicroPulse cyclophotocoagulation (MP-CPC):Laser settings of 2 Watts (W) will be applied for a 90 seconds treatment time for each 180 degrees, with a duty cycle of 31.3%, which consists of 0.5ms on time and 1.1 ms off-time and delivering a total of 112,7 Joules Continuous Wave cyclophotocoagulation (CW-CPC): The laser settings used will be 1.250 W, 4s exposure time per burn, 22-24 burns per eye."
15802517|NCT04430270|Behavioral|Survey|Sequential Assignment
15802518|NCT04430257|Other|HIV and PrEP education|Navigators will deliver Social Cognitive Theory-informed HIV and PrEP education.
15802519|NCT04430257|Behavioral|Motivational interviewing|Bachelors-level PrEP Navigators who are trained in motivational interviewing (MI) will use MI to promote the behavioral intervention.
15802522|NCT04430257|Other|PrEP information|A brief video that describes what PrEP is and how it works to prevent HIV via sexual and injection transmission will be shown to participants.
15802523|NCT04430257|Other|Referrals|Study staff will provide basic information about PrEP and referrals to PrEP clinicians.
15802524|NCT04430244|Procedure|Deep anterior lamellar keratoplasty|Deep anterior lamellar keratoplasty using dehydrated corneas
15802525|NCT04430244|Procedure|Deep anterior lamellar keratoplasty|Deep anterior lamellar keratoplasty using standard organ culture stored corneas
15802526|NCT04430231|Other|Wait list time|
15802527|NCT04430218|Device|iSens|The study involves a surgical implant of cuff electrodes on the nerves in the amputated limb, and muscle recording electrodes the remaining muscles. These will be connected to an implanted stimulator. The stimulator will connect wirelessly to an advanced prosthesis. This may allow a user to move the prosthetic hand intuitively and feel what your prosthesis is touching.
15802528|NCT04430205|Procedure|Adhesive restoration protocol|"The canal walls were etched with 37% orthophosphoric acid for 30 seconds with use of a microbrush.
~The primer was applied on the wet canal walls, with a microbrush several times, after checking by drying the canal, that the appearance of the dentine was shiny and not opaque or chalky.
~The next step was the application of bonding with a microbrush, blowing in the fracture line to make sure it is not loaded with bonding.
~Flow composite was used to make it penetrate the fracture line with the help of a 0.06 mm k-file.
~The canals were filled with dual composite parts more deeply, light cured at the canal entrance and pulp chamber; the following phase was the coronal restoration with a sandwich technique, covering the cusp with composite."
15802529|NCT04430192|Drug|177Lu-PSMA-617|Patients 1-10 will be given 5GBq of 177Lu-PSMA. Patients 11-20 will be given 2 cycles of 5GBq of 177Lu-PSMA, separated by 6 weeks.
15802530|NCT04430179|Drug|Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]|300 mg every other week for 24 weeks
15802531|NCT04430179|Other|Placebo|No active drug
15802532|NCT04430166|Drug|PD-1 monoclonal antibody|200mg / intravenous drip, once every three weeks
15802533|NCT04430153|Other|"Class 1 Medical Device CE certified devices: ActiGraph wGT3X-BT accelerometer"|Accelerometers on both patients' wrists will give insight into the daily life upper limb use.
15802534|NCT04430140|Device|CT Scan|"CT Scan
~Number of research exams: 1 Effective Dose (mSv) for 1 exam: 0.6 Total Effective Dose (mSv)*: 0.6"
15802535|NCT04430127|Other|No supplementary intervention is performed|No supplementary intervention will be applied
15802536|NCT04430114|Device|branched prosthesis for surgical treatment of thoraco-abdominal aortic aneurysms|"Jotec TAAA spinal loop graft custom made CE equivalent branched prosthesis, compared with the cohort of patients already treated with standard prostheses and / or Gelweave ™ Coselli Thoracoabdominal Grafts."
15802537|NCT04430101|Procedure|Minimally invasive stabilization of Lisfranc injuries|Patients with positive weightbearing radiographs will be operated by minimally invasive stabilization (eg, isolated homerun screw)
15802538|NCT04430101|Procedure|Conservative treatment|Patients with negative weightbearing radiographs will be treated conservatively
15802539|NCT04430088|Drug|VVZ-149 Injections|IV infusion of 1000 mg of VVZ-149
15802540|NCT04430088|Drug|Placebo|IV infusion of 0 mg of VVZ-149
15802541|NCT04430075|Device|Edwards PASCAL Transcatheter Valve Repair System|Transcatheter Valve Repair with Edwards PASCAL System
15802542|NCT04430062|Procedure|Surgical procedures performed under general anesthesia|Surgical procedures performed under general anesthesia in patients with perioperative SARS-CoV-2 infection
15802543|NCT04430049|Procedure|Covid ICU containment measures|The french containment measures during Covid-19 pandemic result in a restrictive visitation for relatives in ICU
15802548|NCT04430023|Other|epidemiological and demographic characteristics|Patients' age, gender, BMI, medical history, symptoms at admission (e.g., cough, fever, myalgia, gastrointestinal symptoms, headache), concomitant diseases (e.g., diabetes mellitus, hypertension, chronic lung disease, cerebrovascular disease, kidney disease, heart disease, cancer, smoking
15802549|NCT04430010|Behavioral|BEST in CLASS|BEST in CLASS is a Tier-2 evidence based program (EBP) that has demonstrated effectiveness at reducing children's Disruptive Behavior Problems (DBPs) and risk for Emotional and Behavioral Disorders (EBDs)
15802550|NCT04429997|Procedure|Removal of fibrosynovial tissue|Remove of fibrosynovial tissue at the superior border of patella
15802551|NCT04429997|Procedure|Non-removal of fibrosynovial tissue|Do not remove of fibrosynovial tissue at the superior border of patella
15802552|NCT04429984|Drug|Velaglucerase alfa (VPRIV)|Participants with Gaucher disease will receive VPRIV therapy for 12 months.
15802553|NCT04429971|Other|PrEP screening program|ICAP Pre-Exposure Prophylaxis (PrEP) Screening for Substantial Risk and Eligibility tool
15802554|NCT04429971|Other|PrEP starter pack|emtricitabine/tenofovir alafenamide or emtricitabine/tenofovir disoproxil
15802555|NCT04429958|Other|GDM|different degrees of hyperglycaemia during pregnancy
15802556|NCT04429945|Device|Virtual Reality|Virtual Reality Headset with Virtual Reality Applications
15802557|NCT04429932|Other|Myblu flavor A_2.4|Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine
15802558|NCT04429932|Other|Myblu flavor B_2.4|Use of Myblu e-cigarette with flavor 2 at 2.4% nicotine
15802559|NCT04429932|Other|Myblu flavor C_2.4|Use of Myblu e-cigarette with flavor C at 2.4% nicotine
15802560|NCT04429932|Other|Myblu flavor D_2.4|Use of Myblu e-cigarette with flavor D at 2.4% nicotine
15802561|NCT04429932|Other|Myblu flavor E_1.2|Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine
15802562|NCT04429932|Other|Myblu flavor F_1.2|Fse of Myblu e-cigarette with flavor F at 1.2% nicotine
15802563|NCT04429932|Other|Myblu flavor G_2.4|Use of Myblu e-cigarette with flavor G at 2.4% nicotine
15802564|NCT04429932|Other|Myblu flavor H_2.4|Use of Myblu e-cigarette with flavor H at 2.4% nicotine
15802565|NCT04429919|Drug|AP-325|During the 10-day double-blind treatment period (Days 1 to 10), subjects will take 4 capsules of the IMP orally once daily in the morning before breakfast.
15802566|NCT04429919|Drug|Placebo|During the 10-day double-blind treatment period (Days 1 to 10), subjects will take 4 capsules of the IMP orally once daily in the morning before breakfast.
15802567|NCT04429906|Device|Huami smart wearable device|"Wear the pulse-oxygen monitoring finger set of the medical monitor while wearing the Huami Smart Wearable device on the ipsilateral wrist according to the instructions for use. The medical monitor displays a steady pulse oximetry level for at least 30 seconds, starts the first measurement, slides the main dial page of the wearable device to the Oxygen Saturation measurement interface, clicks the measurement button to start the single measurement of blood oxygen saturation. Record the pulse oximetry and pulse rate values measured at the same time by the medical monitor and the Huami Smart Wearable Pulse Oximetry Device, respectively. After an interval of 30 seconds, repeat the above steps to start the second measurement and record the measured value. After an interval of 30 seconds, repeat the above steps to start the third measurement and record the measured value. The average of three measurements was taken as data for the test group."
15802568|NCT04429893|Drug|magnesium sulphate|assess the pain intensity of magnesium sulphate as an adjuvant to bupivacaine in serratus anterior plane block for modified radical mastectomy
15802569|NCT04429893|Drug|bupivicaine|assess the pain intensity of magnesium sulphate as an adjuvant to bupivacaine in serratus anterior plane block for modified radical mastectomy
15802570|NCT04429880|Drug|Oxytocin|Oxytocin given by intravenous route
15802571|NCT04429867|Drug|Hydroxychloroquine|Hydroxychloroquine 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses
15802572|NCT04429867|Drug|Placebo|Placebo 400 mg PO BID x 2 doses, then 200 mg PO BID x 8 doses
15802575|NCT04429841|Procedure|Radical gastrectomy with D1 lymphadenectomy|
15802576|NCT04429841|Procedure|Radical gastrectomy with D2 lymphadenectomy|
15802577|NCT04429828|Other|COVID-19 e-package: Psychological wellbeing for healthcare workers|All healthcare students have access to a COVID-19 educational learning package around psychological wellbeing (usual practice). In this study the investigators will conduct semi-structured qualitative interviews with healthcare students about their mental wellbeing, and use of this e-package.
15802578|NCT04429815|Diagnostic Test|Serological test for COVID-19.|Serological test for COVID-19 performed as part of standard of care.
15802580|NCT04429789|Behavioral|Active-Alert Hypnosis|Participants in this arm will receive four one-hour weekly sessions that will include training in a rapid self-hypnosis method. Participants will learn how to use waking hypnosis to manage fatigue using exercises with sensory experiences.
15802581|NCT04429789|Behavioral|Traditional Hypnosis|Participants in this arm will receive four one-hour weekly sessions where participants will learn how to use hypnosis along with relaxation. The exercises and suggestions included in the training will be adapted from the protocol used in a series of studies on the efficacy of self-hypnosis training for the management of chronic pain in persons with disabilities, and from a therapist guide of procedures and hypnotic suggestions for chronic pain.
15802582|NCT04429776|Diagnostic Test|Drug level testing|These will be carried out at the CfMR labs at the University of Manchester.
15802583|NCT04429763|Biological|Umbilical cord derived mesenchymal stem cells|One dosis of 1*10^6 cells/Kg
15802584|NCT04429763|Biological|Placebo|Placebo
15802585|NCT04429750|Procedure|Immediate umbilical cord clamping|"In the immediate cord clamping group, the umbilical cord will be clamped within the first 20 seconds after birth and the infant will be transferred to the resuscitation room. The newborn infant will be intubated and mechanically ventilated as quickly as possible on the resuscitation table as recommended in the French Programme National de Soins.
~After cardiorespiratory stabilization (i.e. heart rate>120/min, increasing preductal O2 saturation or achieving acceptable preductal SpO2 targets between 80 and 95%), the infant will be transferred to the neonatal intensive care unit (NICU). Oxytocin is infused to the mother as recommended in the local protocol (usually just after birth or cord clamping)."
15802586|NCT04429750|Procedure|intact cord resuscitation|The umbilical cord will be kept intact during the initial phase of the resuscitation. The infant will be placed on a specifically designed compact trolley with a warmed platform, suitable for commencing resuscitation between the mother's legs in case of vaginal birth or near the operating table beside the mother in case of cesarean section. This trolley will be fully equipped for resuscitation, including a suction device, gas flowmeter/blender, ventilatory support, and monitoring system. Its height can be adjusted in order to position the infant close to the maternal perineum. The infant will be intubated and mechanically ventilated on this trolley. The cord will be clamped once cardiorespiratory stabilization will be obtained (i.e. heart rate>120/min, increasing preductal O2 saturation or achieving acceptable preductal SpO2 targets between 80 and 95%) or in case of spontaneous placental expulsion. The infant will be then transferred to the neonatal intensive care unit (NICU).
15802587|NCT04429737|Dietary Supplement|clam protein capsules|The prediabetes patients in this arm will receive Clam protein capsules with a dose for 2g/d (500mg/capsule, 2 capsules/time, 2 times/day at day and night ) for 6 months ( Blood draw every 3 months) . After taking tested substance 6 months, the prediabetes patients will be continuous tracked for 3 years and be blood drawed every 6 months.
15802588|NCT04429737|Dietary Supplement|Clam peptide plus Chlorella capsules|The prediabetes patients in this arm will receive Clam peptide plus Chlorella capsules with a dose for 2g/d (500mg/capsule, 2 capsules/time, 2 times/day at day and night ) for 6 months ( Blood draw every 3 months) . After taking tested substance 6 months, the prediabetes patients will be continuous tracked for 3 years and be blood drawed every 6 months.
15802589|NCT04429737|Dietary Supplement|Placebo|The prediabetes patients in this arm will receive Placebo with a dose for 2g/d (500mg/capsule, 2 capsules/time, 2 times/day at day and night ) for 6 months ( Blood draw every 3 months) . After taking tested substance 6 months, the prediabetes patients will be continuous tracked for 3 years and be blood drawed every 6 months.
15802634|NCT04429347|Drug|Gabapentin|Friday night: 1 capsule of 300 mg, Saturday night: 2 capsule of 300 mg (total 600 mg), Sunday night: choice of 1 or 2 capsule of 300 mg (total of 300 or 600 mg)
15802590|NCT04429724|Diagnostic Test|Diagnostic test Covid-19|Three blood samples will be taken at day 1, month 3 and month 6 A prospective data collection will be set up at the level of symptoms and co-morbidities at each collection at D1, M3 and M6.
15802591|NCT04429711|Drug|Ivermectin Oral Product|3mg Capsules, 12-15mg/ day for 3 days
15802592|NCT04429698|Diagnostic Test|Point of care ultrasonography|Point-of-care Ultrasonography is an imaging method performed with ultrasound aid to facilitate rapid diagnosis and interventions during emergency intervention.
15802593|NCT04429685|Drug|Ketamine|Low dose ketamine - Ketalar (Racemic Ketamine Hydrochloride) Saline - Isotonic/Normal Saline
15802594|NCT04429685|Drug|Saline (placebo)|Saline (placebo)
15802595|NCT04429672|Behavioral|The Right to your Sexual Health|which is of a socio-educational type and is made up of five thematic axes; Sexual Rights, Sexuality, Reproductive Health, Sexual Behavior and Life Project divided into ten sessions (two weekly) of 30 minutes each, each session has a structure of opening, development and closing phase
15802596|NCT04429672|Behavioral|Friendly sexual health services and reproductive for adolescents|consists of six sessions (one a week) lasting 50 minutes each, using illustrative material through official flipcharts of the secretary of health on reproductive health, sexually transmitted diseases and sexual violence
15802597|NCT04429646|Device|Percutaneous left atrial appendage closure-LAMax|Interventional device, LAMax left atrial appendage closure system
15802598|NCT04429646|Device|Percutaneous left atrial appendage closure-Watchman|Interventional device, Watchman® LAA Closure Device
15802599|NCT04429633|Drug|Candesartan|If GLS decreased less than 18% or LVEF decreased to 45-50% during the treatment of adjuvant trastuzumab, start candesartan medication.
15802600|NCT04429620|Diagnostic Test|Immunfluorescence|Serum indirect immunofluorescent (IIF) method is used, analysis is performed under an automated microscope.
15802601|NCT04429607|Device|Erbium:YAG Laser|Erbium:YAG 2940nm will be performed using single spot, multiple pulses on lesions.
15802602|NCT04429607|Device|Pulsed Dye Laser|PDL will be performed using settings of 6-10 J/s2 on lesions.
15802603|NCT04429607|Device|Nd:YAG Laser|Nd:YAG 1064nm will be performed using settings of 60-110 J/s2 on lesions.
15802604|NCT04429607|Procedure|Electrodessication and curettage|Electrodessication and curettage will be performed using an epilating needle, followed by curettage on lesions.
15802605|NCT04429594|Other|blood sampling|blood sampling at J0, M6, M12, M24, M36, M48, M60
15802606|NCT04429581|Other|Anthropometry|
15802607|NCT04429568|Other|Smoked Cannabis|Cannabis will be purchased by the participants and reimbursed the full cost by the study. Participants will be asked to purchase enough to last 2 full days of use. To reduce variability between products, participants will be asked to purchase cannabis from one dispensary near the research facility (Purple Star MD at 2520 Mission St., San Francisco). Receipt must be provided to study staff.
15802608|NCT04429568|Other|Vaped Cannabis|Cannabis will be purchased by the participants and reimbursed the full cost by the study. Participants will be asked to purchase enough to last 2 full days of use. To reduce variability between products, participants will be asked to purchase cannabis from one dispensary near the research facility (Purple Star MD at 2520 Mission St., San Francisco). Receipt must be provided to study staff. All participants will use the study-provided PAX® (PAX 2) dry herb vaporizer, one of the most popular handheld vaporizers.
15802609|NCT04429568|Other|Tobacco Cigarette|Tobacco cigarettes of participants' choice (usual brand) will be provided by research staff for use on the study.
15802610|NCT04429555|Drug|Ibudilast|Ibudilast orally administered, 50 mg twice daily for 7 days.
15802611|NCT04429555|Drug|Placebo|Placebo orally administered, 50 mg twice daily for 7 days.
15802614|NCT04429529|Biological|TY027|TY027 Injection, (100 mg/5 mL/Vial), SARS-CoV-2 Monoclonal Antibody (mAb)
15802615|NCT04429529|Other|0.9% Saline|Placebo
15802616|NCT04429516|Drug|Morphine Sulfate|over-encapsulated Morphine Sulfate prolonged release 5mg tablet, twice daily for 14 days. Patients will then crossover after a 7 day wash out period.
15802617|NCT04429516|Drug|Placebo oral tablet|capsule containing Microcrystalline Cellulose Ph. Eur, 5 mg twice daily
15802618|NCT04429503|Drug|aflibercept|Intravitreally (IVT) administered as a liquid formulation in a vial
15802619|NCT04429503|Drug|High-dose aflibercept|Intravitreally (IVT) administered as a liquid formulation in a vial
15802620|NCT04429490|Other|Adipose tissue sampling during surgery and urine sampling|Adipose tissue sampling during surgery and urine sampling
15802621|NCT04429477|Device|Cerebral compliance and hemodynamics monitoring|Noninvasive devices are been used to assess cerebral circulation and compliance.
15802623|NCT04429451|Biological|4SCAR-PSMA T cells|Infusion of 4SCAR-PSMA T cells at 10^6 cells/kg body weight via IV
15802624|NCT04429438|Biological|4SCAR19 and 4SCAR20/22/70/PSMA/13/79b/GD2|Patients who have relapsed and refractory B cell lymphoma (BCL) after conventional chemotherapy will be treated with multiple 4SCAR gene-engineered T cells
15802625|NCT04429425|Procedure|epidural anesthesia|epidural anesthesia through epidural injection of a local anaesthetic combined with an opioid
15802626|NCT04429412|Behavioral|MCT+|Metacognitive training
15802627|NCT04429399|Other|decrease the positive end expiratory pressure (PEEP)|decrease the PEEP going from high (according to ExPress Trial) to low level
15802628|NCT04429399|Other|mechanical features assessment|evaluation of the mechanical features of respiratory system
15802629|NCT04429399|Other|shunt assessment|evaluation of the pulmonary shunt during two different ventilation setting
15802630|NCT04429386|Procedure|Bariatric surgery|Laparoscopic bariatric surgery including gastric bypass and sleeve gastrectomy
15802631|NCT04429373|Procedure|Implant installation with PRF membrane|Platelet-rich fibrin membrane over the buccal aspect of implant site after dental implant installation
15802632|NCT04429373|Procedure|Implant installation without PRF membrane|Implant installation contralateral to the experimental side without PRF membrane
15802633|NCT04429360|Procedure|pelvic reconstructive surgery|Pelvic reconstructive surgery
15805451|NCT04405713|Procedure|from the onset of symptoms beyond 7 days|ELC after 7days of onset of ACC
15802636|NCT04429347|Drug|Tizanidine|Friday night: 1 capsule of 2 mg, Saturday night: 2 capsule of 2 mg (total 4 mg), Sunday night: choice of 1 or 2 capsules of 2 mg (total of 2 or 4 mg)
15802637|NCT04429334|Drug|nangibotide|nangibotide 1.0 mg/kg/h
15802638|NCT04429334|Drug|placebo|matching placebo
15802639|NCT04429321|Drug|Nivolumab|Nivolumab 3 mg/kg IV every four weeks, first in combination with capecitabine then alone
15802640|NCT04429321|Drug|Ipilimumab|ipilimumab 1/mg/kg IV every 3 weeks x 4 cycles, in combination with Nivolumab
15802641|NCT04429321|Device|bland embolization|Lipiodol:ethanol embolization of their primary or target tumor
15802642|NCT04429308|Procedure|Photodynamic Therapy|Photodynamic Therapy consists of (Levulan Kerastick (aminolevulinic acid HCL) topical solution, 20% + BLU-U Photodynamic Light Therapy)
15802643|NCT04429308|Drug|Chemical Peels|Chemical peels consists of a combination of Jessner's Solution: Composed of Salicylic Acid (14%), Medical Grade Lactic Acid (14%), Medical Grade Resorcinol (14%), Denatured Ethyl Alcohol AND 35% Trichloroacetic acid peels
15802644|NCT04429295|Biological|DTwP-HepB-Hib-IPV hexavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b, inactivated poliovirus)|Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
15802645|NCT04429295|Biological|DTwP-HepB-Hib pentavalent vaccine (Diphtheria toxoid, Tetanus toxoid, whole cell pertussis, Hepatitis B surface antigen (HBsAg), Haemophilus influenzae type b)|Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
15802646|NCT04429295|Biological|Inactivated Poliomyelitis Vaccine|Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
15802647|NCT04429295|Biological|Poliomyelitis Vaccine bivalent types 1 and 3|Pharmaceutical form:Oral suspension Route of administration: Oral
15802648|NCT04429295|Biological|Human Rotavirus, live attenuated|Pharmaceutical form:Oral suspension Route of administration: Oral
15802649|NCT04429295|Biological|Pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed)|Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
15802650|NCT04429282|Drug|ibuprofen|Patients were randomly divided into three groups in radio 1:1:1 received respectively IV placebo, ibuprofen 400 mg or ibuprofen 800 mg. The first dose of study drugs was administered intravenously at the time of wound closure and then every 6 hours within 48 hours after the operation.
15802651|NCT04429282|Drug|Placebo|Placebo
15802652|NCT04429269|Diagnostic Test|mammography and ultrasound screening|Patients screened by both mammography and ultrasound.
15802653|NCT04429256|Other|data collection|retrospective analysis of perioperative data collected from patient medical charts and from a telephone enquiry
15802654|NCT04429243|Device|GORE® VIABAHN® Stent Graft|On Day 1, participants will receive the GORE® VIABAHN® Stent Graft.
15802655|NCT04429230|Device|Active Transcranial pulsed current stimulation (tPCS)|Active tPCS will be delivered through a pair of saline soaked (0.9% NaCl) surface sponge electrodes. Anodal stimulation will be given to brain area based on qEEG findings
15802656|NCT04429230|Device|Sham Transcranial pulsed current stimulation (tPCS)|Electrode placement will be the same as active stimulation but the electric current will be ramped down 5 seconds after the beginning of the stimulation to make this condition indistinguishable from the experimental active stimulation.
15802657|NCT04429217|Other|immediate post-operative complete weight-bearing after surgery|"Patients randomized to the experimental post-operative rehabilitation intervention will undergo to immediate complete weight-bearing starting immediately after surgery. Immediate complete weight-bearing consists in the possibility to undergo all the everyday activities without limiting weight-bearing and without the use of walking aids.
~During the rehabilitation period, patients will wear an ankle brace (VACOankle® OPED); this will ensure the safety of the early recovery phases, protecting from dangerous movements while allowing the mobilization in the healthy range of movement."
15802658|NCT04429217|Other|delayed weight-bearing for 6 weeks after surgery|"Patients randomized to the control post-operative rehabilitation intervention will undergo to delayed weight-bearing starting at 6-weeks post-operatively. Delayed weight-bearing consists in the limitation of the weight-bearing to 20-30% of patient's total weight using crutches for the first 6 weeks after surgery.
~During the rehabilitation period, patients will wear an ankle brace (VACOankle® OPED)."
15802659|NCT04429204|Procedure|Biospecimen Collection|Undergo collection of tissue
15802660|NCT04429204|Procedure|Cryosurgery|Undergo cryoablation
15802661|NCT04429191|Biological|Humanized anti-CD117 Monoclonal Antibody (JSP191)|Procedure: single intravenous infusion of JSP191 antibody
15802662|NCT04429178|Other|ultrasound|portal vein pulsatility fraction (percent) measured with ultrasound
15802663|NCT04429165|Other|collection of Patient Reported Outcome (PRO) data|collection of Patient Reported Outcome (PRO) data by questionnaires
15802664|NCT04429165|Other|collection of anthropometric and clinical functional data|collection of anthropometric and clinical functional data including range of motion (ROM), isokinetic muscle strength, joint position sense, single leg balance ability, and muscle activity
15802665|NCT04429165|Other|gait analysis|gait analysis in a motion capture volume on a walkway including force plates and on a treadmill with pressure plates, while 3D kinematics and kinetics, pressure and electromyographic (EMG) data will be recorded
15802666|NCT04429152|Drug|Doravirine/Lamivudine/Tenofovir|DOR/3TC/TDF 100/300/300 mg once daily fixed-dose combination
15802667|NCT04429139|Drug|photodynamic therapy|PDT with Visudyne® was performed under general anesthesia according to the standard TAP study with some modifications: Verteporfin (6 mg/m2, Visudyne®; Novartis International AG, Basel, Switzerland) was injected intravenously with a standard 10-min infusion followed by followed by application of diode laser (Opal Photoactivator; Coherent Medical Group, Santa Clara, USA) (689 nm, 50 J/cm2, 600 mW/cm2) for 200 seconds to generate 120 J/cm2.
15802668|NCT04429126|Behavioral|Acupressure|Two types acupressure interventions, 5-point and 2-point acupressure groups, will be conducted in the current study.
15802669|NCT04429113|Device|Maxillary expansion with conventional Quad Helix bonded on molars.|Maxillary expansion with conventional Quad Helix bonded on molars
15802767|NCT04428333|Drug|Feladilimab|Humanized anti-inducible T cell co-stimulatory receptor (ICOS) immunoglobulin G4 (IgG4) monoclonal antibody (mAb)
15802768|NCT04428333|Drug|Pembrolizumab|Humanized anti- programmed cell death receptor1 (anti-PD-1) IgG4 mAb
15802769|NCT04428333|Drug|Placebo|Sterile normal saline
15802670|NCT04429100|Diagnostic Test|Magnetic Resonance Imaging|One novel MRI sequence, i.e. the quantitative imaging of macromolecular proton fraction (MPF), will be introduced into this study. MPF is defined as the relative amount of protons associated with macromolecules involved in magnetization exchange with free water protons. This parameter is independent of the pool model used for quantification and the pulse sequences used for data acquisition. Recent studies have found a strong association between MPF and collagen content in the fibrotic liver, indicating MPF is a potential biomarker of early-stage liver fibrosis.
15802671|NCT04429087|Drug|BI 764532|BI 764532
15802672|NCT04429074|Procedure|Minimally invasive distal pancreatectomy|Minimally invasive distal pancreatectomy
15802673|NCT04429061|Behavioral|SKILLZ-Girl curriculum|Participation in the SKILLZ-Girl curriculum and SKILLZ-Club
15802674|NCT04429048|Device|Acupressure elastic band (Sea-Band)|The PC6 acupressure was done via Sea-Band in persistent compressive state for 3 minutes per time and three times a day , then at least 5 days in one week for 6 weeks continuously except modern routine standard therapy
15802675|NCT04429048|Device|General elastic band (no bud)|general elastic band was put over bilateral PC6 acupoints
15802676|NCT04429035|Dietary Supplement|Vitamin K2|Administration of 300 μg Vitamin K2 (MQ7) daily p.o
15802677|NCT04429035|Dietary Supplement|Placebo|Administration of 300 μg Vitamin K2 (MQ7) Placebo daily p.o
15802678|NCT04429022|Drug|Gabapentin|600mg PO PO x 1 prior to surgery (in pre-op) 300mg PO BID for 7 days post op
15802679|NCT04429022|Drug|Acetaminophen|Acetaminophen 1000mg PO x1 prior to surgery (in pre-op) Acetaminophen 1000mg PO q6h x 2 days then 1000mg q6h PRN post op
15802680|NCT04429022|Drug|Celecoxib|Celecoxib 200mg PO q 12h x 7d post op
15802681|NCT04429022|Drug|Ketorolac|30mg IV once at end of hysterectomy procedure
15802682|NCT04429022|Procedure|Paracervical block with ropivacaine|0.5% ropivacaine; 10 mL bilaterally (2 point) for total of 20mL
15802683|NCT04429022|Procedure|Local anesthetic injection with ropivacaine at abdominal laparoscopic port sites|0.5% ropivacaine; at all laparoscopic port sites; another 10mL ropivacaine in total
15802684|NCT04429022|Drug|Hydromorphone|1mg IV PRN q3h, post op, while inpatient
15802685|NCT04429022|Drug|Oxycodone|To be discharged home with: 12 tabs of 5mg PRN q4h
15802686|NCT04429009|Device|ZEPHYRx Respiratory Therapy (RT) System|A breath controlled video game system for respiratory therapy
15802687|NCT04429009|Device|Standard Incentive Spirometer|A simple (not digital) plastic device that contains a piston that rises inside the device and measures the volume of your breath
15802688|NCT04428996|Behavioral|Social Cognition and Interaction Training (SCIT)|The social cognition and interaction training (SCIT) is a manual-guide group intervention that can apply to people with serious mental illness. There have been evidences showing that the SCIT could improve emotional perception, theory of mind, attribution bias, and social relationship.
15802689|NCT04428983|Dietary Supplement|Hericium erinaceus mycelium|Hericium erinaceus capsules 3 tables per day for 24 months
15802690|NCT04428970|Procedure|Invasive ICP monitoring|Insertion of a parenchymal pressure measuring probe
15802691|NCT04428957|Other|Telemonitoring|Daily telemonitoring of heart rate (HR), blood pressure (BP), pulse oximetry (SpO2), spirometry (FVC), activity (accelerometry) and severity of cough and dyspnea
15802692|NCT04428944|Procedure|Wide Circumferential Pulmonary Vein Antrum Isolation (PVAI)|Standard PVI
15802693|NCT04428944|Procedure|Pulmonary Vein Antrum Isolation Plus Driver Ablation (PVAI+drivers)|Standard PVI + Ablation of drivers in LA and RA
15802694|NCT04428944|Procedure|Pulmonary Vein Antrum Isolation Plus Box Isolation of Posterior Wall (PVAI+box)|Standard PVI + Electrical isolation of the posterior wall of the left atrium
15802695|NCT04428905|Other|Quality-of-Life Assessment|Ancillary studies
15802696|NCT04428905|Other|Questionnaire Administration|Ancillary studies
15802697|NCT04428905|Other|Survivorship Care Plan|Receive personalized care plan/resource manual
15802698|NCT04428905|Other|Telemedicine|Participate in telehealth sessions
15802699|NCT04428892|Behavioral|Pedagogyc Strategy|Simulation can be used as a pedagogic tool that provides students with significant learning regarding decision-making in interacting with people, in this case patients with LBP. It is a potential strategy for developing diverse skills focused on the safety of the patient and the therapist.
15802700|NCT04428879|Drug|Topotecan Episcleral Plaque|Sustained Release Episcleral Topotecan Plaques (Chemoplaques) are glued to bare, dry sclera of the eye under conjunctiva and Tenon's capsule. A rolling six dose interpatient escalation schema will be employed. Chemoplaques with 0.6 mg and 0.9 mg of topotecan HCl formulation are available. Patients will receive 1 or 2 Chemoplaques per eye, to deliver 5 escalating doses: 0.6, 0.9, 1.2 [2x0.6], 1.5 [0.6+0.9] or 1.8 [2x0.9] mg. The prescribed dose will escalate or de-escalate by 0.3 mg at each level, and no patient will receive more than 1.8 mg of topotecan hydrochloride due to the physical limitations if the devices available. The planned removal is 42 days ± 7, unless dose limiting toxicity is observed, in which case the plaque is removed as soon as possible. The observation period for the purposes of dose-escalation will be 63 days (i.e. 21 days following Chemoplaque removal on day 42).
15802701|NCT04428866|Diagnostic Test|Continuous Glucose Monitoring|A CGM sensor (Dexcom G4 or other professional version available at onset of study) will be placed during visit 1 in blinded (masked) mode, and will be worn for 10 days. Data will be analyzed to determine patterns of glucose during both day and night intervals.
15802702|NCT04428866|Diagnostic Test|activity monitor|The activity monitor (Fitbit Charge 2) will be worn by participants for 10 days to assess activity, concurrent with CGM sensor wear.
15802703|NCT04428866|Diagnostic Test|Mixed meal tolerance test|After an overnight fast, participants will be given a standard liquid mixed meal; blood samples will be collected at baseline (fasting) and at defined time points after a meal for metabolic and hormonal analyses.
15802704|NCT04428866|Diagnostic Test|Glucagon Sensitivity Testing|After baseline blood sampling, glucagon will be administered by injection, and blood samples will be collected for analysis of glucose and hormone responses. This will allow us to assess whether sensitivity to glucagon is altered in PBH.
15802764|NCT04428359|Drug|Measles-Mumps-Rubella Vaccine|Group A patients will receive intralesional injection of upto 0.5 mL of reconstituted MMR vaccine into a single or a maximum of 5 warts at a time in case of multiple warts. Intralesional injection will be given every three weeks for a maximum of 5 doses or until complete resolution, whichever is earlier.
15802705|NCT04428866|Diagnostic Test|Hypoglycemic Hyperinsulinemic Clamp|This test will assess hormonal responses to hypoglycemia. Participants will arrive after an overnight fast. After baseline blood sampling, an infusion of insulin and glucose will be started, and infusions will be adjusted to allow glucose levels to drop very gradually. Blood samples will be collected for measurement of hormonal responses to lowering of glucose. This test will allow us to determine whether secretion of hormones which counteract hypoglycemia (counterregulatory hormones) is reduced in patients with PBH as compared with other groups.
15802706|NCT04428866|Diagnostic Test|analysis of fecal microbiome|Participants will be asked to provide a fecal sample, collected at home, which will be analyzed to determine the types of bacteria present in the feces.
15802707|NCT04428853|Behavioral|iyengar yoga|different yoga postures including warm up, cool down and meditation that incorporate 75 minutes of training
15802708|NCT04428840|Device|Self-measurement kiosk|Use of the self-measurement kiosk, with results forwarded to the triage nurse screens
15802709|NCT04428827|Procedure|Unilateral adrenalectomy in patients with unilateral disease|Unilateral adrenalectomy in patients with unilateral disease
15802710|NCT04428814|Biological|CT-P43|45mg single dose
15802711|NCT04428814|Biological|EU-approved Stelara|45mg single dose
15802712|NCT04428814|Biological|US-licensed Stelara|45mg single dose
15802713|NCT04428801|Biological|autologous adipose-derived stem cells|Culture expanded mesenchymal stem cells isolated from a patient's own abdominal fat tissue
15802714|NCT04428788|Drug|CC-94676|CC-94676
15802715|NCT04428775|Drug|ALZT-OP1a (cromolyn)|"Mast cell stabilizer
~Neuroinflammatory microglial modulator
~anti-inflammatory"
15802716|NCT04428762|Device|I-Port Advance use|participants will apply I-port advance for 4 weeks and will inject all insulin through the port. follow up 3 months with/ without i-port.
15802717|NCT04428749|Diagnostic Test|Yale Swallow Protocol|The YSP is a three-step method consisting of an assessment of the patient's awareness, the patient's ability to follow simple instructions and finally the patient's ability to drink 90 ml water from a cup or by straw without stopping, choking or coughing.
15802718|NCT04428749|Diagnostic Test|FEES (fiberoptic endoscopic evaluation of swallowing)|"The FEES will be performed bedside by an experienced occupational therapists. The patient will be sitting upright in a chair and be given 1) 2 spoons of applesauce, 2) 2 spoons of water, 3) several sips of water, 4) 90 ml of water. All items colored blue.
~The FEES will use a single-use AMBU rhino-laryngo scope slim and the AMBU monitor. the examination will be terminated in case of aspiration below the vocal cords."
15802719|NCT04428736|Behavioral|Disclosure Toolkit|"Participants will receive a Disclosure Toolkit consisting of a family letter, gene information chatbot, and informational website to aid in communicating their genetic test results with at-risk relatives."
15802720|NCT04428723|Other|Entry of demographic and medical history data into a deidentified database|Entry into repository for analysis.
15802721|NCT04428723|Genetic|Blood sample for DNA analysis|Targeted resequencing of DNA to identify variants associated with hypoglycemia, comparing participants with hypoglycemia (both surgical and non-surgical) and healthy controls.
15802722|NCT04428723|Diagnostic Test|Stool sample for microbiome analysis|Participants will be asked to provide a fecal sample, collected at home, which will be analyzed to determine the types of bacteria present in the feces.
15802723|NCT04428723|Diagnostic Test|Mixed meal tolerance test|For a subset of participants: After an overnight fast, participants will be given a standard liquid mixed meal; blood samples will be collected at baseline (fasting) and at defined time points after a meal for metabolic and hormonal analyses.
15802724|NCT04428723|Diagnostic Test|Continuous glucose monitoring|A CGM sensor (Dexcom G4 or other professional version available at onset of study) will be placed in blinded (masked) mode, and will be worn for 10 days. Data will be analyzed to determine patterns of glucose during both day and night intervals.
15802725|NCT04428723|Diagnostic Test|activity monitor|The activity monitor (Fitbit Charge 2) will be worn by participants for 10 days, to assess activity, concurrent with CGM sensor wear.
15802726|NCT04428710|Other|assessment with psychometric questionnaire|"At the initial genetic consultation patients are informed about hereditary cancer risk and the genetic testing process. At the second genetic counseling appointment, after patients done tests, all participants were informed about the study purpose, and they signed the informed consent before the psychometric assessment. Those patients who agreed to participate, they were given the questionnaires to fill in. Also, background characteristics were reported including age, marital relationship, level of education, psychiatric antecedents.
~The time for completion the self-report measures was about 10 minutes. The psychometric assessment was occurred prior to delivering the results of genetic testing."
15802727|NCT04428697|Procedure|Sungurtekin Technique|Sungurtekin technique was performed through the base of the posterior fissure; thus, no additional incision was necessary in the lithotomy position. The mucosa was dissected along the submucosal plane, starting at the hypertrophic papilla, and extended for 1.5 cm, a 0.5-cm section of the bottom part of the internal anal sphincter was measured and marked with a ruler. Next, the internal sphincter bundle was measured with a sterile scale and a mark was placed at 1 cm towards the proximal end. The internal sphincter cut with cautery .
15802728|NCT04428684|Drug|Pepti 3.6 mg|Each patient receives one injection of Pepti 3.6mg or Zoladex 3.6mg on Day 0 and a second injection of the same drug given the first time on Day 28. On Day 42 patients undergo endometrial ablation
15802729|NCT04428671|Biological|Cemiplimab|Given IV
15802730|NCT04428671|Radiation|Radiation Therapy|Undergo standard of care radiation therapy
15802731|NCT04428671|Procedure|Therapeutic Conventional Surgery|Undergo standard of care surgery
15802732|NCT04428658|Behavioral|Home-based video visits|Receiving home-based video visits with a pediatric endocrinologist in between in-person diabetes clinic visits.
15802733|NCT04428658|Behavioral|Standard of Care|Receiving initial assistance with setting up secure platforms for diabetes data-sharing and usual quarterly in-person care at the UCD Pediatric Diabetes Clinic.
15802765|NCT04428359|Drug|Vit D|Group B patients will receive a maximum of 0.5 mL Inj. Vitamin D3 (600,000 IU; 15mg/ml) in each session after injection of IL lignocaine with 31 G insulin syringe. In cases of multiple warts, a maximum of 5 warts will be injected at a time. The session will be done at 3 weekly intervals for a maximum of 5 sessions or until complete resolution of warts, whichever is earlier
15802770|NCT04428333|Drug|Platinum based chemotherapy|Cisplatin/carboplatin
15802771|NCT04428333|Drug|Fluorouracil (5FU)|5-fluorouracil
15802734|NCT04428645|Device|DailyDose Decision Support|DailyDose provides on-demand, real-time dosing recommendations for insulin meal boluses and basal insulin doses as well as the option to receive recommendations for meals and exercise. DailyDose is an information system comprised of (1) a smart phone app that both collects continuous glucose measurement (CGM) data, insulin data, and fitness data and presents suggestions back to the user, (2) a cloud based information system that stores the raw data and relays suggestions to the user, (3) a glucoregulatory model, automatically personalized for each user, that resides on a cloud server and is fit with the user's individual glucose data, and (4) an adaptive agent that provides insulin dosing options and suggestions as well as meal and exercise recommendations to the user based on the subject's own outcomes and simulations done on the glucoregulatory model.
15802735|NCT04428632|Drug|Berotralstat|One 150mg capsule administered orally once daily
15802736|NCT04428619|Device|Peripheral Electrical Nerve Field Stimulation (PENFS) Device|Patients will complete daily worst abdominal pain and bowel habit questionnaires for 1 week prior to initial PENFS device placement to provide a baseline. At visit 1, patients will complete the Bowel Symptom Questionnaire, IBS Symptom Severity Scale (IBS-SSS), PROMIS Belly Pain Scale, Gas and Bloating, Constipation, and Diarrhea Scales, Hospital Anxiety and Depression Scale, and Visceral Sensitivity Index, heart rate variability will be measured, and they will have the initial PENFS device placed. Patients will complete daily worst abdominal pain (scale 0-10) questionnaires throughout the duration of the study. They will return every 7 days for a total of 4 visits for device replacement and additional questionnaires, including the IBS-SSS. Four devices will be placed in total (start of weeks 1, 2, 3, and 4). Stimulation time is 5 days/week during each of the 4 consecutive weeks. Additional questionnaires will be completed at the end of week 4 and at extended follow-up (8 weeks).
15802737|NCT04428619|Device|Sham Device|Patients will complete daily worst abdominal pain and bowel habit questionnaires for 1 week prior to initial sham device placement to provide a baseline. At visit 1, patients will complete the Bowel Symptom Questionnaire, IBS Symptom Severity Scale (IBS-SSS), PROMIS Belly Pain Scale, Gas and Bloating, Constipation, and Diarrhea Scales, Hospital Anxiety and Depression Scale, and Visceral Sensitivity Index, heart rate variability will be measured, and they will have the initial sham device placed. Patients will complete daily worst abdominal pain (scale 0-10) questionnaires throughout the duration of the study. They will return every 7 days for a total of 4 visits for device replacement and additional questionnaires, including the IBS-SSS. Four devices will be placed in total (start of weeks 1, 2, 3, and 4). Stimulation time is 5 days/week during each of the 4 consecutive weeks. Additional questionnaires will be completed at the end of week 4 and at extended follow-up (8 weeks).
15802738|NCT04428606|Dietary Supplement|Metabolic Rheostat|Metabolic Rheostat™ Ingredients: Ginseng extract, Ginseng root extract, berberine chloride, Livaux (gold kiwi powder), MegaSporeBiotic, and MenaquinGold (vitamin K2-7) powder
15802739|NCT04428606|Dietary Supplement|Butyrate Ultra|An anerobic probiotic supplement that contains butyrate-producing Butyricicoccus pullicaecorum 25-3T, vitamin K2, and fenugreek to maintain healthy glucose balance.
15802740|NCT04428606|Dietary Supplement|Placebo|Placebo
15802741|NCT04428593|Drug|Treamid 5 mg|The volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break.
15802742|NCT04428593|Drug|Treamid 15 mg|The volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break.
15802743|NCT04428593|Drug|Treamid 50 mg|The volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break.
15802744|NCT04428593|Drug|Placebo|The volunteers received the study drug once, and then continued daily intake for 14 days after a 6-day break.
15802745|NCT04428580|Other|Online FBT Training|Therapists will receive online training in Family-Based Treatment (FBT)
15802746|NCT04428580|Other|Webinar FBT Training|Therapists will receive webinar training in Family-Based Treatment (FBT)
15802748|NCT04428554|Radiation|Experimental arm|Consolidative radiotherapy (pelvic irradiation and/or metastases irradiation) + standard of care +/- previous transurethral resection of bladder tumor
15802749|NCT04428541|Other|Questionnaire for visual function assessment of preverbal children|18 items questionnaire
15802750|NCT04428502|Drug|Enbrel|As provided in real world practice
15802751|NCT04428489|Other|Observation and necessary supportive care|For patients with ICUS and CCUS, necessary supportive care could be given. No addtitional treatment is administrated.
15802752|NCT04428476|Biological|CAP-1002|Peripheral infusion of 150 million allogeneic cardiosphere-derived cells administered every three months
15802753|NCT04428463|Procedure|Tachosil|tympanic membrane perforation repair using Tachosil patch under local anesthesia
15802754|NCT04428463|Procedure|fascia and cartilage|tympanic membrane perforation repair using fascia and cartilage under general anesthesia
15802755|NCT04428450|Device|Deprexis|CBT-based, integrative online self-help program
15802756|NCT04428437|Drug|Lenvatinib|Prescribed by physician.
15802757|NCT04428424|Drug|Enbrel|As provided in real world practice
15802759|NCT04428398|Diagnostic Test|Analysis of urine samples with flow cytometry|"Urine samples will be conserved and frozen upon arrival. All samples will be stained according to T cell and TEC (tubular epithelial cells) panel with fluorochromes.
~T cell panel: CD3, CD4, CD8, CCR7, CD45RO, CD28, CD279; TEC panel: vimentin, cytokeratine, CD10, CD13, CD227, CD326"
15802760|NCT04428385|Other|Testing incentive|A small incentive will be paid to the provider each time they perform a malaria rapid diagnostic test.
15802761|NCT04428385|Other|Conditional artemisinin combination therapy subsidy|An additional discount on WHO-approved quality assured ACTs will be offered to individuals with a positive RDT.
15802762|NCT04428372|Drug|Mannitol|Hypertonic mannitol infusion
15802763|NCT04428372|Drug|0.9% saline|Normal saline 'placebo' arm
15802766|NCT04428346|Behavioral|Incentive payment|Incentive payment to enhance HCV treatment uptake among people with recent injecting drug use attending needle and syringe programs.
15802772|NCT04428320|Procedure|Pelvic floor injection|Injection of 10 cc of bupivacaine
15802773|NCT04428307|Other|Conditional artemisinin combination therapy subsidy|An additional discount on WHO-approved quality assured ACTs will be offered to individuals with a positive RDT.
15802774|NCT04428307|Other|Testing incentive|A small incentive will be paid to the provider each time they perform a malaria rapid diagnostic test.
15802775|NCT04428281|Drug|RO7248824|RO7248824 will be administered as IT injection of varing dose levels over a period of 8 weeks, with a minimum of approximately 4 weeks between each dose administration.
15802776|NCT04428268|Drug|Chloroquine Phosphate Tablets|Orally administered
15802777|NCT04428255|Drug|HBM9161 Dose A|HBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly
15802778|NCT04428255|Drug|HBM9161 Dose B|HBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly
15802779|NCT04428255|Drug|Placebo|HBM9161 (Dose A or Dose B) or matching placebo will be administered IV weekly
15802780|NCT04428242|Device|RHMS-RTM|Assessment of retinal thickness.
15802781|NCT04428242|Diagnostic Test|SD-OCT|Assessment of retinal structure.
15802782|NCT04428229|Other|Optic nerve sheath diameter|Pre and post-trendelenburg optic nerve sheath diameter will be measured
15802783|NCT04428216|Other|Group RIB|In group RIB, RIB block will be performed. Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.
15802784|NCT04428203|Drug|Epidiolex Oral Liquid Product|patients with rising PSA after failure of localized therapy will receive Epidiolex PO once daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity. Patients receive an Epidiolex taper for 7-10 days after withdrawing from study for any reason or completion of the study period.
15802787|NCT04428177|Device|Intravascular lithotripsy|Intravascular lithotripsy uses sonic pressure waves to disrupt calcium with minimal impact to soft tissue of coronary vessel
15802788|NCT04428177|Device|Standart therapy|conventional preparation of calcified lesion: non-compliant, cutting or scoring ballons predilatation or rotational atherectomy
15802789|NCT04428164|Other|The Richards-Campbell Sleep Questionnaire (R-CSQ)|"Tool developed to assess patient satisfaction and comfort in the hospital setting.
~The R-CSQ is a scale used to measure different aspects of sleep quality. This scale allows the patient to rate their quality and amount of sleep on a scale of 0-100. The R-CSQ allows the patient to rate six different components of their sleep, including sleep depth, sleep latency, awakenings, returning to sleep, sleep quality, and noise."
15802790|NCT04428164|Other|Revised American Pain Society Outcome Questionnaire (APS-POQ-R)|The APS-POQ-R can be utilized to measure perceived levels of pain in patients. The APS-POQ-R scale is a validated scale that is used in the hospital setting with reliable and consistent results. This scale measures five aspects of a patient's perception and experiences with pain and a sixth aspect including nonpharmacological interventions.
15802798|NCT04428138|Diagnostic Test|In-office vascular visit|Every patient will undergo a complete physical examination in order to detect any clinical or sub clinical vascular disease.
15802799|NCT04428138|Diagnostic Test|Echo duplex scan of arterial system|Every patient will undergo a complete echo duplex scan in order to detect any morphological or hemodynamic alteration of aorta, carotid arteries and lower limb arteries.
15802800|NCT04428125|Diagnostic Test|Magnetic Resonance Scan of Thoracic outlet region|Both groups will undergo Magnetic Resonance Scan of cervicothoracobrachial region in order to study the anatomy of this region.
15802801|NCT04428125|Diagnostic Test|Duplex Ultrasound assessment of Upper limbs|Both groups will undergo Duplex Ultrasound assessment of Upper limbs, in order to study diameters and flow of the vascular system of the upper limbs.
15802802|NCT04428112|Behavioral|Building Better Caregivers Workshop|"Workshops consist of small group or about 20-25 persons. Two peer co-facilitators (caregiver themselves) will guide workshop activities. Participants will receive a workshop booklet. Each week, participants will log on at least 2-3 times for a total time of approximately two hours. Participants do not require real time attendance at pre-determined times."
15802803|NCT04428112|Behavioral|Attention Control|Participants will receive two brief 15-30 minutes phone calls by study staff, and will receive a handbook on dementia and caregiver resources while they wait for the workshop.
15802804|NCT04428099|Behavioral|Lifestyle change promotion program|The intervention consists of 8 group sessions centered on healthy physical activity, healthy diet, social life, Good Sleep Hygiene, healthy sun exposure, nature contact, how to stop ruminating, review and maintenance tips.
15802805|NCT04428099|Behavioral|Mindfullness based cognitive program|The intervention consists of 8 group sessions with a mindfulness-based cognitive program
15802806|NCT04428099|Behavioral|Written Information|Written information about lifestyle change suggestions
15802807|NCT04428086|Drug|Apatinib in arm1|Apatinib will be administered at a dose of 250 mg once daily from Day 4 to Day 9.
15802808|NCT04428086|Drug|Rosuvastatin|Rosuvastatin will be administered as a single oral 10 milligram (mg) dose on Day 1 and Day 7.
15802809|NCT04428086|Drug|Apatinib in arm2|Apatinib will be administered at a dose of 250 mg once daily from Day 3 to Day 7.
15802810|NCT04428086|Drug|Metformin|Metformin will be administered as a single oral 500 mg on Day 1 and Day 6.
15802811|NCT04428073|Biological|Covax-19™|Therapeutic vaccine for SARS-CoV-2 infection
15802812|NCT04428060|Other|PERSEUS CPR|Resuscitation based on patient physiology
15802814|NCT04428047|Drug|bintrafusp alfa|bintrafusp alfa will be administered by intravenous infusion over 60 minutes at a dose of 1200 mg on Day1 and Day15
15802815|NCT04428034|Behavioral|Learning Skills Together|Information provided in arm/group description.
15802816|NCT04428021|Drug|Standard Therapy Protocol (STP)|Standard Therapy Protocol according to the best evidence treatment recommended by the Regional Health System emergency committee
15802817|NCT04428021|Other|STP + Standard Plasma (SP)|Transfusion of three Standard Plasma Units (SP) on day 1,3,5 in addition to STP
15802818|NCT04428021|Other|STP + COVID-19 Convalescent Plasma (CP)|Transfusion of three SARS-Cov-2 neutralizing antibodies positive Plasma Units (CP) on day 1,3,5 in addition to STP
15802819|NCT04428008|Drug|Thymalfasin|Synthetic 28 amino acid peptide
15802820|NCT04427995|Device|OMNI surgical system|GATT + viscodilation
15802823|NCT04427969|Behavioral|prone position|to lay in prone position at least 12 hour in a day at ICU
15802824|NCT04427956|Procedure|Corneal crosslinking: CXL (UVA 9mW/cm2)|CXL treatment with UVA-radiation (9mW/cm2) with a 10 minute irradiation protocol.
15802825|NCT04427956|Drug|Isotonic riboflavin|CXL protocol with isotonic riboflavin
15802826|NCT04427956|Drug|Hypotonic riboflavin|CXL protocol with hypotonic riboflavin
15802827|NCT04427956|Procedure|Iontophoresis|CXL protocol with iontophoresis and ricrolin
15802828|NCT04427943|Procedure|revision surgery|The intervention is the planned revision surgery according to local guidelines.
15802829|NCT04427930|Biological|JOINTSTEM|Autologous Adipose Tissue derived MSCs
15802830|NCT04427930|Drug|Saline|Saline
15802831|NCT04427917|Drug|PF-06835919|PF-06835919 300 mg repeated doses
15802832|NCT04427917|Drug|Placebo|Placebo repeated doses
15802833|NCT04427904|Drug|Bupivacaine 0.5% with 1:200 000 epinephrine|Bupivacaine 0.5% with 1:200 000 epinephrine. Total volume 10mL for local infiltration before neck incision.
15802834|NCT04427904|Drug|Lidocaine 2% with 1:100 000 epinephrine|Lidocaine 2% with 1:100 000 epinephrine. Total volume 10mL for local infiltration before neck incision.
15802835|NCT04427878|Procedure|biopsies of subcutaneous adipose tissue|Two 4mm punch biopsies of subcutaneous abdominal or thight adipose tissue
15802836|NCT04427865|Drug|prophylactic lactoferrin daily|200 mg oral lactoferrin daily
15802837|NCT04427852|Dietary Supplement|30 day Daily consumption of 1 serving of beef|Beef patty will replace one of the participants protein servings each day for 30 days. Each serving is 114 grams of 90% lean ground sirloin given to participants as an uncooked frozen patty.
15802838|NCT04427852|Dietary Supplement|30 day Daily consumption of 1 serving of the vegatable protein source|Veggie patty will replace one of the participants protein servings each day for 30 days. No beef will be consumed during this period. The veggie patty is commercially available Morningstar veggie burger and is given to participants in commercial packaging as a frozen precooked patty.
15802839|NCT04427826|Drug|Morphine hydrochloride|A single open-label injection of morphine (T0) at the dose closest to that defined by the model (estimation by Bayesian method) from among the following 4 doses: 0.02; 0.04; 0.07 and 0.1mg/kg will be adminestred to the patients.
15802840|NCT04427813|Behavioral|questionaire to husband and wife|a form of questions will be asked to every partner
15802841|NCT04427787|Drug|Cabozantinib|Cabozantinib will be administered orally at a dose of 60 mg/day
15802842|NCT04427787|Drug|Lanreotide|Lanreotide will be administrated 120 mg injection every 28 days
15802843|NCT04427774|Drug|Surufatinib plus Sintilimab|Surufatinib will be given orally. Sintilimab will be given intravenously
15802844|NCT04427761|Behavioral|Measurement of Transitions in Cancer Scale (MOT-CA) Survey|These surveys will take 5-10 minutes to complete at two time-points, T0 (baseline) and T1 (four to six weeks after baseline visit) The patient will again complete the DT and MOT-CA at a chemotherapy treatment or clinic visit, if possible, or via a telephone call with the principal investigator in the event that there are no in-person visits scheduled (Time 1).
15802845|NCT04427761|Behavioral|Distress Thermometer Survey|These surveys will take 5-10 minutes to complete at two time-points, T0 (baseline) and T1 (four to six weeks after baseline visit).The patient will again complete the DT and MOT-CA at a chemotherapy treatment or clinic visit, if possible, or via a telephone call with the principal investigator in the event that there are no in-person visits scheduled (Time 1).
15802846|NCT04427709|Drug|Oxytocin|Intramuscular injection of Oxytocin (Pitocin®)
15802847|NCT04427709|Drug|Placebo|Intramuscular placebo injection
15802848|NCT04427696|Behavioral|Aerobic walking intervention|Walking exercise is self-controlled and tracked by daily dairy. All of the participants are obligated to record the start and end time of walking every day. And pedometers will be used for tracking walking steps including heart rate and calories. We plan to use pedometer in our study, which was reported the most accurate pedometer and suitable for scientific research. For the ones who are in the control group, they have to keep sedentary lifestyle, and no regular walking exercise, and they are agree to be in the comparable members in our study.
15802849|NCT04427683|Behavioral|Brief mindful parenting program|Mindfulness exercise include formal and informal mindfulness exercises, and additional exercise for coping with anger and arousing emotions. Psychoeducation includes understanding relationship between thoughts and feelings, fight or flight responses and adaptive coping in parenting relationship.
15802850|NCT04427670|Other|Group intervention|Group intervention programme designed for stroke survivors with dysarthria and their carers. The programme was eight weeks long, with weekly two sessions, each session lasting for two hours, lead by speech language therapist and was comprised of activities which addressed participants education about their dysarthria and stroke. The role of family , peer and professional was to provide support and communication practice.
15802851|NCT04427670|Other|Regular speech therapy|Regular speech therapy will be provided to the controlled group.Regular speech therapy is one to one speech therapy session,conducted twice a week for the duration of eight weeks.This intervention is implemented to patients with dysarthria following stroke in a format of one patient and one therapist per session.
15802918|NCT04427007|Device|Moisture Management Liner|A prototype liner designed to reduce and/or remove moisture and heat that builds up on the limb.
15802852|NCT04427657|Procedure|autologous microfragmented lipoaspirate tissue (Lipogems®).|patient in supine position. A double contemporary operating fields is made under sedation. During arthroscopic debridement is made an injection of local anesthetic at the dermal level with a subcutaneous infiltration of Klein solution. The plastic surgeon wait for about 5 minutes for vasoconstriction and then start with liposuction of about 60 ml of adipose tissue. Then lipoaspirate was processed with Lipogems® technique that consist in a mechanical fragmentation, physiological washing and filter passage of the lipoaspirate. A volume of 8-9 ml of microfragmented adipose tissue was injected intra-articulary after arthroscopic debridement.
15802853|NCT04427657|Procedure|arthroscopic debridment|patient in supine position. Under sedation is perform an arthroscopic debridement
15802854|NCT04427644|Procedure|Laparascopic Sleeve Gastrectomy|Operations performed for complciation of laparascopic sleeve gastrectomy
15802855|NCT04427644|Procedure|İnterventional radiologic drainage|İnterventional radiologic drainage of gastric leakage
15802856|NCT04427644|Diagnostic Test|Complte Blood Count and Biochemical evaluation|blood samples obtained from patients to determine the hgb and htc levels of patients and biochemical changes of patients after surgery
15802857|NCT04427644|Diagnostic Test|Computed tomography|Admitted to observe leakage
15802858|NCT04427631|Device|Bone conduction headphones|Children will be offered hearing support with bone conduction headphones that can either be paired to a microphone or to a tablet/ phone/ computer to help children to hear. The Hear Glue Ear app is available for free to provide speech and language enrichment.
15802859|NCT04427618|Drug|Tranexamic acid|Intravenous 1g TXA (500mg/5ml, given intermittent over approximately 10 minutes) given within approximately 10 minutes before skin incision
15802860|NCT04427618|Drug|Normal saline|Intravenous 10ml normal saline (placebo) given within approximately 10 minutes before skin incision
15802861|NCT04427592|Diagnostic Test|ultrasound|trans-vaginal and trans-abdominal ultrasound using different modalities such as grey-scale, Doppler, multi-planer mode
15802862|NCT04427592|Procedure|closure of uterine wall defect|uterine incision above placental bulge by at least 5 mm then complete separation of the placenta starting from areas of least resistance to areas of high resistance leaving a clear defect which will be closed by non locked running sutures from inside the uterus starting from one edge, hitch the bed to the other edge of the defect and controlling placental bed hemorrhage then closing the uterine incision via running sutures in 2 layers with compressing the bed from outwards in the first layer. hemostasis of the abnormal pelvic vasculature if excessive bleeding internal iliac artery may be ligated then insertion of intra-peritoneal drain followed by closing the abdomen.
15802863|NCT04427566|Radiation|Radiation therapy|Patients will be treated with a single dose of 80 cGy to the bilateral lungs in a manner that is simplified such that it can be designed and delivered quickly in one session. No specific normal tissue constraints are employed in this protocol.
15802864|NCT04427553|Device|Percutaneous Peripheral Nerve Stimulation|Participants assigned to this group will received two sessions (once per week) of ultrasound guided Percutaneous Peripheral Nerve Stimulation targeting the femoral nerve.
15802865|NCT04427553|Other|Control Group|No intervention
15802866|NCT04427540|Drug|Oxytocin|Oxytocin 10 micrograms IM
15802867|NCT04427527|Behavioral|Multi-level intervention to increase CRC screening|Intervention for the community, providers, patients, clinics and systems
15802868|NCT04427514|Device|Telemedicine software for data transmission and analysis in CAPD.|Telemedicine software is related to peritoneal dialysis. With the help of a tablet device running an Android system on patients and the care team and the smart devices attached to it (scales, blood pressure monitor), patients perform measurements in their homes in connection with solution changes. The resulting data is transmitted through the telemedicine system to the care team, which can take immediate intervention if necessary and notify the patient of any change in therapy.
15802869|NCT04427501|Drug|LY3819253|Administered IV or SQ
15802870|NCT04427501|Drug|LY3832479|Administered IV or SQ
15802871|NCT04427501|Drug|Placebo|Administered IV
15802874|NCT04427475|Drug|pabolizumab|100 patients with stage IV EGFR / ALK wild-type NSCLC (squamous cell carcinoma patients do not need to be detected) who received anti-PD-1 (pabolizumab) treatment combined with chemotherapy as the first-line treatment were enrolled in the center. Baseline plasma samples were collected before the treatment, and the efficacy was evaluated once every two treatment cycles. At the same time, plasma samples were collected at key nodes until the patient's progress.
15802875|NCT04427475|Drug|nafulizumab|nafulizumab
15802876|NCT04427449|Biological|CD44v6-specific CAR gene-engineered T cells|4SCAR-CD44v6 Infusion of 4SCAR-CD44v6 T cells at 10^6 cells/kg body weight
15802877|NCT04427436|Other|No Intervention|No Intervention
15802878|NCT04427423|Other|physical therapy treatment|the experimental group received positional distraction plus stabilization exercises and the control group received stabilization exercises only.
15802879|NCT04427410|Diagnostic Test|Salivary test|Salivary test for measured of oxytocin levels
15802880|NCT04427397|Other|Sulcular Bristle Tip Technique (SBTT)|Tooth brushing should begin on the distal of the most posterior tooth on one side of the mouth and proceed anteriorly and then posteriorly overlapping areas to the most distal surface of the most posterior tooth on the contra lateral side. The lingual is done in like fashion ending where the brushing began. The opposing arch is brushed in the same manner. When moving from one area to the next, disengage the brush bristles entirely off the teeth to allow them to straighten, and then reposition the brush in the next overlapping area. Do not to drag the bristle tips from one area to the next area. For the lingual of the anterior teeth, the narrow portion of the brush is used with the exact same technique as described above. For the lingual of the mandibular molars, the angulation of the toothbrush bristles to the tooth needs to be somewhat more perpendicular to the tooth than on the buccal to ensure that the bristle tips enter the gingival crevice.
15802881|NCT04427384|Device|GammaTile|Surgically Targeted Radiation Therapy
15802882|NCT04427371|Other|the levels of pyroptosis|Blood samples were taken to detect plasma lncRNA NBR2 levels and GSDMD protein level.
15802883|NCT04427345|Other|Predictive factors for clinical response in patients with COVID-19.|Identify the risk factors for intra-hospital mortality in patients hospitalized in the COVID + hospital wards of the San Gerardo hospital and build a prognostic score through which it is possible to define a stratification that immediately guides the therapeutic choices and the intensity of care .
15802884|NCT04427332|Other|Investigation of smell and taste disorders|The study consists of an epidemiological investigation by means of a prospective observational study with the aim of investigating the demographic and clinical factors related to the sense of smell and taste in patients with Sars Cov 2 infection.
15802885|NCT04427319|Dietary Supplement|β-alanine|7 days of consumption
15802886|NCT04427319|Dietary Supplement|wheat semolina|7 days of consumption
15802887|NCT04427306|Drug|T-Vec|T-Vec will be given prior to surgery
15802888|NCT04427293|Drug|Lenvatinib|One 21-day cycle of therapy prior to surgery, consisting of lenvatinib 12 mg daily, days 1 through 14
15802889|NCT04427293|Drug|Pembrolizumab|One 21-day cycle of therapy prior to surgery, consisting of pembrolizumab 200 mg IV on day 1
15802890|NCT04427267|Other|Personal protective equipment from biological hazard|Includes: isolation clothing, mask, eyewear, overshoes
15802891|NCT04427254|Drug|Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies|Cerebrospinal fluid sampling, meningeal and brain parenchyma biopsies
15802892|NCT04427241|Drug|Amantadine Sulfate plus Cerebrolysin|Amantadine plus cerebrolysin : amantadine 100mg to 200mg bid plus cerebrolysin 30ml qd
15802893|NCT04427241|Drug|Amantadine Sulfate|Amantadine only : amantadine 100mg to 200mg bid
15802894|NCT04427241|Drug|Cerebrolysin|Cerebrolysin only : cerebrolysin 30ml qd
15802895|NCT04427228|Radiation|Radiosurgery Single Treatment|Frameless single-fraction SRS. One large treatment done on each brain tumor. 20 Gy for GTVs (or resection cavity CTVs) < 2 cm, and 18 Gy for GTVs (or resection cavity CTVs) between 2-3 cm in the single-fraction.
15802896|NCT04427228|Radiation|Radiosurgery Three Treatments|Multi-fraction SRS. Three small doses done on each brain tumor. 27 Gy in 3 fractions in the multi-fraction group
15802897|NCT04427215|Other|Complementary and alternative medicines|Five types of Complementary and alternative medicines (Music Therapy, Art Therapy, Dance-Movement Therapy, Bibliotherapy, Physical Activity) will be applied twice a week.
15802898|NCT04427202|Behavioral|Referral to harm reduction services|Participants are referred to harm reduction services
15802899|NCT04427176|Device|ARFC mask|Nurse will wear the ARFC mask during working days. The total duration of the study will be 48 hours for each participant, 2 consecutive working days of 8 or 12 hours.
15802900|NCT04427163|Genetic|Blood sample analysis|Nucleic acids sequencing, presence of proteins and metabolites.
15802901|NCT04427163|Other|Health status|Health status will be examined by a physician and subject will complete a health status questionnaire.
15802902|NCT04427163|Other|Race and ethnicity|Subject will complete race and ethnicity questionnaire to make sure subjects are from the Czech population.
15802903|NCT04427150|Behavioral|Auditory Training|A series of psychoacoustic training exercises through Posit Science - BrainHQ (mobile app or web-browser version). Each training is approximately 2 minutes
15802904|NCT04427150|Behavioral|Non-auditory training|A series of non-psychoacoustic training exercises through Posit Science - BrainHQ (mobile app or web-browser version). Each training is approximately 2 minutes
15802905|NCT04427137|Device|MagPro X100 Stimulator, B70 Fluid-Cooled Coil|Treatment will occur 8 times per treatment day (50 min pause between treatments). Each treatment session will consist of a single LFR treatment, with 360 pulses of LFR delivered in one continuous train of 6 minutes at 1Hz at 120% of the patient's resting motor threshold.
15802906|NCT04427124|Other|Multidisciplinary Team Based Care Model|All prospective patients admitted into the study will receive care based on multidisciplinary team collaboration and an institutional protocol for critical limb ischemia.
15802907|NCT04427111|Device|Non-titratable-customized mandibular advancement device|The most comfortable protruded mandibular position situated between 60-75% of MMPV was determined according to patient response with 6mm of the vertical interocclusal dimension between maxillary and mandibular central incisors and registered. The upper and lower acrylic resin splints were secured to each other in the posterior region with auto polymerizing acrylic resin and NTC-MADs were obtained. The patients were instructed to wear their non-titratable-customized mandibular advancement device every night.
15802908|NCT04427098|Drug|Enoxaparin 40 Mg/0.4 mL Injectable Solution|Subcutaneous enoxaparin 40 mg once daily for 14 days.
15802909|NCT04427098|Drug|Enoxaparin|Subcutaneous enoxaparin for 14 days: 60 mg once daily in case of body weight of 45 to 60 kg; 80 mg once daily in case of weight from 61 to 100 kg; 100 mg once daily in case of bodyweight >100 kg
15802910|NCT04427085|Other|Ultrasound assessment of optic nerve sheath diameter|Using ultrasonography, optic nerve sheath diameter is measured during perioperative period.
15802911|NCT04427072|Drug|Capmatinib|400mg of capmatinib tablets administered orally twice daily
15802912|NCT04427072|Drug|Docetaxel|Docetaxel 75 mg/m2 by intravenous infusion every 21 days
15802913|NCT04427059|Procedure|Transversus Abdominis Plane (TAP) block|"The laparoscopic-assisted Transversus Abdominis Plane (TAP) block will be done just after the optic trocar placement as follow: as landmarks we use the anterior axillary line, in the middle between the iliac crest and the costal margin. After insertion of the optic trocar the peritoneum is visualized. A 14 Gauge needle is inserted 2 cm cranially respect the taken landmark through the skin until the penetration of the internal and external oblique fascias, identified as sudden lowering of resistance. Laparoscopy allows to confirm that the needle did not pass the peritoneum.
~A solution of 20 ml of Ropivacaine (0.25%) is then injected, observing the formation of a bulge posterior to the transversus abdominis muscle.
~The procedure is then repeated identically on the contralateral side."
15802914|NCT04427059|Procedure|Port-Site Infiltration (PSI)|The Port-Site Infiltration (PSI) will be performed by infiltrating the subcutis and the skin at the trocar site before the trocar placements with a solution of local anesthetic (Ropivacaine 0.25%), a total of 40 ml will be administered.
15802915|NCT04427033|Device|Bone Conduction Implant|Bonebridge system BCI 602
15802916|NCT04427020|Dietary Supplement|Milk protein + GBI-30|Both conditions matched flavor, color, and serving size
15802917|NCT04427020|Dietary Supplement|Milk protein|Both conditions matched flavor, color, and serving size
15803003|NCT04426409|Drug|tarivid ointment|Vaseline ointment is applied to both noses.
15802919|NCT04427007|Device|ICE Socket Cooling System|The ICE Socket Cooling System is a battery-powered cooling device for lower-limb amputees.
15802920|NCT04426994|Drug|proton pump inhibitor use|Patients using long term proton pump inhibitor
15802921|NCT04426981|Behavioral|Behavioral Activation|Behavioral activation is a behavioral treatment that focuses on helping participants engage in more rewarding and enjoyable activities. In the first session, participants will begin to identify domains of their life which are important to them. In the second session, participants will be assisted in creating an action plan to engage in more activities in one or more domains of importance. In session 3-8, participants will be assisted in problem solving any challenges they encountered in implementing their previous action plan and will develop a new action plan. The intervention will continue until participants achieved three action plans or reach the eight-session limit, whichever comes first.
15802922|NCT04426968|Drug|Hepalatide 2.1mg|2.1 mg/day subcutaneously (s.c.) for 24 week
15802923|NCT04426968|Drug|Hepalatide 4.2mg|4.2mg/day subcutaneously (s.c.) for 24 week
15802924|NCT04426968|Drug|Hepalatide 6.3mg|6.3mg/day subcutaneously (s.c.) for 24 week
15802925|NCT04426968|Drug|placebo 2.1mg|2.1 mg/day subcutaneously (s.c.) for 24 week
15802926|NCT04426968|Drug|placebo 4.2mg|4.2 mg/day subcutaneously (s.c.) for 24 week
15802927|NCT04426968|Drug|placebo 6.3mg|6.3 mg/day subcutaneously (s.c.) for 24 week
15802928|NCT04426968|Drug|Pegylated Interferon|180 ug/week subcutaneously (s.c.) for 28 week
15802929|NCT04426955|Drug|Camrelizumab|IV infusion
15802930|NCT04426955|Drug|Paclitaxel|IV infusion
15802931|NCT04426955|Drug|Cisplatin|IV infusion
15802932|NCT04426955|Drug|Placebo|IV infusion
15802933|NCT04426955|Radiation|Radiation|Concurrent Radiation
15802934|NCT04426942|Other|survey|survey on sexuality during pregnancy
15802938|NCT04426916|Other|Spondylolisthesis|Spondylolisthesis at a single level
15802939|NCT04426903|Other|webFitForAll|PT training participants use the webFitForAll exergaming computer platform as the physical training component (PT)
15802940|NCT04426903|Other|BrainHQ|CT training participants use the language adapted version of the BrainHQ program as the cognitive training component (CT)
15802941|NCT04426890|Biological|CT-P39|Prefilled syringe (PFS) of 1 mL solution
15802942|NCT04426890|Biological|EU-approved Xolair|Prefilled syringe (PFS) of 1 mL solution
15802943|NCT04426877|Behavioral|Experimental group|The self-applied online program will comprise a three months behavioural intervention composed by 9 modules seeking to develop gradually achieving the goals of changing eating and physical activity habits, supported by audiovisual instructions. This group will receive access to the web-based lifestyle intervention (exercise and nutritional education), supported by audiovisual instructions given by their hypertension specialist doctor.
15802944|NCT04426877|Behavioral|Control group|The self-applied online program will comprise a three months behavioural intervention composed by 9 modules seeking to develop gradually achieving the goals of changing eating and physical activity habits, supported by audiovisual instructions. This group will receive the same web-based lifestyle intervention (exercise and nutritional education), but in this case supported by audiovisual instructions given by a doctor outside the patient.
15802945|NCT04426864|Other|Supervised Aerobic Plus Stretching Exercises|An exercise prescription was developed for each woman based on the data acquired from the baseline treadmill exercise test. Target HR corresponding to values of 50-70 % ergospirometric VO2max (moderate-intensity) was determined by the submaximal treadmill test. The participants were instructed to perform their exercises at 50 % of VO2max for six weeks. At seventh their exercise intensity was increased to target HR corresponding to 70 % of VO2max. HR was monitored by a Polar HR monitor (Polar Beat, Port Washington, NY). Stretching exercises were performed at the beginning and end of each exercise session. Each muscle group exercise was performed 3-4 times and each repeat was 30 seconds long. The muscle groups which were involved in stretching exercises were upper trapezius, rhomboid, hip flexor, hamstring, pectoral, piriformis, quadriceps, gastrocnemius, soleus, levator scapulae, hip adductor and tensor fasciae late muscles. The exercise program was applied 3 days a week for 12 weeks.
15802946|NCT04426864|Other|Supervised Resistance Plus Stretching Exercises Group|According to the data obtained from 1-RM tests, an exercise prescription was developed for each woman. The participants were instructed to perform their exercises with 50% of 1-RM for six weeks. In the 7. week, weights were increased to 70-80% of 1-RM. The number of sets increased progressively (10 repetitions per set; 1 set in the first two weeks; 2 sets in the 3rd and 4th week; 3 sets in the 5th and 6th week). The muscle groups which were involved in resistance exercises were bilateral biceps, deltoid, trapezius, pectorals, serratus anterior, latissimus dorsi, levator scapulae, rhomboid, gluteal, quadriceps, hip adductor and abductor, hamstring, gastrocnemius and abdominal muscles. Stretching exercises were performed at the beginning and end of each exercise session. Each muscle group exercise was performed 3-4 times and each repeat was 30 seconds long. Stretching exercises were given for the muscle groups they worked on. The exercise program was applied 3 days a week for 12 weeks.
15802947|NCT04426864|Other|Home-based Stretching Exercises Group|Each exercise was described to the patient by visually. For each muscle group exercise was performed for 3-4 times and each repeat was 30 seconds long. The muscle groups which were involved in stretching exercises were upper trapezius, rhomboid, hip flexor, hamstring, pectoral, piriformis, quadriceps, gastrocnemius, soleus, levator scapulae, hip adductor and tensor fasciae late muscles. Exercise program was applied 3 days in a week during 12 weeks. Each participant was called every 2 weeks to maintain compliance.
15802948|NCT04426851|Drug|BI 1358894|BI 1358894
15802949|NCT04426838|Behavioral|Cognitive Behavioral Therapy for Insomnia (CBTi) via Videoconference|The CBTi protocol will include stimulus control, sleep compression, relaxation, sleep hygiene, and cognitive restructuring which will be done over 4 weeks with one session weekly delivered via videoconference.
15803004|NCT04426370|Other|Observational|Physical examination and questionnaires
15802952|NCT04426812|Other|No intervention; just data collection|No intervention; just data collection
15802953|NCT04426799|Other|lemon essential oil|A randomized, pre-test-post-test design was carried out to examine the effectiveness of lemon essential oil in reducing test anxiety in first-year students of the Faculty of Medical Sciences of a private university in Istanbul
15802954|NCT04426786|Other|Active exercise|Thrice-weekly supervised intense aerobic exercise classes on cycle ergometers, in groups, for six months. Percentage of VO2 max will be used to regulate exercise intensity, based on an initial aerobic exercise test.
15802955|NCT04426786|Other|Passive exercise|Thrice-weekly supervised passive exercise classes consisting of stretching and/or yoga, in groups, for six months.
15802956|NCT04426773|Device|High-Definition transcranial direct current stimulation|The tDCS device will deliver a direct current of 1.5mA for 20 minutes. Cathode electrode will be localized in front of the OFC on the Fp2 point according to the EEG international reference. Four anode electrodes will be placed around FP2 (i.e. Fpz, AFz, AF4, AF8).
15802957|NCT04426760|Procedure|Transcervical resection of fibroids|Transcervical resection of fibroids
15802958|NCT04426760|Procedure|Myomectomy per laparoscopy or laparotomy|Myomectomy per laparoscopy or laparotomy
15802959|NCT04426747|Other|No intervention|No intervention
15802960|NCT04426734|Device|Dextenza Dexamethasone Implant|The area of the punctum is first anesthetized with eye drops. A localized injection of lidocaine in perform once the surface of the punctum is numbed with the eyedrop. After 5-10 minutes, the corner of the eyelid and the region of the punctum will be fully anesthetic. The upper and lower punctum are then dilated with a punctum dilator to facilitate the insertion of the DEXTENZA medication. The DEXTENZA medication is then inserted using smooth forceps into the dilated opening of the upper and lower punctum. Once the DEXTENZA is inserted into the both the upper and lower punctum, the procedure is down. No repeated insertion of the DEXTENZA is required for the study.
15802961|NCT04426734|Drug|Topical Prednisolone Acetate 1%|"Topical corticosteroid (Pred Forte, prednisolone acetate 1%) standard of care tapered treatment regimen of
~8x/day week 1 4x/day week 2 2x/day week 3
~1x/day week 4
~Visit schedule: Baseline, Day 3, Day 7, Day 14, and Day 30"
15802962|NCT04426721|Drug|Ozone|10 cc of oxygen-ozone
15802963|NCT04426721|Drug|Hyaluronic Acid|Sinovial forte 32 mg\2ml
15802964|NCT04426708|Drug|HMS5552|single dose of HMS5552 25mg
15802965|NCT04426695|Drug|REGN10933+REGN10987 combination therapy|Administered intravenously (IV) single dose
15802966|NCT04426695|Drug|Placebo|Placebo IV Single Dose
15802967|NCT04426682|Diagnostic Test|urodynamics parameters|"Urodynamics evaluation is performed in the preoperative period in patients whose operation is planned due to incontinence.
~Urodynamics evaluation is performed again in patients who applied with postoperative relapse due to surgery failure or different reasons.
~It will be shown whether there is a difference between the urodynamics parameters of preoperatively examined patients and those of urodynamics examined in case of postoperative failure."
15802968|NCT04426669|Drug|Cyclophosphamide|Day -6 and Day -5: Cyclophosphamide 60 mg/kg/dose as a 2 hour intravenous infusion with Mesna 15 mg/kg/dose, 1st dose prior to Cyclophosphamide infusion then at 3,6,9 and 12 hours later.
15802969|NCT04426669|Drug|Fludarabine|Day -7 to Day -3 : Fludarabine 25 mg/m^2/dose as a 1 hour intravenous infusion per institutional guidelines once a day for 5 doses beginning on Day -7. Fludarabine will be started approximately 1 to 2 hours after the cyclophosphamide on Day -6 and Day -5.
15802970|NCT04426669|Biological|Tumor-Infiltrating Lymphocytes (TIL)|Day 0 : Each bag of autologous CISH inactivated TIL for infusion will be administered intravenously (IV) on the Patient Care Unit over 10-20 minutes at assigned dose level.
15802971|NCT04426669|Drug|Aldesleukin|Days 1-4 : Aldesleukin at 720,000 U/kg as an intravenous infusion, every 8 -12 hours but, no more than 24 hours apart as tolerated for up to 6 doses.
15802972|NCT04426656|Behavioral|Phone application|"The mini-app (used in Part 2) has four main functions:
~a knowledge center that contains a series of HIV-, sexual health-, and PrEP-related educational articles in Chinese;
~an HIV self-test toolkit ordering system that allows users to order a finger-prick HIV rapid test toolkit and shipped to home for free (one piece at a time);
~an asynchronous message function that allows users to chat with a study staff (C.Li); and
~a user profile page where users can manage all HIV test orders."
15802973|NCT04426643|Biological|Autologous adipose-derived mesenchymal stem cells|Autologous adipose-derived mesenchymal stem cells mixed with collagen solution injected in submucosal space
15802974|NCT04426643|Other|Standard treatment according to the Clinical protocols|Standard treatment according to the Clinical protocols
15802975|NCT04426630|Other|mHealth for heart failure patients in Uganda|Patients at Uganda Heart Institute will be enrolled in an mHealth program intended to promote self-care for heart failure and improve their healthcare quality of life.
15802976|NCT04426617|Procedure|Ultrasound Guided Transversus Abdominis Plane Block|The patient will lie in the supine position. The transducer will be placed in the axial plane on the mid-axillary. transversus abdominis muscle will be visualized. A skin wheel using 3 ml of lidocaine 1 % is made 2 to 3 cm medial to the medial aspect of the transducer and the 22 gauge is inserted in-plane pointing laterally. Then Injection of local anaesthetic mixure in the right plane.
15802977|NCT04426604|Diagnostic Test|Light induced fluorescence intraoral camera|Each restoration margins will be assessed by Light induced fluorescence intraoral camera to assess its validity in diagnosing secondary caries around margins of resin composite restorations
15802978|NCT04426604|Diagnostic Test|Laser-induced fluorescence device|Each restoration margins will be assessed by Laser-induced fluorescence device to assess its validity in diagnosing secondary caries around margins of resin composite restorations
15802979|NCT04426604|Diagnostic Test|Visual-tactile assessment method according to FDI criteria|Each restoration margins will be assessed by visual-tactile assessment method which includes the use of mirror, probe under good illumination condition to assess its validity in diagnosing secondary caries around margins of resin composite restorations
15803005|NCT04426357|Drug|JNJ-64417184|Participants will receive single oral (as film coated tablet) dose of JNJ-64417184 on Day 1.
15803068|NCT04425876|Drug|Fluzoparib|Fluzoparib combined with mFOLFIRINOX followed by maintenance Fluzoparib monotherapy
15803268|NCT04424251|Drug|Placebo 1 μg/kg|Once preoperative and once each at 0, 8, and 16 h postoperative, for a total of 4 administrations
15802980|NCT04426591|Drug|Biotin Labeled Red Blood Cells|On the day of transfusion, a 20 mL aliquot will be sterilely withdrawn from each RBC unit, washed and labeled with sulfo-NHS-biotin for 30 minutes, washed to stop the labeling reaction, then resuspended in plasma to a hematocrit of ~60%. The biotin-labeled RBC (BioRBC) will be transfused along with the remainder of the RBC unit (unlabeled volume). Standard blood bank and CTT protocols and minor antigen matching for SCD patients will be followed. Exact transfusion volume will be determined based on pre-transfusion Hb, HbS, and body weight, per clinical protocol.
15802981|NCT04426578|Drug|Perhexiline|"All eligible and consented patients will be randomised to initiation of perhexiline 100mg once daily or identical placebo. After 4 days of treatment, a blood sample will be collected to determine plasma perhexiline concentrations: timing of the sample need not be trough in view of the long-acting nature of perhexiline. Depending on the blood results, patients might require as little as 50mg/week (slow metabolisers) or as much as 600mg/day (ultra-rapid metabolisers). The initial sample will be utilized primarily to detect presence of hydroxylated metabolite: patients in whom perhexiline is detected in the absence of metabolite will be designated slow metabolisers and will have their dosage reduced to 50 mg/week in the first instance. Repeat assay at 30 days will be utilized for individual finer dose titration based on dose adjustment table. Paired dosage adjustment in placebo-treated patients will be performed to avoid unblinding.
~Compliance will be assessed by capsule count."
15802982|NCT04426578|Other|Placebo|"All eligible and consented patients will be randomised to initiation of perhexiline 100mg once daily or identical placebo. After 4 days of treatment, a blood sample will be collected to determine plasma perhexiline concentrations: timing of the sample need not be trough in view of the long-acting nature of perhexiline. Depending on the blood results, patients might require as little as 50mg/week (slow metabolisers) or as much as 600mg/day (ultra-rapid metabolisers). The initial sample will be utilized primarily to detect presence of hydroxylated metabolite: patients in whom perhexiline is detected in the absence of metabolite will be designated slow metabolisers and will have their dosage reduced to 50 mg/week in the first instance. Repeat assay at 30 days will be utilized for individual finer dose titration based on dose adjustment table. Paired dosage adjustment in placebo-treated patients will be performed to avoid unblinding.
~Compliance will be assessed by capsule count."
15802983|NCT04426565|Behavioral|motivational enhancement interview|Motivational interviewing is supported by over 200 randomized controlled trials across a range of target populations and behaviors including substance abuse, health-promotion behaviors, medical adherence, and mental health issues.
15802984|NCT04426565|Behavioral|the individual psychotherapy|It has been demonstrated to be an effective treatment for depression and has been modified to treat other psychiatric disorders such as substance use disorders and eating disorders. It is incumbent upon the therapist in the treatment to quickly establish a therapeutic alliance with positive countertransference of warmth, empathy, affective attunement and positive regard for encouraging a positive transferential relationship, from which the patient is able to seek help from the therapist despite resistance.
15802985|NCT04426565|Behavioral|the group psychotherapy|Group psychotherapy is a key component of milieu therapy in a therapeutic community. The total environment or milieu is regarded as the medium of therapy, all interactions and activities regarded as potentially therapeutic and are subject to exploration and interpretation, and are explored in daily or weekly community meetings. A form of group therapy has been reported to be effective in psychotic adolescents and recovering addicts.
15802986|NCT04426565|Behavioral|the family therapy|"According to a 2004 French government study conducted by French Institute of Health and Medical Research, family and couples therapy was the second most effective therapy after Cognitive behavioral therapy. The study used meta-analysis of over a hundred secondary studies to find some level of effectiveness that was either proven or presumed to exist. Of the treatments studied, family therapy was presumed or proven effective at treating schizophrenia, bipolar disorder, anorexia and substance dependence."
15802987|NCT04426552|Drug|dexmedetomidine|will have a bolus of dexmedetomidine one μg/kg (Precedex; Hospira, Inc, Lake Forest, IL) administered for 10 minutes, followed by a continuous infusion at 0.7 μg • kg-1 • h-1 during FOI
15802988|NCT04426552|Drug|sevoflurane|preoxygenated using face mask with 100% oxygen for 3 min to increase oxygen reserve and then inhalational induction will be started with sevoflurane in 100% oxygen using Ayre's piece circuit/MapelsonD circuit according to age and weight of the patient while performing fiberoptic intubation
15802989|NCT04426526|Device|BTL 799-2|High power magnet system
15802990|NCT04426513|Other|Kinesiotherapy with magnetotherapy|Individual kinesiotherapy. Parameters of magnetic field: 7 mT, f= 0-50 Hz, type of impulse: unipolar or bipolar, rectangular pulse
15802991|NCT04426500|Drug|Bupivacain|Direct injection of 0.25% bupivacaine into surgical wounds
15802992|NCT04426500|Drug|Ultrasound-guided transversus abdominus plane block|bilateral TAP using ultrasound guidance in prostatectomies
15802993|NCT04426500|Drug|Laparoscopic-guided transversus abdominus plane block|bilateral TAP using laparoscopic guidance in prostatectomies
15802994|NCT04426487|Drug|Progesterone|Intramusculer progesterone
15802995|NCT04426474|Drug|LY3502970|Administered orally.
15802996|NCT04426474|Drug|Placebo|Administered orally.
15803000|NCT04426448|Behavioral|Brief Relaxation, Education And Trauma HEaling|A three-week psychological intervention for PTSD which comprise psychoeducation and breathing retraining to manage anxiety symptoms
15803001|NCT04426435|Drug|honey based (HB) syrup|"honey-based syrup is prepared according to the documented Persian Medicine manuscripts with some modifications. HB is a mixture of honey, rose water and saffron. Each 100g of HB consisted of 79.87 g honey, 19.97 g rose water, and 0.16 g saffron.
~All the ingredients were licensed and approved by The Islamic Republic of Iran Food and Drug Organization (I.R.I.FDO)."
15803002|NCT04426422|Drug|Metformin Hydrochloride|treated with metformin 1500-2000mg daily
15803006|NCT04426344|Device|ensoETM device|Core warming will be performed using standard technique per instructions for use for the esophageal heat transfer device. The esophageal heat transfer device will be set to 42°C temperature after initial placement, and maintained at 42°C for the duration of treatment. It is expected that patient temperature will increase from baseline by 1°C to 2°C, but due to ongoing heat loss from the patient, the expected maximum patient temperature is below 39°C. The time course of illness of COVID-19 is such that most patients no longer have fever by the time of mechanical ventilation.[41] If patient temperature increases above this range and reaches 39.8°C, the device will be set to an operating temperature of 40°C, thereby preventing any further increase in patient temperature (ambient heat loss precludes patient from reaching device operating temperature).
15803007|NCT04426331|Behavioral|Voucher Without Value Information|"Patients being referred for follow-up received standard materials, counseling, and reminders as in the 'no information' group and were provided with a physical voucher they were told is redeemable for free follow-up appointment at Johns Hopkins Hospital. The voucher included the patient's name, the screener's name, and an expiration date 90 days from the date of screening.
~These participants were told: I am going to give you this voucher for a completely free appointment and a free pair of glasses if you need them. So, with this voucher, both the exam and the glasses will be completely free."
15803008|NCT04426331|Behavioral|Voucher With Value Information|"Patients being referred for follow-up received standard materials, counseling, and reminders as in the 'no information' group and were provided with a physical voucher they were told is redeemable for free follow-up appointment at Johns Hopkins Hospital, which would normally cost $250. The voucher included the patient's name, the screener's name, an expiration date 90 days from the date of screening, and a statement about the $250 voucher value.
~These participants were told: I am going to give you this voucher for a completely free appointment and a free pair of glasses if you need them. These services normally cost about $250, but with this voucher, both the exam and the glasses will be completely free."
15803009|NCT04426318|Behavioral|Healthy Minds Program Foundations Training|The HMP is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. The program is unique in several ways. First, all program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). Second, in addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.
15803010|NCT04426305|Other|community health worker support|usual care by professional primary care providers + emotional support by trained community health worker
15803011|NCT04426305|Other|care as usual|care as usual is provided by professional primary care provider
15803012|NCT04426292|Diagnostic Test|Serological testing|Antibody testing for Sars-COV-2 antibodies in blood.
15803013|NCT04426279|Other|questionnaire assesment|15-minute face-to-face questionnaire
15803014|NCT04426240|Drug|Cyclosporine microemulsion|Intervention group receives topical cyclosporine dry eye treatment before cataract surgery
15803015|NCT04426227|Other|Gaze training|A training module in gaze training for peripheral nerve blockade
15803016|NCT04426227|Other|Discovery learning|A phase of discovery learning guided by novice operators themselves
15803017|NCT04426214|Device|tDCS|We will apply tDCS in combination with cognitive training. All participants receive cognitive training, and will be randomized to receive either active or sham tDCS
15803018|NCT04426214|Behavioral|Cognitive Training|cognitive training on computer
15803019|NCT04426201|Drug|CYT107|IM administration at 10µg/kg twice a week for three weeks and up to 7 administrations according to Hospital length of stay
15803020|NCT04426201|Drug|Placebo|Same number, volume and frequency of IM administration of saline
15803021|NCT04426188|Procedure|Heading series|10 headers from machine-projected soccer balls at standardized speeds
15803022|NCT04426188|Device|Magnetic Resonance Imaging (MRI)|Brain MRI before and after a series
15803023|NCT04426188|Other|Cognitive computerized assessment|Cognitive evaluation carried out with two computerized tools
15803024|NCT04426188|Procedure|Electrophysiological records|Electrophysiological recording of Motor Evoked Potentials consisting of the application of transcranial magnetic stimulations (TMS) and the collection of muscle activity by electromyogram (EMG)
15803025|NCT04426188|Device|Dynamometer|Measure of the strength of the neck muscles using a dynamometer
15803026|NCT04426175|Device|2D and 3D cutting method using a low energy Femtosecond laser LDV Z8 for LASIK flap cutting|2D and 3D cutting methods were randomly used in same subjects
15803027|NCT04426162|Other|Multi-domain Intervention|Intervention includes neurofeedback, heart rate variability biofeedback, memory and cognitive training, and one-on-one coaching to encourage behavior change in diet, sleep, physical fitness, and stress reduction.
15803028|NCT04426149|Dietary Supplement|trehalose|patients were instructed to ingest 100g of oral trehalose diluted in 500ml of water or other beverages daily
15803029|NCT04426123|Drug|Botulinum toxin type A|Intramuscular injection with Botulinum toxin type A in m.masseter and m.temporalis.
15803030|NCT04426123|Other|saline solution|Intramuscular injection with NaCl in m.masseter and m.temporalis.
15803031|NCT04426097|Procedure|Cervical Vagal Blockade|Cervical Vagal Blockade with 0.5 % ropivacaine 2.5 ml and 2% xylocaine 2.5 ml
15803032|NCT04426097|Procedure|Without Blockade|Without Blockade
15803033|NCT04426084|Other|Hypertension|Exposure : Any registered diagnosis of I10 within 15 years or a registered pick-up of a prescription of antihypertensive treatment (ATC C02CA, C02DB02, C03, C07, C08, C09) within one year before index date in the Swedish prescribed drug register (exluding those with a registered diagnosis of other indications for betablocker (heart failure, atrial fibrillation) or ACE-inhibitor, ARB(heart failure) ) Exposures will be compared between cases and controls and between cases with different outcomes and controls
15803034|NCT04426084|Other|Diabetes type 2|"Exposure: Any registered diagnosis of E11 within 15 years or a registered pick-up of a prescription with any antidiabetic treatment (ATC A10) within one year before index date in the Swedish prescribed drug register.
~Exposures will be compared between cases and controls and between cases with different outcomes and controls"
15803035|NCT04426084|Other|Obesity|Exposure: Diagnosis ICD E66 within 15 years before index date Exposures will be compared between cases and controls and between cases with different outcomes and controls
15803036|NCT04426084|Drug|Antihypertensive Agents|"Pick up of a prescription of C02CA, C02DB02, C03, C07, C08, C09 registered in the Swedish prescribed drug register within 6 month before index date.
~Exposures will be studied separately for each antihypertensive class and compared between cases and controls and between cases with different outcomes and controls"
15803037|NCT04426084|Drug|Statins (Cardiovascular Agents)|Pick up of a prescription of C10AA registered in the Swedish prescribed drug register within 6 month before index date.
15803038|NCT04426058|Drug|CMP|Cluneal nerve Block 0.25% bupivacaine 20ml Pericapsular Nerve group block 0.25% Bupivacaine 20ml Lateral femoral cutaneous Block 0.25% bupivacaine 10ml
15803039|NCT04426058|Drug|Fascia Illica|Fascia iliaca block suprainguinal technique 0.25% bupivacaine 50ml
15803040|NCT04426045|Procedure|Pericapsular nerve group block|A curvilinear 2-5MHz ultrasound probe will be initially placed in a transverse plane over the anterior superior iliac spine and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the iliopubic eminence, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be observed. A 22-gauge, 80-mm needle will be inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. A total volume of 20 ml of ropivacaine 0.2% will be injected.
15803041|NCT04426045|Procedure|Supra-inguinal fascia iliaca compartment block|"A linear 6-13-MHz ultrasound probe will be placed in the sagittal plane to obtain an image of the anterior superior iliac spine. The fascia iliaca and sartorius, iliopsoas, and oblique internal muscles will be identified by sliding the probe medially. After identifying the bow-tie sign formed by the muscle fascias, a 22-gauge, 80-mm needle will be introduced 1 cm cephalad to the inguinal ligament. Using an in-plane approach, the fascia iliaca will be penetrated and hydrodissected, separating the fascia iliaca from the iliac muscle. A total volume of 30 ml of ropivacaine 0.2% will be injected."
15803042|NCT04426032|Diagnostic Test|Renal Doppler Ultrasound|Measurement of Renal resistive index
15803043|NCT04426019|Behavioral|CLS Intervention|Promotoras will deliver the CLS program either in face-to-face and/or group sessions to all women within 2 months of the baseline interview. Each session will last approximately 1 to 2 hours, and will include CLS materials adapted for this study.At the conclusion of the CLS program, promotoras will provide information about local and affordable providers delivering low-cost or free breast and cervical cancer screening services. Should a woman require follow-up for abnormal results, referrals will be given to programs,which provides assistance accessing cancer diagnostic and treatment services. Two weeks after delivering the education component of the CLS program, promotoras will call women to provide any further assistance needed. During these follow-up calls promotoras will provide on-going navigation support to women in need of mammography and Pap test screening
15803044|NCT04426019|Behavioral|No CLs intervention|This control arm will receive only usual practice care and will not receive the CLS intervention.They may receive the intervention after study has been completed
15803045|NCT04426006|Other|PRO-SERO-COV|"At inclusion, 3 months and 12 months :
~blood sample (2 x 5ml)
~self-administered questionnaire"
15803046|NCT04425993|Drug|Isosorbide Dinitrate 5 MG|All patients without contraindications should receive sublingual isosorbide dinitrate tablet within 5 minutes before ERCP.
15803047|NCT04425993|Drug|Indomethacin 100 MG|All patients without contraindications should receive rectal indomethacin within 30 min before ERCP.
15803048|NCT04425993|Drug|Sublingual Placebo|All patients without contraindications should receive sublingual placebo within 5 minutes before ERCP.
15803049|NCT04425993|Drug|Rectal placebo|All patients without contraindications should receive rectal placebo within 30 min before ERCP.
15803050|NCT04425980|Other|Modified Constraint-Induced Movement Therapy|intensive use of more affected arm in structured setting
15803051|NCT04425967|Radiation|pre-operative radiotherapy|pre-operative radiotherapy
15803052|NCT04425954|Procedure|Endoscopic Endonasal Pituitary Surgery|Surgical treatment consisted of an endoscopic endonasal approach using a rigid 0-degree endoscope, 18 cm in length and 4 mm in diameter.
15803053|NCT04425941|Other|artificial intelligence diagnosis|artificial intelligence prediction of colorectal polyp histology
15803054|NCT04425928|Procedure|occupational therapy based activity training programs|Occupational therapy based activity training programs in which exercises based on physiotherapy are put into the purposeful activities at vestibular rehabilitation.
15803055|NCT04425928|Procedure|Physiotherapy based exercise training programs|Cawthorne-cooksey exercises were performed at vestibular rehabilitation
15803056|NCT04425915|Biological|Convalescent Plasma|Dose-250 ml Frequency - 2 doses on consecutive days Duration -Start by day 3 of symptom onset (of severe COVID-19 as in inclusion criteria) in eligible patients
15803057|NCT04425915|Other|Standard of Care|The Ministry of Health and Family Welfare has issued detailed guidelines for the management of sCOVID-19 based on varying grades of severity which may be periodically updated. For the management of ARDS or sepsis the respective guidelines issued by ARDSNet and Surviving Sepsis campaign will be followed. Other institutional protocols for supportive management will be implemented. (Ref: Guidelines on Clinical Management of COVID-19. MoHFW, GoI.2020.)
15803058|NCT04425902|Drug|GSK3640254 200 mg|GSK3640254 will be available as oral tablets at unit dose strength of 100 mg.
15803059|NCT04425902|Drug|Caffeine 200 mg|Caffeine will be available as oral tablets at unit dose strength of 200 mg.
15803060|NCT04425902|Drug|Metoprolol 100 mg|Metoprolol will be available as oral tablets at unit dose strength of 100 mg.
15803061|NCT04425902|Drug|Montelukast 10 mg|Montelukast will be available as oral tablets at unit dose strength of 10 mg.
15803062|NCT04425902|Drug|Flurbiprofen 100 mg|Flurbiprofen will be available as oral tablets at unit dose strength of 100 mg.
15803063|NCT04425902|Drug|Omeprazole 40 mg|Omeprazole will be available as oral capsules at unit dose strength of 40 mg.
15803064|NCT04425902|Drug|Midazolam 5 mg (2.5 mL)|Midazolam will be available as syrup for oral administration at unit dose strength of 2 milligram per milliliter (mg/mL).
15803065|NCT04425902|Drug|Digoxin 0.25 mg|Digoxin will be available as oral tablet at unit dose strength of 0.25 mg.
15803066|NCT04425902|Drug|Pravastatin 40 mg|Pravastatin will be available as oral tablet at unit dose strength of 40 mg.
15803067|NCT04425889|Diagnostic Test|COVID-19 IgG/IgM Rapid Test Cassette test (Healgen Scientific, Houston, Texas, USA)|a blood sample is drained for detection of IgG and IgM antibody
15803148|NCT04425252|Drug|Brequinar|DHODH inhibitor, 100 mg daily x 5 days
15803069|NCT04425863|Drug|Ivermectin 5 MG/ML oral solution, Aspirin 250 mg tablets|24 mg oral Ivermectin on days 0 and 7 and 1 Aspirin tablet daily for 30 days. Outpatient treatment.
15803070|NCT04425863|Other|Ivermectin 5 mg/mL oral solution, Dexamethasone 4-mg injection, Aspirin 250 mg tablets|36 mg oral Ivermectin on days 0 and 7; 1 daily injection of 4-mg Dexamethasone until discharge, 1 Aspirin tablet daily for 30 days. Inpatient treatment in ward care, including Low flow washed oxygen or oxygen concentrator
15803071|NCT04425863|Other|Ivermectin 5 MG/ML oral solution, Dexamethasone 4-mg injection, Enoxaparin injection. Inpatient treatment with mechanical ventilation in ICU.|48 mg oral Ivermectin on days 0 and 7; 1 daily injection of 4-mg Dexamethasone until discharge, Enoxaparin 100 IU/kg (ca. 1 mg/kg) daily until transfer to ward care. Then continue with inpatient treatment in ward care.
15803072|NCT04425850|Combination Product|Iota carrageenan nasal spray and Ivermectin oral drops (used as buccal drops)|Topical application in the nose and oral cavity
15803073|NCT04425837|Biological|SARS-CoV-2 convalescent plasma treatment|Plasma transfusion of convalescent patients from COVID-19 with negative RT-PCR, and antibody titers of 1:160 or greater at a dose of 400ml distributed in two doses administered on the same day intravenous administration
15803074|NCT04425837|Other|Standard care|Standard care according to guidelines and national regulations
15803075|NCT04425824|Drug|Toripalimab combine with Rituximab|"Toripalimab is a recombinant, humanized programmed death receptor-1 (PD-1) monoclonal antibody that binds to PD-1 and prevents binding of PD-1 with programmed death ligands 1 (PD-L1) and 2 (PD-L2).
~Drug: Rituximab Rituximab is an antibody to CD20 molecules. One of the mechanisms of killing tumor cells is through antibody-dependent cell-mediated cytotoxicity (ADCC)."
15803076|NCT04425811|Other|kinesiological taping|The kinesiological banding applied to the tibialis anterior muscle was applied to improve walking parameters and compared to sham control.
15803077|NCT04425785|Other|Physical Exercise Program|A structured exercise program
15803078|NCT04425785|Behavioral|Cognitive Behavioural Therapy|A structured cognitive behavioural therapy program
15803079|NCT04425772|Drug|FNC+Standard of Care|FNC + Standard of Care according to the to the latest version of the National Health and Medical Commission Diagnostic criteria
15803080|NCT04425772|Drug|FNC dummy tablet+Standard of Care|FNC dummy tablet+ Standard of Care according to the to the latest version of the National Health and Medical Commission Diagnostic criteria
15803081|NCT04425759|Diagnostic Test|Blood sample|Blood sammples for the serological analysis will be collected at 0/90/180/270/360 days.
15803082|NCT04425746|Drug|Afamelanotide|
15803083|NCT04425746|Drug|Placebo|
15803084|NCT04425733|Drug|MK-5475|MK-5475 administered at a dose of 180 µg or ≤360 µg QD via inhalation
15803085|NCT04425733|Drug|Placebo|MK-5475-matching placebo administered QD via inhalation
15803088|NCT04425707|Drug|Ivermectin|use of Ivermectin in the treatment of COVID 19 patients, in comparison to and in addition to the standard care of treatment of COVID 19 in Egypt
15803089|NCT04425694|Device|e-EWS system|The e-EWS system is connected to a physiological monitor, which takes various physiological measurements. The system has an auto-charting module, which automatically captures patients' physiological measurements in an electronic chart (e-chart) and calculates their EWS. All the information in the auto-charting module is then wirelessly transferred to a central display in the ward's nurses station. The central display shows patients' status in terms of EWS and issues alerts when any EWS has exceeded a set threshold. The e-EWS system is not only capable of auto-charting but also provides an alert mechanism to help nurses detect early deterioration.
15803090|NCT04425681|Drug|Osimertinib|Treatment of LM With osimertinb
15803091|NCT04425681|Drug|Bevacizumab|Treatment of LM With Bevacizumab
15803092|NCT04425668|Behavioral|Academic detailing (AD)|In addition to continuing educational (CE) videos this group will receive up to two personalized, one-on-one, education sessions from an academic detailer. The sessions will last between 15-30 minutes. Each AD visit will consist of: an introduction, a brief needs assessment, key educational messages, a discussion of challenges the provider faces, and giving the provider leave-behind educational materials. The AD visit key educational messages are specific recommendations for opioid-prescribing practice change. When appropriate the detailer will suggest a phone call with Dr. Romesh Nalliah to discuss specific dentistry questions. There may also be a second AD visit if agreed upon by the dentist.
15803093|NCT04425668|Other|Continuing educational|"Dentists enrolled in the CE program will serve as the control group. They will have access to the 3 hours of CE content online similar to the AD group; however, they will not receive academic detailing or the opportunity to connect via phone with Dr. Nalliah.
~In this group, if the dentists have content-specific questions after participating in the CE program, they may contact MichiganOPENdental@umich.edu for responses appropriately directed to Dr. Nalliah."
15803094|NCT04425655|Drug|Fludarabine|30mg/m2 days 1 through 5
15803095|NCT04425655|Drug|Vyxeos|100U/m2 days 1, 3 5 in induction, 65U/m2 days 1 and 3 for consolidation
15803096|NCT04425642|Drug|Glucose/Amino acids|If indications for parenteral nutrition appear, it's dose will be calculated according patient's age and weight and will consist of glucose and amino acids solutions. To prevent potential complications of parenteral nutrition, the target dose will be reached by the third day of therapy. It will discontinued, when the patient oral food intake will be more than 60% for three consecutive days.
15803097|NCT04425642|Drug|Glucose/Amino acids/Lipids|If indications for parenteral nutrition appear, it's dose will be calculated according patient's age and weight and will consist of glucose, amino acids and lipid emulsions. To prevent potential complications of parenteral nutrition, the target dose will be reached by the third day of therapy. It will discontinued, when the patient oral food intake will be more than 60% for three consecutive days.
15803098|NCT04425629|Drug|casirivimab+imdevimab combination therapy|Administered intravenously (IV) single dose
15803149|NCT04425252|Other|Standard of Care|Standard of Care per institutional guidelines for COVID-19 patients
15803150|NCT04425239|Drug|Panitumumab|Continuous administation
15803151|NCT04425239|Drug|Panitumumab|Intermittent administation
15803099|NCT04425616|Other|Exercise|"At least one and up to three supervised sessions per week including:
~aerobic exercise at a rating of perceived exertion of 11-14 (6-20 scale) accumulating 20 minutes per session
~resistance exercise of 8-10 exercises for 2x 8-15 repetitions performed in a controlled manner and covering the whole body
~Range of motion exercise performed through pain free range of motion covering the whole body to be maintained in good alignment for 10-30 seconds, with some movements held for a second set of 10-30 seconds if stiff"
15803100|NCT04425616|Behavioral|Psychological and Behaviour Change Support|Instructors will be trained in Healthy Conversation Skills (HCS), Making Every Contact Count (MECC) or equivalent. This will enable them to deliver brief participant centred empowering interventions informed by social cognitive theory. This skill set will be used to support participants in adopting and maintaining the prescribed exercise and diet programme as well as adopting and practicing strategies to self-manage psychological well-being. Participants will be given the option to be provided with a SMARTER goal setting sheet to assist with goal planning. Applicable standardised psychological support resources will be made available to the participants though the Macmillan resource repository that they can access online or in alternative format as necessary, for example relaxation and mindfulness exercises
15803101|NCT04425616|Other|Nutrition|Instructors will receive training in generic nutritional principles in line with recommendations from World Cancer Research Fund (WCRF) and British Dietetic Association, and will work with participant to review own diet and eating habits against WCRF recommendations to enable goal setting and identify links to existing resources reputable websites, outputs and on-line forums. These would include: principles of healthy eating ('eat well' advice), weight management, symptom management, prehab advice before treatment starts, rehab advice during and after treatment. The participant will be asked if they are eating and drinking well or have any concerns at the beginning of each exercise session. Further support will be provided to instructors to address participant concerns or requests for additional information.
15803102|NCT04425603|Device|Anthology Hip Replacement System|
15803103|NCT04425590|Drug|DLBS1033|DLBS 1033 490 mg tablet 3 times daily
15803104|NCT04425590|Drug|Aspirin|Aspirin 100 mg tablet once daily
15803105|NCT04425590|Drug|Statin|Atorvastatin 20 mg tablet once daily
15803106|NCT04425590|Drug|Vit B12|Vit B12 100 mg tablet three times daily
15803107|NCT04425577|Diagnostic Test|Transabdominal Ultrasound|Transabdominal Ultrasound
15803108|NCT04425564|Drug|metronomic XELOX|
15803109|NCT04425564|Drug|Classic XELOX|
15803110|NCT04425564|Other|Blood samples for pharmacological studies|
15803111|NCT04425551|Procedure|laser light|laser light destruction of telangiectatic vessels of lower eyelid margin via selective thermolysis
15803112|NCT04425538|Drug|Infliximab|Either infliximab or infliximab-abda will be used at the discretion of the investigator
15803113|NCT04425512|Diagnostic Test|Complete Blood Count|Complete Blood Count samples
15803114|NCT04425499|Other|Learning running subcuticular sutures on the Gamified Educational Network|Each arm will have 15 participants who will learn how to perform running subcuticular sutures through videos on GEN.
15803115|NCT04425473|Drug|Esketamine|Esketamine will be administrated intravenously when suturing incision, with total dose of 0.2mg/kg and continuous infusion for 40 minutes.
15803116|NCT04425473|Drug|Normal saline|Equivalent amount of normal saline will be administrated intravenously suturing incision.
15803117|NCT04425460|Drug|Favipiravir|Favipiravir combined with supportive care recommended in the current National/Local guidelines. Favipiravir dosage and method of administration: Day 1 1800 mg x2; Day 2 up to a maximum of 14 days 600 mg x 3
15803118|NCT04425460|Other|Placebo|Placebo combined with supportive care recommended in the current National/Local guidelines. Placebo dosage and method of administration: Day 1 1800 mg x2; Day 2 up to a maximum of 14 days 600 mg x 3
15803119|NCT04425447|Drug|Tumescent local anesthesia|"Surgical disinfection of the area will be performed, skin inﬁltration with 2 mL of 1% lidocaine will be done, and wetting fluid will be used (1000 ml normal saline, 20 ml lidocaine 2%, and 1 mg epinephrine).
~Infiltration will be initiated with a 25-gauge needle. The 25-gauge needles cause little discomfort and provide enough local anesthesia to allow painless, more complete infiltration using a 20-gauge spinal needle. After the glandular nipple tissue is made somewhat tumescent, a larger (20-gauge) spinal needle can be more easily passed through the otherwise dense and resistant tissue."
15803120|NCT04425447|Drug|Thoracic paravertebral block|The paravertebral block (PVB) will be performed in the sitting position. Surgical disinfection of the thoracic paravertebral area will be done. A linear high-frequency transducer will be used. The scanning process (longitudinal out-of-plane technique) will be started at 5 to 10 cm lateral to the spinous process to identify the rounded ribs and parietal pleura underneath. The transducer is then moved progressively more medially until transverse processes are identiﬁed as more squared structure and deeper to the ribs. Once the transverse processes will be identiﬁed, skin inﬁltration with 2 mL of 1% lidocaine will be done. A 100-mm, 22 G needle will be inserted out of the plane to contact the transverse process and then walk off the transverse process 1 to 1.5 cm deeper searching for loss of resistance to inject 20 mL (5mL lidocaine 2% and 15 mL bupivacaine 0.25%) at each level of T4.
15803121|NCT04425447|Drug|Thoracic interfascial plane block|"Total LA injected was 80 mL (10 mL lidocaine 2% and 70 mL bupivacaine 0.25%) The linear probe will be placed below the outer third of the clavicle to detect anatomical landmarks, such as the serratus anterior muscle (SAM), external intercostal muscle (EIM), pectoralis muscles, thoracoacromial artery, and second rib. A test bolus of 1-2 ml of LA will be injected; upon confirmation of diffusion of the test dose between the external intercostal muscles and the SAM, a total of 20 ml of LA will be injected. The needle will be then carefully moved in the direction of the third and fourth ribs while confirming the expansion of the fascial plane.
~In the performance of the pecto-intercostal fascial plane block (PIFB), a probe will be placed parallel to the long axis of the sternum at a distance greater than 2 cm from the attachment of the second rib and sternum to identify the pectoralis muscles, EIM, and second rib. A"
15803152|NCT04425226|Drug|Pembrolizumab Injection [Keytruda]|Pembrolizumab (Keytruda, MSD China) is a recombinant anti-human PD-1 monoclonal antibody.
15803335|NCT04423744|Drug|Moxifloxacin|Film-coated tablet
15803124|NCT04425408|Device|Consecutive trial of two different devices for the treatment of positional sleep apnoea, for 3 nights with each device (positional pillow and vibrating belt).|Patients will be randomly allocated to use either a positional pillow or a vibrating belt for three consecutive nights at home followed by three nights with the other device.
15803125|NCT04425395|Behavioral|Cold pressor task (CPT)|"The cold pressor test is among the most common and established methods for studying human reactions to pain and pain tolerance. Participants submerge a hand in cold water (approx. 5°C) and are asked to keep their hand submerged for as long as can (until the sensation is intolerable), up to a maximum of 5 min. The procedure is safe because the hand is removed before adverse effects can occur. The participant will be given a break of 5 min in between trials, and will interchange hands between trials. During this break hand may to be place in warm water (25-35°C) for up to 4 min to normalise hand temperature, which will be measured before and after each trial using a digital thermometer held firmly in the palm of the hand.
~Each participant will complete no more than three trials (conditions) in a randomised order."
15803126|NCT04425395|Behavioral|Acoustic Recordings|During the experiment, the vocalizations produced will be systematically recorded for each participant and an analysis of the acoustic structure of these vocalizations will be carried out.
15803127|NCT04425395|Diagnostic Test|Index measurement NOL™|Four sensors placed non-invasively on one finger. of the participants will be able to calculate a dozen physiological parameters converts in real time into a pain index called NOL (for Nociception Level Index).
15803128|NCT04425395|Diagnostic Test|Video pupillometry|This technique is based on the observation of the dilatation of the pupil during the perception of a nociceptive stimulus in test persons.
15803129|NCT04425382|Drug|Darunavir/Cobicistat|Darunavir/Cobicistat (800mg/150mg) 1 tablet PO once daily
15803130|NCT04425382|Drug|Lopinavir/Ritonavir|Lopinavir/Ritonavir (200mg/50mg) 2 tablets PO twice daily
15803131|NCT04425369|Procedure|two-sided approaches for iliac crest bone graft|Only one side of the ilium was exposed when surgery.
15803132|NCT04425356|Behavioral|LifeXT Program|The intervention involves participation in and completion of the 4-month LIFEXT program, including: A baseline 15-20 minute health assessment administered online, a 50 minute introductory, one-on-one telephonic coaching session, four 50 minute one-on-one telephonic coaching sessions, optional coaching session follow-up activities (such as videos, practice exercises, and reading materials), and a post-intervention 15-20 minute health assessment administered online.
15803133|NCT04425343|Genetic|16s RNA Metagenomics sequencing|The subgingival plaque was collected using a sterile curette from the buccal aspect of maxillary molars and lingual aspect of mandibular incisors, in a vial containing 200µl of Buffer CL.
15803134|NCT04425330|Other|physiotherapy exercises|The evidence on the effectiveness of physical therapy in children with myelomeningocele is limited. The International Classification of Functionality, Disability and Health for Children and Youth is a useful tool to assist therapists in analyzing problems about the focus of the intervention. The evidence in physical therapy practice for individuals of all ages with neurological disorders, focuses on 5 Ps: prevention, prediction, participation, personalized and plasticity. Thus, neurological physiotherapists must perform the care with a focus on preventing the patient's disabilities, predicting the ideal response of an intervention, through measures of results of the movement system. In addition, it is of paramount importance that the goal of rehabilitation is that people with neurological disabilities are fully included and participate in life activities that are important to them and that their care is personalized. All of these measures facilitate the process of positive plasticity.
15803135|NCT04425330|Other|PBM|Photobiomodulation occurs from the application of low intensity light such as low intensity laser and light emitting diode (LED). The therapeutic effectiveness of phototherapy is based on the absorption of photons by photoreceptors or chromophores. Studies on the experimental model of spinal cord injury have shown that both wavelengths have the potential to be an effective and non-invasive means of therapy, promoting axonal appearance, increased concentration of glial cells and nerve connections, in addition to functional and sensitive. The findings of a clinical trial involving individuals diagnosed with spinal cord injury demonstrate that PBM exerted positive effects on motor function, especially during isotonic contraction of stimulated muscles assessed by electromyography, and there was a recovery in sensory perception and muscle strength.
15803136|NCT04425330|Other|SHAM PBM|SHAM PBM
15803137|NCT04425317|Diagnostic Test|Blood sample|Blood sample and endometrial biopsy on the moment of oocyte retrieval
15803138|NCT04425304|Behavioral|Group counseling|4 times
15803139|NCT04425304|Behavioral|Intensive group counseling|14 times
15803140|NCT04425304|Behavioral|Persuasive ICT support|Weekly reminders for 12 months
15803141|NCT04425291|Biological|4-valent HPV Vaccine|Subjects received 3 doses of 4-valent HPV vaccine according to a 0, 2, 6-month schedule.
15803142|NCT04425291|Biological|9-valent HPV Vaccine|Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.
15803143|NCT04425291|Biological|GARDASIL®|Subjects received 3 doses of GARDASIL® according to a 0, 2, 6-month schedule.
15803144|NCT04425278|Device|transcranial direct current stimulation with real current|transcranial direct current stimulation with real current is a noninvasive technique to activate and modify the activity of the neurons
15803145|NCT04425278|Device|transcranial direct current stimulation with sham current|transcranial direct current stimulation with sham current is a placebo
15803146|NCT04425265|Procedure|Plasma radiofrequency ablation|Under the guidance of nasal endoscope, the nasopharyngeal tumor and its sufficient safety margin are completely removed through the bilateral nasal cavity. Then investigators use plasma radiofrequency ablation at low temperature to ablate the tumor tissue and normal tissue of the margin along the upper and lower surgical margin until no obvious tumor remained under the naked eye.
15803147|NCT04425265|Procedure|Electrocautery block resection|Under the guidance of nasal endoscope, the nasopharyngeal tumor and its sufficient safety margin are continuously and completely removed through the bilateral nasal cavity. Then investigators separate the posterior part of the nasal cavity and the top wall of the nasopharynx along the bone of the nasopharyngeal fornix, cut the pharyngeal suture, and cut the two sides along the edge of the carina, and then merge along the anterior vertebral muscle surface to the midline incision. Along the the soft palate under the inferior margin, investigators horizontally cut the mucosa of the posterior wall of the nasopharynx, and completely frees the entire soft tissue of the posterior wall of the nasopharynx.
15803153|NCT04425226|Drug|Lenvatinib Oral Product|Lenvatinib (Lenvima, Eisai China) is a novel angiogenesis inhibitor which targets vascular endothelial growth factor 1-3, fibroblast growth factor receptor 1-4, platelet-derived growth factor receptor β, RET and KIT
15803154|NCT04425187|Drug|Gefitinib|gefitinib 250mg (1 tablet), once a day，PO
15803155|NCT04425187|Drug|Bevacizumab Combined With Gefitinib|Bevacizumab Combined With Gefitinib
15803156|NCT04425174|Procedure|Quadratous lumborum block|Quadratus Lumborum (QL) block is a new technique for analgesia of the abdominal wall muscles. Its mechanism depends on the injection of the local anesthetic agent between the abdominal wall muscles into the thoracolumbar fascia surrounding the Quadratus Lumborum muscle by ultrasound (US) guided technique.
15803157|NCT04425174|Procedure|Epidural anesthesia|Epidural analgesia is a gold standard analgesic technique for the majority of abdominal surgeries, yet it has some limitations in some surgeries as colorectal surgeries due to delayed ambulation due to muscular weakness and postural hypotension.
15803158|NCT04425161|Other|Fluid challenge (0.9 % NaCl)|500 ml Fluid challenge of (0.9 % NaCl) will be given
15803159|NCT04425148|Device|Transcranial Alternating Current Stimulation (tACS)|tACS is a noninvasive way of stimulating the brain externally using weak electric currents. Electrodes are placed into a cap that you wear on your head. A weak electrical current travels back and forth through the electrodes to your head.
15803160|NCT04425148|Device|Sham Transcranial Alternating Current Stimulation (sham tACS)|Sham (placebo) simulation of transcranial alternating current stimulation without receiving any real stimulation.
15803161|NCT04425135|Drug|Camrelizumab|200mg,D1,ivgtt, Q3w.
15803162|NCT04425135|Drug|Apatinib|250mg,Qd,Q3W.
15803163|NCT04425135|Drug|Pemetrixed|500 mg/m2,D1,ivgtt, Q3w.
15803164|NCT04425135|Drug|Carboplatin|AUC=5~6,D1,ivgtt, Q3w.
15803165|NCT04425122|Diagnostic Test|Upper endoscopy|Upper endoscopy would be performed. Biopsy would be taken from oesophageal cancer tissue and adjacent non-cancerous mucosa
15803166|NCT04425122|Diagnostic Test|Upper endoscopy|Upper endoscopy would be performed. Random biopsy would be taken from normal non-cancer esophageal mucosa.
15803167|NCT04425109|Behavioral|meal test response|soy fermented versus non fermented meal test
15803168|NCT04425096|Other|Skin to skin contact|Skin to skin contact
15803169|NCT04425083|Other|no intervention|no intervention
15803170|NCT04425070|Combination Product|ICE [ifosfamide+carboplatin+etoposide]|"• Combined with ICE chemotherapy regimen:
~Ifosfamide: 5 g/m2, continuous intravenous (iv) infusion (mesna 5 g/m2 synchronously iv infusion for rescue), on Day 2;
~Carboplatin: with concentration-area under time curve (AUC)=5 (highest concentration to 800 mg), iv infusion, on Day 2;
~Etoposide l00 mg/m2, iv infusion, on Days 1-3;
~ATG-010 60 mg/once, oral, on Days 4 and 11. After the treatment with combination chemotherapy, the patients will continue to receive maintenance treatment of ATG-010 60 mg/once per week (QW)."
15803171|NCT04425070|Combination Product|GEMOX [gemcitabine+oxaliplatin]|"• Combined with GEMOX chemotherapy regimen:
~Gemcitabine 1000 mg/m2, iv infusion, on Days 1 and 8;
~Oxaliplatin 130 mg/m2, iv infusion, on Day 1;
~ATG-010 60 mg/once, oral, on Days 2 and 9. After the treatment with combination chemotherapy, the patients will continue to receive maintenance treatment of ATG-010 60 mg/once per week (QW)."
15803172|NCT04425057|Other|Interval training|
15803173|NCT04425044|Other|Other|No Intervention
15803174|NCT04425031|Drug|Oxygen|Oxygen administration to achieve a PaO2 of 8 kPa (60 mmHg) from ICU admission to ICU discharge
15803175|NCT04425031|Drug|Oxygen|Oxygen administration to achieve a PaO2 of 12 kPa (90 mmHg) from ICU admission to ICU discharge
15803176|NCT04425018|Drug|Paclitaxel|Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks.
15803177|NCT04425018|Drug|Pertuzumab|Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
15803178|NCT04425018|Drug|Margetuximab|Pre-determined dose administered by IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks.
15803179|NCT04425018|Drug|Trastuzumab|Pre-determined dose administered via IV Day 1 of each 21- day cycle for 4 study cycles, or 12 weeks.
15803180|NCT04425005|Other|Home-based exercise|Home-based exercise training, supervised by videoconference.
15803181|NCT04424992|Other|Observational cohort study on the natural history of hospitalized SARS-COV-2 patients.|Describe the natural history and clinical evolution of hospitalized patients over time affected by SARS-COV-2 infection, understand the pathogenesis of the disease and improve the aids and therapeutic procedures.
15803182|NCT04424979|Device|High power prisms|High power prisms designed to shift images from blind areas into portions of the wearer's remaining, seeing, field of vision
15803183|NCT04424966|Drug|Infigratinib|The Phase 0 study will include treatment of recurrent high-grade glioma participants with 125 mg of infigratinib 7 days prior to surgical resection. Participants with tumors demonstrating PK-response will continue treatment with the same dose continuously for 21 days in 28-day cycles after surgery.
15803184|NCT04424953|Device|McGrath videolaryngoscope|A brand of a commonly-used videolaryngoscope which has a camera at the end of the laryngoscope to visualize the vocal cords
15803185|NCT04424953|Device|Direct laryngoscope|Classic direct laryngoscope that depends on visualization of the vocal cords by the operator
15803186|NCT04424927|Biological|PRV-015|Fully human monoclonal antibody against interleukin 15 (IL-15)
15803187|NCT04424927|Other|Placebo|Placebo
15803189|NCT04424901|Drug|Dipyridamole|Dipyridamole-100mg taken 3 times a day by mouth for 7 days.
15803190|NCT04424888|Other|WB-011|WB-011 medical food product.
15803191|NCT04424888|Other|Placebo|Placebo Capsules identical to those containing WB-011.
15803192|NCT04424888|Device|Continuous Glucose Monitor|Abbott Freestyle Libre(™) Glucose Sensors were used throughout the study.
15803193|NCT04424875|Drug|3 mg melatonin|patients will remove impacted third molar and receive 3 mg melatonin into 2 ml hydroxyethyl cellulose gel 2%
15803194|NCT04424875|Drug|Placebo|patients will remove impacted third molar and receive 2 ml hydroxyethyl cellulose gel 2%
15803195|NCT04424862|Drug|Prednisone, ciclosporin and mycophenolate mofetil|Multitarget Therapy
15803266|NCT04424251|Drug|HSK21542|Once preoperative and once each at 0 and 12 h postoperative, for a total of 3 administrations (adjusted according to the results of the first 3 groups)
15803336|NCT04423744|Drug|Placebo|Matched placebo as film-coated tablet
15803196|NCT04424862|Drug|Ponticelli Regimen|Month 1: i.v. methylprednisolone (0.5 g) daily for three doses, then oral prednison (0.5 mg/kg/d, maximum dose 30mg/d) for 27 days Month 2: Oral cyclophosphamide (2.0 mg/kg/d, maximum dose 100mg/d) for 30 days Month 3: Repeat Month 1 Month 4: Repeat Month 2 Month 5: Repeat Month 1 Month 6: Repeat Month 2
15803197|NCT04424849|Diagnostic Test|CT-Scan|Chest CT scan on admission to the intensive care unit
15803198|NCT04424836|Device|high flow nasal cannula device|device is supplying oxygen with heated and humidified air in a high flow rate
15803199|NCT04424823|Procedure|LED photobiomodulation|Patients were submitted to photobiomodulation therapy with wavelengths of both 630-nm and 850-nm for RED and near-infrared LEDs, with power density set to 8.5 mW/cm2 and 12.5 mW/cm2, respectively. The LED device (name of device, Applied BioPhotonics) was designed in Silicon Valley, United States, and was approved by the United States Food and Drug Administration for the treatment of minor muscle and joint pain. LED therapy was applied by placing the device on the skin at a 90° angle. Both groups underwent six times therapy sessions (i.e., three times a week for 2 weeks), and during the therapy, only the researcher in charge of programming the LED device was aware of the treatment employed; the programmer did not participate in the execution of the treatments, evaluations, or data analysis.
15803200|NCT04424810|Other|High-quality, physician created video|The intervention group will watch a short (2-5 minute) video prior to surgery that will provide them with information about their condition and the procedure they are about to undergo (either carpal tunnel release or trigger finger release).
15803201|NCT04424810|Other|Standard of care|Patients in the control group will not be asked to do anything differently prior to their surgery
15803202|NCT04424797|Other|Prone Positioning|Intervention is patient in prone positioning
15803203|NCT04424797|Other|Supine Positioning|Intervention is patient in supine positioning
15803204|NCT04424784|Biological|5% O2|5% oxygen will be used during oocyte retrieval, fertilization check and embryo grading
15803205|NCT04424771|Behavioral|Maslach Burnout Inventory (MBI)|The Maslach Burnout Inventory is an introspective psychological inventory consisting of 22 items pertaining to occupational burnout.
15803206|NCT04424758|Other|Video information about mammography screening|A video informing about mammography screening
15803207|NCT04424758|Other|Video information about smart energy systems|A video informing about smart energy systems
15803208|NCT04424745|Other|Simultaneous Attention Bias Modification Training and Transcranial Direct Current Stimulation (tDCS)|Participants will receive 10 sessions of computerised attention bias modification training with either real or sham tDCS. Participants will self-administer tDCS at home, with research supervision, and complete attention bias modification training on a laptop or desktop computer while receiving stimulation. Sessions will be completed week daily for 2-3 weeks.
15803209|NCT04424732|Radiation|Stereotactic Body Radiotherapy|This is a prospective study of breast bone only oligometastases (up to three sites). Following systemic treatment and primary tumor control, patients will receive SBRT to all metastatic sites. Data on toxicities and oncological outcomes will be collected for future analysis. There will be no change in the standard systemic therapy nor the local therapy of the primary tumor.
15803210|NCT04424719|Other|Blood test|"High risk patients are referred for the medical oncology consultation to organize oncological surveillance after general staging of the disease. Signature of the informed consent of SALOME study, inclusion in the study and risk-adjusted surveillance schedule :
~(i) Liver MRI every 6 months performed at the expert center for UM (according to guidelines).
~(ii) For enucleated patients, a blood sample (3 x 6 ml EDTA tubes) is taken every 6 months according to the schedule below. Plasma and mononucleated cells will be isolated and preserved for bio-markers research.
~M0 : during the first medical oncology visit.
~At each imaging assessment, every 6 months for at least 5 years (M6 to M60) and 10 years maximum (M120).
~At the diagnosis of metastasis.
~At each significant event during the metastatic disease (surgery, treatment response or progression)."
15803211|NCT04424706|Diagnostic Test|diagnosed as type 2 diabetes without atherosclerosis|patients diagnosed as type 2 diabetes without atherosclerosis
15803212|NCT04424706|Diagnostic Test|diagnosed as type 2 diabetes with atherosclerosis|patients diagnosed as type 2 diabetes with atherosclerosis
15803213|NCT04424706|Diagnostic Test|people without type 2 diabetes or atherosclerosis|normal people without type 2 diabetes or atherosclerosis
15803214|NCT04424693|Drug|Tdap Vaccine Administration|Tdap vaccinations are routinely given during pregnancy between weeks 27 and 36 per guidelines of American College Obstetrics and Gynecology (ACOG) -- but this study uniquely is trying to establish that the earlier Tdap vaccinations reduce preeclampsia by more than 50%
15803215|NCT04424680|Behavioral|Advanced Care Planning program of health decisions|Application of an Advanced Care Planning program program for decision-making in patients with advanced Heart Failure, in comparison to usual follow up and care.
15803216|NCT04424667|Other|donor milk|pasteurized donor milk
15803217|NCT04424654|Drug|Testosterone cypionate|Testosterone cypionate 400 mg IM
15803219|NCT04424628|Radiation|Low dose radiotherapy A|Low dose radiotherapy was 0.5 Gy in 6 fractions. Evaluation of pain and Quality of Life in 8-12 weeks. If no pain releave the patient is randomized to 3 or 6 Gy again
15803220|NCT04424628|Radiation|Low dose radiotherapy B|Low dose radiotherapy was 0.5 Gy in 6 fractions. Evaluation of pain and Quality of Life in 8-12 weeks. If no pain releave the patient is treated with 6 Gy again
15803221|NCT04424602|Drug|cyclo phosphamide|500mg vial
15803222|NCT04424602|Drug|mycophenolate|500mg film-coated tablets.
15803223|NCT04424589|Other|Myofascial release|Myofascial release or induction (IMF) is a widely used manual therapy treatment involving specifically guided, low-load, long-lasting mechanical forces to manipulate the myofascial complex, aimed at restoring optimal length, decreasing pain, and improving function. The experimental group will receive 1 examination session and 6 myofascial induction sessions carried out by a physiotherapist specialized in orthopedic manual therapy, superficial and deep techniques will be applied in the cervical region, for spinal at the level of the lumbar square, sacroiliac region and upper trapezius. 2 sessions per week over the course of 3 weeks.
15803267|NCT04424251|Drug|Placebo 0.4 μg/kg|Once preoperative and once each at 0, 8, and 16 h postoperative, for a total of 4 administrations
15803224|NCT04424589|Other|Sham therapy|The control group will receive 1 examination session and 6 simulated myofascial induction sessions, where a physiotherapist will apparently apply the same techniques and maneuvers of myofascial induction, however, they will not follow the basic principles of technique execution, which does a procedure with a placebo effect.
15803225|NCT04424563|Device|ventilators|all patients in both groups will be ventilated if shocked and no recordable blood pressure
15803226|NCT04424563|Drug|aminocaproic acid|4 gram slowly intravenous infusion over 1 hour and continues slowly intravenous infusion 1 gram/ hour for 8 hours.
15803227|NCT04424563|Drug|Novo Seven|200 microgram/kg. If patient still oozing, vital data not stable and/or could not achieve and keep the target Hb (>10 gm%) another 2 doses of aFVII received
15803228|NCT04424537|Dietary Supplement|Control diet|Meal replacement beverages made with whey protein
15803229|NCT04424537|Dietary Supplement|Low branched-chain amino acids(BCAA) diet|meal replacement beverages (MRBs) made with BCAD2 powder (lacking BCAAs).
15803230|NCT04424537|Dietary Supplement|Low protein diet|meal replacement beverages(MRBs) containing low protein
15803231|NCT04424511|Drug|Placebo|Placebo mixture will be administered as a single dose in oral suspension form for children 1-11 months of age. Weight-based dosing will be used: single-dose of 0.5 ml / kg child weight.
15803232|NCT04424511|Drug|Azithromycin|Azithromycin will be administered as a single dose in oral suspension form for children 1-11 months of age. Weight-based dosing will be used: single-dose of 0.5 ml (20 mg) / kg child weight.
15803233|NCT04424498|Procedure|Absorbable Rods and Kirschner Wires|A Boyd incision was applied in all patients; olecranon fractures were reduced first and fixed with Kirschner wires. Then, the displaced radial neck fractures were reduced and fixed using absorbable rods.
15803234|NCT04424485|Procedure|Total thyroidectomy (TT)|Standard TT procedure for thyroid carcinoma, for both groups
15803235|NCT04424485|Procedure|Central lymph node dissection (CLND)|Standard CLND for thyroid carcinoma, for both groups
15803236|NCT04424485|Diagnostic Test|Sentinel lymph node (SLN) bopsy|Intrathyroidal injection of ICG for SL biopsy, for only experimental group
15803237|NCT04424485|Diagnostic Test|Identification of parathyroid glands (PGs)|Near-infrared (NIR) fluorescence visualization of PGs, for only experimental group
15803238|NCT04424472|Diagnostic Test|Ultrasonography|Abdominal Ultrasonography
15803239|NCT04424459|Drug|opioid withdrawal|The data retrieved from the patient will be encrypted and there will also be written data or written in binary form. They will be used to create an Excel table which allows me to list the data on D1 then on M + 3 then on M + 6 in order to evaluate the evolution of these data over a time interval of 6 months and this is which will be used as support in my thesis in pharmacy.
15803240|NCT04424433|Drug|Oxygen|Two FIO2 settings during stable general anaesthesia resulting in normoxaemic and hyperoxic arterial oxygen partial pressures.
15803241|NCT04424420|Drug|Paracetamol|Paracetamol oral tablet
15803242|NCT04424420|Drug|Ibuprofen|Ibuprofen oral tablet
15803243|NCT04424420|Drug|Placebo oral tablet|Sugar pill manufactured to mimic the Paracetamol and Ibuprofen.
15803244|NCT04424407|Behavioral|Cognitive Behavioral Therapy for Insomnia|Participants will meet with a psychologist once a week for six weeks to complete a brief CBT-I intervention. Cognitive Behavioral Therapy for Insomnia consists of a cognitive therapy and a behavioral therapy. The cognitive therapy is designed to identify incorrect ideas about sleep, challenge their validity, and replace them with correct information. This therapy tries to reduce worry, anxiety, and fear that one won't sleep by providing accurate information about sleep. The behavioral therapy increases sleep quality by limiting excessive time spent in bed to increase homeostatic sleep drive and sleep consolidation.
15803245|NCT04424394|Device|DualStim Therapy|6 DualStim Therapies over a period of 7 weeks.
15803246|NCT04424394|Biological|Umbilical cord-derived Wharton's Jelly|2 intracavernosal injections over a period of 7 weeks.
15803247|NCT04424394|Other|Saline|2 intracavernosal injections over a period of 7 weeks.
15803248|NCT04424381|Drug|Rivaroxaban 20 MG Oral Tablet [Xarelto]|The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet [Xarelto].
15803249|NCT04424381|Drug|Rivaroxaban 20 MG Oral Tablet|The subjects randomly received single oral administration of Rivaroxaban 20 MG Oral Tablet.
15803250|NCT04424368|Device|The remote monitoring system|Usage of remote monitoring system
15803251|NCT04424355|Diagnostic Test|Chest MRI|Patients referred by the primary care physician with suspected pneumonia
15803252|NCT04424342|Other|Pre-test procedure|The Turkish version of CPQ8-10 was subjected to a preliminary test on a group of 20 children, who were not included in the final study, in order to discuss the intelligibility of the items and to determine comprehension problems for children of this age group
15803253|NCT04424342|Other|Test re-test|The Turkish version of CPQ8-10 was administered to 50 children who were asked to complete the questionnaire on their own without any assistance. These 50 children were interviewed for a second time within two weeks to measure the reliability of the test-retest
15803254|NCT04424329|Dietary Supplement|Fibers and probiotics|A blend of fibers and seven probiotics
15803257|NCT04424303|Drug|Tofacitinib|Observational study
15803259|NCT04424277|Other|diaphragm ultrasound|respiratory loading
15803260|NCT04424264|Drug|Phase 1: Tenofovir disoproxil fumarate/Emtricitabine/Efavirenz coadministered with Rifampicin/Isoniazid|TDF/FTC/EFV 300/200/600 mg once daily plus RIF/INH 600*/300 mg daily from screening until enrolment (days -15 to 0)
15803261|NCT04424264|Drug|Phase 2: Tenofovir alafenamide/Lamivudine/Efavirenz coadministered with Rifampicin/Isoniazid|TAF 25 mg + 3TC 300 mg + EFV 600 mg once daily plus RIF/INH 600/*300 mg daily (days 1 to ≤ 56)
15803262|NCT04424264|Drug|Phase 3: Tenofovir disoproxil fumarate/Emtricitabine/Efavirenz|TDF/FTC/EFV 300/200/600 mg once daily. RIF/INH 600mg <70kg, 750mg >70kg
15803263|NCT04424251|Drug|HSK21542 0.4 μg/kg|Once preoperative and once each at 0, 8, and 16 h postoperative, for a total of 4 administrations
15803264|NCT04424251|Drug|HSK21542 1 μg/kg|Once preoperative and once each at 0, 8, and 16 h postoperative, for a total of 4 administrations
15803265|NCT04424251|Drug|HSK21542 2 μg/kg|Once preoperative and once each at 0, 8, and 16 h postoperative, for a total of 4 administrations
15803269|NCT04424251|Drug|Placebo 2 μg/kg|Once preoperative and once each at 0, 8, and 16 h postoperative, for a total of 4 administrations
15803270|NCT04424251|Drug|Placebo|Once preoperative and once each at 0 and 12 h postoperative, for a total of 3 administrations (adjusted according to the results of the first 3 groups)
15803271|NCT04424238|Behavioral|m-health management|Patients in intervention group received additional WeChat group management when conducted standard clinic prenatal care.
15803272|NCT04424225|Drug|Psilocybin|25 mg capsules (white opaque, Capsugel Vcaps Plus HPMC size 2)
15803273|NCT04424225|Drug|Niacin|100 mg capsules (white opaque, Capsugel Vcaps Plus HPMC size 2)
15803274|NCT04424212|Behavioral|Intervention group CoronaCope|Intervention based on cognitive behavioural therapy principles and adapted to the coronavirus pandemic situation. Intervention's main purpose is to mental health issues such as depressive symtoms, stress, worry and anxiety related to the coronavirus pandemic and increase quality of life in the current situation. Intervention contains psycho-educational elements as well as examples and exercises.
15803277|NCT04424186|Other|'Rehabilitation for Life'|An empowerment-oriented cross-sectorial program including vital sign measurement and systematic progressive rehabilitation combined with convenient access for collaboration among professionals.
15803278|NCT04424186|Other|Usual care and rehabilitation|The care and rehabilitation usual provided to patients after hip fracture surgery
15803279|NCT04424160|Biological|PRP injection in the endometrium|Within 5 days after the cessation of menstrual period, endometrial PRP procedure will be planned. Approximately 20 ml of blood sample will be collected under sterile conditions, and PRP will be prepared. The same day, within 2 hours of sample preparation, PRP injection will be performed transvaginally under ultrasound guidance and under sedation anesthesia into the endometrial region of the endometrium in several positions.On the same day after the procedure, the patient will be observed in the outpatient room and will be discharged on the same day.
15803280|NCT04424147|Combination Product|HVA Regimens as Salvage Treatment|venetoclax with a dose of 400mg per day for 14 days, combined with azacitidine (AZA) with a dose of 75mg/m2 per day for 7 days, and HHT 1mg/m2 per day for 7 days
15803281|NCT04424134|Drug|Bromhexine and Spironolactone|Bromhexine 8 mg x 4 times a day x 10 days Spironolactone 50 mg x once a day x 10 days
15803282|NCT04424134|Drug|Base therapy|Therapy currently recommended by Ministry of Health of Russian Federation for COVID 19 treatment
15803283|NCT04424121|Diagnostic Test|CCTA|Coronary Computed Tomography Angiography
15803284|NCT04424095|Diagnostic Test|In-office vascular visit|The patient will be examined to search for signs or symptoms of chronic venous disease (teleangiectasia, reticular veins, varicose veins, skin changes, pain, itching, heavy legs, ankle edema)
15803285|NCT04424095|Diagnostic Test|Echo Duplex of lower limbs|The venous system of lower limbs will be checked in order to detect any vein dilation and reflux.
15803286|NCT04424082|Other|Removal of dead space filter|Dead space filters will be removed and Vcap parameters (VCO2 ml/min, PaCO2 kPa, alveolar dead space in ml) recorded before and after removal
15803287|NCT04424069|Procedure|Refractive surgery|Myopic patients seeking refractive surgery will be assigned to the study groups to assess the change in myopic and papillary perfusion in these different prodecures
15803288|NCT04424056|Drug|Anakinra +/- Ruxolitinib (stages 2b/3)|administration of Anakinra +/- ruxolitinib, depending of evolution
15803289|NCT04424056|Drug|Anakinra and Ruxolitinib (Advanced stage 3)|administration of Anakinra and ruxolitinib
15803290|NCT04424056|Drug|Tocilizumab +/- ruxolitinib (stages 2b/3)|administration of Tocilizumab +/- ruxolitinib, depending of evolution
15803291|NCT04424056|Drug|Tocilizumab and Ruxolitinib (Advanced stage 3)|administration of Tocilizumab and Ruxolitinib
15803292|NCT04424056|Other|Standard of care|Treatment with drugs or procedures in routine clinical practice
15803293|NCT04424043|Procedure|neo-TACE-HAIC+Surgery|transartery chemoembolization with lipiodol and EADM, FOLFOX (Oxa 85mg/m2 2h+CF 400mg/m2 2h +5FU 400mg/m2 10min+5FU 1200mg/m2 23h)-based artery infusion chemotherapy, followed by hepatic resection
15803294|NCT04424043|Procedure|Surgery alone|hepatic resection remove the liver tumors
15803295|NCT04424030|Diagnostic Test|Echocardiography|Standard echocardiography exam performed as part of clinical management.
15803296|NCT04424030|Diagnostic Test|Magnetic resonance imaging (MRI)|Standard comprehensive cardiac MRI exam of the heart performed as part of clinical management.
15803297|NCT04424030|Diagnostic Test|Computed tomography (CT)|ECG-triggered, contrast-enhanced CT scan of the heart performed for research purposes in eligible study participants.
15803298|NCT04424017|Biological|Specific anti-SARS-CoV-2 antibodies|"A serum sample needs to be collected from each participant upon recruitment into the investigation All samples will be tested by the rapid test (Artron, Artron Laboratories, Burnaby, Canada), IgM / IgG which is an antibody capture Immunochromatografac assay for simultaneous detection of IgM and IgG in serum or plasma for COVID -19 in samples.
~All samples will be tested for total Immunoglobulins and IgG in samples for COVID-19 virus by Ortho clinical diagnostics chemiluminescent technique (Ortho, Raritan, USA)."
15803299|NCT04424004|Other|COVID-19 PCR and serology testing|"PCR testing: participate will conduct at-home collection and return of self-administered nasal swabs for COVID-19 polymerase chain reaction (PCR) viral testing. Saliva specimens may replace the nasal swab specimen. Specimens will be collected at baseline and every 2 weeks in conjunction with questionnaire administration.
~Serology testing: The same randomized participants will also provide a blood sample for serologic testing for SARS-CoV-2 IgG antibodies. Specimens will be collected by routine venipuncture at the MURDOCK Study office in Kannapolis, NC.Specimens for serology will be collected at baseline approximately 1 month after the first questionnaire and 2 weeks after the first nasal swab collection and COVID-19 PCR testing. Specimens for serology will be collected at least bi-monthly and up to monthly thereafter through a total study duration of 6, and up to 12, months."
15803300|NCT04423991|Device|COViage|Machine learning intervention
15803301|NCT04423965|Drug|mFOLFOXIRI|irinotecan 165 mg/m² IV day 1+ oxaliplatin 85 mg/m² IV day 1 + leucovorin 400 mg/m² day 1, fluorouracil 1200mg/m²/day *2 days (total 2400 mg/m² over 48 hours) continuous infusion starting on day 1 of each 2 weeks cycle
15803302|NCT04423965|Combination Product|Chemoradiotherapy|Capecitabine based chemoradiotherapy
15803303|NCT04423952|Other|COMQ-12 questionnaire|Subjects respond to COMQ-12 questionnaire twice at 15 days apart. COMQ-12 : quality of life measurement questionnaire related to chronic otitis media.
15803304|NCT04423939|Behavioral|Acceptance and Commitment Therapy (ACT)|The ACT sessions will be tailored to the clinical challenges of HCT. Sessions are with a mental health professional and are 45-60 minutes in duration and include both the participant and caregiver.
15803305|NCT04423926|Drug|Lenalidomide|Lenalidomide 10mg/d#15mg/d#20mg/d#25mg/d d1~d10# 21days a cycle
15803306|NCT04423926|Drug|Cyclophosphamide|Cyclophosphamide 750 mg/m2 d1
15803307|NCT04423926|Drug|Doxorubicin|Doxorubicin 50 mg/m2 d1
15803308|NCT04423926|Drug|Vincristine|Vincristine 1.4mg/m2 (maximum 2mg) d1
15803309|NCT04423926|Drug|Prednisolone|Prednisolone 60mg/m2 d1-5
15803310|NCT04423913|Other|Administration of embolization beads|Patients will receive embolization beads, loaded with doxorubicin or not.
15803311|NCT04423900|Diagnostic Test|smart phone application|Participants will be asked to provide information about their sociodemographic characteristics, chronic diseases, the history of the ankle injury, trauma, and surgery, the severity of the foot pain via using the mobile application.The app will be downloaded from the Google Play Store and available offline. Information from the patient will be stored in an SQLite database.The usability test will be carried out on the mobile application so that the latest releases contain clear, effective, loyal to the strategy, and easily understood messages by the intended audience and do not produce unwanted responses.Direct observation, individual interviews, and satisfaction surveys will be used to identify areas of improvement in a cross-sectional manner.Investigation of pes cavus, pes planus and ankle range of motion will be determined by image processing.All data can be analyzed and stored by Heel Analysis Systems established on an external server.The data will be transferred securely over HTTPS.
15803312|NCT04423887|Other|Lower Extremity Resistance Exercise Training|"Treadmill walking 5-10 min for warm up Strength training: (80% of 8RM)
~3 times supervised exercise for 4 weeks Warm up (Self Paced walking for 10 minutes) leg press, leg extension, Sit to stand squat (mini squats) Stationary Cycling (Maximum Resistance as per patient tolerance till failure)
~3 sets 8 reps 10-15 s rep rest interval 1-2 min set rest interval"
15803313|NCT04423887|Other|Home Exercise Plan|"2 sets of 10 repetitions/day of
~AROM isolated knee extension and knee flexion Isometric isolated knee extension and knee flexion Isometric terminal knee extension Sit to stand squat Isometric knee terminal extension"
15803314|NCT04423887|Device|Electrotherapy + Heating|Interferential Current therapy (2P), in combination with heating pad for 20 minutes
15803315|NCT04423887|Procedure|Joint Mobilization|Tibio-femoral Anterior Glide Tibio-femoral Posterior Glide Patellofemoral Joint Mobilization
15803316|NCT04423887|Dietary Supplement|Creatine Supplementation|Creatine Supplementation 20g/day for 1 week followed by 5 g/day for 3 weeks
15803317|NCT04423874|Behavioral|Cold pressor task (CPT)|"The cold pressor test is among the most common and established methods for studying human reactions to pain and pain tolerance.
~Participants submerge a hand in cold water (approx. 5°C) and are asked to keep their hand submerged for as long as can (until the sensation is intolerable), up to a maximum of 5 min.
~The procedure is safe because the hand is removed before adverse effects can occur.
~The participant will be given a break of 5 min in between trials, and will interchange hands between trials.
~During this break hand may to be place in warm water (25-35°C) for up to 4 min to normalise hand temperature, which will be measured before and after each trial using a digital thermometer held firmly in the palm of the hand. Each participant will complete no more than three trials (conditions) in a randomised order."
15803318|NCT04423874|Diagnostic Test|index NOL|Measurement of the index NOL™: Four sensors, placed non-invasively on one of the four participants' fingers, will make it possible to calculate a dozen physiological parameters converts in real time into a pain index called NOL (for Nociception Level Index).
15803319|NCT04423874|Behavioral|Playback Experiments|During the experience, participants are led to listen, via headphones, to aversive non-verbal vocalizations (baby crying). The sound levels used to broadcast the non-verbal vocalisations will be scrupulously measured using approved and certified equipment during the preparation of the experiments. These sound volumes will be chosen so as not to inconvenience participants.
15803320|NCT04423874|Diagnostic Test|Video-pupillometry|This technique is based on the observation of the dilatation of the pupil during the perception of a nociceptive stimulus in test persons.
15803321|NCT04423861|Drug|Nitazoxanide|Patients will receive nitazoxanide 600 mg BID for 7 days.
15803322|NCT04423861|Drug|Placebo|Patients will receive matching placebo BID for 7 days.
15803323|NCT04423848|Other|Home Hospital for Lymphoma|Remote monitoring and home-based care designed for hospitalized patients with lymphoma
15803324|NCT04423835|Procedure|Paley's Principle osteotomy|. The osteotomy line of all patients was designed according to Paley's principles. The lateral incision was applied in all patients and the osteotomy lines were marked on the humerus with the assistance of C-arm radiographs. An isosceles triangle template was used for osteotomy, and the medial cortex was left intact. K-wires were used to fix the osteotomy laterally.
15803325|NCT04423822|Other|stress test|endurance capacity
15803326|NCT04423809|Other|clinical assessment|assessment of caregivers suffering when a family member is hospitalized
15803329|NCT04423783|Behavioral|7-day exposure therapy via self-developed app according to (Haberkamp et al., submitted)|Confrontation with spiders via gamified app
15803330|NCT04423783|Behavioral|Therapist-guided one-session online exposure therapy according to (Öst, 1989)|Massed exposure therapy over the course of one single session, applied in a remote-online context
15803331|NCT04423770|Other|No intervention|No intervention; this is a purely observational study
15803332|NCT04423757|Drug|BI 1358894|BI 1358894
15803333|NCT04423757|Drug|Placebo|Placebo
15803334|NCT04423744|Drug|BAY1817080|Film-coated tablet
15803337|NCT04423731|Drug|Folfirinox|Neoadjuvant chemotherapy is given according to different regimens, preferably FOLFIRINOX according to the recommendations in the national Norwegian guidelines. The choice of chemotherapy regimen is decided by the treating oncologist.
15803340|NCT04423692|Other|labs|A group of questions to women regarding Corona with laboratory finding suggestive of covid 19 and coagulopathy
15803341|NCT04423679|Device|Evalyn Brush|a standard brush-based cervicovaginal self-collection device
15803342|NCT04423666|Behavioral|Walking using a wireless pedometer|See arm/group
15803343|NCT04423653|Behavioral|Telehealth home exercise program|The intervention will include videos of exercises and also live coaching using telehealth system.
15803344|NCT04423640|Other|Active COVID-19 disease|Adult patients admitted to the UMAE Specialty Hospital of CMN SXXI with a diagnosis of COVID-19. The diagnosis must be corroborated by the RT-PCR test.
15803345|NCT04423627|Drug|Clonidine|Clonidine 0.2 mg/day oral tablet
15803346|NCT04423627|Drug|Hydrochlorothiazide|Hydrochlorothiazide 37.5 mg/day oral tablet
15803347|NCT04423627|Drug|Placebo|Placebo
15803348|NCT04423614|Other|Inspiratory Muscle Training|Inspiratory muscle training exercises, performed 5 times a week for 2-4 weeks prior to cardiac surgery.
15803349|NCT04423614|Other|Relaxation Breathing|Relaxation breathing exercises, performed 5 times a week for 2-4 weeks prior to cardiac surgery.
15803352|NCT04423588|Diagnostic Test|dexlansoprazole serum concentration|6 blood samples are collected at fixed time Points after oral Administration of 1 dose of dexilant at regular patients visits preoperatively and 3 and 6 months post-surgery.
15803353|NCT04423588|Diagnostic Test|upper endoscopy|6 and 12 months after surgery the occurrence of marginal ulcers in the same Patient Group is examined by upper endoscopy. The 12-month endoscopy is part of the Routine postoperative diagnosis, the 6-month endoscopy is for study purpose.
15803354|NCT04423575|Other|Outpatient health care pathway|A surgical procedure performed as an outpatient procedure means that the patient leaves the hospital before 8pm the same day. The surgery is identical but the standard care pathway is reinforced to insure a safe return to home.
15803355|NCT04423562|Other|No intervention|No intervention
15803356|NCT04423510|Procedure|Crystallized phenol treatment|
15803357|NCT04423497|Other|Balance Evaluation Systems Test|Balance Evaluation Systems Test application
15803359|NCT04423471|Diagnostic Test|Sociodemographic variables|"Sociodemographic variables: Sex / Age / Marital status / Level of studies completed / Employment status.
~General clinical variables: Body mass index (BMI), Medical comorbidities and Charlson Comorbidity Index, Active drug treatments
~Clinical psoriasis variables: BSA, PASI, ScalpPASI, PPPASI, DLQI, time since the diagnosis of psoriasis, previous treatments for psoriasis.
~Clinical depression variables: Psychiatric diagnoses according to clinical interview and DSM-5 criteria, age of onset and time of evolution from the first episode of major depression, time of evolution of the current episode of major depression, previous treatments for depression.
~Psychopathological variables: HADS, PHQ-9, MADRS, GAD-7, SHAPS, The Irritability Questionnaire, PSS, FSS, MoCA.
~Immunological and biochemical variables: Acute phase biomarkers, Proinflammatory cytokines, Anti-inflammatory cytokines, HPA axis, Microglia activation, Neurogenesis.
~Result variables: Changes in PASI or MADRS scores"
15803360|NCT04423458|Device|3D imaging|"This project will concentrate on the accuracy and reliability of the advanced ultrasound applications in the evaluation of transplant kidney using duplex ultrasound, three-dimensional tomographic technique, shear wave elastography, and Angio-PLUS colour mode. Therefore, we intend to compare different medical imaging modalities between the ultrasound and the magnetic resonance imaging (MRI) in terms of sensitivity, specificity and diagnostic accuracy.
~The entire assessment should not take more than 35 minutes."
15803361|NCT04423445|Other|Laser acupuncture combined with acupressure|Participants received laser acupuncture on the six selected acupuncture points bilaterally twice a week for 4 weeks. A seed was taped onto each of the three points of the unilateral ear (initially, the left ear), where it remained for five days. Pressing on each of the seeds for one minute three times a day was required, but the stimulation intensity was adjusted depending on the participant's individual tolerance. The de qi sensation appears to be an established intervention efficacy indicator during auricular acupressure. After five days, the seed was removed, and a new seed was taped on the other ear.
15803362|NCT04423432|Other|Lower Extremity Resistance Exercise Training|3 times supervised exercise for 4 weeks Warm up (Self Paced walking for 10 minutes) leg press (8-12 RM) leg extension (8-12 RM) Sit to stand squat (with weight) Stationary Cycling (Maximum Resistance as per patient tolerance till failure)
15803363|NCT04423432|Other|Home Exercise Plan|"2 sets of 10 repetitions/day of
~AROM isolated knee extension and knee flexion
~Isometric isolated knee extension and knee flexion
~Isometric terminal knee extension
~Sit to stand squat
~terminal extension as Home Exercise Program (HEP). (Iwamoto J et al, 2007)"
15803364|NCT04423432|Device|Electrotherapy + Heating|Iinterferential Current therapy (2P), in combination with heating pad for 20 minutes
15803365|NCT04423432|Procedure|Joint Mobilization|"Tibio-femoral Anterior Glide
~Tibio-femoral Posterior Glide
~Patellofemoral Joint Mobilization"
15803366|NCT04423432|Dietary Supplement|Creatine Supplementation|Creatine Supplementation 20g/day for 1 week followed by 5 g/day for 3 weeks
15803367|NCT04423432|Dietary Supplement|Glucoseamine/ Chondritin Sulfate Supplementation|Glucoseamine/ Chondritin Sulfate Supplementation (500mg+400mg/day)
15803368|NCT04423419|Procedure|PENG block|The US probe placed in a transverse plane over the AIIS . the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 80-mm needle was inserted from lateral to medial to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anesthetic drug was injected while observing for adequate fluid spread for a total volume of 20 mL of Bupivacain 0.25%
15803509|NCT04422184|Drug|Dentalclean Daily Regenerator|Dentifricie with Refix technology
15803369|NCT04423419|Procedure|fascia iliaca block|ultrasound guidance landmarks are the anterior superior iliac spine and the pubic tubercle (inguinal ligament). The injection site along the lateral one-third of aline joining the anterior superior iliac spine (ASIS) and pubic tubercle (PT) targeting the compartment between fascia iliaca and fascia lata ,the total volume of injection is 20ml of Bupivacain 0.25%
15803370|NCT04423419|Other|IV analgesia|IV analgesia
15803371|NCT04423393|Biological|VIR-3434|VIR-3434 given by subcutaneous injection or intravenous infusion.
15803372|NCT04423393|Other|Placebo|Sterile normal saline (0.9% NaCl) given by subcutaneous injection or intravenous infusion.
15803373|NCT04423380|Drug|SH3051 capsule treatment|Starting dose 20mg,oral administered twice daily.If tolerated subsequent cohorts will test increasing doses (40mg,60mg,80mg,100mg) of SH3051.
15803374|NCT04423367|Drug|bortezomib/dexamethasone|Enrolled patients would receive the combination therapy of bortezomib and dexamethasone.
15803375|NCT04423354|Procedure|Transthoracic Single-hole Assisted Laparoscopic Radical Gastrectomy for Siewert Type Ⅱ Adenocarcinoma of Esophagogastric Junction|Patients diagnosed with Siewert Ⅱ adenocarcinoma of esophagogastric junction and met the inclusion criteria will be assigned to the research group and carry out transthoracic single-hole assisted laparoscopic radical gastrectomy by the fixed surgical group.The same model surgical instruments will be provided by the same instrument company.
15803376|NCT04423341|Drug|Cannabidiol Oral Solution [Epidiolex]|100 mg BID for three months Placebo oral solution for three months
15803377|NCT04423328|Behavioral|acupressure|self-acupressure
15803378|NCT04423302|Dietary Supplement|TOTUM-63 3 intakes per day|5-g dose of TOTUM-63 diet supplement, a mix of 5 plant extracts. Eight capsules per day to consume orally in three intakes (3 in the morning, 2 at lunch and 3 at dinner)
15803379|NCT04423302|Dietary Supplement|Placebo 3 intakes per day|Placebo. Eight capsules per day to consume orally in three intakes (3 in the morning, 2 at lunch and 3 at dinner)
15803380|NCT04423302|Dietary Supplement|TOTUM-63 2 intakes per day|5-g dose of TOTUM-63 diet supplement, a mix of 5 plant extracts. Eight capsules per day to consume orally in two intakes (4 in the morning and 4 at dinner)
15803381|NCT04423289|Other|Farmalarm|Monitoring after COVID-19 discharge from hospital via Farmalarm app
15803382|NCT04423276|Drug|Donepezil|Donepezil a cholinesterase inhibitor, 5mg(1 pill)/ day for 7 days Po, was administrated from the day before surgery.
15803383|NCT04423276|Drug|Placebo|Placebo, 1 pill/ day for 7 days Po, was administrated from the day before surgery.
15803384|NCT04423263|Procedure|Bilateral internal iliac artery balloon occlusion|Bilateral internal iliac artery balloon placement under fluoroscopic guidance preoperatively which will be occluded intraoperatively based on existing local protocol
15803385|NCT04423263|Procedure|Control|Surgical approach similar to intervention arm, except bilateral internal iliac artery occlusion
15803386|NCT04423250|Other|impact of the intervention of a clinical pharmacist with expertise in sterile medical devices on non-compliances related to the use of sterile medical devices|- Failure to trace, Lack of product information, absence of product in the operating room
15803387|NCT04423237|Drug|Deferasirox|DEFERASIROX administered as per clinical practice and according to technical note
15803388|NCT04423224|Other|GDFM|Stroke volume variation fluid management
15803389|NCT04423224|Other|USUAL CARE - CONTROL|Usual care fluid management
15803390|NCT04423211|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo 3D CRT
15803391|NCT04423211|Drug|Apalutamide|Given PO
15803392|NCT04423211|Procedure|Computed Tomography|Undergo PET/CT
15803393|NCT04423211|Radiation|External Beam Radiation Therapy|Undergo EBRT
15803394|NCT04423211|Radiation|Fluciclovine F18|Given IV
15803395|NCT04423211|Drug|Goserelin Acetate|Given SC
15803396|NCT04423211|Procedure|Intensity-Modulated Proton Therapy|Undergo IMPT
15803397|NCT04423211|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
15803398|NCT04423211|Drug|Leuprolide Acetate|Given IM
15803399|NCT04423211|Procedure|Positron Emission Tomography|Undergo PET/CT
15803400|NCT04423211|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15803401|NCT04423211|Radiation|Volume Modulated Arc Therapy|Undergo VMAT
15803402|NCT04423198|Behavioral|Cognitive Assessment|Self administered cognitive battery
15803403|NCT04423198|Behavioral|Patient Reported Neurological Outcome Assessments|Standard neurocognitive and neuropsychological tests
15803404|NCT04423198|Procedure|Blood Draw|Specimen collection of whole blood, serum, RNA
15803405|NCT04423185|Drug|Almonertinib 110 MG|Patients with advanced rare tumors who failed to standardized treatment carrying EGFR mutations will be administrated with Almonertinib.
15803406|NCT04423185|Drug|Dacomitinib 45 MG|Patients with advanced rare tumors who failed to standardized treatment carrying EGFR mutations will be administrated with Dacomitinib.
15803407|NCT04423185|Drug|Alectinib 150 MG|Patients with advanced rare tumors who failed to standardized treatment carrying ALK fusion will be administrated with Alectinib.
15803408|NCT04423185|Drug|Crizotinib 250 MG|Patients with advanced rare tumors who failed to standardized treatment carrying ALK fusion, ROS-1 fusion, C-MET amplification, C-MET mutation will be administrated with Crizotinib.
15803409|NCT04423185|Drug|Pyrotinib 160/80 MG|Patients with advanced rare tumors who failed to standardized treatment carrying HER-2 mutation or HER-2 over expression/amplification will be administrated with Pyrotinib.
15803410|NCT04423185|Drug|Imatinib 400 MG|Patients with advanced rare tumors who failed to standardized treatment carrying CKIT mutation will be administrated with Imatinib.
15803411|NCT04423185|Drug|Niraparib 200/300 MG|Patients with advanced rare tumors who failed to standardized treatment carrying BRCA1/2 mutation will be administrated with Olaparib.
15803412|NCT04423185|Drug|Palbociclib 125mg|Patients with advanced rare tumors who failed to standardized treatment carrying CDKN2A mutation will be administrated with palbociclib.
15803413|NCT04423185|Drug|Vemurafenib 240 MG|Patients with advanced rare tumors who failed to standardized treatment carrying BRAF mutation will be administrated with Vemurafenib.
15803414|NCT04423185|Drug|Sintilimab 100MG|Patients with advanced rare tumors who failed to standardized treatment carrying no targeted alterations will be administrated with Sintilimab.
15803510|NCT04422184|Drug|Dentalclean Daily Regenerator with potassium citrate|Dentifricie with Refix technology+ potassium citrate
15803415|NCT04423185|Drug|Atezolizumab 1680 MG|Patients with BRAF mutation treated with vemurafenib, after acquired resistance, will combine vemurafenib with atezolizumab.
15803416|NCT04423172|Device|the new tissue containment system|Using the new tissue containment system during Laparoscopic hysterectomy. The divice is a soft specimen bag in which the uterus tissue is sealed and quickly morcellation and removed through vagina. The divice is named the new tissue containment system.
15803417|NCT04423159|Biological|OCV Vaccine|2 doses of OCV were administered to all enrolled participants 1st dose administered at baseline and second dose administered 28 days post 1st dose.
15803418|NCT04423146|Other|The evocation of reproducible motor evoked potential according to the different BIS levels|The evocation of reproducible motor evoked potential and the actual value of amplitude and latency at different BIS levels (40 - 60) will be monitored.
15803419|NCT04423133|Behavioral|Online Family Literacy Program|Parent-child dyads will participate in 8 weekly online health-themed workshops that introduce language and literacy skills. Participants will also receive 2-3 text messages per week for the duration of the program and children's books.
15803420|NCT04423107|Drug|Acetaminophen, Ibuprofen|Acetaminophen (Tylenol) 15 mg/kg q6h and Ibuprofen (10 mg/kg) q6h
15803421|NCT04423107|Drug|Acetaminophen, Ibuprofen, Oxycodone|Acetaminophen (Tylenol) 15 mg/kg q6h, Ibuprofen q6h, and Oxycodone 0.1 mg/kg q6h
15803422|NCT04423081|Other|EXIT scale|completion of EXIT scale translated in french
15803423|NCT04423068|Behavioral|SexHealth II|SexHealth II is an intervention that will focus exclusively on provision of hormonal contraception counseling and provision for hospitalized female adolescents
15803424|NCT04423068|Drug|Contraceptive|"The investigators will offer initiation of the following contraceptives:
~Ethinyl Estradiol and Etonogestrel 0.015mg-0.12mg vaginal ring (Nuva Ring) Etonogestrel 68mg subcutaneous implant (Nexplanon) Medroxyprogesterone 150mg/ml 150 mg IM injection Ethinyl Estradiol and Norgestimate (Sprintec) 35mcg-0.25mg tablet Norelgestromin/Ethinyl estradiol transdermal patch (Ortho Evra) Norethindrone 0.35mg tablet
~Emergency Contraception:
~Ulipristal 30 mg tablet Levonorgestrel 1.5mg tablet"
15803425|NCT04423055|Drug|Etonogestrel contraceptive implant|Place etonogestrel contraceptive implant.
15803426|NCT04423042|Biological|Tocilizumab|Tocilizumab binds to both soluble and membrane-bound interleukin-6 receptors and has been shown to inhibit interleukin 6-mediated signalling.
15803427|NCT04423029|Biological|DF6002|DF6002 is a monovalent human interleukin-12 (IL12)-constant fragment (Fc) fusion protein that binds to the IL12 receptor.
15803428|NCT04423029|Biological|Nivolumab|Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody, which binds to the programmed death-1 receptor (PD-1).
15803429|NCT04423016|Device|Near Infrared Spectroscopy monitoring|Non-invasive continuous monitoring of cerebral oxygenation
15803430|NCT04423016|Device|Electrical velocimetry and pulse oximetry|Non-invasive continuous monitoring of cerebral oxygenation
15803431|NCT04423003|Procedure|Endoscopic intervention|All endoscopic interventions in COVID-19 positive tested patients were included
15803432|NCT04422990|Device|Lehfilcon A contact lenses|Investigational silicone hydrogel contact lenses
15803433|NCT04422990|Device|Comfilcon A contact lenses|Commercially available silicone hydrogel contact lenses
15803434|NCT04422977|Diagnostic Test|Sars-Cov-2 serology|Measurement of overall seroprevalence of SARS-Cov-2 in an hospital staff
15803435|NCT04422964|Device|3D Obturator|Based on this 3D visualization of precise anatomical conditions in the oral cavity, a form (negative unique impression of the upper jaw and palato-alveolar conditions) for casting of a protective obturator (splint), used during intubation to cover the defect of the alveolar arch and palate will be created on a 3D printer
15803436|NCT04422951|Behavioral|Wise interventions -- values self-affirmation and growth mindset|Addition of two wise wise social psychological interventions-growth mindset and self-affirmation-to a 6-month usual care online behavioral intervention for weight control in children with obesity
15803437|NCT04422951|Behavioral|Usual care online behavioral treatment|6-month usual care online behavioral intervention for weight control in children with obesity
15803438|NCT04422938|Other|Manuel chest compressions handled by clinicians|Compressions will be handled by human efforts
15803439|NCT04422938|Device|LUCAS™ 2 Chest Compression System|LUCAS-2 model piston-based mechanical chest compression device was used for mechanical chest compressions
15803440|NCT04422925|Procedure|Living Donor Hepatectomy|On living donor hepatectomy (preoperative), the first following day of surgery, 3rd day, and 7th day, blood will be taken for the measurement of S100β, NSE, and GFAP levels in the postoperative period. The plasma of the blood taken will be separated and stored at -800C. Values will be measured by the ELISA method. During the hospitalization, the delirium status of the patients will be evaluated with the delirium evaluation scale (Delirium Rating Scale-Revised - 98 Turkish version). Functional and cognitive information and other results will be collected at each follow-up point.
15803441|NCT04422912|Biological|DSG3-CAART|Intravenous infusions of DSG3-CAART at different doses and different fractionations
15803442|NCT04422899|Drug|AIV007|intravitreal
15803443|NCT04422886|Device|active transcranial direct current stimulation (tDCS)|20 minutes at 2.0 mA with electrodes positioned at Cz and Fpz (as per 10-20 electrode placement guidelines)
15803444|NCT04422886|Behavioral|Physiotherapy|motor skills based physiotherapy intervention (representative of typical goal-focused intervention in the clinical ABI program at Holland Bloorview), 45 minutes in duration
15803445|NCT04422886|Device|sham transcranial direct current stimulation (sham)|1 minutes at 1.0 mA with electrodes positioned at Cz and Fpz (as per 10-20 electrode placement guidelines) and 19 minutes with unit shut off and electrodes remaining on the scalp
15803446|NCT04422860|Drug|Gum Arabic varnish|Powdered exudate from various Acacia species, especially A. senegal (Leguminosae).
15803447|NCT04422860|Drug|Proflourid Varnish,VOCO|5% NaF varnish
15803448|NCT04422860|Drug|MI Varnish,GC Japan Inc.|CPP-ACP with fluoride based varnish
15803449|NCT04422847|Device|3D obturator|Based on this 3D visualization of precise anatomical conditions in the oral cavity, a form (negative unique impression of the upper jaw and palato-alveolar conditions) for casting of a protective obturator (splint), used during intubation to cover the defect of the alveolar arch and palate will be created on a 3D printer
15803541|NCT04421885|Drug|Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Reference|600 mg (2 x 300 mg tablets) clinical study drug product batch TBPM-PI-HBr.
15803450|NCT04422834|Other|Questionnaire|A group of students who studying at the Faculty of Health Sciences will be asked to fill the Turkish version of JSE-HPS and ETS. JSE-HPS will be asked to re-fill after seven days for retest analysis.
15803451|NCT04422821|Device|Flash Glucose Monitoring|Flash Glucose Monitoring FreeStyle Libre™ (Abbott Diabetes Care, Alameda, CA) sensor placed subcutaneously that will be applied for 14 days, then removed and changed for the second sensor for the next 14 days.
15803452|NCT04422821|Device|Self-Monitoring of Blood Glucose|Self-Monitoring of Blood Glucose with a standard glucose meter (iXell®; Genexo sp; Warsaw, Poland) performed through a skin-puncturing 4 times a day for 28 days.
15803453|NCT04422795|Device|External thermomechanical device delivering cold and vibration stimuli|the thermomechanical device will be placed on the digit 2 cm proximally to the injection site with the ice wings frozen and the vibration mechanism switched on, delivering vibration and cold stimuli to the area for 30 seconds before the intramatricial injection and until needle withdrawal
15803454|NCT04422795|Device|External thermomechanical device without delivering cold and vibration stimuli|the thermomechanical device will be placed on the digit 2 cm proximally to the injection site with the ice wings at unfrozen and the vibration mechanism switched off, for 30 seconds before the intramatricial injection and until needle withdrawal
15803455|NCT04422795|Drug|Ethyl chloride skin refrigerant spray|Ethyl chloride skin refrigerant spray is applied to the area of injection for 3 seconds immediately before needle insertion
15803456|NCT04422782|Other|For each routine sample, an additional tube will be collected to measure the osmotic pressure in the blood and urine|Interventional research protocol involving the human person category 2 at risk and minimal constraints
15803457|NCT04422756|Diagnostic Test|Seated intravenous saline infusion test|"The test will be conducted by infusing two litres of normal saline intravenously over 4 hours with the patient seated.Blood collection (for aldosterone, cortisol, renin, and electrolytes) will be performed at baseline and after completion of the infusion. Following infusion, plasma aldosterone levels <140 pmol/L will be considered as negative, levels >280 pmol/L as positive, and levels in between classified as indeterminate."
15803458|NCT04422756|Diagnostic Test|Ultra low-dose ACTH stimulation test|"The test will be performed by injecting 0.03 mcg of ACTH intravenously. Blood collection (for aldosterone, cortisol, and renin) will be performed at baseline and after 15 minutes. We expect a positive response to correspond with a plasma aldosterone >2200 pmol/L and ARR >220 pmol/L/mIU/L following stimulation."
15803459|NCT04422743|Dietary Supplement|Citicoline 500 mg plus Homotaurine 50 mg|Citicoline 500 mg plus Homotaurine 50 mg was added to topical therapy
15803460|NCT04422730|Behavioral|Psychological evaluation|Patients will be answer to validated test about how they feel. Psychological interview is also possible depending on patients availability. The different answers will be compared between the four groups
15803461|NCT04422704|Behavioral|Technology-based-Intervention|"The intervention is intended to address the concerns and needs that emerge from the participants' interviews. The intervention is based on the principles of the process of adaptation to retirement defined by Atchley and the Prochaska and Diclemente Model on the phases of preparation for retirement. The material to be used will be based on existing resources for retired people, awareness through multimedia material and knowledge of possible contributions of different technological devices to the retirement process.
~The sessions consisted of showing different exercises and devices to perform physical activities, cognitive training, relaxation activities, counselling about healthy eating and leisure-time activities."
15803462|NCT04422691|Diagnostic Test|Lung ultrasound|After verbal consent the enrolled patients' lungs are evaluated with ultrasound while in isolation. The lungs are divided into 3 fields and findings are categorized according to Soldati et al., 2020.
15803463|NCT04422678|Drug|Imatinib Mesylate|Adding treatment by imatinib oral tablet into the standard treatment for moderate to severe COVID-19 pneumonia.
15803464|NCT04422678|Drug|Standard of Care|Standard of Care for the Moderate to Severe COVID-19 Pneumonia as per the Egyptian National Protocol by the Ministry of Health.
15803465|NCT04422665|Other|Resistance exercise|Single-legged resistance exercise
15803466|NCT04422652|Drug|Bupropion|Bupropion is an anti-depressant medication.
15803467|NCT04422652|Behavioral|Behavioral activation therapy|Brief behavioral activation treatments administered via video tele-conferencing.
15803468|NCT04422652|Drug|Placebo|Double-blind placebo.
15803469|NCT04422652|Other|Clinical Management|Clinical management will serve as the attention control for the Behavioral Activation Therapy intervention.
15803470|NCT04422639|Radiation|SRS/SRT|Comparing pre-operative SRS/SRT to post-operative SRS/SRT
15803471|NCT04422613|Diagnostic Test|pulmonary anomalies 4 months after documented COVID-19 pneumonia|Characterization of pulmonary damage with a complete pulmonary assessment 4 months after COVID-19 pneumonia,
15803472|NCT04422587|Other|RECOP unit patient|All patients admit in RECOP unit for dyspnea can be included in this study if patient is agree. Then, doctor collects demographic variables, the usual history and treatments, the characteristics of the episode (symptomatology, evolution, treatment taken) and the data from the initial clinical examination will be identified.
15803473|NCT04422561|Drug|Ivermectin Tablets|two doses 72 hours apart
15803474|NCT04422548|Procedure|AI-assisted Colonoscopy|This is a multi-center prospective randomized controlled study comparing real-time AI-assisted colonoscopy versus standard colonoscopy in a real-life setting.
15803475|NCT04422548|Procedure|Standard Colonoscopy|Standard Colonoscopy
15803476|NCT04422509|Biological|lanadelumab|single dose, or two doses administered iv
15803477|NCT04422509|Other|regular care|no lanadelumab administration, treated according to regular care
15803478|NCT04422496|Drug|HEC96719|"single-Dose Study: Each dose of HEC96719 and placebo will be administered with approximately 240 mL of water in the morning after fasting for at least 10 hours overnight.
~multiple-dose study:The study doses, administration method (fasted or fed), dosing frequency, and dosing period are all to be determined based on data from the single-dose study and multiple-dose study."
15803511|NCT04422158|Dietary Supplement|Nuun electrolyte tablet|Each table contains 2 grams of carbohydrate and a combination of electrolytes. calcium (13mg, 1%DV), sodium (300mg, 13%DV), potassium (150mg, 3%DV), magnesium (25mg, 6%DV), and chloride (40mg, 2%DV).
15803512|NCT04422158|Other|water|water
15803542|NCT04421885|Drug|Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) - Test|600 mg (2 x 300 mg tablets) registration drug product batch TBPM-PI-HBr.
15803479|NCT04422483|Other|Realist evaluation|In-depth exploration of individual service models will be carried out to determine the interrelationship of context, intervention, mechanisms and outcomes as they occur in their natural setting. Data will be gathered within case studies using mixed methods at two levels: (i) service model and (ii) individual child/ family. Methods will include semi structured realist Interviews, focus groups, and document reviews to assemble a comprehensive description of the service and model. Interviewees will include commissioners, service managers, clinicians, referrers, parents and young people. Interviews will be recorded and transcribed, proceeding to qualitative analysis based on components of the programme theory. Regular team meetings will discuss coding, address inconsistencies, and refine collective understanding of coding framework. Coded data will be collated using NVivo software.
15803481|NCT04422457|Other|68Ga-DX600 PET/CT|DX600, labeled with 68Ga will be used as a molecular imaging tracer for PET/CT scanning
15803482|NCT04422444|Diagnostic Test|Questionnaires|Participants will answer questionnaires in three areas: physical/functional, emotional status and cognitive status
15803483|NCT04422431|Drug|Bis-Choline Tetrathiomolybdate|Participants will be initiated at 15 milligrams once daily, then the dose will be increased to 30 milligrams once daily at Week 6.
15803484|NCT04422405|Procedure|One Anastomosis Gastric Bypass (OAGB)|"The procedure is performed laparoscopically. The GIA stapler divides the stomach at the junction of the body and antrum. An Ewald tube, roughly the diameter of the esophagus, is passed by the anesthetist and held against the lesser curvature. The division of the stomach against the tube is completed, with 5- 6 lines of staples. The division of the stomach is parallel to the lesser curvature and up to the angle of His. A point is selected on the small bowel about 200 cm distal to the ligament of Treitz. The jejunal loop is brought up antecolic, and the Endo-GIA stapler is used to perform the anastomosis between the stomach and the small bowel at this point. The distal end of the gastric tube is anastomosed to the side of the small bowel."
15803485|NCT04422392|Drug|Carboplatin|(IV, Q3W)
15803486|NCT04422392|Drug|Pemetrexed or Nab-paclitaxel|Pemetrexed (Nonsquamous NSCLC) or Nab-paclitaxel (Squamous NSCLC) (IV, Q3W)
15803487|NCT04422392|Drug|PD-1 antibody|(IV, Q3W)
15803488|NCT04422366|Biological|9-valent Human Papillomavirus (Types 6, 11, 16, 18,31,33,45,52 and 58) Recombinant Vaccine (Hansenula Polymorpha)|Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.
15803489|NCT04422366|Biological|GARDASIL®|Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule
15803490|NCT04422353|Other|Video Dance classes|The dance program consists of dance lessons inspired by Forró rhythm and Samba rhythm. The classes will be held through a recorded video that must be played twice a week. Each video class lasts 30 minutes.
15803491|NCT04422353|Other|Unsupervised physical activities|The classes will be held through a recorded video that must be played twice a week. Each video class lasts 30 minutes.
15803492|NCT04422340|Other|Group1|"Comorbidities (CIRS-G scale),
~Functional status of the patient with
~Clinical frailty scale (1 month before infection)
~ADL score (1 month before infection)
~Biological data
~Blood group
~TP, D-dimers, CRP, creatinine level at the patient's entry, triglyceridemia, fibrinogen, ferritin
~Parameters derived from the platelet formula count on D1 of the start of intensive care (lymphocytes, neutrophils, platelets, average platelet volume, red blood cell distribution index), SYSMEX data (IG: Immature granulocytes; HFLC: high fluorescent lymphocyte count)
~Resuscitation outcomes
~LDH rate at the start of intensive care
~PaO2 / FiO2 ratio at the start of intensive care
~IGSII / SASPII score (simplified acute physiology score) on D1 of the start of intensive care
~SOFA score (sepsis-related organ failure assessment): a posteriori estimate based on IGSII / SASPII
~Delay between the appearance of the first signs of infection and admission to intensive care"
15803493|NCT04422327|Dietary Supplement|Probiotic capsule|"Each probiotic capsule contains 5 x 10^8 CFU B. longum 35624® and 5 x 10^8 CFU B. longum 1714™ with corn starch and magnesium stearate.
~The probiotic capsule will be supplied by PrecisionBiotics Ltd."
15803494|NCT04422314|Diagnostic Test|T-Detect Lyme|T-Detect Lyme is an investigational use test that uses multiplex PCR and NGS to assess rearranged T-cell receptor beta (TRB) gene sequences from genomic DNA isolated from human peripheral blood.
15803495|NCT04422301|Other|Blood flow restriction|an alternative method to produce strength and muscle hypertrophy with lower intensities
15803496|NCT04422275|Drug|Budesonide|The drug intervention budesonide (0.5 mg /capsule) will be dissolved in 240 ml nasal saline lavage.
15803497|NCT04422275|Behavioral|High-Concentration Essential Oil|High-concentration essential oil will include 1 ml of essential oil per jar.
15803498|NCT04422275|Drug|Placebo|The placebo (lactose monohydrate) drug will be dissolved in 240 ml of nasal saline lavage.
15803499|NCT04422275|Behavioral|Low-Concentration Essential Oil|Low-concentration essential oil will include 0.1 ml of essential oil per jar.
15803500|NCT04422249|Procedure|laparoscopic middle hepatic vein guidance anatomic hemihepatectomy|95 patients with primary HCC were divided into the middle hepatic vein guidance group(n=45) and the traditional group(n=45) according to the odd and even Numbers, and sealed into envelopes.Outcomes were monitored and evaluated during the 3-year follow-up period
15803501|NCT04422236|Device|easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)|Investigational device: easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical). Device for creation of anastomoses during laparoscopic bariatric surgery, manufactured by Ezisurg Medical.
15803502|NCT04422210|Drug|Venetoclax|Venetoclax will be administered orally at escalating doses from 200mg to 800mg as 100mg tablets as per the dosing schedules described above.
15803503|NCT04422210|Drug|Atezolizumab|Atezolizumab will be administered via intravenous (IV) infusion at a fixed dose of 1200mg as per the dosing schedules described above.
15803504|NCT04422210|Drug|Carboplatin|Carboplatin will be administered via IV infusion at a dose of 5mg/mL/min as per the dosing schedules described above.
15803505|NCT04422210|Drug|Etoposide|Etoposide will be administered via IV infusion at a dose of 100mg/m^2 as per the dosing schedules described above.
15803506|NCT04422197|Biological|Botox|effect of botox injection in abdominal wall muscle post major abdominal surgery in terms of postoperative pain, incidence of incisional hernia.
15803507|NCT04422197|Procedure|surgery without botox injection|surgery without botox injection
15803508|NCT04422184|Drug|Sensodyne Repair and Protect|Dentifricie with NOVAMIN technology
15803540|NCT04421911|Drug|Diclofenac Topical|Diclofenac topical for 21days
15803513|NCT04422145|Behavioral|Structured nurse led intervention programme|A diabetes research nurse, over a period of 12 months, provided a structured education programme to participants focussing on the avoidance of hypoglycaemia and the treatment of this if/when it occurred.
15803514|NCT04422145|Other|Standard care|Participants continue on their current diabetes care plan and are looked after by their usual diabetes care provider
15803515|NCT04422132|Radiation|5 days Radiation Therapy (32.5 Gy in 5 fractions)|Patients will receive treatment to the prostate fossa +/- nodes in either 32.5 Gy in 5 fractions or 55 Gy in 20 fractions.
15803516|NCT04422132|Radiation|20 days Radiation therapy (55 Gy in 20 fractions)|Patients will receive treatment to the prostate fossa +/- nodes in either 32.5 Gy in 5 fractions or 55 Gy in 20 fractions.
15803517|NCT04422119|Procedure|Multi-Foam dressing|Application of a multi-layer foam dressing with Safetac in surgical wound
15803518|NCT04422119|Procedure|Usual care|Care of surgical wound with povidone-iodine and a gauze dressing with plaster.
15803519|NCT04422106|Diagnostic Test|Predictors of intestinal anastomosis leakage, application of new predictors and new scores|Early detection of disruption and leakage of intestinal anastomotic sites whether small or large intestine by using biochemical markers as predictors and indicators of leakage with application of scoring scale to assess presence or absence of leakage.
15803520|NCT04422093|Device|OrthoKontrol|Fixing OrthoKontrol Sensor on multibracket appliance to measure cooperation
15803521|NCT04422067|Other|Fetal cephalometry|Fetal cephalometry
15803522|NCT04422054|Procedure|Open Surgery|We will retrospectively review patients with abdominal aortic aneurysms that underwent open surgical repair.
15803523|NCT04422054|Procedure|Endovascular Surgery|We will retrospectively review patients with abdominal aortic aneurysms that underwent endovascular repair.
15803524|NCT04422041|Other|Time to discharge less than 24 hours|Allow the joint medical discharge of the newborn together with its mother in less than 24 hours after birth in a healthy patient, without obstetric complications and who does not present comorbidities and complications.
15803525|NCT04422041|Other|Discharge time between 24 and 48 hours|Allow the joint medical discharge of the newborn together with its mother between 24-48 hours after birth in a healthy patient, without obstetric complications and who does not present comorbidities and complications.
15803526|NCT04422028|Drug|Desogestrel 0.075 MG|Test Drug
15803527|NCT04422028|Drug|Desogestrel 0.075 MG|Reference Product
15803528|NCT04422015|Other|No intervention|No intervention
15803529|NCT04421989|Behavioral|Emotion Coaching|Participants randomized to FBT + EC parent group condition will also receive FBT as part of their standard of care. In addition to FBT, they will receive 10 additional, weekly, parent group sessions (each session is 60 minutes, 6-8 group members), within a 3-month time frame to account for cancellations. The EC intervention is designed to reduce expressed emotion (e.g., critical comments) and increase parental warmth. The intervention includes emotional awareness and emotion regulation skills for parents, and emotion communication skills for parents to use with their teens undergoing FBT including active listening, emotion support, labeling emotions, and coping with emotions. The structure of EC parent group sessions will begin with review of homework as applicable, a didactic component to teach new skills, followed by role plays between parents in the group and interventionist, and live coaching and feedback from the interventionist.
15803530|NCT04421989|Other|Support Group|Participants randomized to FBT + Support Group parent group condition will also receive FBT as part of their standard of care. In addition to FBT, they will receive 10 additional, weekly, parent group sessions (each session is 60 minutes, 6-8 group members), within a 3-month time frame to account for cancellations. The support group will have a facilitator introduce each topic weekly and parents will discuss. The facilitator's role is to ensure the group remains on topic and on time. Weekly discussion topics include: co-morbid medical diagnoses, understanding levels of care in treatment, taking time off from work, and medications.
15803531|NCT04421976|Procedure|PEEP|"Driving pressure (DP) is calculated as plateau pressure - PEEP. 10min after position adjustment, PEEP is increased from 2 to 10 cm H2O incrementally. Each PEEP level is maintained for 10 respiratory cycles, with DP in the last cycle recorded. Then the PEEP level producing the lowest DP will be identified and maintained intraoperatively."
15803532|NCT04421963|Drug|Olaparib|300 mg olaparib (2×150 mg tablets) twice daily
15803533|NCT04421950|Dietary Supplement|Wild blueberry containing foods|Foods that contain wild blueberry supplement to deliver up to 30 grams of blueberry powder
15803534|NCT04421950|Dietary Supplement|Placebo containing foods|Foods that do not contain the blueberry powder but a placebo
15803535|NCT04421937|Behavioral|Procedure: Traditional Dysphagia Therapy (TDT)|"Traditional dysphagia therapy includes diet modification training, teaching postural compensatory methods, training of oral motor control exercises and tongue root exercises, training of swallowing maneuvers, and practice of chin-resistance exercise, which is the exercise of opening the upper esophageal sphincter.
~Traditional Dysphagia Therapy will be applied for 45 minutes a day, 5 days a week for 3 weeks."
15803536|NCT04421937|Device|Procedure: Neuromuscular Electrical Stimulation with TDT|The skin to be treated will be cleaned and dried. NMES will be implemented with signals received from two channels. In the first channel, the upper electrodes will be placed horizontally just above the hyoid bone. This is the place where the cupping is felt when the finger is pressed right under the chin. In the second channel, the lower electrodes will be placed horizontally, just above the thyrohyoid muscle. This is the place where you can feel a cupping when pressed with your finger, on both sides of the apple in the larynx. The device will be set to start at the lowest power, with very short pulses of approximately 700 microseconds, at intervals of 1 second. The power will be gradually increased according to the device and the power that the patient feels vibration will be stopped. The power to be applied will not exceed 25 milliamps. NMES application and Traditional Dysphagia Therapy will be applied for 45 minutes a day, 5 days a week for 3 weeks.
15803537|NCT04421924|Procedure|thrombelastogram|Patients in the TEG group will receive prothrombin complex concentrates (PCC) at a dose of 10 IE/kg of ideal body weight, when R-time was greater than 40 minutes (2400 sec) and they will receive platelet transfusion in the amount of 1 apheresis unit when MA was below 30 mm
15803538|NCT04421924|Procedure|standard of care|2) In the SOC group, patients will receive PCC at the dose of 10 IE /kg of ideal body weight when the PT is below 50% and/or INR>1.8 and/or received platelet transfusion in the amount of 1 apheresis when platelet count is below 50 G/L
15803539|NCT04421911|Drug|Ketoprofen topical|Ketoprofen topical for 21days
15803544|NCT04421859|Other|EyeCU Mobile Application|Augmented reality glaucoma education mobile phone application
15803545|NCT04421846|Other|Blood sampling, cerebrospinal fluid , post-mortem cerebral tissues (NA for the Group 3)|Collection of biological samples and clinical/paraclinical data
15803546|NCT04421833|Behavioral|TOVERTAFEL|"The TOVERTAFEL is a small box that can be attached to the ceiling. Inside the box is a high-quality projector, infrared sensors, a speaker, and a processor that work together to project games onto the table. Because the colored objects respond to the movements of the hands and arms, the residents can play with the light itself.
~The planned activities provide cognitive, social and physical stimulation through light projections and can all be used individually or in groups with the presence of a caregiver or facilitator. Sixteen play activities are offered."
15803547|NCT04421833|Behavioral|USUAL activities|"patients can participate in cooking workshops, cinema activities (screening of old films or documentaries on a large screen, in a cozy atmosphere), walks in the garden and the visit of a dog trained in assisted therapy by the animal."
15803548|NCT04421820|Drug|BOLD-100 in combination with FOLFOX Chemotherapy|320 mg/m2 IV over 30 minutes, q2weeks; 420 mg/m2 IV over 30 minutes, q2weeks; 500 mg/m2 IV over 30 minutes, q2weeks; 625 mg/m2 IV over 30 minutes, q2weeks
15803549|NCT04421807|Other|Scapulatoracic stabilization exercises|Scapulatoracic stabilization exercises consisted of 3 phases; the warming phase which consists of mobility and stretching; exercise phase consisting of static, dynamic and functional phase; the cooling phase consisting of mobility and stretching. Scapulatoracic stabilization exercises additionally applied to CDT were performed 3 days a week for 8 weeks. These exercises were specially planned for the patients and applied gradually
15803550|NCT04421807|Other|Complex decongestive therapy (CDT)|In the treatment phase of CDT, manual lymph drainage, skin care, compression bandage, draining exercise were applied 5 days a week for 3 weeks. Compression socks, self-drainage, skin care and unloading exercises were applied for 5 weeks in the protection phase of CDT. Thus, patients were followed up with the CDT program for 8 weeks.
15803551|NCT04421794|Device|NMES|Neuromuscular Electrical Stimulation (NMES) is a non pharmacological intervention that sends electrical impulses to nerves leading to muscle contraction. The electrical stimulation can increase strength and is often used to re-educate or re-train muscles.
15803552|NCT04421794|Device|TENS|Transcutaneous electrical nerve stimulation (TENS) is a nonpharmacological intervention that activates a complex neuronal network to reduce pain by activating descending inhibitory systems in the central nervous system to reduce hyperalgesia.
15803553|NCT04421781|Other|Retrospectively review of medical data in patients treated by Salvage HIFU for isolated macroscopic recurrence in the prostatic bed after radical prostatectomy and salvage or adjuvant EBRT|Patients were treated using dedicated post-EBRT parameters (5-s pulse, 5-s waiting period, 90% of the acoustic power). Between July 2005 and November 2018, at Edouard Herriot Hospital (Lyon, France), 22 consecutive patients were treated with S-HIFU for a local recurrence after RP and salvage or adjuvant EBRT. The oncological outcomes (treatment failure-free survival, progression-free survival), the adverse events and urinary incontinence were retrospectively reviewed.
15803554|NCT04421768|Behavioral|cervical exam training|During the first week of the study they will also examine 10 rigid clay followed by 10 foam cervices in the PVC pipe- based cervical models. Each nurse will then examine 1 sets of 10 high-fidelity silicone task trainers approximately three per week for a maximum of 20 sessions (200 repetitions total). For each set of 10 exams, the estimates will recorded on an answer sheet. A cumulative summation analysis will be performed on each participant. When an individual nurse achieves competence her training will be suspended
15803555|NCT04421755|Other|Produce delivery|weekly home delivery of fresh fruits and vegetables
15803556|NCT04421755|Other|Cooking classes|weekly home delivery of fresh fruits and vegetables participants will be invited to participate in a Culinary Medicine cooking series. The OU Culinary Medicine cooking curriculum will involve a 3-part class series designed to build nutrition knowledge and cooking self-efficacy for preparing fresh F/Vs. Each session is ~2 hr. Core nutrition guidelines for blood pressure and blood sugar management will also be emphasized informed by an evidence-based Conceptual Model of Healthy Cooking. Classes will be conducted in small groups (~16 participants) in an established teaching kitchen used by the culinary medicine program. Classes will be facilitated by a professional chef, a healthcare professional (dietitian, medical doctor, or trained medical student), and other support staff, including trained medical, dietetic, and public health students.
15803557|NCT04421742|Drug|Beclomethasone Dipropionate/Formoterol Fumarate|BDP/FF NEXThaler® 100/6 μg b.i.d.
15803558|NCT04421729|Behavioral|Group sessions over 3 weeks|Informational and educational group-mediated program for family members caring for a person living with dementia; 6 sessions.
15803559|NCT04421729|Behavioral|Group sessions over 6 weeks|Informational and educational group-mediated program for family members caring for a person living with dementia; 3 sessions.
15803560|NCT04421716|Drug|Ursolic Acid|Ursolic Acid 150mg
15803561|NCT04421716|Drug|Curcumin|Curcumin 600mg
15803562|NCT04421703|Behavioral|Med-South Lifestyle Program|The Med-South Lifestyle Program is an evidence-based behavior change intervention that translates the PREDIMED (Mediterranean) dietary pattern for a Southeastern US population and includes support for increased physical activity.
15803563|NCT04421690|Behavioral|Cognitive Training|Participants (n=15) will complete computerized cognitive training games and activities online 3 times/week for 8 weeks.
15803564|NCT04421690|Behavioral|Trivia Training|Participants (n=15) will receive computerized trivia questions to answer and submit 3 times/week for 8 weeks.
15803565|NCT04421677|Drug|Phenylbutyrate Oral Tablet|Phenylbutyrate, an orally active chemical chaperone approved by the US Food and Drug Administration for treatment of urea cycle disorders, mimics the function of intracellular molecular chaperones in preventing protein aggregation and oligomerization.
15803566|NCT04421664|Drug|Hydroxychloroquine|200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days
15803567|NCT04421664|Drug|Placebo oral tablet|4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days
15803568|NCT04421651|Behavioral|Dance Movement Therapy group|DMT-intervention was facilitated by a dance movement therapist and included 20 x 75 mins sessions within 10 weeks.
15803594|NCT04421417|Procedure|Microfracture + Standard Arthroscopic Rotator Cuff Repair|drilling of rotator cuff footprint area on humerus and standard arthroscopic rotator cuff repair
15803569|NCT04421625|Diagnostic Test|Diagnostic test for SARS-Cov2 for patients and health staff|"Diagnostic test for SARS-CoV2 :
~Blood test to analyse the IgG and IgM with an immediate qualitative analysis (serological test) and a differed quantitative analysis (ELISA test)
~Results of nasal swab that will allow extracting the RNA and realizing a RT-PCR (only if the participants present symptoms). It will be obtained by standard local laboratories.
~Questionnaires (based on serology, clinic, economy (socio-demographic and lifestyle questionnaire) and epidemiology)"
15803570|NCT04421612|Behavioral|Co-mestring (co-coping)|8 modules with the aim to reduce stress, increase coping of social isolation and coping with the consequences of reduced positive experiences
15803571|NCT04421599|Other|The Necessity of Aspiration|"The patients who met the inclusion criteria and agreed to participate in the study were assigned to the Experimental Group A who were administered IM injection during which aspiration lasted for 5-10 seconds, to the Control Group who were administered IM injection during which aspiration lasted for 1-2 seconds, and to the Experimental Group B who were not administered IM injection according to the stratified block randomization list. The same Intramuscular Injection Application Protocol was applied while all the injections were administered."
15803572|NCT04421586|Behavioral|VISTA|VISTA will be an educational intervention.
15803573|NCT04421573|Procedure|BCPHD with D5W|D5W is injected under the investing fascia of the sternocleidomastoid muscle (SCM) using ultrasound guidance in order to infiltrate the space containing the cervical plexus. This is performed on both sides.
15803574|NCT04421573|Procedure|Waiting period with usual care|Same as previous group description
15803575|NCT04421560|Drug|Ibrutinib|Capsule, taken by mouth daily
15803576|NCT04421560|Drug|Pembrolizumab|Given as an intravenous injection through a vein (IV) every 3 weeks
15803577|NCT04421560|Drug|Rituximab|Given as infusion into a vein (intravenous, IV)
15803578|NCT04421547|Drug|Letrozole 2.5mg|This study will investigate the role of Letrozole in patients affected by heavily pretreated platinum resistant ovarian cancer, compared to standard treatment.
15803579|NCT04421547|Drug|Standard single agent chemotherapy|Either Paclitaxel 80 mg/m2 as a 1-h infusion, on days 1,8,15,22 every 28 days or Pegylated Liposomal Doxorubicin (PLD) 40 mg/m2 given every 4 weeks or Topotecan 4mg/m2 IV on days 1,8,15 every 4 weeks or Gemcitabine 1000 mg/m2 IV over 30 min on days 1,8,15 every 28 days.
15803580|NCT04421534|Drug|Lactoferrin|adding lactoferrin to standard of care treatment regimens
15803581|NCT04421521|Procedure|Acupuncture|Acupuncture with disposable needles will be implemented
15803582|NCT04421508|Combination Product|INOpulse|Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula.
15803583|NCT04421508|Combination Product|Placebo|Subjects will be treated by means of an INOpulse device using an INOpulse nasal cannula.
15803584|NCT04421495|Drug|Delamanid|the eligible patients will be give damanid-containing regimen
15803585|NCT04421482|Other|Standard room temperature (RTS) feeding of milk/formula|Evaluate the infant's sucking, swallowing, and breathing patterns using a non-invasive FDA approved equipment (nFant® Feeding Solution) under two separate feeding conditions: standard room temperature (RTS) and cold temperature (CS, at 4-9°C) of milk/formula for an entire feeding (15-20 minutes). The two feedings will be done on the same day but may not necessarily be two consecutive feedings (depending on the baby's eagerness to feed orally). The order of each condition will be randomized to control for fatigue.
15803586|NCT04421482|Other|Cold temperature (CS, at 4-9°C) of milk/formula|Evaluate the infant's sucking, swallowing, and breathing patterns using a non-invasive FDA approved equipment (nFant® Feeding Solution) under two separate feeding conditions, standard room temperature (RTS) and cold temperature (CS, at 4-9°C) of milk/formula for an entire feeding (15-20 minutes). The two feedings will be done on the same day but may not necessarily be two consecutive feedings (depending on the baby's eagerness to feed orally). The order of each condition will be randomized to control for fatigue.
15803587|NCT04421469|Drug|Triprilimab(JS001)|"JS001 240mg d1, gemcitabine(1g/m²),d1,8 + nedaplatin (80-100mg/m²),d2,q3w,6cycles.The curative effect was evaluated every 2 cycles.If the therapeutic evaluation was SD,the chemotherapy scheme was changed;
~Local treatment of active lesions(including radiotherapy and/or radiofrequency ablation);
~JS001 maintenance treatment."
15803588|NCT04421456|Drug|GWP42003-P|oral solution containing 100 milligrams per milliliter (mg/mL) cannabidiol (CBD) dissolved in the excipients sesame oil and anhydrous ethanol (10% v/v), with sweetener (sucralose), and strawberry flavoring
15803589|NCT04421456|Drug|Placebo|oral solution containing the excipients sesame oil and anhydrous ethanol, with added β-carotene, sweetener (sucralose), and strawberry flavoring
15803590|NCT04421443|Behavioral|Unified Protocol for Transdiagnostic Treatment of Emotional Disorders|This intervention focuses on a wide range of emotional psychopathology, allowing care for comorbid disorders and subclinical or unspecified symptoms, which reduces treatment times and costs, and improves response to treatment. The intervention will be carried out in an online-group format. For ethical reasons, if any of the patients feel uncomfortable during the study with the online-group format, will may leave the group and receive individual attention. The study plans follow-ups every three months until two years after post-treatment, all of them will be conducted online.
15803591|NCT04421430|Other|Distraction cards|The distraction cards contain various hidden pictures and patterns which are visible only when looked at carefully. During a procedure, the child is expected to focus on the cards and answer the questions asked about what they see in them. Just before the venipuncture, the researcher showed the distraction cards participants the distraction cards and asked them to check them and then asked them questions about what they saw on the cards and kept asking questions until the end of the venipuncture. The distraction cards intervention and venipuncture were terminated at the same time.
15803592|NCT04421430|Other|Virtual reality|The virtual reality participants put on the virtual reality glasses and headsets about two minutes before the venipuncture and watched the 3D Dinosaur Animation movie throughout the procedure. The virtual reality intervention and venipuncture were terminated at the same time.
15803593|NCT04421430|Other|Buzzy|Buzzy® applies high frequency vibration and concentrated cold at injection site for procedural pain management and distraction before the shot in children and adults. Buzzy® was placed on the injection site (antecubital fossa) of the Buzzy® participants, and cold application and vibration was turned on 60 seconds before the procedure. After the 60 seconds, the nurse moved Buzzy® about 3 cm above the injection site and applied a tourniquet and performed the procedure. Buzzy® was on throughout the procedure. The Buzzy® intervention and venipuncture were terminated at the same time.
15803595|NCT04421417|Procedure|Standard Arthroscopic Rotator Cuff Repair|Standard Arthroscopic Rotator Cuff Repair
15803596|NCT04421404|Biological|COVID-19 Convalescent Plasma (CCP)|COVID-19 Convalescent Plasma (CCP) is a form of passive antibody therapy that involves the administration of anti-SARS-CoV-2 antibodies to a susceptible individual for the purpose of preventing or treating the infectious disease it causes. Convalescent plasma for this trial will be obtained from Vitalant (or American Red Cross if necessary). Patients identified as having recovered from COVID-19 will serve as potential donors. Potential donors will be screened using an anti-SARS-CoV-2 serologic assay and antibody levels will be determined.
15803597|NCT04421404|Biological|Placebo|Standard plasma will be obtained from Vitalant (or American Red Cross if necessary) and will be either collected prior to 12/1/2019 or tested and confirmed to be negative for anti-SARS-CoV-2.
15803598|NCT04421391|Dietary Supplement|QuadraMune(TM)|QuadraMune(TM) is a commercially available nutritional supplement
15803599|NCT04421378|Drug|Selinexor|Dose and Formulation: 20 milligram (mg); Tablet Route of Administration: Oral
15803600|NCT04421378|Drug|Temozolomide (TMZ)|Dose strength and Formulation: 5, 20, 100, 140, 180, or 250 mg; Capsule Route of Administration: Oral
15803601|NCT04421378|Drug|Lomustine (CCNU)|Dose and Formulation: 10, 40, or 100 mg; Capsule Route of Administration: Oral
15803602|NCT04421378|Radiation|Standard Fractionated Radiation therapy (RT)|Radiation Therapy Oncology Group (RTOG) or European Organisation for Research and Treatment of Cancer (EORTC) methodologies of approximately 60 Gy in 30 fractions.
15803603|NCT04421378|Drug|Bevacizumab|Dose and Formulation: 10 mg/kg; Route of Administration: Intravenous
15803604|NCT04421378|Device|TTField|Dose and Formulation: 200 kHz ≥18h/day; Route of administration: Scalp application of transducer arrays.
15803605|NCT04421378|Drug|Carmustine|Dose and Formulation: 150 or 200 mg/m^2; Route of Administration: Intravenous
15803606|NCT04421365|Device|neurofeedback brain-computer interface (BCI)|The integrated components of BCI system include the high-density 128-electrode EEG acquisition system (EGI Geodesic EEG System 400 with EGI HydroCel Geodesic Sensor Net, Philips), 3D-VR goggles (HTC Vive Pro), and a built-in ML platform as a real-time neural signal decoder and neurofeedback controller.
15803607|NCT04421352|Drug|CS1001|"low-dose radiation+CS1001 1200mg Q3W. In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme.
~Dose A: 3Gy/1f; Dose B: 9Gy/3f; Dose C: 15Gy/5f;
~In the dose expansion part, more SCLC patients will be assigned."
15803608|NCT04421339|Dietary Supplement|Melatonin|Participants will receive melatonin 5 mg once a day (30 min prior to bedtime) for four weeks, followed by one-week washout before crossing-over.
15803609|NCT04421339|Other|Placebo|Participants will receive placebo once a day (30 min prior to bedtime) for four weeks, followed by one-week washout before crossing-over.
15803610|NCT04421326|Other|Analysis of the clot|Blood sampling at the site of intracranial occlusion during Mechanical Thrombectomy
15803611|NCT04421313|Drug|Dietary Fiber Supplementation|12 g of inulin or of maltodextrin in powder, to dilute in water once daily, during 1 month. Given in pre-weighted pots (one pot per day, similar color and aspect)
15803612|NCT04421300|Behavioral|smile exercise|"Launch the smile face recognition APP on smart phone, after user guidance and pretest, a smile exercise will display on the phone, while facing the front camera on the phone, participant will do an exercise emphasizing facial movements, as exaggerated as possible. The exercise last for 8 weeks and 4 times a day"
15803613|NCT04421300|Drug|0.1% sodium hyaluronate eye drop|0.1% sodium hyaluronate, 4 times a day, the time is in the morning, lunchtime, afternoon and evening. the interval between two training time is 2 hours, 1 hour before and after can be added or subtracted by users, 8 weeks.
15803614|NCT04421287|Drug|Zhenyuan capsule|0.25g/ tablets, 2 tablets / TID, for 12 weeks
15803615|NCT04421274|Biological|Bone marrow mesenchymal stem cells transfer|Inject the BM-MSCs into the infarct-related arterial hypertension through the central cavity of the guide wire balloon catheter under the complete blockage of the target blood vessel. Each time the balloon continues to fill for 2 minutes to block blood flow, then resume perfusion for 2 minutes. The above process is repeated 6 ~ 8 times
15803616|NCT04421274|Drug|Best medical treatment|Refer to the latest medication guidelines and give the best medication to the patients
15803617|NCT04421274|Procedure|Percutaneous coronary intervention|Percutaneous coronary intervention
15803618|NCT04421261|Device|Air-Q Self Pressurized Airway Device with Blocker|used in low risk adult females undergoing elective surgeries
15803619|NCT04421261|Device|I-Gel|used in low risk adult female patients undergoing elective surgeries
15803620|NCT04421235|Behavioral|Childbirth support|"There are 5 program components that women may receive as a part of childbirth support:
~Prenatal education - consists of up to 8 sessions of education on pregnancy, childbirth, and postpartum health and wellness.
~Support group - semi-structured group which provides time for women to process their pregnancy and postpartum-related experiences with other women facing similar challenges. Integrates mindfulness exercises, cognitive-behavioral skills, and special topics as requested by group members.
~Lactation program - program for women who wish to provide breastmilk for infants from which they are separated.
~Doula support program - 2 prenatal and 2 postnatal individual visits with a doula who will also provide continuous childbirth support and support during separation from infants.
~Parenting classes - group classes focused on helping women learn parenting skills and (if applicable) meet state requirements for reunification with children"
15803621|NCT04421222|Drug|EPI-7386 (QD)|Once daily oral dose of EPI-7386
15803622|NCT04421222|Drug|EPI-7386 (BID)|Twice daily oral dose of EPI-7386
15803623|NCT04421209|Drug|Propranolol Hcl 40mg Tab|40mg PO BID for the three days prior to surgery, 40mg PO BID the day of surgery and on post-op days 1 and 2.
15803624|NCT04421209|Drug|Placebo oral tablet|Placebo tablets administered with the same schedule of Propranolol tablets
15803625|NCT04421196|Other|Exclusion of opioid analgesics|The intervention involves removing the option of patients having an opioid analgesic at any time point during the perioperative period.
15803626|NCT04421183|Diagnostic Test|draw blood|draw blood from the all of patients
15803627|NCT04421170|Behavioral|smartphone app for smoking cessation|Paticipants will receive 12-week app-based smoking cessation intervention with follow-up to 26 weeks.
15803682|NCT04420806|Other|Sham intervention|Types of exercise (flexibility, relaxation) that did not affect the present outcomes
15805521|NCT04405206|Procedure|Nonoperative Management|Watch and Wait
15803628|NCT04421157|Other|Schroth Exercises|The Schroth approach consists of 3D scoliosis-specific exercises based on kinesthetic and sensorimotor principles. The goal of Schroth exercises is to teach patients to consciously maintain the correct posture in daily living activities in order to improve the curve, pain, and self-image. The treatment program consists of scoliotic posture correction and a breathing pattern with the help of proprioceptive and exteroceptive stimulations and mirror control. Traditional exercises program included strengthening back, abdominal, pelvis and shoulder girdle muscles and also muscles in the convex side of the curve, stretching exercises especially for the concave side of the curve, postural training, flexibility exercises for the spine, and breathing exercises. Schroth group received Schroth exercises in addition to traditional rehabilitation for 10 weeks. Patients received 30 sessions for 90 minutes at the clinic for ten-week treatment period.
15803629|NCT04421157|Other|Core stabilization Exercises|Each exercise session consisted of a warm-up exercise, core stabilization exercise, and a cool-down exercise. The core stabilization exercise was designed with consideration of local, global muscle stability training, global muscle mobility training,and strengthening training of these core structures was carried out progressively advancing more difficult. Traditional exercises program included strengthening back, abdominal, pelvis and shoulder girdle muscles and also muscles in the convex side of the curve, stretching exercises especially for the concave side of the curve, postural training, flexibility exercises for the spine, and breathing exercises. The Stabilization group received Core stabilization in addition to traditional rehabilitation for 10 weeks. Patients received 30 sessions for 90 minutes at the clinic for ten-week treatment period.
15803630|NCT04421144|Procedure|orthognathic surgery|patients with maxillofacial disharmony will undergo orthognathic surgery using CAD/CAM Cutting Guides and Customized Titanium Plates.
15803631|NCT04421131|Device|Pocket colposcope/Mobile phone camera|The Pocket colposcope or mobile phone camera will be used to capture magnified digital images of the cervix
15803632|NCT04421131|Other|mIVAA|A mobile-phone-based telemedicine platform that enables remote consultation with an expert colposcopist
15803633|NCT04421118|Other|a non-invasive technology to evaluate hepatic venous pressure gradient and portal pressure gradient|a non-invasive technology to evaluate hepatic venous pressure gradient and portal pressure gradient based on three-dimensional modeling and fluid dynamics simulation
15803634|NCT04421105|Drug|Lysergic acid diethylamide (LSD) 5µg|
15803635|NCT04421105|Drug|Lysergic acid diethylamide (LSD) 10µg|
15803636|NCT04421105|Drug|Lysergic acid diethylamide (LSD)20 µg|
15803637|NCT04421105|Drug|Placebo|
15803638|NCT04421092|Procedure|Superior laryngeal nerve block|Injection of either the steroid-lidocaine mixture or placebo through the skin around where the superior laryngeal nerve is located on the neck. The procedure lasts 5 minutes and is done in the clinic.
15803639|NCT04421092|Procedure|Injection of placebo (saline)|Superior laryngeal nerve block using 1mL of saline as the injection.
15803640|NCT04421092|Procedure|Injection of steroid-lidocaine mixture|Superior laryngeal nerve block using 1mg 1:1 triamcinolone 40mg: 1% lidocaine with 1:200000 epinephrine as the injection.
15803641|NCT04421079|Dietary Supplement|Trans-resveratrol|150mg, 300mg, 450mg
15803642|NCT04421079|Dietary Supplement|Concord grape juice|8 oz, 16 oz, 24 oz
15803643|NCT04421079|Dietary Supplement|Grape seed polyphenol extract|450mg, 900mg, 1200mg
15803644|NCT04421079|Drug|Placebo|Comparable placebo supplement which is manufactured according to GMP and will contain inert substances.
15803645|NCT04421066|Procedure|Gingival and bone sample collection|Gingival and bone samples will be collected from the sites affected by peri-implantitis during their surgical treatment of peri-implantitis or histological and epigenetic analysis.
15803646|NCT04421066|Procedure|Healthy individuals|Gingival and bone samples will be collected from the extraction sites for histological and epigenetic analysis.
15803650|NCT04421027|Drug|Baricitinib|Given orally
15803651|NCT04421027|Drug|Placebo|Given orally
15803652|NCT04421014|Dietary Supplement|HVMN Ketone Esther drink|The main ingredient of HVMN Ketone Ester [(R)-3- hydroxybutyl (R)-3- hydroxybutyrate)] is regulated as GRAS (Generally Recognized as Safe) substance by the FDA (https://www.accessdata .fda.gov/ scripts/ fdcc/index.cfmset=GRASNotices&amp;id=515). The HVMN KE compound is already being sold in the market as a ketogenic supplement and is especially popular among athletes, such as cyclists (sold by the official website of the company (https://hvmn.com/ketone-ester) and in a popular selling website (https://www.amazon.com/HVMN (NotEqual)Ketone-Pocket-Sized (NotEqual)Sugar-Free (NotEqual)Performance/dp/ B07CTP3XST). The dose and formulation (25 g of KE contained in 65 ml of the drink HVMN KE), daily scheme (3 times daily) and total duration (28 days) are identical to a previous safety human study.
15803653|NCT04421014|Dietary Supplement|Placebo: isocaloric dextrose drink|The main content of the Placebo will be an aqueous solution containing ~ 35 g of dextrose. To better match the taste of the placebo to that of the HVMN KE, we will add a fruity flavor powder (provided by HVMN) and stevia. We will also add Denatonium Benzoate (Bittrex) to match the bitterness of HVMN KE. The placebo will be prepared and dispensed by the NIA Pharmacist.
15803654|NCT04421001|Device|I-port use|patient will use I-port device fo 2 months
15803655|NCT04420988|Biological|COVID-19 Convalescent Plasma|COVID-19 Convalescent Plasma from recovered COVID-19 patients transfusion into severely or life-threateningly ill COVID-19 infected patients
15803656|NCT04420975|Procedure|Definitive Surgical Resection|Undergo definitive surgical resection
15803657|NCT04420975|Drug|Immunotherapeutic Agent|Given BO-112 intratumorally
15803658|NCT04420975|Biological|Nivolumab|Given IV
15803659|NCT04420975|Radiation|Radiation Therapy|Undergo radiation therapy
15803660|NCT04420962|Diagnostic Test|Visual Acuity|Best corrected visual acuity utilizing the Snellen method
15803680|NCT04420819|Device|Ischemic Preconditioning|The IPC is characterized by the application of brief periods of circulatory occlusion (ischemia) and reperfusion of a limb in the minutes to hours that precede the exercise through the insufflations and deflations of a pressure cuff
15803661|NCT04420949|Behavioral|Sensory re-weighting|During training, sensory re-weighting is driven by priming upregulation of somatosensory cues. Two rounds of training, each lasting 15 minutes and block-randomized in sets of 10 trials, are conducted per training visit. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity. Immediate auditory and non-orienting, visual feedback is provided after each trial. A staircase method is used to adapt the level of difficulty based on response accuracy. After two consecutive correct responses, the difficulty increases. After each incorrect response, the difficulty decreases. This process is repeated in each round.
15803662|NCT04420936|Behavioral|MAINTAIN PRIME Lifestyle Coaching|Participants will receive two years patient support consisting of supportive coaching via EHR patient portal and tracking tools with EHR. Participants will also receive primary care physician (PCP) support with real time progress reports with counseling tips via EHR prior to visits, notification of weight changes greater or equal to 10 pounds, and annual PCP feedback.
15803663|NCT04420936|Behavioral|Control tracking|Participants will receive two years of patient support consisting of prevention updates via EHR patient portal and tracking tools within the EHR. Participants in this group will not receive primary care physician (PCP) support.
15803664|NCT04420923|Other|Observe and Plan|First the individual interval between the injections of anti-VEGF (vascular endothelial growth factor) is established by observing the time from the loading dose to recurrence of the disease. The patient will come to control every four weeks to establish this interval. Second, the patient will receive injections at intervals that are two weeks shorter than the observed period. 2-3 injections are given before the next control. The control should be no later than six months ahead.
15803665|NCT04420923|Other|Treat-and-Extend|"At the first control 4 weeks after the loading dose, the ophthalmologist assesses whether the macula is still wet or whether the macula is dry. In case of wet macula, the patient receives a new injection on the same day and a new control in 4 weeks. If the macula is dry, the patient will return in 2 weeks for the next injection, ie the injection interval is extended from 4 to 6 weeks.
~Patients will be controlled every time they are to receive an intravitreal injection. If the macula is dry, the injection interval will be extended by 2 weeks and if the macula is wet the interval is shortened by 2 weeks. The shortest interval will be 4 weeks."
15803666|NCT04420910|Other|Non-Motor Symptoms|NMSs of the participants were evaluated using the Non-Motor Symptoms Scale (NMSS). The scale consists of 30 yes-no questions and is administered face to face with the therapist.
15803667|NCT04420910|Other|Balance|To measure balance, the Biodex Balance System (Biodex Medical Systems, Shirley, NY, USA) was used. The participants were asked to position themselves in a comfortable position on the platform, and their foot position coordinates were recorded. The participants focused on a characteristic dot on the monitor screen. Their task was to balance the body in such a way that the dot was in the center of a circle displayed on the monitor at the point of intersection of the coordinate axes. The test consisted of three 20 s trials, each separated by 10 s breaks. Measurements were conducted while their eyes were open and close, and the results were analyzed by calculating the average value of the measurements.
15803668|NCT04420910|Other|Lower Limb Strength|A Biodex® System 4 Dynamometer device was used to evaluate muscle strength. The participants' dominant extremity was determined by asking them the foot with which they most often hit the ball.The dynamometer arm of the device was placed at the lateral condyle level of the knee, and the belt at the distal end of the dynamometer was attached to the lower leg on the malleolus. Knee flexion and extension movements were evaluated in sitting position between 90ᵒ flexion and 0ᵒ extension angles. The individual was asked to perform it with the maximum strength, while the therapist motivated the individual with verbal stimulation.
15803669|NCT04420910|Other|Functional mobility|The Timed Up and Go test (TUG) was used in the evaluation of functional mobility. . For this test, participants were seated on a standard armless chair and a cone was placed 3 meters away from the chair. Participants were instructed to stand up and (1) walk towards the cone, (2) turn around the cone, (3) walk back to the chair, and (4) sit back on the chair. It was stated that patients should walk without running but as fast as possible. Dual task performance was performed by adding cognitive and motor tasks into the TUG.
15803670|NCT04420897|Procedure|Arterial blood gas samples|Blood gases taken during the operation will be analyzed retrospectively. Whether these results have an effect on graft survival will be examined by reaching their records in the postoperative period.
15803671|NCT04420884|Drug|TAK-676|TAK-676 intravenous Infusion.
15803672|NCT04420884|Drug|Pembrolizumab|Pembrolizumab intravenous Infusion.
15803673|NCT04420871|Drug|150 mg of Xeloda®|Subjects were allocated to one of three groups randomly and equally with a 1-day wash time period. 150 mg of Xeloda® produced by Genentech USA, Inc., a subsidiary of the company, was used as the reference intervention in this study.The subjects randomly received single oral administration of 150 mg of Xeloda®.
15803674|NCT04420871|Drug|150 mg of capecitabine|Subjects were allocated to one of three groups randomly and equally with a 1-day wash time period.The tablet of 150 mg of capecitabine from Qilu Pharmaceutical Co., Ltd. (17H0053DE4, Jinan, Shandong Province, China) was used as the test formulation.The subjects randomly received single oral administration of 150 mg of capecitabine.
15803675|NCT04420858|Behavioral|Enhanced (experimental) education|See arm description.
15803676|NCT04420858|Behavioral|Standard (control) education.|See arm description.
15803677|NCT04420845|Behavioral|Diabetes Self-Management and Support (DSMES) and Sleep Hygiene Education and Support (SHES)|SHES outlines the importance of sleep for people with type 2 diabetes mellitus and provide practical information and guidance about sleep habits. Specifically, the focus will be on: avoiding consumption of caffeine, nicotine, alcohol; avoiding use of light emitting devices before bedtime; avoiding excessive intake of fluids or heavy meals before bedtime; promoting regulation of light, noise, and temperature in the bedroom; timing of and importance of exercise; maintaining consistent sleep and wake times; establishing a pre-bedtime routine; and managing stress.
15803678|NCT04420832|Procedure|Surgical treatment|Se above
15803679|NCT04420832|Other|Non-surgical treatment|See above
15803681|NCT04420806|Other|HIT-exercise|13 months of high intensity endurance and resistance exercise, 3x 45 min/week - 3 months of COVID-19 induced exercise break
15803684|NCT04420780|Dietary Supplement|Administration of sugar-free gums sugar-free gums containing 100% Xylitol as sweetener|The subjects will be instructed to chew a total of 6 pellets for 5 min divided into 3 intakes a day (2 in the morning, 2 after the midday meal and 2 in the afternoon)
15803685|NCT04420780|Dietary Supplement|Administration of sugar-free gums sugar-free gums containing containing a polyols mixture plus a low amount of Xylitol (22%)|The subjects will be instructed to chew a total of 6 pellets for 5 min divided into 3 intakes a day (2 in the morning, 2 after the midday meal and 2 in the afternoon)
15803686|NCT04420767|Device|tDCS|Individuals undergo 20min daily sessions receiving actual tDCS to the brain (to the right DLPFC: dorsolateral prefrontal cortex)
15803687|NCT04420767|Device|Sham brain stimulation|Individuals undergo 20min daily sessions receiving sham stimulation to the brain (to the right DLPFC: dorsolateral prefrontal cortex)
15803688|NCT04420767|Behavioral|Go-No GO task|During the brain stimulation sessions, all individuals will be asked to perform a 10 min-computerized task related to inhibitory control (Go-No Go)
15803689|NCT04420754|Biological|AIC100 CAR T Cells|Autologous CAR T cells directed against ICAM-1
15803690|NCT04420741|Drug|Iloprost|Continuously infusion for 72 hours at 3 ml/hours. Treatment dose 1 ng/kg/min
15803691|NCT04420741|Drug|Isotonic saline|Continuously infusion for 72 hours at 3 ml/hours
15803692|NCT04420728|Combination Product|Early auto-mode|Participant will be switched to or continue to use the MiniMed 670G insulin pump in manual mode during pregnancy. After the birth of their child, each participant will be randomized to either early auto-mode enabled MiniMed 670G or delayed auto-mode.
15803693|NCT04420728|Combination Product|Delayed auto mode|Participant will be switched to or continue to use the MiniMed 670G insulin pump in manual mode during pregnancy. After the birth of their child, each participant will be randomized to either early auto-mode enabled MiniMed 670G or delayed auto-mode.
15803694|NCT04420715|Other|Training on coronary angiography using 3D coronary artery simulator|Participants will have a test of coronary arteriography before and after training, compare the scores to analysis if the simulator training is effective.
15803695|NCT04420702|Device|MRI with DBSI analysis|-The procedure will take approximately 1 hour of the participant's time
15803696|NCT04420689|Drug|ALM-488|ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.
15803697|NCT04420676|Dietary Supplement|Omnibiotic AAD|Bacterial strains in Omni-Biotic® 10 AAD are Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Enterococcus faecium W54, Lactobacillus acidophilus W37, Lactobacillus acidophilus W55, Lactobacillus paracasei W20, Lactobacillus plantarum W1, Lactobacillus plantarum W62, Lactobacillus rhamnosus W71 and Lactobacillus salivarius W24 which are embedded in a matrix containing maize starch, maltodextrin, inulin, potassium chloride, hydrolysed rice protein, magnesium sulphate, fructooligosaccharide (FOS), enzymes (amylases), vanilla flavour and manganese sulphate
15803698|NCT04420676|Dietary Supplement|Placebo|matrix containing maize starch, maltodextrin, inulin, potassium chloride, hydrolysed rice protein, magnesium sulphate, fructooligosaccharide (FOS), enzymes (amylases), vanilla flavour and manganese sulphate.
15803699|NCT04420663|Diagnostic Test|Pleural Manometry|Recording pleural pressure during therapeutic thoracocentesis using a simple water manometer.
15803700|NCT04420650|Device|transcranial direct current stimulation|anodal or cathodal transcranial direct current stimulation
15803702|NCT04420611|Other|Session 1 (day 1)|"12 hours overnight urine (9 pm - 9 am) will be collected. First morning voids will be collected separately in order to be also analysed independently from the 12 hours collection. 24 hours before the 12 hours overnight urine collection, volunteers will be asked to refrain from alcohol consumption and methylxanthine-containing beverages and foods.
~After the 12-hour urine collection (around 9:00 a.m.), subjects will be given a cup of coffee or a can of Coca-Cola®. Capillary blood samples (10 μL) will be taken from the fingertips 2 hours after the coffee or Coca-Cola®."
15803703|NCT04420611|Other|Session 2 (day 3)|"12 hours overnight urine (9 pm - 9 am) will be collected. First morning voids will be collected separately in order to be also analysed independently from the 12 hours collection. 24 hours before the 12 hours overnight urine collection, volunteers will be asked to refrain from alcohol consumption and methylxanthine-containing beverages and foods.
~After the 12-hour urine collection (around 9:00 a.m.), subjects will be given a cup of coffee or a can of Coca-Cola®. Capillary blood samples (10 μL) will be taken from the fingertips 2 hours after the coffee or Coca-Cola®."
15803704|NCT04420611|Other|Session 3 (day 15)|"12 hours overnight urine (9 pm - 9 am) will be collected. First morning voids will be collected separately in order to be also analysed independently from the 12 hours collection. 24 hours before the 12 hours overnight urine collection, volunteers will be asked to drink or eat caffeinated food/drinks 24 hours prior to night-time urine collection (at least one cup of coffee or a can of Coca-Cola®).
~After the 12-hour urine collection (around 9:00 a.m.), subjects will be given a cup of coffee or a can of Coca-Cola®. Capillary blood samples (10 μL) will be taken from the fingertips 2 hours after the coffee or Coca-Cola®."
15803705|NCT04420611|Other|Session 4 (day 30)|"12 hours overnight urine (9 pm - 9 am) will be collected. First morning voids will be collected separately in order to be also analysed independently from the 12 hours collection. 24 hours before the 12 hours overnight urine collection, volunteers will be asked to refrain from alcohol consumption and methylxanthine-containing beverages and foods.
~After the 12-hour urine collection (around 9:00 a.m.), subjects will be given a cup of coffee or a can of Coca-Cola®. Capillary blood samples (10 μL) will be taken from the fingertips 2 hours after the coffee or Coca-Cola®."
15803706|NCT04420598|Drug|Trastuzumab deruxtecan|"After having confirmed eligibility and entered into the clinical trial, patients will be treated with trastuzumab deruxtecan (DS-8201a) at 5.4 mg/Kg administered as an intravenous (IV) infusion on Day of 21-day cycle (Q3W), initially for at least 90 minutes, then, if there is no infusion-related reaction, for a minimum of 30 minutes.
~In patients with hormone receptor (HR)-positive status (estrogen receptor [ER] and/or progesterone receptor [PgR]) administration of endocrine therapy is not allowed.
~In patients allocated in study cohort 5, administration of intrathecal therapy is not allowe"
15803707|NCT04420585|Drug|Desmopressin|Two desmopressin 0.2 mg tablets at bedtime for 14 days and monitoring if <50 % improvement
15803770|NCT04419987|Genetic|draw blood|search for new genetic variations (when the diagnostic exploration will have been non informative) by sequencing exons.
15803710|NCT04420559|Other|Intramuscular Injection|Intramuscular Benzathine Penicillin Injection Procedure
15803711|NCT04420546|Behavioral|Volitional help sheet|Participants are asked to choose from a list of strategies for increasing physical activity
15803712|NCT04420546|Behavioral|Volitional help sheet|Participants are asked to choose from a list of strategies for avoiding self-harm
15803713|NCT04420533|Behavioral|Behavior therapy alone|"reduction of fluid intake at specific times aimed at reducing urinary frequency when most inconvenient;
~moderation of intake of caffeine or alcohol, which may have a diuretic and irritant effect, thereby increasing fluid output and enhancing frequency, urgency and nocturia;
~use of relaxed and double-voiding techniques;
~urethral milking to prevent post-micturition dribble;
~distraction techniques such as penile squeeze, breathing exercises, perineal pressure, and mental tricks to take the mind off the bladder and toilet, to help control storage symptoms;
~bladder retraining that encourages men to hold on when they have sensory urgency;
~reviewing the medication and optimising the time of administration or substituting drugs for others that have fewer urinary effects (these recommendations apply especially to diuretics);
~providing necessary assistance when there is impairment of dexterity, mobility or mental state;
~treatment of constipation."
15803714|NCT04420533|Drug|Mirabegron 50 MG Extended Release Oral Tablet|Betmiga prolonged-release tablets (mirabegron) 50mg QDAC PO
15803715|NCT04420494|Other|Umbilical Cord Blood|The diagnosis is definitely immune cytopenia (IRC), including autoimmune hemolytic anemia (AIHA, Hgb <100g / L, acquired pure red aplastic anemia (PRCA, Hgb <100g / L, EVANS syndrome , Hgb <100g / L and / or platelet count <30 × 109 / L, or blood cell reduction secondary to immune diseases (the same as the treatment indications, or neutrophils <0.5 × 109 / L), at least after hormone therapy Patients who are ineffective (did not reach PR after 4 weeks of hormone therapy) or who have not achieved PR after 3-5 mg / kg / d of cyclosporine. These patients would be treated with umbilical cord blood.
15803716|NCT04420481|Drug|Somatropin|Dose: 1,4 mg (4,2 IE) every other day Dosage: 9 month treatment period and a 3 month follow-up period Administration: One subcutaneous injection of somatropin or corresponding placebo in the thigh or abdomen given in the evening given every other day.
15803717|NCT04420481|Drug|Placebo|Placebo
15803718|NCT04420455|Drug|Enoximone|Patients will receive three times a dose of 0.5 mg/kg enoximone with a one-hour-interval.
15803719|NCT04420442|Procedure|Scar Transformation Group|Surgical excision of the NSSI scars followed by IntegraTM transplantation and wound closure with a negative pressure wound system. After 21 days the silicone layer of the IntegraTM will be removed and split thickness skin will be transplanted. After suture removal a compression therapy by individually tailored garments will be started for 12 months.
15803720|NCT04420429|Procedure|Descemet membrane endothelial keratoplasty (DMEK)|All participants underwent DMEK surgery
15803721|NCT04420416|Other|Survey|The investigators will use the Spanish language validated version of the Academic Self-Concept Scale (ASCS), the Patient Health Questionnaire-9 (PHQ-9) depression screening scale, and the General Anxiety Disorder-7 (GAD-7) screening scale. Additionally, the sample will be asked about their gender, age, preference of teaching modality, and finally, if the participants have perceived a change in their performance or any change in their grades.
15803722|NCT04420403|Other|Manual Therapy|Cyriax's mobilization techniques will be applied as manual therapy. Before the mobilization, soft tissue mobilization techniques will be applied to relieve muscular spasm and preventing the patient' s anxiety. Bringing, manual traction, manual traction with rotation, manual traction with anterior-posterior gliding and lateral gliding mobilization techniques will be applied. Appropriate mobility techniques will be selected according to the complaints and symptoms of the patients. Cervical mobilization applications will take an average of 15-20 minutes.
15803723|NCT04420403|Other|Cervical Stabilazation Exercise (CSE)|The CSE program aims to maintain a neutral spine position and activate deep cervical muscles during exercises. It is performed in stages with gradual progression according to the stages of motor learning and sensory-motor integration, namely, static, dynamic, and functional. The program will start with postural training and then the cervical bracing technique with the activation of deep neck flexors for CSE was performed. The patients will be asked to maintain a neutral spine during the exercises and throughout the day as much as possible. The difficulty and variety of exercises will be increased weekly. It will be carried out 2 days a week for 6 weeks (12 sessions) by the supervisor physiotherapist.
15803724|NCT04420390|Radiation|Radiotherapy|Low-dose radiotherapy
15803725|NCT04420377|Dietary Supplement|Carnipure|Supplement contains L-carnitine tartrate.
15803726|NCT04420377|Other|Resistance Training|5 weeks of whole-body resistance training, performed 2 times per week.
15803727|NCT04420364|Other|Maintenance or reduction of immunosuppression|Maintenance versus reduction of immunosuppression
15803728|NCT04420351|Drug|Urokinase thrombolysis|The patients of intervention group will receive 1 millions units urokinase dissolved by 100 saline through intravenous infusion within 30 minutes.
15803729|NCT04420351|Drug|Aspirin;Clopidogrel|The control group will receive antiplatelet agents as decided by the physicians according to Chinese guideline for diagnosis and treatment of acute ischemic stroke 2018.
15803730|NCT04420338|Biological|Blood sample|rapid serological tests carried out
15803731|NCT04420338|Biological|Serum tube collection|SARS-COV2 seroconversion assay
15803732|NCT04420299|Drug|Bemiparin|Bemiparin at therapeutic dose for 10 days
15803733|NCT04420299|Drug|Bemiparin|Bemiparin at prophylactic dose for 10 days
15803734|NCT04420273|Behavioral|SSE educational intervention|Women participants receive a SSE brochure and three monthly reminders to perform SSE. In the second month, women select goals for SSE.
15803766|NCT04420039|Device|Endoscopic biliary transmural drainage|"Endosonography-guided biliodigestive anastomosis using a dedicated biliary lumen-apposing stent in order to proveide a biliary drainage in cases of palliative malignant biliary obstruction.
~Two different strategies will be compared: single lumen-apposing stent vs lumen-apposing stent plus dousble-pigtail plastic stent."
15803767|NCT04420026|Radiation|Interact Active Tracker|Interact Active Tracker, allowing the automation of the fusion between a CBCT and ultrasound imaging
15803735|NCT04420273|Other|Home sample collection of concerning mole with physician supervision|The participant will be given directions about taking a picture of the concerning mole. The picture will be reviewed by the physician, who determines if the pigmented lesion is concerning and sends an adhesive patch skin sample collection kit to the participant. The participant will receive directions about obtaining the sample, and returning it to the processing laboratory. The physician will obtain the results of the genomic analysis and provide them to the participant. If the analysis suggests that the concerning mole may be a melanoma, then the woman will be advised to have the mole biopsied and a referral will be provided.
15803736|NCT04420273|Behavioral|Active control:Healthy Living|Women participants receive a Healthy Living brochure and three monthly reminders to perform the following activities of healthy living: get quality sleep, walk briskly for 30 min, eat 5 servings of fruits and vegetables a day. In the second month, women select goals for healthy living.
15803737|NCT04420260|Dietary Supplement|Group A: oropharygeal spray and immunostimulant emulsion|"Intervention 1: Preparation in a liquid solution to be used for oropharyngeal spray, composed of 3 natural bioactive substances of routine use in humans, that feature homologous molecular structures to the native viral receptor.
~Intervention 2. Preparation in an emulsion functional food presentation for oral administration, that contains the 8 bioactive compounds that have demonstrated antiviral activity and modulation of the inflammatory response recognized at the moment in the immune activation against the virus."
15803738|NCT04420260|Dietary Supplement|Group D:Placebo oropharyngeal spray + Placebo taken PO|"Intervention 1: Preparation in a liquid solution to be used for oropharyngeal spray, composed of Placebo substances of routine use in humans.
~Intervention 2. Preparation in an emulsion presentation for oral administration that contains the Placebo compounds"
15803739|NCT04420247|Drug|Chloroquine|5 days of treatment with Chloroquine + Standard Care
15803740|NCT04420247|Drug|Hydroxychloroquine|5 days of treatment with Hydroxychloroquine + Standard Care
15803741|NCT04420247|Other|standard care|Standard Care according to Brazilian Guidelines for treating COVID-19
15803742|NCT04420234|Drug|narfurine hydrochloride orally disintegrating tablets|Subjects swallowed 2 tablets of test drug (2.5 µg/tablet) with saliva at about 8:00 AM on D1; swallowed 2 tablets of test drug (2.5 µg/tablet) with saliva at about 8:00 AM starting on D4. Dosing for 7 consecutive days (D10 last dose in the morning).
15803749|NCT04420195|Drug|Extended-Release Tacrolimus|Envarsus XR is an FDA-approved drug for the prophylaxis of organ rejection in de novo kidney transplant patients or in kidney transplant patients converted from IR tacrolimus when used with other immunosuppressants. Envarsus XR is a novel extended-release formulation of tacrolimus created using MeltDose technology. Envarsus XR is available in tablet form. It is available in 0.75, 1, and 4 mg tablets.
15803750|NCT04420195|Drug|Immediate-Release Tacrolimus|Historical cohort of 20 subjects who will be maintained on IR tacrolimus following transplant. Dosing will be converted on an individual basis (Capsules: 0.5 mg, 1 mg and 5 mg or Injection: 5 mg) . All patients will be initiated on IR tacrolimus either under the tongue (sublingual) or as a solution given through a tube placed through the nose into the stomach, which is standard of care for all lung transplant recipients.
15803751|NCT04420182|Other|Virtual Care at Home|Participants will have access to the VIRTUES platform for COVID-19 Virtual Care at Home
15803752|NCT04420169|Other|Questionnaire|A digital questionnaire to evaluate the communication by midwives will be send out to IVF patients
15803753|NCT04420156|Other|No intervention administered.|Eye exams are standard of care and would be performed regardless of participation in this study.
15803754|NCT04420130|Drug|Camrelizumab|Camrelizumab was administered 200mg iv every 3 weeks
15803755|NCT04420130|Drug|Chemotherapy|The chemotherapy regimen may be a standard regimen for routine treatment of advanced pancreatic cancer.
15803756|NCT04420130|Procedure|Ablation|First give pancreatic cancer patients with liver metastases to ablation of liver metastases
15803757|NCT04420117|Other|Perioperative assessment of physical capacity|Evaluation of physical capacity with the Short Physical Performance Battery (SPPB) questionaire
15803758|NCT04420104|Procedure|erector spinae plane block|ESP Block: Bilateral ESP block and with ultrasound guidance will be applied A total 40 ml, 20 ml bupivacaine 0.5%, 20 ml saline.
15803759|NCT04420104|Drug|iv analgesia|iv contromal
15803760|NCT04420091|Dietary Supplement|Cartidyss|Oral intake of two tablets of Cartidyss 500 mg, once daily in the morning, preferably during a meal, with water, during 3 months
15803761|NCT04420078|Procedure|Catheter Ablation|Ventricular fibrillation substrate
15803762|NCT04420065|Device|Preferential left ventricular pacing|Activation of an algorithm attempting to provide preferential left ventricular pacing in an anticipatory manner, thus potentially preventing iatrogenic, pacing-related, right ventricular dysfunction, and improving coupling and outcomes in dyssynchronous heart failure patients
15803763|NCT04420065|Device|Biventricular pacing|Standard biventricular pacing, with V-V delay programmed based on stroke volume maximization, and A-V delay delegated to the device
15803764|NCT04420052|Other|Osteopathic manipulative treatment|"Osteopaths will executed several high velocity low amplitude (HVLA) techniques on the upper thoracic spine and cervical spine. These techniques are assumed to modulate the sympathetic cervical ganglia and reduce inflammation in chronic rhinosinusitis.
~This procedure takes around 15 minutes."
15803765|NCT04420052|Other|Placebo manipulation|"The osteopath will lay hands without movement on the nose, the throat and the thorax of patients.
~This procedure takes around 15 minutes."
15803771|NCT04419974|Diagnostic Test|Molecular Diagnosis|Double-blind molecular diagnosis for the SCA3/MJD mutation.
15803772|NCT04419974|Diagnostic Test|Clinical Scales - Baseline|SARA, NESSCA, ICARS, INAS, SCAFI, CCFS will be applied on baseline.
15803773|NCT04419974|Diagnostic Test|Blood Draw - Baseline|"Blood collection on baseline for evaluation of
~Candidate genes expression
~Serum proteins
~Lymphocytic proteins"
15803774|NCT04419974|Diagnostic Test|Quality of Life Assessment - Baseline|Participants fill out 2 self-reported quality of life questionnaires.
15803775|NCT04419974|Diagnostic Test|Clinical Scales - Follow-up 12 months|SARA, NESSCA, ICARS, INAS, SCAFI, CCFS will be applied 12 months after baseline for prospective evaluation.
15803776|NCT04419974|Diagnostic Test|Blood Draw - Follow-up 12 months|"Blood collection 12 months after baseline for prospective evaluation of
~Candidate genes expression
~Serum proteins
~Lymphocytic proteins"
15803777|NCT04419974|Diagnostic Test|Quality of Life Assessment - Follow-up 12 months|Participants fill out 2 self-reported quality of life questionnaires for prospective evaluation.
15803778|NCT04419974|Diagnostic Test|Clinical Scales - Follow-up 24 months|SARA, NESSCA, ICARS, INAS, SCAFI, CCFS will be applied 24 months after baseline for prospective evaluation.
15803779|NCT04419974|Diagnostic Test|Blood Draw - Follow-up 24 months|"Blood collection 24 months after baseline for prospective evaluation of
~Candidate genes expression
~Serum proteins
~Lymphocytic proteins"
15803780|NCT04419974|Diagnostic Test|Quality of Life Assessment - Follow-up 24 months|Participants fill out 2 self-reported quality of life questionnaires for prospective evaluation.
15803781|NCT04419961|Behavioral|Educational program|"The educational program includes a group discussion and a booklet.
~The group discussion lasts for 90 minutes, discussing importance of sexual activity during pregnancy, improving sexual experience during pregnancy, physical and mental changes of pregnant women, and measures to cope with discomfort, anxiety, fear and other issues. It includes a 30-minutes presentation, followed by 1-hour discussion.
~The booklet is a color-printed A5-size booklet containing in-depth information of the content given during the discussion. Each participant can only receive one copy of the booklet, and the booklet is not given to the control participants."
15803782|NCT04419948|Other|White bread|White bread (120g) containing 54 g CHO
15803783|NCT04419948|Other|Butter|Butter 39 g
15803784|NCT04419948|Other|Refined olive oil|Refined olive oil (40 ml).
15803785|NCT04419948|Other|EVOO with 250 mg/kg oleocanthal|Extra virgin olive oil containing 250 mg/kg oleocanthal.
15803786|NCT04419948|Other|EVOO with 500 mg/kg oleocanthal|Extra virgin olive oil containing 500 mg/kg oleocanthal.
15803787|NCT04419948|Other|Ibuprofen|Ibuprofen 400 mg
15803788|NCT04419935|Procedure|lymphadenectomy|Lymphadenctomy according with ESTS guidelines
15803789|NCT04419922|Behavioral|Smartphone Contingency Management Intervention|Participants will provide baseline data on their recent substance use and smoking habits/severity. Participants will 1) download the DynamiCare Rewards app, and 2) receive a Carbon Monoxide breath testing device (iCO™ Smokerlyzer®) and reloadable debit card for receiving financial incentives. Participants will follow instructions on the app to take breath tests and receive incentives if the carbon monoxide breath result is less than 6 ppm (Cessation mode) or lower than 3 of the last 4 tests (Shaping mode). The app will use GPS to track if patients have attended their scheduled BrightView appointments (GPS is not used at any other time) and reward them for all kept appointments. The participant will also be able to view Cognitive Behavioral Therapy (CBT) modules on the app and receive incentives upon completing each module. At all times, the participant retains the right to choose whether to use and when to use the app, device, and funds for a total period of 4 months.
15803790|NCT04419909|Drug|CD19 redirected autologous T cells (CTL019 or CTL119 cells)|Retreatment with CD19-directed Chimeric Antigen Receptor-modified T Cells (CART19 cells) or huCD19-directed Chimeric Antigen Receptor-modified T Cells (huCART19 cells) in subjects with late relapse of B-cell lymphomas.
15803791|NCT04419883|Device|McMurray Enhanced Airway|Provider Satisfaction of a New, Flexible Extended-Length Pharyngeal Airway to Relieve Upper Airway Obstructive During Deep Sedation: A Pilot Study
15803792|NCT04419857|Dietary Supplement|High-calorie formula|Infant randomly assigned to high-calorie formula for 14 days
15803793|NCT04419844|Procedure|Tar with Botox|Evaluation of TAR technique in the treatment of huge abdominal wall hernia and large abdominal wall defect with Botox injection .
15803794|NCT04419831|Behavioral|Cold Pressor Task|Cold Pressor Task
15803795|NCT04419818|Behavioral|Virtual Reality|Virtual Reality task consists of a 3D computer-generated virtual environment that will be displayed on a desktop VR computer monitor. A joystick will provide the graphical interface for patients by allowing user-friendly exploration of virtual scenarios. Participants will be presented 16 actions, with dynamic simulations of real life situations. They will verbally estimate and reproduce the duration of each previously presented action.
15803796|NCT04419805|Device|Single Palatal TAD|A single mini-screw inserted in the mid-palate
15803797|NCT04419805|Device|Two buccal TADs|Two buccal TADs inserted in the upper jaw
15803798|NCT04419792|Other|Assessment of physical performance variables|"Other:
~Assessment of physical performance indices using the following outcome measures:
~Cardiopulmonary fitness: YMCA submaximal bike test Upper Body: ACSM press up test, Dynamometry Lower body: Wall squat test, Countermovement jump test"
15803799|NCT04419779|Device|Duodenal Mucosal Resurfacing (DMR)|The Fractyl DMR Procedure utilizes the Revita® Catheter to perform hydrothermal ablation of the duodenum. The Catheter is delivered trans-orally over a guide-wire to first inject saline to lift the sub-musical space, followed by an ablation of the duodenal mucosa. Subjects who receive the DMR treatment are followed for 48 weeks post treatment.
15803800|NCT04419779|Device|Duodenal Mucosal Resurfacing (Sham)|The Sham procedure consists of placing the Revita® Catheter as described above into the duodenum for a minimum of 30 minutes and then removing it from the patient. Subjects who receive the Sham procedure are followed for 48 weeks post treatment and are offered cross over to undergo the DMR procedure at 48 weeks and are followed for further 24 weeks post treatment. Sham subjects who choose not to cross over are discontinued from the study.
15803801|NCT04419766|Other|IR3535 (3-(N-acetyl-N-butyl) aminopropionic acid ethyl ester) house spraying|The spraying will be performed monthly during the first 3 months, bimonthly during the next 6 months and then quarterly thereafter. The spraying will be carried out inside and outside the houses during the morning.
15803871|NCT04419181|Drug|Trastuzumab emtansine|Dose: 3.6mg/kg q3w
15803802|NCT04419753|Behavioral|attention focus walking training|Use different attention focus instructions or no attention focus instruction during walking training in older adults to examine whether the attention focus instructions can ameliorate conscious motor processing and optimize rehabilitation outcome measurements.
15803803|NCT04419740|Behavioral|Mindfulness based psychological intervention|Women in the intervention group will have to use an application during 1 month. They will do meditation during 15 minutes each day.
15803804|NCT04419727|Procedure|arterial reconstructive open surgery|Patients with peripheral artery disease (PAD) will undergo arterial reconstructive open surgery. Samples obtained from diseased arteries of lower limbs of patients undergoing arterial reconstructive open surgery will be collected and immediately preserved at -80°. Briefly, the arterial tissues will be excised, homogenized with a motor-driven homogenizer and total RNA will be isolated using Trizol reagent (Invitrogen, Milan Italy), according to the manufacturer's instructions. The expression of ER-alpha, ER-beta,and GPER will be quantified by real-time PCR using the Step One ™ sequence detection system (Applied Biosystems Inc. Milan, Italy), following the manufacturer's instruction
15803805|NCT04419701|Procedure|periarticular infiltration|"The cocktail will be injected at the following 7 anatomical zones as follows:
~Zone 1: medial retinaculum Zone 2: medial collateral ligament and medial meniscus capsular attachment Zone 3: posterior capsule Zone 4: lateral collateral ligament and lateral meniscus capsular attachment Zone 5: lateral retinaculum Zone 6: patellar tendon and fat pad Zone 7: cut ends of quadriceps muscle and tendon Injection at zones 2, 3, and 4 will be administered after making the tibial and femoral cuts and ligament balancing. At zones 1, 5, 6, and 7, the injection will be administered after implant placement."
15803806|NCT04419701|Procedure|genicular nerve block|The genicular arteries will be identified near the periosteal areas, which are the junctions of the epicondyle and the shafts of the femur and tibia, and confirmed by color Doppler ultrasound. genicular nerve block target points should be next to each genicular artery because the superior lateral, superior medial, and inferior medial genicular artery traveled along each genicular nerve.After using color Doppler to confirm the genicular artery, the needle will be inserted in the plane of the ultrasound probe in the long-axis view.
15803807|NCT04419688|Drug|STT-5058|Monoclonal Antibody STT-5058
15803808|NCT04419688|Drug|Placebo|Matching placebo to STT-5058
15803809|NCT04419675|Other|Observational Cohort, usual care = physical therapy|usual care = physical therapy
15803810|NCT04419662|Drug|Phenylephrine|"Three time points: before, during and 20-30 minutes after infusion of phenylephrine.
~Patients will receive an infusion of up to 1 mcg/kg/min phenylephrine intravenously to raise mean arterial pressure with 20 mmHg for 10 minutes. Infusion of phenylephrine will start at 0.1 mcg/kg/min with subsequent titration to effect."
15803811|NCT04419662|Other|Combination of PEEP and positioning|"Six time points based on combinations of the following:
~Three different levels of PEEP (as set on the ventilator): 0, 6 and 12 mmHg. Two different positions: 1) torso elevated 30 degrees, legs horizontal and 2) torso horizontal, legs elevated 30 degrees."
15803812|NCT04419649|Drug|KER-050|KER-050 administered (SC) every 4 weeks for up to 4 cycles
15803813|NCT04419636|Drug|Lu AG06466|capsules, orally
15803814|NCT04419623|Drug|TL-895|TL-895, administered by mouth
15803815|NCT04419610|Biological|TRV027|peptide for infusion
15803816|NCT04419610|Other|sodium chloride 0.9%|placebo comparator for infusion
15803817|NCT04419597|Device|HEMOPATCH|The treatment will be performed with the HEMOPATCH collagen patch and hemostatic PEG sealant (Baxter), applying two units of the large patch to reinforce the primary dural closure (HEMOPATCH 4.5x9cm, 1506253).
15803818|NCT04419597|Device|Standard of care|Usual clinical practice techniques for reinforcing primary dural closure.
15803819|NCT04419584|Drug|Modified Qing-Ying Decoction|Herbal granules
15803820|NCT04419584|Drug|Identical looking placebo|Placebo granules
15803821|NCT04419571|Procedure|Emergency Laparotomy|All adult patients undergoing emergency laparotomy
15803822|NCT04419558|Drug|Pamrevlumab|Sterile solution for injection
15803823|NCT04419558|Drug|Placebo|Sterile solution for injection
15803824|NCT04419545|Diagnostic Test|Neural network diagnosis algorithm|we feed neural network with chest x-ray radiography images for teaching the network for automatic diagnosis of interstitial pneumonia
15803825|NCT04419532|Drug|DS-1055a|"Administered as an intravenous infusion on Day 1 of every 21-day cycle.
~Infusion duration: 180 minutes for the first infusion, and if no infusion-related reaction, 120 minutes for subsequent infusions"
15803826|NCT04419519|Drug|Venetoclax monotherapy|Venetoclax monotherapy
15803827|NCT04419519|Drug|Venetoclax with anti CD20 monoclonal antibody|Venetoclax with anti CD20 monoclonal antibody
15803828|NCT04419506|Drug|BI 1015550|film-coated tablet
15803829|NCT04419506|Drug|Placebo|film-coated tablet
15803830|NCT04419493|Drug|Alteplase (from modified manufacturing process)|Alteplase
15803831|NCT04419493|Drug|Alteplase (from current manufacturing process)|Alteplase
15803832|NCT04419493|Drug|Heparin-Natrium-5000-ratiopharm (unifractionated heparin)|Heparin-Natrium-5000-ratiopharm (unifractionated heparin)
15803833|NCT04419480|Device|CardioMEMS implantation with routine ambulatory pulmonary artery pressure monitoring and medication optimization|Implantation of CardioMEMS Device in patients following admission for Cardiogenic shock, with regular ambulatory pulmonary artery pressure monitoring and medication optimization for the treatment of heart failure.
15803834|NCT04419467|Biological|CSL346|VEGF-B antagonist monoclonal antibody
15803835|NCT04419467|Drug|Placebo|Normal saline
15803836|NCT04419454|Device|BodyTite|retrospectively evaluate this novel treatment approach to improve the appearance of cellulite on the thighs and buttocks by tightening the SFS using RFAL.
15803837|NCT04419441|Drug|Immune checkpoint inhibitor|concomitant administration of radiotherapy and immune checkpoint inhibitor
15803838|NCT04419428|Device|BiPAP A40 Expiratory Flow Limitation (EFL)|All participants in the observational registry will be using the BiPAP A40 EFL noninvasive ventilator as part of standard of care and will be participating in the same follows up and data collection. The BiPAP A-40 EFL ventilator is intended to provide non-invasive ventilatory support to treat adult patients with Respiratory Insufficiency with the primary cause being COPD. It is intended to be used within the home, institution/hospital, and diagnostic laboratory environments.
15803872|NCT04419168|Other|cCBT|A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both cCBT.
15803839|NCT04419415|Dietary Supplement|Breakfast with high protein dairy|High protein yoghurt containing approx. 10 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) for breakfast.
15803840|NCT04419415|Other|Exercise training|Participants will be asked to participate in organized exercise training 3 times per week.
15803841|NCT04419415|Other|Skipping breakfast|Participants will be asked to skip breakfast.
15803842|NCT04419402|Drug|Lu-PSMA|"Patients will be given 7.5 GBq of Lu-PSMA in 4 doses. Dose 1 and 2 on Days 15 and 57. Doses 3 and 4 (Days 113 and 169) will be given following result of 68Ga-PSMA PET/CT at Day 92.
~Treatment administered every 6 weeks, x 4 cycles."
15803843|NCT04419402|Drug|Enzalutamide|160 mg (four 40 mg capsules) daily.
15803844|NCT04419389|Drug|APR-246 (eprenetapopt) + Acalabrutinib in CLL|APR-246 D1, 8 and 15 of each cycle Acalabrutinib will be given at a standard dose and schedule
15803845|NCT04419389|Drug|APR-246 (eprenetapopt) + Venetoclax + Rituximab in CLL|APR-246 D1, 8 and 15 of each cycle Venetoclax + Rituximab will be given at a standard dose and schedule
15803846|NCT04419389|Drug|APR-246 (eprenetapopt) + (Acalabrutinib, OR, (Venetoclax +Rituximab)), in CLL and/or MCL and/or RT|APR-246 D1, 8 and 15 of each cycle Acalabrutinib will be given at a standard dose and schedule Venetoclax and Rituxiab will be given at a standard dose and schedule
15803847|NCT04419389|Drug|APR-246 (eprenetapopt) + Venetoclax + Rituximab in RT|APR-246 D1, 8 and 15 of each cycle Venetoclax + Rituximab will be given at a standard dose and schedule
15803848|NCT04419376|Device|driving pressure|Mechanically ventilated patients (via ETT or trachestomy) were recorded for patients whose ventilation duration lasted at least 24 hours.We divided the patients into two groups by calculating the oxygenation index (OI): [mean airway pressure(MAP) × fraction of inspired oxygen (FiO2) ]/ partial pressure of oxygen in arterial blood (PaO2) × 100) used in the classification of PALICC, including pARDS and non-pARDS.
15803849|NCT04419363|Drug|Burosumab Injection|Children affected with X-linked hypophosphatemia were switched from conventional therapy to burosumab
15803850|NCT04419350|Procedure|Microneedling|One session of microneedling will be performed by using dermaroller 1.5 mm. The microneedling done from the edge of the normal skin towards the center of the hypopigmented lesion in all the directions (horizontal, vertical. diagonal).
15803851|NCT04419337|Drug|Metformin plus Pioglitazone plus an SGLT2 inhibitor|Patients assigned to active group will stop their prior oral antidiabetic drugs and receive combination of metformin, pioglitazone, and an SGLT2 inhibitor (empagliflozin or dapagliflozin or canagliflozin) and dose will be adjusted by their physicians.
15803852|NCT04419324|Device|transoral flexible endoscope with magnifying narrow band imaging|To use an esophago-gastroscopy endoscope (OGD) with Narrow Band Imaging (NBI) passed transorally and retroflexed into the nasopharynx to view the nasopharynx with increased magnification and clarity for the diagnosis of nasopharyngeal carcinoma.
15803853|NCT04419311|Device|Vanguard® Knee System|Posterior cruciate ligament retention versus sacrificing is one of the main debates in total knee arthroplasty (TKA) and retention or sacrificing depends on the individual preference of the surgeon during the surgery. Whenever the surgeon decides to sacrifice the posterior cruciate ligament (PCL), another controversial question arises regarding the tibial insert type. While the posterior cruciate ligament-stabilized (PS) insert is widely used as the tibial insert in PCL-sacrificing TKA, it has some disadvantages such as increased polyethylene wear, additional bone resection, breakage of the post and patellar clunk syndrome. The ultra-congruent (UC) insert was designed to prevent bone loss in particular, and the other mentioned disadvantages of the conventional PS insert. However, patients with postoperative hyperextension have been seen to be associated with inferior clinical outcomes and knees become gradually more extended until two years after TKA using the UC insert.
15803854|NCT04419298|Diagnostic Test|Cardiac MRI|"Cardiac MRI be taken to acute CO poisoned patients with elevated TnI [during acute (within 7 days after CO exposure) and chronic phase (at 4-5 months after CO exposure)]
~TTE be taken to acute CO poisoned patients with elevated TnI [At the ED and during admission (within 7 days after CO exposure)]"
15803855|NCT04419285|Behavioral|Locomotion task|The locomotion task takes place on a Streetlab platform. The subject must follow a line on the ground, straight or composed of turns.
15803856|NCT04419285|Behavioral|Posturology task SOT (Sensory Organization Test)|The task takes place on a Streetlab platform with uniform walls without decorations in order to remove any localization element.
15803857|NCT04419285|Behavioral|The quality of life questionnaire|Study the correlations between the subjects' quality of life scores and the results during behavioral tests. Identify the subjective parameters most sensitive to sensory-motor performance.
15803858|NCT04419272|Drug|Methylphenidate|10mg twice per day, at 8am and 12pm, for one week, then increased to 20mg twice daily, at 8am and 12pm, for the next 3 weeks during the double-blinded period. During the open-label extension phase, dosing will begin at 10mg twice per day, at 8am and 12pm, for one week. The dosage will then increase to 20mg twice daily, at 8am and 12pm, for the next 7 weeks.
15803859|NCT04419272|Other|Placebo|When assigned to receive the placebo during the double-blinded period, subjects will be given a sugar pill for 4 weeks. The sugar pill will be taken twice per day, at 8am and 12pm.
15803860|NCT04419259|Drug|AMG 334|30 subjects with rosacea will be allocated to receive monthly subcutaneous injections of 140 mg erenumab at three time points (week 0, week 4, week 8)
15803861|NCT04419246|Other|interscalene block|ultrasound guided ultrasound guided interscalene block 30 minutes before operation. 30 minutes before operation.
15803862|NCT04419246|Drug|tranexamic acid|10 mg/kg intravenous tranexamic acid 10 minutes before the incision.
15803863|NCT04419246|Other|general anesthesia|general anesthesia will be applied in accordance with standard procedures
15803864|NCT04419233|Drug|Nusinersen Sodium Injection|Administered as specified in the treatment arm.
15803865|NCT04419220|Other|Doppler Ultrasound|Flow measurements using Doppler ultrasound
15803866|NCT04419207|Diagnostic Test|Breath test|Exhaled breath of each participant will be collected with air bags and directly detected by a high-resolution high-pressure photon ionization time-of-ﬂight mass spectrometry (HPPI-TOFMS).
15803867|NCT04419181|Drug|Docetaxel|Dose: 75 mg/m2 q3w
15803868|NCT04419181|Drug|Carboplatin|Dose: area under the concentration-time curve [AUC] 6 q3w
15803869|NCT04419181|Drug|Trastuzumab|Dose: 8-mg/kg loading dose, 6-mg/kg maintenance dose q3w
15803870|NCT04419181|Drug|Pertuzumab|Dose: 840-mg loading dose, 420-mg maintenance dose q3w
15803873|NCT04419168|Other|m-Education|A digital, internet-delivered, evidence-based chatbot programmed to deliver content for both m-Education.
15803874|NCT04419142|Procedure|Total infrapatellar fat pad excision|Exposure for total knee arthroplasty (TKA) commonly includes total excision of the infrapatellar fat pad (IPFP). The rationale behind this is to obtain improved access to the lateral tibial plateau allowing a more accurate bone cut, baseplate placement and easier management of soft tissue interposition in the bone and cement interface. However, there is growing concern that as the IPFP is a highly vascularized and innervated fibrous adipose tissue filling the anterior compartment of the knee, its complete excision may have a detrimental effect on knee biomechanics and ultimately, TKA outcome. The reason for this effect has been suggested to be patellar tendon (PT) scarring and shortening via ischemic contracture following impaired vascularization, maintenance and biological repair of the tendon.
15803875|NCT04419142|Procedure|Partial infrapatellar fat pad excision|It has been suggested in the literature that partial infrapatellar fat pad excision instead of total excision would diminish the potential negative effect on patellar tendon and knee biomechanics. However, there is only limited data in the literature and choice of total/partial infrapatellar fat pad excision in TKA remains debatable.
15803876|NCT04419129|Device|Oxford UKA|knee arthroplasty
15803877|NCT04419129|Device|Vanguard TKA|knee arthroplasty
15803878|NCT04419116|Procedure|tibial preservation bone cut|tibial preservation bone cut: removing of proximal tibial less than conventional tibial bone cut with 2mm.
15803879|NCT04419103|Other|no intervention|Natural exposure of iodine.
15803880|NCT04419090|Other|web-based centralized service and message|Perform three cycles of cascade screening through several generation of family members of an index case. The contact of relatives will be initiated by the index case and supported by a web-based centralized service. The index case will be provided with a prepared email or Whatsapp message that the index case can further forward to his first-degree relatives. The email/message will contain a link to a secured web application with a code for the connection. By clicking on the link, the relative will connect to a specifically designed app. The app will provide information about the transmission mode of FH, the cardiovascular risk associated with FH and the way how to reduce this risk. The relative can then fill out information and provide agreement to be contacted for the study. The nearest specialized clinic will then contact the relative to organize further screening with similar processes.
15803881|NCT04419077|Behavioral|Virtual reality exposure|"Patients will be exposed to a 10-20 min virtual reality session just before an oncological procedure (invasive act or chemotherapy).
~Patients will be able to choose between 4 virtual universes (beach, underwater, forest, space) and seven musical content."
15803882|NCT04419064|Diagnostic Test|Point of care ultrasound|Tracheal and lung ultrasonography
15803883|NCT04419051|Other|Owlet Band|The Owlet Band is a wearable fabric band pregnancy tracker made up of small sensors that are able to detect natural low-level electrical signals normally produced by the mother's heart and baby's (fetal) heart.
15803884|NCT04419038|Procedure|conjunctival autografting augmented with topical application of Mitomycin C|Group A included 32 eyes of 32 patients who underwent conjunctival autografting augmented with topical application of Mitomycin C (0.2 mg/mL).
15803885|NCT04419038|Procedure|conjunctival autografting augmented with Ologen implantation|Group B included 31 eyes of 31 who underwent conjunctival autografting augmented with Ologen implantation.
15803886|NCT04419025|Drug|N-acetylcysteine|Oral formulation: 600 mg capsules of N-acetylcysteine
15803887|NCT04419012|Other|observation|observation
15803888|NCT04418999|Drug|dexamethasone ophthalmic insert 0.4 mg, for intracanalicular use|Experimental
15803889|NCT04418999|Drug|Loteprednol Etabonate 0.38% Ophthalmic Gel/Jelly|Active Comparator
15803890|NCT04418986|Procedure|opposite clear corneal incisions (OCCI)|"Coaxial small incision cataract surgery was performed for all cases using a 2.8 mm keratome placed at steep meridian and 1-mm paracentesis was made 90 degrees apart with a 20-gauge microvitrectomy blade. Surgery was performed with a 30-degree, 0.9-caliper phacoemulsification tip (microtip) with a divide and conquer technique.
~In the OCCI group, a single penetrating incision was created with 2.8 mm keratome in the clear cornea, 1.5 mm anterior to limbal blood vessels, centered over the steep meridian and opposite the phacoemulsification incision."
15803891|NCT04418973|Other|VOCs analysis in exhaled air|using an electronic nose and a mass spectrometry
15803892|NCT04418960|Diagnostic Test|Magnetic resonance imaging (MRI)|MRI pre- and postoperatively for detailed analysis of the ventricle and the mitral annulus. The first MRI will be performed on the admission day before surgery. The second MRI will be performed during the hospital stay, between 3 and 7 days after the operation. The MRI images are interpreted through a specialized cardiologist and radiologist.
15803894|NCT04418934|Device|Hemanext One|Leukoreduced red blood cell product from donors in the Investigational Product arm will be processed in the Hemanext Oxygen Reduction Bag for 3 hours and then transferred to the Hemanext Storage Bag and stored for 56 days at 1-6°C.
15803895|NCT04418921|Behavioral|Self-regulation: MRehab - Un colegio emocionante, clinical trial with non-immersive virtual reality|The principles of the programme will be based on the following premises for children with ASD: 1) Strengthening communicative attempts; 2) Choose the most natural contexts possible; 3) Establish structured and predictable routines and environments; 4)Visually support information; 5) Adapting our language to the understanding level of the child. On the difficulty of interpreting and responding to social emotions and cues, games of perspectives are of great interest, where the child and therapist describe the same object from different perspectives, beliefs (guess that may be in this box), games with social stories, which are short stories that use pictograms, to help understand especially situations with social ambiguity: 1) describing what happens; 2) orienting the action, indicating to the child what to do in that situation; 3) anticipating and explaining what can happen and how you can feel; 4) developing a strategy that can be applied in similar situations.
15803896|NCT04418921|Behavioral|Traditional self-regulation program|The children from control group will follow a program of emotional education of Primary Schools, though group activities in the classroom .The content of the sessions will include 5 sessions of emotional awareness and 5 sessions of emotional and cognitive regulation.Each session will last 50 minutes
15803897|NCT04418908|Drug|Cetrorelix acetate, 0.25 mg/day|All participants self-administered GnRHant daily between the baseline and follow-up visits (cetrorelix acetate, 0.25 mg/day).
15803898|NCT04418908|Drug|Estradiol Patch, 0.025 Mg/24 Hours Weekly Transdermal Film, Extended Release|Active estradiol transdermal patch.
15803899|NCT04418908|Drug|Placebo patch|Placebo patch designed to match active Climara patches.
15803900|NCT04418895|Other|Chemoradiation|Subjects will receive neoadjuvant chemoradiation per standard of care. This is typically comprised of radiotherapy of 5040 cGy (centigray) with concurrent capecitabine 825 mg/m2 by mouth (po) two times daily (bid) (typically rounded to the nearest 500 mg dose) or infusional 5-fluorouracil (5FU). However, dosing and administration are at the discretion of the treating medical and radiation oncologist.
15803901|NCT04418895|Radiation|short course radiation therapy|An acceptable alternative approach is short-course radiation therapy per standard of care, which is typically comprised of radiotherapy of 25 Gy (gray) in 5 fractions, with surgery within 1 week of completion of therapy or delayed for 6-8 weeks. Selection of the optimal radiation therapy approach is at the discretion of the treating medical oncologist, radiation oncologist, and surgical oncologist. However, generally, short-course radiation therapy is not recommended for low-lying tumors less than 5 centimeters (cm) from the anal verge.
15803902|NCT04418895|Drug|mFOLFOX6|possible consolidative neo-adjuvant chemotherapy. This treatment is at the discretion of the treating medical oncologist, radiation oncologist, and surgical oncologist.
15803903|NCT04418895|Drug|CAPOX|possible consolidative neo-adjuvant chemotherapy. This treatment is at the discretion of the treating medical oncologist, radiation oncologist, and surgical oncologist.
15803904|NCT04418895|Drug|fluoropyrimidine +/- oxaliplatin|possible adjuvant chemotherapy regimen. Subjects who do not receive preoperative mFOLFOX6 or CAPOX typically receive postoperative adjuvant chemotherapy with a fluoropyrimidine +/- oxaliplatin for an additional 16-18 weeks of therapy, if permitted based on recovery after surgical resection and post-surgical performance status. This treatment is at the discretion of the treating medical oncologist. Subjects will remain on study regardless of postoperative therapy administration or duration.
15803905|NCT04418882|Other|management and follow up of all open fractures|to evaluate the development of sepsis after an open fracture and then, if there is a development of a pseudarthrosis too.
15803906|NCT04418869|Other|Exercise bouts|Each subject performed three bouts with 45 minutes of exercise (continuous exercise, intermittent exercise and resistance exercise) in a randomized order. In addition a control session were performed where the subjects sat on a chair for 45 minutes.
15803907|NCT04418856|Device|Light Glasses (Experimental)|The light glasses emit light from LEDs at a distance of 15 millimeters (15mm, 0.015.) from the eye. The device is classified as safe for the eyes in accordance with the international standard IEC 62471 and complies with the United States of America's FCC marking, and is designed to be worn on the participant's head, similar to a pair of glasses. For safety purposes, the light glasses do not contain UV or infra-red light.
15803908|NCT04418856|Device|Light Glasses (Comparison)|The light glasses emit light from LEDs at a distance of 15 millimeters (15mm, 0.015.) from the eye. The device is classified as safe for the eyes in accordance with the international standard IEC 62471 and complies with the United States of America's FCC marking, and is designed to be worn on the participant's head, similar to a pair of glasses. For safety purposes, the light glasses do not contain UV or infra-red light.
15803909|NCT04418843|Procedure|Standard Endoscopic Mucosal Resection|Use of injected colloidal or saline solution to raise a lesion prior to polypectomy snare closed over a polyp with electrocautery
15803910|NCT04418843|Procedure|Cold Snare Endoscopic Mucosal Resection|Use of injected colloidal or saline solution to raise a lesion prior to polypectomy snare closed over a polyp without electrocautery
15803911|NCT04418804|Diagnostic Test|Chest ultrasound|"Each research volunteer will undergo a chest-directed ultrasound examination using a commercial device located in the Valley Hospital and approved for clinical use. After completing the above scan, the patient will undergo another ultrasound scan using a Vantage system device (by Verasonics), which is a research ultrasound device that will be provided on loan to the Haemek Hospital by the Weizmann Institute SAMPL Laboratory prior to the start of the trial. The scan will be made with a linear transducer sampled at a rate of about 8-12Mhz and / or with a curved transducer sampled at a rate of about 4-6Mhz.
~The total estimated duration of the test is approximately 30 to 40 minutes per patient."
15803912|NCT04418791|Behavioral|Modified Intermittent Fasting followed by Regular Diet|Modified intermittent fasting (MIF) means fasting for 2 non-consecutive days/week. Fasting is defined as consuming less than 500 kcalories in 1 day (in the course of max. 6 hours). After 12 weeks of fasting, a period of 12 weeks with a regular diet follows.
15803913|NCT04418791|Behavioral|Regular Diet followed by Modified Intermittent Fasting|Regular diet means subject can eat as usual for 12 weeks. Next, a period of 12 weeks fasting follows: modified intermittent fasting (MIF) means fasting for 2 non-consecutive days/week. Fasting is defined as consuming less than 500 kcalories in 1 day (in the course of max. 6 hours).
15803914|NCT04418778|Behavioral|BEAR|Building Empowerment and Resilience Therapy group
15803918|NCT04418752|Other|Psychological therapy|"The National Institute for Health and Care Excellence (2018) specifies NET as a psychological intervention for the treatment of PTSD or prominent symptoms of PTSD in adults. NET is a short-term treatment which incorporates elements of CBT exposure therapy and testimonial therapy. In exposure therapy, clients are encouraged to repeatedly discuss traumatic experiences in detail, including emotions and sensory experiences (Schauer, Elbert, & Neuner, 2011).Testimonial therapy involves the construction of a detailed and coherent report of the survivor's biography including an explicit description of the traumatic events (Neuner, Schauer, Roth & Elbert, 2002, pp.5-6). Therefore, NET aims to embed the traumatic experience within the context of the person's life and the mechanisms of change are theorised to be exposure and habituation to the traumatic experience and the reconstruction of autobiographical memory."
15803919|NCT04418739|Drug|Human albumin|Intravenous human albumin given at a maximum dose of 1g/kg at skin incision which is infused at 100ml/hour
15803920|NCT04418726|Other|Intensified Monitoring|Apart from clinical assessment, use non-invasive devices to check for the haemodynamic consequences of stenosis by measuring Qa, using either indicator dilution techniques or duplex ultrasound every month.
15803921|NCT04418713|Other|active video-games|An intervention with active video-games to increase physical activity and improve body composition
15803922|NCT04418700|Device|Breath Stacking|The patients will perform the maneuver through successive inspiratory efforts for 20 s. Subsequently, the expiratory branch will be unobstructed to allow expiration. This maneuver will be repeated 5 times in each series, with intervals of 30 seconds between them. The technique will be performed with the trunk inclined 30º in relation to the horizontal plane, in 3 series, with interval of 2 min completing 15 min of therapy.
15803923|NCT04418687|Device|Orthoglide|Knee rehabilitation device.
15803924|NCT04418687|Other|Physiotherapy only|Physiotherapy only.
15803925|NCT04418674|Drug|Ketamine|in this group, patient will receive ketamine at 0.3mg/kg intravenously.
15803926|NCT04418674|Drug|Fentanyl|In this group, the patients will receive fentanyl at 1.5mcg/kg intavenously.
15803927|NCT04418661|Drug|SAR442720|Pharmaceutical form:Capsule Route of administration: Oral
15803928|NCT04418661|Drug|Pembrolizumab|Pharmaceutical form:Sterile Lyophilized powder for reconstitution Route of administration: Infusion
15803929|NCT04418648|Drug|Toripalimab|Toripalimab consolidation (240 mg) via iv infusion once every 3 weeks. Administration of toripalimab will commence on Day 1 following randomisation to toripalimab after confirmation of eligibility and will continue on a Q3W schedule for a maximum duration of 6 months.
15803930|NCT04418635|Dietary Supplement|Prosta-OK® Neo or Prosta-OK® Neo-matched placebo|the patient planed to receive Tamsulosin 0.2mg once daily is randomized to the experiment group or placebo group. After randomization, the patient received Tamsulosin therapy with Prosta-OK® Neo or Prosta-OK® Neo-matched placebo 707mg 2 tablets twice daily for 85 days.
15803931|NCT04418609|Other|further processing of health data|further processing of biological materials and health related personal data for research
15803932|NCT04418596|Radiation|bi-planer radiography (EOS), Conventional rediography (Hip+pelvis)|low dose radiation medical imaging to visualise the hip joint and lumbo-pelvic complex specifically.
15803933|NCT04418583|Diagnostic Test|Three-dimensional imaging|Three-dimensional surface images, acquired by the Artec Leo
15803934|NCT04418570|Behavioral|cognitive remediation|
15803935|NCT04418570|Other|attendance to an Early Intervention Service for Psychosis|
15803936|NCT04418557|Diagnostic Test|RT-PCR and antibody testing|Testing of amniotic fluid, cord blood, amnion and chorion, umbilical cord, vaginal mucous, maternal and neonatal sera, neonatal throat swab, and breast milk.
15803937|NCT04418544|Device|Device used to record voice for screening|voice recording
15803938|NCT04418531|Biological|Anti-coronavirus antibodies (immunoglobulins) obtained with DFPP form convalescent patients|Antibodies obtained from consenting convalescent donors will be administered to ten consecutive patients who fulfill the inclusion criteria .
15803939|NCT04418505|Device|Vielight RX Plus|The Vielight RX Plus is designed to deliver near-infrared light and red light via LEDs placed directly on the manubrium of the sternum (which covers the thymus gland) and inside one nostril, respectively.
15803940|NCT04418492|Behavioral|Skills for Adaptive Functioning through Executive training (SAFE; tentative title)|An intervention program to improve adaptive skills and executive functions in young adults with high-functioning autism spectrum disorder was administered weekly for 10 weeks to the participants. The participants also completed pre-, mid- and post-intervention assessments.
15803941|NCT04418479|Drug|Aspirin|"Randomization will be performed 1:1 between clopidogrel and aspirin monotherapy in patients being treated with dual antiplatelet therapy (DAPT) at high risk for recurrent ischemic events who have been over 12 months after percutaneous coronary intervention (PCI) with drug-eluting stent (DES).
~This group will be taken aspirin 100 mg once daily during the study period."
15803942|NCT04418479|Drug|Clopidogrel|"Randomization will be performed 1:1 between clopidogrel and aspirin monotherapy in patients being treated with dual antiplatelet therapy (DAPT) at high risk for recurrent ischemic events who have been over 12 months after percutaneous coronary intervention (PCI) with drug-eluting stent (DES).
~This group will be taken clopidogrel 75 mg once daily during the study period."
15803943|NCT04418466|Combination Product|Risperidone|Risperidone Implant
15803944|NCT04418453|Other|Integration of telemedicine for MOUD in primary care|Patients with opioid use disorder in rural primary care settings may be referred to receive telemedicine for medication treatment for opioid use disorder
15803945|NCT04418440|Dietary Supplement|Souvenaid oral nutritional supplement (Nutricia)|Daily dose of a commercially available oral nutritional supplement based around the active compound recipe Fortasyn Connect, produced by Nutricia, Danone.
15803946|NCT04418427|Biological|6E11 vg/eye of ADVM-022|ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-deficient adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept
15803947|NCT04418427|Biological|2E11 vg/eye of ADVM-022|ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-deficient adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept
15803948|NCT04418427|Biological|Aflibercept|Commercially available Active Comparator
15803949|NCT04418414|Drug|Gene therapy|CD34+ hematopoietic stem cells transduced with CD68-ET3 lentiviral vector (encoding human factor VIII gene) is administered by IV infusion following conditioning regimen with busulfan and anti-thymocyte globulin.
15803950|NCT04418414|Other|Biological|G-CSF and Plerixafor are administered by subcutaneous injection prior to apheresis.
15803951|NCT04418401|Drug|Donafenib and anti-PD-1 antibody|Donafenib was taken orally twice daily, and anti-PD-1 antibody was applied biweekly.
15803952|NCT04418388|Drug|PBK-1801|Administered orally
15803953|NCT04418388|Drug|PBK-1801|Administered orally
15803954|NCT04418388|Drug|PBK-1801|Administered orally
15803955|NCT04418362|Other|Neurofeedback training|A home-based self-administered neurofeedback intervention taking place 4-6 times per week for 8 weeks.
15803956|NCT04418349|Procedure|"posterior component separation modified TAR technique Transversus Abdominids Release"|"Evaluation of posterior component separation modified TAR technique Transversus Abdominids Release in the treatment of parastomal hernia"
15803957|NCT04418336|Procedure|Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique|Endoscopic Pilonidal sinus treatment (EPSIT) versus Sinus Laser Closure (SiLaC) versus lay open technique in sacrococcygeal Pilonidal sinus treatment
15803958|NCT04418323|Procedure|Video-assisted anal fistula treatment (VAAFT) versus Fistula-tract Laser Closure (filac) versus Conventional seton in the Management of anal fistula|Video-assisted anal fistula treatment (VAAFT) versus Fistula-tract Laser Closure (filac) versus Conventional seton in the Management of anal fistula
15803959|NCT04418310|Procedure|Lay open and curettage|Lay open and curettage
15803960|NCT04418310|Procedure|Endoscopic (E.P.Si.T) method|Endoscopic (E.P.Si.T) method
15803961|NCT04418297|Drug|CT-G20|oral tablet
15803962|NCT04418297|Drug|Placebo|oral tablet
15803963|NCT04418284|Other|survey|online survey
15803964|NCT04418271|Behavioral|Prehabilitation- new form of care|The participants in the intervention group take part in a shared decision-making (SDM) conference to plan the intervention. The therapeutic content of the prehabilitation is defined individually for each patient in the SDM conference. Prehabilitation will be a structured and individually tailored 3-week program.
15803965|NCT04418258|Device|Capillary Endoscopy Aspiration Catheter|Small intestinal fluid will be suctioned with using a capillary endoscopy aspiration catheter[#CSL2182; Hobbs Medical,Inc. Connecticut, US] during upper endoscopy
15803966|NCT04418258|Device|Endoscopy Aspiration Catheter|Small intestinal fluid will be suctioned with using an endoscopy aspiration catheter[#2182; Hobbs Medical,Inc. Connecticut, US] during upper endoscopy
15803967|NCT04418245|Diagnostic Test|Imaging by thoracic scanner|Low-dose computed tomography
15803968|NCT04418232|Combination Product|Alianza Latina|The main components of Alianza Latina are 1) providing primary care providers with education, training and tools for timely dementia diagnosis and optimal treatment and 2) providing Latino dementia patients with enhanced chronic care through bilingual Health Navigators.
15803969|NCT04418219|Drug|Cyclophosphamide|alkylating agent used in the treatment of several forms of cancer including leukemias, lymphomas and breast cancer.
15803970|NCT04418219|Biological|Allogeneic GM-CSF-secreting Breast Cancer Vaccine SV-BR-1-GM|Breast Cancer Vaccine SV-BR-1-GM, Bria-IMT, GM-CSF Gene-transfected Breast Cancer Vaccine SV-BR-1-GM, SV-BR-1 Breast Cancer Cell Line Vaccine, SV-BR-1-GM, SV-BR-1-GM Vaccine
15803971|NCT04418219|Biological|Pembrolizumab|1374853-91-4, Immunoglobulin G4, Anti-(Human Programmed Cell Death 1); Humanized Mouse Monoclonal (228-L-proline(H10-S>P))gamma 4 Heavy Chain (134-218'')-disulfide with Humanized Mouse Monoclonal Kappa Light Chain Dimer (226-226'''':229-229'''')-bisdisulfide, Keytruda, Lambrolizumab, MK-3475, PEMBROLIZUMAB, SCH 900475
15803972|NCT04418219|Biological|Recombinant Interferon Alpha 2b-like Protein|Novaferon, Recombinant IFN Alfa-2b-like Protein
15803973|NCT04418219|Other|Questionnaire Administration|Ancillary studies
15803974|NCT04418219|Other|Quality of Life Assessment|Ancillary studies
15803975|NCT04418206|Other|patients COVID 19|Exposure to SARS-Cov2 but no symptoms (patient's family, medical staff) and General population (volunteers not exposed to SARS-Cov2)
15803976|NCT04418180|Drug|Fenofibrate|Patients were randomly assigned to receive oral fenofibrate 10 mg/kg/hr
15803977|NCT04418180|Drug|Placebo|oral distilled water
15803978|NCT04418167|Drug|JSI-1187|JSI-1187 capsules for oral administration
15803979|NCT04418167|Drug|Dabrafenib|Dabrafenib capsules for oral administration
15803980|NCT04418154|Drug|epirubicin hydrochloride|Take epirubicin hydrochloride (90mg/m2, d1) every 14 days as one cycle for 4 cycles with cyclophosphamide, followed by nanoparticlealbumin-bound paclitaxel and Toripalimab.
15803981|NCT04418154|Drug|Cyclophosphamide|Take cyclophosphamide (600mg/m2, d1) every 14 days as one cycle for 4 cycles with epirubicin hydrochloride, followed by nanoparticlealbumin-bound paclitaxel and Toripalimab.
15803982|NCT04418154|Drug|Albumin bound paclitaxel|Take nanoparticlealbumin-bound paclitaxel (125mg/m2, d1) per week for 3 weeks as one cycle for 4 cycles with Toripalimab, following epirubicin hydrochloride and cyclophosphamide.
15803983|NCT04418154|Drug|Toripalimab|Take Toripalimab (240mg, d1) every 3 weeks as one cycle for 4 cycles with nanoparticlealbumin-bound paclitaxel, following epirubicin hydrochloride and cyclophosphamide.
15803985|NCT04418128|Drug|Nafamostat Mesylate|The Nafamostat mesilate group received continuous intravenous infusion of 0.1-0.2 mg/kg/h of nafamostat mesilate mixed with 5% DW.
15803986|NCT04418115|Other|Acupuncture; based on Tradidtional Chinese Medicine|Acupuncture is a form of treatment that involves inserting very thin needles through a person's skin at specific points on the body, to various depths. Research suggests that it can help relieve pain, and it is used for a wide range of other complaints.
15803987|NCT04418102|Dietary Supplement|Palmitic acid rich interesterified fat|Muffins and spread containing the palmitic acid rich IE fat will be consumed daily for a 6-week dietary intervention period
15803988|NCT04418102|Dietary Supplement|Stearic acid rich interesterified fat|Muffins and spread containing the palmitic acid rich IE fat will be consumed daily for a 6-week dietary intervention period.
15803989|NCT04418089|Drug|Simvastatin 40mg|The administration of Simvastatin 40 mg in addition to neoadjuvant chemoterapy CAF
15803990|NCT04418089|Drug|Placebo oral capsule|The administration of Placebo capsule 40 mg in addition to neoadjuvant chemoterapy CAF
15803991|NCT04418076|Device|Group A_No feedback|In the control (Group A), the feedback option will be deactivated on the device on the TowerView Health® smart pill box, effectively serving to only monitor natural pill-taking patterns.
15803992|NCT04418076|Device|Group B_Automated feedback|For participants in Group B (automated feedback), missed dosages will prompt an automated text message to be sent to the participants' smartphone. The TowerView Health® pill box consists of in-built alarm and flashing color lights, and the ability to send text messages to the participants' phone either as reminder in the event of missed dosage or a message of encouragement when all dosages are taken.
15803993|NCT04418076|Device|Group C_Automated feedback + Clinician feedback|For participants in Group C, the survey app responses will be assessed each week by the RA who in turn will communicate the results to a clinical nurse. The clinical nurse will be funded through this study; he/she will be responsible for providing personalized feedback to all Group C participants. The clinic nurse will contact the subject with appropriate feedback about their health behavior and suggestions for sustained adherence.
15804092|NCT04417218|Dietary Supplement|Lysine|Lysine is an essential amino acid which is acquired from dietary sources.
15803994|NCT04418076|Device|Group D_Automated feedback + Social Network feedback|For participants in Group D, a social network designee will be chosen based on the names provided by the participants during screening. One social network designee will be consented and chosen to send the participant a weekly text reminder the participant to take their medication. The text for the message will be chosen by the social network designee.
15803995|NCT04418050|Procedure|Shoulder arthroplasty|Surgery consisting in replacement of gleno-humeral joint by a shoulder prosthesis
15803996|NCT04418037|Device|Digital Health Feedback System(DHFS)|We will investigate the feasibility of using the DHFS in hospitalized individuals living with HIV to support ARV adherence.
15803997|NCT04418024|Drug|AG10|TTR stabilizer administered orally twice daily (BID)
15803998|NCT04418024|Drug|Placebo|Non-active control
15803999|NCT04418011|Device|Repetitive Transcranial Magnetic Stimulation|"The present study aims to use both repetitive transcranial magnetic stimulation (rTMS) and intermittent theta burst stimulation (iTBS), safe and effective forms of neuromodulation, to target the neural circuitry of social cognitive (SCog) impairments in people with SSDs. Treatment sessions will be administered five days per week for two weeks.
~Other Name: MagPro X100 or R30 (Medtronic A/S. Copenhagen, Denmark) equipped with a Cool-B70 A/P coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark), positioned under MRI guidance using the Brainsight neuronavigation system (Rogue Resolutions, Montreal, Canada) or Localite (Localite GmbH, Bonn, Germany)"
15804000|NCT04418011|Device|Repetitive Transcranial Magnetic Stimulation (Intermittent Theta Burst Stimulation)|"The present study aims to use both repetitive transcranial magnetic stimulation (rTMS) and intermittent theta burst stimulation (iTBS), safe and effective forms of neuromodulation, to target the neural circuitry of social cognitive (SCog) impairments in people with SSDs. Treatment sessions will be administered five days per week for two weeks.
~Other Name: MagPro X100 or R30 (Medtronic A/S. Copenhagen, Denmark) equipped with a Cool-B70 A/P coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark), positioned under MRI guidance using the Brainsight neuronavigation system (Rogue Resolutions, Montreal, Canada) or Localite (Localite GmbH, Bonn, Germany)"
15804001|NCT04418011|Device|Repetitive Transcranial Magnetic Stimulation (Sham)|Other Name: MagPro X100 or R30(Medtronic A/S. Copenhagen, Denmark) equipped with a Cool-B70 A/P coil and Qooler fluid-cooling device (MagVenture, Farum, Denmark), positioned under MRI guidance using the Brainsight neuronavigation system (Rogue Resolutions, Montreal, Canada) or Localite (Localite GmbH, Bonn, Germany)
15804002|NCT04417998|Drug|18F-FDG|A cohort of participants in Aim 2 will undergo a 18F-FDG PET/CT scan. This scan is done with a radiotracer called 18F-fluorodeoxyglucose (FDG). FDG looks at cellular activity.
15804003|NCT04417998|Drug|18F-AV1451|A cohort of participants in Aim 2 will undergo a 18F-AV1451 PET/CT scan. This scan is done with a radiotracer called 18F-AV1451 (TAU) that will find small areas of tau (abnormal protein) in the brain.
15804004|NCT04417998|Device|Siemens E7 Reconstruction Tool|Software to correct for motion
15804005|NCT04417985|Device|18F-FDG PET/CT, MRI|
15804006|NCT04417972|Drug|SHR7280|treatment
15804007|NCT04417972|Drug|Placebo oral tablet|blank control
15804008|NCT04417959|Procedure|Phaco-DSAEK|The intervention will be performed as a DSAEK triple-procedure with phacoemulsification and intraocular lens implantation prior to DSAEK.
15804009|NCT04417959|Procedure|Phaco-DMEK|The intervention will be performed as a DMEK triple-procedure with phacoemulsification and intraocular lens implantation prior to DMEK.
15804010|NCT04417946|Behavioral|PrEP messages|The peer leaders and the study staff will post PrEP related health messages
15804011|NCT04417946|Behavioral|Heath messages|The peer leaders and study staff will post general health messages that are not related to sexual health
15804012|NCT04417933|Device|Tumor Electric Fields Treatment System|Patients wear two pairs of electrodes on the head for 19-22 hours a day. Each patient is required to wear the device as long as possible and not less than 6 months. The treatment has a two-day break for every four weeks.
15804013|NCT04417920|Procedure|Express implant device|"Operative technique in group I (Express implant) was as in group II (trabeculectomy) except with no sclerectomy or peripheral iridectomy , the steps included conjunctival peritomy superior-temporally away from the site of the fibrotic bleb at 12 o'clock, placed on the episclera under the conjunctiva and Tenon's capsule for a contact time of 3 minutes, ,triangular scleral flap , scleral dissection forward to the clear cornea to allow exposure of scleral spur then creation of a pilot hole is fashioned using a sapphire blade (Alcon laboratories,USA) then Express shunt 3 mm long device and external diameter 400 microns was implanted followed by closure of scleral flap and conjunctiva.
~While in group II, Trabeculectomy with Mitomycin-C was done in superior-temporal region away from the fibrotic bleb at 12 o, clock."
15804018|NCT04417894|Drug|dupilumab|Solution for subcutaneous (SC) injection administration
15804019|NCT04417894|Drug|Placebo|Solution for SC injection administration
15804020|NCT04417881|Other|MEESSI score|MEESSI score in predicting mortality and readmission of patients managed for acute heart failure (AHF) in Emergency Department.
15804021|NCT04417855|Diagnostic Test|G-Walk|"Every individual will be examined with a non-invasive G-Walk device which is a sensor mounted on a belt and fasten on individuals' lumbar spine region during two test activities: Timed up and go and 6-meter walk tests. Data collection will include kinematic parameters. Oswestry Disability Index (ODI) score will also be collected."
15804022|NCT04417842|Diagnostic Test|Respimetrix flow-volume monitoring device|The Respimetrix flow-volume monitoring device is being tested to validate its ability to measure Inspiratory Capacity
15804023|NCT04417829|Device|Biological prosthesis in the aortic valve|Transcatheter aortic valve implantation of bioprosthesis in patients with severe symptomatic aortic stenosis (clinically indicated)
15804024|NCT04417816|Other|Exercise training intervention with ultrasound induced adipose tissue cavitation|Exercise training intervention with ultrasound induced adipose tissue cavitation
15804127|NCT04416971|Procedure|AVF puncture|For patients with mature/immature AVF on HD initiation, AVF puncture will be conducted.
15804025|NCT04417816|Other|Exercise training intervention without ultrasound induced adipose tissue cavitation|Exercise training intervention with ultrasound induced adipose tissue cavitation
15804026|NCT04417803|Biological|Blood sampling|plasmatic sampling
15804027|NCT04417790|Diagnostic Test|Lung ultrasound and EVLW measurement by transpulmonary thermodilution.|Lung ultrasonography by 8 Quadrant protocol of Volpicelli et al. Transpulmonary thermodilution for extravascular lung water measurement
15804028|NCT04417777|Genetic|Blood Test|Blood analysis
15804029|NCT04417764|Procedure|Transcatheter arterial chemoembolization|The patients are plan to operated by Transcatheter arterial chemoembolization(TACE).
15804030|NCT04417764|Biological|PD-1 knockout engineered T cells|The PD-1 knockout engineered T cells are prepared from autologous origin using CRISPR Cas9 technology. The patients are plan to receive 3 or more cycles of PD-1 knockout engineered T cells infusion by percutaneous fine needle liver puncture with a 4-weeks interval. A total of 1 to 3× 10^9 PD-1 edited T cells will be infused each cycle. Patients continued receiving treatment unless they had unacceptable adverse effects, or progressive disease confirmed by CT or they withdrew consent.
15804031|NCT04417751|Behavioral|Cognitive Stimulation|The intervention includes 50 sessions, over the course of one year, being that 3 of those sessions will be the pretest, intratest and posttest evaluations. The intervention sessions will last approximately 45 minutes and they will be developed according to the following structure: welcoming and greeting the participants (5 minutes); reality orientation therapy (10 minutes), cognitive stimulation [CS] activity (25 minutes); return to calm and closure of the session, and session evaluation (5 minutes). CS sessions will be conducted in an individual intervention format. The intervention sessions will include several activities based on different non-pharmacological therapies (e.g., reminiscence therapy, reality orientation therapy, cognitive training) whose effectiveness in older adults with neurocognitive disorders has been scientifically proven. All individual CS sessions will be conducted by one therapist (clinical psychologist) with more than five years of experience in CS.
15804032|NCT04417738|Device|unilateral transcranial photobiomodulation, near infrared mode|The investigators are applying a supra luminous LED at 810 nm and 250 mW/cm2 to the forehead of the participant at F3 and F4.
15804033|NCT04417738|Device|Sham treatment|The sham treatment is identical to the active treatment except that the sham treatment has a piece of aluminum foil covering the led so that the participant will experience warmth but receive no photons.
15804034|NCT04417712|Device|KONAR-MF™ VSD Occluder|All patients will be implanted with a KONAR-MF™ VSD Occluder in accordance with the instructions for use (IFU).
15804035|NCT04417699|Drug|TAS 102|Oral medication over Days 1-5
15804036|NCT04417699|Drug|Oxaliplatin|Administered by intravenous infusion over 2 hours on day 1
15804037|NCT04417686|Procedure|arterial embolization|arterial embolization of the geniculated arteries for reduction of pain after installation of total knee prosthesis
15804039|NCT04417647|Device|VZ powder (purified clinoptilolite)|VZ powder will be applied topically to the open surface of the verum treatment-assigned wound to cover the entire wound area. Following each VZ application, wounds will be protected by wound dressing (non-adhesive wound dressing (AdapticTM) and conventional protective Mepore® dressing).
15804040|NCT04417647|Procedure|Standard of care (SoC)|wound cleansing (0.9% saline solution) and wound dressing (non-adhesive wound dressing (AdapticTM) and conventional protective Mepore® dressing) will be applied to the SoC-assigned wound.
15804041|NCT04417634|Diagnostic Test|RFR|Measurement of resting flow ratio
15804042|NCT04417634|Diagnostic Test|FFR|Measurement of fractional flow reserve
15804047|NCT04417608|Procedure|Infraclavicular brachial plexus block|Ultrasound-guided infraclavicular brachial plexus block
15804048|NCT04417595|Drug|Fish Oil (Containing Omega-3 Acids)|Fish Oil Supplement
15804049|NCT04417595|Drug|Olive Oil|Olive Oil Supplement
15804050|NCT04417582|Procedure|bariatric surgey|patients undergone bariatric surgery or prescribed antiobesity drugs
15804051|NCT04417569|Drug|hCG|human chorionic gonadotropin
15804052|NCT04417569|Diagnostic Test|Ultrasound|Endometrial thickness monitoring
15804053|NCT04417569|Other|Blood test|Progesterone, Luteinizing Hormone, Estradiol
15804054|NCT04417556|Diagnostic Test|Sleep measurement|Sleep measurement with polysomnography, actigraphy, and Thai-version Richards Campbell Sleep Questionnaire.
15804055|NCT04417543|Drug|Memantine Hydrochloride|Memantine is a low-affinity voltage-dependent uncompetitive antagonist of the NMDA-type glutamate receptor .Memantine hydrochloride tablet was started at the dose of 5 mg once daily orally, and the same dose was given for 3months and dose is titrated to 10 mg once daily orally for the remaining 3months. Placebo was given once daily orally for6months. Patients were instructed to take the study medication at the same time every day.
15804056|NCT04417543|Drug|Placebo|Placebo was given once daily orally for6months. Patients were instructed to take the study medication at the same time every day.
15804059|NCT04417517|Drug|evorpacept|Fusion protein that blocks CD47-SIRPalpha pathway
15804060|NCT04417517|Drug|azacitidine|Hypomethylating agent (HMA)
15804061|NCT04417504|Other|MobFood breakfast kit|Cereal biscuit with orange fruit, cheese with fruit preparation and beverage based on oat, milk and mocha (without added sugar), specifically developed for the project MobFood_PPS4.
15804062|NCT04417504|Other|Control isocaloric breakfast|White bread, butter and milk.
15804063|NCT04417491|Device|Dry Needling|Real dry needling will be conducted according to the fast-in and fast-out principle. The intervention will be applied until a total of four local twitch responses will be elicited
15804251|NCT04415879|Device|N-95 Respirator|N-95 mask will be worn as personal protective equipment during a graded exercise test
15804064|NCT04417491|Device|Sham Needling|Sham dry needling with be conducted with a sham needle device. This needle has a blunt tip and retractable handle that created the illusion of a needle penetrating the skin. When this needle touches the skin, a pricking sensation will be created. However, when pressure will be increased, the shaft of the needle disappears into the handle creating a sensation on the patient
15804065|NCT04417478|Other|Scaling and root planning|Periodontal debridement was performed in all patients.
15804066|NCT04417465|Drug|ABBV-CLS-579|Oral Capsule
15804067|NCT04417465|Drug|Programmed Cell Death-1 (PD-1) Inhibitor|Intravenous (IV) infusion
15804068|NCT04417452|Other|Basic data collection (online survey or written form)|Basic data collection is carried out by means of a questionnaire that participants can fill in outside the study centre. It contains questions about the current life situation, sleep and activity behaviour.
15804069|NCT04417452|Other|Physical examination|The physical examination takes place at the study centre and includes the measurement of height, current weight and body fat, as well as the recording of heart and circulation parameters (e.g. blood pressure measurement or determination of vascular health by means of ultrasound). General metabolic and hormonal parameters are analysed by means of a blood sample. In addition, a sugar test for diabetes diagnosis will be carried out.
15804070|NCT04417452|Behavioral|Psychometric examination|Psychometric examination is carried out at the study centre with the help of a RIAS test.
15804071|NCT04417452|Diagnostic Test|Recording of the adrenergic stress reaction (saliva test)|The adrenergic stress reaction is recorded by a saliva test.
15804072|NCT04417439|Other|universal goniometer. evaluate the circumference measurement. The biochemical examination of CK (creatine kinase)|The joint range of motion within the affected areas of burn patients was assessed by a universal goniometer. A 7-mm-wide tape measure was used to evaluate circumference measurement in individuals. The biochemical analysis of CK (creatine kinase) was performed by an expert on blood samples taken from patients in the hospital laboratories.
15804073|NCT04417426|Other|Survey|A survey was conducted, which was filled voluntarily and completely anonymously; the demographic data asked were: sex, age, religion, and semester. We included questions about their sexual behavior: if they considered having enough knowledge about STDs, sexual intercourse onset, number of sexual partners in the last year, the total number of sexual partners, sexual orientation, the use of condoms and contraceptives, exclusive or non-exclusive sexual intercourses, frequency of STDs screening, and then if they know the location of STD testing centers.
15804074|NCT04417413|Device|Fotona ProlapLase|Non-ablative SMOOTH mode intravaginal Er:YAG teratment for pelvic organ prolapse
15804075|NCT04417400|Behavioral|medicines use review|The provision of MUR service as defined in the SOP MUR (Slovene Chamber of Pharmacies). It is classified as a type 2a review (PCNE typology) and it is intended for the patients to support them in regular and proper medicines use. MUR is performed based on medication history and information provided by the patient in a purposely scheduled conversation with the pharmacist. Pharmacists must be certified to provide MUR. MUR goal is to identify DRPs and recommend interventions to resolve them. During the MUR interview, the pharmacist completes a working sheet that records information regarding medicines, identified DRPs and recommended interventions. After the MUR interview, patients are provided with a personal medicines card that contains all the information that is needed to support effective and safe medicines use (dosing regimen, taking with/without food, special warnings, recommendations, etc.).
15804076|NCT04417387|Other|Observational|
15804077|NCT04417374|Other|Description of groups caracteristics|Comparison of the two groups on all the following criterias : age, sex, if the patient lives alone, the matter of hospitalization, its lengh, their primary psychiatric diagnostic, the use of toxics at the moment of the hospitalization and if this psychiatric decompensation happens in a context of treatment interruption.
15804078|NCT04417361|Drug|Galcanezumab Prefilled Syringe|Galcanezumab will be supplied in preloaded syringes, each with a dose of 120 mg. Participants will first receive the first month's supply (240 mg) at study visit 2, and then will receive a two month supply at study visit 3. So, at study visit 2 and 3, each participant will get two pre-filled syringes.
15804079|NCT04417361|Drug|Placebo|Placebo will be supplied in preloaded syringes, each with a dose of 120 mg. Participants will first receive the first month's supply (240 mg) at study visit 2, and then will receive a two month supply at study visit 3. So, at study visit 2 and 3, each participant will get two pre-filled syringes.
15804080|NCT04417348|Drug|Retinoic acid|To evaluate the role of Opsin receptors in melasma. The patients were treated with 0.05% Retinoic Acid, a regular therapy to treatment melasma, a ligand of Opsin receptors. Also, Uv-Visible light filter treatment as a posible opsin receptor blocker
15804081|NCT04417335|Biological|BCG vaccine|Bacille Calmette-Guérin is a live attenuated strain of Mycobacterium bovis developed in 1921 to prevent tuberculosis and other mycobacterial related infections.
15804082|NCT04417335|Biological|Placebo|0.9% NaCl
15804083|NCT04417322|Other|observation of serum A.actinomycetemcomitans levels|Analysis of serum A.actinomycetemcomitans levels
15804084|NCT04417309|Behavioral|Experimental|Behavioral: Moderate Intensity Exercise The moderate-intensity aerobic exercise session will consist of walking or running at a moderate intensity (i.e., between 70-75% MHR) for 30 minutes.
15804085|NCT04417309|Behavioral|Active Control|Behavioral: Low Intensity Exercise Control participants will maintain light-intensity activity (i.e., walking at ~50% of MHR) for 30 minutes.
15804086|NCT04417296|Diagnostic Test|antepartum computerised cardiotocography analysis|A common obstetric methodical to evaluate the fetal well-being is the antepartum fetal heart rate (FHR) monitoring through cardiotocography (CTG)
15804087|NCT04417270|Device|Freestyle Libre 14 day CGM system|The FreeStyle Libre 14 day system is a continuous glucose monitoring system consisting of a handheld reader and a sensor worn on the back of the upper arm.
15804088|NCT04417270|Device|Accuchek Inform II platform|The Accu-Chek Inform II system is designed to deliver data with speed and efficiency, helping to provide optimal care. Wireless meter quickly transfers data. The Accu-Chek Inform II system is the first point-of-care blood glucose device to offer truly wireless technology at the meter level.
15804089|NCT04417257|Drug|LAU-7b|LAU-7b will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
15804090|NCT04417257|Drug|Placebo oral capsule|Placebo will be administered orally once-a-day with the main meal of the day, if possible, for a total of up to 14 days.
15804091|NCT04417231|Device|CRP apheresis|"Selective CRP apheresis by use of the PentraSorb-CRP"
15804093|NCT04417218|Dietary Supplement|Controlled Diet|Individuals will be instructed to consume specific foods, to adhere to a controlled lysine diet.
15804094|NCT04417205|Other|Carbohydrate Rich Breakfast|Participants will be asked to consume the provided carbohydrate rich breakfast before 1000h daily for 28 days.
15804095|NCT04417205|Dietary Supplement|Whey protein enriched breakfast|Participants will be asked to consume the provided whey protein enriched breakfast before 1000h daily for 28 days.
15804096|NCT04417192|Drug|Olaparib|Olaparib will be administered at a dose of 300mg as oral dose, twice a day.
15804097|NCT04417192|Drug|Pembrolizumab|Pembrolizumab will be administered at a dose of 200mg as a 30-minutes IV infusion, Q3W (25 minutes to 40 minutes are acceptable).
15804098|NCT04417179|Procedure|transversus abdominis block|transversus abdominis block
15804099|NCT04417179|Procedure|Erector spinae block|Erector spinae block
15804100|NCT04417179|Drug|Bupivacaine 0.25% Injectable Solution|Local Anesthetic used in both blocks
15804101|NCT04417179|Device|Siemens Acuson x300 3-5MHz Ultrasound|Ultrasound used to aid in the blocks
15804102|NCT04417166|Drug|Pembrolizumab|50 mg powder for concentrate for solution for infusion
15804103|NCT04417166|Radiation|Involved Field Radiation Therapy|"50-54 Gy Involved Field Radiation Therapy (IFRT) as proposed by the International Lymphoma Radiation Oncology Group (ILROG) guidelines. 50 Gy is recommended in patients without primary tumor invasiveness (invasion to adjacent tissue and/or organs), 54 Gy in locally advanced cases (invasion to adjacent tissue and/or organs) or with other risk factors (age > 60 years, stage II, elevated serum LDH levels).
~Intensity modulated radiation therapy (IMRT) and volumetric modulated arc therapy (VMAT) are recommended but not mandatory; 3-dimensional conformal RT (3D-CRT) is allowed."
15804104|NCT04417153|Behavioral|Mindfulness Based Intervention|The mindfulness-based intervention consists of either four (MF) or eight (MBSR) 2-hour sessions covering various mindfulness techniques (e.g. mindfulness of breath, body and movement, senses and informal practice, and empathy and compassion). Participants will be provided handouts for the information covered during these talks and discussions.These can be done either face to face or online.
15804105|NCT04417140|Biological|dHACM (AmnioWrap)|Dehydrated human amnion-chorion membrane (dHACM) is a healing adjunct that has been applied in a broad range of disease, and is FDA registered for wound healing.
15804106|NCT04417127|Other|Integrated Community-Based (ICB) Care|The intervention will include the following components: (1) integrated care visits by clinical team occurring monthly during months 1-6 of the trial, and then quarterly for the remaining months (7-18), which include vital signs screening, consultation with a clinical officer, medication distribution (ART and other chronic and acute medications), and point- of-care (POC) laboratory testing (creatinine, blood glucose and hemoglobin A1C, and viral load as it becomes available); (2) peer support for promoting ART adherence during every monthly MF meeting; (3) referrals to facilities for emergency or acute care needs that are not feasible to address in the community. Integrated care refers to delivery of primary, HIV and NCD-related care, incorporating a focus on both chronic and acute needs.
15804107|NCT04417127|Other|Microfinance|"Group microfinance uses a client-driven model that involves community savings groups where members mobilize and manage their own savings, provide interest-bearing loans to group members, offer a limited form of financial insurance, and contribute to a social fund that is used for income-generating activities and in cases of emergency or welfare issues of group members.
~For this study, group microfinance will refer to existing, active AMPATH Group Integrated Savings for Empowerment (GISE) microfinance groups with a majority of group members who are AMPATH HIV patients and have disclosed their HIV status. Groups will be considered active if the group was formed at least 6 months prior to study baseline, is consistently meeting as scheduled, and is actively engaging in saving and loaning."
15804108|NCT04417114|Drug|Rosuvastatin|Statin
15804109|NCT04417101|Drug|Chinese Herb|The participants will be instructed to take their JBT and take it as a dose of 3 g (per bag) each time, trice daily for 4 weeks.
15804110|NCT04417088|Drug|Carboplatin|Carboplatin infusion on the day of Exablate BBBD procedure to treat cancerous cells in the brain
15804111|NCT04417088|Device|Exablate BBBD|BBB opening via Exablate Neuro Type 2 system with microbubble resonators.
15804112|NCT04417075|Behavioral|Impacto (Mobile App)|This is the mobile app to be developed and evaluated in this project. It is designed for Spanish-speaking, Latinx smokers with high anxiety sensitivity and will be built for the Android platform. The app will include components to address and remediate anxiety sensitivity, as well as having smoking cessation components.
15804113|NCT04417075|Behavioral|Dejar de Fumar Asistente (Mobile App)|Dejar de Fumar Asistente (English version called: Quit Tracker: Stop Smoking) is a popular, free third party mobile application aimed at helping smokers quit smoking. This is the mobile app that will serve as the control condition in evaluating the efficacy of Impacto. This mobile app is well established as a smoking cessation app for Spanish-speaking, Latinx smokers. The app includes smoking cessation components but does not have a specific emphasis on anxiety sensitivity.
15804114|NCT04417062|Drug|Olaparib|Olaparib is taken by mouth, twice daily through out the 28 day study cycle.
15804115|NCT04417062|Drug|Ceralasertib|Ceralasertib is taken by mouth, once daily on days 1-7 of the study cycle.
15804116|NCT04417049|Drug|Pentoxifylline 400 MG|All patients will be provided with pentoxifylline 400 mg to be orally ingested twice daily for 8 weeks.
15804117|NCT04417036|Drug|BAY1097761 Active Dose 1|Participants will receive a lower dose ADM by inhalation
15804118|NCT04417036|Other|Placebo to BAY1097761|Participants will receive Placebo to BAY1097761 by inhalation
15804119|NCT04417036|Drug|BAY1097761 Active Dose 2|Participants will receive a higher dose ADM by inhalation
15804120|NCT04417023|Other|B3 for NMD: Bench to Bedside and Back|Transformative discoveries leading to improved care in Neuromuscular Disease
15804121|NCT04417010|Procedure|Radiofrequency ablation|Both groups of patients underwent radiofrequency ablation
15804122|NCT04416997|Procedure|Blood and serum samples|The blood and serum samples will taken from RA patients
15804123|NCT04416984|Genetic|ALLO-501A|ALLO-501A is an allogeneic CAR T cell therapy targeting CD19
15804124|NCT04416984|Biological|ALLO-647|ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
15804125|NCT04416984|Drug|Fludarabine|Chemotherapy for lymphodepletion
15804126|NCT04416984|Drug|Cyclophosphamide|Chemotherapy for lymphodepletion
15805522|NCT04405206|Procedure|Local excision|For ymriT1N0 and near-cCR patients，LE is optional.
15804128|NCT04416958|Device|cardiac implantable electronic device (CIED) implantation|CIED Implantation according to the Guidelines aiming to avoid pacing induced dyssynchrony
15804129|NCT04416945|Other|Household Reactive Case Detection|Within 7 days of the index case notification, all members of the index case's household and everyone in the neighboring five households will then be invited to participate in the study. After consenting, a finger stick blood sample will be collected for each consenting individual for testing with the HS-RDT for P. falciparum, a standard combination RDT, and four blood spots on filter paper.
15804130|NCT04416945|Other|RACD of cases' co-workers/co-travelers|"Index cases will be screened by the VMW at their households at the time of case investigation to determine if they have traveled or worked in a forest or forest-fringe area within the past 30 days. If eligible, the case will trigger two reactive recruitment strategies to screen and treat others who recently traveled or worked with the case in a forest or forest-fringe location:
~Peer-referral RACD (PR-RACD): In this strategy, the case will identify specific co-travelers or co-workers resident in their village who had spent the night with the case at a forest or forest-fringe area and spent the night there in the past 30 days.
~Venue-based RACD (VB-RACD): In this strategy, co-workers will be recruited directly from (accessible) forest or forest-fringe work sites where the index case worked and spent at least one night in the past 30 days."
15804131|NCT04416945|Other|Case Management and Follow-up|"All individuals who test positive by either HS-RDT or Standard RDT will be told of their results and treated on site per national guidelines:
~Individuals with P. falciparum infection will be treated with an age-appropriate course of artemether-lumefantrine (AL) and a single low dose of primaquine (SLD-PQ). Weight-based dosing is described in Tables 2 and 3 below.
~At all study sites in Lao Peoples Democratic Republic, patients with a P. vivax infection identified by RDT (both febrile and asymptomatic) will be given a unique coded and signed informational letter directing them to the nearest district hospital (or other testing facility) for G6PD deficiency testing and possible radical cure administration depending on results. At the health facility, G6PD normal individuals will be treated with AL and a 14-day course of PQ, whereas G6PD deficient individuals will receive AL alone as per the national guidelines and referred to a hospital for further primaquine management decisions."
15804132|NCT04416932|Procedure|Ultasound|Evaluation of post-operative patients who have had total shoulder arthroplasty and will assess the integrity of the rotator cuff using ultrasound.
15804133|NCT04416919|Other|Assembled mask|Assembled masks consisting of 3 parts: A facemask (Respironics Performax Whole Face Mask or Hans Rudolph mask naso-oral mask) linked by a blue elbow ( RP Performax SE ELBOW) to a ventilator filter (Teleflex Bacterial/Viral filter 1605 or Iso-Gard HEPA light Filter 28022)
15804134|NCT04416906|Drug|Biktarvy|Once daily fixed dose combination regimen of Biktarvy will be evaluated as a rapid treatment strategy in newly HIV diagnosed patients HIV diagnosed patients that come for the first time to the Hospital Clínic HIV Unit
15804135|NCT04416893|Diagnostic Test|RT-PCR SARS-Cov2|nasopharyngeal swab will be taken for detection of SARS-CoV-2 by RT-PCR
15804136|NCT04416893|Diagnostic Test|Sars-Cov2 serology|A microsample of blood will be taken for serology
15804137|NCT04416880|Device|Press Tack Needle Acupuncture|Seirin Pyonex Press Tack Needle 0.20 x 0.60 mm for SI1 Shaoze acupuncture point Seirin Pyonex Press Tack Needle 0.20 x 0.90 mm for CV17 Danzhong acupuncture point
15804138|NCT04416867|Device|splint and home exercise|Each patient will be given a home exercise program of wrist range of motion, wrist stretch, wrist isometric strengthening and median nerve glide exercises to be performed daily for the duration of the study
15804139|NCT04416867|Device|RESWT|RESWT at a pressure of 4 bars, a frequency of 5Hz and 2000 hits in total will be applied 2cm proximal to the median nerve, with the probe directed towards the palm, diffusely over the pisiform.
15804140|NCT04416867|Device|physical therapy|20 minutes of liquid paraffin treatment of the hand, 1.5watt/cm2 therapeutic ultrasound applied to the volar surface of the wrist for 5 minutes and 20 minutes of transcutaneous electrical nerve stimulation (TENS) on five consecutive days of the week for a total of fifteen sessions over 3 weeks
15804141|NCT04416854|Procedure|resection of primary tumor|resection of primary lesion with unresectablely metastatic colon cancer
15804142|NCT04416854|Drug|XELOX|Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle
15804143|NCT04416854|Drug|mFOLFOX6|Oxaliplatin 85mg/m2, leucovorin 400mg/m2 ivgtt d1 and 5-FU 400 mg/m2 IV bolus d1，2400 mg/m2 CIV 46h, d1
15804144|NCT04416841|Behavioral|Tai Chi Chuan|Participants would take 24-form simplified Tai Chi Chuan 1 hour/session, 3sessions/week for 24 weeks. There were 10 minutes warm-up, 40 minutes Tai Chi Chuan lesson and 10 minutes cool-down exercises in the Tai Chi Chuan training. Besides, they would also take standard diabetic care education 0.5hour/session, 2 sessions/month for 6 months.
15804145|NCT04416841|Behavioral|Fitness Walking|Participants would take fitness walking training 1 hour/session, 3sessions/week for 24 weeks. There were 10 minutes warm-up, 40 minutes fitness walking and 10 minutes cool-down exercises in the fitness walking training, the exercise intensity was 50% to 70% of the maximum heart rate. Besides, they would also take standard diabetic care education 0.5hour/session, 2 sessions/month for 6 months.
15804146|NCT04416841|Behavioral|Standard Diabetic Care Education|Participants would take standard diabetic care education 0.5hour/session, 2 sessions/month for 6 months.
15804147|NCT04416828|Device|Portable wireless ultrasonography device|Patients with suspected ganglion cyst of the wrist or hand receive portable wireless ultrasound imaging
15804148|NCT04416828|Device|Cart-based ultrasonography device|Patients with suspected ganglion cyst of the wrist or hand receive conventional cart-based ultrasound imaging
15804149|NCT04416815|Other|Integrating Health promotion with and for Older People - eHealth|The intervention will be delivered for 6 months on top of usual care. It will be provided by HCPs. If needed one home visit to install the digital platform will be conducted. A HCP will introduce how to use the digital platform and create a personal account. The intervention starts with a person-centred phone-call where a health plan is co-created and potential team members to support this are identified and invited. The health plan includes the older persons' goals, internal and external resources, and need of support from health and/or social-services. This plan will be the point of departure for the forthcoming dialogue. A digital platform will open up for extended and safe communication and visualize the health planning between the older person and team-members in different settings. The older person and the HCP and involved team members on the digital platform will regularly evaluate the health plan and commonly agreed goals.
15804150|NCT04416802|Combination Product|autologous platelet-rich plasma and low-intensity extracorporeal shockwave therapy|"The patient who encounters sexual dysfunction and visits our Outpatient Department (OPD) could enter this trial if he meets the inclusion criteria and exclusion criteria.
~To fill the questionnaires of International index of erectile function (IIEF) and erectile hardness score (EHS) before starting treatment.
~Li-ESWT treatment weekly for three weeks and PRP injection at the same day after the last Li-ESWT treatment.
~Coming back at the fourth week and check is there any side effect and fill the questionnaires of IIEF and EHS.
~Li-ESWT treatment weekly for three weeks starts on fifth week and PRP injection at the same day after the last Li-ESWT treatment.
~Coming back at the eighth week and check is there any side effect and fill the questionnaires of IIEF and EHS.
~Coming back at the twelfth week and check is there any side effect and fill the questionnaires of IIEF and EHS."
15804151|NCT04416789|Other|Exercise programme|1 session of trampolining/dry sports (1.5 hours) and 1 session of supervised swimming (1.5 hours) per week for 10 weeks.
15804152|NCT04416776|Drug|Strabismus diagnostic system.|An AI platform based on corneal light-reflection photos to facilitate the diagnosis and angle evaluation of strabismus and to provide advice for surgical planning.
15804153|NCT04416750|Drug|Imatinib Mesylate|Treatment with Imatinib
15804154|NCT04416737|Other|Ultra-rapid insulin|Following 3 hours of insulin suspension from insulin pump, participants will receive insulin injection in respective locations (separated by at least 1 week) and then have serial lab measurements (YSI glucose, insulin and glucagon) taken during induced hypoglycemia.
15804155|NCT04416724|Procedure|Phacoemulsification|Lens removal by Phacoemulsification
15804156|NCT04416724|Device|Selective Laser Trabeculoplasty|Laser application in trabecular meshwork
15804157|NCT04416711|Behavioral|Personalized Feedback|The personalized feedback consists of four components: normative feedback, risk/protective feedback, decisional balance/goal setting, and protective strategy review. Personalized feedback targets include readiness to change, perceptions of risk, and misperceptions of peer attitudes/behaviors.
15804158|NCT04416711|Behavioral|Cognitive Skills Training|We will address three cognitive targets: focus on affective cues, focus on non-affective cues, and over-perception of sexual interest. The first module targets enhanced focus on women's affective cues and reduced over-perception of sexual interest. We will introduce the role of men's sexual-perception skills in satisfying social and sexual interactions with women, as well as problematic sexual behavior including RSB and SAB. Next, we will instruct participants that affective information is the best-available nonverbal information about how a woman is feeling about a specific man. This instruction will focus on distinguishing four primary dating relevant cues: sexual-interest, friendliness, sadness, and rejection. More detailed focus on each cue will emphasize the increased difficulty of reading these cues with a new partner and under the influence of alcohol and sexual arousal, as well as the importance of checking verbally on assumptions about a woman's current sexual interest.
15804159|NCT04416711|Other|Services As Usual|These participants will receive services as usual
15804160|NCT04416698|Behavioral|Individual qualitative interview|Individual interviews will be conducted to understanding the needs and concerns of youth smokers of e-cigarette or other new tobacco products, including their risk perceptions, and the behaviour, attitudes, and experiences related to these tobacco products.
15804161|NCT04416698|Behavioral|cross-sectional survey study|structured questionnaire will be constructed for a cross-sectional survey to further explore the behaviour, attitudes, and experiences related to electronic cigarettes or other new tobacco products among youth.
15804162|NCT04416685|Procedure|primary repair|For Level I-II tumors, in case of segmental resection of PV/SMV, the reconstruction was performed by an end-to-end anastomosis either by direct suture (for defect under 2 cm) or by using an interposition venous or prosthetic graft. For this purpose, autologous grafting we used internal jugular vein and cadaveric iliac vein and alternatively, synthetic PTFE graft was also used.
15804163|NCT04416685|Procedure|segmental resection|For Level I-II tumors, in case of segmental resection of PV/SMV, the reconstruction was performed by an end-to-end anastomosis either by direct suture (for defect under 2 cm) or by using an interposition venous or prosthetic graft. For this purpose, autologous grafting we used internal jugular vein and cadaveric iliac vein and alternatively, synthetic PTFE graft was also used.
15804164|NCT04416685|Procedure|graft reconstruction|Regarding Level III tumors, complete resection of the tumor was done either by tangential excision or by partial venous excision and subsequent reconstruction. To maintain a secure anastomosis, the mesenteric root was mobilized completely or/and splenic vein was divided.
15804165|NCT04416672|Other|PRO-CTCAE items|"Enrolled patients will be asked to complete a subset of the PRO-CTCAE items based on cancer type, and the following instruments used as anchors to measure psychometric properties:
~the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life disease-specific module, if a linguistically validated Italian version exists, or the General QLQ-C30, if the Italian version is not available.
~the Hospital Anxiety and Depression Scale (HADS)
~The Patients' Global Impression of Change (PGIC) Scale."
15804166|NCT04416659|Device|Neuro-vascular access|Adjunctive device providing a conduit for retrieval device during thrombectomy
15804167|NCT04416646|Drug|Cabozantinib|The regimen will be a single oral dose administered daily on a continuous schedule, taken with or without food. The standard dose is 60 mg per day, which can be reduced to 40 or 20 mg according to the latest version of the Summary of Product Characteristics-SPC available. The treating oncologist will evaluate the opportunity to prudentially start treatment at 40 mg/daily in patients screening positively at G8 screening tool, and then escalate to 60 mg/daily only in case of absence of toxicity ³grade 2 at subsequent cycles. Temporary suspensions of treatment are allowed according to the local practice and will be registered if ³ 7 days.
15804168|NCT04416633|Drug|Durvalumab|500-mg/120-mg IV
15804195|NCT04416321|Device|Surgery with the Keos Lumbar Interbody Fusion Device|All subjects will received the Keos Lumbar Interbody Fusion Device if according to the investigators opinion they are clinically indicated to have surgery treatment for degenerative disc disease, spondylolisthesis and retrolisthesis
15804196|NCT04416308|Diagnostic Test|NG test|rapid diagnosis Covid 19
15804197|NCT04416308|Diagnostic Test|Blood test|sample
15804198|NCT04416308|Behavioral|Self-questionnary|behavioral survey
15804252|NCT04415879|Device|Cloth Face Mask|A cloth mask will be worn as personal protective equipment during a graded exercise test
15804253|NCT04415879|Diagnostic Test|Graded exercise test|No personal protective equipment during a graded exercise test
15804169|NCT04416620|Other|The PCOS pharmaceutical care service|"The intervention was provided in the format of oral plus written information. The information provided included the importance of exercise and motivational messages to exercise more at home or in the gym.
~The 2nd part was about the importance of decreasing the stress levels. Participants were informed to perform a simple breathing exercise on daily basis twice a day.
~The 3rd part aimed at improving participants' diets. They were informed to follow specific diet recommendations and to avoid certain types of food, explaining to them how it may negatively affect their PCOS condition.
~The 4th part was about the PCOS treatment that was discussed with the participants. Females were advised on the importance of using their correct treatment. They were informed of the importance of adhering to their prescribed medications, accepting that it was a long-term treatment plan, and to consult with their specialist if their treatment was not effective, or in the case of medication side effects."
15804170|NCT04416607|Drug|Corifollitropin Alfa|Primary outcome measure is ovarian response measured by FORT. Drugs are administrated for controlled ovarian stimulation prior in vitro fertilization.
15804171|NCT04416607|Drug|Menotropins|Primary outcome measure is ovarian response measured by FORT. Drugs are administrated for controlled ovarian stimulation prior in vitro fertilization.
15804172|NCT04416594|Other|Data collection|Only data collection
15804173|NCT04416581|Drug|PPI|rabeprazole 20mg + tegoprazan 50 mg placebo + tegoprazan 25 mg placebo, once daily.
15804174|NCT04416581|Drug|P-CAB 25|tegoprazan 25 mg + rabeprazole 20mg placebo + tegoprazan 50 mg placebo, once daily.
15804175|NCT04416581|Drug|P-CAB 50|tegoprazan 50 mg + rabeprazole 20mg placebo + tegoprazan 25 mg placebo, once daily.
15804176|NCT04416568|Drug|Nivolumab|"Combination Therapy: Nivolumab at predetermined dosage day 1 of a 21-day cycle for 4 cycles.
~Monotherapy: Starting with cycle 5 nivolumab at predetermined dosage on day 1 and day 15 of a 28-day cycle"
15804177|NCT04416568|Drug|Ipilimumab|Combination Therapy: Ipilimumab at predetermined dosage day 1 of a 21-day cycle for 4 cycles
15804178|NCT04416555|Device|Placebo comparator: VR googles and the non reality experience|parallel assignment (this arm will receive a static presentation in the same device)
15804179|NCT04416555|Device|Active Comparator: VR googles and the real VR program to enter act with and experience|Parallel assignment (this arm will receive the full immersive virtual reality experience
15804180|NCT04416542|Diagnostic Test|Home Sleep Testing|"Two-night Home Sleep Tests (HSTs) will be conducted using commercially available Home Sleep Test equipment. The HST will be ordered by the clinical center through a HIPAA compliant HST service that has been selected by the study sponsor.
~The HSTs will be scored and interpreted according to AASM Guidelines by board certified sleep physicians affiliated with the HST service. The HST will be scored using the 4% oxygen desaturation rule."
15804181|NCT04416529|Behavioral|Tele-MBCT|Please see arm/group description.
15804182|NCT04416516|Biological|ASN-002|ASN-002 has been designed for clinical applications, especially for intratumoral administration in the treatment of various cancers. This rAd vector delivers the gene of interest, in the case of ASN-002 the human IFNγ gene, into target cells. The rAd vector in ASN-002 is replication deficient and although it infects cells, it is not able to replicate in the tumor or in normal human cells. The infected cells are able to transcribe and translate the IFNγ DNA leading to a sustained local concentration of IFNγ in the tumor mass that is designed to avoid high levels of systemic IFNγ that may be lead to unacceptable toxicity.
15804183|NCT04416503|Other|Foot reflexology|Foot reflexology was performed for 12 week in the study group,whereas the control group continued their routine treatment and follow-up.
15804184|NCT04416464|Other|COVID-19 Pneumonia|Pneumonia due to proven or suspected SARS-Cov-2 infection
15804185|NCT04416451|Drug|Rituximab|Induction:Rituximab will be administered per institutional guidelines once per week for 4 weeks at a dose of 375 mg/m^2. Maintenance: In addition, patients will receive rituximab 375 mg/m2 starting on day 1 of the maintenance phase and repeated once every 3 months for 12 months (for a total of 4 infusions). On days when venetoclax and rituximab will both be administered, patients will take venetoclax prior to administration of rituximab.
15804186|NCT04416451|Drug|Venetoclax|"Induction: Starting one week after the last induction dose of rituximab (approximately week 5), venetoclax will be administered orally at a flat dose of 100 mg daily and escalating each week to a target dose of 800 mg daily on the following schedule:
~Week 1: 100 mg
~Week 2: 200 mg
~Week 3: 400 mg
~Week 4: 800 mg Maintenance: Following the 4-week induction phase ramp-up of venetoclax, patients will begin their target dose of 800 mg venetoclax daily and continue this dose during the 24- month maintenance treatment phase. On days when venetoclax and rituximab will both be administered, patients will take venetoclax prior to administration of rituximab."
15804187|NCT04416412|Other|Immunofluorescence Imaging|Patients will be administered FDA approved ICG through intravenous injection and imaged by a FDA approved surgical microscope (Spy Elite) which is 0.5 meter away from the subject. Both ICG fluorescence and the two imaging systems have been used for routine clinical practice for many years. Figure (a) shows the Schematic sketch of the imaging systems. ICG fluorescence imaging utilizes intravenously injected ICG, which is a fluorescent dye that is FDA-approved for clinical use, illuminated with near-infrared light. The ICG dye is indirectly activated and the dynamic fluorescence due to bone perfusion can be captured by a video rate imaging system.
15804188|NCT04416399|Drug|Budesonide dry powder inhaler|Budesonide inhaled via dry powder inhaler, 400 micrograms per inhalation, 2 inhalations twice a day
15804189|NCT04416386|Other|Vitamin C|Pre and post-operative blood plasma levels of vitamin C will be investigated
15804190|NCT04416373|Diagnostic Test|RT PCR SARS-CoV-2|Positive SARS-CoV-2 RT PCR in nasopharyngeal/oral swab tests or presence of IgM in blood samples
15804191|NCT04416360|Other|Interview by psychologists|"Interviews for children / teenagers and parents :
~The questions encourage a narrative
~Repeated interviews: during confinement, at the end of confinement, and 3 months after the end of confinement
~Interviews carried out by videoconference, by trained psychologists not involved in the care process
~Interview for referring caregivers: a single interview of approximately 45 minutes, 3 months post-confinement"
15804192|NCT04416347|Other|SARS-CoV2 Infection|Laboratory confirmed SARS-CoV2
15804193|NCT04416334|Drug|Colchicine plus symptomatic treatment (paracetamol)|Colchicine plus symptomatic treatment (paracetamol).
15804194|NCT04416334|Drug|Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations)|Symptomatic treatment (paracetamol or best symptomatic treatment based on doctor recommendations).
15804199|NCT04416295|Device|LifePod|LifePod consists of a Web-based E-Health platform with two interfaces, one medical for healthcare professionals and one patient interface. LifePod is accessed via a smartphone, tablets and computers via a web application where patients enter symptom parameters and vital parameters such as breathing and mucus status, weight, activity, medication or other disease-specific values. Several different validated questionnaires are sent regularly to the patient to obtain information about the patient's mood and activity. The platform contains a chat function between healthcare professionals and patients. A unique health profile is created in which the patient self-reports their health. The patient receives direct feedback in their web application if they are within the interval given for the individual. The medical interfaces are designed so that patients are automatically placed in a priority order where the person outside the given range is given top priority.
15804200|NCT04416282|Drug|Terlipressin|Injection terlipressin 2 mg/24 hours infusion
15804201|NCT04416282|Biological|Albumin|i/v albumin 1g/Kg/day
15804202|NCT04416269|Drug|Oral Anti-diabetes Drugs alone|OADs will be continued at same outpatient dosage unless contraindicated. Participants will be switched to the preferred drug within the category of medication they take at home. Dose adjustment for OADs will be based on clinical/laboratory status. The OAD will be held if the participant is placed on strict nil per os (NPO) and is unable to take oral medications after enrollment.
15804203|NCT04416269|Drug|Basal bolus insulin|Basal insulin with glargine or detemir will be used as per the hospital formulary.
15804204|NCT04416269|Drug|Supplemental insulin|Supplemental (correction) lispro or aspart insulin following the supplemental/sliding scale standard of care protocol for BG >140 mg/dl.
15804205|NCT04416269|Device|Continuous glucose monitoring (CGM)|"A subset of participants (50 per study arm) will be randomized to take part in an optional study where a CGM devise will be placed for the duration of the study. CGM reports will be reviewed at the end of the study to assess parameters of glycemic control and hypoglycemia, and not used for insulin dose adjustment.
~The FreeStyle Libre Pro Flash Glucose Monitoring System is a professional continuous glucose monitoring (CGM) device. It has three main parts: a handheld reader, a disposable sensor, and FreeStyle Libre Pro software. The sensor has a small,flexible tip that is inserted just under the skin on the back of the patient's upper arm. The sensor can be worn for up to 14 days."
15804206|NCT04416243|Behavioral|Recumbent Stepping, High-Intensity Interval Training|"The intervention will involve 12 weeks of supervised, progressive (i.e., intensity increases after midpoint testing based on reassessment of aerobic fitness) HIIT sessions two to three times per week. HIIT exercise sessions will be manualized and led by exercise leaders. Secondary outcomes testing will occur at baseline (week 0), midpoint (following week 6 of training), and post-intervention (following week 12 of training).
~The individual HIIT sessions will involve 10 cycles of 60s intervals at the wattage associated with 90% VO2peak followed by 60s of active recovery intervals at 15 watts, totaling 20 min in length. All exercise sessions will begin and end with a 5-minute warm-up and cool-down, respectively. Required power output for each interval of the exercise session will be individualized and completely automated. VO2peak from baseline and midpoint testing will be used to determine exercise intensity for weeks 1-6 and weeks 7-12, respectively."
15804207|NCT04416230|Behavioral|massage|The massage included 30 minutes of gentle friction, kneading, stroking, and passive touch on the infant's accessible upper extremities, lower extremities, head, face, and back.
15804208|NCT04416230|Behavioral|quiet time|During quiet time, the infant received a 30 minute quiet time (QT) period during which non-essential caregiving tasks were restricted. During QT, clinicians were asked to avoid direct clinical caregiving activities, i.e. activities requiring physical contact with the infant.
15804209|NCT04416204|Other|High Carbohydrate (glycogen loading)|Subjects will consume an isocaloric diet [60% carbs, 20% protein, 20% fat (33 kcal/kg/day)] for 3 days prior to the overnight study.
15804210|NCT04416204|Other|Low carbohydrate (No Glycogen Loading)|Subjects will consume an isocaloric diet [40% carbs, 20% protein, 40% fat (33 kcal/kg/day)] for 3 days prior to the overnight study.
15804211|NCT04416191|Device|Limb immobilization|Participants will undergo a 2-week period of leg immobilization
15804212|NCT04416165|Diagnostic Test|18F-FDG and 68Ga-DOTA-FAPI -04 PET/CT|Each subject receive a single intravenous injection of 18F-FDG and 68Ga-DOTA-FAPI-04, and undergo PET/CT imaging within the specified time.
15804213|NCT04416152|Procedure|Pelvic reconstruction surgery|Pelvic reconstruction surgeries, such as anterior/posterior colporrhaphy, sacrospinous ligament fixation, transvaginal mesh repair and sacrocolpopexy.
15804214|NCT04416139|Biological|Infusion IV of Mesenchymal Stem cells|Mesenchymal Stem cells from bank will be applied IV, at dose 1 million xKg in a single dose
15804215|NCT04416126|Biological|ARCT-810|ARCT-810 is an investigational medicinal product comprising OTC mRNA formulated in a lipid nanoparticle (LNP) under development.
15804216|NCT04416126|Other|Placebo|The placebo for this study is 0.9% sterile saline.
15804217|NCT04416113|Procedure|photobiomodulation and photodynamic therapy|antiviral treatment
15804218|NCT04416100|Diagnostic Test|Pulmonary function tests|Spirometry or plethysmography, measurement of diffusion capacity
15804219|NCT04416100|Diagnostic Test|Imaging|HRCT and echocardiography as scheduled within routine clinical examinations
15804220|NCT04416100|Biological|Blood sampling|Standard laboratory test as part of routine clinical examination and collection of peripheral blood for immunofibrotic phenotyping
15804221|NCT04416087|Other|Exercise|Positron emission tomography (PET) imaging at rest and during supine bicycle exercise Tumor blood flow and its heterogeneity will be measured with PET at rest and during supine bicycle exercise.
15804222|NCT04416074|Behavioral|An online 5-week professional identity group psychotherapy|This is an online 5-week group psychological intervention for the nursing students during clinical rotation practice. It aims at promoting the professional identity and career sefl-efficacy for them. There are five sessions in the intervention, and each session lasts from 60min to 90min at each week. The intervention will be delivered via an online meeting software, like Zoom. There will be 15-20 students in one meeting group.
15804223|NCT04416074|Other|Message push|Controlled group will receive online messages of self-care knowledge forward by researchers once per week. The knowledge contain stress regulation, strategies for relaxation, self-protection during clinical practice.
15804224|NCT04416061|Diagnostic Test|COVID 19 Diagnostic Test|COVID 19 Diagnostic Test
15804250|NCT04415892|Other|Cinnamaldehyde and capsaicin|Topical application of cinnamaldehyde and capsaicin on the fingers
15804225|NCT04416048|Drug|Rivaroxaban|Treatment with Rivaroxaban 20 mg (15 mg for subjects with an eGFR ≥30 mL/min/1.73m2 and <50 mL/min/1.73m2) once daily (OD) for at least 7 days. In case of hospitalization for more than 7 days, the therapeutic treatment with rivaroxaban will be continued for the duration of the hospital stay until discharge. After at least 7 days of therapeutic treatment with rivaroxaban or after hospital discharge, the study dose of rivaroxaban will be adjusted as follows. Patients randomized to the rivaroxaban study arm will reduce daily dosage to 10 mg OD, provided that they were not diagnosed with a condition requiring continued therapeutic anticoagulation. Thromboprophylaxis therapy will be given for 28 days up to day 35 post randomization or even longer. If the patient cannot be discharged from the hospital prior to day 35 post randomization, the thromboprophylaxis phase will also start upon hospital discharge, but is then shorter than 28 days, because the study ends at day 60 post randomization.
15804226|NCT04416048|Other|Standard Of Care (SOC)|Standard of care treatment
15804227|NCT04416035|Biological|TRS003|TRS003 will be administered at 15 mg/kg by IV infusion on Day 1 of each cycle (every 3 weeks, Q3W). Each cycle is 3 weeks.
15804228|NCT04416035|Biological|China-approved Bevacizumab|China-approved bevacizumab will be administered at 15 mg/kg by IV infusion on Day 1 of each cycle (every 3 weeks, Q3W).Each cycle is 3 weeks.
15804229|NCT04416035|Drug|Carboplatin|Carboplatin will be administered at an AUC 6 mg/mL/ min (the maximum dose capped at 900 mg) by IV infusion (over 15 - 30 minutes) Q3W on Day 1 of each cycle.
15804230|NCT04416035|Drug|Paclitaxel|Paclitaxel will be administered at a dose of 200 mg/m^2 by IV infusion (over 3 hours) Q3W on Day 1 of each cycle
15804231|NCT04416022|Diagnostic Test|Ultrasound examination|Women that are planned for labour induction, will undergo a routine ultrasound examination prior to the initiation of the induction process.
15804232|NCT04416009|Device|NİCaS|whole body bioimpedence method
15804233|NCT04415996|Other|HVLA L3/4|"The participant will be lateral decubitus and the investigator will locate the third lumbar vertebra. Then with one hand the investigator will contact the interspinous space underlying L3 and with the other hand he will take the top leg into flexion until the investigator feels tension in L3/L4 joint. Then he puls the tables´s arm until felling tension in the region to be manipulated. Afterwards the investigator will globally rotate the participant in the horizontal plane and will approach to the L3/L4 joint. With one arm the investigator will contact the deltopectoral groove and with the other one will contact the external iliac fossa. Finally, the investigator will compress and rotate the pelvis and will apply an impulse in a rapid rotation, without losing the parameters with a body drop allowed by the flexion of the knees and the contraction of the large pectorals."
15804234|NCT04415996|Other|Sham|The participant will be in lateral decubitus and the top leg and knee will be flexed until the foot reaches the popliteal region of the other leg. There won't be applied any tension in no structure. This intervention will be applied during 90 seconds each side.
15804235|NCT04415983|Drug|Nitazoxanide|Nitazoxanide twice daily
15804236|NCT04415983|Drug|Clarithromycin|Klacid twice daily
15804237|NCT04415983|Drug|Metronidazole|Metronidazole twice daily
15804238|NCT04415983|Drug|Proton pump inhibitor|Omeprazoe twice daily
15804239|NCT04415970|Other|Flotation therapy sensory deprivation tank|Participants will float for 60 minutes, 2 times a week for 8 consecutive weeks or alternate with sleep pod every 2 weeks for 8 weeks. All participants will wear a fitness tracker and a sleep monitoring ring worn on the finger for the duration of the study. Each session will be preceded by a short safety questionnaire and an anxiety index. Following each session, the participant will complete the index again. Participants will also complete morning and evening questionnaires and monthly questionnaires on a smartphone.
15804240|NCT04415970|Other|Sleep Pod|Participants will utilize the sleep pod for 60 minutes, 2 times a week for 8 consecutive weeks or alternate with float every 2 weeks for 8 weeks. All participants will wear a fitness tracker and a sleep monitoring ring worn on the finger for the duration of the study. Each session will be preceded by a short anxiety index. Following each session, the participant will complete the index again. Participants will also complete morning and evening questionnaires and monthly questionnaires on a smartphone.
15804241|NCT04415957|Other|Elastic Tape|The patient's trunk will be passively extended before the application. The ET will be placed in the thoracoabdominal region to reduce thoracoabdominal asynchrony and to improve the volume distribution between the thoracic and abdominal compartments. The placement will bey the origins and insertions of the following muscle groups: rectus abdominis, internal oblique, and intercostal. The individuals will receive the ET after baseline evaluations and will remain with them for 1 week, when they will return to replace the ET, totalizing 2 weeks of intervention.
15804242|NCT04415944|Procedure|Second look laparoscopy reassessment surgery (SLLRS)|Performed less than 12 weeks after intravenous chemotherapy cycles are completed.
15804243|NCT04415944|Drug|HIPEC with Carboplatin|"Patient receives HIPEC with CBDCA 800 mg/m2 for 90 minutes.
~Patients who exhibit the following will not receive the HIPEC procedure:
~Extraperitoneal disease noted at the time of the second look procedure
~Macroscopic intraperitoneal disease which is not resectable to R1
~Technical problems which prevent continuous, adequate flow to maintain intraperitoneal temperature to 41°C during perfusion
~Intraoperative complications such as cardiac or pulmonary instability precluding HIPEC
~Participation will consist of completing surveys regarding their cancer and allowing researchers to use information from their medical records for research."
15804244|NCT04415944|Other|FACT-O Quality of Life Questionnaire|Participants will be asked to do this three times (pre-study, 3 months and 6 months). Surveys will be given at follow up visits for surgery. They should take about 10-15 minutes to complete.
15804245|NCT04415931|Procedure|Local infiltration analgesia|"Local infiltration injection intraoperatively prior to closing during the procedure. A standardized dose of 100 mL of infiltration will be utilized according to the following formula. The mixture will be injected into the deltoid and pectoralis major muscles and fasciae, and subcutaneous tissues using an 18-guage needle.
~Total dose 100mL
~Ropivacaine 0.5% 40mL Epinephrine 1mg/mL 0.1mL Ketorolac 30mg/mL 1mL Morphine 10mg/mL 0.5mL Normal saline 0.9% 58.4mL"
15804246|NCT04415931|Procedure|Interscalene block|Standard interscalene brachial plexus regional block
15804247|NCT04415918|Drug|Bezlotoxumab Injection|A single dose of Bezlotoxumab (Zinplava) 10mg/kg (actual body weight) 60-minute intravenous infusion during active CDI treatments.
15804248|NCT04415905|Drug|Propofol|The participants in the group P are anesthetized with propofol
15804249|NCT04415905|Drug|Sevoflurane|The participants in the group S are anesthetized with sevoflurane.
15804254|NCT04415866|Behavioral|Paced Auditory Serial Addition task (PASAT)|Single and double digits are presented at intervals between 2 and 3 seconds and the participant must add each new digit to the one immediately prior to it. The participants will be asked to indicate by electronic button press whether the sum of the addition is 13 or not. The duration of the PASAT will be two 12-min tasks.
15804255|NCT04415853|Drug|Lerotinib|Specification: 50 mg/capsule and 150 mg/capsule
15804256|NCT04415853|Drug|Irinotecan/Tegafur|Irinotecan:Specification: 2mL: 40mg;5mL:0.1g Tegafur:20mg/capsule
15804257|NCT04415840|Diagnostic Test|acetic acid test|using acetic acid to unmask dysplastic lesions on the cervix uteri
15804258|NCT04415840|Diagnostic Test|Lugol's solution test|using Lugol's solution after acetic acid test to unmask dysplastic lesions on the cervix uteri
15804259|NCT04415827|Diagnostic Test|bicycle ergometry test with spiroergometry|"The 1st testing will be carried out on the 28-31th day of the disease, which corresponds to the period of the expected normalization of temperature, improvement of well-being, positive dynamics of radiological (with community-acquired pneumonia) and laboratory data, the 2nd test - after 3 months, the 3rd - after 6 months and IV - after 12 months.
~Load testing will be carried out on a bicycle ergometer with an initial power of 25 watts with a further increase of 25 watts every 3 minutes. The cessation of the load will be carried out upon the appearance of signs set forth in the recommendations of the World Health Organization Expert Committee (1970)"
15804260|NCT04415814|Procedure|Unilateral Pedicle Screw Fixation|Pedicle screws are installed unilaterally on the one side of the vertebrae and fixed with rod
15804261|NCT04415814|Procedure|Bilateral Pedicle Screw Fixation|Pedicle screws are installed bilaterally on the both sides of the vertebrae and fixed with rods
15804262|NCT04415801|Diagnostic Test|Repeated removal and re-placement of healing and prosthetic abutments|Repeated removal and re-placement of healing and prosthetic abutments
15804263|NCT04415788|Device|Test of Incremental Respiratory Endurance - IMT|The TIRE training regimen will involve the use of a tablet provided to assigned subjects with the training software installed and a PrO2® device through which they will train. The software allows subjects to track their inspiratory muscle performance via real-time graphic representations of their efforts as training progresses.
15804264|NCT04415788|Device|Threshold - IMT|The Threshold incorporates a flow-independent one-way valve to ensure consistent resistance and features an adjustable specific pressure setting to be set based on MIP values of each subject.
15804265|NCT04415788|Device|Sham IMT (Low resistence)|The Threshold incorporates a flow-independent one-way valve to ensure consistent resistance and features an adjustable specific pressure setting to be set based on MIP values of each subject.
15804266|NCT04415775|Other|Game based treadmill Program|Participants will be expected to play several cognitive computer games while standing on a sponge pad (10-min warm-up and while walking on the treadmill at your self-selected comfortable speed. (Dual-task treadmill training). This would be done in intervals of 2-4 min with rest periods for a total time of 35 minutes Treadmill speed and the difficulty level of the cognitive games will progress depending on participant performance and comfort level.
15804267|NCT04415775|Other|Conventional Gait Rehabilitation|Participants will undergo a mixture of current gait training programs available for people with Parkinson's Disease. The protocol will be a Warm-up exercise consisting of rhythmical large movements (10 minutes), as well as video game practice while standing (i.e., single-task; 10 minutes). Treadmill walking in intervals of 2-4 minutes with rest periods. Walking over the ground while negotiating through obstacles. (10 minutes) The speed of the treadmill will be progressed gradually and as tolerated.
15804268|NCT04415749|Biological|NasoShield|NasoShield is an adenovirus-vectored anthrax vaccine
15804269|NCT04415749|Other|Placebo|Normal saline
15804270|NCT04415736|Other|No intervention, observational study|
15804271|NCT04415723|Other|supportive care management programme|nurse-led management programme
15804272|NCT04415697|Diagnostic Test|Gene expression test using nanostring technology.|Evaluation of gene expression profile of a panel with 770 genes related to disease progression using nanostring technology
15804273|NCT04415684|Device|Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)|For the right/test eye, a defocused image is projected onto the peripheral retina while the subject views a distant, in-focus image
15804274|NCT04415684|Device|No Active projection of defocused image in the peripheral visual field (eSpecs, Acucela Inc.)|For the left/control eye, no image is projected onto the peripheral retina. The subject views a distant, in-focus image.
15804275|NCT04415671|Biological|AD-214|AD-214 is a recombinant Fc-fusion protein that selectively binds to CXCR4 to antagonise the SDF-1/CXCR4 axis.
15804276|NCT04415671|Other|Placebo|Placebo
15804277|NCT04415658|Drug|Thyroxine|Infusion prepared by mixing 500 μg of drug in 500-ml of normal saline (i.e. concentration of 1 μg/ml) and enclosing the bag in an opaque sleeve. Infusion started at 30 μg/hour (30 ml/hour) for twelve hours.
15804278|NCT04415658|Drug|Saline|The placebo will be a 500-ml bag of normal saline (without active drug) also enclosed in an opaque sleeve. This infusion will also be started at 30 ml/hour for twelve hours.
15804279|NCT04415645|Drug|[14C]-VVZ-149|A single IV infusion of radio-labeled VVZ-149
15804280|NCT04415632|Other|low glycemic index diet|• Three-day cycle menu of LGI diet will be designed and supplied to each participant in an amount designed to meet their estimated energy requirements. The percentage energy from protein, fat and carbohydrate will be the same in the two diets. Each diet period of the trial will last for two weeks.
15804281|NCT04415632|Other|High glycemic index diet|Three-day cycle menu of HGI diet will be designed and supplied to each participant in an amount designed to meet their estimated energy requirements. The percentage energy from protein, fat and carbohydrate will be the same in the two diets. Each diet period of the trial will last for two weeks.
15804282|NCT04415619|Procedure|Xenograft bone substitute (Osteo-biol)|Xenograft bone substitute will be placed over the implant to cover the bone defect after extraction.
15804283|NCT04415606|Device|QuikClot Control+|Non-absorbable, sterile, X-ray detectable non-woven dressing impregnated with kaolin.
15804284|NCT04415593|Dietary Supplement|High dose of peanuts|Patients will receive a high dose of ground peanuts (300 mg) mixed with apple mousse (supposing child tolerates apple). For the transparency of the study all patients will receive the same commercially prepared apple product
15804336|NCT04415138|Device|Robotic-assisted mitral valve repair|Mitral valve repair using robotic technology (DaVinci X platform)
15804285|NCT04415593|Dietary Supplement|Low dose of peanuts|Patients will receive a low dose of ground peanuts (150 mg) mixed with apple mousse (supposing child tolerates apple). For the transparency of the study all patients will receive the same commercially prepared apple product
15804286|NCT04415580|Other|Vestibular Rehabilitation (VR)|"VR consisted of two types of exercises, i.e., those for gaze stability and those for postural stability
~Gaze stability exercises The patients will perform the exercises while holding their gaze on a firm target (VORx1) during active horizontal and vertical head movements (one minute for each axis).
~Postural stability exercises March in Place Each patient will ask to get on a foam cushion of 10 cm in height and then will blindfold. Treadmill Training As preparation for training, all subjects underwent a 1-minute walk on treadmill with open eyes using preferred walking speed. Immediately after preparation, patients will blindfold and will ask to walk on treadmill without support of hands for 4 minutes.
~When patients made the mistake of changing direction, the physiotherapist help them to keep the right position using verbal cues (e.g., you are turning left or right)."
15804287|NCT04415580|Other|Conventional Neurorehabilitation|muscles stretching, active and assisted limbs mobilization, four limbs coordination exercises, balance training on instable platform and gait training
15804288|NCT04415567|Drug|Lenvatinib|The patients in lenvatinib group received oral lenvatinib (Eisai, Japan) 12 mg/day (for bodyweight (BW) ≥60 kg) or 8 mg/day (for BW <60 kg) in 28-day cycles until HCC recurrence or serious adverse events (SAEs) or voluntary withdrawal. Dose interruptions followed by reductions for lenvatinib-related toxicities (to 8 mg and 4 mg/day, or 4 mg every other day) were permitted. All 14 patients took lenvatinib for more than 3 cycles.
15804289|NCT04415554|Diagnostic Test|echocardiography|echocardiography exam of the infant
15804292|NCT04415528|Other|Emotion-Focused Mindfulness Therapy|"EFMT is a group intervention of 8weekly meetings of 2.5 hours with 10 - 12 participants per group. Participants are provided instruction that encourages noting and experiencing bodily sensations and emotions during meditations. Meditations are conducted in silence for between 20 and 35 minutes. Participants are asked to journal their recollection of the meditation and experiences that arise for them as they journal. Each participant then describes their experience in meditation, with the facilitator offering empathic exploration to support transforming negative emotions into adaptive emotions.
~The study will be conducted in an online PHIPPA protected platform and has been modified to accommodate electronic delivery. Maximum number of participants per group will be six, and each session will be 1.5 hours. Data will be collected at three points by a research assistant to evaluate the feasibility of EFMT for older adults and determine whether anxiety is influenced by the intervention."
15804296|NCT04415489|Device|Office hysteroscopy|Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers.
15804297|NCT04415476|Drug|Assigned Interventions|This is a prospective single-center, open-label, randomized, controlled pilot study in the treatment of chronic rejection (CR), defined as grade 1 and 2 BOS, in adult recipients of a pulmonary allograft (single or double lungs). Patients meeting entry criteria shall demonstrate a sustained decline in FEV1 having met stage 1 or 2 BOS. Patients randomized to the study arm, will be treated with Sirolimus (S) orally in place of MMF in addition to tacrolimus and prednisone compared to those patients randomized to defined ST alone (tacrolimus, MMF and prednisone). The trial duration will be approximately 2 years for each subject randomized. Treatment compliance and safety will be monitored by clinic visits at 4-6 week intervals for the 2 year subject duration and will include standard physical examinations and monitoring of routine clinical and laboratory parameters including cause of hospitalizations and rate of adverse events including death in each group. T
15804298|NCT04415463|Device|Multisegmented fully covered self-expandable metal stent|Esophageal FC-SEMS
15804299|NCT04415450|Behavioral|Nutrition Education counseling|In the context of health education program, an educational intervention was developed by the research team based on a training module. The nutrition education contained introductory messages and focused on meanings of healthy diet, eating a variety of food, eating well with the locally available food, hazards of maternal malnutrition, important supplements to be taken during pregnancy, harmful substances to be avoided, and measures of alleviating common discomforts associated with nutrition during pregnancy. The training program was carried out in the form of counseling using printed materials and flip charts for pictorial representation. Self-reading of leaflets containing the core messages for every topic prepared in the native language of the participants was also employed as the women in the study had one each.
15804300|NCT04415424|Biological|4CMenB vaccine|A four-component meningococcal B vaccine
15804301|NCT04415424|Other|Placebo|0.5 ml of 150 mmol sodium chloride (0.9% saline solution)
15804302|NCT04415411|Other|Nursing care based on the Theory of Human Caring|Planned nursing care based on 10 caritas processes of Theory of Human Caring.
15804303|NCT04415398|Device|Automated flying Drone carrying an Automated external defibrillator (AED)|Totally n=3 drones are equipped with automated external defibrillators (AEDs). These drones are deployed by the dispatch centre to cases of suspected out-of-hospital cardiac (OHCA) as a complement to standard care (ambulance/EMS) over 4 months during daytime Monday to Sunday 08:00-22:00. The bystander onsite receives instructions from the dispatcher to retrieve the AED outside the house when it has been delivered by the drone. The bystander attaches the AED to the patients chest to facilitate early defibrillation.
15804304|NCT04415385|Drug|Camrelizumab|200mg, intravenous infusion for 30 minutes (including the time of the tube, the overall infusion time is not shorter than 20 minutes, no longer than 60 minutes), once every 2 weeks.
15804305|NCT04415385|Drug|Apatinib|250 mg, orally once a day. Take about half an hour after a meal with warm water.
15804308|NCT04415346|Biological|HU-014 Inj|Clostridium botulinum type A
15804309|NCT04415333|Drug|Sodium Butyrate 5 mmol|Enema-based delivery of 5 mmol butyrate in 0.9% saline, (60 mL total)
15804310|NCT04415333|Drug|Sodium Butyrate 80 mmol|Enema-based delivery of 80 mmol butyrate in 0.9% saline, (60 mL total)
15804311|NCT04415320|Drug|X-396(Ensartinib)|All consented, enrolled, eligible patients receive X-396 capsules, 225mg once daily.
15804312|NCT04415307|Other|Acupuncture|Acupuncture over acupoints.
15804313|NCT04415307|Other|Far-Infrared heat-patch attachment|Far-Infrared heat-patch attachment over acupoints.
15804314|NCT04415307|Other|Acupuncture and Fir-Infrared heat-patch attachment|Acupuncture and Far-Infrared heat-patch attachment over acupoints.
15804315|NCT04415307|Other|Far-Infrared heat-patch attachment over acupoints without electric current passing.|Far-Infrared heat-patch attachment over acupoints without electric current passing.
15804316|NCT04415294|Diagnostic Test|Critical flicker frequency|Measure the critical flicker frequency as a screening test for hepatic encephalopathy using a portable self administered device
15804317|NCT04415281|Device|THOR® laser system|We chose the THOR® laser system given because their active treatment arm uses both coherent laser and monochromatic LED light. Therefore, we will use three types of active probes in this investigation including, A) Single Laser 810 NM 200 mw; B) Laser Cluster of 810 NM equivalent to 1 WATT and; C) LED Cluster, 34 X 660nm at 10 mw and 35 850nm, 30mw 1390mw total. As detailed in Table 3. We propose to use these three PBM probes in concert for the treatment of TMD pain. Laser A (Single Diode Laser) is designed for isolated trigger points and superficial muscles. Laser B (Cluster Laser) is designed for a more diffuse treatment area,targeting analgesia, anti-inflammatory, and deep tissue repair. Laser C (LED Cluster) is purportedly designed for the presence of diffuse inflammation.
15804318|NCT04415281|Device|sham THOR® laser system|sham THOR® laser system
15804319|NCT04415268|Behavioral|Exercise|Surpervised exercise program: Includes a concurrent exercise intervention (strength training and aerobic training), 3 days a week, 60 minutes sessions.
15804320|NCT04415268|Behavioral|Unsupervised exercise|Unsupervised exercise program: The same exercise program learned during the supervised phase will be practiced at home.
15804321|NCT04415268|Drug|CFTR Modulators|"Standard of care: Lumacaftor with Ivacaftor or Tezacaftor combined with Ivacaftor.
~For children between 6 and 11 years of age, Lumacaftor 400 mg combined with Ivacaftor 500 mg in total per day, divided into 2 doses per day; for those over 11 years of age, Tezacaftor 100 mg combined with Ivacaftor 150 mg in the morning, adding a dose of Ivacaftor 150 mg at night.
~https://www.clinicaltrialsregister.eu/ctr-search/trial/2019-000833-37/ES"
15804322|NCT04415255|Other|EABPI plus IABPI|If the patient was assigned to EPABI plus IABPI, while the extrapleural space was reached, ~ 15 ml of autologous blood was injected at the extrapleural space through the coaxial needle. Then the central stylet was reinserted and the coaxial needle was advanced into the lung parenchyma with a single puncture. The needle was stopped inside the proximal part of the target and the center needle was removed. A 20-G/16 cm fully-automated biopsy needle was introduced through the 19-G/13.8 cm coaxial needle and specimens were identically obtained. After specimens were collected, the biopsy needle was removed, and immediately the remaining autologous blood (~5 ml) was slowly injected through the coaxial needle as it was withdrawn through the parenchyma thus sealing the needle tract.
15804323|NCT04415255|Other|IABPI-alone|If the patient was assigned to IABPI-alone, after collecting the biopsy specimens, immediately the autologous blood (~5 ml) was slowly injected through the coaxial needle as it was withdrawn through the parenchyma thus sealing the needle tract.
15804324|NCT04415242|Other|positioning|different positioning prior surgery
15804325|NCT04415216|Device|percutaneous coronary intervention|Percutaneous coronary intervention with drug eluting balloon (DEB) vs. thin struts drug eluting stents (thin-DES) for treating in-stent restenosis (ISR)
15804326|NCT04415203|Device|Transcutaneous acupoint electrical stimulation (TAES)|Patients in TAES group will receive TAES and usual care. TAES will be performed on Neiguan (PC6), Shenmen (HT7), Erzhong and Xin (Auricular Acupuncture Point) for 6 weeks by using the Huato type SDZ-V stimulator; Usual Care: usual medicine treatment for PVCs.
15804327|NCT04415203|Device|Sham Transcutaneous acupoint electrical stimulation (Sham-TAES)|Patients in sham-TAES group will receive sham-TAES and usual care. Sham-TAES will be also performed on Neiguan (PC6), Shenmen (HT7), Erzhong and Xin (Auricular Acupuncture Point) for 6 weeks by using a special Huato type SDZ-V stimulator. We cut the inner electric wire of the stimulator; therefore, there is no current output. Usual Care: usual medicine treatment for PVCs.
15804328|NCT04415190|Other|early palliative care|early palliative care
15804329|NCT04415177|Device|EaseVRx headset with active intervention|VR software developed by AppliedVR informed by evidence-based cognitive behavioral therapy principles, biofeedback and mindfulness strategies for pain management.
15804330|NCT04415177|Device|EaseVRx headset without active intervention|VR software developed by AppliedVR with neutral non-interactive content.
15804331|NCT04415164|Drug|Xueshuantong lyophilized powder|Xueshuantong lyophilized powder (500mg), diluted with 250 ml of 0.9% sodium chloride injection, IV (in the vein), once a day, continue for 10 days.
15804332|NCT04415164|Drug|Placebo|Xueshuantong lyophilized powder Placebo. The usage of placebo is the same as that in the experimental group.
15804333|NCT04415164|Other|Guidelines-based standard care|Guidelines-based standard care for acute ischemic stroke
15804337|NCT04415125|Diagnostic Test|Applying on-ice and off-ice performance tests|The subjects were given a written description of study procedures and potential risks.The athletes'history of injury including previous injury site, type, number, date, surgical status, time to return to the field after the injury and the mechanism of injury were recorded. The subjects completed off-ice performance measures followed by on-ice testing with time allotted for warm-up before both the off-ice and on-ice testing.
15804338|NCT04415112|Behavioral|Mediterranean Diet|A list of foods high consumption of vegetables, fruits, non-refined cereals, legumes and potatoes, moderate consumption of fish and poultry and low consumption of full fat dairies, red meat and its products and homemade sweets.
15804339|NCT04415112|Behavioral|Low Fat Diet|These children are forbidden to eat high-fat foods such as fried foods, butter, cream cheese, while foods such as fruits, vegetables (starchy and non-starch), cereals, poultry, lean meat and low-fat dairy products are allowed.
15804340|NCT04415099|Other|Muscle fatigue protocol|"Tibialis posterior was fatigued using 2 exercises:
~Unilateral heel raise exercise
~Close chain resisted foot adduction exercise"
15804342|NCT04415073|Drug|SNDX-6352|SNDX-6352
15804343|NCT04415073|Drug|Placebo|Placebo Comparator
15804344|NCT04415060|Drug|Isoflurane Inhalant Product|Isoflurane will be administered using an inhalation device
15804345|NCT04415060|Drug|Sevoflurane inhalant product|Sevoflurane will be administered using an inhalation device
15804346|NCT04415047|Device|JenaValve Pericardial TAVR System|TAVR with JenaValve Pericardial Valve and Delivery System
15804347|NCT04415034|Other|VAS and 5-D itch pruritus assessment|All subjects were evaluated for presence of pruritus using VAS and 5-D itch scale
15804348|NCT04415021|Other|Experimental: Diaphragmatic and İliopsoas Myofascial Release Techniques|Subjects in this arm will receive different myofascial release techniques aimed to relaxation the myofascial tension of the diaphragmatic and iliopsoas muscles.
15804349|NCT04415021|Other|Sham Comparator: Sham Myofascial Release Techniques|Subjects in this arm will receive the same manual techniques of the diaphragmatic and iliopsoas myofascial release group, but without the myofascial stimulus.
15804350|NCT04415008|Drug|HAD induction with intermediate dose cytarabine|daunorubicin,cytarabine,homoharringtonine
15804351|NCT04414995|Drug|Paracetamol injection and Ibuprofen injection|Use of combination acetaminophen and ibuprofen to reduce morphine requirement inpatient after Total knee arthroplasty
15804352|NCT04414995|Drug|Paracetamol injection and normal saline|Use of paracetamol and normal saline to reduce morphine requirement inpatient after Total knee arthroplasty
15804353|NCT04414995|Drug|Ibuprofen Injection and normal saline|Use of ibuprofen and normal saline to reduce morphine requirement inpatient after Total knee arthroplasty
15804354|NCT04414982|Behavioral|Intervention Values Affirmation|Participants are asked to circle the two or three values that are MOST important to them. Next, participants are asked to think about times when the values chosen might be important to THEMSELVES and then write a few sentences to describe when and why they might be important.
15804355|NCT04414982|Behavioral|Control Values Affirmation|Participants are asked to circle the two or three items that are LEAST important to them. Next, participants are asked to think about times when the values chosen might be important to SOMEONE ELSE and then write a few sentences to describe when and why they might be important.
15804356|NCT04414969|Drug|Anti-PD-1 antibody+Peg-Asparaginase+Chidamide|Anti-PD-1 antibody 200mg ivdrip d1, PEG-ASP 2500U/m2 im d1, Chidamide, 30mg, po, on d1，d5，d8，d12，d15，d19. The regimen was repeated every 3 weeks for 4 cycles followed by involved-field radiotherapy after got CR and PR (patients with efficacy of SD and PD withdrew from the study). Intensity-modulated radiation treatment was done by linear accelerator at 2.0 grays (Gy) per daily fraction with 5-6 weeks. The involved- field radiation (IFRT) dose was 54-56 Gy. During the radiotherapy, the anti-PD-1 antibody is administrated (200mg ivdrip, every 3 weeks) for 2 cycles. After the completion of radiotherapy, the subsequent 2 cycles of anti-PD-1 antibody + Peg-Asparaginase + Chidamide are administrated. After the end of all the above induction treatments , anti-PD-1 antibody (200mg ivdrip, every 3 weeks for up to 9 cycles) is given as maintenance therapy for 6 months (the total cycles of anti-PD-1 antibody is 17）.
15804357|NCT04414956|Diagnostic Test|AFP-L3|AFP-L3 will be tested using serum sample every 6 months.
15804358|NCT04414956|Diagnostic Test|AFP|AFP will be tested using serum sample every 6 months.
15804359|NCT04414956|Diagnostic Test|PIVKA-II|PIVKA-II will be tested using serum sample every 6 months.
15804360|NCT04414956|Diagnostic Test|Sonography|Sonography will be tested by experts every 6 months.
15804361|NCT04414956|Diagnostic Test|CT|Contrast-enhanced CT will be tested annually.
15804362|NCT04414943|Drug|S-ketamine|For women in this group, active drug (s-ketamine 0.2 mg/kg in 20 ml normal saline) will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth. They will be monitored for 60 minutes and then sent back to the ward.
15804363|NCT04414943|Drug|Placebo|For women in this group, placebo (20 ml normal saline) will be infused at a rate of 30 ml/h (infusion finished in 40 minutes) after giving birth. They will be monitored for 60 minutes and then sent back to the ward.
15804364|NCT04414930|Drug|AMPH|"Suppressing active psychosis with antipsychotics benefits cognitive interventions for schizophrenia, but it is possible that drugs with pro-cognitive effects will specifically, and perhaps synergistically, augment the clinical benefits of cognitive therapies. A proof of concept for this approach is found in the use of the pro-extinction drugs to selectively enhance the impact of cognitive therapy for anxiety disorders. In this proof of concept, a learning-based therapy is paired with a medication that enhances a brain mechanism (extinction) that is both 1) critical to that form of learning, and 2) known to be deficient in some anxiety disorders."
15804394|NCT04414683|Procedure|staging surgery|laparoscopic or laparotomic staging surgery
15804395|NCT04414670|Procedure|C/S|laparoscopic or robotic metroplasty
15804396|NCT04414657|Other|blood sampling for biobank|blood sampling for biobank
15804397|NCT04414644|Behavioral|Eating Condition|Participants will be randomly assigned to eat per the prescribed eating condition for 8 weeks during eating condition 1. They will complete the alternate eating condition for 8 weeks during eating condition 2.
15804365|NCT04414930|Drug|SHAM|"Suppressing active psychosis with antipsychotics benefits cognitive interventions for schizophrenia, but it is possible that drugs with pro-cognitive effects will specifically, and perhaps synergistically, augment the clinical benefits of cognitive therapies. A proof of concept for this approach is found in the use of the pro-extinction drugs to selectively enhance the impact of cognitive therapy for anxiety disorders. In this proof of concept, a learning-based therapy is paired with a medication that enhances a brain mechanism (extinction) that is both 1) critical to that form of learning, and 2) known to be deficient in some anxiety disorders."
15804366|NCT04414917|Drug|Twin block|Dental local anesthetic administered to target the jaw 'closer' muscles, temporalis and masseter
15804367|NCT04414917|Device|iPill dispenser|An active pill dispenser, regulated by patient's pain score entered on an iPill App installed on their smart phone (iPhone, Android) to dispense opioid (for pain corresponding to severe pain) or prescription strength ibuprofen and acetaminophen (for moderate pain), with over the counter solutions for mild pain recommended. This pill dispenser will be given to all patients, in both Twin block and Control groups, to regulate and monitor their pain experience-driven pain medication regimen. The pill dispenser will be packaged with pain medication (1 dispenser with vicodin, 1 with prescription ibuprofen, 1 with acetaminophen) that has been coencapsulated with ingestible event markers (IEMs, Proteus Discover).
15804368|NCT04414904|Other|Exposure: Covid-19 infection|Previous history of COVID-19 infection.
15804369|NCT04414891|Device|Non invasive ventilation|"Non invasive ventilation will be delivered using an oro-facial interface in both arms. NIV NAVA will be administered using Servo-i ventilator (Maquet, Getinge Group, Sweden) with software to compensate for air leaks.
~ASV arm will receive NIV using a Galileo GOLD ventilator (Hamilton Medical, AG, Switzerland)."
15804370|NCT04414878|Device|VitaFlow™ II Transcatheter Aortic Valve System|VitaFlow™ II Transcatheter Aortic Valve System contains a valve stent-VitaFlow™ Aortic Valve, a delivery system-VitaFlow™ Delivery System, loading tools, and a guide-wire
15804371|NCT04414865|Device|VitaFlow™ Transcatheter Aortic Valve System|VitaFlow™ Transcatheter Aortic Valve System contains a valve stent-VitaFlow™ Aortic Valve, a delivery system-VitaFlow™ Delivery System,loading tools, a balloon dilatation catheter, and an introducer set
15804372|NCT04414852|Drug|Apatinib Mesylate|All the subjects will be administrated with 250mg apatinib on day 1
15804373|NCT04414839|Device|Digital Intubation (Two-finger)|In the NGT Digital Intubation group (group B), the second and third fingers were placed in the posterior pharynx and depressed the tongue downwards. The NGT was passed through the nose into the posterior pharynx with the fingers in the pharynx to reach the esophagus. The thumb was placed under the jaw and pushed it forward to pave the way for tube insertion.
15804374|NCT04414839|Device|Video Laryngoscopy|In the NGT Video Laryngoscopy group (group A), first, the GlideScope blade was inserted under direct visualization via color monitor through the patient's mouth by employing jaw-thrust maneuver to preserve the cervical spine and by raising the tongue to obtain better visualization of the larynx space. Then, NGT was inserted through the selected nostril, advanced through the esophagus under direct vision to meet the measured length, and fixed after confirmation.
15804375|NCT04414826|Behavioral|Mindfulness Alone (MO) Intervention|Participants will receive a one-session, hour-long telehealth intervention emphasizing awareness and non-reactivity skills.
15804376|NCT04414826|Behavioral|Mindfulness + Compassion Intervention (MC)|Participants will receive a one-session, hour-long telehealth intervention emphasizing awareness, non-reactivity, and compassion skills.
15804377|NCT04414813|Biological|Human Amniotic Epithelial Stem Cells|Stereotactic transplantation of hAESCs for Parkinson's disease participants.
15804378|NCT04414800|Drug|Placebo|Distilled water
15804379|NCT04414800|Drug|Ketamine|1 mg/kg intranasal ketamine
15804380|NCT04414800|Drug|Fentanyl|1μg/kg intranasal fentanyl
15804381|NCT04414787|Behavioral|PCplanner|PCplanner-augmented care. The PCplanner mobile app will allow patients / family members to report their needs in a platform viewable by ICU physicians. Should the needs not improve over time, the palliative care team will be activated to contribute to care.
15804382|NCT04414774|Device|GG-Suicide-Ideation|GG-Suicide-Ideation (GGSI) is a mobile application, consisting of 55 stages. The content of each stage is a list of statements representing core themes, that were found in research and clinical practice to be related to suicide ideation. These are, for example, hopelessness, helplessness, thwarted belongingness, perceived burdensomeness, low self-esteem, tolerance of mental pain, and more. On each stage, several statements are presented on screen, one at a time. The statements express adaptive or maladaptive thinking in the specific core theme of that stage. In case the statement is positive and adaptive, the user needs to drag the statement downwards, towards him. In case the statement is negative and maladaptive, the user needs to drag the statement upwards, away from him. The user advances in stages - three stages per day.
15804383|NCT04414761|Drug|Progesterone|oral medroxyprogesterone 10 mg daily or duphaston 10mg bd daily from Day 3 till the day of ovulation trigger
15804384|NCT04414761|Drug|GnRH Antagonist|GnRH antagonist (Cetrorelix or Ganirelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger
15804385|NCT04414748|Drug|GnRH antagonist|GnRH antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of COH till the day of the ovulation trigger
15804386|NCT04414748|Drug|oral Duphaston|oral Duphaston 10mg bd from Day 3 of COH till the day of ovulation trigger.
15804387|NCT04414735|Other|Extracorporeal Photopheresis|Infusion of autologous cellular products exposed to ultraviolet light (UV), in the presence of a photosensitizer. The cellular product is obtained through leucopheresis and its subsequent exposure to 8-methoxypsoralen (8-MOP) and irradiation with UV-A light.
15804388|NCT04414722|Drug|Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet|Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
15804389|NCT04414722|Biological|BB-12|Bifidobacterium animalis subsp. lactis BB-12 (BB-12)-supplemented yogurt
15804390|NCT04414722|Other|Control|Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12)
15804391|NCT04414709|Other|Double short implant|Patients receives 2 short implants to restore missing posterior teeth, loaded with splinted screw retained crowns.
15804392|NCT04414709|Other|Single short implant|Patients receives single short implants, loaded with single screw retained crowns.
15804393|NCT04414696|Behavioral|Exercise intervention|eHealth exercise intervention for postpartum women at increased risk of depression
15804398|NCT04414631|Drug|Conestat alfa|Conestat alfa (8400 Units (U) followed by 4200 U every 8 hours, 9 administrations in total) will be administered as a slow intravenous injection (5-10 minutes) over a 72 hour period.
15804399|NCT04414618|Drug|Opaganib|Study participants will receive either opaganib 2 x 250 mg capsules (500 mg) every 12 hours, in addition to standard of care (pharmacological and/or supportive).
15804400|NCT04414618|Drug|Placebo|Study participants will receive placebo 2 x 250 mg capsules (500 mg) every 12 hours, in addition to standard of care (pharmacological and/or supportive).
15804401|NCT04414605|Drug|Gu Ben Hua Yu Fang decoction (Chinese herbal medicine)|Chinese herbal formula (Gu Ben Hua Yu Fang) decoction will be orally administrated twice daily. One pack of Gu Ben Hua Yu Fang will be taken for each time. Chinese herbal medicine (Gu Ben Hua Yu Fang) will not be used on the day of receiving secukinumab injection.
15804402|NCT04414605|Drug|Secukinumab Auto-Injector [Cosentyx]|Secukinumab will be administered by subcutaneous injection. The required dose (300 mg) is divided into two doses of 150 mg (contained in two separate syringes), which are injected at the same time. The first five doses (each consisting of 2 injections of 150 mg) are given at weekly intervals, with subsequent treatment given monthly (2 injections of 150 mg).
15804403|NCT04414592|Other|human umbilical cord mesenchymal stem cells|Twenty million human umbilical cord mesenchymal stem cells will be immediately injected into the degenerative discs of such patients who are diagnosed with lumbar disc herniation and operated with full endoscopy lumbar discectomy.
15804404|NCT04414579|Drug|Faster Insulin Aspart (Fiasp®)|Subjects will be randomized either to use Fiasp or conventional insulin aspart in CSII. CSII settings (basal, bolus, and correction factors) will be optimized using a meal challenge for a 2-week run in period followed by a 10-week period of CSII use with the assigned insulin. After a 12-week maintenance period, each group will cross over to the other insulin (conventional insulin aspart or Fiasp) by CSII for a second 2-week optimization period followed by a 10-week treatment period.
15804405|NCT04414566|Drug|gemcitabine and cisplatin; docetaxel, cisplatin and fluorouracil|Patients receive GP gemcitabine (1000 mg/m^2 d1,8) and cisplatin (80mg/m^2 d1) or TPF docetaxel (60mg/m^2 on day 1), cisplatin (60mg/m^2 on day 1) and fluorouracil (600mg/m^2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy.
15804406|NCT04414566|Radiation|IMRT|Intensity modulated-radiotherapy (IMRT) is given as 2.0 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor.
15804407|NCT04414566|Radiation|IMRT and concurrent cisplatin|Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.30 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor, concurrently with cisplatin 100 mg/m^2 every 3 weeks for 3 cycles.
15804408|NCT04414553|Behavioral|Community Active and Healthy Families|"Community-AHF will consist of eight, semimonthly 2-hour group appointments for 16 weeks followed by a visit with the pediatrician 2 months later and a final group session 4 months after that. Community-AHF sessions will target two areas: 1) Practical information regarding importance of healthy behaviors, and 2) Problem-solving skills to overcome barriers to improving diet and increasing physical activity and other related healthy behaviors. Each session covers specific objectives, includes a number of complementary activities and provides participants with take-home materials to facilitate behavior change.
~Community-AHF will be delivered by a nurse and a Community Health Worker (CHW) trained by a consultant nutritionist and study investigators. The CHW will contact families between group sessions to discuss challenges and successes regarding lifestyle changes."
15804409|NCT04414540|Drug|Metformin Extended Release Oral Tablet|Metformin ER starting dose 1000mg daily Metformin ER escalation dose 2000mg daily
15804410|NCT04414540|Drug|Pembrolizumab|Pembrolizumab q 3 weeks
15804411|NCT04414527|Behavioral|Standard counselling|"The control cohort will receive national standard counseling during four ante-natal care visits.
~Women in the control group will receive additionally
~national nutrition and health care including IFA supplementation,
~treatment of any symptomatic health condition and deworming in case of symptomatic complaints during second and third trimesters,
~Women who experience odor, itching or discharge will be treated for candidiasis and bacterial vaginosis."
15804412|NCT04414527|Behavioral|Health-Video|"The intervention cohort Health-Video will receive innovative video-based nutritional and hygienic education.
~Women in this group will receive additionally:
~National nutrition and health care including IFA supplementation
~treatment of any symptomatic health condition and deworming in case of symptomatic complaints during second and third trimesters,
~Women who experience odor, itching or discharge will be treated for candidiasis and bacterial vaginosis."
15804413|NCT04414514|Drug|Ruxolitinib 1.5% Cream|Topical Ruxolitinib 1.5% Cream
15804414|NCT04414501|Behavioral|Separation Anxiety|Perioperative anxiety is a common, undesirable outcome in pediatric surgical patients and has been associated with adverse outcomes.
15804415|NCT04414488|Procedure|Thoracic paravertebral block (ThPVB)|Before the induction of general anaesthesia a single-shot ThPVB was performed at the Th3 to Th4 level, approximately, 2.5 to 3 cm lateral to tip of a spinous process. A preblock ultrasound examination was undertaken to assess the depth of the transverse process and the pleura. An insulated 10 cm long needle was used and this was connected to a peripheral nerve stimulator with a set current of 2.5 milliampere(mA). The current was gradually reduced as the needle was inserted until the appearance of visible intercostal muscles activity with a current of 0.3 to 0.5mA (paravertebral space identification). Plain bupivacaine (0.3 ml*kg-1) was then injected after a negative aspiration test for air or blood. The efficacy of the blockade to cold was checked after 20 min with a plastic ampoule of saline kept in the freezer. Testing was symmetrical on both sides of thorax. A difference in sensation to cold between the blocked and unblocked sides was taken to indicate an effective block.
15804416|NCT04414475|Drug|Selinexor|Participants will receive Selinexor oral tablets.
15804417|NCT04414475|Drug|Dexamethasone|Participants will receive Dexamethasone oral tablets.
15804418|NCT04414475|Drug|Bortezomib|Participants will receive Bortezomib SC injection.
15804463|NCT04414007|Behavioral|Conventional rehabilitation|We provide patients with cardiac rehabilitation manuals and exercise logs. 4 weeks after ablation，Patients have CPET.Their exercise prescription was made according to CPET .The patients have rehabilitation training at home and recorded their exercise data including exercise time、type、frequency and average heart rate.
15804490|NCT04413721|Procedure|RBC transfustion|When the hemoglobin concentration fell below 7.0 g per deciliter, RBC were given to maintain the hemoglobin concentrations in the range of 7.0 to 10.0g /dL
15804419|NCT04414462|Other|exergaming training|"HEADING: For 5 mins a day,3 days a week in first 3 weeks (beginner level game) and for 10 mins a day, 3 days a week for 3 weeks. (advanced level game)
~TIGHTROPE TENSION: For 5 mins a day,3 days a week in first 3 weeks (beginner level game) and for 10 mins a day, 3 days a week for 3 weeks. (advanced level game)
~SNOWBOARD SLALOM: For 5 mins a day,3 days a week in first 3 weeks (beginner level game) and for 10 mins a day, 3 days a week for 3 weeks. (advanced level game)
~TABLE TILT: For 5 mins a day,3 days a week in first 3 weeks (beginner level game) and for 10 mins a day, 3 days a week for 3 weeks. (advanced level game)"
15804420|NCT04414462|Other|training - Group II|"Wobble board for 4 mins a day,3 days a week for first 3 weeks and for 8 mins a day,3 days a week for 3 weeks.
~Habituation exercises for 4 mins a day,3 days a week for first 3 weeks and for 8 mins a day,3 days a week for 3 weeks.
~Double leg stance with eyes open and eyes closed on firm surface and on foam for 4 mins a day,3 days a week for first 3 weeks and for 8 mins a day,3 days a week for 3 weeks.
~Single leg stance with eyes open and eyes open on firm surface and on foam for 4 mins a day,3 days a week for first 3 weeks and for 8 mins a day,3 days a week for 3 weeks.
~Tandem walk stance with eyes open and eyes closed on firm surface and on foam for 4 mins a day,3 days a week for first 3 weeks and for 8 mins a day,3 days a week for 3 weeks."
15804422|NCT04414436|Behavioral|GYNEA- digital coping program for women after gynaecological cancer|6 modules with relevant information and tools for coping after cancer
15804423|NCT04414423|Procedure|bone marrow concentrate alveolar cleft grafting|patients will undergo surgery to repair alveolar cleft with autogenous bone graft combined with bone marrow concentrate
15804424|NCT04414423|Procedure|Autogenous alveolar grafting|patients will undergo surgery to repair alveolar cleft with autogenous bone graft
15804425|NCT04414397|Device|JUVÉDERM VOLUMA® XC|JUVÉDERM VOLUMA® XC injectable gel
15804426|NCT04414384|Other|Abdominal Binder|Abdominal Binder placement
15804427|NCT04414384|Other|Step Counter|step counter to track steps
15804428|NCT04414371|Other|Yoga|Yoga Namaskar and Nadi Shuddhi
15804429|NCT04414345|Drug|CNM-Au8|"Drug: CNM-Au8
~Administration: Oral
~Dosage: 30 mg or 60 mg daily"
15804430|NCT04414345|Drug|Matching Placebo|"Drug: Matching Placebo
~Administration: Oral
~Dosage: 2 bottles daily"
15804431|NCT04414332|Other|Data collection only|This registry is to capture high quality patient safety and effectiveness data on use of the Angiovac device for 3 separate, but overlapping conditions; a) Iliofemoral and Caval DVT, b) Right heart masses, and c) PE. The goal will be achieved by capturing a concise set of immediate and short-term functional and clinical outcome data for all patients who have the angiovac catheter deployed into the vascular system.
15804432|NCT04414306|Other|In-person cancer screening education|Participants will receive verbal instruction covering the key messages, including risk factors, prevention, screening recommendations, and screening options pertaining to colorectal cancer. These in-person programs will take place in a variety of settings such as community-based organizations (e.g., community businesses, libraries, faith-based organizations, senior centers), fairs and community events, and clinical centers (e.g., health centers, local hospitals). Depending on the setting, education will be facilitated with one or more of the following educational tools: inflatable colon exhibit, PowerPoint presentation, flip chart/flip book, written materials/handouts, and displays. Data will be collected via pre- and post-tests. Some participants will be asked to participate in three and/or six-month follow-up surveys administered online or by telephone.
15804433|NCT04414306|Other|Online educational video and website module|Participants will receive online education via a video and website. Key messages will include information on risk factors, prevention, screening recommendations, and screening options pertaining to colorectal cancer. Some participants will be asked to participate in three and/or six-month follow-up surveys administered online or by telephone.
15804434|NCT04414306|Other|Online educational video|Participants will receive online education via a video and website about lung cancer screening. Some participants will be asked to participate in three and/or six-month follow-up surveys administered online or by telephone.
15804435|NCT04414306|Other|Message from healthcare system and online educational video and website module|Patients at one or more healthcare systems will receive a message from their healthcare provider or healthcare system indicating that they are due or overdue for colorectal cancer screening and receive information on how to schedule a related care (e.g. appointment with primary care provider to discuss screening options) and have the option of receiving education via on online video and website module with or without research study participation. Only recipients of this information who opt into the study through a consenting process will be considered study participants. Key messages will include information on risk factors, prevention, screening recommendations, and screening options pertaining to colorectal cancer. Some participants will be asked to participate in three and/or six-month follow-up surveys administered online or by telephone.
15804436|NCT04414293|Radiation|Lung Low Dose Radiation|The administration of low-dose lung radiation produces anti-inflammatory effects that will decrease the pulmonary inflammatory response.
15804437|NCT04414280|Device|Medtronic MiniMed 670G|The Medtronic Minimed 670G system is a form of hybrid closed-loop insulin delivery. The Medtronic MiniMed 670G system automatically adjusts basal insulin every five minutes based on CGM readings to reach a glucose target of 120 mg/dL, the SmartGuard Auto Mode. Patients still need to enter their carbohydrate intake and administer meal-time and correction boluses. Before Auto Mode is introduced, the Medtronic MiniMed 670G system has to be worn in Manual Mode. In contrast to Auto Mode, Manual Mode features an insulin stop up to 30 minutes before or when reaching preset low limits (suspend before/on low) and an automatic insulin restart when blood sugar levels recover. During Manual Mode the pump 'becomes familiar with' the daily insulin need of the patient. This information will be used when in Auto Mode.
15804438|NCT04414280|Device|Medtronic MiniMed 780G|The Medtronic Minimed 780G system differs in several aspects from the MiniMed 670G system. In Auto Mode, the user can choose from two target levels for even more stricter glucose control (100 mg/dL and 120 mg/dL) and correction boluses are now automated without the need of user interaction. When administering meal boluses, no capillary blood glucose value is required. The safety feature to exit from Auto Mode to Manual Mode was too strict in the Minimed 670G. In the Minimed 780G this is more flexible to overcome this frequently reported patient frustration.
15804488|NCT04413734|Drug|Combination therapy|Triprilumab by intravenous infusion accompanying with Gemcitabine plus Cisplatin
15804439|NCT04414280|Device|Tandem Control-IQ|The Tandem t:slim X2 Control-IQ consists of the Tandem t:slim X2 insulin pump with Control-IQ technology, and integrates with the Dexcom G6 CGM-device via Bluetooth. Blood glucose readings for calibration are not required. The Tandem t:slim X2 Control-IQ automatically adjusts basal insulin based on CGM readings to reach a glucose target range between of 112-160 mg/dL. Patients still need to enter their carbohydrate intake and administer meal-time boluses, but the system automatically increases the basal insulin dose or gives automated correction boluses in case of high blood glucose levels. The technology offers optional settings for sleep and exercise, with different glucose targets in order to match the insulin need during these activities. New versions of the pump software can be downloaded and installed remotely via the user's own computer.
15804440|NCT04414267|Biological|BCG vaccine|Patients susceptible to SARS-CoV-2 infection will be vaccinated with one intradermal injection of 0.1ml of BCG vaccine
15804441|NCT04414267|Biological|Placebo|Patients susceptible to SARS-CoV-2 infection will be vaccinated with one intradermal injection of 0.1ml of sodium chloride 0.9%
15804442|NCT04414254|Drug|Cefprozil 125mg/5ml Susp; Cefprozil granule (125mg)|"Subjects were allocated to one of two groups randomly and equally with a 3-day washout interval between the two periods.Cefprozil for Suspension® (125mg/5mL, 50mL/bottle, batch no. F701087, manufactured by Lupin Pharmaceuticals, Inc.) and cefprozil granule (125mg, batch no. 8G001F07, manufactured by Qilu Pharmaceutical Co., Ltd) were used in this study."
15804444|NCT04414228|Device|M-Entropy guidance of anesthesia depth|In the M-Entropy group, dosage of volatile anesthetics will be adjusted to achieve the response and state entropy values between 40 and 60 from the start of anesthesia to the end of surgery. In the control group, dosage of volatile anesthetics will be titrated according to clinical judgment.
15804445|NCT04414228|Device|ProAQT in guiding goal-directed hemodynamic therapy|If stroke volume variation is ≥ 10%, a bolus of 150 ml of crystalloid fluid will be given until the stroke volume variation is < 10%. If mean arterial pressure is < 70 mmHg and/or cardiac index < 2.5 l·min-1·m-2 despite the stroke volume variation of < 10% following fluid challenge, single or consecutive boluses of ephedrine 4 mg and/or continuous intravenous infusion of norepinephrine 2-10 μg·min-1 will be administered.
15804446|NCT04414215|Behavioral|Emotional working memory training|Participants will complete an emotional working memory n-back training program that progressively increases difficulty and has been shown to enhance prefrontal activity in a non-psychiatric sample
15804447|NCT04414215|Behavioral|Placebo working memory training|Working memory training that does not involve emotional stimuli using an N-back training program
15804448|NCT04414202|Procedure|tumorectomy with axillary dissection (sentinel lymph node)|All patients will have local excision of the primary tumor following appropriate clinical work-up. Surgery will be done according to usual local practice with a complete excision of the tumor. The aim of the local excision should be to achieve a minimum free margin of 2 mm whilst maintaining a good cosmetic outcome.
15804449|NCT04414202|Radiation|per-operative partial irradiation|20 Gy of per-operative partial irradiation at the tumor site during the surgery
15804450|NCT04414189|Diagnostic Test|HostDx Sepsis|Blood collection for mRNA analysis
15804451|NCT04414163|Drug|IMC-001|Single dose level for enrollment subject (IMC-001 20mg/kg every 2 weeks)
15804452|NCT04414150|Drug|SHR-1802|This study will evaluate the preliminary safety, tolerability, pharmacokinetic characteristics and initial efficacy of SHR-1802 The goal is to establish the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of sequential escalating doses of SHR-1802 when administered to patients with locally advanced/ unresectable or metastatic malignant tumours that are refractory to available therapy or for which no standard therapy is available.
15804453|NCT04414137|Other|Description of eosinophilic pneumonia due to daptomycine|Description of eosinophilic pneumonia in patients treated by daptomycin for an osteoarticular infection
15804454|NCT04414124|Other|KB109 + Self Supportive Care (SSC)|KB109 is a novel glycan
15804455|NCT04414124|Other|Self Supportive Care (SSC) Alone|Self Supportive Care (SSC) Alone
15804456|NCT04414111|Diagnostic Test|Highly suppressive Treg measurement|Circulating highly suppressive Treg measurement
15804457|NCT04414098|Drug|INC424 / Ruxolitinib|"Ruxolitinib 5 mg orally every 12 hours during 14 days.
~Total Follow-up time will be of 45 days.
~The reduction of ruxolitinib dose will be considered in cases of drug-related cytopenias.
~During hospitalization, clinical and laboratory evolution parameters will be recorded daily in the medical history of the patient and in the data collection table of the study. Upon patient's discharge, a follow-up will be conducted until day +45
~During hospitalization, adverse events will be monitored daily by means of clinical assessment and laboratory data.
~After discharge, monitoring of adverse events will continue during the outpatient follow-up.
~Pro-inflammatory parameters will be assessed at baseline, after one week (day +7) and at the end of treatment (day +14)
~Ruxolitinib will be associated to the standard of care for COVID-19 of each center.
~In case of an adverse effect or a need to discontinue the treatment, ruxolitinib should be suspended."
15804458|NCT04414072|Procedure|sleeve gastrectomy with loop bipartition|operations to decrease weight
15804459|NCT04414046|Biological|Haploidentical Hematopoietic Cell Transplantation|TCR alpha beta T-cell and CD19 B-cell depleted haploidentical transplantation
15804460|NCT04414033|Device|Bubble: A New VR-AI Way of Treatment for Hot Flashes|Bubble Bubble is a virtual reality (VR) mobile application. Bubble offers a psychological intervention based upon cognitive behavioral therapy (CBT) and mindfulness-based stress reduction (MBSR) protocols. The bubble mobile application offers the intervention in a virtual reality (VR) coaching environment and in a winter wonderland setting called Frosty. Frosty provides both a virtual reality winter wonderland experience as well as guided meditation. The cold, winter-like experience is designed to help patients calm down and feel cooler.
15804461|NCT04414020|Drug|Progesteron|intramusculer progesterone
15804462|NCT04414007|Behavioral|Internet+ home-based cardiac rehabilitation|The Internet+ home-based cardiac rehabilitation group receive home-based cardiac rehabilitation program through Internet platform and intelligent wearable devices .
15804489|NCT04413734|Drug|Mono-chemotherapy|Gemcitabine plus Cisplatin by intravenous infusion
15804527|NCT04413383|Other|Traditional Curved Iris Scissors|Aesculap Curved Iris Scissors
15804464|NCT04413994|Dietary Supplement|Humavant|"Premature infants are randomized to either:
~An exclusive human milk diet which contains mother's milk or pasteurized donor human milk and the human milk fortifier until 36 weeks of gestation; OR
~Human milk (as long as available) and the human milk fortifier (as long as human milk is available) until a maximum of 32 weeks of gestation and thereafter human milk with a bovine-based fortifier or preterm formula.
~After 36 weeks of gestation, human milk with a bovine-based fortifier or preterm formula is used in both groups. As a control group, term-born age-matched controls are included."
15804465|NCT04413968|Diagnostic Test|Rapid detection test|Rapid serological test by taking 3 drops of blood from the fingertip via the TDR device (rapid detection test) for children, supervising nursery staff and hospital laboratory and administrative staff
15804466|NCT04413968|Diagnostic Test|Nasopharyngeal swab|Posterior nasopharyngeal swabbing in children
15804467|NCT04413968|Diagnostic Test|Stool collection|Stool collection in children
15804468|NCT04413955|Device|Seraph®-100 Microbind® Affinity Blood Filter|Use of an extracorporeal broad-spectrum sorbent hemoperfusion filter to removed SARS-CoV-2 virus and circulating cytokines from the blood
15804469|NCT04413942|Biological|FB825|Humanized monoclonal IgG1 specifically targeting the CεmX domain of membrane-bound IgE
15804470|NCT04413942|Other|Placebo|Formulation buffer
15804471|NCT04413929|Drug|Ergoferon|Oral administration
15804472|NCT04413916|Diagnostic Test|miRNA expression|Analysis of expression of selected miRNAs (miR-29c, miR-126, miR-146a, miR-150, miR-155, miR-223) by qPCR.
15804473|NCT04413903|Procedure|The Effect of Different Mechanical Ventilator Modes on Optic Nerve Diameter and Cognitive Functions in Laporoscopic Cholecystectomy Operations|The Effect of Different Mechanical Ventilator Modes on Optic Nerve Diameter and Cognitive Functions in Laporoscopic Cholecystectomy Operations
15804474|NCT04413890|Drug|Dinoprostone vaginal gel|Prostaglandin gel 0.5, 1 or 2 mg
15804475|NCT04413864|Other|Inflammatory cytokines and chemokines profiles of patients with dexmedetomidine administration|"Assigned Interventions:
~Blood samples collection at inclusion (D0) and follow-up visits (D2, D7 and M6)
~CAM-ICU scores during ICU hospitalisation, neurological questionnaires at M6 (GOAT, GOSE, MOCA, Barthel Index, PTSD, GDS, Rankin score, HADS)"
15804476|NCT04413838|Drug|NIVOLUMAB|IV injection within 30 minutes of 24ml file (=240 mg) containing NIVOLUMAB BMS(Bristol-Myers Squibb) 10mg/ml (immune check point inhibitor targeting PD-1) on top of routine standard of care for COVID-19 infection
15804477|NCT04413838|Other|Routine standard of care|No intervention is planned in this arm. Patients will follow routine standard of care for the COVID-19 treatment
15804478|NCT04413812|Behavioral|FREEBASE exercise programme|"The exercise programme will be initialized 1-10 months following bariatric surgery and last for 3 months. The programme will be mainly delivered in two groups consisting of 10-12 subjects each and will be held in the facilities of a fitness studio and remotely at home. The programme consists of 24 units (two per week, the lesson in the fitness studio lasting for 75 minutes and the remote lesson lasting for 45 minutes.This is due to the COVID-19-related social distancing restrictions. The intervention combines the following elements: a) exercise training in a group, b) interactive workshops on basic knowledge of training sciences and techniques of behavior change and c) an individual exercise counselling session.
~The programme will be medically supervised and the content will be taught and instructed by members of the research team qualified in exercise science and sports physiology."
15804479|NCT04413799|Combination Product|lidocaine, ketamine intravenous infusion|"Patients will be started with our standard analgesia regiment which is standing oral acetaminophen 1000mg every 8 hours, ibuprofen 600mg every 6 hours or celecoxib 200mg every 12 hours, and narcotics as needed. All patients who failed the standard analgesia regimen will be approached for the study. Failure of standard analgesia regimen will be determined by respirations >20 minute, tidal volume ≤50% of predicted, numeric pain score ≥ 5, and a poor cough as determined by the trauma team.
~Once the consent is obtained, the patients will be randomized to either PVB (control) or lidocaine/ketamine (study) groups. If the patient is randomized to lidocaine/ketamine group, the anesthesiologist led Acute Pain Service (APS) will prescribe lidocaine/ ketamine infusion, which will be monitored and titrated as necessary by APS. Standard analgesia will be continued on both study groups"
15804480|NCT04413799|Drug|paravertebral block with ropivicaine|"Patients will be started with our standard analgesia regiment which is standing oral acetaminophen 1000mg every 8 hours, ibuprofen 600mg every 6 hours or celecoxib 200mg every 12 hours, and narcotics as needed. All patients who failed the standard analgesia regimen will be approached for the study. Failure of standard analgesia regimen will be determined by respirations >20 minute, tidal volume ≤50% of predicted, numeric pain score ≥ 5, and a poor cough as determined by the trauma team.
~Once the consent is obtained, the patients will be randomized to either PVB (control) or lidocaine/ketamine (study) groups. If the patient is randomized to PVB, the anesthesiologist led Acute Pain Service (APS) will place a paravertebral block catheter. Ropivacaine infusion will be started, monitored and titrated as necessary by APS. Standard analgesia will be continued on both study groups"
15804481|NCT04413786|Drug|oxytocin treatment|intranasal administration of oxytocin (24IU)
15804482|NCT04413786|Drug|placebo treatment|intranasal administration of placebo (24IU)
15804483|NCT04413773|Other|Treatment as usual + Video|Additionally to treatment as usual a video is shown to participant about procedures on the ward before, during and after surgery
15804484|NCT04413773|Other|Treatment as usual|Explanation of standard procedures before, during and after surgery by nurse
15804485|NCT04413747|Behavioral|morning Yoga-based breathing support|Low and deep inspiration and phonetic syllable OM laryngeal vibration ( OM technique) as expiratory exercises, sitting in easy pose. The length of more than 5 -8 sec. and frequency between 20 and 23 breaths /min. Conscious breath number (n°) of 15 respiratory acts (RAc) and OM technique n° of 5 RAc and Bhramari pranayama n° of 5 RAc.
15804486|NCT04413747|Behavioral|pre_lunch Yoga-based breathing support|Low and deep inspiration and OM technique as expiratory exercises, sitting in easy pose.The length of more than 5 -8 sec. and frequency between 20 and 23 breaths /min. Conscious breath number (n°) of 15 respiratory acts (RAc) and OM technique n° of 5 RAc and Surya Bheda pranayama n° of 5 RAc.
15804487|NCT04413747|Behavioral|pre_dinner Yoga-based breathing support|Low and deep inspiration and OM technique as expiratory exercises, sitting in easy pose.The length of more than 5 -8 sec. and frequency between 20 and 23 breaths /min. Conscious breath number (n°) of 15 respiratory acts (RAc) and OM technique n° of 5 RAc and Nadi Shodhana pranayama n° of 5 RAc.
15804491|NCT04413708|Behavioral|P3-T PrEP Adherence App|"P3-T provides daily PrEP reminders, a medication tracker and calendar, personalized medication adherence strategies, refill reminders, and tailored adherence support messages; social support via a social wall that includes daily discussion prompts; daily quests to build knowledge and skills; a multimedia knowledge center; interactive narrative collections; personalized adherence counseling provided by an adherence counselor via in-app messaging; in-app rewards; a bank account that rewards daily app use by adding or subtracting a small financial reward based on daily app use; and, a user profile that includes a user-selected avatar."
15804492|NCT04413682|Behavioral|Structured Supervised Exercise|Structured Exercise Program under the supervision of Physical Therapist
15804493|NCT04413682|Behavioral|Structured telerehabilitation|Structured Exercise Program checked and controlled through telerehabilitation
15804494|NCT04413669|Procedure|white light bronchoscopy & autofluorescence bronchoscopy|White light bronchoscopy and autofluorescence bronchoscopy were carried out，and Take a biopsy for abnormal bronchial mucosa
15804495|NCT04413656|Other|ablation|Patients with stage IA inoperable peripheral lung tumor will be performed ablation. cfDNA methylation would be monitored at different times(before surgery , after surgery 1month, 3month, and every 3month in the first year and every 6 months in the second ).
15804496|NCT04413656|Other|surgery|Patients with stage IA inoperable peripheral lung tumor will be performed ablation. cfDNA methylation would be monitored at different times(before surgery, after surgery 1month, 3month).
15804497|NCT04413643|Device|Noninvasive Ventilation|The use of non-invasive ventilation (NIV) has been extensively evaluated in both patients with stable disease in the home setting and in AECOPD during hospitalization. It is widely accepted that NIV used during AECOPD in the inpatient setting reduces rates of endotracheal intubation, as well as length of ICU and hospital stay. Long-term use of NIV, particularly at higher pressures, in the home setting in COPD patients with evidence of chronic compensated respiratory acidosis (PaCO2 >45mmHg) decreases elevated PaCo2 and serum bicarbonate levels, improves pulmonary function, and improves quality of life. Little is known about whether patients initiated on NIV during an AECOPD and subsequently transitioned to long-term home NIV on discharge demonstrate reduced AECOPD rates, readmission rates, or differences in morbidity and mortality.
15804498|NCT04413630|Other|family workshop|The family workshop with 5 courses, with 6 families in one course The intervention of one course; 2 hours per session, one time per week, for a total of 6 weeks
15804499|NCT04413617|Drug|PF-06650833|400 mg
15804500|NCT04413617|Drug|PF-06651600|100 mg
15804501|NCT04413617|Drug|Tofacitinib|11 mg
15804502|NCT04413604|Other|Young children's milk (1-<3)|young children's milk containing protein, energy and fat and micronutrients, in accordance with global and local nutritional recommendations for ages 1-3.
15804503|NCT04413604|Other|Young children's milk (3-5)|young children's milk containing protein, energy and fat and micronutrients, in accordance with global and local nutritional recommendations for ages 3-5.
15804504|NCT04413591|Behavioral|Community based combination HIV prevention package|The intervention compares the efficacy of a community-based comprehensive HIV/STI prevention package compared to standard of care (HIV testing, counseling, and referrals) among Female Sex Workers.
15804505|NCT04413578|Device|Dexcom G6|Continuous Glucose Monitor that, after applied, sends continuous glucose readings to to the patient's smartphone every 5 minutes. This allows the patients to receive more readings over a 24 hour period versus standard of care glucometer finger sticks.
15804506|NCT04413578|Device|Contour NextOne|A Standard of Care Glucometer with Bluetooth capability. The patient inserts a test strip into the device, takes a finger stick and collects a small blood sample on the tip of the strip to initiate the device to detect a glucose reading.
15804507|NCT04413565|Procedure|Simultaneous bilateral total knee arthroplasty|Two surgeon bilateral TKA group
15804508|NCT04413565|Procedure|Sequenced bilateral TKA|Single surgeon bilateral TKA group
15804509|NCT04413552|Drug|INDV-2000|Study medication (active) will be administered as either powder in solution or powder in capsule, depending on dose administered.
15804510|NCT04413552|Other|matching placebo|Study medication (placebo) will be administered as either powder in solution or powder in capsule, depending on dose administered.
15804511|NCT04413526|Procedure|radiofrequency|radiofrequency combined with liver resection
15804512|NCT04413526|Procedure|TACE|only TACE treatment
15804513|NCT04413526|Procedure|TACE+radiofrequency|TACE followed by radiofrequency
15804514|NCT04413513|Other|Integrated Attention Training Program (IATP)|Integrated attention training program (IATP) is a newly developed cognitive training programs that combined relaxation technique with integrated attentional training into daily life activity.
15804515|NCT04413513|Other|Health Education|Health educational sessions on health concerns and physical diseases commonly found in old age
15804516|NCT04413500|Behavioral|Reminder|A reminder to take the anti-hypertension medication with adjustable frequency.
15804517|NCT04413500|Behavioral|Educational message|An educational message to increase the knowledge about various facts around hypertension. The short messages are supposed to be sent based on the patient's needs.
15804518|NCT04413500|Behavioral|Motivational messages|The motivational short messages to increase the motivational levels.
15804519|NCT04413500|Behavioral|showing trends|Short messages contain different trends of medication intake rate, BP, physical activity rate, and so on.
15804520|NCT04413487|Other|Extra echocardiogram|Subjects will receive an extra echocardiogram after 2 cycles of chemotherapy
15804521|NCT04413461|Other|TENS|Transcutaneous Electro Neuro Stimulation
15804522|NCT04413461|Other|TENS Sham|placebo of Transcutaneous Electro Neuro Stimulation : similar device without electro stimulation
15804523|NCT04413435|Other|File Scanning|The patients' epidemiological, clinical, laboratory, and radiological characteristics and treatment and outcomes data will accessed from Hospital Data Management System (HDMS) of Konya Training and Research Hospital and Public Health Management System (PHMS) of Ministry of Health.
15804524|NCT04413422|Drug|type of hypnotic used for induction of general anesthesia|
15804525|NCT04413409|Procedure|Metastasectomy for the metastatic sites|patients randomized to this group will receive metastasectomy for the metastatic sites then followed by the systemic therapy
15804526|NCT04413396|Procedure|Outpatient Parenteral Antibiotic Therapy|Application of outpatient parenteral antibiotic therapy in patients with infectious diseases to allow them to get discharged from hospital.
15804529|NCT04413383|Other|Comparative Experience of Traditional and Wuennenberg Modified Curved Iris Scissors|Patients experience both types of scissors
15804530|NCT04413370|Diagnostic Test|Dry eye diagnostic test|The artificial intelligent dry eye screening platform
15804534|NCT04413344|Drug|Bromocriptine|TW-012R: Each tablet contains 2.87 mg of bromocriptine mesilate (JP) (2.5 mg of bromocriptine)
15804535|NCT04413344|Drug|Placebos|Placebo: Identical tablets which contain no active ingredient
15804536|NCT04413331|Other|Data collection|Medical data collection at M0, M3, M6, M9 and M12 then every 6 months until M60 and at each vascularitis relapse
15804537|NCT04413331|Other|Biological samples and data collection|Biological samples at M0, M6, M12, M24 and at each relapse until M60
15804540|NCT04413305|Other|screen of CRKP and infection control measure|For intervention group, we screen admitted patients for carbapenem-resistant Klebsiella pneumoniae and carry out 'Bundle' infection and control measures. When outbreak or tranmission of CRKP was observed, we take whole-genome sequencing to track origin and transmission route to decease CRKP rate.
15804541|NCT04413292|Diagnostic Test|ELISA assays and Westren blot analysis of survivin and fibulin-3 expression|expression analysis of biomarkers
15804542|NCT04413279|Procedure|LipiFlow Thermal Pulsation|To manage patients with dry eye disease secondary to MGD
15804543|NCT04413279|Drug|Dexamethasone Intracanalicular Insert, 0.4mg with LipiFlow Thermal Pulsation|to investigate the benefit of managing patients with DED secondary to MGD with a sustained release intracanalicular dexamethasone (0.4 mg) insert in addition to LipiFlow Thermal Pulsation
15804544|NCT04413266|Dietary Supplement|Curcumin supplementation|The patients will receive 3 capsules per day containing 500mg of curcumin for 4 weeks
15804545|NCT04413253|Drug|Lifitegrast 5% Ophthalmic Solution|To reduce signs and symptoms of dry eye disease
15804546|NCT04413253|Drug|Dexamethasone Intracanalicular Insert, 0.4mg with Lifitegrast 5% Ophthalmic Solution|To determine the outcomes of reduction of signs and symptoms of dry eye disease with DEXTENZA as an added therapy, in addition to Xiidra therapy.
15804547|NCT04413240|Device|Telerehabilitation|"VRRS is a medical device to perform cognitive telerehabilitation and home speech therapy in online or offline mode.
~K-Wand is an additional device to VRRS for motor telerehabilitation of the upper limb and trunk. It works with a set of motion sensors through light recognition technology.
~Khymu is a set of sensors added to the VRRS used to carry out motor telerehabilitation activities of the lower limb. The use in combination with the K-Wand is able to allow full-body motor telerehabilitation.
~Patients will have at their home a special workstation connected to the internet. The same equipment will also be present in the reference structure. Only the online telerehabilitation mode will be used, including an audio and video teleconference. The rehabilitator will be able to remotely control the patient's system. The patient, will see on his screen the exercises to be performed, their realization and the results achieved."
15804548|NCT04413240|Other|Conventional rehabilitation|It is not possible a priori to precisely define the instruments that will be used during rehabilitation management. The telerehabilitation or conventional treatment methods (type of therapeutic exercise, modality of cognitive stimulation and/or taking care of speech therapy) will be determined for each patient on the basis of the needs emerging from the physiatric examination performed at T0, defined according to the Individual Rehabilitation Project and applied according to each Rehabilitation Program (motor, cognitive and/or speech therapy) periodically updated.
15804549|NCT04413227|Drug|Pegylated Recombinant Human Endostatin（PEG-ENDO）|PEG-ENDO 1 mg/kg or 2 mg/kg or 4 mg/kg or 6 mg/kg or 8 mg/kg+Docetaxel 75 mg/m2，once every 3 weeks at day 1
15804550|NCT04413214|Drug|Carrimycin|The study involves three dose groups: 200mg, 400mg and 600mg. Three patients are planned for each dose group. Starting from the low dose group, the treatment to three patients in the 200mg dose group: 200mg of Carrimycin after meals every morning (po) for three weeks, and then discontinue for one week, the tolerance and efficacy evaluation will be performed after the 4 weeks. DLT will be recorded during the 4 weeks.
15804551|NCT04413201|Drug|Afatinib|Afatinib followed by osimertinib or ICT
15804552|NCT04413201|Drug|Osimertinib|Osimertinib followed by ICT
15804553|NCT04413188|Other|Warm foot bath|The participants in experimental group were asked to soak their feet in warm water (38-40°C) for 20 minutes one hour before their bedtimes for six weeks. A special foot bath (Beurer FB50 luxury foot bath spa with water heater) was used for this purpose. The bath is 10 cm deep; it keeps water at a constant temperature of 35-48°C for 15-60 minutes, has a display screen for water temperature and duration of use, and turns off automatically.
15804554|NCT04413175|Other|music therapy|"Patients in the music group were provided music therapy that was prepared by the Turkish Psychological Association. They listened to the music that has a calming and relaxing effect for 20 min before and during the procedure.
~A portable MP3 player connected to double earphones was used in the present study. After patients took the lithotomy position for cystoscopy, their headphones were inserted and music began to be played. Music was played to the individuals for 20 minutes before and during the procedure. Headphones were removed immediately after the procedure was completed and the double earphones were cleaned with antiseptic solution after each application."
15804555|NCT04413162|Other|Kinect motion tracking system|Kinect motion tracking system is used to measure shoulder range of motion compared to goniometric measurement.
15804556|NCT04413136|Behavioral|Web-ORLA|
15804557|NCT04413136|Behavioral|Control|
15804558|NCT04413123|Drug|Cabozantinib|Cabozantinib predetermined protocol dosage po daily
15804561|NCT04413110|Device|Polysomnography|PSG was carried out for 41 patients with subjective cognitive impairment and 41 age and sex-matched controls. PSG with standard EEG montage that includes bilateral EOG and four EEG leads were used. A single attended overnight PSG study was performed at the Clinical Neurophysiology Unit of Mansoura University Hospitals. Patients were studied in a quiet, darkened room with no medications were used to induce sleep. All participants underwent one night of laboratory-based PSG.
15804562|NCT04413097|Procedure|Delayed Cord Clamping with Low Oxygen concentration|During delayed umbilical cord clamping of 90 seconds, breathing assistance with CPAP/PPV and low oxygen concentration (FiO2 0.30) will be provided.
15804563|NCT04413097|Procedure|Delayed Cord Clamping with High Oxygen concentration|During delayed umbilical cord clamping of 90 seconds, breathing assistance with CPAP/PPV and high oxygen concentration (FiO2 1.0) will be provided.
15804564|NCT04413084|Other|Gaze stability exercises|Business card will be placed at eye level. Begin with simpler exercises and progress toward harder one.
15804565|NCT04413084|Other|Brandt-Daroff Exercises|"Brandt-Daroff Exercises
~Start sitting upright on the edge of the bed.
~Turn your head 45 degrees to the left, or as far as is comfortable.
~Lie down on your right side.
~Remain in this position for 30 seconds or until any dizziness has subsided.
~Sit up and turn head back to center.
~Turn your head 45 degrees to the right, or as far as is comfortable.
~Lie down on your left side.
~Remain in this position for 30 seconds or until any dizziness has subsided.
~Sit up and turn head back to center."
15804566|NCT04413071|Other|Passed infection of SARS-CoV-2|This is an observational design. Participants have passed infection from SARS-CoV-2 and a cardiac assessment is performed.
15804567|NCT04413045|Other|Prevalence of COVID-19|All COVID-19 cases to be admitted in the assigned hospital with positive results of nasopharyngeal swab for SARS-CoV-2 during one-month duration.
15804568|NCT04413032|Device|DreaMS|The dreaMS App is a data communication platform collecting data from the patients' mobile devices (smartphone and wearables). We analyze app-based tests, surveys and sensor data.
15804569|NCT04413019|Other|Clinical follow up|"Patients recruited in this study commenced antibiotic treatment according to the recent guidelines :
~Erythromycin 250 mg 4 times daily for 10 days following the diagnosis of PPROM, or until the women is established labor (whichever sooner)
~Penicillin may be used in patients who can't tolerate erythromycin
~In cases of penicillin allergy: Cefazolin 1 g intravenously every 8 hours for 48 hours, followed by cephalexin 500 mg orally four times daily for five days. These drugs provide coverage for both GBS and Escherichia coli, the two major causes of neonatal infection."
15804570|NCT04413006|Behavioral|Self-Compassion for Chronic Pain Virtual Group Treatment Program|6-session group via video-conferencing for informational and experiential exercises to increase self-compassion in individuals with chronic pain
15804571|NCT04412993|Other|withdraw blood samples|withdraw blood sample from gorup O donors
15804572|NCT04412967|Device|Dynamic ultrasound-guided short-axis needle tip navigation|placement of peripheral venous catheters using ultrasound guided technique
15804573|NCT04412967|Other|Standard technique of placing a PVC|Standard technique with palpation or Visual inspection of the pvc placement site
15804574|NCT04412954|Behavioral|Smartphone + Text Messaging with Health Coach|The program includes (1) use of a free commercially available smartphone application program for 12 months, (2) a wearable Fitbit Charge device that will be provided by the study to monitor active minutes, and (3) one 45-minute behavioral counseling session focused on healthy eating and exercise and (4) personalized text messaging for 6 months by a health coach. The health coach will not send feedback during months 6-12. The intervention will be fully self-directed in these months, as there will be no contact between the 6 months visit and 12-month visit.
15804575|NCT04412941|Behavioral|Myofunctional exercises|"Myofunctional exercises: Respiratory rehabilitation exercises with diaphragmatic breathing, thoracic mobilization exercises and manual pompage techniques, followed by manual trigger point therapy techniques, that were identified by palpation following the guidelines provided by Travell and Simons trigger point manual, the accessory inspiratory muscles like pectoralis minor muscle, scapula elevator muscle, Sternocleidomastoid muscle.
~Home oropharyngeal exercises: at every patient will be taught oropharyngeal exercises to perform at home twice a day (the duration of 15 minutes each session) involving in particular exercises for soft palate, tongue, facial and genio-glosso muscle.
~The rules of sleep hygiene: a list of behaviours that physiologically promote a good night's sleep."
15804576|NCT04412941|Behavioral|The rules of sleep hygiene|The rules of sleep hygiene: a list of behaviours that physiologically promote a good night's sleep.
15804577|NCT04412928|Procedure|mid-urethral sling procedure|mid-urethral sling procedure
15804578|NCT04412915|Other|Labor induction|Labor induction with oxytocin or prostagladin
15804579|NCT04412902|Drug|adjuvant therapy|Adjuvant chemotherapy and/or radiotherapy
15804580|NCT04412889|Biological|BCMA/CD19 dual-target CAR-T cell immunotherapy|The intervention is a CAR-T cell immunotherapy targeted CD19 and BCMA. The dosage ranges from 2×10^5 to 1×10^6 CAR+T/Kg.
15804581|NCT04412876|Drug|Duloxetine|Duloxetine 30 mg qd
15804582|NCT04412876|Drug|Imipramine|Imipramine 25mg qd
15804583|NCT04412863|Drug|VIR-2218|VIR-2218 given by subcutaneous injection
15804584|NCT04412863|Drug|pegylated interferon-alfa 2a|pegylated interferon-alfa 2a given by subcutaneous injection
15804585|NCT04412850|Drug|Magnesium Sulfate|"Magnesium and placebo (Normal Saline) will be prepared as solutions of identical volume and appearance. All patients will be randomized and blind to treatment.
~All patients will have pretreatment Electrogram (ECG), serum biochemistry and serum Magnesium levels. Serum Magnesium levels will also be measured at 48 hours. Blood pressure, heart rate, respiratory rate and serious adverse events will be monitored at baseline, 15 minutes, and 12, 24 and 48 hours after infusion. Magnesium will be given intravenously with a loading dose of 4 g in 50 mL saline over a 15-minute period and 16 g in 100 mL over a 24-hour period in a continuous-infusion form.
~Follow-up visits will be conducted by the same investigators, and repeated scores on the NIH Stroke Scale will be obtained at 24 hours, 48 hours post admission and on the day of discharge."
15804586|NCT04412837|Drug|Topical CBD Patch|35 mg CBD patch
15804587|NCT04412837|Other|Placebo Patch|Identical patch without active ingredient.
15804588|NCT04412824|Drug|Intravenous blood draw|In addition to the oral delivery, an IV line will be placed for the purpose of drawing blood during the MRI session
15804589|NCT04412798|Other|orange juice concentrate|250mL of 100% orange juice made from concentrate
15804590|NCT04412798|Other|Sugar-sweetened orange-flavoured beverage|Sugar-sweetened orange-flavoured beverage, energy-matched to the orange juice condition
15804591|NCT04412798|Other|Whole orange juice with skin removed|Whole orange pieces with skin removed, energy-matched to the orange juice condition
15804592|NCT04412785|Drug|Cyclosporine|• The initial dose will be 9 mg/kg/day oral divided q12h. For IV, the dose will be 3mg/kg/day by continuous IV infusion.
15804593|NCT04412772|Drug|Tocilizumab|Participants will receive 1 dose of IV TCZ. 1 additional dose may be given if clinical symptoms worsen.
15804594|NCT04412772|Drug|Placebo|Participants will receive 1 dose of IV placebo matched to TCZ. Up to 1 additional dose may be given if clinical symptoms worsen.
15804595|NCT04412759|Other|microbial cellulose|polymer dressing synthesized in abundance with Acetobacter Xylinum
15804596|NCT04412746|Drug|MANAGEMENT OF COVID-19|"MANAGEMENT OF COVID-19 Oxygen therapy to maintain SpO2 target more than 94%. Low molecular weight heparin (LMWH) at preventive doses. Empirical antibiotic treatment.
~Specific treatment for COVID-19 (approved by Algerian Ministry of Health) First line: Hydroxychloroquin: 200 mg oral three times a day for 10 days, with association of Azithromycin 250 mg oral : 500 mg the first day and 250 mg once a day for 4 days. Sulfate de Zinc : 220 mg once a day for 5 days. Second line: Lopinavir/ritonavir capsule 200 mg/50 mg, oral 2 capsules each times, twice a day during 5 to 7 days.
~IF AGGRAVATION OR CRITICAL ILL CONDITION AT PRESENTATION Increase oxygenation flow. Consider Glucocorticoids. 3. Consider the diagnosis of pulmonary embolism and treat with LMWH at therapeutic doses.
~MANAGEMENT OF DIABETES Discontinue metformin. Start or adjust insulin doses according to personalized glycemic target of patient."
15804597|NCT04412733|Device|Therapeutic Pulsed Ultrasound|Patients in pulsed ultrasound group received pulsed ultrasound treatment (frequency: 1000 kHz, intensity: 0.5w/cm2, on-off ratio: 1:2). Pulsed ultrasound treatment were applied with 5-cm2 head Enraf-Nonius Sonopuls 434 ultrasound device.
15804598|NCT04412733|Device|Sham Ultrasound|Control group received sham ultrasound treatment
15804599|NCT04412720|Other|Aerobic and Breathing Exercises|Aerobic exercises will be performed on a treadmill, twice a week, totaling 20 sessions of 60 minutes each. The initial intensity will be 50% to 60% of maximum heart rate and the progression will take place according to the level of effort (Borg) in the last two sessions. In addition, following the aerobic training, Buteyko Breathing Technique also will be performed during 20 minutes each exercise, in the same treatment session. During the first two weeks, the patient will learn the technique supervised by a physical therapist. In addition, the patients will receive a breathing exercise booklet for in-home training. Before and after each session, patients will be evaluated in relation to blood pressure, heart rate, oxygen saturation and asthma symptoms.
15804600|NCT04412720|Other|Aerobic and Stretching Exercises|Aerobic exercises will be performed on a treadmill, twice a week, totaling 20 sessions of 60 minutes each. The initial intensity will be 50% to 60% of maximum heart rate and the progression will take place according to the level of effort (Borg) in the last two sessions. In addition, following the aerobic training, stretching exercises will be performing for major muscle groups, during 30 seconds each one. The patients will receive a stretching exercise booklet for in-home training.
15804601|NCT04412707|Drug|Melphalan-Flufenamide|Peripheral versus central administration
15804602|NCT04412707|Drug|Dexamethasone|Oral tablets
15804603|NCT04412694|Drug|Dexamethasone oral tablet 8mg (Dexamethasone Krka tablets(8mg), Warsaw, Poland).|Preoperative oral dexamathasone supplementation in a single dose of 8mg.
15804604|NCT04412694|Drug|Placebo oral sweetener (Clio tablets, sweetener with a dispenser, Instantina GES, Vienna, Austria).|Preoperative oral supplementation of sweetener in a single dose.
15804605|NCT04412694|Diagnostic Test|Preoparative blood laboratory tests|Preoperative parameters such as blood count, calcium, inorganic phosphates, albumin, alkaline phosphatase, C reactive protein, procalcitonin, 25-hydroxyvitamin D, fibrinogen, parathormone, magnesium, interleukin 1β, interleukin 6, interleukin 10, thyroid stimulating hormone, free thyroxine, free triiodothyronin will be measured in serum.
15804606|NCT04412694|Diagnostic Test|Postoperative laboratory blood tests at 6 hour|At 6 hour after surgery such parameters as blood count, calcium, inorganic phosphates, albumin, alkaline phosphatase, C reactive protein, procalcitonin, 25-hydroxyvitamin D, fibrinogen, parathormone, magnesium will be measured in serum.
15804607|NCT04412694|Diagnostic Test|Postoperative laboratory blood tests at 24 hour|At 24 hour after surgery such parameters as blood count, calcium, inorganic phosphates, albumin, alkaline phosphatase, C reactive protein, procalcitonin, 25-hydroxyvitamin D, fibrinogen, parathormone, magnesium, interleukin 1β, interleukin 6, interleukin 10 will be measured in serum.
15804608|NCT04412694|Diagnostic Test|Postoperative laboratory drainage fluid tests at 24 hour|At 24 hour after surgery such parameters as interleukin 1β, interleukin 6, interleukin 10 will be measured in drainage fluid.
15804609|NCT04412694|Procedure|Total thyroidectomy|Patients will undergo total thyroidectomy under general anesthesia.
15804610|NCT04412694|Other|Symptomatic hypocalcaemia at 6 hour|At 6 hour after surgery patients will be assessed for signs of hypocalcaemia.
15804611|NCT04412694|Other|Symptomatic hypocalcaemia at 24 hour|At 24 hour after surgery patients will be assessed for signs of hypocalcaemia.
15804612|NCT04412694|Other|Postoperative pain at 6 hour|At 6 hour after surgery the incidence and intensity of postoperative pain will be evaluated according to Visual Analogue Scale (VAS).
15804613|NCT04412694|Other|Postoperative pain at 24 hour|At 24 hour after surgery the incidence and intensity of postoperative pain will be evaluated according to Visual Analogue Scale (VAS).
15804614|NCT04412694|Other|Postoperative nausea and vomiting at 6 hour|At 6 hour after surgery the incidence and intensity of postoperative nausea and vomiting will be evaluated.
15804615|NCT04412694|Other|Postoperative nausea and vomiting at 24 hour|At 24 hour after surgery the incidence and intensity of postoperative nausea and vomiting will be evaluated.
15804616|NCT04412694|Other|Postoperative sore throat and hoarseness at 6 hour|At 6 hour after surgery the incidence and intensity of postoperative sore throat and hoarseness will be evaluated.
15804617|NCT04412694|Other|Postoperative sore throat and hoarseness at 24 hour|At 24 hour after surgery the incidence and intensity of postoperative sore throat and hoarseness will be evaluated.
15804618|NCT04412681|Diagnostic Test|Enhanced PE Screening|To better identify women at risk for pre-eclampsia during pregnancy.
15804619|NCT04412668|Drug|ATYR1923 1 mg/kg|1 mg/kg of ATYR1923 administered intravenously
15804620|NCT04412668|Drug|ATYR1923 3 mg/kg|3 mg/kg of ATYR1923 administered intravenously
15804622|NCT04412655|Device|Percutaneous Coronary Revascularization for STEMI|Percutaneous Mechanical Reperfusion for STEMI
15804623|NCT04412642|Drug|Methoxyflurane, MEOF|As soon as possible following enrollment and initial procedures, the patient will be supplied with a PENTHROX™ kit which includes one inhaler containing 3 mL of MEOF for pain management. A member of the research team will train the patient to self-administer MEOF. PENTHROX™ is an approved (trademarked) product in Canada and is commercially available in a combination blister pack with one 3 mL sealed bottle and one PENTHROX™ inhaler with the Activated Carbon (AC) chamber.
15804624|NCT04412629|Drug|Cabozantinib|Cabozantinib should be taken on an empty stomach (at least 1 hour before or 2 hours after eating) at the same time every day.
15804625|NCT04412629|Procedure|Blood for plasma biomarkers|Cycle 1 day 1, cycle 1 day 8, cycle 1 day 15, and day 1 of every cycle thereafter
15804626|NCT04412629|Procedure|Tissue biopsy|Baseline, before start of cycle 2, and time of progression
15804627|NCT04412616|Biological|ZZ06|"The phase I 3 + 3 study design was used in dose escalation from low dose to high dose to determine the MTD.Sequential assignment of Patient cohorts to one of five dose levels of ZZ06 : 0.03mg/kg,0.06mg/kg,0.12mg/kg,0.22mg/kg,0.39mg/kg,0.70mg/kg,1 mg/kg."
15804628|NCT04412603|Other|Conventional Mirror Therapy|The Conventional Mirror Therapy was carried out with a mirror box and the Mirror Therapy Virtual Reality was carried out with virtual reality glasses and mobile application: Mirror Therapy VR.
15804629|NCT04412590|Other|Vermont Family Based Approach|Comprehensive and individualized program to promote emotional health and wellbeing in families using evidence-based health promotion, prevention and intervention.
15804630|NCT04412590|Other|Treatment as Usual|Pediatric care as usual.
15804631|NCT04412577|Drug|TQB3473|TQB3473 tablets administered orally once. Then TQB3473 tablets administered orally, once daily in 28-day cycle after 3 days of first administration.
15804632|NCT04412564|Drug|TQ-B3101|TQ-B3101 is a ALK inhibitor.
15804633|NCT04412538|Biological|Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule|Two doses of low dosage(50U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28
15804634|NCT04412538|Biological|Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule|Two doses of low dosage(50U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14
15804635|NCT04412538|Biological|Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule|Two doses of medium dosage(100U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28
15804636|NCT04412538|Biological|Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule|Two doses of medium dosage(100U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14
15804637|NCT04412538|Biological|High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule|Two doses of high dosage(150U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28
15804638|NCT04412538|Biological|High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule|Two doses of high dosage(150U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14
15804639|NCT04412538|Biological|Placebo on a 0- and 28-day schedule|Two doses of placebo at the vaccination schedule of day 0,28
15804640|NCT04412538|Biological|Placebo on a 0- and 14-day schedule|Two doses of placebo at the vaccination schedule of day 0,14
15804641|NCT04412525|Device|vitrectomy (27G gauge or larger needle)|vitrectomy surgery for either floater removal or macular surgery, with or without combined cataract (phaco) surgery.
15804642|NCT04412512|Procedure|VATS approach|video-assisted thoracic surgery approach
15804643|NCT04412512|Procedure|Thoracotomy approach|
15804644|NCT04412486|Biological|COVID Convalescent Plasma|One unit of COVID Convalescent Plasma transfused on Day 0
15804645|NCT04412447|Device|Functional Electrical Stimulation|Electrical stimulation of motor-nerves innervating the musculature of the lower limb.
15804646|NCT04412434|Diagnostic Test|Electroencephalography (EEG)|"Electroencephalography (EEG) is a painless and harmless method to record the bioelectric activity of the brain. Clinically, EEG refers to the recording of the brain's spontaneous electrical activity over a period of time, as recorded from multiple electrodes placed on the scalp This method can be helpful in the diagnosis of many various brain diseases and pathological conditions.
~For the examination, electrodes are placed on the head, using a special harmless gel, similar to gel, used in ultrasonographic studies."
15804647|NCT04412421|Procedure|Gastric Bypass, Sleeve Gastrectomy|Lifelong vitamin and Mineral supplementation
15804648|NCT04412408|Drug|Sintilimab|"Sintilimab is administered every 21 days until the disease progresses or treatment is terminated due to unacceptable toxicity. For patients with clinical and radiologic benefits, treatment can last up to 2 years.
~Dose: 2 mg / kg intravenously for 60 min (± 10 min window)"
15804649|NCT04412395|Dietary Supplement|Lactoferrin (Apolactoferrin)|Apolactoferrin is an iron-free Lactoferrin (with very low iron saturation). Lactoferrin (Lf) is a natural glycoprotein that is found predominantly in milk. Lf represents a known component of the innate immune system present in neutrophil-specific granules and broadly distributed within the body fluids and exocrine secretions.
15804650|NCT04412395|Drug|Placebo of excipient(s) will be administered|Placebo of the equivalent excipient will be administered to placebo group
15804651|NCT04412382|Diagnostic Test|NETosis markers|"NETosis markers (Cf-DNA. MPO-DNA, Cit-H3) and the cytokines IL-6 and IL-1β will be analyzed from the subjects' plasma.
~Spittle sample (or bronchoalveolar fluid if necessary for diagnostic-therapeutic purposes) will be collected and the detection of NETs at electron microscopy will be assessed."
15804652|NCT04412369|Diagnostic Test|Non-invasive cardiac imaging|Cardiac MRI ± CT coronary angiography ± Cardiac PET/MRI (68Ga-DOTATATE or 18F-FDG)
15804653|NCT04412356|Procedure|Tracheotomy|Surgical procedure to secure airway
15804654|NCT04412343|Behavioral|Virtual Group Intervention|Participants will receive weekly exercise courses delivered virtually to a group of older adults. This intervention will last for 12 weeks. Participants in addition to participating in exercise will have designated time after each exercise class to socially connect. Participants in this condition will also receive a t-shirt.
15804655|NCT04412343|Behavioral|Personal Exercise Intervention|Participants will receive weekly exercise courses delivered virtually. These classes will be pre-recorded so the individual can complete sessions at any time that is convenient for them.
15804656|NCT04412330|Other|ICU Recovery + Physical Therapy|Physical therapy interventions will be supervised by a physical therapist (>20 years of experience in ICU and pulmonary rehabilitation). Potential interventions include endurance/aerobic training (treadmill training, upper and lower extremity ergometer, and recumbent step machine), upper and lower extremity resistance strength training, balance training, functional movement training, and education. If the interventions are providing in the home environment the exercises will be completed through Zoom, video communications app. Home-based interventions will include seated and standing exercise including resistance exercises (such as lifting small weights) and endurance (e.g. marching or stepping in place, repetitive sit-to-stand training). Physical therapist will provide verbal instructions for motivation and adherence to exercise interventions.
15804657|NCT04412304|Drug|Dose of Tinzaparin or Dalteparin|The patients will be categorised into three groups depending on initial regime of anticoagulants after arrival in the ICU.
15804658|NCT04412291|Drug|Anakinra Prefilled Syringe|A total dose of 400mg per day (divided in 4 doses of 100 mg iv every 6 hours) for 7 days.
15804659|NCT04412291|Drug|Tocilizumab Prefilled Syringe|8mg/kg for a single infusion iv up to max 800 mg. If no clinical response is obtained, another dose of 8mg/kg may be administered after earliest 2 days after inclusion with the following condition: The clinical symptoms are worsened (as assessed by decreasing PaO2/FiO2 and/or need of increased ventilatory support such as NIV, HFNC or mechanical ventilation).
15804660|NCT04412291|Drug|Standard-of-care treatment|"SOC according to local recommendations at the Karolinska University Hospital. Oxygen supplementation so to achieve SpO2>93%. Thrombosis prophylaxis (Fragmin or Innohep and Klexane® or new oral anticoagulants including dabigatran, apixaban or rivaroxaban).
~Steroids (Betapred 6 mg po) Broad spectrum antibiotics (only in arm B and C)"
15804661|NCT04412278|Other|Online Survey|Volunteer individuals enrolled the study after approval an online informed consent form. Sociodemographic data of the participants recorded as an online survey. Then, patient reported outcomes were used to assess physical activity level (International Physical Actvity Questionairre) and Exercise Benefits and Barriers (Exercise Benefits and Barriers Scale).
15804662|NCT04412265|Other|Relation between frailty and clinical outcomes in elderly patients with COVID-19.|"To evaluate whether a tool built to measure frailty in elderly patients hospitalized in COVID + hospital departments are more accurate in predicting clinical outcomes compared to a clinical evaluation based on age and comorbidity. If the assessment of fragility were actually more accurate, the tool developed could be implemented in hospitals to support the clinician 's choices regarding the roof of care and actions to be taken undertake to prevent deterioration."
15804663|NCT04412252|Drug|Tofacitinib|10 mg tofacitinib administered as two 5 mg tablets or solution taken orally twice daily for 14 days
15804664|NCT04412252|Other|Placebo|Tofacitinib-matching placebo administered as tablets or solution taken orally twice daily for 14 days
15804665|NCT04412239|Behavioral|Patient-centred advice on Telephone Consultation in TB Patients:|The primary aim was to assess the efficiency and the satisfaction of the telephone consultation. The COVID-19 pandemic might be an opportunity to review and refine our practices in TB care. For the follow-up of selected patients, telephone consultations may be efficient and cost effective.
15804666|NCT04412226|Device|aerosol box|The aerosol box is a barrier that protects the staff against the aerosols during the aerosol generating procedures like endotracheal intubation. It is a transparent cube that covers the patient's head during the endotracheal intubation. Operator can intubate the patient through the two holes for arms.
15804667|NCT04412226|Device|transparent sheet|The transparent sheet is a barrier that protects the staff against the aerosols during the aerosol generating procedures like endotracheal intubation. It is a transparent cover that covers the patient's head and body during the endotracheal intubation. Operator can intubate the patient through the space under the cover
15804668|NCT04412213|Other|Stuttering severity instrument for school-age children (SSI-3 Arabic version)|Stuttering severity instrument for school-age children (SSI-3 Arabic version) for measuring stuttering severity Stanford Binet test version 4 to evaluate the mentality (IQ)
15804669|NCT04412200|Device|Hyperbaric oxygen chamber (HBOC)|HBOC group will receive 100% oxygen at 2 ATA for 90 min with 5 min air breaks every 20 min at each session. Intensive management period includes 60 daily sessions, 5 days per week within 12 weeks,
15804670|NCT04412200|Device|sham Hyperbaric oxygen chamber (HBOC)|sham Hyperbaric oxygen chamber (HBOC)
15804671|NCT04412187|Diagnostic Test|[18F]-GE-180 PET|serial [18F]-GE-180 PET imaging to assess microglia activation
15804672|NCT04412187|Diagnostic Test|3T MRI|serial MR imaging (i) to determine infarct characteristics, (ii) to identify gray and white matter structures connected to the infarct, (iii) to detect incident lesions, and (iv) to quantify longitudinal changes e.g. of cortical thickness
15804673|NCT04412187|Diagnostic Test|immune cell profiling in blood|Cell-specific cytokine profiles, markers of activation, terminal differentiation as well as cytotoxicity will be assesses using flow cytometry.
15804674|NCT04412174|Biological|GC022F|GC022F is a bispecific CAR-T cell immunotherapy that targeted CD19 and CD22. The dosage ranges from 3×10^5 to 1×10^6 CAR+T/Kg.
15804675|NCT04412161|Procedure|Liver transplantation|Living donor liver transplantation
15804676|NCT04412148|Drug|Triamcinolone Acetonide|intralesional injection of triamcinolone acetonide every 2 weeks for 6 sessions
15804677|NCT04412148|Other|saline|intralesional injection of saline
15804678|NCT04412135|Other|spirituality|Patients will take three questionnaires (FACIT-Sp, Euroqol 5 dimensions and ESAS)
15804679|NCT04412122|Other|Kinesio Taping|In the study, kinesio taping method was applied immediately after the surgical operation. The tape was applied on one centimeter above and one centimeter below the incision site with a 25% tension in web cutting technique (Figure 1.). In order to facilitate gas passing and defecation, the tape was applied around the navel in the Y shape with a 25% tension (Figure 2). No tension was applied to the starting and ending points of the tape. Pain level was evaluated with VAS before and after 45 minutes of tape application. Pain level was evaluated by VAS on the 1st, 2nd and 3rd postoperative day. Kinesio tape remained on women for 72 hours.
15804680|NCT04412122|Other|Breathing Exercise|Before the surgery, researchers informed the women about the purpose and benefits of breathing exercises and showed the how to perform them. Breathing exercises were performed 3 times a day for 30 minutes on the first, second and third days. 15 minutes of exercises were done while sitting and in a comfortable position and 15 minutes while mobilizing. Pain levels of women were evaluated with VAS before and after 30 minutes of breathing exercises.
15804681|NCT04412122|Other|Kinesio Taping+Breathing Exercise|In the study, kinesio taping method was applied immediately after the surgical operation. . Pain level was evaluated with VAS before and after 45 minutes of tape application.Breathing exercises were performed 3 times a day for 30 minutes on the first, second and third days. 15 minutes of exercises were done while sitting and in a comfortable position and 15 minutes while mobilizing. Pain levels of women were evaluated with VAS before and after 30 minutes of breathing exercises.
15804682|NCT04412122|Other|Control Group|No intervention was performed to reduce pain in the control group.
15804683|NCT04412109|Procedure|thoracic epidural catheterization|thoracic epidural catheterization for postoperative pain control
15804684|NCT04412096|Drug|Timolol 0.5% ophthalmic solution|1 drop BID
15804685|NCT04412096|Drug|Latanoprost 0.005% Ophthalmic Solution|1 drop QD
15804686|NCT04412083|Behavioral|PPA Tele-Savvy Pilot Intervention|We will engage PPA caregivers in the process of adapting the existing Tele-Savvy program to fit their needs and then pilot test the adapted PPA Tele-Savvy program.
15804687|NCT04412057|Drug|CERC-002|Administered once subcutaneously at 16 mg/kg dose up to a maximum dose of 1200 mg.
15804688|NCT04412057|Drug|Placebo|Administered once subcutaneously
15804689|NCT04412044|Drug|Mepolizumab Injection [Nucala]|Patients receive monthly injection with 100 mg mepolizumab
15804690|NCT04412031|Other|non applicable|non applicable
15804691|NCT04412018|Drug|Icosapent ethyl|Icosapent ethyl (4 g BID for 3 days, then 2 g BID for the subsequent 11 days)
15804692|NCT04412005|Other|No intervention|No intervention
15804693|NCT04411992|Device|Vibrating Device|The device used for the vibration application was produced to control pain and distract attention by providing vibration of 150 at 183 Hz (9000-11,000/min). The device is used again by being cleaned with 70% alcohol. The device was placed put 3 cm above the injection site. It should be ensured to completely contact with skin. Vibration was applied on the site for 3 minutes before injection
15804694|NCT04411979|Other|treatment-as-usual plus aerobic walking|aerobic walking
15804695|NCT04411966|Diagnostic Test|18F-fluorothymidine|Patients receive fluorothymidine F-18 IV over 1 minute and undergo PET scan over 60 minutes at least 10 days prior to systemic chemotherapy, and at least 10 days after first and second cycles of systemic chemotherapy.
15804696|NCT04411953|Drug|Haloperidol Tablets, Mylan Pharmaceuticals Inc.|single dose, 2 mg Haloperidol tablet
15804697|NCT04411953|Drug|Haloperidol Tablets, Cycle Pharmaceuticals Ltd|single dose, 2 mg Haloperidol tablet
15804698|NCT04411940|Drug|Haloperidol Tablets, Mylan Pharmaceuticals Inc.|single dose, 2 mg Haloperidol tablet
15804699|NCT04411940|Drug|Haloperidol Tablets, Cycle Pharmaceuticals Ltd|single dose, 2 mg Haloperidol tablet
15804700|NCT04411927|Other|assessment of postural stability|assessment of postural stability
15804701|NCT04411914|Drug|Clavulanic Acid Only Product|Drug will be given in 250mg capsules.
15804702|NCT04411914|Other|Placebo|Placebo
15804703|NCT04411901|Drug|Cholecalciferol (vitaminD3)|Theraputic vitamin D3 for CF and non CF bronchiectasis children
15804704|NCT04411888|Other|observation|observation
15804705|NCT04411875|Drug|Amlodipine 10 mg|The subjects randomly received single oral administration of amlodipine 10 mg.
15804706|NCT04411875|Drug|Levamlodipine 5 mg|The subjects randomly received single oral administration of levamlodipine 5 mg.
15804707|NCT04411862|Dietary Supplement|Phosphatidyl Choline|2.1 g Phosphatidylcholine daily in addition to lifestyle modification
15804708|NCT04411862|Behavioral|Lifestyle modification|Lifestyle modification and health education by Clinical Pharmacist
15804709|NCT04411849|Other|Best Practice|Receive usual care
15804710|NCT04411849|Procedure|HPV Self-Collection|Receive HPV self-testing intervention
15804711|NCT04411849|Other|Informational Intervention|Receive information about cervical cancer
15804712|NCT04411849|Other|Medical Chart Review|Ancillary studies
15804713|NCT04411849|Behavioral|Patient Navigation Program|Receive telephone-based patient navigation
15804714|NCT04411849|Other|Survey Administration|Ancillary studies
15804715|NCT04411836|Drug|Tafenoquine|patients are treated with schizontocidal treatment plus a single dose of Tafenoquine (TQ).
15804716|NCT04411836|Drug|Primaquine|patients are treated with schizontocidal treatment plus high dose PQ (total dose 7 mg/kg) unsupervised over 7 days (PQ7)
15804717|NCT04411823|Device|EndoFLIP measurement|EndoFLIP device can measure gastroesophageal junction distensibility index and esophageal contractile pattern. It is performed during endoscopy.
15804718|NCT04411810|Device|Nevisense 3.0|Nevisense, an AI-based point-of-care system for the non-invasive evaluation of irregular moles remains the only FDA approved system available for melanoma detection in the US. Nevisense 3.0 will be used as a one-time exposure of <8 seconds per lesion. Disposable electrodes that contact the participant are 5mm x 5mm in size. Nevisense 3.0 measures electrical impedance of skin lesions and provides an output called the electrical impedence spectroscopy (EIS) score. Electrical impedance is a measure of a material's overall resistance to the flow of alternating electric currents of various frequencies. The principle is that electrical impedance is different in normal versus abnormal tissue.
15804719|NCT04411810|Device|Dermlite Cam|Dermlite Cam is a digital camera that captures images of the skin under cross-polarized and non-polarized light and is 510(k) exempt. The DermLite Cam device appears as a single piece camera with a charging cable and USB computer cable. As part of the camera unit, an extensor arm exists to allow for the capture of standardized clinical images. The DermLite Cam will be used to acquire 3 images of <5 seconds per lesion (one clinical, one polarized dermoscopic, and one non-polarized dermoscopic).
15804720|NCT04411810|Procedure|Skin biopsy|A skin biopsy is a small procedure that removes a sample of skin from the surface of the body. The method utilized will be either a shave or punch technique. The maximum size of a punch biopsy will be 6mm and these wounds are generally closed with no more than 2-3 sutures. A skin biopsy takes <15 minutes including preparation time, administration of intradermal anesthesia using lidocaine 1% with epinephrine 1:100,000, removal of the skin sample, achievement of hemostasis, dressing the wound, and providing instructions for home care. Samples will be placed formalin for routine processing.
15804918|NCT04410328|Drug|Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally AND Standard of care|Participants in the experimental group will receive Dipyridamole ER 200mg/ Aspirin 25mg orally/enterally (if they have a feeding tube), 2 times daily starting on the day of enrollment for a total of 2 weeks.
15804721|NCT04411771|Behavioral|Brief interventions|'Brief Interventions' (BI) is a generic term for a multitude of tools and interventions used in patient visits within PCBH. BI start immediately at the initial consultation, which ends with a personally tailored and evidence-informed plan adjusted to the patient's context. As such, there is no separation between assessment and intervention. The interventions within BI often have their foundation in CBT, ACT or MI. The common theme is that they are principle-based rather than manual-based and focus on behavioral change in relation to a problem that is perceived both possible to affect and relevant to the patient, rather than focusing on a specific diagnosis or condition. Follow-up appointments are scheduled flexibly depending on the patient's perceived need. Usually a BI treatment consists of 1-4 appointments with several weeks apart and ends when the patient feels that they are moving in the right direction.
15804722|NCT04411771|Behavioral|Guided self-help CBT|The patient receives a previously scientifically evaluated CBT-based self-help book for one of the following conditions: depression, generalized anxiety disorder, panic disorder, social anxiety, health anxiety, insomnia, or stress/burnout. The therapist support consists of 3-6 contacts throughout the 6-12 weeks long intervention period as decided by the clinician and patient together, as long as at least one and not more than three are physical visits at the center and the rest via phone, video conferencing, or secure internet messages. Clinicians delivering shCBT will need four days of reading and two days of training to be able to make initial assessments and problem profiling and use the self-help books.
15804723|NCT04411758|Dietary Supplement|Propolis|The patients will receive 20 drops of green propolis alcohol extract diluted in 1 glass of water.
15804724|NCT04411745|Other|No intervention, observational study|
15804725|NCT04411732|Device|MyotonPro|Measurement of relaxation time, stiffness and elasticity of the following muscles, using the MyotonPro® device: on both sides thenar and hypothenar, m. biceps brachii, m. triceps brachii, m. deltoideus, m. quadriceps femoris, m. tibialis anterior and gastrocnemius muscles.
15804726|NCT04411732|Diagnostic Test|Six-minute walk test|The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. The individual is allowed to self-pace and rest as needed as they traverse back and forth along a marked walkway. The 6MWT has been used with a variety of other conditions than the chronic obstructive pulmonary disease (COPD) such as heart failure and stroke and is widely used in neuromuscular diseases. The six-minute-walk-test will be conducted as recommended by the American Thoracic Society. In this study, the six-minute-walk test will be performed once on visit 1 to detect the impact of muscle weakness, muscle stiffness and myotonia on muscular endurance.
15804727|NCT04411732|Diagnostic Test|Semiquantitative muscle ultrasound|Muscle ultrasound is an ideal imaging modality that allows for atraumatic, noninvasive, radiation-free point-of-care neuromuscular imaging. Muscular dystrophies are typically associated with an increase in the echogenicity from the muscle substance, distal attenuation of muscle echo and a corresponding loss of bone echo. Spinal muscular atrophies and neuropathies also showed an increase in muscle echo along with atrophy of the muscle and increase in depth of subcutaneous tissue, but a persisting bone echo. In several other myopathies, similar changes are seen. In semi-quantitative muscle ultrasound, muscle intensity will be documented using the 4-point Heckmatt score. In addition to that, cutis, subcutaneus fat and muscle will be measured in mm.
15804728|NCT04411732|Diagnostic Test|Hand-held Dynamometry of muscle strength|Muscle strength will be assessed by handheld dynamometry using the MicroFET2 myometer, produced by Hoggan Health Industries. This test is widely used in patients with neuromuscular diseases. To perform a test, the examiner holds the dynamometer stationary while the patient exerts a maximal force against the dynamometer. The patient makes a gradual increase in force and then completes an isometric hold for 4-5 seconds. The following muscle groups will be tested: Arm abduction, elbow flexion, elbow extension, knee extension, knee flexion, foot extension, foot flexion.
15804729|NCT04411719|Device|Electric stimulation device(Neuroconn)|Real electric stimulation
15804730|NCT04411706|Drug|Sintilimab Combined With Apatinib and Capecitabine|"Drug: Sintilimab 200mg (3mg/kg for underweight patients) intravenously, every 21 days for a cycle;
~Drug: Apatinib,250mg po qd, for continuous medication;
~Drug: Capecitabine,1000mg/m2 po bid, d1-d14, every 21 days for a cycle;"
15804731|NCT04411693|Drug|Dexamethasone implant|A sustained-release drug delivery system containing 0.7 mg of Dexamethasone. Implant is administered by intravitreal injection.
15804732|NCT04411693|Drug|Aflibercept|A single dose, 2mg, drug administered by intravitreal injection.
15804733|NCT04411680|Drug|Sargramostim|Sargramostim is a recombinant human granulocyte-macrophage colony stimulating factor (rhu-GM-CSF). Dosage for inhaled sargramostim: 125 mcg twice a day. Dosage for intravenous sargramostim: 125mcg/m2/day given over a 4 hour period.
15804734|NCT04411680|Drug|Standard of care|Standard of care for COVID-19
15804735|NCT04411667|Drug|Octagam|Standard of Care plus Octagam infusion for 3 days.
15804736|NCT04411654|Biological|PR001|Participants will receive a single dose of PR001 administered intracisternally.
15804737|NCT04411654|Drug|Methylprednisolone|Single IV pulse administered as concomitant medication.
15804738|NCT04411654|Drug|Sirolimus|Loading dose, followed by maintenance doses, followed by dose tapering; administered as concomitant medication.
15804739|NCT04411654|Drug|Prednisone|Administered orally as concomitant medication, followed by dose tapering.
15804740|NCT04411641|Drug|Tolebrutinib|Pharmaceutical form: Film-coated tablet Route of administration: Oral
15804741|NCT04411641|Drug|Placebo to match Tolebrutinib|Pharmaceutical form: Film-coated tablet Route of administration: Oral
15804742|NCT04411628|Drug|LY3819253|Administered IV.
15804743|NCT04411628|Drug|Placebo|Administered IV.
15804744|NCT04411615|Drug|Omega 3|rTG form Omega-3
15804745|NCT04411602|Drug|SARS-CoV-2 plasma|To determine feasibility of convalescent plasma for treating patients in the ICU with COVID-19.
15804746|NCT04411589|Device|magnifying endoscopy with optical enhancement system|A complete screening examination was first performed with white light endoscopy. Additionally, the types of endoscopic GIN and EGC were recorded according to the Paris Classification. After visualization in white light mode, the stomach was reinspected by using OE mode2. Then, in vivo diagnoses of lesions were made by using OE mode1 according to VS theory. For all suspicious areas, a minimum of one biopsy specimens were first taken in a targeted fashion.
15804919|NCT04410328|Other|Standard of care|Participants will receive standard care starting on the day of enrollment for a total of 2 weeks.
15804747|NCT04411589|Device|white light endoscopy system|A complete screening examination was first performed with white light endoscopy. Additionally, the types of endoscopic GIN and EGC were recorded according to the Paris Classification. For all suspicious areas, a minimum of one biopsy specimens were first taken in a targeted fashion.
15804748|NCT04411576|Diagnostic Test|Throat swab sample for measuring current infection with SARS-CoV-2|Throat sample taken by the study participant to be analyzed with RT PCR for the presence of SARS-CoV-2 viral nucleic acids.
15804749|NCT04411576|Diagnostic Test|Blood sample for serology to measure past infection with SARS-CoV-2|Blood samples for serology to be analyzed for the presence of SARS-CoV-2 antibodies.
15804750|NCT04411563|Other|Taking biological samples|Taking blood samples for biochemical and epigenetic analysis
15804751|NCT04411550|Drug|HLX11|healthy volunteers receive HLX11 (420mg) once
15804752|NCT04411550|Drug|CN-Perjeta(Pertuzumab)|healthy volunteers receive CN-Perjeta (420mg) once
15804753|NCT04411550|Drug|EU-Perjeta(Pertuzumab)|healthy volunteers receive EU-Perjeta (420mg) once
15804754|NCT04411550|Drug|US-Perjeta(Pertuzumab)|healthy volunteers receive US-Perjeta (420mg) once
15804755|NCT04411537|Drug|PD-1 antibody|Before neo-CRT: 2 cycles of PD-1 antibody, 240mg d1 q2w. After neo-CRT: 3 cycles of PD-1 antibody, 240mg d1 q2w.
15804756|NCT04411537|Drug|Capecitabine|During neo-CRT: 625mg/m2 bid Monday-Friday per week
15804757|NCT04411537|Drug|Irinotecan|During neo-CRT: 80mg/m2 qw (UGT1A1*28 6/6) or 65mg/m2 qw (UGT1A1*28 6/7)
15804758|NCT04411537|Radiation|Neoadjuvant Radiotherapy|IMRT DT: 50Gy/25Fx
15804759|NCT04411524|Drug|PD-1 antibody|Before neo-CRT: 2 cycles of PD-1 antibody After neo-CRT: 3 cycles of PD-1 antibody
15804760|NCT04411524|Drug|Capecitabine|During neo-CRT: 625mg/m2 bid Monday-Friday per week
15804761|NCT04411524|Drug|Irinotecan|During neo-CRT: 80mg/m2 qw (UGT1A1*28 6/6) or 65mg/m2 qw (UGT1A1*28 6/7)
15804762|NCT04411524|Radiation|Neoadjuvant Radiotherapy|IMRT DT: 50Gy/25Fx
15804763|NCT04411511|Other|Exposure to the Dutch measures due to the Covid-19 pandemic.|Several measures are taken in The Netherlands, due to the Covid-19 virus and pandemic. For example, closure of schools and sportclubs, and advices to stay at home as much as possible. During the pandemic, several measures also will be scaled down.
15804764|NCT04411498|Diagnostic Test|Fibromyalgia diagnosis in patients with SSc|American College of Rheumatology (ACR) FMS diagnostic criteria set:It is evaluated by the common pain index [WPI] and symptom severity (SS) scale [19]. Diffuse pain index [WPI]; It is a scale that can be scored between 0-19 and obtained by indicating the aching regions of the patient during the last 1 week. Right shoulder, left shoulder, right hip [gluteal region], left hip [gluteal region], left chin, right chin, left upper arm, left lower arm, right upper arm, right lower arm, left upper leg, left lower leg, includes right upper leg, right lower leg, chest, neck, abdomen, upper back, lower back. Symptom Severity Scale [SSS]; evaluates weakness, tired awakening and cognitive functions. In addition, muscle pain, weakness, irritable bowel syndrome, memory problems, headache, abdominal pain, numbness, dizziness, insomnia, depression, constipation, irritability, dry mouth etc. It also evaluates somatic symptoms.
15804765|NCT04411485|Other|Sexual dysfunction|Sexual dysfunction will be determined with separate scales for women and men
15804766|NCT04411472|Biological|Recombinant human alkaline phosphatase|patients with SA-AKI are randomly assigned in a 1:1 ratio to either placebo or 1.6 mg/kg recAP.
15804767|NCT04411472|Other|Placebo|Placebo
15804768|NCT04411459|Other|Invasive mechanical ventilation|Invasive mechanical ventilation for respiratory failure associated to COVID-19 pneumonia
15804769|NCT04411446|Drug|Vitamin D|5 capsules of 100.000 UI Vitamin D orally given all at once. One dose.
15804770|NCT04411446|Drug|Placebo|5 capsules of containing placebo orally given all at once. One dose.
15804771|NCT04411433|Drug|Favipiravir (3200 mg + 1200 mg)|"Dosage and method of administration: in a regimen of 2x1600 mg (oral) loading dose on day-1 followed by 1200 mg maintenance dose (2x600 mg, 2 times daily) on day-2 to day-5 (5 days in total).
~The treatment duration may be extended up to 14 days with the evaluation of principle investigator."
15804772|NCT04411433|Drug|Favipiravir (3600 mg + 1600 mg)|"Drug: Favipiravir (3600 mg + 1600 mg) Dosage and method of administration: in a regimen of 2x1800 mg (oral) loading dose on day-1 followed by 1600 mg maintenance dose (2x800 mg, 2 times daily) on day-2 to day-5 (5 days in total).
~The treatment duration may be extended up to 14 days with the evaluation of principle investigator."
15804773|NCT04411433|Drug|Favipiravir (3200 mg + 1200 mg) combined with Hydroxychloroquine|"Hydroxychloroquine Dosage and method of administration: in a regimen of 2x400 mg (oral) loading dose on day-1 followed by 400 mg maintenance dose (2x200 mg oral, 2 times daily) on day-2 to day-5 (5 days in total).
~Favipiravir Dosage and method of administration: in a regimen of 2x1600 mg (oral) loading dose on day-1 followed by 1200 mg maintenance dose (2x600 mg, 2 times daily) on day-2 to day-5 (5 days in total). The treatment duration may be extended up to 14 days with the evaluation of principle investigator."
15804774|NCT04411433|Drug|Favipiravir (3200 mg + 1200 mg) combined with Azithromycin|"Azithromycin Dosage and method of administration: in a regimen of 1x500 mg (oral) loading dose on day-1 followed by 250 mg maintenance dose (oral daily) on day-2 to day-5 (5 days in total).
~Favipiravir Favipiravir Dosage and method of administration: in a regimen of 2x1600 mg (oral) loading dose on day-1 followed by 1200 mg maintenance dose (2x600 mg, 2 times daily) on day-2 to day-5 (5 days in total). The treatment duration may be extended up to 14 days with the evaluation of principle investigator."
15804775|NCT04411433|Drug|Hydroxychloroquine|"Dosage and method of administration for patients with mild possible or confirmed COVID-19 pneumonia (no severe pneumonia symptoms): in a regimen of 2x400 mg (oral) loading dose on day-1 followed by 400 mg maintenance dose (200 mg oral 2 times daily) on day-2 to day-5 (5 days in total).
~Dosage and method of administration for patients with uncomplicated possible or confirmed COVID-19: in a regimen of 400 mg (200 mg oral 2 times daily) throughout 5 days (5 days in total)."
15804808|NCT04411212|Drug|Granulocyte colony-stimulating factor and platelet-rich plasma group|Antagonist protocol is used . Oocyte retrieval under transvaginal ultrasound guidance is performed 34 to 36 hours after HCG administration. Autologous platelet-rich plasma is prepared from the blood using the two step centrifuge process. Under ultrasound guidance and complete aseptic procedures, 1 ml of the PRP is infused inside the uterus while performing the mock embryo transfer. Moreover, G-CSF (Filgrastim®, 300μg/0.5ml) is injected subcutaneously. G-CSF is injected weekly until the 12th gestation week or negative pregnancy test.
15805523|NCT04405206|Procedure|Total Mesorectal Excision|Standard TME surgery openly or laporoscopically
15804776|NCT04411433|Drug|Hydroxychloroquine combined with Azithromycin|"Drug: Hydroxychloroquine combined with Azithromycin Hydroxychloroquine Dosage and method of administration for patients with mild possible or confirmed COVID-19 pneumonia (no severe pneumonia symptoms): in a regimen of 2x400 mg (oral) loading dose on day-1 followed by 400 mg maintenance dose (2x200 mg oral, 2 times daily) on day-2 to day-5 (5 days in total).
~Hydroxychloroquine Dosage and method of administration for patients with uncomplicated possible or confirmed COVID-19: in a regimen of 400 mg (2x200 mg oral, 2 times daily) throughout 5 days (5 days in total).
~Azithromycin Dosage and method of administration: in a regimen of 1x500 mg (oral) loading dose on day-1 followed by 250 mg maintenance dose (oral daily) on day-2 to day-5 (5 days in total)."
15804777|NCT04411420|Behavioral|Pain modulation with physical pain treatment|Examples of pain modulation with physical pain treatment include spinal manipulation, massage, or transcutaneous electrical nerve stimulation
15804778|NCT04411420|Behavioral|Telephone delivered self-management counseling for increasing physical activity|Centrally located physical therapy assistants will provide six weeks of telehealth consults to increase physical activity for the patient
15804779|NCT04411420|Behavioral|Telephone delivered behavioral treatment for participants with high risk for continued disability|Patients with a higher risk of developing chronic or persistent back pain will be identified using the nine question risk stratification start back screening tool (SBST) and will receive six additional weeks of physical activity instructions and additional pain modulation treatments as needed.
15804780|NCT04411420|Behavioral|Patient preference treatment protocol|the pain navigator will work through a shared decision making process with the patient to determine the preferred treatment protocol
15804781|NCT04411420|Behavioral|Nonpharmacological guideline adherent treatment protocol|the pain navigator will select only nonpharmacological guideline adherent treatment options for the patient
15804782|NCT04411420|Behavioral|Facilitated referrals to existing VA or non-VA pain management resources|the pain navigator will work with the referring physician to select only existing VA or non-VA pain management resources for the patient.
15804783|NCT04411407|Device|PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order|PROM registration via the DANBIO WebApp and the outpatient touchscreen in a randomised order
15804784|NCT04411394|Other|Questionnaire|Body Perception Questionnaire and Hospitalized Anxiety and Depression Scale
15804785|NCT04411381|Other|Telemedicine|Telemedicine associated with dried blood spot testing at home for RNA test to sustained virological response determination
15804786|NCT04411355|Dietary Supplement|control by dietitian|
15804787|NCT04411355|Other|Exercise programs|In line with the address information of the intervention patients, purpose/content of the study was discussed with the gyms of municipalities and patients were made to benefit from these facilities for free. For the patients preferring private gyms, it was ensured that discounts were made for the patients.
15804788|NCT04411355|Behavioral|control by psychiatrist|The psychiatrist assessed the suitability of the patients to the study, assessed the patients having adaptation problems with respect to lifestyle changes in monthly controls and also played roles in teaching the coping methods to patients and applying and interpreting the hospital anxiety and depression scale.
15804789|NCT04411342|Diagnostic Test|Albumin creatinine ratio|normal range of albumin in urine in patients with type 2 diabetes
15804790|NCT04411329|Drug|Bupivacaine|local anesthetics, steriod, alpha 2 blockers
15804791|NCT04411329|Drug|Dexamethasone|dexamethazone
15804792|NCT04411329|Drug|Dexmedetomidine|dexmedetomidine
15804793|NCT04411329|Drug|Hyalouridinase|hyalouridinase
15804794|NCT04411316|Combination Product|Catheter directed thrombolysis plus anticoagulation|"Patients will be randomized to pharmacomechanical catheter directed thrombolysis plus anticoagulation.
~PCDT will be AngioJet along with alteplase."
15804795|NCT04411316|Drug|Anticoagulation|Patients will receive anticoagulation alone. Anticoagulation will be heparin only.
15804796|NCT04411303|Behavioral|Step length biofeedback|Participants will be provided with visual feedback of their right and left step lengths on a screen in front of a treadmill.
15804797|NCT04411303|Behavioral|Propulsive force biofeedback|Participants will be provided with real-time visual feedback of anterior-posterior ground reaction forces of the paretic limb during stance phase on a screen in front of a treadmill.
15804798|NCT04411303|Behavioral|Interlimb asymmetry biofeedback|Participants will be provided with visual feedback of stride-by-stride values of their interlimb asymmetry on a screen in front of a treadmill.
15804799|NCT04411303|Behavioral|Aerobic intensity-based walking|Participants will walk at three different aerobic intensities. Aerobic intensity will be set based on target heart rate zones calculated with the Karvonen Formula. For low intensity, participants will walk at 30-40% intensity. In moderate intensity conditions, participants will walk at a 50-60% intensity level. In vigorous intensity conditions, participants will walk at an 70-80% intensity level. Aerobic intensity will be manipulated by changing walking speed.
15804800|NCT04411290|Procedure|Total thyroidectomy (TT)|Final total thyroidectomy histopathology report should be available for correlations with preoperatively determined malignancy predictive factors, Bethesda (cytology) and TI-RADS (ultrasound findings)
15804801|NCT04411277|Device|Application of the FreeStyle Libre Flash Glucose CGM.|Assessment of glycemic control and hypoglycemia, adherence to therapy and CGM use.
15804802|NCT04411277|Diagnostic Test|InBody 270 multifrequency bioimpedance|analysis of body composition to calculate appendicular skeletal muscle.
15804803|NCT04411264|Device|virtual reality|Use of a virtual reality headset while caring for chronic wound dressings
15804804|NCT04411251|Behavioral|Nature-near integrative day care unit programme|Interventions based on the Mindfulness-Based Stress Reduction (MBSR) programme and complementary medicine
15804805|NCT04411251|Behavioral|Conventional integrative day care unit programme|Interventions based on the Mindfulness-Based Stress Reduction (MBSR) programme and complementary medicine
15804806|NCT04411238|Other|interview|interview
15804807|NCT04411225|Drug|Cannabidiol oral solution|Both the active drug (cannabidiol) and placebo will be in oral solution.
15804809|NCT04411212|Other|Control group|Antagonist protocol is used . Oocyte retrieval under transvaginal ultrasound guidance is performed 34 to 36 hours after HCG administration. Mock embryo transfer is performed without injecting anything inside the uterus.
15804920|NCT04410315|Other|Serum-lactate < 2,2 mmol/L|Bloodgas analysis every hour from start surgery until recovery ward discharge
15804810|NCT04411199|Drug|D-PLEX|D-PLEX is a new formulation of extended release of Doxycycline. Each 5g D-PLEX vial contains 54.6mg Doxycycline free base (1.09%), which is equivalent to 63mg Doxycycline hyclate (1.26%). D-PLEX is supplied as a sterile powder to be reconstituted to paste in the operating room, using standard aseptic techniques and is intended for single administration. The non-active components of the extended release antibiotic formulation are β Tri-Calcium polymer and a lipid matrix. All formulation components are biodegradable.
15804811|NCT04411199|Other|Standard of Care (SoC)|prophylactic, pre-operation per institution guidelines
15804812|NCT04411186|Procedure|Standard Enhanced Recovery After Surgery (ERAS) Protocol|Subjects receive standard MUSC ERAS protocol - fluid intake, hydration, anti-emetics, pain control, and several other considerations.
15804813|NCT04411186|Procedure|ERAS and 5 Lung Protective Interventions|"Subjects will receive the standard MUSC ERAS protocol - fluid intake, hydration, anti-emetics, pain control, and several other considerations. The subject will also receive the following lung protective interventions:
~Pressure control ventilation-volume guaranteed (PCV-VG) ventilation at approximately 7cc/kg of predicted body weight (derived from combination of sex and height) Positive end-expiratory pressure (PEEP) 7cm H2O5 Immediately post intubation recruitment breath (30cm water for 30 seconds) Every 1 hour recruitment breath (30cm water for 30 seconds) 40% FIO2 initially - titrate up as necessary to maintain SPO2 >94%"
15804814|NCT04411173|Dietary Supplement|Whey Protein|Each condition (both rice and whey protein) match in color, flavor, and serving size.
15804815|NCT04411160|Drug|Vitamin C|4 gram of vitamin c slowly intravenous once daily for 4 days duration.
15804816|NCT04411160|Drug|Nitric Oxide|nitric oxide stared by 50 parts/billion(ppb) as starting dose titrated according to patient's saturation reaching to 90 ppb as a maximum dose
15804817|NCT04411160|Device|ventilators|All selected patients received conventional ventilation with protective lung strategy for 10 days with Controlled mechanical ventilation mode(CMV), fraction inspired oxygen (FIO2) of 100%, Positive end expiratory pressure(PEEP) of 10 cm H2O or more to achieve target arterial oxygen saturation(SPO2) of 90%
15804818|NCT04411134|Biological|E7 TCR|Approximately 3x10^8 or 1.5x10^9 E7 TCR T cells will be injected on day 0 and 1.5x10^9 E7 TCR T cells on day 31 (2 escalating dose levels)
15804819|NCT04411108|Other|Kaia Back Pain App|The Kaia Back Pain App provides instructions on exercise execution to participants for one week
15804820|NCT04411108|Other|Physiotherapist Exercise Instructions and written handouts|Participants will be instructed by physiotherapists in exercise execution and receive handouts and exercise for one week
15804821|NCT04411095|Other|Measuring thoracic rotation mobility|Measuring the thoracic rotation mobility with a goniometer, from a standardized position
15804822|NCT04411082|Drug|IMR-687|Oral administration of once daily IMR-687
15804823|NCT04411082|Drug|Placebo|Oral administration of once daily Placebo
15804824|NCT04411069|Drug|Droperidol|Pacients who had nausea and vomiting induced by chemotherapy will receive three anti emetic drugs: 4mg dexametasone, 4 mg ondansetron and 0,625 mg droperidol
15804825|NCT04411056|Other|Barrier box|Placement of barrier box ( a plastic box for shielding)
15804826|NCT04411043|Behavioral|Molecular caracterization|Prospective and retrospective study evaluating the epidemiological, clinical, molecular and therapeutic data of prolymphocytic leukemias T
15804827|NCT04411030|Drug|ASTX660|Form: capsule; Route of administration: oral
15804828|NCT04411030|Drug|Midazolam|Form: syrup; Route of administration: oral
15804829|NCT04411030|Drug|Itraconazole|Form: capsule; Route of administration: oral
15804830|NCT04411017|Procedure|Endoscopy|Colonoscopy
15804831|NCT04411004|Diagnostic Test|Transvaginal ultrasound|Transvaginal ultrasonographic scan to diagnosis the recurrence of rectal endometriosis
15804832|NCT04411004|Behavioral|5-point Likert scale|Subjective scale to evaluate satisfaction to previous surgical treatment for rectal endometriosis
15804833|NCT04410991|Drug|Tolebrutinib|"Pharmaceutical form: Tablet
~Route of administration: Oral"
15804834|NCT04410991|Drug|Teriflunomide HMR1726|"Pharmaceutical form: Tablet
~Route of administration: Oral"
15804835|NCT04410991|Drug|Placebo to match Tolebrutinib|"Pharmaceutical form: Tablet
~Route of administration: Oral"
15804836|NCT04410991|Drug|Placebo to match Teriflunomide|"Pharmaceutical form: Tablet
~Route of administration: Oral"
15804837|NCT04410978|Drug|Tolebrutinib|"Pharmaceutical form: Tablet
~Route of administration: Oral"
15804838|NCT04410978|Drug|Teriflunomide HMR1726|"Pharmaceutical form: Tablet
~Route of administration: Oral"
15804839|NCT04410978|Drug|Placebo to match Tolebrutinib|"Pharmaceutical form: Tablet
~Route of administration: Oral"
15804840|NCT04410978|Drug|Placebo to match Teriflunomide|"Pharmaceutical form: Tablet
~Route of administration: Oral"
15804841|NCT04410965|Drug|TERIFLUNOMIDE|Pharmaceutical form:tablet Route of administration: oral
15804842|NCT04410939|Diagnostic Test|Reverse transcription polymerase chain reaction|PCR test is performed from the oropharyngeal and nasal swab samples taken before admission to each pregnant to prevent contamination from the pregnant women hospitalized in this clinic. In addition, the same test is done before each operation and before the operation. The aim of the study is to scan these tests retrospectively and to determine the rate of positive COVID-19 cases in asymptomatic pregnant women. The results will determine the importance of the measures to be taken in the pregnant and undergoing pregnant women.
15804843|NCT04410926|Other|Corrective exercises|The experimental and control groups performed a designed strengthening exercises included short-foot exercise, toes-spread-out exercise, toes-extension exercise and toe-curls for 60 minutes
15804844|NCT04410926|Other|Neuromuscular electrical stimulation|The experimental group received NMES aiming to reinforce the planter intrinsic foot muscles for 30 minutes. The surface electrodes were placed over the abductor halluces. The control group received placebo NMES with no current stimulation.
15804845|NCT04410913|Drug|Psilocybin plus Visual Healing Set and Setting|Psychedelic session (psilocybin 25 mg) with a therapist who will guide and accompany participants before, during, and after the psychedelic session. In addition, participants will have the chance to view nature-themed videos before and after the psychedelic sessions. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).
15804921|NCT04410315|Other|Serum-lactate >/= 2,2 mmol/L|Bloodgas analysis every hour from start surgery until recovery ward discharge
15804846|NCT04410913|Drug|Psilocybin plus Standard Set and Setting|Psychedelic session (psilocybin 25 mg) with a therapist will guide and accompany participants before, during, and after the psychedelic session. Four weeks later, a second psychedelic session (psilocybin 25 mg) with either Visual Healing or standard Set and Setting procedures (patient's choice).
15804849|NCT04410887|Drug|PIPAC+SOX+OLAPARIB|SOX Chemotherapy regimen A cycle consists of Day 1: Oxaliplatin 130mg/M2 intravenous Day 1-14 Tegafur gimeracil oteracil potassium capsule 80mg/M2 oral (twice daily) Repeated every 21st day OLAPARIB Day 1-14: Olaparib 300mg BID PO
15804850|NCT04410874|Biological|Imvamune|Imvamune vaccine to be administered (via injection) intratumorally at one of three doses (1x10^7, 1x10^8, or 4x10^8 PFU) twice, 4 days apart (first injection on Day 0 of the study and second injection on Day 4)
15804851|NCT04410861|Procedure|Micropulse laser photostimulation|In this treatment invisible, non-damaging laser shots are delivered to the affected area which are believed to lead to absorption of accumulated retinal fluid. Contact lens will be used along with topical anesthesia.Following the procedure eye will be washed with balanced salt solution.
15804852|NCT04410848|Other|To determine the diagnostic of Choledocholithiasis with symbolic regression model|To determine the diagnostic of Choledocholithiasis with symbolic regression model
15804853|NCT04410835|Diagnostic Test|Online Survey|Psychological questionnaires
15804854|NCT04410822|Other|Clinical tests|Semi-qualitative interviews and questionnaire FITAS
15804855|NCT04410809|Biological|TA-46|Decoy protein of the fibroblast growth factor receptor 3, 50 mg/mL (Parts A, B and C) and 120 mg/mL (Part C and Part D), sc solution for injection/infusion
15804856|NCT04410809|Other|Placebo|The same composition as the active medication but without the active substance TA-46
15804860|NCT04410783|Behavioral|Education|Nurses and physicians will be engaged regarding the clinical outcome data on the importance of ED-based sedation, and the objectives of the research. Education will include in-services and lectures focused on the importance of sedation protocols on patient outcome. The use of sedation will be evaluated throughout the study in order to better understand providers' perception of and experience with ED-based sedation protocols.
15804861|NCT04410783|Other|Standard post intubation sedation practices|Usual care sedation provide in the ED
15804862|NCT04410770|Behavioral|Mood tracker ratings|The participant rates his/her emotional distress several times a week using a specially developed smart phone app. The participant receives support call to ensure that self-ratings are being completed.
15804863|NCT04410744|Diagnostic Test|Ultrasonographic examination|All clinical examinations (physical exam) and ultrasounds are performed by a single surgeon and a single radiology resident supervised by the same abdominal radiology consultant, respectively.
15804864|NCT04410731|Drug|Single bilateral intra-articular injection of allogeneic BM-MSCs for lumbar facet joint arthropathy|Single bilateral intra-articular injection of manufactured cell cultured expanded allogeneic BM-MSCs for painful lumbar facet joint arthropathy
15804865|NCT04410718|Other|Glycaemic levels|Glycaemic levels during admission for COVID-19
15804866|NCT04410705|Other|Extracorporeal shockwave theraphy for hamstring tendinopathy|For hamstring tendinopathy; a total of 2000 impulses will be done. We will apply twice a week and 5 times in total.
15804867|NCT04410705|Other|Extracorporeal shockwave theraphy for quadriceps tendinopathy|Energy flux density will be 0.58mJ/mm2 (2 bar) with 2000 impulses. We will perform twice a week, 5 times in total.
15804868|NCT04410705|Other|Extracorporeal shockwave theraphy for achilles tendinopathy|Each session consisted of 2400 impulses will be administered with an energy flux density ranged from 0.17 to 0.25 mJ/mm2 (1.7-2.5 bar). We will perform once a week, 3 times in total.
15804869|NCT04410692|Other|Prediction Market|"Participants bet on likely future outcomes using a prediction market"
15804870|NCT04410679|Biological|injectable PRF|blood sample and centrifuged to obtain i-PRF
15804871|NCT04410666|Other|Green Tea mouthwash|"an infusion at 13%, with 13 g of green tea (commercially divided) in 100 ml of saline solution, at a temperature of approximately 90 ° C, in sterile glass containers.
~Each application was 10 ml. applied for 1 minute."
15804872|NCT04410666|Other|Placebo Mouthwash|distilled water
15804873|NCT04410653|Drug|Afatinib 40 MG|single oral dose of afatinib each day starting at a dose of 40 mg on day 1, continuously, until the development of progressive disease or unacceptable adverse events
15804874|NCT04410640|Other|survey|Members chosen for this study group are general surgery residents. A quintet with stations composed of normal pancreaticobiliary anatomy, common bile duct tumor, stony cholecystitis, pancreatic head cancer and cholelithiasis was assembled for the study. Each station contained CT, 3D-STL images and 1:1 solid models of cases. Each imaging method associated with the scenarios of the quintet is observed by the residents of the study. An explanatory assessment measure is being used as data collection method where the perception of each imaging method is being evaluated based on their effectiveness in problem identification as well as their efficiency in diverse diagnosis and pre-surgery organization. Participants' perception of residency training was evaluated with a multi-entry survey. The focus of the survey, which was applied by our team was by domains, self determined decision-making, diverse diagnosis, academic scholarship, and scientific appraisal.
15804875|NCT04410627|Other|HoPE Website|Educational website focused on hospice care
15804876|NCT04410614|Procedure|Free epithelial (gingival) graft|1mm thickness epithelial layer harvested from the palate (1st molar area) is grafted and stabilised at the dental or implant area deficient of keratinized mucosa
15804877|NCT04410601|Procedure|Total thyroidectomy|DRT-diet modification, compensation strategies, oral motor exercises such as laryngeal elevation, masseters / tongue hold / exercise, bolus transition exercise; chin-down/up, head rotation, and other maneuvers with tactile stimulation.
15804878|NCT04410588|Drug|Fentanyl + Topical Levobupivacaine|in nasal packing
15804879|NCT04410588|Drug|levobupivacaine|in nasal packing
15804922|NCT04410302|Procedure|Biospecimen Collection|Undergo collection of tumor tissue, blood, saliva, and urine samples
15804880|NCT04410575|Other|Patient Assessment|Recording participant scores from the combined PHQ-9/GAD-7/BC-CCI/SDS questionnaire tool completed by the participant & uf determined clinically relevant by the pharmacist partner: appearance, current mood, sleeping patterns, mental health, medical history, social history, family history, relationships with others, suicidal ideation, previous suicide attempts or hospitalizations, current employment status
15804881|NCT04410575|Other|Collaboration and discussion with the patient's physician|Pharmacist partner initiates discussion with physician re: treatment plan (as per CANMAT guidelines) for MDD and GAD, which may include referral to psychotherapy resources (i.e. psychologist).
15804882|NCT04410575|Other|Prescription dose adjustment and/or prescribing adjunctive therapy|Prescribing action by pharmacist partner to achieve clinical response and/or remission of MDD and/or GAD and establish appropriate cognitive/functional status as per CAMAT guidelines
15804883|NCT04410575|Other|Communication update with physician after participant contact|Pharmacist partner provides communication update with the patient's family physician after each contact with the patient
15804884|NCT04410575|Other|Medication Counselling and Educational Support|Pharmacist partner provides medication counselling and educational support in person during initial interview and follow up with patient
15804885|NCT04410575|Other|Interim telephone follow-up|Interim telephone follow-up conducted by the pharmacist partner since the last in-person follow-up & a minimum of 1-2 weeks after the last in-person follow-up that involved a dose adjustment, prescribing of adjunctive medication, or discontinuation of therapy. (Note: a telephone follow-up does not replace the scheduled in-person follow-up).
15804886|NCT04410575|Other|Psychotherapy referral|Pharmacist partner collaborates with physician to arrange referral to psychologist/psychiatrist for psychotherapy
15804887|NCT04410575|Other|Standard Pharmacist Care|Standard pharmacy care (as outlined in the Alberta College of Pharmacist Standards of Practice for Pharmacist and Pharmacy technicians)
15804888|NCT04410562|Drug|Hydroxychloroquine|Participants will receive a bottle containing 19 tablets of study medication. They will be instructed to take two tablets for the first three days and one tablet for the following 11 days. (400 mg/day for three days, followed by 200 mg/day for 11 days).
15804889|NCT04410562|Drug|Placebo|Participants will receive a bottle containing 19 tablets of placebo. They will be instructed to take two tablets for the first three days and one tablet for the following 11 days.
15804891|NCT04410536|Drug|Symptomatic drugs|indomethacin suppository 50-100 mg or an oral triptan, on maximum 3 days/10 days, only in case of very severe headache- and to use metoclopramide
15804892|NCT04410536|Drug|Bridge therapy|prednisone 25 mg , 2 tablets after breakfast for 5 days, one tablet for 3 days, half tablet for 2 days ; bromazepam 1.5 mg, 1 tablet after breakfast, lunch and dinner for every day; pantoprazole 40 mg, 1 tablet after dinner every day
15804893|NCT04410536|Behavioral|Mindfulness program|home based withdrawal program
15804896|NCT04410510|Drug|P2Et (Caesalpinia spinosa extract)|P2Et active extract capsule equivalent to 250mg of P2Et every 12 hours for 14 days + Standard Care
15804897|NCT04410510|Other|Placebo|Placebo capsule equivalent to 250mg of excipients of P2Et every 12 hours for 14 days + Standard Care
15804898|NCT04410497|Other|Porcine xenograft (wound dressings)|commercial porcine xenograft, derived from acellular dermis from porcine.
15804899|NCT04410497|Other|Silver foam (wound dressings)|commercial silver containing foam dressing
15804900|NCT04410471|Diagnostic Test|CLIA of IgG and IgM against SARS-Cov-2|Report of clinical data
15804901|NCT04410458|Behavioral|blood donation SMS|The literature shows that the information extraction and processing in emergency is different from the normal situation. To find the most effective emergency recruitment method during an outbreak, we intervened with a well-balanced group of donors by presenting different emergency recruitment text messages.
15804904|NCT04410432|Biological|Blood sample collection|"Additional blood volumes taken during a routine care blood test:
~1 dry tube 5 mL for isolation and freezing of serum
~1 x 5 mL EDTA tube to isolate and freeze plasma
~8 heparinized 6 mL tubes for flow cytometry study"
15804905|NCT04410419|Dietary Supplement|Pre-operative carbohydrate drink|Carbohydrate drink containing 40g of carbohydrate to be consumed three hours prior to surgery
15804906|NCT04410406|Drug|Ivermectin|Ivermectin (IVM) 200 µg/kg
15804907|NCT04410406|Drug|Diethylcarbamazine|Diethylcarbamazine (DEC) 6mg/kg
15804908|NCT04410406|Drug|Albendazole|Albendazole (ABZ) 400 mg
15804909|NCT04410406|Drug|Moxidectin|Moxidectin (Mox) 8 mg
15804910|NCT04410393|Procedure|vaginal cuff prolapse surgery|Different surgical methods for the treatment of vaginal cuff prolapse in patients who have previously undergone hysterectomy for benign causes
15804911|NCT04410380|Behavioral|Electronic tablet provision with teaching|Spanish-speaking parents are provided with an electronic tablet and taught how to use it to access health information for their children.
15804912|NCT04410367|Drug|18F fluciclovine|18F fluciclovine injection, 185 MBq (5 mCi) ± 20%, delivered as an intravenous bolus
15804913|NCT04410354|Drug|Merimepodib|400 mg (total daily dose of 1200 mg) for 10 days
15804914|NCT04410354|Drug|Matching Placebo|0 mg (total daily dose of 0 mg) for 10 days
15804915|NCT04410354|Drug|Remdesivir|200 mg loading dose on Day 0 followed by 100 mg daily dose for 4 days. If a subject does not demonstrate clinical improvement, 100 mg daily dose may be extended for up to 5 additional days (for a total of up to 10 days)
15804916|NCT04410341|Drug|Vildagliptin 50 MG|Vildagliptin, an antidiabetic drug that inhibits the dipeptidyl peptidase- 4 (DPP-4), increases glucagon-like peptide-1 (GLP-1) and regulates blood glucose levels, favoring weight loss and lowering cardiovascular risk.
15804917|NCT04410341|Drug|Escitalopram 20 mg|Escitalopram,Selective serotonin reuptake inhibitor- Cilostazol, a selective phosphodiesterase 3 (PDE3) inhibitor, acts as an antiplatelet agent and has been widely approved for treatment of intermittent claudication with peripheral arterial disease and for secondary prevention of ischemic stroke.
15804923|NCT04410289|Procedure|Airway positioning per specified protocol followed by Direct Laryngoscopy and Endotracheal Intubation|Positioning of the patient's head and neck for the purpose of direct laryngoscopy and endotracheal intubation
15804924|NCT04410289|Procedure|Airway positioning per provider preference followed by Direct Laryngoscopy and Endotracheal Intubation|Positioning of the patient's head and neck for the purpose of direct laryngoscopy and endotracheal intubation
15804925|NCT04410263|Diagnostic Test|Sampling (EDTA blood, pharyngeal and nose swabs, bronchoalveolar lavage ,urine)|"Most data and part of the biological material required for addressing the research questions in this project are generated in the treatment of the patients. The following data and samples are collected specifically for this project according to the study schedule (i.e. extra sampling or additional questioning):
~blood samples (day 0= 40 ml EDTA, day 2= 20 ml EDTA, day 3= 30 ml EDTA, day 5=10 ml EDTA, every 5 days = 20 ml EDTA)
~Swabs (oral +/- nasal +/- nasopharyngeal)
~Sublingual microscopy"
15804926|NCT04410250|Behavioral|oral hygiene|Mothers will be instructed on the oral hygiene of the newborn
15804927|NCT04410237|Device|Med-Jet|"One half of each psoriasis plaque will be treated with a Med-Jet device and Triamcinolone acetonide (TAC) while the control half will be untreated.
~One side of the body will be treated using a conventional syringe and the opposite side of the body will be treated using the Med-Jet needle-free injection device to verify efficacy, safety, and pain score"
15804928|NCT04410237|Other|Traditional Syringe|"One half of each psoriasis plaque will be treated with a traditional syringe and Triamcinolone acetonide (TAC) while the control half will be untreated.
~One side of the body will be treated using conventional syringe and the opposite side of the body will be treated using the Med-Jet needle-free injection device to verify efficacy, safety, and pain score"
15804929|NCT04410224|Drug|ASN004|ASN004 is an antibody-drug conjugate for the treatment of advanced or metastatic solid tumors.
15804930|NCT04410211|Drug|Sevoflurane|"Incidence of side effects such as excitation, headache, apnea, airway obstructions are recorded. Patients who experiences severe excitation disinhibition as defined in the investigator's opinion as agitation. Uncontrollable patient movements that causes unsafe procedural conditions and conversion to general anaesthesia is needed
~Post procedural recovery scoring are taken which includes:
~Time taken from the point that the procedure ended to the first OAAS score of 5
~Time taken from (a) to meeting discharge eligilibility
~Pre and post procedure pyschometric test (delayed and immediate memory test, posting box test and Stroop test) will be done and compared by the blinded observer/investigator"
15804931|NCT04410211|Drug|Midazolam injection|"Incidence of side effects such as excitation, headache, apnea, airway obstructions are recorded. Patients who experiences severe excitation disinhibition as defined in the investigator's opinion as agitation. Uncontrollable patient movements that causes unsafe procedural conditions and conversion to general anaesthesia is needed
~Post procedural recovery scoring are taken which includes:
~Time taken from the point that the procedure ended to the first OAAS score of 5
~Time taken from (a) to meeting discharge eligilibility
~Pre and post procedure pyschometric test (delayed and immediate memory test, posting box test and Stroop test) will be done and compared by the blinded observer/investigator."
15804932|NCT04410198|Drug|Roxadustat|This open-label single arm study is designed to evaluate roxadustat dosing in maintaining hemoglobin in ESRD subjects receiving chronic dialysis treatments
15804933|NCT04410185|Behavioral|Meditation|Meditation sessions will take place over 12 weekly sessions of 1.5 hours
15804934|NCT04410172|Diagnostic Test|Mirror and prope|Mirror and probe will be used for each patient. Mirrors for proper visualization especially for maxillary teeth, explorers will be used to aid in tactile sensation.
15804935|NCT04410159|Drug|Povidone-Iodine|Gargle
15804936|NCT04410159|Drug|Essential oils|Gargle
15804937|NCT04410159|Other|Tap water|Gargle
15804938|NCT04410146|Device|SQUID|Embolization of the Middle Meningeal Artery using the SQUID non-adhesive liquid embolic agent
15804939|NCT04410146|Procedure|Burr-hole|Surgical evacuation of the sub-dural hematoma
15804940|NCT04410146|Other|Medical Management|Standard medical management: drug treatment and/or observation
15804941|NCT04410133|Drug|18F fluciclovine|18F fluciclovine injection, 185 MBq (5 mCi) ± 20%, delivered as an intravenous bolus
15804942|NCT04410120|Other|Interview|Semi-structured 45 minute interviews regarding impact of asthma attacks
15804943|NCT04410107|Diagnostic Test|Lung Function tests|Spirometry before and after bronchodilator, lung volumes by body plethysmography, lung diffusion capacity of carbon monoxide (DLCO), respiratory system resistance by impulse oscillometry (IOS)
15804944|NCT04410107|Diagnostic Test|Exercise capacity|6-minute walk test (6MWT distance)
15804945|NCT04410107|Diagnostic Test|Exercise physiology|Cardiopulmonary exercise test (CPET)
15804946|NCT04410107|Diagnostic Test|Health-related quality of life|Short-Form Health Survey Questionnaire (SF-36)
15804947|NCT04410107|Diagnostic Test|Respiratory symptoms, symptoms of anxiety and depression, and post-traumatic stress screening|"Adapted translation American Thoracic Society respiratory symptoms questionnaire;
~Beck Anxiety Inventory (BAI) and Beck's depression Inventory (BDI);
~Questionnaire for screening for post-traumatic stress symptoms (PTSD)."
15804948|NCT04410094|Drug|Lazertinib|Lazertinib tablets will be administered orally.
15804949|NCT04410094|Drug|Itraconazole|Itraconazole capsules will be administered orally.
15804950|NCT04410094|Drug|Rifampin|Rifampin capsules will be administered orally.
15804951|NCT04410081|Drug|14C-lazertinib|A single oral dose of 14C-lazertinib will be administered.
15804952|NCT04410068|Device|WARMTAC|Randomization to one of the arms previous to surgery.
15804953|NCT04410068|Device|3M Bair Hugger|Randomization to one of the arms previous to surgery.
15804954|NCT04410055|Behavioral|Sitting|We proposed a dynamic standing approach (working while standing accompanied by small periodic stepping movements) as a more tolerable and thereby more applicative lifestyle modification. To evaluate this form on healthy subjects, three different conditions were applied: 3 hours of sitting, static standing and dynamic standing. Both standing conditions were done with height-adjustable table which was developed at the University of Michigan (Ann Arbor, Michigan, USA)
15804990|NCT04409834|Drug|Unfractionated heparin SC|Unfractionated heparin 5,000 IU SC TID
15804991|NCT04409834|Drug|Enoxaparin 40 Mg/0.4 mL Injectable Solution|Enoxaparin 40 mg SC QD
15804955|NCT04410055|Behavioral|Static standing|We proposed a dynamic standing approach (working while standing accompanied by small periodic stepping movements) as a more tolerable and thereby more applicative lifestyle modification. To evaluate this form on healthy subjects, three different conditions were applied: 3 hours of sitting, static standing and dynamic standing. Both standing conditions were done with height-adjustable table which was developed at the University of Michigan (Ann Arbor, Michigan, USA)
15804956|NCT04410055|Behavioral|Dynamic standing|We proposed a dynamic standing approach (working while standing accompanied by small periodic stepping movements) as a more tolerable and thereby more applicative lifestyle modification. To evaluate this form on healthy subjects, three different conditions were applied: 3 hours of sitting, static standing and dynamic standing. Both standing conditions were done with height-adjustable table which was developed at the University of Michigan (Ann Arbor, Michigan, USA)
15804957|NCT04410042|Drug|Tranexamic Acid|Given IV
15804958|NCT04410042|Other|0.9% sodium chloride|Given IV
15804959|NCT04410029|Other|Healthwise Decision Aid|Healthwise, a non-profit company that develops health content and patient information for hospitals, has created a decision aid for EPL management that is available through the EPIC Systems, an electronic medical record. Participants will be given this decision aid after EPL diagnosis and prior to options consultation with a provider.
15804960|NCT04410029|Other|Control informational handout|Participants randomized to the control arm will be given an informational handout of treatment options after EPL diagnosis and prior to options consultation with a provider.
15804961|NCT04410016|Other|Staff Wellbeing Centres|2 Centres (rooms) accessible to staff for rest and relaxation, work breaks, supports advice and signposting. They are manned by support workers called Wellbeing Buddies.
15804962|NCT04410003|Biological|Fecal microbial transplant|Fecal microbial transplant
15804963|NCT04409990|Diagnostic Test|Shear Wave Elastography|SWE value of rectal lesions
15804964|NCT04409977|Diagnostic Test|MRI examination|Patient will be scanned in the MRI twice, once at noon (+/- 1 hour), once at 1 a.m. (+/- 1 hour). The investigators will search for any changes in functional connectivity, particular regarding the connection between the hypothalamus and pain-processing networks.
15804965|NCT04409964|Drug|Dexmedetomidine Hydrochloride|dexmedetomidine iv bolus followed by the infusion of 0.1-1 ug/kg/hr during general anesthesia
15804966|NCT04409964|Drug|Lidocaine Hydrochloride|lidocaine iv bolus followed by the infusion of 1.5 mg/kg/hr during general anesthesia
15804967|NCT04409964|Drug|Remifentanil Hydrochloride|remifentanil iv infusion of 0.5-5 ng/ml (effect site concentration using TCI) during general anesthesia
15804968|NCT04409938|Other|Progressive Muscle Relaxation|PMR participants rested for ten minutes between the sessions and then practiced PMR for 15 minutes. PMR consisted of taking a deep breath five times and then clenching fists, raising the shoulders, bringing the forearms towards the body, stretching the triceps muscle, and tensing and relaxing the forehead, eye, chin, neck, chest, abdomen, back, hips, thigh, and feet muscles. The investigators made a video of exercises in a certain order and uploaded it to the television in the lab prior to the intervention. The investigators turned on the video during the intervention and asked the participants to follow the instructions for PMR exercises.
15804969|NCT04409938|Other|Nature Sounds|PMR+NS participants practiced PMR accompanied by nature sounds. PMR consisted of taking a deep breath five times and then clenching fists, raising the shoulders, bringing the forearms towards the body, stretching the triceps muscle, and tensing and relaxing the forehead, eye, chin, neck, chest, abdomen, back, hips, thigh, and feet muscles. The investigators made a video of exercises in a certain order and uploaded it to the television in the lab prior to the intervention. The investigators turned on the video during the intervention and asked the participants to follow the instructions for PMR exercises.
15804970|NCT04409925|Drug|rhDNase I|Inhaled nebulisations
15804971|NCT04409912|Device|Sirolimus coated balloon|"Sirolimus has a high transfer rate to the vessel wall and effectively inhibit neointimal hyperplasia in the porcine coronary model. In coronary artery interventions, preliminary clinical studies using sirolimus coated balloon have shown excellent procedural and 6 month patency. The effectiveness of sirolimus coated balloon in patients with dialysis access dysfunction has been shown in a small pilot study in the salvage of thrombosed arteriovenous graft.
~When compared to Paclitaxel, sirolimus is cytostatic in its mode of action with a high margin of safety."
15804972|NCT04409912|Device|Plain balloon|Plain balloon angioplasty is the current standard therapy to treat stenosis in dialysis access. However, the mid and long term patency of plain balloon angioplasty in patients with end stage renal disease is poor. The average primary patency is around 40 to 50 percent at 1 year and multiple repeated angioplasty is required to maintain the patency of the vascular access.
15804973|NCT04409899|Diagnostic Test|Blood tests|RT-PCR, D-dimer, CRP, procalcitonin, ferritin, complete haemogram
15804974|NCT04409886|Biological|Hyperbaric Oxygen Therapy|Hyperbaric Oxygen Therapy in Non-ventilated COVID-19 Patients (HBOT)
15804975|NCT04409873|Drug|Oral-B Mouth Sore mouthwash|Rinse and gargle 4 times daily, for 60 seconds, for 4 weeks.
15804976|NCT04409873|Drug|Crest Pro-Health Multi-Protection mouthwash|Rinse and gargle 4 times daily, for 60 seconds, for 4 weeks.
15804977|NCT04409873|Drug|CloSYS Ultra Sensitive Rinse mouthwash|Rinse and gargle 4 times daily, for 45 seconds, for 4 weeks.
15804978|NCT04409873|Drug|Distilled water|Rinse and gargle 4 times daily, for 60 seconds, for 4 weeks.
15804979|NCT04409873|Drug|Listerine Zero Mouthwash Product|Rinse and gargle 4 times daily, for 30 seconds, for 4 weeks.
15804980|NCT04409860|Radiation|CCRT|Radiation concurrent paclitaxel and cisplatin once a week
15804981|NCT04409860|Drug|Paclitaxel, Cisplatin|The regimen of adjuvant chemotherapy following CCRT is Paclitaxel(150mg/m2 D1), Cisplatin(60mg/m2 D1) , q3w, three cycles.
15804982|NCT04409847|Diagnostic Test|ABPM|24 hour ambulatory blood pressure monitoring
15804983|NCT04409847|Diagnostic Test|ECG|Electrocardiogram
15804984|NCT04409847|Diagnostic Test|FMD|Flow mediated dilatation
15804985|NCT04409847|Diagnostic Test|PWV|Pulse wave velocity
15804986|NCT04409847|Diagnostic Test|Rarefaction|nailbed capillaroscopy
15804987|NCT04409834|Drug|Unfractionated Heparin IV|Unfractionated heparin IV targeting an aPTT of 1.5-2.5 times the control
15804988|NCT04409834|Drug|Enoxaparin 1 mg/kg|Enoxaparin 1 mg/kg SC Q12h
15804989|NCT04409834|Drug|Clopidogrel|Clopidogrel 300 mg PO x1, then clopidogrel 75 mg PO QD
15805104|NCT04408755|Drug|AVP-786|oral capsules
15804992|NCT04409821|Behavioral|Tele-delivered psychological intervention|The intervention consists of two (or one, if preferred by caregivers) weekly tele-sessions during the ICU stay, lasting up to 30 minutes, and two sessions in the month after discharge from or death in the ICU. Sessions will be conducted via phone-calls or video-conferencing. Therapists will 1) validate caregivers' subjective experience, 2) normalize and psychoeducate about emotional reactions, and 3) offer emotion regulation drawing on contemporary cognitive treatment packages of decentering, acceptance and emotion tolerance. Sessions for bereaved caregivers will include psycho-education about grief, assessment of risk for adverse outcomes and information about available support, if needed. The intervention will be performed based on an intervention manual. The content of the intervention will be continually adapted and tailored to the needs of the participating caregivers by involving all caregivers in co-creating the intervention trough brief post-session interviews.
15804993|NCT04409808|Device|IRIS|prototype IRIS vitrectomy device.
15804994|NCT04409795|Drug|Metformin Extended Release Oral Tablet|Initial oral hypoglycemic agent added to existing insulin treatment
15804995|NCT04409795|Drug|Sitagliptin|Secondary oral hypoglycemic agent added to existing insulin treatment (for those who are intolerant to or unable to achieve glycemic targets with metformin)
15804996|NCT04409782|Other|Group education|Participants will receive education covering the key messages pertaining to cancer research studies and clinical trials, in a group class setting. Education will be facilitated with one or more of the following educational tools: PowerPoint presentation, written materials/handouts, and displays. Data will be collected via pre- and post-tests. The post-test includes questions to pre-screen participants for eligibility into cancer research studies and clinical trials; as appropriate, study participants will be referred to those study/trial/clinical teams for follow-up.
15804997|NCT04409782|Other|Online educational video and website module|Participants will receive online education via a video and written web content. Key messages will include information pertaining to cancer research studies and clinical trials. Data will be collected via pre- and post-tests. The post-test includes questions to pre-screen participants for eligibility into cancer research studies and clinical trials; as appropriate, study participants will be referred to those study/trial/clinical teams for follow-up.
15804998|NCT04409769|Other|Description of use of ceftaroline and ceftobiprole|Ceftaroline and ceftobiprole are the only betalactam active on methicillin-resistant staphylococci. Description of condition of use of thoses antibiotics in PJI and BJI
15804999|NCT04409756|Other|shoulder rating questionnaire|to investigate reliability of turkish version of shoulder rating questionnaire
15805000|NCT04409743|Behavioral|Remote Cognitive Behavioral Therapy for Insomnia|Participants will meet with a psychologist through telehealth once a week for four weeks to complete a brief CBT-I intervention. Cognitive Behavioral Therapy for Insomnia consists of a cognitive therapy and a behavioral therapy. The cognitive therapy is designed to identify incorrect ideas about sleep, challenge their validity, and replace them with correct information. This therapy tries to reduce worry, anxiety, and fear that one won't sleep by providing accurate information about sleep. The behavioral therapy increases sleep quality by limiting excessive time spent in bed to increase homeostatic sleep drive and sleep consolidation.
15805001|NCT04409730|Other|Photographic Posture Analysis|Postural evaluation was done using the photographic method. All measurements were made by two researchers experienced in postural analysis evaluation. Canon camera and national geographic tripod with double spirit level were used for evaluation. The camera was placed on a 115 cm high tripod, 1.5 m away from the subjects. Spirit levels have been adjusted so that the tripod is completely flat on the ground. The tripod was taped to the floor to maintain the same distance between the camera and the participants. Six photographs of each child whose feet on the ground, in a free-sitting position, 3 from the front and 3 sides were taken by the researchers.
15805002|NCT04409717|Procedure|Type II endoleak treatment|Type II endoleak endovascular treatment
15805003|NCT04409704|Device|Repetitive Transcranial Magnetic Stimulation|10 Hz repetitive transcranial magnetic stimulation to dorsomedial prefrontal cortex, once daily, 5 days per week, 20-30 sessions.
15805004|NCT04409691|Drug|prednison and Sirolimus|If the intravenous prednisolone 4 mg / kg / d (one time in the morning and one time in the evening, 2mg / kg body weight each time) is effective, it will be gradually reduced to 2mg / kg / D (one time in the morning and one time in the evening, 1mg / kg body weight each time), gradually converted to oral prednisone of equal dose, and the hormone will be removed within 4-6 weeks. At the same time, the dosage of sirolimus oral liquid is 0.8 mg / m2 twice a day, with an interval of 12 hours, maintaining the blood concentration of 8-15 ng / ml. if there is no intolerable side effect, the treatment will last for 6 months
15805005|NCT04409691|Drug|prednison|Prednison is taken at a dose of 4mg/kg/d. If the hormone treatment is effective, it will be gradually reduced to 2mg / kg / d (one time in the morning and one time in the evening, 1 mg / kg body weight each time), and repeated after 2 months of continuous treatment and 1 month of drug withdrawal.
15805006|NCT04409678|Behavioral|activity|physical activity
15805007|NCT04409665|Drug|Ketamine|Patient will be sedated using Ketamine 2 minutes before the LISA procedure. 10 minutes prior the procedure and during the procedure the patient's pain and/or discomfort will be evaluated using COMFORT and FANS scales
15805008|NCT04409665|Drug|Glucose|Patient will be sedated using Glucose 2 minutes before the LISA procedure. 10 minutes prior the procedure and during the procedure the patient's pain and/or discomfort will be evaluated using COMFORT and FANS scales
15805012|NCT04409626|Other|Plasma sodium level (continuous variables)|Observational study, so the exposures of interest (5-year mean and minimum plasma sodium) are not administered to the patients. Ultimately, our interest is in hyponatraemia.
15805105|NCT04408755|Drug|Placebo|oral capsules
15805013|NCT04409613|Other|Education and counseling|All patients or their caregivers will receive twenty minutes educational sessions for the first three visits according to patient ability to understand. At subsequent visits along the study duration, we will briefly review our educational material to refresh the patient's information. This will include: The objectives of treatment, disease progression process, risk factors, common symptoms of bleeding/thrombotic events and how to deal with this. Lifestyle modifications, including smoking cessation, blood pressure and diabetes control. Drug information: drug action, dose, indication, possible side effects, how to deal with the side effects, actions to take when missing the dose, storage conditions and when and how to administer. Possible interactions including drug-drug and drug-food interactions. Target INR and INR monitoring
15805014|NCT04409600|Behavioral|Supervised Gait Retraining|The participants allocated to this group will attend 8 sessions during the course of 6 weeks in the clinic with a trained medical professional to complete a supervised gait retraining program.
15805015|NCT04409600|Behavioral|Home Based Gait Retraining|The participants allocated to this group will have 1 session in the clinic with a trained medical professional and be given a gait retraining program to complete at home.
15805016|NCT04409600|Drug|Saline Injection|The participant will receive a saline injection to their painful lower leg compartment(s).
15805017|NCT04409600|Drug|Botulinum Toxin Injection|The participant will receive a botulinum toxin injection to their painful lower leg compartment(s).
15805018|NCT04409587|Drug|Aspart|"A population of well controlled patients with type 1 diabetes who are experienced in the use of both Continuous Subcutaneous Insulin Infusion (CSII) and Continuous Glucose Monitor (CGM) was chosen in order to assess the effect of the change in glycemic profile using two different methods of basal insulin delivery. Allowing the subjects to use their insulin pumps for bolus insulin delivery, as they are accustomed, will minimize the chances of skipping meal boluses and correction doses.
~Replacing basal insulin delivery by CSII with a single daily injection of degludec will add minimal, if any, treatment burden which will be offset by potential therapeutic benefits. These benefits include the potential for reduced glycemic variability and the elimination of the risk of hyperglycemia and DKA with basal insulin interruption which can occur with infusion set occlusion or disgorging inherent to Continuous Subcutaneous Insulin Infusion."
15805019|NCT04409561|Device|Blood collection|9 mL K3-EDTA anticoagulated venous whole blood and 9 mL lithium heparin anticoagulated venous whole blood will be collected, processed in plasma and stored until the shipment to the sponsor for PSP measurement on the abioSCOPE device with IVD CAPSULE PSP kits
15805020|NCT04409548|Other|All of the spatial and Temporal Gait parameters|
15805021|NCT04409535|Other|WHOQOL-BREF survey|Participants will be surveyed and interviewed about their perceptions regarding COVID-19 health emergency
15805022|NCT04409522|Drug|Melatonin|Participants in this group, in addition to receiving the usual treatment of COVID-19, will receive a 9 mg dose of melatonin for seven to ten nights.
15805023|NCT04409522|Drug|The usual treatment|Participants in this group will receive the usual treatment of COVID-19
15805024|NCT04409509|Biological|Garadacimab, Factor XIIa Antagonist Monoclonal Antibody|Garadacimab, Factor XIIa Antagonist Monoclonal Antibody administered intravenously
15805025|NCT04409509|Drug|Placebo|CSL312 diluent administered intravenously
15805026|NCT04409496|Behavioral|Chat-based instant messaging support|"Subjects will receive personalised instant messaging support for 12 weeks after baseline, address the five problems that contributed to smoking relapse:
~(1) lack of support for cessation, (2) negative mood or depression, (3) strong or prolonged withdrawal symptoms, (4) weight gain, and (5) smoking lapses. Updated information about the negative effect of smoking on risk of COVID-19 infection and prognosis will also be delivered."
15805027|NCT04409496|Behavioral|SMS message support|Subjects will receive regular SMS on generic smoking cessation for 3 months.
15805028|NCT04409496|Behavioral|Self-help booklet|Subjects will receive a standard self-help booklet on smoking relapse prevention.
15805029|NCT04409483|Drug|Lopinavir-Ritonavir Drug Combination|400mg/100mg taken orally twice daily for 14 days.
15805030|NCT04409483|Combination Product|Standard Care|Paracetamol as needed for the symptomatic treatment of fever and vitamin C 1000 mg daily
15805031|NCT04409470|Diagnostic Test|Blood gas sampling from artery and vein|Patients included in this study are treated according to clinical routine. After inclusion, sampling of an arterial blood gas and a venous blood gas is performed simultaneously or as close in time as possible. Because the venous blood gas analysis sample can be taken directly from the patient's peripheral venous catheter, no additional venous puncture is usually required and the additional amount of blood that may be required is approx. 1 ml (the assay requires about 500 µl). In the very rare cases where it is not possible to establish a peripheral venous catheter within a reasonable time, the sample will be acquired from a new venous puncture together with other venous routine samples.
15805032|NCT04409457|Other|fasting state|16 hours of fasting
15805033|NCT04409457|Other|fed state|fed a standardized meal
15805034|NCT04409457|Other|magnetic resonance imaging|neuroimaging with computational modeling
15805035|NCT04409444|Diagnostic Test|Lung Cancer Screening|The lung health check consists of a symptom questionnaire for the calculation of 6-year lung cancer risk (using the PLCOM2012 model)
15805036|NCT04409444|Diagnostic Test|Biomarkers|This will explore the role of biomarkers for the early detection of lung cancer. These include circulating nucleic acids, circulating proteins, circulating tumour cells and inflammatory markers.
15805037|NCT04409431|Procedure|Endovascular chemical Ablation of Adrenal Gland|Patients in this group will be treated with partial ablation of adrenal gland by endovascular injection of dehydrated alcohol
15805038|NCT04409418|Device|Extended dwell catheters|EDCs are generally placed using ultrasound for guidance and are commonly placed in any of 3 veins in the arm. They can be inserted above or below the antecubital fossa (the bend of your elbow). These catheters can be left for up to 30 days and don't fail as quickly when compared to peripheral IVs.
15805039|NCT04409392|Other|Prothestic joint infection due to Staphylococcus lugdunensis|description of prosthetic joint infection with Staphylococcus lugdunensis
15805040|NCT04409379|Diagnostic Test|Relative telomere length|Relative telomere length in peripheral blood cell
15805123|NCT04408651|Behavioral|LIIT.CI CFT|4-week online self-management intervention based on Compassion-Focused Therapy and adapted to people with chronic medical conditions
15805041|NCT04409366|Other|Conventional Crown Lengthening (CCL)|Using the surgical guide, submarginal internal bevel incisions were performed on the buccal aspect of the affected teeth. A full-thickness flap was raised up to the mucogingival junction (Dominguez et al., 2020). Ostectomy and osteoplasty were carried out by means of rotatory instruments and surgical chisels, as necessary, to achieve the necessary space between the bone crest and the restorative margin according to the presurgical plan. The CEJ was not the reference point since, in many cases, the position of the final margin of the restoration was planned apical to the actual position of the CEJ. Exposed root surfaces were carefully instrumented manually with curettes and, finally, vertical internal mattress sutures were placed to position the gingival margin at the level of the margin of the planned restoration. Sutures were removed after 7 days
15805042|NCT04409366|Other|Two-stage Crown Lengthening (SCL)|In the first surgical intervention, intrasulcular incisions were performed and a full thickness flap was raised up to the mucogingival junction. Ostectomy and osteoplasty were performed to establish the space for supracrestal tissue attachment, following the restorative plan and using the presurgical blueprint as the reference to determine the final position of the restoration margin, instead of the CEJ (Lee, 2004). Then the flaps were repositioned and secured with internal mattress sutures, placing the gingival margin at the original level. Sutures were removed at 7 days. In the second stage, after 3-4 months, minor gingival recontouring was performed, if necessary, to attain the desired gingival margin position according to the presurgical plan.
15805043|NCT04409353|Device|PICO G2 4k|Participants will use the Pico G2 4K VR audio and visual head-mounted device. The Pico G2 4K is a standalone VR headset that comes with an orientation-tracked controller. It does not require a smartphone or personal computer to operate. The device supports 3 degrees of freedom (3DOF) head tracking, has best-in-class optics, and a wide field-of-view.
15805044|NCT04409340|Device|Magnetic Resonance Viscoelastography|Magnetic Resonance Viscoelastography
15805045|NCT04409340|Device|QUS|QUS
15805046|NCT04409327|Drug|RTB101|Oral RTB101 10 mg hard gelatin capsule once daily for 4 weeks
15805047|NCT04409327|Drug|Placebo|Oral matching placebo once daily for 4 weeks
15805048|NCT04409314|Drug|Fluorine F 18-fluoroazomycin Arabinoside|Given IV
15805049|NCT04409314|Procedure|Positron Emission Tomography|Undergo PET scan
15805050|NCT04409301|Other|My Special Aflac Duck (MSAD)|The hospital Child Life Specialist or research team member will introduce the child and parent to My Special Aflac Duck MSAD), with instructions on how to use the duck. MSAD is a robotic toy with an associated app. Children can use MSAD for play, exploring feelings, and describing medical procedures. Intervention hospitals are permitted to provide their standard of care from Child Life with the exception of providing stuffed animal-like objects. Data will be recorded by Child Life or research team member on what tools are used outside of the MSAD.
15805051|NCT04409301|Behavioral|Standard of care control|Sites will follow their individual standard of care from Child Life. Data will be recorded by Child Life on what tools are used. After completion of the 3-month survey, patients at hospitals assigned to not initially receive MSAD will each receive a MSAD.
15805052|NCT04409288|Drug|Apalutamide|Androgen receptor inhibitor.
15805053|NCT04409288|Drug|Enzalutamide|Androgern receptor inhibitor
15805054|NCT04409262|Drug|Remdesivir|Participants will receive intravenous (IV) RDV
15805055|NCT04409262|Drug|Tocilizumab|Participants will receive IV TCZ
15805056|NCT04409262|Drug|Placebo|Participants will receive IV placebo matched to TCZ
15805057|NCT04409249|Diagnostic Test|imaging, blood tests|PCR and CT results, hemogram, urea, creatinine, AST, ALT, LDH, D-Dimer, ferritin, lipase, amylase, CRP, procalcitonin, albumin, total protein, coagulation tests-PT, APTT, Fibrinogen-, Troponin T, CK , electrolytes, blood gas, bilirubins
15805061|NCT04409223|Drug|Famitinib capsules|Oral KIT/PDGFRA kinase inhibitor
15805062|NCT04409223|Drug|Sunitinib Capsules|Oral receptor tyrosine kinase (RTK) inhibitor
15805063|NCT04409210|Behavioral|Establishment of individual health records|Patients could upload self-test data (such as blood pressure, blood glucose, heart rate and weight) and medical institution examination data (such as blood lipids, ECG, echocardiography, etc.) through App. AND then the App can automatically generate health reports to reflect the dynamic changes of the data in the form of charts and whether the data is normal or not. It is convenient for patients to have a clear understanding of their health management, and if there are outliers, they can intervene in time.
15805064|NCT04409210|Behavioral|Cardiovascular risk assessment|The China-PAR risk prediction tool can be used to stratify the 10-years atherosclerotic cardiovascular disease (ASCVD) risk. Those with predicted risks of <5%, 5-10%, and ≥10% could be classified into categories of low-, moderate-, and high-risk for ASCVD, respectively. It is a risk prediction tool for Chinese developed by the team of Professor Gu Dongfeng of Fuwai Hospital of the Chinese Academy of Medical Sciences. When patients are aware of their risk of cardio-cerebrovascular diseases, it is helpful for patients to take the initiative to manage their cardio-cerebrovascular health.
15805065|NCT04409210|Behavioral|Popularization of medical knowledge|Health education is divided into nine modules, such as introduction of cardio-cerebrovascular diseases, diet, exercise, sleep, psychology, medicine, cardiopulmonary resuscitation and cardiac self-rescue technology. The presentation of health education includes three modules: text, video and voice. Video and voice modules are more suitable for illiterates or people are inconvenient to read text. It mainly takes into account the fact that most of the high-risk population of cardio-cerebrovascular diseases are the elderly.
15805066|NCT04409210|Behavioral|Personalized Reminders|"Abnormal data reminder App can automatically judge whether the data is normal. If abnormal data is found, it will inform the patient in red font and remind the patient to consult the doctor in time. Patients can consult their family doctors directly online through App or go to the hospital.
~Medication reminder After patients upload their own medication information, the App will automatically generate a medication alarm clock to remind patients to take the drugs.
~Follow-up reminder According to the clinical diagnosis and conditions of patients, make personalized follow-up time. Family physicians could use the App to remind patients to fill in the follow-up form or go to the hospital."
15805067|NCT04409210|Drug|Routine treatment|Family physicians conduct the corresponding treatment and management according to the diagnosis and conditions of the patients.
15805068|NCT04409171|Diagnostic Test|oral glucose tolerance test|
15805069|NCT04409145|Drug|VT30|VT30 gel is intended as a topical treatment of cutaneous VMs, LMs, or VLMs that driven by inappropriate PI3K activation. In the skin, VT30 is rapidly metabolized to VT10, an active drug form, and is intended to sufficiently permeate the stratum corneum and achieve target engagement. It is expected that VT30 will lead to amelioration of the signs and symptoms of cutaneous VMs, LMs and/or VLMs.
15805070|NCT04409132|Drug|Triferic|Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.
15805071|NCT04409119|Device|HIS/LBB pacing|3830 lead to HIS or LBB
15805072|NCT04409119|Device|LV pacing|LV lead in a CS branch
15805073|NCT04409093|Procedure|Nail bed repair with eponychial sent|The nail bed repair will be performed with 6-0 chromic suture material. After the nail bed repair, an eponychial stent will be secured under the eponychial fold with suture. The stent can be the native nail plate, suture container foil, or nonadherent gauze (i.e. Xeroform). If the injury avulsed the nail plate and the patient presents without it, either the foil from the suture wrapper/container or a piece of nonadherent gauze (i.e. Xeroform) will be used as a stent. A nonadherent sterile dressing will be applied to the digit, and each patient will be discharged with a 5-day course of cephalexin for prophylaxis against infection.
15805074|NCT04409093|Procedure|Nail bed repair without eponychial stent|The nail bed repair will be performed with 6-0 chromic suture material. After the nail bed repair, an eponychial stent will not be secured under the eponychial fold. A nonadherent sterile dressing will be applied to the digit, and each patient will be discharged with a 5-day course of cephalexin for prophylaxis against infection.
15805076|NCT04409067|Diagnostic Test|electromyography|Surface electromyography (sEMG) was used as an additional non-invasive tool for assessing patients with TMD.The electromyographical (EMG) potentials of the temporalis and masseter muscles were measured with a DAB-Bluetooth Instrument (Zebris Medical GmbH, Germany) at rest and during maximum voluntary clenching (MVC).
15805077|NCT04409054|Other|Cough and Valsalva effort|Three increasingly cough effort and three Valsalva type effort at four different volumes of rectal distension (empty rectum, volume for a first sensation of filling, volume for desire to defecate and maximal tolerable volume) while recording the external anal sphincter activity
15805078|NCT04409041|Drug|Low-Dose Naltrexone|Based on the promising evidence, we propose using low-dose naltrexone at a daily dose of 3mg to treat lichen planopilaris and frontal fibrosing alopecia. The patients would be continued on their other medications for these conditions. The study would be open-label, so all participants would receive the low-dose naltrexone. Patients would be seen at 0,3,6 and 9months to monitor their progress.
15805079|NCT04409028|Procedure|Coronal restoration|A restorative material like composite resin is condensed into the cavity of teeth.
15805080|NCT04409015|Device|ROTEM - rotation thromboelastometry testing|The ROTEM® is a simple blood test that provides information about specific components involved in blood clotting and stopping hemorrhage.
15805084|NCT04408989|Drug|MB02-SP|Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
15805085|NCT04408989|Drug|MB02-DM|Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
15805086|NCT04408989|Drug|US licenced Avastin®|Solution for intravenous infusion, single dose of 1mg/kg, administered as 90-minute infusion
15805088|NCT04408937|Drug|triopifexor|Tropifexor as a dry blend in hard gelatin capsules for oral administration
15805089|NCT04408937|Drug|Placebo|Placebo capsules for oral administration
15805091|NCT04408911|Drug|Midazolam vs. Lormetazepam|In this retrospective analysis we compared critically ill ICU patients receiving midazolam to those receiving lormetazepam.
15805092|NCT04408898|Genetic|ADP-A2M4 in combination with pembrolizumab.|Single infusion of autologous genetically modified ADP-A2M4 Dose: 1.0 x109 to 10x109 transduced cells by a single intravenous infusion Repeat doses of pembrolizumab every 3 weeks. Dose: 200mg
15805093|NCT04408885|Other|Rehabilitation|Non-surgical interventions to patients with an Anterior cruciate ligament injury. Rehabilitation regime is the regime provided by the physician at the rehabilitation clinic.
15805094|NCT04408872|Diagnostic Test|Esophago-gastro-duodenoscopy (EGD)|EGD: ENDOSCOPIC PROCEDURE DURING WHICH THE ESOPHAGUS, STOMACH AND DUODENUM ARE VISUALISED WITH A TINY CAMERA IMPLANTED AT THE END OF AN ENDOSCOPE.
15805095|NCT04408872|Diagnostic Test|Endoscopic ultrasound (EUS)|EUS: SAME AS EGD, BUT IN ADDITION HAS AN INTEGRATED ULTRASOUND PROBE WHICH ALLOWS TO EXAMINE THE PANCREAS, LIVER AND BILIARY SYSTEM.
15805096|NCT04408859|Drug|Neoadjuvant Chemotherapy|The patients receive neoadjuvant chemotherapy for 2-4 cycles before surgery.
15805097|NCT04408846|Device|Lumbar fusion|Patients will receive a single level instrumented fusion using a minimally invasive or open traditional surgical procedure with a posterior fixation. For the use of a posterior fixation system, the CD Horizon® Spinal System, is mandatory in this study and will be either minimally invasive or open.
15805098|NCT04408820|Drug|Roxadustat|Oral
15805099|NCT04408807|Other|Speculum-free (SpF) fundoscopy|Indirect ophthalmoscopy without the use of eyelid speculum and scleral indentation
15805100|NCT04408807|Other|Speculum (Sp) fundoscopy|Indirect ophthalmoscopy with the use of eyelid speculum and scleral indentation
15805101|NCT04408794|Drug|Vazegepant (BHV-3500)|10 mg intranasal (IN) up to 8 times per month, up to 1 year
15805102|NCT04408781|Procedure|Ridge expansion by osseodensifcation/Ridge expansion by ridge splitting|Ridge expansion by ridge splitting using the piezotome in conjunction with simultaneous implant placement in narrow ridges.
15805103|NCT04408768|Other|standard protocol for stroke patients|Standard protocol for stroke patients
15805106|NCT04408742|Other|pain|"Lower abdominal and low back pain was questioned. Pain intensity was evaluated with a 0 to 10 cm visual analog scale (VAS): 0 indicated no pain and 10 indicated the worst imaginable pain [18]. Pain that developed during the activity was also questioned and stated as pain+ activity. A higher score indicates a more severe pain."
15805107|NCT04408742|Other|fatigue|"Fatigue was assessed by the Fatigue Severity Scale (FSS). This is a 9-item questionnaire that assesses the effect of fatigue on daily living. Each item is a statement on fatigue that the subject rates from 1 completely disagree to 7 completely agree. A score of 4 or higher generally indicates severe fatigue."
15805108|NCT04408742|Other|anxiety|"The Spielberger State Trait Anxiety Inventory (STAI) was used to evaluate levels of anxiety. The state part of the STAI is a 20-item self-report inventory designed to measure state anxiety (current feelings of apprehension, worry, etc.). The STAI state scale is scored on four levels of anxiety intensity from 1 not at all to 4 very much and with a total score between 20 and 80. A higher total score indicates a more severe anxiety level."
15805109|NCT04408742|Other|position sense|Knee position sense was evaluated with a Acumar dual digital inclinometer. Each participant was asked to wear shorts and to lie down in supine position treatment table. The lower extremity of the participant was positioned in neutral for the knee flexion movement. The placement of the digital inclinometer's attachment was the lateral ridge of the femur and tibia. We actively assisted the participant's knee to the target angle and asked the participant to hold it there for 5 seconds before returning the knee to the starting position. After returning to the starting position, participants attempted to repeat the previously attained angle. Participants indicated verbally when they felt they had reached the angle and held their position. This procedure was repeated 3 times for each limb (non-dominant and dominant). We measured the absolute difference between the target angle and the observed angle and calculated the absolute error score by averaging the 3 trials.
15805110|NCT04408742|Other|balance|The Biodex Balance System (Biodex Medical Systems, Shirley, NY, USA) was used to measure limits of stability. The participants were asked to position themselves in a comfortable position on the platform and their foot position coordinate was recorded. The participants were asked to complete as quickly as possible the directional tasks displayed on a screen, with the directions displayed at random. A total of 3 tests were performed, at intervals of 10 s. A total score was recorded. The higher the total score, the better the ability of the subjects to transfer the center of gravity.
15805111|NCT04408742|Other|dual task performance|"The timed up and go test (TUG) was used in the evaluation of dual task performance. For this test, participants were seated on a standard armless chair and a cone was placed 3 meters away from the chair. Participants were instructed to stand up and (1) walk towards the cone, (2) turn around the cone, (3) walk back to the chair, and (4) sit back on the chair. It was stated that patients should walk without running but as fast as possible. TUG test was performed initially without task, and then with cognitive and motor tasks, respectively. Cognitive task given during the test is counting three backwards from 100 or counting the names starting with the letter A, and motor task given is to carry three glasses of water on a tray. The time elapses between standing up from the chair and sitting back to chair was recorded as the test result. As time increases, dual task performance decreases."
15805112|NCT04408729|Other|PrEP My Way|"Intervention components may be modified pending the input from Aim 1. As currently planned, the peer delivering the PrEP My Way kit will be trained to provide basic education and support use of the kit components. The peer will also have a smart phone to show an instructional video. Participants will communicate with peers via mobile phones (e.g., SMS, WhatsApp) to arrange for kit delivery at Months 1, 3, and 6 via unmarked vehicles at home or a preferred safe site during reasonable hours. Two-way mobile phone communication will also be used to convey test results and provide on-going support and empowerment. Follow-up with the clinic will occur at Month 6 and as needed (e.g., treatment for positive tests).
~This intervention aims to increase adherence/persistence on PrEP. We hypothesize that removing the structural barriers and stigma associated with going to the clinic, women may be more likely to continue on PrEP."
15805113|NCT04408716|Procedure|Ablation Index Guided High-Power Short-Duration Strategy|Point-by-point circumferential pulmonary vein ablation will be performed using the advanced STSF catheter under ablation index guided high power short duration strategy (Radiofrequency energy is set up at a power of 50 W, temperature of 43 °C, contact force of 5-20 gram, and flow rate of 20 mL/min; Target ablation index is set to 500 at the anterior wall and 350 at the posterior wall of left atrium).
15805114|NCT04408716|Procedure|Standard Radiofrequency Ablation Technique|Point-by-point circumferential pulmonary vein ablation will be performed using the ST catheter under standard radiofrequency ablation settings (Radiofrequency energy is set up at a power of 30 to 35 W, temperature of 43 °C, contact force of 5-20 gram, and flow rate of 17 to 30 mL/min. Target ablation index is set to 500 at the anterior wall and 350 at the posterior wall of left atrium).
15805115|NCT04408703|Diagnostic Test|Red Density|Image analysis of endoscopic images in patients with ulcerative colitis
15805116|NCT04408690|Procedure|Immediate anterior cruciate ligament reconstruction|"No guidelines on type of ACL reconstruction will be imposed to keep the trial pragmatic. The decision of graft type and surgery technique is a clinical decision made by the orthopaedic surgeons of the participating centra.
~This surgery will be performed within 12 weeks after the ACL injury."
15805117|NCT04408690|Other|Rehabilitation|All patients complete rehabilitation under supervision of their own physiotherapist. The investigators will provide some guidelines and criteria, but it is the physiotherapist's choice how to implement these guidelines in clinical practice.
15805118|NCT04408690|Procedure|Optional delayed anterior cruciate ligament reconstruction|"If a patient complains about persistent symptomatic instability of the knee or the inability to progress in rehabilitation, delayed surgery can be considered. ACL insufficiency induced instability in combination with a positive pivot shift and an additional MRI are needed to confirm the cause of instability.
~This surgery will not be performed within the first 12 weeks after the ACL injury."
15805119|NCT04408677|Device|Zilia Ocular|Measurement of the oxygen saturation in the eye fundus
15805120|NCT04408664|Drug|Sodium Cromoglycate|Sodium Cromoglicate 10 mg/mL packed in ampulla of 2 mL; Daily dosis of 4X20 mg milligram delivered by aerosol.
15805121|NCT04408664|Drug|Placebo|Sodium Chloride 0.9% packed in ampulla of 2 mL; Daily dosis of 4 ampulla delivered by aerosol.
15805122|NCT04408651|Behavioral|LIIT.CI ACT|4-week online self-management intervention based on Acceptance and Commitment Therapy and adapted to people with chronic medical conditions
15805130|NCT04408625|Biological|PR006|Participants will receive a single dose of PR006, administered intra cisterna magna
15805131|NCT04408625|Drug|Methylprednisolone|1-2 IV pulses administered as concomitant medication
15805132|NCT04408625|Drug|Sirolimus|Loading dose, followed by maintenance dose, followed by dose tapering; administered as concomitant medication
15805133|NCT04408625|Drug|Prednisone|Administered orally as concomitant medication, followed by dose tapering.
15805134|NCT04408625|Drug|Rituximab|Single IV pulse administered as concomitant medication.
15805135|NCT04408612|Diagnostic Test|Scales for assessment of symptoms|"Medical Research Council Dyspnea scale, the visual analogue scale of dyspnea, Borg scale, modified dictionary of dyspnea, G. Rose questionnaire, Seattle Angina Questionnaire, Framingham criteria for chronic heart failure, the SHOCK scale."
15805136|NCT04408599|Drug|NC410|NC410 is an experimental antibody drug that may make the immune response more active against cancer
15805137|NCT04408586|Drug|Phentermine-Topiramate Extended Release|Dosing of 3.75/23 mg daily for 15 days, increased to 7.5/46 mg daily
15805138|NCT04408586|Drug|Placebo|Placebo looks exactly like the study drug, but it contains no active ingredient
15805139|NCT04408586|Other|Online support system|VitalCare (VitalTech Affiliates LLC) is a digital health platform that allows remote collection of date from the wearable tracker and digital wellness devices used as part of this study. It also will allow subjects to document study medication compliance and will allow the remote visits to be conducted through a video conference between subjects and appropriate study team members.
15805140|NCT04408573|Other|Cycling deep brain stimulation|Deep Brain Stimulation applied in cycling - periods of stimulation ON intercalated with periods of stimulation OFF
15805141|NCT04408560|Drug|Rhus toxicodendron 9 CH + Ruta graveolens 5 CH (Homeopathic Granules)|Rhus toxicodendron 9 CH + Ruta graveolens 5 CH
15805142|NCT04408560|Other|paracetamol (drug analgesic class1)|paracetamol (drug analgesic class1)
15805143|NCT04408547|Device|embryo transfer catheter|undergoing embryo transfer
15805144|NCT04408534|Other|mode of noninvasive ventilation|administration of during 3 hours each 4 cycles
15805145|NCT04408521|Other|NEUROFEEDBACK|EEG recording during alpha-related TV viewing
15805146|NCT04408521|Other|CONTROL|EEG recording during passive TV viewing
15805147|NCT04408508|Drug|Amoxicillin 250 MG|Low dose oral amoxicillin will be administered to patients enrolled in the study meeting the inclusion and exclusion criteria.
15805148|NCT04408495|Procedure|Intervention group_MRA|"Tidal Volume (Vt) =6-8 mL/kg of predicted body weight (PBW), Peep=8 cmH2O, recruitment maneuvers=30cm H2O every 30 min after intubation (except during CPB), after any disconnection and at the admission in ICU.
~Recruitment maneuvers are performed in accordance with the surgical team an if SAP≥90 mmHg or MAP≥65 mmHg.
~Ventilation is maintained during CPB Vt=2.5 mL/kg, Peep= 5 cmH2O"
15805149|NCT04408495|Procedure|Control group|Vt=6-8 mL/kg of PBW, Peep=5 cmH2O , No recruitment maneuvers. Ventilation maintained during CPB Vt=2.5 mL/kg, Peep= 5 cmH2O.
15805150|NCT04408482|Device|Biliary cannulation|Cannulation of biliary duct by sphincterotome
15805151|NCT04408469|Behavioral|Online EQuIP|This online CBT treatment consists of 10 weekly modules that participants will complete over the course of 10 weeks.
15805152|NCT04408469|Behavioral|Self-monitoring control|Participants will be asked to indicate their past 7-day mood; stress experiences; and mental and behavioral health on an online survey experience once per week for 10 weeks
15805153|NCT04408456|Drug|HCQ|Tablet HCQ 400 mg q 12 hourly on day one followed by 400 mg once weekly for 3 weeks (total cumulative dose of 2000 mg)
15805154|NCT04408456|Other|Standard therapy|Home quarantine for 2 weeks plus social distancing plus personal hygiene
15805155|NCT04408443|Dietary Supplement|Lactobacillus reuteri DSM 17938 + Vitamine D3|Lactobacillus reuteri DSM 17938 (10E8 CFU in 5 drops), Vitamin D3 (400 IU in 5 drops), sunflower oil, medium chain triglycerides, silicon dioxide
15805156|NCT04408443|Dietary Supplement|Placebo|sunflower oil, medium chain triglycerides, silicon dioxide
15805158|NCT04408417|Device|Prototype child safety seat with tension indicator lights|The prototype child safety seat is a convertible rear-facing seat with a harness system that includes tension indicator lights.
15805159|NCT04408417|Device|Control child safety seat|The control child safety seat is a convertible rear-facing seat without tension indicator lights.
15805160|NCT04408404|Procedure|Acute aortic dissection|Acute aortic dissection treatment include Bentall procedure, Tyrone David procedure, Yacoub procedure or ascendant aortic replacement with or without aortic valve replacement, ascendant aortic root remodelling (all are standard of care procedures)
15805161|NCT04408391|Other|Brain MRI scan|Resting state, functional, structural and morphometric MRI; diffusion tensor imaging on a 3-Tesla MRI scanner
15805162|NCT04408378|Other|observation of covid 19 pneumonia|We try to reveal the fact,covid-19 pneumonia prognosis can be estimated by using MPV/PLT ratio
15805163|NCT04408352|Device|selective bladder denervation using RF energy|RF ablation of the trigone for the treatment of UUI
15805164|NCT04408339|Other|No Intervention|No Intervention
15805165|NCT04408326|Drug|Angiotensin II|Exogenous angiotensin II acts on angiotensin II type 1 receptor and raise blood pressure by vasoconstriction, salt and water retention, and stimulation of aldosterone hormone
15805166|NCT04408326|Drug|Interleukin-1 receptor antagonist|Interleukin-1 receptor antagonist is an immunomodulating drug aiming to mitigate cytokine storm in COVID-19 patients
15805167|NCT04408313|Drug|XR-B|Individuals will receive extended-release buprenorphine, administered as a subcutaneous injection, is available in seven different dosage strengths for weekly (8, 16, 24, and 32 mg) and monthly (64, 96, and 128 mg) administration by a health care professional.
15805168|NCT04408313|Drug|XR-NTX|Injectable naltrexone will be used, at a dose of 4cc (380mg of naltrexone), administered by intramuscular injection to the buttocks (alternating sides monthly). Individuals will receive monthly injections.
15805169|NCT04408300|Procedure|Ophthalmological exam|Retinophotography, OCT-A (Optical Coherence Tomography- Angiography), OCT-B scan (Optical Coherence Tomography B Scan), Measurement of corrected visual acuity in ETDRS (Early Treatment Diabetic Retinopathy Study), Measurement of intraocular pressure, adaptive optics
15805170|NCT04408287|Other|WebEx Physical Activity Program|The program will be delivered twice-weekly through 45-minute sessions over 6 weeks. An experienced fitness instructor with lived experience and a graduate student from the Department of Health and Rehabilitation Sciences, will lead a class of 4-6 participants. The sessions will be comprised of a 10-minute warm-up phase, a 25-minute aerobic phase and a 10-minute cool-down phase that will incorporate upper-extremity flexibility exercises and mindfulness meditation. Over the duration the instructor will be sensitive to varying levels of function and fitness and will structure the classes to enable a slow progression of intensity. Individual semi-structured interviews will be completed over the WebEx platform to garner feedback and improve study programming for future implementation of a health care service at Parkwood Institute Outpatient Clinic.
15805171|NCT04408274|Behavioral|Emotional Processing Training|
15805172|NCT04408274|Behavioral|Placebo Control|
15805173|NCT04408261|Drug|Buqitongluo Granule|Buqitongluo Granules were dissolved with boiled water, administered orally, each bag of 10 grams, one bag each time, three times a day for 42 days.
15805174|NCT04408261|Drug|Buqitongluo Granule Placebo|Buqitongluo Granule placeboes were dissolved with boiled water, administered orally, each bag of 10 grams, one bag each time, three times a day for 42 days.
15805175|NCT04408261|Other|Standard care|Guidelines-based standard care for convalescence of ischemic stroke, stable angina pectoris of coronary artery disease or diabetic peripheral neuropathy.
15805176|NCT04408235|Drug|Enoxaparin|Low-Dose LMWH: enoxaparin 4000 IU daily; High dose LMWH: 70 IU/kg twice daily
15805177|NCT04408222|Other|Awake proning|Prone positioning of awake, as tolerated, for up to 24 hours daily.
15805178|NCT04408209|Procedure|Convalescent Plasma|"Convalescent Plasma - early treatment of patients with severe COVID-19. Clinical and laboratory data of patients will be collected before initiation of the procedure, 30 minutes after the first dose, 30 minutes after the second dose and 30 minutes after the third plasma dose and then on days 1-7, 14, 21, 28, 35 from the start of treatment. In case of adverse reactions during transfusion such as acute shortness of breath, haemodynamic instability or high pre-existing and non-disease-related fever, the transfusion will be interrupted and detailed recording of the event as well as updating the Adverse Events Management Committee will be performed.
~In addition to the standard assessments, the titer of neutralizing anti-SARS-CoV-2 antibodies will be measured in a sample drawn prior to plasmapheresis.
~All donors will be tested for:
~the titer of IgG anti-SARS-CoV-2 antibodies (Pasteur Institute)
~the titer of neutralizing anti-SARS-CoV-2 antibodies (Pasteur Institute)"
15805179|NCT04408183|Drug|GLS-1200|GLS-1200 is given as a nasal spray using an atomizer
15805180|NCT04408183|Drug|Placebo|Placebo is given as a nasal spray using an atomizer
15805181|NCT04408170|Diagnostic Test|Point-of-care test for SARS-CoV-2|Throat and nose swabs and/or saliva samples and/or whole blood and/or finger stick samples may be taken to be tested on Point-of-care tests for SARS-CoV-2
15805182|NCT04408157|Behavioral|Self-management booklet (SWitCh: Stay well during COVID-19)|The purpose of this booklet is to support adjustment to the current circumstances of the COVID-19 pandemic and facilitate the development and maintenance of healthy behaviours at home. The booklet covers a range of topics, including understanding bodily sensations and symptoms of COVID-19, managing the uncertainty surrounding COVID-19, physical activity, sedentary behaviour, sleep, social support and isolation, nutrition and alcohol consumption, sex and intimate relationships, and coping with children at home. The booklet will provide structured guidance on the various topics through the use of effective behaviour change techniques, in particular self-monitoring, goal setting, and problem solving and signposting to additional helpful resources, such as drinking or nutrition tracking apps.
15805183|NCT04408144|Drug|Dydrogesterone 10mg Oral Tablet|oral 10mg dydrogesterone (Duphaston) 2 times daily
15805184|NCT04408131|Biological|Blood sample|virological test
15805185|NCT04408131|Biological|Blood sample|serological test
15805186|NCT04408118|Drug|Atezolizumab|"Atezolizumab (840 mg) will be administered intravenously on Days 1 and 15.
~The first infusion of atezolizumab will be administered over 60 minutes. If the first infusion is tolerated, all subsequent infusions may be delivered over 30 minutes."
15805187|NCT04408118|Drug|Paclitaxel|Paclitaxel (90 mg/m2) will be administered on days 1, 8 and 15 via IV infusion over 1 hour.
15805188|NCT04408118|Drug|Bevacizumab|Bevacizumab (Avastin® 10mg/kg) will be administered intravenously over 30-90 minutes on Days 1 and 15.
15805189|NCT04408105|Behavioral|Primary Care Provider Survey|To assess PCP demographics, attitudes, and perceived barriers to BE screening, we have developed a PCP survey using a theoretical model of physician behavior based on Social Cognitive Theory and the Theory of Reasoned Action. This approach has proven effective in colorectal cancer and hepatocellular carcinoma screening. This model includes domains of provider background and experience, screening practices, perceptions of screening, physician influences, and practice environment and practice patterns. To assess PCP knowledge of BE screening, we have designed 9 clinical vignettes that will categorize provider responses into under-, appropriate, and over-use of BE screening. Survey questions and vignettes have been adapted from earlier validated surveys. Prior to distribution, the survey and vignettes will be pretested and refined based on a cognitive interview about the survey among a convenience sample of 10 PCPs.
15805190|NCT04408105|Behavioral|Gastroenterologist Survey|To assess GI demographics, attitudes, and perceived barriers to BE screening, we have developed a GI survey using a theoretical model of physician behavior based on Social Cognitive Theory and the Theory of Reasoned Action. This approach has proven effective in colorectal cancer and hepatocellular carcinoma screening. This model includes domains of provider background and experience, screening practices, perceptions of screening, physician influences, and practice environment and practice patterns. To assess GI knowledge of BE screening, we have designed 9 clinical vignettes that will categorize provider responses into under-, appropriate, and over-use of BE screening. Survey questions and vignettes have been adapted from earlier validated surveys. Prior to distribution, the survey and vignettes will be pretested and refined based on a cognitive interview about the survey among a convenience sample of 10 GIs.
15805240|NCT04407611|Behavioral|Online modality|Return of BRCA results directly online or return of printed BRCA results if participant cannot access online or chooses not to
15805241|NCT04407611|Behavioral|Genetic counselor follow-up|Optional genetic counselor follow-up over the telephone
15805242|NCT04407585|Diagnostic Test|Covid-19 swab PCR test|Participants satisfying machine learning test criteria will be asked to take a swab test for Covid-19.
15805191|NCT04408105|Behavioral|Patient Survey|To assess patient knowledge, attitudes, and barriers to completion of BE screening, we will use a theoretical model of patient behavior on the Health Behavior Framework to guide selection of relevant variables for survey development including 4 domains: knowledge about BE and EAC, potential barriers to BE screening completion, patient attitudes and demographic information. Prior to distribution, the survey will be refined and pretested among a sample of 10 patients with each participant completing a cognitive interview prior to distribution.
15805192|NCT04408092|Drug|Granulocyte Macrophage Colony Stimulation Factor|Recombinant Granulocyte Macrophage Colony Stimulation Factor (rGM-CSF) is a hematopoietic growth factor which supports survival, clonal expansion, and differentiation of hematopoietic progenitor cells. rGM-CSF induces partially committed progenitor cells to divide and differentiate in the granulocyte-macrophage pathways. rGM-CSF stimulates the production of monocytes, granulocytes, erythrocytes, and sometimes, megakaryocytes in the bone marrow. It also induces mature macrophages to increase phagocytosis, superoxide generation, Antibody Dependent Cell-mediated Cytotoxicity (ADCC), tumoricidal killing and cytokine production (IL-1 and tumor necrosis factor). GM-CSF was used in the first successful phase III trial of immunotherapy in the pediatric COG protocol, ANBL0931, a national study in high risk neuroblastoma.
15805193|NCT04408079|Drug|TQB3558|TQB3558 is a kinase inhibitor of the TRK protein family.
15805194|NCT04408066|Diagnostic Test|Sample Collection/Performance Evaluation (A)|"This is a prospective sample collection and performance evaluation study which involves no therapeutic intervention.
~Sample types include:
~Nasal/Throat/Nasal Throat Combo/ Nasopharyngeal (as per sites SOC) Swab
~Whole Venous Blood"
15805195|NCT04408066|Diagnostic Test|Sample Collection/Performance Evaluation (B)|"This is a prospective sample collection and performance evaluation study which involves no therapeutic intervention.
~Sample types include:
~Whole Venous Blood
~Fingerstick Capillary Sample"
15805196|NCT04408053|Device|Preventive fixation of the contralateral femoral neck (Stryker Trauma and Depuy Synthes screws)|6.5mm titanium cannulated self-tapping/self-drilling screws (Stryker Trauma and Depuy Synthes) : 2 screws per patients
15805197|NCT04408040|Biological|Convalescent Plasma|200-425mL convalescent plasma donated by patients previously positive for COVID-19
15805198|NCT04408027|Behavioral|Virtual-Care Cognitive Behavioural Therapy|The feasibility, participation barriers, and acceptability of the intervention, virtual-care cognitive behavioural therapy (VC-CBT), will be evaluated for children with anxiety. The VC-CBT protocol will involve 12 sessions (of one hour in duration) delivered by a CBT therapist using PHIPA (Personal Health Information Protection Act) compliant Zoom. An initial session will review therapy goals and psychoeducation about anxiety. Sessions 2 and 3 will focus on feeling identification and will introduce relaxation strategies. Sessions 4 and 5 will introduce cognitive distortions and restructuring strategies. Sessions 6 and 7 will introduce exposure tasks. Sessions 8 to 11 will involve practicing cognitive restructuring skills and completing exposures. The final session will review relapse prevention. Parents will participate in the first and last sessions, as well as join at the end of each session for a brief review of the skills learned during the session.
15805199|NCT04408014|Diagnostic Test|Serological test|IgM and IgG for SARS-CoV-2
15805200|NCT04408014|Diagnostic Test|Nasopharyngeal Swab|PCR for SARS-CoV-2
15805201|NCT04408014|Diagnostic Test|Oropharyngeal Swab|PCR for SARS-CoV-2
15805202|NCT04408001|Other|Clinical interview|At each study visit, participants will be questioned by a physician about their persistent symptoms or the existence of intercurrent infections that may resemble COVID-19.
15805203|NCT04408001|Biological|Blood collection|"At each study visit,
~1 EDTA tube for complete blood count
~3 dry tubes with gel for serology, serum neutralisation test and serum library
~1 cell preparation tube for the separation of immune cells within the circulating blood will be collected."
15805204|NCT04408001|Biological|Saliva collection|At each study visit, a saliva sample will be collected for the determination of IgA antibodies.
15805205|NCT04407988|Drug|Pyrotinib Maleate plus Letrozole|pyrotinib(400 mg once daily) + Letrozole (2.5 mg once daily)
15805206|NCT04407975|Other|Betamethasone|A single injection will be administered to the patient at least 24 hours before undergoing C-section. This injection will be prepared in the hospital's pharmacy to contain betamethasone
15805207|NCT04407975|Other|Placebo|A single injection will be administered to the patient. This injection will be prepared in the hospital's pharmacy to contain normal saline.
15805208|NCT04407962|Behavioral|SMS group|The experimental treatment will consist of health promoting text messages addressing metabolic risk factors associated with cardiovascular disorders in patients with hypertension. The text messages will be developed to support healthy life style changes i.e. regarding general cardiovascular health, tobacco use, physical activity and diet.
15805209|NCT04407949|Other|CPAP Treatment|Comparing events from the CPAP device with the events scored in PSG
15805210|NCT04407910|Combination Product|AIRFLOW® Master device +Opalescence Xtra Boost.|Prophylaxis techniques for pre-bleaching treatment
15805211|NCT04407910|Combination Product|rubber-cup+Opalescence Xtra Boost.|Prophylaxis techniques for pre-bleaching treatment
15805212|NCT04407897|Radiation|Stereotactic radiotherapy|Three different dose fractionation schemes will be available: 45 Gy in 3 fractions, 50 Gy in 5 fractions, and 60 Gy in 8 fractions.
15805213|NCT04407884|Device|Soovu Labs Inc. Pain Relief System|Longnitual follow-up
15805214|NCT04407871|Other|Acupuncture and Chinese Herbal Medicine|1) acupuncture and CHM, 2) acupuncture and placebo CHM, 3) control acupuncture and CHM or 4) control acupuncture and placebo CHM by an interactive online computer program in a central office. Using a 1:1:1:1 treatment ratio, there will be 682 women assigned to each treatment group.
15805215|NCT04407832|Device|heat probe or hemoclip|for hemostasis
15805216|NCT04407832|Device|heat probe or hemoclip|for hemostasis
15805217|NCT04407819|Radiation|WHOLE BODY DXA|Muscle mass was estimated by using the whole body DXA (Hologic Horizon W)
15805218|NCT04407806|Device|Continous Pulse oximeter|Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation throughout hospitalization
15805219|NCT04407806|Device|Intermittent Pulse oximeter|Pulse oximeter is a small lightweight non-invasive device placed on the fingertip or toe to measure blood oxygen saturation intermittently during hospitalization
15805220|NCT04407780|Other|No interventions are planned|Non applicable
15805277|NCT04407312|Drug|Clopidogrel|Plavix, tablet, 75mg, once daily, 30 days.
15805221|NCT04407767|Behavioral|Case Formulation plus Cognitive Processing Therapy|The CF approach alters the CPT protocol in two ways: expanding the protocol to intentionally and systematically address impairment in functioning, and enhancing the providers' latitude to navigate challenges to optimal therapy outcomes (COTOS). CF-CPT begins with a formal CF assessment session; elements of CF are then integrated throughout CPT. CF modifications to the original CPT protocol occur in each session by intentionally attending to cognitions that are impeding the patient's functional recovery. The second modification includes enhancing the provider's latitude to diverge from the protocol when clinically wise. CF-CPT provides guidance around the identification, monitoring and management of COTOs, and, importantly, the expedient return to the CPT protocol with continued attention to COTOs.
15805222|NCT04407767|Behavioral|Cognitive Processing Therapy|CPT is a brief therapy for PTSD predominantly based on cognitive theory. Traditionally delivered over 12 one-hour sessions weekly or twice weekly, CPT is now variable length depending on patient's recovery from PTSD. CPT is delivered in three phases: education, processing, and challenging and focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. Changing dysfunctional beliefs alters negative emotions emanating from those beliefs.
15805223|NCT04407754|Dietary Supplement|Inositol supplement|Inositol supplements given to inositol arm
15805224|NCT04407754|Dietary Supplement|Placebo supplement|Placebo supplement given to placebo arm
15805225|NCT04407741|Drug|SHR2554+SHR1701|SHR2554: recommended dose from phase I trial, PO, twice a day. SHR1701: 30mg/kg, IV, over 30 minutes
15805226|NCT04407741|Drug|SHR1701|SHR1701: 30mg/kg, IV, over 30 minutes
15805227|NCT04407728|Other|early ultrasound screening|"Women whose fetus is at high risk of congenital heart disease at the end of the 1st trimester screening ultrasound (EchoT1), will benefit from an early heart-centered morphological ultrasound (EchoMorpho-T1) by a referring sonographer between 11 and 14 SA +/- an early fetal cardiac ultrasound (EchoCoeur-T1) between 11 and 15 SA by a cardio-paediatrician in case of EchoMorpho-T1 abnormality.
~The results of the early morphological and cardiac ultrasounds will be compared with those of the 2nd trimester ultrasound at 18-22SA (EchoMorpho-T2) and +/- of the fetal cardiac ultrasound between 18SA and 24SA (Gold standard) or, failing this, with the anatomopathological examination when it is available if a medical termination of pregnancy took place before the EchoMorpho-T2."
15805228|NCT04407715|Procedure|The Effect Of Minimal and High Flow Anesthesia on Optic Nerve Sheath Diamater|The patients were randomly allocated to one of the two groups of fresh gas flows using the closed-envelope technique: 2 L/min high flow and 0.5 L/min minimal flow.
15805229|NCT04407702|Other|Hygiene Instructions|Two weeks prior to the onset of the study, the volunteers will undergo a wash-out period, in which they will only use oral hygiene products donated by the researchers. These products will be used through to the end of the study. The oral hygiene kit will contain a soft-bristle toothbrush (Professional Lab Series, Colgate Palmolive), fluoride toothpaste with no desensitizing agent (Elmex) and dental floss (Colgate). The participants will be extensively trained with regards to all procedures involved in the experiment.
15805230|NCT04407702|Procedure|Sealant application|The teeth to be sealed will be isolated and 35% phosphoric acid will be applied for 20 seconds, followed by rinsing and drying the dental surfaces. A thin layer of PermaSeal will be applied to the tooth surface for 5 seconds and photopolymerized for 20 seconds. The occlusion will then be evaluated.
15805231|NCT04407702|Radiation|Low-level Laser|Irradiation with AsGaAl laser at a wavelength of 780 nm (Laser XT Therapy, DMC, São Carlos, SP, Brazil) with relative isolation. The power will be set to 100 mW; energy density will be 35 J/cm2 (considering a spot size of 0.028 cm2 of the equipment) and the dose will be 1 J per point. Irradiation will be performed on a cervical point, an apical point and a point precisely over the lesion, totaling a dose of 3 J. Treatment will be performed in three sessions with a 72-hour interval between sessions.
15805232|NCT04407689|Drug|Interleukin-7|Intramuscular (IM) administration of CYT107 at 3 μg/ kg followed, after 48hrs of observation, by 10 μg/kg twice a week for 2 weeks or
15805233|NCT04407689|Drug|Placebo|Intramuscular (IM) placebo (normal saline) at the same frequency
15805234|NCT04407676|Other|Summary PIS and Online Video Modules|Complex trial information presented in alternative and more accessible formats
15805235|NCT04407663|Other|Telemedicine to remote outpatient visit in bariatric patient|Patients that referred for the first time to our bariatric center were investigated for anthropometric, psychological and instrumental data in order to evaluate the eligibility for a future bariatric procedure. In established patients, eligibility for tele-consultation was evaluated by three experienced physicians, consulting the stored patients' data. All included patients provided oral informed consent. Patients approached the virtual visit with their personal smart devices, desktop or laptop computer. Medical counselling was performed using a desktop or laptop computer from the Hospital or home in a smart working modality. The video call was carried out using Skype platform by Microsoft®; any document drawn up by the physician was saved as pdf using the Cute Professional™ PDF software, that allows to add passwords and set security options to protect the patients' data.
15805236|NCT04407650|Drug|Metformin|"Patients will be randomized to each intervention using minimisation:
~BMI category (Overweight/Obese),
~Previous history of GDM,
~Disease severity (baseline fasting glucose ≤6.2 or >6.2),
~Recruitment centre"
15805237|NCT04407650|Drug|Ursodeoxycholic Acid|"Patients will be randomized to each intervention using minimisation:
~BMI category (Overweight/Obese),
~Previous history of GDM,
~Disease severity (baseline fasting glucose ≤6.2 or >6.2),
~Recruitment centre"
15805238|NCT04407624|Other|Intermittent Exercise|Exercise programs including warm-up, loading, cooling, and relaxation exercises are shown. The warm-up period is consist of light-paced walking, active movements of several large muscle groups. During the loading period, taking into consideration the heart rate, fatigue and shortness of breath, exercises such as walking, squat, limb movements with weights, stepping on the steps, walking on different floors are shown. Stretching exercises are done during the cooling period. Intermittent loading workouts will consist of 3-minute loads and 1-minute rest intervals. Participants are contacted every two weeks via communication methods such as e-mail, message and telephone conversation. Exercise diary is given to all patients and is taken from them at the end of the study.
15805239|NCT04407624|Other|Control|Exercise programs including warm-up, loading, cooling, and relaxation exercises are shown. The warm-up period is consist of light-paced walking, active movements of several large muscle groups. In loading period, moderate aerobic exercise is consist of brisk walking to reach 60-85% of the person's maximum heart rate. Stretching exercises are done during the cooling period.
15805243|NCT04407572|Other|Serum zinc, vitamin d vitamin b12 levels .|Serum zinc, vitamin d vitamin b12 levels of 45 patients will be measured and evaluated together with the information of the patients.
15805244|NCT04407559|Other|Serological analyses to be lead on a pre-existing biobank|"3 immunoassays will be used according to the procedure described (Demey-2020; Tuaillon-2020) :
~WuHan UNscience Biotechnology Co., Ltd (Chine). COVID-19 IgG/IgM Rapid Test Kit, (Wuhan, China), will be refered as UNscience
~Chongqing iSIA BIO-Technology Co., Ltd (Chine). 2019-nCoV IgM/IgG Diagnostic Test Kit ; (Chongqing, China), will be refered as iSIA
~Xiamen Biotime Biotechnology Co. Ldt (Chine). (SARS-CoV-2) IgM/IgG Rapid Qualitative Test Kit, will be refered as Biotime."
15805245|NCT04407533|Other|Diet tracking and survey|Mobile AI-based food diary application and online questionnaires
15805246|NCT04407520|Other|No patient treatment is associated with the study|No patient treatment is associated with the study.
15805247|NCT04407507|Drug|Ivermectin|ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days
15805248|NCT04407507|Drug|Placebo|Placebo of ivermectin 12 mg / day for 3 days, in combination with standard paracetamol therapy (500 mg QID) for 14 days
15805249|NCT04407494|Biological|Reporting of anosmia, ageusia and other clinical symptoms|Reporting of anosmia, ageusia and other clinical symptoms related to COVID-19 - CODA test - SARS-CoV2 RT-PCR and ELISA
15805250|NCT04407481|Drug|Aminohippurate Sodium Inj 20%|Diagnostic aid/agent used to measure effective renal plasma flow (ERPF)
15805251|NCT04407481|Drug|Iohexol Inj 300 milligrams per milliliter (MG/ML)|Diagnostic aid/agent used to measure glomerular filtration rate (GFR)
15805252|NCT04407481|Radiation|PET/CT Scan|Imaging used to visualize the kidneys and quantify renal metabolic activity
15805253|NCT04407468|Procedure|Prone position|Position of the patient in which he is face down, for an improvement in oxygenation
15805254|NCT04407455|Diagnostic Test|Karaduman Chewing Performance Scale|For chewing evaluation, children will be asked to bite and chew a standardized biscuit. Each chewing evaluation will be scored according to the KCPS.
15805255|NCT04407442|Drug|Azacitidine|Given IV
15805256|NCT04407442|Biological|Daratumumab|Given SC
15805257|NCT04407442|Drug|Dexamethasone|Given IV or PO
15805258|NCT04407429|Diagnostic Test|Laboratory Analyses|Storage of serum for SARS-CoV-2-antibodies and biomarkers
15805259|NCT04407416|Procedure|Breath sampling|The breath of all subjects included will be sampled using a device able to capture the alveolar air and to fix it on carbon tubes, Then the tubes will be desorbed and analysed using gas chromatography
15805260|NCT04407403|Behavioral|Tai Chi tailored for lowering blood pressure (PRESSURE)|PRESSURE Tai Chi routine consisted of eight forms following Yang style. PRESSURE was tailored for the targeted health outcome of BP in consultation with the professional, certified Tai Chi instructor and an experienced physical therapist. Specifically, investigators tailored PRESSURE to emphasize slow, deep breathing and relaxation by utilizing Tai Chi movements that: 1) were slow and smooth; 2) without break or pause; and 3) had minimal muscular force and exertion. Investigators included the following eight forms in PRESSURE: 1) Begin Tai Ji Quan; 2) Part the Horse's Mane; 3) Brush Knee and Push; 4) Cloud Hands; 5) Open and Close; 6) Part the Grass; 7) Single Whip; and 8) Finish Tai Ji Quan.
15805261|NCT04407403|Behavioral|Tai Chi tailored for improving balance (BALANCE)|BALANCE Tai Chi routine consisted of eight forms following Yang style. BALANCE was tailored for the targeted health outcome of balance in consultation with the professional, certified Tai Chi instructor and an experienced physical therapist. Specifically, investigators tailored BALANCE to provide moderate to high levels of challenge to balance control by emphasizing movement principles (e.g., consciously control weight shifting during multi-directional stepping), and integrating Tai Chi movements that: 1) reduced the base of support; 2) moved the center of gravity; and 3) improved lower-extremity strength. Investigators included the following eight forms in BALANCE: 1) Begin Tai Ji Quan; 2) Roll the Ball; 3) Kick with Heel; 4) Repulse the Monkey; 5) Gather the Earth's Qi; 6) White Crane Spread Wing; 7) Fairy Weaves the Shuttle; and 8) Finish Tai Ji Quan.
15805262|NCT04407390|Dietary Supplement|Nicotinamide riboside|The patients will receive 1 g of nicotinamide riboside or placebo orally every morning for 14 days.
15805263|NCT04407390|Dietary Supplement|Placebo|Placebo
15805264|NCT04407377|Drug|Tolperisone Hydrochloride|Study Drug
15805265|NCT04407377|Drug|Cyclobenzaprine Hydrochloride 10 MG|Active Comparator
15805266|NCT04407377|Other|Placebo|Placebo Comparator
15805267|NCT04407364|Device|CoMatryx Surgical Bovine Collagen|The CoMatryx surgical collagen powder is a soft tissue repair product made of 100% type I bovine collagen
15805268|NCT04407351|Device|Green LED light|Investigators arrange 12 weeks green LED light phototherapy.
15805269|NCT04407351|Device|Red LED light (placebo)|Investigators arrange 12 weeks red LED light phototherapy (placebo).
15805270|NCT04407338|Device|B-DYN|The surgical technique for placement of the B-Dyn device is performed under general anaesthesia. The procedure begins with the insertion of the first upper polyaxial screw which is screwed in with the polyaxial screwdriver. The use of the phantom (Trial 10) is necessary in order to position the second screw. Once the screws are positioned, the B-Dyn is taken between the jaws of the gripping forceps in order to insert it into the heads of the polyaxial screws. The movable rod of the B-Dyn is then placed in the head of the upper screw. The positioning mark of the fixed rod must be placed facing the operator and in the center of the lower screw head. Finally the cap of the lower polyaxial pedicle screw is tightened. A final tightening of the two plugs on the polyaxial pedicle screw heads is performed to fix the assembly.
15805271|NCT04407338|Device|Conventional Bolted fusion (with or without cage)|The surgeon will complete his gesture by placing 2 screws in the upper vertebra and 2 screws in the lower vertebra; the screws will be connected to each other to stabilize the assembly. This type of surgery is done via posterior approach and under general anaesthesia.
15805272|NCT04407325|Device|electronic nose device|electronic nose device will be tested as a triage instrument for tuberculosis in a high risk population
15805273|NCT04407325|Device|dig chest Xray with automated readings|software for tuberculosis detection on digital Chest Xray providing a probability score from 0-100
15805274|NCT04407312|Drug|Cilostazol Tablets|Cilostazol-SR, capsule, 200mg, once daily, 30 days.
15805275|NCT04407312|Drug|placebo|Placebo, tablet, 200mg, once daily, 30 days.
15805276|NCT04407312|Drug|Aspirin|Astrix, capsule,100mg, once daily, 30 days.
15805278|NCT04407299|Behavioral|self-administered structured questionnaire|It was designed as a self-administered questionnaire with closed questions (yes/no questions, rating scale and multiple choice questions) and some open ended questions.
15805279|NCT04407286|Dietary Supplement|Vitamin D3|Oral vitamin D3 capsules
15805280|NCT04407273|Drug|observational|observational study
15805281|NCT04407260|Device|Oxygen Hood|High-Flow Oxygen Hood with neck dam and intake and exhaust tubing incorporating a Bacterial/Viral HEPA filter and optional PEEP attachment.
15805282|NCT04407247|Biological|Infliximab|Given IV
15805283|NCT04407247|Biological|Vedolizumab|Given IV
15805284|NCT04407234|Drug|Tirzepatide|Tirzepatide administered SC.
15805285|NCT04407234|Drug|Acetaminophen|Acetaminophen administered orally.
15805286|NCT04407208|Biological|Convalescent plasma|The minimum titer of specific antibody is 1/80
15805287|NCT04407195|Other|Exposure to the SARS-CoV-2|This is an observational design. Participants are exposed to the Covid-19 pandemic.
15805288|NCT04407182|Dietary Supplement|Viusid and Asbrip|"Patients will be randomized to receive daily doses of 30 ml of Viusid and 10 ml of Asbrip every 8 hours plus standard care. Viusid and Asbrip will be administered orally.
~Treatment duration: 21 days."
15805289|NCT04407169|Other|no intervention|There will be no intervention. It is only an observationnal study
15805290|NCT04407156|Other|acute kidney injury|AKI in COVID positive cases
15805291|NCT04407143|Diagnostic Test|IgG test|IgG+ blood test by ELISA method.
15805292|NCT04407130|Drug|Ivermectin + Doxycycline + Placebo|"Arm I: 200 mcg/kg (12 mg tablet) ivermectin (IVERA) single dose and 200 mg stat doxycycline day-1 followed by 100mg doxycycline 12hrly for 4 day (i.e. day2-day5)
~Placebo one tablet D2-5"
15805293|NCT04407130|Drug|Ivermectin + Placebo|Arm II: Ivermectin - 200 mcg/kg (12 mg tablet) once per day D1-D5 + Placebo two tablets D1 followed by Placebo one tablet D2-5
15805294|NCT04407130|Drug|Placebo|Arm III: 3 Placebo tablets D1 followed by 2 tablets D2-5
15805295|NCT04407117|Behavioral|Lock-down and social distancing|Lock-down and social distancing during COVID-19 pandemic
15805296|NCT04407104|Diagnostic Test|skin prick-test|retrospective study on data already collected
15805297|NCT04407091|Drug|14C]AZD4831 Oral Solution|10 mg dose of [14C]AZD4831 Oral Solution
15805298|NCT04407078|Drug|Sugammadex Injectable Product|Sugammadex of 2 mg/kg is injected.
15805299|NCT04407078|Drug|Neostigmine Injectable Product|Neostigmine of 50 ug/kg and Glycopyrrolate of 10 ug/kg are injected.
15805300|NCT04407065|Drug|Double trigger|Final follicular maturation is triggered by the co-administration of GnRH-agonist (Triptorelin acetate, decapeptyl 0.2 mg, Slough, United Kingdom) and 10000 IU of HCG, 40 and 34 h prior to oocyte retrieval, respectively
15805301|NCT04407065|Drug|HCG trigger|Final follicular maturation is triggered by a dose of 10000 IU of HCG 36 h prior to oocyte retrieval
15805302|NCT04407052|Drug|Double trigger|Final follicular maturation is triggered by the coadministration of GnRH-agonist (Triptorelin acetate, decapeptyl 0.2 mg, Slough, United Kingdom) and 10000 IU of HCG, 40 and 34 h prior to oocyte retrieval, respectively
15805303|NCT04407052|Drug|HCG trigger|Final follicular maturation is triggered by a dose of 10000 IU of HCG 36 h prior to oocyte retrieval
15805304|NCT04407039|Device|PET/CT, H-MRS and MRI|Use imaging methods to get metabolic parameters.
15805305|NCT04407026|Biological|biofluids|Gingival crevicular fluid, saliva and serum samples were obtained.
15805306|NCT04407013|Other|Enhanced supportive care based on standardized care pathway|Enhanced supportive care based on standard care pathway is consisted of 1) symptom management (symptom assessment and according management) and 2) coping enhancement (nurse-led counseling). The enhanced supportive care will be provided 5 times, according to the standardized care pathway.
15805307|NCT04407013|Other|Control group with usual care|Control group will receive usual care (symptom monitoring only)
15805308|NCT04407000|Drug|Test: Favipiravir 200 mg (LOQULAR)|Test Drug
15805309|NCT04407000|Drug|Reference: Favipiravir 200 mg (Avigan)|Reference Drug
15805310|NCT04406987|Procedure|decompression|surgical technique for neural decompression varied based on surgeon's preference, but always with preservation for spinous processes. Either open with or without microscope or using tubular retractors.
15805311|NCT04406987|Procedure|fusion|fusion techniques consisted besides decompression of additional implantation of pedicle screws with rods, with or without intervertebral fusion and cage(s). Non-instrumented technique with allograft bone. Fusion technique on surgeon's discretion.
15805312|NCT04406974|Procedure|Surgery or treatment for local recurrence|Surgery or treatment for local recurrence
15805313|NCT04406974|Procedure|Surgery for advanced colorectal cancer|Surgery for advanced colorectal cancer
15805314|NCT04406961|Procedure|Endoscopic transpapillary antegrade sphincterotomy developed by Dr. Dovbenko.|Sph. Oddi consists of a longitudinal and circular smooth muscle layers. Circular muscle fibers form the pancreatic and duodenal parts. Anatomical justification was cutting of only the circular layer of sph Oddi by special sphincterotome. Papillary stenosis and stenosis terminal part of common bile duct due to damage only circular layer sph Oddi. Anterograde direction and hooked form of sphincterotome (endoscopic antegrade sphincterotomy- ASD) allows to capture only need layer and control depth. Also ASD was performed patient with SOD (I-III) with preservation of the longitudinal muscular layer sph Oddi and septum of papilla.
15805315|NCT04406961|Device|The antegrade sphincterotome developed by Dr. Dovbenko.|A device is represented by a teflon catheter in the distal part of which a double tube of variable shape is created. The proximal part of the ASD sphincterotome consists of a handle, and a metal wire is located inside the teflon catheter for connection to an electrosurgical unit. On the distal part, the teflon catheter is formed of a double tube length is 10 to 35 mm. The metal wire exits the catheter at a distance 10 to 35 mm from the tip and enters into the tip the second teflon tube. The distal part of the knife is formed shape a hook. A metal cutting wire is located between two tubes. Moving the handle the metal wire is shifted. Pushing the metal wire or approaching in the distal part the second tube sets the depth of cut. The incision is made by moving on guidewire in bile duct. The power settings vary.
15805392|NCT04406272|Drug|Bevacizumab|A type of antibody, Bevacizumab is intravenously administered and works by binding to and disrupting the vascular endothelial growth factor (VEGF). VEGF is a signal protein produced by cells that stimulates the formation of blood vessels. By disrupting VEGF, Bevacizumab helps to prevent the growth and maintenance of tumor blood vessels.
15805316|NCT04406961|Procedure|Endoscopic sphincterotomy.|Endoscopic standard sphincterotomy aims at opening bile duct or pancreatic duct by cutting the papilla and sphincter muscles. After deep bile duct cannulation, the standard sphincterotome is retracted until one fourth to one half of the wire length is exposed outside the papilla. The sphincterotome is slightly bowed so that the wire is in contact with the roof. The incision is made lifting the sphincterotome against the papillary roof using the elevator and up-down controls while applying short bursts of current. The power settings vary. The extent of the sphincterotomy is limited by the length of the intraduodenal portion of the common bile duct.
15805317|NCT04406961|Device|The standard sphincterotome.|"The standard sphincterotome, the Erlangen pull-type model, consists of a catheter containing a cautery wire exposed 15 to 25 mm near the tip of the instrument. The leading tip distal to the wire, the nose, is 5 to 10 mm in diameter. After deep bile duct cannulation, the sphincterotome is retracted slowly, until one fourth to one half of the wire length is exposed outside the papilla. The sphincterotome is slightly bowed so that the wire is in contact with the roof. The incision is made by lifting the sphincterotome against the papillary roof using the elevator and up-down controls while applying short bursts of current. The power settings vary."
15805318|NCT04406948|Drug|MGCND00EP1|Patients will take cannabis oil during the study
15805319|NCT04406948|Drug|Placebo|Patient will take carrier oil during the study
15805320|NCT04406948|Diagnostic Test|ECG|"A standard 12-lead ECG will be recorded using digital ECG recording equipment provided to the investigational site. The ECG has to be performed prior to laboratory samplings at time points indicated in the Schedule of Assessments.
~The ECG recording will be reviewed by investigator and case of need consultation with cardiologist will be performed. The investigator has the final decision on the clinical significance of the ECG results."
15805321|NCT04406948|Diagnostic Test|EEG|An EEG is an electrophysiological monitoring method that records the electrical activity and measures voltage fluctuations resulting from ionic current within the neurons of the brain. In clinical contexts, EEG refers to the recording of the brain's spontaneous electrical activity over a period of time.
15805322|NCT04406948|Diagnostic Test|Blood and urine collection|safety blood tests - hematology\blood count and biochemistry standard blood tests urinalysis - urine test analysis
15805323|NCT04406935|Device|treatment with the study device (NuEra)|"Multi-arm, prospective, multi-center, baseline-controlled study:
~Arm 1: NuEra treatment using 475 KHz Arm 2: NuEra treatment using 1 MHz Arm 3: NuEra treatment using 2 MHz"
15805324|NCT04406922|Procedure|Personalized cooling protocol|As an intervention, a personalized cooling protocol will be used in order to activate BAT and induce non-shivering thermogenesis. During the cooling procedure, subjects will be exposed to mild cold (approx. 14°C) for 150 min. Since the onset temperature of shivering shows a high interindividual variation, we will use a personal cooling protocol to ensure maximum non-shivering EE (and thus an equal maximum activation of BAT). The right temperature will be determined via a subjective method, e.g. to ask the subject if he or she experiences shivering. The time needed to achieve the right temperature is approximately 30-60 minutes. Then, the stable cooling period of 90 min is started. During this time the subject will be asked every 15 minutes whether he is experiencing shivering. If so, temperature will be increased with 2-3°C so that shivering just stops.
15805325|NCT04406909|Other|Access to training facility|Access to training facility under national regulations for COVID control
15805326|NCT04406896|Drug|Selatogrel|A single subcutaneous injection of 16 mg.
15805327|NCT04406883|Drug|Extraction + filled with Simvastatin solution impregnated gelatin sponge|All two first premolars were extracted carefully, have used periotome as a means of atraumatic extraction that facilitated the removal of teeth with minimum damage to the surrounding alveolar bone, teeth to be extracted should have minimum periapical changes radiographically; with decreasing soft tissue reflection; the socket was tan gently irrigated with normal saline and hemostasis was achieved. It must be noted that A group (Extraction + filled with Simvastatin (Poursina Pharmaceutical Co. Tehran-Iran) solution impregnated gelatin sponge (Maquira Industry Dental Products S.A. Brazil) and B group (Extraction + without Simvastatin solution impregnated gelatin sponge), was placed in one of the sockets.
15805328|NCT04406870|Drug|Sirolimus Oral Product|Patients with IHHE wil be treated with propranolol (1 mg / kg , twice a day, after meals), and then evaluation will be performed after 3 months (changes of the tumor size measured by ultrasound examination, and changes of tumor volume measured by abdominal enhancement CT).It will be admitted into the group once the tumor volume shrinks <30%.Then propanolol combined with sirolimus will be given. Propranolol will be given at 1mg/kg,twice a day and sirolimus will be given at 0.8mg/m²(body surface area), twice a day. Recording and doing assessment of tumor size, adverse effects as well as complicated symptoms.
15805329|NCT04406870|Drug|propranolol|Patients with IHHE wil be treated with propranolol (1 mg / kg , twice a day, after meals), and then evaluation will be performed after 3 months (changes of the tumor size measured by ultrasound examination, and changes of tumor volume measured by abdominal enhancement CT).It will be admitted into the group once the tumor volume shrinks <30%.Then propanolol combined with sirolimus will be given. Propranolol will be given at 1mg/kg,twice a day and sirolimus will be given at 0.8mg/m²(body surface area), twice a day. Recording and doing assessment of tumor size, adverse effects as well as complicated symptoms.
15805330|NCT04406857|Drug|Capecitabine|Given PO
15805331|NCT04406857|Radiation|Radiation Therapy|Undergo radiation therapy
15805332|NCT04406857|Drug|Ropidoxuridine|Given PO
15805333|NCT04406831|Procedure|Blood draw|Individuals in the unresectable pancreatic cancer group will receive monthly blood draws. Individuals in the control group will receive one blood draw
15805334|NCT04406818|Drug|Carbon Dioxide|Participants inhale carbon dioxide while in magnetic resonance imaging scan to measure cerebrovascular reactivity
15805335|NCT04406805|Diagnostic Test|Measurement of plasma and urine trimethylamine-N-oxide concentration|Information already included in arm/group descriptions.
15805339|NCT04406779|Device|thyroid USG was perform, blood samples were taken for the meausurement of thyroid hormone and autoantibodies|thyroid USG was perform, blood samples were taken for the meausurement of thyroid hormone and autoantibodies
15805524|NCT04405206|Behavioral|Quality of Life Questionnaires|QLQ C30 and QLQ CR29
15805340|NCT04406766|Device|Connected nutrition pump system|"For the patient, it consists of the installation of the connected pump at his home for a duration of one month.
~Infusion data and events will be continuously collected and transmitted by the 4 different modes (LoRaAN, BLE , GSM and multimodality).Transmitted data won't be used to change the follow up of the patient.
~At the end of the month, patients will be solicited by an ergonomic engineer to complete a specific questionnaire in order to evaluate the future acceptability of the proposed solution."
15805341|NCT04406753|Other|Manual therapy techniques in C0-1 and C2-3 with cervical exercise|Manual Therapy + Exercise group will carry out 20-minute session of treatment. The techniques will be applied depending on the clinical findings in each patient and the objective will be to restore the function of C0-1 and C2-3 segments before applying cervical exercises. We will use manipulation (high velocity low amplitude) and/or mobilization (low velocity high amplitude) techniques of C0-1 and C2-3 segments with cervical exercise. Manipulations will be in the direction of traction, with the head in a neutral position. A maximum of two trials at each level on each side will perform (2-6 thrusts). Mobilization will be performed for 5 minutes using repeating cycles of 45 seconds of mobilization and 15 seconds of rest. The cervical exercise will perform by this group will follow the same methodology as the Exercise group.
15805342|NCT04406753|Other|Cervical Exercise|"This group will perform the cervical stabilization exercise. They will be teach to perform the contraction of deep neck flexor muscle activity with the help of the Stabilizer Pressure Biofeedback Unit (Chattanooga, USA) in supine. Exercise will be always carry out without pain, because pain can be an inhibitor of muscle contraction.
~The Exercise group will carry out one 20-minute session, composed of 2 sets of 10 repetitions, holding each repetition for 10 seconds, a 40-second rest between each repetition and 2 minutes between sets."
15805343|NCT04406740|Device|TwitchView EMG Unit|The TwitchView device is a new generation electromyographic monitor that uses a disposable electrode array that combines stimulating and recording electrodes.
15805344|NCT04406740|Device|Novel QTOF Device|The QTOF consists of an electrical stimulator that is just like the stimulator in the traditional TOF devices that are commonly used (both accelerometric and EMG-based), combined with a novel sensor that sticks to the belly of the muscle being measured (most commonly the adductor pollicis, the thumb muscle in the palm of the hand).
15805345|NCT04406727|Biological|UB-421|UB-421 in combination with their ARV
15805346|NCT04406727|Other|Antiretroviral (ARV)|Antiretroviral (ARV)
15805347|NCT04406714|Behavioral|Mailed FIT Outreach|The study team will mail participants an introductory letter advising them that they should expect to receive a FIT kit in the mail. Next, the study team will mail participants a packet that includes a cover letter, CRC information sheet, FIT instruction sheet, and FIT kit consisting of sample collection materials and a pre-paid return envelope. Participants will receive up to two mailed letters reminding them to complete and return the FIT. Participants will receive their FIT results via letter or phone call.
15805348|NCT04406701|Other|Ceres|This will be a self-administered survey on eating habits and their relationship to coping strategies and economic level among nurses.
15805349|NCT04406675|Other|neuropsychological test|neuropsychological test
15805350|NCT04406649|Drug|Dihydroergotamine|Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
15805351|NCT04406623|Drug|SL-172154|The investigational product (IP), SL-172154, is a novel fusion protein consisting of human SIRPα and CD40L (SIRPα -Fc-CD40L) linked via a human Fc.
15805352|NCT04406610|Biological|GD2 CAR-T immunotherapy|Antigen-specific T cell therapy
15805353|NCT04406597|Device|the New Tissue Containment System|Laparoscopic Ovarian Cystectomy using the New Tissue Containment System
15805354|NCT04406584|Procedure|Injection into olfactory cleft|Already stated above.
15805355|NCT04406571|Other|Data record|Data record
15805356|NCT04406558|Other|Questionnaire|An online questionnaire on the experience of the period of confinement and deconfinement will be sent to the cohort of adolescents followed at the CHI Creteil for a chronic disease or not. Forty adolescents will be randomly selected for a remote interview on the experience and memorization of the period of confinement and deconfinement.
15805357|NCT04406545|Other|evaluation of skin microvascular flow and reactivity|evaluation of skin microvascular flow and reactivity using laser Doppler perfusion monitoring
15805358|NCT04406532|Behavioral|PT-Pal|"Participants will be guided through an exercise program in the PT-Pal app. The program is stratified into 3 levels. Participants begin with Level 1 exercises to prevent atelectasis, strengthen inspiratory and expiratory muscles. Gradually exercises to stretch limb and chest wall muscles, build sitting tolerance and to improve transfer ability are added. These exercises can improve respiratory vital capacity. Level 2 focuses on sitting tolerance, strengthening limb and accessory muscles of breathing. Level 3 focuses on standing balance, large muscle strengthening, and building cardiopulmonary endurance.
~Each exercise is done 2-3 times, and gradually increased to a complete set of 8. Each set is then repeated 2-3 per day, building up tolerance and fitness. Duration of session varies from 10 min initially up to 45 min later depending on fitness."
15805359|NCT04406532|Behavioral|Self-guided exercises|"Participants will use the exercise manual to guide the exercise program. The program is stratified into 3 levels. Participants begin with Level 1 exercises to prevent atelectasis, strengthen inspiratory and expiratory muscles. Gradually exercises to stretch limb and chest wall muscles, build sitting tolerance and to improve transfer ability are added. These exercises can improve respiratory vital capacity. Level 2 focuses on sitting tolerance, strengthening limb and accessory muscles of breathing. Level 3 focuses on standing balance, large muscle strengthening, and building cardiopulmonary endurance.
~Each exercise is done 2-3 times, and gradually increased to a complete set of 8. Each set is then repeated 2-3 per day, building up tolerance and fitness. Duration of session varies from 10 min initially up to 45 min later depending on fitness."
15805360|NCT04406506|Device|nasogastric|• The insertion of NG tubes were performed by the ICU physician and the position was checked by auscultation of gas from 50 ml syringe by injecting 20 ml of air in the NG and by X-ray abdomen to be sure from the site of NG tube
15805361|NCT04406506|Device|nasojejunal|"The nasojejunal tube is silicone or polyurethane tube with an inner stylet that is positioned (under fluoroscopic guidance) beyond the ligament of Treitz.
~Patients were placed in right lateral position"
15805362|NCT04406506|Drug|(erythromycin 250 mg IV bolus)|prokinetic (erythromycin 250 mg IV bolus) given to assist the passage of the tube through the pylorus
15805444|NCT04405765|Device|NPWT and cryopreserved Stravix|Subjects will be treated with NPWT and lyopreserved Stravix
15805363|NCT04406493|Diagnostic Test|Lung impedance technique|"COVID 19 patients are admitted to the Infectious Diseases Unit; they will undergo examination using a lung impedance device. The first value that has been measured will be set as BASAL.
~During the hospitalization, each patient will undergo this examination twice a day until discharge.
~Changes in impedance values during admission will be evaluated as POSITIVE AND NEGATIVE PREDICTIVE values for clinical deterioration and improvement of COVID 19 patients and as a factor which predicts mechanical ventilation.
~The time between lung impedance started to decrease (expression of the lung fluids accumulation), and the need for mechanical ventilation will be measured."
15805364|NCT04406480|Genetic|CGH-array and exome sequencing|A blood sample will be used for CGH-array and exome sequencing
15805365|NCT04406467|Device|Xen Gel Stent|Ab-interno or Ab-Externa Xen with closed or open conjunctiva.
15805366|NCT04406454|Device|ApolloVue® S100 Image System|The device is an in vivo non-invasive optical coherence tomography and will be used to obtain at least 3 quality OCT images of B-scan (cross-section) and E-scan (en face) with 4 depths for each skin site respectively for each skin site. There is a total of 6 skin sites.
15805369|NCT04406428|Procedure|NKI followed by EBD|Needle-knife incision therapy followed by endoscopic bougie dilation
15805372|NCT04406402|Behavioral|Acute dietary protocols and lifestyle modification|The investigators tested the effects on serum Arg and ADMA of a) a single load of ingested dextrose, protein, fat or alcohol, each consumed within 10 minutes; b) a single episode of physical exercise; c) a 12 weeks lifestyle modification program comprised of a standard dietary and physical activity counseling in obese or T2DM subjects on circulating Arg and ADMA (n=43).
15805373|NCT04406389|Drug|Enoxaparin sodium|"Intermediate Dose Prophylaxis Arm:
~0.5 mg/kg subcutaneously every 12 hours if creatinine clearance greater than or equal to 30 ml/min --OR-- 0.5 mg/kg subcutaneously every 24 hours if creatinine clearance less than 30 ml/min
~Therapeutic Dose Anticoagulation Arm:
~1 mg/kg subcutaneously every 12 hours"
15805374|NCT04406389|Drug|Unfractionated heparin|"Intermediate Dose Prophylaxis Arm:
~7,500 units subcutaneously every 8 hours
~Therapeutic Dose Anticoagulation Arm:
~Dosed to target anti-Xa level 0.3 - 0.7 IU/mL or activated partial thromboplastin time (aPTT), according to institutional protocol"
15805375|NCT04406389|Drug|Fondapariniux|"Intermediate Dose Prophylaxis Arm:
~2.5 mg daily subcutaneously
~Therapeutic Dose Anticoagulation Arm:
~Dose by weight:
~If greater than or equal to 100 kg: 10 mg daily
~If less than 100 kg but greater than or equal to 50 kg: 7.5 mg daily
~If less than 50 kg: 5 mg daily"
15805376|NCT04406389|Drug|Argatroban|"Therapeutic Dose Anticoagulation Arm:
~Dosed according to institutional protocol"
15805377|NCT04406376|Drug|Prednisone tablet|Treatment of Bell's Palsy with prednisone, with or without tapering down.
15805378|NCT04406363|Other|non interventional|non interventional
15805379|NCT04406350|Procedure|Intraoperative tight control of respiratory end-tidal gases|Control of ET CO2 and ET O2 during conduct of anesthesia.
15805380|NCT04406337|Device|Low intensity pulsed ultrasound|Low intensity pulsed ultrasound therapy will use ultrasound with frequency of 1.5 MHz, power intensity of 30 mW/cm^2 (0.03 W/cm^2 ) and 20% duty cycle.
15805381|NCT04406337|Device|High intensity continuous ultrasound|High intensity continuous ultrasound therapy will use ultrasound with frequency of 1 MHz, power intensity of 3 W/cm^2 and 100% duty cycle.
15805382|NCT04406324|Other|No intervention|No Intervention. The study consists in a prospective clinical longitudinal follow-up
15805383|NCT04406298|Procedure|small quantity paracentesis|Intermittent small quantity paracentesis (upto 3L/day) for upto 5 days
15805384|NCT04406298|Procedure|Large Volume Paracentesis|Large Volume Paracentesis > 5litres
15805385|NCT04406285|Other|Standard protocol Leukemia|"Bicycle ergometer endurance training for 5 minutes, with resistance individually adjusted based on the patient´s feedback (from 70% of maximum heart rate);
~Resistance exercises for muscle groups: hip flexors, knee extensors and ankle plantar flexors (10 repetitions, 1 sets);
~Resistance training for arms, using 0,5 kg or 1,0 kg dumbbels (10 repetitions, 1 sets)."
15805386|NCT04406285|Other|Periodic Resistance Training Program Leukemia|"Submaximal Ergometer tests with incremental load (from 85% of maximum heart rate or maximum effort related);
~30-Second Chair Stand;
~Hand Grip Strength and submaximal arm effort using 0,5 kg or 1,0 kg dumbbels."
15805387|NCT04406285|Other|Standard protocol Lymphoma|"Bicycle ergometer endurance training for 5 minutes, with resistance individually adjusted based on the patient´s feedback (from 70% of maximum heart rate);
~Resistance exercises for muscle groups: hip flexors, knee extensors and ankle plantar flexors (10 repetitions, 1 sets);
~Resistance training for arms, using 0,5 kg or 1,0 kg dumbbels (10 repetitions, 1 sets)."
15805388|NCT04406285|Other|Periodic Resistance Training Program Lymphoma|"Submaximal Ergometer tests with incremental load (from 85% of maximum heart rate or maximum effort related);
~30-Second Chair Stand;
~Hand Grip Strength and submaximal arm effort using 0,5 kg or 1,0 kg dumbbels."
15805389|NCT04406272|Drug|VB11|Intravenously administered type of gene therapy that works by blocking the process of blood-vessel creation. Disrupting a cancer from growing blood vessels, might slow the growth of the cancer or shrink it.
15805390|NCT04406272|Procedure|Surgery|Treatment of disease or injury by cutting, abrading, suturing, or otherwise physically changing body tissues and organs.
15805391|NCT04406272|Other|Placebo|Intravenous solution that has no therapeutic effect, used as a control in testing investigational drug.
15805445|NCT04405752|Device|12-mm metallic biliary stent|Metallic biliary stent, covered or uncovered,KEBOMED HILZO 12mm in diameter (length 4 or 6 cm).
15805393|NCT04406259|Drug|Verapamil|"Patients in groupe A require verapamil initiation as a preventive treatment and patients in group B are patients already undergoing a verapamil treatment for their Cluster Headache.
~The doses of verapamil are increased for the patients in group A, after a clinical examination an electrocardiogram, and a blood test."
15805394|NCT04406246|Drug|Nitazoxanide 500Mg Oral Tablet|Health workers affected by SARS-CoV-2 will receive the next doses of nitazoxanide: 500 mg every 6 hour for two days and then every 12 hours for four days.
15805395|NCT04406220|Other|Small clog size|Participants will be randomized to run in small clogs
15805396|NCT04406220|Other|Large clog size|Participants will be randomized to run in large clogs
15805397|NCT04406207|Other|Demonstration of T cell responses|"Evaluation of HERVs-specific CD8+ T cells before and after hematopoietic stem cell transplantation. Comparison will be made in patients relapsing vs non relapsing patients.
~The measurement of these responses will be done by dextramer, allowing precise and specific measurement of the lymphocytes directed against the HERVs of interest."
15805398|NCT04406194|Drug|FAVICOVIR 200 mg Film Tablet|FAVICOVIR 200 MG FT is containing 200 mg favipiravir manufactured by Atabay, Turkey.
15805399|NCT04406194|Drug|AVIGAN 200 mg Film Tablets|AVIGAN 200 mg FT is containing 200 mg favipiravir manufactured by Toyama, Japan.
15805400|NCT04406181|Behavioral|HADS|Hospital Anxiety and Depression Scale
15805401|NCT04406181|Behavioral|a survey|made up specifically for issues concerning the medical/psychological/access aspects during the COVID-19 outbreak
15805402|NCT04406168|Procedure|urinary diversion|follow up outcomes of urinary diversion
15805403|NCT04406155|Procedure|3D-RWC-TVS with bowel preparation|"Rectal water contrast transvaginal ultrasonography is based on the distention of rectosigmoid with saline solution. Three-dimensional reconstructions convert standard 2D grayscale ultrasound acquisitions into a volumetric dataset.
~Bowel preparation is based on a low-residue diet given in the two days before the examination and a rectal enema administered a few hours before the procedure."
15805404|NCT04406155|Procedure|3D-RWC-TVS without bowel preparation|Rectal water contrast transvaginal ultrasonography is based on the distention of rectosigmoid with saline solution. Three-dimensional reconstructions convert standard 2D grayscale ultrasound acquisitions into a volumetric dataset.
15805405|NCT04406142|Device|VISUAL|thin catheter insertion between vocal cords under direct specially adapted videolaryngoscopy
15805406|NCT04406129|Biological|FMT capsules|Intervention: FMT capsules containing extensively screened donor stool.
15805407|NCT04406129|Other|Placebo capsules|Intervention: Placebo capsules that do not contain donor stool or any active drug.
15805408|NCT04406116|Device|Microwave coagulation using HS1 Instrument|Microwave therapy at 5.8 GHz
15805409|NCT04406103|Behavioral|Sleepwell|Information intended to support capability, opportunity, and motivation for stopping sleeping pill use and using non-pharmacological approaches to managing insomnia.
15805410|NCT04406103|Behavioral|Empower|Information intended to support capability, opportunity, and motivation for stopping sleeping pill use and using non-pharmacological approaches to managing insomnia.
15805411|NCT04406090|Other|Mechanical Trombectomy|Stent retriever for treatment of cerebral arterial occlusions
15805412|NCT04406077|Device|Ligasure|Using ligasure to treat hydrocele
15805413|NCT04406064|Biological|Viral Specific T-cells (VSTs)|VSTs will be infused into study participants who have evidence of SARS-CoV-2 infection.
15805414|NCT04406051|Procedure|norepinephrine infusion and colloid preloading (NOR-COL)|in parturients allocated to the NOR-COL group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive 5 mL/kg of colloid infusion prior to the initiation of spinal anesthesia
15805415|NCT04406051|Procedure|norepinephrine infusion and crystalloid co-loading (NOR-CRYST)|in parturients allocated to the NOR-CRYST group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated. This group will also receive 10 mL/kg of crystalloid infusion simultaneously with the initiation of spinal anesthesia
15805416|NCT04406025|Procedure|participation in Regional Anesthesia Seminar|this group of anesthesiologists attended the Regional Anesthesia Seminar
15805417|NCT04406025|Procedure|no participation in Regional Anesthesia Seminar|this group of anesthesiologists did not attend the Regional Anesthesia Seminar
15805418|NCT04406012|Procedure|paravertebral block|paravertebral block group
15805419|NCT04405999|Drug|Bromhexine Hydrochloride|Medical personnel at risk for COVID-19 infection will receive study medication for 14 days
15805420|NCT04405986|Procedure|Auditory Evoked Potentials (AEP)|Record of electrophysiological responses (Auditory Evoked Potentials or AEP) during auditory stimulations with an electroencephalogram (EEG).
15805421|NCT04405986|Procedure|Blink and Masseter Inhibitory Reflex|Electrophysiological exploration while stimulating trigeminal nerve to record 1) motor response induced (muscle contraction delay (Blink)) of the facial nerve, or 2) the contraction inhibition of masseters (Masseter Inhibitory Reflex (MIR)).
15805422|NCT04405973|Device|vv-ECMO|vv-ECMO required in severe COVID-19 ARDS
15805423|NCT04405960|Drug|Alfacalcidol 1 MCG Oral Capsule|The subjects in the intervention group were given 1 µg oral capsule alphacalcidol once daily Subjects in the control group were given placebo once daily with similar capsule shape and color to the capsule given to the intervention group. The process of alphacalcidol and placebo encapsulation were carried out by pharmacists in the pharmacy depot under the supervision of researchers and CRO Equilab. Alphacalcidol and placebo were put into plastic pots containing 30 capsules for every 4 weeks for each subject. The pot had an etiquette written explaining how to consume the drug (after breakfast between 7 - 10 a.m.). The drugs' packaging and code numbering were carried out by CRO Equilab to ensure a double-blind procedure. As a control, each subject was equipped with a monitoring card. Alphacalcidol and placebo were given for 12 weeks without interruption. Monitoring of compliance and side effects was performed by physicians every 2 weeks.
15805446|NCT04405752|Device|10-mm metallic biliary stent|Biliary, metallic, covered or uncovered stent, COOK EVOLUTION 10mm in diameter (length 4 or 6 cm)
15805447|NCT04405739|Drug|EIDD-2801|Oral capsule of EIDD-2801
15805448|NCT04405739|Drug|Placebo|Oral placebo capsule
15805449|NCT04405713|Procedure|from the onset of symptoms within the first 3 days|ELC within 3 days of onset of ACC
15805450|NCT04405713|Procedure|: from the onset of symptoms within the 4-7 days|ELC 4-7days of onset of ACC
15805424|NCT04405960|Drug|Sugar pill|The subjects in the control group were given placebo containing simple sugar oral capsule once daily with similar capsule shape and color to the capsule given to the intervention group. The process of alphacalcidol and placebo encapsulation were carried out by pharmacists in the pharmacy depot under the supervision of researchers and CRO Equilab. Alphacalcidol and placebo were put into plastic pots containing 30 capsules for every 4 weeks for each subject. The pot had an etiquette written explaining how to consume the drug (after breakfast between 7 - 10 a.m.). The drugs' packaging and code numbering were carried out by CRO Equilab to ensure a double-blind procedure. As a control, each subject was equipped with a monitoring card. Alphacalcidol and placebo were given for 12 weeks without interruption. Monitoring of compliance and side effects was performed by physicians every 2 weeks.
15805425|NCT04405947|Procedure|Reverse Shoulder Arthroplasty|implantation of a reversed shoulder prostheses through two different surgical approaches
15805426|NCT04405934|Other|Use of virus (Covid-19) genome sequence report to inform infection prevention control procedures|Rapid or standard (time to return to sites) receipt of virus (Covid-19) genomic sequencing reports
15805427|NCT04405921|Drug|Hydroxychloroquine 200 Mg Oral Tablet|orally or via gastric tube
15805428|NCT04405921|Drug|Azithromycin 250 MG|orally or via gastric tube
15805429|NCT04405908|Biological|SCB-2019|SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22).
15805430|NCT04405908|Biological|SCB-2019 with AS03 adjuvant|SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with AS03 adjuvant.
15805431|NCT04405908|Biological|SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant|SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with CpG 1018 plus Alum adjuvant.
15805432|NCT04405895|Other|Breakfast Diet|Breakfast Diet (3Mdiet) consist on high-energy breakfast and reduced in energy and carbohydrate (CH) dinner. Participants fasting serum to provide serum to for the in ex-vivo cell studies, will be collected at fasting (8:00), at start (day 0), after 2 weeks and at the end of 3Mdiet intervention (12 weeks). The participants serum is added to culture medium (as serum conditioned medium) to treat during 48 hours the cultured hepatocytes. After 48 hours of serum treatment, the mRNA extraction for the assessment of SIRT1 and Clock Gene expression will be performed at 00:00, 06:00, 12:00 and at 18:00 to assess SIRT1 and the Clock Genes circadian oscillation in hepatocytes. The 3Mdiet efficacy on reducing the overall glycemic excursions is assessed with continuous monitoring system at baseline after 2 weeks month of diet intervention.
15805433|NCT04405895|Other|Allday Diet|Allday Diet (6Mdiet) consist in 6 small meals: breakfast, lunch and dinner and 3 snacks, with calories and carbohydrates (CH) evenly distributed throughout the day. Participants fasting serum to provide serum to for the in ex-vivo cell studies, will be collected at fasting (8:00), at start (day 0), after 2 weeks and at the end of 6Mdiet intervention (12 weeks). The participants serum is added to culture medium (as serum conditioned medium) to treat during 48 hours the cultured hepatocytes. After 48 hours of serum treatment, the mRNA extraction for the assessment of SIRT1 and Clock Gene expression will be performed at 00:00, 06:00, 12:00 and at 18:00 to assess SIRT1 and the Clock Genes circadian oscillation in hepatocytes. The 6Mdiet efficacy on reducing the overall glycemic excursions is assessed with continuous monitoring system at baseline after 2 weeks month of diet intervention.
15805434|NCT04405882|Procedure|topographic guided trans epithelial excimer laser|In this retrospective study 8 eyes affected by cornea ectasia of 8 patients (mean age 31.50±14.73 years) underwent simultaneous CCR and CXL. Preoperative and 6 month postoperative uncorrected distance visual acuity (UDVC) and distance corrected visual acuity (DCVA) were measured using the Efficacy and Safety index. Objective and subjective quality of vision were respectively evaluated through preoperative and 6 month postoperative corneal morphological irregularity index (CMI), National Eye Institute Visual Function NEI-VFQ25 and NEI-VFQ39 questionnaires.
15805435|NCT04405856|Device|Intra Aortic Balloon Pump|Intra Aortic Balloon Pump (IABP) is a circulatory mechanical support device, placed in descending aorta, distally from left subclavian artery and proximally from renal artery. IABP works with counterpulsation concept, synchronized with heart cycle.
15805436|NCT04405843|Drug|Ivermectin Oral Product|Ivermectin oral suspension, 6 mg/mL
15805437|NCT04405843|Drug|Placebo|Substance with similar physical and organoleptic characteristics as ivermectin, without the active drug ingredient
15805438|NCT04405830|Procedure|Renal replacement therapy|Renal replacement therapy (RRT) refers to modalities of treatment that are used to replace the waste filtering functions of a normal kidney.
15805439|NCT04405817|Device|ECMO|ECMO for circulatory and/or respiratory support
15805440|NCT04405804|Drug|Ivabradine 5Mg Tab|"Initial dose of ivabradine will be:
~0.02 mg/kg/dose twice daily in patients between 6-12 months 0.05 mg/kg/dose twice daily in patients between 1-3 years and 3-18 years with a weight < 40 kg 2.5 mg/day in patients between 3-18 years with weight > 40 kg During titration phase, the dose may be increased, maintained, reduced or discontinued in accordance with titration rules. The titration rules will be adjusted on the basis of age subset and of each patient's evaluation during the titration phase, whether or not the target heart rate is reached (HR ≥ 20% compared to baseline HR) and whether or not are present bradycardia (HR should be greater than predefined by a HR threshold per age subset) and/or bradycardia-related symptoms.
~Maximum dose to be reached will be:
~0.2 mg/kg/dose twice daily in patients between 6-12 months 0.3 mg/kg/dose twice daily in patients between 1-3 years and 3-18 years with a weight < 40 kg 15 mg/day in patients between 3-18 years, weight > 40 kg"
15805441|NCT04405791|Procedure|Active stimulation group Sham stimluation group|"Participants are randomly assigned to either treatment group or sham group for application of transcranial low intensity focused ultrasound stimulation. For sham group, transducer is surrounded by rubber band in order to block the transmission of ultrasonic wave.
~Before initiating transcranial low intensity focused ultrasonic stimulation, in order to identify anatomical structure of the brain, Brain Magnetic Resonance Image(MRI) and Computer Tomography(CT) will be taken. For image coordination, multi-modal stick(fiducial marker, PinPoint) will be attached to the participant.
~With acquired brain images of the participant, researchers identify participant's dorsolateral prefrontal cortex(DLPFC) region, and design focused ultrasound focus targeting, image-guidance method.
~The treatment is started by targeting left DLPFC region according to assigned groups. Both the treatment and sham group will be under procedure for 2 weeks, 3 times a week."
15805442|NCT04405778|Biological|TAK-102|TAK-102 intravenous infusion
15805443|NCT04405765|Device|NPWT and lyopreserved Stravix|Subjects will be treated with NPWT and lyopreserved Stravix
15805452|NCT04405700|Other|Pharmacovigilance surveillance program|The pharmacovigilance (PV) surveillance program will prospectively monitor for adverse pregnancy and infant outcomes, including the presence of congenital abnormalities, among HIV-positive and HIV-negative women and their infants at clinical sites affiliated with the International Epidemiology Databases to Evaluate consortium (IeDEA).
15805453|NCT04405687|Procedure|Severe head and face deformity reconstructive surgery|Three questionnaires, including the 36-Item Short Form Health Survey questionnaire (SF-36), Aesthetic and Functional Status Score of Facial Soft-Tissue Deformities/Defects (A&F) and Euroqol 5 dimensions 5 levels questionnaire (EQ-5D-5L), were conducted to evaluate their quality of life and satisfaction with facial aesthetic and functional status.
15805454|NCT04405674|Drug|Tislelizumab|Tislelizumab 200mg administered intravenously (IV) on Day 1 of each 21-day cycle
15805455|NCT04405674|Drug|Carboplatin and Nab-paclitaxel|Carboplatin AUC 5 and Nab-paclitaxel 260mg/m2 administered intravenously (IV) on Day 1 of each 21-day cycle, 4 cycles
15805456|NCT04405674|Drug|Pemetrexed|Pemetrexed 500mg/m2 administered intravenously (IV) on Day 1 of each 21-day cycle
15805457|NCT04405648|Behavioral|CVS GROUP|the students will respond to CVS-F3 questionnaire to report their potential CVS complains and associated screen factors as screen-time, screen-size, screen-resolution and other factors.
15805458|NCT04405635|Other|No intervention or exposure|No intervention or exposure
15805459|NCT04405622|Drug|Toripalimab plus gemcitabine|Subjects receive gemcitabine 1000mg/m2 (Day 1 and Day 8) and Toripalimab , 240mg, (Day 1) of each 21 days for at most 6 cycles, followed by Toripalimab 240mg every three weeks (Q3W) maintenance. Treatment was continued until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or investigator decision.
15805460|NCT04405609|Device|ArmAssist|"The usability study protocol include 3 ArmAssist systems (2 designed for the left hand and one for the right hand) that could not be used in parallel because the aim of the study was to bring the systems to the home environment during part of the evaluation.
~The usability study is carried out in two phases:
~First phase: 5 weeks.
~Second phase: 3 weeks. Each phase included a week of training at the Hospital or IMIBIC facilities with a physiotherapist, and then 2 weeks at the patient's home, being the first one with the physiotherapist supervision and the second one by their own with the possibility of physiotherapist remote support."
15805461|NCT04405596|Drug|Ambroxol Hydrochloride|The treatment regimen consists of a titration phase and a maintenance phase. Participants begin the titration phase (Weeks 1 and 2) taking 6 capsules a day (450mg or 0 mg) divided BID (3 capsules in the morning and 3 capsules in the evening). The first medication dose will be taken at the end of Baseline visit and in the presence of the study Neurologist. Possible side effects will be observed for 30 minutes. Medication dose will increase bi-weekly to 12 capsules on Weeks 3 and 4, and 18 capsules on Weeks 5 and 6 divided BID. At the end of titration (Week 5) participants will have reached a maximum of 1350mg or 0mg per day, depending on group allocation. In the maintenance phase, participants will remain in their maximum dose (1350mg or 0mg) from Week 5 to Week 52 (End of Trial).
15805462|NCT04405596|Other|Placebo|The treatment regimen consists of a titration phase and a maintenance phase. Participants begin the titration phase (Weeks 1 and 2) taking 6 capsules a day (450mg or 0 mg) divided BID (3 capsules in the morning and 3 capsules in the evening). The first medication dose will be taken at the end of Baseline visit and in the presence of the study Neurologist. Possible side effects will be observed for 30 minutes. Medication dose will increase bi-weekly to 12 capsules on Weeks 3 and 4, and 18 capsules on Weeks 5 and 6 divided BID. At the end of titration (Week 5) participants will have reached a maximum of 1350mg or 0mg per day, depending on group allocation. In the maintenance phase, participants will remain in their maximum dose (1350mg or 0mg) from Week 5 to Week 52 (End of Trial).
15805463|NCT04405583|Device|Occlutech Atrial Flow Regulator|The Occlutech Atrial Flow Regulator is an interatrial shunt device for transcatheter delivery.
15805464|NCT04405570|Drug|EIDD-2801|Oral capsule of EIDD-2801
15805465|NCT04405570|Drug|Placebo (PBO)|Placebo oral capsule
15805466|NCT04405544|Diagnostic Test|CT-scan|chest CT-scan
15805467|NCT04405544|Diagnostic Test|EEG|Electroencephalography
15805468|NCT04405544|Diagnostic Test|EP|Evoked potential
15805469|NCT04405544|Diagnostic Test|Pulse oximetry|Pulse oximetry
15805470|NCT04405544|Diagnostic Test|Blood tests|Blood tests
15805471|NCT04405531|Other|task-oriented training (TOT)|The study group received a TOT together with a conventional occupational therapy (COT). The study groups received a treatment for 20 sessions at a hospital setting.
15805472|NCT04405531|Other|conventional occupational therapy (COT)|The control group received only a COT program. The control groups received a treatment for 20 sessions at a hospital setting.
15805473|NCT04405518|Drug|Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]|The drug used in this study is Riastap, 1g (Fibrinogen). The dose administered will depend on the arm group assigned and in the results of the thromboelastogram during the procedure.
15805474|NCT04405505|Drug|TQB2450|TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
15805475|NCT04405505|Drug|Anlotinib|a multi-target receptor tyrosine kinase inhibitor.
15805476|NCT04405505|Drug|Paclitaxel for Injection (albumin bound)|a anti-microtubule drug.
15805477|NCT04405492|Device|Taking blood samples (capillary and venous), saliva sampling and nasopharyngeal sampling.|"After inclusion, demographic and medical data will be collected. Evaluated point-of-care devices will be tested immediately. Blood samples (capillary and venous), salivary sample and nasopharyngeal swab will be taken. Clinical samples will be stored in a dedicated biobank. Other SARS-CoV-2 diagnostic tests will be evaluated in the laboratory on the different clinical samples retrieved from the biobank.
~For all antigenic, molecular and serological tests evaluated, the reference method will be real-time RT-PCR as well as the result of medical imaging carried out as part of patient care."
15805525|NCT04405193|Drug|N-acetyl cysteine|Eligible patients will be randomised to receive N-acetylcysteine or placebo
15805526|NCT04405193|Drug|Placebo|Matching Placebo
15805527|NCT04405180|Drug|Placebos|Oral placebo capsule at a dose of 20 mg administered three times per day, during the day.
15805528|NCT04405180|Drug|20mg sodium nitrite tid|Oral, inorganic sodium nitrite capsule at a dose of 20 mg administered three times per day, during the day.
15805529|NCT04405167|Drug|Tasquinimod|Tasquinimod will be supplied as oral capsules.
15805478|NCT04405492|Device|Taking blood samples (capillary and venous), saliva sampling and nasopharyngeal sampling.|"After inclusion, demographic and medical data will be collected. Point-of-care devices will be tested immediately. Blood samples (capillary and venous), salivary sample and nasopharyngeal swab will be taken (D0). A follow-up at D15, M1, M3, M6, M9 will be done. At each visit, participants will be asked information about their health status and their contacts with COVID-19 patients. Blood samples (capillary and venous), salivary sample and nasopharyngeal swab will be taken. Point-of-care devices will be tested during the visit.
~Cinical samples will be stored in a dedicated biobank. Other SARS-CoV-2 diagnostic tests will be evaluated in the laboratory on the different samples retrieved from the biobank.
~For all antigenic, molecular and serological tests evaluated, the reference method will be real-time RT-PCR as well as the result of medical imaging carried out as part of patient care."
15805479|NCT04405492|Device|Capillary and salivary sampling|Two rapid tests (NG Biotech) allowing anti-SRAS-CoV-2 antibodies detection from a fingerpick blood sample and antigen detection from a salivary sample will be provided in 3 pharmacies of Ile de France. The inclusion of lay persons will be carried out in pharmacies by investigators of the recruiting centers (Bacteriology and Virology departments). After inclusion, one of the tests will be given to the participant for self-testing. After performing the test, the participant will complete a questionnaire to give a feedback on the test usability and the result obtained.
15805481|NCT04405466|Procedure|Blood sampling|Blood samples
15805482|NCT04405466|Procedure|Throat swab|Throat swab
15805483|NCT04405453|Procedure|trapezius muscle injection|TMI group will receive ultrasound guided trapezius muscle injection two times with one week interval.
15805484|NCT04405453|Procedure|erector spina plane block|1th week will receive ultrasound guided trapezius muscle injection and in the 2nd week ultrasound guided erector spina plane block will receive
15805485|NCT04405440|Behavioral|Behavioral avoidance task|Behavioral task able to measure avoidance actions, US-expectancy, and reward-related indexes in different learning times
15805486|NCT04405427|Procedure|head acupoints acupuncture|The participants will undergo GV20, EX-HN-1, GV21, GV22, GV23, GV24, GV29, and GB13 head acupoints aupunture treatment 3 times/ 1 week for 4 weeks.
15805487|NCT04405427|Procedure|body acupoints acupuncture|The participants will undergo HT7, PC6, SP6, ST36, KI3, and LR3 body acupoints acupunture treatment 3 time/1 week for 4 weeks.
15805488|NCT04405414|Other|Form|Data regarding the use of CBD will be collected: the form, the route of administration, the effects sought and felt, the method of obtaining, the impact on other drugs and/or substances use and the drug liking of CBD
15805489|NCT04405401|Radiation|SABR|SABR to all oligoprogressive lesions + continuation of current systemic therapy
15805490|NCT04405401|Other|Standard of care|Patients on the standard arm will be treated as per standard of care in our institution. Treatment options could include switching to next systemic therapy line, best supportive care or continuing on current systemic therapy.
15805491|NCT04405388|Drug|Placebo|Placebo will be given orally as capsule (same size and weight as Spermidine capula)
15805492|NCT04405388|Drug|Spermidine|Spermidine will be given orally as capsule (4mg/day)
15805493|NCT04405375|Drug|gemcitabin|1.25g/㎡ d1, repeated every 21 days
15805494|NCT04405375|Drug|Pegaspargase|2500IU/㎡ d1, total dose=<3750IU, repeated every 21 days
15805495|NCT04405375|Drug|Etoposide|75mg/㎡ d1-3, repeated every 21 days
15805496|NCT04405375|Drug|Dexamethasone|20mg d1-4
15805497|NCT04405349|Biological|VB10.16|Vaccination
15805498|NCT04405349|Biological|Atezolizumab|Intravenously infusion
15805499|NCT04405336|Drug|tab block|injection of tab block to women who are doing cs
15805500|NCT04405336|Drug|PCA|giving women PCA
15805501|NCT04405336|Drug|women who will not receive tab block or PCA|no tab block or PCA will be given
15805502|NCT04405323|Drug|Lu AG06466|hard capsules, orally, single doses
15805503|NCT04405323|Drug|Itraconazole|200 and 300 mg, capsules, orally
15805504|NCT04405310|Biological|Convalescent Plasma of patients with COVID-19|Convalescent Plasma from patients with covid-19 by Apheresis, the maximum plasma volume withdrawn per session should not exceed 600 mL, excluding the anticoagulant volume, or 16% of the total blood volume, in the absence of volumetric replacement.
15805505|NCT04405310|Other|placebo (hartmann plus albumine)|use of albumin 20% in 250cc of Hartmann solution
15805507|NCT04405284|Other|use and exposure to disinfectants during the coronavirus pandemic|The use of disinfecting products in deep house cleaning by women during the coronavirus lockdown.
15805508|NCT04405271|Drug|Emtricitabine/Tenofovir Alafenamide 200 MG-25 MG Oral Tablet|Emtricitabine/Tenofovir alafenamide (FTC/TAF) in 200 mg/25 mg tablets. A dose of 1 tablet per day will be administered for a total of 12 weeks
15805509|NCT04405271|Drug|Placebo|A dose of 1 tablet per day will be administered for a total of 12 weeks.
15805510|NCT04405258|Procedure|Pulmonary vein isolation|Pulmonary vein isolation, superior vena cava isolation, and cavotricuspid isthmus ablation
15805511|NCT04405258|Procedure|Left posterior wall isolation|Pulmonary vein isolation, superior vena cava isolation, cavotricuspid isthmus ablation, and left posterior wall isolation
15805512|NCT04405245|Drug|Latanoprost ophthalmic solution|Latanoprost opthalmic solution to be dosed once daily
15805513|NCT04405245|Drug|AKB-9778|AKB-9778 opthalmic solution
15805514|NCT04405245|Drug|Placebo|placebo for AKB-9778 opthalmic solution
15805515|NCT04405232|Other|Non-interventional|Observational study
15805516|NCT04405219|Other|The Relationship Between Preoperative Smoking Cessation, Anxiety, Pain|Preoperative anxiety high score suggests stress related to surgery and anesthesia. High anxiety scores independent of post-operative pain showed smoking withdrawal.
15805517|NCT04405206|Drug|Oxaliplatin|OXA 130mg/m2
15805518|NCT04405206|Drug|Capecitabine|Cape 1000mg/m2
15805519|NCT04405206|Radiation|intensity modulated radiotherapy|IMRT 50.4Gy/22f
15805520|NCT04405206|Procedure|DRE-Endoscopy-MRI-CEA|examination process in follow up
15805530|NCT04405167|Drug|IRd chemotherapy|IRd chemotherapy with ixazomib, lenalidomide, and dexamethasone
15805531|NCT04405154|Biological|Camrelizumab|Administered as an intravenous (IV) infusion every 2 weeks (Q2W): 14 days prior to radiation, then Day 1 of radiation and then every 14 days for total 8 doses.
15805532|NCT04405154|Drug|Cisplatin|75-100 mg/m^2 administered as an IV infusion Q3W, for a total of 3 doses, at the same time as radiation: Day 1, Day 22, Day 43 of radiation.
15805533|NCT04405154|Radiation|IMRT or VMAT|66-70 Gy given in 33-35 fractions over 6-7 weeks.
15805534|NCT04405128|Diagnostic Test|Transcranial Tissue Doppler (TCTD)|"Doppler ultrasound technique called 'Brain Tissue Velocimetry (Brain TV), to investigate brain tissue motion over the cardiac cycle."
15805535|NCT04405128|Diagnostic Test|Brain MRI|Brain MRI for investigation of brain tIssue motion in the presence of acute acquired brain injury.
15805536|NCT04405115|Behavioral|Geriatric Assessment|Geriatric Assessment Visit
15805537|NCT04405102|Drug|Ozanimod|The investigational medical product (IMP) for this study is ozanimod. Ozanimod 0.23 mg be administered once daily for 4 days and then ozanimod 0.46 mg will be administered once daily for ten days.
15805538|NCT04405102|Other|Standard of care|During hospitalization, patient will be given standard of care (Recommendations for standard of care management of COVID-19 will be provided for anticoagulation, fluid resuscitation, corticoids and other immunomodulators, antipyretics agents, antiviral agents and other treatments. These recommendations are subject to modifications based on the new literature data).
15805539|NCT04405089|Device|Device: Active Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training|Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the right prefrontal cortex for total of 26 minutes.
15805540|NCT04405089|Device|Device: Sham Transcranial Direct Current Stimulation (tDCS) coupled with cognitive training|Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session).
15805541|NCT04405076|Biological|Biological: mRNA-1273|Sterile liquid for injection
15805542|NCT04405076|Biological|Placebo|0.9% sodium chloride (normal saline) injection
15805543|NCT04405076|Biological|mRNA-1273.351|Sterile liquid for injection
15805545|NCT04405050|Device|Restrata|Restrata® is a novel synthetic nanofabricated scaffold (Restrata Wound Matrix (RWM), Acera Surgical, St. Louis, Missouri) has been developed which is a sterile, single-use device intended for use in the local management of wounds. The RWM is a soft, white, conformable, non-friable, absorbable matrix that acts as a protective covering for wound defects, providing a moist environment for the body's natural healing process to occur (Figure 2). The RWM is made from synthetic biocompatible materials and was designed to include a fibrous structure with high porosity, similar to native ECM. As a viable wrap for surgical procedures, Restrata conforms to injured tissue, can be sutured, and is arthroscopic and robotic procedure friendly.
15805546|NCT04405050|Device|Negative Pressure Wound Therapy (NPWT)|Negative Pressure Wound Therapy (NPWT) has dramatically changed the care of complex foot wounds. Compared to standard wound care, patients with diabetic foot wounds that are treated with NPWT are 5.9 times more likely to heal and 4.4 times less likely to require amputation. NPWT involves the delivery of sub-atmospheric pressure through a vacuum pump connected to a specialized dressing to maintain a closed environment. NPWT increases perfusion to the wound, accelerates granulation tissue formation, reduces edema, and reduces bio-burden
15805547|NCT04405037|Drug|Alvimopan|Alvimopan will be given to patients who are diagnosed with postoperative ileus after surgery
15805548|NCT04405024|Diagnostic Test|Hepatitis C testing|Hepatitis C Screening
15805549|NCT04405011|Drug|24-week Entecavir|Entecavir 0.5mg for 24 weeks will be delivered
15805550|NCT04405011|Drug|12-week Entecavir|Entecavir for 12 weeks will be delivered and serve as the active comparator arm
15805551|NCT04404998|Other|Lower Energy Density|Test meal with lower energy density
15805552|NCT04404998|Other|Higher Energy Density|Test meal with higher energy density
15805553|NCT04404998|Other|Lower Satiation|Information on lower satiation
15805554|NCT04404998|Other|Higher Satiation|Information on higher satiation
15805555|NCT04404985|Procedure|Surgical AVF|"Surgical fistula creation is standard surgical procedures, where a small cut through the skin is made to create a channel directly between a vein and artery .
~The study procedures are standard clinical practice, and not considered an experimental procedure."
15805556|NCT04404985|Procedure|Endo-vascular AVF|Endovascular fistula creation is a minimally invasive procedure used to create a canal between close artery and vein at the forearm. A magnet attached to a catheter is passed over a guidewire into the artery while another magnet passed over the guidewire into the vein. The two magnets are aligned close to each other, then the radiofrequency electrode is released from the venous catheter and energized for 2 seconds, creating a channel between the vein and the artery.
15805557|NCT04404959|Other|fascia iliaca compartment block with ropivacaine|the fascia iliaca compartment block catheter will be placed with the use of ultrasound till the day of surgery. Bolus doses will be given every 12 hours (40 ml of ropivacaine 0.25%)
15805558|NCT04404959|Other|fascia iliaca compartment block with placebo|the fascia iliaca compartment block catheter will be placed with the use of ultrasound till the day of surgery. Bolus doses will be given every 12 hours (40 ml of normal saline)
15805559|NCT04404946|Other|phenylephrine infusion|in parturients allocated to the phenylephrine group, a phenylephrine infusion will be started as soon as spinal anesthesia is initiated
15805560|NCT04404946|Other|norepinephrine infusion|in parturients allocated to the norepinephrine group, a norepinephrine infusion will be started as soon as spinal anesthesia is initiated
15805561|NCT04404946|Other|placebo infusion|in parturients allocated to the placebo group, a normal saline infusion will be started as soon as spinal anesthesia is initiated
15805562|NCT04404933|Other|Treatment algorithm for OIC|Treatment Algorithm for OIC
15805563|NCT04404920|Other|Questionnaire|"Novel questionnaire about oral symptoms (Oral symptom assessment scale / OSAS), and validated questionnaire about physical and psychological symptoms (Memorial Symptom Assessment Scale / MSAS)."
15805564|NCT04404907|Other|no intervention|This is a secondary analysis of registry data.
15805692|NCT04403841|Other|Usual diabetes care alone|Usual diabetes care was consistent with the ADA guidelines (15) and comprised standard dietary and exercise advice in addition to antidiabetes treatment
15805565|NCT04404881|Drug|Bevacizumab|"Induction Period (first 3 months of bevacizumab treatment):
~-- Bevacizumab: once every 2 weeks via intravenous infusion for up to 12 weeks.
~Maintenance Period (second 3 months of bevacizumab treatment):
~Bevacizumab: once every 4 weeks via intravenous infusion for up to 12 weeks."
15805566|NCT04404868|Other|Normal clinical practice|There are no experimental interventions. The procedures are in line with normal clinical practice.
15805567|NCT04404855|Other|NGS + Antibiotic Recommendation|NGS results in addition to recommended antibiotic therapy made by infectious disease pharmacist
15805568|NCT04404855|Procedure|Standard of Care treatment|Subjects will have a standard of care urine culture and prophylactic antibiotic prescribed per routine care.
15805569|NCT04404829|Other|Manual Therapy|"The first level of IMT was treated in this study: the objective is to harmonize the cranio-sacral and sacro-pelvic systems, as this is fundamental for maintaining good posture. The first therapeutic maneuvers should be focused on releasing of the sacrum and the pelvis. The first is considered a key area for the correct transmission of forces and loads from the lower limbs to the upper limbs and vice versa and shares the role of rigid elements for this purpose (bones) and tensile elements (muscles, ligaments, fascia) in the whole body. In this level. Compensatory injuries that the body has started after a primary injury are treated on this level, through the Fluidic Chains. The diagnosis of this level is performed by cranial somotopias. Practically all the treatment is carried out on the sacrum. The first step are the fuses, which are vibration zones which act as a protection system for the body. These points sometimes stop working, which interrupts the correct movement of the PRM."
15805570|NCT04404816|Drug|heliox|NIV-NAVA with a conventional gas mixture (air-oxygen) at baseline, 3 hours of NIV-NAVA with heliox and return to NIV-NAVA with air-oxygen.
15805571|NCT04404803|Other|questionnaire|Patients will be asked to complete a questionnaire about the reasons why they agree / decline to take part in research.
15805572|NCT04404790|Drug|Anfibatide 5 IU/60kg|5 IU/60kg IV administration of Anfibatide with 5 minutes
15805573|NCT04404790|Drug|Anfibatide 5 IU/60kg +0.002 IU/kg/h|5 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.002 IU/kg/h continuous intravenous infusion with 48 hours
15805574|NCT04404790|Drug|Anfibatide 5 IU/60kg +0.004 IU/kg/h|5 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.004 IU/kg/h continuous intravenous infusion with 48 hours
15805575|NCT04404790|Drug|Anfibatide 5 IU/60kg +0.008 IU/kg/h|5 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.008 IU/kg/h continuous intravenous infusion with 48 hours
15805576|NCT04404790|Drug|Anfibatide 7 IU/60kg|7 IU/60kg IV administration of Anfibatide with 5 minutes
15805577|NCT04404790|Drug|Anfibatide 7 IU/60kg +0.002 IU/kg/h|7 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.002 IU/kg/h continuous intravenous infusion with 48 hours
15805578|NCT04404790|Drug|Anfibatide 7 IU/60kg +0.004 IU/kg/h|7 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.004 IU/kg/h continuous intravenous infusion with 48 hours
15805579|NCT04404790|Drug|Anfibatide 7 IU/60kg +0.008 IU/kg/h|7 IU/60kg IV administration of Anfibatide with 5 minutes follow by the dose of 0.008 IU/kg/h continuous intravenous infusion with 48 hours
15805580|NCT04404777|Procedure|Treatment for local recurrence with surgery or other treatments|All types of treatment for local recurrence will be evaluated
15805581|NCT04404764|Drug|Nusinersen Injectable Product|The patient´s treatment is provided by SUS. The following dosage scheme of nurinersen is the one approved by ANVISA (Brazilian National Health Surveillance Agency): Nusinersen, 12 mg (5 mL) on days 0 (zero), 14 and 28. A fourth dose will be on day 63 with a maintenance dose once every 4 (four) months. The study will NOT have direct influence on the care received by patients. Data on adherence, interventions, hospitalizations, mechanical ventilation, procedures and adverse events will be obtained from the patients´ medical records.
15805582|NCT04404751|Combination Product|Iodised salt with Iron, Folic acid and Vitamin B12|Fortified salt with either Iron and Iodine only or Fortified salt with Iodine, iron, Folic acid and Vitamin B12 compared with standard Iodized salt
15805583|NCT04404738|Procedure|MicroPort® robot-assisted laparoscopic surgery|In this group, patients undergoing robot-assisted laparoscopic surgery in urology will be performed by Microport® Surgical System
15805584|NCT04404738|Procedure|da Vinci robot-assisted laparoscopic surgery|In this group, patients undergoing robot-assisted laparoscopic surgery in urology will be performed by da Vinci Surgical System
15805585|NCT04404725|Device|comfilcon A|Subjects will be randomized to wear comfilcon A for one month.
15805586|NCT04404725|Device|Samfilcon A|Subjects will be randomized to wear samfilcon A for one month.
15805587|NCT04404712|Drug|[11C]MK-3168|One PET scan involving administration of PET ligand [11C]MK-3168
15805588|NCT04404699|Diagnostic Test|Stimulation TcPO2 test|"During measurement of TcPO2 in various angiosomes the stimulation test will be performed. We modify the Ratschow test (elevation of the lower limbs, rhythmic flexion and extension in talocrural joints for 2 minutes, then return to horizontal position). TcPO2 is measured continuously. Depending on the type of detected flows by DUS in the evaluated arteries supplying the relevant angiosome, in which TcPO2 values are measured, the patients and their angiosomes will be divided into 2 baseline groups - group M with monophasic flows or arterial obliterations and group T with triphasic flows.
~We will compare macrocirculation parameters-systolic pressure on dorsalis pedis artery (DPA), posterior tibial artery (PTA) and their doppler indexes. The resting TcPO2, the minimal TcPO2 found during the stimulation test, their delta (resting TcPO2 - minimal TcPO2) and the percentage decrease in TcPO2 will be compared between the study groups, as well as the duration of TcPO2 recovery."
15805589|NCT04404686|Drug|Indomethacin|Per vagina administration of 100 mg followed by a second 100 mg dosage the following day
15805590|NCT04404686|Drug|Nifedipine|Per os administration according to current protocol of 20mg each 20 minutes for 1 hour followed by 20 mg q8 for 48 hours.
15805591|NCT04404673|Procedure|Evaluation of urinary and sexual dysfunction after rectal resection|Comparison among the 4 different surgical approaches for urinary and sexual function
15805592|NCT04404660|Biological|AUTO1|Following pre-conditioning with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with a total target dose of 410E+6 of CD19-positive CAR T cells as a split dose on Day 1 and on Day 10 (±2 days).
15805693|NCT04403828|Other|Survey|a cross-sectional, online survey-based study administered to Dentist in Egypt. A 20-item questionnaire developed and distributed using Google Forms.
15805593|NCT04404647|Procedure|Irreversible electroporation|The IRE procedure will be carried out as ultrasound guided technique either percutaneously or during laparotomy. Needle spacing and electrical pulse delivery will be performed in a standardized way.
15805594|NCT04404621|Behavioral|Physical exercise (PE) training and computer-based brain (CBB)|18 weeks of PE and CBB.
15805595|NCT04404608|Diagnostic Test|Complete blood picture, bone marrow aspiration cytology|none except the regular routine investigations in such cases
15805596|NCT04404595|Biological|CT041|treatment with anti-claudin18.2 chimeric antigen receptor T-cell infusion
15805597|NCT04404569|Drug|BXQ-350|BXQ-350 is a novel anti-neoplastic therapeutic agent configured from two components: Saposin C (SapC), an expressed (human) lysosomal protein, and the phospholipid dioleoylphosphatidyl-serine (DOPS), a phospholipid located on cell membranes (clinical formulation BXQ-350). BXQ-350 is administered by intravenous (IV) infusion in 28-day cycles
15805598|NCT04404556|Behavioral|Diabetes Journey|Web-based telehealth intervention focused on adherence barriers and problem-solving
15805599|NCT04404556|Behavioral|Enhanced Standard of Care|General education via the T1DToolkit website, as well as 4 phone calls with certified diabetes educators (CDEs) will be provided.
15805600|NCT04404543|Drug|SYHA1807|Escalation Cohort Administration: Orally
15805601|NCT04404543|Drug|SYHA1807|Dose Expansion Cohort Administration: Orally
15805602|NCT04404530|Drug|Palynziq|Participants will take Palynziq as prescribed by their genetics doctor. In accordance with the Palynziq Risk Evaluation and Mitigation Strategy (REMS) protocol, patients will have their first injection of Palynziq at the Emory Genetics Clinic under the supervision of a physician. After initiating therapy, patients will continue to mail in blood spot filter papers and 3-day dietary records to their clinic providers as standard components of clinical care.
15805603|NCT04404517|Drug|Adalimumab|Monoclonal antibody used in IBD treatment
15805604|NCT04404491|Drug|Procedural death 1|200mg,d1,15,29,43,57,I.V
15805605|NCT04404491|Drug|Capecitabine|Capecitabine: 625mg/m2, bid d1-5; q1w, po,6 weeks in total.
15805606|NCT04404491|Radiation|Radiotherapy|radiotherapy： 50-50.4Gy ，1.8-2 Gy/d，5d/w.
15805607|NCT04404491|Drug|Placebo|placebo: 200mg,d1,15,29,43,57,I.V
15805608|NCT04404478|Behavioral|B-SWELL: Midlife Black Women's Stress Reduction Wellness Program|Stress reduction and culturally tailored information on healthy lifestyle behaviors will be used to increase healthy lifestyle behaviors according to the AHA's Life's Simple 7. Focus of intervention on per support, goal setting, stress reduction, and culturally relevant information.
15805609|NCT04404478|Behavioral|WE: Wellness program for Midlife Black Women|Culturally tailored information will be provided about healthy lifestyle behaviors will be used to increase healthy lifestyle behaviors according to the AHA's Life's Simple 7. Focus of intervention on peer support and culturally relevant content.
15805610|NCT04404452|Device|Use of Eko CORE and Eko DUO electronic stethoscopes|Auscultation of heart and lung sounds using electronic stethoscopes
15805611|NCT04404439|Drug|Nortriptyline + topiramate|Treatment group 1
15805612|NCT04404439|Drug|Verapamil + paroxetine|Treatment group 2
15805613|NCT04404439|Other|Placebo|Placebo comparator
15805614|NCT04404426|Dietary Supplement|L-citrulline|Administration of citrulline enterally for 7 days.
15805615|NCT04404426|Other|Placebo|Administration of placebo (water) enterally for 7 days
15805616|NCT04404413|Behavioral|Intensity interval training (HIIT)|2x8 weeks of high-intensity interval training (HIIT)
15805617|NCT04404413|Behavioral|Intensity interval training (HIIT) + intermittent fasting|2x8 high-intensity interval training with (HIIT+IF) intermittent fasting caloric restriction (20% reduction in weekly energy intake).
15805620|NCT04404387|Drug|Administration of vitamin C|"The intervention is intravenous vitamin C administered in bolus doses of 50 mg/kg mixed in a 50-mL solution of either dextrose 5% in water (D5W) or normal saline (0.9% NaCl), during 30 to 60 minutes or more for participants over 120 kg not to exceed 100 mg/minute, every 6 hours for 96 hours (i.e. 200 mg/kg/day and 16 doses in total).
~The other name of the drug: Ascorbic acid."
15805621|NCT04404387|Drug|Administration of placebo|Administration of placebo. Patients (in the control arm) will receive dextrose 5% in water (D5W) or normal saline (0.9% NaCl) in a volume to match the vitamin C. Placebo will be infused over 30 to 60 minutes or more for participants over 120 kg not to exceed 100 mg/minute as per the infusion instructions of vitamin C.
15805622|NCT04404374|Procedure|A-PRF/EMD|Comparing healing effect of an autologous and a xenogenic product
15805623|NCT04404361|Drug|Pacritinib|100 mg capsules
15805624|NCT04404361|Drug|Placebo|Placebo capsules matching pacritinib 100 mg capsules
15805625|NCT04404348|Behavioral|Cognitive Training|Exercises used will be: Mind Bender, Divided Attention, Freeze Frame, Mixed Signals, Target Tracker, To Do List.
15805626|NCT04404348|Behavioral|Placebo Control|Games are drawn from the set of research control games provided by Posit Science-Brain HQ.
15805627|NCT04404335|Diagnostic Test|Crevicular fluid analysis by using ELISA testing.|Samples of crevicular fluid (fluid existing in the space between the gums and the roots of the teeth) will be obtained from healthy and periodontal patients. In periodontal patients, samples will be taken before and after receiving a routine course of periodontal treatment (root scale and polish) to assess the levels of a peptide called LL-37. Samples will then be analysed using laboratory procedures (ELISA)
15805658|NCT04404114|Diagnostic Test|Shear wave elastography to distinguish CKD from normal kidney|Record the patient's kidney size, cortical thickness, possible lesion by ordinary renal sonography as well as cortical elasticity by shear wave elastography
15805691|NCT04403841|Other|patient education and self-management intervention in a low-resource setting on diabetes knowledge and levels of blood glucose control|The intervention consisted group education on type 2 diabetes, including, in addition to usual diabetes care: information on diet, exercise, drug therapy, and adherence
15805628|NCT04404322|Other|IPT A Suicide Crisis Intervention|The intervention is comprised of five weekly sessions followed by monthly emails to the patients and their parents over a period of three months. The first session is aimed at introducing the intervention, assessing depression and suicidal risk and building a safety plan. The safety plan consists of a prioritized list of coping strategies that the patient can use when suicidal risk is increased. The second session is focused on reviewing the patient's interpersonal relationships (using the closeness circle and interpersonal inventory) and conceptualizing the interpersonal problem area. Sessions 3-4 focus on developing and practicing interpersonal, emotional and behavioral coping strategies relevant for suicidal risk. Lastly, in session 5, patient and therapist go over the process and main issues which were worked on, emphasizing relapse prevention by going back to the safety plan. First and fifth sessions always involve the parents.
15805629|NCT04404322|Other|Treatment As Usual|patients receive an integrative combination of psychodynamic, supportive and cognitive behavioral therapy, usually lasting between 10-30 weeks
15805630|NCT04404296|Device|25-gauge, bevel-tip, 20000 cut per minute pars plana vitrectomy|Pars plana vitrectomy using 25-gauge, bevel-tip, 20000 cut per minute vitrectomy probe
15805635|NCT04404270|Diagnostic Test|Anti-SARS-CoV2 Serology|The anti-SARS-CoV2 serological status will be measured on a blood sample collected at Day 0.
15805636|NCT04404270|Behavioral|Questionnaire|"Epidemiological data will be collected in a questionnaire that will be filled by participants at Day 0 (Visit 1), after 3 months (Visit 2) and after 9 months (Visit 3).
~The questionnaire includes:
~medical data (height, weight, smoking, history of intense stress);
~socio-demographic data (age, gender, civil/military status, function/occupation, rank category, army, family status/home composition, housing conditions, etc.);
~clinical data : history of symptoms suggestive of COVID-19 in the last 3 months, current symptoms suggestive of COVID-19;
~use of care, hospitalization, work stoppage in the last 3 months;
~contact with people who are symptomatic or proven COVID-19."
15805637|NCT04404270|Diagnostic Test|Anti-SARS-CoV2 serological controls and serum neutralization|Serological controls and a serum neutralization test will be performed on blood samples collected 3 months (Visit 2) and 9 months (Visit 3) after Day 0, respectively.
15805638|NCT04404257|Radiation|ControlRad System|Cardiac Catheterization or electrophysiology implant procedures with Control Rad system device installed in the cath lab room #5.
15805639|NCT04404257|Radiation|Without ControlRad System|Cardiac Catheterization or electrophysiology implant procedures in cath lab room 5 without the ControlRad system device.
15805640|NCT04404231|Radiation|Delivery of infrared light to the head|Building upon the experience gathered from previous depression clinical trials, we will treat twice weekly for a total of 4-week duration consisting of 8 sessions. Each treatment will last 20 min and areas irradiated will include frontal and temporal areas bilaterally. Irradiance of 250 mW/cm2 with a fluence of 60 J/cm2.
15805641|NCT04404231|Other|No Infrared treatment|This is sham treatment. No light is actually given.
15805642|NCT04404218|Dietary Supplement|Açaí palm berry extract - natural product|Patients will be prescribed to take 1 capsule (520mg) of Açaí Palm Berry every 8 hours for a total of 3 capsules a day, during 30 days. Total dose: 1,560mg/day of Açaí Berry extract.
15805643|NCT04404218|Other|Placebo|Patients will take 1 placebo pill every 8 hours (total of 3 capsules a day) for 30 days.
15805644|NCT04404205|Diagnostic Test|Postural stability measurements by Biodex Balance System|Postural stability measurements will be done by Biodex Balance System. Three preprogrammed main tests will be applied. Postural stability, fall index, sensory integration will be calculated. All tests will be done in four conditions; implant off(1), implant on(2), implant on music on(3), and implant off again(4).
15805647|NCT04404179|Other|COVID-19 FACILITY|A COVID-19 facility was setup within the Prison. All positive prisoners were managed in the facility. If further intervention was required they were to be shifted to Services Hospital , Lahore.
15805648|NCT04404166|Behavioral|PINGS 2|Home BP monitoring, medication reminders using phone alerts, and patient education on hypertension, cardiovascular risk reduction & stroke
15805649|NCT04404153|Device|tDCS device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver active tDCS.|At-home remotely supervised tDCS delivered over the dorsolateral prefrontal cortex with the anode on the left, cathode on the right, at an intensity of 2 mA, delivered for 30 minutes five times per week (Monday-Friday) for 26 weeks (6 months).
15805650|NCT04404153|Device|tDCS device model Soterix mini-CT (Soterix Medical Inc., New York, NY) programed to deliver sham tDCS.|Sham treatment will consist of the current ramped up to 2mA over 30 seconds, ramped down over 30 seconds and stay at 0 current for the remaining time of the 30-minute application period five times per week (Monday-Friday) for 26 weeks (6 months).
15805651|NCT04404140|Drug|Ipatasertib|Ipatasertib will be administered at a dose of 400 mg, as per the dosing schedule described above.
15805652|NCT04404140|Drug|Atezolizumab|Atezolizumab will be administered at a fixed dose of 1200 mg, as per the dosing schedule described above.
15805653|NCT04404140|Drug|Docetaxel|Docetaxel will be administered at a dose of 75 mg/m^2, as per the dosing schedule described above.
15805654|NCT04404127|Drug|Basiliximab 20 milligram [Simulect]|Basiliximab
15805655|NCT04404127|Other|Normal Saline|No-Induction
15805656|NCT04404114|Diagnostic Test|Shear wave elastography to distinguish AKI from normal kidney|Record the patient's kidney size, cortical thickness, possible lesion by ordinary renal sonography as well as cortical elasticity by shear wave elastography
15805657|NCT04404114|Diagnostic Test|Shear wave elastography to distinguish AKI from CKD|Record the patient's kidney size, cortical thickness, possible lesion by ordinary renal sonography as well as cortical elasticity by shear wave elastography
15805690|NCT04403854|Procedure|Spinal Tap|together with CSF pressure estimate
15805659|NCT04404101|Procedure|1). EUS-FNA plus MFB|The cyst will be punctured using a 19-G EUS-FNA needle with a stylet. A transgastric approach will be used for PCLs located in body/tail region, and a transduodenal approach for PCLs in the head/neck region, or as determined by the endoscopist. The stylet will be removed and the wall of the cyst biopsied using the micro forceps passed through the 19 G needle under direct EUS visualization. A minimum of 4 cyst wall biopsies will be obtained to procure at least 4 visible tissue fragments. Cyst fluid will be aspirated and sent for CEA and cytology.
15805660|NCT04404101|Procedure|2). EUS-FNA Alone|The cyst will be punctured using an EUS-FNA needle with a stylet. A transgastric approach will be used for PCLs located in body/tail region, and a transduodenal approach for PCLs in the head/neck region, or as determined by the endoscopist. The stylet will be removed, and cyst fluid will be aspirated and sent for CEA, and cytology.
15805661|NCT04404088|Drug|Acalabrutinib|Given PO
15805662|NCT04404088|Drug|Lenalidomide|Given PO
15805663|NCT04404088|Biological|Rituximab|Given IV
15805664|NCT04404075|Other|SkinTracker Mobile App|a research-oriented eczema app to longitudinally track atopic dermatitis severity, symptoms, quality of life, physical activity, medication usage, and adverse events in a real-world setting
15805665|NCT04404062|Diagnostic Test|Membrane-based immunoassay kit|The kit is a qualitative membrane-based immunoassay to detect IgG and IgM antibodies to SARS-CoV-2 in whole blood, serum or plasma specimens. IgG and IgM detection components are separate allowing for differential detection of each antibody.
15805666|NCT04404062|Diagnostic Test|Quantitative antibody Tests|Antibody titres will be measured from whole blood samples taken from volunteers.
15805667|NCT04404062|Diagnostic Test|PCR Test|PCR tests will be conducted on throat swabs taken from volunteers.
15805668|NCT04404049|Biological|UB-421(25 mg/kg) Q2W|Monoclonal antibody by IV infusion plus standard ART
15805669|NCT04404049|Biological|UB-421(25 mg/kg) Q4W|Monoclonal antibody by IV infusion plus standard ART
15805670|NCT04404036|Device|SinuSonic Device|A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion.
15805671|NCT04404023|Biological|UB-221|UB-221 (75 mg/ml)
15805672|NCT04404010|Other|Immersive Virtual Reality|Participants randomized to the iVR simulator utilizes a head-mounted display producing 3D visuals with haptic controllers for an immersive operating room experience. The module produced consists of the key steps in performing a reverse shoulder arthroplasty using virtual versions of the equipment used in the real procedure. Prior to initiation, participants will be provided with a safety and training demonstration on the use of the VR module by study personnel. Participants will be provided as much time as they require to watch the video, including repetition if desired, which they will be timed for completion.
15805673|NCT04404010|Other|Surgical Technical Instructional Video|Participants will be provided as much time as they require to watch the instructional video, including repetition if desired, which they will be timed for completion.
15805674|NCT04403997|Procedure|Chromoendoscopy|Chromoendoscopy is an endoscopic technique used in the follow-up of inflammatory bowel disease of long evolution. Chromoendoscopy, through the application of specific dyes used directly on the intestinal mucosa, promotes the visualization of mucosal lesions.
15805675|NCT04403971|Drug|0.12% Chlorhexidine Oral Liquid Product|The intervention group 1 received 10ml 0.12% chlorhexidine solution for oral rinse twice a day.
15805676|NCT04403971|Drug|Listerine Oral Liquid Product|The intervention group 2 received 10ml Listerine solution for oral rinse twice a day.
15805677|NCT04403971|Other|Normal Saline Product|The control group received 10ml normal saline for oral rinse twice a day.
15805678|NCT04403958|Procedure|PRC|Total wrist arthrodesis with dorsal plate using proximal row of the wrist as bone graft
15805679|NCT04403958|Procedure|TWA|Total wrist arthrodesis with dorsal plate using iliac crest as bone graft
15805680|NCT04403945|Device|Sidestream dark field(SDF) imagining|SDF imaging consists of a hand-held device that illuminates a region by surrounding a central light guide with concentrically placed light emitting diodes,which thus provide SDF illumination.
15805681|NCT04403919|Device|Conventional Closure: Knee|Traditional closure will consist of arthrotomy (deep layer) closed with figure of eight number 1 vicryl plus followed by closure of the intermediate layer with 0 Vicryl plus. The intermediate layer will be performed at surgeon's discretion especially in thin patients. Subdermal layer with 2-0 vicryl suture followed by subcuticular 3-0 monofilament suture (monocryl PLUS, Ethicon; Johnson & Johnson) and Dermabond advanced.
15805682|NCT04403919|Device|Barbed suture closure: Knee|The barbed suture closure will consist of number 2 Stratafix symmetric PDS PLUS for the arthrotomy, intermediate layer will be performed at surgeon's discretion in thin patients, if performed will entail stratafix spiral, subdermal 2-0 stratafix spiral monocryl plus. Followed by subcuticular 3-0 stratafix spiral monocryl plus suture and Dermabond advance.
15805683|NCT04403919|Device|Conventional Closure: Hip|"The capsule will be closed with Vicryl Plus number 1
~Deep fascia with figure of eight interrupted number 1 braided absorbable suture (Vicryl plus, Ethicon; Johnson &Johnson, Somerville, NJ)
~Subdermal fat layer simple interrupted knots using number 2-0 braided absorbable sutures (Vicryl plus)
~Subcuticular 3-0 monofilament suture (monocryl plus , Ethicon; Johnson & Johnson)
~followed by the use of skin adhesive (Dermabond Advanced, Ethicon; Johnson &Johnson)."
15805684|NCT04403919|Device|Barbed suture closure: Hip|"The capsule will be closed with stratafix symmetric PDS Plus
~Deep fascia will be closed with Stratafix Symmetric PDS Plus (Stratafix symmetric PDS plus, Ethicon; Johnson &Johnson, Somerville, NJ)
~Subdermal layer with running number 2-0 barbed suture (stratafix spiral monocryl plus, Ethicon; Johnson & Johnson, Somerville, NJ)
~Subcuticular suture with stratafix spiral monocryl plus, Ethicon
~followed by the use of skin adhesive (Dermabond advanced, Ethicon; Johnson &Johnson)."
15805685|NCT04403906|Diagnostic Test|PCL COV05 - COVID 19 Ag Rapid FIA test (Rapid Antigen Test)|The PCL COV05 - COVID 19 Ag Rapid FIA test has FSC and CE approvals for the qualitative detection of SARS-CoV-2 Antigens from human oropharyngeal swabs and deep sputum samples. The manufacturer is PCL Corporation Ltd 17F, 128 B-dong, Courthouse-ro, Songpa-gu, Seoul, South Korea.
15805686|NCT04403893|Other|HANARO biliary stent placement|HANARO biliary stent placement
15805687|NCT04403880|Other|Sample collection|"Optional nasal specimen(s)
~Blood collection"
15805688|NCT04403867|Procedure|Sentinel lymph node (SLN) biosy +/- lymphadenectomy|Evaluation of type and volume of lymph nodal disease
15805689|NCT04403854|Diagnostic Test|MRI|If possible with spectroscopy
15805694|NCT04403815|Procedure|vascular access for coronary procedures|comparison of x-rays exposition of interventional cardiologist according to vascular access used
15805695|NCT04403802|Device|Voxx Human Performance Technology Socks|"Voxx Human Performance Technology Socks are commercially-available socks that are drug and electrical free. The Voxx Human Performance Technology proprietary pattern is woven into a sock that is made of 70% cotton, 25% polyester, 3% spandex, and 2% nylon.
~Prior to the 2-week treatment window, patients will be provided with 6 pairs of Voxx Human Performance Technology socks. Patients will be asked to wear the socks continuously during both waking and sleeping hours, except when showering, bathing, or swimming."
15805696|NCT04403802|Device|Placebo Socks|"Placebo socks are identical to the Voxx Human Performance Technology socks but do not include the Voxx Human Performance Technology pattern woven into the sock. Placebo socks are made of the same fabric as Voxx Human Performance Technology socks and are drug and electrical free.
~Prior to the 2-week treatment window, patients will be provided with 6 pairs of placebo socks. Patients will be asked to wear the socks continuously during both waking and sleeping hours, except when showering, bathing, or swimming."
15805697|NCT04403789|Other|Exercise Time|Employees will be provided with exercise time of 2 hours per week. The 2 hours should be used in two days. The intervention duration is 12 weeks.
15805698|NCT04403789|Behavioral|Supervised Group Exercise|The intervention group will receive 2-hours of exercise sessions per week under the supervision of a certified trainer in the gym workplace. The intervention duration is 12 weeks.
15805699|NCT04403776|Drug|tofacitinib MR 11 mg|Single oral dose of tofacitinib MR 11 mg, administered as 1 x MR 11 mg tablet, in a fasting state on Day 1 followed by once daily dosing (QD) on Days 3, 4, 5, 6 and 7.
15805700|NCT04403776|Drug|tofacitinib IR 5 mg|Two separate oral doses (12 hours apart) of tofacitinib IR 5 mg, administered one in the morning in a fasting state and one in the evening at least 2 hours after dinner on Day 1 followed by 5 mg IR every 12 hours on Days 3, 4, 5, 6 and 7.
15805701|NCT04403763|Drug|AGN-241622|Topical eye drop
15805702|NCT04403763|Drug|AGN-190584|Topical eye drop
15805703|NCT04403763|Drug|Vehicle|Topical eye drop
15805704|NCT04403750|Procedure|Combined laser-surgical technology of RRD treatment|"Nd-YAG laser excision of the vitreoretinal traction zone
~Pneumatic retinopexy (10% C3F8)
~barrier laser photocoagulation around retinal break after retinal attachment (2-3 days after pneumatic retinopexy)"
15805705|NCT04403737|Device|Rothman Index|The Rothman Index score will be calculated and visible to providers. Providers will be encouraged to follow a set of recommended-use protocols in response to different levels of the RI threshold.
15805706|NCT04403724|Drug|Bupivacaine-fentanyl-Morphine.|2.4 ml Bupivacaine 0.5%, 20 µg Fentanyl and, 100 µg preservative free morphine
15805707|NCT04403711|Other|local anesthetic and dexmedetomidine|in patients allocated to the dexmedetomidine group, ultrasound-guided transversus abdominis plane block will be performed with the combination of local anesthetic and dexmedetomidine
15805708|NCT04403711|Other|local anesthetic and placebo|in patients allocated to the dexmedetomidine group, ultrasound-guided transversus abdominis plane block will be performed with the combination of local anesthetic and normal saline
15805709|NCT04403698|Drug|Alendronate Effervescent Oral Tablet|At the earliest three months but no later than four months after the last denosumab injection, subjects will be randomized to effervescent alendronate administered for either 24 or 48 weeks
15805710|NCT04403685|Drug|Tocilizumab|Single-dose infusion of 8 mg/kg. Maximum dose of 800 mg.
15805711|NCT04403672|Device|performance evaluation study of RealDetect RT-PCR Kit for COVID-19 detection|"IEDCR uses many different kits for COVID-19 detection. These kits include, (1) A*Star Fortitute Kit 2 for COVID-19 detection (Singapure), (2) Sansure Biotec Limited (China), (3) ModularDx Kit (TIB Molecular Biology, Germany, and (4) DaAn Kit (China). Among these 2 kits, A*Star Fortitude Kit 2 has been known as the best kit in IEDCR depending on its performance because it rarely generates false positive or false negative results.
~A*Star Fortitude Kit 2 is used for confirmation of any discordant results for other kits in IEDCR. That is, IEDCR uses A*Star Fortitude Kit for COVID detection as the Gold Standard. In our case, this is the main reason for the selection of this kit in order to compare the performances of RealDetect™ COVID-19 RT-PCR kit."
15805712|NCT04403659|Device|Telemedicine/telemonitoring (TM) suite|"The couples patient/caregiver will receive and trained to use a suite of TM instruments including: sphygmomanometer, pulse oximeter, weight scale, thermometer, glucometer, electrocardiograph. During the intervention phase (i.e. from allocation to exit from the study), the caregiver/patient will be asked to measure twice daily, at prespecified times, the following parameters using TM devices: arterial blood pressure, peripheral arterial haemoglobin saturation, tympanic temperature. Body weight will be evaluated once daily.
~The TM glucometer and TM electrocardiograph will be used exclusively by healthcare staff in case of patients in need of capillary blood glucose testing and according to clinical needs, respectively. All data will be automatically sent to a central interface and made readily available to physicians and nurses, to enable a prompt clinical response. In case of malfunctioning, a technical support will be ensured."
15805713|NCT04403646|Dietary Supplement|ARBOX|dry extract of polyphenols (tannins) form quebracho and chestnut 240 mg, B12 vitamin 0.72 µg
15805714|NCT04403646|Other|PLACEBO|Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for ARBOX
15805715|NCT04403633|Other|mobile health educational tool|Interactive educational tool delivered on iPad
15805716|NCT04403620|Radiation|Intensity-modulated Radiation Therapy (IMRT)|Patients will receive adjuvant radiation therapy using intensity-modulated radiation therapy (IMRT) within 8 weeks of surgical resection
15805717|NCT04403594|Other|dry needling|dry needling followed by functional electrical stimulation and treadmill training
15805718|NCT04403581|Other|Questionnaire|Questionnaire for assessing stresses, knowledge and attitudes of doctors in COVID-19 pandemic
15805719|NCT04403568|Drug|Ursolic Acid|Ursolic Acid 150mg
15805720|NCT04403568|Drug|Curcumin|Curcumin 600mg
15805721|NCT04403555|Drug|Ivermectin|Ivermectin treatment
15805722|NCT04403529|Drug|Traditional Chinese Medicine Formulation|"The prescription for breast cancer Traditional Chinese Medicine formulation is a combination of 12 herbal components and it is available in granules form to be dissolved in hot water for consumption."
15805878|NCT04402242|Device|Bispectral index + NOL index|Anesthesia monitoring
15806258|NCT04399070|Drug|ketamine|The depression patients received propofol and ketamine before ECT
15805723|NCT04403529|Drug|Placebo Formulation|"Placebo granules contains 5% prescription for breast cancer Traditional Chinese Medicine formulation and 95% filler, it is available in granules form to be dissolved in hot water for consumption."
15805724|NCT04403516|Drug|Dexamethasone Intracanalicular Insert, 0.4mg|To determine post-surgical resolution of pain and inflammation outcomes with DEXTENZA compared to topical steroid treatment in patients who undergo pterygium surgery.
15805725|NCT04403516|Drug|Prednisolone Acetate 1%|To reduce post-surgical pain and inflammation in patients who undergo pterygium surgery.
15805726|NCT04403503|Drug|Gelatin Sponge;Thrombin, Bovine 5000 IU Multiple Routes Kit [GELFOAM-JMI SPONGE KIT]|Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) (GS group)
15805727|NCT04403503|Drug|Cyanoacrylate, Isobutyl|Donor site was closed either with GS (Spongostan®, Ethicon, Somerville, USA) (GS group) and GS covered with high viscosity CY (PeriAcryl®, Glustitch Inc., Delta, Canada) (GS+CY group).
15805728|NCT04403490|Behavioral|HABIT-ILE|2 weeks HABIT-ILE
15805729|NCT04403490|Behavioral|Conventional intervention|2 weeks usual intervention (waitlist group)
15805730|NCT04403477|Biological|Convalescent plasma|Apheretic convalescent plasma from a COVID-19 survivor
15805731|NCT04403464|Behavioral|HABIT-ILE with REAtouch®|65h HABIT-ILE including 30h REAtouch®
15805732|NCT04403464|Behavioral|HABIT-ILE without REAtouch®|65h HABIT-ILE
15805733|NCT04403451|Behavioral|True North|Love Notes, Financial Stability, Jobs
15805734|NCT04403438|Other|ıt will be compared pain, sleep, fatigue, physical activity level and quality of life and questioning exercise habits before and after the covid-19 outbreak in patients with Behçet and FMF.|ıt will be compared pain, sleep, fatigue, physical activity level and quality of life and questioning exercise habits before and after the covid-19 outbreak in patients with Behçet and FMF.
15805735|NCT04403412|Procedure|Left atrial appendage closure group|Left atrial appendage closure Left atrial appendage closure is performed using a single endocardial plug devices guided by fluoroscopic guidance and transesophageal echocardiography
15805736|NCT04403412|Procedure|Radiofrequency ablation group|Radiofrequency ablation Each patient with persistent AF receives circumferential pulmonary vein isolation under the 3D electro-anatomical mapping system , and no additional ablation is performed in the extrapulmonary sites unless the patient is diagnosed with atrial flutter before the operation.
15805737|NCT04403412|Procedure|LAAC combined with radiofrequency ablation group|LAAC combined with radiofrequency ablation group Each patient received the same group of patients with simple radiofrequency ablation radiofrequency ablation treatment at the same time, the transcatheter occlusion of left atrial appendage opening
15805738|NCT04403399|Drug|Varenicline|Initial 0.25 mg oral dose of varenicline administered with monitoring over 4 hours, then total daily dose escalated over the next 2 days until final 0.5 mg BID oral varenicline administered for the remaining 3 weeks.
15805739|NCT04403399|Drug|Placebo|Initial placebo oral dose administered with monitoring over 4 hours, then total daily dose escalated over the next 2 days until final placebo BID dosing administered orally for the remaining 3 weeks.
15805740|NCT04403373|Behavioral|Waitlist control|waitlist control
15805741|NCT04403373|Behavioral|Moderate-intensity walking exercise|walking exercise
15805742|NCT04403373|Behavioral|Vigorous-intensity walking exercise|walking exercise
15805743|NCT04403360|Procedure|ESPB|Ultrasound guided performance of ESPB at T12 level after the induction of anesthesia but before the start of the surgery
15805744|NCT04403360|Procedure|Local infiltration by the surgeon|Local infiltration of anesthetics at surgical site after skin incision
15805745|NCT04403347|Dietary Supplement|Innovative Dietary Formulation (Patent ID: CN110250417A)|In addition to regular diets and usual care of hypertension, additional innovative natural dietary formulation derived from tartary buckwheat will be orally taken 3 times per day.
15805746|NCT04403347|Drug|Losartan 50mg per day|In addition to regular diets and usual care of hypertension, antihypertensive medication will be orally taken (Losartan 50mg per day).
15805747|NCT04403334|Drug|Levofloxacin Ophthalmic|0.1 ml of unpreserved 0.5% levofloxacin
15805748|NCT04403334|Drug|Moxifloxacin Ophthalmic|0.1 ml of unpreserved 0.5% moxifloxacin
15805749|NCT04403321|Drug|Tacrolimus|Tacrolimus will be given at 1mg bid with the target concentration to be 5-10 ng/ml.
15805750|NCT04403321|Drug|Placebo (for Tacrolimus)|placebo will be given at 1mg bid.
15805751|NCT04403321|Drug|Cyclosporin A|Cyclosporin A will be given started with 100mg bid with the target concentration to be 100-150 ng/ml throughout the study.
15805752|NCT04403308|Biological|ONO-7913|ONO-7913 will be administered by intravenous continuous infusion during the designated time.
15805753|NCT04403295|Behavioral|Collaborative Specialty Care|In specialty collaborative care, the specialty provider team will deliver health coaching and problem-solving treatment to GWVs and recommend the primary care team make monthly optimization of analgesics.
15805754|NCT04403295|Behavioral|e-consultation|In e-consultation the specialty provider team will make a onetime recommendation to the primary care team that the GWV locally receive health coaching and problem-solving treatment and analgesic optimization.
15805755|NCT04403282|Drug|Eflornithine Topical|Subjects will apply placebo to one side of beard and eflornithine to other side for 16 weeks.
15805756|NCT04403282|Drug|Placebo Eflornithine Topical|Subjects will apply placebo to one side of beard and eflornithine to other side for 16 weeks.
15805757|NCT04403269|Drug|IgIV|2 infusion at D1 and D2 (0.8 g / kg by IV infusion)
15805758|NCT04403243|Drug|Colchicine|0.5mg twice a day per os during the first three days and then 0.5mg daily per os if weight < 86 kg or 0.5mg twice a day per os if weight > 85kg for seven days.
15805759|NCT04403243|Drug|Ruxolitinib 5 MG|Ruxolitinib - 5mg twice a day per os for ten days
15805760|NCT04403243|Drug|Secukinumab 150 MG/ML Subcutaneous Solution [COSENTYX]|Secukinumab - 300mg subcutaneously as the first dose and then 150mg twice a day subcutaneously for ten days
15805761|NCT04403243|Other|standard therapy|standard therapy for COVID 19
15805762|NCT04403230|Procedure|Retreatment of teeth prepared without finish line|Retreatment of teeth treated using biologically oriented preparation technique (BOPT). The sample (149 teeth) was divided into two groups: Seventy four teeth restored with crowns, and 75 teeth supporting fixed partial dentures (FPD).
15805763|NCT04403217|Other|Individualized structured dietary plan based on MD|Participants will follow an individualized structured dietary plan based on Mediterranean diet for 12 weeks
15805764|NCT04403204|Other|Immunofluorescence Imaging|Patients will be administered FDA approved ICG through intravenous injection and imaged by a FDA approved surgical microscope (Spy Elite) which is 0.5 meter away from the subject. Both ICG fluorescence and the two imaging systems have been used for routine clinical practice for many years. Figure (a) shows the Schematic sketch of the imaging systems. ICG fluorescence imaging utilizes intravenously injected ICG, which is a fluorescent dye that is FDA-approved for clinical use, illuminated with near-infrared light. The ICG dye is indirectly activated and the dynamic fluorescence due to bone perfusion can be captured by a video rate imaging system.
15805765|NCT04403204|Other|DCE-MRI|Characterize the relationship between bone perfusion as quantified by ICG based DCE-FI and DCE-MRI in human patients to develop an accurate depth-sensitive fluorescence imaging model that will correct for the surface-weighted feature of fluorescence imaging
15805766|NCT04403191|Drug|Ondansetron|ondansetron 4 mg intravenous immediately once reached to I.C.U and another same dose after 6 hours while patients of group
15805767|NCT04403191|Drug|isopropyl alcohol 70% inhalation|inhalation every 15 min for 4 times then repeated after 6 hours
15805768|NCT04403191|Procedure|laparoscopic appendectomy|all patients received post operatively after laparoscopic appenectomy
15805769|NCT04403178|Diagnostic Test|Radiographic examination with a Migration of > 40 %|Radiographic examination
15805770|NCT04403165|Procedure|Nocturnal polysomnography (NPSG)|Nocturnal polysomnography (NPSG) to measure REM sleep and sleep spindles characteristics.
15805771|NCT04403165|Procedure|Lumbar Puncture (LP)|Lumbar puncture (LP) to measure CSF P-Tau, T-Tau and Aβ42/40 ratio.
15805772|NCT04403165|Other|PET-MR measurement with a norepinephrine transporter (NET)-selective radiotracer (S,S)-[11C]Omethylreboxetine ([11C]MRB)|PET-MR measurement with a norepinephrine transporter (NET)-selective radiotracer (S,S)-[11C]O-methylreboxetine ([11C]MRB) to measure NET availability.
15805773|NCT04403165|Behavioral|Psychomotor Vigilance Task (PVT)|Psychomotor vigilance task (PVT) and the OddBall to measure test taskattention performance.
15805774|NCT04403152|Other|Post-operative rehabilitation|Patients received the exercises programme for five days, 30 minutes, two times per day with supervision by a physical therapist.
15805775|NCT04403152|Other|Post-operative mobilization|Patients received usual mobilization programme for 2-5 minutes, two times per day the five days with supervision by a physical therapist.
15805776|NCT04403139|Drug|Shingrix|All participants will receive the FDA-approved recombinant zoster (RZV) vaccine (Shingrix) given at the approved dose and schedule.
15805777|NCT04403126|Other|forgiveness education intervention|The forgiveness education intervention primarily teaches the concept of forgiveness through stories. We chose the kind of stories that should appeal to children ages 10 through 12. Each lesson is planned according to the following procedure: story-telling/movie-watching, discussion, and in-class activities.
15805778|NCT04403113|Other|Structured neck and trunk stabilization exercises|Intensive structured neck and trunk stabilization exercises based on Neurodevelopmental therapy method-Bobath concept principles. These exercises were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
15805779|NCT04403113|Other|Feeding and oral motor intervention strategies|Feeding and oral motor intervention strategies program were performed for 6 weeks, 2 days a week, 45 minutes for a total of 12 sessions.
15805780|NCT04403113|Other|Caregiver training related to feeding|In caregiver training related to feeding; a) positioning and feeding technique during feeding, b) ensuring safety for aspiration, c) using suitable containers and ingredients, d) adjusting (adapting) food consistency properly, e) preparing small amounts of high-calorie, balanced diet and f) reducing food spillage while feeding and how to ensure efficacy for shortening the feeding time, g) providing appropriate postural and physical support for self-feeding. All of these activities were continued for 6 weeks with a home program.
15805781|NCT04403100|Drug|Hydroxychloroquine Sulfate Tablets|Tablets of 400 mg: Loading dose of 02 tablets followed by one tablet of 400 mg orally on the following 09 days
15805782|NCT04403100|Drug|Lopinavir/ Ritonavir Oral Tablet|tablets of 200/ 50 mg; Loading dose of 04 tablets twice a day on day 1 followed by two tablets twice a day on the following 09 days
15805783|NCT04403100|Drug|Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral Tablets|"Hydroxychloroquine Oral Tablet 400 mg: Loading dose of 02 tablets followed by one tablet of 400 mg orally on the following 09 days
~plus
~Lopinavir/ Ritonavir Oral Tablet of 200/ 50 mg: Loading dose of 04 tablets twice a day on day 1 followed by two tablets twice a day on the following 09 days"
15805784|NCT04403100|Drug|Placebo|Placebo tablets - 01 tablet twice daily from day 01 through day 10.
15805785|NCT04403087|Drug|Trimebutine 100 MG|Trimebutine 100mg three times a day
15805786|NCT04403074|Procedure|Celiac Plexus Neurolysis|When CPBs are not effective (less than one month of relief) then a Celiac Plexus Neurolysis may be completed to manage pain associated with Chronic Pancreatitis.
15805787|NCT04403061|Diagnostic Test|Cytokines measurement|Quantification of plasma cytokine levels of human GM-CSF, IFN-α, IFN-γ, IL-2, IL-4, IL-5, IL-6, IL-9, IL-10, IL-12p70, IL-17A, and TNF-α using multiplex technol-ogy (quantitative measure).
15805788|NCT04403061|Diagnostic Test|Cellular response|SARS-CoV-2 peptides (Prot-S, Pros-N and Port-M) will be used to activate CD4 and CD8 T cells. Cytokines released, such as IFNg, TNFa, IL4, IL17A, and IL2, from each cell subset will be measured by flow cytometry (quantitative measure).
15805789|NCT04403061|Diagnostic Test|TLRs activation measurement|After specific cell activation through TLR7/8 receptors, such as resiquimod, ORN R-0002, ORN R-0006, ORN R-1263, ORN R-2336, and controls as Poly (I:C), the release of IFNa, IFNg, TNFa, IL12, and IL6 will be analyzed (quantitative measure).
15805790|NCT04403061|Diagnostic Test|KIR phenotype evaluation|Characterization of the presence of 14 genes plus 2 pseudogenes of KIR gene family (qualitative genotyping) by PCR, mRNA expression profiling (quantitative measures) by RT-PCR, and phenotyping of human NK cells analyzing different KIR receptors (quantitative measure) by flow cytometry, will be analyzed.
15805791|NCT04403048|Procedure|Provisional DCB approach PCI procedure|Intervention is explained in detail in group description
15805792|NCT04403048|Procedure|Standard provisional approach PCI procedure|Intervention is explained in detail in group description
15805793|NCT04403035|Diagnostic Test|ID NOW vs. Accula|Comparison of the ID Now assay vs. the Accula assay in detecting Covid-19.
15805879|NCT04402216|Behavioral|Child Life-led preparation|Support from a certified child life specialist in preparation for MRI
15805795|NCT04403009|Other|no intervention|no intervention
15805798|NCT04402983|Other|Physiotherapy|Program content Respiratory exercise (chest breathing, diaphragmatic breathing, basal expansion exercises), Breath control training, Active breathing techniques cycle Light aerobic exercise Posture exercises Self walking
15805799|NCT04402970|Drug|Dornase Alfa Inhalation Solution|Nebulized dornase alfa
15805800|NCT04402957|Drug|LSALT peptide|LSALT, a peptide drug with the sequence NH3-LSALTPSPSWLKYKAL-COOH, binds to dipeptidase-1 (DPEP-1) but does not inhibit its biologic enzymatic activity, potentially minimizing off-target or other adverse effects. LSALT peptide inhibits leukocyte recruitment in multiple experimental disease models through the direct inhibition of leukocyte adhesion to DPEP-1 present in lungs, kidney, and liver. DPEP-1 represents a new molecular pathway for leukocyte adhesion discovered by Arch Biopartners scientists.
15805801|NCT04402957|Drug|Placebo|0.9% saline solution
15805802|NCT04402944|Drug|Pulmozyme|Pulmozyme 2.5 mg BID
15805803|NCT04402944|Drug|Placebo|Saline 2.5 mL BID
15805804|NCT04402931|Procedure|Transcatheter Valve-in-Valve Intervention|Transcatheter mitral valve-in-valve implantation with SAPIEN 3
15805805|NCT04402931|Procedure|Redo Mitral valve surgery|Transcatheter Valve-in-Valve Intervention
15805806|NCT04402918|Diagnostic Test|biological samples day of delivery|mother samples: serology, viremia, nasopharyngeal swab, vaginal swab, placenta swab, piece of placenta newborn: serology, viremia, nasopharyngeal aspiration
15805807|NCT04402892|Other|35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (hospitalized Patients )|Patients hospitalized for CoV-2-SARS will be sampled at inclusion (Day 0), at day 21, at 3 months and at 6 months .
15805808|NCT04402892|Other|35 ml blood, 5 tubes LITHIUM HEPARINATE at each time (cured Patients)|Patients who have recovered from CoV-2-SARS will be sampled at inclusion (Day 0), at 3 months and at 6 months .
15805809|NCT04402879|Procedure|Prone Positioning (PP)|"The intervention for this study is PP. Patients at participating sites allocated to the intervention arm of the study will be prompted by ward nurses and respiratory therapists to assume and maintain a prone position for varying durations, four times per day until the occurrence of a primary outcome event or hospital discharge.
~The target duration (dose) of PP is > 8 hours per day for up to 60 days, or until oxygen requirements are < 2 L per minute or < 2 L per minute above baseline home oxygen requirements."
15805810|NCT04402866|Drug|TD-0903|Study Drug to be administered by inhalation
15805811|NCT04402866|Drug|Placebo|Placebo to be administered by inhalation
15805812|NCT04402853|Diagnostic Test|Tears swab|rtPCR on tears swabs samples
15805813|NCT04402840|Procedure|Stellate Ganglion Block|The procedure will be done at the bedside in the ICU without interfering with ongoing treatment.
15805815|NCT04402814|Diagnostic Test|Clungene rapid test cassette|Blood will be tested for the presence of IgG and IgM antibodies using the Clungene rapid test cassette.
15805818|NCT04402775|Other|Tourniquet|A tourniquet will be used during surgery
15805819|NCT04402762|Drug|Ovine Enoxaparin|The test drug is ovine enoxaparin sodium 60 mg (0.6 mL taken from 1.0 mL vial containing 100 mg = 10,000 IU anti-FXa), from Metiska Farma.
15805820|NCT04402762|Drug|Enoxaparin Prefilled Syringe [Lovenox]|The reference drug is enoxaparin sodium 60 mg (Lovenox® 0.6 mL prefilled syringe containing 60 mg = 6,000 IU anti-FXa) from Sanofi, France.
15805821|NCT04402749|Other|Nephrectomy|Patients underwent nephrectomy
15805822|NCT04402736|Behavioral|The modified Barthel Index-based rehabilitation nursing program|The intervention with the program based on the MBI classified function of patients into five levels, with every 20 points as a level, Each level corresponds to different training items. Training items included self-care training and training in transfer activities, sitting balance, walking, and sit-to-stand, etc. Each training session lasting at least 30 minutes, two sessions per day, for seven continuous days. During the intervention, the rehabilitation therapist's conventional treatment is not interfered.
15805823|NCT04402736|Behavioral|Usual care|Patients in the control group received clinical usual care including the activities of daily living assessment, early mobilization guide and health education. During the intervention, the rehabilitation therapist's conventional treatment is not interfered.
15805824|NCT04402723|Drug|Donafenib|In first 28-days-cycle, eligible subjects will be given Donafenib 0.2/0.3g, bid, for first 14 days, combination with Daunorubicin 60mg/m2/d, for first 3 days, and Cytarabine 100mg/m2/d, for first 7 days. If CR or CRi is observed, subjects will be given Donafenib 0.2/0.3g, bid, for first 14 days, combination Cytarabine 2g/m2/q12h, for first 3 days, in next 28-day-cycle.
15805825|NCT04402710|Behavioral|Self-compassion|Six week behavioural change program plus a self-compassion intervention aimed to increase physical activity among individuals with prediabetes
15805826|NCT04402710|Behavioral|Control Group|Six week behavioural change program aimed to increase physical activity plus information on general health topics.
15805827|NCT04402697|Other|Dietary and physical activity intervention|"OW-OB group: 6-month program of weight loss consisting in a low-calorie food plan (30% reduction in the individual energy requirements) with dietary sessions and exercise counselling.
~MONW group: 6-month program to improve eating habits (Mediterranean diet) with dietary sessions and exercise counselling."
15805828|NCT04402671|Other|non-cross-linked porcine skin collagen membrane|non-cross-linked porcine skin collagen membrane used is Bioguide, Geistlisch Pharma AG, Wolhusen, Switzerland.
15805829|NCT04402671|Other|glutaraldehyde cross-linked bovine collagen membrane|glutaraldehyde cross-linked bovine collagen membrane GCLM used is RTM Collagen®, Osteogenics Biomedical, Lubbock, TX, USA.
15805830|NCT04402658|Drug|Inhaled salbutamol|Participants will inhale 800 μg salbutamol (or placebo) using a standard metered dose inhaler used for asthma treatment, and a standard spacer device will be used to allow optimal delivery of the drug to the lung. The inhaler delivers 100 μg of salbutamol with each actuation (i.e., 8 puffs/actuations gives 800 μg) with inhalation time being approximately ~2 min (10 breaths) and the manufacturer's user instructions will be followed. Although complete uptake of salbutamol cannot be concluded as any salbutamol left in the spacer, mouth or remaining in the lung will be not measured. This dose of Salbutamol is chosen because it is the highest dose permitted by the World Anti Doping Agency (WADA).
15805831|NCT04402632|Procedure|Surgical Management|SDH Evacuation (Control)
15805832|NCT04402632|Device|Surgical Management + Treatment|SDH Evacuation + Embolization
15805833|NCT04402632|Other|No Treatment|Observation Only (Control)
15805834|NCT04402632|Device|Treatment|Embolization
15805835|NCT04402619|Behavioral|Cognitive behavior therapy|"The ten modules cover:
~Psychoeducation about sleep, sleep problems, and associations with alcohol
~How to keep and use a sleep diary
~Sleep hygiene
~Sleep compression
~Cognitive restructuring
~Emotional regulation
~Preparing for the future"
15805836|NCT04402606|Other|Evaluation on skin toxicities|Measurements will be carried out using specific tools, such as the cutaneous ultrasound system (measurement of the skin layers thicknesses, the cutometer (measurement of the elasticity of the skin), the corneometer (measurement of the hydration of the skin), the pH meter (measuring the pH of the skin), the colorimeter (measuring the color of the skin), the tewameter (measuring the insensible loss of water), the sebometer (measuring sebum).
15805837|NCT04402593|Behavioral|Modified Heidelberg Model of Neuro-Music Therapy|6 sessions, 2 sessions a week including the following interventions: resonance training, music relaxation, Intonation Training and session review/homework.
15805838|NCT04402580|Drug|Rituximab Biosimilar|for dosage between 100 and 250 mg Rituximab will be diluted in 100 ml of normal saline and administered at 2 ml/h for the first 30'; 3 ml/h for the second 30'; 6 ml/h for the third 30'; 15 ml/h until the end. For dosage between 260 and 500 mg Rituximab will be diluted in 250 ml of normal saline and administered at 6 ml/h for the first 30'; 9 ml/h for the second 30'; 18 ml/h for the third 30'; 36 ml/h until the end. For dosage between 510 and 1000 mg Rituximab will be diluted in 500 ml of normal saline and administered at 9 ml/h for the first 30'; thereafter, the infusion rate can be doubled every 30 minutes up to a maximum of 72 ml/h.
15805839|NCT04402580|Drug|Mycophenolate Mofetil|1,200 mg/1,73 sqm orally divided in 2 daily doses
15805840|NCT04402567|Other|No Intervention|Not Apply
15805841|NCT04402554|Behavioral|Cannabis questionnaire|The effectiveness and use of cannabis in the management of chronic pain has been well known for many years, but has so far been illegal and therefore largely unacknowledged. We hypothesize that the use of cannabis in this population of patients with chronic joint or spinal pain is not anecdotal and responds to a need to further improve the overall management of patients. The objective of our anonymous questionnaire is to estimate the prevalence of cannabis use in patients with chronic inflammatory rheumatism.
15805842|NCT04402541|Drug|CB-5339|25mg and 75mg capsules
15805843|NCT04402528|Behavioral|Behavioral tools integrated within mehealth for ADHD software|Integrated functionality within the mehealth for ADHD software allows parents and teachers/childcare providers to set up and deliver behavioral interventions such as daily report card systems and home-based program such as star charts. Automated wizards lead parents and teachers through the process of selecting target behaviors and setting up reward schedules. Baseline data is gathered online and algorithms derive a set of behavioral goals for the child. Thereafter, parents or teachers record the child's performance directly into the software. Once behavioral monitoring begins, parents and teachers receive daily email or text communications from mehealth for ADHD alerting them to the daily rewards earned by their child. Finally, online algorithms exist that detect how a child is doing in meeting behavioral goals and prompt users to modify goals accordingly.
15805844|NCT04402515|Drug|TIO/OLO|Tiotropium/Olodaterol
15805845|NCT04402515|Drug|ICS|inhaled cortocosteroids
15805846|NCT04402502|Device|Ultrasound Imaging|The participant will go to the Rheumatology clinic (St. Joseph's Hospital) and have 3D hand ultrasound performed on their hands.
15805850|NCT04402476|Device|Powder Free Polychloroprene Surgical Gloves, Sterile. Low Dermatitis Potential, tested for use with Chemotherapy drugs.|Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact.
15805851|NCT04402463|Other|Global Postural Reeducation|"The participants will receive treatment along 4 weeks, 2 sessions per week, and 40-45 minutes each session.
~In the treatment 3 of the therapeutic postures of GPR method to will carry out following Souchard's principles of Global Postural Reeducation"
15805852|NCT04402463|Other|Exercise Therapeutic|"The participants will receive treatment along 4 weeks, 2 sessions per week, and 40-45 minutes each session.
~The treatment will be divided into 3 phases, where it initially starts with phase 1 (3 treatments) and progresses to phase 2 (3 treatments) until reaching stage 3 (2 treatments)."
15805853|NCT04402450|Procedure|Ultrasound-guided suprainguinal fascia iliaca nerve block|After an ultrasound-guided insertion of a block needle below the inguinal ligament, the needle will be advance in the plane between fascia iliaca and iliopsoas muscle up to a point cranial to the ligament in order to inject a 40 mL of adrenalized 0.25% levobupivacaine.
15805854|NCT04402450|Procedure|Ultrasound-guided pericapsular nerves group of the hip block|After an ultrasound-guided insertion of a block needle at the level of the inguinal ligament, the needle will be advance into the plane between iliac bone periosteum and the tendon of the iliopsoas muscle in order to inject 20 mL of adrenalized 0.5% levobupivacaine.
15805855|NCT04402437|Procedure|LP Block|Subjects randomized to the lumbar plexus block group will receive a subcutaneous lidocaine skin wheal 3-4 cm lateral to midline on the operative side along the intercristal line. A nerve stimulator will be sent to 1-1.5mA and a stimulating needle inserted perpendicular to the skin. The needle will be advanced slowly until the quadriceps muscle is stimulated and maintained at less than 0.6mAs. Ropivacaine (20ml, 0.5%) will be injected slowly with frequent aspiration to rule out inadvertent intravascular needle placement.
15805856|NCT04402437|Procedure|QL Block|Subjects randomized to the quadratus plexus block group will receive a subcutaneous lidocaine skin wheal that will be placed after ultrasound identification of external oblique, internal oblique, transverse abdominus and quadratus lumborum muscles. A needle will then be advanced under ultrasound guidance below the internal oblique aponeurosis and lateral to the quadratus lumborum muscle. Ropivacaine (20ml, 0.5%) will be injected slowly with frequent aspiration to rule out inadvertent intravascular needle placement. Local anesthetic injection will also be observed with real time ultrasound guidance.
15805857|NCT04402424|Diagnostic Test|Faecal Immunochemical Testing|Stool samples for both point of care and laboratory based faecal immunochemical testing via device specific sampling sticks
15805858|NCT04402411|Procedure|Quadratus lumborum block|The patient will be placed in a lateral position with the side to be blocked facing upwards. The ultrasound probe will be properly sterilized and with sterile covers. An 18-20 gauge blunt tipped block needle or a Tuohy needle is advanced under ultrasound guidance on the posterior aspect of the Quadratus Lumborum. The QL muscle is identified with its attachment to the lateral edge of the transverse process of the L4 vertebral body. With the psoas major muscle anteriorly, the erector spinae muscle posteriorly and the QL muscle adherent to the apex of the transverse process, a well recognisable pattern of a shamrock with three leaves can be seen.
15805859|NCT04402411|Procedure|Transversus abdominis plane block|"The patient will be supine while performing the block and sterilization of the site of the ultrasound and needle entry will be performed.
~The ultrasound probe is placed in a transverse plane to the lateral abdominal wall in the midaxillary line, between the lower costal margin and iliac crest.
~The needle is introduced in plane of the ultrasound probe directly under the probe and advanced until it reaches the plane between the internal oblique and transversus abdominis muscles."
15805860|NCT04402411|Drug|Intravenous opioid|Patients will receive morphine 0.1 mg/kg
15805861|NCT04402385|Drug|Aspirin 81 mg|Participants randomized to 81 mg of Aspirin daily
15805862|NCT04402385|Drug|Placebo|Participants randomized to placebo daily
15805863|NCT04402372|Device|Novel bidirectional cannula (BiflowTM, LivaNova, Italy)|We are going to evaluate the safety and efficacy of the novel bidirectional cannula (BiflowTM, LivaNova, Italy) with specific design to ensure stable distal perfusion compared to conventional cannula with downstream line in patients undergoing femoral arterial cannulation for CPB during minimally invasive surgery
15805864|NCT04402359|Drug|meropenem|meropenem one gram slowly IV infusion every 8 hours for 14 days
15805865|NCT04402359|Drug|ceftazidime 2 grams and avibactam 500|received ceftazidime 2 grams and avibactam 500 mg every 8 hours for 14 days in solution for injection(sodium chloride 9 mg/mL (0.9%), sodium chloride 4.5 mg/mL, dextrose 25 mg/mL, 0.45% sodium chloride, 2.5% dextrose and/or Lactated Ringer's solution).
15805866|NCT04402359|Device|ventilator|all patients selected to be ventilated for 14 days
15805867|NCT04402346|Procedure|Radiofrequency-assisted pancreas transection|Transection of the pancreas in distal pancreatectomy by applying a radio frequency device
15805868|NCT04402346|Procedure|Stapler assisted pancreas transection|Transection of the pancreas in distal pancreatectomy by applying a stapler device with/without seamguard
15805869|NCT04402333|Procedure|Robotic Interval Debulking Surgery|Interval debulking surgery carried out in a minimally invasive manner using the Da Vinci Robot.
15805870|NCT04402320|Drug|Midazolam|reconnected to mechanical ventilation before extubation for one hour with sedation with midazolam 3-5 milligram/hour intravenous infusion to achieve score 0 or -1on Richmond Agitation - Sedation Scale (RASS). 20 minutes before the end of this hour midazolam infusion discontinued and patients awaked. Patient put on mechanical ventilation (MV) with the following parameters, FIO2 40%, pressure SIMV mode, PEEP 8 cmH2O, Pressure support 15 cmH2O, Respiratory rate 14/min, Peak inspiratory pressure (PIP) of 35 cmH2O. Then patients extubated and followed our previous protocol without the use
15805871|NCT04402320|Device|ventilator|reconnected to mechanical ventilation before extubation for one hour with sedation
15805872|NCT04402307|Other|Chin Tuck Against Resistance|Training in 6 weeks 3 times a day.
15805873|NCT04402294|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|The investigators will create individualized TMS targets using deep learning methods on task and resting fMRI data to target working memory augmentation. The individualized target will be stimulated in a subsequent fMRI scan involving working memory task performance interleaved with repetitive TMS (rTMS) delivered at a variety of stimulation frequencies. Based on activation readouts in response to rTMS, an optimal and sub-optimal brain state frequency to impact working memory performance will be selected for each participant. Participants will receive rTMS at each frequency separately for three days (six days total), with the order of frequency randomly assigned and counterbalanced. Following each three day protocol, another fMRI working memory readout will be conducted to support the targeting and frequency selection algorithms.
15805874|NCT04402281|Diagnostic Test|suPAR algoritm|All medical patients attending to the ED and who will have blood drawn for routine examination will be part of the study. In patients with low suPAR (green group, suPAR below 3 ng/ml) and in patients with high suPAR (red group, suPAR > 6 ng/mL) the Intervention will be carried out
15805875|NCT04402268|Device|Cardioverter-defibrillator|We analyzed how many HCM patients reached an end-point of sudden cardiac death defined as adequate intervention of cardioverter-defibrillator or sudden cardiac arrest.
15805876|NCT04402255|Other|pilates exercise|The key elements of Pilates during supine, prone, side-lying and standing positions will be taught. These key elements are: breathing (diaphragmatic), focusing (neutral position), rib cage placement, shoulder placement, head and neck placement (neutral position). Then, Pilates based 'mat' exercises will be performed by the physiotherapist in the clinic for 8 weeks, 2 days / week, 16 sessions. Each session will be programmed to be 45 minutes. During all exercises, including warm-up and cooling, patients will be asked to provide key elements and protect them during movements. Depending on the condition of the patients, the exercises will be advanced from easy to difficult.
15805877|NCT04402242|Device|Bispectral index|Anesthesia monitoring
15805880|NCT04402216|Behavioral|MRI preparation video|A descriptive video about what to expect when undergoing MRI
15805881|NCT04402216|Behavioral|KindVR Virtual Reality MRI Preparation Experience|A VR experience to prepare pediatric patients for MRI, to be used in addition to support from a certified child life specialist
15805882|NCT04402203|Drug|Favipiravir|Favipiravir 200 mg (Favipira) tablet will be given orally. Day 1: Tablet Favipiravir 1600 mg twice daily Days 2-Days 10: Tablet Favipiravir 600 mg twice daily.
15805883|NCT04402203|Drug|Only Standard Treatment|Standard treatment included oxygen inhalation, oral or intravenous rehydration, electrolyte correction, antipyretics, analgesics, antibiotics and antiemetic drugs & the medication any patient is on due to any concomitant diseases.
15805884|NCT04402177|Drug|Methyl Prednisolonate|Corticosteroid treatment
15805885|NCT04402164|Device|Herbst appliance|telescopic appliance for mandibular advancement
15805886|NCT04402151|Drug|PSMA PET/MR - Gallium-68 labeled PSMA-HBED-CC|"Patients enrolling on the protocol will undergo prostate-specific membrane antigen (PSMA) Positron Emission Tomography (PET)/Magnetic Resonance(MR) prior to start of the radiation treatment planning process. PSMA tracer is administered by IV injection and PET images are acquired.
~Any patients found to have possible metastatic disease will undergo a standard of care confirmatory biopsy (if feasible) and receive treatment appropriate for their stage.
~The PSMA PET/MR scan will be performed prior to initiation of androgen deprivation therapy (ADT)."
15805887|NCT04402151|Radiation|Stereotactic Body Radiation Therapy (SBRT)|Patients will receive standard of care radiation therapy (SBRT)
15805888|NCT04402138|Drug|Acalabrutinib|Acalabrutinib 100 mg BID will be self-administered orally starting from 100 day (+/- 7 days) Post-BMT on a 28-day schedule, with or without food, until the patient has reached approximately 2 years post-BMT.
15805889|NCT04402125|Behavioral|TargEted MAnageMent Intervention (TEAM)|"TEAM targets acquisition of self-management expertise and use of healthy behaviors that are intended to reduce stroke risk and burden. TEAM participants will continue in their regular medical care, supplemented by the TEAM intervention. Components are as follows:
~A 60 minute initial session in which the nurse and the PED meet with the patient who has experienced stroke or TIA. The initial session will cover introductions, orientation, and logistic planning.
~Five 60-minute group sessions with 6-10 stroke survivors (and their care partners as applicable) held approximately 4 weeks, 6 weeks, 8 weeks, 10 weeks, and 12 week after enrollment. Sessions are co-lead by a nurse and a PED.
~Six brief telephone sessions implemented after the conclusion of the 5 TEAM group sessions. Calls will be conducted every 2 weeks for 12 weeks. Calls will reinforce group session content, provide social support and facilitate linkage with other care providers."
15805890|NCT04402112|Drug|Pitavastatin|1mg, 2mg, or 4mg, Once a day, at least 8 weeks
15805891|NCT04402073|Drug|Sonidegib|Sonidegib is a selective smoothened inhibitor that inhibits the sonic hedgehog-signaling pathway. It is used in patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy.
15805892|NCT04402073|Drug|Cisplatin|Cisplatin (CIS) is a platinum derivate used in the treatment in several epithelial tumours. The application route is through the veins.
15805893|NCT04402073|Drug|Lomustine|Lomustine is a nitrosourea used in the treatment of brain tumours and Hodgkin's disease. The application route is oral.
15805894|NCT04402073|Drug|Vincristine|Vincristine sulfate (VCR) is an inhibitor of microtubule formation in the mitotic spindle, resulting in an arrest of dividing cells at the metaphase stage. Vincristine sulfate is indicated in acute leukemia, Hodgkin's disease, non-Hodgkin's lymphomas, rhabdomyosarcoma, neuroblastoma, and Wilms' tumor. The application route is through the vein.
15805895|NCT04402073|Radiation|radiotherapy|Radiotherapy to the cranio-spinal axis of 35.2 Gy in 22 daily fractions of 1.6 Gy, followed by an additional boost to the tumour site of 19.8 Gy in 11 daily fractions of 1.8 Gy, summing up to a total dose of 55.0 Gy in 33 daily fractions of 1.6/1.8 Gy.
15805896|NCT04402060|Drug|APL-9|Complement (C3) Inhibitor
15805897|NCT04402060|Other|Vehicle Control|Normal saline of equal volume to active arm
15805898|NCT04402047|Other|Electroacupuncture|We will apply Ashi points, Ex-UE9, SI3, and TE5. Sterile needles (0.3mm× 40mm) and SDZ-V EA apparatus will be utilized. Acupuncturists will insert needles perpendicularly into Ashi points for approximately 2-3mm until they pierce into the bone surface; acupuncturists will insert needles horizontally into Baxie points towards the wrist with a depth of 5-10mm; and acupuncturists will insert needles perpendicularly into SI3 and TE5 for approximately 5-10mm. All needles except Ashi points will be manually manipulated to achieve De qi. The needles at Baxie 1 and Baxie 4 will be connected using alligator clips from the EA apparatus. The electrical stimulation will last for 30 minutes with a continuous wave of 10 Hz and a fixed current intensity of 0.5 to 2 mA. All the needles will be retained for 30 minutes. Participants will undergo EA treatment three times per week for a total of 12 sessions in four consecutive weeks. If bilateral hands were affected, both sides will be treated.
15805899|NCT04402047|Drug|Topical diclofenac sodium gel|The gel will be gently rubbed over the affected joints without excessive joint movement four times per day for 4 weeks and will be asked not to wash hands for one hour after application. Each hand treatment will be used in identical dispensing doses of gel (4 cm strip, approximately 2g, which was judged sufficient for approximately half the surface of each hand (200 cm2)). Dosing times should be distributed evenly over waking hours.If bilateral hands were affected, both sides will be treated.
15805900|NCT04402034|Behavioral|Application of tele-rehabilitation|Individuals that will perform the virtual reality intervention.
15805901|NCT04402021|Behavioral|Outdoor Walking|Unsupervised outdoor walking will be the mode used for moderate-intensity aerobic exercise. The walking intervention will consist of 3 sessions (completed within the span of 7 days) that are conducted in the morning.
15805902|NCT04402021|Other|Quiet Rest|The quiet rest condition will consist of watching a nature documentary in a quiet room. The quiet rest intervention will consist of 3 sessions (completed within the span of 7 days) that are conducted in the morning.
15805903|NCT04402008|Drug|Poziotinib Once Daily Dosing|The poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration.
15805904|NCT04402008|Drug|Poziotinib Twice Daily Dosing|The poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration.
15805905|NCT04402008|Drug|Poziotinib Once Daily Dosing or Twice Daily Dosing as determined in Phase 1|The poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration.
15805906|NCT04401995|Drug|CMP-001|A molecule comprised of a 30 nucleotide strand, flanked by 10 guanines on either end. The nucleotide strand is surrounded by a Qβ viral-like protein. The intended mechanism of action of CMP-001 in oncology is the activation of TLR9 in pDC within the tumor or the tumor-draining lymph nodes (tumor-associated pDC).
15805907|NCT04401995|Biological|Nivolumab|a fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
15805908|NCT04401995|Other|[18F]F-AraG PET/CT|[18F]F-AraG is an 18F-labeled analog of arabinofuranosylguanine (AraG), a compound that has shown remarkably selective accumulation in T cells. It has several advantages over conventional [18F] and existing small molecule PET agents being investigated for immuno-monitoring. [18F]F-AraG has lower accumulation and more efficient efflux from cancer cells than a dCK agent.
15805909|NCT04401982|Drug|Netarsudil ophthalmic solution 0.02% one drop nightly for 1-2 weeks|Netarsudil ophthalmic solution 0.02% one drop nightly for 1-2 weeks will be administered
15805911|NCT04401943|Other|online fatigue intervention|on line teleconferencing fatigue intervention for 6 weeks on causes of fatigue, ways to protect joint and save energy, ways to manage stress, pain, good eating habits, and exercise.
15805912|NCT04401917|Drug|FNOS|[18F]NOS is an investigational radiotracer which each subject will have one [18F]NOS positron emission tomography/computed tomography (PET/CT) scan performed.
15805913|NCT04401904|Drug|Dapagliflozin 10 mg|10 participants randomized to receive 12 weeks of daily dapagliflozin 10mg by mouth
15805914|NCT04401904|Behavioral|Nutritional counseling|10 participants randomized to receive 12 weeks of weekly counseling on nutrition
15805915|NCT04401891|Behavioral|Formal pre-operative education|One group of patients will receive formal pre-operative education prior to surgery from an occupational or physical therapists while the other group of patients will only receive routine education in the MD office.
15805916|NCT04401878|Drug|Sphenopalatine Ganglion Block using 2% lidocaine|Sphenopalatine Ganglion Block is performed by a hollow culture swab that is connected with a 21-gauge syringe filled with three ml 2% lidocaine, inserted parallel to the floor of the nose until resistance is felt. The swab is at the posterior pharyngeal wall superior to the middle turbinate. The applicator was kept in the nostril for five to ten mins. The same procedure is done also in the second nostril. The patients are then examined by TCD.
15805917|NCT04401865|Combination Product|PXL-330 Platinum device for crosslinking with Peschke riboflavin solution|Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea
15805918|NCT04401852|Drug|MgSo4|a single bolus dose of 4g MgSO4 slowly intravenous over 15-20 minutes without maintenance dose.
15805919|NCT04401852|Drug|Isotonic saline|equal volume of isotonic 0.9% saline over 15-20 minutes
15805920|NCT04401839|Drug|Oxytocin IV shot|Oxytocin 10 IU I.V shot administered at the time of delivery of the anterior shoulder of the baby
15805921|NCT04401839|Drug|Oxytocin IV drip|administration of oxytocin 5 IU units IM (WHO GDG recommendations,2012) and waiting for signs of placental separation
15805922|NCT04401839|Procedure|Amr maneuver|sustained traction downward and posteriorly was applied to anterior and posterior lips of the cervix using ovum forceps for approximately 90 seconds
15805923|NCT04401826|Procedure|Tunneling micro-surgical crown lengthening approach using piezo-surgery|excess gingiva is eliminated. 2 mm bone is removed from CEJ-bone crest with piezo surgery via tunneling
15805924|NCT04401826|Procedure|Micro-surgical crown lengthening approach using Piezosurgery|excess gingiva is eliminated. 2 mm bone is removed from CEJ-bone crest with piezo surgery with conventional flap elevation.
15805925|NCT04401813|Drug|IBI308 200mg|Received IBI310 combined with sintilizumab 200mg
15805928|NCT04401787|Procedure|Anterior resection for upper rectal cancer in obese|Anterior resection for upper rectal cancer in obese
15805929|NCT04401774|Drug|Nivolumab|Nivolumab will be given every 4 weeks at 480mg flat dose intravenously for one year (total of 13 nivolumab doses).
15805930|NCT04401761|Drug|Rivaroxaban (BAY59-7939, Xarelto)|2.5 mg twice daily
15805931|NCT04401761|Drug|Acetylsalicylic acid|75 - 100 mg once daily at the discretion of the investigator
15805932|NCT04401748|Drug|Venetoclax|Tablet: Oral
15805933|NCT04401748|Drug|Azacitidine|Subcutaneous (SC) or Intravenous (IV) injection
15805934|NCT04401748|Drug|Placebo|Tablet; Oral
15805935|NCT04401735|Drug|Polydeoxyribonucleotides|PDRN injection to epidural space
15805936|NCT04401735|Drug|Normal saline|Normal saline
15805937|NCT04401722|Procedure|PANCREATICODUDENECTOMY|dissection and removal of periampulary tumour with 3 reconstruction PJ, HJ, and GJ
15805938|NCT04401709|Drug|Gemcitabine/Capecitabine|gemcitabine 1,000 mg / m2 IV on day 1, 8, and 15 of each cycle Capecitabine 1,660mg / m2 PO twice daily 1 ~ 21 days for 4 weeks
15805939|NCT04401709|Drug|Capecitabine|total 8 cycles Capecitabine 1,250 mg / m2 PO twice daily 1 ~ 14 days for 3 weeks
15805940|NCT04401696|Device|Bubble CPAP|"The bCPAP will be delivered using an oxygen flow meter as the oxygen source. This inspiratory limb containing oxygen from the flow meter will be connected to humidifier and tubing from humidifier will be connected to short binasal prongs, which would be applied to neonate with the help of adhesive bandage on both cheeks. It will be ensured that binasal prongs make appropriate seal. An orogastric tube will be placed for gastric decompression. A 1000 ml/500ml bottle filled with sterile water be used and marks will be made on it at 1cm distance, with '10' marked at base and '0' mark at the water interface.
~The expiratory limb from the nasal prongs was connected to tubing that will be dipped in water up to the desired level to provide positive end expiratory pressure. Pressure is varied by varying the depth of the dipped end of tubing."
15805941|NCT04401696|Other|Nasal Oxygen|The oxygen will be delivered from a wall oxygen source, delivered between 1 to 6 L/min and the rate varied via a flow regulator.
15805968|NCT04401462|Procedure|Tension band wiring or plate fixation|Operative fixation of olecranon fracture with either of the methods mentioned in the intervention name
15805942|NCT04401683|Device|Home-based rehabilitation with a digital biofeedback system|"Participants in the experimental group will perform a 12-week digital exercise program, to be performed independently at home using the SWORD Phoenix® medical device, under remote monitoring from a physical therapist.
~Additionally, both groups will have access to standard medical treatments and to an educational program, specifically developed to target chronic low back pain, consisting of a booklet containing pathology-related information, causes, treatment recommendations, as well as suggestions of cognitive behavioural therapy exercises."
15805943|NCT04401683|Other|Conventional home-based rehabilitation|"Participants in the control group will benefit from a 12-week home-based rehabilitation program, consisting of 12 face-to-face sessions (1 per week) with a physical therapist, complemented by additional non-supervised sessions. Both supervised and unsupervised sessions will follow the same set of exercises defined for the experimental group.
~Additionally, both groups will have access to standard medical treatments and to an educational program, specifically developed to target chronic low back pain, consisting of a booklet containing pathology-related information, causes, treatment recommendations, as well as suggestions of cognitive behavioural therapy exercises."
15805944|NCT04401670|Other|HPV screening and triage tests|The participants underwent a pelvic exam to have a provider-collected sample placed in PreservCyt [Hologic, Inc., Bedford, MA, USA] and a visual inspection by acetic acid (VIA) by a nurse.
15805945|NCT04401670|Behavioral|HPV self-sampling|"The participant was escorted by the nurse to a private room and given instructions on how to self-collect their sample using Just for Me sampler [Preventive Oncology International, Cleveland, OH, USA]."
15805946|NCT04401657|Diagnostic Test|Fractional flow reserve with adenosine stress testing|ECG, FFR, and two-dimensional echocardiographic monitoring will be continued before, during and after adenosine infusion.
15805947|NCT04401644|Diagnostic Test|Novel laser inferometry test for CORONA virus|detection of virus particles by light absorbtion patterns.
15805948|NCT04401631|Device|Blood Collection|"Between-Run Reproducibility K3-EDTA venous whole blood 3 mL 1 venous draw
~Operator-to-operator imprecision (abioSCOPE) K3-EDTA capillary whole blood 0.05 mL/draw; 0.15 mL total 3 finger sticks (3 different fingers)
~Sample type comparison (abioSCOPE) K3-EDTA capillary whole blood, venous serum, venous K3-EDTA plasma 0.35 mL (finger stick), 9 mL of whole blood to get a minimum of 3 mL of serum and 9 mL of whole blood K3-EDTA to get a minimum of 3 mL of plasma 1 finger stick; 1 venous draw into serum tube (9 mL) and 1 venous draw into K3-EDTA plasma tube (9 mL), in total 18 mL
~Method comparison (abioSCOPE and ImmunoCAP/Phadia) K3-EDTA capillary whole blood, venous K3-EDTA plasma 0.05 mL (finger stick), 9 mL of whole blood to get a minimum of 3 ml of plasma 1 finger stick; 1 venous draw into K3-EDTA plasma tube (9 mL tube)"
15805949|NCT04401618|Other|Retrospective evaluation of RMGI and GIC Class V Restorations|Retrospective evaluation of RMGI and GIC Class V Restorations that were placed by dental students over the last three years were evaluated using the modified USPHS criteria using mirrors and probes.
15805950|NCT04401605|Other|Fermented Food-supplemented Diet|Fermented foods include Kimchi, Sauerkraut, Yoghurt, Kefir and more.
15805951|NCT04401605|Other|Regular Diet|No change in diet.
15805952|NCT04401579|Other|Placebo|The matching Baricitinib placebo contains lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, and magnesium stearate. The coating for the placebo tablet is identical to that of the corresponding active tablet.
15805953|NCT04401579|Drug|Remdesivir|Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.
15805954|NCT04401579|Drug|Baricitinib|Baricitinib is a Janus kinase (JAK) inhibitor with the chemical name [1-(ethylsulfonyl)-3-(4-(7Hpyrrolo(2,3-d)pyrimidin-4-yl)-1H-pyrazol-1-yl)azetidin-3-yl]acetonitrile Each tablet contains 2 mg of baricitinib and the following inactive ingredients: croscarmellose sodium, magnesium stearate, mannitol, microcrystalline cellulose, ferric oxide, lecithin (soya), polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.
15805955|NCT04401566|Other|Internal myofascial release|Internal myofascial trigger point release therapy consist of 30 minutes massage directly to the pelvic floor musculature by vaginally. Patients were instructed in internal myofascial relase techniques. Experienced pelvic health physiotherapist (A.B.) to use her fingers with a lubricated glove when the finger could easily reach internal trigger points and follows these steps: (a) finding internal and external trigger points associated with pelvic muscles, especially around sensitive areas of the vagina, anus, and/or pelvic floor; (b) releasing with the fingers the trigger point associated pelvic muscle tension by carefully pressing on the trigger point
15805956|NCT04401566|Other|External myofascial release|Eksternal myofascial trigger point release therapy consist 30 minutes massage to the abdominal wall, gluteal area and adductors and hamstring muscles. Pain in trigger points may exist at both locations of muscle insertion as well as in the belly and lower extremity of the muscle.
15805957|NCT04401566|Other|Control Group|The Control group will have a paper about exercises recommended in pelvic pain for 30 minutes. A physiotherapist will teach and show the exercises for pelvic pain. The home exercise for pelvic pain contains diaphragm breating, pelvic floor muscle stretching and releasing.
15805958|NCT04401553|Drug|cephalosporin|First tier antibiotics, cephalosporin, will be given before anesthesia induction in the subjects with a history of allergy-like event to beta-lactam
15805959|NCT04401553|Drug|Second tier antibiotic (Vancomycin)|Second tier antibiotics, vancomycin, will be given before anesthesia induction for infection prevention in the subjects with a history of allergy-like event to beta-lactam (standard of care)
15805960|NCT04401527|Drug|Sodium Nitrite|Continuous intravenous infusion of Sodium Nitrite Injection
15805961|NCT04401527|Drug|Normal Saline|Continuous intravenous infusion of Normal Saline
15805962|NCT04401514|Device|Rocking chair therapy|20 min long rocking therapy with music cure. The therapy can be extended if needed
15805963|NCT04401501|Other|Manual Therapy and Exercises|Combination of physiotherapy (manual therapy) techniques and exercises for cervicogenic headache
15805964|NCT04401501|Other|Exercise|Exercises for cervicogenic headache
15805965|NCT04401488|Biological|Prevenar 7 and Prevenar 13|pneumococcal conjugate vaccines
15805966|NCT04401475|Biological|SOC plus 15mg/kg EB05 IV|Standard of care plus single IV infusion of 15mg/kg of EB05.
15805967|NCT04401475|Other|SOC plus Placebo IV|Standard of care plus a single IV infusion of placebo.
15805969|NCT04401462|Behavioral|Sling or a long-arm plaster|Non-operative treatment and progressive range of motion as tolerated. A long-arm plaster will be used, if necessary, for pain relief.
15805970|NCT04401423|Drug|TXA127|0.74 mg/kg per day
15805971|NCT04401423|Drug|Placebo|0.74 mg/kg per day
15805972|NCT04401410|Biological|Dose Finding Phase (MTD)|Enrollment to the dose escalation phase will be staggered. The first patient enrolled on each of the 3 dose levels (DL1, DL2 and DL3) will have to complete the 14-day toxicity monitoring window prior to enrollment of the next patients. Prior to dose escalation, all patients at a particular dose level should have completed the minimum 14-day toxicity monitoring window before enrolling to a higher dose level.
15805973|NCT04401410|Biological|Partially HLA-matched SARS-CoVSTs|Infusion of SARS-CoVSTs at the MTD level as determined in the Dose Finding Phase
15805974|NCT04401410|Other|Routine care (no SARS-CoVSTs)|Patients receive routine care for COVID19 per institutional standards (including antivirals such as remdesivir or other FDA-EUA approved products and thromboprophylaxis).
15805975|NCT04401397|Procedure|Intensive early mobilization techniques|"Pulmonary techniques: lung mechanics and breathing pattern restoration, mucus clearance techniques, breathing control and cough techniques.
~Musculoskeletal techniques: strengthening and functional exercises, active assistive moving techniques."
15805976|NCT04401384|Drug|Diclectin|Diclectin (combination of 10 mg doxylamine and 10 mg pyridoxine hydrochloride in a delayed release tablet) During the first two days, patients will start with an initial oral dose of 2 tablets at bedtime. If the symptoms assessed on the second day are not relieved, 3 tablets will be administered on the third day (1 tablet in the morning and 2 tablets at bedtime). On the third day if the symptoms are still not relieved, another tablet will be added in the afternoon on the fourth day (1 tablet in the morning, 1 tablet in the afternoon and 2 tablets at bedtime). Therefore, the maximum assigned dosage of Diclectin or placebo tablets do not exceed 4 tablets per day. The treatment duration will lasts for 14 days.
15805977|NCT04401384|Device|Diclectin placebo|Diclectin placebo will be packed and tested by a commercial pharmacy supply company specifically for this study. It have the same appearance, size, batch, odor, and taste compared with Diclectin. During the first two days, patients will start with an initial oral dose of 2 tablets at bedtime. If the symptoms assessed on the second day are not relieved, 3 tablets will be administered on the third day (1 tablet in the morning and 2 tablets at bedtime). On the third day if the symptoms are still not relieved, another tablet will be added in the afternoon on the fourth day (1 tablet in the morning, 1 tablet in the afternoon and 2 tablets at bedtime). Therefore, the maximum assigned dosage of placebo tablets do not exceed 4 tablets per day. The treatment duration will lasts for 14 days.
15805978|NCT04401384|Device|Active acupuncture|Participants will receive active acupuncture every day for 2 consecutive weeks, a total of 14 sessions. The needle will be left for 30 minutes. After de qi induced by acupuncture, the paired electrodes of the electroacupuncture device will be connected to the needle handle horizontally (except for PC6).
15805979|NCT04401384|Device|Sham acupuncture|Blunt-tipped placebo needles will be used. Participants will receive sham acupuncture every day for 2 consecutive weeks, a total of 14 sessions. The needle will be left for 30 minutes. After de qi induced by acupuncture, the paired electrodes of the electroacupuncture device will be connected to the needle handle horizontally (except for PC6). Then, the paired electrodes of the electroacupuncture device will be connected to the needle handle horizontally (except for PC6).
15805980|NCT04401345|Drug|Glycopyrrolate 0.2 MG/ML|In this group, the patients will receive glycopyrrolate 0.2 mg in 1 ml
15805981|NCT04401345|Drug|Normal saline|In this group, the patients will receive 1 ml of 0.9% normal saline
15805982|NCT04401332|Other|mobile health app|asthma symptom monitoring via a clinically integrated mobile health (mHealth) app installed on patients' smartphones
15805983|NCT04401319|Device|Sham Stimulation for Crossover Study|Stimulation will be delivered on the dorsolateral prefrontal cortex (DLPFC) or the angular cortex (AG) using a sham coil for 20 minutes with a frequency of 20Hz (train duration: 4s; inter-train interval: 26s; 3200 pulses at 80% of the resting motor threshold ) in one session. A single session will be conducted.
15805984|NCT04401319|Device|DLPFC Stimulation for Crossover Study|Stimulation will be delivered on the left dorsolateral prefrontal cortex (DLPFC) using a real coil for 20 minutes with a frequency of 20Hz (train duration: 4s; inter-train interval: 26s; 3200 pulses at 80% of the resting motor threshold ) in one session. A single session will be conducted.
15805985|NCT04401319|Device|AG Stimulation for Crossover Study|Stimulation will be delivered on the left angular cortex (AG) using a real coil for 20 minutes with a frequency of 20Hz (train duration: 4s; inter-train interval: 26s; 3200 pulses at 80% of the resting motor threshold ) in one session. A single session will be conducted.
15805986|NCT04401319|Device|Sham Stimulation for Parallel Study|Stimulation will be delivered on the dorsolateral prefrontal cortex (DLPFC) or the angular cortex (AG) using a sham coil for 20 minutes with a frequency of 20Hz (train duration: 4s; inter-train interval: 26s; 3200 pulses at 80% of the resting motor threshold ) in one session. Twenty sessions will be conducted.
15805987|NCT04401319|Device|DLPFC Stimulation for Parallel Study|Stimulation will be delivered on the left dorsolateral prefrontal cortex (DLPFC) using a real coil for 20 minutes with a frequency of 20Hz (train duration: 4s; inter-train interval: 26s; 3200 pulses at 80% of the resting motor threshold ) in one session. Twenty sessions will be conducted.
15805988|NCT04401319|Device|AG Stimulation for Parallel Study|Stimulation will be delivered on the left angular cortex (AG) using a real coil for 20 minutes with a frequency of 20Hz (train duration: 4s; inter-train interval: 26s; 3200 pulses at 80% of the resting motor threshold ) in one session. Twenty sessions will be conducted.
15805989|NCT04401306|Other|Home-based self-regulated simulation training (SRST)|Participants allocated to the SRST arm train basic laparoscopic skills at home. Participants train by themselves using a portable box training model (BT). Training is conducted and structured through an online application-based training platform. Training is instructed by online instructional videos and texts. The BT is connected to a laptop and the participants can submit videos of their training exercises for assessment through the online training platform.
15805990|NCT04401306|Other|Centralized instructor-regulated simulation training (IRST)|Participants allocated to the IRST arm train basic laparoscopic skills at the simulation centre. Participants train on a portable box training model (BT). Training is structured through an online application-based training platform and facilitated and instructed by surgical specialists. The BT is connected to a laptop and the participants can submit videos of their training exercises for assessment through the online training platform.
15805992|NCT04401293|Drug|Prophylactic/Intermediate Dose Enoxaparin|Prophylactic/Intermediate Dose LMWH or UFH therapy
15805996|NCT04401267|Drug|Intensive Antihypertensive Therapy|Receives intensive antihypertensive therapy
15805997|NCT04401267|Drug|Conventional Antihypertensive Therapy|Receives conventional antihypertensive therapy
15805998|NCT04401267|Other|Symptom Survey|The symptom survey is comprised of the PROMIS Ped 25 profile, PROMIS pain interference 8a, PROMIS physical activity 8a, and PROMIS mobility 8a during induction (day 23-28), during week 17 of continuation (+/- 2 weeks), and continuation week 49 (+/- 3 weeks).
15805999|NCT04401267|Other|Semi-structured interview|Patients will be interviewed by a trained examiner about their treatment and symptom burden on Week 49 of TOT17 Continuation Therapy. The interview will be recorded and will take about 30-45 minutes.
15806000|NCT04401228|Other|predict admission of covid-19 patients to ICU and death with routine and quickly avalaible clinical, biological and radiological variables?|"patients were questioned about their usual medication (Sartan, angiotensin-converting enzyme inhibitors, nonsteroidal anti-inflammatory drug, immunosuppressive drugs), their health condition (diabetes, hypertension, tobacco use, mental status). The Body mass index was computed.
~Age, gender, caucasian/african, weight, body mass index, number of days with symptoms before hospitalization, asthenia, pyrexia, dyspnea, chest pain, digestive sign, anosmia, ageusia, confusion, Travel or contact < one month, cigarette consumption ,hypertension, diabetes, mental status, angiotensin-converting-enzyme inhibitors, Sartan, non-steroidal anti-inflammatory drugs, immunosuppressive drugs, SpO2,Thoracic Computerized Tomography : % of lung injury, Thoracic Computerized Tomography : density of lung injury, blood type, white blood cells, neutrophils, lymphocytes, blood platelets, fibrinogen, ferritin, triglycerides, LDH, troponin, CRP. The dates of admission to ICU and death were recorded"
15806001|NCT04401215|Behavioral|Technology Augmented Treatment for Screening, Brief Intervention, Referral, and Treatment (SBIRT)|This group will answer to questions on the iPad at baseline visit and will receive up to 4 text messages per day asking about their Health and treatment during 30 days.
15806002|NCT04401202|Dietary Supplement|Nigella sativa oil|Nigella sativa oil 500mg softgel capsules in oral twice daily dose for 10 days
15806003|NCT04401176|Drug|Heparin & Alkalinized Lidocaine Bladder Instillation|Bladder instillation instilled via catheter and to dwell for minimum of 30 minutes prior to spontaneous void
15806004|NCT04401176|Drug|Onabotulinum Toxin A|Intradetrusor onabotulinumtoxinA injection (0.5mL x 20 sites)
15806005|NCT04401163|Diagnostic Test|Imaging of the lungs|After hospital admissions with COVID19 patients will come for two clinical visits to complete a number of questionnaires, pulmonary function testing, six-minute walk test, blood sampling and imaging of the lungs.
15806006|NCT04401150|Drug|Vitamin C|Intravenous vitamin C administered in bolus doses of 50 mg/kg mixed in a 50-ml solution of either normal saline (0.9% NaCl) or dextrose 5% in water (D5W) during 30 to 60 minutes, every 6 hours for 96 hours (i.e. 200 mg/kg/day and 16 doses in total).
15806007|NCT04401150|Drug|Control|Dextrose 5% in water of normal saline (0.9% NaCL) in a volume to match vitamin C.
15806008|NCT04401137|Drug|Topiramate|Topiramate
15806009|NCT04401124|Other|no intervention|no intervention
15806010|NCT04401085|Diagnostic Test|SARS-CoV-2 diagnostic rapid test|The rapid test detects the presence of antibodies against SARS-CoV-2 in the IgM and IgG class by the immunochromatographic reaction. It cannot detect early infection, the antibodies will probably appear two weeks after possible infection. The collection will be performed by finger puncture.
15806011|NCT04401085|Diagnostic Test|Quantitative analysis of SARS-CoV-2 antibodies|The subsample from Olomouc region (Olomouc, Uničov, Litovel) is based on venous blood sampling and archiving for subsequent quantitative analysis of SARS-CoV-2 antibodies. These tests detect immunoglobulins M and G (IgM and IgG).
15806012|NCT04401059|Drug|Elemene plus First-generation EGFR-TKIs|"Elemene Injectable Emulsion: 20ml: 88mg, 6 injections each time, once a day. 3 weeks for a course of treatment, continuous intravenous drip for 2 weeks, followed by 1-week rest. Continue to use Elemene Oral Emulsion. For specific usage, refer to the drug label.
~Elemene Oral Emulsion: 20ml: 176mg, 1 dose each time, 3 times a day. Use the Elemene Oral Emulsions until the disease progresses, the intolerable toxicity, the patient withdraws from the study, or dies for any reason.
~First-generation EGFR-TKIs: refer to the drug label."
15806013|NCT04401059|Drug|First-generation EGFR-TKIs|refer to the drug label.
15806014|NCT04401046|Other|Survey to assess Post traumatic stress and anxiety at inclusion and 6 months later|The first survey will include questions relative to sociodemographic characteristics, existence of psychological troubles; living conditions in the Covid19 pandemic context; IES-R, Stait Trait Anxiety, and the fear of a cancer recurrence scales, satisfaction with cancer care and medical status of patients (diagnosis, ongoing treatment, follow-up of the disease).
15806015|NCT04401033|Behavioral|Telephonic medical visit|The patient will receive a telephonic call passing a medical visit
15806016|NCT04401033|Procedure|Gastrointestinal endoscopy|Upper or lower GI endoscopy according to clinical practice and current guidelines
15806017|NCT04401033|Procedure|Abdominal ultrasound|Diagnostic abdominal ultrasound according to the current guidelines
15806018|NCT04401020|Drug|SAR442257|Pharmaceutical form: Sterile lyophilized powder for reconstitution Route of administration: Intravenous infusion
15806019|NCT04401007|Other|Erector Spinae Plane Block with 1.5% lidocaine|Erector spinae plane (ESP) block is a new regional nerve block technique that involves a percutaneous injection of local anesthetic as a bolus through a needle or catheter into the fascial plane between the erector spinae muscle and the transverse processes in the upper or mid back.
15806053|NCT04400825|Other|Dry needling|Dry needling of the active MTrPs following the technique described by Hong et al (1994,1995)
15806054|NCT04400812|Other|questionnaire|Arabic questionnaire focused on knowledge, perception and attitude
15806055|NCT04400799|Drug|Enoxaparin 40Mg/0.4Ml Inj Syringe 0.4Ml|daily incetion s.c. for 14 days
15806259|NCT04399070|Drug|saline|The depression patients received propofol and saline before ECT
15806020|NCT04400994|Drug|Rituximab|"Rituximab would be given intravenously.
~IV Rituximab is prediluted at a dose of 500mg in 500ml of 0.9% normal saline (i.e. 1:1 dilution, 1 mg/ml)
~Initial infusion rate starts at a rate of 50mg/hr (50ml/hr)
~If no hypersensitivity/anaphylaxis reaction occurs, increase infusion rate in 50mg/hr (50 ml/hr) increments every 30 minutes
~Maximum infusion rate is 400 mg/hr (400 ml/hr)
~Subsequent infusion: start at rate of 100mg/hr (100 ml/hr), increase 100mg/hr (100 ml/hr) increments every 30 minutes
~Monitor temperature, BP HR, respiratory rate and SpO2 every 30 minutes"
15806021|NCT04400994|Other|IVIg|"IVIg would be given in combination with Rituximab intravenously. Infusion plan of IVIg:
~0 min: 50ml/hour 15 min: 75ml/hour 30 min: 100ml/hour 45 min: 125ml/hour 60 min: 150ml/hour 75 min & beyond: 180ml/hour"
15806022|NCT04400981|Procedure|Remote ischemic conditioning|Remote ischemic conditioning will be applied immediately after randomization in the Emergency Department, through a standard blood pressure cuff placed around the non-paretic arm. The protocol includes 4 cycles of intermittent manually induced upper limb ischemia, alternating 5 minutes of inflation (20mmHg above systolic blood pressure) and 5 minutes of deflation.
15806023|NCT04400981|Other|standard medical therapy|"Standard medical therapy comprises single antiplatelet therapy, either aspirin given in a total dose ranging between 100 to 300 mg per day on days 1-5 and followed by aspirin 100mg/day on days 1-5 followed by aspirin 100mg/day, or Clopidogrel 75mg/day (at the discretion of the patient's attending physician), unless an indication for early anticoagulation (e.g. atrial fibrillation, mechanical heart valve, deep venous thrombosis, pulmonary embolism, antiphospholipid antibody syndrome, hypercoagulable state) or dual antiplatelet therapy (e.g. early carotid stenting) is present.
~All patients will receive standard deep venous thrombosis (DVT) prevention therapy together with appropriate treatment for blood pressure control, glycemic control and cholesterol reduction."
15806024|NCT04400968|Procedure|Auricular therapy|The auricular therapy points were selected following the protocol for dysmenorrhoea described by Oleson (Oleson, 2008). These points were (the name of the European cartography is specified by the name of the point): Shenmen [FT2], uterus [FT5], sympathetic [HI4], kidney [CS6], heart [CI4], endocrine [IT2] and thalamus [PC2].
15806025|NCT04400968|Procedure|kinesio tape|Before the tape application, the skin surface was removed of hair when needed and cleansed. The tapes were applied at 25% of tension and were placed horizontally covering the area between the antero-superior iliac spines and the postero-superior iliac spines and vertically from the navel to the symphysis pubis. All bandages were adhered to the skin with a technique type I with a space augmentation. The centre of the tape was removed and applied at 25% of tension. Afterwards, the rest of the protector were removed and the laterals anchors of the tape were adhered with no tension. The participant maintained a slight extension of the trunk while the tape was applied on the anterior aspect of the truck and a slight flexion while the tape was applied in the posterior aspect of the trunk.
15806026|NCT04400968|Procedure|Auricular therapy Placebo group|Sham auricular therapy
15806027|NCT04400968|Procedure|kinesio tape Placebo group|Sham kinesio tape
15806028|NCT04400955|Diagnostic Test|Audiometry tablet diagnostic tool and web-based test|as above
15806029|NCT04400942|Diagnostic Test|Transvaginal ultrasound|Transvaginal ultrasonographic scan aims to evaluate number, size (diameter and volume), location and appearance of submucous uterine myomas, concomitant presence of adenomyosis
15806030|NCT04400942|Behavioral|Anamnesis|Anamnesis aims to collect data about age, BMI, previous hormonal therapies (such as ulipristal acetate or gonadotropin-releasing hormone agonists) with submucous uterine myomas
15806031|NCT04400942|Procedure|Operative hysteroscopy|Operative hysteroscopy allows a direct evaluation of number, size (diameter and volume), location and appearance of submucous uterine myomas. This exam allows the resection of the myomas.
15806032|NCT04400929|Drug|Sargramostim|Dosage for IV Leukine® injection: 125mcg/m2/day over a 4-hour period for up to 5 days.
15806033|NCT04400929|Other|Normal Saline 0.9%|IV normal saline 0.9% for 5 days
15806034|NCT04400916|Drug|Tranexamic acid|A single drop administered topically
15806035|NCT04400916|Other|Balanced Salt Solution|A single drop administered topically
15806036|NCT04400903|Device|Activity Monitor|Undergo HRV monitoring via WHOOP device
15806037|NCT04400903|Other|Quality-of-Life Assessment|Ancillary studies
15806038|NCT04400903|Other|Questionnaire Administration|Complete questionnaires
15806039|NCT04400890|Drug|Resveratrol|Resveratrol vs placebo given for 15 days.
15806040|NCT04400890|Dietary Supplement|Vitamin D3|Vitamin D3 100,000 IU given on day one.
15806041|NCT04400877|Diagnostic Test|Diagnostic examination for venous thromboembolism|Patients who have done a diagnostic examination for suspected VTE (pulmonary embolism och deep venous thrombosis) within the health care system of Region Östergötland. Patients without matching diagnostic examination but with a new diagnosis of pulmonary embolism or deep venous thrombosis during the same time periods will also be taking into account.
15806042|NCT04400864|Other|Dietary intervention|dietary counseling based on the principals pf the dietary intervention group.
15806043|NCT04400851|Drug|Sintilimab|Patients were enrolled by the design of phase I study standard. Sintilimab was divided into three dosage levels: 1 mg / kg, 3 mg / kg, and 10 mg / kg. The first level of sintilimab was followed by dose escalation
15806056|NCT04400786|Procedure|intermittent treatment|According to the feeling of pain, the on-demand treatment group is prescribed with or without Imrecoxib (100mg/tablet, 100mg.prn.po), but the maximal dose does not exceed 100 mg per time, twice (morning and evening) per day. The duration lasted for 24 weeks.
15806057|NCT04400786|Procedure|continuous treatment|The continuous treatment group is prescribed Imrecoxib (100mg.bid.po) regardless of the pain in the treatment course for 24 weeks.
15806058|NCT04400773|Other|Plyometric exercises|Types of exercises include resistance tubing 90-90 external rotation, plyometric push-up, reverse overhead throws, rotational wall throw, overhead medicine ball, chest passes.
15806059|NCT04400773|Other|Strength training exercises|Types of exercise include push-ups, resisted external rotation, overhead presses, biceps curl, bench presses and triceps kick backs.
15806060|NCT04400760|Drug|DAPA Tx|The intervention, dapagliflozin will be administered 10mg per oral daily for two weeks.
15806061|NCT04400747|Drug|Vitamin D3|one group will take weekly oral 50000 IU Vitamin D3, other group will take daily oral 6000 IU Vitamin D3.
15806062|NCT04400734|Other|No intervention, observational study|no intervention
15806063|NCT04400721|Drug|Erector spinae plane block with ropivacaine 3.75mg/ml|Single shot erector spinae block
15806064|NCT04400708|Procedure|adductor canal block|After the end of the surgery, at the arrival of PACU, the patient's leg is prepared and draped in a sterile manner. Assisted by the high-frequency linear ultrasound transducer, we target the mid-thigh level and the 22-gauge/8cm needle is introduced in plain through the sartorius muscle. the correct position for the tip of the needle in the adductor canal is checked and a bolus injection of 0.5% ropivacaine 15ml is given.
15806065|NCT04400708|Procedure|control group|After the end of the surgery, at the arrival of PACU, the patient's leg is prepared and draped in a sterile manner. Assisted by the high-frequency linear ultrasound transducer, we target the mid-thigh level and the 22-gauge/8cm needle is introduced in plain through the sartorius muscle. the correct position for the tip of the needle in the adductor canal is checked and a bolus injection of normal saline15ml is given.
15806066|NCT04400695|Drug|RC48-ADC|RC48-ADC 2.0mg / kg, intravenous drip, once every 2 weeks
15806067|NCT04400695|Drug|Paclitaxel Injection|Administered according to label, as one option for Physician's Choice (determined before randomization)
15806068|NCT04400695|Drug|Docetaxel Injection|Administered according to label, as one option for Physician's Choice (determined before randomization)
15806069|NCT04400695|Drug|Vinorelbine Tartrate Injection|Administered according to label, as one option for Physician's Choice (determined before randomization)
15806070|NCT04400695|Drug|Capecitabine Tablets|Administered according to label, as one option for Physician's Choice (determined before randomization)
15806071|NCT04400682|Drug|FAVIRA 200 MG Film Tablet|FAVIRA is containing 200 mg favipiravir manufactured by Novelfarma, Turkey.
15806072|NCT04400682|Drug|AVIGAN 200 MG Film Tablets|AVIGAN is containing 200 mg favipiravir manufactured by Toyama, Japan
15806073|NCT04400669|Other|Mechanical Bowel Preparation|oral sodium phosphate (NaP) enema
15806074|NCT04400669|Dietary Supplement|Low fibre diet|3 days
15806075|NCT04400669|Other|MBP plus low-fibre diet|3 days low fibre diet preoperative mechanical bowel preparation
15806076|NCT04400630|Other|Physical exercise|The experimental group will receive supervised physical exercise treatment by high-intensity interval training (HIT), alternating high and moderate intensities (20 min). The participants will exercise two non-consecutive days per week for 16 weeks under supervision by exercise specialists.
15806077|NCT04400617|Behavioral|Cross-sectional assessments to examine the relationship among sleep quality, functional/physical capacity, and cognitive performance.|The first visit will consist of screening measurements. Participants will be asked to complete the following questionnaires: InterRAI Self Report Quality of Life Survey for Long Term Care Facilities (interRAI SQoL), Resident Assessment Instrument (RAI)-MDS 2.0, Global Physical Activity Questionnaire (GPAQ), Memory Complaint Questionnaire (MAC-Q), and Pittsburgh Sleep Quality Index (PSQI). At the end of this visit, the participants will be asked to wear the ActiWatch-2 (AW-2) as a wristwatch for 14 days. In the second visit, participants' height and weight will be measured and the participants will perform the following cognitive and functional tests: MoCA, Brief Visuospatial Memory Test-Revised (BVMT-R), Hopkins Verbal Learning Test-Revised (HVLT-R), Time up and Go (TUG), and Cognitive TUG (TUGcog). Finally, visit 3 will consist of on-site PSG recordings.
15806078|NCT04400591|Biological|Nonconforming Lisocabtagene Maraleucel|Nonconforming lisocabtagene maraleucel is lisocabtagene maraleucel that does not meet the commercial release specifications, however is deemed acceptable to administer as an investigational product in the Expanded Access Protocol setting.
15806079|NCT04400578|Device|Trichloroacetic acid 85% (TCA)|Purpose and scope of Medical Device: Treatment and relief of a disease. Application to cervical intraepithelial neoplasia with a cotton swab.TCA is an investigational device intended to achieve a complete histologic remission in individuals with cervical intraepithelial neoplasia (CIN) grade 1/2.
15806080|NCT04400565|Behavioral|Recovery group|The researchers designed a recovery group suited to Taiwanese with mental illness, according to content of the Pathways to Recovery (PTR): A Strengths Recovery Self-Help Workbook (Ridgway et al., 2002) and recovery-related literature (Davidson et al., 2005; Ridgway, 2001)
15806081|NCT04400552|Dietary Supplement|ONS Pre-op + ONS Post-op|Participants will consume the oral nutrition supplementation (ONS) in addition to normal diet for 14 days pre-operatively and post-operatively up to participants being discharged from the hospital.
15806082|NCT04400552|Dietary Supplement|ONS Pre-op + ONS Post-op + ONS Post-op 3 months|Participants will consume the oral nutrition supplementation (ONS) in addition to normal diet for 14 days pre-operatively, post-operatively up to participants being discharged from the hospital and an extended oral nutrition supplementation post-operatively up to 3 months.
15806083|NCT04400552|Dietary Supplement|Usual intake Pre-op + ONS Post-op|Participants will follow a meal plan of 2000 kcal / day using conventional foods for 14 days pre-operatively and consume oral nutrition supplementation (ONS) in addition to normal diet post-operatively up to participants being discharged from the hospital
15806102|NCT04400383|Drug|AB011 Injection|AB011 Injection with dose escalation stage of 1mg/kg up to 40mg/kg, as well as dose expansion stage with recommended dose level from dose escalation stage.
15806103|NCT04400370|Device|Diaphragm ultrasound|"Diaphragm ultrasound is performed at the following three time points.
~At the entrance of the operating room before induction of anesthesia
~1 hour after surgery
~24 hours after surgery"
15806084|NCT04400539|Device|intrapleural photodynamic therapy with videothoracoscopy|MPM patients will be first administrated 20 mg/kg of oral photosensitizer, 5-Aminolevulinic Acid (5-ALA) {Gliolan®}, 4 to 6 hours prior undergoing thoracoscopy (VATS). During VATS procedure, after a qualitative control of the fluorescence of tumor lesions and some guided pleural tumor biopsies, the pleural cavity will be illuminated using a flexible probe and laser source at a specific wavelength for 5-ALA (400-500 nm; 25 J/cm2) during 15 minutes (6 fractions of 2.5 minutes separated by 5 pauses of 2 minutes each to improve tissue oxygenation for the PDT reaction). An IPC device (but no talc) will be inserted and used for pleurodesis and may permit to collect further pleural effusion samples. As 5-ALA has a short half-life and thus does not need extensive precautions to avoid patient photosensitivity, the patient would not stay longer than a standard procedure (about 2-3 days in the hospital)
15806085|NCT04400539|Drug|Nivolumab Injection|Seven to 10 days after VATS, patients will start to be treated by Nivolumab 240mg IV every 2 weeks till progression (CT-scan reassessment every 8 cycles), unacceptable toxicity, or maximum 2 years.
15806086|NCT04400526|Behavioral|A video competition|Each Individual/group will be required to produce a maximum of 2-minute video on one of the following themes: (1) the hazardous effects of drug especially less psychotropic drugs such as Cannabis, (2) encouraging messages to drug abusers, and (3) existing anti-drug services.
15806087|NCT04400526|Behavioral|A training workshop|The workshop will last for 6 hours, and will be delivered by an experienced counsellor from C.H.O.I.C.E. The content of the workshop will include (1) hazardous effects of drug abuse especially less psychotropic drugs such as Cannabis, (2) signs and symptoms of drug abuse particularly less psychotropic drugs like Cannabis, (3) alternatives to drug abuse, (4) community resources available, and (5) how to refer drug abusers. Besides, all children will be taught to use the AWARD model for referrals in the workshop.
15806088|NCT04400526|Behavioral|A mass promotional campaign|Children who complete the training workshop in phase 2 will be invited to join phase 3. They are encouraged to design their own promotional activities for community members in the targeted districts. The activities can be delivered by a group (a maximum of 5 ADAs per group) or by an individual. Types of activities can include but not limited to health talks, booths, outreaching activities, games, posters, leaflets and websites. Likewise, if the ADAs encounter any drug abuser in their social circles, the ADAs will be asked to deliver a brief advice based on the AWARD model.
15806089|NCT04400513|Device|Use of Eko CORE and Eko DUO electronic stethoscopes|Auscultation of heart sounds using electronic stethoscopes
15806090|NCT04400500|Diagnostic Test|Approaches to differential diagnosis and risk stratification|Detailed analysis of clinical course, ECG, biomarkers (hsTn I, CK-MB mass, myoglobin, NT-proBNP, hsCPR, cardiac FABP on admission and after 3 hours; hsTn I, CK-MB mass and myoglobin after 6 hours if needed) as well as HEART, ADAPT, EDACS, T-MACS, GRACE, ACTION and TIMI scores.
15806091|NCT04400487|Drug|Voxelotor|500 mg Tablet, Oral, With or Without Food
15806092|NCT04400474|Drug|Cabozantinib 40 mg|All the subjects will be treated with the combination of cabozantinib and atezolizumab until disease progression, unacceptable toxicity or patient consent withdrawal (whichever occurs first).
15806093|NCT04400461|Other|Data collection and clinical testing of subjects|"Clinical Testing: muscle strength. Muscle strength, as a component of physical function, will be assessed with the Medical Research Council sum score (MRC- SS) at discharge from the ICU and at discharge from the hospital.
~Clinical testing: physical function. The Functional Status Score for the ICU (FSS-ICU) will be used to evaluate 5 functional tasks at discharge from hospital."
15806094|NCT04400435|Device|Use of Eko DUO electronic stethoscope|Auscultation of heart sounds using electronic stethoscope
15806095|NCT04400422|Dietary Supplement|Lipano formula|Subjects will be asked to take an MCT infant formula to assess the tolerability, compliance and overall acceptability of the product for patient with LCHAD
15806096|NCT04400409|Other|Intervention A - Vascular Care + site 6MWT administration|Implementation of multiple strategies related to improving lipid management, starting with a referral to the vascular care team. The subject will undergo a visit with a vascular care team, including a Vascular Medicine specialist who will obtain a patient history and prescribe a lipid lowering therapy regimen. The subject will also meet with a pharmacist to answer questions related to access to medications, drug side effects, and potential interactions with the subject's other medications. Additionally, the site staff will conduct and guide the subjects through 6MWTs at protocol-dictated time points.
15806097|NCT04400409|Other|Intervention B - Standard Care + site 6MWT administration|Consists of provision of the treating provider with a copy of the 2018 ACC/AHA Guidelines on the Management of Blood Cholesterol. Subjects will return at 6 and 12 months for lab draws and endpoint event assessments but will not meet with vascular care team. Additionally, the site staff will conduct and guide the subjects through 6MWTs at protocol-dictated time points.
15806098|NCT04400409|Other|Intervention A - Vascular Care + CPC EQuIP 6MWT administration|Implementation of multiple strategies related to improving lipid management, starting with a referral to the vascular care team. The subject will undergo a visit with a vascular care team, including a Vascular Medicine specialist who will obtain a patient history and prescribe a lipid lowering therapy regimen. The subject will also meet with a pharmacist to answer questions related to access to medications, drug side effects, and potential interactions with the subject's other medications. Additionally, the CPC EQuIP team will conduct and guide the subjects through 6MWTs at protocol-dictated time points.
15806099|NCT04400409|Other|Intervention B - Standard Care + CPC EQuIP 6MWT administration|Consists of provision of the treating provider with a copy of the 2018 ACC/AHA Guidelines on the Management of Blood Cholesterol. Subjects will return at 6 and 12 months for lab draws and endpoint event assessments but will not meet with vascular care team. Additionally, the CPC EQuIP team will conduct and guide the subjects through 6MWTs at protocol-dictated time points.
15806100|NCT04400396|Dietary Supplement|standard HM fortification|Based on the assumed energy and macronutrient composition of HM, the commercial multi-component HM fortifier was added, in order to compensate identified nutritional deficits.
15806101|NCT04400396|Dietary Supplement|target HM fortification|Based on the measured energy and macronutrient composition of HM, modular protein and fat supplements are added, in addition to the commercial multi-component HM fortifier, in order to correct identified specific nutritional deficits. For this purpose, an Excel program to calculate modular protein and fat supplements to be added to fortified HM was developed and registered (Nona R, Cardoso M, Portuguese Directorate of Intellectual Property Services, IGAC-DSPI, nº 480/2020, 26 February 2020)
15806104|NCT04400357|Procedure|Robotic pancreaticoduodenectomy|Patients in this arm will undergo a pancreaticoduodenectomy with robotic-assisted techonology.
15806105|NCT04400357|Procedure|Open pancreaticoduodenectomy|Patients in this arm will undergo an open pancreaticoduodenectomy which is the standard surgical approach.
15806106|NCT04400344|Other|No intervention|No intervention
15806107|NCT04400331|Drug|Valbenazine|vesicular monoamine transporter 2 (VMAT2) inhibitor
15806108|NCT04400318|Drug|Dupilumab SAR231893|Pharmaceutical form:solution for injection Route of administration: subcutaneous
15806109|NCT04400318|Drug|Placebo|Pharmaceutical form:solution for injection Route of administration: subcutaneous
15806111|NCT04400292|Other|Injection of indocyanine green (ICG)dye|Patients will receive a perilesional injection of indocyanine green (ICG) before the laparoscopic phase of the esophagectomy.
15806112|NCT04400292|Device|Near-Infrared Image-Guided|Real-time near-infrared (NIR) fluorescence imaging will be performed by use of the Novadaq PINPOINT minimally invasive system with a laparoscopic camera.
15806113|NCT04400292|Procedure|Sentinel Lymph Node (SLN) mapping|Any identified SLNs will be dissected during the standard completion lymphadenectomy and esophagectomy.
15806114|NCT04400279|Behavioral|Yoga group|At-home yoga exercise instruction provided by a mobile/tablet app or through a computer web browser
15806115|NCT04400279|Behavioral|High Intensity Interval Training group|At-home HIIT exercise instruction provided by a mobile/tablet app or through a computer web browser
15806116|NCT04400279|Behavioral|Combination|At-home yoga & HIIT exercise instruction provided by a mobile/tablet app or through a computer web browser
15806117|NCT04400266|Drug|B+MEL|Buspirone and Melatonin
15806118|NCT04400253|Behavioral|SAATH Intervention|SAATH intervention is a physical activity intervention for South Asian mothers and daughters with group exercise classes and discussion groups.
15806119|NCT04400240|Behavioral|CALLS|The CALLS program will consist of 12 weeks of service delivery that will include one standard educational session by telephone or in-person meeting every week. The weekly educational session will be generally structured in three parts: introduction, structured education, and problem solving. Weekly content will be adapted from the twelve modules of the Peer Approaches to Lupus Self-management (PALS) study, and further tailored according to prominent barriers to care in the scientific literature. Content will include: 1) Medication adherence; 2) Communication with provider; 3) Patient engagement; 4) Recognizing and treating depression; 5) Overcoming socioeconomic barriers; 6) Social Support network; 7) Appointment/ Lab adherence; and 8) Transportation.
15806120|NCT04400227|Other|Family Talk|"Family Talk is an evidence-based, parent-youth dyadic approach that uses psychoeducation and skills building to help families make meaning of a parent's adversity, increase resilience, and improve family functioning.
~The Family Talk model comprises two components: the first involves a series of cognitive-behavioral techniques to bolster problem solving and communication skills among family members; the second involves a facilitated family meeting to develop a shared narrative for discussing each family member's experience of the parent's illness."
15806121|NCT04400214|Behavioral|Food Allergy Superheroes Training (FAST) Program|The primary aim of the FAST intervention is to 1) increase the young child's understanding of food allergies (FA) and 2) promote-adherence to FA safety guidelines through active skills training. We will achieve this aim through the use of educational materials (session 1) and a developmentally-tailored skills training intervention (session 2-5). Core components embedded within each skill straining session include instructions, modeling, rehearsal, and reinforcement/corrective feedback. The young child and their parent/caregiver will be present for the entirety of all sessions; however, all intervention materials (i.e., educational content, skills training components) are designed with the young child as the primary focal point of interest. All children will be rewarded with a small toy (<$5 value) at the end of each successfully completed session.
15806122|NCT04400214|Other|Food Allergy Knowledge Intervention|"The primary aim of the FAK intervention is to increase the young child's understanding of FAs including prevalence, symptoms, and management strategies among other topics. We will achieve this aim through the use of educational materials targeting knowledge acquisition through a variety of didactic materials made freely available through the Food Allergy Research Education (FARE) website (www.foodallergy.org). More specifically, we will employ information embedded within the Food Allergy 101 segment of the FARE website. The young child and their parent/caregiver will be present for the entirety of all sessions; however, all intervention materials are designed with the young child as the primary focal point of interest. All children will be rewarded with a small toy (<$5 value) at the end of each successfully completed session. All FAK sessions will occur within the child's home and will include informational handouts relevant to the day's session."
15806123|NCT04400201|Drug|Remimazolam Tosilate|Intravenous injection at a dose of 0.3mg/kg for sedation induction and continuous intravenous infusion at an initiative dose of 1 mg/kg/h for sedation maintenance.
15806124|NCT04400201|Drug|Propofol|Intravenous injection at a dose of 1.5~2.5mg/kg for sedation induction and continuous intravenous infusion at the dose of 0~12 mg/kg/h for sedation maintenance
15806125|NCT04400188|Drug|Fluzoparib|Given PO
15806126|NCT04400188|Drug|temozolomide|Given PO
15806127|NCT04400188|Biological|SHR-1316|Given injection
15806128|NCT04400175|Device|Valved ergonomic teat|Administration of milk with a feeding system with a valved ergonomic teat in late preterm newborns.
15806129|NCT04400175|Device|Standard silicon teat|Administration of milk with a feeding system with a standard silicon teat
15806130|NCT04400162|Behavioral|Usability of the CCT|Evaluation of the usability of the provided training.
15806131|NCT04400162|Behavioral|Changes in regards to the depressive disorder|Evaluation of depressive symptoms and whether they change in regards to the provided training.
15806191|NCT04399616|Other|Risk Map|The tool we test in this project (the visual hazard map) aims to enable the practitioner to quickly identify critical areas for systematically implementing relevant safe practices (appropriate for each situation).
15806132|NCT04400149|Diagnostic Test|amniocentesis|amniocentesis will be performed to the pregnant women at 16-20 weeks who had a high-risk antenatal test. Furthermore, these women also give a blood sample (at 16-20 weeks) to compare the amniotic fluid and serum progesterone levels in association with pregnancy outcomes. We perform amniocentesis to evaluate genetic disorders in pregnant women who had his risk in the antenal test.
15806133|NCT04400136|Drug|Lansoprazole oral tablets 30 mg|Post operative prescription
15806135|NCT04400110|Drug|Amoxicillin and Clavulanic Acid in Oral Dose Form|50 mg/kg three times daily administered orally
15806136|NCT04400097|Procedure|suture|suture methods of autograft conjunctival transplantation
15806137|NCT04400084|Other|Placenta perfusion|Placenta perfusion in double closed circuit, during 3 hours
15806138|NCT04400071|Behavioral|Active Music Engagement|Weekly 45-minute sessions with a board-certified music therapist delivered during weekly clinic visits for the consolidation phase of ALL treatment. Children with standard risk ALL will receive 4 sessions over 4 weeks. Children with high risk ALL will receive 8 sessions over 8 weeks. Sessions are delivered in a private setting during regularly scheduled clinic appointments. During the first visit, parent and child will receive information on how they can use music play activities to help manage distress during treatment. The music therapist will lead parent and child in a variety of music play activities. Parent and child will receive a music kit that includes items such as hand-held rhythm instruments, puppets, and a music CD. During subsequent visits the music therapist will lead parent and child through the music play activities, answer questions, and make suggestions for using these activities in the hospital and at home.
15806139|NCT04400071|Behavioral|Audio Storybooks|Weekly 45-minute sessions with a trained provider delivered during weekly clinic visits for the consolidation phase of ALL treatment. Children with standard risk ALL will receive 4 sessions over 4 weeks. Children with high risk ALL will receive 8 sessions over 8 weeks. Sessions are delivered in a private setting during regularly scheduled clinic appointments. Each session children/parents will choose and listen to one of three illustrated children's books with audio-recorded narration.
15806142|NCT04400045|Drug|Treosulfan|Treosulfan 21mg/m2 (days -6, -5, -4)
15806143|NCT04400032|Biological|Mesenchymal Stromal Cells|The Mesenchymal Stromal Cells will be administered intravenously
15806144|NCT04400019|Drug|Hydroxychloroquine Only Product in Oral Dose Form|The dose to be used as chemoprophylaxis will be 800mg of HCQ on the first day and 400mg for the following four days.
15806145|NCT04399993|Other|Intervention Protocol in Diaphragm|"The protocol consists of three techniques. The two first techniques will be applied for 10 respiratory cycles.
~Muscle Stretching Technique:
~the researcher will perform a cephalic traction on the inferior costal border with the ulnar border during the inspiratory phase.
~Phrenic-center inhibition technique:
~the researcher, with a hand on the sternum to caudal and other hand on the umbilical region to cranial, will approach his hands on the horizontal plane, when the volunteer exales.
~Functional diaphragm technique:
~the researcher will perform a vertical pressure on the diaphragm for 5 minutes and will search for the facilitated parameters and maintain them until the release of all the periarticular elements."
15806146|NCT04399993|Other|Sham technique|In the sham group a manual contact without any therapeutic intention will be performed, in a distant region of the diaphragm (for example on the trapezius muscle). This contact will be maintained during the same amount of time as for the treatment group.
15806147|NCT04399980|Drug|Mavrilimumab|Treatment infusion
15806148|NCT04399980|Drug|Placebos|Placebo infusion
15806149|NCT04399967|Behavioral|Chat-based support|Participants will receive three months of chat-based support through IM apps (e.g. WhatsApp, WeChat). The regular messages and instant messaging on psychosocial support aim to provide hygienic advice to reduce the risk of exposure to SARS-cov2, increase self-efficacy and confidence, social support and behavioral capacity of quitting, and improve mental health during COVID-19 isolation or quarantine.
15806150|NCT04399967|Behavioral|AWARD plus COVID-specific advice|Ask about smoking history, Warn about the risks associated with the COVID-19 and smoking (with a COVID-related health warning leaflet), Advise to quit as soon as possible during the COVID-19 pandemic, Refer smokers to SC services (with a referral card, see below for information), and Do it again: to repeat the intervention
15806151|NCT04399967|Behavioral|AWARD advice|Ask about smoking history, Warn about the high risk of smoking, Advise to quit as soon as possible, Refer to the smoking cessation services, and Do it again (if the smokers refused to set quit date).
15806152|NCT04399967|Behavioral|COVID-19 related health warning leaflet|The 2-sided color printed A4 leaflet, which covers the risk of COVID-19 and smoking; hygienic advice related to COVID-19, and the most important messages to motivate smoking cessation
15806153|NCT04399967|Behavioral|Health warning leaflet|The 2-sided color printed A4 leaflet, which systematically covers the most important messages to motivate smoking cessation.
15806154|NCT04399967|Behavioral|SMS-based support|Participants will receive regular SMS with similar frequency to Intervention group but with generic information on smoking cessation.
15806155|NCT04399967|Behavioral|Referral card|"The 3-folded Smoking Cessation Services card consists of brief information and highlights of existing smoking cessation services, contact methods, motivation information and strong supporting messages or slogans."
15806156|NCT04399967|Behavioral|COSH Self-help smoking cessation booklet|A general smoking cessation self-help booklet
15806157|NCT04399954|Dietary Supplement|Ketoflo|Ketoflo is a ready to use liquid feed for the dietary management of epilepsy and other conditions that may require a ketogenic diet. It has a 4:1 ratio of fat to carbohydrate and protein and can be administered enterally via a tube feeding or oral consumption.
15806192|NCT04399603|Other|no intervention-mechanistic study|no intervention-mechanistic study
15806158|NCT04399941|Diagnostic Test|Venography|The venography will be performed as part of the patient's standard of care. The dialysis access will be punctured upstream of the arteriovenous anastomosis in AVF or AVG using a 4-F coaxial access set (Micro- puncture; Cook, Inc, Bloomington, Indiana). The contrast will be injected intravenously by a pump with 200 psi and a bolus of 2m/sec for total of 5 ml during upper extremity vein filming and 10 ml of contrast bolus by 3 ml/s during central vein filming while holding the breath in inspiration in anterioposterior plane.
15806159|NCT04399941|Diagnostic Test|Intravascular ultrasound (IVUS)|IVUS will be performed through the same sheath of the coaxial access set using an Eagle Eye Platinum RX digital catheter 7F over a compatible guidewire under fluoroscopic guidance. The lesion will be estimated fluoroscopically from the marker IVUS catheter in the vein and the cranial and caudal margins of stenotic lesion will be directly visualized during pullback of the IVUS catheter.
15806160|NCT04399941|Other|Image processing|Image processing will be performed by two radiologists in a blinded manner on the images devoid of personal identifier. An adjudication committee will oversee the process and confirm their findings in case of a discrepancy.
15806161|NCT04399928|Device|Total Hip Arthroplasty|Total hip arthroplasty with the R3 Acetabular Hip system.
15806162|NCT04399902|Device|Thermal Blanket|Ready-Heat 6-Panel Blanket (Military style, manufactured by Techtrade LLC). The 6-panel military-style blanket (86cm x 152 cm, 1.13kg) warms to 40˚C in approximately 15-20 minutes and maintains this temperature for 10 hours.
15806165|NCT04399876|Combination Product|Microdevice|"Surgery Cohort: Placement of 1-6 microdevices: Drugs chosen have all been FDA approved for the treatment of cancer (so therefore safe) and there are phase 2 or 3 data that the drug has efficacy in prostate cancer. Agents of interest included Abiraterone, Enzalutamide, Pembrolizumab, Ipilimumab, Carboplatin, Docetaxel, and Olaparib as well as combinations
~Ex vivo Cohort: Placement of multiple microdevices with miniature drug reservoirs but no drug is loaded into the removed prostate"
15806167|NCT04399850|Other|Hypnosis group|Patients who receive hypnosis
15806170|NCT04399824|Radiation|High-Dose Rate Brachytherapy|Undergo HDR brachytherapy
15806171|NCT04399824|Other|Quality-of-Life Assessment|Ancillary studies
15806172|NCT04399824|Other|Questionnaire Administration|Ancillary studies
15806173|NCT04399824|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15806174|NCT04399811|Diagnostic Test|Near-infrared Vision Photograph|The near-infrared image will be recorded (by a infrared camera connected to a laptop) for each enrolled patient
15806175|NCT04399798|Drug|Baricitinib|4 mg/day for 7 days
15806176|NCT04399785|Other|Camrelizumab and SBRT|Camrelizumab: 200mg every 3 weeks; SBRT
15806177|NCT04399772|Behavioral|Cognitive Functional Therapy+ pathway|"The CFT+ intervention comprises 4 main components: (1) making sense of pain: context-based patient education focusing on the multidimensional nature of pain and disability, while reducing the threat of structural damage and correcting unhelpful beliefs; (2) exposure with control: graded exposure to painful, feared, or avoided activities with body relaxation; (3) lifestyle changes: encouraged to perform physical activity based on preference and taught strategies to manage stress and poor sleep, (4) focus on coping strategies in life and how these strategies influence the current situation.
~After CFT+, patients can be offered the comparator pathway should that be clinically indicated from these criteria: the patient does not feel ready to stop treatment AND Analgesic treatment is inappropriate OR Social situation is problematic OR Significantly psychological distress that requires further treatment by psychologist. This decision is based on a multidisciplinary team conference."
15806178|NCT04399772|Behavioral|Interdisciplinary pain management pathway|"Treatment at the Interdisciplinary University Pain Center are based on elements from cognitive-behavioral therapy, Acceptance and Commitment Therapy, and Mindfulness-Based Stress Reduction programs.
~Individualized combination of (1) medical treatment with a specialist pain consultant+specialist pain nurse (ie, individual adjustment of analgesics to improve effect and reduce side effects), (2) one or more of the following: individual consultations with a specialist pain psychologist, physiotherapist or social worker with cognitive-behavioral therapy training as well as participation in a group program with relaxation therapy, acceptance and commitment therapy or standardized mindfulness-based stress reduction programs."
15806179|NCT04399759|Behavioral|Approach-Instrumental Activities of Daily Living|Individualized instrumental activities of daily living training
15806180|NCT04399759|Behavioral|Home health education|Individualized home health education
15806181|NCT04399746|Drug|Ivermectin|6mg once daily in day 0,1,7 and 8
15806182|NCT04399746|Drug|Azithromycin|500mg once daily for 4 days
15806183|NCT04399746|Drug|Cholecalciferol|400 IU twice daily for 30 days
15806184|NCT04399720|Procedure|Root canal treatment|Root canal treatment using a standard manual k file instrumentation and carrier-based root canal filling technique
15806185|NCT04399707|Device|Transcutaneous electrical nerve stimulation (TENS) unit|Patients will be randomized to active TENS unit, placebo TENS unit, or no TENS unit
15806186|NCT04399707|Device|Placebo transcutaneous electrical nerve stimulation (TENS) unit|Patients will be randomized to active TENS unit, placebo TENS unit, or no TENS unit
15806187|NCT04399681|Device|Bedside lung ultrasound|Point of care ultrasound will be used as bedside lung ultrasound to determine the patients if they have a COVID-19 pneumonia.
15806188|NCT04399642|Procedure|Arthroplasty|All patients include in the study will undergo a lowerlimb arthroplasty, primary or revision
15806189|NCT04399629|Behavioral|PCIT-ED|12 sessions of PCIT-ED therapy
15806190|NCT04399629|Behavioral|Parenting Wisely|Teaches parents how to set more effective limits
15806194|NCT04399577|Biological|Candida antigen|Patient receive candida antigen immunotherapy and blood samples will be withdrawn before and after intervention
15806195|NCT04399564|Device|temporary hemodialysis catheters|Vascular access using temporary vs.long-term hemodialysis catheters
15806196|NCT04399564|Device|long-term hemodialysis catheters|long-term hemodialysis catheters
15806197|NCT04399551|Drug|CAB OLI|CAB will be available as 30 milligrams (mg) tablet. It will be administered as one tablet once daily with food from Day 1 to Month 1.
15806198|NCT04399551|Drug|CAB LA|CAB LA 600 mg will be administered as intramuscular (IM) injection.
15806199|NCT04399551|Drug|RPV OLI|RPV will be available as 25 mg tablet. It will be administered as one tablet once daily with food from Day 1 to Month 1.
15806200|NCT04399551|Drug|RPV LA|RPV LA 600 mg will be administered as IM injection.
15806201|NCT04399551|Other|Continuous Quality Improvement (CQI) calls|CQI will be attended by the enhanced arm (Arm-E). The CQI calls will be conducted to identify problems/challenges, generate plans to address the challenges, and identify how to measure the change that results from the plan.
15806205|NCT04399525|Drug|Desloratadine Single Dose|Desloratadine (H1-antihistamine): oral tablet (1 x 5 mg), taken with 240 ml water, 4 hours prior to the histamine skin prick
15806206|NCT04399525|Drug|Levocetirizine Single Dose|Levocetirizine (H1-antihistamine): oral tablet (1 x 5 mg), taken with 240 ml water, 4 hours prior to the histamine skin prick
15806207|NCT04399525|Drug|Desloratadine Fourfold Dose|Desloratadine (H1-antihistamine): 2 oral tablets of 5 mg in the evening and 2 oral tablets of 5 mg in the morning, taken with 240 ml water, 14 and 4 hours prior to the histamine skin prick, respectively
15806208|NCT04399525|Drug|Levocetirizine Fourfold Dose|Levocetirizine (H1-antihistamine): 2 oral tablets of 5 mg in the evening and 2 oral tablets of 5 mg in the morning, taken with 240 ml water, 14 and 4 hours prior to the histamine skin prick, respectively.
15806209|NCT04399512|Procedure|Nonsurgical root canal treatment|Nonsurgical root canal treatment will be given
15806210|NCT04399499|Device|MitraClip implantation|The MitraClip® procedure is performed under general anesthesia and orotracheal intubation. The procedure is usually guided by 2 and 3-dimensional transesophageal echocardiography and fluoroscopy. This catheter-based technology is inserted through femoral venous access and advanced in the left atrium through the transseptal puncture. The MitraClip® is provided by 2 arms able to grasp the anterior and posterior mitral leaflets. The goal is to approximate both leaflets creating a double orifice mitral valve mimicking the edge-to-edge surgical repair procedure (Alfieri stitch).
15806212|NCT04399473|Behavioral|Pain Neuroscience Education (PNE)|Participates in the experimental group will receive 15mins X 4 sessions of pain education by the eligible trained physical therapist in addition to usual care PT treatment.
15806213|NCT04399460|Other|Dairy-based commercially available food products|Full-fat milk (3.25% milk, 250 mL), assortment of yogurts, and cheeses
15806214|NCT04399460|Other|Restrictive Eating|Dietitian will assist with 500 kcal/day reduction through limiting of macronutrients 45-65% energy from carbohydrates 20-35% energy from fat 10-35% energy from protein
15806215|NCT04399447|Radiation|Echocardiography|left ventricular systolic function of all participants were measured by tissue motion tracking of mitral annular displacement using PHILIPS
15806216|NCT04399434|Other|test gut microbiota, SCFAs and glucolipid metabolism and insulin sensitivity|test gut microbiota and SCFAs in mothers and their newborns and glucolipid metabolism and insulin sensitivity in mothers
15806217|NCT04399408|Device|Obstetrics Ultrasound (non invasive)|Participants are instructed to preform 1-3 short (3 minuets) ultrasound scans a day according to pre-defined steps.
15806218|NCT04399395|Drug|Naltrexone/bupropion|Approved drug for obesity treatment
15806219|NCT04399395|Other|Lifestyle|Lifestyle
15806220|NCT04399382|Drug|Biologics|The exposure of interest in this observational study is the biological therapy of Tumor Necrosis Factor (TNF) inhibitor, specifically etanercept biosmilar/ infliximab/ adalimumab/ golimumab.
15806221|NCT04399369|Device|SDF|38% silver diamine fluoride solution
15806222|NCT04399369|Device|NaF|5% sodium fluoride varnish
15806226|NCT04399343|Drug|Dexmedetomidine|Dexmedetomidine hydrochloride (200 μg/2 ml) is diluted with normal saline to 50 ml and is continuously intravenous infused at a rate of 0.025 ml/kg/hour (dexmedetomidine 0.1 μg/kg/hour). The intravenous infusion begins immediately after enrollment until 08:00 AM on the postoperative day one.
15806227|NCT04399343|Drug|Normal saline|Normal saline is also diluted with normal saline to 50 ml and is continuously intravenous infused at a rate of 0.025 ml/kg/hour, which is the same with the dexmedetomidine group. The intravenous infusion begins immediately after enrollment until 08:00 AM on the postoperative day one.
15806228|NCT04399317|Device|Flow controlled ventilation (Evone-ventilator)|The new ventilation technique will be applied
15806229|NCT04399304|Procedure|simultaneous bilateral high tibial osteotomy|One-stage simultaneous bilateral high tibial osteotomy
15806230|NCT04399304|Procedure|Staged bilateral high tibial osteotomy|Two-stage bilateral high tibial osteotomy
15806289|NCT04398836|Other|Standard nutrition|Well nurished patients will receive a standard nutrition
15806231|NCT04399278|Diagnostic Test|Diagnostic Test: end-expiratory occlusion (EEO) test|"A set of respiratory and hemodynamic measurements (including cardiac output) will be recorded at each stage:
~T0: baseline.
~T1: At the end of the first EEO (15 sec or 30 sec)
~T2: 1 minute after completion of the first EEO. Return to baseline.
~T3: At the end of the second EEO (15 sec or 30 sec)
~T4: 1 minute after completion of the second EEO. Return to baseline.
~T5: Before the fluid challenge test (4 ml/kg of 0.9% saline over 5 min)
~T6: 1 minute after the end of the fluid challenge
~A first set of measurements will be performed after intubation (before the surgical incision) and will be repeated, if necessary, in case of further decrease in stroke volume during surgery or in case of any clinical indication of volume expansion (i.e., arterial persistent hypotension, major hemorrhage, etc.)."
15806232|NCT04399265|Dietary Supplement|Trehalose|A disaccharide sugar usually used as food preservative, but for this study it is given at a higher dose
15806233|NCT04399265|Dietary Supplement|Maltose|Maltose power
15806234|NCT04399252|Dietary Supplement|Lactobaciltus rhamnosus GG|Participants will take 2 capsules per day of either LGG or placebo.
15806235|NCT04399252|Dietary Supplement|Lactobaciltus rhamnosus GG Placebo|Participants will take 2 capsules per day of LGG placebo
15806237|NCT04399226|Drug|Dexmedetomidine|Group D received 1mg/kg dexmedetomidine+0.5mg/kg propofol intravenous (iv) bolus, 0.5 μg/kg/h dexmedetomidine+ 0.5 mg/kg/h propfol infusion. Group K received 0.125 mL/kg bolus, 0.125 mL/kg/h ketamine+ propofol = ketofol infusion (ketofol was prepared with 4 mg propofol+2 mg ketamine).
15806238|NCT04399213|Procedure|50 µg Histamine|Skin prick through 50 µg/5 µL histamine diHCl
15806239|NCT04399213|Procedure|15 µg Histamine|Skin prick through 15 µg/5 µL histamine diHCl
15806240|NCT04399213|Procedure|5 µg Histamine|Skin prick through 5 µg/5 µL histamine diHCl
15806241|NCT04399213|Procedure|Placebo (saline)|Skin prick through 5 µL saline (0.9% NaCl)
15806242|NCT04399200|Device|Treatment according to standard care recommandation|SDB treatment according to standard care recommandation: Continuous Positive Airway Pressure (CPAP), Mandibular Advancement Device, Positionnal Therapy, Adaptive Servo-Ventilation (ASV), Non-Invasive Ventilation (NIV)
15806243|NCT04399187|Drug|Sodium hypochlorite gel application|Patients treated by scaling and root planing and Sodium hypochlorite gel application, meanwhile in patients of control group scaling and root planing alone was performed.
15806244|NCT04399174|Device|US|
15806245|NCT04399161|Drug|Chlorhexidine mouthwash|A commercially available Chlorhexidine mouth rinse (Hexidine- 0.2 percentage Chlorhexidine gluconate) containing 0.2 percentage chlorhexidine gluconate per 10 ml will be used. 7.5 ml of the concentrate diluted with equal amounts of water to make 15ml will be used for rinsing.
15806246|NCT04399161|Drug|Xylitol|Xylitol mouth rinse at 10 percentage concentration will be used. The mouth rinse will be prepared by dissolving 1.5 gm of xylitol powder in 15 ml of water.
15806247|NCT04399161|Drug|Probiotic|Probiotic mouth rinse will be prepared by using a commercially available probiotic product (Sporolac Plus powder- 1gm sachet containing not less than 1.5 billion cells of Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium longum, Bacillus coagulans, Saccharomyces boulardii). Each sachet will be dissolved in 15 ml of water in a measuring cup and used as a mouth rinse.
15806248|NCT04399148|Drug|Desloratadine 5 mg|Desloratadine (H1-antihistamine): oral tablet (1 x 5 mg), taken with 240 ml water, 4 hours prior to the histamine skin prick
15806249|NCT04399148|Drug|Aprepitant 125 mg|Aprepitant (NK1-antagonist): hard capsule (1 x 125 mg), taken with 240 ml water, 4 hours prior to the histamine skin prick
15806250|NCT04399148|Drug|Ketotifen 1 MG|Ketotifen (H1-antihistamine and mast cell stabilizer): capsule (1 x 1 mg), taken with 240 ml water, 4 hours prior to the histamine skin prick
15806251|NCT04399135|Diagnostic Test|Orthopantomogram X-ray view|taking an X-ray to determine bone loss level and attachment loss level for periodontitis classification
15806252|NCT04399135|Diagnostic Test|Endo-Ice|Included teeth will be dried with 4x4 gauze then tested with a cold test using Endo-Ice.
15806253|NCT04399135|Diagnostic Test|Electric Pulp Tester (EPT)|Included teeth will be dried with 4x4 gauze then tested with an Electric test using electric pulp tester (EPT).
15806254|NCT04399122|Drug|acetaminophen/codeine vs acetaminophen/oxycodone|pain medications
15806255|NCT04399109|Device|TCC-COVID mHealth solution|Patients place their index finger in the pulse oximeter to measure their oxygen saturation and pulse rate twice a day, which will take approximately 5 minutes each time. Patients then enter the results into the TCC-COVID app twice daily, and complete a symptom questionnaire via the TCC-COVID app once daily, which will take approximately 5 minutes. The symptom questionnaire was designed specifically for this study. The measurements and information are directly connected to a clinician interface (KIOLA database) which provides the data of all patients in aggregate and an easy to use responsive format with customisable alerts. The alerts identify if the oxygen saturation levels are low or the pulse rate is out of range. The alerts also identify if a measurement has not been completed in a timely manner and the central monitoring service will contact the patient to check on their safety or if they are experiencing any technical issues. The overall duration of participation will be 14 days.
15806256|NCT04399083|Dietary Supplement|Caffeine|"Caffeine will be administered to each participant following an individualized optimal dosing schedule created by the 2B-Alert app. Individualized caffeine dosing schedules will be created by the 2BAlert app on the smartphone the participant uses to do Smart-PVT tests. Study staff will run the optimization at 1900 on Day 15. The algorithm will recommend caffeine dosing to optimize performance during the Peak Alertness window (e.g. from 0300-0900 on Day 16, 44-50 hours of continuous sleep loss). Doses could be recommended at any hour from 2000 on Day 15 to 0800 on Day 16. HOWEVER, the algorithm will not exceed 800 mg of caffeine across the entire study AND it will not dose more than 300 mg of caffeine at a time. Gum will be chewed for a total of 10 minutes by each participant and then discarded.
~As there will be no placebo in this protocol, randomization and blinding procedures are not necessary. IT IS IMPORTANT TO NOTE THAT SOME PARTICIPANTS MAY NOT RECEIVE CAFFEINE AT ALL."
15806257|NCT04399070|Drug|S-ketamine|The depression patients received propofol and S-ketamine before ECT
15806260|NCT04399057|Diagnostic Test|shear Wave Elastosonography|both the left cavernous body and the right cavernous body are ideally divided longitudinally into three sections: proximal, middle and distal. subsequently for each section of the corpora cavernosa the stiffness of the tissue is calculated by means of a specific Region Of Interest (ROI). the result is expressed in Kilopascals and in a color scale. when registering the stiffness the patient is asked to hold their breath.
15806261|NCT04399044|Procedure|Prophylactic muscle flap|"A muscle flap refers to taking an expendable muscle with its vascular supply and moving it to a new area. In this case, the investigators will take a muscle from the leg or abdomen that is redundant (other muscles perform the same function) and moving it to cover vascular grafts to provide healthy tissue to prevent infection."
15806262|NCT04399031|Other|E-cigarette|Participants will self-administer an experimenter-provided e-cigarette.
15806263|NCT04399018|Other|Diagnostic Test: Flow cytometry analysis of neutrophil myeloperoxidase expression|"Flow cytometry analysis of neutrophil myeloperoxidase expression in peripheral blood samples will be performed within 24 h of MDS diagnostic evaluation and blinded to the reference standard. Peripheral blood samples will be collected in 5 ml (EDTA) anticoagulant plastic tubes and processed within 24 h maximum of collection.
~Blood sample will be stained according to the manufacturers' recommendations with a lyophilized cocktail (LyotubeTM ready-to-use, BD Bioscience).
~At least 10,000 neutrophils will be acquired on a 3-laser, 8-color BD FACSCanto-II TM flow cytometer (BD Biosciences, San José, CA).
~Each marker will be expressed as median, geometric and arithmetic mean, regular and robust coefficient of variation."
15806264|NCT04399005|Other|after-each-case room disinfection|After-each-case room disinfection was defined as after completing each case.
15806265|NCT04399005|Other|daily room disinfection|Daily room disinfection was defined as disinfection after completing 8 non-general anesthesia gastroscopy or 4 general anesthesia gastroscopy.
15806266|NCT04398992|Other|observation|Data were collected by a designed form. Statistic software was used to analyze clinical data.
15806267|NCT04398979|Procedure|Thoracoscopic Atrial fibrillation Ablation|After blunt dissection of the oblique and transverse sinus, an AtriCure Lumitip Dissector was introduced around the pulmonary veins. Pulmonary vein isolation was achieved with an AtriCure Isolator Synergy ablation clamp around the pulmonary vein antrum at least six times for each side. Ganglionated plexus identification and ablation were performed using an AtriCure Synergy ablation pen. The additional superior and inferior ablation lines connecting the bilateral pulmonary vein isolations were created by applying the AtriCure Synergy ablation pen. Following completion of the ablation on the right side, ablation on the left side was accomplished in a similar manner. The ligament of Marshall was dissected by electrical cautery. Conduction block was confirmed upon completion of the ablation procedure on the left side.
15806268|NCT04398966|Device|Prostatic Artery Embolization (HydroPearl® compressible microspheres)|Embolic material
15806269|NCT04398953|Drug|TQ-B3525|TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle.
15806270|NCT04398940|Drug|TQ-B3139|TQ-B3139 capsules administered 600mg orally, twice daily in 28-day cycle.
15806271|NCT04398927|Drug|Folfirinox|Systemic Chemotherapy (Oxaliplatin，5-fluorouracil and Irinotecan)
15806272|NCT04398927|Drug|Sintilimab|Sintilimab
15806273|NCT04398914|Drug|Pyrotinib|Pyrotinib 400 mg taken orally everyday, every 3 weeks, for 4 cycles.
15806274|NCT04398914|Drug|Trastuzumab|"Trastuzumab IV infusion in 3-week cycles.
~Neoadjuvant treatment: 8 milligrams per kilogram (mg/kg) loading dose for Cycle 1, followed by 6 mg/kg for Cycles 2-4.
~Adjuvant treatment: 8 mg/kg loading dose, followed by 6 mg/kg for remaining cycles till completion of 1 year trastuzumab"
15806275|NCT04398914|Drug|Pertuzumab|"Pertuzumab IV infusion in 3-week cycles.
~Neoadjuvant treatment: 840 milligrams (mg) loading dose for Cycle 1, followed by 420 mg for Cycles 2-4.
~Adjuvant treatment: 840 mg loading dose, followed by 420mg for remaining cycles till completion of 1 year pertuzumab"
15806276|NCT04398914|Drug|Nab-paclitaxel|Nab-paclitaxel 100mg/m2 by intravenous (IV) infusion on day1, day8 and day15, every 3 weeks, for 4 cycles.
15806277|NCT04398914|Drug|EC chemotherapy|Epirubicin 90 mg/m2, and cyclophosphamide 600 mg/m2 by intravenous (IV) infusion every 3 weeks for 4 cycles (Cycles 5-8)
15806278|NCT04398914|Drug|Physician's choice|Physician decided chemotherapy for 0-4 cycles.
15806279|NCT04398914|Drug|T-DM1|T-DM1 IV infusion in 3-week cycles. 3.6 mg/kg by intravenous (IV) infusion every 3 weeks for 14 cycles
15806280|NCT04398914|Procedure|Surgery|All participants who are eligible for surgery will undergo surgery and have their pathologic response evaluated.
15806281|NCT04398901|Other|Neurodevelopmental assessments|The investigators will evaluate multiple domains of neurodevelopment at age 3, 4, 5 and 7 years using parental questionnaires and child exams. At age 7 years, the children will have a non-sedated quantitative brain MRI.
15806282|NCT04398888|Other|Banxie Xiexin Decoction (BXD)|A modified Banxie Xiexin Decoction based on Chinese medicine syndrome differentiation.
15806283|NCT04398875|Other|Acupuncture and standard care (ASC)|A semi-standardized treatment protocol and standard care will be employed.
15806284|NCT04398875|Other|Sham acupuncture and standard care (SSC)|Validated non-insertion sham acupuncture (Streitberger sham acupuncture) and standard care will be applied.
15806285|NCT04398875|Other|Standard care (SC)|Standard care will be employed.
15806286|NCT04398849|Biological|Licenced 4CMenB Vaccine|Two doses (0.5 mL each) of Bexsero ® vaccine at least 2 months apart to be given to consenting 14-19 year olds
15806287|NCT04398836|Dietary Supplement|Exclusive Enteral Nutrition|Mulnourished patients will drink an enteral polymeric formula suited to their energy expenditure calculated by 25-30 kcal/kg and at least 1 gr/kg of protein, a minimum of 1500 ml (1500 kcal, 54 gr of protein). The amount of formula to achieve nutritional requirements are based on body weight, but the average intake is of 6-8 cups of formula (36-48 scoops of formula mixed with 1260-1680 ml of water to achieve a concentration of 1 kcal per ml). During this period patients will be guided to avoid eating and drinking anything but the enteral formula. The formula will be supplied to the patients by the investigators. The formula used for this study will be VITAL - suitable for people with disease-related malnutrition and malabsorption. Vital 1.5kcal is peptide-based, nutritionally complete formulation for the dietary management of active phase of Crohn's disease. VITAL includes all the nutritional macro and micronutrients and can serve as a sole source of nutrition.
15806288|NCT04398836|Other|High energy / protein diet.|Mulnourished patients will receive a high energy / protein diet.
15806290|NCT04398823|Drug|Sclerosing foam of Lauromacrogol|Participants in FS will receive enteroscopy with the sclerosing foam of lauromacrogol.
15806291|NCT04398823|Drug|Sclersing liqiud of Lauromacrogol|Participants in LS will receive enteroscopy with the sclerosing liquid of lauromacrogol.
15806292|NCT04398810|Procedure|robotic single port cholecystectomy|"Local anesthetic administration during wound incision In the experimental group and the control group, a local anesthetic was administered to the wound surface when a glove port was installed on the navel at the start of surgery. (bupivacaine 0.5% 14ml subcutaneous injection)
~Residual gas aspiration
~Pulmonary recruitment maneuver In both the experimental group and the control group, before the operation was completed and the wound was closed, the patient was taken to the Trenedelenburg position, and then the pressure of 60 cm H2o in the abdomen was applied, and manual inflation was performed twice, 5 seconds at a time, and pulmonary recruitment was performed.
~Warming of the washing solution in the abdominal cavity"
15806293|NCT04398797|Other|PATINA algorithm|Once a week community nurses receive a list of community dwelling citizens deemed at risk of deterioration that can lead to hospital admission. Nurses assess each citizens situation and initiate intervention if needed (not part of the intervention).
15806294|NCT04398784|Dietary Supplement|Freeze Dried Blueberry Powder - 71717|Single serve packets containing 22.5 grams of powdered freeze-dried whole blueberries; A mix of 2 species, Vaccinium virgatum (ashei)/Vaccinium corymbosum, provided by U.S Highbush Blueberry Council (USHBC). Powders are sealed in single serve packets to protect from light and moisture. Packets are refrigerated except for when distributed to participants; participants are asked to store packets in refrigerator until consumption.
15806295|NCT04398784|Dietary Supplement|USHBC Blueberry Placebo Formula #114|Blueberry flavor- and color-matched placebo powder.
15806296|NCT04398771|Drug|Rosuvastatin/Valsartan|Rovatitan QD for 12 weeks
15806297|NCT04398758|Drug|SanaCutan Basiscreme|In this study, the SanaCutan Basiscreme will be used as a cream for twice daily application on the whole body (eyes and mucous membranes have to be omitted) for a duration of 6 months (main phase) or 12 months (main + follow-up phase) or less (if the child develops atopic dermatitis).
15806298|NCT04398745|Drug|Belantamab mafodotin|Belantamab mafodotin will be provided as lyophilized powder which will be available as 100 milligrams per vial (mg/vial) in single-use vial for reconstitution. Lyophilized belantamab mafodotin will reconstituted using water for injection, dilute with normal 0.9 % saline before use.
15806299|NCT04398732|Drug|Enbrel|As provided in real world practice
15806300|NCT04398719|Radiation|[11C]PBR28|The radiotracer, [11C]PBR28, will be administered at the beginning of each PET scan
15806301|NCT04398719|Drug|Low-dose lipopolysaccharide|Subjects will receive intravenous lipopolysaccharide.
15806302|NCT04398719|Drug|Intradermal Capsaicin|A small dose of capsaicin will be administered by intradermal injection.
15806303|NCT04398706|Biological|Pneumococcal Conjugate Vaccine formulation 1|Pharmaceutical form:liquid Route of administration: intramuscular
15806304|NCT04398706|Biological|Pneumococcal Conjugate Vaccine formulation 2|Pharmaceutical form:liquid Route of administration: intramuscular
15806305|NCT04398706|Biological|Pneumococcal Conjugate Vaccine formulation 3|Pharmaceutical form:liquid Route of administration: intramuscular
15806306|NCT04398706|Biological|Varicella Virus Vaccine Live|Pharmaceutical form:liquid Route of administration: subcutaneous
15806307|NCT04398706|Biological|Measles, Mumps, and Rubella Virus Vaccine Live|Pharmaceutical form:liquid Route of administration: subcutaneous
15806308|NCT04398706|Biological|Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]|Pharmaceutical form:liquid Route of administration: intramuscular
15806309|NCT04398706|Biological|Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate)|Pharmaceutical form:liquid Route of administration: intramuscular
15806310|NCT04398706|Biological|Rotavirus Vaccine, Live, Oral, Pentavalent|Pharmaceutical form:liquid Route of administration: oral
15806311|NCT04398706|Biological|Hepatitis B Vaccine* [Recombinant] *as applicable|Pharmaceutical form:liquid Route of administration: intramuscular
15806312|NCT04398693|Dietary Supplement|Prebiotic|It shall be a double-blinded, randomized, placebo-controlled crossover study and treatment with prebiotic for 4 weeks. After a washout period of 4 weeks, the study protocol will be repeated in the other arm. Participants will receive supplementary diet based on high-amylose cornstarch, which releases large amounts of SCFA (acetate and butyrate) in a sachet with a powder that must be dissolved in a glass of liquid to your choice, during 4 weeks (20 g 2x/day). Participants will undergo anthropometric, biochemistry and GUT microbiota assessment, before and after the end of the first phase of the crossover study. Later, when the inversion of the treatment groups occur all participants will also be subjected to the same procedures before and after the end of the second phase of the study.
15806313|NCT04398680|Drug|Belantamab mafodotin|Belantamab mafodotin will be administered
15806314|NCT04398654|Device|CardioMEMSTM HF sensor - pulmonary artery pressure measurement|CardioMEMSTM HF sensor implantation to meassure pulmonary artery pressure. Evaluation of the pressure curves by telemetric transmission and coordination of necessary adjustments of the therapy.
15806315|NCT04398641|Other|Evaluation of pre- and postoperative gastrointestinal functional outcomes|Gastrointestinal functional outcomes will be evaluated using the LARS and the GIQLI by Eypasch questionnaires.
15806316|NCT04398615|Device|Wearable watch device|Every study participant will be given a wearable watch device at the beginning of the study and will be instructed on how to use the device and to wear it continuously throughout the duration of the study (6 months total follow-up). The device will register biometric data and automatically archived. During the follow-up period both healthcare personnel and investigators will not be aware of data (including fall events) registered by the experimental device.
15806317|NCT04398602|Behavioral|behavior of the leader|A study investigator, expert in both PPH and simulation debriefing, not involved in the simulation, observed each scenario to record and check the team's technical skills according to the established 23 PPH key tasks. The behavioral scores were assigned by two independent observers, experts in communication and evaluation in simulation, who reviewed the videos of each simulation each simulation all participants were asked to complete a survey related to the leader and the team behaviors. Questions required a yes/no answer or an answer based on an ordinal scale (1=poor, 5=excellent).
15806498|NCT04396925|Other|Point-of care Ultrasonography|GPs using POCUS and how it affects clinical judgement
15806318|NCT04398589|Drug|Dexmedetomidine injection|We used 9.5 ml of 0.75% ropivacaine and 0.5 ml (50 μg) of dexmedetomidine each for preemptive suprascapular nerve block and axillary nerve block just before arthroscopic repair of rotator cuff tear.
15806319|NCT04398589|Drug|Saline injection|We used 9.5 ml of 0.75% ropivacaine and 0.5 ml normal saline each for preemptive suprascapular nerve block and axillary nerve block just before arthroscopic repair of rotator cuff tear.
15806320|NCT04398576|Behavioral|Training and support|GP's receive the tools to make early identification of harmful and hazardous alcohol use possible. They are given guidelines to apply a brief intervention. At the start of the study, the T&S-group receives two face-to-face educational trainings of two hours each. Another two face-to-face booster sessions will follow at 6 and at 12 months.
15806321|NCT04398576|Behavioral|Community actions|There will be embedded community-based actions within a local strategy.
15806322|NCT04398550|Other|Specific Carbohydrate Diet|Diet restricts all but simple carbohydrates and allows for inclusion of fresh fruits, vegetables, unprocessed meats, and homemade lactose-free cheese and yogurt.
15806323|NCT04398550|Other|Mediterranean Diet|Diet rich in whole vegetables, fruit, plant-based protein, and olive oil, with moderate amounts of seafood and dairy, and limited in sugar-sweetened goods, red meat, and nutrients like heme and sodium.
15806324|NCT04398537|Device|5mm retraction of clip deployment apparatus.|Advancing the clip to the biopsy site and retracting 5 mm and then deploying. This is one method of standard of care and involves depositing the clip after retraction of the deployment apparatus 5 mm.
15806325|NCT04398537|Device|No retraction of clip deployment apparatus.|This is one method of standard of care and the clip will be deployed at the biopsy site.
15806326|NCT04398524|Drug|ISA101B|ISA101b 3 times plus cemiplimab every 3 weeks for up to 24 months
15806327|NCT04398511|Drug|L brevis|Lactobacillus brevis CD2 lozenges (4 billion CFU) after breakfast, lunch and dinner for 21 days.
15806328|NCT04398511|Drug|Placebo|Placebo lozenges after breakfast, lunch and dinner for 21 days.
15806329|NCT04398498|Diagnostic Test|Diagnostic Test: TruGraf® Testing|5 mL collection PAXgene blood sample
15806330|NCT04398485|Drug|ION251|ION251 administered by IV infusion
15806331|NCT04398472|Behavioral|KIND Challenge|The KIND challenge consists of nominating an activity to complete over a 4 week period. The activities involve doing an activity with others in your neighbourhood. These activities are positive, engaging and feasible to the average individual. Activities adhere to relevant country or state department health and safety guidelines. For example; having a chat with a neighbour online, or bringing in rubbish bins for an elderly neighbour.
15806332|NCT04398459|Drug|Ibrutinib|Each recruited subject will accept Ibrutinib treatment.
15806335|NCT04398433|Drug|INO-3107|INO-3107 administered by IM injection followed by EP using CELLECTRA™ 2000 device at Day 0, Week 3, 6, and 9.
15806336|NCT04398433|Device|CELLECTRA™ 2000|CELLECTRA™ 2000 device used for EP following IM delivery of INO-3107.
15806337|NCT04398420|Device|TVERP|Transurethral Vapor Enucleation Resection of the prostate
15806338|NCT04398420|Device|TURis|Transurethral Vapor Enucleation Resection of the prostate
15806339|NCT04398420|Device|HoLEP|Transurethral Vapor Enucleation Resection of the prostate
15806341|NCT04398394|Device|Cellularis version 1 imaging|Using a new modality for retinal cell imaging, we aim at comparing qualitatively and quantitatively, the morphology of the deepest layer of the retina, the retinal pigment epithelium (RPE) by imaging the people with a prototype instrument (Cellularis version 1).
15806342|NCT04398368|Drug|Gemcitabine Hydrochloride|Given intravesically
15806343|NCT04398355|Combination Product|Chinese traditional rehabilitation|Chinese traditional rehabilitation including acupuncture and Gongfa
15806344|NCT04398329|Drug|HTX-034|HTX-034, Dose A
15806345|NCT04398329|Drug|HTX-034|HTX-034, Dose B
15806346|NCT04398329|Device|Luer lock applicator|Applicator for instillation
15806347|NCT04398329|Drug|HTX-034|HTX-034, Dose C
15806348|NCT04398329|Drug|HTX-034|HTX-034, Dose D
15806349|NCT04398329|Drug|Bupivacaine HCl|Bupivacaine HCl, 50 mg
15806350|NCT04398316|Drug|Lidocaine Iv|2 mg/kg over 5 minutes
15806351|NCT04398316|Drug|HYDROmorphone Injection|1 mg over 5 minutes
15806352|NCT04398303|Biological|ACT-20-MSC|1 million cells / kg body weight in 100 ml in conditioned media
15806353|NCT04398303|Biological|ACT-20-CM|100 ml of conditioned media only
15806354|NCT04398303|Biological|Placebo|100 ml of MEM-α
15806355|NCT04398290|Drug|Inhaled nitric oxide (iNO)|iNO Pulse 250 mcg/kg ideal body weight (IBW)/hour
15806356|NCT04398290|Drug|Nitrogen gas|250 mcg/kg ideal body weight (IBW)/hour
15806357|NCT04398290|Drug|Oxygen gas|Supplemental oxygen administered via nasal cannula
15806358|NCT04398277|Behavioral|Daily Coping Toolkit|"Emotion Labelling Activity: Participants rate 10 discrete negative and positive emotional words on a likert scale (0-4).
~Expressive Writing and Self Distancing Activity: Participants respond to an open-ended prompt to write about their day in an open text box in response to the prompt: What was today like for you? After this is completed, they are prompted that if the experience was very challenging, to revisit that experience in their mind by taking a fly on the wall perspective (Kross & Ayduk, 2016).
~Positive Emotion Generation Activity (1 v. 2 prompts) Participants are prompted to take a deep breath and then respond to 1 (or 2) of 8 possible prompts in which they can generate positive emotions. In response to each, they are asked to describe their thoughts or memories in open-ended text box."
15806359|NCT04398264|Other|COVID-19 positive via testing|Pregnant women admitted to Obstetric Units undergo RT-PCR testing for the detection of SARS-Cov2 (COVID-19 infection)
15806360|NCT04398251|Drug|Febuxostat 40mg Tab|For the uric acid control group, except that lifestyle changes were the same as those in the uric acid non-drug control group, non-drug uric acid control group was given febuxostat to reduce uric acid synthesis. Febuxostat is taken at a dose of 40 mg three times a week.
15806361|NCT04398251|Behavioral|Non-drug control group|All patients in the group are advised to live regularly after operation, drink plenty of water, drink more than 2000ml every day, reduce the intake of high purine food and fructose-rich beverages, increase the intake of fresh vegetables, control weight and exercise regularly
15806362|NCT04398238|Combination Product|evaluation by transfusion medicine specialist|screening for anemia causes and treatment: iron/folate/vitamin B12 supplementation, Erythropoietin administration if indicated
15806363|NCT04398225|Drug|Centanafadine|Extended release capsule
15806364|NCT04398212|Diagnostic Test|mfERG (multifocal-retinogram)|mfERG will be performed for the students to document the effect of CVS on retina
15806365|NCT04398199|Radiation|Hypofractionated Radiation Therapy|The prescribed dose will be 70 Gy in 25 fractions. Participants will radiation therapy once a day for 25 days, Monday through Friday (around 5 weeks).
15806366|NCT04398199|Radiation|Radiation Boost|Undergo simultaneous integrated boost (SIB) to treat both planned target volumes.
15806367|NCT04398186|Diagnostic Test|Anogenital distance measurement|Measurements of AGD and perineal muscle strength
15806368|NCT04398173|Diagnostic Test|multiparametric MRI|T1-w, T2-w, diffusion weighted and dynamic contrast-enhanced imaging
15806369|NCT04398160|Other|HVLA C3/C4 manipulation|The investigator will apply an anterior and lateral translation associated with extension, homolateral inclination and contralateral rotation of the cervical. This procedure will increase the tension of the soft tissues to reduce the remaining slack and, finally, the thrust will be applied in pure rotation. Subsequently the head of the volunteer will be repositioned in the neutral position without applying any pressure and will wait 10 seconds in this position. Finally, the previous procedure will be repeated to the opposite side.
15806370|NCT04398160|Other|Sham technique|The investigator will apply an anterior and lateral translation associated with extension, homolateral inclination and contralateral rotation of the cervical until the perception of tissue tension at the point of contact, holding this position for 10 seconds. The investigator then repositions the head of the volunteer in the neutral position without applying pressure, holding again this position for 10 seconds. Finally, the previous procedure will be repeated for the opposite side.
15806371|NCT04398147|Biological|Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)|Intramuscular administration
15806372|NCT04398147|Biological|Placebo|Intramuscular administration
15806373|NCT04398134|Drug|ABI-H2158|3 X 100 mg tablets for oral administration
15806374|NCT04398134|Drug|Placebo|Sugar pill manufactured to mimic the ABI-H2158 tablets
15806375|NCT04398134|Drug|Entecavir (ETV)|0.5 mg tablet for oral administration
15806376|NCT04398108|Drug|Margetuximab Margetuximab-IV|Drug: Chosen Chemotherapy (Capecitabine) -Oral Capecitabine tablet Drug: Chosen Chemotherapy (Vinorelbine) Vinorelbine -IV Drug: Chosen Chemotherapy (Gemcitabine) Gemcitabine -IV
15806377|NCT04398095|Radiation|Hypofractionated radiotherapy|Resectable or marginally resectable tumors: preoperative hypofractionated 12x 3 Gy radiotherapy (4 days in a week, three weeks) prescribed on planned target volume (tumor volume + elective margins + setup/error margin) with daily image guidance with cone beam-CT or kV-portal position verification.
15806378|NCT04398095|Other|Hyperthermia|Deep hyperthermia (Celsius TCS or BSD-2000) according to local protocol combined with radiotherapy, twice a week.
15806379|NCT04398095|Radiation|Hypofractionated radiotherapy with boost|"Non-resectable/inoperable tumors: definitive hypofractionated 12x 3 Gy radiotherapy prescribed on planned target volume (tumor volume + elective margins + setup/error margin) with simultaneous integrated boost 3.5 Gy per fraction prescribed on boost planned target volume (tumor volume + setup/error margin), 4 days in a week, three weeks.
~Radiotherapy with daily image guidance with cone beam-CT or kV-portal position verification."
15806380|NCT04398069|Procedure|hemodynamic optimisation aiming to achieve normal cerebral perfusion|hemodynamic optimisation aiming to achieve normal cerebral perfusion: titration of catecholamin infusion.
15806381|NCT04398056|Drug|Chemotherapy plus radiotherapy and Toripalimab|"Chemotherapy:
~The PF regimen included 5 g/m2 5-fluorouracil via a continuous intravenous infusion over 120 h and an intravenous administration of 100 mg/m2 cisplatin on day 1 for a maximum of six cycles.
~Radiotherapy, intensity-modulated radiation therapy (IMRT), PTVnx:66-70Gy/30-33F; PTVnd:66～70Gy/30～33F; PTV1:60～64Gy/30～33F; PTV2:50～54Gy/30～33F, 5 fractions per week, for 6 weeks
~Toripalimab 240mg every three weeks (Q3W) began on the first day of radiotherapy until an intolerable toxicity, or disease progression, or withdrawal of consent, or the investigator determines that he or she has to withdraw from treatment, or has been treated for up to 2 years."
15806382|NCT04398030|Device|coil-reinforced soft polymer indwelling cannula|Insulin infusion set will be used for up to 7 days of continuous use or until failure
15806383|NCT04398030|Device|soft Teflon indwelling catheter|Insulin infusion set will be used for up to 7 days of continuous use or until failure
15806384|NCT04398017|Procedure|Transesophageal echography|Ultrasound examination of the heart using a soft tube. The extremity is inserted through the mouth and positioned in the esophagus behind the heart.
15806385|NCT04398004|Drug|Clarithromycin|Treatment with 500 mg Clarithromycin orally twice daily for seven days
15806386|NCT04397991|Other|Furosemide|Patients will receive nebulised furosemide solution 1 mg/kg
15806387|NCT04397991|Other|Placebo|Patients will receive nebulised 0.9% saline
15806389|NCT04397965|Device|Cascade Continuous Glucose Monitor|Continuous Glucose Monitoring
15806390|NCT04397926|Drug|Individualized neoantigen peptides vaccine|Patients received subcutaneous injection of individualized neoantigen peptides vaccine at a dose of 200ug per peptide once a week for 12 weeks
15806391|NCT04397913|Drug|Paracetamol|15 mg/kg, q6h
15806392|NCT04397913|Drug|Ibuprofen|10 mg/kg qd for the 1st day, 5 mg/kg qd for the 2nd and 3rd day
15806393|NCT04397887|Procedure|micro-surgical varicocelectomy|Sub-inguinal micro-surgical varicocelectomy
15806394|NCT04397874|Diagnostic Test|; Computerized cardiotocography (cCTG)|To estimate the correlation between the maternal perception of fetal movement and antepartum computerised cardiotocography parameters.
15806395|NCT04397822|Biological|Blood samples|Blood samples will be collected in peripheral blood at the admission in intensive care unit or in standard care unit to compare platelet inflammasome NLRP3 and others markers
15806396|NCT04397796|Biological|BM-Allo.MSC|BM-Allo.MSC for Infusion, is manufactured from normal donor derived bone marrow product and are phenotypically CD73+, CD90+, CD105+, and negative for CD14-, CD34-, CD45-, HLA-DR-.
15806397|NCT04397796|Biological|Placebo|plasmalyte and human albumin
15806398|NCT04397783|Procedure|construction of an end colostomy|longitudinal incision in the construction of an end colostomy
15806399|NCT04397770|Drug|SHR1210|SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
15806400|NCT04397770|Drug|apatinib mesylate|apatinib Mesylate is a small molecule tyrosine kinase inhibitor,Through selectively inhibiting the tyrosine kinase activity of the vascular endothelial growth factor receptor 2 (VEGFR-2).
15806401|NCT04397770|Drug|Temozolomide Injection|Temozolomide is an imidazole tetrazine derivative of the alkylating agent dacarbazine.Temozolomide is not directly active but undergoes rapid, spontaneous, non-enzymatic conversion at physiologic pH to the cytotoxic compound, monomethyl triazeno imidazole carboxamide (MTIC).
15806402|NCT04397757|Biological|COVID-19 Convalescent Plasma|2 units of COVID-19 convalescent plasma compatible with their blood type
15806403|NCT04397744|Behavioral|Unidas por Vida y Salud prevention program|The Unidas por Vida y Salud (United for Life and Health) prevention program is led by the El Paso Cancer and Chronic Disease Consortium (CCDC), the only Breast and Cervical Cancer Services (BCCS) provider in El Paso. This prevention program will use a well-integrated network of community organizations and health service providers to connect medically underserved women to services. To reach the most underserved women and increase preventive cancer screening and timely follow-up, diagnosis, and treatment, the multi-method approach uses evidence-based strategies, including face-to-face educational sessions led by promotoras (community health workers), client reminders, and provision of community-based navigation services to affordable and free screening services. The program also includes clinic-based navigation for those requiring diagnostics or treatment delivered by trained nurses and case workers.
15806404|NCT04397718|Drug|Degarelix|Degarelix is an FDA-approved drug for prostate cancer
15806405|NCT04397718|Other|Saline|09% Saline
15806406|NCT04397705|Device|Patient Status Engine|Wearable sensors
15806407|NCT04397692|Device|Nitric Oxide delivered via LungFit™ system|Patients will receive inhalations of 80 ppm for 40 min 4 times a day
15806408|NCT04397679|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo 3D CRT
15806409|NCT04397679|Radiation|Intensity-Modulated Radiation Therapy (IMRT)|Undergo IMRT
15806410|NCT04397679|Drug|Temozolomide|Given PO
15806411|NCT04397679|Drug|Chloroquine|Given PO
15806412|NCT04397679|Procedure|Tumor Treating Fields Therapy (TTF)|Undergo TTF
15806413|NCT04397666|Diagnostic Test|conjunctival RT PCR|conjunctival sample in covid-19 patients
15806414|NCT04397653|Drug|Evolocumab|In the intervention arm evolocumab 140 mg subcutaneous every 2 weeks will be administered for 24 weeks to high cardiovascular risk haemodialized statin intolerant patients with hypercholesterolemia
15806415|NCT04397653|Drug|Placebo|In the placebo arm placebo subcutaneous every 2 weeks will be administered for 24 weeks to high cardiovascular risk haemodialized statin intolerant patients with hypercholesterolemia
15806416|NCT04397653|Drug|Ezetimibe|Ezetimibe 10 mg daily will be administered for 24 weeks to high cardiovascular risk haemodialized statin intolerant patients with hypercholesterolemia in both the placebo arm (plus placebo) and in the intervention arm (plus evolocumab)
15806417|NCT04397640|Diagnostic Test|Sonovue|Contrast myocardial echocardiography with sulphur hexafluoride microbubbles Sonovue (Bracco, Milan, Italy) injection and using the time-intensity curves profile to evaluate the myocardial microcirculation.
15806418|NCT04397627|Procedure|Colorectal resection|All patients undergoing elective colorectal surgery with anastomosis will be included in a prospective database after written informed consent.
15806419|NCT04397614|Other|mHealth Assessments|Daily symptom tracker
15806420|NCT04397601|Drug|Folfiri/Bevacizumab|Irinotecan (180 mg/m2), leucovorin (400 mg/m2), fluorouracil as an intravenous bolus of 400 mg/m2, and fluorouracil as a continuous 46-h infusion of 2400 mg/m2 in combination with bevacizumab (5 mg/kg) on day 1 of each 14-day cycle.
15806421|NCT04397601|Drug|Folfiri/Aflibercept|Irinotecan (180 mg/m2), leucovorin (400 mg/m2), fluorouracil as an intravenous bolus of 400 mg/m2, and fluorouracil as a continuous 46-h infusion of 2400 mg/m2 in combination with aflibercept (4 mg/kg) on day 1 of each 14-day cycle.
15806422|NCT04397562|Drug|Levilimab|Levilimab 324 mg
15806423|NCT04397562|Drug|Placebo|Placebo
15806424|NCT04397549|Other|Cervical erector spinae plane block|Cervical erector spinae plane block will be administered before the surgery
15806425|NCT04397549|Device|Intravenous morphine patient controlled analgesia device|24 hour morphine consumption will be recorded
15806426|NCT04397523|Biological|anti-SARS-CoV-2 convalescent plasma|Administration of convalescent plasma obtained from donors with prior documented SARS-CoV-2 infection
15806427|NCT04397510|Drug|Heparin|Nebulized Heparin
15806428|NCT04397510|Drug|0.9% Sodium-chloride|Nebulized 0.9% Sodium Chloride
15806429|NCT04397497|Drug|Mavrilimumab|human monoclonal antibody targeting GM-CSF receptor-alpha
15806430|NCT04397497|Drug|Placebo|matching volume of diluent
15806431|NCT04397484|Drug|0.5% Levobupivacaine|The plane where the sciatic nerve bifurcates will at first be identified by utlrasound. 22-gauge insulated nerve block needle will be inserted in the short axis (out-of-plane) of the ultrasound transducer, and advanced toward the cleavage between the common peroneal nerve and the tibial nerve, which is the easiest location for needle access into subparaneural compartment.Once the needle tip enters the subparaneural compartment 2-3 ml of normal saline will be injected (hydro-distension) to create a halo around both the common peroneal nerve and tibial nerve distally and the sciatic nerve proximally. The needle is then redirected to place its tip into the paraneural sheath of the common peroneal and tibial nerve through the same skin puncture and 15ml of study drug will be injected at each site (total 30ml).
15806467|NCT04397211|Procedure|Angiography-derived FFR|"The percutaneous coronary intervention using drug-eluting stent will be indicated according to following criteria in the Angiography-derived FFR-guided strategy arm
~*Criteria for revascularization: Angiography-derived FFR ≤ 0.80"
15806432|NCT04397484|Drug|2% Xylocaine with adrenaline 1:200,000|The plane where the sciatic nerve bifurcates will at first be identified by utlrasound. 22-gauge insulated nerve block needle will be inserted in the short axis (out-of-plane) of the ultrasound transducer, and advanced toward the cleavage between the common peroneal nerve and the tibial nerve, which is the easiest location for needle access into subparaneural compartment.Once the needle tip enters the subparaneural compartment 2-3 ml of normal saline will be injected (hydro-distension) to create a halo around both the common peroneal nerve and tibial nerve distally and the sciatic nerve proximally. The needle is then redirected to place its tip into the paraneural sheath of the common peroneal and tibial nerve through the same skin puncture and 15ml of study drug will be injected at each site (total 30ml).
15806433|NCT04397471|Procedure|Bone Marrow Harvest|Healthy volunteer bone marrow harvest
15806434|NCT04397458|Drug|Saline|0.9% saline on each side
15806435|NCT04397458|Drug|Bupivacaine|0.25% bupivacaine (50mg) on each side
15806436|NCT04397458|Drug|Dexamethasone|3mg preservative-free dexamethasone on each side
15806437|NCT04397445|Drug|Ranitidine|Ranitidine 300 mg
15806438|NCT04397445|Drug|Placebo|Oral placebo tablet
15806439|NCT04397445|Other|Low nitrite/NDMA meals|Meals containing low levels of nitrites and NDMA
15806440|NCT04397445|Other|High nitrite/NDMA meals|Meals containing higher levels of nitrites and NDMA
15806441|NCT04397419|Dietary Supplement|Red Bull Energy Drink|"The intervention group receives 250 ml Red Bull Energy Drink 2-3 hours after surgery and 500 ml on postoperative day 1.
~Regimen:
~2-3 hours after surgery: 250 ml
~Postoperative day 1: morning and noon (1-1-0-0) 250 ml"
15806442|NCT04397419|Other|Still water|"The control group receives 250 ml still water 2-3 hours after surgery and 500 ml on postoperative day 1.
~Regimen:
~2-3 hours after surgery: 250 ml
~Postoperative day 1: morning and noon (1-1-0-0) 250 ml"
15806443|NCT04397406|Drug|levobupivacaine|The patients will receive 15 ml of 0.125% levobupivacaine.
15806444|NCT04397406|Drug|Dexmedetomidine|The patients will receive 13 ml of 0.125% levobupivacaine and 0.5μg/kg dexmedetomidine diluted in 2 ml saline.
15806445|NCT04397406|Drug|Fentanyl|The patients will receive 13 ml of 0.125% levobupivacaine and 25μg fentanyl diluted in 2 ml saline.
15806446|NCT04397393|Drug|Midazolam|Dosage of Midazolam (in mg) needed to achieve satisfactory level of sedation to perform OPU
15806447|NCT04397380|Device|Thermography|Measure Temperature using Thermal Camera
15806448|NCT04397380|Device|Tympanic Temperature|Measure Temperature using Tympanic Temperature
15806449|NCT04397367|Drug|Ruxolitinib 10 mg twice a day combined with Corticosteroids|Newly diagnosed acute GVHD patients started therapy with methylprednisolone of 1 mg/kg/day after diagnosis. Ruxolitinib was administered at a median of 2 days after the use of methylprednisolone. Participants began oral administration of ruxolitinib at 10 mg twice a day. Ruxolitinib was subsequently tapered due to the resolution of acute GVHD after three months of therapy. A dose-tapering schedule that would discontinue ruxolitinib in three months was recommended.
15806450|NCT04397367|Drug|Ruxolitinib 5 mg twice a day combined with Corticosteroids|Newly diagnosed acute GVHD patients started therapy with methylprednisolone of 1 mg/kg/day after diagnosis. Ruxolitinib was administered at a median of 2 days after the use of methylprednisolone. Participants began oral administration of ruxolitinib at 5 mg twice a day. Ruxolitinib was subsequently tapered due to the resolution of acute GVHD after three months of therapy. A dose-tapering schedule that would discontinue ruxolitinib in three months was recommended.
15806451|NCT04397367|Drug|Ruxolitinib 5 mg once a day combined with Corticosteroids|Newly diagnosed acute GVHD patients started therapy with methylprednisolone of 1 mg/kg/day after diagnosis. Ruxolitinib was administered at a median of 2 days after the use of methylprednisolone. Participants began oral administration of ruxolitinib at 5 mg once a day. Ruxolitinib was subsequently tapered due to the resolution of acute GVHD after three months of therapy. A dose-tapering schedule that would discontinue ruxolitinib in three months was recommended.
15806452|NCT04397367|Drug|Ruxolitinib 2.5 mg once a day combined with Corticosteroids|Newly diagnosed acute GVHD patients started therapy with methylprednisolone of 1 mg/kg/day after diagnosis. Ruxolitinib was administered at a median of 2 days after the use of methylprednisolone. Participants began oral administration of ruxolitinib at 2.5 mg once a day. Ruxolitinib was subsequently tapered due to the resolution of acute GVHD after three months of therapy. A dose-tapering schedule that would discontinue ruxolitinib in three months was recommended.
15806453|NCT04397354|Drug|Intracochlear Dexamethasone|intracochlear injection of dexamethasone with cochlear implantation
15806454|NCT04397354|Drug|Intratympanic Dexamethasone|intratympanic injection of dexamethasone with cochlear implantation
15806455|NCT04397354|Drug|No additional drugs(control Group)|Control group: No drugs will be injected middle ear with cochlear implantation
15806456|NCT04397341|Drug|docetaxel, cisplatin, fluorouracil|Biweekly Induction regimen with Docetaxel, Cisplatin and Fluorouracil
15806457|NCT04397328|Drug|Hydroxychloroquine|Hydroxychloroquine vs placebo (1:1 design) double blind intervention
15806458|NCT04397328|Drug|Placebo|Hydroxychloroquine vs placebo (1:1 design) double blind intervention
15806459|NCT04397315|Procedure|Pulpotomy to the level of canal orifices|Pulp tissue will be removed till the level of canal orifices.
15806460|NCT04397315|Procedure|Pulpotomy up to superficial 2-3 mm of pulp chamber|Only superficial pulp from the chamber will be removed
15806461|NCT04397302|Diagnostic Test|Role of Sacubitril/Valsartan in Hemodynamic and Echocardiographic Improvement of Heart Failure With Reduced Ejection Fraction|Reverse Remodeling is Associated With Hemodynamic Improvement and Stabilization in Outpatients With Heart Failure With Reduced Ejection Fraction Treated With Sacubitril/Valsartan: an Echocardiographic Study
15806462|NCT04397289|Drug|Heparin and Rivaroxaban|Low molecular weight heparin 5000U ih Q12h was given 24 hours after operation, 5 days after operation Rivaroxaban 10mg PO QD from 24 hours after operation, 30 days after operation
15806463|NCT04397276|Drug|JNJ-70218902|JNJ-70218902 will be administered.
15806465|NCT04397250|Behavioral|High-intensity interval training|Arm-cranking exercise
15806466|NCT04397224|Diagnostic Test|Device interrogation|Ventriculo-ventricular conduction time measurement using device analyzer
15806496|NCT04396938|Drug|Lamotrigine|Active Drug Capsule
15806497|NCT04396938|Drug|Placebos|Placebo Capsule
15806468|NCT04397211|Procedure|IVUS|"The percutaneous coronary intervention using drug-eluting stent will be indicated according to following criteria in the IVUS-guided strategy arm
~*Criteria for revascularization: Minimum lumen area (MLA) ≤ 3mm2 or 3< MLA ≤ 4mm2 & Plaque burden ≥ 70%"
15806469|NCT04397198|Diagnostic Test|Speckle Tracking echocardiography|"Diagnostic tests:
~Speckle Tracking echocardiography with analyzing the myocardial strain, myocardial velocities, 128-multislice CCTA with the evaluation of the Calcium Scoring (total and local) , identifying the coronary stenosis, evaluation of the plaque vulnerability degree, assess polar maps of the myocardium.
~MRI for the evaluation of the percentage of myocardial scar, also the percentage of the viable myocardial tissue using contrast late enhancement sequences, measuring myocardial fibrosis using Q-mass software.
~Diagnostic tests:
~Laboratory assessment for the evaluation of the level of hs-CRP and myocardial necrosis biomarkers"
15806470|NCT04397185|Device|Breast Cancer Locator (BCL) guided partial mastectomy|The BCL is a patient-specific, plastic, bra-like form which is placed on the breast to localize the tumor during surgery.
15806471|NCT04397185|Device|Wire Localized (WL) partial mastectomy|Standard of care procedure
15806472|NCT04397172|Procedure|Study Arm|"First inpatient examination (within 24 hours after admission to ICU):
~Clinical examination
~Laboratory tests, Biobanking, Mitochondrial function testing
~Neurophysiological examination (MVRC recording)
~Follow-up inpatient examinations (day 2, 5 and 10 after admission):
~Clinical examination
~Laboratory tests, Biobanking, Mitochondrial functions testing
~Neurophysiological examination (MVRC recording)
~Day 10 only: Extended neurophysiological examination according to diagnostic criteria
~Day 10 only: Grading of muscle strength (Medical Research Council (MRC) system)
~Follow-up outpatient examination (after discharge from intensive care):
~Clinical examination
~Grading of muscle strength (MRC)
~Modified Rankin Scale (mRS)
~Barthel Scale
~Questionnaires (Short Form (36) Health Survey, Essener Questionnaire for Coping with a Disease and Beck's Depression Inventory II)"
15806473|NCT04397159|Behavioral|Combination Exercise|Flywheel Resistance Plus Aerobic Exercise
15806474|NCT04397146|Dietary Supplement|Oral Nutrition Supplement (ONS)|Consumption of a portion of 300-320kcal (based on a standard single serve for ONS products) with a two hour follow-up. Products include: 2 Prototype Oral Nutrition Supplements (ONS) with 2.4kcal/ml and respectively 9.6% protein and 14.4% protein; 6 Commercially available Oral Nutrition Supplements with varying energy and protein levels.
15806475|NCT04397133|Other|inspiratory muscle training|inspiratory muscle training will be done with Philips Respironics Threshold IMT device starting with resistance of % 50 of MIP value
15806476|NCT04397133|Other|sham intervention|in these group the patients will get sham intervention with Philips Respironics Threshold IMT device
15806477|NCT04397107|Drug|IL-2|Patients were received low dose recombinant human Interleukin-2
15806478|NCT04397094|Drug|Theracal LC|pulpotomy
15806479|NCT04397094|Drug|Formocresol|Pulpotomy
15806480|NCT04397081|Other|HPV test results|The human papillomavirus (HPV) test detects the presence of the human papillomavirus, a virus that can lead to the development of genital warts, abnormal cervical cells or cervical cancer. The procedure includes taking samples of your cervical cells using a soft brush and a flat scraping device called a spatula. This doesn't hurt, and you may not even feel the sample being taken.
15806481|NCT04397068|Procedure|phaco-vitrectomy|phaco-vitrectomy. No other involvement drug or device. Standard of care procedure
15806482|NCT04397055|Dietary Supplement|Cottonseed Oil|Participants are provided about 60% of their required energy for 8 weeks as foods from a 5 day cycle menu that are enriched with Cottonseed Oil
15806483|NCT04397055|Dietary Supplement|Olive Oil|Participants are provided about 60% of their required energy for 8 weeks as foods from a 5 day cycle menu that are enriched with Olive Oil
15806484|NCT04397029|Device|SureTouch|"The first group will consist of 70 women who are believed to be free of masses, recruited during a screening mammography appointment.
~The second group will include 125 women presenting for diagnostic mammography and/or biopsy appointment with known masses identified on mammogram, ultrasound or both.
~Both groups will receive breast cancer screening with mammography and SureTouch."
15806485|NCT04397016|Behavioral|Option Grid Decision Aid|-A table with side-by-side comparisons of treatment options organized as responses to patients' frequently asked questions
15806486|NCT04397003|Biological|Neoantigen DNA vaccine|All study injections will be given intramuscularly using an integrated electroporation device (TDS-IM system, Ichor Medical Systems). At each vaccination time point, patients will receive two injections of the neoantigen DNA vaccine, one injection into each deltoid or lateralis.
15806487|NCT04397003|Drug|Durvalumab|-Supplied by AstraZeneca/MedImmune
15806488|NCT04397003|Device|TDS-IM v2.0 Device|-Integrated electroporation administration system
15806489|NCT04397003|Procedure|Peripheral blood draws|-Pre-treatment, Week 3 (before Cycle 2 chemotherapy), Week 6 (before Cycle 3 chemotherapy), Week 9 (before Cycle 4 chemotherapy), Vaccine Day 1, Vaccine Day 29, Vaccine Day 85, Vaccine Day 141, on even numbers of cycles for durvalumab for one year following completion of vaccine (C8D1, C10D1, C12D1, C14D1, C16D1, C18D1, C20D1)
15806490|NCT04396990|Drug|Dextenza 0.4Mg Ophthalmic Insert|The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration.
15806491|NCT04396990|Drug|Topical Prednisolone|Standard of care topical drop treatment
15806492|NCT04396977|Procedure|Histamine 10 mg/ml skin prick|Skin prick through 5 µL histamine diHCl (10 mg/ml)
15806493|NCT04396977|Procedure|Placebo (saline) skin prick|Skin prick through 5 µL saline (0.9% NaCl)
15806494|NCT04396951|Device|Active external overheating with heating plate, Aragonia ® MTC 400|It is a heating device that is adjustable in height up to 50 cm from the patient and generates radiant heat at low temperature (up to 39 ◦C) distributed evenly. It is equipped with an adjustable 0-9 potentiometer and has a skin temperature probe as a control and safety mechanism Measure during 6 hours with indirect calorimetry in first week
15806495|NCT04396951|Device|Active external overheating with air blanket, Equator Level 1® de Smiths Medical|Composed of a unit that produces hot air and forced air adjustable from 38ºC to 43ºC. Sends hot forced air distributed by tubular blanket that convectively heats the patient by diffusing hot air directed at the patient through the textile pore of the air blanket Measure during 6 hours with indirect calorimetry in first week
15806499|NCT04396912|Procedure|Total thyroidectomy|Patients with thyroid diseases either benign (e.g. multinodular goitre) or malign (e.g. thyroid carcinoma) will be prepared for total thyroidectomy procedure and will be enrolled.
15806500|NCT04396899|Biological|EHM implantation|Implantation of EHM on dysfunctional left or right ventricular myocardium in patients with HFrEF (EF <35%).
15806501|NCT04396886|Drug|Bintrafusp Alfa|Bintrafusp alfa will be administered intravenously every 2 weeks
15806512|NCT04396847|Drug|Lorcaserin Oral Tablet|Lorcasering 10mg Oral Tablet (BID)
15806513|NCT04396847|Drug|Placebo oral tablet|Placebo Oral Tablet (BID)
15806514|NCT04396834|Drug|Lorcaserin Oral Tablet|Lorcasering 10mg Oral Tablet (BID)
15806515|NCT04396834|Drug|Placebo oral tablet|Placebo Oral Tablet (BID)
15806516|NCT04396821|Drug|TST001|TST001 is a humanized IgG1 monoclonal antibody.
15806521|NCT04396795|Drug|Autologous Platelet Rich Plasma|Each injection session will consist of a total of 10 mL PRP infused slowly over a 2-minute period; 5 mL each injected to the right and left corpus cavernosum.
15806522|NCT04396795|Other|Saline solution|Each injection session will consist of a total of 10 mL saline solution infused slowly over a 2-minute period; 5 mL s each injected to the right and left corpus cavernosum
15806523|NCT04396782|Other|Physioterapy rehabilitation with IVR|This program includes: static bicycle with virtual reality glasses, analytical lower limb exercises, global lower limb exerciseswith virtual reality glasses and activities to be done at home.
15806524|NCT04396782|Other|standard physiotherapy rehabilitation|"static bicycle, analytical lower limb exercises, global lower limb exercises and activities to be done at home.
~This group will perform only five minutes of virtual reality play, but will not use their lower limbs. This way, the results of rehabilitation will not be affected and therapists and patients will be blinded."
15806525|NCT04396769|Behavioral|FLOW-PA|Classes were designed to provide the opportunity to be physically activity at a moderate-vigorous level. Each station included exercise options to accommodate varying fitness levels and offer students choice. Heart rate monitors provided consistent biofeedback to students throughout the intervention. Participants were evaluated based on the number of minutes they spent each class between 60-80% of their maximal heart rate. Games were intermixed either as a station or as a break in the circuit (e.g. short game of tag half-way through the workout) to make physical activity enjoyable and engaging.
15806526|NCT04396769|Behavioral|PE class as usual|PE teachers were instructed to teach class as usual. Research staff were not involved in class activities or instruction. In this school district PE class as usual includes sports-based instruction in which students learn the rules to games and then practice playing.
15806527|NCT04396756|Drug|PLN-74809|PLN-74809
15806528|NCT04396756|Drug|Placebo|Placebo
15806529|NCT04396743|Procedure|Periapical surgery with use of prf-high clot and membrane|Periapical surgery will be done followed by placement of prf-high clot into the defect and membrane over the defect before closure of the flap.
15806530|NCT04396743|Procedure|Periapical surgery with use of prf-medium clot and membrane|Periapical surgery will be done followed by placement of prf-medium clot in the defect and membrane over the defect before closure of the flap.
15806531|NCT04396730|Drug|Cannabidiol Oil|400 mg Cannabidiol oil will be administered daily along with oral contraceptives daily for 24 days.
15806532|NCT04396730|Drug|Placebo|Placebo will be administered daily along with oral contraceptives daily for 24 days.
15806533|NCT04396730|Drug|Combined oral contraceptive pill|All participants will receive oral contraceptives
15806534|NCT04396717|Biological|Pritumumab|Pritumumab IgG1 human monoclonal antibody
15806535|NCT04396678|Behavioral|PrEP standard of care+behavioral intervention|The intervention includes three main components: 1) group PrEP engagement sessions, which include four educational sessions that situate PrEP in a broader framework of access and barriers to care, provider/patient communication, sexual health, HIV/STI education, harm reduction around drug use, stigma, risk compensation and safe sex, and health/science literacy; 2) peer navigation, which aims to help women navigate healthcare engagement with the SPARC nurse practitioner and other providers; and 3) an mHealth component, consisting of a two-way text messaging system through which women will receive automated daily messages and weekly messages requesting adherence reports.
15806536|NCT04396665|Behavioral|Precam|6 months Web-App intervention related with: diet, physical activity, self-care and breast cacner risk prevention
15806537|NCT04396652|Procedure|Adductor canal block (ACB) group|Patients will receive ACB under ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.25% Levobupivacaine will be injected in the canal
15806595|NCT04396080|Procedure|Partial restoration in posterior teeth|Teeth in need of onlays that will be treated with this type of treatment, choosing the most suitable material for each patient and following the manufacturer's instructions for their cementing and adhesion.
15806538|NCT04396652|Procedure|Peri-articular injection group|"Patients in group II will receive intraoperative peri-articular (cocktail) injection and will be performed by a single surgeon.
~A periarticular cocktail injection consisting of 90 mL of normal saline, 17.5 mL of 0.5% levobupivacaine, 2 mL of ketorolac (30 mg), and 0.5mg (0.5mL) of adrenaline, The total volume of the cocktail will be 110 mL"
15806539|NCT04396652|Procedure|Adductor canal block and IPACK block group|Patients will receive ACB under ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.25% Levobupivacaine will be injected in the canal IPACK block in which The ultrasound probe will be positioned in the popliteal crease, and needle will be inserted into the medial aspect of the knee from anteromedial to posterolateral direction in a plane between the popliteal artery and the femur and 15 ml of 0.25% Levobupivacaine will be injected
15806540|NCT04396639|Biological|Moroctocog-alfa (AF-CC)|Moroctocog-alfa (AF-CC) is indicated for the control and prevention of hemorrhagic episodes and for routine and surgical prophylaxis in patients with hemophilia A (congenital factor VIII deficiency or classic hemophilia).
15806541|NCT04396613|Procedure|Closure technique|Randomized assignment to one of three known, effective closure techniques
15806542|NCT04396600|Behavioral|MinnRAP Peer Support Program|"The behavioral intervention consists of 1) pairing healthcare workers into Battle Buddies who maintain daily dialogue to detect stress and anxiety and 2) assigning a mental health consultant to each department to facilitate Battle Buddies and provide both small group sessions and individual psychological triage/referrals."
15806543|NCT04396587|Drug|Sufentanil|Sufentanil(0.1μg/kg), Hydromorphone(20μg/kg), or Oxycodone(60μg/kg) was administered before anesthesia induction.
15806544|NCT04396587|Drug|Hydromorphone|Sufentanil(0.1μg/kg), Hydromorphone(20μg/kg), or Oxycodone(60μg/kg) was administered before anesthesia induction.
15806545|NCT04396587|Drug|Oxycodone|Sufentanil(0.1μg/kg), Hydromorphone(20μg/kg), or Oxycodone(60μg/kg) was administered before anesthesia induction.
15806547|NCT04396561|Drug|Paravertebral group (group P):|"In both groups, one reading of mean arterial pressure and heart rate were taken before induction of general anaesthesia and were defined as baseline readings and then were recorded intra-operatively at 15 min intervals.
~Additional bolus doses of fentanyl 0.5µg/kg were given when the mean arterial blood pressure or heart rate raised above 20% of baseline levels."
15806548|NCT04396548|Drug|Midodrine Oral Product|Patients will receive oral 10 mg tablet of midodrine with small sips of water one hour before arrival in the operation room. All patients will be monitored in with noninvasive blood pressure as well as continuous electrocardiogram (ECG) and pulse oximetry (SpO2). Before placement of spinal anesthesia, all patients will receive an IV bolus of 10mL/kg of Lactated Ringer's . Spinal anesthesia (midline puncture) will be performed in sitting position by a staff anesthetist at L3-L4 or L4-L5 with a 25-gauge Withacre needle injecting 12.5 mg of hyperbaric 0.5% bupivacaine (2.5 mL) with 10μg fentanyl. After injection,the patients will be turned supine.
15806549|NCT04396548|Drug|Inert tablet containing sugar (placebo)|: Patients will receive Inert tablet containing sugar (placebo) with small sips of water one hour before arrival in the operation room. All patients will be monitored in with noninvasive blood pressure as well as continuous electrocardiogram (ECG) and pulse oximetry (SpO2). Before placement of spinal anesthesia, all patients will receive an IV bolus of 10mL/kg of Lactated Ringer's . Spinal anesthesia (midline puncture) will be performed in sitting position by a staff anesthetist at L3-L4 or L4-L5 with a 25-gauge Withacre needle injecting 12.5 mg of hyperbaric 0.5% bupivacaine (2.5 mL) with 10μg fentanyl. After injection,the patients will be turned supine
15806552|NCT04396522|Device|noninvasively Bio-electrical Impedance Analysis (BIA)|By means of noninvasively Bio-electrical Impedance Analysis (BIA) to measure body composition, which divides body weight into different components such as lean body mass and fat mass.
15806553|NCT04396509|Behavioral|Maternal Attachment Inventory Score|three month after delivery using Maternal Attachment Inventory (MAI) and a detailed history was taken.
15806554|NCT04396496|Drug|Daratumumab Injection|"DARA is a human monoclonal antibody that specifically recognizes the CD38 molecule that is expressed at a high level in a variety of hematological malignancies, including myeloma cells.
~DARA injection will be given with oral lenalidomide for up to 12 four week cycles."
15806555|NCT04396483|Procedure|Pomeroy's tubal sterilization|Both Fallopian tubes will be grasped by allis forceps and a kokher forceps will be applied below the allis forceps then excision of tubal part above kokher and transfixation of both ends away from each other during cesarean section
15806556|NCT04396483|Procedure|Salpingectomy|Both fallopian tubes will be completely removed during cesarean section
15806557|NCT04396470|Device|tVNS|Participants will be randomized to either the tVNS treatment condition or the sham tVNS (placebo) condition. An identical non-invasive tVNS device will be used in both groups. In the active condition, the device is placed on the external earlobe (tragus), which directly stimulates the vagus nerve. In the sham condition, the device is placed on the external earlobe, providing the same sensations as in the treatment condition, but no stimulation to the vagus nerve. Intervention period: Participants will use the device 1-hr per day for 12 weeks per manufacturer's instructions.
15806558|NCT04396457|Drug|Pembrolizumab|Human PD-1 Monoclonal antibody
15806559|NCT04396457|Drug|Pemetrexed|Antineoplastic antimetabolite
15806596|NCT04396067|Drug|Aerosolized 13 cis retinoic acid|The infected patients will receive Aerosolized 13 cis retinoic acid in gradual in one dose increases froms 0.2 mg/kg/day to 4 mg/kg/day as inhaled 13 cis retinoic acid therapy for 14 days
15806597|NCT04396067|Drug|Aerosolized All trans retinoic acid|The infected patients will receive Aerosolized All trans retinoic acid in gradual one dose increases froms 0.2 mg/kg/day to 4 mg/kg/day as inhaled all trans retinoic acid therapy for 14 days
15806598|NCT04396067|Other|Placebo|Placebo is a pill or tablet that does not contain any study drug.
15806599|NCT04396054|Device|Lag Screws|Method of internal fixation
15806600|NCT04396054|Device|double Y-shaped plates|Method of internal fixation
15806993|NCT04392765|Device|eXciteOSA|eXciteOSA transoral neurostimulation device
15806561|NCT04396431|Behavioral|education|"The intervention group was offered a six-hour training program based on the transtheoretical model in order to promote sun protection behavior and to reinforce self-efficacy. The program was prepared by the researchers in consideration of the SunSmart Program implemented in Australia, the SunWise School Program developed by the United States Environmental Protection Agency. The program included various educational tools such as a sun protection story, activity book, PowerPoint presentations, cartoons, and puzzles.
~Refresher training was conducted 15 days, 1 month, and 2 months after the initial training. Sun protection behavior and self-efficacy of the children were evaluated at the beginning of the study and six months after the program. As gifts to support their sun protection behavior, the children were given an FDA-approved sunscreen with 50+ SPF, a white cotton short-sleeved T-shirt as protective clothing, sunglasses with 100% UV protection, and a wide-brimmed hat."
15806562|NCT04396418|Behavioral|Education|Randomization between two groups at site level. One cluster with education and one without.
15806563|NCT04396392|Behavioral|VR-based training|"All interventions will be home-based and self-guided. The participants will work on the interventions after school hours at home.
~All participants will be randomized into four groups (see Figure 1). All participants will receive an introduction module, with information tailored to their study group. Parents will receive an introduction module with information about the study group their adolescents belong to."
15806564|NCT04396379|Device|Implant an epicardial device to reshape the mitral valve annulus|The implant is intended to epicardially reshape the mitral valve annulus and left ventricle without the need for cardiopulmonary bypass (CPB) and open-heart access (atriotomy), in patients with left ventricular dilation and mitral valve insufficiency in patients with ischemic or functional MR.
15806565|NCT04396366|Drug|Active drug|QBW251 Capsule 300mg Oral use, one capsule twice daily.
15806566|NCT04396366|Drug|Placebo|Placebo Capsule 300mg Oral use, one capsule twice daily.
15806567|NCT04396353|Other|Electronic questionnaire|Clinical, anthropometric, and sociodemographic variables to characterize the sample will be collected using the Google Form. The same tool will be used to collect clinical variables (outcomes), as well as to obtain data on the level of physical activity and sedentary behavior time (predictor variables) prior to SARS-CoV-2 contamination. For this, we will use the International Physical Activity Questionnaire (IPAQ).
15806568|NCT04396340|Biological|XMT-1592|XMT-1592 will be administered once every 21 days until disease progression, unacceptable toxicity, or either the patient or study physician determines it is in the best interest of the patient to discontinue participation in the study.
15806569|NCT04396327|Drug|SM-1|diphenhydramine, zolpidem and lorazepam
15806570|NCT04396327|Drug|Active Comparator|diphenhydramine and lorazepam
15806571|NCT04396314|Behavioral|Basic Body Awareness Therapy|Basic Body Awareness Therapy (BBAT), a health oriented, multi-perspective and person-centred approach with a focus on the patient's resources. It is a movement awareness training approach in physiotherapy, aiming to promote movement quality in daily life through self-exploration and self-experience enabling the learning of new movement habits
15806572|NCT04396314|Behavioral|Psychological treatment|Cognitive-behavioural therapy, cognitive processing therapy, cognitive therapy and prolonged exposure therapy
15806573|NCT04396301|Drug|Fydrane®: (Manufacturer DELPHARM TOURS, FRANCE).|Fydrane®. The active substances in Fydrane are: tropicamide 0.04 mg (anticholinergic), phenylephrine hydrochloride 0.62 mg (alpha sympathomimetic) and Lidocaine hydrochloride 2 mg (amide type local anaesthetics) for each 0.2 ml dose, equivalent to 0.2 mg of tropicamide, 3.1 mg of phenylephrine hydrochloride and 10 mg of lidocaine hydrochloride for 1 ml.
15806574|NCT04396288|Device|ultrasound imaging at the forearm and at the tibia|ultrasound imaging will be performed at the radius bone (forearm) and at the tibia, before, during, and after a change of intraosseous blood flow
15806575|NCT04396275|Other|Food-1|Cooked whole navy beans (300 kcal)
15806576|NCT04396275|Other|Food-2|Cooked whole yellow split peas (300 kcal)
15806577|NCT04396275|Other|Food-3|Cooked rice considered as control (300 kcal)
15806578|NCT04396262|Other|Food-1|HTD-blueberry beverage with white bread.
15806579|NCT04396262|Other|Food-2|Sweetened water with white bread as a control.
15806580|NCT04396249|Device|Active tVNS|One electrode tip is used as their common terminal, and the other two electrode tips are respectively connected to the skin surfaces of the auricle and the external auditory meatus. Each subject will have 10 active tVNS sessions.The active tVNS group will be stimulated with a 2 mA current for 30 minutes.
15806581|NCT04396249|Device|Sham tVNS|Each subject will have 10 sham tVNS sessions.The sham tVNS group will be stimulated with a 2 mA current for 30 minutes. Except for the stimulation site, other parameters are the same as active group.
15806584|NCT04396223|Drug|Avelumab Injection|Avelumab administration at 800mg a 1 hour IV infusion once every 14 days during 4 months ½ (median)
15806585|NCT04396223|Drug|Methotrexate 1 GM Injection|methotrexate administration at 1mg/kg/day during 4 months ½ (median)
15806586|NCT04396210|Other|Questionnaire|Eligible patients will be selected electronically from our database and digital agenda. After selection, patients will be contacted via email to participate. Two reminders will be send in case the questionnaire is not filled out: a first reminder after one week, a second reminder after two weeks.
15806587|NCT04396197|Other|Physiotherapy|Daily physiotherapy to include respiratory care and rehabilitation based on the individual therapists clinical reasoning
15806588|NCT04396184|Procedure|Aminolevulinic acid photodynamic therapy|Aminolevulinic acid photodynamic therapy
15806589|NCT04396158|Radiation|radioactive iodine|80-200 mCi of radioactive iodine will be given to thyroid cancer patients
15806590|NCT04396145|Diagnostic Test|Subjective Visual Vertical|All subjects will have Virtual SVV before and after the operation
15806591|NCT04396132|Diagnostic Test|Subjective Visual Vertical with Virtual SVV instrument|The deviation angle will be measured with 15, 30 and 45-degree head tilt to the left and right side while they are standing
15806592|NCT04396106|Drug|AT-527|One 550 mg tablet of AT-527 administered every ~12 hours (twice a day) + SOC for a total of 5 days
15806593|NCT04396106|Other|Placebo|One placebo tablet administered every ~12 hours (twice a day) + SOC for a total of 5 days
15806594|NCT04396093|Behavioral|psychological support|specific questionnaires administration: EORTC QLQ 30, EORTC- PAN 26, HADS, Millon Clinical Multiaxial Inventory
15806601|NCT04396041|Device|Microvascular Plug (MVP)|Patient's Pulmonary AVM(s) treated via transcatheter embolization with Microvascular Plugs.
15806602|NCT04396041|Device|Amplatzer Vascular Plug (AVP)|Patient's Pulmonary AVM(s) treated via transcatheter embolization with Amplatzer Vascular Plugs.
15806603|NCT04396041|Device|Detachable coils|Patient's Pulmonary AVM(s) treated via transcatheter embolization with detachable coils.
15806604|NCT04396028|Other|data collection|retrospective data collection
15806605|NCT04396015|Dietary Supplement|Bulletproof Brain Octane|Medium chain triglyceride oil (MCT)
15806606|NCT04396015|Dietary Supplement|Placebo|Placebo (olive) oil
15806607|NCT04396002|Diagnostic Test|Life Space Questionnaire|This 9-item questionnaire is interested in finding out how much a person gets out and about and the spatial extent of the person's typical life space, i.e., what is the usual range of places in which the person engages in activities within the designated time frame.
15806608|NCT04396002|Diagnostic Test|Low Luminance Questionnaire|This 32-item questionnaire is interested in finding out problems that involve vision under different lighting conditions or feelings that people have about your vision under different lighting conditions.
15806609|NCT04396002|Diagnostic Test|Contrast sensitivity under dim illumination|Participants will be presented with visual targets of different contrast under dim illumination and asked to report when they see the target.
15806610|NCT04396002|Diagnostic Test|Visual field under dim illumination (MAIA)|Sensitivity in the central visual area will be assessed under dim illumination
15806611|NCT04396002|Diagnostic Test|Macular Pigment Optical Density (MPOD)|Participants will be asked to look at a fixation target and the density of their macular pigment will be assessed.
15806612|NCT04396002|Diagnostic Test|Dark Adaptation|After adapting to a dark environment, participants will be exposed a bright flask of light. the time needed for them to recover their sensitivity will be measured.
15806613|NCT04395989|Drug|A1: Pyrotinib with Capecitabine|A1: pyrotinib(EGFR-TKI) 400mg qd and capecitabine 1000mg/m2 bid (d1-d14)
15806614|NCT04395989|Drug|A2: nab-paclitaxel|A2: nab-paclitaxel 100mg qw (three week on one week off)
15806615|NCT04395989|Drug|B1: everolimus with nab-paclitaxel|B1: everolimus 10mg qd combined with nab-paclitaxel 100mg qw (three week on one week off)
15806616|NCT04395989|Drug|B2: nab-paclitaxel|B2: nab-paclitaxel 100mg qw (three week on one week off)
15806617|NCT04395989|Drug|C1: PD-1 with nab-paclitaxel and famitinib|C1: PD-1 antibody SHR1210 200mg q2w and nab-paclitaxel 100mg qw (three week on one week off) and famitinib 20mg qd
15806618|NCT04395989|Drug|C2: nab-paclitaxel|C2: nab-paclitaxel 100mg qw (three week on one week off)
15806619|NCT04395989|Drug|D1: VEGFR and nab-paclitaxel|D1: VEGFR BP102 10mg/kg q2w and nab-paclitaxel 100mg qw (three week on one week off).
15806620|NCT04395989|Drug|D2: nab-paclitaxel|D2: nab-paclitaxel 100mg qw (three week on one week off)
15806621|NCT04395989|Drug|E1: Everolimus with nab-paclitaxel|E1: Everolimus 10mg qd with nab-paclitaxel 100mg qw (three week on one week off)
15806622|NCT04395989|Drug|E2: nab-paclitaxel|E2: nab-paclitaxel 100mg qw (three week on one week off)
15806623|NCT04395976|Other|Ayurveda|The Ayurveda intervention is multimodal and following the principles of Ayurveda as a whole medical system, each participants will be treated with individualised care. From the range of proven Ayurvedic Herbs, combination will be decided based on individual participants, his symptoms and his personality.
15806624|NCT04395963|Device|Tobii Pro Glasses 50 Hz wearable wireless eye tracker|This system can measure eye movements using cameras integrated into the eyeglasses which record the corneal reflection of infrared lighting to track pupil position, mapping the subject's focus of attention on video recordings of the subject's field of vision (gaze).
15806625|NCT04395950|Drug|PF-05221304|PF-05221304 10 mg daily (two 5mg tablets daily in the morning for 6 weeks)
15806626|NCT04395950|Drug|Placebo|Placebo two tablets daily in the morning for 6 weeks
15806627|NCT04395937|Other|exercises|One hour twice a week to practice respiratory exercises, postural exercises, muscular exercises
15806628|NCT04395924|Diagnostic Test|Diagnosis of SARS-Cov2 by RT-PCR and : IgG, Ig M serologies in the amniotoc fluid, the blood cord and the placenta|"During labor and delivery
~Sample of amniotic fluid
~2 samples of blood cord after the birth of the new born
~2 samples of placenta
~These samples will be tested with A RT-PCR COVID-19 test and / or serology's A sample of blood cord and placenta will be frozen at -80 degree C and studied for PCR and viral proteome, cytokines , D-dimers and others inflammatory markers in the PRIMMO Laboratory (Prof. TOUMI and LESPESSAILLES) and after in the Centre of molecular biophysics of CNRS of Orleans (Prof. PICHON)"
15806629|NCT04395911|Device|SCD|cytopheretic device
15806630|NCT04395898|Procedure|pancreaticoduodenectomy|Whipple's procedure
15806631|NCT04395885|Other|Electronic questionnaire|Assess the current sexuality according to the gender using sexual questionnaires for men and women were adapted from the Arabic validated version of the five-item International Index of Erectile Function which is a validated, multidimensional, self-administered questionnaire used for the clinical assessment of erectile dysfunction.and for female Arabic validated version of the Female Sexual Function Index
15806632|NCT04395872|Behavioral|Psychiatric counseling|Patients who are admitted to the COVID-19 care unit of the Catholic University of Daegu Hospital are subject to consultation with the psychiatrist. By retrospectively reviewing the medical records of the request and the results of the subjects, We collected Socio-demographic information, medical severity (oxygen saturation, chest x-ray readings, medication being administered), clinical psychological scale (PHQ-9, GAD-7, PC-PTSD-5, AIS, P4, SF-36, SCL-90-R) This study evaluates whether there is a difference in psychological scale according to differences in socio-demographic status and medical severity, and compares psychological psychological measures before and after referral to mental health medicine to evaluate the effectiveness of psychiatric counseling.
15806633|NCT04395859|Procedure|Questionnaire|At inclusion : Questionnaire collecting data concerning the interruption of IVT treatment
15806634|NCT04395859|Other|Data collection up to 1 year|Data collection up to 1 year after resumption of follow-up: visual acuity, OCT : optical coherence tomography, IVT treatment, complications
15806635|NCT04395820|Diagnostic Test|Lung function test|MBW
15806636|NCT04395820|Diagnostic Test|Imaging|MP-MRI
15806637|NCT04395807|Device|Helmet CPAP|Start-up air flow 40 L/min. Start-up PEEP 5 cmH2O. Max PEEP 20 cmH2O. Oxygen flow / FiO2% according to 92% SpO2 target. Titrations at physician's choice.
15806638|NCT04395807|Device|HFNC|Start-up air flow 30 L/min. Max air flow 60 L/min. Oxygen flow / FiO2% according to 92% SpO2 target. Titrations at physician's choice.
15806639|NCT04395794|Diagnostic Test|SARS-CoV-2-test|Nasopharyngeal and oropharyngeal testing for SARS-CoV-2
15806640|NCT04395794|Other|SARS-CoV-2 questionnaire survey|Questionnaire regarding SARS-CoV-2 symptoms and contact with COVID patients
15806641|NCT04395768|Dietary Supplement|Vitamin C|In addition to the active comparator, which is a combination of 2 drugs and 3 dietary supplements, the experimental treatment arm will also receive Vitamin C (intravenous or oral)
15806642|NCT04395768|Drug|Hydroxychloroquine|Active comparator group will receive: a combination of 2 drugs and 3 dietary supplements
15806643|NCT04395768|Drug|Azithromycin|Active comparator group will receive: a combination of 2 drugs and 3 dietary supplements
15806644|NCT04395768|Dietary Supplement|Zinc Citrate|Active comparator group will receive: a combination of 2 drugs and 3 dietary supplements
15806645|NCT04395768|Dietary Supplement|Vitamin D3|Active comparator group will receive: a combination of 2 drugs and 3 dietary supplements
15806646|NCT04395768|Dietary Supplement|Vitamin B12|Active comparator group will receive: a combination of 2 drugs and 3 dietary supplements
15806647|NCT04395755|Behavioral|Generalized Anxiety Disorder-7 (GAD-7)|The GAD-7 is useful in primary care and mental health settings as a screening tool and symptom severity measure for the four most common anxiety disorders.
15806648|NCT04395755|Behavioral|Patient Health Questionnaire-9 (PHQ-9)|The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression.
15806649|NCT04395742|Other|Data collection|Only data collection
15806650|NCT04395716|Biological|ResCure™|Patients will be treated with nebulized ResCure™
15806651|NCT04395703|Other|Interviews and focus groups|Unstructured and semi-structured interviews with open ended questions.
15806652|NCT04395690|Procedure|Dental Implant Placement in the posterior mandible|Surgery done in the posterior mandible with missing teeth for placing dental implants.
15806653|NCT04395677|Drug|AB-106|"Stage 1: 400mg QD for 3 patients and 600mg QD for 3 patients
~Stage 2: 600mg QD"
15806654|NCT04395664|Device|C3+ Holter Monitor|ECG monitoring
15806655|NCT04395651|Device|PET/CT|It is a prospective clinical study that will include patients known to have lung cancer and referred to nuclear medicine unit to perform 18F-FDG PET/CT for staging and therapy planning as well as patients referred for assessment of response of therapy and restaging.
15806656|NCT04395638|Dietary Supplement|3200IU Vitamin D3 per day for 8 weeks|3200IU Vitamin D3 per day for 8 weeks
15806657|NCT04395638|Dietary Supplement|20,000IU Vitamin D3 per week for 8 weeks|20,000IU Vitamin D3 per week for 8 weeks
15806658|NCT04395625|Procedure|Direct bonding of Orthodontic brackets|Patients in group 1 had their upper right and lower left quadrants bonded with indirect bonding, and their upper left and lower right quadrants with direct bonding
15806659|NCT04395625|Procedure|Indirect bonding of Orthodontic brackets|Patients in group 2 had their upper left and lower right quadrants bonded with indirect bonding, and their upper right and lower left quadrants with direct bonding.
15806660|NCT04395612|Drug|niraparib combined with brivanib|Drug：Niraparib will be administered as a dose of 200 mg orally every day. Drug：Brivanib will be administered as a dose of 400mg orally every day.
15806661|NCT04395612|Drug|niraparib combined with toripalimab|Drug：Niraparib will be administered as a dose of 200 mg orally every day. Drug：Toripalimab will be administered as a dose of 240mg Intravenously every 21days.
15806662|NCT04395599|Other|Cartography of air contamination, environment contamination and biological fluid by Sars-Cov2 during visceral surgery in COVID19 patients.|Air sampling, operating room surfaces sampling and patients' biological fluid sampling for Sars-Cov2 quantification
15806663|NCT04395586|Other|Culture|Culture
15806664|NCT04395573|Device|Accuro|ultrasound device (Accuro, Rivanna Medical, Charlottesville, VA) with automated pattern recognition software programmed (SpineNav3DTM technology) to calculate the depth to epidural space and identify bony landmarks
15806665|NCT04395573|Device|standard ultrasound device|standard ultrasound device (o calculate the depth to epidural space and identify bony landmarks
15806666|NCT04395547|Dietary Supplement|JointAlive™|Combination herbal extract
15806667|NCT04395547|Dietary Supplement|Placebo|Combination placebo product
15806668|NCT04395534|Procedure|Complete mesocolic excision|
15806669|NCT04395521|Behavioral|Diabetic foot self-management support|Daily educational organic or inorganic posts (2 to 5) released in a timed sequence through a Hootsuite application plus peer interactions/support for three months.
15806670|NCT04395508|Drug|Pertuzumab and Trastuzumab Fixed-Dose Combination for Subcutaneous Administration (PH FDC SC)|PH FDC SC is given as a fixed dose (i.e. non-weight based) subcutaneous injection. Two dosage configurations of PH FDC SC may be administered in the study: a 15-millilitre (mL) loading dose consisting of 1200 milligrams (mg) pertuzumab and 600 mg trastuzumab and a 10-mL maintenance dose consisting of 600 mg pertuzumab and 600 mg trastuzumab. Participants who have had ≥6 weeks since their last P+H IV, PH FDC SC, or are receiving trastuzumab SC treatment must receive a loading dose before continuing with maintenance doses for subsequent administrations. Note that participants receiving trastuzumab SC only (i.e. without pertuzumab) must receive a loading dose regardless of time since last treatment.
15806671|NCT04395482|Other|Lung CT scan analysis in COVID-19 patients|This research project will evaluate the morphological characteristics of the lung by CT scan analysis in COVID-19 patients which will be identified as specific patterns using artificial intelligence technology and their impact on outcome.
15806672|NCT04395469|Drug|18F-FAZA|18F-FAZA is a radiotracer used for PET imaging (in combination with MRI) to detect hypoxia in tumours. This scan will be done before and after radiation treatment.
15806673|NCT04395456|Drug|AMY-101|C3 complement inhibitor
15806674|NCT04395456|Other|WFI 5% glucose|Placebo
15806675|NCT04395443|Other|medication reconciliation|the emergency clinical pharmacists will start medication reconciliation with the admitted patients and a full diseases and preadmission medications history will be taken.A comparison between the accuracy and completeness of drug history lists already presented in the profile and drug history taken by the clinical pharmacists to detect the medication discrepancies
15806872|NCT04393779|Device|HARPOON Beating Heart Mitral Valve Repair System (MVRS)|Repair of the chordae tendinae in the mitral valve.
15806676|NCT04395430|Behavioral|Usual Care|"Participants will receive standard care which consist of the following:
~a lifestyle counseling visit
~educational materials
~goal-setting by a healthcare professional, and
~information about general weight management resources.
~weighing scale and measuring tape with instructions to use
~fitness tracker"
15806677|NCT04395430|Behavioral|online KKH Sports Singapore Program with Usual Care|"Participants will receive standard care and basic sports equipment and cooking materials for the online programme.
~The online programme will be available up to 4 days per week (Weekdays evenings and Weekends mornings or early afternoons) and all household family members are invited to participate. The majority of the programming will be run by trained research coordinator and volunteers from KKH and Sports Singapore coaches. A regular rotation of comprehensive programming is provided, which includes online fitness, cooking, nutrition, and peer support classes. Every session includes up to 60 minutes of exercise and/or active play, and each session has an additional special 'theme.' For example, one to two sessions per week includes nutrition related programming (e.g., cooking classes), parent specific activities (e.g., a yoga class), peer support sessions (e.g., small group discussions around issues such as weight stigmatization), and fitness classes (e.g., soccer classes)."
15806678|NCT04395417|Drug|Hyaluronic Acid|Patients were infiltrated with injection single dose 30 mg/2 ml 1500 kilodalton high molecular weight hyaluronic acid at the lateral epicondyle according to the standard technique.
15806679|NCT04395417|Biological|Prolotherapy|Patients were infiltrated with 5cc of dextrose 15% at the lateral epicondyle according to the standard technique. For solution, 1 cc 2% lidocaine, 5 cc 30% hypertonic dextrose and 4 cc 0.9 % isotonic were used.
15806680|NCT04395404|Diagnostic Test|MRI|Patients with unilateral ASS, with and without the prosthesis in situ, are analysed by 3D- magnetic resonance imaging (MRI) with 64 channel head coil using T1 and T2 weighted, DIXON/ IDEAL, and T2 inversion recovery sequences.
15806681|NCT04395391|Diagnostic Test|SARS-CoV-2|Determine usability of study materials and kit
15806682|NCT04395378|Device|Continuous Glucose monitoring DEXCOM G6|Continuous glucose monitoring during flight and normal living life
15806683|NCT04395365|Drug|Co-Trimoxazole 960Mg Dispersible Tablet|Antibiotic prophylaxis of Spontaneous Bacterial Peritonitis
15806684|NCT04395365|Drug|Placebo oral tablet|Placebo
15806685|NCT04395352|Device|Endocuff Vision (ECV)|Detachable disposable (single-use) device that fits over the distal colonoscope end.
15806686|NCT04395339|Drug|Monosialotetrahexosyl ganglioside (GM1)|Ganglioside-Monosialic Acid is added into 250 mL of 0.9% sodium chloride injection, which is given once a day via intravenous drip infusion for 15 days. The first dose is given at 1 day before the start of the radiotherapy.
15806687|NCT04395339|Drug|Control|250 mL of 0.9% sodium chloride injection, which is given once a day via intravenous drip infusion for 15 days. The first dose is given at 1 day before the start of the radiotherapy.
15806688|NCT04395313|Other|no intervention carried out|no intervention was done
15806689|NCT04395300|Other|Web Based Survey|On line survey distributed electronically
15806690|NCT04395287|Behavioral|Leisure screen time|Questionnaire-based assessment of typical amount of time per week spent using screen-based media devices during leisure, assessed at two time points. Continuously scaled in main analyses; a difference is computed (18-month follow-up value minus baseline value). Additionally, screen time amount at the two time points will be scaled categorically, according to being classified as low or high according to WHO criteria for preschool children (Low (recommended): <=1 hour/day, high: >1 hour/day): High-high, high-low, low-high, and low-low.
15806691|NCT04395261|Diagnostic Test|Wideband Tympanometry|
15806692|NCT04395248|Procedure|Exploring potential risk factors of difficult intubation using ultrasound|Before surgery, ultrasound will be used to assess pretracheal soft tissue depth and height and width of tongue base. The distance from the skin to the anterior aspect of the trachea will be measured at three levels: vocal cords, thyroid isthmus, and suprasternal notch. With the patient in a seated position, the convex transducer of a portable ultrasound device (LOGIQTM, GE Healthcare, Chicago, IL, USA) will be introduced to the skin of the neck in the submental region coronally, immediately cephalad to the body of the hyoid bone, and then in the area between the hyoid bone and the symphysis of the mandible. Maximal width of tongue base, tongue base height, and maximal height of mid-tongue will be measured. The laryngoscopy intubation will be performed using a size-3 or -4 Macintosh (Rüsch Inc., Duluth, GA, USA) blade and a styletted endotracheal tube. The laryngoscopic view will be graded according to Cormack and Lehane's classification with external laryngeal pressure applied.
15806693|NCT04395248|Procedure|Radial artery catheterization using ultrasound guidance or blind palpation|For all patients, the wrist will be extended and taped to a board to maintain wrist extension. All patients will receive local skin anesthesia at the anticipated puncture site. All radial artery catheterizations will be performed by anesthesiology residents with similar levels of experience in both blind-palpation and ultrasound-guided radial arterial catheterization. In the ultrasound group, a linear vascular probe of portable ultrasound device (LOGIQTM, GE Healthcare, Chicago, IL, USA) will be applied to the skin to localize the radial artery and a 20-gauge catheter will be inserted distal to the transducer and directed according to the ultrasound image. In the palpation group, the radial artery will be identified by palpation, and the cannula will be directed by continuous or intermittent palpation of arterial pulsation. An attempt is defined as a new penetration of the skin with the needle, followed by an unlimited number of subcutaneous needle redirections.
15806694|NCT04395248|Device|Comparing the effectiveness of preoxygenation between high-flow nasal cannula and facemask|In the HFNC group, preoxygenation will be performed using HFNC (Optiflow™, Fisher & Paykel Healthcare, Auckland, NZ), nasal prongs set at 30 L/min flow of heated and humidified 100% oxygen. In the facemask group, patients will breath spontaneously with an anesthetic facemask and 100% oxygen 15 L/min. Gas flow for HFNC or facemask can be adjusted depending on patients' tolerance. During laryngoscopy intubation, HFNC will be left in place with the nasal flow escalated to 50 L/min of 100% oxygen in order to achieve apneic oxygenation. In the facemask group, the facemask will be removed when apnea occurs. After tracheal intubation, correct placement of the endotracheal tube will be confirmed by capnography and the nasal prongs of the HFNC group will be removed.
15806792|NCT04394494|Other|Motor Imagery. Imaging doing Extension exercises without actually doing them.|This study will compare imagining doing specific extension based exercises for LBP vs. actually performing the exercises. This intervention will be just imaging doing the exercises.
15806873|NCT04393766|Drug|Normal Saline|normal saline(crystalloids)
15806695|NCT04395248|Drug|Type of volatile anesthetics and M-Entropy guidance of anesthesia depth|"At the operating room, a M-Entropy™ sensor and S/5™ module (GE Healthcare, Helsinki, Finland) will be applied to all patients' forehead before induction of anesthesia according to the manufacturer's recommendations. Patients will be randomized to Sevoflurane or Desflurane as the single volatile anesthetics for general anesthesia.
~Besides, patients will be randomized to M-Entropy group or controls. In the M-Entropy group, dosage of volatile anesthetics will be adjusted to achieve the Response and State Entropy value between 40 and 60 from the start of anesthesia to the end of surgery. In the usual care group, dosage of volatile anesthetics will be titrated according to clinical judgment. M-Entropy monitoring will be continued in the usual care group, but the Entropy number and EEG waveform will be concealed from the anesthetist in charge."
15806696|NCT04395235|Other|Survey|A multi-item survey was prepared to assess fellow's perception of residency training. The survey was utilized by our group, understanding of patient vascular anatomy, awareness of the changes based on variations, independent decision-making, differential diagnosis, plan on key surgical steps, and preparation for unexpected bleeding. The answers to the questions asked for each case were analyzed to include senior (3 years and over) - junior (1-2 years) residents.Assistants spend 45 minutes in the survey. Data are entered into SPSS 24.0 for statistical analysis. Wilcoxon Signed Ranks Test was used to determine any significant differences in the measurements between the original CT images, 3D rendered images, the 3D model and CT images of the 3D model. Statistical significance was defined as a p value of less than 0.05. Junior assistants stated that they perceived 2D image statistically better than 3D models compared to the senior assistants (Kruskal-Wallis Test).
15806702|NCT04395209|Other|assesment|muscle strength assessment in stroke individuals
15806703|NCT04395196|Dietary Supplement|Choline bitartrate|Provided in beverage form
15806704|NCT04395196|Dietary Supplement|Placebo|Provided in beverage form
15806705|NCT04395183|Drug|5-Hydroxytryptophan 100 MG|5-HTP 100mg PO BID
15806706|NCT04395183|Drug|Creatine monohydrate|Creatine monohydrate 5g PO qday
15806707|NCT04395183|Drug|placebo matched to 5-HTP|placebo matched to 5-HTP
15806708|NCT04395183|Drug|Placebo|Dextrose either as loose powder (matched to creatine) or encapsulated (matched to 5-HTP)
15806709|NCT04395170|Biological|COVID-19 convalescent plasma|Plasma from convalescent patients with COVID-19 and at the same time receiving supportive therapy, with inactivation / reduction of pathogens, in the scheme of two doses of 200 - 250 mL administered on days 1 and 3 of the intervention.
15806710|NCT04395170|Biological|Anti-COVID-19 human immunoglobulin|"Anti-COVID-19 human immunoglobulin produced by Lifefactors Zona Franca S.A.S, intravenously at a dose of immunoglobulin 10% IgG solution (10% mL vial) for:
~Patient of 50 Kg or more, a dose of 50 mL, administered on days 1 and 3 of treatment.
~Patient under 50 Kg, the dose will be 1 mL / Kg, administered on days 1 and 3 of treatment.
~The supply of anti-COVID-19 human immunoglobulin produced by Lifefactors Zona Franca S.A.S included once it has been authorized by INVIMA and/or the regulatory requirements in force for the production of drugs are met."
15806711|NCT04395170|Drug|Standard (specific) therapy for COVID-19|"Standard therapy for COVID-19 according to the recommended pharmacological recommendations of the Colombian Association of Infectious Diseases - ACIN. This therapy is subject to changes that are defined by the Colombian Health Regulatory Authorities.
~To date, these therapies may include remdesivir, chloroquine, hydroxychloroquine, azithromycin."
15806712|NCT04395144|Procedure|Awake Prone Positioning|Patients will receive instruction to remain in prone position as long and as often as possible, up to 16h/24h
15806713|NCT04395144|Procedure|Standard care|Patients will not receive any special instructions with regards to proning.
15806714|NCT04395131|Device|Clearum HF Hemodialyzer|the hemodialyzer will be used 3x week for 3.5-4.5 hours with a Qb of at least 350 ml/min
15806715|NCT04395118|Behavioral|Mailed Outreach|The investigators will randomize elevated LFT patients (~12,000 patients) using a centrally maintained computer-generated list. Patients will be randomly assigned to one of two HCV screening strategies including: visit-based screening as part of usual care (Group 1) or mailed screening invitation outreach and centralized patient navigation (Group 2).
15806716|NCT04395105|Drug|High-Dose Dexamethasone|IV Dexamethasone administered once daily: 16 mg from day 1 to 5 and 8 mg from day 6 to 10
15806717|NCT04395092|Biological|K-NK002|"K-NK002 will be administered intravenous (IV) on Day -2, Day +7 and Day +28.
~Part One (Safety run-in):
~An initial safety run-in to confirm the starting dose, and safety and tolerability of K-NK002;
~Dose cohort 1 will include 3 patients who will receive a dose of K-NK002 at 1 x 10E7 NK cells per kg.
~Dose cohort 2 will include 3 patients who will receive K-NK002 at 1 x 10E8 NK cells per kg.
~Part Two (Open Enrollment):
~Enrollment into the second part of the study (Open Enrollment) can begin following Part One, confirmation of dose and safety."
15806718|NCT04395092|Procedure|Conditioning Regimen|"From Day -7 to Day -3:
~Melphalan: 140 mg/m2 (100mg/m2 in patients ≥ 60) on Day -7.
~Fludarabine: 40 mg/m2 daily for 4 doses starting on days -7.
~TBI: 2 Gy on Day -3."
15806719|NCT04395092|Procedure|HaploBMT|Bone marrow is the only allowed graft source for patients enrolled in this clinical trial
15806720|NCT04395079|Biological|Durvalumab|Given IV
15806721|NCT04395079|Radiation|Internal Radiation Therapy|Undergo brachytherapy
15806722|NCT04395079|Biological|Tremelimumab|Given IV
15806723|NCT04395066|Diagnostic Test|CD55|CD55 is an important complement regulatory protein that inhibits C3 and C5 activation by blocking the formation and accelerating the decay of new C3 and C5 convertases, both of which mediate downstream actions of all three complement activation pathways, and CD55 protects host cells from complement attack.
15806724|NCT04395053|Drug|SHR1459|"TR group:
~The first period，the subjects will be administrated with SHR-1459 in new formulation, then conduct blood collection within 48h; 7 days washout； The second period，the subjects will be administrated with SHR-1459 in old formulation, then conduct blood collection within 48h.
~RT group:
~The first period，the subjects will be administrated with SHR-1459 in old formulation, then conduct blood collection within 48h; 7 days washout； The second period，the subjects will be administrated with SHR-1459 in new formulation, then conduct blood collection within 48h."
15806725|NCT04395040|Other|Semi-structured interview|Semi-structured interview
15806726|NCT04395027|Device|atrial septal defect closure|The iatrogenic septal defect will be closed in the usual manner
15806727|NCT04395014|Diagnostic Test|2D Echocardiography|In this echocardiographic imaging acquisition protocol, the pregnancy patients, are colocated in the left lateral decubitus position on a clinical bed with the left arm flex and the hand behind the head. All the echocardiographic measurements are taken by the examiner in this position.
15806728|NCT04395001|Drug|duloxetine|All participants will receive duloxetine 30 mg once daily for one week and 60 mg once daily for 24 weeks.
15806729|NCT04395001|Behavioral|Web-based Cognitive Behavioral Therapy (CBT)|The web-based CBT program is an automated program (i.e., users learn skills with interactive, personalized training without any therapist contact) that includes 8, 35- to 45-minute training sessions, each of which provides an educational rationale and training in cognitive or behavioral pain coping skill drawn from face-to-face CBT.
15806730|NCT04395001|Other|Nurse-delivered Motivational Interviewing|Subjects randomized to the duloxetine and web-based Cognitive Behavioral Therapy (CBT) with nurse support will receive 6 phone calls from MI trained nurse at week 3, 6, 10, 14, 18 and 22. Telephone sessions may run for 20 minutes on the average.
15806731|NCT04394975|Combination Product|Biological : Toripalimab Drug: Axitinib|Biological: Toripalimab, Intravenous infusion Drug: Axitinib, oral tablet
15806732|NCT04394975|Drug|sunitinib|Drug: Sunitinib, oral capsule
15806733|NCT04394962|Device|Virtual reality|Patients randomized to the study group, will be provided with the VR headset and sensors. The VR exposure will take place before the ET procedure, during their routine pre-transfer waiting period, in a private room. The patient will be able to choose between three different calming VR environments (3 scenes: beach sunset, palm tree patio or redwood forest) and will be exposed to the chosen VR environment for a continuous duration of 15-30 minutes. The VR exposure will be passive, and the patient can control her observation inside the environment by herself, simply by moving her head. During this period, at any time and for any reason, the patient can discontinue the use of the VR session simply by self-removing the helmet
15806734|NCT04394949|Behavioral|Center for Independent Living SEEKS Team|Center for Independent Living (CIL) consumers randomized to work with a group of CIL employees who received training in SOAR, Customized Employment, Supported Employments, and Benefits Planning (CWIC).
15806735|NCT04394949|Other|Usual Care|Consumers will get same CIL services they would get if they were not enrolled in the study.
15806736|NCT04394936|Drug|Guselkumab|100 mg guselkumab administered subcutaneously
15806737|NCT04394936|Drug|Placebos|Sodiumchloride 0,9% solution for injection
15806738|NCT04394923|Procedure|Modification of the pulmonary vein ablation line|The ablation line previously drawn will be modified regarding the esophageal print position in order to avoid RF application within the red layer of the esophageal print.
15806739|NCT04394923|Procedure|Regular PVI ablation|Blinded to the esophageal position based on the type of AF, closer to the ostium for paroxysmal AF and wider for persistent AF
15806740|NCT04394910|Dietary Supplement|Pomegranate Juice|
15806741|NCT04394910|Dietary Supplement|Placebo Juice|
15806742|NCT04394897|Combination Product|Remifentanil-Propofol admixture|
15806746|NCT04394845|Diagnostic Test|[18F]GTP1|[18F]GTP1 IV bolus injection of up to 370 megabecquerel (MBq) (10 millicurie [mCi]), with a maximum drug mass dose of 10 microgram (μg).
15806747|NCT04394832|Behavioral|Brief cognitive intervention|See the information provided in the experimental arm description.
15806748|NCT04394819|Other|electromyography-triggered electrical stimulation|All treatments were planned as 2 sessions per week, for a total of 10 sessions for 5 weeks. For EMG-trigger-ES application, dual-channel Nu-Tek® brand, Maxi plus 2 Model EMG-trigger-BF-ES Device in our clinic was planned to be used. With EMG-triggered-ES application, while the patient is in a sitting position, shoulder adduction, and the elbow is 90 degrees of flexion and pronation, the patient will extend to the ball of 5 cm in diameter, which is placed as far as the distance between the acromion and the 3rd toe, and then the finger-wrist active extension will be stimulated and then It was planned to apply the ball to be grasped. One of the two 5x5 cm superficial square electrodes of the device was planned to be placed on the extensor carpi radialis and extensor digitorum Communis and the other 2 cm distal.
15806749|NCT04394793|Radiation|Low dose radiation therapy|Patient will be treated with a dose of 70 cGy in one fraction radiation therapy in addition to standard therapy
15806750|NCT04394780|Procedure|cooling|First, patients underwent peritoneal dialysis (PD) at 37 C (standard temperature) and then patients underwent PD cooling. After each PD session, the patient had a CT scan for the study team to study myocardial perfusion at rest and after introduction of a pharmacological stressor.
15806751|NCT04394754|Device|BodyPort|Patients will receive BodyPort, a smart scale that provides advanced cardiac monitoring.
15806752|NCT04394754|Other|Noom|Patients will receive a subscription to use Noom, a personalized diet and weight management application.
15806753|NCT04394754|Other|Conversa|patients will receive a subscription to use Conversa, a personalized automated coaching and motivational application.
15806754|NCT04394741|Device|Intervention-Dry Needling|"Deep Dry Needling into the site of the latent Trigger Point of the upper trapezius muscle.
~1 session in upper trapezius muscle moving the needle up and down ten times."
15806755|NCT04394741|Device|Control-Dry Needling|"Sham Dry Needling into the site of the latent Trigger Point of the upper trapezius muscle with non-penetrating needles
~1 session in upper trapezius muscle moving the needle up and down ten times."
15806756|NCT04394728|Drug|Trabectedin|1.3 mg/m2 with a top-dose of 2.6 mg per cycle, via a central venous catheter as a 24-hour infusion every 21 days.All patients received premedication with dexamethasone 20 mg i.v. 30 min before administration of trabectedin.
15806757|NCT04394715|Other|Electronic Alert|"Providers will see an automated electronic alert for each eligible hyperlipidemia patient at high risk for future atherosclerotic CVD events. This alert will appear when the provider enters the order entry screen in the patient's medical record during the patient's first eligible outpatient visit. The alert consists of a pop up that notifies the physician that the patient is at very high risk for ASCVD events, displays the most recent cholesterol values and the patient's current lipid lowering therapy. It also includes a link to full treatment guidelines for hyperlipidemia, which includes a continuing medical education (CME) option to obtain CME credits."
15806758|NCT04394702|Other|One Shape Single-file rotary system|rotational single file system used for mechanical debridement of root canals
15806759|NCT04394702|Other|manual stainless steel K-file|sequential manual filing with stainless steel K-files
15806764|NCT04394676|Procedure|Pressure applied during RARP|Patients will be randomly assigned to undergo RARP either at a pneumoperitoneum pressure of 12 mmHg (experimental) or 15mm Hg (standard technique).
15806765|NCT04394663|Drug|High-dose oral omeprazole|Local made oral omeprazole 40 mg twice daily will be prescribed for 72 hours after randomization.
15806766|NCT04394663|Drug|Standard IV PPI|Pantoprazole 8mg/hour IV continuous drip will be prescribed for 72 hours after randomization
15806767|NCT04394650|Biological|CC-98633|"Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to produce CC 98633.
~During CC 98633 production, subjects may receive bridging chemotherapy for disease control. Upon successful generation of CC 98633 product, subjects will receive treatment with CC 98633 therapy.
~Study treatment will include lymphodepleting chemotherapy followed by one dose of CC-98633 administered by intravenous (IV) injection."
15806768|NCT04394624|Drug|SAR408701|Pharmaceutical form:concentrate for solution for injection Route of administration: intravenous infusion
15806769|NCT04394624|Drug|ramucirumab|Pharmaceutical form:concentrate for solution for injection Route of administration: intravenous infusion
15806770|NCT04394611|Other|Obstetric ultrasound- doppler examination|Obstetric ultrasound- doppler examination and fetal- maternal assessment Tin (Sn), manganese (Mn), Vanadium (V), Magnesium (Mg), cobalt (Co), nickel (Ni), arsenic (As), chromium (Cr), cadmium (Cd), lead (Pb), mercury (Hg), antimony (Sb), aluminum (Al), zinc (Zn), copper (Cu), selenyum (Se), iron (Fe), vitamin D, vitamin A, vitamin B12 and folate concentrations measurements
15806771|NCT04394598|Drug|Dendrobium Huoshanense Granules|3g tid per day for 5weeks
15806772|NCT04394598|Radiation|Pelvic Radiation|50Gy/25Fx
15806773|NCT04394598|Drug|Capecitabine|625mg/m2 bid Monday-Friday per week
15806774|NCT04394598|Drug|Irinotecan|80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7)
15806775|NCT04394598|Other|Placebo|3g tid per day for 5weeks
15806776|NCT04394585|Behavioral|smart phone app based human coaching program|"experimental arm
~1:1 coaching using smart phone app
~Patients are provided several articles about postoperative care (symptom management, diet, and exercise) in the app.
~Patients are encouraged to report their diet diaries and exercise everyday by the coach.
~Patients can ask to the coach using the app and the coach answer when they check them.
~Comparator arm - Patient have consulting with clinical nutritionist at 1 month and 3 months postoperatively."
15806777|NCT04394572|Biological|Blood sample|All patients included in the study will have blood sample
15806778|NCT04394559|Behavioral|Discharge Order Sets|Discharge order sets will be implemented in the electronic health record and will provide surgeons a guideline for a recommended dose and duration of opioids for each commonly performed orthopedic surgery.
15806779|NCT04394559|Behavioral|Pharmacist-Led Discharge Counseling and Communication|Two visits by a trained inpatient pharmacist, including an intake visit to determine previous barriers to safe medication use, and a discharge counseling session with patients and caregivers regarding safe and effective opioid use after discharge; pharmacist communication with providers regarding the post-discharge pain management plan.
15806780|NCT04394559|Behavioral|Post-discharge Pain Management Follow-up|An outpatient pharmacist pain management follow-up visit (with additional contact as needed) embedded within routine post-operative care for managing pain and opioid use.
15806781|NCT04394559|Behavioral|Patient Engagement Pain Management App|A mobile patient-reported outcomes application for assessing pain, function, and possible development of opioid use disorder.
15806784|NCT04394533|Drug|Prilocaine (Hyperbaric 2%)|2 ml hyperbaric prilocaine
15806785|NCT04394533|Drug|Bupivacaine (Hyperbaric 0.5%)|2 ml hyperbaric bupivacaine
15806786|NCT04394520|Other|Modified Introduction|A variation in the introductory content to motivate participants to complete the survey. Participants will be presented with modified introductory language based on the findings from local focus groups and key informant interviews.
15806787|NCT04394520|Other|Active Opt-in|A variation in the consent mode to motivate participants to complete the survey. Participants will be given the choice to actively opt-in to the survey, if they do not respond, the survey will terminate.
15806788|NCT04394520|Other|Active Opt-out|A variation in the consent mode to motivate participants to complete the survey. Participants will be given the choice to actively opt-out to the survey, if they do not respond, the survey will continue.
15806789|NCT04394520|Other|Passive Opt-in|A variation in the consent mode to motivate participants to complete the survey. Participants will be given the choice to passively opt-in to the survey, if they do not hang-up, the survey will continue.
15806790|NCT04394507|Diagnostic Test|Near-Infrared Fluorescence imaging|.Near-infrared imaging was used to evaluate the function of the superficial lymphatic vessels in the right lower leg and foot as previously described.doi: 10.1161/CIRCIMAGING.118.008074.
15806791|NCT04394507|Diagnostic Test|Strain Gauge Plethysmography|Strain Gauge Plethysmography to asses capillary filtration rate og the lower limb
15806909|NCT04393506|Procedure|Radical surgery|Radical surgery will be performed on the 42th-45th after initiation of inductive therapy
15806793|NCT04394494|Other|Control: Physically performing extension based exercises.|This study will compare imagining doing specific extension based exercises for LBP vs. actually doing them. This intervention will be actually, physically performing the exercises.
15806794|NCT04394481|Drug|Dexmedetomidine|IV injection (1 µg/kg - 100 mL) before anesthetic induction
15806795|NCT04394481|Drug|Ropivacaine|Perinervous injection between C5 and C6 nerve roots / interscalene block (0.75% - 20 mL)
15806796|NCT04394481|Drug|Dexamethasone|IV injection (0.15 mg/kg) during anesthetic induction
15806797|NCT04394468|Device|PlasmaJet|Data will be collected during two contact moments, in particular during her admission for surgical laparoscopy, and during her postoperative check-up. Both of these are standard of care. No additional questionnaires will be taken. During the admission the postoperative pain scoreswill be monitored and collected. The duration of her stay in the hospital will also be recorded. During the postoperative check-up, which takes usually place six weeks after the surgery, complications will registered.
15806798|NCT04394455|Behavioral|Brief cognitive behavioral therapy|9 structured psychotherapy sessions, weekly, 60-90 minutes duration. Provided by one therapist and one co-therapist. Provided through telepsychiatry.
15806799|NCT04394455|Behavioral|Crisis intervention therapy|3 structured sessions of crisis intervention. One session each week for three weeks. Provided by one therapist and one co-therapist. Provided through telepsychiatry.
15806800|NCT04394442|Drug|Hydroxychloroquine|400mg BD first day then 200 mg BD for 5 days
15806801|NCT04394416|Drug|Imatinib|Therapeutic
15806802|NCT04394416|Drug|Placebo oral tablet|Placebo
15806803|NCT04394403|Behavioral|Internet-based guided self-help based on CBT principles|Individuals are provided basic rationale of CBT to deal with stress, worry, anxiety, dysphoria, sleep difficulties, emotion dysregulation, and memories all related to COVID-19
15806804|NCT04394390|Dietary Supplement|vitamin d|vitamin D levels
15806805|NCT04394377|Drug|Group 1: Rivaroxaban 20mg/d followed by enoxaparin/unfractionated heparin when needed|Routine full anticoagulation strategy
15806806|NCT04394377|Drug|Group 2: control group with enoxaparin 40mg/d|Usual standard of care and currently have no indication of full anticoagulation.
15806807|NCT04394364|Device|Bispectral index|The BIS monitor will be attached to patients' forehead before anesthetized and kept until the end of the surgery
15806808|NCT04394351|Drug|Dupilumab|Single-use, prefilled glass syringe
15806809|NCT04394351|Drug|Matching Placebo|Matching formulation and regimen (depending on the weight tier) as dupilumab without the active substance
15806810|NCT04394338|Other|self-gripping mesh placement with plastic sheath in laparoscopic inguinal hernia|to apply these to the mesh graft placement process. In the first step, plastic sheaths self-gripping mesh placement with plastic sheathwere prepared configuration with the standard 9cmx15cm self-gripping mesh. Then the meshes were folded and unfolded over or under the plastic sheaths.
15806811|NCT04394325|Behavioral|Digital information tool|The patients randomized to group A will receive verbal and written information regarding the digital information tool and how to use it, as well as verbal and written information about the study. They will also receive information about the different instruments and surveys they will be asked to answer at different occasions during the RT treatment period. The applied instruments for data collection will be administrated in person or by post at the baseline collection and by post (including pre-paid return envelope) on consecutive collections. Approximately 30 patients (in group A) will be asked to make regular notes in a notebook during the waiting period prior start of RT as well as during RT treatment period. Following completion of the RT treatment period individual in-depth and telephone interviews will take place with 10-12 patients that accept participation.
15806812|NCT04394312|Other|Parent PLAYSHOP|"The Parent PLAYSHOP includes:
~Educational Training- the 75 min workshop will be delivered by a trained facilitator. Parents will be introduced to physical literacy via education, group discussion, and active participation in fundamental movement skills (FMS) based activities. Parents will be provided with modifications to perform activities 'at home'.
~Distribution Education and Activity Resources- At the workshop conclusion parents are given education Resources (e.g. Canada's 24-hour movement guidelines for the early years, activity idea booklet, and a physical literacy handout) and inexpensive activity resources (ball, bean bag, scarves, balloons etc.).
~Provide Follow-up Support- Research staff will send parents a follow-up email with key workshop messages (e.g., rationale and importance of physical literacy); support and encouragement for parents to engage in purposeful play with their child; and an opportunity for parents to provide feedback and/or seek further support."
15806813|NCT04394286|Genetic|SHP648|Participants will receive a single IV infusion of SHP648 in Cohort 1, 2, 3 on Day 0.
15806814|NCT04394273|Other|Exercise|stabilization exercise
15806815|NCT04394260|Behavioral|Savvy Caregiver Program|The SCP program is comprised of weekly, two-hour interactive classes, over six consecutive weeks, the same duration as the proposed intervention. The SCP consists of educational instruction and in-class exercises that engage participants on a functional level. Course learning objectives include: 1) introduction to dementing disorder; 2) caregiver self-care; 3) the anchors of enjoyable involvement; 4) levels of thinking and performance; 5) strengthening the family as a resource for caregiving; and 6) review and integration of the previous sections.
15806816|NCT04394260|Behavioral|Modified LGBT Savvy Group program|The LGBT adapted SCP is the same duration as the existing SCP (i.e., 6 weeks, 2 hours per week, for a total of 12 hours). The program facilitators, clinical study visits and standardized questionnaires are similar for LGBT SCP intervention, however addition or removal of questionnaires is possible.Modifications to the SCP include themes of physical, interpersonal, financial, social, and environmental stressors specific to LGBT caregivers.
15806848|NCT04394000|Other|standard protocol|This protocol contains a routine low dose pharmacological venous thromboembolism (VTE) prophylaxis with LMWH
15806849|NCT04393987|Behavioral|Treatment Compliance Training|Treatment Compliance Training consist of: Introduction of Treatment Compliance Program and Information about the Disease, Therapies for Bipolar Disorder and Importance of Treatment Compliance, Drugs Used for Bipolar Disorder, Effects and Side effects, Strategies to Solve Treatment-Related Problems and Cope with Stress, Beliefs, Attitudes, and Stigmatization Towards Patient/Disease in Bipolar Disorder. The sessions were held in the form of PowerPoint presentations. In the Treatment Compliance Training, lecture, question-answer, homework, sharing experiences, video presentation, summarization were used.The day before each session, patients were phoned and reminded of the time of the session.
15806817|NCT04394260|Behavioral|Focus group|Participants will be asked to return to take part in a 90-minute focus group to discuss their experience with the SCP and how the course material applies to them as a LGBT caregiver. Focus Group: Semi-structured discussion will include, but not be limited to the following questions: 1) Can you tell me about your role as a caregiver? (Probes: living situation, experiences, challenges). 2) What went well with the SCP, and what could be improved? 3) How relevant to your situation as an LGBT caregiver were the course materials? 4) How well did the questionnaire reflect your experiences with discrimination due to sexual orientation and/or gender identity? (Probe about when working with your care recipient's health care providers, in-home aides/visiting nurses, adult day care staff, respite, etc? 5) What are some of the additional caregiver challenges that should be considered in these questionnaires? (Probes: mental health, physical health, and social life strain, Quality of life, stress).
15806818|NCT04394234|Drug|Direct oral anticoagulant (DOACs)|Data of participants newly exposed to individual DOACs that is rivaroxaban, apixaban, dabigatran from 19-Oct-2010 to 31-Dec-2018 will be assessed. No study drug treatment will be administered as part of this observational study.
15806819|NCT04394234|Drug|Warfarin|Data of participants newly exposed to warfarin from 19-Oct-2010 to 31-Dec-2018 will be assessed. No study drug treatment will be administered as part of this observational study.
15806820|NCT04394208|Drug|Silymarin|Silymarin Oral at a dose of 420 mg/day in 3 divided doses.
15806821|NCT04394208|Drug|Placebo|Placebo comparator
15806822|NCT04394195|Other|measurement of circulating sFlt1 concentration|blood circulating sFlt1 concentration will be determined
15806823|NCT04394182|Radiation|Ultra-Low-dose radiotherapy|The total dose to be administered was 0.8 Gy in an only single session including both whole-lungs extended 1cm isometric in all directions.
15806824|NCT04394182|Device|ventilatory support with oxygen therapy|Oxygen Therapy: Nasal Cannula (NC); Ventimask (VMK) or VMK with reservoir
15806825|NCT04394182|Drug|Lopinavir/ritonavir|100/400 mg/12h; 7-10 days
15806826|NCT04394182|Drug|Hydroxychloroquine|200 mg/12h
15806827|NCT04394182|Drug|Azithromycin|500 mg/24h, 3 days
15806828|NCT04394182|Drug|Piperacillin/tazobactam|4 g / 0.5 g administered every 6-8 hours through a vein (directly into the bloodstream), for 5-14 days. Adjustment to kidney function
15806829|NCT04394182|Drug|Low molecular weight heparin|prophylactic doses
15806830|NCT04394182|Drug|Corticosteroid injection|250mg x 3 boluses
15806831|NCT04394182|Drug|Tocilizumab|600mg single dose
15806832|NCT04394169|Behavioral|Intervention program|"Medical visits:
~There will be three medical visits stipulated as follows:
~Visit 1 Intervention Group, four weeks after hospital discharge.
~Visit 2 Intervention Group, eight weeks after hospital discharge.
~Visit 3 Intervention Group, 18 weeks after hospital discharge.
~Components of visits:
~Interview and physical examination.
~Therapeutic education about the intensive care syndrome orally and with a specific document that will be delivered at the end of the visit.
~Therapeutic education around pain. If the patient reports pain, a specific document will be prepared that will be delivered at the end of the visit.
~Psychological intervention:
~Inclusion criteria for psychological intervention: Patients with a score higher than 8 on the HAD (hospital anxiety and depression) test depression subscale.
~Description :
~The intervention protocol consists of 7 weekly sessions lasting one hour and a half. The intervention in depression is based on Rehm's model of self-control."
15806833|NCT04394156|Behavioral|Brief cognitive intervention|See the information provided in the experimental arm description.
15806834|NCT04394143|Drug|AD128|Oral administration of two capsules before sleep for 7 days.
15806835|NCT04394143|Drug|Mannitol|Oral administration of two capsules before sleep for 7 days.
15806836|NCT04394130|Drug|ropivacaine 0.2%|continuous peripheral nerve local anesthetic infusion (ropivacaïne 0.2 %) for 48 hours postoperative.
15806839|NCT04394104|Other|Survey|No intervention is being administered.
15806840|NCT04394091|Device|ultrasensitive PET CT|A 194-cm-long total-body positron emission tomography/computed tomography (PET/CT) scanner (uEXPLORER), has been constructed to offer a transformative platform for human radiotracer imaging in clinical research and healthcare. Its total-body coverage and exceptional sensitivity provide opportunities for innovative studies of physiology, biochemistry, and pharmacology.
15806841|NCT04394078|Other|Online survey|Volunteer individuals enrolled the study after approval an online informed consent form. Sociodemographic data of the participants recorded as an online survey. Then, patient reported outcomes were used to assess depression (Zung depression Scale) and quality of life (WHO Qualiy of Life - Bref version).
15806842|NCT04394065|Device|ultrasensitive positron emission tomography|A 194-cm-long total-body positron emission tomography/computed tomography (PET/CT) scanner (uEXPLORER)
15806843|NCT04394052|Diagnostic Test|MR imaging|Medical imaging
15806844|NCT04394039|Other|Public space exposure|landscapes with nature and/or classified as contemplative (through a CLM psychometric measure) are expected to elicit different brainwave oscillations as compared to noncontemplative ones.
15806845|NCT04394013|Behavioral|Mindfulness intervention|Gentle body stretching with the incorporation of breathing technique
15806846|NCT04394013|Behavioral|Non-Mindfulness intervention|Gentle body stretching without the incorporation of breathing technique
15806847|NCT04394000|Other|thromboprofylaxis protocol|This individualised protocol contains three cornerstones: an increase in dosage of prophylactic LMWH close to therapeutic doses, introduction of routine venous ultrasonography and daily measurements of plasma anti-factor Xa activity
15806850|NCT04393961|Device|Premier Biotech COVID-19 IgG/IgM Rapid test Cassette|"Current emergency situation, there are large numbers of COVID-19 Antibody tests being made available at a record pace.
~The protocol is designed to be test agnostic. However, for this first volley, we have chosen the The COVID-19 IgG and IgM Rapid Test provided by Premier Biotech.
~We chose the Precision Bio test for 4 reasons
~It is available as a single use test kit in one sealed unit.
~It's a rapid test, with results available in 10 minutes.
~It has clear and easy to read instructions already included
~It has one of the lowest false positive rates of known tests at the moment"
15806851|NCT04393948|Radiation|Phase 1|Dose Level 1 - 100 cGy irradiation to a single (right-sided) lung using 6 MV photons delivered using a clinical linear accelerator
15806852|NCT04393948|Radiation|Phase 1|Dose Level 2 - 100 cGy irradiation to both lungs using 6 MV photons delivered using a clinical linear accelerator
15806853|NCT04393948|Radiation|Phase 2|Arm A - No irradiation
15806854|NCT04393948|Radiation|Phase 2|Arm B - 100 cGy irradiation to a single (right-sided) lung using 6 MV photons delivered using a clinical linear accelerator
15806855|NCT04393948|Radiation|Phase 2|Arm C - 100 cGy irradiation to both lungs using 6 MV photons delivered using a clinical linear accelerator
15806856|NCT04393935|Behavioral|Pharmacy delivered PrEP Intervention|Men who are eligible and agree to the clinical screener will be provided with a pre-packaged kit of self-administered tests for HIV, rectal chlamydia, syphilis and gonorrhea and creatinine and directed back to the private area of the pharmacy to perform their screenings. Participants will be asked to return the screening tests to the pharmacy technician. The pharmacy technician will process/ interpret the results of the rapid HIV test first in case a treatment referral needs to be set up. Then s/he will process/interpret the results of a rapid rectal chlamydia, syphilis, gonorrhea and rapid finger prick creatinine test. HIV negative customers will be provided with their results and be given a 7-day prescription for PrEP, culturally appropriate PrEP counseling and a follow-up appointment with a PrEP prescribing physician. Participants will be contacted after 3 months to determine whether they continued PrEP use.
15806857|NCT04393922|Behavioral|Acoustic stimuli (Startle)|A startle stimulus (120 dB, 500 Hz, 50 ms) will be delivered through headphones
15806858|NCT04393909|Behavioral|Diagnostic Uncertainty Educational Curriculum|"A Diagnostic Uncertainty Educational Curriculum will consist of an interactive, one-hour teach-the-teacher workshop delivered to resident-attending pairs early on during their inpatient medicine rotation. During the workshop, we will discuss the motivation behind teaching diagnostic uncertainty, review factors that may predict risk of diagnostic error during hospitalization, introduce the framework. Each resident-attending pair will work through a case-based exercise focused on managing learners' diagnostic uncertainty during rounds. Our research team will also conduct Training for clinical staff working on intervention units and will provide at-the-elbow support during the intervention period of the main trial."
15806859|NCT04393909|Behavioral|Diagnostic Timeout|"A Diagnostic Timeout is a structured pocket guide that clinicians may use to address uncertainty in a step-wise approach for patients who have risk factors for diagnostic error. This tool can be used during or after clinical rounds, inside or outside of a patient's room if the patient is agreeable. The Diagnostic Timeout will be introduced as part of the Diagnostic Uncertainty Educational Curriculum as well as Training."
15806860|NCT04393909|Behavioral|Patient Diagnostic (Dx) Questionnaire|"We will administer a survey, the Dx Questionnaire, to patients which asks a series of questions on communication regarding diagnosis with the care team. Patients admitted to inpatient units within the prior 24 hours will be approached after asking the patient's nurse to determine whether it is the appropriate time to approach for enrollment. Upon explaining the objectives of the survey and obtaining verbal informed consent, patients will be asked to complete the Dx Questionnaire via REDCap on an iPad. Alternatively, the research assistant administering the survey will go through the Dx Questionnaire with the patient and record their answers in REDCap on their behalf. If patients' answers indicate a gap in communication (i.e., an answer of No on a question), the Research Assistant will ask for permission to follow-up within the next few days and will relay the gap in communication to the patients' care team (i.e., nurse)."
15806861|NCT04393909|Behavioral|Enhancements to Epic-integrated Quality & Safety Dashboard|"Epic-integrated Quality and Safety Dashboard, currently in operational use at BWH, will be enhanced to include a new diagnostic safety column. Clinical staff will receive Training and at-the-elbow support by the research team upon implementation."
15806862|NCT04393896|Behavioral|WeChat-based integrative family intervention (WIFI)|The WIFI program will include three key components: psycho-education through WeChat Official Account publications, peer-support through a WeChat chat group, and professional support through WeChat private chat and video call
15806863|NCT04393883|Drug|A) Standard maintenance programme group, pembrolizumab 200mg, every 3 weeks, for a total of 2 years of follow-up and follow-up for 1 year;|(A) Standard maintenance programme group, pembrolizumab 200mg, every 3 weeks, for a total of 2 years of follow-up and follow-up for 1 year;
15806864|NCT04393883|Drug|B) Improvement maintenance programme group, pembrolizumab 200mg, every 6 weeks, for a total of 2 years of follow-up and 1 year follow-up;|(B) Improvement maintenance programme group, pembrolizumab 200mg, every 6 weeks, for a total of 2 years of follow-up and 1 year follow-up;
15806865|NCT04393870|Other|Foccusing on Maryam's Flower|Effect of Focusing on Maryam's Flower During the First Phase of the labor
15806866|NCT04393844|Other|turbo-ject PICC set|The turbo-ject PICC set, which will be used in this study, is the set for peripherally inserted central catheterization. In this study, we will see the difference according to the presence or absence of the hydrophilic coated stiffening obturator included in this turbo-ject PICC set.
15806867|NCT04393831|Procedure|Retzius sparing|Retzius nerve sparing is a specific approach that avoids disrupting the structures involved in urinary and sexual function.
15806868|NCT04393818|Behavioral|Intervention App|Participants allocated to the intervention App will receive access to a fully operational mobile phone App. The App will be used to deliver psychoeducational materials (written and audio-visual), including: emotional training (mindfulness, moral harm, skills to manage emotions), lifestyles behaviour promotion (physical activity, diet, substance abuse, sleep disorders), work environment, and social support.
15806869|NCT04393805|Drug|Low Molecular Weight Heparin|Thromboprophylaxis with Low Molecular Weight Heparin, mostly enoxaparin
15806870|NCT04393792|Drug|Povidone-Iodine|0.23% three times daily (tds) for 3 days
15806871|NCT04393792|Drug|Normal saline|0.9% three times daily (tds) for 3 days
15806875|NCT04393740|Diagnostic Test|scheimpflug imaging using pentacam|corneal tomography imaging using pentacam device (based on Scheimpflug principle )
15806876|NCT04393727|Biological|CONVALESCENT PLASMA|Convalescent plasma will be collected by healthy donors, cured by COVID-19 and, after standard preparation and dosage of neutralizing antibodies, will be administered to patients with SARS-CoV2 pneumonia
15806877|NCT04393714|Procedure|Alveolar ridge preservation after extraction|atraumatic extraction followed by graft material insertion
15806879|NCT04393688|Combination Product|Combination Product: Tri-wire Peripheral Balloon Dilatation Catheter|"Procedure:
~Percutaneous Transluminal Angiography, Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored."
15806880|NCT04393675|Drug|LT5001|Administered twice daily
15806881|NCT04393675|Drug|Placebo|Administered twice daily
15806882|NCT04393662|Diagnostic Test|Measurement of Muscle strength using a dynamometer|"Muscle strength will be measured in the elbow bilaterally using a dynamometer (Biodex System 4 Pro: Biodex Medical Systems, Shirley, NY, USA). Supination tests will be performed with the forearm in neutral position, 60° pronation and 60° supination. The elbow will be in 90° flexion, and the shoulder in 45° flexion. Constant pressure is applied to lever of device for 3 to 5 seconds. Maximum torque will be recorded automatically. For each position, three repetitions of 3s (to 5s) contractions will be performed with a break of 15 (or 30s) between the repetitions. There will be an additional break of 2 minutes between measurements of the supination strength in the different positions. This parameter will be analysed regarding asymmetry between both limbs.
~Isometric endurance of forearm supination will be measured in neutral forearm. Flexion tests will be carried in the same setting as for supination. Flexion tests will be performed with the elbow in 90, 45 and 0° of flexion."
15806883|NCT04393662|Diagnostic Test|Range of motion clinical measurement (shoulder and elbow)|The range of motion parameters (degree) of both shoulders and elbows will be documented. The circumference of the arm will be measured on the line between the medial acromion and the cubital fossa at 1/3 from the cubital fossa
15806884|NCT04393662|Diagnostic Test|Electromyography (EMG)|Electromyographic (EMG) data will be collected using a wireless EMG system (myon AG, Schwarzenberg, Switzerland). Surface electrodes will be placed bilaterally on biceps and triceps following the guidelines of the SENIAM project (Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles)
15806885|NCT04393649|Other|ESOGER|Questionnaire
15806886|NCT04393636|Other|Digital cardiac Counseling|"Screening for reduced physical fitness and digital counseling.
~Screening for smoking and digital counseling.
~Screening for malnutrition and obesity and digital counseling.
~Screening for anxiety and depression and digital counseling.
~Screening for elevated pulmonary risk score and digital counseling."
15806887|NCT04393623|Behavioral|Cognitive Reappraisal|This cognitive reappraisal microintervention lasts 45-60 minutes.
15806888|NCT04393623|Behavioral|Psychoeducation|This psychoeducational microintervention lasts 45-60 minutes.
15806889|NCT04393610|Drug|Lidocaine|Patients will receive lidocaine 3 mg/kg total of 40 ml (control group).
15806890|NCT04393610|Drug|Magnesium Sulphate|Patients will receive lidocaine 3 mg/kg total of 40 ml plus Magnesium sulphate 30 mg/kg maximum 1.5 gm, mixed with the second 20 ml of block solution.
15806891|NCT04393610|Drug|Fentanyl|Patients will receive lidocaine 3 mg/kg total of 40 ml plus fentanyl 1 mcg/kg, mixed with lidocaine given after the first 20 ml of block solution.
15806892|NCT04393597|Drug|DWJ1458 (fasted)|Subjects take single dose of DWJ1458 on a fated condition
15806893|NCT04393597|Drug|DWJ1458 (fed)|Subjects take single dose of DWJ1458 after high-fat diet
15806894|NCT04393584|Drug|Irinotecan|d1 Irinotecan 180mg/m² every two weeks
15806895|NCT04393584|Drug|5-FU|d1-2 5-FU 2450 mg/m² every two weeks
15806896|NCT04393584|Drug|Leucovorin|d1 Leucovorin 200 mg/m² every two weeks
15806897|NCT04393584|Drug|Oxaliplatin|d1 Oxaliplatin 85 mg/m² every two weeks
15806898|NCT04393584|Drug|Docetaxel|d1 Docetaxel 50mg/m2 every two weeks
15806899|NCT04393571|Other|Mobile application|telemedicine is used to overcome distance when patients must travel to receive specialized care. We depend on the available, widely used smartphones via a mobile application to conduct follow up data as regard to patient quality of life and comparing this to conventional follow up visits and whether it help to obtain a complete follow up data
15806900|NCT04393558|Device|ADAM Sensor|ADAM sensor The data collected from this sensor contains a wide range of core and novel respiratory digital biomarkers as a home-based early identification system. The core measurements include: heart rate, heart rate variability, temperature, physical activity (including sleep quality) and respiratory rate. The novel respiratory digital biomarkers include: respiratory cadence (expiration / inspiration time), coughing, swallowing, throat clearing, and talk time.
15806901|NCT04393545|Device|hallux valgus night splint|The HV night splint holds the hallux in abduction in order to provide a correct position. The SP group was given splints consisting of a rigid polyethylene bar along the medial of the hallux, and soft polyform and Velcro fastener parts.
15806902|NCT04393545|Other|exercise|The exercises involved strengthening the AbdH (abductor hallucis) and plantar fascia muscles, and stretching the hallux
15806903|NCT04393545|Other|Electrotherapy|Two self-adhesive electrodes were used. One was placed over the medial distal end of the first metatarsal and the other was attached to the motor point of the AbdH (inferior and posterior to the navicular tuberosity).21 The stimulation intensity was increased until a contraction was observed without causing discomfort and pain. Twenty-minute HVPGS was applied in total over three weekly sessions for four weeks.
15806904|NCT04393532|Device|Su2ura Approximation Device|the use of the study device during a laparoscopic surgery
15806905|NCT04393532|Procedure|Laparoscopic hernia repair surgery|repairing primary umbilical hernia in a laparoscopic procedure using the study device.
15806906|NCT04393519|Device|TIPS procedure|Implantation of TIPS for portal hypertension
15806907|NCT04393506|Drug|Camrelizumab|Inductive therapy with Camrelizumab of 200mg, iv, qd, on day 1, 15, 29.
15806908|NCT04393506|Drug|Apatinib|Inductive therapy with Apatinib of 250mg, po, qd, initiating on day 1, ending on the fifth day before surgery.
15806910|NCT04393506|Radiation|Post-operative radiotherapy/chemoradiotherapy|Post-operative radiotherapy/chemoradiotherapy will be performed within 1.5 months after radical surgery, depending on the post-operative pathologic diagnosis.
15806911|NCT04393493|Drug|Furosemide intravenous solution|Administrated as an 80 mg intravenous bolus every 24 hours in both arms and then as a continuous infusion dosed according to the experimental arm.
15806912|NCT04393493|Drug|Chlortalidone|One 50 mg pill administrated every 24 hours in group B
15806913|NCT04393493|Drug|Spironolactone|One 50 mg pill administrated every 24 hours in group B
15806914|NCT04393480|Other|Robotic therapy|ReoGo™ - Motorika robotic therapy - upper extremity robotic rehabilitation system
15806915|NCT04393480|Other|Conventional therapy|Range of Motion (ROM) exercises, muscle strengthening, balance and mobility training, exercises for enhancing activities of daily life, neurophysiological exercises, turnings, bed movements, bridge building, sitting and transfer training, gait training, proprioceptive exercises, balance exercises on the balance board of those affected by the cerebellar system, occupational therapy, cognitive rehabilitation by the relevant psychologist given to those with cognitive impairment
15806916|NCT04393467|Device|tSMS|tSMS delivered on bilateral motor cortex
15806917|NCT04393467|Device|sham tSMS|sham tSMS delivered on bilateral motor cortex by a non-magnetic steel cylinder, with same size, weight and appearance of the magnet used for real tSMS
15806918|NCT04393454|Drug|Sirolimus 2Mg Tab|Sirolimus (oral) will be started at 2 mg daily. Sirolimus dosing will be titrated to meet serum trough levels of >8 ng/ml, assayed at 7 days after starting a new dose, by chromatography/nmass spectrometry. Once adequate serum levels are met (≥8 ng/ml), the same dosing will be continued until progression of disease as evidenced by imaging, or unacceptable toxicity.
15806919|NCT04393441|Drug|New Artificial Tear Formulation|Topical eye drop
15806920|NCT04393441|Drug|Systane Ultra Multidose|Topical eye drop
15806921|NCT04393428|Other|[TIMP-2]*[IGFBP-7]|[TIMP-2]*[IGFBP-7] mesurement in urine sample relicates of COVID-19 patients admitted to the Montpellier University Hospital
15806922|NCT04393415|Combination Product|stem cells|giving stem cells to patients with covid - 19
15806923|NCT04393402|Procedure|lung ultrasound (LUS)|Patients with Covid-19 Disease and admitted in critical care unit will be performed a LUS
15806924|NCT04393389|Device|"AcoArt Orchid (0.035), AcoArt Tulip (0.018) and AcoArt Litos (0.014) percutaneous transluminal angioplasty (PTA) paclitaxel drug coated balloon catheter manufactured by Acotec Scientific Co., Ltd."|All comers Post Market Clinical Follow-up to continue the surveillance of the Acotec Drug Coated PTA Catheter AcoArt Orchid, AcoArt Tulip and AcoArt Litos in lower limb treatment
15806925|NCT04393376|Diagnostic Test|PSA Glycomics Assay|PSA Glycomics Assay will be performed on urine and blood samples
15806926|NCT04393350|Drug|Lenvatinib|Given PO
15806927|NCT04393350|Drug|Lenvatinib Mesylate|Given PO
15806928|NCT04393350|Biological|Pembrolizumab|Given IV
15806929|NCT04393350|Other|Quality-of-Life Assessment|Ancillary studies
15806930|NCT04393350|Other|Questionnaire Administration|Ancillary studies
15806933|NCT04393311|Drug|Ulinastatin|Ulinastatin administered via IV infusion (200,000/infusion)
15806934|NCT04393311|Drug|Placebo|Placebo to match ulinastatin administered via IV infusion
15806935|NCT04393298|Drug|UCB6114|Study participants will receive predefined doses of UCB6114 administered intravenously at pre-specified time points.
15806936|NCT04393298|Drug|trifluridine/tipiracil|Study participants will receive predefined doses of trifluridine/tipiracil (TFD/TPI) administered as film-coated tablets at pre-specified time points.
15806937|NCT04393298|Drug|mFOLFOX6|Study participants will receive predefined doses of oxaliplatin, Leucovorin and 5-fluorouracil as part of the mFOLFOX6 chemotherapy regimen administered as intravenous (iv) infusion at prespecified time points.
15806938|NCT04393285|Drug|Abemaciclib|Abemaciclib 150mg orally twice a day
15806939|NCT04393285|Drug|Letrozole|Letrozole 2.5mg orally once a day
15806940|NCT04393272|Device|Three dimensional sensor system designed for fall detection (Fearless)|Detection of falls in nursing home residents and acute geriatric hospital patiients
15806941|NCT04393259|Other|Rainbow Clinic Model of Antenatal Care|Rainbow Clinic Model is an antenatal model of care with initial ultrasound scan at 23 weeks' gestation including uterine artery Doppler, frequency of subsequent scans determined using data from this initial scan. Continuity of care is provided by obstetricians and midwives.
15806942|NCT04393246|Drug|EDP1815|EDP1815 is an orally administered pharmaceutical preparation of a single strain of Prevotella histicola isolated from the duodenum of a human donor. EDP1815 is currently in phase 2 clinical development and has European and US approval to initiate a multinational psoriasis study.
15806943|NCT04393246|Drug|Dapagliflozin|Dapagliflozin is a sodium-glucose co-transporter 2 (SGLT-2) inhibitor. Dapagliflozin is licensed for use in the UK for treatment of Type II diabetes. Since this trial is evaluating Dapagliflozin in an unlicensed indication, it is being carried out under a Clinical Trial Authorisation (CTA)
15806944|NCT04393246|Drug|Ambrisentan|Ambrisentan is an endothelin receptor antagonist, and is selective for the type A endothelin receptor (ETA). Ambrisentan was approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and indicated for the treatment of pulmonary arterial hypertension.
15806945|NCT04393246|Other|Standard of care|Regular standard of care for COVID-19 patients
15806946|NCT04393220|Drug|Bevacizumab Injection|15mg/kg (Q3W)
15806947|NCT04393220|Drug|Nivolumab|nivolumab 480 mg IV infusions for 30 minutes q4w
15806948|NCT04393207|Drug|Liposomal bupivacaine|Transverse abdominis plane block will be performed and the neurofascial plane between the internal oblique and the transverse abdominis will be infiltrated with liposomal bupivacaine + bupivacaine or with bupivacaine alone.
15806949|NCT04393207|Drug|Bupivacaine|ransverse abdominis plane block will be performed and the neurofascial plane between the internal oblique and the transverse abdominis will be infiltrated with with bupivacaine alone.
15806950|NCT04393207|Other|Control group|Sham block will be performed
15807356|NCT04389632|Drug|SGN-B6A|Administered into the vein (IV; intravenously)
15806951|NCT04393194|Drug|Vaginal Cream with Applicator [Dose Form]|Patients with symptomatic POP will be assigned as outpatients. After the initial pessary fitting, the patients will be followed up in 2 weeks. If the prolapse is supported, no discomfort, and the patient decides to continue to use the pessary, the pessary fitting is successful. Patients with successful ring pessary fitting, who agree to participate and sign written consent, will be randomized into the vaginal estrogen group and the placebo group. The patients will be followed up every 3 months after wearing pessary combined with vaginal medication, until 1 year after wearing the pessary.
15806952|NCT04393181|Procedure|Heart transplantation 1|Heart transplantation will be performed according to local routines. Recipients will be transplanted with a donor heart with left ventricular dysfunction, defined as an ejection fraction less than 50% or regional hypokinesia.
15806953|NCT04393181|Procedure|Heart transplantation 2|Heart transplantation will be performed according to local routines. Recipients will be transplanted with a donor heart with normal function, according to the recommendations from The International Society for Heart and Lung Transplantation (ISHLT).
15806954|NCT04393168|Combination Product|Lymphatic clearance measurement|The indocyanine green in 5% human albumin solution (tracer) (50 μL) will be injected intradermally in both forearms or both lower legs using MicronJet600 microneedles paying attention to the contralateral symmetry of the injections. The signal at the injection sites will be measured over time using a hand-held portable device LymphMeter 1.0 for the total duration of 3 h. In the first hour, the signal will be measured every 15 minutes followed by measurements every half an hour. Immediately after injection (t=0 h), 1.5 h and 3 h after injection the skin area occupied by the tracer will be measured using a standard near-infrared camera, Fluobeam. The dermal reaction at the injection site will be assessed by observations for presence of redness/erythema and measuring its extent according to the needs. The patient will be constantly observed for the signs of allergic reactions, skin irritations or intolerances.
15806955|NCT04393155|Other|COVID-19+ observational|This is observational -- there is no intervention
15806956|NCT04393103|Drug|Intralipid, 20% Intravenous Emulsion|"Atropine will be administered to ALL PATIENTS by doubling dose method which comprised of administering atropine start-ing from 2mg and to double the dose and administer till com-plete atropinization. Following this an infusion of 10-20% of the atropinizing dose was given every hour.
~Group A (Control Group) : Follow Up of 30 patients.
~Group B (Study Group): 30 patients will receive intralipid AS AN ADJUVANT Three boluses of IFE 15 mg/kg were given over 3 minutes, 20 minutes apart."
15806957|NCT04393103|Drug|Intravenous Atropine Sulfate|Atropine will be administered to ALL PATIENTS in Group A and group B by doubling dose method which comprised of administering atropine start-ing from 2mg and to double the dose and administer till complete atropinization. Following this, an infusion of 10-20% of the atropinizing dose was given every hour.
15806958|NCT04393090|Other|eHealth platform CANKADO|The patients were asked to use the open eHealth platform CANKADO as a digital supporting tool.
15806959|NCT04393077|Behavioral|Emotional Freedom Technique|EFT application was started by showing the meridian points to the participants through the picture. It was advised that these points should be clicked with the index finger and middle finger without hurting, but with certain strokes, and it was ensured that they understood the regions by showing and applying them. Then, the following basic steps, which should be followed by the EFT session (four in total lasting 20 minutes), were carried out in succession with the researcher.
15806960|NCT04393064|Device|fiberoptic endoscopic evaluation of swallowing|"intreventions name :-Fiberoptic endoscopic evaluation of swallowing(FEES) will be performed on all infants enrolled in this study.
~interventions type: flexible nasopharyngeal laryngoscope 3,5 mm in size with portable camera & light source & video recording system will be used. Procedure will be done without anesthesia
~."
15806961|NCT04393051|Drug|Baricitinib Oral Tablet|Baricitinib will be administered by oral route at different dosages according to age and kidney function. The drug will be administered for 14 days, unless occurrence of discontinuation criteria.
15806962|NCT04393038|Drug|ABX464|ABX464 50mg QD for 28 days + Standard of Care
15806963|NCT04393038|Drug|Placebo|Placebo 50mg QD for 28 days + Standard of Care
15806964|NCT04393025|Device|Intracranial Stenting by Intracranial Stent Device|Large Intracranial Vessels with ICSD underwent catheter lab and IC stent is inserted
15806965|NCT04393025|Drug|Optimum medical treatment|Optimum Medical treatment
15806966|NCT04393012|Other|Provide alternative nurse call and communication device|Evaluate impact of providing access to the nurse call system and a speech generating device.
15806967|NCT04392999|Drug|Intraarticular platelet rich plasma cervical facet injection|Injection of PRP into the cervical facet joints.
15806968|NCT04392999|Drug|Corticosteroid injection|Injection of corticosteroid into the cervical facet joints.
15806969|NCT04392986|Other|Sunlight exposure|The weather was sunny and found suitable for outside activity and sunlight exposure program, with a mean temperature of 27.0-28.5 °C, the humidity of 64-80%, and global solar exposure of 1.28 to 2.99 MJ/m2 during treatment.[15] Participants were asked to lie on the beach for 45 minutes per day between 2 to 3 pm to avoid extreme skin irritation and sunburn from direct sunlight exposure.
15806970|NCT04392973|Combination Product|Favipiravir and Hydroxychloroquine|"Route of Administration: Oral (or through Nasogastric tube)
~Dose:
~Favipiravir: Administer 1800 mg (9 tablets) by mouth twice daily for one day, followed by 800mg (4 tablets) twice daily (total days of therapy is 10 days or till hospital discharge)
~Hydroxychloroquine (400mg) twice daily on day 1; for days 2-5 (200mg) twice daily."
15806971|NCT04392960|Drug|[18F]Florbetaben|"Patients will undergo on the same day:
~18F-florbetaben PET-CT scans. The dose to be injected intravenously (6 second/mL) will be 370 MBq (for a 70 Kg patient);
~standard assessment of clonal and organ disease;
~echocardiography;
~cardiac magnetic resonance.
~All the patients will undergo those evaluations at baseline and 6 months after treatment initiation."
15806972|NCT04392947|Device|Transcranial Magnetic Stimulation|MagVenture Coil Cool B70 A/P
15806973|NCT04392947|Device|Sham Transcranial Magnetic Stimulation|MagVenture Coil Cool B70 A/P without TMS being actively delivered
15806991|NCT04392778|Biological|MSC Treatment|"Protocol length: 1 week
~Doses:
~Application: 3 million cells/kg IV-------------------------------------------------0 day
~Application: 3 million cells/kg IV ------------------------------------------------3rd day
~Application: 3 million cells/kg IV -------------------------------------------------6th day
~will be given to patients positively, clinically and radiologically diagnosed with COVID-19, followed with 3 months observation."
15806974|NCT04392934|Procedure|a conservative physiotherapy protocol|5 minutes of ultrasound (Business Line US 50, Medical Italia, Italy) at a frequency of 1 MHz and intensity of 1.5 watts/cm², 20 minutes of conventional TENS (BTL-5000, UK ) applied to the patients. Then Codman's exercises, shoulder wheel activity, isometric exercises, range of motion exercises, capsular stretching, scapular stabilization exercises, and muscle strengthening exercises were done by patients. After the treatment, cold pack was applied to the shoulder for 10 minutes. The modalities in the treatment program were applied for a total of 20 sessions 5 days per week.
15806975|NCT04392921|Drug|Amiodarone|"Patients will undergo one of the two regimens of amiodarone, based on their ability to tolerate po (per os) intake in the post-operative period:
~• All patient will receive 1050mg of amiodarone in 100mL of 5% dextrose administered intravenously initiated at the time of anesthesia induction at a rate of 0.73mg/min or 43.75mg/h and continued over 24 hours followed by:
~If able to tolerate po intake: 400mg po BID for post-operative days 1 to 5 or until the day of discharge (whichever occurs first).
~If unable to tolerate po intake: daily infusion of 1050mg in 100mL of 5% dextrose for postoperative days 1 to 5 or until the day of discharge (whichever occurs first)."
15806976|NCT04392921|Drug|Placebo|"Patients will undergo one of the two schedules or intravenous infusion, based on their ability to tolerate po intake in the post-operative period:
~All patients will receive 100mL of 5% dextrose administered intravenously initiated at the time of anesthesia induction at a rate of 0.73mg/min or 43.75mg/h and continued over 24 hours followed by:
~o If able to tolerate po intake: 400mg po BID for post-operative days 1 to 5 or until the day of discharge (whichever occurs first).
~Esophagectomy patient will receive 100mL of 5% dextrose at the time of anesthesia induction at a rate of what would be 0.73mg/min or 43.75mg/h if it contained 1050mg of amiodarone, followed by daily infusion of 100mL of 5% dextrose for 4 days or until the day of discharge (whichever occurs first)."
15806977|NCT04392908|Other|Communication memory|All groups will undergo audio-recorder interviews. Only adults will complete a self-report questionnaire on phenomenological aspects of autobiographical memories.
15806978|NCT04392895|Procedure|Para Aortic Lymphadenectomy (PAL) by laparoscopy|Para Aortic Lymphadenectomy (PAL) by laparoscopy
15806979|NCT04392882|Behavioral|Legume enriched diet group|"Replacing 1/3 refined rice intake with legumes three times per day
~Vegetable intake at least six units (30-70 g/unit) per day for sufficient dietary fiber intake
~Regular 30-min walk after dinner each day"
15806980|NCT04392869|Behavioral|The CRAFT program (adapted due to COVID-19)|"The CRAFT program was created by P. Posadas, PhD (Posadas 2017). This program aims to cultivate positive emotions toward oneself and others, engaging socio-emotional processes and activating traits such as empathy, motivation and creativity. It has been previously implemented in other Higher Education Institutions (Rull et al 2019, Posadas 2018, 2019).
~It originally consists of 8 weekly classes, 2 hours each (18 hours direct instruction) but it has been adapted and extended due to the situation caused by the COVID19 pandemic.
~The resulting 12 week program is structured along the following topics: Consciousness, Relaxation-Breathing-Regulation, Mindfulness/Full Attention, Bliss, Transcendence, Communication as Connection, Mindfully, Consciously and Blissfully Living our Daily Lives, My Work of Art My Wonderful Craft Work Here and Now, Time and Energy Management, Passion and Compassion in the COVID context."
15806981|NCT04392869|Behavioral|The MBSR program (adapted due to COVID-19)|"The MBSR program is a group-based therapy which teaches mindfulness skills through a range of formal and informal mindfulness practices. Created by Kabat-Zinn (1982), in the current study it is taught by an officially accredited instructor and is compliant with the guidelines established by Brown University and the University of Massachusetts, USA.
~It originally consists of 8 weekly classes, 2 hours each (18 hours direct instruction) but it has been adapted and extended due to the situation caused by the COVID19 pandemic.
~The resulting 12 week program is structured along the following topics: The Underpinnings of MBSR, The Perception of Reality, Emotion Regulation, Understanding Stress: The Mind-Body Relation, Responding to Stress, Communication and Personal Relations, Daily Life Management, My Personal Plan: The First Week of the Rest of my Life, Time and Energy Management, Emotion Regulation in the COVID context."
15806984|NCT04392843|Other|Fasting|Subjects remain fasted prior to insulin-induced hypoglycemia.
15806985|NCT04392843|Other|Feeding|Subjects eat a normal breakfast and lunch prior to insulin-induced hypoglycemia.
15806986|NCT04392830|Drug|ALZ002 DS|Administered orally
15806987|NCT04392830|Drug|Placebo|Administered orally
15806988|NCT04392817|Behavioral|Arabic Articulatory Error Remediation software program|A speech therapy computerized intervention
15806989|NCT04392804|Procedure|scaling and root planing|one appointment for scaling and root planing of selected periodontal pockets, with periodontal curette (HuFriedy, Chicago, IL, USA), rinsing with saline solution
15806990|NCT04392791|Other|balneotherapy|Balneotherapy, a medical remedy, with medically and legally recognized mineral waters for therapeutic and rehabilitation purposes
15806992|NCT04392778|Biological|Saline Control|Saline will be given to patients positively, clinically and radiologically diagnosed with COVID-19, followed with 3 months observation.
15806994|NCT04392752|Other|Dieting intervention|This study includes four laboratory testing sessions over the 50-week period. Testing sessions will be performed over one week. Time points include testing before the diet or the control period start (PRE), one week before the competition (MID), after the competition (COMP) and after a recovery period (POST), during which the participants are advised to continue their normal training regimen, but to stop competition dieting. Participants will spend three hours in the laboratory between 0700-1300. The control group will be advised to maintain their normal physical activity diet throughout the study. The participants will be given identification numbers and the research group is blinded so that they do not know which group participants belong to. All measurements will be conducted at the same time (always within max ±1 hour) due to the importance of standardizing the time of the day of measurements.
15806995|NCT04392739|Drug|Tpoxx|oral antiviral
15806996|NCT04392713|Drug|Ivermectin 6 MG Oral Tablet (2 tablets)|12 mg single dose of Ivermectin will be given to intervention arm
15806997|NCT04392700|Drug|Tenofovir disoproxil fumarate 300mg|Take the medicine once a day ，300mg/d
15806998|NCT04392700|Drug|Entecavir 0.5 mg|Take the medicine once a day，0.5 mg/d
15806999|NCT04392674|Device|the new tissue containment system|using the new tissue containment system during Laparoscopic myomectomy morcellation
15807000|NCT04392661|Procedure|Laparoscopic Sleeve Gastrectomy|bariatric surgeries and data collection
15807001|NCT04392648|Drug|TAK-573|TAK-573 intravenous infusion.
15807002|NCT04392648|Drug|Pomalidomide|Pomalidomide capsules orally.
15807003|NCT04392648|Drug|Bortezomib|Bortezomib injection subcutaneously.
15807004|NCT04392648|Drug|Cyclophosphamide|Cyclophosphamide tablets orally.
15807005|NCT04392648|Drug|Dexamethasone|Dexamethasone tablets orally.
15807006|NCT04392635|Device|Trocar Placement Assist Device (TPAD)|The TPAD is an experimental device used to assist with placement of Veress needle and trocar during laparoscopic surgery.
15807007|NCT04392622|Drug|D-Limonene Gelcaps|Administered orally at 2 to 8 grams daily
15807008|NCT04392622|Radiation|Intensity modulated radiotherapy (IMRT)|Standard of Care -All patients will receive standard radiation treatment of 66 to 70 Gy given in 33 to 35 fractions (2 to 2.12 Gy/fractions) over 6.5 to 7 weeks.
15807009|NCT04392622|Drug|Cisplatin|Standard of Care -Cisplatin as 100 mg/m2 IV
15807010|NCT04392622|Other|Xerostomia questionnaire|Xerostomia questionnaire consists of 4 items on dryness while eating/speaking and 4 on dryness at rest. Patients rate each symptom on an 11 point ordinal Likert scale from 0 to 10, with higher scores indicating greater xerostomia
15807011|NCT04392596|Device|Bone Mineral Density and Trabecular Bone score|"structural damage in the cervical and lumbar spine was scored according to the modified Stoke AS Spinal Score (mSASSS) which yielded a final summation score ranging from zero to 72.
~BMD was measured using DXA (Lunar Prodigy densitometer, GE Healthcare, Madison, WI, USA).
~BMD was measured at the lumbar spine (L1-L4) and the left hip (femoral neck and total proximal femur).
~TBS was analyzed using DXA images over exactly the same region as the lumbar BMD assessment (L1-L4). Lumbar spine DXA images were reanalyzed using TBS iNight software version 2.1 (Med-I maps, Merignac, France). Patients were divided in 3 TBS groups according to guidelines for fracture risk [22]: any TBS >1.31 was considered as normal; TBS values between 1.23 and 1.31 were consistent as partially degraded structure; and any TBS <1.23 was considered as degraded structure."
15807012|NCT04392583|Device|ENTACT Septal Staple system|The ENTACT Septal Stapler delivers implantable septal staples which are intended to connect internal tissues to aid healing and for approximation of soft tissue during nasal septal surgery.
15807013|NCT04392570|Diagnostic Test|Fasting|blood samplings will be taken 08:00 am and again 2 hours before breaking the fast
15807014|NCT04392557|Drug|Metformin / alogliptin Oral Product|850 or 1000 mg/ 12.5 mg every 12 hours for 12 months
15807015|NCT04392557|Drug|Metformin / Pioglitazone Pill|(850 mg/15 mg every 12 hours) for 12 months
15807016|NCT04392557|Drug|triple therapy|Metformin / Alogliptin/ Pioglitazone
15807017|NCT04392531|Drug|Cyclosporine|In the experimental group, cyclosporine will be started according to patient weight, and then increased depending on patient tolerance (monitoring renal function and blood pressure)
15807018|NCT04392531|Drug|Standard treatment|Standard of care according to hospital protocol
15807019|NCT04392518|Other|exercise|Breathing, posture, dynamic core stabilization, upper and lower extremity strengthening exercises.
15807020|NCT04392505|Drug|Durvalumab Injection|Included patients will receive durvalumab (fixed dose, 1500mg Q4W) until progressive disease and no clinical benefit, intolerable toxicity or patient's wish, for a maximum duration of 12 months. Treatment with durvalumab should start <5 weeks after last radiotherapy dosing.
15807021|NCT04392492|Device|MANTA vascular closure device|Femoral access site closure using the MANTA closure device
15807022|NCT04392479|Drug|Aflibercept-FOLFIRI|Aflibercept-FOLFIRI
15807023|NCT04392479|Drug|Aflibercept-mFOLFIRI3|Aflibercept-mFOLFIRI3
15807024|NCT04392466|Other|walking on the treadmill|Participants will walk on the treadmill under single task, cognitive dual task and motor dual task conditions.
15807025|NCT04392453|Device|Robotic therapy|The treatment with the robot Icone will include 30 sessions, each session lasting 45 minutes, with a frequency from three to five times a week. The treatment will be provided in the patient's room. Patients will execute upper limb movement involving elbow flexion-extension, shoulder protraction-retraction, internal-external rotation, flexion-extension, and abduction-adduction. Visual and auditory feedback will be provided during the tasks. The exercises will train both motor and cognitive functions.
15807026|NCT04392440|Behavioral|DIAL-SDM|Communication intervention for nephrologists and coaching intervention for patients.
15807027|NCT04392440|Other|usual care|regular nephrology care
15807028|NCT04392427|Drug|Treatment group: will receive a combination of Nitazoxanide, Ribavirin and Ivermectin for a duration of seven days :|"Target population: any subject with COVID-19 PCR positive pharyngeal swab and referred to the above-mentioned quarantine without any comorbidities and no sensitivity or contraindication to the three drugs.
~Sample size: will depends on sequential analysis until a significant effect will be detected with a maximum of 100 subjects in each arm.
~Randomization: subjects will be allocated to either arm by block randomization method with sealed opaque envelops. Each block will include 10 subjects (to be allocated randomly as 5 in each group)
~Intervention:
~A) Treatment group: will receive a combination of Nitazoxanide, Ribavirin and Ivermectin for a duration of seven days"
15807029|NCT04392414|Biological|COVID-19 convalescent hyperimmune plasma|Subjects to receive double convalescent hyperimmune plasma units of 300 ml each, with the 2nd unit administered no later than 24 hrs after the first one
15807030|NCT04392414|Biological|Non-convalescent fresh frozen plasma (Standard plasma)|Subjects to receive double standard plasma units of 300 ml each, with the 2nd unit administered no later than 24 hrs after the first one
15807031|NCT04392401|Biological|Collection of blood samples in order to create a biocollection|Blood samples will be collected at admission in intensive care, at Day 3, Day 7, Day 12 and Day 20 during their hospitalization. Clinical data from routine care will be collected. Vital status will be assessed at Day 28 and Day 90.
15807032|NCT04392388|Biological|Non applicable|to collect data from questionnaires and to collect serological samples
15807033|NCT04392375|Drug|Nifedipine 30 MG|Nifedipine XL is a long-acting medication used to lower blood pressure. The investigators want to learn whether women who receive the study drug will experience fewer severe-range blood pressure readings, and therefore need fewer intravenous (IV) medications to safely lower blood pressure.
15807034|NCT04392375|Drug|Placebos|At the time of enrollment, patients will be randomized to either the study drug (oral Nifedipine XL 30mg) or identical placebo.
15807035|NCT04392362|Drug|Adenosine|A vial of adenosine with 6mg
15807036|NCT04392349|Device|Haag-Streit EYESTAR 900|The EYESTAR 900 is a new device developed by HAAG-STREIT AG which utilises Optical Coherence Tomography (OCT) for quantitative measurements of the geometry of the eye. As a successor to the LENSTAR 900, it represents the most recent in a series of successful biometry devices.
15807037|NCT04392349|Device|Tomey CASIA 2|The CASIA2 is a testing application for Cataract / Glaucoma / Cornea Surgery already established on the market. It is a representative device for measurement of anterior and posterior corneal curvature (anterior and posterior corneal topography) by optical coherence tomography, and for measurement of crystalline lens tilt by optical coherence tomography.
15807038|NCT04392349|Device|Oculus PENTACAM HR|The Pentacam HR is a high-resolution rotating Scheimpflug camera system for anterior segment analysis already established on the market. It is used as representative device for advanced anterior segment analysis such as anterior and posterior corneal topography and corneal pachymetry.
15807039|NCT04392349|Device|Zeiss ATLAS 9000|ATLAS is a corneal topography system used as representative device for measurement of anterior corneal curvature (anterior corneal topography).
15807040|NCT04392336|Other|Trust/Respect feedback|This feedback includes information on the level of trust/respect that a consumer has for their clinician in addition to symptom feedback.
15807041|NCT04392323|Diagnostic Test|COVID-19 PCR and Serology|PCR for COVID entails obtaining a nasopharyngeal swab (a cotton tip introduced via the nose to obtain a sample) to determine whether there is active viral replication and viral shedding. They will then have a second test with serology and PCR for COVID-19 infection 12-16 days after discharge from the hospital. Serology implies that a blood sample will be obtained by venipuncture. A volume of 50 ml (about 4 tablespoons) or less of blood will be obtained.
15807042|NCT04392297|Diagnostic Test|Bood leukocyte subsets|Determination of blood leukocyte subpopulations: myeloid suppressor cells, T-regulatory cells, T-cells according to the stages of differentiation (naive - effector - memory), activated T-cells; circulating endothelial cells
15807043|NCT04392297|Diagnostic Test|CMV specific T-cells|CMV specific T-cells detected by flow cytometry
15807044|NCT04392297|Diagnostic Test|serum CMV IgM / IgG antibodies|serum CMV IgM / IgG antibodies detected by ELISA
15807045|NCT04392284|Behavioral|Diet Counseling|"Delivery of nutrition counseling intervention to improve diet quality. Suggested energy intake will be prescribed with the intent to maintain energy balance and current body weight. A total of 16 nutrition counseling sessions lasting ~30 minutes will be scheduled with a frequency of 1 session per week for 1 month (5 sessions), 1 session every-other week for months 2-6 (11 sessions). Responding participants who have improved their insulin resistance as measured at the 8-week visit will continue receiving this level of nutrition counseling through the end of the study, meeting with the dietitian every other week. Starting at week 9, those identified as non-responding participants will be re-randomized to 2nd stage interventions, of either receiving nutrition counseling for weight loss (meeting with the dietitian every other week) or the addition of a prescription for metformin."
15807046|NCT04392284|Behavioral|Exercise Counseling|"Delivery of exercise counseling intervention to increase engagement in physical activity. The exercise specialist will counsel participants to progressively increase their weekly physical activity. Weight loss is not a primary goal of these exercise counseling sessions. A total of 16 exercise counseling sessions lasting ~30 minutes will be scheduled with a frequency of 1 session per week for 1 month (5 sessions), 1 session every-other week for months 2-6 (11 sessions). Responding participants who have improved their insulin resistance as measured at the 8-week visit will continue receiving this level of exercise counseling through the end of the study, meeting with the exercise specialist every other week. Starting at week 9, those identified as non-responders will be re-randomized to 2nd stage interventions, of either receiving nutrition counseling for weight loss (meeting with the dietitian every other week) or the addition of a prescription for metformin."
15807047|NCT04392271|Drug|LY3372689|Administered orally.
15807048|NCT04392271|Diagnostic Test|[18F]LSN3316612|Administered intravenously (IV).
15807049|NCT04392258|Diagnostic Test|TSH determination|Determination of serum concentration of thyrotropin (TSH)
15807050|NCT04392258|Diagnostic Test|FT4 determination|Determination of serum free thyroxine (FT4) concentration
15807051|NCT04392258|Diagnostic Test|FT3 determination|Determination of serum free triiodothyronine (FT3) concentration
15807052|NCT04392258|Diagnostic Test|SPINA-GT|Calculation of thyroid's secretory capacity (SPINA-GT)
15807053|NCT04392258|Diagnostic Test|SPINA-GD|Calculation of total deiodinase activity (SPINA-GD)
15807054|NCT04392232|Drug|Convalescent Plasma|"• Investigational Product
~o COVID-19 convalescent plasma will be obtained from an FDA-registered blood establishment (Hoxworth) that follows donor eligibility criteria and donor qualifications as outlined in section III.C.I of the Investigational COVID-19 Convalescent Plasma Guidance for Industry."
15807055|NCT04392219|Drug|EIDD-2801|"Part 1:
~Participants will be randomized to receive a single oral dose of EIDD-2801 or Placebo.
~Part 2:
~Two single oral doses of EIDD-2801 will be administered to participants, in an open-label manner.
~Part 3:
~Participants will be randomized to receive twice daily dosing either EIDD-2801 or Placebo."
15807056|NCT04392219|Drug|Placebo|"Part 1:
~Participants will be randomized to receive a single oral dose of EIDD-2801 or Placebo.
~Part 3:
~Participants will be randomized to receive twice daily dosing either EIDD-2801 or Placebo."
15807057|NCT04392206|Drug|Adipose Derived Mesenchymal Stem Cells|The dose will be specifically tailored to each subject's vascular anatomy determined by the surgeon through ultrasound measurements. Approximately 3-5 million cells in 5ml Ringer Lactate (RL) Solution
15807058|NCT04392193|Radiation|Proton Particle Therapy|Proton therapy will be delivered in a single fraction using the Probeat-V system
15807059|NCT04392180|Other|Qualitative Interview|There is no intervention as part of this study. Caregivers will participate in a qualitative interview over the phone or by video.
15807063|NCT04392141|Drug|Standard Treatment|Standard Treatment for COVID-19 based on National Recommendations
15807064|NCT04392141|Drug|Oral administration of Colchicine plus Herbal Phenolic Monoterpene Fractions|Colchicine plus a Herbal extraction containing a Phenolic Monoterpene Fractions will be added to standard treatment in patients with COVID-19.
15807065|NCT04392128|Drug|Hydroxychloroquine Sulfate 200 MG [Plaquenil]|Hydroxychloroquine is an anti-malarial drug also used as anti-inflammatory treatment for systemic lupus erythematosus and rheumatic disorders. HCQ also inhibits pH-dependant replication stages of diverse types of viruses including flavivirus, retrovirus and coronaviruses.
15807066|NCT04392128|Drug|Azithromycin 250 MG Oral Capsule|Azithromycin is amacrolide antibiotic.
15807067|NCT04392128|Drug|Placebo oral tablet|Placebo of Hydroxychloroquine Sulfate 200 MG [Plaquenil].
15807068|NCT04392128|Drug|Placebo oral capsule|Placebo of Azithromycin capsules.
15807069|NCT04392115|Behavioral|The PREPARE program|"A home-based exercise program guided by paper materials, weekly phone calls, and a DVD.
~Exercise will be prescribed as one-hour sessions, performed a minimum of three times per week for at least three months, consisting of: 1) strength training; 2) aerobic exercise and 3) flexibility."
15807070|NCT04392102|Drug|ZL-2306(Niraparib）|The starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count
15807071|NCT04392089|Device|Masimo, LidCO|"Near-infrared spectroscopy (NIRS), pulse oxymetry (saturation), continous hemoglobine, peripheral perfusion index (PPI) as measured with Massimo
~Systolic arterial pressure (SAP), diastolic arterial pressure (DAP), mean arterial pressure (MAP), stroke volume (SV), heart rate (HR), cardiac output (CO), systemic vascular resistance (SVR) as measured with LiDCO"
15807072|NCT04392076|Procedure|Image Guided Ablation|Image Guided Ablation with RFA, MWA or CRYO of Renal Cancer
15807073|NCT04392063|Drug|Melatonin 3 mg|The children received crushed Melatonin 3-mg tablets daily, 30-minutes before bedtime for 3-months.
15807074|NCT04392050|Other|Interview|Complete interview
15807075|NCT04392050|Other|Focus Group|Attend focus groups
15807076|NCT04392050|Other|Questionnaire Administration|Ancillary studies
15807077|NCT04392037|Drug|Iberdomide plus low-dose cyclophosphamide and dexamethasone|Iberdomide, low dose Cyclophosphamide and Dexamethason will be given until progression or unacceptable toxicity
15807078|NCT04392024|Device|Triumf|Triumf is intraocular lens which offers multifocal vision by extended depth of focus and diffractive optics.
15807079|NCT04392011|Drug|Midazolam HCl|Oral syrup, 2 mg/mL
15807080|NCT04392011|Drug|Dextromethorphan HBr|Oral liquid capsules, 15 mg
15807081|NCT04392011|Dietary Supplement|Kratom|Kratom (Moon Kratom Yellow Indonesian, lot 51) is supplied as a dry leaf powder in clear plastic bags, each weighing 5 kg. Two g of kratom dry leaf powder will be stirred into 240 mL of hot water to make a tea. The tea will be cooled to 50 degrees Celsius before administration. Subjects will drink the tea within 10 minutes of administration.
15807082|NCT04391998|Drug|Iron Supplement|oral tablet twice daily after meals
15807083|NCT04391998|Drug|Metronidazole Oral|500 mg oral twice daily
15807084|NCT04391998|Drug|Albendazole|200 mg oral single dose
15807085|NCT04391985|Drug|SOF plus (OBV/PTV/r) plus RBV|They were given SOF in a dose of 400 mg/day, and a fixed dose combination of OBV (25 mg), PTV (150 mg), and r (100 mg) taken with food once daily. RBV was supplied in 200 mg capsules, and the recommended dose was 600 mg/ day to reach 1200 mg/day based on patient's body weight and tolerability.
15807086|NCT04391972|Device|SAV|SAV multifocal intraocular lens is a implantable IOL which offers multifocal vision.
15807087|NCT04391959|Drug|AZR-MD-001 Active|AZR-MD-001 is an active ophthalmic ointment
15807088|NCT04391959|Drug|AZR-MD-001 Vehicle|AZR-MD-001 is a vehicle ophthalmic ointment
15807089|NCT04391946|Behavioral|Data registry|Collection of clinical data, treatment regimens and survival data
15807090|NCT04391933|Diagnostic Test|MRI 3 tesla|MRI of colon cancer. Sensitivity, specificity, positivity predictive values and negative predictive values are calculated form the histopathological surgical specimen. This will be the endpoint for both CT and MRI.
15807091|NCT04391920|Device|CytoSorb 300 mL device|CytoSorb hemoadsorption provided via integration of the CytoSorb device into ECMO, CRRT, or hemoperfusion extracorporeal circuits.
15807092|NCT04391907|Procedure|IPL|Intense pulse light (IPL) laser is used for the treatment of dry eye originated from meibomian gland dysfunction. IPL laser will be performed to patients who are planned to cataract surgery to improve dry eye.
15807093|NCT04391894|Drug|ECF843|Topical ocular eye drop
15807094|NCT04391894|Other|ECF843 vehicle|Topical ocular eye drop
15807095|NCT04391868|Drug|Viagra Tablet|50 mg tablet on Day 1 of each period
15807096|NCT04391868|Drug|Sildenafil Citrate ODF|50 mg ODF on Day 1 of each period
15807097|NCT04391868|Drug|Sildenafil Citrate ODF|50 mg ODF on Day 1 of each period
15807098|NCT04391855|Drug|Tramadol with ropivacaine|A solution of tramadol 2mg/kg with ropivacaine hydrochloride (10mg/ml) 100mg mixture making up a total volume of 15ml will be infiltrated in the surgical trauma area before closure.
15807099|NCT04391855|Drug|Dexmedetomidine with ropivacaine|A solution of dexmedetomidine 1μg/kg with ropivacaine hydrochloride (10mg/ml) 100mg mixture making up a total volume of 15ml will be infiltrated in the surgical trauma area before closure.
15807470|NCT04388488|Device|CONNECT TF adaptable socket system|Prefabricated, adaptable socket system
15807100|NCT04391855|Drug|Magnesium with ropivacaine|A solution of magnesium 10 mg/kg with ropivacaine hydrochloride (10mg/ml) 100mg mixture making up a total volume of 15ml will be infiltrated in the surgical trauma area before closure.
15807101|NCT04391855|Drug|Ropivacaine plus normal saline|A solution of ropivacaine hydrochloride (10mg/ml) 100mg with 5ml of isotonic saline 0.9% mixture making up a total volume of 15ml will be infiltrated in the surgical trauma area before closure.
15807102|NCT04391842|Combination Product|Sustained Acoustic Device with 1% Diclofenac patch|"Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2 with 1% diclofenac patch
~Other Names:
~ZetrOZ ultrasound device
~wearable ultrasound device
~long duration ultrasound
~LITUS device
~long duration low intensity device"
15807103|NCT04391829|Diagnostic Test|Ejaculated semen sample|SARS-CoV-2 positive men will be asked to give an ejaculated semen sample, within the seven days after positive testing. Semen samples will be performed every 7 days, until 2 semen PCR tests are negative and will be retested after 3 months.
15807104|NCT04391803|Device|Pipeline™ Flex Embolization Device with Shield Technology™|The Pipeline™ Flex Embolization Device with Shield Technology™ is intended for endovascular treatment of adults with intracranial acutely ruptured aneurysms not amenable to clipping and coiling.
15807105|NCT04391790|Procedure|Cystectomy and modified urinary conduit|The modified retrosigmoid conduit is extended aorund 5 cm, so the left ureter does not have to cross under the mesentery wheras the presumed more robust ileal segment does.
15807106|NCT04391790|Procedure|Cystectomy and standard urinary conduit ad modum Bricker|The conduit is constructed using approximately 15 cm of terminal ileum and placed in the right side of the abdomen. In order for the left ureter to reach the conduit, it is mobilized behind the sigmoideum to the conduit.
15807107|NCT04391777|Other|Fourth ventricle compression technique (CV-4)|The participant is in the supine position and the principal investigator is seated at the patient's head, with elbows resting on the table. The main investigator overlaps his hands with the thenar eminences, contacting the occipital bone squamous part, between the external occipital protuberance and the participant's occipito-mastoid suture. The technique begins with a maintained compression on the occipital squamous part during a deep thorax exhalation. Throughout the compression of the occipital bone and the participant's voluntary inspirations, the principal investigator feels a gradual pressure increase at the thenar eminences. The technique will be performed until reaching the still point, in which the mobility of the occipital bone, respiratory rate and muscle tone decrease, or until 5 minutes elapsed.
15807108|NCT04391777|Other|Sham|The main investigator uses the technique contact but does not perform any type of tissue traction or compression, maintaining this contact for 5 minutes. At the end of the stipulated time, the contact is removed in a subtle way.
15807109|NCT04391764|Drug|Naltrexone|Naltrexone at a dose of 50 mg per day
15807110|NCT04391764|Drug|Placebo oral tablet|Placebo tablets will be identical in size, colour, shape, and taste and will be given in the similar manner.
15807111|NCT04391751|Procedure|Carpal tunnel release and basal joint arthroplasty through single incision|Group I: experimental - single incision The surgical technique chosen for thumb basal join was trapeziectomy with ligamentous reconstruction and tendon interposition (LRTI), using flexor carpi radialis (FCR). Through a dorsal approach over trapeziometacarpal joint, the entire trapezium was excised. Volar traction of FCR allowed us to longitudinally incise the deep leaflet of FCR tendon until flexor pollicis longus (FPL) tendon was clearly visualized. Then, ulnar half of FCR tendon was harvested proximally through a second transverse incision in middle third of the forearm and split all the way to its insertion on the index metacarpal. A hole was placed in the base of the first metacarpal and FCR tendon was routed through the bone canal and then fixed with non-reabsorbable sutures. Finally, the tendon remanent was rolled up and placed into the trapezial void to act as a spacer.
15807112|NCT04391751|Procedure|Carpal tunnel release and basal joint arthroplasty through double incision|Group II: active comparator - double incision Trapezial excision and ligament reconstruction were performed in the same way as in group I, except that FCR deep leaflet was not incised. After radial incision wound closure, carpal tunnel release was performed through a second separate longitudinal palmar incision.
15807113|NCT04391738|Other|Patients admitted to Intensive Care Unit with SARS-CoV2|Patients admitted to Intensive Care Unit with SARS-CoV2
15807114|NCT04391725|Procedure|Periapical surgery with guided tissue regeneration|periapical surgery will be done followed by placement of mixture of iPRF and type 1 collagen granules
15807115|NCT04391725|Procedure|Periapical surgery without anyguided tissue regeneration|periapical surgery will be done followed by flap closure
15807116|NCT04391712|Device|MLS Laser|Treatments will be delivered to the participants days 1-4, in a prone position using a 10 by 25 cm laser field across each lung with 7j/cm2 at 1500 Hz.
15807117|NCT04391712|Other|Regular Inpatient Medical Care|Regular inpatient medical care
15807118|NCT04391699|Device|heated humidification|heated humidification system
15807119|NCT04391686|Diagnostic Test|indirect calorimetry|to determine and compare the resting energy expenditure of each group
15807120|NCT04391673|Behavioral|Vestibular rehabilitation|Vestibular rehabilitation (treatment as usual).
15807121|NCT04391660|Drug|0.5% sodium hypochlorite solution|Disinfection with a 0.5% sodium hypochlorite solution applied with a sterile compress. This same antiseptic will be used at each dressing change.
15807122|NCT04391660|Drug|0.5% sodium hypochlorite solution and 70% ethanol|Disinfection with a 0.5% sodium hypochlorite solution applied with a sterile compress preceded by an application of 70% ethanol with a sterile compress, for its immediate bactericidal action. 0.5% sodium hypochlorite solution will be applied once the alcohol has evaporated and the skin is visually dried. These same antiseptics will be used at each dressing change.
15807123|NCT04391647|Other|First-void urine collection|"One time collection of ca. 20 ml of first-void urine with the Colli-PeeTM device (Novosanis) during visit at the Centre for the Evaluation of Vaccination.
~IF HPV positive and the woman gave consent to be contacted again: Collection of ca. 20 ml of first-void urine with the Colli-PeeTM device (Novosanis) each day during 14 days (n = 14)"
15807124|NCT04391647|Other|Blood draw|- One time blood sample collection (5-10 cc) by a study nurse of Centre for the Evaluation of Vaccination.
15807125|NCT04391634|Other|volume guarantee|volume guarantee assist-control mechanical ventilation
15807126|NCT04391634|Other|pressure-controlled|pressure-controlled assist-control mechanical ventilation
15807127|NCT04391621|Procedure|Autologous Adipose Derived stem cell transplantation|Through liposuction, harvested lipoaspirate will be processed in theatre through centrifugation at 1200g, then the sediment will be washed with Phosphate buffered saline and then incubated at 37 degrees celsius in 0.075% Collagenase type 1a for 1 hour. This will then be washed in an equal volume of 10% Fetal Bovine Serum then filtered through a 100 micrometer cell strainer. Red cells lysed using the Red cell lysis buffer will be performed followed by washing in Phosphate buffered Saline and centrifugation and the stromal vascular fraction cell pellet collected and diluted into 5ml normal saline solution for inflitration. This will then be infiltrated into the affected keloid.
15807128|NCT04391621|Drug|Triamcinolone Acetonide 40Mg/Ml Inj,Susp_#1|Triamcinolone Acetanoide 40mg/ml suspension will be diluted into 1ml of 0.5% lignocaine solution and infiltrated into the selected keloid.
15807129|NCT04391608|Drug|Switching to Tenofovir Alafenamide|Switching from Tenofovir Disoproxil Fumarate to Tenofovir Alafenamide
15807130|NCT04391595|Drug|Abemaciclib|100 mg of Abemaciclib BID for 11 doses over 5.5 days prior to surgical resection. Participants with tumors demonstrating PK-response in Phase 0 will continue treatment with recommended Phase 2 dose (RP2D) continuously in 21d cycles after surgery.
15807131|NCT04391595|Drug|LY3214996|400 mg of LY3214996 daily for 6 doses over 5.5 days prior to surgical resection. Participants with tumors demonstrating PK-response in Phase 0 will continue treatment with recommended Phase 2 dose (RP2D) continuously in 21d cycles after surgery.
15807132|NCT04391582|Other|Tilapia skin|After cleaning the lesion with tap water and 2% chlorhexidine gluconate, the tilapia skin was applied and covered with gauze and bandage. These dressings were changed only if the tilapia skin did not adhere properly to the wound bed
15807133|NCT04391582|Drug|silver sulfadiazine cream 1%|After cleaning the lesion with tap water and 2% chlorhexidine gluconate, a thin layer of silver sulfadiazine cream 1% was applied and covered with gauze and bandage. In these patients, the dressings were changed daily
15807134|NCT04391569|Drug|Ganaxolone|Double-blind study that will randomize subjects to ganaxolone or placebo in 1:1 ratio.
15807135|NCT04391569|Drug|Placebo|Double-blind study that will randomize subjects to ganaxolone or placebo in 1:1 ratio.
15807136|NCT04391556|Drug|Firmagon|120 mg subcutaneous Injection of Firmagon after a TEP-PSMA
15807137|NCT04391543|Other|Experimental session|"comprehensive interview
~cognitive tests
~anthropometric measures
~postural balance test
~critical force test
~Astrand-Ryhming test
~self-questionnaire (QLQ-C30, FA12, Brief Cope et Hospital Anxiety and Depression Scale)
~actimetry
~clinical and biological characteristics
~determination of inflammatory markers
~skeletal muscle index"
15807138|NCT04391530|Behavioral|emotional freedom technique, breathing therapy|emotional freedom technique, breathing therapy
15807139|NCT04391517|Diagnostic Test|SpHb measurement|All included patients will have their Hb measured non-invasively by a trained health care provider. SpHb values will be recorded in the documentation software already in use at the clinic.
15807140|NCT04391504|Procedure|LAAC combined with radiofrequency ablation group|Each patient received the same group of patients with simple radiofrequency ablation radiofrequency ablation treatment at the same time, the transcatheter occlusion of left atrial appendage opening
15807141|NCT04391491|Diagnostic Test|Neuregulin-1β level in plasma|Peripheral blood will be collected after randomization (plus or minus 3 days), the plasma will be assayed for neuregulin-1b, biomarkers of inflammation and fibrosis, NTproBNP
15807142|NCT04391478|Drug|Milrinone|milrinone lactate, 1mg/ml, for intra venous use only
15807143|NCT04391478|Drug|Sildenafil|50mg sildenafil citrate/tablet, crushed in water taken by nasogastric tube
15807144|NCT04391465|Other|Electrophysiological Pacing|Assess the MCA CBF velocity response at different paced heart rates.
15807145|NCT04391452|Dietary Supplement|Stress Resist® (oral dietary supplement)|Stress Resist® (dietary supplement) is composed of Mg (150 mg), Vitamin B6 (0.7 mg), Vitamin B9 (100µg), Vitamin B12 (1.25 µg), rhodiola (222mg), and green tea/L-théanine (125 mg). Oral supplementation. All subjects in the MAGRITTE study will receive either a dietary supplement or a placebo for 28 days (morning intake). The effects on stress will be studied both with questionnaires, biological samples (blood, urine and stool), with a Heart Rate Variability test. 40 subjects (20 subjects per group) will have an fMRI exam.
15807146|NCT04391439|Drug|Intravenous Methylprednisolone|
15807147|NCT04391413|Device|Use of OCT to guide the angioplasty procedure|OCT will be performed and OCT data used to choose and/or modify procedural strategy. The OCT system used will be the Ilumien Optis system, and Dragonfly Optis probe.
15807148|NCT04391400|Diagnostic Test|nasal pharyngeal (NP) swab samples|These donors will be from a population of patients who are already providing nasal pharyngeal (NP) swab samples in universal transport media (UTM) for COVID-19 testing at LabPMM LLC.
15807149|NCT04391400|Diagnostic Test|peripheral blood draw|"From patients suspected of SARS-CoV-2 viral infections.
~At least 2mL to 5mL of peripheral blood.
~Collected in EDTA tubes.
~Shipped to ambient LabPMM, LLC within 2 days.
~Specimen Collections:
~Collected at the same time as the NP specimen sent for COVID-19 testing.
~Collected two to three weeks post the original patient's COVID-19 testing."
15807150|NCT04391387|Procedure|prone position|a position with the patient lying face down with arms bent comfortably at the elbow and padded with the armboards positioned forward
15807151|NCT04391374|Procedure|an arterial reconstructive procedure|
15807152|NCT04391361|Drug|Scopolamine, atropine, edaravone and dexmedetomidine|The patients were treated with scopolamine, atropine, edaravone and dexmedetomidine dissolved in saline.
15807153|NCT04391361|Drug|Edaravone|The patients was treated with edaravone dissolved in the same volume of saline as the intervention applied in the experimental group.
15807154|NCT04391348|Radiation|PET-TDM with 18F-FDG + PET-TDM with 18F-fluorocholine|Experimental procedure combining PET-TDM with 18F-FDG and PET-TDM with 18F-Fluorocholine
15807155|NCT04391309|Biological|anti-CD14|4 mg/kg on Day 1, 2 mg/kg on Days 2-4 administered intravenously (IV)
15807156|NCT04391309|Other|Placebo|Placebo administered intravenously on Days 1-4
15807157|NCT04391309|Drug|remdesivir|Remdesivir administered intravenously for 5 days beginning with a 200 mg loading dose on Day 1, followed by 100 mg/day on Days 2-5.
15807186|NCT04391036|Device|High Eudragit® Content Vaginal Film|High (12.8%) Eudragit® Content Vaginal Film
15807187|NCT04391036|Device|Low Eudragit® Content Vaginal Film|Low (6.4%) Eudragit® Content Vaginal Film
15807158|NCT04391296|Procedure|Arm I (Prepectoral), Arm II (Subpectoral)|"Arm I (Prepectoral)De-epithelialized skin flaps are made from the inferior pole of breast skin and soft tissue. The implant pocket is shaped by fixing a sufficiently large amount of ADM to the medial surface of the mastectomy pocket, the upper edge of the pectoralis major muscle and the de-epithelial skin flap. The implant is located in the prepectoral mastectomy pocket and the ADM anchored to the chest wall, serratus fascia, and de-epithelial skin flaps. The pectoralis major muscle is located in the anatomical location behind the ADM.
~Arm II (Subpectoral)The pectoralis major muscle is dissected from the thorax to create sufficient space for the implant to be placed behind the pectoralis major muscle. Implant pockets are made by suturing the lower part of the elevated pectoralis major muscle to the top of the de-epithelial skin flap and the ADM patch to the skin flap, the pectoralis major muscle, and the lateral thoracic fascia."
15807159|NCT04391283|Drug|Osimertinib|The recommended dose is 80 mg osimertinib once a day until disease progression or unacceptable toxicity according to the prescription information and clinical practice. It can be taken with or without food at the same time each day.
15807160|NCT04391270|Behavioral|blended intervention|A blended intervention group combining the web-based components with face-to-face workshops and posters
15807161|NCT04391270|Behavioral|web-based intervention|A web-based intervention only referred to the use of internet without traditional face-to-face workshops and posters
15807162|NCT04391257|Device|geko™|Assess if cardiac pacemakers detect geko™ electrical output pulse.
15807163|NCT04391231|Drug|Pentoxifylline Oral Product|Blinded Pentoxifylline (in suspension with SyrSpend SF)
15807164|NCT04391231|Drug|Placebo|Placebo (SyrSpend SF only)
15807165|NCT04391218|Other|Multidisciplinary Approach Group|Geriatricians will introduce medication review data on a Clinical Decision Support System, that will help both pharmacists and physicians in medication reconciliation, highligting potentially inappropriate prescriptions according to Beers' criteria and STOPP/START criteria, and potential controindicated and major Drug-Drug Interactions according to Micromedex. Before Hospital at Home discharge, nurses will instruct patients and/or caregivers to the use of an App, where daily drug therapy at discharge will be inserted and scheduled. This App will automatically create an alert everytime a drug dose needs to be taken, alongside an image of the specific drug packaging. The App will register if and when the patient actually takes the drug, or the reason for the delayed/missed dose.
15807166|NCT04391192|Behavioral|Virtual Overdose Response|All participants will be provided the phone number and encouraged to call when they use alone.
15807167|NCT04391179|Drug|Dipyridamole 100 Milligram(mg)|Drug will be given for 14 days while in the hospital.
15807168|NCT04391179|Drug|Placebo oral tablet|Placebo will be given for 14 days while in the hospital.
15807169|NCT04391166|Other|Non invasive visual acuity testing|This will be visual acuity at home and visual acuity in clinic both using an ETDRS chart.
15807170|NCT04391153|Procedure|ERCP with tissue sampling|Patients with biliary strictures undergo ERCP o EUS. Tissue specimens obtained via either of brush cytology, forceps biopsy or fine needle aspiration during ERCP or endosonography (EUS) were examined by routine cytology or histology methods. In addition, FISH inlcuding fluorescence-based polynucleotide probes targeting chromosomes 3, 7, 17 and locus 9p21 was performed. Gold standard for final diagnosis is the histology from surgical resection. In patients without surgery, a follow up of 12 months will be considered adequate to exclude or confirm malignant etiology.
15807171|NCT04391140|Other|Prone position|HFNC set to a SpO2 of 90-95% combined with prone position. At least 2 sessions of 30 minutes or more will be performed daily.
15807172|NCT04391127|Drug|Hydroxychloroquine|Hydroxychloroquine: 400 mg PO every 12 hours for one day. Subsequently 200 mg every 12 hours per 4 more days.
15807173|NCT04391127|Drug|Ivermectin|Ivermectin 12 mg PO every 24 hours for one day (in case of weight less than 80 kg) or 18 mg PO every 24 hours for one day (in case of weight over 80 kg) Subsequently this group will take two tablets of placebo 12 hrs after ivermectin ingestion and then one tablet of placebo each 12 hrs per 4 more days.
15807174|NCT04391127|Drug|Placebo|Two tablets of placebo PO every 12 hours for one day. Subsequently one tablet of placebo every 12 hours per 4 more days.
15807175|NCT04391114|Procedure|Traditional HoLEP|Holmium laser enucleation of the prostate (HoLEP), first reported by Fraundorfer et al in 1998, is a more recent step in the evolution of holmium laser prostatectomy. HoLEP is a safe and effective procedure which has demonstrated comparable results to TURP and open prostatectomy for patients with symptomatic enlarged prostate, with low morbidity and short hospital stay [4]. The improvement in outcome parameters is durable, and the late complications and reoperation rates reported are very low [5]. HoLEP is equally suitable for small, medium and larger prostate glands, with clinical outcomes that are independent of prostate size, unlike TURP. HOLEP offers patients the alterative of being treated endoscopically with minimal blood loss, short catheterization time, and decreased hospital stay [6].
15807176|NCT04391114|Procedure|Top-Down HoLEP|The main difference between the Top-Down and Traditional approach is that the direction of lateral dissection begins from upwards to downwards. This could help in avoiding the overtraction of the mucosal strip overlying the posterior urethral sphincter, which theoretically leads to a decrease in the incidence of postoperative stress incontinence. Moreover, using the Top-Down approach should lead to a decrease in the incidence of lost enucleation planes, which results in decreasing the intraoperative time and decreasing the number of cases required to master the HoLEP technique.
15807177|NCT04391101|Drug|Convalescent plasma|400-500ml convalescent plasma
15807178|NCT04391088|Other|vaccine coverage assessment|vaccine coverage assessment
15807179|NCT04391075|Procedure|Pudendal nerve block|Pudendal nerve block provided during last fase of delivery
15807180|NCT04391062|Drug|Gliolan|patient will receive 5-ALA 4 to 6 hours before surgery
15807181|NCT04391062|Device|Intraoperative PDT|"The protocol requires the realization of specific procedures in addition to the usual care.
~The intra-operative photodynamic therapy (intraoperative PDT) added to surgery for glioblastoma excision. The patient will receive 5-ALA ( 5-aminolevulinic acid hydrochloride),GLIOLAN drinkable 6h before surgery + lighting of the tumor bed by a red light source (laser with different J/cm²) at the end of resection (Prolonged surgery of 45 minutes)."
15807182|NCT04391049|Drug|Carboplatin|Given IV
15807183|NCT04391049|Drug|Paclitaxel|Given IV
15807184|NCT04391049|Radiation|Radiation Therapy|Undergo radiation therapy
15807185|NCT04391049|Biological|Telomerase-specific Type 5 Adenovirus OBP-301|Given by intratumoral injection
15807188|NCT04391023|Device|Sham Transcranial Direct Current Stimulation (tDCS)|tDCS is a non-invasive brain stimulation technique in which a very weak electrical current (2 mA) is applied to the scalp at the beginning of the session and then remains at 0 mA for the duration of the session to control for placebo-like effects. The anode and cathode will both be placed over the cerebellum.
15807189|NCT04391023|Behavioral|Balance Training|The balance training protocol will include balance training exercises on both compliant (i.e., foam pad and trampoline) and firm surfaces.
15807190|NCT04391023|Device|2 mA Transcranial Direct Current Stimulation|tDCS is a non-invasive brain stimulation technique in which very weak electrical current (2 mA) is applied to the scalp for 20 minutes. The anode and cathode will both be placed over the cerebellum.
15807191|NCT04391023|Device|4 mA Transcranial Direct Current Stimulation|tDCS is a non-invasive brain stimulation technique in which very weak electrical current (4 mA) is applied to the scalp for 20 minutes. The anode and cathode will both be placed over the cerebellum.
15807192|NCT04391010|Other|Surgical masks|Surgical masks will be applied in health care providers
15807193|NCT04391010|Other|Filtering respirators|Filtering respirators will be applied in health care providers
15807194|NCT04390997|Procedure|Non-surgical Periodontal Treatment|Non-surgical periodontal treatment includes scaling and root planning by using curettes and ultrasonic devices only in the periodontitis group.
15807195|NCT04390984|Drug|Apatinib Mesylate, Gefitinib|Subjects will be administrated with 500mg apatinib on day 1 and day 12-15, and administrated with gefitinib on day 4-15.
15807196|NCT04390971|Biological|ET-01|Recruited participants will receive ET-01 IV infusion after conditioning.
15807197|NCT04390958|Drug|nab-paclitaxel|125mg/m2 ivgtt d1、d8
15807198|NCT04390958|Drug|Cisplatin|60mg/m2 ivgtt d1 or d1-2
15807199|NCT04390958|Drug|Capecitabine|1750mg/m2 po bid d1-14
15807200|NCT04390945|Drug|Camrelizumab|Camrelizumab combined with concurrent radiotherapy and chemotherapy
15807201|NCT04390932|Other|Enhanced TA|The enhanced TA is characterized by the personalization of the conversation, the verbalization of a joint participation in the process, the full presence of the therapist in the development of the exercise protocol, and the inclusion of behaviors such as active listening, empathy, and encouragement. In addition, therapist's body language transmits confidence, security, and attention.
15807202|NCT04390932|Other|Limited TA|The limited TA does not consider the personalization of the conversation, uses a unidirectional verbalization and is imperative about the instructions provided to the participant, the therapist is intermittently absent during the therapeutic exercise sessions and uses a neutral or negative nonverbal language cues.
15807203|NCT04390932|Other|Therapeutic exercise protocol.|Three 45-60 minute sessions of supervised therapeutic exercise (combination of aerobic, isometric, and isotonic exercise) delivered within a one-week period.
15807204|NCT04390919|Other|elevated monocyte count|The monocyte count at admission was higher than 0.445×10*9 cells/L
15807205|NCT04390893|Device|ultrasound|Anesthesiologist would scan three planes of the neck to position the LMA
15807206|NCT04390893|Diagnostic Test|air leakage test|Anesthesiologist would use air leakage test to position the LMA
15807207|NCT04390880|Drug|18F-DCFPyL|Study participants will receive intravenous administration of 18F-DCFPyL and undergo a PET/CT imaging study. Patients may be reenrolled in the study, if 18F-DCFPyL PET/CT is performed for subsequent management decision.
15807212|NCT04390854|Biological|Blood clot scaffold|"Bleeding will be induced in the canal by passing a size 30 sterile K-file 3 mm beyond the apex with the goal of having the entire canal filled with blood to the level of the cemento-enamel junction. Bleeding will be stopped just below the cemento enamel junction.
~Biodentine will be placed approximately 3-4 mm below the cementoenamel junction."
15807213|NCT04390854|Biological|Blood clot scaffold combined with PRF|Platelet-rich fibrin will be prepared by drawing the patient blood into a 10mL test tube without the addition of an anticoagulant. To prevent the blood from coagulating after coming in contact with the glass tube, it will be centrifuged immediately using a table top centrifuge** at 400 g force for 12 minutes. Then platelet-rich fibrin membrane will be placed into the canal space to a level 3 mm below the cemento-enamel junction using hand plugger following the induction of apical bleeding by passing a number 30 sterile hand file 3 mm beyond the apex of the tooth. Biodentine cap will be placed over the platelet-rich fibrin scaffold.
15807214|NCT04390841|Device|Cardiac Stimulator|The subjects will receive the intracardiac electrophysiological examination, during which the subjects will be subject to diagnostic electrical stimulation by the Qubic Stim Cardiac Stimulator. The subjects will also receive the clinical follow-up visit after cardiac electrical stimulation until they are discharged from the hospital.
15807215|NCT04390828|Behavioral|Guided Imagery Meditation|the guided image meditation invention program of the intervention measures of this study include four important elements: 1) Meditation exercises: the exercises to adjust the body and mind through specific attention, so that people gradually feel the state of relaxation through practice; (2) Guided image: the simple visualization and use of mental images produced by imagination as a form of psychotherapy, images come from natural scenes (e.g., forests and mountains, streams and oceans), positive feelings and emotions are generated through psychological imagination to induce psychological and physiological relaxation state; (3) Music aids: reaching a relaxed state with comfortable and slow background music; (4) Breathing relaxation training: the patient is taught to take abdominal breathing to divert attention and stimulate the parasympathetic nervous system to achieve muscle relaxation. The entire intervention process takes about 15 to 20 minutes, 2 times a day.
15807216|NCT04390815|Drug|Insulin|Adding insulin to conventional wound treatment
15807293|NCT04390217|Drug|Placebo|Placebo is delivered orally/enterally, 700 mL per day split into two administrations of 350 mL, approximately 12 hours apart, for up to 7 days.
15807294|NCT04390204|Other|intervenions|"Motor control exercises
~A supervised home self-rehabilitation program"
15807217|NCT04390802|Drug|5-aminolevulinic acid|Study participants who are deemed surgical candidates for management of their pituitary lesion will drink 20mg/kg 5-ALA 2-4 hours preoperatively. They will then be taken to the operation room and undergo general anesthesia. Intraoperative blood draw may occur from lines places for anesthesia purposes at any time during the operation. In alignment with the neurosurgeon's practice and discretion, the sella will be accessed and opened. During the surgical exploration of the sella, the surgeon will attempt to identify the pituitary mass. The location of the tumor will be assessed using the blue-light filtered microscope or endoscope. These steps will be documented photographically during the operation. A biopsy of the fluorescent region will be taken to confirm pituitary adenoma histopathology. The tumor will then be maximally resected. The tumor sample will be used for further clinical testing as part of the patient's routine care.
15807218|NCT04390789|Procedure|Non surgical Single visit Retreatment|Non-surgical endodontic retreatment will be carried out in single visit.
15807219|NCT04390789|Procedure|Multi visit Retreatment with calcium hydroxide dressing|In this group,GP removal and biomechanical preparation will be carried out in first visit,after which calcium hydroxide dressing will be placed and temporarily restored.after 7 days,in second visit obturation will be done followed by permanent restoration
15807220|NCT04390776|Drug|PF-06651600|PF-06651600 100 milligrams (mg) will be provided as Tablets and Capsules.
15807221|NCT04390763|Biological|NIS793|anti-TGFb antibody
15807222|NCT04390763|Biological|Spartalizumab|anti-PD-1 antibody
15807223|NCT04390763|Drug|gemcitabine|SOC chemotherapy
15807224|NCT04390763|Drug|nab-paclitaxel|SOC chemotherapy
15807226|NCT04390737|Drug|HH2853 Tablets|Proposed daily dose (BID): 50mg, 100mg, 200mg, 400mg, 600mg, 800mg, 1000mg. It is possible for additional and/or intermediate dose levels to be added during the course of the study. Cohorts may be added at any dose level below the MTD in order to better understand safety, PK or PD.
15807227|NCT04390724|Other|Y90 radioembolization|Patients with HCC who are eligible to receive standard-of-care Y90 radioembolization and are hepatic resection candidates with inadequate future liver remnant
15807228|NCT04390711|Other|High density lipoprotein isolation, detection and in-vitro study.|All blood samples were taken on the day of cardiac catheterization after overnight fasting.High density lipoprotein from each participants was isolated and further collected for carbamylation level detection and in-vitro study.
15807229|NCT04390698|Procedure|paravertebral block|Paravertebral block will be performed at T2,T4 level on the surgical side using out-of-plane approach under ultrasound-guided, with 0.4% ropivacaine 20ml at each injection site.
15807230|NCT04390698|Drug|opioid free anesthesia|propofol, lidocine and muscle relaxant will be used for induction, after laryngeal mask airway insertion, general anesthesia will be maintained.
15807231|NCT04390698|Procedure|sham block|Local infiltration at the same site of paravertebral block will be performed, with 1% lidocaine 3ml on each injection site.
15807232|NCT04390698|Procedure|opioid general anesthesia|propofol, sufentanil and muscle relaxant will be used for induction, after laryngeal mask airway insertion, general anesthesia will be maintained .
15807233|NCT04390685|Drug|Tacrolimus ointment|Treatment with tacrolimus ointment once daily for one year following axillary lymph node dissection
15807234|NCT04390672|Device|SUPRAFLEX Cruz|Percutaneous Coronary Intervention for multivessel disease
15807235|NCT04390672|Device|SYNERGY|Percutaneous Coronary Intervention for multivessel disease
15807236|NCT04390659|Procedure|myomectomy|The myomectomy was done by conventional technique but timing of myomectomy either before or after delivery of the baby varied between different cases .Infusion of oxytocin during the operation and for 24 h later.
15807237|NCT04390646|Drug|GnRH, gonadorelin acetate|Drug administered by a subcutaneous pump during 24 weeks, at a dosage of 75 ng/kg/pulse giving a pulse every 90 minutes in women and every 120 minutes in men.
15807238|NCT04390646|Drug|0.9% NaCl|Drug administered by a subcutaneous pump during 24 weeks, at a dosage of 75 ng/kg/pulse giving a pulse every 90 minutes in women and every 120 minutes in men.
15807239|NCT04390620|Device|Mucosal Closure|mucosal closure in oral surgery (mucosal sutures)
15807240|NCT04390607|Diagnostic Test|leukocyte esterase electrochemical assay|A sample of blood drawn for routine standard of care laboratory assessments will be used to also test the new electrochemical assay. This is a validation study and the results of the electrochemical assay will not be used to treat patients
15807241|NCT04390594|Drug|Nafamostat Mesilate|"Nafamostat mesilate continuous intravenous injection. Daily dose ranging between 0.1 mg/kg/h and 0.2 mg/kg/h, based on the severity and underlying disease of the clinical trial participant.
~Administration for 10-14 days based on the severity and underlying disease of the clinical trial participant"
15807242|NCT04390581|Device|Juvéderm® VOLIFT with Lidocaine|Consists of one injection of Juvéderm® VOLIFT with Lidocaine to both hands no more than 6ml for both hands total on Day 1. Optional on Day 30.
15807243|NCT04390568|Drug|BI 655130|BI 655130
15807244|NCT04390542|Behavioral|Psychoeducation|"6 sessions (in-person, videoconference, or phone delivery per the caregiver's choice) between the interventionist and caregivers. Topics covered in sessions include:
~Session 1: Communication, Support, Self Care, Symptom Management
~Sessions 2-4: Communication, Symptom Management, Support
~Sessions 5-6: Self-Care, Symptom Management, Communication, Support, Future Planning"
15807245|NCT04390529|Other|quality-of-life questionnaire: BREAST-Q|quality-of-life questionnaire: BREAST-Q
15807246|NCT04390516|Device|COViage|The COViage machine learning algorithm is designed to predict mechanical ventilation and mortality within 24 hours after hospital admission.
15807247|NCT04390503|Biological|Convalescent Plasma (anti-SARS-CoV-2 plasma)|Convalescent Plasma that contains antibody titers against SARS-CoV-2.
15807248|NCT04390503|Biological|Control (albumin 5%)|Albumin (Human) 5% is a sterile aqueous solution for intravenous use containing the albumin component human plasma.
15807249|NCT04390490|Device|Graphene quantum dots combined with Si nanowire photoelectrochemical immunosensor|Graphene quantum dots combined with Si nanowire is a new method of photoelectrochemical immunosensor
15807250|NCT04390477|Dietary Supplement|Probiotic|Oral daily capsule containing probiotic strains with maltodextrin as excipient, administrated for 30 days.
15807390|NCT04389294|Diagnostic Test|SARS-CoV2 serum antibody testing|Participants will have SARS-CoV2 serum antibody testing performed twice within 4 months of each other.
15807251|NCT04390464|Drug|Ravulizumab|Ravulizumab (Ultomiris, Alexion Pharmaceuticals) is a monoclonal antibody that binds to terminal complement protein C5 and prevents the complement-mediated destruction of cells. It is administered by intravenous infusion. Ravulizumab has a marketing authorisation in the UK for treating Paroxysmal Nocturnal Haemoglobinuria in adults.
15807252|NCT04390464|Drug|Baricitinib|Baricitinib is administered orally once daily. It is licensed for treatment of rheumatoid arthritis, it is a relatively fast acting disease modifying anti-rheumatic drug and has the potential to be scaled up for use for a pandemic.
15807253|NCT04390464|Other|Standard of care|Regular standard of care for COVID-19 patients
15807254|NCT04390451|Behavioral|Whole Health STEPS|A peer-delivered package of Whole Health services.
15807255|NCT04390438|Procedure|Percutaneous Electrolysis|Needle emplacement with a galvanic electrical current
15807256|NCT04390438|Procedure|Dry needling|Needle emplacement without electrical current nor substance
15807257|NCT04390425|Device|Experimental - Limb Occlusion pressure|This intervention involves lower tourniquet pressure than the standard of care. There is no change to tourniquet time or how the surgery is performed.
15807258|NCT04390412|Radiation|Low Dose Radiotherapy|0.5 Gy radiation to both lungs in an AP/PA treatment plan
15807269|NCT04390360|Procedure|Protective ventilation implementation|In this condition, we will implement the protective ventilation related with gender and height . A blood gas will be performed at before protective ventilation implementation and at the end of this condition.Time condition 30 minutes
15807270|NCT04390360|Procedure|Protective ventilation with HME|In this condition, the patient will received protective ventilation with a Heat Moisture Exchanger (HME). A blood gas will be performed at the end of this condition.Time condition 30 minutes
15807271|NCT04390360|Procedure|Protective ventilation with Heated humidifier|In this condition, the patient will received protective ventilation with a Heated humidifier. A blood gas will be performed at the end of this condition.Time condition 30 minutes
15807272|NCT04390360|Procedure|Tidal Volume reduction|n this condition, we will reduce Tidal volume (with smartphone application calculation) to obtain the same alveolar ventilation (PaCO2) obtained on the HME condition
15807273|NCT04390347|Dietary Supplement|Yakult|A fermented milk product with live microorganisms.
15807274|NCT04390347|Dietary Supplement|Placebo|A milk product with no live microorganisms.
15807275|NCT04390334|Drug|Daridorexant|Daridorexant will be administered orally as 1 film-coated tablet of 50 mg strength to be taken in the morning under fasted conditions.
15807276|NCT04390334|Drug|Famotidine|Famotidine will be administered orally as 1 film-coated tablet of 40 mg strength to be taken in the morning under fasted conditions.
15807277|NCT04390334|Drug|Efavirenz|Efavirenz will be administered orally as 1 film-coated tablet of 600 mg strength o.d. in the evening.
15807278|NCT04390321|Other|LLMcare|Participants will undergo 20 sessions of computerized cognitive and physical training, during a 2 month period. Both components have a duration of 30 minutes and are consecutive, but their sequence is pseudo-randomized. All sessions are conducted under supervision. Cognitive training uses the greek adaptation of the BrainHQ software (Posit Science Corporation), utilizing audiovisual stimuli, and targets memory, attention, cognitive-processing speed, orientation and social skills. Physical training is based on the WebFitForAll protocol and uses the motion sensor device Kinect. It consists of warm-up, aerobic, flexibility, strength, balance and cool down exercises.
15807282|NCT04390295|Drug|Placebo|Once daily, 24 weeks
15807283|NCT04390295|Drug|SHR3824|Once daily, 52 weeks
15807284|NCT04390295|Drug|metformin|Three times daily, 52 weeks
15807285|NCT04390282|Behavioral|Application-based support system|All participants (experimental and control group) will be invited to a separate appointment at the vascular open clinic at baseline and after three months and measured regarding weight, blood pressure, Ankle Brachial Pressure Index, six minutes walking test and pain. To calculate the estimate 10-year risk of manifesting clinical cardiovascular disease, the Framingham Risk Score will be used. Further, a questionnaire will be answered at baseline and after three months containing the instruments, VascuQoL-6, Health Education Impact Questionnaire and Medication Adherence Report Scale-5.
15807286|NCT04390256|Other|Clove water extract|natural product
15807287|NCT04390256|Other|Carbopol|Bioadhesive polymer
15807288|NCT04390256|Other|Carboxymethyle cellulose|Bioadhesive polymer
15807289|NCT04390243|Drug|Binimetinib|Given PO
15807290|NCT04390243|Drug|Encorafenib|Given PO
15807291|NCT04390230|Procedure|Penile prostheses implantation|Penial implantation with either Coloplast or Boston Scientific - AMS IPPs between 2014 and 2019, by 2 surgeons of the University Hospital of Nice, France
15807292|NCT04390217|Drug|LB1148|LB1148 is delivered orally/enterally, 700 mL per day split into two administrations of 350 mL, approximately 12 hours apart, for up to 7 days.
15807295|NCT04390191|Device|Continuous Positive Airway Pressure|CPAP at fixed pressure (8-10cm H20) for 72 hours continuously (except for daily activities such as eating, personal activities and breaks for ambulation etc).
15807296|NCT04390178|Biological|SARS-CoV-2 convalescent plasma|Treatment with convalescent plasma (180-200ml) from individuals who have recovered from SARS-CoV-2 infection
15807297|NCT04390165|Other|Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances|This is an online patient-reported questionnaire that examines the presence or absence of olfactory and taste disturbances, the onset of olfactory and taste disturbances in relation to other COVID-19 symptoms, and the temporal evolution of the severity of olfactory and taste disturbances. The occurrence of ear symptoms in COVID-19 infection will also be evaluated in this questionnaire as a secondary outcome. The questionnaire will also have questions relating to the patient's underlying health conditions, risk factors for COVID-19 infection, and demographics.
15807298|NCT04390152|Drug|Wharton's jelly derived Mesenchymal stem cells.|IV Wharton's jelly derived Mesenchymal stem cells, two doses
15807299|NCT04390152|Drug|Hydroxychloroquine, lopinavir/ritonavir or azithromycin and placebo (standard therapy)|Standard therapy as per hospital protocol, hydroxychloroquine 400mg + Lopinavir/Ritonavir 400/100 or azithromycin 500mg and Placebo
15807300|NCT04390139|Drug|XCEL-UMC-BETA|Administration on top of the standard administered treatment
15807301|NCT04390139|Other|Placebo|Administration on top of the standard administered treatment
15807302|NCT04390126|Other|life questionnaires|Telephone survey during the confinement period (common questionnaire and a questionnaire specific to the patient's pathology)
15807303|NCT04390126|Other|questionnaire|1-year telephone diary to identify complications resulting in hospitalization related to the patient's chronic disease
15807304|NCT04390113|Biological|ALVR105 (Viralym-M)|Administered as 2-4 milliliter infusion, visually identical to placebo
15807305|NCT04390113|Biological|Placebo|Administered as 2-4 milliliter infusion, visually identical to ALVR105 (Viralym-M)
15807306|NCT04390100|Drug|hyaluronic acid (Gengiegel 0.2% oral gel )|coverage of the free gingival graft area in the palate
15807307|NCT04390100|Other|Platelet rich fibrin|coverage of the free gingival graft area in the palate
15807308|NCT04390100|Other|Gel foam|coverage of the free gingival graft area in the palate
15807309|NCT04390087|Other|Exercise|Upper-body rowing performed while participants are sitting in their own wheelchair.
15807310|NCT04390074|Other|COVID-19 and Intensive Care|No intervention, observational.
15807311|NCT04390061|Drug|Tofacitinib|Jak-1/3 inhibitor
15807312|NCT04390061|Drug|Hydroxychloroquine|Standard Therapy
15807316|NCT04390035|Device|Blood Flow Restriction using Delfi Personalized Tourniquet System|Participants assigned to the test group will undergo blood flow restriction training 2 days per week beginning at week 1-2 post-surgery and continuing through week 16 post-surgery using the FDA-approved Delfi Personalized Tourniquet System (PTS) with personalized pressure of 80% of the limb occlusion pressure (LOP). The LOP is the amount of pressure required to fully occlude arterial and venous blood flow to the limb. Otherwise, both the test group and control group will follow a standard 6-month post-surgery rehabilitation protocol which is standard of care for ACLR recovery.
15807317|NCT04390022|Drug|Ivermectin|Single dose of STROMECTOL® tablets at 400mcg/kg
15807318|NCT04390022|Drug|Placebo|Placebo tablets will not match ivermectin but they will be administered by staff not involved in the clinical care.
15807319|NCT04390009|Diagnostic Test|Entire-body PET-CT scans|Entire-body PET-CT scans will be performed with state-of-the-art scanners with different manufacturers' models including Siemens Biograph Vision, United Imaging uEXPLORER and possibly other recently FDA-approved PET-CT scanners.
15807320|NCT04390009|Drug|Amyvid radiopharmaceutical|Amyvid (F18-florbetapir) will be evaluated for binding to white matter of the peripheral and central nervous system of participants
15807321|NCT04389996|Other|No intervention|Patients will be sent a survey incl. EORTC QLQ-C30
15807322|NCT04389983|Dietary Supplement|Medium Chain Triglyceride oil|Bulletproof Braine Octane MCT oil
15807323|NCT04389970|Behavioral|Time Restricted Feeding|Participants will eat all food within an 8 hour window each day. They will only consume water or black coffee during the remaining 16 hours.
15807324|NCT04389944|Other|convalescent plasma application to SARS-CoV-2 infected patients|In addition to standard of care, SARS-CoV-2 infected patients for whom blood group compatible convalescent plasma is available and who are willing to sign the informed consent receive convalescent plasma as follows: 200ml at enrolment and 200ml at 12-24 hours follow-up.
15807325|NCT04389931|Other|Lactose tab|Two tablets containing lactose Procedure: Periodontal treatment Scaling and root planning
15807326|NCT04389931|Drug|Omega 3|Two tablets containing 1g Omega 3. Procedure:Periodontal treatment Scaling and root planning
15807327|NCT04389918|Other|Tality|Synthetic meal replacements, delivered in many varieties of 400 kCal packets, Manufacturer: Filtricine, Inc.
15807328|NCT04389905|Behavioral|Dental education - Motivational Interviewing|Motivational Interviewing - Focusing on oral/dental health
15807353|NCT04389684|Other|Psycho-Social Questionnaire|Patients, after enrollmenet in the study, receive a paper questionnaire during the month following COVID19 related confinement and all the material to send it back to the institution. They receive the same questionnaire 3 months later with all the material to send it back to the institution. The intervention is the same for all patients wether their treatment was modified or not.
15807329|NCT04389892|Diagnostic Test|Contrast enhanced harmonic endoscopic ultrasound|"During the echoendoscopy the image was fixed on the region of interest (pancreatic cyst) and the extended pure harmonic detection mode was selected. 2,4ml contrast enhancement (Sonovue-Bracco Italy) was injected in the right antecubital vein of the participants followed by a flush of 5ml 0.9% saline solution to ensure that the entire quantity of the agent goes in to the blood flow.
~After the administration the pancreatic cyst was observed for at least 120 seconds.We followed the enhancing behavior of the cyst wall, the septa and the solid components. Arterial enhancement (contrast uptake) was considered the first 25-30 seconds after injection and the venous phase (wah-out) 30-45 seconds after injection.
~EUS-FNA was performed in all patients without contraindications"
15807330|NCT04389879|Other|Bonding of either CAD/CAM or conventional multistranded stainless steel fixed retainer|Investigate and compare the clinical effectiveness of two types of fixed retainers; CAD/CAM vs. multistranded wire.
15807331|NCT04389866|Device|JUVÉDERM VOLUMA™ XC|Injectable gel
15807332|NCT04389853|Procedure|Flexible ureteroscopy|Retograde intrarenal surgery (RIRS) has gained much popularity especially when the role of SWL, in management of LPS, has been significantly diminished in the few last years5. RIRS is dependent mainly on flexible ureteroscopy (fURS). fURS increases the quality and performance of upper urinary tract exploration, allowing for the treatment of the majority of stones at all sites. Moreover, it is associated with no risk of renal parenchymal injuries and a very low risk of bleeding.
15807333|NCT04389853|Procedure|Mini-percutaneous nephrolithotomy|PCNL has regained popularity thanks to the possibility of using reduced calibers and modern technology, which has reduced the complications without compromising the stone clearance, and more efficient intracorporeal lithotripter modalities. However, PCNL is still a challenging surgical technique and can be associated with significant complications that may compromise its efficacy. In the present time, we have available calibers ranging from 4.8 to 30 French. Many reports advocate that morbidity after PCNL may be reduced by recent modifications, such as mini-PCNL (miniperc). One meta-analysis of mini-PCNL and conventional PCNL demonstrated that mini-PCNL had a greater safety profile with similar stone free rates (SFRs).
15807334|NCT04389840|Drug|Dociparstat sodium|Dociparstat is a glycosaminoglycan derived from porcine heparin.
15807335|NCT04389840|Drug|Placebo|0.9% Normal Saline
15807336|NCT04389814|Diagnostic Test|Biochemical markers|Multiple biomarkers of myocaridial ishemia will be obtained serially to calculate thier time of their release according to their release kinetics
15807337|NCT04389801|Drug|Desferal 500 MG Injection|iron chelating agent
15807338|NCT04389788|Device|carboxy therapy|6 sessions of carboxy therapy every 2 weeks
15807339|NCT04389788|Device|Dermapen with topical glutathione|6 sessions of Dermapen microneedling with topical glutathione every 2 weeks
15807344|NCT04389762|Dietary Supplement|daily ingestion of Lactobacillus plantarum PS128|daily ingestion of 60 billion colony forming unit (CFU) of Lactobacillus plantarum PS128 (30 billion CFU/capsule)
15807345|NCT04389749|Device|CPM|CPM-continuous passive motion device.
15807346|NCT04389736|Behavioral|Sitting|Participants sat in a chair with back, arms and legs supported.
15807347|NCT04389736|Behavioral|Standing|Participants were asked to stand with arms supported and feet spaced approximately 15 cm apart. If needed, adjustment of standing posture was allowed during standing trial to prevent orthostatic hypotension.
15807348|NCT04389736|Behavioral|Self-selected maximal intensity of neuromuscular electrical stimulation|Small electrodes placed (5*5 cm) on the lower limb of both legs. The instruction for NMES intensity was that the maximal intensity participants were be able to withstand for 2 hours whilst imagining sitting at home watching TV without feeling discomfort.
15807349|NCT04389723|Dietary Supplement|Qualia Mind|Multi-ingredient Dietary supplement
15807350|NCT04389723|Dietary Supplement|Placebo|Multi-ingredient Placebo
15807351|NCT04389710|Drug|Convalescent Plasma|One to two units (200-600 mL) of ABO compatible COVID-19 convalescent plasma
15807352|NCT04389697|Dietary Supplement|Clear fluids and food up to up to 1 hour before the procedure|Clear fluids and food up to up to 1 hour before the start of the procedure
15807354|NCT04389671|Drug|Lucinactant|Lucinactant administered as a liquid at a dose of 80 mg total phospholipids (TPL)/kg lean body weight delivered
15807355|NCT04389645|Diagnostic Test|IP-10 in CDS protocol|Dynamic IP-10 measurements in hospitalized COVID-19 positive patients
15807357|NCT04389619|Device|Fractional Microneedling Radiofrequency|In every patient, each one of the two scars, or each side of a large scar will be assigned to fractional microneedling radiofrequency. Fractional microneedling radiofrequency parameters; Power: 6 v, Exposure time: 800 ms. Depth: 2.5 mm (using non-insulated micro-needles), Frequency: 2 Hz for 5 treatment sessions 4 weeks apart.
15807358|NCT04389619|Procedure|Intralesional Steroid Injection with and without Microneedling|In every patient, each one of the two scars, or the other side of a large scar will be assigned to intralesional steroids injection, Triamcinolone acetonide will be injected in concentration 1:2 (20 mg/dl) using insulin syringe. o Scars treated with intralesional steroids will be subgrouped into two groups, one group treated with only intralesional steroids and the other group treated with intralesional steroids and followed by microneedling. Microneedling will be done using the same tip of the fractional microneedling radiofrequency at same depth. Patients will receive 5 treatment sessions 4 weeks apart.
15807359|NCT04389606|Other|Study Formula (SF)|New infant formula for term infants fed ad lib
15807360|NCT04389606|Other|Comparator Formula (CF)|Commercially available infant formula for term infants fed ad lib
15807361|NCT04389580|Drug|Drug: Isotretinoin plus Tamoxifen|"20 mg PO (by mouth) twice daily for 14 days
~13 cis retinoic acid (0.5 mg/kg/day in 2 divided doses orally for 14 days starting after three days of taking tamoxifen"
15807362|NCT04389580|Drug|Aerosolized Isotretinoin plus Tamoxifen|"20 mg PO (by mouth) twice daily for 14 days
~Aerosolized 13 cis retinoic acid in gradual in 2 divided doses increases froms 0.2 mg/kg/day to 4 mg/kg/day as inhaled 13 cis retinoic acid therapy for 14 days starting after three days of taking tamoxifen"
15807363|NCT04389567|Drug|Famotidine|Use of oral Famotidine.
15807364|NCT04389554|Other|Blood D-dimer assay|Blood samples will be taken from the patients and will be examined by the ELISA method.
15807365|NCT04389528|Other|Neuromodulation by tDCS|The tDCS is a device for modulating cortical excitability. It consists of passing a low intensity direct electrical current over the scalp via two electrodes: an anode and a cathode soaked in a saline solution. Although there is a short-circuit effect through the scalp, a significant amount of electrical current enters the brain and changes the transmembrane potential.
15807366|NCT04389502|Device|CaPtyVa app|The apps stores all the current local Clinical practice guidelines information related to CRC screening and surveillance and through its decision algorithms assist physicians in the screening process. In the screening function, CaPtyVa helps the physicians to classify patient´s according to their individual CRC risk and to determine how and when to start with screening tests. In the surveillance, function the app assist the physician in determining when to repeat the next colonoscopy according to guideline recommendation
15807367|NCT04389502|Other|Control group|current physician knowledge on local current CRC screening and surveillance guidelines
15807368|NCT04389476|Other|Standardized crisis management and coping protocol plan toward Coronavirus disease 2019 (COVID-19)|"Establish standardized crisis management and coping protocol plan toward Coronavirus disease 2019 (COVID-19) for the different tiers of medical staff, patients, and community residents.
~Then explore the psychological impact and mental disabilities under the intervention and controlling related factors."
15807369|NCT04389463|Other|No intervention|No description
15807370|NCT04389450|Biological|PLX-PAD|PLX-PAD, allogeneic ex vivo expanded placental mesenchymal-like adherent stromal cells
15807371|NCT04389450|Biological|Placebo|Placebo solution for injection
15807372|NCT04389437|Procedure|Ophthalmological exam|OCT-A and AO
15807373|NCT04389437|Procedure|Blood pressure measurement|Blood pressure measurement before the ophthalmological exam
15807374|NCT04389424|Drug|Tamoxifen|Use of tamoxifen for breast cancer recurrence prevention
15807375|NCT04389424|Drug|Exemestane|Use of exemestane for breast cancer recurrence prevention
15807376|NCT04389424|Drug|Anastrozole|Use of anastrozole for breast cancer recurrence prevention
15807377|NCT04389424|Diagnostic Test|Basal|Initial diagnosis of breast cacner by biopsy or mastectomy
15807378|NCT04389424|Diagnostic Test|Recurrence|Breast cancer recurrence under endocrine therapy
15807379|NCT04389411|Drug|Montelukast 10mg|10mg oral Montelukast will be taken daily for 60 days
15807380|NCT04389398|Device|pocket compression fixation belt|Pocket compression fixation belt to is used to compress the postoperative wounds of CIEDS patients, and its effect of preventing hematoma is evaluated.
15807381|NCT04389385|Biological|COVID-19 Specific T Cell derived exosomes (CSTC-Exo)|The virus-specific T-cells (VSTs) are body's natural immune defense against various disease-causing viruses. Donor originated COVID-19 specific T-cells (CSTC) are in vitro activated and expanded by exposing to viral peptide fragments in the presence of natural immune stimulant proteins called cytokines. These Covid-19 specific fragment peptides activate specific T-cells and stimulate the secretion of potent mediators including IFN gamma in forms of exosomes. We propose treatment of Covid-19 patients -who are at early stages of pulmonary disease- with CSTC-exomes to control disease progression.
15807382|NCT04389372|Behavioral|Mindfulness|Mindfulness by smartphone combined to video calls for clinical evaluation in patients with chronic migraine and medication overuse after withdrawal program
15807383|NCT04389359|Drug|Hydroxychloroquine Sulfate 200 MG|Hydroxychloroquine Sulfate administered orally for a maximum of 6 months. Doses population specific.
15807384|NCT04389346|Procedure|Periapical surgery using autologous platelet aggregate|PRF will be placed over the denuded root surface, following apicoectomy and before flap repositioning
15807385|NCT04389346|Procedure|Periapical surgery without autologous platelet aggregate|Flap will be repositioned following apicoectomy directly without placing any platelet aggregate
15807386|NCT04389333|Device|non-contact magnetically-controlled capsule endoscopy|The novel non-contact magnetically-controlled capsule endoscopy (MCE) system (Ankon Technologies, Wuhan, China) (Figure 1) added a remote control workstation and an audio-visual exchange system to the original well-establish MCE system, which consisted of a robotic magnetic arm, a workstation (currently bypassed) and a capsule endoscope.
15807387|NCT04389320|Drug|Hydroxychloroquine|assess its role in the coarse of covid 19 virus infection
15807388|NCT04389307|Other|Electrical stimulation (IVES)|IVES sessions were performed three times in a week, for 8 weeks. Every session lasted 20 minutes. The intervention comprised a 24 session treatment program of IVES.
15807389|NCT04389307|Other|Bladder Training|Bladder Training
15807436|NCT04388917|Procedure|Patial nephrectomy|Partial nephrectomy assisted with robot to remove kidney cancer
15807391|NCT04389281|Combination Product|X-PACT|X-PACT is comprised of a phosphor device, the drug methoxsalen sterile solution and X-ray energy. The dose of methoxsalen sterile solution per injection will vary per patient and will remained fixed across injections within each patient as it is based on the applicable tumor volume at baseline. Immediately after each injection of the combination product, patients will be exposed to an X-ray beam delivered via a LINAC (and thus targeted at the tumor) at a fixed dose to activate the combination product.
15807392|NCT04389268|Diagnostic Test|Visual Event-Related Potentials|Auditory P300-evoked brain potential: an eventrelated potential of cognitive neurophysiological significance. It represents the brain response to certain sensory/cognitive stimuli by paying attention to the different stimulus among the stereotypical ones (the auditory oddball paradigm). It measures mainly the decision-making process (Polich and Kok, 1995).
15807393|NCT04389255|Other|Star Excursion Balance Test|The Star Excursion Balance Test (SEBT) is a dynamic test that requires strength, flexibility, and proprioception. It is a measure of dynamic balance that provides a significant challenge to athletes and physically active individuals. The test can be used to assess physical performance, but can also be used to screen deficits in dynamic postural control due to musculoskeletal injuries (e.g. chronic ankle instability), to identify athletes at greater risk for lower extremity injury, as well as during the rehabilitation of orthopeadic injuries in healthy active adults.[
15807394|NCT04389255|Device|Balance Master device|The Balance Master (Neurocom International, Inc Clackamas,) device is a computerized posturography device. The device consists of a fixed support surface consisting of a force table and individuals, a variety of ground elements and a computer screen that will provide visual feedback and conduct test protocols. Posturography tests a person's ability to integrate visual, vestibular and somatosensory inputs and suppress inappropriate sensory information. Thus, it can quantitatively score the person's balance and examine balance problems in detail with the tests it contains. There are various protocols that evaluate balance differently in Balance Master (BMc). Limits of Stability Test (LOS) and Modified Clinical Test of Sensory Interaction in Balance (mCTSIB) were used in the BMc.
15807395|NCT04389242|Other|REST Online（Reduce Stress Tour Online）|Different cognitive behavioral skills are introduced and practiced in a 8 weekly online program, which includes animation briefing and debriefing, case demonstration video, exercise, forum, internal messaging, online assessment and reminder. One face-to-face session and one telephone follow-up provided by an experienced CBT therapist are also provided to clients.
15807396|NCT04389229|Drug|cyclophosphamide|600mg/m2/day for 3 days ( on day -5, -4, -3)
15807397|NCT04389229|Drug|fludarabine|30mg/m2/day for 3 days ( on day -5, -4, -3)
15807398|NCT04389229|Drug|IL-2 (Proleukin)|Subcutaneous injections at a fixed dose of 18 million units once a day following TIL infusion
15807399|NCT04389229|Genetic|Unmodified Tumour Infiltrating Lymphocytes (UTIL-01)|Single dose at 5 x 10^9 - 5 x 10^10
15807400|NCT04389229|Genetic|Gene modified Tumour Infiltrating Lymphocytes (CoTIL-01)|Single dose at 2 x10^9 (+/- 20%) (engineered TIL)
15807401|NCT04389216|Device|Cool-tip electrode for Radiofrequency Ablation|Radiofrequency ablation of the tumour in the surgery group, associated whith axillary surgery when applicable
15807402|NCT04389203|Procedure|Unilateral tubal disconnection + Spontaneous follow up for pregnancy|Unilateral tubal disconnection + Spontaneous follow up for pregnancy
15807403|NCT04389203|Procedure|Unilateral tubal disconnection + ICSI|Unilateral tubal disconnection + ICSI
15807404|NCT04389190|Other|Fluoroscopy settings for image acquisition|X-ray radiation is routinely used for imaging in coronary cath labs. Intervention involves lowering patient and operators X-ray exposure by employing various setting on the fluoroscopy machine.
15807405|NCT04389177|Drug|Pembrolizumab Injection [Keytruda]|"Neoadjuvant period:preoperative therapy with three cycles: Pembrolizumab 200mg D1; Paclitaxel 135mg/m2 D2; Cisplatin 20mg/m2 D2-D4; repeated every 3 weeks.
~Da Vinci robot radical surgery: Before surgery, head/abdomen/chest CT scan, type B ultrasonic, upper gastrointestinal contrast, endoscopic ultrasound (EUS), and gastroscopy with biopsy will be done. Surgery should be done within 4-6 weeks after last neoadjuvant treatment finished.
~Adjuvant period: Adjuvant treatment with pembrolizumab 200mg every 3 weeks (6 cycles) should be performed within 3-6 weeks after surgery if the surgical pathology result is not pCR. abdomen/chest CT scan will be performed every 3 month after surgery."
15807406|NCT04389164|Procedure|Tissue-engineered skin grafts of autologous scar dermal scaffolds|"scar excision. The thickness of scar tissue in the middle of scar is removed with a roller cutter and the thickness is about 0.01 -- 0.02mm.
~take autologous skin slices of the patient with an electric skin knife, cut out a small piece of skin, and prepare autologous epidermal basal cell suspension for use;The rest of the skin should be the same size as the wound.
~the prepared autogenous scar dermal stent was grafted onto the scar resection wound surface, and the prepared autoepidermal basal cells were sprayed between the mesh and on the dermal stent, and autologous skin slices were grafted onto the wound surface and fixed with pressure bandaging;
~after the operation, the outer dressing should be changed regularly according to the conventional treatment, and the wound surface condition should be observed and recorded according to the experimental scheme."
15807407|NCT04389151|Drug|Toripalimab|Toripalimab union CAPEOX scheme： Toripalimab 240mg, ivgtt, Q3w Oxaliplatin 130mg/m2,ivgtt, Q3w capecitabine 1000mg/m2, p.o Q3w
15807408|NCT04389138|Other|Physiotherapy Intervention|Physiotherapy intervention will include an assessment to identify individual areas that physiotherapy should target. Intervention will be based on the core areas recommended by the European Physiotherapy Guideline for Parkinson's Disease: physical capacity (muscle power, tone, joint range of movement, exercise tolerance and pain), transfers, manual dexterity, balance and gait. Posture is incorporated as part of these 5 core areas. The intervention will be delivered over 4 visits.
15807409|NCT04389125|Dietary Supplement|Angelica Gigas Nakai and Allium Cepa L.Extract Mixtures|One packet once a day, after breakfast, for 12 week
15807410|NCT04389125|Dietary Supplement|Placebo|Placebo for 12 week
15807411|NCT04389112|Other|biopsy|Skin biopsies will be performed according to standard practices in the usual aseptic conditions, the operator wearing sterile gloves. A circular knife 3 mm will be used. Procedure interventions do not involve a drug or a device.
15807437|NCT04388904|Drug|Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (FDC)|Participants will receive Symtuza®. An oral tablet containing Darunavir 800 mg /Cobicistat 150 mg /Emtricitabine 200 mg /Tenofovir Alafenamide 10 mg FDC, once daily within 24 hours of the screening/ baseline visit.
15807471|NCT04388488|Device|Any conventional handmade socket|Subjects current socket
15807412|NCT04389086|Drug|Combination drug|"Induction chemotherapy consists of either three three-weekly cycles of CAPOX (oxaliplatin 130 mg/m2 BSA IV + capecitabine 1000 mg/m2 BSA, orally, twice daily) or four two-weekly cycles of FOLFOX (85 mg/m2 BSA of oxaliplatin IV + 400 mg/m2 BSA of leucovorin IV + 400 mg/m2 BSA of bolus 5-fluorouracil IV followed by 2400 mg/m2 BSA of continuous 5-fluorouracil IV). It is left to the discretion of the treating medical oncologist which of the two will be administered. In case of (previous) unacceptable toxicity (physician's discretion) to oxaliplatin, FOLFIRI may be prescribed. FOLFIRI (180 mg/m2 BSA of irinotecan IV + 400 mg/m2 BSA of leucovorin IV + 400 mg/m2 BSA of bolus 5-fluorouracil IV followed by 2400 mg/m2 BSA of continuous 5-fluorouracil IV) consists of four two-weekly cycles.
~If a patient has stable or responsive disease, induction chemotherapy will be continued with either one three-weekly cycle of CAPOX or two two-weekly cycles of FOLFOX/FOLFIRI."
15807413|NCT04389086|Radiation|Chemoradiotherapy|"Concomitant chemotherapy agent: capecitabine
~Radiotherapy dose: full course radiotherapy consists of 25x2.0 or 28x1.8 Gy. In case of previous radiotherapy, the radiotherapy dose will consist of 15x2.0 Gy."
15807414|NCT04389086|Procedure|Surgery locally recurrent rectal cancer|"Type of surgery depends on the location of the recurrence and involvement of adjacent structures and is left to the discretion of the operating surgeon.
~Intraoperative radiotherapy is optional."
15807415|NCT04389073|Drug|Vinorelbine 40mg|Two tablets per day, three times a week. Vinorelbine will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
15807416|NCT04389073|Biological|Toripalimab 240mg|Toripalimab 240 MG IV infusion every 3 weeks. Toripalimab will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
15807417|NCT04389073|Biological|Bevacizumab 15 mg/kg|Bevacizumab 15 mg/kg IV infusion every 3 weeks. Bevacizumab will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
15807418|NCT04389073|Drug|Cyclophosphamide 50 mg|50 mg per day. Cyclophosphamide will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
15807419|NCT04389073|Drug|Capecitabine 500Mg Oral Tablet|500mg three times a day. Capecitabine will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
15807420|NCT04389073|Drug|Cisplatin|Cisplatin 50mg/m2 IV infusion every 3 weeks. Cisplatin will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
15807421|NCT04389060|Dietary Supplement|Grape seed extract|Two capsule grape seed extract (total 600 mg)
15807422|NCT04389034|Drug|Pollinex Quattro with tree- and grass pollen extracts and their mixtures|retrospective analysis of patient records of allergen-specific immunotherapy
15807423|NCT04389021|Device|Virtual Reality|"The VR goggles have a 2560×1440 5.5 (538ppi) fast-switching LCD screen with standard 60Hz refresh, overclocked 72Hz refresh, running Android 7.1.2 Nougat with a Quad-core Qualcomm Snapdragon 821 (two 2.3GHz Kryo HP cores and two 2.15GHz Kryo cores). Adreno 530 as GPU. It is 190 x 105 x 115 mm en weighs 470 g (1.04 lbs). The goggles have built-in speakers, a controller, proximity sensor, 3DOF sensors (both headset and controller).
~Any pre-procedural self-administration of pain medication will be recorded. Trained staff-members or senior residents will do all IUD insertions, according to the local protocol."
15807424|NCT04389008|Other|no interventions|no interventions
15807425|NCT04388995|Diagnostic Test|volume expansion|volume expansion with 6% hydroxyethyl starch (7 mL/kg) at a rate of 0.4 mL/kg/min
15807426|NCT04388982|Biological|low dosage MSCs-Exos administrated for nasal drip|Dosage：5μg MSCs-Exos,Total volume： 1ml Frequency：Twice a week Duration：12 weeks
15807427|NCT04388982|Biological|mild dosage MSCs-Exos administrated for nasal drip|Dosage：10μg MSCs-Exos,Total volume： 1ml Frequency：Twice a week Duration：12 weeks
15807428|NCT04388982|Biological|high dosage MSCs-Exos administrated for nasal drip|Dosage：20μg MSCs-Exos,Total volume： 1ml Frequency：Twice a week Duration：12 weeks
15807429|NCT04388943|Other|Observation|Physiological Measurements Patient reported questionnaire Blood sampling
15807430|NCT04388930|Other|Pre-operative assessment - blood, urine, & faecal sample|"Blood sample for multi-parametric flow cytometry. Blood and urine samples for identifying microbial-associated metabolite signature.
~Urine and faecal samples for 16S rRNA gene sequencing"
15807431|NCT04388930|Other|Post-operative day 3 assessment - blood, urine, & faecal sample|"Blood sample for multi-parametric flow cytometry. Blood and urine samples for identifying microbial-associated metabolite signature.
~Urine and faecal samples for 16S rRNA gene sequencing."
15807432|NCT04388930|Other|Post-operative week 4-6 assessment - blood, urine, & faecal sample|"Blood sample for multi-parametric flow cytometry. Blood and urine samples for identifying microbial-associated metabolite signature.
~Urine and faecal samples for 16S rRNA gene sequencing."
15807433|NCT04388930|Other|Post-operative 3 month assessment - blood, urine, & faecal sample|"Blood sample for multi-parametric flow cytometry. Blood and urine samples for identifying microbial-associated metabolite signature.
~Urine and faecal samples for 16S rRNA gene sequencing."
15807434|NCT04388930|Other|Pre-operative 6 month assessment - blood, urine, & faecal sample|"Blood sample for multi-parametric flow cytometry. Blood and urine samples for identifying microbial-associated metabolite signature.
~Urine and faecal samples for 16S rRNA gene sequencing."
15807435|NCT04388930|Other|Post-operative month 12 recipient assessment - blood, urine, & faecal sample|"Blood sample for multi-parametric flow cytometry. Blood and urine samples for identifying microbial-associated metabolite signature.
~Urine and faecal samples for 16S rRNA gene sequencing."
15807438|NCT04388891|Device|Minimally supervised therapy with the ReHapticKnob|The therapy with the ReHapticKnob is performed in the clinic in addition to the conventional therapy. During the supervised and semi-supervised phases (first 2 weeks), the intervention dose is 5 sessions of approximately 45 minutes per week. During each session, the robot proposes a set of 3 exercises, each lasting between 10 and 15 minutes. During the minimally supervised phase (third and fourth week), the duration of the ReHapticKnob therapy is not specified, since the patient can decide by him/herself when to use the device, e.g. during freetime or during the weekend.
15807439|NCT04388878|Drug|PF-07054894|Participants will receive oral ascending doses
15807440|NCT04388878|Drug|Placebo|Participants will receive matching placebo
15807441|NCT04388865|Behavioral|Control|Subjects will engage with their providers as is standard of care.
15807442|NCT04388865|Behavioral|Text-based Clinical Hovering|Subjects will receive remote monitoring via text messaging of clinical symptoms and medication adherence reminders with feedback to social support.
15807443|NCT04388852|Biological|Ipilimumab|Given IV
15807444|NCT04388852|Drug|Valemetostat|Given PO
15807445|NCT04388839|Drug|Vincristine|IV push over 1 minute with dosing ranging from 0.24mg up to 1.5mg
15807446|NCT04388839|Drug|Cyclophosphamide|IV over 60 minutes with dosing ranging from 220mg to 1200mg
15807447|NCT04388839|Drug|Vinorelbine|IV push over 6-10 minutes with dosing ranging from 4mg-25mg
15807448|NCT04388839|Drug|Actinomycin D|Actinomycin D should not be given with radiation. Will be administered through IV over 3-5 minutes with dosing ranging from 0.025mg-0.045mg
15807449|NCT04388839|Drug|Cyclophosphamide Pill|Based on Body Surface Area (BSA) round to nearest 25mg
15807451|NCT04388800|Other|Confront and Navigate Depression Online (CANDO)|This study adopts a blended mode of service delivery, which included both online and offline intervention. The online intervention includes 8 weekly online model, animation briefing and debriefing, case demonstration video, exercise, forum, internal messaging, reminder, online assessment, session review and online booking system. The offline intervention includes two face-to-face sessions and two telephone follow-ups.
15807452|NCT04388774|Drug|Ketamine|A single 40-minute intravenous infusion
15807453|NCT04388761|Drug|Allogeneic adipose derived mesenchymal stem cells|Injection of Allogeneic adipose derived mesenchymal stem cells into the Kidney allograft
15807454|NCT04388748|Behavioral|Stress Management and Resiliency Training for Depression (SMART-D) Therapy|6 SMART-D group therapy sessions over 8 weeks
15807455|NCT04388735|Behavioral|Questionnaire|Series of questions covering quality of life, physical and psychological symptom burden, mood, and illness and prognostic understanding administered in person or remotely.
15807456|NCT04388722|Device|Pulse CO-Oximeter Sensor|Investigational Pulse CO-Oximeter sensor will measure hemoglobin (SpHb) and pleth variability index (PVi).
15807457|NCT04388709|Drug|Peginterferon Lambda-1A|Peginterferon lambda-1a (Lambda) 180mcg subcutaneous injection once
15807458|NCT04388696|Behavioral|Sisterhood 2.0|The Sisterhood 2.0 curriculum was adapted from Program M, created in 2006 by Promundo to address health and empowerment of young women aged 15-24. The curriculum engages young women in questioning rigid and non-equitable stereotypes about masculinity and femininity and how they affect both women's and men's health and well-being.
15807459|NCT04388683|Drug|Nitric Oxide|"Subjects will receive iNO using the INO pulse device at a dose of 125 mcg/kg IBW/hr (equivalent to approximately 20 ppm). The clinical disease severity will be assessed pre-randomization as the worse of 2 scores measured 2 hours apart. Patients eligible for randomization will be those with scores of 1 or 2 (below), and randomization will be stratified according to score (1 or 2). Study drug will begin within 1 hour of randomization. Beginning on the day following randomization (day 1), we will be calculate clinical score, daily, as the average of 3 measurements taken within 2 hour windows centered at 6AM, 2PM, and 10PM."
15807460|NCT04388657|Diagnostic Test|Echo-Doppler|Utrasound Doppler of the lower limbs
15807461|NCT04388631|Other|Coronavirus Disease 2019|male patients who have developed COVID-19
15807462|NCT04388618|Other|NHANES smell and taste tests|participants will be asked to smell 8 cards of different odors and submit your choices in a given card, and so for 3 different taste tips (salty, bitter and neutral). participants will be asked to submit his choices in a given card as well. Then participants photograph those cards and send it via WhatsApp to a given number to be collected
15807463|NCT04388592|Other|Nurse Practitioner (NP) Led Care Arm|The NP will conduct baseline consultation visits with the participants and their caregivers (if applicable). They will then initiate treatment for the participant's symptoms as appropriate (ie: depression treatment for depressive symptoms, fatigue management strategies), connect to resources in the community as needed (ie: rehabilitation programs, home care support, psychologist support) to optimize functioning. There will be scheduled follow visits and/or phone calls with the NP at 3 and 6 months.
15807464|NCT04388579|Other|Pulmonary Rehabilitation|Respiratory Physiotherapy, Exercise Therapy, Patient Education
15807465|NCT04388553|Procedure|single shot lumbar Erector Spinae Plane block|unilateral (operative side), performed at L1 level, under ultrasound guidance
15807466|NCT04388527|Biological|COVID-19 Convalescent Plasma|Participants will receive 2 units of convalescent plasma collected from ABO-compatible donors who have recovered from COVID-19.
15807467|NCT04388514|Procedure|Medical Ozone procedure|The systemic ozone treatment procedure was decided by the physician on duty and started preliminarily at the patient's bed with the drawing of autologous blood and, after proper O2/O3 mixing, with its re-infusion. After junction of an adequate venous patient's way with a dedicated latex free plastic bag containing 35 ml of sodium citrate, a blood amount of 200 ml is taken. At the end, the withdrawal line was washed and the re-infusion one was filled with saline solution. The blood, without any patient disconnection, was then mixed with a gas mixture of a 200 cc composed by 96% of Oxygen and 4% of Ozone with a therapeutic O3 range of 40 μg/mL of gas per mL of blood. In order to guarantee the O2/O3 homogeneous diffusion into the blood, the bag was gently mixed for about 10 minutes, therefore the blood was re-infused into the patients. The duration of ozone treatment lasted for 3 consecutive days.
15807472|NCT04388475|Drug|OKN-007|Drug: OKN-007 (400 mg OKN-007/mL in a phosphate buffer) Administered via IV infusion, at a dose level of 60 mg/kg, given three times a week for 12 weeks, two times a week for a further 12 weeks and once per week until disease progression or up to two years.
15807473|NCT04388475|Drug|Temozolomide (TMZ)|Administered via oral, at a dose level of 150 mg/m2, once daily on Days 1-5 of each 28 day cycle in Cycle 1. If this dose level is tolerated, then in Cycle 2 (and subsequent cycles), at a dose level of 200 mg/m2, once daily on Days 1-5 of each 28 day cycle.
15807474|NCT04388462|Other|Finite element analysis|Biomechanical study to describe micromotion
15807475|NCT04388423|Other|simulated puncture training|The residents are trained of simulated puncture : 1.the location puncture; 2. finding fixed-point needle on the model for 5 times, each time for 30 minutes.
15807476|NCT04388423|Other|traditional bedside teaching|The residents are trained by traditional bedside teaching
15807477|NCT04388410|Biological|convalescent plasma|Plasma obtained from volunteers who have recovered from SARS-Cov-2 infection. Two 200 ml infusions will be administered with 24-72 hours in between.
15807478|NCT04388397|Procedure|Arteriovenous Grafts|Arteriovenous fistulae (AVF) are considered the main access for hemodialysis (HD). Arteriovenous grafts (AVGs) are an alternative access modality in patients with exhausted native venous access. Immediate-access arteriovenous grafts (IAAVGs) is a new modality in which dialysis can be started immediately to avoid complications of central venous catheters.
15807479|NCT04388384|Drug|Neratinib|Neratinib standard dose 240 mg once daily for 1 year
15807480|NCT04388371|Drug|Glutamine|Glutamine will be administered by IV injection prior to PET imaging.
15807481|NCT04388358|Drug|Shin-yi-san + Xiao-qing-long-tang + Xiang-sha-liu-jun-zi-tang by the weight of 9g+3g+3g/day|All patients were treated with mixed formula of Chinese medicine for one month
15807482|NCT04388332|Procedure|Structural allograft|Subjects that have received ACDF structural allograft with plates with autograft and/or allograft comprised of cancellous and/or corticocancellous bone chips
15807483|NCT04388332|Device|Tritanium C|Subjects will receive the Tritanium C anterior cervical cage which is intended to be used with autogenous or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft
15807484|NCT04388319|Drug|Zonisamide|Zonisamide (100 mg/daily) for 12 weeks.
15807485|NCT04388319|Drug|Bupropion|Extended-release bupropion dosing (150 mg each morning days 1-3, then 300 mg/daily) for the remainder of the 12 weeks.
15807486|NCT04388319|Other|Halo G6 e-cigarette|G6 e-cigarette for ad libitum use for two weeks prior to complete switch day.
15807487|NCT04388306|Other|Shoulder Performance Test- Functional Impairment Test-Head and Neck, Shoulder, Arm (FIT-HaNSA)|Participants were evaluated with all tests, respectively. To eliminate the fatigue factor, 5 minutes breaks were given after each test.
15807488|NCT04388293|Other|Exposure of interest|Very Low Birth Weight infants admitted to tertiary NICUs in Canada.
15807489|NCT04388280|Diagnostic Test|Echocardiography|Functional assessment of coronary artery disease
15807490|NCT04388280|Diagnostic Test|CT angiography|Anatomical assessment of coronary artery disease
15807491|NCT04388267|Drug|Fluid challenge|"All patients who met the inclusion criteria will receive a standardised bolus of 250 ml of crystalloid in 5 minutes administered by hand with a 50 ml syringe.
~During the study period, hemodynamic parameters and analysis by pressure recording analytical method obtained with the MostCare will be collected for 20 minutes prior to the intervention (fluid challenge), during the fluid challenge and 25 minutes after completion.
~The total duration of the intervention (fluid loading) is 5 min. The total duration of hemodynamic parameters recording is 60 min."
15807492|NCT04388254|Drug|Simufilam 100 mg oral tablet|Simufilam 100 mg oral tablet for b.i.d. administration
15807493|NCT04388254|Drug|Placebo|Matching placebo oral tablets
15807494|NCT04388241|Behavioral|The Balance Program|The Balance Program is a four-week behavioral intervention (each session lasting 60 minutes) developed specifically for the pediatric SCD population based on existing evidence-based treatments to target the unique presentation of pain-related disability in SCD.
15807495|NCT04388228|Other|Extended audit and feedback in GPs electronic health record|"The intervention consists of an extended electronically delivered feedback with multiple components which will be delivered 4 times electronically into general practices over 12 months.
~This extended feedback report consists of:
~Benchmarking of the results of the audit versus peers, versus guidelines and versus disease specific laboratory results.
~A low cognitive load of the feedback where the results will be presented with the help of graphs.
~Action plans to improve the quality of registration
~A push system to minimize the effort the GP must make to consult the feedback."
15807496|NCT04388215|Drug|CKD-828|orally, 1 tablet once a day for 8 weeks
15807497|NCT04388215|Drug|CKD-828(placebo)|orally, 1 tablet once a day for 8 weeks
15807498|NCT04388215|Drug|D326|orally, 1 tablet once a day for 8 weeks
15807499|NCT04388215|Drug|D326(placebo)|orally, 1 tablet once a day for 8 weeks
15807500|NCT04388215|Drug|D337|orally, 1 tablet once a day for 8 weeks
15807501|NCT04388215|Drug|D337(placebo)|orally, 1 tablet once a day for 8 weeks
15807502|NCT04388215|Drug|D013|orally, 1 tablet once a day for 8 weeks
15807503|NCT04388215|Drug|D013(placebo)|orally, 1 tablet once a day for 8 weeks
15807504|NCT04388202|Drug|Sertraline|FDA approved antidepressant
15807505|NCT04388202|Drug|Escitalopram|FDA approved antidepressant
15807506|NCT04388189|Drug|Duloxetine|FDA approved antidepressant
15807507|NCT04388189|Drug|Bupropion|FDA approved antidepressant
15807508|NCT04388176|Drug|C21|C21 as first treatment
15807509|NCT04388176|Drug|C21|C21 as second treatment
15807510|NCT04388176|Drug|Placebo|Placebo as second treatment
15807511|NCT04388176|Drug|Placebo|Placebo as first treatment
15807512|NCT04388163|Drug|Gentian Violet|Gentian violet is a topical antiseptic used to treat many cutaneous yeast infections. It also has a role in improving wound healing in sites of active ulceration.
15807513|NCT04388150|Diagnostic Test|Upper gastrointestinal endoscopy and biopsy|Gastroscope with technology of VIST video intelligent staining technology for taking biopsies
15807514|NCT04388137|Other|No intervention.|No intervention.
15807515|NCT04388124|Drug|Bosentan|vascular assesment Clinical exam urinary analysis blood results natriuresis and measured glomerular filtration rate
15807516|NCT04388124|Drug|Placebo|Placebo
15807518|NCT04388098|Other|Diagnosis of caries experience and periodontal health|
15807519|NCT04388059|Procedure|Laparoscopic sleeve gastrectomy|Laparoscopic sleeve gastrectomy at 2 and 5 cm from the pylorus on the postoperative weight loss, GLP1 levels and the glycemic control in morbid obese diabetic adolescents.
15807520|NCT04388046|Device|Herbst fixed functional appliance|Herbst appliance could be considered as an artificial joint working between maxilla and mandible. The appliance consists of a bilateral telescope mechanism attached to upper and lower jaws keeping the mandible in an anterior jumped position.
15807521|NCT04388033|Biological|Dendritic Cell/Tumor Fusion Vaccine|Vaccine is derived from the participants dendritic cells and tumor cells.
15807522|NCT04388033|Drug|Interleukin-12|Given subcutaneously at dose of 6ug twice for interval of one hour.
15807523|NCT04388033|Drug|Temozolomide|Following concomitant radiation (2 Gy/day x 30 days) and TMZ-chemotherapy (75 mg/m2/ day x 42 days) , maintenance chemotherapy with TMZ will be administered at 150-200 mg/m2/day for 5 days in each 28-day cycle.
15807524|NCT04388020|Device|Tabletop prototype of eSpecs: Active projection of defocused image in the peripheral visual field|For the right/test eye, a defocused image is projected onto the peripheral retina while the subject views a distant, in-focus image
15807525|NCT04388020|Device|Tabletop prototype of eSpecs: No Active projection of defocused image in the peripheral visual field|For the left/control eye, no image is projected onto the peripheral retina. The subject views a distant, in-focus image.
15807526|NCT04388007|Other|Thoracic spinal manipulation|High velocity, low amplitude force manipulation
15807527|NCT04387994|Other|Blood samples collection|Collection of blood samples from consenting subjects to evaluate circulating biomarkers concentrations.
15807528|NCT04387981|Drug|[14C]-orvepitant|Oral solution of [14C]-orvepitant
15807529|NCT04387968|Diagnostic Test|Covid-19 presto test|Use an auto-test in 15 minutes get the results about covid-19 anticorps
15807530|NCT04387955|Diagnostic Test|Biological Sample Collection|"Diagnostic test : biological sample collection at Day 0
~Two skin biopsies on chilblain at Day 0 (one biopsy for histological analysis, one biopsy for basic research)
~Anal swabbing at Day 0
~Blood test at Day 0
~Blood test at Month 1
~Blood test at Month 2"
15807531|NCT04387942|Drug|IL-2|For all patients,rhIL-2 infusions seven days;recurrent patients was applied again for 7 days;patients who were diagnosed HSPN were treated on a routine basis for 7 consecutive days, and then once every two week for 3months.
15807532|NCT04387929|Diagnostic Test|Detection of anti-COVID-19 antibody level|Detection of anti-COVID-19 antibody level form blood samples. If positive, viral load will be measured by RT-PCR of nasopharyngeal swab.
15807533|NCT04387916|Drug|KC1036|Part 1: Dose-escalation phase , KC1036 10mg~120mg, consists of 5 Cohorts. Part 2: Dose-expansion phase, consists of 3~4 Cohorts based on part 1. Part 3:RP2D-extension phase, Recommended dose of KC1036 based on part 1and part 2.
15807534|NCT04387903|Procedure|Surgical re-interventionafter pancreaticoduodenectomy|Mandatory surgical management of complications after pancreatico-duodenectomy through peritoneal lavage, draiange, repair of fistula, completion pancreatectomy, control of bleeding, bowel resection, and feeding jejunostomy.
15807535|NCT04387890|Diagnostic Test|Serologic SARS-CoV-2 screening|Quantitative Indirect Chemiluminescence Immunoassay (CLIA) to access SARS-CoV-2 specific IgM and IgG serum antibody level every 2 weeks during follow up
15807536|NCT04387877|Device|Graston|"Graston technique will be applied on the lateral and posterior fascia (tensor fascia lata, gluteus medius, gluteus minimus, gluteus maximus, hamstring, gastrocnemius and soleus muscles) in 15 minutes.
~For the first 2 weeks; dorsolumbar stabilization, straight and side leg lifting, gluteal setting, side walking exercises For the second 2 weeks; dorsolumbar stabilization counting on spot, straight and side leg lifting, gluteal setting, side walking exercises with 0.5 kg weight on the ankle, piriformis, tensor fascia lata and hamstring stretching exercises"
15807537|NCT04387877|Other|Sham|"Sham graston technique will be applied on lateral and posterior fascia (tensor fascia lata, gluteus medius, gluteus minimus, gluteus maximus, hamstring, gastrocnemius and soleus muscles) in 15 minutes.
~(Sham graston technique will be applied by partially touching the skin overlying the muscle or fascia region via ultrasound gel with the flat part of the Graston instrument so as not to provide any activity of the fascia) For the first 2 weeks; dorsolumbar stabilization, counting on spot, straight and side leg lifting, gluteal setting, side walking exercises For the second 2 weeks; dorsolumbar stabilization counting on spot, straight and side leg lifting, gluteal setting, side walking exercises with 0.5 kg weight on the ankle, piriformis, tensor fascia lata and hamstring stretching exercises"
15807538|NCT04387864|Device|Whole-body Vibration Device|Power Plate® (pro5TM; Power Plate North America, Inc., Northbrook, IL, USA)
15807539|NCT04387851|Behavioral|Placebo induction|The placebo interventions of interest are experimental learning methods (e.g. verbal suggestion, conditioning), used to induce placebo effects on somatosensory sensations.
15807540|NCT04387851|Behavioral|Control|Placebo and nocebo effects should be measured relative to a control group (between-subjects design). In the case of within-subjects designs, these will be included to the extent possible (in a separate analysis or descriptively depending on the number of results).
15807541|NCT04387851|Behavioral|Nocebo|The nocebo interventions of interest are experimental learning methods (e.g. verbal suggestion, conditioning), used to induce nocebo effects on somatosensory sensations.
15807542|NCT04387838|Diagnostic Test|Anti-SARS-CoV2 Serology|A blood sample is collected by venipuncture at Day 0, Day 30 and Day 60. The anti-SARS-CoV2 serological status is measured by automated microplate ELISA technique on the EVOLIS analyzer (Biorad®), using reagent kits from EUROIMMUN France.
15807543|NCT04387838|Other|Questionnaire|"Data concerning personal exposure factors are collected in a questionnaire:
~Socio-demographic factors: sex, age
~Professional factors: Employment (type, pace, reception, service, care practices), wearing of personal protective equipment (type of equipment, frequency of use) and type of hospital
~Non-professional factors: Contact with infected individuals, carrying of professional equipment and compliance with barrier measures"
15807544|NCT04387825|Drug|ADSVF application in the right hand|40 ml of fat was mixed with 2 ml of ADSVF and placed in 1-ml and 3-ml syringes. Using a 19-gauge blunt cannula (0.8 mm), 0.5 ml was applied to the radial and ulnar edge of each metacarpal phalangeal (MP) and interphalangeal (IP) joint in contact with each neurovascular digital pedicle and 3 ml was applied to each side of the metacarpal trapezius joint, together with 10 ml distributed subcutaneously throughout the palm of the hand and 10 ml evenly distributed on the back of the hand
15807545|NCT04387812|Device|Xtrodes home PSG system|Wireless, convenient and relies on actual recording of EMG, EOG and EEG in a home setting
15807546|NCT04387799|Diagnostic Test|Serology for Covid-19|Antibody tests designed to provide results to individuals or healthcare providers can show whether someone was previously infected with SARS-CoV-2 being the RT-PCR negative for the population of patients
15807547|NCT04387786|Drug|Dornase Alfa|nebulized in-line endotracheal dornase alfa co-administered with albuterol
15807548|NCT04387773|Drug|GOCOVRI|"Participants will have gait and balance baseline assessment and then repeat assessment after being on full-dose of GOCOVRI for two weeks. The assessments will include measures of gait, balance and dyskinesia. Participants will also wear body-worn sensors (on wrist, feet and lumbar area) during daily-life for seven days to quantify mobility.
~GOCOVRI will be started at 137mg/day for two weeks and then increased to 274mg/day for two weeks. Participants will repeat baseline assessments and then decrease to a dose of 137mg/day of GOCOVRI for one week, before stopping the medication completely.
~All participants will receive GOCOVRI and they will know that they are on study drug. No placebo group."
15807552|NCT04387747|Other|SARCOPENIA IN STROKE PATIENTS|Demographic characteristics, duration of stroke, sarcopenia presence,thigh circumference , Hand grip strength , TANITA BIA analysis
15807553|NCT04387734|Drug|Ocrelizumab|Ocrevus will be administered following the FDA's regulations.
15807554|NCT04387734|Drug|Platform|The applications of the platform DMTs will follow the FDA-approved regulations.
15807555|NCT04387721|Other|Kind of trifocal IOL|Patients will be divided between groups based on pre-surgery corneal astigmatism. Group FineVision is made up of patients with corneal astigmatism less than 1 D. Groups FineVision Toric is made up pf patients with corneal astigmatism more than 1.25 D
15807556|NCT04387695|Radiation|SBRT+TACE+Sorafenib|SBRT first for the PVTT +TACE for HCC within a week next +Sorafenib with 2 weeks later
15807557|NCT04387695|Drug|Sorafenib|Sorafenib 800 mg/day orally
15807558|NCT04387682|Dietary Supplement|β-glucan|β-glucan, a biological response regulator, derived from yeast has been known for more than 45 years, and has anti-infective and anti-tumor activities. β-glucan is a molecule with a β-1,3-linked D-glucose backbone and β-1,6-linked side chains. Thus far, at least 4 receptors for β-glucan have been discovered in humans, which are surface antigens associated with macrophages or myeloid precursor cells as complement receptor 3 (CR3; CD11b/CD18, Mac-1, αMβ2 integrin) (Vetvicka et al. 1996; Xia et al. 1999), lactosylceramide (Zimmerman et al. 1998), scavenger receptor (Rice et al. 2002) and dectin-1 (Brown et al. 2003; Taylor et al. 2007; Saijo et al. 2007).
15807563|NCT04387643|Dietary Supplement|Ayurvedic Kadha|Kadha (also called Kwath and Kashaya) is a type of ayurvedic formulation prepared by boiling herbs in water. Water and herbs are main ingredients of these preparations. The preparation of Kadha uses dry herbs, which are dried under the sun or in the shade, as directed for the individual herb. Then, the herbs are pounded to form a coarse powder
15807564|NCT04387630|Drug|Metformin|Oral hypoglycemic drug. Initial dose 500-850 mg/d. incrementally increased to a maximum daily dose of 2550 mg in three divided doses.
15807565|NCT04387630|Drug|Placebo oral tablet|Simethicone 60 mg three times daily.
15807566|NCT04387617|Drug|Cannabidiol|The product is a liquid formulation that will be prescribed at a dosage of 20 mg per day for a total of 3 days.
15807567|NCT04387617|Drug|Placebo|The product is a liquid formulation placebo that will be prescribed at an equivalent volume as active drug for 3 days
15807568|NCT04387604|Drug|Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]|"PRN regimen. Treatment Schedule Repeat injections at every 4-week visit if eye improves or worsens (defined as ≥5 letter change from last injection or ≥10% CST change on OCT from last injection or CSF>300 μm at any timepoint).
~Defer injections if either BCVA of 85 letters and OCT CSF normal (CSF≤300 μm and non-existent intra- or sub-retinal fluid); or OCT CSF normal (CSF≤300 μm) and stable BCVA (defined as < 5 letters change from last injection) after two consecutive injections during the first 24 weeks, or after one injection if the initial stability period has already been achieved (OCT CSF normal and stable BCVA).
~Resume injections if BCVA or OCT worsens."
15807569|NCT04387591|Procedure|Fu's subcutaneous needling(FSN)|In this study, the doctor will use a disposable Fu's subcutaneous needling(FSN) to penetrate the subject's skin of the middle of medial epicondyle and radial styloid process. Then the doctor will push forward the needle parallel to the skin surface (maintaining in the subcutaneous layer), towards the subject's medial epicondyle. The docotr will sway the needle 50 times in 30 seconds. After swaying the needle, the doctor will instruct the subject to do elbow flextion for 10 seconds resisting the doctor's opposite force, then the subject take a rest for 10 seconds. The above actions(elbow flexion and rest) are 3 repetitions. Then the subject do palmar flexion in the position of elbow flexion for 10 seconds resisting the doctor's opposite force, and take a rest for 10 seconds. These actions are also 3 repetitions. After the above reperfusion approach of muscles, the doctor will take out the needle to finish the treatment.
15807633|NCT04387032|Other|Sham Manipulation|The sham procedure was the same, but no external force was introduced in the form of a therapeutic impulse.
15807634|NCT04387019|Diagnostic Test|blood sampling|blood sampling from peripheral vein
15807635|NCT04387006|Other|OMT|OMT techniques were focused on correcting the dysfunctions found during the initial physical examination and included articular and myofascial techniques, balanced ligamentous tension, visceral manipulations and osteopathy in the cranial field
15807570|NCT04387591|Procedure|Transcutaneous Electric Nerve Stimulation|Transcutaneous electrical nerve stimulation (TENSor TNS) is the use of electric current produced bya device to stimulate the nerves for therapeuticpurposes. TENS, by definition, covers the completerange of transcutaneously applied currents usedfor nerve excitation although the term is often usedwith a more restrictive intent, namely to describe thekind of pulses produced by portable stimulators usedto treat pain. The unit is usually connected to theskin using two or more electrodes. A typical batteryoperated TENS unit is able to modulate pulse width,frequency and intensity. Generally TENS is applied athigh frequency (>50 Hz) with an intensity below motorcontraction (sensory intensity) or low frequency (<10Hz) with an intensity that produces motor contraction
15807571|NCT04387578|Device|fixed orthodontic appliance and arch wires|leveling and aligning stages in orthodontics
15807572|NCT04387565|Other|magnesium and vanadium measurements and compare|Magnesium and vanadium will be measured using inductively coupled plasma-mass spectrometry (Thermo Scientific ICAPQc, USA).
15807573|NCT04387552|Behavioral|Prenatal Safe Sleep Mobile Health (mHealth) Messaging|Participants will receive prenatal Safe Sleep mHealth messaging starting at 34 weeks gestation until birth of their baby.
15807574|NCT04387552|Behavioral|Prenatal Breastfeeding Mobile Health (mHealth) Messaging|Participants will receive prenatal Breastfeeding mHealth messaging starting at 34 weeks gestation until birth of their baby.
15807575|NCT04387552|Behavioral|Postnatal Safe Sleep Mobile Health (mHealth) Messaging|Upon birth of baby, participants will begin receiving postnatal Safe Sleep mHealth messaging for a two month period.
15807576|NCT04387552|Behavioral|Postnatal Breastfeeding Mobile Health (mHealth) Messaging|Upon birth of baby, participants will begin receiving postnatal Breastfeeding mHealth messaging for a two month period.
15807577|NCT04387539|Drug|SOF/SMV/DCV/RBV|SOF was given orally at a dose of 400 mg/day DCV was given orally at a dose of 60 mg/day SMV was given orally at a dose of 150 mg/day. RBV was given in a total daily oral dose of 600 mg/day up to 1,200 mg/day according to the participant's weight and tolerability.
15807578|NCT04387526|Drug|(SOF and DCV)|
15807579|NCT04387526|Drug|(SOF, DCV, and RBV)|
15807580|NCT04387513|Procedure|Cardiac surgery|Cardiac surgery, if indicated, delayed or not by neurological complications
15807581|NCT04387500|Drug|Sintilimab injection plus Inlyta treatment|Combined Sintilimab injection and Inlyta treatment in FH-deficient RCC
15807582|NCT04387487|Behavioral|Multimedia video information|"During pre anesthesia visit after regular pre anesthesia check up patient will be asked to fill the Hamilton scoring questionnaire about anxiety.
~After this a multimedia video information about spinal anesthesia of around 6 minutes will be shown to the intervention group during pre anesthesia visit. This video will contain explanation about how spinal anesthesia procedure is conducted. Patient will be allowed to ask questions.
~On the day of surgery in the pre surgical area again Hamilton scoring questionnaire will be asked with the patients to check the level of anxiety."
15807583|NCT04387474|Device|Brain-computer interface|brain-computer interface rehabilitation training.
15807584|NCT04387474|Other|Traditional rehabilitation|traditional rehabilitation training.
15807585|NCT04387461|Biological|CG0070|Engineered Oncolytic Adenovirus
15807586|NCT04387461|Biological|Pembrolizumab Injection|Immune checkpoint inhibitor, Monoclonal antibody
15807587|NCT04387461|Other|n-dodecyl-B-D-maltoside|Transduction-enhancing agent.
15807588|NCT04387448|Drug|GFB-887|Investigational Medicinal Product (IMP)
15807589|NCT04387448|Drug|Placebo|Matching
15807590|NCT04387435|Other|A change or titration in the current or frequency settings of the VNS therapy system.|The study treatment involves changing the output current or frequency of the default device settings in a FDA approved device for VNS therapy. The proposed frequency changes in this study are within the FDA approved output current and frequency levels.
15807591|NCT04387422|Other|Experimental hyperglycemia|Experimental hyperglycemia with MRI
15807592|NCT04387409|Biological|VPM1002|The investigational product will be administered via intradermal injection with a 1.0-ml syringe, sub-graduated into hundredths of ml (1/100 ml), and fitted with a short bevel needle (25G/0.50 mm or 26G/0.45 mm, 10 mm in length).
15807593|NCT04387409|Biological|Placebo|The investigational product will be administered via intradermal injection with a 1.0-ml syringe, sub-graduated into hundredths of ml (1/100 ml), and fitted with a short bevel needle (25G/0.50 mm or 26G/0.45 mm, 10 mm in length).
15807594|NCT04387396|Other|Exercise|Exercise specific to knee osteoarthritis.
15807595|NCT04387383|Device|Acupuncture|Disposable acupuncture needles (0.30 mm in diameter and 25-40 mm in length) are inserted at a depth of 10-30 mm obliquely into scalp acupuncture points (Baihui, Toulinqi) or straightly into body acupuncture points (Taichong, Zhangmen, Sanyinjiao, Zhongwan, Guanyuan, Tianshu, Zusanli). Electroacupuncture will be applied to the abdominal points at fast and dispersed waves through electric needle stimulator (ES-160 6-Channel Programmable Electro-acupuncture) for 30 min. The intensity is adjusted to a level at which patients feel comfortable.
15807596|NCT04387383|Device|Sham-acupuncture|Disposable acupuncture needles (0.30 mm in diameter and 25-40 mm in length) are inserted at the same way as in the acupuncture group but on sham-acupuncture points (Sham-Baihui, Sham-Toulinqi, Sham-Taichong, Sham-Zhangmen, Sham-Sanyinjiao, Sham-Zhongwan, Sham-Guanyuan, Sham-Tianshu, Sham-Zusanli). The sham points are non-acupuncture points nor located on meridians
15807597|NCT04387318|Device|Multimodal training|"IMT will be performed using the POWERbreathe® Medic Plus inspiratory training device for five sets of 10 repetitions each, with a one-minute interval between each set. The initial load set will be 30% of maximal inspiratory pressure (MIP), during the first two weeks to allow for an adjustment period. The IMT wil be performed two times per week for 8 weeks.
~NMES will be applied using an calibrated electrical stimulator (Neurodyn High Volt, IBRAMED, São Paulo/São Paulo, Brazil). The following parameters will be used: 50 Hz frequency, pulse duration of 400 µs, work cycle of 5 seconds ON and 15 seconds OFF (first month) adjusted for 10 seconds ON and 30 seconds OFF (second month) and maximum intensity tolerated during 2 times per week for 8 weeks.
~Pulmonary Rehabilitation The pulmonary rehabilitation will consist of aerobic and resistance exercise during 8 weeks."
15807662|NCT04386733|Other|no intervention, it was an observational study which looked at the reasons for surgical cancellations|the investigators observed how many patients had their surgeries cancelled and analysed the reasons of these cancellations
15807663|NCT04386707|Biological|Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age|Three doses of experimental sIPV of lot 1 at the schedule of 2,3,4 months of age
15807598|NCT04387318|Device|IMT + Pulmonary Rehabilitation|"IMT will be performed using the POWERbreathe® Medic Plus (POWERbreathe Medic Plus ®, SP, BR) inspiratory training device for five sets of 10 repetitions each, with a one-minute interval between each set. The initial load set will be 30% of maximal inspiratory pressure (MIP), during the first two weeks to allow for an adjustment period. After that, load increases occurred as follows: 35% of MIP in week 3, 40% of MIP in week 4, 45% of MIP in week 5, 50% of MIP at week 6, 55% of MIP in week 7, and 60% of MIP in weeks 8.
~Pulmonary Rehabilitation The pulmonary rehabilitation will consist of aerobic and resistance exercise during 8 weeks."
15807599|NCT04387318|Device|NMES + Pulmonary Rehabilitation|"NMES will be applied using an calibrated electrical stimulator (Neurodyn High Volt, IBRAMED, São Paulo/São Paulo, Brazil). The following parameters will be used: 50 Hz frequency, pulse duration of 400 µs, work cycle of 5 seconds ON and 15 seconds OFF (first month) adjusted for 10 seconds ON and 30 seconds OFF (second month) and maximum intensity tolerated during 2 times per week for 8 weeks.
~Pulmonary Rehabilitation The pulmonary rehabilitation will consist of aerobic and resistance exercise during 8 weeks."
15807600|NCT04387318|Device|Pulmonary Rehabilitation|Pulmonary Rehabilitation The pulmonary rehabilitation will consist of aerobic and resistance exercise during 8 weeks.
15807601|NCT04387305|Drug|Tranexamic acid injection|Active drug is provided to participants as described based on the TXA arm they are randomized to.
15807602|NCT04387292|Procedure|Ophthalmologic exam|"Visual acuity (ETDRS exam)
~Slit lamp examination : fluorescein test, Oxford score, break up time, Schirmer II test
~Lipiview
~Eye pressure measurement (air tonometer)
~Wide field retinophotography
~Multicolor and auto-fluorescence retinophotography
~Indocyanine green retinal angiography
~Optical coherence tomography (OCT) B posterior pole scan
~OCT Angiography (OCT-A) of the optic nerve and posterior pole
~Adaptive optics
~Visual field (Humphrey)"
15807603|NCT04387279|Other|Interview|Surveys on medical use patterns and patient's perceptions about COVID-19
15807604|NCT04387266|Radiation|modified reduce-volume target IMRT|The gross tumor volume of the nasopharynx and neck nodes (GTVnx and GTVnd) were delineated according to the tumor extension. The CTVnx was defined as GTVnx + nasopharynx mucosa + 8mm +corresponding anatomical structure without the delineation of CTV1. The CTVnd was defined as GTVnd plus the elective neck area. The prescribe doses of GTVnx/GTVnd, CTVnx, CTVnd were 66-70Gy,54-56Gy and 50-54Gy in 31-35 fractions, respectively.
15807605|NCT04387253|Diagnostic Test|Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus|Identification by PCR of the SARS-COV-2 virus in samples taken from the fetus Presence of SARS-COV-2 virus in samples taken from mother and father. Circulating anti-SARS-COV-2 antibodies in the mother.
15807606|NCT04387240|Drug|Artemisinin / Artesunate|testing the drug capabilities in reducing the shedding and causing the testing for covid 19 to become negative
15807607|NCT04387240|Other|placebo|placebo or sham drug will be given to the second arm
15807608|NCT04387227|Drug|Carboplatin|Given IV
15807609|NCT04387227|Biological|Pembrolizumab|Given IV
15807610|NCT04387214|Other|survey|online survey
15807611|NCT04387201|Drug|Dulaglutide|Dulaglutide 0.75 mg subcutaneous weekly for 2 weeks, followed by 1.5 mg subcutaneous weekly for 4 weeks
15807612|NCT04387201|Drug|Cyanocobalamin|Cyanocobalamin (vitamin B12) 1000 mcg subcutaneous weekly for 6 weeks
15807613|NCT04387175|Device|Carriere Motion 3D Class III Appliance|The device made of stainless steel consists of a flexible bar with two pads at the end which are bonded bilaterally with composite resin to the lower second deciduous molar or the lower first permanent molar at the rear and the lower deciduous canine at the front. The base on the lower deciduous canine has a hook to which bilaterally elastic latex bands are connected with the vestibular tubes of the cemented bands on the upper deciduous second molars (Force 2 elastics ) or on the first permanent upper molars (Force 1 elastics), on whose palatine surface the a rapid maxillary expander is welded.
15807614|NCT04387175|Device|Facial mask|The facial mask consists of a chin pad and frontal pad connected by a central steel bar. On the central bar there is a horizontal steel bar to which latex elastic bands are attached which develop 14 ounces of force. The elastics are connected to the rapid maxillary expander by means of two hooks welded on the bands of the second upper deciduous molars or the first upper permanent molars.
15807615|NCT04387162|Behavioral|Prism Adaptation Treatment|Spatial retraining treatment
15807616|NCT04387136|Drug|Sublingual Sufentanil|15-30 minutes prior to planned emergence from anesthesia patients will either receive 30 mcg of sublingual sufentanil dispensed by the anesthesia provider.
15807617|NCT04387123|Procedure|Vaginoscopy|Vaginoscopic examination and possible operative endoscopic management
15807618|NCT04387110|Drug|Ocrelizumab|Receiving either 1infusion (600mg) or 2 infusions (300mg).
15807619|NCT04387097|Drug|remifentanil|postoperative drip-infusion of remifentanil
15807620|NCT04387084|Drug|Atezolizumab|Given IV
15807621|NCT04387084|Drug|Avelumab|Given IV
15807622|NCT04387084|Biological|Cemiplimab|Given IV
15807623|NCT04387084|Biological|Durvalumab|Given IV
15807624|NCT04387084|Biological|Nivolumab|Given IV
15807625|NCT04387084|Biological|Pembrolizumab|Given IV
15807626|NCT04387084|Other|Quality-of-Life Assessment|Ancillary studies
15807627|NCT04387084|Other|Short-Term Fasting|Undergo STF
15807630|NCT04387058|Device|TIPS|TIPS (Transjugular Intrahepatic Portosystemic Shunt) is an interventional radiology method that creates an anastomosis between the portal venous network and the hepatic venous network.
15807631|NCT04387045|Behavioral|Guilty feelings|Participants write for 20 minutes about situations that have caused them feelings of guilt throughout their lives.
15807632|NCT04387032|Other|HVLA Manipulations|The procedure of experimental manipulation: the patient lay on the healthy side with the straight lower limb, and the torso turned towards the dysfunctional side, whose lower limb was bent in the hip and knee joint, and the hands rest on the lower ribs on the same side. The therapist allowed the initial loosening of the tissues and chose the movement barrier with his stabilizing hand. Then, with the treatment hand, he introduced the HVLA thrust through the iliac bone towards the bottom, while giving the iliac bone a posterior or anterior rotation - meaning, the opposite to the occurring dysfunction. If during the manipulation, no cavitation sound was heard, the HVLA thrust was repeated once.
15807636|NCT04387006|Other|MP|MP treatment was performed by the same osteopaths who performed OMT and was carried out in the same hospital setting. P treatment consisted of a passive touch without joint mobilization in a protocolled order. The osteopaths were standing next to the bed, they touched lumbar and dorsal spine of the subjects in prone position for 10 minutes, and then in supine position, they touched for 10 minutes the shoulders, the hips, then the neck, the sternum and the chest were touched for 5 minutes each. Another researcher on the placebo protocol specifically trained the osteopaths.
15807637|NCT04386993|Radiation|Intensity modulated radiation therapy|Radiation should be delivered over the course of 1-2 weeks (allowing for weekends/holidays).
15807638|NCT04386980|Drug|Resiniferatoxin|Resiniferatoxin is a compound purified from natural sources.
15807639|NCT04386980|Drug|Placebo|Diluent in normal saline
15807640|NCT04386967|Biological|OH2 injection|Oncolytic Type 2 Herpes Simplex Virus
15807641|NCT04386967|Drug|Keytruda|Anti-PD-1 antibody
15807642|NCT04386954|Procedure|observational study|observation study
15807643|NCT04386941|Procedure|Xpeeda Fibre Laser Vaporesection of the Prostate|"Both interventions are currently used standard of care treatments for the Holmium laser enucleation of the prostate (HoLEP) for patients with bothersome lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH).
~Holmium Xpeeda side firing fibre was introduced and it stands apart from other available technologies as a combination of power and efficiency, which minimizes vaporization time. This technology seems to revolutionize utilization of the Holmium power and delivering more energy directly to the tissue, due to its capability of being in contact with the tissue."
15807644|NCT04386941|Procedure|Greenlight XPS Vaporization of the Prostate|The introduction of the Xcelerated Performance System (XPS) 180W in 2010 with the MoXy fibers represents the highest-powered system currently in use for this type of laser.11 It encourages the adoption of the enucleation principle, making it a real contender to HoLEP in treating large adenomas. Despite the fact that large prostates often require more energy and longer operative time, the XPS system has reduced the operative time and number of fibers required in these situations.
15807645|NCT04386915|Drug|GST-HG141 tablets|This trial includes single-dose studies and multiple-dose studies, The single-dose study included six dose groups of 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, and 500 mg. Based on the results of a single dose, select 1 to 3 doses from 100mg, 200mg, 300mg, and 400mg to conduct multiple dose studies.
15807646|NCT04386915|Drug|Placebo|This trial includes single-dose studies and multiple-dose studies, The single-dose study included six dose groups of 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, and 500 mg. Based on the results of a single dose, select 1 to 3 doses from 100mg, 200mg, 300mg, and 400mg to conduct multiple dose studies.
15807647|NCT04386902|Device|Neurosteer Aurora system|The system is composed of hardware and software modules that facilitate the capture and interpretation of electrophysiological data as well as enable viewing the processed data in real time and offline. An electrode patch is attached on the subject's forehead to capture the electrophysiological signal. The signal is sent via low energy Bluetooth to an EEG Monitor. The signal is then sent via Wi-Fi to the cloud where the data is stored on a HIPAA compliant server. Data analysis performed in the cloud transforms the electrophysiological signal into easily readable data of brain activity, which is accessible via any web interface.
15807648|NCT04386889|Other|Vasculitis In SLE|20 SLE female Egyptian patients, among them we are going to study the vasculitic pattern incidence.
15807649|NCT04386876|Drug|Lopinavir/Ritonavir 200 mg/50 mg Film Tablet|Lopinavir/Ritonavir film tablet containing 200 mg lopinavir and 50 mg ritonavir (World Medicine-Turkey).
15807650|NCT04386876|Drug|Lopinavir/Ritonavir 200 mg/50 mg Film Coated Tablet|Lopinavir/Ritonavir film coated tablet containing 200 mg lopinavir and 50 mg ritonavir(AbbVie Deutschland GmbH & Co.-Germany)
15807651|NCT04386850|Drug|Oral 25-Hydroxyvitamin D3|Subjects in the case group will receive 25 mcg of 25(OH)D3 once daily at bedtime for 2 months and the control group will receive placebo daily for 2 months.
15807652|NCT04386837|Other|Turkish Aphasia Rapid Test|Same
15807653|NCT04386824|Other|Erectil dysfunction|A complete ophthalmological examination including best-corrected visual acuity using the decimal system (BCVA), measurement of intraocular pressure (IOP) and axial length (AL), slit-lamp examination and dilated fundus examination
15807654|NCT04386811|Drug|Calcitriol|A total of 24 otherwise medically healthy individuals with ADHD will be studied as outpatients. All subjects will undergo neurocognitive assessments of attention/vigilance, spatial working memory, and reversal learning both before and after subjects' daily dosing with their currently prescribed stimulant medication on both calcitriol and placebo pretreatment days using a randomized, double-blind, placebo controlled, within-subject, two-day study design.
15807655|NCT04386811|Other|Placebo|A total of 24 otherwise medically healthy individuals with ADHD will be studied as outpatients. All subjects will undergo neurocognitive assessments of attention/vigilance, spatial working memory, and reversal learning both before and after subjects' daily dosing with their currently prescribed stimulant medication on both calcitriol and placebo pretreatment days using a randomized, double-blind, placebo controlled, within-subject, two-day study design.
15807656|NCT04386798|Other|survey work|Bebeği Yenidoğan Yoğun Bakım Ünitesinde Yatan Annelerin Stres ve Anksiyete Düzeyleri anket yöntemi ile ölçülecektir.
15807657|NCT04386772|Procedure|PVE with coils plus TAGM|PVE with TAGM distally and coils proximally and subsequent scheduled major hepatectomy. Sequential transcatheter arterial chemoembolization and PVE for patients with HCC. Selective biliary drainage on future liver remnant (FLR) side for patients with pCCA when obstructive jaundice is present.
15807658|NCT04386772|Procedure|PVE with multiple coils|Procedure: PVE with multiple coils PVE with multiple coils proximally and distally and subsequent scheduled major hepatectomy. Sequential transcatheter arterial chemoembolization and PVE for patients with HCC. Selective biliary drainage on FLR side for patients with pCCA when obstructive jaundice is present.
15807659|NCT04386759|Other|Cohort|None. Only implementation of a cohort with data collection via individual self-questionnaires and administrative services for contextual data.
15807660|NCT04386746|Drug|Gemcitabine|1g gemcitabine in 50ml sterile water; instilled once weekly for 6 weeks and then once monthly for ≤ 21 months.
15807661|NCT04386746|Drug|Docetaxel|37.5mg docetaxel in 50ml normal saline solution (NSS); instilled once weekly for 6 weeks and then once monthly for ≤ 21 months.
15807664|NCT04386707|Biological|Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age|Three doses of experimental sIPV of lot 2 at the schedule of 2,3,4 months of age
15807665|NCT04386707|Biological|Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age|Three doses of experimental sIPV of lot 3 at the schedule of 2,3,4 months of age
15807666|NCT04386707|Biological|Three doses control wIPV at the schedule of 2,3,4 months of age|Three doses control wIPV at the schedule of 2,3,4 months of age
15807667|NCT04386694|Device|Active PBMT/sMF|The PBMT/sMF will be irradiated in the lower thorax and neck areas, with the patients in supine position. PBMT/sMF application time will be 60 seconds per site. The dose used in the lower thorax will be 31.50 J per site, a total of 6 sites will be irradiated, totalizing a dose of 189J. In addition, the dose used in the neck area (bilaterally) will be 31.50J per site, a total of 1 site (bilaterally) will be irradiated, totalizing a dose of 31.50J (bilaterally). PBMT/sMF will be applied using the direct contact method with light pressure on the skin.
15807668|NCT04386694|Device|Placebo PBMT/sMF|The placebo PBMT/sMF will be irradiated in the lower thorax and neck areas, with the patients in supine position. PBMT/sMF application time will be 60 seconds per site. The dose used for applications during the treatment will be 0 Joules (J) per site. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (active or placebo). PBMT/sMF will be applied using the direct contact method with light pressure on the skin.
15807669|NCT04386681|Behavioral|Reentry Continuum for Brain Injury (RCBI)|"Pre-Release RCBI Treatment Procedures (BICS and ICAN). BICS: consists of 12 weekly two- hour sessions. Sessions focus on brain injury education, coping skills for the various symptoms of brain injury, depression management, stress management, and self- advocacy.
~ICAN: delivered once a week for 6 weeks for 2 hours per session. ICAN primarily focuses on poor perspective-taking and inability to make social inferences about others' behaviors that are related to negative attributions, and employs role playing exercises and a novel perspective-positioning technique to elicit affective and cognitive empathy to alter negative attributions and reduce anger.
~Post-Release RCBI Resource Facilitation. Working with their resource facilitator, alongside their corrections case manager, to work on brain injury specific reentry planning, resource, and needs identification."
15807670|NCT04386668|Other|Let It Out (LIO)-C|Participants complete three online 20-minute writing sessions in response to prompts asking them to write about their experiences during the COVID19 pandemic from a self-compassionate perspective
15807671|NCT04386668|Other|Neutral writing control|Participants complete three online 20-minute writing sessions in response to neutral writing prompts
15807672|NCT04386655|Behavioral|Brain Injur Coping Skills - Telemedicine|"BICS sessions (both in-person and telemedicine) will occur once a week for 12 weeks. Each session will last two hours.
~Modules of BICS include: Introduction to Brain Injury, Expectations for Recovery, Tips on Managing Challenging Problems, Learning about Depression after the Brain Injury, The 4 R's of Stress Management, Communicating Effectively with Professionals"
15807673|NCT04386642|Drug|Tranexamic acid|Tranexamic acid 2000 mg dilute in normal saline solution 50 ml.
15807674|NCT04386642|Drug|Placebo|normal saline solution in a clear 50-ml syringe
15807675|NCT04386616|Drug|MSTT1041A|Participants will receive up to 2 intravenous infusions of MSTT1041A.
15807676|NCT04386616|Drug|MSTT1041A-matched Placebo|Participants will receive up to 2 intravenous infusions of MSTT1041A-matched placebo.
15807677|NCT04386616|Drug|UTTR1147A|Participants will receive up to 2 intravenous infusions of UTTR1147A.
15807678|NCT04386616|Drug|UTTR1147A-matched Placebo|Participants will receive up to 2 intravenous infusions of UTTR1147A-matched placebo.
15807679|NCT04386590|Other|Manual Therapy Plus Pulmonary Rehabilitation|Manual therapy combined with Pulmonary Rehabilitation
15807680|NCT04386590|Other|Sham Intervention|Detuned US plus Pulmonary Rehabilitation
15807681|NCT04386577|Dietary Supplement|Vitamin D3 (cholecalciferol)|Eligible participants were assigned by chance to one of four groups: (1) daily vitamin D3 and omega-3; (2) daily vitamin D3 and omega-3 placebo; (3) daily vitamin D placebo and omega-3; or (4) daily vitamin D placebo and omega-3 placebo. At baseline, year 2 and year 4 of the trial, a subcohort of 1,054 VITAL participants living within driving distance of Boston, Massachusetts received detailed in-clinic health assessments at the Clinical and Translational Science Center (CTSC) of Brigham and Women's Hospital. During CTSC visits, participants have a clinical exam, including measurement of height, weight, other anthropometrics, blood pressure, and physical performance. They also provide fasting blood and urine samples, and undergo 2-hour oral glucose tolerance testing, lung function testing (spirometry), electrocardiograms, bone mineral density testing, 2D-echocardiography, and assessments of thinking and mood.
15807682|NCT04386577|Drug|fish oil|Eligible participants were assigned by chance to one of four groups: (1) daily vitamin D3 and omega-3; (2) daily vitamin D3 and omega-3 placebo; (3) daily vitamin D placebo and omega-3; or (4) daily vitamin D placebo and omega-3 placebo. At baseline, year 2 and year 4 of the trial, a subcohort of 1,054 VITAL participants living within driving distance of Boston, Massachusetts received detailed in-clinic health assessments at the Clinical and Translational Science Center (CTSC) of Brigham and Women's Hospital. During CTSC visits, participants have a clinical exam, including measurement of height, weight, other anthropometrics, blood pressure, and physical performance. They also provide fasting blood and urine samples, and undergo 2-hour oral glucose tolerance testing, lung function testing (spirometry), electrocardiograms, bone mineral density testing, 2D-echocardiography, and assessments of thinking and mood.
15807683|NCT04386564|Diagnostic Test|mRNA in urine test|Assessment of renal function, expression of viral RNA in urine and assessment of radiological changes will be performed
15807684|NCT04386538|Behavioral|Low Starch Diet (LSD)|6-week balanced diet program, adapted to individual energetic needs, with significant reduction of high content starchy food, naturally present in plant cells, roots, tubers, seeds, beans, legumes, fruits, and highly present in most farinaceous grains, especially in potatoes, corn, rice, pasta, bread, cookies and cakes.
15807685|NCT04386538|Behavioral|General healthy eating|6-week balanced healthy eating counseling program, according to the World Health Organization recommendations.
15807686|NCT04386525|Dietary Supplement|Omega-3 fish oil|soft gels,1000gm, 84% of DHA and EPA
15807687|NCT04386499|Dietary Supplement|Resveratrol|mixture of trans-resveratrol 150 mg (REVIFAST), folic acid 400 mcg, vitamin D, vitamin B12 and vitamin B6
15807688|NCT04386499|Dietary Supplement|Folic acid|400 mcg of folic acid
15807689|NCT04386486|Other|Bathe anamnesis method|BATHE anamnesis (BA) is applied to first group and preoperative examinations are completed.
15808262|NCT04381689|Biological|Fluarix Tetra Pre-filled Syringe|Fluarix Tetra Pre-filled Syringe 0.5mL
15807690|NCT04386486|Other|standart anamnesis|standart anamnesis is applied to second group and preoperative examinations are completed.
15807691|NCT04386473|Device|pacemaker|electrode is implanted in left bundle branch in LBBP; electrode is implanted in right ventricular outflow tract septal in RVOP
15807692|NCT04386447|Drug|Oxytocin|In addition to standard treatment, patients in the experimental arm will receive intravenous OT with dilution of 25 UI or 40 UI OT in 500cc physiological solution NaCl 9%. OT will be administered with continuous pump infusion with 62,5 ml/h. The clinician will have the option to decrease infusion speed based on significant variations in arterial pressure, otherwise, the total 25 UI or 40 UI amount will be infused in 8 hours. Treatment duration will be 10 days
15807693|NCT04386447|Drug|Standard of Care|"Standard of Care (SoC). Standard of Care will comply with the indications of the Emilia-Romagna Region for the treatment of covid-19, and will include the following:
~Oxygen supply or non-invasive ventilation to target peripheral blood saturation > 94%
~Hydroxychloroquine 200mg b.i.d w/o an initial 1-2 days loading dose of 400 mg bid for 1-2 days (the dose may be reduced in patients with advanced CKD according to local protocols) or remdesivir 200 mg in.v on day 1, followed by a 100 mg q.d.
~Antiretroviral therapy (usually for 5 days) with lopinavir / ritonavir or darunavir / cobicistat is permitted
~Azithromycin 500 mg q.d., usually for 5 days, is permitted in patients with suspected bacterial superinfection, paying particular attention to safety, considering reports of risk of adverse events in association with hydroxychloroquine
~Prophylaxis for deep vein thrombosis
~Steroids are not routinely recommended but may be considered in selected patients."
15807694|NCT04386434|Behavioral|Active for Life: Assisted Living|"Each intervention session will take place within the assisted living facility twice a week for 12 weeks.
~Sessions will begin with 5-10 minutes of walking in the hallway. Participants will be encouraged to walk at their own pace and allowed to take breaks if needed.
~Next, behavioral strategies based on the construct of self-efficacy from social cognitive theory and education about physical activity will be delivered. This component is scheduled between the walking and circuit training, lasts 15-20 minutes, and serves as a rest period.
~Circuit training will focus on strength and balance. Approximately 8 exercise stations will be set up, and the exercises performed at each station will be changed approximately every 4 weeks. The circuit training will last ~30-40 minutes, with participants moving from one station to the next at their own pace and taking breaks in between."
15807695|NCT04386421|Other|Video on oral hygeine instructions|A 3 minute video will be shown providing information regarding the care of the dentition during Fixed appliance treatment along with the importance of patient compliance and cooperation. The video will also be showing the consequences of poorly followed instructions such as gingivitis and white spot lesions.
15807696|NCT04386421|Drug|Plaque disclosing tablets|"Plaque disclosing tablets:
~Product: 2-Tone Disclosing Tablets Young Dental Manufacturing 13705 Shoreline Court East Earth City, MO 63045 Composition: Flavor, SD Tutti Fruiti 1 %, D and C Red 1 % and FD and C Blue 1 %"
15807697|NCT04386408|Combination Product|Combination of plant extracts (BSL_EP027)|Each participant will consume a sachet disolve in water once at day without any restriction in the diet nor in their habits of life.
15807698|NCT04386408|Combination Product|Placebo|Each participant will consume a sachet disolve in water once at day without any restriction in the diet nor in their habits of life.
15807699|NCT04386382|Procedure|ridge splitting flapless technique using interchangeable guide followed by implant placement|"An informed consent is taken from all the patients
~I. Presurgical phase:
~Proper dental and medical history.
~Scaling and oral hygiene measurements.
~Clinical examination.
~Radiographic examination. Clinical bucco-lingual measurements was done using calipers to ensure the patients would meet our initial inclusion criteria prior to further investigations.
~III. Fabrication of interchangeable surgical guide stent from primary impression:
~Optical scanning of the dental casts was done using Ceramill map 400
~surgical stent was designed using Mimics Innovation Suite 19 ™ software.
~Series of creating and designing special 3D virtual guide slits and boxes that can accommodate and precisely fit the tools used for the ridge splitting technique.
~All patients will be operated under local anesthesia, stent was placed on ridge and adapted well after disinfection osteotomy was done using piezotome splitting tips Implant-insertion was started immediately"
15807700|NCT04386369|Other|Airway pressure release ventilation|Ventilator management strategy
15807701|NCT04386356|Device|Orotracheal intubation with either Macintosh laryngoscope versus Airtraq video laryngoscope|Tracheal intubation will be performed by first year anaesthesia trainee using either Macintosh laryngoscope or Airtraq video laryngoscope according to the randomization sequence supervised by an experienced anaesthesiologist and data recorded by an independent observer on one group of patients.
15807702|NCT04386343|Drug|CH1701 for prevention and treatment of radiation burns.|Ch1701 is used for cancer patients who are treated with radiotherapy, then assess the safety and treatment effectiveness of the product.
15807703|NCT04386343|Drug|Safety assessment of CH1701|Safety assessment of CH1701 after 14 days of use on volunteers
15807704|NCT04386343|Drug|Placebos|The placebo was used on patients as a control for the doses of CH1701
15807705|NCT04386330|Behavioral|Distance-delivered NET|One-on-one intervention delivered by a paraprofessional; 12 weekly videoconference sessions at 90 minutes.
15807706|NCT04386317|Drug|Terazosin|Fifteen patients with defined pre-motor PD risk and abnormal baseline 123I-MIBG uptake, with or without 123I-Ioflupane uptake abnormality or PD motor symptoms, will be recruited to receive daily oral doses of terazosin 5 mg or 10 mg. The dosage of terazosin will be gradually increased from the initial recommended starting dose of 1 mg daily at bedtime and titrated stepwise to 2mg, 5mg or 10 mg weekly, according to patient tolerability, as measured by subjective complaints, arterial blood pressure and heart rate. The target dose will be 5 mg or 10 mg daily based on subject's tolerability. Development of incompatibility will be addressed by individually adjusting the dose of terazosin.
15807707|NCT04386304|Drug|(+)-Epicatechin|(+)-Epicatechin is a synthetic flavanol
15807708|NCT04386291|Behavioral|Anxiety Reduction Training|Educational material will be provided every two weeks that address different aspects of anxiety and cognitive-behavioral approaches to reduce anxiety and stress.
15807709|NCT04386291|Behavioral|Kundalini Yoga and Anxiety Reduction Training|Daily practice of Kundalini Yoga (light stretching, breathing exercises, and meditation) guided by on-line video instruction, as well as the biweekly anxiety reduction psychoeducation.
15807710|NCT04386291|Behavioral|Meditation and Anxiety Reduction Training|Daily practice of meditation (muscle relaxation, breathing, and meditation) guided by on-line video instruction, as well as the biweekly anxiety reduction psychoeducation.
15807711|NCT04386278|Device|Intervention 1|Side one: No treatment Side two: OrthoPulse Gen 2 (2RP) for one minute
15807712|NCT04386278|Device|Intervention 2|Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for one minute
15807713|NCT04386278|Device|Intervention 3|Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RP) for 5 minutes
15807714|NCT04386278|Device|Intervention 4|Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (2RCW) for five minutes
15807715|NCT04386278|Device|Intervention 5|Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute
15807716|NCT04386278|Device|Intervention 6|Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for five minutes
15807717|NCT04386278|Device|Intervention 7|Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RB 2RL) for one minute
15807718|NCT04386278|Device|Intervention 8|Side one: OrthoPulse (approved device) Side two: OrthoPulse Gen 2 (3RBP) for five minutes
15807719|NCT04386252|Biological|AV-COVID-19|Autologous dendritic cells previously loaded ex vivo with SARS-CoV-2 spike protein
15807720|NCT04386239|Drug|Sarilumab Prefilled Syringe|Sarilumab administration must be associated with an antiviral treatment as defined by the treatment protocol suggested by the SIMET Experts group 4 and AIFA recommendations: chloroquine 500 mg 1 tablet twice daily or hydroxychloroquine 400 mg 1 tablet twice daily in the first day and then 200 mg 1 tablet twice daily.
15807721|NCT04386226|Dietary Supplement|Ambrotose LIFE|Ambrotose LIFE contains aloe vera extract inner leaf gel, arabinogalactin, ghatti gum, glucosamine hydrogen chloride, gum tragacanth, vitamin A, beta carotene, wakame algae extract, rice starch, RiFiber (rice bran), and Modified Citrus Pectin with Sodium Alginate.
15807722|NCT04386226|Dietary Supplement|Advanced Ambrotose|Advanced Ambrotose contains aloe vera extract inner leaf gel, arabinogalactan, ghatti gum, glucosamine hydrogen chloride, gum tragacanth, vitamin A, beta carotene, wakame algae extract, and rice starch
15807723|NCT04386226|Other|Placebo|Maltodextrin
15807724|NCT04386213|Device|coronary artery in-stent restenosis|treat the petients with coronary artery in-stent restenosis
15807725|NCT04386200|Other|web-based thecnologies|"Integration of traditional face-to-face educational approach with web-based technologies."
15807726|NCT04386200|Behavioral|traditional approach|"traditional face-to-face educational approach"
15807727|NCT04386187|Other|GSH Foods|The intervention consists of customized foods/small meals that have been designed to be high in a single nutrient called glutathione (GSH).
15807728|NCT04386187|Other|Nutrition education about glutathione sources in the diet|Four videos will outline food sources of glutathione, cooking methods to reduce systemic requirements for glutathione, food sources of nutrient cofactors for glutathione production and other related content.
15807729|NCT04386187|Other|Standard of care nutrition education for type 2 diabetes|The educational control is provided with information on standard dietary interventions for diabetes as electronic handouts and web links.
15807730|NCT04386174|Other|Neurofeedback|Information about activity in pain-related regions of the brain will be shown to participants to determine if receiving this information is helpful in learning different thinking strategies (such as shifting attention, imagery, mantra meditation, etc.) that may help people with SCI change their experience of neuropathic pain.
15807731|NCT04386161|Other|Scheduled exercise program|45 minutes of stretching, strengthening, and balance-coordination exercises and 20 minutes of balance training on the Balance Master® device twice a week for six weeks
15807732|NCT04386148|Procedure|Obsidian ASG®|As part of the elective laparoscopic colorectal surgery, an autologous fibrin matrix was used as part of anastomotic technique in conjunction with activated thrombocytes (Obsidian ASG®). During anastomosis, this matrix was applied after resection onto the colorectal tissue surfaces with the aim of triggering tissue regeneration and improved wound healing.
15807733|NCT04386122|Drug|FABALOFEN 60|Dosage: Single dose of one tablet of test product in each period. Administration: 30 minutes before administration, subjects will receive a test meal (high-fat and high-calorie) and finish this meal in 30 minutes or less. Take 1 tablet of test product with 240 mL of water. Lying position or strenuous activities are not allowed within 2 hours post dose
15807734|NCT04386122|Drug|JAPROLOX TABLET|Dosage: Single dose of one tablet of reference product in each period. Administration: 30 minutes before administration, subjects will receive a test meal (high-fat and high-calorie) and finish this meal in 30 minutes or less. Take 1 tablet of reference product with 240 mL of water. Lying position or strenuous activities are not allowed within 2 hours post dose
15807735|NCT04386109|Other|No intervention - exposure is to COVID-19|No intervention - exposure is to COVID-19
15807736|NCT04386096|Other|Mehealth for ADHD software with medication continuity tools|Medication continuity tools integrated within the mehealth for ADHD software will assess factors influencing medication continuity for each adolescent and recommend tools to address relevant factors. Tools include 1) a system to track outcomes and resolve uncertainty about the need for and/or benefit from medicine, 2) a module to address stigma, 3) a module to help manage side effects, and 4) reminders to take medicine and/or request refills.
15807737|NCT04386096|Other|Mehealth for ADHD software with no medication continuity tools|"The mehealth for ADHD software has multiple functionalities including 1) online training regarding the American Academy of Pediatrics (AAP) ADHD guidelines; 2) an ADHD workflow wizard that guides pediatricians through the creation of an efficient office workflow to deliver quality ADHD care; 3) online collection of parent- and teacher-report ADHD rating scales for the assessment of ADHD as well as monitoring response to medication treatment; 4) integrated algorithms that automatically score rating scales in real time and provide pediatricians with assessment and treatment reports as well as immediate warnings; 5) an online pediatrician report card; and 6) a Plan-Do-Study-Act wizard that allows pediatricians to select a practice behavior to improve based on their report card and guides them through the creation of small tests of change to improve their office systems."
15807738|NCT04386070|Drug|RESP301|RESP301 is a formulation consisting of three agents already used in clinical practice: mannitol, sodium nitrite and citric acid. Delivered by a vibrating mesh nebuliser three times per day (TID) (at least 4 hours apart), for 7 days. Each dose of RESP301 is a 6ml admixture of 150mM NaNO2, 50mM mannitol and 100mM citric acid, buffered at pH 5.4.
15807739|NCT04386057|Drug|Hydroxychloroquine Sulfate|HCQ will be administered by mouth twice daily continuously throughout each treatment per 28 day cycle
15807740|NCT04386057|Drug|LY3214996|LY3214996-daily oral dosage per protocol per 28 day cycle
15807741|NCT04386031|Diagnostic Test|Throat culture for fungal pathogens|Throat culture for fungal pathogens will be taken before surgery, at post-operative day (POD) 3 and 2 weeks after the operation
15807742|NCT04386005|Device|Continuous Glucose Monitoring Device|The Dexcom G6 Glucose Monitoring System (San Diego, CA) reports continuous interstitial blood glucose concentrations every 5 minutes, does not require calibration, and involves only 1 needle stick to place the sensor. The manufacturer recommends that a single sensor may be used for up to 10 days. The Dexcom G6 system is the only FDA approved CGM system for children (age >2 years).
15807743|NCT04385992|Drug|177Lu-Dotatate|Peptide Receptor Radionuclide Therapy (PRRT) is based on specific somatostatin receptor targeting with radiolabelled analogues 90Y-DOTATOC and 177Lu-DOTATATE
15807744|NCT04385979|Other|Gel|containing herbal Curcumin or NanoCurcumin
15807745|NCT04385966|Procedure|Interscalene brachial plexus block|Interscalene brachial plexus block is a locorregional anaesthesia technique which is indicated in shoulder and upper arm surgery. The goal of this block is to place the needle in the tissue space between the anterior and middle scalene muscles and inject local anesthetic until the spread around the brachial plexus is documented by ultrasound.
15807746|NCT04385966|Drug|Levobupivacaine Hydrochloride 2.5 MG/ML|"Levobupivacaine Hydrochloride 2.5 MG/ML is an anesthestic product intended for epidural, intradural and perineural administration. Levobupivacaine is chemically described as (S)-l-butyl-2-piperidylformo-2',6'-xylidide hydrochloride. It is a white crystalline powder with a molecular formula of C18H28N2O. HCl, with a molecular weight 324.9.
~FDA approval: NDA-20997 (1999)."
15807747|NCT04385953|Diagnostic Test|Quantra System|Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care
15807748|NCT04385940|Dietary Supplement|Ddrops® products, 50,000 IU, Oral|Vitamin D3
15807749|NCT04385940|Dietary Supplement|Vitamin D3|Vitamin D3 1000IU
15807750|NCT04385927|Behavioral|e-Net for Parents of Neurodiverse Children|One-on-one distance coached intervention; approx. 12 sessions at 60-90 minutes.
15807751|NCT04385914|Other|COVID positive via testing|Following pregnancy outcomes whether they are COVID positive or negative
15807752|NCT04385901|Behavioral|Therapy Intervention|Patients receive 2-4 visits (based on patient presentation and need) of physical therapy, up to 4 visits of occupational therapy, up to 4 visits of speech therapy based on need. Treatment focuses on physical strengthening, pulmonary strengthening/breathing exercises, and cognitive rehabilitation.
15807753|NCT04385888|Behavioral|Low-calorie sweetener restriction|Participants will avoid low-calorie sweetened beverages and other sources of low-calorie sweeteners for 12 weeks and will instead consume unsweetened alternatives, such as still or sparkling water
15807756|NCT04385849|Biological|N-803|Recombinant human super agonist interleukin-15 (IL-15) complex
15807757|NCT04385849|Other|Saline|Sterile saline solution
15807758|NCT04385836|Drug|alpha one antitrypsin inhalation|- we will give 8 ml of intravenous alpha one antitrypsin (alpha1-proteinase inhibitor (AATD)Glassia 50 ml) as nebulizer every 12 hours for 5 days
15807759|NCT04385823|Device|patients receiving nasal high flow|patients admitted to the ICU for Covid-19-related acute hypoxemic respiratory failure treated with nasal high flow
15807760|NCT04385810|Procedure|Ophthalmologic exam|Direct exam and Slit lamp exam Shirmer test Retinophotography At inclusion, day 7, day 14 and discharge from hospital
15807761|NCT04385797|Other|Telephone interview|Sociodemographic data. Clinical data. PMCI/MD quality of life, cognition, depression, technophilia and perceived stress and caregiver quality of life and burden assessments.
15807762|NCT04385784|Other|Balance exercise program.|Multimodal exercise program that combines strength, mobility, elasticity and postural control exercises. It develops once a week for a total of 24 weeks. Each session lasts one hour and is carried out in small groups of 8 to 10 people maximum.
15807763|NCT04385784|Other|Home-based exercise program.|Exercises based on the OTAGO program that are carried out at home without supervision. Participants are explained to carry out the program three or four times a week in a safely way.
15807764|NCT04385771|Device|vv-ECMO + cytokine adsorption (Cytosorb adsorber)|in COVID-19-diseased vv-ECMO patients additional treatment with cytokine adsorption using a Cytosorb adsorber will be randomized (vs. control group)
15807765|NCT04385771|Device|vv-ECMO only (no cytokine adsorption)|COVID-19-diseased treated with vv-ECMO
15807766|NCT04385758|Other|Diabetes-REM Program|A comprehensive community paramedicine management program designed to support adults with uncontrolled diabetes and a recent emergency department visit or hospitalization
15807767|NCT04385745|Procedure|Biodegradable Intramedullary Nailing (BIN)|Unstable forearm shaft fractures are treated by the study method (BIN) or the control method (ESIN).
15807768|NCT04385732|Device|2D or 3D Melanoma Surveillance Photography|Total body imaging using 2D or 3D Melanoma Surveillance Photography.
15807769|NCT04385719|Drug|Remdesivir|Remdesivir (GS-5734) is a nucleoside analogue with in vitro activity against filoviruses EBOV, SUDV, BDBV and MARV, in addition to arenaviruses and coronaviruses
15807770|NCT04385706|Behavioral|Applied Coaching Model|The Applied Coaching Model incorporates key learning opportunities and coaching strategies with evidence-based practices, approaches and theories and will serve as a tool for all healthcare providers wanting to implement coaching techniques within their practice.
15807771|NCT04385693|Procedure|Pulpotomy|Pulpotomy using bioactive bioceramic cement of 1.5 mm layer of a newly FDA approved calcium-based silicate cement (Nusmile NeoPutty) will be placed on the pulp chamber floor and canals' orifices for pulp and root therapy. Pulpotomy is a procedure in which the coronal pulp is amputated, and the remaining radicular pulp tissue is treated with a medicament to preserve the pulp's health.This technique involves administration of local analgesia, Isolation of the tooth with rubber dam, complete caries removal and then access to the pulp chamber using drills.
15807772|NCT04385693|Procedure|Extraction and placement of space maintainer|If during the pulpotomy procedure, hemostasis is not obtainable, or signs of advanced pulp degeneration such as dark and limited or no bleeding from canals, the pulp will be diagnosed as chronically inflamed or necrotic, and tooth will be extracted. As part of the standard of care after extractions of primary molars, space maintenance will be assessed, and a space maintainer fabricated if indicated. Extracted teeth will serve as controls, and information regarding the need or not of space maintenance.
15807773|NCT04385680|Drug|Chlorhexidine Gluconate vaginal solution 0.05%|preoperative vaginal preparation
15807774|NCT04385667|Device|levonorgestrel intrauterine system (LNG-IUD)|progestin delivery for regression of atypical endometrial hyperplasia
15807775|NCT04385667|Drug|Oral Megesterol 160 mg daily|progestin delivery for regression of atypical endometrial hyperplasia
15807776|NCT04385654|Drug|Toripalimab|Toripalimab (240 mg,ivgtt,q3w) was administered to patients for 6 weeks and underwent surgery within 2-4 weeks
15807777|NCT04385654|Drug|Axitinib|Axitinib (5 mg,po,qd) was administered to patients for 6 weeks and underwent surgery within 2-4 weeks
15807778|NCT04385641|Other|Cell infusion for Dose-finding (Group A)|Group A：HLA-I and HLA-II molecular typing were performed at the serological and molecular levels, and the HLA-I and HLA-II molecular antigens of donor and subjects match on 3, 4, 5 or 6 / 6. After the successful matching, the non myeloablative immunosuppressive pretreatment with cyclophosphamide (900 mg / m＾2 / day) and fludarabine (30 mg / m＾2 / day) will be performed 6, 5, 4 and 3 days before the infusion of UCB-NK cells. After the pretreatment, the cell infusion was started on day 0, and the cell infusion could be divided into 50% and 50% for two consecutive days or every other day. To ensure clinical safety, if treatment-related adverse events reach DLT after the first infusion, the cell infusion will stop.
15807779|NCT04385641|Other|Cell infusion for Extended research (Group B)|Group B：Non myeloablative immunosuppressive pretreatment and cell transfusion were the same as group A.
15807780|NCT04385628|Behavioral|the patient' relatives satisfaction questionnaire|The patient' relatives satisfaction questionnaire will be filled face to face during informing the patient's relatives after the 3rd, 10th, and 30th days of patient admission, and once a month. We will evaluate the most recent questionnaire.
15807781|NCT04385615|Other|Fasting Mimicking Diet|Participants will be requested to follow three cycles (of 5 day each), for three consecutive months, of a Fasting Mimicking Diet, a plant-based, low-calorie, low-protein, low-carbohydrate, high-unsaturated fat diet. For the remaining 25 days of each month, participants should continue with their habitual eating habits.
15807782|NCT04385602|Drug|Intratracheal dexmedetomidine|Thirty minutes before the end of the surgery, Dex (0.5μg/kg diluted and mixed in 1ml saline in a medical spray bottle) will be sprayed down the intratracheal tube
15807783|NCT04385602|Drug|Saline Solution|Thirty minutes before the end of the surgery, 1ml saline in a medical spray bottle will be sprayed down the intratracheal tube
15807784|NCT04385589|Drug|Dapagliflozin|Patient will receive oral Dapagliflozin then monitoring of its efficacy on heart failure symptoms and outcome.
15807785|NCT04385589|Drug|insulin|insulin
15807786|NCT04385576|Device|Aerosol Box|Usage of an Intubation Box to minimize intubator and environment contamination during intubation and extubation. Time taken for first-pass success if also expected to be reduced with the usage of the Intubation Box.
15807787|NCT04385576|Device|Intubation Box|Usage of an Intubation Box to minimize intubator and environment contamination during intubation and extubation. Time taken for first-pass success if also expected to be reduced with the usage of the Intubation Box.
15807788|NCT04385563|Drug|TQ-B211|Participants will receive TQ-B211 8 milligrams/kilogram (mg/kg) intravenously(iv.) on day 1 in Cycle 1 followed by 6 mg/kg iv.on day 1 in Cycles 2 to 8.
15807789|NCT04385563|Drug|Herceptin®|Participants will receive Herceptin® 8 milligrams/kilogram (mg/kg) intravenously(iv.) on day 1 in Cycle 1 followed by 6 mg/kg iv.on day 1 in Cycles 2 to 8.
15807790|NCT04385563|Drug|docetaxel|Participants will receive docetaxel 75 milligrams/square meter (mg/m^2) iv.on day 2 in Cycle 1 followed by 75mg/m^2 iv.on day 1 in Cycles 2 to 8.
15807791|NCT04385550|Drug|Anlotinib hydrochloride capsule|Anlotinib hydrochloride capsule 12mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
15807792|NCT04385550|Drug|AK105 injection|AK105 200mg intravenously (IV) on Day 1 of each 21-day cycle.
15807793|NCT04385550|Drug|Paclitaxel injection|Paclitaxel injection 80mg / m² IV on Days 1, 8 and 15 of each 28-day cycle.
15807794|NCT04385550|Drug|Docetaxel injection|Docetaxel injection 75mg / m² IV every 3 weeks of each 21-day cycle.
15807795|NCT04385537|Dietary Supplement|PECAN|Raw pecan halves without other changes to their habitual diet.
15807796|NCT04385524|Biological|Adjuvanted Hepatitis B Vaccine|Adjuvanted Hepatitis B vaccine will be provided to healthcare workers previously vaccinated with the standard 3-dose series of Hepatitis B vaccine but who have failed to respond to two complete 3-dose series
15807797|NCT04385511|Device|supraglottic jet ventilation|patients who were randomized into supraglottic jet ventilation group would be placed Wei Nasal Jet Tube after conducted. Then they will get the supraglottic jet ventilation to make sure their pulse oximetry is over 95%. After 3 minutes, endotracheal intubation was performed via mouth approach.
15807798|NCT04385498|Behavioral|BREATHE Intervention|5 session program focusing on breathing retraining, psychoeducation, and positive coping.
15807799|NCT04385498|Behavioral|Treatment as Usual|Typical primary care treatment which will include medication management and follow-up at the health facilities, at at least the same frequency as treatment arm.
15807800|NCT04385485|Procedure|Active rehabilitation|We investigate if active rehabilitation is as good as passive rehabilitation after flexor tendon suture.
15807801|NCT04385485|Procedure|Passive rehabilitation|We investigate if active rehabilitation is as good as passive rehabilitation after flexor tendon suture.
15807802|NCT04385472|Radiation|3T MRI|The main method used will be 3 Tesla MRI, which is a high resolution imaging technique. The participants will be asked to undergo musculoskeletal MRI scanning (pelvis and lumbar spine).MRI is a non-invasive procedure which excludes the risk of radiation (in comparison to other imaging modalities: X-ray, CT
15807803|NCT04385459|Other|Coronary artery disease|Exposure
15807804|NCT04385446|Procedure|Amniotic membrane transplantation|Amniotic membrane transplantation was used as covering material during pterygium surgery.
15807805|NCT04385433|Drug|EXPERIMENTAL ARM|"Patients in the experimental arm will receive:
~Daily pravastatin (40mg/d) during 12 months (pravastatin initiation: first day of radiotherapy).
~Standard adjuvant whole breast radiotherapy (50Gy/ 25 fractions to whole breast) followed or not by a boost to tumor bed (16Gy/ 8 fractions)."
15807806|NCT04385433|Other|CONTROL GROUP|"Patients in the standard arm will receive:
~Daily placebo during 12 months (placebo initiation: first day of radiotherapy)
~Standard adjuvant whole breast radiotherapy (50Gy/ 25 fractions to whole breast) followed or not by a boost to tumor bed (16Gy/ 8 fractions)."
15807807|NCT04385433|Radiation|Standard adjuvant whole breast radiotherapy (50Gy/ 25 fractions to whole breast) followed or not by a boost to tumor bed (16Gy/ 8 fractions)|Radiotherapy will last 5 weeks during treatment by Pravastatine or Placebo
15807808|NCT04385420|Drug|ATR-002 MEK Inhibitor|Drug ATR-002 administered as film-coated tablet via oral route
15807809|NCT04385420|Drug|Placebo oral tablet|Placebo film-coated tablet administered via oral route
15807810|NCT04385407|Drug|Sofosbuvir + Simeprevir + Ribavirin|
15807811|NCT04385381|Device|URECA CTO device|facilitating guidewire re-entry into the true lumen after passing occlusion(s) in the peripheral vasculature with the URECA CTO device.
15807814|NCT04385355|Device|Conventional transmucosal abutment design|The macroscopic design of the intermediate transmucosal abutment will be evaluated on terms of the marginal peri-implant bone levels using two identical devices, if only being the test device narrower than the control one
15807815|NCT04385355|Device|Narrow transmucosal abutment design|The macroscopic design of the intermediate transmucosal abutment will be evaluated on terms of the marginal peri-implant bone levels using two identical devices, if only being the test device narrower than the control one
15807816|NCT04385342|Drug|FSH|Controlled ovarian stimulation by FSH followed by HMG versus FSH plus HMG
15807817|NCT04385342|Drug|HP-hMG|Controlled ovarian stimulation by FSH followed by HMG versus FSH plus HMG
15807818|NCT04385329|Other|Shock wave therapy on plantar fascia extended to the gastrocnemius-soleus trigger points|Enrolled subjects were treated with focused shock wave therapy, once a week for three consecutive weeks, by a specialized physician with more than five years of expertise, using a device powered by a piezoelectric generator (PIEZOSON 100PLUS, Richard Wolf®). At each treatment session, with the patients lying in prone decubitus position, the enthesis of the plantar fascia and the gastrocnemius-soleus trigger points were clinically targeted and treated with a perpendicular technique.
15807819|NCT04385329|Other|Shock wave therapy on plantar fascia only|Enrolled subjects were treated with focused shock wave therapy, once a week for three consecutive weeks, by a specialized physician with more than five years of expertise, using a device powered by a piezoelectric generator (PIEZOSON 100PLUS, Richard Wolf®). At each treatment session, with the patients lying in prone decubitus position, the enthesis of the plantar fascia was clinically targeted and treated with a perpendicular technique.
15807820|NCT04385316|Diagnostic Test|DNA extraction of samples and high-throughput sequencing of small panels|"DNA extraction of gastric tumor tissues and high-throughput sequencing of small panels were performed, and the relationship between the mutation spectrum of each sample and the corresponding patient clinical data (staging) was analyzed.
~DNA extraction of tumer tissue samples and blood sample and high-throughput sequencing of small panels,DNA extraction and small panel sequencing were performed for the two types of samples of the patients respectively, and the DNA sequencing results of the two types of samples were compared, and the clinical data of the corresponding patients were referenced to evaluate the consistency of the results of peripheral blood ctDNA and tissue gDNA for the gene detection of gastric tumor."
15807821|NCT04385316|Diagnostic Test|DNA extraction of samples and high-throughput sequencing of small panels|"DNA extraction of colorectal tumor tissues and high-throughput sequencing of small panels were performed, and the relationship between the mutation spectrum of each sample and the corresponding patient clinical data (staging) was analyzed.
~DNA extraction of tumer tissue samples and blood sample and high-throughput sequencing of small panels,DNA extraction and small panel sequencing were performed for the two types of samples of the patients respectively, and the DNA sequencing results of the two types of samples were compared, and the clinical data of the corresponding patients were referenced to evaluate the consistency of the results of peripheral blood ctDNA and tissue gDNA for the gene detection of colorectal tumor."
15807822|NCT04385316|Diagnostic Test|DNA extraction of samples and high-throughput sequencing of small panels|"DNA extraction of bladder tumor tissues and high-throughput sequencing of small panels were performed, and the relationship between the mutation spectrum of each sample and the corresponding patient clinical data (staging) was analyzed.
~DNA extraction of tumer tissue samples ,urine sample，blood sample and high-throughput sequencing of small panels,DNA extraction and small panel sequencing were performed for the three types of samples of the patients respectively, and the DNA sequencing results of the three types of samples were compared, and the clinical data of the corresponding patients were referenced to evaluate the consistency of the results of peripheral blood ctDNA ,urine ctDNAand tissue gDNA for the gene detection of bladder tumor."
15807823|NCT04385303|Drug|Lorecivivint|Healthcare professional-administered intra-articular injection; performed on Day 1
15807824|NCT04385303|Drug|Placebo|Healthcare professional-administered intra-articular injection; performed on Day 1
15807825|NCT04385290|Drug|MODULE: conventional chemotherapy (Cytarabine+Daunorubicin) in combination with midostaurin+GO|"Midostaurin (IMP) induction: 25 mg or 50 mg peroral BID, days 8 to 21 depending on assigned dose level
~GO (IMP) induction: 3 mg/m^2 i.v. max 4.5 mg, on day1, or on days 1, 4, or days 1, 4, 7 depending on assigned dose level
~Daunorubicin (DNR, non-IMP) induction: 60 mg/m^2/day i.v., days 1 to 3
~Cytarabine (AraC, non-IMP) induction: 200 mg/m^2/day cont. infusion, days 1 to 7"
15807857|NCT04385030|Device|TRANSCRANIAL DIRECT CURRENT STIMULATION AND MIRROR THERAPY|The study will consist of 12 sessions, carried out over a period of 1 month, with 3 weekly sessions on consecutive days, where each patient will receive ETCC for 30 minutes concomitantly with ET. Outcome assessments will be performed before the beginning of the protocol on the base (T0) and immediately after the end of the 12 sessions (T1).
15807858|NCT04385017|Other|COVID-19 patients|It will consist in the collection of 2 additional tubes at their blood draw. For DNA analysis, informed consent will be collected in writing
15807859|NCT04384991|Drug|HU007|Cyclosporine 0.02% with Trehalose 3%
15807860|NCT04384991|Drug|Restasis eye drop|Cyclosporine 0.05%
15807826|NCT04385290|Drug|MAGNOLIA-trial: Midostaurin associated with conventional chemotherapy (AraC+DNR)+GO|"Midostaurin (IMP):
~RP2D peroral, days 8 to 21, induction cycle 1; 50 mg peroral BID, days 8 to 21 induction cycle 2; 50 mg peroral BID, days 8 to 21, 3 consolidation cycles; 50 mg peroral BID, days 1 to 28, 12 maintenance cycles;
~GO (IMP): 3 mg/m^2 i.v. max 4.5 mg, RP2D, 1 induction cycle only
~Daunorubicin (DNR, non-IMP):
~60 mg/m^2 i.v., days 1 to 3 of induction cycle 1 and 2 in good and moderate responders; 50 mg/m^2/day i.v., days 1 to 3 of induction cycle 2 in non-responders
~Cytarabine (AraC, non-IMP):
~200 mg/m^2/day cont. infusion, days 1 to 7 of induction cycles 1 and 2 in good and moderate responders; 3000/1500 mg/m^2/day i.v. BID, days 1 to 3 of induction cycle 2 in non-responders; 3000/1500 mg/m^2 i.v. BID, days 1, 3, 5 of consolidation, 3 cycles"
15807827|NCT04385290|Drug|MAGNOLIA-trial: Placebo associated with conventional chemotherapy (AraC+DNR)+GO|"Placebo:
~peroral, days 8 to 21, 1-2 induction cycles; peroral BID, days 8 to 21, 3 consolidation cycles; peroral BID, days 1 to 28, 12 maintenance cycles;
~GO (IMP): 3 mg/m^2 i.v. max 4.5 mg, RP2D, 1 induction cycle only
~Daunorubicin (DNR, non-IMP):
~60 mg/m^2/day i.v., days 1 to 3 of induction cycle 1 and 2 in good and moderate responders; 50 mg/m^2/day i.v., days 1 to 3 of induction cycle 2 in non-responders
~Cytarabine (AraC, non-IMP):
~200 mg/m^2/day cont. infusion, days 1 to 7 of induction cycles 1 and 2 in good and moderate responders; 3000/1500 mg/m^2/day i.v. BID, days 1 to 3 of induction cycle 2 in non-responders; 3000/1500 mg/m^2 i.v. BID, days 1, 3, 5 of consolidation, 3 cycles"
15807828|NCT04385290|Drug|MAGMA-trial:GO associated with conventional chemotherapy (AraC+DNR)+Midostaurin|"Midostaurin (IMP):
~RP2D peroral, days 8 to 21, induction cycle 1; 50 mg peroral BID, days 8 to 21, induction cycle 2; 50 mg peroral BID, days 8 to 21, 3 consolidation cycles; 50 mg peroral BID, days 1 to 28, 12 maintenance cycles;
~GO (IMP): 3 mg/m^2 i.v. max 4.5 mg, RP2D, 1 induction cycle only
~Daunorubicin (DNR, non-IMP):
~60 mg/m^2/day i.v., days 1 to 3 of induction cycles 1-2 in good and moderate responders; 50 mg/m^2/day i.v., days 1 to 3 of induction cycle 2 in non-responders
~Cytarabine (AraC, non-IMP):
~200 mg/m^2/day cont. infusion, days 1 to 7 of induction cycles 1 and 2 in good and moderate responders; 3000/1500 mg/m^2/day i.v. BID, days 1 to 3 of induction cycle 2 in non-responders; 3000/1500 mg/m^2 i.v. BID, days 1, 3, 5 of consolidation, 3 cycles"
15807829|NCT04385290|Drug|MAGMA-trial: conventional chemotherapy (AraC+DNR)+Midostaurin|"Midostaurin (IMP):
~RP2D peroral, days 8 to 21, induction cycle 1; 50 mg peroral BID, days 8 to 21 induction cycle 2; 50 mg peroral BID, days 8 to 21, 3 consolidation cycles; 50 mg peroral BID, days 1 to 28, 12 maintenance cycles
~Daunorubicin (DNR, non-IMP):
~60 mg/m^2/day i.v., days 1 to 3 of induction cycle 1 and 2 in good and moderate responders; 50 mg/m^2/day i.v., days 1 to 3 of induction cycle 2 in non-responders
~Cytarabine (AraC, non-IMP):
~200 mg/m^2/day cont. infusion, days 1 to 7 of induction cycles 1 and 2 in good and moderate responders; 3000/1500 mg/m^2/day i.v. BID, days 1 to 3 of induction cycle 2 in non-responders; 3000/1500 mg/m^2 i.v. BID, days 1, 3, 5 of consolidation, 3 cycles"
15807835|NCT04385264|Drug|Hydroxychloroquine|Day 0: 800mg PO OD (4 capsules) Days 1-5: 400mg PO OD (2 capsules daily)
15807836|NCT04385264|Drug|Mannitol|Day 0: 4 capsules PO OD Days 1-5: 2 capsules daily PO OD
15807837|NCT04385251|Other|Data Collection|"DATA COLLECTION AT ENROLLMENT:
~Demographics; Symptoms and health status; Co-morbidities; Targeted medications; Specimen Collection (substudy at selected sites): Upper respiratory swab, blood for serum storage.
~DATA COLLECTION AT DAYS 7, 14 & 28:
~Vital and hospitalization status; Symptoms and health status"
15807838|NCT04385238|Other|This is an online survey with no intervention.|As this is an online survey about health and wellbeing, there is no intervention.
15807839|NCT04385225|Other|Longitudinal follow-up|Longitudinal hearing, vestibular and cognitive follow-up
15807840|NCT04385199|Biological|Convalescent plasma|One 200mL transfusion of ABO compatible convalescent plasma over 3 hours
15807841|NCT04385186|Drug|Inactivated convalescent plasma|"Day 0: Transfusion of 200mL of ABO -Rh compatible inactivated convalescent plasma, Start of support treatment selected by medical staff according to each institutional protocol
~Day 1: Transfusion of 200mL of ABO -Rh compatible inactivated convalescent plasma"
15807842|NCT04385186|Drug|Support treatment|Day 0: Start of support treatment selected by medical staff according to each each institutional protocol
15807843|NCT04385173|Drug|B7-H3 CAR-T|The B7-H3 CAR-T will be administrated via intratumoral or Intracerebroventricular injection through an Ommaya catheter in between Temozolomide cycles. Temozolomide will be stopped during the infusion of B7-H3 CAR-T
15807844|NCT04385173|Drug|Temozolomide|Temozolomide will be given to patients orally every 5 days with 23 days interval. The initial dose is 150 mg/m2 on the first day and 200 mg/m2 for the rest if no toxicity is seen. If 200 mg/m2 is toxic, the drug will return to 150 mg/m2 or will be stopped.
15807845|NCT04385147|Other|Endoscopic management according to standard of care|Endoscopic management according to standard of care by ERCP or EUS according to the indication in each case
15807846|NCT04385134|Other|No intervention|No intervention
15807847|NCT04385121|Other|Questionnary|Family member's will answer the questionnaires by phone
15807848|NCT04385108|Biological|Blood collection on admission and longitudinally|33 mL of blood collected on admission (day 0) and longitudinally (day 4, 8 12 and in discharge)
15807849|NCT04385108|Biological|Blood collection on their first consultation and 10 to 14 days later|33 mL of blood collected on their first consultation and 10 to 14 days later
15807850|NCT04385095|Drug|SNG001|SNG001 via inhalation
15807851|NCT04385095|Drug|Placebo|Placebo via inhalation
15807852|NCT04385082|Drug|Active Cannabis|Smoked cannabis with THC
15807853|NCT04385082|Drug|Placebo Cannabis|Placebo smoked cannabis (no THC)
15807854|NCT04385056|Biological|MSCTC-0010|MSCTC-0010 is a suspension product for infusion. The active ingredient is the umbilical cord-derived allogeneic mesenchymal stem cells (US-MSCs).
15807855|NCT04385043|Other|plasma hyperimmune|patients will receive this as add on therapy
15807856|NCT04385043|Drug|standard therapy|patients will receive only standard therapy for Covid-19 infection
15807861|NCT04384978|Behavioral|Play Serious Games with a Social Robot (Ryan)|Active Group: Game play and physical activities with Ryan, a socially assistive robot developed at DreamFace Technologies,LLC.
15808323|NCT04381104|Drug|Paracetamol|The intervention arm will receive 2 capsules of paracetamols of 500mg.
15807862|NCT04384978|Behavioral|Play Solitary Games Without a Social Robot|Control Group: Group 2 will play solitary games (e.g., word puzzles) and activities but will have no interaction with Ryan.
15807863|NCT04384965|Device|MagPro X100 Stimulator, B70 Fluid-Cooled Coil|Treatment will occur 8 times per treatment day (50 min pause between treatments). Each treatment session will consist of a single iTBS treatment, delivering 600 pulses of iTBS (bursts of 3 pulses at 50 Hz, bursts repeated at 5 Hz, with a duty cycle of 2 seconds on, 8 seconds off, over 60 cycles / ~3 minutes) at a target of 110% of the subject's resting MT.
15807866|NCT04384939|Device|magnetic-end Double-J ureteral stent|"Inserting the ureteral stent with magnet (same process as classic ureteral stent)
~Removing the ureteral stent with magnet without general anaesthesia. Usually, the classic ureteral stent removed during a general anaesthesia."
15807867|NCT04384926|Procedure|Elective Cancer Surgery|Planned, curative cancer surgery
15807868|NCT04384900|Procedure|Prone position ventilation|Patients are placed in a prone position using specialized equipment.
15807869|NCT04384887|Behavioral|covid-19 positive pregnant women|"It is planned to receive pregnant women who are admitted to the clinic or outpatient clinic and who are offered inpatient follow-up and treatment with the diagnosis of COVID-19.
~Pregnant women who do not have covid-19 disease as a control group and who do not have a comorbid disease at similar gestational week will be included in the study. As a control group, covid-19 pcr negative patients will be admitted to our clinic in the same period."
15807870|NCT04384874|Other|Exercise therapy|A 12 week multi-stage exercise rehabilitation program
15807871|NCT04384861|Behavioral|Mayo Clinic SMART program (Stress Management and Resilience Training)|The SMART program included a workshop and ongoing eLearning Support. The learning objectives of the workshop are: (1) learn the neuroscience and behavioural aspects of human experience, particularly with respect to stress, resiliency, performance and wellness and (2) learn practical approaches to enhance engagement and emotional intelligence and thereby decrease stress and anxiety, increase resilience, enhance performance, and improve relationships. The goal of the eLearning support is to support and reinforce the messages and techniques delivered in the 2-hour workshop.
15807872|NCT04384848|Other|EMPATHY Pilot|The goal of this pilot is to develop and pilot a tailored monitoring intervention targeting symptomatic, Patient-reported adverse events (AEs) in chronic myeloid leukemia (CML) Patients undergoing first-line tyrosine kinase inhibitor (TKI) therapy. The tailored monitoring intervention will draw primarily from the PRO-CTCAE Item Library, with additional items drawn from the FACIT and EORTC Item libraries as necessary. After identifying the full set of AEs to be monitored, we will load the Patient assessment and report program into tablets for electronic administration in the busy clinic setting. We will then pilot a six-month intervention aimed to monitor and manage emerging AEs, coupled with assessment of intervention feasibility, Patient acceptability and satisfaction, provider acceptability and clinical management utility, adherence to TKI therapy, and HRQoL. We expect that adherence to therapy, clinical response, and HRQoL will be enhanced by such an intervention.
15807873|NCT04384835|Biological|Blood sample collection (one tube)|Collection of one tube of 7.5 ml blood in addition to a blood sample made in clinical practice
15807874|NCT04384835|Biological|Blood sample collection (five tubes)|Collection of five tubes of 7.5 ml blood in addition to a blood sample made in clinical practice
15807875|NCT04384822|Behavioral|Tai Chi Group|Mind-body exercise intervention
15807876|NCT04384822|Behavioral|CBT-I Group|First-line clinically recommended non-pharmacological treatment of insomnia
15807877|NCT04384809|Biological|Leukocyte rich platelet rich plasma|Leukocyte rich platelet rich plasma will be obtained and prepared from a peripheral artery of the subject and then will be injected in the common extensor tendon
15807878|NCT04384809|Device|Percutaneous Tenotomy|Patients will undergo percutaneous tenotomy of the common extensor tendon using the Tenex tenotomy device
15807879|NCT04384783|Drug|growth hormone|growth hormone was adjuvanted 2IU/d from previous menstrual period for about six weeks.
15807883|NCT04384757|Procedure|Distal gastrectomy|Distal gastrectomy and standard D2 lymphadenectomy
15807884|NCT04384744|Drug|growth hormone|growth hormone was adjuvanted 2IU/d from previous menstrual period for about six weeks.
15807885|NCT04384731|Drug|poractant alfa|Patient receiving surfactant (3 mL/kg of a poractant alpha solution diluted to 16 mg/mL, resulting in a total dose of 48mg/kg) administred by bronchial fibroscopy. The total volume will be divided in each of the five lobar bronchi.
15807886|NCT04384705|Other|research specific blood sample|"one blood sample before the epidemic phase
~one blood sample during epidemic phase
~one blood sample after epidemic phase"
15807887|NCT04384692|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo HSCT
15807888|NCT04384692|Drug|Busulfan|Given IV
15807889|NCT04384692|Drug|Cyclophosphamide|Given IV
15807890|NCT04384692|Drug|Fludarabine|Given IV
15807891|NCT04384692|Drug|Melphalan|Given IV
15807892|NCT04384692|Drug|Methotrexate|Given IV
15807893|NCT04384692|Drug|Mycophenolate Mofetil|Given IV or PO
15807894|NCT04384692|Drug|Ruxolitinib|Given PO
15807895|NCT04384692|Drug|Tacrolimus|Given IV and PO
15807896|NCT04384692|Radiation|Total-Body Irradiation|Undergo TBI
15807897|NCT04384679|Device|Hydrophilic polymer and potassium ferrate powder|Application with pressure until hemostasis is achieved
15807898|NCT04384666|Drug|LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection)|LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection)
15807899|NCT04384666|Other|Neupro 4 mg / 24 Hr. Transdermal Patch|Neupro 4 mg /24 Hr. Transdermal Patch
15807900|NCT04384653|Drug|Furosemide Injection Solution for subcutaneous administration (80 mg)|Furosemide Injection Solution for subcutaneous administration (80 mg)
15808324|NCT04381091|Drug|Idebenone 150 MG Oral Tablet|idebenone 900 mg/day
15807901|NCT04384653|Drug|Furosemide Injection, USP|Furosemide Injection, USP (10 mg/mL), 80 mg by intravenous administration
15807902|NCT04384653|Device|Medfusion 3500 (v6) precision infusion pump|Furosemide Injection Solution for subcutaneous administration (80 mg)
15807903|NCT04384640|Other|Change of posture after Intra Tympanic injection|Seating position after Intra Tympanic injection
15807904|NCT04384627|Radiation|Delineating the GTV according to the pretreatment or post-IC tumor extension|Delineating the GTV according to the pretreatment or post-IC tumor extension
15807905|NCT04384614|Diagnostic Test|Test PCR|Viral load (COVID+) testing by PCR
15807906|NCT04384614|Genetic|TDR|IDR and blood sampling for testing DNA Cheque
15807907|NCT04384614|Other|Clinical Examination|COVID 19 symptoms and Physical Examination
15807908|NCT04384601|Drug|Chemotherapy|Perioperative chemotherapy will be administered according to description in two arms.
15807909|NCT04384588|Biological|Convalescent Plasma from COVID-19 donors|Patients that will participate in this clinical trial will be treated with Convalescent Plasma from COVID-19 donors regardless of the arm where they will be included
15807910|NCT04384575|Diagnostic Test|blind spots|missed part during map the entire stomach through endoscopy
15807911|NCT04384562|Drug|Methylphenidate|A 20 mg methylphenidate (Ritalin®) is administered only once for the dopamine reuptake inhibitor group.
15807912|NCT04384562|Drug|Reboxetine|A 4 mg reboxetine (Edronax®) is administered only once for the noradrenaline reuptake inhibitor group.
15807913|NCT04384562|Drug|Nicotine gum|A 2 mg nicotine (Nicorette®) gum is administered only once for the cholinergic receptor agonist group.
15807914|NCT04384562|Drug|Placebo pill|A placebo pill is administered only once.
15807915|NCT04384562|Drug|Placebo gum|A placebo gum is administered only once.
15807916|NCT04384549|Biological|BCG GROUP|One intradermal injection of 0.1 ml of BCG vaccine (AJ Vaccine).Each 0.1 ml vaccine contains between 2 to 8 x 105 colony forming units.
15807917|NCT04384549|Other|PLACEBO GROUP|One intradermal injection of 0.1ml NaCl
15807918|NCT04384536|Procedure|Neural therapy application|Local injections, C5-T8 segmental injections, trigger point injections of the forearm muscles and stellate ganglion injections are applied in each session, using a 27-gauge, 4-6 cm needle. The local injection is applied first in the first extensor compartment at the point of maximal tenderness and is directed proximally toward the radial styloid.trigger point is detected, approximately 5 mL lidocaine was injected to that point. C5-T8 segmental injections are applied intradermally to each spinous process and to 0.5-2 cm lateral of each process on the affected side. Finally, the stellate ganglion injection is applied using Fischer's modified technique.
15807919|NCT04384523|Drug|OsrHSA 20 mg/kg IV|A single dose of OsrHSA 20 mg/kg IV infusion at a rate lower than 2 ml/min
15807920|NCT04384523|Drug|OsrHSA 40 mg/kg IV|A single dose of OsrHSA 40 mg/kg IV infusion at a rate lower than 2 ml/min
15807921|NCT04384523|Drug|OsrHSA 80 mg/kg IV|A single dose of OsrHSA 80 mg/kg IV infusion at a rate lower than 2 ml/min
15807922|NCT04384523|Drug|OsrHSA 140 mg/kg IV|A single dose of OsrHSA 140 mg/kg IV infusion at a rate lower than 2 ml/min
15807923|NCT04384523|Drug|OsrHSA 200 mg/kg IV|A single dose of OsrHSA 200 mg/kg IV infusion at a rate lower than 2 ml/min
15807924|NCT04384523|Other|Placebo|Normal Saline (0.9% Sodium Chloride)
15807925|NCT04384510|Procedure|Planned Cesarean hysterectomy|This procedure refers to planned delivery of the fetus through Cesarean incision, leaving the placenta in situ and proceeding with hysterectomy
15807926|NCT04384510|Procedure|Conservative management|This term describes a single or combined intervention of uterine artery ligation, internal iliac artery ligation, prophylactic balloon placement in the aorta or internal iliac artery, uterine artery embolization, compression sutures, or excision and reconstruction of uterine wall
15807927|NCT04384497|Biological|SARS-CoV-2 convalescent plasma|Treatment with convalescent plasma (200ml, up to a maximum of 7 CP infusions). Plasma from consenting individuals who have recovered from SARS-CoV-2 infection.
15807932|NCT04384471|Other|Online survey|Participants are invited to answer an online questionnaire including both close-ended and open-ended questions about their experience during this sanitary crisis
15807933|NCT04384458|Drug|Hydroxychloroquine|Oral hydroxychloroquine 400 mg twice a day on day 1, one 400 mg tablet on day 2, 3, 4, and 5, followed by one 400 mg tablets every 05 days until day 50th associated with 66 mg of zinc sulfate.
15807934|NCT04384458|Drug|Ivermectin|Oral ivermectin dosage guidelines based on participant body weight, once on day for 2 consecutive days. This dose schedule should be repeated every 14 days for 45 days associated with 20 milligrams twice on day of active zinc.
15807935|NCT04384445|Biological|Zofin|Biological: Zofin will be administered intravenously with 1ml, containing 2-5 x 10^11 particles/mL in addition to the Standard Care. The Zofin dose will be diluted in 100 mL of sterile saline at subject's bedside.
15807936|NCT04384445|Other|Placebo|Other: Placebo Placebo (saline) will be administered intravenously with 1ml in addition to the Standard Care. The Placebo dose will be diluted in 100 mL of sterile saline at subject's bedside.
15807937|NCT04384432|Other|Routine Physical Therapy with Thoracic mobility exercise|Combınatıon of routıne Routine Physical Therapy with Thoracic mobility exercise
15807938|NCT04384432|Other|Routıne Physıcal therapy|Exercise for Chronic Neck Pain
15807939|NCT04384393|Biological|ThisCART19 cells|0.2-60 x 10^6 CAR T cells per kg body weight.
15807940|NCT04384380|Drug|Hydroxychloroquine Sulfate 200 MG [Plaquenil]|Hydroxychloroquine Sulfate is 400 mg bid on Day 1 and 200 mg bid for 6 days on Day 2-7.
15807941|NCT04384367|Drug|Rizatriptan 10 mg + Naproxen 550mg|oral - single dose
15807942|NCT04384367|Drug|Maxalt 10Mg Tablet|oral - single dose
15807943|NCT04384367|Drug|Flanax 550mg|oral - single dose
15807944|NCT04384367|Drug|Placebo oral tablet|oral - single dose
15807968|NCT04384133|Diagnostic Test|Fractional exhaled nitric oxide (FENO) test|In the FENO test, the participant is asked to perform respiratory maneuvers such as breathing deeply.
15807969|NCT04384133|Diagnostic Test|Thorax Computed Tomography|Computed tomography is a radiological examination.
15807945|NCT04384341|Radiation|Bone densitometry (BMD)|"Recruitment of haemophilic patients during a routine visit at the haemophilia centre.
~Information of the subjects that the study requires a BMD measure for all and a blood sampling for patients only.
~After inclusion and exclusion criteria have been checked, the subject can sign the consent.
~For all subjects, an appointment will be made for BMD measure.
~For patients and controls: BMD will be measured by Dual Energy X-ray Absorptiometry (DXA) technology, on femoral and lumbar spine (L2-L4) sites.
~Recruitment of healthy volunteers through registers (Clinical Investigation Centers) and advertisements."
15807946|NCT04384341|Biological|Blood sampling for patients only|For patients, fVIII/fIX activity and antigen, thrombin generation potential and plasmatic markers of bone remodelling will be measured centrally.
15807947|NCT04384328|Other|Early Support Programme in Orthophony|Early support in speech therapy lasts between 6 months and 24 months of corrected age. It includes 10 to 20 sessions depending on the child's needs. These sessions are conducted by a speech-language pathologist from the RPSOF-ASNR network, trained in the issues specific to the very premature child and the network's tools.
15807948|NCT04384315|Other|Questionnaires|Questionnaires to assess the quality of life (EQ-5D, CVVQ, CIVIQ, AVVQ, Patient satisfaction survey)
15807949|NCT04384302|Other|Visual training|Pre-defined visual training protocol including the optometrical unit exercises
15807950|NCT04384289|Procedure|Nursing care based on the Transitonal Care Model|Nursing care carried out in collaboration with a multidisciplinary team in line with Transitonal Care Model for elderly patients who have undergone open heart surgery
15807953|NCT04384263|Behavioral|Tai Chi|Participants in the Tai Chi group will practice a Yang style, 8-form Tai Chi routine. Specifically, the routine will incorporate slow, deep breathing and mental relaxation by utilizing Tai Chi movements which: 1) are slow and smooth; 2) without break or pause; and 3) have minimal muscular force and exertion. In addition, investigators will emphasize the breathing techniques of Tai Chi exercise. Investigators will adopt methods of progression to enable the participants learn and safely adapt to the Tai Chi routine and improve skills of practicing, specifically: 1) Tai Chi forms will be taught one at a time; 2) participants will receive instructional videos with step-by-step instructions of how to perform the new Tai Chi form that has been taught in the live online Tai Chi exercise session. Participants will be encouraged to practice Tai Chi offline between live online Tai Chi exercise sessions; however, no time requirement will be proposed.
15807954|NCT04384250|Diagnostic Test|Whole Exome Sequencing|Genetic study of patients
15807955|NCT04384237|Procedure|Er,Cr:YSGG laser-aided CSF|After injection 2% lidocaine with 1:80.000 epinephrine concentration in labial and lingual vestibule the fiberotomy is carried out by inserting a 9 x 0.5 mm laser tip into the gingival sulcus with an angle of 10-15º to the radicular surface
15807956|NCT04384237|Procedure|Conventional CSF|After injection 2% lidocaine with 1:80.000 epinephrine concentration in labial and lingual vestibule the fiberotomy is carried out by inserting a surgical blade (#11)into the gingival sulcus at an angle of 10-15º to the radicular surface
15807957|NCT04384224|Other|acupuncture|use disposable sterile steel needles to insert to the acupuncture point
15807958|NCT04384211|Other|Computer Assisted Detection Software For Vertebral Fractures|A device named Smart Bone that is using CT image retrospectively acquired to entails a second review of CT images with Vertebral Compression Fractures through an interactive AI program developed by Quanta Computer Inc. was applied to the CT images. The device is a computer-aided detection (CADe) software application and is designed to assist radiologists to analyze Spine CT images. The device uses deep learning methods to perform vertebrae detection and classification of images.
15807959|NCT04384198|Procedure|Sonolysis|Continuous transcranial Doppler sonography (TCD) using a 2-MHz diagnostic probe with maximal diagnostic energy
15807960|NCT04384185|Other|Exercise protocol|"Exercises:
~Pelvic tilt.
~brinding.
~cuadruped arm/leg raise.
~Abdominal strengthening exercises.
~Low-back muscles stretching.
~The side bridge.
~Side leg separation"
15807961|NCT04384185|Other|Manual therapy|"Functional diaphragm balancing technique: gentle vertical pressure was applied for 5 minutes at the diaphragm level.
~Muscle fiber stretching technique: a cranial traction was performed from the lower edge of the costal arches during the inspiratory breathing phase, for more than 10 respiratory cycles.
~Phrenic-center inhibition technique (Figure 3C): the soft tissue was pumped during the expiratory phase by gently and simultaneously using both hands to create pressure in cranial and caudal direction, for more than 10 respiratory cycles."
15807962|NCT04384172|Device|Tibial e-stim|For tibial nerve stimulation, the two electrodes will be placed just above the medial malleolus and the ipsilateral calcaneus on one leg near the ankle.
15807963|NCT04384172|Device|Genital e-stim|For dorsal genital nerve stimulation, two electrodes will be placed on either side of the clitoris.
15807964|NCT04384146|Radiation|Cyclical Hypofractionated Palliative Radiation (Quad Shot)|3.7 Gy twice daily x 2 days for a total dose of 14.8 Gy per cycle. The next cycle will occur after a 21-28 day break.
15807965|NCT04384146|Behavioral|EORTC QLQ-C30 questionnaire|at baseline, each cycle of Quad Shot, and at 3 weeks, 3 months and 6 months after last cycle of Quad Shot.
15807966|NCT04384133|Diagnostic Test|Impulse oscillometry|Impulse oscillometry is a pulmonary function test. During the test, the participant is told to breathe normally.
15807967|NCT04384133|Diagnostic Test|Spirometric pulmonary function test|In the spirometric pulmonary function test, the participant is asked to perform respiratory maneuvers such as breathing deeply.
15807970|NCT04384133|Diagnostic Test|Chest X Ray|Chest X ray is a radiological examination.
15807971|NCT04384133|Diagnostic Test|Blood eosinophil level|A tube of blood will be drawn from the participant.
15807972|NCT04384133|Other|CAT|It consists of 8 questions.
15807973|NCT04384133|Other|mMRC|It is the scale used to measure the severity of shortness of breath.
15807974|NCT04384120|Device|Blood Flow Restriction Therapy|Blood flow restriction cuffs which are FDA approved will be provided to patients randomized into the BFR group. Patients will be provided video instruction and training on how to conduct the traditional therapy exercises with the use of BFR.
15807975|NCT04384120|Procedure|Traditional Therapy|Patients will be provided video instruction and training on how to conduct the traditional therapy exercises.
15807976|NCT04384107|Biological|V114|Subcutaneous 0.5 mL single dose
15807977|NCT04384107|Biological|PCV13|Subcutaneous 0.5 mL single dose
15807978|NCT04384094|Device|Esthesiometer measurement|Measuring the corneal sensitivity using rebound technology.
15807979|NCT04384081|Drug|BI 456906|Solution for injection
15807980|NCT04384081|Drug|Placebo|Solution for injection
15807981|NCT04384055|Diagnostic Test|Lung Ultrasound|Lung ultrasound will be performed on patients undergoing investigation for covid-19 based on a nasopharyngeal PCR.
15807982|NCT04384042|Other|Patient-Reported Online Questionnaire on Olfactory & Taste Disturbances|This is an online patient-reported questionnaire that examines the presence or absence of olfactory and taste disturbances, the onset of olfactory and taste disturbances in relation to other COVID-19 symptoms, and the temporal evolution of the severity of olfactory and taste disturbances. The occurrence of ear symptoms in COVID-19 infection will also be evaluated in this questionnaire as a secondary outcome. The questionnaire will also have questions relating to the patient's underlying health conditions, risk factors for COVID-19 infection, and demographics.
15807984|NCT04384016|Biological|Skyvaricella Injection|"The main target is evaluating the safety of SKYVaricella injection in healthy Vietnamese children from 12 months to 12 years, with a single injection.
~The secondary target is to Assess the immunogenicity of SKYVaricella inj. in a small group of healthy Vietnamese children from 12 months to 12 years, with a single injection."
15807985|NCT04384003|Device|Shear Wave Ultrasound Elastography|"Scanned protocols of sonographic imaging will be used in this study to measure extrinsic (FDL, FHL and PER) and intrinsic (AbdH, FDB and FHB) muscle CSA and thickness, and plantar fascia thickness (at heel, mid and forefoot sites).
~The muscle stiffness will be calculated from the program provided by the US machine as shown real time elastography (RTE, unit: KPa)."
15807986|NCT04384003|Device|The 3-D Motion Analysis|The 3-D Motion Analysis, Forceplates and EMG acquisition system and full body kinematic model (Bonita, VICON Corp, UK) in the Biomechanics and Motor Control Laboratory (BMCL).
15807987|NCT04384003|Device|Electromyographic|Electromyographic activity (EMG) of AbdH, TA, PL, SO, gluteus medius (Glut Med) and gluteus maximus (Glut Max) will be recorded bilaterally using pairs of surface electrodes. Motor coordination of these muscles will be evaluated through assessment of temporal and spatial parameters of EMG during functional tasks such as kicking in one leg standing. The primary outcome measure will be percentage of EMG relative to maximal voluntary contraction (MVC) on the same side. In order to remove the potential for investigator bias, all data will be presented individually without identification of the muscle, order of trials or whether the trials precede or follow the intervention.
15807988|NCT04384003|Diagnostic Test|Foot intrinsic muscle assessment and training device|The main concept for this design is to provide the quantitative assessment of the foot intrinsic muscles and facilitation of intrinsic muscles of the fool during functional sporting activities such single-leg-standing.
15807989|NCT04383990|Other|Timing of taking insulin|To take insulin Glargine early (6-7pm) or late (bedtime-10-12pm)
15807990|NCT04383977|Drug|Apatinib and Etoposide capsule|Apatinib (375 mg qd, q3w) and Etoposide capsule(50 mg/d, d1-14, q3w) combination until disease progression or intolerable toxicity
15807991|NCT04383977|Drug|Apatinib|Apatinib (375 mg qd, q3w) until disease progression or intolerable toxicity
15807992|NCT04383964|Device|Distraction Osteogenesis for Reconstruction of Ramus-Condyle|transport distraction osteogenesis in restoring the deficient condyle/ramus unit of patients with TMJ ankylosis to correct the resultant deformity either unilaterally or bilaterally.
15807993|NCT04383951|Other|Dietary consult for participants in the ketogenic diet arm|An initial consultation with the providers of medically supervised weight loss clinic will be arranged. Participants in the ketogenic diet group will be educated on the concepts of the diet and will be provided with recipes to be utilized at home that adhere to this diet. In addition to the initial consultation, participants in this arm receive additional consultations with these providers with a frequency as determined by the provider.
15807994|NCT04383951|Other|Dietary consult for participants in the standard of care arm|For participants in the standard of care arm, an initial consultation with the providers of medically supervised weight loss clinic will be arranged and the discussion will center around portion control using a balanced diet. Participants will receive only one additional consultation with the provider 16 weeks later just prior to the conclusion of the study.
15807995|NCT04383938|Drug|APR-246 (eprenetapopt) + Pembrolizumab|APR-246 D1-4 + Pembrolizumab D3
15807996|NCT04383925|Biological|BCG-Japan|Infant (<1 year) 0.05 ml dose of resuspended BCG-Japan (Tokyo strain 172, Japan BCG Laboratory, 1-5-21 Otsuka, Bunkyo-ku, Tokyo, 112-0012 Japan).
15807997|NCT04383925|Biological|BCG-Russia|Infant (<1 year) 0.05 ml dose of resuspended BCG-Russia (Serum Institute of India)
15807998|NCT04383912|Drug|Botox Injectable Product|The side randomized to receive treatment will be injected with onabotulinum toxin A. Wound healing, scar characteristics, and patient satisfaction will be assessed post operatively. Scarring will be assessed by the patient, medical observers and a lay observer, all masked to the treatment vs placebo side. Standardized scales will be used, and pre-operative, intra-operative, and post-operative photographs will be taken for all participants. ImageJ software will be used to analyze the photos and measure the degree of brow lift achieved on each side, to ensure this has not been affected by onabotulinum toxin injection.
15807999|NCT04383912|Other|No intervention (placebo)|This group (of brows) will be receiving placebo injections containing normal saline. They will be assessed in the same manner as the treatment side.
15808035|NCT04383665|Device|STN DBS 10Hz|Stimulation of existing DBS device at 100Hz, with other parameters at baseline
15808000|NCT04383899|Other|Questionnaire|All patients testing positively for COVID-19, with completed questionnaires. As appropriate, the duration of the study will be at least the time to complete the questionnaire for non-hospitalized patients, and for those who are hospitalized, they will be followed until hospital discharge or death to ascertain outcome.
15808001|NCT04383886|Other|stress and anxiety questionnaire|Emergency department staff will be asked to fill in questionnaires in order to measure their stress and anxiety level, their propensity to have a burn-out, their consumption of psychoactive substances such as alcohol, tobacco, coffee or anxiolytic, their sleep disorder.
15808002|NCT04383873|Device|Training by means of Armeo Spring device|This patients group receive 40 experimental sessions. Each session is based on 30 min by using Armeo Spring device.
15808003|NCT04383873|Other|Current treatment based on conventional therapy|All the patients enrollment in the study receive 30 min of conventional therapy during 40 sessions.
15808004|NCT04383873|Other|Additional treatment based on conventional therapy|This intevention was added for providing the same amount of therapy than those patients randomly enrolled in the intervention group. So, patients in the control group receive other 30 min of conventional therapy added on current treatment during 40 sessions.
15808005|NCT04383860|Procedure|5-0 suture|5-0 suture administration during surgery
15808006|NCT04383860|Procedure|4-0 suture|4-0 suture administration during surgery
15808007|NCT04383847|Behavioral|Sumadhur Aarambha|Group intervention for newly married women, their husbands, and mothers-in-law with information mainly about nutrition, but also pre-pregnancy health, reproductive/pregnancy health and gender equality.
15808008|NCT04383834|Device|NobelActive® TiUltra™ implants and On1™ Base/Xeal™ along with On1 components|"The NobelActive® TiUltra™ implant is an ultra-hydrophilic multi-zone anodized implant surface. NobelActive® TiUltra™ features a gradual change in topography, from a minimally rough non-porous nanostructured implant collar to a moderately rough porous apex: more than roughness. NobelActive® TiUltra™ collar features surface chemistry and topography that promote early osseointegration and are designed to support bone stability. In addition, the Protective Layer preserves the pristine surface chemistry and hydrophilicity.
~The second new product is the Base/Xeal™ new surface, which is covered by a titanium oxide layer, created by electrochemical anodization of a titanium machined component, resulting in a yellow hue nano-structured surface."
15808009|NCT04383821|Device|Double-Trunk Mask|The DTM (oxygen delivery system) is worn by the patient for 30 minutes.
15808010|NCT04383821|Device|Non-Rebreather mask|The NRM (standard oxygen delivery system) is worn by the patient for 30 minutes.
15808011|NCT04383808|Diagnostic Test|Injected radiotracer with PET Insert|"Informed consent will be obtained before beginning any study procedures.
~Participants will receive a small quantity of an FDA approved radiotracer. The PET insert is placed within a 3T MRI scanner, where PET and MRI imaging will be completed."
15808012|NCT04383808|Diagnostic Test|Pre-injected group with PET insert|"Informed consent will be obtained before beginning any study procedures.
~Participants who have received radiotracer for another PET imaging system. The PET insert is placed within a 3T MRI scanner, where PET and MRI imaging will be completed."
15808013|NCT04383795|Drug|Antithyroid Drug|Administration of antithyroid Drug for 6 months
15808014|NCT04383782|Behavioral|Expectancy Challenge|Expectancy challenge intervention (see description in study arms).
15808015|NCT04383782|Behavioral|Expectancy Challenge + Behavioral Activation|Expectancy challenge + behavioral activation interventions (see description in study arms)
15808016|NCT04383782|Behavioral|Control|Neutral reading condition (see description in study arms).
15808017|NCT04383769|Other|questionnaires survey|data will be collected from the medical records already existed in the hospital and community-based organization (CBO) systems and entered into case report form (CRF). The expected number of participants is 5000. For each participant, the data will be collected prospectively for 24 months and retrospectively up to 5 years from the screening date. This study has no intervention and will not alter ART services whether be standard or DSD-ART at hospitals.
15808018|NCT04383756|Biological|Donor Blood|Up to 4 units (each unit contains 350mL) of leukoreduced donor whole blood
15808019|NCT04383756|Biological|Banked Blood|Up to 350mL of Allogenic banked component blood transfusion in a 1:1:1 manner (packed red blood cells : plasma : platelets)
15808020|NCT04383743|Drug|Cisplatin|Given IV
15808021|NCT04383743|Drug|Doxorubicin|Given IV
15808022|NCT04383743|Drug|Methotrexate|Given IV
15808023|NCT04383743|Biological|Pegfilgrastim|Given SC
15808024|NCT04383743|Biological|Pembrolizumab|Given IV
15808025|NCT04383743|Procedure|Radical Cystectomy|Undergo standard of care radical cystectomy
15808026|NCT04383743|Drug|Vinblastine Sulfate|Given IV
15808027|NCT04383730|Drug|Intravenous sedation|Patients will be included retrospectively in the study by local investigators at each participating center. As this is a non-interventional study, sedation practices will be those currently used as standard practices in participating centers, including both intravenous and inhaled sedation practices
15808028|NCT04383730|Drug|Inhaled sedation|Patients will be included retrospectively in the study by local investigators at each participating center. As this is a non-interventional study, sedation practices will be those currently used as standard practices in participating centers, including both intravenous and inhaled sedation practices
15808029|NCT04383717|Drug|Levamisole and isoprinosine|oral tablets levamisole 50 mg 3 times daily every other day for 2 weeks Isoprinosine oral tablets 1 g 4 times daily for 2 weeks
15808030|NCT04383717|Drug|Azithromycin and hydroxychloroquine|oral tablets daily 500 mg azithromycin Oral tablets daily 200 mg hydroxychloroquine twice daily
15808031|NCT04383704|Other|New Dietary pattern ( Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND))|A new brain-protection pattern that has been designed after the Mediterranean and DASH diet to improve some of their dietary factors to have the highest impact on brain health and cognitive performance.
15808032|NCT04383691|Drug|Lurasidone HCl|Subjects will be administered orally, once daily, in the evening. Subjects will be treated with Lurasidone 20 mg/day for Days 1-2-3, 40 mg/day for Days 4-5-6, and 60 mg/day on Day 7. Flexible dosing of study drug will be permitted beginning on Day 8.
15808033|NCT04383691|Drug|Placebo|Subjects will be administered orally, once daily, in the evening. Subjects will be treated with Placebo.
15808034|NCT04383678|Device|Extracorporeal membrane oxygenation|Veno-venous or veno-arterial extracorporeal oxygenation
15808036|NCT04383665|Device|STN DBS 130Hz|Stimulation of existing DBS device at 130Hz, with other parameters at baseline
15808037|NCT04383665|Device|STN DBS off|Existing DBS device turned off
15808038|NCT04383652|Other|Biological sample and clinical data collection|Plasma and serum will be collected at day 0, day 7, day 14, 1 month and 4 months post diagnosis. Clinical data related to COVID-19 diagnosis, symptoms, and outcomes will be collected.
15808039|NCT04383639|Other|No product (A)/mixture of coca and carob together with breakfast (B)/mixture of coca and carob 10 h before breakfast (C)|The subjects will receive, after overnight fasting, a high-fat high-sugar breakfast. In treatment A, they will not receive any additional product; in treatment B, they will receive at the same time a mixture of coca and carob; in treatment C, they will receive the mixture of coca and carob 10 h before breakfast. A total of 6 blood samples will be collected during each visit: 0-30-60-120-180-240-270 min. Urine samples will be collected during the permanence of the subjects in the Unit of Human Nutrition. Feces will be collected the first time they are generated after treatments A and C. Both interventions will be separated by two weeks. Subjects will be instructed not to modify their dietary habits during the development of the study, but during the 72 h before each visit they will have to restrict the intake of polyphenol-rich foods (a detailed list will be provided).
15808040|NCT04383613|Other|Prone positioning|The intervention is prone positioning (i.e., instructing a patient to lie on their stomach while they are in bed) for 7 days or until the first of study hospital discharge or not requiring supplemental oxygen for >24 hours or study outcome. Patients will be asked to aim for prone positioning four times per day for at least two hours each time, and will be encouraged to sleep on their stomach at night.
15808041|NCT04383600|Procedure|Micro-osteoperforation|three flapless micro-osteoperforations was performed distal to the maxillary canine before starting retraction.
15808042|NCT04383587|Other|Serologic testing|COVID19 IgG antibody testing to be performed
15808043|NCT04383574|Biological|Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28|The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research & Development Co., Ltd..Two doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,28,and one dose of booster immunization with medium dosage (600SU/0.5ml) experimental vaccine 1 year after primary immunization at the schedule of day 0,28 in phaseⅠand 6 months after primary immunization at the schedule of day 0,28 in phase Ⅱ.
15808044|NCT04383574|Biological|Two doses of high dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28|The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research & Development Co., Ltd..Two doses of high dosage (1200SU/0.5ml) experimental vaccine at the schedule of day 0,28,and one dose of booster immunization with medium dosage (1200SU/0.5ml) experimental vaccine 1 year after primary immunization at the schedule of day 0,28 in phaseⅠand 6 months after primary immunization at the schedule of day 0,28 in phase Ⅱ.
15808045|NCT04383574|Biological|Two doses of placebo at the schedule of day 0,28|The placebo was manufactured by Sinovac Research & Development Co., Ltd., Two doses of placebo at the schedule of day 0,28,and one dose of booster immunization with placebo 1 year after primary immunization at the schedule of day 0,28 in phaseⅠand 6 months after primary immunization at the schedule of day 0,28 in phase Ⅱ.
15808046|NCT04383574|Biological|Two doses of low dosage inactivated SARS-CoV-2 vaccine at the schedule of day 0,28|The inactivated SARS-CoV-2 vaccine was manufactured by Sinovac Research & Development Co., Ltd..Two doses of low dosage (300SU/0.5ml)experimental vaccine at the schedule of day 0,28,and one dose of booster immunization with low dosage (300SU/0.5ml) experimental vaccine 6 months after primary immunization at the schedule of day 0,28 in phase Ⅱ.
15808047|NCT04383561|Other|Non-surgical periodontal treatment|Scaling and root planing (SRP), in four clinical visits
15808048|NCT04383561|Other|Oral hygiene instructions|Oral hygiene instructions includes brushing with the modified Bass technique, interdental cleaning with dental floss and interdental brushes.
15808049|NCT04383548|Other|hyper immunoglobulins containing anti-Corona VS2 immunoglobulin|Prospective randomized clinical study for efficacy of anti-SARS-CoV-2 hyper immunoglobulins prepared from COVID19 convalescent plasma using VIPS Mini-Pool IVIG medical device
15808050|NCT04383535|Other|Convalescent SARS COVID-19 plasma|Convalescent SARS COVID-19 plasma from a pool of 10 donor plasma. The calculation of the volume to be transfused will be from 10 to 15 ml / kg adjusting the volume to the body weight of each patient, at a suggested infusion rate of 5 to 10 ml / kg / h with an intravenous infusion pump. The infusion rate will be adjusted according to the clinical stability of the patient according to the treating physician.
15808051|NCT04383535|Other|Placebo|Single infusion of saline solution, in addition to standard care. The calculation of the volume to be transfused will be from 10 to 15 ml / kg adjusting the volume to the body weight of each patient, at a suggested infusion rate of 5 to 10 ml / kg / h with an intravenous infusion pump. The infusion rate will be adjusted according to the clinical stability of the patient according to the treating physician.
15808052|NCT04383509|Behavioral|Cognitive Control Training|Cognitive Control Training (CCT) makes use of a very basic cognitive task that strongly loads on working memory and cognitive control processes, namely the adaptive Paced Auditory Serial Addition Task (aPASAT) where participants are given a number every 3 seconds and are asked to add the number they just heard with the number they heard before. Task difficulty is modified based on the participants current task performance, allowing training of cognitive control. Participants in the intervention group will start the CCT training after completion of ECT with a maximum time interval of 7 days. Training sessions will be performed on a tablet or computer and participants will complete five sessions per week (20 minutes per session) for a period of two weeks.
15808053|NCT04383509|Behavioral|Active Control|Participants in the active control group will start placebo training after completion of ECT with a maximum time interval of 7 days. The placebo task consists of a task similar to the experimental condition but that does not train cognitive control. Prior research confirmed that this condition controls for non-specific effects of the training and motivational issues. Participants will perform the sessions on a tablet or computer and complete five sessions per week (20 minutes per session) for a period of two weeks.
15808054|NCT04383496|Behavioral|Physical Activity|In-person, virtual conferencing, and telephone sessions, wearable device for daily feedback and motivation
15808055|NCT04383483|Other|COVICU|COVICU
15808255|NCT04381767|Device|EYE-SYNC|Evaluation of oculomotor performance using visual presentation and eye tracking analysis
15808260|NCT04381702|Procedure|Pancreatoduodenectomy|Open or laparoscopic pancreato-duodenectomy with pancreatojejunal anastomosis
15808056|NCT04383457|Device|RIA-device (Remote Investigation and Assessment)|The investigated new system consists of a high-speed digital video camera, a digital radiometric infrared camera, LED lights and a computer for data recording. This system faces the subject at a distance of approximately one meter, capturing a 30 second recording of the subject's face.
15808057|NCT04383431|Procedure|PACK-CXL|Standard epithelium-off CXL, 12 minutes soaking time with riboflavin, 8 minutes UVA corneal irradiation pulsed mode.
15808058|NCT04383418|Drug|dexmedetomidine nasal spray|dexmedetomidine nasal spray
15808059|NCT04383418|Drug|dexmedetomidine hydrochloride nasal spray blank preparation|dexmedetomidine hydrochloride nasal spray blank preparation
15808060|NCT04383405|Other|Aquatic Training|Aquatic Training training consists of a sequential and a preparatory approach aimed at enhancing dynamic postural stability. The exercises follow a specific sequence starting from a kneeling position, proceeding to a sitting position and ending with a supine position. Step exercises preparatory for gait were performed using a step and two floating aids. Gait exercises were performed first with the upper limbs placed on two floating aids and then during a dual motor task (i.e. catching a ball thrown by the therapist). Subjects performed three sessions a week for four weeks and each session lasting 45 minutes. The training was carried out by a physiotherapist who had at least 5 years of experience in aquatic neurorehabilitation.
15808061|NCT04383405|Other|Conventional Training|Conventional land-based therapy consists of customized exercises focused on static and dynamic postural stability improvement. The exercises included the active-assisted mobilization, the muscle stretching the postural transition, the balance and the gait training. The control approach was carried out three times a week for four weeks and each session lasted 45 minutes.
15808062|NCT04383392|Device|Rate adaptive pacing|Rate-adaptive pacing is a function of permanent pacemaker to accelerate patients' heart rate when they are walking, stair climbing, running or carrying on intensive physical activity. Appropriately, the function is similar to human's electrophysiology of sinus node but it may be difficult to replace sinus node's function totally. For example, the acceleration or deceleration slope when exercise beginning or cessation is not always the same or consistent in different patients and different time.
15808063|NCT04383379|Behavioral|Experimental: Intervention group|The intervention NICUs (n = 6) will receive training in the Evidence-based Practice for Improving Quality (EPIQ) method and then develop, implement, and document evidence-based practice changes toimprove the rate of breastfeeding . Compliance with practice changes and neonatal outcomes will be monitored. NICUs will receive quarterly feedback on their progress, as well as access to implementation support.
15808064|NCT04383366|Device|Pentacam® (Oculus, Inc., Wetzlar, Germany)|Scheimpflug imaging
15808065|NCT04383366|Device|Casia II (Tomey Germany, Nürnberg)|Anterior segment optical coherence tomography
15808066|NCT04383366|Device|Spectralis Anterion (Heidelberg Engineering, Heidelberg, Germany)|Anterior segment optical coherence tomography
15808067|NCT04383340|Behavioral|Mother-Infant Transaction Program|Parent sensitivity training for mothers of premature infants
15808068|NCT04383340|Behavioral|Treatment as usual|Standard hospital care and parental support
15808069|NCT04383327|Behavioral|ParentCorps-Professional Development (PD)|Multi-component school-based intervention that promotes early childhood mental health and development. Teachers and PTAs (pre-primary to 4th grade) will participate in a 3-day ParentCorps-PD training before the 1st school term. They will also receive 8 sessions (12 hours) of face-to-face group-based coaching during the 1st and 2nd terms. Coaching sessions are to help teachers apply EBI strategies in their classrooms, engage families, and develop competencies.
15808070|NCT04383327|Behavioral|T-Wellness|A brief teacher stress management psychoeducation package, adapted from EBIs including a half-day workshop for common stress management and a half-day for burnout management, and three follow-up group support sessions (3 additional monthly 1-hr wellness sessions for teachers as a group in each school, a total 15 hours of coaching).
15808071|NCT04383314|Behavioral|10-week exercise program on HA accumulation|A 10-week exercise program with both aerobic and resistance components, based on the American College of Sports Medicine (2010), will be individually prescribed to 25 T2DM patients.Exercise training will be performed on Days 1 and 2 of each week under the supervision of licensed physical therapists. Participants will have the choice of using a treadmill or a recumbent stepper. The physical therapists will monitor blood glucose level, blood pressure, heart rate, and RPE during each exercise session. Participants will be asked to exercise at home on Day 3 of each week, and will not be supervised by the study team.
15808072|NCT04383301|Procedure|Intracorneal ring segment implantaion as the first stage|Intracorneal ring segment (ICRS)
15808073|NCT04383301|Procedure|ACXL and wafe front guieded TPRK as the second stage|Accelerated corneal cross linking (ACXL) and wafe front guided transepithelial photorefractive keratotomy (TPRK)
15808074|NCT04383275|Drug|capecitabine and trastuzumab|In IRIS-A cohort, patients who met the inclusion criteria(ER，PR<10%, T≤2cm or ER,PR ≥10% 1cm<T≤2cm）would be given capecitabine for 6 cycles with standard trastuzumab for 1 year, in which HR+ patients would be given endocrine therapy for 5 years.
15808075|NCT04383275|Drug|endocrine therapy and trastuzumab|In IRIS-B cohort, patients who met the inclusion criteria(ER,PR ≥10% T≤1cm) would be given endocrine therapy (premenopausal: tamoxifen or toremifene; postmenopausal: letrozole or anastrozole or exemestane) combined with standard trastuzumab for 1 year and complete endocrine therapy for 5 years.
15808076|NCT04383262|Drug|Lexiva|A repurposing approach, prospective, placebo-controlled clinical trial of Lexiva (used at the FDA approved, manufacturers recommended dose for HIV (1,400mg twice daily) for 12 weeks in medically refractory patients with clinically diagnosed moderate/severe LPR (RSI ≥ 20, RFS ≥ 11 and MII-pH confirmed laryngeal reflux events).
15808077|NCT04383249|Diagnostic Test|Pathology result|Pathology result of the hernia sac
15808078|NCT04383236|Other|Probiotics|Sixty adult (group A) and 60 children patients (group B) with diagnosis of minor RAS were included. Both groups were divided into two subgroups, AI and BI (test subgroups) and AII and BII (control subgroups). For test subgroups, probiotic lozenges were consecutively administered twice daily, for five days. The size and pain level of ulcers were recorded on treatment days 0, 3 and 5. The outbreak frequency of RAS within 6 months was investigated for all subgroups.
15808256|NCT04381754|Device|Passeo-18 Lux|Patients with significant inflow or outflow stenosis between the anastomosis to the axillary-subclavian vein junction, as defined by the insertion of the cephalic vein, who had undergone fistuloplasty with Passeo-18 Lux
15808079|NCT04383236|Drug|Oracure oral gel|Sixty adult (group A) and 60 children patients (group B) with diagnosis of minor RAS were included. Both groups were divided into two subgroups, AI and BI (test subgroups) and AII and BII (control subgroups). For control subgroups, oracure gel were consecutively applied twice daily, for five days. The size and pain level of ulcers were recorded on treatment days 0, 3 and 5. The outbreak frequency of RAS within 6 months was investigated for all subgroups.
15808080|NCT04383223|Behavioral|iTransition|Is a mobile website application (app), and it can be used on a range of devices (computer, tablet, smartphone) and operating systems (iOS, Android, Windows). Features of iTransition will include, but are not limited to: medication reminders, calendar tracking of appointments, direct messaging between youth and providers, and privacy password lock.
15808082|NCT04383197|Behavioral|Endurance exercise training|Ergometer cycling at 70 % of VO2 max, 45 minutes, 3 times a week
15808083|NCT04383197|Drug|Semaglutide|3 months of therapeutic treatment with semaglutide
15808084|NCT04383184|Procedure|tracheoplasty|tracheoplasty and only left pulmonary artery transplantation
15808085|NCT04383171|Device|Motomed cycle ergometer (MOTOmed letto2 - Reck, Reckstr 1-5, Betzenweiler 88422, Germany).|
15808086|NCT04383158|Other|PRGF ENDORET® obtained from ENDORET® POST-EXTRACTION ALVEOLUS DENTAL KIT (KMU16)|ENDORET® POST-EXTRACTION ALVEOLUS DENTAL KIT (KMU16) is a system for obtaining plasma rich in growth factors (PRGF), which can be applied in the regeneration of bone and other connective tissues in oral surgery. PRGF is a completely autologous blood platelet concentrate that stimulates tissue regeneration due to enrichment with autologous growth factors, acting as a biological system.
15808087|NCT04383145|Device|endovascular repair|Endovascular repair of thoracoabdominal aneurysm using stent grafts.
15808088|NCT04383132|Device|Abdominal Binder|abdominal binder is a kind of elastic abdominal compression device
15808089|NCT04383119|Drug|Trabectedin|Trabectedin in monotherapy
15808090|NCT04383119|Drug|Gemcitabine|Gemcitabine, control arm
15808091|NCT04383119|Drug|No Intervention: Observational Cohort|Treatment according clinical practice
15808092|NCT04383106|Other|no intervention|no intervention
15808093|NCT04383093|Drug|Tadalafil 5mg|Combination therapy of daily tadalafil plus tamsulosin
15808094|NCT04383080|Procedure|Acupuncture|acupuncture at specific acupuncture points
15808095|NCT04383080|Device|Low-level laser therapy|low level laser emission on specific acupuncture points
15808096|NCT04383067|Procedure|Tumor Infiltrating Lymphocytes (TIL)|Patient with metastatic urothelial carcinoma will undergo a autologous lymphocyte transplantation. Patient will undergo surgery to remove either the primary tumor or a tumor metastasis. The cells collected in this surgey will be cultured and reintroduced to the patient. Following the cell infusion, patient will receive a high-dose bolus of IL-2.
15808097|NCT04383067|Drug|Proleukin|high-dose (720,000 IU/kg) IL-2 will be administered every 8 hours, to tolerance. A maximum of 10 doses will be administered
15808098|NCT04383054|Behavioral|'More minutes' conversation (Moving medicine)|For the interventions in this study we have chosen to use the Moving Medicine conversation tools because they are an evidence-based PA intervention tool. The Moving Medicine 'more minutes' conversation tool initially involves the investigator exploring the participant's understanding of PA. Improving patients' knowledge of the benefits of PA may empower them to increase their PAL because knowledge of the benefits of PA may motivate patients to increase their PAL. The division of the Moving Medicine conversation tools into chronic health conditions is important because it will allow the investigator to explore topics relating to PA which are specific to the participant's own medical co-morbidities. For example, in a patient with known ischaemic heart disease the investigator could discuss how PA helps to prevent the risk of further heart attacks and the development of heart failure (Moving Medicine).
15808099|NCT04383054|Behavioral|'one minute' conversation (Moving medicine)|For the interventions in this study we have chosen to use the Moving Medicine conversation tools because they are an evidence-based PA intervention tool. The Moving Medicine 'more minutes' conversation tool initially involves the investigator exploring the participant's understanding of PA. Improving patients' knowledge of the benefits of PA may empower them to increase their PAL because knowledge of the benefits of PA may motivate patients to increase their PAL. The division of the Moving Medicine conversation tools into chronic health conditions is important because it will allow the investigator to explore topics relating to PA which are specific to the participant's own medical co-morbidities. For example, in a patient with known ischaemic heart disease the investigator could discuss how PA helps to prevent the risk of further heart attacks and the development of heart failure (Moving Medicine).
15808100|NCT04383041|Other|No intervention|Completing questionnaires via ePRO app from their own mobile devices
15808101|NCT04383028|Procedure|MELD algorithm use to aid in the planning of SEEG electrode trajectories|"During the routine SEEG planning meetings, the planning of SEEG trajectories, including the number and location of electrodes, will follow the usual clinical pathway and be planned according to the expertise of the attending neurosurgeon, neurophysiologist and neurologist at the multidisciplinary team meeting. Once the trajectories have been planned, anonymised scans for each patient (linked to them via a unique study ID) will be run through the MELD classifier and the top 3 MELD identified lesion clusters will be considered for further implantation.
~These top 3 MELD classifier identified clusters will then be merged with the existing clinical plan to assess if each of the clusters are already being sampled by an SEEG electrode. If there is already an electrode in each lesion, no adjustments will be made. If there are clusters that are not being recorded from, and it is technically possible, extra electrodes (up to 3) will be added to record from these additional locations."
15808102|NCT04383015|Other|Exercise strategies|Strategies for exercise in type 1 diabetes to maintain glucose control
15808103|NCT04383002|Drug|Nitric Oxide|iNO will be given at 160ppm for 6 hours, once a day, for 2 days
15808104|NCT04382989|Device|Analysis of human milk composition by mid-infrared spectrophotometry|"Analysis of human milk macronutrient content was performed by mid-infrared spectrophotometry using a Miris Human Milk Analyser.
~An immune-enzymatic ELISA assays were used to estimate lysozyme and lactoferrin concentrations in human milk."
15808257|NCT04381741|Biological|CD19-7×19 CAR-T plus PD1 monoclonal antibody|Three different doses of CD19-7×19 CAR-T (1×106/kg、2×106/kg、3×106/kg) plus 200mg Tislelizumab every 3 weeks for 6 times
15808261|NCT04381689|Biological|IL-YANG FLU Vaccine Prefilled Syringe INJ.|Teratect Prefilled Syringe Inj. 0.5mL
15808105|NCT04382963|Other|High Risk - intensive coaching|"The following assessment will occur: health assessment, blood pressure, BMI, history TIA/stroke, blood mRNA and protein analysis, ultrasound, cognitive assessment, stroke education, intensive coaching face-to-face.
~Furthermore, this group will receive intensive initiation of the American Heart Association Guidelines for Management of Risk Factors with individual face-to-face coaching meetings on lifestyle change and adherence to treatment on at a least quarterly basis."
15808106|NCT04382963|Other|High Risk - standard care|The following assessment will occur: health assessment, blood pressure, BMI, history TIA/stroke, blood mRNA and protein analysis, ultrasound, cognitive assessment, stroke education.
15808107|NCT04382963|Other|Low Risk - control|Control participants will undergo the same study events as the Low Risk group, except without receiving information and advice about eliminating stroke risk factors.
15808108|NCT04382950|Combination Product|Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP (rbACE2) plus Aerosolized 13 cis retinoic acid|In this study, the experimental group will receive 0.4 mg/kg rbACE2 IV plus Aerosolized 13 cis retinoic acid in gradual in 2 divided doses increases froms 0.2 mg/kg/day to 4 mg/kg/day as inhaled 13 cis retinoic acid therapy for 14 days
15808109|NCT04382937|Drug|P1101 + Ribavirin|P1101 400 µg SC Q2W + Ribavirin 800-1400 mg PO daily
15808110|NCT04382937|Drug|PEG-Intron + Ribavirin|PEG-Intron 1.5 µg per kg SC Q1W + Ribavirin 800-1400 mg PO daily
15808111|NCT04382924|Drug|NP-120 (Ifenprodil)|Ifenprodil, 20 mg TID Ifenprodil, 40 mg TID
15808112|NCT04382911|Drug|18F-fluoroestradiol|Patients will receive the FES tracer during a PET/MRI scan
15808115|NCT04382885|Drug|Cariprazine|Oral Solution
15808116|NCT04382859|Procedure|Transversus abdominis plane (TAP) block with liposomal bupivacaine|Transversus abdominis plane (TAP) blocks are safe and effective procedures for the provision of postoperative pain management following abdominal procedures (3) and have been widely used across specialties with reduction in postoperative pain and narcotic use (4-7).
15808117|NCT04382846|Drug|Nitazoxanide|Nitazoxanide
15808118|NCT04382833|Other|HOT APPLICATION|HOT APPLICATION
15808119|NCT04382833|Other|MASSAGE|
15808120|NCT04382807|Behavioral|Counseling|Online delivered group counseling session, providing insights into the tinnitus symptoms
15808121|NCT04382794|Drug|Retrospective case-control analysis|Evaluation of clinical, laboratory and instrumental parameters of diabetic patients during hospitalization for COVID-19. The data will be extracted anonymously from the computerized medical records commonly used in clinical practice by the centers involved in the study
15808122|NCT04382781|Drug|NO-Immunosuppressive|Patients not receiving immunosuppressive drugs
15808123|NCT04382781|Drug|Immunosuppressive|Patients receiving immunosuppressive drugs (overall, and specific drugs)
15808124|NCT04382781|Drug|Immunoglubulins|Patients receiving immunoglubulins
15808125|NCT04382768|Drug|Inhaled Hypertonic ibuprofen|Standard of care plus lipid ibuprofen 50mg tid
15808126|NCT04382755|Drug|Zilucoplan®|14 days of SC Zilucoplan® on top of standard of care + prophylactic antibiotics until 14 days after last Zilucoplan®
15808127|NCT04382755|Drug|Placebo|standard of care treatment + 1 week of prophylactic antibiotics + 1 week of prophylactic antibiotics (or until hospital discharge, whichever comes first)
15808128|NCT04382742|Behavioral|Dynamic Resistance Exercises|Modified Wingate protocol that incorprates 20 minutes of training on a cycle ergometer; included one minute of cycling with resistance to be performed at 85% to 90% of Maximal Heart Rate (MHR) followed by one minute of cycling with no resistance. The protocol will be performed for 10 times for a duration of 20 minute of workout.
15808129|NCT04382729|Other|Neuromuscular Electrical Stimulation|The intervention group, in addition to the daily routine physical therapy, receives NMES for 15 days (5 days per week for 3 weeks). NMES is applied bilaterally using an electrical stimulator with pairs of electrodes placed transversally on the quadriceps muscles and on the gastrocnemius muscles. The stimulation protocol consists in the application of symmetrical biphasic rectangular pulses with a frequency of 30 Hz (pulse duration: 400 µs). Stimulation intensity is adjusted daily by the physical therapist to elicit a visible twitch in each muscle. The total duration of the NMES session is 30 min for the first week and 45 min for the second and third week. Stimulation (on) time is 5 s and relaxation (off) time is 15 s, thus eliciting a total of 90 evoked contractions per day during the first week and 135 contractions per day during the second and third week.
15808130|NCT04382729|Other|Physical Therapy Exercise|The control group is subjected to a protocol of physical therapy exercises, applied once a day for 30 minutes (5 days per week for 3 weeks) by the staff physical therapists. It starts with global passive range of motion exercises, followed by active and resistive exercises (including controlled breathing exercises and respiratory muscle training), transfer to the edge of the bed or to a chair, standing and walking.
15808131|NCT04382716|Other|No intervention|No intervention; observation only
15808132|NCT04382703|Behavioral|Self-Affirmation Exercise|"The self affirming exercise is as follow:
~The beginning to a sentence appears below. Below it are 4 different ways of completing the sentence. On the lines provided, please write out the beginning of the sentence and then complete it with 1 of the 4 options we have given you.
~If I feel threatened or anxious, then I will …………………………………..
~Options are as follows:
~think about the things I value about myself, remember things that I have succeeded in, think about what I stand for or think about things that are important to me"
15808133|NCT04382703|Behavioral|Control|Given a questionnaire minus the self affirming exercise
15808134|NCT04382690|Behavioral|All participants will be asked to respond to the same survey questions|All participants will be asked to respond to the same survey questions
15808212|NCT04382014|Dietary Supplement|MAG fish oil + Curcumin OR Rice bran oil + Curcumin OR Curcumin extract|"The intervention is a randomized double blind cross over design testing the pharmacokinetics of 1) curcumin combined with MAG fish oil as a carrier, 2) curcumin combined with rice bran oil as a carrier, and 3) curcumin extract.
~Treatments are randomly assigned on days 1, 8 and 15 of the clinical study. Blood samples will be collected at time 0, 1, 2, 3, 4, 5, 6, 8, 10 and 24h after taking the supplement. Each participant will perform all three treatments, with a minimum of 7 days between treatments. A questionnaire will document the side effects felt by participants."
15808135|NCT04382677|Behavioral|Promoting First Relationships ®|"Promoting First Relationships ® is based on attachment theory and is strengths-based. The 12 week intervention is delivered in the home of the family. Each week has a theme for discussion, handouts, an activity, and time for joining - checking in with the parent, listening to their concerns, and establishing a positive, supportive relationship. The provider videotapes playtime between parent and child, and alternates weeks watching the video with the parent, reflecting about the needs of both parent and child (reflective observation). PFR consultation strategies include Joining, Positive Feedback, Instructive Feedback, Reflective Questions and Comments, and Instruction with Handouts. These core strategies enhance parents' sense of security and competency. The provider helps the parent develop greater empathy and understanding of the child's needs and feelings, and helps the parent to identify their own feelings and needs around parenting."
15808136|NCT04382677|Other|Resource & Referral|This condition consists of 1) Resource & Referral assistance provided over the phone, and 2) Local Services Resource Packet. Throughout the intervention period, the provider makes monthly phone calls to offer further support to families, answer questions, and provide additional resources. The provider has at least four interactions with each family served. In addition, families in this condition have the Resource and Referral Specialist's phone number and they can call if an additional need arises. The resource packet includes local information organized by type of need or resource. These packets are updated regularly as services change over time.
15808141|NCT04382651|Drug|MAS825|Single dose of MAS825 by i.v. infusion, in addition to Standard of Care (Soc)
15808142|NCT04382651|Drug|Matching placebo|Single dose of Matching Placebo by i.v. infusion, in addition to Standard of Care (Soc)
15808143|NCT04382638|Combination Product|RCO group|Patients in the experimental group will receive RCO fabrication with standard level of care for bracing, which consists of education on general exercises for spinal movement, strengthening, and balancing. These patients will attend study assessments at baseline, 3 months, 6 months, 12 months and every year until they reach skeletal maturity or if surgical intervention is required.
15808144|NCT04382638|Device|TLSO group|Patients in the experimental group will receive TLSO fabrication with standard level of care for bracing, which consists of education on general exercises for spinal movement, strengthening, and balancing. These patients will attend study assessments at baseline, 3 months, 6 months, 12 months and every year until they reach skeletal maturity or if surgical intervention is required.
15808145|NCT04382625|Drug|Hydroxychloroquine|Hydroxychloroquine is currently widely used for treatment of autoimmune disease including systemic lupus erythematosus and rheumatoid arthritis, and it has been used to prevent and treat malaria.
15808146|NCT04382612|Device|HARPOON Beating Heart Mitral Valve Repair System (MVRS)|Repair of the chordae tendinae in the mitral valve.
15808147|NCT04382599|Behavioral|Text warning with square background|The warning message is in white text on a black square background
15808148|NCT04382599|Behavioral|Text warning with octagon background|The warning message is in white text on a black octagon background
15808149|NCT04382599|Behavioral|Icon warning|The warning message in in white text on a black background, below an icon that conveys the topic the warning is about
15808150|NCT04382599|Behavioral|Graphic warning|The warning message in in white text on a black background, below a graphic that conveys the topic the warning is about
15808151|NCT04382586|Drug|Zanubrutinib|320 mg (4 x 80 mg) capsules administered orally once daily.
15808152|NCT04382586|Drug|Supportive Care|Supportive care treatment is selected and administered as deemed appropriate by the study investigator.
15808153|NCT04382586|Drug|Placebo|Placebo to match zanubrutinib
15808154|NCT04382573|Genetic|Epigenetic signatures|Epigenetic signatures (Dr Sadikovic' lab, London, Ontario, Canada)
15808155|NCT04382560|Other|Deep Breathing training|The intervention will comprise a psychoeducational part on the theorethical background underlying this technique and a pratical session in which partecipant will be instructed to inhale air with his/her nose and exhale with his/her mouth for a period of 3 seconds of inhalation and 7 seconds of exhalation (i.e., 6 cycles of breaths per minute;). During the session, the participant will be encouraged to put one hand over his/her chest and the other over the abdomen in order to see the difference between normal breathing and deep breathing. To help the subjects in the training, an online pacer will give the rhythm of respiration and will be used as visual feedback.
15808156|NCT04382560|Other|Compassion focused intervention|"The short compassion focused intervention will begin with a short psychoeducation on the evolved nature and difficulties of the human mind, such as tendencies for negativity bias, negative rumination, and self-criticism. Participants will then be offered insights into how humans can work with their 'tricky brains' using body-based and psychological-based practices aimed at increasing a grounding and soothing compassionate attitude towards ourselves and others. In particular, participants will be instructed to pratice a mindfulness technique designed to help them to become more aware of their present moment-to-moment and more compassionate towards their own emotions. They will then be guided to create an image conveying warmth and compassion to them. Lastly, participants will be guided to bring the image to mind and then write write a brief self-compassionate letter to themselves from that point of view."
15808157|NCT04382547|Biological|Allogenic pooled olfactory mucosa-derived mesenchymal stem cells|Allogenic pooled olfactory mucosa-derived mesenchymal stem cells
15808158|NCT04382547|Other|Standard treatment according to the Clinical protocols|Standard treatment according to the Clinical protocols
15808159|NCT04382534|Combination Product|Respiratory rehabilitation|Health education and energy saving techniques, chest activity training, local lung dilation techniques, breathing training, airway clearance training, aerobic exercise, resistance training
15808216|NCT04381975|Behavioral|Move in Mind Program|Each of the six Move in Mind sessions will take place once a week for approximately 1.5 hours, with 12-17 individuals participating per class. The material and exercises taught will include physical floor exercises, breathing exercises, as well as awareness training.
15808160|NCT04382521|Behavioral|Text Message Intervention|Participants will undergo a three component intervention consisting of (1) daily, adaptive text messages related to Positive Psychology or health behaviors, (2) twice weekly text messages related to a specific health behavior goal, and (3) three brief check-ins (at baseline, week 4, and week 8 of the intervention) with a study staff member to discuss progress towards health behavior goals. During the brief check-ins, the study staff member will inquire about: (1) medical conditions, (2) adherence gaps, (3) personal health goals (including weight goals), (4) motivation, self-efficacy, and barriers to reaching health goals, (5) preferred activity types (e.g., walking), and (6) sources of sedentary time (e.g., computer, TV). This information will be added to the algorithm for each individual and we will deliver tailored daily text messages for our participants.
15808161|NCT04382508|Other|Questionnaire|A weekly questionnaire will be filled in
15808162|NCT04382495|Other|survey|online survey
15808163|NCT04382456|Dietary Supplement|acacia gum|Two sachets (à 5 g) in the morning and two sachets in the evening, reconstituted in 120 ml water and stirred until fully dissolved to be taken 10 minutes before meals.
15808164|NCT04382443|Drug|Colchicine|At the moment of BMS implantation intervention will mean that this group will receive colchicine as described.
15808165|NCT04382430|Procedure|Ultrasound guided venous access|Each physician/ provider will perform 2 assisted ultrasound (US) guided venous access and pocket creation for cardiac device implant and 10 solo ultrasound guided cardiac device implant.
15808166|NCT04382430|Procedure|Conventional technique|Physician will perform 5 cardiac device implant using conventional technique of venous access and pocket creation
15808167|NCT04382417|Other|Observational study|Not required
15808168|NCT04382404|Drug|Sofosbuvir-Velpatasvir Drug Combination|One pill once a day for 12 weeks
15808169|NCT04382391|Device|gammaCore® Sapphire (non-invasive vagus nerve stimulator)|"Administer gammaCore® Sapphire daily, prophylactically, for three treatments (morning, mid-day and night, one hour before bed), each treatment consisting of two 2-minute doses/stimulations, one on each side of the neck. This would be a total of 6 treatments (2 doses x 3 times per day) of stimulation.
~For acute respiratory distress or shortness of breath (SOB), administer one treatment consisting of two 2-minute stimulations, on the neck. If respiratory distress or shortness of breath persists 20 minutes after the start of the first treatment, administer a second treatment."
15808170|NCT04382391|Other|Standard of care therapies|Will receive standard of care therapies for the treatment of CoViD-19 infection and symptoms
15808171|NCT04382378|Device|neuromuscular electrical stimulation|application of an electric current through electrodes placed on the skin over the targeted musclesto induce skeletal muscle contractions
15808172|NCT04382365|Other|Sleep Health Using the Internet for Older Adult Sufferers of Insomnia and Sleeplessness|Cognitive-Behavioral Treatment for insomnia (CBT-I) is a non-pharmacological intervention that is effective in treating insomnia in older adults, even when present with comorbid medical and psychological conditions.25 CBT-I focuses on the maladaptive behaviors and dysfunctional thoughts that perpetuate sleep problems, and typically consists of five primary treatment components: sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention.
15808173|NCT04382352|Biological|Humanized Anti-HER2 Monoclonal Antibody Compound for Injection .R&D code: B002.|Usage: intravenous infusion; B002, doses 2, 6, 12, 16, 20 mg / kg, intravenous drip. The infusion time was 120 ± 10 minutes for the first time; if the patient was tolerated, the follow-up time was adjusted to 60 ± 10 minutes. Pre-treatment was performed using phenergan (25 mg, intramuscular) within 30 minutes prior to each study drug infusion. The dosing cycle is administered once every 3 weeks for one cycle and can be administered continuously until the disease progresses or is intolerable.
15808174|NCT04382339|Drug|SOF/RBV/PegINFα-2|SOF: block the hepatitis C NS5B protein. RBV: a nucleoside inhibitor PegINFα-2: chemically modified form of the standard interferon that treats hepatitis C
15808175|NCT04382326|Biological|20-valent pneumococcal conjugate vaccine|20-valent pneumococcal conjugate vaccine
15808176|NCT04382326|Biological|13-valent pneumococcal conjugate vaccine|13-valent pneumococcal conjugate vaccine
15808177|NCT04382313|Procedure|the adequate hydration group guided by Vigileo|If the patient is mechanically ventilated, the following scheme is adopted: if SVV≤10%, then adjust the rehydration speed to 1 ml/kg/h; if 10%<SVV<15%, then adjust the rehydration speed to 2 ml/kg/h; if SVV≥15%, then adjust the rehydration speed to 3 ml/kg/h. The hydration lasts 24 hours after operation, and the rehydration speed is changed according to the SVV. If the patient does not use mechanical ventilation, the following scheme is adopted: 250ml normal saline is administered within 10 minutes after direct PCI, and the rehydration volume changes to 125ml in patients with mild-to-moderate congestive heart failure. If the increment of SV≥15%, then adjust the rehydration speed to 3 ml/kg/h; if 10%≤the increment of SV<15%, then adjust the rehydration speed to 2 ml/kg/h; if the increment of SV<10%, then adjust the rehydration speed to 1 ml/kg/h. Reassessed every 1 hour until SV is stable，and the hydration also lasts 24 hours after operation.
15808178|NCT04382313|Drug|Saline|The routine hydration regimen is adopted, perioperative saline ≤500 ml hydration.
15808179|NCT04382300|Drug|pyrotinib combined with thalidomide|Single Group Assignment
15808180|NCT04382287|Procedure|Remin Pro® and MI Paste Plus®|Te toothastes were applied at home twice a day over the six anterior upper primary teeth
15808181|NCT04382274|Procedure|Quadratus Lumborum Block|transducer will be placed at the level of the anterior superior iliac spine and moved cranially until the three abdominal wall muscles will be clearly identified. The external oblique muscle will be followed posterolaterally until its posterior border will be visualized leaving underneath the internal oblique muscle, like a roof over the QL muscle. The probe will be tilted down to identify a bright hyperechoic line that represented the middle layer of the thoracolumbar fascia. The needle will be inserted in plane from anterolateral to posteromedial. The needle tip will be placed between the thoracolumbar fascia and the QL muscle, and after negative aspiration, the correct position of the needle will be proved by injection of 5 mL of normal saline to confirm the space with a hypoechoic image and hydrodissection. An injection of 20 mL of 0.25% bupivacaine will be applied
15808217|NCT04381975|Behavioral|6 Week Waitlist Control|The waitlist control group will receive the Move in Mind program after 6 weeks.
15808218|NCT04381962|Drug|Azithromycin Capsule|Azithromycin 500 mg OD PO 14 days
15808219|NCT04381949|Procedure|positive pressure extubation|"Two arms:
~the first with classic extubation with disconnection of the ventilator and the second with an extubation without disconnection of the respiratory positive pressure"
15808182|NCT04382274|Procedure|Dual Transversus Abdominis Plane and Ilioinguinal/Iliohypogastric Nerve blocks|the probe will be located between the iliac crest and the lower costal margin in the anterior axillary line at the level of umbilicus, and the layers of abdominal wall will be identified (external oblique, internal oblique, and transverse abdominis muscles). In-plane technique will be used and the tip of the needle was inserted between the internal oblique and transverse abdominis muscles. After negative aspiration (to exclude intravascular injection), 20 mL of 0.25% bupivacaine will be injected. Then abdomen will be scanned through anterior superior iliac spine (ASIS)-umbilicus line. Ilioinguinal nerve can be visualised between the internal oblique and transverse or external oblique muscles and within 1 to 3 cm from the ASIS. The iliohypogastric nerve lies immediately adjacent. After negative aspiration (to exclude intravascular injection), 10 mL of 0.25% bupivacaine will be injected. The same technique will be performed on the other side.
15808183|NCT04382261|Procedure|Scaling and root planing|Full mouth or quadrant SRP
15808184|NCT04382248|Other|Smartphone App|An app for monitoring medications, blood pressure, exercise, healthy eating
15808185|NCT04382248|Behavioral|Tailored education|in-person coaching
15808186|NCT04382235|Device|Non-invasive ventilatory support|All non-invasive ventilatory support wll be recorded. All collected data is taken and monitored during normal clinical practice without adding any other tests.
15808187|NCT04382222|Procedure|prenatal ultrasound|prenatal cardiac ultrasound
15808188|NCT04382209|Procedure|Erector spinae plane block|The transducer was placed vertically 3cm lateral to the midline to visualize the muscles of the back, transverse process and the pleura in between the two transverse processes. Bilateral ultrasound guided erector spinae plane block with 20 mL of 0.375% bupivacaine each using an in-plane, cranial-to-caudad approach to contact the bony shadow of the transverse process (TP) with the tip deep to the fascial plane of the erector spinae muscle. The correct location of the needle tip was confirmed by injecting 0.5-1 cc of normal saline 0.9% and observing linear fluid spread lifting the erector spinae muscle off the tip of the TP.
15808189|NCT04382209|Device|Intravenous meperidine patient controlled analgesia device|Intravenous meperidine patient controlled analgesia device will be given to the patients postoperatively and 24 hour meperidine consumption will be recorded
15808190|NCT04382196|Other|Online survey|An online survey will be administered
15808191|NCT04382183|Behavioral|Ketogenic weight loss maintenance diet|The ketogenic weight loss maintenance group will undergo in a ketogenic diet (50 g CHO/day) plant-based for 1 year.
15808192|NCT04382183|Behavioral|Isocaloric balanced weight loss maintenance diet|The isocaloric balanced weight loss maintenance group will undergo in a diet following the recommendations from the Norwegian Health Directorate for 1 year.
15808193|NCT04382170|Drug|Dexmedetomidine sublingual film|Dexmedetomidine sublingual film for the management of agitation in hospitalized patients with delirium.
15808194|NCT04382157|Drug|Mablet 360 mg|Slow-released magnesium hydroxide
15808195|NCT04382157|Drug|Placebo|Placebo
15808196|NCT04382144|Drug|Liposomal bupivacaine|Patient will receive a single injection of a local anesthetic into the common extensor origin.
15808197|NCT04382131|Other|NaCl Solution|NaCl Solution prepared by participants at home using water and salt
15808198|NCT04382118|Other|Data collection from routine medical records|Data collection from routine medical records (clinical and radiological data)
15808199|NCT04382105|Other|Observation of salivary IL-6 levels|Observation of salivary IL-6 levels and correlation of salivary IL-6 levels with periodontal disease
15808200|NCT04382092|Diagnostic Test|FilmArray Pneumonia|Respiratory samples are treated according to routine laboratory testing : culture, immuno assays AND molecular testing (FilmArray PNEU) of the endotracheal aspirate sample 24 hours a day.
15808201|NCT04382079|Dietary Supplement|honey|"Since the patient received radiation therapy, Taiwan Longan Honey has been used for a total of eight weeks.
~Understand the changes of oral mucositis and various symptoms during this period"
15808202|NCT04382079|Dietary Supplement|propolis|"Since the patient received radiation therapy, Taiwan green propolis has been used for a total of eight weeks.
~Understand the changes of oral mucositis and various symptoms during this period"
15808203|NCT04382066|Drug|Plitidepsin 1.5 mg/day|Plitidepsin 1.5 mg/day will be IV infused through a pump device over 1 hour and 30 minutes, 3 consecutive days.
15808204|NCT04382066|Drug|Plitidepsin 2.0 mg/day|Plitidepsin 2.0 mg/day will be IV infused through a pump device over 1 hour and 30 minutes, 3 consecutive days.
15808205|NCT04382066|Drug|Plitidepsin 2.5 mg/day|Plitidepsin 2.5 mg/day will be IV infused through a pump device over 1 hour and 30 minutes, 3 consecutive days.
15808206|NCT04382053|Drug|DFV890|DFV890 administerated in addition to the SoC for 14 days
15808207|NCT04382053|Drug|Standard of Care (SoC)|SoC includes a variety of supportive therapies that ranges from the administration of supplementary oxygen to full intensive care support, alongside the use of antiviral agents and intravenous corticosteroids.
15808208|NCT04382040|Drug|ArtemiC|Treatment will be sprayed orally twice a day for the first 2 days in the treatment period
15808209|NCT04382040|Drug|Placebo|Treatment will be sprayed orally twice a day for the first 2 days in the treatment period
15808210|NCT04382027|Dietary Supplement|Omega-3 + vitamin K2 (monoacylglycerol form)|"The intervention is a randomized double bond cross over design testing the pharmacokinetics of a monoglyceride formulation compared to an ethyl ester form.
~Treatments are randomly assigned on days 0 and 7 of the clinical study. Blood samples will be collected at time 0, 1, 2, 4, 5, 6, 8, 9, 10, 12 and 24 hours. Each participant will perform the two treatments, with a minimum of 6 days between treatments."
15808211|NCT04382027|Dietary Supplement|Omega-3 + vitamin K2 (ethyl ester)|"The intervention is a randomized double bond cross over design testing the pharmacokinetics of a monoglyceride formulation compared to an ethyl ester form.
~Treatments are randomly assigned on days 0 and 7 of the clinical study. Blood samples will be collected at time 0, 1, 2, 4, 5, 6, 8, 9, 10, 12 and 24 hours. Each participant will perform the two treatments, with a minimum of 6 days between treatments."
15808258|NCT04381728|Device|Womed Leaf|Womed Leaf uterine film will be inserted immediately after the myomectomy, following per-operative hysterometry.
15808259|NCT04381715|Genetic|Epigenetic signatures|Epigenetic signatures (Dr Sadikovic' lab, London, Ontario, Canada)
15808235|NCT04381923|Device|Helmet Continuous Positive Airway Pressure (CPAP)|Helmet CPAP will be initiated at a pressure of 5 cmH20 and fraction of inspired oxygen (Fi02) of < 60%. If oxygen saturation (Sp02) remains < 92%, pressure will be increased to 10 cmH20. FiO2 will then be tapered to target a SpO2 ≥ 92%. Breaks with intervening HFNO use will be provided as needed for meals and during hours of sleep.
15808236|NCT04381923|Device|High Flow Nasal Oxygen (HFNO)|HFNO will be initiated at a flow rate of 40 LPM and a fraction of inspired oxygen (Fi02) of < 60%. If oxygen saturation (SpO2) remains < 92%, the flow rate will be increased to 60 LPM. FiO2 will then be adjusted to target a SpO2 ≥ 92%. Patients with discomfort due to HFNO may have their flow rate decreased until the discomfort resolves.
15808237|NCT04381910|Drug|LY01610( Irinotecan hydrochloride liposome injection )|LY01610 will be administered via intravenous infusion every 2 weeks on Day 1
15808238|NCT04381897|Drug|N-acetyl cysteine|Oral solution for N-acetyl cysteine is prepared in syringes and provided to the participants along with instructions on how to administer them.
15808239|NCT04381897|Other|Placebo|NAC Placebo-matching solution is prepared in syringes and provided to the participants along with instructions on how to administer them.
15808240|NCT04381884|Drug|IVERMECTIN (IVER P®) arm will receive IVM 600 µg / kg once daily plus standard care. CONTROL arm will receive standard care.|IVERMECTIN (IVER P®) arm will receive IVM 600 µg / kg once daily plus standard care. CONTROL arm will receive standard care.
15808241|NCT04381871|Dietary Supplement|Acacia Senegal|Oral Digestion of Gum Arabic to be consumed early morning on daily basis for 4weeks
15808242|NCT04381871|Dietary Supplement|Pectin|Oral Digestion of Pectin to be consumed early morning on daily basis for 12 weeks
15808243|NCT04381858|Drug|Plasma from COVID-19 convalescent patient|"Infusion of 400 ml (2 units) of plasma.
~Plasma donated from convalescent patients will be extracted in strict compliance with the following criteria:
~History of a clinical event with symptoms attributed to COVID-19 and a positive PCR test for COVID-19
~Further confirmation of a negative PCR test for COVID-19
~In order to be eligible plasma donors must complete at least 14 days after the last negative PCR in the absence of any symptom attributable to COVID-19 infection
~IgG antibodies for COVID-19 must be confirmed POSITIVE when a qualitative assay is being used
~When quantification of IgG antibodies for COVID-19 is available a title > 1: 640 will be required for inclusion.
~Apheresis will be used as the only method for plasma extraction."
15808244|NCT04381858|Drug|Human immunoglobulin|Human immunoglobulin 0.3 gr/kg/day (5 doses)
15808245|NCT04381845|Diagnostic Test|COVID19 immunization testing|serological COVID19 test with confirmation at J15 during hospitalization
15808251|NCT04381819|Diagnostic Test|SARS-CoV-2 PCR|SARS-CoV-2 E gene
15808252|NCT04381806|Drug|5-ALA|Patients enrolled in this study will receive 3 doses of ALA and fractions of radiation therapy during the course of one 21day cycle. Only one cycle per patient is allowed. Patients are followed through day 56 for adverse event and efficacy measures.
15808253|NCT04381793|Dietary Supplement|Recovery Factors|Porcine serum amino acid/peptide
15808254|NCT04381780|Dietary Supplement|Recovery Factors|A unique porcine serum based polypeptide nutritional support
15808263|NCT04381676|Other|Flipped Classroom Approach|In the Flipped Classroom, participants form groups of 2-3 and are instructed to work together through clinical cases of the in-class case based activity, committing to group answers to the clinical questions before advancing to the next case. At the end of class, the faculty instructor facilitated a short interactive group discussion.
15808264|NCT04381663|Procedure|conservative treatment|conservative treatment for patients with cervical spine stenosis without myelopathy
15808265|NCT04381663|Procedure|surgical treatment|surgical decompress the spinal canal in patients with moderate to severe degenerative cervical spine myelopathy
15808266|NCT04381650|Drug|TAK-981|TAK-981 IV infusion.
15808267|NCT04381650|Drug|Pembrolizumab|Pembrolizumab IV infusion.
15808268|NCT04381637|Device|NIPE monitor|NIPE monitor connected to the anesthetic station. No part of the device in contact with the patient. No action on patient or anesthesia. Automatic recording of Heart rate and NIPE index during the study period.
15808269|NCT04381637|Procedure|Tetanic stimulations|"Three tetanic stimulations will be performed (10-30 and 60 milliamps) under general anesthesia, before surgical incision.
~Stims performed via the muscle relaxation monitor (used in standard practice in this population) Each stim lasts for 5 seconds. Interval between two stims : 3-5 minutes Order on intensities randomized by a latin square of order 3."
15808270|NCT04381624|Other|Exercise program|exercise program in 12 sessions, of approximately one hour, distributed in 3 sessions per week during a month
15808271|NCT04381598|Drug|stevia rebaudiana bertoni|Stevia has an anti-plaque effect because of its ability in decreasing the formation of bacterial insoluble polymers.It significantly decreases the production of TNF-R and IL-1a and slightly decreases the production of NO in stimulated cells with LPS and THP-1 showing its anti-inflammatory properties.These characteristics in combination with anti-diabetic properties could results in the effective treatment of periodontal diseases.
15808272|NCT04381598|Other|placebo|A placebo without the active drug will be placed in the control sites.
15808273|NCT04381585|Device|A MINI DISTRACTOR WITH A SUBMERGED ACTIVATION COMPONENT|Mini distractor is used to regenerate alveolar bone which is resorbed due various reasons. The distractor uses a winch-like submucosal activation component which is buried in the tissue; Flicking the winch turns the screw which moves the segment upwards in the direction of black arrow increasing height.
15808274|NCT04381572|Behavioral|High fidelity simulation training|At the beginning of scheduled classes in the simulation center, students were placed sitting at rest for 30 min. In each team a leader was chosen. Other team members were also assigned detailed functions. Before starting the scenario, participants were oriented for 10 -15 minutes by a physician instructor about the simulation room setup and manikin features. The simulated scenarios were performed using a high fidelity computer-based manikin simulator, with the possibility of remote control of vital signs. All medications and equipment required during the clinical scenarios were available. The scenario used was prepared and validated by experienced simulation instructors. All student groups were given the same standardized scenario.
15808275|NCT04381559|Behavioral|Cognitive Behavioural Therapy|In sessions 1-2, the participant's sexual history and goals regarding social anxiety reduction and HIV risk reduction will be discussed, including reducing CAS, and considering use of PrEP to reduce HIV risk. In sessions 3-4, the role of social anxiety and substances in social avoidance and HIV risk will be discussed, and a fear hierarchy of the participant's social fears will be created. In sessions 5-7, cognitive restructuring and coping skills for anxiety reduction will be discussed. In sessions 8-9, participants will face their fears via exposures to feared situations using their new cognitive coping skills. In sessions 10-11, exposures are continued with a focus on (a) situations higher in the fear hierarchy and (b) the role of substance use as a barrier to personal goals. In session 12, relapse prevention and goals for progress regarding social anxiety, substance use, and HIV risk reduction beyond the end of therapy will be discussed.
15808276|NCT04381559|Behavioral|Applied Relaxation|12 sessions of AR will serve as our second, control arm. In AR, patients are trained in progressive muscle relaxation, and then taught to practice using relaxation when facing feared situations, as a new coping response.86 AR involves noticing early signs of anxiety, learning relaxation skills, and applying relaxation at the first sign of anxiety.87 This therapy is chosen because it does not involve the cognitive and exposure focused techniques that are used in the experimental condition.88 Reviews of psychological treatments show that AR does not statistically differ from cognitive restructuring with exposure in its effects on social anxiety.87 However, AR is an appropriate control arm for the present study because it is credible and can be time-matched to CBT, but has no theoretical or empirical support for substance use management or HIV risk behaviour reduction, the latter of which is the primary outcome of the present study.
15808277|NCT04381546|Other|Functional Electrical Stimulation FES|Functional electrical stimulation (FES) is delivered to the quadriceps and hamstrings of the paretic limb in patients with hemiplegia. It is based on the real-time estimation of the knee angle and support phase during gait.
15808278|NCT04381533|Behavioral|Internet-delivered Adolescent Community Reinforcement Approach (I-A-CRA)|The intervention is a behavioral internet-based intervention based on the Adolescent Community Reinforcement Approach. The program encompasses text, pictures, videos, and written as well as practical assignments (skills training). The main components of the treatment for the young adult with problematic alcohol use consist of psychoeducation and functional analysis, goal formulation, increasing prosocial behaviors, relapse prevention, problem solving, and communication training. The accompanying significant other receives modules containing information focusing on gaining an understanding of the treatment components aimed at the young adult, as well as communication training to improve communication between the young adult and the significant other.
15808279|NCT04381533|Behavioral|Psychoeducation, information on use of alcohol and its effects|The intervention is a behavioural internet-based intervention including psychoeducation focusing on providing information on alcohol, alcohol use, and its effects. The psychoeducation is provided via texts and pictures, and there is a possibility of asking questions to a therapist if needed however no therapist contact is mandatory. There are separate programs directed towards the young adult and the accompanying significant other. The programmes give brief self-help tips at the end. The intervention approximately corresponds to the information given in a primary care setting for someone with problematic alcohol use.
15808280|NCT04381520|Other|Heat-sensitive moxibustion plus antihypertensive drugs|In this arm, patients will administer heat-sensitive moxibustion by themselves or by the help of their family after professional training. Patients will maintain their original antihypertensive drugs. The periods of treatment and follow-up will be one year.
15808281|NCT04381520|Drug|Antihypertensive drugs|In this arm, patients will maintain their original antihypertensive drugs. The periods of treatment and follow-up will be one year.
15808282|NCT04381507|Device|endovascular repair|Endovascular repair of descending thoracic aneurysms or PAU using a stent graft.
15808283|NCT04381494|Device|Multiparametric Mobile Technology|Using a spirometer, an armband, and a tablet to collect data.
15808284|NCT04381481|Behavioral|Experimental Drink: Nutrition claim on fruit drinks|Fruit drink contains a nutrition claim (task 1)
15808285|NCT04381481|Behavioral|Control Drink: No nutrition claim|Fruit drinks does not contain a nutrition claim (task 1)
15808286|NCT04381481|Behavioral|Experimental snack: Text warning|The snack contains a text warning (task 2)
15808287|NCT04381481|Behavioral|Experimental snack: Graphic warning|The snack contains a graphic warning (task 2)
15808288|NCT04381481|Behavioral|Control snack: barcode label|The snack contains a neutral barcode label (task 2)
15808291|NCT04381455|Device|OSSIX Bone|subjects will be implanted with OSSIX Bone during sinus elevation surgery
15808292|NCT04381442|Radiation|Low Level Laser Therapy|
15808293|NCT04381429|Drug|A-F-A-F (NovoRapid-FIASP-NovoRapid-FIASP)|A = pre-prandial aspart insulin (NovoRapid) F = post prandial Faster-acting aspart insulin (FIASP)
15808294|NCT04381429|Drug|F-A-F-A (FIASP-NovoRapid-FIASP-NovoRapid)|A = pre-prandial aspart insulin (NovoRapid) F = post prandial Faster-acting aspart insulin (FIASP)
15808295|NCT04381416|Device|SEAD treatment|up to two 30-min endometrial ablation sessions using the IUB SEAD™ device, in a hospital outpatient clinic
15808296|NCT04381403|Other|Bio-descaling D-Tart toothpaste|Patients received Bio-descaling D-Tart toothpaste, which is a new dentifrice (Visionaturolab Inc., QC) that contains a natural bio-descaler powder of cuttlefish bone
15808297|NCT04381403|Other|Crest® toothpaste|Patients received Crest toothpaste; Anti-tartar toothpaste
15808298|NCT04381390|Dietary Supplement|Whole egg and resistance training|This intervention consisted of whole egg consumption concomitant with 12 weeks of resistance training. Subject ingested three whole eggs per day immediately after resistance training.
15808299|NCT04381390|Dietary Supplement|Egg whites and resistance training|This intervention consisted of egg white consumption concomitant with 12 weeks of resistance training. Subject ingested an isonitrogenous quantity of six egg whites per day immediately after resistance training.
15808300|NCT04381377|Drug|azoximer bromide|Investigational medicinal product
15808301|NCT04381377|Other|Placebo|Placebo
15808302|NCT04381364|Drug|Ciclesonide Inhalation Aerosol|Ciclesonide 320 µg twice daily for 14 days.
15808303|NCT04381338|Other|Pulmonary and Motor Rehabilitation|Pulmonary and Motor Rehabilitation in ICU
15808304|NCT04381325|Drug|MSB0254 Injection|"An intravenous infusion with concentration from 4 mg/kg to 16 mg/kg every 2 weeks (Q2W).
~An intravenous infusion with concentration 20 mg/kg every 3 weeks (Q3W)."
15808307|NCT04381273|Other|No intervention|questionnaire-based assessment
15808308|NCT04381260|Other|No intervention|There is no intervention for patients included in this group as this is a retrospective data registry only.
15808309|NCT04381260|Other|Interview|Key Informant Interview
15808310|NCT04381260|Other|Survey|Stakeholder survey
15808311|NCT04381247|Diagnostic Test|Molecular diagnostics in HAP and VAP|Airway samples will be analyzed both by standard and molecular based microbiological analysis.
15808312|NCT04381234|Device|dialyzer|Asymmetric triacetate dialyzer
15808313|NCT04381234|Combination Product|hemodialysis with citrate-containing dialysate|acetate-free dialysate
15808314|NCT04381234|Other|predilution hemodiafiltration|predilution hemodiafiltration
15808315|NCT04381208|Diagnostic Test|Complete clinical examination|Medical history-taking, physical examination with provocative maneuvers, radiographic imaging (if relevant), and sacroiliac joint block (if indicated), facet joint block (if indicated)
15808316|NCT04381195|Diagnostic Test|AFS Development|Complete drafting of an item pool (adults with ASD, parents, adult service providers); Assign items to all parts of our conceptual framework to ensure sufficient construct coverage across employment, social, and independent living domains; and Conduct cognitive interviews with 25 caregivers of adults with ASD and 25 self-reporting adults with ASD.
15808317|NCT04381195|Diagnostic Test|AFS Testing|A national sample of proxy reporters (e.g., parents, clinicians, group home staff) for 500 adults with ASD representative of the full range of verbal and intellectual functioning and 500 self-reporting adults with ASD will complete the AFS draft items and a co-calibration battery to establish psychometrics, generate short-forms, and ensure applicability across adults with ASD.
15808318|NCT04381182|Device|Apollo Wearable Device|Participants wear Apollo device which generates vibration frequencies on skin and can be controlled by the user
15808319|NCT04381169|Drug|Lactated Ringer Solution|Comparison of aggressive versus moderate Lactated Ringer-based fluid resuscitation
15808321|NCT04381130|Drug|EF-009|"Subjects who meet the eligibility criteria will have completed following evaluations and assessments before receiving treatment: a) review of medical and medication history; b) physical examination, vital signs and documentation of ECOG; c) ECG; d) routine serum biochemical, hematologic, urine pregnancy (if applicable) and urine laboratory assessments; and e) evaluation of European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 score.
~On Day 0, subjects will undergo EF-009 wafer implantation via laparoscopy"
15808322|NCT04381117|Drug|Previously Treated with EN3835|No treatment to be administered - Observational only
15808325|NCT04381078|Other|ACE - AudioVisual Guide|Audiovisual guide to Alveolar Bone Graft Procedure, Pre-surgical orthodontics and post-operative care
15808326|NCT04381065|Device|Personal KinetiGraph® (PKG®) System|"The Personal KinetiGraph (PKG®) System consists of the following:
~A wrist-worn movement recording device known as the PKG® Watch, designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period
~Proprietary algorithms to translate raw movement data collected by the PKG® Watch
~Data-driven report known as the PKG®
~The PKG® provides continuous, objective, ambulatory assessment of the treatable and disabling symptoms of Parkinson's disease including tremor, bradykinesia and dyskinesia. The PKG® also provides an assessment of daytime somnolence and an indication of propensity for impulsive behaviors."
15808327|NCT04381065|Device|Personal KinetiGraph® (PKG®) Watch|"The Personal KinetiGraph (PKG®) System consists of the following:
~A wrist-worn movement recording device known as the PKG® Watch, designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period
~Proprietary algorithms to translate raw movement data collected by the PKG® Watch"
15808328|NCT04381052|Drug|Clazakizumab|Dose is 25mg intravenously over 30 minutes.
15808329|NCT04381052|Other|Placebo|Intravenously administered over 30 minutes.
15808331|NCT04381026|Dietary Supplement|Botanical dry extracts combination|Aframomum melgueta dry extract (50mg), Glycine max bean dry extract (100mg) and Punica granatum skin extract (100mg)
15808332|NCT04381026|Dietary Supplement|Placebo|Filler agent
15808333|NCT04381013|Device|Emergency Ventilator Splitter|Device to enable oxygen delivery to two patients independently from a single ventilator.
15808334|NCT04381000|Other|Exercise Group|The group follows warm up exercise (maximum 10 minutes). This consisted of combined, breathing techniques, low-impact aerobic exercises, free range of motion exercises of upper and lower limbs and spine, and coordination-based exercises of hands and feet. Breathing techniques take regular activities such as sitting, walking, and lying down. At the end of this phase, active stretching exercises of major muscles of arm, leg and trunk were performed.
15808335|NCT04380987|Biological|Biological sampling|For every symptomatic adult tested positive by RTqPCR, up to 45 mL of blood will be taken, nasopharyngeal and oropharyngeal swab will be performed, an induced sputum and a stool samples will be recovered at the inclusion. As follow-up, 3 weeks after inclusion, up to 45 mL of blood will be taken and a new induced sputum will be recovered.
15808336|NCT04380974|Procedure|OCTA plus OCT guided 3+PRN regimen|"For the OCTA plus OCT guided 3+PRN regimen, we recorded patients' data after retreatment by 3 monthly intravitreal injections of anti-VEGF drug. Subsequent reinjections were given as needed according to the changes in patients' visual acuity, activity of PCV lesions shown by OCTA and/or the exudation shown by OCT. Four weeks after the third and last injection, all patients in this group underwent an examination, including ETDRS visual acuity, fundus photography, OCTA and OCT.
~In case of BVN increased or polypoidal lesion progressed on OCTA scans, persistent subfoveal or perifoveal fluid, macular intraretinal edema on OCT scans, or visual loss of >5 letters, or the occurrence of a new hemorrhage, patients were retreated. The persistence of hemorrhage without evidence of fluid was not considered a criterion for retreatment. In the absence of retreatment criteria, no further injections were given and another examination was proposed usually 4 weeks later."
15808337|NCT04380974|Procedure|OCT guided 3+PRN regimen|"For the OCT guided 3+PRN group, we recorded patients'data after retreatment by 3 monthly intravitreal injections of Anti-VEGF drugs. Subsequent reinjections were given as needed according to the changes in patients'visual acuity and/or the exudation shown by OCT. Four weeks after the third and last injection, all patients in this group underwent an examination, including ETDRS visual acuity, fundus photography, and OCT.
~In case of persistent subfoveal or perifoveal fluid, macular intraretinal edema, visual loss of >5 letters, or the occurrence of a new hemorrhage, patients were retreated. The persistence of hemorrhage without evidence of fluid was not considered a criterion for retreatment. In the absence of retreatment criteria, no further injections were given and another examination was proposed usually 4 weeks later."
15808338|NCT04380974|Drug|Anti-VEGF drug|Conbercept or other anti-VEGF drugs
15808339|NCT04380961|Drug|Sirukumab|Participants will receive single dose infusion of sirukumab on Day 1.
15808340|NCT04380961|Drug|Placebo|Participants will receive placebo IV single dose infusion on Day 1.
15808341|NCT04380961|Other|Standard of Care (SOC)|SOC treatment will be determined by the investigator based on local practice and consists of supportive care.
15808342|NCT04380935|Biological|Convalescent plasma|Convalescent plasma of recovered COVID-19 patients (donor)
15808343|NCT04380935|Drug|Standard of care|"According to national or hospital guidelines COVID-19 Management Protocol"
15808344|NCT04380922|Other|Periodontal screening|Periodontal data collection (PPD, REC, CAL)
15808345|NCT04380909|Behavioral|Internet-based self-help|Six cognitive-behavioral, mindfulness and acceptance commitment based modules focusing on different aspects of psychological distress due to the Covid-19 situation.
15808346|NCT04380909|Behavioral|Internet-based self-help after 3 weeks|Six cognitive-behavioral, mindfulness and acceptance commitment based modules focusing on different aspects of psychological distress due to the Covid-19 situation.
15808347|NCT04380896|Other|Blood test|Blood tests (8ml in total) 4ml blood for serological testing (measure the antibody titres to the SARS-CoV-2 nucleo-capsid protein (4ml) and 4ml EDTA to be stored for future research will be taken for each group.
15808348|NCT04380896|Other|Standardised questionnaires|It will be an online questionnaire about staff members health, symptoms of SARS-CoV-2 and contact with SARS-CoV-2. All participants will also be asked to complete a detailed symptom and electronic questionnaire prior to each appointment.
15808349|NCT04380883|Device|InnoSEAL+TRB|InnoSEAL is a catecholamine chitosan-based pad (InnoSEAL hemostatic pad, InnoTherapy, Inc.). Chitosan-Catechol in InnoSEAL instantly forms an adhesive barrier upon blood contact. It is intended for use under the care of a healthcare professional. The dressing is indicated for the skin surface puncture sites for vascular procedures, percutaneous catheters/tubes. TRB is a pneumatic device which is applied routinely at the puncture site and inflated with air to stop bleeding from the access site. We will apply InnoSEAL and TRB together.
15808350|NCT04380883|Device|TRB alone|TRB is a pneumatic device which is applied routinely at the puncture site and inflated with air to stop bleeding from the access site. It will be the comparing arm.
15808812|NCT04376944|Other|Survey|questionnaire on their symptoms and their exposures
15808351|NCT04380870|Dietary Supplement|Chinese Herbal Medicine|Chinese Herbal Medicine (CHM) has been used in the prevention and treatment of epidemic diseases dating back to the Han, Ming and Qing Dynasties and extending al the way through modern times. CHM formulas may contain plant elements of root, seed, back, stem or leaf in addition to minerals and other natural substances. All herbs dispensed in this trial will be from Spring Wind Herb Company.
15808352|NCT04380857|Drug|Dexamethasone ophthalmic insert 0.4 mg|intrcanalicular dexamethasone insert
15808353|NCT04380844|Other|Beprevent|10 will become part of the intervention group. At first, they are given a series of questionnaires, later (1 day later) we stay at their home to install the Beprevent device, which will remain in their home for a period of two weeks, to finish and once the device of your home, we will proceed to pass the same questionnaires as at the beginning of the test, in order to compare results.
15808354|NCT04380831|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo HSCT
15808355|NCT04380831|Drug|Cyclophosphamide|Undergo HSCT
15808356|NCT04380831|Radiation|Intensity-Modulated Radiation Therapy|Undergo TBI using IMRT
15808357|NCT04380831|Procedure|Total-Body Irradiation|Undergo TBI using IMRT
15808358|NCT04380818|Radiation|Low-dose radiotherapy|Bilateral low-dose lung irradiation: 0.5 Gy in a single fraction. Optionally, additional 0.5 Gy fraction 48h later
15808359|NCT04380818|Drug|Hydroxychloroquine Sulfate|200 mg/12h for 5 days
15808360|NCT04380818|Drug|Ritonavir/lopinavir|400/100 mg/12h for 7-10 days
15808361|NCT04380818|Drug|Tocilizumab Injection [Actemra]|600 mg/day for 1-2 doses
15808362|NCT04380818|Drug|Azithromycin|500 mg/24h for 3 days
15808363|NCT04380818|Drug|Corticosteroid|Corticosteroids (methylprednisolone/dexamethasone/prednisone)
15808364|NCT04380818|Drug|Low molecular weight heparin|low molecular weight heparin (LMWH) in prophylaxis of venous thromboembolism
15808365|NCT04380818|Device|Oxygen supply|Oxygen
15808366|NCT04380805|Biological|AK104|All subjects will receive AK104 as a single agent at a dose of 6 mg/kg Q2W (Day 1 and Day 15 of each 28 day treatment cycle) via IV infusion.
15808367|NCT04380766|Procedure|Evaluation of changes in the diagnostic-therapeutic pathway for patients affected by pancreatic cancer|Comparison between the pre-COVID and COVID groups of general, clinical, endoscopic and surgical outcomes
15808368|NCT04380753|Drug|AMG 510|Subjects will be enrolled and will receive AMG 510 PO QD.
15808369|NCT04380740|Drug|Placebo|During the extended dosing of abatacept, those randomized to receive 4 doses will receive a placebo consisting of an equal volume of normal saline solution.
15808370|NCT04380740|Drug|Abatacept|Investigational prophylaxis with extended-dosing abatacept, a calcineurin inhibitor and methotrexate.
15808371|NCT04380701|Biological|BNT162a1|Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.
15808372|NCT04380701|Biological|BNT162b1|Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.
15808373|NCT04380701|Biological|BNT162b2|Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.
15808374|NCT04380701|Biological|BNT162c2|Anti-viral RNA vaccine for active immunization against COVID-19 administered as intramuscular injection.
15808375|NCT04380688|Drug|Acalabrutinib|Acalabrutinib administered orally
15808376|NCT04380675|Other|Music|Music listening during ESWL
15808377|NCT04380662|Other|Risk factors|"The studied potential risk factors will be the following:
~Socio-demographic: age, sex, place of residence, CSP and income.
~Comorbidities or aggravation: COPD, asthma, immunosuppression, or heart failure, diabetes imbalance, etc.
~Clinical signs: asthenia, dyspnea (kinetics), blood sugar, nutritional status, weight gain…
~Drugs other than those related to the infection and potential self-medication (anti-inflammatory, CEI, ARA…)"
15808378|NCT04380649|Device|New headset prototype|creation of a new headset prototype for using the P300 Speller, comfortable to use in everyday life by people with disabilities.
15808389|NCT04380623|Behavioral|Mobile Phone-Based Web-Page: HPV vaccine|Website to be accessed via mobile phone to deliver tailored educational material
15808390|NCT04380610|Diagnostic Test|iohexol GFR|We will perform mGFR in 400 SCA patients
15808391|NCT04380597|Drug|Calcipotriene and betamethasone dipropionate aerosol foam|Prescribed according to clinical practice and following Product Data Sheet instructions
15808392|NCT04380584|Diagnostic Test|plasma Apelin level|blood sample for detection of plasma Apelin level
15808393|NCT04380571|Device|Biofeedback|Biofeedback therapy in addition to the conventional measures done in the control Group. It was performed in the same position used for baseline manometry. The used protocol included strength and sensory training, twice weekly for 3 months. Strength training was performed by a double-lumen rectal PVC balloon clothed catheter (MMS U-72210).
15808394|NCT04380571|Device|Electrical stimulation|A positive auto adhesive electrode was applied above the medial malleolus over the S3 dermatome. A second negative electrode was applied just below the same malleolus. Both electrodes were linked to an electrical stimulation device ( EMS physio Ltd, OX129 F, England) with a low frequency current (10 Hz), and adjustable intensity.
15808395|NCT04380571|Other|Traditional treatment|Conventional treatment through Kegal exercises and dietetic regulation where they had received bulky food including vegetables, fruits bran and cereals. Fast foods, spicy drinks and caffeine should be limited in child's diet. Local hygiene and zinc oxide application to the perianal skin were advised to prevent skin excoriation.
15808465|NCT04379999|Drug|Atorvastatin 20mg AND Aspirin 325 mg|History of colorectal cancer and/or history of colorectal adenomas within 5 years.
15808396|NCT04380558|Other|Pulmonary rehabilitation|"Patients will be asked to answer two questionnaires about urinary incontinence symptoms (see outcomes) to assess the prevalence and the type of these symptoms.
~They will subsequently participate in their usual pulmonary rehabilitation program consisting in 90min sessions (including endurance training, muscle strengthening and self-management), 3x/week for 8weeks (centre 1) or 2x60min sessions (including the same components), 3x/week for 8weeks (centre 2)."
15808397|NCT04380545|Drug|Fluorouracil|Given IV
15808398|NCT04380545|Biological|Nivolumab|Given IV
15808399|NCT04380545|Biological|Recombinant Interferon Alpha 2b-like Protein|Given SC
15808400|NCT04380532|Biological|V-SARS|Therapeutic vaccine formulated as a pill derived from heat-inactivated plasma from COVID-19 patients administered once-per-day to at least 20 healthy volunters for at least one month
15808401|NCT04380519|Biological|RPH-104 80 mg|solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL glass vial
15808402|NCT04380519|Drug|Olokizumab 64 mg|solution for subcutaneous administration 160 mg/mL, in the 2-mL glass vial (target volume 0,4 ml)
15808403|NCT04380519|Drug|Placebo|Normal Saline (0.9% Sodium Chloride solution for Injection), in the market package
15808404|NCT04380506|Procedure|Surgical Drains Management|The Role of Amylase Drain Level in the Management of Surgical Drains after Pancreratoduodenectomy
15808405|NCT04380493|Diagnostic Test|hepatic transient elastography using S probe and M probe|
15808406|NCT04380480|Combination Product|Concurrent chemoradiotherapy combined with enteral feeding by percutaneous endoscopic gastrostomy|"One or two weeks before CCRT, all patients will undergo a percutaneous endoscopic gastrostomy (PEG) to be administered enteral nutrition support(30-35 kcal/kg of energy, 1.2-1.5g/kg of protein and electrolyte supplementation each day). Nutritional supplements will be administered till 1 month after CCRT.
~All patients will receive definitive radiotherapy combined with three cycles of S-1 (40mg/2, BID, po) on D1-14, D22-35, D43-56."
15808407|NCT04380467|Dietary Supplement|Vitamin D (cholecalciferol)|(aviticol) 5x 20,000unit capsules administered monthly over 20 weeks
15808408|NCT04380454|Device|Grass S8800 stimulator with SIU8TB stimulus isolation unit; UDel stimulator|Functional electrical stimulation (FES) is a targeted intervention that provides motor level stimulation-induced cues to improve ankle propulsion. An electrical stimulator will be used to deliver stimulation during walking (Grass S8800 stimulator with SIU8TB stimulus isolation unit; UDel stimulator). A customized, real-time system will be used to control the stimulator and deliver stimulation during appropriate phases of the gait cycle. Stimulation will be delivered to the ankle dorsiflexors when the subject's foot is in the air (swing phase). Stimulation will be delivered to the ankle plantarflexors during the terminal stance phase of gait. 30-Hz variable frequency stimulation trains 170 will be delivered during gait. It comprises 18 training sessions (3/week). FES intensity is determined at the start of every training session as motor-level stimulation that elicits appropriate functional movements.
15808409|NCT04380454|Other|Fast treadmill walking|Fast treadmill walking (Fast) is a non-targeted intervention where no specific instructions are provided to target practice to the paretic leg or specific ankle deficits.It comprises 18 training sessions (3/week). Each training session includes six 6-minute walking bouts with 5-minute breaks between bouts
15808410|NCT04380428|Other|No Intervention. Observational study.|No Intervention. Observational study.
15808411|NCT04380415|Diagnostic Test|Single lead ambulatory ECG patch|Single lead ambulatory ECG patch worn on the chest
15808412|NCT04380402|Drug|Atorvastatin|Atorvastatin 40 mg tablet
15808413|NCT04380389|Diagnostic Test|hypoxia|Brief stable arterial oxygen desaturation in healthy volunteers and sampling arterial blood when a stable level of hypoxia has been attained.
15808414|NCT04380376|Drug|Melphalan|Inhalations with low doses of Melphalan for 7-10 consequent days
15808415|NCT04380376|Other|Standard of care|the patients will receive only SOC (standard of care) treatment
15808416|NCT04380363|Device|Honda Walk Assist (HWA) device|Use of HWA for 2 months in the home setting
15808417|NCT04380363|Other|SRALab fitness center membership|Membership to Shirley Ryan AbilityLab fitness center for 2 months
15808418|NCT04380337|Drug|FOLFOXIRI|Chemotherapy regimen of Oxaliplatin 85mg/m2 , Leucovorin 400 mg/m2 , Irinotecan 165mg/m2 , 5-Fluorouracil
15808419|NCT04380337|Drug|FOLFOX regimen|Chemotherapy regimen of Oxaliplatin 85mg/m2, Leucovorin 400 mg/m2, 5-Fluorouracil 2400mg/m2
15808420|NCT04380337|Drug|XELOX|Chemotherapy regimen of Oxaliplatin 130 mg/m2, Capecitabine 1000mg/m2
15808421|NCT04380337|Radiation|IMRT|Radiotherapy (5 Gy x 5 fractions) with an additional boost fraction (5 Gy x 1 fraction) delivered sequentially
15808422|NCT04380324|Drug|LY3471851|LY3471851 drug product is a sterile liquid for SC injection that may be diluted with sterile 0.9% sodium chloride solution for injection (USP) prior to administration.
15808423|NCT04380324|Drug|Placebo|The placebo dosing solution is 0.9% sodium chloride for injection (USP).
15808424|NCT04380311|Device|Tacrolimus Dosing Support Tool|The tacrolimus dosing support tool is based on a population pharmacokinetic model that incorporates patient specific factors including age, renal function, and concomitant medications.
15808425|NCT04380298|Drug|Ketorolac|30ml of local infiltration solution containing 60mg ropivacaine
15808426|NCT04380298|Drug|Ropivacaine|30ml of local infiltration solution containing 6mg ketorolac
15808427|NCT04380298|Drug|Epinephrine|30ml of local infiltration solution containing 0.1mg epinephrine
15808428|NCT04380285|Device|Custom heel pads and modified soft molded orthotics|
15808429|NCT04380285|Device|Custom hard orthotic|
15808430|NCT04380272|Diagnostic Test|The ROC analysis|The Brodsky clinical stage and ultrasonographic data of the participants will be matched, and the diagnostic value of the submental US in the classification of tonsil hypertrophy as non-obstructive and obstructive will be evaluated. A ROC analysis will be used to determine the optimal cut-off value.
15808467|NCT04379973|Drug|Lipiodol Ultra Fluide®|Tubal flush with 5-10mL oil-soluble contrast medium (OSCM) (Lipiodol Ultra Fluide®, Guerbet, France) immediately after Hyfosy. The use will be off-label.
15808468|NCT04379960|Other|Peptides|Peptides will be added to PBMCs in in vitro cell culture.
15808469|NCT04379947|Procedure|Fractional Flow reserve|Measurement of fractional flow reserve in the preoperative work-up for oronary artery bypass surgery
15808470|NCT04379934|Dietary Supplement|3-hydroxybuturate|3-hydroxybuturate will be administered directly as a modified Krebs Henseleit buffer in a super perfused atrial strips model
15808431|NCT04380259|Behavioral|Mindfulness-Based Trauma Recovery for Refugees (MBTR-R)|"MBTR-R is a mindfulness-based group intervention of nine 2.5-hour weekly sessions. MBTR-R format and structure parallel MBSR (mindfulness-based stress reduction) and MBCT (mindfulness-based cognitive therapy). MBTR-R includes systematic training in formal and informal mindfulness practices with trauma-sensitive adaptations and home practice. Trauma-sensitive adaptations include a safe place practice, psychoeducation about posttraumatic stress, stress reactivity, as well as self-compassion practices to cope with fear, self-judgement, guilt and shame. Socio-cultural adaptations include real-time linguistic translation of each session by a cultural mediator from the refugee community and use of socio-culturally specific metaphors. MBTR-R groups were conducted for men and women separately and delivered in an accessible, safe space in the local refugee community. Group meetings included a shared meal of traditional Eritrean food and female participants were offered free child care."
15808432|NCT04380246|Other|Qualitative Interview|There is no intervention as part of this study. Clinicians will participate in a qualitative interview.
15808433|NCT04380233|Drug|Investigational drug for Functional Dyspepsia-Postprandial Distress Syndrome|The investigational drug is a new pure type of gastrointestinal function modulator traditional Chinese medicine, composed of 4 kinds of Chinese herbs: Rhizoma Atractylodis Macrocephalae, Fructus Aurantii Immaturus, Radix Bupleuri and Fructus Crataegi. The preliminary clinical trial showed that it has a good therapeutic effect on FD patients, its Fructus Aurantii Immaturus promotes gastric emptying by stimulating the cells to release motilin, thereby significantly improving patients' symptoms of fullness, epigastric pain, eructation, and nausea and vomiting.
15808434|NCT04380233|Drug|Placebo capsules|The placebo consist of mainly starch and microcrystalline cellulose, the usage and dosage are the same as the investigational drug.
15808435|NCT04380220|Diagnostic Test|Blood samples and processing|DSC perfusion technique at 3.0-T MRI only in MS patients
15808436|NCT04380207|Drug|QPX7728|antibiotic
15808437|NCT04380207|Drug|Placebo|Placebo comparator
15808438|NCT04380207|Drug|QPX2014|antibiotic
15808439|NCT04380194|Diagnostic Test|nano-composite screening|Recovery of the bottoms of the victims' blood and urine tubes at H+4. Blood and urine samples from the victims at two years of age. Single blood and urine samples from the witnesses
15808440|NCT04380181|Drug|dobu|Use of dobutamine versus milrinone and epinephrine for separation from cardiopulmonary bypass
15808441|NCT04380168|Procedure|Modified pec11 trunk block|Ultrasound guided modified pec 11 block injecting local anesthetic with or without adjuvant between pectoralis minor and serratus anterior muscles
15808442|NCT04380155|Other|Exercise|Moderate intensity cycling trials of different duration (30, 60 and 120 min)
15808443|NCT04380142|Drug|ABBV-951|Solution for continuous subcutaneous infusion (CSCI)
15808444|NCT04380142|Drug|Placebo for Levodopa/Carbidopa (LD/CD)|Oral capsule
15808445|NCT04380142|Drug|Levodopa/Carbidopa (LD/CD)|Oral encapsulated tablet
15808446|NCT04380142|Drug|Placebo for ABBV-951|Solution for continuous subcutaneous infusion (CSCI)
15808447|NCT04380129|Other|Music therapy-conversation sessions|"The intervention will be performed four times per patient at a frequency once weekly. An effort shall be made to ensure that each treatment is exactly seven days from the previous one within ± one day. Each session is expected to last approximately seventy minutes (75'). The musical hearing will include Helen Bonny's short program Caring short version, which is proposed by the author of this Music therapy model as the most suitable for patients with chronic and severe pain. The program is as follows:
~Haydn - Cello Konzert in C, Adagio with duration 9:42
~Dvorak - Serenade in E-Dur, Larghetto with duration 6:49
~Warlock - Capriol Suite, Pieds en I'air with duration 2:21"
15808448|NCT04380129|Other|Discussion sessions|Discussion sessions without the application of music therapy
15808449|NCT04380116|Device|Soberlink|Soberlink is a comprehensive alcohol monitoring system designed to remotely monitor a person's Blood Alcohol Concentration (BAC). Combining a professional grade handheld breathalyzer with wireless connectivity, the technology includes real-time facial recognition, robust tamper detection and real-time alerting.
15808450|NCT04380103|Drug|XELOXIRI/Bevacizumab|bevacizumab 5mg/kg on day1, irinotecan 150mg/m2 or 165mg/m2 on day1, oxaliplatin 85mg/m2 on day1 and capecitabine 1000mg/m2 twice a day on day1-7 repeated every 2 week for 12 cycles, after 12 cycles, bevacizumab 5mg/kg on day 1 and capecitabine 1000mg/m2 twice a day on day1-7 as maintenance therapy repeated every 2 week
15808451|NCT04380090|Drug|Propylene Glycol|Patients in the propylene glycol arm will receive one standard dose of the drug on postoperative day one prior to discharge with the aim of decreasing rates of postoperative constipation for patients following single total knee replacement surgery
15808452|NCT04380090|Drug|Docusate Sodium|Patients in the docusate sodium arm are receiving the current standard of care for prevention of postoperative constipation following single total knee replacement surgery, docusate sodium one pill twice a day by mouth for 28 days
15808453|NCT04380077|Procedure|SF6|PPV with SF6 as vitreous substitution
15808454|NCT04380077|Procedure|Fluid|PPV with BSS as vitreous substitution
15808455|NCT04380064|Procedure|ILM Peeling|ILM peeling performed during primary PPV for PDR
15808456|NCT04380064|Procedure|No ILM Peeling|ILM peeling not performed during primary PPV for PDR
15808457|NCT04380051|Behavioral|sensory-tonic stimulation|sensory-tonic stimulation done by the parents to the child, five times a week during 15 minutes at each time
15808458|NCT04380051|Behavioral|skin-to-skin contact|skin-to-skin contact left free for parents
15808460|NCT04380025|Dietary Supplement|Experimental: Oral Mirtogenol|The experimental arm is Oral Mirtogenol dietary supplement, one capsule daily in addition to bimatoprost ophthalmic drops with primary open angle glaucoma
15808461|NCT04380025|Dietary Supplement|Placebo of oral Dietary supplement|This is the oral placebo of the supplement (control) un daily capsule in addition to the bimatoprost ophtalmic drops
15808462|NCT04380012|Drug|Pyrotinib|Pyrotinib as interventions were used in patients with HER2-positive advanced colorectal cancer
15808463|NCT04380012|Drug|Pyrotinib in combination with trastuzumab|Pyrotinib in combination with trastuzumab as interventions were used in patients with HER2-positive advanced colorectal cancer
15808464|NCT04379999|Drug|Atorvastatin 20mg|No history of colorectal cancer and no colorectal adenomas within 5 years.
15808471|NCT04379921|Device|Apple Watch and App|Participants in the Apple Watch and App arm will receive an Apple Watch and download an App (NeuroCoach). The Apple Watch and App are used for this study to record patient's mobility information (e.g., step counts, heart rate, stairs climbed, distance traveled) as well as provide an additional platform for patients to complete questionnaires.
15808472|NCT04379895|Device|Radiofrequency ablation|Pulsed or heated RF ablation of the genicular nerves will be done as an Acceptable treatment for OA of the knee
15808473|NCT04379882|Device|Digital Sedation (Silva)|Use of Digital Sedation (virtual reality associated with psychological interventions) for preoperative anxiety management
15808474|NCT04379869|Drug|NNZ-2591|Single dose of NNZ-2591
15808475|NCT04379869|Drug|Placebo|Comparator for double-blind MAD
15808476|NCT04379856|Drug|NM-002|NM-002 is a fusion protein, of which the pharmacological active portion is the glucagon-like peptide-1 (GLP-1) analog domain with the same amino acid sequence as the active pharmaceutical ingredient (exenatide)
15808477|NCT04379830|Dietary Supplement|Very Low Energy Diet|Optifast 900 is an FDA approved commercial nutritionally complete meal replacement product manufactured and marketed in the United States. Optifast 900 will be employed as part of the VLED in the present study in the following manner: Optifast 900 with a single piece of fruit for breakfast, Optifast 900 with one cup of vegetables for lunch, and Optifast 900 with one cup of vegetables for dinner. Patients will be provided written information on fruits and vegetables permitted for consumption with Optifast 900 to provide a total energy intake between 450 and 800 kilocalories (kcal) per day.
15808478|NCT04379817|Diagnostic Test|Gallium-68 labelled DOTA-conjugated SSTR targeting peptide PET/CT|Assess somatostatin receptor expression
15808479|NCT04379804|Procedure|Lateral approach|Following the ligation of upper pole vessels, the thyroid lobe was pulled anteromedially and the RLN was dissected within the carotid triangle at the level of inferior thyroid artery (ITA).
15808480|NCT04379804|Procedure|Cranio-caudal approach|Following the ligation of upper pole vessels, the upper pole was retracted antero-medially to expose crico-pharyngeal muscle. The RLN was identified at the point of entry both visually and with hand held stimulation probe
15808481|NCT04379791|Other|Data collection from routine medical records|Data collection from routine medical records for criteria for fracture related infections (FRI) and for wound complications. Data collection from routine medical records for risk factors.
15808482|NCT04379778|Other|Aerobic exercise|Progressive moderate to high intensity aerobic exercise.
15808483|NCT04379765|Behavioral|Exercise and physical therapy|Decompression operation
15808484|NCT04379752|Device|Cold-atmospeheric pressure plasma activated aqueous-alcohol solution treatment|Cold plasma is generated and applied to carrier liquid. Subjects are provided with the liquid to apply to the treated area
15808485|NCT04379739|Drug|Camrelizumab|camrelizumab 200mg, q3w, i.v., 2-4 cycles;
15808486|NCT04379726|Behavioral|therapeutic optimization|patients with diagnosis of CFRD will undergo the gold standard treatment for the disease (insulin therapy)
15808487|NCT04379713|Biological|20-valent pneumococcal conjugate vaccine|Pneumococcal conjugate vaccine
15808488|NCT04379713|Biological|13-valent pneumococcal conjugate vaccine|Pneumococcal conjugate vaccine
15808489|NCT04379700|Procedure|Transcatheter arterial embolization|Transcatheter arterial embolization of one or more genicular artery(ies) using Embozene™ Color-Advanced Microspheres. Embozene™ Color-Advanced Microspheres are spherical, tightly calibrated, biocompatible, non-resorbable, hydrogel microspheres coated with an inorganic perfluorinated polymer used for embolization.
15808490|NCT04379700|Device|Embozene™ Microspheres|Embozene™ Microspheres are spherical, tightly calibrated, biocompatible, nonresorbable, hydrogel microspheres coated with an inorganic perfluorinated polymer (Polyzene™-F). The microspheres intended to occlude vasculature for the purpose of blocking blood flow to a target tissue. They are available in prefilled syringes in a range of sizes suitable for embolic therapy. The microspheres are compressible to enable smooth delivery through the indicated delivery catheter and color-coded by size to allow for easy identification. 250 μm microsphere will be used and are supplied in prefilled yellow syringes.
15808491|NCT04379687|Other|Virtual reality|Use of virtual reality glasses for balance work
15808492|NCT04379687|Other|Control group|Balance treatment with according to Bayouk physiotherapy
15808493|NCT04379674|Other|FACILITATION TAPING|The muscle technique, which is a kinesio tape technique, will be used in the biceps brachii muscle. Taping was done with 25% tension with Y tape from the origin to insertion of the muscle.
15808494|NCT04379674|Other|INHIBITION TAPING|The muscle technique, which is a kinesio tape technique, will be used in the biceps braki muscle. Taping was done with 25% tension with Y tape from the insertio to origo of the muscle.
15808495|NCT04379674|Other|PLACEBO TAPING|Unlike Kinesio taping muscle technique, it was performed with horizontal taping on the muscle. The ends of the kinesio tapes will be applied tension-free without overlapping with I tape.
15808496|NCT04379661|Behavioral|Online support Group|12 one-hour, once-weekly online support groups for people with Multiple Sclerosis to address anxiety related to the COVID-19 outbreak and its effects on them.
15808497|NCT04379648|Other|self-assessment and hetero-assessment|Self assessment for the passing of the following rating scales CTQ-SF36-ITQ-PCL5-DES Hetero-assessment for the pasing of the following rating scales DDIS FR and medical interview
15808498|NCT04379635|Drug|Tislelizumab|200/400 mg administered via Intravenous (IV) injection on Day 1, given every 21 or 42 days
15808499|NCT04379635|Drug|Cisplatin injection|75 mg/m^2 administered via IV infusion on Day 1, given every 21 days
15808500|NCT04379635|Drug|Paclitaxel injection|175 mg/m^2 administered via IV infusion on Day 1, given every 21 days
15808501|NCT04379635|Drug|Pemetrexed Disodium|500 mg/m^2 administered via IV infusion on Day 1, given every 21 days
15808502|NCT04379635|Drug|Placebos|Placebo to match tislelizumab IV infusion
15808503|NCT04379635|Drug|Carboplatin|Area under the curve (AUC) of 5 mg/mL/min administered via IV infusion Day 1, given every 21 days
15808504|NCT04379622|Other|Dietary intake, body composition, lifestyle, and CVD risk factors|Dietary intake, body composition, lifestyle, and CVD risk factors
15808575|NCT04378959|Drug|Lidocaine patch|Up to 3 patches will be applied for 12 hours on (e.g. from 8 AM to 8 PM for those whose pain is worse during the day, or from 8 PM to 8 AM for those whose pain is worse at night) and 12 hours off x 4 weeks.
15809439|NCT04372082|Drug|Hydroxychloroquine|200 mg x 3 per day during 10 days in addition to SOC
15808505|NCT04379609|Other|Masticatory efficiency|"Two-color chewing gum mixing ability test was used to measure masticatory efficiency in the control group, before and after treatment in the experimental group.21 Commercial two-color chewing gum was used.The gum was left on the patient's tongue and he/she was asked to chew 20 times naturally.
~After chewing, the gum was put in a transparent plastic bag and squeezed to 1 mm. Both sides of the sample were scanned at 300 dpi resolution on a desktop scanner (HP Deskjet, California, USA) in the same day to prevent the colors from deteriorating due to saliva. For each patient, two sides of scanned images were processed in ViewGum software (version 1.4, Dhal Software, Kifissia, Greece, www.dhal.com) using the method of Halozenitis et al. (2013).22 The value of VOH (variance of hue) was taken as the value of chewing activity. The highness of this value indicates low masticatory efficiency."
15808513|NCT04379583|Device|HairDx Sample Collection Kit|Saliva collection using FDA OTC cleared sample collection device
15808514|NCT04379570|Other|Educational Intervention|Receive online educational information about ET medication
15808515|NCT04379570|Other|Text Message-based Navigation Intervention|Receive text messages
15808516|NCT04379570|Behavioral|Motivational Interviewing|Receive motivational interviewing counseling sessions
15808517|NCT04379570|Other|Best Practice|Attend usual care clinic visits
15808518|NCT04379570|Other|Questionnaire Administration|Ancillary studies
15808519|NCT04379570|Other|Quality-of-Life Assessment|Ancillary studies
15808520|NCT04379557|Procedure|Catheter Ablation|Catheter Ablation is a procedure used to remove or terminate a faulty electrical pathway from sections of the hearts of those who are prone to developing cardiac arrhythmias
15808521|NCT04379544|Other|Observation only|There is no intervention. This study is purely observational. This study simply follows COVID-19 patients who get CPUS based on their clinician deeming it necessary.
15808522|NCT04379531|Diagnostic Test|Low-dose Chest CT|Patients referred by the primary care physician with suspected pneumonia.
15808523|NCT04379518|Other|Best Practice|Receive standard of care
15808524|NCT04379518|Biological|Recombinant Interferon Alfa-2b|Given IV
15808525|NCT04379518|Drug|Rintatolimod|Given IV
15808526|NCT04379505|Device|Ring gantry kV-CBCT combined with linear accelerator (Halcyon)|-Varian Medical Systems is the manufacturer
15808527|NCT04379505|Radiation|Quad shot radiation|Treatment of each cycle should ideally take place on two consecutive days. Allowing for holidays, weekends, and other scheduling issues or unexpected delays, treatment may be completed within five calendar days.
15808528|NCT04379492|Drug|Hydroxychloroquine|Participants will receive hydroxycholoroquine (200-mg tablets) 2 tablets orally q12h for 2 doses on day 1 (load), followed by 1 tablet orally q12h for days 2-5.
15808529|NCT04379492|Other|Placebo|Participants will receive masked placebo given as 2 tablets orally q12h for 2 doses on day 1, followed by 1 tablet orally q12h for days 2-5.
15808530|NCT04379479|Drug|Dialyzable Leukocyte Extract|Experimental Intervention. Dialyzable Leukocyte Extract
15808531|NCT04379479|Drug|Placebo oral|Placebo
15808532|NCT04379453|Procedure|Robot Assisted Percutaneous Cardiovascular Intervention|Robot Assisted Percutaneous Cardiovascular Intervention
15808533|NCT04379427|Device|Sanmina Biosensor|non-invasive blood glucose measurement using the Sanmina Biosensor referenced with the invasive reference blood glucose device YSI 2400 Plus.
15808534|NCT04379414|Behavioral|YES portal|A web-based portal designed for access by smartphone, tablet, or laptop/desktop. The portal is designed to help monitor cancer related issues and to share self-management information, resources and potential research opportunities. The portal is also designed to create a community among participants through the yeschat.org discussion board.
15808535|NCT04379401|Device|Cardiac Resynchronization Therapy (ON vs. OFF)|This study involves study participants, who already received cardiac resynchronisation therapy implantation for clinical reasons. CRT is authorized for medical use by Swissmedic in Switzerland and all implanted devices are CE-approved.
15808536|NCT04379388|Behavioral|Web + text smoking cessation intervention|Participants will receive referral to a quit smoking hotline and 12-week web and text-based smoking cessation intervention
15808537|NCT04379375|Behavioral|Nudge|Application of behavior-change strategies based on principles of behavioral economics, decision-making heuristics, psychological/environmental variables.
15808538|NCT04379362|Procedure|Focal laser ablation|Focal laser ablation
15808539|NCT04379349|Behavioral|SMS text messaging - interactive check-in|Interactive SMS text message check-ins delivered once weekly to participants.
15808540|NCT04379349|Behavioral|SMS text messaging - inactive control|Minimally interactive SMS text message delivered once weekly to participants.
15808541|NCT04379336|Biological|Bacille Calmette-Guérin (BCG)|BCG vaccine will be given intradermally in the upper arm after randomization.
15808542|NCT04379336|Other|Placebo Comparator|Placebo injection will be given intradermally in the upper arm after randomization.
15808543|NCT04379323|Diagnostic Test|YuWell YE900 Electronic Sphygmomanometer|Measurement blood pressure by YuWell YE900 Electronic Sphygmomanometer and Desk Mercury Sphygmomanometer.
15808544|NCT04379310|Drug|ACE Inhibitors and Calcium Channel Blockers|effect of drugs on patients with covid-19 pneumonia
15808576|NCT04378959|Drug|Placebo patch|Up to 3 patches will be applied for 12 hours on (e.g. from 8 AM to 8 PM for those whose pain is worse during the day, or from 8 PM to 8 AM for those whose pain is worse at night) and 12 hours off x 4 weeks.
15808546|NCT04379271|Drug|IMU-838|"Tablets will be taken BID with a glass of water (if possible); one tablet each in the morning (15 to 50 min before a meal if applicable), and in the evening (2 hours after any meal if applicable).
~If the patient is intubated for ventilation, IMP is to be given via a gastric tube. The tablet has no coating and a homogeneous content and can be crushed into smaller pieces (if necessary) for dosing via gastric tube."
15808547|NCT04379271|Other|Placebo|Matching placebo, twice-daily administration BID as described for the test product, identical number of tablets as given for IMU-838
15808548|NCT04379245|Other|Data research, database analysis|"Extraction of virological data at the virology laboratory (date, SARS-COV2 PCR result, identification number, sex, date of birth) (Excel file)
~Extraction of demographic and viro-immunological data from patients infected with HIV and on PrEP followed at the Hospices Civils de Lyon, France, over the period concerned (Access extraction)
~Data crossing (Excel / Access) and statistical analysis
~Calculation of the positivity rate per calendar period (= number of diagnosed cases / number of patients tested) and the attack rate per calendar period (number of diagnosed cases / number of people exposed (= active file of patients followed reduced by the number already known to be positive))."
15808549|NCT04379232|Biological|Screening test for covid ( RT PCR and CT Chest)|Each patient was screened before surgery with RT PCR and CT Chest. Post operatively, if symptoms, patients are tested with RT PCR and CT Chest
15808550|NCT04379219|Drug|Methotrexate|giving methotrexate at least 1 w week before surgery
15808551|NCT04379206|Diagnostic Test|HIV self-test kit|fingerprick and oral fluid HIV self-tests with optional on-site or hotline staff assistance
15808552|NCT04379193|Behavioral|Neuroproprioceptive facilitation and inhibition physical therapy|All groups underwent two months' therapy, 16 face-to-face sessions (1 hour, twice a week for two months).
15808553|NCT04379180|Drug|Bosentan Tablets|2mg/kg, bid
15808554|NCT04379180|Drug|Sildenafil Tablet|1mg/kg, q6h/q8h
15808555|NCT04379180|Drug|Tadalafil Tablets|1mg/kg, qd
15808556|NCT04379167|Drug|YY-20394|YY-20394 is a selective inhibitor of the delta isoform of phosphatidylinositol 3 kinase (PI3K-δ) which differs structurally from idelalisib, a PI3K-δ inhibitor approved for patients with relapsed chronic lymphocytic leukemia and indolent lymphoma. PI3K-δ signaling pathways are frequently hyperactive in B-cell cancers, making inhibition of PI3K-δ a promising target for B-cell malignancies. YY 20394 has high potency against PI3K-δ, but with markedly improved selectivity in in vitro assays compared to idelalisib. This higher selectivity for PI3K-δ may decrease the risk of serious infection seen with idelalisib and duvelisib (a PI3K-γ/δ dual inhibitor) due to strong immune suppression.
15808557|NCT04379154|Device|Volatile Organic Compounds analysis|Volatile Organic Compounds analysis in exhaled air by electronic noses
15808558|NCT04379128|Other|Attentional tasks|a neuropsychological assessment of attentional task, executive task and interview is proposed to patients or normal control
15808559|NCT04379115|Device|Active Comparator: Active tDCS + Active TUS|"Device: Active comparator device: Active transcranial Direct Current Stimulation (tDCS). Subjects will receive 20 minutes of active tDCS. During each Active stimulation session, stimulation will be applied for the full 20 minutes.
~Device: Active comparator device: Active Transcranial Ultrasound (TUS). Subjects will receive 20 minutes of active Transcranial Ultrasound (TUS). During active stimulation the (TUS) will be active for the full 20 minutes."
15808560|NCT04379115|Device|Sham Comparator: Sham tDCS + Sham TUS|"Device: SHAM Comparator Device: transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of sham tDCS. In the sham group, the tDCS device will not be active for the full 20 minutes.
~Device: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of sham TUS. During sham stimulation the ultrasound will not be active for the full 20 minutes."
15808561|NCT04379102|Other|with NT/TLA (NT or also referred to as therapy with local anesthetics (TLA) )|Patients who visited our family planning clinic and opted for IUD application for contraception purposes were also offered NT/TLA treatments simultaneously. 40 patients who matched the inclusion criteria and received IUDs and NT/TLA treatments were included in the study group and 41 patients who only received IUDs were included in the control group. All patients received copper IUDs and none of them were on additional hormonal treatment. Before the insertion of IUD, women in the therapy group received NT treatment with 6ml of 1% procaine injected transvaginal into the cervix at 5 and 7 o'clock localizations.
15808562|NCT04379089|Other|Observational study only|No Intervention
15808563|NCT04379076|Drug|Interleukin-7|Intramuscular (IM) administration of CYT107 at 3 μg/kg followed, after 48hrs of observation, by 10 μg/kg twice a week for 2 weeks or
15808564|NCT04379076|Drug|Placebos|Intramuscular (IM) placebo (normal saline) at the same frequency
15808565|NCT04379063|Other|COVID-19 pandemic|Currently practicing during the COVID-19 pandemic
15808566|NCT04379050|Drug|ABBV-951|Solution for continuous subcutaneous infusion (CSCI).
15808567|NCT04379037|Device|Transcutaneous Auricular Vagus Nerve Stimulation|Transcutaneous vagus nerve stimulation involves stimulating the auricular branch of the vagus nerve with a imperceptible electrical current within the concha of the ear.
15808569|NCT04379011|Drug|Brivaracetam|Escalating brivaracetam dose to 150 mg twice daily for 3 months
15808570|NCT04379011|Other|Placebo|Placebo twice daily for 3 months
15808571|NCT04378998|Other|Acupuncture|The intervention group received usual care plus acupuncture for three days. The acupuncture spots: Pericardium-6, Stomach-36, Liver-3 and Yin Tang were used. The control group received usual care.
15808572|NCT04378985|Device|Wearing a Wearable device (Fitbit inspire HR)|"'Wearing a wearable device (the smart watch) for 8 weeks
~The smart watch to be used in this study is Fitbit Inspire HR. This is a device that has a high worldwide use rate and has active research on its accuracy. It is worn like a normal watch, and it can check heart rate, exercise level, energy consumed, and sleep quality. The values can be checked in real-time on a smartphone application.'"
15808573|NCT04378972|Other|curcumin, homotaurine, vitamin D3|ELISA tests on supernatants of 25 vitreous biopsies incubated with bioactive molecules at 37 ° C for 20 h. The concentration of soluble mediators was calculated from a calibration curve.
15808574|NCT04378972|Other|control|ELISA tests on supernatants of 25 vitreous biopsies. The concentration of soluble mediators was calculated from a calibration curve.
15808577|NCT04378946|Behavioral|Intensive physical rehabilitation type training|Multiple reaching tasks aiming at increasing voluntary elbow range of motion
15808578|NCT04378946|Device|Robotic system for supporting and monitoring arm motion|"Ergonomic double-joint horizontal manipulandum mounted on a rigid, movable arm (used to support UL movement during tasks).
~An electromyogram (EMG) is used to monitor elbow extensor and flexor muscle activity.
~A motion tracking device based on the Kinect II skeleton ( with Kalman filter to improve accuracy).
~Simple Virtual Reality Reaching Game providing visual feedback with screen display of the subject's arm avatar and arm workspace for the VR training."
15808579|NCT04378946|Device|Actigraph Activity Monitor|Used during and outside training sessions, this device is worned on the affected wrist that records activity (movements metrics) as a measure of upper extremity as well as heart rate
15808580|NCT04378946|Diagnostic Test|Magnetic resonance imaging (MRI)|Done once before treatment (PRE)
15808581|NCT04378946|Diagnostic Test|Montreal Spasticity Measure (MSM)|Used to identify the actual spatial threshold (ST) prior to every training session
15808582|NCT04378933|Device|Amber Glasses|Half of the participants will be wearing the amber glasses to see if they can help with sleep onset.
15808583|NCT04378933|Device|Clear Lens Glasses|Half of the participants will be wearing the clear glasses to see if the glasses help with sleep onset.
15808584|NCT04378920|Drug|LEAF-4L6715|LEAF-4L6715
15808585|NCT04378907|Other|ECIG Lab Session, 30 watts|During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
15808586|NCT04378894|Behavioral|MOCEP|Through parent support and an evidence-based curriculum, MOCEP uses education to reduce risk factors that hinder children's health and wellbeing.
15808587|NCT04378868|Drug|Antibiotics, cefuroxime and metronidazole|Patient receives antibiotics while waiting appendectomy
15808588|NCT04378868|Drug|No antibiotics|No antibiotics are given while waiting surgery.
15808589|NCT04378868|Other|urgent schedule|Patients can wait up to 8 hours for surgery.
15808590|NCT04378868|Other|less urgent schedule|Patients can wait up to 24 hours for surgery.
15808591|NCT04378855|Other|Questionnaire|Quality of life assessment
15808592|NCT04378829|Diagnostic Test|Platelet count, platelet, mean platelet volume and platelet distribution Width in COVID-19|Platelet count, platelet, mean platelet volume and platelet distribution Width in COVID-19
15808593|NCT04378816|Other|Shared decision making support tool|Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions.A question prompt list (QPL) is a structured list of questions that serves as a prompt for patients to consider questions to ask their physician.
15808594|NCT04378803|Behavioral|Mindfulness training (MT) Connect|MT Connect will involve instructor-led weekly sessions and mindfulness exercises over a 4-week interval for a total of 8 to 10 hours. There will be one instructor-led session per week that will last between 2 and 2.5 hours. Participants will also be asked to complete three categories of mindfulness exercises (formal and informal mindfulness exercises, and reflective practices) as part of their daily 'out-of-class' homework. The daily homework will require between 10 to 30 minutes to complete.
15808597|NCT04378777|Procedure|Biological sample collection|During patient hospitalization: Nasal secretion samples by nasal swabs (for non-intubated patients), whole blood (blood draw/phlebotomy) and sputum secretions by endotracheal aspiration (for intubated patients) will be obtained to proceed with immunologic analysis of samples. DNA will be collected from whole blood at enrollment for genetic analysis (e.g., genome-wide association study [GWAS]). After hospital discharge: Collection of biologic samples (involving nasal swabs and blood draw/phlebotomy) will occur up to 12 months.
15808598|NCT04378777|Procedure|Data Collection: Clinical Care Assessments|Baseline data and assessments obtained as part of ongoing clinical care will be collected throughout hospitalization for COVID-19. After hospital discharge, clinical status and activity assessments will occur up to 12 months.
15808601|NCT04378738|Behavioral|survey|all people in the cohort
15808602|NCT04378725|Behavioral|School-based smoking prevention and cessation program (The KOTAK program)|"Advance Intervention: Following the screening process, this intervention package was inclusive of group-briefing for the smokers in at least 3 subsequent sessions in one academic year. The content delivered by the dentist were based on the KOTAK guidebook consisted of 8 Modules.The modules were as follows:
~Introduction: Identifying students who smoke
~Cigarette and addiction
~The danger of smoking and passive smokers
~Advantages of smoke-free lifestyle and adolescent perception on smoking
~Legal and religious perception of smoking
~The benefits of smoking cessation
~Preparation and how to stop smoking
~Nicotine withdrawal symptom and relapse prevention
~The Intervention schools: Screened smokers were given Advanced Intervention sessions. After discussion with the State's oral health deputy director and district's programme coordinator, for the purpose of this study, the interval of the Advance Intervention session was decided at 1-month interval."
15808603|NCT04378712|Device|Hydrogen Oxygen Generator with Nebulizer|Patients in treatment group inhaled H2-O2 (66% hydrogen; 33% oxygen) at 3 L/min via nasal cannula by using the Hydrogen/Oxygen Generator (model AMS-H-03, Shanghai Asclepius Meditech Co., Ltd., China) until discharge.
15808604|NCT04378712|Other|Standard-of-care|Standard-of-care consisted of the supportive therapies (including oxygen therapy) recommended by the Chinese National Health Commission
15808605|NCT04378699|Other|SMR (12-15 Hz)|SMR training sessions (12-15 Hz) C4 unipolar placement, central region
15808606|NCT04378699|Other|alpha band (8 -12Hz)|3 x 10 training sessions of the higher frequencies of the alpha band (8 -12Hz), unipolar placement Fz, fronto-central region
15808607|NCT04378686|Other|dialysis|treatment with dialysis. This can be hemodialysis, hemodiafiltration, peritoneal dialysis
15808608|NCT04378673|Other|not interventional|This randomized controlled trial included data from 120 cases in the pediatric health and diseases department.
15808609|NCT04378660|Diagnostic Test|Artificial intelligence for polyp detection|Colonoscopy enriched with artificial intelligence tool developed for polyp detection, implemented as a second observer
15808610|NCT04378647|Drug|Induction with Brentuximab vedotin (BV)|3 cycles ESHAP plus antibody-drug conjugate brentuximab vedotin (BV) at a dose of 1.8 mg/kg IV
15808611|NCT04378647|Drug|Induction without Brentuximab Vedotin|3 cycles of ESHAP as a standard of care therapy for those patients with primary refractory cHL and those patients relapsing after first-line therapy
15808612|NCT04378647|Drug|Consolidation with Brentuximab Vedotin|Up to 13 or 16 cycles of antibody-drug conjugate brentuximab vedotin (BV) at doses of 1.8 mg/kg iv every 21 days)
15808613|NCT04378634|Behavioral|Exercise|Sub-maximal exercise test
15808614|NCT04378634|Other|Mental Stress Test|Computerised mental arithmetic challenges and social evaluative threat tasks
15808615|NCT04378621|Drug|TNF-α inhibitor OR JAK inhibitor|Pharmacological anti-rheumatic treatment
15808616|NCT04378621|Other|Hand training|Physical hand training 10 min twice daily while on stable treatment
15808617|NCT04378608|Drug|OBV/PTV/r) ± ribavirin (RBV)|
15808618|NCT04378595|Other|During COVID-19 Pandemic|Assessing status of food insecurity during the COVID-19 pandemic
15808619|NCT04378595|Other|After COVID-19 Pandemic|Assessing status of food insecurity after the COVID-19 pandemic
15808620|NCT04378582|Other|risk factors|This is an observational study, so there are no interventions. Investigators will collect data about demographics, comorbidities, and other risk factors such as severity of disease at admission, need for advanced life support, need for invasive mechanical ventilation and ventilator parameters on day1 of mechanical ventilation or ICU admission as potentially association with survival
15808621|NCT04378569|Drug|ARQ-252 cream 0.3%|ARQ-252 cream 0.3%
15808622|NCT04378569|Drug|ARQ-252 cream 0.1%|ARQ-252 cream 0.1%
15808623|NCT04378569|Drug|ARQ-252 Vehicle Cream|ARQ-252 Vehicle Cream
15808624|NCT04378556|Behavioral|Nutritional coaching|Participants were provided with nutrition education and a per-meal protein prescription followed by 9 weeks of nutritional coaching.
15808625|NCT04378543|Biological|ART352-L|recombinant human Wnt3a protein delivered on liposomes to local autologous bone graft during posterolateral fusion procedures
15808626|NCT04378530|Behavioral|Personalized Anchoring Strategy|"The study will run for 8 weeks. Intervention participants will participate in the meditation features in their Calm account. Each participant will receive anchoring specific push notifications related to, tracking sessions completed, reminders, mood symptom tracking, and group-specific goal reminders. The intervention group will be provided an anchoring strategy video on the persistence of daily meditation practice and receive anchoring strategy specific push notification study reminders.
~Participants will be asked to choose a cue to use as an anchoring strategy. Health and well-being measures will be taken at baseline and post-intervention. Participation in the Calm meditations will be tracked (app feature used, time of day used, and time spent in meditation) by the Calm informatics team. Additionally, they will answer one, multiple choice EMA (ecological momentary assessment) question 1x per day (8am, 1pm or 6pm)."
15808627|NCT04378530|Behavioral|Non-Anchoring Strategy Control|The study will run for 8 weeks. Control participants will participate in the meditation features in their Calm account. Each participant will receive non-anchoring specific push notifications related to, tracking sessions completed, reminders, mood symptom tracking, and group-specific goal reminders. The control group will not be provided an anchoring strategy video on the persistence of daily meditation practice and receive non-anchoring strategy specific push notification study reminders. Health and well-being measures will be taken at baseline and post-intervention. Participation in the Calm meditations will be tracked (app feature used, time of day used, and time spent in meditation) by the Calm informatics team. Additionally, they will answer one, multiple-choice EMA (ecological momentary assessment) question 1x per day (8am, 1pm or 6pm).
15808628|NCT04378530|Behavioral|Fixed Anchoring Strategy|The study will run for 8 weeks. Intervention participants will participate in the meditation features in their Calm account. Each participant will receive anchoring specific push notifications related to, tracking sessions completed, reminders, mood symptom tracking, and group-specific goal reminders. The intervention group will be provided an anchoring strategy video on the persistence of daily meditation practice and receive anchoring strategy specific push notification study reminders. Participants will be asked to use a cue given by the research team. Health and well-being measures will be taken at baseline and post-intervention. Participation in the Calm meditations will be tracked (app feature used, time of day used, and time spent in meditation) by the Calm informatics team. Additionally, they will answer one, multiple choice EMA (ecological momentary assessment) question 1x per day (8am, 1pm or 6pm).
15808629|NCT04378517|Other|psychosocial education in parents groups|psychosocial education
15808630|NCT04378517|Other|psychosocial parents support, interviews with APN|Family strength-oriented therapy conversation
15808631|NCT04378491|Other|Collection of clinical measurements|"Collection of clinical measurements:
~Active and passive range of motion (ROM) of the knee, hip and ankle Joint bilaterally.
~Passive patellar translation in 30° of flexion billaterally in quadrants of translation.
~Patellar apprehension test (Fairbank's Test) and the Moving Patellar Apprehension (MPAT) test for the diagnosis of patellar instability. The Fairbank's Test is performed in 30° of Flexion while the MPAT is performed while flexing the knee from 0° to 90°."
15808632|NCT04378491|Other|Collection of data for muscle strength|"Collection of data for muscle strength:
~Muscle strength will be measured bilaterally using a dynamometer (Biodex System 4 Pro: Biodex Medical Systems, Shirley, NY, USA). For the knee, maximum isokinetic Flexion and extension torques will be collected between full extension and full flexion at a movement speed of 60°/s (3 x 5 repetitions) Maximum joint torques in each movement direction will be recorded for each joint and normalized to body weight"
15808633|NCT04378491|Other|Collection of EMG Data|"Collection of EMG Data:
~Surface electrodes will be placed bilaterally on the vastus medialis and lateralis rectus femoris, biceps femoris and semitendinosus muscles following the guidelines of the SENIAM project (Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles). Simultaneously with the muscle strength measurements, EMG data will be collected using a 12-channel EMG system (myon AG, Schwarzenberg, Switzerland, sampling rate 2400 Hz)."
15808634|NCT04378491|Other|Collection of Clinical Scores|"Collection of Clinical Scores:
~patient's pain, range of motion and ability to perform daily living activities will be assessed using the Kujala Anterior Knee Pain Scale, Lysholm Knee Score, visual analog scale score (VAS) and the Tegner Activity Score"
15808635|NCT04378491|Other|Collection of Imaging Data - Radiological measurements|Collection of Imaging Data - Radiological measurements: Xrays and MRIs which were already performed as part of the original diagnostic and follow-up procedures pre- and postoperative will be reviewed and analysed.
15808636|NCT04378465|Other|Enhanced Recovery Program (ERP)|An evidence-based perioperative care approach, involving a multidisciplinary team work including surgeons, anaesthesiologists, dieticians, and nurses, which aim to reduce the surgical stress and metabolic responses as well as organ dysfunction, thus leading to a faster recovery after surgery
15808637|NCT04378452|Behavioral|COM-COVID anonimous survey|Anonimous e-survey administered to the general population by sharing it through social and mass media, including questions on sociodemographic data, physical symptoms in the past 14 days compatible with SARS-CoV-2 infection, socio-economic impact of the COVID-19 outbreak and psychological impact of the COVID-19 outbreak and mental health status.
15808640|NCT04378426|Drug|Nitrous Oxide|PTSD participants in this arm will receive and admixture of up to 50% nitrous oxide and 50% oxygen plus intravenous saline
15808641|NCT04378426|Drug|Midazolam|PTSD participants in this arm will receive and admixture of up to 50%nitrogen and 50% oxygen plus intravenous 0.045mg/kg midazolam
15808642|NCT04378426|Drug|Nitrogen|PTSD participants in this arm will receive and admixture of up to 50%nitrogen and 50% oxygen plus intravenous 0.045mg/kg midazolam
15808643|NCT04378426|Drug|Oxygen|inhaled gas
15808644|NCT04378426|Drug|Saline|Placebo infusion
15808645|NCT04378413|Other|exercise|exercise for low back pain
15808646|NCT04378400|Procedure|Sacrocolpopexy|Sacrocolpopexy is offered to patients with symptomatic prolapse (≥stage II) of the vaginal apex (vault or cervix). The procedure involves dissection of the promontory and the vaginal vault, suturing of two meshes to the anterior and posterior aspect of the vagina using minimally three rows of sutures on each side, and one row at the apex. Thereafter the mesh is fixed with staples to the promontory and the peritoneum closed, with staples and a running suture.
15808647|NCT04378374|Other|Food-1|Baked food made of lentil flour
15808648|NCT04378374|Other|Food-2|Baked food made of lentil flour and wheat flour
15808649|NCT04378374|Other|Food-3|Baked food made of wheat flour
15808650|NCT04378374|Other|Food-4|Potable water (energy and carbohydrate-free control)
15808651|NCT04378361|Device|endovascular repair|Endovascular repair of complicated acute, subacute or chronic type B aortic dissection with double lumen
15808652|NCT04378348|Behavioral|Motivational Interview (MI)|The MI dialogue will begin with an introduction where the LDL is asked about the type of work he does and his concerns regarding dangers in his workplace. This will be followed by a decisional balance exercise where the interviewer will engage the LDL in thinking about the pros and cons of taking jobs with many dangers and jobs with less dangers. Using a figure of a traffic light, the interviewer will proceed to measure how important it is for the LDL to reduce the dangers in his work place and identify his reasons for its importance. Next, the interviewer will measure the LDL's level of confidence in his ability to reduce the dangers in his workplace.Together, they will develop a plan to reduce the dangers in the workplace. Finally, the interviewer will summarize the safety plan to the LDL and will explain that the team will return to the corner in one month to see how the implementation of his plan went and to conduct a post-test survey
15808653|NCT04378348|Behavioral|Participatory Group Activity|Participants will view a figure of a pyramid representing the steps they can take to reduce the dangers in their workplace and the things that are in their control to reduce the dangers followed by pictures of dangerous work environments. They will be engaged in hazard identification and situational awareness by identifying and sharing out loud the dangers they see in the picture. Participants will also engage in problem solving by coming up with strategies they could use to reduce the dangers they identified in the picture and will measure their level of confidence in their ability to implement the strategies they have come up with, should they find themselves in a similar work situation. The group facilitator will summarize what the group has said and what they have learned during the group activity and will ask participants to voluntarily make a personal promise to take concrete steps to reduce the dangers at their work.
15808654|NCT04378348|Behavioral|Control Condition|At control corner sites, we will recruit another 35 Latino day laborer participants.Participants in the control group will receive OSHA pamphlets with standard workplace safety and health information. During our needs assessment survey, we collected information regarding workrelated injuries. Results from this survey indicate the following 4 categories are the highest cause of injury among surveyed Latino day laborers: 1) moving heavy objects, 2) falls, 3) being struck by falling or lying objects, and 4) serious cuts. The OSHA materials that will be distributed to participants will include safety and health information regarding these four topics. Furthermore, given that the LDL are continuously exposed to the sun (e.g., at the corner while waiting for work, at work, and on their way to and from work), heat exposure will also be included in the OSHA materials.
15808655|NCT04378335|Other|completion of questionnaire|parents have to complete 2 questionnaires: demographic questionnaire and Montréal questionnaire when they come on allergy consultation.
15808656|NCT04378322|Behavioral|Nutrition and food purchasing tool + telenutrition|Participants will be asked to use a meal planning and food purchasing feature regularly (at least once every two weeks) and schedule appointments with a registered dietitian.
15808756|NCT04377516|Other|education of pelvic girdle|education of pelvic girdle
15808657|NCT04378322|Behavioral|Nutrition and food purchasing tool|Participants will be asked to use a meal planning and food purchasing feature regularly (at least once every two weeks).
15808658|NCT04378322|Behavioral|Nutrition education tool|Participants will be asked to review nutrition education materials online.
15808659|NCT04378309|Behavioral|ePREP|6-session online psychoeducational program with supporting coach calls
15808660|NCT04378296|Other|Teledermatology|The experimental group will be made up of dermatological patients monitored asynchronously.
15808661|NCT04378283|Drug|LET gel (lidocaine 4%, epinephrine 0.1%, and tetracaine 0.5%)|The study is designed to evaluate topical anesthetics
15808662|NCT04378283|Drug|EMLA plus infiltration as anesthetic for wound repair.|EMLA plus infiltration as anesthetic for wound repair.
15808663|NCT04378270|Device|PopSole™ Offloading Device|Specifically, the PopSole™ Offloading Device allows the provider to pop bubbles in the device (like popping paper or plastic bubble sheeting), thereby offloading the surgical area or area of pain. This customizable approach to offloading may increase compliance as it can easily fit in a normal walking shoe and is personalized for each patient. It can also be attached to a slide for use in the shower. Currently no post-operative devices for offloading the foot can be used in the shower.
15808664|NCT04378257|Behavioral|Therapist Guided E-Therapy|"The participants in this group will be allocated weekly sessions with a trained aboard certified clinical psychologist via a web-based e-therapy platform.The link will direct the participant directly to a screen where they will be able to see and interact with the psychologist once a week. The sessions will be conducted in the Arabic or English languages.Following sessions would focus on psychological first aid based on the following interventional tools:
~Cognitive Behavior Therapy (CBT)
~Acknowledging emotions and normalizing current stress
~Differentiate dysfunction versus distress (identify any debilitating thoughts/emotions if applicable)
~Behavioral Activation Acceptance and Commitment Therapy (ACT)
~Grounding, Breathing, Acceptance of emotions, and de-fusion"
15808665|NCT04378257|Behavioral|Self-Help Therapy|The participants in the control group will be supplied with an automatic weekly newsletter through E-mail containing self-help information and tips to cope with distress associated with COVID-19 in Oman. The information will mainly comprise of behavioral tips from principles of CBT and ACT focusing on positive cognitive reinforcement, strengthening relationships and mindfulness practice. The participants will be requested to use this information to manage any distress that they might experience. On the sixth week, the participants in the control group will be assessed on their mood and anxiety symptoms. Participants will also be requested to provide information on other self-help remedies that participants used to improve or manage their functionality (example, access to other websites, communication with close friends or family etc.)
15808666|NCT04378244|Drug|DeltaRex-G|"This is an open label, dose-seeking phase 1/2 study using escalating doses of DeltaRex-G given intravenously for 7 days in a hospital setting.
~The study will employ the standard Cohort of Three design (Storer, 1989). Three patients are treated at each dose level with expansion to six patients per cohort if DLT is observed in one of the three initially-enrolled patients at each dose level. If no DLT occurs in 3 patients, escalation to the next dose level will be permitted. The maximum tolerated dose is defined as the highest safely tolerated dose, where not more than one patient experienced DLT, with the next higher dose level having at least two patients who experienced DLT. No intra-patient dose escalation will take place. Patients who do not complete the 7-day treatment will be replaced."
15808667|NCT04378231|Drug|Amoxicillin-Clavulanate 200 Mg-28.5 Mg Oral dry suspension|dry suspension of amoxicillin clavulanate potassium
15808668|NCT04378218|Behavioral|High Intensity Interval Training (HIIT)|A 16 week, 3 sessions per week HIIT program from the subject's personal wheelchair, positioned near an adjustable table with an arm-ergometer affixed.
15808669|NCT04378205|Procedure|0.014-inch NiTi on one side /0.018-inch NiTi on the other side|Where each patient received 2 archwire sizes (0.014-inch and 0.018-inch) at one time joined in the midline by crimpable hook and applied in the lower arch.
15808670|NCT04378205|Procedure|0.016-inch NiTi on one side /0.018-inch NiTi on the other side|Where each patient received 2 archwire sizes (0.016-inch and 0.018-inch) at one time joined in the midline by crimpable hook and applied in the lower arch.
15808671|NCT04378192|Device|Laryngeal mask airway|Insertion of laryngeal mask airway before intubation of a morbidly obese patient
15808672|NCT04378192|Device|face mask|use of face mask before intubation of a morbidly obese patient
15808673|NCT04378166|Device|Smart glass|Practitioner wears smart glasses connected to ultrasound machine during central venous catheterization
15808678|NCT04378140|Other|zirconia wing bridge|The zirconia wing bridge consists of an artificial tooth made out of zirconia and porcelain on the front side with two zirconia wings that are bonded (glued) onto the back of the two adjacent teeth in the patient's mouth.
15808679|NCT04378127|Other|Educational program|The educational program consisted of six thematic meetings of 3 hours each, which a 15-minute interval every hour. Each meeting had a key topic and was divided in a teaching session and in a practical session with individual training of both, subject and caregiver. Every lecture was held by a movement disorders specialist with particular expertise in each field of discussion and the content of each lessons (slides, flyers, questionnaires) was adapted to fit the audience.
15808680|NCT04378114|Device|Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. C sensor algorithm applied retrospectively to raw sensor data.|Characterize the impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) when C sensor algorithm is used.
15809474|NCT04371718|Other|Placebo|A capsule has same component but active drug
15808681|NCT04378114|Device|Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter. Zeus sensor algorithm applied retrospectively to raw sensor data.|Characterize the impact of acetaminophen ingestion on the accuracy of Guardian™ Sensor (3) when Zeus sensor algorithm is used.
15808682|NCT04378114|Drug|Acetominophen|One time administration of acetaminophen.
15808683|NCT04378101|Other|Eating disorder diagnosis group|This is an observational study, no active intervention is applied. Participants are assigned to an eating disorder diagnosis group based on their lifetime history of disordered eating behaviors and symptoms.
15808684|NCT04378088|Other|Validation of CEBuS|Validation of a new score for bubbles in the colon.
15808685|NCT04378075|Drug|Vatiquinone|Vatiquinone will be administered per the treatment arm description.
15808686|NCT04378075|Other|Placebo|Vatiquinone-matching placebo will be administered per the treatment arm description
15808687|NCT04378062|Procedure|Digital nerve procedure|The type of procedure performed on the digital nerve at the time of amputation
15808688|NCT04378049|Procedure|Total knee arthroplasty|Surgeon will perform a total knee arthroplasty procedure according to local standard of care
15808689|NCT04378049|Procedure|Robot-assisted partial knee arthroplasty|Surgeon will perform a robot-assisted unicompartmental or bicompartmental knee arthroplasty procedure
15808690|NCT04378036|Other|Neurodevelopmental Therapy|The Neurodevelopmental Therapy rehabilitation program was determined according to the children's level of gross motor function, age, gender, mental state, and preferences. Neurodevelopmental Therapy program consists of the rehabilitation of muscle tone disorders, increasing sensory-perception-motor integrity, exercises to increase limb functions and body control, stretching and strengthening exercises for muscle shortness and weakness, exercises that include movements in daily life and training activities such as standing, walking, body care.
15808691|NCT04378036|Device|Hippotherapy Simulator|Horse Riding Simulator (HRS) device was used as a hippotherapy simulator device. HRS is a device that moves forward, backward, backward-to-back, right-to-left swing and up-and-down swing in 3 dimensions, similar to the movements of a real horse, forming an 8-shaped movement on five axes. After the children sat in the saddle section, they were first taken to the warm-up speed program for 5 minutes, then to another one of the other speed levels (gradually moved to other speed levels as appropriate for the development and tolerance of children) and finally to the warm-up speed program for 5 minutes.
15808692|NCT04378023|Drug|Neoadjuvant Chemo-radiotherapy|Patients will receive neoadjuvant radiotherapy (External - 50-54 grays) following by concomitant oral capecitabine (825mg/m2 bid).Thereafter, gemcitabine iv (1000mg/m2) plus cisplatin iv (25mg/m2) will be administered the day 1 and 8 every 21 days until transplant.
15808693|NCT04378023|Procedure|Liver Transplantation|If no spread disease is discovered after neoadjuvant treatment, the patient will be listed for liver transplantation.
15808694|NCT04378010|Drug|EDP-305 1.5 mg|Tablet
15808695|NCT04378010|Drug|EDP-305 2 mg|Tablet
15808696|NCT04378010|Drug|Placebo|Tablet
15808697|NCT04377997|Drug|Enoxaparin|Given the established link between endothelial dysfunction and thrombosis in patients with cardiovascular disease9, 10 and the association between coagulopathy and adverse outcomes in patients with sepsis11, the association between increased coagulation activity, end-organ injury, and mortality risk may represent a modifiable risk factor among COVID-19 patients with critical illness. Therefore, we propose to conduct a randomized, open-label trial of therapeutic anticoagulation in COVID-19 patients with an elevated D-dimer to evaluate the efficacy. Most patients will receive low molecular weight heparin however, unfractionated heparin (UFH) will be administered for those with morbid obesity or moderate to severe renal dysfunction.
15808698|NCT04377971|Behavioral|SOC education|Standard participant education from researcher
15808699|NCT04377971|Behavioral|Ask-tell-ask education|Participant education using the ask-tell-ask method. First the researcher will ask a question about participant understanding of wound care and after hearing the participant's answer, the researcher will then proceed to tell the patient how to best take care of their wound using a standardized script. After the educational portion, the researcher will then ask the patient to repeat the information that was shared. If the participant's answer is wrong or incomplete, the researcher will then explain the instructions again to ensure that the participant understands the steps needed.
15808700|NCT04377971|Other|Participant satisfaction survey|Participant satisfaction survey using components of the 16 item Skindex questionnaire and the 18 item version Patient Satisfaction Survey, adapted for treatment of skin cancer to characterize patient experience administered at two weeks post-operatively in person
15808701|NCT04377971|Other|Wound care adherence survey|Wound care adherence survey administered at one week over the phone and at two weeks in person
15808702|NCT04377958|Diagnostic Test|Serum biomarker testing|Serum and sputum samples will be collected and biomarkers will be evaluated using ELISA
15808703|NCT04377945|Drug|Part 1, JM-010 component Group A|JM-010 component Group A
15808704|NCT04377945|Drug|Part 1, JM-010 component Group B|JM-010 component Group B
15808705|NCT04377945|Drug|Part 1, JM-010 component Group C|JM-010 component Group C
15808706|NCT04377945|Drug|Part 1, Placebo Group|Placebo Group
15808707|NCT04377945|Drug|Part 2, JM-010 combination Group A|JM-010 combination Group A
15808708|NCT04377945|Drug|Part 2, JM-010 combination Group B|JM-010 combination Group B
15808709|NCT04377945|Drug|Part 2, JM-010 component Group C|JM-010 component Group C
15808710|NCT04377945|Drug|Part 2, Placebo Group|Placebo Group
15808714|NCT04377919|Dietary Supplement|Cranberry|The patients will receive 2 capsules per day containing 500mg of cranberry extract for 8 weeks
15808715|NCT04377919|Dietary Supplement|Placebo|The patients will receive 2 capsules per day containing 500mg of maize starch for 8 weeks
15808716|NCT04377906|Behavioral|Modification Lifesyle|high protein-fiber and exercise
15808717|NCT04377893|Device|Eye gaze AT intervention|"The eye-gaze AT intervention includes eye-gaze AT and service delivery to support the participants using this technology in daily life. The Tobii PCEye Mini (Tobii, Danderyd, Sweden) and specialized software are applied with adaptation to meet each child's individual needs.
~To ensure the consistency of service delivery, two-day courses are conducted before the intervention. The participant's teachers or parents are invited as the main interventionist to facilitate the child's usage of eye-gaze AT in daily life under team support. The service delivery involves parents in joint goal-setting, planning, and jointly review the progress of the usage of eye-gaze AT as a family-centered practice. Individual meetings and individual supports are provided during intervention periods. The collaborative team will perform biweekly follow-up contacts during intervention periods.
~The researcher will conduct the fidelity checklist every month to determine the extent of treatment integrity."
15808718|NCT04377152|Drug|68Gallium-PSMA-11|PSMA-11 Ga 68 Injection is a positron emitting radiopharmaceutical containing radioactive 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC (PSMA-11), which is used for diagnostic purposes in conjunction with Positron Emission Tomography (PET).
15808719|NCT04377152|Procedure|Positron Emission Tomography (PET)|A PET scan is an imaging test that helps reveal how your tissues and organs are functioning using a radioactive drug (tracer) to show this activity
15808720|NCT04377867|Drug|Abatacept Injection [Orencia]|Patients on abatacept to control disease symptoms
15808721|NCT04377854|Other|Observation. No intervention per se.|Observation. No intervention (no collection of blood).
15808722|NCT04377854|Other|2) Observation and collection and of blood sample|All patients evaluated for adv HF (HTX/LVAD) will be offered to contribute to this database; Blood samples will be collected from all at baseline. Patients receiving LVAD will contribute on a yearly basis (or until withdrawal of consent). For other patients no further blood will be collected unless they receive an LVAD at a later point.
15808723|NCT04377828|Device|Pigment laser|one to two session of pigment laser (532 nm)
15808724|NCT04377815|Other|General Public cohort|No intervention is being tested
15808725|NCT04377802|Diagnostic Test|molecular testing for virus RNA using RT-PCR|Serological testing will be performed using SARS-CoV-2 IgG assay kit (Abbott Diagnostics, US) to check for the immunity. The IgG serology test (200 individuals per run) will be done using ARCHITECT i2000SR system which provides the results within 60 minutes
15808726|NCT04377789|Dietary Supplement|Quercetin Prophylaxis|a daily dose of quercetin (500mg) will be taken by non-COVID-19 intervention group 1
15808727|NCT04377789|Dietary Supplement|Quercetin Treatment|a daily dose of quercetin (1000mg) will be taken by proven COVID-19 cases intervention group 2
15808728|NCT04377776|Other|Practice details|Questionnaire
15808729|NCT04377750|Drug|Tocilizumab|The placebo treatment arm will include 100 ml of normal saline administered along 60 min
15808730|NCT04377737|Diagnostic Test|RT-PCR Covid-19|estimation of the prevalence of positive rt-PCR in school children during the pandemic period
15808731|NCT04377711|Drug|Ciclesonide|160mcg Inhaler
15808732|NCT04377711|Drug|Placebo|Matching Placebo Inhaler
15808733|NCT04377698|Biological|Platelet Rich Fibrin|regeneration, restoration or reconstitution of the lost periapical tissues of the tooth by using regenerative therapies that utilize growth factors and barrier membranes.
15808734|NCT04377698|Biological|FDBA|regeneration, restoration or reconstitution of the lost periapical tissues of the tooth by using regenerative therapies that utilize growth factors and barrier membranes.
15808735|NCT04377685|Other|CT-Scan|Chest CT scan on admission to the hospital
15808736|NCT04377672|Biological|Anti-SARS-CoV-2 Human Convalescent Plasma|"1-2 unit (200-250 mL per unit) of plasma with anti-SARS-CoV-19 titers of ≥1:320.
~The total volume (mL) infused will be based on weight (5 mL/kg) with a maximum volume of 500 mL."
15808737|NCT04377659|Drug|Tocilizumab|Participants will receive Tocilizumab 8 mg/kg i.v. at enrollment. Dose will be capped at 800 mg per infusion. If there is no improvement or toxicity, a second dose can be given 24 hrs to 5 days later.
15808738|NCT04377646|Drug|Hydroxychloroquine|400 mg at day 1 and day 2, then 400 mg weekly up to 2 months
15808739|NCT04377646|Drug|Hydroxychloroquine (placebo)|1 pill at day 1 and day 2, then 1 pill weekly up to 2 months
15808740|NCT04377646|Drug|Zinc|15 mg per day up to 2 months
15808741|NCT04377646|Drug|Zinc (Placebo)|1 pill per day up to 2 months
15808742|NCT04377633|Procedure|Oral handover|Anesthesia handover during surgery will be performed as usual, i.e., oral exchange of pertinent clinical information.
15808743|NCT04377633|Procedure|Checklist handover|Anesthesia handover during surgery will be performed according to a structured handover checklist.
15808744|NCT04377620|Drug|Placebo|Placebo administered BID approximately 12 hours apart
15808745|NCT04377620|Drug|Ruxolitinib|Ruxolitinb administered BID approximately 12 hours apart
15808746|NCT04377607|Other|File scanning|RBC, HGB, HCT, MCH, MCV, MCHC, WBC values will be noted in the hemogram test performed at the time of initial admission
15808747|NCT04377594|Procedure|Radio frequency ablation|Two different radio frequency ablation procedures
15808748|NCT04377568|Biological|Convalescent plasma (CP)|Participants will receive one infusion of convalescent plasma proportional to their weight (10 mL/kg), up to a maximum of 500 mL
15808749|NCT04377555|Drug|Ocrelizumab|Ocrelizumab will be administered intravenously (IV) at a dose of 600 mg every 24 weeks. The first dose of ocrelizumab will be administered as two 300 mg IV infusions given 14 days apart. For the subsequent dose, ocrelizumab will be administered as a single 600 mg IV infusion every 24 weeks.
15808750|NCT04377542|Procedure|LIFT|Ligation of the fistula tract in the intersphincteric plane
15808751|NCT04377542|Procedure|Parks|Modified Parks fistulotomy with complete internal anal sphincterotomy
15808752|NCT04377542|Procedure|Seton|Excision of the superficial part of fistula tract and tying loose seton around the remaining part and anal sphincter muscles
15808753|NCT04377529|Behavioral|Local Champion|Local champions (physiotherapists) will co-develop the champion training support based on a comprehensive behavioural analysis, previous implementation work and evidence-based theory. The study team will provide this training and support to the champions, who will then provide additional support to their peers participating in the study.
15808754|NCT04377516|Other|pelvic floor muscle training|pelvic floor muscle training
15808755|NCT04377516|Other|pelvic floor muscle combined global muscle exercise training|pelvic floor muscle combined global muscle exercise training
15808757|NCT04377503|Drug|Tocilizumab 180 MG/ML|Tocilizumab 8 mg/kg diluted in 100 ml of saline administered in 60 minutes. The dose will be repeated after 12 hours.
15808758|NCT04377503|Drug|Methylprednisolone Sodium Succinate|Patients will receive methylprednisolone at a dose of 1.5 mg / kg / day divided into 2 daily doses for 7 days. Then they will receive 1 mg / kg / day for another 7 days. Finally 0.5 mg / kg / day until 21 days of use
15808759|NCT04377490|Other|venous ultrasound|Venous ultrasound will be performed on patients once a week, every week from the day of admission in Amiens Hospital until the day of patient discharge
15808760|NCT04377490|Biological|blood sample|blood sample for coagulation and hemostasis analysis will be withdrawn from artery catheter from the day of admission in Amiens Hospital until the day of patient discharge
15808761|NCT04377477|Radiation|Single fraction whole lung radiotherapy|Participants will undergo irradiation of the lungs, administered in a single fraction at the average prescription dose of 0.7 Gy
15808762|NCT04377464|Other|SF12, EQ-5D-5L and work status standardized quantitative assessments|Quality of life assessments
15808763|NCT04377451|Drug|Metformin|"The trial will be conducted in two phases, with a dose escalation of metformin. Metformin dosing will begin at 500mg (children) and 850mg (adults) once daily for 5 days in cohort 1.
~Cohort 2 will be received weight-based doses; 5 days of 1000mg (500mg twice daily) for those weighing <60kg and 5 days of 1500mg (1000mg mane, 500mg nocte) for those weighing ≥60kg"
15808764|NCT04377425|Diagnostic Test|COVID-19 swap test PCR|COVID-19 swap test PCR performed according to hospital standard operating procedures
15808765|NCT04377412|Other|Pandemic control measures|Population of different countries are exposed to different pandemic control measures, and everyday lives of pregnant women are affected on different levels. Investigators will measure influence their influence on mental health.
15808766|NCT04377399|Drug|Vitamin D|Patients will be randomised to receive either high dose vitamin D (40,000 IU weekly) or low dose vitamin D (5,000 IU weekly) for 24 weeks
15808767|NCT04377386|Dietary Supplement|1000 IU D vitamin|Participants in the intervention group will receive 105 DV doses of 1000 IU. The supplementation will be given by the Farma de Colombia laboratory, known commercially as Farma D, whose presentation is in soft gelatin capsules. It is recommended to take one dose per day at the same time and participants should record the daily intake time of the supplement for 15 weeks on a calendar.
15808768|NCT04377386|Dietary Supplement|200 IU D vitamin|Participants in the control group will receive 105 DV doses of 200 IU. The supplementation will be given by the same laboratory; it will have the same characteristics and recommendations for the intake as for the intervention group.
15808769|NCT04377360|Radiation|Diffusing Alpha-emitter Radiation Therapy|Diffusing Alpha-emitter Radiation Therapy (DaRT) is a method of delivering interstitial brachytherapy, based on the interstitial intratumoral placement of an encapsulated Radium-224 source (3.7 days half-life). These sources release short-lived alpha-emitting atoms into the tumor microenvironment by recoil. As the radioisotope has a short half-life, the majority of radiation absorption happens in the tumor.
15808770|NCT04377347|Other|Time|Exposure is the time from patients call the Emergency Medical Coordination Center to they are admitted to a neurosurgiocal department.
15808771|NCT04377334|Biological|MSC|infusion of allogeneic bone marrow-derived human mesenchymal stem (stromal) cells
15808772|NCT04377321|Drug|Colchicine Tablets|colchicine tabletes for 6 months
15808773|NCT04377308|Drug|Fluoxetine|Fluoxetine 20 mg to 60 mg daily given from 2 weeks to 2 months duration
15808774|NCT04377295|Drug|Ranibizumab 0.5Mg/0.05Ml Oph Inj|All patients received one monthly intravitreal injection of Ranibizumab (0.5 mg/0.05 ml) through the pars plana under aseptic conditions until maximum visual acuity was achieved and there was no sign of macular edema at optical coherence tomography
15808775|NCT04377282|Other|Food-1|Cooked buckwheat
15808776|NCT04377282|Other|Food-2|Cooked couscous
15808777|NCT04377282|Other|Food-3|Water
15808778|NCT04377269|Other|Taping and Bandaging|Ankle taping: a hard preventive Zinc oxide tape was used. The taping procedures consisted of three separate steps. 1) included the application of the anchor tape. 2) application of the stirrup tape. The stirrup tape was performed two times by holding the foot in a neutral position and the tape is placed as it passed through the medial side of the ankle (under the foot), just over the heel area (posterior one-third of the foot) and up along the lateral side of the ankle. Bandaging: standard 10cm width elastic bandage used. The bandage wrapped around the ankle joint in the form of an 8-figure. Bandage started from the forefoot, moving diagonally upwards and steeply enough to go well above the heel to end around the lower calf area to form an anchor. Then, it moved diagonally down across the mid-foot. Placebo: 10cm long tape was applied on the lateral side of the leg, just above the lateral malleolus and aligned with peroneus longus tendon
15808779|NCT04377256|Procedure|Ridge preservation: Tooth extration and immediat bone grafting in the socket|Following the tooth extraction, the socket is filled with a mixture of xenogenic bone and hyaluronic acid and sealed with an epithelio-connective arrested from the maxillary palate
15808780|NCT04377243|Biological|V8|one pill per day either V8 or placebo
15808781|NCT04377230|Procedure|biliopancreatic limb length of 60cm.|Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 60cm.
15808782|NCT04377230|Procedure|biliopancreatic limb length of 100cm.|Roux-en- Y gastric bypass will be performed with a biliopancreatic limb length of 100cm.
15808783|NCT04377217|Other|Video recording|The experimenter will make a standardized video of the patient during the inclusion process, and a second one after 18 months, in order to evaluate the evolution of facial damage. Then algorithms will be developped to be able of differentiating FSHMD patients with facial damage from control subjects using video and audio recordings.
15808784|NCT04377204|Drug|marcaine bupivacaine|This drug is already FDA approved and used for the indication as a local anesthetic. The study herein would like to examine the pain outcomes of enrolled patients who will either have lidocaine alone OR lidocaine+bupivacaine combination locally prior to rhinoplasty surgery.
15808785|NCT04377204|Drug|Lidocaine|This drug is already FDA approved and used for the indication as a local anesthetic. The study herein would like to examine the pain outcomes of enrolled patients who will either have lidocaine alone OR lidocaine+bupivacaine combination locally prior to rhinoplasty surgery.
15808811|NCT04376957|Behavioral|Standard of care consisting of standard counselling|Consists of instructions and information on the regimen, common side effects, symptom management, medication safety and how to contact a clinician for any problems encountered.
15808786|NCT04377191|Other|exergame|Microsoft Xbox 360 Kinect The exercises were advanced from simple to complex. The program started with exercises in a sitting position. In the next stage, the games requiring weight transfer and use of upper limbs in standing position were continued. The program ended with games that require more complex movements such as lunge and mini squats.
15808787|NCT04377191|Other|exergame|ALDA In the training, games that could be controlled by balance swing, trunk movements and weight transfer in sitting or standing position were used.
15808788|NCT04377191|Other|exercise|Standard Exercise Program The program included warm-up, main exercise and cooling. Warm-up and cooling included neck, trunk, upper-lower extremity range of movement (ROM) exercises and stretching exercises. Main exercise included postural alignment, strengthening for trunk and lower extremity, balance and walking exercises.
15808789|NCT04377178|Device|Dentin grinder|After atraumatic extraction of the tooth, autogenous dentin particles are made with the help of a device - dentin grinder from the separated root and these particles are incorporated into the extraction socket
15808790|NCT04377178|Device|Bone mill|After atraumatic extraction of the tooth, autogenous dentin particles are made with the help of a device - Bone mill from the separated root and these particles are incorporated into the extraction socket
15808791|NCT04377165|Behavioral|Gamification|This will provide the user with the newsfeed function and the addition of a gamification function
15808792|NCT04377165|Behavioral|Newsfeed function|This will provide the user with reliable accurate information on the pandemic.
15808793|NCT04377139|Procedure|Prophylaxis|The intervention consists of analyzing the differences in the evolution of lung transplant recipients in relation to the intervention of prophylaxis or preemptive therapy against CMV in LTR
15808794|NCT04377139|Procedure|Preemptive|The intervention consists of analyzing the differences in the evolution of lung transplant recipients in relation to the intervention of prophylaxis or preemptive therapy against CMV in LTR
15808795|NCT04377126|Drug|Ghrelin|Ghrelin is a peptide and hormone that is primarily produced by P/D1 cells of the gastric fundus and circulates in both acylated and unacylated forms. This pilot trial will gather preliminary evidence to test investigators hypothesis that unacylated ghrelin improves walking performance and prevents mobility loss in older patients with PAD.
15808796|NCT04377126|Drug|Placebo|Placebo will consist of saline- no active ingredient.
15808798|NCT04377087|Drug|Olaparib|Olaparib is a potent oral poly (ADP-ribose) polymerase (PARP) inhibitor that induces synthetic lethality in BRCA1/2 deficient tumor cells through the formation of double-stranded DNA breaks which cannot be accurately repaired, which leads to disruption of cellular homeostasis and cell death.
15808799|NCT04377061|Diagnostic Test|Evaluation of anemia|Evaluation of anemia in NCWS patients, and in CD and IBS controls, with both retrospective and prospective method.
15808800|NCT04377048|Drug|Nivolumab|"as described in NGS Arm"
15808801|NCT04377048|Drug|Gemcitabine|"as described in NGS Arm"
15808802|NCT04377048|Drug|Tegafur-Gimeracil-Oteracil|"as described in NGS Arm"
15808803|NCT04377022|Other|Combined Therapy (Aerobic Exercise in addition to conventional therapy)|"There are two intervention arm in the study
~Combined therapy
~Conventional Therapy"
15808804|NCT04377009|Device|Sleep Healthy Using the Internet (SHUTi)|Cognitive behavioral therapy delivered via internet-guided program customized for military service members
15808805|NCT04377009|Other|Education Control Program|Online portal designed to inform participants about healthy lifestyle activities and general insomnia information
15808806|NCT04376996|Diagnostic Test|NO intervention planned due to the observational study design - only a diagnostic testing|Only a diagnostic tests are planned: SARS-CoV-2 RNA in nasopharyngeal samples and anti-SARS-CoV-2 antibodies in blood
15808807|NCT04376983|Behavioral|Telerehabilitation for patients with a cardiac resynchronisation device|Using the device-measured physical activity to create tailored motivational messages and tips to the patients to increase physical activity
15808808|NCT04376970|Drug|FLUCON®|"The drug was prescribed monthly according to the predefined regimen. It was not namely specefied in the prescription and was delivered by the hospital pharmacy according to the randomisation list.The subjects were masked to the contents and were instructed to return the empty tubes on monthly visit, wherein 1 pack of topical treatment was provided to them. Neither the patient nor the ophthalmologist knew the allocated treatment. No other medication was allowed during the trial. Duration of the whole regimen was six months. The study included an extra month after the end of the regimen. It was called  wash-out . Patients who had less than one month of treatment or an uncontrolled treatment side effect or who presented a degenerative iron line were excluded from the rest of the regimen."
15808809|NCT04376970|Drug|Cyclosporine A eye drops 0.5%|The same regimen was prescribed for both treatments in order to preserve the double-blind characteristic. Cyclosporine eye drops 0.5%, was prepared from an oral solution of cyclosporine (Sandimmun®) and combined with castor oil, both sterilized by filtration. The preparation was carried out in a pharmacotechnical laboratory where a controlled atmosphere area was dedicated to ophthalmic preparations. The castor oil-Sandimmun® solution mixture is made in a sterile receptacle. After stirring, the mixture is distributed into sterile low density polyethylene bottles. A sterile insert and cap including a tamper-evident seal were placed on each bottle. A content control was then carried out on each batch produced. A sterility test was done on a batch of each day of preparation. Each bottle of each batch is then cleaned, polished, labeled and then packaged in a pre-printed box with an adapted notice. The stability was fixed at 6 months before opening and at 15 days after opening.
15808810|NCT04376957|Behavioral|Multinational Association of Supportive Care in Cancer Oral agent Teaching Tool|"This tool was developed by an expert panel of oncology nurses and was further revised following external review of health care providers world-wide. This tools involves four key modules 1) patient's baseline knowledge, 2) patient education of oral cancer drugs 4) patient education tailored to a specific cancer drug 4) evaluation of the educational material.
~It was originally studied in 30 patients with lung cancer and was shown to be feasible with acceptable knowledge retention. Similarly, in a single center cohort study of general oncology patients, medication adherence self-efficacy appeared to improve with MOATT. The MOATT interventional tool incorporates key components of patient education and also has the advantage of being a potentially feasible tool that can be incorporated into future routine clinical practise."
15808813|NCT04376931|Drug|Intravenous Solution|Iscador®P: fermented aqueous extract of mistletoe grown on pine tree (Viscum album L. subspecies austriacum (Wiesb.) Vollmann), licensed for subcutaneous (SC) application in Switzerland, Germany, Austria, Sweden, and South Korea in dosages up to 20 mg.
15808814|NCT04376918|Device|Begin with BVGA|"Device: BVGA The BVGA enables the direct connection of a bag valve device to a Guedel, eliminating the need for a face mask during ventilation
~Other Names:
~• Bag Valve Guedel Adaptor Device: Face Mask Classic face mask"
15808815|NCT04376918|Device|Begin with Face-mask|"Device: BVGA The BVGA enables the direct connection of a bag valve device to a Guedel, eliminating the need for a face mask during ventilation
~Other Names:
~• Bag Valve Guedel Adaptor Device: Face Mask Classic face mask"
15808816|NCT04376892|Other|Quality of life measurement|Quality of life measurement by St. George Respiratory questionnaire
15808817|NCT04376879|Other|Data monitoring for 48h within the first 24 hours of admission for COVID-19|The admission variables and those constituting the predictive score (blood pressure, temperature, oxygenotherapy, biological analysis...) will be collected for 48 hours after enrolment (i.e within the first 24 hours of admission )
15808818|NCT04376866|Drug|Toripalimab|anti-PD-1 antibody
15808819|NCT04376853|Device|Apple Watch Series 5|Digital monitoring via Apple Watch
15808820|NCT04376840|Other|Blood sample and data record|Blood sample and data record
15808825|NCT04376814|Drug|Favipiravir|Patients will be given a stat dose of 1600mg Favipiravir tablets for the first time, and for next time they will be given 600mg of favipiravir tablets three times per day for 7 days
15808826|NCT04376814|Drug|Hydroxychloroquine|200mg of Hydroxychloroquine two times per day will be given to patients for seven days in Test group, and Patients in Control group will be given a stat dose of 400mg Hydroxychloroquine tablets two times per day.
15808827|NCT04376814|Drug|Lopinavir / Ritonavir|Patients will be given 200/50 mg of Lopinavir / Ritonavir two times per day for seven days.
15808828|NCT04376788|Biological|exchange blood transfusion from normal donor|IV method
15808829|NCT04376788|Biological|plasma from convalescent patients with COVID-19|IV method
15808830|NCT04376788|Drug|Methylene Blue 5 MG/ML|IV method
15808831|NCT04376775|Other|Transplant patient|Surveys will be distributed via an email sent by transplant centres or patient's associations. A link to a secure survey platform will be given. A questionnaire will completed by patients. Patients, who agreed to fill the survey, will be offered the possibility to be contacted for a second survey over a 6 months period.
15808834|NCT04376736|Other|Home visit|Home visit by medical provider
15808835|NCT04376723|Other|Mental Health Mobile Application|Mobile phones will not be provided to participants, but app subscriptions will be provided.
15808836|NCT04376710|Other|Completion of pre-pandemic survey|Surgeons will take a pre-pandemic survey to determine surgeon perceptions to telemedicine and barriers to implementation.
15808837|NCT04376710|Other|Completion of survey after peak of pandemic|Surgeons will take another survey after the peak of pandemic to determine surgeon perceptions to telemedicine and barriers to implementation.
15808838|NCT04376710|Other|Completion of post telemedicine encounter survey|Patients will take a post telemedicine encounter survey to determine patient perceptions to telemedicine and barriers to implementation.
15808839|NCT04376697|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|The treatment will be delivered by trained medical personnel.
15808840|NCT04376684|Biological|Otilimab|Otilimab will be administered once via IV route.
15808841|NCT04376684|Biological|Placebo 1|Placebo 1 will consist of sterile 0.9 percent (%) sodium chloride solution administered once via IV route.
15808842|NCT04376684|Biological|Placebo 2|Placebo 2 will consist of sterile 5% dextrose or 5% glucose solution administered once via IV route.
15808843|NCT04376684|Drug|Standard of care|All participants will receive standard of care as per institutional protocol.
15808844|NCT04376671|Device|Electroencephalography|The patients underwent EEG recordings according to previously published methods (Bonanni et al., 2008). . EEG recordings were analyzed with methods described in our previous work (Bonanni et al., 2008) by 2 experimenters unaware of the clinical conditions of the subjects. Briefly, quantitative EEGs (QEEGs) were recorded from 21 scalp derivations. Ag/AgCl disk scalp electrodes (19) were placed according to the international 10-20 system, EEG was recorded from Fp1, Fp2, Fz, F3, F4, F7, F8, Cz, C3, C4, Pz, P3, P4, T3, T 4, T5, T6, O1, and O2. Two additional electrodes were placed on A1 and A2. EEG activity was analyzed from single or multiple leads grouped to define the following scalp regions: anterior (Fz, Fp2, F7, Fp1, F3, F4, and F8), central (Cz, C3, and C4), posterior (Pz, P3, P4, O1, and O2), and temporal (T3, T4, T5, and T6).
15808845|NCT04376658|Other|COVID-19|Proven or suspected SARS-Cov-2 infection
15808846|NCT04376645|Procedure|Mandibular Setback with maxillary impaction|Occlusal bite force will be measured after surgery to correct vertical disproportions
15808847|NCT04376645|Procedure|Mandibular setback only|Occlusal bite force will be measured after surgery without changing vertical disproportions.
15808848|NCT04376632|Dietary Supplement|Pecan ADD|Raw pecan halves without dietary substitution instructions
15808849|NCT04376632|Dietary Supplement|Pecan SUB|Raw pecan halves with instructions to substitute pecans with isocaloric foods in the habitual diet
15808852|NCT04376606|Procedure|Left atrial appendage closure|Left atrial appendage closure is performed using a single endocardial plug devices guided by fluoroscopic guidance and transesophageal echocardiography
15808853|NCT04376606|Procedure|Radiofrequency ablation|Each patient with persistent AF receives circumferential pulmonary vein isolation under the 3D electro-anatomical mapping system , and no additional ablation is performed in the extrapulmonary sites unless the patient is diagnosed with atrial flutter before the operation.
15808854|NCT04376606|Procedure|LAAC combined with radiofrequency ablation group|Each patient received the same group of patients with simple radiofrequency ablation radiofrequency ablation treatment at the same time, the transcatheter occlusion of left atrial appendage opening
15808855|NCT04376593|Drug|18F-αvβ6-BP|Subjects will be injected once per imaging session (a maximum of 3 imaging sessions) with up to 10 mCi (±20%) of 18F-αvβ6-BP as a rapid intravenous bolus (within 30 secs).
15808856|NCT04376567|Other|randomization|subjects scheduled to have a BBAVF will be randomized to either the One-stage or the Two stage BBAVF
15808857|NCT04376554|Drug|TBPM-PI-HBr|TBPM-PI-HBr (2 x 300mg tablets) PO q8h [±1 hour] for 10 days
15808858|NCT04376554|Drug|amoxicillin-clavulanate|amoxicillin-clavulanate (1 × 500mg/125mg tablet) PO q8h [±1 hour] for 10 days
15808859|NCT04376541|Drug|Fentanyl|amount of fentanyl used in both groups
15808860|NCT04376528|Drug|Cyclosporin A|Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with cyclosporin A)
15808861|NCT04376528|Drug|Mycophenolate Mofetil|Ursodeoxycholic acid combination of immunosuppressive agents(methylprednisolone with mycophenolate mofetil )
15808862|NCT04376515|Behavioral|HOPE intervention|Online peer support community of peers trained in behavior change science
15808863|NCT04376502|Radiation|Radiation Therapy|Radiation therapy for all subjects will consist of treating one tumor of the treating physician's preference (40 Gray (Gy) in 5 fractions), and after a 1-week interval during which ICI is continued alone, radiation therapy will be given to a second and separate tumor (30 Gy in 5 fractions).
15808864|NCT04376489|Behavioral|Messages (participants experiencing negative affect & cigarettes are available)|Participants receive messages tailored for situations when they experiencing negative affect & cigarettes are available.
15808865|NCT04376489|Behavioral|Messages (participants not experiencing negative affect & cigarettes are available)|Participants receive messages tailored for situations when they cigarettes are available.
15808866|NCT04376489|Behavioral|Messages (participants experiencing negative affect & cigarettes are not available)|Participants receive messages tailored for situations when they experiencing negative affect.
15808867|NCT04376489|Behavioral|Messages (participants not experiencing negative affect & cigarettes are not available)|Generic messages for situations when participants are neither experiencing negative affect nor cigarettes are available.
15808868|NCT04376489|Behavioral|Moodsurf|"Smart phone app that teaches participants a mindfulness-based technique in which participant surf the mood."
15808869|NCT04376489|Behavioral|Meditate|Smart phone app that teaches participants a mindfulness-based meditation designed for smoking cessation.
15808870|NCT04376489|Behavioral|Joy|Smart phone app that teaches participants to practice breathing exercise.
15808871|NCT04376489|Behavioral|Imagine|Smart phone app that teaches participants to use their imagination to explore and manage their thoughts and feelings.
15808872|NCT04376489|Behavioral|Notice|Smart phone app that teaches participants to accept their thoughts and feelings.
15808873|NCT04376476|Biological|Blood sample|blood samples will be taken as below: Group A1 : At day 0, day 3, day 7, day 14, day 21 Group A2 : At day 0, day 3, day 7, day 14, day 21 Group A3 : At day 0, day 3, day 7, day 14, day 21 Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0
15808874|NCT04376476|Biological|Low or upper respiratory tract sample|"Low or upper respiratory tract sample will be collected in order to take virology measurements:
~Group A1 : At day 0, day 3, day 7, day 14, day 21 Group A2 : At day 0, day 3, day 7, day 14, day 21 Group A3 : At day 0, day 3, day 7, day 14, day 21 Group E1: At day 0 Group E2: At day 0, day 7, day 14 Group E3: At day 0"
15808875|NCT04376476|Biological|Stool collection or fecal swab|"The stool collection or fecal swab will be collected in order to take virology measurements:
~Group A1 : At day 0, day 3, day 7, day 14, day 21 Group A2 : At day 0, day 3, day 7, day 14, day 21 Group A3 : At day 0, day 3, day 7, day 14, day 21 Group E1: / Group E2: At day 0, day 7, day 14 Group E3: At day 0"
15808876|NCT04376476|Genetic|Blood sample for whole genome sequencing|The blood sample for whole genome sequencing will be performed at day 0 for group A1 and A2.
15808877|NCT04376476|Other|phone call|phone calls will be performed to collect data regarding patients' symptoms at: Group A1 : Day 10 Group A2 : Day 10 Group A3 : Day 10 Group E1: Day 14 Group E3: Day 14
15808878|NCT04376463|Dietary Supplement|Branched Chain Aminoacid|It is an experimental design, controlled with 8 months of supplementation combined with exercise and washout 2 months, totalling 10 month intervention.
15808879|NCT04376450|Procedure|Experimental- Nonincised papillae surgical approach|"The basic principle of the technique is the placement of only one buccal horizontal or oblique incision in the mucosa, as apically as possible from the periodontal defect and the marginal tissues, and the raising of a mucoperiosteal flap coronally, which permits apical access to the defect but leaving the marginal tissues intact, acting as a dome for the protection of the clot."
15808880|NCT04376450|Procedure|Active comparator- Entire papilla preservation technique|The entire Papilla Preservation Technique is to preserve the whole integrity of the defect- associated papilla providing a tunnel-like undermining incision. The completely preserved interdental papilla provides an intact gingival chamber to stabilize the blood clot and improve the wound healing process. To provide adequate access for debridement, EPP requires a short buccal vertical releasing incision on the buccal side of the neighboring tooth extending just beyond the mucogingival line.
15808881|NCT04376437|Drug|medical cannabis|inhalation by using a Portable Metered-Dose Cannabis Inhaler
15809548|NCT04371081|Device|Amplatzer Piccolo Occluder|Interventional placement of vascular occluder
15808883|NCT04376411|Diagnostic Test|Flow-cytometric assay|100 µl of blood sample was incubated for 20 minutes at 4 C in the dark. Following incubation, red blood cells lysis, washing and analysis a specific software.Forward and side scatter histogram was used to define the lymphocytes population.
15808884|NCT04376411|Diagnostic Test|2D Echocardiographic analysis|Trans thoracic echocardiographic examination was performed through (PHILIPS -33) echocardiography device with broadband S5-1 transducer
15808885|NCT04376411|Diagnostic Test|Two-Dimensional speckle tracking echocardiography|Two-Dimensional speckle tracking echocardiography was performed on grey scale images of the left ventricle. For offline analysis digital storage software (Qlab 10.4) was used. The frame rate was adjusted to be 60-90 frame/second.
15808887|NCT04376372|Diagnostic Test|Functional testing, Magnetic resonance imaging, Electromyography|Electromyography only for cases (F-Lefthanders), not for controls (TD-lefthanders)
15808888|NCT04376359|Procedure|hyperbaric oxygen therapy|Hyperbaric oxygen therapy is the patient put in airtight oxygen tank, by increasing the air pressure in the environment (1.5 to 3.0) under atmospheric pressure, to give 100% oxygen, the patient treatment time is approximately 60 minutes to 120 minutes in this way, can achieve the purpose of greatly increase the oxygen partial pressure in the organization, so as to achieve reverse brain edema, reduce lipid peroxidation, inhibiting leukocyte hyperactivity, rebuild the blood brain barrier.
15808889|NCT04376346|Behavioral|Native WYSE CHOICES|Native WYSE (Women, Young, Strong, and Empowered) CHOICES (Changing High-risk alcohOl use and Increasing Contraception Effectiveness Study) is an alcohol-exposed pregnancy prevention program that translates CHOICES, an evidence-based targeted intervention, into an mHealth universal intervention for young urban American Indian/Alaska Native (AI/AN) women ages 16-20.
15808890|NCT04376333|Behavioral|Cognitive-Behavioral Treatment|Cognitive-behavioral coping skills training
15808891|NCT04376333|Behavioral|Individualized Assessment and Treatment Program|Experience-sampling based cognitive behavioral coping skills assessment and training
15808892|NCT04376333|Other|Standard Conservative Care|Standard conservative dental care for orofacial pain
15808893|NCT04376320|Device|customised ceramic sheets (Group 1)|guided bone regeneration
15808894|NCT04376320|Combination Product|modified sausage technique (Group 2)|guided bone regeneration
15808895|NCT04376307|Procedure|minimal flow anesthesia|Investigators will use minimal flow anesthesia (0,5 lt/min) during surgery with one lung ventilation
15808896|NCT04376294|Device|Extracorporeal Shockwave Therapy(ESWT)|Each session of Extracorporeal Shockwave Therapy(ESWT) consists of 2000 pulses with a pressure of 3 bars (equals an energy flux density of 0.1 mJ/mm²), and treatment frequency of 8 pulses/sec
15808897|NCT04376294|Other|Eccentric training of the calf muscle:|The patients were asked to stand with all their body weight on the injured leg on a wooden step. From an upright body position and standing with all body weight on the forefoot, with the ankle joint in plantar flexion. The calf muscle is loaded by having the patient lower the affected limb down by dorsiflexion the ankle until the plantar aspect of the heel lay below the level of the step, and the ankle is in maximum dorsiflexion.
15808898|NCT04376294|Other|Gastrocnemius, soleus, and hamstring stretch|Stretching every muscle for 30 seconds. Each stretch was performed 3 times (holding for 30 seconds and rest for 30 seconds). All these stretches were performed directly after the eccentric exercises twice/day for 7 days/week for weeks
15808899|NCT04376281|Drug|Noradrenaline|Noradrenaline infusion for patients undergoing liver transplantaion from living donor .
15808900|NCT04376268|Drug|Chlorhexidine mouthwash|After anesthesia, the horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under abundant irrigation. Following the extraction, granulation tissues were removed, and post extraction cavity was irrigated with sterile 0.9% saline solution. After the bleeding was controlled, the mucoperiosteal flap was repositioned by 3.0 silk sutures. The patients were postoperatively prescribed paracetamol (Parol® 500 mg, Atabay Chemical Industry, Istanbul, Turkey) to use when required with a maximum of 4 doses per day. Patients were instructed to maintain a soft diet, and refrain from mouth washing, brushing and flossing during the first 24 hour. They were also instructed to rinse their mouth with 15 ml of mouthwash for 30 seconds, 3 times a day, and continue until the 7th postoperative day.
15808901|NCT04376268|Procedure|Chlorhexidine mouthwash with boric acid (0.1%)|After anesthesia, the horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under abundant irrigation. Following the extraction, granulation tissues were removed, and post extraction cavity was irrigated with sterile 0.9% saline solution. After the bleeding was controlled, the mucoperiosteal flap was repositioned by 3.0 silk sutures. The patients were postoperatively prescribed paracetamol (Parol® 500 mg, Atabay Chemical Industry, Istanbul, Turkey) to use when required with a maximum of 4 doses per day. Patients were instructed to maintain a soft diet, and refrain from mouth washing, brushing and flossing during the first 24 hour. They were also instructed to rinse their mouth with 15 ml of mouthwash for 30 seconds, 3 times a day, and continue until the 7th postoperative day.
15808916|NCT04376177|Diagnostic Test|Ultrasound|Echodoppler imaging of upper limbs performed by trained operators at rest and during provocative maneuvers for TOS diagnosis.
15808917|NCT04376177|Diagnostic Test|angiography|Angiography (arterial and/or venous) of upper limbs performed by trained operators at rest and during provocative maneuvers such for TOS diagnosis.
15808918|NCT04376177|Diagnostic Test|questionnaires|Use of standard questionnaires (MASC, DASH, SF36) for the evaluation of upper limb symptoms self-completed by the patients at admission.
15808919|NCT04376177|Diagnostic Test|Transcutaneous oximetry|Mesurement of transcutaneuos oxygen pressure on both forearms performed at rest and during provocative maneuversfor TOS diagnosis.
15808902|NCT04376268|Procedure|Chlorhexidine mouthwash with boric acid (0.5%)|After anesthesia, the horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under abundant irrigation. Following the extraction, granulation tissues were removed, and post extraction cavity was irrigated with sterile 0.9% saline solution. After the bleeding was controlled, the mucoperiosteal flap was repositioned by 3.0 silk sutures. The patients were postoperatively prescribed paracetamol (Parol® 500 mg, Atabay Chemical Industry, Istanbul, Turkey) to use when required with a maximum of 4 doses per day. Patients were instructed to maintain a soft diet, and refrain from mouth washing, brushing and flossing during the first 24 hour. They were also instructed to rinse their mouth with 15 ml of mouthwash for 30 seconds, 3 times a day, and continue until the 7th postoperative day.
15808903|NCT04376268|Procedure|Chlorhexidine mouthwash with boric acid (1%)|After anesthesia, the horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under abundant irrigation. Following the extraction, granulation tissues were removed, and post extraction cavity was irrigated with sterile 0.9% saline solution. After the bleeding was controlled, the mucoperiosteal flap was repositioned by 3.0 silk sutures. The patients were postoperatively prescribed paracetamol (Parol® 500 mg, Atabay Chemical Industry, Istanbul, Turkey) to use when required with a maximum of 4 doses per day. Patients were instructed to maintain a soft diet, and refrain from mouth washing, brushing and flossing during the first 24 hour. They were also instructed to rinse their mouth with 15 ml of mouthwash for 30 seconds, 3 times a day, and continue until the 7th postoperative day.
15808904|NCT04376268|Procedure|Chlorhexidine mouthwash with boric acid (1.5%)|After anesthesia, the horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under abundant irrigation. Following the extraction, granulation tissues were removed, and post extraction cavity was irrigated with sterile 0.9% saline solution. After the bleeding was controlled, the mucoperiosteal flap was repositioned by 3.0 silk sutures. The patients were postoperatively prescribed paracetamol (Parol® 500 mg, Atabay Chemical Industry, Istanbul, Turkey) to use when required with a maximum of 4 doses per day. Patients were instructed to maintain a soft diet, and refrain from mouth washing, brushing and flossing during the first 24 hour. They were also instructed to rinse their mouth with 15 ml of mouthwash for 30 seconds, 3 times a day, and continue until the 7th postoperative day.
15808905|NCT04376268|Procedure|Chlorhexidine mouthwash with boric acid (2%)|After anesthesia, the horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under abundant irrigation. Following the extraction, granulation tissues were removed, and post extraction cavity was irrigated with sterile 0.9% saline solution. After the bleeding was controlled, the mucoperiosteal flap was repositioned by 3.0 silk sutures. The patients were postoperatively prescribed paracetamol (Parol® 500 mg, Atabay Chemical Industry, Istanbul, Turkey) to use when required with a maximum of 4 doses per day. Patients were instructed to maintain a soft diet, and refrain from mouth washing, brushing and flossing during the first 24 hour. They were also instructed to rinse their mouth with 15 ml of mouthwash for 30 seconds, 3 times a day, and continue until the 7th postoperative day.
15808906|NCT04376268|Procedure|Chlorhexidine mouthwash with boric acid (2.5%)|After anesthesia, the horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under abundant irrigation. Following the extraction, granulation tissues were removed, and post extraction cavity was irrigated with sterile 0.9% saline solution. After the bleeding was controlled, the mucoperiosteal flap was repositioned by 3.0 silk sutures. The patients were postoperatively prescribed paracetamol (Parol® 500 mg, Atabay Chemical Industry, Istanbul, Turkey) to use when required with a maximum of 4 doses per day. Patients were instructed to maintain a soft diet, and refrain from mouth washing, brushing and flossing during the first 24 hour. They were also instructed to rinse their mouth with 15 ml of mouthwash for 30 seconds, 3 times a day, and continue until the 7th postoperative day.
15808907|NCT04376268|Procedure|Boric acid mouthwash (2%)|After anesthesia, the horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under abundant irrigation. Following the extraction, granulation tissues were removed, and post extraction cavity was irrigated with sterile 0.9% saline solution. After the bleeding was controlled, the mucoperiosteal flap was repositioned by 3.0 silk sutures. The patients were postoperatively prescribed paracetamol (Parol® 500 mg, Atabay Chemical Industry, Istanbul, Turkey) to use when required with a maximum of 4 doses per day. Patients were instructed to maintain a soft diet, and refrain from mouth washing, brushing and flossing during the first 24 hour. They were also instructed to rinse their mouth with 15 ml of mouthwash for 30 seconds, 3 times a day, and continue until the 7th postoperative day.
15808908|NCT04376255|Other|Augmented Reality (AR)|AR headset - a device that the participants will wear over their head and eyes and will add holographic elements to a live view of workplace training scenario
15808909|NCT04376255|Other|Standard In Person Training Simulation|No AR will be used- participants will be trained using standard in person simulation
15808910|NCT04376242|Behavioral|use of virtual reality|The intervention is a virtual reality program designed to immerse participants in a gaming experience to improve anxiety and fear during an oral food challenge.
15808911|NCT04376242|Behavioral|use of standard technology|the active comparator group will be allowed standard technology for distraction during oral food challenge which can include TV, non-VR gaming, tablets and smart phones.
15808912|NCT04376229|Other|Registry|Registry of cancer patients who receive proton radiation therapy
15808913|NCT04376216|Drug|Prednisone|60 mg with dose tapering over 2 months
15808914|NCT04376203|Procedure|Thyroidectomy|Typical Thyroidectomy
15808915|NCT04376190|Radiation|low level laser therapy|In the laser group, patients received LLLT from a semiconductor Gallium Aluminum Arsenide diode laser (SMARTMPRO, LASOTRONIX, Poland) with the following set parameters; 635 nm wavelength in continuous-wave mode, 50 mw power output, 4.5 J/cm2 energy density, 11.25 J total dose per side, 45 seconds/ point, and 8 mm fiber optic tip diameter. Laser was applied (Fig.2) at five points located within TMJ region on both right and left sides in contact with skin as follows: lateral, superior, anterior, posterior, and posterior- inferior points.
15808920|NCT04376177|Diagnostic Test|plethysmography|Photoplethysmography of the forearms or fingers performed at rest and during provocative maneuvers for TOS diagnosis
15808921|NCT04376177|Diagnostic Test|Electromyogram|Electromyography of the upper limbs with encoding of the physician for the presence or abnsence of signs of plexis compression (impairment of the response on C8 T1 erea
15808922|NCT04376177|Diagnostic Test|Standard X-Ray|Standard X-Ray performed for the research of apophysomegaly or additionnal cervical rib.
15808923|NCT04376164|Radiation|low level laser therapy|mandibular anterior teeth were irradiated by gallium aluminum arsenide semiconductor laser with 635 nm wavelength, 6.5J/cm2energy density, for 10 seconds at 10 points (0.2 J/point) on facial and lingual aspects. This protocol was started immediately after first wire insertion and then at days 3,7,14 of the first month and repeated for additional 2 months
15808924|NCT04376151|Other|Acceptance and Commiment Therapy (ACT) bibliotherapy 'Get Out of Your Mind and Into Your Life'|The intervention has been described in the arm/group descriptions.
15808925|NCT04376138|Other|BCI intervention|30 minutes intervention that occurs 3 times per week, with a goal of 12 sessions total.
15808926|NCT04376138|Other|Conventional Therapy|30 minutes intervention that occurs 3 times per week, with a goal of 12 sessions total.
15808927|NCT04376125|Other|Suboccipital inhibition in tension headache|Deep maneuver of myofascial induction in the suboccipital muscles
15808928|NCT04376112|Other|Pharmacist and pillpack intervention|These participants will be randomized into one of the following two cohorts: standard of care (SOC) and pharmacy intervention group (blister packaging + MTM services). For pharmacy intervention (PI) group, the POCT will be used to measure HbA1c and blood pressure (BP) at baseline, 3, and 6 months during medication therapy management (MTM) service. Recommendation from MTM services will be documented in the patients' electronic medical records (EMRs) and shared with their primary care providers. For the SOC group, HbA1c and BP will be measured at the physician's office and researchers will have an access to participants' EMR.
15808929|NCT04376112|Other|Standard of care|None. Regular visits to primary care physician. Will measure HbA1c and blood pressure at baseline, 3, and 6 months
15808930|NCT04376099|Diagnostic Test|Transcutaneous oxygen pressure measurement during the treadmill test|"Calculation of the decrease from rest of oxygen pressure (DROP) throughout the period of rest exercise and recovery.
~The DROP is calculated as chanegs on each limb probe minus changes on a chest reference probe from rest.
~Analysis of the recovery period of the recordings will be done to seach for recovery 50% and 90% from the minimal DROP observed Evaluation of calf and non calf pain during the tests. Evaluation of calf and non calf (buttock or thigh) ischemia during the tests. Ischemia being defined as a monimal DROP lower than minus 15 mmHg."
15808931|NCT04376086|Procedure|Epidural anesthesia|Segmental epidural analgesia
15808932|NCT04376086|Procedure|general anesthesia|general anesthesia
15808933|NCT04376073|Drug|Niraparib|Niraparib 300mg(Body Weigh ≥77 kg)/200mg (Body Weigh <77 kg) po QD day1~21, Anlotinib 12mg po QD day1~14
15808934|NCT04376073|Drug|Anlotinib|Anlotinib 12mg po QD day1~14. Starting dose of anlotinib changed to 10mg from 2020-11-13.
15808935|NCT04376060|Device|Gen-Os®; The soft lamina (OsteoBiol®)|"The xenograft used in this study was the Gen-Os® by OsteoBiol; as described by the manufacturer, it is a carbonated nanocrystal bone mineral and collagen of natural heterologous origin, obtained by the treatment of cortical bone tissue of equine origins. Its granulometry ranges between 0.25 to 1 mm and it is described as being slightly radiopaque.
~The soft lamina (OsteoBiol®) used is a 35x35mm medium curved membrane of porcine origins. Its clinical indications as described by the fabricator: a co-adjuvant for the reconstruction or the partial or complete recovery of lost bone portions, fillers of non-infected, non-sclerotic and well blood bedewed bone defects."
15808936|NCT04376047|Other|Reverse Trendelenburg position|The Reverse Trendelenburg position is a position in which patients' hip and knee are not flexed but the head and chest are elevated at 30° than the abdomen and legs.
15808937|NCT04376047|Other|Semi-recumbent position|The semi-recumbent position is an upright positioning of the head and torso at an angle of 45° while legs are lying on the bed.
15808938|NCT04376034|Biological|Convalescent Plasma 1 Unit|"Each adult recipient will receive 1 units of plasma, each unit will consist of about 200 to 250 mL.
~Each pediatric recipient will receive 10mL/kg up to 1 unit of plasma."
15808939|NCT04376034|Biological|Convalescent Plasma 2 Units|"Those that meet severe or critical criteria will be given 2 units if available or 1 unit if 2 units are not available.
~Those that are given 1 unit may receive the second unit (or the remainder of the maximum pediatric weight calculated amount of plasma up to 1 additional unit) if they progress to severe or critical condition or if already in severe or critical condition but only received 1 unit secondary to shortages.
~Each pediatric recipient will receive 10mL/kg up to 2 units of plasma."
15808940|NCT04376034|Other|Standard of Care|Those that meet mild severity will be allowed to enroll in the study, but will not receive plasma unless there is progression of illness into the moderate/rapid progression or greater category.
15808941|NCT04376021|Behavioral|Babywearing|Increase mother-infant physical contact through babywearing
15808942|NCT04376008|Procedure|Standard prostate biopsy|Transperineal TRUS guided standard prostate biopsy (SB).
15808943|NCT04376008|Procedure|Targeted and standard prostate biopsy|Transperineal Image fusion-guided targeted and standard prostate biopsy (TB+SB).
15808944|NCT04375995|Diagnostic Test|Impulse oscillometry|Impulse oscillometry test will be applied to all groups.
15808945|NCT04375995|Diagnostic Test|Spirometric pulmonary function test|Spirometric pulmonary function test will be applied to all groups.
15808946|NCT04375995|Diagnostic Test|Fractional exhaled nitric oxide (FENO) test|FeNO test will be applied to asthma group.
15808947|NCT04375995|Diagnostic Test|Thorax Computed Tomography|Thorax Computed Tomography will be taken to the asthma group.
15808948|NCT04375995|Diagnostic Test|Blood eosinophil level|The blood eosinophil level will be evaluated to determine the phenotype in the asthma group.
15808949|NCT04375995|Other|Asthma control test|Asthma control test questions will be applied to the asthma group.
15808950|NCT04375995|Other|Asthma quality of life scale|Asthma quality of life scale (AQLQ) will be applied to the asthma group.
15808951|NCT04375995|Diagnostic Test|Chest X Ray|Chest X Ray will be applied to the healthy control group.
15808952|NCT04375982|Diagnostic Test|Venepuncture|Blood tube will be collected from standard venepuncture
15808953|NCT04375982|Diagnostic Test|Fingerstick|Capillary blood will be collected by fingerstick
15808954|NCT04375969|Other|whole body cryostimulation treatment|The WBC is apporved by National Ministry of Health. It uses cryochamber with low temperature -110 oC. The patient, minimally dressed (e.g., bathing suit, socks, clogs, headband, and surgical mask), remains 30sec at -60°C (vestibule) for body adaptation and, then, passes to the cryochamber, at -110°C and stay there 3 minutes.
15808955|NCT04375969|Other|Connection WBC treatment and HIIT training|WBC combination with Exercise HIIT according to Litlle protocol from 2011. This exercise protocol will be applied together with cryo-sessions
15808956|NCT04375969|Other|Control Group|This group willnot to change their daily habits . The measurements will be taken at baseline and at the end of the study
15808957|NCT04375969|Other|HIIT training group|This group will do the training program without cold exposure
15808958|NCT04375956|Drug|Pembrolizumab|Experimental
15808959|NCT04375943|Drug|Antidiabetic|Verify whether the use of innovative antidiabetic therapies could modify echocardiographic parameters and influence cardiological therapy
15808960|NCT04375930|Other|STANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATION|STANDARD STOMA CARE AND COMPLICATION DIAGNOSTIC ALGORITHM EDUCATION: It is consist of skills, discharge, compilation and algorithm education.
15808961|NCT04375930|Other|Control|It consists of only skills and discharge education
15808962|NCT04375917|Device|O2matic|O2matic is a closed-loop-system that controls oxygenadministration according to SpO2. The aim is to maintain SpO2 within a predefined target interval, E.G. 88-92% with the lowest possible supplementation of oxygen by nasal cannula
15808963|NCT04375904|Radiation|Image-Guided Stereotactic Ablative Radiotherapy (IG-SABR)|Image-Guided Stereotactic Ablative Radiotherapy (IG-SABR) delivered in 8 fractions of 7.5 Gy. OAR constraints must be respected but a minimum dose coverage to 95% of the PTV will be allowed down to 75% and a minimum dose to 99% of the GTV allowed at 75%. Respiratory monitoring/active respiratory management will be used. Plans will be created and delivered using photon beams with energies between 6-10 MV.
15808964|NCT04375891|Radiation|Radiation Therapy|30 Gy in 10 fractions of 3 Gy each
15808965|NCT04375891|Radiation|Radiofrequency Ablation (RFA)|Radiofrequency Ablation (RFA) / Vertebral Augmentation
15808966|NCT04375878|Drug|MS1819|MS1819 in enteric capsules. It contains is a yeast-derived (non-porcine) lipase pancreatic enzyme replacement.
15808967|NCT04375878|Drug|Porcine PERT|Porcine PERT is being used a comparator to MS1819 as a second drug/intervention.
15808968|NCT04375865|Drug|AD-2111|celecoxib 200mg
15808969|NCT04375865|Drug|AD-2112|Tramadol 150mg
15808970|NCT04375852|Diagnostic Test|Detection of autoantibodies|Blood was obtained from each patient for testing the endocrine functions and determination of a panel of autoantibodies to the following: Side-chain cleavage enzyme (SSC), Aromatic L-amino acid decarboxylase (AADC), Tryptophan hydroxylase (TPH),Tyrosine hydroxylase ( TH), 17α-hydroxylase (17α-OH), Cytochrome P450 1A2 (CYP1A2), 21-hydroxylase (21-OH), Potassium channel regulatory protein (KCNRG), Tyrosine phosphatase-like protein IA-2 (IA-2), Glutamic acid decarboxylase 65 (GAD65), NACT Leucine-Rich-Repeat-Protein 5 (NALP5), and Interleukin (IL) 22.
15808971|NCT04375839|Device|Zirconia implant|Following standard surgical protocol, Zirconia implant will be placed in horizontally deficient ridge.
15808972|NCT04375839|Device|Titanium implant|Following standard surgical protocol, Titanium implant will be placed in horizontally deficient ridge.
15808973|NCT04375826|Device|Epidural patient controlled analgesia|The device is connected to the epidural catheter prior to surgery and drug administration is started during surgery. The continuous infusion rate is 4 ml / hr. When the button is pressed, 2 ml is additionally administered and the lock time is 20 minutes.
15808974|NCT04375826|Device|Preperitoneal analgesia and IV-PCA|During surgery, the preperitoneal analgesia catheters are inserted into the preperitoneal space and these catheters are connected to the pump with ropivacaine.
15808975|NCT04375813|Drug|eRapa|0.5mg eRapa (encapsulated rapamycin) oral capsules
15808976|NCT04375813|Drug|Placebos|placebo capsules visually identical to eRapa oral capsules
15808977|NCT04375800|Drug|Doravirine|DOR 3.2, 7.2, 30.4, to 40.0 mg capsules/sachets or DOR 100 mg tablet taken once daily by mouth.
15808978|NCT04375800|Drug|2 NRTIs|Participants receive 2 NRTIs per local label by mouth for 96 weeks as background therapy.
15808979|NCT04375787|Drug|Atorvastatin|Patients received 80 mg atorvastatin before elective coronary angiography
15808980|NCT04375774|Device|FFP2|Face Fit test of the FFP2 with the PortaCount® PRO+ 8038 from TSI
15808981|NCT04375774|Device|Facial mask|Face Fit test of a conventional respirator facial mask with the PortaCount® PRO+ 8038 from TSI
15808982|NCT04375774|Device|MFS|Face fit test of a MFS with the PortaCount® PRO+ 8038 from TSI
15808983|NCT04375761|Procedure|Collection of Biological Samples|Biological samples will be collected throughout the study at regular intervals (every 2 weeks) in addition to when illness event(s) occur. All biological samples (e.g. nasal swabs, peripheral blood, stool) will be collected by the caregiver at home using materials provided to the family. At the end of study, additional samples (e.g. nasal secretion and/or saliva samples) may be collected by the family or study staff at a site visit, if feasible.
15808984|NCT04375761|Procedure|Symptom and Exposure Surveys|Symptom and exposure surveys (questionnaires) will be completed throughout the study at regular intervals (every 2 weeks) in addition to when illness event(s) occur. The primary household contact/caregiver will be the designee for ensuring timely questionnaires completion and submission for all household study participants.
15808985|NCT04375748|Diagnostic Test|Performing routine care (clinical and paraclinical tests)|ECG, standard biology and cardiology tests, and routine transthoracic echocardiography (TTE), MRI
15808986|NCT04375748|Diagnostic Test|Examinations for the research:|"Systematic research by polymerase chain reaction (PCR) for Covid-19 in the blood and in an oro-pharyngeal swab, in addition to the usual immunologic, bacteriological, viral and parasitic tests carried out as part of the routine care of all patients with suspected myocarditis.
~A 30-days phone call follow-up (vital status) and a systematic 1-year follow-up will be realized (clinic, biology, ECG, TTE, +/- MRI)"
15809029|NCT04375501|Other|Surgery: Dynamic Hip Screw, hemiarthroplasty, hip replacement, intramedullary nail|If fit for anaesthesia patients may undergo relevant procedure for fractured neck of femur as per NICE guidelines within limitations of resources as defined by BOAST
15809068|NCT04375176|Diagnostic Test|Study of immune-mediated mechanisms in patients tested positive for SARS-CoV-2|Phenotypic and functional analysis of monocytes and NK cells
15808987|NCT04375735|Drug|Bovine Lipid Extract Surfactant|BLES will be administered in doses of 50mg/kg ideal bodyweight, at a concentration of 27mg/ml so a total volume of approximately 2ml/kg will be administered. The material will be instilled via the suction catheter through the ET tube so that the ventilation circuit is not broken. Half of the material will be instilled with the patient positioned on their left and right sides, with a pause to allow 5 min of MV between. The procedure will be repeated at, 24 and 48 hours while intubated, so the patient will receive up to 3 doses. To minimize aerosol generation, all patients will be paralyzed during surfactant administration and the ventilator will be paused. The proposed administration technique, surfactant concentration, volume and dosing schedule is based on previous studies, and has shown to be safe in patients with ARDS.
15808988|NCT04375722|Device|tACS 10-Hz|Low frequency alternating current will be applied.
15808989|NCT04375722|Device|tACS 40-Hz|High frequency alternating current will be applied.
15808990|NCT04375722|Device|tACS sham|Sham stimulation setting will be applied.
15808991|NCT04375709|Other|Physical exercise|The intervention consists out of combined aerobic and strength exercise supervised and guided by specialized physical therapists; additional methods like functional electrical stimulation or oxygen supplementation are added during the main training if indicated.
15808992|NCT04375709|Behavioral|Education sessions|Sessions include information on physical activity (behaviour), coping with stress and anxiety, dyspnoe, or fatigue; Professional support is given in case of risk for nutritional deficits or post-traumatic stress; sessions are conducted by medical specialists or specialized physiotherapists. All sessions are individually-tailored. In case of nutrition or psychological issues individual sessions are guided by specific health-professionals.
15808993|NCT04375696|Drug|Polyglucosamine L112|Polyglucosamine; Ascorbic Acid; Tartaric Acid
15808994|NCT04375696|Other|Placebo|Dicalcium Phosphate; Microcrystalline Cellulose; Iron Oxide (yellow, brown, and black); Magnesium Stearate; Silicon Dioxide
15808995|NCT04375683|Drug|Flumatinib|Flumatinib 600mg per day, taken on empty stomach
15808996|NCT04375657|Combination Product|TRIIM Treatment|Personalized combination of somatropin, metformin, and DHEA
15808997|NCT04375657|Combination Product|Active Control|Metformin and DHEA
15808998|NCT04375644|Other|Questionnaires on psychological quality of life|Assessement of evolution of the psychological quality of life of health professionals during the confinement period linked to the COVID-19 pandemic by two questionnaires (one during the confinement period and the second one month after the end of the confinement period)
15808999|NCT04375631|Drug|Cladribine|Given IV
15809000|NCT04375631|Drug|Cyclophosphamide|Given IV
15809001|NCT04375631|Drug|Cyclosporine|Given IV
15809002|NCT04375631|Drug|Cytarabine|Given IV
15809003|NCT04375631|Biological|Filgrastim|Given SC
15809004|NCT04375631|Procedure|Hematopoietic Cell Transplantation|Undergo HCT
15809005|NCT04375631|Drug|Mitoxantrone|Given IV
15809006|NCT04375631|Drug|Mycophenolate Mofetil|Given IV or PO
15809007|NCT04375631|Drug|Mycophenolate Sodium|Given PO
15809008|NCT04375631|Radiation|Total-Body Irradiation|Undergo TBI
15809009|NCT04375618|Drug|RhEGF|The EGF impregnated membrane will be placed upon the recession site and will be stabilized by suturing it to the lingual papillae using 4-0 absorbable sutures. The flap will be coronally advanced as far as possible to cover the membrane and will be sutured to the buccal interdental papillae with 4-0 absorbable sutures (Trulenetm, Healthium Medtech Pvt Ltd, Bangalore, India). Standard recall and maintenance regimen will be followed and subjects will be encouraged to report to the department on a monthly basis.
15809010|NCT04375618|Drug|Plain Collagen|A collagen membrane without FGF-2 will be used.
15809011|NCT04375605|Drug|5-Fluorouracil|Day 1 q2w: 2600 mg/m² IV over 24 hours
15809012|NCT04375605|Drug|Calcium folinate|Day 1 q2w: 200 mg/m² IV over 2 hours
15809013|NCT04375605|Drug|Oxaliplatin|Day 1 q2w: 85 mg/m² IV over 2 hours
15809014|NCT04375605|Drug|Docetaxel|Day 1 q2w: 50 mg/m² IV over 2 hours
15809015|NCT04375605|Radiation|Radiation|25 fractions (5 each week over 5 weeks) each 1,8 Gy to a total of 45 Gy
15809016|NCT04375605|Drug|Oxaliplatin during radiotherapy|Day 1, 8, 15, 22, 29: 45 mg/m² IV over 2 hours
15809017|NCT04375605|Drug|5-Fluorouracil during radiotherapy|day 1 - 33: 225 mg/m²/day IV continuously
15809018|NCT04375592|Dietary Supplement|Phenylalanine-free protein substitute in tablet form (XPhe minis)|Intervention is a Phenylalanine-free protein substitute in tablet form. Subjects who currently take a concentrated second stage phenylalanine-free protein substitute will be recruited. Subjects will take the study product for 7 days and daily questionnaires will be completed. Subjects will replace some or all of their usual protein substitute with the new product. The amount of study product prescribed will be calculated to provide the same amount of protein as their usual protein substitute. Daily acceptability and tolerance questionnaires will record information on ease of preparation and administration; how it is taken; and any problems or gastrointestinal effects. Additional questions at the beginning and end of the study will record information on taste, appearance, smell, presentation and packaging of the product. Routine weekly finger prick blood spots will be collected and analysed for phenylalanine and tyrosine as usual.
15809019|NCT04375579|Other|Comprehensive geriatric assessment (CGA)|Questionnaires on nutritional status, autonomy and quality of life
15809020|NCT04375566|Other|Patient Decision Aid|More than 20 IT specialists, 15 doctors and 15 patients
15809021|NCT04375553|Other|Aerobic exercise|Intradialytic aerobic exercise
15809022|NCT04375540|Procedure|Upper first premolars extractions|Fixed orthodontic treatment with upper first premolars extraction and space closure using 0.019X0.025 SS AW and elastic chain.
15809023|NCT04375540|Procedure|Upper second premolars extraction|Fixed orthodontic treatment with upper second premolars extraction and space closure using 0.019X0.025 SS AW and elastic chain.
15809024|NCT04375527|Drug|Binimetinib|Given PO
15809025|NCT04375527|Biological|Nivolumab|Given IV
15809026|NCT04375527|Other|Questionnaire Administration|Ancillary studies
15809027|NCT04375514|Drug|ARO-ENaC|single or multiple doses of ARO-ENaC by inhalation of nebulized solution
15809028|NCT04375514|Drug|Placebo|calculated volume to match active treatment by inhalation of nebulized solution
15809273|NCT04373460|Biological|Plasma from a volunteer donor|Plasma collected from a volunteer donor prior to December 31, 2019
15809030|NCT04375488|Other|Resistance Exercise Training|60 minutes resistance exercise training for 8 major muscle groups (quadriceps, hamstring, biceps, triceps, pectoralis major, gluteus medius , gluteus maximus, middle part of deltoid) for 8 weeks, 3 times per week
15809031|NCT04375488|Other|Inspiratory Muscle Training|with % 30 of MIP, 20 minutes inspiratory muscle training for 8 weeks, 3 times per week
15809032|NCT04375475|Dietary Supplement|Bright Changyou probiotic flavored yogurt|Oral consumption of Bright Changyou probiotic flavored yogurt 100 g at a time and twice per day for 28 days. The experimental product has similar package and taste as the comparators.
15809033|NCT04375475|Dietary Supplement|Bright Changyou lactobacillus flavored yogurt|Oral consumption of Bright Changyou lactobacillus flavored yogurt 100 g at a time and twice per day for 28 days.
15809034|NCT04375475|Dietary Supplement|Bright flavored yogurt|Oral consumption of Bright flavored yogurt 100 g at a time and twice per day for 28 days.
15809035|NCT04375462|Device|AspireAssist device|"Allows for aspiration of gastric contents into a receptacle or the toilet to prevent symptoms of nausea, vomiting, and to prevent aspiration.
~Device is placed endoscopically in an identical fashion to a standard PEG tube G 1-2 days after enrollment"
15809036|NCT04375462|Device|Standard decompressive PEG tube|"Allows for gastric drainage to prevent symptoms of nausea, vomiting, and to prevent aspiration.
~Device is placed endoscopically 1-2 days after enrollment"
15809037|NCT04375462|Other|gastric outlet obstruction scoring system (GOOSS) questionnaire|"Gastric outlet obstruction scoring system (GOOSS) questionnaire
~Both groups will receive the questionnaires via a phone call"
15809038|NCT04375462|Other|Modified Gastroparesis Cardinal Symptom Index (GCSI) questionnaire|"Modified Gastroparesis Cardinal Symptom Index (GCSI) questionnaire
~Both groups will receive the questionnaires via a phone call"
15809039|NCT04375462|Other|Patient satisfaction and ease of use survey|"Patient satisfaction and ease of use survey
~Both groups will receive the questionnaires via a phone call"
15809040|NCT04375449|Dietary Supplement|Pep2dia|what is the effect of Pep2dia on postprandial glycemia after a meal rich in carbohydrates (75g)
15809041|NCT04375449|Dietary Supplement|maltodextrin|maltodextrin
15809042|NCT04375436|Drug|NTRX-07-SDD|NTRX-07-SDD for oral administration
15809043|NCT04375423|Behavioral|Ecological momentary assessment and intervention: Behaviorally-dependent messaging|In response to behavioral data submitted intervention arm participants receive messages on their phones reinforcing healthy behaviors or encouraging alternative behaviors to limit risks
15809044|NCT04375423|Behavioral|Ecological momentary assessment only|Participants will receive twice daily and weekly prompts to submit behavioral report data and self-initiate event-contingent behavioral report data submissions
15809045|NCT04375397|Drug|Ibrutinib|Oral Capsule
15809046|NCT04375397|Drug|Placebo|Oral Capsule
15809047|NCT04375384|Drug|Cetuximab|"A loading dose of Cetuximab will be administered intravenously in the first day of treatment. The dose is 400 mg/m2 and will be infused over 2h followed by 1h observation.
~The maintenance dose of Cetuximab is 250 mg/m2 and will be infused over 1h. No further observation time needed.
~The loading dose of cetuximab will be given every 7 days (+/- 2 days) starting 7 days (+/- 2 days) after the loading dose of cetuximab.
~Pre-medicate with 50 mg Benadryl iv before the loading dose of Cetuximab and as per standard of care before the maintenance treatment."
15809048|NCT04375384|Other|Questionnaire administration|Ancillary studies
15809049|NCT04375384|Other|Quality of life assessment|Ancillary studies
15809050|NCT04375371|Procedure|Bariatric surgery|Obese patients who haveundergone bariatric surgery as part of routine clinical management within the indication of this intervention.
15809051|NCT04375358|Biological|Blood and urine samples|To measure the clearance of creatinine, urea, potassium, magnesium, sodium, chlorine...
15809052|NCT04375345|Device|hip arthroplasty|complex primary total hip arthroplasty or revision total hip arthroplasty performed through anterolateral or posterolateral approach
15809053|NCT04375332|Device|HARPOON™ Beating Heart Mitral Valve Repair System|Repair of the chordae tendinae in the mitral valve.
15809054|NCT04375319|Device|OCT|OCT can provide clear in vivo imaging and evaluate the vascular repair after stent implantation by measuring the optical echo of near-infrared light reflection
15809055|NCT04375306|Procedure|RFR guided CABG|All patients will undergo RFR and FFR measurement before CABG. RFR and FFR values will be blinded to the patients. In the experimental arm the decision to revascularize will be based on RFR.
15809056|NCT04375306|Procedure|Angio guided CABG|All patients will undergo RFR and FFR measurement before CABG. RFR and FFR values will be blinded to the patients. In the control arm the RFR values will be blinded to the cardiothoracic surgeon.
15809057|NCT04375293|Other|Microbiome swabs|Swabs for analysis of microbiome
15809058|NCT04375280|Other|"Development of a screening algorithm designed to determine a dysmobility profile in patients with chronic illness."|"Firstly, volunteers will be invited to complete online questionnaires on a secure platform. The mobility assessment will be carried out initially (t1) and up to a maximum of 4 times (t1 to t4) as part of a day hospitalization. Questionnaires will be diverse (SF36, KOOS, HOOS, BROCKER, MNA, TAMPA, etc.) in order to assess several aspects that compose mobility.
~Physical evaluations will include various validated tests (isokinetic strength measure, TUG, 6MWT, Berg Balance Scale, etc.)"
15809059|NCT04375267|Drug|177Lu-DOTA-TATE + olaparib|177Lu-DOTA-TATE in four cycles in combination with escalated doses of olaparib
15809060|NCT04375254|Other|NbB psychopharmacology training|a two part course in psychopharmacology based on Neuroscience based Nomenclature
15809061|NCT04375241|Other|Subjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG Device|Subjects with asymptomatic atrial fibrillation will be screened by using a Mobile ECG Device
15809062|NCT04375228|Drug|Rituximab|375mg/m^2 IV weekly for 4 doses
15809063|NCT04375228|Drug|Tocilizumab|4mg/kg IV once a month for up to 2 doses
15809064|NCT04375215|Procedure|Selective caries removal|After caries removal restoration of tooth will be performed
15809065|NCT04375215|Procedure|Stepwise caries removal|After caries removal restoration of tooth will be performed
15809066|NCT04375202|Drug|Colchicine 1 MG Oral Tablet|Tablets for oral administration, containing 1 mg of the active ingredient colchicine, administered 0.5 mg po every 8 hours x 30 days.
15809067|NCT04375189|Other|High Risk Clinic|"Subgroup of primary care clinic where patients have longer time slots, supervision by one longitudinal attending, bedside presentations"
15809069|NCT04375163|Other|Isokinetic intense exercise protocol|The isokinetic protocol included 6 sets of 10 maximum efforts at 60 °/s of one leg with a 2-minute break between the sets.
15809070|NCT04375163|Other|Massage treatment|"Massage consisted of stroking (30) and petrissage (50) for muscle relaxation, then friction (10), pincement and clapping (30) to prepare muscles for the next set."
15809071|NCT04375150|Drug|Tyrosine kinase inhibitor (TKI)|TKIs
15809072|NCT04375150|Drug|Immuno-oncology (IO)|IOs
15809073|NCT04375137|Diagnostic Test|Oxidative Stress ELISA Kit|Checking oxidative stress markers and redox system status
15809074|NCT04375124|Biological|Biological/Vaccine: Angiotensin peptide (1-7) derived plasma|angiotensin peptide (1-7) derived plasma will be given to COVID-19 positive participants
15809075|NCT04375111|Procedure|Serratus anterior plane block|•Serratus anterior plane block will be carried out with the patient lying in the lateral position. After skin disinfection, the ultrasound probe will be applied parallel to and between the 5th and 6th ribs in the mid axillary region, for identification of the superficial latissimus dorsi muscles and deep anterior serratus muscles. Then, 25 ml of isobaric bupivacaine 0.25% will be injected above the serratus anterior muscle.
15809076|NCT04375111|Procedure|Transversus thoracic plane block|•Transversus thoracic plane block will be carried out with the patient lying in the supine position. After skin disinfection, the ultrasound probe will be applied parallel to and between the 4th and 5th ribs connecting at the sternum. Then, 15 ml of isobaric bupivacaine 0.25% will be injected between the transversus thoracic muscle and the internal intercosatal muscle.
15809077|NCT04375098|Biological|COVID-19 convalescent plasma|COVID-19 convalescent plasma
15809078|NCT04375085|Device|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
15809079|NCT04375072|Device|active tDCS paired with active MBM|Active tDCS with a constant current intensity of 2 milli ampere( mA)will be applied for 20 minutes per session daily for 2 weeks via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and saline-soaked surface sponge electrodes. The meditation intervention will be applied simultaneously with tDCS for 20 minutes per session daily for 2 weeks by a recorded meditation.
15809080|NCT04375072|Device|sham tDCS paired with active MBM|For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2(milli ampere) mA current for 30 seconds. The meditation intervention will be applied simultaneously with tDCS for 20 minutes per session daily for 2 weeks by a recorded meditation.
15809081|NCT04375072|Device|active tDCS paired with sham MBM|Active tDCS with a constant current intensity of 2 mA will be applied for 20 minutes per session daily for 2 weeks via the Soterix 1x1 tDCS mini-CT Stimulator device with headgear and saline-soaked surface sponge electrodes. The sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM.
15809082|NCT04375072|Device|sham tDCS paired with sham MBM|For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds. The sham MBM intervention will be delivered via a CD player that will look identical in both active and sham MBM.
15809083|NCT04375059|Other|using interactive attention training system|using the interactive attention training system to children with Attention Deficit Hyperactivity Disorder
15809084|NCT04375046|Drug|Recombinant Bacterial ACE2 receptors -like enzyme of B38-CAP (rbACE2)|In this study, the experimental group will receive 0.4 mg/kg rbACE2 IV
15809085|NCT04375033|Drug|Sublingual buprenorphine with naloxone|The combination SL-containing buprenorphine contains naloxone in a ratio of 4:1 buprenorphine:naloxone. Participants will be given a 28-prescription at each 28-day visit.
15809086|NCT04375033|Drug|Injectable subcutaneous buprenorphine|Injectable buprenorphine consists of a depot injectable formulation in polymeric solution and releases buprenorphine over a 28-day (4-week) period by diffusion as the polymer biodegrades. The injection will be administered subcutaneously in the abdomen at each 28-day visit.
15809087|NCT04375020|Drug|GABA|GABA nutritional supplement 750mg per day for 6 months
15809088|NCT04375007|Other|Routine care|Physiotherapy intervention in routine care
15809089|NCT04374994|Drug|Avanafil 50 MG|Oral phosphodiesterase type 5 inhibitors
15809090|NCT04374994|Drug|Placebo oral tablet|lactose and maize starch, Egypt
15809091|NCT04374981|Drug|Celecoxib 100mg|Tablets
15809092|NCT04374981|Drug|Montelukast 10mg|Tablets
15809093|NCT04374968|Device|Blood flood restriction cuff|Blood flow restriction cuffs will be used as an augment to physical therapy
15809094|NCT04374955|Dietary Supplement|Activia Probiotics Shot|The product contains Actiregularis - at least 2x106 cfu / g.
15809095|NCT04374955|Other|Routine care|Routine care of the hospital will be provided.
15809096|NCT04374942|Drug|Hydroxychloroquine|Oral Hydroxychloroquine, 400 mg taken once daily, for three months as pre-exposure prophylaxis to prevent COVID-19 in health care workers in the emergency department.
15809097|NCT04374942|Drug|Placebo oral tablet|Placebo pill (same formula as Hydroxychloroquine without active ingredient) taken once daily, for three months.
15809098|NCT04374929|Device|StealthTrac Temporary Pacing Lead Plus Negative Pressure Wound Therapy|Following fixation of the StealthTrac Lead, Negative Pressure Wound Therapy is applied over the incision site.
15809099|NCT04374929|Device|StealthTrac Temporary Pacing Lead Plus Anti-Inflammatory Glucocorticoid|"• Methylprednisolone 125 mg administered over 30 minutes beginning at least 30 minutes prior to the incision and StealthTrac Lead insertion procedure. This intravenous dose can be repeated every 8 hours on day one of the insertion from 1-3 doses depending on the patient's ability to take oral medications. It can be administered daily thereafter until the patient is able to take oral dosing. In normal circumstances, post op day 2, commence oral glucocorticoid (see below for recommended oral dosing).
~Oral (PO) glucocorticoid preparations and dosing:
~Prednisone 40-60 mg orally daily based on BMI category. BMI categories: Low (<18); Medium (18-30); High (>30). Low and medium are assigned 40 mg daily. High BMI is assigned 60 mg daily dose. This while the StealthTrac lead remains in place.
~Methylprednisolone 16-32 mg daily based on BMI (low, medium and high) while the StealthTrac Lead remains in place."
15809129|NCT04374604|Diagnostic Test|Placental growth factor|On admission, the blood samples of consenting participants will be collected and analysed using enzyme linked immunosorbent assay technique to determine the level of PlGF (pg/ml).
15809130|NCT04374591|Drug|Sodium Bicarbonate|Inhalation of Sodium Bicarbonate 8.4% via nebulizer
15809100|NCT04374929|Device|Two StealthTrac Temporary Pacing Leads (Increased Electrode Spacing)|"Once the first StealthTrac Lead is placed using the procedure described in the AtaCor Temporary Pacing System Instructions for Use (DOC-10085), load a second StealthTrac Lead into the same MACH I Delivery Tool, unless it was damaged during insertion of the first StealthTrac Lead, in which case a new MACH I Delivery Tool should be used.
~Insert the second StealthTrac Lead through (1) a different intercostal muscle path within the same intercostal space or (2) within an adjacent intercostal space. Increased electrode spacing is achieved by pacing between the leads."
15809101|NCT04374929|Device|StealthTrac Lead Only (Control)|A single StealthTrac Lead is placed with no additional treatment.
15809102|NCT04374916|Device|Premaquick®|Vaginal secretions are collected prior to any vaginal or endovaginal ultrasound examination to avoid false positives, with the nylon swab provided with the test (placed in the posterior fornix of the vagina for 10 seconds).Then the samples are tested with the Premaquick test. Results are obtained in 10 minutes.
15809103|NCT04374916|Device|PARTOSURE®|An immunochromatographic test wich determines the qualitative in vitro detection of placental alpha microglobulin-1 (PAMG-1) in cervico-vaginal secretions.
15809105|NCT04374890|Device|CP308|3 weeks of baseline followed by 2x3 weeks use of the test device
15809106|NCT04374877|Drug|SRF388|SRF388 is a fully human IgG1 antibody against IL-27. Inhibition of IL-27 with SRF388 reduces STAT1 phosphorylation leading to increased pro-inflammatory (anti-tumor) cytokine secretion (e.g., IFN-g, TNF-a) and decreased expression of inhibitory immune checkpoint receptors (e.g., PD-L1, TIGIT, LAG3) on immune cells that may result in anticancer therapeutic activity.
15809107|NCT04374877|Drug|Pembrolizumab|Pembrolizumab by intravenous (IV) infusion
15809108|NCT04374864|Drug|Trelagliptin|Anti diabetic
15809109|NCT04374851|Device|Polaris miniRITE BTE|The Polaris device is programmed with computer software to match the Hearing loss of the participant.
15809110|NCT04374851|Device|Viron miniRiTE BTE|The Viron Hearing device is programmed with computer software to match the Hearing loss of the participant.
15809111|NCT04374825|Behavioral|Acceptance and Commitment Therapy (ACT)|This intervention consists of 8, 90-minute online group sessions delivered via video conference. Content will be developed by tailoring an ACT intervention to the specific needs of women with MBC, by using qualitative data gathered in patient focus groups. The intervention will incorporate key concepts of ACT (i.e., creating meaning and purpose in life via coping skills, activities in line with patients' values, and mindfulness meditation).
15809112|NCT04374825|Behavioral|Cognitive Behavioral Stress Management (CBSM)|This intervention consists of 8, 90-minute online group sessions delivered via videoconference. Content is drawn from a standard published CBSM intervention previously tested in other studies. The intervention incorporates key concepts of CBSM (i.e., managing stress via deep breathing and relaxation, identifying distorted thoughts,cognitive restructuring, and effective interpersonal communication).
15809113|NCT04374812|Other|Exposure to registered nurses|Change in outcomes associated with a one hour per patient day increase in exposure to registered nurses
15809114|NCT04374812|Other|Exposure to nursing assistants|Change in outcomes associated with a one hour per patient day increase in exposure to nursing assistants
15809115|NCT04374799|Drug|Heparin|two doses of heparin
15809116|NCT04374799|Drug|Placebos|placebo
15809117|NCT04374786|Device|Calm Meditation App|"Meditation is a self-management strategy that can be utilized by anyone to assist with the management of stress. Meditation mobile applications, such as the Calm app, can be used to help manage stress, especially during this uncertain time."
15809118|NCT04374773|Drug|Dronabinol|2.5 mg PO administered once prior to and once after 1 week of hormone therapy
15809119|NCT04374760|Behavioral|SMS-intervention|SMS-intervention consisting of a series of text messages, grounded in behavioral change theory, aimed at generating intention and autonomous motivation to get screened.
15809120|NCT04374747|Behavioral|Dietary Counseling|The counseling approach will employ strategies shown to be successful in previous and ongoing dietary modification studies including supportive and motivational interviewing techniques. Each woman in the diet intervention group will be assigned a trained nutrition coach/counselor. Counselors will focus on helping participants identify and address barriers to achieving the goal of consuming at least 8 to 10 servings of nutrient dense fruits and vegetables each day (e.g., modifying recipes and food preparation). Participants will also receive weekly boxes of fruits and vegetables .
15809121|NCT04374721|Diagnostic Test|circadian gene expression evaluation|patients and controls will undergo circadian gene expression (CLOCK, ARNTL) evaluation at baseline and after 3 and 6 months
15809122|NCT04374708|Diagnostic Test|fMRI|fMRI: body morph test and neurocognitive testing
15809123|NCT04374682|Other|exercises|stretching exercises - physiotherapy modalities - self care instructions
15809124|NCT04374669|Procedure|Neuroplasty with Racz catheter|The patient is placed in the prone position with a pillow placed under the abdomen to correct the lumbar lordosis. After sterile preparation and draping, the epidural space via the sacral hiatus using a 16 gauge needle is accessed. Then, the Racz catheter is advanced to the site of adhesions under the fluoroscopic guidance. The target site is determined by the location of pathology on lumbar MRI, preprocedural epidurography, and clinical symptoms before the adhesiolysis. Adhesiolysis is performed through the high-volume administration of medications, which consist of a combination of a steroid, local anesthetics, hyaluronidase, and 5% hypertonic saline. As needed, the catheter remains in the epidural space for two days, with the additional injection on each of the days.
15809125|NCT04374643|Other|Slef questionnaires fulfilment|Questionnaires to assess the psychological impact of confinement and its evolution over 6 months
15809126|NCT04374630|Drug|Paclitaxel|Commercially available paclitaxel for IV administration will be obtained by clinical sites in US.
15809127|NCT04374630|Drug|Afuresertib|"Each afuresertib 50 mg tablet, intended for oral administration, contains afuresertib (hydrochloride salt) equivalent to 50 mg of afuresertib (free base).
~Each afuresertib 75 mg tablet, intended for oral administration, contains afuresertib (hydrochloride salt) equivalent to 75 mg of afuresertib (free base)"
15809128|NCT04374617|Diagnostic Test|Duplex ultrasound and Computed Tomography Angiography|All venous thromboembolisms suspected will diagnosed with ultrasound and CT-angiography
15809131|NCT04374578|Drug|Dulaglutide 1.5 MG/ML|Dulaglutide 1.5Mg qw sc injection for 4 weeks
15809132|NCT04374565|Drug|High-Titer Anti-SARS-CoV-2 (COVID 19) Convalescent Plasma|Pathogen reduced SARS-CoV-2 convalescent plasma (1-2 units; ~200 mL each for a total of 200-400mls) given preferably in one day, but allowable to be given over 2 days if clinical circumstances delay infusions in 1 day), with titer to be determined after the unit has been infused.
15809133|NCT04374552|Drug|Hydroxychloroquine sulfate &Azithromycin|Drug - Hydroxychloroquine sulfate &Azithromycin
15809134|NCT04374552|Drug|Placebo|Drug - placebo
15809135|NCT04374539|Biological|Plasma exchange|"Plasma exchanges with 5% human albumin and fresh frozen plasma in patients with quick <50% or only with 5% albumin in patients with quick of 50% or more. We will exchange between 1.2 and 1.5 plasma volumes, that will vary according to sex, weight, height and hematocrit.
~Polyclonal immunoglobulin will be administered at a dose of 100 mg / kg ev after each plasma exchange.
~Standar Medical treatment Kaletra:
~lopinavir/ritonavir: 2c/12h 7 days
~Hydroxychloroquine sulfate 400 mg/12h the first day followed by 200 mg /12h 4 days
~Azithromycin 500 mg first day, followed by 250 mg /d 4 days (oral or EV)
~Tocilizumab 400 mg (weight <75Kgs) or 600 mg (weight ≥ 75 Kg)
~Methylprednisolone 250 mg EV three days and 30 mg/d another 3 days
~Anakinra 200mg/ 12h SBC first day, 200mg / 24h SBC two more days
~Clexane 40-60 mg/d"
15809136|NCT04374539|Drug|Standar medical treatmen|"Kaletra: lopinavir/ritonavir: 2c/12h 7 days
~Hydroxychloroquine sulfate 400 mg/12h the first day followed by 200 mg /12h 4 days
~Azithromycin 500 mg first day, followed by 250 mg /d 4 days (oral or EV)
~Tocilizumab 400 mg (weight <75Kgs) or 600 mg (weight ≥ 75 Kg)
~Methylprednisolone 250 mg EV three days and 30 mg/d another 3 days
~Anakinra 200mg/ 12h SBC first day, 200mg / 24h SBC two more days
~Clexane 40-60 mg/d"
15809137|NCT04374526|Biological|COVID-19 Convalescent Plasma|ABO matched pathogen-inactivated CCP is transfused at a dose of 200 ml/day for 3 days (days 1, 2, and 3).
15809138|NCT04374500|Drug|Leptin infusion plus vasodilators in healthy men|This applies only to protocol 2 with two arms (leptin or saline) where four vasodilatators (bradykinin, acetylcholine, sodium nitroprusside and verapamil) were infused concomitantly
15809139|NCT04374500|Drug|Leptin infusion in healthy men|This applies only to protocol 1 when only leptin was given
15809140|NCT04374500|Drug|Vasodilators in CAD patients|This applies only to protocol 3
15809141|NCT04374487|Drug|Convalescent Plasma|200 ml of ABO compatible plasma transfusion will be done to the subject randomized for the test arm therapy
15809142|NCT04374487|Other|Standard Care Therapy|Subjects randomized to control group will be on standard care treatment according to Institutional Protocols.
15809143|NCT04374474|Other|Olfactory retraining|Olfactory retraining Olfactory training is performed by exposing patients twice daily to essential oils with four specific odors, present in glass jars with soaked cotton pads: phenyl ethyl alcohol, rose; eucalyptol, eucalyptus; citronellal, lemon; eugenol, cloves.
15809144|NCT04374474|Drug|corticosteroid nasal irrigation|Nasal irrigation with corticosteroid (budesonide) consists of 240-mL nasal irrigation with Pulmicort Respules (0.5mg) across both nose sides via NeilMed Sinus Rinse bottle (Santa Rosa, California, USA).
15809145|NCT04374474|Other|smell household Items|Participants will receive a paper hand-out about post-viral anosmia with instructions to smell common household items
15809146|NCT04374474|Other|Nasal Irrigation|Participants from all three groups will use nasal rinse (NeilMed Sinus Rinse) two times a day.
15809147|NCT04374461|Drug|N-acetylcysteine|Patients in both arms will receive N-acetylcysteine IV 6 g/day in addition to supportive and/or COVID-19 directed treatments at the discretion of the treating physician. Treatment interruptions for up to 48 hours are permissible if there is a clinical indication to hold the study drug. Patients can restart drug if they have been off drug for less than 48 hours. Patients are also eligible to restart N-acetylcysteine treatment on the same treatment arm without reconsent if they are within the 30 day followup period after their prior course of treatment on this protocol.
15809148|NCT04374461|Other|Peripheral Blood|A total of 16mL of research whole blood will be collected in CPT tubes at baseline, Cycle 2 Day 1 (or as close as feasible, when still coordinating sample collection across patients in a critical-care unit), and at end of study.
15809149|NCT04374448|Procedure|Sinonasal Benign or Malignant Tumor Resection|During sinus tumor resection, margins will initially be estimated with the naked eye. Then the dye, Indocyanine Green (ICG), will be injected through the intravenous line to identify tumor margins and be compared to estimated margins.
15809150|NCT04374448|Procedure|Skull Base Surgery (Assessment of Nasoseptal Flap)|In this surgery, a piece of individuals septum will be used for the reconstruction. The amount of time for the flap to fluoresce Indocyanine Green (ICG) will be measured. It will be ensured that the it is still lighting up at the end of the surgery, indicating it is still receiving a good supply and ensures longevity of the flap.
15809151|NCT04374448|Procedure|Endoscopic Sinus Surgery|During the surgery, the timing of Indocyanine Green (ICG) administration to fluorescence of anterior and posterior ethmoidal artery and of the internal carotid artery will be measured.
15809152|NCT04374448|Procedure|Posterior Epistaxis Management (SPA Ligation)|During surgery timing of Indocyanin Green (ICG) administration to fluorescence of the sphenopalatine artery will be measured.
15809153|NCT04374435|Procedure|MKTP with Surgical blade|In this procedure, the donor skin will be harvested with a surgical blade and the donor skin will be dissociated
15809154|NCT04374435|Device|MKTP with Negative Pressure Instrument|In this procedure, the investigator uses a negative pressure instrument to create a few blisters on the donor skin and use the blisters for grafting after cell dissociation.
15809155|NCT04374435|Device|Suction blister grafting without cell dissociation|In this procedure, an automated suction blister device will be used to create micro domes and these micro domes will be used directly for grafting without dissociation.
15809156|NCT04374422|Behavioral|fsfi survey|sexual behavior Questionaire
15809157|NCT04374409|Dietary Supplement|High-flavanol cocoa powder|Non-alkalized fat-reduced cocoa powder (Natural Acticoa)
15809158|NCT04374409|Dietary Supplement|Low-flavanol cocoa powder|Alkalized fat-reduced cocoa powder (10/12 DDP Royal Dutch)
15809182|NCT04374175|Biological|Blood sample|Blood sample will be performed
15809183|NCT04374162|Procedure|PEEP|different PEEP set on the anesthetic machine
15809184|NCT04374149|Procedure|Therapeutic Plasma Exchange|TPE, five single plasma volume exchanges over 7 days (every day x 2 then every other day x 3) with albumin or FFP replacement if underlying coagulopathy
15809274|NCT04373447|Procedure|lap fundus-calot cholecystectomy|use laparoscopic fundus-calot approach
15809159|NCT04374396|Procedure|Real ultrasound-guided single shot erector spinae plane block (ESP B)|"ESP block will be performed with the patient lying in the lateral position and the surgical side at the top. After skin disinfection, sterile draping will be placed, and ultrasound probe will be sheathed. The level of the block will be at the transverse process of L2, using a 9-12 MHz linear probe and placed in a parasagittal plane 1 cm from the posterior midline. The deep plane to the erector spinae muscle (ESM) will be identified and a 22 Gauge 50 mm insulated needle will be inserted craniocaudally in plane between the transverse process and the fascia of the ESM.
~After negative aspiration, 0.3 mL/kg- of bupivacaine 0.25% will be injected confirming correct position by visualizing the solution lifting the ESM off the transverse process .Spread of LA between the L1 and L4 transverse processes will be thereafter visually tracked with the transducer. In the control group, no local anesthetics will be injected."
15809160|NCT04374396|Radiation|Sham ultrasound-guided single shot erector spinae plane block (ESP B)|"EESP block will be performed with the patient lying in the lateral position and the surgical side at the top. After skin disinfection, sterile draping will be placed, and ultrasound probe will be sheathed. The level of the block will be at the transverse process of L2, using a 9-12 MHz linear probe and placed in a parasagittal plane 1 cm from the posterior midline. The deep plane to the erector spinae muscle (ESM) will be identified and a 22 Gauge 50 mm insulated needle will be inserted craniocaudally in plane between the transverse process and the fascia of the ESM.
~No local anesthetics will be injected"
15809161|NCT04374383|Drug|Phthalocyanine Dye|following LASER assisted SRP, a novel photosensitizer phthalocyanine dye will be placed
15809162|NCT04374383|Drug|LASER assisted SRP|LASER assisted SRP will be carried
15809163|NCT04374370|Biological|SARSCoV2 Convalescent Plasma|Provide expanded access to SARSCoV2 convalescent plasma (EAP) collected from matched donors as described to patients with severe or life-threatening illness owing to COVID-19.
15809164|NCT04374344|Other|Qualitative analysis of PPG, single-lead ECG, and 12-lead ECG measurements|Participants are instructed to qualitatively analyse PPG, single-lead ECG, and 12-lead ECG heart rhythm traces.
15809165|NCT04374331|Other|video-assisted training|The patients in the VAT group watch a training video in the patient rooms before RCR. The VAT prepared by the researchers consisted of information about things to pay attention to in the hospital in the early period after RCR (nursing care on post-operative day 1, early mobilization, pain control, shoulder protection, and wearing/removing the shoulder sling), maintaining ADL at home (bathing, nutrition, eating, sleeping position, driving, doing household chores, sexual life, worship, and safety measures to be taken at home) and gradual exercise programs (for the first 90 days after discharge).
15809166|NCT04374318|Drug|Dexmedetomidine|INTRATHECAL AND INTRAVENOUS
15809167|NCT04374305|Drug|Brigatinib|Oral daily per predetermined dosage per protocol.
15809168|NCT04374292|Behavioral|Family intervention|"Topics covered in each session with intervention group mothers.
~Dietary and physical activity habits and their link to obesity and cardio-metabolic diseases. Children learn about healthy eating habits and health risks at home.
~Food-preparation processes. Selecting and purchasing food and beverages; importance of food groups and their impact on health; importance of fruit and vegetables. Balance between food groups, source of foods, organic or industrialized. Family menu preparation.
~Habits and behaviors surrounding eating processes identified as health or risk factors, such as energy density, portion-size control, controlling emotional eating.
~Beverages. Water versus sugar-sweetened drinks prepared at home or purchased at the store.
~Preventing the risk of cardiovascular diseases by learning healthy eating habits and practicing these habits at home.
~Integration. Practicing the skills learned during the intervention in each stage of preparing food and eating"
15809169|NCT04374292|Other|Usual nutritional consultation|Control group mothers and children (n = 87) were given the usual nutritional consultation and were prescribed diets that covered their energy requirements according to their age and sex. CG mother/child pairs received information regarding food groups and portion sizes, were trained in the use of the food equivalence system to encourage variation, and were instructed on how to prepare the diet at home.
15809170|NCT04374279|Drug|Bicalutamide 150 Mg Oral Tablet|Bicalutamide 150 mg by mouth daily for 7 days
15809171|NCT04374266|Diagnostic Test|physical examination, and computerized tomography|physical examination, and computerized tomography was performed during routine follow-up
15809172|NCT04374253|Drug|Gantenerumab|Group 1 participants who were in the active arm in the double blind part in the parent study (WN29922 or WN39658), will continue to receive open-label gantenerumab 510 mg sub-cutaneously (SC) every 2 weeks (Q2W). Participants who are naive to gantenerumab treatment will be required to undergo the 3 step uptitration scheme before receiving target dose of open label gantenerumab, 510 mg sub-cutaneously (SC) every 2 weeks (Q2W).
15809173|NCT04374253|Drug|Gantenerumab|Group 2 participants who have completed OLE part in the parent study (WN29922 or WN39658), will continue to receive open-label gantenerumab 510 mg sub-cutaneously (SC) every 2 weeks (Q2W)
15809174|NCT04374240|Genetic|AdNRGM|"AdNRGM is an E1-E3 deleted, replication deficient type 5 adenovirus which contains the E. coli NTR gene regulated by the CMV promoter, an internal ribosomal entry site (IRES) and the human GMCSF gene.
~CB1954 [5-(aziridin-1-yl)-2,4-dinitrobenzamide]"
15809175|NCT04374227|Procedure|Osteopathic Manipulative Treatment|Body regions that were treated included head, cervical, thoracic, ribs, lumbar, pelvis, sacrum, lower extremity, and upper extremity.
15809176|NCT04374214|Procedure|Complete Pulpotomy using Mineral Trioxide Aggregate|Inflammed coronal pulp tissue will be removed till the canal orifices and mineral trioxide aggregate placed over the amputated pulp stump.
15809177|NCT04374214|Procedure|Complete Pulpotomy using Simvastain -alphatricalcium phosphate|Inflammed coronal pulp tissue will be removed till the canal orifices and Simvastatin -alpha tricalcium phosphate placed over the amputated pulp stump.
15809178|NCT04374201|Other|2 zirconia FDPs|The United States Public Health Service criteria were used in order to examine technical and esthetic outcomes. Success and survival rates of the zirconia FDPs were calculated. The biological examination was performed analyzing both abutments and contralateral teeth.
15809179|NCT04374201|Other|1 zirconia FDP|The United States Public Health Service criteria were used in order to examine technical and esthetic outcomes. Success and survival rates of the zirconia FDPs were calculated. The biological examination was performed analyzing both abutments and contralateral teeth.
15809180|NCT04374188|Drug|Ciprofloxacin|drug adminstration to ameliorate sepsis incidence
15809181|NCT04374188|Drug|Levofloxacin|levofloxacin pill
15809185|NCT04374149|Drug|Ruxolitinib|TPE, five single plasma volume exchanges over 7 days (every day x 2 then every other day x 3) with albumin or FFP replacement if underlying coagulopathy combined with ruxolitinib 5mg po BID beginning day prior to first TPE and continuing BID for total of 14 days.
15809186|NCT04374136|Drug|AL001|Administered via intravenous (IV) infusion
15809187|NCT04374136|Drug|Placebo|Administered via intravenous (IV) infusion
15809188|NCT04374136|Drug|Open label - AL001|Administered via intravenous (IV) infusion
15809189|NCT04374123|Diagnostic Test|Serological screening for IgG and IgM antibodies against COVID-19|Serum evaluation for IgG and IgM antibodies against COVID-19 in patients in the endoscopy unit during the COVID 19 pandemic
15809190|NCT04374110|Other|Clinical data|Clinical characteristics from medical records
15809191|NCT04374084|Other|Moxibustion plus Cupping|"Moxibustion: The burning of a small, thimble sized, smoldering plug of dried leaves on the skin at an acupuncture point. Usually the plugs contain leaves of mugwort or moxa. Cupping takes the pot as a tool, uses the combustion to remove the air in the pot, causes a negative pressure, and makes it adsorb on the skin of the acupoints. UseBaixiaojiumoxibustion on each acupoint for 10-15 minutes, the temperature of moxibustion should be adjusted within patient's tolerance level. Use diameter of 5-6 cm acuum cupper to cupping on each acupoint for 5-8 minutes."
15809192|NCT04374071|Drug|Methylprednisolone|IV methylprednisolone 0.5 to 1 mg/kg/day in 2 divided doses for 3 days
15809193|NCT04374058|Other|less-frequency hemodialysis|Patients of treatment group would be evaluated quarterly
15809194|NCT04374045|Other|ECG-Holter|Patient will have a ECG-Holter recording during all their hospitalization.
15809195|NCT04374032|Drug|metenkefalin + tridecactide|ENKORTEN® 5 mg + 1 mg Lyophilisate for Solution for Injection
15809196|NCT04374032|Drug|The standard of care|The usual therapeutically established protocol, for the treatment of patients with moderate to severe COVID-19 infection prescribed by The Agency for medicinal products and medical devices of Bosnia and Herzegovina
15809197|NCT04374019|Drug|Ivermectin|"Ivermectin:
~Days 1-2: Weight < 75kg: 4 tabs (12 mg total daily dose) Days 1-2: Weight > 75kg: 5 tabs (15 mg total daily dose)"
15809198|NCT04374019|Drug|Camostat Mesilate|Days 1-14: 2 tab TID after a meal (600 mg total daily dose)
15809199|NCT04374019|Dietary Supplement|Artemesia annua|Days 1-14: tea or coffee pod TID (1350 mg total daily dose)
15809200|NCT04374019|Drug|Artesunate|Days 1-14:
15809201|NCT04374006|Drug|Dienogest|1mg/kg BW/day based on the study by Katayama et al. A DNG in 0,5% carboxymethylcellulose suspension was given orally with metal sound daily 0,2-0,4 mL per day
15809202|NCT04374006|Drug|Propolis|The propolis contains 20 mg in each ml. So, each rat we given 0,2 ml for 50mg/kg propolis treatment and 0,4 ml for 100mg/kg propolis treatment
15809203|NCT04374006|Other|placebo|we gave 0,2 ml to each rat everyday to negative control groups, and we gave no treatment to sham groups
15809204|NCT04373980|Device|phototherapy|estimate CD4 and CD8 subsets in neonates with unconjugated hyperbilirubinemia after exposure to phototherapy
15809205|NCT04373967|Drug|Victoza®.|Patients will receive Victoza®. Both products will be provided as pen-injector.
15809206|NCT04373967|Drug|Metformin Hydrochloride|Patients who were receiving metformin prior to study will continue to receive it during the study.
15809207|NCT04373967|Drug|TQZ2451|Patients will receive TQZ2451.Both products will be provided as pen-injector.
15809208|NCT04373954|Other|Forgiveness Therapy|The Forgiveness Therapy model mainly includes four stages: uncovering, decision, work and deepening. The book 8 Keys to Forgiveness (2015, a forgiveness therapy manual authored by Dr. Enright) is the basis for the therapy as a way to ensure that the treatment is uniformly founded on the forgiveness process developed at the University of Wisconsin-Madison.
15809209|NCT04373954|Other|Carey Guides|The Carey Guides is a primary educational program deliberately chosen and approved by the Department of Corrections in Wisconsin, in which all inmates are encouraged (not required) to complete as they work toward custody reduction. Some aspects emphasized in it include anti-social thinking, emotional regulation, moral reasoning, and so on. It is the basis for the control group therapy as a way to ensure that the treatment has a uniform process as it is taught in the Department of Corrections (DOC) prison system.
15809210|NCT04373941|Drug|Filgrastim|G-CSF is a glycoprotein produced by monocytes, fibroblasts, and endothelial cells. Filgrastim is a human granulocyte colony stimulating factor (G-CSF) produced by recombinant DNA technology with NEUPOGEN® as the Amgen Inc. trademark for filgrastim. G-CSF regulates the production, proliferation and differentiation of neutrophils and hematopoietic stem cell precursors within the bone marrow leading to dose-dependent increase in circulating neutrophils and hematopoietic stem cells in the blood. It is indicated to reduce the incidence of infection in patients with severe neutropenia, for neutrophil recovery in neutropenic patients with bone marrow depletion, to mobilize hematopoietic progenitor stem cell for collection by leukapheresis in hematopoietic stem cell transplantation.
15809211|NCT04373928|Procedure|Drug guided by Mini-PDX/PDX|Chemotherapeutic agents guided by Mini-PDX/PDX will be applied to PC patients and the efficiency will be studied.
15809212|NCT04373915|Behavioral|Remote Bedside Rounding|Parents of infants on the medical team utilizing remote rounding will have the opportunity to participate in rounds by video conferencing at the infant's bedside. Participation will be tracked and surveys regarding stress, satisfaction, and attachment will be completed by parents in both groups.
15809213|NCT04373902|Procedure|Physiological-based cord clamping|See 'Arm'
15809214|NCT04373876|Device|Subcutaneous Implantable Cardioverter Defibrillator|Patients implanted with a totally subcutaneous defibrillator system
15809215|NCT04373850|Behavioral|Home Visit|Physical exam, medication dose titration
15809247|NCT04373603|Drug|Tranexamic acid|TXA is a synthetic lysine analogue that inhibits the activation of plasminogen to plasmin, thus inhibiting degradation of fibrin clots and serving as an antifibrinolytic
15809248|NCT04373603|Other|Saline|sodium chloride and water for use as control
15809249|NCT04373603|Drug|Hyaluronic acid|Hyaluronidase is a spreading or diffusing substance which modifies the permeability of connective tissue through the hydrolysis of hyaluronic acid, a polysaccharide found in the intercellular ground substance of connective tissue
15809272|NCT04373460|Biological|SARS-CoV-2 convalescent plasma|Plasma collected by apheresis from a volunteer donor who has recovered from COVID-19 and who has SARS-CoV-2 antibody (titer ≥ 1:320 or current FDA standard titer)
15809218|NCT04373824|Drug|Ivermectin|Ivermectin 200 to 400 mcg per kg body weight
15809219|NCT04373811|Diagnostic Test|Lung ultrasound|"Lung ultrasound will be performed in 12 thorax area: anterior, lateral and posterior, each area divided in superior and inferior area, for each hemithorax.
~Lung Ultrasound Score (lung aeration) will be recorded using a convex probe with a transverse view. Presence of pleural thickening and subpleural consolidations will be recorded."
15809220|NCT04373811|Diagnostic Test|Muscle ultrasound|"Diaphragm ultrasound will be performed using intercostal view with a linear probe at the zone of apposition for assessing diaphragm thickness and thickening and subcostal anterior view with convex probe to assess diaphragm excursion.
~Thickness of vastus intermedius, rectus femori and tibialis anterior will be measured using ultrasound linear probe. Cross-sectionnal area and echogeneicity of rectus femori and tibialis anterior will be measured using ultrasound linear probe. Penation angle of rectus femori will be assessed using ultrasound linear probe."
15809221|NCT04373798|Diagnostic Test|C-reactive protein|Measurement of CRP value from blood sample taken at covid19 check point (baseline).
15809222|NCT04373785|Radiation|Intensity-modulated radiation therapy|Intensity-modulated radiation therapy (IMRT) in daily fractions of 2.67 Gy given 5 days per week for 3 weeks, for a total of 40.05 Gy.
15809223|NCT04373785|Drug|Temozolomide|"Oral temozolomide (75 mg/m2), given 5 days per week, for 3 weeks during radiotherapy.
~1 month after the discontinuation of radiotherapy, oral temozolomide is restarted at 150 to 200 mg/m2 for 5 days during each 28-day cycle for 12 cycles."
15809224|NCT04373785|Drug|NG101m|Oral NG101m capsule continuously twice daily.
15809225|NCT04373772|Other|abdominal massage|the patients in the AM group were given a total of 30 minutes of AM by the nurses (HD, OM) everyday for 15 minutes in the morning and evening.In this study AM, which included effleurage, strokes, petrissage and vibration techniques, was applied to the patients for 15 minutes in each session at 9:00 am and 9:00 pm.
15809226|NCT04373759|Other|Cardiopulmonary resuscitation|Cardiopulmonary resuscitation
15809227|NCT04373759|Other|Modified Rankin score|"0 - no symptoms at all
~- no significant disability despite symptoms; able to carry out all usual duties and activities
~- Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
~- Moderate disability; requiring some help, but able to walk without assistance
~- Moderately severe disability; unable to walk and attend to bodily needs without assistance
~- Severe disability; bedridden, incontinent and requiring constant nursing care and attention
~- Dead"
15809228|NCT04373746|Device|NICCI|Non-invasive beat-to-beat blood pressure monitor capable of producing a waveform similar to an invasive arterial line.
15809229|NCT04373733|Drug|Favipiravir|Anti-viral
15809230|NCT04373733|Other|Standard of care management|Standard of care management for COVID-19
15809231|NCT04373720|Procedure|Magnetic Resonance Elastography|Undergo MRE
15809232|NCT04373720|Procedure|Magnetic Resonance Imaging|Undergo standard of care MRI
15809233|NCT04373707|Drug|Enoxaparin|"For example (Enoxaparin):
~4000IU twice a day in patients <50kg
~5000IU twice a day in patients 50-70kg
~6000IU twice a day in patients 70-100kg
~7000IU twice a day in patients above 100kg"
15809234|NCT04373707|Drug|Enoxaparin|For example (Enoxaparin): From 4000IU once a day in patients admitted in medical ward to 4000IU twice a day in patients admitted in the ICU. In patients with severe renal insufficiency (GFR=15-30 mL/min/1.73m²), LMWH doses will be reduced by 50%.
15809235|NCT04373694|Procedure|vaginoscopy|vaginal distension with hysteroscope for hysteroscopy morcellation (without speculum or tenaculum forceps)
15809236|NCT04373694|Procedure|standard hysteroscopy|speculum, paracervical block before hysteroscopy morcellation
15809237|NCT04373681|Other|patient-administered questionnaires|patient-administered questionnaires
15809238|NCT04373668|Behavioral|Hypnotic Medication Review|A training programme focused providing guidance on the review and withdrawal process of hypnotic drugs.
15809239|NCT04373668|Behavioral|Structured Sleep Hygiene|Training module on the principle of good sleep hygiene
15809240|NCT04373668|Behavioral|Night Time Care Activities Programme|Training and support package to assist in the development of a personalised night time care plan and support the implementation and dissemination of information within the care home environment
15809241|NCT04373642|Drug|Pebrolizumab + QUADSHOT Radiotherapy|"Treatment will consist of QUAD SHOT radiotherapy combined with pembrolizumab."
15809242|NCT04373629|Behavioral|attentional modulation|Attentional instructions when viewing faces will be given
15809243|NCT04373629|Other|perceptual modulation|Faces will be presented of varying durations
15809244|NCT04373629|Other|naturalistic viewing|Faces will be viewed without specific instructions
15809250|NCT04373590|Behavioral|Decision aid|The chosen intervention is a one-page DA developed by the first author, published and fully described elsewhere (Zisman-Ilani et al., 2017; Zisman et al., 2018) for use during the psychiatric consultation to help patients and clinicians discuss relevant treatment options pertaining to antipsychotics such as medication nonadherence and self-tapering. The DA format is a simple one-page table with rows containing frequently asked questions by patients about their treatment options and the benefits, risks, and implications of differing decisions. The columns display the treatment options available for the treatment decision in question: continuing, adjusting, or discontinuing antipsychotic medications.
15809251|NCT04373577|Procedure|erector spinae plane block|the patient will be placed in the lateral position with the surgical side up for performing erector spinae plane block. After skin preparation, superficial (5-12 MHz) ultrasound transducer will be placed in a longitudinal orientation 1-2cm lateral to the midline at the sacral level. The L2 level will be identiﬁed by counting upward from the sacrum. Following identiﬁcation of the erector spinae muscle (ESM) and transverse process, a 21 G needle will be inserted deep to the erector spinae muscle (ESM) in a cranio-caudal direction. After negative aspiration, the correct needle position will be conﬁrmed with the administration of 0.5-1ml LA. A total volume of 0.5 mL/kg local anesthetic solution will be injected interfascial plane between erector spinae muscle and transverse process for block performance.
15809252|NCT04373577|Procedure|pericapsular nerve group block|the patient will be in supine position. The ilio-pubic eminence (IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be visualized using a linear ultrasound probe. A 22-gauge, 50-mm needle will be introduced in a lateral to medial fashion in an in-plane approach to place the tip of the needle in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, a total volume of 0.5 mL/kg local anesthetic solution will be injected.
15809253|NCT04373564|Procedure|Motor Tests|To assess motor function annually
15809254|NCT04373564|Procedure|Cognitive Tests|To assess cognitive function annually
15809255|NCT04373564|Procedure|Unenhanced-MRI of the brain|The UE-MRI of the brain will be performed at baseline and at the year 5 visit in order to exclude presence of a significant MRI abnormality
15809256|NCT04373564|Procedure|Gadolinium Measurements|Blood samples and spontaneous urine specimens will be collected through the course of the study to measure Gd concentration
15809257|NCT04373564|Drug|Gadoxetate disodium|Administered as defined by the treating physician as part of routine clinical practice
15809258|NCT04373564|Drug|Gadobenate dimeglumine|Administered as defined by the treating physician as part of routine clinical practice
15809259|NCT04373564|Drug|Gadodiamide|Administered as defined by the treating physician as part of routine clinical practice
15809260|NCT04373564|Drug|Gadoterate meglumine|Administered as defined by the treating physician as part of routine clinical practice
15809261|NCT04373564|Drug|Gadobutrol|Administered as defined by the treating physician as part of routine clinical practice
15809262|NCT04373564|Drug|Gadoteridol|Administered as defined by the treating physician as part of routine clinical practice
15809263|NCT04373551|Behavioral|Cultural adaptation of a patient-provider communication tool|Adaptation of a patient-provider communication tool for PrEP uptake utilized among AA women and their providers in a pilot pre/post-intervention design.
15809264|NCT04373538|Behavioral|Trans-C for sleep and circadian function + Memory Support|The Memory Support Intervention will be delivered interwoven with Trans-C. The Memory Support Intervention is designed to improve patient memory for treatment and involves a series of specific procedures that support the encoding and retrieval stages of episodic memory. The memory support strategies are proactively, strategically and intensively integrated into treatment-as-usual to support encoding. Memory support is delivered alongside each 'treatment point', defined as a main idea, principle, or experience that the treatment provider wants the patient to remember or implement as part of the treatment.
15809265|NCT04373525|Other|Genome analysis|Venous blood will be obtained for later genome analysis
15809266|NCT04373512|Drug|Culturelle 10 Billion CFU Capsule (2 doses)|"For the LGG instillation, participants will be instructed to mix the contents of 1 LGG capsule into saline. After mixing, participants will draw up the liquid LGG mixture into a syringe and instill via the intermittent catheter after the last catheterization prior to going to bed. Participants will receive 2 LGG capsules and will repeat this process the following night (Low dose). Subjects will remain in the study for up to 29 months, with participation ending after one completed intervention (2 doses) and post-intervention assessments are complete. If urinary symptoms do not occur warranting instillation during the ensuing 29 months, participants will be asked to return any remaining capsules"
15809267|NCT04373512|Drug|Culturelle 10 Billion CFU Capsule (4 doses)|"For the LGG instillation, participants will be instructed to mix the contents of 1 LGG capsule into saline. After mixing, participants will draw up the liquid LGG mixture into a syringe and instill via the intermittent catheter after the last catheterization prior to going to bed. Participants will receive 4 LGG capsules and will repeat this process twice daily for a total of four doses (High dose). Subjects will remain in the study for up to 29 months, with participation ending after one completed intervention (4 doses) and post-intervention assessments are complete. If urinary symptoms do not occur warranting instillation during the ensuing 29 months, participants will be asked to return any remaining capsules"
15809268|NCT04373499|Behavioral|Virtual Teach to Goal|Virtual Teach-to-Goal is an educational module that teaches children how to use their inhaler properly; this is done with an IPAD. In the module, the child will complete a series of questions as a pre-assessment, watch a video about how to use the inhaler properly, and then answer a series of questions as a post-assessment. If a child answers any questions incorrectly, they will watch the video again and have another chance to answer the incorrect questions. The child will receive instruction by video one or multiple times (up to 3 times), depending on how much they understand after each round of instruction, as demonstrated by their responses to questions.
15809269|NCT04373499|Behavioral|Brief Intervention|There is a handout that describes proper inhaler technique. The RA reads the handout to the child.
15809270|NCT04373473|Drug|PRIM-DJ2727|Fecal Microbiota Transplantation (FMT) product manufactured as PRIM-DJ2727 capsules consists of lyophilized microbiota suspension from well-screened donors. Microbiota from three donors will be combined to make the product.
15809271|NCT04373473|Drug|Placebos|Placebo capsule will be identical to PRIM-DJ2727 but will not contain intestinal bacteria.
15809275|NCT04373447|Procedure|open cholecystectomy|use open approach
15809276|NCT04373434|Behavioral|HH/HF in 2-1-1|Coaching calls, text messages and intervention materials are designed to increase behavioral capability, self-efficacy and behavioral intention to improve the home food environment for healthy eating and weight gain prevention. Interviews will be conducted by trained research staff at baseline, one month post intervention and six months post intervention. Data collectors will implement proper probing techniques to ensure all foods, drinks, supplements, and home-made food item ingredients are included.
15809277|NCT04373434|Behavioral|Control|The control intervention will focus on the same dietary outcomes as HH/HF in 2-1-1, but without the home environment emphasis.
15809278|NCT04373421|Drug|Chlorhexidine Gluconate 0.12 % Mouthwash + benzydamine hydrochloride|After anesthesia, the horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under abundant irrigation. Following the extraction, granulation tissues were removed, and post extraction cavity was irrigated with sterile 0.9% saline solution. After the bleeding was controlled, the mucoperiosteal flap was repositioned by 3.0 silk sutures. The patients were postoperatively prescribed paracetamol (Parol® 500 mg, Atabay Chemical Industry, Istanbul, Turkey) to use when required with a maximum of 4 doses per day. Patients were instructed to maintain a soft diet, and refrain from mouth washing, brushing and flossing during the first 24 hour. They were also instructed to rinse their mouth with 15 ml of mouthwash for 30 seconds, 3 times a day, and continue until the 7th postoperative day.
15809279|NCT04373421|Procedure|St. John's wort oil|After anesthesia, the horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under abundant irrigation. Following the extraction, granulation tissues were removed, and post extraction cavity was irrigated with sterile 0.9% saline solution. After the bleeding was controlled, the mucoperiosteal flap was repositioned by 3.0 silk sutures. The patients were postoperatively prescribed paracetamol (Parol® 500 mg, Atabay Chemical Industry, Istanbul, Turkey) to use when required with a maximum of 4 doses per day. Patients were instructed to maintain a soft diet, and refrain from mouth washing, brushing and flossing during the first 24 hour. They were also instructed to rinse their mouth with 15 ml of mouthwash for 30 seconds, 3 times a day, and continue until the 7th postoperative day.
15809280|NCT04373421|Procedure|Virgin olive oil|After anesthesia, the horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under abundant irrigation. Following the extraction, granulation tissues were removed, and post extraction cavity was irrigated with sterile 0.9% saline solution. After the bleeding was controlled, the mucoperiosteal flap was repositioned by 3.0 silk sutures. The patients were postoperatively prescribed paracetamol (Parol® 500 mg, Atabay Chemical Industry, Istanbul, Turkey) to use when required with a maximum of 4 doses per day. Patients were instructed to maintain a soft diet, and refrain from mouth washing, brushing and flossing during the first 24 hour. They were also instructed to rinse their mouth with 15 ml of mouthwash for 30 seconds, 3 times a day, and continue until the 7th postoperative day.
15809281|NCT04373408|Procedure|ACL repair without anterolateral repair|Surgical repair of the ACL using semitendinous autograft
15809282|NCT04373408|Procedure|ACL repair with anterolateral repair|Surgical repair of the ACL using semitendinous autograft, and surgical repair of the ALL using an allograft (Arthrex, Extra-Articular Augmentation device)
15809283|NCT04373395|Procedure|D-CLAG|Decitabine+Cladribine+Cytarabine+Granulocyte Colony Stimulating Factor
15809284|NCT04373382|Behavioral|Peer Resilience Champion|PRC is supplied to everyone and provides support to hospital staff during the COVID-19 pandemic in a stepped-wedge design.
15809285|NCT04373382|Behavioral|Enriched Survey Feedback|This intervention provides feedback based on answers to questionnaires to those in the Enriched Feedback arm of the study.
15809286|NCT04373369|Drug|Vorolanib|Vorolanib is administered orally at a dose of 200 mg on Days 1 through 21 of each 21-day cycle.
15809287|NCT04373369|Drug|Atezolizumab|Atezolizumab is administered intravenously at a dose of 1200 mg on Day 1 of each 21-day cycle.
15809288|NCT04373356|Device|Resin Infiltration|"Patients will be instructed about enhancing their oral hygiene, and will be asked to brush their teeth twice a day with fluoride toothpaste, and use dental floss daily. In short, teeth will be isolated with a rubber dam and ICON will be applied following the manufacturer's instructions. After that, the rubber dam will be removed and 5% NaF Varnish will be applied.
~Standardized digital bitewing radiograph will be taken at baseline and one year after treatment for caries lesion progression comparison."
15809289|NCT04373356|Device|Sodium Fluoride Varnish|"Patients will be instructed about enhancing their oral hygiene, and will be asked to brush their teeth twice a day with fluoride toothpaste, and use dental floss daily. In short, teeth will be isolated with cotton roll and 5% NaF varnish will be applied following the manufacturer's instructions.
~Standardized digital bitewing radiograph will be taken at baseline and one year after treatment for caries lesion progression comparison."
15809290|NCT04373343|Behavioral|16-week Food Addiction Clinical Treatment (FACT) Program|16-week Food Addiction Clinical Treatment (FACT) Program, first session will be 120 mins, all subsequent sessions will be 90 mins. Treatment will be led, at a minimum, by a full licensed psychologist
15809399|NCT04372394|Drug|surufatinib|Surufatinib: 300 mg as a single dose on Days 1 and 8 with or without food
15809400|NCT04372381|Device|Transcatheter aortic valve replacement (Edwards Sapien Ultra or Medtronic Evolut Pro|Treatment of aortic valve stenosis using transcatheter aortic valve replacement
15810305|NCT04364750|Other|Placebo|Enteric coated capsule with no active ingredient, taken twice daily
15809294|NCT04373304|Other|low FODMAP diet|A diet specifically developed for the management of IBS is the low Fermentable Oligosaccharides, Disaccharides, Monosaccharides, And Polyols (FODMAP) diet. FODMAP is a collective term that includes fructose in excess of glucose, oligosaccharides including fructans/fructo-oligosaccharides (FOS), galacto-oligosaccharides, sugar polyols such as sorbitol and mannitol, and lactose. Controlled studies have established efficacy of the low FODMAP in managing IBS symptoms, but this diet is complex, associated with low calorie intake, and requires individualized explanation and follow-up by an experienced dietician.
15809295|NCT04373291|Biological|BCG-Denmark|Participants randomized to receive BCG will receive one 0.1 ml dose of Mycobacterium bovis BCG live attenuated BCG-Denmark vaccine (AJ Vaccines, Copenhagen, Denmark) by intradermal injection in the left deltoid region.
15809296|NCT04373291|Biological|Saline|Participants randomized to the control group will receive one 0.1 ml dose sterile 0.9 % NaCl by intradermal injection in the left deltoid region.
15809297|NCT04373278|Other|failure of reconstruction of the mandibule by free fibula flap|description of failure of reconstruction of the mandibule by free fibula flap:delay, type of bacteria involved in the failure, treatment, outcome
15809298|NCT04373265|Drug|Relacorilant|Relacorilant, 100 mg soft gel capsules orally once daily
15809299|NCT04373265|Drug|Pembrolizumab|Pembrolizumab 400 mg infusion every 6 weeks
15809300|NCT04373252|Biological|FMT Lower Delivery (FMP 30)|Participants will receive two fecal microbiota transplants via antegrade enema, one week apart.
15809301|NCT04373239|Procedure|Assisted Reproductive Technology|Assisted reproductive technology includes IVF and IVF+ICSI.
15809302|NCT04373226|Behavioral|Magnitude comparison tasks and neuropsychological testing|neuropsychological testing (ZAREKI-R) and magnitude comparison tasks with stimuli of different types (visual, visuo-spatial)
15809303|NCT04373213|Diagnostic Test|Pleth variability index|The usefulness of Pleth variability index in predicting fluid response in patients with COVID 19
15809304|NCT04373200|Biological|Blood samples collection|Blood sample collection at Day 1, day 7, day 14 for all patients. At month 4 for 25 survivors COVID-19 patients
15809305|NCT04373200|Other|Saliva collection|Saliva collection at Month 4 for 25 survivors COVID-19 patients
15809306|NCT04373187|Drug|CC-93538|one injection of 2mL
15809307|NCT04373187|Drug|CC-93538|two injections of 1.2mL
15809308|NCT04373174|Device|Regional oximetry probe|Regional oximetry probe will be placed in the frontal area of the head
15809309|NCT04373174|Procedure|Thoracic Epidural block|Thoracic epidural block will be applied to the patients before the operation begins
15809310|NCT04373161|Device|Home Pulse Oximetry Monitoring|Patients to check their home oxygen saturation three times daily and return to the ED for sustain oxygen <92% or for worsening symptoms.
15809311|NCT04373148|Other|There is no intervention|There is no intervention
15809312|NCT04373135|Behavioral|Brief educational video|A brief educational video will be displayed explaining the mechanics of how SRA policies operate, how they are decided, and what patients' and healthcare workers' rights are surrounding them.
15809313|NCT04373122|Device|REBOA|Resuscitative Endovascular Balloon Occlusion of the Aorta
15809314|NCT04373109|Behavioral|Observation|Observation of intensity of rehabilitation therapy, daily life upper limb use, physical activi-ty engagement, patient-reported quality of life, and motor outcome after stroke
15809315|NCT04373096|Device|current IPAC-UHN PPE|"Fit-tested N95 mask
~Open face shield
~Double extended-cuff"
15809316|NCT04373096|Device|modified IPAC-UHN PPE|"Fit-tested N95 mask
~Hood
~Double extended-cuff gloves"
15809317|NCT04373083|Drug|Cemiplimab|Administered in 3-week intervals
15809318|NCT04373083|Radiation|Involved-site radiotherapy (IS-RT)|Patients will receive IS-RT with a dose of 20 Gy. Involved-site radiotherapy will be carried out on the basis of 3D imaging as described in the protocol
15809319|NCT04373070|Combination Product|CAir|The CAir desk is a custom-built home disease monitoring device. The device consists of a smartphone (A320 [2017], Samsung Group, Seoul, Korea), home spirometer (Air Next Spirometer, NuvoAir, Stockholm, Sweden), physical activity tracker (Charge 3, Fitbit Inc., San Francisco CA, USA), and an air-quality monitor (Foobot, Airboxlab, Esch sur Alzette, Luxembourg). The components of the CAir desk are CE-certified.
15809320|NCT04373057|Dietary Supplement|Galacto-oligosaccharide|GOS will be administered at determined dose levels per protocol once daily from about 30 days before transplant to about 4 weeks after transplant.
15809321|NCT04373057|Dietary Supplement|Maltodextrin|Maltodextrin will be administered at comparable dose level as GOS (in Phase II) once daily from about 30 days before transplant to about 4 weeks after transplant.
15809322|NCT04373044|Drug|Baricitinib|Given PO
15809323|NCT04373044|Drug|Hydroxychloroquine|Given PO
15809324|NCT04373044|Drug|Placebo Administration|Given Po
15809325|NCT04373031|Drug|Pembrolizumab|Pembrolizumab is a humanized anti-PD-1 mAb of the IgG4/kappa isotype with a stabilizing S228P sequence alteration in the Fc region.
15809326|NCT04373031|Drug|IRX 2|IRX-2, is a cell-derived biologic with multiple active cytokine components that acts on multiple cell types of the immune system including T cells, dendritic cells and natural killer cells.
15809327|NCT04373018|Procedure|Sodium hypochlorite|Sodium hypochlorite irrigant will be used during biomechanical preparation.
15809328|NCT04373018|Procedure|Chlorhexidine|Chlorhexidine irrigant will be used during biomechanical preparation.
15809329|NCT04373018|Procedure|Chlorhexidine + Hydrogen peroxide|Chlorhexidine + Hydrogen peroxide irrigant will be used during biomechanical preparation.
15809330|NCT04373005|Diagnostic Test|Nasopharyngeal (NP) swab|A dry swab will be inserted through one nostril straight towards the back of the nasal passage and rotated gently before the swab is removed.
15809331|NCT04372992|Other|Timing of stoma closure|Defining the best timing of stoma closure in relation to adjuvant therapy compliance
15809332|NCT04372979|Drug|Transfusion of SARS-CoV-2 Convalescent Plasma.|2 Convalescent Plasma units of 200-230mL each, inactivated by amotosalen.
15809333|NCT04372979|Drug|Transfusion of standard Plasma.|2 Standard Plasma units of 200-230mL each, inactivated by amotosalen.
15809334|NCT04372966|Device|Total hip arthroplasty|Corail Total hip arthroplasty system, Depuy. Exeter and Contemporary acetabular components, Stryker.
15809401|NCT04372368|Biological|COVID-19 Convalescent Plasma|1-2 units of COVID-19 convalescent plasma will be administered over 1 to 2 hours (rate of 100 to 200 mL/hr)
15809335|NCT04372953|Procedure|Positive End-Expiratory Pressure (PEEP)|"PEEP is the delivery of any level of positive pressure to the lungs during expiration, by any method of assisted respiratory support. As the intervention in the Delivery Room PEEP will be administered via any of:
~Continuous Positive Applied Pressure (CPAP; non-invasive respiratory support) During CPAP, no other type of positive pressure is delivered as the infant supports tidal ventilation using her/his own spontaneous breathing effort.
~Positive Pressure Ventilation (PPV) During PPV, PEEP is delivered between periods of an applied inflating pressure (PIP) delivered at a clinician-determined rate. PPV can be delivered via a mask or other non-invasive interface (also termed non-invasive positive pressure ventilation; NIPPV), or via an endotracheal tube (often termed continuous mechanical ventilation; CMV)."
15809336|NCT04372940|Drug|Tranexamic Acid Irrigation|Tranexamic acid (TXA) is a synthetic lysine analogue that inhibits the activation of plasminogen to plasmin, temporarily inhibiting the degradation of fibrin clots.
15809337|NCT04372940|Other|Saline Irrigation|Saline will serve as the control.
15809343|NCT04372914|Dietary Supplement|BRB Lozenges|Each lozenge is made from 1 gram of freeze-dried black raspberry powder (equivalent to ~5 black raspberries) in the form of a dissolvable slow-release lozenge.
15809344|NCT04372901|Procedure|Digitally constructed frameworks before implant placement|Intervention group in which the edentulous area will be restored with 3-implant screwmented CAD/CAM frameworks constructed based on planned implant positions.
15809345|NCT04372901|Procedure|Digitally constructed frameworks after implant placement|Control group: edentulous area will be restored with 3-implant conventional screw retained CAD/CAM frameworks constructed after implant placement.
15809346|NCT04372888|Behavioral|choice decision frame|active choice for genetic testing
15809347|NCT04372888|Behavioral|opt-in decision frame|"gain frame for genetic testing"
15809348|NCT04372888|Behavioral|opt-out decision frame|"loss frame for genetic testing"
15809349|NCT04372888|Behavioral|enhanced choice (context) decision frame|consequences of genetic testing
15809350|NCT04372888|Behavioral|enhanced choice (norms) decision frame|social norms for genetic testing
15809351|NCT04372888|Behavioral|enhanced choice (affect) decision frame|commitments for genetic testing
15809352|NCT04372875|Behavioral|SHS-derived CDS|This intervention will provide electronic clinical decision support for adolescents who screen at risk or at high risk of an STI.
15809353|NCT04372862|Procedure|Plane block|Two different plane blocks to control post-mastectomy pain
15809354|NCT04372849|Other|Human nasal insulin|single dose of 160 U of human insulin as nasal spray
15809355|NCT04372849|Other|Placebo|Single dose of placebo solution as nasal spray
15809356|NCT04372836|Procedure|Vasopressin injection|The intervention consists of five steps: rupture the ovarian endometrial cyst and remove the ''chocolate fluid;'' inject diluted vasopressin solution into the interface between endometrioma and ovarian parenchyma; stop injecting until the solution overflow; separate the endometrioma away from the ovarian parenchyma; and coagulate bleeding spots and suture the ovary.
15809357|NCT04372823|Behavioral|Policy/program|Policy/program to improve nutrition and increase physical activity
15809358|NCT04372810|Procedure|High Velocity Low Amplitude manipulation (HVLA)|The thrust manipulation technique was used, which consists of high speed and small amplitude manipulation. The therapeutic intervention was performed through decompressive maneuvers for the tibiotarsal joints. The choice of the place of application of the manipulation technique was delimited by the identification of the area or areas with compressive compartmental impairment and joint restriction. The use of the method depended directly on the identification of one or more regions of joint restraint.
15809359|NCT04372810|Procedure|Care assessment and guidance|Evaluation and care guidelines on glycemic control and diabetic foot care.
15809360|NCT04372797|Device|Diagnostic test|A battery of oculomotor tests
15809361|NCT04372784|Device|Cryotherapy|Cryotherapy entails introducing a 9 French catheter via the endoscope's accessory port. The catheter is advanced until it is visualized on the endoscopy monitor. Under 4 psi pressure, liquid nitrogen is sprayed from the catheter for twenty seconds over each four-centimeter segment of stricture
15809362|NCT04372784|Procedure|Esophagogastroduodenoscopy with Balloon Dilatation|This procedure entails deploying a balloon via the accessory port of the esophagogastroduodenoscope under direct visualization and serially inflating the balloon. Balloon dilatation disrupts not only the muscular rings surrounding strictures but also the granulation tissue composing the strictures.
15809363|NCT04372771|Other|Curves Circuit|The Curves Circuit consists performing 13 hydraulic resistance exercise machines that utilize bidirectional resistance that work all major muscle groups. These are interspersed with floor-based calisthenic exercises designed to maintain an elevated heart rate.
15809364|NCT04372771|Other|Weight Watchers|The Weight Watchers program encourages one to increase physical activity.
15809365|NCT04372732|Diagnostic Test|Serum tumor autoantibody detection|All enrolled patients will be tested for ten kinds of tumor autoantibodies using peripheral blood before PD-1 bloackade treatment.
15809366|NCT04372719|Drug|H3N2|
15809367|NCT04372706|Drug|RTX-240|Engineered red cells co-expressing 4-1BBL and IL-15TP
15809368|NCT04372706|Drug|Pembrolizumab|Humanized immunoglobulin G4 programmed death receptor¬ 1 blocking
15809369|NCT04372693|Other|impliminting Online Distance Learning|as a result of (COVID-19) social distancing measures, the Online Distance Learning will be implemented without prior planning for undergraduate nursing students
15809370|NCT04372680|Diagnostic Test|CTUS examination|fully bedside ultrasonographic assessment of lung, cardiac and diaphragm functions
15809402|NCT04372355|Drug|WF10|WF10, the chlorite-based drug is infused at a dose of 0.3 ml/Kg BW, after dilution in 300 mL physiological saline, over a period of 3 h. The drug is applied once a week for five subsequent weeks.
15809403|NCT04372342|Drug|nalbuphine|Nalbuphine hydrochloride has strong analgesic effect, quick effect and long time by stimulating receptor, and has partial antagonistic effect on the receptor, so the incidence of respiratory depression is low in theory.
15809404|NCT04372342|Drug|remifentanil|remifentanil
15809371|NCT04372667|Behavioral|Community score card approach|"The CSC intervention is a participatory community approach. Health care workers (HCWs), PMTCT clients identified the issues that most impacted PMTCT service quality and uptake, and came together to implement actions for improvement. The core implementation strategy is using dialogue in a participatory forum that engages both service users and service providers. The CSC consists of five core phases, repeated on a regular basis (called rounds), for the life of the project. The five core phases include:
~Phase I: Planning and preparation
~Phase II: Conducting the Score Card with the community
~Phase III: Conducting the Score Card with service providers
~Phase IV: Interface meeting and action planning
~Phase V: Action plan implementation and follow-up"
15809372|NCT04372654|Device|Electroducer Sleeve|The device's safety will be assessed at the radial and femoral puncture site
15809373|NCT04372641|Drug|p97 Inhibitor CB-5339 Tosylate|Given PO
15809374|NCT04372628|Drug|Lopinavir/Ritonavir 400 mg/100 mg|Lopinavir/Ritonavir tablets
15809375|NCT04372628|Other|Placebo|Unmatched placebo
15809376|NCT04372615|Drug|Inebilizumab|"RCP: Blinded treatment on Day 1, Day 15,
~Inebilizumab group: Inebilizumab 300 mg intravenous (IV)
~Placebo group: IV matching placebo Prior to enrollment, all participants will receive standard of care, including high-dose corticosteroids (minimum of 3 days of treatment, 1 g methylprednisolone daily or equivalent) AND either IVIg (total dose range between 1.2 and 2 g/kg) OR plasmapheresis (defined as 5 or 6 exchanges).
~Rescue therapy will be given to participants in either treatment group based on the results of the Week 6 assessments. Rescue therapy is cyclophosphamide 750 mg/m2 IV followed by additional doses every 28-30 days until the mRS score is ≤ 3 (at site Principal Investigator's discretion under standard of care)."
15809377|NCT04372615|Drug|Placebo|The placebo group will receive IV matching placebo on Day 1 and Day 15,
15809378|NCT04372602|Drug|Duvelisib|-For patients unable to administer orally, a duvelisib suspension will be administered through a nasogastric/orogastric tube.
15809379|NCT04372602|Procedure|Peripheral blood draw|"First 10 patients enrolled
~Screening, Day 2, Day 4, Day 8, Day 10, Day 15, and Day 29"
15809380|NCT04372602|Drug|Placebo|-Provided by Verastem
15809381|NCT04372589|Drug|Heparin|"Low molecular weight heparin (LMWH) Preferred therapeutic anticoagulant is enoxaparin. Generally regimens: 1.5 mg/kg subcutaneous once daily or 1 mg/kg subcutaneous twice daily. Alternatively, other subcutaneous LMWH used, including tinzaparin (175 anti-Xa IU/kg subcutaneous once daily) or dalteparin (200 IU/kg subcutaneous once daily or 100 IU/kg subcutaneous twice a day).
~Unfractionated heparin (UFH) Commenced, administered, and monitored according to local hospital policy, and guidelines that are used for the treatment of venous thromboembolism (i.e. not for acute coronary syndrome). Intravenous infusion of UFH is according to total body weight and pragmatically adjusted according to local institutional policy to achieve an activated partial thromboplastin time (aPTT) of 1.5-2.5x the reference value. If UFH is used, the availability of a local hospital policy that has specifies an aPTT target in this range or an anti-Xa value is a requirement."
15809382|NCT04372576|Diagnostic Test|Assessment of ventilator-associated pneumonia criteria|Diagnosis of ventilator-associated pneumonia is based upon the routine daily clinical and laboratory parameters.
15809383|NCT04372563|Other|aortic prosthetics|aortic prosthetics
15809384|NCT04372550|Other|Exercise|Resistance and aerobic exercise in addition to standard of care rehabilitation
15809385|NCT04372550|Other|Standard of Care|Standard of care rehabilitation
15809386|NCT04372537|Behavioral|hypnosis|use of hypnosis.
15809387|NCT04372537|Behavioral|standard care|standard clinical procedure
15809388|NCT04372511|Device|Binaural Beats|Device: Sound with Binaural Beats at acoustic frequencies of 256 Hz in one ear and 260 Hz in the opposite ear producing a binaural beat of 4 Hz with a white background noise
15809389|NCT04372498|Drug|Senicapoc (synonyms: ICA-17043; 2,2-bis-(4-fluorophenyl)-2-phenylacetamide)|This study is conducted as open label, with each patient's response determined with an adaptive Bayesian model based on historical and baseline values for the primary endpoints of the trial. 3 monthly dose escalation steps will assess the efficacy of senicapoc in a dose range (10-40 mg/day) which has been used in prior trials for other indications.
15809390|NCT04372485|Behavioral|mHealth Intervention|Adolescents will receive text messages to facilitate treatment adherence
15809391|NCT04372459|Behavioral|Online integrated and stepped psychosocial care|"This program features four levels of care, increasing in intensity of psychosocial care as patients move from one level to the next one.
~Step 1: Screening and monitoring of several psychosocial variables through the central mobile application of the program (App ICOnnecta't).
~Step 2: Online guided and self-help psychoeducation Campus in which patients can consult videos and online resources, co-constructed between health professionals and patients, containing reliable and rigorous information related to the oncological process.
~Step 3: Online community of psychosocial support. Participants can choose from 12 cancer-related discussion forums and share with the community any health-related question that worries them fostering, thus, debate and stimulating peer-support.
~Step 4: Intensive online group psychotherapy (App ICOnnecta't Videoconsultation), based on the Group Positive Psychotherapy program for cancer survivors (Ochoa, Sumalla, Maté, Castejón, Rodríguez et al., 2010)."
15809392|NCT04372459|Behavioral|Usual psychosocial care|This active control group will receive the standard psychosocial treatment for cancer survivors in the participating centers, led by a clinical psychologist and consisting of 8 individual, 45/60-minute sessions, each of which every 1-2 months, focused on providing emotional support and psychoeducation during the first year of primary cancer treatment.
15809393|NCT04372433|Drug|IO-202 Dose Escalation|IO-202 monotherapy
15809394|NCT04372433|Drug|IO-202 Dose Expansion|IO-202 monotherapy
15809395|NCT04372420|Drug|RhBMP-2 absorbable sponge in grade II furcation|The collagen sponge is impregnated with rhBMP-2 at a concentration of 0.5 μg/ml/1cm3 and were stored at 4°C. This rhBMP-2 impregnated collagen sponge was then dispensed at grade II furcation site
15809396|NCT04372420|Procedure|PLATELET RICH FIBRIN in grade II furcation|For preparation of PRF, patient's venous blood is collected into 10ml glass tube or glass-coated plastic tube and centrifuged at 2700 rpm for 12min which leads to two different layers in the test tube, the upper platelet rich fibrin and the lower RBC portion. The formed PRF clot could then be removed from the glass tube and used in grade II furcation
15809397|NCT04372407|Drug|Surufatinib|Surufatinib: 200 mg as single dose on Days 1 and 9
15809398|NCT04372407|Drug|Itraconazole|Itraconazole: 200 mg BID on Day 5, then 200 mg QD on Days 6 to 14
15809405|NCT04372329|Behavioral|CPAP4HealthySleep system|Tailored multimedia messages and tailored feedback messages delivered via web-based system to participants' phones to motivate them to use their CPAP therapy
15809406|NCT04372316|Drug|methylcobalamin|methylcobamin injection 8 weeks or tablet 8 weeks， followed by 24 weeks methylcobamin tablet until 32 weeks
15809407|NCT04372303|Behavioral|Compassion Fatigue Resiliency Program (CFRP)|The purpose of Compassion Fatigue Resiliency Program (CFRP) is to provide oncology-hematology nurses with knowledge and skills that will increase their level of resilience by helping them recognize compassion fatigue, cope with its consequences and work effectively.
15809408|NCT04372290|Other|Product A|Usual brand (UB) filtered, combustible cigarette
15809409|NCT04372290|Other|Product B|Nicorette® White Ice Mint 2 mg nicotine gum
15809410|NCT04372290|Other|Product C|CSD1904-01, a nicotine pouch, 2 mg nicotine
15809411|NCT04372290|Other|Product D|CSD1904-02, a nicotine pouch, 4 mg nicotine
15809412|NCT04372290|Other|Product E|CSD1904-02, a nicotine pouch, 8 mg nicotine (simultaneous use of two 4 mg nicotine pouches)
15809413|NCT04372277|Drug|Enstilar|topical Enstilar foam
15809414|NCT04372264|Drug|Paracetamol|1000 mg of paracetamol ( perfalgan 10mg/ml solutionBristol- Myers Squibb_UK) intravenous (IV) was given 70 patients,
15809415|NCT04372264|Drug|Dexketoprofen|Second Group: dexketoprofen 50 mg ( arveles ampoule -Ufsa- Istanbul) intravenous (IV) was given 70 patients,
15809416|NCT04372264|Drug|Ibuprofen|third group: 400 mg Ibuprofen (İntrafen 400 mg vial-Gen-İstanbul) intravenous (IV) was given 70 patients, which determined to be applied as a group.
15809417|NCT04372251|Procedure|Sinus tarsi approach (STA)|Osteosynthesis
15809418|NCT04372251|Procedure|Percutaneous Arthroscopically Assisted Osteosynthesis (PACO)|Osteosynthesis
15809419|NCT04372238|Behavioral|RAPIDS Intervention|RAPIDS intervention combines a behavioral intervention along with hands-on training to use fentanyl test strips.
15809420|NCT04372238|Behavioral|Standard OEND|In the attention-matched control arm, participants will receive standardized overdose education and naloxone distribution (OEND) training, with attention-control visits at 1, 2, and 3 months. Participants will receive a naloxone kit after completion of the first session, and information regarding where to obtain additional naloxone at subsequent visits. They will have contact with study staff at month 6 and 12 follow-up visits to capture outcome and covariate data.
15809421|NCT04372225|Other|analysis of hypocalcemia|analysis of postoperative calcium and PTH levels
15809422|NCT04372212|Device|Hernia sac inversion and Snaring|"Vertical trans umbilical 5-mm incision [Point A] is made and 5-mm trocar passed under vision using open technique. Pneumoperitoneum is then established with CO2 flow of 1.5-2.5 L/min.
~Both SGDs were used to invert the hernia sac. Then, modified polypectomy snare (SN) was introduced via the trocar at point B and opened inside the abdomen. SGD-C passed inside the loop of SN and re-catches the hernial sac, which was then twisted around its neck several times. SN was closed tightly at the proper neck and coagulation diathermy current was applied to it leading to separation of the hernia sac. Detached sac (grasped by SGD-C) is then pushed antegradely out through the umbilical port."
15809423|NCT04372186|Drug|Placebo|Participants will receive one dose of IV placebo matched to TCZ. Up to one additional dose may be given.
15809424|NCT04372186|Drug|Tocilizumab|Participants will receive one IV infusion of TCZ 8 mg/kg, with a maximum dose of 800 mg. Up to one additional dose may be given.
15809425|NCT04372173|Diagnostic Test|analysis of the concentration of the clotting factors in patients who underwent primary hip arthroplasty|"Blood samples were taken before surgery, 6 hours, two, four, and six days after the procedure. Venous blood samples were taken from peripheral veins.
~All analyzed parameters (fibrinogen, factor II, factor VIII, factor X, D-dimer) were determined using an ACL TOP 500 CTS automated coagulation analyzer.
~All patients were operated on by a single surgical team, with cementless hip replacements implanted, and without tranexamic acid administered in the perioperative period. All patients underwent venous thromboembolic complications prophylaxis.
~The following data were collected: age, body mass index, gender, perioperative risk assessment scale according to the American Society of Anesthesiologists score, blood transfusions, hemoglobin levels before surgery and two days post-surgery, instances of thromboembolic complications. Because of the observational nature of this study no changes in the treatment of patients were made."
15809426|NCT04372160|Other|Dietary assessment|24-hr dietary recall
15809427|NCT04372147|Procedure|MMA embolization|Patients in the intervention group will undergo a CT angiography scan of the supra aortic trunks, followed by MMA embolization procedure within 7 days of the burr-hole surgery in addition to standard medical care
15809428|NCT04372134|Device|repetitive transcranial magnetic stimulation therapy|A sham-controlled double-blind randomized study was undertaken. 28 patients with chronic (>1 year) motor incomplete traumatic SCI were randomized into real rTMS group (n=14) or sham rTMS group (n=14). Real rTMS (20 Hz, a total of 1600 stimuli) or sham r TMS were applied in the motor cortex area of lower extremities during 3 weeks (15 sessions). In addition to rTMS sessions, patients underwent a rehabilitation program including exercises for strengthening, walking and balance.
15809429|NCT04372121|Drug|75 mg linzagolix tablet|For oral administration once daily
15809430|NCT04372121|Drug|200 mg linzagolix tablet|For oral administration once daily
15809431|NCT04372121|Drug|Add-back capsule (E2 1 mg / NETA 0.5 mg)|For oral administration once daily
15809432|NCT04372121|Drug|Placebo tablet to match 75 mg linzagolix tablet|For oral administration once daily
15809433|NCT04372121|Drug|Placebo tablet to match 200 mg linzagolix tablet|For oral administration once daily
15809434|NCT04372121|Drug|Placebo capsule to match Add-back capsule|For oral administration once daily
15809437|NCT04372095|Procedure|oral smears|oral smears
15809438|NCT04372082|Other|Standard of care (SOC)|SOC procedures including self-monitoring and medical follow-up of clinical signs and if necessary any other symptomatic treatment (paracetamol, antibiotics, steroids, oxygen…) during the whole study duration
15809440|NCT04372082|Drug|Association of diltiazem and niclosamide|niclosamide 500 mg x 4 at J1 then 500 mg x 2 per day + diltiazem 60 mg x 3 per day during 10 days in addition to SOC
15809441|NCT04372056|Behavioral|Views and experiences of health care professionals working in intensive care units during the COVID-19 pandemic|Health care professionals
15809442|NCT04372043|Other|Questionnaire|"Sleep Hygiene Index and demographic questions."
15809443|NCT04372030|Other|Online questionnaire|this is an online questionnaire collecting retrospective data on health care use and non-use
15809444|NCT04372017|Drug|Hydroxychloroquine|Participants randomized to hydroxychloroquine will take 800mg on day 1 followed by 400mg on days 2-5.
15809445|NCT04372017|Dietary Supplement|Vitamin D|Participants randomized to placebo will take IU1600 on day 1 and IU 800 on days 2-5.
15809446|NCT04372004|Diagnostic Test|diagnostic tests for COVID-19 infection|Compare the efficacy of diagnostic tests for COVID-19 infection in detecting antibodies and viral-RNA
15809447|NCT04371991|Diagnostic Test|blood test|blood test (serum samples) for biochemical examination
15809448|NCT04371978|Drug|Linagliptin 5 MG|Linagliptin 5 mg PO once daily
15809449|NCT04371965|Drug|Povidone-Iodine|Patients in the experimental group will be asked to gargle with a 1% povidone-iodine solution, spray their nose with the same antiseptic solution, and finally applied 10% povidone-iodine cream in each nostril, all four times a day for five days.
15809450|NCT04371952|Drug|Doxycycline|comparison of doxycycline 200 mg/day to placebo
15809451|NCT04371952|Drug|Placebo|Placebo : lactose, 380 mg/gélule
15809452|NCT04371939|Drug|Romiplostim|"Participants will receive romiplostim at an initial dose of 9 µg/kg subcutaneously per week for at least 1 month depending on their response to study drug.
~Patients failing to achieve a complete platelet response cross over to arm II."
15809453|NCT04371939|Drug|Eltrombopag|"Participants will receive eltrombopag at a dose of 2-3mg/kg daily (ages 0 to 5 years) and 75 mg/daily (>6 years) for at least 1 month depending on their response to study drug.
~Patients failing to achieve a complete platelet response switch to arm I."
15809454|NCT04371926|Drug|Hydroxychloroquine Sulfate|"Patients will receive hydroxychloroquine sulfate 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course.
~Staff will receive HCQ sulfate 400mg/week for 4 weeks"
15809455|NCT04371913|Radiation|600cGY x 5 fractions|Patients will be treated with the fractionation of 30 Gy in 5 fractions over 1-2 weeks, which is the accelerated fractionation scheme of choice for RT naïve patients at New York Presbyterian using EBRT.
15809456|NCT04371900|Behavioral|Mother receives voucher valued at 100% of cost of name-brand IUD (March 4, 2019-December 31, 2021)|M-CARES randomized vouchers for contraception valued up to 100% of inserting a name-brand IUD (e.g., Skyla, Paraguard, Mirena) for women with out of pocket costs at Planned Parenthood. This intervention occurred from March 4, 2019, forward.
15809457|NCT04371900|Behavioral|Mother receives voucher valued at 50% of cost of name-brand IUD (August 26, 2018-March 3, 2019)|M-CARES randomized vouchers for contraception valued up to 50% of inserting a name-brand IUD (e.g., Skyla, Paraguard, Mirena) for women with out of pocket costs at Planned Parenthood. This intervention occurred after November 4, 2019.
15809458|NCT04371887|Other|Local Tailoring|"The guided local tailoring approach will employ a standard structured process, including (1) convening a project team, (2) conducting a local diagnostic process to identify likely barriers using provider/patient survey and interviews with providers/administrators, (3) selecting from a pre-developed menu of implementation strategies categorized by core function (form and function menu), and (4) deploying the selected strategies in collaboration with local implementation and improvement consultants."
15809459|NCT04371874|Drug|Hydrochlorothiazide, Captopril, Nitrendipine, Aspirin|The participants were grouped into a control group and a TDP group. Hypertension of patients in the control group was managed with the original protocol by doctors in village clinics. Patients in the TDP group were supplied with the TDP treatment, for whom different levels of oral administration plans to patients without drugs treatment in original protocol were: G 0 and G I, nifedipine (20mg, bid) or captopril (25mg, tid), hydrochlorothiazide (12.5mg, bid) for patients who couldn't tolerate previous drugs; G II, nifedipine (20mg, bid) plus hydrochlorothiazide (12.5mg, bid), or captopril (25mg, tid) plus hydrochlorothiazide (12.5mg, bid ), triple therapy for patients whose blood pressure did not reach target BP; G III, three drugs combination. Patients with drugs treatments in the original protocol were changed to be treated with the above antihypertension medications which were uniformly supplied by the government.
15809461|NCT04371822|Drug|SnPP Protoporphyrin plus Sunlight exposure|SnPP Protoporphyrin plus Sunlight exposure
15809462|NCT04371822|Drug|SnPP Protoporphyrin plus Sunlight exposure|SnPP Protoporphyrin and Sunlight exposure
15809463|NCT04371822|Drug|SnPP Protoporphyrin plus Sunlight exposure|SnPP Protoporphyrin plus Sunlight exposure
15809464|NCT04371822|Drug|Sulfonatoporphyrin(TPPS) plus Sunlight exposure.|Sulfonatoporphyrin(TPPS) plus Sunlight exposure.
15809465|NCT04371822|Other|placebo|No Intervention
15809466|NCT04371809|Other|DNA methylome|Epigenomics tools combined with bioinformatic analysis to find and correlate putative useful clinical biomarkers with clinical features
15809467|NCT04371796|Drug|Sintilimab injection|Sintilimab injection 200mg, 2cycles of treatment before surgery
15809468|NCT04371783|Procedure|Immediate FET|FET is performed in the first menstrual cycle following the stimulated IVF cycle
15809469|NCT04371783|Procedure|Delayed FET|FET is performed in the second menstrual cycle following the stimulated IVF cycle
15809470|NCT04371757|Drug|α1-adrenergic block|Ninety minutes before starting the experimental exercise protocol, participants will be offered a capsule containing an α-1 adrenoreceptor blocker (Drozazosin; 0.05 mg / kg-1 body weight) and will be instructed to lie down. All capsules will be handled by a specialized pharmacy.
15809471|NCT04371757|Other|Placebo|Ninety minutes before starting the experimental exercise protocol, participants will be offered a capsule containing an placebo (microcrystalline cellulose; 0.05 mg.kg-1 body weight) and will be instructed to lie down. All capsules will be handled by a specialized pharmacy.
15809472|NCT04371731|Other|Care4todayheart failure platform|Platform allowing patients to enter information about their health at home, namely weight and BP and medications
15809473|NCT04371718|Drug|JKB-122|JKB-122 is a TLR antagonist to immune modulate for autoimmune hepatitis
15809475|NCT04371705|Procedure|Erector spinae plane block|The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes using ultrasound guide.
15809476|NCT04371705|Other|control|placebo
15809477|NCT04371692|Other|self-administered questionnaire|Every weeks during 2 months, clinical and occupational questionnaire are performed among a cohort of HCW exposed to covid occupational exposure
15809478|NCT04371692|Diagnostic Test|SARS-Cov2 testing|Every weeks during 2 month, SARS-Cov2 RT-PCR, serological testing are performed among a cohort of HCW exposed to covid occupational exposure
15809479|NCT04371679|Other|No interventions planned|No interventions planned. Observational.
15809482|NCT04371653|Drug|PRIM-DJ2727|administration orally
15809483|NCT04371653|Drug|Placebo|administration orally placebo
15809484|NCT04371640|Drug|Sirolimus 1 MG/ML|Oral solution
15809485|NCT04371640|Drug|Placebo|Oral solution
15809486|NCT04371627|Drug|Viaskin Peanut|Daily epicutaneous delivery
15809487|NCT04371614|Behavioral|Prime Time Sister Circle|The PTSC is a multi-faceted, facilitated, curriculum- and community-based, intensive, support group intervention with 25-30 mid-life African American women per group.
15809488|NCT04371601|Drug|Oseltamivir|Oseltamivir capsules
15809489|NCT04371601|Drug|hormones|a moderate amount of hormone
15809490|NCT04371601|Device|oxygen therapy|oxygen therapy,mechanical ventilation and other supportive therapies
15809491|NCT04371601|Procedure|mesenchymal stem cells|mesenchymal stem cells
15809492|NCT04371588|Other|No Response to Train of Four Stimulation|No response is observed during Train of Four stimulation monitoring during surgery
15809493|NCT04371588|Other|1-2 Response to Train of Four Stimulation|1 to 2 response is observed during Train of Four stimulation monitoring during surgery
15809494|NCT04371575|Drug|Carbamazepine|There is no actual intervention as the study is observational. First choice tratment is Carbamzepine and Oxcarbazepine. In medically refractory patients, first choice surgery is microvascular decompression
15809495|NCT04371549|Procedure|Glue (Dermabond®; Ethicon, Somerville, NJ).|Arm 1: Skin after cesarean section will be closed by glue
15809496|NCT04371549|Procedure|Monocryl|Arm 2: Skin after cesarean section will be closed by running subcuticular sutures using synthetic absorbable monofilament
15809497|NCT04371536|Drug|Ferrous Sulfate|Patients receive ferrous sulfate 3 mg/kg elemental iron once daily in liquid formulation.
15809498|NCT04371536|Behavioral|IRONCHILD|"Delivery of the intervention at each visit should take 15 minutes or less.
~Baseline visit (Session 1) content will be viewed
~At 1-month follow-up visit, additional (Session 2) content will be viewed
~At 3-month final visit, patients will view final (Session 3) content"
15809499|NCT04371523|Drug|Apo-Hydroxychloroquine|Hydroxychloroquine sulfate 400mg PO BID on day one, then 400mg PO weekly, to be taken with meals for two months total.
15809500|NCT04371523|Drug|Matched Placebo|Matching Placebo
15809501|NCT04371510|Other|blood sample|a blood sample is taken on Covid-19 chronic haemodialysis patients with moderate symptoms
15809502|NCT04371484|Other|ICD-10|A collection of ICD-10 codes used within the PMSI that relate to physical abuse.
15809503|NCT04371471|Diagnostic Test|STC-19 score|Score calculated by an algorithm using a vital sign (systolic blood pressure) and biomarkers (complete blood count with differential)
15809504|NCT04371458|Drug|Intraoperative providone-iodine lavage|Intraoperative providone-iodine lavage during resection
15809505|NCT04371445|Drug|Dexamethasone Ophthalmic Insert|DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care including topical antibiotics.
15809506|NCT04371445|Drug|Prednisolone Acetate 1% Oph Susp|Prednisolone acetate 1% eye drops are used 2-4 times daily for 30 days as the current standard of care for treating inflammation and eye pain after cataract surgery. Prednisolone, like dexamethasone, is a steroid. This arm will also receive the standard of care including topical antibiotics.
15809507|NCT04371419|Behavioral|Messaging|"o The video messages each participant in one of the treatment groups sees will be randomized on the following dimensions. The different versions are clearly demarcated in the US Doctors Scripts document.
~Racial or ethnic identity of the doctor delivering the messages: concordant vs. discordant identity to the subject.
~Whether the message includes an acknowledgment of elephant in the room issues for each target group: trust in the medical system or fear of deportation.
~Whether the social distancing component of the message is delivered by Dr. Birx of the CDC or recorded by the MGH physicians.
~Whether individuals are given information about how representative individuals perceive mask wearers of color. This information comes from results of our nationally representative pilot survey.
~Some individuals in a control group will see messages later."
15809508|NCT04371406|Drug|Hydroxychloroquine and Azithromycin|Hydroxychloroquine sulfate (PLAQUENIL®), 200mg x 3 /d, for 10 days AND Azithromycin (ZITHROMAX®), 500mg on D1 and then 250mg/d for the next 4 days, in addition to standard of care
15809509|NCT04371406|Dietary Supplement|Azinc|Dietetary supplement, Azinc form and vitality®, 2 capsules per day, for 10 days, in addition to standard of care
15809510|NCT04371393|Biological|Remestemcel-L|administered twice during the first week, with the second infusion at 4 days following the first injection (± 1 day)
15809511|NCT04371393|Drug|Placebo|administered twice during the first week, with second infusion at 4 days following the first injection (± 1 day)
15809512|NCT04371380|Drug|Cabotegravir Tablets|Cabotegravir tablets will be white to almost white oval shaped film coated tablets with a unit dose of 30 mg and will be administered orally.
15809513|NCT04371380|Drug|Rilpivirine Tablets|Rilpivirine tablets will be off-white, round, biconvex film coated tablets with a unit dose of 25 mg and will be administered orally.
15809514|NCT04371380|Drug|Cabotegravir extended release suspension for injection (long-acting)|Cabotegravir long-acting will be a sterile white to slightly pink suspension containing 200 mg per mL of GSK1265744 as free acid for administration by intramuscular injection.
15809515|NCT04371380|Drug|Rilpivirine extended release suspension for injection (long-acting)|Rilpivirine long-acting will be a sterile white suspension containing 300 mg per mL of rilpivirine as the free base for administration by intramuscular injection.
15809516|NCT04371367|Biological|avdoralimab|intravenous administration of avdoralimab
15809517|NCT04371367|Other|Placebo|intravenous administration of placebo
15809518|NCT04371341|Procedure|erector spinae block by 0.25% bupivacaine|A mark will be applied on the required level (T8), the midline (spinous processes) and the injection points 3 cm from midline.While the patient is in a sitting position with support from a member of staff, Preparation of the field with iodine will be made. Using ultrasound guidance with a 6-10 MHz linear probe anatomical landmarks will be identified including the transverse process at T8 level and the three layers of muscles from posterior to anterior: trapezius-rhomboid-erector spinae. After subcutaneous lidocaine 2% injection a 22-G spinal needle will be inserted under ultrasound guidance in plane, aiming towards the transverse process. After a Gentle contact with the transverse process, 0.25% bupivacaine is injected in increments with careful repetitive aspiration to avoid intravascular injection.
15809519|NCT04371328|Other|RECOP unit patient|"All patients admit in RECOP unit for dyspnea can be included in this study if patient is agree. Then, doctor collects demographic variables, the usual history and treatments, the characteristics of the episode (symptomatology, evolution, treatment taken) and the data from the initial clinical examination will be identified.
~30 days after inclusion, virological status and mortality will be collect"
15809520|NCT04371302|Diagnostic Test|Questionnaire|Assessment of demographics, burnout, depression and self-perceived medical errors
15809521|NCT04371276|Other|No intervention|Blood samples will be collected from recruited subjects from invited households for testing for hepatitis B (HBsAg, anti-HBs and anti-HBc) and hepatitis A (anti-HAV)
15809522|NCT04371263|Other|Emotional Change of Nursing Manpower in Emergency and Critical Unit After Keen Election And What's The Influence of Emotional Change|use the emotion regulation questionnaire (ERQ) to realize the influence in duty work
15809523|NCT04371250|Other|Survey and Questionnaire|Resilience and Loneliness questionnaires
15809524|NCT04371237|Device|Compression sleeve|From foot to hip/groin on both legs with only 1 leg connected to pneumatic pump for 1 hour
15809525|NCT04371237|Device|Heat therapy|Custom leg garment with one leg heated by circulating hot water approx 40 degrees C, the other leg approx 32 degrees C (thermoneutral) for 1 hour
15809526|NCT04371237|Other|Glycogen-depleting exercise session|Prolonged intermittent high intensity running (LIST protocol)
15809527|NCT04371237|Other|Nutrient Intake (beverage)|Post-exercise, all participants will receive a beverage containing 1.0 g/kg carbohydrate and 0.3 g/kg protein from the mixture of Gatorade Recover Protein Shake and Gatorade Thirst Quencher
15809528|NCT04371237|Procedure|Skeletal muscle biopsy|Vastus lateralis muscle in the lower thigh will be obtained by the percutaneous needle technique
15809529|NCT04371224|Drug|Irinotecan Liposomal Injection [Onivyde]|both arm
15809530|NCT04371224|Drug|Capecitabine|NaliCap
15809531|NCT04371224|Drug|5-fluorouracil|NAPOLI
15809532|NCT04371224|Drug|Leucovorin|NAPOLI
15809533|NCT04371211|Behavioral|Telemedicine Brain Injury Coping Skills|"BICS is a 12 session (one session per week), manualized, cognitive-behavioral treatment group designed to provide support, coping skills, and psychoeducation aimed to improve perceived self-efficacy (PSE) and emotional functioning. PSE has been found to be strongly linked to social participation, increased positive regard toward the caregiving role, and was found to be the greatest contributing factor to predicting life satisfaction.
~For this study, the Brain Injury Coping Skills (BICS) group intervention will be administered electronically in a web-based group telemedicine platform, BICS-T. The purpose of this phase is to test the feasibility, participant training protocol, and ease of use of equipment and technology."
15809534|NCT04371198|Other|Biopsy|Tissue biopsy
15809535|NCT04371185|Drug|BAT2206|45mg/0.5 ml; single dose；prefilled syringe; subcutaneous injection
15809536|NCT04371185|Drug|Stelara(US-licensed)|45mg/0.5 ml; single dose；prefilled syringe; subcutaneous injection
15809537|NCT04371185|Drug|Stelara(EU-licensed)|45mg/0.5 ml; single dose；prefilled syringe; subcutaneous injection
15809538|NCT04371172|Other|cognitive research battery, MRI, laboratory values|cognitive research battery, MRI, laboratory values
15809539|NCT04371159|Device|Velieve U.S.|The Velieve U.S. is a home use, in-vitro diagnostic (IVD) device. The device is used for the semi-quantitative detection of blood and leukocytes, and the qualitative detection of nitrites in urine.
15809540|NCT04371146|Drug|Methylphenidate|35 mg methylphenidate (Ritalin®) is administered once using a randomized placebo-controlled between subject's design
15809541|NCT04371146|Drug|Reboxetine|8 mg Reboxetine (Edronax®) is administered once using a randomized placebo-controlled between subject's design
15809542|NCT04371146|Drug|Placebos|A placebo pill is administered once using a randomized placebo-controlled between subject's design
15809543|NCT04371133|Diagnostic Test|Adropin (ng/L)|Thawed samples were measured on a Molecular Devices SpectraMax i3 Multi-Mode, Microplate Reader (batch number: SER 35 370-1448, made in Austria) using enzyme linked immunosorbent assay (ELISA).
15809544|NCT04371120|Diagnostic Test|BICS Q|assess perceived self-efficacy (PSE) regarding a person's brain injury and proved responsive to treatment effects in the original BICS study.15-16 Specifically, it measures a person's perceptions about his or her ability to both understand the effects of brain injury, as well as, perceived capability of managing BI-related challenges. As the literature suggests, it is important to utilize a measure that would assess PSE specific to the person's challenge, rather than a general PSE scale.
15809545|NCT04371107|Other|consultation|Patients are followed up by teleconsultation or remote follow-up until the end of symptoms and for a maximum of 2 months
15809546|NCT04371107|Drug|Azithromycin|azithromycin treatment 500 mg on day 1 then 250 mg the following 4 days from day 2 to day 5, per os.
15809547|NCT04371094|Device|a device to facilitate endotracheal intubation|a device to facilitate endotracheal intubation
15809549|NCT04371068|Biological|Culture of removed prosthesis using DTT|No specific or supplementary intervention is performed among patients. The included patients have scheduled surgery consisting of prosthesis removal or change. Instead of being discarded, the prosthesis which was removed during the surgery was sent to the laboratory using the MicroDTTect system and bacterial culture was performed with the fluid obtained. Results will be then compared to classical culture of periprosthetic tissues (PPT).
15809550|NCT04371055|Other|7-day Holter ECG|7-day Holter ECG at baseline and after 3 and 12 months and then annually until the end of the study or the first (in patients with low risk of atrial fibrillation)
15809551|NCT04371055|Other|Implantable cardiac monitor|Continuous rhythm monitoring using an implantable cardiac monitor
15809552|NCT04371055|Other|Standard of care|Usual care according to current guidelines (in patients with low and high risk of atrial fibrillation)
15809553|NCT04371029|Other|PSG|Polysomnography at 3 times, actimetry measure and Pittsburgh questionnaire
15809554|NCT04371016|Other|Verticalization (bed)|"The use of a dedicated bed (Total Lift Bed™, VitalGo Systems, Inc., Arjo AB) allows the verticalization of patients under sedation and mechanical ventilation up to 90°. The procedure foresees the gradual verticalization of the patients of 0°, 30°, 60° and 90° by steps of 30 minutes.
~At the end of each position step (0°, 30°, 60° and 90°), measurement of end-expiratory lung impedance (EELI) and chest electrical impedance tomography (EIT) parameters, measurement of esophageal pressures, collection of ventilatory parameters on the ventilator, collection of Swan-Ganz catheter hemodynamic data, measurement of lung shunt by mixed venous and arterial blood gas analyses and measurement of end-expiratory lung volume (EELV) by the N2 washin-washout method"
15809555|NCT04370990|Device|O2matic|O2matic is a closed-loop-system that controls oxygenadministration according to SpO2. The aim is to maintain SpO2 within a predefined target interval, E.G. 88-92% with the lowest possible supplementation of oxygen by nasal cannula
15809556|NCT04370977|Drug|Coartem™ (Artemether-lumefantrine combination)|AL (Coartem™) was administered twice daily for three days (six doses in total) with dosage determined according to body weight: one tablet (20mg artemether and 120mg lumefantrine) for children 5 to <15kg, two tablets per dose for those 15 to <25kg, and three tablets per dose for those 25 to <35kg.
15809557|NCT04370977|Drug|Winthrop™ (Amodiaquine-artesunate combination)|AQ-AS (Coarsucam™) was administered once daily according to body weight: one 25mg artesunate and 67.5mg amodiaquine tablet in children <9kg, one 50mg artesunate and 135mg amodiaquine tablet in children 9-17.9kg; and one 100mg artesunate and 270mg amodiaquine tablet in children >18-35kg.
15809558|NCT04370964|Other|Lausanne Trilogy Play|"Trilogical game of Lausanne (Lausanne Trilogue Play in English abbreviated LTP), which allows an evaluation of the family alliance. This systematic observation provides a snapshot of the family structure and its adaptive abilities. It is based on the assumption that the ability to solve small tasks is representative of the ability to solve more important tasks.The LTP consists of modelling the different possibilities of interaction in a triad according to a four-part scenario: 1) one parent plays with the child, the other parent is simply present; 2) the parents switch roles; 3) both parents play together with the child; and 4) both parents have to talk together."
15809559|NCT04370964|Other|Lausanne Family Play|Lausanne Family Play (LFP) is a game situation adapted to families with more than one child. Thus, like the LTP, the LFP takes place in four phases:1) one parent plays with siblings while the other is in a third-observer position; 2) the parents reverse their roles;3) children play while parents are talking and 4) family members play together.
15809560|NCT04370951|Procedure|Erector Spinae Plane Block - Ultrasound guided|20mls 0.25% Levobupivicaine ultrasound guided bilaterally
15809561|NCT04370938|Behavioral|Coping strategies video|No additional description
15809562|NCT04370925|Procedure|Radical colectomy|Patients undergo radical resection of the primary colorectal cancer(open or laparoscopic/robotic)
15809563|NCT04370925|Procedure|HIPEC|HIPEC(simultaneously or within 2days after resection) with mitomycin c (30 mg/m2) at 43°C for 90 minutes.
15809564|NCT04370925|Drug|Systemic chemotherapy|"Systemic chemotherapy regimens: CapeOx and mFOLFOX6 are preferred for stage Ⅲ patients.
~CapeOx:oxaliplatin 130 mg/m2 IV d1 + capecitabine 1000mg/m2 po bid d1-14. Repeat every three weeks for eight cycles.
~mFOLFOX6:oxaliplatin 85 mg/m2 IV d1 + leucovorin calcium 400 mg/m2 IV d1 + 5-FU 400 mg/m2 IV bolus d1 + 5-FU 2400 mg/m2 continuous IV over 46-48 hours d1-2. Repeat every two weeks for twelve cycles.
~For stageⅡpatiens, regimens recommend by NCCN guide line(2019 v1) are acceptable."
15809565|NCT04370912|Diagnostic Test|Bed side Ultrasound|Handgrip strength will be measured using a digital grip strength dynamometer (Sammons Preston, Nottinghamshire, UK). This measurement is carried out three times using the subject's dominant hand, and then averaged
15809566|NCT04370899|Other|lifestyle assessment|"A semi-quantitative assessment of the consumption of different food groups will be carried out using a frequency questionnaire validated by the Spanish population27. This questionnaire consists of 137 food items and will be obtained by the dietitian of our Unit (see annex).
~The child population and/or their parents will be instructed on how to fill the data in the food diary for a period of 3 days, in order to be able to analyse the nutritional composition of the intake and the effect on the lipid profile. The first food register, will be obtained at the collection visit before starting any type of treatment. Another food diary will be included after one year.
~Physical activity will be collected from the Minnesota Test and we will ask about the consumption of tobacco."
15809567|NCT04370886|Behavioral|blood donation SMS|The literature shows that the information extraction and processing in emergency is different from the normal situation. To find the most effective emergency recruitment method during an outbreak, we intervened with a well-balanced group of donors by presenting different emergency recruitment text messages.
15809568|NCT04370873|Drug|MK-5475|MK-5475 32 µg, 100 µg, 195 µg, 360 µg or 380 µg administered as dry powder inhalation according to randomization
15809569|NCT04370873|Drug|Placebo|Placebo administered as dry powder inhalation according to randomization
15809570|NCT04370847|Procedure|Spinal Anesthesia|Performed at the L3-L4 or L4-L5 interspace using a 25-gauge spinal needle
15809571|NCT04370847|Drug|Intrathecal Bupivacaine|Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space
15809572|NCT04370847|Drug|Intrathecal Fentanyl|Fentanyl 15 μg will be administered in the subarachnoid space
15809573|NCT04370847|Procedure|Cesarean Delivery|Lower segment cesarean section using the Pfannenstiel incision
15809661|NCT04370236|Drug|Placebo|Patients will receive up to two once per week subcutaneous injections of Placebo
15809574|NCT04370847|Radiation|lung ultrasound scans|lung ultrasound scans will be performed while the patient is in the supine position with left lateral tilt by 30 degrees using a 2-5 MHz curved array transducer. The echo comet score (ECS) which corresponds to the amount of EVLW will be obtained by the 28-rib interspaces technique. An increased amount of (EVLW) is diagnosed by multiple B-lines or 'comet tails' which are defined as discrete laser-like vertical hyperechoic reverberation artifacts that arise from the pleural line and extend to the bottom of the screen without fading and move synchronously with lung sliding. The sum of the B-lines found on each of the 28 chest-wall areas yields the ECS.
15809575|NCT04370847|Other|Ultrasound Assessment of the Inferior Vena Cava|The IVC largest and smallest diameters will be measured proximal to the opening of the M-mode using s2-4 MHz transducer placed longitudinally in the subcostal region.
15809576|NCT04370847|Other|Optic nerve sheath diameter|Optic nerve sheath diameter measurement will be conducted in two axes of transverse and oblique sagittal using a 12-4MHz linear array transducer. Depth of the optic nerve will be localized and marked at 3 mm behind the retinal and optic nerve junction transverse diameter of optic nerve sheath will be calculated. The reported ONSD corresponds to the mean of the four values obtained for each patient transverse and sagittal plane for both eyes.
15809577|NCT04370847|Drug|ringer acetate|1000 ml ringer acetate will be administered over 2 hours.
15809578|NCT04370847|Drug|Intravenous Ephedrine|Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 120, 110, and 90 mmHg, respectively.
15809579|NCT04370847|Drug|Intravenous Syntocinon|Immediately after delivery, syntocinon 10 IU will be added to the running crystalloid solution.
15809580|NCT04370834|Biological|Tocilizumab|Given IV
15809581|NCT04370808|Other|Exposure|Individuals with SARS-CoV-2 exposure and COVID-19 symptoms.
15809587|NCT04370782|Drug|Hydroxychloroquine|Hydroxychloroquine 400mg twice a day (BID) on day 1, followed by 200mg BID for days 2-5
15809588|NCT04370782|Drug|Azithromycin|Azithromycin 500mg on day 1, followed by 250mg once daily for days 2-5
15809589|NCT04370782|Drug|Zinc Sulfate|Zinc sulfate 220mg once daily for 5 days
15809590|NCT04370782|Drug|Doxycycline|Doxycycline 200 mg once daily for 5 days
15809591|NCT04370756|Dietary Supplement|Beetroot Juice|Participants randomly assigned to the EX + BR group will consume 140 mL beetroot juice containing approximately 12 mmol of nitrate 3 hours prior to the supervised exercise training component.
15809592|NCT04370756|Other|Beetroot Juice Placebo (deplete of nitrate)|Participants randomly assigned to the EX + PL group will consume 140 mL beetroot juice placebo deplete of nitrate 3 hours prior to the supervised exercise training component.
15809593|NCT04370756|Other|Exercise Training|Participants will perform 8 weeks of supervised exercise training at a frequency of 3x per week.
15809594|NCT04370743|Other|No intervention|
15809595|NCT04370730|Other|clinical, neuroimaging and DNA assessments|Selected assessments, including evaluation of treatment response to specific antipsychotic drugs, will be performed at follow-up visits after 1, 3 and 5 years
15809596|NCT04370717|Other|telehealth consultation|"A telehealth consultation will be scheduled and conducted without modifications from the routine clinic protocol. The case report will include ICD-10 code and plan of care.
~After one week, patients will receive an electronic satisfaction survey. An in-person follow-up and/or procedural visit will be subsequently scheduled. During this visit, the same physician will complete physical examination, document the diagnosis and proceed with either the same or modified plan of care. The research coordinator will enter diagnostic and procedural codes in the case report form."
15809597|NCT04370704|Drug|INCAGN02385|INCAGN02385 administered intravenously
15809598|NCT04370704|Drug|INCAGN02390|INCAGN02390 administered intravenously
15809599|NCT04370704|Drug|INCMGA00012.|INCMGA00012 administered intravenously
15809600|NCT04370691|Device|JETi Thrombectomy System|Thrombectomy
15809601|NCT04370678|Behavioral|Change in preference to surgery under COVID-19 pandemic.|Under the COVID-19 pandemic all arthroscopic procedures were cancelled. We wished to describe if patients experienced a change in preference to surgery under this period.
15809602|NCT04370665|Device|Exablate BBBD with Cerezyme|"Blood Brain Barrier Disruption via Exablate to deliver Cerezyme.
~Other Names:
~Exablate Neuro"
15809603|NCT04370639|Device|AccuFlow sensor|AccuFlow sensor will be worn and survey completed
15809604|NCT04370639|Other|Survey|Patients will be asked to complete a survey regarding device tolerability after completing their cesarean section.
15809605|NCT04370626|Procedure|Open Reducation and Internal fixation with either screw/k-wire|This trial will be the first Canadian wide multi-centre open-label randomized clinical trial to look at a specific sub-pattern of purely ligamentous injury at the level of the scapholunate articulation. All subjects in this group will have their scpaholunate ligament repaired using either k-wires or screws
15809607|NCT04370600|Drug|beta hydroxybutyrate (BHB) ester|Ketone supplementation given 3x/day (60mL per dose, or 22g BHB)
15809608|NCT04370600|Drug|Placebo|Denatonium benzoate + HVMN ketone placebo flavor mix + Stevia
15809609|NCT04370587|Biological|T3011|T3011 will be administered up to 4mL as an intratumoral injection given Q2W.
15809610|NCT04370587|Combination Product|T3011 + pembrolizumab|T3011 will be administered up to 4mL as an intratumoral injection in combination with intravenous pembrolizumab given Q3W.
15809662|NCT04370223|Biological|Ozone auto-hemotherapy|ozone auto-hemotherapy
15809663|NCT04370210|Behavioral|Questionnaires|Child of both groups enrolled, and their parents, must complete online questionnaires
15809664|NCT04370184|Procedure|Ultrasound guided Costoclavicular Brachial Plexus Block|Ultrasound images from patients scheduled for upper limb surgery under costoclavicular brachial plexus block (one kind of regional anesthesia) have been routinely collected at our institute. These images will be reviewed.
15809612|NCT04370561|Procedure|ORIF non-locking|Open reduction and internal fixation using 1/3 tubular plate
15809613|NCT04370561|Procedure|ORIF locking|Open reduction and internal fixation using active ankle polyaxial locking plate
15809614|NCT04370548|Drug|DARE-BV1clindamycin phosphate vaginal gel, 2%|One full applicator (5 g) of clindamycin phosphate vaginal gel, 2% (100 mg clindamycin) or placebo gel will be applied intravaginally as a single dose within 1 day of randomization.
15809615|NCT04370535|Device|cellulose|The subjects of group A and group C receive boxes containing placebo for supplementation for a total of 12 weeks.
15809616|NCT04370535|Device|PMA-zeolite|The subjects of group B and group D receive boxes containing PMA-zeolite for supplementation for a total of 12 weeks.
15809617|NCT04370509|Drug|Axitinib (VEGF-TKI)|Given PO
15809618|NCT04370509|Procedure|Cytoreductive Nephrectomy (CN)|Undergo CN
15809619|NCT04370509|Procedure|Metastasectomy (MET)|Undergo MET
15809620|NCT04370509|Biological|Pembrolizumab|Given IV
15809621|NCT04370496|Procedure|Minimally invasive surgery using endoscopic stapler|Radical hysterectomy by minimally invasive surgery (laparoscopic or robotic) will be done with the help of an endoscopic stapler in cutting and suturing the uterine cervix.
15809622|NCT04370483|Drug|Leflunomide|Gievn PO
15809623|NCT04370483|Other|Quality-of-Life Assessment|Ancillary studies
15809624|NCT04370457|Other|Administration of the MyPal ePRO system|Patients will be asked to complete self-report questionnaires at baseline, and every month for the first six months and at 12-month follow-up
15809625|NCT04370444|Device|Phallus Length Reducer|Phallus Length Reducer
15809626|NCT04370444|Other|Self-assessment of dyspareunia|Use of a vaginal insert to self assess dyspareunia
15809627|NCT04370431|Drug|TTYP01 single ascending doses|TTYP01 (30 mg edaravone tablet) will be orally administrated at single ascending doses of 60 mg, 120 mg, 180 mg and 240 mg (n=6 per dose)
15809628|NCT04370431|Drug|Placebo|Placebo control for Part A of the study
15809629|NCT04370431|Drug|TTYP01, 60 mg|TTYP01 oral tablets (30 mg edaravone per tablet)
15809630|NCT04370431|Drug|TTYP01, 120 mg|TTYP01 oral tablets (30 mg edaravone per tablet)
15809631|NCT04370431|Drug|Radicut® (ampoule), 30 mg|An intravenous dose of edaravone injection, containing 30 mg edaravone in a 20 mL ampoule, will be administered at a dose of 30 mg over 30 minutes
15809632|NCT04370431|Drug|Radicut® (bag) , 60 mg|An intravenous dose of edaravone injection, containing 30 mg edaravone in a 100 mL injection bag, will be administered at a dose of 60 mg over 60 minutes
15809633|NCT04370431|Drug|TTYP01, up to 120 mg|TTYP01 oral tablets (30 mg edaravone per tablet). The fixed oral dose level of TTYP01 will depend on the results obtained in Part B of the study (no more than 120 mg)
15809634|NCT04370418|Drug|short course chemo-radiation with 5-fluorouracil|neo-adjuvant short course chemo-radiation in locally advanced rectal cancer patients followed by delayed surgery
15809635|NCT04370405|Drug|YY-20394|YY-20394 tablets will be given daily for 28 days in 28-day cycles until there appears evidence of progressive disease, intolerable toxicity, or the subject discontinues from the study treatment for other reasons.
15809636|NCT04370392|Procedure|intraperitoneal local anaesthetic instillation|intraperitoneal anesthetic instillation (40 ml total volume containing bupivacaine 0.25) through the trocar at the subdiaphragmatic space in Trendelenburg's position for 5 min with intravenous infusion of 50 ml normal saline over 10 minutes.
15809637|NCT04370379|Drug|IBI302 (the first dose level)|q4week (3 injections) followed by PRN dosing
15809638|NCT04370379|Drug|IBI302 (the second dose level)|q4week (3 injections) followed by PRN dosing
15809639|NCT04370379|Drug|Aflibercept|2mg, q4week (3 injections) followed by q8week
15809640|NCT04370353|Dietary Supplement|Cocoa flavanols|Flavonoid-rich cocoa powder, containing 100mg total flavanols per 316mg.
15809641|NCT04370353|Dietary Supplement|Placebo supplement|Microcrystalline filler, containing 0mg total flavanols.
15809642|NCT04370340|Device|BabySlide|Application of BabySlide during vacuum-assisted births for perineal protection
15809643|NCT04370327|Other|Pain Free Exercise (PF)|Patients will exercise until the onset on claudication (1 on the rating scale)
15809644|NCT04370327|Other|Moderate Claudication Pain Exercise (MOD-P)|Patients will exercise until they experience moderate claudication pain (2 on the rating scale)
15809645|NCT04370327|Other|Maximal Claudication Pain Exercise (MAX-P)|Patients will exercise until they experience maximal claudication pain (4 on the rating scale)
15809646|NCT04370314|Other|Dental prosthetics|Implant-supported crowns
15809647|NCT04370301|Drug|Cyclophosphamide|Given IV
15809648|NCT04370301|Drug|JAK Inhibitor|Given PO
15809649|NCT04370301|Drug|Fludarabine|Given IV
15809650|NCT04370301|Biological|Recombinant Granulocyte Colony-Stimulating Factor|Given SC
15809651|NCT04370301|Drug|Melphalan|Given IV
15809652|NCT04370301|Drug|Mycophenolate Mofetil|Given PO
15809653|NCT04370301|Procedure|Peripheral Blood Stem Cell Transplantation|Given IV
15809654|NCT04370301|Drug|Tacrolimus|Given IV and PO
15809655|NCT04370301|Radiation|Total-Body Irradiation|Undergo TBI
15809656|NCT04370288|Drug|MCN (Methylene blue, vitamin C, N-acetyl cysteine)|A mixture of MCN will be injected to covid-19 patients.
15809657|NCT04370262|Drug|SOC + Intravenous Famotidine|Standard of Care treatment plus IV famotidine
15809658|NCT04370262|Drug|SOC + Placebo|Standard of Care treatment plus IV placebo
15809659|NCT04370249|Other|pulmonary ultrasound|pulmonary ultrasound on admission
15809660|NCT04370236|Drug|INB03|Patients will receive up to two once per week subcutaneous injections of 1mg/kg INB03
15809665|NCT04370171|Other|care modalities|For these patients the consultation has been postponed for 6 months. No specific intervention for this group of patient.
15809666|NCT04370171|Other|Teleconsultation either by phone or by computer consultation|Management of diabetic patients by telemedicine with a teleconsultation either by phone or by computer consultation
15809667|NCT04370158|Other|disease history|Clinical progression and prognosis of patients with interstitial lung diseases
15809668|NCT04370145|Drug|Sulperazon|moderate cholangitis patients were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.
15809669|NCT04370145|Drug|Teicoplanin|severe cholangitis patients were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.
15809670|NCT04370145|Drug|Meropenem Injection|cholangitis in control group were treated with these drugs for 7days,unless the patients were cured or must be changed the therapeutic.
15809671|NCT04370119|Diagnostic Test|Nasal swab|SARS-CoV-2 PCR
15809672|NCT04370119|Diagnostic Test|Serum testing|Anti-SARS-CoV2 S protein IgG ELISA, serological changes after SARS-CoV-2 vaccination
15809673|NCT04370106|Other|Social leg program|Usual care as described for the CG will also be provided to the IG. Wound healing measurement, therapeutic adherence measurement, wound recurrence measurement, and questionnaires will be provided by the institute's nurses. After baseline data collection (T0) and random allocation to the intervention group, this usual care will be enhanced by frequenting a social leg program.
15809674|NCT04370093|Drug|Pioglitazone 45 mg|45 mg/day- one pioglitazone tablet once daily throughout the 24 weeks of the study
15809675|NCT04370093|Behavioral|Weight Loss|Weight loss following the Group Lifestyle Balance Program based on the Diabetes Prevention Program that utilizes cognitive behavioral strategies (goal setting, problem solving, self-monitoring, stimulus control),and provides written education materials to support health and nutrition behavior changes for weight management and disease prevention.
15809676|NCT04370093|Other|Pioglitazone + Weight Loss|Pioglitazone + Weight loss following the Group Lifestyle Balance Program based on the Diabetes Prevention Program that utilizes cognitive behavioral strategies (goal setting, problem solving, self-monitoring, stimulus control),and provides written education materials to support health and nutrition behavior changes for weight management and disease prevention.
15809677|NCT04370080|Device|Silver Diamine Fluoride 38%|Dental caries arrest medication
15809679|NCT04370041|Device|Dokimos Plus aortic valve|Dokimos Plus aortic valve
15809680|NCT04370028|Drug|Divaza|Oral administration.
15809681|NCT04370015|Drug|Hydroxychloroquine|Health care workers at high risk of contracting SARS-CoV-2 randomized to this arm will be treated with oral hydroxychloroquine 400 mg twice a day (four 200 mg tablets) on day 1 followed by 400mg (two 200 mg tablets) once a week for 11 weeks.
15809682|NCT04370015|Drug|Placebo oral tablet|• Health care workers at high risk of contracting SARS-CoV-2 randomized to this arm will be treated with placebo twice a day (four tablets) on day 1 followed by 2 tablets once a week for 11weeks.
15809683|NCT04369989|Other|No intervention|No intervention
15809684|NCT04369976|Device|ARTIFICIAL GRAVITY COMBINED WITH EXERCISE|The passive control group will abstain from any exercise. Recordings of the participant's will include cardiovascular functioning cardiac output (CO), stroke volume (SV) mean arterial pressure (MAP) diastolic blood pressure (DBP), systolic blood pressure (SBP), and heart rate (HR), Electroencephalography ( EEG) as well as dynamic force and stance and muscle oxygenation. More specifically, after 6 training sessions (2 weeks), the centrifugation load will be increased and will be combined with either aerobic exercise (through an ergometer) or resistance training through elastic training bands. Functional connectivity and cortical-network features will be used by deep learning algorithms in order to define the optimal centrifuge training .
15809685|NCT04369963|Procedure|Esophagogastroduodenoscopy and Colonoscopy with Biopsies|Participants will have an esophagogastroduodenoscopy and colonoscopy with biopsies. Biopsies from esophagogastroduodenoscopy will not exceed 16 pinch biopsies, biopsies from colonoscopy will not exceed 16 pinch biopsies. Participants will have anesthesia for both procedures.
15809686|NCT04369950|Drug|2% lidocaine with 1:200,000 epinephrine and epidural morphine|Epidurals will be dosed with 2% lidocaine with 1:200,000 epinephrine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
15809687|NCT04369950|Drug|3% 2-chloroprocaine and epidural morphine|Epidurals will be dosed with 3% 2-chloroprocaine to T4 level in 5ml increments, epidural morphine 3mg will be given after delivery of neonate. T4 level maintained throughout cesarean delivery with additional epidural doses of 2% lidocaine with 1:200,000 epinephrine for both groups. This is the critical component to bridge the latency period between the offset of 3% 2-chloroprocaine and the peak action of epidural morphine.Post-operative orders of scheduled acetaminophen and ibuprofen, and oxycodone as needed will be written.
15809688|NCT04369937|Radiation|IMRT (Intensity Modulated Radiotherapy)|Radiation therapy
15809689|NCT04369937|Drug|Pembrolizumab|A potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between programmed cell death protein 1 (PD-1) and its ligands, PD-L1 and PD-L2.
15809690|NCT04369937|Drug|Cisplatin|Chemotherapy
15809691|NCT04369937|Biological|ISA101b|ISA101b is a therapeutic cancer vaccine that induces specific immune responses to the oncogenic E6 and E7 antigens from HPV16.
15809692|NCT04369924|Behavioral|Measurement-Based Care|Both study conditions will receive measurement-based care, which is the systematic, ongoing administration of assessment measures to support clinical decision-making.
15809693|NCT04369911|Procedure|Acupuncture|Acupuncture treatments will be separated by a minimum of two days and a maximum of 14 days. Treatment sessions will be identical for both groups. Standard, sterile stainless-steel, disposable needles will be inserted at acupuncture points with a total of 18 needles for each treatment session. The depth of the needle will be approximately 10-20 millimeters. Needles will be left in place for 30 minutes.
15809807|NCT04368910|Drug|Pyronaridine - artesunate|Oral pyronaridine artesunate (180:60 mg tablets), plus chloroquine-placebo once a day for 3 consecutive days.
15809694|NCT04369898|Other|Image analysis/ Central vein detection|Image analysis/ Central vein detection will be performed using a fully automated approach based on an ensemble of 3D convolutional neural Networks. The method is applied to T1w, T2w and T2*w data . Results will be manually reviewed by 2 experts in CVs detection. MRI data must have been collected at 3 Tesla (3T) between 1990 and 2020 and must include T1 w, T2 w, T2-star based sequence (CVs detection).
15809695|NCT04369898|Other|Image analysis/ Automatic cortical lesion detection|Image analysis/ Automatic cortical lesion detection will be performed by using a convolutional neural network-based method. MRI data must have been collected at 3T between 1990 and 2020 and must include Double inversion recovery (DIR)/Phase-Sensitive Inversion Recovery (PSIR)/Magnetization Prepared - 2- RApid Gradient Echo Gradient Echo (MP2RAGE) (eventually also high spatial resolution Magnetization Prepared - RApid Gradient Echo (MPRAGE)) for cortical lesion detection.
15809697|NCT04369872|Procedure|Microwave ablation|Microwave ablation of lung lesion using Solero Microwave Tissue Ablation system.
15809698|NCT04369859|Behavioral|Examine the impact of COVID-19 during pregnancy|clinical data collection
15809699|NCT04369846|Drug|GM-XANTHO onitment|Onitment application
15809700|NCT04369846|Drug|Placebo onitment|Onitment application
15809701|NCT04369833|Device|continuous glucose monitoring system|wearing continuous glucose monitoring device (iPro2 professional continuous glucose monitoring, MedtronicⓇ, California, USA)
15809702|NCT04369820|Other|draw blood|40 mL blood sample will be taken within the first three days of hospitalization, a second sample will be taken between the 5th and 10th day of hospitalization and a third sample will be taken on the 10th day of hospitalization or the day of discharge if earlier.
15809703|NCT04369807|Diagnostic Test|Outpatient MRI|"Participation in the study includes up to 3 visits to a partnering imaging facility - this will include measurement of height and weight (to calculate BMI), blood pressure measurement, 3 sets of blood tests, 3 Questionnaires and 3 MRI tests.
~There will be no medical interventions as part of the study. All participants will receive standard-of-care by their healthcare provider/s. With the participant's consent, the participant's primary care physician will be made aware of their participation in the study. Furthermore, participants will be informed of any structural abnormalities found in the MRI scan (e.g. abnormal vessels, haemangioma, tumour, cyst, among others) and abnormal blood test results as these may have clinical implications."
15809704|NCT04369794|Biological|BCG|0.1 ml of lyophilized, live and attenuated intradermal BCG vaccine, containing between 2 and 8 x 1.000.000 C.F.U in a single dose
15809705|NCT04369794|Biological|Placebo|0.9% saline in the same volume as the BCG vaccine in a single dose
15809706|NCT04369781|Diagnostic Test|transcutaneous oxygen pressure recording at rest|Recording of limb and chest transcutaneous oxygen pressure
15809707|NCT04369768|Procedure|restoration of permanent molars affected with MIH|restore MIH affected molars using direct composite or preformed metal crowns
15809708|NCT04369755|Other|MRI|A MRI in PTX mode will be done on healthy subject (approx. 90 min of sequences)
15809709|NCT04369742|Drug|Hydroxychloroquine (HCQ)|HCQ 400mg (2 tab) by mouth BID (day 1), 200mg (1 tab) by mouth BID (days 2-5)
15809710|NCT04369742|Other|Pacebo: Calcium citrate|Calcium citrate 2 tablets (400mg) BID on day 1, 1 tablet (200mg) on days 2-5
15809711|NCT04369716|Other|Whole oranges|Navel oranges (227 g total)
15809712|NCT04369716|Other|Whole Apples|Red Delicious apple with skin (230 g)
15809713|NCT04369716|Other|Orange juice + orange pomace|Orange Juice (149 g) + orange pomace (100g) [40% pomace by weight]
15809714|NCT04369716|Other|Apple juice + apple pomace|Apple Juice (129 g) + apple pomace (106 g) [45% pomace by weight]
15809715|NCT04369716|Other|Orange juice|Orange Juice (250 g)
15809716|NCT04369716|Other|Apple juice|Apple Juice (235 g)
15809717|NCT04369664|Drug|Statin|Participants will be given up to 80 mg oral tablets daily for the entire study period preferably at the same time each day.
15809718|NCT04369664|Drug|PCSK9 inhibitor|Participants will receive 2 injections of 140 mg of PCSK9 inhibitor, one will be administered at baseline visit and the other will be self-administered 2 weeks later at home.
15809719|NCT04369664|Drug|Ezetimibe 10mg|Participants who are not able to or not willing to take atorvastatin will be given 10 mg ezetimibe oral tablets daily for the entire study period preferably at the same time each day.
15809720|NCT04369638|Device|3D NAM|"After consent and birth of the child, a face MRI will be taken of the newborn before discharge from the hospital utilizing the feed and swaddle technique. The MRI will be sent to the dental team to convert into a format compatible with 3D software. With the image, a NAM appliance will be digitally fabricated and 3D printed. The 3D printed model will be tested for fit on stone model made from traditional impression. Both traditional NAM and 3D printed NAM will be inserted at delivery appointment. Fit will be assessed of both appliances by applying a try-in paste to the intaglio surface and counting the number of spots needing adjustment."
15809721|NCT04369638|Device|Traditional NAM|The patient will be seen for visit at the clinic for traditional intraoral impression and a dental stone model will be poured. An acrylic NAM will be fabricated on the stone model. The 3D printed model will be tested for fit on stone model made from traditional impression. Both traditional NAM and 3D printed NAM will be inserted at delivery appointment. Fit will be assessed of both appliances by applying a try-in paste to the intaglio surface and counting the number of spots needing adjustment.
15809722|NCT04369625|Behavioral|CHIMPS-T|CHIMPS-T (Children of mentally ill parents) is a family-oriented lowfrequency brief therapy for diagnosis and treatment of mental disorders in children and adolescents.
15809723|NCT04369625|Behavioral|CHIMPS-P-single|CHIMPS-P-single is a family-oriented prevention for children and adolescents without signs of mental disorders in the initial screening. These families will receive the 3 family sessions from the modular CHIMPS intervention.
15810400|NCT04364035|Drug|Placebo Oral Tablet|Unit-dose placebo tablet delivered as two 3-mg placebo tablets
15809724|NCT04369625|Behavioral|CHIMPS-P-group|The CHIMPS-P-group is a prevention with a multi-family setting based on the CHIMPS approach. The multi-family intervention comprises 8 sessions for children and adolescents without psychiatric disorders and their families.
15809725|NCT04369625|Behavioral|iCHIMPS|iCHIMPS is an online intervention. In terms of content, iCHIMPS is based on the CHIMPS program as well as on other evidence-based interventions of the study group. iCHIMPS will also be comprised of one module for children and adolescents as well as one module for parents; moreover; modules for the family system will be included.
15809726|NCT04369612|Procedure|Standard follow-up|Standard post-transplant follow-up
15809727|NCT04369612|Procedure|Home-based monitoring|Patients take capillary blood sample by finger-prick and send to lab for analyses. Telecom follow-up that day by treating physician
15809728|NCT04369599|Device|V/Q System|With the patient supine, sedated, and hemodynamically stable, the Vest is placed upon the patient and secured by clinicians and staff. All chambers of the Vest will be inflated simultaneously. First inflation will be for one hour to a pressure of 0.4 psi. Subsequent inflations at 0.8 and finally 1.2 psi will be performed for one hour each. Participants will be treated for up to four hours and then will be observed for an additional hour.
15809729|NCT04369586|Drug|meplazumab for injection|single dose: 6 dose level, multiple dose: 0.3mg/kg/dose
15809730|NCT04369586|Drug|Placebo|placebo
15809731|NCT04369573|Combination Product|Early intra-aortic balloon pump (IABP) implantation|IABP implantation within 6 hours since cardiogenic shock symptoms onset
15809732|NCT04369573|Other|Standard of care as vasoactive agent|Any agent (inotropes and vasopressors) will be allowed. However, the following guide is provided to increase uniformity: 1) vasopressors allowed will be either epinephrine or norepinephrine; 2) as inotropic agent milrinone or dobutamine or levosimendan could be used; 3) dopamine will be allowed in association with milrinone or dobutamine or levosimendan; 4) the maximum inotropic score allowed will be 20.
15809733|NCT04369560|Diagnostic Test|Magnetic Resonance Imaging|60-cm wide bore 3T scanner (Siemens AG, Erlangen, Germany) with a 32-channel pelvic phased-array coil placed over the bladder.
15809734|NCT04369560|Drug|Gadobutrol intravesical administration (4mM)|A paramagnetic macrocyclic gadolinium-based contrast agent administered intravenously for use in magnetic resonance imaging. Contrast-enhancement is a result of the neutral complex of gadolinium and dihydroxy-hydroxymethylpropyl- tetraazacyclododecane-triacetic acid (butrol).
15809735|NCT04369560|Drug|Ferumoxytol intravesical administration (5 mM)|An iron preparation (Fe3O4) approved for intravenous treatment of anemia in the setting of renal failure, comprised of superparamagnetic iron oxide nanoparticles which are coated by a semi-synthetic carbohydrate shell in an isotonic, neutral pH solution.
15809736|NCT04369547|Device|Transcranial Magnetic Stimulation|Single-pulse transcranial magnetic stimulation and theta-burst stimulation.
15809737|NCT04369547|Drug|Roflumilast|Roflumilast 250mcg
15809738|NCT04369547|Drug|Placebo oral tablet|Placebo capsule matched to roflumilast capsule
15809739|NCT04369534|Drug|Clopidogrel|Adjusting clopidogrel dosage according to platelet reactivity results during 12 months after PCI
15809740|NCT04369534|Drug|Ticagrelor|Administration of standard dose of ticagrelor during 12 months after PCI
15809741|NCT04369521|Other|low free sugar diet|low free sugar diet with nutrition and exercise recommendation
15809742|NCT04369508|Radiation|permanent brachytherapy|"Briefly, the patient had a general anesthesia and PPB was performed by using the real-time intraoperative planning method guided by TRUS. The radioactive seeds were inserted transperineally according to a modified peripherally loaded Seattle technique 17. I-125 was used for all implants with a mean seed activity of 0.45 mCi per seed. All procedures were completed by a single surgeon."
15809743|NCT04369495|Other|BAFF serum levels|BAFF levels in serum in visit 0,1,2 during induction therapy
15809744|NCT04369482|Device|Alcon Clareon|Implantation of an intraocular lens Alcon Clareon
15809745|NCT04369482|Device|Hoya Vivinex|Implantation of an intraocular lens Hoya Vivinex
15809746|NCT04369469|Biological|Ravulizumab|Weight-based doses of ravulizumab will be administered intravenously on Days 1, 5, 10, and 15.
15809747|NCT04369469|Other|Best Supportive Care|Patients will receive medications, therapies, and interventions per standard hospital treatment protocols.
15809748|NCT04369456|Other|blood sample|a blood sample is taken on Covid-19 kidney transplant patients with moderate symptoms
15809749|NCT04369443|Procedure|Large volume Acute Normovolemic Hemodilution|Following induction of anesthesia, the volume of blood to be removed during Acute Normovolemic Hemodilution was calculated using an established formula:V=Weight（Kg）×12-15（mL/Kg）;Blood to be removed was capped at： Vmax=EVB×(Hi-Hf)/Hav（EBV= estimated blood volume （male:70mL/Kg，female:65mL/Kg）；Hi= initial hemoglobin ；Hf=target Hb（ 10g/dL ）；Hav= the average of the initial and minimal allowable hemoglobin）.Ensure the volume of removed blood does not exceed the upper limit and Hb ≥10g/dL after blood removed.
15809750|NCT04369430|Drug|AKST4290|Oral AKST4290
15809751|NCT04369430|Drug|Placebo|Oral Placebo
15809752|NCT04369417|Behavioral|Relaxation Response Resiliency Program for Siblings of Children with ASD|Virtually delivered psycho-educational resiliency training program for teenage siblings of children with ASD.
15809753|NCT04369404|Behavioral|Pelvic organ prolapse decision aid|Paper-based educational tool to guide shared decision making conversations for treatment of pelvic organ prolapse
15809754|NCT04369404|Behavioral|Stress urinary incontinence decision aid|Paper-based educational tool to guide shared decision making conversations for treatment of stress urinary incontinence.
15809755|NCT04369404|Behavioral|Overactive bladder decision aid|Paper-based educational tool to guide shared decision making conversations for treatment of overactive bladder.
15809756|NCT04369391|Drug|SEP363856 150 mg|SEP363856 tablet 150 mg
15809757|NCT04369391|Drug|Placebo|Placebo tablet
15809758|NCT04369391|Drug|moxifloxacin 400 mg|moxifloxacin tablet 400 mg
15809808|NCT04368910|Drug|Chloroquine|Oral chloroquine (155 mg tablets), plus pyronaridine artesunate-placebo, once a day for 3 consecutive days.
15809809|NCT04368897|Diagnostic Test|CAG length <22|CAG repeat length in exon 1 of AR gene
15809810|NCT04368897|Diagnostic Test|CAG length >=22|CAG repeat length in exon 1 of AR gene
15809978|NCT04367298|Behavioral|Chronoprevention|Preventive measures will be focused on organizational, educational and behavioural elements related to older people and healthcare professionals
15809759|NCT04369378|Behavioral|Meditation app usage|Investigators will confirm eligibility of applicants, enroll participants in the study and provide an identification number for de-identification of the data, and provide a list of mental health resources to participants. Participants will then be sent a link to a Google Form for the pre-intervention survey, to be completed prior to first use of the mindfulness app. Participants will also be given access to the mindfulness app (Insight Timer), and instructed to use it for 10 min daily for 30 days. Two days before the end of the 30 day intervention period, participants will be sent a link to a Google Form for the post-intervention survey and will be asked to complete the survey within the next 3 days. Two months after the conclusion of the 30 day intervention period, participants will be sent a link to a Google Form for another post-intervention survey, and asked to complete it within 5 days.
15809760|NCT04369365|Drug|Azithromycin 500 milligram (mg) oral Tablet|weekly oral use
15809761|NCT04369365|Drug|Placebo|weekly oral use
15809762|NCT04369339|Other|Colposcopy|
15809763|NCT04369326|Other|Community-Based TPT Initiation|Community-based care delivery model for pediatric tuberculosis evaluation and initiation of preventive therapy
15809764|NCT04369313|Procedure|delayed cord clamping|umbilical cord clamping more than 30 seconds after birth
15809765|NCT04369313|Procedure|early cord clamping|umbilical cord clamping within 15 seconds after birth
15809766|NCT04369300|Behavioral|Registery Data Collection|Observational Data Collection
15809767|NCT04369274|Device|Mechanical ventilation with the automated BVM compressor|Mechanical ventilation is accomplished with a device that mechanically squeezes a manual bag valve instead of by hand. The rate and volume of compression are adjustable, and the device has appropriate alarms and safety features.
15809768|NCT04369261|Drug|Synovian®|Synovian® Inj.
15809769|NCT04369248|Other|hepassocin|hepassocin levels in polycystic ovary syndrome
15809770|NCT04369235|Device|tCES|The positions of the lesion side primary motor cortex were defined as C3/C4 according to the international 10-20 system of electroencephalograms. tCES will be applied for 20 minutes at an intensity of 1.0 -1.5 mA direct current stimulation and a specific-added waveform each time, 3 times a week, lasting for 6 weeks.
15809771|NCT04369235|Device|Sham tCES|The positions of the lesion side primary motor cortex were defined as C3/C4 according to the international 10-20 system of electroencephalograms. Sham tCES will consist of a 5-second ramp up to 1.0-1.5 mA direct current stimulation and a specific-added waveform followed immediately by a 5-second ramp down, no current in the middle 19 minutes 40 seconds, and a ramp-up and ramp-down period during the last 10 seconds.
15809772|NCT04369222|Other|Observational|Maternal consumption of mild analgesics
15809773|NCT04369170|Device|prosthesis connected directly to the implants|dental prostheses connected directly to the dental implants
15809774|NCT04369170|Device|Intermediate abutment|dental prostheses connected with an intermediate abutment to the implant
15809775|NCT04369157|Procedure|Elective surgery|Patients will be scheduled to undergo elective orthopaedic (knee/hip replacement) or colorectal surgery.
15809776|NCT04369144|Other|Dynamic Scapular Recognition exercise|The intervention group received continual vertical downward correction using a standardized rigid tape. A hypoallergenic tape (Hypafix; BSN Medical GmbH, Hamburg, Germany) was used with 50% to 75% tension. Two rigid tapes were applied; the first one is placed from just superior to the midpoint of the superior border of the scapula to the level of T12 and the second tapes were placed from just superior to the superior angle of the scapula to the level of T12. The level of T12 was used as the end of both taps to increase the lever arm of the applied force and to decrease the incidence of peeling off of the tape. No tape was applied from the lateral angle of the scapula because it might impair the upward rotation of the scapula. Both taps were performed after each session and removed immediately before the next session
15809777|NCT04369131|Device|Functional electrical stimulation|Randomized placement of FES pads in one of four locations during each session. Locations include: (a) none, (b) calves only, (c) quads and abdominals only, and (d) calves, quads, and abdominals.
15809778|NCT04369118|Procedure|Conventional follow-up|Patients in this group benefit from conventional post-operative follow-up
15809779|NCT04369118|Device|Conventional follow-up+chest wall restriction belt|Patients in this group benefit from conventional post-operative follow-up. The patient wear the selective chest wall restriction belt from Day 2 (after surgery) until he ceases to need it.
15809780|NCT04369105|Other|Prone position|The patients will be put in prone position while receiving invasive mechanical ventilation and the investigators will monitor changes in mechanical power applied to the respiratory system and compare with supine position
15809781|NCT04369092|Other|DYMUS|DYsphagia in MUltiple Sclerosis (DYMUS) that was questionnare and Eating Assessment Tool (EAT-10) were used for assess swallowing problem. All individuals were classified according to DYMUS. The DYMUS Score was 1 or 2 was taken as mild swallowing problems, 3 or more was taken as severe swallowing problems. Patients were divided into three groups; first group that include patients without swallowing problems, second group that include patients with mild swallowing problems, third group that include severe swallowing problems.
15809782|NCT04369079|Other|manual myofascial techniques|Fascial techniques were used together with the following techniques: deep massage of neck and shoulder girdle muscles; trigger point therapy; tissue scar treatment in the vicinity of the scar and directly on the scar, by stretching, breaking, pulling, as well as static and dynamic rolling; post-isometric relaxation (stretching) of shoulder and neck muscles; active release technique of the chest and shoulder; selected fascial distortion model techniques; and fascial manipulation techniques consisting of developing specific CC-center of coordination and CF-center of fusion points in the operated area and the shoulder on the same side.
15809783|NCT04369079|Other|conventional therapy consisting of exercise and massage.|Underwent kinesiotherapeutic procedures that included various floor gymnastic exercises with gymnastic stick, balls, and/or elastic tapes, conventional massage of neck and shoulder girdle muscles and therapeutic exercises to increase ROM in the upper limb and in the chest area.
15809840|NCT04368598|Drug|Dexamethasone|Dexamethasone, iv, 40 mg/d, for 4 days (The 4-day course of dexamethasone was repeated on days 11 to 14 in the case of lack of response by day 10)
15809841|NCT04368598|Drug|Acetylcysteine|Acetylcysteine, po, 400mg tid, for 4 weeks
15809842|NCT04368585|Drug|Tebipenem pivoxil hydrobromide (TBPM-PI-HBr)|Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) 600 mg single-dose given orally.
15810159|NCT04365881|Other|Cross-sectional observational study|Survey
15809784|NCT04369066|Diagnostic Test|Blood samples (collection of 5 mL of blood in a dry tube)|"A nurse will take blood samples under safe conditions compatible with the pandemic period and while respecting the protection of the volunteer's personal data.
~The blood samples will be taken at 4 times for Institute Curie and Institute Pasteur: T0, between 6 weeks and 3 months ,6 months and 12 months post-inclusion.
~For volunteers already included at Institute Curie : in case of proved (RT-PCR+ or antigenic +) or very likely (anosmia and/or ageusia, and/or digestive syndrome with associated respiratory signs) between 2 sampling times already planned in the flow chart, blood samples shall be performed, if time since last planned sampling(s) has been more than 3 weeks or if time until next sampling(s) is more than 3 weeks.
~The serum samples will be extracted and collected prospectively from the blood samples.
~For each blood sample, a sample number will be assigned by the laboratory management system of the Department of Biology at Institut Curie."
15809785|NCT04369066|Diagnostic Test|Nasopharyngeal swabs|"The nasopharyngeal swabs will be performed between 6 weeks and 3 months, 6 months and 12 months post-inclusion for Institute Curie staff with at least one of the following criteria: have had RT-PCR+, and/or presence of antibodies at the 95% threshold, and/or anosmia/ageusia, and/or digestive syndrome with associated respiratory signs.
~The nasopharyngeal swab shall also be proposed to volunteers not meeting the above listed criteria to have a control group (about 100 volunteers).
~For volunteers already included at Institute Curie : in case of proved (RT-PCR+ or antigenic +) or very likely (anosmia and/or ageusia, and/or digestive syndrome with associated respiratory signs) infection between 2 sampling times, nasopharyngeal swabs shall be performed if time since last planned sampling(s) has been more than 3 weeks or if time until next sampling(s) is more than 3 weeks.
~The nasopharyngeal swabs will be performed at T0 for Institute Pasteur staff so 4 times in total."
15809786|NCT04369053|Diagnostic Test|Freenome test|Participants who provide informed consent, meet the eligibility criteria and provide a blood sample for this study will be enrolled. Participants will undergo blood collection and will then complete a standard-of-care screening colonoscopy.
15809787|NCT04369040|Device|High-flow nasal oxygen therapy using a specific nasal cannula|Patient in this arm will received high-flow nasal oxygen therapy ventilation during the ENT surgery
15809788|NCT04369040|Device|Flow Controlled Ventilation using a laryngeal tri-tube|Patient in this arm will received a laryngeal tri-tube ventilation during the ENT surgery
15809789|NCT04369027|Diagnostic Test|passive leg raising|"passive leg raising: to raise the legs of the patients by adjusting the angle of the patient's bed during one minute.
~Tidal volume challenge: an increas by 2ml/Kg of the tidal volume during one minute"
15809790|NCT04369014|Drug|etomidate anesthesia|etomidate is used for induction and maintenance of general anesthesia
15809791|NCT04369014|Drug|propofol anesthesia|propofol is used for induction and maintenance of general anesthesia
15809792|NCT04369001|Behavioral|Community-Based Exercise|Participants will complete 150 minutes of exercise per week for 12 weeks. Exercise per week will be documented using exercise logs. The exercise protocol will be a culturally-tailored community-based exercise intervention based on the aerobic exercise goals used in the Program ACTIVE study and psychoeducational materials adapted from Program ACTIVE based on feedback from Black men with T2D. Exercise in Program ACTIVE will be obtained through individualized community-based activities that participants in the focus groups indicate as feasible rather than the highly controlled laboratory environment. Exercise goals will be adapted to accommodate the physical and medical restrictions of an older-adult diabetes population.
15809793|NCT04369001|Behavioral|Cognitive Behavioral Therapy|Participants will receive 10 sessions of CBT using a manualized approach based on Beck's model of cognitive therapy. Sessions are to be completed once weekly in conjunction with weekly exercise. The Program ACTIVE CBT intervention includes: presentation of CBT model; thought records, cognitive distortions, counterarguments, cognitive reframing, automatic thoughts, core beliefs, and relapse prevention. Session goals will be tailored to the needs of men so that the order of topics may vary. Each session will begin with the designation of session goals, review of previously assigned homework, and introduction of new concepts and skills. Individually-tailored homework assignments designed to provide practice with the concepts/skills of the session will be assigned.
15809794|NCT04368988|Biological|SARS-CoV-2 rS - Phase 1|Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS (0.6 mL) on Days 0 and 21.
15809795|NCT04368988|Biological|SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 1|Alternating intramuscular (deltoid) injections of SARS-CoV-2 rS mixed with Matrix-M adjuvant (0.6 mL) on Days 0 and 21.
15809796|NCT04368988|Other|Normal saline solution (NSS), Placebo - Phase 1|Alternating intramuscular (deltoid) injections of placebo (0.6 mL) on Days 0 and 21.
15809797|NCT04368988|Other|Normal saline solution (NSS), Placebo - Phase 2|Intramuscular (deltoid) injections of placebo (0.5 mL).
15809798|NCT04368988|Biological|SARS-CoV-2 rS/Matrix-M Adjuvant, Day 0 - Phase 1|Intramuscular (deltoid) injection of SARS-CoV-2 rS mixed with Matrix-M adjuvant (0.6 mL) on Day 0.
15809799|NCT04368988|Other|Normal saline solution (NSS), Placebo, Day 21 - Phase 1|Intramuscular injection of placebo (0.6 mL) in alternate deltoid on Day 21.
15809800|NCT04368988|Biological|SARS-CoV-2 rS/Matrix-M Adjuvant - Phase 2|Intramuscular (deltoid) injections of SARS-CoV-2 rS co-formulated with Matrix-M adjuvant (0.5 mL).
15809801|NCT04368949|Other|Stepping-Up|The intervention group will receive STEPPING-UP, a virtual 12-week, multicomponent intervention that includes tailored task-oriented motor learning exercise and a mobility self-management (SM) program.
15809802|NCT04368949|Other|Telephone-Based Coaching Walking Program|The participants assigned to this group will receive a 12-week Telephone-Based Coaching Walking Program (TELE) delivered by a PT who will help participants set short and long term walking goals.
15809803|NCT04368949|Other|Chair-Based Yoga Program|Participants assigned to this group will receive a virtual 12-week Chair-Based Yoga Program (YOGA), a group-based exercise control where participants will undertake a seated exercise program that includes: warm up, seated and standing yoga poses, cool down.
15809805|NCT04368923|Device|Oxygen Therapy|Patients receive oxygen therapy
15809806|NCT04368923|Procedure|Physical Therapy|Patients receive physical therapy
15810160|NCT04365868|Drug|belapectin|intravenous
15809811|NCT04368858|Diagnostic Test|Exploratory physiopathology study, including non-invasive functional explorations carried out in patients with chronic pathology.|In the Mobility Exploration Unit of the University Hospital of Clermont-Ferrand, patients with chronic illnesses undergo a complete assessment of their physical capacities as well as their nutritional status. For the purpose of this protocol, patients will have to perform 2 functional tests, namely the TM6 and the TUG, while being equipped with inertial sensor units (mTUG® and mGAIT®). The data of the gait analysis, posturography and strength analyses as well as the questionnaires' scores will be taken into account in this research. At 6 months and at 1 year, occurrence of a fall will be recorded in order to prospectively monitor this parameter.
15809812|NCT04368845|Device|Telerehabilitation|The treatment arm will be given up to 1-hour breathing exercises, aerobic and resistive training exercises administered by a physiotherapist via a telerehabilitation device every 10 days for a six-month period.
15809813|NCT04368832|Other|Remote consultation|One or more consultation is conducted by phone or teleconsultation during prenatal monitoring
15809814|NCT04368819|Drug|Allopurinol 300 MG|Allopurinol 300mg once daily for four weeks followed by allopurinol 300mg twice daily for 12 weeks
15809815|NCT04368819|Drug|Placebo oral tablet|Placebo 300mg once daily for four weeks followed by allopurinol 300mg twice daily for 12 weeks
15809816|NCT04368806|Drug|JointStem|Autologous Adipose tissue derived Mesenchymal Stem Cells (AdMSC)
15809817|NCT04368806|Other|Placebo Control|Normal Saline with autologous Serum
15809818|NCT04368793|Behavioral|Remote pulmonary rehabilitation|The pulmonary rehabilitation intervention includes respiratory exercise, barehanded aerobic training, exercise prescription of elastic band impedance training, respiratory muscle strength training, etc.
15809819|NCT04368780|Other|Effect of Progressive Muscle Relaxation Combined With Music|The CD on relaxation exercises developed by the Turkish Psy-chological Associationwas used.In the second of CD 30-min section; relaxation exercises are explained to the accompaniment ofrunning water sounds and verbal instructions. Progressive relaxation technique includes stretching and relaxing the bigmuscle groups (hands, arms, neck, shoulders, face, chest, abdomen,hip, feet andfingers) in the human body on purpose. When steps ofProgressive Relaxation Exercises are analyzed, it is observed thatlearning how to take correct and deep breaths is the most impor-tant step towards learning relaxation. In addition, taking correct breaths is used as a part of the exercise among all relaxation exercises.Steps of Progressive Relaxation Exercise:- breathing exercises- lower extremity exercises- upper extremity exercises- exercise of respiratory muscles.
15809820|NCT04368767|Behavioral|Skin-to-skin|Skin-to-skin contact will be performed for two hours daily for three consecutive days in the first week of life, usually in the afternoon. This time interval will allow all pre-intervention sample collection to begin 1 hour after the infant's feeding schedule in the afternoon. After pre-intervention measures of axillary temperature, heart rate, respiratory rate, and oxygen saturation by pulse oximetry (SPO2) are obtained; cotton balls placed in the diaper for urine collection will be removed and stored in an appropriate container. Salivary oxytocin and cortisol will be collected per protocol below. Mothers will be requested to sit in reclining chairs with a front opened blouse or hospital gown. Infants will be removed from the incubator and placed naked except for a diaper and hat directly onto the skin between the mother's breasts and covered with a blanket. All infants will be monitored. After the two hours of SSC is completed, the infant will be returned to the incubator.
15809821|NCT04368754|Other|Questionnaire|Patients evaluated with different questionnaire.
15809822|NCT04368741|Dietary Supplement|SANZ®KINGWILL|20g nutrition product (SANZ®KINGWILL) was used as extra meal at 10:00am and 15:00pm, respectively.
15809823|NCT04368741|Dietary Supplement|GLUCERNA SR®|17.5g nutrition product (GLUCERNA SR®) was used as extra meal at 10:00am and 15:00pm, respectively.
15809828|NCT04368715|Device|Laser-assisted frenectomy with 2780 nm Er:Cr;YSGG and 940 nm diode laser|
15809829|NCT04368702|Radiation|Viewray MRIdian® Linac|MR-image guided radiation will be administered per disease site standards.
15809830|NCT04368689|Other|Floatation-based reduced environmental stimulation therapy|Completion of 3 float session that can last for up to 90 minutes each session, each spaced approximately one week apart
15809831|NCT04368676|Other|Sudarshan Kriya Yoga (SKY)|The SKY program is a standardized, easy to learn sequential breathing yoga consisting of regulated breathing techniques followed by a timed rhythmic breathing practice. Participants will learn various exercises including rhythmic breathing, gentle yoga, and guided meditation.
15809832|NCT04368676|Other|Health Enhancement Program|HEP is a structured group program designed to help participants with information and instruction how to lead a healthier life. Participants will be provided psychoeducation and support regarding healthy active living using techniques like music therapy, diet control, exercise, and monitoring these via journaling.
15809833|NCT04368663|Drug|Japanese traditional medicine group|TJ-134 (7.5g/day) or lactomin (3g/day) is administered for 8 weeks.
15809834|NCT04368650|Drug|BMP-2|lyophilized Human Bone Morphogenetic Protein-2 was used as an active drug.
15809835|NCT04368650|Procedure|PRF|For the preparation of sticky bone, the patient's venous blood is collected and centrifuged at 2400rpm for 2min which leads to two different layers in the vacutainer the upper autologous fibrin glue (AFG) and the lower RBC portion, the upper AFG is mixed with a particulate bone graft (hydroxyapatite). Within 5-10 min fibrin meshwork was formed
15809836|NCT04368624|Other|Skin Tape|Skin sample collection: samples of human stratum corneum will be obtained with squame adhesive tape disks typically at the time of their clinic appointment. The tape will be placed on the inside of the forearm and the procedure will be repeated up to five times per patient to have sufficient corneocytes for analysis. This type of sampling is non-invasive.
15809837|NCT04368624|Diagnostic Test|Blood Draw|Blood specimens: blood will be obtained for serum amino acids/phenylalanine levels. This sample is obtained for disease monitoring as part of routine standard of care. Results from up to three clinic visits will be correlated with the tape sample obtained on the same day.
15809838|NCT04368611|Procedure|start with fundus|fundus first dissection then complete cholecystectomy as usual
15809839|NCT04368611|Procedure|calot first dissection|start dissection by calot approach
15809843|NCT04368585|Drug|20 mL aluminum hydroxide/magnesium hydroxide/simethicone (400 mg aluminum hydroxide/400 mg magnesium hydroxide/40 mg simethicone per 5 mL)|20 mL aluminum hydroxide/magnesium hydroxide/simethicone (400 mg aluminum hydroxide/400 mg magnesium hydroxide/40 mg simethicone per 5 mL) oral suspension.
15809844|NCT04368585|Drug|Omeprazole|40 mg (1 x 40 mg capsule) omeprazole administered QD
15809845|NCT04368572|Behavioral|Hypnosis|"An interview assesses the patient's level of anxiety, interests and dissociative abilities. Hypnosis is done by following the steps:
~First step: reception and installation of the patient Second step: induction phase Third step: hypnotic trance phase Fourth step: reorientation phase"
15809846|NCT04368559|Drug|Rezafungin for Injection|Intravenous antifungal therapy
15809847|NCT04368559|Drug|Posaconazole|Oral antifungal therapy
15809848|NCT04368559|Drug|Fluconazole|Oral antifungal therapy
15809849|NCT04368559|Drug|Trimethoprim-sulfamethoxazole (TMP/SMX)|Oral antibacterial therapy
15809850|NCT04368559|Drug|Intravenous Placebo|Normal saline
15809851|NCT04368559|Drug|Oral Placebo|Microcrystalline cellulose
15809852|NCT04368546|Drug|Sunitinib|
15809853|NCT04368533|Other|Livionex Dental Gel|The subjects will brush their teeth with Livionex Dental Gel twice a day for 9 months.
15809854|NCT04368533|Other|A standard children's toothpaste containing 1500 ppm fluoride|The subjects will brush their teeth with a standard children's toothpaste containing 1500 ppm fluoride twice a day for 9 months.
15809855|NCT04368520|Dietary Supplement|Vitamin D3|800 IU Fultium-D3, cholecalciferol (Internis), given daily for 3 months
15809856|NCT04368520|Dietary Supplement|Vitamin D3|3,200 IU Fultium-D3, cholecalciferol (Internis), given daily for 3 months
15809857|NCT04368520|Other|Placebo|Hypromellose capsules, given daily for 3 months
15809858|NCT04368507|Drug|YYB101|"b (Dose level 0 cohort): YYB101 20mg/kg, Irinotecan 150 mg/m2 of each dose level, IV infusion on Day 1, Day15, and followed by every 2 weeks until disease progression or unacceptable toxicity
~a Stage 1: YYB101 RP2D, Irinotecan 150 mg/m2 of each dose level, IV infusion on Day 1, Day15, and followed by every 2 weeks until disease progression or unacceptable toxicity"
15809859|NCT04368494|Behavioral|12-week home based exercise|Patients allocated to the exercise arm will be prescribed a home-based walking exercise programme consisting of 30 minutes of walking on 5 days per week at an RPE in the range of 12-14 (somewhat hard). Each patient's heart rate range will be established during the baseline exercise test by recording the heart rate response at the required RPE target range. This will be provided to each patient to use in conjunction with the activity monitor they will be given to wear on their non-dominant wrist. The monitor reports heart rate and records daily steps, distance and activity duration.
15809860|NCT04368468|Other|biomarker evolution|analysis of a list of biomarkers on triple negative breast tumors samples before and after neoadjuvant therapy
15809863|NCT04368429|Biological|Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine (MenACYW Conjugate Vaccine)|Pharmaceutical form: Liquid solution Route of administration: IM
15809864|NCT04368429|Biological|Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine|Pharmaceutical form: Liquid solution Route of administration: IM
15809865|NCT04368403|Drug|KHK4827|210 mg every 2 weeks (Q2W), subcutaneous (SC) injection
15809866|NCT04368377|Drug|Tirofiban Injection|Patients will receive 25 microgram per kilogram of body weight tirofiban as bolus IV injection (3 minutes) followed by continuous infusion at a rate of 0,15 microgram/kg//minute for 48 hours.
15809867|NCT04368377|Drug|Clopidogrel|Patients will receive a loading dose of clopidogrel 300 mg PO, followed by 75mg daily for 30 days
15809868|NCT04368377|Drug|Acetylsalicylic acid|Patients will receive acetylsalicylic acid 250 mg IV before starting tirofiban, and this will be continued at a dose of 75mg daily for 30 days.
15809869|NCT04368377|Drug|Fondaparinux|Patients will receive concurrent fondaparinux 2.5mg s/c per day for the duration of the in hospital stay
15809870|NCT04368364|Drug|Intrathecal morphine sulfate (ITM)|Spinal anesthesia with ITM + US guided QLB single shot sham block + QLB catheters with no continuous infusion
15809871|NCT04368364|Drug|Bupivacaine hydrochloride|Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters with no continuous infusion
15809872|NCT04368364|Drug|ropivacaine hydrochloride|Spinal anesthesia without ITM + US guided QLB single shot with bupivacaine hydrochloride + QLB catheters continuously infusing 0.2% ropivacaine hydrochloride
15809873|NCT04368351|Dietary Supplement|SivoMixx (200 billion)|Composition of SivoMixx: Streptococcus thermophilus DSM322245, Bifidobacterium lactis DSM 32246, Bifidobacterium lactis DSM 32247, Lactobacillus acidophilus DSM 32241, Lactobacillus helveticus DSM 32242, Lactobacillus paracasei DSM 32243, Lactobacillus plantarum DSM 32244, Lactobacillus brevis DSM 27961 (NB: DSM n°... : bacterial strain identification code)
15809874|NCT04368351|Drug|Azithromycin|dose: 500mg 1 cp / day (alternatively lopinavir/ritonavir cps 200/50 mg, 2 cps x 2 / day or darunavir 800 mg 1 cp / day + ritonavir 100 mg 1 cp / day or darunavir/cobicistat 800/150 mg 1 cp / day)
15809875|NCT04368351|Drug|hydroxychloroquine|dose: 200 mg, 1 cp x 2 / day
15809876|NCT04368338|Diagnostic Test|COVID-19 RT-PCR|Polymerase chain reaction tests after reverse transcription for the detection of viral Covid-19 RNA (RT-PCR)
15809877|NCT04368338|Procedure|lung ultrasound|lung ultrasound is standard practice to diagnose acute respiratory failure in Emergency room
15809878|NCT04368325|Diagnostic Test|Serum creatinine levels|Comparison of treatment length using mechanical ventilaton, length of stay in ICU, survival between two groups
15809879|NCT04368312|Other|No intervention|No intervention, just of questionnaire including validated tests
15809880|NCT04368299|Other|Telemedicine|Videoconferencing for follow-up
15809881|NCT04368299|Other|Standard care|Standard in-person outpatient follow-up
15809942|NCT04367584|Other|Clinical and laboratory examination|Clinical and laboratory examination (follicular content of acne lesions were obtained for fungal microscopic examination and fungal culture)
15810161|NCT04365868|Drug|Placebo|intravenous
15809882|NCT04368286|Behavioral|pulmonary rehabilitation|Pulmonary rehabilitation (respiratory rehabilitation) is a comprehensive intervention based on a comprehensive patient assessment, targeted to the treatment of patients, including but not limited to exercise training, education and behavior change, aimed at improving the physical and mental health of patients with chronic respiratory diseases and promoting long-term adherence to health-enhancing behaviors.
15809883|NCT04368273|Drug|PD-1 antibody|a new treatment drug combined radical radiotherapy concurrent chemotharpy
15809884|NCT04368260|Device|Control swab|FDA-cleared nasopharyngeal swab
15809885|NCT04368260|Device|Prototype swab|Injection molded polypropylene flocked nylon nasopharyngeal swab
15809886|NCT04368247|Diagnostic Test|Skin Fluorescent Imaging|Application of reagents, then imaging and scoring
15809887|NCT04368208|Other|Assessment of postnatal depression using the the Edinburgh questionnaire between 4 and 6 weeks after delivery|The Edinburgh questionnaire is a self questionnaire validated for postnatal depression between 4 and 6 weeks postnatal
15809888|NCT04368195|Procedure|Erector spinae block|Erector Spinae Plane Block (ESPB) - first recently described for the treatment of thoracic neuropathic pain, is a peri-paravertebral regional anesthesia technique that has since been reported as an effective technique for prevention of postoperative pain in various surgeries (10-12). In ESPB, local anesthetic is reported to be administered in to the interfascial plane between the transverse process of the vertebra and the erector spinae muscles, spreading to multiple paravertebral spaces.
15809889|NCT04368182|Biological|Autologous C-TCR055|Autologous C-TCR055 administered by intravenous (IV) infusion
15809890|NCT04368169|Dietary Supplement|Teramune Botanical Extract|Combination blend of aromatic plant extracts in an emulsifier carrier.
15809891|NCT04368169|Other|Placebo|Emulsifier carrier without active supplement ingredients.
15809892|NCT04368156|Device|gammaCore® (Vagus nerve stimulation)|Vagus nerve stimulation using the gammacore neurostimulation device
15809893|NCT04368130|Behavioral|SIGNAL|"SIGNAL is a smartphone-based mobile health intervention designed to improve important outcomes in cancer patient patients (e.g., symptom burden, physical functioning).
~Patients will download the adapted Beiwe app for a 6-month period and investigators will collect passive smartphone sensor data and active PRO data bi-weekly."
15809894|NCT04368117|Behavioral|Physical Therapy|Directed and prescribe physical therapy program for severely burned patients
15809895|NCT04368104|Diagnostic Test|Darwish test (office hysteroscopic bubble suction and tubal peristalsis)|Testing Darwish test (office hysteroscopic bubble suction test and proximal tubal peristalsis) in women using minipills versus other cases not using hormones..
15809896|NCT04368091|Device|Xtreme Touch - Neo sirolimus coated PTA balloon catheter|The Xtreme Touch (Magic Touch PTA) - Neo Sirolimus PTA Balloon Catheter is the world's first sirolimus coated PTA balloon. The purpose of the X-TOSI all-comers registry is to collect short and long-term clinical performance data on the Xtreme Touch (Magic Touch PTA) -Neo sirolimus PTA balloon catheter in the treatment of atherosclerotic disease in the infrainguinal arteries in an all-comers patient population in real world daily clinical practice.
15809897|NCT04368078|Drug|Toripalimab plus Lenvatinib|"Toripalimab 240mg, every 3 weeks, intravenous infused, day 1, 6 weeks a cycle. Lenvatinib 8mg (weight<60kg) or 12mg (weight≥60kg), once a day, oral at least 38 days of each 6 weeks cycle, day 2.
~Number of cycle: until progression or unacceptable toxicity events develop"
15809898|NCT04368052|Diagnostic Test|Mini Mental Test (MMT), S-100 beta, Neuron specific enolase and Glial fibrillary acidic protein|Patients undergoing liver transplantation (LTx) were measured using the Mini Mental Test (MMT) whereas simultaneous neuronal damage was evaluated through the measurement of S-100 beta (S100β), Neuron specific enolase (NSE) and Glial fibrillary acidic protein (GFAP) levels.
15809899|NCT04368039|Device|Normobaric Oxygen|40% FiO2 for 4 weeks
15809900|NCT04368039|Device|Placebo|21% FiO2 for 4 weeks
15809901|NCT04368026|Other|No intervention (survey study for medical doctors).|No intervention
15809902|NCT04368013|Procedure|Extended sampling and procedures|The study patients will give additional blood samples and also urine and faeces samples. Spirometry and additional biometric controls will be performed regularly. Necrobiopsies of various organs from deceased patients will be secured and stored for immunohistological and virological analysis.
15809903|NCT04368000|Behavioral|Intermittent prone positioning instructions|Participants will be given instructions to lie in the prone position for a duration of 1-2 hours, every 4 hours while awake.
15809904|NCT04368000|Behavioral|Usual care positioning with no instructions|Participants will not be given instructions to lie in the prone position for any duration.
15809905|NCT04367987|Diagnostic Test|Heart Rate Variability|Heart rate and RR interval Post-anonymized analysis of heart rate variability using the KUBIOS software
15809906|NCT04367948|Diagnostic Test|18F-FDG and 68Ga-NOTA-FAPI04 PET/CT|Each subject receive a single intravenous injection of 18F-FDG and 68Ga-NOTA-FAPI04, and undergo PET/CT imaging within the specified time
15809907|NCT04367948|Diagnostic Test|18F-FDG and 18F-NOTA-FAPI04 PET/CT|Each subject receive a single intravenous injection of 18F-FDG and 18F-NOTA-FAPI04, and undergo PET/CT imaging within the specified time
15809908|NCT04367935|Drug|Pentoxifylline|Pentoxifylline tablets 400mg three times daily for 2 months
15809909|NCT04367922|Behavioral|Positive Emotion Skills Course|The skills will be delivered over approximately 6 weeks, and individuals can participate from any device and location with internet access. A week will consist of 1-2 days of didactic material and 5-6 days of real-life skills practice and reporting. Participants cannot skip ahead, and can only progress to the next lesson if they have completed the current one, but they can return to old lessons or exercises if they wish to. Skills include: positive events, capitalizing, gratitude, mindfulness, positive reappraisal, personal strengths, achievable goals, self-compassion.
15809910|NCT04367909|Drug|Nimotuzumab|Nimotuzumab will be administered intravenously at a fixed dose of 200 milligrams (mg) on Day 1 of each 21-day cycle.
15809911|NCT04367909|Drug|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) will be administered intravenously on Day 1 of each 21-day cycle.
15809912|NCT04367909|Drug|Carboplatin|Carboplatin AUC 5 will be administered intravenously on Day 1 of each 21-day cycle.
15809972|NCT04367337|Other|No intervention|Observational data collection only, accounting for COVID-19 morbidity and mortality levels within each country
15809973|NCT04367324|Device|Low-level laser therapy|The low-level laser was applied to each patient in low-level laser therapy group.
15809913|NCT04367896|Other|Survey Group|"The survey sought to elucidate equity principles that are influencing transplant decision making. The group of respondents included solid organ transplant doctors (surgeons, referring doctors, transplant physicians, transplant coordinators, ICU transplant doctors), COVID-doctors (ICU doctors, Infectious Disease Doctors, Pulmonologists, Internists), and Ethicists with experience of transplant related issues.
~Respondent identification:
~A. The e-mail addresses of corresponding authors from Scopus January 1, 2017 and march 20, 2020:
~All (surgery) AND subj (medi) and key (transplantation), All (critical care) AND subj (medi) and key (transplantation), All (ethics) AND subj (medi) and key (transplantation). B. Emailing through the mailing list of scientific societies. C. The link to the survey published online. D. The link to the survey circulated through personal contacts and via social media sites."
15809914|NCT04367883|Drug|ACE inhibitor|If evolution is favorable in patients treated with ACE as assessed at the first step of the study, this treatment would be added in a random selection of new admitted patients suffering Covid19, and results would be compared to a control group of admitted patients.
15809915|NCT04367883|Drug|ARB|If evolution is favorable in patients treated with ARB as assessed at the first step of the study, this treatment would be added in a random selection of new admitted patients suffering Covid19, and results would be compared to a control group of admitted patients.
15809916|NCT04367857|Other|COVID-19 Serology|Quantitate Serology enzyme-linked immunosorbent assay (ELISA) for COVID-19
15809917|NCT04367857|Behavioral|Health Care Worker Survey|The purpose of this survey is to assess how healthcare workers are experiencing and coping with the COVID-19 crisis.
15809918|NCT04367831|Drug|Enoxaparin Prophylactic Dose|"Prophylactic dose anticoagulation (per Columbia University Irving Medical Center (CUIMC) Guidelines):
~If eGFR ≥30 mL/min (stable kidney function):
~BMI < 40 kg/m2: Enoxaparin 40 mg SC daily
~BMI 40 - 50 kg/m2: Enoxaparin 40 mg SC q12h
~BMI > 50 kg/m2: Enoxaparin 60 mg SC q12h"
15809919|NCT04367831|Drug|Heparin Infusion|Unfractionated heparin infusion at 10 units/kg/hour with goal anti-Xa 0.1 -0.3U/mL.
15809920|NCT04367831|Drug|Heparin SC|Unfractionated heparin at 5000-7500 units subcutaneous (SC) every 8 hours.
15809921|NCT04367831|Drug|Enoxaparin/Lovenox Intermediate Dose|If estimated glomerular filtration rate (eGFR) ≥ 30 mL/min: enoxaparin 1mg/kg subcutaneous (SC) daily.
15809922|NCT04367818|Procedure|Peri-anal local anaesthetic infiltration|postoperative pain relieve, among pediatrics patient
15809923|NCT04367818|Procedure|Caudal anaesthesia|Regional anaesthesia for postoperative pain relieve, among pediatrics patient
15809924|NCT04367805|Diagnostic Test|nasopharyngeal Covid 19 RT-PCR|nasopharyngeal Covid 19 RT-PCR
15809925|NCT04367766|Procedure|Prosthetically driven implant placement|Insertion of an osseointegrated implant into the bone of anterior maxilla/mandible, following the right prosthetic plan
15809926|NCT04367740|Diagnostic Test|To assess for development of IgG antibodies against SARS-CoV2|Swabs will be collected to assess for COVID-19 if PPE supplies allow.
15809927|NCT04367727|Device|Light emitting diode|Light emitting diode at a wavelength of 890 nm is produced by an array of 60 gallium aluminum arsenide light-emitting diodes located on flexible pads and the near infrared photo energy is delivered in a noninvasive, drug-free manner
15809928|NCT04367701|Diagnostic Test|Hemolysis|Authors measured free plasma hemoglobin concentration in gram
15809929|NCT04367688|Drug|Tenofovir Disoproxil Fumarate 300 mg / emtricitabine 200 mg|daily use for PrEP
15809930|NCT04367675|Drug|INO-5401|INO-5401 contains genes which are active in human cancers (hTERT, PMSA, and WNT1) and are felt to be good targets for the immune system both people who have had cancer or for those at increased risk of getting cancer.
15809931|NCT04367675|Drug|INO-9012|INO-9012 contains the gene for IL12, a part of your body's immune system. It is possible that adding this to INO-5401 will increase the immune response to the vaccine.
15809932|NCT04367675|Device|Cellectra 2000|The device will deliver a small electric charge through 5 needles to increase the amount of the study vaccine taken up by the muscle.
15809933|NCT04367662|Procedure|blood sampling|blood sampling in hospitalized patient for COVID-19 infection
15809934|NCT04367649|Other|Hall technique|"Orthodontic separators will be used to create space for fitting the stainless crown, then removed after 3-5 days
~Occlusion will be measured assessing the patient's occlusal-vertical dimensions (OVD) using a modified version of van der Zee and van Amerongen method with a millimeter probe measuring the distance from the lowest point of the gingiva, around the lower canine on the vestibular side up to the point where the tip of the upper canine ends in order to assess the degree of overbite after mounting of the crown.
~The correct crown size will be selected. The crown should cover all the cusps and approaches the contact points, with a slight feeling of spring back. till reaching the gingival margin. Cementation will be done using glass ionomer cement"
15809935|NCT04367649|Other|Atraumatic restorative treatment|Caries removal using excavators, then restoration using glass ionomer (GIC)
15809936|NCT04367649|Other|Conventional restorative treatment|Complete caries removal using high-speed hand piece, and an excavator to clear carious dentin from the pulpal wall. Then, stainless steel crown preparation, selection of the proper size with the smallest crown size that completely covers the preparation chosen. The correct occlusogingival crown length will be established. Cementation will be done using glass ionomer cement
15809937|NCT04367636|Behavioral|Behavioral: OCAT-sham|Placebo version of the online contingent attention training preceded by psycho-education movieclip.
15809938|NCT04367636|Behavioral|Behavioral: OCAT|Online contingent attention training preceded by psycho-education movieclip.
15809939|NCT04367636|Other|psycho-education video|Both groups get to see a psycho-education video before the smartphone training starts.
15809940|NCT04367623|Other|Brain computer interface based therapy|Participants who decide to take part will be assigned to a treatment or a control group. Both groups will have the same assessments and the same number of therapy sessions. Therapy group will have a training that consists of Brain Computer Interface controlled Functional Electrical Stimulation followed by a physical practice of the dominant upper limb, while the control group will have a physical practice only. One experimental session will last about 60 min for both groups (including setup and therapy) and participants in each group will receive 20 sessions, about 3 times per week. The expected time needed for completion of 20 sessions is 7 weeks
15809941|NCT04367597|Device|Home-based Neuromuscular Electrical Stimulation (NMES) therapy|A home-based NMES treatment applied by the subjects daily
15809943|NCT04367571|Other|Osteopathic Manipulative treatment (OMT)|"OMT techniques were focused on correcting the dysfunctions found before each OMT session and included myofascial techniques, balanced ligamentous tension, visceral manipulations and osteopathy in the cranial field.
~OMT group will receive a total of 4 sessions, one time each week for 4 weeks. Each session will last 40 minutes. It will be required by the patients to modify their bowels habits. The subjects will be evaluated right at baseline (T0), after one month (T1) after four sessions (T2) and after 1 month after the treatment (T3)."
15809944|NCT04367571|Other|Manual Placebo (MP)|"The MP treatment consists of passive touch without joint mobilization in a protocolled order. The practictioners will be standing next to the bed, they'll touch lumbar and dorsal spine of the subjects in prone position for 10 minutes, and then in supine position, they'll touch for 10 minutes the shoulders, the hips, then the neck, the sternum and the chest for 5 minutes each.
~MP group will receive a total of 4 sessions, one time each week for 4 weeks. Each session will last 40 minutes. It will be required by the patients to modify their bowels habits. The subjects will be evaluated right at baseline (T0), after one month (T1) after four sessions (T2) and after 1 month after the treatment (T3)."
15809945|NCT04367558|Procedure|Minimally invasive, in-office, RF reduction of the affected area|Usage of RF needle to treat one or more of the affected areas
15809946|NCT04367545|Diagnostic Test|Saliva collection|Saliva collection will be done in addition to standard diagnosis collection (nasopharyngeal collection using swab)
15809947|NCT04367532|Other|Foam rolling|Foam rolling performed on cuff muscles in 3 sets of 30 seconds per each muscle part in duration with a 15-second rest between sets. The first sets on the central part of the cuff muscles, the second on the medial and third on the lateral side of the cuff.
15809948|NCT04367532|Other|Tissue flossing|A standard cuff muscle bandaging technique on cuff muscle. After the application, each participant is asked to perform a 2 min ankle-exercise program.
15809949|NCT04367519|Diagnostic Test|Ultrasound measurement of Optic nerve sheath diameter|Ocular ultrasonography was performed with the patients placed in supine position with closed eyes. A layer of ultrasound gel was applied over the closed upper eyelid and the liner high frequency probe 7 - 12 MHz of SonoSite M-Turbo ultrasound machine was placed on the temporal area of the eyelid with the hand holding it resting on the forehead of the patient. The probe is then adjusted to a suitable angle in order to display the entry of the optic nerve into the globe. ONSD is then measured 3mm behind the globe in the transverse plane perpendicular to the optic nerve. For each eye one measurement will be made and the reported ONSD corresponds to the mean of the two values obtained for each patient. it was performed for all enrolled parturients within 24 hour before delivery and at 24 hour post-delivery.
15809950|NCT04367506|Behavioral|BecomeAnEX|This research study is focused on a smoking cessation program called BecomeAnEx. We are studying how to adapt BecomeAnEx for people with a mental health disorder who want to reduce or quit their tobacco smoking. BecomeAnEx includes a website that provides education about smoking and quitting. It also has a text messaging program that delivers personalized information. Persons in the program have access to real-time digital coaching with a remote coach who has experience helping people quit smoking. In addition, the program has an on-line community of current and former smokers that can provide support and encouragement.
15809951|NCT04367506|Behavioral|Usual Care|Usual care represents what hospitalized psychiatric patients normally receive in terms of smoking cessation: brief individual counseling, NRT during the hospital stay and a prescription for NRT at discharge (consistent with standard hospital procedures), and referral to the MD quitline.
15809952|NCT04367493|Dietary Supplement|Chocolate|25 g of chocolate by day for 4 weeks
15809953|NCT04367480|Device|Placebo Administration|Wear placebo TENS device
15809954|NCT04367480|Other|Questionnaire Administration|Ancillary studies
15809955|NCT04367480|Device|Transcutaneous Electrical Nerve Stimulation|Wear active TENS device
15809956|NCT04367467|Other|Kidney Function Test|Cystatin-C measurement
15809957|NCT04367454|Other|Use of Personal Protective Equipment|As described in the arm descriptions
15809958|NCT04367441|Drug|608|recombinant humanized anti-IL17A monoclonal antibody injection
15809959|NCT04367441|Drug|Placebo|auxiliary material of 608 include histidine, histidine hydrochloride, sucrose and polysorbate 80
15809960|NCT04367428|Biological|Administration of probiotics|Patients will receive the previously mentioned combination of probiotics before and after surgery
15809961|NCT04367415|Diagnostic Test|Darwish test for a free endometrial cavity|Darwish test (Office hysteroscopic bubble suction and tubal peristalsis). If the uterine cavity is normal the patient will be allocated as group A
15809962|NCT04367415|Diagnostic Test|Darwish test for an endometrial cavity with endometrial polyps|Darwish test (Office hysteroscopic bubble suction and tubal peristalsis).If there is one or more polyp(s) the patient will be allocated as group B.
15809963|NCT04367402|Other|BioMedomics COVID-19 IgM-IgG Rapid Test|Qualitative test to aid in the diagnosis of COVID-19 novel coronavirus
15809964|NCT04367389|Behavioral|Physical activity promotion|Physical activity promotion activities consist of two phone or video calls with a therapists, two group video calls with a therapist, a complementary e-learning course and a fitness tracker that was provided.
15809965|NCT04367389|Behavioral|Exercise|Participants will agree with their therapist on an exercise plan (endurance and resistance training) that will be made available through the studies mobile app. Frequency and duration of endurance and strength training shall be prescribed in accordance with exercise guidelines for persons with MS. However, they can be adjusted according to participants prior physical activity level and their time for exercise during the week.
15809966|NCT04367376|Other|mobilization|central postroanterion mobilization on the most painful vertebral level at the lumbar spine
15809967|NCT04367376|Other|manual therapy|manual therapy
15809968|NCT04367376|Other|instrumental manual therapy|instrumental manual therapy
15809969|NCT04367363|Behavioral|Social media & news consumption|Daily reports of social media use and consumption, including reports on receiving and disseminating news articles related to the COVID-19 situation (e.g., how many messaging groups shared news on the outbreak, how many items related to the outbreak they forwarded to others, etc).
15809970|NCT04367350|Diagnostic Test|laboratory biomarkers|creatine kinase, troponin, urine myoglobin, and autoimmune antibodies
15809971|NCT04367350|Diagnostic Test|muscle ultrasound|Muscle echogenicity in the upper and lower extremities, the accessory respiratory serratus anterior muscle, and abdominal wall according to qualitative ultrasound assessment (Heckmatt score)
15809979|NCT04367285|Other|Sensor-based Training|Sensor-based Training consists of twelve sessions of upper limb training with PABLO®-Tyromotion. For each session the training consists in interactive-games based on virtual reality which allowed a task-oriented approach and a neurocognitive feedback. The exercises require precision tasks and one-dimensional and bidimensional reaction, allowing to train the attention, the strength control and movement control, the coordination and the movement precision. The interactive-games were chosen from those proposed by the Tyromotion PABLO® System.
15809980|NCT04367285|Other|Upper limb motor training|Upper limb motor training, without robotic support. Subjects performed specific exercises aimed to recovery global upper limb functions, to control hand grasp and to improve hand's fine movements.
15809981|NCT04367272|Procedure|First Arthroplasty|First Knee
15809982|NCT04367272|Procedure|Second Arthroplasty|Second Knee
15809983|NCT04367259|Procedure|TMJ Arthrocentesis|Temporomandibular joint arthrocentesis
15809984|NCT04367246|Other|No Intervention|No intervention is assigned.
15809985|NCT04367233|Other|General anesthesia|General anesthesia with fentanyl, propofol and remifentanil.
15809986|NCT04367233|Other|Transverse abdominal block|Transverse abdominal block with levobupivacaine 0,25% 0,2 ml/kg at the end of general anesthesia with fentanyl, propofol and remifentanil
15809987|NCT04367233|Other|Quadratus lumborum block|At the end of general anesthesia with fentanyl, propofol and remifentanil, patients will receive quadratus lumborum block with levobupivacaine 0,25% 0,2 ml/kg
15809988|NCT04367220|Diagnostic Test|Diagnostic testing performed as per routine care|
15809989|NCT04367194|Behavioral|Neurorehabilitation|After examination of the patients, the patients undergo neurorehabilitation. We use virtual reality therapy. Patients perform a submaximal load that is monitored by a polar clock. We develop endurance, coordination, sensory integration, visual and acoustic input, vestibular training, proprioception training.
15809990|NCT04367181|Device|Diffuse Correlation Spectroscopy (DCS)|Diffuse correlation spectroscopy uses light in the near infrared spectral region to quantify non-invasively cerebral blood flow. The DCS device will be use to monitor blood flow changes over time in all ELGA enrolled babies
15809991|NCT04367181|Device|Amplitude Integrated Electroencephalography (aEEG)|Amplitude Integrated Electroencephalography like EEG it is used clinically to monitor brain function in intensive care settings over longer periods of time. aEEG data will be correlated with CBF variation over time
15809992|NCT04367168|Drug|Colchicine|Colchicine 1mg, 1 ½ pill in day 1 and ½ pill BID during 10 days in both mild and severe COVID-19
15809993|NCT04367168|Drug|Placebo oral tablet|Placebo, 1 ½ pill in day 1 and ½ pill BID during 10 days in both mild and severe COVID-19
15809994|NCT04367155|Drug|Tranexamic acid injection|hemostatics use
15809995|NCT04367142|Diagnostic Test|COVID-19 RT-PCR|Nasopharyngeal swabs for COVID-19 RT-PCR
15809996|NCT04367142|Diagnostic Test|Biosensor|Portable and Connected Biosensor viral
15809997|NCT04367129|Diagnostic Test|ECG|12 lead electrocardiogram
15809998|NCT04367116|Procedure|Spinal Cord Stimulation|Spinal cord stimulation is a treatment that implants a electrode in posterior epidural space of patient's spinal canal to send mild electric current to stimulate conducting bundle of the posterior column of the spinal cord and posterior horn sensory neurons.
15809999|NCT04367103|Drug|Norepinephrine|prophylaxis for hypotension
15810000|NCT04367103|Drug|Phenylephrine|standerd prophylaxis for hypotension
15810001|NCT04367090|Drug|Docetaxel, trastuzumab|Docetaxel and trastuzumab once per cycle
15810002|NCT04367090|Drug|Pyrotinib|Pyrotinib 400 mg orally daily
15810003|NCT04367090|Drug|Pyrotinib, docetaxel and trastuzumab|Pyrotinib 400 mg orally daily plus docetaxel and trastuzumab
15810004|NCT04367077|Biological|MultiStem|intravenous infusion
15810005|NCT04367077|Biological|Placebo|intravenous infusion
15810006|NCT04367051|Drug|Withdrawal of Spironolactone|Other recommended medications for heart failure than spironolactone will be continued for withdrawal group.
15810007|NCT04367051|Drug|Continuation of spironolactone|Specific dose of spironolactone for continuation group is on each physician's discretion with acceptable range of 12.5 mg - 50 mg once or twice daily.
15810008|NCT04367038|Other|Warm Acupressure, Cold Acupressure , Conventional Acupressure|Acupressure is non-invasive, safe and effective.
15810009|NCT04367025|Drug|Camrelizumab|Camrelizumab: 200mg,iv drip for 1h,d1,q3w
15810010|NCT04367025|Drug|Oxaliplatin|Oxaliplatin: 130mg/m2, iv drip for 2h, d1, q3w;
15810011|NCT04367025|Drug|S1|S-1:40~60mg Bid, d1~14, q3w;
15810012|NCT04367012|Other|Abdominal Ultrasound|patient in supine position and external carotid artery was examined to meausre the intima using US .Machine GE logic FB inear probe10Mhz.and intimal media thickness mean =10mm
15810013|NCT04366999|Procedure|LSG|The operation was started by replacing the 12-mm bladed trocar, and two additional trocars were inserted. LigaSure was used to dissect the omental pieces of the great curvature and any adhesions of the pancreas and stomach. A 36-French orogastric tube was then placed in the stomach. Gastric transection was started at a distance of approximately 4cm from the pylorus using a stapler (EndoGIA™; Covidien). All stapling was performed with yellow/green/black/blue cartridges. The staple line was reinforced with continuous barbed prolene sutures, and any sites of bleeding were closed with the LigaSure device. The portion of the stomach that had been transected from the pylorus was extracted through the 12-mm trocar site.
15810014|NCT04366999|Procedure|LRYGB|LRYGB is performed as described as standard. In brief, smaller stomach pouch of 10 to 20 ml or larger stomach pouch of 25 to 35 ml were created according to the metabolic status of the patients. The jejunum at approximately 150 cm distal site was dragged up and connected (anastomosed) to the remnant stomach.
15810015|NCT04366999|Procedure|OAGB-MGB|"Four ports are placed generally. Thepaddleretractor is used to retract the liver. The GIA stapler divides the stomach at the junction of the body and antrum, at a location where the jejunal loop can be brought up comfortably. With 4-6 lines of staples that seal the gastric pouch. The division of the stomach is parallel to the lesser curvature and up to the angle of His. A point is selected on the small bowel about 150 cm distal to the ligament of Treitz. The jejunal loop is brought up antecolic, and the Endo-GIA stapler is used to anastomose the stomach and the small bowel at this point. The distal end of the gastric tube is anastomosed to the side of the small bowel. The inside of the anastomosis is inspected for bleeding before final closure. The stapler then closes the anatomosis."
15810016|NCT04366986|Other|Tested for SARS-CoV-2 (regardless of the result)|This is an observational study with no intervention
15810017|NCT04366986|Other|Clinical diagnosis of COVID-19 by a health care professional|This is an observational study with no intervention
15810018|NCT04366960|Drug|Enoxaparin|Subcutaneous enoxaparin
15810019|NCT04366947|Device|NIO® (Intraosseous access)|obtaining intravascular access using a ready intravenous NIO needle set
15810020|NCT04366947|Device|Standard of Care (Intravenous access)|obtaining intravascular access using a standard intravenous cannula
15810021|NCT04366934|Other|Nasal swab|Nasal swab
15810022|NCT04366934|Other|Taste and olfactory function evaluation|Taste and olfactory function evaluation
15810023|NCT04366908|Drug|BAT + Calcifediol|"The subject will be treated with the best available therapy, which will include any combination of drugs included in the current protocol of the Ministry of Health and/or complementary notes issued by the Spanish Agency of Medicines and Health Products (AEMPS) plus Calcifediol caps. 266 µg. According to the pharmacokinetics of Calcifediol evaluated in an inflammatory model, the posology will be
~Start: 2 capsules Days 3, 7, 14, 21, 28: 1 capsule"
15810024|NCT04366908|Drug|BAT|The subject will be treated with the best available therapy, which will include any combination of drugs included in the current protocol of the Ministry of Health and/or complementary notes issued by the Spanish Agency of Medicines and Health Products (AEMPS).
15810025|NCT04366895|Other|conventional single implant overdenture|conventional manufactured implant overdenture
15810026|NCT04366895|Other|3d printed single implant overdenture|CAD-CAM manufactured implant overdenture.
15810027|NCT04366882|Procedure|CT-scan with minimal invasive autopsy|CT-guided biopsies will be performed directly following the diagnostic CT-scan. Biopsies will be taken from heart, liver, lungs, spleen, kidneys and abdominal fat according to a standard operation procedure. Biopsies will be taken for further histological examination and storage in the biobank. Of the lung, additional samples will be taken for microbiological examination. Additional samples will be taken in case of (focal) abnormalities on CT-imaging. In case of pleural, cardiac or abdominal fluid, this will be aspirated for further cytological, biochemical and microbiological examination. Finally, 15 cc blood will be drawn from the heart.
15810028|NCT04366869|Device|overdenture|removal of overdenture at night
15810029|NCT04366869|Device|occlusal splint|occlusal splint on overdenture
15810030|NCT04366869|Drug|Botox|Botox injection i masseter in temporalis
15810031|NCT04366856|Behavioral|1: Prone positioning|the interventional group will be suggested to spend at least 6 hours a day in prone position
15810032|NCT04366856|Behavioral|2: No instruction regarding positioning|group with no instruction regarding positioning (control group)
15810033|NCT04366843|Other|chair massage|Chair massage was performed useing only traditional methods of Swedish massage were used, consisting of stroking (smooth, continuous movements to relax and calm the sympathetic nervous system), kneading (consisting of wringing, squeezing muscles, compressing pressure points for the relaxation of soft tissues, i.e. muscles, tendons, fascia), stretching combined with swaying and passive movements of the upper limbs (to mobilize the joints of the upper limbs) and final stroking combined with slapping and shaking percussion, vibration.
15810034|NCT04366843|Other|the exercise program|The original set of exercises was developed based on the knowledge and clinical experience of the authors of the study and based on EBP (Evidence Based Practice). The program consisted of 14 strengthening and stretching exercises involving the muscles of the trunk and limbs whose main goal was to mobilize the joints and strengthen the weakened muscles and relax overloaded muscle groups.
15810035|NCT04366830|Drug|Remestemcel-L|Participants will receive remestemcel-L in two infusions of 2 x 10^6 mesenchymal stromal cells per kilogram (MSC/kg), administered intravenously (IV).
15810036|NCT04366817|Behavioral|psychological assessment|psychological assessment at D10-12 and 6-8 weeks : Scheduled telephone interview using the assessment scales (EPDS, PPQ, MIBS, DAS-16) on D10-D12 and 6-8 weeks postpartum with a psychologist
15810038|NCT04366778|Diagnostic Test|TEM-tPA|325 patients with Covid-19 hospitalized in Lyon University Hospitals will have TEM-tPA measurements in parallel to D-dimers every 3 days during the hospitalization period. TEM-tPA of patients with and without thrombosis will be compared and their fibrinolysis (PAI-1, TAFI, tPA, thrombin) will be further explored.
15810039|NCT04366752|Other|venous ultrasound|Venous ultrasound will be performed on patients once a week, every week from the day of admission in ICU until the day of patient discharge
15810040|NCT04366752|Other|blood sample|blood sample for coagulation and hemostasis analysis will be withdrawn from artery catheter from the day of admission in ICU until the day of patient discharge
15810041|NCT04366739|Drug|CHLORPROMAZINE (CPZ)|"Drug List 1, AMM obtained in 1952, AMM 3400930571187 1952/90, RCP revised 22/08/2019 Administration: oral route, if the clinical condition requires it, intravenous administration.
~Initial dosage: 75 mg per day orally (or 37.5 mg per day orally in subjects 75 years of age or older).
~Then: titration up to the maximum tolerated dose, with a minimum of 12.5 mg and a maximum of 300 mg per day by the oral administration (or 600 mg per day by the oral in certain exceptional cases which also correspond to the CPM CPM marketing authorization indications); or from 6.25 to 150 mg per day intravenously.
~Duration of treatment: until healing criteria are obtained (≥ 8 days from the onset of COVID-19 symptoms AND ≥ 48 hours of apyrexia and absence of dyspnea) or 21 days maximum"
15810042|NCT04366739|Combination Product|Standard of Care (SOC)|"In the absence of a reference treatment in COVID-19, the standard of care (SOC) is the comparison arm"
15810043|NCT04366726|Combination Product|abaloparatide-sMTS|abaloparatide 300 μg applied to the thigh for 5 minutes once daily for 29 days
15810047|NCT04366700|Procedure|Periapical surgery with autograft and collagen membrane|periapical surgery will be done and the defects will be filled with a mixture of autograft and prf and will be covered with a collagen membrane
15810048|NCT04366700|Procedure|Periapical surgery with collagen membrane|periapical surgery will be done and the defects will be filled with blood clot and covered with a collagen membrane
15810049|NCT04366687|Behavioral|Smart Parents - Safe and Healthy Kids|Smart Parents - Safe and Healthy Kids (SPHSK) is a module designed to be added to existing evidence-based parent education programs. Because the module builds off of the core parenting skills developed in existing parent education programs, the module can be delivered in one session. SPSHK is comprised of three key CSA-prevention components: healthy child sexual development, parent-child communication about sex and sexual behaviors, and CSA-specific safety strategies such as vetting a babysitter and monitoring one-on-one time with adults. Behaviorally based, the module presents developmentally comprehensive information to parents of children 0-13 and utilizes role-playing scenarios and activities to maximize parents' use of learned skills.
15810050|NCT04366687|Behavioral|Parents as Teachers|Parents as Teachers (PAT) is a parent-support program delivered to parents of children under five and focuses on improving parenting skills through parent-child interactions, development centered parenting, and general well-being. PAT has demonstrated positive effects on child and parent outcomes related to school readiness.
15810051|NCT04366674|Procedure|cleft palate repair|restoration of tensor veli palatini for the purpose of the muscle function recovery.
15810052|NCT04366661|Diagnostic Test|low dose CT|Invited participants from institutes exposed to a high level of smoke pollution such as employees of Transport and Oil Ministries are inquired for their personal history of cigarette smoking then subjected to low dose CT
15810053|NCT04366648|Drug|JK-1201I|malignant solid tumor that has been confirmed by histopathology and/or cytology
15810054|NCT04366635|Procedure|Impacted third molar surgery|Under local anesthesia, flap will be raised and mesioangular or horizontal impacted third molar tooth will be removed with routine technique. And then extraction socket will be irrigated with salin and will be primarily closed.
15810055|NCT04366635|Procedure|Application of mineralised plasmatic matrix|After extraction of impacted third molar tooth, Mineralized Plasmatic Matrix will be placed to the socket as a graft material and will be covered with Platelet Rich Fibrin membrane. Then wound will be primarily closed.
15810056|NCT04366635|Procedure|Application of β-tricalcium phosphate|After extraction of impacted third molar tooth, β-tricalcium phosphate will be placed to the socket as a graft material and will be covered with Platelet Rich Fibrin membrane. Then wound will be primarily closed.
15810057|NCT04366622|Drug|Riociguat (Adempas, BAY 63-2521)|0.5 mg riociguat as an immediate-release (IR) tablet
15810058|NCT04366609|Drug|Methylphenidate|Treatment with methylphenidate through dose escalation
15810059|NCT04366596|Device|Angioplasty with paclitaxel eluting balloon|The patients will be treated with renal artery angioplasty using paclitaxel eluting balloon
15810060|NCT04366596|Device|Angioplasty with plain old balloon|Angioplasty with plain old balloon
15810061|NCT04366583|Device|argon plasma coagulation|Olympus electrosurgical unit/argon plasma coagulation unit (PSD-60/Endoplasma, Olympus Corp., Tokyo, Japan)
15810062|NCT04366583|Device|hemoclipping|clipping device (Olympus HX 110/610, Olympus Corp., Tokyo, Japan)
15810063|NCT04366570|Other|clinical assessment of the shoulder and the cervical spine includes stress guideline tests|As a result of statistical processing, we are planning to obtain the most sensitive and specific tests from the clinical examination protocol
15810064|NCT04366557|Other|Manual therapy, exercises and education program|a six week body posture therapy consisted of manual therapy (once per week) and home exercises; education about pelvic floor
15810065|NCT04366557|Other|Education program|education about pelvic floor
15810066|NCT04366544|Other|Part A1: Survey|Online
15810067|NCT04366544|Other|Part A2: Sample collection|Blood and Stool
15810068|NCT04366544|Other|Part B:|EEG and fMRI
15810069|NCT04366531|Behavioral|START-VET|prison reentry program
15810070|NCT04366531|Other|Treatment as usual|This intervention involves no additional services above what is provided by the local health care system
15810071|NCT04366518|Drug|Physostigmine Salicylate|Consistent with safety and efficacy demonstrated in prior studies, the authors propose to dose physostigmine IV at a rate of 1.5mg/hr during the two-hour treatment period, verified by blood levels. This dose is less than that typically used for treatment, and glycopyrrolate, a cholinergic antagonist that does not cross the blood-brain barrier, will be administered prior to physostigmine to block peripheral side-effects.
15810072|NCT04366518|Drug|Scopolamine|The authors have chosen to use scopolamine to determine the effects of cholinergic antagonism, as treatment with scopolamine demonstrates a dose-related increase in propensity toward conditioned hallucinations and in doses much higher than those proposed here, can cause spontaneous hallucinations. At the proposed dose, scopolamine has an excellent safety profile and has been used routinely for nearly 20 years for treatment of nausea due to surgery or motion sickness in adults and children. Scopolamine is available in the US only as a 1mg / 72 hours transdermal patch, and peak plasma levels are reached within 24 hours. This standard doseage level is very well tolerated in the general population.
15810073|NCT04366518|Drug|Saline|Participants in Aim 2 will receive a saline drip as a placebo versus Physostigmine.
15810074|NCT04366518|Drug|Placebo|Participants in Aim 1 will receive a placebo patch versus scopolamine patch.
15810075|NCT04366505|Behavioral|Treatment as usual (TAU) and neurofeedback (NFB)|This group will receive Treatment as usual (TAU) and neurofeedback (NFB). During NFB, participants will be asked to regulate the signal from a target brain region during the presentation of alcohol cues. The ventral striatum was chosen as target region.
15810076|NCT04366505|Behavioral|mindfulness-based relapse prevention (MBRP) and NFB|This group will receive MBRP and neurofeedback (NFB). MBRP consists of 5 extensive sessions of a specific manualized mindfulness-based intervention for alcohol dependent patients which will be carried out by trained psychologists and psychotherapists. During NFB, participants will be asked to regulate the signal from a target brain region during the presentation of alcohol cues. The ventral striatum was chosen as a target region.
15810077|NCT04366505|Behavioral|TAU and sham NFB|This group will receive TAU and sham NFB. Sham NFB means that the signal displayed to the participant is based on activity in a control region, the auditory cortex, which is not involved in cue reactivity.
15810078|NCT04366505|Behavioral|MBT and sham NFB|This group will receive MBRP and sham NFB. MBRP consists of 5 extensive sessions of a specific manualized mindfulness-based intervention for alcohol dependent patients which will be carried out by trained psychologists and psychotherapists. Sham NFB means that the signal displayed to the participant is based on activity in a control region, the auditory cortex, which is not involved in cue reactivity.
15810079|NCT04366492|Other|Prevalence of blood borne viral infections (HBV/HCV/HIV)|rapid finger prick test for HCV Ab, HBsAg and HIV and a questionnaire
15810080|NCT04366479|Behavioral|Multistage Fitness Test|Participants only joined in one group will be given intervention for 5 weeks in the form of running 1600 meters duration of 20-30 minutes 3 times a week. It is important for the participants as well as for us to know which training methods are given. this information will be documented in our file, but we will not see these files until after the research is complete. this is the best way we have for testing without being influenced by what we think or expect might happen.
15810081|NCT04366466|Other|suicide attempt patient using PEPS Program|"The research protocol consists of two phases separated by randomization.
~A Hospital Phase common to both groups:
~Day zero is the day of the suicide attempt for which the patient came to the hospital.
~A post-hospital phase including the P.E.P.S. program for the intervention group and telephone reminders for the usual treatment group."
15810082|NCT04366453|Procedure|echocardiography|Four measurements in echocardiography performed in addition to standard care
15810083|NCT04366440|Behavioral|Order set review and modification with facilitation|The antimicrobial stewardship program will receive facilitation training to aid in reviewing and changing order sets of clean or clean-contaminated procedures to eliminate unnecessary post-operative antibiotics.
15810084|NCT04366440|Other|Order set review and modification|The antimicrobial stewardship program will work to eliminate unnecessary post-operative antibiotics by reviewing and changing order sets of clean or clean-contaminated procedures.
15810085|NCT04366427|Combination Product|L-HBO|as previously described.
15810086|NCT04366427|Combination Product|HBO|as previously described.
15810087|NCT04366427|Combination Product|30% O2|as previously described
15810088|NCT04366427|Combination Product|50% O2|as previously described
15810089|NCT04366414|Other|hook breathing removing nose-clip|"Participants will perform 3 days per week of usual training, involving intense exercise 8 submaximes-dynamic apnoeas with 3-minute recovery between each one per session, and continuous training of free style swimming at moderate effort over 30 minutes, including warm-up, recovery between intervals and cool down.
~The experimental breathing protocol consisted on to remove nose-clip previous to surface and then perform hook breathing during 20 seconds."
15810090|NCT04366414|Other|usual breathing (UB)|Participants will perform 3 days per week of usual training, involving intense exercise 8 submaximes-dynamic apnoeas with 3-minute recovery between each one per session, and continuous training of free style swimming at moderate effort over 30 minutes, including warm-up, recovery between intervals and cool down.
15810091|NCT04366401|Behavioral|Conventional Dietary Advice|"The education content in the control group will be centered on the acquisition of knowledge about:
~- Underlying mental pathology, lifestyles and associated comorbidities
~- Immediate principles: Carbohydrates, lipids, proteins, fiber, vitamins, and minerals; energy needs; consumption requirements.
~- Water requirements.
~- Foodstuffs.
~- Culinary techniques: conservation of properties of the diet.
~- Feeding in particular situations."
15810092|NCT04366401|Behavioral|Prebiotic/Probiotic Dietary Modulation|"The education content in the intervention group will be based on general principles of conventional dietary advice in an intensified manner, centered on the acquisition of specific knowledge about:
~- Underlying mental pathology, lifestyles and associated comorbidities
~- Immediate principles: Carbohydrates, lipids, proteins, fiber, vitamins, and minerals; energy needs; consumption requirements.
~- Water requirements.
~- Foodstuffs.
~- Description and justification of prescribed prebiotic and probiotic diet.
~- Culinary techniques: conservation of properties of the prebiotic and probiotic diet.
~- Optimal distribution and interchange of foods with high prebiotic and probiotic content.
~- Feeding in particular situations."
15810093|NCT04366388|Device|ActivPAL3 VT (PAL Technologies Ltd).|. The ActivPAL will be fitted by a trained research assistant on the mid-thigh of the participants' dominant leg. ActivPALs have an inclinometer that detects the joint angle of the thigh to capture lying, sitting, standing, and stepping activities.
15810094|NCT04366375|Diagnostic Test|PTX-3|Pentraxin-3 ng/mL PTX-3 levels were measured using human PTX3 ELISA Kit 96 Tests/Box (Cat. No: CK-E90303) (Hangzhou Eastbiopharm Co.,Ltd., PRC) read by a ELISA device matching with the kit. For the purpose of measurement, microplate washer RT 2600 device and Rayto microplate reader RT 2100C device were used.
15810095|NCT04366362|Procedure|Individualised ACL reconstruction|ACL reconstruction based on anatomical and functional distinctiveness of each patient separately
15810096|NCT04366362|Procedure|Conventional ACL reconstruction|ACL reconstruction based on surgeons experience without taking into account any other patients characteristics
15810097|NCT04366349|Biological|GSK3772847 70 milligram (mg)|GSK3772837 will be available at a dose strength of 70 milligram per milliliter (mg/mL) in a 3 milliliter (mL) glass vial.
15810098|NCT04366349|Biological|GSK3772847 140 milligram (mg)|Two doses of GSK3772837 70 milligram per milliliter (mg/mL) will be administered to achieve a dose strength of 140 milligram per milliliter (mg/mL)
15810099|NCT04366349|Other|Placebo|Placebo to match GSK3772847 will be available in the form of solution for injection in a 3 milliliter (mL) glass vial.
15810100|NCT04366336|Procedure|Blood Flow Restriction Training|Same as Standard PT with the exception that BFRT involves placing the pressure cuff before the start of therapeutic exercises
15810101|NCT04366336|Procedure|Standard Physical Therapy|Therapeutic exercise, including but not limited to: movement re-education, balance, and functional strength training; and Manual Physical Therapy including but not limited to passive range of motion (therapist will move your knee without your help), joint mobilization, soft-tissue mobilization and static stretching
15810102|NCT04366323|Drug|ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS|Two doses of 80 million adipose-tissue derived mesenchymal stem cells
15810103|NCT04366310|Device|capillary refill index|a waveform analysis method using a pulse oximeter to assess peripheral perfusion
15810104|NCT04366310|Procedure|rewarming|warming fingertip skin temperature using an instant hot pack
15810105|NCT04366297|Device|Intravenous access|obtaining intravascular access using a standard intravenous cannula
15810106|NCT04366297|Device|Intraosseous access|obtaining intravascular access using a ready intravenous NIO needle set
15810107|NCT04366284|Other|No Facilitation Support|Clinicians will have full use of the NOCTEM platform. They will not have scheduled and/or structured contacts with the facilitation teams, however can reach out to the NOCTEM team or their local point of contact and coordinator with questions or technical issues that may arise.
15810108|NCT04366284|Other|External Facilitation Support|Clinicians will have full use of the NOCTEM platform and the NOCTEM team will provide external facilitation via bi-weekly consult or supervision teleconference, or via telephone. The NOCTEM team will also be available by email and text messaging on an as needed basis.
15810109|NCT04366284|Other|External and Internal Facilitation Support|Clinicians will have full use of the NOCTEM platform and external facilitation support. In addition to external facilitation by the NOCTEM team a local point of contact and coordinator will serve as a more proximal facilitator.
15810110|NCT04366271|Biological|Mesenchymal cells|1 infusion of undifferentiated allogeneic mesenchymal cells derived from umbilical cord tissue
15810111|NCT04366271|Drug|Standard of care|Best treatment option for COVID-19 according to investigator criteria
15810112|NCT04366258|Device|Transcranial photobiomodulator|The tPBM-2.0 is an investigational device based on LiteCure's LightForce® EXPi Deep Tissue Laser TherapyTM System. For the investigational study, the EXPi System's beam delivery - EmpowerTM, is modified to non-invasively deliver Near-Infrared Radiation (NIR) to subjects diagnosed with MDD. The modified system is also configured to provide sham (placebo) treatment. The device is manufactured and supplied by LiteCure LLC, 101 Lukens Dr, Suite A, New Castle, DE 18720. The tPBM-2.0 is considered a Class II medical device per 21 CFR 890.5500 and 878.4810 and is manufactured per 21 CFR 820. It utilizes a laser diode source with a maximum continuous (CW) output of ≤30 Watts at a wavelength of 808 nanometers (nm) and nominal beam diameter of 40mm at the outside aperture. Transcranial photobiomodulator (t-PBM) deliver 3 different doses of irradiance: HIgh (770 mW/cm2), Middle (300 mW/cm2) and Low (50 mW/cm2).
15810113|NCT04366258|Device|Sham|Transcranial photobiomodulator (t-PBM) will delivering irradiance dose of 0 mW/cm2.
15810114|NCT04366245|Biological|Hyperimmune plasma|PLASMA OF CONVALESCENT COVID-19
15810115|NCT04366245|Drug|Standard of care for SARS-CoV-2 infection|Standard of care for SARS-CoV-2 infection
15810116|NCT04366232|Drug|Anakinra alone (stages 2b/3)|Anakinra 300 mg 1/d Intravenous 5 days then dose tapering
15810117|NCT04366232|Drug|Anakinra and Ruxolitinib (overcome stage 3)|Anakinra 300 mg od Intravenous (maximum14 days) Ruxolitinib 5 mg bid per os (maximum 28 days)
15810118|NCT04366232|Other|Standard of care|Routine clinical care for Covid-19
15810119|NCT04366193|Diagnostic Test|Oximetry|Validation of a high-resolution wireless oximeter for OSA diagnosis comparing with a well established and validated method (home sleep test).
15810120|NCT04366180|Dietary Supplement|Probiotic|The probiotic group will received one capsule with Lactobacillus K8 per day (3x10^9 cfu/day) during 2 months
15810121|NCT04366180|Dietary Supplement|Control|The control group will received one placebo capsule per day during 2 months
15810122|NCT04366167|Other|Cardiac surgery|Cardiac surgery during the COVID-19 pandemic
15810123|NCT04366154|Other|Questionnaire|delivery of questionnaires on perceived stress, post-traumatic stress, sleep disorders, quality of life, cognitive complaint
15810124|NCT04366141|Device|COVID-19 barrier box|Attending anesthesiologists will use a plastic proprietary barrier enclosure for intubating patients in the intervention group to protect spreading aerosolized droplets from patient to health care provider.
15810125|NCT04366128|Drug|CAPA indution immunotherapy|"Camelirumab 200mg Intravenous injection on day 1.
~Apatinib 250mg taken orally once daily.
~Pegaspargase 2000U/m2 Intramuscular injection on day 1."
15810126|NCT04366115|Drug|AVM0703|Single IV infusion at 10 mg/mL in normal saline over 1 hour to patients.
15810127|NCT04366115|Drug|Placebo|Single IV infusion in normal saline over 1 hour to patients.
15810130|NCT04366089|Other|Oxygen-ozone therapy, probiotic supplementation and Standard of care|- systemic autohemotherapy with Ozone 30 mcg / ml 250ml 2 times / day for 7 days
15810131|NCT04366089|Dietary Supplement|SivoMixx (200 billion)|Composition of SivoMixx: Streptococcus thermophilus DSM322245, Bifidobacterium lactis DSM 32246, Bifidobacterium lactis DSM 32247, Lactobacillus acidophilus DSM 32241, Lactobacillus helveticus DSM 32242, Lactobacillus paracasei DSM 32243, Lactobacillus plantarum DSM 32244, Lactobacillus brevis DSM 27961 (NB: DSM n°... : bacterial strain identification code)
15810132|NCT04366089|Drug|Azithromycin|dose: 500mg 1 cp / day (alternatively lopinavir/ritonavir cps 200/50 mg, 2 cps x 2 / day or darunavir 800 mg 1 cp / day + ritonavir 100 mg 1 cp / day or darunavir/cobicistat 800/150 mg 1 cp / day)
15810133|NCT04366089|Drug|hydroxychloroquine|dose: 200 mg, 1 cp x 2 / day
15810134|NCT04366076|Diagnostic Test|Fetal heart rate (FHR) monitoring through computerized cardiotocography (cCTG) analysis antepartum|The investigator conducted antepartum surveillance through computerized cardiotocography (cCTG) analysis antepartum. This is a non-invasive method to study fetal well being. For each patient, a cCTG was attended using a computerized cardiotocography machine. External cCTG was practised for no less than 20 min (max 60 min), two transducers were fixed on the maternal abdomen: one above the fetal heart level and the other at the uterine fundus
15810135|NCT04366063|Biological|Cell therapy protocol 1|Cell therapy protocol 1(n=20). Patients will receive two doses of MSCs 100×10e6 (±10%) at Day 0 and Day 2 plus Conventional treatment.
15810136|NCT04366063|Biological|Cell therapy protocol 2|Patients will receive two doses of MSCs 100×10e6 (±10%)at Day 0 and Day 2, intravenously plus two doses of EVs at Day 4 and Day 6 plus conventional treatment.
15810137|NCT04366050|Drug|Ramipril 2.5 MG Oral Capsule|Include description or ramipril from protocol
15810138|NCT04366050|Drug|Placebo oral capsule|Placebo
15810139|NCT04366037|Other|Routine training|Training will be defined by each club coach
15810162|NCT04365855|Diagnostic Test|Magnetic Resonance Elastography|Combines MRI imaging with sound waves to create a visual map (elastogram) showing the stiffness of body tissues.
15810163|NCT04365855|Other|Blood draw|Clinical blood tests with a focus on liver function parameters and diabetes
15810164|NCT04365855|Procedure|Liver biopsy|If indicated per MRE results a biopsy will be taken of the liver.
15810401|NCT04364022|Drug|Lopinavir/ritonavir|2x 200mg/50mg, twice daily for 5 days (bid, PO)
15810140|NCT04366037|Other|Routine training + proprioceptive exercise in warm-up|"Training will be defined by each club coach, adding four proprioceptive exercises in warm-up:
~Exercise Description Duration Antero-posterior bipodal horizontal jump Players will jump forward and backward with both feet together, keeping their hands on their waists 30 seconds Unipodal lateral jump Players will perform single-leg lateral jump on both sides of a previously drawn line on the ground, and keeping their hands on their waists. 30 seconds per limb.
~Antero-posterior unipodal horizontal jump Players will jump forward and backward with one foot, keeping their hands on their waists 30 seconds per limb.
~Bipodal vertical jump with or whitout ball. Players will perform vertical jumps with both feet carrying a ball in their hands (this added difficulty will be optional). 30 seconds"
15810141|NCT04366037|Other|Routine training + proprioceptive exercise in cool-down|"Training will be defined by each club coach, adding four proprioceptive exercises in cool-down:
~Exercise Description Duration Antero-posterior bipodal horizontal jump Players will jump forward and backward with both feet together, keeping their hands on their waists 30 seconds Unipodal lateral jump Players will perform single-leg lateral jump on both sides of a previously drawn line on the ground, and keeping their hands on their waists. 30 seconds per limb.
~Antero-posterior unipodal horizontal jump Players will jump forward and backward with one foot, keeping their hands on their waists 30 seconds per limb.
~Bipodal vertical jump with or whitout ball. Players will perform vertical jumps with both feet carrying a ball in their hands (this added difficulty will be optional). 30 seconds"
15810142|NCT04366024|Other|other|clinical diagnosis
15810143|NCT04366011|Behavioral|Cognitive Behavioral Therapy (CBT)|CBT teaches a set of cognitive and somatic coping skills to manage panic and anxiety as patients conduct repeated exposure to feared situations and sensations.
15810144|NCT04366011|Behavioral|Capnometry Assisted Respiratory Training (CART)|CART has four major treatment components: educating patients about the etiology and maintenance of PD according to a hyperventilation centered rationale, directing patients' attention to potentially aberrant respiratory patterns, instructing patients in respiratory control techniques, and instructing patients in home breathing exercises.
15810145|NCT04365998|Device|BUBOLight® Device|1 session of phototherapy with BUBOLight® device during 4 hours.
15810146|NCT04365985|Drug|Naltrexone|Low dose naltrexone, 4.5 mg by mouth, given from date of admission through time participant is stable for discharge for inpatient participants with mild/moderate COVID-19 infection stages. Naltrexone will continue for 1 month post hospital discharge. Patients progressing to requirement for advanced oxygenation will be reassess when sedation and assigned to Ketamine arm. Naltrexone may be reduced to 1.5 mg/day if interfering with sedation and can be held when sedation and symptoms of withdrawal is an issue..
15810147|NCT04365985|Drug|Ketamine|Low dose ketamine hydrochloride given intravenously at a dosage of 0.15 mg/kg body weight for maximum 20 mg every 6 hours, to inpatient participants with advanced oxygenation requirements from either time of admission or time of progression of mild/moderate disease until time participant is stable for discharge, as a rescue treatment. If patient is transferred from the naltrexone or placebo arm, they will continue to receive naltrexone/placebo. Dosage of ketamine may be increased to 0.3 mg/kg body weight, maximum 30 mg every 6 hours, if participant does not respond at the lower dosage. Ketamine can be reduced back to 0.15 mg/kg at the clinical decision of the investigator and when patient has hypertensive emergency, the dose can be held until hypertensive emergency is controlled.
15810148|NCT04365985|Other|Placebo|Oral placebo, given from date of admission through time participant is stable for discharge for inpatient participants in mild/moderate COVID-19 infection stages. Placebo will continue for 1 month post discharge. Participants progressing to requirement for advanced oxygenation will be reassigned to Ketamine arm.
15810149|NCT04365972|Behavioral|Attention Bias Modification (ABM)|A home-delivered version of ABM will be administered in this open trial. ABM will be comprised of 5 sessions with a variation of the dot-probe task in which the target probe always replaces the neutral stimuli to induce diversion of attention away from threat. This condition was found effective in reducing anxiety symptoms.
15810150|NCT04365959|Procedure|Prone position|The objective of the study is to value the ability of the prone position to increase the oxygenation of the patient with SARS-cov-2 pneumonia as a lung recruitment index; the PP also prevents the need for intubation and the consequent risk deriving from the procedure itself and from the predisposition to develop superinfections (VAP).
15810151|NCT04365946|Procedure|Gastroscopy|Upper GI endoscopy and biopsy
15810152|NCT04365933|Drug|EYP001a|Oral tablets
15810153|NCT04365933|Drug|Entecavir|Oral tablets
15810154|NCT04365933|Drug|Pegylated interferon alpha2a|Subcutaneous
15810155|NCT04365920|Combination Product|Recovery Management Checkups (RMC)|"The RMC model was designed to improve treatment linkage, engagement, and long-term treatment retention. The conceptual framework was based on the public health theory of chronic disease management, which utilizes ongoing assessment and monitoring through regular face-to-face checkups and early (re)intervention to facilitate detection of relapse, reduce the time to treatment re-entry, and consequently, improve long-term outcomes. The original RMC model includes: 1) a fixed schedule of face-to-face quarterly checkups to assess need for SUD treatment, 2) personalized feedback based on an assessment and motivational interviewing to increase treatment motivation, 3) problem solving around barriers to treatment access and retention, and 4) assistance with scheduling and linkage to treatment. Individuals were deemed to be in need of treatment if they reported weekly, or more frequent, substance use since the last checkup, any past-month SUD symptoms, or self-perceived need for treatment."
15810156|NCT04365920|Combination Product|RMC-Adaptive|"Participants in the RMC-Adaptive group will receive face-to-face monthly checkups during the first 2 months post-release with additional face-to-face checkups dependent upon the participant's progress. Based on the data presented in the prior section, as long as participants need treatment, they will receive monthly checkups.
~In addition, for every checkup that a participant does NOT need treatment, the number of months before the next checkup will be increased by 1 month (e.g., after 2 checkups without need, they will receive the next checkup 2 months later, after 3 it will be 3 months, after 4 it will be 4 months, and so on). Based on these decision rules, individuals who have NO treatment need over 24 months will still receive 5 checkups."
15810157|NCT04365907|Drug|Zafatek tablets|Once weekly new anti-diabetic drug approved only in Japan
15810158|NCT04365894|Other|Transformative learning theory|According to the transformative learning theory, learning methods in education should include four activities as investigate, collaborative, higher-order thinking and interactive learning activities
15810165|NCT04365855|Procedure|Fibro Scan|If indicated per MRE results a fibroscan will be performed of the liver.
15810166|NCT04365842|Behavioral|Digital exercise group|"Hand Rehabilitation Program: Developed hand exercise smartphone app which include: Self-assessment, (b) self-monitoring (c) exercises types/frequency/ diary, (d) patient education, (e) behavioral change and encouragement (f) exercise adherence Sample exercises
~Hand and finger movements: 6-8 repetitions, according to the diagnosis of the patient
~Strengthening exercises of hand and finger muscles
~Exercises to increase grip and pinch strength
~Exercises to increase tendon swing and pull angle"
15810167|NCT04365842|Other|General Home Hand Therapy|"Hand rehabilitation home program will be given to the through the telephone messages with brochures.
~Hand and finger movements: 6-8 repetitions, according to the diagnosis of the patient
~Strengthening exercises of hand and finger muscles
~Exercises to increase grip and pinch strength
~Exercises to increase tendon swing and pull angle"
15810168|NCT04365829|Device|"virtual reality headset Occulus GO"|"Use of a virtual reality headset for one week at a frequency of 3 days per week (D1, D3 and D5). During each session (1 hour), the subject will visualize a scene of natural virtual environment (a garden, animals in the wild, a grand Canyon) lasting 7 min using an virtual reality headset Occulus GO."
15810169|NCT04365816|Other|Interview|A survey was created, aiming to collect information about prior history of chronic disease, the Self-Evaluation of Food Intake, dysregulations (anosmia, ageusia...), anthropometric data, food data during and after hospitalisation, healthcare consumption since the discharge from hospital
15810171|NCT04365777|Other|OAA/S=5|Prior to anesthesia induciton, EEG signatures will be recorded at Observer's Assessment of Alertness/Sedation (OAA/S) score of 5 (awake, eye-close state) for few minutes.
15810172|NCT04365777|Other|OAA/S=3|Given sedative anesthetics (propofol, midazolam or dexmetomidine), EEG signatures will be recorded after reaching steady state of OAA/S=3 (responds only after name called loudly and/or repeatedly) for few minutes.
15810173|NCT04365777|Other|OAA/S=1|Increasing drug concentration, EEG signatures will be recorded after reaching steady state of OAA/S=1 (does not respond to noxious stimuli) for few minutes.
15810174|NCT04365751|Procedure|Percutaneous microwave ablation, Laparoscopic hepatectomy|For patients with hepatocellular carcinoma who meet the enrollment requirements, under the guidance of ultrasound, microwave ablation electrodes were implanted into the tumor tissues by percutaneous puncture, and the high-temperature heat energy was generated to cause coagulation necrosis of the tumor, so as to achieve the goal of local tumor treatment with minimally invasive technology.
15810175|NCT04365738|Other|Rehabilitation|Chest and diaphragm respiration, in-house mobilization, joint range of motion exercises was performed to the patients as breathing exercises.
15810176|NCT04365725|Drug|Remdesivir|Compassionate provision
15810177|NCT04365712|Device|Piezoelectric tool|
15810178|NCT04365712|Device|Oscillating Saw|
15810179|NCT04365699|Drug|AT-001|Investigational novel Aldose Reductase Inhibitor (ARI) Product: AT-001 500mg capsule for oral administration Dosage: 1,500mg (3X500mg capsules) twice daily Mode of Administration: Oral Up to 14 days per discretion of the investigators and treatment team
15810180|NCT04365686|Drug|Ketofol as induction agent|Patients who received propofol (1mg/kg) plus ketamine (0.5mg/kg) at the induction of general anesthesia
15810181|NCT04365686|Drug|Propofol as induction agent|Patients who received propofol (2mg/kg) only at the induction of general anesthesia.
15810182|NCT04365673|Other|Pharmacist transition of care consultation|Pharmacist-delivered comprehensive medication review
15810183|NCT04365660|Drug|18-F FTC 146|Radiotracer, 10 mCi at pre- and post- chemotherapy, intravenous administration
15810184|NCT04365621|Other|we enrolled ultra-high risk of psychosis (UHR) patient to describe|there is no intervention because we study only the prevalence of patients meeting UHR criteria
15810185|NCT04365608|Procedure|Direct laryngoscopy|standard laryngoscope with Macintosh blade
15810186|NCT04365608|Procedure|Vie Scope laryngoscopy|Vie Scope with dedicated bougie stylet
15810187|NCT04365595|Other|Questionnaires, spirometry|Questionnaires targeting health-related quality-of-life, symptoms, anxiety and depression
15810188|NCT04365582|Drug|Azithromycin|500 mg day 1 ; 250 mg/day for 4 days
15810189|NCT04365582|Drug|Hydroxychloroquine|200 mg x 3/day for 10 days
15810190|NCT04365582|Drug|Lopinavir 200Mg/Ritonavir 50Mg Tab|400/100 mg (2 tablets) x 2/day for 15 days
15810191|NCT04365569|Behavioral|Nutrition and physical activity counseling program|"6-month interventional, counseling program based on nutrition and physical activity consisting of:
~1. Nutritional counseling by a Registered Dietitian (RD) 2) Implementation of an adequate physical activity program"
15810192|NCT04365556|Behavioral|TASC Intervention|All participants receive Step 1 of the intervention. Participants who have adherence below or at 68% will step up to Step 2 or Step 3 after the third or fourth month in the study.
15810193|NCT04365543|Behavioral|Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C/A) for youth with misophonia|Please see arm/group descriptions
15810194|NCT04365543|Behavioral|Psychoeducation and Relaxation Therapy (PRT)|Please see arm/group descriptions
15810195|NCT04365517|Drug|Sitagliptin|We propose a randomized controlled open label intervention study. Patients with type 2 diabetes admitted to COVID-19 and randomized to the study group will be treated with sitagliptin at an adjusted dosage for estimated glomerular filtrate: 100 mg once daily (estimated glomerular filtration rate less than or equal to 45 mL / min / 1.73 m2 ) or 50 mg (estimated glomerular filtration rate 30-45 mL / min / 1.73 m2) in combination or not with insulin. Patients with stage IV and V renal failure (estimated glomerular filtration rate less than or equal to 30 mL / min / 1.73 m2) will be excluded
15810196|NCT04365504|Diagnostic Test|Dual energy X ray absorbtiometry|The primary clinical application of dual-energy x-ray absorptiometry (DXA or DEXA) is the measurement of bone mineral content (BMC, g) and bone mineral density (BMD, g/cm2) of the lumbar spine and proximal femur to assess risk for osteoporosis.
15810197|NCT04365478|Procedure|Radial Extracorporeal Shock Wave Therapy|rSWT group: One radial shock wave therapy session a week for 8 weeks (parameters: 1.5 bar, 10 Hz, 2000 shots for each muscle group treated) administered daily during the morning for 40 minutes of conventional rehabilitation treatment.
15810198|NCT04365478|Procedure|Conventional physiotherapy|Control group: 40-minutes of conventional rehabilitation treatment 5 days per week in the morning (strength exercise, trunk control exercise, stretching exercise, occupational therapy, and neurodevelopmental facilitation techniques) for 8 weeks
15810199|NCT04365465|Device|NSS-2 Bridge|The NSS-2 BRIDGE (Appendix 1) is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs.
15810200|NCT04365465|Device|Inactive NSS-2 Bridge|This is a sham device which is identical to the active NSS-2 Bridge, but will not provide percutaneous auricular nerve field stimulation when applied.
15810201|NCT04365465|Other|Active control|Active control will include standard of care pain management during the postoperative period. Participants in this intervention arm will not receive or wear a device.
15810202|NCT04365452|Device|Invia Motion|Invia Motion NPWT system at cesarean delivery
15810203|NCT04365439|Biological|Blood plasma|Convalescent plasma after COVID-19
15810204|NCT04365426|Device|Mechanical stimulus|Electrical dynamometer to measure mechanical pressure
15810205|NCT04365426|Procedure|Thermal (cold) stimulus|Water cold bath
15810206|NCT04365426|Other|Oral contraceptive (OC)|Oral contraceptive (OC)
15810207|NCT04365426|Other|No oral contraceptive (No OC)|No oral contraceptive (No OC)
15810208|NCT04365413|Device|MSOT Device|The MSOT Device will be used to take images of the tumor and/or lymph nodes of patients with solid tumors before and after surgery to measure the margins of the tumor and/or positive lymph node.
15810209|NCT04365413|Procedure|Temperature Measurement|The temperature of the skin will be measured prior to and after MSOT imaging.
15810210|NCT04365400|Drug|DS102|DS102 capsules
15810211|NCT04365400|Drug|Placebo|Placebo capsules
15810212|NCT04365387|Drug|Nemolizumab|Nemolizumab will be administered by 2 SC injections as 60-mg loading dose at baseline and a single 30-mg dose at Weeks 4, 8, and 12.
15810213|NCT04365387|Drug|Placebo|Placebo will be administered by 2 SC injections at baseline and a single dose at Weeks 4, 8, and 12.
15810214|NCT04365374|Device|Gamma Tile-Surgically Targeted Radiation Therapy (STaRT)|GammaTiles are a permanently implanted radiation device consisting of Cs-131 seeds positioned within a collagen tile
15810215|NCT04365374|Radiation|Stereotactic Radiation Therapy|External Beam Radiation Therapy
15810216|NCT04365335|Behavioral|Assessment of work-related stress|Assessment of burnout, mindfulness, interoceptive awareness, anxiety, post-traumatic stress disorder, coping flexibility and sleep through questionnaires.
15810217|NCT04365335|Biological|Saliva sample collection|Saliva sample is collected before and after emotional stimulation in order to measure resting-state allostatic load biomarkers: DHEA, cortisol and chromogranine A levels
15810218|NCT04365335|Other|Cardiac and electrodermal recordings|Electrocardiogram and electrodermal activity (tonic and phasic) is collected at rest and after emotional stimulation.
15810219|NCT04365335|Behavioral|Assessment of behavioral response to emotional stimulation|"Emotional stimulation involves asking the participants to remember a recent event related to the COVID-19 crisis that has been emotionally difficult for them.
~Perceived stress, situational awareness and emotions is assessed after emotional stimulation through questionnaires."
15810220|NCT04365322|Other|Additional biological samples|Peripheral Blood Mononuclear Cell (PBMC) and plasma will be collected.
15810221|NCT04365309|Drug|Aspirin 100mg|on the bases of standard treatment for the COVID-19, low-dose aspirin (100 mg/ day), orally，is added to.
15810222|NCT04365296|Other|Experimental|The purpose of the study is to evaluate which is more effective aerobic or resistance exercises in reducing plasma liver enzymes level (AST and ALT) post burn. Subjects and Methods: Sixty burned patients with burned body surface area about 30% to 50% will participate in this study. Their ages will be ranged from 20-45 years. They will be selected from Orabi Hospital and will be divided randomly into two equal groups.
15810223|NCT04365283|Procedure|New Bioactive Restorative Material (ACTIVA Presto)|New Bioactive Restorative Material
15810224|NCT04365283|Other|High Viscosity Glass Hybrid Reinforced Glass Ionomer (EQUIA Forte)|High Viscosity Glass Hybrid Reinforced Glass Ionomer
15810225|NCT04365270|Drug|Glass Ionomer|Glass ionomer filling material would be modified accordingly or used as is
15810226|NCT04365270|Drug|Chitosan Low Molecular Weight (20-200 Mpa.S)|deacetylated chitin, poly(D-glucosamine) purified by dissolving in 0.1 mol/L acetic acid, then precipitated in 0.1 mol/L sodium hydroxide and the precipitate will be washed with ethanol/water (70/30 v/v) mixture followed by freeze drying
15810227|NCT04365270|Drug|Chlorhexidine Diacetate|Chlorhexidine antibacterial effect to be compared by Sigma-aldrich PHR 1222 , lot#LRAB3716
15810228|NCT04365270|Drug|Titanium Dioxide|Titanium(IV) oxide,nanopowder, 21 nm primary particle size (TEM), >99.5% trace metals basis cat#718467 Lot#MKCB6332 Lot #MKCB6332
15810229|NCT04365257|Drug|Prazosin|Participants in this arm will receive the study drug as outlined in the arm description.
15810230|NCT04365257|Other|Standard of care|Participants in this arm will receive standard of care.
15810231|NCT04365231|Drug|Hydroxychloroquine and azithromycin treatment|"hydroxychloroquine 10-day course of hydroxychloroquine 200 mg tablet three times a day. To be taken orally.
~- azithromycin 5-day course of azithromycin 250 mg tablet twice a day on the first day of treatment, then once a day the 4 following days."
15810232|NCT04365231|Other|conventional management of patients|conventional management of patients
15810233|NCT04365218|Drug|MEDI8367|Subjects will receive subcutaneous (SC) single dose of MEDI8367, depending upon dose escalation strategy and Safety Review Committee results. The maximum dose will not exceed 600 mg. The dose will be administered as a single injection or multiple injections in the abdomen region.
15810234|NCT04365218|Drug|Placebo|Saline solution for injection and the placebo volume to be administered will be equivalent to the MEDI8367 volume administered for each dosing cohort.
15810267|NCT04364997|Drug|Desvenlafaxine Succinate Sustained-Release Tablet Placebo, Duloxetine Hydrochloride Enteric-coated Capsule|Desvenlafaxine Succinate Sustained-Release Tablet Placebo 50mg +Duloxetine Hydrochloride Enteric-coated Capsule 60mg orally once daily for 8 weeks,
15810268|NCT04364997|Drug|Duloxetine Hydrochloride Enteric-coated Capsule Placebo|Duloxetine Hydrochloride Enteric-coated Capsule Placebo 30 mg orally once daily for 1 week after 8-weeks treatment.
15810235|NCT04365205|Procedure|Endobronchial biopsy|Endobronchial biopsies will be collected following a standardized procedure based on established guidelines. Before the procedure, asthmatic subjects will receive 400 μg of salbutamol with the aid of an aerosol chamber to open up the airways before the procedure. Anesthesia of the upper airways will be achieved with lidocaine 5% spray. The total amount of lidocaine per subject is limited to 225 mg. General anesthesia will be obtained using propofol (average dose of 1.5 to 2 mg/kg). The fiberoptic bronchoscope (Pentax BF 15V, Argenteuil, France) is introduced and 8 to 10 biopsies will be taken from the middle lobe and the lower right lobe. Standard procedures such as bronchial brushing and bronchial fluid aspiration will also be performed. The duration of bronchoscopy is 15 minutes to 30 minutes. After the procedures, subjects will receive a short acting bronchodilator if required.
15810236|NCT04365192|Device|I-gel|"The i-gel airway is a supraglottic airway management device made of thermoplastic elastomer, which is soft, gel-like, and transparent.
~The i-gel has evolved as a device that accurately positions itself over the laryngeal framework, providing a reliable perilaryngeal seal, and therefore no cuff inflation is necessary."
15810237|NCT04365192|Device|Self-pressurized air-Q|The self-pressured air-Q is a supraglottic airway management device The intracuff pressure of air-Q dynamically equilibrates with the airway pressure and adjusts to the patient's pharyngeal and periglottic anatomy, potentially providing improved airway fit and seal.
15810238|NCT04365179|Drug|Nerofe|"Up to 12 cycles of 28 days are planned. If patients are deriving benefit, treatment may continue past 12 cycles.
~Cycle 1: During Cycle 1, assigned NEROFE doses will be administered by intravenous (IV) infusion over 1 hour on Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26.
~Cycles 2-12: Subsequent cycles will be administered as above, presuming that patients do not meet criteria for study withdrawal during cycle 1."
15810239|NCT04365153|Drug|Canakinumab Injection 600mg|Subjects will be given one-time intravenous infusion of 600 mg of canakinumab (8 mg/kg for patients </= 40 kg) in 250 mL of 5% dextrose infused IV over 2 hours
15810240|NCT04365153|Drug|Canakinumab Injection 300mg|Subjects will be given one-time intravenous infusion of 300 mg of canakinumab (4 mg/kg for patients </= 40 kg) in 250 mL of 5% dextrose infused IV over 2 hours
15810241|NCT04365153|Drug|Placebos|250 mL of 5% dextrose infused IV over 2 hours
15810242|NCT04365127|Drug|Progesterone 100 MG|Subcutaneous administration twice daily
15810243|NCT04365114|Diagnostic Test|Breast Screening Mammography with single reader|One clinician examined each woman's mammograms for signs of cancer
15810244|NCT04365114|Diagnostic Test|Breast screening mammography with two readers|Two clinicians seperately examined each woman's mammograms for signs of cancer
15810245|NCT04365114|Diagnostic Test|Test threshold|Threshold used by readers examining the breast screening mammograms, defined using their previous proportion of cases recalled
15810246|NCT04365101|Biological|CYNK-001|CYNK-001 is an allogeneic off the shelf cell therapy enriched for CD56+/CD3- NK cells expanded from human placental CD34+ cells.
15810247|NCT04365088|Drug|Deflazacort 30 MG Oral Tablet|After the taken a deflazacort pill once preoperatively (one hour ago), local anesthesia was obtained using 2 ml articaine hydrochloride 40 mg/ml with epinephrine 0.01 mg/ml . The horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under sterile saline irrigation. Following the extraction, granulation tissues were removed, and bleeding was controlled. Finally, the mucoperiosteal flap was repositioned by 3.0 silk sutures.
15810248|NCT04365088|Drug|Sugar pill|Sugar pill
15810249|NCT04365075|Device|Excimer Laser Combined with DCB|Using excimer laser combined with drug-coated baloons to treat infrapopliteal lesions in patients with critical limb ischemia.
15810250|NCT04365075|Device|Angioplasty Alone|Using angioplasty alone to treat infrapopliteal lesions in patients with critical limb ischemia.
15810251|NCT04365062|Device|Excimer laser and drug coated balloon|Excimer laser and drug coated balloon
15810252|NCT04365062|Device|Excimer laser and plain balloon|Excimer laser and plain balloon
15810253|NCT04365062|Device|plain balloon and drug coated balloon|plain balloon and drug coated balloon
15810254|NCT04365049|Radiation|Radiotherapy|Concurrent external beam radiation will be initiated after one course of anti-PD-1 treatment. The total radiation dose is over 40Gy without damaging organic function. Conventional intensity-modulated radiotherapy or stereotactic body radiation therapy are both allowed.
15810255|NCT04365049|Combination Product|Gemcitabine+cisplatin|Cisplatin 25mg/m2 intravenously (day 1 and day 8) and then gemcitabine 1000mg/m2 intravenously (day 1 and day 8) every 3 weeks (1 cycle), for 8 cycles.
15810256|NCT04365049|Drug|Anti PD-1|Patients will receive anti-PD-1 antibody intravenously every three weeks until disease progression, unacceptable toxicity, death or withdrawal.
15810257|NCT04365049|Drug|Apatinib|Patients will receive apatinib 250mg per day until disease progression, unacceptable toxicity, death or withdrawal.
15810258|NCT04365036|Drug|Toripalimab|toripalimab 240mg, d1, intravenous drip
15810259|NCT04365036|Drug|Pegaspargase|pegaspargase, 2000U/m2, d1, intravenous drip
15810260|NCT04365036|Drug|Gemcitabine|gemcitabine, 1000mg/m2, d1,d8, intravenous drip
15810261|NCT04365036|Drug|Oxaliplatin|oxaliplatin, 130mg/m2, d1, intravenous drip,
15810262|NCT04365036|Radiation|Definitive intensity-modulated radiotherapy (IMRT)|Definitive intensity-modulated radiotherapy (IMRT) of 54-56Gy will be given in 25~26 days
15810263|NCT04365023|Drug|platinum chemotherapy|First line platinum chemotherapy
15810264|NCT04365010|Drug|Sodium Bicarbonate Ringer's Injection|For each month of the trial, participating ICUs were assigned to use either Sodium Bicarbonate Ringer's Injection or 0.9% Saline for any intravenous administration of isotonic crystalloid. ICUs were randomly assigned to use Sodium Bicarbonate Ringer's Injection during even-numbered months and 0.9% Saline during odd-numbered months, or vice versa.
15810265|NCT04365010|Drug|0.9% Sodium Chloride Injection|For each month of the trial, participating ICUs were assigned to use either Sodium Bicarbonate Ringer's Injection or 0.9% Saline for any intravenous administration of isotonic crystalloid. ICUs were randomly assigned to use Sodium Bicarbonate Ringer's Injection during even-numbered months and 0.9% Saline during odd-numbered months, or vice versa.
15810266|NCT04364997|Drug|Desvenlafaxine Succinate Sustained-Release Tablet , Duloxetine Hydrochloride Enteric-coated Capsule Placebo|Desvenlafaxine Succinate Sustained-Release Tablet 50 mg+Duloxetine Hydrochloride Enteric-coated Capsule Placebo 60 mg orally once daily for 8 weeks.
15810269|NCT04364997|Drug|Duloxetine Hydrochloride Enteric-coated Capsule|Duloxetine Hydrochloride Enteric-coated Capsule 30mg orally once daily for 1 week after 8-weeks treatment.
15810270|NCT04364984|Drug|Angiotensin converting enzyme inhibitor|routine drug intake
15810271|NCT04364971|Procedure|singleradius and multiradius total knee arthroplasty|singleradius and multiradius total knee arthroplasty
15810272|NCT04364958|Other|A web based-Patient Decision Aid (PtDA) (shown on the computer)|Patient decision aids (PtDAs) are tools that assist patients in making health decisions, when there is uncertainty about treatment choice, incorporating their personal preferences and values about the available treatment options. This PtDA will include information about GAD symptoms, diagnosis, causes, and benefits and risks associated to psychological and pharmacological treatments for GAD (based on the Clinical Practice Guidelines-GAD). It will also include a values clarification exercise, in which patients will have to rate the importance attributed to the different aspects of treatments (e.g., mode of administration, benefits, risks, time to improvement, probability of relapse).
15810273|NCT04364958|Other|A web-based fact sheet (one page shown on the computer) with general information on mental health as a part of usual care.|Patients in the control group will receive a fact sheet (one page) with general information on mental health as a part of usual care provided by the Canary Islands Health Service.
15810274|NCT04364945|Drug|dexmedetomidine|administration of dexmedetomidine 1 mcg/kg/hr
15810275|NCT04364945|Drug|remifentanil|administration of remifentanil 0.1-0.2 mcg/kg/min
15810276|NCT04364945|Drug|Sevoflurane|Anesthesia is maintained using sevoflurane.
15810277|NCT04364919|Behavioral|aerobic exercise program|"The program incorporated modified yoga movements suitable for pregnant women. The DVD provides an illustration with the written caption, Please take enough water before exercise, and wear loose and comfortable clothes in a suitable environment. If you feel tired, stop exercising immediately. The DVD's narrator then says, Now you are ready to prepare a comfortable, solid chair with a chair back. With a soft musical background, the exercise actions were arranged in following order: warm-up → neck → shoulder → arm → chest → waist →leg → regulating the breathing. The first 14.5 minutes of the yoga exercises were performed in a sitting position, followed by 3.5 minutes in standing position, and then returning to 2 minutes in sitting position. The exercises were developed as a progressive program in order to achieve the goals of strength-conditioning, moderate-intensity exercise (ACOG, 2015)."
15810278|NCT04364906|Other|Regional anesthesia|The effects of QLB 2, 3 interfascial plane blocks on post-operative analgesia after cesarean section surgery
15810279|NCT04364893|Other|Suspension or Maintenance of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors|Suspension or Maintenance of Angiotensin Receptor Blockers and Angiotensin-converting Enzyme Inhibitors
15810280|NCT04364880|Device|TBS|Theta-burst stimulation (TBS) is a novel repetitive transcranial magnetic stimulation (rTMS)
15810281|NCT04364880|Device|Sham|The sham-TBS coil produced a similar sound without a magnetic pulse.
15810282|NCT04364867|Drug|Exparel|Single shot Exparel 10cc (133mg) mixed with 10cc of 0.5% Bupivicaine
15810283|NCT04364867|Drug|Pain Pump|Subject will receive an interscalene block with Ropivicaine 0.5% (20cc), and then a pain pump attached in the PACU infusing at 4cc/hr. The patient will go home with that device until it runs out.
15810284|NCT04364854|Behavioral|SET (Speech Entrainment Therapy) 3 weeks|3 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program
15810285|NCT04364854|Behavioral|SET (Speech Entrainment Therapy) 4.5 weeks|4.5 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program
15810286|NCT04364854|Behavioral|SET (Speech Entrainment Therapy) 6 weeks|6 weeks of SET which consists of practicing fluent speech in real time with an audio-visual computer program
15810287|NCT04364854|Other|No Therapy 6 Weeks|Participants will not be getting any SET for 6 weeks
15810288|NCT04364828|Genetic|Whole Genome Analysis|Whole Genome Analysis with whole transcriptome analysis and deoxyribonucleic acid (DNA) methylation analysis using Methylation beadchip (EPIC) arrays
15810289|NCT04364828|Genetic|T-cell receptor (TCR) repertoire|Longitudinal analysis of TCR repertoire of Cluster of Differentiation 4+ (CD4+) and CD8+ T cells from blood samples (Peripheral Blood Mononuclear Cells, PBMCs) from clinically characterized patients
15810290|NCT04364828|Genetic|SARS-CoV-2 viral composition|Determined by Next Generation sequencing
15810291|NCT04364815|Drug|Hydroxychloroquine plus standard preventive measures|Hydroxychloroquine and standard preventive measures
15810292|NCT04364815|Drug|Placebo plus standard preventive measures|Placebo tablet plus standard preventive measures as defined by PGH-HICU
15810293|NCT04364802|Drug|Povidone-Iodine Nasal Spray and Gargle|Healthcare workers will receive standard PPE and a pre- and post-study nasal swab COVID19 test. Additionally, they will receive povidone-iodine nasal spray and gargle (10% diluted 1:30) to use at the beginning of their shift, in the middle, and at the end of their shift.
15810294|NCT04364802|Drug|Povidone-Iodine Nasal Spray and Gargle|Patients will receive standard of care treatment and a pre- and post-study nasal spray COVID19 test. Additionally, they will receive povidone-iodine nasal spray and gargle shortly after admission or preoperatively.
15810295|NCT04364802|Drug|Povidone-Iodine Nasal Spray and Gargle|Community members will receive a pre- and post-study nasal swab COVID19 test. Additionally, they will receive povidone-iodine nasal spray and gargle (10% diluted 1:30) to use at home.
15810296|NCT04364789|Drug|TT-00920|Specified dose on Specified days
15810297|NCT04364789|Drug|Placebos|Specified dose on Specified days
15810298|NCT04364776|Drug|Durvalumab|In this observational study, durvalumab will be administered according to current indications (PACIFIC phase III trial).
15810299|NCT04364763|Drug|RBT-9 (90 mg)|Subjects will receive a single dose and study duration will be approximately 60 days per subject.
15810300|NCT04364763|Drug|0.9% sodium chloride (normal saline)|Subjects will receive a single dose and study duration will be approximately 60 days per subject.
15810301|NCT04364750|Dietary Supplement|L-Histidine|1 capsule (0.6g) twice daily
15810302|NCT04364750|Dietary Supplement|High-FODMAP beverage|High-FODMAP beverage (10g of fermentable carbohydrates) consumed twice daily.
15810303|NCT04364750|Dietary Supplement|Low-FODMAP beverage|Low-FODMAP beverage (10g glucose) consumed twice daily.
15810304|NCT04364750|Dietary Supplement|Lactobacillus acidophilus CL1285, L. casei LBC80R and L. rhamnosus CLR2.|Total of 50 billion CFU/capsule taken twice daily.
15810306|NCT04364737|Biological|Convalescent Plasma|SARS-CoV-2 convalescent plasma (1-2 units; ~250-500 mL) with antibodies to SARS-CoV-21 per April 13, 2020 directive by the FDA, obtained from New York Blood Center will be administered to eligible candidate
15810307|NCT04364737|Other|Saline solution|Equivalent volume of saline solution (defined as half-,quarter-, or normal saline) will be administered to eligible candidate as a placebo control group.
15810308|NCT04364724|Other|CT-based finite element analysis|"CTFEA is a computerized analysis of CT-scans which simulates stress testing of finite element models of various bones (in this study - femurs and vertebrae).
~No intervention is planned - the study is observational. CT scans are performed for follow-up as an accepted standard of care. Secondary use of CT scans for CTFEA is in addition to the standard of care.
~In a case when CTFEA analysis detects a high risk of pathologic fracture, the treating hematologist will be informed and will refer the patient for evaluation at the National Unit of Orthopedic Oncology."
15810309|NCT04364685|Other|Walking on soft-sand|The participants are required to walking on sand for 30 minutes. Walking is self-paced.
15810310|NCT04364685|Other|Walking on Levelled Surface|The Participants will be require to walk on the firm surface for 30 minutes. The participants would decide the pace of walking.
15810311|NCT04364672|Drug|[11C]PiB and 18F-labeled DPA-714 PET scan|One PET with [11C]PiB and One PET with [18F]DPA-714 before chemotherapy treatment begins. One more PET with [18F]DPA-714 after completion of 3-6 cycles of chemotherapy.
15810312|NCT04364659|Behavioral|Food-Specific Inhibitory Control Training (FoodT App)|FoodTrainer (FoodT) is a simple game that aims to train individuals to 'stop' to certain unhealthy foods. Repeatedly playing this game is hypothesised to help build associations between certain foods (such as chocolate) and stopping, putting the brakes on unhelpful eating behaviour.
15810313|NCT04364646|Behavioral|Personalized Integrated Chronotherapy|Based on their baseline sleep-wake schedule and real-life constraints (work and other responsibilities), an initial sleep schedule is set that allows 7.5 hours of sleep and provides time for participants to sit in front of the morning bright light.
15810314|NCT04364633|Other|Voice Handicap Questionnaire (VHI)|Voice Handicap Index (VHI) self-questionnaire
15810315|NCT04364620|Drug|AB-16B5|AB-16B5 is an inhibitor of the epithelial to mesenchymal transition. It is a fully humanized monoclonal antibody of IgG2 isotype against tumor-associated secreted clusterin (TA-sCLU).
15810316|NCT04364620|Drug|Docetaxel|Docetaxel is an anticancer chemotherapy drug approved in the treatment of non-small cell lung cancer
15810317|NCT04364607|Drug|Neostigmine|Participants will receive 0.5 mg IM neostigmine
15810318|NCT04364607|Drug|NaCl 0.9%|Participants will receive IM NaCl 0.9% as a placebo
15810319|NCT04364594|Diagnostic Test|conjunctival swab|analysis of conjunctival cells (real time PCR) collected by conjunctival swabs in both eyes
15810320|NCT04364581|Drug|Letrozole|Women will be treated with letrozole (5 mg daily) for 10 days before hysteroscopic intervention
15810321|NCT04364581|Drug|Placebo|Women will be treated with placebo for 10 days before hysteroscopic intervention
15810322|NCT04364568|Radiation|Magnetic Resonance Imaging|IRM Sequences T1, T2, FLAIR, T2*, Cerebral Blood Flow (CBF) et mean diffusivity (MD)
15810323|NCT04364555|Drug|Clobetasol Propionate|Klobetasol APL oral gel 0.025% is a topical steroid for rinsing the oral cavity. Manufactured by APL, Sweden.
15810324|NCT04364555|Drug|Placebo/active|Placebo/active
15810325|NCT04364555|Drug|Placebo/placebo|Placebo/placebo
15810326|NCT04364542|Procedure|Suprascapular nerve block|The patient lies supine in beach chair position with surgical drapes on. The anatomical landmarks are outlined and the infiltration spot is identified. The block is performed with 10 ml ropivacaine 0.75%.
15810327|NCT04364542|Procedure|Interscalene Nerve Block|The patient lies supine position with the head turned to the contralateral side to the block. A linear high-frequency ultrasound probe is used for identifying the roots of supraclavicular brachial plexus using the traceback technique. The block is performed with 15 ml ropivacaine 0.5%.
15810328|NCT04364542|Procedure|Arthroscopic rotator cuff repair|Conventional arthroscopic rotator cuff repair.
15810329|NCT04364529|Other|The pit crew model|The pit crew model
15810330|NCT04364516|Drug|Anticoagulation|Study of prognostic impact according to oral anticoagulation therapy (Vitamin K Antagonists or Direct Oral Anticoagulants)
15810331|NCT04364503|Device|Multiple interventions depending on diagnostic test being run.|Remnant samples and corresponding data from multiple diagnostic tests will be stored for future research and development.
15810332|NCT04364490|Device|Copernicus noVF|Advanced gait training sessions by the computerized BWS system, named Copernicus®, without visual feedback.
15810333|NCT04364490|Device|Copernicis VF-Plus|Advanced gait training session with the addition of visual feedback ensuring a real-time interactive control of locomotor performance.
15810334|NCT04364490|Other|Control group|Usual care
15810335|NCT04364477|Procedure|transversus abdominis plane (TAP) block|The transversus abdominis plane (TAP) block is a regional anesthesia technique described in recent years that provides analgesia for the anterior portion of the abdominal wall after abdominal surgery.
15810336|NCT04364464|Drug|Riociguat (Adempas, BAY 63-2521)|0.5 mg riociguat as an immediate-release (IR) tablet
15810337|NCT04364451|Other|Correlation of Polymorphisms of Lipoprotein Lipase (LpL) and Apolipoprotein E (Apo E) With Lipid Profile of Children With Acute Lymphoblastic Leukaemia During Therapy With L - Asparaginase|Children that meet all the inclusion criteria for this study will be examined and undergo treatment with asparaginase (Experimental group) and will be compared to the corresponding teams of healthy children and children that have ailed and are off chemotherapy for at least 6 months (Control group).
15810338|NCT04364438|Device|Electric Muscle Stimulation|EMS is believed to produce some inhibition of the bladder, allowing the bladder to reach a greater volume. This is believed to occur because electrical stimulation also stimulates nerves in the pelvic floor. In most people, bladder voiding is inhibited when the skin of the pelvis is touched or otherwise manipulated. This inhibition is via a reflex in the spinal cord that may have evolved to inhibit voiding during sexual contact. The pelvic floor nerves are responsible for transmitting the sensation of touch from the pelvis to the spinal cord. Electrical stimulation of these nerves thus activates sensory fibers that cause inhibition of bladder voiding via a reflex mechanism in the spinal cord. This may explain EMS is an effective treatment for people with incontinence.
15810468|NCT04363450|Drug|Placebo|Loading dose of two placebo capsules twice 12 hours apart followed by 1 capsule twice weekly
15810339|NCT04364438|Device|Transcutaneous Electric Nerve Stimulation|TENS is based on the gate control theory of abolishing the local micturition reflex arc. It is a non-pharmacological method of inhibiting the presynaptic afferent neurons carrying impulses from bladder by stimulating the nerves of peripheral segmental dermatome (gate control theory of electro modulation by stimulating the peripheral nerves corresponding to the visceral organ). It acts at the level of primitive voiding reflex coordinating the bladder, sphincter and the pelvic floor. Detrusor hyperreflexia can be inhibited by direct inhibition of impulses in the preganglionic afferent neuron or by inhibition of bladder preganglionic neurons of the efferent limb of micturition reflex.
15810340|NCT04364425|Drug|Triamcinolone Acetonide|ultrasound guided steroid injection using 1ml of 10mg or 4ml of 40mg triamcinolone acetonide
15810341|NCT04364425|Drug|lidocaine hydrochloride|Ultrasound guided injection using 4ml of 2% lidocaine hydrochloride (Xylocaine)
15810342|NCT04364425|Drug|Normal saline|Ultrasound guided injection using 15ml or 12 ml of normal saline
15810343|NCT04364399|Biological|Mumps vaccine|One dose of mumps vaccine: 0.5 ml per dose, mumps live virus not less than 3.7 lg CCID50
15810344|NCT04364399|Biological|measles, mumps and rubella combined vaccine, live|One dose of measles, mumps and rubella combined vaccine, live: 0.5 ml per dose, mumps live virus not less than 4.3 lg CCID50
15810345|NCT04364386|Device|InPress Device|Treatment with InPress Device for Postpartum Hemorrhage
15810346|NCT04364373|Procedure|Left colon resection|"This procedure is performed for tumours in splenic flexure and proximal and descending colon.
~Left colic artery is divided at its origin. Sigmoid arteries and superior rectal arteries are preserved. Inferior mesenteric vein is divided at the lower border of the pancreas. The colon is divided about 10 cm proximal and distal to the tumour. Mesocolic fascia is preserved and the length of the vessel trunk of the mesocolon corresponds to the level of lymph node dissection. After removal of the resected colonic segment a handsewn or stapler end-to-end or side-to-side colonic anastomosis is performed."
15810347|NCT04364373|Procedure|Sigmoid colon resection|"This procedure is performed for tumours in sigmoid colon. Corresponding sigmoid arteries are divided at their origin. Left colic artery and superior rectal artery are preserved. Inferior mesenteric vein is divide close to the left colic artery. Proximal and distal margin compose 10 cm from the tumour. Mesocolic fascia is preserved and the length of the vessel trunk of the mesocolon corresponds to the level of lymph nodes dissection. After removal of the resected colonic segment a handsewn end-to-end or side-to-side or stapler colonic anastomosis is performed."
15810348|NCT04364373|Procedure|Distal sigmoid colon resection or anterior resection|"This procedure is performed for tumours in distal sigmoid colon or rectosigmoid junction. Superior rectal artery is divided below the origin of left colic artery. Left colic artery is preserved. Inferior mesenteric vein is divide close to the left colic artery. The colon is divided about 10 cm proximal and 5 cm distal to the tumour. Mesocolic fascia is preserved and the length of the vessel trunk of the mesocolon corresponds to the level of lymph node dissection. After removal of the resected colonic segment handsewn or stapler colo-rectal anastomosis is performed."
15810349|NCT04364360|Dietary Supplement|Sulforaphane extract|2x BroccoMax® capsules day, giving a total daily dose of 30 mg of Sulforaphane Glucosinolate Per day
15810350|NCT04364321|Drug|Clonazepam 0.5 MG|Clonazepam 0.02 mg/kg only one dose
15810351|NCT04364321|Drug|Diazepam Tablets|Diazepam 0.3 mg/kg every 8 hours for 3 doses. (24 hr)
15810352|NCT04364308|Other|Fetal Echography|Fetal ultrasound and its parameters
15810353|NCT04364295|Procedure|Spinal Surgery|Implanted with SeaSpine spinal or orthobiologic product
15810354|NCT04364269|Drug|VIT-2763 once a day (QD)|Participants will receive VIT-2763 QD at a dose of 60 mg if their body weight is between 40 kg to 59 kg or at a dose of 120 mg if their body weight is between 60 kg and 100 kg, during 12 weeks.
15810355|NCT04364269|Drug|VIT-2763 twice a day (BID)|Participants will receive VIT-2763 BID at a dose of 60 mg if their body weight is between 40 kg to 59 kg or at a dose of 120 mg if their body weight is between 60 kg and 100 kg, during 12 weeks.
15810356|NCT04364269|Drug|Placebo|Participants will receive hard capsules of Placebo, twice a day.
15810357|NCT04364256|Device|RS-4i Plus Sequential Stimulator (RS Medical, Vancouver, WA)|Active or Sham Neuromuscular electrical stimulation. US Food and Drug Administration-approved 2012
15810358|NCT04364243|Other|Digitally supported home exercises|The training will comprise of 9 sessions (3 weekly) Each of the training sessions will last 20 minutes. This will result in a cumulative total intervention exercise time of 180 minutes.
15810359|NCT04364230|Drug|6MHP|6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
15810360|NCT04364230|Drug|NeoAg-mBRAF|BRAF 586-614 (V600E) peptide to which a histidine has been added to the N-terminus, resulting in BRAF 585-614 (V600E).
15810361|NCT04364230|Drug|PolyICLC|polyICLC, local adjuvant
15810362|NCT04364230|Drug|CDX-1140|CDX-1140, local adjuvant
15810363|NCT04364217|Device|Luminis ultrapulse fractional ablative carbon dioxide laser|This laser will target water molecules and ablate columns of tissue that are approximately 3mm deep.
15810364|NCT04364204|Other|Kangaroo Mother Care and BEMPU bracelet|Kangaroo mother care involves early, continuous and prolonged skin-to-skin contact between a mother and her newborn, frequent and exclusive breastfeeding and early discharge from hospital. The BEMPU bracelet, also known as the BEMPU Tempwatch, is a silicone band with a thermistor metal cup that emits an audio alarm and flashes an orange light when the body temperature drops below 36.5⁰C, signaling hypothermia and prompting caregiver to provide thermal care.
15810365|NCT04364204|Other|Kangaroo Mother Care|Kangaroo mother care involves early, continuous and prolonged skin-to-skin contact between a mother and her newborn, frequent and exclusive breastfeeding and early discharge from hospital. This is the current standard of care for low birthweight/preterm infants.
15810366|NCT04364191|Behavioral|Multicomponent Behavioral Sleep Intervention for Insomnia|The MBSI-I will include a meaningful activity protocol during the day and ART therapy at night.
15810367|NCT04364191|Behavioral|Active Control|The sleep hygiene educational material represents an active control intervention and is recommended as part of the initial treatment of insomnia based on an NIH guide for sleep education.
15810368|NCT04364178|Biological|Adenovirus Specific T- Lymphocytes|Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Adenovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
15810369|NCT04364178|Biological|Cytomegalovirus Specific T-Lymphocytes|Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Cytomegalovirus viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
15810370|NCT04364178|Biological|Epstein-Barr Virus Specific T-Lymphocytes|Peripheral blood mononuclear cells will be collected from the donor and loaded onto our Miltenyi Biotec CliniMACS Prodigy® or CliniMACS® Plus where they will be stimulated in vitro with Epstein-Barr viral-specific antigen(s). The cells are then immunomagnetically labeled with interferon gamma via the cytokine capture system, captured and infused.
15810371|NCT04364165|Behavioral|Standard invitation to free HIV testing at mobile clinic|Participants receive standard invitation to same day HIV testing at mobile clinic.
15810372|NCT04364165|Behavioral|U=U messaging and invitation to free HIV testing at mobile clinic|Participants receive messaging about being undetectable equals untransmittable (U=U) and invitation to same day HIV testing at mobile clinic.
15810373|NCT04364152|Behavioral|Dual-task walking training|Participants will be instructed to perform both motor and cognitive dual-task walking during exercise training. For example, for motor dual-task walking, the participants may be instructed to throw and catch a ball while walking. As for cognitive dual-task walking, the participants may be instructed to name animals or perform calculation while walking.
15810374|NCT04364139|Other|MAP goal less than or equal to 92 mm Hg|Lower Blood Pressure Goal (mean arterial pressure (MAP) less than or equal to 92 mm Hg) which corresponds to a BP of approximately 115/80 mmHg
15810375|NCT04364139|Other|MAP goal 102-107 mm Hg|Usual Blood Pressure Goal (mean arterial pressure (MAP) 102-107 mm Hg) which corresponds to a BP of approximately 135/85 to 140/90 mmHg
15810376|NCT04364139|Drug|Ramipril|An angiotensin-converting enzyme inhibitor, (ACEI: ramipril) 2.5 to 10 mg/d
15810377|NCT04364139|Drug|Amlodipine|A dihydropyridine calcium channel blocker, (DHPCCB: amlodipine) 5 to 10 mg/d
15810378|NCT04364139|Drug|Metoprolol|A sustained release beta-blocker, (BB: metoprolol) 50 to 200 mg/d
15810379|NCT04364126|Device|Home blood pressure apparatus|Target <125/80 mmHg
15810380|NCT04364126|Other|Clinic blood pressure|Target <130/80 mmHg
15810381|NCT04364113|Other|Usual Protein Diet|The usual protein diet contains 1.30 g/kg/day protein and 16-20 mg/kg/day of Phosphorus
15810382|NCT04364113|Other|Low Protein Diet|The low protein diet contains 0.575 g/kg/day protein and 5-10 mg/kg/day of Phosphorus
15810383|NCT04364113|Other|Very Low Protein Diet|The very low protein diet contains 0.28 g/kg/day or protein, mg/kg/day of Phosphorus and a keto acid mixture.
15810384|NCT04364113|Drug|Medications needed to maintain usual blood pressure|The MAP goal for the usual blood pressure group is <=107 mm Hg for ages 18-60 and <=113 for ages 61+. Pharmacological and non-pharmacological therapies will be used to achieve the desired blood pressure values. The recommended anti-hypertensive regimen is a angiotensin-converting-enzyme inhibitor with or without a diuretic agent; a calcium-channel blocker or other medications can be added as needed.
15810385|NCT04364113|Drug|Medications needed to maintain low blood pressure|The MAP goal for the low blood pressure group is <=92 mm Hg for ages 18-60 and <=98 for ages 61+. Pharmacological and non-pharmacological therapies will be used to achieve the desired blood pressure values. The recommended anti-hypertensive regimen is a angiotensin-converting-enzyme inhibitor with or without a diuretic agent; a calcium-channel blocker or other medications can be added as needed.
15810386|NCT04364087|Diagnostic Test|Oral glucose tolerance test|Oral glucose tolerance test with 75 g glucose (75 g OGTT) will be performed to those with normal fasting glucose and HbA1C levels. Women will be recommended to have normal diet for 3 days and overnight fasting for at least 8 hours. The blood withdrawal will be performed twice: (i) fasting and (2i) 2 hours after solution administration. The volume of blood for each test is 2 ml. Impaired glucose tolerance will be diagnosed when two-hour glucose levels of 140 to 199 mg/dL (7.8 to 11.0 mmol/l) (American Diabetes Association, 2018).
15810387|NCT04364074|Dietary Supplement|Goodbelly|Consumption of 1 serving of Goodbelly probiotic daily for 6 weeks. This will be followed by an observation period for 6 weeks during which the subjects will not consume Goodbelly.
15810388|NCT04364074|Dietary Supplement|Placebo|To prepare the placebo, the dietitian will first heat a water bath to 80 degrees Celsius. This removes the lactobacillus plantarum 299v from the probiotic drink
15810389|NCT04364061|Other|Moderate Intensity Continuous Exercise|Participant completed a moderate intensity continuous cycling exercise (MICE) during 35 min at 60-65% thPHRmax
15810390|NCT04364061|Other|High-Intensity Interval Exercise (1)|Participant completed a high-intensity interval cycling exercise (HIIE 1) during 20min with 60 cycles of speeding up for 8s and pedaling slowly for 12s at 80-90% thPHRmax
15810391|NCT04364061|Other|High-Intensity Interval Exercise (2)|Participant completed a high-intensity interval cycling exercise (HIIE 2) during 20min with 10 x 1-min bouts at 80-90% thPHRmax, separated by 1-min recovery bouts
15810392|NCT04364048|Drug|Induction Durvalumab|Induction durvalumab at 1500 mg intravenously (IV) will be given on Day 1 of a four week cycle for 1 cycle,
15810393|NCT04364048|Drug|Chemotherapy|Concurrent chemoradiation will be with platinum-based chemotherapy (cisplatin or carboplatin, with etoposide, taxane, or pemetrexed) selected at the treating physician's discretion. The chemotherapy regimen used should be administered per institutional standards following the prescribing guidelines for each drug
15810394|NCT04364048|Radiation|Radiation|Treatment will be delivered using IMRT or 3DCRT using typically 6-10MV photons per institutional standards. 4D simulation and appropriate IGRT are encouraged. Radiation therapy must begin within one week of the first day of chemotherapy (or vice versa). Therapy will be 1.8-2 Gy per day; 5 days per week, excluding holidays per institutional standard as this is a standard of care regimen for this patient population. 54-66 Gy will be delivered.
15810395|NCT04364048|Drug|Consolidation durvalumab|Durvalumab at 1500 mg intravenously (IV) will be given on Day 1 of a four week cycle for 12 cycles
15810396|NCT04364035|Biological|ChAdOx1.HTI|ChAdOx1.HTI at week 0 and week 12; Vaccine delivered as one 0. 5 mL IM injection
15810397|NCT04364035|Biological|MVA.HTI|MVA.HTI at week 24 and week 36; Vaccine delivered as one 0. 5 mL IM injection
15810398|NCT04364035|Drug|GS-9620|GS-9620 at week 26,28,30,32,34,38,40,42,44 and 46 Unit-dose tablet, delivered as two 3-mg tablets
15810399|NCT04364035|Biological|Placebo|Saline placebo delivered as one 0. 5 mL IM injection
15810402|NCT04364009|Drug|Anakinra plus oSOC|"Anakinra plus Optimized Standard of Care (oSOC) on the condition of patients with COVID-19 infection and worsening respiratory symptoms.
~The patients will receive intraveinous injection of Anakinra 400mg from Day 1 to Day 3 (two injections of 100 mg each 12 hours) and 200mg the remaining 7 days. The total duration of Anakinra is 10 Days. Efficient dosage of Anakinra as previously described will be continued until Day 10"
15810403|NCT04364009|Drug|oSOC|Optimized Standard of Care (oSOC) on the condition of patients with COVID-19 infection and worsening respiratory symptoms.
15810404|NCT04363996|Other|New Bioactive Restorative Material|Filling material
15810405|NCT04363983|Biological|Blood sampling|"Blood collection (50 ml) will be performed for all patients at baseline, at 1 month post-operative for resected patients (+ at the end of neoadjuvant treatment / before surgery if patient receives neoadjuvant treatment), and at 2-3 months after the beginning of the treatments in patients with metastases (+ at each progression).
~Following analysis should be performed with
~serum for protein assays and characterization analysis of cytokines, new tumor markers and micro-RNA ...;
~plasma for protein assays and characterization analysis of micro-RNA, VEC (the content of proteins, RNA, micro-RNA and DNA) and metabolomics;
~PBMC for flow cytometry analysis, isolation macrophages;
~whole blood for circulating tumor DNA (mutations by NGS, ddPCR,…; methylation) and circulating tumor cells."
15810406|NCT04363983|Procedure|Liver biopsy|"An intraoperative liver biopsy will be performed at free edge of liver with a triangular sample for local resected patients.
~This biopsy will be done with scissors, then patients will receive intraoperative hemostasis with mono- or bipolar coagulation. This procedure will be under laparoscopy or laparotomy without extending standard processing time.
~This biopsy seeks to allow the evaluate liver modifications testifying the preparing for premetastatic niche, which would allow to identify the patients with risk for hepatic relapsing; the same analysis on the tumors will be performed."
15810407|NCT04363983|Biological|Stool collect|"Stool collection will be performed for all patients at baseline, at 1 month post-operative for resected patients (+ at the end of neoadjuvant treatment / before surgery if patient receives neoadjuvant treatment), and at 2-3 months after the beginning of the treatments in patients with metastases (+ at each progression).
~Analysis will be performed for microbiota and metabolism analysis."
15810408|NCT04363970|Other|removal of the urinary catheter|in group A, we will remove the catheter after 24 h. In group B, we will remove the catheter after 48 h.
15810409|NCT04363957|Other|Brachytherapy video|Patients will watch a video that contains information about brachytherapy
15810410|NCT04363957|Other|Standard Brachytherapy Consent Process|Patients will have the standard clinical brachytherapy consent and education including discussion with their physician.
15810411|NCT04363944|Device|mRehab|mRehab (mobile Rehab) was created to better support in-home upper limb rehabilitation programs. It incorporates a task-oriented approach and immediate performance-based feedback. mRehab consists of 3D-printed household items (a mug, bowl, key, and doorknob) integrated with a smartphone and an app. The app guides participants through practice of activities of daily living (ADL), for example, sipping from a mug. It can also consistently measure time to complete an activity and quality of movement (smoothness/accuracy) during the performance of ADLs. In each session of exercise participants receive feedback on the number of repetitions they complete for each activity, the average time to complete the activity and the average smoothness to perform the activity. Participants were trained in use of mRehab in lab visits and then took mRehab home to use the system. mRehab recorded longitudinal data.
15810412|NCT04363931|Procedure|Manual Therapy|Participants in this group received 4 weeks of manual therapy and massage of the masticatory muscles intra and extra orally together with massage of the cervical muscles. Massage and Manual Therapy brings about benefits by increasing local circulation and decreasing muscle tonus . Additionally, stretching exercises aiming to decrease pain and elongate shortened masticatory muscle fibers by autogenic inhibition of the masseter muscle were performed.
15810413|NCT04363931|Procedure|Kinesio Taping|Participants in this group had an application of Kinesio Taping on the masseter muscles. The material used for bruxism Kinesio Taping application was Kinesio Tex Gold Finger Prints (Kinesio Holding Corporation, Albuquerque, USA), a 100% cotton, latex-free, 5-cm wide, elastic tape. Kinesio Taping placement was chosen according to principles described by Kase et al. Tapes were cut 2.5 cm in width (cut in half vertically from 5 cm width). Two strips of Kinesio Tape were crossed over the masseter muscle area with 0-5% tension in maximum stretched epidermis position. Web-cut strips epidermis-dermis-fascia technique were used. Tape was applied bilaterally after every session of manual therapy.
15810414|NCT04363918|Device|bioelectric stimulation|bioelectric stimulation
15810415|NCT04363905|Dietary Supplement|Placebo|100 mg lactose per day for 6 weeks
15810416|NCT04363905|Dietary Supplement|Ferrous sulfate|20 mg per day of elemental iron for 6 weeks
15810417|NCT04363892|Other|Optical and infrared imaging|Acquiring images (photographs) of the skin
15810418|NCT04363879|Procedure|Endometrial scratch with Pipelle curette|For patients in the Pipelle curette group, physicians inserted the Pipelle curette into the uterus and removed an adequate endometrial sample using vigorous motion.
15810419|NCT04363879|Procedure|Endometrial scratch with Shepard catheter|For patients in the Shepard catheter group, physicians performed a four-quadrant scratch technique by inserting the Shepard insemination catheter into the uterus at 12:00. The catheter was then turned one-quarter turn and withdrawn. This was repeated two more times so that four endometrial quadrants were touched by the catheter at 12:00, 3:00, 6:00, and 9:00.
15810420|NCT04363866|Drug|Hydroxychloroquine|Hydroxychloroquine is more polar, less lipophilic, and has more difficulty diffusing across cell membranes than the parent compound, chloroquine. These characteristics result in hydroxychloroquine having a longer half-life, comparatively lower toxicity to chloroquine, as well as fewer concerns pertaining to drug-drug interactions
15810421|NCT04363866|Drug|Placebo|A placebo is a pill that looks like the study drug but has no real medicine in it.
15810422|NCT04363853|Drug|Tocilizumab|We study the impact of the administration of Tocilizumab on the evolution of the acute respiratory distress syndrome (ARDS) in patients with severe or critical SARS-CoV-2 infection.
15810423|NCT04363840|Drug|Aspirin 81 mg|Aspirin 81 mg to be taken orally once daily for 14 days.
15810424|NCT04363840|Dietary Supplement|Vitamin D|Vitamin D 50,000 IU to be taken orally once weekly for 2 weeks
15810425|NCT04363827|Drug|Hydroxychloroquine|Hydroxychloroquine
15810538|NCT04362800|Other|3D and EMG analysis|3D and EMG analysis at baseline and J90
15810426|NCT04363814|Biological|Bactek-R|BACTEK-R is a bacterial preparation that contains a mixture of Gram + and Gram - inactivated bacteria at the concentration of 300 FTU / mL (approx. 10^9 bacteria / mL)
15810427|NCT04363801|Drug|DKN-01 300mg|Administered by IV infusion
15810428|NCT04363801|Drug|DKN-01 600mg|Administered by IV infusion
15810429|NCT04363801|Drug|Tislelizumab 200mg|Administered by IV infusion
15810430|NCT04363801|Drug|Oxaliplatin 130mg/m2|Administered by IV infusion
15810431|NCT04363801|Drug|Capecitabine 1000mg/ m2 BID|Administered orally
15810432|NCT04363788|Procedure|double gloves|The study was based on dying gloves used during resuscitation. The gloves were secured with disposable hermetically sealed pouches and described by one of the EMS team members - each time after resuscitation was completed.
15810433|NCT04363775|Device|The standard Macintosh laryngoscope|intubation with the standard Macintosh laryngoscope and endotracheal tube 7.0 internal diameter with standard tube stylet
15810434|NCT04363775|Device|The Vie Scope laryngoscope|intubation with the Vie Scope laryngoscope with bougie stylet and endotracheal tube 7.0 internal diameter
15810435|NCT04363762|Behavioral|Internet-based multimodal pain program|A guided internet-based multimodal pain program for chronic TMD pain
15810436|NCT04363762|Device|Occlusal splint|Occlusal splint, standard
15810437|NCT04363749|Other|hypoxia : 14.3 and 12.7% FIO2, hypercapnia 7% CO2, inspiratory mechanical constraint|the fraction of inspired oxygen is reduced from ~21% (room air) to 14.3 and 12.7% allowing the SpO2 to decrease to ~75%, rebreathing test allowing the PCO2 to rise to 65 mmHg, inspiratory mechanical constraint with 50 to 75% of maximum inspiratory pressure
15810438|NCT04363736|Drug|Tociliuzumab|Participants will receive IV TCZ.
15810439|NCT04363723|Other|Pulmonary Rehabilitation|Patients performed a comprehensive pre-lung transplant inpatient pulmonary rehabilitation program for 4 to 5 weeks duration.
15810440|NCT04363710|Other|Low Calorie Diet|800-1000 Kcal/day
15810441|NCT04363697|Drug|Dapagliflozin|Dapagliflozin
15810442|NCT04363697|Drug|Placebo|Matched placebo
15810443|NCT04363645|Other|Multicontext (MC) approach|The Multicontext approach is a metacognitive intervention designed to improve awareness, strategy use, and executive functioning.
15810444|NCT04363619|Diagnostic Test|OCT and OCTA|Fundoscopy, OCT and OCTA will be performed 4 times in patients
15810445|NCT04363606|Other|Questionnaires|Quality of life Depression Physical pain Social provisions Quality of sleep
15810446|NCT04363606|Biological|blood test|complete blood count and cytokine concentration, TNF-alpha, LDL oxidized, AOPP, SOD, GPX, catalase, albumin, transthyretin, RBP, transferin, α-1 glycoprotein acide, ferritine, selenium, zinc, magnesium
15810447|NCT04363606|Other|Maximal effort test|The maximal effort test with VO2max recordings will be assessed during the first visit to the laboratory.
15810448|NCT04363606|Device|actigraphy|assessment of sleep quality
15810449|NCT04363606|Device|Neuromuscular evaluation|"The maximum isometric force produced by the knee extensors will be measured on the ergometer
~the intensity of muscular electrical activity recorded by surface electromyography
~Peripheral nerve stimulation
~Transcranial magnetic stimulation
~Magnetic resonance imaging"
15810450|NCT04363606|Other|stool analysis|analyze the composition of the intestinal microbiote. concerns only the patients of Saint Etienne
15810451|NCT04363606|Other|food diary|3 days of information to determine nutrient intakes. concerns only the patients of Saint Etienne
15810452|NCT04363593|Biological|Serological test|Serological testing is performed for patients with confirmed COVID-19 infection by RT-PCR.
15810453|NCT04363593|Biological|Serum test|Use of the serum taken from patients consulted for suspicion of COVID-19 before the beginning of the trial
15810454|NCT04363580|Other|Auditory processing disorder screening tool|"Screening tool : a questionnaire completed by the parents and the child's teacher and a mini-battery of tests composed of verbal and nonverbal assessments.
~Questions for parents are grouped into four sections:
~Reference pattern and portrait of the child.
~Auditory history.
~History of speech and language development.
~School history.
~The teacher questionnaire has seven sections:
~Portrait of the child.
~Reading and writing.
~Speaking.
~Mathematics.
~Music.
~Memory.
~Listening skills and understanding:
~Concentration and organization.
~Environment.
~Mini-battery of tests:
~Dichotic Numeric Listening Test.
~Identification test of 15 patterns of frequency-varying sounds at each ear.
~Test of 10 monosyllables in noise per ear.
~Auditory memory test by measuring the range of figures (instead of words in order to reduce the contribution of language processing)."
15810455|NCT04363554|Other|Fluid intake|The participants will intake fluid
15810456|NCT04363554|Other|Thirsting|The participants will thirst
15810457|NCT04363541|Device|Electric pad for human external pain therapy|An electric pad for local heat production will be put on the back of the patient for two hours
15810458|NCT04363528|Other|Doppler Echo|2 doppler echo will be done at patients hospitalized in ICU and with SARS-CoV-2 pneumopathy at 7 days apart
15810459|NCT04363515|Behavioral|Social support network counseling intervention|Pilot social support counseling intervention for kidney transplant candidates along with their social support networks
15810460|NCT04363502|Drug|Clazakizumab|The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes.
15810461|NCT04363502|Drug|Placebo|The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes.
15810462|NCT04363489|Device|Wearable Medical Device (Empatica E4)|A wearable medical device (Empatica E4) which is a smart wristband that detects skin temperature, heart rate and sleep. It is CE and FDA approved.
15810463|NCT04363489|Diagnostic Test|COVID-19 PCR Swab|COVID-19 PCR Swab will be self-taken by doctors every day. Fischer nasopharyngeal PCR Swabs
15810464|NCT04363489|Diagnostic Test|Pulse Oximeter|Participants will measure their oxygen saturations every day, and report them on the survey. Pulmolink A310 pulse oximeters
15810465|NCT04363476|Other|SHRED Osteoarthritis program|Combined exercise and education intervention
15810466|NCT04363463|Other|prone position|Two sessions minimum of prone position over the day. With a total objective of at least 2h30 of cumulated duration over the day. The objective is to spend as much time as possible in prone position if the patient tolerates it well.
15810467|NCT04363450|Drug|Hydroxychloroquine|Hydroxychloroquine loading 400mg (2 capsules) twice 12 hours apart followed by 200mg (1 capsule) twice weekly
15810469|NCT04363437|Drug|Colchicine|People in the colchine group will be given a starting dose of 1.2 mg followed, by 0.6mg after 2 hours if they do not have significant gastrointestinal symptoms, on day 1. After that, they will take colchicine 0.6mg twice a day for 14 days or until discharged or release from the hospital.
15810470|NCT04363437|Drug|Usual Care|COVID Patients in this arm will receive usual care COVID19 treatment and will not receive colchine.
15810471|NCT04363411|Other|finger prick screening for BBV infections and questionnaires by outreaching methodology|Screening by fingerprick for HCV Ab, HBsAg and HIV Ab and a questionnaire will be performed at sites outside of the regular treatment facilities.
15810472|NCT04363398|Other|Comprehensive Follow-up|Trained research staff members will provide weekly support to coaches on the NMT warm-up.
15810473|NCT04363398|Other|Standard Follow-up|Research staff will monitor teams weekly, however no additional support for warm-up will be provided.
15810474|NCT04363385|Biological|Biological test|Blood sample
15810475|NCT04363372|Drug|MRx-4DP0004|MRx-4DP0004 is a lyophilised formulation of a proprietary strain of bacteria.
15810476|NCT04363372|Drug|Placebo|Placebo capsules will be identical in appearance to active product.
15810477|NCT04363359|Biological|0.5ml Quadrivalent influenza vaccine|The inactivated split virion vaccines contained 15 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2, B/Victoria and B/Yamagata strains
15810478|NCT04363359|Biological|0.25ml Quadrivalent influenza vaccine|The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2, B/Victoria and B/Yamagata strains
15810479|NCT04363359|Biological|0.25ml Trivalent influenza vaccine(B/V)|The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2 and B/Victoria strains
15810480|NCT04363359|Biological|0.25ml Trivalent influenza vaccine(B/Y)|The inactivated split virion vaccines contained 7.5 μg of each hemagglutinin antigen of influenza A/H1N1, A/H3N2 and B/Yamagata strains
15810481|NCT04363346|Drug|FT516|FT516 is an off-the-shelf cryopreserved NK cell product derived from an iPSC that was transduced with a high affinity, ADAM17 non-cleavable CD16 (Fc receptor) that maintains CD16 on the cell surface, which remains fully functional after NK cell activation.
15810482|NCT04363333|Diagnostic Test|Home Sleep Apnea Testing or In-hospital Polysomnography|Home Sleep Apnea Testing or In-hospital Polysomnography will be conducted 4 to 6 months after the Covid-19 diagnosis
15810483|NCT04363320|Behavioral|NIATx Coaching|NIATx framework provides each participating site with a NIATx Coach who is an expert in MOUD implementation and organizational change and will help the organization adopt, implement, and increase the use of MOUD. Coaches help the sites think through key issues, offer process improvement training, and suggest changes.
15810484|NCT04363320|Behavioral|ECHO|The ECHO model connects MOUD prescribers and experts with primary care providers and medical teams to promote high-quality MOUD practices. ECHO is provided monthly through videoconferences. Experienced MOUD prescribers address topics such as counseling strategies, urine test interpretation, and transitioning from buprenorphine, naltrexone and methadone.
15810485|NCT04363307|Device|AF Ablation|Adult participants undergoing standard of care AF ablation using VISITAG SURPOINT
15810486|NCT04363307|Device|MRI|Adult participants will undergo a late gadolinium enhancement MRI of the left atrium three months post standard of care ablation
15810487|NCT04363294|Diagnostic Test|PYP scan|99mTc-labeled pyrophosphate
15810488|NCT04363281|Other|preoperative questionnaire|"Three questions to predict acute pain:
~Verbal numeric score Anxiety 0-10
~Anticipated postoperative pain level
~Anticipated analgesic requirements
~Speilberger STATE-TRATE inventory index
~Pain Catastrophizing Scale"
15810489|NCT04363281|Other|PACU questionnaire|parturients will be approached and requested to fill out a questionnaire regarding intraoperative pain, medication consumption, anxiety and nausea.
15810490|NCT04363281|Other|Postoperative questionnaire|Parturients will be approached at 24 hours postpartum and questioned regarding anxiety levels and medication consumption and requested to fill out the OBSQOR 11 questionnaire at 24 hours postpartum.
15810491|NCT04363281|Other|Postoperative questionnaire- Obstetrician|The attended obstetrician will be questioned regarding the parturient's level of intraoperative pain, postoperative pain levels anxiety medication consumption, uteronic management, surgical technique and management.
15810492|NCT04363281|Other|Postoperative questionnaire- anesthesiologist|he attended anesthesiologist will be questioned regarding the parturient's level of intraoperative pain, postoperative pain levels anxiety medication consumption, uteronic management, surgical technique and management.
15810493|NCT04363255|Drug|Etoposide Injection|Etoposide(100mg/m2, d1-3, q3w) combined with platinum was the first-line chemotherapy in 4-6 cycles, and then JS001 combined with anlotinib as maintenance therapy were followed.
15810494|NCT04363255|Drug|Carboplatin Injection|Carboplatin(AUC 5, d1, q3w) or Cisplatin combined with etoposide was the first-line chemotherapy in 4-6 cycles, and then JS001 combined with anlotinib as maintenance therapy were followed.
15810495|NCT04363255|Drug|Cisplatin injection|Cisplatin(75mg/m2, d1, q3w) or carboplatin combined with etoposide was the first-line chemotherapy in 4-6 cycles, and then JS001 combined with anlotinib as maintenance therapy were followed.
15810496|NCT04363255|Drug|Toripalimab|After 4-6 cycles of chemotherapy, JS001(240mg, d1, q3w) combined with anlotinib were followed and continued until disease progression.
15810497|NCT04363255|Drug|Anlotinib hydrochloride|After 4-6 cycles of chemotherapy, anlotinib(12mg qd, d1-14, q3w) combined with JS001 were followed and continued until disease progression.
15810498|NCT04363242|Biological|SYN125|Administered by IV infusion
15810499|NCT04363242|Biological|SYN004|Administered by IV infusion
15810500|NCT04363229|Other|maslach burnout inventory questionnair|The Maslach Burnout Inventory (MBI) is an introspective psychological inventory consisting of 22 items pertaining to occupational burnout
15810501|NCT04363216|Drug|Ascorbic Acid|Ascor® ascorbic acid 2-hour infusion daily (for 6 days), escalating dose (0.3g/kg, 0.6g/kg, 0.9g/kg).
15810502|NCT04363203|Drug|Hydroxychloroquine|Hydroxychloroquine: 2x200mg mg .PO in the AM and 2x200mg PO in the PM on Day 1, followed by 200mg PO in the AM and 200 mg PO in the PM on Days 2-5.
15810503|NCT04363203|Drug|Azithromycin|Azithromycin: 2x250mg by mouth (PO) in the AM on Day 1, followed by 250mg PO every day on Days 2-5.
15810504|NCT04363203|Drug|Placebo oral tablet|Placebo in pill packs identical to study drugs
15810505|NCT04363190|Diagnostic Test|Cytogenetic analysis|"FISH study using the UroVysion kit in interphase peripheral lymphocytes, that allows the study of numerical aberrations for chromosomes 3, 7 and 17 and locus 9p21.
~G banding study to analyse the whole karyotype study regarding both numerical and structural aberrations during metaphase.
~Sister chromatid exchanges (SCE) analysis with bromodeoxyuridine (BrdU) staining for the whole karyotype during metaphase: analizing the proportion of SCE per metaphase (NSM)."
15810506|NCT04363177|Behavioral|Web-based psychosocial peer-to-peer support|"The evidence-based eHealth peer-to-peer psychosocial intervention Thinking Healthy, will be tested in this RCT. In line with the World Health Organization's mhGAP Intervention Guide (mhGAP-IG), Thinking Healthy is used to identify and manage perinatal mental health conditions (distress, symptoms of depression, and anxiety) in non-specialized psychosocial support setting."
15810507|NCT04363164|Drug|Testosterone cypionate|Depo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. Depo-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
15810508|NCT04363164|Drug|Enzalutamide|Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water. Enzalutamide is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide.
15810509|NCT04363164|Drug|Testosterone enanthate|Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative.
15810510|NCT04363151|Other|No intervention.|
15810511|NCT04363125|Diagnostic Test|Pathology result|Pathology result of rectal biopsy
15810512|NCT04363112|Behavioral|Mini Kid II|Mini Kid II (Mini International Neuropsychiatric Interview ) is a standardised, hetero mental health questionary for children, according to DSM IV. Mini Kid II will be administered to children between day 3 and 7 during the study.
15810513|NCT04363099|Other|observational|observational management of outpatients COVID 19
15810514|NCT04363086|Behavioral|iFightDepression online self-help tool|Computerized cognitive behavior therapy
15810515|NCT04363086|Behavioral|Treatment as Usual|TAU
15810516|NCT04363086|Behavioral|phone call|phone call
15810517|NCT04363073|Device|Annabella Breast Pump|Milk will be expressed using Annabella breast pump for 4 consecutive days (at least 24h apart)
15810518|NCT04363073|Device|Control Breast Pump|Milk will be expressed using Control breast pump for 4 consecutive days (at least 24h apart)
15810519|NCT04363060|Combination Product|Azithromycin with amoxicillin/clavulanate|Patients will receive azithromycin 500 mg on day 1 followed by 250mg per day for the next four days with amoxicillin/clavulanate 1 gr 3 times per day during 7 days. In case of allergy, amoxicillin/clavulanate can be replaced by a third-generation cephalosporin
15810520|NCT04363060|Drug|amoxicillin/clavulanate|Patients will receive amoxicillin/clavulanate 1 gr 3 times per day during 7 days. In case of allergy, amoxicillin/clavulanate can be replaced by a third-generation cephalosporin
15810521|NCT04363047|Other|40ml blood sample|We'll be collecting cells, DNA and serum.
15810522|NCT04363034|Biological|Convalescent Plasma|1-2 units (200-400 mL per unit, not to exceed 550 mL total) of ABO compatible, low isohemagglutinin titer, COVID-19 convalescent plasma
15810523|NCT04363008|Diagnostic Test|serum inflammatory biomarkers|Serum biomarkers measured (IL-1 beta, IL-2, IL-6, IL-10, TNF alpha)
15810524|NCT04362982|Other|ADHD360 platform: An intervention intergrating a serious game along with a mobile application for daily behavioral monitoring.|Clinical trials will include two parts. The first part includes three visits. In the first visit, children and their parents will come to the Laboratory of Medical Physics to be informed regarding the experimental procedures, sign the consent form and familiarize with the scientific staff involved in the project as well as the lab enviroment. In the second visit, children will undergo an neuropsychological assessment delivered by an experienced pscychologist. Afterwards, they will interact with the ADHD360 platfrom for 30-45 minutes. In the third visit, participants will interact with the ADHD360 platfrom for 30-45 minutes. In the second part, participants will use the ADHD360 platfrom two or three times per week for about 30-45 minutes. At the end of the second part, participants will undergo a neuropsychological evalutation following the same procedures as the first one.
15810525|NCT04362943|Drug|Baricitinib or Anakinra|Treatment with either Baricitinib or Anakinra during hospitalization, in real world, and under usual clinical care.
15810526|NCT04362917|Other|There is no intervention|There is no intervention
15810527|NCT04362904|Other|acupressure|
15810528|NCT04362891|Procedure|Cosmetic lip augmentation|The primary study treatment site will be the vermilion (body of the lip); additional areas (vermilion borders, Cupid's bow, philtral columns, and/or oral commissures) will be treated if deemed appropriate by the treating physician. Treatment will be administered through intradermal, subdermal, and/or intramuscular injection within the orbicularis oris muscle. Injection techniques for each area will include linear threading, serial puncture, fanning, and/or cross-hatching. The treating physician will determine the appropriate volume to inject based on clinical experience and the subject's goals for lip augmentation.
15810529|NCT04362839|Biological|Ipilimumab|Given IV
15810530|NCT04362839|Biological|Nivolumab|Given IV
15810531|NCT04362839|Drug|Regorafenib|Given PO
15810532|NCT04362826|Biological|Novel probiotic|Investigational novel probiotic
15810533|NCT04362826|Other|Placebo|Placebo for probiotic
15810534|NCT04362813|Drug|Canakinumab|Canakinumab 450 mg for body weight 40-<60 kg, 600 mg for 60-80 kg or 750 mg for >80 kg in 250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
15810535|NCT04362813|Drug|Placebo|250 mL of 5% dextrose infused IV over 2 hours. Single dose on Day 1.
15810536|NCT04362800|Other|MRI|MRI at baseline and J90
15810537|NCT04362800|Other|Electro-Encephalography-High Density|Electro-Encephalography-High Density (children with unilateral PC only) at baseline and J90
15810539|NCT04362800|Other|care and classic activities|physiotherapy and psychomotility. As needed weekly sessions of speech therapist or orthoptist and daily activities of the child.
15810540|NCT04362787|Device|High pressure non invasive ventilation in acute hypercapnic respiratory failure|Usage of High pressure non invasive ventilation in acute hypercapnic respiratory failure
15810541|NCT04362774|Device|ORBERA365|Behavioral modification program in conjunction with endoscopic placement of a single ORBERA365 Intragastric Balloon, filled with saline to an inflation volume between 400cc and 700cc with 2mL of Methylene blue (10mg/mL)
15810542|NCT04362761|Drug|ELX/TEZ/IVA|Fixed-dose combination (FDC) tablet for oral administration.
15810543|NCT04362761|Drug|IVA|Mono tablet for oral administration.
15810544|NCT04362748|Drug|AMG 256|AMG 256 administered as an intravenous (IV) infusion.
15810545|NCT04362735|Drug|Vedolizumab|Vedolizumab 300 mg at weeks 0, 2 and 6 as induction. Maintenance every 4 or 8 weeks, as on-label recommendations.
15810546|NCT04362722|Drug|L19IL2 +L19TNF|Single or multiple intratumoral administration of a mixture of L19IL2 and L19TNF will be performed once weekly for up to 4 weeks into all injectable lesions present at the beginning of treatment or appearing during treatment phase The dose will be constituted by 6.5 Mio IU L19IL2 (~1.08 mg) and 200 µg L19TNF.
15810547|NCT04362696|Device|High definition transcranial electrical current stimulation|Low-intensity and safe, noninvasive application of electrical current to the human scalp with the goal of gradually modulating levels of neuronal excitability.
15810548|NCT04362670|Drug|OTX-CSI|OTX-CSI intracanalicular insert
15810549|NCT04362670|Other|Placebo Vehicle|Hydrogel Vehicle intracanalicular insert
15810550|NCT04362657|Diagnostic Test|Computer Aided Diagnosis|Computer Aided diagnosis is an environment-enhancing technology developed to aid humans to improve their accuracy, speed and confidence by providing live feedback during the procedure, on request, or after the procedure has been completed.
15810551|NCT04362644|Drug|PET/CT using PET ligands [F-18]FDG and [F-18]DPA-714|Study participants will undergo PET/CT with the glucose analogue [F-18]FDG and the TSPO ligand [F-18]DPA-714 in two separate imaging sessions.
15810552|NCT04362618|Other|Muscle Strengthening Training|Muscle strengthening training will take place for a period of 12 weeks, in which participants will have 36 exercise sessions (18 at the hospital under supervision of a physiotherapist; 18 unsupervised at home) planned. Muscles of the leg (i.e. quadriceps, hip ab- and adductors) will be trained at 3 set of 10 repetitions at 80% of 1RM with the use of elastic bands. 1RM will be assessed at baseline and the exercise intensity will be progressively increased by 10% of 1RM every two sessions from 50 up to 70-80 % of 1RM. Every 6 sessions, the 1RM will be reassessed and the training resistances will be adapted.
15810553|NCT04362618|Behavioral|Behavioral graded activity|Subjects will receive a behavioural treatment integrated within the concepts of operant conditioning with exercise therapy for a period of 12 weeks, in which the subjects will have maximum 36 BGA sessions (min. 13- max. 18 at the hospital under supervision of a physiotherapist; 18 unsupervised at home) planned. The purpose of BGA is to increase the level of activities in a time-contingent manner and increase the level of physical activity in the subject's daily lives. BGA consists of 3 phases: pain education (phase 1), treatment phase in which subjects increase their level of activity gradually (phase 2) and integration of learned principles in daily live (phase 3).
15810554|NCT04362605|Procedure|Endoscopic Negative Pressure Therapy|"In patients with suspected insufficiency of the esophagojejunostomy first an index endoscopy under general anesthesia with endotracheal intubation was indicated. Standard gastroscopes with outer diameter of 9.8mm were used with carbon dioxide insufflation.
~Definition of a anastomotic leak were endoscopic or radiological dehiscences at the esophagojejunostomy with extravasation of fluids and gas. In cases of insufficiencies start of endoluminal ENPT were indicated.
~Decision criteria for placement of OPD or OFD were the defect size, radiological findings and clinical situation of the patient. A CT scan in patients with suspected EJAL was done in all cases.
~For endoluminal ENPT, the open-pore drainage system is placed within the lumen of the digestive tract at the entrance to the cavity."
15810555|NCT04362592|Device|In Utero Endoscopic Correction of Myelomeningocele IDE - Percutaneous Technique|The percutaneous approach uses endoscopes through a closed maternal abdomen and closed uterus to perform the spina bifida correction.
15810556|NCT04362592|Device|In Utero Endoscopic Correction of Myelomeningocele IDE - Laparotomy/Uterine Exteriorization Technique|The laparotomy/uterine exteriorization technique uses endoscopes through an open abdomen and closed, exteriorized uterus to perform the spina bifida correction.
15810557|NCT04362579|Device|wearable vital signs sensor|vital signs monitoring during maternal non-stress testing or in the home setting
15810560|NCT04362553|Device|wearable vital signs sensor|vital signs monitoring during standard of care procedures; TTE, swan-ganz catheterization
15810726|NCT04361136|Drug|Delgocitinib cream vehicle|The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
15810561|NCT04362540|Diagnostic Test|MRI scan|On attendance to antenatal clinic with confirmed diagnosis of gestational diabetes based on OGTT and following informed consent: Ultrasound scan: Those with positive OGTT results (i.e. GDM positive) will attend an appointment for an ultrasound scan, as per routine practice. These women will,at that appointment, be assessed for presence/absence of NAFLD as well as undergoing their routine foetal assessment. This is a simple addendum to the existing scan, taking no more than 5 minutes. Participants will have been informed during the consent process that the results (regarding the presence / absence of NAFLD) will be compared to MRI after delivery.
15810562|NCT04362527|Drug|Milrinone 1 Mg/mL Solution for Injection|Blinding procedure will be set up for the administration of the treatment
15810563|NCT04362527|Drug|Saline solution for injection|Blinding procedure will be set up for the administration of the treatment
15810564|NCT04362514|Behavioral|MEPC - Multi-component exercise program related to cycling|Structured and progressive multicomponent exercise program with and without bikes. Training period will last over 3 months with 8 sessions à 60 minutes. Training sessions will address motor competence (balance, strength, cycling skills and techniques) and cognitive skills required during cycling. Furthermore, fall-related psychological concerns will be addressed.
15810565|NCT04362514|Other|HRP - health-related presentations|HRP include 3 presentations on healthy aging (one per month) with a duration of 60 minutes
15810566|NCT04362501|Biological|dupilumab|300mg dupixent SC every two weeks for six months
15810567|NCT04362501|Drug|placebo|placebo SC injection every two weeks for six months
15810568|NCT04362488|Procedure|Preoperative evaluation|"Preoperative evaluation using differents clinical evaluation tests, questionnaires, and instrument:
~Delos system (computerized oscillating platform)
~Foot and Ankle Ability Measure (FAAM), l'American Orthopaedic Foot and Ankle Score (AOFAs), SF12 questionnaires
~modified Star Excursional Balance Test (mSEBT) and Short Physical Performance Battery (SPPB)"
15810569|NCT04362488|Procedure|Postoperative evaluation|"Postoperative evaluation at 4 months of follow up after surgery using differents clinical evaluation tests, questionnaires, and instrument:
~Delos system (computerized oscillating platform)
~Foot and Ankle Ability Measure (FAAM), l'American Orthopaedic Foot and Ankle Score (AOFAs), SF12 questionnaires
~modified Star Excursional Balance Test (mSEBT) and Short Physical Performance Battery (SPPB)"
15810570|NCT04362475|Behavioral|Community Health through Engagement and Environmental Renewal (CHEER)|FYI and ESPI intervention activities will be implemented in the overall study, CHEER. It will also allow us to examine possible synergistic effects of both interventions when implemented in the same neighborhoods. Separate sets of participants will be selected for the FYI comparisons and for the ESPI comparisons. Because the FYI intervention focuses on mothers and their children, participants for the FYI comparisons will be selected by Respondent Driven Sampling of eligible families from the neighborhoods in all four cells. The ESPI intervention targets the whole neighborhood, and thus a random sample of neighborhood residents will be enrolled in each of the four cells. Because the primary outcomes for FYI and ESPI are connected but differ from each other, the FYI samples will be assessed for the FYI outcomes in all four cells and the ESPI samples will be assessed for the ESPI outcomes in all four cells.
15810571|NCT04362449|Combination Product|Shortened hydration time and dispensary of Akynzeo|Hydration is reduced to 1 hour and 40 minutes and Akynzeo is administered as an oral drug instead of Ondansetron being given as an IV before chemotherapy.
15810572|NCT04362449|Combination Product|Standard of care|Hydration remains at around 6 hours and 30 minutes due to no oral fluids being consumed prior to treatment and normal saline being administered for 90 minutes before cisplatin and then for 2 hours after cisplatin and before gemcitabine administration
15810573|NCT04362436|Radiation|TheraSpheres Selective Internal Radiation Therapy (SIRT)|Single-photon emission computed tomography (SPECT) imaging will assess 99mTc-MAA (MAA being macro aggregated albumin) deposition in the tumour bed to estimate the dose of radiation to tumour and healthy tissue, before administration of TheraSpheres to eligible patients
15810574|NCT04362423|Device|fNIRS|Near infrared spectroscopy (NIRS) is a non-invasive, portable, relatively inexpensive optical technology similar to pulse oximetry except that it measures total hemoglobin, oxy-hemoglobin, and deoxyhemoglobin in brain tissue (capillaries) rather than arteries.
15810575|NCT04362410|Biological|Experimental: Tezepelumab|Tezepelumab single dose subcutaneously injection.
15810576|NCT04362410|Other|Placebo|Placebo single dose subcutaneously injection.
15810577|NCT04362397|Behavioral|FoCo|This is an attention, care and self-care training.
15810578|NCT04362397|Behavioral|No intervention|This is a waiting list
15810579|NCT04362384|Drug|Vitamin E ovules|Endoanal vitamin E ovules will be prescribed
15810580|NCT04362384|Drug|Prednisolone ointment|Endoanal Prednisolone ointment will be prescribed
15810581|NCT04362371|Device|Ainara|1 g at each administration
15810582|NCT04362358|Behavioral|Online cognitive behavioral therapy (CBT)|7 sessions of Cognitive Behavioural Therapy (CBT) online + possibility to contact the psychological hotline
15810583|NCT04362358|Behavioral|Online bibliotherapy programme|online bibliotherapy programme on the Ma Santé website Also with explanatory sheets and tools to improve stress management and the possibility of contacting the Psychological Hotline
15810584|NCT04362332|Drug|Chloroquine Sulfate|cluster randomized
15810585|NCT04362332|Drug|Hydroxychloroquine|cluster randomized
15810586|NCT04362332|Other|Standard supportive care|cluster randomized
15810587|NCT04362319|Diagnostic Test|Questionnaire forms|Assessment of demographics, burnout, depression and self-perceived medical errors
15810588|NCT04362306|Behavioral|Planned Intervention|Intervention with a member of the medical physics team to review the process of simulation, treatment planning, and subsequent treatment. This meeting will last approximately 15 minutes and at this time, the team member will explain that they are the primary resource for all the technical aspects related to the patient's treatment. Additionally, they will identify and address any concerns that patients or their caregivers have with radiation treatment and the patient will be shown the simulation infographic.
15810589|NCT04362306|Behavioral|No planned intervention|Anxiety and patient satisfaction questionnaires will be completed prior to CT simulation.
15810650|NCT04361721|Drug|Erenumab|First injection of erenumab 70 mg subcutaneously was administered in hospital. The second injection of erenumab 70 mg was administered in hospital after 28 days, while the third and last dose of erenumab 70 mg was self-administered at home by the patients themselves after an additional 28-day interval.
15810590|NCT04362293|Drug|hydroxyurea, azathioprine, alemtuzumab, thioptepa, low dose total body irradiation and sirolimus|"The conditioning regimen will consist of hydroxyurea (30mg/Kg) and azathioprine (3mg/Kg) by mouth daily from day -60 to day -8, alemtuzumab subcutaneously daily for 5 days (0.03mg/kg on Day -7, 0.1mg/kg on Day -6, 0.3mg/kg on days -5 to -3), thiotepa intravenously (10mg/Kg) on day -3 and low dose total body irradiation (TBI) 200 cGY on day -2 with gonadal shielding (if possible). The HSCT graft will be G-CSF mobilized PBSCs with minimum CD34+ of 5 x10^6/kg recipient weight.
~GVHD prophylaxis will be sirolimus with a loading dose 3 mg/m2 on day -1. Sirolimus dose will be adjusted to maintain a target trough level 5-15 ng/mL. Low dose donor lymphocyte infusions will begin on day +28 and continue till donor lymphocyte chimerism reaches at least 90% donor."
15810591|NCT04362293|Drug|hydroxyurea, azathioprine, alemtuzumab, thiotepa, plerixafor, low dose total body irradiation, cyclophosphamide and sirolimus|"The conditioning regimen will consist of hydroxyurea (30mg/Kg) and azathioprine (3mg/Kg) by mouth daily from day -60 to day -8, alemtuzumab subcutaneously daily for 5 days (0.03mg/kg on Day -7, 0.1mg/kg on Day -6, 0.3mg/kg on days -5 to -3), thiotepa intravenously (10mg/Kg) on day -3, plerixafor (0.24mg/Kg) subcutaneously every 12 hours on days -3 and -2 and low dose total body irradiation (TBI) 200 cGY on days -2 and -1 with gonadal shielding (if possible). The HSCT graft will be G-CSF mobilized PBSCs with minimum CD34+ of 5 x10^6/kg recipient weight.
~GVHD prophylaxis will be cyclophosphamide (50mg/Kg) intravenously on days +3 and +4 and sirolimus with a loading dose 3 mg/m2 starting on day +5. Sirolimus dose will be adjusted to maintain a target trough level 5-15 ng/mL. Low dose donor lymphocyte infusions will begin on day +28 and continue till donor lymphocyte chimerism reaches at least 90% donor."
15810592|NCT04362280|Behavioral|ReCHARGE|During their PE class, all participants (both arms) participate in an intensive lifestyle intervention with established efficacy among this population for the academic fall semester. The following semester, participants are randomized to different treatment arms. ReCHARGE increases the intensity of treatment provided in the first semester by increasing social support and addressing common barriers youth have to adhering to intervention.
15810593|NCT04362280|Behavioral|TAU|PE class as usual led by PE teacher.
15810594|NCT04362267|Other|self-administered questionnaire|Every14 days, clinical and occupational questionnaire are performed among a cohort of HCW exposed to covid occupational exposure
15810595|NCT04362267|Diagnostic Test|SARS-Cov2 testing|Every14 days, SARS-Cov2 RT-PCR, serological testing are performed among a cohort of HCW exposed to covid occupational exposure
15810597|NCT04362241|Drug|Prednisolone Acetate 1% Ophthalmic Suspension [PRED FORTE]|Prednisolone Acetate 1% ophthalmic drops
15810598|NCT04362228|Behavioral|Whole-body exercise|12-week whole-body exercise class, 3x/week, focused on increasing respiratory rate through moderate-intensity aerobic exercises.
15810599|NCT04362215|Diagnostic Test|Subjective accomodation amplitude measurement|ECG:Electrocardıography Echocardiography, Holter implementation(for Lf/Hf ratio))
15810600|NCT04362202|Other|Water-based Sequential Preparatory Approach|"The experimental training consists of a sequential and a preparatory approach aimed at enhancing dynamic postural stability. The exercises followed a specific sequence starting from a kneeling position, proceeding to a sitting position and ending with a supine position. Step exercises preparatory for gait were performed using a step and two floating aids. Gait exercises were performed first with the upper limbs placed on two floating aids and then during a dual motor task (i.e., catching a ball thrown by the therapist).
~The control aquatic therapy consists of water-based exercises, in line with suggestions of the Hydrotherapy Association of Chartered Physiotherapists Guidance on Good Practice in Hydrotherapy.
~These consisted of warm-up exercises, stretching exercises for the lower limbs, recruitment exercises and walking exercises during each phase of gait (single stance, swing and double stance)."
15810601|NCT04362189|Biological|HB-adMSC|Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
15810602|NCT04362189|Other|Placebo|Saline
15810603|NCT04362176|Biological|pathogen reduced SARS-CoV-2 convalescent plasma|Convalescent COVID-19 donor plasma is the liquid part of blood that is collected from patients who have recovered from COVID-19 infection. This plasma contains SARS-CoV-2 specific antibodies that may help fight the infection.
15810604|NCT04362176|Biological|Placebo|Lactated Ringer's solution with multivitamins
15810605|NCT04362163|Device|Snorkel-based improvised personal protective equipment|An improvised PPE design based on a full face snorkel mask mated to a heat-and-moisture exchange filter via a 3D printed adaptor.
15810606|NCT04362137|Drug|Ruxolitinib|Ruxolitinib 5 mg tablets
15810607|NCT04362137|Drug|Placebo|Matching-image placebo
15810608|NCT04362124|Biological|vaccine BCG|Performance evaluation of a single dose of BCG vaccine in reducing the severity of SARS-COV-2 infection compared to placebo, in healthcare personnel.
15810609|NCT04362124|Other|Placebo|A single dose intradermal application of normal saline solution.
15810610|NCT04362111|Drug|Anakinra|The active treatment group will receive anakinra 100 mg subcutaneously every 6-12 hours for a period of 10 days
15810611|NCT04362111|Drug|Normal saline|The control group will receive normal saline placebo subcutaneously every 6-12 hours for period of 10 days
15810612|NCT04362098|Behavioral|Home visiting Program for Young Pregnant Women|The visitation program was elaborated based in the following theoretical principles: a) Albert Bandura's self-efficacy theory; b) Urie Brofenbrenner's bioecological theory, which recognizes the importance of the insertion of individuals in families in varied contexts of life in society; c) John Bowlby and Mary Ainsworth's attachment theory. The basic premises of the intervention are health care, environmental health, life course development, development of parenting ability, relationship with friends and family, and social service support.
15810614|NCT04362072|Drug|Lorlatinib|25 milligram (mg) tablet
15810615|NCT04362059|Device|COVSurf Drug Delivery System|Device introduces surfactant to the patients lungs
15810616|NCT04362059|Other|Standard of Care|Standard of care treatment for respiratory illness
15810724|NCT04361149|Other|Placebo Cream|Placebo cream will be administered as a topical skin cream
15810725|NCT04361136|Drug|Delgocitinib cream|Cream for topical application
15810618|NCT04362033|Diagnostic Test|Passive Leg Raising (PLR) and PEEP increment (PEEP)|PLR: Fluid responsiveness maneuver which patient is positioned from 45 grade of semi-recumbent position to dorsal decubitus and the legs are raised at 45 grades; PEEP increment: Fluid responsiveness maneuver which consisted in increased the PEEP level 5 cmH2O above the mean airway pressure, patient is positioned in 45 grade of semi-recumbent position
15810619|NCT04362020|Other|Distal radial access|Distal radial access and No anticoagulation
15810620|NCT04362020|Other|Distal radial access|Distal radial access and ACT-guided anticoagulation
15810621|NCT04362007|Drug|ASTX660|Treatment of ASTX660 for r/r PTCL and r/r CTCL
15810622|NCT04362007|Drug|ASTX660|Treatment of ASTX660 for r/r ATLL
15810623|NCT04362007|Drug|ASTX660|Treatment of ASTX660 for r/r PTCL
15810624|NCT04361981|Other|Deep Venous Disease Diagnostic|Clinical and/or echographic diagnosis of Deep Venous Disease in a patient with COVID-19 infection
15810625|NCT04361968|Other|Animal-assisted placebo condition|Participants receive the same verbal information as in the Placebo condition. Additionally, participants will receive the same verbal information as in the Dog only condition.
15810626|NCT04361968|Other|Placebo condition|"Participants receive verbal information that they are receiving an analgesic cream (i.e. Antidolor, containing Lidocain), which has been shown to produce significant pain reduction in previous clinical trials. However, they will receive an inert cream."
15810627|NCT04361968|Other|Dog only condition|"Participants will get a therapeutic rationale for the presence of the dog. The rationale is supported in the literature and therefore not invented for the purpose of this study. Participants will be told that: Studies have shown the presence of an animal can affect pain perception because the presence and the interaction with an animal can increase our Oxytocin level. Therefore, the investigators want to examine if the presence of a dog has an impact on your pain perception. While participants have to wait for the action time of the cream they are allowed to pet the dog. The intensity of interaction will be documented and be rated on a scale from 1-5 (1=very low degree of interaction, 5=very high degree of interaction). During the experiment the dog will be lying in the room with some distance to participants to avoid further physical interaction. The dog will always be lying at the same spot. Participants will still be able to see the dog."
15810628|NCT04361968|Other|Control Condition|Participants in this condition will receive no intervention. All instructions will be conveyed in a standardized manner to ensure that the participant-experimenter relationship is comparable in terms of friendliness and attention across all four conditions.
15810629|NCT04361955|Other|EMG|recordings of muscle electrical activity during nerve stimulation using EMG
15810630|NCT04361955|Other|EEG|recordings of brain activity using EEG
15810631|NCT04361942|Biological|Mesenchymal Stromal Cells|Intravenous injection of 1 million MSV cells/Kg diluted in 100 ml saline
15810632|NCT04361942|Other|Placebo|Intravenous injection of 100 ml saline containing no cells
15810633|NCT04361929|Device|Ultrasound|The following ultrasound measurements will be assessed: DS-HB, HMDR, TT, TT-S, TW, EW, ET, DS-E, and DS-V.
15810634|NCT04361916|Other|home care monitoring|home care active monitoring of patients with suspected of confirmed COVID-19
15810635|NCT04361903|Drug|Ruxolitinib Oral Tablet|Ruxolitinib Oral Tablet dosage of at least 20 mg x 2 / day in the first 48 hours
15810636|NCT04361890|Diagnostic Test|perineal ultrasound|all women will have ultrasound measurements of the bladder neck descent, of the movement of the ano-rectal angle during a Valsalva maneuver and elastographic measurement before and after PFMT. All measurement will be conducted by perineal route, with is a non invasive ultrasound route
15810637|NCT04361851|Drug|Pembrolizumab|Experimental
15810638|NCT04361838|Behavioral|prayer|receive prayers daily while in ICU
15810639|NCT04361825|Drug|Durvalumab|Durvalumab 1500mg via IV administered for every 4weeks(fixed dosing for subjects > 30 kg body weight) in Day 1 of each cycle and AZD 6738 240mg bid per os administered in each cycle days 15 and 28. One cycle is consisted of 28 days.
15810640|NCT04361812|Drug|HS632|Subcutaneous injection of HS632
15810641|NCT04361812|Drug|Omalizumab (Xolair®)|Subcutaneous injection of Omalizumab Xolair®)
15810642|NCT04361799|Device|CamAPS|Fully automated closed-loop subcutaneous insulin delivery system. A model predictive controller modulates insulin delivery every 10-12 minutes based on interstitial glucose measurements.
15810643|NCT04361799|Drug|Standard insulin therapy|Standard insulin therapy according to local clinical practice.
15810644|NCT04361773|Radiation|Photobiomodulation|Treatment with a device with 144 light emitting diodes (LEDs) at wavelengths of 420, 660 and 850nm, 3J per point for 10 minutes.
15810645|NCT04361773|Other|Sham Photobiomodulation|Simulation of the LED application, with a device with external characteristics identical to that of the PBM group, for the same period of time.
15810646|NCT04361760|Device|single-puls TMS|Medical Device (MD): MagPro X100
15810647|NCT04361760|Device|sham stimulation|Sham stimulation is delivered with a dedicated coil, which is magnetically shielded and thus produces only approx. 20% of the nominal magnetic field. This is not enough to reach and stimulate the cortex, but the produced sound and scalp sensation are the same as with a real TMS coil.
15810648|NCT04361747|Behavioral|nursing counseling|The counseling intervention was designed to facilitate self-awareness, reduce self-blame, clarify doubts, listen to patient concerns, promote forward thinking, and encourage life planning.
15810649|NCT04361734|Other|Blood sampling to include Deoxyribonucleic Acid (DNA) and Ribonucleic Acid (RNA)|"Blood sampling to measure immune cell phenotypes and examine DNA/RNA and identify serum biomarkers.
~Food Frequency Questionnaires (FFQs) and/or diet recall questionnaires to assess dietary intake.
~Cardiovascular Ultrasound Scans (USS) to measure how well blood is carried around the body."
15810651|NCT04361708|Drug|Oxaliplatin|Oxaliplatin will be administered on day 1 of each cycle at 85mg/kg. The drugs will be given through the patient's Mediport. It will be given once every 14 days (2 weeks), on days 1 and will be continued for 8 doses (4 months)
15810652|NCT04361708|Drug|Docetaxel|Docetaxel will be administered on day 1 of each cycle at 25mg at dose level 1; 37.5 at dose level 2. The drugs will be given through the patient's Mediport.It will be given once every 14 days (2 weeks), on days 1 and will be continued for 8 doses (4 months)
15810653|NCT04361708|Drug|Leucovorin|Leucovorin will be administered on day 1 of each cycle at 400mg/kg. The drugs will be given through the patient's Mediport. It will be given once every 14 days (2 weeks), on days 1 and will be continued for 8 doses (4 months)
15810654|NCT04361708|Drug|Irinotecan|Irinotecan will be administered on day 1 of each cycle at 120mg/m2 for low risk group, 105mg/m2 for intermediate risk group, 45mg/m2 for high risk group . The drugs will be given through the patient's Mediport. It will be given once every 14 days (2 weeks), on days 1 and will be continued for 8 doses (4 months)
15810655|NCT04361708|Drug|5-Fluorouracil|5-FU is given as a continuous intravenous infusion over 2 days. Patient can receive the 2-day infusion as an outpatient. On day 3 of each cycle, the patient will return to the infusion center to have the infusion hook-up disconnected.
15810656|NCT04361695|Procedure|Hemorrhoidectomy|The patient receives spinal anaesthesia and is placed in lithotomy position. A complex of external and internal haemorrhoid or internal haemorrhoid only is excised with monopolar electrocautery or bipolar electrosurgery device. Haemorrhoid pedicle is tied with absorbable polyfilament suture. One, two or three nodes can be removed per a procedure.
15810657|NCT04361695|Drug|Ketoprophenum|Ketoprophenum
15810658|NCT04361695|Drug|Placebo|Placebo
15810659|NCT04361682|Procedure|Surgical Drain Management|
15810660|NCT04361669|Other|Medication safety review|Implementation of a medication safety review using a clinical decision support system
15810661|NCT04361656|Drug|PEG-ELS current standard of care|Standard of care for inpatient colonoscopy
15810662|NCT04361656|Drug|PEG-ELS current standard of care plus Lubiprostone 24 microgram Oral Cap (x2)|The dose of Lubiprostone will be 24 mcg capsule orally (roughly every 12 hours) for total of 2 doses, with the last dose being at least 4 hours prior to the scheduled colonoscopy if it is BEFORE 11 a.m., and Lubiprostone 24 mcg capsule orally 2 hours before each dose of the PEG-ELS if colonoscopy is scheduled AT or AFTER 11 a.m..
15810663|NCT04361643|Drug|Lenalidomide as a 5 mg capsule PO daily, days 1, 3, and 5.|Patients will receive Lenalidomide as a 5 mg capsule PO daily, days 1, 3 and 5, together with a prophylactic dose of low molecular weight heparin (LMWH) or therapeutic dose if needed due to previous comorbidity.
15810664|NCT04361643|Drug|Placebo|Patients will receive a placebo capsule PO daily, days 1, 3 and 5, together with a prophylactic dose of low molecular weight heparin (LMWH) or therapeutic dose if needed due to previous comorbidity.
15810665|NCT04361630|Drug|FGF 2|Following a standard surgical protocol, rhFGF-2 impregnated membranes will be placed in sites with gingival recession.
15810666|NCT04361617|Behavioral|Daily consumption of tree nuts and extra virgin olive oil|All participants will receive a 4-week supply of extra virgin olive oil and tree nuts, including unsalted English walnuts, almonds or pistachios (approximately 3-day supply of each type). Participants will be asked to include in their normal diets these products and will be provided recipes and other information that will allow them to replace other foods with the nuts and oil. We will ask participants to consume one ounce of tree nuts per day and two tablespoons of EVOO per day by incorporating these foods into their diet.
15810667|NCT04361604|Biological|Biological collection (patients co infected HIV Sras-CoV-2)|Biological sampling (blood,saliva, tear urine, stool, respiratory tract, semen only for 20 patients, or other samples if indicated.)
15810668|NCT04361604|Other|Auto-questionnaires (patients co infected HIV Sras-CoV-2)|4 autoquestionnaires will be collected : HADS Hospital anxiety and depression scale, PCL-5 (post-traumatic stress disorder checklist version DSM-5), symptoms with the modified Justice Symptom Index PROQOL-HIV
15810669|NCT04361604|Other|Qualitative interviews (in 40 patients : 20 with COVID-19 and 20 without COVID-19)|Qualitative interviews will be realized in 40 patients (20 with COVID-19 and 20 without COVID-19)
15810670|NCT04361591|Other|Observational only|Observational Study
15810671|NCT04361578|Diagnostic Test|Magnetic resonance elastography|All patients enrolled will receive magnetic resonance elastography of the brain.
15810672|NCT04361552|Other|Best Practice|Receive standard of care
15810673|NCT04361552|Biological|Tocilizumab|Given IV
15810674|NCT04361526|Device|Cytokine Adsorption|Cytokine adsorption will be performed through a venous hemodialysis catheter, preferably jugular or femoral. The filtration system will be established with a cytokine adsorption cartridge in an hemoperfusion system using a blood flow rate of 150 - 200 ml/min. Adsorbent therapy will last 72 hours, changing cartridges every 24 hours. Prior to start, heparinization will be stablished by a 1mg/Kg iv Na heparin bolus plus iv perfusion. Activated Partial Thromboplastin Time (aPTT) control will be performed every 6 hours, with a goal range between 60 and 80 seconds.
15810675|NCT04361513|Drug|Bupivacaine hydrochloride 0.5% (Marcaine, Pfizer)|3 point genicular nerve block
15810676|NCT04361513|Drug|triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip)|intra-articular injection of triamcinilone
15810677|NCT04361500|Device|Seraph 100|Seraph 100 therapy during a COVID-19 infection
15810678|NCT04361487|Device|NOVOSTITCH PRO Meniscal Repair System|Standard of care surgery with in which the meniscus is repaired using NOVOSTITCH PRO
15810679|NCT04361474|Drug|Budesonide Nasal|Nasal irrigation with budesonide and physiological saline morning and evening, for 30 days, in addition to olfactory rehabilitation twice a day.
15810680|NCT04361474|Other|Physiological serum|Nasal irrigation with physiological saline morning and evening, for 30 days, in addition to olfactory re-education twice a day.
15810681|NCT04361461|Drug|Hydroxychloroquine Sulfate|400 mg orally, every 12 hours x 2 doses (loading dose) and then 400 mg, once daily, orally, for 10 days.
15810682|NCT04361461|Drug|Hydroxychloroquine Sulfate + Azythromycin|400 mg, orally, every 12 hours x 2 doses (loading dose) and then 400 mg, once a day, orally, for 10 days associated with azithromycin, intravenously or orally, 500 mg / day, for 1 day and then 250mg / day for another 4 days.
15810683|NCT04361448|Other|samling of oropharynx and nasopharynx|Three different swabs will be taken of each participant: 1 oropharyngeal swab and 2 nasopharyngeal swabs
15810684|NCT04361435|Procedure|Chest physiotherapy using a non-invasive oscillating device|NIOD will be implemented on four different parts of the chest walls, 3 minutes for each part and 12 minutes in total per each session. Left and right front and posterior chest walls will be stimulated, particularly, on the anterior chest, intercostal spaces 1-2 above nipple line and lateral side of the mid-clavicular line 1-2 below intercostal spaces. The intensity of the NIOD can be selected between 80-100%, which is pre-specified on the machine.
15810685|NCT04361422|Drug|Isotretinoin Only Product in Oral Dose Form|assess antiviral efficacy, tolerability and safety of oral isotretinoin in the treatment of COVID-19 versus combined oral isotretinoin with standard therapy for COVID-19 versus the standard therapy alone.
15810686|NCT04361409|Drug|Rituximab|375mg/m2 on Day-14 and Day-7
15810687|NCT04361409|Drug|Cisplatin|70mg/m2 on Day1
15810688|NCT04361409|Drug|Gemcitabine|1000mg/m2 on Day8
15810689|NCT04361396|Other|Collection of samples|Only in enrolled patient : different samples will be taken at different times of the surgery (3 samples of pneumoperitoneum, 1 sample of peritoneal effusion or peritoneal lavage fluid and 1 sample of bile, in case of cholecystectomy.
15810690|NCT04361383|Other|control group|the patient will receive general anesthesia
15810691|NCT04361383|Procedure|quadratus lumborum block type 3|patients will receive ultrasound-guided quadratus lumborum block type 3 with 30 ml of bupivacaine 0.25% followed by general anesthesia.
15810692|NCT04361383|Procedure|erector spinae plane block|patients will receive ultrasound-guided quadratus lumborum block type 3 with 30 ml of bupivacaine 0.25% followed by general anesthesia.
15810693|NCT04361370|Drug|Olaparib-Pembrolizumab-Bevacizumab|"Olaparib 300mg (twice daily [BID])
~Pembrolizumab 200mg every 3 weeks (Q3W) from 2nd infusion for up to 35 infusions
~Bevacizumab 15mg/kg or 7.5mg/kg every 3 weeks (Q3W)"
15810694|NCT04361357|Other|whey protein|whey protein powder was added on the basis of standardized enteral nutrition preparation.
15810695|NCT04361344|Biological|blood samples|Clinical examination and blood samples will be done at inclusion (day 0), at day 7 (between day 4 and exit from intensive care) and at day 60.
15810696|NCT04361331|Drug|Lenvatinib combined with gemox|Arm2: Lenvatinib + gemox
15810697|NCT04361331|Drug|Toripalimab combined with lenvatinib|Toripalimab combined with lenvatinib
15810698|NCT04361318|Combination Product|Hydroxychloroquine plus Nitazoxanide|Both hydroxychloroquine & nitazoxanide will be administered orally to participating patients
15810699|NCT04361318|Other|Standard care|"Oxygen administered via ventilator. In addition, antipyretic paracetamol may be added if necessary"
15810700|NCT04361305|Drug|Dapoxetine|30 mg tablets 1 to 3 hours before sexual activity prn (as needed) not to be taken more than once every 24 hours for 8 weeks Tadalafil 5 mg tablets every day for 8 weeks
15810701|NCT04361305|Drug|Tadalafil|5 mg tablets every day for 8 weeks
15810702|NCT04361305|Drug|Tadalafil|5 mg tablets every day for 8 weeks
15810703|NCT04361292|Procedure|INTRAUTERINE INSEMINATION|Intrauterine insemination (IUI) combined with ovarian stimulation, has been an extensively used procedure for the treatment of patients with unexplained infertility. The fact that IUI is less expensive, less invasive, and easier to perform than other assisted reproductive techniques makes it the first-line treatment option in infertility treatments. Sperm that have been washed and concentrated are placed directly into the uterus around the time of ovulation. All patients had ovulation induction with gonadotropins and ovulation was triggered by recombinant hcg.
15810704|NCT04361279|Drug|SIBP-02|Injection，100mg/10ml
15810705|NCT04361279|Drug|Rituximab|Injection，100mg/10ml
15810706|NCT04361266|Device|Rotium nanoscaffold|Rotium bioabsorbable nanoscaffold placed between bone-tendon interface of rotator cuff repair construct
15810707|NCT04361266|Procedure|Control arm rotator cuff repair|Standard rotator cuff repair without Rotium
15810708|NCT04361253|Biological|High-Titer COVID-19 Convalescent Plasma (HT-CCP)|250mL HT-CCP x2 doses given sequentially.
15810709|NCT04361253|Biological|Standard Plasma (FFP)|250mL FFP or FP24 x2 doses given sequentially.
15810710|NCT04361240|Radiation|Proton vs Photon Radiation|Assignment to proton vs photon by randomization on RadComp parent study.
15810711|NCT04361214|Drug|Leflunomide|Tolerability study of leflunomide 100 mg administered once daily for 3 days followed by 30 mg administered once daily for the duration of 2 - 7 days.
15810712|NCT04361201|Procedure|Ligament plastic surgery|Ligament plastic surgery of ankle under arthroscopy for recurrent instable ankle reason and failure of medical treatment.
15810713|NCT04361201|Diagnostic Test|RMI and ultrasound|RMI examination at 3 months on operated ankle, and 3 CT scan examinations with elastography module will be performed at planned timeframes.
15810714|NCT04361188|Procedure|MAC anesthesia|Patients receives DBS under monitored anesthesia care.
15810715|NCT04361188|Procedure|AAA anesthesia|Patients receives DBS under asleep-awake-asleep anesthesia.
15810716|NCT04361175|Drug|Letrozole|Each group will be followed up for ovulation by day 12 ovulation monitoring by Transvaginal ultrasound for mature griffian follicle and measure endometrial thickness and volume then day 21 test serum progesterone level to confirm ovulation and if pregnancy occurred confirm by serum pregnancy test at day 35 of the cycle and follow pregnancy till confirmed by fetal pulsation by ultrasound.
15810717|NCT04361175|Drug|Clomiphine Citrate|Clomiphine Citrate
15810718|NCT04361162|Drug|Nivolumab|Nivolumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. Nivolumab work by stopping various molecules on cancer cells and body cells from working against the immune system's natural fight against cancer
15810719|NCT04361162|Drug|Ipilimumab|Ipilimumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. Ipilimumab work by stopping various molecules on cancer cells and body cells from working against the immune system's natural fight against cancer
15810720|NCT04361162|Radiation|Radiation|3D Conformal Radiotherapy to shrink or kill tumors
15810721|NCT04361149|Drug|Capsaicin Topical Cream (0.075%)|Capsaicin cream will be administered as a topical skin cream
15810722|NCT04361149|Device|Delsys Trigno Galileo System|A wireless surface EMG device. The sensors will be placed on the trapezius and the infraspinatus muscle, and a recording will be performed.
15810723|NCT04361149|Device|Excaliber, Natus Medical|Intramuscular EMG machine. The intramuscular electrode will be inserted into the trapezius and a recording will be performed.
15810727|NCT04361123|Other|daily syndromic surveillance|Each volunteer will be securely linked to an Oracle developed, self-reporting online HIPAA-compliant data system through a secure app on their smartphone, tablet, or computer. Volunteers will report their illness symptoms daily, health seeking behavior and treatment, COVID-19 contacts, and, for health care workers, use of PPE.
15810728|NCT04361123|Diagnostic Test|monthly serologic IgM/G test|At baseline to measure seroprevalence, and once every month after to detect seroconversions, we will use serological antibody tests for SARS-CoV-2 on a sample of volunteers demographically representative of populations served by Atrium Health.
15810729|NCT04361110|Radiation|Computerized tomography scan of the abdomen|Non-specific abdominal ct´s with different phases and contrast +/-.
15810730|NCT04361097|Biological|Faecal microbiota transplant|Both groups will receive frozen capsules to be ingested orally (constituted of TMF or placebo according to the randomization) with a frequency of 15 capsules every 12hrs for 4 doses on days 1, 10 and 30 of the study. Each capsule should be ingested in a period no longer than 1 hour.
15810731|NCT04361097|Biological|Placebo|Both groups will receive frozen capsules to be ingested orally (constituted of TMF or placebo according to the randomization) with a frequency of 15 capsules every 12hrs for 4 doses on days 1, 10 and 30 of the study. Each capsule should be ingested in a period no longer than 1 hour.
15810732|NCT04361084|Other|traditional simulated training|traditional simulation using actors as standardised patients playing out scenarios plus pre and post questionnaires and semi structured interviews
15810733|NCT04361084|Other|mixed reality simulation|using immersive technologies to create a virtual reality simulated training scenario's plus pre an post questionnaires and semi structured interview's
15810734|NCT04361071|Device|stent|stent
15810735|NCT04361071|Device|plaque excision system|plaque excision system
15810736|NCT04361058|Drug|Nivolumab|At Day +50 (±10 days) post-allogeneic SCT, participants will be treated with Nivolumab. Nivolumab will be administered intravenously once every two weeks for a total of 4 treatments. Participants will initially receive nivolumab at a significantly reduced starting dose of 0.25 mg/kg. This dose was determined based on the incidence of increased aGVHD, which was noted after treatment post-SCT in previous studies. Nivolumab IV will be given every 2 weeks for 4 cycles. One dose of nivolumab is equivalent to one cycle. The first administration will be at Day +50 (±10 days), assuming the participant has not had any evidence of Grade II-IV aGVHD after allogeneic SCT and does not have any current evidence of any grade of aGVHD at the day of first application of nivolumab. Depending on emerging safety data, dose escalation cohorts will explore higher dose levels of nivolumab at 0.5 mg/kg and 1 mg/kg.
15810737|NCT04361045|Behavioral|StriveWeekly|"The intervention (app.striveweekly.com) delivered eight modules: introduction module, six skills modules, and wrap-up module. The two program brand name versions had identical content, but different aesthetic schemes. Modules were released week-by-week, and participants self-guided through content. To facilitate skills practice, every module was accompanied by: a weekly intro email and reminder emails; an extras section for tips/suggestions; and a weekly prize drawing. The Dashboard section of the intervention displayed user progress. The Campus section of this dashboard provided: campus-specific announcements; referrals to relevant campus wellness resources; and an anonymous livestream of all campus users' activity.
~Strategies/skills included: Psychoeducation; Self-monitoring; Behavioral activation; Cognitive restructuring; Sleep hygiene; Time management; Interpersonal avoidance exposures; Physical exercise; Mindfulness; Maintenance planning."
15810738|NCT04361032|Drug|Tocilizumab Injection|Tocilizumab (LOC) (8mg/ kg per day) (1 injection per infusion). Only on the 1st day (D0)
15810739|NCT04361032|Drug|Deferoxamine|Deferoxamine (Desferal 500 mg, powder, and solvent for IV solution for injection)
15810740|NCT04361019|Other|On-Line Survey|A survey has been sent by email to the students of the participating universities
15810741|NCT04361006|Device|Radiofrequency (RF)|Will be evaluated if percutaneous radiofrequency catheter ablation is superior to cryotherapy as treatment modality of para-hisian accessory pathways.
15810742|NCT04361006|Device|Cryotherapy (CRYO)|Will be evaluated if percutaneous cryotherapy catheter ablation is superior to radiofrequency as treatment modality of para-hisian accessory pathways.
15810743|NCT04360993|Radiation|Radiotherapy|Patients have received radiotherapy as a treatment modality for Head and neck cancer
15810744|NCT04360980|Drug|Colchicine Tablets|1.5 mg loading then 0.5 mg BID P.O
15810745|NCT04360967|Other|Standard Formula|Standard Formula
15810746|NCT04360967|Other|Nutrient-enriched Formula|Nutrient-enriched Formula
15810747|NCT04360954|Diagnostic Test|Diagnostic test|There is no intervention. This study will test deidentified archived biosamples.
15810748|NCT04360941|Drug|Palbociclib|Highly selective oral inhibitor of CDK4 and CDK6.
15810749|NCT04360941|Drug|Avelumab|Fully human IgG1 monoclonal antibody (mAb) binds to the PD-L1 cell surface ligand and blocks its interaction with the PD-1 cell surface receptor.
15810750|NCT04360928|Device|Lake Effect Zero Degree Knee Splint|Specific type of splint which utilizes an inflatable air pocket on the posterior aspect of the leg to provide a combination of bracing and splinting in full extension in the immediate postoperative period.
15810751|NCT04360928|Device|Standard Hinge Knee Brace|Standard knee brace used postoperatively after ACL reconstruction.
15810752|NCT04360915|Drug|ASK120067|Take ASK120067 tablets orally in first day at 160 mg in fast condition.
15810753|NCT04360915|Dietary Supplement|ASK120067 in fed condition|Take ASK120067 tablets orally in first day at 160 mg in fed condition.
15810754|NCT04360902|Other|Anemia Controller|"Model Predictive Controller software (called Anemia Controller) that utilizes our physiology-based erythropoiesis model to provide ESA dosing recommendations in order to guide a patient's Hgb level towards a predefined target value."
15810755|NCT04360889|Drug|Micronised purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin)|Micronised purified flavonoid fraction (diosmin+flavonoids expressed as hesperidin) is prescribed at a dose of 1000 mg / day Tocopherol is prescribed at a dose of 400 ME/ day
15810756|NCT04360889|Drug|Tocopherol|patients with lower limb lymphedema receiving conservative therapy (elastic compression, to which are added preparations with antioxidant endotheliotropic activity (Tocopherol-400 IU/day)
15810757|NCT04360889|Other|Elastic compression|patients with lower limb lymphedema receiving conservative therapy that includes only the use of elastic compression
15810758|NCT04360876|Drug|Dexamethasone injection|Dexamethasone intravenous 20mg daily for 5 days followed by 10mg daily for 5 days
15810759|NCT04360876|Drug|Placebos|Placebo delivered intravenously on the same dosing schedule as dexamethasone
15810760|NCT04360863|Other|Telephone survey|Participants will be asked to respond to a survey regarding their knowledge about the relationship between smoking and COVID-19, their smoking behaviors and readiness to quit during the pandemic.
15810762|NCT04360837|Procedure|alveolar recruitment|incremental and decremental positive end-expiratory pressure alveolar recruitment
15810763|NCT04360824|Drug|Intermediate dose thromboprophylaxis|2) Patients randomized to the intervention arm will receive intermediate-dose enoxaparin (1 mg/kg Subcutaneously daily if BMI<30kg/m2 or 0.5 mg/kg Subcutaneously twice daily if BMI ≥ 30kg/m2).
15810764|NCT04360824|Drug|Standard of Care thromboprophylaxis|Patients randomized to the standard of care arm will receive standard prophylactic dose enoxaparin (40 mg subcutaneously daily if BMI <30kg/m2 and 30 mg subcutaneously twice daily or 40 mg subcutaneously twice daily if BMI ≥ 30 kg/m2).
15810765|NCT04360811|Diagnostic Test|COVID 19 diagnostic test by PCR|"Inclusion of patients with clinical data (in a eCRF) and various samples collection according to the outcome of pregnancy
~Storage and freezing samples for subsequent analysis by RT-PCR COVID-19 (maternal saliva, cord blood, fetal stools, placenta, fetal tissue, amniotic fluid according to pregnancy outcomes) and by maternal and newborn and / or fetal serologies testing
~Pathological study of placentas and fetal autopsies
~Histology of positive COVID-19 placentas
~Brain and visceral histology of positive COVID-19 fetuses autopsied
~Analysis of patient comorbidities and comparison in the different groups
~Final statistical analysis"
15810766|NCT04360798|Other|Unilateral Exercise Group|Exercise programs will be practiced 60 days, 2 days a week for 4 weeks. The entire exercise protocol will be carried out under the supervision of a physiotherapist. During the treatment session, participants exercises will only be done for 60 minutes with the affected lower extremities.
15810767|NCT04360798|Other|Bilateral Exercise Group|Exercise programs will be practiced 60 days, 2 days a week for 4 weeks. The entire exercise protocol will be carried out under the supervision of a physiotherapist. During the treatment session, participants will complete their exercises with both lower extremities for 30 minutes.
15810768|NCT04360785|Drug|Methotrexate|Patients randomized in this arm will have one subcutaneous injection of methotrexate 15min before and one 24h after their first injection of adalimumab prescribed as usual
15810769|NCT04360772|Diagnostic Test|mHLA-DR|"Before treatment/ At inclusion/Day 0 : Collection of gender, date of birth, comorbidities, pathology implicating treatment by corticosteroids and other treatment administered at the time of inclusion.
~At Day 0, Month 1, Month 3, Month 6 : Blood sampling (3mL) to proceed to mHLA-DR measurement. At those time-points, results from lymphocytes immunophenotyping, C-reactive protein and numeration will be collected.
~At Month 24 : Collection from medical report of
~any infectious events that would have occured during the follow-up
~course of the disease with corticosteroids
~survival or death at 24 months of follow-up."
15810770|NCT04360759|Drug|Chloroquine or hydroxychloroquine|Chloroquine has in vitro antiviral activity against many viruses, including SARS-CoV-1 and SARS-CoV-2. Chloroquine inhibits coronavirus replication at in vitro concentrations that are not cytotoxic and within a range of blood concentrations achievable during standard antimalarial treatment. Chloroquine inhibits viral replication through interference with glycosylation of coronavirus ACE2 receptors, required for viral entry, and downstream phagolysosome alkalisation, interfering with the low-pH-dependent steps of viral fusion and uncoating. Chloroquine also has anti-inflammatory properties and could provide benefit through this mechanism in Covid-19, where a cytokine storm has been described in critically ill patients. Hydroxychloroquine is a less toxic metabolite of chloroquine, has similar anti-inflammatory properties, and is more potent against SARS-CoV-2 in vitro.
15810771|NCT04360746|Other|Pharmaceutical intervention|Pharmaceutical intervention will include a complete medication review by a clinical pharmacist with the following process: medication reconciliation, medication indication and dosage check, medication effectiveness and appropriateness assessment, drug-drug or drug-disease interactions check, medication duplications check, length and cost of treatment evaluation. The pharmacist will use the following tools: Medication appropriateness index (MAI), ACB (Anticholinergic cognitive burden) score and the using the assessment of underutilization (AOU) index.
15810772|NCT04360746|Other|Rehabilitation|A multidisciplinary team provided medical, nursing, physical, occupational, and social work interventions. Rehabilitation care include: (a) individual physical therapy (PT), 2 to 3 times a week; (b) 30 to 40 min of PT in an adapted fitness room, aerobic training on a treadmill with and without partial weight support and stationary bicycles, 2 to 3 times a week ; (c) 30 to 40 min of virtual reality training by performing challenging functional tasks, 2 times a week and (d) 30 to 45 min of individual occupational therapy (OT), cognitive evaluation and stimulation, safety education, and learning to use assistive devices, 3 times a week.
15810773|NCT04360733|Other|Blood draw|serial blood draw and subsequent deep immune phenotyping analysis, (ii.) immune activation assays, (iii.) transcriptome and (iv.) epigenome analysis in an overarching (v.) bioinformatics data analysis
15810774|NCT04360720|Drug|Antiplatelet Monotherapy|"All subjects randomized to Monotherapy Group will have acetylsalicylic acid discontinued immediately after randomization.
~Subjects randomized to Monotherapy Group will be treated with ticagrelor or prasugrel alone until the end of the study, at Month 12."
15810775|NCT04360694|Procedure|Incremental hemodialysis|58 patients will start renal replacement therapy (RRT) with an incremental hemodialysis (once-weekly or twice-weekly) regimen.
15810776|NCT04360694|Procedure|Conventional hemodialysis|58 patients will start renal replacement therapy (RRT) with the standard (thrice-weekly) hemodialysis regimen.
15810777|NCT04360681|Drug|Lofexidine|BID dosing, and a max daily dose of 1.6 mg/day
15810778|NCT04360681|Drug|Placebo oral tablet|Placebo
15810813|NCT04360421|Drug|Liposomal bupivacaine|"Patient's undergoing major extremity amputation and enrolled in the study as part of the experimental arm will, during their amputation operation, receive liposomal bupivicaine per recommended manufacturing dosing and administration in a field block for long-acting local anesthesia."
15810886|NCT04359771|Device|Diode micro-pulse laser|applying 810-nm infra-red diode laser in a micro-pulse mode over the macular area including the fovea
15810887|NCT04359758|Behavioral|Proactive Streamlined Genetic Education and Testing|This intervention consists of the proactive delivery of genetic education print materials followed by streamlined and facilitated access to genetic testing.
15810779|NCT04360668|Other|Muscle Energy Technique (MET)|The Contract-Relax Agonist-Contract (CRAC) technique will be used, which belongs to the broad MET group. The participant will be in the supine position. The therapist will set the cervical segment in the lateral flexion until a slight soft tissue tension is felt. The technique will consist of two stages. In the first phase (contraction phase), the upper trapezius will be activated against the therapist's resistance (shoulder girdle elevation) - 10 seconds. Then the person undergoing the procedure breathes in and out deeply. Then 10 seconds of antagonist group contraction (shoulder girdle depression) will be performed. Next, the therapist will passively move the participant's shoulder girdle towards the depression. Then the second phase will follow (stretching phase), during which the participant will passively lie in the back position for 30 seconds. Both phases will make up the therapeutic cycle. Each participant will have 5 cycles on each side of the upper trapezius.
15810780|NCT04360668|Other|Trigger Point Therapy (TPT)|The technique of Positional Release (PR) will be used, which is one of the broadly understood Trigger Point Therapy. It will consist in compressing the trigger point with a simultaneous shortening of muscle attachments (slight lateral flexion towards the relaxed muscle). The muscle on both sides will be treated. The pressure exerted by the therapist's pincer grip will be acceptable to the patient. The duration of the technique will be 2 minutes for each muscle. While performing this technique, the participant will passively lie on his back.
15810781|NCT04360668|Other|Muscle Energy Technique (MET) combined with Trigger Point Therapy (TPT)|For this type of intervention, TPT will first be performed on both sides of the upper trapezius muscle, followed by MET, which will also be performed bilaterally. The detailed method of performing the applied therapeutic techniques for the combined procedure will be identical as in the case of isolated (single) methods.
15810782|NCT04360655|Procedure|bronchoscopic microwave intervention|bronchoscopic microwave intervention
15810783|NCT04360655|Drug|anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy|anti-PD-1 / PD-L1 monoclonal antibody and chemotherapy
15810784|NCT04360642|Other|singing|Singing for Wellness will use an uncontrolled observational study design. Two mixed-cohort, 12-week community choirs will be delivered by experienced vocal practitioners in South Devon localities:
15810785|NCT04360629|Drug|Tranexamic Acid|Tranexamic Acid will be given through central vein
15810786|NCT04360629|Drug|normal saline|normal saline will be given through central vein
15810787|NCT04360616|Diagnostic Test|imaging|perform US and mammography examination
15810788|NCT04360603|Device|27G|using 27G vitrectomy system to perform standard transconjunctival sutureless vitrectomy
15810789|NCT04360603|Device|25G|using 25G vitrectomy system to perform standard transconjunctival sutureless vitrectomy
15810790|NCT04360590|Device|pressure support ventilation versus neurally adjusted ventilatory assist|All patients underwent three mechanical ventilation modes, lasting 1 hour each: pressure support mode, neurally adjusted ventilatory assist and again pressure support ventilation
15810791|NCT04360577|Procedure|acupuncture|Acupuncture at back-shu points according to heat-pain threshold measurement at 24 well-points, combing with electro-acupuncture at Baihui(GV20), Yintang(GV29), Neiguan(PC6), Zusanli(ST36), and Gongsun(SP4).
15810792|NCT04360564|Other|Recurrent pregnancy loss|As described before.
15810793|NCT04360551|Drug|Telmisartan 40mg|Angiotensin Receptor Blocker (ARB)
15810794|NCT04360551|Drug|Placebo|Placebo once daily
15810795|NCT04360538|Other|Quality of Life|Physical disability assessment tool
15810796|NCT04360538|Other|Impact Event Score|Psychological Sequelae assessment tool
15810797|NCT04360538|Other|Hospital anxiety and depression scale|Psychological Sequelae assessment tool
15810798|NCT04360525|Other|Reasons|Causes of sigmoid volvulus
15810799|NCT04360512|Procedure|Posteriorization of the talus|Three sets of a 30-s grade IV mobilization
15810800|NCT04360499|Other|Low- weight-high-repetitions training|LWHR refers to a specific form of resistance exercise which utilizes low weights and very high repetitions
15810801|NCT04360499|Other|Pilates training|Pilates style exercise training
15810802|NCT04360486|Biological|Anti-Sars-CoV-2 Convalescent Plasma|Fresh frozen plasma, Plasma Frozen for 24 hours (PF-24), or Liquid plasma
15810803|NCT04360473|Other|General anesthesia|Balanced general anesthesia. Induction with lidocaine, fentanyl, propofol and cisatracurium. Maintenance with sevoflurane.
15810804|NCT04360473|Drug|Ketamine plus general anesthesia|ketamine 0.3 mg / kg 15 minutes before balanced general anesthesia. Induction with lidocaine, fentanyl, propofol and cisatracurium. Maintenance with sevoflurane.
15810805|NCT04360473|Drug|Magnesium sulfate plus general anesthesia|Magnesium sulfate 40 mg / kg 15 minutes before balanced general anesthesia. Induction with lidocaine, fentanyl, propofol and cisatracurium. Maintenance with sevoflurane.
15810806|NCT04360473|Drug|ketamine plus magnesium sulfate plus general anesthesia|Ketamine 0.15 mg/kg plus magnesium sulfate 20 mg/kg 15 minutes before balanced general anesthesia. Induction with lidocaine, fentanyl, propofol and cisatracurium. Maintenance with sevoflurane
15810807|NCT04360460|Other|Immersive virtual reality + related functional translation into real-life|The experimental group will perform tasks in an immersive virtual reality setting designed to encourage functional task performance for 30 minutes. The patient will then be brought to a real-life setting and evaluated on similar task performances for an additional 30 minutes for a total of 60 minutes per day, 3 times a week for 2 weeks.
15810808|NCT04360460|Other|Immersive virtual reality + non-related translation into real-life|The control group will also be asked to perform tasks in an immersive VR setting for 30 minutes, however tasks will be unrelated to the tasks performed in the real-life setting in the following 30 minutes. The control group will also receive 60 minutes of therapy a day, 3 times a week, for 2 weeks.
15810809|NCT04360447|Device|Reformer Pilates|Reformer pilates was planned, suitable for the disabled, with an instructor for the patients in the study group for 8 weeks.
15810810|NCT04360447|Other|Home Exercise|A home exercise program with telephone monitoring was planned for the patients in the control group for 8 weeks.
15810811|NCT04360434|Drug|NI006|NI006 will be administered intravenously
15810812|NCT04360434|Drug|Placebo|Formulation buffer of NI006, matching volume of NI006 doses will be administered intravenously
15810879|NCT04359810|Biological|Convalescent Plasma (anti-SARS-CoV-2 plasma)|Convalescent Plasma that contains antibody titers against SARS-CoV-2
15810880|NCT04359810|Biological|Non-convalescent Plasma (control plasma)|Non-convalescent plasma (does not contain antibody titers against SARS-CoV-2)
15810814|NCT04360408|Other|Energy conservation education intervention for people with end-stage kidney disease receiving hemodialysis|The total program consisting of three educational sessions (at Week -1, week -3 and week -5) and one booster session (week -10) over a period of 12 weeks. Participants will receive individual, face to face education during their regular HD session. Education will be provided over 30-45 minutes for the first session, 30 minutes in the next two sessions and 30-45 minutes for the booster session. The lead researcher, who is a nurse, will deliver the entire intervention to avoid information bias. The simple language will be used, and emphasis will be given on the objectives of each session.
15810815|NCT04360395|Behavioral|Gait Therapy|The therapeutic gait training protocol will consist of 24-treatment sessions that will be performed 3 times-a-week for an 8-week period. All therapeutic exercises will be performed under the direction of a licensed pediatric physical therapist. Any sessions missed will be added on to the 8-week period. Each intervention session will consist of over-ground gait activities that will be completed in a 60 minute session with rests as needed. The key ingredients of the therapy will include: 1) activities of adequate intensity that promote gait adaptation and gait speed sustainment, 2) exploratory activities that enhance the somatosensory experience through rich/novel movement, and 3) optimally challenging activities that emphasize planning and problem solving that requires altering the leg kinematics to meet the environmental and task constraints.
15810816|NCT04360382|Other|ERACS|Pregnant women scheduled for cesarean section will be subjected to preoperative, intra-operative and postoperative nurse care aiming at early recovery.
15810817|NCT04360382|Other|Regular care|Usual care for all cases subjected to cesarean section at our hospital.
15810818|NCT04360369|Device|IOP with Goldmann Applanation Tonometer|Measurement of intraocular pressure (IOP) with Goldmann Applanation Tonometer. Measurement will be used to categorize each subject as having Low IOP (7 to 16 mmHg), Medium IOP (>16 to <23 mmHg), or High IOP (>23 mmHg).
15810819|NCT04360369|Device|IOP with comparator ORA G3 and ic100 tonometers|Measurement of IOP with Ocular Response Analyzer G3 and ic100 tonometers.
15810820|NCT04360369|Device|IOP with Tono-Vera Tonometer|Measurement of IOP with Tono-Vera Tonometer
15810821|NCT04360356|Combination Product|Ivermectin plus Nitazoxanide|Ivermectin 200 mcg/kg once orally on empty stomach plus Nitazoxanide 500 mg twice daily orally with meal for 6 days
15810822|NCT04360356|Other|Standard Care|Oxygen via Ventilators
15810823|NCT04360343|Drug|Film-coated tablet|uncoated tablet
15810824|NCT04360330|Radiation|Stereotactic Ablative Breast Radiotherapy|"Preoperative SABER: Participants will be treated with an assigned dose level of preoperative SABER, delivered in once a day, 5 fractions given on non-consecutive days, over a period of 2 weeks. In this phase I study, starting with dose level II, a dose level of preoperative SABER will be assigned per study dose-escalation design, treating 2 to 6 patients per dose level. The tested doses are the following:
~Dose Level I: 35 Gy (5 fractions of 7 Gy)
~Dose Level II (Starting Dose): 40 Gy (5 fractions of 8 Gy)
~Dose Level III: 45 Gy (5 fractions of 9 Gy)
~Dose Level IV: 50 Gy (5 fractions of 10 Gy)"
15810825|NCT04360317|Drug|Combination of SH003 and Docetaxel|Combination of SH003 and Docetaxel
15810826|NCT04360304|Device|Echocardiographic exam|"An echocardiographic exam is realised after inclusion, measuring especially :
~LVOT VTI
~Respiratory variation of inferior veina cava diameter For theses two measurements, the manual method is first recorded, and then the automated one is done.
~For patients that need fluid resuscitation of at least 250mL in less than 10minutes (indication at the discretion of the physician in charge of the patient), a second echocardiography is done according to the same protocol described before."
15810827|NCT04360291|Other|Eye tracker|In visual search tasks, participants will sit in front of a screen and observe during each visual scene for a maximum of 45 seconds. Their eye movements will be recorded
15810828|NCT04360265|Biological|ABO-102|Study drug is not administered in this trial. Participants who received ABO-102 in a previous trial will be evaluated for long-term safety and efficacy.
15810829|NCT04360252|Other|Gracie Diet|"The patient is going to have an encounter with the nutritionist (either face to face or by phone call) and she will provide patient with the requisite nutritional information and will guide patient on how to properly adhere to the diet.
~The session is designed to: answer patient questions, educate patients so that patients understand the underlying nutritional concepts that the diet is based upon, support patients by empowering the patients to make healthy nutritional choices consistent with the diet, educate patients regarding the appropriate combinations of healthy foods, and help patients to develop menu samples based on the Gracie Diet when there is interest."
15810830|NCT04360239|Dietary Supplement|Fish Oil|Fish-oil formulation of two capsules twice daily (3000 mg of EPA and DHA).
15810831|NCT04360226|Other|Non-interventional|Non-interventional, subjects will only have routine testing (blood biomarkers, spirometry, peak inspiratory flow measurements) and be asked to complete questionnaires.
15810832|NCT04360213|Device|Advanced multimodal wireless vital signs monitor|Investigators have developed a lightweight, stretchable 'skin-like' membranes, called skin sensors. These small, paper-thin monitors were created by matching the mechanical properties of skin, and can be applied to the skin's surface without skin disturbance. Each patch is encapsulated using medical grade materials and applied using single use medical grade skin adhesive integrated with eco-fused fabric (moisture wicking layer between adhesives). The adhesive may be changed between uses, and the device itself can be cleaned with Super Sani-Cloth®, commonly used in the hospital setting.
15810833|NCT04360187|Drug|Crisaborole Ointment|Crisaborole ointment 2%
15810834|NCT04360187|Drug|Crisaborole Placebo Vehicle|Placebo for crisaborole ointment
15810835|NCT04360174|Drug|OTX-TIC|OTX-TIC implant is injection in the anterior chamber of the eye
15810836|NCT04360161|Device|swept-source optical coherence tomography|Aswe pt-source OCT (CASIA SS-1000; Tomey Corporation, Nagoya, Japan), which is specifically designed for anterior segment imaging using a 1310 nm wavelength with a scan speed of 30,000 A-scans per second and an axial resolution of <10 μm.
15810881|NCT04359797|Other|Prone|Provider-recommended guidance on prone positioning of patients
15810882|NCT04359797|Other|Usual Care|No provider-recommendation, patients will remain in their natural choice of position
15810883|NCT04359784|Biological|Anakinra|Given SC
15810884|NCT04359784|Biological|Axicabtagene Ciloleucel|Given via infusion
15810885|NCT04359771|Device|Yellow micro-pulse laser|applying 577-nm yellow laser in a micro-pulse mode over the macular area including the fovea
15810837|NCT04360148|Dietary Supplement|very-low-calorie-ketogenic-diet|VLCKD-group will undergone to VLCKD for 8 weeks. VLCKD is based on protein preparations of high biological value. Total daily energy intake is < 800 kcal.Daily carbohydrate intake is lower than 30 g/day, while daily protein intake is approximately 1.2-1.5 g/kg of ideal body weight. The following four weeks, carbohydrates are gradually reintroduced, starting from foods with the lowest glycemic index (fruit, dairy products), followed by foods with moderate and high glycemic index (bread, pasta and cereals). The goal is to achieve a hypocaloric balanced diet (HBD), as well as the controlled group. From the 12th week to the 24 th week, all subjects enrolled will continue follow-up with HBD.
15810838|NCT04360148|Other|hypocaloric-balanced-diet|HBD-group will undergone to hypo caloric balanced diet for 24 weeks. Total daily average energy intake is 1500-1600 kcal/day. 30% of total daily energy is composed by lipids (10% MUFA, 10% PUFA, 10% SFA), 55% carbohydrates, while daily protein intake is approximately 0.8-1.5 g /kg of ideal body weight.
15810839|NCT04360135|Drug|Acetaminophen|Preemptive acetaminophen the day before surgery
15810840|NCT04360135|Drug|Placebo|Preemptive placebo the day before surgery
15810841|NCT04360122|Drug|Levamisole|Levamisole (150 mg/day for two days per week for 2 months
15810842|NCT04360122|Drug|Isoprinosine|Isoprinosine (1 g 3 times per day daily) for two months
15810843|NCT04360122|Drug|Levamisole and Isoprinosine|Levamisole (150 mg/day for two days per week for 2 months and Isoprinosine (1 g 3 times per day daily) for two months
15810844|NCT04360096|Drug|ZYESAMI™ (aviptadil acetate)|Inhaled ZYESAMI™ (aviptadil acetate) 100μg 3x daily by mesh nebulizer
15810845|NCT04360096|Drug|Placebo|Normal Saline Inhalation
15810846|NCT04360096|Device|Nebulized administration of ZYESAMI™ or Placebo|Use of 510(k) cleared mesh nebulizer to deliver investigational product
15810847|NCT04360083|Other|Collected data from Rhône RéPPOP database|BMI Z-scores at the start and the end of RéPPOP care programs.
15810848|NCT04360083|Other|telephonic questionnaire|Collected data though the telephonic questionnaire : current declared BMI Z-score.
15810849|NCT04360070|Drug|Ketamine Hydrochloride|Parenteral General Anesthetic
15810850|NCT04360057|Other|PMD|A script used to train the physician to engage with the patient in the topic of hand hygiene compliance used on the initial visit.
15810851|NCT04360057|Other|PMDPlus|A script used to train the physician to engage with the patient in the topic of hand hygiene compliance on follow up visits
15810852|NCT04360044|Drug|THC ~5%|4 puffs of vaporized flower containing THC ~5%
15810853|NCT04360044|Drug|CBD ~12%|4 puffs of vaporized flower containing CBD ~12%
15810854|NCT04360044|Drug|THC ~5% and CBD ~12%|4 puffs of vaporized flower containing THC ~5% and CBD ~12%
15810855|NCT04360044|Drug|Sham Cannabis|4 puffs of vaporized flower from which the THC and CBD have been extracted
15810856|NCT04360031|Drug|Tacrolimus|Tacrolimus and Mycophenolate Mofetil are given in accordance with patient's current regimen
15810857|NCT04360018|Other|Alcohol beverage|High-proof alcohol (e.g., Everclear) will be mixed with orange juice in an approximately 1:3 ratio and split evenly into two drinks. After splitting the orange juice into two cups, a small amount (approx. 6 ml) of high-proof alcohol will be floated on top of the beverage.
15810858|NCT04360018|Other|Placebo beverage|The final drink will have the same volume of liquid as the alcohol beverage.
15810859|NCT04360005|Drug|Asciminib|Asciminib 20 or 40 mg strength tablets will be administered orally twice-daily, without food
15810860|NCT04359992|Other|Extra blood sample|3 extra blood samples at day 0, 2 and 7
15810861|NCT04359979|Drug|Tamsulosin|selective alpha1 receptor antagonist
15810862|NCT04359966|Drug|Esomeprazole 40mg, Clarithromycin 500 mg, Metronidazole 400 mg,|First line therapy
15810863|NCT04359966|Drug|Esomeprazole 40mg, Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mg|First line therapy second arm
15810864|NCT04359966|Drug|Esomeprazole 40mg, Bismuth subcitrate 120 mg, Amoxicillin 500 mg, Metronidazole 400 mg|Second line therapy for Helicobacter pylori infection
15810865|NCT04359966|Drug|Esomeprazole 40mg, Amoxicillin 500 mg, Levofloxacin 500 mg|Second line therapy for Helicobacter pylori infection second arm
15810866|NCT04359953|Drug|Hydroxychloroquine|Hydroxychloroquine 2 x per day during 14 days
15810867|NCT04359953|Drug|Azithromycin|Azithromycin 2 x per day during 14 days
15810868|NCT04359953|Drug|Telmisartan|Telmisartan 2 x per day during 14 days
15810869|NCT04359940|Diagnostic Test|Cardiac MRI|For clinical surveillance
15810870|NCT04359901|Biological|SARILUMAB|Single dose of 400 mg subcutaneous sarilumab
15810871|NCT04359888|Other|Multi-Component Exercise Training (MCET)|Three one-hour training sessions per week for six weeks in Multi-Component Exercise Training (MCET). (See Study Design)
15810872|NCT04359888|Other|Balanced Reach Training (BRT)|Three one-hour training sessions per week for six weeks in the Balanced Reach Training Protocol (BRTP) (See Study Design).
15810873|NCT04359875|Behavioral|Phone-call screening and management by a medical student/general practitioner tandem|"Systematic phone contact of the patient by a medical student, under the indirect supervision of the general practitioner. This phone contact will be standardized with 3 questions to ask to the patient:
~How are you doing? (with a Likert scale from 1=very bad to 10=very well)
~Would you have made an appointment with your general practitioner if there had not been COVID19 epidemic and containment?
~Would you like an appointment with your doctor and / or has your doctor ever contacted you? In view of the answers to these 3 questions, the general practitioner will decide whether it is necessary to propose a consultation or a teleconsultation to the patient, taking into account his/her medical background."
15810874|NCT04359862|Drug|Sevoflurane|25 patients sedated with Sevoflurane via inhalation, starting with 6 ml/h and changing every 15 minutes until an adequate level of sedation is achieved ( BIS 40-50)
15810875|NCT04359862|Drug|Propofol|25 patients standard sedation with intravenous propofol, starting with 2 mg/kg/h and changing every 15 minutes until an adequate level of sedation is achieved ( BIS 40-50)
15810876|NCT04359836|Other|There is no intervention in this study|There is no intervention in this study
15810877|NCT04359823|Drug|Lovastatin 2%, 2% Cholesterol Cream|Patients selected to the study will be randomly assigned to this arm. They will have a 50% chance of being placed in this arm compared to the other arm.
15810878|NCT04359823|Drug|Lovastatin 2%|Patients selected to the study will be randomly assigned to this arm. They will have a 50% chance of being placed in this arm compared to the other arm.
15810888|NCT04359758|Behavioral|Usual Care|This intervention consists of a standard genetic referral letter that notified the participant that he qualified for genetic referral, recommends the scheduling of a genetic counseling session and provides a telephone number for scheduling.
15810889|NCT04359732|Other|hybrid PET/MRI|An additional intermediate 18-FDG PET/MRI will be performed during neoadjuvant chemo-radiation therapy. Routine pre-treatment work-up PET/MRI will replace PET alone.
15810890|NCT04359680|Drug|Nitazoxanide|Nitazoxanide 600 mg administered orally twice daily for six weeks
15810891|NCT04359680|Drug|Placebo|Placebo administered orally twice daily for six weeks
15810892|NCT04359680|Dietary Supplement|Vitamin Super B-Complex|Vitamin Super B-Complex administered orally twice daily to maintain the blind
15810893|NCT04359667|Drug|Tocilizumab 20 MG/ML Intravenous Solution [ACTEMRA]|1 - 8 mg per kg of body weight once, maximal 800 mg per dose (can be repeated once more after 12 hours, per clinician's assessment)
15810894|NCT04359654|Drug|Dornase Alfa Inhalation Solution [Pulmozyme]|Nebulised Dornase alfa 2.5mg bd for 7 days
15810895|NCT04359641|Device|CoMET Display|Display and presentation of predictive monitoring score CoMET
15810896|NCT04359615|Drug|Favipiravir|This will be drug only used in the intervention arm of our study, designed mainly to assess the additional efficacy and safety of Favipiravir in COVID-19 patients.
15810897|NCT04359615|Drug|Hydroxychloroquine|This Drug will be used in all arms as mandated by our governmental guidelines.
15810898|NCT04359576|Diagnostic Test|Primary and secondary hemostasis|Focus on platelet aggregation, primary and secondary hemostasis parameters
15810899|NCT04359563|Behavioral|Mindfulness-Based Intervention|"The MBI consists of four 2h online group sessions spread over eight weeks. In between sessions, online support will be offered to assist participants in their practice. Each session consists of guided mindfulness exercises (e.g., focus on the breath, body scan, breathing space, mindful yoga, insight meditation, walk meditation), sharing of experiences of these exercises, reflections in small groups, psycho-education (e.g., stress, depression, self-care), and review of home practices. An overview of core elements is given in Van der Gucht et al. (2017b).
~The MBI is supported by homework assignments and audio material. Groups will include 5 participants, yielding 6 groups in total. The MBI will be delivered by highly qualified certified trainers with more than 10 years of experience in mindfulness meditation and extensive experience working with adolescents. Trainers will attend inter- and supervision moments on a regular basis to check treatment fidelity and trainer adherence."
15810900|NCT04359550|Biological|Recombinant human anti-PD-L1 monoclonal antibody (ZKAB001)|Recombinant human anti-PD-L1 monoclonal antibody (ZKAB001)
15810901|NCT04359550|Other|placebo|placebo
15810902|NCT04359537|Drug|Hydroxychloroquine Sulfate 200 MG|Hydroxychloroquine Sulphate 200 mg tablets will be prescribed and instituted orally at the doses and regimens described
15810903|NCT04359537|Other|Placebo|Control group will receive a Placebo tablet. Placebo 200mg will be given on Day 1 followed by Placebo 200mg every three weeks.
15810904|NCT04359524|Dietary Supplement|Vitamin D3 (1200 IU/30µg)|
15810905|NCT04359524|Dietary Supplement|Placebo|Placebo oil capsule
15810906|NCT04359511|Drug|Prednisone|prednisone 0.7 mg/kg/d (PO)
15810907|NCT04359511|Drug|Hydrocortisone|hémisuccinate d'hydrocortisone 3,5 mg/kg/jour (IV)
15810908|NCT04359485|Procedure|Glycolic acids peel 70%|Glycolic acid peel 70% applied in 3 coats medium depth
15810909|NCT04359485|Other|Saline|Sodium chloride
15810910|NCT04359472|Device|Application of Autologous Amniotic Fluid|Collection and reapplication of amniotic fluid at wound layers during a cesarean section.
15810911|NCT04359446|Procedure|NC ( Non- Compliant) Balloon dilatation|NC Balloon dilatation at pressure > NC-RBP (18-20 atm) with > 1 long inflation (> 20 minutes each)
15810912|NCT04359446|Procedure|Laser Excimer + NC Balloon|Laser Excimer + NC Balloon dilatation at pressure > NC-RBP (18-20 atm) with > 1 long inflation (> 20 minutes each)
15810913|NCT04359433|Behavioral|Exercise programme|"Exercise programme includes 8 anaerobic movements choosen from Tabata. This exercise programme workout is aimed at body fat reduction, and the structure is as follows:
~8 anerobic movements in 20 seconds is a set
~Rest for 10 seconds before another set
~Finish 4 sets every time, it shall take you 4 minutes
~Do 4 sets 2 to 3 times a week"
15810914|NCT04359420|Other|BC-Predict|BC-Predict is an automated system for offering an assessment of breast cancer risk to women when they receive their NHS Breast Screening Programme invitation, and generating letters to feedback this risk to women and relevant healthcare professionals. Women at higher risk are offered chemoprevention drugs and additional mammography
15810915|NCT04359420|Other|NHS Breast Screening Programme|usual care from NHS Breast Screening Programme, consisting of mammography every three years for most women.
15810916|NCT04359407|Other|Prone positioning|Change the positioning of the COVID patients who are intubated and mechanically ventilated from supine to prone
15810917|NCT04359394|Other|biological sampling|In order to investigate the level of molecular pathophysiology, blood and punch biopsies will be collected of each patient. In up to two relatives per patient, 30mL blood will be collected only once.
15810918|NCT04359394|Other|Phenotypic description|Phenotypic characterization of the patient's clinical features
15810919|NCT04359394|Other|Photography|All affected areas will be photographed at each visit with 2-dimensional standardized photography
15810920|NCT04359381|Other|kinesiotaping application|kinesiotaping was applied once the menstrual pain begins (one day before menstruation) for periods of 4 to 5 days until the pain disappears and then removed it. Kinesiotaping was used for 3 successive menstruations.
15810921|NCT04359381|Other|Pilate exercises program|Each girl in group (B) was engaged in a supervised pilate exercises program for 30 minutes per session for 3 days/week for 12 weeks except days of menstruation. Participants would be oriented to wear comfortable clothes .
15810922|NCT04359368|Other|collection of patient data|Data collection (history, clinical presentation, medication, complications, laboratory testing) will be performed from patient records stored in the protected electronic patient system ISMed (Integrated System for Medical Diagnostic) of patients with HSRs to NDIPs.
15810923|NCT04359355|Device|Artificial Intelligence System for Detection of colorectal polyps|In this group, an artificial Intelligence System will be used for computer-aided diagnosis of colorectal polyps. Diagnostic Performance of the artificial intelligence System for detection of polyps will be compared against Operator-based detection in the same group
15810924|NCT04359342|Dietary Supplement|HIIT + protein|"8-week supervised exercise program consisting of high-intensity interval training (HIIT).
~HIIT: 10x1 min at 85-95% HRmax divided by low intensity recovery periods. Three exercise sessions per week. Participants receive 40 g of a commercially available protein supplement administered as a shake after every exercise session."
15810925|NCT04359342|Dietary Supplement|HIIT + placebo|"8-week supervised exercise program consisting of high-intensity interval training (HIIT).
~HIIT: 10x1 min at 85-95% HRmax divided by low intensity recovery periods. Three exercise sessions per week. Participants receive 40 g of a commercially available iso-caloric placebo (Maltodextrin) administered as a shake after every exercise session."
15810926|NCT04359342|Dietary Supplement|HIIT and resistance training + protein|"8-week supervised exercise program consisting of high-intensity interval training (HIIT) and resistance training (RST).
~HIIT: 5x1 min at 85-95% HRmax divided by low intensity recovery periods. RST: 3-set resistance training using weight machines to train all major muscle groups with an individual intensity corresponding to 70-80% of one repetition maximum. Two exercise sessions per week. Participants receive 40 g of a commercially available protein supplement administered as a shake after every exercise session."
15810927|NCT04359342|Dietary Supplement|HIIT and resistance training + placebo|"8-week supervised exercise program consisting of high-intensity interval training (HIIT) and resistance training (RST).
~HIIT: 5x1 min at 85-95% HRmax divided by low intensity recovery periods. RST: 3-set resistance training using weight machines to train all major muscle groups with an individual intensity corresponding to 70-80% of one repetition maximum. Two exercise sessions per week. Participants receive 40 g of a commercially available iso-caloric placebo (Maltodextrin) administered as a shake after every exercise session."
15810928|NCT04359329|Drug|Estradiol patch|Participant receives estradiol 100 micrograms/day for 7 days through a patch applied on the skin
15810929|NCT04359316|Drug|Hydroxychloroquine|This Drug will be used in all arms as mandated by our governmental guidelines.
15810930|NCT04359316|Drug|Azithromycin|This will be drug only used in the intervention arm of our study, designed mainly to assess the additional efficacy and safety of Azithromycin in COVID-19 patients.
15810931|NCT04359303|Other|Systemic indirect endovenous ozone therapy|200 mL at 40 mcg/mL of medical ozone / oxygen in 200 mL of patients blood mixed in an homologated device for the procedure.
15810932|NCT04359290|Drug|Ruxolitinib administration|Ruxolitinib will be administered p.o. or by gavage feeding starting with 2 x 10mg or 2 x 15mg bid dose at day 1 according to the investigator's decision and can be increased up to 2 x 15mg bid from day 2 to day 28 (max) (depending on platelet counts and renal function). Ruxolitinib will be administered in the morning and evening. Dosing will be adjusted according to toxicity and kidney function.If the patient is discharged before day 28, the therapy will be discontinued for discharge.
15810935|NCT04359264|Other|Cash transfer|Cash transfer of $1000
15810936|NCT04359251|Other|Gas exchanges at different PEEP|Gas exchanges measurement at different PEEP
15810937|NCT04359251|Other|lung mechanics at different PEEP|lung mechanics measurement at different PEEP
15810938|NCT04359251|Other|Hemodynamics changes at different PEEP|Hemodynamics changes measurement at different PEEP
15810939|NCT04359238|Behavioral|Individualized excercise|The participants in the intervention group carry out regularly endurance and strength exercises.
15810940|NCT04359225|Other|3D Telemedicine|Telemedicine using 3D broadcast to clinician
15810941|NCT04359225|Other|2D Telemedicine|Standard care with 2D telemedicine
15810942|NCT04359212|Drug|thromboprophylaxis with low-molecular-weight heparin or fondaparinux|thromboprophylaxis with low-molecular-weight heparin or fondaparinux
15810943|NCT04359199|Radiation|Radiation Therapy|Routine radiation dosing (approximately 70 Gy in 35 fractions over 6.5 weeks) to the head and neck for the treatment of head and neck cancer
15810944|NCT04359199|Drug|Cetuximab|Cetuximab is an epidermal growth factor receptor (EGFR) inhibitor used for the treatment of head and neck cancer
15810945|NCT04359199|Drug|Chemotherapy|Cisplatin is a chemotherapy medication used to treat a number of cancers, including head and neck cancer
15810946|NCT04359199|Drug|Immunotherapy|"Keytruda or Pembrolizumab is a highly selective humanized monoclonal IgG4 antibody directed against the PD-1 receptor on the cell surface.
~Opdivo or Nivolumab is a targeted therapy. It is a human programmed death receptor-1 (PD-1) blocking antibody.
~Imfinzi or Durvalumab is an anti-cancer (antineoplastic) drug. This medication is classified as an Anti-PD-L1 monoclonal antibody."
15810947|NCT04359186|Other|Treatment Interruption Arm|Individuals with HIV on suppressive ART will interrupt their ART.
15810948|NCT04359160|Device|Orthense, Orthense, Digikare Inc. Blagnac, France|Mobile-app follow-up care, with questions and score
15810949|NCT04359160|Other|Questionnaire|Paper questionnaire follow-up, with questions and score
15810950|NCT04359147|Drug|"Yohimbine"|Effects on neural correlates of decision-making under risk and selective attention to threat
15810951|NCT04359147|Drug|"Hydrocortisone"|Effects on neural correlates of decision-making under risk and selective attention to threat
15810952|NCT04359147|Drug|"Yohimbine + Hydrocortisone"|Effects on neural correlates of decision-making under risk and selective attention to threat
15810953|NCT04359147|Drug|"Placebo"|Effects on neural correlates of decision-making under risk and selective attention to threat
15810954|NCT04359121|Other|Questionnaires for specific phobia|Questionnaires will be used.
15810955|NCT04359108|Device|Navigation System for Users of a Visual Prosthesis|We use common psychophysical judgments such as the following: discriminating between two alternatives by saying which is present in the field of view, touching a tablet computer to indicate the apparent location of a target in the frontal plane, and looking for targets by rotating the head and pointing when one is found. We will compare user performance using the Basic system with user performance using the Augmented and Augmented + Modal systems where contextual information associated with the task is conveyed to users via enhanced visual, auditory, and haptic modalities.
15810956|NCT04359095|Drug|Emtricitabine/tenofovir|Generic drug distributed by the Colombian Health System for Human Immunodeficiency Virus (HIV) positive patients It is classified as an anti infectious drug and its current indications include HIV infections.
15810957|NCT04359095|Drug|Colchicine Pill|Generic drug distributed by the Colombian Health System as an insurance treatment for Gout. It has been suggested that colchicine would be useful in SARS Covid 19 becouse its antiinflammatory effects through reduction of cytokine levels as well as the activation of macrophages, neutrophils, and the inflammasome
15810958|NCT04359095|Drug|Rosuvastatin|Generic drug distribute by the Colombian Health System. It is used in people with High levels of cholesterol. An action against the main protease (Mpro) of COVID 19 virus has been described, There is evidence suggesting that statins could exert anti Covid 19 action and the infectivity of enveloped viruses
15810959|NCT04359095|Other|Standard treatment|Standard treatment n, multiple organ failure related to the acute infection including respiratory support (oxygen, positive end-expiration pressure with external devices or invasive ventilatory support), cardiovascular, renal, haematological or coagulation, or co-infection with bacterial or mycotic organisms, standard care to prevent pressure ulcers or other care required by the patient. No viral therapies are included.
15810960|NCT04359082|Dietary Supplement|CocoaVia supplement|CocoaVia is a dietary supplement that has concentrated bioflavanols of 225 mg flavanols per pill along with 30 mg theobromine and 10 mg caffeine
15810961|NCT04359082|Other|Placebo Pill|Placebo pill has no bioflavanols with 30 mg theobromine and 10 mg caffeine
15810962|NCT04359069|Other|Urinary catheter removal on postoperative day 1|Urinary catheter will be removed on day 1 (experimental) instead of day 3 (standard of care).
15810963|NCT04359069|Other|Urinary catheter removal on postoperative day 3|Urinary catheter will be removed on day 3 (standard of care)
15810964|NCT04359056|Other|Clinical pharmacy activities along the care pathways|"PICC line implantation: Optimize the logistics circuit of the PICC line by rationalizing orders through the evaluation of potential losses.
~Ensure the due traceability of the implanted medical device. Discharge order : Analysis, optimization and pharmaceutical interventions if necessary Discharge Pharmaceutical Interview : Discussion with the patient, Information about the PICC line maintenance and associated therapies, Information about the prescribed drugs.
~Call to the community pharmacist to transfer the patient's prescription. Follow-up calls for 3 months after discharge
~Patients: Two calls the first week after implantation, then one call per month for a maximum of 3 months, Clinical data collection :Pharmaceutical advices if necessary
~Liberal nurses: same frequency, Clinical data collection, Pharmaceutical advices if necessary
~Community pharmacist: one call per month, information relevant to the patient's follow-up will be collected."
15810965|NCT04359043|Behavioral|Mediational Intervention for Sensitizing Caregivers (MISC)|MISC is an intervention that focuses on increasing the caregiving capacity of the caregiver by enhancing a set of emotional and cognitive components that collectively, sensitizes the caregiver to the emotional and cognitive needs of the child.
15810966|NCT04359043|Behavioral|Treatment as Usual|Treatment as Usual was delivered by community-based organization caseworkers. It consists of a nutritional curriculum of the same dosage and time commitment as the experimental condition, but with no caregiving component.
15810967|NCT04359030|Diagnostic Test|Multislice CT scanning for aortic wall calcification|Multislice CT scanning for aortic wall calcification
15810968|NCT04359030|Diagnostic Test|Transthoracic stress echocardiography|Transthoracic stress echocardiography
15810969|NCT04359017|Drug|Lidocaine 1% Injectable Solution|The lidocaine will be injected into the fracture hematoma using buffered 1% lidocaine solution at a dose of 2.5 mg/kg (0.25 mL/kg), maximum dose 100 mg (10 mL). Using a 30-gauge needle to minimize pain, a small skin wheal of lidocaine will be injected over the fracture site. A 21-gauge needle will then be attached to the lidocaine filled syringe and passed through the skin wheal used to inject the lidocaine into the fracture hematoma. To confirm the needle is in the fracture hematoma, a small amount of blood from the hematoma will be aspirated into the syringe filled with lidocaine before injecting the lidocaine, as in standard practice.
15810970|NCT04359004|Other|Vagus Nerve Stimulation (VNS)|Vagus Nerve Stimulation (VNS) will be performed percutaneously through the internal jugular vein during the patient's routine VT ablation procedure. The nerve will be stimulated using standard pacing systems used for clinical purposes. A series of stimulation frequencies and pulse widths will be used to define optimal effects and 'dosing'. Activation recovery interval (ARI) will be measured from the unipolar electrograms. In addition, heart rate and blood pressure responses will be continuously recorded.
15810971|NCT04358991|Drug|Ceftazidime-avibactam|collection of blood samples around clinical dosing immediately pre-dose, then at the following times thereafter: 1, 2, 4, 6, 8, and 12 hours and EMR review.
15810972|NCT04358978|Procedure|laparoscopic sacral colpopexy with posterior mesh no attachment|pelvic organ prolapse correction with laparoscopic sacralcolpopexy with no attachement of posterior mesh
15810973|NCT04358978|Procedure|laparoscopic sacral colpopexy with posterior mesh attachment|pelvic organ prolapse correction with laparoscopic sacralcolpopexy with the attachement of posterior mesh to vagina
15810974|NCT04358965|Drug|intravenous tranexamic acid|patients will be given a single bolus IV injection of 15 mg/kg of tranexamic acid (TXA) 20 minutes before surgical incision plus one vaginal placebo tablet 60 minutes before skin incision.
15810975|NCT04358965|Drug|vaginal misoprostol|patients will be given one vaginal misoprostol tablet (200 mcg) 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision
15810976|NCT04358965|Drug|placebo|patients will be given one vaginal placebo tablet 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision
15810977|NCT04358952|Diagnostic Test|Global Longitudinal Strain|Electrocardiogram with measure of the Global Longitudinal Strain to evaluate myocardiac dysfunction
15811249|NCT04356794|Other|Sham electroacupuncture|Sham EA is treated for 4 weeks, 3 times per week.
15810978|NCT04358939|Other|Prone decubitus|According to the tolerance, the objective is to spend as much time as possible, up to 16 hours and beyond in prone position every 24 hours. At least two sessions of at least 30 minutes each must be performed daily.
15810979|NCT04358926|Device|Hyperbaric oxygen therapy|8 sessions in 4 days of breathing 100% oxygen in 2.2 ATA. Each session is 60 minutes. 1 meter/minute compression/decompression
15810980|NCT04358913|Device|MR scan with the Alberta linac-MR P3 system|Single MR imaging session to develop and optimize the necessary MR sequences on the Alberta linac-MR P3 system to allow for MR-guided radiotherapy.
15810981|NCT04358887|Procedure|piezoelectric surgery|after flap reflection bone and root end cutting are done with piezoelectric surgical insert
15810982|NCT04358887|Procedure|conventional bur|after flap reflection bone and root end cutting are done with surgical bur
15810983|NCT04358874|Other|Medication reconciliation|Medicines currently being taken will be reviewed and compared to the medicines that were prescribed at discharge.
15810984|NCT04358874|Other|Blood Pressure Management|Blood pressure will be checked at follow-up visits and medicines will be adjusted if blood pressure is above target range (>160/100)
15810985|NCT04358861|Procedure|Nonsurgical Root canal therapy|After administration of LA and rubber dam isolation, acess cavity was prepared using carbide burs. Working length was determined using root ZX apex locator and was verified radiographically. Canal preparation was done with protaper gold rotary instruments. 5ml of 5.25% NaOCl was used as irrigant. After instrumentation , the canals were irrigated with 5.0 ml of 17% EDTA for 1minute followed by irrigation with 5.0 ml of 5.25% NaOCl. Canals were dried with absorbent paper points, filled with calcium hydroxide paste and access cavity was restored with IRM.At the recall appointment ; after one week,paste removal, copious irrigation was done with 5.25% NaOCl and canals were dried with paper points. Canals were obturated with Gutta-Percha and ZOE based sealer.
15810986|NCT04358861|Device|Dental operating microscope|Dental operating microscope; a high magnification and illumination device was used in experimental group for performing nonsurgical root canal therapy.
15810987|NCT04358848|Device|X-PLO2R|Portable Oxygen Concentrator (POC)
15810988|NCT04358835|Dietary Supplement|Ketogenic diet|4:1 ratio enteral ketogenic formula within 48 hours of intubation
15810989|NCT04358835|Other|standard of care|standard of care/supportive therapy
15810990|NCT04358822|Procedure|Delayed cord clamping|The umbilical cord will be clamped after specific time intervals
15810991|NCT04358809|Drug|Suspension of heat killed (autoclaved) Mycobacterium w|Suspension of heat killed (autoclaved) Mw along with Standard of care (SOC) treatment for COVID-19
15810992|NCT04358809|Other|Placebo|Placebo along with Standard of care (SOC) treatment for COVID-19
15810993|NCT04358796|Device|Hyperbaric oxygent treatment|Subjects will enter the oxygen chamber. ATA will be elevated to 2 ATA. They will breath 100% oxygen while solving cognitive tests designed to assess their cognitive capacities
15810994|NCT04358796|Device|Control hyperbaric oxygen treatment|Subjects will enter the oxygen chamber. ATA will be elevated to 1.2 ATA for a short while and the decreased back to 1 ATA. They will breath air while solving cognitive tests designed to assess their cognitive capacities
15810995|NCT04358783|Biological|Plasma|The plasma unit will be fractionated in 200 mL aliquots for storage at -80°C until use. After thawing, it shall be administered in a single 200 mL dose to subjects who are randomized to that arm.
15810996|NCT04358783|Other|Best Available Therapy|It shall include, but not be limited to, oxygen therapy by means of a nasal cannula; high-flow nasal cannula; invasive or non-invasive mechanical ventilation; intravenous hydration; antibiotic therapy; thrombus prophylaxis; pain and fever management.
15810997|NCT04358770|Drug|Clocortolone Pivalate|Cream, 0.1%
15810998|NCT04358757|Procedure|Elective cesarean delivery|scheduled cesarean delivery for maternal / obstetric indications
15810999|NCT04358731|Biological|NmCV-5|"The NmCV-5 is a fixed-combination available as the lyophilized powder containing meningococcal groups A and X polysaccharides conjugated to tetanus toxoid and meningococcal groups C, W and Y polysaccharides conjugated to CRM197 protein. The vaccine will be reconstituted with normal saline just prior to administration.
~The NmCV-5 lyophilized powder component contains sucrose, sodium citrate and trometamol as excipients. This component is presented as a freeze-dried powder in a single dose vial. No preservative or adjuvant is present in the vaccine.
~The normal saline diluent is a sterile clear colorless liquid in a single dose glass ampoule."
15811000|NCT04358731|Biological|Menactra|The control vaccine is the licensed meningococcal serogroups ACYW conjugate vaccine (Menactra), manufactured by Sanofi Pasteur Incorporated. Menactra is supplied as a single 0.5 mL dose formulated in sodium phosphate buffered isotonic sodium chloride solution to contain 4 mcg each of meningococcal A, C, Y, and W polysaccharides conjugated to approximately 48 mcg of diphtheria toxoid protein carrier. No preservative or adjuvant is added during manufacture.
15811001|NCT04358718|Procedure|general anesthesia|Patients will receive intraoperative and postoperative intravenous opioid-based analgesia for robot-assisted laparoscopic radical cystectomy.
15811002|NCT04358718|Procedure|general anesthesia combined with epidural analgesia|Patients will receive epidural ropivacaine-based analgesia for robot-assisted laparoscopic radical cystectomy.
15811003|NCT04358705|Other|Aim 1: Online survey|"This survey will evaluate perceptions of flavors on appeal, purchasing and risk perceptions of cigarillo products among young adult and adolescent cigarillo users. This survey will be used to inform survey design for further aims.
~As a proxy for biological verification of tobacco use status, data on brand, frequency, and pricing will be collected to confirm user status
~Participants will rate the role of flavor and report perceptions of product appeal, health risk, advertising exposure and use intentions. Participants will also complete purchase and substitution tasks."
15811004|NCT04358705|Behavioral|Eye Tracking Activity|The eye tracking activity consists of a single in-person eye tracking activity that will take place in a private office where the participant will be seated in a chair within a typical viewing distance from a computer monitor equipped with an infrared camera on the monitor to capture precise eye movements. Participants will have their gaze monitored continuously by the camera on the computer monitor while a randomized set of stimuli (product advertisements) are viewed (n=30) for 10 seconds per image. Following each advertisement, an on-screen closed response question will re-center the participant's gaze for standardization prior to the next image
15811124|NCT04357860|Drug|Sarilumab 400 MG/2.28 ML Subcutaneous Solution [KEVZARA]|Best available treatment up to 14 days plus Sarilumab 400 mg
15811005|NCT04358705|Other|Eye tracking survey|Participants will complete a survey using Qualtrics immediately after the eye tracking activity and one week following completion of the activity via email to measure recall of brand name, product flavors, perceptions of cigarillo harm, and tobacco use behaviors and intentions.
15811006|NCT04358705|Behavioral|Online Experimental Marketplace (ETM)|"Administered online via Qualtrics
~Participants are given an account balance for use during their assigned ETM based on their average weekly tobacco use calculated from previous interview. Participants will view all four price conditions and all four flavor conditions in random order for a total of 16 rounds
~Cigarillo price conditions: 1) market price 2) ½ market price 3) 2X market price 4) 4X market price
~Flavor condition: 1) flavored cigarillos and fruit-flavored disposable-cigarettes available 2) unflavored cigarillos and fruit-flavored ecigarettes available 3) flavored cigarillos and tobacco-flavored e-cigarettes available 4) unflavored cigarillos and tobacco-flavored e-cigarettes available.
~Participants will purchase cigarillos with their account balance. During all ETM conditions, constant-priced alternative tobacco products (smokeless tobacco, nicotine lozenges, nicotine gum, and the nicotine patch) will be available in addition to the cigarillos and e-cigarettes."
15811007|NCT04358705|Other|Aim 3 survey|"Consists of:
~A screener and demographic data collection.
~A tobacco product withdrawal scale
~Upon completion of the ETM, participants will be asked to respond to a quality assurance question regarding the conditions that varied. Participants will be shown a list of 8 possible conditions and must chose one of the three that varied in order to be eligible to receive compensation.
~The tobacco product withdrawal scale again
~Measurements of nicotine dependence and flavor preferences"
15811008|NCT04358705|Other|Cognitive Interviews|Cognitive Interviews will be done in-person, using Zoom, or over the phone. Interviews will be video or audio recorded. . The participant will be given a select section of the survey questions from Aim 1. The survey will be uploaded to Qualtrics to reflect the way that survey would be conducted in Aim 1. With the survey questions in front of the participant on the computer screen, research personnel will ask probing questions about each one of the survey questions. If the participant is not able to participate in person or via Zoom, they will be allowed to be interview over the phone with access to the Qualtrics survey or a paper form. If the participant is unable to access the internet, the participant will be read the questions by research personnel. The participant will provide feedback about the questions and walk the research personnel through their thought process for approaching each survey question.
15811009|NCT04358692|Device|Aixplorer Mach30|To measure myocardial stiffness by ShearWave elastography on not beating heart
15811010|NCT04358679|Other|Conventional Treatment|"Conventional Treatment:
~Deep breathing: 10-15 reps, twice a day (BD)
~Assisted coughing 10-15 reps, BD
~range of motion (ROM)+ stretching 10 reps, BD
~Tilt table standing"
15811011|NCT04358679|Other|Upper Limb ergometer training|Conventional Treatment + upper limb (UL) ergometry exercise UL ergometry exercise 15 to 20 mints , 2 times ,five days per week for 6 weeks.
15811012|NCT04358666|Procedure|surgery and focal radiosurgery of the surgical bed|hypofractionned radiosurgery of the lesion
15811013|NCT04358653|Other|fall prevention exercise program|The intervention protocol was starting with a 10 minute warm up (5 minutes circular walking combined with neck rotation in clockwise and counterclockwise fashion and 5 minutes upper and lower limp stretching exercises) and was followed by 30 minutes of exercises that were aiming to muscle strengthening, balance improvement and functionability enhancement. The muscle strengthening routine consisted of exercises both from standing and sitting position using an elastic band, heel and toe standing, upper limb strengthening using dumbbells. Balance training consisted of standing on one leg, shifting weight laterally from one foot to the other, staggered stance, side stepping. Functionalibility improvement was promoted through walking upstairs and downstairs, standing up from sitting to upright position. At the end a 5 minute cool down procedure was following consisting of circular walking, mild head movements and upper and lower body stretching.
15811014|NCT04358627|Drug|Dexmedetomidine Injectable Product|continuous intravenous infusion of dexmedetomidine
15811015|NCT04358614|Drug|Baricitinib 4 MG Oral Tablet|Baricitinib+antiviral therapy administration for 2 weeks
15811016|NCT04358601|Device|Triathlon PS Knee System with all-polyethylene tibial components|Primary Total Knee Replacement
15811017|NCT04358601|Device|Triathlon PS Knee System with metal-backed modular components|Primary Total Knee Replacement
15811018|NCT04358588|Drug|iNO (inhaled nitric oxide) delivered via the INOpulse Delivery System|Patients will be treated by means of an INOpulse device and cannula. The active study drug, nitric oxide for inhalation (iNO), will be provided in size 0.074 liter aluminum cartridge at a concentration of 6.0 mg/L (4880 ppm).
15811019|NCT04358575|Device|Triathlon CS Knee System with all-polyethylene tibial components|Primary Total Knee Replacement
15811020|NCT04358575|Device|Triathlon CS Knee System with metal-backed modular components|Primary Total Knee Replacement
15811021|NCT04358562|Drug|Gefitinib|If persistence of plasma ctDNA EGFRm after 8 weeks of gefitinib first-line treatment
15811022|NCT04358562|Drug|Anlotinib|If clearance of plasma ctDNA EGFRm after 8 weeks of gefitinib first-line treatment
15811023|NCT04358549|Drug|Favipiravir + Standard of Care|Favipiravir to be administered as an oral tablet or made into a slurry for subjects who cannot swallow tablets
15811024|NCT04358549|Drug|Standard of Care|Standard of Care
15811025|NCT04358536|Device|CovX|Convolutional neural network for classification of COVID-19 from chest X-rays
15811026|NCT04358523|Drug|ASC18|ASC18：ravidasvir and sofosbuvir fixed Dose Combination 200 mg/400 mg
15811027|NCT04358523|Drug|ravidasvir and sofosbuvir|RDV 200 mg and SOF 400 mg
15811028|NCT04358523|Drug|ASC18|ASC18：ravidasvir and sofosbuvir fixed Dose Combination 200 mg/400 mg
15811029|NCT04358510|Device|COViage|The COViage machine learning algorithm is designed to predict mortality in COVID-19, pneumonia and mechanically ventilated ICU patients.
15811030|NCT04358497|Device|Medtronic® Concerto® detachable coil system|coil embolization of the reflux pathways
15811031|NCT04358497|Procedure|sclerosis|Pelvic varices sclerosis with polidocanol foam
15811032|NCT04358497|Drug|Diosmin / Hesperidin|Best chronic medial treatment
15811033|NCT04358497|Drug|Ibuprofen 400 mg|NSAID treatment
15811125|NCT04357860|Drug|Best available treatment|Best available treatment up to 14 days
15811250|NCT04356755|Procedure|Adipose tissue harvest|An adipose tissue harvest (1) will be performed at D-14±1 for patient from arm ASC. Patients from placebo arm will have a sham adipose tissue harvest.
15811034|NCT04358484|Behavioral|Incredible Years - ASD and Language Delay®|"The IY - ASLD Program will consist of 22 weekly online group sessions for parents of children between 2-5 years of age with symptoms or a diagnosis of ASD or delayed language acquisition. The program will be conducted by a therapist and a co-therapist, trained in the model.
~Fidelity to the intervention will be assessed in accordance with the regulations of the program. All of the therapists and co-therapists will be trained in the intervention by accredited trainers. The three main therapists will be supervised by accredited supervisors of the IY Program, seeking accreditation in the intervention. As the intervention IY - ASLD has not been translated into Spanish, the English materials will be used with simultaneous translation into Spanish language."
15811035|NCT04358471|Biological|Intravitreal AAVCAGsCD59|AAVCAGsCD59 is administered as an intravitreal injection in the enrolled eye
15811036|NCT04358471|Other|Intravitreal Sham Injection|Sham injection mimics a real injection in the enrolled eye
15811037|NCT04358458|Drug|GEN3009|GEN3009 will be administered by intravenous (IV) infusions at various dose levels in 28-day cycles. Expansion cohorts will be treated at the Recommended Phase 2 Dose (RP2D).
15811038|NCT04358445|Other|Magnesium-Rich Artificial Cerebrospinal Fluid|The Magnesium-Rich Artificial Cerebrospinal Fluid (MACSF) is composed of several qualified clinical intravenous injections according to a specific formula, which has similar physical and chemical properties to physiological CSF. MACSF will be freshly made and used. It will be prepared by trained professionals on a specific workbench and sent to the operating room in a special container. Finally, it will be used in the operation by the neurosurgeons. Aseptic principles should be enforced strictly during the whole procedures, including preparation, transportation and application.
15811039|NCT04358432|Drug|AK102|Administered by subcutaneous injection
15811040|NCT04358432|Drug|Placebos|Administered by subcutaneous injection
15811041|NCT04358432|Drug|Statins and/or Ezetimibe|Lipid-lowering therapies
15811042|NCT04358419|Diagnostic Test|Aspergillus specific proteins in exhaled breath condensate (EBC)|The EBC will be collected by use of the RTube(R) system which is commercially available for the purpose of collection of EBC. As the patient breathes through a mouth piece, the exhaled breath is lead through a cooling chamber where the vaporous part of the exhaled breath condenses. The investigators aim at collecting a total minimum of 3.0 mL EBC per study participant in order to have sufficient amount of protein for the subsequent analysis.
15811043|NCT04358419|Diagnostic Test|Pneumocystis jirovecii DNA in exhaled breath condensate (EBC)|The EBC will be collected by use of the RTube(R) system which is commercially available for the purpose of collection of EBC. As the patient breathes through a mouth piece, the exhaled breath is lead through a cooling chamber where the vaporous part of the exhaled breath condenses. The investigators aim at collecting a total minimum of 3.0 mL EBC per study participant in order to have sufficient amount of protein for the subsequent analysis.
15811044|NCT04358406|Drug|Recombinant human plasma gelsolin (Rhu-pGSN)|Intravenous administration of rhu-pGSN at 12 mg/kg, 3 doses
15811045|NCT04358406|Other|Placebo|Normal saline in matched volume to treatment arm. Undistinguishable in syringe.
15811048|NCT04358380|Other|Liver injury|LFTs elevation or liver decompensation
15811049|NCT04358367|Drug|Dexmedetomidine Injectable Product|Spinal anesthesia and intravenous dexmedetomidine (1μg/kg). The administrated drugs were slowly injected intravenously over 10 minutes then intrathecal block was achieved using 2-2.2 ml of hyperbaric bupivacaine (10 -12.5 mg) introduced at L3/4 or L4/5 interspace.
15811050|NCT04358367|Drug|Saline|Spinal anesthesia and intravenous saline. The administrated drugs were slowly injected intravenously over 10 minutes then intrathecal block was achieved using 2-2.2 ml of hyperbaric bupivacaine (10 -12.5 mg) introduced at L3/4 or L4/5 interspace.
15811051|NCT04358354|Drug|Irinotecan|Irinotecan 150 mg/m2
15811052|NCT04358354|Drug|Oxaliplatin|Oxaliplatin 85 mg/m2
15811053|NCT04358354|Drug|5-fluorouracil|5-fluorouracil 400 mg/m2 iv bolus and 2400 mg/m2 civ 46 hours
15811054|NCT04358341|Drug|Irinotecan|150 mg/m2 ivdrip every 14 days
15811055|NCT04358341|Drug|DOXOrubicin Liposome Injection|25 mg/m2 ivdrip every 14 days
15811056|NCT04358341|Drug|5fluorouracil|400mg/m2 iv bolus and 2400 mg/m2 civ 46h every 14 days
15811057|NCT04358328|Other|Comprehensive geriatric assessment (CGA) and care|Comprehensive geriatric assessment and care including geriatric-, nursing-, physiotherapist-, and dietician assessments followed by appropriate interventions.
15811058|NCT04358328|Other|Standard care|Standard pre-, peri- and post operative care.
15811059|NCT04358315|Behavioral|Behavioral Intervention|Smell or puff e-liquids
15811060|NCT04358315|Other|Questionnaire Administration|Ancillary studies
15811061|NCT04358302|Behavioral|Pillsy|"The electronic pill bottle cap, Pillsy, and its accompanying software application provides reminders to take a scheduled dosage of medication via bottle cap alerts and smartphone push notifications, text messages, and/or automated phone calls. The Pillsy application records dosing dispense date and time when the user opens the bottle. During the first 2 weeks of the trial, the electronic notifications will be disabled to determine a baseline measure of adherence. Within 1 day after Visit 2, the electronic notifications will be turned on for all participants, resulting in a series of alerts (via electronic pill bottle cap alerts and smartphone push notifications, text message, and/or automated phone calls).
~The electronic pill bottle cap, Pillsy, is a commercially available device marketed to consumers. The electronic pill bottle cap does not capture or store PHI. Quick tips on how to use Pillsy can be found at https://www.pillsy.com/instructions"
15811062|NCT04358289|Other|Basic antimicrobial stewardship education|Commune health center: Revision of guidelines for antibiotic prescribing for respiratory infections in primary care, Training primary healthcare doctors in the application of the new guidelines
15811063|NCT04358289|Other|Participatory action research group in commune health center and community|"Establish a participatory action research group
~Engagement with the group through participatory action research involving problem identification, planning change strategies, implementing strategies, and evaluation"
15811126|NCT04357834|Other|Equipment with smartwatch throughout hospital stay on the general ward|Participants with confirmed SARS-CoV-2 infection or suspicion of COVID-19 will be equipped with a smartwatch and wear the device throughout the hospital stay on the general ward.
15811064|NCT04358289|Other|Antimicrobial stewardship program in hospitals|"The intervention activities in hospitals will include: training a health-worker in each of the participating hospitals to act as a facilitator or activator; forming an antibiotic stewardship group; meeting regularly and following an action-research cycle that includes problem identification, planning change strategies, implementing strategies, and evaluating strategies"
15811065|NCT04358289|Other|Community education|Development of educational materials for the community and farmers; Disseminated of messages through posters, leaflets and local media channels
15811066|NCT04358276|Other|Computer-Assisted Intervention|Complete online course
15811067|NCT04358276|Device|Dermatoscope|Receive dermatoscope
15811068|NCT04358276|Other|Educational Intervention|Receive study packet
15811069|NCT04358276|Other|Educational Intervention|Receive physician directed letter and educational package
15811070|NCT04358276|Other|Questionnaire Administration|Ancillary studies
15811071|NCT04358276|Other|Text Message|Receive text messages
15811072|NCT04358263|Device|Continuous Glucose Monitoring Guardian Connect Mobile system (real-time continuous glucose monitoring)|rtCGM and isCGM are used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.
15811073|NCT04358263|Device|Continuous Glucose Monitoring FreeStyle Libre Flash system (intermittently-scanned continuous glucose monitoring)|rtCGM and isCGM are used in Type 1 diabetic patients to improve glucose control and to minimize or avoid severe hypoglycaemia.
15811074|NCT04358250|Procedure|Direct Superior Approach|GROUP II :Patients positioned in lateral decubitus.landmark for incision is the apex of the greater trochanter,and skin, subcutaneous tissue except fascia are incised accordingly. Fibers of gluteus will be separated and not incised.posterior capsulotomy is performed,;femur is dislocated and neck osteotomy carried out, followed by preparation of femoral canal with progressive broach. Acetabulum is prepared with burs of increasing diameter, and acetabular cup is impacted. A polyethylene insert and a femoral rasp are subsequently introduced.All remaining definitive implants can be positioned.
15811075|NCT04358250|Procedure|posterolateral approach|GROUP I:patients are positioned in lateral decubitus.Landmark for incision is the apex of the greater trochanter.posterior capsulotomy is performed, femur is dislocated and neck osteotomy carried out, followed by preparation of femoral canal with progressive broach.Acetabulum is prepared with burs of increasing diameter,and acetabular cup is then impacted.All definitive implants can be positioned.
15811076|NCT04358237|Drug|Lurbinectedin|"Lurbinectedin will be presented as a lyophilized powder for concentrate for solution for infusion in 4-mg vials. Before use, the 4-mg vial will be reconstituted with 8 mL of sterile water for injection, to give a solution containing 0.5 mg/mL of PM01183. For administration to patients as IV infusion, reconstituted vials will be diluted with glucose 50 mg/mL (5%) or sodium chloride 9 mg/mL (0.9%) solution for infusion.
~PM01183 will be administered as a 1 hour IV infusion Q3W, in a minimum volume of 100 mL of solution for infusion (either 5% glucose or 0.9% sodium chloride), or a minimum volume of 250 mL if through a peripheral line, always at a fixed rate and through a pump device."
15811077|NCT04358237|Drug|Pembrolizumab|Pembrolizumab will be supplied as a solution for infusion in a single-use vial. Each vial contains 100 mg of MK3475 (pembrolizumab) in 4 ml of solution. Pembrolizumab 200 mg will be administered as a 30 minute IV infusion Q3W.
15811078|NCT04358224|Biological|Dupilumab Prefilled Syringe|open-label
15811079|NCT04358211|Biological|Biological: COVID-19 convalescent plasma|One unit of ABO compatible COVID-19 convalescent plasma
15811080|NCT04358198|Diagnostic Test|Artificial intelligence|The AI algorithm based on the convolutional neural network (CNN) will be used for analysis the pictures of gastric intestinal metaplasia and normal mucosa. Then AI will be used as a diagnostic tool for GIM during routine endoscopy by using pathology as a gold standard.
15811081|NCT04358185|Drug|Itacitinib (INCB039110)|Novel and small molecule selective inhibitor of JAK1
15811082|NCT04358172|Other|'Oral and Denture Guide' mobile application|'Oral and Denture Guide' mobile application provides evidence-based information about cleaning aids and material for dentures, denture care and oral hygiene instructions.
15811083|NCT04358159|Device|Ventralex|Repair of the hernia by a Ventralex patch in sublay position
15811084|NCT04358159|Device|Progrip|Repair of the hernia by a Progrip mesh in onlay position
15811085|NCT04358146|Other|Experimental Infant formula|Exclusive formula feeding with the new infant formula thickened with fibers
15811086|NCT04358146|Other|Infant formula thickened with locust bean gum|Exclusive formula feeding with the formula thickened with locust bean
15811087|NCT04358133|Drug|Chlorhydrate de morphine|The experimental group will receive an intravenous titration of morphine followed by a subcutaneous administration of morphine hydrochloride for 24 hours according to a predefined protocol
15811088|NCT04358133|Drug|NaCl 0,9%,|The control group will receive placebo NaCl 0.9% administered according to the same protocol as the experimental arm
15811089|NCT04358120|Device|Hyaluronic Acid Combined With Chondroitin Sulfate|"Subjects' participation in the study will last 26 weeks. The study includes 7 visits that consist of a Screening visit, three treatment visits and three follow-up visits.
~Eligible subjects will undergo a Baseline visit (V1 at week 0) during which, after the confirmation of eligibility, assessments and ultrasound evaluation, the study subjects will be treated with the 1st injection of 2%Hyaluronic Acid and 2% chondroitin sulfate Subsequent treatments will be administered at weekly intervals during Visit 2 (V2 at week 1) and Visit 3 (Visit 3 at week 2) after the effectiveness assessments.
~Study subjects will return for Follow-up visits 1 month (Visit 4 at week 6), 3 months (Visit 5 at week 14) and 6 months (Visit 6 at week 26) after the last injection"
15811090|NCT04358094|Other|Conversational hypnosis script|Conversational hypnosis during peripherical veinous catheter set up
15811091|NCT04358094|Other|Standard script|Standard script during peripherical veinous catheter set up
15811092|NCT04358081|Drug|HCQ|Hydroxychloroquine Monotherapy
15811093|NCT04358081|Drug|HCQ+AZT|Hydroxychloroquine with azithromycin
15811094|NCT04358081|Drug|Placebo|Placebo
15811309|NCT04356287|Biological|UCMSC|Each infusion will consist of 1 million MSC/kg suspended in 50 mL of PlasmaLyte A.
15811099|NCT04358055|Device|WET® gel|In each application, a puff should be administered in each nostril every two seconds, with minimal inspirations, up to a sensation of lubrication in the external conduct is perceived. Then the patient should proceed with short inspirations and light touching of ala of the nose, to favour the distribution of the gel. A maximum of 4 erogations (2/nostril) is allowed in each application session.
15811100|NCT04358042|Other|Brief Psychiatric Rating Scale|The Abbreviated Psychiatric Rating Scale is a clinical scale for measuring symptomatic change in psychiatric inpatients for various conditions. It includes an accurate and complete description of the major characteristic symptoms. It is based both on patient responses and on observations made during the interview by the clinician. The usual reference period is the last two weeks.
15811101|NCT04358042|Other|Depression, Anxiety and Stress Scale|"evaluation of 3 dimensions of psychological distress: depression, anxiety and stress. The scale consists of 21 items and the patient is instructed to choose for each item the one that best corresponds to his or her experience over the past week, on a scale of 0 (does not apply to me at all) to 3 (applies entirely to me, or the vast majority of the time). A score is calculated for each dimension according to a predefined rating."
15811102|NCT04358042|Other|Impact of Event Scale-Revised|is a 22-item self-questionnaire that measures perceived stress in reference to a traumatic event during the previous 7 days. Each item is rated on a scale ranging from 0 (not at all) to 4 (extremely) and 3 sub-scores of post-traumatic symptoms are calculated: Revivification, Avoidance, Psychophysiological Activation, as well as a total score of severity of the state of stress. Acute Stress Disorder (ASD) and Post-Traumatic Stress Disorder (PTSD) share the same symptoms, the former lasting between 3 days and one month, while the latter is diagnosed when symptoms persist beyond one month. Since the exposure to the stressful event will have occurred less than a month ago, this questionnaire here will help identify a state of acute stress. A total R-ESI score equal to or greater than 33 suggests a significant level of symptoms
15811103|NCT04358042|Other|Connor-Davidson Resilience Scale 10 items (CD-RISC 10)|"Self-questionnaire composed of 10 items, evaluating the resilience capacities of patients. Resilience may act as a moderator against the symptoms of PTSD. This instrument uses a 5-point Likert-type response scale ranging from 0 Not true at all to 4 True most of the time."
15811104|NCT04358016|Drug|Terlipressin|Evaluate the effect of Terlipression on the occurance of acute kidney injury in patients with upper-gastroentestinal bleeding
15811105|NCT04358016|Drug|Somatostatin|Somatostatin
15811106|NCT04358003|Device|Marker Therapeutics D2000 Cartridge (D2000) for use with the Spectra Optia® Apheresis System (Optia SPD Protocol)|"Subjects will receive one treatment per day with the D2000 Cartridge for up to 4 hours (treatment cycle) for up to seven (7) days. Treatment may extend beyond 7 days, up to 14 days total, if deemed necessary and useful by the principal investigator (PI). Additional cartridges may be used, if needed, to achieve the maximum daily treatment duration of 4 hours. Each day, before initiating the treatment cycle, pre-treatment chemistry and hematology, coagulation status, and disease severity scores (SOFA, APACHE II) will be collected. Then, immediately following the therapy on each treatment day, post-therapy measurements will also be collected.
~Study Exit. Subjects will be exited from the study after the Day 28 follow-up visit which will occur 28 days after Study Day 1. Subjects will be included in the study for a total of 28 days. Subjects may also choose to discontinue at any time or conclude participation at the discretion of the PI or the subject's treating physician."
15811107|NCT04357990|Device|Viruxal Oral and Nasal Spray|Viruxal Oral and Nasal Spray is a Class I CE marked medical device manufactured by Kerecis hf. The Device contains Omega3 Viruxide. The main components in Omega3 Viruxide are Neem oil and St. John's Wort oil. The Device is administered from a pressurized canister into the oral and nasal cavity, where it creates a physical barrier for temporary protection of the mucosal tissue.
15811108|NCT04357990|Other|Placebo|The placebo will be a similar spray containing saline only.
15811109|NCT04357977|Diagnostic Test|RBA-2|Collection of non-invasive in vivo saliva from confirmed cases of both infected and non-infected COVID-19 patients or site staff at the testing site and compare the test results using the RBA-2 against the standard test results used for diagnosis.
15811113|NCT04357938|Device|CT-imaging|Chest CT to rule out pneumonia in PCR negative, nonspecific symptomatic patients to prevent the spread of SARS-CoV-2 within the hospital.
15811114|NCT04357912|Behavioral|Activity Tracker Group|In addition to the standard of care exercise education, participants in the activity tracker group will be provided a Fitbit physical activity tracker at no cost to the participants. They will be asked to download the Fitbit application (app) to their personal smartphone device to allow them to see their own data collected by the Fitbit. They will also be asked to download the Stridekick app for the purpose of sharing their activity tracker data electronically with the study team and having the opportunity to participate in fitness challenges through the app. App accounts will be created by the participants with usernames that do not contain the participant's identifiable personal information. Optional fitness challenges will be created once per month by the study investigators, and participants will also receive a weekly message of encouragement from the study team.
15811115|NCT04357912|Behavioral|Standard of Care Group|Participants will receive standard of care exercise education.
15811116|NCT04357899|Drug|thrombolysis therapy|
15811117|NCT04357899|Procedure|endovascular therapy|
15811118|NCT04357899|Procedure|decompressive surgery|
15811119|NCT04357899|Diagnostic Test|multimodal imaging in acute ischemic stroke|
15811120|NCT04357899|Procedure|transfer of acute stroke patients to tertiary stroke centers|
15811121|NCT04357899|Drug|initiation of antiplatelets, oral anticoagulation and lipid lowering drugs for secondary prevention|
15811122|NCT04357873|Drug|pembrolizumab; vorinostat|"Pembrolizumab: 200 mg every 3 weeks, up to 35 administrations
~Vorinostat: 400 mg once daily, until progression"
15811123|NCT04357860|Drug|Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]|Best available treatment up to 14 days plus Sarilumab 200 mg
15811127|NCT04357821|Drug|Combination Intervention|"IL-12 adjuvanted p24CE DNA prime (p24CE/IL-12) at Weeks 0 and 4
~IL-12 adjuvanted DNA boost (p24CE plus p55gag) at Week 12
~MVA/HIV62B (MVA62B) boost at Week 20
~single dose of two bNAbs (VRC07-523LS and 10-1074, which target CD4 binding site and V3 loop, respectively) at week 24 with a TLR9 agonist (lefitolimod) administered weekly between Weeks 24 and 33 (10 doses)
~ATI with single dose of VRC07 and 10-1074 at Week 34"
15811128|NCT04357808|Drug|Sarilumab|Single dose treatment with sarilumab 2 x 200 mg subcutaneously
15811129|NCT04357808|Other|Standar of care|Usual clinical care
15811130|NCT04357795|Drug|CequaTM (Cyclosporine 0.09%) ophthalmic solution|One drop CequaTM (Cyclosporine 0.09%) ophthalmic solution in each eye twice daily, approximately 12 hours apart.
15811131|NCT04357782|Drug|L-ascorbic acid|50 mg/kg L-ascorbic acid infusion given every 6 hours for 4 days (16 total doses)
15811132|NCT04357769|Other|PSS (Perceived Stress Scale)|Self-administered scale for the evaluation of the stress perceived by the subject in the last weeks
15811133|NCT04357769|Other|GAD-7 (7-item Generalized Anxiety Disorder)|Self-administered scale for the evaluation of anxiety symptoms in the last weeks
15811134|NCT04357769|Other|PHQ-9 (9-item Patient Health Questionnaire)|Self-administered scale for the evaluation of depressive symptoms in the last weeks
15811135|NCT04357769|Other|SPEQ (Specific Psychotic Experiences Questionnaire) - Paranoia and Grandiosity Subscales|Self-administered scale for the evaluation of sub-threshold psychotic symptoms in the last weeks
15811136|NCT04357769|Other|Zaritt Burden Interview|Self-administered scale for the evaluation of severe mental disorder patients' caregiver burden
15811137|NCT04357756|Drug|YH001|YH001 will be administered intravenously every three weeks (Q3W) for 15 weeks (5 cycles) at doses of Dose A, Dose B, Dose C, Dose D, Dose E, Dose F and Dose G.
15811138|NCT04357756|Drug|Toripalimab|Toripalimab will be administered by intravenously (Q3W) by the fixed dose of 240 mg from the 2nd cycle to 5th cycle.
15811139|NCT04357743|Other|Chin supported Arm ergometry with pursed lip breathing|"The participants sat in chin support position for 10 minutes followed by arm ergometry with pursed lip breathing for 10 minutes. The participants again sat in chin support position for 10 minutes.
~The treatment was provided for one week"
15811140|NCT04357743|Other|Arm ergometry with pursed lip breathing|"The participants sat in normal position for 10 minutes followed by arm ergometry with pursed lip breathing for 10 minutes; the participants again sat in sitting position for 10 minutes.
~The treatment was provided for one week."
15811141|NCT04357730|Drug|Alteplase 50 MG [Activase]|Patients randomized to Alteplase-50 group will receive 50 mg of Alteplase intravenous bolus administration over 2 hours, given as a 10 mg push followed by the remaining 40 mgs over a total time of 2 hrs. Immediately following the Alteplase infusion, 5000 units (U) of unfractionated heparin (UFH) will be delivered and the heparin drip will be continued to maintain the activated partial thromboplastin time (aPTT) at 60-80sec (2.0 to 2.5 times the upper limit of normal). Re-bolusing of Alteplase, at the same dose, is permitted in the Alteplase-50 intervention group in those patients who show an initial transient response (>20% improvement of PaO2/FiO2 over pre-infusion of Alteplase at any of the measurements at 2, 6, 12 or 18 hours, but <50% improvement of PaO2/FiO2 at 24 hours after randomization); the repeat dose will be given between 24 and 36 hours after the initial Alteplase administration.
15811142|NCT04357730|Drug|Alteplase 50 MG [Activase]|wed by the remaining 40 mgs over a total time of 2 hrs. Immediately following this initial Alteplase infusion, we will initiate a drip of 2 mg/hr Alteplase over the ensuing 24 hours (total 48 mg infusion) accompanied by an infusion of 500 units per hour (U/hr) heparin during the Alteplase drip. After this, heparin dose will be increased slowly to maintain aPTT between 60 and 80 sec, titrated per attending's discretion.
15811143|NCT04357717|Diagnostic Test|ExoDx Prostate|Urine-based biomarker tool to support decision to biopsy in patients with PSA between 2-10ng/ml
15811144|NCT04357704|Other|S0N0|(no ITD)
15811145|NCT04357704|Other|S0N500|(ITD +500µs on noise)
15811146|NCT04357704|Other|S-500N500|(ITD -500µs on signal and +500 µs on noise)
15811147|NCT04357704|Other|S0N1000|(ITD + 1000 µs on noise)
15811148|NCT04357704|Other|S0Nuncorr|(no ITD cue, with uncorrelated stimulation frame)
15811149|NCT04357691|Behavioral|Conventional training|Participants will perform a conventional training for 4 weeks, using low-moderate-high-low intensity progression training model
15811150|NCT04357691|Behavioral|AI-led training|Participants will perform an AI-led training for 4 weeks
15811151|NCT04357678|Other|Qi Gong Programme|"Warm-up: In warm up session joint activities were performed along with light stretching. Patients performed these activities with instructor's commands for 5 minutes.
~Liu Zi Jue exercise: patients performed intact Liu Zi Jue exercise (form of Qigong).
~This includes six healing sounds, Xu, He, Hu, Si, Chui, Xi and the Harmonized actions along with the instructor for 20 minutes. Cooling-down: After completion of Qigong, patient done gentle stretching to adjust back their breathing and this cool down session lasted for 5 minutes. Subjects received supervised training session for 30 min twice a week."
15811152|NCT04357678|Other|Short Form Sun Style Tai Chi|"Commencing Movement, Opening and closing hand, Single whip, Waving hands in the cloud, Opening and closing hands, Brush knee, Playing lute, Perry and Punch, Block and close, Pushing the mountain, Closing movement.
~Participants attended two supervised 30min sessions twice a week. Participants learnt 3 to 4 forms per week and at the completion of study (which is the six week of training), they completed all 21 forms. In each training session, participants revised previous SSTC forms that they learnt earlier up to that session."
15811153|NCT04357665|Procedure|Bilateral TAPP Repair|laparoscopic transabdominal preperitoneal repair using 2 separate meshes fixed by laparoscopic tackers
15811154|NCT04357665|Procedure|Open PP Repair|Open pre-peritoneal repair using single mesh fixed by sutures
15811155|NCT04357665|Procedure|Bilateral Lichtenstein Repair|Bilateral Lichtenstein Repair using 2 separate meshes fixed by sutures
15811156|NCT04357639|Other|No intervention|No intervention: Usual care for nasopharyngeal sampling and blood sampling for COVID-19 detection
15811157|NCT04357626|Other|Inpatient Rehabilitation|Observational electronic records review study during inpatient rehabilitation
15811158|NCT04357613|Drug|Experimental drug|Imatinib 800mg/d during 14days
15811159|NCT04357600|Biological|Allogeneic Umbilical Cord Mesenchymal Stem Cell|All research samples will be treated by Intravenous injection of allogeneic mesenchymal stem cells and hemodynamic observation will be done for 24 hours after treated. Periodic post-treatment observation will be done on 1st month, 3rd month, and 6th month after therapy. The Independent variable in this research is Child-Pugh B Cirrhosis caused by Hepatitis B, while the dependent variable is the degree of liver function damage consisting of an examination of liver function, Child-Pugh score, and MELD score.
15811160|NCT04357587|Drug|Pembrolizumab|200 mg intravenously (IV) on days 1, 22, and 43
15811161|NCT04357587|Radiation|External beam radiation|Daily fractions of 200 cGy, 5 days a week for the first 5 weeks of the study, excluding weekends
15811162|NCT04357587|Drug|Capecitabine|825 mg/m2 orally twice a day on days where radiation therapy is given
15811163|NCT04357574|Other|Telehealth|patients have virtual visits with Radiation Oncology providers in lieu of in person clinic visits as a necessary response to COVID-19
15811164|NCT04357561|Behavioral|Exercise group (Schroth best practice)|Exercise program will be structured with scoliosis specific exercises (schroth best practice). Schroth best pratice is a pattern spesific scoliosis rehabilitation concept which aimes active self correction during curve pattern specific curve activities of daily life. Exercises for rotational breathing, everyday activities, spinal mobilization and corrective exercises will be specified based on the curve type and applied under the supervision of a physiotherapist.
15811165|NCT04357548|Device|FEEDBACK|Once the sample was selected, a test was performed in which the professionals performed 2 minutes of CPR on the dummy without any feedback system, after 5 minutes they performed 2 minutes of CPR with feedback system through the Zoll® monitor with CPR patch -D padz training, to later compare the pretest-posttest results.
15811166|NCT04357535|Drug|Angiotensin-Converting Enzyme Inhibitors (ACE-I) and Angiotensin II Receptor Blockers (ARB)|ACE-I and ARB are a class of blood pressure lowering medications used to manage hypertension.
15811167|NCT04357522|Biological|15-Valent Pneumococcal Conjugate Vaccine|4/1 dose(s) according to age of subjects. Single intramuscular dose contains 0.5ml 15-Valent Pneumococcal Conjugate Vaccine.
15811168|NCT04357522|Biological|13-Valent Pneumococcal Conjugate Vaccine|4/1 dose(s) according to age of subjects. Single intramuscular dose contains 0.5ml 15-Valent Pneumococcal Conjugate Vaccine.
15811169|NCT04357509|Biological|Super circulating tumor infiltrating lymphocytes(ScTIL)|"Peripheral blood mononuclear cells (PBMCs) are used for cell preparation. PD-1(programmed death 1) positive T cells are isolated from peripheral blood by blood cell apheresis method and transduced with lentivirus loaded with enhanced receptor and superamplification factor. The obtained ScTIL is used for one-time intravenous infusion."
15811170|NCT04357483|Drug|flowable thrombin containing collagen hemostat matrix|A 5 ml flowable hemostat matrix (CollaStat®) was applied to the stump or anastomosis site after pancreatectomy.
15811171|NCT04357483|Drug|thrombin coated L-dopa contained collagen patch|A 5x2.5cm sized thrombin coated L-dopa contained collagen patch (CollaSeal®) was applied to the stump or anastomosis site after pancreatectomy.
15811172|NCT04357470|Other|Hand Therapy|The patients were admitted to 12-weeks rehabilitation program and were called up once a week for follow-up appointments. Hand therapy continued as home program between 12th week and 6th month.
15811175|NCT04357444|Drug|1: ILT101|Subcutaneous injections, once-daily administration for 10 consecutive days.
15811176|NCT04357444|Drug|2: Placebo Comparator|placebo in Subcutaneous route
15811177|NCT04357431|Other|self-administered questionnaire|Data will be collected using Google online self-administered questionnaire disseminated in Arabic language
15811178|NCT04357418|Other|it is a survey|this interview can be carried out face to face or remotely.
15811179|NCT04357392|Drug|Prednisone|Prednisone 10mg, TID * 2 weeks, decreasing 5mg per week, continuous treatment for 8 weeks
15811181|NCT04357366|Drug|Anakinra|Treatment with 100mg Anakinra subcutaneously (sc) once daily for ten days
15811182|NCT04357353|Drug|Platelet rich plasma|PRP will be used in the experimental arm.
15811183|NCT04357353|Drug|Placebo Sham Injection|sham injection
15811184|NCT04357340|Other|Pulmonary Physiotherapy Techniques|Participants will receive pulmonary physiotherapy techniques in six session during three days (twice daily). Four distinguished interventions will be provided for the patients: 1) Chest expansion exercises (for prevention and treatment of potential atelectasis); 2) Techniques to Mobilize or loosen the pulmonary secretions (Active cycle breathing, Coughing techniques, Vibration and Postural drainage); 3) Hold breathing exercise (3 sets, 10 repetition) and; 4) Walking training (based on patient's tolerance until 6 minute).
15811185|NCT04357327|Diagnostic Test|rapid salivary test|a rapid salivary test to detect SARS-CoV-2 spike protein in saliva with a lateral flow immunoassay
15811186|NCT04357301|Device|Closed-loop vasopressor|The system will adjust the norepineprhine infusion rate based on a target SAP of 130 mmHg in 20 patients
15811187|NCT04357288|Other|Patient Decision Aid|The Patient Decision Aid (PDA) is an interactive website designed for use by a participant without the need of their clinician present. It provides information about the atrial fibrillation diagnosis, possible treatments, the effect of this diagnosis on daily life, and how to prepare for a discussion about medications with a clinician. Participants may interact with the website by inputting their health information into the stroke risk calculator or answering questions about their values, goals, thoughts, etc. that they would like to discuss with their clinician.
15811188|NCT04357288|Other|Encounter Decision Aid|The Encounter Decision Aid (EDA) is an interactive website designed for use by a participant and their clinician together. Together, the clinician and participant can go through the website together and input the participant's health information into the same stroke risk calculator also in the PDA. The EDA also provides information about the diagnosis of AF, living with this diagnosis, and possible treatments, and prompts discussion of how a participant's values affects these aspects of AF.
15811189|NCT04357275|Other|ICU treatment|ICU treatment according to standard of care
15811247|NCT04356807|Procedure|Massage|Soft massage with soft pressures in limbs, tactile stimulation and no motion.
15811248|NCT04356794|Other|Acupuncture needle with electrical stimulation|EA is treated for 4 weeks, 3 times per week.
15811190|NCT04357262|Other|StreaMD|Patients who are randomized to the intervention arm will be signed up for the automated text messaging program. Patients will receive automated text messages related to their surgery during the study period and can also ask questions through the text messages program, where automated messages will be sent based on the questions asked.
15811191|NCT04357223|Drug|extract from Angelica archangelica leaf|A standardized extract from Angelica archangelica leaf. Capsule, Twice Daily
15811192|NCT04357223|Drug|Placebo|Placebo
15811193|NCT04357210|Procedure|fistula tract excision and anal sphincter reconstruction|The primary fistulous tract was excised together with any secondary tracts or residual cavities. Then on of the reconstructive steps was performed
15811194|NCT04357197|Device|Closed-loop|The system will be tested to see if it can avoid hypotension
15811195|NCT04357184|Other|Blood flow restriction training|BFRT is done with 4 exercises with low load resistance of 30% 1 repetition maximum
15811196|NCT04357171|Procedure|Low anterior resection with protective loop ileostomy|Nerve-sparing paraaortic lymph node dissection is performed. The inferior mesenteric artery is divided at 1-2 cm from its origin from the aorta or right below left colic artery. Nerve-sparing total mesorectal excision is performed. Side-to-end sigmoido-rectal anastomosis is created. A loop defunctioning ileostomy is performed.
15811197|NCT04357171|Procedure|Low anterior resection with protective loop transverse colostomy|Nerve-sparing paraaortic lymph node dissection is performed. The inferior mesenteric artery is divided at 1-2 cm from its origin from the aorta or right below left colic artery. Nerve-sparing total mesorectal excision is performed. Side-to-end sigmoido-rectal anastomosis is created. A loop defunctioning transverse colostomy is performed.
15811198|NCT04357158|Device|AeonoseTM|All participants will be asked to breathe into an electronic nose (eNose, the AeonoseTM, The eNose Company, Zutphen, the Netherlands) for 5 minutes during the pre-colonoscopy intake and just prior to the procedure to assess reproducibility (with >2 weeks in between).
15811199|NCT04357145|Other|High Dosage Home Exercise Training|"By giving more exercise to the experimental group, exercise adherence, pain and functionality will be compared with the standard exercise group.
~3 times more reputation than control
~Exercise Program to be Applied (0-3 Weeks):
~Isometric knee extensor and adductor exercise
~Hamstring stretching exercise
~Terminal knee extension exercise
~Straight leg lifting exercise
~Exercise Program to be Applied (3-12 Weeks):
~Stepping exercise
~Sit up and stand up without support
~Active knee flexion exercise
~Moving forward exercise"
15811200|NCT04357145|Other|Standard Dosage Home Exercise Training|"5-6 standard reputations for all exercises
~Exercise Program to be Applied (0-3 Weeks):
~Isometric knee extensor and adductor exercise
~Hamstring stretching exercise
~Terminal knee extension exercise
~Straight leg lifting exercise
~Exercise Program to be Applied (3-12 Weeks):
~Stepping exercise
~Sit up and stand up without support
~Active knee flexion exercise
~Moving forward exercise"
15811201|NCT04357132|Other|VR-Biofeedback|Participants will be instructed to use the Mindful Aurora Application
15811202|NCT04357132|Other|VR-Distraction|Participants will be instructed to use one of four applications
15811203|NCT04357119|Procedure|One-anastomosis gastric bypass|"Laparoscopic single anastomosis gastric bypass is reported to be a safe alternative to LRYGB, showing comparable efficacy in weight reduction and resolution of metabolic complications with reduced surgical complications.
~The advantages with this technique as claimed by those speaking in favor of it are many: fewer sites for leakage and internal hernia, easier and faster to learn and perform, easy to reverse and revise, and with results at least comparable with the result following standard Roux-en-Y gastric bypass (RYGB).
~The length of the biliopancreatic limb in single anastomosis gastric bypass as reported by Rutledge is fixed 200 cm starting at the duodenojejunal junction, neglecting the length of the common limb.
~Because of deficient data regarding the effect of common limb length on the outcome of LSAGB, so a clinical trial shall add new knowledge regarding sufficient weight loss, rate of complications and the need for revision."
15811204|NCT04357106|Biological|Convalescent plasma|Convalescent plasma obtained by aphaeresis from recovered patients.
15811205|NCT04357093|Other|Grape seed extract mouthwash|Mouthwash 15% grape seed extract
15811206|NCT04357093|Other|Sodium fluoride mouthwash|Sodium fluoride mouthwash
15811207|NCT04357080|Procedure|Urethroplasty|Augmentation Anterior Urethroplasty Using Dorsal Onlay Buccal Mucosal Graft
15811208|NCT04357067|Device|Lingual brackets|A type of bracket that applied lingual surface of teeth.
15811209|NCT04357067|Device|Labial brackets|A type of bracket that applied labial surface of teeth.
15811210|NCT04357054|Diagnostic Test|Darwish test|Infertile women planned for combined laparoscopy and hysteroscopy as an integral part of infertility wok-up.
15811211|NCT04357028|Drug|Measles-Mumps-Rubella Vaccine|Measles mumps Rubella vaccine is a weak attenuated life vaccine
15811212|NCT04357028|Drug|Placebos|0.5 ml subcutaneous of saline will be injected in posterior triceps aspect of upper arm
15811213|NCT04357015|Drug|intravenous tranexamic acid|The tranexamic acid (TXA) group will receive a single bolus IV injection of 15 mg/kg of TXA 20 minutes before surgical incision
15811214|NCT04357015|Drug|intravenous carbetocin|The carbetocin group will receive a single bolus IV injection of 100 mcg of carbetocin 20 minutes before surgical incision
15811215|NCT04357015|Drug|placebo|the placebo group will be given a normal saline IV bolus 20 minutes before surgical incision
15811216|NCT04357002|Drug|intravenous tranexamic acid|patients will be given a single bolus IV injection of 15 mg/kg of tranexamic acid (TXA) 20 minutes before surgical incision plus one vaginal placebo tablet 60 minutes before skin incision.
15811217|NCT04357002|Drug|vaginal dinoprostone|patients will be given one vaginal dinoprostone tablet (3mg) 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision
15811218|NCT04357002|Drug|vaginal placebo|patients will be given one vaginal placebo tablet 60 minutes before skin incision and a normal saline IV bolus 20 minutes before surgical incision
15811220|NCT04356976|Device|Ventralex|Repair of hernia using Ventralex patch in sublay position
15811221|NCT04356976|Other|Stratafix|Repair of hernia without mesh. Defect closed with Stratafix suture.
15811225|NCT04356950|Other|Thrombin generation test assay|lag time, initial velocity, time-to-peak, thrombin peak, total thrombin generation time, extrinsic thrombin potential (ETP). Crude quantitative values and relative values (%, by reference to the one obtained with an invariant reference plasma). Both without the addition of purified thrombomodulin (TM-) and with the addition of purified thrombomodulin (TM+). The ability of TM to inhibit thrombin generation will be calculated as follows: [ETP (%)(TM+) / ETP (%)(TM-)].
15811226|NCT04356950|Other|Fibrin generation markers assays|D-dimers (coagulation plus fibrinolysis), soluble fibrin monomers (coagulation only)
15811227|NCT04356937|Drug|Tocilizumab|"Patients will receive the standard treatment for COVID-19 per MGH guidance and also be randomized (2:1) to one of the following arms:
~Tocilizumab 8mg x 1 (n=185)
~Standard of care/Placebo (n=93)"
15811228|NCT04356937|Drug|Placebos|"Patients will receive the standard treatment for COVID-19 per MGH guidance and also be randomized (2:1) to one of the following arms:
~Tocilizumab 8mg x 1 (n=185)
~Standard of care/Placebo (n=93)"
15811229|NCT04356924|Behavioral|Psychological treatment|The treatment is an adjusted (to the cognitively impaired individual) combination of CBT, ACT, validation strategies, and psychoeducation. One focus is to increase motivation to lifestyle changes, and to a larger degree live life in correspondence with internal goals.
15811230|NCT04356924|Behavioral|Cognitive training|Computer based training tasks implemented with adaptive intensity. The cognitive training method that will be used is mainly related to executive control (i.e., ability to coordinate thoughts and actions in accordance with internal goals).
15811231|NCT04356911|Other|PLACEBO (Negative Control)|"The group received in-office bleaching. A 45-minute application of 35% hydrogen peroxide gel (Whiteness HP, FGM, Joinville, SC) was carried. After whitening therapy, a water-soluble placebo gel (KY®, Johnson & Johnson, SP, Brazil) was applied to the buccal surfaces of incisors, canines and premolars with the help of a Microbrush applicator (Microbrush, 3M ESPE, São Paulo , Brazil) for 10 minutes. Then, a rubber cup (Unid Microdont, São Paulo, SP, Brazil) mounted on a handpiece at low speed (Dabi Atlante, Ribeirão Preto, SO, Brazil) was used to rub the placebo gel for 20 seconds in each tooth surface. After washing the placebo gel, the laser tip was positioned at two points, apical and cervical, without emitting light (placebo), simulating the application of low-level laser therapy (LLLT).
~This protocol was performed in 3 sessions, with an interval of seven days between them."
15811232|NCT04356911|Other|FBM|This group received photobimodulation with low level laser therapy (LLLT) of infrared spectrum with a wavelength of 808 nm in its active environment AsGaAl (Photon Lase III, DMC Equipamentos Ltda; São Carlos, SP, Brazil), at two points: cervical and apical region of the incisors, canines and premolars. 60 J / cm² was applied at each point for 16 seconds. The laser was applied in 3 sessions with a time interval of seven days between them.
15811233|NCT04356911|Other|ESTRÔNCIO|After whitening therapy, a toothpaste with 10% strontium chloride (Sensodyne Original, GSK, London, United Kingdom) was applied to the buccal surfaces of incisors, canines and premolars with the help of a Microbrush applicator (Microbrush, 3M ESPE, São Paulo , Brazil) for 10 minutes. Then, a rubber cup (Unid Microdont, São Paulo, SP, Brazil) mounted on a handpiece at low speed (Dabi Atlante, Ribeirão Preto, SO, Brazil) was used to rub the desensitizer for 20 seconds on each tooth , according to the manufacturer's specifications. The desensitizer therapy was realized in 3 sessions with a time interval of seven days between them.
15811234|NCT04356911|Other|FBM+ESTRÔNCIO|After whitening therapy, a 10% strontium chloride toothpaste (Sensodyne Original, GSK, London, United Kingdom) was applied to the buccal surfaces of whitened teeth with the help of a Microbrush applicator applicator (Microbrush, 3M ESPE, São Paulo , Brazil) for 10 minutes. Then, a rubber cup (Unid Microdont, São Paulo, SP, Brazil) mounted on a handpiece at low speed (Dabi Atlante, Ribeirão Preto, SO, Brazil) was used to rub the desensitizer for 20 seconds on each tooth , according to the manufacturer's specifications. After washing the desensitizer, the photobimodulation was realized with Low Level Laser Therapy (LLLT) of infrared spectrum with wavelength of 808 nm in its active environment AsGaAl (Photon Lase III, DMC Equipamentos Ltda; São Carlos, SP, Brazil), in two points: cervical and apical region of the incisors, canines and premolars. 60 J / cm² was applied at each point for 16 seconds. This protocol was performed in 3 sessions, with an interval of seven days between them.
15811235|NCT04356898|Other|No intervention|No intervention
15811236|NCT04356872|Drug|Sintilimab|immune check point inhibitor, 200mg, iv, d1
15811237|NCT04356872|Drug|Doxorubicin Hydrochloride|ADM, 60mg/m2, iv, d1
15811238|NCT04356872|Drug|Ifosfamide|IFO, 1.8 g/m2/d, d1-5
15811239|NCT04356859|Drug|Albumin Human|Addition of albumin during acute resuscitation following burn injury
15811240|NCT04356846|Drug|LP-108 tablet|Taken orally within 30 minutes after a meal at the designated dose, once daily.
15811241|NCT04356833|Drug|nebulised recombinant tissue-Plasminogen Activator (rt-PA) - Cohort 1|Patients in the cohort 1 rt-PA group will receive the first dose as soon as possible after registration. 10mg rt-PA in 5mL diluent will be administered by nebulisation every 6 hours for 14 days, resulting in a total daily dose of 40mg.
15811242|NCT04356833|Drug|nebulised recombinant tissue-Plasminogen Activator (rt-PA) - Cohort 2 IMV|Patients on IMV will receive 60mg daily over three doses for 14 days
15811243|NCT04356833|Drug|nebulised recombinant tissue-Plasminogen Activator (rt-PA) - Cohort 2 NIV|NIV patients will receive 60mg daily for over 3 doses for two days, followed by 12 days receiving 40mg daily over two doses.
15811244|NCT04356820|Other|acupressure|Data collection took about 10 to 15 minutes. Then the woman invited to the examination room was asked to pull one of the envelopes with the names of the groups. The women who pulled the acupressure envelope were given a semi-sitting position where the acupressure application can feel comfortable and the researcher can easily apply the acupressure points. Before the acupressure application, massage was applied for 30 seconds to ensure circulation. Afterwards, 90 seconds consecutive pressures were applied to the specified acupressure points in a certain order (SP 6, Li 4), taking into account the direction of the meridian. After the examination, the pain formed during the gynecological examination was evaluated by applying the Short Form-McGill Pain Questionnaire without leaving the examination room
15811245|NCT04356807|Procedure|Reflex Locomotion Therapy|The exercises corresponding to the motor complexes of the 1st phase of the rolling reflex and the original creeping reflex were performed, dedicating one minute to each side and performing two repetitions in each session.
15811246|NCT04356807|Procedure|Passive Joint Mobilizations|Passive Joint Mobilizations with articular pressure described by Moyer-Mileur, et al. 1995 and modified by Vignochi, et al. 2008
15811251|NCT04356755|Drug|Autologous ASC|At day 0, patients will have ASC injections(3) in their ischemic DU. Patients will be followed-up for 16 weeks
15811252|NCT04356755|Drug|Placebo|At day 0, patients will have placebo injections(3) in their ischemic DU. Patients will be followed-up for 16 weeks
15811253|NCT04356742|Drug|Dapagliflozin 10mg|Dapagliflozin 10mg, orally, once daily, up to 24weeks
15811254|NCT04356742|Drug|Placebo|Dapagliflozin Placebo, orally, once daily, up to 24weeks
15811255|NCT04356742|Drug|Evogliptin 5mg|Evogliptin 5mg, orally, once daily for background therapy
15811256|NCT04356742|Drug|Metformin≥1000mg|Metformin≥1000mg, orally, daily for background therapy
15811257|NCT04356729|Drug|Atezolizumab|Atezolizumab will be administered intravenously at a fixed predetermined dose every three weeks ith 21 consecutive days defined as a treatment cycle.
15811258|NCT04356729|Drug|Bevacizumab|Bevacizumab will be administered intravenously at a fixed predetermined dose every three weeks, with 21 consecutive days defined as a treatment cycle.
15811259|NCT04356716|Drug|Sildenafil|Initial Sildenafil dosage will be weight dependent. Participants will start at 40 mg daily (20mg in the morning, 20 mg in the evening) or 60 mg daily (40mg in the morning and 20 mg in the evening). Sildenafil dosage may be increased to up to 80mg daily (20-40mg in the morning and 20-40mg in the evening) based on the response to lower doses. If the participant has not had improvement after initial treatment, the dose may be increased, at the discretion of the study physician.
15811260|NCT04356716|Other|Standard of Care Sildenafil|Medical record review of participants that receive Sildenafil as part of standard of care.
15811261|NCT04356716|Diagnostic Test|Ocular Coherence Tomography-Angiography (OCT-A)|Retinal photographs will be taken at each study visit.
15811262|NCT04356716|Other|Visual Acuity (VA)|Visual acuity will be measured with Snellen Eye Chart at each study visit.
15811263|NCT04356703|Other|Neuropsicomotor developmental test|Children will be evaluated trough Bayley III and PEDI scale. They also will be examined by pediatrician, neurosurgeon, orthopedics and phisiatry
15811264|NCT04356690|Drug|Etoposide|Etoposide 150 mg/m2 administered intravenously once daily on Days 1 and 4. If the treating clinicians feel that the patient initially benefited from etoposide but then has evidence of relapse of cytokine storm, the patient may continue on the standard HLH etoposide schedule of day 8, 11, 18, 25 after discussion with one of the study investigators.
15811265|NCT04356677|Drug|50 mg/mL Virazole|50 mg/mL Virazole aerosolized and administered over 1 hour twice a day for up to 6 days.
15811266|NCT04356677|Drug|100 mg/mL Virazole|100 mg/mL Virazole aerosolized and administered over 30 minutes twice a day for up to 6 days.
15811267|NCT04356664|Drug|GnRH agonist|One or two intramuscular injections of Decapeptyl 3 mg
15811268|NCT04356651|Procedure|Fu's subcutaneous needling(FSN)|In this study, physician will use a disposable Fu's subcutaneous needling(FSN) to penetrate the subject's skin from anterior superior iliac spine(ASIS) to 1/3 superior border of patella. Then the physician will push forward the needle parallel to the skin surface. The physician will sway the needle 45 times in 30 seconds. After swaying the needle, the physician will instruct the subject to do sole dorsiflexion for 10 seconds resisting the physician's opposite force, then the subject take a rest for 10 seconds. The above actions are 3 repetitions. Then the subject do knee flexion and extension for 10 seconds, and take a rest for 10 seconds. These actions are also 3 repetitions. After the above reperfusion approach of muscles, the physician will take out the needle to finish the treatment.
15811269|NCT04356651|Procedure|Transcutaneous Electric Nerve Stimulation|Transcutaneous electrical nerve stimulation (TENSor TNS) is the use of electric current produced by a device to stimulate the nerves for therapeutic purposes. TENS, by definition, covers the complete range of transcutaneously applied currents used for nerve excitation although the term is often used with a more restrictive intent, namely to describe the kind of pulses produced by portable stimulators used to treat pain. The unit is usually connected to the skin using two or more electrodes. A typical battery operated TENS unit is able to modulate pulse width,frequency and intensity. Generally TENS is applied at high frequency (>50 Hz) with an intensity below motor contraction (sensory intensity) or low frequency (<10Hz) with an intensity that produces motor contraction.
15811270|NCT04356638|Drug|Midazolam|Oral Midazolam and intranasal placebo
15811271|NCT04356638|Drug|Dexmedetomidine|Intranasal Dexmedetomidine and oral placebo
15811272|NCT04356638|Other|Placebo|Placebo orally and intranasally
15811273|NCT04356625|Diagnostic Test|MEPic|"patient in the supine position sitting 45° to 60°,
~closed suction catheter was removed
~a 90° elbow was placed and a bacterial filter in series with endotracheal tube
~adapter was also coupled to the aneroid pressure gauge
~in series an inspiratory unidirectional valve was placed that did not allow expiration
~2 ml of physiological solution was slowly instilled through the port in the 90º elbow to cause induced cough"
15811274|NCT04356612|Other|Chart Review|This is a retrospective chart review to determine the etiologies contributing to prolonged PACU discharge at a major Orthopedic Ambulatory Surgical Center.
15811275|NCT04356599|Other|Early dynamic 18F-FDG PET/CT assessment of cerebral glucose uptake|The intervention will consist in a dynamic cerebral 18F-FDG PET study performed at D2+/-1. Kinetic modeling will be performed using in-house software at the global, regional, and voxel level. In addition, cerebral perfusion and blood-brain-barrier permeability will be assessed at D4+/- 1 using perfusion MRI and permeability MRI.
15811276|NCT04356573|Other|fresh kiwifruit|Subjects ate 2 peeled kiwifruit with their midday meal for 2 weeks prior to testing.
15811277|NCT04356560|Diagnostic Test|COVID-19 test, polymerase chain reaction for SARS-CoV-2|surveillance
15811278|NCT04356547|Device|Fiberoptic intubation with laryngeal mask AuraGain|Participants should perform an fiberoptic tracheal intubation through the AuraGain laryngeal mask, in a pediatric simulator.
15811279|NCT04356547|Device|Fiberoptic intubation without laryngeal mask|Participants should perform an fiberoptic tracheal intubation without laryngeal mask, in a pediatric simulator.
15811282|NCT04356521|Procedure|Lateral Sagittal Approach|The US probe will be located medial to the coracoid process in the sagittal plane in the infraclavicular region, and then three cords of the brachial plexus will be viewed. Using the in-plane technique, bupivacaine 0.5% will be administered around the posterior cord (7ml), lateral cord (7ml), and medial cord (6ml).
15811283|NCT04356521|Procedure|Costoclavicular Approach|The US probe will be placed parallel to the clavicle in the midclavicular area and tilted toward the cephalad and the axillary artery, and three cords will be viewed. A needle will be forwarded from lateral to medial with the in-plane technique, and 20 ml of bupivacaine 0.5% will be administered at the center of the three cords.
15811284|NCT04356508|Drug|Nivolumab|Single dose at 0.3mg/kg
15811285|NCT04356495|Dietary Supplement|Vitamins|2 tablets daily from the first day (day 0) to day 9
15811286|NCT04356495|Drug|Telmisartan|1 tablet daily from the first day (day 0) to day 9
15811287|NCT04356495|Drug|Ciclesonide|2 puffs twice a day in an inhalation chamber from the first day (day 0) to day 9
15811288|NCT04356495|Drug|interferon β-1b|A 10-minute nebulization, once a day, from the first day (day 0) to day 4, of 9.6 MIU / 300 µg of IFN-β-1b (EXTAVIA®) diluted in 2 mL of water
15811289|NCT04356482|Biological|convalescent plasma|"In phase 1, different amounts of convalescent plasma will be evaluated depending on the severity of the case.
~In phase 2, both clinical, laboratory, imaging and viral presence (effectiveness) and safety will be evaluated."
15811290|NCT04356469|Biological|Haploidentical Hematopoietic Cell Transplantation|TCR alpha beta T-cell and CD19 B-cell depleted haploidentical transplantation
15811291|NCT04356456|Dietary Supplement|Lumenato|tomato oleoresin obtained from yellow dry tomato pulp
15811292|NCT04356443|Device|AirGo Respiratory Monitor|AirGo™ is composed of a wearable, miniaturized recorder unit and a medical grade Holter worn over the floating ribs of patients both at rest and during normal activity. The recorder measures live circumference changes.
15811293|NCT04356430|Drug|Abiraterone Acetate|1000 mg orally daily for 24 weeks before robotic assisted radical prostatectomy
15811294|NCT04356430|Drug|Prednisone|5 mg oral low dose prednisone, once daily
15811295|NCT04356430|Drug|Goserelin 10.8 mg|10.8 mg goserelin hypodermic once per 12 weeks
15811296|NCT04356417|Other|- Synthetic anti-malarial drugs|Prevalent users will be those with at least one dispensing of AMD or ARBs/ACEi's from 01/01/2019 to 01/01/2020. Exposed users will be those among prevalent users who still received AMD or ARBs/ACEi's on 31/12/2019. The inclusion period will be from 01/01/2019 to 01/01/2020. The study end date will be 30/06/2020. For each treatment AMD or ARB/ACRi's, the persistence of treatment will be defined as the length of time from initiation to discontinuation. Initiation will be the date of the first reimbursement of AMD or ARB/ACRi's during the inclusion period. We will define the discontinuation of treatment as a period of more than 90 days without fulfilment of a prescription for the same treatment after the period covered by the previous prescription i.e 30 days. Exposure to a combination of drugs will be defined as a period shorter than 30 days between the prescription of two different systemic drugs and the fulfilment of another prescription for both drugs in the following 90 days.
15811297|NCT04356391|Procedure|Connective Tissue Graft Technique|For the sites receiving the control technique (Connective Tissue Graft), the technique described by Langer B. and Langer L. will be started with a sulcular incision followed by a partial thickness flap. A CTG is then harvested according to the technique described by Bruno, the first incision is perpendicular to the 2nd premolar and 1st molar and is 2-3mm apical to their gingival margin as wide as the recipient site, followed by a second incision parallel to the for mentioned teeth, 1-2mm apical to the first incision, then the CTG is raised by periosteal elevator and released from apical and lateral attachments by sharp incision when needed. The graft is then prepared to have a homogenous thickness of 1.5-2mm. The donor CTG is stabilized to the underlying connective tissue interproximally using 4-0 Vicryl sutures. The recipient flap is repositioned coronally, to cover as much as possible of the graft with no tension, 2mm coronal to the CEJ, then sutured with 4-0 Vicryl sutures.
15811298|NCT04356391|Procedure|Pinhole Surgical Technique|For the sites receiving the test technique (Chao Pinhole Surgical Technique) the surgery starts with a small pinhole opening in the alveolar mucosa apical to the mucogingival junction of the affected tooth, the flap is then undermined using special instruments to create a full thickness pouch, followed by extending the pouch horizontally and coronally to undermined the adjacent papilla without incising it and free the flap for its coronal displacement. Then multiple 2x12mm strips of collagen resorbable membrane material (Bio-Gide, Geistlich Pharma AG) are packed under the papilla to secure the flap in a coronal direction. Gentle pressure is applied for 5 minutes to minimize the thickness of the blood clot after each of the procedures. The patients are advised to brush all teeth and sites except the buccal surfaces of the operated-on teeth, which are to be cleaned with 0.12% Chlorhexidine mouth rinse.
15811299|NCT04356378|Other|Data record|Data record
15811300|NCT04356365|Other|Cross-sectional study investigating the association of NPIs with mental health|Cross-sectional study investigating the association of NPIs with mental health
15811301|NCT04356352|Drug|Lidocaine|1 mg/kg lidocaine to a max of 100 mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
15811302|NCT04356352|Drug|Esmolol|0.5 mg/kg esmolol to a max of 50mg administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
15811303|NCT04356352|Other|Placebo|saline water administered approximately 30 seconds prior to the administration of propofol, with pain score obtained before the propofol is administered.
15811305|NCT04356326|Drug|Aspirin 150 mg|Treatment assigned by randomization will be prescribed immediately and continued throughout pregnancy up to 35 weeks + 6 days for both groups. The active or placebo will be dispensed by the centre's pharmacy. Treatment will be taken in the evening. A daily log is given to patients and must be completed every day.
15811306|NCT04356326|Drug|Placebo|Treatment assigned by randomization will be prescribed immediately and continued throughout pregnancy up to 35 weeks + 6 days for both groups. The active or placebo will be dispensed by the centre's pharmacy. Treatment will be taken in the evening. A daily log is given to patients and must be completed every day.
15811307|NCT04356313|Device|GORE® EXCLUDER® Iliac Branch Endoprosthesis|Compare between patients where Gore Excluder Iliac Branch Endoprosthesis and the Hipogastric component can be used with the group where the Hipogastric component can't be used for anatomical issues and a Gore Viabahn VBX is used instead of the Hipogastric component
15811308|NCT04356300|Biological|Exosome of MSC|Exosome of MSC at a dose of 150mg will be given intravenously to patients once a day for 14 times.
15811310|NCT04356287|Other|Placebo|Each infusion will consist of 50 mL of PlasmaLyte A.
15811311|NCT04356274|Other|Participatory System Dynamics (PSD)|Participatory system dynamics is a facilitated health care quality improvement or evidence-based practice implementation strategy that includes frontline addiction and mental health staff running simulations of clinic improvement strategies to find the best approaches for improving the reach of evidence-based psychotherapy and evidence-based pharmacotherapy.
15811312|NCT04356274|Other|Audit and Feedback (AF)|Audit and feedback is a health care quality improvement or evidence-based practice implementation strategy that includes frontline addiction and mental health staff reviewing clinical care team data to find the best approaches for improving the reach of evidence-based psychotherapy and evidence-based pharmacotherapy.
15811313|NCT04356261|Behavioral|Gamified Personalized Normative Feedback|Each week, all players will answer 3 questions of interest about first-year students' attitudes and behaviors (e.g., drinking, partying, exercising, studying, dorm life, etc.) generated by the student players. They will also guess how the typical same-sex student at their University answered the same questions and wager points on how close to the correct answer (group norm) each of their guesses is. Further, they will rate (e.g., thumbs up/thumbs down) the reported behaviors of other players and, then, submit and vote on questions for subsequent rounds. At the end of each week, players will receive enhanced personalized normative feedback feedback on two of the three questions, and receive feedback on how other students rated the answer they reported (preferred-sex injunctive norms).
15811314|NCT04356248|Behavioral|Endurance Training|Treatment in both arms consists of specific endurance exercise modalities (HIIT or ST). Treatments differ in the applied training intensities. Participants in both arms will exercise 3 times per week over a period of 3 weeks on a bicycle ergometer. Exercise sessions will be supervised by a trained physical therapist. Exercise intensity will be heart rate monitored based on the maximum heart rate (HRmax) assessed during the initial cardiopulmonary exercise test. Exercise sessions in both arms will include a warm-up and a cool-down period at low intensity (50% HRmax) for 3 min each.
15811315|NCT04356248|Behavioral|Education|Treatment in both arms consists of specific energy management education interventions (IEME or PMR). Treatments differ in the applied education approaches. Participants in both arms will exercise 2 times per week over a period of 3 weeks.
15811316|NCT04356235|Procedure|A: expander-silicone implant exchange and contralateral symmetrization with mastopexy and if needed with volume reduction|expander-silicone implant exchange and contralateral symmetrization with mastopexy and if needed with volume reduction
15811317|NCT04356235|Procedure|B: expander-silicone implant exchange with contralateral symmetrization with mastopexy and Ultrapro sling|expander-silicone implant exchange with contralateral symmetrization with mastopexy and Ultrapro sling
15811318|NCT04356235|Procedure|C: expander-silicone implant exchange and contralateral symmetrization with mastopexy and silicone implant augmentation|expander-silicone implant exchange and contralateral symmetrization with mastopexy and silicone implant augmentation
15811319|NCT04356235|Procedure|D: expander-silicone implant exchange and contralateral symmetrization with mastopexy and Utrapro sling and silicone implant augmentation|expander-silicone implant exchange and contralateral symmetrization with mastopexy and Utrapro sling and silicone implant augmentation
15811320|NCT04356235|Procedure|E: unilateral simple mastectomy|unilateral simple mastectomy
15811321|NCT04356235|Procedure|F: after bilateral SSM, ASM, NSM, expander-implant exchange|after bilateral SSM, ASM, NSM, expander-implant exchange
15811322|NCT04356222|Drug|Durvalumab|Intravenous infusion once every two weeks ,once 10mg/kg.
15811323|NCT04356222|Drug|methotrexate|Intrathecal chemotherapy specified dose on specified days
15811324|NCT04356209|Other|e-PRO Intervention|"Statements of symptoms and patients' health status (PROs) will be collected via a web interface, including access and use in patients with burden symptoms.
~The platform will include four items concerning 7 side effects of fibrosis of grade > 2 in breast cancer. Patients will be encouraged to evaluate on a 5-point Likert scale the frequency, the intensity and the repercussions on the daily life of some symptoms during the last 7 days, in particular on:
~general pain
~anxiety
~sadness
~texture of the treated breast
~Patients will also be invited to express themselves on the severity of two other symptoms of their choice, to their worst degree, by listing and rating them on a 5-point scale ranging from None to Very severe Finally, the aesthetic impact will be evaluated by patients on a visual analogue scale (VAS) of 0 to 100mm"
15811325|NCT04356209|Drug|Pravastatin|All patients will take Pravastatin 40 mg per day (From Day 0 to Month 12).
15811326|NCT04356196|Drug|Verapamil|Verapamil is a phenylalkylamine calcium channel blocker used in the treatment of high blood pressure, heart arrhythmias, and angina
15811327|NCT04356196|Drug|Bisoprolol|Bisoprolol is a cardioselective β1-adrenergic blocking agent used to treat high blood pressure.
15811328|NCT04356196|Drug|Placebo oral tablet|Placebo oral tablet
15811329|NCT04356183|Other|SWET: Supervised Weight loss and Exercise Training|Weight loss will occur via a dietitian-led intervention targeting weight loss over 16 weeks, with weekly weigh-ins and group support sessions. Exercise training will consist of three times per week of an interval-based aerobic program plus twice-weekly resistance training. Both weight loss and exercise training will be supervised to maximize safety and adherence.
15811330|NCT04356183|Other|CHAT: Counseling Health As Treatment|Control Arm over 16 weeks.
15811331|NCT04356170|Drug|Docetaxel|Docetaxel 75 mg/m² administered at D1 of each cure, every 3 weeks by intravenous infusion in 1 hour
15811332|NCT04356170|Drug|Cisplatin|cisplatine 75 mg/m² administered at D1 of each cure, every 3 weeks by intravenous infusion in 1 hour
15811333|NCT04356170|Drug|Fluoro Uracil|750 mg/m²/j administered continuously at D1 to D5 of each cure, every 3 weeks by intravenous infusion ( so 120 hours)
15811334|NCT04356157|Behavioral|Behavioural change interventions|"The study evaluates three different interventions aimed at improving adherence and retention to Anti Retroviral therapy among HIV positive women through engagement with their life partner. The interventions are 1) opening the facility once a month, only for men, special day; 2) testing peer-to-peer counselling among men, male champions; 3) providing incentive to all women accompanied by their partners at the facility, nudge or incentive."
15811335|NCT04356144|Diagnostic Test|Thrombin Generation Assay (TGA)|"TGA via a fluorimetric module. Coagulation cascade is activated upon addition of different concentrations of tissue factor and phospholipids. The fluorogenic substrate Z-Gly-Gly-Arg-AMC (ZGGR-AMC) is cleaved by formed thrombin over time. By plotting the changes in fluorescence as a function of time (cnt/min), it depicts the Thrombin Generation Curve (thrombin generated - plotted against time). The area under the thrombin curve is defined as the endogenous thrombin potential (ETP)."
15811336|NCT04356144|Diagnostic Test|Thrombomodulin Modified Thrombin Generation Assay (TGA-TM)|Recombinant Human Thrombomodulin (TM) is added to the conventional TGA. When recombinant TM is added, the protein C system is fully activated and therefore the ETP obtained reflects both the anti- and procoagulant factors.
15811337|NCT04356131|Other|progressive relaxation exercises and massage|Progressive relaxation exercises included 30 minute rhythmic breathing and muscle relaxation exercises were demonstrated in the second part of the CD with river sounds and verbal instructions. Massage techniques were performed on the site between upper symphysis pubis and umbilicus with 15 minute effleurage demonstrated in the third part of the CD with nature sound.
15811338|NCT04356118|Drug|Recombinant Human Endostatin|endostatin 7.5mg/㎡/d，Once a day for two weeks, take a week off,start the next cycle, up to four cycles .We advocate a highly individualized treatment plan according to each patients specific manifestations of the disease process.
15811339|NCT04356118|Drug|intrathcal methotrexate|Intrathecal chemotherapy specified dose on specified days.
15811340|NCT04356118|Drug|Targeted drugs for non-small cell lung cancer|EGFR Mutation: Erlotinib，Afatinib，Osimertinib, et al. ALK ROS1 Mutation:Crizotinib,Ceritinib,Alectinib ,et al. BARF Mutation:Vemurafenib,et al. Other Mutation: other Targeted drugs .
15811341|NCT04356105|Drug|Minimal stimulation protocol|Letrozole, Recombinant FSH, GnRH antagonist
15811342|NCT04356105|Drug|Microflare protocol|OCP, GnRH agonist, Recombinant FSH
15811343|NCT04356105|Procedure|IVF/ICSI cycle|Involving ovum pickup and embryo transfer
15811344|NCT04356092|Diagnostic Test|2D perfusion digital subtraction angiography of the foot.|2D perfusion digital subtraction angiography of the foot was performed after infrapopliteal angioplasty and Perfusion Blood Volume (PBV), Mean Transit Time (MTT), and Perfusion Blood Flow (PBF) maps were extracted by analyzing Time-Intensity Curves and signal intensity on the perfused vessel mask.
15811345|NCT04356079|Diagnostic Test|International Headache Society Test|Thorough History of Patients and families
15811346|NCT04356066|Diagnostic Test|serum cxcl10 by ELISA|serum sample
15811347|NCT04356040|Device|TactiFlex SE|Radiofrequency ablation with the TactiFlex SE ablation catheter to treat paroxysmal AF. The procedure should be performed according to the TactiFlex SE investigational Instructions for Use document using the recommended ablation parameters as noted in the document.
15811348|NCT04356040|Device|TactiFlex SE - HSP|Radiofrequency ablation with the TactiFlex SE ablation catheter to treat paroxysmal AF. Subjects in the HSP Substudy are to undergo the same study procedures as subjects in the main study, except that ablation power settings of 40-50 Watts are to be used in the left atrium, unless there is a medical reason to use a lower power.
15811349|NCT04356027|Procedure|ICA (Invasive Coronary Angiography)|Patients will undergo a Pre-PCI Angiography
15811350|NCT04356027|Procedure|OCT|OCT pullback images will be collected pre-PCI and (optional) post-PCI procedure
15811351|NCT04356027|Procedure|FFR|FFR will be measured
15811352|NCT04356027|Other|VFR Analysis|VFR will be calculated offline using the OCT pullback images
15811353|NCT04356001|Procedure|Socket preservation|'One-Piece' autologous tuberosity graft combining hard and soft tissue, harvested from the maxillary tuberosity, placed in extraction sockets.
15811354|NCT04355988|Procedure|Nonsurgical root canal therapy|After administration of LA and rubber dam isolation, acess cavity will be prepared using carbide burs in high speed hand piece with copious irrigation. Working length will be determined using root ZX apex locator and will be verified radiographically. Canal preparation will be done with protaper rotary instruments in which Sx to S2 will be used to shape the canals and F1 and F2 will be used to finish until the apex. 5ml of 5.25% NaOCl will be used as irrigant after each instrument. After instrumentation , the canals will be irrigated with 5.0 ml of 17% EDTA for 1minute followed by irrigation with 5.0 ml of 5.25% NaOCl. Canals will be dried with absorbent paper points, filled with calcium hydroxide paste and access cavity will be restored with IRM. Patients will be recalled after 1 week.At the next appointment, after paste removal, copious irrigation with 5.25% NaOCl will be done and canals will be dried with paper points. Canals will be obturated with Gutta-Percha and ZOE based sealer.
15811355|NCT04355962|Drug|Sevoflurane|Sedation with sevoflurane (etSevo 0.5-1.5 Vol %) for 48 hours in patients with COVID-19 ARDS
15811356|NCT04355962|Drug|Intravenous drug|Intravenous sedation in control group will be continued as initiated at the ICU e.g. propofol, fentanyl, midazolam, dexmedetomidine
15811357|NCT04355949|Diagnostic Test|Serum vitamin D, vitamin B12, folic acid|Serum vitamin D, vitamin B12, and folic acid levels will be assessed
15811358|NCT04355936|Drug|Telmisartan arm will receive 80 mg Telmisartan twice daily plus standard care.|Control arm will receive standard care.
15811359|NCT04355910|Behavioral|Calorie restriction|"Participants randomized to IFD were asked to restrict energy and carbohydrate on two non-consecutive days each week (75% energy restriction) and to consume a plant foods-based diet that met their estimated energy requirements for the remaining 5 d of the week.
~The CCR group was prescribed a daily plant foods-based diet that was relatively low in fat with moderate energy-restriction (25% energy restriction).
~The plant foods-based diet included adequate fruit and vegetable, nuts and seeds, whole-grain cereals, olive oil, fish and seafood, a moderate consumption of dairy products, poultry, eggs, and lean red meat."
15811360|NCT04355897|Biological|Convalescent COVID 19 Plasma|Subjects will be transfused intravenously with 500 mls of convalescent COVID 19 plasma
15811361|NCT04355884|Diagnostic Test|Standard 12-lead ECG, NT-proBNP, echocardiography|Cardiac assessment
15811374|NCT04355845|Drug|Sumatriptan|25 milligrams (mg) single dose tablet
15811375|NCT04355845|Drug|PF-06651600|PF-06651600 400 mg single dose
15811376|NCT04355832|Drug|Glucagon-like peptide-1|Infusion of Glucagon-like peptide-1
15811377|NCT04355832|Drug|Placebos|Infusion of normal saline solution that will mimic Glucagon-like peptide-1
15811378|NCT04355819|Behavioral|Disclosure timing|When patients are told that a hernia was present on the CT scan
15811379|NCT04355806|Drug|PD-1/PD-L1 inhibitors|Including nivolumab, pembrolizumab, atezolizumab, and durvalumab, et al.
15811380|NCT04355806|Biological|Inactivated trivalent influenza vaccine|Including two type A viruses, H1N1 and H3N2, and one type B virus, B/Brisbane.
15811381|NCT04355793|Drug|Ruxolitinib|Ruxolitinib starting dose level 5 mg orally, twice daily (BID).
15811384|NCT04355754|Device|Ventil - a gas flow divider|Checking ventilation parameters set and obtained and clinical parameters while ventilating the patient and an artificial lung simultaneously, using inspiratory flow divider.
15811385|NCT04355741|Other|Exposure|Individuals with SARS-CoV-2 exposure and COVID-19 symptoms.
15811386|NCT04355728|Biological|Umbilical Cord Mesenchymal Stem Cells + Heparin along with best supportive care.|UC-MSC will be administered at 100x10^6 cells/infusion administered intravenously in addition to the standard of care treatment.
15811387|NCT04355728|Other|Vehicle + Heparin along with best supportive care|Best supportive care treatment per the treating hospital protocol.
15811388|NCT04355689|Drug|NPI-001|oral tablet
15811389|NCT04355689|Other|Placebo|Placebo tablets
15811390|NCT04355676|Drug|Selinexor|20 mg selinexor oral tablet.
15811391|NCT04355663|Behavioral|Motor program activating therapy|Pacients underwent two months' therapy consisted of 16 face-to-face sessions (1 hour, twice a week for two months).
15811392|NCT04355663|Behavioral|Vojta's reflex locomotion|Pacients underwent two months' therapy consisted of 16 face-to-face sessions (1 hour, twice a week for two months).
15811393|NCT04355663|Behavioral|Functional electric stimulation|Pacients uderwent two months' therapy. They used the whole time Functional electric stimulation during activities of daily living and underwent 2 individual sessions of Motor program activating therapy.
15811394|NCT04355650|Other|Clinical decision support tool|Adults (aged 18-64 years) who meet DSM-5 diagnostic criteria for non-psychotic unipolar major depressive disorder (MDD) and meet study eligibility criteria will receive 8 weeks of open-label treatment with an SSRI or SNRI antidepressant. Depressive symptoms will be assessed using the subject- and clinician-rated versions of the 16-items QIDS scale (QIDS-SR and QIDS-CR) and the 17-item HAMD at baseline, week 2 (via telephone), week 4, and week 8; with an additional phone contact at week 24. The QIDS scale scores at 2- and 4-weeks will be entered into the AHI-based clinical decision support tool, and the outcome predicted by the tool (e.g., the predicted eventual treatment outcome at 8 weeks) will be recorded. Clinicians and patients will be blinded to the clinical decision support tool prediction of outcome provided at the 2- and 4 weeks.
15811395|NCT04355637|Drug|Inhaled budesonide|adding budesonide to standard of care for pneumonia in COVID19 positive patients
15811396|NCT04355611|Other|Evaluation of the epidemiological characteristics of coronavirus infection (SARS-CoV-2)|Epidemiological characteristics of coronavirus infection (SARS-CoV-2) in patients with MS or NMO
15811397|NCT04355598|Drug|Lidocaine-Prilocaine cream|2 mL of the Lidocaine-Prilocaine cream will be placed on the anterior lip of the cervix by a Q-tip applicator, followed by 2 mL will be introduced in the cervical canal 7 minutes prior to IUD insertion
15811398|NCT04355598|Drug|glyceryl trinitrate cream|2 mL of the glyceryl trinitrate cream will be placed on the anterior lip of the cervix by a Q-tip applicator, followed by 2 mL will be introduced in the cervical canal 7 minutes prior to IUD insertion
15811399|NCT04355598|Drug|placebo cream|2 mL of the placebo cream will be placed on the anterior lip of the cervix by a Q-tip applicator, followed by 2 mL will be introduced in the cervical canal 7 minutes prior to IUD insertion
15811400|NCT04355585|Drug|Colchicine Tablets|1.8mg of Colchicine given over 1 hour (1.2 mg followed by 0.6 mg 1 hour later)
15811401|NCT04355585|Drug|Placebo oral tablet|Placebo given over 1 hour (first tablet followed by second tablet 1 hour later)
15811402|NCT04355572|Drug|Vitamin D 4000IU daily|Randomized to receive vitamin D 4000IU daily
15811403|NCT04355572|Drug|Placebo|Randomized to placebo daily
15811404|NCT04355546|Other|Non-interventional|As this is a Non-interventional trial, only data obtained within the current routine management of COPD at outpatient respiratory centres or GP centres will be documented.
15811405|NCT04355533|Biological|serology test|volume according to child weight
15811406|NCT04355533|Biological|nasopharyngeal swab|nasopharyngeal swab for PCR
15811407|NCT04355533|Biological|rectal swab|rectal swab for PCR
15811408|NCT04355533|Biological|saliva sample|for biocollection
15811409|NCT04355520|Drug|TQ-B3525|TQ-B3525 tablets were taken orally, once daily in 28-day cycle; The doses were 20 mg and 30 mg.
15811410|NCT04355520|Drug|Fulvestrant injection|Fulvestrant injection 500mg administered intravenously (IV) on day 1, day 15 of first cycle and on day 1 of follow-up treatment cycle. Each cycle is 28 days.
15811411|NCT04355507|Diagnostic Test|Chest computed tomography (CT)|Chest computed tomography (CT) examination
15811412|NCT04355507|Diagnostic Test|Reverse-transcription polymerase chain reaction (RT-PCR)|Identification of viral RNA by reverse-transcription polymerase chain reaction
15811413|NCT04355494|Biological|eculizumab|Eculizumab at doses of 900-1200 mg will be administered intravenously (up to 7 doses)
15811414|NCT04355468|Drug|Opioid Anesthesia|In patients in the Control group for surgical analgesia fentanyl was used. For induction of anesthesia used 1.5 µgkg-1, then fractional doses of fentanyl 1 to 3 µgkg-1 were administered if heart rate (HR) or mean blood pressure rose more than 20% above the base-line value obtained just before surgery commenced.
15811449|NCT04355143|Drug|Colchicine Tablets|COLCRYS (colchicine, USP) tablets for oral administration, containing 0.6 mg of the active ingredient colchicine USP, administered po every 12 hours x 30 days.
15811415|NCT04355468|Drug|Opioid Free Anaesthesia|In the OFA group, a single-shot ThPVB was performed at the Th3 to Th4 level, approximately, 2.5 to 3 cm lateral to the tip of a spinous process. Plain bupivacaine (0.3 ml kg-1) was then injected after a negative aspiration test for air or blood. The efficacy of the blockade to cold was checked after 20 min with a plastic ampoule of saline kept in the freezer. A difference in the sensation to cold between the blocked and unblocked sides was taken to indicate an effective block. After ThPVB was performed a continuous intravenous infusion of lidocaine and ketamine was started: immediately after induction of anesthesia, lidocaine was administered as a bolus i.v. at a dose of 1.5 mgkg-1 and ketamine in bolus i.v. 0.35 mgkg-1, followed by an infusion of lidocaine 2.0 mg/kg-1/ h for 2 hours, continued at a dose of 1.2 mg/kg-1/ h and ketamine infusion 0.2 mg/kg-1/ h for 2 hours, continued at a dose of 0.12 mg/kg-1/ h.
15811416|NCT04355455|Drug|Citalopram|40 mg citalopram intravenously
15811417|NCT04355455|Drug|Placebo|Saline solution
15811418|NCT04355442|Procedure|Facial fractures reduction or osteosynthesis|Facial fractures reduction or osteosynthesis
15811419|NCT04355429|Drug|captopril 25mg|Drug administration
15811420|NCT04355416|Drug|curcumin Oral gel|application of curcumin oral gel after scaling and root planing
15811421|NCT04355416|Procedure|subgingival scaling and root planing|subgingival scaling and root planing without application of curcumin gel
15811422|NCT04355403|Device|Hyalo Gyn gel in prefilled applicators|One vaginal application of Hyalo Gyn gel every 3 days to a total of 12 consecutive weeks.
15811423|NCT04355377|Other|Non intervention|Non intervention
15811424|NCT04355364|Drug|Dornase Alfa Inhalation Solution [Pulmozyme]|Administered by nebulization, at a dose of 2500 IU twice daily, 12 hours apart, for 7 consecutive days
15811425|NCT04355364|Procedure|standard procedure|Patients will receive the usual care in accordance with good practice.
15811426|NCT04355351|Other|blood sampling|blood sampling done on hospital staff without sars-coV-2 symptoms
15811427|NCT04355351|Other|additional blood tubes|Additionnal blood tube taken during the classical blood sampling in hospital
15811428|NCT04355325|Device|modified monolithic zirconia crowns|outcomes and complications of implant restoration
15811429|NCT04355325|Device|Metal Ceramic crowns|outcomes and complications of implant restoration
15811430|NCT04355312|Diagnostic Test|Use of Indocyanine Green in laparoscopic ovarian cystectomy|"During intraperitoneal cystectomy or Plasmajet destruction of the cyst, as a benign organic cyst requiring surgical treatment, peroperatively, at the end of the cystectomy procedure, injection by the anesthetist on a peripheral venous route of a bolus of Indocyanine green diluted 0.2mg / kg. Installation of the SPIES camera system (KARL STORZ GmbH & Co.KG, Tuttlingen, Germany).
~Evaluation of the degree of fluorescence at the location of cystectomy or destruction of the cyst.
~A fluorescence score between 0 and 4 (on the model of a Likert scale) will be used for the evaluation of fluorescence.
~A second reading of the Likert scale results will be carried out by a second inspector so that the score is as objective as possible. Then, second evaluation technique realized by the METAMORPH software, which will assign a raw and objective score according to the fluorescence visualized."
15811431|NCT04355299|Behavioral|balance training|The training to improve balance is to work on the core muscle groups that help to maintain your posture.,and increase muscular strength.
15811432|NCT04355299|Behavioral|resistance training|Resistance training is a form of exercise that improves muscular strength and endurance. During a resistance training workout, you move your limbs against resistance provided by your body weight, gravity, bands, weighted bars or dumbbells.
15811433|NCT04355299|Behavioral|aerobic exercise|Aerobic exercise is any activity that gets your blood pumping and large muscle groups working. It's also known as cardiovascular activity.
15811434|NCT04355299|Behavioral|usual care|received usual care
15811435|NCT04355286|Drug|Bemotrizinol|Market-image topical sunscreen formulation containing BEMT (6%)
15811436|NCT04355273|Drug|Heparin|heparin with a concentration of 2 U/ml is used for pressurized continuous flushing of the invasive arterial pressure monitoring tube
15811437|NCT04355273|Drug|Heparin|heparin with a concentration of 4 U/ml is used for pressurized continuous flushing of the invasive arterial pressure monitoring tube
15811438|NCT04355273|Drug|normal saline|normal saline is used for pressurized continuous flushing of the invasive arterial pressure monitoring tube
15811439|NCT04355260|Procedure|Echocardiography-guided Radiofrequency ablation for Hypertrophic obstructive Cardiomyopathy (HOCM).|Echocardiography-guided Radiofrequency ablation for Hypertrophic obstructive Cardiomyopathy (HOCM).
15811440|NCT04355247|Drug|MethylPREDNISolone 80 Mg/mL Injectable Suspension|"Patients will be admitted to a regular room in the hospital (not ICU)
~They will be monitored closely with vital signs every 4 hours to ensure their respiratory and cardiovascular status do not deteriorate.
~Methylprednisolone 80 mg IV bolus injection will be given daily x 5 days starting upon day 1 of admission to hospital."
15811441|NCT04355234|Diagnostic Test|identify SARS-CoV-2 infection by serology|Blood samples at delivery to identify SARS-CoV-2 infection by serology
15811442|NCT04355234|Biological|collection of biological samples|Creation of a specific collection of biological samples for new investigations thanks to the collection of several biological samples at the time of maternal SARS-CoV-2 infection, at delivery and in the postpartum period in the parturient and her newborn.
15811443|NCT04355221|Procedure|pulsed radiofrequency|Pulsed radiofrequency of the trigeminal nerve using NeuroTherm NT 1100 RF generator device
15811444|NCT04355208|Other|(3M™ Filtek™ Universal )|universal nanofillers resin composite (3M™ Filtek™ Universal )
15811445|NCT04355169|Drug|Naldemedine|Orally disintegrating tablets administered orally twice a day.
15811446|NCT04355169|Drug|Placebo|Orally disintegrating tablets administered orally twice a day.
15811447|NCT04355156|Drug|Axitinib|"All patients randomised to this arm will receive 3mg BD, and increased at 2 weeks to 5mg BD
~Outpatient monitoring at 2 week intervals for a minimum of 8 weeks, with 2 weekly liver contrast ultrasound for assessment of differential blood supply (CEHPI)
~At 8 weeks, after tumour CT RECIST assessments, responders will continue monotherapy. In non-responders, those with disease progression, monotherapy can be continued if patient chooses to continue and if tolerated"
15811448|NCT04355156|Drug|Placebo|"All patients receiving placebo will receive tablets to take BD
~Outpatient monitoring at 2 week intervals for a minimum of 8 weeks, with 2 weekly liver contrast ultrasound for assessment of differential blood supply (CEHPI)"
15811450|NCT04355143|Other|Current care per UCLA treating physicians|Current care
15811451|NCT04355130|Dietary Supplement|Iron, vitamin B12 and acid folic supplementation|Vitamin and iron supplementation is administered one-two weeks before donation, and consist of iron supplementation (i.v. infusion of 20 mg/Kg ferric carboxymaltose in saline 100 ml), s.c. injection of 1 mg of vitamin B12 and acid folic 5 mg/die per os until day +15 post BM donation. BM collection is carried out by the transplant team and a maximal dose of 20-22 ml/Kg of the donor body weight is collected under general anesthesia (induction with fentanyl 1-3 mcg/Kg, Propofol 2-3 mg/Kg, rocuronium 0,6 mg/Kg and mantenaince with sevoflurane 0,8 MAC). Noninvasive cardiac output, blood pressure and hemoglobin monitoring are carried out during the entire procedure and in in the recovery room using the ClearSight™ system (Edwards Clinical) and the Radical Pulse co oxymeter (Masimo). After discharge from the hospital, donors will be revaluated on day + 7 after BM collection, and blood tests will be repeated in outpatient setting.
15811453|NCT04355104|Behavioral|Education|"A one hour educational session per week for 4 weeks. In a total of 4 sessions of education, the content based on LBP Clinical Practice Guidelines which recommended that education and counseling strategies for patients with low back pain.
~Education session will be through video lecturing as a motivated tool of education for all subject who are in experimental group, this video will repeated the same in every educational session and will be sent for all participants.
~The neuroscience education will be by the therapist using interactive slide show and hand-drawing images.
~In addition to the education video, slide show, we will specify the education for every patient to give him all that he need, questions and details, mention his case on real spine to explore it and to determine the expected goal from what he need and what we have."
15811454|NCT04355104|Behavioral|Standard physical therapy|Two session physical therapy per week for 4 weeks. The physical therapy will be based on patients case.
15811455|NCT04355091|Behavioral|Emotional Freedom Techniques (EFT)|It combines cognitive therapy, acceptance and stability therapy, and acupuncture point stimulation, and is based on manual stimulation of acupuncture points specific to Shiatsu or other acupressure massage forms, rather than using acupuncture needles.
15811456|NCT04355078|Other|Neuromuscular Training|Muscular and neural training by complex exercises
15811457|NCT04355078|Other|Strength Training|Strength Training
15811458|NCT04355065|Behavioral|Cognitive Traning with The Secret Trail of Moon|Patients are pharmacologically stable and receive a cognitive intervention with our videogame once a week in the hospital.
15811459|NCT04355065|Behavioral|Cognitive Traning with Therapeutic Chess|This group is pharmacologically stable. This group performs cognitive training through a therapeutic chess protocol designed by a chess psychologist. The training is done from home and we contact them weekly to correct the exercises done and to follow up.
15811460|NCT04355065|Drug|Control Group|"These patients continue their stable pharmacological treatment and do not receive any additional cognitive intervention.
~They are contacted weekly by phone to follow up on the group."
15811461|NCT04355052|Drug|hydroxychloroquine in combination with camostat mesylate|Two drugs which may act as antivirals against SARS CoVid 2 (Hydroxychloroquine may also act as an immunomodulator, Camostat mesylate is a protease inhibitor)
15811462|NCT04355052|Drug|Hydroxychloroquine in combination of Azithromycin|Hydroxychloroquine 400 mg BID on day 1 and than 200 mg BID on days 2-5 + Azithromycin 500 mg QD on day 1 and 250 mg QD on days 2-5
15811463|NCT04355039|Drug|Pomalidomide|4 mg Days 1-21
15811464|NCT04355039|Drug|Dexamethasone|40 mg Days 1, 8, 15 and 22
15811465|NCT04355039|Drug|INCB053914 50 mg bis in die (BID)|Dose level 0: 50 mg BID
15811466|NCT04355039|Drug|INCB053914 65 mg BID|Dose level 1: 65 mg BID
15811467|NCT04355039|Drug|INCB053914 80 mg BID|Dose level 2: 80 mg BID
15811468|NCT04355026|Drug|Bromhexine Oral Tablet and/or hydroxychloroquine tablet|bromhexine 16 mg TID hydroxychloroquine 200 mg BID
15811469|NCT04355013|Device|Core emperature monitoring|Monitoring core temperatures with probes placed in the arterial outlet and venous inlet of extracorporeal pump, pulmonary artery, bladder, nasopharinx and forehead using a doublé-sensor probe
15811470|NCT04355000|Procedure|Hall technique|SS Crown will be cemented on primary carious molar which satisfy the inclusion criterion without any carious removal, without any tooth preperation, without any local anaesthesia.
15811471|NCT04355000|Procedure|RMGIC restoration|Complete removal of caries and filling will be done with RMGIC material
15811472|NCT04354987|Drug|CKD-391 10/10mg|Drug T: CKD-391 10/10mg(Other Name: Test Drug)
15811473|NCT04354987|Drug|D090, D337|D090 and D337 co-administration(Other Name: Reference drug)
15811474|NCT04354974|Behavioral|Evaluation|Evaluation of a cognitive remediation program for mood disorders
15811475|NCT04354961|Drug|Almonertinib|Almonertinib 110mg PO once daily. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
15811476|NCT04354961|Drug|Paclitaxel and carboplatin|"Paclitaxel 175 mg/m² IV on day 1 of each 21 day cycle，4-6 cycles. Carboplatin AUC=5 IV on day 1 of each 21 day cycle, 4-6 cycles.
~A cycle of treatment is defined as 21 days of once daily treatment."
15811477|NCT04354948|Behavioral|Pain (hypertonic saline)|A bolus injection (1 ml) of hypertonic saline (5.8%) is injected into the right quadriceps femoris of the quadriceps femoris muscle 1 minute before performance of the 3 min wall squat exercise
15811478|NCT04354948|Behavioral|No pain (Hypotonic saline)|A bolus injection (1 ml) of isotonic saline (0.9%) is injected into the right quadriceps femoris of the quadriceps femoris muscle 1 minute before performance of the 3 min wall squat exercise
15811479|NCT04354935|Device|rTMS|Three stimulation methods can be proposed to the patient . Different stimulation methods that can be used
15811518|NCT04354610|Procedure|Telephone follow-up|Telephone follow-up at 3 months after discharge from hospital
15811578|NCT04354025|Drug|Ara-C|-Ara-C (dose: 2000mg/m^2 per dose) will be given daily for a total of 5 doses administered as IV infusion over 3 hours, starting the same day as fludarabine.
15811937|NCT04351308|Drug|Apatinib Mesylate|anti-angiogenesis tyrosine kinase inhibitors 500 mg orally daily
15811480|NCT04354922|Behavioral|Exercise intervention|Subjects in attention control group will receive one session of 75 minutes of stretching exercise weekly. All walking exercise session will be performed on motor-driven treadmill. Subjects in moderate-intensity walking groups will walk at an intensity of 3.25 metabolic equivalents (METs). Subjects in vigorous-intensity walking groups will brisk walk at an intensity of 6.5 metabolic equivalents (METs). Warm-up and cool-down will be provided before and after the training. Participants who failed to achieve 80% attendance will be excluded from the study. All exercise sessions were supervised by qualified athletic coach.
15811481|NCT04354909|Other|s-CD95-L|levels of s-CD95-L (ELISA test)
15811482|NCT04354896|Drug|Levothyroxin|The intervention will start with Levothyroxine 50 mcg daily (reduced to 25 mcg in subjects <50 kg of body weight or if known coronary heart disease - previous myocardial infarction or symptoms of angina pectoris) vs. matching placebo; at 3 months, if the serum TSH level is <0.4 mU/L, dose will be reduced by 25 mcg; TSH 0.4 to 4.6 mU/L, no change to dose; TSH ≥4.6 mU/L, additional 25 mcg. The process will be repeated at 12 months, then annually; mock titration will be performed in the placebo group. The maximum possible dose of Levothyroxine which will be prescribed is 150 mcg (after 4 increments of 25 mcg at 3 months, 1, 2, 3 years; from the starting dose of 50 mcg).
15811483|NCT04354896|Drug|Placebo|Control patients will obtain a placebo pill of the same characteristics as the intervention drug, and mock titration will be carried out identically to the intervention drug.
15811484|NCT04354883|Procedure|External Chest Compressions on Manikin in Underwater Setting|Two different methods of CPR in an analogue model of mircogravity
15811485|NCT04354870|Drug|Hydroxychloroquine (HCQ)|Loading dose: 600 mg, oral, 1 day Maintenance dose: 200 mg, oral, daily, for 90 days
15811486|NCT04354857|Other|olfactory and gustatory tests|"Participants rate quality of sense of smell and taste.
~Olfaction test: Sniff 10ml test tube containing 1.5ml air freshner (Mifleur Citron, Coldis, Entraigues sur Sorgues, France) and rate perception of odor.
~Gustatory test: Taste a pinch and sugar and salt and rate perception of sweet or salty taste"
15811487|NCT04354844|Behavioral|questionnaire|questionnaire
15811488|NCT04354831|Biological|anti-SARS-CoV-2 convalescent plasma|"SARS-CoV-2 convalescent plasma (1-2 units; ~200-400 mL maximum dose as 7 ml/kg adjusted IBW )
~Study drug will be administered as a single intravenous infusion"
15811489|NCT04354805|Drug|Chlorpromazine|(Oral dose of 50 mg/ day for 3 days then doubled to 100mg/day for further 11 days)
15811490|NCT04354792|Diagnostic Test|Serum SARs COV 2 IGg screening in health care workers|Blood samples will be collected from the enrolled HCWs. Sample collection, processing, and laboratory testing will follow guidance from the World Health Organization
15811491|NCT04354779|Diagnostic Test|a specifically designed self-administered questionnaire|The questionnaire consists of the following items: questions related to personal health, traveling activities, living situation, as well as inquiries of symptoms and comorbidities.
15811492|NCT04354766|Other|Blood sample|This study will require a blood sample (4 ACD tubes, 20 ml) at one time.
15811493|NCT04354753|Other|No Intervention|No intervention
15811494|NCT04354740|Procedure|with percutaneous coronary intervention (PCI) are with new-generation drug-eluting stents (DES)|"II-PCI:
~-Coronary angiography and intervention will be done according to the European guidelines of ACS revascularization.
~III-CABG:"
15811495|NCT04354727|Drug|APG-1252|infusion once weekly
15811496|NCT04354727|Drug|Ruxolitinib|taken orally twice a day
15811497|NCT04354714|Drug|Ruxolitinib|For patients unable to swallow pills, a ruxolitinib suspension will be administered through a nasogastric/orogastric tube
15811498|NCT04354714|Procedure|Peripheral blood draw|-Screening, Day 2, Day 4, Day 8, Day 15, and Day 29
15811499|NCT04354701|Other|Web-based REDCap survey|The survey takes approximately 5-10 minutes to complete and includes five parts: 1) basic demographics about the patient, including performance status and comorbidities; 2) initial COVID-19 diagnosis and clinical course; 3) cancer and cancer treatment details; 4) respondent details; 5) long-term COVID-19 outcomes.
15811500|NCT04354688|Device|T3 Certain Tapered Implant|Patients will be randomized to receive either the T3 Certain Tapered with DCD (Test) or the T3 Certain Tapered without DCD (control/active comparator). Both types of implants will be rehabilitated in the same manner (early loading)
15811501|NCT04354675|Genetic|Automated program (ChatBot)|Pre-test counseling and information through a pre-test automated genetic counseling program (ChatBot)
15811502|NCT04354675|Genetic|Genetics counselor|Traditional in-person genetic counseling
15811503|NCT04354675|Other|BCGCKQ Survey|Survey assessing Breast Cancer Genetic Counseling Knowledge Questionnaire (BCGCKQ)
15811504|NCT04354675|Other|Satisfaction Survey|Survey assessing satisfaction with Decision-Genetic Testing
15811505|NCT04354675|Device|Genetic testing|Genetic testing for all participants will assess for a mutation in 47 genes commonly associated with hereditary cancer syndromes (Invitae's Common Hereditary Cancer Panel) for those who choose to complete testing.
15811506|NCT04354662|Drug|Toripalimab|240mg d1
15811507|NCT04354662|Drug|Docetaxel|50mg/m2, d1;
15811508|NCT04354662|Drug|Fluorouracil|2600 mg/m², d1
15811509|NCT04354662|Drug|Leucovorin|200 mg/m², d1
15811510|NCT04354662|Drug|Oxaliplatin|85 mg/m², d1
15811513|NCT04354636|Drug|Silver modified atraumatic restorative treatment|Silver diamine fluoride that will be applied during atraumatic restorative treatment
15811514|NCT04354636|Other|Atraumatic restorative treatment|Using atraumatic restorative treatment without applying silver diamine fluoride
15811515|NCT04354623|Other|A 6-minute walk test|Each subject will perform a 6-minute walk test during which gait assessment will be obtained from the APDM system (Portland, OR). In addition there will be four video cameras (on the front, back and sides) that will measure raw video data for our gait analysis. The camera does not record any facial data (in fact, 'deepfake' software in the system deletes all facial details) and the patient's movements are converted to a 'stick figure' prior to being saved in the system.
15811516|NCT04354610|Procedure|Biological samples specific to research|Blood samples, saliva collection, and urine collection to carry out biomarker assays and for the constitution of a biological collection.
15811517|NCT04354610|Procedure|Clinical examination|Clinical examination
15811938|NCT04351308|Drug|Camrelizumab|anti-PD-1 antibody 200mg ivgtt. Q2W
15811520|NCT04354571|Procedure|Erector spinae plane block|An ultrasound-guided Erector spinae plane block was performed with the patient lying on the his side and the surgical side on the top. After skin disinfection, sterile draping was be placed and the ultrasound probe was sheathed. The level of the block was the transverse process of L2. The block was performed using a 9-12 MHz linear probe (LOGIQe, GE Healthcare, USA), which was placed in a parasagittal plane 1 cm from the posterior midline. The deep plane to the erector spinae muscle (ESM) was identified, and a 22 G, 50 mm insulated needle (Sonoplex Stim, Pajunk, Germany) was inserted cranio-caudally in plane between the transverse process and the fascia of the ESM. After negative aspiration, 0.3 ml/kg of 0.25% bupivacaine was injected to confirm the correct position by visualizing the solution lifting the ESM off the transverse process.
15811521|NCT04354571|Procedure|caudal block|caudal block was performed using anatomical landmarks and ultrasound guided and confirmed with a concentration of bupivacaine of 0.25%.
15811522|NCT04354545|Drug|Xiidra (Lifitegrast ophthalmic solution) 5%|FDA approved lifitegrast opthalmic solution eye drop
15811523|NCT04354532|Procedure|Laparoscopic Banded Sleeve Gastrectomy|The investigators performed Laparoscopic Sleeve Gastrectomy adding a MiniMizer Ring (Bariatric Solutions), a radiopaque silicone ring with four closing positions. The ring has a blue colour and for this reason it can easily be found back in revision surgery. The pulling lid is left in place with all closing positions in order to be adjusted postoperatively without having to place a new ring. The ring is slightly elastic and the fixation loops provide an anchorpoint to fix the ring in place which prevents it from slipping
15811524|NCT04354493|Device|Myo-electric Gaming Interface|Non-significant risk, video game controller which maps myo-electric control signals to button presses.
15811525|NCT04354480|Biological|RSV Vaccine|Participants will receive single IM injection of Ad26.preF RSV based vaccine on Day 1.
15811526|NCT04354480|Other|Placebo|Participants will receive a single IM injection of matching placebo on Day 1.
15811527|NCT04354467|Drug|Acute kidney Injury due to nephrotoxic medications in the NICU|AKI will be defined using the KDIGO AKI definition
15811528|NCT04354454|Other|Fitbit|Participants will select a daily step goal and track their steps every day for 4.5 months.
15811529|NCT04354454|Other|Fitbit + Game + Support from a Teammate|"Daily Fitbit tracking for 4.5 months, divided into 2 parts.
~3 months on active intervention with Fitbit, a Game, and Support from a self-selected Teammate and pre-designed game.
~1.5 month follow-up period with Fitbit and social support teammate only"
15811530|NCT04354441|Drug|hydroxychloroquine sulfate 200 MG|Hydroxychloroquine sulfate (Plaquenil) 2MG will be taken twice a day for 10 days. Participants will be couriered the medication upon giving consent and will start taking the medication immediately.
15811531|NCT04354441|Drug|Placebo oral tablet|Placebo that is identical in appearance to the study medication will be taken twice a day for 10 days. It will be couriered to participants upon giving consent. They will start taking the medication immediately.
15811532|NCT04354428|Drug|Ascorbic Acid|Eligible participants in a household randomized to this study arm will receive ascorbic acid only or ascorbic acid and additional drug therapy
15811533|NCT04354428|Drug|Hydroxychloroquine Sulfate|Eligible participants in a household randomized to this study arm will receive hydrochloroquine and folic acid therapy
15811534|NCT04354428|Drug|Azithromycin|Eligible participants in a household randomized to this study arm will receive hydrochloroquine and azithromycin therapy
15811535|NCT04354428|Drug|Folic Acid|Eligible participants in a household will receive folic acid and an additional intervention drug
15811536|NCT04354428|Drug|Lopinavir 200 MG / Ritonavir 50 MG [Kaletra]|Eligible participants in a household randomized to this study arm will receive lopinavir-ritonavir therapy
15811537|NCT04354415|Procedure|Carpal tunnel or trigger finger release|Carpal tunnel or trigger finger release with and without the use of tourniquet
15811538|NCT04354402|Other|No intervention|No intervention
15811539|NCT04354389|Drug|DAS181|4.5 mg b.i.d
15811540|NCT04354389|Drug|Placebo|q.d. or b.i.d.
15811541|NCT04354389|Drug|DAS181|4.5 mg q.d.
15811542|NCT04354376|Drug|Loop diuretics, thiazides, dihydropyridines|Loop diuretics, thiazides, or dihydropyridines dispensing claim is used as the reference
15811543|NCT04354376|Drug|Telmisartan|Telmisartan dispensing claim is used as the exposure
15811544|NCT04354363|Other|Platelet rich plasma|Giving women PRP before ICSI
15811545|NCT04354350|Drug|Ramipril|Ramipril dispensing claim is used as the reference
15811546|NCT04354350|Drug|Telmisartan|Telmisartan dispensing claim is used as the exposure
15811547|NCT04354337|Behavioral|Sleep Innovations for Preschoolers with Arthritis (SIPA)|The SIPA intervention is interactive and personalized. Every week, parent will receive an email sent automatically through the system with instructions for this week's activity, designed to take about 30 minutes to complete. The SIPA weekly modules will begin with a learning module, then direct participants through goal setting, anticipated barriers, and problem solving. The intervention site will include fillable responses to queries, instructions, and assignments. Tasks for parents and their young children will use multimedia elements to enhance delivery of information, such as links to videos and pictures targeting self-efficacy, motivation, and patient activation. Submissions and progress will be monitored by the study team, who will send email, call or text with reminders (whichever the family prefers) and answer questions as needed, review progress, and help problem solve any technology issues or barriers to implementing skills.
15811548|NCT04354324|Drug|Radioiodine|The test group: low dosage (30mci). The control group: high dosage (100mci).
15811549|NCT04354311|Device|ANI|Under steady state total intravenous anaesthesia with propofol and remifentanil at constant dosage, tetanus stimulation of the ulnar nerve was performed followed by orotracheal intubation. The variation of ANI and hemodynamic parameters as well as the somatic response associated with both maneuvers were collected.
15811550|NCT04354298|Behavioral|Improvisational Dance Class|Hour long movement classes that meet weekly for 12 weeks.
15811551|NCT04354285|Other|Observational|Observational
15811552|NCT04354272|Other|Questionnaire|Questionnaire for the satisfaction of patients consulting the odontological emergencies of the GHPS during COVID 19.
15811577|NCT04354025|Drug|Fludarabine|-Fludarabine (dose: 30 mg/m^2 per dose) will be given daily beginning on Day -7 for a total of 5 doses administered as an IV infusion over 30 minutes.
15811641|NCT04353531|Device|Surgical mask|A procedure mask will be used to cover patient's face after HFNC is initiated.
15811553|NCT04354259|Drug|Peginterferon Lambda-1A|Peginterferon lambda is a covalent conjugate of human recombinant non-pegylated IFN lambda (IFN L) and a 20-kDa linear PEG chain. Peginterferon lambda Injection is a sterile, nonpyrogenic, ready-to-use solution (0.4 mg/mL) that is clear to opalescent, colorless to pale yellow, and essentially free of particles. Lambda Injection is provided in a 1-mL long Type I glass syringe (0.18 mg/syringe) with a staked 29-gauge, 1/2- inch, thin-walled needle. The syringe has a rigid needle shield and is stoppered with a plunger stopper. Syringes are prefilled with a solution of Peginterferon lambda Injection, mannitol, L-histidine, polysorbate 80, hydrochloric acid, and water for injection; they are intended for a single use at adjustable doses. The syringe is marked with dose indicator lines, which are used as a reference point for administering the correct dose.
15811554|NCT04354259|Other|placebo|injection of 0.9% sodium chloride (normal saline) solution. A plastic 1 mL syringe will be prefilled by the study pharmacy. Each syringe will contain 0.5 mL (0.45 mL to match the volume of the Interferon plus 0.05 mL overfill) to allow for needle priming by the unblinded study nurse.
15811555|NCT04354246|Drug|Dose escalation: COM902 monotherapy.|COM902 monotherapy administered IV every 3 weeks in sequential dose escalation doses in cohorts of subjects.
15811556|NCT04354246|Combination Product|Evaluation of safety/tolerability: COM902 in combination with COM701 (both at the RDFE)|Both study drugs will be evaluated at the RDFE for assessment of safety and tolerability. All study drugs will be administered IV every 3 weeks.
15811557|NCT04354246|Drug|Cohort expansion: COM902 (RDFE) monotherapy.|COM902 monotherapy (RDFE) in subjects with multiple myeloma. COM902 will be administered IV every 3 weeks.
15811558|NCT04354246|Drug|Cohort expansion: COM902 in combination with COM701 (both at the RDFE).|COM902 in combination with COM701 (both at RDFE) in subjects with select tumor types who have exhausted standard treatment - HNSCC, CRC (MSS), NSCLC. All study drugs will be administered IV every 3 weeks.
15811559|NCT04354233|Device|Physical activity intervention with connected devices|"Participants randomized in the intervention arm will receive recommandations in physical activity. They will also receive an activity tracker Withings Steel to wear during 6 months. The tracker will be connected to the Withings Health Mate application and the ABLE02 application. Participants will be encouraged to practice at least three walking sessions weekly of more than 10 consecutive minutes. Concerning the number of steps per day, the first objective will be determined according to the 6-min walking distance and to participants' preferences and capacities. The objective will be recalculated monthly according to the number of steps performed the previous week and will be adapted by the physical activity (PA) instructor and participants. Phone calls with the participants are regularly planned. Weekly quizzes on PA and nutrition will be proposed through the ABLE02 application. A messaging system and a phone line will be available for participants to contact the study team."
15811560|NCT04354220|Diagnostic Test|capnography monitoring|routinely used capnography monitoring
15811561|NCT04354220|Diagnostic Test|arterial blood gas|Routinely taken arterial blood gas values
15811562|NCT04354207|Diagnostic Test|Peripheral vein punction|Vitamin D level, vitamin D receptor genetic polymorphisms, allergen specific IgE and total IgE will be measured in peripheral blood
15811563|NCT04354207|Diagnostic Test|Stool collection|Gut microbiome will be investigated in stool samples.
15811564|NCT04354194|Procedure|Conventional Physiotherapy|Conventional Physiotherapy consist of Hotpacks, TENS and US.The participants were positioned in sitting and supported with a pillow under the head, 20 min hot pack was applied. Therapatic Ultrason were applied with the frequency of 1 MHz, intensity of 1,5 watt/cm² and duration of 5 minute. TENS was applied to the cervical region with 2-channel, 4 surface electrodes at 60-120 Hz, and 50-100 pulse duration for 20 minutes.
15811565|NCT04354194|Procedure|Osteopathic Manupilative Treatment|Osteopathic Manupilative Treatment consist of stretching the fascia to the cervical region, soft tissue mobilization to the surrounding muscles, cervical manual traction, passive joint mobilization to the 7 cervical spine, passive joint mobilization to the 1st costa, passive joint mobilization to the clavicle and passive joint mobilization to the sternum mobilization in supine and prome positions.
15811566|NCT04354168|Behavioral|mHealth Application|Nthabi mHealth Application delivers educational content and recommendations to minimize or eliminate health risks. The content is delivered via the Nthabi application downloaded on an Android phone smartphone. End-users can select from a list of topics relevant to the Lesotho population to engage with the conversational agent, Nthabi, and discuss conditions such as tuberculosis, HIV testing, healthy diet, and family planning.
15811567|NCT04354155|Drug|Enoxaparin Prefilled Syringe [Lovenox]|Twice-daily low-dose enoxaparin thromboprophylaxis (starting dose, 0.5 m/gkg subcutaneously q12 hours, adjusted to achieve a 4 hour post-dose anti-factor Xa level of 0.20-0.49 anti-Xa U/mL)
15811568|NCT04354142|Device|iSpy|iSpy is a novel healthcare application that hopes to address an important clinical need by facilitating carbohydrate counting using pictures or voice recognition. Proprietary algorithms adjust for portion size and identify hidden carbohydrates (such as in ketchup or other condiments) and quantify the amount of carbohydrates in a meal.
15811569|NCT04354129|Drug|Cutaquig®|Immunoglobulin replacement therapy with subcutaneous injections of Cutaquig® 165 mg/mL at home.
15811570|NCT04354116|Device|Rapid maxillary expansion|Palatal expanders of the HYRAX type, with bands on the first permanent molars will be used for patients in both groups. In the experimental group, the expander will be anchored mesially and bilaterally in mini-implants, in a technique known as rapid maxillary expansion assisted by mini-implants (MARPE). The control active group will be with conventional HYRAX expanders. The maxillary expansion protocol will be once a day for 2 weeks.
15811571|NCT04354116|Device|Maxillary Protraction|Protraction hooks will be projected around the upper canine area. In the experimental group (MARPE), the appliance will be anchored mesially and bilaterally in mini-implants. The control active group will be anchored with conventional HYRAX expanders. Both groups will be treated with maxillary protraction with a Petit-type face mask at night (12 hours a day).
15811572|NCT04354103|Drug|Atomoxetine|Atomoxetine
15811573|NCT04354090|Drug|JY09|Subcutaneous injection
15811574|NCT04354077|Device|DBS of the NAc|Deep Brain Stimulation of the Nucleus Accumbens
15811575|NCT04354051|Drug|Sodium Nitrite|Intravenous nitrite sodium infusion, dose 70μmol, of 5 minute duration (14μmol /min-1).
15811576|NCT04354025|Biological|Cytokine induced memory-like NK cells|-The CIML NK cells (maximum dose capped at 10 x 106/kg, minimum dose allowed is 0.5 x 106/kg) will be infused on Day 0 without a filter or pump.
15811939|NCT04351295|Drug|Favipiravir|Favipiravir
15811579|NCT04354025|Drug|G-CSF|-Filgrastim (dose: 5 mcg/kg per dose to a maximum of 300 mcg) will be given subcutaneously daily for a total of 5 doses starting the same day as fludarabine and ara-C.
15811580|NCT04354025|Drug|Interleukin-2|-IL-2 will be administered subcutaneously at a dose of 1 million units/m2 every other day from Day 0 to Day +12 (7 doses total).
15811581|NCT04354025|Procedure|Leukapheresis|-Donor only
15811582|NCT04354012|Combination Product|methylene blue, gentian violet, and ovine forestomach wound dressings|"Hydrofera Blue is an antibacterial foam dressing that contains methylene blue and gentian violet to manage wounds. This is a safe, non-cytotoxic product that can be worn for 7 days while not inhibiting growth factors. This products wicks bacteria into the foam and away from the wound surface using natural negative pressure through capillary flow.
~Endoform (ovine forestomach) is a natural dermal template used in all phases of wound healing. This product helps to stabilize, build, and organize tissue in acute and chronic wounds.
~Hypafix tape aids in stabilization of wound dressings. This productIt is easy to apply, skin friendly, and comfortable to use."
15811583|NCT04353999|Procedure|Socket sealing by diode laser photocoagulation|tooth extraction followed by socket grafting with bovine bone xenograft and finally sealed using 980 nm diode laser photocoagulation applied in a non-contact mode with a poer output of 1 watt in a continuous wave mode for 3-5 minutes
15811584|NCT04353999|Procedure|socket sealing with dense polytetrafluroethylene membrane|tooth extraction followed by socket grafting with bovine bone xenograft and finally sealed by a non-resorbable dPTFE membrane that is stabilized by suturing to the soft tissue margins of the socket
15811585|NCT04353986|Drug|Sofosbuvir and Ledipasvir|fixed dose tablet containing 400 mg sofosbuvir and 90 mg ledipasvir
15811589|NCT04353960|Diagnostic Test|electrocardiograph|electrocardiograph monitor during strabismus surgery
15811590|NCT04353947|Diagnostic Test|Mini Cognitive Examination (MCE)|This test provides information on temporal and spatial orientation, fixation, concentration and calculation, memory and language and construction.
15811591|NCT04353947|Diagnostic Test|Beck Depression Inventory-II (BDI-II)|This test evaluates the absence or presence of depressive symptoms.
15811592|NCT04353947|Diagnostic Test|Global Deterioration Scale (GDS)|This scale measures the level of deterioration of the subject.
15811593|NCT04353947|Diagnostic Test|Memory alteration test (M@T)|In this test different memory subtypes are evaluated.
15811594|NCT04353947|Diagnostic Test|Spanish-Complutense Verbal Learning Test (TAVEC)|This test is used to assess immediate memory, deferred memory and learning ability.
15811595|NCT04353947|Diagnostic Test|Barcelona test (BT)|"This test evaluates categorical evocation and verbal fluency. The categorical recall subtest consists of recalling the maximum number of words linked to a specific category animals in 1 minute. In the case of verbal fluency, the subject is asked to evoke the maximum number of words that begin with the letter p in 3 minutes."
15811596|NCT04353947|Diagnostic Test|Rey-Osterrieth Complex Figure Test (ROCFT)|In this test, the person must carefully copy a complex geometric drawing, which must be memorized later. The first part evaluates multiple cognitive processes such as planning, motor skills, working memory, and visual-constructive and spatial skills. In the second part, memory is evaluated.
15811597|NCT04353947|Diagnostic Test|Frontal assessment battery (FAB)|This test is a composite tool for assessing executive functions related to the frontal lobe.
15811598|NCT04353947|Diagnostic Test|Positive and Negative Affect Scale (PANAS)|It is a self-report questionnaire made up of 20 items (10 of positive affect and another 10 of negative affect) that the subject must answer, obtaining in this way a score in positive affectivity (AP subscale) and another in negative affectivity (AN subscale).
15811599|NCT04353947|Diagnostic Test|Auto-Assessment Manikins (SAM)|It is a self-report questionnaire that assesses the emotional response of the subject, in this case, through a mood induction task that plays different films scenes.
15811600|NCT04353921|Other|No intervention will be administered as part of this study.|No intervention will be administered as part of this study.
15811601|NCT04353908|Procedure|Rehabilitation|The Kabat procedure consists of facilitating the voluntary response of an impaired muscle through a global pattern of an entire muscular section which undergoes resistance. This method considers that harmony, coordination and optimal strength of body movements mainly depend upon the fact that they are performed following diagonal lines with respect to the sagittal axis of the body, thus implying a 'rotational' effect. It will performed twice a week for 8 weeks
15811602|NCT04353908|Procedure|Collagen Injection|With an insulin-type syringe and 30-gauge needle, a bolus of about 0.4 cc per point of the collagen solution will be injected in the orbicularis oculi muscle 1 cm outside the orbital rim and 0.5 cm superior and inferior to the first injection point, respectively, and in the orbicularis oris muscle, where the 2 injection points are on the border between the pars peripheralis and pars marginalis, located about 5 mm above the superior and inferior vermilion, respectively
15811603|NCT04353895|Device|Guidance for pedicle screw insertion (Mazor Stealth)|Using imaging devices and navigation for guidance, we perform a posterior vertebral fusion with pedicle screw insertion
15811604|NCT04353895|Device|Guidance for pedicle screw insertion (O-arm Navigation)|Using imaging devices and navigation for guidance, we perform a posterior vertebral fusion with pedicle screw insertion
15811605|NCT04353882|Other|Assess the difference in MOR-1 expression between healthy and tumor tissue|Assess the difference in the quantitative expression of MOR-1 (by means of RT-qPCR) between healthy tissue and tumor tissue, in patients with stage II and III colorectal cancer undergoing scheduled surgery.
15811606|NCT04353869|Biological|Bio collection|venous blood sampling and collection of urine
15811607|NCT04353856|Other|quality of life assessment|quality of life assessment using the EQ5D questionnaire once a month
15811940|NCT04351295|Drug|Chloroquine|chloroquine oral tablets
15811608|NCT04353830|Drug|IBI939|Several dose levels will be evaluated for IBI939 administered as a single agent and in combination with Sintilimab. IBI939 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit. Those who discontinue treatment with single-agent IBI939 may receive combination treatment with Sintilimab or IBI939+ Sintilimab. Combination treatment may continue until disease progression or loss of clinical benefit.
15811609|NCT04353830|Drug|IBI939+ Sintilimab|"IBI939: Several dose levels will be evaluated for IBI939 in combination with Sintilimab. IBI939 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit.
~Sintilimab: Sintilimab will be given as 200 mg via IV infusion on Day 1 of each 21-day cycle in combination with IBI939. Combination treatment may continue until disease progression or loss of clinical benefit."
15811610|NCT04353830|Drug|IBI939+ Sintilimab|"IBI939: IBI939 in combination with Sintilimab will be given with RP2D. IBI939 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit.
~Sintilimab: Sintilimab will be given as 200 mg via IV infusion on Day 1 of each 21-day cycle in combination with IBI939. Combination treatment may continue until disease progression or loss of clinical benefit."
15811611|NCT04353817|Drug|ELX/TEZ/IVA|Fixed-dose combination (FDC) tablet.
15811612|NCT04353817|Drug|IVA|Mono tablet.
15811613|NCT04353817|Other|Placebo|Placebo matched to ELX/TEZ/IVA.
15811614|NCT04353817|Other|Placebo|Placebo matched to IVA.
15811617|NCT04353791|Drug|OST-122|Active dose
15811618|NCT04353791|Drug|Placebo|Placebo
15811619|NCT04353778|Drug|Pyridostigmine|Eight weeks of low-dose pyridostigmine
15811620|NCT04353778|Drug|Placebos|matching placebo x 8 weeks
15811621|NCT04353778|Procedure|non-invasive vagal nerve stimulation|stimulation of the vagus nerve
15811622|NCT04353765|Drug|Cabozantinib monotherapy|Intervention description (FDA Label): kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma (RCC).
15811623|NCT04353765|Drug|All authorized TKI monotherapies in advanced RCC: sunitinib (Sutent), Pazopanib (Votrient), Axitinib (Inlyta); Lenvatinib (Lenvima) in combination with everolimus (Afinitor), sorafenib (Nexavar)|As per authorized FDA label in advanced RCC
15811624|NCT04353739|Behavioral|Self-Management for HIV-positive Asian Pacific Americans|Developed upon the results of our prior studies involving familial relations among APA HIV+ populations, the family-informed self-management intervention has been fully manualized and has eight modules: (1) psycho-education, (2) cognitive-behavioral management skills training, (3) preparation for disclosure, (4) family relations and support management, (5) anxiety and depressive symptom management, (6) brief mindfulness training, (7) symptom reduction, and (8) the Life-Steps program.
15811625|NCT04353726|Other|Weight management|During a 12-month period, participants will attend a total of 22 diet improvement sessions, each of which will last approximately 1 hour. Twelve sessions will be held in the first 5 months and will be focused on safe and efficient weight loss. The participants will learn to create a personalized weight loss diet from their kitchen based on their diet practice and food preference. The next 10 sessions will be held in the last 7 months and will be focused on weight maintenance and healthy eating. The participants will build skills to select foods and create meals that prevent them from overeating.
15811626|NCT04353713|Dietary Supplement|40% Dextrose Gel|Prophylactic administration of 40% dextrose gel via buccal mucosa to prevent newborn hypoglycemia
15811627|NCT04353713|Dietary Supplement|2% carboxymethylcellulose gel|placebo
15811628|NCT04353700|Behavioral|Yoga group|During the in-home yoga intervention, participants performed 30 to 50 minutes of yoga postures three to five times a week for 12 weeks, including 5 minutes of warm-up exercise, 15 to 30 minutes of dynamic flow yoga postures, 10 minutes of weight barring standing postures, and 5 minutes of cool-down. These in-home sessions were a repeat of what participants learned during the first week of training session at UML. We progressively increased the intensity of the home practice sessions by adding the number of sun salutation (SS) over the 12 weeks.
15811629|NCT04353687|Device|Robotic-assisted inguinal hernia repair|Each surgeon will perform the robotic-assisted inguinal hernia procedure per their standard practice. Surgeon subjects will consent to prospectively provide selected procedure and case data.
15811630|NCT04353674|Device|Control group|Patients randomized into this group will receive standard of care for COVID-19 infection
15811631|NCT04353674|Device|SLEDD with a L-MOD|Patients randomized to this group will undergo slow low efficiency daily dialysis for approximately 12 hours, 2 days in a row with a leukocyte modulatory device.
15811632|NCT04353661|Drug|Azithromycin|Azithromycin will be administered orally.
15811633|NCT04353661|Other|HP xenon (¹²⁹XE)|HP xenon (¹²⁹XE) will be administered at an approximate dose of 1 L or up to 25% of the Participant's total lung capacity followed by a breath hold of up to 15 seconds.
15811634|NCT04353635|Device|dolphin 3d|software
15811635|NCT04353622|Device|Exoskeleton robot for upper extremity|"Robot-assisted Treatment Program:
~10 minutes elbow flexion/extension
~10 minutes forearm supination/pronation
~10 minutes wrist flexion/extension
~10 minutes ulnar/radial deviation
~Frequency: 2/week Duration: 12 sessions (6 weeks)"
15811636|NCT04353622|Other|Conventional physiotherapy|Ferquency: 2/week Duration: 12 sessions (6weeks) Each session: 50 minutes
15811637|NCT04353596|Drug|ACE inhibitor, angiotensin receptor blocker|In patients randomized to stopping / replacing ACEI or ARB, it may be necessary to switch to another drug without direct effect on the RAS system. In patients, randomized to continuation, it may be needed to stop ACEI or ARB (e.g. hypotension with beginning sepsis) irrespective of the study.
15811638|NCT04353570|Other|clinical interview|This interview can be carried out face to face or remotely. In the latter case, it is part of telemedicine, which is recognised by the health authorities in France.
15811639|NCT04353544|Other|delayed cord clamping|delayed cord clamping
15811640|NCT04353531|Device|High-flow nasal cannula|High-flow nasal cannula is a modality of oxygen device that can provide gas flow meets or exceeds patient inspiratory flow demand (flow can be set at 10-60 L/min), it has been proven to improve oxygenation and reduce intubation rate in hypoxemic patients.
15812012|NCT04350736|Drug|TD-0903|Study drug to be administered by inhalation
15811642|NCT04353531|Procedure|bronchoscopy examination|is a procedure that allows a doctor to examine the inside of the lungs, including the bronchi, which are the main pathways into the lungs. During a bronchoscopy, a doctor inserts a thin tube containing a light and camera into the lungs through the nose or mouth or via artificial airway such as intubation or tracheotomy tube
15811643|NCT04353531|Procedure|intubation|Intubation is the process of inserting a tube, called an endotracheal tube (ET), through the mouth and then into the airway. This is done so that a patient can be placed on a ventilator to assist with breathing during anesthesia, sedation, or severe illness.
15811644|NCT04353531|Procedure|tracheostomy|A tracheostomy is a medical procedure - either temporary or permanent - that involves creating an opening in the neck in order to place a tube into a person's windpipe. The tube is inserted through a cut in the neck below the vocal cords. This allows air to enter the lungs.
15811645|NCT04353531|Device|nebulization|A nebulizer is a piece of medical equipment that a person with asthma or another respiratory condition can use to administer medication directly and quickly to the lungs
15811646|NCT04353531|Diagnostic Test|Pulmonary function test|Pulmonary function tests (PFTs) are noninvasive tests that show how well the lungs are working. The tests measure lung volume, capacity, rates of flow, and gas exchange.
15811647|NCT04353518|Drug|Suspension of heat killed (autoclaved) Mycobacterium w|Subjects randomized to Test arm will receive intraderma Mw in divided doses at least 2 cm away from first injection site in the deltoid region.
15811648|NCT04353518|Other|Placebo|Subjects randomized to placebo arm will receive intraderma Placebo in divided doses at least 2 cm away from first injection site in the deltoid region.
15811649|NCT04353505|Drug|Ketorolac|Intra-arterial delivery of Ketorolac in the internal maxillary artery, once
15811650|NCT04353505|Drug|Dexamethasone|Intra-arterial delivery of Dexamethasone in the internal maxillary artery, once.
15811651|NCT04353492|Biological|Ofatumumab|Patients in the ofatumumab will receive injections of ofatumumab provided in an autoinjector (AI) for subcutaneous administration containing 20 mg ofatumumab (50 mg/ml, 0.4 ml content)
15811652|NCT04353479|Drug|Camrelizumab(SHR-1210)|A humanized monoclonal immunoglobulin
15811653|NCT04353479|Drug|Decitabine|A DNA methyltransferase inhibitor
15811654|NCT04353466|Procedure|quantitative chemical shift imaging (QCSI)|"Poor scores of QCSI with Fat Fraction below the cut off point of 0.3 which is considered bone at risk"
15811655|NCT04353466|Drug|Elelyso|intravenous (IV) infusions of Elelyso
15811656|NCT04353453|Device|Study Procedure for Participants That Were Not in the Driving Group|"Subjects were fitted with One lead Holter monitor and the CardiacSense1 watch simultaneously and were tested in the following condition:
~Sitting down for 10 minutes, walking for one minute and repeat this sequence twice at Indoor 28 ±3 degree Celsius.
~Sitting down for 10 minutes, walking for one minute and repeat this sequence twice at Indoor 22 ±3 degree Celsius.
~Sitting down for 10 minutes,outdoor walking for one minute and repeat this sequence four times At the end the devices were removed from the subject by the medical staff.The recorded data was downloaded for analysis by the Sponsor"
15811657|NCT04353453|Device|Study Procedure for Participants That Were Included in the Driving Group|"Subjects were fitted with One lead Holter monitor and the CardiacSense1 watch simultaneously and were tested in the following condition:
~Sitting down for 10 minutes, walking for one minute and repeat this sequence twice at Indoor 28 ±3 degree Celsius.
~Sitting down for 10 minutes, walking for one minute and repeat this sequence twice at Indoor 22 ±3 degree Celsius.
~Going from the indoor facility to the car and driving for 30 minutes at least. Subject drove the car in city streets under light traffic conditions. At the end the devices were removed from the subject by the medical staff.The recorded data was downloaded for analysis by the Sponsor"
15811658|NCT04353427|Behavioral|The Seven Pathways to Healing, Health and Wellness curriculum|"The curriculum seeks to increase civic engagement by fostering a sense of community and a sense of social and personal responsibility in community. There will be 7 monthly session that will be approximately 1 hour in duration. Session topics include:
~Education and Information (including mental health awareness, and a one-day certificate program in Mental Health First Aid)
~Connection with Others
~The Body as Temple
~Emotional Healing
~The Nature of Mind
~Life Assessment
~The Nature of Spirit"
15811659|NCT04353414|Procedure|Transmuscular Quadratus Lumborum Block|Transmuscular Quadratus Lumborum Block (TQLB) is a relatively new block that targets thoracic and lumbar nerves. The decrease in sensation means a decrease in pain. The TQL block will be preformed in addition to an incision-site injection (on hip), called pericapsular injection. The potential risks associated with the Transmuscular Quadratus Lumborum Block (TQLB) include nerve damage and infection at injection site. In addition, there can be temporary sensory and motor loss, depending on the dosage, site of injection and duration of the nerve block. However, the amount (30mL) used in this study meets FDA dosage-regulations for this medication.
15811660|NCT04353414|Procedure|Pericapsular injection|Pericapsular injection (PCI) of 20 mL of 0.25% Bupivacaine HCL (numbing medication) into the incision-site (hip portal sites) to decrease sensation. The potential risks associated with the pericapsular injection include bleeding, infection at injection site and local anesthetic toxicity however, the likelihood is low due to the expertise of the surgeon preforming the injection and the sterile environment and good clinical practice from clinicians, which reduces the likelihood of infection.
15811661|NCT04353414|Drug|Bupivacaine Hydrochloride|Bupivacaine used for this study is the standard of care for both TQLB and PCI. Pericapsular injection (PCI) contains 10 mL of 0.25% Bupivacaine HCL which will be injected through the anterolateral portal while the additional 10 mL will be injected through the mid-anterior portal.
15811662|NCT04353388|Diagnostic Test|CBC-DIFF Monocyte Volume Width Distribution (MDW)|MDW measurement will be used to detect sepsis. Results will not be used to manage patients.
15811663|NCT04353375|Drug|HMPL-453|HMPL-453 150mg QD
15811664|NCT04353362|Drug|Ofloxacin|400 mg, 1 time per day for 5 days
15811665|NCT04353362|Drug|Amoxicillin|500 mg, 3 times per day for 7 days
15811666|NCT04353362|Drug|Metronidazole|500 mg, 3 times per day, for 7 days
15811667|NCT04353336|Drug|Chloroquine or Hydroxychloroquine|Chloroquine or Hydroxychloroquine
15811668|NCT04353323|Other|Blood sampling|3 blood samples (D0, D15 and D30) will be taken from each participant
15811669|NCT04353310|Drug|Curcumin|Curcumin 1500mg PO BID
15811670|NCT04353310|Other|Placebo|identical in appearance to curcumin
15812013|NCT04350736|Drug|Placebo|Placebo to be administered by inhalation
15811671|NCT04353297|Other|EEG-based BCI system for (hand) Motor Imagery training|The Promotoer is an all-in-one BCI-supported motor imagery (MI) training station, equipped with a computer, a commercial wireless Electroencephalography (EEG)/ Electromyography (EMG) system, a screen for therapist feedback (EEG and EMG activity monitoring) and screen for the real-time ecological feedback to patient - a custom software program that provides a for (personalized) visual representation of the patient's own hands. As such, this software allows the therapists to create an artificial reproduction of a given patient's hand/forearm by adjusting a digitally created image in shape, size, skin colour and orientation to match as much as possible the real patient hand/forearm. Training consists of the MI tasks only of the affected hand, grasping or finger extension in separate runs. The trial length will include a constant baseline period of 4 sec and a task period of maximally 10 sec for BCI intervention group. Each training session will consist of 4 runs (20 trials each).
15811672|NCT04353297|Other|Motor Imagery training|Training consists of MI tasks only of the affected hand, grasping or finger extension in separate runs. MI training will be delivered without BCI support (ie., the Promotoer system will not provide real-time feedback of MI performance; hand/forearm visual representation will remain standstill) with a dose/setting regimen equivalent to EXP intervention. The trial length will include a constant baseline period of 4 sec and a task period of maximally 4 sec. Each training session will consist of 4 runs (20 trials each).
15811673|NCT04353284|Drug|Camostat Mesilate|Camostat mesilate 200mg taken orally, 4 times daily, for 7 days.
15811674|NCT04353284|Other|Placebo|Placebo taken orally, 4 times daily, for 7 days.
15811675|NCT04353271|Drug|Hydroxychloroquine|Hydroxychloroquine 800 mg initial dose then 6-8 hours later HCQ 600 mg, then 200 mg three times per day for 4 days.
15811676|NCT04353271|Other|Placebo|Placebo take 4 tabs, then 6-8 hours later take 3 tabs, then take 1 tab three times per day for 4 days.
15811677|NCT04353258|Behavioral|Behavioral Economics intervention (BE mHealth)|Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth) that includes behavioral economics components.
15811678|NCT04353258|Behavioral|Standard mHealth intervention (mHealth)|Participants will receive a 12-month behavioral weight loss intervention delivered primarily via mobile phone (mHealth).
15811679|NCT04353245|Other|BIOMARKERS IN THE LONG TERM IMPACT OF CORONAVIRUS INFECTION IN THE CARDIORRESPIRATORY SYSTEM|Organize care follow-up for patients who have had COVID-19 coronavirus infection for scientific purposes. Thus, it is expected to obtain relevant data on cardiac sequelae and pulmonary. These data are important for understanding the long-term prognosis of patients surviving this infection.
15811680|NCT04353219|Device|compression stocking|participants will continue their training program as prepared by their coach with compression stocking
15811681|NCT04353219|Other|control|participants will continue their training program as prepared by their coach without compression stocking
15811682|NCT04353206|Biological|Multiple Doses of Anti-SARS-CoV-2 convalescent plasma|Subjects to receive single or double plasma units infused on day 0 and potentially days 3 and 6.
15811683|NCT04353193|Drug|Terlipressin|Terlipressin 1mg IV bolus
15811684|NCT04353193|Drug|Terlipressin|Terlipressin by IV continuous infusion at a rate of 2mg/day (max 4mg/day) during 2 hours
15811685|NCT04353193|Drug|Octreotide|Octreotide 50mcg IV bolus plus continuous infusion at a rate of 50mcg/h during 2 hours
15811686|NCT04353180|Drug|Drug Isotretinoin (13 cis retinoic acid ) capsules+standard treatment|"After three days of randomization and standard treatment , 13 cis retinoic acid (0.5 mg/kg/day in 2 divided doses orally for 14 days.+standard treatment
~Standard treatment is according to the protocol of treatment of 2019-nCoV infection"
15811687|NCT04353180|Drug|Isotretinoin(Aerosolized 13 cis retinoic acid) +standard treatment|"Drug: After three days of randomization and standard treatment , Aerosolized 13 cis retinoic acid in gradual two doses increase froms 0.2 mg/kg/day to 4 mg/kg/day as inhaled 13 cis retinoic acid therapy for 14 days +standard treatment
~Standard treatment is according to the protocol of treatment of 2019-nCoV infection"
15811688|NCT04353180|Drug|Isotretinoin (13 cis retinoic acid ) capsules|13 cis retinoic acid (0.5 mg/kg/day in 2 divided doses orally for 14 days
15811689|NCT04353180|Drug|Aerosolized 13 cis retinoic acid|Aerosolized 13 cis retinoic acid in gradual two doses increase froms 0.2 mg/kg/day to 4 mg/kg/day as inhaled 13 cis retinoic acid therapy for 14 days
15811690|NCT04353180|Drug|Standard treatment|Standard treatment is according to the protocol of treatment of 2019-nCoV infection
15811691|NCT04353167|Other|observational evaluation|Patients will be evaluated only observationally without intervention
15811692|NCT04353154|Diagnostic Test|Spartan Cube Point-of Care Covid-19 test|Throat and nasal swab for COVID-19 point-of-care test.
15811693|NCT04353141|Diagnostic Test|standardized Lung Ultrasound (LUS) examination|14 areas (three posterior, two lateral and two anterior) will be assigned a COVID-LUS score: Score 0 (Normal pattern), Score 1 (Pattern of mild disease), Score 2 (Pattern of moderate disease), Score 3 (Pattern of severe disease). Classification of LUS result: LUS NEGATIVE: Group A = Score 0 in all 14 areas OR score =1 in areas of one site (right or left). It means that score 1 is pathological only when present bilaterally; LUS POSITIVE: both group B and C have to be considered positive: Group B (MILD DISEASE) = Score 1 in at least two areas localized bilaterally and no areas with score >1; Group C (MODERATE/SEVERE DISEASE)= Score >2 in at least two areas localized bilaterally
15811694|NCT04353128|Drug|Melatonin 2mg|2 mg of prolonged release melatonin tablets per os (P.O.) before bedtime for 12 weeks
15811695|NCT04353128|Drug|Placebo oral tablet|Identically looking placebo tablets P.O. before bedtime for 12 weeks
15811696|NCT04353115|Device|Training with Serious game|training the gaze stability with a serious game, 20 minutes a day, 2 days a week for 5 weeks in the presence of a doctor or physiotherapist, at the hospital to avoid addiction at home.
15811697|NCT04353102|Drug|YH002|YH002 will be administered intravenously every three weeks (Q3W) for up to 2 years at doses of Dose A, Dose B, Dose C, Dose D, Dose E, Dose F, Dose G, and Dose H.
15811698|NCT04353089|Other|Basic life support courses|4 hours certified basic life support courses
15811699|NCT04353076|Other|Simulated heatwave exposure|Young and older adults (no cooling) are exposed to a 9-hour simulated exposure.
15811700|NCT04353076|Other|Simulated heatwave exposure with mid-day cooling|Older adults (cooling) are exposed to a 9-hour simulated exposure with mid-day ambient cooling.
15811828|NCT04352088|Procedure|Nasal provocation test|Allergen extract under controlled conditions will be applied into nasal mucous.
15811701|NCT04353063|Behavioral|Multidisciplinary care with a personalized care|During the 4-week intervention, participants will be given stickers by the research assistant to increase their motivation to walk. A sticker will be given once a participant reaches a daily walking-time goal. The number of stickers participants receive depends on the number of days they reach their daily goals. The stickers can be redeemed for the participant's choice of gift in the gift shelf of the ward or on a gift card. A final assessment will be conducted at week 4. The participant will be reminded that the ActiGraph and the post-test questionnaires will be picked up at the end of week 4
15811702|NCT04353050|Procedure|Non-invasive adhesive system (patch)|The already registered on the market adhesive skin patch will be applied and removed for several times on the pigmented skin (or mucosal) lesion just before the preplanned excisional biopsy after local anaesthesia have been already administered. Excisional biopsy and local anaesthesia are not the part of this study and will be carried out according to local practice
15811705|NCT04353024|Drug|Dimethyltryptamine (DMT)|Intravenous DMT bolus and/or DMT maintenance perfusion over 90 min
15811706|NCT04353024|Drug|Saline|Intravenous saline bolus and/or saline maintenance perfusion over 90 min
15811707|NCT04353011|Other|questionnaire assesment|questionnaire assesment
15811708|NCT04352998|Dietary Supplement|One dose pre-workout condition|one dose of a multi-ingredient pre-workout supplement
15811709|NCT04352998|Dietary Supplement|Two dose pre-workout condition|two doses of a multi-ingredient pre-workout supplement
15811710|NCT04352998|Dietary Supplement|Placebo condition|one dose of a placebo
15811711|NCT04352985|Device|Toraymyxin PMX-20R (PMX Cartridge)|The intervention is two (2) treatment sessions of PMX cartridge administration within approximately 24 hours of each other. Each treatment session will target 2 hours with a minimum of 1 ½ hours, at a flow rate of approximately 100 mL/minute, (range of 80 to 120 mL/minute). In cases where the clinical status of the subject is improving, or if the subject suffers from a relapse and the treating physician believes an additional PMX treatment may improve the clinical outcome of the subject, they may administer an additional PMX treatment session (for a total of 3 treatment sessions) at their discretion. All subjects will continue to receive standard medical care for COVID 19 and septic shock.
15811712|NCT04352972|Device|Tele-monitored home exercise program|Tele-monitoring home exercise program used in the home with monitoring by physiotherapists.
15811713|NCT04352972|Other|Hospital-based rehabilitation program|Participants will receive a maximum of 8 sessions over 10 weeks with the option of two additional sessions. Participants will receive exercises, patient education, manual therapy and other modalities that were prescribed and progressed at the project physiotherapist's discretion. Participants will also receive a set of home exercises and they will be instructed to exercise on days when not attending rehabilitation.
15811714|NCT04352959|Device|mouthrinse with bêta-cyclodextrin and citrox|3 daily mouthrinses for 7 days
15811715|NCT04352959|Device|mouthrinse without bêta-cyclodextrin and citrox|3 daily mouthrinses for 7 days
15811716|NCT04352946|Drug|Hydroxychloroquine Pre-Exposure Prophylaxis|HCQ PreP 400mg daily
15811717|NCT04352946|Drug|Placebo oral tablet|Placebo tablets 400mg daily
15811718|NCT04352933|Drug|Hydroxychloroquine - Daily dosing|"Active HCQ:
~Days 1-2: Loading phase - 400mg (2 x 200mg capsules) taken TWICE A DAY for 2 days Days 3 onwards: Maintenance Phase - 200mg (1 x 200mg capsule) taken ONCE A DAY, every day for 90 days (~3 months),
~Matched Placebo HCQ:
~Days 3 onwards: Maintenance Phase - 2 capsules taken ONCE A WEEK on the same day each week (every 7th day) for 90 days (~3 months)"
15811719|NCT04352933|Drug|Hydroxychloroquine - Weekly Dosing|"Active HCQ:
~Days 1-2: Loading Phase - 400mg (2 x 200mg capsules) taken TWICE A DAY for 2 days Days 3 onwards: Maintenance Phase - 400mg (2 x 200mg capsules) taken ONCE A WEEK on the same day each week (every 7th day) for 90 days (~3 months)
~Matched Placebo HCQ:
~Days 3 onwards: Maintenance Phase - 1 capsule taken ONCE A DAY for 90 days (~3 months)"
15811720|NCT04352933|Other|Matched Placebo Hydroxychloroquine|"Matched placebo HCQ - daily dosing:
~Days 1-2: Loading Phase - 2 capsules taken TWICE A DAY for 2 days Days 3 onwards: Maintenance Phase - 1 capsule taken ONCE A DAY for 90 days (~3 months) Matched placebo HCQ - weekly dosing Days 3 onwards: Maintenance Phase - 2 capsules taken ONCE A WEEK on the same day each week (every 7th day) for 90 days (~3 months)"
15811721|NCT04352920|Other|Experimental group|PHYSIUM System® provides standardized negative pressure massage for 15 minutes with the analgesic program and 15 minutes with the trigger points program at 80 millibars with eight adjustable arms both in the entire muscle and in muscle fibrosis.
15811722|NCT04352907|Device|Continuous Glucose Sensor|Continuous glucose sensor results will be compared with arterial glucose samples
15811723|NCT04352894|Diagnostic Test|Fluorescence guided peritoneal exploration|Intravenous injection of ICG
15811724|NCT04352881|Other|Questionary patient|Assessing pain reduction using a 4-step questionary
15811725|NCT04352868|Device|Intelliwave multifocal, toric, soft contact lens|This is a quarterly disposable, multifocal, toric soft contact lens commercially available from Art Optical Contact Lens, Inc.
15811726|NCT04352868|Device|Intelliwave toric, soft contact lens|This is a quarterly disposable toric soft contact lens commercially available from Art Optical Contact Lens, Inc.
15811727|NCT04352855|Drug|Ceftolozane/tazobactam|Administration
15811728|NCT04352842|Other|Echocardiography|An expert with 17-year professional experience performed all the echocardiography examinations using a GE LOGIQTM e portable color ultrasound diagnostic machine (GE Healthcare, WI, USA) that was specially used in the contaminated area. Two-dimensional and Doppler echocardiographic measurements were conducted following the recommendations of the American Society of Echocardiography
15811729|NCT04352829|Other|VIDEO-TRAINING-SESSION ABOUT MDI USE|The steps were demonstrated with the brochure that illustrated correct inhalation techniques and were prepared by Turkish Respiratory Research Society-Inhalation Treatment Study Group in line with the literature and were described with a video that was designed by Turkish National Society of Allergy and Clinical Immunology (25). The video is provided with a free access on the webpage of Turkish National Society of Allergy and Clinical Immunology.The video included images that explained the steps about what to do before MDI use, how to use the device and the issues to which attention should be paid during the use of the device and focused on the skill-steps that should gradually be performed about MDI use.
15811902|NCT04351555|Drug|Osimertinib|Oral
15811730|NCT04352816|Device|Magnetocardiogram|Magnetocardiography (MCG) is a non-invasive, non-contact body-surface method which uses magnetometers to measure and map the magnetic fields generated by the electrical activity within the heart. It offers a better spatial resolution than an ECG recording and opens the possibility of detecting conduction characteristics consistent with arrhythmogenesis.9-15 The application of MCG has been limited by feasibility as devices up to now have been based on superconducting quantum interference devices (SQUID) with supercooled sensors. These machines were often operated in a shielded environment, to decrease magnetic field interference (noise) from electrical devices and other sources of magnetic fields. This was a major limiting factor in deploying these devices in a working environment especially considering, that most hospital wards will have numerous devices that can interfere with the device.
15811731|NCT04352803|Biological|Autologous Adipose MSC's|Autologous Adipose Derived Mesenchymal Cells 500,000/kg IV
15811732|NCT04352777|Drug|Abemaciclib|50 - 150mg tablet BID as prescribed per standard of care
15811733|NCT04352777|Drug|Fulvestrant|500mg as prescribed per standard of care
15811734|NCT04352777|Drug|Aromatase Inhibitors|Letrozole, anastrozole as prescribed per standard of care
15811735|NCT04352764|Diagnostic Test|CoronaCideTM COVID-19 IgM/IgG Rapid Test and Premier Biotech COVID-19 IgM/IgG Rapid Test|The tests are being distributed under section IV.D of the current United States Food and Drug Administration (FDA) policies for diagnostic tests for coronavirus disease 2019. The test is available under an emergency access mechanism called an Emergency Use Authorization (EUA). The EUA is supported by the Secretary of Health and Human Service's (HHS's) declaration that circumstances exist to justify the emergency use of in vitro diagnostics (IVDs) for the detection and/or diagnosis of the virus that causes COVID-19
15811736|NCT04352751|Other|convalescent plasma|"Plasmapheresis, 900 - 1000 mL each time.
~Standard apheresis plasma collection protocol using Haemonetics MCS+ intermittent blood flow system or Terumo Optia, Cobe-Spectra, Trima or Fresenius continuous flow system to be used.
~Isovolumic saline replacement should be done.
~Each donor can donate convalescent plasma again after an interval of every 2 weeks"
15811737|NCT04352738|Diagnostic Test|Multiparametric, multinuclear MR (DMI/ 13C-MRS/ GlycoCEST/GlycoNOE)|Magnetic resonance scanning for 150 minutes involving ingestion of 60g of 6,6, 2H2-glucose diluted in 200ml of tap water. Frequent blood samples will be drawn for measurements of plasma glucose, insulin, C-peptide and glucagon
15811738|NCT04352725|Procedure|End-expiratory lung volume measurement and incremental PEEP titration|"End expiratory lung volume measurement procedure according to the PEEP level set by the clinician, respecting a Vt at 6ml/kg IBW and Pplat<28cmH2o
~incremental PEEP titration procedure in 5 steps starting from 5cmH2o up to 20cmH2o"
15811739|NCT04352712|Other|blood sampling|blood sampling
15811740|NCT04352686|Drug|Buspirone|Administration of buspirone to assess esophageal sensitivity
15811741|NCT04352686|Drug|Placebo|Administration of placebo to assess differences in esophageal sensitivity
15811742|NCT04352673|Diagnostic Test|Elbow flexion and extension strength measurements using a hand-held dynamometer|Elbow flexion and extension strength of the participants will be measured in both arms in the supine, prone, and sitting positions using a hand-held dynamometer.
15811743|NCT04352660|Drug|Mitomycin-C injection|MMC delivered by preoperative subconjunctival injection
15811744|NCT04352660|Drug|Mitomycin-C sponge|MMC delivered by intraoperative direct scleral application with impregnated cellulose sponges
15811745|NCT04352647|Behavioral|female athletes|The type of incontinence is assessed, whether there are risk factors and quality of life and psychological performance
15811746|NCT04352634|Other|Exposure to the SARS-CoV-2 and its consequences|This is an observational design. Participants are exposed to the SARS-CoV-2, the Covid-19 pandemic, and/or its consequences
15811747|NCT04352621|Drug|intranasal ketamine|Ketamine 0.5 mg/kg will be administered intranasally using an atomization device with a maximum dose of 40 mg followed by 6 weeks of rTMS treatment. .
15811748|NCT04352621|Device|rTMS treatment|patients will begin the open label trial of rTMS per the FDA-approved method on day 1 (the day after the Baseline Visit).
15811749|NCT04352608|Biological|Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule|Two doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,14,and one dose of booster immunization with medium dosage (600SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,14 in phaseⅡ.
15811750|NCT04352608|Biological|Two doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule|Two doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,14 and one dose of booster immunization with high dosage (1200SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,14 in phaseⅡ.
15811751|NCT04352608|Biological|Two doses of placebo at the emergency vaccination schedule|Two doses of placebo at the schedule of day 0,14 and one dose of booster immunization with placebo 6 months after the schedule of day 0,14 in phaseⅡ.
15811752|NCT04352608|Biological|Two doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule|Two doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,28 and one dose of booster immunization with medium dosage (600SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,28 in phaseⅡ.
15811753|NCT04352608|Biological|Two doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule|Two doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,28 and one dose of booster immunization with high dosage (1200SU/0.5ml) experimental vaccine 6 months after the schedule of day 0,28 in phaseⅡ
15811754|NCT04352608|Biological|Two doses of placebo at the routine vaccination schedule|Two doses of placebo at the schedule of day 0,28 and one dose of booster immunization with placebo 6 months after the schedule of day 0,28 in phaseⅡ.
15811755|NCT04352608|Biological|Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule|Three doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,14,42
15811756|NCT04352608|Biological|Three doses of high dosage inactivated SARS-CoV-2 vaccine at the emergency vaccination schedule|Three doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,14,42
15811757|NCT04352608|Biological|Three doses of placebo at the emergency vaccination schedule|Three doses of placebo at the schedule of day 0,14,42
15811758|NCT04352608|Biological|Three doses of medium dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule|Three doses of medium dosage (600SU/0.5ml) experimental vaccine at the schedule of day 0,28,56
15811759|NCT04352608|Biological|Three doses of high dosage inactivated SARS-CoV-2 vaccine at the routine vaccination schedule|Three doses of high dosage (1200 SU/0.5ml) experimental vaccine at the schedule of day 0,28,56
15811760|NCT04352608|Biological|Three doses of placebo at the routine vaccination schedule|Three doses of placebo at the schedule of day 0,28,56
15811761|NCT04352595|Drug|Hemay808|Hemay808 is a onitment of Hemay028, a small molecule PDE4 inhibitor.
15811762|NCT04352582|Other|Survey|Survey
15811764|NCT04352543|Behavioral|Active Video Game Exercise|Play during 30 minutes in the easy level
15811765|NCT04352543|Behavioral|Treadmill walking exercise|30 minutes (65 - 75% heart rate maximal)
15811766|NCT04352543|Behavioral|Sedentary Behavior|Quiet Rest: 30 minutes
15811767|NCT04352530|Other|Health Communication|Spoken word poems set to images performed by youth who wrote the poems. Videos were produced by The Bigger Project and were posted publicly to the Bigger Picture Project website and YouTube. Duration of videos ranges from 2 minutes to 6 minutes.
15811768|NCT04352517|Other|Online Survey|Online survey completion through google app.
15811769|NCT04352504|Other|Almond|Consume 1.5 oz. serving almonds (246 calories) daily for 12 weeks
15811770|NCT04352504|Other|Pretzel|Consume 2 oz. serving of pretzels (216 calories) daily for 12 weeks
15811771|NCT04352491|Other|No intervention|No intervention
15811772|NCT04352478|Diagnostic Test|Histopathological result|Incidental gallbladder cancer and other pathology
15811773|NCT04352465|Drug|Methotrexate|Phase A: Subjects will be dosed 20 mg of MTX IV, once per week (total of 4 doses).
15811774|NCT04352465|Drug|Methotrexate|Phase B: Subjects will be dosed 30 mg of MTX IV, once per week (total of 4 doses).
15811775|NCT04352465|Drug|Methotrexate|Phase C: Subjects will be dosed 40 mg of MTX IV, once per week (total of 4 doses).
15811776|NCT04352452|Procedure|laparoscopic surgery|differences in musculoskeletal and cognitive stress
15811777|NCT04352439|Drug|Aspirin|81 mg aspirin daily
15811778|NCT04352426|Other|Exercise Test|Tests were conducted to evaluate exercise capacity.
15811779|NCT04352413|Drug|PLM60|Administration: Intravenous infusion
15811780|NCT04352400|Drug|Nafamostat Mesilate|administered intravenously as a continuous infusion
15811781|NCT04352400|Drug|Placebo|administered intravenously as a continuous infusion
15811782|NCT04352387|Behavioral|Montessori Method for Dementia|The Montessori Method highlights the importance of considering the past experiences, identifying interests and maximizing spared capacity and abilities of each individual.
15811783|NCT04352387|Behavioral|Usual care|Activities delivered regularly in the usual care, such as reading out newspapers, physical activities, and watching videos, in the 1-hour sessions.
15811784|NCT04352374|Other|Aerobic exercise|a Low-Intensity Aerobic Exercise with Borg scale RPE at 11.
15811785|NCT04352374|Device|Device guided breathing|The device consists of a control box, headphones and a respiratory rate monitor attached as a sensor belt around the user's chest.
15811786|NCT04352361|Drug|TVB-2640|TVB-2640 tablets (25mg/50mg/75mg) one tablet at a time, once per day.
15811787|NCT04352361|Drug|Placebo|Oral, matching number of placebo Tablets with active arm.
15811788|NCT04352348|Other|blood samples|"All arms:
~1 blood sample at inclusion (T0)
~COVID-19 positive, severe only:
~1 blood sample at D3, at D7, in case of transfer to intensive care unit or in case of aggravation of symptoms, eventually, at discharge from hospital if the last blood sample was more than 3 days old, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization.
~Follow-up after COVID-19 hospitalization only:
~1 blood sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization"
15811789|NCT04352348|Other|feces samples (COVI-BIOME ancillary study)|"All arms:
~1 feces sample at inclusion (T0)
~COVID-19 positive, severe only:
~1 feces sample at D3, at D7, in case of transfer to intensive care unit or in case of aggravation of symptoms and, eventually, at discharge from hospital"
15811790|NCT04352348|Other|sweat samples (COVIDOG ancillary study)|"All arms:
~2 sweat samples at inclusion (T0)"
15811791|NCT04352348|Other|saliva samples|"All arms:
~1 saliva sample at inclusion (T0)
~COVID-19 positive, severe only:
~1 saliva sample at D7, at discharge from hospital, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization.
~Follow-up after COVID-19 hospitalization only:
~1 blood sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization"
15811792|NCT04352348|Other|6 minutes walk test|"COVID-19 positive, severe only:
~6 minutes walk test in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization.
~Follow-up after COVID-19 hospitalization only:
~6 minutes walk test at inclusion (T0) and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization."
15811793|NCT04352348|Other|Phone call|"All arms except COVID-19 negative:
~1 phone call 3 months after COVID-19 infection.
~All arms except COVID-19 negative:
~1 phone call 6 months after COVID-19 infection.
~All arms except COVID-19 negative:
~1 phone call 12 months after COVID-19 infection."
15811794|NCT04352348|Other|Urine samples|"All arms:
~1 urine sample at inclusion (T0)
~COVID-19 positive, severe only:
~1 urine sample at D3, at D7, at discharge from hospital, in case of post-COVID-19 follow-up visit scheduled in standard care at 3 to 6 months after hospitalization and in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization.
~Follow-up after COVID-19 hospitalization only:
~1 urine sample in case of post-COVID-19 follow-up visit scheduled in standard care at 11 to 13 months after hospitalization"
15811795|NCT04352322|Dietary Supplement|A+HA(tm)|oral solution of hyaluronic acid mixture in combination with glucosamine and chondroitin
15811796|NCT04352322|Dietary Supplement|Placebo|oral solution with no active ingredients
15811827|NCT04352101|Drug|Escitalopram|Participants will take 10mg/d of escitalopram for two weeks, then the dose will be increased to 20mg/d, as tolerated, for the remaining 6 weeks of the study.
15811797|NCT04352296|Procedure|Individualized blood pressure|Individualized blood pressure management during mechanical thrombectomy with the administration of diluted norepinephrine (5-10 µg/ml) or nicardipine (1 mg/ml) or urpidil (5 mg/ml) to maintain the MAP within 10% of the first MAP measured in the angiography suit
15811798|NCT04352296|Procedure|Standard blood pressure|Standard blood pressure management based on international guidelines: Treatment of hypotension defined by a systolic blood pressure <140 mm Hg, and treatment of hypertension defined by a systolic blood pressure > 180 mm Hg or diastolic blood pressure >105 mm Hg) with usual treatments (norepinephrine, ephedrine or phenylephrine for hypotension; intravenous nicardipine or uradipil for hypertension).
15811799|NCT04352283|Device|Preprocedural ultrasound exam of lumbar spine|Preprocedural ultrasound exam of lumbar spine used to determinate needle puncture site
15811800|NCT04352270|Other|AD printed educational materials|Printed educational materials in Spanish and English about coping with Atopic Dermatitis, specifically geared towards children and parents will be given to participants.
15811801|NCT04352270|Other|AD educational videos|Short, educational videos in English and Spanish about coping with Atopic Dermatitis, specifically geared towards children and parents will be developed. There will be Spanish and English versions of the videos, minimal text, comprehensive language, animations, and it will be administered via user friendly platforms or websites.
15811802|NCT04352257|Radiation|pelvic Ultrasound|pelvic and transrectal ultrasound
15811803|NCT04352244|Procedure|Fat biopsy|"The fat biopsy is performed during a scheduled procedure at the Beth Israel Deaconess Medical Center (BIDMC). Routine preoperative procedures will be followed, including local anesthesia (numbing a particular region of the body) or general anesthesia (being put to sleep).
~Adipose tissue will be sampled from different depots depending on the procedure. For example, the surgeon will collect adipose tissue from the neck and supraclavicular depots from cervical spine, thyroid, and parathyroid procedures; perinephric fat from adrenalectomies, omental fat from abdominal procedures, and paraspinal fat from lumbar spine procedures. Up to 5 pieces of fat tissue weighing about three to six grams will be removed. All other aspects of the surgical procedure will proceed as planned. Samples will be prepared for subsequent laboratory analysis."
15811804|NCT04352244|Diagnostic Test|Blood sampling|A blood sample will be collected in the fasting state either during preoperative testing or in the preoperative area on the day of planned procedure for measurement of adipose functional markers (leptin, adiponectin) and insulin resistance (insulin, C-peptide), and measures of glycemia (glucose, hemoglobin A1c).
15811805|NCT04352244|Genetic|Blood sample for DNA analysis|Targeted resequencing of DNA to identify variants associated with adipose phenotypes will be performed.
15811806|NCT04352231|Dietary Supplement|High Fiber Diet Intervention|Plant-based diet with a targeted quantity of 35 g of dietary fiber per day, from a variety of fiber types. Each meal will be balanced to provide all essential nutrients and portions will be of adequate size to ensure participants are satiated. Participants on both diet interventions will be given multivitamin supplements in order to ensure they are receiving essential vitamins and minerals.
15811807|NCT04352231|Dietary Supplement|Low Fiber Diet Intervention|Animal based diet (meat, dairy) with a targeted quantity of 10 g of dietary fiber per day. Each meal will be balanced to provide all essential nutrients and portions will be of adequate size to ensure participants are satiated. Participants on both diet interventions will be given multivitamin supplements in order to ensure they are receiving essential vitamins and minerals.
15811808|NCT04352218|Device|"PTA + Stenting using Petalo stent"|PTA and Petalo's Stenting are a minimally invasive endovascular procedures, performed by a percutaneous access to the common femoral vein under local anesthesia and Duplex Ultrasound Guidance.
15811809|NCT04352218|Procedure|Percutaneous Transluminal Angioplasty (PTA)|PTA is a minimally invasive endovascular procedure, performed by a percutaneous access to the common femoral vein under local anesthesia and Duplex Ultrasound Guidance.
15811810|NCT04352205|Drug|Bortezomib|Given SC
15811811|NCT04352205|Biological|Daratumumab|Given IV
15811812|NCT04352205|Drug|Dexamethasone|Given PO and IV
15811813|NCT04352205|Drug|Lenalidomide|Given PO
15811814|NCT04352205|Drug|Thalidomide|Given PO
15811815|NCT04352192|Other|Kinesiotaping|For kinesiotaping, the elbow positioned in 30°-45° flexion and kinesiotaping facilitation technique is applied origin to insertion of biceps brachii muscle.
15811816|NCT04352179|Behavioral|Virtual Education Simulation|"The simulations will be developed using Kognito's proprietary Conversation Platform.
~In this pilot study, the simulations will be a bundle of four topic-based conversations with Linda, a virtual peer with a chronic disease. The four wellness topics are:
~Fitness & Nutrition
~Smoking Cessation
~Alcohol Use
~Distress & Anxiety"
15811817|NCT04352166|Drug|extended-release buprenorphine (BXR)|Three monthly injections will be provided during the course of the 12 week trial.
15811818|NCT04352166|Drug|sublingual buprenorphine (BSL)|On a weekly basis patients will be provided with sublingual buprenorphine to take up to 24 mg daily.
15811819|NCT04352153|Drug|Febuxostat|Febuxostat is taken at a dose of 20 mg once a day. During the medication period, the urine pH of each subject is monitored and recorded in the morning, noon and night.
15811820|NCT04352153|Drug|Uralyt-U|Febuxostat is taken at a dose of 20 mg once a day, potassium sodium hydrogen citrate granules 7.5 g / day, 2.5 g / per time, three times a day. During the medication period, the urine pH of each subject is monitored and recorded in the morning, noon and night.
15811823|NCT04352114|Drug|LY3461767 - SC|Administered SC.
15811824|NCT04352114|Drug|LY3461767 - IV|Administered IV.
15811825|NCT04352114|Drug|Placebo - SC|Administered SC.
15811826|NCT04352101|Drug|Bupropion XL|Participants will take 150 milligrams per day (mg/d) of bupropion XL for two weeks, then the dose will be increased to 300mg/d, as tolerated, for the remaining 6 weeks of the study.
15811829|NCT04352075|Drug|Autologous biologic drug of innovative therapy /cell therapy drug|Articular knee injection of microfat associated with a dose of 3 billions of platelets or associated with a dose of 1 billion of platelets or with saline solution
15811830|NCT04352062|Drug|Melatonin|
15811831|NCT04352062|Other|placebo|
15811832|NCT04352062|Drug|Pantoprazole 40mg|pantoprazole 2 x 40mg
15811833|NCT04352062|Drug|Amoxicillin|Amoxicillin 2 x 1000mg
15811834|NCT04352062|Drug|Levofloxacin 500mg|Levofloxacin 2 x 500mg
15811835|NCT04352049|Procedure|Preoxygenation|
15811836|NCT04352036|Other|no interventional study|no interventional study
15811837|NCT04352023|Procedure|Patient-controlled analgesia|Intravenous patient-controlled analgesia Patient-controlled epidural analgesia
15811838|NCT04352010|Behavioral|Res-Up!|Res-Up! is an internet-based intervention focusing on patients' strengths and positive experiences that have effects on distress, protective factors and quality of life. The intervention is based on the Personal Model of Resilience (PMR; Padesky and Mooney, 2012), which is a positive intervention that utilizes patients' strengths to overcome problems.The PMR activates resilient emotions, thoughts, metaphors, images and behaviors in four steps during five sessions about the aquisition of resilient strategies and their use in daily life. A variety of elements based on different psychotherapy approaches (Cognitive Behavioral Therapy, Emotion Focused Therapy, Positive Therapy etc.) are integrated in the program. Participants should work through one module per week. The intervention is conducted as I-CBT via the platform Minddistrict.Res-Up! is administered as a standalone or an add-on treatment to psychotherapy.
15811839|NCT04352010|Behavioral|REMOTION|REMOTION is an internet-based intervention aimed at transdiagnostically reducing symptom severity and improving emotion regulation of psychotherapy patients. The structure of REMOTION is based on the idea of an extended process model of emotion regulation as postulated by J.J. Gross (2015). The program includes the following modules: introduction, psychoeducation, identification, selection, implementation and modification. A variety of elements based on different psychotherapy approaches (Cognitive Behavioral Therapy, Emotion Focused Therapy, Dialectical Behavior Therapy etc.) are integrated in the program. Participants should work through one module per week. REMOTION is administered as a standalone or an add-on treatment to psychotherapy.
15811840|NCT04352010|Other|Wait-Control Group|In the waiting control group participants will answer questionnaires and they will gain access to either REMOTION or Res-Up! after twelve weeks.
15811841|NCT04351997|Procedure|Cord clamping|Umbilical cord clamping after delivery.
15811842|NCT04351984|Device|MitraClip|Transcatheter Mitral Valvuloplasty with MitraClip
15811843|NCT04351971|Other|Intervention Group|The patient's position is in the supine position. The therapist identifies the arches of the atlas and positions one hand at this level with the fingers extended. The other hand is located in the occipital region. Subsequently, the therapist makes a pressure with his shoulder assessing the movement and applies a pressure to the back. This technique is performed by mobilization cycles of 15 seconds and 3 seconds of rest for a total period of 5 minutes.The patient's position is in the supine position. The therapist identifies the arches of the atlas and positions one hand at this level with the fingers extended. The other hand is located in the occipital region. Subsequently, the therapist makes a pressure with his shoulder assessing the movement and applies a pressure to the back. This technique is performed by mobilization cycles of 15 seconds and 3 seconds of rest for a total period of 5 minutes.
15811844|NCT04351971|Other|Placebo group|The technique consists of placing the patient in the supine position, one hand is located in the arches of the atlas, the other hand is located in the occipital. The therapist's shoulder is located in the anterior region. This position is maintained for 5 minutes without exerting pressure.
15811845|NCT04351958|Behavioral|"Experimental: Augmented Reality (No Time Wasted)"|"No Time Wasted will be an innovative, immersive intervention using novel technology that will captivate the target audience with narrative and gaming elements to scaffold the educational message."
15811846|NCT04351945|Procedure|Blood test|Hormone levels will be measured just before transplantation, and three day after the transplantation. In case of the donors hormone levels will be defined during the explantation.
15811847|NCT04351932|Biological|bone marrow mesenchymal stem cells|intrarticular bone marrow mesenchymal stem cells injection
15811848|NCT04351932|Biological|Adipose Mesenchymal stem cells|intrarticular adipose mesenchymal stem cells injection
15811849|NCT04351932|Biological|bone marrow & adipose mesenchymal stem cells injection|intrarticular bone marrow and adipose stem cells injection.
15811850|NCT04351919|Drug|Hydroxychloroquine|400mg per day during 10 days
15811851|NCT04351919|Drug|Azithromycin|500 mg per day during 5 days
15811852|NCT04351906|Device|ECCO2R|ECCO2R integrated into the multiFiltrate device
15811853|NCT04351880|Other|Medically Tailored Meals|Compare 2 and 4 weeks of meal delivery
15811854|NCT04351867|Drug|docetaxel plus oxaliplatin and capecitabine|docetaxel 50mg/㎡ ivgtt. d1+oxaliplatin 100mg/㎡ ivgtt. d1+capecitabine 1000mg/㎡ bid p.o. d1-d14 q21d
15811855|NCT04351867|Drug|oxaliplatin plus capecitabine|oxaliplatin 130mg/㎡ ivgtt. d1+capecitabine 1000mg/㎡ bid p.o. d1-d14 q21d
15811856|NCT04351854|Other|Retrospective data collection|Retrospective data collection to identify predicting factors in the clinical picture of COVID-19 patients presenting to the ED.
15811857|NCT04351841|Other|arabinogalactan|A beverage will be prepared by thoroughly mixing the 15 g of arabinogalactan with water and Crystal Light flavoring
15811858|NCT04351841|Other|maltodextrin|A beverage will be prepared by thoroughly mixing the 15 g of maltodextrin with water and Crystal Light flavoring
15811859|NCT04351828|Procedure|Blood draw once a time|Investigation of intestinal permeability by measuring serum zonulin levels in blood sample
15811860|NCT04351815|Behavioral|Short term prehabilitation (2 weeks)|"Initial assessment visit with a dietitian, a psychologist, a physiotherapist, a doctor (physical medicine) and a geriatrician (for patients over 75 years old)
~Patient will be asked to follow a 2 weeks prehabilitation program
~2 months post-surgery assessment visit with a dietitian, a psychologist, a physiotherapist, a doctor (physical medicine)
~6 months post-surgery assessment visit with a dietitian, a psychologist, a physiotherapist, a doctor (physical medicine)"
15811903|NCT04351555|Drug|Cisplatin|Cisplatin (75mg/m2) to be administered with pemetrexed on Day 1 of every 3-week cycle for 3 cycles.
15811904|NCT04351555|Drug|Carboplatin|Carboplatin (AUC5) to be administered with pemetrexed on Day 1 of every 3-week cycle for 3 cycles
15811905|NCT04351555|Drug|Placebo|Oral
15811861|NCT04351815|Other|No specific intervention|"Standard care: Initial assessment visit with a dietitian, a psychologist, a physiotherapist, a doctor (physical medicine) and a geriatrician (for patients over 75 years old)
~Patients will be asked to maintain regular physical activity without support
~2 months post-surgery assessment visit with a dietitian, a psychologist, a physiotherapist, a doctor (physical medicine)
~6 months post-surgery assessment visit with a dietitian, a psychologist, a physiotherapist, a doctor (physical medicine)"
15811862|NCT04351802|Diagnostic Test|Lung ultrasound|Focused lung ultrasound examination
15811863|NCT04351789|Other|Psychoeducational intervention|"The written and verbal information provided at discharge to patients in the intervention arm will consist of:
~An explanation of the normal recovery period after hospitalization due to COVID-19. What can the patient expect physically, psychologically and emotionally, and what coping mechanism might be appropriate Social support in the recovery period and how this can be used constructively. In case of worsening of symptoms - physically or psychologically, where can the patient get help after discharge from hospital.
~These points are based on crisis psychology, enhancing the patients empowerment and self-management after discharge from hospital."
15811864|NCT04351776|Other|VR-Biofeedback|Participants will be instructed to use the Mindful Aurora application
15811865|NCT04351776|Other|VR-Distraction|Participants will be instructed to use one of three applications
15811866|NCT04351776|Other|360 Video|Participants will be instructed which video to view
15811867|NCT04351763|Drug|Amiodarone|Ion channel blocker
15811868|NCT04351763|Drug|Verapamil|Ion channel blocker
15811871|NCT04351737|Drug|Intracanalicular Dexamethasone, (0.4 mg) Insert|To determine post-surgical resolution of pain and inflammation outcomes with DEXTENZA compared to topical steroid treatment in patients who undergo bilateral pterygium surgery.
15811872|NCT04351737|Drug|Prednisolone Acetate|To reduce post-surgical pain and inflammation in patients who undergo bilateral pterygium surgery.
15811873|NCT04351724|Drug|Chloroquine or Hydroxychloroquine|Hydroxychloroquine 200mg 2-0-2 on day 1 followed by 200mg 1-0-1, or Chloroquine 250mg 2-0-2, as available
15811874|NCT04351724|Drug|Lopinavir/Ritonavir|Lopinavir/Ritonavir 200mg/50mg 2-0-2
15811875|NCT04351724|Other|Best standard of care|best standard of care
15811876|NCT04351724|Drug|Rivaroxaban|2.5mg 2-0-2 or 10mg 1/2-0-1/2, as applicable
15811877|NCT04351724|Drug|Thromboprophylaxis|as local standard, most likely to be low molecular weight heparin
15811878|NCT04351724|Drug|Candesartan|starting dose 4mg once daily, titrated to normotension
15811879|NCT04351724|Drug|non-RAS blocking antihypertensives|This excludes angiotensin converting enzyme inhibitors (ACEi) and angiotensin receptor blockers (AT-blockers, sartans) and includes alpha-receptor antagonists, calcium antagonists, amongst others
15811880|NCT04351724|Drug|Remdesivir|200mg on day 1, thereafter 100mg for a total of 5-10 treatment days, according to local standards
15811881|NCT04351724|Drug|Asunercept 400mg|asunercept 400mg once per week, up to 4 doses in total
15811882|NCT04351724|Drug|Asunercept 100mg|asunercept 100mg once per week, up to 4 doses in total
15811883|NCT04351724|Drug|Asunercept 25mg|asunercept 25mg once per week, up to 4 doses in total
15811884|NCT04351724|Drug|Pentaglobin|7ml/kg/day for 12h for 5 days
15811885|NCT04351711|Other|Immunological profiling|The immune activation phenotype will be assessed using a standardized panel of soluble and membrane immune activation markers
15811886|NCT04351711|Other|Immunological profiling|The immune activation phenotype will be assessed using a standardized panel of soluble and membrane immune activation markers
15811887|NCT04351698|Drug|Montelukast|Montelukast is used to treat and prevent asthma. It will decrease the symptoms and the number of acute asthma attacks. However this medicine should not be used to relieve an asthma attack that has already started.
15811888|NCT04351698|Other|Oral Placebo|Inert chewable tablet with no therapeutic value
15811891|NCT04351672|Behavioral|Early Time-Restricted Feeding|Eat between 8 am and 4 pm for two weeks
15811892|NCT04351672|Behavioral|Late Time-Restricted Feeding|Eat between 1 pm and 9 pm for two weeks
15811893|NCT04351659|Other|Blood donation from convalescent donor|Donation of 1 unit of blood or leukapheresis
15811894|NCT04351633|Other|questionnaire assesment|questionnaire assesment
15811895|NCT04351620|Drug|Hydroxychloroquine|Tolerability study of HCQ 1200 mg administered daily in divided doses for a duration of 5-10 days
15811896|NCT04351607|Dietary Supplement|Oleovital® Eisen Forte|60 mg daily oral Supplementation for 3 to 6 weeks
15811897|NCT04351594|Drug|Biofreeze 4 % Topical Gel|Biofreeze gel with active manufactured ingredient (Menthol 4%)
15811898|NCT04351594|Other|Biofreeze placebo gel|Biofreeze gel with no active manufactured to have the same look, feel and odour as Biofreeze topical gel.
15811899|NCT04351581|Other|Discontinuation of ACEi/ARB|Discontinuation of ACEi/ARB
15811900|NCT04351581|Other|Continuation of ACEi/ARB|Continuation of ACEi/ARB
15811901|NCT04351568|Other|quesionnair|questionnair about Emerging Legal and Ehical Disputes Over Patient Confidentiality
15811906|NCT04351555|Drug|Pemetrexed|Pemetrexed (500 mg/m2) to be administered with cisplatin or carboplatin on Day 1 of every 3-week cycle for 3 cycles
15811907|NCT04351542|Dietary Supplement|Ayurveda|Based on individual constitution (ayurveda based assessment) and symptoms an individual has, ayurveda herbal supplement and self managed practices were advised along with usual care recommendation.
15811908|NCT04351542|Other|Usual Care|Usual care recommended by National Health Services, self isolation, plenty fluid, rest and Paracetamol. During the Covid 19 outbreak, additional recommendation were followed given by health services.
15811909|NCT04351516|Drug|Hydroxychloroquine|dose of 600mg on the first day followed with 400mg/day divided in 2x200mg for 6 more days
15811910|NCT04351516|Other|Placebo|Placebo: Film Coated Tablette
15811911|NCT04351503|Other|Study A|Study A: collection of data of clinical outcomes and features of SARS-CoV-2 infection. Demographical, clinical, microbiological, laboratory, epidemiological and hospital-associated data will be analyzed. For this study part, only patients with a visit at the University Hospital Basel will be included in order to access patient charts.
15811912|NCT04351503|Other|Study B|Study B: collection of epidemiological surveillance data to describe the epidemiology of the SARS-CoV-2 outbreak. The epidemic transmission of Influenza viruses in the City of Basel serves as an important reference to identify similarities and differences to the pandemic SARS-CoV-2 situation. In addition data collected during the Influenza projects - in particular data on statistical blocks of the city, e.g. population density, income and living space will be re-used. Already collected and stored samples such as serum and respiratory material (leftover material) will be (re-) used.
15811913|NCT04351503|Other|Study C|Study C: data collection for viral evolution. Respiratory materials and matching blood and tissue materials will be used to perform whole genome sequencing to study pathogen evolution between hosts as well as in-host evolution. No additional material will be collected.
15811914|NCT04351503|Other|Study D|"Study D: collection of safety and efficacy data of different treatment modalities. Currently the following treatments are considered as part of the treatment:
~Lopinavir/Ritonavir
~Hydroxychloroquine
~Tocilizumab
~Eculizumab
~Ruxolitinib
~Remdesivir
~Treatment with convalescent plasma blood count, blood chemistry and pulmonary function test (collected on a routine basis during hospitalization and in the outpatient setting)."
15811915|NCT04351490|Dietary Supplement|Zinc gluconate|Zinc gluconate capsule 15 mg x 2 per day during 2 months
15811916|NCT04351490|Dietary Supplement|25-OH cholecalciferol|25-OH cholecalciferol drinkable solution 10 drops (2000 IU) per day during 2 months
15811917|NCT04351477|Device|Massage chair|Mechanical massage chair
15811918|NCT04351464|Other|physical therapy and reflexology|
15811919|NCT04351451|Procedure|thyroidectomy|total thyroidectomy
15811920|NCT04351438|Device|Active Comparator: centrifuge TPE with citrate|Patients who received citrate-based anticoagulation with centrifuge TPE
15811921|NCT04351438|Device|Active Comparator: Filter TPE with heparin|Patients who received heparin-based anticoagulation with filter TPE
15811922|NCT04351438|Drug|Active comparator: Filter TPE with citrate|Patients who received citrate-based anticoagulation with filter TPE
15811923|NCT04351425|Device|Weaning to crib|We weaned the infants into two groups. Group A, 1.6 kg
15811924|NCT04351425|Device|Weaning from incubator|We weaned the infants into two groups. group B, 1.4 kg
15811925|NCT04351412|Other|Gluma|Gluma is desensitizing agent by (Heraeus Kulzer, Armonk, NY, USA) claimed to treat dentine hypersensitivity in exposed cervical teeth surfaces and was applied to participants using a mini brush applicator tip onto the exposed hypersensitive tooth surface requiring treatment and was allowed to dry for 60 seconds. Then Dentine hypersensitivity (DH) was assessed for tactile, cold, and air blast stimuli immediately after completion of treatment. Subjects were also recalled for re-evaluation at 2 weeks and at 1 month after desensitizing treatment.
15811926|NCT04351412|Other|fluoride varnish|fluoride varnish is usually applied to patients to prevent caries development but was claimed in some cases to also relief dentine hypersensitivity and was applied as a thin layer to the surface of the tooth using an applicator. The varnish set rapidly, and thereafter moisture contamination was not a concern. Patients were advised to not brush or floss their teeth for a couple of hours and to abstain from hot beverages. DH was assessed for tactile, cold, and air blast stimuli immediately after completion of treatment. Subjects were also recalled for re-evaluation at 2 weeks and at 1 month after desensitizing treatment.
15811927|NCT04351412|Other|Tetric N-Bond self-etch adhesive|Tetric N-Bond self-etch adhesive is one step dental adhesive and is also claimed to relief dentine hypersensitivity due to blockage of dentinal tubules. It was applied according to the manufacturer's instructions, in a thick layer, for at least 30 seconds, using a light brushing motion. Then, it was dried with a steady stream of air for 3 seconds and light-cured for 10 seconds. DH was assessed for tactile, cold, and air blast stimuli immediately after completion of treatment. Subjects were also recalled for re-evaluation at 2 weeks and at 1 month after desensitizing treatment.
15811928|NCT04351399|Other|questionnaire assesment|The questionnaire will ask questions around their socio-demographic characteristics,quality of life, painful, using analgesic , since they are in quarantine
15811929|NCT04351386|Device|AF Detection|Recording PPG and single-lead ECG signals with the Withings HWA09 and ECG signal for the reference 12-lead ECG
15811932|NCT04351347|Drug|Ivermectin|ivermectin
15811933|NCT04351334|Drug|Alectinib|Observational treatment based on physician choice
15811934|NCT04351321|Procedure|Totally Laparoscopic Total Gastrectomy|Totally laparoscopic total gastrectomy will be performed in patients with gastric or esophagogastric junction adenocarcinoma of preoperative clinical stage I (T1N0M0, T1N1M0, T2N0M0) with D1+/D2 lymph node dissection.
15811935|NCT04351321|Procedure|Laparoscopy-Assisted Total Gastrectomy|Laparoscopy-Assisted Total Gastrectomy will be performed in patients with gastric or esophagogastric junction adenocarcinoma of preoperative clinical stage I (T1N0M0, T1N1M0, T2N0M0) with D1+/D2 lymph node dissection.
15811936|NCT04351308|Drug|MAPI chemotherapy|"AP = Doxorubicin (Adriamycin) 37.5 mg/m2/day * 2day (total/cycle 75 mg/m²)
~+ Cisplatin 120 mg/m2/course (total/cycle 120 mg/m²) ; M = Methotrexate 12000 mg/m2 (total/cycle 12000 mg/m²) with leucovorin rescue; I = Ifosfamide 2400 mg/m2/day *5day (total/cycle 12000 mg/m²)"
15811941|NCT04351282|Radiation|SBRT|SBRT for oligometastatic lesions will be assigned to those who got PR,SD after systemic treatment.
15811942|NCT04351269|Device|CanGaroo Envelope|CanGaroo envelope with CIED implantation
15811943|NCT04351269|Device|Tyrx Envelope|Tyrx envelope with CIED implantation
15811944|NCT04351256|Drug|Durvalumab Injection [Imfinzi]|Durvalumab fixed dose of 1,500 mg
15811945|NCT04351256|Radiation|Thoracic Radiotherapy (TRT) conventionally|Conventionally fractionated TRT consisting of 30 x 2 Gy (60 Gy) within 6 weeks
15811946|NCT04351256|Radiation|Thoracic Radiotherapy (TRT) hypofractionated|Hypofractionated TRT consisting of 20 x 2,75 Gy (55 Gy) within 4 weeks
15811947|NCT04351243|Drug|Gimsilumab|Gimsilumab is a fully human monoclonal antibody (mAb).
15811948|NCT04351243|Drug|Placebo|Normal saline
15811949|NCT04351230|Drug|Abemaciclib|Given IV
15811950|NCT04351230|Biological|Trastuzumab Emtansine|Given PO
15811951|NCT04351217|Behavioral|Music|Raga Ahir Bhairav and Bhairavi were used, played primarily on flute, without lyrics.
15811952|NCT04351217|Behavioral|Progressive Muscle Relaxation|The instructions were recorded in both English and the local language, Kannada
15811953|NCT04351204|Radiation|radiotherapy|multiple new techniques and software for MR-guided adaptive radiation therapy.
15811954|NCT04351191|Drug|Hydroxychloroquine Sulfate Regular dose|Hydroxychloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2
15811955|NCT04351191|Drug|Hydroxychloroquine Sulfate Loading Dose|Hydroxychloroquine administered as a loading dose only
15811956|NCT04351191|Drug|Chloroquine|Chloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2
15811957|NCT04351191|Drug|Placebo|Standard of Care plus placebo
15811958|NCT04351178|Behavioral|Mobile phone supported and team based rehabilitation|Participants in the intervention group will receive an 8-week mobile phone supported and team based rehabilitation intervention (F@ce 2.0).The participants will be introduced to a problem-solving strategy intended to facilitate the learning and problem-solving process to be used during the intervention. The strategy will provide a structure for healthcare professionals delivering the intervention. Three goals in daily activities will be formulated that the person wants and needs to do within the home environment. Each activity will be practiced together with the healthcare professionals and significant others. The significant others will be informed about the participant's goals and the planned strategies for reaching the goals. The participants will practice the activities in their home environment supported by mobile phone calls and text messages. In addition they will be given information about stroke.
15811959|NCT04351178|Behavioral|Rehabilitation as usual|Control group participants will receive rehabilitation as usual and in addition information about stroke.
15811960|NCT04351165|Drug|IMP4297|IMP4297 10mg/capsule; IMP4297 20mg/capsule;
15811961|NCT04351152|Biological|Lenzilumab|Administered as an intravenous (IV) infusion
15811962|NCT04351152|Drug|Standard of Care|Standard of care therapy can include remdesivir and/or dexamethasone per institutional treatment guidelines or written policies
15811963|NCT04351139|Other|modification of the planned therapeutic management|to evaluate the changes in therapeutic management, during the COVID-19 pandemic, of patients suffering from gynecological cancers
15811964|NCT04351126|Drug|Fludrocortisone 0.1 Milligrams (mg)|0.2-0.6 mg/day of fludrocortisone is prescribed
15811965|NCT04351126|Drug|Bromocriptine|2.5 mg prescribed Vaginally twice daily
15811966|NCT04351113|Dietary Supplement|MITO-AO|Participants will receive 160 mg with breakfast on day 1 of bed rest and 40 mg with breakfast on days 2-5.
15811967|NCT04351113|Dietary Supplement|PB-125|Participants will receive 100 mg on days 1-5 of bed rest.
15811968|NCT04351113|Other|Placebo|Participants will receive Placebo on days 1-5 of bed rest.
15811969|NCT04351113|Other|Passive Leg Movement (PLM)|Participants will be tested for passive leg movement on baseline day 1, bed rest day 1, and post bed rest.
15811970|NCT04351113|Other|Plantar flexion|Participants will undergo plantar flexion on baseline day 2, pre bed rest, and post bed rest.
15811971|NCT04351113|Other|Isometric knee extensor test|Participants will undergo isometric knee extension on baseline day 2, pre bed rest, and post bed rest.
15811972|NCT04351113|Other|Bed rest|Participants will undergo 5 days bed rest after 5 day baseline assessments
15811973|NCT04351100|Drug|Diacerein|Diacerein prescribing by orthopedist. Dry eye sign and symptom was asses before start diacerein and after 2 months.
15811974|NCT04351087|Device|Platelet Rich Plasma|"Platelet rich plasma: 157cc of whole blood will be collected, processed, and injected into the knee joint under sterile technique using ultrasound-guidance.
~Microfragmented adipose tissue: Adipose will be aspirated from the subcutaneous tissue of the buttock or abdomen, processed, and injected into the knee joint under sterile technique using ultrasound-guidance."
15811975|NCT04351074|Procedure|LIFT|ligation of the intersphincteric fistula track
15811976|NCT04351074|Procedure|fistulectomy|excision of the fistulous track with its internal and external orifices
15811977|NCT04351061|Drug|Acetazolamide|Acetazolamide 500 mg by mouth twice per day for 7 consecutive days.
15811978|NCT04351048|Procedure|Stepwise Excavation|"stepwise excavation includes selective caries removal to soft dentine on pulpal wall in the first stage of the excavation and
~after six months, the second stage of intervention includes re-entring the cavities and wall selective removal to firm dentine on pulpal wall."
15811979|NCT04351048|Procedure|One Step Excavation|*one step excavations is completed in the first stage via performing selective removal to soft dentine on pulpal wall of the cavities.
15811980|NCT04351035|Procedure|Tumour resection|It is mandatory that patients recieve surgical treatment for pathological diagnosis of CNS tumours in enrolled patients. Surgical resection of tumours could be regarded as total / subtotal / partial resection and biopsy.
15811981|NCT04351022|Biological|CART-38|Split intravenous infusion of CART-38 cells [dose escalating infusion of (5-20)x10^6 CART-38 cells/kg].
15811982|NCT04351009|Procedure|sentinel lymph node mapping|Through on-table colonoscopy indocyanine green solution will be injected in the submucosa at 2-4 points around the tumor. Lymphatic flow from the tumor will be mapped in real time with near-infrared fluorescence imaging scope and sentinel lymph nodes will be identified.
15812011|NCT04350749|Biological|PRF is added in the test group.|The PRF membrane can be considered as a biological membrane
15811983|NCT04350996|Other|Wearable alcohol sensor|BACtrack Skyn, is a novel transdermal blood alcohol sensor developed by BACtrack, a company established for police-grade breathalyzers, and winner of the Wearable Alcohol Biosensor Challenge sponsored National Institute on Alcohol Abuse and Alcoholism.
15811984|NCT04350983|Behavioral|Increased physical activity|PAP and enhanced individual support by physiotherapist to increase physical activity
15811985|NCT04350970|Other|High flow nasal therapy|All patients underwent two cardiopulmonary exercises with constant-load at 90% of the peak workload. The high flow nasal therapy was used during all exercise test.
15811986|NCT04350970|Other|Non-invasive ventilation|All patients underwent two cardiopulmonary exercises with constant-load at 90% of the peak workload. The NIV was used during all exercise test.
15811987|NCT04350970|Other|Control|All patients underwent two cardiopulmonary exercises with constant-load at 90% of the peak workload. The control test was performed with no additional therapy.
15811988|NCT04350957|Diagnostic Test|Low-dose Imaging|"We are comparing MRI image quality for diagnostic purposes. We hope to learn whether using a lesser dose (25%) of the FDA approved contrast agent, Gadavist®, is just as effective as a standard or full dose (100%) of the same contrast in a breast MRI.
~This research is being done because breast MRI's have repeatedly been shown to represent the most reliable imaging method for breast cancer screening and diagnosis, regardless of personal risk for breast cancer and radiographic breast density. However, there are growing concerns about getting frequent breast MRI examinations due to the deposition of gadolinium, a metal ion that is found in all breast MRI contrast agents. The FDA states that this deposition and retention is not known to have any long term side effects on patient. However, the researchers at the University of Chicago Medicine would like to further investigate this using a lesser dose of contrast agent than the recommended dose for breast MRI examinations."
15811989|NCT04350931|Biological|intradermal injection of BCG Vaccine|0.10 mL intradermal injection of BCG Vaccine over the distal insertion of the deltoid muscle onto the humerus (approximately one third down the left upper arm) slowly over 10 seconds
15811990|NCT04350931|Other|placebo|placebo 0.10 mL intradermal normal saline (0.9% NaCl) over the distal insertion of the deltoid muscle onto the humerus
15811991|NCT04350918|Device|Muscle Enery Techniques|Group of patients that underwent muscle energy technique as a mean of treatment for the complaint
15811992|NCT04350918|Device|Static Stretching|Set of patients that had static stretching technique for the treatment for the complaint
15811993|NCT04350905|Other|Mosquito Feeding|Mosquito feedings will be conducted with Aedes aegypti colonies raised at the CNM (National Malaria Center) Malaria and Vector Research Laboratory (MVRL), an established state of the art insectaries for mosquitoes was built in 2014 to ACL2 (arthropodcontainment level 2)-level specifications.
15811994|NCT04350892|Procedure|Roux-en-Y Gastric Bypass (RYGB)|"This surgery is often called gastric bypass. It is a weight-loss surgery that involves creating a small stomach pouch and bypassing part of the small intestine.
~If you decide with your doctor to have gastric bypass, you can be enrolled on this arm of the study. A surgery date should be pending before the investigators screen you for the study. The study does not cover the cost of the Roux-en-Y gastric bypass."
15811995|NCT04350892|Procedure|Sleeve Gastrectomy (SG)|"Sleeve gastrectomy, is a weight-loss surgery that involves removing about 80% of the stomach.
~If you decide with your doctor to have sleeve gastrectomy, you can be enrolled on this arm of the study. A surgery date should be pending before the investigators screen you for the study. The study does not cover the cost of the sleeve gastrectomy."
15811996|NCT04350892|Behavioral|Very Low Calorie Diet (VLCD)|Weight loss with calorie restricted liquid diet. Participants will be placed on a 800 kcal/day diet for meal replacement (Optifast) provided by the investigator for 12 weeks. Participants will be monitored weekly by the study dietician and medical staff.
15811997|NCT04350879|Other|Data record|Data record
15811998|NCT04350866|Other|Expert Recommendations for Implementing Change (ERIC) bundle of strategies|"Develop a formal implementation blueprint/checklist
~Conduct educational meetings; Develop & distribute educational materials
~Organize implementation meetings
~Audit and provide feedback
~Facilitation
~Increase demand with marketing to patients
~Promote adaptability
~Involve patients and family; Use their feedback; Prepare them to be active participants"
15811999|NCT04350853|Procedure|Surgical extrusion|Surgically coronal reposition of the tooth
15812000|NCT04350840|Behavioral|feedback|feedback of optical diagnosis performance per 3 month
15812001|NCT04350827|Device|Platelet Rich Plasma|Platelet rich plasma injection into patellar tendon
15812002|NCT04350827|Device|Platelet Rich Plasma plus IGF|Platelet rich plasma plus IGF injection into patellar tendon
15812003|NCT04350814|Behavioral|Self-Compassion Step by Step|This is a 6-lesson self-guided audio program by Dr. Kristen Neff (2013)
15812004|NCT04350814|Behavioral|Self-Reflection Active Control|Participants randomized to this active control condition will be asked to complete study measures at the same intervals as those assigned to the intervention condition. In addition to completing study questionnaires, participants in this arm will also be invited to reflect on their weekly reported symptoms, whether they experienced changed, what they believe these changes are attributed to, etc.
15812005|NCT04350801|Diagnostic Test|home-based cognitive monitoring|a newly developed home-based cognitive monitoring (about 3-5 minutes per test; total score ranges from 0~30; higher score indicates better cognition)
15812006|NCT04350788|Other|Survivorship Care Plan|Participants visit the NCI prostate cancer website in addition to their standardized post-treatment survivorship care
15812007|NCT04350788|Other|Enhanced Survivorship Care Plan|In addition to their standardized post-treatment survivorship care, participants visit the prostate cancer education resources for couples (PERC) website that was based on scientific evidence and input from stakeholders including PC patients, partners, and cancer care providers. Participants learn about skills and knowledge about how to enhance their positive appraisals of symptoms and self-efficacy in symptom management through information and skills training, fostering healthy behaviors, and facilitating social support
15812008|NCT04350775|Other|RE-IADL|RE-IADL program is to conduct trainings related to instrumental activities of daily living. For example,using communication appliance, moving in community, financial management, health care, housework, prepare meals and clear ,and shopping.
15812009|NCT04350775|Other|General community rehabilitation|General community rehabilitation contains the activities in psychiatric rehabilitation center.
15812010|NCT04350762|Dietary Supplement|Protein shake + Fish Oil|2 shakes of protein as well as 1 fish oil daily.
15812014|NCT04350723|Procedure|Awake Proning|The duration of proning will be a total of 8-10 hours with 1-2 hours break in supine position.
15812015|NCT04350710|Other|PEEP trial|Measurement of Recruitment-to-Inflation Ratio
15812016|NCT04350697|Procedure|Aortic Surgery|Surgery for aortic and/or aortic valve diseases
15812017|NCT04350684|Drug|Umifenovir|This will be drug only used in the intervention arm of our study, designed mainly to assess the additional efficacy and safety of Umifenovir in COVID-19 patients.
15812018|NCT04350684|Drug|Interferon-β 1a|This Drug will be used in all arms as we discovered its benefits in our previous randomized clinical trial.
15812019|NCT04350684|Drug|Lopinavir / Ritonavir|This Drug will be used in all arms as mandated by our governmental guidelines.
15812020|NCT04350684|Drug|Single Dose of Hydroxychloroquine|This Drug will be used in all arms as mandated by our governmental guidelines.
15812021|NCT04350684|Drug|Standards of Care|This Drug will be used in all arms as mandated by our governmental guidelines.
15812022|NCT04350671|Drug|Interferon Beta-1A|This will be drug only used in the intervention arm of our study, designed mainly to assess the additional efficacy and safety of Interferon-β 1a in COVID-19 patients.
15812023|NCT04350671|Drug|Lopinavir / Ritonavir|This Drug will be used in all arms as mandated by our governmental guidelines.
15812024|NCT04350671|Drug|Single Dose of Hydroxychloroquine|This Drug will be used in all arms as mandated by our governmental guidelines.
15812025|NCT04350658|Procedure|Transcatheter aortic valve implantation required for symptomatic aortic stenosis|The procedure is performed via transfemoral or transcarotid access; Patients were confirmed to be eligible for TAVR by a multidisciplinary heart team including at least an interventional cardiologist, a cardiothoracic surgeon and an anesthetist. All TAVR implantation procedures were performed with the Edwards SAPIEN 3 THV or the MEDTRONIC CoreValve EVOLUT . For all patients, both vascular access and aortic valve were evaluated before the procedure by multislice computerized tomographic angiography (MSCT) of the entire aorta using vascular windows settings. The prosthesis and the vascular access were left to the discretion of the operating team. Transfemoral access was the first choice when possible. All TAVR procedures were performed in the same hybrid room (in Montpellier University Hospital), Most TAVR were performed under sedation or general anesthesia using mild low profile 14-16 French delivery systems and using percutaneous or surgical vascular access.
15812026|NCT04350645|Drug|Tranexamic acid injection|1g slow bolus of tranexamic acid over 2 minutes
15812027|NCT04350645|Drug|Normal Saline 0.9%|10mls normal saline 0.9% over 2 minutes
15812028|NCT04350632|Diagnostic Test|Shear wave elastography assessment of the external anal sphincter|"Assessment of the external anal sphincter viscoelastic properties using shear wave elastography technology
~Women in lithotomy position with an empty bladder
~The linear probe is applied on transversal plane on the perineal with a transperineal approach
~The external anal sphincter will be identified in 2D ultrasound using a SL 18-5 linear probe
~Viscoelastic properties of the muscle will be assessed by measuring the shear modulus at rest, Valsalva maneuver and contraction
~Exactly the same investigations will be performed for the two visits planned in the protocol. In the first visit, it will be one single observer and for the second it will be 2 observers.
~Data about the mode of delivery and the occurrence of OASI will be collected into women's medical fil"
15812029|NCT04350619|Other|Genetic screening. No therapeutic intervention|Genetic screening using NGS technique. No therapeutic intervention
15812030|NCT04350606|Biological|PF-06462700|PF-06462700 is classified as an immunosuppressant/ immunosuppressive agent. It is the purified, concentrated, and sterile gamma globulin, primarily monomeric immunoglobulin G (IgG), from hyperimmune serum of horses that are immunized with human thymus lymphocytes.
15812031|NCT04350593|Drug|Dapagliflozin 10 MG|Active Comparator: Dapagliflozin 10mg
15812032|NCT04350593|Drug|Placebo|Placebo Comparator
15812033|NCT04350580|Drug|Human immunoglobulin|Human immunoglobulin 2g/kg over 4 days (0.5g/kg/d)
15812034|NCT04350580|Drug|Placebo|Sodium chloride 0.9% in the same volume and over the same time as the immunoglobulin
15812035|NCT04350567|Other|Sleep Deprivation|On the first night, the participant sleeps normally as we assess their melatonin through blood work. On the second night, the participant has 3 PET/MRI scans. On the third night, the participant undergoes sleep deprivation. On the fourth night, the participant sleeps normally and we assess their melatonin again through blood work. Depression scores are taken before and after the intervention.
15812036|NCT04350554|Other|Pregnancy|To measure and characterize pregnancies and describe the clinical course during pregnancy
15812037|NCT04350554|Other|Pregnancy|To evaluate attitudes towards pregnancy (ie. planned pregnancy) and social support among women who become pregnant during the year 2020
15812038|NCT04350541|Other|High-intensity interval training|Exercise with high-intensity intervals followed by active rest
15812039|NCT04350541|Other|Continuous aerobic training|Interval Moderate-intensity aerobic training without intervals
15812040|NCT04350528|Drug|Chlorpromazine or Pentobarbital|Sedation
15812041|NCT04350515|Other|Cyberball: Other Exclusion|A cyberball paradigm, whereas 2 avatars and the subject are playing a virtual ball tossing game. In this condition, one of the avatars is excluded.
15812042|NCT04350515|Other|Cyberball: Player Exclusion|A cyberball paradigm, whereas 2 avatars and the subject are playing a virtual ball tossing game. In this condition, the subject is excluded by the avatars.
15812043|NCT04350515|Other|Mindfulness: Emotion Regulation Task|In this task, subjects listen to an audio file containing a scripted emotion regulation exercise. This exercise is based by the authors Nissen & Sturm (2018). It takes around 14 minutes to complete the whole task.
15812044|NCT04350515|Other|Mindfulness: Word Recognition Task|"In this task, subjects listen to an audio file containing a scripted word recognition exercise. It contains both contrary words recognition (e.g. The opposite of loud is ...) and completion of german sayings (e.g. That's where the dog is...). It takes around 14 minutes to complete the whole task."
15812045|NCT04350502|Procedure|chest tube drainage|Patients with a complicated pleural infection will be managed according to the French guideline with a chest tube drainage associated to a treatment with amoxicillin (2g*3 by day) and clavulanic acid (200mg*3 by day).
15812069|NCT04350320|Drug|Standard therapy for COVID-19 according to the stablished hospital protocols.|standard therapy for COVID-19 according to the stablished hospital protocols.
15812070|NCT04350307|Device|22-gauge needle|22-gauge Quincke needle used for epidural injection
15812046|NCT04350502|Biological|antibiotic concentration in pleural fluid|Patients with a complicated pleural infection will be managed according to the French guideline with a chest tube drainage associated to a treatment with amoxicillin (2g*3 by day) and clavulanic acid (200mg*3 by day). Repeated samples of pleural fluid and serum will be taken to evaluate antibiotics' concentrations at H0; H½; H1; H2; H3; H4; H8 and H24
15812047|NCT04350502|Drug|Amoxicillin + clavulanic acid|Patients with a complicated pleural infection will be managed according to the French guideline with a chest tube drainage associated to a treatment with amoxicillin (2g*3 by day) and clavulanic acid (200mg*3 by day). Repeated samples of pleural fluid and serum will be taken to evaluate antibiotics' concentrations at H0; H½; H1; H2; H3; H4; H8 and H24
15812048|NCT04350489|Other|Non-surgical periodontal treatment|Conventional non-surgical periodontal treatment were performed
15812049|NCT04350476|Diagnostic Test|VitalConnect Vital Sign Patch|"This patch provides continuous real-time monitoring of cardiac telemetry, heart rate, respiratory rate and oxygen saturation. Duration of monitoring is typically up to 7 days.
~This patch is applied to the upper left side of the chest wall, attached with a hypoallergenic adhesive material. (This device is FDA approved for this indication)."
15812050|NCT04350463|Drug|CC-90011|CC-90011
15812051|NCT04350463|Drug|Nivolumab|Nivolumab
15812052|NCT04350450|Drug|Hydroxychloroquine|400 mg tablet
15812053|NCT04350437|Drug|induction of labor|Giving drugs to facilitate uterine contractions and fasten the process of delivery
15812054|NCT04350411|Device|Conventional diathermy|Abdominal free flap raise performed with conventional diathermy. Settings: cutting 40 Watt, coagulation 40 Watt.
15812055|NCT04350411|Device|PEAK PlasmaBlade™|Abdominal free flap raise performed with PEAK PlasmaBlade™ Settings: cutting 7 (35 Watt), coagulation 7 (35 Watt)
15812056|NCT04350398|Other|Hippotherapy|The horse is an excellent collaborator in situations of physical and mental disability, whether temporary or consolidated. It provides support to humans towards an impairment (anatomical or physiological), a disability, or a restriction of participation as defined by the WHO in 2001. Hippotherapy has a direct action on the sensorimotor capacities of the individual but also on their cognitive capacities, such as attention, memory, psychomotricity, emotions, perceptions, the sequencing of complex movements, or the experience of oneself and the functions of time. Overall, the strong demand from the sensitive, sensory and motor spheres promotes and interacts with the mechanisms linked to the execution of tasks in the cognitive domain (memory, attention, executive functions, speed of information processing, etc.) through the interactions of several neural networks.
15812057|NCT04350398|Other|Conventional therapy|Personalized care pathway after/during the cancer treatment takes into consideration all aspects of the disease, allowing to coordinate the intervention of the professionals that the patient might need in order to better preserve her quality of life while answering questions about cancer, prevention, treatments, or life after illness. The MIS mobilizes a chain of skills and support by providing patients: radiologists, pathologists, surgeons, oncologists, and radiation therapists, nuclear doctors, physiotherapists, cardiologists, psychologists, psychiatrists, nurses, social workers, nutritionists, dieticians, onco-geneticists, osteopaths, homeopaths, acupuncturists, sexologists, addictologists, algologists, and vascular physicians.
15812058|NCT04350385|Other|Agility training|In experimental group, 30 meter sprint test will be used as intervention with complexity in different stages. Test 1 was a straight sprint and tests 2-7 involved multiple changes of direction. Tests 2-7 were designed to involve progressively greater change-of-direction complexity by increasing either the angle of directional change and/or the number of changes of direction. In experimental group, 6 weeks of intervention will be done on alternate days and assessment will be done on 1st, 3rd & 6th week.
15812059|NCT04350385|Other|Conventional|In group B, Conventional intervention was given to the players under the supervision of Physical Therapist that includes warm-up, strength training, agility training and cool down. In control group, 6 weeks of intervention will be done on alternate days and assessment will be done on 1st, 3rd & 6th week
15812060|NCT04350372|Device|MitraClip Procedure|MitraClip procedure with MitraClip NT System
15812061|NCT04350359|Device|Variable-dose TTNS Protocol 5 x week|Electrodes 2 inch by 2 inch will be placed according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. The intensity level will be set to the amperage immediately under the threshold for motor contraction. If there is no contraction seen, patients will be excluded. In addition, if the patient perceives pain, the intensity will be lowered until comfortable. Stimulation frequency of 20 Hz and pulse width of 200ms in continuous mode will be used.
15812062|NCT04350359|Device|Fixed-dose TTNS Protocol|Toe flexion will be attempted, as in the TTNS protocol. Then the stimulation will be reduced to 1 mA for 30 minutes. This will continue at 5x weekly until 1-year post-injury.
15812063|NCT04350359|Device|Variable-dose TTNS Protocol 2 x week|At the 4 month CMG, subjects initially randomized into the variable dose protocol of 2 x weekly will start doing so for the remainder of the study.
15812064|NCT04350346|Drug|Motilitone|"Ingredients and content: corydalis tuber, pharbitis seed 50% EtOH extracts 30mg
~Dosage method: Usually, adults take 1 tablet 3 times a day orally before meals.
~Pharmacological action:
~It stimulates 5-HT4 receptor as a gastrointestinal motility accelerator to increase acetylcholine secretion and contract smooth muscle.
~Stimulates stomach smooth muscle contraction by suppressing the effect of dopamine on acetylcholine secretion by inhibiting D2 receptor ③ It shows a pharmacological action that stimulates gastrointestinal movement by acting in combination with 5-HT1A / B receptor."
15812065|NCT04350346|Drug|Gasmotin|"Ingredient and content: mosapride citrate dihydrate 5.29mg (5mg as active ingredient)
~Dosage method: Usually, an adult is orally administered 1 tablet 3 times a day before meals.
~Pharmacological action: mosapride is a selective serotonin-4 (5-HT4) receptor agonist with gastrointestinal stimulating activity, contracting smooth muscle"
15812066|NCT04350333|Behavioral|CBT-I|Strategies and techniques of Cognitive behavioral therapy for insomnia adapted for pregnant women: stimulus control; sleep hygiene; sleep restriction; cognitive control etc.
15812067|NCT04350333|Behavioral|Assertive communication training|Intervention based on improving assertive communication and regulating emotions.
15812068|NCT04350320|Drug|Colchicine Tablets|standard therapy for COVID-19 according to the stablished hospital protocols.
15812071|NCT04350307|Device|25-gauge needle|25-gauge Quincke needle used for epidural injection
15812072|NCT04350281|Drug|Interferon Beta-1B|Daily subcutaneous injection of interferon β-1b 1mL (0.25mg; 8 million IU) consecutively on day 1 to day 3
15812073|NCT04350281|Drug|Hydroxychloroquine|Hydroxychloroquine 800mg on day 1, then 400mg daily for 2 days
15812074|NCT04350268|Device|Wearable sensor|Wireless sensor
15812075|NCT04350255|Device|Total hip arthroplasty|Total hip arthroplasty with a Trident II hemispherical cup
15812076|NCT04350255|Device|Total hip arthroplasty|Total hip arthroplasty with a Trident II Tritanium cup
15812077|NCT04350229|Drug|Drug omission|Drug omission. In the experimental group, dexamethasone will be omitted from the second application of paclitaxel.
15812078|NCT04350229|Other|Control group|No drug omission. In the control group, dexamethasone will not be omitted in the second application of paclitaxel.
15812079|NCT04350216|Drug|Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]|"The treatment of sarilumab 200mg will be administered every two weeks subcutaneously.
~Each patient will be followed for 6 months from the start of treatment. The last administration of Sarilumab will be 2 weeks before the end of the study."
15812080|NCT04350203|Procedure|Laparoscopic right colectomy with intracorporeal anastomosis (IA)|First, the right colon dissection was completed by laparoscopy. An isoperistaltic side-to-side ileocolonic mechanical anastomosis was then performed by using a linear cutting stapler. The enterotomy used to enter the stapler was closed with a running suture (3-0 absorbable monofilament or a 3-0 barbed suture). Finally, the specimen was extracted through a Pfannenstiel mini-laparotomy (4-5 cm).
15812081|NCT04350203|Procedure|Laparoscopic right colectomy with extracorporeal anastomosis (EA)|First, the right colon was widely mobilized. A small laparotomy was performed in the mid/upper abdomen to exteriorize the colon and to perform a side-to-side mechanical anastomosis, using a linear cutting stapler (GIA). The bowel opening was closed either with a manual suture or by a second firing of the GIA.
15812082|NCT04350190|Drug|Apatinib mesylate tablet|The dose of apatinib mesylate tablets is 250mg, oral, qd, continuous administration, 4 weeks (28 days) as an observation cycle.
15812083|NCT04350190|Drug|PD-1|The dose of PD - 1 is 200 mg/ time, intravenous injection, q2w, 4 weeks (28 days) for an observation period.
15812086|NCT04350164|Drug|Romiplostim|romiplostim once weekly subcutaneously at an initial dose of 8-9 µg/kg per week for at least 1 month to 1 year.
15812087|NCT04350151|Behavioral|no intervention|no intervention
15812090|NCT04350125|Biological|Autologous Platelet Rich Plasma|One 4-5mL platelet rich plasma injection administered to each side of the intracavernosal space on the right and left side of the corpus cavernosum at the base of the penis, every two weeks for 6 weeks.
15812091|NCT04350112|Other|Clinical assessment|Clinical assessment (history, examination) is gold standard for diagnosing constipation - gold standard will be compared with simple question about constipation, Rome IV diagnostic criteria for OIC, and common definitions of constipation for constipation / OIC
15812092|NCT04350099|Other|quetionnary|Participants will complete self-questionnaires at different times during the epidemic
15812093|NCT04350086|Drug|Treatment with Dexmedetomidine|Administration of Dexmedetomidine in continuous infusion by electric syringe pump at a dose of 0.4 µg / kg / h, with dose adjustment according to the sedation score and tolerance.
15812097|NCT04350060|Other|Retro-fitted room with technological enhancements|Reconstructing and retrofitting a currently existing memory care room at Samaritan Bethany Arbor Terrace Senior Living with integrated technologies specifically to accommodate the needs of persons with dementia to enhance sensory stimulation in sight, sound and sleep.
15812098|NCT04350047|Procedure|Radical nephrectomy with inferior vena cava thrombectomy without thoracotomy|The abdomen was accessed through a Makuuchi incision. After mobilization of the liver and assessment of the inferior vena cava infiltration (IVC), IVC was clamped below the level of the renal veins. In order to get access to the intrapericardial IVC, an incision was made through the tendon of the diaphragm and a clamp was placed first in the hepatoduodenal ligament (Pringle maneuver) and then in the endopericardial portion of the IVC, in that order. A longitudinal 3-4 cm incision was made incorporating the junction of IVC and right renal vein. After tumor removal thrombus was removed and a fine clamp was placed at the IVC just below the hepatocaval junction and immediate release of the clamping of the hepatoduodenal ligament. Total endopericardial clamp time was 4 minutes. Patients then underwent radical nephrectomy in a standard fashion with en bloc resection of the IVC thrombus.
15812099|NCT04350034|Other|Xbox training|"patients in this group received routine physical therapy protocol plus Xbox training.
~Before the intervention started, the Xbox group was given a 45 min introductory session on how to use the xbox adventure games and its tools. All sessions were led by a single experienced physiotherapist (different to the physiotherapist who performed the assessments tests) in order to provide instruction on how to perform each exercise."
15812100|NCT04350034|Other|Control group|routine physical therapy protocol (RPTP) including joint range of motion exercises (ROM), muscle stretching technique, splinting, daily walking, and ADL training.
15812101|NCT04350021|Drug|Capecitabine, Cyclophosphamide|Capecitabine 500 mg times three, Cyclophosphamide 50 mg once daily
15812206|NCT04349124|Drug|Nifedipine Extended-Release Tablets|Antihypertensive
15812207|NCT04349124|Other|No Antihypertensive Medication|Control (no intervention)
15812102|NCT04350008|Device|Renamic Neo programmer device, including software; PK-222-L ECG cable|Patients will be enrolled either for implantation including subsequent pre-hospital discharge or for a follow-up visit only. ICM patients will be included for follow-ups only. Implants will be programmed and interrogated by using the investigational devices.
15812103|NCT04349995|Device|Amplatzer PFO Occluder|Percutaneous PFO closure using Amplatzer PFO Occluder
15812104|NCT04349982|Diagnostic Test|Biomarker (TropT, Myoglobin, CK, CK-MB, LDH, D-dimer, CRP, PCT)|Factorial
15812105|NCT04349969|Drug|AK117|An intravenous (IV) infusion of AK117 as monotherapy. All subjects will receive 4 weekly infusions (Days 1, 8, 15, and 22) of AK117 in each 28-day treatment cycle until unacceptable toxicity, documentation of confirmed progressive disease (PD), or subject withdrawal
15812106|NCT04349956|Drug|UBX0101 or placebo|This is an observational study. No intervention is administered.
15812107|NCT04349943|Other|nutrition therapy|With enteral nutrition as the preferred solution, the gradual transition from slow to fast, from lean to dense, from essential to whole protein type is conducted.
15812108|NCT04349930|Drug|Cannabidiol vaginal suppository|Cannabidiol vaginal suppository
15812109|NCT04349930|Drug|Placebo vaginal suppository|Placebo vaginal suppository
15812110|NCT04349917|Drug|Methylphenidate|A single, low dose of methylphenidate (0.3 mg/kg) will be administered on the drug day.
15812111|NCT04349917|Other|Placebo|A matching placebo pill will be administered on the placebo day.
15812112|NCT04349904|Diagnostic Test|Near-Focus Narrow Band Imaging|High Definition White Light Endoscopic Imaging followed by Near-Focus Narrow Band Imaging and target biopsy of 6 areas of the duodenum (2 from the first part and 4 from the second part of the duodenum)
15812113|NCT04349891|Device|Transcutaneous Electroacupuncture|Weak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions.
15812114|NCT04349891|Device|Sham TEA|Sham will be delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions.
15812115|NCT04349878|Diagnostic Test|gingival crevicular fluid evaluation|anaysis of interleukins in gingival crevicular fluid
15812116|NCT04349852|Behavioral|BrainHQ Cognitive Training Modules|The BrainHQ is a computerized training program developed from Posit Science designed to improve multiple cognitive domains. The subtests exercises include 3 modules for the experimental group: 1) Sound Sweeps: which is identify whether sound pitches are going up or down; 2) Memory Grids: matching pairs of words; and 3) Syllable Stack: recognition of sequences of confusable syllables. Since the intervention is presented both visually and verbally through the computer, noise cancelling head phones will also be provided to the participants.
15812117|NCT04349852|Behavioral|BrainHQ People Skills Modules|The BrainHQ is a computerized training program developed from Posit Science designed to improve multiple cognitive domains. The BrainHQ will provide 3 training modules for the control group: 1) Recognition: a picture of a face is presented briefly and then the subject picks the recognized face from 3 pictures. 2) Face to Face: matching the emotional expression of 3 pictures to the emotional expression of the picture previously presented; 3) Face Facts: recalling 3 facts about a person that was previously presented. Participants will spend 45 minutes at each training session. Since the intervention is presented both visually and verbally through the computer, noise cancelling head phones will also be provided to the participants.
15812118|NCT04349839|Device|Acrodat software|Acrodat is a newly developed software medical device to access disease activity in acromegaly based on five parameters: IGF-I, tumour size, comorbidities, symptoms and quality of life.
15812119|NCT04349826|Drug|Azithromycin|Azithromycin 20 mg/kg/day for 7 days
15812120|NCT04349826|Drug|Cefixime|cefixime 20-30 mg/kg/day for 7 days
15812121|NCT04349826|Drug|Placebo|cefixime-matched placebo for 7 days
15812122|NCT04349800|Drug|KVD900|Active
15812123|NCT04349800|Drug|Placebo to KVD900|Placebo
15812124|NCT04349787|Other|Computer-aided diagnosis (CADx)|Optical diagnosis of colorectal polyps made with computer-aided diagnosis (CADx) using state-of-the-art machine learning methods and deep learning architectures.
15812125|NCT04349787|Other|BLI Adenoma Serrated International Classification (BASIC)|Optical diagnosis of colorectal polyps made with BLI Adenoma Serrated International Classification (BASIC), both by exert endoscopists and novices.
15812126|NCT04349774|Drug|Control Group - ESP block with SAP block|None - Control Group
15812127|NCT04349774|Drug|Treatment Group - ESP block with SAP normal saline|Substitution of normal saline in place of 0.375% Bupivacaine in SAP block
15812128|NCT04349761|Drug|MyMD1|Isomyosamine 5mg capsules
15812129|NCT04349761|Drug|Placebo|Placebo
15812130|NCT04349748|Behavioral|Health education, and regular HIV and STDs testing prompting service|Health education through app for once a week, and regular HIV and STDs testing prompting service (every month through app) are given to the participants at the beginning of the study and last for the whole five observation periods.
15812131|NCT04349748|Behavioral|Health status inquiry through app (partner notification)|The permission to query health status through app (partner notification) is given to participants (participants can query their potential sexual partner's status of HIV, syphilis, hepatitis B, and hepatitis C respectively through app) at the specific observation period,and the permission is retained until the end of study.
15812132|NCT04349735|Other|Assessment of inhalation technique|Assessment of inhalation technique by 3 methods in every patient
15812133|NCT04349722|Drug|Hyoscine Butylbromide|Intervention is given once a participant is in established labor
15812134|NCT04349722|Other|Placebo|Intervention is given once a participant is in established labor
15812135|NCT04349709|Behavioral|Brief school-based DBT-A|The intervention is inspired to Dialectical Behavior Therapy for Adolescents (DBT-A) (Rathus & Miller, 2015, Mazza et al, 2016; Cappelluccio, 2019). It consists in four monthly 2-hour sessions (for a total of 8 hours) scheduled during school-time. All the sessions are conducted by two psychotherapists trained about DBT. During the sessions, the model of emotions is described through a role-play between conductors. Subsequently, teens are trained about main emotional regulation skills. Moreover, basic elements of distress tolerance, mindfulness and interpersonal efficacy are introduced too.
15812208|NCT04349111|Radiation|Intra-operative Radiation Therapy - IORT|Single dose of 20 Gy
15812209|NCT04349098|Drug|Selinexor|Participants will receive 20 mg of selinexor.
15812210|NCT04349098|Other|Placebo|Participants will receive 20 mg of placebo matched to selinexor.
15812136|NCT04349696|Drug|Mitiglinide|"Day 1: one tablet of Mitiglinide 10mg with 240 ml of water approximately 5 mins before breakfast. An indwelling non-heparin catheter will be placed in an antecubital vein of the forearm or direct venipuncture will be adopted for blood sample collection at belowing time point:
~For PK evaluation:
~-30 (Predose), 5, 10, 15, 20, 30 min, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, 8.0, 9.0, 10 hr post dose (a total of 17 samples per subject)
~For PD evaluation:
~-30 (Predose), 15, 30 min, 1.0, 1.5, 2.0, 3.0, 4.0 hours post dose (a total of 8 samples per subject)"
15812137|NCT04349683|Drug|Jinshuibao|6 capsules at a time, 3 times a day (tid).
15812138|NCT04349683|Drug|Placebo|6 capsules at a time, 3 times a day (tid).
15812139|NCT04349670|Procedure|GPOEM - gastric per-oral endoscopic myotomy|Endoscopic section of the pyloric muscle with submucosal tunnel technique.
15812140|NCT04349657|Device|Supera Peripheral Stent System treatment group|Percutaneous endovascular stenting with the Supera Peripheral Stent System
15812141|NCT04349657|Procedure|Endarterectomy treatment group|Surgical treatment through endarterectomy
15812142|NCT04349644|Behavioral|SENSE Theatre|A peer-mediated, theatre-based intervention that involves 10 sessions of approximately 3 hours each that culminates in a public performance.
15812143|NCT04349631|Biological|HB-adMSCs|Five IV infusion of autologous adipose-derived mesenchymal stem cells. Baseline laboratory values will be collected prior to first infusion and compared at following visits. Safety labs will be assessed at weeks 6, 14, 26. Inflammatory markers will be assessed at weeks 6, 14, 26. SF-36 and PHQ-9 questionnaires will be assessed at weeks 2,6,10,14,18,22,26.
15812144|NCT04349618|Other|PROTECTIVE VENTILATION|Protective ventilation with tidal volume 6 mL/kg of predicted body weight further adjusted to keep plateau pressure below 30 cm H2O and pH above 7.20, and PEEP set using the PEEP FiO2 table of the ARMA trial
15812145|NCT04349618|Other|ULTRAPROTECTIVE VENTILATION|Ultraprotective ventilation with tidal volume reduction down to 4 mL/kg further adjusted to keep plateau pressure below 30 cm H2O and pH above 7.20, and PEEP set using the PEEP FiO2 table of the ARMA trial
15812146|NCT04349605|Behavioral|Meditation|Meditation involves guided breathing and mindfulness training.
15812147|NCT04349605|Behavioral|Kundalini Yoga|Kundalini Yoga involves stretching, guided breathing and meditation
15812148|NCT04349592|Drug|Hydroxychloroquine|Hydroxychloroquine 200 mg tablet oral, one tablet three times a day for 7 days
15812149|NCT04349592|Drug|Azithromycin|Azithromycin 250 mg capsules oral, 2 capsules on day one, followed by 1 capsule once a day for days 2-5.
15812150|NCT04349592|Other|Placebo Tablet|Oral, one tablet three times a day for 7 days
15812151|NCT04349592|Other|Placebo capsules|Oral 2 capsules on day one, followed by 1 capsule once a day for days 2-5.
15812152|NCT04349579|Drug|Rifamycine|Local anesthesia was obtained using 2 ml articaine hydrochloride 40 mg/ml with epinephrine 0.01 mg/ml . The horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under sterile saline irrigation. Following the extraction, granulation tissues were removed, and bleeding was controlled. Finally, extraction socket was irrigated with the solution which contains 250 mg rifamycine and the mucoperiosteal flap was repositioned by 3.0 silk sutures.
15812153|NCT04349579|Drug|Saline Solution|Local anesthesia was obtained using 2 ml articaine hydrochloride 40 mg/ml with epinephrine 0.01 mg/ml . The horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under sterile saline irrigation. Following the extraction, granulation tissues were removed, and post extraction cavity was irrigated with saline solution. After the bleeding was controlled, the mucoperiosteal flap was repositioned by 3.0 silk sutures.
15812154|NCT04349553|Biological|ZH9PA and ZH9|150mL vaccine for oral administration
15812155|NCT04349553|Biological|Placebo|150mL vaccine for oral administration
15812156|NCT04349553|Biological|ZH9PA|150mL vaccine for oral administration
15812157|NCT04349540|Other|no intervention|no intervention
15812158|NCT04349527|Procedure|Round-block Oncoplastic Breast Conserving Surgeries|We de-epithelize the gap between the double round-lines, and we dissect the dermis from the best localization where we can reach the tumor. If the tumor located close to the skin then we are not performing de-epithelization, we excise it with the skin. We mark every wall of the tumor bed with clips. We dissect the surrounding parenchyma- so called parenchyma pillars- from the pectoral fascia and the skin, and we mobilize it. The line under the skin means, the layer under the subcutis, above the superficial fascia, so gives appropriate blood supply to the skin. After this the incision line should be placed 5 mm from the outer round line, so a dermis pillar should be left, and the skin is dissected from the parenchyma as needed. The outer round line should be tightened with a non-absorbable running Benelli suture to fit the areola then interrupted sutures placed to make tensionless the running intracutaneous suture.
15812159|NCT04349527|Procedure|Retroglandular Oncoplastic Breast Conserving Surgeries|We incise the skin slightly lateral in the IMF, around 7 cm long. We dissect with electrocauther the parenchyma with the pectoral fascia from the pectoralis major muscle at least until the mamilla. We incise the fascia along with the parenchyma which contains the tumor and macroscopically 10 mm safe zone. If the tumor is palpable, we turn the parenchyma slightly inside-out, if not, we localize it at the maximum measurement detected according to the ROLL labeling. After marking the tumor bed, we directly adapt the surrounding parenchyma pillars with absorbable sutures, or inverting sutures, or if it requires, we adapt the tumor bed with so-called dual plane mobilization. After revision, we close the fascia with absorbable running suture over the Redon drain then subcutaneous running suture with absorbable suture and finally intracutaneous skin closure.
15812160|NCT04349514|Other|Natural history|Longitudinal observation of neuroimaging, clinical, and blood markers.
15812161|NCT04349501|Other|Restriction Spectrum Imaging Magnetic Resonance Imaging|RSI is a multicompartment model of diffusion MRI that uses data acquired at multiple b-values to distinguish varied diffusion speeds (restricted intracellular, hindered extracellular, and approximately free diffusion).
15812162|NCT04349488|Device|Anodal Transcranial Direct Current Stimulation|Subjects received a micro-current through their scalp to induce cortical and subcortical changes
15812163|NCT04349475|Dietary Supplement|Intervention Omega 3 Supplementation|Participants will supplement 4g of Omega 3 fish oil daily (750DHA/250EPA)
15812164|NCT04349475|Dietary Supplement|Control Safflower Oil|Participants will consume 2.5g of a Safflower oil supplement daily
15812165|NCT04349462|Diagnostic Test|VideoFlurosocopy Swallow Study|VFSS is a radiological examination that can identify the presence, nature and severity of any abnormalities in oropharyngeal, laryngeal and upper esophageal swallow physiology. The VFSS will be administered via a standardized protocol by a registered speech-language pathologist (SLP). During the VFSS, the patient is seated upright and swallows a variety of consistencies (eg. liquids, semisolids and solids) and volumes of barium-coated foods. A dynamic fluoroscopic image will be digitally captured and recorded.
15812166|NCT04349462|Diagnostic Test|Water Sip Test|The steps of the water sip test include; 1. The patient will be given 5 ml of water, and if tolerated 20 ml followed by 50 ml of water (thin fluid) and the patient is assessed for cough/chocking during or after swallowing, wet or weak cough after swallowing. 2. The patient is asked to produce sustained vowel /a/ before and after swallowing of water and voice change after swallowing will be observed and recorded.
15812167|NCT04349436|Biological|RP1, intra-tumoral injection, oncolytic virus|Genetically modified herpes simplex type 1 virus
15812168|NCT04349423|Behavioral|Social Media Usage Manipulation|Behavioral Intervention of social media usage.
15812169|NCT04349410|Drug|Hydroxychloroquine, Azithromycin|FMTVDM Planar, SPECT, PET
15812170|NCT04349410|Drug|Hydroxychloroquine, Doxycycline|FMTVDM Planar, SPECT, PET
15812171|NCT04349410|Drug|Hydroxychloroquine, Clindamycin|FMTVDM Planar, SPECT, PET
15812172|NCT04349410|Drug|Hydroxychloroquine, Clindamycin, Primaquine - low dose.|FMTVDM Planar, SPECT, PET
15812173|NCT04349410|Drug|Hydroxychloroquine, Clindamycin, Primaquine - high dose.|FMTVDM Planar, SPECT, PET
15812174|NCT04349410|Drug|Remdesivir|FMTVDM Planar, SPECT, PET
15812175|NCT04349410|Drug|Tocilizumab|FMTVDM Planar, SPECT, PET
15812176|NCT04349410|Drug|Methylprednisolone|FMTVDM Planar, SPECT, PET
15812177|NCT04349410|Drug|Interferon-Alpha2B|FMTVDM Planar, SPECT, PET
15812178|NCT04349410|Drug|Losartan|FMTVDM Planar, SPECT, PET
15812179|NCT04349410|Drug|Convalescent Serum|FMTVDM Planar, SPECT, PET
15812180|NCT04349397|Behavioral|Medication Tracking Form|Parents will complete medication tracking form for 5 days after child's surgery. They will track medications administered, pain scores, nausea and vomiting
15812181|NCT04349384|Procedure|Colorectal resection|Colon or rectal resection for colorectal adenocarcinoma
15812182|NCT04349371|Drug|Chloroquine|Subjects will take two tabs of 250mg for every day for one week and then two tabs of 250mg for 1 day a week thereafter for study duration of 3 months). Subjects with severe GI intolerance can take 1 tablet of 250mg daily for the first week and 1 tablet per week for the remainder of the 3 month study duration.
15812183|NCT04349371|Drug|Placebo oral tablet|Subjects will take two tabs of placebo for every day for one week and then two tabs of placebo for 1 day a week thereafter for study duration of 3 months).
15812184|NCT04349358|Other|FDG and FCH PET/CT|"during the initial myeloma check-up : FDG and FCH PET/CT exams (maximum 21 days after inclusion)
~just before maintenance treatment, respecting a minimum interval of 2 weeks after the last course of chemotherapy : FDG and FCH PET/CT exams"
15812185|NCT04349345|Diagnostic Test|sperm count|total progressive sperm motile count
15812186|NCT04349332|Device|Helmet non-invasive ventilation (NIV)|After application of the helmet, arterial blood gas sampling will be utilized to follow gas-exchange; Noninvasive support will be reduced progressively in accordance to clinical improvement and will be discontinued if patient maintains respiratory rate <30breaths/min and PaO2 >75mm Hg with FiO2 0.5 without ventilatory support. If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay.
15812187|NCT04349319|Device|Digital preoperative planning|Before the osteosynthesis of distal humerus fracture, we perform digital preoperative planning.
15812188|NCT04349306|Drug|RASBURICASE SR29142|Pharmaceutical form:solution for infusion Route of administration: intravenous
15812189|NCT04349293|Procedure|Tissue sampling|Collection of a sample of tumor tissue and a sample of adjacent or counter lateral healthy tissue (if possible) from the surgical room
15812190|NCT04349293|Procedure|Blood sampling|Collection of a 30mL peripheral blood sample in heparin at several times: during surgical and medical treatment (before surgery, before the start of mAbs and after mAbs)
15812191|NCT04349280|Drug|Bintrafusp alfa|Participants will receive bintrafusp alfa 1200 mg, IV infusion, Q2W until PD, death, unacceptable toxicity, study withdrawal or up to 2 years.
15812192|NCT04349267|Biological|BMS-986315|Specified dose on specified days
15812193|NCT04349267|Biological|nivolumab|Specified dose on specified days
15812194|NCT04349267|Biological|cetuximab|Specified dose on specified days
15812195|NCT04349254|Device|Corneal treatment by a low vision aid device|Near infrared light is used to irradiate the cornea to change the modulus of small volumes of anterior stroma. The change of modulus produces a change of corneal stiffness and shape that modifies the distribution of light onto the retina. Light rays are redirected from dysfunctional areas of the retina that have been damaged by age-related macular degeneration (AMD) to functional areas of the retina, thereby improving patient vision.
15812196|NCT04349241|Drug|favipiravir|pyrazine carboxamide derivative (6-fluoro-3-hydroxy-2-pyrazinecarboxamide), a new type of RNA-dependent RNA polymerase (RdRp) inhibitor
15812197|NCT04349241|Drug|Standard of care therapy|oseltamivir 75 mg 12 hourly for 5-10 days and hydroxychloroquine 400mg 12 hourly day -1 followed by 200mg 12 hourly daily on day- 2 to day-5-10
15812198|NCT04349228|Drug|Hydroxychloroquine (HCQ)|Hydroxychloroquine (HCQ) 200mg/day
15812199|NCT04349228|Drug|Placebo oral tablet|Placebo of Hydroxychloroquine (HCQ) without any active substance
15812200|NCT04349202|Diagnostic Test|EUROIMMUN assay|Serology testing to detect SARS-CoV-2 antibodies
15812201|NCT04349176|Drug|Dose|Randomized to either 100U or 155U
15812202|NCT04349163|Other|Questionnaire|CD-RISC 25 questionnaire
15812203|NCT04349150|Device|Virtual reality|Intervention consists of providing virtual reality in place of standard sedatives and narcotics for a portion or the duration of the colonoscopy
15812204|NCT04349137|Device|HD-tACS|non-invasive high-definition dual-site transcranial alternating current stimulation (HD-tACS) low intensive electrical alternating currents (2 mA peak-to-peak) are externally applied to the skull at a frequency of 6Hz to entrain endogenous neural oscillatory activity.
15812205|NCT04349137|Device|sham HD-tACS|sham non-invasive high-definition dual-site transcranial alternating current stimulation (HD-tACS)
15812211|NCT04349085|Device|Effective PBMT/sMF|A cluster with 20 diodes, manufactured by Multi Radiance Medical® (Solon, OH, USA), will be used: 4 diodes of 905 nm (1.25 average power, 50 W of peak power for each diode), 8 diodes of 850 nm (40 mW of average power for each diode) and 4 diodes of 633 nm (25 mW average power for each diode). Effective PBMT/sMF will be applied in direct contact with the skin and light pressure in: 4 sites in the knee extensor/hip flexor muscles, 3 sites in the knee flexor/hip extensor muscles and 1 site in the plantar flexor muscles. The effective PBMT/sMF will be applied to both lower limbs. The dose used for applications will be approximately 270 J for knee extensors/hip flexors, 180 J for knee flexors/hip extensors, and 60 J for plantar flexors.
15812212|NCT04349085|Device|Placebo PBMT/sMF|A cluster manufactured by Multi Radiance Medical® (Solon, OH, USA) with 20 diodes will be used: Placebo PBMT/sMF will be applied in direct contact with the skin and light pressure in: 4 sites in the knee extensor/hip flexor muscles, 3 sites in the knee flexor/hip extensor muscles and 1 site in the plantar flexor muscles. The placebo PBMT/sMF will be applied to both lower limbs. The dose used for applications will be approximately 0 J per diode. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (active or placebo).
15812213|NCT04349072|Drug|Mavacamten|Mavacamten Capsules Other names: MYK-461
15812214|NCT04349072|Drug|Placebo|Placebo
15812215|NCT04349059|Other|Animal based diet|Food will be provided by Montefiore-Einstein Food Services
15812216|NCT04349059|Other|Plant based diet|Food will be provided by Montefiore-Einstein Food Services
15812217|NCT04349046|Device|Total hip arthoplasty (THA)|Total hip arthroplasty (THA) is a common operative treatment where an arthritic, degenerative or fractured hip joint is replaced with a prosthetic device if conservative options are unable to relieve pain and debilitating symptoms. THA was traditionally performed on patients over 60 years old, but now includes young and active patients, as well as very old ones thanks to the continuous improvement in implant design. Major indications of THA include osteoarthritis, rheumatoid arthritis, avascular necrosis and hip fractures. The THA surgical procedure involves replacing the head of the femur and acetabulum or socket with an artificial prosthesis. This system is composed of a femoral stem that is inserted into the femoral canal, a ball that attaches to the femoral stem, and an acetabular component or shell that replaces the acetabulum.
15812218|NCT04349033|Behavioral|Emotional Disclosure and Brain Education|Patients are interviewed about a number of aspects of their lives (stress, other illnesses, personality, adverse childhood experiences), and these are explored as part of education of the brain's role in their pain.
15812219|NCT04349033|Behavioral|Emotional Disclosure Only|Patients are interviewed about a number of aspects of their lives, but without brain education
15812220|NCT04349033|Behavioral|Pain Information Control|Patients are interviewed about their pain history and other basic, non-disclosure information about their health.
15812221|NCT04349007|Dietary Supplement|Standard meal|local porridge with a vitamin and mineral sprinkle powder that will be mixed in after cooking
15812222|NCT04349007|Dietary Supplement|School food ready-to-use|80 gram per day sachet containing peanut paste with oil, sugar, cowpea, maize, and vitamin and minerals
15812223|NCT04349007|Dietary Supplement|School food ready-to-use plus Milk|80 gram per day sachet containing peanut paste with oil, sugar, cowpea, non-fat dried milk and vitamin and minerals
15812224|NCT04348994|Device|Non-ablative thermal-only Er:YAG laser therapy|"Each patient will receive 3 sessions of Er:YAG laser treatment for SUI (IncontiLase®).
~Single-session treatments will be offered to patients after 18, 24 and 30 months following the initial three sessions."
15812225|NCT04348981|Device|Wearable fitness tracking device|Patients having a wearable fitness tracking device will be monitored for their level of activity after surgery. Declines in activity level will prompt a phone call from the surgical provider.
15812226|NCT04348968|Device|Total hip arthroplasty|"The THA surgical procedure involves replacing the head of the femur and acetabulum or socket with an artificial prosthesis. This system is composed of a femoral stem that is inserted into the femoral canal, a ball that attaches to the femoral stem, and an acetabular component or shell that replaces the acetabulum.
~In this study, the acetabular component is the Zimmer Maxera Cup, which is a monoblock construct consisting of a pre-assembled shell and liner. The ceramic liner articulates with a ceramic femoral head for a ceramic-on-ceramic large diameter head articulation. The Maxera Cup is intended for single use only and is designed for reconstruction of the hip joint for conditions described in the inclusion and exclusion section of this protocol."
15812227|NCT04348955|Behavioral|Women between 18 and 70 years old with an adjuvant breast cancer histologically characterized|"Quality of life and anxiety questionnaires before the course of chemotherapy (C1 and C4).
~Touch-Massage during the course of chemotherapy (from C1 to C3) Anxiety questionnaire at the end of the course of chemotherapy (from C1 to C3)"
15812228|NCT04348929|Other|Self-administered questionnaires|Self-administered questionnaires once during the post-natal hospitalization and a second time 7 to 9 weeks after the delivery (at home)
15812229|NCT04348916|Biological|ONCR-177|Intratumorally administered oncolytic immunotherapy comprised of a genetically engineered HSV-1
15812230|NCT04348916|Biological|pembrolizumab|Anti-PD-1 monoclonal antibody
15812231|NCT04348903|Behavioral|Virtual Reality Distraction|The researchers will prepare the VR device. The researches will explain the aim of using VR and adopt tell-show-do technique in introducing VR Glasses. Once VR device headset will be adapted to the child's head size and adjusted in front of his/her eyes, the selected 3D cartoon movie will be played in the waiting room and throughout the procedure of dental LA injection. After ensuring that the child is fully immersed in the cartoon movie, a needle of local anesthetic agent will be prepared and injected after explanation of the procedure.
15812232|NCT04348903|Behavioral|Positive Pre-Visit Imagery Intervention|Short narrative visual information regarding the dental chair, environment and equipment will be provided. It will be done through showing children an interactive book that contained photographs of A4 size, depicting three children model aged 4 - 6 years who are smiling while sitting in the dental chair and cooperative with the dentist. Benefit of LA in alleviating pain will be explained. The researchers also will explore the children's reflection of the children model and allow them ask questions relevant to LA injection.
15812233|NCT04348890|Drug|Vamorolone 4% suspension for oral dosing|vamorolone 6 mg/kg/day orally once daily for 8 weeks.
15812387|NCT04347447|Other|Exercise training|All groups will complete a supervised 12-week resistance training protocol, 3 days per week.
15812234|NCT04348877|Other|Antibody-Rich Plasma from COVID-19 recovered patients|400 millimeter of Antibody-Rich Plasma from COVID-19 recovered patients will be transfused to patients with severe or immediately life-threatening COVID-19
15812237|NCT04348851|Behavioral|Caregiver problem-solving|Registered nurses will conduct the combined Internet and telephone intervention condition. The intervention is based on the relational/problem-solving model of stress originally developed by D-Zurilla and Nezu. The investigators will modify the traditional, problem-solving intervention by adding web-based training using interactive modules, factsheets, and tools on our national RESCUE Stroke Caregiver website. (http://www.cidrr8.research.va.gov/rescue
15812238|NCT04348851|Behavioral|Attention Control|The RNs will only provide active listening and paraphrasing. The RNs will ask caregivers to talk about their caregiver experiences. The nurses will not provide advice, but rather direct caregivers to access information on the Caregiver Family Alliance website (www.caregiver.org) for managing problems or to contact their healthcare
15812239|NCT04348825|Device|Electroconvulsive therapy|
15812240|NCT04348812|Behavioral|ABMT|mobile attention bias modification training for anxiety, using the app Personal Zen
15812241|NCT04348812|Other|Transcranial direct current stimulation|Soterix 1X1 tDCS Limited Total Energy (LTE) Stimulator
15812242|NCT04348799|Other|BPD|It is a observation research.we didn't intervene anything.
15812243|NCT04348786|Drug|Doxycycline|Doxycylcine 100 mg bid ,esomprazole 20 bid,Bismuth subsalicylate 262 tab.2 tab q.i.d,Tinadizole 500 bid
15812244|NCT04348786|Drug|Levofloxacin 500mg|Levofloxacin 500 mg qd, amoxicillin 500 2cab bid,Tinadizole 500 bid, esomprazole 20 bid
15812245|NCT04348773|Procedure|Dehydration|Dehydration of the natural tooth by tooth isolation
15812246|NCT04348773|Procedure|Rehydration|Rehydration
15812247|NCT04348760|Behavioral|Rotation Diet|Based on the food-specific IgG measurement and relative distribution, a personalized food profile was created for each subject identifying 1 to 3 relevant food groups/nutritional clusters. Subjects were then instructed to avoid the foods highlighted in their personal food profile in certain days of the week, and to assume them in 7 of the 21 meals of the week. No calorie restriction was imposed in the diet.
15812248|NCT04348747|Biological|Anti-HER2/HER3 Dendritic Cell Vaccine|Given ID
15812249|NCT04348747|Drug|Celecoxib|Given PO
15812250|NCT04348747|Biological|Pembrolizumab|Given IV
15812251|NCT04348747|Biological|Recombinant Interferon Alfa-2b|Given IV
15812252|NCT04348747|Drug|Rintatolimod|Given IV
15812253|NCT04348734|Diagnostic Test|pleural ultrasound|Patients will benefit from a daily pleural ultrasound for 96 hours, D1 being the day of hospitalization. The therapeutic course of action will depend on the presence or not, and on the type of pleural effusion according to a pre-established algorithm
15812254|NCT04348721|Other|online survey|"An online survey including 8 case-vignettes was sent to international liver transplant surgeons who had published on liver transplantation. The first part is related to surgeon's own experience. In the second part, the surgeons were asked to rate the difficulty of various situations in liver transplantation on a scale of 1 to 10 (level 1 was labeled as easier, and level 10 was labeled as difficult). In the third part, 8 case-vignettes corresponding to 8 clinical real-life situations are submitted to experts"
15812255|NCT04348708|Genetic|HMI-102|HMI-102 is an AAVHSC15 vector containing a functional copy of the human PAH gene
15812256|NCT04348695|Drug|Ruxolitinib plus simvastatin|"Ruxolitinib 5 mg orally every 12 hours for 7 days, which will be increased to 10 mg every 12 hours for a total of 14 days.
~Simvastatin 40 mg orally every 24 hours for 14 days"
15812257|NCT04348695|Other|Standard of Care|Patients will receive treatment according to usual clinical practice in the participant site.
15812258|NCT04348682|Diagnostic Test|Positron Emission Tomography (PET) Imaging|A single dose activity of 5 mCi (accepted range of 3-7 mCi) of 68Ga-PSMA-11 will be intravenously administered to patient as a bolus injection. After 50-100 minutes of uptake time, the patient will undergo a whole body (skull to mid-thighs) PET/CT imaging.
15812259|NCT04348669|Other|Tele-yoga|Subjects will undergo 30-minute yoga sessions delivered remotely 2 times/week for 6-weeks. The yoga sessions will be delivered one-on-one. The sessions will include 5-7 minutes of breathing exercises, 15-20 minutes of postures, and 5-7 minutes of relaxation and meditation exercises.
15812260|NCT04348656|Biological|Convalescent plasma|Patients will receive 500 mL of convalescent plasma (from one single-donor unit of 500 mL or 2 units of 250 mL from 1-2 donations) collected by apheresis from donors who have recovered from COVID-19 and frozen (1 year expiration date from date of collection). The plasma unit will be thawed as per standard blood bank procedures and infused into the patient slowly over 4 hours. When administering 2 units of 250 mL, the 2nd unit will be administered after the first, and no longer than 12 hours later. The patient will be monitored for adverse events as per each site's policies.
15812261|NCT04348643|Biological|CEA CAR-T cells|CEA-CAR-T cells will be administered intravenously.
15812262|NCT04348630|Other|Simulated heatwave exposure|Older adults are exposed to a 8-hour simulated exposure
15812263|NCT04348617|Other|Moderate exercise|50 minutes of moderate exercise on treadmill
15812264|NCT04348617|Other|Rest|50 minutes of rest or sedentary activity
15812296|NCT04348344|Behavioral|pulmonary rehabilitation|"Patients receive health education of pulmonary rehabilitation, using the home-based rehabilitation exercise prescription, taking home exercise as the main form, using the sports bracelet and special respiratory rehabilitation app software, the home management system integrating home rehabilitation training, detection and feedback is mainly adopted, which is a combination of aerobic endurance training: walking, intermittent strength training: elastic band and inspiratory muscle training:apparatus, abdominal breathing training."
15812297|NCT04348331|Diagnostic Test|Dual echo MRI sequence|new MRI sequences for imaging of joints
15812265|NCT04348604|Behavioral|Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA)|"Customized Adherence Enhancement for Adolescents and Young Adults (CAE-AYA): CAE-AYA participants will have 4 core in-person sessions (45-60 minutes each) spaced about 1 week apart over a period of approximately 4 weeks and one booster in-person session approximately 4 weeks after completion of the 4 core sessions (total of up to 5 in-person sessions spaced out over 8 weeks). There will be one follow-up phone call with a study interventionist, approximately 6 weeks post-baseline (timed half-way between completion of the core sessions and the booster session). All AYAs assigned to the CAE-AYA arm will receive all 4 modules (Psychoeducation on BD Medications; Communication with Providers & Caregivers; Medication Routines; and Targeting Risky Behavior via Modified Motivational Enhancement Therapy (MET)), with the content within each module being customized to developmental stage and behavioral experience."
15812266|NCT04348604|Behavioral|Enhanced Treatment as Usual (ETAU)|Enhanced Treatment as Usual (ETAU): ETAU will consist of usual clinical care with prescribing clinicians and therapists, augmented by written materials specific to BD for AYAs and 6 follow-up telephone calls to briefly review the materials and be available for questions by social workers with mental health experience and at least some experience in working with AYA with BD. In order to ensure that there is not treatment contamination, different trained interventionists will be used for CAE and eTAU. Therapists will briefly review the materials and be available for questions during the phone calls. Materials will cover general self-management in BD. The calls will be relatively brief (maximum of 20-30 minutes).
15812267|NCT04348591|Behavioral|Cognitive Restructuring|All participants will learn how to change their thinking in order to be less upset when confronted with stressors
15812268|NCT04348591|Device|neurostimulation|all participants will receive inhibitory, excitatory, and sham transcranial magnetic stimulation over different neural targets during the experimental session. The purpose of the neurostimulation is not treatment, but causal interference/enhancing of brain circuitry to identify candidate neural regions for future interventions
15812269|NCT04348578|Other|QMix 2in1|In QMix 2in1 group root canals were irrigated with Mix as a final irrigation.
15812270|NCT04348565|Other|Diabetes Care Programme|20-week Diabetes Care Programme consists of three Diabetes Conversation Map sessions in 8 weeks with 3-4 weeks intervals, then two teleconsultations at week 12th and week 16th
15812271|NCT04348552|Other|Primary care professionals reports of potential patient safety incidents, non-COVID-19 related|Primary care professionals reports of potential patient safety incidents, non-COVID-19 related
15812272|NCT04348539|Other|Balance training|32 sessions will be held twice a week, with each session taking an average of 45 minutes
15812273|NCT04348526|Procedure|Corticision|Surgical intervention is going to be used in the interdental areas between the lower anterior teeth to accelerate tooth movement. Three incisions are going to be made
15812274|NCT04348526|Procedure|Traditional orthodontic treatment|No surgical intervention will be used, just normal orthodontic sequence of procedures.
15812275|NCT04348513|Drug|T3 solution for injection|For example, for a patient of 77Kg of weight, a dose of 6ml (60 μg) will be administered as a bolus intravenously over 2-3 min within 60 min of respiratory support initiation. Then, the patient for the next 24 hours will receive 21ml of the product (total of 210 μg of T3) that will be diluted in NaCl 0.9% and administered with a pump at a steady flow rate of 10.4 ml/h for a total duration of 48 hours. From day 3 till successful weaning or end of follow-up, the patient will receive 50% of this dose, 10.5 ml of the product (total of 105 μg of T3) that will be diluted in NaCl 0.9% and administered with a pump at a steady flow rate of 5.2 ml/h.
15812276|NCT04348513|Drug|Placebo|Same as with T3 solution for injection.
15812277|NCT04348500|Drug|Clazakizumab|Infusion
15812278|NCT04348487|Other|Modified cephalica venous access|This modified technique prioritized the safety in TIVAPS by using several modified landmarks and techniques. The catheter was inserted through cephalic vein in deltopectoral groove regio and implanted the port in the anteromedial of thorax. Generally, the percutaneous and Seldinger technique was used to ensure safety and minimal tissue disruption. To connect the trimmed catheter to port pocket, the author anchored a special trocar from anteromedial of thorax to the deltopectoral groove for guidance.
15812279|NCT04348474|Drug|Hydroxychloroquine Sulfate|All patients included in the study will receive HCQ (400 mg BID on D1 and 400 mg/day on D2 to D7) for 7 days.
15812280|NCT04348474|Drug|Azithromycin Tablets|All patients included in the study will receive AZT 500 mg per day for 5 days.
15812281|NCT04348461|Drug|Allogeneic and expanded adipose tissue-derived mesenchymal stromal cells|Two serial doses of 1.5 million adipose-tissue derived mesenchymal stem cells per kg
15812282|NCT04348448|Drug|Canakinumab 150 MG/ML [Ilaris]|COVID-19
15812283|NCT04348435|Biological|HB-adMSCs|Hope Biosciences allogeneic adipose-derived mesenchymal stem cells
15812284|NCT04348435|Other|Placebos|Saline
15812285|NCT04348422|Diagnostic Test|COVID-19 RT-PCR|Nasoropharyngeal swabs for COVID-19 RT-PCR - initial screening/retest +every 10 days in 100 days followup period
15812286|NCT04348422|Diagnostic Test|COVID-19 Serology|Blood samples for COVID-19 serology - initial screening/retest +every 10 days in 100 days followup period Each sample will be examined by 4-6 serology kits.
15812287|NCT04348422|Other|Symptoms questionnare|Symptoms questionnaire which will be filled by participant on initial screening/retest visit + every 10 days in 100 days followup period
15812288|NCT04348409|Drug|Nitazoxanide Tablets|Patients will receive nitazoxanide 600 mg BID for 7 days
15812289|NCT04348409|Drug|Placebo|Patients will receive placebo BID for 7 days
15812290|NCT04348383|Drug|Defibrotide 25 mg/kg 24 hours continuous infusion for 15 days|Defibrotide 25 mg/kg 24 hours continuous infusion for 15 days
15812291|NCT04348383|Drug|Placebo 250 cc 24 hours continuous infusion for 15 days|Placebo 250 cc 24 hours continuous infusion for 15 days
15812292|NCT04348370|Biological|BCG Vaccine|BCG vaccine will be administered by research nurses. Participants and investigators will be blinded.
15812293|NCT04348370|Biological|Placebo Vaccine|Placebo vaccine will be administered by research nurses. Participants and investigators will be blinded.
15812294|NCT04348357|Other|Telemedicine|A video-call application hosted by Texas Tech University Health Science Center El Paso and easily accessible from mobile phones or video-enabled PCs will be used (webex teams)
15812295|NCT04348357|Other|Office visit|Patient comes to the office to receive routine postoperative care
15812329|NCT04348019|Behavioral|Fasting|Fasting was defined as no foods or caloric beverages.
15812298|NCT04348318|Other|health related personal data extraction from digital medical records|health related personal data extraction from digital medical records (i.e. patient characteristics; start, end and duration of hospitalization and ICU stay; admitted from another hospital, nursing home or comes with emergency medical Service; formal data of written advance directives; data of unwritten advance directive; information on the contents of the advance directives (regarding life-worthy conditions, health care agents, resuscitation, pain management, artificial nutrition, hydration, surgeries, renal replacement, mechanical circulation, mechanical ventilation, pacemaker, administration of blood products, treatment of infections, organ donation, autopsy); patient history; clinical data; therapeutic features; outcome at discharge; knowledge regarding relatives and their level of information about the advance directives; discussion of euthanasia and self-determination of dying.
15812299|NCT04348305|Drug|Hydrocortisone|Continuous infusion: 200 mg (104 ml) every 24 hours, Bolus injections: 50 mg (10 ml) every 6 hours, Total treatment duration: 7 days
15812300|NCT04348305|Drug|Sodium Chloride 9mg/mL|Continuous infusion: 104 ml every 24 hours, Bolus injections: 10 ml every 6 hours, Total treatment duration: 7 days
15812301|NCT04348292|Drug|Durvalumab|Given IV
15812302|NCT04348292|Drug|Sirolimus|Given PO
15812303|NCT04348279|Device|propylene mesh|propylene mesh as a palatal stent for palatal wound
15812304|NCT04348266|Device|Radiofrequency ablation (RFA)|Radiofrequency ablation is a device that can generate the heat from radiofrequency for tissue ablation. RFA is a standard treatment for Barrett' esophagus and high grade dysplasia in esophagus.
15812305|NCT04348253|Procedure|Berger|Treatment 1
15812306|NCT04348253|Procedure|3LT|Treatment 2
15812307|NCT04348227|Behavioral|Enhanced hygiene measures|Wether or not hygiene measures dictated by the pandemic of severe acute respiratory syndrome coronavirus 19 , reduce multi drug resistant pathogens isolated in endotracheal aspirates.
15812308|NCT04348201|Other|foot reflexology|foot reflexology session which takes about 20 minutes. The position of the patient during reflexology session was a relaxed comfortable supine lying position. The therapist was sitting position at the level of the feet. The Session of reflexology was done on three points at both feet.
15812309|NCT04348201|Dietary Supplement|dietary modification|diet must be rich in vitamins as fish and beans, calcium as milk and chess, low fat food through decrease oil in meals, high fiber food through all types of vegetables and fruits and restrict caffeine
15812310|NCT04348188|Behavioral|Education program on healthy habits|6-week supervised educational program with 12-month follow-up compared to the same unsupervised intervention
15812311|NCT04348175|Drug|Setmelanotide|Setmelanotide will be administered as a single SC dose of 2.0 mg on Day 1. A dose higher than 2.0 mg will not be used during the study. Dose may be lowered based on safety data.
15812312|NCT04348162|Other|Cocoa flavanols and berries anthocyanins|Effect of cocoa flavanols and berries anthocyanins on cardiovascular and cognitive health
15812313|NCT04348149|Dietary Supplement|Lindera obtusiloba extract|One package of dietary supplement contains one gram of 70% ethanol extracted powder of Lindera obtusiloba and one gram of glucose powder. Participants intake one package per day for 8 weeks.
15812314|NCT04348136|Drug|JR-141|IV infusion, 2.0 mg/kg/week
15812315|NCT04348123|Other|Survey|Survey questionnaire seeks to collect data relevant to mammogram completion, barriers, and facilitators
15812316|NCT04348123|Behavioral|Education Session|After the survey, clinic staff will conduct brief, culturally-appropriate educational session about breast health and mammography delivered by a female public health educator with experience in the underserved community. Educational session will explain screening options and address common barriers
15812317|NCT04348110|Dietary Supplement|Placebo tablets|consume 2 tablets per day for 8 weeks
15812318|NCT04348110|Dietary Supplement|Blueberry Chewable Tablets|consume 2 tablets per day for 8 weeks
15812319|NCT04348097|Device|Activator instrument|activator instrument was placed perpendicular over the identified trigger point and 10 thrusts were delivered, with a rate of one thrust per second
15812320|NCT04348097|Device|dry needle|By wrist flexion and extension movements, the trigger point was needled in different directions and tried to elicit at least one local twitch response during the procedure and patient's familiar referral pain was tried to obtain . Each dry needling procedure lasted 1-2 minutes
15812321|NCT04348071|Drug|Ruxolitinib|Participants will receive 10 mg ruxolitinib twice daily.
15812322|NCT04348058|Behavioral|Telephone recruitment to screening colonoscopy|Utilisation of dedicated call center for recruitment to screening program instead of traditional, paper invitation
15812323|NCT04348058|Behavioral|Combined methods recruitment to screening colonoscopy|Utilisation of dedicated call center for recruitment to screening program in participants, who did not respond to traditional, paper invitation
15812324|NCT04348045|Drug|Arm A - Olaparib|"300 mg orally twice daily, for a total daily dose of 600mg
~Study treatment can be dose-reduced to :
~First step : 250 mg twice daily , for a total daily dose of 500 mg Second step: 200 mg twice daily taken twice daily, for a total daily dose of 400 mg No further dose reduction is allowed, and study treatment should be discontinued."
15812325|NCT04348045|Drug|ARM B - durvalumab plus selumetinib|"Durvalumab administered IV at a flat dose of 1500 mg on day 1 of every 28-day cycle, Selumetinib Starting Dose : 75 mg twice daily
~Study treatment can be dose-reduced to :
~Dose Level -1 : 75 mg once daily Dose Level -2 : 50 mg twice daily Dose Level -3 : 50 mg once daily"
15812326|NCT04348045|Drug|ARM C FOLFIRI|FOLFIRI every two weeks Irinotecan 180 mg/m2 Intravenous (IV) on day 1 Folinic acid 400 mg/m2 IV on day 1, 5-FU 400 mg/m2 IV bolus on day 1 and 2, and 46h IV infusion of 5-FU 2400 mg/m2
15812327|NCT04348032|Drug|PLD 40mg/m2 ivgtt q4w +Apatinib 250mg po qd|Patients receive PLD and apatinib at the same time. The dose of intravenous chemotherapy drug is calculated according to the body surface area, and the dose of oral drug apatinib is 250mg qd. Dose suspension and dose reduction are allowed only when patients have serious adverse reactions. The intravenous chemotherapy drug PLD dose is only allowed to be down-regulated twice (one time is to reduce the standard dose by 25%), and the oral drug apatinib dose is only allowed to be reduced once (250mg gravity QD changed to 250mg gravity Qod). Otherwise the patients will drop out of the study.
15812328|NCT04348032|Drug|PLD 40mg/m2 ivgtt q4w|The dose of intravenous chemotherapy drug is calculated according to the body surface area. When patients have serious adverse reactions, dose suspension and dose reduction are allowed. The PLD dose is only allowed to be down-regulated twice (one time is to reduce the standard dose by 25%).
15812330|NCT04348006|Drug|Bortezomib 3.5 MG|"VCD protocol
~V, Alvocade®: Day 1, 4, 8, 11 (1.3 mg/m2 SC)
~C, Cyclophosphamide: 300 mg/m2 IV over 30 min (day 1, 8, 15)
~D, Dexamethasone oral: 40mg (days 1 to 4)
~VRD protocol:
~V, Alvocade®: Day 1, 4, 8, 11 (1.3 mg/m2 SC)
~R, Lenalid® cap 25 mg po (day 1 to 21)
~D, Dexamethasone oral: 40mg (days 1 to 4)"
15812331|NCT04347980|Drug|Dexamethasone and Hydroxychloroquine|"Patients included in the Hydroxychloroquine / Dexamethasone group will benefit from standardized ventilatory management and administration of Hydroxychloroquine in the same manner as the Hydroxychloroquine group. They will receive in addition to Dexamethasone at a rate of 20 mg intravenously for 15 min once a day for 5 days (D1 to D5) then at a rate of 10 mg per day from D6 to D10. If the patient is extubated before the 10th day, he will receive his last dose of Dexamethasone before."
15812332|NCT04347980|Drug|Hydroxychloroquine|Patients included in the Hydroxychloroquine group will benefit from standardized ventilatory management. Patients included in the Hydroxychloroquine group will receive 200 mg x 3 / day enterally from J1 of the HCQ for 10 days. If the patient is extubated before the 10th day, he will receive his last dose of HCQ before.
15812333|NCT04347967|Biological|UMC119-06|Cohort 1: Low does of UMC119-06；Cohort 2: Medium does of UMC119- 06；Cohort 3: High does of UMC119-06
15812337|NCT04347941|Procedure|Prone Positioning|Patient will be asked to remain for at least one hour and to a maximum total of 16 hours in prone position with 45 minutes breaks for meals. Immediately prior to proning, if spO2 <94% on FiO2 0.4, start on 100% O2 to ensure stability during proning. A nurse or assistant will assist patient to turn on side and then face down with the support of pillows as required for comfort, ensure that they are predominantly on their chest rather than on their side. Arms can be at side, in swimmer position and can be moved to patients' comfort, pillows under knees and chest for comfort and call bell to be at patient's arm's length. Vitals and work of breathing score will be measured before and at 1 hour into each proning session and at the end of each session. Total length of time in prone position will be recorded. Intervention to continue daily until oxygen requirement to maintain spO2 >94% is below FiO2 0.4 via venturi facemask or high flow nasal cannula
15812338|NCT04347941|Procedure|Standard of care.|Standard of care. Prone positioning may be administered as a rescue therapy
15812339|NCT04347915|Drug|Clevudine|Clevudine 120mg once a day for 14 days (up to 21 days)
15812340|NCT04347915|Drug|Placebo|Matching Placebo once a day for 14 days (up to 21 days)
15812341|NCT04347902|Drug|Intravenous Lipid Emulsion|Various types of intravenous lipids
15812342|NCT04347889|Drug|Hydroxychloroquine|Oral loading dose followed by once weekly dosing
15812343|NCT04347889|Other|Vitamin C|Once daily vitamin C 1 gm
15812344|NCT04347876|Diagnostic Test|Tuberculin test|Test the delayed hypersensitivity reaction and immunity to previous BCG vaccination
15812345|NCT04347863|Other|Group swallowing disorder diet preparation program|This program included food properties, select food, type of cooking, using thickener and tasting
15812346|NCT04347850|Other|blood sample|Collection
15812347|NCT04347837|Device|Titan SGS stapler|Stapler for the longitudinal resection of the stomach
15812348|NCT04347811|Behavioral|Death Cafe|Death Cafés are a specific form of debriefing that focuses on discussing death, dying, loss, and illness. Nourishment in the form of cake is provided. These sessions may allow for reflection on distressing patient events while developing a sense of community and collaboration among hospital employees.
15812349|NCT04347798|Other|Hydroxychloroquine/Chloroquine|Prospective evaluation of development of Covid-19 in inflammatory arthritis patients on biologics with anti-malarials compared to inflammatory arthritis patients on biologics without anti-malarial exposure
15812350|NCT04347785|Procedure|carotid endarterectomy|shunt
15812351|NCT04347772|Dietary Supplement|Oral Nutrition Support|Intensive Nutrition Intervention
15812352|NCT04347759|Other|Symptom Care at Home-Heart Failure|When participants call, the IVR system will ask them about each of the selected symptoms, and the patient will report symptom presence and severity numerically with the touchtone keypad. Based on symptom severity, intervention group will receive automated coaching messages. There will be a toll-free number for participants to call and a password to log into the system which will be stored on a secure and HIPPA-compliant sever. Calls can be personalized to allow the voice to greet the patient by name.
15812353|NCT04347746|Behavioral|stretching physiotherapy|"A booklet with images and a description of all movements to be performed during therapy will be offered to patients. The booklet illustrates the movements for stretching the upper limbs divided as follows: three movements for the neck, three movements for the arms and forearms and four movements for the hands.
~The therapy will be carried out twice a week at the Unopar research center, under the guidance of a physiotherapist trained in technique and supervision by a senior therapist. At the end of each movement, the individual is instructed to maintain the position for 40 seconds.
~Patients will be instructed to appear in comfortable clothes and the environment will have favorable conditions."
15812354|NCT04347746|Behavioral|Myofascial therapy|Myofascial therapy will be performed on the upper limbs, pectoral and dorsal regions with the aid of hooks (instrument assisted soft-tissue mobilization). In the supine position, the pectoral muscles will be manipulated (infracromial, external, axillary-claviculopectoral fossa), biceps brachii (short head, long and forearm insertion), round pronator, anterior forearm musculature (compartment of the radial extensor of the long carpus and brevis, finger extensor and ulnar carpal extensor). In lateral decubitus the deltoid muscle in the anterior, middle and posterior portions. In the prone position, the trapezius muscle (in its cervical, scapular and nuchal insertions), scapular levator muscle, great dorsal muscle (in its lateral insertions) and triceps brachii muscle. The hook manipulation time is two minutes of execution for each muscle mentioned above, making a total time of each section of forty minutes. There will be two weekly sessions with an interval between forty-eight hours.
15812355|NCT04347733|Drug|Triamcinolone Acetonide 40mg/mL|We aimed to examine the therapeutic efficacy of the combination of hyaluronidase and steroid injection for adhesive capsulitis and to determine whether such a combination therapy might enable the total amount of steroids to be reduced.
15812356|NCT04347733|Drug|Hyaluronidase Injection|We aimed to examine the therapeutic efficacy of the combination of hyaluronidase and steroid injection for adhesive capsulitis and to determine whether such a combination therapy might enable the total amount of steroids to be reduced.
15812357|NCT04347720|Drug|Indomethacin|Intravenous formulation
15812358|NCT04347720|Drug|Ibuprofen|Intravenous and oral formulations
15812359|NCT04347720|Drug|Acetaminophen|Intravenous and oral formulations
15812360|NCT04347707|Behavioral|BRIDGE Therapy Program|The BRIDGE Therapy Program is a novel structured form of therapy that incorporates key parenting concepts and related Dialectical Behavior Therapy (DBT) modules. The primary aim of the program is to promote self-regulation in the mother-child dyads. The program involves 20, once per week, scheduled group therapy sessions that last for 2 hours. There are two components of the program, the first is the DBT section, which will follow the DBT Skills Training Manual 2nd Edition and will target maternal mental health symptomology. The second section is the parent skill training materials, which have been designed to correspond to the 4 core DBT modules (Mindfulness, Emotion Regulation, Distress Tolerance, and Interpersonal Effectiveness) and to promote self-regulatory skill development and a positive parent-child relationship.
15812361|NCT04347681|Other|convalescent plasma from recovered COVID 19 donor|After obtaining informed consent, Eligible Patients who have severe COVID-19 and have not recovered yet will be infused with the donated convalescent plasma (10-15 ml/kg body weight of recipient)19 at least once & if possible, daily, for up to 5 sessions.
15812362|NCT04347668|Other|Virtual Reality|VR requires the user to use a multi-projected in their own room using BroomX to generate realistic images, sounds and other sensations that simulate a user's physical presence in a virtual or imaginary environment
15812363|NCT04347668|Other|Usual Care|meals, engagement in scheduled and non-scheduled programs such as exercise, and activities, groups. Residents are supported in their activities of daily living, and social engagement. Specific interventions based on resident needs are supported in a Dementia capable environment.
15812364|NCT04347655|Procedure|handgrip test|The patient will be supine for at least 5 minutes to collect baseline data before being handed a dynamometer device. The subject will then be asked to squeeze the dynamometer with maximum force for a minimum of 2 minutes while only engaging their forearm and remaining relaxed in the rest of their body. The subject will then release the dynamometer and remain supine, in recovery, for a minimum of 5 minutes.
15812365|NCT04347642|Procedure|Umbilical port placement|The port will be inserted in the midline at the level of the umbilicus.
15812366|NCT04347642|Procedure|Paraumbilical port placement|The port will be inserted 3-4cm laterally to the midline at the level of the umbilicus.
15812367|NCT04347629|Behavioral|Advance Care Planning Video Decision Aid|The video decision aid explores ACP options for medical care for end-stage renal disease (ESRD) and reviews hemodialysis, peritoneal dialysis, as well as medical management without dialysis; it also reviews cardiopulmonary resuscitation (CPR). Patients will also audio- or video-record their preferences using a tablet.
15812368|NCT04347616|Biological|UCB-NK cells|Natural killer cells generated from CD34+ hematopoietic progenitor cells derived from an allogeneic umbilical cord blood
15812369|NCT04347616|Drug|IL-2|In vivo cytokine support
15812370|NCT04347603|Procedure|TAVR|Femoral percutaneous aortic prosthesis (TAVR)
15812371|NCT04347590|Device|Unblinded - CGM (Medtronic Guardian)|Data from device will be readable and alarms on
15812372|NCT04347590|Device|Blinded - CGM (Medtronic Guardian)|Data from device will be blinded and alarms off
15812373|NCT04347577|Drug|duloxetine|open-label study
15812374|NCT04347551|Other|High velocity/low amplitude cervical spine manipulation|The participants will receive a single cervical spine rotary manipulation to the previously identified palpable cervical segmental fixation. During the performance of the manipulation, the supine participant will rest their arms at the sides of their body. Next, the index finger of the chiropractor's contact hand will be placed on the lamina of the restricted cervical segment. The chiropractor will then rotate the participant's head contralaterally until the barrier of the cervical segments volitional end range is reached. The chiropractor's other hand will be placed behind the participant's head to induce gentle neck rotation contralateral to the chiropractor's thrusting hand. The chiropractor will deliver a manual thrust, with the thrust vector directed towards the participant's opposite eye.
15812377|NCT04347525|Other|CaCBT based guided self help using Khushi aur Khatoon Manual|CaCBT based guided self help using the manual named Khushi Aur Khatoon in the intervention arm
15812378|NCT04347512|Drug|Hydroxychloroquine and azithromycin treatment arm.|"Patient allocated in this arm receive hydroxychloroquine and azithromycin for 5 days.
~For hydroxychloroquine, there is a loading dose of 800 mg per day at D1, followed by 400 mg per day D2-D5.
~For azithromycin, there is a loading dose of 500 mg per day at D1, followed by 250 mg per day D2-D5.
~Every patient receive as well antibiotic (ceftriaxone 1-2 g per day IV), and standard of care (oxygen therapy, analgesics, antipyretics, heparin, etc)."
15812379|NCT04347512|Drug|Hydroxychloroquine|"Patient allocated in this arm receive hydroxychloroquine for 5 days. For hydroxychloroquine, there is a loading dose of 800 mg per day at D1, followed by 400 mg per day D2-D5.
~Every patient receives as well antibiotic (ceftriaxone 1-2 g per day IV), and standard of care (oxygen therapy, analgesics, antipyretics, heparin, etc)."
15812380|NCT04347512|Drug|Control arm|In this arm, no experimental treatment is prescribed. Patients receive IV antibiotics and standard of care (oxygen therapy, analgesics, antipyretics, heparin, etc).
15812381|NCT04347499|Other|CaCBT based guided self help using Khushi aur Khatoon Manual|CaCBT based guided self help using the manual named Khushi Aur Khatoon in the intervention arm
15812382|NCT04347486|Drug|Sugammadex Injection 2mg/kg|Intravenous injection of 2mg/kg of sugammadex sodium on reappearance of T2
15812383|NCT04347486|Drug|Sugammadex Injection 4mg/kg|Intravenous injection of 4mg/kg of sugammadex sodium on reappearance of T2
15812384|NCT04347486|Drug|Sugammadex Injection 8mg/kg|Intravenous injection of 8mg/kg of sugammadex sodium on reappearance of T2
15812385|NCT04347486|Drug|Neuromuscular reversal agent injection|Intravenous injection of 0.02mg/kg of atropine and 0.03mg/kg of neostigmine
15812386|NCT04347473|Drug|Ilumya Injectable Product|IL-23 injection
15812388|NCT04347434|Drug|Atorvastatin 80mg|Atorvastatin is prescribed at a dose of 80 mg / day from the first 24-96 hours of AMI in addition to the standard therapy
15812389|NCT04347421|Dietary Supplement|Krill oil group|This group takes 500 mg/day Krill oil for 12 weeks.
15812390|NCT04347421|Dietary Supplement|Placebo group|This group takes 500 mg/day Placebo for 12 weeks.
15812391|NCT04347408|Diagnostic Test|Covid-19 Antibody testing (IgG and IgM)|Antibody testing for previous exposure to Covid-19
15812392|NCT04347395|Procedure|Respiratory Bundle & Prevention|The respiratory care bundle intervention comprised of: bed tilt, swallow screen, mouth wash and vaccinations. The bed tilt was a 30-degree whole bed-up positioning both day and night throughout the hospital stay and is shown in Figure 1. Swallow screen was undertaken within 48 hours of admission. Chlorhexidine mouth wash was prescribed initially four times daily. The protocol was amended to twice daily chlorhexidine mouth wash in August 2017 due to poor compliance with four times daily administration. Mouthwash administration was monitored in the intervention group only and deemed non-compliant if missed more than 3 times during the admission. Pneumococcal and influenza vaccination was offered at discharge or within 2-4 weeks post discharge, at no charge to the patient. Post discharge advice was to use pillows in bed to minimize the time the patient laid flat and to avoid lying down for an hour after meals.
15812393|NCT04347382|Drug|Honey|1gm/Kg/Day
15812394|NCT04347382|Drug|Nigella Sativa / Black Cumin|80mg/Kg/day
15812395|NCT04347382|Drug|Placebos|Empty capsule with 250ml of distilled water
15812396|NCT04347369|Other|other|clinical diagnosis
15812397|NCT04347343|Procedure|Standard Rehabilitation + Neuromuscular Electrical Stimulation and Blood Flow Restriction|"Subjects will begin a standardized protocol + COMBO (BFR and NMES) post-op day 2. Outpatient visits will be 2x/wk for weeks 0-4 and then 1x/wk for weeks 5-8. The standardized protocol will address ROM, strength, and functional activities. In addition, subjects will perform a home exercise program.
~Subjects will utilize NMES on the quadriceps in the home setting 2x/day for the first 3-4 weeks during isometric contractions at their highest tolerated intensity. Total treatment will begin at 10 minutes.
~At the end of post-op week 2, subjects will be exposed in clinic to BFR on the surgical limb increasing to 80% limb occlusion pressure over weeks 3-4 as tolerated. Initially, BFR and NMES will be performed simultaneously. BFR will then be progressed using active exercises. After completing a safety checklist, subjects will be issued a home BFR unit for use 1x/day at which time NMES will be discontinued. BFR exercise intensity will be progressed as tolerated to maintain 20-30% of 1RM."
15812398|NCT04347330|Drug|Intensive BP Control|Participants in the Intensive group have a goal of home SBP <120 mm Hg. The CRAFT BP treatment protocol is flexible in terms of the choice and doses of antihypertensive medications, but there should be preferences among the drug classes, based on CVD outcome trials results and current guidelines. Use of once-daily antihypertensive agents will be encouraged unless alternative frequency is indicated/necessary. Combination of different classes of agents are encouraged to achieve the home SBP goal. Medications will not be provided by the CRAFT study.
15812399|NCT04347330|Drug|Standard BP Control|Participants in the Standard group has a goal of home SBP <135 mmHg. The same principle of BP treatment in the Intensive BP arm will be used for the Standard BP arm. Medications will not be provided by the CRAFT study.
15812400|NCT04347317|Procedure|Low Intensity IMT|"The control group will get a supervised IMT with Threshold IMT device, once a day, 5 days a week for a maximum of 28 days or until the participant is weaned successfully. In each session the participant will do 5 sets of 6 repetitions with 2 minutes of rest between sets. The initial training load will be adjusted to 30% of the MIP and will be increased by 10% of the initial MIP weekly.
~The patient will be placed in a semi-incorporated position (head of the bed elevated 45º). The ICU physiotherapist will check before training that the cuff of the tracheal tube is correctly swollen to avoid air leaks during the training. The ICU physiotherapist will disconnect the mechanical ventilation during the IMT and will provide supplemental oxygen when required. However, between series the participant will be returned to ventilator support. Patients will be instructed to do a whole expiration and immediately inspire as forceful as possible until reaching the total lung capacity."
15812401|NCT04347317|Procedure|High Intensity IMT|"The experimental group will get a supervised IMT with Threshold IMT device, once a day, 5 days a week for a maximum of 28 days or until the participant is weaned successfully. In each session the participant will do 5 sets of 6 repetitions with 2 minutes of rest between sets. The initial training load will be adjusted to 60% of the MIP and will be increased by 10% of the initial MIP weekly.
~The patient will be placed in a semi-incorporated position (head of the bed elevated 45º). The ICU physiotherapist will check before training that the cuff of the tracheal tube is correctly swollen to avoid air leaks during the training. The ICU physiotherapist will disconnect the mechanical ventilation during the IMT and will provide supplemental oxygen when required. However, between series the participant will be returned to ventilator support. Patients will be instructed to do a whole expiration and immediately inspire as forceful as possible until reaching the total lung capacity."
15812402|NCT04347304|Dietary Supplement|Dark chocolate (20 grams) per day providing 508 mg of polyphenols|subjects will be given 21 grams of dark chocolate providing 289 mg of polyphenols per day for 12 weeks.
15812403|NCT04347304|Dietary Supplement|white chocolate (20 grams) with no polyphenols|subjects will be given 21 grams of white chocolate (0 mg polyohenols) per day for 12 weeks
15812404|NCT04347291|Behavioral|FAMS 2.0|FAMS components include monthly phone coaching following a semi-structured protocol plus daily automated text message support to the patient participant and less frequent automated text messages to their support person, if enrolled.
15812405|NCT04347291|Behavioral|Print Materials|Quality print materials about diabetes management provided upon enrollment and in quarterly study newsletters.
15812406|NCT04347278|Drug|Patients with the treatment agains COVID19|"Data will be collected from patients who receive any of the treatments included in the Technical Document. Manejo clínico del COVID-19: tratamiento médico of the Ministry of Health, and Tratamientos disponibles para el manejo de la infección respiratoria por SARS-CoV-2 of the AEMPS, either as antivirals or as treatment of the inflammatory process in patients with SARS, or others as they arise."
15812407|NCT04347265|Other|NMP|Participants received the percutaneous electrical stimulation intervention. Specifically, this consisted of the application of a square wave biphasic electrical current, with 3 Hz frequency and a 250µs pulse width, at the maximal tolerable intensity, to cause an tolerable muscle contraction. The application was 10 stimulations of 10 seconds, with 10 seconds at rest between stimulations. A trained physiotherapist performed the PNM intervention.
15812408|NCT04347252|Drug|Glucagon|Intravenous infusion of glucagon at fasting or elevated glycemia. Blockade of the GLP-1 receptor during hyperglycemia with and without glucagon.
15812409|NCT04347239|Drug|Placebos|Placebos
15812410|NCT04347239|Drug|Leronlimab (700mg)|Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
15812411|NCT04347226|Drug|BMS-986253|BMS-986253 2400mg IV at 0 and 2 weeks (if patient is still hospitalized) and then 4 weeks (only if still hospitalized with continued severe respiratory disease).
15812412|NCT04347213|Behavioral|Regular lifestyle in different circumstances|Participants' lifestyle will be followed over the years.
15812413|NCT04347200|Drug|Antiplatelet Drug|single or dual antiplatelets, triple antithrombotic theraphy
15812414|NCT04347187|Drug|Anticoagulants|oral anticoagulants, dual or triple antithrombotic theraphy
15812415|NCT04347174|Drug|Suspension of heat killed (autoclaved) Mycobacterium w|Patients will be randomized to receive either Mycobacterium w in combination with standard care as per hospital practice or standard care alone in COVID-19 as per hospital practice.
15812416|NCT04347174|Drug|Placebo|All patients will continue to receive standard therapy as per hospital practice till considered requisite by the treating physician
15812417|NCT04347161|Device|Conversational Agent/Chatbot|Via text messages, the bidirectional, conversation agent provides specific dosing instructions and motivational reminders to promote oral targeted therapy adherence and symptom management. Patients can report symptoms at any time via text message and are also prompted to report symptoms and medication adherence at periodic intervals. Reported symptoms are monitored and managed algorithmically according severity. High-grade symptoms are triaged directly to the patients' cancer care team. Patients in the intervention arm will use MEMS caps to enable capture of the primary outcome and asked to complete longitudinal surveys.
15812418|NCT04347161|Other|Usual Care|Patients in the control arm will receive usual care, which includes receiving information about dosing and self-administration of oral therapy, and anticipatory guidance for patients regarding management of side effects. Patients in the control arm will use MEMS caps to enable capture of the primary outcome and asked to complete longitudinal surveys.
15812419|NCT04347148|Procedure|SNAGs Treatment|a sustained passive accessory movement (glide), i.e. SNAGs, will be applied by the physiotherapist while the participant will be asked to move actively as allowed by his/her physiological range in the direction producing his symptoms.
15812420|NCT04347148|Procedure|Sham Laser Treatment|A Laser YAG 3 Chronic (Winform Medical Engineering s.r.l., San Donà di Piave (VE), Italy), will be detuned and applied in the region of cervical spine in order to have a sham treatment
15812421|NCT04347135|Drug|F-18 FES|F-18 FES PET/MRI for detection of endometriosis.
15812422|NCT04347122|Drug|Tranexamic Acid (TXA)|Intervention groups will receive TXA 1g TXA IVPB 10 minutes prior to incision and a second dose of 1g IVPB at the time of closure.
15812423|NCT04347109|Diagnostic Test|Non invasive epicardial mapping|Non invasive mapping using Cardio Insight system is performed in all included patients.
15812424|NCT04347096|Behavioral|mHealth Intervention|"The mHealth Intervention will provide sedentary workers with evidence-based information on diet, physical activity and sedentary behavior, and tailored feedback on their responses to daily records. Key features of this intervention will include individualized feedback and multimedia presentation in the form of web app. The intervention group will also receive a reliable device for wireless physical activity tracking for monitoring step counts.
~The web app will consist of seven major components: (1) daily healthy eating goals and records; (2) daily physical activity goals and records; (3) daily stand-up goals and records; (4) advice and reminder; (5) educational and motivational tools; (6) personal and team health ranking; and (7) online social network. In addition, the intervention will be enhanced with follow-up booster coaching calls bi-monthly at 2, 4, 6, 8 months after the 12-week intervention."
15812425|NCT04347096|Behavioral|Control Intervention|The control intervention group will receive educational tools, which will provide knowledge on benefits of physical activity and healthy eating, health risks of sitting and unhealthy diets, and recommendations on physical activity and a balanced healthy diet for good health.
15812426|NCT04347083|Diagnostic Test|Electrodiagnostic test|Muscle spindle- based reflex latency will be measured
15812427|NCT04347070|Other|Phsyiotherapy|To observe if patients with COVID-19 benefice of physiothersapy, which kind and how many time
15812428|NCT04347057|Other|Bed bathing with 2% CHG solution|Patients were bathed from the neck down, avoiding contact with face, mucous membranes and wounds by wiping with CHG solution for each period. The patient's skin bathed in the order of clean area to dirty area. Additionally, if patients in both arms became soiled after the daily baths, contaminated body areas were wiped using water and disposable washcloths. Patients were assessed daily for localised or body-wide skin reactions.
15812429|NCT04347057|Other|Bed bathing with soap and water|Patients were bathed from the neck down, avoiding contact with face, mucous membranes and wounds by wiping with soap and water. The patient's skin bathed in the order of clean area to dirty area. Additionally, if patients in both arms became soiled after the daily baths, contaminated body areas were wiped using water and disposable washcloths. Patients were assessed daily for localised or body-wide skin reactions. During control period, patients were washed with soap and then rinsed with water, and dried with disposable towels
15812430|NCT04347044|Other|Pulmonary Rehabilitation|Exercise training+ Optimal medication and clinical follow-up
15812431|NCT04347044|Other|Standart care|Optimal medication and clinical follow-up
15812432|NCT04347031|Drug|Mefloquine|"1st day: 750 mg of mefloquine per day, inside, in tablets of 250 mg 3 times a day - 1 tablet every 8 hours.
~Day 2: 500 mg of mefloquine, inside, in tablets of 250 mg 2 times a day - 1 tablet every 12 hours.
~3rd - 7th day: 250 mg of mefloquine, inside, in tablets of 250 mg 1 time a day at the same time."
15812433|NCT04347031|Drug|Hydroxychloroquine|"st day: 800 mg of hydroxychloroquine per day, inside, in 200 mg tablets, 2 tablets 2 times a day;
~nd - 7th day: 400 mg of hydroxychloroquine per day, inside, in tablets of 200 mg, 1 tablet 2 times a day."
15812434|NCT04347031|Combination Product|Mefloquine + azithromycin + / - tocilizumab|"1st day: 750 mg of mefloquine per day, inside, in tablets of 250 mg 3 times a day - 1 tablet every 8 hours.
~Day 2: 500 mg of mefloquine, inside, in tablets of 250 mg 2 times a day - 1 tablet every 12 hours.
~3rd - 7th day: 250 mg of mefloquine, inside, in tablets of 250 mg 1 time a day at the same time."
15812462|NCT04346862|Drug|Acetyl-L-carnitine hydrochloride 500mg|The participants will receive treatment of Acetyl-L-carnitine hydrochloride 500mg, orally, 3 times a day for 24weeks
15812435|NCT04347031|Combination Product|Hydroxychloroquine + azithromycin + / - tocilizumab|"st day: 800 mg of hydroxychloroquine per day, inside, in 200 mg tablets, 2 tablets 2 times a day;
~nd - 7th day: 400 mg of hydroxychloroquine per day, inside, in tablets of 200 mg, 1 tablet 2 times a day."
15812436|NCT04347018|Device|BRIUS|This is a device that is designed based on movements planned virtually on a computer program. Then all the planned movements are embedded into the wire causing the wire to have the necessary bends to move every tooth into its pre-planned final position. This causes the pre-activated wire to consistently express a low force over a long period of time onto all the teeth. This allows the teeth to move into the final position and treatment progresses towards completion
15812437|NCT04347005|Drug|Cohort 1: AR882|Single dose of AR882 or matching placebo
15812438|NCT04347005|Drug|Cohort 2: AR882|Single dose of AR882 or matching placebo
15812439|NCT04347005|Drug|Cohort 3: AR882|Single dose of AR882 or matching placebo
15812440|NCT04347005|Drug|Cohort 4: AR882|Single dose of AR882 or matching placebo
15812441|NCT04347005|Drug|Cohort 5: AR882|Single dose of AR882 or matching placebo
15812442|NCT04347005|Drug|Cohort 6: AR882 Food Effect|Single dose of AR882 or matching placebo in a fed state
15812443|NCT04347005|Drug|Cohort 7: AR882 Solid Oral Formulation|Single dose of AR882 or matching placebo
15812444|NCT04347005|Drug|Cohort 8: AR882 in combination with allopurinol|Single dose of allopurinol alone and a single dose of AR882 in combination with a single dose of allopurinol
15812445|NCT04347005|Drug|Cohort 9: AR882 in combination with febuxostat|Single dose of febuxostat alone and a single dose of AR882 in combination with a single dose of febuxostat
15812446|NCT04346992|Other|no intervention|no intervention
15812447|NCT04346979|Other|Telerehabilitation-Based|25 volunteers postmenopausal women who are at home during the social isolation process due to the coronavirus outbreak will be included in this group. Online yoga and mindfulness protocol was created for individuals who will participate in the study. Each training protocol was planned as 30 minutes for 3 days a week for 6 weeks. It was planned to start the protocol with warm-up exercises and finish with cooling exercises. Respiratory exercise was added to the training protocol. Individuals were asked to participate in the study via telerehabilitation system and aimed to do their exercises with a physiotherapist.
15812448|NCT04346979|Other|Video-Based|25 volunteers postmenopausal women who are at home during the social isolation process due to the coronavirus outbreak will be included in this group. Online yoga and mindfulness protocol was created for individuals who will participate in the study. Each training protocol was planned as 30 minutes for 3 days a week for 6 weeks. It was planned to start the protocol with warm-up exercises and finish with cooling exercises. The respiratory exercise was added to the training protocol. Video recordings containing only yoga and mindfulness training were sent to individuals. The participants were supervised by the researcher.
15812449|NCT04346966|Other|Study Group|Video Based Exercises 64 young adults aged 18-40, who are socially isolated due to coronavirus, will be included in this group. A video-based exercise protocol was created for individuals to participate in the study. Each exercise session is planned as 30 minutes 7 days a week for 6 weeks. The protocol was planned to start with warm-up exercises and end with cooling exercises. The exercise protocol has also been determined as a combination of aerobic exercises, strengthening and posture exercises. Individuals will be classified at 4 levels according to their physical activity levels and will be shared with volunteers according to their level of exercise. Volunteers will be evaluated before and after 6 weeks of exercise.
15812450|NCT04346953|Behavioral|Video based exercise|Individuals (n = 64) to be included in the study group will be grouped according to the levels of physical activity (low, medium, high level) determined by the International Physical Activity Questionnaire. An exercise program will be created for each group based on physical activity levels and videos of these exercise programs will be prepared. The videos will be scheduled for 20 minutes. Individuals will be asked to apply for these programs with video for 20 minutes every day for 6 weeks. Exercise programs will start with pulmonary exercises and warm-up exercises to prepare for exercise. The exercise program will end with cool down exercises. The exercise protocol will be determined as a combination of aerobic and strengthening exercises.
15812451|NCT04346940|Other|Telerehabilitation|15 volunteers aged 65 and over will be included in this group. An online exercise program has been created for individuals who will participate in the study. It is planned that this program will continue for 3 days a week, 6 weeks, and the duration of exercise will reach 45 minutes in the last week due to the increase in the number of repetitions about 30 minutes at the beginning. The treatment sessions will start with warm-up exercises, complete with posture exercises, joint range of motion exercises, stretching exercises, and cool-down exercises in the main program.
15812452|NCT04346940|Other|Exercise brochure|The same exercises will be given to the control group as a brochure and they will be asked to do it for 6 weeks.
15812453|NCT04346927|Other|Telerehabilitation|15 volunteers diagnosed with coronavirus will be included in experimental group. An online exercise program has been created for individuals who will participate in the study. This program is planned to continue 3-4 days a week, in a 30-minute session and for 6 weeks. Treatment sessions will include breathing exercises, posture exercises, peripheral muscle exercises and light aerobic exercises. Individuals were asked to participate in the research via telerehabilitation connection system and were told that they would do their exercises with a physiotherapist.
15812454|NCT04346927|Other|exercise brochure|15 volunteers diagnosed with coronavirus will be included in control group.The same exercises will be given to the control group as a brochure and they will be asked to do it for 6 weeks.
15812455|NCT04346914|Biological|recombinant anti-PD-L1 monoclonal antibody injection combined with carboplatin and etoposide|ZKAB001 ,5 mg/kg, d1，q3w； carboplatin，5 AUC，d1，q3w； etoposide，100mg/m2，d1~3，q3w
15812456|NCT04346901|Drug|Thiamazol|All new hyperthyroid with melasma patients were recruited and their mMASI were calculated All subjects were given thiamazole by Internist based on their clinical hyperthyroidism After 3 months of taking hyperthyroid drugs (thiamazole), mMASI were recalculated and compared
15812457|NCT04346888|Drug|HBM9161 Injection (680mg and 340 mg)|HBM9161 Injection (680mg and 340mg)
15812458|NCT04346888|Drug|Placebos|Placebo, HBM9161 Injection (340mg)
15812459|NCT04346888|Drug|HBM9161 Injection (340 mg)|HBM9161 Injection (340 mg)
15812460|NCT04346875|Procedure|Regularly changing of dressing|Conventional dressing
15812461|NCT04346875|Procedure|No application|No dressing change
15812463|NCT04346862|Drug|Placebo|The participants will receive treatment of placebo of Acetyl-L-carnitine hydrochloride 500mg, orally, 3 times a day for 24weeks
15812464|NCT04346849|Procedure|Pulpotomy|Cutting the coronal portion of the pulp and application of a calcium silicate based material followed by restoration
15812465|NCT04346836|Behavioral|Low-intensity, general-fitness exercises|"24 session of low-intensity, general-fitness exercises (12 weeks, twice a week)
~A single session of exercise lasted 40 minutes and consisted of 42 low-intensity, general-fitness exercises. Perception of effort was monitored using the Borg 6-20 rating the perceived exertion (RPE).
~Thirty-three exercises were done sitting down, seven standing, and two in the hand-and-knees position. The exercises were classified as either aerobic, musculo-articular, or stabilising. The aerobic portion served as a general warm-up for the subsequent exercises, and the musculo-articular section focused on strengthening muscles and enhancing the mobility of joints in the upper limbs, the lower limbs and the torso. Stabilising exercises were designed to improve the stability of the body and to augment spatio-visual coordination."
15812466|NCT04346836|Behavioral|Psychoeducation|A psychoeducation provided by psychotherapist. Twenty minutes of psychoeducation, which contained mini lectures about mental well-being, psychohygiene and healthy dietary habits.
15812467|NCT04346823|Drug|Sevoflurane|"Each participant started by preoxygenation of 100% oxygen for 3minutes. Then, parturients breath 1% of sevoflurane in a mixture of oxygen and air (FIO2 0.5) by tight face mask with a gas flow of 6 L/min.
~Thirty seconds after stating inhalation sedation, the obstetrician will be asked to start the procedure.The duration of ECV in addition to the level of difficulty estimated by obstetricians will be recorded. Usually, the duration of ECV does not exceed 10 minutes.
~The intervention will be stopped if the woman reported severe pain, if version could not be achieved readily, or if prolonged fetal bradycardia, uterine bleeding or placental abruption occurred.
~Parturient will be kept in Post Anesthesia Care Unit (PACU) for 45minutes. CTG will be monitored during PACU stay."
15812468|NCT04346810|Other|Patient management suffering of coronavirus infection|Welle-being and stress of the caregivers
15812469|NCT04346797|Drug|Eculizumab|"Intravenous administration as follows:
~Induction dosage regimen at 1200 mg on Days 1, 4, 8 then 1200 mg or 900 mg on Day 12 depending on the monitoring of Eculizumab Plasma Level and CH5O and sC5B9 and maintenance doses of 900 mg on Days 15, 18 and 22"
15812470|NCT04346784|Behavioral|maintaining positive working memory training|Participants complete 10 sessions of maintaining positive working memory training during a two-week period. Each session consists of 15 blocks.
15812471|NCT04346784|Behavioral|repressing negative working memory training|Participants complete 10 sessions of repressing negative working memory training during a two-week period. Each session consists of 15 blocks.
15812472|NCT04346784|Behavioral|Positive ABMT|Participants complete 8 sessions of attention bias modification training (ABMT) during a two-week period. Each session consists of 218 trials, and the time to complete a training session is 12 minutes.
15812473|NCT04346784|Behavioral|Positive placebo ABMT|Participants complete 8 sessions of attention bias modification training (ABMT) during a two-week period. Each session consists of 218 trials, and the time to complete a training session is 12 minutes
15812474|NCT04346771|Behavioral|Working memory training|Participants complete 10 sessions of maintaining positive working memory training during a two-week period. Each session consists of 15 blocks.
15812475|NCT04346771|Behavioral|Positive ABMT|Participants complete 8 sessions of attention bias modification training (ABMT) during a two-week period. Each session consists of 218 trials, and the time to complete a training session is 12 minutes.
15812476|NCT04346758|Procedure|lumbar plexus block|Patients undergoing orthopedic procedures of the lower extremeties are going to be studied. A modified Shamrock approach of the lumbar plexus is going to be used for postoperative analgesia, using an ultrasound-guided technique combined to a nerve stimulatior. The technique is going to be assessed as for accuracy, and safety.
15812477|NCT04346745|Behavioral|Peer Mentoring Program|The Peer Mentoring Program (PMP) is a 3-month intervention to provide one-on-one mentoring support via phone calls to reduce the stress of Chinese dementia caregivers. The PMP will address the following topics: cultural beliefs about dementia and family caregiving, culturally effective coping strategies, and culturally appropriate social support.
15812478|NCT04346732|Other|Vapocoolant spray|Vapocoolant spray
15812479|NCT04346719|Device|10 kHz stimulation (Myomed 932, Enraf-Nonius)|"A charge-balanced, symmetric, biphasic sinusoidal current without modulation will be delivered at a frequency of 10 kHz. The stimulation intensity will be defined as that sufficient to produce a strong but comfortable sensation, just below motor threshold, over the median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft,Netherlands)"
15812480|NCT04346719|Device|20 kHz stimulation (Myomed 932, Enraf-Nonius)|"A charge-balanced, symmetric, biphasic sinusoidal current without modulation will be delivered at a frequency of 20 kHz. The stimulation intensity will be defined as that sufficient to produce a strong but comfortable sensation, just below motor threshold, over the median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft,Netherlands)"
15812481|NCT04346719|Device|Sham stimulation (Myomed 932, Enraf-Nonius)|Sham stimulation will be delivered at a frequency of 10 kHz only during the first 30 seconds.
15812482|NCT04346706|Device|Extraction and Implant insertion (test)|"The surgical procedure was conducted under local anesthesia. Intrasulcular incisions were performed around the mesial and distal tooth to the implant recipient site. Buccal and palatal mucoperiosteal flaps were elevated. Tooth extractions were carried out atraumatically using periotomes. Implant site preparation was completed in compliance with the general surgical principles and protocols defined by the manufacturer and screw-shaped implants (UFII, DIO™) were inserted at no less than 35 Ncm. Final insertion torque (IT) was measured and recorded using a manual hand wrench (DIO™). Resonance frequency analysis (RFA) was performed using an Osstell device (Sävedalen, Sweden). For each implant, three Implant Stability Quotient (ISQ) readings were recorded by the same operator to calculate the mean ISQ, at implant placement (T0) and 3 months after implant insertion (T3) prior to final abutment torque and crown cementation.
~Absorbable interrupted 4.0 sutures were used for flap closure."
15812502|NCT04346589|Biological|Anti-coronavirus antibodies (immunoglobulins)obtained with DFPP from convalescent patients|Antibodies obtained from consenting convalescent donors will be administered to ten consecutive patients who fulfill the inclusion criteria . Convalescent antibodies will be obtained with one DFPP procedure from consenting donors and infused in one critically ill, ventilated patient with COVID 19 pneumonia.
15812483|NCT04346706|Device|Implant insertion (control)|"The surgical procedure was conducted under local anesthesia. Intrasulcular incisions were performed around the mesial and distal tooth to the implant recipient site. Buccal and palatal mucoperiosteal flaps were elevated, the implant site preparation was completed in compliance with the general surgical principles and protocols defined by the manufacturer and screw-shaped implants (UFII, DIO™) were inserted at no less than 35 Ncm. Final insertion torque (IT) was measured and recorded using a manual hand wrench (DIO™). Resonance frequency analysis (RFA) was performed using an Osstell device (Sävedalen, Sweden). For each implant, three Implant Stability Quotient (ISQ) readings were recorded by the same operator to calculate the mean ISQ. This was done at implant placement (T0) and 3 months after implant insertion (T3) prior to final abutment torque and crown cementation.
~Absorbable interrupted 4.0 sutures were used for flap closure."
15812484|NCT04346693|Procedure|Standard therapy recommended by the Ministry of Health of the Russian Federation.|"Hydroxychloroquine + azithromycin + / - tocilizumab. Hydroxychloroquine intake is conducted according to the following schedule: 400 mg twice per day for 1-2 days of the treatment and 200 mg twice per day during six days of the treatment course.
~For the tocilizumab, 400 mg intravenously drip slowly (for at least 1 hour), with insufficient effect, administration is repeated the after 12 hours. Simultaneously no more than 800 mg of tocilizumab could be administered.
~For the azithromycin admission 500mg on day 1 is prescribed followed by 250mg per day, the next four days"
15812485|NCT04346693|Procedure|Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin intramuscular injection|"Hydroxychloroquine + azithromycin + / - tocilizumab. Hydroxychloroquine intake is conducted according to the following schedule: 400 mg twice per day for 1-2 days of the treatment and 200 mg twice per day during six days of the treatment course.
~For the tocilizumab, 400 mg intravenously drip slowly (for at least 1 hour), with insufficient effect, administration is repeated the after 12 hours. Simultaneously no more than 800 mg of tocilizumab could be administered.
~For the azithromycin admission 500mg on day 1 is prescribed followed by 250mg per day, the next four days.
~Additional intramuscular injection of the drug Dalargin (solution for intravenous and intramuscular doses) under dosage of 1 mg daily once per day for 10 days"
15812486|NCT04346693|Procedure|Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin inhalation|"Hydroxychloroquine + azithromycin + / - tocilizumab. Hydroxychloroquine intake is conducted according to the following schedule: 400 mg twice per day for 1-2 days of the treatment and 200 mg twice per day during six days of the treatment course.
~For the tocilizumab, 400 mg intravenously drip slowly (for at least 1 hour), with insufficient effect, administration is repeated the after 12 hours. Simultaneously no more than 800 mg of tocilizumab could be administered.
~For the azithromycin admission 500mg on day 1 is prescribed followed by 250mg per day, the next four days.
~Additional inhalation of the drug Leitragin, at a dose of 10 mg daily once per day until the symptoms of pulmonary complications will be ceased."
15812487|NCT04346693|Procedure|Standard therapy recommended by the Ministry of Health of the Russian Federation and Leitragin intramuscular injection combined with Leitragin inhalation|"Hydroxychloroquine + azithromycin + / - tocilizumab. Hydroxychloroquine intake is conducted according to the following schedule: 400 mg twice per day for 1-2 days of the treatment and 200 mg twice per day during six days of the treatment course.
~For the tocilizumab, 400 mg intravenously drip slowly (for at least 1 hour), with insufficient effect, administration is repeated the after 12 hours. Simultaneously no more than 800 mg of tocilizumab could be administered.
~For the azithromycin admission 500mg on day 1 is prescribed followed by 250mg per day, the next four days.
~Additional inhalation of the drug Leitragin, at a dose of 10 mg daily once per day until the symptoms of pulmonary complications will be ceased.
~Additional intramuscular injection of the drug Dalargin (solution for intravenous and intramuscular doses) under dosage of 1 mg daily once per day for 10 days"
15812488|NCT04346680|Procedure|ADSC administration|The treated nerve will be identified and released. Scar tissue will be removed, and nerve fibers will be exposed. Prepared solutions of ADSC will be administered via microinjection with a 30-G needle along the released nerve fascicles, above and below the reconstructed area and around the adjacent tissue, which stayed in contact with the nerves.
15812489|NCT04346667|Drug|Hydroxychloroquine Sulfate Regular dose|Hydroxychloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2
15812490|NCT04346667|Drug|Hydroxychloroquine Sulfate Loading Dose|Hydroxychloroquine administered as a loading dose only
15812491|NCT04346667|Drug|Chloroquine|Chloroquine administered based off of in-vitro pharmacokinetics study of optimal dosage for efficacy against SARS-CoV-2
15812492|NCT04346667|Drug|Placebo|Standard of Care plus placebo
15812493|NCT04346654|Drug|Eltrombopag|Eltrombopag is for oral use and comes in 25, 50 and 75 mg tablets. Prescribed dose is taken once daily.
15812494|NCT04346654|Drug|Dexamethasone|Dexamethasone is for oral use and comes in 8 mg tablets. Prescribed dose is taken once daily.
15812495|NCT04346641|Diagnostic Test|Facial Measurements and Tooth Size and Pulp Volume|Radiographic images of patients who have been indicated for cone-beam computed tomography for the upper jaw for various reasons (such as impacted teeth, sinusitis, skeletal anomalies) will be reviewed retrospectively. Facial measurements (lower face height, midface height, inter-zygomatic distance, inter-pupillary distance, inter alar distance, epicanthus distance, the distance between commissures) of the patients who received cone beam computed tomography will be measured in the clinic. Mesiodistal distance, buccal palatal distance, root length, pulp volume of maxillary sixth tooth will be measured using cone beam computed tomography. The data obtained will be compared.
15812496|NCT04346628|Drug|Favipiravir|Favipiravir administered orally, 1800 mg on the first dose (day 1) followed by 800 mg twice daily for the next 9 days (days 2-10).
15812497|NCT04346628|Drug|Placebo|Placebo to match favipiravir administered orally through day 10.
15812498|NCT04346628|Other|Standard of care treatment|Standard of care treatment for COVID-19 infection
15812499|NCT04346615|Drug|Zavegepant (BHV-3500)|10 mg intranasal (IN) for 14 days
15812500|NCT04346615|Drug|Placebo|Placebo Q8h for 14 days
15812501|NCT04346602|Other|all treatment about COVID-2019|All patients with COVID-2019 would receive treatment provided by the government and should comply with relevant laws and regulations.
15812538|NCT04346277|Biological|IC14, a monoclonal antibody against CD14|IC14 is a recombinant chimeric anti-human monoclonal antibody directed against human CD14. It recognizes both membrane-bound CD14 and soluble CD14.
15814480|NCT04330144|Other|Others(No intervention)|No treatment. Close monitoring and quarantine.
15812503|NCT04346576|Dietary Supplement|Probiotics prevent health problems in children|A controlled field trial was conducted with 1,036 children (3-5 years old) in Thanh Hoa province in Vietnam. The probiotic group (n=518) consumed fermented milk 65 mL/day containing 108 CFU/mL of LcS for the 12-week intervention period, whereas the control group (n=493) were not given any. The incidence of constipation, diarrhea, ARI, and anthropometry in children was determined at baseline, after 4, 8, and 12-week intervention and after the 4-week follow-up period.
15812504|NCT04346563|Other|Kinesio tape, functional correction technique|According to Kinesio Taping, functional correction technique could use for correcting shoulder, scapular alignment and decrease pain.
15812505|NCT04346563|Other|Elastic band strengthening shoulder exercise|"The exercise in which both groups will receive Introduction of exercise with rubber bands (Elastic band) It is a home exercise (Home base exercise program) for patients to do with appropriate resistance. Which can be done at least 10 times and not more than 20 times continuously,will be asked to do all 3 positions.
~1) Shoulder external rotation in shoulder abduction 90 degrees 2) Shoulder horizontal abduction in shoulder abduction 90 degrees 3) Seated bend row, which will be done 15 times, each hold for 10 seconds, do 3 sets, each set rest 2 minutes, 2 times a day ( Morning-evening) consecutively for 1 week"
15812506|NCT04346550|Other|Suction drain|Post operatively, in both arms including drain group and no drain group, parameters of pain was assessed by visual analog scale (VAS) from 0 (no pain) to 10 (worst pain), assessed at 1st postoperative day by the duty doctor or the nurse. VAS > 3 was considered as post surgical pain. The total number of hospital stay was noted from the day of operation till the day of discharge and discharge criteria was taken as a patient having pain as per VAS<3, no fever and tolerating oral intake
15812507|NCT04346537|Device|INGEVITY+™ Pace/Sense Lead|The INGEVITY+ lead is indicated for chronic pacing and sensing in the right atrium and/or right ventricle when used with a compatible pulse generator.
15812508|NCT04346524|Other|sampling of microbiome|women will sample from vagina, feces, and saliva during pregnancy
15812509|NCT04346511|Other|Acupuncture|Patients will have six, 0.25*40mm sterilized stainless steel acupuncture needles (Dongbang Acupuncture, Inc., Seoul, South Korea) inserted into six acupoints (sites ST36, LV3, KI2, bilaterally) on their lower legs. After insertion, the needles will be stimulated at 2-4Hz, 10s at each point (1min total), immediately after insertion, 5min, 10min, 15min and just before removal.
15812510|NCT04346498|Other|Chest-to-back|
15812511|NCT04346485|Procedure|SP TFL RIRS with 145 mcm fiber|retrograde intrarenal surgery
15812512|NCT04346485|Procedure|SP TFL RIRS with 200 mcm fiber|retrograde intrarenal surgery
15812513|NCT04346485|Procedure|Ho:YAG RIRS with 200 mcm fiber|retrograde intrarenal surgery
15812514|NCT04346472|Other|Repeated Measurements of the relative regional cerebral blood volume|Repeated Measurements of the relative regional cerebral blood volume variation through an every 6 monts Magnetic Resonance Imaging use.
15812515|NCT04346459|Procedure|"Tracheal intubation through Fastrach - Group A"|"Insertion of the intubating laryngeal mask Fastrach and blind tracheal intubation through the device"
15812516|NCT04346459|Procedure|"Tracheal intubation through I-gel - Group B"|"Insertion of the supraglottic airway device i-gel and tracheal intubation through the device guided by a fiberoptic bronchoscope"
15812517|NCT04346459|Procedure|"Tracheal intubation through Protector - Group C"|"Insertion of the laryngeal mask Protector and tracheal intubation through the device guided by a fiberoptic bronchoscope"
15812518|NCT04346446|Drug|Convalescent Plasma Transfusion|Convalescent Plasma Transfusion
15812519|NCT04346446|Other|Supportive Care|Supportive Care
15812520|NCT04346446|Drug|Random Donor Plasma|Random Donor Plasma will be transfuse from 200 to 600 mL according to the patient requirement
15812521|NCT04346433|Behavioral|Restricted Sleep|During the restricted sleep condition adolescents will sleep 4 hours ±1 hour (0100-0500). This condition will last 1 night.
15812522|NCT04346433|Behavioral|Adequate Sleep|During the adequate sleep condition adolescents will sleep 9 hours ±1 hour (2100- 0800). This condition will last 1 night.
15812523|NCT04346420|Other|Standard interface|The standard interface for administering oxygen (nasal cannula or oxygen mask) is worn by the patient. Oxygen output is adapted to reach a SpO2 target of 94%.
15812524|NCT04346420|Device|Double-Trunk Mask|The standard nasal cannula interface accompanied with the DTM is worn by the patient. Oxygen output is adapted to reach a SpO2 target of 94%.
15812525|NCT04346407|Drug|Dronabinol 2.5mg Cap|2.5mg of oral Dronabinol daily starting with pre-op cocktail and continued twice daily for three days after surgery
15812526|NCT04346407|Drug|Placebo|Placebo capsule daily starting with pre-op cocktail and continued twice daily for three days after surgery
15812527|NCT04346394|Drug|Yohimbine HCl|Yohimbine hydrochloride will be used to manipulate the noradrenergic system during some of the assessments. By measuring the amounts of hormones the body produces before and after yohimbine hydrochloride administration, researchers can assess how well the noradrenergic system is functioning
15812528|NCT04346381|Drug|Camrelizumab|Intravenous (IV) camrelizumab on Day 1 of each cycle
15812529|NCT04346381|Drug|Famitinib|famitinib po qd
15812530|NCT04346368|Biological|BM-MSCs|Participants will receive conventional treatment plus BM-MSCs(1*10E6 /kg body weight intravenously at Day 1).
15812531|NCT04346368|Biological|Placebo|Placebo
15812532|NCT04346355|Drug|Tocilizumab|In case of aggravation of COVID-19 pneumonia, according to protocol criteria, participants will receive 8 mg/kg IV up to a maximum of 800 mg with repetition of the same dosage after 12 hours
15812533|NCT04346329|Drug|Hydroxychloroquine|Treated group
15812534|NCT04346329|Drug|Placebo oral tablet|Placebo Group
15812535|NCT04346316|Drug|SHR0302|Oral tablets taken once daily (QD)
15812536|NCT04346303|Other|Short-term Interactive Video Games|"Collect basic information through a structured questionnaire, which includes basic information, disease status, life style and other related information.
~Three data collections were performed, namely the baseline period (T0) and the pre-program (T1) two weeks later. Three weeks of intervention activities were provided twice a week, followed by a post-test ( post-program, T2).
~After a total of six times mentioned above, each 60 minutes of interactive video game intervention, the patient completed the activity feedback form, reflecting the feelings and feedback of participating in the activity."
15812537|NCT04346290|Drug|Dexmedetomidine|Initial infusion dose of dexmedetomidine is 0.4 mcg/kg/min, maintenance infusion dose is 0.1-0.7 mcg/kg/min
15814548|NCT04329494|Drug|Doxorubicin|Given via PIPAC
15812539|NCT04346264|Diagnostic Test|NO intervention planned due to the observational study design only a diagnostic testing|Only a diagnostic test (serum blood and antibody measurement) is planned
15812540|NCT04346238|Other|Reuse of existing data from patients' medical records|Reuse of existing data from patients' medical records
15812541|NCT04346225|Drug|Hyperpolarized C13|Given by intravenous injection. When receiving two HP 13C pyruvate injections, the injections will be separated by a period of 15-60 minutes
15812542|NCT04346225|Procedure|Magnetic Resonance Imaging (MRI)|Magnetic resonance imaging (MRI) is a medical imaging technique that uses a magnetic field and computer-generated radio waves to create detailed images of the organs and tissues in your body
15812543|NCT04346212|Diagnostic Test|Swallowing evaluation with the EAT-10 and the volume-viscosity swallowing test (V-VST)|We will assess dysphagia, nutritional status and needs of compensatory treatment (fluid and nutritional adaptation) in patients with COVID-19 disease. We will also collect clinical data, information about swallowing and nutritional status and needs through the electronical medical history of the patients and by telephone call at 3 and 6 months follow-up, as well as clinical complications.
15812544|NCT04346199|Drug|Acalabrutinib|Acalabrutinib- administered orally
15812545|NCT04346186|Diagnostic Test|IgM and IgG diagnostic kits to SARS-CoV-2|Diagnostic kits for IgM/IgG antibodies to SARS-CoV-2
15812546|NCT04346186|Diagnostic Test|Elisa-test for IgM and IgG to SARS-CoV-2|Elisa-test for IgM and IgG to SARS-CoV-2
15812547|NCT04346173|Procedure|furlow z plasty with buccinator myomucosal flap|using furlow palatoplasty technique accompanied with addition of buccinator myomucosal flap for closure of primary unilateral cleft palate
15812548|NCT04346160|Diagnostic Test|Schirmer Test I|Collection of tear fluid
15812549|NCT04346147|Drug|Imatinib tablets|Imatinib 400 mg QD oral
15812550|NCT04346147|Drug|Baricitinib Oral Tablet|Baricitinib 4 mg QD oral
15812551|NCT04346147|Other|Supportive tratment|Any therapeutic intervention aimed at the control of clinical deterioration is contemplated without initiating or having previously initiated any drug with potential beneficial effect previously described in vitro or in pre-clinical / clinical models against SARS-CoV-2 prior to patient recruitment.
15812552|NCT04346134|Procedure|mini-PNL|Percutaneous nephrolithotomy using miniature nephroscope. The procedure will be performed under general or spinal anesthesia under fluoroscopy guidance.
15812553|NCT04346134|Procedure|SWL|Extracorporal shockwave lithotripsy using Dornier SII lithotripter. the procedure will be performed under sedoanalgesia, and fluoroscopy will be used for stone localization; for a maximum of 3 SWL session.
15812554|NCT04346121|Other|GPs reports of potential patient safety incidents, non-COVID-19 related|GPs reports of potential patient safety incidents, non-COVID-19 related
15812555|NCT04346108|Biological|Immune Globulin Intravenous (IGIV)|Participants will receive IGIV infusion.
15812556|NCT04346108|Biological|Immune Globulin Subcutaneous, 20% Solution (IGSC, 20%)|Participants will receive IGSC, 20% SC infusion.
15812557|NCT04346095|Drug|Oral Sedatives with or Without Analgesia|The participants will receive oral triazolam with topical proparacaine and sub-tenon's mixture of lidocaine and marcaine.
15812558|NCT04346095|Drug|Intravenous Sedatives with or Without Analgesia|The participants will receive intravenous midazolam, propofol or fentanyl with topical proparacaine and sub-tenon's mixture of lidocaine and marcaine.
15812559|NCT04346082|Behavioral|online mindfulness group|Each weekly mindfulness session will last 45 to 60 minutes and will be held on an online platform (e.g. Zoom) via a livestream video. It will consist of short mindfulness exercise(s) of 10-30 minutes, including mindful tasting, mindful stretching, mindful walking, and body scan followed by group discussion to share, explore and make sense of the meditative experience. The intervention will be held in Cantonese.
15812560|NCT04346069|Other|PCIT (parent child interaction therapy)|Parent child interaction therapy is a treatment strategy that nurture parent child relationship and teach effective parenting strategies to decrease child non compliance behavior (BodifordMcNeil; Hembree-Kigin, 2010).Parent-Child Interaction Therapy (PCIT; Eyberg; Robinson, 1982 ; Zisser; Eyberg, 2008 ) is a manualized parent training intervention that has received substantial empirical support in the treatment of disruptive behavior across multiple reviews (e.g., Brestan; Eyberg, 1998 ; Gallagher, 2003 ; Thomas &amp; Zimmer-Gembeck, 2007 ). PCIT established strong relation among parenting, social learning, and attachment theories and proceeds.
15812561|NCT04346030|Drug|Triamcinolone Acetonide|ultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine) and 8cc NS
15812562|NCT04346030|Drug|lidocaine hydrochloride|ultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine) and 8cc NS
15812563|NCT04346030|Drug|normal saline|ultrasound guided steroid injection using 1ml of 10mg triamcinolone acetonide (Shincort) mixed with 1ml of 2% lidocaine hydrochloride (Xylocaine) and 8cc NS
15812564|NCT04346017|Diagnostic Test|Cytokines dosage|Dosage of inflammatory cytokines and other markers of systemic inflammatory syndromes (TNFa, IFNg, IL1, IL7, IL10, IL12, IL17, sCD25, sCD163, sCD14, IL-6, IL6-R, complex IL6-IL6R, glycolsylated ferritin...).
15812565|NCT04346017|Diagnostic Test|Complement dosage|Dosage of the complement parameters: CH50, C3, C4, C3d, C5a, SC5b-9, C4a, MASP-2.
15812566|NCT04346004|Drug|Normal saline|"Participants in Control group are administered IV 100cc normal saline & IM normal saline (1cc) 1 day before surgery."
15812567|NCT04346004|Drug|Iron isomaltoside|"Participants in Iron isomaltoside group are administered IV Iron maltoside diluted in 100 cc normal saline (20mg/kg, maximum dose: 1g) & IM Vitamin B12 (1mg) 1 day before surgery."
15812569|NCT04345978|Behavioral|Fasting hours|Normal Fasting hours before CRC surgery for 8 hours and feeding 8 hours after surgery; Prolong fasting hours before CRC surgery for 24 hours and feeding 24 hours after surgery.
15812570|NCT04345965|Procedure|Endovascular procedure|Endovascular therapies for erectile dysfunction
15812605|NCT04345692|Drug|Hydroxychloroquine|oral tablet administered by hospital staff or if discharged before day 5 - self administered oral tablet
15812571|NCT04345952|Behavioral|Calm Meditation Mobile App|The Calm Meditation Mobile App will be used to deliver the meditation intervention to study participants. The Calm app is downloaded onto the participant's smartphone.
15812572|NCT04345939|Diagnostic Test|Detection method|Different methods for pathogen diagnosis
15812573|NCT04345926|Drug|Propofol|Stepped propofol concentration after 20 min of LOS
15812574|NCT04345926|Device|Electroencephalogram recording|Acquisition of EEG activity
15812575|NCT04345913|Drug|Copanlisib Hydrochloride|Given IV
15812576|NCT04345913|Drug|Eribulin Mesylate|Given IV
15812577|NCT04345900|Drug|Plinabulin|a synthetic, low molecular weight, new chemical entity that belongs to the diketopiperazine class of compounds. Plinabulin is intended for intravenous (IV) infusion and is diluted in D5W and administered for 30 minutes (± 5 minutes).
15812578|NCT04345900|Drug|Pegfilgrastim|PEGFILGRASTIM is a long-acting granulocyte colony-stimulating factor that stimulates the growth of neutrophils, to reduce the incidence of fever and infection in patients with certain types of cancer who are receiving chemotherapy that affects the bone marrow.
15812581|NCT04345874|Behavioral|Nutrition technical assistance|Participating family child care home providers in rural counties will be randomized to either the Nutrition Intervention (n=27), or an environmental health comparison group (n=27) that will receive an Integrated Pest Management and Green Cleaning intervention with the same format and visit frequency. Briefly, the Nutrition Technical Assistance Intervention and comparison group will consist of three encounters with our intervention team: two 60-90 minutes virtual one-on-one visits scheduled at the convenience of the family child care home provider and a 3-hour virtual group class session with other providers. Total contact time with intervention staff will be 6 hours. All participants will receive a toolkit. Providers will complete either intervention virtually over a period of three months.
15812582|NCT04345874|Behavioral|Children's environmental health technical assistance|Participating family child care home providers in rural counties will be randomized to either the Nutrition Intervention (n=27), or an environmental health comparison group (n=27) that will receive an Integrated Pest Management and Green Cleaning intervention with the same format and visit frequency. Briefly, the Nutrition Technical Assistance Intervention and comparison group will consist of three encounters with our intervention team: two 60-90 minutes virtual one-on-one visits scheduled at the convenience of the family child care home provider and a 3-hour virtual group class session with other providers. Total contact time with intervention staff will be 6 hours. All participants will receive a toolkit. Providers will complete either intervention virtually over a period of three months.
15812583|NCT04345861|Drug|Hydroxychloroquine + placebo|hydroxychloroquine : 800mg(Day1) then 600 mg (Day 2 to Day 11)
15812584|NCT04345861|Drug|hydroxychloroquine + azithromycin|Combination hydroxychloroquine : 800mg(Day1) then 600 mg (Day 2 to Day 11) Azithromycin 500mg (day 1) then 250 mg (Day 2 to Day 5)
15812585|NCT04345848|Drug|Enoxaparin|Two different doses of anticoagulation
15812586|NCT04345835|Procedure|Percutanous nephrolithotomy (PCNL)|different procedure positioning
15812587|NCT04345822|Procedure|Decompression surgery|The surgeries aim to relieve the myelopathy from cord compression
15812588|NCT04345809|Procedure|MESH WHIT OMEGA-3|Mesh placement with Omega-3 at the umbilical trocar level after laparoscopic cholecystectomy in patients with risk factors for SSI and eventration.
15812589|NCT04345809|Procedure|MESH WITHOUT OMEGA-3|Mesh placement without Omega-3 at the umbilical trocar level after laparoscopic cholecystectomy in patients with risk factors for SSI and eventration.
15812590|NCT04345796|Drug|Carvedilol+Empagliflozin|Group A
15812591|NCT04345796|Drug|Carvedilol|Group B
15812592|NCT04345796|Drug|Empagliflozin|Group C
15812593|NCT04345796|Drug|Placebo|Group D
15812594|NCT04345783|Drug|Camrelizumab for injection, apatinib mesylate and tegio|Camrelizumab for injection: fixed dose of 200 mg, ivgtt for 30 minutes, given on D1, repeat for every 3 weeks; Apatinib mesylate: 250 mg, p.o, qd; Tegio capsule: p.o., bid, D1-14, repeat for every 21 days.
15812595|NCT04345770|Procedure|D2 radical gastrectomy|radical gastrectomy with D2 lymphadenectomy
15812596|NCT04345770|Drug|SOX neoadjuvant or postoperative chemotherapy|Oxaliplatin 130mg/m2 d1, Tegafur,Gimeracil and Oteracil Porassium Capsules 60mg, d1-14.
15812597|NCT04345770|Procedure|Hyperthermic intraperitoneal chemotherapy (HIPEC)|Normal saline 3000ml-4000ml, Paclitaxel 75mg/m2, 5-Fu 15mg/m2, 43°C, 60min.
15812598|NCT04345757|Behavioral|Structured exercise|The exercise program will be designed by a physical therapist (Ms. Patricia Ladis) who specializes in postnatal rehabilitation and will be supervised by sports medicine physicians from the Hospital For Special Surgery (HSS). The structured program will include approximately 10 minutes of core muscle group exercises. They will begin this program 2 weeks after their cesarean section. The study group will perform these exercises 5 times per week.
15812599|NCT04345744|Procedure|Periodontal surgery|Surgery will be performed following a standardized protocol by a single operator (FG). The procedure consists in the performance of a primary full-thickness flap incision, and of a secondary releasing vertical incision of maximum 3 mm limited to keratinized gingiva. At the end of the surgical procedure, soft tissues will be repositioned by means of a suture involving only the primary incision, while it will not be performed on the releasing incision.
15812600|NCT04345744|Device|Hyaluronic and 0.2% chlorhexidine mouth rinse|The mouth rinse protocol assigned to each study participant included a 10 ml-rinse for 60 seconds twice-a-day (every 12 hours) for 14 days.
15812601|NCT04345744|Device|Chlorhexidine 0.2% mouth rinse|The mouth rinse protocol assigned to each study participant included a 10 ml-rinse for 60 seconds twice-a-day (every 12 hours) for 14 days.
15812602|NCT04345731|Other|Over the counter drug labels|A control condition based on the current standard OTC label and 3 experimental labels will be compared to identify OTC labels that more effectively communicate critical information for the reduction of adverse drug events to the consumer
15812603|NCT04345718|Drug|Extended Release Buprenorphine|XR-BUP administration prior to hospital discharge will increase engagement in OUD care on the 34th day following hospital discharge more than is currently afforded by ACS TAU approaches (e.g., methadone, SL-BUP, and naltrexone).
15812604|NCT04345718|Drug|Treatment as Usual|Community standard medication for opioid use disorder (e.g., methadone, sublingual buprenorphine, naltrexone) initiated prior to hospital discharge.
15812606|NCT04345679|Biological|anti-SARS-CoV-2 convalescent plasma|Infusion of one unit of anti-SARS-CoV-2 convalescent plasma ~200 mL over 4 hours
15812607|NCT04345666|Drug|Testosterone cypionate|The intervention of this study is to treat patients to either 1) testosterone cypionate or 2) placebo (sterile saline) to determine if there is a difference in recovery times after arthroscopic rotator cuff repair
15812608|NCT04345666|Drug|Placebos|The intervention of this study is to treat patients to either 1) testosterone cypionate or 2) placebo (sterile saline) to determine if there is a difference in recovery times after arthroscopic rotator cuff repair
15812609|NCT04345653|Drug|Hydroxychloroquine Sulfate (HCQ)|Open-label, consecutive at-risk subjects allocation with chemoprophylaxis with HCQ.
15812610|NCT04345640|Other|no intervention|no intervention
15812611|NCT04345614|Drug|Auxora|Auxora will be given at 2.0 mg/kg (1.25 mL/kg) on Day 1 and then 1.6 mg/kg (1.0 mL/kg) on Days 2 and 3. All doses of Auxora will be administered intravenously (IV) over 4 hours.
15812612|NCT04345614|Drug|Placebo|Placebo will be given at 1.25 mL/kg on Day 1 and then 1.0 mL/kg on Days 2 and 3. All doses of placebo will be administered intravenously over 4 hours.
15812613|NCT04345601|Biological|Mesenchymal Stromal Cells|Patients will be given the cell product by intravenous injection (into the vein through an IV line). Dose:1 x 10^8 MSCs.
15812614|NCT04345601|Other|Supportive Care|Patients will receive supportive care per their treating physician
15812615|NCT04345588|Drug|Dexamethasone injection|we use injection lignocaine 10 mL, injection bupivacaine 0.5% 20 mL, 5 mL normal saline (NS). In group , injection dexamethasone 0.05 mg/kg will be added to the solution along with IV NS 1cc while the other group will receive 0.05 mg/kg injection dexamethasone intravenously.
15812616|NCT04345575|Device|PainCare VR|Didactic content delivered in virtual reality to support participants in learning cognitive and behavioral self-management skills based on cognitive-based therapy, biofeedback, and mindfulness strategies for pain management.
15812617|NCT04345575|Other|Audio content|The audio program consisted of the majority of the same narrative content contained in the VR program. Owing to VR having a visual and auditory media form, about one-third of the VR program could not be included in the audio. Participants accessed 21 audio recordings on SoundCloud and asked to complete one session each day.
15812618|NCT04345562|Procedure|Skin preparation patterns with ChloraPrep 2 x 26 mL single|2 different patterns of skin preparation
15812619|NCT04345549|Other|Individualised Ayurveda|Saline warm water gargle, Steam, Paracetamol for body temperature and plenty fluid and rest, Food and herbs recommendation as per individual Ayurveda constitution, Using Ginger/ lemon/ turmeric/ honey recommended as per individual, Yoga breathing
15812620|NCT04345523|Other|Blood and derivatives.|Administration of fresh plasma from donor immunized against COVID-19
15812621|NCT04345523|Drug|Standard of Care|Standard of care for the treatment of COVID-19 in hospitalized patients
15812622|NCT04345497|Other|Diabetes-Specific Formula|Diabetes-Specific Formula and Standard of Care
15812623|NCT04345497|Other|Standard Of Care|Standard of Care
15812624|NCT04345484|Behavioral|Goal-management training|9-week goal-management program
15812625|NCT04345484|Behavioral|Control|Healthy Lifestyle Program
15812626|NCT04345471|Drug|Desvenlafaxine 100 mg|once daily dosing for 8 weeks
15812627|NCT04345471|Drug|Desvenlafaxine 50 mg|once daily dosing for 8 weeks
15812628|NCT04345471|Drug|Placebo|once daily dosing for 8 weeks
15812629|NCT04345458|Drug|prefilled liquid etanercept(Yisaipu)|
15812630|NCT04345458|Drug|lyophilized etanercept powder(Yisaipu)|
15812631|NCT04345445|Drug|Tocilizumab|IV infusion
15812632|NCT04345445|Drug|Methylprednisolone|IV infusion
15812633|NCT04345432|Drug|Gabapentin|"Gradually increasing doses of medication from 100 mg on day 1 to 300 mg twice a day on day 6. On day 7, the patient received a 300-mg dose from the day 7 envelope, about two hours after a light breakfast and 1 hour before data collection. The relatively low dose and gradual titration were selected to enhance compliance and reduce adverse effects, based on a rectal mechanosensitivity study."
15812634|NCT04345419|Drug|Remdesivir|Remdesivir as antiviral drug
15812635|NCT04345419|Other|Standard of care treatment|Standard of care treatment
15812636|NCT04345406|Drug|ACEIs|Captopril or enalapril
15812637|NCT04345406|Drug|Conventional treatment|alexoquine
15812638|NCT04345393|Behavioral|Digital Transformation Network (DTN) Program|Patients will be screened based on ePRO and online assessment tool results to be identified to be eligible for enrollment into the DTN program. The results of ePROs and online assessments will be used to precision match patients to in-person care at the IBD home or to IBDTx care pathways. RxUniverse platform allows the creation of adaptive pathways based on feedback loops that provide relevant on-demand resources based on patient care touch-points. For example, a patient with mild depression or anxiety, maybe offered an online DTx and if not useful, link to telepsychiatry or in-person psychiatry consultation. Patients will transition into the intervention DTN arm at set intervals by site.
15812639|NCT04345380|Other|Implantation of an Alcon Acrysof SN60WF intraocular lens|Patients suffering from senile cataract getting replaced their human crystalline cataractous lens
15812640|NCT04345380|Other|Implantation of an AMO Tecnis ZCB00 intraocular lens|Patients suffering from senile cataract getting replaced their human crystalline cataractous lens
15812641|NCT04345380|Other|Implantation of an Envista MX60 intraocular lens|Patients suffering from senile cataract getting replaced their human crystalline cataractous lens
15812642|NCT04345367|Drug|Abrocitinib 200 mg|Abrocitinib 200 mg administered as two 100 mg tablets to be taken orally once daily for 26 weeks. Placebo injections will be administered every other week for 24 weeks.
15812643|NCT04345367|Combination Product|Dupilumab 300 mg|Dupilumab 300 mg administered as a single subcutaneous injection every other week for 24 weeks (2 injections on day 1). Placebo tablets will be administered daily.
15812644|NCT04345341|Drug|TAP block with liposomal bupivacaine and bupivacaine|injecting the mixture of bupivacaine with liposomal bupivacaine in transversus abdominis plane to block the somatic nerves
15812645|NCT04345315|Other|serological test|serological test assessing IgM and IgG directed against SARS-CoV-2
15812646|NCT04345315|Other|Rapid molecular test|Molecular test to detect SARS-CoV-2 in oro/rhinopharyngeal swab
15812647|NCT04345315|Genetic|Next generation Sequencing (NGS) analysis|analysis of genetic variability of virus and host
15812648|NCT04345315|Other|serum chemistry analysis|Analysis of serum chemistry factors and coagulation panel in blood samples
15812649|NCT04345302|Behavioral|Brief motivational treatment|"The treatment will be delivered by general psychologists with at least three years of experience in primary care. They will receive training and then will demonstrate proficiency in a simulated client session.
~During recruitment, therapy sessions will be recorded, and ten percent of them will be reviewed using a proficiency scale. Then, a feedback report will be issued and discussed with each therapist."
15812650|NCT04345302|Behavioral|Enhanced Usual Care|During the trial, participants will continue to receive regular medical and social care at their health centre. These services may include prescriptions for mental health issues and alcohol (Disulfiram, anti-craving, anti-depressants, and other medications), social assistance, and the full spectrum of primary health care. Nevertheless, they will not receive other psychosocial interventions for alcohol use disorder in the health centre.
15812651|NCT04345289|Biological|Convalescent anti-SARS-CoV-2 plasma|Single infusion of convalescent anti-SARS-CoV-2 plasma (2 x 300 mL)
15812652|NCT04345289|Other|Infusion placebo|Saline 0.9% (600 ml) as an iv single dose infusion
15812653|NCT04345276|Drug|Danoprevir+Ritonavir|Danoprevir 100mg , one tablet each time , twice per day, up to 10 days. Ritonavir 100mg, one tablet each time , twice per day, up to 10 days.
15812654|NCT04345263|Procedure|MTA pulpotomy|Cutting the coronal portion of the pulp to the level of canal orifices and applying the dressing and restoration
15812655|NCT04345250|Other|Energy restriction|A 25% reduction in total caloric intake, as calculated through the app. Therefore, during the control period, participants will input what they consume into the Eat This Much app, then the app will calculate the 25% reduction in calories to present participants with how much to consume of the same foods. By doing this their diet will not be altered in terms of macronutrients or micronutrients, but solely on calories.
15812656|NCT04345237|Dietary Supplement|dietary supplement consumption|"Consumption of the product under study for 3 months, milk placebo or experimental product (leucine milk).
~In addition, 5 of the arms perform physical activity training"
15812657|NCT04345224|Other|Dynamic tape|A kinesiology tape will be applied to the lateral hip of the affected side to facilitate the gluteus medius muscle activation while the participant is lying down. The first third of one I-strip will begin at the posterior iliac crest without tension to provide an anchor that will not cross the target tissue. The participant will actively flex the adducted hip to allow for the application of the middle third of the tape with approximately 50 percent tension (able to visualize the wave pattern in the tape). Subsequently, with the leg in the original position, the remainder of the tape will be applied without tension, ending approximately at the greater trochanter. Afterward, the second I-strip will be applied in the same manner starting at the anterior iliac crest.
15812658|NCT04345224|Other|Rigid tape|The rigid tape will be applied in a standing position. The first tape will be applied from the greater trochanter to the anterior iliac crest. The second from the greater trochanter to the posterior iliac crest. Both tapes are applied with the muscle mass lifted towards the iliac crest.
15812659|NCT04345224|Other|Sham tape|The control group (sham tape application) will receive a single strip of a Kinesio tape across the lateral affected hip without tension in the tape or muscle stretch.
15812660|NCT04345211|Other|Group1, walking group|The walking group includes a weekly walking goal of 75 minutes.
15812661|NCT04345211|Other|Group 2, Walking plus manual therapy|Walking plus self-administered thorax manual therapy
15812662|NCT04345211|Other|Group 3; Walking plus exercises with Theraband|Walking plus thorax exercises with Theraband
15812663|NCT04345198|Procedure|Adrenal Artery Ablation|Intervention with adrenal artery ablation is performed in PA patients with resistant hypertension.
15812664|NCT04345185|Other|Infant egg consumption (i.e., age of introduction and frequency of intake)|
15812665|NCT04345172|Device|sub-Tenon's block with a lacrimal dilator group or a Wescott scissors|"Local anaesthetic eye drops were installed into the conjunctiva, followed by iodine 5% aqueous drops to the conjunctival sac for 3 minutes.19 An eye lid speculum was inserted.
~In group LD, the conjunctiva and Tenon's capsule were lifted together tightly with a blunt forceps like a tent in the inferonasal quadrant and a punctal dilatator (Castroviejo Lacrimal Dilatator, Katena Products, Inc, Denville, NJ, USA) was placed tangential to the globe creating a round and small hole at 5 mm posterior to limbus (Fig.1). The block was performed using smooth rounded tip, 19 G, 1 inch sub-Tenon's cannula (Visitec, Beaver-Visitec International Ltd, Warwickshire, UK).
~In Group WS, after lifting the conjunctiva and Tenon's capsule together with a blunt forceps, incision was performed with a blunt tip Westcott scissors in the inferonasal conjunctival at 5 mm posterior to limbus to expose sub-Tenon's space."
15812666|NCT04345159|Other|Questionnaire by phone call|"2 questionnaires : at inclusion and 4 months later. The exposure to hydroxychloroquine and the history of autoimmune disease is determined during the phone call along with other exposure factors. The symptoms presented by the patient are classified in Suggestive of a COVID-19 infection or Not suggestive of COVID-19 infection by a team of internists and infectious diseases specialists, by studying the questionnaires after the completion in a blind-manner regarding the hydroxychloroquine intake."
15812667|NCT04345146|Combination Product|FSRT combined with Bevacizumab|"Bevacizumab: Patients will receive Bevacizumab (7.5mg/kg, q3w, IV) before and after FSRT.
~Fractionated stereotactic radiotherapy(FSRT): 40 Gy/10 fractions or 30 Gy/5 fractions for GTV will be delivered to brain metastases."
15812668|NCT04345133|Device|Dental Implants Insertion Drilling Sequence|Drilling sequence protocol to insert immediate Dental Implants at the Maxilla.
15812669|NCT04345120|Drug|SY-008|The subjects were admitted to the clinical trial center two days before the administration period (D-2), fasted for 10 hours overnight on the day before the Administration (D-1), and banned water for 1 hour before the administration. Take sy-009 test drug or placebo immediately before meal (QD is before breakfast, bid is before breakfast and dinner) in the morning of the first day of administration, and deliver it with not more than 200ml warm boiled water. From the day 2 (D2) to the day 7 (D7) before dinner, the oral cavity of the subjects was checked for residual drugs after each administration.
15812670|NCT04345120|Drug|SY-008 matching placebo|SY-008 matching placebo
15812703|NCT04344847|Procedure|Laparoscopic sleeve gastrectomy|Excision of Gastric GIST along fundus or body of stomach in the same specimen of LSG with safety margin 1-2cm
15812704|NCT04344834|Diagnostic Test|A questionnaire or scales|A questionnaire or scale to assess the participants mental health.
15814549|NCT04329494|Drug|Fluorouracil|Given IV
15812671|NCT04345107|Drug|SY-009|The subjects were admitted to the clinical trial center two days before the administration period (D-2), fasted for 10 hours overnight on the day before the Administration (D-1), and banned water for 1 hour before the administration. Take sy-009 test drug or placebo immediately before meal (QD is before breakfast, bid is before breakfast and dinner) in the morning of the first day of administration, and deliver it with not more than 200ml warm boiled water. From the day 2 (D2) to the day 7 (D7) before dinner, the oral cavity of the subjects was checked for residual drugs after each administration.
15812672|NCT04345107|Drug|SY-009 matching placebo|SY-009 matching placebo
15812673|NCT04345094|Other|Hexylresourcinol|Emulsion containing hexylresorcinol as an active
15812674|NCT04345094|Other|Hydroquinone|Emulsions containing hydroquinone as an active
15812675|NCT04345081|Procedure|Skin Reducing Nipple Sparing Mastectomy and Implant Based Breast Reconstruction|Skin Reducing Nipple Sparing Mastectomy is performed from Inverted T incisuion and nipple is preserved.
15812676|NCT04345081|Procedure|Skin- Sparing Mastectomy and Implant- Based Breast Reconstructive Surgery|Classic Skin- Sparing Mastectomy
15812677|NCT04345068|Behavioral|Calm Meditation Mobile App|The Calm app is downloadable by participants onto their smartphone. The Calm app is used to deliver the meditation intervention to experimental group participants.
15812678|NCT04345068|Behavioral|Health Education Podcast Mobile App|The health education podcast mobile app mirrors the intervention group's app experience, but provides educational content via podcasts as an active comparator.
15812679|NCT04345055|Other|Treatment of the lumbar fasciae|Treat the lumbar facial with a manual technique
15812680|NCT04345055|Other|Placebo intervention|Introduce in a machine off
15812681|NCT04345042|Other|Classic Massage (Swedish Technique)|Classic Massage (Swedish Technique); The massage was applied to the paitents with NP in the second group. Massage procedure included 3 strokes, 3 kneads, and 3 strokes to the upper back and neck area. The application was supported by face cradle and carried out in a semi-horizontal position in which the neck was relaxed. The patient was lying in supine position.
15812682|NCT04345029|Dietary Supplement|Dietary supplement consumption|"The experimental product consumption time was 60 days and the control consumption time was 60 days.
~Each subject must consume both products, with a washing period of 30 days."
15812683|NCT04345016|Device|Once-daily remote foot temperature monitoring|Participants were provided a once-daily remote foot temperature monitoring mat (Podimetrics SmartMat; Podimetrics Inc., Somerville MA) which they used for one year or until dying, dropping out of the study, or disenrolling at a member of the health plan administering the study.
15812684|NCT04345003|Device|Myoma elastography|"The standard pre-therapeutic assessment includes a pelvic US to eliminate the presence of calcification of fibroids. If this absence is confirmed, the elasticity of uterine myoma (by ARFI method) will be measured.
~The standard pre-therapeutic MRI performed allows to classify and measure the myoma in order to determine if it is accessible for HIFU treatment. MRI elastography sequence with the Resoundant® system will be performed during this exam."
15812685|NCT04344990|Procedure|Epidural analgesia - Group E|Postoperative analgesia with continuous epidural infusion (control group) with Ropivacaine 0.2% + clonidine 150μg with PCA pump (2ml/h and bolus dosage 0,5ml per 15min)
15812686|NCT04344990|Procedure|Femoral blockade - Group F|Postoperative analgesia with continuous femoral nerve blockade infusion with Ropivacaine 0.2% + clonidine 150μg with PCA pump (2ml/h and bolus dosage 0,5ml per 15min) .
15812687|NCT04344990|Procedure|Intraarticular infusion - Group I|Postoperative analgesia with continuous intraarticular infusion with Ropivacaine 0.2% + clonidine 150μg with PCA pump (2ml/h and bolus dosage 0,5ml per 15min)
15812688|NCT04344964|Other|None - NA|Observational study
15812689|NCT04344951|Drug|UNIKINON (Chloroquine phosphate) 200mg tablets|Two and a half tablets (500mg) twice daily for seven days.
15812690|NCT04344938|Other|questionnair about Emerging Legal and Ehical Disputes Over Patient Confidentiality|Many critical ethical questions arise in pandemic covid 19planning, preparedness and response. These include: Who will get priority access to medications, vaccines and intensive care unit beds, given the potential shortage of these essential resources? In the face of a pandemic, what obligations do health-care workers have to work notwithstanding risks to their own health and the health of their families? How can surveillance, isolation, quarantine and social-distancing measures be undertaken in a way that respects ethical norms? What obligations do countries have to one another with respect to pandemic covid 19 planning and response efforts?
15812691|NCT04344925|Device|Aerosol-reducing Mask|Patient will be put on BIPAP using the aerosol-reducing mask. In the case where the patient is located in a care area where BIPAP is prohibited with a standard mask, they will assigned the aerosol-reducing mask.
15812692|NCT04344925|Device|Standard Mask|Patient will be put on BIPAP using the standard mask
15812693|NCT04344912|Other|Data collection|Diagnostic and prognostic evaluation of cardiac patients hospitalized in CCU during the COVID-19 outbreak; patient's immune status regarding the presence of SARS-CoV-2 specific antibodies
15812694|NCT04344899|Other|Observational|Enhanced Recovery After Surgery protocol at five tertiary-care pediatric hospitals in pediatric patients undergoing abdominal or retroperitoneal surgical resections for cancer.
15812695|NCT04344886|Procedure|Conventional (dual-phase) SPECT/CT|Conventional (dual-phase) SPECT/CT (after 10 and 150 minutes)
15812696|NCT04344886|Procedure|Multi-phase SPECT/CT|Multi-phase SPECT/CT (after 10, 90, 150, 210 minutes)
15812697|NCT04344886|Procedure|Conventional minimally-invasive radio-guided parathyroidectomy|Conventional minimally invasive radio-guided parathyroidectomy in a time span of 2-3 hours from radionuclide administration
15812698|NCT04344886|Procedure|Individualised minimally-invasive radio-guided parathyroidectomy|Individualized minimally-invasive radio-guided parathyroidectomy performed in a recommended time span based on standardized uptake value calculation.
15812699|NCT04344873|Other|Placebo|Placebo injection at day one and day fourteen.
15812700|NCT04344873|Drug|Abatacept 10 mg/kg|Abatacept injection at day twenty eight and day forty two.
15812701|NCT04344860|Drug|Recombinant Von Willebrand factor|Recombinant Von Willebrand factor(Vonvendi) is an intravenous therapy that replaces missing VWF to restore hemostasis and reduce bleeding with surgery or delivery.
15812702|NCT04344860|Drug|Tranexamic Acid Injection [Cyklokapron]|Tranexamic acid (Cyclokapron) is an intravenous anti-fibrinolytic therapy that prevents clot breakdown and reduces bleeding with surgery or delivery.
15812705|NCT04344821|Dietary Supplement|Curves Calcium|"Dietary Supplement: Curves Calcium
~Curves Essential Bio-Available Calcium (providing 800 mg/d of calcium [as calcium citrate malate and calcium citrate], 400 IU of Vitamin D, 300 mg/d of magnesium, 4 mg/d of zinc, 2 mg/d of copper, 2 mg/d of manganese, 198 mg/d of potassium, 100 mg/d of trace mineral complex, and 2 mg/d of boron)"
15812706|NCT04344821|Dietary Supplement|Placebo|Dextrose Placebo
15812707|NCT04344808|Device|Dynamic navigation system|The navigation system allows clinicians, using a specific software, to visualize the position of the surgical drill (tip location and shaft axis direction) on the reconstructed 3D image of the pre-acquired CBCT. The software guides the surgeon, in real-time, to the preoperative planned position.
15812708|NCT04344808|Device|Freehand implant placement|Dental implants will be placed without any guidance once a virtually planning of the ideal position on the CBCT is done
15812711|NCT04344782|Drug|Bevacizumab Injection|Treatment includes the administration on day 1 (D1) of an infusion of Bevacizumab 7.5 mg / kg in 100 ml saline for all patients weighing 100 kg or more. In control arm, patient receives standard care.
15812712|NCT04344756|Drug|Tinzaparin or unfractionated heparin|Tinzaparin INNOHEP ® 175 IU/kg/24h for 14 days if creatinine clearance Cockcroft ≥ 20mL/min, Otherwise unfractionated heparin (Calciparine®, Héparine Sodique Choay®) subcutaneously or intravenous with an anti-Xa target between 0.5 and 0.7 IU/mL for 14 days
15812713|NCT04344743|Device|Cryoballoon ablation without contrast|Cryoballoon ablation without contrast
15812714|NCT04344730|Drug|Dexamethasone injection|Box of 10 DEXAMETHASONE 20 mg / 5 ml, solution for injection in ampoule of 5mL. Each allocated box contains complete treatment from D1 to D10 for one patient.
15812715|NCT04344730|Drug|placebo|Box of 10 NaCl 0,9% , solution for injection in ampoule of 5mL. Each allocated box contains complete treatment from D1 to D10 for one patient.
15812716|NCT04344730|Procedure|conventional oxygen|The oxygen flow will be adjusted to maintain an oxygen saturation level of 92% or more, as measured by means of pulse oximetry (SpO2)
15812717|NCT04344730|Procedure|CPAP|Patients assigned to the CPAP plus oxygen group will receive periods of CPAP in addition to the standard treatment.The oxygen flow will be adjusted to maintain an oxygen saturation level of 92% or more, as measured by means of pulse oximetry (SpO2)
15812718|NCT04344730|Procedure|HFNO|TIn the high-flow-nasal cannula group, oxygen will be delivered through a heated humidifier (Airvo-2, Fisher and Paykel Healthcare) and applied continuously through large-bore binasal prongs, with a gas flow rate of 30 liters per minute and adjusted based on the clinical response. FiO2 will be adjusted for the target SpO2
15812719|NCT04344730|Procedure|mechanical ventilation|The oxygen flow will be adjusted to maintain an oxygen saturation level of 92% or more, as measured by means of pulse oximetry (SpO2)
15812720|NCT04344717|Drug|Apixaban single dose|A single dose of apixaban 2.5 mg and/or 5 mg will be administered and PK characteristics will be measured
15812721|NCT04344704|Other|Single chamber DAI device with floating atrial dipole|DAI for the detection of atrial signals with optimized programming, using Smart, Onset & Stability, and Morphmatch methods
15812722|NCT04344691|Procedure|Rectus femoris stretching|Patient lying prone with the non-implicated leg outside the treatment table resting on the floor. Physical therapist flexes patients knee until tension is felt. In that position 5 seconds' isometric contraction is asked and physical therapist progresses in knee flexion range of motion until new tension is felt. After three contract-relax procedures physical therapist holds the range of motion for 30 seconds.
15812723|NCT04344678|Drug|Sildenafil Citrate|Esitalopram 20 mg tablet plus Sildenafil Citrate 50 mg tablet once daily
15812724|NCT04344678|Drug|Placebo oral tablet|Esitalopram 20 mg tablet plus placebo tablet once daily
15812725|NCT04344665|Other|Virtual Care and Remote Automated Monitoring|Patients will measure daily vitals (blood pressure, heart rate, respiratory rate, oxygen saturation, temperature, weight) with remote monitoring technology and complete recovery surveys daily in home after discharge from hospital. Patients will interact with a virtual nurse daily on days 1-15 and every other day from days 16-30. If the patient's RAM measurements exceed predetermined thresholds, the patient reports specific symptoms (e.g., shortness of breath), a drug error is identified, or the virtual nurse has concerns about the patient's health that they cannot resolve, the virtual nurse will escalate care to a pre-assigned and available physician. Physicians will add or modify treatments as needed, and if required, they will have the patient come to an outpatient facility for evaluation or management. Via secure video or text messaging, patients will also have access to a virtual nurse at night, for any urgent issues.
15812726|NCT04344652|Device|Photoscreening -|external picture taken with a an phone based app
15812727|NCT04344639|Other|the incidence, risk factors, treatment, prognosis of necrotizing enterocolitis in newborn infants born in newborn intensive care units in our country|With this project, which is planned as a national multicenter prospective study, the incidence of necrotizing enterocolitis in newborn infants born in newborn intensive care units in our country and the risk factors associated with the disease, especially the detailed feeding history of the patient (when the first feeding is nourished, antibiotics and other treatments that are being used). Most epidemiological data such as the most common stage of the disease, treatment, prognosis, comparison with the data of other countries will provide important information for the neonatal health of our country.
15812728|NCT04344626|Device|Intra-operative brain tonometry|Once the brain is exposed during surgery, a sterilized digital tonometer will be used to obtain brain tissue stiffness measurements at various locations of the cortex established based on results of pre-operative work-up. Precise stereotactic coordinates for each measurement will be recorded in a neuronavigation software to facilitate comparisons with results of other tests.
15812729|NCT04344613|Device|ABODpoct device|The device has been developed by a consortium including the Université Libre de Bruxelles, research centers (SIRRIS, CER), a private company (CISEO), and the spin-off Antigon S.A..The device includes a reader and a disposable disk (ABOD disk) for testing one patient et a blood bag. Four blood drops from the patient are deposited on one side of the disk and 4 blood drops from the blood bag one the other side. The disk correctly filled is inserted in the reader and after 2 minutes the result is displayed on the screen as a message GO or No GO. In case of incompatibility or any other problem a red Stop message will appear on the screen.
15812730|NCT04344600|Drug|Peginterferon lambda alfa-1a subcutaneous injection|Peginterferon lambda-1a 180 micrograms by subcutaneous injection
15812731|NCT04344600|Other|Saline|Saline subcutaneous injection
15812732|NCT04344587|Other|Self-prone position recommendation|"The Qualtrics self-prone position recommendation intervention website will include the following sections:
~Welcome message
~Educational review of the potential benefits of prone positioning
~How-To guide to safely prone in a hospital bed
~A recommendation to prone while lying in bed (4 times for 1-2 hours each during the day and at night every 24 hours).
~A reminder to keep track of the time spent in 1) prone position, 2) lying flat on back, 3) lying on side, 4) sitting up, and 5) standing or walking"
15812733|NCT04344587|Other|Usual care|"The Qualtrics usual care website will include the following sections:
~Welcome message
~A reminder to keep track of the time spent in 1) prone position, 2) lying flat on back, 3) lying on side, 4) sitting up, and 5) standing or walking"
15812734|NCT04344561|Other|Postural Positioning|Investigators will adjust the positioning of hospital beds to assess improvements in oxygenation and respiratory status.
15812735|NCT04344548|Biological|Allogeneic NK transfer|Three doses of allogeneic NK cell transfer
15812736|NCT04344535|Biological|Convalescent Plasma|450-550 mL of plasma containing anti-SARS-CoV-2 antibody titer ideally > 1:320, but meeting minimum titer per FDA Guidelines for convalescent plasma.
15812737|NCT04344535|Biological|Standard Donor Plasma|450-550 mL of plasma with low titer to anti-SARS-CoV-2 antibodies
15812738|NCT04344522|Procedure|Descemet membrane endothelial keratoplasty DMEK|DMEK : it involves separating the Descemet membrane from a corneal donor graft , doing a descematorhexis in the recepient cornea , loading and injection of the graft into the anterior chamber , unfolding and fixing the graft to the recepient cornea by intracameral air bubble.
15812739|NCT04344522|Procedure|IOL exchange|IOL exchange : it involves performing a corneoscleral tunnel , freeing the AC IOL from any adhesions and explanting it through the tunnel , then implanting a posterior chamber PMMA lens or iris claw lens if there is no adequate capsular support.
15812740|NCT04344522|Procedure|iridoplasty|iridoplasty : repairing any iris defect by using 10/0 prolene.
15812741|NCT04344522|Procedure|Inferior peripheral iridectomy|Inferior peripheral iridectomy : performed by vannus scissor to avoid postoperative pupillary block due to the intracameral air .
15812742|NCT04344509|Other|Bacterial species isolated|in the respiratory specimen
15812743|NCT04344496|Other|PAM50|PAM50 results is as one of the references for the physicians and the participants to choose adjuvant treatments.
15812744|NCT04344483|Drug|2% Lidocaine and 1:100,000 Adrenaline|Topical application of 2% Lidocaine and 1:100,000 Adrenaline in the form of dressing will be applied over skin graft donor site of thigh for 10 minutes.
15812745|NCT04344483|Drug|Normal saline|Topical application of Normal saline will be applied over skin graft donor site of thigh as a control group.
15812746|NCT04344470|Device|EMG|EMG will be recorded from two electrodes placed on both extensor carpi radialis (ECR) muscles
15812747|NCT04344470|Device|EEG|EEG electrodes will be positioned according to 10-20 International System, with every impedance kept under 5 kOhm. EEG data will be amplified, filtered (DC-100 Hz), digitized at 1000 Hz, and stored on a computer for offline analysis.
15812748|NCT04344457|Drug|Hydroxychloroquine|200 mg PO BID 7 days
15812749|NCT04344457|Drug|Indomethacin|50 mg PO TID 14 Days
15812750|NCT04344457|Drug|Zithromax Oral Product|500 mg PO QD 3 Days
15812751|NCT04344444|Drug|Hydroxychloroquine|tablets provided as described in Arm B
15812752|NCT04344444|Drug|Azithromycin|tablets provided as described in Arm C
15812753|NCT04344431|Combination Product|Hyperbaric oxygen treatment (HBOT) i.e. inhalation of pressurized oxygen delivered by a hyperbaric chamber (drug/device)|One session per day of HBOT in addition to the standard treatment with normobaric oxygen
15812754|NCT04344418|Device|Nurse-performed Focused cardiac ultrasound (FoCUS)|A FoCUS-trained nurse will perform a FoCUS examination within 30 minutes of triage by the triage clinician. The Philips Lumify® handheld ultrasound device (HUD) with a phased array probe will be used and studies limited to a maximum of 10 minutes each. A presumptive diagnosis will then be selected by the nurse from a FoCUS checklist based on pre-defined thresholds for each FoCUS target condition and the time the diagnosis is made recorded. Additional imaging and lab tests may be requested at the discretion of the clinical team but the FoCUS nurses will be blinded to the results of these.
15812755|NCT04344418|Other|Usual care|The control arm will consist of usual care ie a combination of physical examination, lab tests and imaging. The need for a formal echocardiographic evaluation by a cardiologist or cardiac sonographer in patients assigned to the control arm will be at the discretion of the clinical teams, as is usual care at KNH and AKUHN
15812756|NCT04344405|Drug|Vitamin D|vitamin D supplementation
15812757|NCT04344405|Drug|Steroid Drug|control
15812758|NCT04344392|Diagnostic Test|Ultrasonographic study|Thyroid hyoid approximation and hyoid anterior replacement during swallowing. Tongue thickness in rest.
15812759|NCT04344392|Diagnostic Test|Videofluoroscopic study temporal parameters|Glossopalatine junction opening and closing time, velopharyngeal junction opening and closing time, laryngeal vestibule opening and closing time, upper esophageal sphincter opening and closing time in seconds.
15812760|NCT04344392|Diagnostic Test|Videofluoroscopic study distance parameters|Hyoid bone horizontal and vertical replacement, thyroid-hyoid approximation (THA) in millimeters.
15812761|NCT04344379|Drug|hydroxychloroquine|200 mg BID per day
15812762|NCT04344379|Drug|azithromycin|250 mg per day
15812763|NCT04344379|Drug|hydroxychloroquine placebo|200 mg BID per day
15812764|NCT04344340|Diagnostic Test|clinical examination|clinical examination
15812765|NCT04344314|Device|Peripheral Intravenous Catheter|Randomised controlled
15812766|NCT04344301|Other|Audio recording|The investigators will audio record the visits of patients in the intervention group. An RA will enter the exam room and begin the recording with the patient's permission. The patient and clinician can choose to stop or start the recording at any time. Once the visit is complete, the RA will enter the room, turn off the recording, and bring the patient to a private room where the RA will follow standardized instructions demonstrating how to access recordings. Patient access to recordings will be possible via a secure web-based platform. Patients will also receive reminders to listen to their recordings.
15814550|NCT04329494|Procedure|Intraperitoneal Chemotherapy|Undergo PIPAC
15812767|NCT04344288|Drug|Prednisone|The experimental group will receive oral prednisone during 10 days (0.75 mg/kg/day during 5 days then 20 mg/day during 5 more days)
15812768|NCT04344288|Other|Control group|The control group will receive standard of care according to the international recommendations and practices of the investigational site. No corticosteroid therapy can be prescribed in this group.
15812769|NCT04344275|Other|-Scapular endurance test|The resistance of the trapezius and serratus anterior muscles to fatigue was assessed using the scapular muscle endurance test.
15812770|NCT04344275|Other|-Muscle strength test|Upper trapezius (UT), middle trapezius (MT), lower trapezius (LT), and serratus anterior (SA) muscle strengths were tested using a hand-held digital dynamometer (Lafayette Manual Muscle Tester, Model 01165).
15812771|NCT04344262|Drug|Atracurium Besylate regular dose|"Intubating dose of muscle relaxant will be atracurium 0.5 mg/kg
~Maintenance doses of muscle relaxant will be given throughout the intraoperative period
~to maintain the Train-of-four values continuously less than 2"
15812772|NCT04344262|Drug|Atracurium Besylate minial dose|atracurium boluses of muscle relaxant given only upon complain of the surgeon and after a bolus dose of propofol 0.5 mg/kg. When required, 20% of the initial dose of muscle relaxant will be provided as a bolus to achieve this goal
15812773|NCT04344236|Drug|Saline oral/nasal rinse|5 cc of nasal rinses total for both nostrils + 20 cc of oral gargles, 4 times a day, for 7 days.
15812774|NCT04344236|Drug|0.5% Povidone/Iodine oral/nasal rinse|5 cc of nasal rinses total for both nostrils + 20 cc of oral gargles, 4 times a day, for 7 days.
15812775|NCT04344236|Drug|0.12% Chlorhexidine oral/nasal rinse|5 cc of nasal rinses total for both nostrils + 20 cc of oral gargles, 4 times a day, for 7 days.
15812776|NCT04344223|Device|Balance Shoe|Use of experimental balance shoes for carrying out the tests along the three sessions and one of the two familiarization phases
15812777|NCT04344223|Device|Personal Shoe|Use of Personal shoes (the same for each session) for carrying out the tests along the three sessions and one of the two familiarization phases
15812778|NCT04344210|Behavioral|Tele-interventions related to diabetes management and mental well-being|Participants will receive a tele-intervention by a case manager weekly to discuss topics related to diabetes management and mental well-being during the quarantine period
15812779|NCT04344197|Other|global survey|surgery questionnaire
15812780|NCT04344184|Drug|L-ascorbic acid|50 mg/kg intravenous vitamin C infusion every 6 hours for up to 96 hours
15812781|NCT04344184|Other|Placebo|Dextrose 5% Water
15812782|NCT04344158|Drug|AK105 Injection|AK105 200mg intravenously (IV) on day 1 of each 21-day cycle.
15812783|NCT04344158|Drug|Anlotinib Hydrochloride Capsules|Anlotinib capsules 10mg given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
15812784|NCT04344158|Drug|Sorafenib Tosylate Tablets|Sorafenib Tosylate Tablets 400mg given orally, twice daily in 21-day cycle.
15812785|NCT04344132|Procedure|Scalp Block|standard practice of controll the pain after surgery. Block of the nerve emergences.
15812786|NCT04344106|Procedure|Prone positioning|The prone positioning consists of placing the patient on his or her stomach with the head on the side, during sessions lasting several hours a day.
15812787|NCT04344093|Device|Patch validation|Use of connected patch to collect blood pressure, heart rate, respiratory rate, arterial oxygen saturation and temperature
15812788|NCT04344080|Device|CytoSorb-Therapy|Additional use of Cytosorb-Adsorber in patients with COVID-19 and need for extracorporeal circulation (continuous renal replacement therapy or extracorporeal membrane oxygenation)
15812789|NCT04344067|Device|Far Infrared Therapy|The WSTM TY101 FIR emitter (WS Far Infrared Medical Technology Co., Ltd., Taipei, Taiwan) was used to conduct FIR therapy in this study. The electrified ceramic plates of the emitter generated electromagnetic waves with wavelengths in the range between 3 and 25 μm (a peak between 5 to 6 μm). The irradiating power density is 10 and 20 milliwatt (mw) /cm2 when the top radiator was set at a distance of 30 and 20 cm above the skin surface respectively.
15812790|NCT04344054|Biological|RV3-BB|1.0 mL of the thawed rotavirus vaccine to be administered orally at birth, 6 weeks and 10 weeks of age
15812791|NCT04344054|Biological|Trivalent P2-VP8|0.5 mL of vaccine containing 90 μg of the TV P2-VP8 antigen; IM; at approximately 6, 10 and 14 weeks of age
15812792|NCT04344054|Biological|Rotarix|1.5 mL of the liquid vaccine containing the RIX4414 strain of human rotavirus vaccine to be administered orally at 6 weeks and 10 weeks of age.
15812793|NCT04344054|Biological|RV3-BB birth dose|1.0 mL of the thawed rotavirus vaccine to be administered orally at birth.
15812794|NCT04344054|Biological|Trivalent P2-VP8 Booster dose|0.5 mL of vaccine containing 90 μg of the TV P2-VP8 antigen; IM; at 14 weeks of age
15812795|NCT04344041|Drug|cholecalciferol 200,000 IU|Patients receive a vitamin D supplementation of 400,000 IU in a single oral dose.
15812796|NCT04344041|Drug|cholecalciferol 50,000 IU|Patients receive a vitamin D supplementation of 50,000 IU in a single oral dose
15812797|NCT04344028|Behavioral|True Cognitive Training Program|The training program is a personal device-based adaptive version of a visual N-back task.
15812798|NCT04344028|Behavioral|Control Cognitive Training Program|The training program is a personal device-based adaptive version of a knowledge task (control).
15812799|NCT04344028|Behavioral|Positive Expectation Induction|The message given to the participants emphasizes that the given training results in a positive change in cognitive abilities.
15812800|NCT04344028|Behavioral|Negative Expectation Induction|The message given to the participants emphasizes that the given training results in a negative change in cognitive abilities.
15812801|NCT04344015|Other|Plasma Donation|Previously infected COVID-19 patients will be recruited to donate convalescent plasma.
15812802|NCT04343989|Drug|Clazakizumab 25 mg|The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 25 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 25 mg clazakizumab will be given no later than day 3.
15812831|NCT04343755|Biological|Convalescent Plasma|Fresh or frozen plasma will be infused one time to hospitalized patients with COVID-19 infection
15813090|NCT04341454|Drug|DWP14012 X mg placebo|DWP14012 X mg placebo-matching tablet, orally, once daily for 2 weeks
15812803|NCT04343989|Drug|Clazakizumab 12.5 mg|The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Clazakizumab 12.5 mg arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of 12.5 mg clazakizumab will be given no later than day 3.
15812804|NCT04343989|Other|Placebo|The first dose will be administered as soon as possible after the patient is enrolled and randomized into the Placebo arm. The route of administration will be intravenous. Each dose will be administered as an infusion that is run over 30 minutes. Serum CRP will be evaluated at baseline and on days 1 and 2 following clazakizumab administration. If the CRP does not decrease by 50% within 36-48 hours after the first dose, a second dose of placebo will be given no later than day 3.
15812805|NCT04343976|Drug|Pegylated interferon lambda|180 mcg subcutaneous injection of pegylated interferon lambda
15812806|NCT04343963|Drug|Pyridostigmine Bromide|One 60mg tablet P.O. once per day for 14 days
15812807|NCT04343963|Drug|Placebo|One tablet P.O. once per day for 14 days
15812808|NCT04343950|Behavioral|SMS reminders to enhance colorectal cancer screening|"Cluster randomization instead of individual randomization will be used. The cluster will be invitation week.
~Individuals assigned to the experimental arm with a wrong phone number will get a reminder letter (protocol analysis)."
15812809|NCT04343950|Behavioral|SMS reminders to return the fecal immunochemical test at the pharmacy in CRC screening:|"Cluster randomization instead of individual randomization will be used. The cluster will be invitation week.
~Individuals with a wrong phone number assigned to the experimental arm will not get any reminder (protocol analysis)."
15812810|NCT04343950|Behavioral|Invitation by SMS to previous participants in breast cancer screening:|Individual randomization. Women assigned to the experimental arm and with a wrong phone number will get an invitation letter (protocol analysis).
15812811|NCT04343937|Procedure|retrolaminar block|local anesthetic injection on the between the lamina of the vertebra and the paraspinous muscle
15812812|NCT04343924|Other|Scuba diving activities|The subjects of this group daily dive, 5 days per week, for a total of 10 dives at a maximum depth of 6 meters for a maximum duration of 20 minutes in a swimming pool.
15812813|NCT04343924|Other|Virtual reality activities|The subjects of this group will follow virtual reality sessions recreating the environment in which the submarine diver of the GP+ group operates
15812814|NCT04343911|Device|Pink Pad ® (Xodus Medical Inc., New Kensington, PA)|a non-sliding foam mattress
15812815|NCT04343898|Other|No intervention|Observational
15812816|NCT04343885|Drug|177Lu-PSMA-617|Patients will be given 7.5GBq of 177Lu-PSMA every 6 weeks for 2 cycles.
15812817|NCT04343885|Drug|Docetaxel|Docetaxel 75 mg/m2 given every 3 weeks for 6 cycles
15812818|NCT04343872|Behavioral|Receive lifestyle modification alone|Participants will receive a 12-month lifestyle intervention program (telehealth + peer coach). The intervention comprises of the Center for Disease Control and Prevention (CDC)-adapted DPP Prevent Type 2 (PreventT2) lifestyle intervention program consisting of 26 classes delivered by trained health educators via telehealth. Additionally, the peer coach provides ongoing support over 12-months with tapered calls mirroring ongoing classes. Participants are randomized at the practice level. Two clinics will be randomized to receive the lifestyle intervention program alone.
15812819|NCT04343872|Behavioral|Metformin therapy|The two other clinics will be randomized to receive the lifestyle intervention program (described above) with METFORMIN therapy recommendations. Participants are randomized at the practice level. The primary care provider at the clinic will prescribe metformin and participants would be encouraged to take it if the primary care provider consider prescribing.
15812820|NCT04343859|Drug|IMMH-010|"Part A Dose escalation study: 60mg, QD, Cycle0Day1, Cycle1Day1-Cycle N/120mg, QD, Cycle0Day1, Cycle1Day1- Cycle N/240mg, QD, Cycle0Day1, Cycle1Day1- Cycle N/360mg, QD, Cycle0Day1, Cycle1Day1- Cycle N IMMH-010 will be administered until disease progressioncor un-tolerable toxicity or disease progression or the treatment discontinuation criteria specified in the protocol appear.
~Part B Food effect study:120mg(Anticipated), QD, Cycle0Day1, Cycle0Day8, Cycle1Day1- Cycle N. IMMH-010 will be administered until disease progressioncor un-tolerable toxicity or disease progression or the treatment discontinuation criteria specified in the protocol appear.
~Part C Dose expansion study:120mg(Anticipated), QD, Cycle1Day1- Cycle N. IMMH-010 will be administered until disease progressioncor un-tolerable toxicity or disease progression or the treatment discontinuation criteria specified in the protocol appear."
15812821|NCT04343833|Procedure|Immediate dental implants|At the time of operation, the tooth was atraumatically extracted, and the implant was immediately placed following the surgical protocol recommended by the manufacturer. A temporary prosthesis was made without occlusal contact.
15812822|NCT04343820|Procedure|Breast reconstruction|Breast reconstruction by prepectoral positioned implant after lipo-preparation of the wall.
15812823|NCT04343807|Procedure|PECS Block|PECS nerve block will be performed using the ultrasound-guided technique described by Blanco and colleagues. Block will be performed with a 22-gauge 100 mm needle (Stimuplex, B. Braun Medical Inc., Pennsylvania, USA) using Mindray M7 imaging system (Diagnostic Instruments Inc., China) with a high-frequency (6-13 MHz) linear array transducer.20 mL of ropivacaine 0.25% in 5-mL increments will be injected, aspirating gently between injections. The needle will be withdrawn to place the tip in the fascial plane between the pectoralis major and pectoralis minor muscles and ropivacaine 0.25%, 10 ml in 5 ml increments will be injected. Injectate spread between the muscles will be visualized. For patients in control group, no nerve block will be performed and only intravenous nalbuphine will be given.
15812824|NCT04343807|Other|Control Group|No nerve block will be performed and only intravenous nalbuphine will be given.
15812825|NCT04343794|Device|BIOVITALS|Biovitals platform including (1) armband with multiple physiological sensor, (2) remote monitoring, and (3) Analytic platform. The arm will be worn 23 hours a day and off for 1 hour during showering for recharging battery during 24 hr quarantine period
15812826|NCT04343781|Other|observation|observation of clinical symptoms related to COVID-19 disease
15812827|NCT04343768|Drug|Hydroxychloroquine|This Drug will be used in all arms.
15812828|NCT04343768|Drug|Lopinavir / Ritonavir|This Drug will be used in all arms.
15812829|NCT04343768|Drug|Interferon Beta-1A|This drug will be only used in Arm 1.
15812830|NCT04343768|Drug|Interferon Beta-1B|This drug will be only used in Arm 2.
15812832|NCT04343742|Drug|chlorine dioxide 3000 ppm|"Each patient will receive the 3,000 ppm chlorine dioxide base preparation with written and precise instructions on how to prepare and take the dilutions.
~: 10 ml of 3000 ppm chlorine dioxide are added to 1 liter of water, per day. One part is taken every hour, until the content of the bottle is finished (8 to 12 shots)."
15812833|NCT04343729|Drug|Methylprednisolone Sodium Succinate|injectable solution at a dose of 0.5mg/kg
15812834|NCT04343729|Drug|Placebo solution|injectable saline solution
15812835|NCT04343716|Behavioral|Low-carbohydrate diet|A diet low in daily carbohydrates (<40 grams/day) provided as prepared meals.
15812836|NCT04343703|Behavioral|Telephone-based management|The intervention consists of a series of phone calls aimed at providing follow up care of individuals at risk. At each phone call the case manager collects information regarding the current treatment, adherence to mental health services, and current life stressors.
15812837|NCT04343703|Behavioral|iFightDepression for Suicide|The iFD-Survive is a cognitive-behavioral, internet-based self-management tool, developed by the European Alliance Against Depression (EAAD). The iFD is intended to address mild-to-moderate depressive symptoms. The iDF tool is structured in seven core modules focused on: behavioral activation, cognitive restructuring, sleep regulation, mood monitoring, and healthy lifestyle habits. The content of each module is intended to be followed over 1 week and consists of written information, tasks to do over the week and worksheets. All of these aims to consolidate learning and promote self-monitoring. For this study, an additional module (iFD-S) will be developed. The iFD-S also provides telephone guidance (2h per participant).
15812838|NCT04343703|Behavioral|Treatment as Usual|Treatment as Usual (TaU) will vary across sites, however it generally implies a combination of case management strategies (including telephone calls, visits by mental health services) and pharmacotherapy. For this study, any nonspecific intervention to address suicidal behavior or to prevent suicide will be considered as treatment as usual.
15812839|NCT04343703|Behavioral|Self Awareness of Mental Health|The SAM consist of five, face-to-face, individual sessions designed to raise awareness about depression, anxiety and suicidal behaviors as well as to enhancing skills to effectively cope with stressful life events and mood.
15812840|NCT04343690|Behavioral|Crisis management coaching|Crisis management coaching will be offered to faculty, staff, and trainees dealing with COVID-19 pandemic
15812841|NCT04343651|Drug|Placebos|Placebo
15812842|NCT04343651|Drug|Leronlimab (700mg)|Leronlimab (PRO) 140 is a humanized IgG4, monoclonal antibody (mAb) to the C-C chemokine receptor type 5 (CCR5)
15812843|NCT04343638|Device|conventional nociception control|While Intraoperative opioid will be administered by conventional clinical practice in control arm.
15812844|NCT04343638|Device|ANI monitor guided nociception control|The intraoperative opioid will be administered by maintaining the 4-minute moving average of ANI ≥50 in ANI-monitor guided nociception control arm.
15812845|NCT04343625|Behavioral|Modified yoga class|Modified yoga was used to see if it would improve pain, fatigue, depression and anxiety, as well as improve sleep quality.
15812846|NCT04343612|Device|Transcranial Direct Current Stimulation|Subjects received a micro-current through their scalp to induce cortical and subcortical changes
15812847|NCT04343599|Other|Hypopressive exercises|The first two sessions will have as objective the correct and effective learning of the hypopressive technique. The rest of the sessions will be dedicated to the realization of an exercise protocol based on a progression of postures from standing to supine. Diaphragmatic apneas of approximately 7 seconds will be performed, alternating each apnea with three breaths.
15812848|NCT04343586|Device|Blue light phototherapy|Phototherapy- Wavelength: 417±15 nm
15812853|NCT04343547|Drug|DWP16001|Tablets, Oral, once daily single dose
15812854|NCT04343547|Drug|DWC202001+DWC202002|Tablets, Oral, multiple doses of DWC202001 and DWC202002 in combination
15812855|NCT04343547|Drug|DWP16001+DWC202001+DWC202002|Tablets, Oral, DWP16001 , DWC202001 and DWC202002 in combination
15812856|NCT04343521|Biological|Targeted Indoor Residual Spraying (TIRS)|Spraying of insecticide Actellic 300CS will start May-June and extend for 1-2 months. Residents will be asked to temporarily leave the house during treatment and wait 0.5-1 h for the product to dry before re-entering the house. Insecticide application will follow strict protocol developed in CDC-Emory-UADY collaboration.
15812857|NCT04343508|Other|Fortified rice|100 g of rice was fortified with 150 µg vitamin A (Vitamin A palmitate), 0.5 mg vitamin B1 (thiamin mononitrate), 7 mg vitamin B3 (niacin amide), 0.6 mg vitamin B6 (pyrodoxine hydrochloride), 1 µg vitamin B12 (cyanocobalamin), 130 µg folic acid, 4 mg iron (ferric pyrosphosphate), and 6 mg zinc (zinc oxide).
15812858|NCT04343495|Device|Wearable Ultra Violet (UV) and blue-light sensors|Non-blinded
15812859|NCT04343482|Device|wearable vital signs sensor|vital signs monitoring during maternal non-stress testing
15812860|NCT04343469|Procedure|Bariatric Surgery (RYGB or LSG)|Morbidly obese subjects will receive either RYGB or LSG, and the effect of bariatric surgery-induced weight loss on brain inflammation will be assessed
15812861|NCT04343456|Procedure|Salvage surgery with massive debulking|For patients with regorafenib treatment and facing local progression, we remove the tumor with progression and achieve cytoreduction.
15812968|NCT04342507|Other|conservative treatment|lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days.
15812862|NCT04343443|Procedure|Clinical examination centered on congestion|Clinical examination centered on congestion will be performed before discharge from hospital
15812863|NCT04343443|Procedure|Cardio-pulmonary, peritoneal, , jugular and renal venous Doppler ultrasounds|Cardio-pulmonary, peritoneal, , jugular and renal venous Doppler ultrasounds will be performed before discharge from hospital
15812864|NCT04343443|Procedure|Biological: Blood sample retrieved for biological assessment and biobanking|Blood sample collection will be performed before discharge from hospital
15812865|NCT04343443|Procedure|Telephone interview|Telephone interview will be performed at 3, 12 months and 24 months after discharge from hospital
15812866|NCT04343430|Procedure|Clinical examination centered on congestion|Clinical examination centered on congestion will be performed before discharge from hospital
15812867|NCT04343430|Procedure|Cardio-pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds|Cardio-pulmonary, peritoneal, , jugular and renal venous Doppler ultrasounds will be performed before discharge from hospital
15812868|NCT04343430|Procedure|Biological: Blood sample retrieved for biological assessment and biobanking|Blood sample collection will be performed before discharge from hospital
15812869|NCT04343430|Procedure|Telephone interview|Telephone interview will be performed at 3, 12 months and 24 months after discharge from Hospital
15812870|NCT04343391|Behavioral|Brief transdiagnostic cognitive-behavioral therapy|Time-limited transdiagnostic evidence-based psychological treatment
15812871|NCT04343391|Drug|Pharmacological treatment|Treatment as usual in PC
15812872|NCT04343365|Other|Evolutionary Tumor Board (ETB)|The ETB consists of evolutionary biologists, mathematicians, research scientists, statisticians,data scientists, radiologists, pathologists, oncologists (surgical, radiation, medical, and pediatric), and clinical trial coordinators.The ETB will generate hypotheses, mathematical models, and experiments from the discussion towards further integration of evolutionary ideas towards therapeutic strategies for participants. The ETB will collect data through a chart review regarding adherence and results of ETB recommendation
15812873|NCT04343352|Other|implementation of mobile epilepsy training program|"Mobile epilepsy training program will be applied to the application group for 3 months.
~The mobile epilepsy training program developed within the scope of the thesis will be introduced to the parents in the application group and the participants will be uploaded to their phones via computer, and the use of the program will be taught in practice. In addition, the participants in the application group will be informed that the mobile epilepsy training program is not open to everyone during the research process, only the application group can use it. After the work is completed, the mobile application control group will be installed on the phones of the parents via computer, their application will be taught and applied."
15812874|NCT04343326|Procedure|perform corneal collagen cross linking accelerated and delivery of systemic oxygen|CXL is performed using an accelerated protocol (9 mW/ CM2 for 10 minutes) in addition to the delivery of systemic oxygen with a rate of 5 liters/min through a nasal mask for 10 minutes during UV-A ablation
15812875|NCT04343326|Procedure|perform corneal collagen cross linking accelerated and without additional oxygen therapy|corneal collagen cross linking with accelerated protocol without additional oxygen therapy
15812876|NCT04343326|Procedure|perform Conventiona corneal collagen cross linking|Conventional CXL using 30 mW/CM2 UV-A ablation for 30 minutes
15812877|NCT04343313|Device|Half Moon TMVr System|The Half Moon Transcatheter Mitral Valve Repair (TMVr) System is designed for transfemoral access and transseptal delivery of a self-expanding implant that restores competency in a regurgitant mitral valve.
15812878|NCT04343300|Other|Pilates|Intervention of12 weeks of Pilates
15812879|NCT04343300|Other|exercise without Pilates|exercise without Pilates
15812882|NCT04343274|Drug|Tozuleristide|
15812883|NCT04343261|Biological|Convalescent Plasma|treatment with 2 Units of convalescent plasma
15812884|NCT04343248|Drug|Nitazoxanide|Nitazoxanide 600 mg administered orally twice daily for six weeks
15812885|NCT04343248|Drug|Placebo|Placebo administered orally twice daily for six weeks
15812886|NCT04343248|Dietary Supplement|Vitamin Super B-Complex|Vitamin Super B-Complex administered orally twice daily to maintain the blind
15812887|NCT04343235|Drug|furosemide|five day course of furosemide 20mg QD
15812888|NCT04343235|Drug|labetalol|400mg labetalol BID
15812889|NCT04343222|Drug|Bromfenac|An NSAID used to treat eye pain and swelling
15812890|NCT04343222|Drug|Artificial tears|eye drops to lubricate the eye and maintain moisture
15812891|NCT04343209|Diagnostic Test|Myocardial Perfusion Imaging Study|Evaluation of myocardial perfusion via PET imaging agent
15812892|NCT04343209|Drug|AMMONIA N-13 37.5 mCi in 1 mL INTRAVENOUS INJECTION [Ammonia N 13]|Cardiac PET imaging agent
15812893|NCT04343196|Radiation|Diagnostic Angiography (DSA or DVA based on randomization result)|After radial/brachial/femoral artery puncture using Seldinger technique, the investigators first position a pigtail catheter above the level of the renal arteries. With Siemens Artis Zee Pure DSA machine the examiner will use a postero-anterior X-ray view for the first image, which is an aortography of some part of the iliac system. Then, the catheter will be repositioned to the aortic bifurcation and 15-18 mL contrast media (CM) with 9-10 mL/s flow for the ilio-femoral region will be injected. All of the following image series will be made from this catheter position, with a 9 mL/s flow rate. In cases for when the recorded image series will be inconclusive, image series with left/right oblique position will be recorded. All femoro-popliteal images will be recorded with 10-16 ml CM and crural regions with 12-22mml. DSA images will be calculated from all series on a dedicated Syngo workstation and used for diagnosis. DVA images will be calculated by the Kinepict Medical Imaging Tool
15812894|NCT04343183|Device|Hyperbaric Oxygen Therapy|Hyperbaric Oxygen Therapy delivered at a specific uniformed pressure and duration.
15812895|NCT04343170|Drug|Placebo|Patients of this group received placebo treatment consisted of two subcutaneous injections of 1 mL saline and an oral placebo
15812896|NCT04343170|Drug|ferric carboxymaltose , α erythropoietin, vitamin B12, oral folic acid|Patients of this group received Combination treatment consisted of a slow (30 min) intravenous infusion of 20 mg/kg ferric carboxymaltose (maximum of 1000 mg), 40 000 U subcutaneous α erythropoietin,1 mg subcutaneous vitamin B12(, and 5 mg oral folic acid (acidum folicum)
15814551|NCT04329494|Drug|Leucovorin|Given IV
15812897|NCT04343157|Radiation|Cognitive Sparing Brain Stereotactic Radiosurgery (SRS)|In this proposal, the investigators introduce advanced diffusion and volumetric imaging techniques along with innovative, automated image parcellation methods to identify critical brain regions, incorporate into cognitive-sparing SRS, and analyze biomarkers of radiation response. This work will advance the investigators' understanding of neurocognitive changes after brain SRS and help create interventions that preserve cognitive-function in brain metastases patients.
15812898|NCT04343144|Drug|Nivolumab Injection|Treatment consists of an infusion of OPDIVO® 3mg/kg on day 1 (D1).
15812899|NCT04343131|Behavioral|Dietary intervention|Crossover dietary manipulation using three different types of diet for 7 days each
15812900|NCT04343118|Procedure|Hardware Removal|elective removal of plate osteosynthesis at the clavicle
15812901|NCT04343105|Procedure|pecto-intercostal plane block|under ultrasound guidance, pecto-intercostal plane block will be performed between 3rd and 4th rib 2 cm lateral to sternal border in supine position at the interfascial plane between pectoralis major muscle and intercostal muscles
15812902|NCT04343092|Drug|Ivermectin (IVM)|Ivermectin 0.2 mg /kg (single dose at once =2 tablets of 6mg/weekly
15812903|NCT04343079|Diagnostic Test|PET CT|measurement of surgical margins during lumpectomy
15812904|NCT04343066|Device|Implant insertion|"In both groups, the implants will be placed using a two-stage surgical approach at the crestal level in previously horizontally augmented bony sites.
~A final crown will be placed (screw-retained on multiunit abutment) between 3- and 4-months post-implant placement.
~Random allocation of implant type per site will be done by the sealed envelope method.
~Follow-up measurements will be done at 6 months and 1-year post-loading. The measurements are done by a blinded investigator. Before starting the study, the examiner will be trained in a calibration process.
~Exam sheets are kept confidential and anonymous. Inclusion criteria are: patient aged 20 to 65, no systematic contraindication for implant surgery, smoking < 10 cigarettes, previous horizontal bone augmentation, FMBS <20% and FMPS < 20%. Exclusion criteria are: general contraindication for implant surgery, pregnant/lactating women, uncontrolled diabetics, patients not willing to sign the consent form, active periodontitis."
15812905|NCT04343053|Other|SARS-Cov-2 infection|blood sample withdrawal
15812906|NCT04343040|Dietary Supplement|carbohydrate supplement (Preload™)|carbohydrate supplement (Preload™) will be administered 4-hours prior to bariatric surgery (experimental treatment) Preload™ is a neutral-tasting carbohydrate loading drink mix specifically designed for use before elective surgery. Preload is presented in 50g pre-measured sachets which when added to water (400ml) produces a solution with low osmolality.
15812907|NCT04343040|Procedure|6 hours of preoperative fasting|Standard of care. In this group, patients continue the standard of care treatment before surgery with fasting recommended 6 hours before surgery.
15812908|NCT04343027|Behavioral|Review|Physicians will review patient-reported outcome measurements with their patients during office visits.
15812909|NCT04343014|Device|Tongue Root Retractor|Fibroptic endutracheal intubation will be performed with tongue root retractor.
15812910|NCT04343014|Device|Conventional Fibroscope|Fibroptic endutracheal intubation will be performed in conventional way.
15812911|NCT04343001|Drug|Aspirin|Aspirin 150mg
15812912|NCT04343001|Drug|Losartan|Losartan 100mg
15812913|NCT04343001|Drug|Simvastatin|Simvastatin 80mg
15812914|NCT04342988|Drug|Cequa|The effect of Cequa treatment on the accuracy of pre-operative biometry and on corneal higher-order aberrations (HOAs) in cataract patients who have signs of dry eye disease.
15812915|NCT04342975|Drug|Nicotinamide Riboside + Pterostilbene|It will be administered a total of 1000 mg/day of NR and 200 mg/day of Ptero in a regimen of 4 capsules of Basis™ (each capsule 125 mg of NR and 25 mg of Ptero) 2 times a day by mouth for 2 weeks before surgery and 6 weeks after surgery. Each intake has to be apart from each other by, at least, 6 hours of interval.
15812916|NCT04342975|Drug|Placebo|The correspondent placebo will be administered in a regimen of 4 capsules 2 times a day by mouth for 2 weeks before surgery and 6 weeks after surgery. Each intake has to be apart from each other by, at least, 6 hours of interval.
15812917|NCT04342962|Drug|tagraxofusp|Tagraxofusp is provided as an intravenous (IV) injectable and administered as a 15-minute IV infusion. Cycle 1 will include a 2-day dosing period for the first 3 enrolled patients (Days 1-2), a 2-day plus an optional 3rd day for patients 4-6 (Days 1-2 + Day 3 if patient meets criteria for continued dosing) and a 3-day dosing period for patients 7 and beyond (Days 1-3). Cycle 2 and beyond will include a 5-day dosing period for all patients (Days 1-5). In all cycles and schedules, dose delays up to Day 10 of each cycle will be allowed for resolution of toxicities.
15812918|NCT04342949|Behavioral|quality of life|To observe the difference of quality of life
15812919|NCT04342936|Drug|Camrelizumab|A humanized monoclonal immunoglobulin
15812920|NCT04342936|Drug|Investigator's choice of Chemotherapy|"Participants will receive one of the following chemotherapies for up to 6 cycles:
~Gemox: Gemcitabine and Oxaliplatin； IGEV: Ifosfamide, Gemcitabine, Vinorelbine, and Prednisolone； DHAP: Dexamethasone, high-dose Cytarabine (Ara-C) and Cisplatin."
15812921|NCT04342923|Other|No intervention|Blood analysis
15812922|NCT04342910|Drug|camrelizumab|200 mg intravenous (IV) camrelizumab on Day 1 and Day 15 of each 28-day cycle.
15812923|NCT04342910|Drug|Apatinib Mesylate|250 mg qd
15812924|NCT04342910|Drug|Paclitaxel|80 mg/m^2 administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.
15812925|NCT04342910|Drug|Irinotecan|180 mg/m^2 administered as IV infusion on Days 1, and 15 of each 28-day cycle.
15812926|NCT04342897|Drug|LY3127804|Administered IV
15812927|NCT04342897|Drug|Placebo|Administered IV
15812928|NCT04342871|Behavioral|Fam-CT|Customized communication guidance to help parents with cancer talk about their cancer with their children.
15812929|NCT04342858|Drug|Fluoride Varnish|Duraphat varnish®, Colgate-Palmolive (UK) Ltd., Guildford, Surrey, UK
15812930|NCT04342858|Drug|Fluoride Varnish with tricalcium phosphate|Clinpro white varnishTM, 3M ESPE, St Paul, MN, USA
15812931|NCT04342858|Other|Oral health education|Standard oral hygiene instructions every 3 months
15812932|NCT04342845|Behavioral|Experimental: Motivational interviewing Placebo Comparator: Traditional lectures|Patients in the intervention group (n=117) received a four-session patient empowerment program in small groups over one month by trained nurses and doctors. he control group received traditional lectures that consisted solely of conveying healthcare information to patients.
15812933|NCT04342832|Procedure|Cryoballoon ablation|If a patient is randomized to early invasive treatment, the ablation is performed within 3 months by an experienced cardiac electrophysiologist using CE-certified equipment. Via the femoral vein a guiding catheter is advanced through the inferior vena cava to the right atrium and into the left atrium via transseptal puncture. Then, the cryoballoon is advanced, inflated, and placed against one of the four PVs. PV occlusion is assessed by selective contrast injection. When adequate PV antral seal is confirmed, ablation of the tissue in contact with the balloon is performed using pressurized liquid nitrous oxide. The cold inflated balloon thus creates circular lesions around the PV. The balloon and tissue interface are then allowed to reach normal temperatures. Depending on local practice, the freeze-thaw cycle may be repeated twice. Electrical isolation is assessed and when it is confirmed, the next PV is treated in the same way. The procedure ends when all PV's are isolated.
15812934|NCT04342819|Drug|SGLT2 inhibitor|Sodium-Glucose Like Transporter 2 Inhibitor
15812935|NCT04342793|Drug|Placebo oral tablet|Placebo
15812936|NCT04342793|Drug|ALS-L1023 1,200mg|ALS-L1023
15812937|NCT04342793|Drug|ALS-L1023 1,800mg|ALS-L1023
15812938|NCT04342767|Device|EZ Debride®|EZ Debride ® is intended for the mechanical debridement of topical wounds including partial and full thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, surgical wounds (donor sites/grafts, post Mohs' surgery, post-laser surgery, podiatric, wound dehiscence) trauma wounds (abrasions, lacerations, second-degree burns and skin tears), draining wounds and tunnelled /undermined wounds.
15812939|NCT04342754|Device|Deep Brain Stimulation (DBS)|The device will be ON
15812940|NCT04342754|Device|Sham Stimulation|The device will be OFF
15812941|NCT04342741|Device|Foley catheter cervical ripening|Participants were assessed when labour was established or the following morning.
15812942|NCT04342728|Dietary Supplement|Ascorbic Acid|Readily available marketed open label ascorbic acid
15812943|NCT04342728|Dietary Supplement|Zinc Gluconate|Readily available marketed open label zinc gluconate
15812944|NCT04342728|Dietary Supplement|Ascorbic Acid and Zinc Gluconate|Readily available marketed open label ascorbic acid and zinc gluconate
15812945|NCT04342728|Other|Standard of Care|Readily available prescribed medications/ supplements- None study supplements
15812946|NCT04342715|Drug|Sodium stibogluconate / paramomycin|Treatment with Sodium stibogluconate / paramomycin
15812947|NCT04342689|Drug|Dietary Supplement containing resistant starch|Two tablespoons (~ 20 grams) to be taken twice daily for 14 days (start with 2 tablespoons once daily for three days, followed by twice daily on days 4 through 14)
15812948|NCT04342689|Dietary Supplement|Placebo Starch|Two tablespoons (~ 20 grams) to be taken twice daily for 14 days (start with 2 tablespoons once daily for three days, followed by twice daily on days 4 through 14)
15812949|NCT04342676|Device|k ras|K ras
15812950|NCT04342676|Drug|Panitumumab|vectibex in stage iv
15812951|NCT04342663|Drug|Fluvoxamine|Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 300mg per day (3 capsules per day) as tolerated.
15812952|NCT04342663|Drug|Placebo|Randomized to either fluvoxamine or placebo for approximately 15 days. Will take up to 3 capsules per day as tolerated.
15812953|NCT04342650|Drug|Chloroquine Diphosphate|150mg tablets Note: Tablets used in the study were Chloroquine Diphosphate (produced by Farmanguinhos/Fiocruz), and the dosing stated in the clinicaltrials.gov refers to chloroquine base (in mg).
15812954|NCT04342650|Drug|Placebo oral tablet|150mg placebo tablets
15812955|NCT04342637|Other|Practice details|Physicians will report details of their endoscopy practice through answering the questions of the questionnaire
15812956|NCT04342624|Dietary Supplement|Cinnamon|Cinnamon supplement
15812957|NCT04342624|Other|Placebo|Placebo
15812958|NCT04342611|Behavioral|Therapeutic Alliance|The intervention will consist of a primary component - an educational intervention for oncologists, and a secondary component - an informational handout for patients. The intervention's conceptual framework is the self-determination theory (SDT) of health behavior change. Oncologists will meet with a standardized patient instructor (SPI) for 2 in-office educational sessions: a 60-minute training session and a 45-minute booster session. At session 1, the SPIs show them a 15-30-minute DVD created by the research team. The key module themes and content for the DVD will be determined by our conceptual model of the TA in Latino advanced cancer patients. In the remaining time, the SPIs will engage the oncologist in role-play exercises. Oncologists will complete a 45-minute reinforcement session 1 month later, which uses a similar format.
15812959|NCT04342598|Other|Serum Vitamin D|Primary exposure assessed will be serum vitamin D (25(OH)D). Diet will also be assessed via Food Frequency Questionnaire.
15812960|NCT04342585|Drug|Micronised vaginal progesterone|A diary will be given to participants to ensure compliance.
15812961|NCT04342585|Device|Vaginal pessary|The internal diameter size will be decided based on the clinical assessment of the cervix.
15812962|NCT04342572|Drug|Melphalan|-The drug is commerically available
15812963|NCT04342559|Other|Belamy (vaginal moisturizer)|"The conformity of the product use by the research participants will be verified through the filling of the product use diary by the research participants and also by the accounting of the tubes not used in T22.
~Interdiction and Restriction
~Keep the test product tightly closed, protected from heat, moisture and out of the reach of children;
~Do not apply any other product to the genital area. Only the use of soap normally used for hygiene will be allowed;
~Do not change genital / vaginal hygiene habits;
~Not having sexual intercourse in the 48 hours (2 days) before the research visits;
~Do not perform a hygienic shower in the genital region within 24 hours (1 day) prior to the research visits;
~Do not perform gynecological / intimate showers during the study period"
15812964|NCT04342546|Device|NovaGray RILA Breast® test|The test consists of a blood sample of 2x4 mL. This test will be performed within 15 days of surgery, 12 months after the end of radiotherapy and within 15 days of starting chemotherapy in the case of neoadjuvant chemotherapy.
15812965|NCT04342533|Procedure|Thulium fiber laser enucleation of the prostate|enucleation of the BPH according to standard procedure protocol
15812966|NCT04342533|Procedure|Holmium laser enucleation of the prostate|enucleation of the BPH according to standard procedure protocol
15812967|NCT04342520|Other|Dyads Patient / caregiver|adult patient / caregiver couples, patient are 55 years of age or older and have Alzheimer's disease or a related disease
15813091|NCT04341454|Drug|DWP14012 Y mg|DWP14012 Y mg, tablet, orally, twice daily for 2 weeks
15812969|NCT04342507|Dietary Supplement|probiotics|use specific probiotics in addiction to conservative treatment to modify the intestinal microbiome to ameliorate the clinical course of adults chalazia by re-establishing intestinal and immune homeostasis
15812970|NCT04342494|Behavioral|Enhanced Feedback + Standard Feedback|"Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.
~Enhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback."
15812971|NCT04342494|Device|Headspace app + Standard Feedback|"Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.
~Headspace is an app designed to train the user in mindfulness practices."
15812972|NCT04342494|Device|Headspace app + Enhanced Feedback + Standard Feedback|"Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.
~Enhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.
~Headspace is an app designed to train the user in mindfulness practices."
15812973|NCT04342494|Device|SilverCloud + Standard Feedback|"Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.
~Silvercloud is an app designed to deliver cognitive behavioral therapy."
15812974|NCT04342494|Device|SilverCloud app +Enhanced Feedback +Standard Feedback|"Standard Feedback (SF) All participants will receive the standard feedback that is standard feedback from the activity trackers. Feedback includes activity level, heart rate, and progress toward daily activity goals on the device itself.
~Enhanced Feedback (EF) Participants randomized to receive enhanced feedback will receive this feedback from the MyDataHelps study app. This includes varying types of text and visual feedback based on data collected through the app. Feedback will be displayed to participants on a dashboard in the app or delivered via pop-up notifications. Participants will receive a combination of text and visual feedback.
~Silvercloud is an app designed to deliver cognitive behavioral therapy."
15812975|NCT04342481|Other|Educational Screening tool|Educational Screening tool
15812976|NCT04342468|Other|non-interventional|No intervention
15812977|NCT04342455|Other|double-low scanning|a CT angiography protocol with low radiation and contrast agent exposure
15812978|NCT04342429|Radiation|Proton-beam Therapy for Small Cell Lung Cancer|The goal of intensity-modulated proton therapy (IMPT) is to deliver radiation to the tumor while minimizing exposure to surrounding normal tissues.
15812979|NCT04342416|Behavioral|Visiospatial Interference|Behavioral: Brief cognitive intervention. A one-session intervention with a researcher including a simple cognitive task (a memory cue and 25 minutes of Tetris game play with mental rotation) with instructions to engage in the task self-guided in the subsequent weeks.
15812980|NCT04342403|Diagnostic Test|Quality of Life|Quality of life instruments including King's Sarcoidosis Questionnaire (KSQ) and Sarcoidosis Assessment Tool (SAT)
15812981|NCT04342390|Other|High-Intensity Interval Training (HIIT)|The exercise we are studying is called high-intensity interval training, or HIIT. Participants in the exercise group will participate in the exercise program. Each exercise session will last up to 1 hour. All exercise sessions will be directed and monitored by an experienced exercise trainer or exercise physiologist.
15812982|NCT04342377|Diagnostic Test|Selective Targeted Sampling|Mediastinal lymph nodes are assessed with the CLNS, and only those appearing malignant with the score are biopsied. Triple Normal lymph nodes (normal appearing on PET, CT and EBUS) are not biopsied.
15812983|NCT04342377|Diagnostic Test|Systematic Sampling|All examined mediastinal lymph nodes are biopsied, regardless of whether they appear normal during PET, CT and EBUS.
15812984|NCT04342364|Other|Vitrification via slush nitrogen|oocytes will be vitrified using slush nitrogen
15812985|NCT04342364|Other|Vitrification via liquid nitrogen|oocytes will be vitrified using liquid nitrogen which is currently routine practice
15812986|NCT04342351|Drug|sacubitril/valsartan|sacubitril/valsartan will be applied from 25mg/b.i.d for 1-2 weeks,50mg b.i.d for 2 weeks, to target dosage 100mg b.i.d for 3 months unless severe safety outcome occurs
15812987|NCT04342351|Drug|perindopril|Drug: perindopril will be applied from 2mg for q.d for 1-2 weeks, 4mg q.d 2 weeks, to target dosage 8mg q.d for 3 months unless severe safety outcome occur
15812988|NCT04342351|Other|Cardiopulmonary Exercise Test|All patients will undergo a first CPET prior to initiation of treatment, a second one after 3 months, and a third one after 6 months of treatment.
15812989|NCT04342351|Other|Echocardiogram|An echocardiogram (ultrasound of the heart) will be performed prior to initiation of treatment and then again 3 months, 6 months later.
15812990|NCT04342325|Biological|infusion of ADR-001 (Mesenchymal stem cell)|Once or twice with two week interval at a dose of 100 x 10 ^ 6 cells.
15812991|NCT04342312|Procedure|Pulmonary vein isolation|Participation in this study does not influence the choice of ablation technique. Usually, cryoballoon ablation is chosen for patients with paroxysmal AF and no previous ablations. Radiofrequency ablation is often used for redo procedures or for patients with persistent AF. Hybrid ablations are most applied in persistent AF patients. However, physicians may deviate from these standard approaches for a variety of reasons, including personal experience or preference.
15812992|NCT04342286|Genetic|Organoid culture|Organoid culture
15812993|NCT04342273|Drug|KW-6356|KW-6356 will be administered once daily as therapeutic at Day 1 through Day 7
15812994|NCT04342273|Drug|KW-6356|KW-6356 will be administered once daily as supratherapeutic dose at Day 1 through Day 7
15812995|NCT04342273|Drug|Placebo|Placebo will be administered once daily at Day 1 through Day 7
15814552|NCT04329494|Drug|Oxaliplatin|Given via PIPAC
15812996|NCT04342273|Drug|Moxifloxacin|Placebo will be administered once daily at Day 1 through Day 6, followed by Moxifloxacin once daily at Day 7.
15812997|NCT04342260|Other|Active Monitoring|The participants randomized to active symptom monitoring will have alerts sent to their clinicians when their PRO symptom scores exceed baseline postoperative scores (when discharge day scores are available) by 2 points or more, or when 'severe' or 'very severe' symptoms are reported.
15812998|NCT04342260|Other|Passive Monitoring|Participants randomized to the passive PRO monitoring arm will complete the same PROs as participants in the active monitoring arm, but will not have alerts sent to their clinician.
15812999|NCT04342247|Drug|external testosteron|external testosteron
15813000|NCT04342234|Other|data collection of palatal casts and palatal images of cleft patients routinely treated at the institution|data collection of palatal casts and palatal images of cleft patients, using routinely taken intraoral/palatal photographs and palatal casts of infants with cleft lip and palate deformity
15813001|NCT04342221|Drug|Hydroxychloroquine Sulfate|Hydroxychloroquine Sulfate is an anti-malarial and anti-rheumatic drug and seems to be a potential candidate for the treatment of COVID-19 since it is able to block virus infection by increasing the endosomal pH, required for virus/cell fusion, it affects the activation of p38 mitogen-activated protein kinase (MAPK), involved in the replication of HCoV-229E and can interfere with the terminal glycosylation of ACE2, thus inhibiting SARS-CoV-2 infection.
15813002|NCT04342221|Drug|Placebo|Placebo capsules
15813003|NCT04342195|Procedure|Blood draw|Participants will have approximately 45 ml of whole blood drawn (3 Tablespoons) drawn at the study visit.
15813004|NCT04342182|Biological|Convalescent plasma|"Infusion of plasma retrieved from donors with a history of PCR proven symptomatic COVID.
~Plasma will be administered according to the Erasmus MC KIS protocol regarding the use of blood products"
15813005|NCT04342169|Drug|Hydroxychloroquine|HCQ 400mg po BID x 1 day, then 200mg po BID x 4 days
15813006|NCT04342169|Drug|Placebo oral tablet|Placebo to be taken on the same schedule as HCQ.
15813007|NCT04342156|Drug|Hydroxychloroquine Sulfate 200 milligram (mg) Tab|Oral tablet of Hydroxychloroquine sulfate
15813008|NCT04342143|Device|Blood pressure and ultrasound assessment|No intervention. Participants will undertake an overnight fast prior to each assessment (only water is allowed to be consumed prior to the assessment).Participants will be asked to visit the lab on four separate occasions; the first two sessions will involve triplicated measures of carotid-femoral PWV (cfPWV), brachial-femoral PWV (bfPWV), brachial-ankle PWV (baPWV), femoral-ankle PWV (faPWV) and TT by the Vicorder in both seated and supine position. During the third and fourth sessions individuals will be randomised into either a supine or seated position. A 3 lead ECG will be attached and ultrasound video clips will be taken at the carotid, brachial, femoral and posterior tibial artery on both the symptomatic and asymptomatic sides to look at stiffness and blood velocity. Following this, the Vicorder will be used to look at cfPWV, bfPWV, baPWV, faPWV and TT on both sides.
15813009|NCT04342130|Drug|Morphine|30 mg oral tablet
15813010|NCT04342117|Drug|duvelisib|25 mg BID, 15 mg BID
15813011|NCT04342117|Drug|PI3K inhibitor|FDA approved PI3K inhibitors
15813012|NCT04342104|Other|Monitoring for aggravation|"Monitor patients on CPAP or NIV and analyzing possible variables that may predict failure, namely:
~lymphopenia
~thrombocytopenia
~CRP
~ferritin
~LDH
~troponin I
~NT-ProBNP
~Liver enzymes
~D-dimers
~radiologic aggravation  1 day and 1 week after starting NIV or CPAP"
15813013|NCT04342104|Other|Evaluate HACOR score effectivity in this patients|Apply the HACOR score after starting NIV and CPAP and later verify if it was effective in predicting NIV/CPAP failure
15813014|NCT04342091|Device|SOL Nova Device|A SOL Nova Device (brand) is tattoo machine will be used to stimulate hair regrowth.
15813015|NCT04342078|Dietary Supplement|Vitamin D|To investigate the effect of one year vitamin D supplementation in preterm born adults (4000 IU = 100 micrograms a day if serum concentration is < 30 nmol/l, 2000 IU = 50 micrograms a day if 30-50 nmol/l and 1000 IU = 25 micrograms a day if > 50-80 nmol/l, and no additional supplement if > 80 nmol/l) on health outcomes (bones, teeth, muscles, heart, lungs) . The target level of vitamin D concentration by every 4 months interval is 80 - 120 nmol/l .(Preterm Adult group)
15813016|NCT04342065|Drug|Celecoxib capsules|received celecoxib 200 mg 2 hours preoperative and the same dose 6 hours postoperative.
15813017|NCT04342065|Drug|Pregabalin 150mg|received Pregabalin 150mg 2 hours preoperative and the same dose 6 hours postoperative.
15813018|NCT04342039|Drug|Budesonide Nasal|budesonide 64 mcg/spray; 2 sprays each nostril once daily on days as indicated in the timeline
15813019|NCT04342039|Other|Placebo|2 sprays each nostril daily on days as indicated in the timeline
15813020|NCT04342026|Other|Measure of the exposure of parent of male with /without cryptorchidism to endocrine disruptors|Measure of the exposure of parent of patient with/without cryptorchidism to endocrine disruptors (job exposure, during pregnancy)
15813021|NCT04342013|Other|Electronic Clinical Decision Support Application|Robust, real-time medication-related clinical decision support application for use in the operating room. The application is fully integrated with existing clinical systems. It provides visual alerts for medication errors and adverse medication events at the point-of-care.
15813022|NCT04342000|Other|Movement education workshop|"30 minutes total:
~10 minutes sedentary activity (LE injury risk factor and anatomy instruction)
~10 minutes moderate activity (guided discovery of body segment alignment and stability with squat, lunge, plank, jump, and hop technique assessment and corrective feedback)
~10 minutes vigorous activity (practical application of body segment alignment and stability including hopping, jumping, and running activities with technique assessment and corrective feedback)
~For the month following the athlete workshop, prior to the final assessment, subjects will receive periodic text message instructions. These messages will include key facts and takeaways from the workshop, and reminders about correct form."
15813023|NCT04342000|Other|Sham Education Workshop|"30 minutes total:
~10 minute sedentary activity (sleep, nutrition, and hydration instruction)
~10 minutes moderate activity (performance of squat, lunge, plank, jump, and hop activities - no technique assessment or corrective feedback)
~10 minutes vigorous activity (hopping, jumping, and running activities - no technique assessment and corrective feedback)"
15813024|NCT04341987|Behavioral|brief Imagery Rehearsal Therapy|Two-sessions of behaviorally-based imagery rehearsal therapy.
15813025|NCT04341987|Other|Treatment As Usual|may include medication treatment or behavioral treatment for nightmares other than imagery rehearsal therapy
15813026|NCT04341974|Diagnostic Test|Serum creatinine|Will be described: 1) the number of patients actually screened with postoperative serum creatinine and 2) the number of patients actually screened with the same parameter at the long-term after surgery
15813027|NCT04341961|Other|Pomegranate Juice|Drinking 8 oz of pomegranate juice daily for 2 weeks.
15813028|NCT04341948|Device|SPRINT Peripheral Nerve Stimulation (PNS) System|"The SPRINT System delivers mild electrical stimulation to nerves in the affected limb. The SPRINT System includes two small wires (called Leads) that are placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator)."
15813029|NCT04341935|Drug|Linagliptin|5 mg Linagliptin administered by mouth once daily
15813030|NCT04341935|Drug|Insulin regimen|Standard of care insulin regimen as per hospital protocol
15813031|NCT04341922|Behavioral|Internet-delivered cognitive behavior therapy (ICBT) for dysfunctional worry related to the Covid-19 pandemic|The intervention focuses on 1) teaching participants how to discriminate between functional and dysfunctional worry (what are solvable problems vs. what is worry, i.e. unsolvable thoughts?) 2) providing participants with skills to solve functional worry topics (e.g. set time and make a workable plan to be prepared for possible negative outcomes [e.g. becoming unemployed]), 3) helping participants to reduce unhelpful behaviors that may reinforce worry (e.g., limit excessive news consumption, refrain from assurance seeking behaviors), 4) providing participants with skills to approach dysfunctional worry (e.g., not engage in worrisome thoughts, just leave them), and 5) increase the behavioral repertoire (take walks, engage in activities that promote health without putting oneself at risk to become infected).
15813032|NCT04341909|Procedure|ERCP|endoscopic retrograde cholangiopancreatography
15813033|NCT04341896|Other|Caregivers|Individuals who cared for themselves and their transplant recipient before and after kidney donation
15813034|NCT04341896|Other|Non-caregivers|Individuals who donated a kidney as a living donor but did not serve as the primary caregiver for their recipient
15813035|NCT04341883|Drug|anti-PD-1+Albumin-Bound Paclitaxel|"anti-PD-1: 200mg/3w+Albumin-bound paclitaxel: 260 mg/m2/3w.Albumin-bound paclitaxel may be used for up to 6 cycles, and anti-PD-1 for up to 2 years.
~Other Name: Programmed cell death 1 antibody"
15813036|NCT04341870|Drug|Sarilumab|Sarilumab: 400 mg in a 1 hour - I.V. infusion on D1
15813037|NCT04341870|Drug|Azithromycin|Azithromycin: oral administration, 500mg on D1 then 250mg QD on D2 to D5 (total duration 5 days)
15813038|NCT04341870|Drug|Hydroxychloroquine|Hydroxychloroquine: oral administration, 600mg QD (200mg TID) from D1 to D10 (total duration 10 days)
15813039|NCT04341857|Drug|PD-1 Monoclonal Antibody(Sintilimab)|Sintilimab combined with FLOT regimen,Docetaxel#50mg/m2d1,iv infusion for 1 hour#,Oxaliplatin#80mg/m2d1#iv infusion for 2 hours#,Calcium,leucovate#200mg/m2d1#iv infusion# ,Fluorouracil#2600mg/m2,intravenous drip for 24h# Every 14 days is one cycle# Sintilimab#200mg, d1#iv infusion Every 21 days is one cycle.
15813040|NCT04341844|Drug|Methylene Blue|2mg/kg MB diluted with normal saline into total 50 ml volume intravenous administration after induction of anesthesia within one hour.
15813041|NCT04341844|Drug|Placebo|normal saline in total 50 ml volume intravenous administration after induction of anesthesia within one hour.
15813042|NCT04341831|Drug|Teicoplanin|We will be used 200mg Teicoplanin powder for each level of instrument.Hemovac drains will be used in either group. The drains will remain closed for 6 hours post-operatively for teicoplanin powder penetration in a surgical site.
15813043|NCT04341818|Other|Strength Training and Vitamin D monthly|For 4 wks 50.000 IU vitamin D is given as a monthly dose together with daily 400mg of calcium. Both as a supplement, followed by a 10 weeks resistance training (progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the vitamin D and calcium intake remain.
15813044|NCT04341818|Other|Strength Training and Vitamin D daily|For 4 wks 800 IU vitamin D is given as a daily dose together with daily 400mg of calcium. Both as a supplement, followed by a 10 weeks resistance training (progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the vitamin D and calcium intake remain.
15813045|NCT04341818|Other|Strength Training and no Vitamin D|For 4 wks no vitamin D is administered, followed by a 10 weeks resistance training (progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the also no vitamin D is given. Over the whole study period participants get 400 mg calcium/day.
15813046|NCT04341805|Procedure|PrevOmega|The intervention consisted of placing a prosthesis at the umbilical trocar level with subsequent application of AGHO depending on the randomization performed.
15813047|NCT04341805|Procedure|Physiological saline|The intervention consisted of placing a prosthesis at the umbilical trocar level with subsequent application of SSF depending on the randomization performed.
15813048|NCT04341779|Combination Product|Point-of-care viral load testing and tenofovir adherence testing|Point-of-care testing of HIV viral load and tenofovir, and providing same day results to participants
15813049|NCT04341766|Other|No special intervention|No special intervention : Ultrasound data will be collected
15813050|NCT04341753|Other|pulmonary rehabilitation|"the strength' measure of the deltoids, triceps and brachial biceps will be carried out by another technique: the 1-RM technique (with dumbbells);
~- 2 other times, the strength' measure of the deltoids, triceps and brachial biceps will be carried out by handheld dynaometry."
15813051|NCT04341740|Procedure|Bone Marrow Aspirate|bone marrow aspiration
15813052|NCT04341727|Drug|Hydroxychloroquine Sulfate|anti-rheumatic drug (DMARD)
15813053|NCT04341727|Drug|Azithromycin|Antibiotic
15813054|NCT04341727|Drug|Chloroquine Sulfate|Antimalarial
15813055|NCT04341714|Other|Satisfaction evaluation|Assessement of satisfaction of the telephone consultation
15813056|NCT04341701|Procedure|MRI|The procedure to study lung and heart MRI, performed on a 1.5T magnet (Siemens), without any injection or inhalation of contrast agent
15813089|NCT04341454|Drug|DWP14012 X mg|DWP14012 X mg, tablet, orally, once daily for 2 weeks
15814553|NCT04329494|Other|Quality-of-Life Assessment|Ancillary studies
15813057|NCT04341688|Drug|Gargle/Mouthwash|"There will be 50 patients in six study groups. Group A (n=10) patients on 10 ml gargle and nasal lavage using 0.2% Povidone-Iodine (Betadiene®) for 20-30 seconds, thrice daily for 6 days.
~Group B (n=10) patients will be subjected to 10 ml gargle and nasal lavage using 1% Hydrogen peroxide (ActiveOxy®) for 20-30 seconds, thrice daily for 6 days.
~Group C will comprised of (n=10) subjects on 10ml gargle and nasal lavage using Neem extract solution (Azardirachta indica) formulated locally) for 20-30 seconds, thrice daily for 6 days.
~Group D (n=10) patients will use 2% hypertonic saline (Plabottle®) gargle and nasal lavage for a similar time period.
~Group E (n=10) will serve as positive controls. These will be given simple distilled water gargles and nasal lavage for 20-30 seconds, thrice daily for six days Whereas Group F (n=5) will comprise of negative controls, who will not use any gargles or nasal lavage during study period."
15813058|NCT04341675|Drug|Sirolimus|Sirolimus 6mg daily on Day 1 followed by 2mg daily for the next 13 days for a total treatment duration of 14 days or hospital discharge, whatever happens sooner.
15813059|NCT04341675|Drug|Placebo|Matching placebo
15813060|NCT04341662|Behavioral|E-MOTIVE intervention|"The E-MOTIVE intervention consists of three elements: 1) a strategy for early detection of PPH, which allows triggering of the 'first response' treatment bundle; 2) a 'first response' bundle called MOTIVE, based on the WHO guideline recommendations and consisting of uterine Massage, Oxytocic drugs, Tranexamic acid, IV fluids and Examination & Escalation; and 3) an implementation strategy, focusing on simulation-based training, peer-assisted learning, local E-MOTIVE champions, feedback of actionable data to providers, calibrated drape with action line, and MOTIVE emergency kits."
15813061|NCT04341662|Behavioral|Usual care|Health facilities will continue to follow usual care as per the baseline period for the remainder of the intervention phase.
15813062|NCT04341649|Other|Manual Head Massage|Duration 10 minutes.
15813063|NCT04341649|Device|BREO Helmet Massager|Duration 10 minutes.
15813064|NCT04341649|Device|Low Laser Therapy (LLT)|Duration 7 minutes.
15813065|NCT04341649|Device|Sham LLT|Duration 7 minutes.
15813066|NCT04341649|Device|TENS ear stimulation|Duration 7 minutes.
15813067|NCT04341649|Behavioral|Deep and Slow breathing|A full respiratory cycle of 10 seconds with 5 seconds for inspiration and 5 seconds for expiration.
15813068|NCT04341649|Behavioral|Relaxed Reading time|Duration 10 minutes.
15813069|NCT04341636|Radiation|Bitewing X ray|"Each patients will be exposed to 4 horizontal bitewing for posterior teeth ( standard of care ) and 4 vertical bitewing for the same area ( experimental ) . X ray will be taken using a film holder and a steel wire (3mm ) on the film holders. This steel wire will help to adjust for magnification later on. The x ray tube will be in the same distance (4mm from the x ray).
~The bitewing radiographs will be taken with double-packed Ekta speed Plus films on a radiograph machine operating at 0 kilovolt peak and 8 milliampere, having 2.5 aluminium filtration and a 0.860.8 mm focal spot, according to the manufacturer's exposure recommendations, with the parallel technique to obtain an accurate x ray as much as possible . The radiographs will be processed digitally. All the x ray will be taken using the standard protection protocol ."
15813070|NCT04341623|Other|Cetaphil Pro Eczema moisturizer|All 30 patients to receive
15813071|NCT04341623|Behavioral|Electronic interaction|10 patients to electronic surveys about moisturizer use
15813072|NCT04341623|Behavioral|GPSkin|Measuring moisture in the skin
15813073|NCT04341610|Drug|Stem Cell Product|100 million allogeneic adipose-derived mesenchymal stromal cells diluted in 100 ml saline
15813074|NCT04341597|Other|cervical ultrasound|All volunteer patients for whom a cervical ultrasound is indicated will have with a first operator the performing the usual technic, and with a second operator performing the trans perineal technic without being aware of the first measurement.
15813075|NCT04341584|Drug|Anakinra|"Treatment includes the administration of Two IV infusions / day of ANAKINRA KINERET® 200mg (Total 400 mg) at day 1 (D1), D2 and D3, two IV infusions / day of ANAKINRA KINERET® 100mg (Total 200 mg) at day 4 (D4), and one IV infusion of ANAKINRA KINERET® 100mg (Total 100 mg) at day 5 (D5).
~In case of absence of improvement at D4 (absence of clinical improvement AND absence of decrease of CRP level > 50%), 3 supplementary days of treatment at 400 mg/day will be done at D4, D5, D6 followed by a decrease at 200 mg/day at D7 and 100 mg/day at D8 and stop thereafter"
15813076|NCT04341571|Dietary Supplement|Probiotics|Probiotics capsules (lactobacillus acidophilus y bifidobacterium lactis) 400 mg 1 time at day before breakfast and one placebo capsule before dinner during 13 weeks. Homologated to the other intervention.
15813077|NCT04341571|Drug|Metformin|"Metformin capsules, 750 mg, two pere day before breakfast and dinner during 13 weeks.
~Homologated to the other intervention."
15813078|NCT04341558|Other|Family supplemented patient monitoring|Intervention training sessions will last 30 minutes and will be held twice a day over a period of six months. Carers will be welcome to attend as often as they wish. Carers will be given practical training to assess the following vital signs: heart rate, respiratory rate, conscious level (AVPU scale) and arterial oxygen saturation (SpO2) in accordance with trial standard operating procedures. An important component of the training package will be ensuring carers know how to wash their hands before and after contact with their patients. The study team will ensure that handwashing facilities are available on the ward for use by carers. Carers will record vital signs on a basic observation chart every 4 hours after surgery. They will compare results with colour posters displayed throughout each ward, providing guidance on how and when to notify nursing staff of abnormal vital signs.
15813079|NCT04341545|Other|Placebos|Placebo 4 tablets a day for one week.
15813080|NCT04341545|Drug|Letrozole tablets|Letrozole 10mg daily for one week.
15813081|NCT04341519|Behavioral|PTSD|"family members: post-traumatic stress disorder (PTSD) related symptoms assessed by Impact of Event Scale Revised (IES-R) at 90 days
~Patients:
~post-traumatic stress disorder (PTSD) related symptoms assessed by Impact of Event Scale Revised (IES-R) at 90 days"
15813082|NCT04341519|Behavioral|Burnout|Symptoms of burnout as assessed by the Maslash Burnout Inventory
15813083|NCT04341506|Device|Non-contact ECG|A non-contact ECG will be used to detect a patient cardiac electrical activity.
15813084|NCT04341493|Drug|Nitazoxanide 500 MG|Clinical evaluation of patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using this option with two drugs
15813085|NCT04341493|Drug|Hydroxychloroquine|Clinical evaluation of patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using this option with one drug
15813086|NCT04341480|Drug|Chemotherapy|Routine chemotherapy for individual tumor type.
15813092|NCT04341454|Drug|DWP14012 Y mg placebo|DWP14012 Y mg placebo-matching tablet, orally, twice daily for 2 weeks
15813093|NCT04341441|Drug|Hydroxychloroquine - Daily Dosing|"The daily hydroxychloroquine treatment arm will receive a 200 mg oral dose daily following day 1 dose of 400 mg orally once. This dose represents approximately half the standard weight-based dosing recommended for management of autoimmune diseases and therefore less likely to produce side effects than standard of care.
~All treatment groups will receive placebo pills to have the patients take 2 pills a day."
15813094|NCT04341441|Drug|Hydroxychloroquine - Weekly Dosing|"The once weekly randomized treatment arm will receive the proposed dose of hydroxychloroquine for prophylaxis of malaria is 6.5 mg/kg per dose (maximum of 400 mg per dose) administered orally weekly on the same day of each week. This is based on the recommended dose for prophylaxis of malaria
~All treatment groups will receive placebo pills to have the patients take 2 pills a day."
15813095|NCT04341441|Other|Placebo oral tablet|"Participants randomized to this arm will be provided with daily dosing of oral placebo to have the patients take 2 pills a day..
~Participants will receive a monitoring phone call at 4 weeks post study entry to monitor for COVID-19 symptoms and medication side effects. At week 8, participants will provide additional samples of whole blood.
~Additional studies will include serology, inflammatory and other disease associated markers. Clinical data and location of main work area will be collected."
15813096|NCT04341441|Diagnostic Test|Monitoring Visit - Baseline|Face-to-face monitoring visit to obtain monitoring questionnaires to assess for COVID-19 symptoms/diagnosis, adherence and medication side effects, and collect study blood samples. Three (3) blood specimens will be collected from each Participant using the sterile procedure as routine standard of care. A total of five (5) 10 mL tubes of whole blood will be collected at each timepoint.
15813097|NCT04341441|Diagnostic Test|Monitoring Visit - Week 4|Face-to-face monitoring visit to obtain monitoring questionnaires to assess for COVID-19 symptoms/diagnosis, adherence and medication side effects, and collect study blood samples. Three (3) blood specimens will be collected from each Participant using the sterile procedure as routine standard of care. A total of five (5) 10 mL tubes of whole blood will be collected at each timepoint.
15813098|NCT04341441|Diagnostic Test|Monitoring Visit - Week 8|Face-to-face monitoring visit to obtain monitoring questionnaires to assess for COVID-19 symptoms/diagnosis, adherence and medication side effects, and collect study blood samples. Three (3) blood specimens will be collected from each Participant using the sterile procedure as routine standard of care. A total of five (5) 10 mL tubes of whole blood will be collected at each timepoint.
15813099|NCT04341441|Other|Weekly Assessment|Participants will be asked to contact the study team if COVID-19 infection is established at any time during the study. For study weeks 1,2,3,5,6 &7, Participants will receive a monitoring questionnaire to assess for COVID-19 symptoms/diagnosis, adherence and medication side effects. These monitoring visits will be done by telephone and/or electronic encounters (virtual visits, email), whichever method the patient prefers to encourage adherence to the monitoring.
15813100|NCT04341428|Drug|DWP14012 20 mg|DWP14012 20 mg, tablet, orally, once daily for up to 24 weeks
15813101|NCT04341428|Drug|DWP14012 20 mg placebo|DWP14012 20 mg placebo-matching tablet, orally, once daily for up to 24 weeks
15813102|NCT04341428|Drug|Lansoprazole 15 mg|Lansoprazole 15 mg capsule, orally, once daily for up to 24 weeks
15813103|NCT04341428|Drug|Lansoprazole 15 mg Placebo|Lansoprazole 15 mg Placebo capsule, orally, once daily for up to 24 weeks
15813104|NCT04341415|Procedure|Auricular neuromodulation|"The pose is carried out by the principal investigator, alone, without the presence of the nursing staff in the room.
~Ear disinfection and sterile neuromodulation needle placement (service protocol with Chlorhexidine) Placement of 4 semi-permanent Classic needles (SEDATELEC®) on each ear flap at the level of the concha (innervated by the vagus nerve) according to an order and a precise location (4 cardinal points conch), i.e. 8 needles per patient.
~Compress soaked with Oxygenated water on the concha (to stop potential bleeding).
~Placing an opaque dressing on the ear and a non-occlusive Band-Aid"
15813105|NCT04341415|Procedure|Control|"The pose is carried out by the principal investigator, alone, without the presence of the nursing staff in the room.
~Ear disinfection and sterile manipulation without needle placement (service protocol with Chlorhexidine) No needle laying but only sterile disinfection and pressure over the 4 putative locations with the sterile plastic tip (without the needle).
~Compress soaked with Oxygenated water on the concha. Placing an opaque dressing on the ear and a non-occlusive Band-Aid."
15813106|NCT04341402|Drug|Antifungal Nail Gel Study|Daily Application antifungal gel of miconazole 3% and diclofenac sodium 1% and urea 40% to infected nails.
15813107|NCT04341389|Biological|Recombinant novel coronavirus vaccine (Adenovirus type 5 vector)|Intramuscular injection
15813108|NCT04341389|Other|Placebo|Intramuscular injection
15813109|NCT04341376|Behavioral|Enhanced First Connections|Enhanced First Connections is a short-term home visiting program that includes prenatal identification and engagement of women with an adversity or trauma history, and infant and early childhood mental health consultation.
15813110|NCT04341363|Device|Tattoo machine|A SOL Nova Device (brand) tattoo machine will be used to stimulate hair regrowth.
15813111|NCT04341350|Drug|Propofol + analgesic drug|sedation according to a written, standardized Nurse management protocol using at least one sedative drug (propofol) and one analgesic drug. It uses the nurse driven analgesia protocol of each ward involved in the study. It uses a pain assessment score (BPS, VICOMORE, FLACC), local or regional anesthesia, non-opioïd adjuncts (acetaminophen, NSAIDs, nefopam), opioïds (per os opioïds, bolus of sufentanyl followed by continuous infusion if necessary, continuous infusion of remifentanyl
15813112|NCT04341350|Drug|Isoflurane + analgesic drug|sedation by inhalation of halogenated gas (Isoflurane) delivered by the Anesthetic-Conserving Device (ACD) system ANACONDA ™ associated with the administration of a analgesic drug. It uses the nurse driven analgesia protocol of each ward involved in the study. It uses a pain assessment score (BPS, VICOMORE, FLACC), local or regional anesthesia, non-opioïd adjuncts (acetaminophen, NSAIDs, nefopam), opioïds (per os opioïds, bolus of sufentanyl followed by continuous infusion if necessary, continuous infusion of remifentanyl.
15813113|NCT04341337|Other|interview|questionnaire about ethics in surgery
15813114|NCT04341324|Other|It is an observational study.|
15813115|NCT04341311|Drug|Marizomib|- Intravenously initially given every other week over a 28 day course but will go to weekly x 3 and weekly x 4 as the dose levels increase Up to 26 courses.
15813116|NCT04341311|Drug|Panobinostat|- Panobinostat: Oral dosage is given 3 times weekly, every other week over a 28 day course
15813117|NCT04341298|Other|11-point pain scale|Subjects will be asked to rate their headache pain using an 11-point scale, i.e. on an integer scale from 0 to 10 inclusive, with 0 indicating no pain and 10 indicating the worst pain imaginable.
15813118|NCT04341298|Other|Headache diary|Subjects will be asked to record specific information for the first (and all subsequent) severe or very severe migraine headaches that they experience while enrolled in the study.
15813119|NCT04341298|Device|Avulux®|Avulux® device
15813120|NCT04341298|Device|Sham Avulux®|Sham Avulux®
15813121|NCT04341285|Procedure|ECMO Implantation|Insertion of Extracorporal Membrane Oxygenation (ECMO) within 24 hours of referral to an Intensive Care Unit.
15813122|NCT04341272|Device|Intermittent Pneumatic Compression Device (FDA approved)|Compression Device placed on either upper or lower extremity for DVT prophylaxis following surgery
15813123|NCT04341259|Drug|Ipatasertib|Participants will receive a 400-mg Ipatasertib dose (two 200-mg tablets) orally (PO) daily (QD) as described above.
15813124|NCT04341246|Device|LiverMultiscan|The Livermultiscan is a quick, 15 minute contrast free MRI scan that provided metrics to quantify liver health namely fat, iron and fibro-inflammation
15813125|NCT04341220|Device|Transcranial direct current stimulation (tDCS)|Transcranial direct current stimulation is a noninvasive technique of neuronal modulation.
15813126|NCT04341220|Other|Balance exercises|Specific balance exercises, focused on balance, postural control and control of the center of gravity within the support base.
15813127|NCT04341207|Drug|Hydroxychloroquine|Hydroxychloroquine 200 mg 3 times a day for 10 days
15813128|NCT04341207|Drug|Azithromycin|Azithromycin 500 mg on day 1 followed by 250 mg/day for 4 days
15813129|NCT04341194|Behavioral|Parent-driven pain management with skin-to-skin contact|The infant is placed naked (except for a diaper and possibly a hat) on the parents' bare chest.
15813130|NCT04341194|Behavioral|Parent-driven pain management with skin-to-skin contact/breastfeeding/parental singing|Live parental infant-directed lullaby singing is an individually tailored, non-verbal, multisensory, multimodal and affective tool to regulate the infant before, during and after venipuncture. Direct breast-feeding has demonstrated efficacy that is equal to, or greater than, sweet taste interventions in reducing behavioral and physiological responses to pain in full-term infants undergoing venipuncture with no demonstrated adverse outcomes. Direct breast-feeding should be considered the preferred first-line analgesic intervention for painful procedures performed on full-term infants.
15813131|NCT04341181|Drug|Alectinib|Alectinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Alectinib might be expected based on their molecular tumor profile.
15813132|NCT04341181|Drug|Atezolizumab|Atezolizumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Atezolizumab might be expected based on their molecular tumor profile.
15813133|NCT04341181|Drug|Avelumab|Avelumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Avelumab might be expected based on their molecular tumor profile.
15813134|NCT04341181|Drug|Axitinib|Axitinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Axitinib might be expected based on their molecular tumor profile.
15813135|NCT04341181|Drug|Erlotinib|Erlotinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Erlotinib might be expected based on their molecular tumor profile.
15813136|NCT04341181|Drug|Vemurafenib plus Cobimetinib (combination)|Vemurafenib plus Cobimetinib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Vemurafenib plus Cobimetinib might be expected based on their molecular tumor profile.
15813137|NCT04341181|Drug|Trastuzumab plus Pertuzumab (combination)|Trastuzumab plus Pertuzumab treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Trastuzumab plus Pertuzumab might be expected based on their molecular tumor profile.
15813138|NCT04341181|Drug|Trastuzumab emtansine|Trastuzumab emtansine treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Trastuzumab emtansine might be expected based on their molecular tumor profile.
15813139|NCT04341181|Drug|Vismodegib|Vismodegib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Vismodegib might be expected based on their molecular tumor profile.
15813140|NCT04341181|Drug|Niraparib|Niraparib treatment for patients with an advanced solid tumor, multiple myeloma or B cell non-Hodgkin lymphoma, who are not eligible for on-label treatment but for whom anti-tumor activity of Niraparib might be expected based on their molecular tumor profile.
15813141|NCT04341168|Other|this study is non- interventional|this study is non- interventional
15813142|NCT04341155|Drug|Dexamethasone|Patients in experimental arms will receive i.v. dexamethasone 20 mg (4 ampules = 20mL) for 7 days
15813143|NCT04341155|Drug|Placebo|Patients in placebo arms will receive 20 mL normal saline intravenously for 7 days
15813144|NCT04341142|Diagnostic Test|Serological tests will be applied on patients blood sampling|Application of tests on patients' serum
15813145|NCT04341129|Drug|Abbreviated MRI protocol: initial experience with Dotarem® (Gadoterate Meglumine)|To test the diagnostic effectiveness of an abbreviated MRI to a full MRI in the evaluation of breast lesions using Dotarem
15813146|NCT04341116|Drug|TJ003234|patients receive a single infusion
15813147|NCT04341116|Drug|Placebo|patients receive a single infusion
15813149|NCT04341077|Drug|SHR3162|A single oral dose of fluzoparib on Day 1
15813150|NCT04341064|Behavioral|SHINE Intervention|[see arm/group descriptions]
15813629|NCT04337112|Drug|viltolarsen|Intravenous (IV) infusions, weekly, at 80mg/kg, once weekly (approximately every 7 days).
15813151|NCT04341051|Other|Case|Mesure with NIRS regional saturation in patients undergoing popliteal block during vascular surgery for chronic obliterating arteriopathy (IIa to III Fontaine Classification)
15813152|NCT04341038|Drug|Tacrolimus|the necessary dose to obtain blood levels of 8-10 ng / ml
15813153|NCT04341038|Drug|Methylprednisolone|120mg of methylprednisolone daily for 3 consecutive days
15813154|NCT04341025|Behavioral|Mindfulness based psychosexual therapy ( MBPST)|The group treatment sessions will integrate empirically supported elements of psychoeduation, cognitive behavioural therapy, and mindfulness skills. Each of the six sessions will follow the well-defined manualized treatment protocol. The treatment is adapted from the study team's previous mindfulness-based treatment group (H15-03172), for situational ED which has been shown to be effective. Participants will be provided with handouts and asked to complete approximately 10-60 minutes/day of at-home practice/skills, which may include reading material, mindfulness exercises, and/or behavioural exercises between sessions. During the 2 follow-up sessions, participants will be invited to share their experience since the conclusion of group, ask questions, and participate in troubleshooting.
15813155|NCT04341012|Diagnostic Test|Collection of breath sample|Analysis of volatile organic compounds in breath
15813156|NCT04340999|Diagnostic Test|Nerve conduction studies and Quantitative EMG ( MUNE and IPA)|"Nerve Conduction Studies: Electrophysiological method that tests the presence/absence of peripheral neuropathy.
~MUNE: Electrophysiological technique that assess number of motor units. IPA: Electrophysiological method that assess interference pattern and hence, borderline cases of neuropathy/ myopathy"
15813157|NCT04340973|Device|Transcranial Direct Current Stimulation|Subjects received a micro-current through their scalp to induce cortical and subcortical changes
15813158|NCT04340960|Other|Home Monitoring|Patients in this group will receive home monitoring for NIBP (non-invasive blood pressure), SPO2 (pulse oximetry), ECG (electrocardiogram), and pain scores. These will be monitored 4 times a day for 2 weeks following surgery.
15813159|NCT04340947|Other|Very low nicotine cigarettes|Participants will be randomized to smoke menthol and non-menthol flavored very low nicotine cigarettes in their home environment for 7 days and in the laboratory
15813160|NCT04340934|Device|REZUM system|Rezūm is a system uses water steam energy to remove the particular part of the prostate that enlarges and causes symptoms due to BPH. Rezum involves a radiofrequency (RF) generator system and an endoscopic device that is introduced into the body via the urethra.
15813161|NCT04340921|Biological|COVID-19 exposure|Observation only
15813162|NCT04340908|Drug|Dapagliflozin 10 MG|10 mg tablet, oral, once daily, 1-year treatment, postoperation
15813163|NCT04340908|Drug|Placebos|matching placebo tablet, oral, once daily, 1-year treatment, postoperation
15813166|NCT04340882|Drug|Docetaxel|Given IV
15813167|NCT04340882|Biological|Pembrolizumab|Given IV
15813168|NCT04340882|Biological|Ramucirumab|Given IV
15813169|NCT04340869|Other|Theobromine|Natural extract from Cocoa
15813170|NCT04340869|Other|Remin Pro|Remin Pro
15813171|NCT04340856|Procedure|colon surgery|There are no guidelines to direct surgical therapy in patients with chronic megacolon. Historically, it is the surgeons individual choice to use one of the above mentioned surgical treatments. Therefore, the aim of this study is to analyze the success and downsides of the different surgical approaches.
15813172|NCT04340856|Drug|Laxatives|There are no guidelines to direct laxative measures in patients with chronic megacolon. Historically, it is the gastroenterologists individual choice to use one of the above mentioned laxative measures. Therefore, the aim of this study is to analyze the success and downsides of the different Laxative measures.
15813173|NCT04340843|Drug|Belinostat|Given IV
15813174|NCT04340843|Procedure|Biopsy|Undergo biopsy
15813175|NCT04340843|Procedure|Computed Tomography|Undergo CT
15813176|NCT04340843|Drug|Decitabine and Cedazuridine|Given PO
15813177|NCT04340843|Drug|Guadecitabine|Given SC
15813178|NCT04340843|Procedure|Magnetic Resonance Imaging|Undergo MRI
15813179|NCT04340830|Procedure|Free gingival graft|Following recipient site preparation, free gingival graft obtained from palatal mucosa was applied to buccal sites of dental implants having inadequate keratinized attached mucosa.
15813180|NCT04340817|Diagnostic Test|Proteomics|Mass-spectometry proteomics
15813181|NCT04340817|Diagnostic Test|Transcriptomics|Next generation sequencing
15813182|NCT04340817|Genetic|Genomics|Targeted genetics
15813183|NCT04340804|Behavioral|Kcal labelling|Real-time kcal counter synchronised with the food amount changes
15813184|NCT04340804|Behavioral|PACE labelling|Real-time PACE counter (as minutes needed to walk to burn off the calories) synchronised to the food amount changes
15813185|NCT04340791|Behavioral|Increased proportion of lower energy density items|The proportion of lower energy density vs. higher energy density items will be reversed (67% lower - 33% higher) relative to the default proportion condition (D and DL) (33% lower - 67% higher). Lower energy density items will be defined as lower energy density ≤ median of energy density distribution within a food category.
15813186|NCT04340791|Behavioral|Labelling|"When energy density of an item ≤ median of ED distribution within a food category, healthier choice badges will be added to the food item pictures on the online supermarket. Instructions when logging-into the platform will introduce the badges to the participants: In the online supermarket, the green tick allows you to see which products (e.g. muesli) in each product category (e.g. cereals) are healthier choices with fewer calories per gram than most other products in the same category."
15813187|NCT04340778|Drug|vaginal dinoprostone|vaginal dinoprostone 3 mg will be given 3 hours before copper IUD insertion plus inert placebo cream will be applied on the cervix at the time of IUD insertion
15813188|NCT04340778|Drug|Lidocaine-prilocaine Cream|Lidocaine-prilocaine Cream will be applied on the cervix at the time of IUD insertion plus vaginal placebo tablet will be given 3 hours prior to IUD insertion
15813189|NCT04340778|Drug|placebo|inert placebo Cream will be applied on the cervix at the time of IUD insertion plus vaginal placebo tablet will be given 3 hours prior to IUD insertion
15813190|NCT04340765|Drug|18F-fluorocholine|Dual phase 18F-fluorocholine PET/CT
15813191|NCT04340752|Drug|Indocyanine Green|ICG is an injectable fluorescent pigment that binds to proteins in the blood and allows surgery teams to view blood vessels with greater precision. The ICG will not affect the course of the operative or postoperative period, and will be injected intravenously prior to the actual repair
15813192|NCT04340739|Other|online patient education teach mindfulness based stress reduction|This is an online self management chronic pain curriculum that presents adapted Mindfulness Based Stress Reduction through videos, audios, and written materials
15813193|NCT04340726|Procedure|One time abutment|
15813194|NCT04340713|Other|information support program|According to the established information support program for prostate cancer patients during hormonal therapy, information support and guidance on disease knowledge, symptom management, life care and other aspects are provided to patients through face-to-face communication, telephone, written information, network and other ways.
15813195|NCT04340700|Drug|THC or Placebo|A standard dose of THC (8 mg or 2 mg) will be placed in a Volcano Vaporizer chamber. The first THC dose is 8 mg, followed by approximately three doses of 2 mg each. Placebo will also be administered through a Volcano Vaporizer via inhalation. The first placebo dose is 8 mg, followed by approximately three doses of 2 mg each to match the THC procedures.
15813196|NCT04340687|Device|Pancreatic duct stenting|A stent placed in the pancreatic duct to reduce PEP possibly by relieving pancreatic ductal hypertension that develops because of transient procedure-induced edema and stenosis of the pancreatic orifice
15813197|NCT04340674|Other|Telerehabilitation based on aerobic exercise|To perform different whole body aerobic exercises moderately intense according to Borg scale.
15813198|NCT04340661|Dietary Supplement|BIOintestil|Ginger ryzoma powder and Palmrose essential oil (Cymbopogon Martinii)
15813199|NCT04340661|Dietary Supplement|PLACEBO|Cornstarch
15813200|NCT04340648|Device|Vital GlucoseDetect|11 time points for blood glucose measurements over 210 min including the ingestion of a standardized meal 30 min after the first blood glucose measurement.
15813201|NCT04340622|Device|supra-luminous LED|810 nm light-emitting diode for the delivery of 2.1 J/cm2 to the brain.
15813202|NCT04340622|Device|Sham|Light-emitting diode covered with aluminium foil
15813203|NCT04340609|Biological|Mesenchymal Stem Cells|The UC-MSCs from a donor will be cultured in a clinical grade laboratory with xeno-free medium. Maximum passage of expanded-UC MSCs was VI and doubling population is less than 30. To assure the quality of our expanded-UC MSCs at ProSTEM the following tests are done: cell adherence, cell surface marker, in vitro differentiation, cell viability, sterility, Mycoplasma, endotoxin, and karyotyping.
15813207|NCT04340570|Behavioral|Medication management via televisit to home|Pharmacist led home based televisit for medication management
15813208|NCT04340557|Drug|Losartan|Standard of care plus the starting dose of losartan 12.5mg (investigator has option to increase dose on days 2-10 based on tolerance of SBP) of losartan taken twice daily for up to 10 days. Upon the treating clinician's discretion, losartan may be continued beyond 10 days for non-COVID-19 indications.
15813209|NCT04340544|Drug|Hydroxychloroquine|Hydroxychloroquine Sulfate is an anti-malarial and anti-rheumatic drug and seems to be a potential candidate for the treatment of COVID-19 since it is able to block virus infection by increasing the endosomal pH, required for virus/cell fusion, it affects the activation of p38 mitogen-activated protein kinase (MAPK), involved in the replication of HCoV-229E and can interfere with the terminal glycosylation of ACE2, thus inhibiting SARS-CoV-2 infection.
15813210|NCT04340544|Drug|Placebo|Placebo capsules
15813211|NCT04340531|Other|Best Practice|Receive usual care
15813212|NCT04340531|Other|Survey Administration|Ancillary studies
15813213|NCT04340531|Other|Tobacco Cessation Counseling|Receive referred to counseling session
15813214|NCT04340531|Other|Tobacco Cessation Counseling|Receive phone counseling
15813215|NCT04340531|Other|Training|Undergo training
15813216|NCT04340518|Device|Scleral lens|Scleral contact lenses, manufactured in rigid gas permeable fluorosilicone acrylate polymers and treated with plasma treatment prior to use.
15813217|NCT04340505|Drug|Fluocinolone Acetonide|Injection of fluocinolone acetonide implant will be injected as standard of care treatment for patients with active uveitis.
15813218|NCT04340492|Other|Education to Adapted Physical Activity|4 group sessions (5 patients) aiming at promoting physical activity, the first three focusing respectively on endurance, posture and balance and power re-enforcement at one-week interval. A fourth session, 3 months latter is a consolidating session aiming at identify and overcome obstacles to practice physical activity in everyday life.
15813219|NCT04340492|Other|Standard care|Standard care concerning Parkinson's disease and physical activity
15813220|NCT04340479|Diagnostic Test|Ultrasound lung imaging as part of FAST+ evaluation|"FAST+ evaluations will expand on the traditional FAST exam to systematically survey bilateral lung fields. Traditional FAST evaluation will survey the perihepatic, perisplenic, pelvic, and pericardial areas. Representative images will be saved by the performing provider for further evaluation. Up to sixteen areas in total will be included in FAST+ evaluation:
~Anterior midclavicular right and left (apical, medial, basal)
~Posterior paraspinal right and left* (apical, medial, basal)
~*Posterior lung evaluation will be omitted if patients are at risk for further traumatic injury from repeated side rolling.
~Lateral axillary medial right and left (apical and basal)
~Specifically, we will document the presence or absence of bilateral, diffuse pleural line abnormalities, subpleural consolidations, white lung areas and thick, irregular vertical artifacts in these lung fields by ultrasound and will record these findings."
15813221|NCT04340466|Other|No intervention|No intervention
15813396|NCT04339062|Drug|Everolimus|Everolimus at least 7-10 days prior to receiving the first dose of cemiplimab (Cycle 1, Day 1) and then daily while eceiving Cemiplimab
15813397|NCT04339062|Drug|Sirolimus|Sirolimus at least 7-10 days prior to receiving the first dose of cemiplimab (Cycle 1, Day 1) and then daily while receiving Cemiplimab
15813222|NCT04340453|Other|Exercise with Blood Flow restriction training|3 times a week for 4 weeks to a total of 12 sessions. BFR cuff (Sports Rehab Tourniquet©) will be used, with a width of 10cm and a length of 116cm or 84cm depending on the diameter of the participants thigh. Therapy sessions will be supervised and in groups. Exercises focus on strengthening the hip extensors and abductors, as well as the quadriceps both in open and closed kinetic chain. Exercises will be carried out using will be set at a load of 30% of 1RM with a limb occlusion pressure (LOP) of 70%. The first set will consist of 30reps. followed by 3 sets of 15reps. at 2:2 (con/ecc) at 60bpm by Metronome app. with auditory cue. Rest between sets will be 30sec and between exercises 2min. Cuffs will be deflated during the resting period between exercises and re-inflated at the beginning of the next exercise. Exercise progression will be individualized based on assessments at the beginning of each week. The duration has been estimated to be approximately 60min. including LOP estimation.
15813223|NCT04340453|Other|Hip and Knee Exercise Program|A supervised hip and knee strengthening exercise protocol with a combination of stretching, 3 times a week for 4 weeks to a total of 12 sessions. Exercises focus on hip extensors, abductors, as well as the quadriceps and hamstrings strength. Open Kinetic Chain (OKC) exercises will be executed first followed by CKC exercises. Exercises using weights or mechanical resistance will be set at a load of 70% of 1RM and 3 sets of 10 rep. for each exercise. Elastic band exercises will be set at 10RM for 3 sets. Tempo will be set by the Metronome app installed on a Smartphone at 1:2 (con/ecc) at 60bpm with auditory cue. Rest between sets will be 30sec and between exercises 2min. Exercise progression will be individualized based on assessments at the beginning of each week. The duration of each session is estimated to be approximately 45min, with the exception of the first session of each week which is estimated to be 80min due to the addition of strength testing
15813224|NCT04340453|Other|stretching|Both groups will receive stretching of the hamstrings, plantar flexors, quadriceps and Iliotibial Band (ITB) in the same manor at the end of each session. Passive stretching will be executed by the physiotherapist with 3x30sec stretch for each muscle group
15813225|NCT04340440|Procedure|D1 lymphadenectomy|Radical gastrectomy with D1 lymphadenectomy
15813226|NCT04340440|Procedure|D2 lymphadenectomy|Radical gastrectomy with D2 lymphadenectomy
15813227|NCT04340427|Drug|TQB3455|TQB3455 tablets is a small molecule oral drug inhibiting IDH2 mutation.
15813228|NCT04340414|Device|Low flow ECMO driving by CVVH machine|With aim to clear CO2 and improve oxygenation, a low flow ECMO treatment(using oxgyenator membrane of kid type ) driving by CVVH machine will be performed in the NCP with severe ARDS
15813229|NCT04340401|Drug|SHR-1210|Patients will receive 3 cycles induction CapeOX and SHR-1210
15813230|NCT04340401|Drug|Oxaliplatin|CapeOX is a combination chemotherapy regimen with OXA and CAPE, patients with high-risk rectal cancer will receive 3 cycles induction CapeOX and SHR-1210, intensity modulated radiotherapy with concurrent capecitabine and 2 cycles consolidation CapeOX and total mesorectal excision.
15813231|NCT04340401|Drug|Capecitabine|CapeOX is a combination chemotherapy regimen with OXA and CAPE, patients with high-risk rectal cancer will receive 3 cycles induction CapeOX and SHR-1210, intensity modulated radiotherapy with concurrent capecitabine and 2 cycles consolidation CapeOX and total mesorectal excision.
15813232|NCT04340401|Radiation|Intensity modulated radiotherapy|patients will receive intensity modulated radiotherapy with capecitabine
15813233|NCT04340401|Procedure|Total mesorectal excision|Patients will receive TME (Total mesorectal excision) following TNT+SHR1210 if no metastasis occurs.
15813234|NCT04340388|Drug|Dolutegravir 50 MG|15 participants will be randomized to remain on fully suppressive background antiretroviral therapy. The third agent will be switched to dolutegravir at the dose of 50 mg daily.
15813235|NCT04340388|Drug|Antiretroviral/Anti HIV|15 participants with suppressed HIV disease for greater than or equal to 3 months will be randomized to remain on their current 2 or 3 drug fully suppressive antiretroviral regimen.
15813236|NCT04340375|Dietary Supplement|AP green tea extracts|AP green tea extracts
15813237|NCT04340362|Drug|VX-147|Tablets for oral administration
15813238|NCT04340349|Drug|Hydroxychloroquine Sulfate|A daily low dose of Hydroxychloroquine Sulfate. Increase the endosomal pH and inhibits of ACE2 glycosylation receptor.
15813239|NCT04340349|Drug|Bromhexine 8 MG|TMPRSS2 blocker
15813240|NCT04340323|Other|Pelvic Floor Muscle Training (PFMT)|The method of first choice in SUI treatment according to the International Continence Society (ICS) is training of the pelvic floor muscles. Pelvic floor muscle training (PFMT) is a method based on scientific evidence, defined by the ICS as repeated selective voluntary contraction and relaxation of specific pelvic floor muscles. It is important to train the strength and endurance of the pelvic floor muscles but also their relaxation (Abrams, 2018; Arnold, 2014; Bo, 2013).
15813241|NCT04340310|Diagnostic Test|Home respiratory polygraphy|Home respiratory polygraphy or Polysomnography to stablish a therapeutic decission
15813242|NCT04340297|Drug|Tongjiang series prescription(Tongjiang granules, Jianpi Qinghua granules and Wenpi Qingwei granules)|According to the syndrome differentiation of TCM, Tongjiang granules are taken orally by patients with liver-stomach depression-heat syndrome, Jianpi Qinghua granules are taken orally by patients with spleen deficiency damp-heat syndrome, Wenpi Qingwei granules are taken orally by patients with cold-heat complicated syndrome, 1 bag per time, 3 times a day and 1 hour after a meal.
15813243|NCT04340297|Drug|Acid inhibitors|In the 1-2 weeks, acid inhibitor (PPI) was reduced from the dose before entering the group to half of the dose, once a day, before going to bed; in the 3-4 weeks, acid inhibitor was changed from PPI to famotidine tablets, 20mg each time, before going to bed; in the 5-6 weeks, all acid inhibitors were stopped.
15813244|NCT04340297|Drug|Placebo|Tongjiang granules placebo , Jianpi Qinghua granules placebo and Wenpi Qingwei granules placebo. The above three kinds of granulated placebo are respectively made of the simulation containing the low dose original prescription. Taking method is the same as Tongjiang series prescription.
15813245|NCT04340284|Biological|autologous adipose tissue derived stromal vascular fraction (SVF)|"liquid and solid portion of lipo-aspirate after non enzymatic processing yields SVF.
~This isolation process yielded an abundant population of Adipose stromal cells(ASCs) which have multipotent differentiation potential. Immunophenotype is a CD14-, CD29+, CD31-, CD34low/+, CD45-, CD73+ and CD105+ ,
~, the SVF represents the 50-70% in volume of a lipoaspirate specimen. The SVF hosts a heterogeneous cell population (110x103 cells/ml on average) comprising mainly CD105+ mesenchymal stem cells (MSC, 20%), plus a wide number of CD34+ hematopoietic cells (40%)."
15814554|NCT04329494|Other|Questionnaire Administration|Ancillary studies
15813246|NCT04340271|Other|Extracorporeal shock wave therapy|ESWT was conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen, Switzerland) with an electromagnetic cylindrical coil source for the focused shock wave (Fig. 2). ESWT was performed around the primary treatment site at 100 impulses/cm2, an energy flux density(EFD) of 0.05 to 0.30 mJ/mm2, frequency of 4Hz, and 1000 to 2000 impulses were administered at 1-week intervals for 4 sessions.
15813247|NCT04340271|Other|conventional occupational therapy|Standard accupational therapy consist of range of motion exercise, strengthening exercises, and activities of daily living exercises
15813248|NCT04340258|Device|Cesium-131|Cs-131 brachytherapy seed is a low-energy-gamma isotope that is contained in a titanium capsule. Dosing will be determined by a radiation oncologist study team member based on CT scan and intraoperative findings. The number of seeds and spacing will be outlined preoperatively based on the proposed square area of exposure in the resection bed. The plan is to deliver a total of 60-70Gy of radiation to the site.
15813249|NCT04340258|Drug|Pembrolizumab|Pembrolizumab 200 mg will be administered as a 30-minute IV infusion every 3 weeks. The drug will be infused through a peripheral line or an indwelling catheter. The first dose will be given 2 weeks prior to surgery. Post-surgery, pembrolizumab will be started between 2 and 6 weeks and will continue every 3 weeks for a duration of 6 months. Study Drug may be administered up to 3 days before or after the scheduled Day 1 of each cycle due to administrative reasons. The Investigator's Brochure contains specific instructions for the preparation of the standard of care pembrolizumab infusion fluid.
15813250|NCT04340245|Other|NA (Observational)|No interventions will be carried out. Comparisons will be made between patients whose cancer has progressed over the course of one year and patients whose cancer hasn't.
15813251|NCT04340232|Drug|Baricitinib|Subjects will receive a 2 mg oral dose of baricitinib.
15813252|NCT04340219|Other|Survey administration|Covid-19 Peritraumatic Distress Index, Depression Anxiety Stress Scale-21, WHO Quality of Life-BREF
15813253|NCT04340206|Behavioral|face-to-face support and Chatbot online support group|Behavioral: Structured web- and mobile-based intervention with Youth Compass plus program to support adolescents' psychological flexibility, well-being, and subsequently support successful transition to upper secondary education. The Youth Compass plus is a five-week online program aiming to enhance adolescents' psychological flexibility by guiding adolescents in exploring their values and setting goals and changing behaviors according to their goals (week 1), and learning acceptance, defusion and mindfulness skills (weeks 2-3) and integrating these skills into their personal and social life (weeks 4-5). The participants in this condition receive weekly online support and feedback from the eCoach built within the program. In addition, they meet and get support from their human coach (i.e., psychology student) twice in the face-to-face meetings.
15813254|NCT04340206|Behavioral|only chat-robot online support group|Behavioral: Structured web- and mobile-based intervention with Youth Compass plus program to adolescents' psychological flexibility, well-being, and subsequently support successful transition to upper secondary education. The Youth Compass plus is a five-week online program aiming to enhance adolescents' psychological flexibility by guiding adolescents in exploring their values and setting goals and changing behaviors according to their goals (week 1), and learning acceptance, defusion and mindfulness skills (weeks 2-3) and integrating these skills into their personal and social life (weeks 4-5). The participants in this condition receive weekly online support and feedback from the eCoach built within the program.
15813255|NCT04340206|Behavioral|Control group, no intervention|Behavioral: No intervention
15813258|NCT04340180|Drug|Standard of Care (SOC) gadolinium Breast MRI|Standard of Care (SOC) gadolinium Breast MRI
15813259|NCT04340180|Drug|reduced 1/4 dose gadolinium Breast MRI with Artificial Intelligence (AI) to aid in evaluation.|reduced 1/4 dose gadolinium Breast MRI with Artificial Intelligence (AI) to aid in evaluation.
15813260|NCT04340167|Biological|Autologous humanized anti-CD22 chimeric antigen receptor T cells|CAR-T cells were manufactured from peripheral blood mononuclear cells collected by leukapheresis and frozen for multiple uses. Before each CAR T-cell infusion (day 0), patients received lymphodepleting chemotherapy composing of Fludarabine (30 mg/m2/day) and Cyclophosphamide (250 mg/m2/day) on days -5 to -3. No bridging chemotherapy was given between enrollment and infusion. In CD22 T cell clinical trials, CAR-T cells was given once. All patients underwent bone marrow (BM) biopsy examination and radiology studies on days 30 and every month to determine the response and remission status. Bone biopsy, MRD status by FCM and RT-PCR (if the patient had fusion gene), and EMDs evaluation by CT/MRI/PET-CT were also conducted before CAR T-cell infusion to determine the disease status.
15813261|NCT04340154|Biological|chimeric antigen receptor T cell|CAR-T cells were manufactured from peripheral blood mononuclear cells collected by leukapheresis and frozen for multiple uses. Before each CAR T-cell infusion (day 0), patients received lymphodepleting chemotherapy composing of Fludarabine (30 mg/m2/day) and Cyclophosphamide (250 mg/m2/day) on days -5 to -3. No bridging chemotherapy was given between enrollment and infusion. In sequential CAR-T clinical trials, CAR-T cells will be given twice（anti-CD19 CAR-T first, then anti-CD22 CAR-T). All patients underwent bone marrow (BM) biopsy examination and radiology studies on days 30 and every month to determine the response and remission status. Bone biopsy, MRD status by FCM and RT-PCR (if the patient had fusion gene), and EMDs evaluation by CT/MRI/PET-CT were also conducted before CAR-T cell infusion to determine the disease status.
15813262|NCT04340141|Drug|Oxaliplatin|Given IV
15813263|NCT04340141|Drug|Irinotecan Hydrochloride|Given IV
15813264|NCT04340141|Drug|Leucovorin Calcium|Given IV
15813265|NCT04340141|Drug|Fluorouracil|Given IV
15813266|NCT04340141|Procedure|Resection|Undergo surgical resection
15813267|NCT04340141|Other|Questionnaire Administration|Ancillary studies
15813268|NCT04340128|Drug|Meglumine antimoniate|Intra-lesional injection once a week, 0.1/cm2
15813269|NCT04340128|Drug|Meglumine antimoniate|Intra-lesional injection twice a week, 0.1/cm2
15813294|NCT04339907|Other|Sampling of tears|Tears will be collected at the start of any of surgery for which the participant presents. It will be collected using a tear-wash method to allow for protein collection. 0.06 ml of saline solution 0.9% will be instilled on the ocular surface. The participants will turn their eyes with eyes closed. The tear-wash fluid will be collected from the inferior fornix of the eye using a micropipette. Tear-was fluid will be placed in codified tubes stored at -150 degrees.
15813270|NCT04340102|Behavioral|BecomeAnEx|This research study is focused on a smoking cessation program called BecomeAnEx. We are studying how to adapt BecomeAnEx for people with a mental health disorder who want to reduce or quit their tobacco smoking. BecomeAnEx includes a website that provides education about smoking and quitting. It also has a text messaging program that delivers personalized information. Persons in the program have access to real-time digital coaching with a remote coach who has experience helping people quit smoking. In addition, the program has an on-line community of current and former smokers that can provide support and encouragement.
15813271|NCT04340089|Behavioral|squatting on the toilet|the patients could go to squatting on the toilet at any time as they want to after taking the capsule
15813272|NCT04340076|Drug|Secukinumab|Maintenance/normal dose is 300 mg/4 weeks. First dose reduction step: 300 mg/6 weeks. Second dose reduction step: 300 mg/8 weeks.
15813273|NCT04340076|Drug|Ixekizumab|Maintenance/normal dose is 80 mg/4 weeks. First dose reduction step: 80 mg/6 weeks. Second dose reduction step: 80 mg/8 weeks
15813274|NCT04340076|Drug|Brodalumab|Maintenance/normal dose is 210 mg/2 weeks. First dose reduction step: 210 mg/3 weeks. Second dose reduction step: 210 mg/4 weeks.
15813275|NCT04340076|Drug|Guselkumab|Maintenance/normal dose is 100 mg/8 weeks. First dose reduction step: 100 mg/12 weeks. Second dose reduction step: 100 mg/16 weeks.
15813276|NCT04340076|Drug|Risankizumab|Maintenance/normal dose is 150 mg every 12 weeks. First dose reduction step: 150mg/18 weeks. Second dose reduction step: 150mg/24 weeks.
15813277|NCT04340076|Drug|Tildrakizumab|Maintenance/normal dose is 100 mg or 200 mg every 12 weeks. First dose reduction step: 100 mg or 200 mg/18 weeks. Second dose reduction step: 100 mg or 200 mg/24 weeks.
15813278|NCT04340063|Device|Gait training performed on a treadmill|Participants randomized to the Control group will complete high intensity gait training on a treadmill.
15813279|NCT04340063|Device|Gait training performed in a Movement Amplification Environment|The Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking
15813280|NCT04340050|Biological|anti-SARS-CoV-2 convalescent plasma|Infusion of one unit of anti-SARS-CoV-2 convalescent plasma ~300 mL over 4 hours
15813281|NCT04340037|Procedure|percutaneous nephrolithotomy|percutaneous surgery using nephroscope
15813282|NCT04340011|Other|Colposcopy|prospective resident education for colposcopy
15813283|NCT04339998|Diagnostic Test|Point-of-Care Ultrasonography (POCUS)|"The POCUS exam of the heart will capture 2 standard views commonly used to assess general cardiac function at the point of care. The details of POCUS views and exam findings of interest are outline below:
~Pulmonary POCUS Evaluation:
~B lines: absent (< 3 lines), present (> 3 lines), fused
~Consolidation: yes or no
~a. Bilateral: yes or no
~Pleural Effusion: yes or no
~Other pleural abnormalities: yes or no Score each finding based on degree of abnormalities and number of sites with abnormalities
~Cardiac POCUS Evaluation:
~Parasternal long axis
~Parasternal short axis
~Qualitative LVEF: Normal, hyperdynamic, mild-moderately depressed, severely depressed
~EPSS (E-point septal separation): normal (<10 mm), abnormal (>10 mm)
~Left ventricular (LV) mass approximation by septal thickness
~Left Ventricular Chamber Size by internal diameter at diastole"
15813284|NCT04339985|Drug|ATx201|Topical
15813285|NCT04339985|Drug|ATx201 OINTMENT vehicle|ATx201 OINTMENT vehicle
15813286|NCT04339972|Device|LIFUP|Low Intensity Focused Ultrasound Pulsation (LIFUP) is an interesting new form of brain stimulation that may be possible to stimulate non-invasively, safely, deep in the brain with focal precision.
15813287|NCT04339972|Device|Sham LIFUP|The same as LIFUP but the device is not turned on and the subject does not receive any ultrasound.
15813288|NCT04339959|Other|Remote Assessment of Physical Function with Direct Observation|An android tablet with Wi-Fi and cellular will be used to compare videoconferencing with face-to-face assessment of 2 timed, physical performance tests. The physical performance tests include the 30-second chair stand test (30s-CST) and the Timed Up & Go (TUG) test. The TUG test is measured as the time to stand from a standard arm chair, walk 10 feet, turn around, return to start and sit down. The 30s-CST is measured as the number of times a person comes to a full standing position from a chair in 30 seconds, as quickly as possible, without using ones' hands.
15813289|NCT04339959|Other|Remote Assessment of Physical Function|An android tablet with Wi-Fi and cellular will be mailed to study participants to remotely assess 2 timed, physical performance tests. The physical performance tests include the 30-second chair stand test (30s-CST) and the Timed Up & Go (TUG) test. The TUG test is measured as the time to stand from a standard arm chair, walk 10 feet, turn around, return to start and sit down. The 30s-CST is measured as the number of times a person comes to a full standing position from a chair in 30 seconds, as quickly as possible, without using ones' hands.
15813290|NCT04339946|Diagnostic Test|Three-dimensional rectal water contrast transvaginal ultrasonography (3D-RWC-TVS)|Rectal water contrast transvaginal ultrasonography is based on the distention of rectosigmoid with saline solution. Three-dimensional reconstructions convert standard 2D grayscale ultrasound acquisitions into a volumetric dataset.
15813291|NCT04339946|Diagnostic Test|Two-dimensional rectal water contrast transvaginal ultrasonography (2D-RWC-TVS)|Rectal water contrast transvaginal ultrasonography is based on the distention of rectosigmoid with saline solution.
15813292|NCT04339933|Diagnostic Test|FGFR test|Detection of FGFR gene mutations in the tumor tissue and urine of patients
15813293|NCT04339920|Diagnostic Test|Spermine Measuring Device|The Spermine Measuring Device (SMD) is a simple device, with automatic urine aspiration and also spermine level assessment. First about 30 cc urine will be freshly collected by a prepared collection device. Then the cap of the SMD will be removed and the aspiration tip of the device will be immersed into the urine specimen. After firmly pressed on the device, a small sample of urine will be aspirated into the SMD. The device will then automatically assess the urine spermine level. The result will then be read at a indicator window after about 5 minutes. If the level was below a pre-set cutoff, i.e. suggestive of having increase risk of prostate cancer, the indicator window will turn into red colour. However, if the spermine level is higher than the cutoff value, i.e. low risk of having cancer, the indicator window will turn blue.
15813336|NCT04339621|Device|LiverMultiscan|The LiverMultiscan is a quick 15 minute, contrast free MRI scan that provides three metrics on liver health namely fat, iron and fibro-inflammatory scores
15814706|NCT04328194|Other|Full clinical examination|full clinical examination will be done for the patients
15813295|NCT04339907|Other|Sampling of aqueous humor|Aqueous humor will be collected at the start of any of surgery for which the participant presents. A paracentesis of the anterior chamber is a common first step in intraocular surgeries. Aqueous humor is then commonly diluted with viscoelastic material injected inside the anterior chamber to avoid collapse of the anterior chamber. This way, the aqueous humor is commonly diluted or replaced entirely by the viscoelastic material injected during intraocular surgeries. A volume of 0.1 ml of aqueous humor will be taken by paracentesis using a 30-gauge needle connected to a 1-ml syringe. It consists of less than half of the total volume of aqueous humor in the eye. Aqueous humor will be placed in codified tubes stored at -80 degrees.
15813296|NCT04339894|Other|Duplex ultrasonography (data collection by extra-corporeal non-invasive sensors)|Search for venous thrombosis and description of thrombosis
15813297|NCT04339868|Drug|Terlipressin|Terlipressin (20-100 mcg/hr) plus norepinephrine and/or epinephrine
15813298|NCT04339868|Drug|Placebo|0.9% NaCl plus norepinephrine and/or epinephrine
15813299|NCT04339855|Other|CAD with LCI for colorectal polyp detection|Polyps within fully recorded endoscopy videos with LCI mode, covering the whole spectrum of adenomatous histology, are used to evaluate the efficacy of CAD with LCI for polyp detection.
15813300|NCT04339842|Other|Assessment of Dietary Changes in Adults in the Quarantine|The online survey will help to collect demographic data from the volunteers. Personal information and contact details, such as email, will not be asked. The survey will include questions about any increase or decrease in the consumption of main meals, snacks and fluid intake. If the participants of the study have observed changes in their dietary pattern since the beginning of the quarantine, details of these changes, such as an increase in the amount of main meal consumption, will be questioned.
15813301|NCT04339829|Drug|Dacomitinib|Dacomitinib orally on a continuous daily basis at a starting dose of 45 mg QD
15813302|NCT04339816|Drug|Azithromycin|orally or into nasogastric tube for 5 days
15813303|NCT04339816|Drug|Hydroxychloroquine|orally or into nasogastric tube for 5 days
15813304|NCT04339816|Drug|Placebo|orally or into nasogastric tube for 5 days
15813305|NCT04339803|Other|rehabilitation intervention|we use lower limb mirror therapy after stroke for two weeks
15813306|NCT04339777|Drug|Busulfan test dose|0.8 mg/kg IV infusion over 2 hours
15813307|NCT04339777|Drug|Fludarabine|40 mg/m2 IV infusion over 30 min once daily for 4 days
15813308|NCT04339777|Drug|Busulfan|"AUC Targeted Dose based on busulfan test dose PKs, IV infusion over 3 hours once daily (3.2 mg/kg IV per day will be the default dose) per the below time frame: For 10/10 Matched Related and Unrelated Donor Recipients For the High Intensity Arm, the busulfan dose will be given for 4 days (-6, -5, -4, and -3).
~For Intermediate Intensity Arm, the busulfan dose will be given for 3 days (-6,-5, and -4).
~For Low Intensity Arm, the busulfan dose will be given for 2 days on days (-6 and -5). 9/10 HLA Matched Related or Unrelated Donor Recipients For the High Intensity Arm, the busulfan dose will be given for 3 days (-6,
~-5, and -4). For the the Intermediate Intensity Arm, the busulfan dose will be given for 2 days (-6 and -5).
~For the Low Intensity Arm, the busulfan dose will be given for 1 day on day (-6)."
15813309|NCT04339777|Drug|Alemtuzumab|Alemtuzumab will be given if there is evidence of immune dysregulation. 0.03 mg/kg IV on day -11, 0.1 mg/kg IV on day -10, and 0.2 mg/kg IV on days -9 and -8
15813310|NCT04339777|Radiation|Total body Irradiation|200 cGy Transplant Day -1 (Only for 9/10 HLA Matched Related or Unrelated Donor Recipients )
15813311|NCT04339777|Procedure|Allogeneic HSCT|Stem cell transplant
15813312|NCT04339777|Drug|Tacrolimus (Tacro)|Tacrolimus 0.02 mg/kg IV continuous infusion over 24 hours starting on day +5
15813313|NCT04339777|Drug|Mycophenolate mofetil (MMF)|Mycophenolate mofetil 15 mg/kg IV over 2 hours BID starting on day +5 will continue until Approximately+35 (+/- two days)
15813314|NCT04339777|Drug|Cyclophosphamide (Cytoxan)|Cyclophosphamide: 50 mg/kg IV once daily over 2 hours on days +3 and +4, dosed according to ideal body weight
15813315|NCT04339764|Device|iPSC-derived RPE/PLGA transplantation|iPSC-derived RPE/PGLA transplantation
15813316|NCT04339764|Biological|Atuologous iPSC-derived RPE on PGLA|Administered in one eye and followed for 5 years.
15813323|NCT04339725|Other|DNA extraction|Extraction fecal DNA and compare disease group to normal group
15813324|NCT04339712|Drug|Anakinra|In case of diagnosis of MAS treatment with anakinra
15813325|NCT04339712|Drug|Tocilizumab|In case of diagnosis of immune dysregulation treatment with tocilizumab
15813326|NCT04339699|Device|NobleStitch EL Suture Mediated Closure System|Percutaneous closure of Patent Foramen Ovale (PFO) using NobleStitch EL suture Medicate Closure System
15813327|NCT04339699|Device|Amplatzer PFO Occluder|Percutaneous closure of Patent Foramen Ovale (PFO) using Amplatzer PFO Occluder
15813328|NCT04339686|Diagnostic Test|Thoracic CT Scan|Retrospective analysis of the thoracic CT scan results compared to final discharge summary
15813329|NCT04339673|Procedure|masseteric nerve block|regional bloc of masseter
15813330|NCT04339673|Procedure|trigger point injection|trigger point injection with local anesthetic
15813331|NCT04339673|Procedure|dry needling|needling with acupuncture needles of trigger points in masseter
15813332|NCT04339660|Biological|UC-MSCs|1*10E6 UC-MSCs /kg body weight suspended in 100mL saline
15813333|NCT04339660|Other|Placebo|100mL saline intravenously
15813334|NCT04339647|Behavioral|The SIMS programme|The intervention targets 5-6-year-old preschool children and their parents. Apart from the usual care, 5-6-year-old children receive oral health lessons and supervised daily tooth brushing (1000ppm F) at school over a period of 6 months, as well as home tooth brushing supervision by parents for 6 months. Parents/guardians attend a meeting with a DT team at school to discuss on child's oral health status, receive OHE and free toothbrush and fluoride toothpaste (1000ppm F) for child home tooth brushing, and receive 10 oral health infographic messages from DT over a period of 5 months (with printed versions available).
15813335|NCT04339634|Other|Simulation of Repurposed Drugs for COVID-19|This study is a simulation of adding repurposed drugs for COVID-19. We are using drug claims, and will not intervene with patient care.
15813337|NCT04339595|Biological|Tildrakizumab|Participants who have participated and completed the long-term extension phase of the reSURFACE 2 study (NCT01729754) and 12 weeks after the last Tildrakizumab dose will be included in the present study. Participants will not receive any study medication during the present study. Participants will remain in the study for 96 weeks or until they initiate any systemic therapy for psoriasis (including phototherapy), whichever occurs first.
15813338|NCT04339569|Diagnostic Test|Biomechanical analysis|3D analysis of landing manoeuvres.
15813339|NCT04339569|Other|Fatigue protocol|A circuit of different tasks (e.g. jumping, sprinting forward and backward, side-stepping exercise) was performed to induce fatigue.
15813340|NCT04339543|Other|Cognitive dual-task walking|• The task will consist in walking while performing the phoneme monitoring task. The phoneme monitoring task will consist in listening to a text through headphones, and participants will be asked to i) answer ten questions regarding the content of the text after the task, and ii) count how many times two predefined words appeared in the text. During single and dual-task walking, participants will be asked to walk around the track at a speed that they feel would be comfortable while walking through the grocery store or walking to their car, with no instructions regarding the priority to give to each task (walking vs. cognitive task).
15813341|NCT04339530|Other|Normal weight and overweight adults|Association between vitamin D levels and insulin resistance
15813342|NCT04339517|Procedure|Aspiration of seroma fluid|Fluid will be collected from the lumpectomy site of patients between one to six weeks post-surgery and tested for the presence of persistent tumor cells (PTCs).
15813343|NCT04339504|Biological|SMUP-IA-01(low-dose)|A single knee administration of SMUP-IA-01(low-dose, 4.0 x 10^6 cells/2mL)
15813344|NCT04339504|Biological|SMUP-IA-01(mid-dose)|A single knee administration of SMUP-IA-01(mid-dose, 1.0 x 10^7 cells/2mL)
15813345|NCT04339504|Biological|SMUP-IA-01(high-dose)|A single knee administration of SMUP-IA-01(high-dose, 2.0 x 10^7 cells/2mL)
15813346|NCT04339465|Behavioral|CARE-FAM|CARE-FAM is a family-based intervention for the diagnostic, early detection and early treatment of mental health issues of children affected by rare diseases, their siblings and their parents. CARE-FAM is a brief low-frequency intervention comprising six to eight sessions per family over a period of six months.
15813347|NCT04339465|Behavioral|WEP-CARE|WEP-CARE is an online-intervention that addresses parents of children and adolescents affected by rare diseases. The program is based on principles of cognitive-behavioral writing therapy. Supported by trained professionals, the participants perform 10 standardized writing tasks on a secured internet platform
15813348|NCT04339452|Device|Impella 5.0 and Impella 5.5 with SmartAssist Supported OPCABG|Subjects will undergo insertion of an axillary or ascending aortic Impella 5.0 Device or Impella 5.5 with SmartAssist, followed by Impella supported OPCABG using a sternotomy approach with shunting of the coronary arteries to achieve myocardial protection.
15813349|NCT04339439|Device|Vessel loop (FDA product code FZZ)|The intervention will be a vessel loop placed below sutures to raise the sutures from the skin of the palm.
15813350|NCT04339426|Drug|Atovaquone/Azithromycin|Atovaquone 750 mg PO Q12H for up to 10 Days Azithromycin 500 mg PO Daily 1 followed by 250 mg PO Daily for up to 10 days (days 2-10)
15813351|NCT04339413|Drug|Gantenerumab|Gantenerumab will be administered as SC injection Q4W
15813352|NCT04339400|Drug|TQ05105|TQ05105 is a JAK2 inhibitor.
15813353|NCT04339374|Device|Photoacoustic imaging, photoacoustic microscopy|"Emerging technique in which a short-pulsed laser beam penetrates diffusely into a tissue sample, causing the release of acoustic waves due to a transient temperature rise
~The transient acoustic waves, or photoacoustic waves, are then measured around the sample by US transducers
~The resolution of the devices can be altered by changing the wavelengths of laser light and spectrum analysis of the receiver. In this manner, human colorectal pathology will be examined under multiple types of photoacoustic ranges (broadly termed photoacoustic microscopy and photoacoustic imaging)
~The study is strictly observational as specimen imaging will have no impact on the clinical decision-making for the participants"
15813354|NCT04339374|Device|Endorectal photoacoustic imaging probe|"Based on data gathered in the ex vivo cohort of patients, an endorectal imaging device using coregistered photoacoustic and ultrasound imaging will be constructed. This probe will then be used to perform in vivo imaging among patients with rectal pathology intraoperatively.
~The study is strictly observational as specimen imaging will have no impact on the clinical decision-making for the participants"
15813355|NCT04339361|Drug|lidocaine spray|four puffs (50 ml, 10 mg/puff) of lidocaine spray before tenaculum placement plus vaginal placebo 3 hours before IUD insertion
15813356|NCT04339361|Drug|vaginal dinoprostone|vaginal dinoprostone 3 mg will be given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement
15813357|NCT04339361|Drug|placebo|vaginal placebo will be given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement
15813358|NCT04339348|Drug|vaginal misoprostol|vaginal misoprostol 200 mcg will be given 3 hours before LNG-IUD insertion plus inert placebo cream vaginally at the time of LNG-IUD insertion
15813359|NCT04339348|Drug|Lidocaine-Prilocaine Topical cream|Lidocaine-Prilocaine cream will be applied on the cervix at the time of LNG-IUD insertion plus vaginal placebo tablet 3 hours before LNG-IUD insertion
15813360|NCT04339348|Drug|placebo|inert placebo cream will be applied on the cervix at the time of LNG-IUD insertion plus vaginal placebo tablet 3 hours before LNG-IUD insertion
15813361|NCT04339335|Procedure|Pulsed radiofrequency of the occipital nerves|pulsed radiofrequency of the greater and lesser occipital nerves bilaterally
15813362|NCT04339322|Other|Follow up|Follow up to assess the outcome until complications, improvement, death or being transferred to another quarantine hospital.
15813363|NCT04339309|Procedure|Non-surgical periodontal treatment with interdental hygiene devices|
15813364|NCT04339309|Procedure|Non-surgical periodontal treatment without interdental hygiene devices|
15813365|NCT04339296|Device|Spencer|The MDS dispenses medications on time with visual and audio reminders. The audio alert get louder if the plastic medication packet is not dispensed from the system. The MDS allows participants to dispense their medications early if they are going to be away from home. The system also displays personalized and health-condition speciﬁc questions. The pre-packaged medications are delivered by pharmacy that inserted directly into the spencer device. Spencer system is non-inclusive and approved by Health Canada.
15813366|NCT04339283|Dietary Supplement|Standardized Hibiscus sabdariffa tea|Daily consumption of Standardized Hibiscus sabdariffa tea
15813367|NCT04339270|Drug|Azithropycin according to symptoms|"Patients randomized to the standardized comparator arm will benefit from the optimal background treatment for COPD according to national (SPLF) and international (GOLD) recommendations in force, including with regard to the prescription of azithromycin in case of severe sputum complaints (here defined by a CASA-Q sputum symptoms score <70 to homogenize practices between centers).
~CASA-Q will be listed every 3 months.
~If the patient has a sputum symptoms score <70, a prescription for 3 months of azithromycin treatment will be initiated. This prescription can be renewed every 3 months during the 12 months of follow-up planned in this study, if the patient continues to obtain a sputum symptoms score <70.
~If the patient has a sputum symptoms score> 70, management is not changed."
15813368|NCT04339270|Drug|Azithromycin according to rheology|"Patients randomized to the experimental arm will be treated according to standard management and will benefit from the optimal basic treatment of COPD according to national (SPLF) and international (GOLD) recommendations in force, except for the prescription of azithromycin, which will be prescribed in function of mucus rheology.
~The rheology of mucus will be quantified every 3 months.
~If the patient has spontaneous or induced sputum, and this sputum has a critical constraint (tau-C) > 39, a prescription for 3 months of azithromycin treatment will be initiated.
~This prescription may be renewed every 3 months during the 12 months of follow-up planned in this study.
~In the absence of sputum, azithromycin will not be prescribed."
15813369|NCT04339244|Other|RALRP under lower mean BP|RALRP under regulation of lower mean BP
15813370|NCT04339244|Other|RALRP under lower mean BP|RALRP under regulation of highly normal mean BP
15813371|NCT04339231|Procedure|sphenopalatine ganglion block|"The block of the sphenopalatine ganglion will be performed bilaterally, using a cotton bud soaked with 1% ropivacaine, placed in the mucosa of the posterior wall of the nasal cavity, through both nostrils.
~Once placed in the proper position, the swab will remain for about 20 minutes to absorb the local anesthetic from the mucosa."
15813372|NCT04339218|Device|Cryoablation|"Cryoablation will be performed by a specialized radiologist, percutaneously, ie through the skin. The operation is performed under general anesthesia, under the guidance of the scanner. The images from the scanner make it possible to precisely insert and place a needle at the level of the tumor to be treated. Intense cold will be produced by the needle and will destroy the cancer cells by freezing (temperatures of -40 °C). Freezing is localized to the tumor, the rest of the organ will not suffer from the cold.
~The aftermath of the intervention causes only minimal pain and in most cases does not require pain treatment. As the operation is minimally traumatic, the risk of complications is low. Hospitalization is around twenty-four hours and usual or professional activities can be resumed very quickly."
15813373|NCT04339218|Drug|Pembrolizumab|Pembrolizumab will be prescribed and administered at the dose recommended by market authorization.
15813374|NCT04339218|Drug|Pemetrexed|Pemetrexed will be prescribed and administered at the dose recommended by market authorization.
15813375|NCT04339218|Drug|Carboplatin|Carboplatin will be prescribed and administered at the dose recommended by market authorization.
15813376|NCT04339205|Other|Analysis of every MRI at presentation of the symptoms and then over a period of 3 to 24 months if available.|"The radiologist will analyze the MRI of patients with proved auto-immune encephalitis realized at presentation of the symptoms. If available, the following-up MRIs will also be analyzed.
~At each assessment, four MRI sequences will be studied : diffusion, T2-weighted, susceptibility sensitive sequences, and T1 weighted after contrast enhanced with gadolinium.
~The radiologist will analyse the signal abnormalities, their localisation and the trophicity of the brain.
~We will then correlate the following clinical data collected for patients : age, sex, clinical presentation, clinical evolution, and tumor associated or not."
15813377|NCT04339192|Procedure|Minimally Invasive Tricuspid Surgery|minimally invasive tricuspid surgery including endoscopy-assist right minithoracotomy, vacuum-assist single femoral venous drainage without dissecting or snaring vena cava, direct right atriotomy through pericardium and the beating-heart technique.
15813378|NCT04339166|Diagnostic Test|Non-invasive chromosome screening（NICS）|NICS is noninvasive chromosome screening approach to analysis the euploidy by free DNA in embryo culture medium
15813379|NCT04339153|Behavioral|Parent Training for Disruptive Behaviours|Critically, PT also involves education about autism during the initial sessions, and thus benefits of PT are inferred to come from the specific training.
15813380|NCT04339140|Drug|Zafirlukast|Oral tablets, 2x daily for 28 day cycle up to 1 year
15813381|NCT04339127|Other|Description and analysis|Retrospective, non-interventional study, using clinical, biological, radiological and therapeutic data collected during the initial diagnosis and follow-up.
15813382|NCT04339114|Other|Breakfast: control meal|The breakfast meal includes a Taiwanese style pancake plus a side of hash browns with ketchup. Every meal will be individualized to meet the 30% of the energy requirement of subjects based on the Harris benedict equation.
15813383|NCT04339114|Other|Breakfast: Cinnamon meal|The breakfast meal includes a Taiwanese style pancake seasoned with grounded cinnamon plus a side of hash browns with ketchup. Every meal will be individualized to meet the 30% of the energy requirement of subjects based on the Harris benedict equation.
15813384|NCT04339114|Other|Breakfast: Italian herbs meal|The breakfast meal includes a Taiwanese style pancake seasoned with Italian herbs plus a side of hash browns with ketchup. Every meal will be individualized to meet the 30% of the energy requirement of subjects based on the Harris benedict equation.
15813385|NCT04339114|Other|Breakfast: pumpkin spice|The breakfast meal includes a Taiwanese style pancake seasoned with pumpkin spices plus a side of hash browns with ketchup. Every meal will be individualized to meet the 30% of the energy requirement of subjects based on the Harris benedict equation.
15813386|NCT04339101|Drug|Fludarabine|Given via infusion
15813387|NCT04339101|Drug|Itacitinib Adipate|Given PO
15813388|NCT04339101|Drug|Melphalan|Given IV
15813389|NCT04339101|Other|Quality-of-Life Assessment|Ancillary studies
15813390|NCT04339101|Other|Questionnaire Administration|Ancillary studies
15813391|NCT04339101|Drug|Sirolimus|Given PO
15813392|NCT04339101|Drug|Tacrolimus|Given IV or PO
15813393|NCT04339088|Other|Questionnaires|Questionnaires to assess quality of life
15813394|NCT04339075|Other|Questionnaires|Questionnaires to access the quality of life (EQ5D, VCSS, CVVQ, CIVIQ, Patient satisfaction survey)
15813395|NCT04339062|Drug|Cemiplimab|Cemiplimab: via IV, flat predetermined dosage every 21 days.
15815195|NCT04324138|Drug|Jianpi Qinghua granules|3 times a day and 1 hour after a meal, for 4 weeks
15813398|NCT04339062|Drug|Prednisone|40 mg orally the day prior to the start of cemiplimab dosing (Cycle 1, Day 1) and then daily at tapered dosing while receiving Cemiplimab
15813399|NCT04339049|Drug|lidocaine spray|four puffs (50 ml, 10 mg/puff) of lidocaine spray before tenaculum placement plus vaginal placebo 3 hours before IUD insertion
15813400|NCT04339049|Drug|vaginal misoprostol|vaginal misoprostol 200 mcg given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement
15813401|NCT04339049|Drug|placebo|vaginal placebo given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement
15813402|NCT04339036|Drug|Capecitabine Oral Product|Capecitabine 750 mg/m2 twice daily orally for 14 days
15813403|NCT04339036|Drug|Temozolomide Oral Product|temozolomide 200 mg/m2 orally on Days 10-14, with 14 days between cycles
15813404|NCT04339036|Combination Product|transarterial radioembolization|Trans-arterial radioembolization (TARE) on Day 7 of cycle 2 and, if needed for the other lobe, Day 7 of either cycle 3 or 4.
15813407|NCT04339010|Other|Hypopressive exercise|The hypopressive exercise is performed mainly via transversus abdominis (Tra) activation. The exercise relaxes the diaphragm, decreases intra-abdominal pressure and may activate the abdominal and PFM simultaneously.
15813408|NCT04339010|Other|Pelvic floor muscle contraction|Pelvic floor muscle contraction (PFMC) is performed through a sequence of contraction and relax the PFM. It will improve PFM strength and is effective for treating urinary incontinence.
15813409|NCT04338997|Drug|IZD174|Small molecule inhibitor of NLRP3
15813410|NCT04338984|Drug|General anesthetic|Fentanyl is administered at induction - standard dose 5 mcg/kg. Further dosing is based on a multiderivative assessment of nociception (NOL index) and ancillaries such as heart rate and mean arterial blood pressure.
15813411|NCT04338984|Drug|Ropivacaine 0.5% Injectable Solution|"Bilateral single shot erector spinae plane block is performed before induction of general anaesthesia.
~Ropivacaine 0.5% total dose 3mg/kg with Dexamethasone 8mg/20 ml Ropivacaine 0.5%."
15813412|NCT04338958|Drug|Ruxolitinib|2 x 10mg Ruxolitinib with defined response adapted dose escalation up to 2 x 20mg for a duration of 7 days with clinical and/or radiographic response assessment
15813413|NCT04338945|Behavioral|COVID-surgRES questionaire|The questionaire gives a multidimensional assessment of residents' impression with regard to impact of COVID emergency on Italian specialist training programs
15813414|NCT04338919|Procedure|Percutaneous coronary intervention|PCI with stent implantation
15813415|NCT04338919|Drug|Ticagrelor plus aspirin|Ticagrelor plus aspirin
15813416|NCT04338906|Drug|Camostat Mesilate|400 mg tid, d1-d7
15813417|NCT04338906|Drug|Placebo|Instead of Camostat Mesilate, tid, d1-d7
15813418|NCT04338906|Drug|Hydroxychloroquine|400 mg bid on day 1, 200 mg bid d2-d7
15813419|NCT04338893|Procedure|Device: Persona Total Knee|The choice of intervention is defined by surgeons standard use of device 'Persona' in their standard of care practice
15813420|NCT04338893|Procedure|Device: NexGen Total Knee|The choice of intervention is defined by surgeons standard use of device 'Nexgen' in their standard of care practice
15813421|NCT04338893|Procedure|Device: Vanguard Total Knee|The choice of intervention is defined by surgeons standard use of device 'Vanguard' in their standard of care practice
15813422|NCT04338867|Radiation|Whole-brain radiotherapy|Patients were randomized 1:1 and allocated to either the control arm who received whole-brain radiotherapy (WBRT) or the experimental arm who received WBRT and the addition 36 mg of transdermal nitroglycerin (TN)
15813423|NCT04338854|Procedure|Restorative Treatment|9 groups were formed as 6 restorative and 3 protective applications. The restorative treatment groups included procedures with- and without-local anesthesia (LA). Procedures with LA included the groups as root canal treatment, pulpotomy, two-surface restoration and one-surface restoration. Procedures without LA included the groups as two-surface restoration and one-surface restoration. The protective application groups included the groups as fluoride application (by disposable arch tray or by cotton roll) and fissure sealant.
15813424|NCT04338841|Other|HOME-CoV rule implementation|"HOME-CoV rule is an easy-to-use clinical rule aiming to help emergency physicians in hospitalisation or outpatient management decision making. The definition of the rule is performed using the Delphi method to reach a consensus of a large panel of experts.
~Between before and after period, educational lectures, posters, and pocket cards showing and explaining HOME-CoV rule are communicated to participating Emergency Departments."
15813425|NCT04338828|Drug|Nitric Oxide Gas|Inhaled NO administered at target inspired concentration 140 - 300 ppm for 20-30 minutes
15813426|NCT04338828|Other|Inhaled Supplemental Oxygen|2 L/min oxygen therapy
15813427|NCT04338815|Other|Exoskeleton optimization|Participants will walk 10 times 1 minute while an optimization algorithm changes the assistance profile of an exoskeleton.
15813428|NCT04338815|Other|Endurance evaluation|Participants will walk 2 times at a speed of 1 meter per second until the participant indicates claudication or a maximum duration of 6 minutes.
15813429|NCT04338802|Drug|Nintedanib 150 MG|Nintedanib cloth sulfonate 150 mg, twice a day, about 12 hours apart. Continuous medication for 8 weeks.
15813430|NCT04338802|Other|Placebo|Empty capsules with the same appearance and ingredients as Nidanib soft capsules: one capsule at a time, twice a day, with an interval of about 12 hours each time. Continuous medication for 8 weeks.
15813431|NCT04338789|Other|Piezocision|Piezocesion was performed by making 2 vertical incisions mesial and distal to the extraction space. Piezotome was inserted in the incisions previously made and bone cuts were done with a length up to mucogingival line and depth of 3 mm.
15813432|NCT04338776|Device|UroLift|"The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH).
~During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra."
15813433|NCT04338776|Device|Rezum|"The Rezūm™ System is intended to relieve symptoms, obstructions, and reduce prostate tissue associated with BPH.
~The Rezūm System is manufactured by Boston Scientific and consists of a radiofrequency (RF) generator and a single-use transurethral delivery device.
~The Rezūm System utilizes radiofrequency current to generate wet thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released,reducing the volume tissue adjacent to the urethra."
15813434|NCT04338763|Drug|RP72|RP72 is formulated as a sterile lyophilized powder which is reconstituted in sterile water for injection (WFI) prior to administration. IV injection of RP72 will be administered thrice weekly in the first 28-day treatment cycle (Cycle 1). RP72 will continue to be administered thrice weekly for 4 weeks for Cycle 2 and each subsequent 28-day treatment cycle.
15813435|NCT04338763|Drug|Gemcitabine|Gemcitabine is an anti-cancer chemotherapy drug. IV infusion of Gemcitabine will be administered once weekly in the first 28-day treatment cycle (Cycle 1). Gemcitabine will continue to be administered once weekly for the first 3 weeks and then one week rest in Cycle 2 and each subsequent 28-day treatment cycle.
15813436|NCT04338750|Behavioral|Telephone Acceptance and Commitment Therapy Intervention for Caregivers|Participants randomized to TACTICs will receive a manualized acceptance and commitment therapy intervention delivered via phone in 6 weekly 1-hour sessions by a trained Bachelor's-level interventionist.
15813437|NCT04338750|Behavioral|minimally-Enhanced Usual Care|Participants randomized to mEUC will receive information about dementia caregiver support groups near their home and educational, science-based reading and resources from the National Institute on Aging from the National Institutes of Health.
15813438|NCT04338737|Other|timming of feeding|post-operative oral feeding receiving water and clear fluid after surgery, followed by soft food and regular diet
15813439|NCT04338724|Drug|CS1002|The dose levels will be escalated following a modified 3+3 dose escalation scheme.
15813440|NCT04338711|Drug|tofacitinib modified release (MR)|"Single oral 10 mg multi particulate dose of dose of tofacitinib MR with different levels of enteric coating (MR E1, MR E2, and MR E3) in the fasted state. Additionally, the lowest and highest enteric coating levels will also be evaluated in the fed state.
~Treatment F: a 10 mg oral dose of tofacitinib IR solution"
15813441|NCT04338698|Drug|Hydroxychloroquine|Hydroxychloroquine Phosphate/Sulfate (200 mg orally thrice a day for 5 days)
15813442|NCT04338698|Drug|Oseltamivir|Oseltamivir (75 mg orally twice a day for 5 days)
15813443|NCT04338698|Drug|Azithromycin|Azithromycin (500 mg orally once a day on day 1, followed by 250 mg orally daily on days 2-5)
15813444|NCT04338685|Drug|RO7119929|RO7119929 will be administered orally as a capsule at starting dose 1 mg on weekly (QW) dosing regimen
15813445|NCT04338685|Drug|Tocilizumab|"Tocilizumab will be administered in case of severe steroid-refractory cytokine release syndrome.
~Tocilizumab will be administered as concentrate for solution for IV infusion at a dose: for participants > 30 kg: 8 mg/kg, for participants < 30 kg: 12mg/kg IV"
15813446|NCT04338672|Other|COVID-19 Pandemic|Exposure: the novel coronavirus disease (Covid-19) outbreak
15813447|NCT04338659|Biological|IBI322|Recombinant anti-human CD47/PD-L1 bispecific antibody injection
15813448|NCT04338646|Other|Clinical tests|Questionnaire about urinary symptoms, gait difficulties, fear of falling. Clinical test: Time to be Ready to Void
15813449|NCT04338633|Drug|Conventional calcium hydroxide paste|Conventional calcium hydroxide paste (Ultracal) will be removed in second visit.
15813450|NCT04338633|Drug|Calcium hydroxide nanoparticle|Calcium hydroxide nanoparticle. manufactured in NanoTech. institute, will be removed in second visit.
15813451|NCT04338633|Drug|Combined Calcium hydroxide with silver nanoparticle|Combined Calcium hydroxide with silver nanoparticle will be removed in second visit.
15813452|NCT04338620|Drug|camrelizumab combined with albumin-bound paclitaxel and cisplatin|Camrelizumab will be administered as a 30-minute IV infusion Q3W at a dose of 200mg on day1 of each cycle. Albumin-bound paclitaxel will be administered as a 30-minute IV infusion Q3W at a dose of 130 mg/m2 on day1 and day8 of each cycle. Cisplatin will be administered as a dose of 75 mg/m2 on day1 of each cycle.
15813453|NCT04338607|Procedure|Subtalar (Talocalcaneal) arthrodesis|Subtalar (Talocalcaneal) arthrodesis with a novel sustained dynamic compression intramedullary nail
15813454|NCT04338607|Device|DynaNail Mini|Utilization of a novel sustained dynamic compression pseudoelastic intramedullary nail
15813455|NCT04338581|Biological|AMG 714|anti-IL-15 monoclonal antibody (Anti-IL-15 MAB)
15813456|NCT04338581|Biological|Placebo|Placebo for AMG 714
15813457|NCT04338581|Procedure|nbUVB phototherapy|Participants will undergo narrow band ultraviolet B (nbUVB) phototherapy if their total body Vitiligo Area Scoring Index (T-VASI) does not improve by ≥ 25% at Week 24 compared to Week 0. Phototherapy will be administered in accordance with the Vitiligo Working Group expert recommendations.
15813458|NCT04338568|Diagnostic Test|Lung ultrasound|The lung ultrasound examination consists of two-sided scanning of the anterior and lateral chest wall and is performed with patients in supine or near-to-supine position.
15813460|NCT04338542|Genetic|Tumor biobsies analysis|Analysis on archived tumor biopsies
15813462|NCT04338516|Device|Ossix™ Bone|a resorbable sponge-like matrix of 80% hydroxyapatite and 20% sugar cross-linked porcine collagen
15813463|NCT04338516|Device|Bio-Oss® Collagen|90% bovine derived xenograft granules and 10% porcine collagen
15813464|NCT04338503|Diagnostic Test|Partial IVC occlusion|Partial balloon occlusion of the inferior vena cava.
15813465|NCT04338490|Device|Feedback mannequim|The intervention group received rcp training with their performance being evaluated in real time so that they could correct themselves
15813466|NCT04338477|Drug|Nephrosolid tablets|Adminstration of drug
15813499|NCT04338191|Drug|mFOLFOXIRI adjuvant chemotherapy|mFOLFOXIRI (oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) for 6 cycles
15813467|NCT04338464|Behavioral|Psychosocial therapy for South Asian women experiencing mood disorders|"The 12 week intervention has four major components:
~Relational theory (Belgrave, 2002) & South Asian identity development (Inman et al., 2001). These foundational components focus on strengthening cultural identity through the exploration of values, navigation and reconciliation of two cultures.
~Transdiagnostic treatment of mood disorders (Ehrenreich-May et al., 2017). This component will focus on skill building in the areas of emotion awareness, resilience, adaptability, self-compassion and healthy coping strategies (Farchione et al., 2012; Bilek & Ehrenriech-May, 2012; Ritschel, Noriel & Lindsay, 2015).
~Psychoeducation on mental health, sexual health, and substance use.
~Peer support is a critical component of the intervention and will be provided by the peer researcher on the team. Participants will have access to optional individual peer support for 30 minutes to one hour per week for the duration of the intervention, this can be in person or telephone support."
15813468|NCT04338451|Other|Music during the first part of ESWL|Music listening during first part of ESWL
15813469|NCT04338451|Other|Music during the second part of ESWL|Music listening during second part of ESWL
15813470|NCT04338438|Drug|Apatinib Mesylate tablets combined with S-1 capsules|Apatinib Mesylate tablets combined with S-1 capsules, p.o.
15813471|NCT04338425|Behavioral|Voice call|Attending surgeons will contact with their patients on the day of surgery after discharge via voice call.
15813472|NCT04338425|Behavioral|Video call|Attending surgeons will contact with their patients on the day of surgery after discharge via video call (video conferencing application such as FaceTime or Skype)
15813473|NCT04338412|Device|ProSeal-LMA™|It is a second generation LMA that is commonly used among all other LMAs
15813475|NCT04338373|Combination Product|"0.01% Atropine sulfate solution in Comfort Drops (AVIZOR S.A., Spain)"|"nightly instillations of 0.01% Atropine sulfate solution in Comfort Drops (AVIZOR S.A., Spain) in both eyes for 12 months"
15813476|NCT04338360|Biological|COVID-19 convalescent plasma|COVID-19 convalescent plasma
15813477|NCT04338347|Biological|CAP-1002 Allogeneic Cardiosphere-Derived Cells|Extracellular Vesicles (EVs) from Cardiosphere-Derived Cells (CDCs)
15813478|NCT04338334|Other|Manual drainage & arm therapeutic exercise|See arm/group descriptions.
15813479|NCT04338334|Other|Cohesive bandaging & arm therapeutic exercise|See arm/group descriptions.
15813487|NCT04338308|Device|new-DES|with ot without embolic protection device
15813488|NCT04338308|Device|BMS|with ot without embolic protection device
15813489|NCT04338295|Device|Tattoo machine (SOL Nova Device)|A SOL Nova Device (brand) tattoo machine will be used to stimulate hair regrowth.
15813490|NCT04338282|Drug|toripalimab|240mg/d, every 3 weeks, for up to one year or until disease progression, whichever comes first
15813493|NCT04338256|Behavioral|Wellness and Resilience for College and Beyond (Undergraduate College Course)|"The course, Wellness and Resilience for College and Beyond was originally developed by James Mazza, PhD and colleagues at the University of Washington as a 10-week course. The course developers adapted their course materials to fit the needs of a 16-week semester for the purpose of this study. The Wellness Course teaches students evidence-based skills for improving mental health from dialectical behavior therapy, acceptance and commitment therapy, and the field of positive psychology. Classes meet for 2.5 hours weekly with approximately half of class time spent on teaching new content (lecture) and the other half spent with students working in small groups on practice and discussion exercises."
15813494|NCT04338243|Drug|Glumetinib|Phase Ib is a dose escalation study, the initial dose of Glumetinib is 300mg, then will be escalated to 400mg，according to the result of Phase Ib， will confirm the RP2D
15813495|NCT04338230|Other|Progressive muscle relaxation exercise|"Relaxation Exercises CD Audio Records prepared by Turkish Psychological Association is used. Before starting the PMR exercises, the woman in the intervention group is provided to lie on a comfortable seat or bed, stretching the muscles of the face and all body for about 10 seconds starting from the hands to the foot in line with the sound recordings of the PKG exercises and then holding the deep breath while each muscle group is stretching, It is applied as a slow release of this breath during relaxation. In this way, the muscle groups in the hands, arms, neck, shoulders, chest, abdomen, hips, feet and fingers, the face and the whole body are tensioned and relaxed, and the woman is relaxed. During the eight-week period, the women are called by the researcher once a week and the exercises are reminded. Home visit There are 2 home visits at week 1 and at week 8. In case of need, repeated home visits are provided to ensure the continuity of the application."
15813496|NCT04338217|Device|Bionator|This is a functional appliance that is used to overcome the functional problems and to correct the open bite deformity
15813497|NCT04338217|Device|Removable Appliance with Posterior Bite Planes|This is a one-jaw appliance that is used in conjunction with a tongue crib to control the faulty positions of the tongue and to help in closing the open bite through the use of posterior bite planes.
15813498|NCT04338204|Drug|tofacitinib|Observational study
15813500|NCT04338191|Drug|mFOLFOX6 adjuvant chemotherapy|mFOLFOXIRI (oxaliplatin 85 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 400mg/m2 infusion, and 2400mg/m2 as a 46-hour continuous infusion on day 1) for 6 cycles
15813501|NCT04338178|Behavioral|Cognitive Remediation Therapy (CRT)|This intervention consists of mental exercises aimed at improving executive function via practice. Simple cognitive tasks that encourage reflective learning and insight into patient's own thinking process are administered. Exercises target set-shifting (i.e., cognitive flexibility), estimating, organization and planning.
15813502|NCT04338178|Behavioral|Emotional Skills Training (EST)|EST places emphasis on the improvement of inner emotion awareness, facial and body expression recognition and intra- and interpersonal emotion regulation skills. Different modules and interactive exercises are designed to help patients learn about i) the functions and manifestations of emotions, ii) the identification and labelling of own's and others' emotions, iii) tolerating and communicating emotions, and iiii) balancing between negative and positive emotions.
15813503|NCT04338178|Behavioral|Cognitive Behavioral Therapy|CBT intervention aimed to manage food craving by teaching group members cognitive (e.g., restructuring of urge-related thoughts) and behavioural strategies (e.g., increasing awareness through food diaries, relaxation skills, identification of cues that trigger craving, avoidance of high-risk situations for craving, distraction).
15813504|NCT04338178|Procedure|Multidisciplinary outpatient program|Multidisciplinary outpatient program including several consultations with endocrinologists, dietitians, psychologists, nutritionists and/or physical activity coaches. Patients are regularly followed and educated about the importance of lifestyle changes including healthy dietary habits and exercise in weight reduction and maintenance. Patients are also usually given information about nutritional value of various foods and few simple exercises for decreasing and maintaining body weight. This program is therefore planned as part of the usual care and responds to the recommendations of good practice for obesity
15813505|NCT04338165|Drug|Evolocumab 140 MG/ML [Repatha]|3 injections of evolocumab 140 milligrams performed within 30 minutes and self-administered (subcutaneously in the abdomen, thigh, or upper arm)
15813506|NCT04338152|Behavioral|Family Focused Therapy for Clinical High Risk Youth (FFT-CHR)|Family-Focused Therapy (FFT) has been tested in randomized trials involving persons with bipolar disorder, depression, and clinical high-risk syndromes. FFT-CHR provides families with psychoeducation (sessions 1-6) about prodromal symptoms and the role of the family in helping maintain stability. Clients are supported in building coping skills and monitoring thoughts, perceptions, and mood. The family formulates a prevention action plan to prevent prodromal symptoms from escalating into full episodes. Communication training (sessions 7-13) teaches families to express positive and negative feelings, listen actively, make positive requests for change, and communicate clearly through role-playing and between-session practice. In problem solving (sessions 14-18) participants learn to break down problems into smaller ones, evaluate pros/cons, and choose solutions to implement.
15813507|NCT04338152|Behavioral|Enhanced Care (EC)|Enhanced care (EC) has been tested as a family educational treatment in CHR and bipolar youth. The first 3 sessions of EC involve the CHR person and family (parents, siblings) and cover the same content as the psychoeducational module of FFT in abridged form. The objective of these sessions is to develop a prevention action plan. Then, the CHR person is offered monthly individual sessions with the same clinician over the next 5 months, for a total of 8 sessions over 6 months. The individual sessions focus on applying the prevention action plan when symptoms emerge, and supportive, nondirective problem-solving regarding areas of conflict with family, with peers or in the educational or occupational arena. The clinician also serves as case manager.
15813508|NCT04338139|Procedure|bone regeneration|bone regeneration using bio-oss collagen
15813509|NCT04338126|Drug|Tranexamic acid|previously described
15813510|NCT04338126|Drug|Placebo oral tablet|previously described
15813511|NCT04338100|Procedure|Follow-up at 14 days|Point of care chest ultrasonography and 14-day follow-up to assess the evolution of the infection and care requirement (invasive ventilation or death)
15813512|NCT04338087|Other|Questionnaire and personal interviews.|Questionnaire and personal interviews.
15813513|NCT04338074|Drug|Tranexamic acid tablets|Oral dosing of 1300 mg p.o. three times per day x 5 days versus identical placebos
15813514|NCT04338074|Drug|Placebo oral tablet|2 tablets p.o. three times per day x 5 days
15813520|NCT04338035|Behavioral|Expectant management|Patients did not undergo surgical treatment for endometriosis and medical consultations were done every 6 months from the beginning of the attempts to conceive
15813526|NCT04338009|Other|Discontinuation of ARB/ACEI|The randomized intervention will be the discontinuation of ACEI/ARBs. In all participants randomized to discontinuation, treating clinicians will be reminded about the medication discontinuation upon discharge and will be prompted to consider re-initiation of the medication at that time if appropriate, per the clinician's discretion.
15813527|NCT04338009|Other|Continuation of ARB/ACEI|The randomized intervention will be the continuation of ACEI/ARBs at the doses previously prescribed for patients during their routine care. Clinicians will be encouraged to continue the randomized treatment but will be allowed to change the dose of ACEI/ARB or discontinue these medications if any compelling clinical reasons are identified (such as hypotension, hyperkalemia, acute kidney injury).
15813564|NCT04337710|Procedure|Progressive Enteral Nutrition|Mom's milk or donor milk at 20-30 ml/kg/day after randomization within the first 24 hours.
15813528|NCT04337996|Diagnostic Test|COVID-19 diagnostic test|COVID-19 diagnostic tests performed at day 1 (antigen in blood serum, SARS-Cov2 PCR, antibodies in blood serum) COVID-19 diagnostic test performed at day 21 (antibodies in blood serum)
15813529|NCT04337983|Device|Transpulmonary thermodilution|Obtained by averaging the results of three thermodilution measurements. Each thermodilution is performed by injecting a bolus (15 mL) of cold saline (less than 10°C)
15813530|NCT04337983|Device|Echocardiography|Daily echocardiography evaluation
15813531|NCT04337970|Drug|Talazoparib|"Dose Level 1: 0.5 mg PO daily Dose Level 2: 0.75 mg PO daily Dose Level 3: 1 mg PO daily
~Phase II: MTD to be determined."
15813532|NCT04337970|Drug|Axitinib|5 mg PO BID
15813533|NCT04337957|Other|geriatric nephrology|Collection of the geriatrician's opinion
15813534|NCT04337944|Procedure|Boston keratoprosthesis type 1 and anterior hyaloid membrane peeling assisted by endoscopy|Patients will receive at the same time a Boston keratoprosthesis type 1 (KPro) with a pars plana vitrectomy (PPV) with anterior hyaloid membrane peeling assisted by endoscopy.
15813536|NCT04337918|Drug|NORS (Nitric Oxide Releasing Solution)|NORS treatment will consist of daily self-administration of three routes; Nitric Oxide Gargle (NOG) every morning, Nitric Oxide Nasophyaryngeal Irrigation (NONI) every evening, and Nitric Oxide Nasal Spray (NONS) up to 5 times per day.
15813537|NCT04337918|Drug|NORS (Nitric Oxide Releasing Solution)|"Up to ten volunteers who are found to be COVID-19 positive during screening will be eligible to enroll in the 21-day Treatment sub-study and receive daily NORS treatment for 14 days. NORS treatment will consist of daily self-administration of three routes; Nitric Oxide Gargle (NOG) every morning, Nitric Oxide Nasophyaryngeal Irrigation (NONI) every evening, and Nitric Oxide Nasal Spray (NONS) up to 5 times per day.
~Any participants enrolled in the Prevention study who meet the criteria for the sub study will roll over into the Treatment Sub-Study but must remain in their randomly assigned group."
15813538|NCT04337905|Device|ADHD-VR diagnosis tool|"Since that time and in accordance with the application area, several definitions have been formulated: for example, Fuchs and Bishop (1992) defined VR as real-time interactive graphics with 3D models, combined with a display technology that gives the user the immersion in the model world and direct manipulation; Gigante (1993) described VR as The illusion of participation in a synthetic environment rather than external observation of such an environment. VR relies on a 3D, stereoscopic head-tracker displays, hand/body tracking and binaural sound. VR is an immersive, multi-sensory experience; and Virtual reality refers to immersive, interactive, multi-sensory, viewer-centered, 3D computer generated environments and the combination of technologies required building environments."
15813539|NCT04337892|Device|Standard of Care4|The current standard of care for surgical planning for the participating investigator surgeon is to use Zeiss Veracity Surgical, so this same method will be used for the surgery actually performed on participating patients.
15813540|NCT04337879|Drug|AL2846|AL2846 is a multi-target receptor tyrosine kinase inhibitor, which has obvious selectivity for c-met.
15813541|NCT04337879|Drug|Calcium folate|Calcium folate 400mg/ ㎡ IV on day 1,15 in 28-day cycle
15813542|NCT04337879|Drug|5-FU|5-FU 2800mg/ ㎡ IV on day 1, 2, 15, 16 days in 28-day cycle.
15813543|NCT04337879|Drug|Oxaliplatin|Oxaliplatin 85mg/ ㎡ administered intravenously (IV) on day 1, day 15 in 28-day cycle.
15813544|NCT04337879|Drug|Irinotecan|Irinotecan 180mg/㎡ administered intravenously (IV) on day 1,15 in 28-day cycle.
15813545|NCT04337853|Device|Intraoral stent|Radiotherapy with intraoral stent
15813546|NCT04337853|Other|No intraoral stent|Radiotherapy without intraoral stent
15813547|NCT04337827|Drug|Rituximab|"Weekly x 4 weeks.
~If diagnostic test reveals complete response, then participant will continue with one additional 28 day cycle. If partial response, then proceed with 3 additional 28 day cycles. If stable disease or progression of disease, then go off study treatment and proceed onto Long Term Follow Up (LTFU)."
15813548|NCT04337827|Drug|Acalabrutinib|"100mg twice per day (BID) x 4 weeks (28 day cycle)
~If diagnostic test reveals complete response, then participant will continue with one additional 28 day cycle. If partial response, then proceed with 3 additional 28 day cycles. If stable disease or progression of disease, then go off study treatment and proceed onto LTFU."
15813549|NCT04337827|Diagnostic Test|CT scans|2 weeks (day 36 ± 5 days) after end of cycle 1 treatment.
15813550|NCT04337814|Drug|EMLA Cream|Topical anaesthetic cream
15813551|NCT04337814|Drug|Ibuprofen|Oral analgesic syrup (non-steroidal anti inflammatory drug)
15813552|NCT04337814|Drug|Placebo syrup|Placebo syrup similar to Ibuprofen
15813553|NCT04337814|Drug|Placebo cream|Placebo cream similar to EMLA
15813554|NCT04337801|Other|Acupressure|The acupressure for symptom management is performed by pressing and scrubbing-like manipulations at certain points on the acupuncture meridians.
15813555|NCT04337801|Other|Placebo|The placebo intervention involves touching to the Pericardium 6 and Large Intestine 4 points without pressing.
15813556|NCT04337788|Other|telehealth applications|telehealth applications during 30 days/patient
15813557|NCT04337749|Drug|Chorhexidine scrub|Chorhexidine scrub was given to patients for 2 weeks
15813558|NCT04337749|Device|ZnO-NPs socks|ZnO-NPs socks were given to patients for 2 weeks
15813559|NCT04337749|Combination Product|Combination of chorhexidine scrub and ZnO-NPs socks|Combination of chorhexidine scrub and ZnO-NPs socks were given to patients for 2 weeks
15813560|NCT04337749|Device|Placebo socks|Placebo socks were given to patients for 2 weeks
15813561|NCT04337736|Other|Physical exercise|
15813562|NCT04337723|Behavioral|ABI/WIFI scoring|The initial ABI training workshop will be coordinated by the non-physician clinic staff champion, and all non-provider clinic staff will be asked to participate. The PI and a research assistant will conduct a 1.5-hour telemedicine training session instructing clinical staff in ABI measurement and WIfI and scoring, using the clinical scoring sheet. Following didactic teaching, participants will perform ABI tests under the guidance of the PI/research assistant and with the support of other participants. During each part of the workshop, specific attention will be directed to pitfalls and technical errors of the test. A pre-post assessment will be used to ensure comprehension of key concepts and performance of the ABI and WIfI tools.
15813563|NCT04337710|Procedure|Exclusive Enteral Nutrition|Mom's milk or donor milk at 60-80 ml/kg/day after randomization within the first 24 hours.
15813565|NCT04337684|Drug|Long Term Follow-Up|"Menkes disease is a form of inherited copper deficiency associated with neurodevelopmental delays and neurological problems. Copper Histidinate is being evaluated for efficacy and safety in patients with Menkes disease. The purpose of this protocol is to collect long term follow-up data.
~During the study, patients and/or parent/legal guardian will be contacted by the investigator by either telephone or an in-person visit to assess long term follow-up."
15813566|NCT04337671|Other|Moderate intensity aerobic training|"The exercise program consisted of 5 minutes warm-up, 15-30 minutes of moderate aerobic exercises and 10 minutes cool-down, respectively.
~Frequency: 3 sessions/week , and Duration:12 weeks."
15813567|NCT04337658|Drug|Pertuzumab|Participants will receive 840 milligrams (mg) loading dose of pertuzumab, followed every 3 weeks thereafter by a dose of 420 mg via intravenous (IV) infusion until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
15813568|NCT04337658|Drug|Trastuzumab|Participants will receive trastuzumab (8 mg/kg loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles) administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
15813569|NCT04337658|Drug|Fulvestrant|500mg intramuscular injections at day 1, 15, 28 and 4 weeks thereafter
15813570|NCT04337658|Drug|Capecitabine|1000mg/m2 orally Bid on day 1 to day 14 every 3 weeks until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
15813571|NCT04337645|Procedure|surgical treatment of peri-implantitis|resective surgical treatment of peri-implantitis
15813572|NCT04337632|Drug|Doxorubicin Hydrochloride Liposome Injection+carboplatin|Doxorubicin Hydrochloride Liposome Injection 25mg/m2, carboplatin AUC 5, first day, intravenous drip, repeated every three weeks.
15813573|NCT04337632|Drug|paclitaxel +carboplatin|paclitaxel 175mg/m2, carboplatin AUC 5, day 1, intravenous infusion, repeated every three weeks.
15813574|NCT04337619|Behavioral|Behavioral Treatment|Standard Behavioral Weight Loss Treatment (remotely delivered)
15813575|NCT04337619|Behavioral|Mindful Acceptance|Integration of acceptance and willingness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
15813576|NCT04337619|Behavioral|Values|Integration of values clarification and awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
15813577|NCT04337619|Behavioral|Mindful Awareness|Integration of mindfulness and present-moment awareness skills into Standard Behavioral Weight Loss Treatment (remotely delivered).
15813578|NCT04337606|Drug|Chidamide|Chidamide is a novel and orally active benzamide class of HDAC inhibitor that selectively inhibits activity of HDAC1, 2, 3 and 10, which can Induce tumor-cell apoptosis, suppress cell proliferation and enhance immune surveillance; Decitabine is an investigational (experimental) drug that works by depleting DNA methyltransferase 1(DNMT1), which can increase tumor antigens and HLA expression, enhances antigen processing, promotes T cell infiltration, and boosts effector T cell function.
15813579|NCT04337606|Drug|Decitabine|Decitabine is an investigational (experimental) drug that works by depleting DNA methyltransferase 1(DNMT1), which can increase tumor antigens and HLA expression, enhances antigen processing, promotes T cell infiltration, and boosts effector T cell function.
15813580|NCT04337606|Drug|Camrelizumab|Camrelizumab is a humanized anti-PD-1 monoclonal antibody.
15813581|NCT04337593|Drug|Basiliximab|20mg d1,8, repeated every 3 weeks
15813582|NCT04337593|Drug|Pegaspargase|2500IU/㎡, d1,repeated every 3 weeks
15813583|NCT04337580|Drug|Omeprazole 80 mg twice daily|Participants will be treated with omeprazole 80 mg twice daily on Day 0. Within 10 days of starting omeprazole, participants will be treated with standard prostate cancer dosing of every three week docetaxel or cabazitaxel based on package insert. Participants that have only had docetaxel will be retreated with docetaxel along with concurrent omeprazole. Patients that have had both docetaxel and cabazitaxel will be retreated with either cabazitaxel or docetaxel (investigators choice) along with concurrent omeprazole. However investigators encourage investigator to choose cabazitaxel in patients previously treated with cabazitaxel.
15813584|NCT04337567|Procedure|radiofrequency ablation|ablative treatment as allocated to radiofrequency ablation
15813585|NCT04337567|Procedure|ballon cryoablation|ablative treatment as allocated to ballon cryoablation
15813586|NCT04337554|Device|Exoskeleton footwear|Assistive footwear
15813587|NCT04337541|Other|Surgical facial mask|Participants will follow normal Authority recommendations AND wear mask outside their homes, or when receiving visits in their home.
15813588|NCT04337528|Other|Osteopathic manipulation type thrust|The osteopathic manipulation type thrust is applied to solve the sacroiliac joint dysfunction. This technique applies a high velocity and intensity push in a specified direction to correct the dysfunction produced by a not correct position or movement of one joint.
15813589|NCT04337528|Other|Osteopathic manipulation type muscle-energy|The muscle-energy manipulation is applied to solve the sacroiliac joint dysfunction. This technique applies a movement with an intermittent resistance in a specified direction to correct the position or movement of one joint. The therapist applies the movement in the correct direction since he feels a limitation of movement. When he feels the limitation he requests to the participant pushing in the contrary direction without movement. After five or seven seconds the participant finishes the contraction and the therapist continues the correct movement since he feels once again the limitation, and he request to the participant contraction another five or seven seconds. The therapist request to the participant only three times, when he finish the three contraction and the therapy applies the last movement to correct direction the intervention finishes.
15813590|NCT04337528|Other|Placebo technique|The therapist simulates a false technique. The therapist applies movement in the sacroiliac joint without dysfunction, he applies movement since ninety degrees of pelvic flexion, and he wait sixty seconds. Whit this placebo technique the sacroiliac joint with the dysfunction is not altered.
15813591|NCT04337515|Device|CliniMacs®|CliniMACS® CD34 Reagent System is now indicated for processing hematopoietic progenitor cells collected by apheresis (PBSC) from an allogeneic, HLA-identical MSD to obtain a CD34+ cell-enriched population for hematopoietic reconstitution following a myeloablative preparative regimen without the need for additional GVHD prophylaxis in patients with AML in first morphologic complete remission (CR1).
15813592|NCT04337502|Diagnostic Test|Machine learning model|Machine learning, such as logistic regression, random forest, and deep learning
15813593|NCT04337489|Device|SensiumVitals wearable sensor|A waterproof, light, wearable sensor measuring vital signs (heart rate, respiratory rate, temperature) continuously.
15813594|NCT04337476|Device|The effects of Pacifier Activated Lullaby in very low birth weigt preterm infants. An italian music therapy intervention|Positive reinforcement is an effective development strategy for improving the feeding skills of preterm infants. A brief intervention with the PAL device with pacifier that reproduces lullabies sung by both parents or by the music therapist could reduce the use of the feeding tube and the length of hospital stay in preterm infants. The aim of this study is not only to evaluate the benefits of positive reinforcement on the nutritional sucking competence of the premature baby, but at the same time to observe its possible effects on its well-being and its clinical stability.
15813595|NCT04337463|Drug|ATG-008|Tablet
15813596|NCT04337463|Drug|Toripalimab|IV infusion
15813597|NCT04337450|Drug|Dolutegravir (DTG) and lamivudine (3TC)|Children randomised to the DTG/3TC arm will receive once daily DTG/3TC fixed dose combination dispersible or film-coated tablets dosed using WHO weight bands criteria
15813598|NCT04337450|Drug|SOC|2 nucleos(t)ide reverse transcriptase inhibitor (NRTI) and a third (anchor) drug (either an integrase strand transfer inhibitor (INSTI), a protease inhibitor (PI) or a non- nucleoside reverse transcriptase inhibitor (NNRTI)
15813599|NCT04337437|Drug|Genakumab|150 mg/1ml/bottle, single subcutaneous injection.
15813600|NCT04337437|Drug|Placebo for this trial|The placebo contains other excipients except Genakumab, and its appearance is consistent with that of Genakumab for injection, 150 mg/1ml/bottle, single subcutaneous injection.
15813601|NCT04337424|Diagnostic Test|Sampling salivary|Collection of 1 to 2 ml of saliva
15813602|NCT04337411|Other|Follow-up assessments|Longitudinal evaluation of recovery
15813603|NCT04337398|Behavioral|Exercise training for 12 weeks (wearables)|Activity trackers with adaptive weekly step goals, weekly walking groups and coaching.
15813604|NCT04337398|Behavioral|Exercise training for 12 weeks (wearables and exergames)|Activity trackers with adaptive weekly step goals, weekly walking groups, coaching and exercise programme based on exergames (aerobic, resistance and stretching training three weekly group sessions).
15813605|NCT04337385|Behavioral|Interrupting 3 hours of prolonged sitting with high intensity interval exercise|Breaking up a prolonged bout of sitting in adolescents using high intensity interval exercise
15813606|NCT04337385|Behavioral|3 hours of prolonged sitting|Participants will be asked to remain seated for 3 hours and refrain from moving their lower limbs
15813607|NCT04337372|Behavioral|Book reading|Parent and their infant will read a short book in the laboratory. Books will include three labeling conditions expected to elicit different levels of attention.
15813608|NCT04337359|Drug|Ruxolitinib|5 mg. Tablet
15813609|NCT04337333|Device|Two-in-one stent|Endoscopic placement of a Two-in-one metal stent into extrahepatic bile duct
15813610|NCT04337320|Other|newborns from covid 19 positive mothers|Evaluation of apgar, hemogram and developmental status of babies born from covid 19 positive mothers
15813611|NCT04337307|Biological|Skin sampling of the hands of the healthcare workers involved in the decontamination of incubators|"Each incubator will be sampled in 5 points before and after decontamination. The healthcare worker that will be involved in the decontamination will also be sampled (skin sample of the hand) before and after decontamination of the incubator.
~All the samples will be analyzed for the presence of pathogenic bacteria, using an inoculation on selective agar then an identification of each bacterial colony."
15813612|NCT04337268|Drug|Glucagon-Like Peptide 1|Intravenous infusion (1.5 pmol/kg/min) for 60 min.
15813613|NCT04337268|Drug|saline 0.9%|Intravenous infusion for 60 min.
15813614|NCT04337255|Other|Behavioral Dietary intervention ( MIND Diet)|The MIND diet is a hybrid of the Mediterranean and DASH diets but with selected modifications based on the most compelling evidence in the diet dementia field. The MIND diet has the same basic components of the DASH and Mediterranean diets, such as emphasis on natural plant based foods and limited animal and high saturated fat foods, but uniquely specifies green leafy vegetables and berries as well as food component servings that reflect the nutrition dementia evidence.
15813615|NCT04337255|Other|Behavioral Usual Care Diet Intervention|The Usual Care diet is comprised of both westernized (e.g. Steak, Mac n Cheese) and healthy ( veggie chili) food components
15813616|NCT04337242|Behavioral|B-DIT|Blended Dynamic Interpersonal Therapy
15813617|NCT04337242|Behavioral|B-CBT|Blended Cognitive Behavioral Therapy
15813618|NCT04337242|Behavioral|DIT|Dynamic Interpersonal Therapy
15813619|NCT04337242|Behavioral|Cognitive Behavioral Therapy|CBT
15813620|NCT04337229|Other|Artifical intelligent|it is planned to create a technology that determines the comfort level of the newborn quickly and simply, easy to use, time-saving and can be used by the mobile device.
15813621|NCT04337203|Behavioral|SHARE-S Implementation Program|The program consists of three components: An electronic referral among clinical teams for potential participants, patient engagement with survivorship care planning guidelines through self-management/health coaching. One coaching call before a clinic visit (60 minutes) and two coaching calls after the clinic visit (30 minutes each). Participants will also receive automated, tailored text messages (daily for three weeks before and after a clinic visit for a total of six weeks).
15813622|NCT04337190|Biological|blood sampling|blood sampling at the day of admission, day 3 and day 7
15813623|NCT04337177|Drug|VAL-413|a flavored preparation of orally administered irinotecan
15813624|NCT04337177|Drug|Temozolomide|alkylating oral chemotherapy agent used to treatment brain cancers
15813625|NCT04337151|Device|MAGEC Spine Rod|Magnetically controlled growing spine rod used for the surgical treatment of scoliosis.
15813626|NCT04337151|Diagnostic Test|Titanium blood test|A blood test captured to measure the level of titanium
15813627|NCT04337138|Drug|Gemtuzumab Ozogamicin|Gemtuzumab Ozogamicin (Mylotarg) administered in any form or combination
15813628|NCT04337125|Other|Neuropsychological and attachment/parenting assessment|"Children assessments:
~Mental health assessment, Intellectual functioning assessment, Sleep patterns assessment, Behavior assessment, Severity of ADHD symptoms assessment, child attachment assessment, parenting practices assessment, emotional regulation assessment, Direct measures of attention and executive functions assessment, Indirect measures of attention and executive functions assessment
~Parents assessments:
~Mental health assessment, Intellectual functioning assessment, ADHD symptoms assessment, Depression symptoms assessment, Attachment style assessment, Direct measures of attention and executive functions assessment, Indirect measures of attention and executive functions assessment."
15813630|NCT04337099|Drug|MBM-02 (Tempol)|Study drug will be administered orally using the capsule formulation (200 mg). The study drug will be administered 7 days a week for the entire treatment period.
15813631|NCT04337086|Device|T4k Appliance|The pre-fabricated, hard, polyurethane, pink T4K™ (Myo functional research Co., Australia) was used in the study. It consisted of: facial bows, lingual bows / tongue guard, lingual tag / tongue tag, dental channels with a pre-determined bite position and a lip bumper. In the first week, the patients were instructed to gradually increase the wearing time of the appliance during the daytime. By the second week, the patients were instructed to wear the appliance achieving at least 8 hours during sleeping. The Trainer usually needs no adjustments. The patients were asked to place it themselves inside their mouths. The distal ends of the appliance were trimmed 2-3 mm with an acrylic bur on a straight hand piece if they were too long or the patient could not keep his lips together. By the end of the first 4 weeks, the patients were wearing the appliances minimum of 1 hour during the day plus the overnight wear following the manufacturer's instructions.
15813632|NCT04337086|Device|Twin block appliance|The twin block was used, and instructions were given to wear the appliance nearly full-time. Selective sequential inter-occlusal trimming was done monthly after the 2nd month in the occlusal surface of the maxillary bite blocks to clear over the mandibular molars allowing their eruption in a more favourable mesial direction and to increase the vertical dimension. Trimming was done in the fitting surface over the maxillary and mandibular premolars whenever needed to allow their full eruption and to level the occlusal plane
15813633|NCT04337073|Drug|Propofol|Before anesthesia induction, M group received intravenous injection of 0.3mg/kg Propofol, while N group received corresponding intravenous normal saline of the same volume. After 1 min, both groups received intravenous injection of dexamethasone sodium phosphate injection of 10mg.
15813634|NCT04337073|Drug|normal saline|Before anesthesia induction, M group received intravenous injection of 0.3mg/kg Propofol, while N group received corresponding intravenous normal saline of the same volume. After 1 min, both groups received intravenous injection of dexamethasone sodium phosphate injection of 10mg.
15813635|NCT04337060|Procedure|Single-injection ultrasound-guided bilateral erector spinae plane (ESP) block-Sham|"With the patient in the sitting position, 20 ml normal saline will be administered between the T11 spinous process and the erector spinae muscles with the guidance of an ultrasound probe placed on a parasagittal plane.
~Intraoperative analgesia: after anesthesia induction, paracetamol 1 gr intravenous (IV)+ tenoxicam 20 mg IV + morphine 0.05 mg/kg IV (max 4 mg).
~Postoperative analgesia: IV morphine patient-controlled analgesia (PCA) of 0.5 mg/ml morphine (demand dose 1 mg; lockout interval 8 m; 6 mg/h limit)."
15813636|NCT04337060|Procedure|Single-injection ultrasound-guided bilateral erector spinae plane block-Lidocaine/Bupivacaine|"With the patient in the sitting position, 10 ml 1% lidocaine + 10 ml 0.5% bupivacaine will be administered between the T11 spinous process and the erector spinae muscles with the guidance of an ultrasound probe placed on a parasagittal plane.
~Intraoperative analgesia: After anesthesia induction, paracetamol 1 gr IV + tenoxicam 20 mg IV + morphine 0.05 mg/kg IV (max 4 mg).
~Postoperative analgesia: IV PCA of 0.5 mg/ml morphine (demand dose 1 mg; lockout interval 8 m; 6 mg/h limit)."
15813637|NCT04337060|Other|Pain follow-up and monitorization|Numeric Rating Scale (NRS) pain score will be recorded from 15th minute in recovery room followed by 1.-3.-6.-12.-18.-24.hours with two different conditions which are at rest and while couching.If NRS score becomes ≥4 Dexketoprofen 50 mg will be administered (max 4 times).
15813638|NCT04337047|Other|questionnaire assesment|questionnaire assesment
15813639|NCT04337034|Behavioral|Mobile phone supported and family-centred rehabilitation|Participants in the intervention group will receive an eight-week mobile phone supported and family-centred rehabilitation intervention (F@ce 2.0).The participants will be introduced to a problem-solving strategy intended to facilitate the learning and problem-solving process to be used during the intervention. The strategy will provide a structure for healthcare professionals delivering the intervention. Three targets (goals) in daily activities will be formulated that the person wants and needs to do within the home environment. Each activity will be practiced together with the healthcare professionals and family members. Family members will be informed about the participant's target activities and the planned strategies for reaching the targets. The participants will practice the target activities in their home environment supported by mobile phone calls and SMS. In addition they will be given information about stroke and their blood pressure will be measured.
15813640|NCT04337034|Procedure|Information and blood pressure measurement|Control group participants will be given information about stroke and their blood pressure will be measured.
15813641|NCT04337021|Behavioral|Caregiver SOS|SOS care is brief, telephonic care (6 one-hour sessions over 3-4 months) tailored to the CG's needs, preferences, and priorities. SOS care addresses both work and caregiving stress. The five pillars of behavior change in SOS care are: 1) knowledge of work and CG stress; 2) stress management skills and abilities; 3) supports and resources; 4) confidence and motivation to modify stress; and 5) work and CG-focused problem-solving skills. The pillars are addressed through seven modules. In six sessions, the CM will cover each module at least once. SOS care involves an ongoing process of formulating self-management goals and action plans and preparing CGs to succeed in implementing them. Addressing both work and caregiving contexts, CMs will educate CGs about stress. CMs introduce strategies for self-managing stress and collaboratively design experiments to test these strategies. The CG's progress is monitored to identify strategies that effectively achieve self management goals.
15813642|NCT04337008|Other|blood draw|20 mL blood draw will be performed at J1 et J7
15813643|NCT04336995|Diagnostic Test|contrast echocardiography|giving echocardiographic contrast and taking echocardiographic images before and after exercise
15813648|NCT04336969|Behavioral|4T Education and Care|CGM data will be used to create customized weekly feedback to the participant/family by secure MyChart message.
15813649|NCT04336956|Other|hospitalized children with Covid19|All patients under 18 years hospitalized with a covid19 diagnosis
15813650|NCT04336943|Biological|Durvalumab|Given IV
15813651|NCT04336943|Drug|Olaparib|Given PO
15813652|NCT04336943|Other|Quality-of-Life Assessment|Ancillary studies
15813653|NCT04336943|Other|Questionnaire Administration|Ancillary studies
15813654|NCT04336930|Diagnostic Test|Pupillary pain index (PPI)|Measurement of PPI with a pupillometer
15813655|NCT04336917|Drug|Rhomboid Intercostal and Subserratus Plane Block with local anesthetic|Local anesthetic will be injected in the tissue planes between the rhomboid and the intercostal muscles and the serratus anterior and external intercostal muscles with ultrasound guidence.
15813656|NCT04336904|Drug|Favipiravir|"Dosage and method of administration: Day 1: 1800mg, BID; Day 2 and thereafter: 600mg, TID, for a maximum of 14 days.
~Where the subject has experienced an adverse event related to liver injury of grade≥3 (NCI CTCAE v5.0), the dose is to be reduced to 600mg BID. It is at the discretion of the investigator whether or not to perform dose reduction based on how the subject is benefiting from study treatment. The subject should be discontinued from treatment if he/she re-experiences any adverse event related to liver injury of grade≥3 after dose reduction"
15813657|NCT04336904|Other|Placebo|"Dosage and method of administration: Day 1: 1800mg, BID; Day 2 and thereafter: 600mg, TID, for a maximum of 14 days.
~Where the subject has experienced an adverse event related to liver injury of grade≥3 (NCI CTCAE v5.0), the dose is to be reduced to 600mg BID. It is at the discretion of the investigator whether or not to perform dose reduction based on how the subject is benefiting from study treatment. The subject should be discontinued from treatment if he/she re-experiences any adverse event related to liver injury of grade≥3 after dose reduction"
15813658|NCT04336891|Drug|Testosterone gel|Transdermal 2% T gel applied once daily to the thighs or lower abdominal/pubic area (300 mcg T per day) for 6 months
15813659|NCT04336891|Drug|Estradiol ovules|Intravaginal estradiol ovules taken daily for 2 weeks and afterwards twice a week, for 6 months
15813660|NCT04336891|Drug|Moisturizer|Local non-hormonal moisturizers applied regularly every 2-3 days and lubricants as needed
15813661|NCT04336891|Drug|Testosterone gel + Estradiol ovules|Transdermal 2% T gel applied once daily to the thighs or lower abdominal/pubic area (300 mcg T per day), plus Intravaginal estradiol ovules taken daily for 2 weeks and afterwards twice a week, for 6 months
15813662|NCT04336878|Behavioral|Healthy Habits in Pregnancy and Beyond|Habit-based intervention to support the development of 10 healthy dietary and activity behaviours for pregnant women with overweight or obesity.
15813663|NCT04336852|Procedure|Flow mediated dilation (brachial and femoral arteries)|Assessment of vascular function of the brachial and femoral arteries.
15813664|NCT04336852|Procedure|Cerebral vascular reactivity to carbon dioxide (CO2)|Cerebral blood flow responses to increasing partial pressure of CO2
15813665|NCT04336852|Procedure|Cerebral vascular function test|Cerebral blood flow responses to a reactive hyperemia stimulus
15813666|NCT04336839|Procedure|Portal vein resection / reconstruction|Portal vein resection and reconstruction, with or without concommitant arterial resection
15813667|NCT04336826|Drug|Ataluren|Ataluren will be administered as per the dose and schedule specified in the arm.
15813668|NCT04336813|Other|Audience Response system|In the lecture hall, G1 was separated from G2, and both groups completed an assessment of written multiple-choice questions (MCQs) scored out of 20, before the lecture. During L1, phone based (ARS) questions (PB-ARS) secretly displayed on the smart phones of the students in G1, and they were allowed to read the question and answer it, while those in parallel arm of the trial (G2) were blinded to those questions and answers. At the end of L1, both groups completed the same written MCQs assessment
15813669|NCT04336800|Device|LiverMultiscan|The LiverMultiscan is a quick 15 min, contrast free scan that non-invasively provides three metrics of liver health namely liver fat, iron and fibro-inflammation
15813670|NCT04336787|Other|Survey|A Google Survey which included that consent form, demographic information form, International Physical Activity Questionnaire, Pittsburgh Sleep Quality Index, Perceived Stress Scale and The Numeric Rating Scale will be created. Then the survey link will be shared via social media such as Whatsapp, Facebook, etc.
15813671|NCT04336774|Device|Caption AI|Software program that guides the investigator or any other non-sonographer to take the best possible pictures of the heart.
15813672|NCT04336761|Diagnostic Test|nasopharyngeal swab|Data collection and nasopharyngeal swab
15813673|NCT04336748|Drug|Hydroxychloroquine|low dose (200mg) Hydroxychloroquine once daily for 4 weeks
15813674|NCT04336735|Other|immunization app|A transplant specific immunization app will be trialed that 1) provides vaccine information and education, 2) stores vaccine records and 3) provides reminders when vaccines are due
15813677|NCT04336709|Drug|Calcipex II|Water based intracanal medicament
15813678|NCT04336709|Drug|Metapex|Oil based intracanal medicament
15813679|NCT04336696|Procedure|Total thyroidectomy and central neck dissection|
15813680|NCT04336683|Device|Interstitial and intracavitary brachytherapy|Standard of care in interstitial or intracavitary brachytherapy is to insert the brachytherapy needle and applicator with no standard real-time image guidance. Interstitial brachytherapy is done under general anesthesia. Trans-abdominal and trans-rectal standard 2D ultrasound is used in some cases, but is typically not consistent and therefore its value is limited. Pre-procedure imaging in the form of MRI is used to help guide needles insertion as well as the clinical exam. Post-procedure CT is done for radiation planning
15813681|NCT04336670|Device|Immersive Virtual Reality exercise program|One session with an exercise program focused in upper and low limbs movements in a virtual enviroment, all performed in standing position.
15813682|NCT04336670|Other|Exercise therapy|Usual center therapies (Physical therapy, occupational therapy..)
15813683|NCT04336657|Other|Questionnaire|Survey to identify number of people who got unusual severe flu- like illness in last October- November
15813684|NCT04336657|Diagnostic Test|IgG|Measure the past immunity of the disease (if possible)
15813685|NCT04336644|Device|BodyGuardian Heart|The BodyGuardian Heart attaches to the upper chest of the patient through the use of an adhesive patch. ECG tracings are recorded continuously and sent to the linked smartphone and subsequently to a cloud server.
15813686|NCT04336631|Behavioral|Intervention on DCP3 based strategies for Hypertension Management and Control|Intervention on DCP3 based strategies for Hypertension Management and Control was developed after formative research findings and evidence built on desk review which was conducted prior to implementation of the multi-componnet strategy. It was tested and implemented in a tertiary care hospital of cardiology among hypertensive patients visiting out-patient department in Rawalpindi, Pakistan.
15813687|NCT04336618|Device|Liver MultiScan|The LiverMultiscan is a quick 15 minute, contrast free, non-invasive MRI scan that provides 3 liver metrics
15813688|NCT04336605|Other|Age & Development|Age, sex, pubertal onset and development
15813689|NCT04336605|Other|Socioeconomy|Family structure and economy
15813690|NCT04336605|Other|Traumatic Events|Violence and other traumatic events
15813691|NCT04336605|Other|Psychosocial conditions|Family/social support
15813692|NCT04336605|Other|Lifestyle|Physical activity, BMI, nutrition, smoking …
15813693|NCT04336605|Other|Chronic conditions|I.e. Epilepsy or juvenile rheumatoid arthritis ...
15813694|NCT04336605|Other|Somatic symptoms|Headache, pain, sleep disturbances ...
15813695|NCT04336605|Other|Psychological symptoms|PTSS, anxiety, depressive symptoms & loneliness ...
15813696|NCT04336605|Other|Non-prescription analgesics|Non-prescription analgesics
15813697|NCT04336605|Other|Prescription drugs|Analgetic, sedative & anxiolytic medication
15813698|NCT04336592|Behavioral|Non-pharmacological Options in post-operative Hospital and Rehabilitative Management (NOHARM)|Gathers patient preferences for non-pharmacological pain management strategies through medical record and inform clinicians (via prompts, orders, etc.) of these preferences and encourages conversation about these preferences throughout their routine pre- and post-surgical interactions with patients. Resources will be provided to bedside clinicians as they assist patients in identifying a personalized post-discharge pain management strategy.
15813699|NCT04336579|Behavioral|Diaphragmatic Breathing|Simple diaphragmatic breathing exercise
15813700|NCT04336566|Dietary Supplement|Melatonin|Melatonin 5mg
15813701|NCT04336566|Dietary Supplement|Placebo|Comparable Good Neighbor Pharmacy placebo tablet
15813702|NCT04336553|Behavioral|Social prescribing in Sweden (SPiS)|Social prescribing in sweden (SPiS)
15813703|NCT04336540|Other|Menu configuration (presence of energy labelling)|Restaurant menus are altered to accommodate energy labelling intervention
15813704|NCT04336540|Other|Menu configuration (more lower energy options added)|Restaurant menus are altered to include more lower energy options
15813705|NCT04336527|Behavioral|Home Treatment with Peer Support|After allocation participants receive a combination of Home Treatment by a multiprofessional team and Peer Support.
15813706|NCT04336527|Behavioral|Home Treatment without Peer Support|After allocation participants receive professional-led Home Treatment by a multiprofessional team without Peer Support (treatment as usual).
15813707|NCT04336514|Device|Semi-compressed felt pad (SCF)|Participants with forefoot callus will receive routine treatment of debridement of callus. Along with the debridement, a Plantar Metatarsal Pad (PMP) made of Semi-Compressed Felt (SCF) with appropriate cut outs will be placed in their shoes. The thickness of the SCF would be selected based on the patient weight, and appropriateness of the thickness would be confirmed by the Medilogic pressure measurement. A 50% pressure reduction is the desired outcome.
15813708|NCT04336501|Biological|IM19 CAR-T|All patients will be treated with fludarabine and cyclophosphamide for 3 days,then,CAR-T cells expressing CD19 CAR will be infused 24-96 hours later
15813709|NCT04336488|Drug|Matrix Metalloproteinase Inhibitors (Orochem)|topical application of MMP inhibitors for 3 weeks to evaluate its effectiveness in treating oral lichen planus
15813710|NCT04336488|Drug|Kenacort A,|topical application of both drugs 3 times daily for 3 weeks as an active control
15813711|NCT04336475|Other|orofacial exercise program|combined stretching&strengthening exercise regimen
15813712|NCT04336462|Device|oxyhydrogen|Hydrogen-Oxygen Generator with Nebulizer Model: AMS-H-03 Gas production: 2.0 L/min, 2.5 L/min, and 3 L/min, three gears in total (in this study, the gas production of each machine is 3 L/min, two sets are connected and used together by three-way connection, and the total gas production is 6 L/min.) Manufacturer: Shanghai Asclepius Meditech Co., Ltd.
15813713|NCT04336462|Device|Oxygen|oxygen inhaled,3 L/min . 6 hour a day.
15813714|NCT04336449|Drug|Eptinezumab|Eptinezumab - single intravenous infusion
15813715|NCT04336449|Drug|Placebo|Placebo - single intravenous infusion
15813716|NCT04336436|Behavioral|Mindfulness training|Mindfulness training
15813717|NCT04336436|Behavioral|Nutritional consult|Nutrition counseling and development of a personalized nutrition plan
15813718|NCT04336423|Diagnostic Test|Obtain samples from sputum and feces|Samples are obtained from participants. No further intervention is required. Obtained samples will be further analyzed.
15813719|NCT04336410|Drug|INO-4800|INO-4800 will be administered ID on Day 0, Week 4 and at the optional Booster Dose Visit.
15813720|NCT04336410|Device|CELLECTRA® 2000|EP using the CELLECTRA® 2000 device will be administered following ID delivery of INO-4800 on Day 0, Week 4 and at the optional Booster Dose Visit.
15813721|NCT04336397|Diagnostic Test|multi-target stool DNA test|Cluster randomized trial of high and medium intensity outreach with MT-sDNA compared with usual care
15813723|NCT04336358|Other|Telemedicine|Telemedicine consultation online
15813724|NCT04336332|Combination Product|Hydroxychloroquine Sulfate + Azithromycin|Given PO
15813725|NCT04336332|Drug|Hydroxychloroquine Sulfate|Given PO
15813726|NCT04336319|Biological|Fecal Microbial Transplantation|"At baseline, the fecal fluid from 3 different donors, 150 ml, will be delivered via pouchoscopy after which the patient will roll in to the right lateral position and stay in that position for at least 15 minutes. Prior to the procedure, the patient will fast for 12 hours and preform two fleet enemas as preperation.
~FMT at 7 days and 4 weeks will be delivered via ingestion of 15 capsules containing 650 µL of fecal fluid from 3 different donors (the same three donors as at baseline)."
15813727|NCT04336306|Other|virtual reality-based therapy (VRBT)|"The warm-up was performed using the Just Dance 2015 game, in a sequence previously defined in a pilot study, aiming to increase HR progressively. A multimedia projector (Epson Power Life, H309A, China) connected to a console (Xbox One KinectTM, Microsoft, Redmond, WA) was used to project the game onto a white wall.The conditioning phase was performed using the Shape Up exercise game, in which patients perform exercises following a virtual therapist."
15813728|NCT04336293|Device|sTMS|"sTMS will be delivered following NeoSync guidelines using the device user
~manual"
15813729|NCT04336293|Device|sham sTMS|sham sTMS will be delivered following NeoSync guidelines using the device user manual
15813730|NCT04336280|Other|Symptom questionnaire|Arabic version of the International Prostate Symptom Score: Known and validated questionnaire to quantify and qualify the severity of symptoms of the lower urinary tract
15813731|NCT04336280|Diagnostic Test|Urodynamics|Urodynamics: the standard diagnostic tool, it includes invasive recording of the pressure that is produced when the bladder muscle contracts via pressure sensors introduced in the urinary bladder through special types of urethral catheters.
15813732|NCT04336267|Device|Transcranial direct current stimulation (tDCS) group|Patients randomized to the tDCS group were treated with the following parameters: duration of stimulation of 20 minutes per session with a 2 mA intensity of anodal stimulation.
15813733|NCT04336267|Device|Sham group|In the sham group, the stimulation setting was exactly the same but the stimulation intensity was set according to a ramping up/ramping down method and delivered only in the first and last 30 seconds of each session.
15813734|NCT04336254|Biological|allogeneic human dental pulp stem cells (BSH BTC & Utooth BTC)|Intravenous injection of 3.0x10e7 human dental pulp stem cells solution (30ml) on day 1, day 4 and day 7, based on routine treatment of COVID-19
15813735|NCT04336254|Other|Intravenous saline injection (Placebo)|Intravenous injection of 3ml of 0.9% saline on day 1, day 4 and day 7, based on routine treatment of COVID-19
15813736|NCT04336241|Biological|RP2|Genetically modified herpes simplex type 1 virus for tumor lysis and immune stimulation
15813737|NCT04336241|Biological|nivolumab|Programmed death receptor (PD-1) blocking antibody
15813738|NCT04336228|Drug|Escitalopram|20mg daily for 3-4 weeks.
15813739|NCT04336228|Drug|Placebo oral tablet|20mg placebo tablet daily for 3-4 weeks.
15813740|NCT04336215|Other|Non-Interventional|This non-interventional study poses no additional risks to people with pre-existing conditions.
15813741|NCT04336202|Radiation|External beam radiotherapy + Endorectal brachytherapy|In this study, all participants will receive a treatment of external beam radiotherapy without chemotherapy, which will be followed by three (3) treatments of endorectal brachytherapy with the new applicator.
15813742|NCT04336189|Drug|Sulfadoxine-pyrimethamine (SP)|SP (Kamsidar) will be supplied by Kampala Pharmaceutical Industries (KPI), Uganda. SP will be given as a single dose consisting of 3 full strength tablets.
15813743|NCT04336189|Drug|Dihydroartemisinin-piperaquine (DP)|DP (Duo-Cotecxin) will be supplied by Holley-Cotec, Beijing, China. DP will consist of 3 full strength tablets given once a day for 3 consecutive days.
15813744|NCT04336176|Device|PulseFlow DF boot|Offloading boot
15813745|NCT04336176|Device|Usual standard of care|Usual standard of care (offloading device)
15813746|NCT04336176|Device|Sham|Sham shoe (closest to barefoot or baseline pressures)
15813747|NCT04336163|Device|Optical Coherence Tomography|Skin imaging to determine vascular characteristics such as plexus depth, vessel diameter, and vessel density.
15813748|NCT04336150|Other|Hypopressive exercises|See information included in arm/group descriptions.
15813749|NCT04336150|Other|Hypopressive maneuver|See information included in arm/group descriptions.
15813750|NCT04336150|Other|Hypopressive exercises plus pelvic floor muscle contraction|See information included in arm/group descriptions.
15813751|NCT04336150|Other|Hypopressive maneuver plus pelvic floor muscle contraction|See information included in arm/group descriptions.
15813752|NCT04336124|Drug|CVM-1118 Extended-Release (ER) Capsules (200 mg/capsule)|"Patients will receive initial dose regimen: 400 mg of CVM-1118 ER Capsule per day (200 mg BID) in a 28-day cycle for 4 cycles.
~Dose escalates from 400, 600, 800, to 1200 mg of CVM-1118 ER capsules with either BID or TID dosing.
~A single-patient cohort per dose level (accelerated titration design) will be applied to the first two cohorts, 400 and 600 mg daily, and followed by the conventional 3+3 dose escalation design from the dose level of 800 mg/day.
~If 2 or more patients experience a DLT, no further dose escalation will occur."
15813753|NCT04336111|Procedure|retrolaminar block|will receive real bilateral bilevel ultrasounded guided retrolaminar block at T4 and T10 after induction of anaesthesia in prone position. The total desired volume used in the whole injection will be 40 ml containing 3mg / kg bupivacaine with adrenaline 2.5 2 µg/ml. The total 40 ml volume will be divided into 10 ml for each injection.
15813754|NCT04336098|Drug|SRF617|SRF617 prevents CD39 mediated conversion of adenosine triphosphate (ATP) and adenosine diphosphate (ADP) to adenosine monophosphate (AMP) and phosphate, leading to an increase in extracellular ATP and a reduction in adenosine levels within the tumor microenvironment (TME). There is an important role for extracellular ATP and adenosine in cancer maintenance and progression, and maintaining high levels of ATP (and low levels of adenosine) in the TME may have anticancer therapeutic activity.
15813755|NCT04336098|Drug|Gemcitabine|Gemcitabine as an intravenous (IV) infusion
15813756|NCT04336098|Drug|Albumin-Bound Paclitaxel|Albumin-bound paclitaxel as an IV infusion
15813757|NCT04336098|Drug|Pembrolizumab|Pembrolizumab as an IV infusion .
15813758|NCT04336085|Procedure|caudal block|Caudal block will be performed using ultrasound guidance, the sacral hiatus will be visualized at the level of the sacral cornus by employing the linear transducer of ultrasound machine the ultrasound transducer will be rotated to 90 degree to obtain longitudinal views of the sacrococcygeal ligament and sacral hiatus and will be subsequently placed between the two cornua. The needle advancement will be terminated immediately after penetrating the sacrococcygeal ligament.
15813759|NCT04336085|Procedure|pericapsular nerve group block|In PENG group, the patient will be placed in supine position. The ilio-pubic eminence (IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be visualized using a linear ultrasound probe. A 22-gauge, 50-mm needle will be introduced in a lateral to medial fashion in an in-plane approach to place the tip of the needle in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, a total volume of 0.5 mL/kg local anesthetic solution will be injected.
15813760|NCT04336072|Behavioral|RFPP|
15813761|NCT04336072|Behavioral|TFCBT|
15813787|NCT04335838|Other|retrospective analysis|The investigators retrospectively analyzed the outcome and possible prognostic factors in polytrauma patients.
15813788|NCT04335825|Procedure|phacotrabeculectomy|combined antiglaucoma procedure: trabeculectomy with phacoemulsification
15813762|NCT04336059|Procedure|pericapsular nerve group block|"The regional block will be performed with the patient in the supine position under complete sterile technique. A low frequency curvilinear ultrasound probe will be initially placed in a transverse plane over the anterior inferior iliacspine (AIIS) and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the iliopubic eminance(IPE), the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will observed.
~A 22-gauge, 80-mm needle will be inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly after local infiltration of the site of the block with 3 ml lidocaine 2%. Following negative aspiration,the normal saline solution will injected in 5-mL increments while observing for adequate fluid spread in this plane."
15813763|NCT04336046|Procedure|erector spinae block|will receive real bilateral ultrasounded guided erector spinae block by bupivacaine at 1 mg /kg in a total volume of 20 ml for each side after induction of anaesthesia in prone position
15813764|NCT04336046|Procedure|sham bilateral ultrasounded guided erector spinae block|will receive sham bilateral ultrasounded guided erector spinae block using 1 mg /kg normal saline in a total volume of 20 ml for each side after induction of anaesthesia in prone position after induction of anaesthesia in prone position.
15813765|NCT04336046|Drug|normal saline|using 1 mg /kg normal saline
15813766|NCT04336046|Drug|Bupivacaine|bupivacaine
15813767|NCT04336033|Other|Counseling|Subjects in the both arms will receive individualized dietetic counseling as the standard dietetic care in Malaysia
15813768|NCT04336033|Other|Renal Diet App|Individualized dietetic counseling aided with a newly developed renal diet app for educative purpose and aiding tool to enhance the dietary adherence among CKD patients. Training on the use of the app will be provided to the subjects prior to the commencement of the intervention. Subjects will be trained on the use of the home screen, icons, feedback screens, the process of entering dietary and fluid intake data and selecting portion sizes. Subjects are considered as competent users when they could correctly record the foods and drinks with correct portion size eaten in the past 24 hours and successfully save the data.
15813769|NCT04336033|Other|Printed Nutrition Pamphlet|"After the counseling session, a standardized renal nutrition pamphlet prepared by dietitians from Universiti Putra Malaysia and Hospital Serdang will be given for patient's educative purpose.
~Since the mobile application is intended for patient's education and self-monitoring (food diary) purposes, and thus, to ensure the comparability between intervention and control groups, the patients in control group will be trained to record their diet intakes manually using the recommended approach 3-day diet records. Nutritional feedback or advices on the diet records will be given to the participants during follow up sessions."
15813770|NCT04336007|Device|Resistive Diathermy (INDIBA® Activ Ct9)|Intervention is conducted using a 65-mm diameter Resistive (RES) electrode (movable), and a planar electrode was used as a return electrode on the abdomen. The electricity is administered in the following manner: cream was applied to the upper limbs existent area, and the electrical output is marked at 75% by moving the movable electrode and if not tolerated by the patient lowered until 35%, Therapy is conducted for 20 minutes, prior swimming time trials.
15813771|NCT04336007|Device|Resistive Diathermy OFF (INDIBA® Activ Ct9)|Placebo is conducted using a 65-mm diameter RES electrode (movable), and a planar electrode was used as a return electrode on the abdomen. The electricity IS NOT administered, the cream was applied to the upper limbs existent area and moving the movable electrode, intervention is conducted for 20 minutes, prior to swimming time trials.
15813772|NCT04336007|Other|Control|This group will warm-up as they usually do in competitions, for later time trial measuring.
15813773|NCT04335994|Device|In-laboratory polysomnography|Level 1 in-laboratory polysomnography for the detection of obstructive sleep apnea.
15813774|NCT04335994|Device|Home Sleep Apnea Test|Use of a home sleep apnea test that records respiratory effort, pulse, oxygen saturation and nasal flow, and reports apneas, hypopneas, flow limitation, snoring and blood oxygen saturation in order to detect obstructive sleep apnea.
15813775|NCT04335981|Device|FT-CC and Swallow Exercises|Once daily treatment with FT Plus with investigational connectivity software and standard of care swallow exercises.
15813776|NCT04335981|Other|Swallow Exercises|Standard of care swallow exercises.
15813777|NCT04335968|Drug|Melatonin 4 mg|melatonin 4mg per os every night, starting the evening before surgery (or 2 hours before emergency surgery) and until day 5 after surgery.
15813778|NCT04335968|Drug|Placebo oral tablet|placebo of this drug with the same schedule, during the same period of time.
15813779|NCT04335942|Other|"Alert AFNOR 3.6."|This alert corresponds to the quantification of the percentage of weight on the slick distributed over a small area (55% on one to three zones totalling 30cm2),
15813780|NCT04335942|Other|"Alertes  AFNOR 3.6  et alertes  Guidelines ."|By alertes Guidelines we mean the clinical recommendations of the Spinal Cord medicine association, i.e. weight relief every 15 to 30 minutes over a period of 1 minute 51 for spinal cord injuries. For patients who do not push up, a tilt of at least 25° of seat and 120° of backrest or a minimum of 45° in one block.
15813781|NCT04335929|Behavioral|Internet-based Cognitive Behavior Therapy|The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
15813782|NCT04335890|Biological|Vaccination with IKKb matured Dendritic Cells|IKKb matured autologous monocyte derived dendritic cells loaded with RNAs; intravenous Infusion with a dose escalation starting with 7.5 mio Dendritic Cells for the first vaccination up to 30 mio cells per vaccination
15813783|NCT04335877|Other|Private sector component + modified BCC|Intervention group will be exposed to the private sector component + modified BCC and will receive current standard care
15813784|NCT04335864|Procedure|Laparoscopic salpingectomy|39 patients with hydrosalpinx will have laparoscopic salpingectomy
15813785|NCT04335864|Procedure|Hystroscopic proximal tubal occlusion|39 patients with hydrosalpinx will have hysteroscopic proximal tubal occlusion
15813786|NCT04335851|Other|Video based aerobic exercise|"During social isolation induced by COVID-19, physically inactive people will do exercise in company with aerobic exercises named videoswalk at home which made by American Heart Association. 3 days a week in total 4 weeks. Each sessions will last approximately 30-40 minutes."
15813821|NCT04335578|Drug|Placebo|Participants will receive matching placebo at pre-specified time-points.
15813789|NCT04335825|Procedure|ExPress antiglaucoma surgery combined with phacoemulsification|combined antiglaucoma procedure: ExPress device implantation with phacoemulsification
15813790|NCT04335812|Behavioral|Internet-based Cognitive Behavior Therapy|The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
15813793|NCT04335786|Drug|Valsartan (Diovan)|"At the time of randomization each participant will start with study treatment and continue up to 14 days, or up to reaching the primary endpoint, or up to hospital discharge, or up to any of the pre-defined stopping criteria.
~Study drug dosages will be titrated to blood pressure with a maximum of 160mg b.i.d."
15813794|NCT04335786|Drug|Placebo oral tablet|At the time of randomization each participant will start with study treatment and continue up to 14 days, or up to reaching the primary endpoint, or up to hospital discharge, or up to any of the pre-defined stopping criteria.
15813795|NCT04335760|Combination Product|Modified Bruce protocol on treadmill|"Fear of activity scale in CAD (FactCAD) was used to assess fear of activity and exercise in subjects with CAD. FactCAD is a novel scale developed specifically for patients with heart disease. Mean time to complete this self-administered scale is 4-7 minutes. The final score of the questionnaire ranges between 0 and 84. High scores indicate higher levels of fear regarding activity or exercise.
~Functional capacity was assessed by 6MWT and exercise test. The 6MWT was performed to all participants according to the American Thoracic Society guidelines in a 30-m corridor10. The subjects were asked to walk as long distance as they could within 6 minutes. The 6MWT distance was recorded in meters.
~Exercise test was performed using modified Bruce protocol on treadmill in institutions where technical equipment and experience was available."
15813796|NCT04335747|Other|COVID-19 infection|Hospitalisation due to a confirmed COVID-19 infection
15813797|NCT04335734|Procedure|Nissen Fundoplication with wrap fixation|Firstly, we performed left crural dissection, division of the short gastric vessels, right crural dissection, and esophageal mobilization. Then repair of HH were made by simple cruroraphy if the size of the defect was less then 10 сm² otherwise mesh for reinforcement of cruroraphy was used. Creation of the wrap was made by passing posterior fundus behind the esophagus from left to right, followed by stitching the edges of the stomach with three interrupted sutures. Wrap was fixated to both diaphragmatic crura or to the body of stomach using two non-absorbable stitches on each side.
15813798|NCT04335734|Procedure|Nissen Fundoplication without wrap fixation|Firstly, we performed left crural dissection, division of the short gastric vessels, right crural dissection, and esophageal mobilization. Then repair of HH were made by simple cruroraphy if the size of the defect was less then 10 сm² otherwise mesh for reinforcement of cruroraphy was used. Creation of the wrap was made by passing posterior fundus behind the esophagus from left to right, followed by stitching the edges of the stomach with three interrupted sutures.
15813799|NCT04335721|Drug|Voxelotor|Voxelotor 1500mg once a day
15813800|NCT04335708|Dietary Supplement|Postibiotic formulation|5 mL daily of edible gel with intracellular content of Lactobacillus casei CRL-431
15813801|NCT04335708|Dietary Supplement|Placebo formulation|5 mL daily of edible gel without intracellular content of Lactobacillus casei CRL-431
15813802|NCT04335695|Behavioral|Vascular Rehabilitation|Vascular rehabilitation is a supervised exercise therapy program that includes healthy lifestyle changes to help patients gain strength, energy and confidence to return to daily activities. A program of supervised exercise rehabilitation is considered a primary treatment for people with Peripheral Artery Disease and Intermittent Claudication. In addition, patients will be given a wrist-worn activity tracker and be in contact with a research coordinator every 3 months after they are discharged from the Vascular Rehab program.
15813803|NCT04335682|Drug|Darolutamide|Patients randomized to darolutamide.
15813804|NCT04335682|Drug|Enzalutamide|Patients randomized to enzalutamide.
15813805|NCT04335669|Drug|epirubicin, cyclophosphamide, paclitaxel, carboplatin|Cytotoxic agents.
15813806|NCT04335669|Drug|epirubicin, cyclophosphamide, capecitabine, paclitaxel, carboplatin|Cytotoxic agents.
15813807|NCT04335656|Dietary Supplement|Lactiplantibacillus plantarum|Probiotic capsule in powder form, which can be swallowed or opened and contents sprinkled on cold foods or beverages
15813808|NCT04335656|Other|Placebo|Placebo capsule in powder form, which can be swallowed or opened and contents sprinkled on cold foods or beverages
15813809|NCT04335643|Behavioral|TEACH|TEACH is a remotely delivered psychological intervention. It consists of six one-hour weekly sessions that are HIPAA compliant and conducted over video conferencing.
15813810|NCT04335630|Diagnostic Test|Electrocardiogram, telemetry, echocardiogram, laboratory values|Serial electrocardiograms, telemetry monitoring, echocardiographic assessment and serial laboratory testing will be used to identify differences among the two study groups.
15813811|NCT04335617|Drug|MMPF (Micronized purified Flavonoid-Fraction)|500mg film-coated tablet, oral route, tablets should be taken at meal times. 4-day course of 6 tablets daily, followed by 4 tablets over the next 3 days followed by 2 tablets daily, one at midday and one in the evening
15813812|NCT04335617|Other|Placebo|4-day course of 6 tablets daily, followed by 4 tablets over the next 3 days followed by 2 tablets daily
15813813|NCT04335604|Drug|JPI-547|The dose levels will be escalated following a 3+3 dose escalation scheme.
15813814|NCT04335591|Drug|75 mg linzagolix tablet|For oral administration once daily
15813815|NCT04335591|Drug|200 mg linzagolix tablet|For oral administration once daily
15813816|NCT04335591|Drug|Placebo tablet to match 75 mg linzagolix tablet|For oral administration once daily
15813817|NCT04335591|Drug|Placebo tablet to match 200 mg linzagolix tablet|For oral administration once daily
15813818|NCT04335591|Drug|Add-back capsule (E2 1 mg / NETA 0.5 mg)|For oral administration once daily
15813819|NCT04335591|Drug|Placebo capsule to match Add-back capsule|For oral administration once daily
15813820|NCT04335578|Drug|Zampilimab|Participants will receive zampilimab (UCB7858) at pre-specified time-points.
15813822|NCT04335565|Other|sugar replacements|Participants will receive a solution of stevia before being administered a fixed meal (lunch). Glucose and insulin levels, and Visual analogue scale data will be collected.
15813823|NCT04335552|Other|Standard of care|Standard of care
15813824|NCT04335552|Drug|Hydroxychloroquine|Hydroxychloroquine will be administered orally or via feeding tube at a dosage of 800 mg on day 1, followed by 600 mg daily on days 2-5
15813825|NCT04335552|Drug|Azithromycin|Azithromycin will be administered orally or via feeding tube at a dosage of 500 mg on day 1, followed by 250 mg daily on days 2-5
15813826|NCT04335539|Drug|Cefiderocol|Administered intravenously over 3 hours
15813827|NCT04335539|Drug|Standard of Care|Standard of care antibiotics will be selected by the investigator based on the suspected or confirmed pathogen(s) for the infection in accordance with local standards.
15813828|NCT04335526|Drug|Cholestyramine Resin|Change bile acid pool by cholestyramine treatment
15813829|NCT04335513|Other|Early CGM-guided education and initiation of insulin therapy.|Careful monitoring of children progressing from stage 2 to stage 3 T1D using continuous glucose monitor (CGM) technology, staged education targeted to assist families in recognizing evolving dysglycemia, and addressing glycemic abnormalities with early initiation of insulin can substantially reduce the HbA1c and risk of DKA at diagnosis, thereby changing the trajectory of the disease course.
15813830|NCT04335513|Other|Usual care: glucometer surveillance and basic education.|"Usual education and advice on glycemic surveillance based on protocols of TEDDY/DAISY/ASK.
~Blinded CGM for 10 days every 3 months to collect data on glycemic profile with basic feedback regarding changes."
15813831|NCT04335487|Behavioral|PSP PTSD Course|A tailored ICBT intervention designed to treat symptoms of PTSD will be delivered to public safety personnel. Clients will be offered once a week support, but support can be increased to twice a week support if PSP request extra support. The intervention is designed to be completed in 8 weeks, but clients will be able to extend their treatment by an additional 8 weeks (i.e., up to 16 weeks in total).
15813832|NCT04335487|Behavioral|PSP Wellbeing Course|A tailored ICBT intervention designed to treat symptoms of depression, anxiety, or PTSD will be delivered to public safety personnel. Clients will be offered once a week support, but support can be increased to twice a week support if PSP request extra support. The intervention is designed to be completed in 8 weeks, but clients will be able to extend their treatment by an additional 8 weeks (i.e., up to 16 weeks in total).
15813833|NCT04335474|Procedure|Surgical drainage strategy|A laparotomy is performed and the operative approach to pancreatic trauma can consist of laparotomy with drainage of the peripancreatic area, distal pancreatectomy with or without preservation of the spleen, Rouxen-Y pancreaticojejunostomy, and, more seldom, pancreaticoduodenectomy. The type of operation depends on the grade of the pancreatic lesion. Spleen-preserving surgery will be attempted to avoid the lifelong increased risk of infections after splenectomy. In case of trauma where multiple organs are involved and an acute laparotomy is performed, the damage control surgery must be applied and the pancreatic resection will be done as part of a staged surgery.
15813834|NCT04335474|Procedure|Percutaneous drainage strategy|The nonoperative management consists of close monitoring of the patient's clinical condition; repeated radiological investigations such as CT, ultrasound, and MRCP; monitoring of the amylase and lipase levels, initiation of post-pyloric enteral nutrition and parenteral nutrition. In addition, ERCP with the placement of a stent in the damaged pancreatic duct is used as part of the non-operative approach. Besides, percutaneous catheter drainage (PCD) management including ultrasound or CT-guided drainage of abdominal and peripancreatic fluid collections and pancreatic pseudocysts is applied to the HGPT patient.
15813835|NCT04335461|Procedure|Cephalomedullary nailing of extracapsular hip fracture|All patients will undergo cephalomedullary nailing of their extracapsular hip fractures. Both short and long nails will be used based on fracture morphology.
15813836|NCT04335461|Device|cephalomedullary nail|Implants to be used will be variable, but include Stryker Gamma, Synthes Trochanteric Fixation Nail, Smith and Nephew Intertan.
15813837|NCT04335461|Drug|Regional Anesthetics|Marcaine 0.25% will be administered for the two experimental arms, as described in above protocol.
15813838|NCT04335448|Other|No intervention is planed|No intervention is planed
15813839|NCT04335435|Dietary Supplement|Oat Bran Consumption|Oat bran (120 g), single dose.
15813840|NCT04335422|Device|Robotic group (Upper extremity robot-assisted training plus routine physical and rehabilitation medicine program)|"Upper extremity robot-assisted training will include facilitated shoulder flexion-extension, internal-external rotation, abduction-adduction, elbow flexion-extension, forearm supination-pronation, wrist flexion-extension, ulnar-radial deviation, hand finger flexion-extension movements by means of visual feedback with a 3-dimensional virtual environment in which the patient is asked to perform various tasks such as object reaching, grasping, holding, dropping activities by playing computer games.
~Routine physical and rehabilitation medicine program including physical therapy and exercises, walking and balance training, and occupational therapy to improve daily living activities will be given."
15813841|NCT04335422|Behavioral|Control group (routine physical and rehabilitation medicine program)|Routine physical and rehabilitation medicine program including physical therapy and exercises, walking and balance training, and occupational therapy to improve daily living activities will be given.
15813842|NCT04335409|Diagnostic Test|Questionnaire|The patients are asked to complete a questionnaire (paper version) once a week during the period of radiotherapy and up to 24 weeks following radiotherapy. In this questionnaire, the patients are asked to state and rate their symptoms potentially associated with pneumonitis. Scoring points are assigned to the severity of the symptoms (symptom scores), and the resulting sum score (patient score) will be used for identification of radiation pneumonitis.
15813843|NCT04335409|Other|Mobile Application|In 10 patients, the paper version of the symptom-based scoring system (questionnaire) will be supplemented by a mobile application (app) asking the same questions regarding symptoms potentially associated with pneumonitis.
15813844|NCT04335383|Biological|Isolation of anti-Pseudomonas antibodies from type B lymphocytes|Blood sampling. Isolation of mononuclear cells from human peripheral blood by density gradient centrifugation. Identification of functional anti-Pseudomonas antibodies by ELISA and cellular infection assays.
15813845|NCT04335370|Other|Blood Draw|"Blood samples will be collected from enrolled patients at 5 time points during a single dosing interval:
~Prior to start of infusion
~End of infusion
~One hour after end of infusion
~Three hours after end of infusion
~Eight hours after start of infusion"
15813846|NCT04335357|Drug|TBR-760|TBR-760 is intended for SC administration. The target dose to be studied in this study is 6 mg SC given once weekly.
15813847|NCT04335357|Drug|Placebo|Placebo
15813848|NCT04335344|Other|Observation of suPAR plasma and salivary levels|Evaluation of suPAR plasma level and correlation of plasma suPAR levels with periodontal and cardiovascular disease
15813849|NCT04335331|Other|PreDM CDS|This novel CDS engages primary care providers and clinical staff to deliver the following intervention components: 1) diabetes prevention risk information; 2) an EHR referral to community-based ILI that meet recommended program requirements; and 3) a prompt for providers to deliver prediabetes treatment.
15813850|NCT04335331|Other|Standard Care|Patients receiving care at non-intervention clinic sites will not be exposed to the PreDM CDS.
15813851|NCT04335318|Device|AI-assisted colonoscopy|Colonoscopies performed with assistance of an AI tool that highlights the areas that are susceptible to be a polyp.
15813852|NCT04335305|Drug|Tocilizumab|IV infusion over 60 minutes; 8 mg/kg (up to a maximum of 800 mg per dose); single dose
15813853|NCT04335305|Biological|Pembrolizumab (MK-3475)|IV infusion over 30 minutes, 200 mg; single dose
15813854|NCT04335292|Drug|Osimertinib First-Line|Osimertinib, 80 mg, oral, daily
15813855|NCT04335292|Drug|Platinum + Pemetrexed Chemotherapy Second-Line|Platinum-based chemotherapy (carboplatin or cisplatin) and pemetrexed are prescribed as per institutional standards.
15813856|NCT04335292|Drug|Osimertinib Third-Line|Rechallenge with osimertinib, 80 mg, oral, daily
15813857|NCT04335279|Other|SPIN-CHAT Program|Each session will include 3 segments: (1) engagement via therapeutic recreation activities (20-30 minutes); (2) education on information management and anxiety management through psychological and other strategies (20-30 minutes); and (3) open discussion and social support (20-30 minutes). Educational segment topics will include (1) healthy information management and social connection (session 1); (2) managing worry (sessions 2, 6, 10); (3) relaxation strategies (sessions 3; 7, 11); (4) adapted home exercise (sessions 4, 8, 12); and (5) activity engagement at home (sessions 5 and 9). All educational segments will be supported by resource materials available to participants via an online SPIN-CHAT resource link. Supervision and support of group moderators will be provided by a trained social worker. Educational segments in each session will be delivered by a research team member with experience and training related to the topic.
15813858|NCT04335266|Drug|SHR2554|SHR2554
15813859|NCT04335253|Drug|EOS884448|Multiple Ascending Dose
15813860|NCT04335240|Other|Premature family music therapy intervention to support parenting, attachment bond and preterm development|We have structured an integrated psychological and music therapeutic protocol that aims to limit or overcome neonatal long-term developmental morbidities, promote parenting and attachment bond in preterm infants.
15813861|NCT04335227|Other|Structured yoga therapy program|Structured yoga therapy prepared according to traditional yoga scriptures of Patanjali yoga sutras will be administered to 32 females with PCOS. The structured yoga therapy which includes, Surya Namaskara (Sun Salutation) and asanas performed in four positions, standing, sitting, supine and prone for total duration of 60 minutes. In addition to this, they will be asked to undergo nutritional management uniquely prepared by dietitian
15813862|NCT04335227|Other|Aerobic exercise training program|Thirty two females with PCOS in aerobic exercise (AE) group will be subjected to aerobic training of moderate intensity for 30-60 minutes six days per week for 12 weeks, in the light of guidelines framed by American College of Sports Medicine (ACSM). Aerobic exercise volume for each female recruited will be set at greater than 500 and up to 1000 MET-min/week, which will be approximately equal to 1000 kcal/week. They will be made sure that they exercise for minimum duration of 150 min/week and thereby covering 5400 to 7900 steps/day in pedometer readings. In addition to this, they will be asked to undergo nutritional management uniquely prepared by dietitian
15813863|NCT04335227|Other|Combined yoga and aerobic training program|Thirty two females with PCOS in combined yoga therapy and aerobic exercise (cYTAE) group will be subjected to three days of structured yoga therapy and three days of aerobic training of vigorous intensity. In addition to this, they will be asked to undergo nutritional management uniquely prepared by dietitian
15813864|NCT04335227|Other|Nutritional management|Thirty two females with PCOS will be asked to undergo only nutritional management uniquely prepared by dietitian
15813866|NCT04335201|Drug|Defibrotide Injection|Patients will be treated according to the standard institutional procedures and will receive the best available treatment as per institutional guidelines in association with the experimental drug: Defibrotide 25 mg/kg body weight total dose in 2 hours duration infusion each, every 6 hours (Defibrotide 6.25 mg/kg body weight each dose) Treatment duration = 7 days
15813867|NCT04335188|Other|Prospective oberservational registry|Non interventional study.
15813868|NCT04335175|Other|None - observational study|None - observational study
15813869|NCT04335136|Drug|RhACE2 APN01|Patients will be treated with APN01 intravenously twice daily (BID).
15813870|NCT04335136|Drug|Physiological saline solution|Patients will be treated with placebo intravenously twice daily (BID).
15813871|NCT04335123|Drug|Losartan|25 mg QD from day 0 to day 3. Dose escalation to 50 mg QD until study completion
15813872|NCT04335110|Behavioral|STELLA (Support via TEchnology: Living and Learning with Advancing Alzheimer's disease and related dementias)|STELLA consists of 8 sessions: 4 sessions one-to-one, with the Care Partner and a Guide, and then 4 sessions with one Guide with up to four Care Partners (total small group will include as few as two and as many as 4 Care Partners) Each weekly session takes about 1 hour. The first four sessions allow for development of the Care Partner-Guide working relationship. In these sessions, the Care Partners identify behaviors (both the person with dementia's and the Care Partner's) which are upsetting to the family. Care Partners will be taught to use an Activator, Behavior, Consequence (ABC) approach to identify activators of behaviors, the behaviors, and consequences of the behaviors. After they identify the ABCs, they will develop a plan to address the behavior and then test it. After the four one-to-one sessions, Care Partners will meet in small groups with a Guide. Effective communication strategies, engagement in pleasant events, and coping will be addressed.
15813873|NCT04335097|Device|Biosensors|Sensor that detect vital signs
15813878|NCT04335071|Drug|Tocilizumab (TCZ)|Patients get one dose (= 8 mg/kg bodyweight, max. single dose 800 mg) Actemra® (active ingredient: TCZ) intravenously in 100 mL NaCl 0.9% after confirmation of progressive dyspnoea. Infusion time: 60 min. The procedure is repeated once if no clinical improvement in the 8-point WHO scale is observed.
15813879|NCT04335071|Drug|Placebo|The placebo-controlled intervention is one dose (100 mL) NaCl 0.9% intravenously administered after confirmation of progressive dyspnoea. Infusion time: 60 min. The procedure is repeated once if no clinical improvement in the 8-point WHO scale is observed.
15813880|NCT04335058|Drug|Lactoferrin + Iron Supplement|Lactoferrin 100 mg twice daily +oral iron
15813881|NCT04335058|Drug|Iron Supplement|Oral iron supplement alone
15813882|NCT04335045|Drug|Placebo|1~8 Placebo capsule(s) corresponding to each PH100 dose
15813883|NCT04335045|Drug|PH100 100mg|1 x 100 mg PH100 oral capsule
15813884|NCT04335045|Drug|PH100 200mg|1 x 200 mg PH100 oral capsule
15813885|NCT04335045|Drug|PH100 400mg|2 x 200 mg PH100 oral capsules
15813886|NCT04335045|Drug|PH100 800mg|4 x 200 mg PH100 oral capsules
15813887|NCT04335045|Drug|PH100 1200mg|6 x 200 mg PH100 oral capsules
15813888|NCT04335045|Drug|PH100 1600mg|8 x 200 mg PH100 oral capsules
15813889|NCT04335032|Drug|Eicosapentaenoic acid gastro-resistant capsules|same as in arm/group description
15813890|NCT04335032|Drug|Placebo|same as in arm/group description
15813891|NCT04335019|Other|Pulmonary ultrasound|Pulmonary ultrasound results: quotation in 8 fields (right antero-superior, left antero-superior, right antero-inferior, left antero-inferior, right postero-superior, left postero-superior, right postero-inferior and postero-upper left).
15813892|NCT04335006|Drug|Carelizumab|Participants receive SHR-1210 intravenously (IV)
15813893|NCT04335006|Drug|Nab-paclitaxel|administered intravenously every 4-week cycle
15813894|NCT04335006|Drug|Apatinib|administered orally every 4-week cycle
15813895|NCT04334993|Drug|Blinatumomab|Patients with high risk disease features after 2 induction blocks as defined per protocol will be treated with CNS directed block followed by up to 2 cycles of blinatumomab (for B-cell ALL) followed by allogeneic stem cell transplantation.
15813896|NCT04334980|Biological|bacTRL-Spike|Each oral dose of bacTRL-Spike contains bacterial medium with either 1 billion (Group 1), 3 billion (Group 2) or 10 billion (Group 3) colony-forming-units of live Bifidobacterium longum, which has been engineered to deliver plasmids containing synthetic DNA encoding spike protein from SARS-CoV-2.
15813897|NCT04334967|Drug|Hydroxychloroquine|Treatment arm medication will be administered on an outpatient basis. Due to the emergent health crisis, study drug will be delivered to patients by institution staff or contract courier using a non-contact protocol.
15813898|NCT04334967|Dietary Supplement|Vitamin C|Control arm supplement will be administered on an outpatient basis. Due to the emergent health crisis, study supplies will be delivered to patients by institution staff or contract courier using a non-contact protocol.
15813901|NCT04334928|Drug|Emtricitabine/tenofovir disoproxil|Emtricitabine/tenofovir disoproxil, 200 mg/245 mg tablets. A dose of one tablet once a day will be administered.
15813902|NCT04334928|Drug|Hydroxychloroquine|Hydroxychloroquine, 200 mg tablets. A dose of one tablet once a day will be administered.
15813903|NCT04334928|Drug|Placebo: Emtricitabine/tenofovir disoproxil Placebo|Placebo: Tablets similar in appearance to Emtricitabine/tenofovir disoproxil
15813904|NCT04334928|Drug|Placebo: Hydroxychloroquine|Placebo: Tablets similar in appearance to Hydroxychloroquine
15813905|NCT04334915|Drug|Cenicriviroc Mesylate (CVC)|Administered orally
15813906|NCT04334915|Drug|Placebo|Administered orally
15813907|NCT04334902|Device|mPDia|Clinical decision support system for diagnosing neurodegenerative parkinsonism
15813908|NCT04334889|Other|Visual cues|Participants will be asked to move following cues displayed on a screen in front of them.
15813909|NCT04334876|Diagnostic Test|SARS-CoV-2 IgG Antibody Testing Kit|A, finger prick, at home test for SARS-CoV-2 IgG Antibodies.
15813910|NCT04334863|Drug|WP1066|"WP1066 is an analogue of caffeic acid that is a potent inhibitor of p-STAT3.
~It will be taken by mouth 2 times per day on Monday, Wednesday, and Friday of Weeks 1 and 2 of each 28-day cycle."
15813911|NCT04334850|Procedure|Combined use of a respiratory broad panel multiplex PCR and procalcitonin|The actions or procedures added by the research are the application of the algorithm of early antibiotics de-escalation and discontinuation.
15813912|NCT04334850|Other|Usual antibiotic treatment|The antimicrobial therapy is left at the discretion of the physicians, as in usual practice.
15813913|NCT04334837|Diagnostic Test|Copper Cu 64 Dotatate|The drug product contains Copper Cu 64 Dotatate filled in a glass vial, closed with butyl rubber stopper secured with an aluminum crimp seal. The drug product will be delivered by Curium to the clinical site. The EAP drug will be administered as an intravenous bolus injection. The dose will be administered according to the schedule detailed in the protocol.
15813914|NCT04334824|Drug|Hydrochlorothiazide|Exposure to hydrochlorothiazide will be defined as a prescription for hydrochlorothiazide alone or in combination with non-ACE inhibitor antihypertensive drugs at cohort entry date.
15813915|NCT04334824|Drug|Angiotensin-converting enzyme (ACE) inhibitors|Exposure to ACE inhibitors will be defined as a prescription for an ACE inhibitor alone or in combination with non-hydrochlorothiazide antihypertensive drugs at cohort entry date.
15813916|NCT04334811|Radiation|Stereotactic ablative radiotherapy|Stereotactic ablative radiotherapy (SAbR) delivers of a potent, ablative or nearly ablative dose of radiation in oligofractions (ie, five or fewer fractions) primarily to create a compact dose delivered accurately to the intended target with steep gradients in all directions (geometric avoidance) and avoid damaging normal tissues.
15813917|NCT04334798|Other|Active exercises of the pelvic floor muscles & Electrostimulation & Biofeedback|See information included in arm/group descriptions.
15813918|NCT04334798|Other|Active exercises of the pelvic floor muscles & Biofeedback|See information included in arm/group descriptions.
15813919|NCT04334798|Other|Active exercises of the pelvic floor muscles & Transabdominal US Biofeedback|See information included in arm/group descriptions.
15813920|NCT04334798|Other|Active exercises of the pelvic floor muscles & Electrostimulation &Transabdominal US Biofeedback|See information included in arm/group descriptions.
15813921|NCT04334785|Device|cryo-ablation|Under the guide of ultrasound, cryo-ablation for the lump of early invasive breast cancer will be conducted.
15813922|NCT04334772|Device|Muscle belly Microelectrolysis|three applications of direct current at 600 µA interrupted by intervals of 30 seconds between application at the level of the muscular belly of the shortened hamstrings.
15813923|NCT04334772|Device|Tendon Microelectrolysis|three applications of direct current at 600 µA interrupted by intervals of 30 seconds between application in the tendon of the shortened hamstrings.
15813924|NCT04334772|Other|Stretching exercises|5 sets of passive static hamstring stretches using the straight leg extension (SLR) test for a time of 30 seconds and interval of 30 seconds for each
15813927|NCT04334746|Other|Balance measurement tools|Timed Up and Go Test Functional Reach Test One-leg Stance Test Berg Balance Scale
15813928|NCT04334733|Other|Cartoon group|The children in the groups were distracted by watching cartoon 5 minutes before echocardiography process.
15813929|NCT04334733|Other|Kaleidoscope group|The children in the groups were distracted by kaleidoscope during echocardiography, until the process was over.
15813930|NCT04334733|Other|Cartoon+Kaleidoscope group|The children in the groups were distracted by watching cartoon 5 minutes before echocardiography process and then the children in the groups were distracted by kaleidoscope during echocardiography, until the process was over.
15813931|NCT04334720|Other|Comprehensive treatment of tumor|According to the pathologic types and TNM stage of tumor，specialists chose one or more of the interventions in surgery, radiotherapy, chemotherapy, targeted therapy and immunotherapy.
15813932|NCT04334707|Procedure|Kidney Biopsy|A kidney biopsy is a procedure that involves taking a small piece of kidney tissue for examination with a microscope. A licensed health care provider will perform a kidney biopsy.
15813933|NCT04334694|Device|Atrial flow regulator (Occlutech® AFR device)|Atrial septostomy followed by implantation of AFR.
15813934|NCT04334681|Procedure|Un-roofing curettage method|In this method, the roof of the pilonidal cyst is opened, and the inside is cleaned, and curettage is performed. The wound is closed with a dressing after hemostasis.
15813935|NCT04334681|Procedure|Modified Limberg Flap Group|In this method, the pilonidal cyst is excised with a rhomboid incision and closed with the modified Limberg flap method.
15813936|NCT04334668|Dietary Supplement|Oral Sodium Chloride|Subjects will be randomized to receive 2 grams oral Sodium Chloride three times daily with meals for approximately 4 days
15813937|NCT04334668|Other|Placebo|Subjects will be randomized to receive a placebo three times daily with meals for approximately 4 days.
15813938|NCT04334655|Other|Physical Therapy|Patients with primary complaints of neck pain will receive routine physical therapy care including modalities, manual therapy including neck mobilization and manipulation, stretching and strengthening exercises, and patient education.
15813939|NCT04334642|Other|A mindfulness based intervention|It is a pilot study of feasibility and preliminary effectiveness composed of a longitudinal intervention that uses as a baseline measure a Mindfulness Training of 2 cycles (each cycle is formed by 4 days of intervention); two follow-up measures (1 and 6 months after the 2nd cycle); and a final measurement (12 months after the start of the study).
15813940|NCT04334629|Drug|Ibuprofen|Lipid ibuprofen 200 mg
15813941|NCT04334616|Device|Video Laryngocope|VDL used for VDL arm
15813942|NCT04334616|Device|Macintosh Conventional Laryngocope|Used for Conventional laryngocope arm
15813943|NCT04334603|Other|Exercise Training Program|The 12-week exercise-training program will include two sessions of combined exercise training per week, performed at the hospital or at home.
15813944|NCT04334590|Procedure|Cleft Lip/Nose Repair without PSIO|Standard of care surgical repair of cleft lip/nose without PSIO.
15813945|NCT04334590|Procedure|Presurgical Infant Orthopedic Therapy|Standard of care surgical repair of cleft lip/nose with PSIO.
15813946|NCT04334577|Biological|live attenuated zoster vaccine|subcutaneous injection
15813947|NCT04334577|Biological|placebo|subcutaneous injection
15813948|NCT04334564|Drug|Ginkgo biloba capsule|Ginkgo biloba capsule may improve visual function of primary open-angle glaucoma by repairing of the optic nerve.
15813949|NCT04334564|Drug|Placebos|Placebos were controls.
15813950|NCT04334551|Drug|Doravirine|switches from etravirine to doravirine, in experienced HIV patients
15813951|NCT04334538|Dietary Supplement|S-RUTF|Children will receive approximately 150 kcal/kg/d of standard ready-to-use therapeutic food which provides a full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child.
15813952|NCT04334538|Dietary Supplement|oat RUTF|Children will receive approximately 150 kcal/kg/d of oat ready-to-use therapeutic food which provides a full daily doses of vitamins and micronutrients. Caregivers will instruct caregivers to feed the supplement only to the enrolled child.
15813953|NCT04334525|Behavioral|Choice architecture + repeated exposure|Participants will receive placemats promoting healthier featured kids' meals and the opportunity to redeem their kids' meal token for a toy instead of dessert. Families will also receive a frequent diner card, which after purchasing one of the featured healthier kids' meals across 6 occasions, makes them eligible for a free kids' meal of their choice during a predetermined redemption period.
15813954|NCT04334512|Drug|Hydroxychloroquine|Treatment with hydroxychloroquine
15813955|NCT04334512|Drug|Azithromycin|Treatment with azithromycin
15813956|NCT04334512|Dietary Supplement|Vitamin C|Treatment with vitamin C
15813957|NCT04334512|Dietary Supplement|Vitamin D|Treatment with vitamin D
15813958|NCT04334512|Dietary Supplement|Zinc|Treatment with Zinc
15813959|NCT04334499|Other|Sample collection from tissue discard|Collection of vitreous humor tissue and venous blood from subjects undergoing ocular surgery that may provide vitreous humor discarded tissue.
15813960|NCT04334486|Other|Super Smash Brothers Melee (Gamecube)|10 minutes of participation in Super Smash Brothers Melee prior to Eyesi Surgical Simulator evaluation of skills.
15813961|NCT04334473|Procedure|phacoemulsification and Intraocular lens implantation|Standartd surgical procedure with small incision to remove catarct using ultrasound waves. it can be done by topica, local or general anaesthesia acoording to patients general fitness and preference.
15813962|NCT04334473|Diagnostic Test|Ultrasound Biomicrosopy (UBM)|A diagnostic test using ultrasound waves to evaluate the anterior chamber depth, angle and lens vault.
15813963|NCT04334460|Drug|BLD-2660|BLD-2660 is a novel, synthetic, orally active, small molecule inhibitor of calpain (CAPN) 1, 2, and 9.
15813964|NCT04334447|Other|Improved primary care HF diagnostics|Reimbursement of natriuretic peptide testing for participating general practitioners (GPs) Audit and feedback in GPs EHR
15813965|NCT04334447|Other|Heart Failure education|Reimbursement of heart failure education for patients at risk. Web-based training for participating general practitioners
15813966|NCT04334447|Other|Structured transitional protocol planning post-discharge care|Checklist-supported discharge protocol for HF patients including telephone contact with patients' general practitioners and a contact with the HF educator
15813967|NCT04334434|Other|Telerehabilitation|15 volunteers over 65 years old who are at home during the social isolation process due to the coronavirus outbreak will be included in this group. An online exercise protocol was created for individuals who will participate in the study. Each exercise session was planned as 30 minutes for 3 days a week for 4 weeks. It was planned to start the protocol with warm-up exercises and finish with cooling exercises. The exercise protocol was additionally determined as a combination of aerobic and strengthening exercises. Individuals were asked to participate in the study via Skype and aimed to do their exercises with a physiotherapist
15813968|NCT04334421|Device|Composite mesh|Pelvic floor is reconstructed by synthetic composite mesh (Symbotex, Medtronic) to improve healing and prevent perineal herniation.
15813969|NCT04334408|Drug|Fremanezumab|Subjects will receive a single dose total 225 mg (1 injection of 225 mg per 1.5 mL injection) followed by a single dose of 225 mg (1 1.5mL injection) at four week intervals. Both the subject and the investigator will be blinded to the timing of transition to and from placebo and the transition to and from fremanezumab.
15813970|NCT04334408|Drug|Placebo|Placebo injections during the run in and washout serves as the control condition. Both the subject and the investigator will be blinded to the timing of transition to and from placebo and the transition to and from fremanezumab.
15813971|NCT04334395|Procedure|primary tumor resection group|resection of cancer at colon
15813972|NCT04334382|Drug|Hydroxychloroquine|Patients in the hydroxychloroquine arm will receive hydroxychloroquine 400mg po BID x 1 day, then 200mg po BID x 4 days (dose reductions for weight < 45kg). The drug dose (2.4 gm over 5 days) chosen falls at the lower end of doses proposed in various international trials, but it has proven in vitro efficacy, with a ratio of lung tissue trough concentrations to the EC50 (effective concentration to suppress 50% of viral activity) of >20.
15813973|NCT04334382|Drug|Azithromycin|Patients in the azithromycin arm will receive azithromycin 500mg PO on day 1 plus 250mg PO daily on days 2-5.
15813974|NCT04334369|Device|Proclear Single Vision Contact Lenses manufactured by CooperVision|FDA approved single vision contact lenses.
15813975|NCT04334369|Device|Proclear Multifocal Contact Lenses manufactured by CooperVision|FDA Approved Multifocal Contact Lenses
15813976|NCT04334356|Behavioral|Mobile Web App|App for preventing development of posttraumatic stress based on cognitive behavioral techniques.
15813977|NCT04334343|Other|Additional Muscle Biopsy Collection|Subjects will be asked if an additional biopsy from an existing incision can be obtained (i.e. additional needle insertion). For each biopsy required in the main MoTrPAC study (NCT03960827), a small needle will be used to inject some numbing medication (similar to what a dentist uses) in your thigh. A small incision (about 1/4 inch) will be made and a special needle will be used to collect 1 or 2 muscle samples (about the size of a pea).
15813978|NCT04334330|Drug|Palbociclib, Trastuzumab, Lapatinib and Fulvestrant|ER positive, HER2-positive breast cancer patients with brain metastatic lesions receive palbociclib PO daily on days 1-21, combined with trastuzumab IV every three weeks, lapatinib PO daily and fulvestrant IM every 4 weeks. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
15813979|NCT04334317|Drug|TAK-071|TAK-071 tablet.
15813980|NCT04334317|Drug|Placebo|TAK-071 placebo-matching tablet.
15813981|NCT04334304|Procedure|Total Knee Prosthesis - type Bicruciate retaining|A total knee arthroplasty will be performed with a bicruciate retaining implant (Journey II, XR). The control group will consist out of patients receiving a posterior stabilized implant (Journey II, BCS).
15813982|NCT04334304|Procedure|Robot-assisted Total Knee Arthroplasty|A total knee arthroplasty will be performed with robot-assistance (NAVIO).
15813983|NCT04334304|Procedure|Total Knee Prosthesis - type Posterior Stabilized|A total knee arthroplasty will be performed with a bicruciate retaining implant (Journey II, XR). The control group will consist out of patients receiving a posterior stabilized implant (Journey II, BCS).
15813984|NCT04334291|Combination Product|Observational (registry)|Observational study.
15813985|NCT04334278|Behavioral|GetHealthy-OA|The GetHealthy-OA is an 6-week group mind body program with efficacy in improving depression, physical function and aiding in weight loss, that has been adapted for the unique needs of patients with knee osteoarthritis, depression and obesity. The GetHealthy-OA will be delivered by secure telehealth.
15813986|NCT04334278|Behavioral|Health Enhancement Program|The Health Enhancement Program is a chronic pain-specific program adapted for the specific needs of patients with knee osteoarthritis. It is an 6-week group mind body program that will be delivered via secure telehealth.
15813987|NCT04334265|Drug|Anluohuaxian|6g each time, twice a day
15813988|NCT04334252|Other|Questionnaire|Questionnaire
15813989|NCT04334239|Other|Oncological certification|Oncological certification encompasses a variety of criteria such as treatment according to the clinical guidelines, staffing, technical infrastructure, minimum caseloads, and multidisciplinary care.
15813990|NCT04334226|Other|Interview|Interviews will explore the patient's and caregiver's experiences and perceptions of ostomy surgery prior to the Bootcamp and after the Bootcamp from a physical, psychological, social, and spiritual perspective
15813991|NCT04334213|Drug|CKD-501|QD, PO
15813992|NCT04334213|Drug|D745, D150|QD, PO
15813993|NCT04334213|Drug|CKD-501, D745, D150|QD, PO
15814016|NCT04333992|Drug|sevoflurane and remifentanil|inhalator sevoflurane and remifentanil using target-controlled infusion (TCI) devices
15813994|NCT04334200|Behavioral|Cultivate yourself: support for caregivers of dementia persons|The Chinese cultural values, including philosophical thoughts, will be included in the intervention. Chinese philosophical thoughts including the concepts of moderation, improving oneself, and harmony with nature will be used in the intervention. Confucianism, Taoism and Buddhism are the foundation for Chinese for concepts of health and illness, health promotion, and health-seeking behavior. Therefore, it is necessary to incorporate such philosophies in the sessions of the program.
15813995|NCT04334187|Behavioral|Mindfulness Based addition treatment|The intervention is comprised of 8 weekly group MBAT sessions. Two weekly groups of about 10 participants each will be conducted. All participants will also have the option to receive nicotine patches, gum, or lozenges for four weeks as part of their time in the study. Participants will complete surveys at enrollment (baseline), immediately after their last MBAT session (around 2 months after enrollment) and one month after completing treatment (3 months post-enrollment). Surveys will assess primary and secondary outcomes and satisfaction with the intervention.
15813996|NCT04334174|Drug|Brentuximab Vedotin|Brentuximab Vedotin will be dosed at 1.8 milligram (mg) per (/) kilogram (Kg) of participants body weight will be infused intravenously every three weeks for up to ten infusions.
15813997|NCT04334161|Combination Product|Administration of glucose and controlled induction of hypoglycaemia.|Functional metabolic test involving a 15g oral glucose load (enriched with 1.5% U-13C glucose) and subsequent controlled 20min hypoglycaemic clamp period. Neuroendocrine response will be assessed using frequent blood samples for hormones and metabolites, continuous heart rate monitoring and evaluation for hypoglycaemic symptoms.
15813998|NCT04334148|Drug|Hydroxychloroquine|oral self administered tablet
15813999|NCT04334148|Drug|Placebo oral tablet|oral self administered tablet
15814000|NCT04334135|Dietary Supplement|MitoQ|Four to eight 20mg capsules (depending on body mass)
15814001|NCT04334122|Other|Instrument-assisted soft tisue mobilization|"All patients in the experimental group were given a traditional physiotherapy program applied in lumbar disc herniation for 4 weeks (20 sessions) and 5 days a week.
~In addition to the traditional physiotherapy program, the patients in the experimental group were subjected to tool-assisted soft tissue mobilization 3 times a week (12 sessions with 1 day interval).
~All evaluations were repeated to all patients in the experimental and control groups after four weeks."
15814002|NCT04334122|Other|Traditional physiotherapy|All patients in the control group were given a traditional physiotherapy program applied in lumbar disc herniation for 4 weeks (20 sessions) and 5 days a week.
15814003|NCT04334109|Behavioral|Family Diabetes Self-Management Education and Support|Family Diabetes Self-Management Education and Support demonstrates the effectiveness of family-centered models of DSME that explicitly address diabetes self-management within a family context by educating both patients and family members and focusing on family motivational interviewing, family goal setting, understanding supportive and nonsupportive behaviors, and family behavioral changes.
15814004|NCT04334109|Behavioral|Standard Diabetes Self-Management Education and Support|Diabetes Self-Management Education and Support demonstrates the effectiveness of individual model DSMES that explicitly address diabetes self-management within an individual context by educating individual patients on individual motivational interviewing, individual goal setting, and individual behavioral changes.
15814005|NCT04334096|Behavioral|quality of life pathway|The first quality of life (QoL) measurement is conducted in the hospital after surgery via a digital questionnaire (EORTC QLQ-C30, QLQ-BR23) on a tablet computer. Further QoL measures are accomplished via paper-pencil in the practice of the patient's physician during aftercare (3, 6, 9, 12, 18, 24 months after surgery). Paper questionnaires are transferred by fax to a local server, automatically processed, digitized and stored in a database, and transferred back to the physician's practice (email or fax depending on preference) in form of a QoL profile. The immediate response enables patient and physician to discuss the QoL profile right away. Specific therapeutic options for the treatment of QoL have been defined: psychotherapy, social counseling, pain therapy, physiotherapy, nutrition counseling, fitness. To provide continuous medical education, quality circles for each therapeutic option have been founded. Physicians receive a list with addresses of all quality circle members.
15814006|NCT04334083|Behavioral|Comparison of biomarkers of stress|Emergency will be followed during a night shift and the rest day et during a day shift and the rest day. They will be observed by a student (psychology student or medical externship student). We will assess the role of expertise and habituation to stressful emergency situations between two untrained external observers
15814007|NCT04334070|Drug|Lamprene®/Clofazimine|All participants will receive Lamprene/clofazimine 50 mg capsules. The recommended dose of clofazimine for this program is 100 mg once daily, administered orally, preferably with meals. Duration of treatment will be decided by the treating physician. When considering clofazimine for the treatment of NTM infection, clofazimine is to be administered as part of a multi-drug regimen.
15814009|NCT04334044|Drug|Ruxolitinib Oral Tablet|Ruxolitinib 5 mg twice a day
15814010|NCT04334031|Genetic|Biobanking with genetic analysis|Patients included in the IMMINeNT cohort will be collected 7 blood samples for the research project at each revaluation visit. For patients who accepted, genetic analysis (DNA analysis) will be done on a part of those samples.
15814011|NCT04334031|Other|SF-12 questionnaire|Patients included in the IMMINeNT cohort will be asked to complete SF-12 quality of life questionnaire.
15814012|NCT04334018|Device|conventional CRT|"Conventional CRT or biventricular pacing resynchronizes left ventricular contraction by pacing the right and left ventricles (LV) simultaneously"
15814013|NCT04334018|Device|MPP CRT|CRT with Multipoint pacing (MPP) where pacing can occur from more than one LV site simultaneously
15814014|NCT04334005|Dietary Supplement|Vitamin D|The intervention group will receive a single dose of 25000 UI of vitamin D supplement in addition to prescription of NSAIDs, ACE2 inhibitor, ARB or thiazolidinediones, according to clinician criteria, based on the current recommendations. Vitamin D supplementation will be taken in the morning together with a toast with olive oil to facilitate its absorption.
15814015|NCT04333992|Drug|propofol and remifentanil|intravenous propofol and remifentanil using target-controlled infusion (TCI) devices
15814018|NCT04333966|Behavioral|Interactive Social Networking Site Parent Based Intervention|Parents in the interactive PBI condition will receive an interactive web-based SNS PBI with text message prompts aimed to reduce adolescent alcohol use and risky cognitions related to alcohol displays on SNS.
15814019|NCT04333966|Behavioral|Active Control|Parents in the active control condition will receive an emailed copy of the Surgeon General's Call to Action: A Guide for Families.
15814020|NCT04333953|Other|No intervention|No intervention, observational study
15814021|NCT04333940|Procedure|periapical surgery|clinical signs and symptoms, probing depth, Clinical attachment level (CAL ), dimensions of lesion, distance from the defect and apex of tooth to the anatomical structures will be measured
15814022|NCT04333927|Drug|Chemotherapy|Capecitabine (1,330 mg/m2 per day, in divided doses twice daily, 7 days per week).
15814023|NCT04333927|Other|Observation|Patients in observation group will not receive any anti-cancer therapy.
15814024|NCT04333927|Procedure|Immunotherapy|Camrelizumab 200mg intravenously every 3 weeks until clinical or radiographic disease progression, unacceptable toxicity, death, termination of the study or withdrawal.
15814025|NCT04333927|Radiation|Radiotherapy|45 Gy to regional lymph nodes and 54 to 59.4 Gy to preoperative tumor bed.
15814026|NCT04333914|Drug|Autophagy inhibitor (GNS651)|Cohort 1 (arm B): 200mg q.d. orally for 10 consecutive days. If for any reason a treatment is not given within the allowed treatment window (± 12h) it will be cancelled (i.e., missed for that time point), and treatment will be resumed at the next dosing day.
15814027|NCT04333914|Other|Standard of care|"In cohorts 1 and 2, patients allocated in the standard of care arms should receive best supportive care, as per the investigator's discretion and the local routine practices. With regards to the respiratory symptoms and medical resoures at investigational site, the following should be given according to the patient's condition: oxygen supplementation, non-invasive ventilation, invasive ventilation, antibiotherapy, vasopressor support, renal replacement therapy, or extracorporeal membrane oxygenation.
~Additional care and medications should be administered in the patient's best interest."
15814028|NCT04333914|Drug|Avdoralimab|Cohorte 2 (arm H): 500mg, intravenously, at Day 1 then 200mg once daily every 2 days during 14 Days
15814029|NCT04333914|Drug|Monalizumab|Cohorte 2 (arm G) : 50mg (flat dose),intravenously, single infusion at Day 1.
15814030|NCT04333888|Behavioral|Neurofeedback|fMRI neurofeedback training of amygdala downregulation
15814031|NCT04333875|Device|TAVR or SAVR|Patients with critical aortic stenosis as defined by an AVA <0.6 cm2 or a transvalvular mean gradient of >60 mmHg or a history of cardiac decompensation during the previous 3 months or clinical symptoms on minimal exertion (NYHA III) will be allocated to TAVR or SAVR.
15814032|NCT04333836|Device|Removable Clear Aligners|"Plaster dental models will be poured from the rubber base impression.
~Digital dental models will be created through scanning of plaster dental models.
~Planning of the aligners will be done on 3 shape clear aligner studio®.
~Aligners will be fabricated on 3d printed models using vacuum formers.
~Anchorage reinforcement for posterior segments by using buccal miniscrews.
~Patient will receive the first aligner and will be instructed to wear it full time (except during eating and brushing) for 2 weeks.
~Patient will receive the following aligner after 2 weeks.
~Follow up visits every 2 weeks until complete canine retraction."
15814033|NCT04333823|Drug|Dapagliflozin 5mg|Dapagliflozin tablet
15814034|NCT04333823|Drug|Placebo|Sugar pill manufactured to mimic Dapagliflozin 5mg tablet
15814035|NCT04333810|Device|Whoop strap 3.0|WHOOP strap 3.0, a photodiode-based device that tracks sleep duration, resting heart rate, heart rate variability, activity (calories).
15814036|NCT04333797|Other|Risk and Protective Factors Assessment|First assessment at baseline (T0) - 17 y.o. Follow-up 2 years later (T1) - 19 y.o.
15814037|NCT04333784|Other|Exercise training|Exercise with blood flow restriction (with a pneumatic cuff).
15814038|NCT04333771|Drug|SHR0302|The placebo group will take drugs orally for 24 weeks, and then switch to SHR0302 dose1 for 28 weeks, in the meanwhile, SHR0302 dose1 group and SHR0302 dose2 group will continue taking drugs for the whole 52 weeks.
15814039|NCT04333771|Drug|Placebo|The placebo group will take drugs orally for 24 weeks, and then switch to SHR0302 dose1 for 28 weeks, in the meanwhile, SHR0302 dose1 group and SHR0302 dose2 group will continue taking drugs for the whole 52 weeks.
15814040|NCT04333758|Device|Jintronix Virtual Reality Telerehabilitation System|"System consists of an internet-based rehabilitation software linked to a Microsoft Kinect camera for motion detection.
~Study team therapist prescribed a list of guided exercises and therapeutic activities (games) for training of whole body, lower and upper extremities. These can be done in sitting or standing, depending on individual participant's capacity.
~Telemonitoring is done by study team therapist during each of the training day (Mondays-Fridays) of the home-based training phase. Training performance results are reviewed and training games are adjusted or changed to optimise home training."
15814041|NCT04333745|Other|Controlled Diet|Participant will consume a controlled low oxalate diet for five days
15814042|NCT04333745|Dietary Supplement|Carbon-13 Oxalate and Sucralose Ingestion|Subjects will ingest a small amount of carbon-13 oxalate and sucralose, dissolved in water.
15814043|NCT04333732|Drug|MR or M-M-R II ® vaccine|Education and surveillance plus MR or M-M-R II ® vaccine
15814044|NCT04333732|Drug|Placebo|Placebo injection
15814045|NCT04333719|Other|Type of sedations|Estimate the prevalence of deep sedations (i.e. with a -4 or -5 score at the Richmond scale at the induction time) for patients in terminal phase and receiving cares from a specialized palliative care facility
15814049|NCT04333693|Procedure|Vascular surgery|Open vascular, endovascular or hybrid procedures
15814050|NCT04333680|Diagnostic Test|Focused Assessment of Sonography for Trauma Exam|Speed and image quality of ultrasound exams performed with either transducer specified in the arms.
15814162|NCT04332783|Other|No Intervention|There are no interventions or exposures of interest in this observational study.
15814555|NCT04329494|Device|Nebulizer with High-Pressure Injector|The nebulizer turns the chemo therapy drugs into a fine mist
15814051|NCT04333667|Behavioral|Intervention group|The intervention consists of 8 modules. Each week participants get access to a new module. Each module consists of psychoeducation and exercise parts. Most of the exercises are based on audio records. The content of the modules includes such themes as awareness and nonjudgement of senses, emotions, and thoughts. Participants can reach a psychologist on demand.
15814052|NCT04333654|Drug|Hydroxychloroquine SAR321068|Pharmaceutical form:Tablet Route of administration: Oral
15814053|NCT04333654|Drug|Placebo|Pharmaceutical form:Tablet Route of administration: Oral
15814054|NCT04333628|Drug|chloroquine|oral treatment of chloroquine
15814055|NCT04333628|Other|standard care|Currently, there is no specific treatment for novel coronavirus. The treatment is mostly supportive in character and is given, based on patient's clinical state. Antibiotics do not help patients fight novel coronavirus.
15814056|NCT04333615|Behavioral|Exercise|Three conditions will be tested: self-selected exercise, walking with pain exercise, and control session.
15814057|NCT04333602|Diagnostic Test|Urinary culture and treatment if asymptomatic bacteriuria is detected|Urinary culture: post- bladder catheter removal, three weeks post-transplant and before double-J ureteral stent removal. Based in the assigned group If we detect asymptomatic bacteriuria specific treatment will be instituted or No treatment.
15814058|NCT04333589|Drug|Favipiravir|On the 1st day, 1600mg each time, twice a day; from the 2nd to the 7th day, 600mg each time, twice a day. Oral administration, the maximum number of days taken is not more than 14 days.
15814064|NCT04333563|Device|CPAP|Continuous positive airway pressure
15814065|NCT04333563|Device|NIV NAVA|Non-invasive neurally adjusted ventilatory assist
15814066|NCT04333550|Drug|Deferoxamine|Intravenous infusion of Deferoxamine
15814067|NCT04333537|Procedure|Computed Tomography (CT)|Undergo SPECT/CT scan
15814068|NCT04333537|Drug|Imaging Agent|Receive imaging agent via injection
15814069|NCT04333537|Procedure|Neck Dissection|Undergo standard elective neck dissection
15814070|NCT04333537|Procedure|Planar Imaging|Undergo planar imaging
15814071|NCT04333537|Procedure|Sentinel Lymph Node Biopsy|Undergo SLN biopsy
15814072|NCT04333537|Procedure|Single Photon Emission Computed Tomography|Undergo SPECT/CT scan
15814073|NCT04333511|Device|TPS (NEUROLITH)|6 treatments of TPS over 2 weeks
15814074|NCT04333511|Device|Sham-TPS (NEUROLITH)|6 treatments of Sham-TPS over 2 weeks
15814075|NCT04333498|Behavioral|Feedback on DBS Concentrations|The study team will examine the feasibility and acceptability of a feedback system based on DBS concentration amounts.
15814076|NCT04333485|Other|Telephonic Active case finding|Standardised WHO-recommended TB symptom screen questionnaire will be administered to TB patients by existing health workers at the RNTCP via telephone calls at 6 and 12 months post-treatment completion. The TB patient (index case) will also be asked about any TB symptoms among household (HH) contacts. All HHs with suspected TB among the index TB case or a HH contact will be visited by RNTCP health workers to collect spot sputum specimens at their home.
15814077|NCT04333485|Other|House Hold Active Case Finding (HHACF)|Existing health workers at the RNTCP TB Units will visit all patient homes at 6 and 12 months post-treatment completion. They will administer standardised WHO-recommended TB symptom screen questionnaire (amended to include cough of any duration) to treated TB cases and their HH contacts. All those with any TB symptom will have a spot sputum taken at the home.
15814078|NCT04333472|Drug|Piclidenoson|Piclidenoson 2 mg orally every 12 hours for up to 28 days
15814079|NCT04333472|Drug|Placebo|Placebo orally every 12 hours for up to 28 days
15814080|NCT04333459|Biological|Hataan DNA Vaccine/Puumala DNA Vaccine|Vaccine compared in High and Lose Doses.
15814081|NCT04333433|Device|PRESERFLO® MicroShunt|Device surgically implanted
15814082|NCT04333433|Procedure|Trabeculectomy|The procedure involves removal of a small portion of the trabecular meshwork and adjacent scleral tissue. Aqueous humor then drains into the subconjunctival space, creating a bleb on the external part of the eye, where it diffuses away.
15814083|NCT04333420|Drug|SOC + IFX-1|SOC + IFX-1
15814084|NCT04333420|Drug|SOC + Placebo|SOC + Placebo
15814085|NCT04333407|Drug|Aspirin 75mg|• If patient not on aspirin, add aspirin 75mg once daily unless contraindicated.
15814086|NCT04333407|Drug|Clopidogrel 75mg|• If patient not on clopidogrel or equivalent, add clopidogrel 75mg once daily unless contraindicated
15814087|NCT04333407|Drug|Rivaroxaban 2.5 MG|"If patient not on an anticoagulation, add rivaroxaban 2.5mg bd unless contraindicated
~If patient on DOAC then change to rivaroxaban 2.5mg unless contraindicated"
15814088|NCT04333407|Drug|Atorvastatin 40mg|• If patient not on a statin, add atorvastatin 40mg once daily unless contraindicated
15814089|NCT04333407|Drug|Omeprazole 20mg|• If patient not on a proton pump inhibitor, add omeprazole 20mg once daily.
15814090|NCT04333394|Dietary Supplement|Probiotic|The probiotic capsules will be administrated once a day. medication with Ritalin starts at the onset of the study in a dose-dependent manner and simultaneous with probiotic supplementation.
15814091|NCT04333394|Other|Placebo|The placebo capsules will be administered once a day. medication with Ritalin starts at the onset of the study in a dose-dependent manner and simultaneous with placebo supplementation.
15814092|NCT04333381|Other|Educational and organizational intervention|"Patients included after a systematic educational and organizational intervention for early diagnosis and care in myocardial infarction, aimed at emergency nurses of a tertiary Hospital capable in primary PCI.
~The educational intervention will consist:
~Systematized educational intervention on acute myocardial infarction for emergency triage nurses will consist of theoretical and practical training through case presentations and clinical simulation.
~The organizational intervention will consist:
~Development and dissemination of an early diagnostic tool for acute myocardial infarction: STEMI infographics. It will be provided to all emergency nurses and emergency triage boxes
~Update the STEMI hospital protocol and adapt it to the current clinical guidelines of the European Society of Cardiology (ESC)
~Review organizational strategies and definition of new improvement measures
~Audit the delays in STEMI
~Periodic multi-disciplinary update sessions"
15814093|NCT04333381|Other|Common Practice|Common practice is based on care by emergency nurses who did not receive any systematized education of acute myocardial infarction led by interventional cardiology nurses. On the other hand, emergency management is based on Plan-Do-Study-Act methodology and in the historical sample some organizational improvement strategies did not exist or were beginning to be implemented
15814094|NCT04333368|Biological|Umbilical cord Wharton's jelly-derived human|Umbilical cord Wharton's jelly-derived human MSC (at the dose of 1 Million / kg) will be administered via a peripheral or central venous line over 60 minutes, using tubing with a 200-μm filter. Cells, in a 150 mL volume, will be delivered at D1 - D3 - D5.
15814095|NCT04333368|Other|NaCl 0.9%|NaCl 0.9% (150 mL) given via an intravenous route at D1 - D3 - D5
15814096|NCT04333355|Biological|Convalescent Plasma|Along with the administration of convalescent plasma, patients will continue to receive supportive standard care.
15814097|NCT04333342|Device|heart rate monitoring using wearable devices|Using Fitbit (TM) wearable devices, heart rate, activity data are collected. Based on these data, resting heart rate is monitored daily basis. If resting heart rate increase beyond set range, users are notified to visit the hospital.
15814098|NCT04333329|Device|NEUROLITH|transcranial pulse stimulation (TPS)
15814099|NCT04333316|Procedure|large head|implantation of large head total hip
15814100|NCT04333316|Procedure|dual mobility cup|implantation of dual mobility total hip
15814101|NCT04333303|Other|Implementation of a complex regional Advance Care Planning program|"Sustainable implementation of ACP at micro- (qualification of professional ACP facilitators to lead conversations in cooperation with family physicians), meso- (qualification of relevant co-actors, organisational development of participating institutions) and macro-level (regional ACP steering group and network), ensuring that valid ACP is encouraged, facilitated, documented, known and honored.
~Core of the intervention is a modular 9-day-training for ACP facilitators. These will be preferably located in regional pools, serving more than one nursing home, and reimbursed, if certified, by German sickness funds based on recent legislation (§ 132g Social Code Book [SGB] V: 1 full-time facilitator for 400 residents). ACP conversations will be offered to all residents. Regional intervention at meso- and macro-level comprises various formats of specific ACP training and information for leadership and staff, and aims to support professional change management."
15814102|NCT04333290|Drug|[11C]MeDAS|PET radiotracer
15814103|NCT04333277|Other|Probiotic|Patients with major depression (both sexes) will receive capsules with 1 × 10^9 CFUs of Lactobacillus helveticus in addition to a conventional antidepressant treatment for 8 weeks.
15814104|NCT04333277|Other|Maltodextrin|Patients with major depression (both sexes) will receive capsules of placebo (maltodextrin) in addition to a conventional antidepressant treatment for 8 weeks
15814105|NCT04333264|Procedure|suction drainage|After primary total hip arthroplasty closed suction drainage will be used.
15814106|NCT04333264|Procedure|no suction drainage|After primary total hip arthroplasty closed suction drainage won't be used.
15814107|NCT04333251|Biological|high-titer anti-Sars-CoV-2 plasma|Recipients will receive 1-2 units of ABO matched donor plasma at neutralization antibody titer >1:64 vs best supportive care
15814108|NCT04333251|Other|oxygen therapy|oxygen therapy
15814109|NCT04333238|Other|New progress note template|Residents assigned to document with new progress note template
15814110|NCT04333238|Other|Standard progress note template|Residents assigned to document with standard progress note template
15814111|NCT04333225|Drug|Hydroxychloroquine|Weekly treatment in individuals at high risk
15814112|NCT04333212|Device|DR. Chip HPV genotyping IVD kit|HPV typing by gene chip
15814113|NCT04333199|Behavioral|Timely|Email
15814114|NCT04333199|Behavioral|Transparency|Email
15814115|NCT04333199|Behavioral|Foot-in-the-door|Email
15814116|NCT04333186|Other|Data from ultrasound measurements|Data from ultrasound measurements and from the electronic patient record will be obtained / analyzed. One additional blood sample will be obtained within 24 hours after inclusion, during planned blood collection (from arterial line or venous puncture).
15814117|NCT04333173|Procedure|endovascular procedure|Endovascular therapies for erectile dysfunction
15814118|NCT04333160|Drug|JTA-004|Patients will undergo a single intra-articular injection of JTA-004 into the knee joint
15814119|NCT04333160|Device|Hylan G-F 20|Patients will undergo a single intra-articular injection of Hylan G-F 20 into the knee joint
15814120|NCT04333160|Other|placebo|Patients will undergo a single intra-articular injection of placebo into the knee joint
15814121|NCT04333147|Biological|Otilimab (GSK3196165)|GSK3196165 solution in vial/pre-filled syringe (PFS) and auto injector (AI) to be administered SC.
15814122|NCT04333147|Drug|csDMARD(s)|Stable dose of csDMARD(s) as standard of care (SoC).
15814123|NCT04333134|Drug|SHR3162|Fluzoparib, also known as SHR3162, is an inhibitor of human PARP
15814124|NCT04333121|Other|weight|we can monitoring the growth of the infants by weight gain degree
15814125|NCT04333108|Drug|Masitinib|Masitinib 6 mg/kg/day
15814126|NCT04333108|Other|Placebo|Matching placebo
15814127|NCT04333108|Other|Best Supportive Care|Optimal concomitant symptomatic treatments. Includes: H1- and H2-antihistamines, proton pump inhibitors (PPI), sodium cromoglycate, antidepressants, leukotriene antagonists and corticosteroids.
15814128|NCT04333095|Drug|Liposomal bupivacaine|Sternal Block during Coronary Artery Bypass Graft Surgery and/or surgical aortic valve replacement through mini- or full sternotomy
15814129|NCT04333095|Drug|Normal Saline Flush, 0.9% Injectable Solution_#1|Sternal Block during Coronary Artery Bypass Graft Surgery and/or surgical aortic valve replacement through mini- or full sternotomy
15814130|NCT04333082|Other|Data collection|"collection of patient data
~Data collection (demographics, prehospital management, duration of ICU and hospital stay, destination at discharge, date(s) of seizure(s), electroencephalographic (EEG) data, seizure history and etiology, number and duration of SE episodes, medication, types of SE according to the current guidelines from the International League of Epilepsy (ILAE), neuroimaging features, comorbidities, laboratory parameters, complications during and after SE , laboratory testing, vital signs, fluid balance) will be performed from the digital medical records, the electroencephalographic and microbiologic database of patients"
15814131|NCT04333069|Procedure|cataract surgery|cataract surgery in form of phaco emulsification or irrigation aspiration
15814588|NCT04329195|Drug|2: continuation of RAS blocker therapy|continuation of RAS blocker therapy
15814132|NCT04333056|Other|Biometric measurement agreement|Patients scheduled for cataract surgery were measured with both ss-OCT devices. The following biometry parameters were compared: anterior keratometry, central corneal thickness (CCT), anterior chamber depth (ACD), lens thickness (LT) and axial length (AL).
15814133|NCT04333043|Diagnostic Test|audiological test, cognitive questionnaires|administration of cognitive and quality of life questionnaires and audiological test
15814134|NCT04333030|Other|questionnaire|Tobacco Use and Risk Questionnaire
15814135|NCT04333017|Device|Percutaneous radiofrequency ablation of parietal endometriosis|Treatment is carried out under local anaesthesia after surgical asepsis, in interventional radiology room. Radiofrequency needles are inserted percutaneously under ultrasound guidance. Number of needles depends on the size of lesion (1 or 2 or 3 needles). In case of proximity between lesion and peritoneum, artificial ascites can be performed. Treatment is carried out in accordance with device's instructions for use (thyroid nodules treatment algorithm), with a gradual increase in power every 5 minutes, without exceeding the maximum authorised power (depending on number and length of needles). State of coagulation is monitored under visual ultrasound control of ablation area (diffusion of Co bubbles), until a decrease in effective power is obtained. Several ablation zones are performed on the same nodule with overlapping of the different impacts. An ice pack is applied to the treated area. An analgesic PO treatment of step 1 and/or 2 is prescribed for 5 days.
15814136|NCT04333004|Drug|Pembrolizumab Combined With Chemotherapy|Pembrolizumab and chemotherapy are carried out at the same time for every 3 weeks
15814137|NCT04332991|Drug|Hydroxychloroquine|"Hydroxychloroquine is available in 200 mg oral tablets of hydroxychloroquine sulfate.
~For this COVID-19 trial, we will use an oral or enteral dose of hydroxychloroquine 400 mg twice daily on the day of enrollment, then 200 mg twice daily for the next 4 days for a 5 day total course."
15814138|NCT04332991|Drug|Placebo|Participants randomized to the control group will receive a dose of placebo enterally twice daily for 5 days (a total of 10 doses). The placebo pills will be as similar as possible to the hydroxychloroquine pills to ensure blinding.
15814139|NCT04332978|Drug|Fluticasone Propionate|
15814140|NCT04332965|Procedure|Non-Surgical Periodontal Treatment|Scaling and root planing and polishing with specific curettes were performed to patients and oral hygiene education was provided to each patient.
15814141|NCT04332939|Other|transcranial direct current stimulation|real tDCS sessions
15814142|NCT04332939|Other|Physical exercise|Aerobic exercise and physical training combined with sham tDCS
15814143|NCT04332926|Other|Tobacco product administration and assessment|4 sample puffs, followed by a 60 minute rest period, hypothetical drug purchase tasks, followed by progressive ratio tasks (single product and two products, with 60 minute rest in between) where participants work to earn puffs of tobacco products; preceded and followed by physiological and subjective assessment
15814144|NCT04332900|Device|Elastic hip strap|The SERF Strap consist of a thin, elastic material that is secured to the proximal aspect of the leg, wraps in a spiral fashion around the thigh, and is anchored around the pelvis. The line of action of the SERF Strap pulls the hip into abdcution and external rotation.
15814145|NCT04332900|Device|Insole|Foot orthoses with semi-rigid arch support and medial elevation at the forefoot and at the rearfoot by 7° each that is made from a block of ethyl vinyl acetate with a thermo-moldable polymer (shore hardness of 45 A) and is manufactured through an automated computer numeric control machine (CNC routers).
15814146|NCT04332887|Behavioral|Multidimensional Exercise Program|Patients in experimental group will receive a 12 week exercise program; patients in control group maintain their usual life activities.
15814147|NCT04332874|Procedure|Isolated Limb Infusion|ILI will be performed within 18 days of initiation of pembrolizumab. ILI (infusion of melphalan and dactinomycin into the affected limb via arterial catheter) will be performed in the interventional radiology suite under anesthesia. In pediatric patients, the pediatric pharmacist w ill be consulted prior to the procedure, and an appropriate prophylactic anti-emetic therapy and dose will be selected for the individual patient.
15814148|NCT04332874|Drug|Pembrolizumab|Pembrolizumab at a dose of 200 mg will be administered intravenously on Day 1 and every 3 weeks(+/= 3 days) thereafter. In adolescent patients, the dosing of pembrolizumab w ill be 2 mg/kg up to a maximum of 200 mg.
15814149|NCT04332874|Drug|infusion of melphalan and dactinomycin|infusion of melphalan and dactinomycin
15814150|NCT04332861|Other|Initial clinical and laboratory evaluation|"Initial evaluation, prior to administration of any antibiotics if possible, includes history, physical exam, and labs including:
~Urinalysis
~Urine culture
~Blood cultures
~Complete blood count with differential
~Comprehensive metabolic panel
~Lactate
~Procalcitonin
~Other inflammatory markers"
15814151|NCT04332848|Drug|ET|Empirical therapy Based on drug history: Levofloxacin sequential therapy or bismuth quadruple therapy (10 or 14 days) or rifabutin triple therapy or concomitant therapy
15814152|NCT04332848|Drug|SGT|Susceptibility testing guided therapy Based on susceptibility test: Levofloxacin sequential therapy or bismuth quadruple therapy (10 or 14 days) or rifabutin triple therapy or concomitant therapy
15814153|NCT04332835|Drug|Plasma|Day 1: CP-COVID19, 250 milliliters. Day 2: CP-COVID19, 250 milliliters.
15814154|NCT04332835|Drug|Standard Therapy|Standard therapy defined by institutional protocol.
15814155|NCT04332822|Drug|R-pola-mini-CHP|"Rituximab 375 mg/m2 iv, day 1, cycle 1. 1400 mg s c OR 375 mg/m2 iv cycles 2-6
~Cyclophosphamide 400 mg/m2 iv, day 1, cycles 1-6
~Doxorubicin 25 mg/m2 iv , day 1, cycles 1-6
~Prednisone, 40 mg/m2 po, days 1-5, cycles 1-6 - round up to nearest 25 mg
~Polatuzumab vedotin 1.8 mg/kg iv day 1 cycles 1-6"
15814156|NCT04332822|Drug|R-mini-CHOP|"Rituximab 375 mg/m2 i.v., day 1, cycle 1. 1400 mg s c OR 375 mg/m2 i. v. cycles 2-6
~Cyclophosphamide 400 mg/m2 i.v., day 1, cycles 1-6
~Doxorubicin 25 mg/m2 i.v., day 1, cycles 1-6
~Vincristine 1 mg i.v. (total dose), day 1, cycles 1-6
~Prednisone, 40 mg/m2 p.o, days 1-5, , cycles 1-6"
15814157|NCT04332809|Procedure|saline-gentamicin irrigation|Layer-by-layer irrigation of the appendectomy wound will be performed using saline-gentamicin solution
15814158|NCT04332809|Procedure|saline irrigation|Layer-by-layer irrigation of the appendectomy wound will be performed using saline solution
15814159|NCT04332796|Drug|Chorhexidine scrub|Chorhexidine scrub was given to patients for 2 weeks
15814160|NCT04332796|Device|ZnO-NPs socks|ZnO-NPs socks was given to patients for 2 weeks
15814161|NCT04332796|Combination Product|Combination of chorhexidine scrub and ZnO-NPs socks|Combination of chorhexidine scrub and ZnO-NPs socks was given to patients for 2 weeks
15814163|NCT04332770|Other|levothyroxine withdrawal|All participants of this study are decided to get radioactive iodine therapy using levothyroxine withdrawal or human recombinant TSH injection prior to the study enrollment. That decision is independent with this study protocol. This study just collect continuous bio signals using wearable devices in the patients undergoing two different preparation methods for radioactive iodine therapy. That is why this study is an observational cohort study.
15814164|NCT04332757|Other|Training intervention.|The investigators have designed a phased 18-week physical development programme to train both rehabilitative and performance enhancement elements of physical preparation. The rehabilitation element of the programme will specifically target pelvic floor function and core strength and stability (known collectively as Core Reconnection training) from weeks 6 to 24 postpartum, and the training element of the programme will contain resistance and high-intensity interval training (HIIT) from weeks 12 to 24 postpartum.
15814165|NCT04332744|Drug|Enzalutamide|Enzalutamide capsules orally once daily and continuously (160 mg) in 28-day cycles (every four weeks)
15814166|NCT04332744|Drug|Talazoparib|Talazoparib capsules orally once daily and continuously (0.5 mg) in 28-day cycles (every four weeks)
15814167|NCT04332731|Device|Symplicity Spyral™ multi electrode renal denervation system|Symplicity Spyral™ multi-electrode renal denervation catheter (Symplicity Spyral catheter, Medtronic) and associated Symplicity G3™ renal denervation radiofrequency generator (Symplicity G3 generator, Medtronic) will be used in this study. The Symplicity Spyral™ multi-electrode renal denervation catheter is intended to deliver low-level radio frequency (RF) energy through the wall of the renal artery to denervate the human kidney.
15814168|NCT04332731|Diagnostic Test|Renal angiogram|Renal angiogram will be used in both treatment and sham groups. Renal angiography is an imaging test used to study the blood vessels in the kidneys. The test will examine the kidney artery anatomy using x-rays following the injection of an x-ray dye (contrast medium). Only patients with eligible renal artery anatomy (between 3 mm and 8 mm) will be randomized ( to treatment or sham groups).
15814169|NCT04332718|Device|Smartphone ECG|Patients who are randomised to the 30-day smartphone ECG monitoring will be contacted within one month from randomisation. Patients will be taught on how to use the smartphone ECG monitoring. Patients are required to monitor their ECG 3 times a day for 30 days. Patients will be contacted during the monitoring period to assess for compliance and to ensure that the recording is done correctly.
15814170|NCT04332705|Diagnostic Test|Detection of Cryptosporidium infection|A biopsy or a surgical sample will be collected from every participant
15814171|NCT04332692|Procedure|Clinical examination centered on congestion|Clinical examination centered on congestion will be performed before discharge from hospital
15814172|NCT04332692|Procedure|Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds|Cardiac, pulmonary, peritoneal, jugular and renal venous Doppler ultrasounds will be performed before discharge from hospital
15814173|NCT04332692|Procedure|Blood sample retrieved for biological assessment and biobanking|Blood sample retrieved for biological assessment and biobanking will be performed before discharge from hospital
15814174|NCT04332692|Procedure|Telephone follow-up|Telephone follow-up will be performed 3 months and 12 months after discharge from hospital
15814175|NCT04332679|Device|Group A - control group|20 patients treated by means of a dense PTFE (d-PTFE) titanium-reinforced membrane (Cytoplast Ti-250XL; Osteogenics Biomedical) and simultaneous implants placement (BT SAFE; Biotec srl, Vicenza, Italy).
15814176|NCT04332679|Device|Group B - Test group|20 patients treated by means of Ti mesh (Trinon Titanium; Karlsruhe, Germany) and cross-linked collagen membrane (Osseoguard, Zimmer Biomet, Warsaw, IN, USA) and simultaneous implants placement (BT SAFE; Biotec srl, Vicenza, Italy).
15814177|NCT04332666|Drug|Angiotensin 1-7|endogenous peptide dilution: angiotensin-(1-7) 0.5 mg / L NaCl 0.9%
15814178|NCT04332666|Drug|Placebos|infusion of NaCl 0.9% without diluted peptide in it
15814179|NCT04332653|Drug|NT-I7|Administered by intramuscular (IM) injection
15814180|NCT04332653|Drug|Pembrolizumab|Administered by intravenous (IV) injection
15814181|NCT04332640|Device|VERITAS Vision System|The investigators or designees will perform routine small-incision cataract surgery via phacoemulsification and use the VERITAS Vision system. The Investigator or designee will then complete a questionnaire regarding the clinical use of the VERITAS Vision system. The system log files automatically generated by the VERITAS Vision system after completion of each surgery will be collected.
15814182|NCT04332627|Drug|Sugammadex|sugammadex 2mg/kg or 4mg/kg according to Train-of-four count (TOF 0 : 4mg/kg, TOF 1-4 : 2mg/kg)
15814183|NCT04332627|Drug|Neostigmine|with glycopyrrolate 0.4mg, neostigmine 0.02mg/kg or 0.04mg/kg or 0.05mg/kg according to Train-of-four count (TOF 0 : wait until TOF 2, TOF2-3: 0.05mg/kg, TOF4: 0.04mg/kg)
15814184|NCT04332614|Behavioral|Less-is-better|Email
15814185|NCT04332614|Behavioral|Social proof|Email
15814186|NCT04332614|Behavioral|Endowment / decision staging|Email
15814187|NCT04332614|Behavioral|Standard email|Email
15814188|NCT04332601|Behavioral|Fatigue Management Therapy|14 sessions of 1h CBT intervention
15814189|NCT04332601|Other|TAU (Treatment as usual)|No CBT intervention
15814190|NCT04332588|Drug|[18F]FMISO PET/MRI imaging|[18F]FMISO PET/MRI imaging
15814191|NCT04332562|Other|dietary restriction (salt restriction)|salt restriction for one week after being diagnosed with hypertension
15814192|NCT04332549|Drug|PICS (Reconstitution Method 1 or 2)|dose: 260mg/m2 Frequency: 2 period cross over study Route of administration : intravenous infusion duration of therapy: 2 cycles of PICS
15814193|NCT04332536|Other|Exercise with and without Codeine|This study will use our novel CPX test that incorporates instantaneous assessment of maximal isokinetic cycling power at V̇O2peak to elucidate the mechanisms that limit V̇O2peak in CHF, and compare these responses with age-matched controls.
15814194|NCT04332523|Drug|JNJ-53718678|Participants will receive a single oral dose of JNJ-53718678 suspension on Day 1.
15814195|NCT04332510|Other|Intact formula|600 ml of infant formula with intact protein
15814196|NCT04332510|Other|Partially hydrolyzed formula|600 ml of infant formula with partially hydrolyzed protein
15814197|NCT04332510|Other|High protein formula|600 ml of infant formula with high protein level
15814198|NCT04332510|Other|Human breast milk|600 ml of breast milk, safe for human consumption
15814287|NCT04331704|Behavioral|Initial Web Survey|Web-based assessment questions regarding alcohol and other substance use and sexual health behaviors
15814199|NCT04332497|Other|"Ibuprofen, Dorifen®; Fentanyl, Talinat®, ''Patient Controlled Analgesia Device''"|Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.
15814200|NCT04332497|Other|"Ibuprofen, Dorifen®; Fentanyl, Talinat®, ''Patient Controlled Analgesia Device''"|Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit
15814201|NCT04332471|Procedure|Radial shockwave therapy|Target intensity will be within a range of 3.5-5.0 bar at maximum Hz, titrated up to patient tolerance within 100 pulses. Total of 3000 pulses.
15814202|NCT04332471|Procedure|Focused shockwave therapy|Target intensity will be within a range of 0.15-0.25 mJ/mm2 at maximum Hz, titrated up to patient tolerance within 100 pulses. Total of 3000 pulses.
15814203|NCT04332471|Device|Shockwave therapy device|The shockwave therapy device will be used to administer either radial or focused shockwave therapy.
15814204|NCT04332471|Other|Home therapy|Stretching and ice massage
15814205|NCT04332458|Behavioral|A focus group interview|this is a qualitative study using focus group interviewing.
15814206|NCT04332445|Other|Hyaluronic Acid Gel|Health care product - to be apllied on the subject's skin
15814207|NCT04332432|Drug|belapectin|intravenous
15814208|NCT04332419|Device|PET/CT|Standard Imaging
15814209|NCT04332419|Device|PET/MR|Additional Imaging
15814210|NCT04332419|Radiation|SIRT with Y-90|SIRT with Y-90 for palliative treatment of the liver malignancy.
15814211|NCT04332393|Drug|Metformin|Metformin tablets according to glycemic control. Initial dose: 425 mg before meals (breakfast, lunch and supper) and 850 mg around 22:00. Modifications may take place according to glycemic control
15814212|NCT04332380|Drug|Plasma|Day 1: CP-COVID19, 250 milliliters. Day 2: CP-COVID19, 250 milliliters.
15814213|NCT04332367|Drug|Carboplatin|Carboplatin IV
15814214|NCT04332367|Drug|Paclitaxel|Paclitaxel IV
15814215|NCT04332367|Drug|Ramucirumab|Ramucirumab IV
15814216|NCT04332354|Other|routine care. No intervention|no intervention
15814217|NCT04332341|Drug|Nicotinamide riboside (NR)|Nicotinamide riboside, PO, 500mgtwice daily for 21, 28, and 35 days
15814218|NCT04332328|Dietary Supplement|Diet|Group of diet types
15814219|NCT04332315|Procedure|Vaginally assisted laparoscopic sacrocolpopexy|"The VALS procedure consists of two steps. First, vaginal hysterectomy or laparoscopically assisted vaginal hysterectomy performed, anterior vaginal wall dissected up to bladder neck starting from initial vaginal incision, posterior vaginal wall dissected from rectum starting from initial vaginal incision up to distal third of posterior vaginal wall.The free arms of fixed meshes are introduced to the peritoneal cavity and the vaginal vault is closed with absorbable polyglactin suture. laparoscopy phase was performed with one intraumbilical (10 mm), 3 lateral abdominal (5 mm) trocars. Two mesh strips fixated to anterior longitudinal ligament of the sacrum with two separate no: 1 polypropylene sutures without tension.
~AS was performed via Pfannenstiel incision after total or subtotal abdominal hysterectomy"
15814220|NCT04332302|Other|Power resistance training|Participants will take part in an intervention of 12 weeks duration in which they will train with musculation machines.
15814221|NCT04332289|Other|Heavy water experiment|3 times daily heavy water (deuterated-water) and mixed meal administration for one week
15814222|NCT04332276|Drug|A-dopamine|"During the phase 1 (titration), it is planned to increase dopamine by maximum 0.25 mg per hour over the daytime period, which corresponds to a maximum increase of 4.5 mg per day (based on the 18 hours of the daytime period, since nocturnal needs are much less important).
~Then, depending on tolerance and efficacy, conservative titration will be continued for a target dose of 30-87 mg per day.
~During the phase 2 (efficacy), the treatment will be maintained at the minimum effective dose, planned between 30 and 87 mg per day, for 30 days."
15814223|NCT04332276|Drug|optimized oral treatment|The patient will received his usual dopaminergic treatment.
15814224|NCT04332263|Other|Neuromuscular Electrical Stimulation - NMES|NMES will be applied through an alternating biphasic current, with a stimulation frequency of 80 Hz and 1 ms pulse duration. Tetanic evoke forces (EF) at a 50% level of a supra-maximal single-pulse peak EF (i.e., 10-12% of a maximal voluntary isometric contraction) will be used. NMES protocol will be performed five times a week, lasting 20 minutes. Muscle fatigue will be evaluated every 5 min of the intervention, and will be used to determine the NMES protocol termination. A 10 % decrease in the single-pulse evoked torque between the evoked force produced pre- and during the NMES protocol will be used to terminate the fatigue protocol.
15814225|NCT04332224|Device|Blanketrol cooling device and water-perfused blankets|Blanketrol and water-perfused blankets
15814226|NCT04332224|Device|Blanketrol and Kool Kit|Blanketrol cooling device with water-perfused vest, hood and lower body blanket
15814227|NCT04332224|Device|Arctic Sun|Arctic Sun cooling device with gel cooling pads
15814228|NCT04332211|Procedure|Hyperbaric Oxygen Therapy|Hyperbaric oxygen therapy (HBOT) utilizes 100% oxygen delivery at a pressure greater than 1 atmosphere for the treatment of various emergent medical conditions.
15814229|NCT04332211|Drug|Pseudoephedrine 60 MG|administer either pseudoephedrine or placebo orally to patients requiring hyperbaric oxygen therapy
15814230|NCT04332211|Drug|Placebo oral tablet|administer either pseudoephedrine or placebo orally to patients requiring hyperbaric oxygen therapy
15814231|NCT04332198|Other|biological test|dyspnea evaluation, ventilatory evaluation and biological test before and after non invasive ventilation
15814232|NCT04332185|Procedure|vestibular socket therapy|(VST) included the following steps. a-traumatic tooth extraction, the socket curetted and rinsed with normal saline thoroughly . One-cm long vestibular access incision was made using a 15c blade 3-4 mm apical to the mucogingival junction at the related socket. A subperiosteal tunnel was created connecting the socket orifice and the vestibular access incision using periotomes and micro periosteal elevators A flexible cortical membrane shield that is made of cortical bone of heterologous origin of 0.6 mm thickness was hydrated and then trimmed and introduced from the vestibular access incision reaching 1 mm below the socket orifice through the tunnel then stabilized using a micro screw to the alveolar bone apical to the base of the socket .
15814233|NCT04332172|Other|General information|General information related to pregnancy is provided electronically.
15814234|NCT04332172|Behavioral|Baseline brief intervention|Interactive brief motivational intervention is delivered electronically. Provides an introduction, describing the purpose and duration, emphasizing the non-judgmental nature of the brief intervention (BI). Uses a high-quality video featuring gain-framed messaging, quit recommendation, and testimonial from a race-matched woman; tailored on race-ethnicity, efficacy, binge frequency, and level of concern regarding her own alcohol use. The e-BI poses a question regarding the participant's willingness to avoid alcohol throughout her pregnancy. Responses to this question will sort participants into one of three major branches, each using motivational principles to promote alcohol abstinence during pregnancy.
15814235|NCT04332172|Behavioral|Remote online booster sessions|Two < 5-minute online e-BI boosters will be sent to participants via text link (one at 6 weeks post-baseline and one at 30 weeks gestation). The boosters will include a brief summary of the prior session in terms of the participant's concerns and goals. It will also include an assessment of her current status regarding (a) use of alcohol, and (b) intentions regarding future use of alcohol. A brief (1-2 minute) video tailored on her current status and prior goal will be provided. Finally, the boosters will contain optional goal-setting regarding reaching or maintaining abstinence.
15814236|NCT04332172|Behavioral|SMS|Tailored text messages (SMS) will be sent to participants twice a week from baseline throughout her pregnancy (or until she opts out). The messages will be tailored on her quit status, goals, efficacy, level of concern, gestation, and perceived advantages of change. Messages will follow current state of the art regarding messaging preferences, tailoring, and gain-framing. The current list includes messages regarding fetal development, nutrition, exercise, and stress management, as well as alcohol.
15814237|NCT04332159|Procedure|Closed nasal fracture reduction|Closed nasal fracture reduction is performed under local anesthesia with addition of Methoxyflurane or placebo
15814238|NCT04332146|Behavioral|Mindfulness-based program (MBI-p-R)|The MBI-p-R was developed in line with the model of Mindfulness-based Stress Reducation (MBSR) proposed by Kabat-Zinn. It will be conducted for 1.5 hours for each session, once a week for 8 weeks. There are four key operational components to be included in each session: engagement and introduction, mindfulness practices, daily life application, and consolidation of learning.
15814239|NCT04332146|Behavioral|Booklet-based psychoeducation|The participants in the control group will be provided a booklet at baseline, including general information in handling every day stress by a new mother, as well as a record for their weekly activities. The contents covered a range of topics including work-stress, balanced diet, physical exercise, sleeping quality, bonding with baby and the treatment for depression. The participants will be contacted by phone call and/or whatsapp weekly for a short talk based on the record and content on the booklet. They will also be asked to record their daily life weekly for discussion.
15814240|NCT04332133|Procedure|laser interference,INTRAVITREAL INJECTION|sub threshold micro pulse laser for DME for group 1 and intravitreal injection of Ranibizumab for group 2
15814241|NCT04332120|Procedure|tubal sterilization|
15814242|NCT04332107|Drug|Azithromycin|Participants will be shipped a single 1.2 g dose of oral azithromycin
15814243|NCT04332107|Drug|Placebos|Participants will be shipped a dose of matching placebo
15814244|NCT04332094|Drug|Tocilizumab|162 mg sc x 2 doses + tocilizumab 162mg sc x 2 doses at 12 hours (day 1)
15814245|NCT04332094|Drug|Hydroxychloroquine|400 mg / 12h v.o. day 1 followed by 200 mg / 12h v.o. for 6 days (7 days in total)
15814246|NCT04332094|Drug|Azithromycin|500 mg / day v.o. for 3 days
15814247|NCT04332081|Device|hyperbaric oxygen therapy (HBOT)|The patient will receive 90 minutes of hyperbaric oxygen at 2.0 ATA with or without airbreaks per the hyperbaric physician. Upon completion of the treatment the patient will then return to the medial unit and continue all standard of care. Additional treatments (up to 5) can be given if warranted and agreed upon by the patient and all members of the team caring for the patient.
15814248|NCT04332068|Drug|Oral ivermectin|Ivermectin (Iver P®) 3 mg tablets are round, white, and scored on one side. Ivermentin 3mg tablets will be crushed and mixed thoroughly in 10mL of water.
15814249|NCT04332068|Drug|Permethrin Cream|permethrin cream 5% (Pioletal® Plus) is a white coloured lotion with a homogenous appearance and an odour of fennel and lavender.
15814250|NCT04332068|Other|Placebo tablet|placebo tablets are round, white, scored on one side. There are no active substances in the placebo tablets.
15814251|NCT04332068|Other|Placebo cream|A placebo cream is a white coloured lotion with a homogenous appearance and an odour of fennel and lavender but lacking the permethrin agent.
15814252|NCT04332055|Other|ERVIN|ERVIN is state of the art for IT systems, which uses artificial intelligence (AI) and real-time patient-specific PRO data to support patients and doctors in clinical decision-making. The system is designed for surgical OA treatment of knee and hip replacement, and can be used to predict outcome scores for the actual choice OA patients face in the patient trajectory; to choose surgery or not.
15814253|NCT04332042|Drug|Tofacitinib|Tofacitinib 10mg twice a day will be administered within 24h from hospital admission for 14 days
15814254|NCT04332029|Behavioral|CBT + WGP + CM|The intervention will be implemented in 8-week group-based sessions and includes: 1) A Cognitive Behavioral Treatment (CBT) for smoking cessation with quit date occurring at sixth session. Patients will be asked to reduce their nicotine intake gradually (i.e., 20% each week); 2) A Weight Gain Prevention module (WGP) which will consist on providing CBT and Dialectical-Behavioral Therapy (DBT) techniques targeting weight stability and associated disordered eating, and 3) a Contingency Management procedure reinforcing smoking abstinence. This component will consist on providing vouchers to reinforce abstinence contingent on biochemical verification. The schedule will incorporate an increasing magnitude of reinforcement.
15814255|NCT04332029|Behavioral|CBT + WGP|The intervention will be implemented in 8-week group-based sessions and will include only the first two components of the experimental intervention: 1) A Cognitive Behavioral Treatment (CBT) for smoking cessation with quit date occurring at sixth session. Patients will be asked to reduce their nicotine intake gradually (i.e., 20% each week); 2) A Weight Gain Prevention module (WGP) which will consist on providing CBT and Dialectical-Behavioral Therapy (DBT) techniques targeting weight stability and associated disordered eating.
15814256|NCT04332016|Other|biological samples collection|collection of whole blood samples, urine and stool samples, upper respiratory samples, post-mortem biopsies
15814257|NCT04332003|Device|Remote Ischemic Conditioning (RIC) Treatment|RIC treatment will be delivered by an automated device that delivers the RIC treatment (manufactured by LifeCuff Technologies).
15814258|NCT04331990|Other|Standard Physcial Therapy|Patients assigned to this group will receive a 40-min multimodal supervised physical therapy treatment comprised of warm-up (10-min cycling/walking), muscle strengthening and stretching, and neuromuscular control exercises. Manual mobilization techniques may be applied as necessary according to the findings of the physical examination. Treating physical therapists will prescribe exercises based on a predetermined list of exercises.
15814259|NCT04331990|Other|Intermittent Mechanical Traction|In addition to the standard treatment, patients in this group will receive intermittent knee joint decompression for 20 minutes. Patients will be lying supine with the knee semiflexed to 30° and supported by a wedge under the knee. A customized leg cuff will be placed around the lower leg and two ropes will be extending horizontally from the cuff to the vertical traction weight using a pulley system to transfer the traction force to the tibiofemoral articulation. The magnitude of the traction force will be between 10-15% of the patient's body weight. The traction force will be applied for 10 application cycles; each cycle comprised of 2 minutes traction followed by 30 seconds relief. This will sum up to 20 minutes of actual joint traction duration. The traction force application and relief time will be controlled manually by the treating therapist. Knee joint traction procedures will be applied at the end of the physical therapy session.
15814260|NCT04331990|Other|Continuous Mechanical Traction|Patients assigned to this group will receive the same treatment protocol as those in the Intermittent Mechanical Traction group. However, the knee traction force will be applied continuously for 20 minutes without intermittent force relief periods.
15814261|NCT04331977|Device|Maxillary Expansion|2 appliances to expand the maxillary arch
15814262|NCT04331964|Procedure|partial pulpotomy|Removal of a small portion of coronal pulp tissue after exposure, followed by application of a biomaterial directly onto the remaining pulp tissue prior to placement of a permanent restoration.
15814263|NCT04331951|Diagnostic Test|Targeted biopsy within Sydney protocol|Biopsy at suspicious GIM lesions at any area of antrum (both lesser and greater curvature site), body (both lesser and greater curvature site) and incisura. If there is no abnormal mucosa seen at any site, random biopsy will be performed.
15814264|NCT04331938|Drug|Regional anesthetic SPG block-bilateral|Patients will receive a 5mL injection comprised of 4.5mL 1% bupivacaine and 0.5mL of dexamethasone (10mg/mL) directed towards the sphenopalatine ganglion on each side (5 mL on each side)
15814265|NCT04331925|Behavioral|Anxiety and depression screening|At the time of consent, the participant parent will be randomized into either the control or intervention groups. The control group will complete the Hospital Anxiety and Depression Scale (HADS) questionnaire at the start of the study. After two weeks or at the time of discharge, the control group will complete the HADS questionnaire again.
15814266|NCT04331925|Behavioral|Journaling|Parents randomized into the intervention group be given verbal instructions to use a journal how/when they choose for the duration of the intervention period
15814267|NCT04331899|Drug|Peginterferon Lambda-1a|Peginterferon Lambda-1a (180 ug subcutaneous injection) single dose along with Standard of Care
15814268|NCT04331899|Other|Placebo|Placebo subcutaneous injection along with Standard of Care Treatment for COVID-19 Infection
15814269|NCT04331873|Diagnostic Test|Ultrasound|An ultrasound will be obtained prior to obtaining the standard contrast injection to determine if this imaging modality is equivocal.
15814270|NCT04331834|Drug|Hydroxychloroquine|"Hydroxychloroquine with the following dosage:
~day 0: 400 mg (2 tablets)
~day 1: 400 mg (2 tablets)
~day 2: 400 mg (2 tablets)
~day 3: 400 mg (2 tablets)
~weekly: 400 mg (2 tablets) for a period of six months"
15814271|NCT04331834|Drug|Placebos|"Placebo with the following dosage:
~day 0: 400 mg (2 tablets)
~day 1: 400 mg (2 tablets)
~day 2: 400 mg (2 tablets)
~day 3: 400 mg (2 tablets)
~weekly: 400 mg (2 tablets) for a period of six months"
15814272|NCT04331808|Drug|Tocilizumab|Tocilizumab 8mg/kg D1 and if no response (no decrease of oxygen requirement) a second injection at D3.
15814273|NCT04331795|Drug|Tocilizumab|"Group A: Tocilizumab (beginning dose 200mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.
~Second dose is provisioned if:
~Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND
~CRP decrease is < 25% at 24 hours following tocilizumab administration and CRP > 40mg/L"
15814274|NCT04331795|Drug|Tocilizumab|"Group B: Low-dose tocilizumab (beginning dose 80mg) Single dose is provisioned, patient is eligible to receive up to two doses, with re-evaluation of clinical and biochemical responses performed every 24 hours.
~Second dose is provisioned if:
~Increasing supplemental oxygen requirement or Tmax higher than baseline in the 24h following initial tocilizumab administration AND
~CRP decrease is < 25% at 24 hours following tocilizumab administration and CRP > 40mg/L"
15814279|NCT04331743|Drug|Liposome-entrapped Mitoxantrone Hydrochloride Injection|Intravenous infusion
15814280|NCT04331730|Drug|AKST4290|Oral AKST4290
15814281|NCT04331730|Drug|Placebo|Oral placebo
15814282|NCT04331730|Drug|Aflibercept|Aflibercept intravitreal injection
15814283|NCT04331717|Device|Bead Block 300-500 um|These patients will undergo embolization with 300-500µm Bead Block particles.
15814284|NCT04331717|Behavioral|Weight Management|All participants will be enrolled in weight management through the Johns Hopkins Weight Management Center. During weeks -4 through 0, participants will be required to go to weekly visits. Weight management will include counseling on diet, exercise and behavior change. Food programs, pharmacotherapy and other procedures will not be utilized.
15814285|NCT04331717|Drug|Lupron|22.5 mg will be given as a single intramuscular or subcutaneous injection once every 12 weeks according to the standard of care for prostate cancer. If leuprolide acetate, 22.5 mg for 3-month administration is not available, a suitable substitute may be allowed upon approval by the principle investigator
15814286|NCT04331704|Drug|PrEP acronym (pre-exposure prophylaxis)|A daily tablet containing 245 mg of tenofovir disoproxil fumarate and 200 mg emtricitabine (Truvada; Gilead Sciences) for up to 30 days.
15814288|NCT04331704|Behavioral|Interactive Voice Response (IVR) monitoring|Daily telephone-based assessment on alcohol and other substance use, sexual health behavior and PrEP taking
15814289|NCT04331704|Behavioral|Educational material on alcohol and sexual health behavior|Educational material to provide information, resources and techniques to enhance awareness regarding alcohol and other substance use, along with sexual health behavior.
15814290|NCT04331704|Behavioral|Interactive Voice Response (IVR) assessment with personalized information|Daily telephone-based assessment on alcohol and other substance use, sexual health behavior and PrEP taking with personalized and information based on daily IVR responses
15814291|NCT04331704|Behavioral|Personalized information based on web-based survey responses & standardized information|Personalized and information on alcohol use and sexual health behavior based on responses to the web-based survey along with standardized information.
15814292|NCT04331691|Drug|Spironolactone|After randomization, this group will receive 12.5 mg of spironolactone daily. Subjects who did not reach the target blood pressure after 4 weeks of treatment should be increased to 25 mg of spironolactone. After 12 weeks of treatment, study will be end.
15814293|NCT04331691|Drug|Amiloride|After randomization, this group will receive 5 mg of amiloride daily. Subjects who did not reach the target blood pressure after 4 weeks of treatment should be increased to 10 mg of amiloride. After 12 weeks of treatment, study will be end.
15814294|NCT04331678|Behavioral|Comparator App|"Participants will download and agree to use the study app at least once per week during the 3-month intervention period.
~The app allows participants to invite a network of friends and family to provide emotional and logistical support during their treatment."
15814295|NCT04331665|Drug|Ruxolitinib|Ruxolitinib is an inhibitor of JAK1 and JAK2 (proteins important in cell signalling) approved for the treatment of myelofibrosis, polycythemia vera, and graft-versus-host disease.
15814296|NCT04331652|Procedure|Polypectomy without anesthesia or analgo-sedation|"Premedication: paracetamol 1g oral. Patient will undergo polypectomy without anesthesia. During the procedure, pain will be monitored using a pain assessment scale from 0 to 10 (0 meaning no pain and 10 meaning maximum pain imaginable). At any time, if the patient express a pain strictly superior to 4 an analgo-sedation will be proposed and/or general anesthesia.
~Pulse and blood pressure will be monitored. Assessment of patient satisfaction after the intervention."
15814297|NCT04331639|Dietary Supplement|vitamin D3|Subjects will receive oral high dose interval vitamin D3, concurrently when they are receiving their biologic treatment for their inflammatory bowel disease every 4-8 weeks.
15814298|NCT04331626|Drug|Gemcitabine Injectable Product|Low dose chemotherapy drug combined with pd-1 antibody, Gemcitabine should be administered at 50% of the recommended dose, i.e. 500mg/m2, for 30 minutes by intravenous drip. Day 1 and day 8 administration.
15814299|NCT04331613|Biological|CAStem|CAStem will be administered intravenously.
15814300|NCT04331600|Drug|Chloroquine phosphate|Oral chloroquine phosphate for 14 days
15814301|NCT04331600|Other|Telemedicine|Telemedical supervision for 42 days
15814302|NCT04331587|Device|BF-P190 4 mm thin bronchoscope|"EVIS EXERA III Bronchofiberviedoscopes
~Olympus"
15814303|NCT04331587|Device|BF-MP190F 3 mm ultrathin bronchoscope|"EVIS EXERA III Bronchofiberviedoscopes
~Olympus"
15814304|NCT04331587|Device|Radial ultrasound probe (UM S20-17S)|-Olympus
15814305|NCT04331587|Device|PeriView FLEX 21G Single Use Aspiration Needle|"NA-403D-2021
~Gyrus ACMI, Inc."
15814306|NCT04331561|Behavioral|sensory re-weighting|Participants will be supported in quiet standing by a safety harness and crisscrossing strap system. A cervical collar will be used to maintain consistent alignment between the head and trunk. A virtual reality headset is used to create a virtual environment in which visual stimuli will be presented. Three different body positions will be used during training: earth-vertical and clockwise and counterclockwise tilted 16º in the frontal plane. Sensory re-weighting will be driven by priming upregulation of somatosensory cues. In each training trial, participants must determine the direction of gravity and then indicate if the rod being displayed is aligned with gravity or if it needs to rotate clockwise or counterclockwise for that to be so. Participants will be instructed to pay attention to what they feel from their feet, legs, and gut during training and to use that pressure, stretch, movement, and muscle tension feedback to help them sense gravity.
15814307|NCT04331535|Diagnostic Test|Polygenic risk score (PRS)|Polygenic risk score report from a Clinical Laboratory Improvement Amendment (CLIA)-certified laboratory for coronary artery disease, atrial fibrillation, type 2 diabetes, colorectal cancer, breast cancer (for women only), and prostate cancer (for men only), delivered along with patient- and provider-level educational material.
15814308|NCT04331522|Diagnostic Test|Oral provocation test|Titrated provocation with allergen
15814309|NCT04331509|Other|No Intervention|No Intervention
15814310|NCT04331496|Other|Hypertonic solution|Hypertonic serum 4 ml 3%, administered for 8 minutes in a Philips® vibrating mesh nebulizer plus 20 minute session of Respiratory Physiotherapy based on slow expiratory flow: passive technique of expiratory aid applied to the participant by means of a slow thoracic-abdominal pressure that begins at the end of a spontaneous expiration and continues until the residual volume. The physiotherapist through assisted cough or stimulation of the trachea achieves expectoration of sputum.
15814311|NCT04331496|Other|Physiological solution|Single-dose physiological saline serum (5 ml 0.9% NaCl), administered for 8 minutes in a Philips® vibrating mesh nebulizer plus 20 minute session of Respiratory Physiotherapy based on slow expiratory flow: passive technique of expiratory aid applied to the participant by means of a slow thoracic-abdominal pressure that begins at the end of a spontaneous expiration and continues until the residual volume. The physiotherapist through assisted cough or stimulation of the trachea achieves expectoration of sputum.
15814312|NCT04331483|Other|Physical activity program|"Supervised sessions of at least 15 minutes 4 times a Week combined with unsupervised sessions.
~The supervised activities include moderate-intensity aerobic activities (exercise bike), muscle strengthening (dumbbells, elastic bands, medicine balls) and playful situations (ball games, cooperative games, body expression games).
~Each patient can also do unsupervised sessions, autonomously, on the bike thanks to a smartphone application developed by the Kiplin company, with challenges to be carried out by teams of 2 to 5 people (team including several patients, possibility to include relatives) over periods of 1 to 3 weeks per challenge."
15814313|NCT04331470|Drug|Levamisole Pill + Budesonide+Formoterol inhaler|Levamisole 50 mg tablet has to be taken 1-2 tablets every 8 hours Budesonide+Formoterol has to be inhaled 1-2 puff every 12 hours
15814314|NCT04331470|Drug|Lopinavir/Ritonavir + hydoxychloroquine|Hydroxy Chloroquine 200mg single dise Lopinavir/Ritonavir 2 tablets every 12 hours
15814315|NCT04331457|Radiation|Brain magnetic resonance imaging (MRI) , computed tomography (CT)|imaging
15814316|NCT04331444|Device|CGM|Using the CGM during the entire study period of 12 months.
15814317|NCT04331444|Behavioral|training course|The participants in the three groups will attend a three-hour training course with different content depending on the group allocation. The aim of this training course is to ensure that the participants have the knowledge, support and confidence to work collaboratively with their HCPs to increase TIR and decrease HbA1c.
15814318|NCT04331444|Behavioral|Peer-support|The peer-support will be facilitator-led by the primary investigator with peer exchange in group sessions (3 sessions over the study period, 3 hours per session) with 6-8 participants in every group.
15814319|NCT04331431|Procedure|Spinal cord tumor resection|Excision of intradural tumors
15814320|NCT04331418|Drug|Dexmedetomidine|1 mcg/kg IV over 10 minutes followed by 0.5 mcg/kg/hr
15814321|NCT04331418|Procedure|caudal block|After negative aspiration of blood or cerebrospinal fluid, 2 mg/ kg of bupivacaine at concentration of 0.5% (volume 0.5ml/kg) was given as per the group assigned, then the site of injection was dressed, and the patient was turned supine.
15814322|NCT04331405|Biological|Human Allogeneic Umbilical Cord Blood Mononuclear Cells (hUCBMCs) systemic (i.v.) infusions|"HUCBMCs samples were prepared for infusion in the specialized laboratory of Cord Blood Bank (CryoCenter Ltd) and transported to the clinic immediately within 2 hours in the Dry Shipper. All samples were chosen according to patients blood group and rhesus-factor.
~All samples were examined for hemotransmissive infections and cell viability prior to the preparation.
~Obtained samples were infused through the blood transfusion systems with additional filter after 3 tests for biological and individual compatibility and tolerance.
~Each patient of the pilot group received 4 cell infusions (1 infusion per week) with 1 week interval during the in-hospital treatment."
15814323|NCT04331392|Behavioral|Spatial Navigation Intervention|"The 16-week intervention is completed daily, 5 days/week, remotely from home on a designated study website. Each week participants learn a new city through navigation tasks which increase in difficulty day-to-day and have a total of 4 levels of difficulty, with the goal of being able to independently navigate the city by the end of the week via Google Street View. Participants complete end-of-day multiple-choice tasks, testing what they learned with 3 types of allocentric questions: 1) predicting the next street/landmark, 2) distance judgement and 3) vector mapping. Participants also complete a map placement task, which involves reporting the locations of all studied landmarks/streets.
~Participants are presented with auditory rewards in the forms of short audio clips about landmarks, written encouragement in the form pop-ups (e.g., Good work, keep it up!), and coffee card rewards based on adherence to the intervention (e.g.,$5 bi-weekly if 100% of intervention is completed)."
15814324|NCT04331392|Behavioral|Educational Videos|The 16-week active control, remote video intervention is completed daily, 5 days a week by participants on a designated website. Participants placed in the active control group are trained on educational topics by watching videos of Ted Talks, to control for the effects of generalized environmental enrichment of the same dose as targeted navigation training. For each day of training, participants are asked to select between an option of 2 possible videos, watching a total of three videos per day. To ensure compliance and sufficient attention to the videos, at the end of each video, participants are asked to rate 5 aspects of the content (relevance, interest, comprehensibility, complexity, informative), and speaker (persuasiveness, quality of delivery, facial expression, convincingness, captivation), on a scale of 1 (lowest) to 5 (highest). Additionally, as with remote navigation participants, they are given written and monetary rewards.
15814325|NCT04331379|Device|Nasal Elevator|A device aiming to elevate the clefted nostril extraorally and fixed on the forehead.
15814326|NCT04331379|Device|Taping Alone|Horizontal tape alone.
15814327|NCT04331366|Device|GO2 PEEP MOUTHPIECE|The GO2 PEEP MOUTHPIECE has a bidirectional valve that delivers PEEP with each breath. Participants will be provided a G02 PEEP MOUTHPIECE to use underneath the oxygen face mask and will be instructed to breathe slowly and deeply through the mouthpiece for 15 minutes total. Metrics for primary and secondary endpoints will be recorded immediately prior to use and then at 5, 10 and 15 minutes of use and then 15 minutes after cessation of use.
15814328|NCT04331353|Behavioral|Comparator 1 (tailored approach)|Tailored to a child's sensitization status. Components include, education, cockroach baiting, mattress and bed covers, high efficiency particulate air (HEPA) vacuum cleaner, air purifier.
15814329|NCT04331353|Behavioral|Comparator 2 (insecticidal bait)|Cockroach bait
15814330|NCT04331340|Other|Pharmacist review of LUTS|Pharmacist review and recommendations, including education, behaviour, lifestyle, or medications
15814331|NCT04331340|Other|Pharmacist Provision of healthy aging leaflets|Pharmacist will inquire about presence of LUTS and provide patient with healthy aging leaflets
15814332|NCT04331327|Drug|allogenic lyophilized growth factors|Prior to usage, reconstitution of the product was done using 1-ml saline and 1-ml lignocaine followed by gentle vial rubbing for 3 minutes. Then, the mixture was kept at ambient temperature for 5 minutes to ensure complete protein re-hydration.
15814333|NCT04331314|Device|Use of Symbios Bone Graft Material|Patients will receive Symbios Bone Graft Material according to randomization Group.
15814334|NCT04331314|Device|Algipore Bone Substitution Material|Patients will receive Algipore Bone Substitution Material according to randomization Group.
15814335|NCT04331301|Procedure|Bipolar Vapo-Enucleation of the prostate|group A: Patient will be subjected to bipolar endoscopic enucleation of the prostate by vaporization electrode (vapoenucleation).
15814336|NCT04331301|Procedure|Bipolar Needlescopic Enucleation of the prostate|group B: Patient will be subjected to bipolar endoscopic enucleation of the prostate by hot knife electrode (Needlescopic Enucleation ).
15814337|NCT04331288|Drug|PT150|Intervention 1 includes PT150 with alcohol consumption
15814338|NCT04331288|Other|Beverage|The alcohol beverage will be prepared by an in-house pharmacist at the MEDVAMC in a volume of 450 ml for a 70 kg individual and adjusted for body weight by varying the volume. Alcohol will be administered in a concentration of 16% alcohol (Everclear, St. Louis, MO) by volume in juice or another flavored beverage. Participants will be allowed 30 minutes to consume the beverages.
15814339|NCT04331275|Biological|Viral Specific T-cells (VSTs)|VSTs will be infused into solid organ transplant recipients who have evidence of viral infection.
15814628|NCT04328805|Drug|Ibuprofen tablets|oral tablet
15814340|NCT04331249|Procedure|surgery or catheter based cardiac procedure (catheter ablation)|patients with implanted CIED (pacemaker, ICD or CRT) that undergo any surgery or any catheter based cardiac procedure (e.g. radiofrequency ablation)
15814341|NCT04331236|Behavioral|Cognitive Behavioral Therapy|CBT trains individuals to identify and reframe dysfunctional thoughts to help improve mood and behavior. CBT intervention also includes teaching relaxation and mindfulness strategies, as well as ways to help improve functioning through the use of behavioral goal setting.
15814342|NCT04331236|Other|Yoga|Yoga consists of physical exercises, breathing techniques, and meditation designed to condition the physical body, calm the mind, and stabilize emotions.
15814343|NCT04331223|Other|Observation|observational
15814344|NCT04331210|Drug|Diclofenac Sodium|Group 1 will take oral diclofenac sodium and group 2 will take Rectal diclofenac sodium as an analgesic
15814345|NCT04331197|Drug|Clomiphene Citrate 50mg|Clomid 50 mg, 2 tablets orally every day from day 2-5 of the period for 5 days
15814346|NCT04331197|Drug|Letrozole 2.5mg|Femara 2.5 mg, 2 tablets orally every day from day 2-5 of the period for 5 days
15814347|NCT04331184|Procedure|RFA using combined bipolar and monopolar energy deliver|RFA technique combining bipolar mode and switching monopolar mode using dual / Twin Cooled-wet electrodes is performed on residual tumors after transarterial chemo-embolization.
15814348|NCT04331171|Device|Web application users|questionnaire of comorbidity and symptoms completed by the patient on his smartphone
15814349|NCT04331158|Other|Dry cupping therapy|Dry cupping therapy application on the patient's skin
15814350|NCT04331145|Drug|Ticagrelor 60mg|"Platelet reactivity will be assessed by VerifyNow P2Y12 assay in ALL enrolled patients after confirmed use of clopidogrel for 4 days prior TAVI. Patients that have not completed a pre-treatment period of 4 days of clopidogrel will receive a loading dose of 300mg, according to the clinical practice, with assessment of platelet reactivity by VerifyNow P2Y12 at the following 6 hours. Based on results of basal VerifyNow P2Y12 assay at least 24 hours before the index-TAVI procedure, patients with:
~High on-treatment platelet reactivity (PRU ≥ 160 assessed with VerifyNow P2Y12 assay): Patients will be switched to receive ticagrelor 60mg twice daily initiating at least 24hrs before TAVI procedure, in order to arrive to the index TAVI procedure with at least two doses of 60 mg, and will continue with Ticagrelor 60mg twice per day during the following three months."
15814351|NCT04331132|Drug|Tolvaptan 15 MG|vasopressin-2 receptor antagonist 15mg once daily is added-on to the conventional diuretic strategy
15814352|NCT04331119|Drug|Duvelisib|Verastem will supply duvelisib
15814353|NCT04331119|Procedure|Peripheral blood draw|-Prior to transplant, cycle 1 day 1 of duvelisib, and at the time of all imaging studies
15814354|NCT04331106|Diagnostic Test|Online Questionnaire|Online Questionnaire via SoSci Survey
15814355|NCT04331093|Drug|SHR-1210+Apatinib|"Drug: SHR-1210 SHR-1210 will be administered as a 30-minute IV infusion Q2W at a dose of 200mg
~Drug: Apatinib Apatinib tablet will be administered orally,once daily until progression"
15814359|NCT04331067|Drug|Paclitaxel|-Given standard of care
15814360|NCT04331067|Drug|Carboplatin|-Given standard of care
15814361|NCT04331067|Biological|Nivolumab|-Given standard of care
15814362|NCT04331067|Biological|Cabiralizumab|-Will be provided by Bristol Myers Squibb
15814363|NCT04331067|Procedure|Tumor biopsy|-Baseline, week 5, surgery, and at time of relapse (optional)
15814364|NCT04331067|Procedure|Bone marrow|-Time of port placement (baseline), time of surgery, and time of recurrence (optional)
15814365|NCT04331067|Procedure|Blood draw|-Baseline, week 5, prior to surgery , and disease progression (optional)
15814366|NCT04331054|Drug|2: Usual practice + SYMBICORT RAPIHALER|2 puffs bid during 30 days by inhalation
15814367|NCT04331054|Other|1: Usual practice|Usual practice
15814368|NCT04331041|Device|MR-guided stereotactic body radiation therapy|"Will be administered using MRIdian or MRIdian Linac system
~50 Gy in 5 fractions"
15814369|NCT04331041|Drug|Defactinib|-Oral drug 400 mg twice a day
15814370|NCT04331041|Procedure|Tumor biopsy|-Baseline and 12-14 weeks after end of SBRT (or at time of surgery)
15814371|NCT04331041|Procedure|Research blood draw|-Baseline, 6-8 weeks after the end of SBRT, and 12-14 weeks after the end of SBRT
15814372|NCT04331028|Device|Shockwave therapy|A shockwave therapy device will be applied in the alveolar socket area of a maxillary tooth, 2 weeks after tooth extraction was performed.
15814373|NCT04331015|Diagnostic Test|Pure tone audiometry|pure tone audiometry
15814374|NCT04331002|Drug|Zilretta|ZILRETTA is an injectable suspension that delivers 32 mg of triamcinolone acetonide. It is supplied as a single-dose kit containing one vial of ZILRETTA microsphere powder, one vial of 5 mL diluent, and one sterile vial adapter.
15814375|NCT04331002|Other|Placebo|5 mL normal saline
15814376|NCT04330989|Behavioral|iNSC and Adherence supporter training|"Integrated next step counseling: iNSC is a structured, patient-centered approach informed by motivational interviewing techniques, which aims to foster an environment for joint-problem solving in order that the participant may identify their individual needs to increase or sustain sexual health through biomedical and non-biomedical approaches. iNSC frames the counselling sessions as a non-judgmental discussion to explore the facilitators and challenges to sexual health and medication adherence.
~Adherence supporter training: Participants will be asked to identify a partner, family member, or friend to whom they are willing to disclose their HIV status (for HIV-positive women) or their intent to initiate PrEP (for HIV-negative women). Participants may also select a clinic-based peer to serve this adherence supporter role. Trainings will emphasize basic HIV knowledge, importance of antiretroviral adherence, potential drug side effects, and practical strategies for supporting adherence."
15814377|NCT04330976|Behavioral|Nutrition and physical activity intervention|Messages sent on nutrition and physical activity in pregnancy
15814378|NCT04330976|Behavioral|Control|Messages sent on general health during pregnancy
15814418|NCT04330638|Drug|Anakinra|Anakinra will be given as a daily subcutaneous injection of 100 mg for 28 days or until hospital discharge, whichever is first
15814379|NCT04330950|Other|Neurocognitive tests|Preoperative: Battery of neurocognitive tests and questionnaires (MoCA, PHQ-9, Falls History, FIFE, STOPBANG, Nutritional Survey) Postoperative in PACU: NuDESC test Postoperative 30 days: 10 minute phone interview
15814380|NCT04330937|Dietary Supplement|dietetics|90 days of consumption
15814381|NCT04330924|Other|Create Real-life Experience And Teamwork In Virtual Environment (CREATIVE)|3D virtual hospital environment where participants can perform physical and social interaction and presence using avatars.
15814382|NCT04330911|Procedure|Aerobic Exercise|Exercise loading is determined by increasing the heart rate. This loading calculated by Karvonen formulas (maximum %80 of Heart Rate)
15814383|NCT04330898|Device|Biotronik peacemakers, implantable cardioverter-defibrillators and cardiac resynchronizers|Any of these Biotronik cardiac stimulation devices with the Home Monitoring function activated for the remote control of patients
15814384|NCT04330885|Other|Supervised abdominal exercises and stationary biking|Explain pain to the patients in order to minimize fear of movement
15814385|NCT04330872|Drug|Enteric Coated Aspirin Tablet|Study participants will be assigned to receive either EC Aspirin and will be required to continue taking them throughout the study (three days).
15814386|NCT04330872|Drug|Plain Aspirin|Study participants will be assigned to receive either Plain Aspirin and will be required to continue taking them throughout the study (three days).
15814387|NCT04330859|Other|NeoRehab Bundle|The NICU rehabilitation program includes six multimodal, GA appropriate, parent-administered interventions (vocal soothing, scent exchange, comforting touch, kangaroo care, infant massage and physical therapy)
15814388|NCT04330859|Other|Routine care|Routine NICU care including talking, touching and holding the participant per unit guideline as well as physical therapy, occupational therapy, and speech therapy per unit guideline
15814389|NCT04330846|Procedure|Surgical resection|The type of endoscopic treatment will be initially with EBD and if a failure treatment occurred then a SEMS will be placed.
15814390|NCT04330833|Other|Novel Communication Intervention|The intervention is a series of 3 guided discussions (using visual aids) between the child's primary oncology physician/nurse team and the child's parent(s) with the purpose of improving parental comprehension of the options for goals of treatment, along with the benefits and burdens of each option.
15814391|NCT04330833|Other|Enhanced Usual Care Parent Education|The Enhanced Usual Care Parent Education is a series of 3 discussions between the child's primary oncology nurse and the child's parent(s) designed to control for time and attention. These discussions are focused on answering parents' questions and reviewing routine disease and treatment related information. Parents will receive a 1-hour face-to-face session every 3-4 months for a total of 3 sessions. At each session, parents choose 2-3 topics to review with the nurse.
15814392|NCT04330820|Drug|Venetoclax Oral Tablet|This study will investigate the combination of a fixed maximum venetoclax dose with increasing cytarabine doses plus mitoxantrone in a fixed dose. The venetoclax dose of 400 mg will be reached by a ramp up over 4 days. Parallel chemotherapy with cytarabine will start on day 4.
15814393|NCT04330807|Other|Handgrip fatigability test|"Dynamometric and electromyographic assessment: patient is sitting on a chair, back upright, humerus vertically placed and forearm landing parallel to a support. Dominant arm is chosen for test and electrodes placement.
~The assessment is divided in 4 phases for a total of 30 minutes duration: Warm-up, determination of reference force settings (fast sub-maximal contractions and maximal voluntary contractions), fatigability period and rest."
15814394|NCT04330807|Other|Questionnaires|Assessment of subjective fatigue with Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) and Multidimensional Fatigue Inventory (MFI-20) questionnaires
15814395|NCT04330794|Other|NMFACT|caries index
15814396|NCT04330794|Other|DMF index|caries index chart to collect data about decayed missed filled teeth
15814397|NCT04330781|Device|Intraoral stent|Radiotherapy with intraoral stent
15814398|NCT04330781|Other|No intraoral stent|Radiotherapy without intraoral stent
15814399|NCT04330768|Procedure|PRF pulp capping|PRF is injected in the site of exposure
15814400|NCT04330768|Procedure|MTA pulp capping|conventional pulp capping procedure
15814401|NCT04330755|Drug|Saline Solution|Placebo
15814402|NCT04330755|Drug|Levosimendan|Levosimendan
15814403|NCT04330755|Drug|Magnesium Sulfate|Magnesium Sulfate
15814404|NCT04330742|Drug|lactated ringers|the intervention is one liter fluid bag of lactated ringers which is routinely used as a fluid coload for spinal anesthesia. All patients will receive the same amount of fluids however this will be paused at various time points in order to perform the echocardiogram.
15814405|NCT04330729|Drug|Acetylsalicylic acid|Se arm description
15814406|NCT04330716|Behavioral|Standard Genetic Counseling|Standard of care genetic counseling
15814407|NCT04330716|Behavioral|Educational Video|Video tutorial about genetic testing
15814408|NCT04330690|Drug|Interferon beta-1a|Interferon beta-1a containing 22 or 44 micrograms syringes will be administered subcutaneously on days 1, 3, 6.
15814409|NCT04330690|Drug|Remdesivir|Remdesivir 200mg IV on day 1, followed by 100 mg IV daily infusion for 9 days plus optimized supportive care or until discharge from hospital, whichever occurs first
15814410|NCT04330677|Drug|Oxytocin nasal spray|Intranasal administration of 24 International Units, Oxytocin will be given 30 minutes before the fear extinction task (Study 1) or fMRI measurement (Study 2).
15814411|NCT04330677|Drug|Placebo nasal spray|The placebo spray contains the identical ingredients, except for the peptide itself. It will be given 30 minutes before the fear extinction task (Study 1) or fMRI measurement (Study 2).
15814412|NCT04330677|Drug|Estrogen Gel|Participants received a single dose of estradiol gel (Estramon 2 mg estradiol, Hexal AG, Holzkirchen, Germany), applied to their shoulder, 3 hours prior to the fear extinction task (Study 1) or fMRI measurement (Study 2).
15814413|NCT04330677|Drug|Placebo Gel|Participants received a single dose of the placebo gel (ultrasonic gel, 2 mg), applied to their shoulder, 3 hours prior to the fear extinction task (Study 1) or fMRI measurement (Study 2).
15814414|NCT04330664|Drug|MRTX849|KRAS G12C Inhibitor
15814415|NCT04330664|Drug|TNO155|SHP2 Inhibitor
15814416|NCT04330651|Procedure|ECLS|Emergency application of Extracorporeal Life Support in post-surgical patients
15814417|NCT04330638|Other|Usual Care|Usual Care
15814419|NCT04330638|Drug|Siltuximab|Siltuximab will be given via single IV infusion at a dose of 11 mg/kg
15814420|NCT04330638|Drug|Tocilizumab|Tocilizumab will be given via single IV infusion at a dose of 8 mg/kg with a maximum infusion of 800 mg/injection
15814421|NCT04330625|Biological|REMD-477|REMD-477 will be administered as a subcutaneous injection for four weekly doses
15814422|NCT04330612|Other|Perioperative Updates|In the intervention group, the families received additional standardized electronic updates via pagers at three pivotal moments: 1) Initial skin incision has been made; 2) Critical part of the case is completed and closure has begun; and, 3) Closure is complete, and patient will be transferred to the recovery room when ready.
15814423|NCT04330586|Drug|Ciclesonide Metered Dose Inhaler [Alvesco]|Ciclesonide 320ug oral inhalation q12h for 14 days
15814424|NCT04330573|Other|No intervention. Observational study|Observational study
15814425|NCT04330560|Device|Fitness tracker|The participant is required to wear the fitness tracker every day during waking hours throughout the 8 weeks of intervention (except during sleeping, bathing, swimming).
15814426|NCT04330560|Device|Auto-feedback/ reminder|The participant's data link to the healthcare system which provides with auto-feedback/ reminder.
15814427|NCT04330560|Procedure|Standard care|Undergoing standard care by cardiac rehabilitation, UMMC
15814428|NCT04330547|Drug|Analgesic administration|"Level 1 : Paracétamol 1g/Acetaminophène 1g, Ibuprofène 600mg, Diclofénac 50mg.
~Level 2: Tramadol 50mg.
~Level 3: Oxycodone 5mg, Morphine sulfate 10mg.
~Increase of a prior level 3 medication :
~1/6 of the total dose of daily level 3 medication (e.g. the patient receives 30mg of oxycodone a day. He will be administered a single dose of 5 mg for the study), defined as a breakthrough dose in the management of chronic pain. To standardize the treatment, the dose of the prior level 3 medication will be converted to oxycodone. Several online tools exist to do the conversion between opioids (e.g. mobile app Orthodose ®).
~If the oral intake or the gastrostomy use is not possible, the breakthrough dose will be administered by subcutaneous route. The dose will also be 1/6 of the daily dose and will be converted to injectable morphine. Conversion to injectable morphine will be performed with any equivalence tool (such as the mobile app Orthodose ®)"
15814429|NCT04330547|Drug|Placebo administration|Folavit (folic acid, 0.4 mg)
15814430|NCT04330534|Drug|BCX9930|BCX9930 capsules for oral administration
15814431|NCT04330534|Drug|Placebo|placebo to match BCX9930 capsules for oral administration
15814432|NCT04330508|Other|Depression and Cognitive Tests|Health Related Quality of Life, neurocognitive tests, PHES
15814433|NCT04330495|Drug|Hidroxicloroquina|Chemoprophylaxis with hydroxychloroquine at a dose of 200 mg twice a day for 6 months.
15814434|NCT04330495|Drug|Control group|Testing of SARS-CoV-2 and prescription of placebo (Hydroxychloroquine placebo) twice daily for 6 months
15814435|NCT04330482|Behavioral|CARE-Well App|Participants randomized into this group will be instructed to use the CARE-Well App at least 4 times per week.
15814436|NCT04330482|Behavioral|Internet Links|Participants randomized into this group will be instructed to use a computer tablet pre-loaded with a list of internet links relevant to dementia caregiving at least 4 times per week.
15814437|NCT04330469|Procedure|Periodontal therapy|"Treatment will be performed by a periodontist.
~Intensive removal of subgingival and supragingival calculus and plaque biofilm by scaling, root-planing and polishing. The procedures will be carried out with the use of hand scalers and a piezoelectric ultrasonic scaler with universal tips. Disclosing solution will be used to visualize the plaque for the clinician.
~One to four sessions of subgingival scaling and root planing by quadrant, under local anesthesia as may be deemed necessary during the study period.
~Subgingival irrigation using an antiseptic mouth rinse (chlorhexidine 0.12%).
~Polishing of the coronal and radicular surfaces of the teeth."
15814438|NCT04330469|Procedure|Oral hygiene advice|Oral hygiene advised by Periodontist
15814439|NCT04330456|Radiation|Preoperative stereotactic radiation therapy in hypofractionation mode|"At the first step patient undergoes preoperative stereotactic radiation therapy in hypofractionation mode. Radiation therapy plan is based on topometric MRI and CT scans. Radiation therapy plan are performed after MRI and CT fusion, contouring of the target and surrounding normal tissues.
~At first step only tumor and, if necessary, the surrounding normal tissues, which will be removed during surgery, are exposed to radiation.
~GTV - determined in with the boundaries of the tumor visualised by topometric MRI and CT CTV1 - match GTV CTV2 - formed inward (to the tumor center) from GTV by 0.5-1 cm (depending on the proximity of functionally significant normal tissues (neurovascular bundles, bone tissue, skin and subcutaneous fat, etc.) PTV - 3-5 mm indent from CTV1, taking into account the proximity of functionally significant normal tissues and the planned surgery Preoperative radiation therapy is carried in 5 fractions with a single dose on PTV - 5 Gy, a single dose on CTV2 - 7 Gy."
15814440|NCT04330456|Procedure|Surgery|In 14-21 days after preoperative stereotactic radiation therapy radical surgery will be performed
15814441|NCT04330456|Radiation|Postoperative conformal radiation therapy in normofractionation mode|"In 25-35 days after the surgery postoperative conformal radiation therapy is performed according to the standard protocol GTV (tumor bed) - based on the volume of the primary tumor, including the swelling zone (T2-weighted images on preoperative MRI) СTV - formed with an indent of 4 cm from GTV (without going beyond the boundaries of the involved compartment), in the transverse direction the indent could be reduced to 2 cm.
~PTV - formed with an indent of 0.5-1cm from CTV An important condition for planning radiation therapy is to limit the dose absorbed during both stages of radiation therapy in surrounding normal tissues that are not removed during surgery."
15814442|NCT04330443|Procedure|Surfactant therapy|To study if lung ultrasound allows an earlier surfactant therapy (within the first 2 hours of life) compare to FiO2 and Chest X Ray
15814443|NCT04330430|Drug|T-VEC|The treatment schedule is based on 4 courses of intralesional T-VEC and 3 courses of intraveneous Nivolumab. T-VEC first, in order to achieve the best synergistic effect with influx of CD8+ T-cells prior to the first Nivolumab dose. T-VEC monotherapy with the dose 10^8 PFU/mL is given every 2 weeks after 3 weeks of the first T-VEC dose (with the first dose of T-VEC 10^6 PFU/mL to allow for seroconversion), and Nivolumab will be given every 2 weeks.
15814444|NCT04330417|Device|Robot-Assisted Hand Training|Perform activities of daily living, e.g., write sentences, turn cards, move small and big objects, simulated feeding, stack checkers, pour water, squeeze handles
15814445|NCT04330417|Other|Standard Hand Therapy|Stretching, Strengthening, Hand Functional Training
15814478|NCT04330183|Drug|Normal Saline|3cc of normal saline
15814479|NCT04330144|Drug|Hydroxychloroquine as post exposure prophylaxis|1day: Hydroxychloroquine 800mg Qd po 2-5dy: Hydroxychloroquine 400mg Qd po
15814446|NCT04330404|Behavioral|Cognitive strategy training|The Cognitive strategy training, including awareness enhancement, cognitive-related education, discussion of everyday cognitive difficulties, generation of cognitive strategies, cognitive strategy practice, and homework assignments
15814447|NCT04330404|Behavioral|group interactive game|The active control group will receive group interactive game, including table games and games using songs, balloons, newspapers and so on.
15814448|NCT04330391|Behavioral|Remote dietitian supervised weight loss intervention and mobile app|Please see intervention arm description for more details.
15814449|NCT04330378|Other|Hospital-at-home|As per experimental arm
15814450|NCT04330378|Other|Usual in-hospital care|As per control arm
15814451|NCT04330365|Behavioral|Whole Health Team (WHT) Intervention Arm, Primary Care Group Education (PC-GE) Intervention Arm, Usual Primary Care (UPC) Arm|Participants will be randomly assigned at the individual level to either WHT, PC-GE or Usual Primary Care, stratified by site, sex, and use of prescribed opioids for chronic pain. The follow-up period for the three arms will be 12 months. The primary outcome is change in pain interference. Secondary outcomes include change in pain intensity, functioning, quality of life, changes in use of pain medications, including opioids (if applicable) and changes in nonpharmacological pain self-management activities. After the baseline assessment, masked telephone assessments will be administered to participants at 3, 6, 9, and 12 months.
15814452|NCT04330352|Behavioral|"Mindfulness-based STOP touching your face practice"|1. Remind yourself to STOP. Whatever you are doing in this moment (e.g. touching your month, pinching your nose, rubbing your eyes, resting your chin on your hands), pause for a minute. 2. Take a deep breath. This reconnects you with your body. Pay attention to your breathing and just allow yourself to continue to breathe normally and naturally. 3. Observe what is happening for you in this moment-including thoughts, feelings, and emotions (e.g. feel distracted, anxious or nervous?). What do you notice in your body (e.g. feel itchy or tingling on any part of your face)? You can be aware of anything: posture, sensations, tension in your body, or, once again, your breath. You might notice the sound around you. You might even notice your thoughts or emotions. 4. Proceed with whatever you were doing before you came to a STOP or something that you want to do in the moment (e.g. proceed with touching your face, or stop face-touching and take an alternative behavior).
15814453|NCT04330339|Behavioral|Fasting|Fasting
15814454|NCT04330326|Drug|Metabolic Cofactor Supplementation|Subjects in active treatment will receive dietary supplementation with N-acetylcysteine, L-carnitine tartrate, nicotinamide riboside, and serine, administered as a mixture. Half dosage of the co-factors will be given for two weeks (one dose taken just after dinner), and full dosage for 8 weeks (two equal doses taken just after breakfast and dinner).
15814455|NCT04330326|Drug|Sorbitol|As placebo, sorbitol (5 g) flavored with strawberry aroma and coloring agent will be given. Sorbitol is widely used due to its solubility in water. It's approved by the U.S. Food and Drug Administration (FDA).
15814456|NCT04330313|Procedure|Traction|Intermittent traction will be applied to the cervical region in a supine position with the neck at 25-30 ° flexion. The target weight is determined as 10% of the patient's weight. Traction pulling force applied to the target weight will be achieved gradually increasing from low. Traction therapy will be applied intermittent traction for 15 minutes in each session as 60 seconds retention and 60 seconds rest. The therapy will be held for 18 sessions, 3 days / week.
15814457|NCT04330313|Procedure|Laser therapy|Laser therapy will be applied to the participants with a GaAs laser with 904 nm wavelength, 6 points transforaminally, 120 seconds to each point, at 2 J / cm² density, total dose of 12 J laser therapy by keeping the probe in constant contact with the skin.
15814458|NCT04330313|Procedure|Hot pack|The hot pack, which is the superficial heat agent, will be held in the neck area of the participants for 20 minutes in each session.The therapy will be held for 18 sessions, 3 days / week.
15814459|NCT04330313|Procedure|Stretching|Stretching exercises will be repeated 3 times a day in total, 2 times a day self-stretching at home and 1 time under the supervision of a physiotherapist. Exercises for upper trapezius muscle, sternokleudomasteudeus (SCM) muscle and the scalene muscle to be applied in a 3 repeat by waiting 30 seconds, stretching under tension.The therapy will be held for 18 sessions, 3 days / week.
15814460|NCT04330300|Drug|Thiazide or Thiazide-like diuretics|Anti-hypertensive (Active Arm)
15814461|NCT04330300|Drug|Calcium Channel Blockers|Anti-hypertensive (Active Arm)
15814462|NCT04330300|Drug|ACE inhibitor|Anti-hypertensive (Control Arm)
15814463|NCT04330300|Drug|Angiotensin receptor blocker|Anti-hypertensive (Control Arm)
15814464|NCT04330274|Other|Bipedal with open eyes|Standing bipedal with open eyes on force platform
15814465|NCT04330274|Other|Bipedal with closed eyes|Standing bipedal with closed eyes on force platform
15814466|NCT04330274|Other|Bipedal with open eyes and with platform|Standing bipedal with open eyes and with platform under heel of prosthetic foot on force platform
15814467|NCT04330274|Other|Bipedal with closed eyes and with platform|Standing bipedal with closed eyes and with platform under heel of prosthetic foot on force platform
15814468|NCT04330261|Other|Exposure (not intervention) - SARS-CoV-2 infection|Exposure is infection with the virus. There is no intervention
15814469|NCT04330248|Drug|Erdafitinib|Participants receive single oral dose of erdafitinib from Day 1 to 15 in Period 1 and 2.
15814470|NCT04330248|Drug|Rifampin|Participants will receive rifampin from Day 15 to 28 in Period 2.
15814471|NCT04330235|Other|Healthy Default Kids' Beverage Policy|The healthy default kids' beverage policy requires that all restaurants serve only healthy beverages (water, milk, or 100% juice) instead of sugary beverages as the default beverage with children's meals. The policy has been enacted in New York City and Philadelphia and will go into effect in April 2020.
15814472|NCT04330222|Diagnostic Test|7 Tesla Magnetic Resonance Imaging|Diagnostic Imaging
15814473|NCT04330222|Other|Brief Memory and Executive Test|Cognitive Assessment
15814474|NCT04330209|Other|weight loss diets|The ketogenic diet group were instructed to consume <35g of carbohydrates per day, and <10% of total calories were from saturated fats. Daily protein intake was set at 1.2g/kg bodyweight for females, and 1.5g/kg bodyweight for males. The low-GI nutrigenetic diet group had individualised dietary instructions based on their genetic results
15814475|NCT04330196|Diagnostic Test|Oral glucose tolerance test|Participant ingests 75g of glucose
15814476|NCT04330196|Diagnostic Test|Ingestion of placebo|Participant ingests 700mg of aspartame
15814477|NCT04330183|Drug|Ketamine|0.3mg/kg of ketamine
15814481|NCT04330131|Behavioral|3Ts - Newborn|A video shared with parents/caregivers during a universal screening in hospital mother-baby units. This intervention shares the importance of early talk and interaction with a child to support their early brain development as well as strategies for parents to do so.
15814482|NCT04330131|Behavioral|3Ts - Well Baby|Four videos shared during well child immunization visits at 1-, 2-, 4-, and 6-months in pediatrician offices. This intervention shares the importance of early talk and interaction with a child to support their early brain development as well as strategies for parents to do so.
15814483|NCT04330131|Behavioral|3Ts - Let's Talk!|A series of eight group classes involving education, feedback, and goal setting for parents/caregivers of children age one through three, delivered in a community-based organization. This intervention shares the importance of early talk and interaction with a child to support their early brain development as well as strategies for parents to do so.
15814484|NCT04330105|Device|ECG, HolterECG ,Echocardiography|ECG, HolterECG ,Echocardiography to determine any type of arrythmia,ischaemic heart disease,valvular heart disease,systolic and diastolic dysfunction
15814485|NCT04330079|Drug|Dapagliflozin 10mg|Dapagliflozin 10mg once daily for 6 months.
15814486|NCT04330079|Other|Lifestyle modification|lifestyle modification (diet and exercise) for 6 months
15814487|NCT04330066|Diagnostic Test|Abdominal ultrasound measurement of the endometrial lining|On the day of the participants frozen embryo transfer, an endometrial thickness measurement (T2) will obtained from an abdominal ultrasound during the embryo transfer.
15814488|NCT04330053|Other|Experimental|"Training will address issues such as: environmental security, identifying hazards that can lead to a fall, psychological support, getting up from a fall, standing techniques and calling for help.
~The exercise program will last for six months and will be based on the OTAGO exercise program, which includes five exercise groups: general warm-up, muscle strengthening exercises, balance exercises, range of motion and stretching exercises. The program will be performed individually or in groups of two people at most and will be conducted once a week in one of the 5 outpatient clinics under the supervision of a specialized OTAGO trainer, while seniors should repeat the exercises twice a week alone at home and also walk twice a week for at least half an hour."
15814489|NCT04330053|Other|Control|"Information / Education about falls The participants in this group will receive the same information - education as the participants of the 1st group.
~They will be given a leaflet with general gentle exercises (not fall prevention specific) for the home."
15814491|NCT04330027|Biological|Growth factors|A new patented product named lyophilized Growth Factors that is an advanced and refined form of conventional platelet-rich plasma
15814492|NCT04330027|Other|Saline|0.9% Sodium Chloride
15814493|NCT04330014|Behavioral|vaccine|affect vaccination on children
15814494|NCT04329988|Other|questionnaire|A questionnaire will be made available to all eligible patients in general practitioners waiting rooms. This questionnaire will be composed by the single question, followed by the AUDIT and FACE questionnaires, and three socio-demographic questions. This questionnaire will be anonymous. Patients who agree to fill out a questionnaire will place it in a sealed box once completed.
15814495|NCT04329975|Drug|Desmopressin|Desmopressin (MINIRINMELT OD tablet) 25μg or 50μg, orally.
15814496|NCT04329962|Other|Blueberry Powder Food Product|Consume blueberry powder confection
15814497|NCT04329962|Other|Dietary Intervention|Consume blueberry extract confection
15814498|NCT04329962|Other|Questionnaire Administration|Ancillary studies
15814499|NCT04329949|Drug|Relacorilant, 100 mg and 25 mg|Relacorilant is supplied as capsules for oral dosing.
15814500|NCT04329949|Drug|Nab paclitaxel|Nab-paclitaxel is administered as IV infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle.
15814501|NCT04329936|Behavioral|Retention center Geispolsheim population|All recently held individuals in the retention center can be included in the study after signing the information and consent protocol.
15814502|NCT04329923|Drug|Hydroxychloroquine Sulfate 400 mg twice a day|Antimalarial compound
15814503|NCT04329923|Drug|Hydroxychloroquine Sulfate 600 mg twice a day|Antimalarial compound
15814504|NCT04329923|Drug|Hydroxychloroquine Sulfate 600 mg once a day|Antimalarial compound
15814505|NCT04329923|Drug|Placebo oral tablet|Placebo
15814506|NCT04329910|Other|no intervention|no intervention - observational only
15814507|NCT04329897|Behavioral|Software Messaging|Acceptance and Commitment Therapy Delivered via an Automated Mobile Messaging Robot Mobile messages utilizing the principles of Acceptance and Commitment therapy. These messages were developed in collaboration with a pain psychologist who specializes in treating chronic pain with Acceptance and Commitment therapy. Subjects received twice-daily messages for two weeks following their orthopaedic procedure.
15814508|NCT04329884|Procedure|Cooled RFA treatment with COOLIEF* device|Patients who are randomized to receive CRFA will be given the treatment by a specialist into the affected hip with OA, and the patient will be followed to determine amount of pain relief and improved hip joint function.
15814509|NCT04329884|Drug|intra-articular corticosteroid injection|Patients who are randomized to receive intra-articular corticosteroid injections will be given the treatment by a specialist into the affected hip with OA, and the patient will be followed to determine amount of pain relief and improved hip joint function.
15814510|NCT04329858|Procedure|silver modified glass ionomer|occlusal cavity filled with silver modified
15814511|NCT04329858|Procedure|zinc modified|occlusal cavity filled with zinc modified
15814512|NCT04329858|Procedure|conventional glass ionomer|occlusal cavity filled with conventional glass ionomer
15814513|NCT04329845|Procedure|open splenectomy|open splenectomy for treatment of splenic injury
15814514|NCT04329845|Procedure|laparoscopic splenectomy for splenic injury in trauma|laparoscopy as a technique for removal of the spleen in injury
15814515|NCT04329832|Drug|Hydroxychloroquine|Patients in the hydroxychloroquine arm will receive hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 4 days (dose reductions for weight < 45 kg or GFR (glomerular filtration rate)<50ml/min). For patients < 45kg, doses will be halved. For patients with GFR<50ml/min, the final dose of hydroxychloroquine will not be administered. If the patient has already received hydroxychloroquine prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.
15814704|NCT04328194|Diagnostic Test|Cancer Antigen 15-3 (CA15-3).|will be done for the 2 groups
15814516|NCT04329832|Drug|Azithromycin|Patients in the azithromycin arm will receive azithromycin 500 mg on day 1 plus 250 mg daily on days 2-5 (may be administered intravenously per clinician preference). If the patient has already received azithromycin prior to randomization (no more than 2 days), the prior doses will count toward the 5-day total.
15814517|NCT04329806|Drug|Moxonidine 0.2 MG|Moxonidine 0.2 MG twice daily
15814518|NCT04329806|Drug|Amlodipine 5 MG|Amlodipine 5 MG twice daily
15814519|NCT04329793|Device|Assisted gait training with Walkbot System|The experimental group will receive at least 3 treatment sessions per week consisting of 40 minutes in robot-assisted gait training with Walkbot System in addition to their usual Physical therapy sessions. In total, the number of Walkbot sessions will be 20, in uninterrupted weeks.
15814520|NCT04329793|Other|Physical Therapy|The control group will receive their usual Physical therapy sessions during 6 weeks.
15814521|NCT04329767|Device|IRIS 1.0|Intuitive's IRIS 1.0 system is a software only device and service intended to create and deliver segmented image studies (3D anatomical models) based on patients computed tomography (CT) scans. It is intended as software for preoperative surgical planning, and as software for the intraoperative display of the aforementioned multidimensional digital images.
15814522|NCT04329754|Device|Cataract surgery|Cataract surgery with implantation of an intraocular lens (IOL)
15814523|NCT04329741|Behavioral|6-week basic dog obedience training course|The class focused on teaching owners how to better communicate with their dog and covered basic commands (e.g., sit, down, watch), loose leash walking, and polite greetings, among other skills. The importance of dog walking was implied, but not specifically emphasized. Classes were held once per week for 45 minutes, with 5-8 students per class.
15814524|NCT04329728|Drug|AVM0703|Intravenous infusion over ~1 hours
15814525|NCT04329715|Behavioral|Expedited postoperative activity instructions|Ad lib postoperative activity and return to work recommendations
15814526|NCT04329715|Behavioral|Standard postoperative activity restructions|Standard conservative postoperative activity and return to work recommendations
15814529|NCT04329689|Other|The Septal myectom|"The Septal myectomy is the preferred treatment of most patients with HOCM, and many studies have documented relief of symptoms and satisfactory late patient survival after relief of outflow tract gradients.
~valve repair or replacement may be necessary"
15814530|NCT04329676|Procedure|Deep Brain Stimulation|Patients with PD who are eligible to bilateral STN DBS surgery and chose to get directSTIM System implanted will be followed over a 6-month period to evaluate changes in their condition.
15814531|NCT04329663|Device|Indonesian computer-based game prototype|In order to improve the ADHD clinical symptoms and executive function of the player, this game should has challenge similar to memory game which is the player was given object to be memorized and then match the object in accordance to the task given inside the game. With some difficulty leves, this game was tried to trigger players in terms of accuracy and quickness in completing the mission.
15814532|NCT04329650|Drug|Siltuximab|A single-dose of 11mg/Kg of siltuximab will be administered by intravenous infusion.
15814533|NCT04329650|Drug|Methylprednisolone|"A dose of 250mg/24 hours of methylprednisolone during 3 days followed by 30mg/24 hours during 3 days will be administered by intravenous infusion.
~If the patient is taken lopinavir/ritonavir, the dose will be 125 mg/ 24 hours during 3 days followed by 15mg/24 hours during 3 days."
15814534|NCT04329637|Other|Integrative healt care|Meditation and use of a care cordinator
15814535|NCT04329624|Drug|Levosimendan|Levosimendan 2.5 mg/ml injection contains levosimendan 2.5 mg, povidone 10.0 mg, citric acid, anhydrous 2.0 mg and ethanol, anhydrous to 1.0 mL. Levosimendan injection is a clear, yellow to orange solution. Immediately after skin incision patients allocated to the verum group will receive a dose of 12.5 mg in 500 mL of levosimendan.
15814536|NCT04329624|Drug|Placebo|"Placebo 2.5 mg/ml injection contains riboflavine sodium phosphate 0.4 mg, dehydrated alcohol 100 mg and water for injection to 1 mL.
~Immediately after skin incision patients allocated to the placebo group will receive 500 mL of 5% Glucose."
15814537|NCT04329611|Drug|Hydroxychloroquine|COVID19
15814538|NCT04329598|Other|Whole-Body Electromyostimulation Group|Whole-Body Electromyostimulation group includes exercises with electric stimulation. Whole-Body Electromyostimulation group will have 45 minutes of exercises which are specific exercises for Lumbar Disc Herniation.
15814539|NCT04329598|Other|Exercise Group|Exercise group includes exercises without electric stimulation. Exercise group will have 45 minutes of exercises which are specific exercises for Lumbar Disc Herniation.
15814540|NCT04329585|Drug|flumazenil|EEG is observed in both groups to compare the difference between two groups.
15814541|NCT04329585|Drug|Placebos|Placebo is the normal saline, which is given in the controlled group.
15814542|NCT04329572|Drug|Hydroxychloroquine Sulfate|All patients included in the study will receive HCQ (400 mg BID on D1 and 400 mg/day on D2 to D5) for 5 days.
15814543|NCT04329572|Drug|Azithromycin Tablets|All patients included in the study will receive AZT 500 mg per day for 5 days.
15814544|NCT04329546|Other|NA (no intervention)|NA (no intervention)
15814545|NCT04329533|Other|"Calm is a mindfulness meditation mobile app"|"Mindfulness meditation is a self-management strategy that can be utilized to assist with the management of stress. Mindfulness meditation mobile applications, such as the Calm app, can be used to help manage stress, especially during this uncertain time."
15814546|NCT04329507|Diagnostic Test|Breath test|collection of an exhaled breath sample
15814547|NCT04329494|Drug|Cisplatin|Given via PIPAC
15814556|NCT04329481|Dietary Supplement|Mycodigest supplement|"Mycodigest is a dietary supplement which consists of traditional medicinal mushrooms, as essences and grounded powder"
15814557|NCT04329468|Device|DS-MCE|"The subjects swallowed the MCE to investigate the esophagus repeatedly by pulling up or down the string. After completion of the esophageal examination, MCE reached the stomach and was lifted away from the posterior wall, rotated if necessary and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. After finishing the stomach examination, the capsule would enter the duodenum due to peristalsis when the pylorus opened. Then DS-MCE tried to inspect the duodenum repeatedly under the string and magnetic field control, including view of major papilla in the descending part of duodenum and retrograde view of pylorus in duodenal bulb with a 360-degree automatic scanning mode. After completion of the duodenum examination, the capsule started to view the small bowel."
15814558|NCT04329455|Procedure|Endoscopic thyroidectomy|Endoscopic thyroidectomy in Thyroid Nodules
15814559|NCT04329442|Drug|Emtricitabine / Tenofovir Disoproxil Oral Tablet|30 day supply of 200mg tablets
15814560|NCT04329429|Drug|RC48-ADC|The eligible patients will be treated with RC48-ADC, an antibody-drug conjugate, 2.5 mg/kg, once every two weeks until investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first)
15814561|NCT04329416|Other|Predicted depth of insertion|A left-sided double-lumen tube was introduced beyond the vocal cords when the train-of-four stimulation of the ulnar nerve revealed 1 or 2 twitches, the stylet was removed, the double-lumen tube was rotated 90° counterclockwise and then advanced blindly to the predicted depth of insertion.
15814562|NCT04329416|Other|Optimized depth of insertion|The optimal position of the double-lumen tube, defined as the inflated endobronchial cuff is placed in the left main bronchus just below the carina without herniation, which was confirmed using a flexible bronchoscope in both supine and lateral decubitus positions.
15814563|NCT04329416|Other|Adjustment of depth of insertion|If the endobronchial cuff was placed too deeply or too proximal, subsequently, the double-lumen tube was withdrawn or advanced, respectively, using the flexible bronchoscope until the optimum position of the double-lumen tube was achieved.
15814564|NCT04329403|Drug|Adapalene 0.1% Gel|A thin film of the assigned medication to be applied once daily in the evening for 12 weeks
15814565|NCT04329403|Drug|Differin 0.1% Topical Gel|A thin film of the assigned medication to be applied once daily in the evening for 12 weeks
15814566|NCT04329403|Other|Placebo|A thin film of the assigned medication to be applied once daily in the evening for 12 weeks
15814567|NCT04329390|Drug|Anticoagulant drugs|Prescription of, or already on oral anticoagulant treatment.
15814568|NCT04329377|Diagnostic Test|blood test|complete blood count and platelet function
15814569|NCT04329364|Combination Product|Laser Haemorrhoidoplasty (LAH)|Using a laser diode to cause coagulative necrosis to the haemorrhoidal cushion
15814570|NCT04329364|Procedure|Open milligan-morgan conventional haemorrhoidectomy|conventional excisional haemorrhoidectomy
15814571|NCT04329351|Procedure|Guided Bone regeneration|Guided bone regeneration to ridge preservation
15814572|NCT04329338|Other|Lactobacillus pentosus KCA1|Lactobacillus pentosus KCA1 suspended in dairy and taken orally for 14 days
15814573|NCT04329325|Biological|Blinatumomab|Please see detailed summary.
15814574|NCT04329325|Drug|dasatinib|Please see detailed summary.
15814575|NCT04329325|Drug|dexamethasone|Please see detailed summary.
15814576|NCT04329325|Drug|methotrexate|Please see detailed summary.
15814577|NCT04329312|Radiation|Thoracic computed tomography|Patients undergo contrast-enhanced thoracic computed tomography as part of their routine clinical work up.
15814578|NCT04329299|Diagnostic Test|blood-based biomarkers analyses|Analyses of H. pylori antibodies/pepsinogen levels, micro RNAs (miRNAs) or blood-based protein markers levels in participants' blood samples
15814579|NCT04329273|Other|Sliding leg curl|The exercise protocol consists of the following sets and repetitions Week 1- 2 sessions with 2 sets of 6 repetitions Week 2- 2 sessions with 3 sets of 6 repetitions Week 3- 2 sessions with 4 sets of 6 repetitions Week 4- 2 sessions with 4 sets of 8 repetitions Week 5- 2 sessions with 4 sets of 10 repetitions Week 6- 2 sessions with 4 sets of 10 repetitions Week 7- 2 sessions with 4 sets of 8 repetitions Week 8- 2 sessions with 4 sets of 8 repetitions
15814580|NCT04329273|Other|Balance training|"The exercise protocol consists of 2 sessions/week with 4 sets of 30'' single stance.
~Week 1 and 2- 1 set of 30'' single leg stance and 3 sets of 30'' single leg stance and ball kicks with contralateral foot Week 3 and 4- 2 sets of 30'' single leg stance while moving the ball around the leg with the contralateral foot and 2 sets of 30'' single leg stance, moving a ball around the knee with hands and kicking a ball with contralateral foot Week 5 and 6- 2 sets of 30'' single leg stance while giving and receiving hand passes with medicine ball (in couples) and 2 sets of 30'' single leg stance with perturbations (in couples) Week 7 and 8- Same as week 5 and 6 with extra 15 in each repetition"
15814581|NCT04329273|Other|Core stability|"The exercise protocol consists of the following sets and repetitions Week 1 and 2- 3 sets of 30'' front plank, 3 sets of 20'' side plank, 2 sets of 30'' superman, 2 sets of 30'' supine bridge and 2 sets of 10 repetitions leg lowering exercise Week 3 and 4- increasing difficulty in 2 of the sets Week 5 and 6- adding 1 more set at each exercise Week 7 and 8- adding 15 in each repetition"
15814582|NCT04329247|Other|Median nerve neural mobilization|Manual therapy maneuver performed in the upper limb.
15814583|NCT04329221|Drug|Calcipotriol Only Product in Cutaneous Dose Form|Calcipotriol (Calcipotriene) is a form of vitamin D. It works by inducing thymic stromal lymphopoietin cytokine expression in the skin.
15814584|NCT04329221|Drug|Vaseline|Placebo
15814585|NCT04329221|Drug|Topical 5FU|5-FU is a chemotherapy that causes the death of proliferating tumor cells. Topical preparation of this drug is being used.
15814586|NCT04329208|Device|Transcranial doppler|"TCD examination was performed using DWL-EZ-Dop machine Compumedics GmbH, Singen, Germany. TCD utilizes low-frequency pulsed insonation (2 MHz) to measure blood flow velocity within proximal cerebral arteries, obtaining systolic and diastolic peaks and mean flow velocities (MFV). MFV is defined as (systolic + diastolic)/3 + diastolic velocities, according to Alexandrov et al..
~Initial TCD examination was done after admission serving as a baseline state for cerebral circulation. Follow-up TCD examinations was done at fixed intervals on the first, third, fifth, seventh and tenth days of the onset of SAH."
15814587|NCT04329195|Drug|1: discontinuation of RAS blocker therapy|discontinuation of RAS blocker therapy
15814589|NCT04329169|Other|Virtual Implant Planning|According to the virtual implant plan, a CAD/CAM tooth supported surgical guide will be fabricated to place the dental implant with a fully guided surgical protocol.The surgical guide will be manufactured from a photopolymer resin using a 3D printing machine. A hex- shaped metal sleeve will be inserted in the surgical guide with the flat surface located buccally so that it will help in orientation of the implant hex during the implant placement.
15814590|NCT04329156|Other|Digitally Flip Technique|A prefabricated shell will be made then after implant placement, the shell will be attached to a plastic abutment using flowable composite to make a customized healing abutment.
15814591|NCT04329156|Other|Stock Healing Abutment|After implant placement, a stock healing abutment will be placed onto the implant and screwed on. It will be selected to be 1-2 mm above the gingival margin and slightly smaller in diameter than the intended final restoration.
15814592|NCT04329143|Procedure|open completion cholecystectomy|open excision of cystic duct remnant
15814593|NCT04329143|Procedure|lap completion cholecystectomy|lap excision of cystic duct stone
15814594|NCT04329130|Drug|Chidamide, Lenalidomide|All patients enrolled in the study will accept Chidamide combination with lenalidomide regimen.
15814595|NCT04329104|Biological|VRC-MALMAB0100-00-AB (CIS43LS)|Administered via one-time IV infusion
15814596|NCT04329104|Other|Normal saline|Administered via one-time IV infusion
15814597|NCT04329091|Drug|Dexmedetomidine|All subjects will receive Dexmedetomidine to induce sedation between their pre-sedation and post-sedation perceptual learning tests.
15814598|NCT04329065|Biological|pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine|Given ID
15814599|NCT04329065|Drug|Paclitaxel|Given via infusion
15814600|NCT04329065|Biological|Trastuzumab|Given IV
15814601|NCT04329065|Biological|Pertuzumab|Given IV
15814602|NCT04329052|Behavioral|Adventure-based training with health educational talk|Participants need to attend an adventure-based training with various experiential learning activities with a health educational talk on mental health.
15814603|NCT04329039|Drug|Somatostatin analog|Somatostatin analog plus perioperative antibiotics Placebo plus perioperative antibiotics
15814604|NCT04329026|Device|Smart glasses|The real-time ultrasound image is displayed through head-mounted display Moverio BT-300 (Epson Inc., USA) during the radial arterial cannulation.
15814605|NCT04329026|Device|Control|The real-time ultrasound image is displayed by the ultrasound machine's monitor during the radial arterial cannulation.
15814606|NCT04329013|Other|Left lateral Position during intervention|Left lateral position during EGD
15814607|NCT04329013|Other|Prone Position during intervention|Prone position during EGD
15814608|NCT04329000|Drug|Esomeprazole 40mg|On-demand Esomeprazole 40 mg QD
15814609|NCT04329000|Drug|Esomeprazole|Continuous Esomeprazole 40 mg QD
15814610|NCT04328987|Procedure|cold snare polypectomy|Resection of colorectal polyp using cold snare polypectomy method. The polyp will be resected by mechanical force of snare without electrical cautery.
15814611|NCT04328974|Procedure|lumbar CSF drainage|We have performed the lumbar CSF drainage on the level of the lumbar spine between L3 and L4 with the patient lying in the lateral decubitus position with hips and knees flexed. A lumbar drainage catheter was inserted using a HermeticTM lumbar accessory kit (Integra Neurosciences, Plainsboro, NJ, USA) in the patients. ICP monitoring via lumbar drainage catheter was practiced using the LiquoGuard® (Möller Medical GmbH & Co KG, Fulda, Germany). ICP control strategies was initiated when ICP exceeded 15 mmHg in the absence of noxious stimuli at the rate of 10~20 ml/h via a lumbar drainage catheter until ICP was less than 15 mmHg [14, 15].
15814612|NCT04328961|Drug|Hydroxychloroquine Sulfate|Eligible participants in a household randomized to this study arm will receive hydrochloroquine therapy
15814613|NCT04328961|Drug|Ascorbic Acid|Eligible participants in a household randomized to this study arm will receive ascorbic acid therapy.
15814614|NCT04328948|Radiation|Chemoradiotherapy|Chemoradiotherapy
15814615|NCT04328935|Behavioral|WET|The manual is based on established CBT interventions in trauma such as exposure. In short, the treatment is that the participant should be able to approach their intrusive memories and by doing this repeatedly, the memory will give rise to less discomfort.
15814616|NCT04328922|Other|Fecal microbial transplantation|Capsules of fecal matter solution (feces from healthy donor, glycerol and saline solution)/
15814617|NCT04328922|Other|Placebo capsuls|capsules of glycerol and saline (placebo).
15814618|NCT04328909|Device|E-Care|Parent-centered care software application (e-Care) to ensure parents of febrile infants are optimally informed and participate in shared decision making in the ED
15814619|NCT04328909|Other|Control Group|Usual care - No E-Care app will be provided
15814620|NCT04328896|Other|CGM-Tele-monitoring|"Baseline Visit-Visit 0
~Obtain informed consent
~Administer questionnaires
~Measure A1C
~Start study Dexcom CGM device (those already on CGM will change to the study device).
~The patient will be signed into Tidepool using a research code name and email.
~Visit 1-2 weeks
~14 days worth of data will be downloaded from the patient's CGM device.
~Systems will be checked to be sure they are functioning
~Remote monitoring program will be activated.
~Telemedicine procedure will be discussed with patient; emergency contact numbers will be obtained in case patient cannot be reached
~Visit 2-14 weeks
~Administer questionnaires
~Measure A1C.
~Collect CGM data and compare to baseline
~Testing and Assessments:
~Continuous glucose monitoring
~Tidepool cloud upload
~HbA1c
~T1D REDEEM diabetes distress questionnaire
~Hypoglycemia Fear Survey
~Assessment of Severe Hypoglycemia and Diabetic Ketoacidosis"
15814621|NCT04328883|Drug|Aspirin|Oral and inhaled ASA formulations
15814622|NCT04328870|Other|oxytocin and spinal anesthesia|start oxytocin 10 IU/200 ml saline at the insertion of the spinal anesthesia
15814623|NCT04328870|Other|General anesthsia|General anesthesia alone.
15814624|NCT04328857|Device|pseudoelastic orthosis|The subject will be given specific physiotherapy including activities oriented to multimodal exploration and refinement of gross and fine motor skills, customized according to the functional status of the individual patient.
15814625|NCT04328844|Drug|IOA-244|IOA-244 will be administered orally once daily (QD)
15814626|NCT04328831|Biological|IBI322|Recombinant anti-human CD47/PD-L1 bispecific antibody injection
15814627|NCT04328818|Diagnostic Test|indwelling device biofilm identification|performance of the NGS-based identification technique in comparison with the conventional culture-based one, for the same indwelling device biofilm sample
15814629|NCT04328779|Other|The multi-task overground walking training|The multi-task overground walking training group will undertake overground walking training while concurrently perform motor and cognitive tasks for 30 minutes per session, 3 times a week for 4 weeks.
15814630|NCT04328779|Device|The multi-task treadmill walking training|The multi-task treadmill walking training group will train the same set of motor and cognitive tasks while walking on the treadmill for 30 minutes per session, 3 times a week for 4 weeks.
15814631|NCT04328779|Other|Traditional rehabilitation|Traditional rehabilitation will train strength, balance, and gait for 30 minutes per session, 3 times a week for 4 weeks.
15814632|NCT04328766|Drug|DWC202005, alone|DWC202005, as a single dose
15814633|NCT04328766|Drug|DWP14012 + DWC202005|DWP14012 and DWC202005, as a single dose
15814634|NCT04328766|Drug|DWP14012 + DWC202005, after multiple doses of DWP14012|DWP14012 and DWC202005, after multiple oral doses of DWP14012 once daily for 12 days
15814635|NCT04328753|Drug|Super Oxide water|Microsafe®, a recently available super-oxidized solution for gingival care, offers a completely improved approach for treatment of gingivitis. The neutral pH, super oxidized water was certified as an antiseptic .
15814636|NCT04328753|Drug|Chlorhexidine mouthwash|CHX is a regular bisbiguanide artificial antiseptic containing of two biguanide groups and four chlorophenyl rings linked by a hexamethylene bridge. The dicationic nature of CHX makes it interacting strongly with anions, which is related to its safety, efficacy, and side effects. It is available in three forms, digluconate, acetate and hydrochloride salts. CHX has broad spectrum antimicrobial activity
15814637|NCT04328753|Other|Distilled water|act as a negative control in this study
15814638|NCT04328740|Drug|TP-1454 monotherapy|Flat dose once or twice daily, alone
15814639|NCT04328740|Drug|TP-1454 combination therapy|Flat dose once or twice daily, in combination with ipilimumab and nivolumab
15814640|NCT04328727|Drug|eltrombopag|Tablet 25mg and 12.5mg
15814641|NCT04328727|Drug|rabbit anti-thymocyte globulin (r-ATG)|r-ATG 25 mg sterile lyophilized powder in 10 mL vials for IV use
15814642|NCT04328727|Drug|cyclosporine A (CsA)|CsA 25mg Capsule or CsA 5.0g/50mL solution for oral use
15814643|NCT04328714|Drug|Interferon gamma (IFNγ)-primed human bone marrow-derived mesenchymal stromal cells|"To determine the maximal dose, initially adult subjects will receive a single infusion of third party, freshly ex vivo expanded, IFNγ-primed MSCs at a dose of 2 x 106 cells/kg of ideal body weight on Day +1 (the day after infusion of the hematopoietic cell graft). The dose will be escalated to 5 x 106 and then 10 x 106 cells/kg. In absence of any dose limiting toxicity, 10 x 106 cells/kg will be accepted as the maximal dose.
~Subsequent participants in the adult and pediatric cohorts will receive the maximal dose as determined by the initial adult participants.
~Participants will receive the infusion in an inpatient setting. MSCs will be intravenously infused through a central line or a large bore peripheral IV using standard blood product tubing within 4 hours of release. The product will be infused by IV push or syringe pump over 5 -15 minutes."
15814644|NCT04328701|Behavioral|Mindfulness-based Cognitive Behavioral Therapy|Mindfulness-based CBT methods are based on pain self-management paradigms, and involve the identification and reduction of maladaptive pain-related cognitions (i.e., catastrophizing), the enhancement of self-efficacy for managing pain, and training in the use of adaptive pain-coping strategies such as relaxation, distraction, and self-talk.
15814645|NCT04328636|Drug|Nebulized Magnesium Sulfate|Nebulized magnesium sulfate (isotonic solution) 256 mg every 15 minutes
15814646|NCT04328636|Drug|Intravenous Magnesium Sulfate|Intravenous magnesium sulfate 200 mg/kg over 30 minutes, followed by a continuous infusion at a rate of 50 mg/kg/hour
15814647|NCT04328623|Procedure|Hypnosis|"conversational hypnosis technique call the magic glove"
15814648|NCT04328623|Procedure|Infiltration|Ultrasound-guided hand infiltration
15814649|NCT04328610|Procedure|LYMPHA(LYmphatic Microsurgical Preventive Healing Approach) technique|Patients will receive a lymphatic-venous anastomosis at time of their required Axillary Dissection
15814650|NCT04328597|Procedure|Inguinal hernia repair|Inguinal hernia repair (open, laparo-endoscopic, robotic)
15814651|NCT04328584|Procedure|surgical navigation system|Navigation system providing surgeons with an additional view of the chest wall lesion
15814652|NCT04328571|Dietary Supplement|OLE enzymatically treated|OLE (Olive leaf extract ) enzymatically treated + maltodextrin
15814653|NCT04328571|Dietary Supplement|OLE + probiotic|OLE (Olive leaf extract) co-administered with probiotic
15814654|NCT04328571|Dietary Supplement|OLE|OLE (Olive leaf extract) + maltodextrin
15814655|NCT04328558|Other|Clavipectoral fascia plane block group|Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.
15814656|NCT04328545|Device|Anodal tDCS on DLPFC|Participants will receive anodal tDCS on the left DLPFC for 30 min duration, cathode will be placed over the right supra orbital area. The electrodes are 25cm², The stimulation current is 2 milliamperes (2mA).
15814657|NCT04328545|Device|Anodal tDCS on M1|Participants will receive anodal tDCS on the left M1 for 30 min duration, cathode will be placed over the right supra orbital area. The electrodes are 25cm², The stimulation current is 2 milliamperes (2mA).
15814658|NCT04328545|Device|Sham tDCS|Participants will receive sham tDCS. The anode will be placed on the left DLPFC and the cathode on the over the right supra orbital area. The electrodes are 25cm², There will be a ram up and down of 30 seconds each, after the ramp up the current will be turned off.
15814659|NCT04328532|Device|MRI|MRI examination (45 min max) with oxygen delivery for 10 min
15814660|NCT04328519|Other|observation|observation
15814661|NCT04328506|Drug|CM082 tablet (test product)|Test product(T)：100mg CM082 tablet manufactured by Betta Pharmaceuticals
15814662|NCT04328506|Drug|CM082 tablet (reference product)|Reference product(R)：100mg CM082 tablet manufactured by Catalent Pharma Solutions
15814663|NCT04328493|Drug|Chloroquine phosphate|"Each chloroquine tablet contains 250mg chloroquine phosphate (or 150mg chloroquine base). Chloroquine treatment for patient is weight-based dosing.
~Chloroquine will be administered orally, as tablets. For unconscious patients chloroquine can be crushed and administered as a suspension via a nasogastric tube.
~The total duration of treatment with Chloroquine will be 10 days"
15814705|NCT04328194|Other|Full medical history|full medical history will be taken from all patients
15814664|NCT04328480|Drug|Colchicine|"The colchicine dosage schedule will vary according to the following scenarios:
~In patients not receiving Lopinavir/Ritonavir
~Loading dose of 1.5 mg followed by 0.5 mg after two hours (day 1)
~The next day 0.5 mg bid for 14 days or until discharge.
~In patients receiving Lopinavir/Ritonavir
~Loading dose of 0.5 mg (day 1)
~After 72 hours from the loading dose, 0.5 mg every 72 hours for 14 days or until discharge.
~Patients under treatment with Colchicine that are starting with Lopinavir/Ritonavir
~Dose of 0.5 mg 72 hours after starting Lopinavir/Ritonavir.
~Continue with 0.5 mg every 72 hours for 14 days or until discharge.
~Only the oral route will be used except in the case of patients associated with mechanical ventilation or with contraindications to the oral route, in whom it will be administered by nasogastric tube."
15814665|NCT04328480|Other|Local standard of care|Local standard of care for COVID-19 SARS moderate /high-risk patients
15814666|NCT04328467|Drug|Hydroxychloroquine|Hydroxychloroquine; 200mg tablet; oral
15814667|NCT04328467|Other|Placebo|Placebo; tablet; oral
15814668|NCT04328454|Other|retrospective analysis|The investigators retrospectively analyzed the hospitalized patients with COVID-19
15814669|NCT04328441|Drug|BCG Vaccine|Intracutaneously 0.1ml BCG vaccine, which accounts for 0.075mg of attenuated Mycobacterium bovis
15814670|NCT04328441|Drug|Placebo|Intracutaneously 0.1ml NaCl 0,9%
15814671|NCT04328428|Other|acupuncture|Use one acupuncture needle insert in a acupoint.
15814672|NCT04328415|Radiation|Cerebral scintigraphy|Radioactive tracer 99mTc-DTPA
15814673|NCT04328402|Diagnostic Test|Polysomnography|Polysomnography, referred to as type I, allows assessing several sleep physiologic parameters (eg, EEG, electrooculogram, electromyogram, electrocardiogram, airflow, respiratory effort, oxygen saturation), whereas audio-video recording enables to document tooth-grinding sounds and distinguishing between rhythmic masticatory muscle activity (RMMA) and orofacial and other muscular activity during sleep. The apnea and hypopnea index (AHI) is defined as the number of obstructive apneas and hypopneas per hour of sleep. Obstructive Sleep Apnea is defined in PSG when AHI≥1 and is divided into the following categories, according to severity: mild OSA (AHI 1-4.9), moderate OSA (AHI 5-9.9) and severe OSA (IAH≥10) (BERRY; BUDHIRAJA; GOTTLIEB, 2012). Based on the RMMA index (number of episodes per hour of sleep), sleep bruxism is diagnosed when episodes are greater than or equal to 2 (low-frequency SB, mild bruxism) or episodes are greater than or equal to 4 (high frequency SB, severe bruxism).
15814674|NCT04328389|Behavioral|electric toothbrush|Participants will be instructed to use their electric toothbrushes twice a day for controlling oral plaque
15814675|NCT04328389|Procedure|Professional oral hygiene|Professional oral hygiene using ultrosound scaling and root planing
15814676|NCT04328376|Diagnostic Test|ECG coupled to phonocardiography|"A standard ECG is recorded along with a phonocardiographic recording. The phonocardiographic recording is obtained by using a specific electronic stethoscope plugged into the auxiliary port of the ECG machine. The recording takes less than 30 seconds. The two recording methods are concomitant.
~QT interval is measured on the ECG recording, EMW is measured with ECG coupled to phonocardiography."
15814677|NCT04328363|Behavioral|Intervention|Social prescription of health assets related to the practice of physical activity and a healthy eating pattern to modify lifestyles.
15814678|NCT04328337|Drug|Intralipid, 20% Intravenous Emulsion|Infusion of Intralipid 20%
15814679|NCT04328337|Drug|Placebos|saline 30 ml/hr for 12 hours through an IV
15814680|NCT04328324|Procedure|Endoscopy|Diagnostic upper Git endoscopy
15814681|NCT04328311|Other|Watermelon Juice|500 mL watermelon juice (What a Melon), containing ~1 g of L-citrulline.
15814682|NCT04328311|Other|Water|500 mL low nitrate water
15814683|NCT04328285|Drug|Hydroxychloroquine|Hydroxychloroquine Oral Tablets
15814684|NCT04328285|Drug|Placebo of Hydroxychloroquine|Placebo of Hydroxychloroquine Oral Tablets Placebo manufactured to mimic Hydroxychloroquine tablets
15814685|NCT04328285|Drug|Lopinavir and ritonavir|LPV/r Oral Tablets
15814686|NCT04328285|Drug|Placebo of LPV/r Tablets|Placebo of LPV/r Oral Tablets Placebo manufactured to mimic LPV/r tablets
15814687|NCT04328272|Drug|Hydroxychloroquine 200 Mg Oral Tablet|Hydroxychloroquine administered orally with water
15814688|NCT04328272|Drug|Azithromycin 500Mg Oral Tablet|Azithromycin administered orally with water
15814689|NCT04328272|Dietary Supplement|Glucose tablets|administered orally with water
15814690|NCT04328246|Device|IES System|The IES system is composed of a stimulator and self-adhesive surface gel electrodes.
15814691|NCT04328246|Other|Standard of Care Therapy|Standard institutional practices for treating pressure injury.
15814692|NCT04328233|Behavioral|Time-Restricted Eating|Participants will reduce the amount of time they eat to 10 hours per day over a 12-week monitored intervention followed by a 12-week self-directed intervention and will log their dietary intake using a smartphone application (mCC app). The participants will select a 10-h eating window that best suits their lifestyle. All food/beverages except water must be consumed within the time-interval. No further dietary restrictions will be applied. The participants will be provided with behavioral nutritional counseling by a dietician.
15814693|NCT04328220|Diagnostic Test|chest ultrasound|"A point-of-care lung ultrasound exam will be performed within 24h of admission to PICU and serial follow up according to each case.
~chest x-ray will be performed for comparison with ultrasound findings."
15814694|NCT04328207|Other|No Financial Incentive|Standard of care eye health education
15814695|NCT04328207|Behavioral|Financial Incentive|Patients who are referred for an in-person follow-up exam will receive a financial incentive once the referral visit is completed.
15814696|NCT04328194|Diagnostic Test|Serum Autotaxin|Marker
15814697|NCT04328194|Radiation|chest x-ray|chest x- ray will be done for the study group
15814698|NCT04328194|Diagnostic Test|Breast ultrasound or mammography|Breast ultrasound or mammography will be done for the study group to diagnosis of breast cancer
15814699|NCT04328194|Diagnostic Test|Histopathological examination of breast mass specimens|by True cut or fine needle aspiration cytology
15814700|NCT04328194|Radiation|Magnetic Resonance Imaging ( MRI) and Bone scan|will be done for the study group
15814701|NCT04328194|Diagnostic Test|Peripheral haemogram|blood sample will be taken from the patients
15814702|NCT04328194|Diagnostic Test|Renal and liver functions|to exclude any other morbidity
15814703|NCT04328194|Diagnostic Test|Prothrombin time and concentration|blood sample will be taken from the patients
15814707|NCT04328181|Device|Spectral Photon Counting Computed Tomography (SPCCT)|"For the dual-layer spectral CT scanner (IQon®, Philips, Amsterdam, The Netherlands), the following parameters will be used for the acquisition:
~Tube potential 120 kVp;
~Tube current time product of 150 mAs;
~Gantry revolution time 0.33 s;
~Automatic exposure control (angular and longitudinal) combined xyz-axis;
~Beam collimation geometry 64 x 0.625 mm - scan field-of-view - 22 cm;"
15814708|NCT04328181|Device|DECT (Dual Energy CT)|"The SPCCT scanner is a prototype spectral photon-counting computed tomography system derived from a modified clinical CT system with a field-of-view (FOV) of 168 mm in-plane, and a z-coverage of 20 mm. It is equipped with energy-sensitive photon-counting detectors relying on the direct conversion high band gap semiconductor of cadmium zinc telluride (CZT). The electronics comprises 5 rate counters with 5 different configurable energy thresholds. The SPCCT scanner has the following parameters:
~Base platform : iCT scanner
~Tube Voltage (kVp) : 120, capability for imaging at 80 and 100 kVp
~Tube current (mA) : 10 - 300
~Spatial Resolution : > 30 lp/cm, ≤ 250 µm
~Z-coverage isocenter (mm) : 20 mm
~FOV (mm) : 500
~Minimum rotation time : 0.33 s/rotation
~Acquisition modes : Axial, Helical, Step & Shoot"
15814709|NCT04328168|Procedure|ROM exercises, stretching, positioning, gait training|
15814710|NCT04328168|Procedure|by two physiotherapist under the supervision of a doctor|
15814711|NCT04328155|Procedure|Hotpack Group|Hotpack Group received 20 minutes hotpack to hamstring muscles region at prone position and participants stretched the hamstring muscles at supine position.Self stretching hamstring exercise was done by straight leg lifting using a band three times for 15 seconds .
15814712|NCT04328155|Procedure|Infrared Group|Infrared Group received 20 minutes infrared to hamstring muscles region at prone position and participants stretchted the hamstring muscles at supine position.Self stretching hamstring exercise was done by straight leg lifting using a band three times for 15. seconds .
15814713|NCT04328155|Procedure|Ultrasound Group|Ultrasound Group received 5 minutes 1 M-Hz, 1,5 watt/cm2 ultrasound therapy to hamstring muscles region at prone position and participants stretched the hamstring muscles at supine position.Self stretching hamstring exercise was done by straight leg lifting using a band three times for 15 seconds .
15814714|NCT04328155|Procedure|Control|Control Group participants stretched the hamstring muscles at supine position.Self stretching hamstring exercise was done by straight leg lifting using a band three times for 15 seconds .
15814715|NCT04328142|Other|Qigong group|Traditional Chinese Medicine exercise programme
15814716|NCT04328142|Other|Physiotherapy|Physiotherapy exercise programme
15814717|NCT04328129|Procedure|Human biological samples|"Blood sample
~Nasopharyngeal swab."
15814718|NCT04328116|Device|Dental Implants|Dental Implants will be used according to standard routine in daily practice, according to all indications as specified by the manufacturer in the IFU (informations for use)
15814719|NCT04328103|Behavioral|Cognitive Behavior Therapy (CBT)|Following established procedures at the DES at NYSPI, 12 sessions of individual manual-driven CBT (Emery, 2000) will be conducted by highly trained master degree clinicians.
15814720|NCT04328103|Behavioral|Nonspecific Supportive Therapy (PBO)|As a non-CBT intervention that includes warmth, genuineness and empathy (Linde et al., 2011), nonspecific supportive therapy (PBO) will be administered in a parallel format to CBT, also consisting of 12 individual sessions.
15814721|NCT04328090|Other|Computer based Antimicrobial stewardship (AMS) intervention system|"Re-evaluation alerts and decision support for the duration of antimicrobial treatment.
~Re-evaluation alerts and decision support for the choice of antimicrobial.
~Quality control audit and feedback."
15814722|NCT04328077|Drug|TERN-101|Investigational drug
15814723|NCT04328077|Other|Placebo|Matching placebo
15814724|NCT04328064|Drug|Rosuvastatin calcium 40mg|Active drug -Rosuvastatin
15814725|NCT04328064|Drug|Placebo oral tablet|40 mg placebo for 12 months
15814726|NCT04328051|Other|Dental Implant Placement|Antibiotic prophylaxis will be done. After rinsing with 0.12 % chlorhexidine, patients will receive local anaesthesia. A crestal incision will be done and a mucoperiostic flap will be raised. As the commercial specifies, progressive diameter drills will be used under constant sterile saline irrigation to prepare the implant site. Once finished the drilling sequence, one investigator will open the opaque envelope to know which type of implant, depending on the connection, has to be placed by the surgeon. Dental implant will be placed crestally and depending if it has primary stability or not, it will be leaded submerged or non-submerged. The flap will be repositioned and sutured without tension with 4/0 polyamide. Postoperative instructions and medication will be prescribed and explained.
15814727|NCT04328038|Other|Survey|Patient fill out a survey containing: Demographic Information, medical history, several Questionnaires about Health Literacy, Well Being/HRQoL and Fatigue
15814728|NCT04328025|Other|Peer-delivered HIV self-testing, STI self-sampling and PrEP|Peer delivery of combination HIV prevention interventions to transgender women.
15814729|NCT04328012|Drug|Losartan|administered 14 days
15814730|NCT04328012|Drug|Placebo|administered 14 days
15814731|NCT04327999|Drug|Artificial Tears|Self-Administered - utilizing eye drop preservative free vials
15814732|NCT04327986|Drug|M7824|IV on Days 1 and 15 of every cycle
15814733|NCT04327986|Drug|M9241|Subcutaneous injection on Day 1 of every cycle
15814734|NCT04327986|Radiation|SBRT|Radiation therapy will be starting on Day 17 (+5 days) of Cycle 1 and continue for 5 consecutive business days.
15814735|NCT04327973|Biological|ATB200|Participants received ATB200 co-administered with AT2221 capsule (Miglustat)
15814736|NCT04327973|Drug|AT2221|Participants received ATB200 co-administered with AT2221 capsule (Miglustat)
15814737|NCT04327960|Diagnostic Test|Cardiac troponin (cTn)|Cardiac troponin (cTn) will be measured with the Dimension RxL-HM analyzer .The one-step enzyme immunoassay is based on cTn specific monoclonal antibodies, performed on a separate module of the analyzer, assay-time is 17 minutes.
15814738|NCT04327947|Other|Hyaluronic acid - Research product 1|Health care product (intimate gel)
15814739|NCT04327947|Other|Hyaluronic acid - Research product 2|Health care product (intimate gel)
15814740|NCT04327947|Other|Hyaluronic acid - Comparator product|Health care product (intimate gel)
15814741|NCT04327934|Drug|GnRH antagonist|GnRH antagonist up to 16 days.
15814742|NCT04327934|Drug|GnRH antagonist + MethylTESTOSTERone 5 MG|GnRH antagonist + MethylTESTOSTERone 5 MG up to 5 days.
15815196|NCT04324138|Drug|Jianpi Qinghua placebo granules|3 times a day and 1 hour after a meal, for 4 weeks
15814743|NCT04327921|Behavioral|Peer navigation social support for smoking cessation|Standard guidelines will be used for brief advice for smoking cessation based on the 5A's. Also, motivational interviewing/guidance will also be used to determine whether enhanced treatment (using a Peer Navigator to navigate smoking cessation, obtain medication and treatment, improve adherence to treatment, and provide social support for quitting) will increase participant's quit attempts and smoking cessation rates.
15814744|NCT04327921|Behavioral|Standard Condition|Standard guidelines will be used for brief advice for smoking cessation based on the 5A's.
15814745|NCT04327908|Other|Questionaire TESS and MSTS|answering TESS and MSTS questionnaire
15814746|NCT04327895|Behavioral|evaluation of the need for training|analyse of results of survey
15814747|NCT04327882|Diagnostic Test|Point-of-care ultrasound|performance of a POCUS: lung and cardiac ultrasound mainly
15814748|NCT04327869|Device|Magnetically controlled capsule endoscopy|The subjects swallowed the capsule with water in the left lateral position. When capsule enter stomach cavity, subject was asked to sit up and ingested 4 g aerogenic powder with 5 ml water to distend the stomach, and performed gastric baseline examinations to identify the lesions. After baseline examination, subjects ingested dyed sucralfate gel and performed the first-time examination. The examination was repeated at 30 min intervals, until dyed sucralfate gel disappeared completely.
15814749|NCT04327856|Procedure|Cataract Surgery|The cataract will be removed from patient's eye and artificial intraocular lens will be implanted
15814750|NCT04327843|Behavioral|Customized Adherence Enhancement|Customized Adherence Enhancement (CAE): CAE targets key areas relevant to adherence in chronic psychotic disorders (CPD): 1.) inadequate understanding of mental disorder, 2.) lack of adequate medication-taking routines, 3.) poor communication with care providers and 4.) substance use which interferes with adherence and recovery. CAE delivered components are selected based upon findings from the ROMI and AMSQ. CAE will be delivered in approximately 8 sessions by a nurse interventionist, ideally at the same time that the long-acting injectable (LAI) is administered.The intervention is guided by a detailed manual and uses components and resources that are available in lower- and middle-income countries (LMICs). Social worker interventionists will be trained to deliver CAE-L.
15814751|NCT04327843|Drug|Haloperidol Decanoate|Long-acting injectable (LAI): Patients on oral haloperidol will be switched to haloperidol decanoate per manufacturer's package insert. Individuals not on antipsychotic medication at the time of screening assessment or who are on a different antipsychotic medication, will receive an oral tolerance test (OTT) consisting of up to 14 days of oral haloperidol 2-5 mg once or twice daily. If the OTT suggests good tolerability, the participant will then receive LAI (haloperidol decanoate) intramuscularly after completion of baseline assessments. Dosing of LAI will be as clinically indicated using conservative dosing to minimize drug-related adverse effects. In the CWRU studies, mean end-point dose of haloperidol decanoate was 68.0 mg, SD 21.1, Range 50-100 mg/monthly injection. It is anticipated that patients will continue on the same dose for 6 months, although dose changes will be permitted based upon clinical status. Each study participant will receive up to 8 injections during the study.
15814752|NCT04327830|Other|Decisional needs assessment|Assessment of decision-making needs
15814753|NCT04327817|Device|Multifidus stimulator|"Patient eligible for the study and have provided consent will have a baseline PET scan. Multifidus ReActiv8 Stimulator will be inserted using standard treatment for lumbar pain at Barts Health NHS Hospitals.
~All patients who receive the Reactiv8 system will continue to receive multifidus stimulation 20Hz for the next 6 months as per standard of care of multifidus stimulation; at the end of this period, the patients will undergo PET scanning and questionnaires. Thereafter, stimulation will continue and 3rd PET scan will be performed at 1year post implant."
15814754|NCT04327804|Diagnostic Test|Odd/Even birth year intervention groups|The nostril used and order of testing will be different in each arm.
15814755|NCT04327791|Drug|Baloxavir|administered PO once
15814756|NCT04327791|Drug|Placebos|administered PO once
15814757|NCT04327778|Procedure|Music Therapy|Automate music therapy every two weeks
15814758|NCT04327765|Combination Product|0.5mg AZ-010|Subject will receive a single inhaled dose (0.5mg) of AZ-010 or matching Staccato Placebo
15814759|NCT04327765|Combination Product|1mg AZ-010|Subject will receive a single inhaled dose (1mg) of AZ-010 or matching Staccato Placebo
15814760|NCT04327765|Combination Product|3mg AZ-010|Subject will receive a single inhaled dose (3mg) of AZ-010 or matching Staccato Placebo
15814761|NCT04327752|Other|dermatological consultation|Dermatological consultation will be done on every children treated by biotherapy for chronic inflammatory disease in the Amiens hospital.
15814762|NCT04327739|Other|Intervention 1 Exercise|• Exercise programme Endurance and Resistant training exercise program (Duration: 45 minutes) • Muscle retraining of longus colli and endurance training of the deep cervical flexors. • Resistant exercises for the muscles involved in neck flexion, extension, side bending and rotation of the neck region. Isometric contractions exercises (20-70% of MVC) and resistant exercises (12-15RM). • Active ROM exercises for the neck muscles • Upper limbs exercises with resistant bands • Stretching exercises for the neck and upper limbs muscles
15814763|NCT04327739|Other|Intervention 2 Exercise and INIT|"Exercise programme same as Intervention Group 1 and
~Integrated Neuromuscular Inhibition Technique application. Integrated Neuromuscular Inhibition Technique application. (Duration: 15min) The protocol was applied to the following muscles: • Upper border of the trapezius muscle • sternocleidomastoid • levator scapulae muscle • splenius capitis muscle Integrated Neuromuscular Inhibition Technique includes the combination of the following technique: • Ischemic compression • Muscle energy technique • Straincounterstrain technique"
15814764|NCT04327739|Other|Intervention 3 Exercise and SMT|"Exercise programme same as Intervention Group 1 and
~Manipulation Care. Participants allocated to this group received Spinal Manipulation Therapy after the therapeutic exercise programme. Treatment was delivered by 1 chiropractor with a minimum 5-year experience of clinical practice. Pain provocation and static/motion palpation findings were used to determine areas of treatment in the cervical spine. The Manipulation Therapy technique included joint motion using a diversified thrust technique, and mobilization, a low-velocity type of joint oscillation. The type and the force of the applied spinal manipulation were individualized according to the age and physical condition of each participant. Soft passive stretching, light massage and hot packs were applied to the cervical and upper thoracic area before manipulation in order to prepare each participant."
15814765|NCT04327739|Other|Control|Participants allocated to this group received general consulting istructions and a home based general exercise sheet
15814766|NCT04327726|Drug|Dexmedetomidine Nebulization|ultrasonic nebulization of 1 µg/kg dexmedetomidine for PDPH treatment
15814767|NCT04327726|Other|0.9% Saline Nebulization|nebulization of 4mL 0.9% saline
15814768|NCT04327713|Dietary Supplement|fish oil supplement|daily fish oil supplement vs. placebo
15814769|NCT04327700|Device|TheraBionic|Amplitude-modulated electromagnetic fields will be self-administered and given continuously to patients in three courses of 60-minute treatments per day, administered in the morning, at noon and in the evening at the patient's home, with the exception of the first 60-minute treatment, which will be delivered at the research site. Each 4 week treatment period will be considered a cycle of treatment.
15814770|NCT04327700|Drug|Regorafenib|Patients will receive 160 mg regorafenib (four 40 mg tablets) orally once daily for the first 3 weeks of each 4-week cycle per approved prescribing information.
15814771|NCT04327687|Device|Remote ischaemic conditioning|5 cycles of 5 minutes of upper limb ischaemia followed by 5 minutes of reperfusion. This will be delivered using a manual sphygmomanometer applied to the upper arm and activated to go through 5 such cycles automatically. The blood pressure cuff in the active treatment arm will inflate to 200 mmHg. RIC will be completed 1-2 times per day for six months.
15814772|NCT04327687|Other|conventional therapy|conventional therapy
15814773|NCT04327661|Drug|Tradipitant High Dose|Oral Capsule
15814774|NCT04327661|Drug|Tradipitant Low Dose|Oral Capsule
15814775|NCT04327661|Drug|Placebo|Oral Capsule
15814776|NCT04327648|Device|Social interaction treatment|Children in social interaction treatment group will have 30min social interaction each day for 3 months.
15814777|NCT04327648|Device|Neuronal cognition treatment|Children in neuronal cognition treatment group will experienced neural cognition training 30min each day for 3 months.
15814778|NCT04327648|Other|Routine treatment|Children in routine treatment group will keep the same initial treatment.
15814779|NCT04327635|Drug|PEP in Acute Myocardial Infarction|PEP dosage will consist of 5%, 10%, or 20% PEP. PEP dose will be infused immediately distal to the newly placed stent over approximately 5 minutes.
15814780|NCT04327609|Device|SELUTION SLR™ DEB|Subjects will receive standard high-pressure balloon angioplasty followed by local application of sirolimus with the SELUTION SLR™ 018 DEB (MedAlliance) of appropriate diameter and length to achieve full lesion coverage.
15814781|NCT04327609|Device|Control Arm|The control arm will receive standard high-pressure balloon angioplasty of appropriate diameter and length and no further lesion treatment.
15814782|NCT04327596|Procedure|RF ablation of AF using CARTO 3 and a Thermocool ST SF ablation catheter|Ablation of AF is standard of care in the management of patients with paroxysmal or persistent AF. The most common triggers initiating AF arise from pulmonary veins (PV) and successful electrical isolation of PV's can significantly reduce the burden of AF. Therefore, the main objective in patients undergoing ablation of AF is to achieve PV isolation.
15814783|NCT04327583|Behavioral|IPPACTTO|"The coordinated experimental pharmaceutical path consists of 7 pharmaceutical interviews or consultations. One initial pharmaceutical consultation with the hospital pharmacist. Five follow-up pharmaceutical interviews with the dispensary pharmacist. One follow-up pharmaceutical consultation with hospital pharmacist.
~Each pharmaceutical interview or consultation will result in the drafting of a pharmaceutical report to be sent to the other participating health professionals. At each pharmaceutical consultation or interview, the pharmacists requested perform a clinical pharmaceutical analysis of drug prescriptions; Evaluate the patient's understanding; Detect adherence problems, Identify drug related problems; Alert the oncologist and / or the attending physician."
15814784|NCT04327570|Other|Patient sampling|Blood draw, NP/rectal swab, bronchoscopy if clinically indicated, lung tissue if applicable
15814785|NCT04327557|Behavioral|MBCP Childbirth Education Course|The MBCP program is a fully manualized childbirth and parenting preparation course. Developed in 1998 in a clinical context, MBCP is an enhanced version of the Mindfulness Based Stress Reduction (MBSR) program tailored for addressing the concerns of pregnancy and early parenting. Through MBCP, pregnant women and their partners learn mindfulness skills for coping with the anxiety and stress of pregnancy and parenting, and the pain and fear of childbirth. They are given explicit instruction in skills for cultivating positive emotion and developing mindful, sensitive parenting. MBCP groups meet weekly for 9 weeks, with a retreat day between weeks 6 and 7.
15814786|NCT04327557|Behavioral|Non-MBCP Childbirth Education Course|TAU control participants will undergo standard (real-world) hospital- or community-based childbirth education that does not have a mindfulness focus. They will be able to choose whichever class they want from the list. If they prefer a class that is not on the list, then study staff will obtain the syllabus for that class to check whether there is a mindfulness component.
15814787|NCT04327544|Behavioral|Frailty Intervention|In overall, participants will attend one session of frailty talk, 22 sessions of low to moderate intensity of multi-components exercise course and 6 session of nutrition education interventions. Both nutritional education and exercise intervention will be conducted concurrently for a 12-week (3-month) of intervention period. Noted that every session will be held in PPR flats' facility area or hall around 60 minutes that will be conducted by the dietitian or nutritionist and physiotherapist from the research team.
15814788|NCT04327531|Behavioral|turkish physicians|turkish physicians, who work active in pandemic hospital.
15814789|NCT04327518|Device|TECNIS® Toric II|Toric Intraocular Lens
15814790|NCT04327505|Drug|Hyperbaric oxygen|1.6- 2.4 ATA, 30-60 min (excluding compression/recompression)
15814791|NCT04327492|Diagnostic Test|Biomarker - FGF 23; troponin I; PCR - high sensitivity; BNP|peak wave velocity; gray weale plaque classification
15814792|NCT04327479|Diagnostic Test|Assessment of cardiovascular diseases and cardiovascular risk factors|At inclusion, patients will be screened for pre-existing cardiovascular diseases and cardiovascular risk factors, as well as medication.
15814793|NCT04327466|Device|Osciflow|Osciflow is a non-invasive high frequency oscillatory ventilation support delivered via a highflow nasal cannula for four hours (one hour wash-out, three hours measurement period).
15814794|NCT04327466|Device|Highflow|Standard highflow therapy without oscillations delivered via a highflow nasal cannula for four hours (one hour wash-out, three hours measurement period).
15814795|NCT04327453|Device|double antibiotic paste with XP-endo Finisher file|XP-endo Finisher files (FKG Dentaire, La Chaux-de-Fonds, Switzerland). file will be used with an endodontic motor X-Smart (Dentsply Sirona, Ballaigues, Switzerland) in removal of double antibiotic paste
15814796|NCT04327453|Device|double antibiotic paste with Irrisafe Ultrasonic tip|passive ultrasonic irrigation (PUI) with an IrriSafe Ultrasonic tips (Acteon,France), which will be driven by an ultrasonic device (Newtron P5, Satelec, Acteongroup, Merignac, France) in removal of double antibiotic paste
15814797|NCT04327453|Device|double antibiotic paste with side vented needle|conventional syringe irrigation with side vented needle (prime Dent, India) in removal of double antibiotic paste
15814798|NCT04327440|Biological|RTS,S/AS01 malaria vaccine|Malaria vaccine: RTS,S is a subunit vaccine that includes a portion of the circumsporozoite protein (CSP) co-expressed with Hepatitis B surface antigen combined with an adjuvant. The Phase 3 trial of three doses administered to 5-17-month-olds confirmed moderate protection, with overall efficacy estimates of 50.4% against clinical malaria and 34.8% against severe malaria after three doses. Efficacy, which waned over time, was marginally improved by boosting at 18 months. The European Medicines Agency adopted a positive scientific opinion of the vaccine for use outside of the European Union. The World Health Organization has created the Malaria Vaccine Implementation Program (MVIP) and selected Malawi as one of the sites to explore the feasibility, efficacy and safety of RTS,S vaccination in the context of routine use.
15814799|NCT04327440|Other|PBO bed nets|PBO nets: The PBO nets represent a new formulation of insecticide-treated bed nets with a chemical synergist, piperonyl butoxide (PBO), designed to enhance the insecticidal effect of pyrethroids. They seem to be helpful in areas like Malawi where insecticide-resistance is increasing. PBO inhibits the enzyme that detoxifies the pyrethroid, allowing the pyrethroid to act on the mosquito. The impact of PBO net use was also detectable in key entomological measures including Anopheles density, sporozoite rate and entomological inoculation rates. Following these promising preliminary results in Tanzania, Malawi's National Malaria Control Program (NMCP) is piloting the use of PBO-nets iin one of our two study sites, presenting us with the opportunity to study the effectiveness of these nets in the context of real-world program setting
15814800|NCT04327427|Other|Aspirin|Outcome Analysis of Aspirin in liver transplantation
15814801|NCT04327414|Behavioral|Intervention group|Standing desks
15814802|NCT04327401|Drug|Dexamethasone|Dexamethasone administration for 10 consecutive days after randomization.
15814803|NCT04327388|Drug|Sarilumab SAR153191|Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion
15814804|NCT04327388|Drug|Placebo|Pharmaceutical form: Solution for injection Route of administration: Intravenous infusion
15814805|NCT04327375|Other|Observational|Observational
15814806|NCT04327362|Device|Transcranial Direct Current Stimulation (tDCS)|Participants will receive 20 min. of either sham or active tDCS prior to PE sessions using a 1 x 1 tDCS device with a ring electrode configuration that allows relatively excitatory and focal stimulation of the dorsomedial prefrontal cortex (dmPFC). Electrodes consist of sponges in a silicone rubber holder with a metal mesh conductor saturated with normal saline. A center anode (2.5 cm diameter) and a ring-shaped cathode (diameter inner/outer: 9.2/11.50 cm) will be centered over the dmPFC, with the anode placed the midline at 15% of the Fz to FPz distance. Active stimulation will commence with a 15 sec. ramping up period to target current (1.5 mA), followed by constant current for 20 min., and a 15 sec. ramping down period. For all sham sessions, stimulation will be immediately ramped down over a 15 sec. period following the initial ramping up period, and subsequently ramped up over 15 sec. prior to the final ramping down period.
15814807|NCT04327362|Behavioral|Prolonged Exposure Therapy|All participants will receive 10 weekly sessions of standard Prolonged Exposure Therapy, or PE, which is a gold standard trauma-focused cognitive behavioral treatment for PTSD. The first sessions (1-2) predominately consist of psychoeducation about PTSD and the rationale for treatment, whereas subsequent sessions (3-10) consist of imaginal and in vivo exposure, involving repeated, prolonged, systematic, and deliberate practice approaching trauma reminders, as well as cognitive and emotional processing reactions to an index trauma memory.
15814808|NCT04327349|Biological|Convalescent Plasma|Intervention to evaluate convalescent plasma transfer to COVID-19 patients admitted to ICU
15814809|NCT04327336|Device|Manual Non invasive ventilation titration|Manual Group: during a complete polysomnography, adding transcutaneous capnography and the basic ventilators curves, the ventilators setting will be adjusted in order to correct respiratory events and patient-ventilator asyncrony. A 10 hours face-to-face investigator training meeting is programmed before opening the inclusion period.
15814810|NCT04327336|Device|Automatic Non invasive ventilation titration|Automatic Group: the A40 ventilator in the automatic AVAPS mode will be adjusted in order to achieve 8-10 ml/kg of ideal weight.
15814811|NCT04327323|Device|CCM device implantation|CCM implantation involves the introduction of two active fixation stimulation leads, fixed on the interventricular septum, and connected to the CCM generator (Optimizer Smart IV, Impulse Dynamic, and any subsequent versions of the same device) inserted in the subcutaneous or submuscular pocket. The implantation is ususally performed using vascular access via right or left cephalic or subclavian vein. The CCM signal consists of 2-3 biphasic pulses lasting 10 msec (total duration of about 20 ms) with an amplitude between 4.0 and 7.5 V, delivered during the absolute refractory period of the ventricle, at a distance of 40 msec from ventricular sensing. The CCM device is compatible with other pacing and defibrillation devices already implanted in the patient; at the time of the implantation, the devices are checked in order to confirm the absence of interference between the devices. The patient is instructed to charge the device battery weekly.
15814812|NCT04327310|Drug|Meplazumab for Injection|humanized mAb against CD147
15814813|NCT04327310|Drug|Sterile normal saline (0.9%)|Sterile normal saline (0.9%)
15814814|NCT04327297|Dietary Supplement|Amino acid-based formula|Amino acid based formula is formula which is used as dietary supplement instead of dairy products in cow's milk allergic infants
15814817|NCT04327271|Behavioral|Text-based VMMC follow-up|2wT clients will receive automated daily texts from days 1-13. If a 2wT VMMC client responds that he suspects an AE, a VMMC nurse will exchange modifiable, scripted texts with clients to determine symptoms, frequency, and severity. Then, if deemed necessary, the client will be asked to return to clinic the following day or earlier. If 2wT patients do not respond to texts or return for any visit by day 14, they will be traced by SMS, phone or home visit. All study participants will be asked to come to the clinic for study-specific, Day 14 follow-up to review healing and verify adverse event reporting. At Day 21, we will implement a brief text-based survey with 2wT clients to ascertain complete healing, providing stronger inferences at study completion.
15814818|NCT04327245|Other|Intervention ingest a 5000 mg of D-tagatose|"Woman with resistance insulin who ingest a 5000 mg of D-tagatose. D-tagatose is a sweetener of natural origin, low in calories (1.5 kcal / g) and with a sweetness power of 0.9.
~About 20 to 25% of the ingested D-tagatose is absorbed and metabolized in the liver, the rest is fermented by the microbiota producing short chain fatty acids."
15814819|NCT04327245|Other|Intervention ingest a 15,3 mg of stevia|"Woman with resistance insulin who ingest a 15,3 mg of stevia (steviol glycosides). The word stevia refers to the whole plant of Stevia rebaudiana Bertoni (SRB), only some of the components of the stevia leaf are sweet. Steviol glycosides are up to 300 times sweeter than sucrose, do not provide calories and can be used as a substitute for sucrose or as a non-nutritive sweetener alternative. Your allowable daily intake is 4 mg / kg / body weight (expressed as steviol)"
15814820|NCT04327232|Drug|Spironolactone 25mg|Mineralocorticoid Receptor Antagonists
15814821|NCT04327232|Drug|Placebo oral tablet|Placebo
15814822|NCT04327219|Other|CDED diet|examine the microbial, mucosal and immunological changes of the pouch during one year post IPAA, and examine the impact of the CDED on disease activity and dysbiosis in adults suffering from active pouchitis.
15814823|NCT04327206|Drug|BCG Vaccine|"Freeze-dried powder: Live attenuated strain of Mycobacterium bovis (BCG), Danish strain 1331.
~Each 0.1 ml vaccine contains between 200000 to 800000 colony forming units. Adult dose is 0.1 ml given by intradermal injection"
15814824|NCT04327206|Drug|0.9%NaCl|0.9% Sodium Chloride Injection
15814825|NCT04327193|Procedure|Titrated PEEP based on driving pressure|Alveolar recruitment and PEEP titration is performed at three time points: after intubation, after Trendelenburg, and after supine after CO2 deflation. The level of PEEP which makes the driving pressure lowest is selected and applied during the operation.
15814826|NCT04327193|Procedure|Conventional PEEP|Alveolar recruitment is performed at three time points: after intubation, after Trendelenburg, and after supine after CO2 deflation. Conventional PEEP (5cmH2O) is applied during the operation.
15814827|NCT04327167|Behavioral|Video and questionnaire|Potential donors would be shown a video and asked to complete a questionnaire to capture change in attitude towards donation.
15814828|NCT04327154|Device|TISSIUM™ Nerve Coaptation Device|Placement of the TISSIUM™ Nerve Coaptation Device on repair site to achieve an end-to-end nerve coaptation.
15814829|NCT04327141|Behavioral|PP-IF|Protein pacing and intermittent fasting
15814830|NCT04327141|Behavioral|HH|Heart Healthy
15814831|NCT04327128|Device|LifePod|The intervention group is testing LifePod on a digital communication platform between patient and healthcare provider
15814832|NCT04327115|Procedure|"Control strategy"|"Patients included in the control group will received the usual cares of the unit during their stay : support in the gestures of daily life and walking according to their ability and at the discretion of the care teams."
15814833|NCT04327115|Procedure|"Intervention strategy"|"Patients included in the intervention group will received the usual cares of the unit during their stay : support in the gestures of daily life and walking according to their ability and at the discretion of the care teams.
~They will also get a physical activity program realized with a nurse or a nursing assistant, twice a day (morning and evening) for 5 days. The intervention consists of physical support with mimed instructions, the nature of which depends on the falling risk of the participant :
~High falling risk : out of bed exercise (on a chair for at least 30 min)
~Mild falling risk : out of bed exercise + in front of chair (The participant stands standing in static equilibrium to a chair holding the back of it for 2 minutes, on both feet or one foot)
~Low falling risk : out of bed exercise + in front of chair + FTSS exercise (The participant performs a transfer activity of sitting to standing repeated 5 times, with physical assistance or not)"
15814834|NCT04327102|Behavioral|Health education tools combined with health literacy intervention|On the basis of the control group, the intervention measures to improve the health literacy of patients were implemented and self-made health education tools were used. During hospitalization, health knowledge lectures shall be organized for patients. Before the activity, the theme of the activity shall be clarified. Each participant shall be organized by the educator to sit on the tool chart in a U-shape. According to the theme of the tool map, patients interact with educators. And learn the knowledge content related to hypertension health literacy. Before the end of the activity, the educator will review all the contents discussed in the activity quickly, answer the questions in the activity, and help the participants to sort out and consolidate the knowledge acquired in the education. Follow up intervention for patients after leave hospital.
15814835|NCT04327089|Drug|Setanaxib|Nox 1/4 inhibitor
15814896|NCT04326595|Procedure|surgical and medical evacuation|surgical evacuation:the dilation of the cervix and surgical evacuation of the uterus (potentially including the fetus, placenta and other tissue) medical evacuation: induction of abortion by the use of ecbolics
15814897|NCT04326582|Other|Observation|Determine of percentage of each type of arthritis in children, it's prognosis and outcome of treatment in comparison with international guidelines
15814898|NCT04326569|Other|Blood sample|Blood sample to quantify copeptin
15814836|NCT04327076|Device|Using robot system of endotracheal intubation and airway cleaning|"Using the control screen to control the machine, the device first extends the intubation guide rail to the mouth of the patient's oropharyngeal ventilation tube, first sends the magnetic guide strip into the epigarynx, and at the same time, extends the magnetic anchoring unit to the patient's neck. The external magnetic anchoring unit can sense and attract the magnet on the magnetic guide strip. At this point, the machine can send the guide strip into the respiratory tract.
~Then, the control machine sends the tracheal intubation into the airway along the guide strip, and completes the balloon inflation to complete the endotracheal intubation operation.
~During or after the operation, when the sputum suction operation is needed, the parameters of the sputum suction machine are set on the operation screen to start the sputum suction operation, and the suction robot completes the sputum suction operation automatically."
15814837|NCT04327063|Drug|Saline|Injection of the solution of Saline not exceeding 30 mL of maximal volume.
15814838|NCT04327063|Drug|Ropivacaine|Dilution of Ropivacaine 7.5 mg/ml to 5 mg/ml not to exceed 3 mg/kg of maximal dose and 30 ml of maximal volume
15814839|NCT04327050|Procedure|Magnetic anchored guided endoscopic submucosal dissection|Using magnetic anchoring technology, the magnetic pulling unit is anchored to the abdominal wall, and micro surgical tweezers are used. The tumor tissue is pulled indirectly, so that the mucosa is lifted up, which is beneficial to the peeling of the submucosa.
15814840|NCT04327037|Biological|Expanded Haploidentical Natural Killer cells|One dose (from 20x to >100x 10^6 /kg) of expanded haploidentical NK cells
15814841|NCT04327037|Drug|IL-2|6 doses of IL-2 (1 × 10^6 units/m2) from -1 day every other day.
15814842|NCT04327024|Drug|Verinurad|"The treatment will be titrated in 3 steps for rarget low dose (3 mg), intermediate dose (7.5 mg) and high dose (12mg/ 24mg) of verinurad.
~Drug: Allopurinol The treatment will be titrated in 3 steps. Low dose (100mg), intermediate (200mg) and high dose (300mg) of allopurinol."
15814843|NCT04327024|Drug|Allopurinol|Study treatments will be titrated in 3 steps: Low dose (100mg), intermadiate (200mg) and high dose (300mg) of allopurinol
15814844|NCT04327024|Drug|Placebo for verinurad|Matching Capsule
15814845|NCT04327024|Drug|Placebo for allopurinol|Matching tablet
15814846|NCT04327011|Biological|Toca 511 vector|Toca 511 consists of a purified retroviral replicating vector encoding a modified yeast cytosine deaminase (CD) gene. The CD gene converts the antifungal 5-flurocytosine (5FC) to the anticancer drug 5-FU in cells that have been infected by the Toca 511 vector
15814847|NCT04327011|Drug|Toca FC • Flucytosine • 5-FC • 5-Fluorocytosine|Toca FC is an extended-release formulation of flucytosine.
15814848|NCT04326998|Procedure|solvent|using solvent (GuttaClear) in procedure
15814849|NCT04326998|Procedure|non-solvent|non-solvent
15814850|NCT04326985|Biological|Autologous Mesenchymal Stem Cells Treatment (MSCs)|The MSCs treatment group patients will receive an intra-articular injection of a mesenchymal stem cell (MSCs) suspension in the affected knee.
15814851|NCT04326985|Drug|Hyaluronic acid (HA)|The HA group patient will be given a single intra-articular injection of hyaluronic acid sodium salt, Synvisc-One (TRB Chemedica Ltd.)
15814852|NCT04326972|Device|ultrasound|• All patients with inclusion criteria do for them chest ultrasound .
15814853|NCT04326959|Biological|Umbilical Cord-Mesenchymal Stem Cells and Conditioned Medium|Injection of Allogeneic Umbilical Cord Mesenchymal Stem Cells 2 million cell/cm3 in Nacl 1 cc/million cell and booster with Conditioned Medium 1 cc/cm3 in 3 weeks later. All treatment via intralesional injection. The maximum size of the keloid is 15 cm.
15814854|NCT04326959|Biological|Conditioned Medium|Injection of Conditioned Medium 1 cc/cm3 and booster with Conditioned Medium 1 cc/cm3 in 3 weeks later. All treatment via intralesional injection. The maximum size of the keloid is 15 cm.
15814855|NCT04326959|Biological|Triamcinolone Acetonide|Injection of Triamcinolone Acetonide 40 mg/cc/cm3 and booster in 3 weeks later. All treatment via intralesional injection. The maximum size of the keloid is 15 cm.
15814856|NCT04326946|Device|Alfapump|alfapump implementation
15814857|NCT04326933|Drug|Tyrosine kinase Inhibitors (Imatinib & Nilotinib)|Administration of tyrosine kinase inhibitors (Imatinib in a dose of 400mg/day & Nilotinib in adose of 600mg/day)
15814858|NCT04326920|Drug|Sargramostim|Inhalation via mesh nebulizer and/or IV administration upon Clinical deterioration
15814859|NCT04326920|Other|Control|Standard of care
15814860|NCT04326907|Procedure|Autologous centrifuged adipose tissue (CAT) injection after anal fistulectomy|Collection and injection of autologous adipose tissue in complex anal fistulas in one surgical step under locoregional or general anesthesia.
15814861|NCT04326894|Drug|25 mg/week oral methotrexate tablets|
15814862|NCT04326894|Drug|25mg/week oral placebo tablets|
15814863|NCT04326881|Drug|SHR-1314|single dosing
15814864|NCT04326868|Drug|Benzimidazole Anthelmintic|The participants diagnosed positive will be randomly assigned to one of the following treatment arms of the study. Parents or guardians of eligible children will be asked to bring them to the CERMEL (clinic). after a brief clinical examination child fulfilling inclusion criteria will be randomly assigned to one of the following treatment regimens of the study.
15814865|NCT04326855|Other|Incremental shuttle walking protocol (ISWT)|Patients will perform an incremental shuttle walk test to the limit of tolerance to establish peak walking speed. The test will be developed in a 10-m course corridor, and it will be externally-paced via a recorded metronome that gives a signal for each stride. The walking pace will be increased every minute and the test will be terminated when the individual is no longer able to keep up the pace. Pulmonary variables will be recorded breath-by-breath. Cardiac output will be assessed every min. Arterial oxygen saturation will be measured by a pulse oximeter. Patients will score the intensity of their breathlessness and leg discomfort using the 1-10 Borg's scale every minute.
15814866|NCT04326855|Other|Endurance shuttle walking (ESW) protocol|Subsequently, during the second visit all patients will perform the continuous endurance shuttle walk (ESW) protocol to the limit of tolerance at a walking speed corresponding to 85% of VO2 peak derived by the ISWT (visit 1). During the ESW protocol patients will receive standardized instructions to walk for as long as possible although there will be a predetermined 6 minute maximum point. No further encouragement will be provided during the exercise performance. The test will be terminated when the individual is no longer able to keep up the pace or stops due to intolerable exertional symptoms. Gas exchange and cardiorespiratory variables will be assessed as per visit 1.
15814938|NCT04326257|Drug|Nivolumab+Ipilimumab|IV administration of both Nivolumab and Ipilimumab
15814867|NCT04326855|Other|First Intermittent shuttle walking protocol|All patients will perform an intermittent shuttle walking protocols to the limit of tolerance (visit 3) by alternating 1-min walking bouts sustained at a walking speed equivalent to 85% peak (equivalent to the continuous ESW protocol) with 1-min rest periods.The test will be terminated when the individual is no longer able to keep up the pace or stops due to intolerable exertional symptoms although there will be a predetermined 20 minute maximum point.Gas exchange and cardiorespiratory variables will be assessed as per visit 1.
15814868|NCT04326855|Other|Second Intermittent shuttle walking protocol|To obtain test re-test reliability in terms of distance walked, of cardiorespiratory and symptoms responses this intermittent shuttle walking protocol will be repeated on a different day (visit 4). The test will be terminated when the individual is no longer able to keep up the pace or stops due to intolerable exertional symptoms although there will be a predetermined 20 minute maximum point. Gas exchange and cardiorespiratory variables will be assessed as per visit 1.
15814869|NCT04326855|Other|Focus group study|Semi-structured interviews to explore patients' preferences of undertaking the intermittent or continuous ESW protocols and healthcare professionals' perceived factors affecting the implementation of these protocols in the PR setting. These semi-structured interviews consist of questions in some degree predetermined order but still ensures flexibility in the way issues are addressed to the patients. Conversation is sustained in an informal tone and lasts for about an hour. Participants are allowed for an open response in their own words.
15814870|NCT04326842|Procedure|Carotid artery revascularization procedure|The patients with carotid artery stenosis will be examined before and after finishing the carotid artery revascularization procedure.
15814871|NCT04326842|Device|Optical coherence tomography angiography|Examination will be performed using optical coherence tomography angiography. This device allows quantitative analysis, since it provides numerical data about flow area and flow density maps.
15814872|NCT04326829|Drug|QL1604|QL1604, IV infusion
15814873|NCT04326816|Procedure|Rehabilitation of severely worn dentitions using minimally invasive composite restorations (Estenia C&B or Clearfil AP-X, Kuraray, Osaka, Japan)|
15814874|NCT04326803|Biological|Hepatitis B recombinant vaccine|Administration of 20 mcg of hepatitis B recombinant vaccine im at month 0, 1 and 2
15814875|NCT04326790|Drug|Colchicine|Low-dose colchicine treatment, 0.5 mg bid
15814876|NCT04326790|Drug|Standard treatment|Standard treatment
15814877|NCT04326777|Procedure|Ballon pulmonary angioplasty|Percutaneous vascular access for BPA is via the femoral vein using Seldinger technique. A 5Fr sheath is inserted into the vein, through which a 6Fr long introducer sheath is advanced into the pulmonary artery. Subsequently, a 6Fr guiding catheter is advanced into the pulmonary artery being treated. Generally, selective pulmonary angiography should be performed to evaluate lesion feature before BPA. Then a 0.014-inch guidewire is used to cross the lesion, a balloon catheter of an appropriate diameter is selected to dilate the lesion.
15814878|NCT04326764|Drug|Panobinostat|"Panobinostat should be taken orally once on each scheduled day at about the same time, either with or without food. Each dose of panobinostat should be taken with a cup of water.
~The capsules should be swallowed as whole. If vomiting occurs during the course of treatment, no re-dosing is allowed before the next scheduled dose. If one dose is forgotten during the morning on a scheduled treatment day then the missed dose should be taken on that same day within 12 hours. After more than 12 hours, that day's dose should be withheld, and the patient should wait to take panobinostat until the next schedule treatment day. The patient should then continue treatment with the original dosing schedule.
~Panobinostat will be administered at a dose of 20 mg three times weekly (TIW) every second week and will be dosed on a flat scale of mg/day and not by weight or body surface area.
~Panobinostat will be dispensed as a 20 mg capsule or as two 10 mg capsules."
15814879|NCT04326738|Drug|Midazolam|M group received intravenous injection of 0.03mg·kg-1 (1mg·ml-1) midazolam, After 1 min, both groups received intravenous injection of dexamethasone sodium phosphate injection of 10mg (injection was completed in 2s)
15814880|NCT04326738|Drug|normal saline|N group received corresponding intravenous normal saline of1ml·kg-1 .
15814881|NCT04326725|Drug|Plaquenil 200Mg Tablet|health workers under risk who took this medications
15814882|NCT04326712|Other|conventional manufactured socket|Presssure disturubition will be measured in conventional manufactured socket during walking and stairing up and down activities in unilateral transtibial amputees
15814883|NCT04326712|Other|3D manufactured socket|Presssure disturubition will be measured in 3D manufactured socket during walking and stairing up and down activities in unilateral transtibial amputees
15814884|NCT04326699|Procedure|Bilateral SIJ injection|under US guidance a 22G spinal needle, where 1 mL 2 % lidocaine hydrochloride (xylocaine, AstraZeneca) mixed with triamcinolone 40 milligrams (Kenacort, Bristol Myers Squip) will be injected in each SIJ
15814885|NCT04326686|Other|Dietary intervention: nuts and wholegrains with dietary advice for a blood-pressure lowering diet|30g mixed unsalted tree nuts (almonds, hazelnuts and almonds) per day; 3 portions of wholegrain foods per day (including wholegrain cereal products, wholegrain bread and wholegrain pasta); guidance for following the Dietary Approaches to Stop Hypertension (DASH) diet
15814886|NCT04326673|Other|Testosterone Measurements in healthy volunteers after fasting|salivary testosterone measurements taken in morning and evening and a single blood test for testosterone taken
15814887|NCT04326673|Other|Testosterone Measurements after glucose loading|salivary tstosterone and blood testosterone measurements
15814888|NCT04326660|Other|SCOPE-Chinese Women|SCOPE-Chinese Women is a smart-phone based intervention that includes a Fitbit tracking device to monitor daily activity, 12-weeks of educational modules delivered by WeChat, and Bi-weekly messages that encourage positive behavioral change. The data will be examined by the research team to assess efficacy of the intervention.
15814889|NCT04326647|Other|Kinesiotaping|We used kinesiotaping in gastrocnemius and lumbar back
15814890|NCT04326647|Other|Exercise|Exercises about balance and gait
15814891|NCT04326634|Other|controlled exercises|controlled exercises
15814892|NCT04326634|Other|non controlled exercises group|non controlled exercises
15814893|NCT04326621|Other|Pressure Release Technique (PRT)|A pressure applied on muscles trigger points with the finger of a physiotherapist and exercises
15814894|NCT04326621|Other|Control|exercises
15814895|NCT04326608|Other|physiotherapy|manual therapy and sef-care exercises
15815005|NCT04325763|Drug|Anlotinib|a multi-target receptor tyrosine kinase inhibitor
15814899|NCT04326556|Other|Prospective cohort for etiological and prognostic purposes|Subjects benefit from a standardized, comprehensive geriatric evaluation in accordance with the recommendations of good practice during a geriatric consultation. It is completed by a measurement of the gripping force using a dynamometer and a measurement of the respiratory parameters (vital capacity) using a spirometer. The following acts are added to the consultation: the completion of questionnaires, a semi-directed interview focused on the perception of air pollution, the wearing on the chest for one week of an individual mobile physiological signal sensor (DM with CE marking) and the wearing (on the belt or in a bag) for one week of a portable device with two air pollution sensors.
15814900|NCT04326543|Diagnostic Test|Swanson, Noolan and Phelham - IV edition (SNAP-IV); Conners' Parent Rating Scales (CPRS)|"Ratings on the Swanson, Nolan and Pelham Evaluation Scale - IV (Bussing et al., 2008), were assessed during baseline visit for participants at the time of research assessment, to exclude the presence of ADHD symptoms in the healthy subjects. This scale is composed of 26 items for ADHD symptoms and ODD and was administered at baseline and at follow-up visit.
~Temperament assessment: we used the Mary Rothbart's Temperament Questionnaire, a caregivers' report measure designed to provide a detailed assessment of temperament.
~ADHD Rating scales: the Long Version of Conners' Parent Rating Scale (Conners et al., 1998) was used to quantify ADHD comorbidity symptoms, as ODD and Anxiety traits, in the children and adolescents with ADHD.
~Salivary cortisol: Sampling was performed during one ordinary weekday between 7 and 8 o'clock, within 60' after nocturnal awakening."
15814901|NCT04326530|Device|Pneumopipe® (European patent 12425057.2, Rome, Italy)|Collection of VOCs on a cartridge after that the child has normally breathed in it for 3 min, both at the baseline and at the last visit.
15814902|NCT04326530|Other|Other assessments|"Spirometry, both at the baseline and at the last visit.
~24-hour urine collection, both at the baseline and at the last visit."
15814903|NCT04326517|Procedure|Nephrectomy|Different therapeutic options are described in literature for emphysematous pyelonephritis. In our center, medical treatment (no invasive procedure), ureteral stent (endourologic procedure), percutaneous drainage (minimally invasive procedure), and nephrectomy are the therapeutic options for this disease.
15814904|NCT04326504|Other|No intervention|This will be an observational study, no intervention will be performed
15814905|NCT04326491|Diagnostic Test|Breath Biopsy|Analysis of breath samples to identify volatile molecules specific to HCC
15814906|NCT04326478|Drug|Azithromycin|Enrolled children in the intervention arm of this study will receive a single weight-based dose of azithromycin (20 mg/kg, to a maximum dose of 1 gram) administered by a trained study nurse within 12 hours of a member of their household testing positive for cholera.
15814907|NCT04326478|Biological|Placebo|Enrolled children in the placebo arm of this study will receive a single dose of non-antibiotic placebo administered by a trained study nurse within 12 hours of a member of their household testing positive for cholera.
15814908|NCT04326465|Device|Fractional Carbon Dioxide Laser Therapy at 10-15% Laser Density Coverage|Fractional Carbon Dioxide Laser Therapy is an ablative therapy where abnormal collagen in scarred tissue is destroyed to permit the formation of more organized collagen. Previous studies have demonstrated its efficacy in treating medical conditions (ex. hypertrophic scars) similar to Peyronies Disease. There is evidence that Fractional Carbon Dioxide Laser Therapy has the ability to target and alter the molecular pathways that are similar to the ones that lead to Peyronie's Disease.
15814909|NCT04326452|Device|bidirectional oxygenation mouthpiece|Use of our bidirectional oxygenation mouthpiece with conventional oxygen support.
15814910|NCT04326439|Drug|Cytarabine|100 mg/m²/dose every 12 hours IV Days 1-10
15814911|NCT04326439|Drug|Daunorubicin|50 mg/m²/dose IV Days 1, 3, 5
15814912|NCT04326439|Drug|Erwinase|25,000 International Units/m²/dose IM Days 2, 9
15814913|NCT04326439|Drug|Etoposide|150 mg/m²/dose IV Days 1-5
15814914|NCT04326439|Drug|Gemtuzumab ozogamicin|Administered as a single 3 mg/m2 dose of GO to be given between days 6-10 during Induction I for patients with CC genotype, in addition to ADE therapy.
15814915|NCT04326439|Procedure|Stem cell transplantation (SCT)|Transplantation of multipotent hematopoietic stem cells from bone marrow
15814916|NCT04326439|Drug|Sorafenib|200 mg/m2/dose daily, rounded to accommodate tablet size. The maximum dose will be 400 mg. Days 7 through 34.
15814917|NCT04326426|Drug|Tradipitant|Neurokinin-1 antagonist
15814918|NCT04326426|Drug|Placebo|Matching placebo
15814919|NCT04326413|Procedure|Oral hygiene instruction and simple scaling|Monitor the changes of gum condition
15814920|NCT04326387|Diagnostic Test|SAMBA II (Diagnostic for the Real World)|Point of care Isothermal-PCR Viral RNA Amplication for virus detection
15814921|NCT04326387|Diagnostic Test|Public Health England Gold Standard|Reverse Transcription PCR
15814922|NCT04326387|Diagnostic Test|Cambridge Validated Viral Detection Method|Reverse Transcription PCR
15814923|NCT04326387|Diagnostic Test|Radiological Detection|Chest X-ray & CT Scan detection of viral infection in the lungs
15814924|NCT04326374|Drug|TransCon hGH|Once weekly subcutaneous injection
15814925|NCT04326374|Drug|daily hGH|Once daily subcutaneous injection
15814926|NCT04326361|Procedure|Neonatal surgeries|Current practices of neonatal surgeries in India
15814927|NCT04326348|Drug|TQ05105|TQ05105 is a JAK2 inhibitor.
15814928|NCT04326335|Other|Felt-tip marking|Marking the location of the future stoma with a felt pen
15814929|NCT04326335|Other|Felt-tip marking + 3D printed ostomy button|Marking the location of the future stoma with a felt pen + 3D printed ostomy button placed on the future stoma location
15814930|NCT04326322|Dietary Supplement|Methionine Intake|Intakes will be randomly chosen from a list of 7 doses of methionine. Each intake will will be repeated approximately 5 times.
15814931|NCT04326296|Drug|PD-L1 Monoclonal Antibody Combined With Lenalidomide|PD-L1 monoclonal antibody was administered by intravenous drip every 3 weeks.Lenalidomide was administered orally, 25mg once a day on days 1-21 of each repeat cycle of 28 days.
15814932|NCT04326283|Drug|Trametinib (0.5 mg)|0.5 mg/day
15814933|NCT04326283|Drug|Trametinib (1 mg)|1 mg/day
15814934|NCT04326283|Drug|Trametinib (2 mg)|2 mg/day
15814935|NCT04326283|Drug|Riluzole (100 mg)|100 mg/day (50 mg twice)
15814936|NCT04326270|Device|Nasal interface|Randomized to initial interface of nCPAP prongs or infant cannula
15814937|NCT04326257|Drug|Nivolumab+Relatlimab|IV administration of both Nivolumab and Relatlimab
15814939|NCT04326244|Diagnostic Test|blood test|High-density lipoprotein- cholesterol, Low-density lipoprotein- cholesterol, Total cholesterol, Triglyceride, Leptin, Glucose AC, Hemoglobin A1C, Insulin
15814940|NCT04326244|Diagnostic Test|genetic test|FTO、MC4R、BDNF、PPARG、ADRB3、UCP1
15814941|NCT04326244|Diagnostic Test|Constitution in Chinese Medicine Questionnaire|Constitution in Chinese Medicine Questionnaire
15814942|NCT04326244|Diagnostic Test|Epworth Sleepiness Scale|Epworth Sleepiness Scale
15814943|NCT04326244|Diagnostic Test|cephalometry|Evaluation of craniofacial morphology in OSA patients
15814944|NCT04326244|Diagnostic Test|polysomnography|to evaluate Apnea-Hypopnea Index (AHI) for the severity of sleep apnea
15814945|NCT04326231|Device|Usability assessment of Cognoa ASD Therapeutic Device|Usability assessment of Cognoa ASD Therapeutic Device
15814946|NCT04326218|Other|Blood sample|"Serum samples will be sent for centralised analyses in Nice.
~On these samples, different analysis will be performed :
~anti-PLA2R1 and anti-THSD7A antibodies
~anti-PLA2R1 and anti-THSD7A epitopes
~HLA typing"
15814947|NCT04326205|Device|transcranial direct current stimulation, tDCS|"The participants will receive a-tDCS over the ipsilesional M1, without any active arm practice for 20 minutes.
~Hence, movement extension will be achieved in the affected side while the participant will view the reflection of the normal movement patterns of their unaffected UE. Then the electrodes will be removed, and the participants will receive an additional 20 minutes of MT without tDCS followed by 30 minutes of functional task practice."
15814948|NCT04326205|Device|functional electrical stimulation, FES|"The participants will start the FES-assisted MT. During this period, participants will perform simple wrist or finger extension with their unaffected UE while the affected wrist or fingers will receive FES within the mirror-box.
~Hence, movement extension will be achieved in the affected side while the participant will view the reflection of the normal movement patterns of their unaffected UE. Then the electrodes will be removed, and the participants will receive an additional 20 minutes of MT without FES followed by 30 minutes of functional task practice."
15814949|NCT04326205|Other|no stimulation|Both tDCS and FES will not be used in this section.
15814950|NCT04326192|Device|Research electrode|A second electrode will be placed percutaneously by Tuohy needle in the epidural space at the same time as the SCS trial implant; at lateral T1-2 area randomly assigned to the left or right side of the lateral epidural space, at the time of the procedure. Placement of electrodes is not experimental, but the placement of a second electrode is a research-driven procedure.
15814951|NCT04326166|Drug|Evogliptin|Evogliptin
15814952|NCT04326166|Drug|Evogliptin|Evogliptin
15814953|NCT04326166|Drug|Metformin and Evogliptin|Metformin and Evogliptin
15814954|NCT04326153|Drug|Sintilimab Injection|"Preoperative:
~Sintilimab: 200mg QD, one cycle every 21 days, the first day of each cycle, a total of two cycles.
~Albumin paclitaxel: 135mg / m2 QD, 1 cycle every 21 days, 1 day and 8 days of each cycle, 2 cycles in total.
~Carboplatin: AUC 5mg QD, one cycle every 21 days, two cycles in total
~Postoperative:
~Patients began to receive postoperative adjuvant treatment within 21-60 days after the operation. Specific medication plan:
~Sintilimab: 200mg QD, one cycle every 21 days, the first day of each cycle, a total of 8 cycles.
~Albumin paclitaxel: 135mg / m2 QD, 1 cycle every 21 days, 1 day and 8 days of each cycle, 2 cycles in total.
~Carboplatin: AUC 5mg QD, one cycle every 21 days, two cycles in total."
15814955|NCT04326140|Device|mirror therapy|The affected side wears the machine, assists by the machine, and performs the same action with the good hand. According to the posture condition, selects two suitable actions in the three actions (all fingers open, all fingers close, all fingers open and close). The action is 10 minutes each.
15814956|NCT04326140|Device|robotic-assisted training|The hand brace is worn on the dorsal side of the impaired hand with 2 surface sensors attached to the extensor and flexor muscles of the arm to detect the surface electromyographic signals (sEMG) for active participation during exercise. The sEMG signals are processed so the patient can visualise the active movement of the muscle where sEMG electrodes are positioned. Different training modes allow the therapist to customise the level of assistance that the Hand of Hope provides. The difficulty level of each mode can be adjusted according to the patient's need.
15814957|NCT04326140|Device|sham mirror therapy|The mirror was masked. The intervention was the same as the mirror therapy.
15814958|NCT04326127|Device|Intervention is the validation of a sleep monitoring device (i.e. Somfit) against the gold-standard polysomnograph with electroencephalograph (i.e. the Greal system)|Data were recorded overnight by both devices simultaneously
15814959|NCT04326114|Device|Inspiratory training device|Inspiratory training by a Power-breath device
15814960|NCT04326114|Device|Expiratory training device|Expiratory training a Winner-flow device
15814961|NCT04326101|Other|Transmission of adherence records|Electronic transmission of patient adherence records by pharmacists into medical EHR (Electronic Health Records)
15814962|NCT04326088|Other|Reconstruction group|Patients with primary tumor which underwent free flap reconstruction group.
15814963|NCT04326088|Other|Recurrent group|Patients with recurrent tumor which underwent free flap reconstruction group.
15814964|NCT04326075|Device|CPAP treatment|CPAP should be performed as soon as possible and only with a helmet, using a positive end-expiratory pressure (PEEP) between 8 and 14 cmH2O and an inspired oxygen fraction (FiO2) between 40 and 60%.
15814965|NCT04326062|Other|Main Study|The pharmacist will participate in the management of repeat prescribing and undertake medication reviews (which will address high risk prescribing and potentially inappropriate prescribing, deprescribing and cost-effective and generic prescribing) with adult patients. Pharmacists will also provide prescribing advice regarding the use of preferred drugs, undertake clinical audits, join practice team meetings and facilitate practice-based education. Throughout the six-month intervention period, anonymised practice-level medication (e.g. medication changes) and cost data will be collected.
15814966|NCT04326062|Other|PROM Study|For this, a sub-set of patients (n=200) aged ≥65 years on ≥10 repeat medicines will be recruited and invited to a medication review with the pharmacist. PROMs and healthcare utilisation data will be collected using patient questionnaires and a six-week follow-up review with these patients will also be conducted.
15814967|NCT04326049|Device|LLETZ with videocolposcope|Loop procedure using a videocolposcope in order to see and remove the abnormal cervical tissue
15814968|NCT04326049|Device|LLETZ with binocular colposcope|Loop procedure using a binocular colposcope in order to see and remove the abnormal cervical tissue
15814969|NCT04326036|Procedure|Microcannula Harvest Adipose Derived tissue stromal vascular fraction (tSVF)|Use of Disposable Microcannula Closed System (Tulip Med, 2.2 mm) Harvest of Autologous Adipose Stroma and Stem/Stromal Cell Content
15814970|NCT04326036|Device|Centricyte 1000|Centricyte 1000 (Healeon Medical) Digestive (sterile Roche Liberase TM) Isolation/Concentration Protocol, Rinsing/Neutralization, and Pelletize the cSVF For Deployment Via Sterile Saline IV fluid Standard Protocol
15814971|NCT04326036|Procedure|IV Deployment Of cSVF In Sterile Normal Saline IV Solution|Sterile Normal Saline Suspension cSVF in 250cc for Intravenous Delivery Including Use of 150 micron in-line filtration
15814972|NCT04326036|Drug|Liberase Enzyme (Roche)|Sterile Collagenase Blend to separate cSVF from the AD-SVF
15814973|NCT04326036|Drug|Sterile Normal Saline for Intravenous Use|Sterile Normal Saline IV solution to provide suspension of cSVF in 250 cc via standard IV line, including sterile 150 micron in-line standard filter
15814974|NCT04326023|Drug|PARP Inhibitors|olaparib, rucaparib, niraparib, talazoparib, veliparib
15814975|NCT04326010|Device|Surgery|THA surgery
15814976|NCT04325997|Device|laryngoscope with mouth opener|Double-lumen tube combined with mouth gag for laryngoscope intubation
15814977|NCT04325997|Device|video laryngoscope with mouth opener|Double-lumen tube combined with mouth gag for video laryngoscope intubation
15814978|NCT04325984|Drug|Dexamethasone|To the Dexamethasone group, at the moment of the induction of anaesthesia, dexamethasone 8 mg is administered.
15814979|NCT04325971|Other|Neuroimaging|MR, EEG recordings
15814980|NCT04325958|Drug|Cannabis|750mg cigarette of plant material
15814981|NCT04325958|Drug|Placebos|750mg cigarette of plant material
15814982|NCT04325945|Device|Low level laser therapy|808nm low level laser therapy on acupuncture points
15814983|NCT04325932|Drug|Urinary Kallikrein|
15814984|NCT04325919|Other|No intervention|No intervention
15814985|NCT04325906|Device|high flow nasal cannula (HFNC)|HFNC will be initiated at 50 L/min (AIRVO2 or Optiflow, Fisher &Paykel Health care Limited., Auckland, New Zealand) with temperature set at 37 oC. Nasal cannula size will be determined by the patient's nostril size (≤ 50%). FIO2 will be adjusted to maintain SpO2 at 92% to 95%. Flow and temperature will be adjusted based on patient's comfort and clinical response.
15814986|NCT04325906|Procedure|Prone positioning (PP)|PP will be performed before or 1 hour after meal. Before PP, all the I.V. lines and nasal cannula will be checked by clinicians. PP will be performed by patient under the supervision of clinicians. Assistance will be offered if needed. If tolerated, PP will be maintained for at least 30 minutes, until the patients feel tired to keep that position. PP will be performed twice a day for the first 3 days after the patient's enrollment. FIO2 will be adjusted to maintain SpO2 at 92-95%.
15814987|NCT04325893|Drug|Hydroxychloroquine|First dose of 400 mg will be taken immediately after inclusion at day 0, the second dose of 400 mg will be taken on the same evening and at least 4 hours after the first dose. The treatment will then be continued for the following eight days at a rate of 200 mg in the morning and evening.
15814988|NCT04325893|Drug|Placebo|TFirst dose of 400 mg will be taken immediately after inclusion at day 0, the second dose of 400 mg will be taken on the same evening and at least 4 hours after the first dose. The treatment will then be continued for the following eight days at a rate of 200 mg in the morning and evening.
15814989|NCT04325880|Drug|Mirabegron 50 MG|Patients in this arm will receive Mirabegrone 50 MG once daily
15814990|NCT04325880|Drug|Tamsulosin|Patients in this arm will receive Tamsulosin o.4 MG once daily
15814991|NCT04325880|Drug|Solifenacin Succinate 10 MG|Patients in this arm will receive Solifenacin Succinate 10 MG once daily
15814992|NCT04325880|Drug|Placebo oral tablet|Patients in this arm will receive placebo oral tablet once daily
15814993|NCT04325867|Other|Tele-medicine platform|Electronic counselling of known pathology cardiovascular patients through a complex remote platform and dedicated experts. This project intend remote monitoring through wearable devices (e.g. ECG watches, pulse detectors, oximetry).
15814994|NCT04325854|Procedure|I and II level ART procedure|I level: Intrauterine insemination II level: Invitro fertilization technique; Intracytoplasmic sperm injection; Embryo transfer
15814995|NCT04325841|Biological|Murine autologous anti-CD19 chimeric antigen receptor T cells|CAR-T cells were manufactured from peripheral blood mononuclear cells collected by leukapheresis and frozen for multiple uses. Before each CAR T-cell infusion (day 0), patients received lymphodepleting chemotherapy composing of Fludarabine (30 mg/m2/day) and Cyclophosphamide (250 mg/m2/day) on days -5 to -3. No bridging chemotherapy was given between enrollment and infusion. In CD19 T cell clinical trials, CAR-T cells was given once. All patients underwent bone marrow (BM) biopsy examination and radiology studies on days 30 and every month to determine the response and remission status. Bone biopsy, MRD status by FCM and RT-PCR (if the patient had fusion gene), and EMDs evaluation by CT/MRI/PET-CT were also conducted before CAR-T cell infusion to determine the disease status.
15814996|NCT04325828|Drug|Apalutamide|Apalutamide 240 mg (4*60-mg tablets) will be administered orally once daily with or without food.
15814997|NCT04325828|Drug|GnRH Agonist|A stable regimen of goserelin 3.6 mg will be administered as a GnRH agonist.
15814998|NCT04325815|Device|CADDIE- Computer Aided (AI) Device used in Endoscopy|"CADDIE assisted polyp detection
~CADDIE assisted polyp characterisation"
15814999|NCT04325802|Drug|Naltrexone|50mg Naltrexone daily
15815000|NCT04325802|Other|Placebo|Placebo (Mannitol) daily
15815002|NCT04325776|Drug|AL2846|AL2846 is a multi-target tyrosine kinase receptor inhibitor with obvious selective to c-met.
15815003|NCT04325776|Drug|Zoledronic Acid Injection|Zoledronic acid is a bisphosphonate drug that has a strong inhibition of bone resorption and a potential to promote bone formation, and can be used for bone metastasis caused by malignant tumors.
15815004|NCT04325763|Drug|TQB2450|TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
15815006|NCT04325763|Drug|TQB2450(blank)|Subjects administrated TQB2450 (blank) intravenously (IV) on Day 1 of each 21-day
15815007|NCT04325763|Drug|Anlotinib(blank)|Subjects administrated anlotinib (blank) in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)
15815008|NCT04325750|Procedure|TECAR Therapy|The intervention will be performed with the T-Care TECAR® therapy machine at the latent trigger points of both gastrocnemius. The professional will apply the therapy with the generator that emits radio frequency signals of 0.5 MHz at a variable power with a maximum of 300W. The frequency to be used will be 500MHz with an intensity of 40% and with direct current.
15815009|NCT04325750|Other|Placebo|simulated TECAR Therapy (machine off)
15815010|NCT04325737|Drug|SEP-363856|Dosing of the SEP-363856 group in Cohort 1 will be initiated at 50 mg SEP-363856 as an oral once daily dose for 3 consecutive days, followed by 75 mg SEP-363856 as an oral once daily dose for 4 consecutive days, and followed by 100 mg SEP-363856 as an oral once daily dose for 7 consecutive days. The SEP-363856 group in Cohort 2 will be dosed at 25 mg SEP-363856 as an oral once daily dose for 3 consecutive days, followed by 50 mg SEP-363856 as an oral once daily dose for 3 consecutive days, followed by 75 mg SEP-363856 as an oral once daily dose for 4 consecutive days, and followed by 100 mg SEP-363856 as an oral once daily dose for 7 consecutive days.
15815011|NCT04325737|Drug|Placebo|Placebo will be orally administered according to the same administration schedule as the SEP-363856 group in each cohort.
15815012|NCT04325724|Other|General evaluation|Demographic characteristic, psoriasis duration, disease duration, treatments
15815013|NCT04325724|Other|Dermatological evaluation|treatment and evaluation
15815014|NCT04325724|Other|Rheumatological evaluation|joints, enthesis, tendons, and other ultrasound abnormalities
15815015|NCT04325724|Other|para clinical data|biological data, medical imaging data
15815016|NCT04325724|Other|Patient reported outcomes (PROs)|Psoriatic arthritis impact of disease 12 (PsAID12), hospital anxiety and depression scale (HAD), SF 36
15815017|NCT04325711|Drug|CSPCHA131|CSPCHA131 will be administered twice weekly in the first three weeks of a 4-week cycle.
15815018|NCT04325698|Drug|PF-06439535 (CN)|15 mg/kg, IV on day 1 of each 21 day cycle for up to 2 years, or until progression or unacceptable toxicity develops.
15815019|NCT04325698|Drug|Bevacizumab-EU|15 mg/kg, IV on day 1 of each 21 day cycle until disease progression, unacceptable toxicity or 25 weeks. At Week 25, the participants with clinical benefit will received PF-06439535 (CN) monotherapy for up to 2 years from randomization in this study
15815020|NCT04325698|Drug|Paclitaxel|175 mg/m2 via IV infusions on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles.
15815021|NCT04325698|Drug|Carboplatin|AUC 5 (max=750mg) via IV infusions on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles.
15815022|NCT04325685|Drug|Control|Oropharyngeal decontamination with saline will be performing three time a day every 8 hours during mechanical ventilation
15815023|NCT04325685|Drug|Antiseptic Solution|Oropharyngeal decontamination with antiseptic solution will be performing three time a day every 8 hours during mechanical ventilation
15815024|NCT04325685|Drug|Bacteriophage|Oropharyngeal decontamination with bacteriophage will be performing three time a day every 8 hours during mechanical ventilation
15815025|NCT04325672|Biological|Convalescent Plasma|Anti-SARS-CoV-2 convalescent plasma obtained from patients identified as having recovered from COVID-19 with neutralizing antibody titers >1:64.
15815026|NCT04325659|Device|Bridge Device|An FDA-cleared neuromodulator medical device, marketed for the treatment of opioid withdrawal
15815027|NCT04325659|Drug|Lofexidine|FDA-approved medication for the treatment of opioid withdrawal. Participants will receive capsules 4 times daily for 7 days. The active dose is 0.72 mg four times daily for Days 1-5, for a total daily dose of 2.88 mg. Doses on Days 6 and 7 will be 1.44 (2 active, 2 placebo capsules) and 0.72 mg (1 active, 3 placebo capsules), respectively.
15815028|NCT04325659|Drug|Placebo|Inactive study drug, encapsulated to look like the active study drug. Participants will receive capsules 4 times daily for 7 days.
15815029|NCT04325659|Device|Sham Bridge Device|Inactive Bridge Device which is applied and looks identical to the active Bridge Device
15815030|NCT04325646|Other|Human Biological samples|Blood samples for serological tests
15815031|NCT04325646|Other|Human Biological samples|Blood samples, saliva, nasopharyngeal swab for serological tests
15815032|NCT04325633|Drug|1: Naproxen|Description : Administration of naproxen 250 mg twice and lansoprazole 30 mg daily for prevention of gastropathy induced by stress or a nonsteroidal anti-inflammatory drug (NSAID) in addition to standard of care (SOC)
15815033|NCT04325633|Drug|2: Standard of care|Standard of care
15815034|NCT04325620|Drug|HIP1601|HIP1601
15815035|NCT04325620|Drug|HGP1805|Placebo of HIP1601
15815036|NCT04325607|Procedure|Excision of HS followed by NPWTi|The NPWTi that will be used in this study will be the V.A.C. VERAFLO™ Therapy (KCI)
15815037|NCT04325607|Procedure|Excision of HS followed by NPWT|The NPWT that will be used in this study will be the V.A.C.® Therapy(KCI)
15815038|NCT04325594|Procedure|Cardiac catheterization|Catheterization of the right and left heart cavities
15815039|NCT04325594|Biological|Intracoronary administration of the umbilical cord-derived mesenchymal stromal cells|After performing cardiac catheterization, selective coronary angiography will be performed abruptly to assess the condition of the coronary canal by access through the right radial or common femoral artery on the right after 70 U/kg of heparin iv. Then 20 ml of the finished suspension (1×10(7) umbilical cord-derived mesenchymal stromal cells diluted in 20 ml of heparinized saline) will be administrated into the mouth of the left coronary artery (LCA) without occlusion of the vessel with a balloon catheter and without stopping the coronary blood flow. Cell injection will be carried out using a standard 6 Fr catheter for selective coronary angiography with perfusion for 10 minutes at a volume rate of 2 ml/min, thereby introducing 1×10(6) cells per minute
15815040|NCT04325581|Drug|Liraglutide 6 MG/ML|Liraglutide in incremental dose upto maximum of 1.8 mg per day SC daily
15815041|NCT04325581|Drug|Placebos|Normal Saline SC daily
15815042|NCT04325568|Behavioral|PsyGist and Clinician Manual|This is a pre-post test design aimed at conveying future genetic risk information to those at clinical high risk for psychosis. Participants will be assigned to either complete the Clinician Manual intervention (n= 27 participants) or PsyGist intervention (n=27 participants).
15815043|NCT04325555|Drug|PrEP|The investigators measure self-reported PrEP status as exposure, i.e., PrEP status is not confirmed via matched medical records or any other type of information directly collected form subjects.
15815044|NCT04325542|Diagnostic Test|HBSAg (sure screen test)|Diagnostic test for Hepatitis B
15815045|NCT04325529|Device|Aversive stimuli|Electrotactile stimulation will be used as the aversive stimulus. The aversive stimulus is delivered in the form of a mild half-second stimulation to the ankle, calibrated to a subjective threshold that is uncomfortable but not painful. This stimulation is delivered by Digitimer DS8R Constant Current Stimulator (Digitimer North America, LLC. Ft. Lauderdale, FL). Its previous model DS71 has been safely implemented in studies with previously MGH-approved IRB's (Milad et al., 2013).
15815046|NCT04325516|Behavioral|Daily activities|"Participants will perform four tasks in a randomized order:
~sit to stand
~dorsi flexion of the foot
~knee extension
~hip extension"
15815047|NCT04325503|Drug|carbidopa|carbidopa and carbidopa-levodopa standard treatment
15815048|NCT04325490|Drug|Liquid powder|apply the study drug 1 fingertip unit to cover intertrigo lesion twice a day for two weeks.
15815049|NCT04325490|Drug|Hydrocortisone cream 1%|apply the study drug 1 fingertip unit to cover intertrigo lesion twice a day for two weeks.
15815050|NCT04325477|Device|Nolix Device|The Nolix device is a single use, dynamic, and soft flexible intra-vaginal device for temporary management of SUI
15815051|NCT04325464|Device|PEAR-003A|PEAR-003A delivers CBT-I through a decentralized clinical trial open to participants with chronic insomnia
15815052|NCT04325438|Other|Pharmaceutical Care|"Pharmaceutical care interventions are categorised into 2 aspects:
~Pharmacists' expertise aspect: medications review, identification and solution for the drug-related problem, adverse events, and other medication-related clinical problems. Therapeutic drug monitoring (TDM) is performed for any dose adjustment to the Rifampicin.
~Motivational behavioral intervention to improve medication adherence (i.e. medications information and counseling to study participants)."
15815053|NCT04325425|Drug|FOLFOXIRI Protocol|Platinum-Etoposide regimen will be administered once every 21 days. Treatment will be continued for 6 to 8 cycles or 24 weeks maximum. One cycle consists of 21 days (3 weeks) with injection on D1 of each cycle (D1=D22). Patients are eligible for repeated treatment cycles in the absence of disease progression and undue adverse events.
15815054|NCT04325425|Drug|Cisplatin injection|"Cisplatin 100 mg/m2, IV infusion over 3 hours or Carboplatin AUC 5, IV infusion over 30 minutes on day 1 [the dose of carboplatin will be determined for each cycle using the Calvert's formula (carboplatin dose (mg) = target AUC 5 x estimated glomerular filtration rate (eGFR, mL/min) + 25)];
~• Etoposide 100 mg/m² IV infusion over 1 hour on day 1,2 and 3"
15815055|NCT04325399|Other|Volitional help sheet|
15815056|NCT04325386|Other|Education Sessions|Project ECHO (Extension for Community Healthcare Outcomes) based intervention sessions for improving the use of clozapine in people with treatment-resistant schizophrenia. The sessions will include: 1) active dissemination of knowledge and information by an expert followed by 2) clozapine case presentations and vignettes.
15815057|NCT04325386|Other|No Education Session|No Education Session
15815058|NCT04325360|Procedure|Cathodal Transcranial Direct Current Stimulation|20 minutes of cathodal stimulation at 2mA, with cathode electrode placed over the focal epileptic area (determined by EEG exam and located according to the 10-20 system), the anode electrode will be placed over the supraorbital region, contralateral to the cathode electrode.
15815059|NCT04325360|Procedure|Sham Transcranial direct current stimulation|Participants will received 20 mins of Sham stimulation, where stimulation will happen for the first 30 seconds and in the last 30 seconds of the intervention (at 2mA), with no stimulation in the between time. The cathode electrode will be placed over the focal epileptic area (determined by EEG exam and located according to the 10-20 system),the anode electrode will be placed over the supraorbital region, contralateral to the cathode electrode.
15815060|NCT04325347|Other|Virtual Reality application|Virtual Reality application with a VR goggle
15815061|NCT04325334|Behavioral|Running volume increase|"Participants will receive a 12-week running program to increase their running volume by approximately 10% per week on average, and in accordance with the 10% rule advocated to minimize injury rates. For the purpose of this study, participants will run using their habitual technique - i.e. no specific instructions on 'how' to run will be provided; rather, they will simply be instructed on 'how much' to run."
15815062|NCT04325321|Other|Stress reactivity test|"The protocol consists of Resting Baseline (BL), Emotion Recall (ER), followed by a Recovery Phase (RP). Heart rate and blood pressure are measured at baseline and then every 5 minutes during ER and RP.
~Resting Baseline (BL - 10 min). The participant is instructed to rest quietly.
~Emotion Recall (ER - 5-10 min). The participant is instructed to think about the incident associated with the onset of their cardiac event and bring to mind details of the incident. When the participants have the incident clearly in mind, they are instructed to relate the incident and their experience out loud; frequent questions to re-elicit the emotion are asked.
~Recovery Phase (RP - 20 min). Upon completion of RP, the catheter is removed and participants are de-instrumented. Blood samples for plasma catecholamines, assessments of heart rate variability, and echocardiograms are performed 10-min into BL, 10-min into ER, and 18 minutes into RP."
15815063|NCT04325308|Procedure|Protein-enriched human milk diet|1.2 g of human-based protein will be added to each 100 ml of human milk administered
15815064|NCT04325308|Procedure|Usual human milk diet|Human-based protein will not be added to the human milk administered.
15815065|NCT04325295|Procedure|Laparoscopic ovarian drilling|LOD will be done in the follicular phase.Follow up will be done on the next cycle by performing a TVUS examination at CD 13 and measuring the dominant follicles. Ovulation is considered if a follicle reached > 17 mm and is confirmed by measuring serum progesterone at CD 21.If ovulation is not achieved in the cycle following LOD, women will be prescribed Letrozole by the dose of 2.5 mg daily for 5 days starting from CD 3, and ovulation monitoring will be done similarly. If ovulation is not achieved, the dose is increased by 2.5 mg daily in the subsequent cycle until reaching the maximum dose of 7.5 mg daily for a total of 3 cycles.With persistent resistance to Letrozole in inducing ovulation, Gn will be prescribed for 3 cycles as in Gonadotrophin strategy
15815119|NCT04324840|Drug|CC-90010|CC-90010 (e.g., 15 mg, 30 mg and 45 mg) will be given orally once daily (4 days on/24 days off) in combination with TMZ+RT for 42 days, to evaluate the initial toxicity of the combination. Following completion of 42 days of Concomitant Therapy, subjects who are fit to continue treatment will have a 4-week break before starting adjuvant therapy with CC-90010 in combination with TMZ.
15815066|NCT04325295|Drug|Recombinant FSH (rFSH)|A low-dose step-up protocol will be implemented. This starts on CD 3,The rFSH will be given through (IM) or(SC) injections with 75 IU and will be given once daily.Monitoring of the treatment will be done on CD 7 by TVUS and serum E2. Monitoring is individualized according to the response. Depending on the response and follicular growth, the dose may be adjusted by increasing 37.5 IU. If follicular growth failed, the dose is furtherly increased by the same amount until at least one follicle reaches 10 mm. The dose is maintained until at least one follicle reaches a diameter of 18 mm and no more than 2 follicles are bigger than 15 mm. Once reaching the desired diameter, the rFSH will be stopped and a trigger of ovulation by an IM injection of 5000 IU of hCG and sexual intercourse is encouraged on the day of trigger and the next day. Then serum P will be done 7 days after hCG injection to detect the occurrence of ovulation.
15815067|NCT04325282|Device|Active rTMS|1Hz rTMS delivered for 15-20 minutes
15815068|NCT04325282|Device|Sham rTMS|sham rTMS delivered for 15-20 minutes
15815069|NCT04325256|Procedure|Manipal ultrasound scoring system|length of the cervix from the internal to external os, presence or absence of funneling and if present width and length of funneling at internal os were measured. Distance between presenting part to external os will be measured and position of the cervix i.e. whether curved or straight will also noted.
15815070|NCT04325256|Procedure|Levine scoring system|maternal height, parity, body-mass index (BMI) at delivery and the results of modified Bishop's score in calculation of probability of CS
15815071|NCT04325243|Drug|Sildenafil 50 mg|50 mg oral Sildenafil tablet
15815072|NCT04325243|Drug|Placebo oral tablet|placebo tablets of the same shape, color and size of Sildenafil tablets manufactured in the Department of Pharmaceuticals, Faculty of Pharmacy
15815073|NCT04325230|Device|Arterial Spin Labeling sequence|ASL sequence added to the usual care brain MRI
15815074|NCT04325217|Drug|Nintedanib|Capsules
15815075|NCT04325204|Behavioral|Faith-based Home Activity Toolbox (Faith-HAT)|"They will select activities from Faith-HAT at least 3 times a week. Possible examples of these activities include devotional readings, prayer, music, religious images, and video and audio recorded sermons.
~Faith-HAT will be placed on online, which requires little technical know-how by users. The PI will provide training to participants on how to use the Faith-HAT and online diary on the tablet computer provided by the project."
15815076|NCT04325191|Dietary Supplement|Melatonin|Daily consumption of a high sodium diet and melatonin for 10 days
15815077|NCT04325191|Other|Placebo|aily consumption of a high sodium diet and placebo for 10 days
15815078|NCT04325178|Other|Protein, calorie and macronutrient controlled diet, derived from either omnivorous or non-animal sources, alongside unilateral resistance exercise, over a three-day period.|Participants received a control diet either derived from omnivorous or non-animal food sources, providing 1.8g.kg.day of protein, for a three-day period. Calories were calculated and set to place participants in a state of energy balance. Participants completed three bouts of unilateral resistance exercise, 5 sets of 30 maximal concentric knee extension contractions, on each morning that they received the control diet. During this three-day period participants also consumed a deuterium oxide tracer allowing for the measurement of muscle protein synthesis, in rested and exercised tissue, with incremental biopsies.
15815079|NCT04325165|Device|DBS Implantation|Bilateral implantation of PPN DBS electrodes
15815080|NCT04325152|Device|FCSEMS plus Clip|After successful cannulation, a 10mm FCSEMS with the length of 6cm or 8cm were inserted into CBD. Then a metal clip was used to fix the distal end of FCSEMS with the duodenal mucosa adjacent to papilla.
15815081|NCT04325152|Device|FCSEMS|FCSEMS was released as the same as mentioned above. No fixating method was used.
15815082|NCT04325139|Other|Questionnaire|Before colonoscopy, the following information was obtained by the colonoscopists through asking patients: the characteristics of last stool, the time of drinking first dose of laxative, the time of first defecation, the time of drinking last dose of laxative. The beginning time of colonoscopy was also recorded. During withdrawal phase, the quality of bowel preparation was evaluated based on BBPS scale.
15815083|NCT04325126|Other|Exposure factors|Exposure factors，such as diet，exercise，environment
15815084|NCT04325113|Drug|levobupivacaine|Patient satisfaction and pain score using a visual anagogic scale (VAS)
15815085|NCT04325100|Behavioral|Switch - Individual sessions|"Participants follow the Switch intervention through individual sessions (1 hour, twice a week, for around 2 months).
~Participants are provided with a folder which presents the rational for each strategy. Take-home assignments are given and stored in the same folder. Participants are also given small cards (that can fit in their wallet) containing the key elements of each strategy.
~The intervention manual can be obtained from the main investigator (in French)."
15815086|NCT04325100|Behavioral|Switch - Group programme|"Participants follow the Switch group programme (2 hours, twice a week, for around 2 months).
~During the group sessions, a powerpoint presentation and different media are used to present the different parts of the motivation model. Participants learn the different strategies (e.g., cognitive defusion, pleasure anticipation, problem solving) through individual and group exercises.
~Participants are provided with a folder which presents the rational for each strategy. Take-home assignments are given and stored in the same folder. Participants are also given small cards (that can fit in their wallet) containing the key elements of each strategy.
~The intervention manual and the presentation material can be obtained from the main investigator (in French)."
15815087|NCT04325087|Device|iTBS|Administration of an iTBS protocol over the dlPFC
15815088|NCT04325087|Device|Placebo iTBS|Administration of a placebo TMS protocol over the dlPFC
15815089|NCT04325074|Other|Mental practice|During each of the 12 treatment sessions, the patient was asked to select two tasks from a list of MP activities, graded by level. Once the task was selected, patients received the specific visual or audio instructions and subsequently performed the task. The recording was viewed three times and the audio instructions were repeated two times. To listen to the audio instructions, the participants were requested to close their eyes in order to aid concentration. After listening to the recordings, the patient was asked to perform the task once again, practicing what had been learnt. After the process was completed, the participant completed a questionnaire and scored each task.
15815120|NCT04324840|Drug|Temozolomide|TMZ will be given orally at the standard dose of 75 mg/m2 per day for 7 days per week from the first day of radiotherapy until the last day of radiotherapy for 42 days. Following completion of 42 days of Concomitant Therapy, subjects who are fit to continue treatment will have a 4-week break before starting adjuvant therapy.
15815090|NCT04325074|Other|Mental practice + skill training|In this option, six sessions of MP were alternated with six sessions of skills training (ST). The MP protocol was the same as in group A: selecting, performing, visualizing, listening to and scoring the selected tasks. The activities performed in the skills training were based on the Kamm et al. (2015) protocol and bimanual tasks. After the performance of each task, the patients were allowed to rest for 1 or 2 minutes to avoid the appearance of fatigue.
15815091|NCT04325074|Other|Control group|The control group only received their usual physical therapy and occupational therapy treatments provided by their association. The treatment mainly consisted of the application of the Bobath concept and the Vojta method, dry needling, myofascial induction therapy, passive mobilizations, training of gross and fine motor coordination of the upper limbs, resistance training and static and dynamic balance training.
15815092|NCT04325061|Drug|Dexamethasone|Dexamethasone (20 mg/iv/daily/from Day 1 of randomization during 5 days, followed by 10 mg/iv/daily from Day 6 to 10 of randomization
15815093|NCT04325048|Device|Cordio App|Adult patients positive to COVID-19 virus will record several predefined sentences via a smartphone / tablet and will answer questions via the app
15815094|NCT04325035|Drug|Istaroxime|Reconstituted istaroxime and lactose lyophilized powder delivered via IV infusion
15815095|NCT04325035|Drug|Placebo|Reconstituted placebo (lactose lyophilized powder) delivered via IV infusion
15815096|NCT04325022|Device|Primary Total Hip Arthroplasty|Primary Total Hip Arthroplasty using the OR3O Dual Mobility System in combination with compatible components
15815097|NCT04325022|Device|Revision Total Hip Arthroplasty|Revision Total Hip Arthroplasty using the OR3O Dual Mobility System in combination with compatible components
15815098|NCT04325009|Drug|Lipitor 80mg Tab → Dong-A Atorvastatin 80mg Tab|"st period: single oral administration of 1 tablet of Lipitor 80mg Tab washout period: 7days
~nd period: single oral administration of 1 tablet of Dong-A Atorvastatin 80mg Tab washout period: 7days
~rd period: single oral administration of 1 tablet of Lipitor 80mg Tab washout period: 7days
~th period: single oral administration of 1 tablet of Dong-A Atorvastatin 80mg Tab"
15815099|NCT04325009|Drug|Dong-A Atorvastatin 80mg Tab → Lipitor 80mg Tab|"st period: single oral administration of 1 tablet of Dong-A Atorvastatin 80mg Tab washout period: 7days
~nd period: single oral administration of 1 tablet of Lipitor 80mg Tab washout period: 7days
~rd period: single oral administration of 1 tablet of Dong-A Atorvastatin 80mg Tab washout period: 7days
~th period: single oral administration of 1 tablet of Lipitor 80mg Tab"
15815100|NCT04324996|Biological|NK cells,IL15-NK cells,NKG2D CAR-NK cells,ACE2 CAR-NK cells,NKG2D-ACE2 CAR-NK cells|The CAR-NK cells are universal off the shelf NK cells enriched from umbilical cord blood and engineered genetically.
15815101|NCT04324983|Other|Blood sample|"Additional blood sample of about 30 ml that will be drawn for biomarker analyses (2 EDTA = ethylenediaminetetraacetic acid and 1 Cell-search-tubes).The drawn blood for CTC-Analysis and biomarker identification will be promptly processed ac-cording to the established standards at the Institute for Tumor Biology (see below).
~The histological analysis of the resected tissue during salvage surgery is carried out according to clinical routine (conventional haematoxylin and eosin stained and PSMA-Immunohistochemistry). Additionally, tissue samples will undergo molecularpathological analysis if this does not affect routine pathological examination."
15815102|NCT04324970|Device|Tookie Vest|Tookie Vest
15815103|NCT04324957|Other|Neonatal cardio-pulmonary outcome measure used to assess cardio-pulmonary status|Neonatal cardio-pulmonary outcome measure will be used to assess overall status of pulmonaryand cardio-vascular system
15815104|NCT04324944|Behavioral|Collaborative Decision Skills Training|An eight-session group-based skills training intervention that focuses on treatment-related decision-making in order to facilitate improved engagement in decision-making processes. CDST teaches assertiveness skills, problem solving, goal planning, and conflict negotiation, within the context of treatment planning and decision-making. Each session is 60 minutes long.
15815105|NCT04324944|Behavioral|Money Management|An eight-session group intervention that focuses on psychoeducation around fundamental financial skills. Each session is 60 minutes long.
15815106|NCT04324931|Other|Biomechanical corrections|Biomechanical corrections is to be done to correct the varus deformity of knee joint and for pain management.
15815107|NCT04324931|Other|Conventional Physiotherapy|Conventional therapy includes Hydrocollatoral pack for 20 minutes, Interferential therapy for 15 minutes beat frequency 100 Hz, Sweep frequency 150 Hz and exercise program of 3 sessions for 20 minutes on alternative days for 3 weeks for management of knee osteoarthritis.
15815108|NCT04324918|Drug|HCP1102|The participants will receive tretment of HCP1102(combination of Montelukast + Levocetrizine), orally, once daily for 4weeks.
15815109|NCT04324918|Drug|HGP1408|The participants will receive tretment of HGP1408(Levocetrizine), orally, once daily for 4weeks.
15815110|NCT04324905|Drug|HIP1802|Test drug
15815111|NCT04324905|Drug|HGP1705|Reference drug
15815112|NCT04324892|Drug|Treat to target|All patient will received protocolized treatment with an aim to achieve SDAI remission
15815113|NCT04324879|Drug|TQ-B3525|TQ-B3525 tablet administered 20mg orally, once daily in 28-day cycle.
15815114|NCT04324866|Diagnostic Test|Nasopharyngeal swab|Nasopharyngeal swab for the molecular diagnosis of COVID-19 infection
15815115|NCT04324853|Diagnostic Test|Microscopy ( Urine filtration), UCAA test, qPCR,|Schistosomiasis is an acute and chronic parasitic disease caused by blood flukes (trematode worms) of the genus Schistosoma.Schistosomiasis is prevalent in tropical and subtropical areas, especially in poor communities without access to safe drinking water and adequate sanitation.
15815116|NCT04324853|Diagnostic Test|Microscopy (Kato Katz, Coproculture, Harada Mori, MIF), qPCR,|Soil-transmitted helminth infections are among the most common infections worldwide and affect the poorest and most deprived communities. They are transmitted by eggs present in human faeces which in turn contaminate soil in areas where sanitation is poor.
15815117|NCT04324840|Drug|CC-90010|CC-90010 (eg.dose levels 15mg, 30mg, 45 mg) will be given once daily by mouth 4 days on/24 days off every 28-day cycle for 6 cycles. If subjects complete this period with no evidence of disease progression per RANO criteria, subject might receive CC-90010 as monotherapy at RP2D of 45 mg given 4 days on/24 days off in each 28-day cycle, until stopping criteria are met.
15815118|NCT04324840|Drug|Temozolomide|Temozolomide
15815121|NCT04324827|Device|Graston Technique|FR is a dense foam cylinder that the person rolls before using the body weight to warm up and increase their ROM. There are different types that vary in size, shape and density.
15815122|NCT04324827|Other|Dynamic stretch exercise|Dynamic stretch includes controlled movements in the active ROM for a joint. This type of exercise is actually the basis of sports movements used in training or competition.
15815124|NCT04324801|Other|Homeostatic plasticity induction using transcranial direct current stimulation|Homeostatic plasticity will be induced in the left primary motor cortex using tDCS applied for 7 minutes followed by an interval of 3 minutes and another block of 5 minutes of stimulation
15815125|NCT04324788|Other|Group 1|The patients will be asked to go up and down 9-step stair with the highest speed they can make.
15815126|NCT04324788|Other|Group 2|The patients will be asked to go up and down 9-step stair with the highest speed they can make.
15815127|NCT04324775|Other|Exercise + Manual Lymphatic Drainage|Quadriceps exercises with weight of 75%1 Max repetition and 8 repetionX3 sets Following exercises, manual lymphatic drainage applied to rectus femoris for 5 minutes
15815128|NCT04324775|Other|Exercise + Swedish massage|Quadriceps exercises with weight of 75%1 Max repetition and 8 repetionX3 sets Following exercises, swedish massage applied to rectus femoris for 5 minutes
15815129|NCT04324762|Behavioral|targetted implementation strategies|strategies at the individual and institutional level to promote implementation of an evidenced based innovation and de-implementation of an unnecessary, low value diagnostic test.
15815130|NCT04324749|Other|Roasted peanuts (group A)|After 2 weeks following a peanut-free diet, the participants of this group consume 25 g/ day of whole skin roasted peanuts (RP) within the habitual diet during 6 months.
15815131|NCT04324749|Other|Peanut butter (group B)|After 2 weeks following a peanut-free diet, the participants of this group consume 2 tbsp/ day (32 g/ day) of peanut butter (PB) within the habitual diet during 6 months.
15815132|NCT04324749|Other|Control (group C)|After 2 weeks following a peanut-free diet, the participants of this group consume 2 tbsp/ day (32 g/ day) of control supplement (containing the same proportion of macronutrients as peanuts and peanut butter) within the habitual diet during 6 months.
15815133|NCT04324736|Other|no interventional study|no interventional study
15815134|NCT04324723|Behavioral|WhatsApp message|"The experimentally evaluated part of the intervention is a WhatsApp message.
~The message translated from Arabic to English appears below. Dear [First name], Your BP reading during Beirut Marathon was [reading]. This indicates that you have elevated blood pressure. You should seek medical attention at your earliest convenience. Your wellbeing matters to us. Nudge Lebanon team"
15815135|NCT04324697|Procedure|Horizontal alveolar bone augmentation|Horizontal augmentation in anterior maxilla using allograft shell and autogenous chips with no need for a second surgical site
15815136|NCT04324671|Device|nasofibroscopy|"Flexible videorhinolaryngoscope, PAL 11101VP*, 4.2 mm diameter. Using a computerized system including:
~Light source: Explor ENT (HAL250). The software allowed audio, video recording and retrieval of recorded material."
15815137|NCT04324658|Device|Lactiplus|capsules containing L. gasseri LA806
15815138|NCT04324645|Other|Noona Software|Enrolled patients will be provided with login information for their Noona account. Patients will log in to the Noona symptom monitoring system using their own computer hardware. Any type of personal computer or compatible mobile device will be allowed (i.e. iPhone, Android phone). Patients will be able to access the Noona system from any internet access point and will be provided with the hospital/clinic public WiFi information.
15815139|NCT04324619|Other|Online interactive learning activities|"3-hour video-storyline-based interactive learning program
~Micro-learning activities that can be completed on mobile devices (eg, smartphones)"
15815140|NCT04324606|Biological|ChAdOx1 nCoV-19|A single dose of 5x10^10vp of ChAdOx1 nCoV-19
15815141|NCT04324606|Biological|MenACWY|Standard single dose of MenACWY vaccine delivered intramuscularly
15815142|NCT04324606|Biological|ChAdOx1 nCoV-19 full boost|A single dose of 5x10^10vp of ChAdOx1 nCoV-19 followed by a boost dose of 5x10^10vp of ChAdOx1 nCoV-19
15815143|NCT04324606|Biological|ChAdOx1 nCoV-19 half boost|A single dose of 5x10^10vp of ChAdOx1 nCoV-19 followed by a boost dose of 2.5x10^10vp of ChAdOx1 nCoV-19
15815144|NCT04324606|Biological|MenACWY boost|A standard dose of MenACWY followed by a boost dose of MenACWY
15815145|NCT04324606|Drug|Paracetamol|1g every 6 hours for 24 hours
15815146|NCT04324606|Biological|ChAdOx1 nCoV-19 0.5mL boost|A single dose of 5x10^10vp of ChAdOx1 nCoV-19 followed by a boost dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10^10vp)
15815147|NCT04324606|Biological|ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10^10vp) late vaccine (LV)|A dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10^10vp) 9 months after receiving a single or double dose of 5x10^10vp of ChAdOx1 nCoV-19
15815148|NCT04324606|Biological|ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10^10vp) late vaccine two (LVT)|A dose of ChAdOx1 nCoV-19 0.5mL (3.5-6.5x10^10vp) 9 months after receiving a single or double dose of MenACWY, then a boost 4-12 weeks later
15815149|NCT04324593|Device|Peripheral intravenous analysis (PIVA) algorithm|An IV line with an attached Deltran BP transducer will be used together with LabChart software to record venous waveforms during various interventions. These waveforms will be processed using the PIVA algorithm and the calculated values will be compared to those from Nellcor respiratory monitor, Capnograph and cardiac telemetry monitoring.
15815150|NCT04324580|Other|Splint|Participants will have their open reduction internal fixation of distal radius fractures treated with volar locked plating. for 2 weeks. Which will be replaced by a custom thermoplastic splint for 5 weeks.
15815151|NCT04324580|Behavioral|Formal Physical Therapy|Participants will also receive a prescription for formal physical therapy. Supervised physical therapy will be prescribed 1- 2 times per week for a total of 8 weeks along with a home exercise program. Active range of motion and strengthening exercises will be performed at home twice daily for 20 minutes for a total of 8 weeks.
15815152|NCT04324580|Behavioral|Self directed physical therapy|Participants will be given a pamphlet with detailed instructions and demonstrations in home exercises. Active range of motion and strengthening exercises will be performed twice daily for 20 minutes for a total of 8 weeks.
15815153|NCT04324580|Other|Soft dressing (No Splint)|Participants will have their open reduction internal fixation of distal radius fractures placed in a soft dressing which will be kept in place for 2 weeks.
15815154|NCT04324554|Diagnostic Test|MRI of the right knee|An MRI of the right knee will be done to define the role of imaging in the diagnosis of early femoro-patellar osteoarthritis.
15815155|NCT04324541|Diagnostic Test|PET scan of the brain with Flortaucipir|PET scan of the brain with non FDA approved Radio tracer.
15815156|NCT04324528|Device|vv-ECMO + cytokine adsorption (Cytosorb adsorber)|in COVID-19-diseased vv-ECMO patients additional treatment with cytokine adsorption using a Cytosorb adsorber will be randomized (vs. control group)
15815157|NCT04324528|Device|vv-ECMO only (no cytokine adsorption)|COVID-19-diseased treated with vv-ECMO
15815158|NCT04324515|Procedure|Robotic gastric bypass with or without cholecystectomy|Study Arm: robotic gastric bypass without cholecystectomy Control Arm: robotic gastric bypass with cholecystectomy
15815159|NCT04324489|Drug|DAS181|Patient receives nebulized DAS181 (4.5 mg BID/day, a total 9 mg/day) for 10 days.
15815160|NCT04324476|Drug|Bevacizumab、Oxaliplatin、Irinotecan、Capecitabine|Drug: Bevacizumab 5mg/kg, iv, 30min, d1, 2w; Drug: Oxaliplatin 85mg/㎡, iv, 120min, d1, 4W; Drug: Irinotecan 150mg/㎡, iv, 90min, d15, 4w; Drug: Capecitabine 1000mg/㎡, bid, d2-8, 2w.
15815161|NCT04324463|Drug|Colchicine|oral medication
15815162|NCT04324463|Drug|Interferon-Beta|subcutaneous injection
15815163|NCT04324463|Drug|Aspirin|oral medication
15815164|NCT04324463|Drug|Rivaroxaban|oral medication
15815165|NCT04324450|Device|MRI|"The MRI protocol is composed of:
~T1-weighted anatomical sequences
~DTI sequences
~resting functional MRI
~3D MR spectroscopic imaging"
15815166|NCT04324450|Behavioral|Cognitive assessment|Battery of neuropsychological tests
15815167|NCT04324437|Other|eRAPID online symptom monitoring in lung cancer|The eRAPID in lung cancer intervention is an online symptom monitoring system which provides tailored advice depending on the severity of symptoms reported. The system is integrated into the electronic medical record and results can be viewed by the medical team.
15815168|NCT04324424|Drug|HMS5552|single dose of HMS5552 25mg
15815169|NCT04324411|Drug|sirolimus and ATRA|sirolimus (serum concentration 4-10ng/ml) and ATRA 20mg bid
15815170|NCT04324398|Other|Cryotherapy|cold application
15815171|NCT04324372|Drug|HEC68498|HEC68498 is a potent,highly selective inhibitor of class 1 isozymes of phosphoinositide 3-kinase/mammalian(PI3K) and of the mammalian target of rapamycin (mTOR). It has shown good activity against fibrosis and inflammation in vitro and in vivo, with a lower effective dose and better efficacy than pirfenidone and nintedanib.
15815173|NCT04324346|Drug|FEC75 (or EC90) x 6|Type of Chemotherapy
15815174|NCT04324346|Drug|FEC100 + Taxotere (EC90 + Taxotere) 3+3|Type of Chemotherapy
15815175|NCT04324346|Drug|Paclitaxel|Type of Chemotherapy
15815176|NCT04324333|Behavioral|Digital wearable system|Owlytics Healthcare's system is dedicated to improving the lives of all seniors by using the predictive power of data analytics.
15815177|NCT04324320|Diagnostic Test|medical assessment|"medical assessment includes the collection of
~sociodemographic data
~anthropometric data (weight, height, body mass index)
~medical data
~psycho-oncologic basis assessment (PO-BADO questionnaire)
~pain assessment (VAS: visual analogue scale)
~3 functional tests:
~handgrip strength
~6 Minute Walking Test
~Timed Get up and Go Test"
15815178|NCT04324320|Diagnostic Test|psychological assessment|"psychological assessment includes several standardized screening and assessment questionnaires and tools:
~quality of life: SF-36
~anxiety, depression, stress: Hospital Anxiety and Depression Scale (HADS-D)
~subjective stress perception: Perceived Stress Scale (PSS-10)
~resilience: resilience scale (RS-13)
~fatigue: Brief Fatigue Inventory (BFI)
~disability related to pain: Pain Disability Index (PDI)
~workability: Work Ability Index - short version (WAI-K)
~psychological assessment based on the checklist of the International Diagnoses (IDCL) for ICD-10 and the ICD-10 checklist of symptoms for psychological disorders (SCL))"
15815179|NCT04324307|Drug|PD-L1/CTLA4 BsAb|PD-L1/CTLA4 BsAb 5mg/kg, iv，Q2W
15815180|NCT04324307|Combination Product|GP|Gemcitabine 1000mg/m2, iv, D1,8,15, 28days/cycle; nab-Paclitaxel 125mg/m2，iv，D1,8,15, 28days/cycle;
15815181|NCT04324307|Combination Product|FOLFIRINOX|Fluorouracil 2400mg/m2，iv，D1, 14days/cycle; Oxaliplatin 68-85mg/m2，iv, D1,14days/cycle;Irinotecan135-180mg/m2，iv, D1, 14days/cycle;Calcium Folate 400mg/m2，iv, D1, 14days/cycle;
15815182|NCT04324294|Drug|EUS enhanced with contrast to evaluate pancreas|Patients will receive intravenous contrast during EUS to assess whether it improves the evaluation of pancreas.
15815183|NCT04324281|Other|Investigation|cadaveric dissection
15815184|NCT04324268|Drug|lirentelimab (AK002)|Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
15815185|NCT04324268|Other|Placebo|Placebo
15815186|NCT04324255|Procedure|LT|Liver transplantation
15815187|NCT04324242|Other|abdominal hallowing maneuver|abdominal hallowing maneuver includes tucking navel in and up. To be able to control the effect of breathing it was instructed to start the maneuver at the end of the expiration. During the maneuver it was instructed to focus on increasing the thickness of TrA without increasing the thickness of IO and EO
15815188|NCT04324229|Drug|Liraglutide 6 MG/ML [Victoza]|Starting dose of liraglutide 0.6 mg will be administered for one week, after which dose will be escalated to liraglutide 1.2 mg for one week and thereafter liraglutide 1.8 mg s.c. daily injections.
15815189|NCT04324229|Drug|Placebos|Starting dose of placebo 0.1 ml will be administered for one week, after which dose will be escalated to placebo 0.2 ml for one week and thereafter placebo 0.3 ml s.c. daily injections.
15815190|NCT04324216|Other|3D virtual reality and hands-on aromatherapy|Participants will receive 8-session 3DVR aroma therapy activities. Each session was delivered over 2 hours once a week, and at each session, the participant received hands-on guidance for preparing an aromatherapy product that they could use for the next seven days.
15815191|NCT04324203|Other|Three-dimensional Virtual Reality and Horticultural Therapy|VR is a realistic, three-dimensional, and virtual environment formed by a combination of computer software and hardware
15815192|NCT04324190|Behavioral|Guided online support program|"Guided online support program consisting of several modules; Module General information ... is an unspecific control module (providing general information on hygiene etc. with no expected effect on outcomes)"
15815193|NCT04324190|Behavioral|WHO recommendations (waiting condition)|"During the waiting period, a german translation of the WHO recommendations Coping with stress during the 2019-nCoV outbreak is provided"
15815194|NCT04324177|Other|Demographic data, morbidity data|To detect association between the demographic data of pediatric patients including age ,sex,hospital stay and clinical data including the diagnosis and co morbidity with the outcome of pediatric patients admitted to ICU of Assiut University children hospital
15815197|NCT04324112|Drug|binimetinib|Binimetinib will be given orally at a dose of 45mg BID continuously for 28-day cycles with no resting period between cycles.
15815198|NCT04324112|Drug|Encorafenib|Encorafenib will be given orally at a dose of 450mg QD continuously for 28-day cycles with no resting period between cycles.
15815199|NCT04324099|Other|neuroimaging session (with simultaneously acquired eye-tracking)|neuroimaging session, including two functional neuroimaging paradigms (ca. 15-20 minutes each) and a short structural image acquisition (mprage) for coregistration. Functional Magnetic Brain Imaging (fMRI) and simultaneous eye-tracking data will be collected during the paradigms: 1) an emotion processing paradigm (adapted from Passamonti et al., 2010); and 2) an emotional Go/noGo paradigm (adapted from Hare et al., 2008).
15815200|NCT04324099|Other|Questionnaire (for children) assessing traumatic experiences (Childhood trauma questionnaire (CTQ))|The Childhood Trauma Questionnaire is a brief survey of six early traumatic experiences (death, divorce, violence, sexual abuse, illness or other), and assesses individual's understanding of their childhood trauma.
15815201|NCT04324099|Other|Social and Health Assessment (SAHA) questionnaire (for children)|Self reported survey assessing social and mental health with four aspects of parenting determined (parental involvement, parental warmth, parental control, and inconsistency of parenting).
15815202|NCT04324099|Other|Massachusetts Youth Screening Instrument (MAYSI-2) (for children)|"The Massachusetts Youth Screening Instrument (MAYSI-2) is a screening instrument developed for detecting mental health needs in youth aged 12-17. Designed as a low-cost, easily administered tool, it screens for multiple issues and can be administered in 10-15 minutes. It is divided into seven scales composed of 52 questions that are designed to detect alcohol/drug use, angryirritable behavior, depression-anxiety, somatic complaints, suicide ideation, thought disturbance, and traumatic experience. Youths answer YES or NO concerning whether each item has been true for them within the past few months."
15815203|NCT04324099|Other|Interpersonal Reactivity Index (IRI) (for children)|The Interpersonal Reactivity Index is a measure of dispositional empathy that takes as its starting point the notion that empathy consists of a set of separate but related constructs. The instrument contains four seven-item subscales (seven Likert items each), each tapping a separate facet of empathy (Empathic Concern, Perspective Taking, Personal Distress, and Fantasy). The 28-item IRI contains four subscales
15815204|NCT04324099|Other|Youth Psychopathic Traits Inventory (YPI) (for children)|self-report screening measures to assess psychopathic traits in youth assessing 10 core personality traits associated with the construct (grandiosity, lying, manipulation, callousness, unemotionality, impulsivity, irresponsibility, dishonest charm, remorselessness, and thrill seeking). Each item is scored on an ordinal 4-point Likert scale (1 = Does not apply at all, to 4 = Applies very well). Higher scores reflect an increased presence of psychopathic traits.
15815205|NCT04324099|Other|Reactive Proactive Questionnaire (RPQ) (for children)|The Reactive-Proactive Questionnaire (RPQ) scores (0 (never), 1 sometimes, 2 (often)) for proactive aggression items and reactive items. Proactive and reactive scale scores are summated to obtain total aggression scores.
15815206|NCT04324099|Other|Emotion Regulation Questionnaire (for children)|10-item scale designed to measure respondents' tendency to regulate their emotions in two ways: (1) Cognitive Reappraisal and (2) Expressive Suppression. Respondents answer each item on a 7-point Likert-type scale ranging from 1 (strongly disagree) to 7 (strongly agree)
15815207|NCT04324099|Other|Basic Empathy Scale (BES) (for children)|The Basic Empathy Scale (BES) measures 20 items (affective and cognitive empathy) on a Five-point Likert-type scale.
15815208|NCT04324099|Other|Pubertal Development Scale (PDS) (for children)|self-report measure of physical development which has been shown to be correlated with measures of pubertal development derived from physical examination. Responses are coded on 4-point scales (1 = no development and 4 = completed development). For girls, a yes-no question about onset of menarche is weighted more heavily (1 = no and 4 = yes). For both genders, ratings are then averaged to create an overall score for physical maturation.
15815209|NCT04324099|Other|Alabama Parenting Questionnaire (APQ) (for parents)|The APQ measures five dimensions of parenting that are relevant to the etiology and treatment of child externalizing problems: (1) positive involvement with children, (2) supervision and monitoring, (3) use of positive discipline techniques, (4) consistency in the use of such discipline and (5) use of corporal punishment (42 self-reported responses, rated on a 5-point Likert scale- 1 (never) to 5 (always) for both child and parent forms)
15815210|NCT04324099|Other|Inventory of Callous Unemotional Traits (ICU) (for parents)|24-item questionnaire designed to provide a comprehensive assessment of callous and unemotional traits.The ICU has three subscales: Callousness, Uncaring, and Unemotional. The ICU is made up of statements with a 4-point Likert scale, ranging from 0 (Not at all true) to 3 (Definitely True), with higher scores indicating greater CU traits.
15815211|NCT04324099|Other|Child Behavior Checklist (CBCL) (for parents)|"The eight empirically-based syndrome scales are:
~Aggressive Behavior
~Anxious/Depressed
~Attention Problems
~Rule-Breaking Behavior
~Somatic Complaints
~Social Problems
~Thought Problems
~Withdrawn/Depressed. Higher scores indicate greater Problems."
15815212|NCT04324099|Other|Griffith Empathy Measure (GEM) (for parents)|self-report 23-item measure of empathy in which the respondent answers each item on a nine-point Likert scale from strongly disagree to strongly agree
15815213|NCT04324099|Other|Social Responsiveness Scale (SRS) (for parents)|Social Responsiveness Scale (SRS) measures social ability of children from 4 years to 18 years old. It is used primarily with individuals with Autism Spectrum Disorder (ASD), family members of individuals with ASD, and others who have social impairments. Parent or teacher questionnaire (65 items on a 4-point Likert scale). High scores are associated with more severe social impairments.
15815214|NCT04324086|Device|Calcium hydroxide with XP-endo Finisher file|XP-endo Finisher files (FKG Dentaire, La Chaux-de-Fonds, Switzerland). file will be used with an endodontic motor X-Smart (Dentsply Sirona, Ballaigues, Switzerland) in removal of calcium hydroxide
15815215|NCT04324086|Device|Calcium hydroxide with Irrisafe Ultrasonic tip|passive ultrasonic irrigation (PUI) with an IrriSafe Ultrasonic tips (Acteon,France), which will be driven by an ultrasonic device (Newtron P5, Satelec, Acteongroup, Merignac, France) in reemoval of calcium hydroxide
15815216|NCT04324086|Device|Calcium hydroxide with side vented needle|conventional syringe irrigation with side vented needle (prime Dent, India) in removal of calcium hydroxide
15815217|NCT04324073|Drug|Sarilumab|(an IV dose of 400 mg of sarilumab in a 1 hour-infusion at D1
15815866|NCT04318665|Diagnostic Test|CT Perfusion|Severe Traumatic Brain Injury patients will be undergoing CT perfusion test
15815218|NCT04324060|Drug|Danazol + rhTPO (recombinant human thrombopoietin injection)|subcutaneous injection, 300U/kg/d×14d every month，stop if the PLT≥100×10e9/L or increased >50×10e9/L, total course is 6 months
15815219|NCT04324060|Drug|Danazol + sodium chloride|Danazol 0.2g tid po+ control (sodium chloride)
15815220|NCT04324034|Device|vNOTES|vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is vaginal surgery with a natural approach. The GelPOINT V-path transvaginal access platform is used. It is a device designed to be placed transvaginally to establish a pathway for the insertion of minimally invasive instruments while maintaining insufflation to perform diagnostic or operative procedures. This device also allows a passage for the extraction of operating parts.
15815221|NCT04324034|Procedure|laparoscopy|The surgery by conventional laparoscopy is used
15815222|NCT04324021|Biological|Emapalumab|I.v infusion every third day
15815223|NCT04324021|Biological|Anakinra|Daily i.v infusion
15815224|NCT04324008|Device|Constic|Flowable resin composite
15815225|NCT04324008|Device|G-ænial Universal Flo|Flowable resin composite
15815226|NCT04324008|Device|Tetric N-Flow (self-etch)|Tetric N-Flow (Tetric N-Bond Universal, self-etch mode)
15815227|NCT04324008|Device|Tetric N-Flow (etch&rinse)|Tetric N-Flow (Tetric N-Bond Universal, etch&rinse mode)
15815228|NCT04323995|Other|Sprint Interval Training|Sprint interval training of 2 weeks and more.
15815229|NCT04323982|Procedure|new surgical procedure|（ACCC + I / A + PCCC + TA+ A-vit) or （ACCC + I / A + PCCC + IOL + TA + A-vit）
15815230|NCT04323982|Procedure|traditional surgical procedure|（ACCC + I / A + PCCC + A-vit) or （ACCC + I / A + PCCC + IOL + A-vit）
15815231|NCT04323969|Behavioral|Specific Modification Target|Participants will be instructed to increase their baseline foot progression angle by 15 degrees. Visual feedback during practice will be delivered using a mirror and guideline (tape placed on mirror). Verbal feedback will be incorporated to encourage participants to perform the modified foot progression angle as accurately as possible.
15815232|NCT04323969|Behavioral|Self-directed Modification|Participants will be instructed to modify their foot progression angle as much as is comfortable. A mirror will be used during practice for visual feedback, but no specific target or guide will be provided.
15815233|NCT04323956|Drug|Cyclophosphamide|Given IV
15815234|NCT04323956|Drug|Doxorubicin Hydrochloride|Given IV
15815235|NCT04323956|Drug|Parsaclisib|Given PO
15815236|NCT04323956|Biological|Pegfilgrastim|Given SC
15815237|NCT04323956|Drug|Prednisone|Given PO
15815238|NCT04323956|Biological|Rituximab|Given IV
15815239|NCT04323956|Drug|Vincristine Sulfate|Given IV
15815240|NCT04323943|Device|Ankle Foot orthosis (AFO)|"The experimental protocol will require 4 visits: one inclusion visit and 3 visits for evaluations. Each visit corresponds to one condition: C-AFO, CM-AFO or NO (according to a random order).
~Visit #1 will consist in a clinical evaluation and a familiarization session with the measuring devices and methodologies used in visit#2 #3 and #4.
~During #2, #3 and #4 visits (14 days between each session), the subject will perform with C-AFO, CM-AFO or NO according to the random order :
~5 x 15m overground at a comfortable walking speed (CWS) where EMG, ground reaction force and kinematics will be measured
~6MWT where energy cost will be measured
~5 x 15m overground (immediately after the 6MWT) at a comfortable walking speed"
15815241|NCT04323930|Device|eyeWatch|The eyeWatch system will be implanted as per the manufacturer's instruction, and trabeculectomy will be performed using mitomycin C as per standard surgical protocols.
15815242|NCT04323917|Diagnostic Test|Liquid biopsy|Detection and quantification of EMT-transcription factor mRNA levels in blood
15815243|NCT04323904|Other|Retrospective data collection|Retrospective data collection from patients with hantavirus infection and matching control group patients.
15815244|NCT04323865|Diagnostic Test|fetal heart rate variability|No direct intervention, as the study is observational.
15815247|NCT04323839|Other|Pregnant women under investigation for Coronavirus or diagnosed with COVID-19|This is an observational study with no intervention
15815248|NCT04323839|Other|Postpartum women under investigation for Coronavirus or diagnosed with COVID-19|This is an observational study with no intervention
15815249|NCT04323826|Other|olive oil-water mixture|50% olive oil in water, processed with high shear mixer at 8000 rpm power without adding emulsifier, well shaked before consumption.
15815250|NCT04323826|Other|olive oil-water emulsion|50% olive oil in water (4% whey protein isolate), stirred for 5 mins using a high shear mixer at 8000 rpm power and was further processed with high pressure homogenizer at 100 MPa.
15815251|NCT04323826|Other|coconut oil-water mixture|50% coconut oil in water, processed with high shear mixer at 8000 rpm power without adding emulsifier, well shaked before consumption.
15815252|NCT04323826|Other|coconut oil-water emulsion|50% coconut oil in water (4% whey protein isolate), stirred for 5 mins using a high shear mixer at 8000 rpm power and was further processed with high pressure homogenizer at 100 MPa.
15815253|NCT04323813|Diagnostic Test|Liquid biopsy|Detection and quantification of EMT-transcription factor mRNA levels in blood
15815254|NCT04323800|Biological|Anti- SARS-CoV-2 Plasma|SARS-CoV-2 convalescent plasma (1 unit; ~200-250 mL collected by pheresis from a volunteer who recovered from COVID-19 disease and has SARS-CoV-2 antibody titers ≥ 1:320
15815255|NCT04323800|Biological|SARS-CoV-2 non-immune Plasma|Normal human plasma collected prior to December 2019
15815256|NCT04323787|Other|observational|No Intervention
15815257|NCT04323774|Behavioral|AYA-RISE Adolescents and Young Adults Risk Information and Screening Education|A chatbot is a computer program that can chat with humans. The text the chatbot uses to talk with humans was created by real people, but the chatbot itself is not a real person. A company called Clear Genetics developed the original chatbot and patient portal, and this study team customized it for this research study.
15815258|NCT04323774|Behavioral|Standard clinical visit for genetic counseling|Standard clinical visit for genetic counseling and follow up
15815259|NCT04323761|Drug|Remdesivir|Intravenous infusion administered over a 30 to 120 minute period
15815867|NCT04318652|Drug|Methylprednisolone eyedrops|instillation of methylprednisolone eye drops
15815260|NCT04323748|Drug|rituxan|"The dose dense administration of rituximab will consist of 5 doses total
~Days: 0, 2, 7 (± 2 days), 14 (± 2 days), and 21 (± 2 days); Dose: 375 mg/m2"
15815261|NCT04323735|Drug|Culturelle 10 Billion CFU Capsule|"LGG® (Culturelle Probiotic with Lactobacillus RhamnosusGG, shown to produce the largest amount of antibacterial substances against pathogenic bacteria) will be used. For the LGG® instillation, participants will be instructed to mix the contents of 1 LGG capsule into 45 cc sterile 0.9% saline. After mixing, participants will draw up the 45cc liquid LGG mixture into a 60cc syringe and instill via the indwelling catheter (the catheter will not be changed as this would represent 2 interventions). Participants will be instructed the plug their catheter for 1 hour. Participants will receive 2 or 4 LGG capsules (depending on randomization group) and will repeat this process the following day (Low dose) or twice daily for a total of four doses (High dose) according to randomization group."
15815262|NCT04323722|Procedure|Empty Bladder planning CT scan and CBCTs|Patient will receive a Planning CT scan, 3 CBCTs on the first week and once a week during radiotherapy treatment with an Empty Bladder
15815263|NCT04323709|Other|Data collection|Clinical data are collected from the medical record of the institution. At admission, date were collected on age, gender, body mass index, Simplified Acute Physiology Score II, Sequential Organ Failure Assessment, hypertension, diabetes, hypercholesterolemia, smoking, history of stroke or congestive heart failure, coronary or peripheral artery disease, renal failure with dialysis, Left Ventricular Ejection Fraction(LVEF), Tricuspid Annular Plane Systolic Excursion, mean arterial pressure, heart rate, central venous pressure, ScvO2, presence of an intra-aortic balloon pump and biochemical parameters. During hospitalization data were collected on reason for initiation of VA-ECMO and its characteristics (duration, type, flow L/min, RPM, FiO2), length of stay in ICU, catecholamines and inotropes maximal dose and length of administration, patients with heart transplantation or LVAD. In patients with levosimendan treatment, timing of administration regarding ECMO canulation was collected
15815264|NCT04323709|Other|Data analysis|Continuous variables were presented as mean ± standard deviation and compared using Student's t-test or Mann-Whitney U-test depending on their normality. Categorical variables were presented as counts and percentages and compared using Pearson's chi-squared test or Fisher's exact test, as appropriate. Survival at day 28 was estimated using the Kaplan-Meier method and compared using the log rank test. Investigators conducted a multivariable logistic regression with propensity score matching, which was defined as the probability of exposure to levosimendan. Results were reported as odd ratios (ORs) together its 95%CI assuming a 5% level of statistical significance. All analyses were carried out using STATA 15.0 (Stata Corp, College Station, Texas 77845 USA).
15815265|NCT04323696|Procedure|Staple line suturing reinforcement methods - Plication and Over-sewing|Sleeve gastrectomy procedure will be performed laparoscopically. The greater curvature of the stomach will be mobilised, and stomach will be sleeved using 39F calibration tube as the stent using 5-6 60 mm-stapler reloads depending on the length and thickness of the stomach. The staple-line is then reinforced using 3/0 absorbable sutures continuously throughout the staple-line. The two staple-line suturing methods in this study include over-sewing (through and through) and plication (Lembert).
15815266|NCT04323683|Genetic|Microarray|High throughput technique for determining global gene expression of the condition of interest
15815267|NCT04323670|Device|"Selectra 3D guiding catheter"|His lead measurements
15815268|NCT04323657|Drug|TC-110 T Cells|TC-110 T Cells
15815269|NCT04323657|Drug|Fludarabine|Flu/Cy Lymphodepletion
15815270|NCT04323657|Drug|Cyclophosphamide|Flu/Cy Lymphodepletion
15815271|NCT04323644|Procedure|Surgery|Emergency or elective surgery
15815272|NCT04323631|Drug|Hydroxychloroquine|Oral
15815273|NCT04323631|Other|The control group will not receive hydroxychloroquine|The control group will not receive hydroxychloroquine
15815274|NCT04323618|Device|Breathe Well|
15815275|NCT04323605|Other|"Outpatient assistance program for transplant patients (AMA-ALLO) based on a navigation nurse"|"Integration of a post-transplant navigation nurse starting at the first post-transplant consultation (starting from D100 +/- 10 days post-transplant). Different times for post-transplant telephone monitoring (every week for the first 2 months, then every 15 days for the next 3 months then once a month for 7 months)"
15815276|NCT04323592|Drug|Methylprednisolone|Usual standard of care plus Methylprednisolone (MP) 80 mg/kg IV bolus, followed by MP infusion of 80 mg/day in 240 mL normal saline at 10 mL/h. The infusion is continued for at least eight days and until achieving either a PaO2:FiO2 > 350 mmHg or a CRP < 20 mg/L. Treatment is then switched to oral administration of Methylprednisolone 16 mg or 20 mg IV twice daily until CRP returns to < 20% of normal range and/or PaO2:FiO2 > 400 or SatHbO2 ≥ 95%. The decision to apply the protocol to Covid-19 is left to the discretion of the treating team for each individual patient.
15815277|NCT04323592|Other|standard care|"usual standard of care:
~oxygen therapy (regular or high-flow) and monitoring
~empiric antibiotic therapy
~mechanical ventilation (invasive or noninvasive)
~ECMO when needed and available
~pronation when possible
~other treatment which can be used are: antivirals, chloroquine, vitamins"
15815278|NCT04323566|Drug|Rituximab|"Rituximab 500 mg, dissolved in 250 ml NaCl in an infusion bag, covered with non-see-through plastic
~administered iv over a course of max 180 minutes
~at 0 and 4 months (treatment-first arme) OR at 8 and 12 months (placebo-first arm)"
15815279|NCT04323553|Diagnostic Test|Pulsed-field gel electrophoresis and whole genome sequencing|Comparison of the two different techniques
15815280|NCT04323553|Other|Data collection|Demographic data (age, gender, hospital admission and discharge date, rooms and wards with dates of admission and discharge, hospitalization prior to current hospital stay, discharge destination, outcome, cause of death, travel history, recent hospitalization in an ESBL-high burden region, admission from another healthcare facility, admission from a long-term care facility, occupational or household contact to animals) Clinical data (date of diagnosis of ESBL-producing E. coli carriage, type of infection/colonization with ESBL- producing E. coli, comorbidities, Charlson Comorbidity Index, infectious diseases after detection of ESBL-PE, active open wounds, indwelling vascular devices, urinary catheterization) Treatment data (Immunosuppression, antibiotic therapy, concomitant medication and surgical therapy prior to and during hospital stay) Microbiological data
15815305|NCT04323332|Drug|Traditional Chinese Medicine Prescription|Traditional Chinese Medicine Prescriptions have been recommended according to the Guidelines for the treatment of COVID-19 issued by National Health Commission of the PRC.
15816064|NCT04316936|Drug|Dexycu, 9% Intraocular Suspension|dexamethasone intraocular suspension
15815281|NCT04323540|Procedure|Peri-implantitis reconstructive surgery|"For both arms (excluding the already included information): defect debridement, removal of debris using titanium curettes, titanium brushes on the implant surface, irrigation with saline, application of sterile cotton pellets with saline solution. Grafting with (experimental) xenograft and soft tissue, or xenograft alone (control). Suture.
~Specific to control group (active comparator): the peri-implant defect will be filled with xenograft, and a collagen membrane will be fitted and trimmed to the defect area.
~Specific to test/experimental group: same as above (for control). In addition a soft tissue graft will be harvested from the palate and sutured to the buccal flap. The entire flap will then be sutured to the lingual flap."
15815282|NCT04323527|Drug|Chloroquine diphosphate|150mg chloroquine diphosphate tablets. Note: Tablets used in the study were Chloroquine Diphosphate (produced by Farmanguinhos/Fiocruz), and the dosing stated in the clinicaltrials.gov refers to chloroquine base (in mg).
15815283|NCT04323514|Dietary Supplement|Vitamin C|10 gr of vitamin C intravenously in addition to conventional therapy.
15815284|NCT04323501|Other|Experimental treatment|"Exercises may include UPPER LIMB Passive exercises (stretching), each one greater or equal to 10 minutes; greater or equal once a day: pectoralis; back muscles and triceps; subscapular muscle; elbow flexor; both pronator muscles; flexor of the wrist and fingers; flexor, adductor and opponent muscles of the thumb.
~Active exercises: multiple repetitions possible in 1 minute each one greater or equal to three times a day: shoulder abduction, flexion, external rotation; elbow extension and supination; wrist extension; finger extension; thumb extension and abduction.
~LOWER LIMB Passive exercises, each one greater or equal to 10 minutes; greater or equal once a day: hamstring; adductor of the hip; gluteus muscles.
~Greater or equal to 5 minutes; greater or equal to twice a day: soleus and gastrocnemius.
~Active exercises: multiple repetitions possible in 1 minute each one greater or equal to three times a day: hip abduction and flexion; knee flexion; dorsiflexion of ankle; seat-standing"
15815285|NCT04323501|Other|Control group|Usual care
15815286|NCT04323488|Behavioral|Lindamood-Bell Seeing Stars|Seeing Stars in a curriculum developed by Lindamood-Bell. It is published and openly available. It involves systematic training in the building blocks of skilled reading.
15815287|NCT04323475|Biological|Bacteriophage cocktail spray|Study intervention consists of a dosage-metered airless spray containing a cocktail of 14 bacteriophages at a concentration of 1.4 x 10^8 PFU/mL for an effective dosage of 2.5 x10^5 PFU/cm^2 of burned area. The study intervention will be applied in conjunction with standard of care.
15815288|NCT04323475|Drug|Xeroform|Standard of care will consist of Xeroform primary dressing and Kenacomb topical antibiotic cream (for wounds with signs of localized infection)
15815289|NCT04323462|Drug|Insulin Glargine|Three times bolus insulin with regular or Shorter acting insulin
15815290|NCT04323462|Drug|Diabetic DM|Previously receiving OADs and/or basal insulin
15815291|NCT04323449|Device|Compare two control methods for a wheelchair-mounted robotic manipulator|Participants will pay one visit to the lab where they will be asked to complete a set of manipulation tasks using a wheelchair-mounted robotic manipulator using the new custom vision-guided control and default joystick or switch control. The sequence of the two control methods will be counterbalanced.
15815292|NCT04323436|Drug|Spartalizumab|Concentrate for solution for infusion
15815293|NCT04323436|Drug|Capmatinib|Film-coated tablet
15815294|NCT04323436|Drug|spartalizumab placebo|dextrose 5% in water (D5W) for infusion
15815295|NCT04323423|Behavioral|interrupting sedentary behaviour with light physical activity|replacing sitting with light walking bouts at different frequencies/durations
15815296|NCT04323410|Procedure|Cast immobilization|Cast immobilisation is done using finger trap traction. The fractured forearm is splinted above elbow with dorsal cast without attempted reduction.
15815297|NCT04323410|Procedure|Percutaneus pinning|Reduction under fluoroscopic guidance and fixation using two crossing 1.6mm K-wires.
15815298|NCT04323397|Device|Non-invasive ventilation|Intervention nasal high frequency oscillatory ventilation (nHFOV) and nasal synchronized intermittent positive pressure ventilation (nSIPPV) were generated by neonatal ventilators (SLE6000 infant ventilators, United Kingdom) using bi-nasal prongs (RAM cannula, NEOTECH®, USA) or the nasal mask of the same type for both ventilation modes. The size of the prongs was determined by the infant's weight. The largest possible prongs were used, with a snug fit to avoid leakage. Pacifier for preterm and term neonate (Jollypop™, USA) was taken to avoid leakage from the mouth. The disposable ventilator circuit (Fisher & Paykel RT268™, Evaqua Dual Limb Infant Breathing Circuit Kit with Evaqua 2 Technology and Pressure Line, Flow > 4L/min, New Zealand) was used. The initial NIV setting was (7) described in arm description. (above)
15815299|NCT04323384|Device|Biotene® Oralbalance Moisturizing Gel|Biotene® Oralbalance Moisturizing Gel will be applied to the oral cavity according to the package directions.
15815300|NCT04323371|Diagnostic Test|ELISA|Blood and derived fluids will be collected from 26 ADHF CS patients admitted to intensive care at Niguarda Hospital and locally stored.Stocked samples will be shipped to the Central Laboratories at Milano Uni and MilaIFC-CNR for the metabolomic and biomarkers analysis,respectively.To evaluate interleukin-6 (marker of systemic inflammation),angiopoietin-2 (marker of endothelial permeability), syndecan-1 and heparan sulfate (markers of endothelial glycocalyx),2 aliquotes of serum samples will be used by IFC CNR.The biomarkers will be assessed through ELISA analytical techniques, based on the interactions inside a microplate between a primary pre-coated antibody and the specific protein contained in serum samples.A secondary antibody, link to a horseradish peroxidase (HRP) detection system, is able to recognize and bind the antigen, and to produce a colorimetric reaction after the addition of enzyme substrate which is proportional to the amount of the target protein bound
15815301|NCT04323358|Diagnostic Test|Biometry|Patients will be asked to place the chin in position and open their eyes wide. In between measurements, the patient will be arranged so his eyes are in one horizontal line and each time before measurement the patient will be asked to blink several times.
15815302|NCT04323358|Diagnostic Test|Keratometry|Patients will be asked to place the chin in position and open their eyes wide. In between measurements, the patient will be arranged so his eyes are in one horizontal line and each time before measurement the patient will be asked to blink several times.
15815303|NCT04323345|Dietary Supplement|Natural Honey|Natural Honey supplement 1gm/kg/day divided into 2 to 3 doses for 14 days either orally or through nasogastric tube.
15815304|NCT04323345|Other|Standard Care|Supportive measures and lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate or Hydroxychloroquine or oseltamivir with or without azithromycin.
15815306|NCT04323319|Device|ESWT, Graston Technique|"The treatment period for each group was determined as 4 weeks. Stretching program for each group will be given as home exercise program. Stretching exercises will be completed in 3 sets, 2 sets per day, stretching for 30 seconds.
~Graston Technique Group will take treatment 2 times per week, ESWT group will take treatment 1 time per week."
15815307|NCT04323306|Drug|MMV688533|Investigational medicinal product
15815308|NCT04323293|Other|Cold Water Bath|immersion of the hand for 2-5min in 2-10°C water
15815309|NCT04323293|Other|Neutral Water Bath|immersion of the hand for 2-5min in 32±2°C water
15815310|NCT04323280|Drug|Dexamethasone therapy|Dexamethasone 20MG once daily for 4 days with additional colchicine therapy for 3 months
15815311|NCT04323280|Drug|NSAID therapy|NSAIDS (Ibuprofen or Aspirin) or Glucocorticoid (Prednisone) therapy for 3 weeks with addional colchicine therapy for 3 months
15815312|NCT04323267|Device|Limber Digital Application|A mobile application was recently developed to address these needs. The application provides evidence-based, symptom specific home-exercise video programs for MSK conditions, as well as clinically-validated outcome measures for tracking progress.
15815313|NCT04323267|Behavioral|Physical therapy Therapy|Therapy prescription 2 x a week for 8 weeks (specified by physician)
15815314|NCT04323241|Other|Controlled cord traction|In group 2, Spontaneous removal will be performed by massaging on the uterine fundus and applying gentle traction on the umbilical cord.
15815315|NCT04323228|Dietary Supplement|Oral supplement enriched in antioxidants|the intervention group will receive a commercially available antioxidant supplement, which will be given to patients with COVID-19 in the morning after breakfast.
15815316|NCT04323228|Dietary Supplement|cellulose-containing placebo capsules|The placebo group will receive an oral supplement at the same time in the same shape/size/color.
15815317|NCT04323215|Device|Support system|A support system named Provement will be used to provide behavioral treatment.
15815318|NCT04323202|Drug|Pembrolizumab|Post Fine-cut CT: 4 doses of pembrolizumab (200mg) IV q 3 weeks. Post standard resection and reconstruction: 1 year of pembrolizumab (200mg) q 3 weeks (another 13 doses, thus 17 doses total)
15815319|NCT04323202|Other|Tissue collection|Non-marginal tissue as well as pre-op biopsy tissue to be stored
15815320|NCT04323189|Drug|Sitagliptin 100mg|Sitagliptin will be administered daily for 7 days, with a study day on day 7.
15815321|NCT04323189|Drug|Placebo Oral Tablet|Placebo will be administered daily for 7 days, with a study day on day 7.
15815322|NCT04323176|Other|Village Model implementation|Participate in the Village Model using a website
15815323|NCT04323163|Behavioral|Physical Activity|3 sessions per week, 60 minutes per session for 6 months
15815324|NCT04323150|Device|Closed suction systems|Closed suction systems are using for prevention of the ventilator-associated pneumoniae
15815325|NCT04323150|Device|Conventional suction system|The using of open (conventional) suctioning
15815326|NCT04323137|Behavioral|Risk reduction|Mailed letter, SMS, and/or patient portal message
15815327|NCT04323137|Behavioral|Medical records-based recommendation|Mailed letter, SMS, and/or patient portal message
15815328|NCT04323137|Behavioral|Algorithm-based recommendation|Mailed letter, SMS, and/or patient portal message
15815329|NCT04323124|Drug|PF-07059013|Participants will recieve PF-07059013
15815330|NCT04323124|Drug|Placebo|Participants will recieve placebo
15815331|NCT04323111|Procedure|metzenbaum's technique|surgical procedure for correction of caudal end nasal septal deviation
15815332|NCT04323098|Biological|valoctocogene roxaparvovec|Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Hemophilia A
15815333|NCT04323085|Behavioral|Speech-in-Noise Treatment Program|Speech therapy program for hypophonia.
15815334|NCT04323085|Behavioral|Speech-to-Noise Feedback Device Program|Speech Feedback device program for hypophonia.
15815335|NCT04323072|Procedure|Wide antrectomy|The starting point of resection of the stomach from the pylorus to begin the gastrectomy is 2 cm.
15815336|NCT04323072|Procedure|Smal antrectomy|The starting point of resection of the stomach from the pylorus to begin the gastrectomy is 6 cm.
15815337|NCT04323059|Dietary Supplement|Standardized milk-based formulation|Nutritional formulations prepared from locally available food stuffs for reversing childhood malnutrition
15815343|NCT04323033|Device|PERS stent|"PERS® is a cobalt-chromium stent, made of cobalt-chromium alloy with drug (Sirolimus) and biodegradable polymer controlling drug elution.
~The length of the stent is selected to cover the treated lesion with a margin of 5 mm proximal and distal, while the diameter of the stent will be selected based on the QVA measurement (balloon to vessel ratio 1:1)."
15815344|NCT04323033|Device|NEPTUN C stent|Neptun C is balloon-expanding cobalt-chromium stent.
15815345|NCT04323020|Diagnostic Test|CT Perfusion|CT Perfusion
15815346|NCT04323007|Diagnostic Test|Nephrotic patients|Laboratory measures will include Blood sugar Urine analysis with 24hrs protein in urine Complete blood count Liver function tests Kidney functions test Plasma lipid levels Thyroid functions test Abdominal ultrasound Antithyrperoxidase Renal biopsy
15815347|NCT04322994|Device|Transnasal Humidified Rapid-Insufflation Ventilatory Echange|The use of high-flow nasal cannula to augment the ability to oxygenate and ventilate a patient under general anesthesia.
15815348|NCT04322981|Behavioral|Pharmacist-Led care|Rapid testing in a community pharmacy, with rapid linkage to care and treatment that is pharmacist-led
15815349|NCT04322981|Behavioral|Standard of Care (Hepatology)|Rapid testing in a community pharmacy, with standard of care referral to academic hepatology
15815350|NCT04322968|Drug|A single low dose ketamine infusion as compared to the IV infusion of active placebo - ketorolac on chronic pain and PTSD symptoms.|Subjects were randomized into 4 treatment groups: chronic pain subjects treated with ketorolac, chronic pain subjects treated with ketamine, chronic pain+PTSD subjects treated with ketorolac, and chronic pain+PTSD subjects treated with ketamine.
15815351|NCT04322955|Drug|Cabozantinib|2 x 20 mg capsules taken orally daily
15815352|NCT04322955|Drug|Nivolumab|480mg IV on first day of each 28-day cycle
15815353|NCT04322955|Procedure|Cytoreductive nephrectomy|Surgery removing as much tumor tissue as possible, possibly including surrounding tissues.
15815354|NCT04322942|Diagnostic Test|Monocyte Distribution Width|Monocyte Distribution Width as part of the CBC result.
15815355|NCT04322929|Drug|Roflumilast Oral Tablet|Roflumilast, a phosphodiesterase 4 (PDE4) inhibitor is approved worldwide (including Hong Kong) for treatment of severe chronic obstructive pulmonary disease (COPD) with frequent exacerbations. Roflumilast has been shown to have anti-inflammatory effect in patients with COPD, with significant reduction of sputum absolute neutrophil count, IL-8 and neutrophil elastase compared with placebo treatment. Roflumilast can also improve the lung function parameters in patients with COPD and reduce the rate of moderate-to-severe exacerbations.
15815356|NCT04322916|Device|RM Pressfit vitamys|Implantation of a RM Pressfit vitamys hip cup
15815357|NCT04322903|Behavioral|Passport to Freedom (P2F)|During the P2F sessions, the women learn to understand and process the impact of multiple traumas on women's lives and health and learn specific strategies to overcome the symptoms of trauma and everyday stress. Each session will begin and end with a mindfulness exercise to provide different strategies the women can use when these women are in a stressful situation. At the end of each session, the participants will complete a session evaluation. The women will also have a home visit or telephone call with a community health navigator who will conduct a social determinant of health screenings assessment to determine what identified social barriers these women may have. The community health navigator will help with linking the participant to a community agency that addresses the identified problem. Four weeks after the completion of the program, the women will be contacted for a follow-up interview to learn the effectiveness of the program sessions.
15815358|NCT04322877|Procedure|Temporary pacing Study|Temporary delivery of CRT
15815359|NCT04322877|Radiation|Thoracic CT|As part of non-invasive mapping protocol
15815360|NCT04322877|Diagnostic Test|Acute hemodynamic study|Measurement of invasive dP/dTmax
15815361|NCT04322877|Diagnostic Test|Non-invasive body surface mapping|Cardioinsight body surface mapping
15815362|NCT04322877|Diagnostic Test|Invasive catheter-based mapping|Invasive electroanatomical mapping
15815363|NCT04322864|Other|Therapeutic exercises|Patients will perform strengthening exercises focusing on scapulothoracic muscles and shoulder lateral rotators.
15815364|NCT04322851|Diagnostic Test|Lung ultrasound|Lung ultrasound performed at the time of extubation to evaluate B-line in patients with mechanical ventilation due to acute decompensated heart failure
15815365|NCT04322838|Diagnostic Test|MeDALL questionnaire for allergic diseases|Questionnaire about allergic symptoms and disease
15815366|NCT04322838|Diagnostic Test|Registration of allergic symptoms|Daily registration of allergic symptoms from eyes, nose and lungs on scale from 0-10 and daily registration of use of anti allergic medication from 1st of August to 15th of October.
15815367|NCT04322838|Diagnostic Test|Skin Prick Test|Diagnostic skin test for sensitization to allergens
15815368|NCT04322838|Diagnostic Test|Specific IgE in serum|Diagnostic test for sensitization to allergens in serum
15815369|NCT04322838|Diagnostic Test|Nasal provocation test|Diagnostic test for allergic rhinitis. Patients and controls are exposed to an allergen with a nasal spray. Allergic reactions are measured with Linder score and Pean Nasal Inspiratory Flow (PNIF)
15815370|NCT04322838|Diagnostic Test|Basophil Activation Test|Basophil leukocytes are extracted from full blood and exposed to 6 different doses of allergen and activation of basophils are measured.
15815371|NCT04322825|Device|TENS incorporated into the Mollii suit|trans cutaneous electric stimulation,
15815372|NCT04322812|Device|Active PBMT|The Active PBMT will be applied using MR5™ ACTIV PRO LaserShower Laser Therapy System, manufactured by Multi Radiance Medical (Solon, OH, USA) will be used. The ACTIV PRO emits 30mW of 905nm, 300mW of 850nm, 200mW of 660nm and 0mW of 455nm light via an electric diode energy source. PBMT will be applied using the direct contact method with light pressure on the skin. The PBMT application time will be 120 seconds per region and the total time will vary according to the number of regions to be treated. Only the painful regions on that day will be treated (according widespread pain index [WPI] ), which can comprise a minimum of 3 and a maximum of 18 regions in total. The dose used for applications during the treatment will be 60 Joules (J) per region. The total dose might vary between patients and each session.
15815373|NCT04322812|Device|Placebo PBMT|The placebo PBMT will be applied using MR5™ ACTIV PRO LaserShower Laser Therapy System, manufactured by Multi Radiance Medical (Solon, OH, USA). The ACTIV PRO emits 905nm, and 850nm via an electric diode energy source with outputs to 0%. The 660nm light via an electric diode energy source with outputs to >1% to appear like the active comparator. PBMT will be applied using the direct contact method with light pressure on the skin. The placebo PBMT application time will be 115 seconds per region and the total time will vary according to the number of regions to be treated. Only the painful regions on that day will be treated (according WPI), which can comprise a minimum of 3 and a maximum of 18 regions in total. The dose used for applications during the treatment will be 0 Joules (J) per region. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (active or placebo).
15815374|NCT04322799|Procedure|Device: Randomization between prosthetic components|Patients are randomized between two types of cup components in total hip arthroplasty. Identical cups made of either highly-crosslinked polyethylene or conventional polyethylene.
15815375|NCT04322786|Drug|ACE inhibitor|Any prescription of ACE inhibitor
15815376|NCT04322773|Drug|RoActemra iv|single dose treatment with tocilizumab 400 mg intravenously
15815377|NCT04322773|Drug|RoActemra sc|single dose treatment with tocilizumab 2 x 162 mg subcutaneously
15815378|NCT04322773|Drug|Kevzara sc|single dose treatment with sarilumab 1 x 200 mg subcutaneously
15815379|NCT04322773|Other|Standard medical care|management as usual
15815380|NCT04322760|Drug|Lidocaine 5% patch with Dexmedetomidine Bupivacaine|10 ml 0.5 % Bupivacaine and 1µg/kg Dexmedetomidine diluted in 10 ml saline was injected intra-articularly through one of the arthroscopic ports after the end of the surgery under complete aseptic technique and a patch of lidocaine 5% was applied to the skin between the arthroscopic ports
15815381|NCT04322760|Drug|Dexmedetomidine Bupivacaine|10 ml 0.5 % Bupivacaine and 1µg/kg Dexmedetomidine diluted in 10 ml saline was injected intra-articularly through one of the arthroscopic ports after the end of the surgery under complete aseptic technique without a patch of lidocaine 5%
15816065|NCT04316936|Drug|Prednisolone Acetate 1%|standard postoperative ophthalmic drop regimen
15815382|NCT04322747|Diagnostic Test|Distortion product otoacoustic emissions (DPOAE)|Audiometry for extended high frequencies, DPOAE, and, ECochG measurements will be collected before and after skull-based surgeries.
15815383|NCT04322708|Other|Placebo|Placebo
15815384|NCT04322708|Drug|lirentelimab (AK002)|Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
15815385|NCT04322695|Behavioral|Rehabilitation Education Care Program|The RECP contained the following domains: (1) assessment and detection of disability; (2) home exercise; (3) activities to improve mobility; (4) dietary management; (5) patient education; and (6) vocational counseling.
15815386|NCT04322682|Drug|Colchicine|Patients in this arm will receive study medication colchicine 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
15815387|NCT04322682|Drug|Placebo oral tablet|Patients will receive the placebo 0.5 mg per os (PO) twice daily for the first 3 days and then once daily for the last 27 days. If a dose is missed, it should not be replaced.
15815388|NCT04322669|Drug|Pidotimod|Participants will be randomized in ratio of 1:1 to receive Pidotimod 400 milligrams (mg), once daily (no infection present) or twice daily (infection present) orally up to Day 60 during the double-blind treatment period.
15815389|NCT04322669|Drug|Placebo|Participants will be randomized in ratio of 1:1 to receive placebo matched to Pidotimod, once daily (no infection present) or twice daily (infection present) orally up to Day 60 during the double-blind treatment period.
15815390|NCT04322656|Device|Lipiflow treatment|Patients will be treated on one eye with Lipiflow
15815391|NCT04322643|Drug|Pembrolizumab|Pembrolizumab 200 mg IV over 30 minutes every 3 weeks
15815392|NCT04322643|Drug|Atezolizumab|Atezolizumab 1200 mg IV over 60 minutes every 3 weeks. (if first dose is tolerated, all subsequent infusions may be delivered over 30 minutes)
15815393|NCT04322643|Drug|Durvalumab|Durvalumab 10 mg/kg IV over 60 minutes every 2 weeks.
15815394|NCT04322643|Drug|Nivolumab|Nivolumab 480mg IV over 30 minutes every 4 weeks
15815395|NCT04322643|Drug|Avelumab|Avelumab 800 mg IV over 60 minutes every 2 weeks
15815396|NCT04322630|Other|Change in Soluble MER Concentration|Measuring change in soluble MER Concentration post compared to pre bypass for each patient.
15815397|NCT04322604|Drug|lirentelimab (AK002)|Lirentelimab (AK002) is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
15815398|NCT04322604|Other|Placebo|Placebo
15815399|NCT04322565|Drug|Colchicine|Cochicine 1mg/day
15815400|NCT04322552|Drug|Apatinib Mesylate|Apatinib at a dosage of will be administered daily from on D5 through D16
15815401|NCT04322552|Drug|Digoxin tablet|Digoxin at a dosage of 0.25mg will be administered at day 1 and day 12
15815402|NCT04322539|Drug|Fruquintinib|Oral VEGFR inhibitor
15815403|NCT04322539|Drug|Placebo|Placebo capsule
15815404|NCT04322526|Drug|Naltrexone 50 Mg Oral Tablet|Naltrexone hydrochloride (ReVia®. Toronto, ON: Teva Canada Limited; 2015) (onset of action: ≥15 minutes; peak effect: ~1 hour; duration: ~24 hours).
15815405|NCT04322526|Drug|Placebo oral tablet|Placebo tablet that has no inherent power to produce an effect. In the inert pill condition, participants will receive an oral placebo tablet.
15815407|NCT04322500|Dietary Supplement|probiotics|use specific probiotics in addiction to conservative treatment to modify the intestinal microbiome to ameliorate the clinical course of chalaziosis in children by re-establishing intestinal and immune homeostasis
15815408|NCT04322500|Other|conservative treatment|lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days
15815409|NCT04322487|Diagnostic Test|Lung ultrasound|A proposal of a standardized approach in order to optimize the use of lung ultrasound in COVID-19 patients. We focus on equipment, procedure, classification and data-sharing.
15815410|NCT04322474|Device|Catheter-based left atrial appendage occlusion|Catheter-based implantation of left atrial appendage occluder
15815411|NCT04322461|Dietary Supplement|Betaquik MCT supplement|50g/day divided in 3. Breakfast, lunch and dinner
15815412|NCT04322448|Device|Mechanomyography (MMG)|MMG, as described in the cohort descriptions, to be used during surgery to see if they are predictive of patient outcomes.
15815413|NCT04322435|Other|Continuous blood glucose measurement|Continuous blood glucose measurement with Abbott Freestyle Pro for 14 days, repeated twice at 6 months intervals.
15815414|NCT04322435|Other|Measurement of capillary blood glucose|"Measurement of capillary blood glucose :
~In the morning on an empty stomach, every first week of each month for 12 months.
~In case of suspicion of hypoglycaemia (parental assessment). Abbott's Freestyle optium neo reader, used with the Accu-Chek FastClix lancing device and the Accu-Chek Performa strips."
15815415|NCT04322422|Drug|Inhaled corticosteriod/long-acting beta-agonist plus Montelukast|Inhaled corticosteriod/long-acting beta-agonist are regular inhaled drugs for classic asthma; Montelukast is benefitial for allergic disease
15815416|NCT04322422|Drug|Inhaled corticosteriod/long-acting beta-agonist only|Inhaled corticosteriod/long-acting beta-agonist are regular inhaled drugs for classic asthma
15815417|NCT04322409|Device|Neuromuscular Electrical Stimulation|"5 sessions that consist of NMES over the peroneus longus muscle. This consists of a biphasic current with a phase duration of 240us delivered in a frequency of 75 pules per second, with a ramp-up time of 2-seconds, followed by a 50-s rest period (no stimulation). Each cycle will consist of 10 seconds of on time, and 50 seconds off, with 10 cycles being performed each session."
15815418|NCT04322409|Device|Transcutaneous Electrical Nerve Stimulation|5 sessions that consist of 11-minutes of TENS over the skin of the peroneus longus. This consists of a biphasic current will be continuously applied at 100 pulses per second, with a phase duration of 100us for 10 minutes. The intensity will be turned up until the point the subjects feel the current (sensory threshold)
15815419|NCT04322396|Drug|Azithromycin|Azithromycin
15815420|NCT04322396|Drug|Hydroxychloroquine|Hydroxychloroquine
15815421|NCT04322396|Drug|Placebo oral tablet|Placebo Azithromycin
15815422|NCT04322396|Drug|Placebo oral tablet|Placebo Hydroxychloroquine
15815423|NCT04322383|Drug|binimetinib|Binimetinib will be given orally at a dose of 45mg BID continuously for 28-day cycles with no resting period between cycles.
15816066|NCT04316923|Diagnostic Test|ECG|ECG will be performed during each visit in the study group.
15815424|NCT04322370|Procedure|Standard of Care Surgical Procedure|Zone 2 Flexor Tendon surgical repair will be performed by the principal investigator per standard of care. The same technique of tendon repair will be performed for all patients.
15815425|NCT04322370|Device|VersaWrap Treatment|is intended to manage and protect tendon injuries where there is no significant loss of tendon tissue
15815426|NCT04322357|Drug|Prednisone|A 12-month treatment period with two weekend days of prednisone (dose of 0.75 mg/kg per day).
15815427|NCT04322357|Behavioral|In-home Exercise Training|Six month in-home exercise training program involving a combination of aerobic and isometric leg strength exercises.
15815428|NCT04322344|Drug|Escin|treatment with escin or escinate sodium
15815429|NCT04322344|Drug|standard therapy|antiviral drugs
15815430|NCT04322331|Other|no intervention|no intervention
15815431|NCT04322318|Drug|Carboplatin|Given IV
15815432|NCT04322318|Drug|Cyclophosphamide|Given IV
15815433|NCT04322318|Drug|Doxorubicin|Given IV
15815434|NCT04322318|Drug|Etoposide|Given IV
15815435|NCT04322318|Drug|Ifosfamide|Given IV
15815436|NCT04322318|Drug|Irinotecan|Given IV
15815437|NCT04322318|Drug|Topotecan|Given IV
15815438|NCT04322318|Drug|Vincristine|Given IV
15815439|NCT04322305|Drug|Pregabalin|Pregabalin will be provided in 75 and 100 mg capsules twice daily for a maximum dose of 600 mg/day or the maximum tolerated dose over the 8 week medication phase and followed by a one week taper.
15815440|NCT04322305|Other|Placebo|Placebo capsules will be provided twice daily over 8 weeks and one week taper..
15815441|NCT04322292|Drug|C-CAR088|"Autologous BCMA-directed CAR-T cells, single infusion intravenously at a target dose of 1.0-9.0 x 10^6 anti-BCMA CAR+T cells/kg.
~Divided into three dose ranges of low(1.0-3.0×10^6 CAR+T cells/kg),medium(3.0-6.0×10^6 CAR+T cells/kg) and high(6.0-9.0×10^6 CAR+T cells/kg).
~Other Name: CBM.BCMA Chimeric Antigen Receptor T cell."
15815442|NCT04322279|Diagnostic Test|Serology|SARS-CoV-2 serology
15815443|NCT04322279|Genetic|Sequencing|Whole exome sequencing
15815444|NCT04322266|Drug|HCP1701|Ezetimibe / Rosuvastatin / Amlodipine / Losartan potassium
15815445|NCT04322266|Drug|HCP1306|Ezetimibe /Rosuvastatin
15815446|NCT04322266|Drug|HGP0904|Amlodipine
15815447|NCT04322266|Drug|HGP0608|Losartan potassium
15815448|NCT04322253|Drug|Neladenoson bialanate (BAY 1067197)|10 mg as a single IR tablet dose. Active metabolite: BAY 84-3174
15815449|NCT04322240|Drug|Alpha lipoic acid|Participants will be prescribed 600 mg/day ALA (thiotacid) orally, for 3 months, and will be advised not to discontinue this medication
15815450|NCT04322227|Drug|Foliglurax 10 mg (treatment A)|Foliglurax 10 mg, (BID) capsules, orally
15815451|NCT04322227|Drug|Foliglurax 30 mg (treatment B)|Foliglurax 30 mg, BID capsules, orally
15815452|NCT04322227|Drug|Placebo (treatment C)|Placebo, BID capsules, orally
15815453|NCT04322214|Drug|Cobicistat 150 MG|once daily cobicistat (150 mg QD) for 5 days
15815454|NCT04322214|Drug|Placebo|once daily lactose capsules (as aspect cobicistat capsules)
15815455|NCT04322214|Drug|GHB|single oral dose of GHB (25 mg/kg) on days 5 and 17
15815456|NCT04322201|Device|continuous drainage of ascitic fluid using an intra-abdominal double lumen central venous catheter|Ultrasound-guided placement of an intra-abdominal double lumen central venous catheter, using aseptic Seldinger technique, for continuous drainage of ascitic fluid up to 7 days in Intensive Care
15815457|NCT04322201|Procedure|Ultrasound-guided intermittent large-volume paracentesis|Ultrasound-guided intermittent large-volume paracentesis through 14 Gauge catheter
15815458|NCT04322175|Drug|Meloxicam|Meloxicam Eye Drops
15815459|NCT04322162|Other|ASAP Intervention Quality Improvement Protocol|The intervention program includes: (1) a systems redesign Virtual Collaborative, and; (2) data monitoring and is designed to aid each of the 6 participating VAMCs in developing, implementing, and evaluating the implementation of an acute OSA testing and treatment protocol for ischemic stroke/TIA patients. The sites will choose a diagnostic strategy (i.e., unattended polysomnography [PSG]/home sleep test [HST], in-laboratory PSG, direct to auto-titrating [auto]-PAP) and a therapeutic strategy (i.e., in-laboratory PAP titration, auto-PAP). The intervention will employ 4 implementation strategies: (1) local adaptation; (2) champions; (3) external facilitation, and; (4) audit and feedback.
15815460|NCT04322149|Drug|AT-1501|AT-1501 monoclonal antibody targeting CD40L given as an IV infusion
15815461|NCT04322136|Procedure|Pleurodesis via Video-assisted thoracoscopic surgery|Video-assisted thoracoscopic surgery is a type of key-hole surgery performed under general anaesthetic and usually single lung ventilation by a cardio-thoracic surgeon. This is expected to take about 1 hour. Between one and three ports are used to insert a camera and instruments into the chest cavity. Adhesions can be broken down if present and the lining of the lung (visceral pleura) can sometimes be removed (decortication) to facilitate lung re-expansion. The surgeon can then perform either mechanical abrasion or talc poudrage to induce inflammation and subsequent pleurodesis. A chest drain is left in situ post-operatively and is removed when the fluid draining is below a certain volume depending on local practice.
15815462|NCT04322136|Device|Indwelling pleural catheter (with talc pleurodesis if suitable)|Once the indwelling pleural catheter is inserted, the pleural fluid will be evacuated as completely as possible. If the lung fully re-expands, 4-5g of sterile graded talc will be instilled via the IPC. The participant will then be discharged on a daily drainage regimen for 14 days. At review in clinic on day 14, the participant will be assessed for spontaneous pleurodesis (<50ml drainage on 3 consecutive drainage attempts). If pleurodesis has occurred and there is no residual symptomatic effusion, arrangements will be made for IPC removal. Otherwise the participant will switch to a symptom-guided drainage regimen. If the lung does not fully re-expand following complete fluid evacuation, they will be discharged on a symptom-guided regimen without instillation of talc. The drainage regimen will continue for the duration of the study and beyond if pleurodesis has not occurred and pleural fluid continues to accumulate.
15815463|NCT04322123|Drug|Hydroxychloroquine Oral Product|Hydroxychloroquine 400 mg BID
15815464|NCT04322123|Drug|Hydroxychloroquine + azithromycin|Hydroxychloroquine 400 mg BID + azithromycin 500 mg once a day
15815465|NCT04322110|Other|PronoKal Method|Multidisciplinary program of weight loss based on diet (initially ketogenic diet), physical activity and emotional support
15816067|NCT04316923|Diagnostic Test|24-hour ECG monitoring|24-hour ECG monitoring will be performed during each visit in the study group.
15815466|NCT04322110|Other|Low calorie diet|Balanced hypocaloric diet (caloric intake 10% below basal metabolic rate) accompanied by physical exercise.
15815467|NCT04322097|Device|Lingual Muscle Stimulation|Tongue protrudor and retractor muscles will be stimulated separately and in combination
15815468|NCT04322097|Diagnostic Test|Mandibular advancement|Outcome variables will be assess with and without mandibular advancement
15815469|NCT04322097|Device|Postural maneuvers|Outcome variables will be measured with and without postural maneuvers
15815471|NCT04322071|Other|Interview|Qualitative interviews only
15815472|NCT04322058|Other|The Dads' Club|The core intervention is Core 24/7 workshop attendance
15815473|NCT04322045|Diagnostic Test|multi-parametric MRI|Multi-parametric MRI will be suggested for those PSA ≥4 ng/mL, PI-RADS v2 score will be used to evaluate images.
15815474|NCT04322032|Drug|Reference drug|D759 Tab. 1 Tab. and D308 Tab. 1 Tab.(Total 2 Tab.), Single oral administration under fasting condition.
15815475|NCT04322032|Drug|Test drug|CKD-389 Tab. 1 Tab.(Total 1 Tab.), Single oral administration under fasting condition.
15815476|NCT04322019|Other|Data record|Data record
15815477|NCT04322006|Drug|PD-1 monoclonal antibody injection|15mg/kg~20mg/kg TJ004309 Injection in combination with PD-1 monoclonal antibody injection every 2 weeks for a treatment cycle every 28 days
15815478|NCT04322006|Drug|TJ004309 Injection|2mg/kg~20mg/kg TJ004309 Injection is administered once a week for a treatment cycle every 28 days
15815479|NCT04321993|Drug|Baricitinib (janus kinase inhibitor)|Baricitinib 2 mg po daily for 10 days
15815480|NCT04321980|Drug|OP-101|Subcutaneous injection of OP-101 in healthy volunteers
15815481|NCT04321967|Drug|Nitroglycerin Paste|1g of 2% Nitroglycerin paste topical application
15815482|NCT04321967|Drug|Dermabond|Topical skin adhesive
15815483|NCT04321954|Drug|LENVATINIB|Orally
15815484|NCT04321941|Diagnostic Test|Lumentin|Contrast agent used in combination with CTE
15815485|NCT04321941|Diagnostic Test|Movprep|Contrast agent used in combination with MRE
15815486|NCT04321928|Behavioral|Personalized health education|Subjects will go through questioning and recommendations in 5 domains: (1) mental health (2) smoking habits, (3) physical activity, (4) dietary habits and (5) alcohol consumption. Then they will receive detailed individualized education regarding lifestyle changes based on their current habits.
15815487|NCT04321928|Behavioral|General health education|Subjects will go through questioning and recommendations in 5 domains: (1) mental health (2) smoking habits, (3) physical activity, (4) dietary habits and (5) alcohol consumption. Then they will receive general health education aiming towards improvement of these factors with general recommendations following the WHO principles.
15815490|NCT04321902|Procedure|Laparoscopic cholecystectomy|"Method of operation
~Surgery was started under general anesthesia
~A trocar of 10 mm was placed on the navel, 5 mm under the blade, and 5 mm trocar was placed on the right upper abdomen.
~Pneumoperitoneum was performed using CO2 gas in the abdominal cavity.
~Dissection started from Calot's triangle and the operation was performed by retrograde cholecystectomy.
~The excised gallbladder was placed in a laparoscopic pocket and extracted through the umbilicus.
~The trocar was removed and the skin was sutured
~On the 1st day after surgery, hematology, blood chemistry, urine, blood clotting, and chest x-rays were performed. (Inspection and treatment were performed according to the current clinical pathway of gallbladder surgery)"
15815491|NCT04321889|Device|defurocumarinized bergamot loaded in a nanotechnological essential oil release system|Patients will be treated either with placebo cream or with defurocumarinized bergamot loaded in a nanotechnological system of essential oil release in the pharmaceutical form of cream 2 times a day for 4 weeks. The subject will be monitored throughout the treatment and for at least 4 weeks after the end of the treatment.
15815492|NCT04321889|Other|Placebo|nanotechnological system loaded with placebo cream
15815493|NCT04321876|Behavioral|Collaborative Behavioral Health Program|Collaborative care is the delivery of mental health care through a proactive collaboration of primary care providers, behavioral care managers based in primary care practices, and psychiatrists who provide supervision to the behavioral care managers and consultation to the primary care providers.
15815494|NCT04321863|Other|Faecal calprotectin (FC)|FC is a surrogate marker of neutrophil influx into the gut lumen. It accurately predicts mucosal healing (MH) at colonoscopy, and thus is already widely used in clinical practice in disease monitoring in CD patients (standard of care).
15815495|NCT04321863|Other|quantitative Faecal Immunochemical Testing (qFIT)|Stool test for haemoglobin. It has been shown to predict mucosal healing in Crohn's disease and ulcerative colitis. This study will compare the ability of qFIT and FC to predict flare in CD (qFIT is a cheaper, more stable test with a quicker turn-around time than FC, and is also less labour intensive for the lab).
15815496|NCT04321863|Other|Serum and faecal zinc|Blood sample for serum zinc will be taken at same time as routine (standard of care) monitoring bloods which include CRP - no additional venipuncture will be required. A single stool sample will be sufficient to measure FC (as outlines above) and faecal zinc. This study will compare the ability of serum/faecal zinc and CRP at predicting relapse in patients with quiescent (inactive) luminal (affecting the small and/or large bowel) CD.
15815497|NCT04321850|Drug|Zinc Sulfate 50 Mg Tab|The tablets were manufactured specifically for this study.
15815498|NCT04321850|Drug|Placebo oral tablet|The tablets were manufactured specifically for this study.
15815499|NCT04321837|Dietary Supplement|Coral Complex 3|Coral-derived calcium supplement fortified with vitamin D3
15815500|NCT04321837|Drug|Ibandronate|Bisphosphonate
15815501|NCT04321837|Dietary Supplement|Vitamin D3|Oral vitamin D3
15816967|NCT04309799|Device|Tear Restore Mask|The Tear Restore Mask will be used for 10 minutes
15815502|NCT04321811|Other|Observation of patients with known, suspected, or at risk for COVID-19 infection|Participants will receive daily diary surveys to track the symptomatic course of known or suspected COVID-19 patients as well as use of any interventions or treatments.
15815503|NCT04321798|Behavioral|Physical Activity|Four group sessions and one individual session delivered over a period of 12 weeks in a primary care setting. Each session includes patient education and support for behaviour change as well as a supervised practical exercise component. The intervention is based upon a combination of self-determination theory and COM-B framework (capability, opportunity, motivation and behaviour) and employs motivational interviewing techniques.
15815504|NCT04321785|Other|Placebo|placebo capsule (mannitol)
15815505|NCT04321785|Other|Caffeine|caffeine capsule (80 mg of caffeine plus mannitol)
15815506|NCT04321772|Other|High Intensity Interval Resistance Training|Subjects trained one leg with HIIRT
15815507|NCT04321772|Other|Traditional Resistance Training|Subjects trained the other leg with HIIRT
15815508|NCT04321759|Behavioral|Cognitive Enhancement Therapy|CET's group-based exercises are delivered for 1.5 hours each week in a group of 6-8 participants led by a clinician and an assistant, for one year. During each of three modules (basic concepts, social cognition, CET applications), the groups focus on acquisition of adult social milestones in perspective-taking, social context appraisal, and other aspects of social cognition, with psychoeducational lectures, homework assignments, and in-group exercises. Weekly supervision sessions for the clinician trainers will include review of how patients respond to the different demands of computer-based training and group-based exercises and guidance about improving engagement in both.
15815509|NCT04321759|Behavioral|Social Skills Training|"The psychosocial component involves weekly skills training classes delivered over one year, with modules including Communicating Effectively, Making and Keeping Friends, Making the Most of Leisure Time, Healthy Living, Using Medications Effectively, and Making the Most of a Health Care Visit (Pratt et al., 2008). Participants attend two sessions each week (normally morning and afternoon of the same day): a 90-minute session focused on a specific skill and a 60-minute session in which the specific skill is used in role-play exercises."
15815510|NCT04321746|Drug|Ketamine|ketamine will be administered at a dose of 0.3 mg/kg in normal saline at 0.9% (250 mL)
15815511|NCT04321746|Other|Placebo|the control group will receive only normal saline at 0.9%, with the same physical characteristics of the ketamine solution
15815512|NCT04321733|Drug|Amoxicillin Clavulanate|Intravenous drug intake of our drug.
15815513|NCT04321720|Other|3-g mustard footbath|A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C) and 36 g mustard flour (3 g per l), followed by a ten-minute post-intervention rest period.
15815514|NCT04321720|Other|6-g mustard footbath|A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C) and 72 g mustard flour (6 g per l), followed by a ten-minute post-intervention rest period.
15815515|NCT04321720|Other|12-g mustard footbath|A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C) and 144 g mustard flour (12 g per l), followed by a ten-minute post-intervention rest period.
15815516|NCT04321720|Other|Warm water only|A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C), followed by a ten-minute post-intervention rest period.
15815517|NCT04321707|Radiation|15O-H2O PET/MR|All included patients will have a 15O-H2O PET/MR scan performed at baseline and a scan performed after NAC, prior to cystectomy.
15815518|NCT04321694|Drug|KHK2455|
15815519|NCT04321681|Other|no intervention|no intervention
15815520|NCT04321668|Device|Synvisc-One|SYNVISC-ONE® (Hylan G-F 20), 10 mL single-injection viscosupplement Status : CE marked (CE 0086) class III Medical Device The IP is used according to its usual dosage, administration and indication
15815521|NCT04321655|Other|High Intensity LASER Therapy (HILT)|"The total energy will be delivered to the patient during one session will be 1,250 J through three phases of treatment.
~Initial phase (710 and 810 mJ (millijoule)/cm2 for a total of 500 J)
~Intermediate phase (handpiece will be applied on the joint line just proximal to the medial and lateral tibial condyles with 25 J, a fluency of 610 mJ/cm2, and a time of 14 s for each point and a total of 250 J)
~Final phase (same as the initial phase (500 J) except that scanning will be slow manual scanning ) The application time for all three phases will be approximately 15 min with the total energy delivered to the patient during one session of 1,250 J"
15815522|NCT04321655|Other|Ibuprofen Gel Phonophoresis (IGP)|Continuous ultrasound set at a frequency of 1 MHz and an intensity of 1 W/cm2 was applied on a circular basis. (8 min/ one session each day for 3 days/week for 8 weeks).
15815523|NCT04321655|Other|Transcranial Direct Current Stimulation (tDCS)|Anode electrode -C3/C4 (contralateral side of the most affected knee), Cathode electrode- contralateral supraorbital area. (2 mA intensity for 20 minutes, one session/day for 3 days/week for 8 weeks)
15815524|NCT04321655|Other|Conventional Physiotherapy (CPT)|"Warm-up exercises: Walking at the usual speed on a flat surface for 10 min ( 3sets X10 Reps X 3 min rest in between)
~Hamstring and calf gentle stretches. ( 3sets X10 Reps X 3 min rest in between)
~Straight leg raise (SLR) ( 3sets X10 Reps X 3 min rest in between)
~Quadriceps setting ( 3sets X10 Reps X 3 min rest in between)
~Pillow squeeze ( 3sets X10 Reps X 3 min rest in between)
~Heel raise ( 3sets X10 Reps X 3 min rest in between)
~One leg balance ( 3sets X10 Reps X 3 min rest in between)
~Step ups ( 3sets X10 Reps X 3 min rest in between)
~Quadriceps strengthening exercises ( 3sets X10 Reps X 3 min rest in between)"
15815525|NCT04321642|Drug|Entonox|Entonox gas with mouth piece
15815526|NCT04321642|Drug|Not receive Entonox|Not receive any gas
15815527|NCT04321629|Combination Product|autologous adipose tissue transfer|experimental group: liposuction, adipose tissue preparation and intra-articular injection
15815528|NCT04321629|Combination Product|PRP injections|control group: blood collection, blood preparation and intra-articular PRP injection
15815529|NCT04321616|Drug|Hydroxychloroquine|Hydroxychloroquine will be given orally (in the ICU in gastrointestinal tubes) with 800 mg x 2 loading dose followed by 400 mg x 2 every day for a total of 10 days.
15815530|NCT04321616|Drug|Remdesivir|Remdesivir will be given intravenously 100 mg daily for the duration of the hospitalization and up to 10 days total course. A loading dose of 200 mg at inclusion will be given.
15815531|NCT04321616|Other|(Standard of Care) SoC|The standard of care will be supplied to all patients not receiving a drug intervention.
15815532|NCT04321603|Behavioral|Walking|Moderately paced walking of approximately 100 steps/minute for 30 minutes three times weekly for six weeks.
15815533|NCT04321590|Dietary Supplement|Combination of oat beta-glucan of different richness (35 and 70%) at low (3g) and high (5g) doses with green coffee bean extract (600 mg)|Dose-response study on the effect of two different types of oat beta-glucan with different b-glucan content (35% vs. 70%) in combination with a green coffee bean extract rich in polyphenols. Consumption of 2 sachets/day (providing 3 or 5 g/d beta-glucan plus 600 mg polyphenols) during 6 weeks
15815534|NCT04321577|Procedure|Radical surgery|Radical surgery is proposed to participants with pT1b, pT2 or pT3 tumors in the cholecystectomy specimen without evidence of disseminated disease with staging imaging techniques. A resection of the gallbladder bed or an anatomic resection of the hepatic segments IVb/V is performed. A lymphadenectomy of the hepatic hilum is associated in all cases. Common bile duct resection is performed in patients with involvement of the cystic margin.
15815535|NCT04321551|Drug|Recombinant follicle-stimulating hormone|Intravenous injection of recombinant follicle-stimulating hormone 150 IU, once.
15815536|NCT04321551|Drug|Estradiol Valerate|Intramuscular injection of estradiol valerate 5 mg, once
15815537|NCT04321551|Drug|Progesterone Injectable|Intramuscular injection of progesterone in oil 50 mg, once
15815538|NCT04321538|Device|Gocheck Kids|GoCheck Kids is a photoscreening device. It takes a special picture of the eyes that allows for detection of refractive error and eye misalignment.
15815539|NCT04321538|Device|Welch Allyn Spot Vision Screener|The Welch Allyn Spot Vision Screener is a photoscreening device. It takes a special picture of the eyes that allows for the detection of refractive error and eye misalignment.
15815540|NCT04321538|Diagnostic Test|Physical Exam|Retinoscopy and an oculomotor testing will constitute the physical examination.
15815541|NCT04321525|Behavioral|Cognitive-behavioral therapy|10 individual one-hour sessions, with one or two booster sessions at about three months after the tenth session
15815542|NCT04321525|Behavioral|Personal Construct Therapy|10 individual one-hour sessions, with one or two booster sessions at about three months after the tenth session
15815543|NCT04321525|Behavioral|Personal Construct Therapy with virtual reality|10 individual one-hour sessions, with one or two booster sessions at about three months after the tenth session
15815544|NCT04321512|Other|There is no intervention given to the subjects|Not appicable
15815545|NCT04321499|Genetic|lung cancer|PCR for SHOX2 and PTGER4
15815546|NCT04321486|Other|The study does not have an intervention, but observe the dementia incidence of the UK disease-free population.|The study does not have an intervention, but observe the dementia incidence of the UK disease-free population.
15815547|NCT04321473|Procedure|PCI on left main|PCI on left main coronary stenosis
15815548|NCT04321460|Drug|LRG-002|Capsules containing live lyophilized probiotic bacteria of Lactobacillus genus
15815549|NCT04321460|Drug|Placebo|Capsules containing placebo
15815550|NCT04321447|Other|Clinical practice guideline for prevention and management of extravasation injury|Implementation of an evidence-based clinical practice guideline and delivery of an educational programme for nurses
15815551|NCT04321434|Other|Hyperoxia|
15815552|NCT04321434|Other|Normoxia|
15815553|NCT04321434|Device|laser Doppler|laser Doppler
15815554|NCT04321421|Other|hyperimmune plasma|administration of hyperimmune plasma at day 1 and based on clinical response on day 3 and 5
15815555|NCT04321408|Drug|Ziconotide Injection|intrathecal analgesia with Ziconotide
15815556|NCT04321395|Drug|Vigabatrin|Vigabatrin - Pill, 500 mg twice daily for 7 days (days 0-6), 1000 mg twice daily for 7 days (days 7-13), 1500 mg twice daily for 10 days (days 14-23), 1000 mg twice daily for 7 days (days 24-30), 500 mg twice daily for 7 days (days 31-37) and will discontinue treatment on day 38.
15815557|NCT04321395|Drug|Placebo oral tablet|Pill, 1 pill twice daily for 7 days (days 0-6), 2 pills twice daily for 7 days (days 7-13), 3 pills twice daily for 10 days (days 14-23), 2 pills twice daily for 7 days (days 24-30), 1 pill twice daily for 7 days (days 31-37) and will discontinue on day 38.
15815558|NCT04321369|Diagnostic Test|Testing Sensitivity for SARS-CoV-2 Virus in Symptomatic Individuals|This is an operational project. Patients will collect a sample from the tongue, nasal cavity and MT and then clinicians will collect a NP sample from the nostril corresponding to each participant's dominant hand.
15815559|NCT04321356|Device|Triathlon PCR TKA|Total Knee Arthroplasty System
15815560|NCT04321356|Device|Triathlon PS TKA|Total Knee Arthroplasty System
15815561|NCT04321356|Device|Persona PCR TKA|Total Knee Arthroplasty System
15815562|NCT04321356|Device|Persona PS TKA|Total Knee Arthroplasty System
15815563|NCT04321343|Drug|PXL065|PXL065 oral tablet
15815564|NCT04321343|Drug|Placebo oral tablet|Placebo oral tablet
15815565|NCT04321330|Drug|Atezolizumab|Atezolizumab 1200 mg will be administered by IV on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit.
15815566|NCT04321317|Other|Measure of body composition by Air Displacement Plethysmography (ADP)|Each patient included will have one measure of body composition by Air Displacement Plethysmography (ADP) during the initial consultation in the referent center for food disorders of Lyon and one year later.
15815567|NCT04321304|Device|Sham transcranial direct current stimulation|Uses weak electrical current (2 mA intensity) at the beginning and the end of a given stimulation period to control for potential placebo-like effects or participant expectation bias.
15815568|NCT04321304|Device|Transcranial direct current stimulation at 2 mA|Uses weak electrical current (2 mA intensity) to either increase or decrease brain excitability and improve functional or cognitive outcomes.
15815569|NCT04321304|Device|Transcranial direct current stimulation at 4 mA|Uses weak electrical current (4 mA intensity) to either increase or decrease brain excitability and improve functional or cognitive outcomes.
15815570|NCT04321291|Other|Generic information leaflet|The information about the biosimiliars is realized only by the transmission of the information leaflet in addition to the information given by the investigator.
15815571|NCT04321291|Other|Individual information by nurse on biosimilars|Delivery of the same information leaflet, completed if asked by the patient, by individual meeting with specialist nurse, including generic and standardized informations on specificities, advantages and current scientific knowledge about biosimilars in inflammatory rheumatic diseases. This is in addition to the information given by the investigator
15815572|NCT04321278|Drug|Hydroxychloroquine + azithromycin|Intervention Group: Hydroxychloroquine + azithromycin. After randomization, Hydroxychloroquine [400mg 2x/day, 12/12h] + azithromycin [500mg 1x/day]) for 10 days. Standard treatment is according to the treatment protocol for 2019-nCoV infection.
15815573|NCT04321278|Drug|Hydroxychloroquine|Active Control Group: Hydroxychloroquine. After randomization, Hydroxychloroquine [400mg 2x/day, 12/12h] for 10 days. Standard treatment is according to the treatment protocol for 2019-nCoV infection.
15815574|NCT04321252|Drug|KAE609|iv administration
15815575|NCT04321252|Drug|Placebo|matching placeo for iv administration
15815576|NCT04321239|Behavioral|Positive STEPS|Individuals in the intervention group will meet with a community health worker at an in-person or virtual study orientation session. At this session, they will be introduced to the program, learn how to use the online modules and any associated materials, and choose a day and time for future weekly telephone sessions. Participants will also be given a wearable physical activity tracker at the orientation session to use throughout the course of the program. They can choose to report daily step counts either by automatically syncing to an app or by manual reporting via text message. The program will be delivered over 6 weeks. Each week participants will complete a web-based module and have one telephone session with the community health worker to discuss that module and to set a related goal. Participants will also set weekly goals related to walking, which will be informed and tracked by daily step-counts from the physical activity tracker.
15815577|NCT04321226|Device|Femtosecond Laser guided Arcuate Keratotomy|Astigmatism will be reduced in cataract surgery using a low energy Femtosecond Laser device
15815578|NCT04321200|Diagnostic Test|PANDA Gym|Infants will lie supine on a flat surface and will be placed in the PANDA gym where they either move by themselves or will interact with an instrumented toy. We will collect video, mat, and toy data from PANDA gym under two conditions: 1) infants playing supine without a toy and 2) infants reach, grasp and kick of the new PANDA toy. A test session will proceed as follows: The infant will be placed on his or her back at a predetermined position on the gym mat for the 2-minute no toy condition. Next, the toy will be given to the baby and adjusted for the infant to reach or kick. A caregiver will be seated at the head of the baby (out of a baby's sight) to provide comfort if needed. Testing will be done in NICU or at daycare or the rehabilitation robotics lab at University of Pennsylvania.
15815579|NCT04321200|Other|Mobile App|"The parent or legal guardian will be consented first via the virtual rounding mobile app. They will also be asked to fill out general surveys including, a demographic survey, and a case report form, and a user feedback survey that provides relevant information, on both the family's and infant's medical history and experience. (see the flow-chart for the app). Within the caregiver survey, we will request the pediatrician (or primary care physician) name. We believe that with the baby name, caregiver name, zip code, and physician name, we will be able to locate the physician if needed.
~Parents or legal guardians or the research will be asked to collect video via the MOBILE app. They will be instructed to ensure that the infant lies supine in no more than one-layer of tight-fitting clothing (i.e. infant onesie) while calm and awake. In all cases, we will have video recordings of the baby. They will be asked to upload the video to the app."
15815580|NCT04321174|Drug|Lopinavir/ritonavir|The intervention is a 14-day course of LPV/r 400/100 mg orally twice daily, or equivalent weight-based dosing, to be initiated as soon as possible (within 1-7 days) after the last exposure.
15815581|NCT04321161|Drug|Bicanorm|"Treatment of patients with relapsed AML after allo-HCT receiving DLIs with Bicanorm (1-1-1) for 7 days.
~sodium hydrogen carbonate (1 g per 1 tablet) = sodium ion (11,9 mmol per 1 tablet) = sodium ion (273 mg per 1 tablet) = hydrogen carbonate ion (11,9 mmol per 1 tablet)"
15815582|NCT04321148|Procedure|standard of care PCI|optimal medical care PCI
15815583|NCT04321148|Procedure|Impella-protected PCI|Impella-protected PCI
15815584|NCT04321135|Behavioral|Guided Lifestyle Program Intervention|The Guided Lifestyle Program will receive sessions that meet twice weekly and 2-3 text messages weekly.They will also receive a participant informational binder (wellness guide) with health and exercise information and tools as directed by ACS nutrition and physical activity guidelines.
15815585|NCT04321135|Behavioral|Self-Guided Lifestyle Program (Control Arm)|In the self-guided weight loss program, participants will be given the sane informational binder with health and exercise information and tools as directed by ACS nutrition and physical activity guidelines but they will not receive in-person classes or text messaging
15815586|NCT04321122|Procedure|ultrasound cyclo plasty|"The ultrasonic glaucoma treatment instrument produced by French EYE TECH CARE company is referred to as EyeOP1.It uses high-intensity focused ultrasound technique to make target part of the ciliary coagulative necrosis, reduce the production of aqueous humor and thereby lower the intraocular pressure. EyeOP1 is ergonomic and suitable for the human eye, making the treatment process more accurate, simple and fast."
15815587|NCT04321109|Other|Allograft|Corticocancellous mineralized allograft
15815588|NCT04321109|Other|Collagen cone|Collagen matrix
15815589|NCT04321096|Drug|Camostat Mesilate|Serine protease inhibitor that blocks TMPRSS-2 mediated cell entry of SARS-CoV-2
15815590|NCT04321096|Drug|Placebo oral tablet|Placebo
15815591|NCT04321083|Diagnostic Test|INVOS|INVOS monitoring brain o2 saturation
15815592|NCT04321070|Drug|Clindamycin Phosphate|A thin film of investigation product will be applied to the affected areas of the face once daily
15815593|NCT04321070|Drug|Clindamycin Phosphate RLD|A thin film of investigation product will be applied to the affected areas of the face once daily
15815594|NCT04321070|Drug|Placebos|A thin film of investigation product will be applied to the affected areas of the face once daily
15815595|NCT04321044|Genetic|Genetic based analysis of identifying predictors of blood pressure in patients after renal denervation|We attempt to idendtify predictors of blood pressure response to renal denervation by using a GWAS (Genome wide association study) approch.
15815599|NCT04321018|Dietary Supplement|Mixed meal with medium chain triglycerides|Mixed macronutrient liquid meal (1.6kcal/ml, 15% protein, 47% carbohydrates, 35% fat, 3% fiber) with medium chain triglycerides (3g/100 kcal). An amount with energy supply equivalent to their 50% basal metabolic rate.
15815695|NCT04320069|Device|Omnipod Horizon™ Automated Glucose Control System|Omnipod Horizon™ Automated Glucose Control System use in Manual Mode
15817140|NCT04308434|Other|CSD190601-17|Flavor variant CSD190601-17 of a 1.5% nicotine ENDS product
15815600|NCT04321018|Dietary Supplement|Mixed meal with the replacement of medium chain triglycerides with unsaturated tryglicerides|Mixed macronutrient liquid meal (1.6kcal/ml, 15% protein, 47% carbohydrates, 35% fat, 3% fiber) without medium chain triglycerides (replaced it with long chain triglycerides). An amount with energy supply equivalent to their 50% basal metabolic rate.
15815601|NCT04321005|Procedure|arthroscopic rotator cuff reconstruction|arthroscopic rotator cuff reconstruction and assessment with evaluation and prediction of core outcomes
15815602|NCT04320979|Radiation|internal mammary nodal irradiation|chest wall and supraclavicular +-axillary plus internal mammary nodal irradiation (50 Gy in 25 fractions or 43.5Gy in 15 fractions).
15815603|NCT04320979|Radiation|no internal mammary nodal irradiation|chest wall and supraclavicular+-axillary nodal irradiation (50 Gy in 25 fractions or 43.5Gy in 15 fractions).
15815604|NCT04320953|Device|Non-contact MCE system|After an overnight fasting and drinking 1000 mL water and simethicone for gastric dilatation and preparation, the study subject positions himself (herself) on the examination bed in Room A, while the operating doctor sits in Room B at the remote control workstation instructing her to swallow the capsule via the audio-visual exchange system. After the capsule entering the stomach, the doctor manipulated the two joysticks on the remote control workstation, mobilizing the robotic magnetic arm, and simultaneously driving the precise movement and rotation of the capsule to perform the gastric examination.
15815605|NCT04320940|Drug|Phenobarbital Sodium Injection|The initial dose will be administered intravenously over a 30-minute period. The time period between the first and second dose of phenobarbital cannot occur within 30 minutes of the end of the first dose.
15815606|NCT04320914|Other|High Intensity LASER Therapy|"The total energy will be delivered to the patient during one session will be 1,250 J through three phases of treatment.
~Initial phase (710 and 810 mJ/cm2 for a total of 500 J)
~Intermediate phase (handpiece will be applied on the joint line just proximal to the medial and lateral tibial condyles with 25 J, a fluency of 610 mJ/cm2, and a time of 14 s for each point and a total of 250 J)
~Final phase (same as the initial phase (500 J) except that scanning will be slow manual scanning ) The application time for all three phases will be approximately 15 min with the total energy delivered to the patient during one session of 1,250 J Duration of the treatment will be 8 minutes in one session/knee joint for each day for 3 days/week for 8 weeks."
15815607|NCT04320914|Other|Ibuprofen gel phonophoresis|Continuous ultrasound set at a frequency of 1 MHz and an intensity of 1 W/cm2 was applied on a circular basis. Each treatment session will last for 8 min with one session each day for 3 days/week for 8 weeks.
15815608|NCT04320901|Device|Ligasure|Ligasure™ Maryland Jaw Laparoscopic Sealer/Divider 37cm
15815609|NCT04320901|Device|Harmonic|Harmonic ACE 7+
15815611|NCT04320875|Other|Transcranial direct current stimulation|Anode electrode -C3/C4 (International 10-20 electroencephalogram system), contralateral side of the most affected knee) Cathode electrode- contralateral supraorbital area. 2 mA intensity for 20 minutes, one session/day for 3 days/week for 8 weeks)
15815612|NCT04320875|Other|Conventional Physiotherapy|"Warm-up exercises: Walking at the usual speed on a flat surface for 10 min ( 3sets X10 Reps X 3 min rest in between)
~Hamstring and calf gentle stretches. ( 3sets X10 Reps X 3 min rest in between)
~Straight leg raise (SLR) ( 3sets X10 Reps X 3 min rest in between)
~Quadriceps setting ( 3sets X10 Reps X 3 min rest in between)
~Pillow squeeze ( 3sets X10 Reps X 3 min rest in between)
~Heel raise ( 3sets X10 Reps X 3 min rest in between)
~One leg balance ( 3sets X10 Reps X 3 min rest in between)
~Step ups ( 3sets X10 Reps X 3 min rest in between)
~Quadriceps strengthening exercises ( 3sets X10 Reps X 3 min rest in between)"
15815613|NCT04320836|Procedure|Cervical epidural steroid injection|Interlaminar cervical epidural steroid injection with steroid and normal saline at C6-7 and C7-T1 (standard of care).
15815614|NCT04320823|Device|Updated Plasma Collection Feature|Plasma collection using a novel, patented system that supports a more individualized collection approach.
15815615|NCT04320823|Device|Current Plasma Collection Approach|Plasma collection using the current collection approach.
15815616|NCT04320810|Other|no intervention|It's only observational study. No interventions.
15815617|NCT04320797|Diagnostic Test|Flow cytometry analysis of urine samples|"Urine samples will be conserved and frozen upon arrival. All samples will be stained according to T cell and TEC (tubular epithelial cells) panel with fluorochromes.
~T cell panel: CD3, CD4, CD8, CCR7, CD45RO, CD28, CD279; TEC panel: vimentin, cytokeratine, CD10, CD13, CD227, CD326"
15815618|NCT04320784|Other|Time restricted eating|TRE group consumed 100% of its estimated daily energy needs in an 8-hour time window: from 10:00 AM to 6:00 PM
15815619|NCT04320784|Other|Control|CTRL group consumed 100% of its estimated daily energy needs in 3 meals between 7:00 AM and 9:00 PM
15815620|NCT04320771|Drug|Neladenoson bialanate (BAY 1067197)|10 mg as a single IR tablet dose. Active metabolite: BAY 84-3174
15815621|NCT04320758|Other|conventional preparation design|chamfer finish line
15815622|NCT04320758|Other|biologically oriented preparation technique|shoulder less preparation design
15815623|NCT04320745|Drug|Androderm®|Nightly Transdermal dose of Androderm® of either 2 mg/day, 4 mg/day, or 6 mg/day.
15815624|NCT04320732|Behavioral|Observation of behavior and COVID-19 infection will be conducted.|No intervention, only prospective observation of behavior will be conducted by a questionnaire.
15815625|NCT04320706|Drug|Oral Oxytocin|Administration of oxytocin (24 international units) orally
15815626|NCT04320706|Drug|Oral Placebo|Administration of placebo orally
15815627|NCT04320693|Drug|IMMU-132|IMMU-132 will be administered as an intravenous infusion on Days 1 and 8 of 21-day treatment cycles
15815628|NCT04320680|Other|description of a lupus patient cohort|description of a lupus patient cohort
15815629|NCT04320667|Diagnostic Test|Flow cytometry analysis of urine samples|"Urine samples will be conserved and frozen upon arrival. All samples will be stained according to T cell and TEC (tubular epithelial cells) panel with fluorochromes.
~T cell panel: CD3, CD4, CD8, CCR7, CD45RO, CD28, CD279; TEC panel: vimentin, cytokeratine, CD10, CD13, CD227, CD326"
15815630|NCT04320654|Other|exercise|The aim of this intervention is to increase patients average daily step count. The walking program is a behavior change intervention in which the pedometer will be used as a tool to help the patients monitor their activity levels.
15815896|NCT04318392|Other|Blood sampling and storage of plasma for metabolomic analysis|Blood sampling and storage of plasma for metabolomic analysis will take place during each study visit.
15815631|NCT04320641|Other|ACUPRESSURE|Acupressure points were determined in a certain order considering the direction of the meridian. The order of application was in the form of Spleen 6th point (SP 6) and 4 point of the Large Intestine (Li 4). In total, 4 points in the upper / lower extremities and 6 acupressure points along with parallel points were studied in each attempt.
15815632|NCT04320628|Device|AnaSept®|AnaSept® AnaSept® Antimicrobial Skin and Wound Cleanser is a clear liquid consisting of 0.057% sodium hypochlorite (NaOCl) in an isotonic saline. It has a broad-spectrum of antimicrobial action inhibiting the growth of Staphlyococcus aureus, Psuedomonas aeruginosa, Escherichia coli, Proteus mirabilis, Serratia marcescens, Clostridium difficile, including antibiotic resistant Methicillin Resistant Staphylococcus aureus (MRSA), Vancomycin Resistant Enterococcus faecalis (VRE), Carbapenem Resistant E.coli (CRE) and Acinetobacter baumannii, that are commonly found in wound bed as well as fungi such as Candida albicans and Aspergillus niger. However, NaOCL is non-toxic to mammalian cells.
15815633|NCT04320628|Other|NSS|NSS
15815634|NCT04320615|Drug|Tocilizumab (TCZ)|Participants will receive 1 dose of IV TCZ. 1 additional dose may be given if clinical symptoms worsen or show no improvement.
15815635|NCT04320615|Drug|Placebo|Participants will receive 1 dose of IV placebo matched to TCZ. Up to 1 additional dose may be given if clinical symptoms worsen or show no improvement.
15815636|NCT04320602|Biological|Eculizumab|Participants must have been prescribed and be receiving a stable dose of eculizumab 1200 milligrams (mg) every 2 weeks (q2w) for at least 3 months prior to the Screening Period. During the Screening Period, participants will continue to receive eculizumab 1200 mg q2w.
15815637|NCT04320602|Biological|Ravulizumab|During the Treatment Period, participants will receive a loading dose of ravulizumab on Day 1, followed by maintenance doses on Day 15 and every 8 weeks, administered by intravenous infusion. Ravulizumab loading and maintenance doses will be based on participants' body weight per approved dose regimen.
15815638|NCT04320589|Drug|Dexmedetomidine|which in addition to the orally prescribed drugs; on admission to the ICU, the Pheo-patient has serum-Mg level measurement & a bolus of 40 mg/kg MgSo₄ is given I.V. & may be repeated until the therapeutic level of MgSo₄ 2-4 mmol/Liter is reached (7&10). Dexmedetomidine sedation is started the evening prior to surgery by loading dose of 1µg/Kg followed by 0.2-0.7 µg/Kg/hour according to each patient
15815639|NCT04320589|Drug|General anesthetic|1) Traditional group in which the patients̕ hemodynamic adjustment will be conducted using orally or IV α₁ & β-adrenergic blockers [Prazocin (minipress): 0.5-20 mg/day, Propranolol (Inderal) :10-360 mg/day, Bisoprolol (Concor): 2.5-20 mg/day, Atenolol (Tenormin): 25-100 mg/day &/or Labetalol (Trandate)200-600 mg/day, ACI & ACRB e.g. Tritace 2.5-10 mg/day & Atacand 4-16 mg/day]
15815640|NCT04320576|Device|Bulk-fill|Bulk-fill resin composite (bulk technique)
15815641|NCT04320576|Device|Nano-fill|Nano-fill resin composite (layering technique)
15815642|NCT04320563|Procedure|Rexon-eye|This treatment involved the technology known as quantum molecular resonance (QMR) which has emerged as a new treatment for all types of dry eyes.
15815643|NCT04320550|Diagnostic Test|abdominal ultra sound|non invasive tests to exclude pathological causes
15815644|NCT04320537|Other|abstinence from use of marijuana and other abused drugs|abstinence from use of marijuana use and other abused drugs
15815645|NCT04320524|Device|Technology-Assisted Respimat Adherence Digital Behaviour Change Intervention|3 weeks
15815646|NCT04320511|Device|CT-V|CT-V is an image processing-based modality that recovers changes in local tissue volumes, induced by respiratory motion, from an inspiration-expiration CT (IE-CT) scan or a standard non-contrast 4D CT scan
15815647|NCT04320498|Biological|prp injection|PRP was injected locally in the anal fissure area and glyceryl trinitrate was administered twice daily in the perianal region as in the control group.
15815648|NCT04320498|Drug|Anrecta|self-administered topical glyceryl trinitrate (anrecta), in the perianal area twice a day
15815649|NCT04320498|Behavioral|sitz bath|participants were told to take a hot water sitz bath once a day
15815650|NCT04320498|Dietary Supplement|nutrition regulation|The study participants were told to eat a fiber-rich diet and to drink least 2 liters of water daily
15815651|NCT04320485|Diagnostic Test|Active Anthrax Detect™ Plus (AAD Plus)|A lateral flow immunoassay rapid test (AAD Plus) for early and presumptive diagnosis of inhalational anthrax.
15815652|NCT04320472|Other|Follow up|Follow up up to day 90 (Glasgow outcome scale, Glasgow outcome scale extended, functionnal impairments : Barthel index, Disability Rating Scale)
15815653|NCT04320459|Diagnostic Test|Bath Ankylosing Spondylitis Metrology Index (BASMI)|It characterises the spinal mobility of patients with ankylosing spondylitis. Cervical rotation, tragus-wall distance, lateral lumbar flexion, anterior lumbar flexion (modified schober), intermalleolar distance were measured. The total score of the 5 measurements was taken, the score range was 0-10, the low score meant that the spinal movement was better.
15815654|NCT04320459|Diagnostic Test|Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)|It assess the disease activity. It was evaluated with a 6-question questionnaire. After taking the answer of each question out of 10, the total of the points was calculated by dividing the number of questions.
15815655|NCT04320459|Diagnostic Test|Bath Ankylosing Spondylitis Functional Index (BASFI)|It assess functional status. It was evaluated with a 10-question questionnaire. After taking the answer of each question out of 10, the total of the points was calculated by dividing the number of questions.
15815656|NCT04320459|Diagnostic Test|Ankylosing Spondylitis Quality of Life Questionnaire (ASQoL)|"It evaluates quality of life. Each statement on the ASQoL (18-item) is given a score of 1 or 0. A score of 1 is given where the item is affirmed, indicating adverse QoL. All item scores are summed to give a total score or index. Scores can range from 0 (good QoL) to 18 (poor QoL)."
15815657|NCT04320459|Diagnostic Test|Toronto Alexithymia Scale-20 (TAS-20)|It assess alexithymia. It is a 20 item questionnaire and each item is evaluated in a Likert type scale with five intervals (1= strongly disagree, 5=strongly agree). The total alexithymia score is the sum of responses to all 20 items, while the score for each subscale factor is the sum of the responses to that subscale. The TAS-20 uses cutoff scoring: equal to or less than 51 = non-alexithymia, equal to or greater than 61 = alexithymia. Scores of 52 to 60 = possible alexithymia.
15815696|NCT04320056|Other|Standard administration of oxygen flow|"The investigator recommended SpO2 target of 90-94%. The investigator will recommend that low/high SpO2 alarms be set at 88% and 96% if continuous oximetry is used.
~In this group the SpO2 was recorded any time with FreeO2 device - recording mode"
15815658|NCT04320459|Diagnostic Test|Beck's Depression Inventory (BDI)|It assess depression status. It is a 21-question multiple-choice self-report inventory, each set is ranked in terms of severity and scored from 0 to 3 with a total summed score range of 0-63. Higher scores indicate greater depressive severity. Conventional cutoffs are 0-9 for normal range, 10-18 for mild to moderate depression, 19-29 for moderate to severe depression, and 30-63 for severe depression.
15815659|NCT04320446|Behavioral|Test in the morning|The exercise test was performed between 8 a.m and 11 a.m
15815660|NCT04320446|Behavioral|Test in the afternoon|The exercise test was performed between 5 p.m. and 8 p.m.a
15815661|NCT04320433|Diagnostic Test|Oral glucose tolerance test|Participants will ingest 75g anhydrous glucose dissolved in a volume of 200mL of water (NUTER.TEC GLUCOS, Subra, Toulouse, France).
15815662|NCT04320420|Other|Adapted Physical Activity|"The APA program is defined in 3 stages:
~STEP 1: during the initial chemotherapy over 3 months
~3 supervised APA sessions/week on site:
~two muscle strengthening sessions, stretching, flexibility in the gym
~a cardio session (Nordic Walking: outdoors)
~at home: exercise book if the patient wishes
~STEP 2: during hospitalization for the autograft, over 1 month:
~2 sessions/week supervised by an APA engineer + exercise book and encouragement of individual work
~If the patient wishes, he can continue the exercises carried out with the APA engineer independently
~STEP 3: after the transplant
~the first 3 months:
~2 supervised indoor sessions/week (muscle strengthening, stretching, flexibility),
~1-hour cardio session/week independently
~the following 3 months: 1 indoor session per week + independent exercises at home and walking or cycling sessions"
15815664|NCT04320394|Diagnostic Test|QuantiFERON Monitor®|The test will be realised to evaluate sepsis induced immunosuppression on patient with septic shock
15815665|NCT04320381|Behavioral|Qualitative Interview|2 Semi-Structured Qualitative Interviews
15815666|NCT04320355|Other|Soft tissue manual therapy|The intervention is a type of massage.
15815670|NCT04320316|Drug|Crysvita (burosumab-twza) Treatment|KRN23 is a fully human IgG1monoclonal antibody that binds to and inhibits the activity of FGF23, leading to an increase in serum phosphorus levels. It is a potential therapeutic candidate for the treatment of XLH, Tumor-Induced Osteomalacia (TIO), and the rickets/osteomalacia resulting from Epidermal Nevus Syndrome (ENS). All of these conditions are diseases of bone hypomineralization, caused by urinary phosphate wasting due to elevated levels of FGF23.
15815671|NCT04320303|Biological|expanded NK cells|Donor derived expanded NK cells were infused to patients at around days 20±3d, and 27±3d post transplantation.
15815672|NCT04320290|Drug|Direct Acting Antivirals|8 weeks of DAA treatment
15815673|NCT04320277|Drug|Baricitinib|Baricitinib 4 mg/day/orally combined to antiviral therapy ritonavir for 2 weeks. Baricitinib tablets 4 mg were administered in the morning.
15815674|NCT04320264|Procedure|Weight loss surgery|Severely obese women (BMI >40) undergo sleeve gastrectomy
15815675|NCT04320251|Procedure|cochlear implant revision surgery|Observation during routine cochlear implant revision surgery
15815676|NCT04320238|Drug|recombinant human interferon Alpha-1b|recombinant human interferon Alpha-1b nasal drops, 2-3 drops for each nostril per time, 4 times per day.
15815677|NCT04320238|Drug|thymosin alpha 1|thymosin alpha 1 subcutaneous injection 1 time per week.
15815678|NCT04320225|Drug|Dexamethasone|HD-DXM (orally at 40 mg daily for 4d )
15815679|NCT04320212|Procedure|lumber epidural analgesia|the lumber epidural analgesia will be given after induction of general anesthesia.
15815680|NCT04320212|Procedure|erector spinae analgesia|the erector spinae analgesia will be given after induction of general anesthesia.
15815681|NCT04320199|Dietary Supplement|Fermented Protaetia brevitarsis seulensis powder group|This group takes Fermented Protaetia brevitarsis seulensis powder for 8 weeks
15815682|NCT04320199|Dietary Supplement|Placebo group|This group takes placebo for 8 weeks
15815683|NCT04320186|Behavioral|Entertainment education|
15815684|NCT04320186|Other|video|video
15815685|NCT04320173|Drug|Lidocaine patch 1.8%|Three patches are applied to the subject's back for 12 hours.
15815686|NCT04320173|Drug|Lidocaine patch 5%|Three patches are applied to the subject's back for 12 hours.
15815687|NCT04320173|Drug|Lidocaine medicated plaster 5%|Three plasters are applied to the subject's back for 12 hours.
15815688|NCT04320160|Procedure|Platelet rich plasma|"Eight milliliters of blood sample will be aspirated from the patient's peripheral vein, and the sample will be centrifuged at 1,500 rpm for 5 minutes.
~A 30-G needle will be used for superficial intradermal (ID) microinjections (0.1 mL per injection and space about 1 cm apart)"
15815689|NCT04320160|Procedure|Fractional CO2 laser|"Fifteen lesions will be treated by Fr: CO2 laser (10,600 nm; KES Corporation, Beijing, China).
~Scanner spot size will be adjusted based on the lesion size. Density selected will be 0.6 in the static mode.
~Two passes with minimal overlap will be delivered. The laser will be applied to the vitiligo lesion and over a thin rim of healthy skin"
15815690|NCT04320147|Device|Artemia|Before prostate biopsy, all patients be preceded by mpMRI.MR-targeted biopsy using Artemis device fusion of MRI and ultrasound images would be performed. MR targeted biopsy would be performed by radiologist.
15815691|NCT04320121|Dietary Supplement|Nelutri™|Nelutri™ 2,000 mg/day for 12 weeks
15815692|NCT04320121|Dietary Supplement|Placebo group|Placebo 2,000 mg/day for 12 weeks
15815693|NCT04320108|Device|Extracorporeal shockwave therapy|Extracorporeal shockwave therapy 6 times during 2 weeks
15815694|NCT04320095|Device|Bizact tonsillectomy device|Bizact tonsillectomy device is an advanced bipolar instrument that uses radiofrequency energy and pressure to ligate vessels interposed between its jaws. The energy produced by the device is automatically adjusted based on tissue impedance in an attempt to minimize thermal tissue damage.
15817141|NCT04308434|Other|CSD190601-21|Flavor variant CSD190601-21 of a 3.0% nicotine ENDS product
15815697|NCT04320056|Device|Automated oxygen administration - FreeO2|In this group, oxygen administration will be delivered with FreeO2 (automated oxygen titration) with SpO2 target set at 92% (to maintain oxygenation in the recommended SpO2 target: 90-94%)
15815698|NCT04320043|Procedure|Anterior cervical decompression|Any of the following anterior surgical techniques used to decompress the cervical nerve roots or spinal cord; corpectomy, Anterior Cervical Discectomy (ACD), Anterior Cervical Decompression and Fusion (ACDF) or ACDF with Plating
15815700|NCT04320017|Diagnostic Test|Electrocardiogram, transthoracic echocardiography and clinico-biological parameters in routine care|"12 derivations electrocardiogram done at baseline and repeated every 3 days
~transthoracic echocardiography at baseline
~clinical features at baseline: WHO performans status comorbidities and treatments
~biological results in routine care, such as baseline full blood count, inflammation markers: C-reactive protein, procalcitonin, interleukin-6 and ferritin, coagulation and troponin and brain natriuretic peptide"
15815701|NCT04320004|Behavioral|Education|Subject receives education
15815702|NCT04320004|Behavioral|Education with Reminder|Subject receives education with reminder
15815703|NCT04320004|Behavioral|Education + Disposal Bag|Subject receives education and disposal bag
15815704|NCT04320004|Behavioral|Education + Disposal Bag with Reminder|Subject receives education + disposal bag with reminder
15815705|NCT04319991|Dietary Supplement|Probiotics product|This Probiotics product is a supplement containing several types of probiotics and prebiotics which has been marketed for years in Taiwan. Each sachet contains 3 grams granule. Take 1 sticks 3 times per day with or without water before meals.
15815706|NCT04319978|Drug|Dexamethasone injection|Dexamethasone is a synthetic corticosteroid. Dexamethasone is an adequate measure for reducing pain and edema in the post-operative recuperation period following 3rd molar surgery. A single dose of IM 8mg dexamethasone will be used for each patient.
15815707|NCT04319952|Device|Primary Total Hip Replacement with Metafix™ femoral stem and Trinity™ acetabular cup or TriFit-CF™/TriFit-TS™ femoral stem and Trinity™ acetabular cup implanted by a single surgeon.|The participant will undergo surgery using the hip prostheses and direct anterior surgical approach used by their surgeon-investigator. A patient-specific femoral guide, generated by the OPS™ Plan preoperatively, will be used during the surgical step of the femoral neck resection. These are not study specific procedures as the OPS™ Plan is already in use by the surgeon-investigator in their standard of care practice.
15815708|NCT04319939|Other|Assist Control Mode and Pressure Support Mode Mechanical Ventilation|Diaphragm ultrasound measurements (end expiration and peak inspiration thickness) will be performed in assist control mode and pressure support mode mechanical ventilation in each participant. The participant will thus serve as his/her own control for these interventions.
15815709|NCT04319926|Drug|lidocaine topical system 1.8%|One topical system is applied to the subject's back for 12 hours.
15815710|NCT04319926|Drug|lidocaine patch 5%|One generic lidocaine patch is applied to the subject's back for 12 hours.
15815711|NCT04319913|Device|analgesia nociception index|Analgesia nociception index (ANI) could objectively monitor how pain the participant is. In the experimental group, the care provider would decrease the dose of narcotics (remifentanil) if the ANI value is above 70, and increase the dose if the ANI value is under 50.
15815712|NCT04319900|Drug|favipiravir tablets+chloroquine phosphatetablets tablets|"Favipiravir tablets+ chloroquine phosphate tablets group: 50 patients (anticipated).
~Favipiravir tablets: On the first day, once for 1600 mg, twice a day; From the 2nd day to the 10th day, once for 600 mg, twice a day; maximum of 10 days for oral administration of the drug.
~Chloroquine phosphate tablets: a total of 1000mg split into two times on day one; from day two to day three, 500mg, once a day; from day four to day ten, 250mg, once a day. Maximum of 10 days for oral administration of the drug."
15815713|NCT04319900|Drug|Favipiravir tablets|Favipiravir tablets group: 50 patients (anticipated). Favipiravir tablets: On the first day, once for 1600 mg, twice a day; From the 2nd day to the 10th day, once for 600 mg, twice a day; maximum of 10 days for oral administration of the drug.
15815714|NCT04319900|Drug|Placebo|Placebo for favipiravir tablets is produced by Zhejiang Haizheng pharmaceutical co, LTD, batch no. 21812252, Placebo for chloroquine phosphate tablets is produced by the Chinese people's liberation army academy of military science military medical research institute production, batch no. 20200215. All placebos were complied with the quality inspection standard.
15815715|NCT04319874|Drug|Ganoderma lucidum|Participants take ganoderma lucidum spore powder once a day, 1000mg
15815716|NCT04319874|Drug|Chemotherapy|Subjects are treated with conventional chemotherapy
15815717|NCT04319874|Drug|Placebos|Subjects are treated with conventional chemotherapy and Placebos once a day, 1000mg
15815718|NCT04319861|Procedure|Anal fistula plug procedure|A fistula probe was used to identify fistula tracts, and internal and external openings. Gentle mechanical debridement was performed with a blunt curette to remove the necrotic tissue with care not to enlarge the track, then hydrogen peroxide and sterile saline were used to repeatedly to irrigate the fistula. The anal fistutla plug was filled into the fistula, and sutured with a figure-of-eight 2-to-0 Vicryl suture to ensure the plug was fixed in the internal opening of the fistula, avoiding the anal fistula plug being extruded. Trimming the plug at the external fistula and the external opening was left open to ensure adequate drainage.
15815719|NCT04319848|Other|TE-EK treatment group|Transplantation of tissue-engineered endothelial graft through DSAEK procedure.
15815720|NCT04319835|Device|OnZurf Probe|
15815721|NCT04319822|Other|blood sample and muscular biopsy|blood sample and muscular biopsy
15815722|NCT04319809|Device|Object recognition subsystem|The object recognition subsystem is an add-on to the Argus II retinal prosthesis system. in the early stage of the study the subsystem will run on a separate processor; in the later stage the subsystem will run in the Argus II user's video processing unit.
15815755|NCT04319549|Other|Ketorolac Tromethamine irrigant|Ketorolac tromethamine, a potent NSAID available in both oral and injectable forms, is over 400 times more potent as a selective inhibitor of COX-1 over COX-2 than many other drugs. When ketorolac tromethamine was used as an intracanal medicament in teeth with irreversible pulpitis undergoing root canal treatment, it contributed to significant post operative pain relief.
15815790|NCT04319302|Procedure|Isolated Vascularized Gastric Tube (IVGT) graft|A conduit was created by tubularising a vascularized segment of the greater curve of the antrum of the stomach and this was used between the remaining common hepatic duct and the duodenum.
15815723|NCT04319796|Other|Data set as defined by the ERN Research Workgroup of the European Commission|"The ERN-RND registry will be restricted to the minimum data set as defined by the ERN Research Workgroup of the European Commission. This includes the following data:
~Name of specialist center
~Pseudonym:
~Date of birth: For confidentiality reasons the ERN-RND registry will restrict this information to the Year of birth
~Sex
~Date of death: For confidentiality reasons the ERN-RND registry will restrict this information to the Year of death
~Age of onset
~Orphacode for specific rare disease: https://www.orpha.net/consor/cgi-bin/Disease_Search.php?lng=DE
~Online Mendelian Inheritance in Man (OMIM) code as defined for genetic diseases: https://www.omim.org/
~Human Phenotype Ontology (HPO) terms for key features: https://hpo.jax.org/app/
~Agreement to be contacted for research purposes: Yes/No
~Biological samples (Yes / No)
~Link to a biobank (Link / No)
~Classification of disability (Disease group specific score)"
15815724|NCT04319783|Drug|Darolutamide|Darolutamide alone
15815725|NCT04319783|Radiation|Radiotherapy|Darolutamide + Consolidation Radiotherapy
15815726|NCT04319770|Device|enamel matrix derivative (EMD)|periodontal regenerative surgery with enamel matrix derivative (EMD) (control)
15815727|NCT04319770|Device|hyaluronic acid (HA)|periodontal regenerative surgery with hyaluronic acid (HA) (test)
15815728|NCT04319757|Drug|ACE1702|ACE1702 cellular therapy (anti-HER2 oNK cells) given intravenously
15815729|NCT04319757|Drug|Cyclophosphamide|Lympho-conditioning agent
15815730|NCT04319757|Drug|Fludarabine|Lympho-conditioning agent
15815731|NCT04319744|Other|other|Our hypothesis is that playing video games may have positive effects on videostile use, but there is no research on this subject Our goal is to compare the performances of anesthesia assistants who have played video games with those who did not.
15815732|NCT04319731|Biological|Human Amniotic Fluid|Administration of amniotic fluid in SARS-CoV-2 positive patients
15815735|NCT04319705|Drug|Azithromycin|Azithromycin, 500mg, 3 times per week, 12-week treatment period, administered orally
15815736|NCT04319705|Drug|Placebo oral tablet|capsule containing placebo, 3 times per week, 12-week treatment period, administered orally
15815737|NCT04319692|Dietary Supplement|Fermented Prunus Mume Vinegar group|This group takes Fermented Prunus Mume Vinegar for 8 weeks
15815738|NCT04319692|Dietary Supplement|Placebo group|This group takes placebo for 8 weeks.
15815739|NCT04319679|Device|Extracorporeal shockwave therapy|6 times during 2 weeks
15815740|NCT04319679|Device|Sham therapy|6 times during 2 weeks
15815741|NCT04319666|Device|Left main stenting with intravascular lithotripsy|Intravascular lithotripsy (IVL) will be used to modify coronary artery calcification prior to stent implantation in left main coronary disease. Intravascular ultrasound (IVUS) will be used pre and post IVL and post stenting.
15815742|NCT04319653|Device|Dynamic pelvic MRI with intravaginal probe with pressure sensor|Dynamic pelvic MRI with intravaginal probe and intravaginal and intrarectal opacification gel
15815743|NCT04319640|Behavioral|Cognitive behaviour therapy for insomnia|CBT-I for children with ASD includes sleep hygiene, restriction of time in bed, stimulus control, cognitive therapy, and relaxation techniques. The treatment consists of 5 weekly modules.
15815744|NCT04319640|Behavioral|psychoeducation for ASD|psychoeducation contains information about ASD, The treatment consists of 5 weekly modules.
15815745|NCT04319627|Drug|Rosuvastatin Calcium|Each participant will receive the usual treatment for their newly diagnosed blood clot in addition to the intervention they are randomized to.
15815746|NCT04319627|Drug|Placebo Oral Tablet|Each participant will receive the usual treatment for their newly diagnosed blood clot in addition to the intervention they are randomized to.
15815747|NCT04319614|Drug|Tranexamic Acid Injectable Product|A single dose of tranexamic acid, corresponding to 20 mg/kg in 100 ml saline, will be administered in the beginning of procedure.
15815748|NCT04319614|Drug|Placebos|100 ml of saline will be administered in the beginning of the procedure.
15815749|NCT04319601|Drug|Rituximab|a new chemotherapy regimen
15815750|NCT04319588|Procedure|Parasternal Block+ Infiltration with local anesthetic of access to thoracic drainage|After induction of general anesthesia we will perform an ultrasound-guided Parasternal Block in association with infiltration with local anesthetic of access to thoracic drainage at the end of the intervention.
15815751|NCT04319588|Procedure|Infiltration with local anesthetic of access to thoracic drainage|Infiltration with local anesthetic of access to thoracic drainage at the end of the intervention.
15815752|NCT04319575|Drug|root canal treatment and intracanal medicament|"after the access preparation and cleaning and shaping was done in 1st appointment using k files,Mani and protapers,Dentsply then in, chitosan calcium hydroxide paste, or ciprofloxacin metronidazole minocycline paste placed in the canal and kept for 4 weeks."
15815753|NCT04319562|Procedure|needle-embedding therapy|"First group is comprised of Xinshu (BL15), Ganshu (BL18), Juque (CV14) bilaterally, and Xin and Gan of auricular point on the left ear. Second group includes Shentang (BL44), Hunmen (BL47), Jiuwei (RN15) bilaterally, and Xin and Gan of auricular point on the right side.
~After skin cleansing with a 75% alcohol swab, intradermal thumbtack needle will be quickly inserted into the skin and embedded at acupoints mentioned above bilaterally. The needles will remain in the acupoints for 3 days and they will be removed by the therapists at next visit. This also can ensure better implementation of the blind method.Participants are required to receive this treatment twice a week. The specification of the needle used in the back shu point is φ9mm 0.20×1.5mm (Seirin® PYONEX; Seirin Corporation, Shizuoka, Japan), that in the auricular point is φ9mm 0.20×0.6mm (Seirin® PYONEX; Seirin Corporation, Shizuoka, Japan)."
15815754|NCT04319562|Device|shame needle-embedding therapy|The acupoint selection in this group is the same as in the needle-embedding therapy group, except that the shame intradermal needles will be used. After skin cleansing with a 75% alcohol swab, the shame intradermal needles，instead of insert into the skin, it can only stick on the surface of the skin. It also will be removed by the therapists after 3 days. This takes place twice a week. The specification of the shame needle is the same as above.
15815788|NCT04319328|Drug|Ciprofloxacin|Non-interventional pharmacokinetic evaluation
15815789|NCT04319315|Other|survey|online survey
15815756|NCT04319549|Other|sodium hypochlorite irrigant|NaOCl is the gold standard and the most commonly used root canal irrigant. NaOCl is able to dissolve the organic tissues inside root canal due to its alkalinity (pH11), which causes amino acid degradation and hydrolysis through the production of chloramine molecules. In addition, it possesses highly antibacterial effect and its low cost makes it the most frequently used root canal irrigant. Dual rinse is considered an effective time saving root canal irrigant with a better antibacterial property in comparison to NaOCl alone. In addition to its effectiveness on smear layer removal and reduction in the debris accumulation during root canal instrumentation.
15815757|NCT04319536|Other|no intervention|self-sampling
15815758|NCT04319510|Procedure|Craniosacral therapy|The first experimental group of patients will receive 24 units à 45 minutes over 12 weeks (2 consecutive units per week) offered by a trained craniosacral therapist within a 1:1 setting. Treatment as usual is allowed.
15815759|NCT04319510|Procedure|Craniosacral self-help group training|The second experimental group of patients will receive 24 teaching units (TUs) à 45 minutes over 12 weeks offered by a trained craniosacral therapist within a group setting. The group training will start with an introductory day (8 TUs), followed by 6 practice evenings every two weeks (2 TUs each) and a final afternoon (4 TUs). The patients have to agree to participate with a partner (husband, child, friend, etc.) in the introductory day and 90% of the following TUs. All patients will receive a script with theoretical CST information and descriptions of the learned techniques, which should facilitate the correct practice at home. Treatment as usual is allowed.
15815760|NCT04319510|Procedure|Treatment as usal / wait list|The control group will receive no specific study treatment for a waiting period of six months. Treatment as usual is allowed. Afterwards they were offered 2 treatments (4TUS) of 1:1 CST and the participation in the group training.
15815761|NCT04319497|Device|Subjective refraction|Subjective refraction measurements will be performed by two testers for all the patients included
15815762|NCT04319497|Device|Autorefraction|Five autorefraction measurements will be performed for all the patients included
15815763|NCT04319497|Device|Wavefront aberrometry|Five wavefront measurements will be performed for all the patients included
15815764|NCT04319484|Drug|lenvatinib|1-2 months after liver transplantation, participants are given lenvatinib with an initial dose of 8 mg (body weight < 60 kg) or 12 mg orally once a day. The initial dose was 8 mg (body weight < 60 kg) or 12 mg orally once a day.
15815765|NCT04319484|Drug|Placebo|1-2 months after liver transplantation, participants are given Placebo with an initial dose of 8 mg (body weight < 60 kg) or 12 mg orally once a day. The initial dose was 8 mg (body weight < 60 kg) or 12 mg orally once a day.
15815766|NCT04319471|Drug|Capecitabine/S-1|Drug: Capecitabine/S-1
15815767|NCT04319471|Drug|Chemotherapy|Gemcitabine (1000mg/m2) D1 D8+ nidaplatinum (80-100mg/m2) D2 q3w ×4-6cycle
15815768|NCT04319471|Radiation|Head and neck radiotherapy|IMRT is uesd for the synchronous oligometastatic Nasopharyngeal Carcinoma；
15815769|NCT04319471|Other|Local Consolidative Therapy|radiotherapy，surgery or interventional therapy for all metastatic sites.
15815770|NCT04319458|Behavioral|Fotonovela|Secret Feelings/Sentimientos Secretos
15815771|NCT04319458|Behavioral|Control|NIH Brochure: Depression: What You Need to Know
15815772|NCT04319445|Behavioral|Mindfulness session(s)|The sessions will be hosted online using an online platform (such as through webex, private YouTube page, Facebook live, etc).
15815773|NCT04319432|Behavioral|Voice rest|The first days will take place in hospitalization to assess patient complience to voice rest. Patients will be instructed to continue voice rest at home up to 7 days accourding to group allocation in the study. The confirmation of voice rest will relay on patient report (telephonic approval), after the voice rest period will end.
15815774|NCT04319419|Dietary Supplement|Supplement with micronutrients|Obese children were divided in 2 groups. A group received the supplement plus nutrition education and other group was a control, only received nutrition education.
15815775|NCT04319419|Other|Nutrition education|Group received nutrition education program during 6 months
15815776|NCT04319406|Procedure|Prolotherapy|Test group will be administered 12.5% Dextrose mainly into superior joint space according to symptoms of patient at baseline (0 week) and at biweekly intervals at 2 and 4 weeks i.e. a total of 3 injections. A 4th injection will be given at 6 weeks if required.
15815777|NCT04319406|Procedure|Dry needling|Only dry needling will be performed at baseline (0 week) and at biweekly intervals at 2 and 4 weeks i.e. a total of 3 injections. A 4th injection will be given at 6 weeks if required.
15815778|NCT04319393|Behavioral|Cognitive Behavioral Therapy|"The CBT intervention was carried out through six two-hour sessions over a month. The intervention group was divided into three subgroups of 18 to 19 nurses each. It was required for each subgroup to attend two CBT sessions to complete the intervention.
~The CB therapist followed the same structure in the delivery of each CBT session. The CBT session was delivered in five modules: generating objectives and outcomes, enhancing self-esteem and interpersonal relationships, changing beliefs regarding symbolic mortality, and changing attitudes regarding death anxiety. The first session began with highlighting the objectives of the CBT. Then, a detailed presentation of the intervention modules was provided to the nurses with integration of CBT exercises, including cognitive restructuring, graded exposure, mindfulness meditation, interpersonal skills training, and activity scheduling"
15815779|NCT04319380|Biological|Tetanus/diphtheria toxoids|One dose of tetanus/diphtheria toxoids vaccine (June) in year 1 and year 2.
15815780|NCT04319380|Drug|SMC with SP+AQ|Year 1 and 2 (2020/21) Four cycles of SMC (SP+AQ) (July, August, September, October). One cycle of SMC consisting of sulphadoxine - pyrimethamine (SP) 500mg/25 mg, and amodiaquine (AQ) 150mg on day 1, and AQ 150mg on days 2 and 3.
15815781|NCT04319380|Biological|RTS,S/AS01|One booster dose of RTSS/AS01 (June) in year 1 and 2.
15815782|NCT04319380|Drug|SMC placebo|Year 1 and 2 (2020/21) Four cycles of SMC placebo (July, August, September, October)
15815783|NCT04319367|Drug|Investigational Medicinal Product|Recombinant human monoclonal antibody (mAb) or placebo
15815784|NCT04319354|Diagnostic Test|Analysis of cfDNA|Analysis of cfDNA through liquid biopsy
15815785|NCT04319341|Other|To study the prognostic value on the occurrence of pre-eclampsia, ADAMTS13 (ADAMTS13 protein and autoantibodies) in patients diagnosed with oAPS|ADAMTS13 activity, ADAMS13 antigen and anti-ADAMTS13 autoantibodies: U/ml.
15815786|NCT04319328|Drug|Cefazolin|Non-interventional pharmacokinetic evaluation
15815787|NCT04319328|Drug|Ceftazidime|Non-interventional pharmacokinetic evaluation
15815791|NCT04319289|Other|aerobic interval training and Vitamin D supplementation,|"The participants in both groups A will be instructed to perform aerobic interval exercises at 70% maxHR for 5 minutes and then decrease activity to 50% for 5 minutes and repeat for the length of the activity (the training will be done by using bicycle ergometer(Biodex LBC, Biodex Inc., New York).• Before starting training ; Maximum heart rate calculated from the following equation: maxHR= 220-age .
~Duration: the first five to ten minutes of each session were dedicated to warming up exercise on the bicycle in the form of slow progression exercise (to decrease the risk of hypotension, musculoskeletal injury and cardiovascular complications), followed by the active phase of exercise for 40 min., and finally cooling down phase for ten minutes. with intensity and speed decreased gradually until reaching the resting HR
~Frequency: 3 days/week., for 12 weeks
~Also all participants in this group are taking gne capsule containing (cholecalciferol 400 IU) every day ."
15815792|NCT04319289|Drug|Vitamin D supplementation only|One capsule containing (cholecalciferol 400 IU) was taken every day .
15815793|NCT04319289|Other|aerobic interval training only|"The participants in group C will be instructed to perform aerobic interval exercises at 70% maxHR for 5 minutes and then decrease activity to 50% for 5 minutes and repeat for the length of the activity (the training will be done by using bicycle ergometer(Biodex LBC, Biodex Inc., New York).• Before starting training ; Maximum heart rate calculated from the following equation: maxHR= 220-age (Gellish ,2007).
~Duration: the first five to ten minutes of each session were dedicated to warming up exercise on the bicycle in the form of slow progression exercise (to decrease the risk of hypotension, musculoskeletal injury and cardiovascular complications), followed by the active phase of exercise for 40 min., and finally cooling down phase for ten minutes. with intensity and speed decreased gradually until reaching the resting heart rate (Broderick et al.,2014).
~Frequency: 3 days/week. The whole training lasting for 12 weeks"
15815798|NCT04319263|Drug|induction regimen of intravesical BCG|intravesical instillation of 6 weekly doses of BCG
15815799|NCT04319250|Other|ischemic compression|ATNs detected in a total of 13 muscles around the shoulder were applied constant pressure at the level of pain tolerated with the thumb (discomfort severity level 7 to 8 out of 10) and for 90 seconds. This method was applied twice a week for 6 weeks.
15815800|NCT04319250|Other|IASTM|"In order to apply EDYDM in the treatment of ATN, titanium plated stainless steel was divided into two parts, front and back, with two tools. The sweep was applied to the anterior muscle fibers at an angle of 45 ° for 40 seconds.
~For each TN, continuous pressure was applied with swivel movement at tolerable pain level (discomfort severity level 7 to 8 out of 10) for 1 minute. The back group muscles were applied in the same way."
15815801|NCT04319250|Other|Rehabilitation Program|A rehabilitation program consisting of exercises and manual therapy used in the conservative treatment of rotator cuff tear for both groups was applied twice a week for 6 weeks.
15815802|NCT04319237|Other|Handgrip strength test|The purpose of this test is to measure the maximum isometric strength of the hand and forearm muscles.
15815803|NCT04319237|Behavioral|Neuropsychological Assessment - Wechsler Test of Adult Reading (WTAR)|"The Wechsler Test of Adult Reading (WTAR) is a neuropsychological assessment tool used to provide a measure of Intellectual function. Participants are presented with 50 irregularly spelled words and prompted to pronounce each; the irregular grapheme-to-phoneme translations (such as the gh in the word tough) in the prompts make it difficult to pronounce without having previously learned the word. A high WTAR score is correlated with higher general intelligence as measured by the Wechsler intelligence scales."
15815804|NCT04319237|Behavioral|Neuropsychological Assessment - Repeatable Battery for the Assessment of Status (RBANS)|The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) consists of twelve subtests which give five scores, one for each of the five domains tested (immediate memory, visuospatial/constructional, language, attention, delayed memory).
15815805|NCT04319237|Behavioral|Neuropsychological Assessment - Color Trails|The Color Trails test measures sustained attention and sequencing. Numbered circles are printed with vivid pink or yellow backgrounds that are perceptible to color-blind individuals. Participants rapidly connect circles numbered 1-25 in sequence and rapidly connect numbered circles in sequence, but alternates between pink and yellow. The length of time to complete each trial is recorded, along with qualitative features of performance indicative of brain dysfunction, such as near-misses, prompts, number sequence errors, and color sequence errors.
15815806|NCT04319237|Behavioral|Neuropsychological Assessment -Stroop Color and Word Test|The Stroop Color and Word Test is based on the observation that individuals can read words much faster than they can identify and name colors. The test-taker reads color words or names ink colors from different pages as quickly as possible within a time limit. The test yields three scores based on the number of items completed on each of the three stimulus sheets. An Interference score is useful in determining the individual's cognitive flexibility, creativity, and reaction to cognitive pressures.
15815807|NCT04319237|Behavioral|Patient Reported Outcomes Measurement Information System-29 (PROMIS-29) Questionnaire|The PROMIS-29 questionnaire assesses each of 7 domains (Depression, Anxiety, Physical Function, Pain Interference, Fatigue, Sleep Disturbance, and Ability to Participate in Social Roles and Activities). A higher score equals more of the concept being measured.
15815808|NCT04319237|Behavioral|European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire|European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C-3) and the add-on EORTC QLQ Non-Hodgkin's Lymphoma (EORTC QLQ-NHL-HG29) module. All scales range from 0-100, a high scale score represents a higher response level. For example, a high functional score represents a high level of functioning.
15815897|NCT04318392|Other|Bronchoalveolar lavage|Bronchoalveolar lavage will be performed at baseline on all participants undergoing investigation with bronchoscopy or EBUS as part of routine clinical care for investigation of suspected sarcoidosis.
15815809|NCT04319237|Behavioral|Quality of Life (EQ-5D-5L) Questionnaire|The EQ-5D-5L questionnaire is a self assessed quality of life questionnaire. The scale measures quality of life on a 5 component scale including mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The rater selects a number between 1-100 to describe the condition of their health, 100 being the best imaginable.
15815810|NCT04319237|Behavioral|PROMIS Cognitive Function 4a Questionnaire|The PROMIS measures function, symptoms, behavior and feelings.
15815811|NCT04319237|Behavioral|Comprehensive Score for Financial Toxicity (COST) measure|The COST is a questionnaire made up of 11 statements around topics including costs, concerns and resources and is designed to measure financial toxicity. The user answers questions about their concern over finances numbered from 0-4, with 0 being not at all and 4 being very much.
15815812|NCT04319224|Drug|Vopratelimab|Specified dose on specified days
15815813|NCT04319224|Drug|Ipilimumab|Specified dose on specified days
15815814|NCT04319224|Drug|Nivolumab|Specified dose on specified days
15815815|NCT04319211|Other|Determination of physical activity, quality of life, stress levels of isolated people at home with the danger of coronavirus.|The study will include those who isolate themselves at home for fear of contracting Coronavirus disease or suspected of having it. The last three sections of the International Physical Activity Questionnaire (IPAQ) will be used to evaluate the current physical activity level of the participants. Parameters such as housework, home care and family care, rest, sports and leisure physical activities, sitting time will be evaluated. Short Form 12 (Short Form12- SF12) quality of life scale will be used to evaluate health-related quality of life. Beck Depression Scale will be applied to investigate the stress levels of the individuals participating in our study.
15815817|NCT04319185|Other|Assistance to perform Peritoneal Dialysis (PD) at home|The patient receives assistance of up to one visit per day for three months depending on the patient's needs, as assessed by the interdisciplinary team, the nephrologist, and the primary investigator or delegate.
15815818|NCT04319159|Combination Product|BF-200 ALA and red light LED lamp|Combination Product: Photodynamic therapy (PDT) using BF-RhodoLED® (ALA-PDT, Ameluz®-PDT).
15815819|NCT04319146|Procedure|robot-assisted radical prostatectomy|robot-assisted radical prostatectomy as first-line treatment
15815820|NCT04319133|Behavioral|Fasting|Doing fasting 2 days a week within 8 weeks
15815821|NCT04319120|Other|questionnaires online|Each month, the nurse will contact the patients included, by mail or telephone, to fill out their questionnaires online or by mail, and to make a photo of the ulcer if it is healed. A dedicated telephone line and e-mail address will be used as a support if necessary (for questionnaires, emails or sending photos). The referring nurse and the clinical research assistant of the service will be in charge of centralizing the data collected.
15815822|NCT04319107|Other|ophthalmological examinations using a slit lamp bio microscopy and a three-mirror lens, standard procedure.|Pupillary dilatation was performed with instillation of tropicamide and phenylephrine. The ophthalmological examination included visual acuity measurement, using a slit lamp biomicroscopy to analyse the anterior segment and a three mirror lens to appreciate the quality of the dilation validated by the absence of pupillary reflex and to search for ectopia lentis. Ectopia Lentis grade is evaluated according to the 5-grade classification.
15815823|NCT04319094|Behavioral|PEERS|Peer mentors deliver depression care that include social support and coping skills, focused on goal setting and small behavioral changes.
15815824|NCT04319094|Other|Social interaction|Study staff will provide a combination of 8 social interaction visits and phone calls to the participants randomized to this condition.
15815825|NCT04319081|Drug|PCSK9 inhibitor|Patients are included after PCSK9 inhibitors prescription , at the first dispensation
15815826|NCT04319042|Procedure|Immediate Loading|The implant receives an artificial tooth the same day as it is placed.
15815827|NCT04319042|Procedure|Early Loading|The implant receives an artificial tooth 4 weeks after placement.
15815828|NCT04319029|Behavioral|Pharmaceutical care plan|"The design of the intervention was based on a stepwise approach to address the following point in each participant: set priorities for patient care, assessment of patient's educational needs, and development of a comprehensive and achievable pharmaceutical care plan.
~The participants will be educated about their illness and informed about the proper use of their medication in a structured manner (it involved the following items: dyslipidemia as a disease, complications, who therapy reduces its risk and complications, goal of therapy). Behavioral modifications will involve the following: physical exercise, diet, smoking cessation. Patients will obtain this information verbally and provided in a written manner through a brochure that design for this study."
15815829|NCT04319016|Other|pregnant women with laboratory-confirmed 2019-n-CoV|Clinical records and compiled data of all consecutive hospitalized and outpatient pregnant women with laboratory-confirmed 2019-n-CoV were included in a merged database
15815830|NCT04319003|Behavioral|Sugar-reduction intervention|The intervention consisted of a) installation of a water filter at the school. b) each participant received a metal water bottle. c) a registered dietitian gave a 30-minute presentation on sugar reduction for the purposes of type 2 diabetes prevention
15815831|NCT04318990|Procedure|Distal radial artery access|Patients undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized 1:1 to distal or proximal radial access for cardiac catheterization.
15815832|NCT04318990|Procedure|Proximal radial artery surgery|Patients undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized 1:1 to distal or proximal radial access for cardiac catheterization.
15815833|NCT04318977|Device|high-frequency rTMS|repetitive transcranial magnetic stimulation
15815834|NCT04318977|Device|TBS|theta burst stimulation
15815835|NCT04318977|Device|placebo|placebo transcranial magnetic stimulation
15815863|NCT04318678|Drug|Fludarabine|Fludarabine phosphate is a synthetic purine nucleoside analog. It acts by inhibiting DNA polymerase, ribonucleotide reductase and DNA primase by competing with the physiologic substrate, deoxyadenosine triphosphate, resulting in inhibition of DNA synthesis
15815864|NCT04318678|Drug|Mesna|Mesna is a synthetic sulfhydryl (thiol) compound. Mesna contains free sulfhydryl groups that interact chemically with urotoxic metabolites of oxaza-phosphorine derivatives such as cyclophosphamide and ifosfamide
15815865|NCT04318678|Drug|Rituximab|Rituximab is a monoclonal antibody directed against the CD20 antigen on the surface of B-lymphocytes
15815836|NCT04318964|Biological|TAEST16001 cells|"The patients in the dose increasing part and the expanding part received the intravenous reinfusion of TAEST16001 cells on the 5th day (i.e. the interval was 4 days) after the lymphocyte elimination chemotherapy: If the dose level of reinfusion was 1 and 2, the planned total amount of TAEST16001cells (calculated by TCR-T positive cells) was given a single reinfusion on the 1st day of the study. If the dose level of reinfusion was 3 and 4,then the total amount of TAEST16001cells (calculated by TCR-T positive cells) was planned to be reinjected in 60% and 40% proportion on the first and second day of the study.
~After the first reinfusion of TAEST16001 cells, the patients will be given a small dose of IL-2 subcutaneously (study day 1 to day 14), 500000 U / time. The first injection will be carried out within 30 minutes after the cell reinfusion, twice a day (interval 10-12 hours), for 14 days."
15815837|NCT04318951|Behavioral|Intensive communicative-pragmatic social interaction.|"ILAT requires individuals with aphasia to engage in social interaction. Groups of three patients and a therapist are seated around a table and provided with picture cards showing different objects (e.g., bottle). Each card has a duplicate that is owned by one of the other players. The goal is to obtain this duplicate from a fellow player by requesting the depicted object (e.g., Give me the […]). If the duplicate is available, the addressee hands over the corresponding card to the person who initiated the request sequence. If the duplicate is not available, the addressee rejects the request. In the event of misunderstandings, the players ask clarifying questions. Throughout the training, participants use formulaic expressions to indicate whether a request is accepted (Here you are, Thank you, You're welcome), rejected (I'm sorry, No problem, Too bad) or unclear (Pardon me?). Treatment duration will be four weeks."
15815838|NCT04318951|Behavioral|Standard care.|Depending on the participants' diagnoses and needs, standard care will include: occupational therapy (2-3 hours of weekly practice), physiotherapy (3 hours of weekly practice), and speech-language therapy (2-3 hours of weekly practice with non-communicative, impairment-specific exercises). Standard care will be delivered in accordance with state-of-the-art procedures in rehabilitation centers certified in Germany. Treatment duration will be four weeks.
15815839|NCT04318938|Drug|Brigatinib|Treatment with Brigatinib
15815840|NCT04318938|Drug|Tyrosine kinase inhibitor|Treatment with any TKI
15815841|NCT04318899|Behavioral|Dialectical Behaviour Therapy adapted for adolescents (DBT-A)|DBT developed by Marsha Linehan (Linehan 1993a; 1993b) and adapted for adolescents (DBT-A) by Miller, Rathus & Linehan, 2007 consisting of 20 weeks of weekly individual therapy (60 minutes), multifamily skills training (120 minutes), family therapy sessions as needed and telephone coaching outside therapy sessions.
15815842|NCT04318899|Behavioral|Dialectical Behaviour Therapy - Standard version (DBT)|DBT developed by Marsha Linehan (Linehan 1993a, 1993 b) consisting of 1 weekly session of individual therapy (60 minutes), 1 weekly session of skills training (120 minutes), and telephone coaching with individual therapists outside therapy sessions as needed.
15815843|NCT04318886|Behavioral|ENABLE Cornerstone|The ENABLE (Educate, Nurture, Advise, Before Life Ends) Cornerstone intervention is led by a specially-trained lay coach who is overseen by an interdisciplinary outpatient palliative care team, who employs health coaching techniques and caregiver distress assessment to behaviorally activate and reinforce psychoeducation on managing stress and coping, getting and asking for help, improving caregiving skills, and decision-making/advance care planning over 6 brief in-person/telephonic sessions plus monthly follow-up from diagnosis through early bereavement.
15815844|NCT04318873|Other|Packed Promise Demonstration Benefits|Monthly: Home-delivered food box, nutrition education handout, and $15 monthly voucher for fruits and vegetables
15815845|NCT04318847|Drug|Ondansetron 4 MG|Administration of ondansetron 4 mg or 8 mg according to weight
15815846|NCT04318834|Other|Tumour and germline molecular profiling|Tumour whole genome sequencing, germline whole genome sequencing, tumour whole transcriptome sequencing
15815847|NCT04318821|Procedure|Laser acupuncture|Laser acupuncture is a non-invasive therapy that involves stimulation of traditional acupoints with low-intensity, non-thermal laser irradiation.
15815848|NCT04318808|Procedure|Laser acupuncture|Laser acupuncture is a non-invasive therapy that involves stimulation of traditional acupoints with low-intensity, non-thermal laser irradiation.
15815849|NCT04318795|Procedure|minimally invasive spinal decompression (MIS-D)|lumbar spinal decompression alone using minimally invasive approach, without any fusion or implantation
15815850|NCT04318795|Procedure|minimally invasive spinal decompression and fusion (MIS-TLIF)|lumbar spinal decompression plus interbody fusion with implantation using minimally invasive approach
15815851|NCT04318782|Device|Pharmacodynamic thrombectomy|Pharmacodynamic thrombectomy using AngioJet ™ PE Thrombectomy Catheter
15815852|NCT04318769|Behavioral|AFFIRM|AFFIRM is an 8-session manualized group coping skills intervention focused on reducing sexual risk behaviours and psychosocial distress among SGMY. AFFIRM is delivered by two facilitators (primarily social workers and peers) through a combination of education and rehearsal (i.e., simulation of real-life experiences) in a manner that affirms participants' sexual and gender minority identities and experiences.
15815853|NCT04318756|Behavioral|Translation and cultural adaptation go the cancer worry scale|To develop and validate the Italian version of Cancer worry scale using high risk subjects for familiarity/genetic predisposition and patients with premalignant lesions.
15815854|NCT04318743|Drug|Glepaglutide|GLP-2
15815855|NCT04318730|Drug|Camrelizumab|Camrelizumab was administered 200mg iv every 3 weeks, Apatinib was administered 250 mg p.o. qd.
15815856|NCT04318717|Drug|Pembrolizumab|Pembrolizumab is commercially available
15815857|NCT04318717|Radiation|Hypofractionated radiation therapy|It is preferred to leave at least 48 hours between fractions. Daily imaging to verify accurate set-up is mandatory.
15815859|NCT04318691|Biological|Blood sampling|Blood sampling at baseline and at day-3 (10 ml, EDTA tube), test of NETs.
15815860|NCT04318691|Procedure|Bronchoalveolar lavage|Bronchoalveolar lavage at admission to the ICU with analysis of cytological, bacteriological, viral and anatomopathological, and test of NETs.
15815861|NCT04318678|Drug|CD123-CAR T|To treat relapsed/refractory CD123+ AML, B-ALL, T-ALL or BPDCN patient population that needs new cancer-directed therapies.
15815862|NCT04318678|Drug|Cyclophosphamide|Cyclophosphamide is a nitrogen mustard derivative. It acts as an alkylating agent that causes cross-linking of DNA strands by binding with nucleic acids and other intracellular structures, thus interfering with the normal function of DNA.
15815868|NCT04318639|Combination Product|Donepazil|"Donepezil: Subjects will take 5 mg/day of donepezil in the evening for first 4 weeks, then 10 mg/day of donepezil in the evening until week 13.
~Cognitive remediation therapy (CRT): This study employs a computerized program (BrainHQ) for cognitive enhancement. Participants use their program for one hour per session, up to five sessions per week, over 13 weeks (maximum of 65 sessions). They may training on site or at another quiet location of their choice."
15815869|NCT04318626|Drug|PMPBB3|F-18 PMPBB3 PET Imaging
15815870|NCT04318626|Drug|THK5351|F-18 THK5351 PET Imaging
15815871|NCT04318600|Drug|human amniotic mesenchymal stem cell|human amniotic mesenchymal stem cell (hA-MSC) for the treatment of lupus nephritis patients with WHO class III, IV or V LN were given hA-MSC (Peripheral intravenous infusion, dose 1×106/kg cells, once every month for three times).
15815872|NCT04318587|Diagnostic Test|Allosure|Blood is collected from the patient, packaged, and shipped at ambient temperature to CareDx for testing. Donor-derived cell-free DNA is measured via targeted amplification and sequencing of a set of carefully selected and validated SNPs. The AlloSure bioinformatics software calculates the percent dd-cfDNA in the sample tested and applies the QC criteria. The AlloSure results will be compared to the episodes of acute rejection diagnosed by transbronchial biopsy and BOS/CLAD diagnosed by spirometry in the subjects medical records. Transbronchial biopsies and spirometry are standard of care for lung transplant recipients.
15815873|NCT04318574|Other|Balance, Agility, Strengthening Exercise (BASE) Class|The BASE class will be conducted twice weekly for 1.5 hours each session over a 6-week period and will include a 10-minute warm-up, 30 minutes of static and dynamic balance exercises, 20 minutes of lower extremity strengthening exercises, and a 10-minute cool-down. There will be weekly falls prevention and mobility enhancement education provided during the class.
15815874|NCT04318561|Diagnostic Test|Gallium-68 NODAGA-LM3 PET/CT|Twenty patients will take this intervention. They will be further divided into two sub-groups with the same interventional radiopharmaceutical (Gallium-68 NODAGA-LM3) but different scanning protocols (Protocol A and Protocol B). The first enrolled 8 patients will go with Protocol A, who will undergo serial whole-body PET/CT scans at multiple time points (5m, 10m, 20m, 40m, 1h, 2h) after administering 40ug/150-200MBq Gallium-68 NODAGA-LM3. Baseline safety assessment will be conducted right before the study. The following 12 patients will go with Protocol B, who will undergo a whole-body PET/CT scan at 1 hour after administering 40ug/150-200MBq Gallium-68 NODAGA-LM3.
15815875|NCT04318561|Diagnostic Test|Gallium-68 DOTA-LM3 PET/CT|Twenty patients will take this intervention. They will be further divided into two sub-groups with the same intervention radiopharmaceutical (Gallium-68 DOTA-LM3) but different scanning protocols (Protocol C and Protocol D). The first enrolled 8 patients will go with Protocol C, who will undergo serial whole-body PET/CT scans at multiple time points (5m, 10m, 20m, 40m, 1h, 2h) after administering 40ug/150-200MBq Gallium-68 DOTA-LM3. Baseline safety assessment will be conducted right before the study. The following 12 patients will go with Protocol D, who will undergo a whole-body PET/CT scan at 1 hour after administering 40ug/150-200MBq Gallium-68 DOTA-LM3.
15815876|NCT04318561|Diagnostic Test|Gallium-68 DOTATATE PET/CT|All patients have to do a Gallium-68 DOTATATE PET/CT scan (40ug/150-200MBq, 1h post-injection) for comparison on the next day of LM3 scan. Safety assessment and tolerability of the previous LM3 study will be conducted right before the study.
15815880|NCT04318535|Drug|Griseofulvin 500 mg|Griseofulvin 500 mg will be administered as an oral tablet once in each treatment period under fed condition.
15815881|NCT04318535|Drug|Griseofulvin 250 mg|Griseofulvin 250 mg will be administered as an oral tablet once in each treatment period under fed condition.
15815882|NCT04318535|Drug|Reference Griseofulvin 500 mg|Reference Griseofulvin 500 mg will be administered as an oral tablet once in each treatment period under fed condition.
15815883|NCT04318522|Device|Transcranial Direct Current Stimulator|Transcranial Direct Current Stimulation (tDCS) is a non-invasive brain stimulation device that can excite or inhibit the brain activity depending on the stimulation protocol. It has mainly two variants including conventional c-tDCS and High-Definition HD-tDCS.
15815884|NCT04318509|Dietary Supplement|GMPOWER|(casein) glycomacropeptide protein substitute for the dietary management of PKU from the age of 3 years
15815885|NCT04318496|Other|Press Tack Acupuncture|PYONEX Φ0.20×0.6 mm made by Seirin Corporation
15815886|NCT04318496|Other|Press Tack Placebo|PYONEX placebo sticker made by Seirin Corporation
15815887|NCT04318483|Other|survey|parents' telephone interview to collect medical history
15815888|NCT04318470|Diagnostic Test|mNGS|Metagenomic next generation sequencing for microbial DNA
15815889|NCT04318444|Drug|Hydroxychloroquine|Two tablets (400mg) twice daily on day 1; for days 2-5, they will be instructed to take one tablet (200mg) twice daily.
15815890|NCT04318444|Drug|Placebo oral tablet|Two tablets (400mg) twice daily on day 1; for days 2-5, they will be instructed to take one tablet (200mg) twice daily.
15815891|NCT04318431|Diagnostic Test|Data collection and rhinopharyngeal swab|Testing for SARS -Cov2 and other respiratory pathogens by PCR via nasopharyngeal swabbing and IgM/IgG rapid serology
15815892|NCT04318405|Drug|Iron isomaltoside 1000|Observation of real-life treatment with iron isomaltoside 1000
15815893|NCT04318392|Other|Breath Analysis|Breath analysis using the ReCIVA device will take place during each study visit.
15815894|NCT04318392|Other|Pulmonary Function Tests|Full Pulmonary Function Tests will be performed at baseline and during each study visit if not performed as part of routine clinical care.
15815895|NCT04318392|Other|Blood sampling and storage for genetic analysis|Additional voluntary consent will be sought for blood sampling and storage for genetic analysis at baseline.
15817142|NCT04308434|Other|CSD190601-22|Flavor variant CSD190601-22 of a 3.0% nicotine ENDS product
15815898|NCT04318392|Other|Sputum Culture|Sputum will be collected during each study visit if the patient can spontaneously expectorate and will be sent for routine microbial analysis as well as metagenomic sequencing.
15815899|NCT04318392|Other|Spirometry|Spirometry will be performed on all healthy controls prior to enrolment into the study
15815900|NCT04318379|Biological|HCVax|HCVax is a lentiviral vector encoding several HCV antigens
15815901|NCT04318366|Other|Observational Study|Not required
15815902|NCT04318353|Other|early enteral feeding within 2 days postoperative|Enteral feeding within 2 days postoperative
15815903|NCT04318340|Other|Tapered applicator|An applicator inserted in 2 steps that tapers at the distal vagina
15815904|NCT04318340|Other|Standard applicator|A 2.6 cm standard applicator is inserted and sized up to a standard 3 cm applicator if tolerable.
15815905|NCT04318327|Biological|PHE885|Infusion
15815906|NCT04318314|Diagnostic Test|COPAN swabbing and blood sample collection|COPAN swabbing of nostrils and/or oropharynx and blood sample collection
15815907|NCT04318288|Other|Observational|Observational
15815908|NCT04318262|Biological|Determination of the clinical and biological characteristics|"clinical data: types of infections (skin and soft tissues, bone and joint, bacteraemia, endocarditis…), delay between clinical signs and hospitalization, number of days of fever, number of days of hospitalization, infectious complications…
~biological data: Haemoglobin, Leucocytes, Neutrophils, Creatinine clearance, CRP…"
15815909|NCT04318262|Biological|Description of the antibiotic resistance profile|Determination of MICs of the major anti-staphylococcal antibiotics by the Sensititre technique
15815910|NCT04318262|Biological|Molecular epidemiology of S. lugdunensis infections|Genome sequencing (Illumina technique)
15815911|NCT04318249|Behavioral|Assisted Relaxation Therapy|This intervention includes using a smartphone application called mPhenomic that helps with breathing techniques and sleep.
15815912|NCT04318249|Behavioral|Modified Assisted Relaxation Therapy|This intervention includes using a smartphone application called mPhenomic that is modified to help with breathing techniques and sleep.
15815913|NCT04318236|Behavioral|HERMES (Online Self-Help Intervention based on problem-solving therapy)|"The Online Self-Help Intervention is an online program based on the problem-solving therapy (an evidence based approach of psychotherapy). All participants will receive the exact same intervention.
~However, what will be experimentally varied are the four listed interventions."
15815914|NCT04318223|Drug|Palbociclib|Patients will be enrolled into the study and assign to receive Palbociclib 125 mg/day orally for 3 weeks followed by 1 week off plus fulvestrant 500 mg intramuscularly on Days 1 and 15 of Cycle 1, every 28 days (+/- 7 days) thereafter starting from Day 1 of Cycle 1
15815915|NCT04318210|Drug|Tenofovir Disoproxil Fumarate 300 mg + Emtricitabine 200 mg|
15815916|NCT04318197|Other|Personalized rehabilitation program with electrostimulation|Patient with knee arthroplasty indication. After clinical assessment and a MRI measurement of muscle volume, patients start a 2 hours daily rehabilitation including 2 times 20 minutes of electrostimulation of atrophied muscles, 3 days per week during 4 weeks.
15815917|NCT04318197|Other|Global rehabilitation program|Patient with knee arthroplasty indication. After clinical assessment and a MRI measurement of muscle volume, patient start a 2 hours daily rehabilitation targeting muscles groups with strengthening and stretching exercises, 3 days per week during 4 weeks.
15815918|NCT04318184|Procedure|Aerobic exercise|The aerobic exercise protocol was performed 3 times a week for 3 months on the treadmill. Loading periods were performed according to the heart rate maximum using the Karvonen formula (%60-80 Heart rate maximum)
15815919|NCT04318171|Device|3D Imaging.|"When the normal Doppler assessment is done following nationally approved protocol for scanning Carotid arteries, lower and upper limb arteries, AVF and Vein mapping. PIUR tUS infinity system 3D Bluetooth motion sensor which is linked to video transmission box will be used to scan the patient's common carotid artery (CCA), internal carotid artery (ICA) and external carotid artery (ECA) in transverse view to obtain the following measurements:
~Plaque volume where detectable.
~Max area stenosis.
~Volumetric stenosis.
~Measured length.
~3D GSM. The entire assessment should not take more than 45 minutes."
15815920|NCT04318158|Drug|Bupivacaine|single shot US guided TAP block using 20 ml bupivacaine 0.25%.
15815921|NCT04318158|Drug|Dexmedetomidine|Single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg dexmedetomedine on each side.
15815922|NCT04318158|Drug|Fentanyl|Single shot US guided TAP block using 20 ml bupivacaine 0.25% + 50 µg fentanyl on each side.
15815923|NCT04318145|Drug|PL-3994 Aqueous Intravenous Solution Dose Ascention|Following appropriate dilution, PL-3994 will be injected intravenously by site personnel as a bolus dose followed by continuous infusion
15815924|NCT04318145|Drug|PL-3994 Aqueous Intravenous Solution Single Dose|Following appropriate dilution, PL-3994 will be injected intravenously by site personnel as a bolus dose followed by continuous infusion
15815925|NCT04318106|Device|Precision tinted spectacle lenses|Precision tinted spectacles lenses (Cerium Technologies TM)
15815926|NCT04318093|Drug|BMS-986259|Specified dose on specified days
15815927|NCT04318093|Other|Placebo|Specified dose on specified days
15815928|NCT04318080|Drug|Tislelizumab|200 mg intravenously (IV) every 3 weeks (Q3W)
15815929|NCT04318067|Drug|Melatonin 3 mg|Melatonin 3 mg is given ones a day - at bedtimes for 6 month
15815930|NCT04318054|Other|Ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health.|fibromyalgia patients consulting in Grenoble Alps University Hospital who will practice an ambulatory activity combining rehabilitation and therapeutic education, using an Intelligent Electric Bike for the Health during 8 weeks (2 times by week).
15815931|NCT04318041|Drug|Artrodar|"Diacerein (Artrodar):
~D1-D28 (1 month): Artrodar (50 mg) 1 x 1 with evening meal D29-end of study (23 months): Artrodar (50 mg) 1 x 2 with meal"
15815932|NCT04318041|Drug|Placebos|"Placebo:
~D1-D28 (1 month): Placebo 1 x 1 with evening meal D29-end of study (23 months) Placebo 1 x 2 with meal"
15815933|NCT04318028|Radiation|7 Tesla Magnetic Resonance Imaging|Undergo 7 Tesla MRI
15815934|NCT04318015|Drug|Hydroxychloroquine|All treatment will be administered orally.
15815935|NCT04318015|Drug|Placebo oral tablet|All placebo will be administered orally
15815936|NCT04318002|Biological|RH5.1/Matrix-M|3 doses of RH5.1/Matrix-M at different concentrations: RH5.1(10µg)/Matrix-M (50µg), RH5.1(50µg)/ Matrix-M (50µg), RH5.1(10µg)/ Matrix-M (25µg), RH5.1(50µg)/ Matrix-M (25µg)
15815937|NCT04317989|Other|Practice Facilitation|"Implementing evidence-based protocols and the use of clinical algorithms (for screening, counseling, referral, and MAT) to engage the entire clinical team in a high standard delivery of care.
~Promoting a strong use of decision support tools and templates to support the practice workflow.
~Optimizing the use of the electronic health record (EHR) to pull clinical data on a monthly basis to guide the change process.
~Developing patient registries (e.g., for those identified to have AUD) to identify needed care
~Proactive, team-based care with assigned roles and responsibilities to prepare the clinical team to develop needed care and engage patients throughout the entire visit process.
~Enhancing the understanding of available counseling and referral resources to ensure that practices are confident that they have appropriate evidence-based intervention options.
~For practices where telehealth is provided, protocols for scheduling and utilizing telehealth services."
15815938|NCT04317989|Other|Embedded Telehealth Services|Establishment within participating practices of video conferencing infrastructure where patients identified as having unhealthy alcohol use may receive counseling from remotely located providers.
15815939|NCT04317976|Other|paralaryngeal pressure|cricoid pressure with paralaryngeal pressure by fingertips applied under ultrasound guidance
15815940|NCT04317976|Other|cricoid pressure|cricoid pressure by fingertips applied under ultrasound guidance
15815941|NCT04317963|Biological|Bezlotoxumab|Bezlotoxumab 10 mg/kg IV infusion in addition to standard CDI treatment
15815942|NCT04317963|Drug|Standard CDI treatment|Standard CDI treatment includes one or a combination of oral vancomycin, oral vancomycin taper and/or pulse, fidaxomicin, and fidaxomicin taper and/or pulse
15815943|NCT04317950|Other|Vojta|Reflex locomotion stimulus
15815944|NCT04317950|Other|Sham|sham stimulus
15815949|NCT04317924|Device|Polyglycolic acid felt|Neoveil is a polyglycolic acid felt that has been shown to decrease the incidence of prolonged air leak after lung resection in Japan.
15815950|NCT04317924|Other|Standard of care|Standard of care after air leak post lung resection
15815951|NCT04317911|Other|Catheter Ablation|Patients with preserved ejection fraction presenting for catheter ablation via of atrial fibrillation are included in this study and prospectively observed regarding arrhythmia-related, functional and biomarker-associated outcomes.
15815952|NCT04317898|Procedure|serratus plane block by ultra-sound|To perform Serratus block, patients will be placed in the lateral decubitus position with the affected side facing up, or in the prone position with the affected side facing the operator . After sterile preparation, a linear ultrasound probe will be utilized to identify the latissimusdorsi and serratus anterior muscles in a sagittal plane. The plane superficial to the serratus anterior muscle and below the latissimusdorsi muscle will be identified. The skin will be topicalized with 1 mL of 1% lidocaine using a 30-gauge needle. Using an in-plane approach, a 25-gauge 1.5-cm needle will be used to inject a total of 20-mL of 0.25% bupivacaine with 80 mg of triamcinlone under direct ultrasound visualization.
15815953|NCT04317898|Procedure|paravertebral block by ultra-sound|TPVB will be given using high frequency linear US transducer, place the probe parallel to the vertebral spine at T2 level and shifted 2-3 cm laterally to obtain the appropriate visualization. Following the identification of plura, transverse process and paravertebral space, the needle will be inserted in caudocranial direction using in-plane approach. Confirm negative vessel or pleural breach via aspiration then proceed with local anaesthetic 10ml of 0.25% bubivacine and 80mg triamcinlone slowly; the pleura will be seen to be pushed downward.
15815954|NCT04317885|Biological|CD19/CD20-directed CAR-T cells|Autologous 2nd generation CD19/CD20-directed CAR-T cells, single infusion intravenously
15815955|NCT04317872|Drug|High dose of peri-operative intravenous dexamethasone|25mg aacidexam is administered during induction followed by 10mg on the ward after 12 hours
15815956|NCT04317872|Drug|Low dose of peri-operative intravenous dexamethasone|10mg aacidexam is administered during induction followed by placebo on the ward after 12 hours
15815957|NCT04317859|Behavioral|Behavioural Activation|Behavioural Activation (BA) is a therapy previously shown to be effective in depressive disorders. This form of therapy involves modification of activities in order to change perceptions of specific situations, thereby improving mood. The BA treatment program will consist of 18 two-hour visits over 14 weeks (twice weekly group visits for the first 8 weeks, followed by two individual visits over 6 weeks).
15815958|NCT04317846|Other|Intravenous administration of vasodilatory drugs|Administration of the vasodilatory drugs in a different pattern than intra-arterially
15815959|NCT04317833|Drug|SSS17|SSS17 is a novel small molecule compound which stimulates erythropoiesis through inhibition of hypoxia-inducible factor- prolyl hydroxylases( HIF-PH). It is being developed for the treatment of anemia in patients with chronic kidney disease.
15815960|NCT04317833|Drug|Placebo|matched placebo
15815961|NCT04317820|Behavioral|Deep Brain Reorienting (DBR)|Trauma processing through DBR involves bringing up a traumatic memory and encouraging the client to focus on tensions arising in the muscles of the shoulders, neck, head and face (i.e., those involved in orienting toward a threatening person/event). The rationale is as follows: Physiologically, orienting to a stimulus, whether external or in the mind's eye, comes before any affective response to it. Here, it is hypothesized that there is activity in certain midbrain structures , i.e.,Superior Colliculi (SC) and Periaqueductal Gray (PAG). The deep layers of the SC bring on a brief (orienting) tension in the neck as well as preparing for eye movements, which is later followed by the processing of raw affect in the PAG. In session, if we can attend to this tension - even if we have to backtrack from the emotion that follows - we can establish an anchor in the body that precedes the affect and is hypothesized to protect against emotional overwhelm.
15815962|NCT04317807|Drug|Levetiracetam Pill|Levetiracetam is an anticonvulsant that is frequently used to treat epilepsy in children and adults due to its superior tolerability, ease of use and excellent safety profile. It is rapidly absorbed and rapidly crosses the blood-brain barrier. Levetiracetam does not affect metabolism of antipsychotic drugs and may normalize hippocampal hyperactivity by decreasing excessive glutamatergic and dopaminergic transmission, thereby making it an ideal agent to test the hypothesis that reducing excessive hippocampal activity may enhance treatment of early psychosis and prevent antipsychotic toxicity. Levetiracetam will be administered in 500 mg capsules twice a day.
15815963|NCT04317807|Other|Placebo|The placebo pill (sugar pill) will look just like the levetiracetam pill but does not contain levetiracetam. Placebo will be taken along with optimal antipsychotic medication selected by either the outpatient provider or the hospital staff responsible for the participant's care. Participants will be instructed to take the placebo pill twice daily for 12 weeks.
15815964|NCT04317794|Drug|Nusinersen Sodium Injection|Administered as specified in the treatment arm.
15815965|NCT04317781|Biological|Tagraxofusp-erzs|Given IV
15815966|NCT04317768|Behavioral|Basic oral health education and motivation|Subjects will receive verbal oral hygiene instructions using a model to demonstrate only once at the beginning of the study, no further motivation or educational seminars will be done.
15815967|NCT04317768|Behavioral|Intensive oral health education and motivation|Subjects will be educated and motivated by an intensive program consisting of verbal instructions, PowerPoint lectures, posters and live demonstrations about oral hygiene instructions and teaching the proper way to brush the teeth. These will be reinforced by the investigator at intervals of 1 week, 1 month, 3 months, 6 months and 1 year.
15815968|NCT04317755|Behavioral|AdhaFULL body image comics|AdhaFULL is a comic-book series co-created by BBC Media Action and UNICEF, which follows the journey of 3 adolescents as they solve cases related to important issues (e.g., under-age marriage, nutrition, gender-stereotypes, peer pressure etc). The comics aim to raise awareness and encourage adolescents to take action against these issues. There are 6 different comics based on AdhaFULL, which target issues relating to gender stereotypes and appearance concerns amongst adolescents in rural India. Specifically, they focus on gender prejudice (Comic 1),societal appearance ideals (Comic 2), media literacy (Comic 3), appearance comparisons (Comic 4), appearance-related conversations and teasing (Comic 5), and promoting 'body activism' (Comic 6). At the end of each comic, the teacher will facilitate one or two activities with the students based on the comic.
15815969|NCT04317742|Device|Sleep Healthy Using the Internet (SHUTi) Intervention Group|"SHUTi is a fully automated, interactive and tailored web-based program that incorporates the primary tenets of face-to-face CBT-I, including sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention. Intervention content is presented in six Cores, metered out over time."
15815970|NCT04317742|Device|Online Patient Education (PE) Control Group|The online PE program provides static information about: insomnia symptoms; the impact, prevalence, and causes of insomnia; when to see a doctor; and basic lifestyle, environmental, and behavioral strategies to improve sleep.
15815971|NCT04317729|Device|Fujirebio INNOTEST® HCV Ab IV assay|Enzyme Immunoassay
15815972|NCT04317716|Behavioral|fall prevention program|The intervention consists of the fall prevention program for ambulatory and non-ambulatory people with multiple sclerosis. The program will be group-based with 6-8 participants, led by a facilitator, and performed online. It comprises six two-hour sessions held once a week, and a booster session held eight weeks after the sixth session. In addition they will receive a brochure about falls and fall risk factors.
15815973|NCT04317716|Other|Brochure about falls and fall risk factors|Control-group participants will receive a brochure about falls and fall risk factors, posted by mail. They will be advised to live their normal lives and receive usual care at the discretion of their physician since no treatment can be considered the gold standard.
15815974|NCT04317703|Drug|Gemigliptin tartrate sesquihydrate and metformin|Each tablet contains gemigliptin tartrate sesquihydrate 68.9 mg (equivalent to gemigliptin pure free base 50 mg) and metformin hydrochloride 1000.0 mg.
15815975|NCT04317703|Drug|gemigliptin 50 mg and metformin hydrochloride 1000 mg prolonged release|"Zemiglo Tablet 50 mg: Each tablet contains gemigliptin tartrate sesquihydrate, equivalent to 50 mg gemigliptin.
~Glucophage XR 1000 mg: Each tablet contains metformin hydrochloride 1000 mg (equivalent to 780 mg of metformin base)."
15816028|NCT04317235|Drug|Ropivacaine 0.5% Injectable Solution|Is to put 3 ml or 5 ml and show the difference
15815976|NCT04317677|Other|Study of the effect of bladder voiding on sleep fragmentation during day and night sleep|Vigilance state of babies will be continuously recorded during the first 24 hours of hospitalization by polysomnography and actigraphy. In parallel, bladder voiding episodes will be detected with an innovative device placed on babies diapers.
15815977|NCT04317664|Combination Product|In-vehicle device|The Azūga™ in-vehicle driving feedback technology, which consists of a pager-sized device plugged into the vehicle's on-board diagnostic port (installed in the teen's car) and a smartphone app (downloaded on the teen's smartphone), will be installed/downloaded. Three types of feedback will be provided to intervention teens: 1) Direct audio feedback from the installed device; 2) Detailed cumulative driving data; and 3) A customized biweekly driving summary report.
15815978|NCT04317664|Behavioral|Parent Communication|An individualized virtual training in communication strategies about driving safety along with a booster session will be delivered by a traffic safety communication specialist to subjects in the Feedback and Parent Communication Group. Intervention parents in this group will also be provided with access to an online parent-teen safe driving communication guide.
15815979|NCT04317638|Other|Lipid profile|3 ml of venous blood from the breastfed and infants and mothers of the breastfed and mixed fed infants will be taken under aseptic precautions for determination of triglycerides (TG), cholesterol, high density lipoprotein (HDL), very low density lipoprotein (LDL) at the age of 14 ± 2 weeks and the age of 6 months.
15815980|NCT04317625|Diagnostic Test|mpMRI scanning|The patients whose PSA levels are between 2.5 and 4.0ng/ml will be recommended to mpMRI scanning at first but not biopsy or active surveillance.
15815981|NCT04317612|Other|Active berry product|Subjects should consume the active product containing nordic berries daily during the 12 week intervention period.
15815982|NCT04317612|Other|Reference product|Subjects should consume a reference product (isocaloric to active product) daily during the 12 week intervention period.
15815983|NCT04317599|Other|Non Interventional study|Non Interventional study
15815985|NCT04317573|Device|Personalised card|An individualised card containing the patient's eye drops regime was printed for the patient after his/consult with the physician to be brought home.
15815986|NCT04317560|Procedure|Arthrocentesis|2 guiding points have been created on the skin. The first one is 10 mm in front of the tragus and 2 mm below the tragus line. The second guide point is on the same line, 20 mm in front of the tragus and 6 mm below. After the auriculotemporal nerve block was made, the first 20 gauge needle was inserted from the first point. 2mL Ringer's Lactate solution is injected into the temporomandibular joint area, and then a second 20 gauge needle is entered from the second guide point determined before and pressurized washing is performed with 100 mL of 5% lactate solution to enter the first needle and exit from the second needle.
15815987|NCT04317560|Procedure|injectable platelet rich fibrin injection|2 tubes of blood were collected from the patients with the help of vacuumed 10 mL special liquid PRF tubes (Choukroun I-PRF Collection Tubes, Dr. Choukroun) after arthrocentesis. Blood tubes were centrifuged at 700rpm for 3 minutes. 3 mL of liquid PRF was obtained at the top of each tube. I-PRF was injected into the joint areas of all patients in the experimental group, with a maximum dose of 2 mL per joint.
15815988|NCT04317547|Behavioral|Steering Teens Safe (STS)|The goal of STS is to provide intervention parents with guidance and communication skills, which will enable parents to effectively communicate with their teens about specific driving safety topics (e.g., speeding, seatbelt use, distracted driving). Our proposed parent training has two components: an individualized virtual communication training (provided to parents via Skype by a trained research team member) and a parent-teen safe driving communication guide (available online).
15815989|NCT04317547|Behavioral|Driving Feedback Technology.|The driving feedback technology will include the Azūga™ in-vehicle device and smartphone app.
15815991|NCT04317521|Device|Use of EKO Core and EKO Duo electronic stethoscopes|Listen to heart murmurs
15815992|NCT04317508|Drug|Topicale GelPatch (Benzocaine 18%)|Intervention group
15815993|NCT04317508|Drug|Benzocaine oral gel 20%|control group
15815994|NCT04317495|Other|Computerized Cognitive Training (CCT)|After having four rTMS sessions without CCT, the patients will perform CCT (starting day 5) during the rTMS session, which typically last from 20-40 minutes. A course of rTMS therapy includes from 25-36 treatments, given daily, until the last 5-6 treatments, given as a 'taper' over 2 weeks. CCT will be paired with rTMS up until the taper begins. In addition, they will have assessments prior to and after the therapy.
15815995|NCT04317482|Behavioral|Standard social stress task|Participants will be asked to respond in detail to three scenarios. This is a standard social stressor task. Participants may be prompted by an experimenter. However, the participant will receive no verbal nor nonverbal feedback.
15815996|NCT04317482|Behavioral|Stressful experience in the ED|Participants will be asked to imagine and then describe both feelings and bodily sensations experienced at their most stressful ED visit, in order to help them more fully re-experience the situation. In this regard, the second condition is more similar to stress imagery employed by Sinha et al, which elevated cortisol to a greater degree than a social stressor task. Participants may be prompted by an experimenter. However, the participant will receive no verbal nor nonverbal feedback.
15815997|NCT04317469|Diagnostic Test|VWF measurement|Plasma levels of both vWF and IL.6 were be measured on T=0 i.e. (at start of the study once the patient considered to be risky for A.R.D.S development to obtain their baseline levels), T=48 (after 48 hours), and T=72 (after 72 hours).
15815998|NCT04317456|Device|Hearing Aids and Hearing Implants|Hearing Aids and Hearing Implants (age at first fitting and implantation and aided audibility)
15815999|NCT04317456|Behavioral|Family Centred Early Intervention|Family Centred Early Intervention
15816000|NCT04317443|Procedure|Super-mini percutaneous nephrolithotomy (SMP)|SMP will be performed under general anesthesia in prone/supine position. Renal puncture will be performed under ultrasound/fluoroscopy guidance based on the preference of the participating surgeon. Tracts will be dilated to 14 Fr. Stone fragmentation will be performed with holmium laser and fragments will be extracted with the active suction system. For the exit strategy, placement of a nephrostomy tube or JJ stent will be decided by the participating surgeon.
15816063|NCT04316936|Drug|Dextenza (dexamethasone ophthalmic insert) 0.4mg|intracanalicular dexamethasone insert
15816001|NCT04317443|Procedure|Extracorporeal Shock Wave Lithotripsy (ESWL)|ESWL will be performed under sedation/analgesia, shock wave lithotripsy parameters will be determined based on the device and the settings of local center. For patients requiring multiple sessions, maximum 3 (or more) sessions will be allowed. Ureteral stenting prior to ESWL will be performed based on the decision of the participating center.
15816002|NCT04317430|Drug|Niclosamide|Niclosamide tablets 1 gram once daily
15816003|NCT04317430|Drug|Placebo oral tablet|lactose tablets
15816005|NCT04317404|Drug|40 mg Triamcinolone acetonide|Unilateral knee steroid injection
15816006|NCT04317391|Behavioral|Pain management program|Mindfulness based stress reduction
15816007|NCT04317378|Device|Braun thermoscan /, IRT 6520|The temperature will be measured in both ears with an ear thermometer. Practically, we will measure the temperature twice when generel anaesthsia is established, and immidiately before and after the MRI scan.
15816008|NCT04317365|Other|Women receiving extra remembering by healthcare|Women receiving extra remembering by healthcare in covid infection
15816009|NCT04317352|Procedure|MVR|Multivisceral resection was considered when the exeresis of an organ other than the pancreatic body-tail and / or spleen was performed.
15816010|NCT04317339|Drug|Zhigancao Tang granule|"Zhigancao Tang: Dissolve Zhigancao Tang granule in 200ml hot water, twice a day,12 weeks, oral.
~Standard heart failure treatment，including ACEI/ARB/ARNI, aldosterone antagonists, beta blockers, nitrate esters and diuretics as needed."
15816011|NCT04317339|Drug|Zhigancao Tang placebo granule|"Zhigancao Tang placebo: Dissolve Zhigancao Tang placebo granule in 200ml hot water, twice a day,12 weeks, oral.
~Standard heart failure treatment，including ACEI/ARB/ARNI, aldosterone antagonists, beta blockers, nitrate esters and diuretics as needed."
15816012|NCT04317326|Procedure|"Lifestyle modifications group (Control)"|It will consist of a 1,000-calorie/day diet and to maintain proper sleep hygiene and habits (avoid supine decubitus position, maintain regular sleep habits and exercise, not take sedatives, stimulants, alcohol, tobacco or heavy meals within four hours before bedtime). Oxygen therapy can be prescribed by the treating team using standard criteria (awake PaO2 <55 mmHg or room air oxygen saturation below 88% (Masa JF et al. J Clin Sleep Med. 2016 ;12:1379-88). The treatment period will be three months.
15816013|NCT04317326|Procedure|Automatic NIV|In addition to lifestyle modification and oxygen (if required), the ventilator will be adjusted to a range of predetermined parameters with the intelligent ventilation mode (pressure of intelligent support with guaranteed volume with automatic backup frequency) with the following adjustment: maximum pressure: 35 cmH2O; respiratory rate: automatic; maximum pressure support: 18 cm H2O; minimum pressure support: 4 cmH2O; maximum EPAP pressure: 15 cmH2O; minimum EPAP pressure: 4 cmH2O; and tidal volume (Vt) based on 8-10 ml/kg of predicted body weight, being able to be modified according to tolerance.The treatment period will be three months.
15816014|NCT04317326|Procedure|CPAP treatment group|In-laboratory polysomnographic CPAP titration will be performed according to published guidelines for CPAP titration (SEPAR guideline or AASM guideline).In addition to lifestyle modification and oxygen (if require), a home titrated CPAP therapy will be initiated.The treatment period will be three years.
15816015|NCT04317326|Procedure|NIV treatment groups|In-laboratory polysomnographic NIV titration will be performed according to published guidelines In addition to lifestyle modification and oxygen (if required) home NIV therapy with fixed pressures will be started. The ventilator mode will be a bilevel pressure in S/T mode. The ventilator adjustment will be firstly performed in awake situation and then during sleep by means of a PSG. The treatment period will be three years.
15816017|NCT04317300|Drug|Varenicline|Dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 11 weeks of treatment.
15816018|NCT04317300|Other|brief behavioral therapy|brief behavioral therapy
15816019|NCT04317287|Dietary Supplement|Cardio formulation|Tomato-based formulation with dietary supplement softgels
15816020|NCT04317287|Dietary Supplement|Placebo|Placebo softgels
15816021|NCT04317274|Behavioral|Good high cholesterol video|The short video illustrated key components of a high quality shared decision making conversation between a doctor and patient actor around treatment of high cholesterol.
15816022|NCT04317274|Behavioral|Poor high cholesterol video|The short video illustrated a typical conversation between a doctor and patient actor that did not cover key aspects of share decision making around treatment of high cholesterol.
15816023|NCT04317274|Behavioral|Good colon cancer screening video|The short video illustrated key components of a high quality shared decision making conversation between a doctor and patient actor around screening for colorectal cancer.
15816024|NCT04317274|Behavioral|Poor colon cancer screening video|The short video illustrated a typical conversation between a doctor and patient actor that did not cover key aspects of share decision making around screening for colorectal cancer.
15816025|NCT04317261|Diagnostic Test|Xpert Bladder Cancer Monitor (Xpert Monitor) test and assay of urinary metabolomics (gene expression of CRAT and SLC)|Urine sample is evaluated for RNA and urinary metabolites
15816026|NCT04317248|Drug|Cyclophosphamide|Intravenous drip，250mg/m^2 per time，two days before each times of MSDCV therapy，total 6 times, in order to improve the immunosuppressive microenvironment of tumor，reduce CD4+CD25+FOXP3+regulatory T cells (Tregs）
15816027|NCT04317248|Biological|Multiple Signals loaded Dendritic Cells Vaccine|one time every 4 weeks during 0 weeks to 20 weeks, about 5*10^7 cells per time, intravenous driptotal 6 times;
15816029|NCT04317222|Device|eCRRT|"eCRRT was define as:
~Initiated within the first 24 post-transplant hours;
~High volume (35-50ml/kg) hemofiltration;
~Continuous at least 12 hours per day for 3 days;
~Standard treatment"
15816030|NCT04317209|Drug|SHR0410|administered intravenously
15816031|NCT04317209|Drug|Placebo|administered intravenously
15816032|NCT04317183|Drug|chamomile topical oral gel|Chemical constituents of chamomile, such as bisabolol, chamazulene, and the flavonoids apigenin and luteolin, possess anti-inflammatory properties.
15816033|NCT04317183|Drug|Miconazole Topical Gel|topical anti fungal agent
15816034|NCT04317183|Drug|BBC oral spray|Topical anesthetics and anti-inflammatory agent
15816035|NCT04317183|Drug|Oracure gel|Topical analgesic gel
15816036|NCT04317170|Other|Music|Participants will be played Frederic Chopin's piano sonatas through a headphone device prior to and during injection of local anesthesia during their routine standard of care dermatologic procedure
15816037|NCT04317157|Dietary Supplement|Caffeine|Specific dosage of caffeine for each participant (6 mg.kg-1).
15816038|NCT04317157|Other|Placebo|Placebo pill.
15816039|NCT04317144|Behavioral|Web-based follow-up programme.|Participants who are randomized to the intervention-group will have access to web-based follow-up for one year. The programme includes short films of equipment used in intensive care e.g. ventilator, suction-device. Continous renal replacement therapy , central vein catheter among other things. About 15 short films with icu-staff talking and show how the equipment works and alarm sounds. The intervention also includes lectures about how the ICU works and what problems a critically ill patient can suffer from post-icu. There is a built-in conversation tool in the programme that can be used both by the participant and the staff who works with the follow-up programme. Questionnaires is sent out 2,6 and 12 month post-icu. The questions include PTSD, Depression, QoL and physical activity. At the end of the study, participants are sent a questionnaire asking for their experience using the web-based follow up programme.
15816040|NCT04317144|Behavioral|No follow-up|"Participants randomized to no follow-up receive e-questionnaires 2, 6 and 12 months post-ICU care. The questions are the same as in web-based follow-up intervention group and include PTSD, Depression, QoL and physical activity."
15816041|NCT04317131|Diagnostic Test|Research Diagnostic Criteria of Functional Disorders of the Masticatory System BKD / ZCURNŻ - Polish version|Interview and clinical examination of stomatognathic system based on standardized tool BDK/ZCURNŻ.
15816042|NCT04317131|Device|Clinical examination of the stomatognathic system (structural and functional)|Examination with the use of JMA+Analyser (Jaw Motion Analyser) to analyse movement and function of the temporomandibular joints, mandibular position, condyle position (EPA), and access the muscle action potentials through bipolar skin surface electrodes EMG, assessment of occlusion by visual method according to Angle Classification.
15816043|NCT04317131|Device|3D examination of the body posture|Comprehensive, three- dimensional examination of the body posture (static and dynamic) in the area of the spine, lower limbs and feet, performed by photogrammetric method (4th Generation MORA) and non- invasive image acquisition technology with the aid of infrared (Kineod) and The CQElektronik system.
15816044|NCT04317131|Device|Functional assessment of the spine and lower limbs|Functional assessment of the spine and lower limbs mobility trough a wireless motion sensor Moover.
15816045|NCT04317131|Device|Complementary tests|Anthropometric measurements (height, weight, waist and hip circumference, skin folds), foot pressure on the ground and body balance accessed by pedobarograph FreeMed, body mass components measured by the Tanita MC 980 MA (BIA method), evaluation of 7-days of physical activity by accelerometer ActiGraph GT3X-BT, blood pressure measurement by Medel Connect Cardio MB 10 monitor.
15816049|NCT04317092|Drug|Tocilizumab Injection|Tocilizumab 8 mg/kg (up to a maximum of 800mg per dose). A second administration (same dose) can be given after 12 hours if respiratory function has not recovered, at discretion of the Investigator.
15816050|NCT04317079|Dietary Supplement|Hydroxytyrosol|Administration of hydroxytyrosol in doses 15mg and 5 mg compared to placebo for 6 months
15816051|NCT04317079|Other|Diet|Consultation by a dietitian was offered to all participants
15816052|NCT04317066|Drug|Pembrolizumab|Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.
15816053|NCT04317053|Behavioral|RELAY|Relay is a novel program that engages and intervenes with individuals in the ED following an opioid OD and for the next 90 days, with the goal of preventing subsequent OD events. Relay is delivered by trained peer navigators, who are DOHMH staff with lived substance use experience. Relay navigators provide counseling, linkage to services, and OD prevention education.
15816054|NCT04317040|Drug|CD24Fc|CD24Fc is given on Day 1.
15816055|NCT04317040|Drug|Placebo|Placebo is given on Day 1.
15816056|NCT04317027|Device|New Fighting Clothing|VO2max test Clothing examination- 2-hour walk in 6 kph/4% elevation under 30 degrees Celsius and 60% relative humidity
15816057|NCT04317001|Drug|Modafinil|Treatment will be with 100mg of modafinil for the two week primary phase of the study
15816058|NCT04317001|Drug|Placebo|placebo
15816059|NCT04316988|Diagnostic Test|Ultrasonography|A real time 2D ultrasound evaluation was done over the trachea of the patient.
15816060|NCT04316975|Other|Study Driven Procurement of Biopsies|Four research biopsies collected at the midpoint of current BE or IMC at Baseline and after reaching CEIM. Biopsies will be used to calculate ML scores both pre and post EET.
15816061|NCT04316962|Other|Complex cancer rehabilitation|"The program is conducted as group rehabilitation, organized by four hour weekly over 12 weeks (approximately 50 hours) with 8-10 participants in each group over three years. The program is located in Askøy Municipality's 'Health Central' and conducted by a multidisciplinary team.
~The content of the program is based on prior research and clinical experience, consisting of five elements:
~Individual goal-setting
~Physical activity (2 hours/week) focusing on balance/coordination, cardio and strength.
~Psychoeducation: Five teaching sessions and discussions focusing on physical activity, fatigue and late-effects, nutrition, coping, social support and work/studies. In addition, two sessions (first and last) will also include next of kin.
~Individual follow-up: Mandatory session at the start and end of the program, otherwise based on individual request and need.
~Peer support."
15816062|NCT04316936|Drug|Omidria|phenylephrine 1% and ketorolac 0.3% intraocular solution
15816068|NCT04316923|Diagnostic Test|Cardio-pulmonary exercise test (CPET)|CPET will be performed during the first and the last visit in the study group.
15816069|NCT04316923|Diagnostic Test|Cardiac biomarkers|Cardiac biomarkers will be assessed during each visit in the study group.
15816070|NCT04316910|Drug|General anesthetic|General anesthesia was induced as follows: 0.3 mg kg-1 intravenous (IV) etomidate, 2 mg IV midazolam, 0.4 μg kg-1 IV sufentanil, and 0.2 mg kg-1 IV cisatracurium. Anesthesia was maintained with an end-tidal concentration of 2-3 vol% sevoflurane and 0.2-0.3 μg kg-1h-1 sufentanil to maintain the bispectral index between 40 and 60.
15816071|NCT04316897|Device|Echocardiography|It is a an observational cross-sectional echocardiographic screening study in Assiut Governate conducted after seeking approval from the local institutional review board and human subjects' protection.
15816076|NCT04316858|Drug|Sodium phosphate|90ml of sodium phosphate will be added to 800ml of solvent( water or zero calorie carbonated drink) and taken in divided doses one day prior to procedure. Whole solution will be finished 3 -4 hours before colonoscopy.
15816077|NCT04316858|Dietary Supplement|Water|800 ml of water will be added to 90 ml of sodium phosphate to facilitate its intake by the patients preparatory to colonoscopy
15816078|NCT04316858|Dietary Supplement|Zero calorie carbonated drink|800 ml of zero calorie diet cola will be added to 90 ml of sodium phosphate to facilitate its intake by the patients preparatory to colonoscopy
15816079|NCT04316845|Diagnostic Test|18F-fluorocholine PET/CT|Patients undergo both 18F-fluorocholine PET/CT and Single isotope dual phase Tc-99m sestamibi scan (both planar scan and SPECT/CT)
15816080|NCT04316832|Behavioral|Mindfulness based cognitive training|The mindfulness based cognitive training will include three short mindfulness exercises: a) a breathing exercise, b) a body scan exercise, and c) a mindfulness attention exercise.
15816081|NCT04316832|Other|Control exercise|Participants will listen to the first chapter of the audiobook The Hobbit, JRR Tolkien.
15816082|NCT04316819|Other|Packed Promise Demonstration Benefits|Monthly: Home-delivered food box, nutrition education handout, and $15 monthly voucher for fruits and vegetables
15816083|NCT04316806|Dietary Supplement|Probiotic|Probiotic (dietary supplement) administrated once daily (u.i.d) for 8 weeks (3 billion cfus per day)
15816084|NCT04316806|Drug|Rifaximin|Antibiotic rifaximin consisting 400 mg capsules administrated twice daily (b.i.d) for 1week.
15816085|NCT04316793|Other|Dry needling|Intramuscular insertion of an OPTIMED 40mm x 0.3mm acupuncture needle in a trigger point of the infraspinatus muscle
15816086|NCT04316793|Other|Sham needling (SN)|Intradermal insertion of an OPTIMED 40mm x 0.3mm acupuncture needle over the infraspinatus region
15816087|NCT04316780|Other|Retrospective observational study- no intervention to occur.|Subject data will be grouped based on the anti-fibrotic medication at the time of lung transplant listing eligibility and when medication was stopped relative to the transplant.
15816088|NCT04316767|Behavioral|App Intervention|Participants will receive access to a self-care app for use on their smartphone. The app provides a suite of tools based on cognitive behavioral therapy and mindfulness. The app guides users through a variety of short lessons (3-5 minutes) that teach users to self-manage stress, mood, anxiety, and depression. Participants will be encouraged to use the app on a daily basis and will be able to use the app at their discretion.
15816089|NCT04316754|Other|music|"During angiography, the Intervention-1 group will listen to the music that the child wants to listen to. The Intervention-2 group will listen to the Arts of Fugue by Bach. No music will be played to the control group."
15816090|NCT04316741|Behavioral|Snapcoach|A brief motivational interviewing-based intervention combined with health coaching via social media for 4 weeks
15816091|NCT04316728|Device|VivaDiag™ COVID-19 lgM/IgG Rapid Test|VivaDiag™ COVID-19 lgM/IgG Rapid Test is an in vitro diagnostic for the qualitative determination of COVID-19 IgM and IgG antibodies in human whole blood (from vein or fingertip), serum or plasma
15816092|NCT04316715|Behavioral|Lifesteps for PrEP|Four weekly nurse delivered counseling sessions plus two optional booster sessions. Sessions last approximately 40-50 minutes each. Sessions employ cognitive behavioral (CBT) techniques, motivational interviewing (MI), and psychoeducation.
15816093|NCT04316715|Behavioral|Daily text message reminders|Participants get daily text messages on their cell phone reminding them to take their PrEP medication.
15816094|NCT04316702|Device|Hyperbaric oxygen therapy|60 HBOT sessions at 2 ATA 100% oxygen
15816095|NCT04316702|Drug|Cymbalta / lyrica|one of the two medications currently licensed for the treatment of FMS in Israel, i.e. Cymbalta and Lyrica.
15816096|NCT04316689|Biological|S-488210|S-488210 is a freeze-dried injectable formulation containing the following three peptides, S-488201 (a URLC10-derived peptide), S-488202 (a CDCA1-derived peptide) and S-488203 (a KOC1-derived peptide).
15816097|NCT04316689|Biological|S-488211|S-488211 is a freeze-dried injectable formulation containing the following two peptides, S-488204 (a DEPDC1-derived peptide) and S-488205 (an MPHOSPH1-derived peptide).
15816098|NCT04316676|Diagnostic Test|PET-MPI Protocol|Patients with suspected CAD who are referred to a clinical PET-MPI will undergo the standard clinical protocol applied in the Emory Nuclear Medicine department.
15816099|NCT04316676|Diagnostic Test|CT-MPI|"For the CT-MPI, dynamic volume CT myocardial perfusion applying the dynamic shuttle mode will be used to rapidly cover the entire cardiac anatomy during infusion of a contrast medium bolus for monitoring bolus passage through the left ventricular myocardium. The dynamic shuttle mode consists of an image acquisition during rapid, yet smooth back-and-forth movement of the CT scanner table, so that contrast media bolus passage can be evaluated within the entire left ventricle in a time-resolved fashion. This scan acquisition will be performed during pharmacologically induced stress and during rest conditions. CT-MPI studies will be contrast medium enhanced by 50-70 ml of iodinated contrast agent, administered at a flow rate of 5 mL/s."
15816153|NCT04316221|Other|Standar of care|frequent growth monitoring, general nutrition education, parasite treatment, and multiple micronutrient supplementation.
15816223|NCT04315740|Other|Particles from cooking|Generating fine and ultrafine particles from frying pork in an oven
15816100|NCT04316676|Diagnostic Test|CT-FFR|Coronary CT angiography (CCTA) will be performed for delineation of the coronary arteries, detection of potential coronary stenosis and FFR calculation. CCTA will be performed at rest following administration of intravenous contrast agent (50-70 mL of iodinated contrast material at a flow rate of 4-5 mL/s). A total radiation dose of approximately 8 millisievert (mSv) has expected to be administered with the stress/rest protocol to the patient. The total amount of contrast agent will not exceed 140 ml.
15816101|NCT04316676|Drug|Regadenoson|Pharmacological stress testing for the CT-MPI scan will be performed with a single injection of 0.4 mg of regadenoson (Lexiscan).
15816102|NCT04316663|Behavioral|Well-Being Intervention|The main aim of the well-being intervention is to reduce levels of distress through the promotion of psychological well-being. Key components of the intervention are self-monitoring of instances of well-being and what leads to their interruption (i.e., thoughts and behaviors), cognitive restructuring of interfering thoughts, and homework assignments to address dysfunctional behaviors and increase exposure to optimal experiences. Participants will become aware of their functioning based on six different dimensions of psychological well-being (i.e., self-acceptance, positive relations with others, autonomy, environmental mastery, purpose in life, and personal growth), and will be guided in finding a balance within each dimension.
15816103|NCT04316663|Behavioral|Sleep Hygiene|The main aim of sleep hygiene education is to provide participants with a set of behavioral and environmental recommendations intended to promote healthy sleep. During the intervention, participants will become aware of their own sleep patterns, will learn about healthy sleep habits, and will be encouraged to follow a set of recommendations to improve their sleep. Key components of the intervention are sleep hygiene and education.
15816104|NCT04316650|Behavioral|Evaluation Scales|"PATHOS / PEACCE : hypersexuality diagnostic scale
~MINI : Mini-International Neuropsychiatric Interview (comorbid psychiatric disorder)
~PDQ-4+: Personality Diagnostic Questionnaire version 4
~AUDIT
~Life trajectory : THQ
~Cognitive function (MoCA, Stroop)
~ISDSS: and self report of sexual activity and desire
~BARS: Brief Adhesion Rating Scale (treatment observance)
~SF-36 scale : quality of life
~BDI-II : Beck Depression Inventory
~BSSI ; Beck suicidal Inventory
~Cognitive functioning evaluation : Molest and Rape Scale
~Empathy: EMPAT
~Evaluation of Cognitive functioning: denial evaluation and Mc Kibben minimization
~Baratt Impulsivity Scale
~CSBI
~Static 99 and Stable 2007"
15816105|NCT04316650|Other|osteodensitometry|Osteodensitometry
15816106|NCT04316650|Biological|blood samples|"Lipid profile (total cholesterol, triglycerides, HDL cholesterol)
~Liver function (ASAT, ALAT, total bilirubin, transferase gamma-glutamyl et alcalin phosphatases
~Kydney function
~Blood count
~Biological Measurements and Measurement of Systematic Plasma Testosterone and TeBG Levels in Sex Offenders check for pathology of the Gonadotropin Axis
~Biological Measurements of Plasma Prolactin level"
15816107|NCT04316650|Other|ECG|ECG (heart rate, search for cardiac conduction disorders or cardiac arrhythmias)
15816108|NCT04316650|Genetic|Blood and saliva samples|Blood and saliva samples
15816109|NCT04316637|Drug|Arimoclomol|Participants receive prescribed arimoclomol by oral administration
15816110|NCT04316624|Drug|C-CAR066|Single infusion of C-CAR066 at a target dose of 1.0-9.0x 10^6 CAR+T cells/kg. Divided into three dose levels: low (1.0-3.0×10^6 CAR+T cells/kg), medium (3.0-6.0×10^6 CAR+T cells/kg) and high (6.0-9.0×10^6 CAR+T cells/kg).
15816111|NCT04316611|Drug|Potassium chloride|Direct intravenous injection (IVD) 20 mmol potassium chloride
15816112|NCT04316598|Drug|Cannabis Sativa|"Subjects will receive a total of 4 inhaled doses of 20 mg of tetrahydrocannabinol (THC) in 3 days.
~Cannabis is provided as a medical grade cannabis flos (Cannabis sativa dried female flower) containing THC 22% and cannabidiol <1%, supplied by Bedrocan®.
~To avoid the respiratory disadvantages of smoking, a vaporization device (Mighty® Medic) will be used to inhale the drug. The prepared capsules will contain 90 mg of Cannabis flos, equivalent to 20 mg of THC."
15816113|NCT04316598|Drug|Cannabis placebo|"Subjects will receive a total of 4 inhaled doses of cannabis placebo (THC <0,2%) in 3 days.
~Placebo cannabis is provided as a medical grade cannabis flos (Cannabis sativa dried female flower) containing cannabinoids <0.2%. To avoid the respiratory disadvantages of smoking, a vaporization device (Mighty® Medic) will be used to inhale the drug. The prepared capsules will contain 90 mg of cannabis placebo."
15816114|NCT04316585|Drug|GSK2982772|GSK2982772 will be available as MR tablet at a unit dose strength of 480 mg.
15816115|NCT04316585|Drug|Placebo|GSK2982772 matching placebo tablets will be administered via the oral route.
15816116|NCT04316572|Behavioral|mental health specialist video consultation|"The consultations will be based on a psychodynamic understanding with a solution-oriented stance and will follow a manual:
~Session 1: Getting familiar with the telemental health setting, building a working alliance and deepening diagnostics.
~Session 2: Clarification of the task/objective, focus building, motivational interviewing if necessary.
~Session 3-4: Focused brief interventions e.g. psychoeducation, promotion of social resources, activation of health-promoting lifestyles (sleep hygiene, eating diary, relaxation etc.), work on personal problems and, if necessary, initiation of further specialised treatment.
~Session 5: Ending the intervention, stabilisation, subsequent treatment plan and communicating a case summary to the general practitioner"
15816120|NCT04316520|Dietary Supplement|Ketogenic diet|Ketogenic diet 2:1
15816121|NCT04316507|Procedure|Genetic Counselling and Testing|Oncologist-initiated brief genetic counselling and testing
15816122|NCT04316494|Drug|Hydroxychloroquine|"White, round, film-coated tablets marked 'HCQ' on one side and 200' on the other side.
~Excipients:
~Lactose monohydrate Maize Starch Magnesium Stearate Polyvidone Opadry OY-L-28900"
15816123|NCT04316494|Drug|Placebo|"Placebo to match Hydroxychloroquine.
~Excipients:
~Microcrystalline cellulose Lactose Magnesium Stearate"
15816124|NCT04316481|Device|AngelMed Guardian System|The AngelMed Guardian System detects potential ongoing ACS events, characterized by sustained ST segment changes, and alerts the patient to seek medical attention for those potential ACS events. The Guardian System is indicated as an adjunct to patient recognized symptoms.
15816224|NCT04315740|Other|Clean Air|Nothing but clean air
15816125|NCT04316455|Other|Integrative Yoga Therapy|Participants having an hour in-person weekly session with qualified yoga therapist for 6-weeks. At each session, the personalised yoga practices including straightening and relaxing posture of yoga, yoga breathing, Combinations of sound and imagery yoga practices were given and asked to continue practice at home during the week.
15816126|NCT04316442|Biological|STI-6129|Three cycles of intravenous infusion of STI-6129 will be given (one infusion every three weeks).
15816127|NCT04316429|Other|Egg included vegan phase|: Participants will meet with a registered dietitian and receive instructions to include 2 eggs per day for 6 weeks as part of their otherwise vegan diets. Participants will also receive instructions to preserve an isocaloric condition with the addition of 2 eggs in their diets. Counseling of the study participants will be based on the U.S. Department of Agriculture (USDA) healthy vegetarian meal plans, with modifications to exclude dairy products. [21] Additional resources (e.g., educational materials, recipes, etc.) for adopting and maintaining a vegan diet (with the exception of including eggs) will also be provided.
15816128|NCT04316429|Other|Vegan Phase|The participants will consume a vegan diet for 6 weeks. The study dietitian will provide counseling and sample meal plans based on the USDA healthy vegetarian dietary pattern, with modifications to exclude eggs and dairy products. Additional resources (e.g., educational materials, recipes, etc.) for adopting and maintaining a vegan diet will also be provided.
15816129|NCT04316416|Procedure|T7 Level Erector Spinae Plane Block|"ESP block is planned after the completion of surgery and before the extubation. Its application will be planned from the T7 level bilaterally when the patients are turned to the right lateral position. A linear ultrasound probe will be placed in the longitudinal parasagittal orientation 3 cm to lateral of T7 spinous process.
~After imaging of erector spina musceles and transvers process of 7 th trorocal vertebrae, an ultrasound-guided local anaesthetic mixture ( 0.5% bupivacaine 15 cc + 2% lidocaine 5 cc) will be applied to the region between spinae muscles and transverse process using a needle of 22 gauge & 8cm directed from cranial to caudal.
~After application of the same procedure to the other side, the patients will be woken-up and patient-controlled analgesia consisting of intravenous morphine will be planned for all of them.
~Additionally, at postoperative 1.,4.,8.,12.,24. hours, NRS scales and morphine consumption will be recorded."
15816130|NCT04316416|Procedure|T9 Level Erector Spinae Plane Block|"ESP block is planned after the completion of surgery and before the extubation. Its application will be planned from the T9 level bilaterally when the patients are turned to the right lateral position. A linear ultrasound probe will be placed in the longitudinal parasagittal orientation 3 cm to lateral of T9 spinous process.
~After imaging of erector spina musceles and transvers process of 9 th trorocal vertebrae, an ultrasound-guided local anaesthetic mixture ( 0.5% bupivacaine 15 cc + 2% lidocaine 5 cc) will be applied to the region between spinae muscles and transverse process using a needle of 22 gauge & 8cm directed from cranial to caudal.
~After application of the same procedure to the other side, the patients will be woken-up and patient-controlled analgesia consisting of intravenous morphine will be planned for all of them.
~Additionally, at postoperative 1.,4.,8.,12.,24. hours, NRS scales and morphine consumption will be recorded."
15816131|NCT04316416|Drug|control group|24 hours morphine consumption will be recorded using the patient controlled analgesia device with intravenous morphine.
15816132|NCT04316403|Procedure|Er:YAG laser|This application was made before the onset of canine retraction in one side of the mouth
15816133|NCT04316390|Dietary Supplement|Control|study drink (two weeks)
15816134|NCT04316390|Dietary Supplement|Hesperidin|study drink + Hesperidin 600 mg (two weeks)
15816135|NCT04316390|Dietary Supplement|Vitamin C|study drink + Vitamin C 250 mg (two weeks)
15816136|NCT04316390|Dietary Supplement|Hesperidin + Vitamin C|study drink + Hesperidin 600 mg + Vitamin C 250 mg (two weeks)
15816137|NCT04316377|Drug|Hydroxychloroquine Sulfate|400 mg hydroxychloroquine sulphate (equalling 310 mg base) twice daily for seven days
15816138|NCT04316364|Drug|SHR-1316|SHR-1316, an engineered anti-PD-L1 antibody will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle
15816139|NCT04316364|Drug|Paclitaxel (Albumin Bound)|Paclitaxel (Albumin Bound) will be administered intravenously on Day 1,8,15 of each 21-day cycle
15816140|NCT04316364|Drug|Carboplatin|Carboplatin will be administered intravenously on Day 1 of each 21-day cycle
15816141|NCT04316364|Drug|Placebo|Placebo, will be administered as intravenous (IV) infusion on Day 1 of each 21-day cycle
15816142|NCT04316351|Drug|Toripalimab + Pemetrexed + Anlotinib|"Toripalimab 240 mg iv d1 + anlotinib 12mg po d1-d14 + pemetrexed 500mg / m2 d1 Q3W for 4 cycles, followed by Toripalimab 240mg iv d1 + anlotinib 12mg po d1 + pemetrexed 500mg / m2 d1 Q3W for another 31 cycles (up to a total of 35 cycles).
~If there is no disease progression, patients will receive anlotinib po 12mg d1-d14 + pemetrexed 500mg / m2 d1, Q3W for maintenance therapy until PD per RECIST v1.1 or loss of clinical benefit."
15816143|NCT04316338|Device|Intermittent theta-burst stimulation (iTBS)|Non-invasive brain stimulation technique
15816144|NCT04316325|Drug|Medical abortion|Trained abortion providers will counsel participants about medical abortion via videoconference or telephone, the abortion medications will be sent to the participants via mail or will be accessed at a pharmacy, the provider will follow up one week later with the participants to assess outcomes, and four weeks later the participant will take a pregnancy test to confirm completion of the abortion
15816145|NCT04316312|Device|Threshold inspiratory muscle trainer|Threshold inspiratory muscle trainer will be set between 15% to 30% of maximal inspiratory pressure.
15816146|NCT04316286|Procedure|Tele-multidisciplinary care|Scheduled televisit by sleep medicine specialists, endocrinologists, legal-medicine specialists
15816147|NCT04316286|Other|Standard care|Scheduled in-office visit by sleep medicine specialists, endocrinologists, legal-medicine specialists
15816148|NCT04316273|Other|colonic surgery|resection of duplicated colon
15816149|NCT04316260|Behavioral|Smoking cessation e-visit|electronic visits (e-visits) for smoking cessation
15816150|NCT04316260|Behavioral|Treatment As Usual|Information about the state quitline and about the importance of quitting smoking and a recommendation to contact one's PCP to schedule a medical visit to discuss quitting smoking
15816151|NCT04316234|Other|Passive vape|On days with passive vape, 2-3 vapers in an adjacent chamber were vaping by turn, and vape was passed on to the exposure chamber continuously .
15816152|NCT04316221|Dietary Supplement|Eggs plus standard of care|Eggs will be secured locally and delivered to families weekly.
15816326|NCT04314973|Other|Walking exercises|Walking exercises without wearing the robotic device.
15816154|NCT04316208|Procedure|PEEP variations|Patients will be ventilated with a PEEP of 5 cmH2O during induction of anesthesia. After craniotomy, the PEEP will be reduced to 0 cmH2O for 5 minutes and data will be collected at the end of 5 minutes. Next, PEEP will be increased to 5 cmH2O for 5 minutes and data will be collected at the end of 5 minutes. Finally, PEEP will be increased to 10 cmH2O for 5 minutes and data will be collected at the end of 5 minutes.
15816155|NCT04316195|Diagnostic Test|Assessment of the bulbocavernosus reflex|"According to the International Standards for Neurological Classification of Spinal Cord : The standard examination consists of the contraction of the bulbocavernous muscle following stimulation of the glans of the penis in men and of the clitoris in women.
~By electromyography: The electromyography consists to stimulate the bulbocavernosus reflex with a bipolar probe apply on the glans for men, and on the clitoris in women. A surface electrode will be positioned on the right or left bulbocavernous muscle at the base of the penis (or vagina) and the anus for recording. The bulbocavernous reflex will be obtained by stimulation at a frequency of 1.5Hz and an amplitude of 14 to 47 mA."
15816156|NCT04316182|Drug|Cabozantinib|Cabozantinib 60 mg/day. Cabozantinib dose will be modified upon development of adverse events.
15816164|NCT04316156|Device|Uincare Homeplus|Interactive digital healthcare system
15816165|NCT04316156|Other|Brochure|Brochure
15816166|NCT04316143|Drug|Zamicastat|Tablets for oral administration under fed conditions containing 100 mg of zamicastat (BIA 5-1058)
15816167|NCT04316130|Device|Uincare Homeplus|Interactive digital healthcare system
15816168|NCT04316130|Other|Brochure|Brochure
15816172|NCT04316104|Behavioral|CuidTXT|Culturally tailored text messages including dementia education, problem-solving skills training, social network support, care management and referral to community resources.
15816173|NCT04316091|Drug|neoadjuvant chemotherapy+SPIONs/SMF|Intratumoral injection of SPIONs, followed by SMF, combined with conventional neoadjuvant chemotherapy
15816174|NCT04316091|Drug|neoadjuvant chemotherapy|Conventional neoadjuvant chemotherapy only
15816175|NCT04316078|Other|patient engagement platform|"Allows patients to receive the action plan as educational videos on demand.
~Allows patients to report side effects and quality of life via questionnaires and receive immediate targeted education based on the predefined action plan."
15816176|NCT04316065|Drug|YHP1906|YHP1906 Tab. 5 mg
15816177|NCT04316065|Drug|YHR1902|Comparator. YHR1902 Tab. 5 mg
15816178|NCT04316052|Other|Aerobic training|After the baseline assessment, Following randomization into the exercise group, participants will undergo an exercise program orientation, which will be conducted individually.At the visit, participants will be first instructed in the use of the treadmill, which included heart rate assessment capability. Walking intensity and duration prescriptions will be accordance with recommendations of the American College of Sports Medicine. Participants will be instructed to walk for 45 minutes, including a 5-minute warm-up and 5 min cool-down, at 50% to 80% of their age-predicted maximum heart rate.Over the course of 4 months, each patient will complete 48 sessions. The morning after the 24th and 48nd sessions of aerobic physical exercise, each participant will be assessed completely
15816179|NCT04316052|Other|strength training|After the baseline assessment, participants will undergo exercise program orientation, which will be conducted individually. Participants will be instructed to perform 45 min session, two sets of 8 to 12 repetitions of each exercise (2 second hold each up and down hold) for the first 2 weeks to provide an introductory period. In the first session, muscular strength will be assessed using a standardized 10-repetition maximum approach, from which one repetition maximum (1-RM) will be estimated. The exercise prescription for strength training will be made at approximately 50% of the estimated 1-RM.The strength training activities included horizontal leg press, leg extension, leg curl, hip adduction, hip abduction, and seated rotary calf press.
15816180|NCT04316039|Drug|Temozolomide|Concurrent chemotherapy is to receive oral temozolomide, 75 mg/m2 per day, during radiation therapy. Adjuvant chemotherapy will be treated with six cycles of temozolomide, 150 to 200 mg/m2 per day for five consecutive days, repeated every 4 weeks. There is a 28-day break during radiotherapy and adjuvant temozolomide.
15816181|NCT04316039|Radiation|intensity modulated radiation therapy|The radiation dose is 50-54 Gy given in 25-30 fractions (1.8-2.0 Gy once daily, 5 days per week).
15816182|NCT04316026|Device|shock wave therapy|Shockwave therapy is a non-invasive treatment creating a series of low energy acoustic wave pulsations that are directly applied through the skin via a gel medium
15816183|NCT04316013|Drug|Sevoflurane|Inhaled anaesthetic used for maintenance of anaesthesia, dosed as per standard practice
15816184|NCT04316013|Drug|Propofol|Intravenous anaesthetic used for induction and maintenance of anaesthesia
15816185|NCT04316013|Drug|Lidocaine Iv|1.5mg/kg loading dose over 20 minutes, followed by an infusion of 2mg/kg/hr up to 4 hours and 1.5mg/kg/hour thereafter. Bolus and maintenance dosages of lidocaine will be per adjusted body weight (aBW), to a maximum of 100 kg, actual body weight to be used in patients less than 60kg.
15816186|NCT04316013|Other|Placebo|Normal saline
15816187|NCT04316000|Other|Initial Anxiety and Fear of Cancer Test|Answer to Hospital Anxiety and Depression Scale (HADS), Cancer Worry Scale (CWS) and European Five-Dimension Quality of Live test (EuroQol-5D) before the initial endoscopic procedure.
15816188|NCT04316000|Procedure|Endoscopic band ligation without resection of the subpetihelial tumour.|Correct application of the elastic band in the subepithelial tumor, achieving its removal by self-amputation in the 4-6 weeks endoscopic ultrasonography (EUS) control.
15816221|NCT04315753|Other|LDCT (Low Dose CT)|validate the role of non-invasive molecular and cellular biomarkers and combined radiomic signature, as complementary tools to assist early detection of lung cancer by LDCT using bioinformatic techniques for the integration of the results
15816189|NCT04316000|Other|1-2 Months Anxiety and Fear of Cancer Test|Answer to Hospital Anxiety and Depression Scale (HADS), Cancer Worry Scale (CWS) and European Five-Dimension Quality of Live test (EuroQol-5D) after 1-2 months of the initial endoscopic procedure, knowing whether the tumor has either been removed or not, is a benign entity or has not been observed.
15816190|NCT04316000|Other|1 Year Anxiety and Fear of Cancer Test|Answer to Hospital Anxiety and Depression Scale (HADS), Cancer Worry Scale (CWS) and European Five-Dimension Quality of Live test (EuroQol-5D) after 1 year of the initial endoscopic procedure, knowing whether the tumor has either been removed or not.
15816191|NCT04315987|Biological|NestaCell®|A dose of 2x10^7 cells (20 million cells) will be administered IV on days 1, 3, 5 and 7 in all subjects.
15816192|NCT04315987|Biological|Placebo|Matching Placebo will be administered IV on days 1, 3, 5 and 7 in all subjects.
15816193|NCT04315974|Drug|Rivaroxaban|Rivaroxaban therapy for at least 4 weeks.
15816194|NCT04315974|Procedure|Catheter ablation|Radiofrequency catheter ablation or cryoballoon ablation.
15816195|NCT04315961|Drug|Blinded drug dose conditions|Capsules will contain commonly prescribed or over-the-counter drugs or placebo. Capsules in this study may contain sedatives, muscle relaxants, or anti-anxiety medications, stimulant drugs/weight loss medications, or antihistamines which must remain blinded for the purposes of this study.
15816196|NCT04315948|Drug|Remdesivir|The lyophilized formulation of Remdesivir is a preservative-free, white to off-white or yellow, lyophilized solid containing 100 mg of Remdesivir to be reconstituted with 19 mL of sterile water for injection and diluted into IV infusion fluids prior to IV infusion. Following reconstitution, each vial contains a 5 mg/mL Remdesivir concentrated solution with sufficient volume to allow withdrawal of 20 mL (100 mg of remdesivir). It is supplied as a sterile product in a single-use, 30 mL, Type 1 clear glass vial.
15816197|NCT04315948|Drug|Lopinavir/ritonavir|"The oral tablets of lopinavir/ritonavir contain 200 mg lopinavir, 50 mg ritonavir. They have a yellow colour, film-coated, ovaloid shape debossed with the a logo and the code KA. The oral solution for patients who cannot swallow is a light yellow to orange colored liquid containing 400 mg lopinavir and 100 mg ritonavir per 5 mL (80 mg lopinavir and 20 mg ritonavir per mL)."
15816198|NCT04315948|Drug|Interferon Beta-1A|IFN-ß-1a is supplied as a sterile solution containing no preservative available in a prefilled syringe. It will be provided as a single-dose prefilled graduated syringe with 44 µg per 0.5 mL. The liquid should be clear to slightly yellow. Do not use if the liquid is cloudy, discolored or contains particles. Use a different syringe.
15816199|NCT04315948|Drug|Hydroxychloroquine|Hydroxychloroquine is supplied as film-coated 200 mg tablets. Hydroxychloroquine sulfate tablets are presented as white or whitish, peanut-shaped, oblong or round film-coated tablets containing 200 mg of hydroxychloroquine sulfate (equivalent to 155 mg base).
15816200|NCT04315948|Other|Standard of care|Standard of care
15816201|NCT04315948|Drug|AZD7442|AZD7442 will be supplied as separate vials of AZD8895 and AZD1061 containing 150 mg colorless to slightly yellow, clear to opalescent solutions for injection.
15816202|NCT04315948|Other|Placebo|Since April, 2021, the placebo will be a 0.9% (w/v) NaCl solution for infusion also called saline. The placebo will be supplied as a single 10-mL, clear and colorless vial.
15816203|NCT04315935|Drug|Butorphanol and Propofol|The two groups were given propofol for sedation, BG for butorphanol for analgesia and FG for fentanyl for analgesia
15816204|NCT04315935|Drug|Fentanyl and Propofol|Fentanyl (0.7-10 μ g / kg / h) analgesia and Propofol (1-4 mg / kg / h) sedation
15816205|NCT04315922|Diagnostic Test|Microbiome and Plasma Characterisation|Flow Cytometry, Mass-Spectometry, Shotgun-Sequencing
15816206|NCT04315909|Drug|PRP-Fibrin Glue|Platelet-Rich Plasma-Fibrin Glue
15816207|NCT04315909|Dietary Supplement|Vitamin E and C|Vitamin E and vitamin C
15816208|NCT04315909|Other|Placebo|Placebo
15816209|NCT04315896|Drug|Hydroxychloroquine|hydroxychloroquine 400mg day for 10 days
15816210|NCT04315896|Drug|Placebo oral tablet|Placebo oral tablet
15816211|NCT04315883|Behavioral|Quality of Life Assessment|"Evaluation of change of HRQOL survey responses will be performed:
~at baseline (time of treatment) and
~1 month post treatment
~6 months post treatment
~12 months post treatment
~5 years post-treatment
~The HRQOL will be done by phone, mail or email. Responses will be captured and entered into a REDCAP database"
15816212|NCT04315883|Radiation|Transarterial Radioembolization|"Deliver catheter directed yttrium-90 directly to liver tumors and assess -Progression Free Survival - Local and Metastatic
~Local Tumor Response by calculating the decreases in tumor size and enhancement after treatment. This will be assessed by modified Response Evaluation Criteria for Solid Tumors (mRECIST).
~Resection Rate following treatment
~Transplant Rate following treatment
~Histologic Response by assessing tumor histopathology in patients who undergo tumor resection or liver transplant
~Biologic Response by monitoring serum tumor markers (e.g. alphafetoprotein-AFP) in AFP secreting tumors
~Review of clinical course post-treatment-rehospitalization rate"
15816213|NCT04315870|Other|pregnant women with laboratory-confirmed 2019-n-CoV|Clinical records and compiled data of all consecutive hospitalized and outpatient pregnant women with laboratory-confirmed 2019-n-CoV were included in a merged database
15816214|NCT04315857|Other|interstitial glycaemia|Continuous measurement of interstitial blood glucose during the first 15 days of the first two chemotherapy courses.
15816215|NCT04315844|Device|Ewata balloon guiding|The balloon guide catheter is coaxial cavity and reinforced braided catheter with varying stiffness echelon.The distal end is marked by an impermeable ray, the proximal end has a bifurcated ruhr interface, and the end is embedded with a compliance balloon.The product label indicates the size of the balloon guide catheter and the maximum volume of the balloon.
15816216|NCT04315831|Drug|Transdermal Buprenorphine|Intervention will be applied for patients with moderate to severe cancer pain
15816217|NCT04315805|Other|Integrative Yoga Therapy|Yoga therapy will be based on personalised care consisting of Yoga relaxing posture, strengthening exercise, Yoga breathing, meditative psychotherapy, sound and imagery yoga practices, relaxation, yoga diet and life style management.
15816218|NCT04315792|Drug|Endoxifen|Administration of Endoxifen for 3 weeks
15816219|NCT04315792|Drug|Placebo oral tablet|Administration of Placebo for 3 weeks
15816220|NCT04315779|Procedure|Salpingectomy|Patients will undergo removal of the affected tube
15816222|NCT04315740|Other|Particles from candles|Generating fine and ultrafine particles from lit candles
15817143|NCT04308434|Other|CSD190601-23|Flavor variant CSD190601-23 of a 3.0% nicotine ENDS product
15816225|NCT04315727|Genetic|WGS Diagnostic Blood take for genetic diagnostic.|Blood sampling, shot clinical characterization, WGS based trio sequencing, NGS analysis and other omics analysis (transcriptomics, proteomics, metabolomics), functional cell biology studies (for example in fibroblast cultures), RNA Sequencing (RNA-seq).
15816226|NCT04315727|Genetic|Hair collection|Hair including root will be collected from the scalp (~15-20) and transferred to cultivation medium for the organoid cultivation
15816227|NCT04315714|Other|Yoga Program|Six-week, twice weekly, 60-minute private yoga program (delivered online/virtually via Zoom).
15816230|NCT04315688|Drug|insulin degludec|Treatment with Tresiba® with or without anti-diabetes medication (as per local label), as prescribed by the participant's physician. The study population will include adult patients with type 2 diabetes, both insulin naïve and previously insulin treated, for whom the treating physician has decided to initiate treatment with Tresiba®, independent of the decision to include the patient in the study.
15816231|NCT04315675|Behavioral|Guided Imagery Intervention|The participant listens to a selected Guided Imagery for 21 consecutive days.
15816232|NCT04315675|Behavioral|Cognitive Power Intervention|The participant develops a plan to achieve healthy outcomes and reviews plan for 21 consecutive days.
15816233|NCT04315675|Behavioral|Combined Guided Imagery and Cognitive Power Intervention|The participant completes 21 days of selected Guided Imagery in combination with the development of a plan to achieve healthy outcomes and reviews the plan for 21 days.
15816234|NCT04315662|Other|Muscle power training with velocity loss (VL) of 10%|Subjects followed a muscle power training for 8 weeks (2 sessions per week on alternate days) using the leg extension exercise, with similar relative intensity (50% 1RM). Between weeks one and four two series will be performed per session. Then the number of series will increase to three per session. The inter-set recovery period will be always of 2-min. Velocity loss will be of 10% (VL10) in each set.
15816235|NCT04315662|Other|Muscle power training with velocity loss (VL) of 30%|Subjects followed a muscle power training for 8 weeks (2 sessions per week on alternate days) using the leg extension exercise, with similar relative intensity (50% 1RM). Between weeks one and four two series will be performed per session. Then the number of series will increase to three per session. The inter-set recovery period will be always of 2-min. Velocity loss will be of 30% (VL30) in each set.
15816236|NCT04315649|Other|3D movie viewing|3D movie viewing
15816237|NCT04315636|Drug|Surfactant nebulisation|200 mg/kg body weight nebulised surfactant (Poractant alfa, Chiesi Farmaceutici SpA, Parma, Italy) via a customised vibrating membrane nebuliser (eFlow neonatal nebuliser system, PARI Pharma, Starnberg).
15816238|NCT04315623|Procedure|Regional citrate anticoagulation CRRT|Regional citrate anticoagulation Sodium citrate (4%) infusion before the filter in order to maintain post-filter ionCa2+ level between 0.25 to 0.35 mmol/L. Calcium gluconate supplementary after the filter to maintain serum ionCa2+ level between 1.0 to 1.2 mmol/L.
15816239|NCT04315623|Procedure|No-anticoagulation CRRT|Patients accepted no-anticoagulation CRRT. Blood flow 200 ml/h. The replacement fluid was infused 50% predilution and 50% post-dilution.
15816240|NCT04315610|Other|Access to mobile phone application|Under the guidance of healthcare personnel at the Neonatal Intensive Care Department (NICD) at Oslo University Hospital (OUH), parents are trained to assess their infant's condition, regarding circulation, breathing, eating habits, well-being, and more. In addition, before discharge, a baseline assessment of the infant's condition is stored in the application. After discharge, assessments using the application are performed if necessary.
15816241|NCT04315610|Other|Treatment as usual|Active comparator group, based on traditional information and follow-up.
15816242|NCT04315597|Drug|Laif® 900, BAY98-7108|1 x daily, 1 tablet, 900 mg
15816243|NCT04315597|Drug|Placebo|1 x daily, 1 tablet, 900 mg
15816244|NCT04315584|Procedure|Positron Emission Tomography|Undergo PET/CT Scans
15816245|NCT04315584|Procedure|Computed Tomography|Undergo PET/CT Scans
15816246|NCT04315584|Procedure|Multiparametric Magnetic Resonance Imaging Scan|Undergo a multiparametric MRI scan
15816247|NCT04315584|Radiation|Fludeoxyglucose F-18|IV (intravenous) administration of radiotracer
15816248|NCT04315584|Radiation|fluorine F 18 fluorodopa|IV (intravenous) administration of radiotracer
15816249|NCT04315571|Device|Gore® Viatorr® Endoprosthesis with controlled expansion|TIPS (Transjugular Intrahepatic Portosystemic Shunt) is a minimally invasive procedure in which a new path is made through the liver to carry blood from the portal vein to the heart, thus helping to alleviate the problems associated with elevated portal vein pressure.
15816250|NCT04315571|Procedure|Large Volume Paracentesis with albumin infusion|For therapeutic (large-volume) paracentesis, a 14-gauge cannula attached to a vacuum aspiration system is used to collect up to 8 L of ascitic fluid. Concurrent infusion of IV albumin is recommended during large-volume paracentesis to help avoid significant intravascular volume shift and postprocedural hypotension.
15816251|NCT04315558|Drug|Revefenacin Inhalation Solution [Yupelri]|nebulized drug comparison
15816252|NCT04315558|Drug|Ipratropium Bromide|nebulized drug comparison
15816253|NCT04315545|Diagnostic Test|meal tolerance test|In addition to the standard oral glucose tolerance (which is normally performed between 24-28 weeks of pregnancy), is used to test the metabolic resilience capacity of glucose, we will provide our participants with a different diagnostic tool named 'meal tolerance test' in an earlier stage of pregnancy (12-16 weeks), mid pregnancy (24-28 weeks) and 3 months postpartum.
15816254|NCT04315532|Other|Non-surgical periodontal treatment|Non-surgical periodontal treatment was performed for pregnant and non-pregnant gingivitis patients. Gingival crevicular fluid (GCF) and saliva samples were taken from all patients baseline and after 8 weeks.
15816255|NCT04315532|Other|Saliva samples|Saliva samples were taken from patients for the evaluation of sex steroid and stress markers baseline and after 8 weeks.
15816256|NCT04315532|Other|GCF samples|GCF samples were taken from patients for the evaluation of stress markers baseline and after 8 weeks.
15816257|NCT04315519|Other|Exercise|Aerobic Exercise
15816258|NCT04315506|Behavioral|SGR|The SGR program will reduce smokeless tobacco use by 1/4 until you reach zero. The intent of this program is to reduce the number of times participants use smokeless tobacco down to zero. Participants will also receive text-based support messages.
15817144|NCT04308434|Other|CSD190601-24|Flavor variant CSD190601-24 of a 3.0% nicotine ENDS product
15816259|NCT04315506|Behavioral|Control|Participants will be sent the Enough Snuff cessation manual. One weeks after it is sent, participants will then receive text messages from the study team twice a week for five weeks.
15816260|NCT04315493|Drug|pyrotinib maleate fasted in P1, low-fat diet in P2|pyrotinib maleate administration in fasted condition in period 1, pyrotinib maleate administration after low-fat diet in period 2
15816261|NCT04315493|Drug|pyrotinib maleate low-fat diet in P1, fasted in P2|pyrotinib maleate administration after low-fat diet in period 1, pyrotinib maleate administration in fasted condition in period 2
15816262|NCT04315480|Drug|Tocilizumab|single intravenous administration 8mg/Kg
15816263|NCT04315467|Drug|SGM-101|A one-time infusion of SGM-101
15816264|NCT04315467|Device|Near infrared camera imaging system|Near infrared camera imaging system
15816265|NCT04315454|Drug|Levobupivacaine|A group of patients will receive 20 ml of normal saline into the interfascial plane between rhomboids major &erector spinae muscle bilaterally at level thoracic spine T7,10 ml each side, the other group of patients will receive 20 mg 0.25% Levobupivacaine bilaterally as above 10 mg each side.
15816266|NCT04315441|Diagnostic Test|STEPS and AUDIT questionnaires|assessment was done according to World Health Organization STEPS manual for surveillance of risk factors of Non-communicable chronic diseases; and the Alcohol Use Disorders Identification Test. Five cardiovascular risk factors were assessed, smoking, harmful alcohol consumption, obesity/overweight, hypertension and diabetes. Cardiovascular risk was considered high in subjects with three or more cardiovascular risk factors.
15816267|NCT04315428|Behavioral|swaddling|The two experimenters together evaluate the child's state of awakening throughout the experiment. If the child is considered by both experimenters to be too restless or too sleepy, the experiment is immediately stopped and postponed
15816268|NCT04315428|Behavioral|no swaddling|The two experimenters together evaluate the child's state of awakening throughout the experiment. If the child is considered by both experimenters to be too restless or too sleepy, the experiment is immediately stopped and postponed
15816269|NCT04315415|Device|Silk Voice|Silk Voice comprised of silk protein and cross-linked hyaluronic acid (HA)
15816270|NCT04315402|Other|prospective, descriptive study via survey|"Survey administered at check out.
~Patient's rate of follow-up data gathered via chart review."
15816271|NCT04315389|Device|(1) Mobile Assistant Balance Robot|MRBA: Robotic wheelchair with a planar compliant robotic arm to provide balance assistance to the user at the pelvis and hip, during sit to stand, standing and walking tasks in indoor and controlled outdoor level environments.
15816272|NCT04315389|Device|(2) Transfer Assistive Cobot|TAC: Intelligent powered wheelchair equipped with a robotic arm that is capable of lifting payload up to 110kg, and perform a totally dependent transfer in a semi- autonomous fashion
15816273|NCT04315376|Behavioral|Exercise-Diet Intervention|The participants who performed exercise-diet intervention performed an Astrand-rhyming test before and after the exercise program intervention. Participants followed a progressive exercise-program during four months according to initial physical fitness. The main exercises consisted of improving aerobic, speed and resistance performance. During all single sessions, breathlessness and fatigue were measured using 0 to10 Borg scale. A personal trainer certified by American College of Sports Medicine (ACSM) supervised three sessions per week, the other two unsupervised training days the subjects were given the detailed training program to do in house/park. And also, this group received a diet intervention that consisted of a 20 percentage reduction of total energy expenditure estimated by the Mifflin formula with a nutrients distribution as follows: 50% carbohydrates, 30% lipids, and 20% proteins.
15816274|NCT04315376|Behavioral|Diet Intervention|This group received a diet intervention that consisted of a 20 percentage reduction of total energy expenditure estimated by the Mifflin formula with a nutrients distribution as follows: 50% carbohydrates, 30% lipids, and 20% proteins.
15816275|NCT04315363|Behavioral|Motivational MRI and Behavioral Intervention|Motivational messaging delivered during a functional brain MRI scan and with daily messaging
15816276|NCT04315363|Behavioral|Control MRI and Behavioral Intervention|Control messaging delivered during a functional brain MRI scan and with daily messaging
15816277|NCT04315350|Drug|Curcumin Liposome|Curcumin is given together with prednisolone
15816278|NCT04315350|Drug|Prednisolone|Prednisolone is given together with curcumin-placebo
15816279|NCT04315350|Drug|Placebos|Prednisolone-placebo is given together with curcumin-placebo
15816280|NCT04315337|Behavioral|Virtual Kitchen Training|VR Training will include repeated practice of a single, everyday task in a non-immersive VR context (e.g., VR Breakfast) using a laptop with a touch-screen interface for four days over the course of one week.
15816281|NCT04315324|Drug|AKR1C3-activated Prodrug OBI-3424|Given IV
15816282|NCT04315311|Drug|CREON|Capsule: Oral
15816283|NCT04315298|Drug|Sarilumab|Single or multiple intravenous (IV) doses of sarilumab. Additional doses may be administered if the patient meets protocol defined criteria.
15816284|NCT04315298|Drug|Placebo|Single or multiple intravenous (IV) doses of placebo to match sarilumab administration
15816285|NCT04315285|Behavioral|Treadmill gait training with verbal instruction|Each participant will receive 12 treatment with special verbal instruction which depends on participant's group. Each training session will last 60 minutes, including 5 minutes of warm-up stretching exercise, 40 minutes of treadmill training, and 15 minutes of over-ground gait and balance training. Throughout the 40 minutes of treadmill walking, the participants will walk on the level of 0% slope with a body-weight support system (LikorallTM 200, Liko, Sweden) used to protect the participants from falling; no actual weight support of the body will be provided. The frequency of intervention will be 2-3 days a week, spread across 4-6 weeks. The intervention protocols will be the same for all groups except the instruction provided to the participants in each group.
15816286|NCT04315272|Drug|Azithromycin|Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.
15816287|NCT04315272|Drug|Placebo|Placebo
15816288|NCT04315259|Device|Diode laser|irrigation activated by diode laser versus soft tissue laser application therapy
15816292|NCT04315220|Other|Corestability training|"Level -1: Mat exercises
~Abdominal muscle contraction,bridging,cat stretch,single limb circle and superman.:
~Level- 2: Swiss Ball Exercises Abdominal contraction,bridging and squats."
15816293|NCT04315220|Other|No Intervention|No Intervention
15816294|NCT04315207|Behavioral|Telephone call|"All patients are informed that they will receive a telephone call between 08 AM and 5 PM on workdays, as soon as the results of invasive workup are available. This is expectedly 3 to 5 days after invasive workup. At the telephone call, patients are free to ask for a later call, to summon relatives, to turn on the loud speaker, and/or ask the physician to call one relative of choice to share the information.
~Regardless of group, all patients are informed on the possibility of malignancy at every patient-physician encounter."
15816295|NCT04315207|Behavioral|In-person meeting|"All patients are provided a written and verbal appointment date 5 workdays after invasive workup, and that they will receive a telephone call if 1) results are not available at the time of the meeting, and/or 2) if results need urgent action (such as small-cell lung cancer).
~At the in-person meeting, patients are free to invite family and relatives (up to 4 persons, restriction due to space available).
~Regardless of group, all patients are informed on the possibility of malignancy at every patient-physician encounter."
15816296|NCT04315194|Drug|clarithromycin-naproxen-oseltamivir|to compare the safety and efficacy of clarithromycin-naproxen-oseltamivir combination therapy to that of oseltamivir treatment alone for hospitalised paediatric influenza patients.
15816297|NCT04315181|Drug|Opioid Agonist|Active opioid agonist or placebo, administered orally
15816298|NCT04315181|Drug|Sedatives|Active sedative or placebo, administered orally
15816299|NCT04315168|Device|FRED and FRED JR|Intracranial aneurysm treatment
15816300|NCT04315155|Drug|Belinostat|"Doublet Regimen Dose levels for Part 1:
~Belinostat Dose Level 1 (starting dose) 500 mg/m2 Dose Level 2 750 mg/m2 Dose Level 3 1000 mg/m2"
15816301|NCT04315155|Drug|nivolumab|Doublet Regimen Dose levels for Part 1 Nivolumab Dose Level 1 (starting dose) 360 mg Dose Level 2 360 mg Dose Level 3 360 mg
15816302|NCT04315155|Drug|ipilimumab|Triplet and Doublet Regimen Dose Levels for Phase 2 Ipilimumab Doublet Dose n/a Triplet Dose 1 mg/kg
15816303|NCT04315155|Drug|nivolumab|Triplet and Doublet Regimen Dose Levels for Phase 2 Nivolumab Doublet Dose 360 mg IV Triplet Dose 3 mg/kg
15816304|NCT04315155|Drug|Belinostat|Triplet and Doublet Regimen Dose Levels for Phase 2 Belinostat Doublet Dose RP2D Triplet Dose RP2D
15816305|NCT04315142|Device|Experimental TTNS|30-minute TTNS intervention is performed 2 days a week during a treatment period of 6 weeks
15816306|NCT04315142|Device|Sham TTNS|30-minute sham intervention is performed 2 days a week during a treatment period of 6 weeks
15816307|NCT04315129|Diagnostic Test|Smart Catheter Biosensor|A novel biosensor in-built into the catheter drainage system that monitors the chemical composition of the urine, with the intention of providing early diagnosis of developing infection
15816308|NCT04315116|Drug|pyrotinib maleate|a single oral dose of pyrotinib maleate on day 1 & day10 .
15816309|NCT04315116|Drug|Loperamide|Loperamide 4 mg bid from day 7 to day 13
15816310|NCT04315103|Combination Product|a single intraarticular injection of HYAJOINT Plus (3 ml) followed by 3 ml PRP|All the injections were done by the same experienced physician using aseptic procedures.
15816311|NCT04315077|Dietary Supplement|Oceanix®|Ingredient contains highly active antioxidant enzymes, including superoxide dismutase (SOD), as well as essential fatty acids, vitamins, amino acids and minerals.
15816312|NCT04315077|Other|Resistance Training|5 days of supervised and programmed whole-body resistance training.
15816313|NCT04315064|Drug|Treatment with MTX110|"Patients will undergo surgery for maximum safe tumor resection with simultaneous placement of a ventricular access device (VAD) into the fourth ventricle or posterior fossa tumor resection cavity.The specific ventricular access device that will be placed is Medtronic Reference number 44102, Medtronic CSF-Ventricular Reservoir Side Inlet, 18 mm.If a patient already has a ventricular access device in place and additional tumor resection is not required, then that patient can proceed with intraventricular chemotherapy infusions after study enrollment. If the patient has metastatic disease in the brain and/or spine without resectable tumor in the posterior fossa, then only catheter and ventricular access device placement will be performed.Enrolled patients will receive 4 infusions per week of panobinostat (MTX110; 0.25 ml of 300 μM = 26.2 μg), per infusion into the ventricular access device for 6 consecutive weeks for a total of 24 infusions."
15816314|NCT04315051|Drug|Cohort 1 J. Lividum|Subject to apply DBI-001 Gel on each foot covering all web spaces, the plantar and lateral aspects, toes and toenails
15816315|NCT04315051|Other|Placebo Gel|Subject to apply Placebo Gel daily on each foot covering all web spaces, the plantar and lateral aspects, toes and toenails.
15816316|NCT04315038|Procedure|spinal anesthesia|Plan to enroll 200 health volunteers and 40 neurodegenerative diseases patients with received spinal anesthesia. Blood will be collected at time point of pre-anesthesia 10 minutes and CSF samples will be collected at time point during spinal anesthesia induction. Blood will be collected, drawn into EDTA-coated tube.
15816317|NCT04315025|Biological|Umbilical Cord Mesenchymal Stem Cell (UC-MSC)|Umbilical Cord Mesenchymal Stem Cell (UC-MSC) injected by peribulbar
15816318|NCT04315025|Biological|Conditioned Medium (CM)|Conditioned Medium (CM) injected by peribulbar
15816319|NCT04315012|Other|receive mobile app-based education|to receive mobile app-based education on quality of life of women diagnosed with breast cancer implementation of adjuvant endocrine hormonal therapy.
15816320|NCT04314999|Diagnostic Test|Examination of stool samples|Tests for diagnosis of parasitic diseases
15816321|NCT04314986|Drug|Cohort 1: AR882 or placebo|AR882 or matching placebo administered once daily for 10 days
15816322|NCT04314986|Drug|Cohort 2: AR882 or placebo|AR882 or matching placebo administered once daily for 10 days.
15816323|NCT04314986|Drug|Cohort 3: AR882 or placebo|AR882 or matching placebo administered once daily for 10 days
15816324|NCT04314986|Drug|Cohort 4: AR882 or placebo|AR882 or matching placebo administered once daily for 10 days
15816325|NCT04314973|Device|Active Pelvis Orthosis|Walking with the robotic device providing the assistive protocol.
15816327|NCT04314960|Device|Functional electrical stimulation device (NESS L300Plus, Bioness, Valencia, CA)|Functional electrical stimulation (FES) is the application of high-intensity intermittent electrical stimuli to generate muscle contractions that may bypass spinal and supraspinal inhibition, and which is coupled with a functional task such as gait. Gait training will be conducted on a treadmill.
15816328|NCT04314934|Drug|ANAVEX2-73|Oral capsules
15816329|NCT04314921|Other|Yoga trainings|10-week yoga sessions, 2 times per week, 90 min per session.
15816330|NCT04314908|Procedure|Apical enlargement|"The teeth in this group will be treated according to the guidelines for retreatment in single-session. The filling will remove and cavity will be opened. The working length will be measured using apex locator and the 0 point will be based on. After standard irrigation protocol, root canals will be obturated with gutta percha and root canal sealer. Coronal restoration will complete using composite and/or fully crown if necessary."
15816331|NCT04314908|Procedure|Apical enlargement + Sonic Activation Assisted Irrigation|"The teeth in this group will be treated according to the guidelines for retreatment in single-session. The filling will remove and cavity will open. The working length will be measured using apex locator and the 0 point will be based on. After standard irrigation protocol, sonic activation assisted irrigation will be applied to the root canals. Then the teeth were obturated with gutta percha and root canal sealer. Coronal restoration will complete using composite and/or fully crown if necessary."
15816332|NCT04314908|Procedure|Non Apical enlargement|"The teeth in this group will be treated according to the guidelines for retreatment in single-session. The filling will remove and cavity will open. The working length will be measured using apex locator and 1 mm shorter than the 0 point will be based on. After standard irrigation protocol, root canals will be obturated with gutta percha and root canal sealer. Coronal restoration will complete using composite and/or fully crown if necessary."
15816333|NCT04314908|Procedure|Non Apical enlargement + Sonic Activation Assisted Irrigation|"The teeth in this group will be treated according to the guidelines for retreatment in single-session. The filling will remove and cavity will open. The working length will be measured using apex locator and 1 mm shorter than the 0 point will be based on. After standard irrigation protocol, sonic activation assisted irrigation will be applied to the root canals. Then the teeth were obturated with gutta percha and root canal sealer. Coronal restoration will complete using composite and/or fully crown if necessary."
15816334|NCT04314895|Drug|NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension|NanoPac is manufactured using a Precipitation with Compressed Antisolvent (PCA) technique that employs supercritical carbon dioxide and acetone to generate paclitaxel nanoparticles within a well-characterized particle-size distribution. Following PCA, NanoPac is filled into a clear 60mL Type 1, USP, clear-glass vial (306 mg/vial) as a powder fill of nanoparticulate paclitaxel, closed with a bromobutyl rubber stopper and aluminum crimp seal, and sterilized by gamma irradiation. Prior to administration at the hospital/clinic, NanoPac will be reconstituted with 1% Polysorbate 80, NF in 0.9% Sodium Chloride for Injection, USP, to form a suspension. The suspension will be further diluted with 0.9% Sodium Chloride for Injection, USP to achieve the final clinical formulation.
15816335|NCT04314869|Procedure|Uterus transplantation|Patient will undergo surgery in order to transplant the graft (uterus). After that, a follow-up in order to detect early rejection. After 6 months, embryo transfer will be perfomed. Labour route will be C-Section. Two pregnancies are agreed, and after the second one, a hysterectomy will be performed in order to remove the graft.
15816336|NCT04314856|Drug|18F-FTC-146|18F-FTC-146 is a PET radiopharmaceutical that can be used to determine sigma-1 receptor density.
15816337|NCT04314843|Drug|Cyclophosphamide|Administered according to package insert
15816338|NCT04314843|Drug|Fludarabine|Administered according to package insert
15816339|NCT04314843|Biological|Lenzilumab|Administered as an intravenous (IV) infusion
15816340|NCT04314843|Biological|Axicabtagene Ciloleucel|A single infusion of chimeric antigen receptor (CAR) transduced autologous T cells administered intravenously.
15816341|NCT04314830|Device|Gait training with perturbations|Changes in speed of one of the belt of the split belt treadmill during swing phase
15816342|NCT04314830|Device|Gait training without perturbation|Walking on a treadmill with steady belt speed
15816343|NCT04314817|Drug|Any drug used to treat Covid-19|lopinavir/ritonavir, remdesivir, interferon beta-1a, chloroquine and/or azithromycin. This list may be amended at a further date.
15816344|NCT04314804|Combination Product|PPP001|1 pellet smoked up to 3 times a day with titanium pipe (280 mg dried cannabis pellet - 9% THC / 2% CBD per pellet)
15816345|NCT04314804|Combination Product|Placebo|1 pellet smoked up to 3 times a day with titanium pipe (280 mg dried cannabis pellet - 0% THC / 0.6% CBD per pellet)
15816346|NCT04314791|Device|Ultrasound evaluation, with grayscale and color Doppler imaging|In pregnant women with previous CS and anterior low-lying or placenta previa, the following three sonographic criteria were assessed: (i) the smallest myometrial thickness in the sagittal plane; (ii) presence of placental lacunae and its grade from 0-3; (iii) bridging vessels using color Doppler. The PAI score (up to 9) was calculated for every patient as described by Rac et al.2015.
15816347|NCT04314778|Behavioral|social incentive-based gamification|At the beginning of each week, starting from postoperative day 3, the participant receives 70 points (10 points for each day that week). If the participant does not meet their daily step goal, they lose 10 points from their balance. This leverages loss aversion, which has been demonstrated to motivate behavior change more effectively with losses than gains. At the end of each week if the participant has at least 40 points, they will move up a level (levels from lowest to highest: blue, bronze, silver, gold, platinum). If not, the participant will drop a level. All participants begin at the silver level. Each week, participants get a fresh set of 70 points. Participants will receive daily feedback for the step counts, and weekly feedback for their levels. Participants in the intervention arm will be asked to identify a family member or friend to be their support sponsor. A weekly report will be sent to this person with the participant's performance (points and level).
15816348|NCT04314765|Procedure|lower third molar extraction|the extraction is performed with one of the two type of flap based non randomization.
15816349|NCT04314739|Dietary Supplement|Resveratrol|Participants will consume one of the treatment types daily for a period of four weeks.
15816350|NCT04314739|Dietary Supplement|Placebo|Participants will consume one of the treatment types daily for a period of four weeks.
15816351|NCT04314726|Drug|Amelogenin|amelogenins applied on the distal surface of the lower second molar after adjacent third molar extraction
15816352|NCT04314726|Drug|Placebos|placebo applied on the distal surface of the lower second molar after adjacent third molar extraction
15816353|NCT04314713|Drug|Scopolamine Hydrobromide Trihydrate|Scopolamine Hydrobromide Trihydrate Intramuscular Injection
15816354|NCT04314687|Biological|Umbilical Cord Mesenchymal Stem Cells|The umbilical cord was removed from the donor and brought to cell culture facility immediately. Upon arrival, pre-sterility sample testing was performed to ensure the sample was free from contaminant. Culture processes were conducted in a laboratory room where high sterility and safety were guaranteed. Every batch of the cells was monitored by a series of quality control testing to assure the quality of the product.
15816355|NCT04314687|Biological|Conditioned Medium|Conditioned medium collected from umbilical cord mesenchymal stem cell (UC-MSC) cultured. Every batch of the conditioned medium was monitored by a series of quality control testing to assure the quality of the product.
15816356|NCT04314687|Other|Standard Therapy|Standard therapy for cerebral palsy such as physiotherapy
15816357|NCT04314674|Drug|%3 HS bolus|After head fixation %3 HS bolus 3 ml/kg will be administered
15816358|NCT04314674|Drug|%3 HS infusion 20 ml/h|After head fixation %3 HS 20 ml/h infusion will be administered
15816359|NCT04314674|Drug|20% mannitol|After head fixation %20 mannitol 0.6 ml/kg will be administered
15816360|NCT04314661|Biological|Mesenchymal Stem Cells with Arthoscopy|Arthroscopy treatment after that injection Allogeneic Umbilical Cord Mesenchymal Stem Cells 5 million cells in NaCL 5 cc, two weeks later injection with Conditioned Medium 2 cc/knee, four weeks later injection with Conditioned Medium 2 cc/knee. All injection via Intraarticular injection.
15816361|NCT04314661|Biological|Mesenchymal Stem Cells without Arthoscopy|Injection with Allogeneic Umbilical Cord Mesenchymal Stem Cells 5 million cells in NaCL 5 cc, two weeks later injection with Conditioned Medium Derived Umbilical Cord Mesenchymal Stem Cells 2 cc/knee, four weeks later injection with Conditioned Medium 2 cc/knee. All injection via Intraarticular injection.
15816362|NCT04314661|Biological|Conditioned Medium without Arthoscopy|Injection with Conditioned Medium Derived Umbilical Cord Mesenchymal Stem Cells 2 cc/knee, four weeks later injection with Conditioned Medium 2 cc/knee. All injection via Intraarticular injection.
15816363|NCT04314648|Behavioral|Substance Use Treatment and Recovery Team (START)|Embedding of a collaborative care team, called the Substance Use Treatment and Recovery Team (START), for inpatients with OAUDs within an existing hospital consultation liaison psychiatry service.
15816364|NCT04314635|Behavioral|Brief family engagement intervention for CHR|The individual sessions, done with the caregiver and the teen separately, include a review of symptoms and a qualitative interview exploring treatment priorities, attitudes, and perceived barriers. The first family session focuses on psychoeducation. The second family session focuses on motivational enhancement, to promote ongoing engagement in services after discharge, including outpatient treatment and case management through the CSC.
15816365|NCT04314635|Behavioral|Treatment as usual (TAU)|The TAU group will receive treatment as usual on the adolescent inpatient unit. This includes individual therapy, psychiatric care, skills groups, and family therapy meetings.
15816366|NCT04314622|Drug|Supaglutide|Administered SC
15816367|NCT04314622|Drug|Placebo|Administered SC
15816368|NCT04314609|Device|Ultrasonography, fluoroscopy|success rate of Ultrasound guided SIJ steroid injection confirmed by contrast spread in fluoroscopy
15816369|NCT04314596|Other|Cross Training Course|One day of a supervised, whole body, cross-training course that is meant to produce muscle damage and soreness.
15816370|NCT04314596|Dietary Supplement|Oceanix|Ingredient contains highly active antioxidant enzymes, including superoxide dismutase (SOD), as well as essential fatty acids, vitamins, amino acids and minerals.
15816371|NCT04314583|Behavioral|Attention Control|Participants in this group will be asked to recall 3 to 5 events from the prior day of the intervention and write, or if unable to write, speak about these events.
15816372|NCT04314583|Behavioral|Gratitude Journaling|The gratitude journaling intervention involves participants writing or speaking 3-5 things for which they are grateful and focusing on these attributes. Participants will do this weekly for 12 weeks.
15816373|NCT04314570|Procedure|Saphenous Nerve Block with Ropivacaine Treatment|Regional Anesthesia nerve blocks have become standard practice for several orthopedic surgeries for post-operative pain management, however concerns for compartment syndrome have prevented nerve blocks to become common practice for tibial plateau open reduction internal fixation pain management. Interestingly, saphenous nerve blocks do not cover the sciatic nerve, allowing for pain management while reducing concerns that it may possibly mask compartment syndrome. Patients will receive ropivacaine through the catheter from the start of the nerve block.
15816374|NCT04314570|Procedure|Saphenous Nerve Block with Saline Control|Regional Anesthesia nerve blocks have become standard practice for several orthopedic surgeries for post-operative pain management, however concerns for compartment syndrome have prevented nerve blocks to become common practice for tibial plateau open reduction internal fixation pain management. Interestingly, saphenous nerve blocks do not cover the sciatic nerve, allowing for pain management while reducing concerns that it may possibly mask compartment syndrome. Patients will receive a loading dose of Normal Saline through the catheter. After one hour, the patient will receive their Ropivacaine infusions as per standard protocol.
15816375|NCT04314557|Device|Renal denervation|Spyral device. Bilateral renal denervation.
15816376|NCT04314544|Drug|TILD|one 1 mL injection of study medication
15816377|NCT04314544|Drug|matching placebo injections|one 1 mL injection of placebo
15816378|NCT04314531|Drug|TILD|one 1 mL injection of study medication
15816379|NCT04314531|Drug|matching placebo injections|one 1 mL injection of placebo
15816380|NCT04314505|Drug|Opioid-Sparing Protocol|After a general anesthesia procedure was performed, an experienced anesthesiologist performed ultrasound guided adductor canal block procedures on both knees. In the opioid-sparing group, a dose of Parecoxib sodium 40 mg was administrated through intravenous route before the incision. After the surgery, Parecoxib sodium 40 mg was given intravenously every 12 hours for 4 more doses. Before the wound closure, the periarticular injection (each side 10 ml of 0.25% Bupivacaine) was done. The total dosage would be recorded in the device. All patients received oral paracetamol 500mg, 4 times a day and oral celecoxib 200mg, 2 times a day after surgery.
15816470|NCT04313725|Device|Tangible Boost|Patients will perform a monthly Tangible Boost treatment on their Hydra-PEG treated contact lenses.
15817145|NCT04308434|Other|CSD190601-25|Flavor variant CSD190601-25 of a 3.0% nicotine ENDS product
15816381|NCT04314505|Drug|Opioid-Based Patient Controlled Analgesia|After a general anesthesia procedure was performed, an experienced anesthesiologist performed ultrasound guided adductor canal block procedures on both knees. The patient was informed that the intravenous bolus of rescue morphine (4mg) was available every 4 hours if the pain was intolerable. In the PCA group, the device was applied before incision and the initial setting was 0.01mg/kg*hour, patient-controlled dose 2 mg, lock-out 5 minutes and limited 40mg in each 4 hours. After the surgery, the staff of PCA group would visit the patients and adjusted the dosage. The PCA was removed after 72 hours from the surgery. Before the wound closure, the periarticular injection (each side 10 ml of 0.25% Bupivacaine) was done. The total dosage would be recorded in the device. All patients received oral paracetamol 500mg, 4 times a day and oral celecoxib 200mg, 2 times a day after surgery.
15816382|NCT04314492|Procedure|Tonsillectomy|Intracapsular removal of tonsillar tissue (>90%) with coblation
15816383|NCT04314479|Behavioral|Symptom Assessment and Health Coaching|The intervention condition will involve weekly symptom assessment and health coaching to manage symptoms and to meet the ACS cancer prevention guidelines provided over the telephone by trained health coaches. Participants will be completing the same forms/assessments throughout the study. The content will be built around the Symptom Management Toolkit. The coaching will be dictated by the symptoms the survivor or the support person is experiencing the week of the intervention call. All calls begin with the symptom assessments, only the intervention arm includes intervention coaching that focuses on physical activity, stress management, or eating a healthy diet to improve adherence to the ACS guidelines for cancer prevention. We anticipate coaching sessions will last approximately 20 - 45 minutes.
15816384|NCT04314453|Other|percutaneous endoscopic lumbar discectomy|Resection of the hypertrophied faceted joints, osteophyte formation and ligamentum flavum (LF) hypertrophy, with or without disc protrusion for degenerative spinal stenosis.
15816385|NCT04314440|Behavioral|Music therapy|"An accredited music therapist will deliver 15-20 minutes of music therapy every day, 4-5 days in week one and remaining in week two to all MT participants. All participants in music therapy group will get a total of nine sessions. The lullaby twinkle twinkle little star will be sung for ~5 minutes, followed by the same songs played on acoustic guitar for ~5 minutes and another ~5 minutes of the same song sung in voice. This protocol will be followed in all 9 sessions for all infants in the experimental arm. The sound levels will be maintained at 55-65 decibels (dB) using appropriate meters. If MT is interrupted within 10 minutes then a make-up session will be delivered, assuming no discharge. In case of missed sessions and interrupted session infants will receive a maximum of 12 session."
15816386|NCT04314427|Procedure|Roux-en-Y gastric bypass|
15816387|NCT04314427|Procedure|Sleeve gastrectomy|
15816390|NCT04314401|Procedure|Biospecimen Collection|Undergo collection of blood, tissue, bone marrow, and cerebral spinal fluid samples
15816391|NCT04314401|Other|Medical Chart Review|Medical charts are reviewed and data is collected
15816392|NCT04314388|Other|Intervention: Outdoor Walking Rehabilitation Programme|Participants in the intervention group will take part in an instructor led outdoor walking rehabilitation programme which will last for 3 months. Alongside this participants will also be asked to complete a home exercise programme.
15816393|NCT04314388|Other|Control: The light Stretches Programme|Participants in the control group will be asked to keep to their normal activities of daily living, and given 10 targeted active stretches of the upper and lower body.
15816394|NCT04314375|Drug|Low Dose Budesonide|3 milligrams once daily for ages 5 to 11 years 11 months. 6 milligrams once daily for ages 12 to 17 years.
15816395|NCT04314375|Drug|High Dose Budesonide|6 milligrams once daily for ages 5 to 11 years 11 months. 9 milligrams once daily for ages 12 to 17 years.
15816396|NCT04314375|Drug|Placebo|Matching placebo once daily.
15816397|NCT04314362|Drug|AZR-MD-001 ointment/semi-solid drug|AZR-MD-001 (1.0%) and suitable excipient
15816398|NCT04314336|Drug|Public procurement|Cost minimisation study through public procurement
15816399|NCT04314336|Drug|Drug and Therapeutics Committee|Cost minimisation analysis of results of the drug and therapeutics committee before and after clinical pharmacist involvement
15816400|NCT04314310|Drug|Tenoxicam|nonsteroidal anti-inflammatory drug (NSAID)
15816401|NCT04314310|Drug|Placebo|equal volume of normal saline
15816402|NCT04314297|Drug|Anlotinib In Combination With Durvalumab|"At the end of chest radiotherapy (c2d1), the simultaneous administration of androtinib hydrochloride capsule and PD-1 / L1 inhibitor was started. L
~Arotinib hydrochloride capsule, 12 mg, Po, QD, was taken orally for two weeks, one week, three weeks as a cycle, completed in the first 14 days until the disease progress;
~Durvalumab injection, 1500mg, IV, once every three weeks, completed on the first day until the disease progresses.
~Tetraprizumab injection, 240mg, IV, once every three weeks, completed on the first day until the disease progresses.
~The choice of durvalumab / trepril mAb was at the discretion of the researchers."
15816403|NCT04314284|Behavioral|I Can PIC|-Online decision tool that explains health insurance terms and health insurance terms, provides tips on lowering health care costs, advises patient to discuss costs with provider and insurance, and provides financial resources for patient.
15816404|NCT04314284|Other|Provider survey|-Questions about discussing cancer care costs with patients and demographic questions about the provider
15816405|NCT04314284|Other|Historical control survey|-31 questions including overall experience with cancer care provider, previous discussions with care team regarding health care costs, preferences for discussing health care costs with physician, confidence level on discussing health care costs with physician, feelings about current financial situation, delays or avoidance of medical care in the past 12 months, confidence in health care choices and health insurance choices, current health conditions, and demographic data.
15816471|NCT04313725|Other|Placebo|Patients will perform a monthly placebo (saline) treatment on their Hydra-PEG treated contact lenses.
15817146|NCT04308434|Other|CSD190601-26|Flavor variant CSD190601-26 of a 3.0% nicotine ENDS product
15816406|NCT04314284|Other|Post-intervention survey (I Can PIC participants)|-31 questions including overall experience with cancer care provider, previous discussions with care team regarding health care costs, preferences for discussing health care costs with physician, confidence level on discussing health care costs with physician, feelings about current financial situation, delays or avoidance of medical care in the past 12 months, confidence in health care choices and health insurance choices, current health conditions, and demographic data.
15816407|NCT04314284|Other|Follow-Up survey (I Can PIC participants)|-19 questions including overall experience with cancer care provider, discussion with care team regarding health care costs, preferences for discussing health care costs with physician, confidence level on discussing health care costs with physician, feelings about current financial situation, delays or avoidance of medical care in the past 12 months, and confidence in health care choices and health insurance choices.
15816408|NCT04314258|Dietary Supplement|Moringa oleifera tea|4 grams of Moringa oleifera tea twice daily
15816409|NCT04314245|Other|Active Comparator: Pathology|Routine treatment for bladder cancer, and surgical pathology for confirmation of patients with urothelial carcinoma.
15816410|NCT04314245|Other|Active Comparator: Clinical Diagnosis|Routine clinical diagnosis and treatment of benign disease of the urinary system
15816411|NCT04314245|Other|Active Comparator: Clinical diagnosis|Routine urine test and imaging diagnostic techniques, such as B-ultrasound.
15816412|NCT04314245|Other|Genetic test: AnchorDx's urine DNA methylation/somatic mutation profiling assay|A urine-based assay for the detection of urothelial carcinoma using urine DNA methylation/somatic mutation profiling analysis.
15816413|NCT04314219|Drug|Cyclophosphamide 50mg|Cyclophosphamide as GVHD prophylaxis will be on day +3 and day +5
15816414|NCT04314219|Drug|Methotrexate|Methotrexate as GVHD prophylaxis will be on day +1, day +3, and day +6
15816415|NCT04314206|Drug|VNRX-5024|"Part 1: one dose
~Part 2:
~Cohort 1: 10 doses (once a day for 10 days) Cohort 2: 19 doses (once every 12 hours [q12h] dosing for 9 days with a single morning dose on Day 10) Cohort 3: 28 doses (once every 8 hours [q8h] dosing for 9 days with a single morning dose on Day 10)"
15816416|NCT04314206|Drug|Placebo for VNRX-5024|"Part 1: one dose
~Part 2:
~Cohort 1: 10 doses (once a day for 10 days) Cohort 2: 19 doses (once every 12 hours [q12h] dosing for 9 days with a single morning dose on Day 10) Cohort 3: 28 doses (once every 8 hours [q8h] dosing for 9 days with a single morning dose on Day 10)"
15816417|NCT04314193|Drug|Methotrexate|Oral methotrexate (15 mg weekly to be increased to 25 mg weekly) for 24 weeks.
15816418|NCT04314193|Drug|Prednisolone|Oral prednisolone (start 40 mg daily, to be tapered to 10 mg daily) for 24 weeks.
15816419|NCT04314180|Device|Taking slit-lamp images|The participant only needs to take several slit-lamp images as usual.
15816420|NCT04314167|Drug|Lowering cholesterol concentrations by PCSK-9 inhibitor|Patients will receive the PCSK9-inhibitor Evolocumab as part of routine clinical management within the indication of this drug.
15816421|NCT04314154|Other|Monitoring PROM @ PREM data on participating patients|"125 patients (ages 18-55) admitted to SHALVATA mental health center and their clinicians will be recruited to participate in a prospective longitudinal assessment. Each will include PREMs, PROMs clinician rated outcomes and assessment of the degree to which clinical indicators (reflected processes of clinical guidelines) were carried out. The assessments will take place at admission, discharge and every 3 months for up for 9 months. The design is a repeated measures design with evaluating the interaction effect between assessed levels of indicators (between subject effect) and level of change in the PREMs, PROMs clinician along the research trajectory (within subject effect)."
15816422|NCT04314141|Procedure|Evaluation of surgical outcomes, quality of life and patient's satisfactions with phalloplasty|"Send a questionnaire to patients to collect informations about:
~Sexual quality of life before and after the surgery
~Satisfaction after surgery
~Data collection in medical file :
~Surgery outcomes
~Functional outcomes"
15816423|NCT04314128|Diagnostic Test|TOS and TCD|TOS: Transorbital sonography TCD: Transcranial Doppler
15816424|NCT04314115|Other|Mindfulness|Brief intervention in mindfulness, of individual type, of four sessions of sixty minutes per week, in addition to individual tasks, according to protocol of brief intervention in developed mindfulness.
15816425|NCT04314115|Other|Systemic therapy|Brief systemic therapy intervention, of four weekly sessions of sixty minutes, with individual tasks and assignments, according to the protocol designed.
15816426|NCT04314115|Other|Cognitive behavioral therapy and positive psychology|Brief intervention of traditional cognitive behavioral therapy with elements of positive psychology, of four weekly sessions of sixty minutes, with individual assignments and assignments, according to the protocol designed.
15816427|NCT04314102|Other|No intervention will be made.|No intervention will be made. Only checks will be made
15816428|NCT04314089|Drug|GT103|intravenously (dose depending)
15816429|NCT04314076|Other|Rythmic auditory stimulation|RAS, a Neurologic Music Therapy technique developed to utilize rhythm and timing cues to assist in improving the basic, intrinsic rhythmic movements of gait.
15816430|NCT04314076|Other|Gait Training|Continuous overground walking on a track for 30 minutes. Gait training will primarily consist of walking exercise under the supervision of an exercise physiologist.
15816431|NCT04314063|Other|nasal swap|nasal swap to detect prevalence of staph aureus in food handlers
15816432|NCT04314050|Drug|Tramadol|tramadol and paracetamol will perform
15816433|NCT04314050|Drug|Dexmedetomidine|dexmedetomidine and paracetamol will perform
15816434|NCT04314050|Other|control|paracetamol will perform
15816435|NCT04314037|Drug|Cesol (Test)|Participant will receive coated cesol tablet in sequence 1 (Day 1 and Day 15) and in sequence 2 (Day 8 and Day 22). A washout period of 7 days will be maintained between 4 treatment periods.
15816436|NCT04314037|Drug|Biltricide (Reference)|Participant will receive biltricide tablet in Sequence 1 (Day 8 and Day 22) and in sequence 2 (Day 1 and Day 15). A washout period of 7 days will be maintained between 4 treatment periods.
15816437|NCT04314024|Drug|Evobrutinib|Participants will receive single oral dose of evobrutinib either after an overnight fast of at least 10 hours (Treatment A and Treatment B), or under fed conditions that is within 30 minutes after start of high-fat meal (Treatment C) in period 1, 2 and 3.
15816438|NCT04314011|Biological|Human umbilical cord mesenchymal stem cells（HUC-MSCs）|Human umbilical cord mesenchymal stem cells（HUC-MSCs）
15816439|NCT04314011|Biological|Placebo|Placebo
15816440|NCT04313985|Device|Tennant Biomodulator-Pro™ Device|Tennant Biomodulator-Pro™ conductive electrode pads will be placed on both sides of the wound. The device will either deliver electrical stimulation or not depending on what treatment group the participant is in.
15816441|NCT04313972|Drug|low-dose naltrexone|2mg of low-dose naltrexone nightly for 2 weeks, then 4mg of low-dose naltrexone nightly for 4 weeks
15816442|NCT04313972|Drug|Placebo oral tablet|1 capsule nighty for 2 weeks, then 2 capsules nightly for 4 weeks
15816443|NCT04313959|Drug|Ropivacaine 0.2% Injectable Solution|Single-shot ultrasound-guided erector spine plane block of 0.2% ropivacaine
15816444|NCT04313959|Drug|Dexamethasone|Addiction of 4 mg/ml dexamethasone in 0.2% ropivacaine solution
15816445|NCT04313946|Diagnostic Test|Scanning Chest X-rays and performing AI algorithms on images|Chest X-Rays; AI CNNs; Results
15816446|NCT04313920|Other|Nutritional Supplement|50 g Carbohydrate
15816447|NCT04313907|Combination Product|low level laser therapy plus topical clonazepam|combination of treatment, low level laser therapy (15 joules, 6 sesions, 14 days) plus topical clonazepam (1 mg,3 times per day, 14 days)
15816448|NCT04313907|Drug|Sham laser plus topical clonazepam|Sham laser therapy (0 joules, 6 sesions, 14 days) plus topical clonazepam(1 mg,3 times per day, 14 days)
15816449|NCT04313907|Radiation|Active laser plus placebo of topical clonazepam|low level laser therapy (15 joules, 6 sesions, 14 days) plus placebo topical clonazepam(lactose,3 times per day, 14 days)
15816450|NCT04313894|Biological|Wharton Jelly Originated Mesencimal Stem Cell|In this study, the patient who has no systemic disease from Erciyes University, Obstetrics and Gynecology Department will be taken to the cord transport solution which will be medical waste after delivery. Samples for transport bacteriological tests from the transport solution to the laboratory shall be separated. They will be processed in a number of ways. The cells obtained will be administered intraarticularly at a dose of 1 x 100.000.000.
15816454|NCT04313868|Drug|GEN2 (HSV-Thymidine Kinase-m2 and hGM-CSF Genes)|GEN2 is an investigational drug combining cytotoxic and immunotherapy.
15816455|NCT04313855|Diagnostic Test|SMS in the early detection of postoperative neuropathic pain|"7 days after the intervention, the patient receives a standardized questionnaire by SMS, to determine whether the patient has pain at the operating site and whether this pain has the characteristics of neuropathic pain. After replying to the SMS, the patient will be contacted by phone to assess: the intensity of pain at the operating site using a numerical scale and the existence of neuropathic pain. Depending on the responses received by SMS and/or phone, a consultation appointment with an anesthesiologist specializing in pain may be offered within a maximum of 2 weeks.
~Ninety days after your surgery, the patient receives the same standardized questionnaire by SMS. The patient will be contacted by telephone, in order to assess the intensity of pain at the operating site and the existence of neuropathic pain using. If the patient has post-operative pain, a consultation appointment with an anesthesiologist specializing in pain will be offered to him within a maximum of 2 weeks."
15816456|NCT04313842|Device|AVATAMED|tumor specimen will be sent for in vitro drug screening experiment and the result will be analyzed by 'AVATAMED' to predict the clinical response
15816457|NCT04313829|Behavioral|Pharmacist Counseling Intervention|We used the counseling module (in the form of a guide book) for pharmacist-based counseling that had been validated regarding constructive content by an endocrinologist and a pharmacist expert in diabetes drug counseling. The module explained the T2DM causes and symptoms, the reasons for the importance of therapy, the non-pharmacological and pharmacological therapies available (drug names, strengths, indications, rules of use, side effects, interactions, and storage), the purpose of controlling blood sugar levels, medications that need to be avoided, and guidelines for missed doses. The pharmacists should explain all the content within the module in 15 minutes to each patient of the intervention group each month for 6 months. As an ethical consideration, the control group patients were given the same explanation module through pharmacist counseling after the study finished.
15816458|NCT04313816|Other|questionnaire|no intervention at all apart from filling a brief questionnaire
15816459|NCT04313803|Device|CGM|Dexcom CGM system
15816460|NCT04313790|Drug|Heparin Infusion|500 unit heparin infusion \ hour for DVT prophylaxis experimental group (n=50)
15816461|NCT04313790|Other|subcutaneous heparin|5000 unit subcutaneous heparin /8 hours control group n=(50)
15816462|NCT04313777|Behavioral|Cardiac rehabilitation|Four weeks of cardiac rehabilitation conducted in an outpatient care facility. Three times per week (80 minutes per day) cardiologically monitored aerobic training consisting of: 40 minutes of interval training on a cycloergometer and 40 minutes of general fitness exercises.
15816463|NCT04313777|Device|Virtual therapeutic support|8 sessions of VR therapy (each of them 20 minutes long). As a virtual reality source, VR Tier One device (Stolgraf®) were used. Thanks to using head mounted display and the phenomenon of total immersion VR therapy provides an intense visual, auditory and kinesthetic stimulation. It can have a calming and mood-improving effect or help the patients recognize their psychological resources and motivate to the rehabilitation process. In the virtual therapeutic garden there are a rich set of symbols and metaphors based on Ericksonian Psychotherapy approach.
15816464|NCT04313777|Behavioral|Schultz Autogenic Training|8 sessions of Schultz Autogenic Training (each of them 20 minutes long).
15816465|NCT04313764|Drug|Bupivacaine Hcl 0.25% ESP block|Ultrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine, per side
15816466|NCT04313764|Drug|Bupivacaine Hcl 0.25% infiltration|Wound infiltration with 20 ml %0.25 bupivacaine
15816467|NCT04313751|Behavioral|Education, Physical Activity, and Stress Management Program|Twelve weekly classes for one hour focused on CVD risk factor education using the Su Corazón Su Vida curriculum and coping skills training followed by a 45 minute exercise class and 15 minute stress management session. Then they will return for one hour for continued support, a forty-five minute exercise class, and fifteen minute stress management session.
15816468|NCT04313751|Other|Wait-list|The wait-list control group will receive 12 weekly one hour education and coping skills training sessions followed by a 45 minute exercise class and a 15 minute stress management session.
15816469|NCT04313738|Other|Assigned Interventions|Home visit, health education
15816473|NCT04313699|Drug|Antiretroviral treatment|The cohort will recruit HIV infected participants who are on antiretroviral treatment
15816474|NCT04313686|Behavioral|Mindfulness-based therapy|Based on randomization, those who first receive the mindfulness training program are the intervention group. Participants would meet weekly for 2-3-hour long sessions for six weeks at the patient's usual follow-up clinic.
15816475|NCT04313686|Behavioral|No-intervention|Participants who were randomized into this group would continue to receive their usual follow-up care at the usual neurology outpatient clinic.
15816476|NCT04313673|Diagnostic Test|second trimester ultrasonography|Patients undergoing routine antenatal screening between 18-24 weeks and measuring cervical length with transabdominal ultrasonography in the same session
15816477|NCT04313660|Drug|Anlotinib In Combination With PD-1/L1 Inhibitor|"At the end of chest radiotherapy (c2d1), the simultaneous administration of androtinib hydrochloride capsule and PD-1 / L1 inhibitor was started. L
~Arotinib hydrochloride capsule, 12 mg, Po, QD, was taken orally for two weeks, one week, three weeks as a cycle, completed in the first 14 days until the disease progress;
~Durvalumab injection, 1500mg, IV, once every three weeks, completed on the first day until the disease progresses.
~Tetraprizumab injection, 240mg, IV, once every three weeks, completed on the first day until the disease progresses.
~The choice of durvalumab / trepril mAb was at the discretion of the researchers."
15816478|NCT04313647|Biological|1X level of MSCs-Exo|Once aerosol inhalation of MSCs-derived exosomes (2.0*10^8 nano vesicles/3 ml)
15816479|NCT04313647|Biological|2X level of MSCs-Exo|Once aerosol inhalation of MSCs-derived exosomes (4.0*10^8 nano vesicles/3 ml)
15816480|NCT04313647|Biological|4X level of MSCs-Exo|Once aerosol inhalation of MSCs-derived exosomes (8.0*10^8 nano vesicles/3 ml)
15816481|NCT04313647|Biological|6X level of MSCs-Exo|Once aerosol inhalation of MSCs-derived exosomes (12.0*10^8 nano vesicles/3 ml)
15816482|NCT04313647|Biological|8X level of MSCs-Exo|Once aerosol inhalation of MSCs-derived exosomes (16.0*10^8 nano vesicles/3 ml)
15816483|NCT04313634|Drug|Dasatinib|Dasatinib will be supplied as 100 mg tablet white to off-white, biconvex, oval, film- coated
15816484|NCT04313634|Drug|Quercetin|Quercetin will be supplied as quercetin phytosome (sophora japonica concentrate (leaf) / phosphatidylcholine complex from Sunflower) 250 mg
15816485|NCT04313634|Drug|Fisetin|Fisetin will be supplied in 100 mg capsules to be administered orally
15816492|NCT04313595|Device|RespirHó|"The system is a wearable, unobtrusive inertial-sensor-based device for long-term breathing pattern monitoring, also during daily life activities. It consists of three IMU-sensor units (3-axis accelerometer, 3-axis gyroscope, 3-axis magnetometer), positioned respectively on the patient's abdomen and thorax, and on a body area integral with thorax but not affected by espiratory movements. The peripheral units, placed on thorax and abdomen are used to record orientation changes during respiratory movements. The third unit is a central reference unit (hereafter CRU) that receives data from the other two units, save them on an SD card and communicate via Bluetooth with a smartphone / tablet / PC. Moreover, this unit detects only non-respiratory movement, representing not only a pure source of noise that must be removed from the thoracic and bdominal signals, but also a pure source of additional information regarding the state of ctivity of the subject ."
15816493|NCT04313582|Behavioral|SmartPrompt smartphone application|The SmartPrompt is a smartphone application designed specifically for older adults with difficulties remembering to do daily tasks due to cognitive difficulties.
15816494|NCT04313569|Procedure|Arthroscopic menisctomy|Arthroscopic medial menisctomy
15816495|NCT04313556|Procedure|Lateral patellar release|Arthroscopic lateral patellar reticular release
15816496|NCT04313543|Dietary Supplement|Glucose and Longan syrup|Volunteers take 50 g of glucose in 250 ml of water in 5 minutes. Then, they take 50g of longan syrup in 250 ml of water in 5 minutes
15816497|NCT04313530|Device|Repetitive Transcranial Magnetic Stimulation|Transcranial magnetic stimulation (TMS) is a non-invasive method that uses electromagnetic induction to produce electric currents in the cortex that are strong enough to depolarise neurons sufficiently to trigger action potentials. It is an outpatient based procedure that when used in conjunction with a neuro-navigation system, specific cortical areas can be targeted for greater accuracy and efficacy. In clinical studies, TMS is delivered as trains of pulses (repetitive TMS, rTMS) to prolong its effects. While the exact mechanism of TMS treatment fatigue is unknown, it is thought to regulate the activity of the complex cortical and subcortical networks connectivity changes involved in the processing of fatigue signals.
15816498|NCT04313517|Other|Yoga|Each yoga session included warm-up practices (for the large joints, spine, and extremities), Simple postures (Asana), breathing exercises (pranayama) and meditation/relaxation. All the yoga participants were given handouts to practice everyday at work as its feasible
15816499|NCT04313504|Drug|Niraparib|Niraparib & Dostarlimab combination
15816500|NCT04313504|Drug|Dostarlimab|Niraparib & Dostarlimab combination
15816501|NCT04313491|Other|Yoga|Relaxation yoga exercises, yoga breathing, yoga sound and imagery practices
15816502|NCT04313478|Behavioral|Term and preterm infants|This cross-sectional study included preterm and term infants at between 3 and 9 months of age. The levels of trunk control were investigated by using the Segmental Assessment Trunk Control (SATCo). The Alberta Infant Motor Scale (AIMS) were used for assessment of gross motor performance and identify typical and atypical motor development of infants.
15816619|NCT04312386|Other|OPTIMAT|Baseline menue, not optimized
15816503|NCT04313465|Other|Immediate discharge|Participants discharged after initial blood test for cardiac troponin and risk stratification using the T-MACS decision aid
15816504|NCT04313452|Other|the effect of Mediterranean diet on insulin sensitivity among obese children and adolescents aged|to find the effect of Mediterranean diet on insulin resistance among obese children and adolescents aged 10-16 years with insulin resistance compared to the regular diet
15816505|NCT04313439|Other|Online cognitive therapy (I-CT)|"The treatment is an online cognitive therapy consisting of a structured self-help program over ten weeks, divided into eight modules, administered in an encrypted web platform. The program is based on the treatment manual The treatment of Obsessions by Stanley Rachman. In this treatment, the participant is recommended to perform daily exercises in order to identify and modify interpretations made about the importance of their obsessive thoughts. A designated therapist have email contact with the participant within the encrypted platform."
15816506|NCT04313426|Other|Integrative Yoga Therapy|Integrative Yoga Therapy included personalised yoga therapy sessions including their standard care, yoga movements, relaxation, meditation, breathing practices and yoga counselling sessions.
15816507|NCT04313413|Other|Yoga|Yoga sessions includes sukshma vyayama (strengthening yoga expertise), stretching and relaxing postures (asana) on chair or standing, breathing and meditation practices.
15816508|NCT04313400|Drug|1.1% w/w AMTX-100 CF|AMTX-100 CF, topical cream with 1.1% w/w active pharmaceutical ingredient
15816509|NCT04313400|Drug|0.33% w/w AMTX-100 CF|AMTX-100 CF, topical cream with 0.33% w/w active pharmaceutical ingredient
15816510|NCT04313400|Drug|0.11% w/w AMTX-100 CF|AMTX-100 CF, topical cream with 0.11% w/w active pharmaceutical ingredient
15816511|NCT04313400|Drug|Placebo|Topical cream manufactured to mimic AMTX-100 CF
15816512|NCT04313387|Diagnostic Test|Corneal tomography multivariate index derived from a support vector machine (CTMVI).|MATHEMATICAL ALGORITHM: To build the equation extracted from SVM, 58 variables were used, some of them were extracted from the spreadsheet.. After the construction of these 58 feature vectors (FV), an SVM-derived index was created, which was called the corneal tomography multivariate index derived from a support vector machine (CTMVI). Considering that each patient represents a point on a cartesian plane with 58 dimensions (each coordinate representing one of the 58 FV), the role of SVM is to find the hyperplane that best separates the CG, KCG, and VAE-NT G subjects. A hyperplane is algebraically described by a linear equation; in this case, there are 59 coefficients, 58 of which are related to the FV and one independent coefficient representing the bias (which is a possible parallel dislocation of a given hyperplane).
15816513|NCT04313374|Drug|Morphine PCA 1 mg|PCA will set to administer a bolus dose of 1 mg morphine on demand with a lockout period of 10 minutes and maximum 20 mg for 4 hours.
15816514|NCT04313374|Drug|Morphine PCA 0,5 mg|PCA set to administer a bolus dose of 0.5 mg morphine on demand with a lockout period of 10 minutes and maximum 20 mg for 4 hours.
15816515|NCT04313374|Drug|Placebo|the PCA will contain placebo
15816517|NCT04313348|Behavioral|eMobilize-Uganda application|"Arm 1 is the Control arm. Participants will receive no SMS reminders nor social supporter notifications. Arm 2, Scheduled SMS arm: Will receive an mHealth intervention targeted to the study participant (such as health information on an eMobilize-Uganda CommCare application or messaging and SMS reminders, or a voice call if at high risk). A weekly SMS reminder on the impending ANC appointment and expected date of delivery will be sent to participants. The content of the SMS reminders will be customized at enrolment. Arm 3 social support engagement arm: Will receive an mhealth intervention targeted to the participant plus an intervention targeted to engage the social supporter. Study participants will receive health information through the eMobilize-Uganda CommCare application or messaging + weekly SMS reminders + weekly SMS notifications to the 2 pre-identified social supporters. Notifications will bear upcoming ANC visit and delivery due date for all the study follow-up period."
15816518|NCT04313335|Drug|Duloxetine|Oral Duloxetine (up to 60 mg per day) will be given, titrated, tapered in accordance with the pain intensity during the acute herpes zoster period.
15816519|NCT04313322|Biological|WJ-MSCs|"WJ-MSCs will be derived from cord tissue of newborns, screened for HIV1/2, HBV, HCV, CMV, Mycoplasma, and cultured to enrich for MSCs.
~WJ-MSCs will be counted and suspended in 25 ml of Saline solution containing 0.5% human serum Albumin, and will be given to patient intravenously."
15816520|NCT04313309|Other|Integrative Yoga Therapy|Individualised intervention developed, consists of a six one to one sessions with patients, followed by home self practiced sessions. The intervention includes yoga movements, yoga breathing, relaxation techniques, reasoning, and other techniques designed to enhance awareness and acceptance of the psychological factors underlying the chronic pain problem.
15816521|NCT04313296|Device|Unique measurement (AutoSTRAIN) by a commercial software program (TOMTEC-ARENA)|The historic echocardiograms from patients who meet the study inclusion criteria will be uploaded into this software, which was newly acquired by the PBMC Cardiology Department. MaineHealth Information Services are currently working with study staff to assure appropriate security compliance within the network. LA GLS has not been routinely collected previously from echocardiograms performed at PBMC because of a lack of such technology.
15816522|NCT04313283|Behavioral|Parents Taking Action|A peer-led intervention, Parents Taking Action is the psychoeducational and child behavior management intervention led by trained Parent Leaders.
15816523|NCT04313270|Drug|Evolocumab|12 weeks of treatment with Evolocumab
15816524|NCT04313257|Other|Monocular Active Occlusion|Occlusion treatment of one hour daily with action video game.
15816525|NCT04313257|Other|Monocular Passive Occlusion|Occlusion treatment of two hour daily.
15816526|NCT04313244|Biological|9vHPV vaccine|9vHPV intramuscular injection
15816527|NCT04313244|Biological|Dengue Tetravalent Vaccine (TDV)|TDV subcutaneous injection
15816528|NCT04313231|Diagnostic Test|Next Generation Sequencing|"Sequencing of patient samples will be performed in the facilities of ZIMCL. Following DNA extraction, the sequencing of granulocytes as well as of lymphocytes (control) will be carried out. IN addition to whole exome sequencing, a panel from SOPHIA GENETICS (which is also available for routine diagnostics) will be applied including the following MDS specific genes: ASXL1, BRAF, CBL, CEBPA, CSF3R, DNMT3A, EZH2, FLT3, HRAS, IDH1, IDH2, KRAS, MPL, NPM1, NRAS, RUNX1, SF3B1, SRSF2, TET2, TP53, U2AF1, WT1, ZRSR. Each patient sample will be bulk sequenced, meaning that relevant mutations are detected down to an allele frequency of 2%."
15816529|NCT04313231|Diagnostic Test|Tumorimmunological examinations - multiplex assays/quantitative polymerase chain reaction|"Inflammasome activation is quantified by analyses of inflammasome-associated cytokine patterns. Multiplex assays for the quantification of the inflammasome-specific cytokines will be done from serum as well as from supernatants the stimulated blood cells. Cytokine quantification is carried out with Luminex FlexMap 3D. Serum cytokine levels will be quantitated in parallel.
~Quantification of RNA expression levels of inflammasome-related gene products will be performed by qPCRs from unstimulated and stimulated (=cryotube) blood cells. The necessary RNA extraction will be performed using a RNA extraction kit."
15816530|NCT04313231|Diagnostic Test|flow cytometry|A detailed evaluation of the individual immune status is being conducted by the analysis of two specialized panels: Panel A provides a broad overview over various immune cell populations, while Panel B identifies T-cell sup-populations.
15816531|NCT04313231|Diagnostic Test|Metagenomics of stool samples|DNA will be extracted from frozen fecal samples applying a bead-beating method using a GNOME DNA Isolation Kit (MP Biomedicals). DNA quality will be assessed using an Agilent 4200 TapeStation (Agilent Technologies). After final precipitation, DNA samples will be re-suspended in TE buffer and stored at -80 °C for further sequencing analysis. To this end, sequencing libraries will be generated using a Nextera XT DNA Sample Prep Kit (Illumina). Library quality will be confirmed using an Agilent 4200 TapeStation. Whole-genome shotgun sequencing of fecal samples will be carried out on a HiSeq2500 platform (Illumina).
15816532|NCT04313231|Diagnostic Test|Clinical/demographic data|Demographic and clinical data include: age, age at initial diagnosis, sex, diagnosis, actual comorbidities, medication at inclusion in study, cytogenetic and molecular profiles and standard laboratory parameters (blood count, differential leukocyte count, biochemistry, iron status, inflammatory markers like CRP, albumin, fibrinogen).
15816533|NCT04313231|Other|Elicitation of the HRQoL|Evaluation of HRQOL, of functional activities and of performance status will be done by the patient and/or the physician using validated scores.
15816534|NCT04313218|Drug|Carbetocin|iv infusion of 100ug carbetocin after extraction of the fetus during cesarean section
15816535|NCT04313205|Drug|JKB-122 in capsule or tablet form|JKB-122 is a TLR4 antagonist and will be administrated in capsule or tablet form
15816536|NCT04313192|Device|pulse rate of 2 Hz|electrodes placed per treatment arm, performed at bedtime, session time 15 min, frequency setting of 2 Hz, intensity setting to patient's tolerance, duration 30 days
15816537|NCT04313192|Device|pulse rate of 10 Hz|electrodes placed per treatment arm, performed at bedtime, session time 15 min, frequency setting of 10 Hz, intensity setting to patient's tolerance, duration 30 days
15816538|NCT04313192|Device|pulse rate of 150 Hz|electrodes placed per treatment arm, performed at bedtime, session time 15 min, frequency setting of 150 Hz, intensity setting to patient's tolerance, duration 30 days
15816539|NCT04313179|Other|Music therapy|Mozart lullaby music
15816540|NCT04313179|Other|Sucrose|0.5 ml of 24% Sucrose
15816541|NCT04313166|Drug|Cu(II)ATSM|cooper-containing synthetic small molecule
15816542|NCT04313153|Drug|Vadadustat|oral tablets
15816543|NCT04313153|Drug|Darbepoetin alfa|intravenous or subcutaneous solution
15816544|NCT04313140|Diagnostic Test|Diagnostic test|"The intervention occurs only one time (for 2h30), the MRI examination is divided as follow:
~Cinicial MRI (50 minutes)
~Research MRI (Phosphorus Spectroscopy, Sodium Imaging)"
15816545|NCT04313127|Biological|Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector)|Intramuscular other name:Ad5-nCoV
15816546|NCT04313114|Behavioral|health literacy appropriate education and demonstration|If a patient chooses the Fecal Immunochemical Test (FIT), the Screening Coordinator (SC) will give the FIT kit, emphasize the necessity of annual completion, and distribute an additional plain language, literacy appropriate, actionable handout with simplified illustrated instructions on how to complete the test and mail to the central lab. The SC will review the handout and instructions with the patient and use the 'teach back' method to confirm understanding.
15816547|NCT04313114|Behavioral|shared decision making|Screening Coordinator (SC) will give patients a plain language, literacy appropriate, actionable printed CRC screening handout emphasizing the benefits of CRC screening and screening options; using the low literacy handout as a teaching tool, the SC will briefly counsel patients on CRC screening options prior to seeing their healthcare provider, reviewing the benefits of each, as well as applicable costs. After reviewing the CRC screening pamphlets with a patient, the SC will use shared decision-making techniques using the study CRC materials to aid patients in selecting the test they prefer and that meets their needs - colonoscopy or FIT.
15816548|NCT04313114|Behavioral|automated call reminders or automated texts|"Colonoscopy year 1: Will receive an automated call recording by PCP 48 hours after the clinic visit to remind them of their choice of colonoscopy; then, one week before the test reminding them to pick up the preparation kit. Those who chose SMS will receive a text message from their PCP with content similar to the voice call. A 3rd reminder call/text will be sent 2 days prior to the test. If no colonoscopy with 3 months, the clinical manager (CCM) will call to determine if they want to switch screening options. The CCM will discuss barriers and option of choosing FIT for 3 years. If they opt to change, they will be mailed a FIT with simplified instructions and then follow the FIT follow-up protocol.
~FIT year 1: Motivational reminders recorded by their PCP will be sent by automated call or text within 48 hours after the visit and again at 4, 8 and 12 weeks for those who have NOT completed the test. FIT will be mailed year 2 & 3 - follow-up will follow same procedure as year 1."
15816549|NCT04313101|Other|withdrawl of blood samples for thyroid function testing|"Blood samples will be withdrawn from patients admitted to the intensive care for more than 7 days to measure Thyroid hormones (Free T3: Tri-iodothyronine and Free T4:thyroxine) and TSH ( Thyroid Stimulating Hormone) using ELISA kits. Reference ranges will be as follows: TSH 0.4-4mU/L, Free T3 2-4.4 mU/L, Free T4 0.8-1.9 mU/L. Patients will be then categorized into one of the following categories
~Euthyroid ( Normal TSH, FT3 and FT4)
~Hyperthyroid (Low TSH) either overt (increased FT3 and /or FT4) or subclinical (normal FT4 and FT3).
~Hypothyroid (Elevated TSH) either overt (Low FT3 and FT4) or subclinical (Normal FT3 and FT4)
~Non-thyroidal illness syndrome : normal or low TSH in addition to low FT3 ± Low FT4 levels."
15816550|NCT04313088|Drug|Eluxadoline 100 mg|Eluxadoline 100mg by mouth twice daily with food
15816551|NCT04313075|Drug|Leronlimab|Leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
15816653|NCT04312100|Other|oxygen treatment|different kinds of oxygen treatments will be given to patients according to their state of illness
15816552|NCT04313062|Behavioral|Educational Intervention|"An educational intervention based on the PM ACTIVAS' model and a  Falling Prevention Kit , both in a home visit by the trainees. Also, a telephone follow-up and a last house call 12 months after recruiting to assess the changes implemented by the person and their family, to conduct the final survey and to ask for the  Falls and Events Calendar  ."
15816553|NCT04313049|Device|JACO2|Performing tasks using joystick control
15816554|NCT04313049|Device|VOCAL CONTROL|Performing tasks using vocal control
15816555|NCT04313036|Drug|Defibrotide|25 mg/kg/day at 4 divided doses of 6.25 mg/kg, 2-h infusion given for 5 days, if not in CR treatment continued for >/= 21 days or per discretion of enrolling physician.
15816556|NCT04313023|Drug|PUL-042 Inhalation Solution|20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042) PUL-042 Inhalation Solution
15816557|NCT04313023|Drug|Placebo|Sterile saline for inhalation
15816558|NCT04313010|Other|PRF|A sample of whole venous blood was drawn from the patient's forearm. The blood sample was transferred into a tube without anticoagulant and centrifuged immediately using a centrifuge.
15816559|NCT04313010|Other|BC|According to the procedures of regenerative endodontics therapy, BC was made by the way of provoking apical bleeding into root canal.
15816560|NCT04312997|Drug|PUL-042 Inhalation Solution|20.3 µg Pam2 : 29.8 µg ODN/mL (50 µg PUL-042)
15816561|NCT04312997|Drug|Placebo|Sterile saline for inhalation
15816562|NCT04312971|Drug|Placebo|Patients undergoing different cardiac surgical procedures will receive a continuous intravenous infusion of Normal Saline 0.9% with a starting dose of 0.0025 ml/kg/min.
15816563|NCT04312971|Drug|Norepinephrine|Patients undergoing different cardiac surgical procedures will receive a continuous intravenous infusion of norepinephrine (40 ug/ml) with a starting dose of 0.0025 ml/kg/min.
15816564|NCT04312971|Other|Increase infusion rate|Infusion rate will be increased as needed in order to maintain a MAP ≥65 mmHg during cardiopulmonary bypass period as per the discretion of the anesthesiologist using 0.00125 ml/kg/min increments
15816565|NCT04312971|Other|Decrease infusion rate|Infusion rate will be decreased as needed in order to maintain a MAP ≥65 mmHg during cardiopulmonary bypass period as per the discretion of the anesthesiologist using 0.00125 ml/kg/min decrements
15816566|NCT04312958|Diagnostic Test|Quantra System|Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
15816567|NCT04312945|Other|Questionnaires|The participant will complete questionnaires, including ones on pubertal development and quality of relations with parents and friends.
15816568|NCT04312945|Other|MRI|Within 2 weeks of the first study visit, the participant will return to the University where they will undergo MRI.
15816569|NCT04312932|Drug|LCPUFA Oil Supplement|25 mg/kg, 50 mg/kg, or 75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
15816570|NCT04312932|Dietary Supplement|Canola Oil Placebo|Equal volume (25 mg/kg, 50 mg/kg, or 75 mg/kg) of placebo (canola) oil to be administered twice per day by mouth for 90 days
15816571|NCT04312919|Behavioral|Family Based Activity Intervention|Providing youth and their families with access to the knowledge and resources to increase their physical activity will allow them to lead more healthy lifestyles will provide them with the foundation for a healthier life, and future ahead.
15816572|NCT04312906|Other|no intervention|No intervention
15816573|NCT04312893|Other|Acupuncture (Press Tack Needle)|Press Tack Needle (PYONEX made by Seirin Corporation). The needles appear identical to the press tack placebo with the only different is the needle itself which was removed in the placebo needles.
15816574|NCT04312893|Other|press tack placebo|press tack placebo (made by Seirin Corporation), which looks identical to press tack needles but, with no needle element.
15816575|NCT04312880|Drug|Tranexamic Acid|IV and topical form of TXA will be administered to patients in the respective groups.
15816576|NCT04312867|Behavioral|Project STRONG|Project STRONG is a 6-module web-based, dyadic intervention for middle school boys and their parents to complete. Its goal is primary prevention of adolescent dating violence by targeting parent-child communication and emotion regulation ability.
15816577|NCT04312867|Behavioral|Health Promotion|Health promotion is a 6 module web-based, health information program designed to provide health content similar to that provided in a middle school health class. This program is designed to mirror Project STRONG for time and delivery method.
15816578|NCT04312841|Drug|Letermovir|Given PO
15816579|NCT04312828|Procedure|Orthopedic management of the Z-foot|Orthopedic treatment with femoropedic plasters and slotted splints in 1st intention
15816580|NCT04312815|Drug|SM03|SM03: 600 mg intravenous (IV)
15816581|NCT04312815|Drug|Placebo|Placebo: 600 mg intravenous (IV)
15816582|NCT04312815|Drug|MTX|Methotrexate: 7.5-20 mg/wk oral
15816583|NCT04312802|Diagnostic Test|Cardiopulmonary exercise test (CPET)|"The participant will undergo a cardio-pulmonary exercise test (CPET) on a cycle ergometer (Ergoline) connected to a 12-lead electrocardiogram, oxygen saturation monitor and continuous non-invasive blood pressure cuff. Respiratory gas exchanged will be measured from a tight fitting facemask. An initial 2-min period of baseline data will be collected at rest before a 180-s period of unloaded cycling. A ramp protocol will then be applied and the participant will be instructed to continue cycling at a constant cadence of 60 rpm as long as they can. The test will be terminated if the participant indicates that:
~they cannot continue
~cadence falls to <55 rpm due to fatigue or dyspnoea
~they develop abnormal cardiac signs or symptoms, such as ischaemia and arrhythmia."
15816584|NCT04312789|Drug|Avatrombopag|Given PO
15816585|NCT04312776|Other|none intervention|
15816586|NCT04312750|Drug|Lidocaine topical system 1.8%|
15816587|NCT04312737|Device|Self-Collecting Devices|FLOQSwab (Copan) Colli-Pee (Novosanis)
15816588|NCT04312737|Diagnostic Test|In Vitro Diagnostic Assays|Papilloplex (GeneFirst) HPV Oncopredict DNA (Hiantis) HPV Oncopredict RNA (GeneFirst)
15816620|NCT04312373|Other|Ankle Foot Orthosis|"According to the SCED methodology, patients were fitted with ankle foot orthosis intermittently, during 4 phases, in the following order : without orthosis (A1), with orthosis (B1), again without orthosis (A2) and again with orthosis (B2).
~All the phases were carried out over one day."
15816652|NCT04312113|Drug|Adipose derived, autologous mesenchymal stem cells|Fat tissue will be enzymatically treated and cells will be cultured until a sufficient number are obtained for the treatment protocol.
15816589|NCT04312724|Device|Direct Socket TF|"The device is Class I, a low-risk product, and is a further development of a well-established technology. Össur Direct Socket (DS) technology has been on the market since 1996 (ICEX first generation) for the manufacture of leg prosthesis. This prosthetic socket for trans-femoral amputees (referred hereby to as DS-TF) has the same basic functional design as the Direct Socket (MSS) for trans-tibial amputees (referred hereby to as DS-TT) that is available on the market today in addition to the newly added silicon brim.
~A prosthetic socket is a non-invasive, non-sterile, single user reusable device, which is used as part of prosthetic system. The aspect of the prosthesis that is in direct physical contact with the amputee is usually not the socket, to which a prosthesis is connected to, but the liner that serves as an interface between the amputee and the rest of the prosthesis. An amputee typically wears a prosthesis and thereby utilizes a socket, for up to 18 hours a day."
15816590|NCT04312711|Diagnostic Test|3D-TOF-MRA|"The Principle of 3D-TOF-MRA is based on the flow effect of MR. In the GE sequence of MRA imaging, the effect of RF pulses makes the protons in the stationary tissue in the active layer in a saturated state, and the longitudinal magnetization disappears. When the inflow blood appears, its protons are in an unsaturated state and have a high degree of longitudinal magnetization. In this way, a clear difference is formed between saturated tissue and unsaturated flowing blood to display blood vessels. 3D-TOF-MRA is a non-invasive and safe method for diagnosing vascular diseases."
15816591|NCT04312698|Drug|D013, D326, D337|Experimental: Group 1 Patients assigned to this group are treated with D013, D326, D337
15816592|NCT04312698|Drug|placebo of D013, D326, D337|Placebo Comparator: Group 1 Patients assigned to this group are treated with D326, D337, placebo of D013
15816593|NCT04312698|Drug|D013, placebo of D326, placebo of D337|Placebo Comparator: Group 2 Patients assigned to this group are treated with D013, placebo of D326, placebo of D337
15816594|NCT04312685|Device|Prometra II Programmable Pump system - Flowonix Medical|This valve gated Prometra II Programmable Pump system will be replacing prior peristaltic Synchromed II pump
15816597|NCT04312646|Device|Elastography .|Performance of US, elastography
15816598|NCT04312607|Diagnostic Test|BCR-ABL gene PCR|peripheral blood sampling for detection of Philadelphia chromosome and flowcytometry for detection of CD26 positive stem cells
15816599|NCT04312594|Drug|Jaktinib Dihydrochloride Monohydrate 50mg BID and Mimic tablets of jakitinib hydrochloride 75mg BID and Acetylcysteine Effervescent Tablets|after continuing to intolerance or progress in double blind treatment period for 24 weeks,for tolerance into open therapy period for evaluated by investigator
15816600|NCT04312594|Drug|Jaktinib Dihydrochloride Monohydrate 75mg BID and Mimic tablets of jakitinib hydrochloride 50mg BID and Acetylcysteine Effervescent Tablets|after continuing to intolerance or progress in double blind treatment period for 24 weeks,for tolerance into open therapy period for evaluated by investigator
15816601|NCT04312594|Drug|Placebo oral tablet and Acetylcysteine Effervescent Tablets|after continuing to intolerance or progress in double blind treatment period for 24 weeks,for tolerance into open therapy period for evaluated by investigator
15816602|NCT04312581|Device|Extracorporeal shock wave therapy|3 sessions of radial- extracorporeal shock wave therapy rESWT one week apart, 2000-3000 impulses at 0.25-0.84 millijoule /mm2with a pressure 2.8 bar and 15 Hz frequency.
15816603|NCT04312581|Other|Conventional rehabilitation|physical & occupational therapy
15816604|NCT04312568|Drug|Fadanafil|Dose escalation for 8 groups: 12.5mg one dose, 25mg one dose, 50mg one dose, 100mg one dose, 200mg one dose, 300mg one dose, 400mg one dose, 500mg one dose
15816605|NCT04312568|Drug|Placebo|Dose escalation for 8 groups: 12.5mg one dose, 25mg one dose, 50mg one dose, 100mg one dose, 200mg one dose, 300mg one dose, 400mg one dose, 500mg one dose
15816606|NCT04312555|Drug|Alprostadil|Alprostadil intravenous administration. (0.5 mg/1ml of Alprostadil + 49cm saline 0.9%) and 4 cm direct intravenously / 8 hours
15816607|NCT04312542|Procedure|Measurement of Biomarkers|Participants will have blood drawn at a 9-month and 12-month visit for the measurement of biomarkers.
15816608|NCT04312529|Other|Isokinetic test + EMG|Isokinetic test:The isokinetic device is used to evaluate the strength of a subject. The test will be performed in two positions. This will determine the best position to activate shoulder muscles EMG (electromyography):it's a device that measures the electrical activity of muscles. This will allow us to record the maximum activity of the shoulder muscles during force tests.
15816609|NCT04312503|Drug|Lurasidone|Patients are treated with dosages according clinical practice
15816610|NCT04312503|Drug|aripiprazole, olanzapine, quetiapine or risperidone|Patients are treated with dosages according clinical practice
15816611|NCT04312490|Diagnostic Test|endomyocardial biopsy|Endomyocardial biopsies will be stained with Masson's trichrome as well as Giemsa and examined by light microscopy. For immunohistology, tissue sections will be treated with an avidin-biotinimmunoperoxidase method (Vectastain-Elite ABC Kit, Vector, Burlingame, Calif), with application of the following monoclonal antibodies: CD3 (T cells; Novocastra Laboratories, Newcastle, UK), CD68 (macrophages, natural killer cells; DAKO, Hamburg, Germany), and HLA-DR-α (DAKO, Hamburg, Germany
15816612|NCT04312477|Drug|Modified Gegen Qinlian Decoction|Modified Gegen Qinlian Decoction contains Pueraria lobata 24g, Scutellaria baicalensis 9g, Coptis chinensis 9g, artillery ginger 9g, talc 9g, roasted licorice 6g, and granules are prepared according to 10:1 production process.
15816613|NCT04312464|Other|non|no intervention
15816614|NCT04312438|Diagnostic Test|oral food challenge with cow's milk proteins|in children with diagnosed Cow's Milk Allergy open oral food challenge test with cow's milk protein (milk formula in children up to 3 yo, cow,s milk after 3 yo) will be carried out
15816615|NCT04312425|Procedure|Modified rapid sequence induction|Modified RSI was put into use in day shift emergency surgery since March 1, 2018. In this scheme, dorsal elevated position and apneic oxygenation technic are applied. Positive pressure mask ventilation is avoided unless necessary. Sellick's technic is not used in this scheme.
15816616|NCT04312425|Procedure|Classic rapid sequence induction|In classic RSI scheme, patients are in supine position during induction and intubation. Sellick's technic is applied after sedatives and muscle relaxant are given.
15816617|NCT04312412|Procedure|Controlled active motion (CAM)|Rehabilitation, post-surgery protocol
15816618|NCT04312399|Procedure|blood take|Blood is taken to analyse degratdation products of the metabolism of amyloid
15816621|NCT04312360|Drug|therapeutic endoscopy with metronidazole and fosfomycin disodium|therapeutic endoscopy where the two drugs: metronidazole and fosfomycin disodium are sprayed through out the right colon section (from caecum to right colon flexure). This intervention is going to be performed on patients in both track 1 and track 2a.
15816622|NCT04312347|Drug|Tamoxifen dose adjustment|Patients with low endoxifen level and poor/intermediate metabolizer CYP2D6 phenotype will receive tamoxifen dose escalation into 40 mg/day.
15816623|NCT04312334|Other|Control|Soap: Non-antimicrobial bar soap will be used as a reference product for four of the the experiments. Hand-cleaning with SuperTowel will be the reference produce for two of the experiments.
15816624|NCT04312334|Other|Treatment|The Supertowel is a durable fabric with a permanent anti-microbial treatment. The treated fabric must be dipped in water and then rubbed against the hands so that pathogens will be transferred to the fabric where they will be killed.
15816625|NCT04312321|Device|Mandatory phone call consultation|Use of audio consultation (EMS crew smartphones, doctor smarphone) Smartphone (Xiaomi Redmi Note) and bluetooth handsfree headset (Jabra Talk)
15816626|NCT04312321|Device|Mandatory audiovisual consultation|Smartphone (Xiaomi Redmi Note) and bluetooth handsfree headset (Jabra Talk) with installed Android application (VSee messenger, USA, HIPAA compliant software) for paramedic crews; personal computer (Windows 10) with desktop version of application VSee messenger for Windows and eqipped with webcamera (Logitech C922 PRO) and headset (Jabra Evolve 20) for consulting doctor.
15816627|NCT04312308|Other|Sample collection|".Analysis of immune marker using FACS before treatment and Cycle1, Cycle2, Cycle3 and the time of disease progression.
~.Multiplexed biomarker analysis of tumor and immune cells in tumor microenvironment (TME) at pre-treatment and progression (Pre-treatment biopsy is mandatory but biopsy is optional for disease progression)
~3. microbiome Pretreatment stool sample will be collected. (Stool sample is optional)
~4.Genetic analysis For RNAseq or exome seq, biopsied tissue at baseline or progression are optional.
~4.Single cell RNA sequencing (scRNA-seq) scRNA-seq will be performed by collecting selectively tissues from pre-treatment tumor biopsies and at relapse/acquired resistance tumor biopsies. Screening and treatment biopsies are optional."
15816628|NCT04312295|Behavioral|ACP-SCT program|The ACP-SCT program was designed to improve nurses' knowledge and competence in discussing ACP with Chronic Kidney Disease patients.
15816629|NCT04312282|Drug|Tesetaxel|Tesetaxel orally on Day 1 of a 21-day cycle
15816630|NCT04312282|Drug|Tesetaxel|Tesetaxel orally on Day 1 of a 21-day cycle
15816631|NCT04312282|Drug|Itraconazole|Itraconazole orally once daily from Day -3 to Day 14 of a 21-day cycle
15816632|NCT04312282|Drug|Rifampin|Rifampin orally once daily from Day -6 to Day 14 of a 21-day cycle
15816633|NCT04312269|Other|Targeted Memory Reactivation (TMR)|Targeted memory reactivation (TMR) refers to the process of playing audio cues associated with specific learned material quietly during sleep in order to strengthen consolidation of specific memories during sleep.
15816635|NCT04312243|Drug|Inhaled nitric oxide gas|Control group: a SARS-CoV2 rt-PCR will be performed if symptoms arise. Treatment group: the subjects will breathe NO at the beginning of the shift and before leaving the hospital. Inspired NO will be delivered at 160 parts per million (ppm) for 15 minutes in each cycle. A SARS-CoV-2 rt-PCR will be performed if symptoms arise. Safety: Oxygenation and methemoglobin levels will be monitored via a non-invasive CO-oximeter. If methemoglobin levels rise above 5% at any point of the gas delivery, inhaled NO will be halvened. NO2 gas will be monitored and maintained below 5 ppm.
15816636|NCT04312217|Behavioral|Medical clowning|Medical clowning
15816637|NCT04312204|Drug|Sintilimab combined with Gemcitabine and Carboplatin|"The patients will received Gemcitabine1000mg/m2(d1,d8)(iv)+carboplatin AUC 5 (d1)(iv),4 cycles, Sintilimab 200 mg (3mg/kg when the weight <40kg ) (d1) (iv) in one cycle every 3 weeks, until PD or death.
~Radiological examinations (according to the RECIST 1.1 criteria) at baseline will be repeated for tumor response evaluation following every two cycles of chemotherapy. Patients will be followed up to 30 days after the last dose of study chemotherapy, and then every 3 months."
15816638|NCT04312191|Other|Mantra Meditation|Mantra-based meditation will be taught using a standard one-word mantra (Om). Om is a non-English word that will help with focus as opposed to an English word which may cause distraction based on the word itself.
15816639|NCT04312178|Other|cash incentive|cash incentive (20€ gift card)
15816640|NCT04312178|Other|no intervention|no intervention
15816641|NCT04312178|Other|return vaginal self-swab kit in person|hand-delivered to a health care professional to encourage discussion of cervical cancer prevention
15816642|NCT04312165|Device|Duramesh Laparotomy Closure|Closure of midline laparotomy incision with experimental suture
15816643|NCT04312165|Device|Conventional suture closure|Closure of midline laparotomy incision with standard suture
15816644|NCT04312152|Dietary Supplement|Q10 Ubiquinol|Q10 Ubiquinol (50 or 100 mg b.i.d. depending on body weight) in capsules containing also Vit. E and Vit. B complex, as described above. Capsules can be opened and the content drunk or chewed, if children have difficulties with swallowing capsules.
15816645|NCT04312152|Dietary Supplement|Vitamin E|Vitamin E (30 mg b.i.d. regardless of body weight) in capsules containing also Vit. B complex, and, in the active arms, Q10 ubiquinol. Capsules can be opened and the content drunk or chewed, if children have difficulties with swallowing capsules.
15816646|NCT04312152|Dietary Supplement|Multi-Vitamin B complex|Multi-Vitamin B complex including Vit. B1, B2, B3, B5, B6, B8, B9, and B12, in capsules containing also Vit. E and, in the active arms, Q10 ubiquinol. Capsules can be opened and the content drunk or chewed, if children have difficulties with swallowing capsules.
15816647|NCT04312139|Diagnostic Test|Echocardiography|Baseline and prospective follow-up echocardiography
15816648|NCT04312139|Diagnostic Test|Computerized Tomography Aortic Valve Calcium Score|Baseline and prospective follow-up CT calcium score of aortic valve
15816649|NCT04312139|Other|Untargeted LC/MS and LC-MS/MS|Serum samples untargeted proteomics and metabolomics
15816650|NCT04312139|Other|Targeted LC/MS and LC-MS/MS|Serum samples targeted proteomics and metabolomics
15816651|NCT04312139|Diagnostic Test|multiplex ELISA|Implementation of novel multiplex ELISA assay on serum samples of aortic valve stenosis prospective cohort.
15816654|NCT04312087|Procedure|Lateral neck sentinel lymph node biopsy|Lateral neck sentinel lymph node biopsy is performed in all patients in Arm B.
15816655|NCT04312087|Procedure|Modified lateral neck lymph node dissection|Modified lateral neck dissection (compartment II-V) is performed in all patients in Arm A, and some of the patients in Arm B (according to sentinel lymph node biopsy results).
15816656|NCT04312087|Procedure|Super selective lateral neck lymph node dissection|Super selective lateral neck lymph node dissection is performed in some of the patients in Arm B (according to sentinel lymph node biopsy results).
15816657|NCT04312061|Drug|oral tramadol|oral tramadol tablet 5o mg given 1 hour before LNG-IUD insertion
15816658|NCT04312061|Drug|Placebo oral tablet|oral placebo tablet given 1 hour before LNG-IUD insertion
15816659|NCT04312048|Drug|Isosorbide mononitrate|one tablet of Isosorbide Mononitrate (40 mg) vaginally 3 hours prior to copper IUD insertion
15816660|NCT04312048|Drug|placebo|one tablet of placebo vaginally 3 hours prior to copper IUD insertion
15816661|NCT04312035|Procedure|end-range mobilization|accessory technique applied on the tibiofemoral joint with the aim of increasing extensibility of the periarticular tissues
15816662|NCT04312035|Procedure|Non end-range mobilization|accessory technique applied on the tibiofemoral joint with the aim of alleviating pain
15816663|NCT04312035|Procedure|Control|hands-on cutaneous technique
15816664|NCT04312022|Dietary Supplement|Berry extract|Berry extract supplement (hawthorn berry extract, tart cherry extract, bromelain)
15816665|NCT04312022|Other|Placebo|Placebo (flour capsule)
15816666|NCT04312009|Drug|Losartan|Losartan; 50 mg daily; oral administration
15816667|NCT04312009|Other|Placebo|Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration
15816668|NCT04311996|Other|Questionnaires|The participant will complete questionnaires, including ones on pubertal development and quality of relations with parents and friends.
15816669|NCT04311996|Other|MRI|Within 2 weeks of the first study visit, the participant will return to the University where they will undergo MRI.
15816670|NCT04311983|Behavioral|Tobacco Quitline|"Tobacco quitlines provide phone counseling from a quit coach, often supplemented with NRT (nicotine replacement therapy), a quit guide, text messages, or other support. Smokers can call directly or consent to be called by the quitline (fax-back)."
15816671|NCT04311983|Behavioral|Smoke Free Home|The intervention guides participants though a 5-step process: (1) deciding to create a smoke-free home; (2) talking about it with household members; (3) setting a date for the home to become smoke-free; (4) making the home smoke-free; and (5) keeping the home smoke-free. Progress from one step to the next is facilitated over a 6-week period by three mailings sent to participants' homes and one telephone counseling call delivered by a trained smoke free homes coach.
15816672|NCT04311970|Device|EsoCheck|All patients with known diagnosis of EoE will be administered the EsoCheck device prior to standard of care endoscopy
15816673|NCT04311957|Drug|Continuation of boosted PI|"Continuation of the same second-line regimen taken prior to entry:
~LPVr 400 mg/100 mg BID or ATVr 300 mg/100 mg QD + 2 NRTIs"
15816674|NCT04311957|Drug|B/F/TAF|Single-tablet, fixed dose combination of bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg (B/F/TAF) administered orally, once daily.
15816675|NCT04311944|Other|Early fast-track care|Participants will be eligible for fast-track care at 8 weeks if their HIV-1 RNA is <200 copies/mL and they meet other eligibility criteria. If HIV-1 RNA is 200 copies/mL or higher at 8 weeks, then it will be repeated at 12 weeks, and those with HIV-1 RNA <200 copies will then be eligible for fast-track care, if they meet other eligibility criteria.
15816676|NCT04311944|Other|Standard (deferred fast-track) care|Participants will be eligible for fast-track care at 24 weeks, if their HIV-1 RNA is <200 copies.mL, and they meet other eligibility criteria.
15816677|NCT04311931|Other|Active Dance Program|All Creative Dance sessions comprised five phases: 1) opening ritual (5 min), in which participants will be welcomed and will be informed about the objectives and structure of the session; 2) warm-up (15 min), in which body muscle groups will be activated through the introduction of basics elements of movement; 3) main phase (30 min), will be proposed individual, pair and group activities, in order to achieve the objectives described above. This phase will end with a choreography composition; 4) cool-down (5 min) with stretching and physiological parameters normalization; and 5) ending ritual (5 min), in which the participants will be invented to share their sessions' experience and they will fill a sheet with attendance, exercise intensity perception (Borg Scale) and satisfaction's (Caregiver Treatment Satisfaction questionnaire).
15816678|NCT04311905|Device|Diode laser|Diode laser activated irrigation
15816679|NCT04311905|Other|Placebo|mock Laser activated irrigation
15816680|NCT04311892|Diagnostic Test|EMG of the hip abductor muscles|EMG will be carried out to examine the (superior gluteal nerve) SGN for all patients. The muscles will be evaluated according to the criteria of the American Academy of Electrophysiological Medicine for needle EMG. In order to exclude patients with polyneuropathy, radiculopathy, or plexopathy, nerve conduction studies of both lower extremities will be performed. Then, gluteus medius muscles will be assessed bilaterally to evaluate the SGN, the vastus medialis muscle for L4 root, tibialis anterior muscle for L5 root, and gastrocnemius muscle for S1 root.
15816681|NCT04311879|Device|Soft tissue Diode laser application|post-operative soft tissue diode laser application
15816682|NCT04311879|Other|Placebo|mock diode laser application
15816683|NCT04311866|Device|Synthetic pants|The use of synthetic materials is preferred (glass fiber), resistance, durability and low weight makes them optimal. To give some extra strenght to the cast, fiber strips are placed anterior and posterior at the level of the groin, this can facilitate the transportation of the patient avoiding the use of a bar.
15816684|NCT04311866|Device|Spica cast|The use of the spica cast is a standard practice for the management of the femoral shaft fractures, however its use, under some circumstances has been related to a wrong management of the cast, auto-retrieval, patient discomfort, and a difficult situation trying to maintain personal hygiene for the patient.
15816685|NCT04311827|Other|Serratus Anterior Plane Block|Injection of bupivacaine 75mg above the serratus anterior facial plane in the anterior axillary line
15816686|NCT04311814|Diagnostic Test|Maximum urethral closure pressure during Valsalva (v-MUCP)|v-MUCP measurement was performed for all patients referred for urodynamic exploration of the lower urinary tract
15816687|NCT04311801|Diagnostic Test|Optical Coherence Tomography|Every patient underwent OCT examination before and after surgery.
15816688|NCT04311788|Device|Prophylactic self gripping mesh|Prophylactic self gripping mesh, Propgrip by Medtronic.
15816689|NCT04311788|Device|Slowly absorbable continuous monofilament suture|Fascial closure by continuous slowly absorbable 4:1 suture
15816690|NCT04311775|Device|larengeal mask insertion with video laryngoscopy|it is a method of inserting a laryngeal mask into the airway with videolaryngoscopy
15816691|NCT04311775|Other|laryngeal mask insertion|laryngeal mask is a method of inserting atube into the upper airway
15816692|NCT04311762|Drug|cisplatin|Intratumoral delivery of cisplatin via bronchoscopy (endobronchial ultrasound)
15816693|NCT04311749|Genetic|Expanded panel cell free DNA testing (non-invasive prenatal testing)|Maternal blood sampling
15816694|NCT04311749|Genetic|Placental biopsy|Post-delivery placental sampling
15816695|NCT04311749|Genetic|Umbilical cord blood|Post-delivery umbilical cord blood sampling
15816696|NCT04311736|Behavioral|Exergame|Cycling on a recumbent cycle ergometer + Virtual Reality Cognitive Training
15816697|NCT04311736|Behavioral|Cycling|Cycling on a recumbent cycle ergometer
15816698|NCT04311736|Behavioral|Stretching|Stretching exercises
15816699|NCT04311723|Procedure|Anesthesia Procedure|Receive anesthesia using laryngeal mask
15816700|NCT04311723|Procedure|Anesthesia Procedure|Receive anesthesia using endotracheal tube
15816701|NCT04311723|Procedure|Bronchoscopy|Undergo standard of care bronchoscopy
15816702|NCT04311710|Drug|ipilimumab|Specified Dose on Specified Days
15816703|NCT04311710|Drug|nivolumab|Specified Dose on Specified Days
15816704|NCT04311710|Drug|ENHANZE (rHuPH20)|Specified Dose on Specified Days
15816705|NCT04311710|Drug|nivolumab|Specified Dose on Specified Days
15816706|NCT04311697|Drug|Aviptadil by intravenous infusion + standard of care|Aviptadil by intravenous infusion + standard of care (SOC). SOC is defined not to include extracorporeal mechanical oxygenation. Those requiring ECMO will be withdrawn from the study as treatment failures.
15816707|NCT04311697|Drug|Normal Saline Infusion + standard of care|Saline by intravenous infusion + standard of care (SOC). SOC is defined not to include extracorporeal mechanical oxygenation. Those requiring ECMO will be withdrawn from the study as treatment failures.
15816708|NCT04311684|Device|hybrid Brillouin-Raman spectroscopy|Combination of Brillouin and surface-enhanced Raman (SERS) spectroscopy for assessment of both visco-elastic (i.e. mechanical) and chemical characterization of urinary proteins at the same time from the same excitation laser source
15816709|NCT04311671|Drug|Moxidectin|2mg tablets, encapsulated for blinding
15816710|NCT04311671|Drug|Ivermectin|3mg tablets, encapsulated for blinding
15816711|NCT04311658|Drug|Isosorbide Mononitrate 40 MG|one tablet of Isosorbide Mononitrate (40 mg) vaginally 3 hours prior to LNG- IUD insertion
15816712|NCT04311658|Drug|Placebo|one tablet of placebo vaginally 3 hours prior to LNG-IUD insertion
15816713|NCT04311645|Drug|Activated charcoal|Activated charcoal
15816714|NCT04311645|Dietary Supplement|Dry seeds|Dry seeds
15816715|NCT04311632|Biological|TCD601|Investigational Product
15816716|NCT04311632|Drug|Tacrolimus (TAC)|Standard of Care Concomitant Immunosuppression
15816717|NCT04311632|Drug|Corticosteroids (CS)|Standard of Care Concomitant Immunosuppression
15816718|NCT04311632|Drug|Mycophenolate Mofetil (MMF)|Standard of Care Concomitant Immunosuppression
15816719|NCT04311632|Drug|ATG|Standard of Care induction therapy in solid organ transplantation
15816720|NCT04311619|Drug|[11C]UCB-J radiotracer|I.V. bolus administration of up to 15 mCi (equivalent to 0.3 rems) in the antecubital vein per injection
15816721|NCT04311619|Device|PET-MR|Positron emission tomography and magnetic resonance imaging, with a scan duration of up to 120 minutes
15816722|NCT04311606|Drug|Sub-tenon injection of saline followed by a sub-tenon injection of aflibercept|The study will randomly assign a total of eight subjects into this treatment arm to receive a sub-tenon injection of saline followed by injection of 4 mg aflibercept (total volume 1.1 ml) in the worse eye. Injections will be given three times: on day 1, day 14 and day 28. Subjects will be followed until day 90.
15816723|NCT04311606|Drug|Sub-tenon injection of hyaluronidase (HA) followed by a sub-tenon injection of aflibercept|The study will randomly assign a total of eight subjects into this treatment arm to receive a sub-tenon injection of hyaluronidase (HA) followed by injection of 4 mg aflibercept (total volume 1.1 ml) in the worse eye. Injections will be given three times: on day 1, day 14 and day 28. Subjects will be followed until day 90.
15816724|NCT04311606|Drug|Sub-tenon injection of hyaluronidase (HA) alone|The study will randomly assign a total of eight subjects into this treatment arm to receive a sub-tenon injection of hyaluronidase (HA) injection alone (total volume 1.0 ml) in the worse eye. Injections will be given three times: on day 1, day 14 and day 28. Subjects will be followed until day 90.
15816725|NCT04311593|Diagnostic Test|CD4, CD19, CD38, CD56 and CD11b|measuring CD markers by flowcytometry
15816726|NCT04311580|Combination Product|intravesical electromotive administration of mitomycin|
15816727|NCT04311567|Drug|Tofacitinib|Open-label tofacitinib for 48 weeks. All subjects (both arms) receive prednisone starting at 20 mg QD with tapering for 6 weeks. Patients with incomplete response at 24 weeks will escalate to combination therapy with tofacitinib 5 mg BID + methotrexate 20 mg weekly up to week 48.
15816728|NCT04311567|Drug|Methotrexate|Open-label methotrexate for 48 weeks. All subjects (both arms) receive prednisone starting at 20 mg QD with tapering for 6 weeks. Patients with incomplete response at 24 weeks will escalate to combination therapy with tofacitinib 5 mg BID + methotrexate 20 mg weekly up to week 48.
15816729|NCT04311528|Biological|9-valent HPV vaccine|9-valent HPV vaccine
15816730|NCT04311515|Radiation|Tau Positron emission tomography (PET)|Tau PET imaging enables the longitudinal assessment of the spatial pattern of tau deposition. Tau accumulates with progression of AD dementia and may be sensitive to disease related changes, particularly those due to intervention with a drug thought to work through a tau related mechanism. Quantitative assessments will be utilized to evaluate the target engagement and pharmacological effects of PU-AD after 6 months of treatment
15816796|NCT04311099|Procedure|Injection of Ropivacaine - Ultrasound-guided transverse abdominal plane block|Lateral ultrasound-guided transverse abdominal plane block 40 ml ropivacaine 2 mg / ml
15816797|NCT04311099|Procedure|Injection of Ropivacaine - Laparoscopic assisted transverse abdominal plane block|Laparoscopic assisted subcostal transverse abdominal plane block 40 ml ropivacaine 2 mg / ml
15816731|NCT04311515|Radiation|Fluorodeoxyglucose (FDG) Positron emission tomography (PET)|Measurement of neuronal function with FDG PET can help to understand the relationship between target engagement and potential clinical effects. FDG PET will be acquired using stringent quality control. Since glucose metabolism captures all neuronal activity, in order to isolate effects due to treatment, patients will be maintained in a consistent state during the tracer uptake period. Subject motion during image acquisition will be minimized and monitored. Images will be quality controlled, processed, and measured quantitatively using methods that maximize signal to noise associated with technical and physiologic variability
15816732|NCT04311515|Diagnostic Test|Cerebrospinal fluid (CSF) Biomarkers|A broad set of biomarkers are being assessed in this study to indicate whether this treatment is able to impact multiple pathways associated with AD related to neurodegeneration
15816733|NCT04311515|Diagnostic Test|Blood Biomarkers|Changes in blood biomarkers may be observable if treatment affects cerebral amyloidosis and loss of nerve cells
15816734|NCT04311515|Behavioral|Rating Scales|Alzheimer's Disease composite score (ADCOMS+), CDR sb, Alzheimer's Disease Assessment Scale Cognitive (ADAS cog), Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS ADL), Mini Mental State Examination (MMSE), Alzheimer's Disease Assessment Scale Cognitive (ADAS-COG 12)
15816735|NCT04311515|Drug|PU-AD|PU-AD 30mg daily for 6mos
15816736|NCT04311515|Drug|Placebo|Placebo 30mg daily for 6mos
15816737|NCT04311502|Drug|Clofazimine (CFZ)|Administered orally once daily
15816738|NCT04311502|Drug|Rifapentine (RPT)|Administered orally once daily
15816739|NCT04311502|Drug|Isoniazid (INH)|Administered orally once daily
15816740|NCT04311502|Drug|Pyrazinamide (PZA)|Administered based on weight orally once daily
15816741|NCT04311502|Drug|Ethambutol (EMB)|Administered based on weight orally once daily
15816742|NCT04311502|Drug|Rifampicin (RIF)|Administered orally once daily
15816743|NCT04311502|Dietary Supplement|Pyridoxine (vitamin B6)|All participants must receive pyridoxine (vitamin B6) with each dose of INH based on current local, national or international dosing guidelines. Pyridoxine is not provided by the study.
15816744|NCT04311489|Drug|Ularitide|Continuous intravenous infusion for 48 hours at a dose of 30 ng/kg/min. Depending on effect and/or side effects dose can be adjusted to 15 ng/kg/min or 45 ng/kg/min.
15816745|NCT04311489|Drug|Placebo|Continuous intravenous infusion for 48 hours at a bodyweight-adjusted infusion rate.
15816746|NCT04311476|Other|Autologous Umbilical Cord Blood Mononuclear Cells infusion Therapy|Evaluate Autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates
15816747|NCT04311476|Drug|0.9% Sodiun Chloride|0.9% Sodiun Chloride in control group
15816748|NCT04311463|Drug|Paroxetine hydrochloride|Paroxetine hydrochloride will be administered.
15816749|NCT04311463|Drug|PAXIL (Paroxetine hydrochloride )|PAXIL will be administered.
15816750|NCT04311450|Behavioral|Behavioral Weight Loss (BWL) counseling|This therapy is a weekly treatment which focuses on making gradual and modest lifestyle changes with goals of establishing regular patterns of eating, setting weekly goals, decreasing caloric intake, developing coping skills, and increasing physical activity.
15816751|NCT04311437|Procedure|Self-acupressure therapy|The self-acupressure therapy is as follows: Patients are in sitting position, applied firm pressure (3-5 kg of pressure) with the fingertips in a circular motion at a speed of two circles per second for a duration of one min per acupoint. A 1-2-s rest is applied after each ten circles. The complete process lasts for about 5 min.
15816752|NCT04311437|Procedure|Combined Valsalva and Toynbee maneuvers|Valsalva maneuver: blowing against a closed mouth and nostrils, increasing the middle ear pressure. Toynbee maneuver: swallowing while the mouth and nostrils are closed, decreasing the middle ear pressure.
15816753|NCT04311424|Drug|14C Tirzepatide|Administered SC.
15816754|NCT04311411|Drug|Tirzepatide|Administered SC.
15816755|NCT04311411|Drug|Placebo|Administered SC.
15816756|NCT04311411|Drug|Liraglutide|Administered SC.
15816757|NCT04311398|Diagnostic Test|New QIAstat-Dx fully automatic multiple PCR detection platform|We use the New QIAstat-Dx fully automatic multiple PCR detection platform to test the enrolled patients
15816758|NCT04311385|Diagnostic Test|CT imaging|CT scan reported as 1-2 pericolic bubbles, but no free distant bubbles in the abdomen or abscess.
15816759|NCT04311372|Behavioral|Educational Sesssion+Material+Videos|n =50 participants (Educational Session + Material from Educational Session (Handout form) + Access to Online Video Library)
15816760|NCT04311372|Behavioral|Educational Sesssion+Material ONLY|n =50 participants (Educational Session + Material from Educational Session (Handout form) ONLY)
15816761|NCT04311359|Drug|Drugs, Generic|All drugs having 19 or more Brain Oedema cases reported to the FAERS database
15816762|NCT04311346|Diagnostic Test|Cardiac MR|Cardiac MR diagnostic tool for detection of acute rejection, double blind comparison with invasive cardiac biopsy
15816763|NCT04311333|Diagnostic Test|Endostomal three-dimensional ultrasonography|Examination with rectal probe enclosed by water-filled balloon. Rectal mode. Dynamic examination in different positions with and without increased intra-abdominal pressure.
15816764|NCT04311333|Diagnostic Test|Computerized tomography of the abdomen|"Supine position, without increased intra-abdominal pressure. Experienced radiologist interprets the examination.
~If adequate examination has already been performed within the last 10 months, these images will be used and the patient will thus not undergo computerized tomography within the study."
15816765|NCT04311333|Diagnostic Test|Clinical examination|Patients will be clinically examined with inspection and palpation in supine and erect position with and without increased intra-abdominal pressure.
15816766|NCT04311333|Diagnostic Test|Evaluation at laparotomy/laparoscopy|During laparotomy or laparoscopy, inspection and/or palpation of the stoma at the abdominal wall orifice is performed.
15816798|NCT04311099|Procedure|Injection of placebo - Ultrasound-guided transverse abdominal plane block|Lateral ultrasound-guided transverse abdominal plane block with saline solution
15816799|NCT04311099|Procedure|Injection of placebo - Laparoscopic assisted transverse abdominal plane block|Laparoscopic assisted subcostal transverse abdominal plane block with saline solution
15816800|NCT04311086|Device|Renal Denervation (Symplicity Spyral™)|Device: Symplicity Spyral™ multi-electrode renal denervation system. After a renal angiography according to standard procedures, subjects are treated with the renal denervation procedure.
15816767|NCT04311320|Device|Low-Resource Oxygen Blender|The device that is being evaluated is a novel low-cost, high access oxygen blender designed to be used in the World Health Organization bCPAP design. It functions by utilizing the Venturi effect, whereby a narrow jet of one fluid (i.e. oxygen) creates a suction effect and entrains surrounding ambient fluid (i.e. room air) into the jet, effectively creating a mixed solution of both fluids. The cost of materials amounts to approximately 1.40 U.S.D. The average time it takes to build a blender and incorporate it into a bCPAP circuit for a new user is approximately 16 minutes. The materials can all be found in a standard hospital, namely 3cc syringes with rubber stops and a 22 gauge hypodermic needle.
15816768|NCT04311307|Biological|[6,6-2H2]glucose|Each subject will be administered two oral [6,6-2H2]glucose loads (pre-prandial, fed) in the hospital setting and one oral [6,6-2H2]glucose load at home setting (random time). Capillary blood samples will be collected on filter paper 10 times at specific time points after each oral [6,6-2H2]glucose load.
15816769|NCT04311294|Drug|ANS-6637 Low Dose|ANS-6647 is a selective, reversible, and orally bioavailable aldehyde dehydrogenase 2 (ALDH2) inhibitor. It will be tested at a low dose (200mg) and a high dose (600mg) against matched placebo.
15816770|NCT04311294|Drug|ANS-6637 High Dose|ANS-6647 is a selective, reversible, and orally bioavailable aldehyde dehydrogenase 2 (ALDH2) inhibitor. It will be tested at a low dose (200mg) and a high dose (600mg) against matched placebo.
15816771|NCT04311294|Drug|Matched Placebo|ANS-6647 is a selective, reversible, and orally bioavailable aldehyde dehydrogenase 2 (ALDH2) inhibitor. It will be tested at a low dose (200mg) and a high dose (600mg) against matched placebo.
15816772|NCT04311281|Biological|[F-18]FDDNP-PET|[F-18]FDDNP, or 2-(1-{6-[(2-[F-18]fluoroethyl)(methyl)amino]-2- naphthyl}ethylidene)malononitrile, is a positron emission tomography (PET) radiotracer developed for the in vivo visualization of tau and amyloid-beta (Aβ) deposition in the brain.
15816773|NCT04311268|Device|F2D armband|Comparison of the core temperature obtained during 24-48 h with eCelsius and with F2D armband in different life situations.
15816774|NCT04311255|Procedure|regional anesthesia for the upper limb|pecs-II block and intercostal nerve block
15816775|NCT04311242|Other|Diet|Ketogenic diet
15816776|NCT04311229|Device|Negative-Pressure Wound Therapy group|The wounds were initially evaluated for any necrotic findings and debrided if needed, and then washed with an antiseptic solution. 3-DWM was used to measure the pressure sores by taking pictures.The length and width of wounds were measured with disposable paper rulers. Wound depth was determined in centimeters with a sterile cotton-tip applicator by measuring against a ruler. The wound was closed using a Wound Care Kit that includes foam dressing, film drape, TRAC pad with tubing and a drainage canister. Foam material was placed inside the wound and was attached to the canister through tubing.The canister was attached to the Vacuum-Assisted Closure device, which is a portable device that applies intermittent or continuous negative pressure.The device was operated at 125 mmHg pressure for 5 minutes with and 2 minutes without active vacuum.Wound dressings were changed every 48 hours.Wound area was measured after all three rounds of treatment.
15816777|NCT04311229|Other|contol group|Wounds were finally covered with gauze dressing soaked with saline. Wounds were treated three times a day, and measurements were repeated every 48 hours. Every wound was measured a total of four times: one pre-treatment (baseline) and three post-treatment measurements.
15816778|NCT04311216|Other|3D movement analysis with surface electromyography|Single measurement session of 3D movement analysis with surface electromyography for upper limb movements
15816779|NCT04311203|Behavioral|Mental Health First Aid|The intervention has 3 parts:1.Two-day MHFA training provided by MHFA England. A manualised programme designed to provide individuals with: an in-depth understanding of mental health and the factors that can affect wellbeing, practical skills to spot triggers and signs of mental health issues, confidence to step in, reassure and support a person in distress, enhanced interpersonal skills such as non-judgemental listening, knowledge to help someone recover their health by guiding them to further support - whether that's self-help resources, through their employer, the NHS, or a mix. 2.Raising awareness of the presence of MHFA in the organisation. 3.The application of MHFA to participants in the workplace using the manualised five-stage approach, ALGEE: Approach the person, assess and assist with any crisis; Listen and communicate non-judgementally; Give support and information; Encourage the person to get appropriate professional help and Encourage them to seek other forms of support.
15816780|NCT04311190|Other|Family engagement|Physical exercises and simple care tasks
15816781|NCT04311177|Drug|Losartan|Losartan; 25 mg daily; oral administration
15816782|NCT04311177|Other|Placebo|Placebo (microcrystalline methylcellulose, gelatin capsule); oral administration
15816783|NCT04311164|Other|Questionnaire-based survey|The online questionnaire-based survey is composed of multiple items including pre-coded (multiple choice) questions, dichotomous (yes/no) questions, rating scales and validated questionnaire scales to measure general and diabetes/insulin pump-specific behavior, psychological concepts and preferences.
15816784|NCT04311164|Other|No intervention given.|No intervention was given.
15816785|NCT04311151|Procedure|own seizures visualization|At the hospital discharge, patients
15816786|NCT04311138|Other|community-based reablement service|Experimental group receive a 10-wk diversified community-based reablement service including group exercise, cognitive training, health education for 1.5 hours, and individualized reablement for 1.0 hour.
15816787|NCT04311138|Other|multicomponent training|control group receive a 10-wk multicomponent training including 1.5-hr group intervention (group exercise, cognitive training, and health education) and 1.0-hr placebo intervention.
15816788|NCT04311125|Procedure|Mini posterior approach Total Hip Replacement|Total hip replacement in patients suffering from hip osteoarthritis using the mini posterior approach
15816789|NCT04311125|Procedure|Anterior approach total hip replacement without a traction table|Mini Anterior approach total hip replacement in patients suffering from hip osteoarthritis without the aid of a traction table
15816790|NCT04311125|Procedure|Anterior approach total hip replacement with a traction table|Mini Anterior approach total hip replacement in patients suffering from hip osteoarthritis with the aid of a traction table
15816791|NCT04311112|Drug|Placebos|Placebo
15816792|NCT04311112|Drug|ZA Low dose|ZA low dose
15816793|NCT04311112|Drug|ZA high dose|ZA high dose
15816794|NCT04311099|Drug|Active drug|Injection of Ropivacaine
15816795|NCT04311099|Drug|Placebo|Injection of Saline solution
15816801|NCT04311073|Drug|Tranexamic Acid|IV Tranexamic acid in 50 ml will be given 15 minutes prior to initial surgical incision in the placebo group.
15816802|NCT04311073|Drug|Placebos|IV normal saline 50 ml will be given 15 minutes prior to initial surgical incision in the placebo group.
15816803|NCT04311060|Diagnostic Test|Molecular panel|"Detection of CBF rearrangements using PCR: CBFB-MYH11 [inv(16)(p13;q22), isoforms A, E and D; AML-ETO (RUNX1-RUNX1T1) (t8;21)(q22;q22).
~NGS panel to detect classic mutations in: FLT3-ITD and TKD, NPM1, CEBPA, RUNX1, TP53, ASXL1, IDH1, IDH2 and KIT"
15816804|NCT04311047|Diagnostic Test|USPIO-enhanced MRI|Administration of USPIO contrast 24-36 hours before MRI scan of the abdomen to detect lymph node metastases.
15816805|NCT04311034|Drug|RC48|Participants will be treated with RC48-ADC at a dose of 2.0 mg/kg, every 2 weeks. They will continue the medication until one of the following conditions occurred: disease progression, intolerance of toxicity, investigators believed that the subject could no longer benefit from treatment, or this study ended.
15816806|NCT04311021|Other|No intervention|No intervention
15816807|NCT04310995|Drug|Nicorandil|oral Nicorandil Tablets 5mg (5mg per tablet) three times daily
15816808|NCT04310995|Drug|Diltiazem Hydrochloride|oral Diltiazem Hydrochloride Sustained-release Tables180mg (90 mg per tablet) once daily
15816809|NCT04310995|Drug|Isosorbide Mononitrate 50 mg|oral Isosorbide Mononitrate Sustained-release Capsules 50 mg (50mg per capsule) once daily
15816810|NCT04310982|Device|The G-Walk sensor system (G-Walk)|The G-Walk is a wireless sensor device which is placed on an elastic belt and worn on the waist of the person being evaluated. The device is placed with the center of the device at the fifth lumbar vertebrae and the patient is completely free to walk, run and jump wearing this device. The gait and jump performance of the participants was assessed with the participants wearing this device two times to investigate the test-retest reliability. The second being 7 days after the first.
15816811|NCT04310969|Device|MiBoFlo Thermoflo|Each treatment for each eye takes 10 minutes and is treated every two weeks for a total of three times. The device was preheated to 42.2℃ and the eyelid was cleaned and smeared with a small amount of ultrasound gel in order to reduce friction between the device and eyelid skin. Then massage the outer skin of the upper and lower eyelids for a period of 10 minutes. The patient's eyes keep closed during therapy.
15816812|NCT04310969|Procedure|forceful expression of the meibomian glands|Utilize a cotton swab on the inner surface of the eyelid and the another cotton swab on the outer lid to apply force
15816813|NCT04310969|Device|LipiFlow|LipiFlow treatment applies heat to the palpebral surface of eyelids while simultaneously applying graded pulsatile pressure to the outer eyelid surfaces, thereby expressing the meibomian glands during heating.
15816814|NCT04310956|Device|Y-Knot all-suture anchor|Y-knot all-suture anchor will be implanted to participants
15816815|NCT04310956|Device|Biocomposite suture anchor|Biocomposite suture anchor will be implanted to participants
15816816|NCT04310943|Drug|Tislelizumab|Tislelizumab, 200mg, Q3W ,use until disease progression
15816817|NCT04310930|Drug|Amikacin|Adults: Intravenous amikacin 5mg/kg once daily or 7.5mg/kg twice daily or 20-25 mg/kg thrice weekly. Children:Intravenous amikacin 15-30 mg/kg once daily, maximum dose 1500mg
15816818|NCT04310930|Drug|Tigecycline|Adults: Intravenous Tigecycline 25 mg increasing by 5 mg every two doses until either maximum dose reached (50mg) or until patient is unable to tolerate twice daily. Children (≥8 years of age) intravenous tigecycline: Day 1- 0.6mg/kg twice daily to a maximum of 25mg. Day 2- 0.6mg/kg (maximum 25mg) in the morning, 1.2 mg/kg (maximum 50mg) at night. Day 3- 1.2mg/kg (maximum 50 mg) twice daily
15816819|NCT04310930|Drug|Imipenem|Adults: Intravenous Imipenem (≥50kg) 500mg twice daily (<50kg) 15 mg/kg twice daily. Children: intravenous imipenem Day 1- 2- 25mg/kg (maximum 1g) twice daily. DAY 3- 25mg/kg (maximum 1g) four times daily (drop to 3 if not tolerated).
15816820|NCT04310930|Drug|Cefoxitin|Adults: If imipenem is poorly tolerated intravenous cefoxitin 200 mg/kg thrice daily. Children: if imipenem is poorly tolerated intravenous cefoxitin 50mg/kg (maximum 4g) four times daily.
15816821|NCT04310930|Drug|Azithromycin|"Adults: Oral azithromycin 500mg (≥40kg) once daily, (<40kg) 250mg once daily.During consolidaiton: 500mg (≥40kg) thrice weekly, (<40kg) 250mg thrice weekly.
~Children: Oral azithromycin:10mg/kg (maximum 500mg) once daily. During consolidation 10mg/kg once daily maximum 500mg."
15816822|NCT04310930|Drug|Clarithromycin|Adult: If azithromycin is poorly tolerated use oral clarithromycin 500mg twice daily.Children: If azithromycin is poorly tolerated use oral clarithromycin. In children 1 month old- 11years of age the following dosing applies: <8kg: 7.5mg/kg twice daily, maximum dose 62.5mg, 8-11kg: 62.5mg twice daily, maximum dose 62.5mg, 12-19 kg: 125mg twice daily, maximum dose 125mg, 20-29 kg: 187.5mg twice daily, maximum dose 187.5mg, 30-40 kg: 250mg twice daily, maximum dose 250mg, Children 12-18 years of age: 500 mg twice daily
15816823|NCT04310930|Drug|Clofazimine|Adult: Oral clofazimine 100mg once daily. Children: Oral clofazimine: 3-5mg/kg once daily. Maximum dose of 50mg once daily if <40kg or 100mg if ≥40kg once daily.
15816824|NCT04310930|Drug|Ethambutol|Adults: with confirmed mixed NTM infections (slow growers + MABS) oral ethambutol can be added at either 15 mg/kg once daily or 25mg/kg thrice weekly. Children with confirmed mixed NTM infections (slow growers + MABS) oral ethambutol can be added at 20 mg/kg once daily.
15816825|NCT04310930|Drug|Amikacin|adult: Inhaled amikacin 500mg twice daily. Children: Inhaled amikacin 500mg twice daily
15816826|NCT04310930|Drug|Linezolid|"Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral linezolid 600mg once daily.
~Children: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin or rifabutin) guided by participant susceptibility and tolerance. Age 1 week - 9 years 10mg/kg twice daily maximum dose of 300mg. Age 10-12 years 10mg/kg twice daily maximum dose of 600mg. >12 years 600mg once daily."
15816827|NCT04310930|Drug|co-trimoxazole|Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral Co-trimoxazole (TMP-SMX) 160/800mg twice daily. Children: During consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin or rifabutin) guided by participant susceptibility and tolerance. Oral co-trimoxazole 5mg TMP/kg maximum dose of 160mg TMP/ 800mg SMX twice daily.
15816922|NCT04310176|Drug|Capecitabine|Maintenance treatment (both arms): 1250 mg/m2 twice daily on days 1 to 14, every 3 weeks or 1250 mg/m2 twice daily on days 1 to 10, every 2 weeks
15816828|NCT04310930|Drug|Doxycycline|Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral doxycycline 100mg once daily. Children: During consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin or rifabutin) guided by participant susceptibility and tolerance. Oral doxycycline (ages ≥ 8 years) 2mg/kg once daily maximum dose 100mg.
15816829|NCT04310930|Drug|Moxifloxacin|Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral moxifloxacin 400mg once daily. Children: During consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin or rifabutin) guided by participant susceptibility and tolerance. Oral moxifloxacin 10-15mg/kg once daily, maximum dose 400mg
15816830|NCT04310930|Drug|Bedaquiline|Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral bedaquiline (18-64 years of age) 400mg once daily for the first two weeks followed by 400mg thrice weekly for 22 weeks (maximum duration of 6 months).
15816831|NCT04310930|Drug|Rifabutin|Adult: during consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin, bedaquiline or rifabutin) guided by participant susceptibility and tolerance. Oral rifabutin: 5mg/kg once daily, maximum 300-450mg. Children: During consolidation in combination with one to three oral antibiotics (co-trimoxazole, doxycycline, moxifloxacin or rifabutin) guided by participant susceptibility and tolerance. Oral rifabutin 5mg/kg once daily
15816832|NCT04310917|Other|blood lipoprotein (a) test|research specific blood sample
15816833|NCT04310904|Other|contrast assessment of cardiac output (CO)|Patients hospitalized in ICU will be included if they need a trans esophageal echocardiographic evaluation and a research of intra cardiac shunt (using a saline contrast test). Patients with Swan Ganz catheter will be included as well. Cardiac output will be measured using cardiac Doppler. Simultaneously, 4.5 ml of saline with 0.5 ml of air will be agitated to have a contrast solution. This solution will be injected as usual and echocardiographic imaging will be recorded. These imaging will be analyzed off-line and CO will be calculated with an algorithm previously developed and compared with the reference method. In case of swan ganz catheter, the cardiac output will be also measured using the thermodilution technique.
15816834|NCT04310904|Other|cardiac Doppler technique|Patients hospitalized in ICU will be included if they need a trans esophageal echocardiographic evaluation and a research of intra cardiac shunt (using a saline contrast test). Patients with Swan Ganz catheter will be included as well. Cardiac output will be measured using cardiac Doppler. Simultaneously, 4.5 ml of saline with 0.5 ml of air will be agitated to have a contrast solution. This solution will be injected as usual and echocardiographic imaging will be recorded. These imaging will be analyzed off-line and CO will be calculated with an algorithm previously developed and compared with the reference method. In case of swan ganz catheter, the cardiac output will be also measured using the thermodilution technique.
15816835|NCT04310891|Radiation|Markerless Tumour Tracking|Intrafraction Kolovoltage X-ray Imaging using Fiducials
15816836|NCT04310878|Other|Survey among perioperative nurses and surgeons|Online survey
15816837|NCT04310865|Drug|Yinhu Qingwen Granula|"Yinhu Qingwen Granula is a kind of herbal granula made from Yinhu Qingwen Decoction, which consits of 11 Chinese herbal medicine as Honeysuckle, Polygonum cuspidatum, Schizonepeta, Longspur epimedium, etc. The granula will be dissolved into 600ml decoction and divided to 3 times (once with 200ml). It will be given a 200ml per time, three times a day, for 10 days."
15816838|NCT04310865|Drug|Yin Hu Qing Wen Granula(low does)|This intervention is given as 10% dose of YinHu QingWen Granula.The granula will be dissolved into 600ml decoction and divided to 3 times (once with 200ml).
15816839|NCT04310865|Other|standard medical treatment|Standard medical treatment is adhered to the protocol of the treatment for the severe CoVID-19 according to the guideline approved by National Health Commission of China.
15816840|NCT04310852|Device|BioCue Concentration Kit|The treatment will be carried out in the operating room under ordinary hospitalization and involves the application of 9 ml of autologous bone marrow concentrate in the knee affected by arthrosis. Specifically, 3 ml will be applied at the level of the bone-cartilage interface of the femur, 3 ml at the level of the bone-cartilage interface of the tibia, and 3 ml will be injected into the joint for a simultaneous action also at the level of the cartilage. To obtain the necessary amount of bone marrow concentrate, an aspirate of bone marrow will be taken from the iliac crest (60 ml) and homolateral tibia (30 ml) of the patient and concentrated by BioCue Concentration Kit, company Zimmer biomet, and centrifuge. This autologous bone marrow concentrate will be injected by means of the Perfuse at the level of the tibial and femoral bone-cartilage interface of the percutaneous arthrosis affected compartment under radiographic control.
15816841|NCT04310839|Procedure|Colectomy|colectomy due to neoplastic (stage 1) or diverticulosis
15816842|NCT04310826|Dietary Supplement|Dietary Intervention|Receive dietary magnesium intervention
15816843|NCT04310826|Other|Media Intervention|Undergo video interviews
15816844|NCT04310826|Behavioral|Telephone-Based Intervention|Receive phone calls
15816845|NCT04310813|Diagnostic Test|Multimodal spectroscopic analysis|During time of bladder or prostate resection, freshly excised cold cup biopsies of both bladder cancer or healthy bladder mucosa were taken and sent for inspection through label-free multimodal fiber optic spectroscopy (MFOS) within 30 minutes
15816846|NCT04310800|Procedure|LIFT-plug technique|Small-intestine submucosa extracellular matrix plug was soaked in saline for 5-10 min, then placed into the intersphincteric groove and pulled through the curetted tract to the external opening. The plug was secured with a figure-of-eight 3/0 absorbable suture to the fistula opening in the external sphincter and ligated. Excess plug protruding from the external opening was trimmed flush with the skin without fixation. The wound was loosely closed with 2-3 interrupted 3/0 absorbable sutures
15816847|NCT04310774|Drug|Tegafur, Gimeracil and Oteracil Potassium Capsules (one drug)|CCRT followed by Tegafur, Gimeracil and Oteracil Potassium Capsules consolidation chemotherapy
15816848|NCT04310761|Procedure|one single blastocyst transfer, both fresh and warmed|Ultrasound guided transvaginal embryo transfer.
15816893|NCT04310345|Behavioral|Animal-Assisted Interactions|Child and caregivers will spend approximately 10-5 minutes with a registered canine and its owner during potentially anxiety-producing visits to the clinic or hospital.
15816849|NCT04310748|Drug|Total Intravenous Anesthesia(TIVA)|"Ventilation of the patients was provided with a mixture of 40% oxygen and 60% air. Along with induction, propofol at a dose of 6-10 mg/kg/hour and remifentanil infusion at a dose of 0.3-0.4 mcg/kg/min were started for the maintenance of anesthesia. Drug concentrations were adjusted to maintain BIS values between 40-60 in the maintenance of anesthesia.
~The MAP target was determined to be in the range of 50-65 mmHg. Blood was collected and stored to measure TAS, TOS, Catalase, Myeloperoxidase, Total Thiol, Native Thiol and Disulfide parameters before and after induction at 5,30,60 and 120 minutes. Hemodynamic data (HR, SBP, DBP, MAP, SpO2) and BIS values of the patients were recorded at 5-minute intervals. The extubation time was recorded. The surgical field opinion and satisfaction assessment were made by Boezaart Scoring and the survey presented to the surgeon, respectively. The patients were followed up for 30 minutes; numerical pain scores and nausea-vomiting scores were recorded"
15816850|NCT04310748|Drug|Inhalation Anesthesia|"Ventilation of the patients was provided with a mixture of 40% oxygen and 60% N2O. As soon as mechanical ventilation started, sevoflurane was opened at a concentration of 2-3% with a MAK value of 1.1-1.3. Drug concentrations were adjusted to maintain BIS values between 40-60 in the maintenance of anesthesia.
~The MAP target was determined to be in the range of 50-65 mmHg. Blood was collected and stored to measure TAS, TOS, Catalase, Myeloperoxidase, Total Thiol, Native Thiol and Disulfide parameters before and after induction at 5,30,60 and 120 minutes. Hemodynamic data (HR, SBP, DBP, MAP, SpO2) and BIS values of the patients were recorded at 5-minute intervals. The extubation time was recorded. At the end of the surgery, the surgical field opinion and satisfaction assessment were made by Boezaart Scoring and the survey presented to the surgeon, respectively. The patients were followed up for 30 minutes; numerical pain scores and nausea-vomiting scores were recorded."
15816851|NCT04310735|Behavioral|Verbal smoking expectancy manipulation|Instructions regarding whether or not participants will have an opportunity to smoke during the experimental session.
15816852|NCT04310722|Other|None intervention. This is an observational study.|None intervention. This is an observational study.
15816853|NCT04310709|Drug|Regorafenib/Nivolumab|Combination of regorafenib and nivolumab
15816854|NCT04310696|Other|Buteyko Breathing exercises|Buteyko breathing technique was performed by asking the patient to take a small breath in and then out and hold his/her breath and count the time in seconds, as long as he or she can, until first signs of air hunger start to appear, followed by normal breathing once again. This procedure was repeated 15 times, three sets of 15 repetitions were given to the patient per day, 3 days per week and the treatment was continued for 4 weeks.
15816855|NCT04310696|Other|Pursed lip breathing|Pursed lip breathing was performed as nasal inspiration followed by expiratory blowing against partially closed lips. Participants received a total of 3 sets of 15 repetitions per day, 3 times a week and the treatment was continued for 4 weeks.
15816856|NCT04310683|Other|natural cycle for endometrium preparation|patients will not use oral contraceptive drugs
15816857|NCT04310683|Other|hormone replaced cycle for endometrium preparation|patients will receive oral contraceptive drugs for menstruation before embryo transfer
15816858|NCT04310670|Behavioral|Psychotherapy, Physiotherapy|"The 12-week program aims to improve patients' motor symptoms, gain insight into disease mechanisms, regain control over abnormal movements, and learn better coping strategies.
~All members of the therapy team will be consistent in planning communication and treatment goals.
~Physiotherapy treatment will be articulated through the use of techniques designed to qualify the functionality of the subject divided by symptom: weakness, dystonic attitudes of the limbs, walking disorders, tremor.
~From a psychological point of view, the patient will be treated according to Lacanian psychoanalytic ethics, which allows to adequately respond to the patient's request for healing but who at the same time does not ignore the progress of scientific research in the neurological field.
~Furthermore, diversified transcranial electrical stimulation protocols may be applied for therapeutic purposes."
15816859|NCT04310657|Diagnostic Test|mNGS|Metagenomics second generation sequencing technology
15816860|NCT04310644|Other|No intervention planned, but all patients get our standart treatment|Patients are selected from clinical Routine and get our standart Treatment based on their disease
15816861|NCT04310631|Drug|Ranibizumab Injection|Ranibizumab Injection (0.5 mg/0.05 ml): Three monthly intravitreal injections
15816862|NCT04310618|Other|No intervention|No intervention
15816863|NCT04310605|Behavioral|CBT 1|CBT for tinnitus (Step 1) comprised: individual audiometric assessment, and counselling about hearing and tinnitus (1hr) with an audiologist; a one-off educational group session (a max 10 participants and partners) (2hrs); an assessment session with a psychologists (1 hr).
15816864|NCT04310605|Behavioral|CBT 2|Step 2 group sessions were 2 hrs long over a 12-week period. Two therapists (a psychologist and physiotherapist) were present at any one time for Step 2 sessions. Step 2 included: psycho-education; exposure therapy; mindfulness exercises; cognitive restructuring; attention redirecting techniques; stress reduction; and, relaxation techniques. Evening sessions were also provided for participants to attend with family or partners.
15816866|NCT04310579|Drug|Oxycodone and Midazolam|"In one period subjects receive oxycodone 10-15 mg immediate release (IR) and placebo IV 1x per day.
~In a second period (randomized cross-over), subjects receive midazolam 0.0375-0.075 mg/kg IV and oral placebo tablet 1x per day.
~In a third period (randomized cross-over), subjects receive oxycodone 10-15 mg IR tablet and 0.0375-0.075 mg/kg midazolam IV 1x per day.
~In a fourth period (randomized cross-over), subjects receive oral placebo tablet and placebo IV 1x per day."
15816867|NCT04310579|Drug|Oxycodone, Paroxetine, and Quetiapine|"In one period, subjects receive: oxycodone 10-15 mg IR tablet 1x per day and oral placebo 3x per day on Days 1 and 5; and oral placebo 3x per day on Days 2-4.
~In a second period (randomized cross-over), subjects receive: oxycodone 10-15 mg IR tablet 1x per day, paroxetine 40 mg tablet 1x per day, and oral placebo 1x per day on Days 1 and 5; and paroxetine 40 mg tablet 1x per day and oral placebo 2x per day on Days 2-4.
~In a third period (randomized cross-over), subjects receive: oxycodone 10-15 mg IR tablet 1x per day, quetiapine 50 mg tablet 2x per day, and oral placebo 1x per day on Day 1; quetiapine 100 mg (2x50 mg tablets) 2x per day and oral placebo 1x per day on Day 2; quetiapine 150 mg (3x50 mg tablets) 2x per day and oral placebo 1x per day on Day 3; quetiapine 200 mg (4x50 mg tablets) 2x per day and oral placebo 1x per day on Day 4; and quetiapine 200 mg (4x50 mg tablets) 1x per day and oral placebo 1x per day on Day 5."
15817147|NCT04308434|Other|CSD190601-27|Flavor variant CSD190601-27 of a 3.0% nicotine ENDS product
15816868|NCT04310553|Procedure|Irreversible electroporation|Patients with locally advanced pancreatic cancer diagnosed by cell / histopathology will receive nano knife treatment if the target lesion is not suitable for surgical resection or the target lesion is suitable for surgical resection but patients give up surgery and choose nano knife combined with chemotherapy. Patients who have not previously received first-line chemotherapy will receive systemic chemotherapy for 4-6 cycles of treatment. Imaging evaluation will be performed every 6-8 weeks (± 7 days) during chemotherapy.
15816869|NCT04310540|Drug|Ga-68 labeled PSMA-11|The PET scan related patient visit will last approximately 2 to 2.5 hours, including 30 minute nursing assessment, 45-60 minutes for PSMA uptake and 60 minutes for PET scan.
15816870|NCT04310540|Procedure|Possible liver biopsy for locoregional therapy group|for participants undergoing locoregional therapy (ablation or embolization) a biopsy will be obtained via Ultrasound Guidance at the time of therapy to minimize additional introduction of cannula to obtain the biopsy
15816871|NCT04310527|Drug|Enasidenib|Enasidenib
15816872|NCT04310514|Dietary Supplement|Fructose/glucose/xylitol/saccharose|"Intervention: rehydration with glucose solution. Glucose will be administered at a dose of 35 mg (500 ml of 7% solution) taken orally once, in the middle of soccer training session, at approximately 10.00 a.m.
~Intervention: rehydration with fructose solution. Fructose will be administered at a dose of 35 mg (500 ml of 7% solution) taken orally once, in the middle of soccer training session, at approximately 10.00 a.m.
~Intervention: rehydration with xylitol solution. Xylitol will be administered at a dose of 35 mg (500 ml of 7% solution) taken orally once, in the middle of soccer training session, at approximately 10.00 a.m.
~Intervention: rehydration with sucrose solution Saccharose will be administered at a dose of 35 mg (500 ml of 7% solution) taken orally once, in the middle of soccer training session, at approximately 10.00 a.m."
15816873|NCT04310488|Other|The Centre of excellence self-administered (CESAM) questionnaire items|Complete a self-administered questionnaire within two days of their museum visit.
15816874|NCT04310475|Other|Virtual reality assisted CBT|This study uses virtual reality technology to assist cognitive behavioural therapy for social difficulties in people with first episode psychosis.
15816875|NCT04310462|Other|New e-prescribing interface|The goal of this study is to conduct a pragmatic trial to assess the utility of a new e-prescribing (eRX) interface for prescriptions of hydroxychloroquine (HCQ). Through randomization of clinicians to the new interface, the investigators will measure the effectiveness of the system in reducing the number of individuals prescribed HCQ over current guidelines.
15816876|NCT04310449|Procedure|Connective tissue graft and customized healing abutment|Immediate implant placement without flap raising using standard implant system protocol preparation will take place. Connective tissue grafts from the hard palate will be placed at the implant sites in a supraperiosteal partial dissection prepared at the buccal aspect. Sutures will be used to stabilize the graft, followed by customized healing abutment. Flowable composite will be injected at the gingival margin level to adapt to the sandblasted abutment, taking the shape of the socket at the marginal gingiva. Buccal groove will be made after the polymerization of this material for easier application. The abutments will be removed for final configurations of the apical part mimicking the emergence profile of the extracted tooth and finishing with laboratory discs and burs. The custom healing screw will be screwed to the implant.
15816877|NCT04310449|Procedure|Bone graft and customized healing abutment|Tooth extraction and immediate implant placement as mentioned, followed by particulate bone grafts are packed in the gap between the implant and the buccal plate of bone till the crest of the alveolar bone, then will be covered by a customized healing abutment that will be done as mentioned before.
15816878|NCT04310449|Procedure|Bone graft and ovate pontic|The extraction will take place and then particulate bone graft will be placed in the socket and a fixed temporary ovate pontic (PMMA) extending 3mm inside the socket, with minimal occlusal contact (38), will be placed and cemented on the adjacent teeth
15816879|NCT04310436|Behavioral|Modifying saccades by looking down to naval.|Paragraphs from list Provided by Researcher. Participants to read out loud for 10 minutes twice per day for the five week period. On any word they anticipate / experience dysfluencies look quickly down to their naval to reset the lateral tongue position.
15816880|NCT04310436|Behavioral|Modifying saccades by looking in air.|Paragraphs from list provided by Researcher. Participants to read out loud for 10 minutes twice per day for the five week period. On any word they anticipate / experience dysfluencies look quickly up to reset the lateral tongue position.
15816883|NCT04310410|Combination Product|combined radiotherapy and MR-HIFU|Following standard EBRT (single or multiple fraction), patients will receive one MR-HIFU treatment with the Profound Sonalleve MR-HIFU device on the most painful of their bone metastases. This treatment will take place in a short time frame of 3 hours to maximum 4 days. Patients will be followed up until 4 weeks after treatment. During follow-up they will be phoned around day 3, 7, 14, 21 and 28 to retrieve pain scores, pain medication and (serious) adverse events. At day 3 the patient's experience with the combined treatment will also be inquired.
15816884|NCT04310397|Drug|Dabrafenib|Given PO
15816885|NCT04310397|Biological|Spartalizumab|Given IV
15816886|NCT04310397|Procedure|Therapeutic Conventional Surgery|Undergo surgery
15816887|NCT04310397|Drug|Trametinib|Given PO
15816888|NCT04310384|Device|ShuttleScope|Alternative intervention
15816889|NCT04310384|Device|MacIntosh Laryngoscope|Gold Standart
15816890|NCT04310371|Behavioral|3-month lifestyle intervention|"Adolescents from the intervention group will be enrolled at the obesity center for the whole school year (i.e., 10 months). The physical activity program consists of two training sessions (aerobic and resistance training) per week.
~There will be two measurement time: one at baseline (Day 0) and one at three months after the beginning of the lifestyle intervention (M3). The controls will be evaluated at baseline only."
15816891|NCT04310358|Other|4 short PLMs group 1|Participants will take the 4 short PLMs on the visual estimation of LVEF. They will also take a pretest, an immediate post-test and a remote post-test at 1 month. Test 1 (pre-test), Test 2 (immediate post-test), Test 1 (remote post-test)
15816892|NCT04310358|Other|4 short PLMs group 2|Participants will take the 4 short PLMs on the visual estimation of LVEF. They will also take a pretest, an immediate post-test and a remote post-test at 1 month. Test 2 (pre-test), Test 1 (immediate post-test), Test 2 (remote post-test)
15816894|NCT04310332|Drug|1L-PEG|"The drug is 1L-PEG plus ascorbic acid (Plenvu®). It will be administered either the day before colonoscopy, or half the day before and half the day of colonoscopy, or the day of colonoscopy.
~Patients are prescribed bowel prep according to local clinical practice and then all undergo colonoscopy. No standardized intervention on bowel prep is applied, as the design of the study is observational."
15816895|NCT04310332|Drug|4L-PEG|"The drug is 4L-PEG. It will be administered either the day before colonoscopy, or half the day before and half the day of colonoscopy, or the day of colonoscopy.
~Patients are prescribed bowel prep according to local clinical practice and then all undergo colonoscopy. No standardized intervention on bowel prep is applied, as the design of the study is observational."
15816896|NCT04310319|Dietary Supplement|Sodiumchloride|Subjects will receive 4 capsules containting 750 NaCl each 2dd, making a total of 6 grams NaCl per day.
15816897|NCT04310319|Dietary Supplement|Protein|Subjects will receive 2dd 40 ml of a protein beverage containing 0.5 grams of protein per ml, making a total of 40 grams of protein per day.
15816898|NCT04310319|Dietary Supplement|Placebo comparator (salt)|Subjects will receive 4 placebo capsules (identical to salt capsules) 2dd.
15816899|NCT04310319|Dietary Supplement|Placebo comparator (protein)|Subjects will receive 2dd 40 ml of placebo beverage (identical to protein beverage).
15816900|NCT04310306|Device|Thrombectomy using EmboTrap II|The subjects will receive endovascular treatment for acute stroke according to standard clinical practice. Specifically, using a stent retriever, contact aspiration EmboTrap II. The number of thrombectomy attempts is at the operator's discretion. Combination of balloon guide catheter or intermediate catheter is recommended.
15816901|NCT04310293|Other|Femara,Grotwth hormone,HMG|NOVEL THERAPY
15816902|NCT04310280|Drug|Insulin Glargine|Half of the wound surface is injected daily with topical glargine insulin
15816903|NCT04310280|Drug|Saline|Half of the wound surface is injected daily with topical saline solution
15816904|NCT04310267|Device|Petit typeface mask|(Intraoral) Hyrax expander for maxilary sutures disarticulation through expansion, (Extraoral) Face mask for generating maxillary protraction forces and head gear face-bow to act as a connector between both intra and extra oral parts.
15816905|NCT04310254|Procedure|EDTA and CHX Solution|The teeth in this group were treated according to the guidelines for root canal treatment in single-session. The filling was removed and cavity was opened. After standart irrigation protocol, root canals were irrigated with Qmix 2in1 solution and obturated with gutta percha. Coronal restoration was complete using composite and/or fully crown if necessary.
15816906|NCT04310254|Procedure|EDTA Solution|The teeth in this group were treated according to the guidelines for root canal treatment in single-session. The filling was removed and cavity was opened. After standart irrigation protocol, root canals were irrigated with EDTA solution and obturated with gutta percha. Coronal restoration was complete using composite and/or fully crown if necessary.
15816907|NCT04310254|Procedure|CHX Solution|The teeth in this group were treated according to the guidelines for root canal treatment in single-session. The filling was removed and cavity was opened. After standart irrigation protocol, root canals were irrigated with CHX solution and obturated with gutta percha. Coronal restoration was complete using composite and/or fully crown if necessary.
15816908|NCT04310241|Behavioral|Patching therapy, Glasses|Patching, glasses and strabismus surgery are commonly employed measures in treatment of amblyopia and strabismus.
15816909|NCT04310228|Drug|Favipiravir Combined With Tocilizumab|"Favipiravir: On the 1st day, 1600mg each time, twice a day; from the 2nd to the 7th day, 600mg each time, twice a day. Oral administration, the maximum number of days taken is not more than 7 days.
~Tocilizumab:The first dose is 4 ~ 8mg/kg and the recommended dose is 400mg. For fever patients, an additional application (the same dose as before) is given if there is still fever within 24 hours after the first dose and the interval between two medications ≥ 12 hours.Intravenous infusion, The maximum of cumulative number is two, and the maximum single dose does not exceed 800mg."
15816910|NCT04310228|Drug|Favipiravir|On the 1st day, 1600mg each time, twice a day; from the 2nd to the 7th day, 600mg each time, twice a day. Oral administration, the maximum number of days taken is not more than 7 days.
15816911|NCT04310228|Drug|Tocilizumab|The first dose is 4 ~ 8mg/kg and the recommended dose is 400mg. For fever patients, an additional application (the same dose as before) is given if there is still fever within 24 hours after the first dose and the interval between two medications ≥ 12 hours.Intravenous infusion, The maximum of cumulative number is two, and the maximum single dose does not exceed 800mg.
15816912|NCT04310215|Biological|CARTISTEM®|"*Stratified randomization by lesion size below 1.5㎠ or more than 1.5㎠
~Procedure: Microfracture
~Biological: CARTISTEM®(Human Umbilical Cord Blood-derived Mesenchymal Stem Cell product)"
15816913|NCT04310215|Procedure|Microfracture|"*Stratified randomization by lesion size below 1.5㎠ or more than 1.5㎠
~1. Procedure: Microfracture"
15816914|NCT04310202|Other|Abbreviated Profile of Hearing Aid Benefit (APHAB)|An intervention in this study which is outside the routine clinical practice of the clinics is the APHAB questionnaire that will be completed by the subjects on two occasions.
15816915|NCT04310202|Other|Glasgow Benefit Inventory (GBI)|An intervention in this study which is outside the routine clinical practice of the clinics is the GBI questionnaire that will be completed by the subjects on two occasions.
15816916|NCT04310202|Other|Additional follow-up visits after surgery|There are 1-2 additional follow-up visits after surgery (compared to the routine clinical practice of the surgeons/clinics).
15816917|NCT04310189|Procedure|Biopsy|All patients will have a blood sample and 2 skin biopsies (2 mm diameter) in lesional and non lesional area
15816918|NCT04310176|Drug|Bevacizumab|5 mg/m2 as 20-to-30 minute intravenous (i.v.) infusion every two weeks. Maintenance treatment (both arms): 5 mg/m2 every 2 weeks (in combination with 5-Fluorouracil) or 7.5 mg/m2 every 3 weeks (in combination with capecitabine)
15816919|NCT04310176|Drug|mFOLFOX6 regimen|Oxaliplatin 85 mg/m2 as 2-3 hours i.v. infusion on day 1 followed by levo-folinic acid 200 mg/m2 as 1- 2 hours i.v. infusion followed by i.v bolus. 5-fluorouracil 400 mg/m2, and a 46-hour i.v. infusion of 5-fluorouracil 2400 mg/m2 every two week
15816920|NCT04310176|Drug|mOXXEL regimen|Oxaliplatin 85 mg/m2 as 2-3 hours i.v. infusion on day 1 plus oral capecitabine 1000 mg/m2 twice daily on days 1 to 10, every 2 weeks
15816921|NCT04310176|Drug|Valproic acid|given orally from 500mg-1500mg daily and an intra-patient titration for a target serum level of 50-100µg/ml
15816966|NCT04309812|Device|transcranial direct current stimulation (tDCS)|Electrical stimulation of scalp over a seizure focus
15816923|NCT04310176|Drug|5-fluorouracil|Maintenance treatment (both arms): Levo-folinic acid 200 mg/m2 as 1- 2 hours i.v. infusion followed by i.v bolus. 5-fluorouracil 400 mg/m2, and a 46-hour i.v. infusion of 5-fluorouracil 2400 mg/m2 every two weeks
15816924|NCT04310163|Other|Natural history|Parent interview and video capture
15816925|NCT04310150|Drug|Collastat|hemostatic agent that combine porcine-derived collagen thrombin
15816926|NCT04310150|Device|Floseal|hemostatic agent that combine bovine-derived gelatin
15816928|NCT04310111|Procedure|EUS-RFA|Use EUS-RFA to treat unresectable pancreatic cancer
15816929|NCT04310085|Drug|Artemether-Lumefantrine 20 Mg-120 Mg Oral Tablet|artemether-lumefantrine 6 x of 4 tablets at approximately 0, 8, 24, 36, 48 and 60 h
15816930|NCT04310085|Biological|PfSPZ-DVI Challenge|3200 P. falciparum Sporozoites by direct venous inoculation (DVI)
15816931|NCT04310072|Device|Neuromuscular electrical stimulation|NMES therapy induces visible rhythmic and repeated muscle contractions without volitional effort from the patient by applying electrodes to the thigh and/or calf muscles.
15816932|NCT04310059|Dietary Supplement|Folic acid|women will be randomised into one of the three groups. Group A - Folic acid 5mg/day Group B - Folic acid 0.5mg/day Group C - Materna one tablet/day (a pregnancy supplement containing 0.6mg folic acid)
15816933|NCT04310059|Dietary Supplement|Materna|Materna
15816934|NCT04310046|Procedure|PCI before TAVI|TAVI is performed using the Edwards SAPIEN Transcatheter Heart Valve®. PCI is performed in any suitable lesion with iwFR≤0.89 or >90% diameter stenosis on coronary angiography in a coronary artery ≥2.5 mm in diameter.
15816935|NCT04310046|Procedure|PCI after TAVI|TAVI is performed using the Edwards SAPIEN Transcatheter Heart Valve®. PCI is performed in any suitable lesion with iwFR≤0.89 or >90% diameter stenosis on coronary angiography in a coronary artery ≥2.5 mm in diameter.
15816936|NCT04310033|Other|Questionnaires|Quality of life questionary: 36-Item Short Form Survey Instrument (36-SF) at 3 and 6 months from inclusion By phone
15816946|NCT04309994|Other|Myocardial protection system (MPS)|cardioplegia solution, A separate pumpsystem by which Blood cardioplegia with individually composable additives as cardioplegia solution can be used
15816947|NCT04309994|Other|Cardioplexol|cardioplegia solution
15816948|NCT04309981|Biological|Adult differentiated autologous T-cells with anti-BCMA specificity|After pretreatment, adult differentiated autologous T-cells with a chimeric antigen receptor with anti-BCMA specificity will be transfused.
15816949|NCT04309968|Drug|Drug: SYHA1801|Drug: SYHA1801 administered orally
15816950|NCT04309955|Procedure|pigtail catheter|After inserting the chest tube, add a pigtail catheter into the posterior axillary lines of the 7th intercostal.
15816951|NCT04309942|Other|Guided Clinical Pharmacy Consultation|These patients will have the benefit of a Guided Clinical Pharmacy Consultation
15816952|NCT04309929|Drug|Analgesics|All patients will undergo the anesthesiological and surgical treatment provided for the patient's clinical conditions and in no case will the patients undergo a change in the normal diagnostic-therapeutic path due to participation in this study.
15816953|NCT04309916|Drug|Tegoprazan|Tegoprazan 50mg tablet
15816954|NCT04309916|Drug|Esomeprazole|Esomeprazole 40mg tablet
15816955|NCT04309903|Other|Manual therapy|Both groups received for 3 sessions per week, a total of 5 weeks. Home exercises were performed by the patient for 30 minutes at home.In home exercises active ROM for warm-up (5 min), passive stretchening (5 min), strengthening exercises (10 min), proprioceptive and balance exercises (10 min). In manual therapy group, myofascial release techniques (MRT) and Kalternborn mobilization techniques lasted about one hour. In MRT, each manuever was applied for 2 mins and 3 times. The superficial strokes were performed, assisted by slight movements of joints. MRT to posterior capsule of the knee, ligaments, iliotibial tractus, plantar fascia, metatarsal, tarsals, and toes. Kalterborb mobilization tecnqiues; posterior gliding for restricted knee flexion, anterior gliding for restricted knee extension,talocrural posteior gliding for dorsal flexion, talocrural anterior gliding for plantar flexion.3 * 10 repetitions, 20 sec of per reps and 10 sec of interval.
15816956|NCT04309890|Other|Arabic version of the Overactive Bladder Symptom Score Questionnaire|All enrolled patients were asked to complete the Arabic OABSS questionnaire in its final edition before and three months after treatment with Solfinasin 5 mg once daily
15816957|NCT04309877|Drug|Theophylline ER|Capsules of theophylline ER
15816958|NCT04309877|Other|PO placebo|Capsules of methylcellulose
15816959|NCT04309877|Biological|Lipopolysaccharide (LPS)|Purified bacterial wall component as an inflammatory challenge
15816960|NCT04309877|Other|IV placebo|Normal (0.9%) saline
15816961|NCT04309864|Device|Use of CMAP app for education (in-hospital)|Clinicians will use the updated CMAP system during patient education for prevention of pressure injuries with Veterans with SCI who are completing their initial rehabilitation.
15816962|NCT04309864|Device|Use of CMAP app (in-home)|The Veteran will use the CMAP system at home for two weeks during their daily routines.
15816963|NCT04309851|Diagnostic Test|deep learning|the deep learning method is a field of study involving artificial neural networks and similar machine learning algorithms with many hidden layers.
15816964|NCT04309838|Combination Product|Treprostinil via implanted pump|Patients, diagnosed with PAH classified in stagnating intermediate-risk status after triple therapy including Selexipag for at least three months will receive the implantation of LENUS pro that enables permanent infusion of Treprostinil.
15816965|NCT04309825|Procedure|transgastrostomal endoscopy|Placement the endoscope through the g-tube port and not through the mouth of a patient undergoing an upper gi endoscopy
15816968|NCT04309773|Drug|Bezafibrate (400mg) in addition to standard 15-20 mg/kg/jour UDCA therapy|Bezafibrate (400mg) in addition to standard 15-20 mg/kg/jour UDCA therapy Treatment duration : 24 months Bezafibrate/AUDC : daily oral dose
15816969|NCT04309773|Drug|Placebo of Bezafibrate in addition to standard UDCA therapy|Placebo of Bezafibrate (400mg) in addition to standard 15-20 mg/kg/Day UDCA therapy Treatment duration : 24 months Placebo/AUDC : daily oral dose
15816970|NCT04309760|Other|MRI|Subjects will receive structural and functional (resting state) MRI
15816971|NCT04309747|Procedure|nanosecond knife liver cancer ablation|This trial is a prospective, multi-center, single-arm clinical trial. Four hospitals with national medical clinical trial institution qualifications are selected as clinical trial centers. Qualified participants will receive nanosecond pulse ablation therapy according to the routine procedures. The results will be recorded according to the requirements of the primary and secondary efficacy indicators. After then, statistical comparisons of effectiveness and safety of the product will be made according to groups.
15816972|NCT04309734|Drug|AT-777|Administered orally as one or two 60 mg capsule(s) of AT-777 (inhibitor of HCV nonstructural protein 5A (NS5A)), depending on the arm.
15816973|NCT04309734|Drug|Placebo|Administered orally, as one or two placebo capsules, depending on the arm.
15816974|NCT04309734|Drug|AT-527|Administered orally as one 550 mg tablet of AT-527 (nucleotide prodrug inhibitor of HCV nonstructural protein 5B (NS5B) polymerase), depending on the arm.
15816975|NCT04309721|Drug|Perampanel|Single-dose of Perampanel 12 mg film-coated tablet, will be given orally in patients with status epilepticus that do not involve the oral and pharyngeal musculatures. In alternative, perampanel will be administered by a nasogastric feeding tube, a procedure which has been recently reported to be safe and tolerated in patients with generalised status epilepticus
15816976|NCT04309721|Drug|Placebo|Single-dose of placebo of Perampanel, administered orally. Placebo of perampanel will be given orally, in patients with status epilepticus that do not involve the oral and pharyngeal musculatures. In alternative, Placebo of perampanel will be administered by a nasogastric feeding tube, a procedure which has been recently reported to be safe and tolerated in patients with generalised status epilepticus
15816977|NCT04309708|Device|Nimodipine pump infusion|Patients with nimodipine pump infusion with pump infusion line and other infusion equipments
15816978|NCT04309695|Device|Zenflow Spring System|The Zenflow Spring is a nitinol urethral implant for the treatment of Lower Urinary Tract Symptoms (LUTS) that arise due to bladder outlet obstruction (BOO), secondary to the presence of Benign Prostatic Hypertrophy (BPH). The device is intended to be a permanent implant however it may be removed if necessary.
15816979|NCT04309682|Procedure|crestal sinus approach technique|a Full thickness flap will be elevated at the edentulous site with two vertical releasing incision and then the preparation of osteotomy will be prepared following standard implant system protocol preparation of the osteotomy. Drilling will be done gently till reaching 0-1mm from the sinus floor, then implant placement will take place and the implant itself will be used to gently elevate the sinus up to 3-5mm.
15816980|NCT04309682|Procedure|Lateral sinus approach|a full-thickness flap will be elevated at the edentulous site with two vertical releasing incisions extending to the vestibule for better reflection and exposure to the lateral wall of the sinus. The lateral antrostomy will be prepared in the lateral sinus wall using rotary bur no. 8 to provide adequate access to remove the thin to thick cortical bone and to expose the thin sinus membrane. The membrane will be elevated across the sinus floor and up the medial wall and this elevation must extend anteriorly-posteriorly to provide the exposed sinus floor. Drilling will be done gently till reaching 0-1mm from the sinus floor, then implant placement will take place
15816981|NCT04309669|Drug|TOT'HEMA|three ampoules per day during 12 weeks
15816982|NCT04309656|Drug|Pretomanid|"Treatment A (reference) = 200 mg given as a single 200 mg tablet (using the immediate release formulation), orally administered.
~Treatment B (test) = 200 mg given as four 50-mg tablets (using the dispersible pediatric formulation), orally administered.
~Treatment C (test) = single 50-mg dispersible tablet, orally administered.
~Treatment D (test) = single 10-mg dispersible tablet, orally administered."
15816983|NCT04309643|Drug|CTP-543|Investigational Drug
15816984|NCT04309643|Drug|Combined oral contraceptive containing Ethinyl estradiol (EE) and Levonorgestrel (LNG)|Oral contraceptive in the form of 1 fixed combination tablet of Seasonique or generic equivalent (0.03 mg EE / 0.15 mg LNG)
15816985|NCT04309630|Procedure|intercostal block|pain control by intercostal block
15816986|NCT04309630|Procedure|erector spina plane block|pain control by erector spina plane block
15816987|NCT04309617|Procedure|nephrectomy|Surgery performed within the study period
15816988|NCT04309604|Biological|IC14|monoclonal antibody directed against CD14
15816989|NCT04309591|Device|CytoSorb haemoadsorption (HA) device|CytoSorb® cartridges contain biocompatible sorbent polystyrene divinylbenzene beads coated with polyvinylpyrrolidone, capable of removing inflammatory molecules (eg Interleukin). The cartridge is inserted in a cardio-pulmonary bypass circuit to remove inflammatory molecules during cardiac surgery .
15816990|NCT04309578|Drug|Trastuzumab, Capecitabine and Cisplatin|"Trastuzumab intravenous administration at a loading dose of 8 mg/kg on day 1 followed by 6 mg/kg every 3 weeks
~Capecitabine oral administration at a dose of 1000 mg/m2 twice daily for 14 days every 3 weeks (from evening on day 1 to morning on day 15)
~Cisplatin intravenous administration at a dose of 80 mg/m2 on day 1"
15816991|NCT04309565|Behavioral|Transitions Clinic Network Primary Care|Transitions Clinic Network (TCN)- participants in this arm will be referred to a TCN program for primary care and community Opioid Treatment Program (OTP). All TCN programs have the ability to prescribe buprenorphine and Extended-release naltrexone (XR-NTX) and assist with referrals to methadone. The primary features of the TCN include (1) primary care and onsite MOUD or referral to community treatment when indicated, (2) addressing social determinants of OUD and care coordination through a Community Health Worker (CHW), and (3) addressing the discrimination and stigma that exist based on incarceration.
15816992|NCT04309565|Behavioral|Standard Primary Care|Those randomized to the standard primary care arm will be referred to primary care and community Opioid Treatment Program (OTP). Participants may receive buprenorphine or Extended-release naltrexone (XR-NTX) through primary care or with a community addiction treatment provider.
15817014|NCT04309383|Diagnostic Test|ShuntCheck|The intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow.
15817148|NCT04308421|Device|Red light|Low irradiation 650 nm +/- 5 nm red light
15816993|NCT04309552|Drug|18F-FMISO PET|Suspected HGG subjects will undergo combined FMISO/FLT dyn-PET at baseline as part of surgical planning. Dyn-PET images will be acquired with staggered FMISO/FLT injections using a lag time of 50 minutes. Preoperatively FMISO/FLT dyn-PET data will be used for intraoperative neuro-navigation and targeted sampling of PET avid tumor subregions prior to tumor excision. Paraffin blocks will be analyzed with immuno-histochemistry and in situ hybridization for HIF-1α, Ki-67, VEGF, EGFR, IDH, and pimonidazole, as well as TERT. FMISO-PET uptake rate, k3, (surrogate for hypoxia) and FLT-PET influx rate, Ki (surrogate for proliferation) will be correlated with time to progression, progression-free survival at 9 months, and overall survival (OS) at 1 year.
15816994|NCT04309552|Drug|18F-FLT PET|Suspected HGG subjects will undergo combined FMISO/FLT dyn-PET at baseline as part of surgical planning. Dyn-PET images will be acquired with staggered FMISO/FLT injections using a lag time of 50 minutes. Preoperatively FMISO/FLT dyn-PET data will be used for intraoperative neuro-navigation and targeted sampling of PET avid tumor subregions prior to tumor excision. Paraffin blocks will be analyzed with immuno-histochemistry and in situ hybridization for HIF-1α, Ki-67, VEGF, EGFR, IDH, and pimonidazole, as well as TERT. FMISO-PET uptake rate, k3, (surrogate for hypoxia) and FLT-PET influx rate, Ki (surrogate for proliferation) will be correlated with time to progression, progression-free survival at 9 months, and overall survival (OS) at 1 year.
15816995|NCT04309539|Procedure|Fascia iliaca block|"A linear probe will be placed in the sagittal plane to the inguinal ligament to obtain an image of bow-tie sign formed by the muscle fascias, a spinal needle will be inserted 1 cm cephalad Using an in-plane approach, the fascia iliaca is penetrated, 30 mL of bupivacaine 0.25% before spinal anesthesia."
15816996|NCT04309539|Procedure|combined LFCN block with PENG block|With the patient supine, the linear probe is placed parallel to the inguinal ligament. LFCN appear as a hypoechoic oval structure between the tensor fascia lata and Sartorius muscles. The needle is inserted in plane. 5 mL of LA is injected. The PENG block will be performed in the supine position. A curvilinear probe will be placed transversely over the anterior inferior iliac spine and then rotated counterclockwise 45 degrees. the ilio pubic eminence, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle will be observed. A spinal needle will be inserted in plane to the plane between the psoas tendon and the pubic ramus. 25 mL of bupivacaine 0.25% will be injected
15816997|NCT04309526|Drug|NCO-48 Fumarate|NCO-48 Fumarate
15816998|NCT04309526|Drug|Placebo|Placebo
15816999|NCT04309513|Behavioral|PAI score to motivate physical activity|Participants will be encouraged to work up to and maintain the highest PAI score possible, with 100 being the ideal, as measured by a wearable device. Their devices and an accompanying app will provide them with an ongoing real time calculation of the PAI score.
15817000|NCT04309513|Behavioral|Step Counter to motivate physical activity|Step Counter to motivate physical activity
15817001|NCT04309500|Behavioral|Personalized DAT Risk Disclosure Protocol|Individual participants and their co-participants will receive information about the participant's DAT risk based on their clinical history, structural magnetic resonance imaging, apolipoprotein-E (APO-E) genotype, and amyloid and tau burden on positron emission tomography (PET) scanning. This session will include consent, psychoeducation, re-consent, personal risk feedback, action suggestions, participant/caregiver resources, and a written summary of results. Risk assessment and safety planning will be applied if needed.
15817002|NCT04309487|Diagnostic Test|ShuntCheck|The intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow.
15817005|NCT04309461|Behavioral|Stress Management Control|The Stress Management Program will utilize a smart phone app, accelerometers, telephone coaching, and behavioral incentives to target stress, relaxation, and sleep. Participants will wear accelerometers, log hours slept, enter real-time information about their relaxation exercises and stress, and monitor 3 goal thermometers (sleep, relaxation, stress) to meet behavioral targets. The Stress Management Program, including the use of the app and assessments, is identical to the Adapted MBC2 program, with the exception of the content.
15817006|NCT04309461|Behavioral|Adapted MBC2 Program|The Adapted MBC2 Program will utilize a smart phone app, accelerometers, telephone coaching, and behavioral incentives to target fruit and vegetable intake, dietary fat intake, physical activity, and high sedentary leisure screen time. Participants will wear accelerometers, log hours slept, enter real-time information about their relaxation exercises and stress, and monitor goal thermometers to meet targets.
15817007|NCT04309448|Behavioral|Perturbation-based balance training with functional electrical stimulation|The PBT program will consist of repetitive practice of reactive stepping for one hour. The participants will be equipped with the Odstock 2-Channel stimulator on one or both sides depending on their deficits. One channel of stimulation may be applied to the common fibular nerve to elicit a flexor withdraw reflex and elicit a step. The second channel of stimulation may be applied to the quadriceps muscles to assist with the supporting phase of the reactive step, as required. Participants will experience about 60 perturbations per session during balance exercises. To create a perturbation, the researcher will apply unexpected pushes or pulls to a safety harness around the participant's trunk. Throughout the hour-long session, participants will complete challenging balance tasks, customized to their ability level, during standing and walking. The training will be supervised by a licensed physiotherapist and administered by a licensed physiotherapist or registered kinesiologist.
15817008|NCT04309435|Behavioral|Self-esteem intervention|See relevant study arm for description
15817009|NCT04309435|Behavioral|Self-stigma intervention|See relevant study arm for description
15817010|NCT04309435|Behavioral|Jumping to conclusions intervention|See relevant study arm for description
15817011|NCT04309435|Behavioral|Control procedure (assessment only)|See relevant study arms for description
15817012|NCT04309409|Drug|Nivolumab|480 mg nivolumab fixed dose given as 60-minute iv infusion every 4 weeks for 12 doses over 1 year
15817013|NCT04309396|Device|Hydrogen content recording|Eligible participants will eat participants' normal, typical diets during the first week of the study. Participants will use the AIRE machine to measure exhaled H2 content before and after two meals each day - the first meal of the day and the last meal of the day. Participants will breathe into the AIRE machine before eating to obtain a baseline value. Once participants have finished eating, participants will breathe into the AIRE machine 30 minutes, 60 minutes, and 90 minutes postprandially. The participants will record participants' food intake and symptoms directly into participants' smartphone via an app that comes with the AIRE device.
15817015|NCT04309370|Device|20 Hz rTMS|Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique that received FDA clearance for use in treatment resistant major depressive disorder in 2008. rTMS utilizes the application of a repetitively pulsed magnetic field over the scalp to induce an electric field within a discrete area of the cerebral cortex. This electric field results in altered ion flow across the neuronal cellular membrane and ultimately changes in neuronal polarization. rTMS modulates cortical activation depending on the stimulation parameters used. Physiological studies have provided evidence that suggests that high-frequency (HF) rTMS produces an increase in local cortical excitability. Studies have also demonstrated that rTMS may increase or decrease functional connectivity between separate but related cortical structures, utilizing high and low frequency stimulation, respectively.
15817016|NCT04309357|Drug|Alteplase|Alteplase in dose 0.9 mg/kg in acute ischemic patient with indications of thrombolytic therapy
15817017|NCT04309344|Device|WEREWOLF COBLATION System|The bipolar radiofrequency-based chondroplasty device is used in the COBLATION mode (yellow) with The WEREWOLF system and the wand FLOW 50 in Lo mode (low) which are approved by the FDA for chondroplasty and debridement of the articular cartilage; fibrillations were removed and the surface was smoothed. This low energy and low suction setting minimizes damage to healthy chondrocytes surrounding and is therefore the preferred setting for the removal of articular cartilage.
15817018|NCT04309344|Procedure|control|mechanical debridement
15817019|NCT04309331|Dietary Supplement|Motion|Amino acid based protein substitute
15817020|NCT04309318|Procedure|Low pneumoperitoneum (10-12 mmHg) pressure range group|Patients who have elective laparoscopic surgery with 10-12 mmHg intra-abdominal pneumoperitoneum pressure
15817021|NCT04309318|Procedure|High pneumoperitoneum (13-15 mmHg) pressure range group|Patients who have elective laparoscopic surgery with 13-15 mmHg intra-abdominal pneumoperitoneum pressure
15817025|NCT04309292|Dietary Supplement|Prebiotic food supplement|Darmocare Pre = trade name Gut microbiome modulator
15817026|NCT04309292|Dietary Supplement|Protein supplement|commercially available protein supplementation with high leucine content
15817027|NCT04309292|Dietary Supplement|Maltrodextrin (placebo)|Starchy substance
15817028|NCT04309279|Behavioral|Zentangle|Zentangle is a mindful doodling process in which participants draw repetitive, structured patterns on small pieces of paper. The patterns consist of combinations of dots, lines, and curves.
15817029|NCT04309266|Device|Amadeo by Tyromotion|Distal upper extremity/hand robot for robot-assisted therapy
15817030|NCT04309266|Behavioral|Active Learning Protocol for Stroke|Metacognitive approach involving active problem solving for using the affected upper extremity in motoric activities. Also includes a home program.
15817031|NCT04309253|Drug|PMPBB3|F-18 PMPBB3 PET Imaging
15817032|NCT04309253|Drug|AV45|F-18 AV45 PET Imaging
15817033|NCT04309240|Drug|Rivaroxaban|Rivaroxaban 10mg orally per day for 90days
15817034|NCT04309227|Other|Strength Training|"Strength training traditionally requires use of high intensity loads to stimulate muscle growth and strength improvements. Some participants will be randomized to a traditional strength training program.
~Blood Flow Restriction (BFR) training is used to stimulate muscle hypertrophy and strength improvements in a variety of populations. Results of BFR training are comparable to traditional high intensity training (HIT) despite using weight that are at a low intensity (low percent of 1 repetition maximum). This intervention has not been extensively studies in the rheumatoid or osteoarthritis populations, nor the myositis populations despite idealogical benefit for each group of low-load strengthening."
15817035|NCT04309214|Dietary Supplement|MCT fats|Subjects will be asked to take 3 new MCT products for 7 days each over a 25 day period
15817036|NCT04309188|Device|Senaptec Strobe Glasses|The glasses use liquid crystal technology that causes a flicker from clear to opaque to enhance vision.
15817037|NCT04309188|Other|Standard softball drills|Control group, which will perform normal hitting and fielding drills without stroboscopic training
15817038|NCT04309175|Device|base rate programming of a permanent cardiac pacemaker|Base rate of a subject's pacemaker is set to a slower, and after wash-out, to a faster pacing rate (Slow-Fast Arm) or to a faster, and after wash-out, to a slower pacing rate (Fast-Slow Arm)
15817039|NCT04309162|Other|Soft tissue therapy|Soft tissue therapy consists of various soft tissue manipulating techniques which includes the stroking, percussive and tapping manipulations. The treatment techniques are divided according to the body parts. under this techniques are tapping, flat finger kneading, Stroking, skin rolling etc.
15817040|NCT04309149|Dietary Supplement|MCT fats|Subjects will be asked to take 3 new MCT products for 7 days each over a 25 day period (21 days taking the new products with 2 days between each new product trialled).
15817041|NCT04309136|Drug|Anlotinib|All patients will receive Anlotinib for at least two cycles of neoadjuvant treatment
15817042|NCT04309136|Procedure|surgery|Perform surgery if operable after neoadjuvant therapy
15817043|NCT04309136|Procedure|core needle biopsy|Perform core needle biopsy if inoperable after neoadjuvant therapy
15817044|NCT04309123|Device|TransAeris System|The TransAeris System is a temporary percutaneous intramuscular diaphragm stimulator intended for patients at risk of or on prolonged positive pressure mechanical ventilation. TransAeris is indicated for use in the prevention and treatment of ventilator-induced diaphragm dysfunction (VIDD).
15817045|NCT04309110|Device|or geko™ X-T3|The geko™ X-T3 is a next generation self adhesive medical device incorporating a new formulation skin adhesive. It is about the size of a wrist watch which attaches to the side of the knee and when switched on, gentle painless electrical pulses are produced which contract the calf muscles and increase blood flow to the lower leg. The only difference between the currently used geko™ T3 device and the new geko™ XT-3 device is the adhesive used to attach each device to the skin.
15817072|NCT04308863|Drug|MTA pulp dressing material|MTA will be gently placed over the fresh pulp wound using an MTA carrier to a thickness of 2-3 mm. It will be condensed lightly with moistened cotton pellet to attain adequate thickness and confirmed radiographically. MTA will be allowed to set for 4-5 mins.
15817046|NCT04309097|Behavioral|Digital intervention|"REAP is a live-streaming platform that allows users to shoot short videos or photos related to their physical exercise or eye relaxation (e.g., staring out of the window) using their smartphones. The app has been optimised to be used with the iPhone or Android.
~When taking a online course recess, students will have access to the REAP platform that allows them to watch stay-at-home workout videos developed by exercise physiologists. Students will then be asked to create their own workout videos/photos and upload them to the live-streaming platform. When upload is completed, students will receive instant motivational messages to increase their engagement with the program."
15817047|NCT04309097|Behavioral|Information-only intervention|Participants will have access to online health information and stay-at-home workout videos.
15817048|NCT04309084|Biological|CYNK-001|CYNK-001 is an allogeneic off the shelf cell therapy enriched for CD56+/CD3- NK cells expanded from human placental CD34+ cells.
15817049|NCT04309071|Other|Dietary intervention|Salivary insulin responses to a standardized mixed meal
15817050|NCT04309058|Drug|Vitamin D drops|Vitamin D-deficient UC patients are divided into two groups, one group is given orally with Vitamin D drops 400IU / d, while the other group do not interfere.
15817051|NCT04309045|Behavioral|DBT|Today, the most well-known and established treatment for borderline personality disorder is Dialectical Behavior Therapy (DBT) that developed by Marsha Linhan in the 1990s. DBT is currently used in other disorders such as: eating disorders, addictions, impulse control problems and bipolar disorder. Various studies have found a beneficial effect for this treatment in various areas: decreased suicidal thoughts and attempts and self-harm behaviors, improvements in suicide attempts, anger levels, impulsive behaviors, depressive symptoms, The use of drugs, the percentage of dropouts from treatment, number Hospitalization and general function.
15817052|NCT04309045|Behavioral|DDP|DDP treatment is part of a trend of dynamic therapies to treat borderline personality disorder. The DDP focuses on deficiencies in the emotional experience processing and is performed in the form of weekly, individual sessions with a trained therapist over a 12-18 month period. Treatment is based on the need to correct three neurocognitive functions responsible for adaptive processing of emotional experiences: association (the ability to recognize, understand their existence, and experience a sequence of emotional experiences), attribution (the ability to make complex attributions about the self and others), and the ability to make realistic attribution, about the self and the other. Interventions that activate these three functions are the basis for DDP treatment.
15817053|NCT04309045|Other|control group|Patients on the waiting list for treatment, or patients in the hospital under routine care.
15817054|NCT04309032|Procedure|retrograde bladder filling with 0.9% normal saline 250cc prior to removal of foley catheter|0.9% NS 250cc was introduced before foley catheter removed for discharge
15817055|NCT04309006|Procedure|CTG and customized healing abutment|screw- retained customized healing abutment
15817056|NCT04309006|Procedure|CTG and conventional healing abutment|conventional healing abutment
15817057|NCT04308993|Procedure|percutaneous transhepatic choledochoscopy|percutaneous transhepatic choledochoscopy
15817058|NCT04308980|Dietary Supplement|Specialized product for medical nutrition (SPP-1)|"Patients randomly allocated to this group will use specialized product for medical nutrition (SPP-1). This product contains: soy protein, whey protein concentrate, microcapsulated rapeseed oil, maltodextrin, inulin, Polydextrose, soy lecithin, potassium citrate, magnesium lactate, ω-3 PUFA (docosahexaenoic acid), sweetener mixture (stevia extract, erythritol), natural flavor Yogurt-vanilla, calcium carbonate, betaine hydrochloride, natural flavor raspberry, vitamin premix (vitamins a, e, C, D3, B1, B2, B6, B12, PP, folic acid, Pantothenic acid, K1, Biotin), beet juice concentrate, carrageenan, mineral premix (iron, zinc, copper, manganese, iodine, selenium, molybdenum, chromium), alpha-lipoic acid. The product is packed in approved by sanitary rules bags by 30 g. The instant drink obtained by the mixture of the bag content with warm (30-60C) water should be used immediately after being prepared. The daily dose is 1 pack TID"
15817059|NCT04308980|Behavioral|individualized diet|All the patients enrolled to the study will be provided with recommendations on diet. Individualized requirements will be calculated based on the results of indirect calorimetry (resting energy expenditures) and measurements of urea in daily urine
15817060|NCT04308967|Other|balance exercises|Three-stage progressive balance exercises will be applied.
15817061|NCT04308954|Drug|[18F]flumazenil|[18F]flumazenil is a PET radiopharmaceutical that can be used to determine gamma-aminobutyric acid (GABA(A)) receptor density.
15817062|NCT04308941|Diagnostic Test|Intraocular pressure|The intraocular pressure will be measured using one of three devices
15817063|NCT04308915|Behavioral|Game-based cognitive training|A suite of 5 games is presented to the participants for training working memory
15817064|NCT04308902|Other|VLBW|Participants previously enrolled in the Bovine vs. Human Milk-Based Fortifier Study
15817065|NCT04308902|Other|Term-born Comparison|Children born >=37 weeks gestation and weighing more than 2500g
15817066|NCT04308889|Drug|Lovaza|Lovaza contains ethyl esters of omega-3 fatty acids (EPA and DHA) obtained from the oil of several fish sources.
15817067|NCT04308889|Other|Cantharone|Cantharone is a clinical blistering agent for topical use to remove warts and molluscum contagiosum. We plan to use the drug to elicit a small skin blister and inflammatory response. This is a well described clinical inflammation research experimental model with multiple publications of its safety and utility in tracking the host inflammatory response.
15817068|NCT04308889|Other|Phlebotomy|Subjects will have blood drawn from the antecubital vein for not more than 15mL at each visit.
15817069|NCT04308876|Other|Manual therapy|Manual therapy includes techniques applied to elbow joints and surrounding tissues
15817070|NCT04308876|Other|Strengthening exercises|Strengthening exercises used in this study includes resistant exercises to increase muscle strength of upper extremity
15817071|NCT04308863|Drug|Chitosan scaffold/ MTA pulp dressing material|Chitosan 3-D porous scaffold will be prepared. The chitosan scaffolds will be examined with the Scanning electron microscopy (SEM) to analyze the surface of the chitosan scaffolds. The scaffolds will be sterilized by Ethylene oxide and stored until further use. A piece of 2-mm thick chitosan scaffold will be gently placed onto the pulp chamber floor and covering the canal orifices, and then a 2-3 mm thick layer of fast setting EndoCem Zr MTA will be applied onto the chitosan scaffold and will be gently condensed with moistened cotton pellet to attain adequate thickness which will be confirmed radiographically. MTA will be allowed to set for 4-5 mins.
15817073|NCT04308850|Drug|Vitamin D drops|Vitamin D-deficient CD patients are divided into two groups, one group is given orally with Vitamin D drops 400IU / d, while the other group do not interfere.
15817074|NCT04308837|Drug|Paclitaxel|50 mg/m2 given by intravenous infusion on days 1, 8, 15, 22 and 29.
15817075|NCT04308837|Drug|Carboplatin|Carboplatin AUC = 2 given by intravenous infusion on days 1, 8, 15, 22 and 29.
15817076|NCT04308837|Drug|Dexamethasone|All patients receiving Paclitaxel will receive institutional standard premedications, which include Dexamethasone (10 mg IVPB)
15817077|NCT04308837|Drug|Diphenhydramine|All patients receiving Paclitaxel will receive institutional standard premedications, which include diphenhydramine (50mg IVP)
15817078|NCT04308837|Drug|Famotidine|All patients receiving Paclitaxel will receive institutional standard premedications, which include Famotidine (20mg IVPB)
15817079|NCT04308837|Drug|Palonosetron|All patients receiving Paclitaxel will receive institutional standard premedications, which include Palonosetron (0.25mg IVP)
15817080|NCT04308837|Radiation|3D conformal or intensity modulated radiotherapy|Treatment will be given 5 days per week. Photon beams >6 MV are required. Treatment may be delivered either by a 3D conformal technique or IMRT. IMRT via dynamically moving MLCs, step-and-shoot with a multileaf collimator, Rapid Arc, binary multileaf collimator, and tomotherapy are allowed. Proton therapy is not allowed.
15817081|NCT04308837|Procedure|Surgical resection|Surgical resection will constitute subtotal or total gastrectomy (depending on tumor size and location) and D2 lymphadenectomy.
15817082|NCT04308837|Radiation|Adjuvant Chemotherapy|The patient will begin adjuvant chemotherapy 4-12 weeks after surgery. The adjuvant chemotherapy will consist of FOLFOX every 2 weeks for 6 cycles (i.e. 3 months)
15817083|NCT04308824|Other|clipping|a single clip will be placed in every case of polypectomy for large colorectal polyps
15817084|NCT04308824|Other|nebulization of glue|After clipping, a cyanoacrilate glue will be nebulized using a spray catheter
15817085|NCT04308811|Biological|platelet rich plasma|Platelet rich plasma and intrauterine balloon applied intrauterine after hysteroscopic adhesiolysis of intrauterine adhesions
15817086|NCT04308811|Combination Product|amniotic membrane graft group|amniotic membrane applied on the intrauterine balloon after hysteroscopic lysis of intrauterine adhesions
15817087|NCT04308811|Device|Intrauterine balloon|intrauterine balloon applied intrauterine after hysteroscopic lysis of intrauterine adhesions
15817088|NCT04308798|Procedure|Surgical glove changing|Changing surgical glove after draping and before cementation during total knee arthroplasty
15817092|NCT04308772|Behavioral|Web-based Physiotherapy|Participants will receive an exercise programme, based on those patients usually get in the form of an exercise leaflet, delivered via a web-based physio website (www.giraffehealth.com). Participants will be asked to complete their exercise programme as prescribed (at least once each day) and to fill out an online exercise diary which the physiotherapist can see remotely from the clinical site.
15817093|NCT04308759|Other|QuitBot Smoking Cessation Program|Participate in Quitbot experimental cessation program
15817094|NCT04308759|Other|Texting Smoking Cessation Program|Participate in Texting program
15817095|NCT04308746|Behavioral|Online Individualistic Prime (statement writing)|Participants write 3 statements each about (1) themselves, (2) why they are not like others, and (3) why it is beneficial to stand out from others
15817096|NCT04308746|Behavioral|Online Collectivistic Prime (statement writing)|Participants think about a social group and write 3 statements each about (1) their social group, (2) why they are like others, and (3) why it is beneficial to blend in with others
15817097|NCT04308733|Device|Anodal tDCS|patients will be stimulated over the contralateral pharyngeal motor cortex with anodal tDCS (2mA, 20 minutes) for 4 consecutive days
15817098|NCT04308707|Other|Breaking bad news skills|Communication skills analyzed by a specialized questionnaire designed from a Breaking bad news protocol developed in 2018-2019 in Barcelona.
15817099|NCT04308694|Drug|Pharmacy-based methadone administration and dispensing|Eligible participants receiving between 6- and 13-days of methadone take-home doses will have methadone administration and dispensing transferred from the opioid treatment program to the partnered community pharmacy. Each participant will be assessed monthly for 3 months (at 1, 2, and 3 months following intake/baseline) to explore the feasibility of transferring their methadone administration and dispensing to the select community pharmacy.
15817100|NCT04308681|Other|BMS-986278 Placebo|Specified Dose on Specified Days
15817101|NCT04308681|Drug|BMS-986278|Specified Dose on Specified Days
15817102|NCT04308668|Drug|Hydroxychloroquine|200mg tablet; 800 mg orally once, followed in 6 to 8 hours by 600 mg, then 600mg once a day for 4 consecutive days
15817103|NCT04308668|Other|Placebo|4 placebo tablets once, followed in 6 to 8 hours by 3 tablets, then 3 tablets once-a-day for 4 consecutive days
15817104|NCT04308655|Other|Interview|Semi-structured interviews
15817105|NCT04308655|Other|Surveys|Validated surveys on pain, fear, anxiety, depression, beliefs
15817106|NCT04308642|Other|blood test for renal biomarkers|blood test for renal biomarkers (uromodulin,Neutrophil gelatinase-associated lipocalin, beta-trace protein, creatinine, cystatin C)
15817107|NCT04308642|Other|urine test for renal biomarkers|urine test for renal biomarkers (uromodulin, alpha-1 microglobulin, retinol-binding protein, Neutrophil gelatinase-associated lipocalin (NGAL), beta-trace protein, cylinder, albumin, immunoglobulin G (IgG), transferrin, creatinine)
15817108|NCT04308629|Other|Transcranial direct current stimulation|
15817109|NCT04308616|Other|Blood samples|Blood samples
15817110|NCT04308603|Diagnostic Test|NON-IMMUNE HYDROPS FETALIS diagnosis|Amniotic liquid of each selected patients will be tested by both technic to describe and detect etiological information. Each patient will be tested using the current procedure with a defined panel of genes as well as with the NGS procedure. The results of both procedures will be compared.
15817111|NCT04308590|Drug|relacorilant|Relacorilant is supplied as 100 mg capsules for oral dosing.
15817112|NCT04308590|Other|Placebo|Placebo is supplied as 100 mg capsules for oral dosing.
15817113|NCT04308577|Other|Ketogenic diet with added MCT|The intervention is a ketogenic diet consisting of KetoCal 2,5:1 LQ MCT Multi Fibre (Nutricia), Liquigen (MCT)(Nutricia) and ketogenic meals provided by the hospital kitchen. The macronutrient composition of the ketogenic diet given approx.: Protein 11 E%, Carbohydrate 3 E%, Fat 86 E%.
15817114|NCT04308564|Diagnostic Test|Blood test|Blood test for the identification of biomarkers
15817115|NCT04308551|Drug|Indobufen|Indobufen Tablets
15817116|NCT04308551|Drug|Aspirin|Aspirin Tablets
15817117|NCT04308538|Procedure|Standard Recession|Bilateral lateral rectus muscle recession will be performed through fornix approach using standard tables
15817118|NCT04308538|Procedure|Reduced Recession|Bilateral lateral rectus muscle recession will be performed through fornix approach using reduced numbers
15817119|NCT04308525|Behavioral|Early ambulation|Early ambulation will help prevent postoperative infections, especially pneumonia and urinary tract infections. Additionally it will prevent constipation by promotion of bowel-movement and function and prevent thromboembolic complications. Patients undergoing surgery with a free fibula flap are currently unable to ambulate for 6 to 7 days while a split-thickness skin-graft is healing. We will apply a pressure dressing to the wound which makes ambulation possible immediately after surgery (or after return from the ICU). Likewise, all other patient groups will be encouraged to fully ambulate on POD (post-operative day) 1 or POD 2.
15817120|NCT04308525|Behavioral|Early oral feeding|To monitor the patients' nutritional status, blood samples will be taken to identify risk of refeeding syndrome and patients will be evaluated according to the current guidelines from the ENT (ear-, nose-, throat-) department. We wil use the ESPEN guidelines for nutritional risk screening (NRS-2002), which have been validated for head and neck cancer patients to perform a risk assessment for malnutrition. A consultation with a clinical dietician will be arranged in order to calculate the required daily nutritional intake. Patients in risk of refeeding syndrome will be closely monitored in the outpatient clinic during the time from the MDT(Multi Disciplinary Team) conference to the day of surgery. Patients in need of additional nutritional support will be provided with supplementary energy/protein drinks. Some patients may need closer monitoring, guidance regarding extra meals and to have a nasogastric tube placed to get used to the tube and optimize pre-operative nutritional status.
15817121|NCT04308525|Other|Multimodal opioid-sparing analgesia|"On-label use of already approved drugs including perioperative dexamethasone, administered with the aim of reducing opioid intake.
~Pre-operatively the patients are given 400 mg of Celebra. During surgery 24 mg of dexamethasone is administered. The post-operative regimen consists of 12 mg of Dexamethasone 48 and 96 hours post-operatively, 200 mg of Celebra morning and evening (maximum 14 days) and 1g of paracetamol times four times daily. Morphine will only be administered when assessed necessary with a dose of 10 mg p.n. maximum six times a day."
15817122|NCT04308525|Procedure|Goal-directed fluid therapy|Focus on avoidance of over-hydration. Aim for fluid-load after surgery: max: +1000-1500 ml
15817123|NCT04308525|Procedure|CAD/CAM system for reconstructive plates|Computer-assisted design and modelling (CAD/CAM) are a system for pre-operative planning and construction of reconstructive plates used for mandibular reconstruction. This will help reduce the operating-time, as the maxillofacial surgeon will bring a pre-bent reconstructive plate to the procedure instead of manually forming it during surgery. Already implemented for several procedures in the department.
15817124|NCT04308525|Other|Functional discharge criteria|Introduction of a number of functional discharge criteria to avoid prolonged postoperative hospitalisation
15817125|NCT04308525|Other|Standard/historical postoperative regimen|Non-formalised historical peri- and postoperative regimen.
15817126|NCT04308512|Device|Care4AD system|Eligible subjects will be randomized to intervention, IG, and control groups, CG, with ratio of 1:1 and will be assessed at baseline and six months. All reminders will be activated in the intervention group and de-activated in the control group. Essential ADL tasks will be preprogrammed by our care coordination expert for the IG. Patients and their caregivers in the IG will be also able to schedule additional tasks.
15817127|NCT04308499|Behavioral|Digital cognitive-behavioral therapy for insomnia (dCBTI)|Internet-based cognitive-behavioral therapy for insomnia (CBT-I) structured into 6 weekly sessions accessed using either a computer or a smartphone
15817128|NCT04308499|Behavioral|Sleep hygiene education (SHE)|Recognized and commonly prescribed set of sleep hygiene instructions comprised of comprise a website and a downloadable booklet
15817129|NCT04308473|Other|Ultra-processed Food Meal|An ultra-processed diet challenge test utilizing 1) potatoes fried in highly refined and processed vegetable oil, including corn, soybean, or canola oil, with wheat and milk derivatives; 2) a beef patty sandwich containing processed American cheese, enriched refined flour, mold inhibitor, preservatives and oxidation/reduction additives such as ascorbic acid, potassium/calcium iodate, alpha-amylase, and azodicarbonamide; and 3) a beverage composed of carbonated water, high fructose corn syrup and caramel coloring. The ultra-processed challenge meal will be obtained from a local restaurant on the day of the challenge test.
15817130|NCT04308473|Other|Whole Food Meal|A whole food diet challenge test utilizing 1) a side salad comprised of fresh leafy vegetables, and typical whole food toppings including fresh onion, fresh tomato, fresh carrots, and raw walnuts with a pure unrefined olive oil salad dressing; 2) a legume-based main dish including chickpeas, lentils and whole grain quinoa; 3) a fresh berry-rich smoothie beverage consisting of organic blueberries, raspberries, strawberries, bananas, and fresh orange juice. The whole food challenge meal will be made by the study team from readily available commercial foods bought from local grocery stores.
15817131|NCT04308460|Procedure|arthrocentesis|lavage of the temporomandibular joint was done
15817132|NCT04308460|Procedure|operative arthroscopy|operative intervention inside the temporomandibular joint was done using arthroscope
15817133|NCT04308447|Device|AbleLite|The AbleLite device is a passively powered orthotic device designed to support and assist the arms of patients with neuromuscular weakness for activities of daily living.
15817134|NCT04308434|Other|CSD190601-11|Flavor variant CSD190601-11 of a 1.5% nicotine ENDS product
15817135|NCT04308434|Other|CSD190601-12|Flavor variant CSD190601-12 of a 1.5% nicotine ENDS product
15817136|NCT04308434|Other|CSD190601-13|Flavor variant CSD190601-13 of a 1.5% nicotine ENDS product
15817137|NCT04308434|Other|CSD190601-14|Flavor variant CSD190601-14 of a 1.5% nicotine ENDS product
15817138|NCT04308434|Other|CSD190601-15|Flavor variant CSD190601-15 of a 1.5% nicotine ENDS product
15817139|NCT04308434|Other|CSD190601-16|Flavor variant CSD190601-16 of a 1.5% nicotine ENDS product
15817149|NCT04308408|Behavioral|Guideline Daily Amounts|All food items displayed the corresponding GDA label in the lower left corner of the front of the package.
15817150|NCT04308408|Behavioral|Multiple Traffic Light|All food items displayed the corresponding MTL label in the lower left corner of the front of the package.
15817151|NCT04308408|Behavioral|Warning Labels|"Food products were labeled with High in labels In the lower left corner of the front of the package. In total, 37 of the 60 food products in the shopping site did not display a WL."
15817152|NCT04308408|Behavioral|Video|Participants viewed a short (less than 1 min) video explaining how to interpret the label.
15817153|NCT04308395|Drug|Patidegib Topical Gel, 2%|Patidegib Topical Gel, 2%
15817154|NCT04308382|Behavioral|Health Risk Assessment|"Heath Risk Assessment consists of:
~Survey to include questions about physical activity, stress, hope, household hunger and demographics.
~Lipid panel and HbA1c
~Height and Weight, blood pressure and resting pulse"
15817155|NCT04308369|Biological|Blood collection arm|Blood collection will be performed before the spa therapy (Day 0), at the end of the spa therapy (Week 3) and 6 months later (M6). In this study, blood samples will be collected by a nurse of the service and centralized by the laboratory of Medical Biology of the General hospital of Dax.
15817156|NCT04308356|Behavioral|Dedicated Discussions on Anticipating preferences of care in the event of Aggravation (DDA)|interview 2
15817157|NCT04308356|Other|Autonomy Preference Index (API ) questionnaire - Information|part of interview 1
15817158|NCT04308356|Other|anxiety and depression (HADS) questionnaire|part of interview 1
15817159|NCT04308343|Drug|Methotrexate|Drugs to treat undisturbed ectopic pregnancies
15817160|NCT04308343|Drug|Letrozole|Drugs to treat undisturbed ectopic pregnancies
15817161|NCT04308343|Drug|cetrotide|Drugs to treat undisturbed ectopic pregnancies
15817162|NCT04308330|Drug|Vorinostat|This is a phase I study of the combination of four drugs: vorinostat, vincristine, irinotecan, and temozolomide. This is called a Phase I study because the goal is to find the highest dose of vorinostat that investigators can give safely when it is used together with the chemotherapy drugs vincristine, irinotecan and temozolomide. Investigators are using vorinostat because it seems to work against cancer in test tubes and animals. It may be most effective when it is given with chemotherapy. The combination of these three agents together has never been given to children. Vincristine, irinotecan, and temozolomide are approved and used for the treatment of other types of cancer in adults and children. Vorinostat is approved and used to treat cancer in adults. The combination of these four drugs together is experimental. Investigators do not know if this combination of medicines will work in people. There is a lot that investigators do not yet know about this combination of medicines.
15817163|NCT04308317|Drug|Tetrandrine|Tetrandrine 60mg QD for 1week
15817167|NCT04308291|Device|MiniMed™ 780G System|Subject enrolled in the study will start using the MiniMed™ 780G pump in Auto Mode after a run-in period of two weeks in Manual Mode (with no SmartGuard™ functions). Study phase in Automode will follow a 6 and 12 months follow- up as per standard of care.
15817168|NCT04308278|Drug|2LEBV® / 2LXFS®|The treatment schema consists in taking the content of one capsule a day, 15-30 minutes before breakfast, on an empty stomach, sequentially, according to capsules' numerical order: 1 through 10. When capsule number 10 is taken, capsule 1 of the next blister should be taken on the next day to continue the treatment. The duration of treatment will be 6 months of continuous intake of the content of 1 capsule/day.
15817169|NCT04308278|Drug|Placebo|The treatment schema consists in taking the content of one capsule a day, 15-30 minutes before breakfast, on an empty stomach, sequentially, according to capsules' numerical order: 1 through 10. When capsule number 10 is taken, capsule 1 of the next blister should be taken on the next day to continue the treatment. The duration of treatment will be 6 months of continuous intake of the content of 1 capsule/day.
15817170|NCT04308239|Behavioral|Reactive balance training|Participants were exposed to simulated trips and slips under safe, controlled conditions in order to practice their reactive response to these common balance perturbations.
15817171|NCT04308239|Behavioral|Otago Balance Training|Balance exercises and strength exercises using ankle weights, and were progressively increased as performance improved by increasing ankle weights or the difficulty of the balance exercises (e.g., not holding onto a wall or support).
15817172|NCT04308226|Behavioral|Patient Navigation|The navigator's principal role is to guide participants through the lung cancer screening (LCS) process. The navigator will work within the existing Boston Health Care for the Homeless (BHCHP) clinical structure and collaborate with participants' primary care providers (PCPs) to facilitate LCS low-dose computed tomography (LDCT) referral, completion, and timely follow-up by addressing participants' barriers to LCS completion and enhancing participants' self-efficacy. The navigator's secondary role is to offer brief tobacco counseling for participants who currently smoke.
15817173|NCT04308213|Device|Marrow Cellution System|The treatment will be carried out in the operating room under ordinary hospitalization and provides the intra-articular application of 9 ml of autologous bone marrow aspirate in the glenohumeral joint affected by arthrosis. To obtain the necessary amount, a bone marrow aspirate of about 12 ml will be taken from the iliac crest by means of the Marrow Cellution System, Geistlich Italia. This autologous bone marrow aspirate will be injected using the same syringe into the glenohumeral joint affected by arthrosis under amplioscopic control.
15817174|NCT04308200|Other|CO-OP approach|"There are 3 stages in the CO-OP approach. Stage I, the Preparation Stage, is primarily concerned with establishing the goal. Before the first interview, the child was contacted, the family and the child were informed, and it was checked whether they met the prerequisites. At this stage, 3 targets were selected and the basic performance level was determined. Stage II, the Acquisition Stage, is essentially the plan and do stage, in which the work of using strategies to acquire skills is done. This stage originally comprised 10 sessions. At this stage, the first session enabling principles were implemented and the global strategy goal-plan-do-check was introduced. The family attended this process with observation. Parents / caregivers were encouraged to make observations to generalize strategies. Stage III, the Verificatíon stage usually consists of only one session in which control is performed; the progress made was revised as learned strategies."
15817175|NCT04308200|Other|NDT|All participations received NDT for 45 minutes once daily, two times a week for period of 6 weeks by the same physiotherapist. The NDT protocol is improving muscular tone and movement patterns. Although the treatment activities varied for each CP participant, the overall goals (improved smoothness and efficiency of movement), which included improved trunk, hip, knee and ankle control, were the same for all CP participants. All sessions incorporated handling techniques that aimed to alter muscle tone during movement and to facilitate anti-gravity, weight-shifting and postural reactions.
15817176|NCT04308174|Drug|Durvalumab + Gem/Cis|Neoadjuvant Durvalumab + Gemcitabine/Cisplatin
15817177|NCT04308174|Drug|Gem/Cis|Neoadjuvant Gemcitabine/Cisplatin
15817178|NCT04308161|Drug|vitamin D oral gel|vitamin D is a fat soluble vitamin which has important calcemic roles in the body regarding bone homeostasis and calcium/phosphorus balance. Recently, the non-calcemic roles of vitamin D as anti-inflammatory, anti-oxidant and immuno-regulatory functions have been widely reported.So, we tried to use it for prevention of radiation induced oral mucositis
15817179|NCT04308161|Drug|Miconazole Topical Gel|topical anti fungal agent
15817180|NCT04308161|Drug|BBC oral spray|Topical anesthetics and anti-inflammatory agent
15817181|NCT04308161|Drug|Oracure gel|Topical analgesic gel
15817182|NCT04308161|Other|Alkamisr sachets|Sodium bicarbonate mouthwash
15817183|NCT04308135|Diagnostic Test|Neuro-radiological tools:|"MRI brain: to measure white matter
~c) Ultrasonographic examination of extracranial vessels: The intimal medial thickness of the common carotid artery (CCA-IMT) will be measured in B-mode. The carotid arteries will be evaluated for the presence of atherosclerotic lesions (plaques) either soft or hard .The residual lumen and degree of stenosis will be measured. The peak systolic velocity will be detected."
15817184|NCT04308135|Diagnostic Test|cognitive tests|"All patients will be evaluated for global cognitive assessment by: Montreal Cognitive Assessment (MoCA) (Arabic version) Visuospatial skills will be assessed by Clock Drawing Tests from MoCA test and copy the intersecting pentagons from Addenbrooke's test (Arabic version) Language will be examined by semantic fluency from Addenbrooke's test (Arabic version) and similarities from Wechsler Adult Intelligence Scale (WAIS) Attention will be evaluated by digit span from Wechsler test),and by the number of seconds needed to sequence numbers using a pencil (Trail making test A) from MoCA test . For the evaluation of memory, participants will complete Wechsler memory subset
~, and the investigators also will use their three-item recall from the Mini-Mental State Examination( MMSE). Executive functions will be measured by Wisconsin card sorting test and also verbal fluency test from Addenbrooke's test. Frontal Assessment Battery (FAB) scale"
15817185|NCT04308135|Diagnostic Test|lab investigations|Each patient will undergo full lab investigations:[lipid profile ,complete blood count, uric acid ,Hemoglobin A1c (HbA1c), liver functions, renal functions, and electrolytes]
15817186|NCT04308135|Diagnostic Test|Beck depression inventory (BDI)(Arabic version)|Clinical Tool for depression
15817187|NCT04308135|Diagnostic Test|Clinical Tools for Urinary symptoms:|the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Scale (Arabic version)
15817188|NCT04308135|Diagnostic Test|Freezing of gait questionnaire|"Clinical Tools for Gait (in on and off state ), Gait will be assessed by:
~.Freezing of gait questionnaire
~Berg balance scale.
~10 meter walk test .
~Timed up and go test."
15817189|NCT04308135|Diagnostic Test|non-motor symptoms scales (NMSS).|Clinical Tool for assessment of non-motor symptoms of PD
15817190|NCT04308135|Diagnostic Test|Movement Disorders Society- Unified Parkinson's Disease Rating Scale (MDS-UPDRS):|"Clinical Tools for assessment of the neurological severity and stage of disease Clinical Tool for assessment of the neurological severity and stage of disease during OFF and ON states, Hoehn and Yahr scale. The presence of lower limb parkinsonism will be determined by a two-point difference between upper limb and lower limb scores of bradykinesia, rigidity or postural instability from part III of the MDS-UPDRS. Patients will be examined in the early morning, in 'OFF' state, with MDS-UPDRS, Hoehn and Yahr and freezing of gait questionnaire(FOG-Q) scales. Immediately afterwards, they will take their regular first dose of levodopa. After 1 hour, patients will be examined again with the same tests and scales.
~Response to levodopa will be determined as patients who reached a percentage reduction exceeding 25% in part III of the MDS-UPDRS"
15817191|NCT04308135|Diagnostic Test|ELIZA for alpha-synuclein|measuring serum of alpha-synuclein, tau and their autoantibodoies
15817192|NCT04308135|Other|transcranial color-coded duplex(TCCD)|TCCD using phase array 2.4 Hz probe for evaluation of cerebral vasomotor reactivity (CVR) by measuring the Breath holding index(BHI),flow velocities and pulsatility index of middle cerebral artery and posterior cerebral artery on both sides.
15817193|NCT04308135|Other|extracranial carotid duplex|to assess atherosclerosis, stenosis of carotids
15817194|NCT04308135|Other|The Arabic version of Parkinson's Disease Questionnaire( PDQ-39)|Clinical tool for quality of life of PD patients
15817195|NCT04308122|Device|Cervical Orthosis (CO)|Immediately following surgery patients in the CO group will be fitted with a Philadelphia collar prior to being transferred to the recovery room. On the patient ward a physiotherapist will fit the patient with a Cervimax/Aspen/Miami J collar which will be worn at all times for 6 weeks according the standard of care.
15817196|NCT04308122|Device|No Orthosis|The NO group will have no specific precautions applied to their neck range of motion.
15817197|NCT04308109|Behavioral|Simulation|Simulation involves the use of a highly realistic tracheostomy mannequin and audiovisual devices which will be used to replicate emergent clinical situations. If home invasive ventilation is anticipated, a home ventilator will be used. The simulation will last approximately 2 hours and will end with reviewing the taped session as part of debriefing. Both active arms will occur in the simulation center or sleep lab and replicate the same clinical situations by the same simulation instructor.
15817198|NCT04308096|Drug|KRN23|The starting dose of KRN23 will be the dose used for the last administration in the preceding studies. The dose may be modified subsequently in accordance with the criteria for dose and dose adjustment.
15817199|NCT04308083|Procedure|dental implant placement|Implants will be placed according to the manufacturer recommendations. Implants will be placed at 1.5 to 2.0 mm from the adjacent natural tooth. However, these distances will be directed by the prosthetic crown needed and they will be recorded in the CRF.
15817279|NCT04307420|Procedure|Composite Resin Restoration|Composite resins are polymer-based materials used in dentistry for aesthetic repairs.Polymerization is accomplished typically with a hand held curing light that emits specific wavelengths keyed to the initiator and catalyst packages involved.
15817200|NCT04308070|Device|AQUABEAM System followed by catheter without hemostatic agent|The AquaBeam system delivers a high-pressure saline stream under precise electromechanical control and live ultrasound guidance to ablate prostatic glandular tissue without the production of heat. The physician uses ultrasound imaging to plan the treatment contour and depth to define the treatment region. The physician will use balloon catheter to achieve hemostasis post-Aquablation procedure.
15817201|NCT04308070|Device|AQUABEAM System followed by catheter with hemostatic agent|The AquaBeam system delivers a high-pressure saline stream under precise electromechanical control and live ultrasound guidance to ablate prostatic glandular tissue without the production of heat. The physician uses ultrasound imaging to plan the treatment contour and depth to define the treatment region. The physician will use balloon catheter with hemostatic agent to achieve hemostasis post-Aquablation procedure.
15817202|NCT04308057|Procedure|Aquatic exercise|Participants belonging to Group D (sedentary group) will be randomised 1-to-1 between remaining sedentary (n=20) and following a self-managed, 8-week, aquatic-based exercise programme (n=20). The latter group will be offered an 8-week access to pool facilities. For Group D participants, all baseline assessments will be repeated at 8 weeks.
15817203|NCT04308031|Drug|Ivabradine 5 mg [Corlanor]|Starting dose: Ivabradine 2.5mg twice daily (BID) Max Dose: Ivabradine 7.5 mg twice daily (BID)
15817204|NCT04308031|Drug|Digoxin 0.25 mg|Starting dose: 0.125mg once daily (QD) in estimated Glomerular filtration rate(eGFR)>60， 0.125mg once every other day (QOD) in estimated Glomerular filtration rate(eGFR)<60 Max dose: 0.25 once daily (QD)
15817205|NCT04308018|Procedure|S2alar-iliac screws|Caudal end of the instrumentation at iliac bone via S2alar-iliac screws
15817206|NCT04308018|Procedure|S1 screws|Caudal end of the instrumentation at S1
15817207|NCT04307992|Device|Prophylactic sac filling with AneuFix|ANEUFIX is administered through translumbar injection into the AAA using imaging techniques to guide the place of injection.
15817208|NCT04307979|Dietary Supplement|High-fat coffee|A high fat coffee that consists of 29 grams of added fat from grass fed ghee, and MCT oil.
15817209|NCT04307979|Dietary Supplement|Black coffee|A regular black coffee with no added caloric content.
15817210|NCT04307966|Behavioral|The CIrCLE of Life Initiative|HIV and obesity prevention programme delivered directly to Grade 6 preadolescents and indirectly to their parents.
15817211|NCT04307953|Drug|AZD0530 Difumarate|AZD0530 for the duration of the trial
15817212|NCT04307953|Drug|Matching placebo|Matching placebo during 6 month RCT, AZD0530 thereafter
15817213|NCT04307940|Drug|Naproxen Sodium (Aleve, BAY117031)|220 mg per tablet, two tablets (440 mg), intake a single dose orally.
15817214|NCT04307940|Drug|Hydrocodone/Acetaminophen|5/325 mg per tablet, two tablets (10/650 mg), intake a single dose orally.
15817215|NCT04307940|Drug|Placebo|two tablets, intake a single dose orally.
15817216|NCT04307914|Radiation|External beam radiotherapy|The current standard of care for patients with uncomplicated painful bone metastases is palliative locoregional external beam radiotherapy, often in combination with systemic therapy and analgesics.
15817217|NCT04307914|Procedure|MR-HIFU|MR-HIFU is a non-invasive treatment modality that delivers acoustic energy to heat tissue to ablative temperatures of more than 60°C. The combination of focused ultrasound with magnetic resonance imaging (MRI) enables physicians to perform localized tumor tissue ablation, with real-time temperature monitoring using magnetic resonance (MR) thermometry.
15817218|NCT04307901|Device|Colon capsule endoscopy|Endoscopy performed using PillCam2 camera capsule for oral ingestion
15817219|NCT04307888|Device|Perclose Proglide (Abbott)|Common Femoral Artery percutaneous access closure by means of Perclose Proglide device
15817220|NCT04307875|Diagnostic Test|Blood pressure measurement (sphygmomanometer)|measuring blood pressure with standard sphygmomanometer
15817221|NCT04307875|Diagnostic Test|Blood glucose measurement|measuring blood glucose using standard measurement devices
15817222|NCT04307875|Other|psychometric tests|WHODAS 2.0, PHQ-9, CAPS-5
15817223|NCT04307862|Drug|ZEP-3Na|The Investigational Product will be applied topically twice daily for up to 12 weeks.
15817226|NCT04307836|Device|Renal Denervation|Renal Denervation: DENEX system
15817227|NCT04307823|Other|Treadmill training|"3 days per week, starting at shorter duration 5-20min and progressed to 30- 40mins.
~Training% or Intensity was kept 40-70%,
~Training Heart Rate (HR) was calculated through formula:
~HR max HR rest*Ex intensity + HR rest Rate of Perceived Exertion (RPE) 9-14 ON 6 -20 RPE scale The session was terminated if sustained ventricular arrhythmia, symptomatic drop in blood pressure, ST elevation, or development of severe symptoms"
15817228|NCT04307823|Other|Treadmill protocol and Respiratory training|"Treadmill protocol
~Spirometry:
~Volumetric exercises, using incentive Spirometer 10-15 repetitions
~Slow breathing training:
~5 minutes: spontaneous breathing, 4 minutes: controlled breathing (15 breaths/min) 4 minutes of controlled breathing (6 breaths/min) Treatment provided for 3 days in a week for a period of 4 weeks"
15817229|NCT04307797|Drug|0.9% Sodium-chloride|Part A - 0.9% saline infusion during cardiac PET-MRI scan
15817230|NCT04307797|Drug|Exenatide (50ng/min for 30 minutes loading followed by 25ng/min maintenance) and glucagon 12.5ng/kg/min|Part A - exenatide and glucagon infusion during cardiac PET-MRI scan
15817231|NCT04307797|Drug|Glucagon 12.5ng/kg/min and 0.9% saline|Part A - Glucagon and 0.9% saline infusion during PET-MRI scan
15817232|NCT04307797|Drug|0.9% Sodium-chloride|Part B - 0.9% saline infusion during 7T 31P MRS scan
15817233|NCT04307797|Drug|Exenatide (50ng/min for 30 minutes loading followed by 25ng/min maintenance) and glucagon 12.5ng/kg/min|Part B - exenatide and glucagon infusion during 7T 31P MRS scan
15817234|NCT04307797|Drug|Glucagon 12.5ng/kg/min|Part B - Glucagon infusion during 7T 31P MRS scan
15817235|NCT04307784|Dietary Supplement|VD3|VD3 (50.000 IU/week) for 8 weeks
15817236|NCT04307784|Dietary Supplement|Omega-3FA|Omaga-3FA (300 mg/day) for 8 weeks
15817237|NCT04307784|Dietary Supplement|VD3 and Omega-3FA|VD3 (50.000 IU/week) and (Omega-3FA 300 mg /day) for 8 weeks
15817238|NCT04307784|Other|Control|No intervention is given
15817239|NCT04307771|Behavioral|m-Health application|Dental Buddy is a mobile application that has been designed to improve oral hygiene maintenance behaviours in teenagers
15817240|NCT04307758|Other|Muscle Strength Assesment-Make Test|For the make test, the examiner applies resistance in a fixed position and the person being tested exerts a maximum effort against the dynamometer and examiner. The examiner is only required to sustain an isometric contraction and read the highest value on an Hand Held Dynamometer.
15817241|NCT04307758|Other|Muscle Strength Assesment-Break Test|For the break test, the examiner applies resistance sufficient to overcome the maximum effort of the person being tested and cause the subject's joint to move in the opposite direction, which results in an eccentric contraction. During this test the limb must move at a constant velocity while the person being tested is asked to achieve a maximum contraction. In addition, the examiner must read the force output reading at the exact time the subject's limb begins to move from the Hand Held Dynamometer.
15817242|NCT04307745|Other|Primary prevention|The primary prevention that the 4 groups put in place for the upper limp athletes
15817243|NCT04307706|Behavioral|Acceptance and Commitment Therapy|The Acceptance and Commitment Therapy Based Intervention Program was applied to the intervention group in six sessions. The duration of each session lasted on average 60-90 minutes. A session was held for each parent once a week.
15817244|NCT04307693|Drug|Lopinavir/ritonavir|Lopinavir / Ritonavir tablet
15817245|NCT04307693|Drug|Hydroxychloroquine sulfate|Hydroxychloroquine sulfate tablet
15817246|NCT04307680|Device|Peritron perineometer|Perineometry will be used to assess quality of each observed treatment modality.
15817247|NCT04307667|Biological|Whole lung antigen challenge (WLAC)|Whole lung antigen challenge with cat hair, house dust mite, short ragweed or cat hair allergen extracts.
15817248|NCT04307667|Radiation|[18F]FEPPA|[18F]FEPPA is a radiotracer selective for translocator protein (TSPO) binding, which is elevated in activated microglia.
15817249|NCT04307641|Behavioral|2 Page Information Sheet|2 page information sheet about medication abortion
15817250|NCT04307628|Other|Walnut|Study participants will eat 2 ounces of walnuts each day.
15817251|NCT04307628|Other|Nut-Free|Study participants will not eat nuts.
15817252|NCT04307615|Combination Product|Oxygen + continuous positive airway pressure (CPAP)|Oxygen-driven CPAP (7,5 cmH2O): 20 min treatment followed by 10 min rest and assessment
15817253|NCT04307615|Drug|Oxygen|Oxygen: 20 min treatment followed by 10 min rest and assessment
15817254|NCT04307602|Other|Exercise - High Intensity Interval Training (HIIT)|Exercise in the walk aid Innowalk for children for children with CP GMFCS IV-V, Exercise on spinning bike for children with CP GMFCS I-II and non-disabled children
15817255|NCT04307602|Other|Exercise - Submaximal Steady State Training (SST)|Exercise in the walk aid Innowalk for children for children with CP GMFCS IV-V, Exercise on spinning bike for children with CP GMFCS I-II and non-disabled
15817256|NCT04307589|Other|Observation|An observational follow-up study will be implemented over a period of 2 years, consisting of 3 test occasions with a fixed time interval of 1 year in between (T0 = baseline, T1 = 12 months, T2 = 24 months). Data will be collected in participants who provide grandchild care in a non-residential grandparent context as well as in a sample of non-caregiving grandparents and a sample of middle-aged and older adults not being a grandparent. All three samples will thus be prospectively monitored over a period of 2 years.
15817257|NCT04307576|Drug|Omitted Doxorubicin|Omission of IV Doxorubicin
15817258|NCT04307576|Drug|Omitted Vincristine+Dexamethasone pulses|Omission of Vincristine+Dexamethasone pulses
15817259|NCT04307576|Drug|Inotuzumab Ozogamicin+Standard Maintenance Therapy|Addition of IV Inotuzumab ozogamicin before Maintenance Therapy
15817260|NCT04307576|Drug|Imatinib|p.o. Imatinib
15817261|NCT04307576|Drug|6-tioguanine+Standard Maintenance Therapy|Addition of p.o. 6-tioguanine to Standard Maintenance Therapy
15817262|NCT04307576|Drug|Blinatumomab|IV Blinatumomab
15817263|NCT04307563|Behavioral|Mindfulness session|1.5 hour weekly session with health educator
15817264|NCT04307550|Drug|Isopropyl alcohol|10 inhalations of an isopropyl alcohol pad
15817265|NCT04307550|Other|Placebo|10 inhalations of a sterile saline pad
15817266|NCT04307537|Procedure|Post-urethroplasty urethrography|Imaging of the urethra after reconstructive surgery to identify contrast leakage (no, insignificant, signficant).
15817267|NCT04307524|Procedure|laparoscopic repair|laparoscopic suture repair of cesarean scar niche
15817268|NCT04307524|Drug|medical treatment in the form of combined hormonal contraception|"patient will receive for three months daily without interruption, no pill-free interval drug names is Genera BAYERhealthcare"
15817269|NCT04307511|Drug|Ticagrelor|60mg ticagrelor based DAPT vs 90mg ticagrelor based DAPT vs 90mg ticagrelor monotherapy
15817270|NCT04307511|Drug|Aspirin|Aspirin
15817271|NCT04307498|Behavioral|Intensive Outpatient Program - Prolonged Exposure|Prolonged Exposure for Posttraumatic Stress Disorder (PE for PTSD; Foa, Hembree, & Rothbaum, 2007) is an empirically supported behavioral therapy that utilizes exposure-based interventions to target the psychological mechanisms (i.e., avoidance; maladaptive cognitive changes) thought to maintain trauma-related symptoms. IOP-PE includes 15 days of PE treatment delivered over three consecutive weeks. The standard outpatient PE protocol has modified with seven treatment augmentations to meet the unique needs of post-9/11 veterans.
15817272|NCT04307485|Drug|Ticagrelor|90mg ticargrelor based DAPT vs 60mg ticargrelor based DAPT
15817273|NCT04307472|Behavioral|Clinician Nudge|Active choice intervention in the electronic health record and peer comparison messaging on performance
15817274|NCT04307472|Behavioral|Patient Nudge|Text message sent to patients to prompt awareness of statin eligibility before an appointment with their primary care physician
15817275|NCT04307459|Other|standard operating procedures|standard operating procedures represented by continuous positive airway pressure (CPAP) therapy or non invasive ventilation, pharmacological treatment as antiviral and antibiotic drugs, bronchodilators, xanthines, enteral nutrition, hydration.
15817276|NCT04307446|Device|Immersive Virtual Reality|Immersive Virtual Reality
15817277|NCT04307433|Behavioral|Storytelling narrative videos on tablets|The storytelling narrative episodes in the application will feature video clips of the multiple stories of women living with HIV infection, HIV support group leaders, community leaders, and health care professionals and a Learn More video of physician discussing cervical cancer.
15817278|NCT04307420|Procedure|Sonic Fill Restoration|Kerr's Sonic Fill is the only sonic-activated, single-step, bulk-fill composite that starts out as a low-viscosity composite.
15817280|NCT04307407|Behavioral|Aerobic Exercise|Participants will be randomized to supervised aerobic exercise or standard care. Women with no current or past malignant disease will comprise the reference group and will be matched for age to participants in the Aerobic Exercise arm
15817281|NCT04307394|Behavioral|LifePlans|LifePlans is a video-based intervention, in which patients watch episodes starting during a psychiatric hospitalization and continuing through 1 month post-discharge.
15817282|NCT04307381|Drug|IONIS-PKK-LRx|IONIS-PKK-LRx administered SC
15817283|NCT04307368|Other|FODMAP diet|8 weeks of diet low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAP)
15817284|NCT04307368|Other|Elimination-rotational diet|During the patient's first visit an IgG antibody titration test against specific nutrients will be performed to determine food hypersensitivity. Based on the results of the obtained food panels, patients will be offered an elimination-rotational diet for a period of 8 weeks.
15817285|NCT04307368|Other|Classic diet|8 weeks of classic diet treatment (recommended by the gastroenterologist who supervises them).
15817286|NCT04307355|Device|Transcu O2®|Participants randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.
15817287|NCT04307342|Procedure|MIPO with Extra-articular Distal Humeral Anatomical Plate|MIPO with Extra-articular Distal Humeral Anatomical Plate
15817288|NCT04307329|Biological|Monalizumab|Monalizumab 750 mg every two weeks
15817289|NCT04307329|Biological|Trastuzumab|Trastuzumab 4 mg/kg every two weeks
15817290|NCT04307316|Other|ACBT group|"ACBT:
~Breathing control 3 to 4 Thoracic Expansion Exercise A: 3 seconds hold B: Chest clapping C: Chest vibration Forced Expiratory Technique Breathing control A: 3 seconds hold B: Chest clapping C: Chest vibration 3 to 4 Thoracic Expansion Exercise Breathing control 1-2 Huff combine with breathing control Huff and cough
~Chest Physical Therapy Early mobilization"
15817291|NCT04307316|Other|Conventional Physical therapy|Chest percussion, deep breathing, Huff and cough. Early mobilization
15817292|NCT04307303|Device|abdominal functional electrical stimulation|functional electrical stimulation of the abdominal muscles
15817293|NCT04307290|Drug|Dexmedetomidine Hydrochloride, or Saline|drug infusion from 10 min before the start of surgery to the end of surgery
15817294|NCT04307277|Drug|Standard of care + chemotherapy|Doxorubicine with Ifosfamide during 4 cycles Q3W Or Doxorubicine with Dacarbazine during 4 cycles Q3W (for patients with Leiomyosarcoma)
15817295|NCT04307277|Other|Standard of care|Surgical excision with external radiotherapy (if applicable)
15817296|NCT04307264|Procedure|Esophagogasrtoduodendoscopy, liver stiffness measurement|Time frame between liver stiffness measurement and esophagogastroduodendoscopy is less than 2 weeks.
15817297|NCT04307251|Device|Navio™ Robotics-assisted Surgical System, LEGION Total Knee System|Robotic TKA uses computer software to convert anatomical information into a virtual patient-specific 3D reconstruction of the knee joint.The surgeon uses this virtual model to plan optimal bone resection, implant positioning, bone coverage, and limb alignment based on the patient's unique anatomy.
15817298|NCT04307251|Device|Conventional, LEGION Total Knee System|Total Knee Arthroplasty (TKA) is a widespread orthopaedic procedure for restoring functionality and minimizing pain due to end stage osteoarthritis. Conventional TKA, well-accepted as the standard of care, is performed with manual instrumentation guided by intramedullary or extramedullary alignment rods, as well as rotational guides that are not patient-specific.
15817299|NCT04307238|Diagnostic Test|PLR|PLR measurements will be performed within the first 2 postoperative hours.
15817300|NCT04307238|Diagnostic Test|Alertness testing|Preoperative (baseline) and every 30 minutes postoperative computer based alertness testing will be performed.
15817301|NCT04307238|Procedure|Propofol anesthesia|Maintenance of anesthesia will be performed using propofol.
15817302|NCT04307238|Procedure|Sevoflurane anesthesia|Maintenance of anesthesia will be performed using sevoflurane.
15817303|NCT04307225|Device|Zenicor|Handheld Thumb ECG monitoring device
15817304|NCT04307212|Other|50% heart rate reserve (HRR) low intensity exercise|Trained and untrained participants will exercise at a constant load intensity of 50% HRR (low intensity)
15817305|NCT04307212|Other|75% HRR moderate intensity exercise|Trained and untrained participants will exercise at a constant load intensity of 75% HRR (moderate intensity)
15817306|NCT04307212|Other|Control no exercise|Trained and untrained participants will have a no exercise control day
15817307|NCT04307199|Procedure|Amniotic membrane sweep|Amniotic membrane sweeping is defined as the manual detachment of the inferior pole of the amniotic membranes from the lower uterine segment. This is performed with consent by a clinician digitally through a circular motion during a vaginal examination. If the cervical os is closed massage of the cervix will be accepted.
15817310|NCT04307173|Drug|KBL693|"Part 1: 680 mg/day of KBL693 or Placebo;
~Route of Administration: Oral"
15817311|NCT04307173|Drug|KBL693|"Part 2: 6800 mg/day of KBL693 or Placebo;
~Route of Administration: Oral"
15817312|NCT04307160|Procedure|Bilateral lateral rectus recession|All patients will undergo bilateral lateral rectus recession according to standard tables. In the younger age group, the amount of lateral rectus recession will be reduced by 0.5 mm. in those with inferior oblique overaction, inferior oblique recession will be performed
15817313|NCT04307147|Drug|Capecitabine|Oral capecitabine (at a dose of 1250 mg/m², twice per day, on days 1 to 14) every 3 weeks for 4 cycles.
15817314|NCT04307147|Drug|Vinorelbine|Intravenous vinorelbine (at a dose of 25 mg/m² on day 1, day 8) every 3 weeks for 4 cycles.
15817315|NCT04307134|Drug|Inotuzumab ozogamicin|R/R ALL who treated with Inotuzumab ozogamicin
15817316|NCT04307108|Device|Magic Glass|MAGIC-GLASS is a VR-based home system for stroke rehabilitation, developed by Ulster University (UK) in collaboration with Tech4Care srl (Italy) and miThings AB (Sweden) in the context of the EU-funded Project Magic (grant agreement No 687228). It includes a number of mini-games grounded on rehabilitation paradigms such as mirror therapy [29] and can adapt to the capability of a person. In addition, the games will include an automatic coaching system for giving feedback both on rehabilitation results (e.g. achievement of exercise goals) and performance (during the exercise itself, the system will give real time advice on the execution of the exercise).
15817317|NCT04307082|Drug|[14C]-Ibrexafungerp|Radio-labeled Ibrexafungerp, single dose.
15817318|NCT04307069|Drug|Oxytocin|The drug wil be adminisrate for augmentation of labor at admission.
15817319|NCT04307056|Procedure|Radical Prostatectomy|The surgical approach can be open or laparoscopic. The procedure begins with lymph node dissection for the intermediate risk groups (PSA > 10 ng/mL and/or presence of grade 4 Gleason score). Total prostatectomy includes removal of the seminal vesicles. It can preserve 1 or 2 neurovascular bundles, depending on the cancer stage and/or the choice expressed by the patient. The vesicourethral suture is either a running or interrupted suture, and there is drainage by a bladder catheter for at least 5 days.
15817320|NCT04307056|Procedure|High Intensity Focused Ultrasound (HIFU) Treatment|The treatment with High Intensity Focused Ultrasound (HIFU) evaluated in this study will be delivered by 2 types of medical devices currently available on the market, Ablatherm® and Focal One®. They are both computer-controlled and provided with an endo-rectal probe with integrated ultrasound, enabling planning and the monitoring of treatment of localized prostate cancer in realtime.
15817321|NCT04307030|Diagnostic Test|Heart Auscultation and Echocardiography|Heart auscultation will be done by cardiovascular pediatrician and echocardiography by echocardiologist
15817322|NCT04307017|Other|StimaWell®EMS|The StimaWell®EMS device is a 12-channel medium-frequency device with modulated low frequency using a high-tech stimulation suit for the trunk and strap electrodes for the arms and legs allowing whole-body stimulation. The device has 70 preprogramed training programs based on goals (e.g., strengthening, endurance training, aerobic training).
15817323|NCT04307004|Other|Unattended blood pressure measurement|Participants will have their blood pressure measured three times with an automated blood pressure monitor with a technician not present in the room.
15817324|NCT04307004|Other|Attended blood pressure measurement|Participants will have their blood pressure measured three times with an automated blood pressure monitor with a technician present in the room.
15817325|NCT04307004|Other|Ambulatory blood pressure monitoring|Participants will have their blood pressure measured every 30 minutes over 24-hours using an ambulatory blood pressure monitor.
15817326|NCT04307004|Other|Home blood pressure monitoring|Participants will have their blood pressure measured three times overnight while they are asleep using a home blood pressure monitor.
15817327|NCT04306991|Device|Auscultation using an electronic stethoscope (EKO CORE 4)|"Auscultation using an electronic stethoscope (EKO CORE 4). Record of at least 3 cardiac cycles.
~Measurement of cardiac output using echocardiography."
15817328|NCT04306978|Other|CareLink Express RM system|CareLink Express remote monitoring system consists of implantable pacemaker CareLink Express station for implanted Medtronic cardiac devices and provides remote data transmissions
15817329|NCT04306978|Other|Standard follow-up|Follow-up will be provided according to the standard guidelines (HRS/EHRA Expert Consensus on the Monitoring of Cardiovascular Implantable Electronic Devices (CIEDs): Description of Techniques, Indications, Personnel, Frequency and Ethical Considerations; 2008)
15817330|NCT04306965|Drug|Apremilast|30 mg BID
15817331|NCT04306952|Behavioral|Brief MBI|The brief MBI consists of four weekly group sessions that are two hours each and one all day mediation retreat. The rationale for testing the short MBI is to evaluate a low-dose (8 hours of contact) MBI that optimizes cost-effectiveness and minimizes patient burden.
15817332|NCT04306952|Behavioral|Standard MBI|The standard MBI consists of eight weekly group sessions that are approximately two hours each and one all day meditation retreat. The length of this package is based on the standard length of MBSR as an 8-week program. The rationale for testing the standard MBI is to provide a comparison to a dose (16 hours of contact) that is most similar to the length of MBSR and has the fewest modifications, making it easier to train MBI providers.
15817333|NCT04306952|Behavioral|Extended MBI|"The extended MBI consists of four weekly group sessions followed by four group sessions every other week over the course of 12 weeks. Each group session will be two hours. The group sessions will be identical to the standard package except for the timing (every other week) of the last four sessions. In addition to the group sessions, the MBI provider will offer office hours in between the bi-weekly group sessions, where participants will be able to schedule individual sessions with the MBI provider to discuss questions and troubleshoot their mindfulness practice. In addition, participants will receive an all-day meditation retreat, similar to the other conditions. The rationale for testing the extended MBI is to optimize acceptability and uptake based on the investigator's preliminary data by allowing for a slower, extended pace of learning mindfulness practices with an opportunity to have individual discussions with the instructor (16 hours of contact + individual office hours)."
15817334|NCT04306939|Other|venipuncture|Research blood collection is also an option via venipuncture if the subject is not scheduled for clinical testing. This will also be limited to 21cc of blood, up to 4 time a year, and with the approval of the attending physician.
15817335|NCT04306939|Behavioral|Questionnaires|PROMIS-43 Profile, PROMIS-29 Profile, Global Health Scale and Hospital Anxiety and Depression Scale (HADS). Additional assessments can be approved and administered per specific disease sub-category.
15817336|NCT04306939|Other|Additional Sample Collections|We may also contact subjects to request additional blood, saliva, cheek swab, hair, urine, or stool with their permission. This will be limited to no more than 4 teaspoons of blood and will happen no more than 4 times per year.
15817337|NCT04306926|Drug|TQB2450|TQB2450 1200mg administered IV on Day 1 of each 21-day cycle.
15817338|NCT04306926|Radiation|SBRT|Give according to the location of the lesion and clinical condition.
15817339|NCT04306913|Drug|Esmolol|esmolol 250 mg in cardioplegia solution every 25 minutes
15817340|NCT04306913|Drug|Potassium Cardioplegic Solution|15 meq potassium added to cardioplegia solution
15817341|NCT04306900|Combination Product|TTX-030, budigalimab and mFOLFOX6|Dose and schedule per protocol
15817342|NCT04306900|Combination Product|TTX-030, budigalimab and docetaxel|Dose and schedule per protocol
15817343|NCT04306900|Combination Product|TTX-030 and mFOLFOX6|Dose and schedule per protocol
15817344|NCT04306900|Combination Product|TTX-030 and budigalimab|Dose and schedule per protocol
15817345|NCT04306900|Combination Product|TTX-030, budigalimab, nab-paclitaxel and gemcitabine|Dose and schedule per protocol
15817346|NCT04306900|Combination Product|TTX-030 and pembrolizumab|Dose and schedule per protocol
15817347|NCT04306900|Combination Product|TTX-030, nab-paclitaxel and gemcitabine|Dose and schedule per protocol
15817348|NCT04306900|Combination Product|Budigalimab and mFOLFOX6|Dose and schedule per protocol
15817349|NCT04306887|Drug|TQ-B3101 capsule|Escalating doses starting at 200 mg bid.
15817350|NCT04306874|Dietary Supplement|Ensure Max Protein|Liquid shake with 30 g protein per serving
15817351|NCT04306861|Diagnostic Test|MRI|Baseline contrast-enhanced MRI and 2 follow-up contrast-enhanced MRIs (mid-treatment and treatment completion)
15817352|NCT04306848|Device|Temporary Continuous Glucose Monitoring System|This is a feasibility study evaluating the potential to utilize a continuous glucose monitoring system (CGMs) on a temporary basis, during participation in an intensive therapeutic lifestyle medicine program, to help improve the compliance with healthy lifestyle changes for people with Type 2 diabetes (T2DM) and prediabetes (PD).
15817353|NCT04306835|Behavioral|Cognitive behavioural therapy for insomnia|a technique for treating insomnia without medications
15817354|NCT04306809|Behavioral|Internet-delivered ACT for PTSD and chronic pain|The participants will go through an active internet-based ACT treatment focused on education about PTSD, value-based exposure for the traumatic memory and avoided situations, and behavior change through exercises targeting the processes mindfulness, cognitive defusion and acceptance. The treatment is delivered on a safe internet platform. Participants have planned telephone contact with their assigned psychologist 3 times during the program and can also contact their psychologist via a message system in the platform and expect answer within 48 hours.
15817355|NCT04306796|Device|3D printed splints|3D printed made to measure splints
15817356|NCT04306796|Device|Thermoplastic splints|thermoplastic splints individually adjusted by occupational therapists
15817357|NCT04306783|Other|In-home sensor monitoring|-Installed and maintained by Foresite Healthcare
15817358|NCT04306770|Other|OPTIMUM programme|"OPTIMUM programme encompass of telehealth service to support the patient. Study participants will be given devices (Bluetooth-enabled blood pressure machine, weighing scale and glucometer) to monitor their parameters at home. Care team will use the Phillips Vital Health to perform tele-monitoring, tele-management (individualized on-line health coaching and timely interventions), and to deliver education content."
15817359|NCT04306757|Device|Evone|Airway ventilation device
15817360|NCT04306757|Device|Primus|Airway ventilation device
15817361|NCT04306731|Dietary Supplement|Nanotechnology Structured water Magnalife|Nanotechnology Structured water Magnalife is drinking water that has been modified using nanotechnology to change the structuring of water molecules
15817362|NCT04306731|Drug|Trimethoprim|Antibiotic
15817363|NCT04306731|Dietary Supplement|Ordinary bottled drinking water|Placebo
15817364|NCT04306718|Procedure|membrane peeling|ERM and ILM are peeled routinely during surgery
15817365|NCT04306705|Drug|Tocilizumab|Administered as an intravenous infusion.
15817366|NCT04306705|Other|Standard of care|Standard of care therapy per local written policies or guidelines and includes balancing of electrolytes and acid-base, the provision of enteral or parenteral nutrients support, antibiotics therapy, oxygen therapy and noninvasive ventilation.
15817367|NCT04306705|Procedure|Continuous renal replacement therapy|Catheter insertion site is femoral vein.
15817368|NCT04306692|Drug|Myo-inositol|2 x 1 bag per day, per os (subjects can take myo-inositol during the meal but it is not obliged).
15817369|NCT04306692|Drug|Clomiphene Citrate|"Each tablet contains 50 mg of clomiphene citrate which means 33,9 mg of clomiphene. Other constituents are sucrose, lactose monohydrate, corn starch, pregelatinized starch, yellow iron oxide (E172) and magnesium stearate (E470b).
~Dosing: 1 tablet per day from cycle day 3 until 7 (extremes included), stepping up until a maximum dose of 3 tablets per day for 5 consecutive days."
15817370|NCT04306679|Other|Animation clips|The first animation clip focuses on the importance of pain assessment introduce three pain scales (categorical, NPS and faces) followed by explanations on their properties and on the appropriate way to use them.The second movie was aimed to provide an opportunity to implement the new knowledge in case studies
15817371|NCT04306679|Other|Instructions|Routine preoperative preparations, which included a section on pain assessment instructions.
15817372|NCT04306666|Other|Regional anesthesia|Injection of local anesthetics by a regional anesthesia named Walant block (Wide Awak Local anesthesia No Tourniquet)or by axillary brachial plexus block.
15817373|NCT04306653|Drug|ACTH|patients with acute gout will receive 100 IU ACTH IM
15817374|NCT04306653|Drug|Betamethasone|patients with acute gout will receive 6 mg of betamethasone
15817375|NCT04306640|Other|Sagittal Cervical Posture Corrective Orthotic Device|The subjects in the traction group will receive the deneroll extension traction. The subjects will be asked to lie supine on the ground with their legs straight, upper arms by their sides and forearms gently folded across their trunk. The therapist will place the apex of the denneroll either in the mid cervical region or the lower cervical region depending on the apex of cervical curvature deformity of each subject. Initially, participants begin with three minutes of sustained denneroll extension traction and progressed to the goal of 20 min per session with one to two additional minutes per session
15817376|NCT04306627|Drug|Perindopril/Amlodipine and Perindopril/Amlodipine/Atorvastatin treatment|comparative antihypertensive antilipidemic treatment assessment on carotid intima media thickness in both study groups
15817377|NCT04306614|Procedure|Endobronchial Ultrasound guided Transbronchial Fine Needle Aspiration|Bronchoscopic procedure to allow for sampling mediastinal lymphadenopathy or proximal lung tumours under real-time ultrasound guidance.
15817378|NCT04306601|Device|Low-Intensity Focused Ultrasound|Low-intensity focused ultrasound brain stimulation using focused ultrasound system (NS-US100; NEUROSONA Co. Ltd., Seoul, Korea)
15817379|NCT04306588|Other|Exercise|Participants are undergoing a 12 weeks tele-rehabilitation program.
15817380|NCT04306575|Other|Trans-venous lead extraction|Patients with a dysfunction or infection of a cardiac pacemaker or a defibrillator are indicated for extraction of these devices, so lead extraction is done transvenously to remove these leads
15817381|NCT04306562|Dietary Supplement|enteral nutrition supplement|enteral nutrition supplement to reach a target of total dietary protein intake of 1.5 g/kg/day for at least 14 days from a preanesthetic clinic visit to a day of surgery.
15817382|NCT04306549|Other|Bulk-Fill and Microhybrid Composite Resins|Clinical Comparison of Composite Restorations (Two Bulk-Fill and one Microhybrid Composite Resin) to the USPHS Criterias
15817413|NCT04306263|Dietary Supplement|Breastfeeding arm|Infants exclusively or predominantly breastfed (>75%).
15817383|NCT04306536|Dietary Supplement|Fortifit®|Best local diet + two servings (40 grams each) of powder (Fortifit®; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers.
15817384|NCT04306523|Other|Observation|4 months: observation of infant feeding behavior, behavior/temperament; bio-specimen collection; body composition, sucking intensity/frequency, activity intensity/frequency; maternal reports of feeding and behavior/temperament; maternal biospecimen. 6 month: behavior/temperament assessment, physical activity, and body composition. 12 month: Feeding behavior, behavior/temperament assessment, physical activity, and body composition. 24 month: maternal reports of children's eating behavior, behavior/temperament.
15817385|NCT04306510|Procedure|Blood samples for immunoglobulins|Following an injection of TEGSEDI as prescribed by their physician per the product label, patients will have additional blood tests at 1, 2, 4, 8 and 24 hours post injection for immunoglubulins at a clinic visit every 4 months for up to 2 years.
15817386|NCT04306510|Procedure|Blood samples for inflammatory markers|Following an injection of TEGSEDI as prescribed by their physician per the product label, patients will have additional blood tests at 1, 2, 4, 8 and 24 hours post injection for inflammatory markers at a clinic visit every 4 months for up to 2 years.
15817387|NCT04306510|Procedure|Blood samples for anti-drug antibodies|Patients taking TEGSEDI as prescribed by their physician per the product label, patients will have additional blood samples for anti-drug antibodies at various time-points as indicated in the event of hypersensitivity reactions.
15817388|NCT04306497|Drug|TCM prescriptions|TCM prescriptions1:Take decocted or granule, one dose a day; TCM prescriptions2:Take decocted or granule, one dose a day.
15817389|NCT04306484|Diagnostic Test|FDOPA-TEP|FDOPA-TEP performed as part of the normal management of a suspected brain tumour
15817390|NCT04306471|Drug|Evolocumab 140mg/mL Injector 1milliliter (mL) Pen x 3 for a monthly dose of 420 mg for 12 months.|The study subjects randomized to the treatment study arm will receive monthly subcutaneous injections of evolocumab 420 mg in the abdomen, thigh or upper arm. The study drug (evolocumab) prefilled injector pens are to be provided by Amgen.
15817391|NCT04306471|Other|Placebo 1 milliliter (mL) Injector Pen x 3 monthly for 12 months|The study subjects randomized to the control study arm will receive monthly subcutaneous injections of placebo 1 mL x 3 in the abdomen, thigh or upper arm. The study placebo prefilled injector pens are to be provided by Amgen.
15817392|NCT04306458|Procedure|Minimally invasive esophagectomy|Conventional minimally invasive esophagectomy
15817393|NCT04306458|Device|daVinci Xi system|robot assisted minimally invasive esophagectomy
15817394|NCT04306445|Device|GF-IGB: Obalon Balloon|The Obalon balloon, contained in a capsule and attached to a thin catheter, is swallowed by the patient in a standing position. Once the two-step verification of balloon passage into the stomach by both fluoroscopy and pressure reading, the balloon is inflated to a volume of 250 ml with a nitrogen-mix gas and the catheter is removed. The process is repeated at week 2 for the second balloon and between weeks 4-8 for the third balloon based on patient preference. All patients are given an individualized calorie prescription by a registered dietitian for a goal of up to 2 pounds of weight loss per week. The balloons are removed endoscopically 6 months after placement of the first balloon. Patients also attend monthly virtual individual diet coaching and monthly virtual group behavior coaching sessions both delivered by a registered dietitian for twelve months focused on long-term behavior change, 6 months while the balloons are in place and six months after the balloons are removed.
15817395|NCT04306445|Dietary Supplement|Medically Supervised Meal Replacement Program: My New Weigh|Patients are given an individualized calorie prescription by a registered dietitian for a goal of 2 pounds weight loss per week. Patients are seen in a group-based program once a week focused on long-term behavior change and use meal replacements for a nutritionally balanced very low-calorie diet for 20 weeks. 4-5 meal replacements are consumed per day. If only 4 meal replacements are consumed, individuals eat 3 servings of vegetables and 2 servings of fruit per day as well.
15817396|NCT04306432|Other|Cognitive tests and Patient Reported Outcomes|Each patient will undergo cognitive tests and questionnaires
15817397|NCT04306406|Other|Raspberries|Red raspberry smoothies drink
15817398|NCT04306393|Drug|Nitric Oxide Gas|"80 ppm of inhaled nitric oxide for 48 hours, followed by 40 ppm, followed by weaning before stop.
~Weaning criteria: maintenance of a PaO2/FiO2 ratio >/= 300 for at least 24 hours consecutively."
15817399|NCT04306380|Other|no intervention, database study|data collection from EMR for database
15817400|NCT04306367|Drug|Pembrolizumab|200 mg
15817401|NCT04306367|Drug|Olaparib|300 mg
15817402|NCT04306354|Drug|Oxytocin nasal spray|Oxytocin nasal spray 24 UI twice daily as adjunctive treatment to conventional treatment during 10 days of detoxification of crack cocaine
15817403|NCT04306354|Drug|placebo nasal spray|Nasal spray with placebo solution (2% odor-generating propolis essence + the same vehicle as intra-nasal oxytocin: 0.05% citric acid, 0.9% sodium chloride, 1% glycerol, 0.54% disodium phosphate, 0.2% methylparaben + propylparaben, 1% sorbitol, 80% water) twice daily as adjunctive treatment to conventional treatment.
15817404|NCT04306341|Behavioral|real time fMRI neurofeedback|Participants will use real time feedback about their amygdala activity to learn to decrease amygdala activity.
15817405|NCT04306328|Device|Neurostimulation|Implantation of 2 multicontact cuff electrodes in the upper limb of patients with tetraplegia and control of the stimulation by contralateral shoulder movements
15817406|NCT04306315|Biological|Brodalumab|Brodalumab is an anti-IL-17 receptor antibody, which blocks the inflammatory effects of IL-17 in the skin.
15817407|NCT04306302|Biological|ExPEC10V|Participants will receive a single IM injection of ExPEC10V.
15817408|NCT04306302|Biological|Placebo|Participants will receive single IM injection of matching placebo.
15817409|NCT04306289|Device|transcranial direct current stimulation|Transcranial direct current stimulation (tDCS) is a noninvasive technique of neuronal modulation that has been used in different neurological conditions, neuropathic pain.
15817410|NCT04306276|Drug|Dienogest 2 MG|Three-month treatment with DNG (2 mg daily; Visanne, Bayer Pharma, Germany) before IVF
15817411|NCT04306263|Dietary Supplement|Enriched infant formula|Infant formula enriched with dairy ingredients: osteopontin, prebiotics and probiotics
15817412|NCT04306263|Dietary Supplement|Standard formula|Infants receiving a standard infant formula.
15817414|NCT04306250|Procedure|Apical prolapse fixation - anterior access|The surgery is done in anterior access
15817415|NCT04306250|Procedure|Apical prolapse fixation - posterior access|The surgery is done in posterior access
15817416|NCT04306237|Drug|IMB-1018972|IMB-1018972 200 mg tablet for oral administration
15817417|NCT04306237|Drug|Placebo oral tablet|Matched placebo tablet for oral administration
15817418|NCT04306224|Biological|IMC-002|IMC-002 blocks the interaction between CD47 and SIRPα.
15817419|NCT04306211|Device|SuperNO2VA|SUPERNO2VA is nasal PAP device for oxygen delivery
15817420|NCT04306198|Device|Osteosynthesis with Trochanteric Fixation Nail (TFN), using a lag screw as a proximal fixation.|Closed reduction and surgical stabilization of intertrochanteric hip fractures using Trochanteric Fixation Nail (TFN), with lag screw as proximal fixation
15817421|NCT04306198|Device|Osteosynthesis with Trochanteric Fixation Nail (TFN), using a helical blade as a proximal fixation.|Closed reduction and surgical stabilization of intertrochanteric hip fractures using Trochanteric Fixation Nail (TFN), with helical blade as proximal fixation
15817422|NCT04306185|Procedure|OVARIAN FRAGMENTATION|BILATERAL OVARIAN CORTEX FRAGMENTATION USING LAPAROSCOPIC SCISSORS
15817423|NCT04306172|Other|An US Readmission Risk Prediction Model|Logistic regression model that predicts the risk of all-cause unplanned readmissions developed by the privately held healthcare software company EPIC.
15817424|NCT04306172|Other|LACE+ score|The LACE+ score is a point score that can be used to predict the risk of post-discharge death or urgent readmission. It was developed based on administrative data in Ontario, Canada.
15817425|NCT04306172|Other|SQLAPE model|The readmission risk model (Striving for Quality Level and analyzing of patient expenditures), is a computerized validated algorithm and was developed in 2002 to identify potentially avoidable readmissions.
15817426|NCT04306159|Procedure|Subcostal TAP|Subcostal transversus abdominis plane block
15817427|NCT04306159|Procedure|Modified RSB|Rectus Sheath Block under the guidance of surgical incision
15817428|NCT04306159|Other|General anesthesia|Traditional general anesthesia management
15817429|NCT04306146|Drug|CAD-9303|Capsules filled with CAD-9303 from 3 mg up to 1000 mg.
15817430|NCT04306146|Drug|Placebos|Capsules
15817431|NCT04306133|Procedure|PENG block|After performing spinal anesthesia, PENG block with 20 mL of 0.375 % Ropivacaine will be executed as described by Giron-Arongo et al with a low frequency curvilinear probe. A 22G 80 mm needle (Stimuplex Ultra 360, Braun ) will be used.
15817432|NCT04306133|Procedure|Wound Infiltration|At the end of operation, the surgeon will perform wound infiltration with 20 mL of 0.375 % Ropivacaine.
15817433|NCT04306120|Other|Traditional Rehabilitation Therapy|The protocol included range of motion, ambulation, endurance, strengthening, reconditioning exercise, and home program education according to therapists' plans and the patients' ability.
15817434|NCT04306107|Device|Prone position during non-invasive respiratory support|HFNC and NIV application with patient on prone position
15817435|NCT04306081|Drug|Evolocumab 140 mg/mL Subcutaneous Injection 1 milliliter (mL) pre-filled injector Pen x 3 for a monthly dose of 420 mg for 6 months.|The study subjects randomized to the treatment study arm will receive monthly subcutaneous injections of evolocumab 420 mg in the abdomen, thigh or upper arm. The study drug (evolocumab) prefilled injector pens are provided by Amgen
15817436|NCT04306081|Other|Placebo 1milliliter (mL) Subcutaneous Injection pre-filled injector Pen x 3 monthly for 6 months.|The study subjects randomized to the treatment study arm will receive monthly subcutaneous injections of Placebo in the abdomen, thigh or upper arm. The Placebo prefilled injector pens are provided by Amgen
15817437|NCT04306068|Other|Plyometric protocol|"Each session will last 20 minutes, with 2 sessions a week, over a period of 5 weeks. The intervention will last 20 minutes, which consists of a 4-station circuit.
~Exercise 1: jump on the rope, with your feet together at a moderate pace. Exercise 2: In standing with hands on the hip and hip flexion (one foot in front). Knee flexion and dorsal ankle flexion, with straight trunk. Alternate legs.
~Exercise 3: box jump (jump on the box with both feet at the same time). Exercise 4: depth jumps from box to antoher box (jump on the box with both feet at the same time and when falling, immediately jump to the other box).
~1 minute with 30 seconds between sets."
15817438|NCT04306055|Other|Questionnaire with precaution information|Ever blood donors in this group would receive a questionnaire which includes some information about how donors can donate safely and how blood center will protect the blood donors during the epidemic of COVID-19.
15817439|NCT04306055|Other|Experimental: Questionnaire without precaution information|Ever blood donors in this group would receive a questionnaire which dose not include the information above.
15817440|NCT04306042|Drug|Nivolumab or Pembrolizumab|Nivolumab or Pembrolizumab
15817441|NCT04306029|Other|Postpartum Family Planning Package|"Postpartum Family Planning Package, which consists of provider education on contraceptive delivery in the immediate postpartum period and promotion of the WHO MEC/PFP Compendium mobile application."
15817442|NCT04306016|Other|Sensory stimulation|Sensory stimulation can be formed in different aspects, and the most important ones are visual stimulation and auditory stimulation. Visual stimulation interventions involved providing a calendar, clock or familiar objects such as photographs of family caregivers; while auditory stimulation included calling the name of patients, helping to orientate the time and location, introducing hospital information, the ICU surrounding and treatment, and communicating with patients, who could not talk due to artificial airway, through a blackboard and use of gestures.
15817443|NCT04306003|Other|ERAS pathway|See ERAS pathway arm description.
15817444|NCT04306003|Other|Standard Perioperative Care|See control arm description.
15817445|NCT04305990|Device|Demand-driven delivery method|The gas delivery device is set to the demand-driven setting. Patients must inspire through their nose to trigger the flow of gas.
15817446|NCT04305990|Device|Free-flow delivery method|The gas delivery device is set to a free-flow setting. Gas flows through the system at a rate determined by the operator. Standard flow rate is 6 liters per minute. Patients do not need to inspire through their nose to trigger the flow of gas.
15817447|NCT04305977|Behavioral|WAVE-TW|The WAVE-TW open pilot trial of the intervention consists of 5 sessions conducted individually with each part participant. Each session lasts approximately 30-50 minutes. The first session will be the LifeSteps Adherence session that focuses on cognitive-behavioral and problem-solving techniques to promote adherence. The next four sessions will be dedicated to trauma writing.
15817448|NCT04305964|Device|Nastent® (a distally perforated soft silicon nasal tube)|Insertion of the Nastent® to nostril during sleep hours
15817449|NCT04305964|Diagnostic Test|Polygraphy with WatchPAT™ 300|WatchPAT™ 300 is an innovative diagnostic Home Sleep Apnea Test (HSAT) that utilizes the proprietary Peripheral Arterial Tone signal (PAT™) to enable simple, accurate and reliable sleep apnea testing.
15817450|NCT04305951|Procedure|Comprehensive acupuncture therapy (CAT) (Hwato®/ Dongbang®)|"CAT will be conducted for 2 sessions per week for 12 consecutive weeks.
~The following 15 body acupoints with only manual stimulation will be used: Shen-Men (HT7), He-Gu (LI4), Wai-Guan (TE5), Zu-San-Li (ST36), Feng-Long (ST40) and San-Yin-Jiao (SP6) in two sides, and Zhong-Wan (CV12), Guan-Yuan (CV4), and Shui-Gou (GV26) in midline. Electrical stimulation will be conducted on six pairs of frontal acupoints located on the frontal, parietal, and temporal scalp areas.
~Disposable acupuncture needles (0.30 mm in diameter and 25-40 mm in length) will be inserted at a depth of 10-30 mm perpendicularly or obliquely into acupoints. Manual manipulation will be carried out for all acupoints to evoke needling sensation. Electrical stimulation is additionally delivered on the 6 pairs of the frontal acupoints. Each session of treatment will last 30 min."
15817451|NCT04305951|Procedure|Comfy Acupressure for the Elderly (CAE)|"CAE intervention will be conducted for 3 times per week for 12 consecutive weeks.
~CAE consists of 12 steps which need about 15 min to complete and mainly concentrates on the acupoints on face, head, neck, and shoulder. The detailed CAE Operation Guide will be provided for the provider and the video demonstration is accessible at https://www.youtube.com/watch?v=pAqNIZPKmnM."
15817452|NCT04305938|Diagnostic Test|Minimally invasive and non-invasive blood analyte measurement|Rapid point-of-care minimally invasive blood analyzer consisting of a spectrometer and a computer loaded with Kaligia software that controls the data acquisition and signal processing to interpret blood analyte measurement.
15817453|NCT04305925|Device|Focal Laser Ablation|Orion system to deploy and monitor thermal energy in cancerous regions of the prostate, identified by MRI and confirmed by targeted biopsy. MRI guidance will be achieved by MRI/ultrasound fusion, overlaying stored MRI images upon real-time ultrasound images. Interstitial laser treatments would be achieved by inserting the fiber into the cancerous regions guided by the Artemis image-fusion device. Applications of laser energy up to 15 watts of power will be used to treat the target region.
15817454|NCT04305912|Device|somofilcon A|Subjects will be randomized to wear somofilcon A daily disposable lenses.
15817455|NCT04305912|Device|verofilcon A|Subjects will be randomized to wear verofilcon A daily disposable lenses.
15817456|NCT04305899|Drug|BMS-986165 Tablet formulation 1|Specified dose on specified days
15817457|NCT04305899|Drug|BMS-986165 Tablet formulation 2|Specified dose on specified days
15817458|NCT04305886|Other|Discussion Guide|Written list of prompts to facilitate discussion
15817459|NCT04305860|Dietary Supplement|Modified starch without flavoring|Each patient of this group receives the thickener during three days of hospitalization
15817460|NCT04305860|Dietary Supplement|Mofidied starch with Bi1 aromas|Each patient of this group receives the thickener and 5 flavorings during three days of hospitalization
15817461|NCT04305860|Dietary Supplement|Xanthan gum without flavoring|Each patient of this group receives the thickener during three days of hospitalization
15817462|NCT04305860|Dietary Supplement|Xanthan gum with Bi1 aromas|Each patient of this group receives the thickener and 5 flavorings during three days of hospitalization
15817463|NCT04305847|Other|perioperative satisfaction assessment|Satisfaction assessment at 24 and 48 hours post operatively by self-administered survey questionnaire based on different scales: Evan-LR, Net Promotor Score, Satisfaction score.
15817464|NCT04305834|Drug|Abemaciclib|Given PO
15817465|NCT04305834|Other|Questionnaire Administration|Ancillary studies
15817466|NCT04305821|Other|Dosage of S100β protein|Dosage of S100β protein
15817470|NCT04305782|Device|Release/Relock Socket - In Lab|The participants will operate the test socket in one of two test conditions: (1) pin re-lock before panel re-lock and (2) panel re-lock before pin re-lock. Participants will test each of the two conditions in a random order, in lab, following a structured protocol. Tests will determine if the order of the re-lock mechanisms influences changes in limb volume.
15817471|NCT04305782|Device|Release/Relock Socket - Out of Lab|The participants will operate the test socket in one of two test conditions: (1) pin re-lock before panel re-lock and (2) panel re-lock before pin re-lock. Participants will test each of the two conditions in a random order, out of lab, with no structured protocol. Tests will determine if the order of the re-lock mechanisms changes participant experience.
15817472|NCT04305782|Device|Release/Relock Socket & Control|The participants will operate the test socket in one of two test conditions: (1) release/relock mechanisms enabled and (2) release/relock mechanisms disabled. Participants will test each of the two conditions in a random order, out of lab, with no structured protocol. Tests will determine how the novel release/relock mechanisms compare against traditional socket release methods.
15817473|NCT04305769|Drug|Alanyl-glutamine|The study agent is AQ, a dipeptide with a glutamine amino group joined to an alanyl residue. It has the following chemical structure: C8H15N3O4. It is a non-animal product available in the form of white crystals or crystalline powder. It is odorless, tasteless, stable and highly soluble.
15817474|NCT04305756|Drug|Enoxaparin|Low molecular weight heparin
15817475|NCT04305743|Drug|OnabotulinumtoxinA 100 UNT|Intradetrusor onabotulinumtoxin A is administered cystoscopically with 100 unit dose given as either 5 or 20 injections in a single procedure based on the arm the participant is randomized into.
15817476|NCT04305730|Behavioral|Use of a pedometer following surgery|Subjects in the study group will receive a pedometer with graduated step count goals as discussed in arm description.
15817477|NCT04305730|Behavioral|Standard of care|Subjects in the control group will be counseled on the importance of ambulation during their pre-operative visit.
15817478|NCT04305717|Device|ReDS-guided strategy|A discharge scheme based on specific target value given by the device
15817479|NCT04305691|Drug|Ixazomib Citrate|Given PO
15817480|NCT04305691|Other|Quality-of-Life Assessment|Ancillary studies
15817481|NCT04305691|Other|Questionnaire Administration|Ancillary studies
15817482|NCT04305678|Drug|Mepolizumab|Mepolizumab (Nucala) 400 mg SC every 4 weeks x 24 weeks
15817483|NCT04305652|Other|The Progressively Lowered Stress Threshold Model|PLST is a conceptual model for reducing behavioral symptoms in individuals with dementia. The PLST model provides the foundation for a psychoeducational intervention that assists formal and informal caregivers in understanding behaviors and planning care for individuals with dementia. If the model is to be applied at home, at least three home visits are made in line with the listed principles. While making a diagnosis during the first home visit, a maintenance plan for the problems is created in other home visits and the caregiver is trained to implement the care plan. After the home visits, the process is carried out by providing counseling through telephone calls or face-to-face interviews when necessary.
15817484|NCT04305626|Device|Endovascular treatment of intracranial aneurysms|Endovascular treatment of intracranial aneurysms with flow diversion.
15817485|NCT04305613|Other|Chemoradiation|Patients will be treated with definitive concurrent chemoradiation with curative intent as determined by their medical and radiation oncologists. We will consider timing of initiation and discontinuation, type, and cumulative dose of platinum based chemotherapy. We will also consider dose, duration, and type of immunotherapy. Radiation therapy will be delivered via proton or proton therapy. Our primary radiation therapy dose-volume exposures are whole heart volumetric dose. As secondary exposures, we will comprehensively define radiation therapy dose parameters to the right ventricle, entire left ventricle, left ventricle segments, coronary arteries, and mean heart dose.
15817486|NCT04305587|Drug|PF-07081532|Investigational Drug once daily for up to 42 days; multiple ascending dose design.
15817487|NCT04305587|Other|Placebo|Placebo once daily for up to 42 days.
15817488|NCT04305587|Drug|Clopidogrel|Part B may include a drug-drug interaction study using open-label clopidogrel. Clopidrogrel may be given as two single doses of 75 mg administered on day -2 and day 41.
15817489|NCT04305574|Behavioral|Use of social media during COVID-19|Participants' self-reported use of an official WhatsApp channel to receive and share news about COVID-19
15817490|NCT04305561|Procedure|Contrast-enhanced ultrasound|"Ultrasound contrast agent: Stabilized sulfur hexafluoride microbubbles (SonoVue®, Bracco).
~An 18 G needle will be placed in an antecubital vein and directly attached to a three-way stopcock with an extension tube.
~The SonoVue® will be prepared and shaken shortly before injection in accordance with the instructions provided in the product information leaflet.
~The patient will be injected with 1.2 ml SonoVue® at a pace of 1-2 ml/s using the 180 degree straight-flow channel of the three-way stopcock, directly followed by a 10 ml bolus of sodium chloride 9 mg/mL (0.9%) injected into the 90 degree channel of the three-way stopcock at a pace of approximately 2 ml/s.
~A full examination will typically require one to two injections of 1.2 ml of SonoVue® (one injection per suspected parathyroid adenoma)."
15817491|NCT04305548|Drug|Trabectedin|Treatment with trabectedin: 1.5 mg/m² - 1.3 mg/m² (at investigator's discretion, with a top-dose of 2.6 total mg per cycle), given in 24-hour continuous infusion
15817492|NCT04305535|Dietary Supplement|Peptidic+Probiotic|"Oligomeric oral nutritional supplement (Bi1 peptidic) and a mix of probiotics
~Bifidobacterium animalis subsp. lactis BPL1,
~Lactobacillus rhamnosus BPL15,
~Lactobacillus rhamnosus CNCM i-4036
~Bifidobacterium longum ES1"
15817493|NCT04305535|Dietary Supplement|Peptidic+Placebo|Oligomeric oral nutritional supplement (Bi1 peptidic) and a placebo
15817494|NCT04305535|Dietary Supplement|Polymeric+Placebo|Polymeric oral nutritional supplement and a placebo
15817495|NCT04305522|Dietary Supplement|Probiotic 1|Probiotic mixture with maltodextrin as a carrier.
15817496|NCT04305522|Dietary Supplement|Placebo|Placebo comparator with maltodextrin as a carrier.
15817497|NCT04305522|Dietary Supplement|Probiotic 2|Probiotic mixture with maltodextrin as a carrier.
15817498|NCT04305509|Other|no intervention|no intervention
15817499|NCT04305496|Drug|Fulvestrant|Patients will be administered 500 mg (2 injections) on Day 1 of Weeks 1 and 3 of Cycle 1, and then on Day 1, Week 1 of each cycle thereafter
15817500|NCT04305496|Drug|Capivasertib|400 mg BD (2 tablets of 200 mg taken twice a day = total daily dose 800 mg) given on an intermittent weekly dosing schedule. Patients will be dosed on Days 1 to 4 in each week of a 28-day treatment cycle
15817501|NCT04305496|Drug|Placebo|Placebo to match 400 mg BD (2 tablets of placebo to match 200 mg taken twice daily = placebo to match total daily dose of 800 mg) given on an intermittent weekly dosing schedule. Patients will be dosed on Days 1 to 4 in each week of a 28-day treatment cycle
15817502|NCT04305483|Procedure|Laser Bleaching|Content; There are 35% hydrogen peroxide, potassium nitrate, sodium fluoride, sodium hydroxide, thickener, glycol derivative. The way of application; Gingival protection is applied. The gel is applied to the labial surfaces of the teeth with a thickness of 1-2 mm. The use of laser increases the effectiveness of the gel. Operator and patient use protective glasses during laser application. The gel shows its effectiveness in about eight minutes. Then the gel is removed with the help of saliva absorber. The procedure is repeated until the desired degree of whitening is achieved. Then it is checked with a color scale.
15817503|NCT04305483|Procedure|Chemical Bleaching|"Total Blanc Office Teeth Whitening System (H35) will be used as chemical whitening agent. Content; There are 35% hydrogen peroxide, thickener, plant extracts, amide, release agent, glycol, paint and water. Method of Application; Gingival protection is applied. A 1 mm thick layer of gel is applied to all of the labial surfaces of the tooth. The whitening agent remains on the tooth surface for 20 minutes. At the end of this period, the gel is removed with saliva absorber and the surface is cleaned with a moist gauze."
15817505|NCT04305457|Drug|Nitric Oxide|Nitric Oxide (NO) will be delivered together with the standard of care for a period of 20-30 minutes 2 times per day for 14 consecutive days from time of enrollment. Targeted No inhaled concentration will be maintained between 140 and 180 ppm. The gas will be delivered through a CPAP circuit ensuring an end-expiratory pressure between 2 and 10 cmH2O or through a non-rebreathing mask without positive end-expiratory pressure, depending on the clinical needs of the subject.
15817506|NCT04305444|Drug|DTRM-555|Oral once-daily administration
15817790|NCT04303026|Drug|Saline 0.9%|Placebo Group. Saline 0.9% 100 ml infusion
15817508|NCT04305418|Other|Mindfulness- Based Intervention|"Mindfulness- Based Intervention in a psychological intervention, based on mind- body connection.
~The protocol includes a 10- weeks program, with weekly group sessions of 2 hours and one all-day session after seven weeks. The intervention have standardized core elements consisting of different mental and physical mindfulness exercises: 1) body-scan exercises (paying close attention to all body parts, from the feet to the head), 2) mental exercises focusing one's attention on breathing, 3) physical exercises with focus on being aware of bodily sensations and one's own limits during the exercises, and 4) practicing being fully aware during everyday activities by using the breath as an anchor for attention. Essential to all parts of the program is developing an accepting and non-reactive attitude to what one experiences in each moment."
15817509|NCT04305405|Drug|Benralizumab|Dose will be stratified by body weight at screening: Patients will receive Dose 1 or Dose 2 of Benralizumab administered by SC injection at Day 0 and Weeks 4, 8, and 16, 24, 32, and 40.
15817510|NCT04305392|Drug|SHR4640|orally SHR4640
15817511|NCT04305379|Procedure|Augmented Bladder Neck Reconstruction|Augmented Bladder Neck Reconstruction including a Medial Umbilical Ligament Sling plus Intussusception
15817512|NCT04305379|Procedure|Standard Bladder Neck Reconstruction|Standard Bladder Neck Reconstruction with Intussusception Only
15817513|NCT04305366|Other|Tissue collection|Blood draw, Fine Needle Aspiration, Saliva Swab, Tumor/tissue sample
15817514|NCT04305353|Other|Diary (blank journal) plus PTSD psycho-education|A blank journal where a prospective account of a patient's ICU course (everyday events) can be documented by family members and healthcare providers
15817515|NCT04305353|Other|PTSD psycho-education alone|"We administered a pamphlet to patients with information regarding PTSD symptoms, potential psychiatric complications after discharge, and available mental health resources.
~References for our education include the following which are included in our references section: Jensen 2015, Jones 2010, Knowles 2009, Parker 2015, Wintermann 2015."
15817516|NCT04305340|Device|Myant SKIIN Device|"Supine position: Participant lays on a bed on their back for 5 minutes
~Sitting position: Participant sits on a chair for 5 minutes
~Standing position: Participant stands for 5 minutes.
~Exercise measurement: treadmill exercise test - the protocol entails increases of 0.5 mph every minute with zero change in the incline. Starting point would 1.5 mph. The test will be interrupted if the target heart rate of 190 beats per minute is reached or if symptoms and/or arrhythmias and ST depression would be observed. Patient will be monitor during recovery for 5 minutes.
~Cool-down: Participants cool-down for 5 minutes"
15817517|NCT04305327|Drug|Brodalumab|Solution for subcutaneous injection.
15817518|NCT04305327|Drug|Ustekinumab|Solution for subcutaneous injection.
15817519|NCT04305327|Drug|Placebo|The placebo solution is similar to the active brodalumab solution except that it does not contain any active substance.
15817520|NCT04305314|Other|PRI (Enhanced Recovery after surgery protocol)|Standard use of Spanish perioperative guidelines (PRI)
15817521|NCT04305275|Drug|SAGE-324|SAGE-324 oral tablet
15817522|NCT04305275|Drug|SAGE-324 Placebo|SAGE-324 matched placebo oral tablet
15817523|NCT04305262|Device|Wireless continuous vital parameter monitoring|The patients included in this study will have continuous, wireless monitoring of vital parameters during the first four days of acute admission
15817524|NCT04305249|Drug|ATG-017|Dosing will begin at 5 mg once a day (QD) ATG-017 as starting dose. A cycle of study treatment will be defined as 21 days.
15817525|NCT04305236|Drug|Abemaciclib|Given PO
15817526|NCT04305236|Drug|Fulvestrant|Given Intramuscularly
15817527|NCT04305223|Procedure|Dry Needling|Dry Needling is a treatment technique whereby a sterile, single-use, fine filament needle is inserted into the muscle to assist with decreasing pain and improving function through the release of myofascial trigger points (knots in the muscle).
15817528|NCT04305223|Other|Upper extremity stretching program|A standard home exercise program consisting of strengthening and stretching exercises for the upper quarter
15817529|NCT04305210|Drug|F-18 PMPBB3|In this study we will enroll 20 healthy controls, 20 amnestic mild cognitive impairment patients (aMCI), 20 mild-moderate dementia due to AD patients and 10 other dementia such as frontotemporal dementia patients. All of the subjects will receive 18F-PM-PBB3 tau PET scan, and 18F-flobetapir (AV-45) amyloid PET scan, brain magnetic resonance images and clinical evaluation.
15817530|NCT04305210|Drug|18F-florbetapir|18F-florbetapir
15817531|NCT04305197|Drug|ICP-022|Tablet, 50mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
15817532|NCT04305197|Drug|ICP-022|Tablet, 80mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
15817533|NCT04305197|Drug|ICP-022|Tablet, 100mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
15817534|NCT04305197|Drug|Placebos|Tablet, matched to ICP-022, once a day, oral, will be administered for 12 weeks in double-blind treatment period
15817537|NCT04305171|Procedure|non-surgical periodontal treatment|scaling and root planing, home care instruction
15817538|NCT04305158|Drug|Nitrous Oxide|Patient receiving nitrous oxide are evaluated for success of the procedure
15817542|NCT04305132|Device|Electroconvulsive therapy|Thymatron System IV electroconvulsive therapy device
15817543|NCT04305106|Drug|Bevacizumab|Bevacizumab 7.5mg/kg body weight + 0.9% NaCl 100ml, intravenous drip
15817544|NCT04305080|Other|Anodic oxidation|Abutments will undergo anodic oxidation process after etching with Hydrofluoric acid & Nitric acid mixture for 10 minutes for debridement in a bath of distilled water with citric acid for 5 minutes to turn the abutment collar into pink color. The stainless steel plate will be connected to the cathode (-) and titanium abutments will be connected to the anode (+) end of the DC Power Supply. After then abutments will be left in distilled water for 10 minutes and sterilized before insertion in patient mouth.
15817545|NCT04305080|Other|Untreated abutment|Abutment will be left untreated with its gray color.
15817546|NCT04305067|Other|Exercise|Exercise programs will be individually tailored to the capabilities of each participant and gradually progressed accordingly. Each patient will be asked to complete one home-based aerobic exercise sessions each week. At baseline, 16 weeks and 3 month followup patients will complete a physical fitness assessment (30 second sit to stand and six minute walking tests) and a range of quality of life questionnaires. Upon completion of the 16 week exercise intervention, patients will be invited to partake in semi-structured interviews to determine the effectiveness of the program and their experience throughout.
15817555|NCT04305028|Drug|Rivaroxaban|Rivaroxaban 2.5 MG (Xarelto) twice daily, tablet
15817556|NCT04305028|Drug|Aspirin|Aspirin 75-100 mg once daily, tablet
15817557|NCT04305015|Device|NOL Guided Analgesia|NOL values exceeding 25 will typically be treated with boluses of fentanyl 50 µg at roughly 5-minute intervals. The target will be maintained until surgery ends
15817558|NCT04305015|Other|Routine opioid management|Clinical judgement will be according to their standard practice and may include interpretation of blood pressure, heart rate, diaphoresis, tearing, and pupil size. Boluses of fentanyl 50 µg can be given per clinical judgement
15817559|NCT04305002|Drug|Exenatide|Injections, 2 mg once weekly for 18 months
15817560|NCT04305002|Drug|Placebo|Injections, once weekly for 18 months
15817561|NCT04304989|Other|mHealth program|mobile health applications
15817562|NCT04304989|Other|usual care|usual care
15817563|NCT04304976|Device|ROBERT®|Robotic Rehabilitation intervention ROBERT®, designed for early, and supplementary therapy of patients.
15817564|NCT04304963|Other|NO intervention - observational study|NO intervention - observational study
15817565|NCT04304950|Drug|Evening Group|Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 pm and 11:00 pm.
15817566|NCT04304950|Drug|Morning Group|Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 am and 11:00 am.
15817567|NCT04304937|Other|patient reported outcome measure|2 questionnaires are tested against each other
15817568|NCT04304924|Other|The personalized telephone based intervention|"The personalized telephone based intervention:
~Provide Behavioral support to facilitate lifestyle change by a weight loss coach located at a centralized call center. Participants will be paired with an individual coach who will work with the participant through all phases of the 1-year weight loss program. The behavior change program will be based on Social Cognitive Theory, which hypothesizes that the interactions between environmental, personal and behavioral elements determine behavioral change (Bandura 1989);
~Utilize a toolbox approach that will allow for tailoring the intervention to the individual participant. Examples of possible Toolbox solutions include: alternative dietary approaches, instructions for strength-training exercises."
15817569|NCT04304911|Behavioral|Blended intervention (UP-APP)|Unified Protocol (UP) for transdiagnostic treatment of EDs in the blended intervention (UP-APP)
15817570|NCT04304911|Behavioral|Cognitive Behavioral Therapy (TAU)|TAU group that carries out Cognitive Behavioral Therapy in an individual format
15817571|NCT04304898|Other|Home spirometry|"Patients will perform daily home spirometry for three months with a Bluetooth-enabled validated, CE-marked home spirometer (Spiro bank Smart, MIR, Italy). Subsequently, patients will perform weekly home spirometry for two years in total. During this period, patients will be asked to perform three measurements each week on the same day.
~Hospital-based spirometry will be performed according to international guidelines.
~Patients will complete patient-reported outcomes (PROMs) online in the secured application every six months."
15817572|NCT04304885|Diagnostic Test|Sonication method|Sonication dislodges adherent bacteria from explanted prosthetics by ultrasound and may improve the diagnosis of periprosthetic joint infection.
15817573|NCT04304872|Behavioral|Gamification|"Participants sign a pledge agreeing to try their best to meet their goals.
~Participants are entered into a game. Each week they receive 70 points. Each day they're told their step count and points. If the step goal was met they keep their points, but if not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level, but if not, they drop a level. Participants start in the middle of 5 levels.
~Participants choose a support partner who gets a weekly email with the participant's progress. We hold a 3-way phone call with the participant and supportive sponsor to discuss ways they can help the participant meet their goal. At 6 weeks, we have a follow up call if the participant is stuck in a lower level and restart them back at the middle level."
15817574|NCT04304872|Behavioral|Loss-Framed Financial Incentives|Participants are informed that each week $14 is placed in a virtual account for them. Each day the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that $2 was taken away.
15817575|NCT04304859|Diagnostic Test|BASIC|Validation
15817576|NCT04304846|Other|Questionnaires and interviews|List of questionnaires: ASQ, PSI, PPQ, SDQ, GSA and AMMI score obtained from mother during two separated interviews for the mother and the child at 3 and 5 years old
15817577|NCT04304833|Other|Provider-Based Care Model Arm|The PI will be supplementing standard care by providing and training each patient in the use of an analog (not internet connected) vital sign kit for 6 months: weight scale, blood pressure cuff, pulse oximeter. A Log for recording their vital sign measures.
15817578|NCT04304833|Behavioral|mHealth Model Arm|The PI will provide each patient with weight scale, blood pressure cuff, & pulse oximeter kit connected to a Bluetooth-paired Android Health Tablet for 6 months. Daily vital sign readings will be sent to the secure cloud-based software. If the readings are out-of-range, the Registered Nurse Call Center will be automatically alerted and triaged.
15817582|NCT04304807|Drug|Melatonin 20 mg|Melatonin was given as a total dose of 20 mg via enteral route in two doses of 10 mg each with a 1 hour interval in between.
15817583|NCT04304807|Drug|Traditional antibiotic treatment|Traditional antibiotic treatment was given to both groups with feeding intolerance according to treatment protocols by neonatal intensive care units of Ain Shams University
15817584|NCT04304794|Procedure|Administration of iodinated contrast media|Each patient was exposed on iodinated contrast medium administered during computed tomography, coronary angiography or transcatheter aortic valve implantation.
15817585|NCT04304794|Drug|Prophylactic administration of antithyroid drugs before iodinated contrast media exposure|13 patients received thiamazole with (6 patients) or without (7 patients) sodium perchlorate, one day prior to iodinated contrast medium (ICM) and for at least 14 days after for thiamazole (20-40 mg/daily) and 10 days after for sodium perchlorate (900 mg/daily).
15817586|NCT04304781|Drug|KSP/QRH dimer|Peptide 919288G, Lot No. 17081402, Molecular Weight 3577.0, ≥95% purity. Stored at <20°C. Dark green, lyophilized powder in single-use amber vials.
15817587|NCT04304768|Biological|Fluzone Quadrivalent|0.5 ml prefilled syringe administrated intramuscularly
15817588|NCT04304755|Drug|Zoledronic Acid 5 MG in 5 ML Injection|Zoledronic acid
15817589|NCT04304755|Drug|Placebos|NaCl 0.9%
15817590|NCT04304742|Procedure|hip standard radiography/ CT scan/ MRI|hip standard radiography/ CT scan/ MRI
15817591|NCT04304716|Drug|Regional Anesthesia|Block performed is an indwelling wound bed or popliteal catheter placed intraoperatively
15817592|NCT04304703|Device|WHOOP strap 3.0|WHOOP strap 3.0, a photodiode-based device that tracks sleep, resting heart rate, and heart rate variability.
15817593|NCT04304690|Other|blood sample|2 blood samples at T0 and 3 months
15817594|NCT04304677|Device|Percutaneous coronary intervention|"Pre-PCI FFR pullback recording was done with conventional system
~Automated algorithm to calculate delta FFR per unit time was developed
~PCI was performed using 2nd generation DES"
15817595|NCT04304664|Other|Mindfulness- Based Intervention|"Mindfulness- Based Intervention in a psychological intervention, based on mind- body connection.
~The protocol includes a 10- weeks program, with weekly group sessions of 2 hours and one all-day session after seven weeks. The intervention have standardized core elements consisting of different mental and physical mindfulness exercises: 1) body-scan exercises (paying close attention to all body parts, from the feet to the head), 2) mental exercises focusing one's attention on breathing, 3) physical exercises with focus on being aware of bodily sensations and one's own limits during the exercises, and 4) practicing being fully aware during everyday activities by using the breath as an anchor for attention. Essential to all parts of the program is developing an accepting and non-reactive attitude to what one experiences in each moment."
15817596|NCT04304651|Diagnostic Test|Limited cancer screening|"The limited cancer screening will include: 1) a complete medical history and physical examination; 2) complete blood count; 3) liver function tests (AST, ALT, ALP, bilirubin); and 4) chest X-ray.
~In women, a breast examination, Pap smear/pelvic examination (if < 70 years old and previously sexually active) and mammogram will be performed, if not conducted in last year.
~In men, similarly, prostate examination and PSA testing will be performed, if not conducted in the last year.
~All patients will undergo colon cancer screening as per local practice."
15817597|NCT04304651|Diagnostic Test|Limited cancer screening + FDG PET/CT|The limited cancer screening (as described above) in combination with a FDG PET/CT.
15817598|NCT04304638|Radiation|radiation or chemo-radiation|standard treatment for stage III lung cancer
15817599|NCT04304638|Drug|EGFR-TKI Inhibitor|the standard treatment for stage IV lung cancer with EGFR mutation
15817600|NCT04304625|Drug|Tranexamic Acid / Sodium chloride|After the routine prophylactic IV or IM injection of the uterotonic used in the hospital protocol's -either oxytocin or carbetocin - (as recommended by the 2014 guidelines for prevention and management of postpartum hemorrhage from the CNGOF), the intervention will be the IV administration of a 10-ml blinded ampoule of the study drug (either TXA or placebo according to the randomisation sequence) to the patient within 3 minutes after birth, slowly (over 30-60 seconds), once the cord has been clamped
15817601|NCT04304599|Device|LoFric Elle|The study device is commercially available (CE-marked). It is a device for female intermittent catheterization. Treatment Period will last for 2 weeks. The angulated handle available with the device must be used by each subject at least 10 times.
15817602|NCT04304573|Diagnostic Test|Total serum calcium blood test|Total serum calcium measurements will be done on the first postoperative day. Also ionized calcium, corrected total serum calcium for serum albumin with Payne's formula and PTH will be monitored.
15817603|NCT04304560|Drug|Dapagliflozin 10 MG|inhibitor of sodium-glucose cotransporter 2
15817604|NCT04304560|Drug|Placebo oral tablet|Similar Placebo oral tablet
15817605|NCT04304547|Drug|CKD-828, D097, D337, CKD-348 T1, CKD-348 T2|"Subject of sequence A takes IP in the following order:
~Each tablet of CKD-828 and D097 and D337 be taken at once
~CKD-348 T1 1 tablet
~CKD-348 T2 1 tabet"
15817606|NCT04304547|Drug|CKD-348 T1, CKD-348 T2, CKD-828, D097, D337,|"Subject of sequence B takes IP in the following order:
~CKD-348 T1 1 tablet
~CKD-348 T2 1 tablet
~Each tablet of CKD-828 and D097 and D337 be taken at once"
15817607|NCT04304547|Drug|CKD-348 T2, CKD-348 T1, CKD-828, D097, D337|"Subject of sequence C takes IP in the following order:
~CKD-348 T2 1 tablet
~Each tablet of CKD-828 and D097 and D337 be taken at once
~CKD-348 T1 1 tablet"
15817610|NCT04304521|Procedure|Lung recruitment maneuver|Lung recruitment maneuver is used to reopen or prevent collapsed lung under mechanical ventilation so as to decrease respiratory complications. LRM induces a transient increase in intra-thoracic pressure and decreases in venous return, leading to a decrease in left ventricular end-diastolic area and stroke volume.
15817611|NCT04304508|Drug|BAY2433334|Tablet, taken orally once a day.
15817612|NCT04304508|Other|BAY2433334 matching placebo|Tablet, taken orally once a day.
15817747|NCT04303429|Drug|FOLFOX/XELOX/Capecitabine|Patients enrolled in the chemotherapy group will receive postoperative chemotherapy (investigator's choice) for 3 months or 6 months.
15817613|NCT04304495|Other|Fall Prevention|The intervention arm participants will receive a physical therapy and pharmacy consults as well as Apple Watch training and an Apple Watch device to test memory and mobility during the ED visit and during our home visits.
15817614|NCT04304482|Drug|ANAVEX2-73 oral liquid|Liquid oral solution
15817615|NCT04304482|Drug|Placebo oral liquid|Liquid oral solution
15817616|NCT04304469|Other|surveys|delivery of the survey at a domestic violence consultation
15817617|NCT04304469|Other|follow-up|follow-up of women 6 months after their consultation
15817618|NCT04304456|Other|Treatment|Antimicrobial and other treatment modalities such as source control, vasoactive medications, dialysis
15817619|NCT04304430|Drug|Dapagliflozin|Initiation of dapagliflozin according to clinical indication
15817620|NCT04304430|Drug|DPP-4 inhibitor|Initiation of DPP-4i according to clinical indication
15817621|NCT04304404|Behavioral|Breast Cancer Risk Reduction Program (BrCaRRP)|Women in the intervention group will complete the pre-tests electronically, and a 12-week intervention program will be implemented. The first meeting will be face-to-face individual training. In this training session, the risk of developing breast cancer will be calculated with each participant using breast cancer risk assessment tools. Modifiable and non-modifiable factors that increase breast cancer risk will be explained. With the participant, it will be decided which of the modifiable risk factors will be improved. Guidance will be given on topics such as genetic counseling, breast cancer screenings, increasing physical activity, healthy nutrition, weight control, smoking and alcohol use. The interventions will continue with phone calls and the 12-week program will be completed.
15817622|NCT04304391|Procedure|Resective Gingival Surgery|Gingivectomy and gingivoplasty:Resective gingival surgical procedured
15817623|NCT04304378|Behavioral|Stabilization Techniques (ST)|The Stabilization Techniques intervention provides an opportunity to improve emotion/affect regulation and coping skills. The overarching goal of these sessions is to introduce different ways of managing emotional distress through imagery and stress reduction techniques. ST sessions focus on providing coping mechanisms for managing important symptoms of PTSD (i.e., hyperarousal, negative emotions, and physical symptoms).
15817624|NCT04304378|Behavioral|Stabilization Techniques with Behavioral Activation (ST+BA)|The Stabilization Techniques with Behavioral Activation intervention includes stabilization techniques as well as sessions targeted at increasing time engaged in physical activities during times outside of the intervention session. Preferred activities are selected by the participant. Strategies to foster engagement in the selected activities will include self-monitoring, structuring and scheduling daily activities, rating the degree of pleasure and accomplishment experienced during engagement in specific daily activities, exploring alternative behaviors related to achieving goals, and using role-play to address specific barriers. Establishing/maintaining routines and behavioral strategies to reduce avoidance and mange negative emotions are emphasized.
15817625|NCT04304378|Behavioral|Eye Movement Desensitization and Reprocessing (EMDR)|EMDR is an exposure-based treatment that is the standard of care for PTSD delivered by the Mekong Project in Phnom Penh. EMDR utilizes sensory stimulation when participants are engaged in mental processing of traumatic material. EMDR follows a sequential framework targeting 1) past memories, 2) present symptoms, and 3) future actions.
15817626|NCT04304365|Other|Follow-up clinic visit|Participants will be scheduled for a visit with a provider in 1-2 weeks that will include an ultrasound examination.
15817627|NCT04304365|Other|Text message|Participants will be instructed that they will be contacted by research staff through text message 14 days after the initial visit. They will receive a survey link through text message at this time.
15817628|NCT04304365|Other|Low Sensitivity Pregnancy Test (LSPT)|Participants will be instructed on how to test their urine 14 days after the medication abortion for continued pregnancy. LSPT can detect hCG levels as low as 2000 mIU/ml.
15817629|NCT04304352|Drug|Vinorelbine|Metronomic Vinorelbine 40 mg orally thrice a week
15817630|NCT04304352|Drug|Capecitabine|Metronomic Capecitabine 500 mg, thrice daily
15817631|NCT04304352|Drug|Cyclophosphamide|Metronomic Cyclophosphamide 50 mg daily
15817632|NCT04304339|Other|Hypercapnic respiratory failure|Patients with hypercapnic respiratory failure will be followed without any additional intervention
15817633|NCT04304326|Other|Resistence Exercise|"Underwent resistance exercise twice a week, for twelve weeks for the following muscles group: upper limbs, lower limbs and trunk.
~It was carried out two exercises for major muscle groups and one exercise for small muscles. The exercises were divided in 3 sets of 12 repetitions for each muscle group. The intensity of the exercises was 60% of one-maximum repetition (1RM).
~The exercise program involved pectoral exercises: crucifix and seat supine; biceps: alternated screw; triceps: triceps pulley; back: standing handsaw and pulled ahead; quadriceps: leg extensor and finally gluteus: standing hips extension."
15817634|NCT04304313|Drug|Sildenafil citrate tablets|0.1g/day for 14 days
15817635|NCT04304287|Procedure|Preoperative autologous blood donation, 14 days before surgery|
15817636|NCT04304287|Procedure|Preoperative autologous blood donation, 72 hours before surgery|
15817637|NCT04304287|Procedure|Without preoperative blood donation|
15817638|NCT04304274|Procedure|Paravertebral block-ropivacaine|Inject 25 ml 0.5% ropivacaine in the T8 paravertebral space followed with catheter insertion and continuous 0.2% ropivacaine infusion(infusion rate: 0.125ml/kg/pulse,1pulse/h)
15817639|NCT04304274|Procedure|Paravertebral block-saline|Inject 25 ml 0.9% saline in the T8 paravertebral space followed with catheter insertion and continuous 0.9% saline infusion(infusion rate: 0.125ml/kg/pulse,1pulse/h)
15817640|NCT04304274|Drug|patient controlled analgesia with morphine|Morphine was given as intravenous patient-controlled analgesia bolus: 1-2mg, lock time: 5min, 1h limitation: 8mg
15817641|NCT04304261|Drug|Dapagliflozin|Near infrared detection of brain function in diabetic patient at baseline and after 12 weeks of Dapagliflozin(10mg/day) treatment
15817642|NCT04304261|Drug|Metformin|Near infrared detection of brain function in diabetic patient at baseline and after 12 weeks of Metformin (1500-2000mg/day) treatment
15817643|NCT04304248|Drug|Albumin-bound paclitaxel, Carboplatin, Toripalimab|Eligible patients will receive Toripalimab 240mg + Albumin-bound paclitaxel 260mg/m2 + Carboplatin AUC5 for 3 cycles every 21 days (+/-3 days) as neoadjuvant treatment
15817748|NCT04303416|Drug|Albumin solution|plasma exchange with albumin, one per week for one month, then one per month for 5 months
15817749|NCT04303403|Drug|Trametinib|Taken orally once daily
15817644|NCT04304235|Device|Pediatric Rapid Sepsis Trigger (PRST) tool|The digital platform consists of a mobile application integrating a pulse oximetry sensor attached to this device, with embedded smart algorithms that predict a critically ill state, or level of risk (below) in a child presenting at the hospital. The platform also includes an interactive dashboard located in strategic locations (e.g., laboratory, consultation rooms), which connects to the mobile application through a secure local network and displays the triage data to provide real-time monitoring for the physicians who manage the patients.
15817645|NCT04304235|Other|Emergency Triage and Treatment (ETAT) guidelines|These are the triage guidelines currently applied in the study hospital sites. This will be the comparator group.
15817646|NCT04304222|Device|3D Printed Denture Framework|The Denture Framework is 3D printed from the digital image obtained from the denture mold.
15817647|NCT04304209|Drug|Oxaliplatin|130mg/m2, d1 q3w, in Capeox regimen (100mg/m2 when used cocurrently with radiotherapy), intravenous infusion
15817648|NCT04304209|Drug|Capecitabine|1000mg/m2, bid, qd1-14, q3w, in Capeox regimen, oral administration
15817649|NCT04304209|Drug|Sintilimab|200mg, d1 q3w, intravenous infusion
15817650|NCT04304209|Radiation|radiotherapy|neoadjuvant radiotherapy with 50Gy to GTV, 45Gy to CTV in 25 fractions.
15817651|NCT04304209|Procedure|total mesorectal excision|total mesorectal excision after neoadjuvant treatment
15817652|NCT04304209|Other|Watch and wait|Watch and wait for cCR patients after neoadjuvant treatment
15817653|NCT04304196|Other|TEMPO|TEMPO is designed as a 7- to 10-week, web-based intervention containing 5 modules to pace patient-caregiver dyads' learning, avoid information overload, and allow sufficient practice time in-between modules . Each module is organized along six key components: needs assessment, tailored information and skills training, goal setting and action planning, motivational and social support, monitoring, automated feedback, and addressing time demands. Overall, modules aim to a) increase dyads' confidence in using strategies to address key psychosocial issues in the acute survivorship phase (e.g., dealing with stress and worry, communicating with partner and family, uncertainty management) and b) assist dyads in developing the self-regulatory skills necessary to meet the physical activity guidelines. Each module specifies a series of online (i.e. didactic material and interactive worksheets) and offline activities (i.e. practicing the proposed skills).
15817654|NCT04304196|Other|Usual care|Patients will receive usual care throughout the study. Dyads in this group will not receive any information resources from the research team, but will have access to all of those available at their participating center (sites will be asked to provide a description of usual care practices). Participants will be given access to the TEMPO website after having completed their final questionnaire, as thanks for participating.
15817655|NCT04304183|Procedure|total colectomy, ileorectal anastomosis|all patients underwent total colectomy and ileorectal anastomosis.The anastomosis was stapled in all patients.
15817656|NCT04304170|Dietary Supplement|VES002|The sachets were to be dissolved in 200 ml of water at room temperature to be taken before breakfast.
15817657|NCT04304170|Other|Placebo|The sachets were to be dissolved in 200 ml of water at room temperature to be taken before breakfast.
15817658|NCT04304157|Drug|Dexmedetomidine|Dexmedetomidine (DEX) a potent α 2 agonist that have unique analgesic, anxiolytic and sedative profile has been called upon as attractive adjunct in general as well as regional anesthesia with enticing results. Several studies have pursued DEX median effective dose (ED50) in different settings e.g., co induction agent with Propofol, in laryngeal muscle insertion and with local anesthetic to enhance the quality of spinal anesthesia
15817659|NCT04304144|Drug|CAEL-101|The investigational product, CAEL-101, is formulated as a sterile liquid solution of protein plus excipients for dilution in a single-use, stoppered, glass vial. Each 10 mL vial contains 300 mg of CAEL-101 at a concentration of 30 mg/mL. CAEL-101 will be diluted with commercially available 0.9% Normal Saline.
15817660|NCT04304144|Drug|cyclophosphamide, bortezomib, and Dexamethasone (CyBorD)|According to institutional standard of care.
15817661|NCT04304144|Drug|Daratumumab|An investigative treatment for AL amyloidosis
15817662|NCT04304131|Diagnostic Test|Earlytect Colon Cancer|A diagnostic device measuring syndecan 2 methylation status in stool DNA to detect colorectal cancer
15817663|NCT04304092|Other|Exercise|Participants will exercise under supervision. Exercise dose will vary by amount and intensity
15817664|NCT04304079|Device|ARssist system|As stated in ARssist system arm description
15817665|NCT04304066|Other|18F-WL12 PET or 68Ga-WL12 PET|WL12, labeled with PET radio-nuclide ( Ga-68 or F-18)will be used as a molecular imaging tracer for PET/CT scanning
15817666|NCT04304053|Drug|Treatment and prophylaxis|"Cases will be offered a therapeutic regimen hydroxychloroquine (200mg tablets) 800mg on day 1, and 400mg on days 2-7
~Contacts will be offered a prophylactic regimen of hydroxychloroquine (200mg tablets) 800mg on day 1, and 400mg on days 2-7."
15817667|NCT04304053|Other|Standard Public Health measures|Isolation of patient and contact tracing as per national guidelines.
15817668|NCT04304040|Drug|Orelabrutinib|BTK inhibitor Orelabrutinib low dose or high dose; Part A:28days/cycle, Cycle1:35days; Part B:21 days/cycle, Cycle1:28days.
15817669|NCT04304040|Drug|Recombinant humanized monoclonal antibody MIL62 injection|Recombinant humanized monoclonal antibody MIL62 injection, 800mg or1000mg each time, Part A:28days/cycle, Cycle1:35days; Part B:21 days/cycle, Cycle1:28days.
15817670|NCT04304027|Other|Tailored exercise intervention|2x 30 minute aerobic interval training per week for 8 weeks - sessions involve 6 intervals cycling for 2 minutes at target heart rate reserve followed by 2 minutes working rest (target heart rate reserve may vary between sessions depending on the level of self-reported fatigue)
15817671|NCT04304027|Other|Standard exercise intervention|2x 30 minute aerobic interval training per week for 8 weeks - sessions involve 6 intervals cycling for 2 minutes at >70% heart rate reserve followed by 2 minutes working rest
15817672|NCT04304014|Dietary Supplement|L. reuteri|(10^8 CFU) once a day
15817673|NCT04304014|Dietary Supplement|B. longum and P. Pentosaceus|(10^9 CFU) once a day
15817750|NCT04303403|Drug|Ruxolitinib|Taken orally twice daily
15817751|NCT04303390|Drug|Cefuroxime|second generation cephalosporin
15817752|NCT04303390|Drug|Cefazolin Injection|First generation cephalosporin
15817753|NCT04303390|Other|24 hours|Duration of antibiotic therapy
15817754|NCT04303390|Other|48 hours|Duration of antibiotic therapy
15817912|NCT04302064|Drug|Placebo|AKCEA-TTR-LRx-matching placebo administered SC
15817674|NCT04304001|Behavioral|Community Health Advisor|"Intervention arm participants will receive one 45-minute face-to-face meeting followed by two CHA phone calls in one-week intervals over a period of three weeks beginning within one month following baseline survey completion. These CRC educational activities delivered by the CHAs will include the use of NCI CRC resources and materials, including an S2S PowerPoint presentation, and CRC educational brochures. The intervention will follow a conversation guide/standard script for intervention fidelity. CHAs will take notes following each interaction to document the call length, deviations from the script, and tone of the call. Participants will receive an additional text message reminder once a week for an additional three weeks - with instructions for participants to text yes to confirm they received the message - for a total of six weeks of intervention delivery. The personalized text messages will have positive tones and include short messages about the benefits of CRC screening."
15817675|NCT04304001|Behavioral|Usual care|Control arm participants will receive a FIT kit, a mailed targeted colorectal cancer brochure, and complete a follow-up telephone survey at 3- and 12-months after the mailing.
15817676|NCT04303988|Drug|Pyrotinib|PO
15817677|NCT04303988|Drug|Temozolomide Injection|IV
15817678|NCT04303988|Drug|SHR-1316|IV
15817679|NCT04303988|Drug|Bevacizumab|IV
15817680|NCT04303988|Drug|Cisplatin/Carboplatin|IV
15817681|NCT04303975|Other|clinical measurements|Only clinical parameters were recorded, no intervention was made.
15817682|NCT04303949|Other|Behavioral:|Facilitating couples reduce anxiety, depression and grief through e-book education.
15817683|NCT04303936|Device|SenseWear® armband device|"Metabolic Holter, Physical Activity and Lifestyle, Portable outpatient multi-sensor energy consumption in calories (EE), movement, physical activity, quality of life, sleep"
15817684|NCT04303923|Procedure|Ultrasonography|The diameters of both the radial artery and the distal radial artery were measured by ultrasonography.
15817685|NCT04303897|Device|XEN Glaucoma Stent|Data are collected from patients who are implanted with XEN via the specific urgent medical needs for named patient use regulatory pathway in Hainan
15817686|NCT04303884|Drug|Pembrolizumab Injection [Keytruda]|Pembrolizumab administration at a fix dose of 200 mg every 3 weeks
15817687|NCT04303871|Diagnostic Test|Invasive blood pressure assessment by radial artery canulation|radial artery canula used to measure central blood pressure compared to non invasive automated device to measure BP in pregnant females
15817688|NCT04303858|Drug|RO7284755|Participants will be administered RO7284755 weekly.
15817689|NCT04303858|Drug|Atezolizumab|Participants will be administered 1200 mg of atezolizumab once every 3 weeks.
15817690|NCT04303845|Drug|Erenumab|140 mg of erenumab via subcutaneous injection
15817691|NCT04303832|Other|eye exercises|Eye exercises for correcting eye deviation
15817692|NCT04303832|Device|eye glasses|Eye glasses for correcting eye deviation
15817693|NCT04303819|Drug|Exenatide treatment|12 weeks of exenatide injection, 5 μg twice a day by subcutaneous injection for 4 weeks, followed by 10 μg twice a day for 8 weeks, as recommended by the drug manufacturer.
15817694|NCT04303806|Drug|rosuvastatin|receive rosuvastatin orally once daily.
15817695|NCT04303793|Device|Percutaneous PDA closure|transcatheter patent ductus arteriosus closure
15817696|NCT04303780|Drug|AMG 510|21 day cycles
15817697|NCT04303780|Drug|Docetaxel|21 day cycles
15817698|NCT04303767|Drug|Casein phosphopeptide amorphous calcium phosphate|varnish containing calcium and phospate ions which act as a source for tooth remineralization
15817699|NCT04303767|Procedure|Atraumatic restorative treatment|excavation of dental caries and restoring with light cured Glass Ionomer Restoration
15817700|NCT04303754|Other|Diabetes-Specific Formula|Other: Diabetes Specific Formula
15817701|NCT04303754|Other|Bread with Spread|Other: White Bread with Spread
15817702|NCT04303754|Other|Rice Porridge|Other: Rice Porridge
15817703|NCT04303741|Drug|Camrelizumab|Camrelizumab 200mg (3mg/kg for patient whose weight is below 50kg) will be administered as an intravenous infusion over 30 minutes every three weeks until unacceptable toxic effects or disease progression or other termination criteria appeared. Patients received up to two years of treatment.
15817704|NCT04303741|Drug|Apatinib|Apatinib 250mg will be administered daily until unacceptable toxic effects or disease progression or other termination criteria appeared. Patients received up to two years of treatment.
15817705|NCT04303741|Drug|Eribulin|Eribulin Mesylate will be administered as a 1.4 mg/m2 intravenous (IV) injection over 2 to 5 minutes on day 1 and day 8 of each 21-day cycle until unacceptable toxic effects or disease progression or other termination criteria appeared. Patients received up to two years of treatment.
15817706|NCT04303728|Diagnostic Test|Muscle ultrasound|The muscle thickness and muscle quality will be assessed on ultrasound
15817707|NCT04303715|Procedure|No SLNB|BCS only. Ommission of SLNB by axilla ultrasonography among selective breast cancer patients
15817708|NCT04303715|Procedure|SLNB|BCS with SLNB(+/-ALND)
15817709|NCT04303702|Drug|Oxytocin|The administration and titration of oxytocin for labor augmentation is per a hospital based protocol. To summarize, oxytocin is initiated intravenously at 2 milliunits/minute and increased by 2 milliunits/minute every 20 minutes until an adequate contraction pattern is attained or a maximum of 40 millunits/minute has been achieved. This protocol for titration and administration will be applied in this study to the oxytocin group. The intravenous pumps on Labor and Delivery have automated functions for intravenous administration of oxytocin that is milliunit-based and the same routine pumps will be used in this study. The study bag will be administered per current oxytocin protocol. Since patients will already be on oxytocin at time of randomization, their current bag of oxytocin will be replaced by a masked study bag of either placebo or oxytocin until delivery.
15817710|NCT04303702|Drug|Placebo|Patients receiving placebo will receive intravenous 0.9% sodium chloride from a masked bag. The rate of administration will be the same as the rate that would have otherwise been administered by the institutional oxytocin protocol.
15817755|NCT04303377|Biological|Evolocumab|Evolocumab 140 mg every 2 weeks plus Standard of Care, including optimal lipid lowering treatment (high dose of statin ± ezetimibe)
15817713|NCT04303676|Other|Virtual Practice Facilitation with e-Learning|"Virtual practice facilitation intervention using e-learning modules to guide the sessions includes:
~a. Practice Facilitator (PF) conducts 7 monthly virtual visits with each practice QI team i. Optional: PFs and practices may choose to conduct virtual facilitation in groups of up to 5 practices simultaneously b. MAT training (combination of virtual academic detailing plus online training resource) plus ongoing support to deal with questions through email and/or office hours with our project staff, experts, with additional consultation if needed with an addiction medicine specialist.
~c. Resources largely included as part of the e-learning module, but supplemented by online resource hub d. Centralized remote health information technology assistance, focused on implementation of registry functionality to track patients for population management and to report the measures required by AHRQ."
15817714|NCT04303676|Other|Virtual Practice Facilitation without e-Learning|"Virtual practice facilitation intervention without e-learning to guide the sessions includes:
~a. Practice Facilitator (PF) conducts 7 monthly virtual visits with each practice QI team i. Optional: PFs and practices may choose to conduct virtual facilitation in groups of up to 5 practices simultaneously b. MAT training (virtual academic detailing) plus ongoing support to deal with questions through email and/or office hours with our project staff, experts, with additional consultation if needed with an addiction medicine specialist c. Online resource hub d. Centralized remote health information technology assistance, focused on implementation of registry functionality to track patients for population management and to report the measures required by AHRQ."
15817715|NCT04303663|Procedure|Fibular Plate|ORIF with Plating
15817716|NCT04303663|Procedure|Fibular Nail|CRIF +/- ORIF with Fibular nail
15817717|NCT04303650|Device|Ultrasound measurement of quadriceps muscle layer thickness|With patient in supine position ultrasound will be performed using a 12MHZ Transducer connected to Sonosite M Turbo machine. The probe will be placed perpendicular to the long axis of the thigh on its anterior surface at the two thirds of the length between the anterior superior iliac spine and the upper border of the patella. After identifying the muscle tissue, the thickness of the quadriceps muscle will be obtained by measuring the distance between the cortex of femur and the most superficial muscular fascia. Measurements will be performed by applying maximal compression on the probe without inflicting pain to prevent underestimation of muscle wasting linked to subcutaneous edema. measurements will be made on both sides repeatedly on ICU days 1, 3, 7, and 10. Every time three ultrasound measurements will be taken per site and the average of three measurements for each site will be used and combined to provide total muscle depth
15817718|NCT04303637|Behavioral|Phone use|Objective and subjective reports of smartphone use (e.g., number of hours, number of pick-ups, how phones are used)
15817719|NCT04303624|Other|Health sciences survey|Large scale demographic survey evaluating attitudes of population towards organ donation for the self vs. family
15817720|NCT04303598|Drug|FNC|3mg, 1 tablet，QD
15817721|NCT04303598|Drug|3TC|300mg, 1 tablet，QD
15817722|NCT04303598|Drug|TDF|300mg, 1 tablet，QD
15817723|NCT04303598|Drug|EFV|200mg, 1 tablet，QD
15817724|NCT04303598|Drug|FNC placebo|1 tablet，QD
15817725|NCT04303598|Drug|3TC placebo|1 tablet，QD
15817726|NCT04303585|Procedure|SAP block|The anesthesiologist performs SAP block immediately before surgery under ultrasound guide
15817727|NCT04303585|Procedure|ESP block|The anesthesiologist performs ESP block immediately before surgery under ultrasound guide
15817728|NCT04303572|Drug|Eloctate ITI|This is a factor VIII-Fc infusion protein.
15817729|NCT04303572|Drug|Emicizumab|This is a bispecific monoclonal antibody FVIII mimic.
15817730|NCT04303559|Drug|Eloctate Injectable Product|This is a factor VIII-Fc fusion protein.
15817731|NCT04303559|Drug|Emicizumab Injection [Hemlibra]|This is a bispecific monoclonal antibody FVIII mimic.
15817732|NCT04303546|Device|arterial stiffness measurements|We will measure arterial stiffness by VOPITB and with others devices to validate VOPITB
15817733|NCT04303533|Device|Neuro-Feedback EFP|Neurofeedback (NF) - is a treatment method based on learned self-modulation of neural activity in response to feedback of neural signal. Amygdala-EFP (EEG-finger-print, EFP) is an EEG-NF application that modulates amygdala response.
15817734|NCT04303520|Biological|anti-CD19/CD22 CAR-T cells|Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-CD22 CARs
15817735|NCT04303520|Drug|Fludarabine|30mg/m2/d
15817736|NCT04303520|Drug|Cyclophosphamide|500mg/m2/d
15817737|NCT04303507|Drug|Chloroquine or Hydroxychloroquine|A loading dose of 10 mg base/ kg followed by 155 mg daily (250mg chloroquine phosphate salt or 200mg of or hydroxychloroquine sulphate) will be taken for 3 months
15817738|NCT04303507|Drug|Placebo|Placebo
15817739|NCT04303494|Biological|immunisation|combined diphtheria, tetanus, acellular pertussis, poliomyelitis, hepatitis B, ± Haemophilus influenzae type B and simultaneous pneumococcus (PCV13) vaccination
15817740|NCT04303481|Other|normal diet|Control
15817741|NCT04303481|Other|weight loss program kit|Subjects should adhere to the eating plan, which contained the following kit components : four flavors of collagen drinks [i.e., Caviar Collagen Enzyme Drink, Collagen Enzyme Drinks (Peach Taste), Collagen Enzyme Drinks (Grape Fruit Taste), Saussurea involucrata Enzyme Drink (Litchi Taste)], six flavors of mike shakes (i.e., Corn Soup Mike Shake, Strawberry Mike Shake, Chocolate Mike Shake, Vanilla Mike Shake, Banana Mike Shakes, Matcha Mike Shakes), Fruit and Vegitable Congee, and Botanical Liquid Sachet.
15817742|NCT04303481|Other|weight loss program kit with A. muciniphila prebiotics|Subjects should adhere to the eating plan, which contained the following kit components : four flavors of collagen drinks [i.e., Caviar Collagen Enzyme Drink, Collagen Enzyme Drinks (Peach Taste), Collagen Enzyme Drinks (Grape Fruit Taste), Saussurea involucrata Enzyme Drink (Litchi Taste)], six flavors of mike shakes (i.e., Corn Soup Mike Shake, Strawberry Mike Shake, Chocolate Mike Shake, Vanilla Mike Shake, Banana Mike Shakes, Matcha Mike Shakes), Fruit and Vegitable Congee, Botanical Liquid Sachet, and Probiotics Liquid Sachet
15817743|NCT04303468|Dietary Supplement|GABA|The dietary supplement GABA will be taken orally 3 times daily, before each main meal
15817744|NCT04303468|Other|Placebo|Gelatin capsule containing powdered cellulose
15817745|NCT04303455|Diagnostic Test|blood sampling|sampling serum renin
15817746|NCT04303442|Procedure|TEP|Total extraperitoneal laparoendoscopic hernia repair with one or three skin incisions.
15817788|NCT04303039|Drug|ABP-671|ABP-671 Tablet 1.0 mg
15817789|NCT04303026|Drug|Zoledronic Acid|5mg IV infusion
15817756|NCT04303338|Procedure|Masotherapy with neural tension and masotherapy with non-neural tension|To compare the effectiveness of masotherapy with neural tension and masotherapy with non-neural tension
15817757|NCT04303325|Drug|Esketamine|All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to esketamine 0.2mg/kg.
15817758|NCT04303325|Drug|Saline Solution|All depression patients undergoing breast cancer operation will be to the treatment intervention with general anesthesia as an adjunct to saline.
15817759|NCT04303312|Other|Benzydamine Hydrochloride|Patients will rinse by mouth three times daily for 20 days
15817760|NCT04303312|Combination Product|Solcoseryl and pumpkin seed oil|Patients will receive by mouth three times daily for 20 days
15817761|NCT04303299|Drug|Oral|Anti virus treatment
15817762|NCT04303260|Behavioral|Physical exercises|The interventional exercise regimen will include specific exercises postulated to increase blood flow to the intestine and colon and thereby promote normal peristaltic s and decrease inflammation.
15817763|NCT04303247|Biological|CD19 and CD22 targeted CAR-T cells|The T cells aphesis from subjects then been manufactured to express CAR to binding CD19 and CD22 on B-cell lymphoma.
15817764|NCT04303234|Other|Artinibsa|local anaesthetic solution with a short latency time. Its high lipid solubility gives it better diffusion through soft tissues and bone and makes it highly effective for infiltrative techniques.Each ml contains 4%Articaine 1:100000.
15817765|NCT04303234|Other|Artpharma|Its a special amide local anesthetic contain 4% articaine with epinephrine 1/200000 as a vasoconstrictor ,Contains only sulfite as a stabilizer (max 0.31 mg)
15817766|NCT04303221|Other|Exercise|The exercises will be performed three times a week (Mondays, Wednesdays and Fridays), lasting 60 min, 10 minutes of warm-up, 40 min of multisensory exercises, and 10 min of final relaxation, for 12 weeks.
15817767|NCT04303208|Procedure|2 ml of whole blood sample will be collected on EDTA tube|2 ml of whole blood sample will be collected on EDTA tube
15817768|NCT04303195|Drug|NG101|Capsules
15817769|NCT04303182|Procedure|Standard 3 port TEP|3 port TEP inguinal hernia repair with 10mm. port under the umbilicus and two 5mm. port in line under the 10mm. port
15817770|NCT04303182|Procedure|LESS TEP|TEP inguinal hernia repair with one vertical skin incision under the umbilicus
15817775|NCT04303143|Behavioral|Self-Hypnosis|Self-Hypnosis
15817776|NCT04303143|Behavioral|Direct Autonomic Experience Control|Direct Autonomic Experience Control. Use of learned mental tool/process to affect outcome measure of SUDS discomfort experience. (eg. Squeeze hand as pre-learned mental anchor to relieve discomfort in lower legs)
15817777|NCT04303130|Drug|Camrelizumab|"Carelizumab: PD-1 antibody SHR-1210: SHR-1210 is administered by intravenous infusion, a fixed dose of 200 mg, and intravenous infusion over 30 minutes (the overall infusion time including the flushing time is not shorter than 20 minutes, not longer than 60 minutes), once every 3 weeks, continued medication until the disease progresses intolerable toxicity and receive immunotherapy for a maximum of 2 years (35 cycles); Endo: once a day, 7.5 mg / m2 intravenous infusion, continuous administration for 14 days, rest for a week (or the corresponding dose using a micro-micropump), continued medication until disease progression toxicity intolerance.
~The combination regimen is a medication cycle every three weeks (21 days)."
15817778|NCT04303117|Drug|NHS-IL12|An initial dose of 16.8 mcg/kg administered subcutaneously every 4 weeks and at an MTD dose with M7824 on day 1 of a 28-day cycle.
15817779|NCT04303117|Drug|NHS-IL12+M7824|1200 mg administered IV every two weeks while on NHS-IL12.
15817780|NCT04303104|Other|GeneXpert Edge|Screening intervention: novel diagnostic for Active Case Finding (GeneXpert MTB/RIF) for TB on sputum collected and performed at point-of-contact in a mobile van
15817781|NCT04303104|Other|GeneXpert Ultra|Screening intervention: novel diagnostic test for Active Case Finding (GeneXpert MTB/RIF) for TB on sputum collected at point-of-contact in a mobile van but sent to laboratory
15817782|NCT04303091|Behavioral|Physical Activity for Advanced Cancer Treatment (PAACT)|12-week physical activity intervention. 60 minute group-based exercise classes held once per week. Home-based exercise recommendations provided weekly along with basic take-home exercise equipment. Optional palliative care consultations offered.
15817783|NCT04303078|Other|Varying levels of harness support during walking|Participants will complete a standard gait and motion analysis at varying levels of harness support (low, moderate, and high levels of support).
15817784|NCT04303065|Drug|Dexamethasone Oral|It will be a short and descending course of oral dexamethasone: 4mg/6 hours (2 days); 4 mg/8 hours (2 days); 2 mg/6 hours (2 days); 2 mg/8 hours (2 days); 1 mg/8 hours (2 days); 1 mg/12 hours (2 days).
15817785|NCT04303065|Drug|Placebo oral tablet|The preparation and conditioning of the placebo capsules will be carried out following the standardized work procedures of the pharmaceutical laboratory and its quality controls, previously authorized by the Agencia Española del Medicamento (AEMPS).
15817786|NCT04303052|Device|Angiodynamic Bioflo Picc IR-KIT (145 cm guidewire) or|Before Power-PICC-line catheter implantation, the patients undergo an examination of the planned intervention site and ultrasound check, and analysis of the blood tests. An informed consent discussion and the patient's signature on the informed consent are obligatory. The length of the catheter and the optimal position of the catheter tip are verified by fluoroscopy. After catheter implantation, the tip location is verified by a final chest x-ray. The follow-up visit and the control of the puncture site until removal of the catheter are performed during hospitalization or subsequently by the treating family doctor.
15817787|NCT04303052|Device|Angiodynamic Bioflo Picc MST-KIT (70 cm guidewire)|Before Power-PICC-line catheter implantation, the patients undergo an examination of the planned intervention site and ultrasound check, and analysis of the blood tests. An informed consent discussion and the patient's signature on the informed consent are obligatory. The length of the catheter and the optimal position of the catheter tip are verified by fluoroscopy. After catheter implantation, the tip location is verified by a final chest x-ray. The follow-up visit and the control of the puncture site until removal of the catheter are performed during hospitalization or subsequently by the treating family doctor.
15817791|NCT04303013|Behavioral|Meditation|Patients will attend weekly in person guided meditation sessions during the course of their radiation treatment. Patient will complete quality of life surveys before, during and after treatment.
15817792|NCT04303013|Other|Standard of Care|Patient not assigned to meditation will undergo radiation with usual care and complete quality of life surveys before, during and after treatment.
15817793|NCT04303000|Drug|Opioid Overdose Education with Naloxone Distribution|Online audiovisual training focused on recognizing the signs of an opioid overdose and administering naloxone. Participants are provided with a naloxone kit.
15817794|NCT04303000|Drug|Opioid Overdose Education|Online audiovisual training focused on recognizing the signs of an opioid overdose and administering naloxone. Participants are provided with information on where they can obtain a naloxone kit.
15817795|NCT04302974|Procedure|Different structures and processes of primary care management strategies|Different structures and processes of primary care management strategies includes: Multi-morbidity, continuity-of-care, different service delivery models and management strategies (i.e. investigation frequency and specific drug regimens)
15817796|NCT04302974|Procedure|Multi-disciplinary Risk Factor Assessment and Management Programmes for diabetes (RAMP-DM)|Under the Multi-disciplinary Risk Factor Assessment and Management Programmes (RAMP) for diabetes (RAMP-DM), multi-disciplinary teams of health care professionals (doctors, nurses, dietitians, pharmacists, opticians etc) were established at designated GOPCs. All DM patients are eligible to enrol into the DM RAMP programmes. Each patient in the RAMP receives a comprehensive risk factor and complication screening to determine his/her overall cardiovascular risk and presence of modifiable risk factors, and according to their risk level and need, the patient may receive additional interventions such as additional counselling by the nurse or additional consultations with a senior doctor.
15817797|NCT04302974|Procedure|Multi-disciplinary Risk Factor Assessment and Management Programmes for hypertension (RAMP-HT)|Under the Multi-disciplinary Risk Factor Assessment and Management Programmes (RAMP) for hypertension (RAMP-HT), multi-disciplinary teams of health care professionals (doctors, nurses, dietitians, pharmacists, opticians etc) were established at designated GOPCs. All HT patients are eligible to enrol into the HT RAMP programmes. Each patient in the RAMP receives a comprehensive risk factor and complication screening to determine his/her overall cardiovascular risk and presence of modifiable risk factors, and according to their risk level and need, the patient may receive additional interventions such as additional counselling by the nurse or additional consultations with a senior doctor.
15817798|NCT04302974|Procedure|Patient Support Call Centre (PSCC)|RAMP Patients can also be referred to the Patient Empowerment Programme(PEP) - a structured self-care education programme delivered by non-governmental organisations(NGOs). If the DM control is suboptimal but the patient is unable to attend the PEP, they may be referred to the Patient Support Call Centre(PSCC) service. PSCC provides individualized telephone counselling by trained nurses. PSCC empowers high-risk DM patients to engage in self-care behaviours by providing regular protocol-led telephone support to advise and reinforce healthy behaviours. Targeted self-care behaviours include self-monitoring, medication management, balanced diet, exercise, risk factor reduction, problem solving and healthy coping. Enrolled patients receive weekly to bi-weekly calls in the first 3 months and additional calls as required for a maximum of 9 months. Subsequent follow-up calls are undertaken to assess self-care behaviours related to the selected goals and to develop a care plan with the patient.
15817801|NCT04302948|Other|HCV RNA screening|The Cepheid Xpert testing requires a fingerstick to obtain blood spots which are then tested for HCV RNA. Results available within one to two hours, facilitating counseling for patients to link to care.
15817802|NCT04302935|Other|Global pain-assessment|Global pain-assessment, based on the ICF framework
15817803|NCT04302909|Other|focused extracorporeal shock wave therapy|40 Patients with mild to moderate CTS will be randomized to receive either fESWT (1-session a week for 3 weeks) or sham fESWT(1-session a week for 3 weeks). All subjects will be asked to wear night splints.
15817804|NCT04302909|Other|sham focused extracorporeal shock wave therapy|40 Patients with mild to moderate CTS will be randomized to receive either fESWT (1-session a week for 3 weeks) or sham fESWT(1-session a week for 3 weeks). All subjects will be asked to wear night splints.
15817805|NCT04302909|Other|night splint|40 Patients with mild to moderate CTS will be randomized to receive either fESWT (1-session a week for 3 weeks) or sham fESWT(1-session a week for 3 weeks). All subjects will be asked to wear night splints.
15817806|NCT04302896|Drug|dolutegravir oral tablet 50mg|"Tivicay® (dolutegravir, DTG), a HIV-1 integrase strand transfer inhibitor (INSTI), is FDA-approved in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and in pediatric patients weighing at least 30kg. Tivicay® 50mg tablets [GlaxoSmithKline] are yellow, round, film-coated, biconvex tablets debossed with SV 572 on one side and 50 on the other side. The inactive ingredients in each tablet are D-mannitol, microcrystalline cellulose, povidone K29/32, sodium starch glycolate, and sodium stearyl fumarate. The tablet film-coating contains the inactive ingredients iron oxide yellow macrogol/PEG, polyvinyl alcohol-part hydrolyzed, talc, and titanium dioxide."
15817807|NCT04302896|Drug|emtricitabine/tenofovir alafenamide oral tablet 200mg/25mg|"Descovy® (emtricitabine/tenofovir alafenamide, FTC/TAF) is a combination of two HIV nucleoside analog reverse transcriptase inhibitors (NRTIs) FDA-approved in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients weighing at least 35kg. Descovy® 200 mg/25 mg tablets [Gilead] are blue, rectangular-shaped, and film-coated with GSI debossed on one side and 225 on the other side. The inactive ingredients are croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The tablets are film-coated with a coating material containing indigo carmine aluminum lake, polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide."
15817853|NCT04302558|Device|SHAM Blood Flow Restriction (BFR) cuff|Inflatable cuff, similar to a blood pressure cuff, applied to the proximal aspect of the femur of the affected lower extremity with limited inflation pressure to not occlude blood flow
15817808|NCT04302896|Drug|tenofovir disoproxil fumarate oral tablet 300mg|"Viread® (tenofovir DF, TDF) is a nucleotide analog HIV-1 reverse transcriptase inhibitor and a hepatitis B reverse transcriptase inhibitor FDA-approved for the treatment of HIV-1 infection in combination with other antiretroviral agents and for the treatment of chronic hepatitis B in adults and pediatric patients 2 years of age and older weighing at least 10kg. Viread® 300mg tablets [Gilead] are almond-shaped, light blue, film-coated tablets containing 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil, are debossed with GILEAD and 4331 on one side and with 300 on the other side. The inactive ingredients in each tablet are croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and pregelatinized starch. Viread® 300mg tablets are coated with Opadry II Y-30-10671-A, which contains FD&C blue #2 aluminum lake, hypromellose 2910, lactose monohydrate, titanium dioxide, and triacetin."
15817809|NCT04302896|Drug|lamivudine oral tablet 300mg|"Lamivudine (Epivir®, 3TC) is a nucleoside analogue reverse transcriptase inhibitor FDA-approved in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients at least 3 months of age. Lamivudine 300mg tablets [Apotex Inc.] are gray, modified diamond-shaped, film-coated, and engraved with LMV 300 on one side and APO on the reverse side. Inactive ingredients are black iron oxide, colloidal silicon dioxide, crospovidone, hydroxypropyl cellulose, hydroxypropyl methylcellulose, lactose anhydrous, magnesium stearate, polyethylene glycol, and titanium dioxide."
15817810|NCT04302883|Diagnostic Test|Transesophageal Echocardiography (TEE)|Ultrasound of heart chambers via esophagus
15817811|NCT04302883|Diagnostic Test|Flexible Endoscopic Evaluation of Swallowing|Endoscopical swallowing study
15817812|NCT04302870|Drug|Memantine Hydrochloride Oral Solution|Memantine hydrocholoride taken once daily
15817813|NCT04302870|Drug|Trazodone Hydrochloride oral solution|Trazodone Hydrochloride taken once daily
15817814|NCT04302870|Drug|Placebo oral solution|Placebo taken once daily
15817815|NCT04302857|Other|routine MRI|MRI with routine DTI sequence
15817816|NCT04302844|Behavioral|Imago Relationship Therapy|Imago relationship therapy (IRT) involves learning the Imago dialogue process, which helps couples understand more clearly why they and their partners react as they do. Couples practice communicating in a manner that helps them move from reactivity and blame to understanding and empathy. The dialogue is used to transform conflicts into opportunities for healing and growth, and to connect more deeply and effectively with one another. Specific topics of therapy are determined by the couple's needs and goals. In general, the therapist helps them use the Imago dialogue to promote understanding, heal painful emotions, and make requests of one another to change behaviors. In effort to minimize risk of exposure to the virus that causes COVID-19, since the spring of 2020, therapy sessions will be conducted via telehealth, with a HIPAA-compliant audio/visual platform, and with couples at home or in another private place during the therapy sessions and the therapist in his or her office.
15817817|NCT04302844|Behavioral|Waitlist with Bibliotherapy followed by Workshop|"Participants assigned to this group will be asked to wait for 12 weeks before receiving any intervention, and will be given a relationship-focused self-help book to read, with exercises to practice, during that time. After 12 weeks and the 12-week assessment has been completed, couples will attend an educational workshop that provides the principles and communication skills of Imago Relationship Therapy, typically in a weekend format that is usually about 18-20 hours. The workshops, called Getting the Love You Want (GTLYW), are led by certified and experienced Imago workshop presenters, and are attended by a group of couples. The workshop includes presentations, discussions, and practice of communication exercises. Participation in the workshops will also be virtual or via telehealth, as described above."
15817818|NCT04302831|Behavioral|Strength training|weight lifting to increase muscle strength
15817819|NCT04302831|Behavioral|Endurance training|treadmill walking to increase endurance
15817820|NCT04302831|Behavioral|Flexibility training|stretches to improve flexibility
15817821|NCT04302831|Behavioral|Physical activity behavioral intervention|Intervention to encourage participants to be more physically active
15817822|NCT04302831|Behavioral|Task Specific timing and coordination training|stepping and walking patterns to improve timing and coordination of gait
15817823|NCT04302818|Behavioral|SKOLKONTAKT|N=21 participants are offered manualized and structured group training SKOLKONTAKT. The intervention includes 12 weeks, 3 sessions (50 minutes) per week.
15817824|NCT04302818|Behavioral|Social activity group|N=21 participants. The active comparison group includes 12 weeks, 3 sessions (50 minutes) per week. Sessions will include socially oriented activities such as board games, sports or baking as well as a recommended, general agenda.
15817825|NCT04302805|Drug|Privigen|Patients randomized to PE/rATG/IVIG group will receive IVIG 0.5g/kg infusions, on 1st, 3rd and 5th postoperative day.
15817826|NCT04302805|Drug|Thymoglobulin|All patients will receive 1.5 mg/kg intraoperatively and 1 mg/kg when possible daily within first week up to cumulative dose 5-7 mg/kg.
15817827|NCT04302805|Other|Plasma Exchange|All patient will undergo Plasma Exchange before transplantation.
15817828|NCT04302792|Behavioral|Texture-modified foods for cancer patients (Stage 2)|Participants (cancer patients that require texture-modified foods) will be expected to evaluate a maximum of three meals over a 2-weeks period.
15817829|NCT04302792|Behavioral|Taste-optimised foods for cancer patients (Stage 3)|Participants (cancer patients with taste & smell alterations) will be expected to evaluate three foods at home over a period of one month.
15817830|NCT04302779|Behavioral|Solid Model|Cupcakes will be used, with the amount of protein varied to study the effect on perception of the products (using sensory methods rating drying and discrimination tests 'which is the stronger in drying'). Measuring mucoadhesion via protein content remaining in saliva samples following consumption of cupcakes.
15817831|NCT04302779|Behavioral|Liquid Model|To study the perception of whey protein beverages using repeated consumption sensory methods (e.g. rating mouthdrying over repeated sips of the drink).
15817832|NCT04302766|Drug|Remdesivir|Remdesivir (RDV,GS-5734) is a monophosphoramidate prodrug of an adenosine analog with potent activity against an array of RNA virus families including Filoviridae, Paramyxoviridae, Pneumoviridae, and Orthocoronavirinae, through the targeting of the viral RNA dependent RNA polymerase (RdRp).
15817854|NCT04302545|Procedure|Cystoinflation|Bladder retrofill with 300cc saline to distend the bladder to recognize bladder outline
15817855|NCT04302532|Drug|Coenzyme Q10|antioxidant used to decrease oxidative stress and improve fertility prospects
15817833|NCT04302740|Behavioral|LEAP|The LEAP is a comprehensive, multidimensional, community-level intervention offered in Housing First settings that was developed using a CBPR framework. The LEAP principles, process, and components were conceptualized and operationalized by the CAB in the pilot study, and are outlined in a recently published articles in the American Psychologist and Journal of Community Psychology. Briefly, LEAP principles include recognizing and respecting community as a key unit of identity versus solely as individuals in a traditional research hierarchy; embracing cultural humility; practicing pragmatism and compassion; aiming to build equitable research partnerships with communities; acknowledging and promoting community strengths; and supporting relevant, sustainable, positive and community-led change.
15817834|NCT04302727|Behavioral|Med-South Weight Loss Intervention|Phase I is a 4-month lifestyle program focused on the basics of healthy eating. Phase II (8 months) focuses on weight loss, followed by a year-long (Phase III) focused on weight loss maintenance. In Phase I, the main counseling sessions happen at monthly visits, with added check-in phone calls. In Phase II, the main counseling sessions will occur weekly for 6-8 weeks. There are also check-in phone calls - number based on weight loss progress. During Phase III, there are 2 main visits and follow-up phone calls. Counseling visits will be in-person with a health counselor and by phone. Of the 14 core counseling sessions, the in-person format will be required for only 4 (the 1st session of each Phase and after 2 months of the weight loss program). The program also includes brief phone calls to check on progress towards goals for lifestyle change. The number of phone calls will depend on success in meeting personal weight loss goals in Phase II or keeping the weight off in Phase III.
15817835|NCT04302727|Behavioral|WW|If participants are randomized to WW™, they will have access to both the workshop and digital components of the WW™ program for 2 years. The workshop component includes the option of attending weekly group meeting at a WW™ studio (local WW™ office). The digital component can be accessed using the WW™ website or the smart phone App. The study research staff will provide basic instructions on how to use the WW™ digital resources.
15817836|NCT04302714|Procedure|Hysteroscopic injection|Hysteroscopic injection
15817837|NCT04302714|Procedure|Cervical injection|Cervical injection
15817838|NCT04302701|Other|Dichoptic treatment using virtual reality|Dichoptic visual training will be performed with the patient wearing his spectacles using the computer game included in Vivid Vision (Vivid Vision, San Francisco, USA) which will be run in the Oculus Rift OC CV1 virtual reality head mounted display (Oculus VR, Menlo Park, California, USA). Each subject will have 20 treatment sessions, divided into 1 hour-sessions performed twice a week for 10 weeks. Each session will be 60 minutes. Adherence to the treatment regimen will be assessed by the number of hours spent in training at the end of 5th week.
15817839|NCT04302701|Other|Patching|Patients in the control group will be instructed to continue wearing spectacles if required. Patients will be prescribed two continuous hours of daily patching with at least one hour of near activities during patching. Adhesive skin patches will be provided by the study. The parent/patient will be instructed to spend at least one of the hours of patching time each day performing eye-hand coordination activities at near.
15817840|NCT04302675|Behavioral|Prevention, Maternal Immunization|"This intervention will be focused on behavior change, both through providers gaining context, knowledge, confidence, and skills in talking to pregnant mothers about vaccination during pregnancy, but also with patients having increased knowledge about immunization issues, and decreased anxiety about getting vaccinated.
~There is only one intervention arm in this study, and this study is looking at prevention in a pre-post feasibility study."
15817841|NCT04302662|Drug|MS1819-SD|Patients will receive increasing doses from the lowest to a maximum dose of MS1819-SD on top of a stable dose of PPEs. The total treatment phase will range from 39 to 51 days.
15817842|NCT04302649|Drug|peritoneal dialysate at 37°C temperature|during a PET test, patients received peritoneal dialysate warmed at 37°C before infusion
15817843|NCT04302636|Dietary Supplement|Low glycemic index diet|The LGIT diet of the experimental group consisted of 55% fat, 30% protein and 15% carbohydrate, and the glycemic index of the food was limited to less than 50. The meal was prepared by a public nutritionist who evaluated the nutritional composition of the inpatients provided by the canteen and then added or subsumed the compound nutrition powder.
15817844|NCT04302623|Behavioral|Yoga|Upa Yoga program consisting of physical postures, breathing techniques, chanting, and meditation.
15817845|NCT04302610|Device|Heat and Moisture Exchange mask (ColdAvenger® expedition balaclava, USA,|A heat and moisture exchange mask will warm and humidify inspired air and therefore reduce airway heat and water loss during exercise. This will potentially reduce the incidence of and severity of EIB and may also have the potential to decrease the incidence of cough amongst athletes engaging in sports in cold dry environments
15817846|NCT04302610|Device|Sham treatment|Same as the HME mask but active HME parts withdrawn from devices and multiple holes made in mouth piece to improve ventilation of mask and reduce HME ability of mask
15817847|NCT04302597|Procedure|Staples|Skin closure using surgical stapler.
15817848|NCT04302597|Procedure|Tissue adhesive|Skin closure using 2-octylcyanoacrylate tissue adhesive.
15817849|NCT04302584|Drug|norepinephrine / Vasopressin|• The drug infusion was prepared as 100 IU of AVP (Pressyn; Ferring Inc., Toronto, Ontario, Canada) in 250 ml D5W, infused at the rate of 4.5 ml/h for 0.03 IU/min and 15 mg of Norepinephrine (Arterenol; Sanofi-Aventis, Frankfurt, Germany) in 250 ml D5W infused at the rate of 10 ml/h for 10 mcg/min using infusion pump.
15817850|NCT04302571|Behavioral|combined aerobic and resistance physical activity|Five training sessions weekly for 12 weeks are scheduled. Each session lasts 60 minutes divided into 45 minutes of aerobic workout and 15 minutes of circuit training. The aerobic workout consists of walking on a flat floor or on a slight uphill (maximum slope 3%): patients should walk until submaximal walking capacity (80% of their MWT) and rest as they would experience pain at the lower limbs; afterwards, they should start to walk again, once the pain was improved. Resistance training consists of calisthenics exercises focused on trunk and lower limbs muscles (bicycle, flutter kicks, squats, lunges, calf raises, wall sits and power press) with at least 3 repetitions for each exercise, interspersed by 30 seconds recovery. Duration of repetitions increases every 3 weeks.
15817851|NCT04302571|Behavioral|sham exercise|general recommendation to perform regular aerobic physical activity
15817852|NCT04302558|Device|Blood Flow Restriction (BFR)Cuff|Inflatable cuff, similar to a blood pressure cuff, applied to the proximal aspect of the femur of the affected lower extremity inflated to occlude blood flow
15817856|NCT04302532|Drug|clomiphene citrate|ovulation induction drug
15817857|NCT04302519|Biological|Dental pulp mesenchymal stem cells|On the basis of clinical standard treatment, the injection of dental mesenchymal stem cells was increased on day 1, 3 and 7 of the trial.
15817858|NCT04302493|Behavioral|Mindfulness Based Stress Reduction (MBSR)|Participants randomized to the MBSR arm will undergo a standard 8 week course of MBSR taught by a psychologist trained in the MBSR protocol and encouraged to engage in additional individual mindfulness sessions using a cell phone application.
15817859|NCT04302493|Behavioral|Stroke Support Group (SSG)|As a control group, participants randomized to the SSG arm will participate in 8 weeks of weekly Stroke Support Group sessions to experience activity and socialization without additional mindfulness training.
15817860|NCT04302480|Other|Worksheets for ASP|The ASP intervention will cover the harms and misleading marketing strategies of ASPs and other related information.
15817861|NCT04302480|Other|Worksheets for SSB|The SSB intervention will cover the general information on SSBs, such as the sugar content of SSBs, nutrition labels and the harms of SSBs.
15817862|NCT04302480|Other|E-messages for ASP|In the subsequent month after the main intervention, students in the ASP group will receive 4-6 e-messages on ASPs, after which students will be invited to complete a 1-month follow-up assessment.
15817863|NCT04302480|Other|E-messages for SSB|In the subsequent month after the main intervention, students in the SSB group will receive 4-6 e-messages on SSBs, after which students will be invited to complete a 1-month follow-up assessment.
15817864|NCT04302467|Procedure|fluid therapy during operation|ERAS protocol of lobectomy will implemented to all the participants during perioperation,two groups of participants will be given different intraoperative fluid therapy strategy.
15817865|NCT04302454|Radiation|Radiotherapy|Radiotherapy
15817866|NCT04302454|Drug|Leuprorelin|Hormonal therapy
15817867|NCT04302441|Drug|Vinorelbine|vinorelbine 25mg/m2 on day 1 and 8,every 3 weeks
15817868|NCT04302441|Drug|Capecitabine|Capecitabine 1000mg/m2, po, bid, d1-d14, 21 days per cycle
15817869|NCT04302428|Biological|Serum Zn|The investigators will obtain an additional 2 mL of blood in an extra tube. This will be collected at the same time blood is collected for the participant's yearly CF screening labs so as to minimize additional needle sticks.
15817870|NCT04302428|Biological|Red Blood Cell Zn|If the participant is greater or equal than 5 kg, an additional 2 mL of blood will be obtained in an extra tube. This will be collected at the same time blood is collected for the participant's yearly CF screening labs so as to minimize additional needle sticks.
15817871|NCT04302415|Drug|There is no other intervention, only clinical treatment.|There is no other intervention, only clinical treatment.
15817872|NCT04302402|Drug|Rifaximin|Rifaximin has been demonstrated in multiple IBS studies, through a postulated effect on the gut microbiota, to improve the symptoms of pain and bloating, which are important symptoms in subjects with functional dyspepsia
15817873|NCT04302402|Drug|Placebo|Similar looking placebo
15817874|NCT04302389|Behavioral|myWW App, Virtual Workshops, and Private Facebook Group|The 6-month intervention includes the use of WW's mobile app, weekly virtual workshops, and a private online community. Participants are given a personalized food plan based on expert healthy eating guidelines and the latest nutritional science, an activity plan designed to promote regular physical activity and techniques to help shift members towards a helpful mindset for lasting change all within the WW app. Participants will attend weekly virtual workshops led by an expert WW Coach. The coach will help with goal setting, overcoming setbacks, and follow-up on progress toward goals each week. Participants will be encouraged to participate in a private Facebook group that gives participants an opportunity to receive motivational support from each other. Participants can post about their journey through photos, videos, and comments.
15817875|NCT04302376|Diagnostic Test|Cather-related thrombosis ultrasonography|Doppler and compression ultrasound to detect catheter-related thrombosis
15817876|NCT04302363|Other|Fecal microbiota detection and exfoliated cell gene detection|Fecal microbiota detection and exfoliated cell gene detection
15817877|NCT04302350|Procedure|nitrous oxide|During one-lung ventilation with an open chest, the nonventilated lung collapses initially due to elastic recoil, which quickly brings the lung down to its closing capacity. Remaining gas in the lung is then removed by absorption into the pulmonary capillary blood. The rapid diffusion properties of N2O（Blood gas distribution coefficient is 0.47）would be expected to speed lung collapse and so facilitate surgery. The previous study suggested that increasing the concentration of N2O in mixtures of N2O/O2 will lead to a faster rate of collapse. When using nitrous oxide in oxygen during lung ventilation, ongoing oxygen uptake by blood shunting will serve to increase the partial pressure of nitrous oxide in parts of the lung that are still expanded. This will soon result in a partial pressure gradient for nitrous oxide uptake also, with a consequent faster rate of lung collapse than would occur in a patient being ventilated with 100% oxygen.
15817878|NCT04302337|Procedure|Curettage adenoidectomy with transoral endoscopic ablation|Transoral endoscopic examination of nasopharynx at the end of cold curettage adenoidectomy, and, if found, ablation of residual tissue.
15817879|NCT04302337|Procedure|Conventional cold curettage adenoidectomy|Conventional cold curettage adenoidectomy without endoscopic examination for residual tissue.
15817880|NCT04302324|Drug|Daratumumab|Given as 1800mg via injection
15817881|NCT04302324|Drug|Clarithromycin|Given as 500mg oral capsule
15817882|NCT04302324|Drug|Pomalidomide|Given as 4mg oral capsule
15817883|NCT04302324|Drug|Dexamethasone|Given as 20mg IV and 20mg or 40mg oral capsule.
15817884|NCT04302311|Diagnostic Test|Holter monitoring|Use of smart device application and technologies to assess for arrhythmias
15817885|NCT04302311|Diagnostic Test|Kardia/AliveCor monitoring|Kardia/AliveCor monitoring
15817886|NCT04302298|Device|Virtual Reality|A machine which immerses the participant in a simulated environment where they can perform a procedure.
15817887|NCT04302285|Other|PKU type meal and Exercise|"Exercise was conducted prior to PKU type meal.
~PKU type meal was based on PKU special low protein foods (50% of total energy intake), natural free protein foods (37%) and protein substitute (13%). Calories provided in breakfast were 600 kcal and were not based on individual dietary requirement. 65% of total energy intake was provided from carbohydrate, 13% from protein and 22% from fat."
15817909|NCT04302077|Other|virtual doctor visit|interactive live-video feed at home through EPIC
15817910|NCT04302077|Other|Standard care doctor's visit|In person visit as per standard of care
15817888|NCT04302285|Other|PKU type meal|PKU type meal was based on PKU special low protein foods (50% of total energy intake), natural free protein foods (37%) and protein substitute (13%). Calories provided in breakfast were 600 kcal and were not based on individual dietary requirement. 65% of total energy intake was provided from carbohydrate, 13% from protein and 22% from fat.
15817889|NCT04302272|Device|Spiration Valve System (SVS)|Spiration Valves are one-way endobronchial valves indicated for adult patients with shortness of breath and hyperinflation associated with severe emphysema in regions of the lung that have evidence of low collateral ventilation. The Spiration Valve is loaded in the deployment catheter, then passed through the channel of a flexible bronchoscope and deployed at the intended target location. The SVS device is designed to relieve the symptoms of shortness of breath and hyperinflation associated with severe emphysema without surgery.
15817890|NCT04302259|Device|Intelligent Spine Interface|"ISI-C is a bi-directional, two anatomical location Epidural Electrical Stimulation (EES) system to bridge the lesion core in patients with chronic complete and incomplete spinal cord injury (SCI). This Intelligent Spine Interface, or ISI will interpret recorded neural information from above a spinal cord lesion and transfer that information, via deep neural network-based interpreters (i.e. models), to stimulation sites (electrodes) below the lesion with the aim of restoring volitional control of the lower limb."
15817891|NCT04302246|Genetic|Biological testing on sequential blood sample|Biological characterization of various immune function and blood circulating leukocytes phenotyping before liver transplantation and therafter at day-3, -7, -14 postoperatively and if septic complication occurs.
15817892|NCT04302233|Other|New pharmaceutical support (NPS)|The only difference between these 2 groups is that patients in the NPS group benefit from additional visual and oral information on the characteristics of their implant and on medical device vigilance during their hospitalization.
15817893|NCT04302207|Behavioral|De-implementation Strategy for Bronchiolotis|De-implementation strategy to reduce over-use of treatments for patients with bronchiolitis
15817894|NCT04302194|Dietary Supplement|phenylalanine restricted diet|Infants with hyperphenylalaninemia on special formula and diet
15817895|NCT04302181|Drug|Ropivacaine injection|6.5cc of Ropivacaine HCl 0.5%, one time into the stellate ganglion
15817896|NCT04302168|Dietary Supplement|Choline supplement|Choline 470mg twice daily for 8 weeks.
15817897|NCT04302168|Dietary Supplement|Placebo|Placebo pill twice daily for 8 weeks
15817898|NCT04302155|Other|balance-specific -games focusing on dynamic aspects of COP on Wii fit system.|"The participants were randomly assigned into two groups interventional and control. Total 18 minutes session was given to both groups wii fit group and traditional balance training group. All participants were given 3 sessions per week for 6.
~Total 48 participants were initially accessed initially for eligibility , 13 participants were excluded because of having good balance and good balance age score on Wii fit assessment, 35 participants were recruited for balance training. These participants were randomly divided into Wii fit and traditional training group through sealed enveloped method 18 participants was recruited in Wii fit group and 17 in traditional balance training group. 3 participants drop out from Wii fit group and 2 from traditional balance training group.
~Some examples include catching apples in a basket ,moving a golf ball around barriers towards a hole , popping rising balloons/bubbles and air hockey ."
15817899|NCT04302155|Other|mini trampoline and inflatable discs group|"High skipping and landing on a limb every time (2 repeats of 45 s each leg).Standing on one leg and try to catch the ball thrown at them in various directions by the researcher (2 repeats of 45 s each leg) Exercises in inFlated rubber hemisphere attached toa rigid platform (BOSU)
~Standing on BOSU's round soft surface with one foot, in an attempt to maintain balance (2 repeats of 45 s each leg).
~Standing on BOSU's round soft surface with one foot, in an attempt to maintain balance, while lifting the non-support leg forward and backward (2 repeats of 45 s each leg).
~Standing on BOSU flat hard surface with both legs, in an attempt to maintain balance (3 minutes on both legs).
~Standing on BOSUs flat hard surface with both feet, in an attempt to maintain balance, while trying to catch the ball thrown at them by the experimenter in various directions (3 minutes on both leg)"
15817900|NCT04302142|Device|ventilation with critical intracuff pressure (Pcr)|Once the intra-cuff pressure is measured and recorded, the cuff will be deflated by drawing the air 0.5ml per step with each step lasting 3 breaths until a leak, in which a 10% reduction in expiratory volume over the inspiratory tidal volume, is detected.Cuff will then be reinflated until the expiratory tidal volume reaches the inspiratory tidal volume and the discrepancy between the inspiratory and expiratory tidal volume is less than 10 percent. If the intra-cuff pressure applied by the anesthesia care team is inadequate and the discrepancy between the inspiratory and expiratory tidal volume is 10% or greater, the cuff will be further inflated with air 0.5ml per step with each step lasting 3 breaths until it reaches Pcr. This Pcr will be maintained during the entire anesthesia time until extubation.During the course of surgery, if any leak is detected, the cuff will be re-inflated by 0.5ml of air until the leak is not detectable.
15817901|NCT04302142|Device|ventilation with critical intracuff pressure (Pcr)|Pcr is obtained just as it is done in the intervention group. The cuff will then be reinsufflated to the actual cuff pressure the care team initially chose. The care team will be blinded to the measured critical cuff pressures and hence will maintain the usual level of intracuff pressure in the control group during the entire anesthesia time.
15817902|NCT04302129|Procedure|Erector spinae plane block|20 ml local anaesthetic are injected bilaterally on each side of the surgical incision underneath the erector spinae muscle where the dorsal rami pass around the bases of the transverse processes.
15817903|NCT04302129|Drug|Multimodal analgesia|Ketorolac 0.75 mg/ Kg and paracetamol 10 mg/ Kg intravenously
15817904|NCT04302116|Drug|Combination therapy with vigabatrin and prednisolone|High dose prednisolone (40 - 60 mg/day) for 1 month combined with vigabatrin treatment (50-150 mg/kg/day) twice daily for 4 months
15817905|NCT04302116|Drug|Vigabatrin Tablets|Vigabatrin (50-150 mg/kg/day) twice daily for 4 months
15817906|NCT04302103|Biological|RC18 160mg|subcutaneous injection
15817907|NCT04302103|Biological|RC18 240 mg|subcutaneous injection
15817908|NCT04302090|Other|Regulated expiratory method|This method was originally a postpartum abdomino-perineal rehabilitation technique. It allows a functional abdominal rehabilitation by combining a regulated breath in a specific mouthpiece and an abdominal stimulation triggered by this same breath. The use of this method was extended to labor and childbirth. In fact, the application of the method during labor is based on the use of a flow regulating device (Winner Flow + URO-MG®). By regulating the flow of breath during a uterine contraction, it allows better pain management.
15817913|NCT04302051|Diagnostic Test|Thermo-acuostic image acquisition of liver|Estimation of hepatic fat content with thermo-acoustic device
15817914|NCT04302051|Diagnostic Test|MRI-PDFF estimation of hepatic fat|Estimation of hepatic fat content with MRI
15817915|NCT04302038|Dietary Supplement|Protein|Additional daily protein provided by potato protein.
15817916|NCT04302038|Dietary Supplement|Placebo control|No additional dietary protein (outside of 0.8 g/kg/day as provided by diet)
15817924|NCT04302012|Procedure|Color fundus photography|Subjects will undergo fundus photography before and/or after administration of mydriatic agent
15817925|NCT04302012|Drug|Mydriatic Agent|Subjects may be administered mydriatic medication to dilate their pupils.
15817926|NCT04301999|Procedure|Photodynamic therapy|The PDT optical fiber was inserted through the dilation catheterand advanced toward the bile duct stenosis point under visualradiography. The dilation catheter was then withdrawn to leavethe PDT optical fiber directly across the stricture. Photoactivation was performed at 640 nm using a diode laser at a light dose of 180 J/cm2at power density of300 mW/cm2 and irradiation time of 600 s.
15817927|NCT04301999|Procedure|radiofrequency ablation|an RFA electrode (Habib EndoHPB, EMcision, HitchinHerts, UK) was advanced along the guide wire into the bile duct and to the biliary stricture under X-ray fluoroscopic guidance. A 400 kHz RF generator (RITA 1500X, Angio Dynamics, USA) was connected for RFA at 7-10 W for 90 seconds.
15817928|NCT04301986|Device|Cytosponge|In a seated position, subjects will swallow the Cytosponge capsule with 150-250 mL of water. Seven minutes and 30 seconds to ten minutes after ingestion, the sponge is then withdrawn by gentle traction on the suture. After retrieval, the string is cut and the retrieved foam sphere containing the cytological specimen is immersed in fixative and stored refrigerated (1° to 12°C [34° to 54°F]).
15817929|NCT04301986|Device|Transnasal Endoscopy (TNE)|In an upright position, the scope will be inserted via the nares to examine the posterior pharynx, esophagus and proximal stomach with the transnasal endoscopy approach. The scope will be withdrawn from the nares following completion of the exam.
15817930|NCT04301986|Device|Esophagogastroduodenoscopy|Laying on the subjects' left side, the flexible endoscope is inserted through the mouth to allow visualization of the esophageal mucosa from the upper esophageal sphincter all the way to the esophagogastric junction (EGJ).
15817931|NCT04301973|Other|Stool collection|There is no intervention with a product in this study. The healthy subject has just to come 2 times in the clinical trial unit for clinical exam including urinary pregnancy test, fill life habits and diet questionnaires, and provide one stool sample for the 2nd visit, after 2 weeks of alimentary restrictions.
15817932|NCT04301960|Other|Single task training|The single task group includes balance gaining and cognitive training. The single task group will have 30-40 minutes of single-task training for 3 sessions per week for 8 weeks.
15817933|NCT04301960|Other|Dual task training|The dual-task group includes CSRT Mat training. The dual-task group will have CSRT Mat training for 30-40 minutes of dual-task training for 3 sessions per week for 8 weeks.
15817934|NCT04301947|Other|Standard warm-up protocol|Stationary cycling and lower limb stretching exercises
15817935|NCT04301947|Other|Gluteal activation warm-up protocol|Standard warm-up protocol + Clam exercise (3 sets of 12 repetitions each)
15817936|NCT04301934|Device|Mona Lisa Touch|Fractional CO2 LASER
15817937|NCT04301934|Drug|Conjugated estrogen|Current standard treatment for recurrent UTIs in postmenopausal women
15817938|NCT04301934|Drug|Estradiol|Current standard treatment for recurrent UTIs in postmenopausal women
15817939|NCT04301921|Other|Traditional punkcture site and No anticoagulation|Traditional punkcture site and No anticoagulation
15817940|NCT04301921|Other|Traditional punkcture site and ACT-guided anticoagulation|Traditional punkcture site and ACT-guided anticoagulation
15817941|NCT04301908|Drug|interferon|Antiviral therapy for patients with chronic hepatitis B and cirrhosis. Antiviral therapies included interferon and / or nucleoside (acid) analogs, and patients who were continuously treated for more than 6 months were included in the study.
15817942|NCT04301895|Behavioral|Continuous conversational interaction|Maintaining continuous conversation, requiring that the subject answer questions and engage in discussion without interruption.
15817943|NCT04301895|Drug|Remifentanil infusion|10 minute remifentanil infusion
15817944|NCT04301882|Drug|interferon combined with ribavirin (PR) antiviral therapy|Patients with chronic hepatitis C treated with interferon combined with ribavirin (PR) antiviral therapy (PR therapy greater than or equal to 6 months)
15817945|NCT04301882|Drug|direct antiviral drugs (DAAs)|Patients with chronic hepatitis C treated with direct antiviral drugs (DAAs)
15817946|NCT04301869|Drug|Antibiotics|Oral versus intravenous therapy
15817947|NCT04301856|Drug|CFTR Modulators|CFTR modulators as recommended in routine care by the french health authorities
15817948|NCT04301843|Drug|Eflornithine|DFMO (difluoromethylornithine) will be given at a dose of 1000 mg/m2 BID on each day of study.
15817949|NCT04301804|Drug|SHR6390|a selective small-molecule CDK4/6 inhibitor
15817950|NCT04301791|Other|nutritional status|impact of nutritional status on clinical outcome of children admitted in PICU
15817951|NCT04301778|Drug|Durvalumab|"Durvalumab - 1500 mg via IV infusion over 60 minutes (-5/+10 min) on day 1 of each 28-day cycle (every 4 weeks).
~Drug - 1500mg IV"
15817952|NCT04301778|Drug|SNDX-6352|"SNDX-6352 - 3mg/kg via IV infusion over 30 minutes (-5/+10 min) on days 1 and 15 of each 28-day cycle (every 2 weeks), starting with cycle 2 (not given during cycle 1).
~Drug - 3mg/kg IV"
15817953|NCT04301765|Drug|testosterone 1.62% gel|The gel will be applied daily by the participants (all participants will be trained in the application process and will be given printed instructions). The intervention will be for 6 months
15817954|NCT04301765|Other|placebo gel|The gel will be applied daily by the participants (all participants will be trained in the application process and will be given printed instructions). The intervention will be for 6 months
15817955|NCT04301752|Diagnostic Test|MoCA|Cognitive function was assessed by using MoCA score. Cognitive impairment was considered present when MoCA scores were <26. Maximum score is 30.
15817956|NCT04301739|Drug|HLX10|HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.
15817957|NCT04301739|Drug|nab-paclitaxel, carboplatin, doxorubicin or epirubicin and cyclophosphamide|chemotherapeutics
15817958|NCT04301739|Drug|Placebo|Placebo
15817959|NCT04301726|Drug|Deutetrabenazine Oral Tablet [Austedo]|The participants randomized to this group will receive oral deutetrabenazine for 8 weeks. Week 1: 6 mg tab once daily; Week 2: 6 mg tab (BID); Week 3: 9 mg tab (BID); Week 4: 12 mg tab (BID); Week 5: 15 mg (6 mg tab + 9 mg tab BID); Week 6: 18 mg (9 mg tab + 9 mg tab BID); Week 7: 21 mg (9 mg tab + 12 mg tab BID); Week 8: 24 mg (12 mg tab BID).
15817960|NCT04301726|Drug|Placebo oral tablet|The participants randomized to this group will receive oral placebo for 8 weeks. Week 1: 6 mg tab once daily; Week 2: 6 mg tab (BID); Week 3: 9 mg tab (BID); Week 4: 12 mg tab (BID); Week 5: 15 mg (6 mg tab + 9 mg tab BID); Week 6: 18 mg (9 mg tab + 9 mg tab BID); Week 7: 21 mg (9 mg tab + 12 mg tab BID); Week 8: 24 mg (12 mg tab BID).
15817961|NCT04301713|Other|Evaluation of rik of falls|An evaluation of the risk of falls will be carried out in the elderly in the province of Salamanca. This will attempt to identify the risk of falling as well as to be able to establish protocols for action of a preventive and rehabilitative nature.
15817962|NCT04301700|Behavioral|mindfullness and relaxation|three arms: mindfullness and relaxation
15817965|NCT04301674|Device|Breath Biopsy|ReCIVA breath sampler (Owlstone Medical, Cambridge, UK)
15817966|NCT04301661|Other|Blood collection|Blood will be collected from participants at defined time points during the study to measure drug levels and assess platelet activity.
15817967|NCT04301661|Drug|Abacavir/lamivudine|Participants who are already taking abacavir/lamivudine as part of standard HIV care will continue taking their therapy.
15817968|NCT04301661|Drug|Tenofovir alafenamide/emtricitabine|Participants who are already taking tenofovir alafenamide/emtricitabine as part of standard HIV care will continue taking their therapy.
15817969|NCT04301661|Drug|Switch|Participants who are planning to switch from abacavir/lamivudine as part of standard HIV care will change therapy to per the discretion of their HIV provider.
15817970|NCT04301648|Other|STAR Nurse|"This intervention will consist in that the nurse who is in the hemodynamic nurse's office will do the STAR Nurse's tasks and competences.
~Although the intervention will be detailed through phase 1 (integrative review) and 2 (Delphy methodology).
~It is expected that the main STAR nurse's competencies and tasks in the nurse's office will be:
~To guarantee a comprehensive evaluation and appropriate triage to candidates for an interventional procedure of structural heart disease, coordinating the request for complementary tests and previous visits.
~Make education to the patient and family.
~Make communication bridge with cardiologists.
~Establish specific patient-centered care processes.
~Promote continuity of care after discharge, follow up after discharge, and reevaluate quality of life and fragility."
15817971|NCT04301648|Other|Common Practice|Common practice will consist in that the nurse who is in the hemodynamic nurse's office will do her usual task that is exclusively health education.
15817972|NCT04301635|Procedure|Maxillo-mandibular Advancement + Counterclockwise rotation|Maxilla: Lefort I osteotomy Mandible: Obwegeser-Dal-Pont osteotomy Movements: Advance and counterclockwise rotation
15817973|NCT04301622|Device|Primary Knee implants|Primary knee arthroplasty
15817974|NCT04301609|Dietary Supplement|Active|Take 4 capsules daily (2 capsules on an empty stomach + 2 capsules 30 minutes before dinner).
15817975|NCT04301609|Dietary Supplement|Placebo|Take 4 capsules daily (2 capsules on an empty stomach + 2 capsules 30 minutes before dinner).
15817976|NCT04301596|Other|Collection of data|different set of data will be collected over a 6 months period
15817977|NCT04301583|Dietary Supplement|procyanidin B2 enriched cocoa|Volunteers will intake 5 grams per day of dietary supplement for 10 weeks
15817978|NCT04301570|Device|Ultrasound device|"The measurement of bone age is performed via ultrasound with the Ultrasound System for Bone Age Assessment (BAUS) from Sonic Bone (SonicBone Medical Ltd., Rishon Lezion, Israel)."
15817979|NCT04301570|Radiation|XR|The measurement of bone age is performed via imaging procedure via X-ray (Röntgengerät, Stadler SE 4600, Littau, CH) of the left hand.
15817980|NCT04301557|Drug|PD-1 Antibody|PD-1 antibody 240mg,I.V,D1,repeat every 3 weeks, Four cycles in the neoadjuvant treatment, and four cycles in the adjuvant treatment,
15817981|NCT04301557|Drug|Oxaliplatin|Oxiliplatin 130mg/m^2 (100mg/m^2 during radiotherapy),I.V,D1,repeat every 3 weeks, Four cycles in the neoadjuvant treatment in Capeox regimen, and two cycles in the adjuvant treatment in Capeox regimen
15817982|NCT04301557|Drug|Capecitabine|Capecitabine 1000mg/m^2,Bid,P.O,D1-D14,repeat every 3 weeks, Four cycles in the neoadjuvant treatment in Capeox regimen, and two cycles in the adjuvant treatment in Capeox regimen, and two cycles in adjuvant treatment in Capecitabine regimen
15817983|NCT04301557|Radiation|External beam radiotherapy|Neoadjuvant radiotherapy, 50Gy/25Fractions to the GTV, 45Gy/25Fractions to the CTV
15817984|NCT04301557|Procedure|Total mesorectal excision|Total mesorectal excision
15817985|NCT04301544|Behavioral|INDAK (Improving Neurocognition through Dance and Kinesthetics)|INDAK (Improving Neurocognition through DAnce and Kinesthetics) is a structured modular dance consisting of 8 types of ballroom dances (Reggae, Cha-cha, Samba, Merengue, Bachata, Swing, Tango and Salsa) with increasing complexity. The intervention group will receive dance intervention from a dance teacher two times a week, one hour each time, for 12 months. Each 60-minute session has 3 parts: 10 minutes warm-up/ stretching, 40 minutes dance proper and 10 minutes cool down. This dance intervention will last for 12 months.
15818014|NCT04301375|Drug|Endocrine therapy|Adjuvant endocrine therapy will be administered as per local practice and according to recognized clinical practice guidelines
15817986|NCT04301544|Behavioral|Nutrition Counseling|The dietary advice will follow Filipino Nutrition Research Institute (FNRI) recommendation called Pinggang Pinoy or Filipino Plate, which is a picture of a nine-inch plate with foods proportionally distributed among the food groups to provide approximately 1,200 to 1,500 calories per day. It is advised that half of the plate is composed of green leafy vegetables and one serving of fruit per meal. For fruits, 4 to 6 servings are encouraged per day. In general, affordable nutritious food is recommended: high consumption of local fruits and vegetables, brown/purple rice instead of white rice, coconut oil and other vegetable oils, and fish. Participants will be asked to use structured 3-day meal diary for diet monitoring. Individual counseling sessions depending on identified vascular risks based on FNRI recommendations will also be conducted. This is followed-up by study nutritionists every 3-month of intervention period.
15817987|NCT04301544|Behavioral|Standardized Vascular Care|The management advice for hypertension, diabetes, and dyslipidemia will be based on Filipino standard clinical practice guidelines. This is followed-up by study physicians every 3-month of intervention period
15817988|NCT04301531|Other|Mass testing using RDTs|To determined the prevalence of asymptomatic malaria parasitaemia. In arm 1 all participants will be tested six times over the study period while in arm 2 the participants will be only be tested at baseline and evaluation.
15817989|NCT04301531|Drug|Treatment for all cases confirmed positive malaria cases with ACTs|During each mass testing, all confirmed positive cases are treated in both arms.
15817990|NCT04301531|Other|Determination of Hb|Hb of all children in the subgroup study are measured using a haemocure photometer.
15817991|NCT04301531|Other|Household survey|Determine the prevalence of febrile illnesses among children in the subgroup study
15817992|NCT04301531|Other|Community-base management of malaria|Between interventions, participant who become febrile are tested and treated if confirmed positive for malaria by CHWs
15817993|NCT04301518|Other|Multimodal intervention strategy|"Once weekly nurse support
~200 mg/daily micronized progesterone as vaginal suppository
~81 mg/daily low dose aspirin
~two transvaginal ultrasounds
~cerclage placement if cervical length is less than or equal to 10 mm prior to 24 weeks gestation"
15817994|NCT04301505|Other|Intervention 1|Checklist will be delivered at the beginning of the study. The educational intervention program will consist of a checklist that provides family physicians with COPD management for the elderly.
15817995|NCT04301505|Other|Intervention 2|The same checklist will be delivered at the beginning of the study and repeated after 6 months.
15817996|NCT04301492|Drug|Vortioxetine|16 weeks for each participant. During the first visit a collection of medical and pharmacological history will be collected and ECG, laboratory tests and clinical assessment will be performed. After verifying the absence of significant abnormalities at the ECG and laboratory tests and after confirming all inclusion and exclusion criteria, subjects will perform the second visit to receive study drug (Brintellix drops 20 mg/ml). All subjects will be instructed to take Vortioxetine 1 drop every day after lunch, increasing of 1 drop per day arriving to 10 drops per day. After 5 days from the beginning of treatment, subject will be contacted by phone to check on tolerability and in absence of side effects, the dosage will be increased to 10 drops per day. At Week 4-8-12 patients will return to the site to perform all clinical evaluations required and to receive study drug.
15817997|NCT04301479|Drug|hydrocortisone sodium succinate|Steroid group will receive 200 mg of hydrocortisone diluted in 120 mL of saline at an infusion rate of 5mL/hr for 3 days or shock reversal
15817998|NCT04301479|Drug|Saline|Control group will receive 120 mL of saline solution at a rate of 5mL/hr for 3 days or shock reversal
15817999|NCT04301466|Drug|Qi Zhi Tong Luo capsule|Patients were receiveed Qi Zhi Tong Luo Capsule 4 capsules, 2 times per day for 24 weeks. QZTL capsule, a traditional Chinese medicine. Each capsule was weighted 0.5g.
15818000|NCT04301466|Drug|Placebos|Patients were allocated to placebo, 4 capsules, 2 times per day for 24 weeks.To preserve blinding, the placebo had an identical taste and appearance to the experimental drugs. Placebo (batch number: 20140805) were produced by Shanxi Zhendong Pharmaceutical Co., Ltd.
15818001|NCT04301453|Other|Maternal Scent|Mothers will wear a breast pad during their visit. The breast pad will be placed in the hats of infants for 24 hours.
15818002|NCT04301440|Device|The emission of electromagnetic with the probes|The patient will be in the lying position, a probe will be positioned in the middle of the chest and the second probe below the xyphoid. The probes will be fixed by a band to keep them in place. The emission of electromagnetic waves is painless.
15818003|NCT04301440|Device|The emission of electromagnetic without the probes|The patient will be in the lying position, a probe will be positioned in the middle of the chest and the second probe below the xyphoid. The probes will be fixed by a band to keep them in place. The emission of electromagnetic waves is painless.
15818004|NCT04301427|Other|Bone mineral density|Bone mineral density will be measured twice in all included patients.
15818007|NCT04301401|Other|Vaginal swabs|On the day of the surgical intervention, vaginal swabs will be taken at various stages of surgery: before vaginal disinfection/draping, directly after disinfection/draping, 1 hour after disinfection, 6 weeks after surgery and 12 months after surgery.
15818008|NCT04301401|Other|Stool samples|Stool samples will also be taken (and collected in a pot devoted to coproculture with an airtight opaque bag given to the patient) at the inclusion visit on the day before surgery and also 6 weeks after surgery (in a second pot with an airtight opaque bag given to the patient at the time of being discharged).
15818009|NCT04301401|Other|Urine samples|Urine samples will also be taken before surgery and 6 weeks after surgery.
15818010|NCT04301388|Procedure|Transvaginal ultrasound|Transvaginal ultrasound to measure cervical length if persist regular uterine contraction
15818011|NCT04301375|Drug|Pertuzumab and trastuzumab FDC subcutaneous|Pertuzumab and trastuzumab FDC subcutaneous, A loading dose of 1200 mg pertuzumab and 600 mg trastuzumab followed by a maintenance dose of 600 mg pertuzumab and 600 mg; day 1 of each 3 week cycle during 5 neoadjuvant cycles and 13 adjuvant cycles if complete response
15818012|NCT04301375|Drug|Paclitaxel|80 mg/m2, day 1,8,15 of each 3 week cycle during 4 cycles
15818013|NCT04301375|Drug|TDM1|3,6 mg/kg, 14 adjuvant cycles if not complete response
15818015|NCT04301375|Procedure|Omission surgery|Omission of surgery and sentinel lymph node dissection in patients with HER2-E and ERBB2 high breast cancer who achieving a complete response following standard anti-HER2-based neoadjuvant therapy with paclitaxel/trastuzumab/pertuzumab
15818016|NCT04301362|Diagnostic Test|Thrombosis biomarkers|Blood samples shall be prepared according to the manufacturer's instructions and stored at -80°C until analysis. Thrombin generation will be measured using the commercial kit STG®-Tromboscreen kit (Stago). The D-dimers will be quantified using STA LIATEST® D-DI PLUS (Stago).
15818017|NCT04301349|Drug|vaginal dinoprostone|two tablets of vaginal dinoprostone (6 mg) 3 hours prior to IUD insertion
15818018|NCT04301349|Drug|vaginal misoprostol|two tablets of vaginal misoprostol (400 mcg) 3 hours prior to IUD insertion
15818019|NCT04301349|Drug|placebo|two tablets of placebo given 3 hours prior to IUD insertion
15818020|NCT04301336|Drug|Omega 3|Omega-3 supplementation (300-400mg EPA & 200-300mg DHA) per day for 8 consecutive months up to 10 months
15818021|NCT04301336|Drug|Vit D|"50 patients from each participating hospital that will receive Vit-D medication (1500 IU to 3500 IU ) per day for 8 consecutive months up to 10 months.
~in addition to the experimental treatment, this group will receive the traditional treatment of hydroxyurea, Folic acid, pain killer plus regular blood transfusion with a dose de-escalation methods till efficacy of experimental treatment proved."
15818022|NCT04301336|Drug|Zinc sulfate|"50 patients from each participating hospital that will receive Zinc supplements (15 mg to 50 mg ) per day for 8 consecutive months up to 10 months.
~in addition to the experimental treatment, this group will receive the traditional treatment of hydroxyurea, Folic acid, pain killer plus regular blood transfusion with a dose de-escalation methods till efficacy of experimental treatment proved."
15818023|NCT04301336|Drug|Statins (Cardiovascular Agents)|"50 patients from each participating hospital that will receive Simvastatin orally (20 mg to 40 mg ) per day for 8 consecutive months up to 10 months.
~in addition to the experimental treatment, this group will receive the traditional treatment of hydroxyurea, Folic acid, pain killer plus regular blood transfusion with a dose de-escalation methods till efficacy of experimental treatment proved."
15818024|NCT04301336|Drug|Hydroxy Urea|50 patients from each participating hospital that will receive the ordinary treatment of Hydroxyurea (20 mg/kg/day) with monitoring blood count every 2 weeks maximum daily dose: (40 mg/kg/day) for 8 consecutive months up to 10 months.
15818025|NCT04301336|Drug|Folic Acid Supplementation|Folic Acid dose of 0.5 to 1 mg daily for 3 to 4 weeks until definite hematologic response
15818026|NCT04301336|Drug|Morphine Sulfate|Morphine medication as a pain killer is administered, if Patient weight <50 kg: Opioid naïve: Initial: 0.05 mg/kg/dose; usual maximum initial dose: 1 to 2 mg/dose.
15818027|NCT04301336|Procedure|blood transfusion session|Regular blood transfusion session based on patient hematological profile starts from one session every 2 weeks.
15818028|NCT04301323|Drug|BHVI1 eye drops|Including 35 children enrolled to receive BHVI1 eye-drops once nightly
15818029|NCT04301323|Drug|BHVI2 eye drops|Including 35 children enrolled to receive BHVI2 eye-drops once nightly
15818030|NCT04301323|Drug|BHVI3 eye drops|Including 35 children enrolled to receive BHVI3, combination of BHVI1 and BHVI2, eye-drops once nightly
15818031|NCT04301310|Drug|BMS-986235 (Treatment A)|Specified dose on specified days
15818032|NCT04301310|Drug|Rifampin (Treatment B)|Specified dose on specified days
15818033|NCT04301284|Drug|CAD-1883|150 mg filled capsules
15818034|NCT04301284|Drug|Placebos|capsules
15818035|NCT04301271|Drug|Simvastatin 40mg|12 weeks 40 mg Simvastatin add-on
15818036|NCT04301271|Drug|Placebo oral tablet|12 weeks Placebo add-on
15818037|NCT04301258|Other|Articular cartilage repair|Patient reported outcomes will be collected on patients who have had a cartilage repair procedure using ProChondrix CR in the knee, hip, foot or ankle.
15818038|NCT04301245|Other|Educational program|"The educational program (EP) was offered during the initial session of the pulmonary rehabilitation. According to the french law, patients were free to participate or not.
~The EP consisted of an educational diagnosis, educational workshops and an individual final assessment."
15818039|NCT04301232|Other|Modified Aldrete Scoring System (mASS)|Activity( Moves all extremities, Moves two extremities, Unable to move extremities), Respiration( Breathes deeply, coughs freely, Dyspneic, shallow or limited breathing, Apneic), Circulation (blood pressure) ( 20 mm Hg > preanesthetic level, 20 - 50 mm Hg > preanesthetic level, 50 mm Hg > preanesthetic level), Consciousness (Fully awake, Arousable on calling, Not responding), Oxygen saturation( SpO2 > 92% on room air, Supplemental O2 required to maintain SpO2 > 90%,SpO2 < 90% with O2 supplementation), scoring is done as 2,1,0, respectively. A score of 9 or more would be required for a patient after general anesthesia for discharge
15818040|NCT04301232|Other|White's Fast-Track Scoring System (WFTSS)|Physical activity (Able to move all extremities on command, ,Some weakness in movement of extremities, Unable to voluntarily move extremities),Respiratory stability(Able to breathe deeply,Tachypnea,Dyspneic),Hemodynamic stability; (Blood pressure(MAP)<15%, Blood pressure 15-30%, Blood pressure>30%, Level of consciousness,(Awake&orientated Arousable with minimal stimulation, Responsive only to tactile stimulation),Oxygen saturation status(Maintains value>90% on room air, Requires supplemental oxygen, Saturation<90% with supplemental oxygen), Postoperative pain assessment(None or mild discomfort, Moderate to severe pain controlled with analgesics, Persistent severe pain), Postoperative emetic symptoms(None or mild nausea w/no active vomiting, Transient vomiting or retching, Persistent moderate to severe nausea&vomiting), Scoring is done as 2,1,0, respectively. A minimal score of 12(with no score<1 in any individual category)would be required for a patient after general anesthesia
15818041|NCT04301232|Other|SPEEDS criteria|"Extremity movement (moves all four) Y/N, Stable vital signs( SBP > 90 and < 180, HR > 50 and < 110) Y/N, Dialogue (oriented person/place) Y/N, Oxygen saturation >90% in roExtremity movement (moves all four) Y/N, Stable vital signs( SBP > 90 and < 180, HR > 50 and < 110) Y/N, Dialogue (oriented person/place) Y/N, Oxygen saturation >90% in room air Y/N, Pain Control (VAS < 4) Y/N, Emesis Control Y/N. A patient must have a response of yes to all parameters to progress to phase II recovery"
15818042|NCT04301206|Behavioral|Intervention Group|Empowerment of parents. When calling the medical helpline 1813 the parents will be offered to access the new material about sick children, compared to not getting this possibility.
15818043|NCT04301193|Device|Quantra Analyzer|Subjects blood will be manipulated in the lab and will be tested with the Quantra Analyzer
15818074|NCT04300998|Behavioral|Cognition|Mini-Cognition test: CDT and 3-word recall
15818044|NCT04301180|Device|Education food|The intervention consisted of the presentation of food education content while conducting an orchard with seasonal vegetables
15818045|NCT04301167|Behavioral|befriending|Participants are new users of the ALONE befriending intervention, which matches participants to volunteer befrienders who visit once weekly for a minimum of 12 months. It is a criterion of study involvement that participants commit to completing at least two data collection timepoints before being matched to a befriender.
15818046|NCT04301154|Biological|HIVIS DNA/MVA-CMDR|HIVIS DNA IM by needle-free injection at weeks 0, 4 and 24 followed by intramuscular (IM) needle injection of MVA-CMDR at weeks 36 and 48 in the same arm as HIVIS DNA.
15818047|NCT04301154|Biological|HIVIS DNA ± Cervarix and MVA-CMDR|"Cervarix IM by needle injection followed by HIVIS DNA IM by a needle-free injection device.
~MVA-CMDR IM by needle injection at weeks 36 and 48 in the same arm as HIVIS DNA."
15818048|NCT04301154|Biological|Cervarix|Cervarix by IM needle injection at weeks 0, 4 and 24.
15818049|NCT04301141|Other|Virtual Reality Assisted Cognitive Behavioural Therapy|The intervention will be delivered in NHS services and will involve using VR to assist the delivery of conventional CBT for the treatment of social anxiety in autistic adolescents. Social situations that are commonly anxiety-evoking for this patient group will be simulated in VR and used for exposure (a typical component of CBT for social anxiety). Therapists will use a modular approach involving optional modules such as psychoeducation on anxiety in the context of ASD, managing expectations of outcome and emotional literacy training. Essential modules include rapport building, introducing the use and purpose of VR, and exposure (incorporating VR). Because CBT is delivered in routine clinical practice, the VR exposure sessions will be the main subject of interest.
15818050|NCT04301128|Other|Experimental|Patients in the experimental group were educated and followed with an android based mobile application which contains the informations related to the disease, treatment and its complications, monitoring and cure and provides side effect tracking.
15818051|NCT04301128|Other|control|Patients in the control group were informed same informations verbally and given an education book.
15818052|NCT04301115|Other|attachment|unilateral attachment from rehine 83
15818053|NCT04301115|Other|bridge|tooth implant supported bridge
15818054|NCT04301115|Other|CONVENTIONAL|conventional metalic partial denture
15818055|NCT04301102|Device|Hemosphere platform® together with the FloTrac Acumen IQ® sensor|"Clinical platform that, analyzing the pulse wave contour, obtained from the previously catheterized radial artery, is able to make available to the clinician both a continuous monitoring of blood pressure and advanced hemodynamic parameters that help patient management. It incorporates predictive parameters such as the hypotension prediction index and decision support parameters such as dynamic arterial elastance and maximum dP / dT.
~It also has the possibility of assessing regional oxygen saturation, measured by near-infrared light photoplethysmography, and the sensor can be applied in different locations (cerebral, muscular ...)."
15818056|NCT04301102|Device|Hemosphere platform® together with the FloTrac® sensor|"Clinical platform that, analyzing the pulse wave contour, obtained from the previously catheterized radial artery, is able to make available to the clinician both a continuous monitoring of blood pressure and advanced hemodynamic parameters that help patient management.
~It also has the possibility of assessing regional oxygen saturation, measured by near-infrared light photoplethysmography, and the sensor can be applied in different locations (cerebral, muscular ...)."
15818057|NCT04301089|Device|Pico G2 4K Headset with Applied VR software|headset worn at time points defined in study
15818058|NCT04301076|Drug|Cyclophosphamide|Given IV
15818059|NCT04301076|Drug|Doxorubicin Hydrochloride|Given IV
15818060|NCT04301076|Drug|Etoposide|Given IV
15818061|NCT04301076|Drug|Lenalidomide|Given PO
15818062|NCT04301076|Drug|Prednisone|Given PO
15818063|NCT04301076|Drug|Vincristine Sulfate|Given IV
15818064|NCT04301063|Other|RV3278A|RV3278A is a non-rinsed cosmetic cream intended to be used every day on adolescents and young adults with acne-prone skin.
15818065|NCT04301050|Other|Yoga Intervention|Weekly 75-minute yoga classes.
15818066|NCT04301037|Procedure|Tension band wires|medial malleolus fracture fixed with tension band wiring): 2 k.wires (1.6 mm) are inserted perpendicular to the fracture site. Again the position is checked under image intensification for the correct direction and length. We drilled a 2.5mm hole with a protection sleeve, 2-3cm above the level of the horizontal joint line, aiming the drill bit slightly inferiorly to avoid screw pullout. We inserted a 3.5mm unicortical screw about 30 mm in length (with or without washer), 2-3mm is left for the wire between the bone and screw head before full tightening. A steel wire is constructed into a figure of eight between the screw the reduction k. wires, then twisted to achieve interfragmentary compression
15818067|NCT04301037|Procedure|Cannulated screws|In group 2 (15 patients with medial malleolus fixed by 2 cannulated screws): Two guide wires (1.6mm) are inserted perpendicular to the fracture site, the appropriate length, proper insertion site including the distance from the articular surface is checked fluoroscopically .the length is measured .drilling of the bone through the threaded guide wire with a cannulated drill bit (3.2mm). A two 4.5mm partially threaded cannulated screws (with or two washers) are inserted through the guide to achieve Compression, the guide wires are then removed
15818068|NCT04301024|Other|assessing the nitrous oxide misuse|assessing the nitrous oxide misuse among teenagers consulting in an addioctology center dedicated to young drug users in montpellier
15818069|NCT04301011|Biological|TBio-6517|Engineered Oncolytic Vaccinia Virus
15818070|NCT04301011|Biological|Pembrolizumab|Immune checkpoint inhibitor.
15818071|NCT04300998|Behavioral|Activities of Daily Living/ADLs|7 activities: bathing, dressing, grooming, feeding, walking inside the home, walking outside the home, and bladder and bowel control. Participants get 2 points for each activity that is not limited at all, 1 point for limited a little, and 0 points for limited a lot. Total ADL score ranges from 0 to 14
15818072|NCT04300998|Behavioral|Instrumental Activity of Daily Living|8 activities: telephone use, doing laundry, shopping, preparing meals, doing housework, handling own medications, handling money and finances, and transportation to visit one's doctor. Participants get 2 points for each activity that can be done without help, 1 point for needing some help, and 0 point for being unable to do. Total iADL score ranges from 0 to16.
15818073|NCT04300998|Behavioral|Timed Up and Go|Participants are asked to get up from the chair, walk 10 feet, turn, and walk back to the char (<10 seconds, 10-20 seconds, >20 seconds)
15818075|NCT04300998|Behavioral|Geriatric Depression Scale|Four yes/no questions regarding patient's psychological status. Score ranges from 0 to 4, and a score of >/=1 is usually indicative of depression.
15818076|NCT04300998|Behavioral|Social Support|Four 5-point Likert scale questions addressing 4 domains of social support: emotional/ informational, tangible, affectionate, and positive social interaction. Score for each item ranges from 1 to 5, and total score ranges from 4 to 20. A higher score means better social support.
15818077|NCT04300998|Behavioral|Brief Test of Attention|assess selective auditory attention.
15818078|NCT04300998|Behavioral|Trail Making Test|Assesses visual scanning, graphomotor speed, and set shifting.
15818079|NCT04300998|Behavioral|Controlled Oral Word Association Test|A timed test of verbal fluency
15818080|NCT04300998|Behavioral|Hopkins Verbal Learning Test-Revised|The HVLT-R is a test of verbal learning and recall. Scores obtained are the total number of words: 1) recalled over three trials; 2)recalled after a delay; 3) correctly recognized.
15818081|NCT04300998|Other|Blood draw|collection of blood tests
15818082|NCT04300985|Drug|Dexmedetomidine|Patients will start receiving dexmedetomidine 15 minutes before general anesthetic induction.
15818083|NCT04300985|Drug|Sham treatment|Patients will start receiving saline solution infusion 15 minutes before general anesthetic induction.
15818084|NCT04300985|Drug|Magnesium Sulfate|Patient will start receiving magnesium infusion (20 mg/kg/h) 15 minutes before general anesthetic induction.
15818085|NCT04300972|Diagnostic Test|Body/weight adaption|contrast media dose is adapted to weight and body type
15818086|NCT04300972|Diagnostic Test|Standard dose|a fixed amount of contrast media is used, independently of weight and body type
15818087|NCT04300959|Drug|Anlotinib Hydrochloride in Combination With PD1 With Gemcitabine Plus(+)Cisplatin|"Gemcitabine:1000mg/m2, days 1 and 8; Cisplatin: 25mg/m2, days 1 and 8； Anlotinib : 10mg po qd, days 1-14; Sintilimab: 200mg IV, day 1；
~1 cycle = 3 weeks."
15818088|NCT04300959|Drug|Gemcitabine Plus(+)Cisplatin|"Gemcitabine:1g/m2, days 1 and 8; Cisplatin: 25mg/m2, days 1 and 8；
~1 cycle = 3 weeks."
15818089|NCT04300946|Device|TMS targeted on the cerebellum|Impact on EEG performance (preparation wave in temporal tasks) of cerebellar stimulation by MSD in healthy subjects. The contrast between the post-stimulation effects of verrum stimulation and placebo stimulation will indicate the magnitude of the effect and will allow us to optimize the type of protocol that may be useful in schizophrenia.
15818090|NCT04300933|Behavioral|Electroencephalogram-based neurofeedback|In this project, SCD participants will receive electroencephalogram-based neurofeedback therapy, once a day, for 5 days. Then, the investigators will compare their memory changes between baseline and post-therapy visits.
15818091|NCT04300920|Drug|N-acetyl cysteine|600 mg N-acetylcysteine (NAC) oral tablets three times daily for 24 months.
15818092|NCT04300920|Drug|Placebo|Matching oral placebo tablet three times daily for 24 months.
15818093|NCT04300907|Device|Provant Infinity Therapy System|Treatment with the Provant Infinity Therapy System, PEMF device
15818094|NCT04300894|Device|Mamma Mia|"Users of the Mamma Mia program progress through the intervention in a sequence of modules.
~Every day that a module should be completed, you will receive a notification with a reminder to access the program. By clicking on the reminder, you can access that particular day's session content. Modules involve a variety of information and activities; for example, there are guided mindfulness practices, information on breastfeeding, instructional videos on how to interpret your baby's cries, and discussions on how to have effective discussions with your partner or healthcare provider about your needs."
15818095|NCT04300894|Other|Mamma Mia Plus|Participants will use the Mamma Mia program, plus receive contact (phone calls or emails or texts) from study staff every few months.
15818096|NCT04300881|Drug|Eplerenone|Following intravitreal ocriplasmin therapy
15818097|NCT04300855|Drug|Sunphenon|The study agent will be administered in divided doses with food, three capsules twice a day (405 mg) for 24 months
15818098|NCT04300855|Drug|Placebo|Matching placebo
15818099|NCT04300842|Device|smart bracelet|to measure the stress, fatigue, and activity.
15818100|NCT04300829|Drug|cicaderma + simple hygiene rules|Cicaderma ointment (2 applications / day: after the radiotherapy session) and in the evening) + simple hygiene rules
15818101|NCT04300829|Other|Simple hygiene rules and a maximum of one topical treatment|Simple hygiene rules according to the site recommandations including eventually a maximum of one topical treatment
15818102|NCT04300816|Behavioral|CBT for Uncertainty Tolerance|"Participants work one-on-one with an interventionist. Treatment sessions focus on understanding the difference between the controllable and uncontrollable aspects of MS, ability to tolerate not knowing exactly what the future will hold, setting personal goals for what accepting what MS will look like, and finding ways to live in conjunction with personal values despite the MS diagnosis."
15818103|NCT04300816|Behavioral|Traditional CBT|Participants work one-on-one with an interventionist. Treatment sessions focus on goal setting, positive activities, identifying and challenging unhelpful thoughts, and bolstering social support.
15818104|NCT04300803|Biological|Tafasitamab, 12 mg/kg. 4 week cycles: weekly (Cycle 1-3) to bi-weekly (Cycle 4 onwards), loading dose Cycle 1, day 4. Cycle 4 onwards day 1, day 15 until disease progression|Expanded Access Program, Non-Interventional Study
15818105|NCT04300790|Drug|Alpelisib|Alpelisib (BYL719): starting dose at 300 mg/QD.; 2 tablets once a day, oral administration, continuously during 28-day cycles until disease progression or unacceptable toxicity.
15818106|NCT04300790|Drug|Metformin|500 mg BID with breakfast and dinner. After 3 days, if no (GI) intolerance, increase to 1000 mg BID with breakfast and dinner. If not tolerated, reduce to prior tolerated dose. Titrate to 1000mg BID over a period of at least 4 additional days
15818107|NCT04300790|Drug|Fulvestrant|"fulvestrant (500 mg IM injections; loading dose 500mg every two weeks for the first month; then every 4 weeks as per standard of care [SoC].
~Patients should be started on metformin and fulvestrant within 7 to 14 days prior to start on alpelisib (D1C1)"
15818108|NCT04300777|Device|SeaSpine Non-Cervical Pedicle Screw Systems|Any patient treated with a SeaSpine Non-Cervical Pedicle Screw System
15818165|NCT04300231|Drug|epidural bupivacaine 0.05%|Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
15818166|NCT04300231|Drug|Liposomal bupivacaine|20 ml
15818167|NCT04300231|Drug|bupivacaine 0.125%|40 mL
15818168|NCT04300231|Drug|bupivacaine 0.5%|60 mL
15818109|NCT04300764|Behavioral|Gamification Intervention|Intervention participants will receive daily text messages to help them set goals, receive feedback and support on their progress towards daily goals, and receive points for daily goals achieved. Each participant will be given a Fitbit watch that will transmit data to the Way to Health study platform. Data will be passively collected during the inpatient stay and for 30 days after hospital discharge.
15818110|NCT04300751|Drug|Alcohol|Active alcohol or placebo, administered orally
15818111|NCT04300751|Drug|Opioid Agonist|Active opioid agonist or placebo, administered orally
15818112|NCT04300738|Device|CCS wit CT Scann measurement|Measurement with 2 devices
15818113|NCT04300725|Other|Video Counseling|Patients in the other study arm receive verbal + video counseling prior to their induction of labor.
15818114|NCT04300712|Behavioral|Questionnaires at the start and end of the school year|Interventions will be proposed to children identified in a worrisome situation. The Strengths and Difficulties. Questionnaire will be used by teachers to score these situations. The recognition process of mental health problem and need continue with responses. Responses are supporting a graduated response process in school and facilitating external support when needed (mental health services, community supports). Early intervention is one of all responses, which involve caregivers. Responses to worrisome situations aim to improve schooling conditions, to acknowledge mental health problems or condition and the health services need for children. To evaluate the intervention, the impact supplement of SDQ and the follow-up questions will be used by the teachers and the parents of children who benefit of the intervention. The interventions will be experimented during year 2020-21. Children might benefit of them from several weeks to one year, according to their need.
15818115|NCT04300699|Other|Functional Geriatric Assessment|A series of 8 self-completed questionnaires for the identification of functional deficits which will be addressed via algorithm-guided interventions and assessments.
15818116|NCT04300686|Biological|Tocilizumab|"The tocilizumab group is prescribed with tocilizumab (8mg/kg.qm.ivgtt.) for 24 weeks, and the disease activity is monitored in the follow-up (primary endpoint).
~After 24 weeks of treatment, if the disease is alleviated (remission), then the usage of tocilizumab is maintained for another 24 weeks, otherwise (resistant), patients would be given adalimumab (40mg.bim.IH.) for 24 weeks instead."
15818117|NCT04300686|Biological|Adalimumab|"The adalimumab group is prescribed with adalimumab (40mg.bim.IH) for 24 weeks, and the disease activity is monitored in the follow-up (primary endpoint).
~After 24 weeks of treatment, if the disease is alleviated (remission), then the usage of adalimumab would be maintained for another 24 weeks, otherwise (resistant), patients would be given tocilizumab (8mg/kg.qm.ivgtt.) for 24 weeks instead."
15818118|NCT04300673|Procedure|Radio guided surgery (RGS) using Indium-labelled PSMA|Approximately 24hours prior to surgery (PLND) patients receive a radiolabelled PSMA-tracer. During surgery, urologists will use a gamma-probe to detect PSMA-postitive tumour depostitions in pelvic lymph nodes.
15818119|NCT04300660|Other|neuropathic pain after thoracic surgery|analysis of perioperative factors implicated in the onset of postoperative pain after chest surgery and the incidence of neuropathic pain
15818120|NCT04300647|Drug|Tiragolumab|Tiragolumab at a fixed dose of 600 milligrams (mg) will be administered by intravenous (IV) infusion every 3 weeks (Q3W) on Day 1 of each 21-day cycle.
15818121|NCT04300647|Drug|Atezolizumab|Atezolizumab at a fixed dose of 1200 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
15818122|NCT04300621|Drug|OTF 1|Participants will receive (S)-ketamine administered sublingually through OTF 1.
15818123|NCT04300621|Drug|OTF 2|Participants will receive (S)-ketamine administered sublingually through OTF 2.
15818124|NCT04300621|Drug|OTF 3|Participants will receive (S)-ketamine administered sublingually through OTF 3.
15818125|NCT04300621|Drug|OTF 4|Participants will receive (S)-ketamine administered sublingually through OTF 4.
15818126|NCT04300595|Procedure|Combination of General anesthesia and local anesthesia in dacryocystorhinostomy surgery|"all patients were assigned randomly to receive either general anesthesia with intravenous opioids and local infiltration of saline (Group G) or general anesthesia with intravenous saline and local infiltration of a mixture of lidocaine/epinephrine (Group L).
~In both groups, general anesthesia was induced with 2 mg/kg propofol and tracheal intubation was facilitated by 0.1 mg/kg cisatracurium. All patients underwent mechanical ventilation with 100% oxygen. Anesthesia was maintained with isoflurane, and muscle relaxation was provided by an injection of cisatracurium 0.02 mg/kg every 20 minutes."
15818127|NCT04300582|Procedure|Cardiac catheterization standard strategy|Cardiac catheterization by forearm approach 3 to 24 hours after thrombolytic completion in STEMI patients
15818128|NCT04300582|Procedure|Cardiac catheterization fast strategy|Cardiac catheterization by forearm approach within 3 hours after thrombolytic completion in STEMI patients
15818129|NCT04300569|Other|Non-interventional|No intervention will be administered.
15818131|NCT04300517|Drug|Three sachet of protein supplement to be mixed in with water used daily|Three sachet of protein supplement to be mixed in with water used daily
15818133|NCT04300491|Other|Suspension walking training|Physiotherapy session, objective wlaking with body weight support using a specific device
15818134|NCT04300478|Behavioral|REx Condition First|REx condition: Participants will complete a whole-body REx workout consisting of 1-set to failure (e.g. RPE of 9-10 on 10-point scale on final reps) on 12 exercises in the Exercise Research Laboratory (located in the CTRC), with a 3-minute rest between exercises. Participants will complete the following exercises: leg press; leg extension; leg curl; hip abduction; hip adduction; chest press; overhead press; seated row; overheard pulldowns and assisted triceps dips on Cybex resistance equipment; barbell calf raises on a Smith machine; and dumbbell biceps curls. Resistance for the REx trial will be determined based on the exercise familiarization session. Specifically, we will target a resistance level needed for each participant to complete ~12-15 repetitions per exercise, using proper form, with an RPE of 9-10 on a 10-point scale on final reps. This protocol eliminates the need for max testing in order to set an exercise protocol off of a specific intensity based on % of 1RM.
15818135|NCT04300478|Behavioral|Sedentary Control Condition First|Sedentary control condition: Participants will sit quietly in a seated position for the entire duration of this condition.
15818169|NCT04300231|Drug|/hydromorphone 0.05mg/ml|Mix of epidural bupivacaine 0.05% and hydromorphone 0.05mg/ml will be given using PCEA.
15818170|NCT04300231|Drug|injectable saline|40 mL
15818136|NCT04300465|Behavioral|10 week MySlainte Program|"The intervention consists of a 10 week community based lifestyle intervention program. It consists of a weekly 1 hour exercise class, a weekly 1 hour health promotion workshop as well as individualised goal setting, exercise prescription and optimisation of cardioprotective medications.
~This program is delivered by a multi-disciplinary team; including a physiotherapist, occupational therapist, dietitian, clinical nurse specialist and physician. It will be delivered through a registered Irish charity, Croí."
15818137|NCT04300452|Drug|Carbetocin|Administration of Carbetocin after placental detachment
15818138|NCT04300452|Drug|Ergometrine Maleate|Administration of ergometrin after placental detachment
15818139|NCT04300439|Device|knee total arthroplasty with two types of ancillaries|"-For the Arm A, the surgical procedure of knee total arthroplasty will be done with metallic reusable ancillary.
~For the Arm B, the surgical procedure of knee total arthroplasty will be done with Efficiency single use ancillary."
15818140|NCT04300426|Drug|"ACHIM as solute (10^9 intestinal microbes/ml)"|Culture of intesinal microbiota originally derived from a healthy subject are administered to a person with presumed dysbiotic intestinal symptoms with an objective to treat these symptoms.
15818141|NCT04300413|Other|High-Intensity Rehabilitation plus Mobility (HeRo)|Progressive, high-intensity strengthening and functional intervention coupled with structured mobility based in principals of behavioral economics.
15818142|NCT04300400|Other|Delphi questionnaire|Statements on OAB topics, rated along their level of appropriateness on a scale from 1 to 9. Multiple rounds are organised to reach consensus on a topic.
15818143|NCT04300387|Behavioral|multidisciplinary care|multidisciplinary CKD care involving case management nurse, dietitian, social worker, pharmacists.
15818144|NCT04300374|Other|The Paediatric Anaesthesia Emergence Delirium scale assesment which was recorded postoperatively|routine remifentanil infusion during general anesthesia
15818145|NCT04300361|Genetic|Sequencing of DPYD gene|The DPYD gene of non-Western patients will be sequenced to identify DPYD variants that are possibly associated with an increased risk of developing severe fluoropyrimidine-related toxicity.
15818146|NCT04300348|Device|Heel2Toe|Heel to Toe (Heel2Toe) is a device that clips on the shoe and provides an instant auditory feedback (a beep) for each correct step characterized by putting the heel first and it provides data on gait parameters
15818147|NCT04300348|Other|No-feedback control group|The control group will follow the same protocol as the Heel2Toe group but the device will not be in feedback mode just in data acquisition mode.
15818148|NCT04300335|Other|Individual Exercise|Supervised body weight & resistance band resistance exercises in a one-on-one personal training setting plus home based aerobic exercise
15818149|NCT04300335|Other|Group Exercise|Supervised body weight & resistance band resistance exercises in a Group setting plus home based aerobic exercise
15818150|NCT04300322|Device|Cervical pessary|Arabin (cervical pessary) will be inserted at 16-22 weeks and removed at 37 weeks of pregnancy or in case of premature rupture of membranes, signs of preterm labour or patient severe discomfort
15818151|NCT04300322|Drug|Vaginal Progesterone|Vaginal progesterone (Cyclogest 200 mg) once a day will be used, from 16-22 to 37 weeks of pregnancy or in case of premature rupture of membranes, signs of preterm labour or patient severe discomfort.
15818152|NCT04300309|Drug|artemether:lumefantrine (2.5 mg:30 mg)|artemether:lumefantrine (2.5 mg:30 mg)
15818159|NCT04300283|Behavioral|Hypnosis|See previous description
15818160|NCT04300270|Device|Smartphone PPG recordings|Smartphone camera PPG recordings using a novel software application.
15818161|NCT04300270|Device|Smartphone ECG|Smartphone connected one-lead ECG recordings.
15818171|NCT04300218|Behavioral|internet-delivered cognitive-behavioral therapy for insomnia (iCBT-I)|"The 2-month intervention consists of educational material divided into 8 modules, which provide the rationale for the CBT-I interventions: sleep restriction; stimulus control; cognitive techniques; relaxation techniques. Information is presented in 10-minute videolectures.
~The program includes a sleep diary to insert bedtime and waketime, sleep latency, total sleep time, night awakenings.
~All material will be delivered through the internet program and expected to be elaborated by the patient but with the opportunity to contact a specialist via the feedback form (guidance on request) in a secured environment if they face difficulties or possible negative effects of the intervention. The content of the program is based on an already established internet-based self-help program against insomnia that was already tested in a previous study."
15818172|NCT04300218|Other|Care as usual (CAU)|Intervention includes all variety of therapy methods that can be prescribed by medical doctors (MD): pharmacotherapy, behavioral recommendations, face-to-face psychotherapy. Prescriptions may be made during the first visit to MD, or at any point in the study on a next doctor visit, or during visits to the doctors of other medical centers. All concurrently applied treatments will be assessed repeatedly by self-report
15818173|NCT04300205|Device|High intensity LED light device|Participant wounds are treated with LED light device for 10 minutes, 4 times over the course of 2 months
15818174|NCT04300205|Device|Sham LED light device|Participants have the light treatment moved off their wound after masking
15818175|NCT04300192|Biological|Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Combined with Inactivated Poliomyelitis Vaccine|Pharmaceutical form:Suspension for injection - Route of administration: Intramuscular
15818176|NCT04300166|Device|Telemedicine & Humidification|Wireless control of CPAP usage, adherence, leakage and humidifier usage
15818177|NCT04300153|Procedure|ESP Block|At the end of the skin closure, patients will be positioned in lateral decubitis with the involved site lying superiorly. A convex ultrasound probe will be placed over the transverse process of T12 vertebra in longitudinal axis and an 80- mm 21-gauge needle will be inserted in the plane view under aseptic conditions. A unilateral ESP block will be performed with 30 ml 0.25% bupivacaine into the interfascial plane between erector spinae muscle and T12 transverse process
15818178|NCT04300153|Other|Global Quality of Recovery-15 score|Global Quality of Recovery-15 score (QoR-15) will be recorded prior to the surgery and at the postoperative 24th hour.
15818179|NCT04300153|Other|Standard Pain Followup and Monitorization|Numeric Rating Scale score will be recorded at the 1.-2.-4.-6.-8.-12.-24.hours. If Numerical Rating Scale score will be equal to or over 4, iv dexketoprofen 50 mg will be applied as rescue analgesic. Numerical Rating Scale scores, the rescue analgesic need and the time for first mobilization of the patient will be recorded and kept in a statistical evaluation.
15818180|NCT04300140|Drug|AVB-S6-500|AVB-S6-500 is experimental drug
15818181|NCT04300140|Drug|Cabozantinib (Cabo)|Cabo is active comparator
15818182|NCT04300127|Drug|Pioglitazone 30 mg|Patients will received 30 mg of Pioglitazone once a day for 8 weeks
15818183|NCT04300114|Drug|Fluzoparib|Fluzoparib capsules po. 150 mg twice daily
15818184|NCT04300114|Drug|Placebo|Placebo capsules po. twice daily
15818185|NCT04300101|Other|molecular characterization|"immunohistochemical determinations: Cell of Origin (COO) (according with Hans algorithm), evaluation of Cluster of Differentiation (CD) (CD20, CD5, CD10), Bcl6, Bcl2 (cut off>50%), MUM1/IRF4, c-myc (cut off>40%) and Ki67, FISH for c-myc and if rearranged for Bcl2 e Bcl6.
~mRNA expression by Nanostring Single cell analysis Immune checkpoint expression Proteomic analysis Metabolic analysis"
15818186|NCT04300075|Device|CUSABT|Subject receives use of the CUSA Clarity Bone Tip product during cranial skull base bone removal surgery
15818187|NCT04300062|Procedure|Rebiopsy|Biopsy will be carry out with flexible bronchoscopy as usual practice under local anesthesia: under endobronchial ultrasound, punction under CT scan or ultrasonography, percutaneous pleural puncturing.
15818188|NCT04300049|Drug|Glucagon Infusion|Study participants will receive glucagon infusion (6ug/kg/min for 12 hours) 12 hours.
15818189|NCT04300049|Other|Saline|Study participants will receive saline infusion for 12 hours.
15818190|NCT04300036|Dietary Supplement|longan syrup|Subjects will take 15 ml of longan syrup once a day for 3 months
15818191|NCT04300036|Dietary Supplement|Placebo syrup|Subjects will take 15 ml of placebo syrup once a day for 3 months
15818192|NCT04300023|Behavioral|Social Cycling Group|engaged with a research staff member for 30 minutes of cycling
15818193|NCT04300023|Behavioral|Solo Cycling Group|Exercise without a partner for a target period of time and intensity.
15818194|NCT04300010|Drug|5% Topical Benzoyl Peroxide Gel|Gel treatment used to treat acne
15818195|NCT04300010|Device|Blue Light Therapy|Blue light therapy treatment for acne
15818196|NCT04299997|Other|Assessment of the accuracy of the PI-RADS v2.1 score for predicting the presence of ISUP ≥2 prostate cancer at subsequent biopsy in the dataset of the 163 MRIs for 20 different readers.|"Ass of targeted suspect lesions
~On each mpMRI,radiologist will contour lesions that were targeted at subsequent biopsy based on reports. Contours will be disclosed to readers who will assess,for each lesion:
~Likert score(gut feelingie subjective ass of the likelihood that lesion is clinically significant prostate cancer(5-level scale))
~PI-RADSv2, PI-RADSv2.1 score(by strictly applying the published PI-RADS criteria)
~EPE score(ie the likelihood of extraprostatic extension;5-level subjective scale without predefined criteria)
~Max diameter
~Def of add suspect lesions Readers could define suspectadditional targets(AT);for each AT,they will provide the same criteria. It is expected that, for these suspect AT,at least one score is≥3
~Ass of lobes Scores of prostate lobes will be automatically calculated based on 2 previous steps of reading. However,in lobes with no suspect lesion,readers could define whether same criteria are1or2,in peripheral zone and transition zone"
15818197|NCT04299984|Procedure|Open Conversion after EVAR|"See Open Conversions group description."
15818198|NCT04299984|Procedure|SemiConversion after EVAR|"See SemiConversions group description."
15818199|NCT04299971|Drug|Methotrexate Tablets|"The methotrexate group is prescribed with methotrexate Tablets for 24 weeks, and the disease activity is monitored in the follow-up (primary endpoint).
~After 24 weeks of treatment, if the disease is alleviated, then the usage of methotrexate is maintained for another 24 weeks, otherwise (resistant), patients would be given tofacitinib (5.0mg.bid.p.o.) for 24 weeks instead."
15818319|NCT04298957|Procedure|Cone biopsy|Cone biopsy if transformation Zone (TZ) 2 or TZ 3
15818200|NCT04299971|Drug|Tofacitinib tablet|"The tofacitinib group is prescribed with tofacitinib tablets for 24 weeks, and the disease activity is monitored in the follow-up (primary endpoint).
~After 24 weeks of treatment, if the disease is alleviated, then the usage of tofacitinib is maintained for another 24 weeks, otherwise (resistant), patients would be given methotrexate (15.0mg.qw.p.o.) for 24 weeks instead."
15818201|NCT04299958|Other|Patient diary|In the first visit they will be examined by a neurologist with experience in headache disorders and NH diagnosis will be reviewed. Patients will be invited to participate into the study and they will provide and sign informed consent form. They will be instructed and trained to complete the prospective headache diary during 14 days. A follow up visit will be done within 15 to 30 days to review the data and analyze possible sources of bias.
15818202|NCT04299945|Dietary Supplement|concentrated beetroot juice (400mg of nitrate per serving)|Dietary nitrate supplementation includes consumption of two beverages daily for 7 consecutive days.
15818203|NCT04299945|Dietary Supplement|concentrated beetroot juice (trace amounts of nitrate per serving)|Dietary placebo supplementation includes consumption of two beverages daily for 7 consecutive days.
15818204|NCT04299932|Procedure|Electroacupuncture|BL33 is located in the third posterior sacral foramen; BL35, 0.5 cun (≈10mm) lateral to the extremity of the coccyx; and SP6 posterior to the medial border of the tibia, 3 cun superior to the prominence of the medial malleolus. BL33 will be inserted by needles of 0.30×75mm size at the angle of 45°, inward and downward, till the depth of 60-70mm. BL35 will be inserted by needles of 0.30×75mm size, slightly outward and upward, till the depth of 60-70mm. SP6 will be inserted by needles of 0.30×40mm till the depth of 25-30mm. All the needles will be lifted, thrust and twisted evenly for three times, right after insertion, to induce the sensation of deqi. Electronic acupuncture apparatus (Yingdi KWD 808 I electro pulse acupuncture therapeutic apparatus, Changzhou Yingdi Electronic Medical Device Co., Ltd) will be connected to the three pairs of needles transversally, with continuous wave of 20 Hertz (Hz), electric current of 2-6.5 milliampere (mA) for BL33 and BL35, and 1mA-3.5mA for SP6.
15818205|NCT04299932|Procedure|Sham electroacupuncture|Sham BL33 is in the area of 1 cun (≈20mm) horizontally outside BL33; sham BL35, 1 cun (≈20mm) horizontally outside BL35; Sham SP6, in the middle of SP6 and tendons. The three pairs of acupoints will be inserted by needles of 0.30×40mm size to a depth of 2-3mm till the needles can stand still. No manipulations will be conducted, and the sensation of deqi will not be induced. Electronic acupuncture apparatus (Yingdi KWD 808 I electro pulse acupuncture therapeutic apparatus, Changzhou Yingdi Electronic Medical Device Co., Ltd) will be connected to the three pairs of needles transversally, with continuous wave of 20Hz and minimal electric current (ideally at a degree which participant can just percept). In about 30 seconds, the electric current will be turned down, leaving the indicator light and ticking sound on.
15818206|NCT04299919|Procedure|Minimally invasive treatment|All hepatocellular carcinoma (HCC) patients received minimally invasive treatment, including transcatheter arterial chemoembolization (TACE), radiofrequency ablation (RFA) or combined.
15818207|NCT04299919|Procedure|Hepatectomy|All hepatocellular carcinoma (HCC) patients received hepatectomy.
15818208|NCT04299906|Device|Solaris Vascular Stent Graft|Solaris Vascular Stent Graft for treatment of Iliac Lesions
15818209|NCT04299893|Drug|Ozone|Ozone Group: Standard treatment + Ozone therapy (O3/O2) by rectal insufflation. O3/O2 concentration progressively increased from 10 to 30 μg/ml; 40 sessions in 16 weeks.
15818210|NCT04299893|Drug|Oxygen|Control Group: Standard treatment + Oxygen (O2) by rectal insufflation. O3/O2 concentration = 0 μg/ml (only O2); 40 sessions in 16 weeks.
15818211|NCT04299880|Drug|Napabucasin|Oral
15818212|NCT04299880|Drug|Nab-paclitaxel|Intravenous
15818213|NCT04299880|Drug|Gemcitabine|Intravenous
15818214|NCT04299880|Drug|Nivolumab|Intravenous
15818215|NCT04299880|Drug|Paclitaxel|Intravenous
15818216|NCT04299880|Drug|Irinotecan|Intravenous
15818217|NCT04299880|Drug|Leucovorin|Intravenous
15818218|NCT04299880|Drug|5Fluorouracil|Intravenous
15818219|NCT04299880|Drug|Bevacizumab|Intravenous
15818220|NCT04299867|Procedure|Bowel Surgery with Metronidazole|"Metronidazole will be given per standard of care prior to incision. Intraoperative plasma samples will be obtained from pre-existing vascular access catheters at end of bolus, 30, 60, 90 minutes, at time of intestinal excision(s), and at the end of the case in ethylenediaminetetraacetic acid microcontainers, exceeding no more than approximately 5 mL total.
~At the time of intestinal excision, the surgeon will cut at least 500 mg of intestine from the specimen, ensuring all layers of bowel are included. If more than one intestinal sample is taken during the surgery, such as in the case of multiple strictures removed, each sample will be obtained and labeled appropriately."
15818221|NCT04299854|Drug|Dinoprostone 10mg|Vaginal delivery system containing 10mg of dinoprostone placed at the bottom of the vagina
15818222|NCT04299854|Device|single balloon Foley catheter|A single balloon Foley catheter is being inserted on transcervical and inflated above the internal cervical os
15818223|NCT04299828|Other|Discarded blood samples|Will utilize the discarded blood from routine clinical blood samples to evaluate the role of immune cells in coagulopathy.
15818224|NCT04299815|Drug|Oral Sodium Lactate|25 grams of D/L lactate dissolved in 300mL water.
15818225|NCT04299815|Drug|Intravenous sodium lactate|intravenous sodium lactate + oral sodium-chlorid solution
15818226|NCT04299802|Drug|Leukocyte-Rich Platelet-Rich Plasma|LR-PRP will be a concentration of PRP with the addition of leukocytes. Studies have shown that LR-PRP is more effective in treating tendinopathy than leukocyte-poor platelet-rich plasma.
15818227|NCT04299802|Procedure|Percutaneous Ultrasonic Tenotomy|Discussed in Percutaneous Ultrasonic Tenotomy Arm section
15818228|NCT04299789|Other|Validating the Military Service Identification Tool|This study seeks to validate the Military Service Identification Tool in its ability to accurately determine military service status.
15818229|NCT04299776|Device|CirQPOD|CirQPOD is connected between the wye piece on ventilator/anesthesia machine tubing and the patient's airway and generates negative intrathoracic pressure during the expiratory phase of ventilation which has been shown to improve blood flow.
15818230|NCT04299776|Device|Standard airway management|Standard airway management during surgery (PEEP of +5 cmH2O)
15818320|NCT04298944|Diagnostic Test|Cardiovascular Assessments|Participants will undergo the following cardiovascular assessments: 24-hour blood pressure monitoring, arterial stiffness measurements, endothelial function measurements.
15818231|NCT04299763|Dietary Supplement|Oat Beta-glucan as a Supplement in Type 2 Diabetics|44 subjects were randomized into two groups, placebo (PL) and β-glucan (BG). Each person received a package with a supplement sufficient for 12 weeks, adding 5 g of supplement to breakfast, which could contain beta-glucan or not. Blood and stool samples were requested at the beginning and at the end of the intervention.
15818232|NCT04299750|Procedure|Tooth extraction and Alveolar ridge preservation|Tooth extraction and alveolar ridge preservation with deproteinized bovine bone mineral and a collagen matrix seal
15818233|NCT04299750|Procedure|Tooth extraction|Tooth extraction and socket natural healing
15818234|NCT04299737|Other|Treatment Bundle (as defined below)|Patient decolonization within one hour of incision, improved environmental cleaning (frequency and quality, including but not limited to targeted use of no touch disinfection with UV-C treatment), provider hand hygiene leveraging proximity, improved catheter disinfection, and surveillance optimization.
15818235|NCT04299724|Biological|Pathogen-specific aAPC|The subjects will receive three injections of 5x10^6 each Covid-19/aAPC vaccine via subcutaneous injections.
15818236|NCT04299711|Other|Exposed to the novel coronavirus disease 2019|Exposed to the novel coronavirus disease 2019
15818237|NCT04299698|Behavioral|lifestyle|Participants who desire to control body fat mass chose the one of lifestyle modification on their diet or exercise.
15818238|NCT04299685|Other|Interview|Qualitative family interviews of 20 family units, or more until data saturation, of at least one parent and one adolescent (aged 10-19 year old) will be conducted based on deductive thematic approach. Each interview will last for about an hour, be conducted in Cantonese, and audio-taped for transcription in verbatim in Chinese.
15818239|NCT04299672|Procedure|Postural reconstruction|Interventions are described in group descriptions
15818240|NCT04299659|Diagnostic Test|Landolt C entry method|Four different methods for entering the Landolt C gap position are compared
15818241|NCT04299646|Radiation|Steretactic radiotherapy|Steretactic radiotherapy
15818242|NCT04299646|Drug|Pursuit of ongoing systemic treatment|Pursuit of ongoing systemic treatment
15818243|NCT04299633|Drug|Vadadustat|2 x 150 mg oral tablets
15818244|NCT04299633|Drug|Sevelamer carbonate|2 x 800 mg oral tablets
15818245|NCT04299633|Drug|Calcium acetate|2 x 667 mg oral gelcaps
15818246|NCT04299633|Drug|Auryxia®|2 x 1 gram tablets (210 mg ferric iron equivalent to 1000 mg ferric citrate)
15818250|NCT04299607|Diagnostic Test|DPP Fever Panel II assay and DPP Micro Readers|Detection of common causes of acute febrile illnesses in Asia
15818251|NCT04299594|Other|Questionnaire|For each subject recruited, will be collected for the study a questionnaire looking for a history of low energy fracture, and the origins of the patient (or relatives), as well as medical history, lifestyle (alcohol and tobacco consumption), weight and height. This data will be used for the secondary outcomes.
15818252|NCT04299581|Drug|Camrelizumab|a PD-1 immune check inhibitor
15818253|NCT04299581|Combination Product|US/CT-guided Percutaneous Cryoablation|Cryoablation will be performed with a two-cycle freeze-thaw phase protocol; US or non-contrast CT images will be obtained to visualize the evolving ablation zone
15818254|NCT04299568|Device|Anti gravity treadmill training|Lower Body Positive Pressure (LBPP) treadmill training for 15 minutes
15818255|NCT04299568|Procedure|Physical Therapy|Heat Therapy in combination with Electro-therapy for 10 minutes, followed by tibio-femoral and patello-femoral joint mobilization
15818256|NCT04299542|Procedure|Percutaneous lung biopsy using conventional MDCT|Conventional CT biopsy will be performed using a 64 slice CT scanner. A preliminary plain CT is acquired covering the entire target lesion with a skin marker, and the interventional radiologist would decide on the skin puncture site and the needle pathway. A post-procedural CT scan will be made to detect pneumothorax or pulmonary haemorrhage. All images will be archived in the picture achieving and communication system (PACS).
15818257|NCT04299542|Procedure|Percutaneous lung biopsy CBCT|CBCT guided biopsy will be performed in the angiography suite. A preliminary CBCT (DynaCT) is acquired covering the entire target lesion is first performed. Image data will be displayed and processed using Syngo iGuide system. A potential needle trajectory will be drawn from skin to lesion. Integration of the cross-sectional images and real time fluoroscopy will result in three system positions: one bull's eye view and two progression views. During fluoroscopy, the planned needle trajectory and target will be overlaid on the real time fluoroscopy image. After the needle reaches the target, another CBCT will be performed to confirm needle position. Biopsy using coaxial system and post-procedural CT scans will be performed in similar fashion as the conventional CT group.
15818258|NCT04299529|Diagnostic Test|In-vitro urinary diagnostic test|Urinary proteomic profiling (UPP) using established multidimensional urinary markers for progression to CKD (CKD273), left ventricular dysfunction (HF1 and HF2) and coronary heart disease (CAD238 and ACSP75) - in-vitro test certified in Germany and by extension in the EU (DE/CA09/0829/IVD/001, DE/CA09/0829/IVD/005).
15818259|NCT04299516|Procedure|Two-team simultaneous bilateral total knee arthroplasty|Bilateral total knee arthroplasty can be performed in three different ways: single-stage, two-team simultaneous bilateral total knee arthroplasty; single-stage, one-surgeon, and two-stage bilateral total knee arthroplasty. Two surgeons will operate simultaneously on one side for two-team SBA.
15818260|NCT04299516|Procedure|Single-team simultaneous bilateral total knee arthroplasty|One surgeon will operate sequentially on both sides for one-surgeon SBA
15818261|NCT04299503|Drug|Crisaborole Topical Ointment|For every 10% of scalp affected, approximately ½ finger tip of study drug will be needed to cover the area with a thin layer. After the first application at baseline, the tubes will be weighed to determine the dose needed to cover the affected area. This will be the subject's target dose throughout the study
15818262|NCT04299503|Drug|Placebo Topical Ointment|For every 10% of scalp affected, approximately ½ finger tip of study drug will be needed to cover the area with a thin layer. After the first application at baseline, the tubes will be weighed to determine the dose needed to cover the affected area. This will be the subject's target dose throughout the study
15818321|NCT04298944|Diagnostic Test|Actigraphy|Participants will wear an actigraph device for 7 days to measure participant's activity and sleep
15818263|NCT04299490|Behavioral|Sleep Fragmentation|Subjects are provided an 8-hour sleep opportunity. Two speakers are placed 12 inches from the head of the bed and four remote-activated mechanical vibrators are placed underneath the mattress. EEG microarousals (>3 s), as defined according to standard criteria, are elicited at a frequency of 30 or more events per hour.
15818264|NCT04299490|Drug|Within-Subject test of blinded study medication (stimulant, benzodiazepine, opioid, cannabinoid, over-the-counter pain medication, or placebo)|On the third day of the in-patient visit participants will undergo multiple injections of study medication or placebo. This is a double-blind within-subject Phase II trial. As such, study medications must remain blinded. Participants may receive a medication from one or more of the following categories: prescription stimulants, prescription benzodiazepines, prescription opioids, prescription cannabinoids, over-the-counter pain medications, or placebo (saline).
15818265|NCT04299490|Behavioral|Sleep Continuity Disruption|An 8-hour sleep opportunity period starting from lights out is divided into eight, one-hour intervals. One of the intervals is randomly determined to be a 60 minute forced awakening, during which no sleep is permitted. Each of the remaining seven, 60-minute intervals are subdivided into tertiles (20 min. blocks). A 20-min forced awakening (FA) is randomly scheduled to occur in either the 1st, 2nd, or 3rd tertile of each hour. During FAs, staff keep subjects awake, either by voice or gentle shaking.
15818266|NCT04299490|Behavioral|Undisturbed Sleep|Subjects sleep normally for an 8 hour period.
15818267|NCT04299477|Procedure|non-surgical periodontal treatment|supra- and subgingival scaling, and root planning
15818268|NCT04299464|Drug|Placebo|Participants will receive oral placebo for approximately 12 weeks.
15818269|NCT04299464|Drug|RO7017773|Participants will receive oral RO7017773 for approximately 12 weeks.
15818270|NCT04299451|Other|Open dialogue about CAM|1-hour dialogue about CAM with a nurse specialist as an integrated part of conventional oncology care
15818271|NCT04299438|Drug|Propranolol Hydrochloride|2mg/mL vials
15818272|NCT04299438|Other|Saline|0.9% saline in vials matching the vials of the active drug
15818273|NCT04299425|Device|NIRAF Detection Technology|"Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device).
~After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio > 1.2 is interpreted by device as the suspect tissue being positive for parathyroid."
15818274|NCT04299412|Device|DPP Fever Panel II assay|Multiplex lateral flow immunoassay (DPP® Fever Panel II Assay) that is able to detect (i) antigens produced by Dengue, Zika, Chikungunya, Malaria and Burkholderia and (ii) IgM directed against Dengue, Zika, Chikungunya, Leptospira, Rickettsia typhi and Orientia tsutsugamushi. The assay comes with a reader that provides results interpretation to the operator in a few seconds
15818275|NCT04299373|Drug|Alcohol: Oral administration|Patients who plan to undergo bariatric surgery will consume a controlled dose of alcohol orally.
15818276|NCT04299373|Drug|Alcohol: Intravenous administration|Patients who plan to undergo bariatric surgery will be infused with alcohol intravenously.
15818277|NCT04299360|Device|Cardiac Resynchronization Therapy device programming|Implanted CRT-D devices settings will be programmed based on the best acute hemodynamic response assessed non-invasively
15818278|NCT04299334|Procedure|adjustable neochordae Technique|"Classic ring annuloplasty will be done using Carpentier or physio ring, then neochordal placement will be done using the looping technique. The length of the chordae is adjusted to achieve the optimal length.
~In this study, Surgeons use relatively short loops because of the augmentation of the length with extra loops suspended with Gortex. Placement of at least 8-12 chordae of the corresponding heads of the papillary muscle tip to achieve proper management of the prolapse and longevity of the repair."
15818279|NCT04299308|Behavioral|Aerobic Exercise|Participants will exercise for 15 minutes based on heart rate range. The study team will employ a stationary bike to maintain control over workload
15818280|NCT04299295|Device|YVOIRE Y-Solution 360|Hyaluronic acid dermal filler
15818281|NCT04299295|Device|Juvéderm VOLBELLA|Hyaluronic acid dermal filler
15818282|NCT04299282|Device|CanGaroo|CIED ECM envelope
15818283|NCT04299269|Other|Questionnaire|Questionnaire including questions about Quality of life, symptoms and general informations
15818284|NCT04299256|Behavioral|Benson relaxation combined with music therapy|In the first interview, the patient information delivered a training booklet explaining the definition, purpose, benefits and application techniques of BRT and music therapy to the patients in the intervention group. After patients reviewed the details in the training booklet, a weekly schedule was planned for each patient based on their hemodialysis days. For the initiation of the intervention, patients were invited to the hemodialysis unit at the hospital 45 min prior to their hemodialysis sessions. All the participants wore black eye patches to provide a dim environment and to focus better on their breath and the music piece. Then, the patients information opened the music piece and gave Benson Relaxation Technique comments in a slightly lower voice. Each session lasted for 20 min, and the music piece was switched off as Benson Relaxation Technique ended. The music piece used in the study was Daniel Kobelco's non-verbal classical song.
15818285|NCT04299243|Device|Contact Lenses|Contact lenses for vision correction
15818286|NCT04299230|Device|Cortium C3|
15818287|NCT04299217|Dietary Supplement|Zynamite®|Zynamite® is a novel mango (Mangifera indica) leaf extract standardized to contain 60% of the polyphenol mangiferin. Zynamite® is classified as a food or food supplement and is available for purchase within the EU. Zynamite® is not associated with any significant deleterious side effects.
15818288|NCT04299217|Other|Placebo|Placebo comparator (carrier)
15818289|NCT04299204|Procedure|Percutaneous nephrolitotomy|Pediatric PCNL
15818322|NCT04298944|Diagnostic Test|Laboratory assessments|Participants will provide blood and urine samples for laboratory assessments.
15818323|NCT04298944|Behavioral|Emotional/ Behavioural assessments|Emotional /Behavioral well being will be determined by questionnaires: Pediatrics Adverse Childhood Experiences Questionnaire (ACEs Q), Childrens Emotion Management Scale Questionnaire (CEMS) and Behavior Assessment System for Children (BASC)
15818290|NCT04299191|Drug|2-OHOA|"Once a patient is allocated a dose of 2-OHOA, they will receive the same dose on a daily basis in treatment cycles of 21 days (3 weeks), which may be repeated without therapy interruption until a criterion for discontinuation (clinical or radiological progression of disease, clinically unacceptable toxicity, or another general criterion) is met.
~The starting dose will be 2.8 g/m2 twice daily. If tolerated, doses will be escalated to 3.5 g/m2 twice daily and then to a third dose level of 4.2 g/m2 twice daily. These dose levels correspond to 80%, 100%, and 120% of the maximum tolerated dose of 2-OHOA in adult patients when adjusted for body surface area. A total of 3 dose cohorts are anticipated for the dose escalation phase of the study, with up to 6 patients enrolled at each dose level according to a standard 3+3 design. During each dose cohort, at least 1 week must elapse between the first and subsequent patients receiving treatment with 2-OHOA."
15818291|NCT04299178|Device|X-PLO2R POC|Portable Oxygen Concentrator (POC)
15818292|NCT04299165|Device|Kaia COPD Application|The study intervention consists of training sessions conducted daily by the patient via the COPD-App.
15818293|NCT04299165|Other|Usual Care|The control group will also be an active control as participants receive a leaflet to convey an active lifestyle and a list of exercises to do at home.
15818294|NCT04299152|Combination Product|Stem Cell Educator-Treated Mononuclear Cells Apheresis|"SCE therapy circulates a patient's blood through a blood cell separator, briefly cocultures the patient's immune cells with adherent CB-SC in vitro, and returns the educated autologous immune cells to the patient's circulation."
15818295|NCT04299139|Other|chiropractic treatment|There is no intervention. Data that has been collected during the time a patient was attending a chiropractor. This data will be evaluated
15818296|NCT04299126|Device|high absorption pad for blood and pus|High absorption pad for blood and pus will be covered on half of split-thickness skin graft donor site wound until the wound has healed.
15818297|NCT04299126|Device|commercial wound dressing|Commercial wound dressing will be covered on half of split-thickness skin graft donor site wound until the wound has healed.
15818298|NCT04299113|Drug|Vinorelbine|Given IV
15818299|NCT04299113|Drug|Mocetinostat|Given PO
15818300|NCT04299100|Behavioral|Sleep Health Program for Participants with No/Mild Sleep Apnea|Participants randomized to the Sleep Health Program will receive the Self-Management for Sleep Care videos and digital materials.
15818301|NCT04299100|Behavioral|Sleep Health Program for Participants with Moderate/Severe Sleep Apnea|Participants randomized to the Sleep Health Program with suspected moderate/severe sleep apnea will receive the Self-Management for Sleep Care videos and digital materials, and be recommended for referral to a sleep clinic as part of standard of care.
15818302|NCT04299087|Device|repetitive Transcranial Magnetic Stimulation (rTMS)|Repetitive transcranial magnetic stimulation (rTMS) is a form of brain stimulation therapy using a magnet to target and stimulate certain areas of the brain.
15818303|NCT04299087|Other|Control group|No application of rTMS
15818304|NCT04299074|Other|addiction|questionnaire
15818305|NCT04299061|Diagnostic Test|International Physical Activity Questionnaire|"This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting. Walking = 3.3 METs Moderate Intensity = 4.0 METs Vigorous Intensity = 8.0 METs Total MET-minutes/week = Walk (METs*min*days) + Mod (METs*min*days) + Vig (METs*min*days)
~1. Low: • No activity is reported OR • Some activity is reported but not enough to meet Categories 2 or 3. 2. Moderate: • 3 or more days of vigorous activity of at least 20 minutes per day OR • 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day OR • 5 or more days of any combination of walking, moderate-intensity or vigorous intensity activities achieving a minimum of at least 600 MET-minutes/week. 3. High: • Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/week"
15818306|NCT04299061|Diagnostic Test|Pittsburgh Sleep Quality Index|"The Pittsburgh Sleep Quality Index (PSQI) is an effective instrument used to measure the quality and patterns of sleep. It differentiates poor from good sleep by measuring seven domains: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction over the last month.The client self rates each of these seven areas of sleep. Scoring of the answers is based on a 0 to 3 scale, whereby 3 reflects the negative extreme on the Likert Scale. A global sum of 5or greater indicates a poor sleeper."
15818307|NCT04299061|Other|Physical Activity Awareness Questionnaire - prepared by the researchers|It consists of 13 questions to assess the physical activity level awareness of students. The questionnaire was prepared by the researchers therefore it does not have a validation.
15818308|NCT04299061|Diagnostic Test|Perceived Stress Scale|The Perceived Stress Scale (PSS) is a classic stress assessment instrument that helps understand how different situations affect feelings and perceived stress. The questions in this scale ask about feelings and thoughts during the last month. It consists of 14 questions.
15818309|NCT04299048|Drug|PF-06946860|subcutaneous injection
15818310|NCT04299035|Procedure|Erector spinae plane block|Erector spinae plane block
15818311|NCT04299022|Other|Vivigen Cellular Bone Matrix|Allograft bone matrix
15818312|NCT04299009|Device|Bright light therapy glasses|Bright light therapy delivered through glasses
15818313|NCT04298996|Diagnostic Test|taking saliva samples to determine oxidative stress markers TAS and TOS|
15818314|NCT04298983|Drug|Abemaciclib 150 MG by mouth twice daily|Abemaciclib will start with initiation of ADT, 3 months before RT, and pause 2 weeks prior to start of RT. Abemaciclib will resume with the first ADT administration post-radiation, which is about 1 month post radiation therapy. Abemaciclib will continue for a total of 24 months.
15818315|NCT04298983|Drug|Androgen deprivation therapy (ADT)|ADT will be given every 3 months. ADT and Abemaciclib will pause 2 weeks prior to start of RT. ADT administration will resume with Abemaciclib post-radiation, which is about 1 month post radiation therapy. ADT will continue for a total of 24 months.
15818316|NCT04298983|Radiation|Radiation Therapy|RT will start 3 months after initiation of ADT and Abemaciclib. RT will be given as standard of care- 180 cGy x 28 fractions to the whole pelvis and the prostate will receive 250 cGy x 28 fractions. After RT is completed, both ADT and Abemaciclib will resume and continue for 24 months.
15818317|NCT04298970|Dietary Supplement|Intervention|Freeze-dried Brassica oleracea var. acephala
15818318|NCT04298970|Dietary Supplement|Placebo|Placebo product
15818324|NCT04298931|Other|Series of ventilator settings|"Before a planned fluid administration, the investigators will apply a series of 10 ventilator settings for 30 seconds each.
~The settings are the following combinations of respiratory rate (RR) and tidal volume (TV):
~RR (min^-1), TV (ml/kg predicted body weight)
~31, 6
~31, 8
~24, 6
~24, 8
~17, 6
~17, 8
~10, 4
~10, 6
~10, 8
~10, 10
~(the order of the respiratory rates: 17 to 31, will be randomized. 10/min will always be last. Tidal volume is always applied from lowest to highest for each respiratory rate)."
15818325|NCT04298918|Drug|Placebo|Participants will receive oral placebo in combination with trastuzumab emtansine.
15818326|NCT04298918|Drug|Venetoclax|Participants will receive oral venetoclax.
15818327|NCT04298918|Drug|Trastuzumab emtansine|Participants will receive intravenous (IV) trastuzumab emtansine.
15818328|NCT04298905|Other|CHW mHealth patient intervention for trigger escalation|"The CHW dashboard is a tablet-based, per-patient summary of the patient intervention. It is this dashboard that identifies a trigger to escalate the adherence intervention. This dashboard is created by receiving information from the patient's smartphone application as well as the National Health Laboratory Service (NHLS) data feed of laboratory results. The monitoring features included in this dashboard:
~NHLS laboratory results: Dashboard receives and flags NHLS results for any positive smear or culture (new positive after prior negative results) or detectable viral load (with prior viral suppression)
~Triggered, escalating adherence coaching:
~Safety monitoring: reports all abnormal laboratory values to provider
~Appointment keeping (RETAIN):
~a. Triggered, escalating adherence coaching
~vDOT submissions:
~a. Triggered, escalating adherence coaching
~Symptom reports:
~Triggered, escalating adherence coaching"
15818329|NCT04298892|Other|clinical data and sample collection|Patients with hematologic malignancies and disorders will be asked to donate part of the samples collected as per clinical practice for the management of their disease for the aims of this study. In addition, patients will be asked to donate one oral swab sample, and urine samples. Collection of these additional samples is a non-invasive procedure with no associated risks for patients. Clinical data (demographics including ethnicity, stage of disease, concise treatment history, cytogenetic reports, and molecular data if available, as routinely performed during diagnosis procedures) will be collected.
15818330|NCT04298879|Drug|IBI376|IBI376 20 mg po. once daily for 8 weeks ，followed by 2.5mg once daily
15818331|NCT04298866|Other|Experimental Arm|"3T MRI, maximum 1H30 long duration, including diffusion tensor imaging, susceptibility weighted imaging, multiparametric acquisitions, without contrast perfusion acquisitions.
~7T MRI, maximum 1H30 long duration, including contrast enhanced acquisitions
~Neuropsychological battery including chronometric measures obtained through a computer interface"
15818332|NCT04298853|Drug|Morphine PRN|Dose given every 3 hours as-needed for severe NAS, defined by a threshold Finnegan score.
15818333|NCT04298853|Drug|Morphine scheduled|Dose given every 3 hours on a scheduled basis and slowly weaned once stabilized.
15818334|NCT04298840|Dietary Supplement|Creatine Monohydrate Supplementation|Participants in the creatine monohydrate supplementation arm will consume 5 grams per day of creatine monohydrate.
15818335|NCT04298840|Dietary Supplement|Placebo Supplementation|Participants in the placebo supplementation arm will consume 5 grams per day of maltodextrin placebo.
15818336|NCT04298827|Other|Unimodal|Patients will receive physical therapy alone.
15818337|NCT04298827|Other|Trimodal|Patients will receive physical therapy, nutrition counseling, and cognitive behavioral therapy in the form of group counseling.
15818338|NCT04298814|Other|severe covid-19 pneumonia with ET|severe covid-19 pneumonia undergoing endotracheal intubation
15818339|NCT04298801|Procedure|Nurse-driven HIV screening for key populations combined with usual physician-directed diagnostic testing|"A self-administered questionnaire on HIV exposure factors will be offered to all patients of ages 18-64 able to complete it. This questionnaire will be available in a paper-based format, electronic format on the patient phone or can be conducted verbally by the nurse. According to the answers, the nurses will suggest performing a rapid test to patients belonging to key populations. A finger-stick rapid HIV test will be performed and results will be disclosed by the nurse assisted by a physician if necessary.
~If needed, a follow-up visit with an infectious disease specialist will be scheduled within 72 hours."
15818340|NCT04298801|Other|Physician-directed diagnostic testing|Throughout the intervention, physicians will prescribe HIV tests to patients with HIV-related symptoms, following usual practice.
15818341|NCT04298788|Other|Blue dishware|blue dishware is used for plates and bowls
15818342|NCT04298775|Procedure|spinal anesthesia with morphine|
15818343|NCT04298775|Procedure|spinal anesthesia without morphine + peripheral nerve block|
15818344|NCT04298762|Other|No peer comparison email|The comparison group received no email communication on their cancer stage documentation activity.
15818345|NCT04298762|Other|Peer comparison email|The intervention group received three separate emails with individualized data on their cancer stage documentation activity in the previous 1-3 months. The email described the number and percent of attributed patients for whom cancer stage was documented, and included a figure showing their staging documentation rate compared to their peers.
15818346|NCT04298749|Drug|GX-P1 or Placebo (dose level 1)|GX-P1 dose level 1 or placebo
15818347|NCT04298749|Drug|GX-P1 or Placebo (dose level 2)|GX-P1 dose level 2 or placebo
15818348|NCT04298749|Drug|GX-P1 or Placebo (dose level 3)|GX-P1 dose level 3 or placebo
15818349|NCT04298736|Procedure|Bariatric Surgery|laparoscopic Roux-en-Y gastric bypass or laparoscopic Sleeve Gastrectomy
15818350|NCT04298736|Behavioral|Lifestyle modification|guided low-calorie diet and physical activity.
15818351|NCT04298723|Device|Percutaneous closure of the LAA (Watchman / Watchman FLX)|LAA closure procedure will be done by experienced operators according to the local SOP. LAA closure will be performed under fluoroscopic and TEE guidance within conscious sedation or general anesthesia. Antibiotic single-shot prophylaxis should be administered peri-procedurally (i.e., cefazolin 2 g). The specific anatomy of the LAA is evaluated and an appropriately sized CE-marked device (WatchmanTM or Watchman FLXTM) is deployed. LAA angiography and TEE imaging is performed to identify optimal positioning of the device and to exclude a relevant leak. Following device deployment, patients will receive a therapy according to the manufacturers IFU, currently Aspirin and clopidogrel for 3 months followed by single Aspirin up to 12 months. Alternatively, 3 months of NOAC followed by Aspirin monotherapy up to 12 months are possible.
15818352|NCT04298710|Behavioral|Arm Cycling|20 minutes of arm cycling exercise at light to moderate intensity.
15818353|NCT04298710|Behavioral|Leg Cycling|20 minutes of leg cycling exercise at light to moderate intensity.
15818354|NCT04298710|Behavioral|Sitting|Remain seated for 20 minutes.
15818355|NCT04298697|Drug|TDF/FTC Dose Schedule for Arm A|TDF/FTC is a combination anti-HIV medication that contains the drugs tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg). Participants will take 2 pills on Study Day 1, then one pill per day on Study Days 2 and 3. Participants will have biologic specimens collected at specific time points until 28 days after the last dose.
15818356|NCT04298697|Drug|TDF/FTC Dose Schedule for Arm B|TDF/FTC is a combination anti-HIV medication that contains the drugs tenofovir disoproxil fumarate (300 mg) and emtricitabine (200 mg). Participants will be on a weekly dosing schedule of 2 pills on the first day, followed by one pill per day for the next two days. They will follow this dosing schedule for four weeks. Participants will have biologic specimens collected at specific time points until 28 days after the last dose.
15818357|NCT04298684|Drug|METFORMIN|"After inclusion, a central randomization will allow subjects to benefit from either metformin (group 1) or sitagliptin (group 2). A follow-up schedule will be given to the included patient for future visits. thyroid ultrasonography to analyze the TN evolution in the 2 groups.
~In arm 1, the subjects will receive metformin at the initial dose of 500mg x 2 / day, which will be increased weekly to 500mgx3 / day and then 1gx2 / day in order to obtain the minimum effective dose on glycemic control. In case of intolerance, the tolerated and effective dose will be taken back provided an effective glycemic control.
~A classic follow-up will be done every 3 months. Thyroid US and measure of HOMA-IR index will be done every 6 months for 2 years. If the goal of HbA1c will not achieved, a treatment with glicazide will be introduced."
15818358|NCT04298684|Drug|Sitagliptin|"After inclusion, a central randomization will allow subjects to benefit from either metformin (group 1) or sitagliptin (group 2). A follow-up schedule will be given to the included patient for future visits. thyroid ultrasonography to analyze the TN evolution in the 2 groups.
~In arm 2, sitagliptin will be prescribed at 100mg / day. A classic follow-up will be done every 3 months. Thyroid US and measure of HOMA-IR index will be done every 6 months for 2 years. If the goal of HbA1c will not achieved, a treatment with glicazide will be introduced."
15818359|NCT04298671|Behavioral|Yoga-Pilates|As above
15818360|NCT04298658|Diagnostic Test|Structured Clinical Interview for Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)sleep disorders-revised|Structured Clinical Interview For DSM-5 Sleep Disorders-Revised (SCISD-R) - is a semi structured interview for diagnosing sleep disorders according to Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5)
15818361|NCT04298658|Diagnostic Test|Resmed ApneaLink Air device (Resmed, San Diego, CA).|Home Sleep Test (HST) will measure airflow (i.e., nasal pressure) using a nasal cannula and oxygen saturation to identify apnea and hypopnea and calculate an apnea hypopnea index (AHI; number of apnea and hypopnea per hour).
15818362|NCT04298658|Other|Quantitative Sensory testing (QST)|All participants will undergo quantitative sensory testing for assessment of endogenous pain modulation using painful heat, mechanical, and cold stimuli in a laboratory session lasting approximately 1 hour.
15818363|NCT04298658|Diagnostic Test|OraQuick Advance Rapid HIV 1/2 Swab test|Participants who have an HIV negative status will complete the OraQuick Advance Rapid HIV 1/2 Swab test to confirm negative status.
15818364|NCT04298658|Diagnostic Test|Cluster of Differentiation 4 (CD4) and Viral load|Participants who have an HIV positive status will have blood tested for cluster of differentiation 4 (CD4) and Viral load to confirm positive status.
15818365|NCT04298645|Other|Glycaemic response to high GI carbohydrates consumed at morning versus evening meals.|Controlled nutrition trial on the glycaemic response to morning and evening meals with high glycemic index carbohydrates among students with early and late chronotypes.
15818366|NCT04298632|Behavioral|Safety Education Program|this is a pesticide safety education program
15818367|NCT04298619|Diagnostic Test|Standard cohort: Clinical lab follow-up|
15818368|NCT04298619|Diagnostic Test|Imaging cohort: integrated imaging follow-up|
15818369|NCT04298606|Other|Quality-of-Life Assessment|Ancillary studies
15818370|NCT04298606|Other|Questionnaire Administration|Ancillary studies
15818371|NCT04298606|Biological|Recombinant Human EGF-rP64K/Montanide ISA 51 Vaccine|Given IM
15818372|NCT04298593|Device|Cardiostat|This is a prospective observational study including patients accepted by the heart team for a TAVI procedure. There will be no restriction regarding the type of valve and approach used for the TAVI procedure. Following the TAVI procedure, the patients will be under telemetry until hospital discharge and, at hospital discharge, they will be monitorized up to 4 more weeks using the CardioSTAT® device.
15818373|NCT04298580|Procedure|PVB block|PVB block before surgery versus after surgery
15818374|NCT04298567|Drug|Rivaroxaban (Xarelto,Bay 59-7939)|Rivaroxaban (2.5 mg [BID])
15818375|NCT04298567|Drug|Acetylsalicylic acid(ASA)|ASA (75mg [QD]; dose according to local label.
15818376|NCT04298554|Other|CBD Oil|CBD PURE CBD OIL 20mg/1ml concentration
15818377|NCT04298554|Other|Hemp Oil|CBD PURE HEMP OIL
15818378|NCT04298541|Drug|Ga-68- DOTATATE|"The study intervention consists of two PET/CT scans that will be performed using two different radiotracers, 68-Ga-DOTATATE and 68-Ga-DOTATOC. Ga-68-DOTATATE and 68-Ga-DOTATOC are PET radiotracers targeting somatostatin receptors.
~The study intervention consists of 2 PET/CT scans that will be performed at least 24h apart using 68-Ga-DOTATATE and 68-Ga-DOTATOC radiotracers, in patients with suspected meningioma that are planned for subsequent surgery."
15818379|NCT04298541|Drug|Ga-68-DOTATOC|"The study intervention consists of two PET/CT scans that will be performed using two different radiotracers, 68-Ga-DOTATATE and 68-Ga-DOTATOC. Ga-68-DOTATATE and 68-Ga-DOTATOC are PET radiotracers targeting somatostatin receptors.
~The study intervention consists of 2 PET/CT scans that will be performed at least 24h apart using 68-Ga-DOTATATE and 68-Ga-DOTATOC radiotracers, in patients with suspected meningioma that are planned for subsequent surgery."
15818380|NCT04298528|Drug|Dronabinol|2.5mg 2 times a day for 30 days after total knee replacement
15818381|NCT04298528|Other|Placebo|2 times a day for 30 days after total knee replacement
15818382|NCT04298515|Diagnostic Test|Nesfatin-1|Blood will be taken from the patients on an empty stomach for measuring nesfatin-1 level
15818535|NCT04297306|Device|Exercise Prescription and Virtual Reality Exercise Gaming support|Standardised Exercise Prescription with the additional support of Virtual Reality Promoted Exercise Games.
15818857|NCT04294576|Drug|BJ-001|BJ-001 dosed via SC injection as single agent. One cycle is 6 weeks.
15818383|NCT04298489|Diagnostic Test|Personalized drug sensitivity test|"The patients underwent surgery to remove tumor and took out tumor specimens for research. The tumor cells were expanded ex vivo drug sensitivity assay.
~The drugs used in the study were 5-fluorouracil, Oxaliplatin, and irinotecan at C0 = 10 mM, 2.5 mM and 0.02 mM, respectively. They were applied either as single agents or in combinations of 5-fluorouracil and Oxaliplatin, 5-fluorouracil and irinotecan, or all three agents, or others. After 7 days of treatment, the tumor cells were stained with EdU, Hoechst and EpCAM with the Cell Quantitative Detection Kit. Images were acquired with an automated microscopic image-scanning system and analyzed with the built-in software."
15818384|NCT04298476|Procedure|Placement of an adductor canal nerve block|An adductor canal nerve block will be placed in a patient undergoing a knee arthroscopy in 1 of 3 locations with local anesthetic or placebo (without location definition or local anesthetic) to assess optimal placement of local anesthetic, pain management and anxiety scores post operatively.
15818385|NCT04298463|Drug|Xydalba|Drugs were administered i.v.
15818386|NCT04298463|Drug|vancomycin, teicoplanin or daptomycin|Drugs were administered i.v.
15818387|NCT04298450|Behavioral|Active SMS Intervention|Welcome message letting participant know they will be contacted to book an appointment, followed by appointment reminders and other clinic information, psychoeducational materials, and a distress check-in with two-way feedback to their care team, all sent by SMS/text message at the participant's preferred time of day. If they indicate that they are in high distress, or they request, their care provider will be notified and asked to reach out to them. They will also receive crisis resources.The intervention will continue until the patient attends the first consultation appointment, or for up to 30 days if the patient does not attend, which reflects the program's practice of closing referrals for non-attending patients.
15818388|NCT04298450|Behavioral|Sham SMS|Single welcome message letting participant know they will be contacted to book an appointment.
15818389|NCT04298437|Behavioral|Addressing Depression and Positive Parenting Techniques (ADAPT) Program|The intervention is a targeted parenting intervention that has modules that help parents build emotion regulation skills, distress tolerance skills and alternative and more helpful ways of thinking about the causes of their child's EBD. The program also includes behavioral parent training skills building modules.
15818390|NCT04298424|Other|PLSM|The program was designed for implementation over 4 consecutive weeks, with groups of 6-8 people each attending one 60-90-minute class per week. Peer leaders lead the groups to promote interaction, sharing, and support, and assist in goal setting to address behavior-related health problems, and thereby the development and implementation of strategies to achieve suitable, sustainable, and feasible self-management behavior.
15818391|NCT04298411|Device|Falcon|The Falcon contains a selection of 25+ games that require wrist extension and challenges children to grasp the controller with their affected hand. As children progress, they may advance to more difficult games that challenge the child to work against a resistance and/or apply greater grip forces. Therapists will be trained on the system, games, and given a guide summarizing the available games and the motor function areas targeted in the game. Using this guide, therapists can choose the games that are most suited to the child's abilities and goals. As multiple games will target many of the same motor function areas, children will have the option of choosing the games they like best to maximize motivational value. While this introduces some variability in the intervention, this flexibility is required to ensure that the therapy is targeting the specific interests, needs and goals of each individual child and is reflective of how ICP is used in a clinic setting.
15818392|NCT04298398|Behavioral|Mindfulness Based-Cognitive Therapy (MBCT)|MBCT is a program developed by Zindel Segal, Mark Williams and John Teasdale. During MBCT patients learn to decenter their negative thoughts and feelings, allowing the mind to move from an automatic thought pattern to conscious emotional processing. Mindfulness practices included in this program are breath awareness, body scan, sitting and walking meditation, and mindful yoga. The intervention will have the following structure: 8 weekly face-to-face meetings of 2 hours in a group format, daily home-based practice of learned skills, 4 hours of retreat/intensive group work after the fifth week, 6 months of home practice, 4 monthly consolidation face-to-face sessions.
15818393|NCT04298398|Behavioral|Emotion Focused Therapy Group for Cancer Recovery (EFT-CR)|EFT-CR is an evidence-based approach to psychotherapy, which combines aspects of person-centered, gestalt and existential therapies with contemporary emotion theory and dialectical constructivism (Elliott et al, 2004, Rice & Greenberg, 1984). On EFT-CR, therapist follows the client experience and guides the process, proposing therapeutic tasks when specific client behaviors occur. EFT-CR uses a set of emotion change principles which guide a process of emotional deepening process, from undifferentiated distress to secondary reactive emotions to primary maladaptive emotions to core pain and thence to primary adaptive emotions and emotional transformation (Elliott & Greenberg 2016). The intervention will have the following structure: 8 weekly face-to-face meetings of 2 hours in a group format, daily home-based practice of learned skills, 4 hours of retreat/intensive group work after the fifth week, 6 months of home practice, 4 monthly consolidation face-to-face sessions.
15818394|NCT04298398|Other|Treatment as usual (no intervention)|Treatment as Usual is the condition in which participants will follow the usual institutional intervention protocol for medical follow-up and identification, referral and intervention for people identified with significant distress difficulties.
15818395|NCT04298385|Other|Traction orthosis|Traction applied to a finger using elastic thread and sports tape and attached to an orthosis
15818396|NCT04298372|Drug|Lenalidomide 25mg|"As single arm study, patients will be treated as follows:
~Lenalidomide : D1~D21 daily oral administration, starting dose 15mg, with an increase of 5mg every cycle, if tolerated, up to 25mg.
~Dexamethasone : D1~D4 daily oral administration or intravenous injection, 40mg(or 20mg for age for age ≥ 65 years old) Patients will be treated every 4 weeks as one cycle, and up to 12 cycles of treatment will be conducted."
15818397|NCT04298346|Other|no intervention|no intervention
15818536|NCT04297293|Drug|Ramosetron|Ramosetron orally disintegrating tablet 0.1 mg is administered after discharge (postoperative day 1 and day 2)
15818537|NCT04297280|Drug|Sintilimab|a PD-1 immune check inhibitor
15818538|NCT04297280|Combination Product|TACE|TACE is performed by using drug eluting beads, or using microspheres combined with Lipiodol-pirarubicin emulsion per Investigator decision
15818539|NCT04297267|Drug|Gemcitabine|Gemcitabine 1250mg/m2,d1,d8,every 3 weeks
15818540|NCT04297267|Drug|Cisplatin|Cisplatin 75mg/m2,d1，every 3 weeks
15818541|NCT04297254|Drug|Lenvatinib|Lenvatinib capsules.
15818398|NCT04298333|Drug|BP-C1|"BP-C1, 0.05% solution for injection, will be administered intramuscularly once per day. The cumulative dose range will be 0.64-1.12 mg/kg body weight depending on design level (design level 1-3). The daily dose range will be 0.02-0.035 mg/kg body weight (0.04-0.07 mL/kg) depending on design level (design level 1-3).
~Dose level 1: 0.02 mg/kg body weight (0.04 mL/kg) intramuscularly once daily for 32 consecutive days; dose level 2: 0.03 mg/kg body weight (0.06 mL/kg) intramuscularly once daily for 32 consecutive days; dose level 3: 0.035 mg/kg body weight (0.07 mL/kg) intramuscularly once daily for 32 consecutive days.
~Changes in the cumulative dose of BP-C1 between patients in the sequence are predefined and will be adjusted by escalation/deescalation rules based on changes in toxicity observed in the previous design level.
~The duration of BP-C1 treatment will be 32 days."
15818399|NCT04298320|Drug|SHR-1210|SHR-1210 was administered 200mg iv every 2 weeks
15818400|NCT04298320|Drug|AIN 457|AIN457 was administered 150mg or 300mg ih every 2 weeks
15818401|NCT04298307|Other|Intracoronary lithotripsy (ICL)|ICL using the Shockwave catheter.
15818402|NCT04298294|Other|injectable platelet rich fibrin|biologic activator
15818403|NCT04298268|Device|CUSA Clarity Ultrasonic Surgical Aspirator System use|Assessment of the CUSA® Clarity Ultrasonic Surgical Aspirator System use during urological or general surgery for soft tissue removal
15818404|NCT04298255|Other|Round Spermatid Injection (ROSI)|In Vitro Fertilization using Round Spermatid Injection (ROSI)
15818405|NCT04298255|Other|Half ROSI-half Sperm Donor Fertilization|Half ROSI-half Sperm Donor Fertilization
15818406|NCT04298242|Device|ExAblate 2100|A non-invasive thermal ablation device fully integrated with an MR imaging system
15818407|NCT04298229|Drug|Dapagliflozin 10 MG|SGLT2 inhibitors being investigated for its diuretic and natriuretic effects on top of protocolized diuretic therapy.
15818408|NCT04298229|Other|Protocolized Diuretic Therapy|Structured usual care arm with protocolized diuretic therapy based on urine output.
15818409|NCT04298216|Diagnostic Test|Ultrasound Analysis of Inferior Vena Cavae (IVC)|Novel Operators will attempt to visualize the Inferior Vena Cavae through two different views on the patient's body. The images taken will be interpreted by an expert ultrasound user to determine if the novel operator was successful in locating and evaluating the IVC.
15818413|NCT04298190|Behavioral|Dialectical Behaviour Therapy for Adolescents (DBT-A)|"16 weeks of Dialectical behavior therapy with one weekly session of individual therapy, one weekly session of multifamily skills training group, telephone coaching and ancillary family therapy and/or pharmacological treatment as needed.
~The treatment has been developed by Marsha Linehan (Linehan, 1993a; 1993b)and adapted for adolescents by Alec Miller (Miller, Rathus & Linehan, 2007). Individual DBT therapists have been trained by drs Alec L Miller and Sarah K Reynolds and have a minimum of one year clinical practise as DBT therapists. The therapists are organised in two consultation teams supervised on a bimonthly basis throughout the entire study by drs Miller and Reynolds respectively."
15818414|NCT04298190|Behavioral|Enhanced usual care|16 weeks of outpatient treatment in child and adolescent psychiatric clinics in Oslo, on average one weekly session of individual therapy and ancillary supportive family and/or pharmacological treatment as needed.
15818415|NCT04298177|Device|Atrial fibrillation ablation using the QDOT® catheter|Atrial fibrillation ablation will be performed using the QDOT® catheter. The ablation mode will be selected according to the MDCT-derived LAWT information.
15818416|NCT04298177|Procedure|Standard atrial fibrillation ablation|Atrial fibrillation ablation will be performed using the SmartTouch® catheter. The ablation parameters will be adjusted according to the settings previously described in the CLOSE study.
15818417|NCT04298164|Behavioral|START programme|Acceptance and Commitment Therapy based programme for parents of children with Autism
15818418|NCT04298164|Behavioral|Treatment as Usual|Treatment as usual in outpatient within outpatient psychology services
15818419|NCT04298151|Drug|Zirconomer Improved|glass ionomer restoration reinforced with nano-zirconia particles to improve strength and esthetics
15818420|NCT04298151|Drug|Ketac Molar Aplicap|highly viscous glass ionomer with improved mechanical properties than the conventional GI
15818421|NCT04298138|Biological|Dengue virus 3 Live Virus Human Challenge (DENV-3-LVHC)|Dengue subtype 3 Challenge Virus (DENV-3) strain CH53489 administered as a single injection.
15818422|NCT04298125|Behavioral|Exercise in Pregnancy|Women in this group will participate in psychical activity 3 times per week in their community setting.
15818423|NCT04298112|Diagnostic Test|PSMA PET/CT|Whole-body PET/CT (contrast enhanced CT or low-dose CT); from vertex to thighs.
15818424|NCT04298112|Diagnostic Test|PSMA PET/MR|Pelvic PET/MR in addition to targeted PET/MR according to other findings from the PET/CT (e.g. columna)
15818425|NCT04298099|Drug|Ropivacaine|Given the reproducible efficacy of the erector spinae plane block for thoracic procedures, this pilot study will recruit patients scheduled to undergo thoracic surgery with the adjunct of an erector spinae plane block for perioperative pain. Participants will be assigned sequentially to either ropivacaine 0.2% at 0.3ml/kg or ropivacaine 0.5% at 0.3ml/kg.
15818426|NCT04298086|Other|Exercise Treatment|Exercise treatment will consist of individualized walking delivered up to 7 times weekly to achieve the patient-specific goal energy expenditure. Training sessions will be performed on a treadmill at MSK or under remote surveillance using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service.
15818427|NCT04298086|Other|Plant-Based Diet|Pre-prepared meals, including 6 dinners and 6 lunches per week, will be shipped to the partipant's home during the intervention.
15818428|NCT04298086|Other|Physical activity|Treadmills and low-calorie recipes will be provided to patients in the counseling arm.
15818429|NCT04298086|Other|Nutrition counseling|Nutrition program including regular counseling by exercise physiologists and registered dieticians (RDs).
15818430|NCT04298086|Other|Replication Exercise Test|Exercise capacity will be reassessed by a replication exercise test at week 6 in the intervention group only.
15818431|NCT04298060|Drug|DAS181|SD (4.5mg/day), HD (9mg/day)
15818432|NCT04298060|Drug|Placebo|Placebo 0mg/day
15818433|NCT04298047|Other|participatory art-based activity|The intervention is a 3-month cycle of weekly guided tours carried out at the MMFA. Each visit will be performed with a group of 8 participants and a trained guide. They will meet at the museum once per week for a 45 min museum guided tour during a 3-month period. Each visit will be different and supervised by a museum guide. Regardless the topic of the visits, each visit will be standardized and separated in two consecutive phases: (1) Presentation of the objectives of the activity and (2) tour with a guide. Guided tours will target visual art (i.e., painting). They will be tailor-made and based on emotions and interactions in front of painting. The levels of information given to participants will regularly (i.e., each month) increase during the 3-month cycle of museum guided tours. The participants will be separated in 8 groups of 8 individuals per week. The same guide will manage each group of 8 participants during the 12 planned visits.
15818434|NCT04298034|Drug|Labetalol, Nifedipine|Antihypertensive treatment that is safe and well studied in peripartum women.
15818435|NCT04298021|Drug|AZD6738|"In AZD6738+Durvalumab cohort
~- AZD6738 240 mg bid on D15-D28 Every 4 weeks
~In AZD6738+ Olaparib cohort - AZD6738 160 mg qd on D1-7 Every 4 weeks"
15818436|NCT04298021|Drug|Durvalumab|Durvalumab 1500 mg iv on D1 Every 4 weeks
15818437|NCT04298021|Drug|Olaparib|Olaparib 300 mg bid on D1-28 Every 4 weeks
15818438|NCT04298008|Drug|AZD6738|AZD6738 (240 ) mg bid on D15-D28 Every 4 weeks
15818439|NCT04298008|Drug|Durvalumab|Durvalumab 1500 mg iv on D1 Every 4 weeks
15818440|NCT04297995|Drug|Experimental: Stage 1L: HLX10 Plus HLX07|3 mg/kg of HLX10 every two weeks infusion combined with 600 mg HLX07 weekly
15818441|NCT04297995|Drug|Experimental: Stage 1H: HLX10 Plus HLX07|3 mg/kg of HLX10 every two weeks infusion combined with 800 mg HLX07 weekly
15818442|NCT04297982|Other|Mandala Activity|Mandala is a method of expressing one's feelings and thoughts. The person draws and paints the paper in a round shape.
15818443|NCT04297982|Other|Routine nursing care|Interventions routinely implemented by nurses in the clinic
15818444|NCT04297969|Diagnostic Test|"objective pediatric vision screen GCK glow fixation"|2-axis, smart phone flash concentrated photoscreen using novel, low-detail, color glow fixation device
15818445|NCT04297943|Device|Orthosis fabrication|see summary
15818446|NCT04297943|Device|Thermal Sensor Monitoring of Orthosis Use|see summary
15818447|NCT04297943|Diagnostic Test|4D CT Scan|see summary
15818448|NCT04297930|Device|Paul Glaucoma Implant Surgery|This group of patients had glaucoma surgery with the Paul Glaucoma Implant
15818450|NCT04297904|Behavioral|Sedentary behaviour|To assess sedentary behaviour each participant will wear an activity monitor (PAL Technologies, Scotland). The resident will wear the monitor on their right thigh for 24 hours per day over seven days continuously.
15818451|NCT04297904|Diagnostic Test|Urinary Incontinence|The presence of IU, assessed by the Minimum Data Set (MDS) version 3.0, and used together with the International Consultation on Incontinence Questionnaire-Short Form to characterize the incontinence.
15818452|NCT04297891|Other|Clinical rating scale to measure Ataxia disease severity and progression|SARA is a clinical scale developed by Schmitz-Hübsch et al which assesses a range of different impairments in cerebellar ataxia. The scale is made up of 8 items related to gait, stance, sitting, speech, finger-chase test, nose-finger test, fast alternating movements and heel-shin test.
15818453|NCT04297891|Other|Clinical rating scale to measure spastic paraplegia disease severity and progression|A 13-item scale to rate functional impairment occurring in pure forms of spastic paraplegia (SP). Additional symptoms constituting a complicated form of SP are recorded in an inventory.
15818454|NCT04297891|Other|Disease-specific severity index for adults with autosomal recessive spastic ataxia of Charlevoix-Saguenay (ARSACS)|"The DSI-ARSACS is a valid measure of disease severity for the adult ARSACS population that is able to distinguish between patients with different clinical profiles.
~It considers the 3 components (pyramidal, cerebellar, neuropathic) of the disease, and documents its content validity, internal consistency, and construct validity."
15818455|NCT04297891|Diagnostic Test|Next-Gen Sequencing (NGS)|Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics
15818456|NCT04297878|Dietary Supplement|probiotic supplement Streptococcus salivarius K12 (Bactoblis®)|Probiotic food supplement
15818457|NCT04297865|Drug|A dose as CJ-15314|A dose as CJ-15314, 1 capsule
15818458|NCT04297865|Drug|B dose as CJ-15314|B dose as CJ-15314, 1 capsule
15818459|NCT04297865|Drug|C dose as CJ-15314|C dose as CJ-15314, 1 capsule
15818460|NCT04297865|Drug|D dose as CJ-15314|D dose as CJ-15314, 2 capsules
15818461|NCT04297865|Drug|E dose as CJ-15314|E dose as CJ-15314, 1 capsule
15818462|NCT04297865|Drug|F dose as CJ-15314|F dose as CJ-15314, 2 capsules
15818463|NCT04297865|Drug|Placebo|Placebo, 1 capsule
15818464|NCT04297865|Drug|Placebo|Placebo, 1 capsule
15818465|NCT04297865|Drug|Placebo|Placebo, 1 capsule
15818466|NCT04297865|Drug|Placebo|Placebo, 2 capsules
15818467|NCT04297865|Drug|Placebo|Placebo, 1 capsule
15818468|NCT04297865|Drug|Placebo|Placebo, 2 capsules
15818469|NCT04297852|Dietary Supplement|Vegan drink|Vegan based drink containing vegetables, fruits and plant oils. Dose: 500 mL a day
15818470|NCT04297852|Dietary Supplement|Control|Placebo drink Dose: 500 mL a day
15818471|NCT04297839|Drug|Citrate Anticoagulation Solution|Regional citrate anticoagulation in extended hemodialysis sessions compared to the standard of care actually performed in these therapies (heparin or continuous saline infusion)
15818472|NCT04297839|Drug|Control Group (heparin or continuous saline)|Use of heparin in hemodialysis sessions. If there is any contraindication against the use of heparina, the investigators will perform saline flush of the dialysis system
15818473|NCT04297826|Behavioral|Harvest for Health|Please see previous description
15818474|NCT04297813|Combination Product|Advanced medicinal Therapy (MSC combined with biomaterial)|Augmentation of alveolar ridge with MSC and biomaterial
15818475|NCT04297813|Procedure|Autologous bone graft|Augmentation of the alveolar ridge with bone graft
15818542|NCT04297241|Drug|Isosorbide Dinitrate|All patients will be given a 6 week titration regimen of study medication. Patients will begin at a 5mg dosage and titrate up to 30mg three times per day if each subsequent dose is tolerated.
15818476|NCT04297787|Device|Thrombolysis in combination with endhole aspiration|The treatment protocol the study team will be following is as follows. First, a pulse spray tPA infusion with 20 cc of 8 mg tPA and saline will be administered to the thrombus with a 20-minute dwell time. Afterwards, an 8F curved sheath (Indigo 8 Torq Tip, ranges 85 to 115 cm) with CAT8 penumbra device will be used to aspirate the thrombus. If the operating physician deems necessary, they will have the option at that point to balloon plasty, stent, or use catheter-directed thrombolysis at this point. Clinical parameters such as areas of clinically-significant stenosis, extent of thrombus, (more parameters) will be tracked at the time of the procedure. The device is being used is FDA approved and being used according to FDA indications.
15818477|NCT04297774|Behavioral|virtual reality treatment|18 virtual reality training through Pablo system (30 minutes a time, 2-3 times a week). Postural transition included sit-to-stand, sit down, reaching to different directions, stepping to different directions with weight transfer, and bending the trunk forward and side to side. The controller was attached to lower extremity or trunk to control the game, such as elevator, hot air balloon, shooting cans, etc.
15818478|NCT04297774|Behavioral|standard treatment|18 standard rehabilitation sessions (60 minutes a time, 2-3 times a week). The rehabilitative protocol focus on strengthening, endurance training, ambulation, and ADL training that included: (1) Hip flexor and knee extensor strengthening with resistance progressing used by weight bag or Thera-band. (2) Cycle ergometer riding with increase speed and resistance. (3) Gait pattern and speed correcting through treadmill and parallel bar. (4) Hand functional training and strategy teaching for feeding, dressing, and toileting.
15818479|NCT04297774|Behavioral|balance training|18 balance training sessions (30 minutes a time, 2-3 times a week) (1) Facilitated the balance reaction through weight shifting exercise with standing on even surface to uneven surface, such as tilting board.(2) Postural transition included sit-to-stand, sit down, reaching to different directions, stepping to different directions with weight transfer, and bending the trunk forward and side to side. (3) Changed the standing requirement, such as single legged stance or lunge stance. (4) Increased perception complications through cognition or upper extremity task to improve dual task attention.
15818480|NCT04297761|Other|Filtered Air|Ambient air will be filtered and used for control exposure.
15818481|NCT04297761|Other|Wood Smoke|Wood smoke is generated by smoldering dry white oak logs and the exposure level will be maintained at an average of 500 µg/m^3 for 2 hours.
15818482|NCT04297748|Combination Product|89Zirconium-M7824|PET imaging agent
15818483|NCT04297748|Drug|M7824|Bifunctional fusion protein intended to block PD-L1 and neutralize TGFbeta simultaneously.
15818484|NCT04297735|Other|Standard of care group|Visits every 6 months is standard of care.
15818485|NCT04297735|Behavioral|Telemedicine group|Conduct monthly telemedicine 'skype' visit
15818486|NCT04297735|Behavioral|Telemedicine|Review details of medication indication and use, activity recommendations and changes, and knowledge of arrhythmia changes and activities which are helpful with arrhythmia changes.
15818487|NCT04297722|Other|Dairy products|Dairy consumption including total dairy, full-fat dairy, low-fat dairy, total milk, full-fat milk, low-fat milk, total yogurt, full-fat yogurt, low-fat yogurt, total cheese, hard cheese and fresh cheese
15818488|NCT04297696|Other|Therapeutic exercises|A program including warm-up period and neuromuscular exercises is applied progressively in two phases.
15818493|NCT04297670|Other|Measurement of HPV types prevalence|Self collected genital samples to be tested for the presence of different HPV types.
15818494|NCT04297657|Other|Counselling|o An appointment was made with the women in the experimental group at a time when they were available and a suitable environment was arranged in the hospital. The counselling programme of the experimental group was conducted in four sessions one week apart. In addition, each woman in the experimental group was given a counselling booklet and compact disc. The interviews lasted between 15- 45 minutes. The topics of interest among women were noted in the interviews and after the information on the subject was received, feedback was given to the relevant woman through a phone call.
15818495|NCT04297644|Other|There is no intervention|There is no intervention
15818496|NCT04297631|Drug|Tobramycin Powder|Everyone gets tobramycin powder.
15818497|NCT04297631|Device|Vancomyscin|Everyone gets the vancomyscin powder.
15818498|NCT04297618|Drug|Xiidra|Xiidra (lifitegrast 5% ophthalmic solution)
15818499|NCT04297605|Drug|Pembrolizumab|Pembrolizumab 200 mg
15818500|NCT04297605|Other|Pemetrexed (Chemotherapy)|500 mg/m2 day 1 of 21 day cycle (for non-squamous only)
15818501|NCT04297605|Other|Nab-paclitaxel (Chemotherapy)|100 mg/m2 days 1,8 of 21 day cycle x 4 cycles
15818502|NCT04297592|Drug|Cephalexin Oral Tablet|Default oral antibiotic option for participants in Group A.
15818503|NCT04297592|Drug|Doxycycline Hyclate|Oral antibiotic option for participants in Group A if they have preoperative nasal colonization of methicillin-resistant Staphylococcus aureus, allergy to cephalosporins or a creatinine clearance less than 60 mL/min.
15818504|NCT04297553|Procedure|CAPA-Fresh|Receiving FSH (Menopur, Ferring) for 2 days on day 2/3 of the menstrual cycle (spontaneous/ OCP administration) and an ultrasound scan will be performed subsequently. Oocytes retrieval will be performed 42 hours after the last injection. Receiving hCG 5000IU x 2 (10000IU) after Oocytes retrieval. Pre-maturation will last for 24-30 hours. ICSI will be used for insemination. Fresh embryos transfer will be performed on day 3 using HRT protocol with a maximum of 2 embryos transferred.
15818505|NCT04297553|Procedure|CAPA-Freeze-only|Receiving FSH (Menopur, Ferring) for 2 days on day 2/3 of the menstrual cycle (spontaneous/ OCP administration) and an ultrasound scan will be performed subsequently. Oocytes retrieval will be performed 42 hours after the last injection. Pre-maturation will last for 24-30 hours. ICSI will be used for insemination. Freeze-only on day 3 and frozen embryo transfer will be performed on the subsequent cycle using HRT protocol with a maximum of 2 embryos transferred.
15818543|NCT04297228|Behavioral|Step by Step: A Family-Centered Healthy Lifestyle Intervention|
15819723|NCT04287452|Other|Dog Therapy|Exposure to certified therapy dogs and their handler.
15818506|NCT04297540|Device|Active-tDCS group|Active anodal-tDCS will be delivered over the cerebellum for 8 sessions in two weeks. tDCS will be delivered via a battery driven direct current stimulator. Saline-soaked sponges electrodes will be placed on the cerebellar vermis (anodal electrode) and over the right buccinator muscle (reference electrode). Stimulation intensity will be set at 1.5 mA. The intensity of the stimulation will be gradually increase in order to reach the 1.5 mA with a ramping-up phase of 15 sec. Similarly, a ramping-down phase of 15 sec will gradually decrease the intensity before the end of the stimulation. The duration of the 1.5mA stimulation will be 20 minutes. Soon after the end of the stimulation, the virtual reality training will be performed. The virtual reality training will took place in a child-friendly scenario. It will comprise a total of 80 trials, during which participants will be asked to compete with some avatars in order to activate and to win some objects.
15818507|NCT04297540|Device|Sham-tDCS group|Sham -tDCS will be delivered over the cerebellum for 8 sessions in two weeks. tDCS will be delivered via a battery driven direct current stimulator. Saline-soaked sponges electrodes will be placed on the cerebellar vermis (anodal electrode) and over the right buccinator muscle (reference electrode). Stimulation intensity will be set at 1.5 mA but the current will be applied for 30 sec. The intensity of the stimulation will be gradually increase in order to reach the 1.5 mA with a ramping-up phase of 15 sec. Similarly, a ramping-down phase of 15 sec will gradually decrease the intensity before the end of the stimulation. The duration of the 0mA stimulation will be 20 minutes. Soon after the end of the stimulation, the virtual reality training will be performed. The virtual reality training will took place in a child-friendly scenario. It will comprise a total of 80 trials, during which participants will be asked to compete with some avatars in order to activate and to win some objects.
15818508|NCT04297527|Procedure|Conventional Physiotherapy|Conventional Physiotherapy consist of Hotpacks, TENS and US.The participants were positioned in prone and supported with a pillow under the abdomen, 20 min hot pack was applied. Therapatic Ultrason were applied with the frequency of 1 MHz, intensity of 1,5 watt/cm² and duration of 5 minute. TENS was applied to the lumbar region with 2-channel, 4 surface electrodes at 60-120 Hz, and 50-100 pulse duration for 20 minutes.
15818509|NCT04297527|Procedure|Mulligan Mobilization|Extension SNAGS in prone, SNAGS in lion position and Lumbar flexion SNAGS in sitting, techniques were used. The techniques were applied in 3 sets with 10 repetitions and 60 seconds rest between sets.
15818510|NCT04297501|Drug|Antiretroviral Therapy|All participants receive antiretroviral therapy to control virus replication and restore CD4+ T-cell count.
15818511|NCT04297488|Dietary Supplement|Bifidobacteria and Lactobacilli triple viable capsules|Bifidobacteria and Lactobacilli triple viable capsules (provided by Shenzhen Wanhe Pharmaceutical Co., Ltd., China) are bilayer minipellets and are resistant to gastric acid. So Bifidobacterium billion Lactobacillus can only be released in intestine. Participants will take 1.27g (contain 3 billion Bifidobacterium and 1 billion Lactobacillus) once daily.
15818512|NCT04297475|Diagnostic Test|Multi-modal photoacoustic/ultrasonic (PA/US) imaging system|The multi-modal PA/US imaging system is equipped with a handheld 3D PA/US probe, and able to provide 3D volume data of dual-wavelength PA imaging of small joints, in addition to real-time 2D PA/US imaging.
15818513|NCT04297462|Drug|Oseltamivir 3 days|Non-inferiority study of 3 versus 7-days duration of PEP
15818514|NCT04297462|Drug|Oseltamivir 7 days|Active comparator
15818515|NCT04297436|Biological|4CMenB (Bexsero®) vaccine|Tthe 4CMenB vaccine (Bexsero®) contains the MeNZB OMV component plus three recombinant antigens (NadA, fHBP-GNA2091, and NHBA-GNA1030. The 4CMenB vaccine (Bexsero®) induces antibodies in humans that recognise gonococcal proteins.
15818516|NCT04297423|Drug|Plenvu|randomization 1:1
15818517|NCT04297410|Radiation|177Lu-PSMA-I&T Radionuclide|Each patient will receive two single doses of 7.4 GBq 177-Lu-PSMA-I&T treatments. The treatments will be given intravenously, 2 weeks apart starting 12 weeks prior to radical prostatectomy.
15818518|NCT04297384|Other|Informational Intervention|Receive standard chemotherapy educational materials
15818519|NCT04297384|Other|Informational Intervention|Receive personalized information about cancer, treatment, and side effects
15818520|NCT04297384|Other|Quality-of-Life Assessment|Ancillary studies
15818521|NCT04297384|Other|Survey Administration|Complete surveys
15818522|NCT04297371|Diagnostic Test|CMR examination|After recruiting participants and collecting the baseline information, a CMR scan and a post-processed imaging procedure will be carried on in order to detect the cardiac impairment.
15818523|NCT04297358|Drug|Hyperbaric oxygen|40 consecutive (5/7) sessions of hyperbaric oxygen
15818524|NCT04297345|Device|Hemodialysis|"Blood enters the extracorporeal circuit from the arterial line of the femoral catheter. For this the investigators use a pump integrated in the monitor, equipped with control systems, exerting a negative pressure.
~Subsequently, it enters the dialyzer through the internal part of the capillaries (porous), producing a passive exchange of inflammatory and oxidative substances (such as cytokines) with the dialysis fluid, which also circulates through the dialyzer, but through the external part of the capillaries. Blood is returned to the patient, through the venous line of the catheter, with a lower concentration of cytokines after passing through the dialyzer.
~This circuit is repeated continuously during the 3 hours of the procedure to ensure maximum clearance of glutamate and interleukins, among other substances."
15818525|NCT04297332|Behavioral|Behavioral Intervention|Complete active episodic thinking task
15818526|NCT04297332|Behavioral|Behavioral Intervention|Complete active future thinking priming task
15818527|NCT04297332|Behavioral|Behavioral Intervention|Complete control episodic future thinking task
15818528|NCT04297332|Behavioral|Behavioral Intervention|Complete control future thinking priming task
15818529|NCT04297332|Other|Informational Intervention|Provided with Forever Free relapse prevention booklet
15818530|NCT04297332|Drug|Nicotine Replacement|Receive nicotine patches, gum, or lozenges
15818531|NCT04297332|Other|Telephone-Based Intervention|Receive coaching call
15818532|NCT04297319|Procedure|Laser diiodo|3 laser diiodo procedures of 5-10 minutes at intervals of 4 weeks It is an outpatient procedure, not anesthesia required.
15818533|NCT04297319|Procedure|Laser Placebo|3 laser diiodo procedures of 5-10 minutes at intervals of 4 weeks. It is an outpatient procedure, not anesthesia required.
15818534|NCT04297306|Behavioral|Exercise Prescription|Standardised Exercise Prescription.
15818575|NCT04296955|Other|Motivational interview as a new health communication intervention|Same as intervention name
15818544|NCT04297215|Device|DermaCura® Chitosan based antimicrobial therapeutic clothing|"DermaCura® antimicrobial therapeutic clothing (D&M) consists of 98% TENCEL® and 2% elastane. 1% chitosan has been added to TENCEL®
~The therapeutic clothing is to be worn at night during the 12-month intervention period and if needed during the day. Usual care including application of emollients, corticosteroid ointments or creams only if needed and/or antihistamines is continued, with standardized steroid ointments and treatment regimens for comparability purposes."
15818545|NCT04297215|Device|Binamed® silver based antimicrobial therapeutic clothing|"The Binamed® antimicrobial therapeutic clothing (BAP Medical) consists of micro-modal, lycra and woven silver filaments as antibacterial agent.
~The therapeutic clothing is to be worn at night during the 12-month intervention period and if needed during the day. Usual care including application of emollients, corticosteroid ointments or creams only if needed and/or antihistamines is continued, with standardized steroid ointments and treatment regimens for comparability purposes."
15818546|NCT04297215|Device|Binamed® therapeutic clothing without antimicrobial agents|"The Binamed® therapeutic clothing without antimicriobial agents (BAP Medical) is therapeutic clothing made of micro-modal and lycra. Micro-madal is a semi-synthetic wood cellulose fiber. This fiber has a high strength hand elasticity, a high moisture-permeability and feels soft. Lycra ensures an optimal fit on the skin.
~The therapeutic clothing is to be worn at night during the 12-month intervention period and if needed during the day. Usual care including application of emollients, corticosteroid ointments or creams only if needed and/or antihistamines is continued, with standardized steroid ointments and treatment regimens for comparability purposes."
15818547|NCT04297202|Drug|Apatinib Combined With SHR-1210 Injection|"3 cycles of neoadjuvant therapy before surgery, two weeks is a treatment cycle: D1、D15、D31 : SHR-1210 200mg, I.V, q2w； D1-D20 : Apatinib 250 mg, orally, qd; D46 : Patients were preoperatively evaluated. Operable patients were scheduled for hepatectomy with/without microwave ablation; After 4 to 8 weeks after liver resection, a postoperative adjuvant program is performed. Three weeks is a treatment cycle with a total of 8 cycles
~In each cycle:
~D1: SHR-1210 200mg, I.V, q3w; D1-D21: Apatinib 250mg, orally, qd;"
15818548|NCT04297189|Behavioral|Coaching and health information intervention|8 session intervention with,group meetings with coaching tools and health information on nutrition and physical activity and coping with stress.
15818549|NCT04297176|Drug|Vancomycin-traditional dosing|The dose is calculated based on 2 vancomycin serum levels
15818550|NCT04297176|Drug|Vancomycin- Trough-only based dosing|The dose is calculated based on 1 vancomycin serum level (i.e. trough)
15818551|NCT04297163|Other|Telemedicine|Remote CPAP monitoring, mobile app and voice mail
15818552|NCT04297163|Other|In Hospital|Face-to-face follow up
15818553|NCT04297150|Drug|Apixaban|Drug indicated for the treatment of NVAF
15818554|NCT04297150|Drug|Edoxaban|Drug indicated for the treatment of NVAF
15818555|NCT04297150|Drug|Rivaroxaban|Drug indicated for the treatment of NVAF
15818556|NCT04297150|Drug|Dabigatran|Drug indicated for the treatment of NVAF
15818557|NCT04297137|Dietary Supplement|Protein ingestion|Ingestion of various sustainable non-animal derived protein sources compared to animal-based milk protein.
15818558|NCT04297124|Drug|CC-90009|0.6 mg [ 14C]-CC-90009 administered IV as a single dose
15818559|NCT04297124|Radiation|[14C]|A single dose of [ 14C]-CC-90009 will contain approximately 2 µCi of radioactivity.
15818560|NCT04297111|Dietary Supplement|Probiotic|GanedenBC30 (Bacillus coagulans GBI-30, 6086) capsule made of 1 billion colony forming units (cfu). Description: pure cell mass of an L-(+) lactic acid-producing, gram-positive, spore-forming shaped bacterium that is aerobic to microaerophilic. Maltodextrin used as filler.
15818561|NCT04297111|Other|Placebo|Maltodextrin capsule, no active ingredient
15818562|NCT04297085|Biological|Biologic sample|Biological samples will be taken from the subjects included
15818563|NCT04297072|Drug|Rivaroxaban (Xarelto, BAY-597939)|Non-vitamin K antagonist oral anticoagulants (NOACs). The prescription of drug is at the discretion of physician following the routine clinical practice.
15818564|NCT04297072|Drug|VKAs|Oral anticoagulant. The prescription of drug is at the discretion of physician following the routine clinical practice.
15818565|NCT04297059|Other|Ajyal Salima|It comprises in class-activities, meetings with parents and improvement of school foodservice
15818566|NCT04297046|Device|PCA (patient controlled analgesia)|Intravenous Patient-Controlled Analgesia was used for postoperative pain control with a bolus dose of 25 mg Tramadol and a lockout interval of 20 min. The pain was evaluated at different times after the operation, both at rest and movement (Dynamic VAS) at the 0., 2., 6., 12. hours and 24h later. All patients received 1 g iv paracetamol 8 hourly intervals regularly. 75 mg im diclofenac sodium was given as rescue analgesic.
15818567|NCT04297033|Drug|Lovastatin|lovastatin 40mg/d 12m
15818568|NCT04297033|Drug|Placebo|placebo
15818569|NCT04297007|Other|PECS block|A dose of ibuprofen 400 mgr and tramodol 100 mg will be performed intraoperatively. Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.
15818570|NCT04297007|Other|Rhomboid intercostal block|A dose of ibuprofen 400 mgr and tramodol 100 mg will be performed intraoperatively. Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.
15818571|NCT04296994|Biological|QL1706|QL1706（PSB205） is a bi-functional product that has been engineered to contain two unique monoclonal antibodies.
15818572|NCT04296981|Other|video-based patient information|explanatory video (8 minutes) concerning communication, stroke issues and stages of the continuum of care
15818573|NCT04296968|Device|Painful stimulation using a laser device (DEKA Stimul 1340, Calenzano, Italy)|In the experimental paradigm, 160 painful stimuli of two intensities (3 J, 3.5 J) will be applied to the dorsum of the left hand using the laser device listed above.
15818574|NCT04296968|Device|Visual cueing|Preceding to each painful stimulus, visual cues (e.g., blue dot and yellow square) will be presented on a screen indicating the intensity of the subsequent stimulus (low and high intensity) with an accuracy of 75%. The contingencies of the visual cues will be explicitly stated to the participants.
15818580|NCT04296929|Other|Complex Decongestive Physiotherapy|Complete decongestive therapy (CDT), also called complex decongestive therapy, is an intensive program that combines many of the different treatment approaches, including bandaging, compression garments, manual lymphatic drainage, exercise, and self care.
15818581|NCT04296916|Drug|IOP lowering eye drops|"Latanoprost 0.005% eye drops will be the first choice. If an IOP reduction of 20% is not achieved within three months, timolol 0.5% will be added as second medication. If an IOP reduction of 20% is then not achieved, alphagan 0.2% or alphagan-P 0.15% will be added. If an IOP reduction of 20% is then not achieved, the individual will be excluded from the study.
~If necessary, latanoprost will be switched to other prostaglandin eye drops, alphagan (or alphagan-P) will be switched to brinzolamide 1% eye drops.
~If necessary, latanoprost and timolol will be switched to Xalacom eye drops, timolol and alphagan will be switched to Combigan eye drops, timolol and brinzolamide will be switched to Azarga eye drops.
~Once daily in the evening for prostaglandin eye drops, and twice daily for other eye drops."
15818582|NCT04296903|Device|MID-C System|Minimal invasive deformity correction system for the treatment of AIS
15818583|NCT04296890|Drug|Mirvetuximab Soravtansine|Mirvetuximab Soravtansine is an antibody drug conjugate designed to target folate receptor α (FRα). It consists of the humanized anti-FRα mAb M9346A attached via a cleavable disulfide linker to the cytotoxic maytansinoid, DM4.
15818584|NCT04296877|Device|Acuvue® Oasys® 2-week Contact Lens|Soft, spherical contact lens used to correct distance vision.
15818585|NCT04296877|Device|Precision1® Daily Disposable Contact Lens|Soft, spherical contact lens used to correct distance vision.
15818586|NCT04296864|Drug|Dupilumab|monoclonal antibody
15818587|NCT04296851|Drug|Niclosamide|The subjects will be randomly assigned in a 2:1 ratio to receive niclosamide or identical-appearing placebo tablets orally for 6 months: niclosamide 650mg once a day in arm 1, placebo once a day in arm 2.
15818588|NCT04296851|Drug|placebo|The subjects will be randomly assigned in a 2:1 ratio to receive niclosamide or identical-appearing placebo tablets orally for 6 months: niclosamide 650mg once a day in arm 1, placebo once a day in arm 2.
15818589|NCT04296838|Drug|intravitreal injection of Conbercept|patients will receive intravitreal injection of Conbercept, and at the same time, aqueous humor sample will be obtained from the anterior chamber to measure the concentrations of cytokines.
15818590|NCT04296825|Dietary Supplement|Camel milk containing Bifidobacterium animalis A6|Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.
15818591|NCT04296825|Dietary Supplement|Camel milk|Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.
15818592|NCT04296825|Dietary Supplement|Bifidobacterium animalis A6|Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.
15818593|NCT04296825|Dietary Supplement|Cow milk|Take the interventions about 30 minutes after meals in the morning and evening for 4 consecutive weeks.
15818594|NCT04296812|Behavioral|Self-Love Model|"The model is a visual illustration shaped as a triangle.
~The bottom left line is title Zero Self-Love, moving upward are characteristics identified from zero self-love along the line.
~The bottom right side is titled Self-Love moving upward are characteristics identified from having self-love.
~At the top of the triangle is a circle with the letter R within for relationship.
~Two small lines project horizontally, from the circle, left and right.
~At the end of the Left line is a circle with the word break-up in the middle, surrounded by terms: drugs, alcohol, self-harming, suicide, and sex as the consequence of zero self-love.
~At the end of right line is a circle with the word break-up in the middle surrounded by terms: support system, coping skills, spirituality reflection as the consequences of having self-love.
~The strategies being discussed:
~Exploring self-esteem strategies.
~Importance of self-worth in relationships.
~Importance of self-awareness."
15818595|NCT04296799|Drug|SMP-100|SAD/MAD
15818596|NCT04296799|Drug|Placebo|Placebo
15818597|NCT04296786|Drug|Sintilimab|200mg intravenously on day 1, every 21 days for 1 cycle, 96 weeks for protocol treatment
15818598|NCT04296786|Drug|Chidamide|20mg po per week continuously
15818599|NCT04296760|Diagnostic Test|Rectal water-contrast transvaginal ultrasonography|Transvaginal ultrasound scan combined with the introduction of saline solution into the rectum
15818600|NCT04296760|Diagnostic Test|Sonovaginography|Transvaginal ultrasound scan combined with the introduction of saline solution into the vagina
15818601|NCT04296747|Drug|induction chemotherapy|Toripalimab 240mg, d1; docetaxel 75mg/m2 d1; cisplatin 75mg/m2 d1, q21d, for 2 cycles
15818602|NCT04296747|Procedure|surgery|After induction chemotherapy, patients with resectable hypopharyngeal cancer would accept surgery within 2-4 weeks and investigator-selected postoperative treatment
15818603|NCT04296747|Radiation|chemoradiotherapy|After induction chemotherapy, patients with unresectable hypopharyngeal cancer who achieved CR/PR/SD in the tumor evaluation according to RECIST1.1 would accept another cycle of chemotherapy, and then radical chemoradiotherapy with cisplatin 100mg/m2, q21d
15818604|NCT04296734|Behavioral|Mothers and Babies|Mothers & Babies (MB) is a program that promotes healthy mood management by teaching pregnant women and new moms how to effectively respond to stress in their lives through increasing the frequency of thoughts and behaviors that lead to positive mood states. Designed as a perinatal depression prevention, the Mothers & Babies targets three specific risk factors: limited social support, lack of pleasant activities, and harmful thought patterns.
15818639|NCT04296422|Drug|NSAIDs or oral contraceptives treatment|Taking NSAIDs or oral contraceptives.NSAIDs include Ibuprofen, Naproxen, Diclofenac, and Piroxicam. Oral contraceptives include Yasmin.
15818719|NCT04295811|Device|EsoGuard (lab assay)|EsoGuard assay (LDT) will be used on cells collected using the EsoCheck (510K cleared esophageal cell collection device)
15818605|NCT04296721|Behavioral|Intensive weigh-loss program|Intervention group: Intensive weight-loss program: 0-3 months very low calorie diet, 15 days substituting three meals for low calorie shakes, from 15 to 120 days substituting 1 meal and from 120 days to 12 months on a low calorie diet while starting a progressive exercise programme. Recommendations for good sleep habits will be given. The program will be carried out through group and individual sessions with the hospital dietician. After 3 months: group sessions with a nurse in the basic area. Group sessions led by hospital dietician. From 3 to 12 months: group sessions led by primary care nurse.
15818606|NCT04296721|Behavioral|Standard Dietary recommendations|Patients will be managed according to the usual recommendations: The common written diet (designed by a hospital nutritionist) and an exercise advice will be given according to patient age and level of activity, without any other assessment or additional visits.
15818607|NCT04296708|Other|Exergame Training|An exergame combines exercise and gaming in a holistic approach.
15818608|NCT04296695|Drug|B/F/TAF|randomized, multicentered, open-lable RCT, one arm with B/F/TAF and one arm with TDF/3TC/EFV
15818609|NCT04296695|Drug|TDF/3TC/EFV|TDF/3TC/EFV
15818610|NCT04296682|Procedure|Alveolar Ridge Preservation With Gingival Graft|Closure of the alveolus with the placement of a free gingival tissue graft removed from the individual palate.
15818611|NCT04296669|Device|Ergotron LearnFit Sit-Stand desk|An adjustable sit-stand desk design for children
15818612|NCT04296656|Behavioral|The 5 S's infant calming intervention|5 simple steps to calm a fussy or crying infant. Steps include swaddling, side position, sound (white noise), swing and suck.
15818613|NCT04296643|Device|Medical Mask|Medical Mask (known also as Surgical Mask)
15818614|NCT04296643|Device|N95 respirator|N95 respirator
15818615|NCT04296630|Other|Social media message #1|Social media message promoting colorectal cancer screening
15818616|NCT04296630|Other|Social media message #2|A different social media message promoting colorectal cancer screening
15818617|NCT04296630|Other|Social media message #3|A different social media message promoting colorectal cancer screening
15818618|NCT04296630|Other|Tailored social media messages|Tailored social media messages promoting colorectal cancer screening.
15818619|NCT04296617|Other|Medical Chart Review|Review of medical chart
15818620|NCT04296604|Device|Transcranial Direct Current Stimulation|In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
15818621|NCT04296591|Diagnostic Test|fetal heart doppler findings|Doppler data of main pulmonary artery and right pulmonary artery, mitral valve e/a wave ratio and lamellar body count were determined as the main research parameters. In both groups, fetal thorax and heart circumference ratio, mitral e/a wave ratio, right pulmonary artery and main pulmonary doppler indexes (PI, RI, S / D, AT / ET) were evaluated before cesarean section.
15818622|NCT04296578|Drug|Abiraterone Acetate|Standard of Care (SOC) abiraterone (Zytiga) as per package insert. The recommended dose of ZYTIGA is 1,000 mg (four 250 mg tablets) administered orally once daily in combination with prednisone 5 mg administered orally twice daily.
15818623|NCT04296578|Drug|Sodium Selenite|11 mg tablets
15818624|NCT04296578|Drug|Prednisone|SOC prednisone 5 mg PO twice daily
15818625|NCT04296565|Behavioral|Usual Care|Usual Care condition involves receipt of educational materials about brain health and healthy lifestyles as well as regular contact with study staff
15818626|NCT04296565|Behavioral|WATER+CT|This is an 8 month long two phase intervention. The first phase consists of 6 months of thrice weekly pool based physical activity occurring at the Palo Alto VA Health Care System. After completion of the 6 month long water based physical activity, participants transition to a ten session cognitive training program at the Palo Alto VA. The cognitive training classes are approximately two hours in length and will be spread over ten sessions across 4 weeks.
15818627|NCT04296552|Other|Dietary lowFODMAP intervention|Twelve week strict lowFODMAP dietary intervention, involving restricted intake of fermentable carbohydrates (FODMAPs).
15818628|NCT04296526|Behavioral|Exercise Prescription|To prescribe exercise programs that can be easily applied at home/dormitory/living place for students.
15818629|NCT04296526|Behavioral|Exercise Education|To organize sessions for how to proper exercise.
15818630|NCT04296526|Behavioral|Social Support|Supports such as peer influence or reminder phone messages
15818631|NCT04296513|Diagnostic Test|High-Definition white light endoscopy.|evaluation of the gastric mucosa with high-definition white light endoscopy (EG-29i10 gastroscope and EPKi7010 video processor). The endoscopy images will be seen on a 27inch, flat panel, high definition LCD monitor (Radiance™ ultraSC-WU27-G1520 model) by
15818632|NCT04296513|Diagnostic Test|High-definition magnification with digital chromoendoscopy.|Subject will be evaluated by upper endoscopy with the OE System (EPK-i7010 HD Video Processor and MagniView™ EG-2990Zi Video Gastroscope) with intravenous sedation in a standardized manner. This technique involves the use of a distal black rubber hood (OE-A58; Pentax) at the tip of the endoscope, to fix the distance between the tip of the endoscope and the gastric mucosa at 2 mm. The OE System will be used in mode 1 and mode 2 without optical magnification, to obtain an overview of the gastric body and identify any gross changes in the mucosa, then optical magnification will be implemented.
15818633|NCT04296500|Other|Decision tree modeling|"A decision tree analysis was employed to explore the process of decision-making on types of pattern based on the existence or nonexistence of a symptom. At the end of tree presented is the proportion of patients who are categorised into each pattern.
~In this study, the classification was performed by applying the classification and regression tree (CART) algorithm using Scikit-learn package of Python, which performs a division using the Gini coefficient or the decrement of dispersion. The Gini coefficient is one of the tools for measuring entropy or diversity in each node and it measures the decrement by comparing the information entropy before and after separation. To avoid overfitting, the maximum number of leaf nodes was limited to four and the pruning method which complied with the principle of minimum description length was applied."
15818634|NCT04296487|Other|autologous chondrocytes|autologous chondrocytes implantation (ACI)
15818635|NCT04296474|Drug|ALK Alutard 5-grasses and birch|Intralymphatic injections
15818636|NCT04296474|Drug|ALK Diluent|intralymphatic injections
15818637|NCT04296461|Genetic|Welgenaleucel|Welgenaleucel (UWC19) is a CD19-directed immunotherapy consisting of autologous T cells, which is reprogrammed to target cells that express CD19.
15818638|NCT04296448|Device|Cellscope|Cellphone otoscope (Cellscope) to evaluate pediatric patient ears.
15818640|NCT04296422|Device|Low dose acupuncture|Six acupoints: Three Yin Intersection( SP6)、Grandfather Grandson(SP4)、 Sea of Blood(SP10) 、Sea of Qi(RN6)、Origin Pass(RN4) 、Inner Pass(PC6)
15818641|NCT04296422|Device|High dose acupuncture|Twelve acupoints: Three Yin Intersection( SP6)、Grandfather Grandson(SP4)、 Sea of Blood(SP10) 、Sea of Qi(RN6)、Origin Pass(RN4) 、Middle Extremity(RN3)、Inner
15818642|NCT04296409|Other|Turkish Deglutition Handicap Index|Swallowing function will be evaluated by the Turkish Deglutition Handicap Index.
15818643|NCT04296396|Drug|0 to 20 tablets of oxycodone 5mg|Individualized opioid prescription protocol (IOPP) that includes shared decision making
15818644|NCT04296396|Drug|Fixed opioid prescription|20 tablets of oxycodone 5mg
15818645|NCT04296383|Drug|Azithromycin plus Xiyanping injection|Azithromycin for injection is 10mg / (kg • d), the maximum dose does not exceed 0.5g / d;Xiyanping injection intravenously, 0.4mL / (kg.d) daily, Qd
15818646|NCT04296383|Drug|Azithromycin|Azithromycin for injection is 10mg / (kg • d), the maximum dose does not exceed 0.5g / d
15818647|NCT04296370|Drug|Fluzoparib; Apatinib|Fluzoparib Orally twice daily; Apatinib Orally once daily
15818648|NCT04296370|Drug|Fluzoparib|Fluzoparib Orally twice daily
15818649|NCT04296370|Drug|Physician's choice chemotherapy|"Investigators will declare one of the following regimens:
~Capecitabine Vinorelbine"
15818650|NCT04296357|Diagnostic Test|Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3|Ages & Stages Questionnaires®, Third Edition (ASQ®-3) is a developmental screening tool designed for use by early educators and health care professionals. It relies on parents as experts, is easy-to-use, family-friendly and creates the snapshot needed to catch delays and celebrate milestones.
15818651|NCT04296357|Other|Physical development and General Health|Physical development and General health examination
15818652|NCT04296357|Diagnostic Test|Developmental Red flags|Developmental Red flags Questionnaires
15818653|NCT04296344|Other|Acupuncture Therapy Treatments|10 consecutive weekly group acupuncture therapy treatments
15818654|NCT04296344|Other|Yoga Therapy Sessions|8 consecutive yoga therapy sessions that occur immediately following in a room adjacent to acupuncture therapy.
15818655|NCT04296331|Diagnostic Test|POC|DC DOC's current testing practice offers opt-out POC testing with the INSTI® finger stick test at entry
15818656|NCT04296331|Diagnostic Test|Ag/Ab|The DC DOC will transition from offering their current POC testing upon entry to offering opt-out HIV testing with Ag/Ab: ARCHITECT® laboratory-based test.
15818657|NCT04296331|Diagnostic Test|POC + Ag/Ab|As the DC DOC transitions to utilizing the Ag/Ab: ARCHITECT® laboratory-based test from their current POC testing, jail nurses will offer new entrants op-out testing with the two methods
15818658|NCT04296305|Drug|Hydromorphone|Given IV after
15818659|NCT04296305|Drug|Placebo Administration|Given IV after
15818660|NCT04296305|Other|Questionnaire Administration|Ancillary studies
15818661|NCT04296292|Other|In-depth interviews|In-depth interviews following a narrative line of enquiry and direct observation at each of the research sites
15818662|NCT04296279|Drug|FMP014|Falciparum Malaria Protein-14
15818663|NCT04296279|Drug|ALFQ|ALF with QS-21, saponin molecule derived from the tree bark of Quillaja species
15818664|NCT04296266|Drug|Alda-341|Dietary supplement d-limonene orally administered as a drug.
15818665|NCT04296253|Genetic|SNP polymorphisms of the promoter regions pro - and anti-inflammatory cytokines and angiogenic growth factor|blood sampling
15818666|NCT04296240|Drug|Oxaliplatin and capecitabine|Patients receive 5-Fu and oxaliplatin based neoadjuvant chemotherapy for 3 months
15818667|NCT04296240|Procedure|Total Mesorectal Excision|Patient receive total mesorectal excision after neoadjuvant chemotherapy
15818668|NCT04296227|Device|The Vital Detect blood pressure monitor|The end goal is to provide Non-invasive Blood Pressure (NIBP) accuracy data to support validation of the Vital Detect blood pressure monitor.
15818669|NCT04296214|Drug|5-azacitidine|Cycles of 28 days
15818670|NCT04296201|Device|DMA treatment|Each arm will receive the DMA treatment in a specific area on the body to observe immediate effect.
15818671|NCT04296188|Procedure|serratus anterior plane block|ultrasound guided serratus anterior plane block will be done with % 0.25 bupivacaine.
15818672|NCT04296188|Procedure|erector spina plane block|ultrasound guided erector spina plane block will be done with % 0.25 bupivacaine.
15818673|NCT04296175|Drug|Epirubicin|90mg/m2, d1 every 2 or 3 weeks
15818674|NCT04296175|Drug|CTX|600mg, d1 every 2 or 3 weeks
15818675|NCT04296175|Drug|Paclitaxel|80mg/m2,d1,d8,d15, every 3 weeks
15818676|NCT04296175|Drug|ddEpirubicin|90mg/m2, d1 every 2 weeks
15818677|NCT04296175|Drug|ddCTX|600mg, d1 every 2 weeks
15818678|NCT04296175|Drug|Paclitaxel(with carbo)|80mg/m2,d1,d8,d15, every 4 weeks
15818679|NCT04296175|Drug|Carboplatin|AUC=2,d1,d8,d15, every 4 weeks
15818680|NCT04296162|Drug|Vinorelbine|Vinorelbine chemotherapy (oral)
15818681|NCT04296162|Drug|Capecitabine|Capecitabine chemotherapy (oral)
15818682|NCT04296162|Drug|Trastuzumab|Trastuzumab target therapy
15818683|NCT04296149|Drug|Y90-DOTA-Tyr3-Octreotide|Patients enrolled for surgery will receive a small amount of Y-90-DOTATOC, in order to check beta- radioactivity by the probe
15818685|NCT04296123|Behavioral|Step training|A 12-week step training consisting of two 30-minute training session per week. The participants will be instructed to stand upright and step on different targets on a plastic mat repeatedly.
15818715|NCT04295850|Drug|Aspirin 81 mg|Aspirin 81mg daily PO
15818716|NCT04295837|Other|ABLE|Home-based occupational therapy compensatory programme addressing activities of daily living
15818717|NCT04295837|Other|Usual Care|Standard occupational therapy
15818718|NCT04295824|Diagnostic Test|Skin imaging and Skin biopsy|"Imaging includes:
~Structural Optical Coherence Tomography (OCT) - Skin thickness/roughness.
~Angiographic OCT- Vessel depth/morphology.
~Polarisation-sensitive OCT - Tissue birefringence / collagen index.
~Skin biopsies will be taken from the same volar forearm site as the imaging is performed."
15818686|NCT04296110|Behavioral|Biofeedback|They will also be taught how to use the biofeedback app and Inner Balance device. Additionally, they will also be educated on the principles of biofeedback and its benefits and taught how to maximize HRV by using self-regulation breathing techniques.They will be given an Inner Balance device, which is an ear sensor that connects to an apple device that measures heart rate variability (HRV) and gives them access to an app that is designed to help them improve their HRV. They will be asked to practice breathing at their resonance frequency using the Inner Balance device daily for 5-15 mins for the duration of the 12-week intervention. Patients and the research coordinator will have access to all of their sessions and results. The research coordinator will monitor compliance via the Heartcloud associated with their device and encourage adherence throughout the intervention.
15818687|NCT04296110|Other|Music Relaxation Therapy|We will determine what genre of music is most relaxing to them and ask them to listen to this type of music using the spotify app for 5-15 mins a day for 12 weeks. If they do not have access to a device that they can listen to spotify on, an ipod will be provided. They will be asked to complete a 2-question survey via Redcap daily that asks them if they have listened to the designated music that day and for how long.
15818688|NCT04296097|Device|DBS|Deep Brain Stimulation (DBS) of the parieto-insular region at the level of the right operculum 3 (OP3)
15818689|NCT04296071|Other|Research study|Blood and tracheal aspirates will be collected
15818690|NCT04296058|Other|microvessel density|the vessel numbers in high power field with Anti-CD31 staining in tumor specimen
15818691|NCT04296045|Dietary Supplement|MCE|MCE
15818692|NCT04296045|Dietary Supplement|Glucose|Glucose
15818693|NCT04296032|Behavioral|virtual reality game traning|The controllers were attached to upper extremity to control the game. The game could train the shoulder, elbow, and wrist control.
15818694|NCT04296032|Behavioral|standard treatment|The program included bilateral hand, grasp/release, and pinch activities.
15818695|NCT04296019|Drug|Fruquintinib|Maintenance therapy with fruquintinib ( 5 mg qd for 3 consecutive weeks, followed by discontinuation for 1 week).
15818696|NCT04296006|Drug|Sustained Release d-amphetamine|Twice daily administration of active or placebo d-amphetamine
15818697|NCT04296006|Behavioral|Money|Three money values offered as alternatives to cocaine
15818698|NCT04295993|Drug|Methylene Blue|The patient will receive Methylene Blue bolus with a dose of 2 mg/kg over 10 minutes.
15818699|NCT04295993|Drug|Norepinephrine infusion|The patient will receive norepinephrine infusion to maintain mean arterial pressure above 65 mmHg
15818700|NCT04295980|Procedure|Surgical removal of the BAVMs|Resection the BAVM nidus by microsurgery.
15818701|NCT04295967|Other|formalin fixed paraffin embedded blocks|The study will be conducted using formalin fixed paraffin embedded blocks of seventy cases of urothelial carcinomas .CD31-PAS dual-staining will be performed to confirm the presence of VM.
15818702|NCT04295954|Other|Yoga Intervention|"It is an intervention based on Hatha yoga designed specifically to improve dysmenorrhea. This intervention consists of physical postures, also called asanas; meditation and breathing. It begins with a progression of various asanas until reaching the three central postures: cat, cobra and fish. The compensation asanas of these central postures are then performed, and it is closed with a relaxation. The program and Yoga Intervention have been triangulated by experts and piloted afterwards."
15818704|NCT04295928|Behavioral|PPP|Personalized Pharmaceutical Plan on therapeutic adherence to immunosuppressive treatments after the transplantation
15818705|NCT04295915|Device|Specimens that meet inclusion criteria|Specimens that have been de-identified and considered remnant by the laboratory (fresh specimens) or were contrived by the laboratory (using bacterial isolates with no identifying information) can be enrolled into the study.
15818708|NCT04295889|Diagnostic Test|Approach A (PeeSpot urine collection device).|The participant will receive the PeeSpot urine collection device (Hessels+Grob B.V., Deventer, The Netherlands), which consists of a holder containing a urine collection pad (consisting of hygroscopic material containing). The holder can be placed back into the tube and can be easily sent to the laboratory by mail. In this urine, albumin, creatinine, and the ACR will be measured in the laboratory of the Amphia hospital.
15818709|NCT04295889|Diagnostic Test|"Approach B (ACR | EU Test kit)."|"The participant will receive the ACR | EU test kit (Healthy.io Ltd, Tel-Aviv- Yafo, Israel), which consists of a urine test strip, a urine cup, a color calibrator and instruction to download a smartphone application. The participants have to download the smartphone application according to the instructions included in the kit. Results will be directly shown to the participant in the app."
15818710|NCT04295876|Behavioral|The BRIDGES Project Intervention|The BRIDGES Project will use Peer Navigators, who are other women living with HIV who have had similar experiences and have been successful in accessing care, to help other women living with HIV to access HIV care and stay in HIV care. The BRIDGES Project will also provide support to women through group sessions co-facilitated by a licensed clinical therapist and Peer Navigator. Through participation in BRIDGES, women will: (1) build skills to cope with HIV care and treatment barriers (e.g., violence, trauma, adverse mental health, substance use); (2) be connected to HIV treatment and other support services (e.g., domestic violence, mental health, substance use); and (3) learn interpersonal skills to connect with support (e.g., service providers, peers, friends, family) when faced with new or ongoing barriers.
15818711|NCT04295863|Drug|Nivolumab Standard|For patients on standard schedule dosing of nivolumab, therapy will consist of 240mg IV once every 2 weeks or 480mg IV once every 4 weeks
15818712|NCT04295863|Drug|Pembrolizumab Standard|For patients on standard schedule dosing of pembrolizumab, therapy will consist of 200mg IV once every 3 weeks or 400mg IV once every 6 weeks
15818713|NCT04295863|Drug|Nivolumab Extended|For patients on extended interval dosing of nivolumab therapy will consist of 240mg IV once every 4 weeks or 480mg IV once every 8 weeks
15818714|NCT04295863|Drug|Pembrolizumab Extended|For patients on extended interval dosing of pembrolizumab therapy will consist of 200mg IV once every 6 weeks
15818720|NCT04295811|Diagnostic Test|Esophagogastroduodenoscopy|Planned EGD to diagnose and/or treat disorders of esophagus, stomach, and small intestine. When abnormal tissues are noted, biopsies of the tissue are taken through the scope to diagnose tissue abnormalities.
15818721|NCT04295798|Other|Traditional tDCS|The participant will receive a single-session of traditional tDCS for 20 minutes.
15818722|NCT04295798|Other|Traditional Sham|The participant will receive a single-session of traditional sham for 20 minutes.
15818723|NCT04295798|Other|Personalized tDCS|The participant will receive a single-session of personalized tDCS for 20 minutes.
15818724|NCT04295798|Other|Personalized Sham|The participant will receive a single-session of personalized sham for 20 minutes.
15818725|NCT04295772|Drug|DOR/ISL|100 mg DOR/0.75 mg ISL FDC tablet taken once daily by mouth.
15818726|NCT04295759|Drug|INCB7839|INCB7839 dosing will begin at 120 mg/m2/dose BID which is equivalent to the adult RP2D (200 mg PO BID) based on a typical adult size of 1.67m2. The INCB7839 dose may be decreased to 80 mg/m2/dose BID if the staring dose is not tolerable. 28 consecutive days (4 weeks) will constitute one course. Patients may continue to receive INCB7839 for 26 courses (approximately 2 years).
15818727|NCT04295746|Other|Serious Game ShopAut|"The serious game ShopAut, is a three-dimensional game conceptually based on classic 3D life simulation games. ShopAut aims to teach players the procedure of a shopping activity; to reinforce object categorization and recognition in a supermarket; to improve attention, orientation, and problem-solving skills; and to help the player engage in simple economic transactions.
~The intervention provides a virtual training with ShopAut to train, experiment, and practice behaviours and actions that can be then transferred in real-life contexts."
15818728|NCT04295733|Biological|4CMenB (Bexsero®) vaccine|Participants will receive 2 doses of 4CMenB (Bexsero®) vaccine administered intramuscularly 1-2 months apart
15818729|NCT04295720|Device|Transcranial magnetic stimulation (TMS)|"Subjects will undergo testing at baseline prior to TMS treatments and once more at the end of the 2-week intervention.After the conclusion of baseline data acquisition, the research team will analyze each participant's unique structural and functional connectivity patterns to determine stimulation site for TMS in future study sessions.
~The subjects will receive 10-sessions (1 session per day, M-F over 2 consecutive weeks).
~The treatment itself lasts approximately only 190 seconds."
15818730|NCT04295707|Device|orthokeratology|Nightly wear of orthokeratology lenses to correct vision in the daytime
15818731|NCT04295707|Device|Menicon Progent A+B|Menicon Progent A+B is a commercially available protein remover for rigid lenses. It has received FDA clearance and been launched in Hong Kong for over a decade. The product contains two separate sterile solutions, one with sodium hypochlorite and the other with potassium bromide. By mixing the two solutions in a special vial, it can clean and remove protein deposits on the lenses. Parents of subjects assigned to use weekly protein remover will be required to soak the cleansed lenses in the solution mixture for not more than 30 mins every week. All lenses must be rinsed thoroughly with saline and cleansed with daily cleaner again before daily disinfection.
15818732|NCT04295681|Drug|MMH-MAP|Oral administration.
15818733|NCT04295681|Drug|Placebo|Oral administration.
15818734|NCT04295668|Behavioral|Usual care|The preoperative standard measures consist of physical activity recommendation and advice on both smoking cessation and alcohol intake reduction. Moreover, in patients presenting with anemia, the anesthesiologists will assess its etiology and treat it accordingly, and nutritional intervention will be performed by a registered dietitian in to those patients at risk of malnutrition (Malnutrition Universal Screening Tool ≥2).
15818735|NCT04295668|Behavioral|Prehabilitation|"i) Exercise training: Ambulatory exercise training sessions with two main components, namely: high-intensity endurance exercise training and strength muscular training.
~ii) Promotion of physical activity: Pedometer-based program using a physical activity tracker linked to a mobile app.
~iv) Nutritional optimization: Recommendations of a healthy balanced diet or adapted to their digestive symptoms. Daily amount of protein intake will be close to 2 g•Kg-1•day-1.
~iv) Smoking cessation: Use of both cognitive behavioral intervention and pharmacological therapy by varenicline or nicotine replacement therapies.
~v) Cognitive behavioral therapy: Weekly group sessions conducted by a clinical health psychologist, including psychoeducation, motivational and behavioral change, self-efficacy and adherence enhancement, coping strategies acquisition and patient empowerment."
15818736|NCT04295655|Other|Global Exercise intervention|The program included 15 minutes of deep breathing exercises and 20-30 minutes of limb exercises. The exercises included global active range of motion (ROM) exercises and muscle strengthening like upper and lower limbs flexion-extension do single-leg stance, and sit to stand exercises
15818737|NCT04295655|Other|Functional Electrostimulation Group|"The program included a neuromuscular stimulation therapy on quadriceps accompanied by lower limb exercises. The intervention was performed following the protocol described by Valenza et al (2017).
~Valenza MC, Torres-Sánchez I, López-López L, Cabrera-Martos I, Ortiz-Rubio A, Valenza-Demet G. Effects of home-based neuromuscular electrical stimulation in severe chronic obstructive pulmonary disease patients: a randomized controlled clinical trial. Eur J Phys Rehabil Med. 2018 Jun;54(3):323-332. doi: 10.23736/S1973-9087.17.04745-1. Epub 2017 Nov 16. PubMed PMID: 29144103."
15818738|NCT04295655|Other|Standard treatment|Patients received standard medical and pharmacological care that consisted in systemic steroids, inhaled bronchodilators, oxygen, and a regimen of oral prednisone or its equivalent in doses of 40 to 60 mg per day for the duration of therapy as well as anti-biotic therapy
15818739|NCT04295642|Drug|CVL-751|Oral tablet
15818740|NCT04295629|Procedure|Research on the effects of Ilioinguinal Nerve Block on Chronic Pain in Patients who undergo Inguinal Hernia with Spinal Anesthesia|The patients underwent inguinal hernia operation randomly classified into two groups in the operating room as; Group I (n:30); spinal block (SA): All patients were given SA in sitting position and 3ml 0.5% hyperbaric bupivacaine was injected in sterile conditions with 25 G injection in L3-4, L4-5 subarachnoid space. Times when the block reached T10 level were recorded.
15818741|NCT04295629|Procedure|Ilioinguinal nerve block|Group 2 (n:30); SA in sitting position and 3ml 0.5% hyperbaric bupivacaine was injected in sterile conditions with 25 G injection in L3-4, L4-5 subarachnoid space and as a ilioinguinal block (IHNB) 10 ml 5% bupivacaine was injected to patients with peripheric nerve block injection in the reanimation unit after the surgery.
15818851|NCT04294615|Other|FMT through a naso-jejunal tube|Prepared feces by automatic methods, then the purified fecal microbiota was delivered into the intestine through a naso-jejunal tube.
15818742|NCT04295616|Device|Intrapulmonary percussive ventilation (IPV)|"IPV is a well-tolerated method to pump air jets into the lungs via a mouth mask at frequencies of 100-400 pulses per minute.
~Each IPV session lasts 15 minutes, whereby the person with MS is firstly administered with a mask for 3 minutes at a high frequency (250 to 400 cycles per minute) and then 12 minutes with a low frequency (75 to 150 cycles per minute). The pressure (1.1 - 1.4 bar) is adjusted so that it is comfortable for every participant, yet there is the maximum possible expansion of the thorax. The sessions are given by speech therapists who are familiar with IPV. The IPV treatment will be provided 5 days a week, during 3 or 4 weeks."
15818743|NCT04295616|Behavioral|Active breathing training|The active breathing exercises are based on the flow-based incentive spirometer (Inspirix). The Inspirix is a device consisting of a tube with a ball. A plastic tube is connected to the device with a mouthpiece in which the person with MS will has to breathe in and out. The device is equipped with a control button to build up the resistance (number of cc / sec). The aim is to train the inspiratory and expiratory volume as well as the inspiratory and expiratory exhalation force. These exercises are offered 5 times a week in groups under the supervision of an experienced speech therapist, during 3 or 4 weeks.
15818744|NCT04295603|Other|Toucher Massage (TM) on the feet|The intervention for the Experimental Group (EG) includes a massage time of about 15 minutes (according to current Geneva Hospital practice) on the foot area. At least four sessions will be delivered and spread over two weeks. The TM will be provided by the care team. The training time for the workers corresponds to 2 times 2 hours. In order to be as close as possible to a standardized session, practitioners will benefit from an intervention guide.
15818745|NCT04295603|Other|Homedics HM MP RELEX 90 device|"The Control Group (CG) will benefit from an intervention of identical duration. The treatment consists of a foot massage with a Homedics HM MP RELEX 90 device, a heat-free shiatsu program, which lasts about 15 minutes. The use of the Homedics device is no more a common treatment than the practice of Touch-Massage. TM involves a therapeutic relationship between caregiver and patient. It is for this reason that we need a comparator that should allow us to keep the aspect of the massage while decreasing the aspect of the therapeutic relationship and therefore offer us an adequate comparator."
15818746|NCT04295590|Behavioral|Frequency comparison|One leg assigned to low-frequency low-intensity (3 days per week of 11 x 1 min @ 73% peak work rate interspersed with 1-minute periods of active recovery). The other leg assigned to high-frequency low-intensity (5 days per week of 11 x 1 min @ 73% peak work rate interspersed with 1-minute periods of active recovery).
15818747|NCT04295590|Behavioral|Intensity comparison|One leg assigned to low-frequency low-intensity (3 days per week of 11 x 1 min @ 73% peak work rate interspersed with 1-minute periods of active recovery). The other leg assigned to low-frequency high-intensity (3 days per week of 8 x 1 min @ 100% peak work rate interspersed with 1-minute periods of active recovery).
15818748|NCT04295577|Other|Niraparib|Niraparib - Niraparib is an oral, highly selective PARP-1 and -2 inhibitor. However, it also inhibits other members of the PARP family, including PARP 3, -4, -10, 12, -14, and -15[13].
15818749|NCT04295564|Other|Additional 2 weeks of CPAP|Subjects will be randomized to an additional 2 weeks of CPAP vs. discontinuing CPAP per usual care.
15818750|NCT04295551|Drug|Lopinavir / ritonavir tablets combined with Xiyanping injection|Xiyanping injection, 10-20ml daily, Qd, the maximum daily does not exceed 500mg (20mL) + Lopinavir tablet or Ritonavir tablet+Alpha-interferon nebulization, for 7-14 days,
15818751|NCT04295551|Drug|Lopinavir/ritonavir treatment|Lopinavir / ritonavir tablets, 2 times a day, 2 tablets at a time; alpha-interferon nebulization
15818754|NCT04295525|Dietary Supplement|400 mg mucoadhesive oral tablet|AqualiefTM (Metis Healthcare s.r.l., Milano, Italy)
15818755|NCT04295525|Dietary Supplement|placebo mucoadhesive oral tablet|placebo
15818756|NCT04295512|Behavioral|Unstuck and on Target (UOT)|Unstuck and on Target (UOT) is a cognitive-behavioral treatment that directly addresses executive functioning and self-regulation deficits in ASD and ADHD. UOT is the first contextually-based executive functioning treatment that targets flexibility, goal-setting and planning through a cognitive behavioral program centered on self-regulatory scripts that are consistently modeled and reinforced. UOT will be adapted for use in mental health service settings. Mental health therapists will be trained in UOT and deliver to youth and caregivers.
15818757|NCT04295486|Drug|Aspirin|Non-enteric coated 81 mg Aspirin tablet.
15818758|NCT04295473|Procedure|Reduced port laparoscopic gastrectomy|The ports were reduced in the surgery of intervention arm.
15818759|NCT04295460|Drug|Randomize|Randomize to naive-treatment HIV-infected patients to receive dual o triple therapy as initial antiretroviral treatment
15818760|NCT04295447|Other|Standard of care|"Observation only or
~An optional adjuvant radiation of the prostate bed in case of positive surgical margin"
15818761|NCT04295447|Drug|Apalutamide 60Mg Tab|(4 x 60 mg) once daily on days 1-28 of a 28-day cycle
15818762|NCT04295421|Procedure|adductor canal block|ACB was done in the immediate postoperative period under a high-frequency ultrasound guidance in which the adductor canal was identified beneath the sartorius muscle and 20 ml of 0.2% ropivacaine was injected in the canal using a 22-gauge 100-mm short-beveled regional block needle and a catheter was kept for 48H with 4 ml/h ropivacaine 0.2%.
15818763|NCT04295421|Procedure|IPACK block|IPACK block was realized after spinal anesthesia with 40 ml 0.2% ropivacaine and at the end of surgery , patients were given ACB with 20 ml 0.2% ropivacaine and continued with 4 ml/H saline for 48H
15818764|NCT04295408|Procedure|Pericapsular nerve group block with saline solution|A curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 100-mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the saline solution was injected in 5-mL increments while observing for adequate fluid spread in this plane.a total volune of 40 ml saline solution was injected.
15818852|NCT04294615|Other|FMT through TET|Prepared feces by automatic methods, then the purified fecal microbiota was delivered into the intestine through a transendoscopic enteral tubing (TET) which is fixed to the cecum with clips under endoscopic guidance.
15818765|NCT04295408|Procedure|Pericapsular nerve group block with ropivacaine|A curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees. In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 100-mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, local anesthetic was injected in 5-mL increments while observing for adequate fluid spread in this plane. a 2 mg.kg-1Ropivacaine in 40 ml of saline was injected
15818766|NCT04295395|Device|NONIN SenSmart model X-100 near- infrared spectrometer|for to measure cerebral (cSO2) and renal (rSO2 ) regional tissue oxygen saturation on the day after echocardiography was done. The sensors were placed on the right/left forehead and the right/left lateral posterior flank
15818767|NCT04295382|Device|Software Application|A software application targeting suicidal ideation via interactive exercises.
15818768|NCT04295369|Behavioral|Lifestyle Medicine|Lifestyle intervention with components including physical activity, diet, relaxation/mindfulness, sleep, stress management, and Chinese dietary recommendations.
15818769|NCT04295356|Biological|CT-P17|subjects will receive a single dose (40 mg) of CT-P17 via AI on Day 1 followed by 10 weeks
15818770|NCT04295356|Biological|CT-P17|subjects will receive a single dose (40 mg) of CT-P17 via PFS on Day 1 followed by 10 weeks
15818771|NCT04295343|Diagnostic Test|Three-dimensional (3D) rectal water contrast transvaginal ultrasonography|Rectal water contrast transvaginal ultrasonography is based on the distention of rectosigmoid with saline solution. Three-dimensional reconstructions convert standard 2D grayscale ultrasound acquisitions into a volumetric dataset.
15818772|NCT04295343|Diagnostic Test|Computed colonography|Computed colonography or virtual colonoscopy uses special x-ray equipment to examine the large intestine. During the exam, a small tube is inserted a short distance into the rectum to allow for inflation with gas while computed tomographic images of the colon and the rectum are taken.
15818773|NCT04295330|Drug|Lidocaine Hydrochloride, Injectable|In the lidocaine group, at the end of the induction of general anesthesia, a bolus injection of lidocaine 1.5 mg/kg, calculated using the patient's ideal body weight and given as an infusion over 10 minutes, followed by a continuous infusion of lidocaine at 1.5 mg/kg per hour for the whole surgical procedure and will be discontinued at the end of surgery. Postoperative pain management during the first 72 postoperative hours will involve the use of a PCIA device, which will contain lidocaine 30mg/kg, sufentanil 2 μg/kg, granisetron 12 mg diluted to 200 mL in 0.9 % normal saline.
15818774|NCT04295330|Drug|0.9% normal saline|In the placebo group, the same volume of normal saline will be administered during anesthesia. The postoperative PCIA device will contain sufentanil 2 μg/kg, granisetron 12 mg diluted to 200 mL in 0.9% normal saline solution with a total volume of 200 ml.
15818775|NCT04295317|Drug|PD-1 blocking antibody SHR-1210|PD1 antibody SHR-1210 D1 200 mg every three weeks; Three weeks is a course of treatment with a total of 8 courses, or the patient has tumor recurrence or metastasis (requires imaging to determine tumor recurrence or metastasis)
15818776|NCT04295317|Drug|Capecitabine|Capecitabine 2500mg / m2/ d, 2 times/d for 2 weeks, followed by 1 week of stopping ,Three weeks is a course of treatment with a total of 8 courses, or the patient has tumor recurrence or metastasis (requires imaging to determine tumor recurrence or metastasis)
15818777|NCT04295304|Device|Retinal surgery with implantation of epi-retinal device|Retinal surgery and implantation of epi-retinal prosthesis
15818778|NCT04295278|Diagnostic Test|MicroKine Dx system|Biomarker concentrations will be determined using the MicroKine Dx system and results will be compared to measurements taken using standard immunoassays.
15818779|NCT04295265|Device|smartphone message|Receive daily whatsapp/ SMS message to remind the drug intake
15818780|NCT04295239|Procedure|MRI|Pre and Post operative MRI
15818781|NCT04295226|Other|Structured follow-up after stroke.|Stroke-nurse managed follow-up 3 and 12 months after stroke and multidisciplinary rounds resulting in individual treatment plans for stroke-related health problems.
15818782|NCT04295213|Other|oligosaccharides|1 dose a day of oligosaccharides or placebo
15818783|NCT04295200|Other|Dry needling with electrical stimulation|Paravertebral dry needling to L3, 4, 5 multifidi. Electrical stimulation will be applied through the needles for up to 10 minutes total or to the participant's tolerance.
15818784|NCT04295187|Other|Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3|Ages & Stages Questionnaires®, Third Edition (ASQ®-3) is a developmental screening tool designed for use by early educators and health care professionals. It relies on parents as experts, is easy-to-use, family-friendly and creates the snapshot needed to catch delays and celebrate milestones.
15818785|NCT04295187|Other|Physical development and General Health|Physical development and General health examination
15818786|NCT04295187|Other|Developmental Red flags|Developmental Red flags Questionnaires
15818787|NCT04295161|Drug|Abiraterone Acetate|Abiraterone acetate immediate release formulations
15818788|NCT04295148|Procedure|ACL Reconstruction with Semitendinosus graft|Participants will undergo Anterior Cruciate Ligament Reconstruction with Semitendinosus graft
15818789|NCT04295148|Procedure|ACL Reconstruction with Quadriceps tendon-bone graft|Participants will undergo Anterior Cruciate Ligament Reconstruction with Quadriceps tendon-bone graft
15818790|NCT04295135|Behavioral|Chronic Pain OneSheet|The Chronic Pain OneSheet (OneSheet) is an EHR decision support tool that uses behavioral economics to increase adoption of chronic pain guideline recommendations. The OneSheet works by aggregating and structuring information that is already collected, that providers often need while caring for patients with chronic pain conditions. By aggregating and structuring this information in a more convenient manner, the goal of the OneSheet is to make the information that is important in clinical decisionmaking more readily available, and to reduce the amount of time that providers need to spend locating this information.
15818853|NCT04294602|Other|Exercise|Exercise therapy intended in reducing muscle spasm, improving coordination of the mastication muscles and alter the jaw closure pattern.
15818854|NCT04294602|Other|Low Level Laser Therapy|LLLT (max output power: 1200mW, wavelength: 808 nm, dosage: 10j/ cm2 Electronica Pagani Laser Tower Light, Italy) 2.5-4j/TrP dosage was applied to MTrP or sensitive points.
15819204|NCT04291833|Behavioral|Control group 0|no protein supplementation , no Vitamin D and calcium supplementation , no exercise
15818791|NCT04295122|Device|Phacoemulsification+ Endoscopic cyclophotocoagulation (ECP) laser|"A clear corneal incision should be used for instrumentation. The choice of viscoelastics to maintain the anterior chamber is left to the surgeon's discretion.
~Phacoemulsification energy used during the cataract surgery will be recorded. If the patient has been randomised to ECP laser, the viscoelastic will be washed-out of the capsular bag. Further cohesive viscoelastic material will be injected through the main wound between the anterior capsule and iris, until the iris is close to or touching the cornea. A curved ECP probe will be inserted through the corneal incision wound/wounds and 360° of the anterior section of the ciliary processes will be treated. The power setting will be varied according to tissue response (starting power of 250 mW with continuous setting). 'Pops' should be avoided (but recorded) but no indentation used during treatment. Final power used and duration of surgery will be recorded."
15818792|NCT04295109|Drug|the drug of intravenous patient-controlled analgesia|At present, opioids are most widely used in postoperative analgesia. This study aims to use different opioid receptor agonists---fentanyl, oxycodone and butorphanol for analgesia after laparoscopic hysterectomy.Compare the recovery of gastrointestinal function after operation.
15818793|NCT04295096|Device|Peripheral blood mononuclear cell apheresis|Peripheral blood mono-nuclear cell donation for tumor immunotherapy study of Universal CAR-T cells
15818794|NCT04295083|Behavioral|clay based group study|"Clay based group work sessions were applied to the experimental group for 60-90 minutes once a week for 6 weeks. The sessions are composed of structured or semi-structured activities prepared for the purpose of the literature by the researcher for the purposes such as acquiring new solutions and life skills to reduce loneliness and hopelessness of individuals aged 65 and over, and sharing their feelings, thoughts, and memories with other individuals. Clay Study Activity Booklet . Four expert opinions were obtained for the booklet created. Methods such as narration, sharing experiences, group practice, question-answer, learning by doing, imagining were used in the activity program. The physical, psychological, social and mental characteristics of the elderly were taken into consideration in the selection of these methods."
15818795|NCT04295070|Biological|CodaVax-RSV|Codon deoptimized, live-attenuated vaccine against RSV delivered intranasally via dropper
15818796|NCT04295070|Biological|Normal saline|Saline (0.9%) administered via dropper
15818797|NCT04295057|Other|Non-intervention|Non-intervention
15818798|NCT04295044|Dietary Supplement|high protein diet|receive 1.8g protein/kg
15818799|NCT04295018|Drug|C-CAR088|Autologous BCMA-directed CAR-T cells, single infusion intravenously at a target dose of 1.0-9.0 x 10^6 anti-BCMA CAR+T cells/kg. Other Name: CBM.BCMA Chimeric Antigen Receptor T cell.
15818800|NCT04295005|Drug|Empagliflozin|film coated tablet
15818801|NCT04295005|Drug|DPP-4i|film coated tablets
15818802|NCT04295005|Drug|Sitagliptin|film coated tablet
15818803|NCT04295005|Drug|GLP-1-RA|subcutaneous injection or tablet
15818804|NCT04294992|Drug|Ondansetron 8mg|Study drugs will be prepared, diluted to a volume of 10 mL using saline 0.9%
15818805|NCT04294979|Other|Physical Therapy|The rehabilitation program will consist of both passive and active therapeutic exercises specifically aimed at restoring or maintaining muscular flexibility, range of motion, balance, coordination of movements, postural passages and transfers, and ambulation. . Furthermore, advanced robotic therapy such as Lokomat® exoskeleton (Hocoma AG, Volketswil, Switzerland), Biodex® Stability System (BSS, Biodex, Inc, Shirley, NY), G-EO System™ (Reha Technology AG, Olten, Svizzera) and Indego® Therapy (Parker USA), will be used to personalize rehabilitation treatment.
15818806|NCT04294966|Drug|Dextrose|Administering dextrose to health volunteers for our placebo group
15818807|NCT04294966|Drug|Dronabinol|THC (Marinol® [dronabinol]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 mg, in opaque capsules with dextrose filler. Placebo capsules contain only dextrose. These doses of THC are known to produce performance impairments as well as subjective intoxication with little to no adverse reactions in experienced occasional, but non-daily cannabis users (Ménétrey et al., 2005; Issa et al. 2016).
15818808|NCT04294966|Drug|Dronabinol|THC (Marinol® [dronabinol]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 mg, in opaque capsules with dextrose filler. Placebo capsules contain only dextrose. These doses of THC are known to produce performance impairments as well as subjective intoxication with little to no adverse reactions in experienced occasional, but non-daily cannabis users (Ménétrey et al., 2005; Issa et al. 2016).
15818809|NCT04294953|Drug|Duloxetine|Each Patient will receive oral Duloxetine capsule 60mg at the night before operation(12hrs before surgery), the 2nd dose 60 mg Duloxetine capsule 1hr before operation and 3rd dose 60mg capsule after 24hrs postoperative
15818810|NCT04294953|Drug|Placebo oral tablet|Each patient will receive a similar looking placebo capsule in the same time schedule. The placebo capsule will be prepared by hospital pharmacy to insure that active Duloxetine capsules will be indistinguishable from the placebo capsules contained starch
15818811|NCT04294940|Other|Wear an actigraph|"Between visits, tha patient will have to:
~Follow the hygiene-dietetic recommendations given by their centre.
~Wear the actigraph night and day Patients"
15818812|NCT04294940|Other|Use the mobile application CardiCare™ and wear an actigraph|"Between visits, tha patient will have to:
~Follow the hygiene-dietetic recommendations given by their centre.
~Wear the actigraph night and day Patients
~wear their smartphone everyday and use the mobile application CardiCare™"
15818813|NCT04294927|Procedure|Risk-reducing salpingectomy with delayed oophorectomy|"BRCA1: RRS at age 25-40 and RRO at a maximum age of 45 (advised between 35 and 45).
~BRCA2: RRS at age 25-45 and RRO at a maximum age of 50 (advised between age 40 and 50).
~BRIP1, RAD51C, RAD51D: RRS at age 25-50 and RRO at a maximum age of 55 (advised between 45 and 55)"
15818814|NCT04294927|Procedure|Risk-reducing salpingo-oophorectomy|"BRCA1 at a maximum age of 40 (advised between age 35 and 40)
~BRCA2 at a maximum age of 45 (advised between age 40 and 45)
~BRIP1, RAD51C, RAD51D: at a maximum age of 50 (advised between 45 and 50)"
15818815|NCT04294914|Other|Cold Pressor Test|The participant submerges one limb into a tank of cold (1-2 ° C), circulating water.
15818816|NCT04294914|Other|Cold Pressor Test + Virtual Reality|The participant submerges one limb into a tank of cold (1-2 ° C), circulating water while interacting with a virtual reality environment
15818855|NCT04294602|Other|Manuel Pressure Release|MPR technique is a noninvasive method based on pressure on the trigger point in accordance with the patient's tolerance and technique applies supine position relax as much as possible, manuel pressure applied trigger point in neck and mactication muscles
15818817|NCT04294901|Behavioral|Direct to patient medication brochure|An EMPOWER medication brochure, adapted to the VA, designed to educate and activate patients. These brochures provide detailed medication information, allow self-testing of indications for use, prompt reflection of experiences with potential side effects, discuss alternative therapies (medication and non-pharmacologic options), and provide a vignette of a patient who successfully stopped the medicine. They were designed for a 6th grade reading level and were based upon theories of patient activation, adult learning, and cognitive dissonance. The visually appealing brochure repeatedly emphasizes that patients should not make any medication changes without first consulting their health care providers.
15818818|NCT04294888|Device|repetitive transcranial magnetic stimulation (rTMS)|rTMS is a method to focally and reversibly stimulate a pre-specified cortical target. rTMS works through the principle of electromagnetic induction.
15818819|NCT04294875|Drug|MPT0B640|PO, every 3 days. dose escalation per MTD
15818820|NCT04294862|Drug|TNP-2092|TNP-2092 for injection 100mg/vial
15818821|NCT04294849|Other|Magnetic Resonance Imaging|A. Phosphorous 31 MR Spectroscopy to evaluate skeletal muscle metabolism via measurement of depletion and recovery of phosphocreatine (PCr) B. Non-invasive arterial spin labeling MRI to evaluate lymphatic flow velocities and venous flow
15818822|NCT04294849|Other|Bicycle Ergometry|To measure peak VO2 as a representation of global aerobic fitness
15818823|NCT04294849|Other|Lab Panel|A. Inflammatory lab panel (IL-6, IL-8, TNF alpha, P-selectin, high sensitivity CRP, IL-6 receptor, TNF R1/R2) drawn at diagnosis B. Thrombin Generation Assay to measure hypercoagulability and Thromboelastography prior to initiating anticoagulation
15818824|NCT04294849|Behavioral|Questionnaires|A. Dalhousie Dyspnea Scale B. Godin Leisure Time Exercise Questionnaire C. Pediatric Venous Quality of Life Questionnaire
15818825|NCT04294836|Drug|Curcumin|BCM-95® (CURCUGREEN®) is a 100 percent pure extract of turmeric with enhanced bio-availability and bio-efficacy. Its powerful health-promoting benefits are derived from the colorful and aromatic qualities of the Indian spice
15818826|NCT04294836|Drug|Placebo oral tablet|PLACEBO Capsules 500mg
15818827|NCT04294823|Diagnostic Test|Helicobacter Pylori Diagnostic|"Helicobacter Test INFAI with standard test Meal (1g citric acid as test meal and 75 mg C^13 urea)
~+ The C^13 UBT with the new test (REFEX). All patients will take Nexium mups (40 mg) orally once daily 30 min before breakfast from day 1 to 28."
15818828|NCT04294823|Device|Vital signs measurments|No description;
15818829|NCT04294823|Diagnostic Test|endoscopy|Upper endoscopy where 6 biopsy samples will be obtained . Two biopsies will be taken from antrum and corpus for histology. The biopsies will be stained with Haematoxylin & Eosin and Giemsa stains, and gastritis wilt be scored using the Updated Sydney System 12,13 Two biopsies will be taken from antrum and corpus for rapid urease test (RUT) and two biopsies will be taken from antrum and corpus for culture. All biopsy samples will be analysed in the local laboratory of the centre.
15818830|NCT04294823|Drug|Nexium Pill|patients will take Nexium mups 40 mg orally once daily, 30 min before breakfast Nexium mups 40 mg will be discontinued after Day 28.
15818831|NCT04294810|Drug|Atezolizumab|Atezolizumab 1200 milligrams (mg) administered by intravenous (IV) infusion Q3W on Day 1 of each 21-day cycle.
15818832|NCT04294810|Drug|Tiragolumab|Tiragolumab 600 mg administered by IV infusion Q3W on Day 1 of each 21-day cycle.
15818833|NCT04294810|Drug|Matching Placebo|Matching Placebo administered by IV infusion Q3W on Day 1 of each 21-day cycle.
15818834|NCT04294797|Diagnostic Test|Blood draw|One additional blood sample for study purpose from the day before surgery, postoperative 1, 3 and 8.
15818835|NCT04294784|Drug|Albumin-bound Paclitaxel Plus SHR-1210 (PD-1 inhibitor)|Albumin-bound Paclitaxel 100 mg/m2,ivdrip,d1,d8,d15,Q28d;SHR-1210 200mg, ivdrip,d1,Q21d.
15818836|NCT04294784|Drug|Albumin-bound Paclitaxel|Albumin-bound Paclitaxel 100 mg/m2,ivdrip,d1,d8,d15,Q28d.
15818837|NCT04294771|Drug|ICI|Immune checkpoint inhibitor targeting either PD-1, PD-L1 or CTLA-4, and included in the ATC following list (ATC classification): Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC3)
15818838|NCT04294745|Procedure|Buccal infiltration|Injection of local anaesthetic parallel to the Long axis of the tooth in the depth of buccal sulcus
15818839|NCT04294745|Procedure|Inferior alveolar nerve block|Standard technique of mandibular nerve block
15818840|NCT04294732|Drug|Bupivacaine|"bupivacaine is a local anesthetic drug which is already using in surgical procedures.
~saline is isotonic solution of which has include %0,9 NACL."
15818841|NCT04294732|Drug|Only spinal anesthesia without peripheral nerve block|Only spinal anesthesia without peripheral nerve block
15818842|NCT04294719|Other|Cognitive Adaptation Training (CAT)|Cognitive Adaptation Training (CAT) is a standardized implementation of environmental supports for improving adaptive functioning including medication adherence, grooming, and daily activities in patients with schizophrenia. Environmental supports (signs, checklists) are manual-driven and grounded upon an assessment of neurocognitive function and behaviour. Assessment results yield one of six CAT classifications (Apathy/Poor Executive Functioning, Disinhibited/Poor EF, Mixed/Poor EF, Apathy/Fair EF, Disinhibited/Fair EF, Mixed/Fair EF).The goal will be to improve organization and self-care, modifying the intervention to be more relevant for an inpatient setting. Once an individual's CAT classification has been determined, strategies for specific functional problems are chosen from a series of tables. CAT interventions are maintained in the client's living space during weekly visits. CAT clinicians will encourage team members to assist with the reinforcement of CAT tools and strategies.
15818843|NCT04294706|Dietary Supplement|Hemp arm|Hemp oil
15818845|NCT04294667|Drug|DZP|Subjects will receive dapirolizumab pegol at prespecified time-points.
15818846|NCT04294667|Other|Placebo|Subjects will receive placebo at prespecified time-points.
15818848|NCT04294641|Drug|Ibrutinib|140 mg capsules for a dose of 420 mg daily for up to 12 months.
15818849|NCT04294628|Procedure|Biopsy|Undergo biopsy
15818850|NCT04294628|Biological|Trastuzumab Deruxtecan|Given IV
15818856|NCT04294602|Other|Patient Education|Some suggestions were made to TMD people who should pay attention to in daily life. These suggestions were given in writing.
15818858|NCT04294576|Drug|PD-1 or PD-L1 inhibitor|"BJ-001 dosed via SC injection in combination with PD-1 or PD-L1 inhibitor.
~One cycle is 6 weeks."
15818859|NCT04294563|Dietary Supplement|Peanut Protein Powder|Peanut protein powder will be provided to participants who will be instructed to consume 72g daily, mixed with water
15818860|NCT04294563|Other|Standard Care by Surgeon and Physical Therapist|Patient will receive standard care from treating physicians and physical therapists pre- and post-operatively
15818861|NCT04294550|Other|Naloxegol|28 days of therapy with 25 mg/day of Naloxegol on cancer patients using opioids and suffering for opioids induced constipation not relieved by first-line laxatives.
15818862|NCT04294537|Procedure|TAP Block|At the end of surgery patients will receive bilateral ultrasound-guided single-shot TAP block: 0,15% levobupivacaine 0,75 mg/kg per side will be injected between internal oblique and transveralis fascia
15818863|NCT04294537|Procedure|LIA local infiltration|At the end of surgery 0,5% levobupivacaine 1.5 mg/kg, equally distributed between ports, injected in the skin and subcutaneous tissue during wound closure.
15818864|NCT04294537|Procedure|General anesthesia|"General anesthesia will be induced with fentanyl 1,5 mcg/kg, propofol 2 mg/kg, rocuronium 0,6 mg/kg; after intubation anesthesia will be mantained with sevoflurane (MAC 1).
~30 minutes after induction will be administered paracetamol 15 mg/kg iv."
15818865|NCT04294537|Drug|Postperative analgesia|"During first 48 hours after surgery all patients wil receive paracetamol 15 mg/kg iv every 8 hours and ibuprofen 10 mg/kg orally (or through gastric tube) every 12 hours after surgery.
~In case of severe pain tramadol 0,5 mg/kg will be administered iv every 8 hours."
15818866|NCT04294524|Other|Sleep apnea treatment|Sleep apnea treatment as decided according to routine practice. This may be Continuous positive airway pressure (CPAP) or wearing a mandibular advancement device (MAD).
15818867|NCT04294511|Drug|Camrelizumab in Combination With Neoadjuvant Chemotherapy|camrelizumab in combination with adriamycin, cisplatin, ifosfamide and methotrexate
15818868|NCT04294498|Drug|Durvalumab|Entecavir treatment for chronic hepatitis B will be started within one week before initiation of durvalumab treatment for advanced hepatocellulcar carcinoma
15818869|NCT04294485|Behavioral|Physical therapy|Electrostimulation combined with exercise
15818870|NCT04294472|Drug|MAU868|MAU868 is a human monoclonal antibody (IgG1) that binds the viral capsid protein, VP1, that is responsible for binding to the surface of host cells
15818871|NCT04294472|Other|Placebo|250 mL D5W placebo IV to be labeled to match that of MAU868
15818872|NCT04294459|Drug|Isatuximab SAR650984|"Pharmaceutical form: Solution for infusion
~Route of administration: Intravenous"
15818873|NCT04294459|Drug|Acetaminophen (paracetamol) or equivalent|"Pharmaceutical form: Tablets
~Route of administration: Oral"
15818874|NCT04294459|Drug|Ranitidine or equivalent|"Pharmaceutical form: Solution
~Route of administration: Intravenous"
15818875|NCT04294459|Drug|Diphenhydramine or equivalent|"Pharmaceutical form: Solution
~Route of administration: Intravenous"
15818876|NCT04294459|Drug|Methylprednisolone or equivalent|"Pharmaceutical form: Solution
~Route of administration: Intravenous"
15818877|NCT04294459|Drug|Montelukast or equivalent|"Pharmaceutical form: Tablets
~Route of administration: Oral"
15818878|NCT04294446|Device|Biodesign Hernia Graft|The Biodesign Hernia Graft is comprised of 8 layers of decellularized porcine small intestinal submucosa (SIS) that has been pressed-lyophilized (i.e., freeze-dried under vacuum pressure) to laminate the component sheets (i.e., layers) together. In addition, it is perforated and sewn with 4-0 Trisorb suture (polyglycolic acid (PGA); Samyang Corporation, Seoul, South Korea). The suture is distributed in a diamond pattern across the graft and along the periphery and is intended to mitigate delamination of the layers upon rehydration and/or manipulation during implantation. Being a completely biologic device, the Biodesign Hernia Graft is considered MR safe.
15818879|NCT04294433|Biological|Infanrix-hexa, Twinrix-Junior|Vaccines administrated according to product monographs' recommendations
15818880|NCT04294420|Behavioral|Patient education program|The education program provides information and guidance concerning aetiology, diagnostics and treatment of pain-predominant functional gastrointestinal disorders. The patient education program will be provided in a group setting and the children will participate along with one of their parents. The participants (n=20) will be divided into two groups consisting of ten child-parent pairs. Two lectures will be held, two weeks apart, two hours per lecture. Represented teachers are physician, psychologist and dietician.
15818881|NCT04294407|Other|No intervention|no intervention in this study
15818882|NCT04294394|Other|rhomboid block|Rhombid block, on the other hand, is a method which make up analgesia by providing lokal anestethetic enjection between intercostal muscles and rhomboid muscles and blocks between t3- t9 levels
15818883|NCT04294394|Other|erector spinae block|The Erector spinae plan block is a recently developed regional block method .Adminestering of lokal anesthetic between the transver proces and erector spinae muscles provides the dorsal and ventral branch blokades of regional spinal nerve and make up the analgesia.İt have a wide range usage such as surgery of thoracal and abdominal area
15818884|NCT04294394|Other|control|For postoperative analgesia, all patients (including Rhomboid block and Erector spinae block) will be administered 100 mg tramadol and 1 gr paracetamol. No additional intervention other than this medical approach will be applied in the control group.
15818885|NCT04294381|Behavioral|Decision tool|participants will be asked to use a decision tool to choose and delineate SMART health behavior goals
15818886|NCT04294368|Dietary Supplement|Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid|The control group will receive mother's breast milk when it is available. Mother's breast milk will be fortified with 4 packets of Similac Human Milk Fortifier (HMF) per 100 mL. When mother's breast milk is not available, participants will be fed donor breast milk with 4 packets of HMF.
15818887|NCT04294368|Dietary Supplement|Similac Liquid Protein Fortifier|For participants in the control group, additional fortification can be added to the milk for patients in this group in response to poor growth, as is standard of care in the NICU. The standard dose is 1 ml per 30 ml of breast milk.
15818888|NCT04294368|Dietary Supplement|Nestle Microlipid|For participants in the control group, additional fortification can be added to the milk for patients in this group in response to poor growth, as is standard of care in the NICU. The standard dose is 1 ml per 30 ml of breast milk.
15819008|NCT04293510|Procedure|renal biopsy and blood sampling|renal biopsy and blood sampling will be taken from lupus patients for evaluation of Janus-kinase 3
15818889|NCT04294368|Dietary Supplement|Medica Nutrition SolCarb|For participants in the control group, additional fortification can be added to the milk for patients in this group in response to poor growth, as is standard of care in the NICU.
15818890|NCT04294368|Dietary Supplement|Similac Human Milk Fortifier Extensively Hydrolyzed Protein Concentrated Liquid (Targeted Fortification)|The experimental group will receive mother's breast milk when it is available. Mother's breast milk will be fortified with 4 packets of Similac Human Milk Fortifier (HMF) per 100 mL. When mother's breast milk is not available, participants will be fed donor breast milk with 4 packets of HMF. For participants in the experimental group, the investigators will continue to add fortification. Two packets of HMF per day will be added until goal fortification is reached.
15818891|NCT04294368|Dietary Supplement|Similac Liquid Protein Fortifier (Targeted Fortification)|Participants in the experimental group will receive a dose that will vary depending on the base protein content in the donor breast milk for each particular batch of donor breast milk.
15818892|NCT04294368|Dietary Supplement|Nestle Microlipid (Targeted Fortification)|Participants in the experimental group will receive a dose that will vary depending on the base fat content in the donor breast milk for each particular batch of donor breast milk
15818893|NCT04294368|Dietary Supplement|Medica Nutrition SolCarb (Targeted Fortification)|Participants in the experimental group will receive a dose that will vary depending on the base carbohydrate content in the donor breast milk for each particular batch of donor breast milk
15818894|NCT04294368|Other|Analysis with Miris (AB) Human Milk Analyzer|For participants in both the control and the experimental arms, each batch of donor milk will be analyzed using the Miris Human Milk Analyzer. Manufacturer recommendations for milk analysis will be strictly followed.
15818895|NCT04294355|Device|Artificial intelligence-Assisted colonoscopy|Artificial intelligence-Assisted colonoscopy for detection of colonic polyp
15818896|NCT04294355|Procedure|Conventional colonoscopy|Conventional colonoscopy
15818897|NCT04294342|Behavioral|Active Comparator: Participants in 10 week Judo Inspired Exercise program|The intervention included 10 sessions, using a 10-week (45-50 minutes /week) pre-established program called Judo4Balance, a structured exercise program. Each session consisting of warm-up, balance, strength, power and break fall exercises. There is clear a progression within the 10 week program in three main blocks. Block 1: learning the exercises and principle movements, Block 2 more resistance and advance falling techniques, Block 3 Power training and falling strategies from stand up positions.
15818898|NCT04294329|Procedure|US-guided Quadratus lumborum block.|Performance of quadratus lumborum block using ultrasound machine to relieve pain after bariatric surgery
15818899|NCT04294329|Drug|Bupivacaine|Bupivacaine
15818900|NCT04294329|Drug|Saline|normal saline
15818901|NCT04294316|Diagnostic Test|Sonovue|Twice dose of 2.4ml of Sulphur hexafluoride microbubbles contrast Sonovue administration to evaluate brain microcirculation
15818902|NCT04294303|Other|web based telemonitoring system|Subjects in the telemonitoring group were given an iPad with installed iHealth application, a scale, and an electronic blood pressure monitor (a mobile web-based telemonitoring system). These devices were interconnected via Bluetooth. The iPad had permanent internet connection. Patients were taught to use the equipment to check and record their weight, blood pressure, and heart rate every morning, for 45 days after the hospital discharge. Data was automatically uploaded via iHealth application in a secure database.
15818903|NCT04294303|Other|Conventional|Subjects in the control group received the standard patient teaching, including an instruction to self-monitor their weight.
15818904|NCT04294290|Biological|hCT-MSC infusion|This is a single site, phase I, open-label, prospective study of one intravenous infusion of human umbilical cord tissue-derived mesenchymal stromal cells (hCT-MSC) in 12 toddlers 18 to 48 months of age with autism spectrum disorder (ASD).
15818905|NCT04294277|Drug|Pemigatinib|At Day 1, prior to the start of treatment, results from screening visit evaluations are reviewed to determine eligibility requirements. Subsequent visits during treatment phase will take place at Day 8, Day 15 and Day 21 and subsequently at 3 week intervals. Timing of subsequent visits can be prolonged to max. 9 week intervals if no problems exist during the first 12 weeks of therapy. Subjects will self-administer study drug using an oral QD regimen in a continuous dosing schedule. Each dose of Pemigatinib should be taken first thing in the morning upon waking or after a 2-hour fast; subjects should then fast for an additional 1 hour after taking study drug. The starting dose is 13.5 mg Pemigatinib. Study treatment will continue until 12 months, or until the evidence of disease relapse or onset of unacceptable toxicity.
15818906|NCT04294264|Drug|Oxaliplatin|Given IV
15818907|NCT04294264|Drug|Trifluridine and Tipiracil Hydrochloride|Given PO
15818908|NCT04294251|Drug|DWP450|Botulinum toxin type A(DWP450) will be administered intramuscularly to the bilateral masseter muscles on Day 1.
15818909|NCT04294251|Drug|Placebo|Placebo(Normal Saline) will be administered intramuscularly to the bilateral masseter muscles on Day 1.
15818910|NCT04294238|Behavioral|Aerobic exercise|The aerobic exercise intervention consisted of 12 weeks of aerobic exercise training of moderate intensity (about 75 percentage peak heart rate) of 40-60 min per time, 3-5 times per week, at least 150 min per week.
15818911|NCT04294225|Drug|Anastrozole|Given PO
15818912|NCT04294225|Drug|Letrozole|Given PO
15818913|NCT04294199|Other|Early Range of MOtion|Groups will be compared to see if immobilization or early range of motion is better at returning to their sport after patellar dislocation.
15818914|NCT04294173|Behavioral|video education|tracheostomy care will be given to student nurses with video training
15818915|NCT04294160|Drug|Dabrafenib|Capsule for oral use
15818916|NCT04294160|Drug|LTT462|Capsule for oral use
15818917|NCT04294160|Drug|Trametinib|Tablet for oral use
15818918|NCT04294160|Drug|LXH254|Tablet for oral use
15818919|NCT04294160|Drug|TNO155|Capsule for oral use
15818920|NCT04294160|Biological|Spartalizumab|Liquid in vial (Concentrate for solution for infusion) for intravenous use
15818921|NCT04294147|Drug|Galcanezumab|Administered SC
15818922|NCT04294147|Drug|Erenumab|Administered SC
15818965|NCT04293822|Drug|Minoxidil|"The patients will be randomly divided into 2 groups; each group contains 30 patients. Patients in both groups will be given the treatment in identical non-labeled bottles with a code and neither the patient nor the doctor will know which treatment is given and what the code referred to. The patients will be instructed to use the treatment twice daily for 6 month duration.
~This group will use Minoxidil 5% gel"
15818923|NCT04294134|Behavioral|MIO-CPP|"Mothering from the Inside Out (MIO) is an individual, 12-session, manualized, psychotherapeutic intervention designed to promote parental reflective functioning in mothers who are in treatment for SUDs and/or other mental health problems, and caring for a child in-utero through five years old. (Suchman N, Pajulo M, and Mayes LC, 2013).
~Child-Parent Psychotherapy (CPP) is a two-generation approach that supports and strengthens parent-child attachment by integrating modalities derived from psychodynamic, attachment, trauma, cognitive-behavioral, and social learning theories. (Lieberman AF and Van Horn P, 2005 and 2008) Studies have revealed that CPP caregivers' outcomes include decreased depression, PTSD and other symptoms, increased empathy towards children and an increase in the quality of parent-child interactions. CPP focuses on working with families offering weekly sessions for nine-12 months."
15818924|NCT04294134|Behavioral|CPP-only|Child-Parent Psychotherapy (CPP) is a two-generation approach that supports and strengthens parent-child attachment by integrating modalities derived from psychodynamic, attachment, trauma, cognitive-behavioral, and social learning theories. (Lieberman AF and Van Horn P, 2005 and 2008) There have been five randomized trials that provide evidence for the efficacy of CPP, as well as an additional study within a foster care program in Illinois. These studies have revealed that CPP caregivers' outcomes include decreased depression, PTSD and other symptoms, increased empathy towards children and an increase in the quality of parent-child interactions. CPP focuses on working with families offering weekly sessions for nine-12 months. CPP is also very adaptable to suit the needs and composition of each family; it has proven effective with other primary caregivers (e.g., relative caregiver or a foster parent) while the parent is in treatment and once the parent is out of treatment.
15818925|NCT04294121|Other|Food marketing on product packaging|Participants will be exposed to product packages displaying varying child- and parent-appealing marketing techniques and different degrees of marketing power
15818926|NCT04294108|Other|Prolong in-hospital stay|Patients have a longer length of hospital stay than the common recommendation.
15818927|NCT04294095|Other|My Baby My Move +|This is a community-based, peer-led 12-week wellness intervention to decrease excessive gestational weight gain.
15818928|NCT04294095|Other|Control|This is a 12-week basic prenatal education class.
15818929|NCT04294082|Behavioral|Mindfulness based intervention|"A four session, 120 mins per session mindfulness based course delivered weekly oer the course of four weeks. The mindfulness sessions are based on the model delineated by Kabat-Zinn (1992) and will encompass:
~an introduction to mindfulness
~body-scan exercises
~sitting meditation
~mindful movement exercises
~individual and group reflections
~homework exercises"
15818930|NCT04294069|Drug|Azithromycin 500 mg|500mg azithromycin PO for seven days starting on admission
15818931|NCT04294069|Drug|Azithromycin Oral Product|1000mg azithromycin PO once at admission
15818932|NCT04294056|Drug|Ciprofol|First-stage: 0.4mg/kg, 0.6 mg/kg, 0.8 mg/kg Second-stage: 0.4mg/kg, 0.6 mg/kg, 0.8 mg/kg
15818933|NCT04294056|Drug|Propofol|First-stage: 2.0mg/kg, 3.0 mg/kg, 4.0 mg/kg Second-stage: 2.0mg/kg, 3.0 mg/kg, 4.0 mg/kg
15818934|NCT04294043|Drug|Gallium nitrate|Study subjects will receive an infusion of gallium nitrate.
15818935|NCT04294030|Device|Diagnostic Test: NOWDx HSV-2 Test|For this observational trial, the intervention of interest is the NOWDx HSV-2 Test.
15818936|NCT04294004|Combination Product|TGplPTH1-34 in fibrin|TGplPTH1-34 within a fibrin matrix applied within and around a polyetheretherketone (PEEK) intervertebral cage
15818937|NCT04294004|Other|Autologous Bone Graft|Local autograft collected from decompression which may be supplemented with iliac crest bone graft (ICBG) if local autograft is insufficient.
15818938|NCT04293991|Device|High Flow Nasal Cannula|Evaluate the use of HFNC in prevention of intubation in immunocompromised patients adimitted to icu.
15818939|NCT04293991|Device|Non Invasive Ventilation|Evaluate the use of HFNC in prevention of intubation in immunocompromised patient admitted to icu.
15818940|NCT04293978|Behavioral|CalmPlace|Self-contained VR application allowing the user to build and custom a relaxation session, with options to vary session length (9-20 minutes), music/sound, relaxation exercises, and specific nature environment (three available) including time of day and events (e.g. rain). Delivered using an Oculus Go devices in kiosk-mode.
15818941|NCT04293965|Drug|Single ascending dose of X842|A total of 7 dose groups will be set for the ascending dose: 5.6 mg, 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg, 225 mg. In the 5.6 mg dose group, 4 subjects will receive X842; in the 12.5 mg, 25 mg, 50 mg, 100 mg, 150 mg, 225 mg dose groups, 8 subjects in each group will receive X842. Each subject can only receive a certain dose level and cannot enter in multiple dose groups repeatedly.
15818942|NCT04293965|Drug|Multiple ascending dose of X842|Two dose groups will be set, including the groups receiving the recommended phase II dose and a higher dose; Eight subjects will be enrolled in each group, with half male and half female, who will receive X842 once daily for 5 consecutive days. Each subject can only receive a certain dose level and cannot enter in multiple dose groups repeatedly.
15818943|NCT04293965|Other|Food Effect|Twelve subjects (appropriate ratio of male to female) screened for eligibility will be randomized into Group A and B. The 6 subjects in Group A will take the study drug (X842) in fasted condition and subject in Group B will take the study drug in fed condition in the 1st cycle. In the 2nd Cycle, subjects in Group A will take the study drug in fed condition, and subjects in Group B will take the study drug in fasted condition. The interval between the two cycles is at least 7 days.
15818944|NCT04293952|Other|Balance, Resistance, Aerobic, Cognition Exercises (BRACE)|BRACE is a combination of different exercises including Balance, Resistance, Aerobic, Cognition for fall risk reduction and to mobility in the elderly.
15818945|NCT04293952|Other|Balance Resistance Exercise (BRE)|this is the simple conventional treatment for the elderly in balance problems including warm-up, resistance exercises and cool-down exercises.
15818964|NCT04293822|Drug|Cetirizine|"The patients will be randomly divided into 2 groups; each group contains 30 patients. Patients in both groups will be given the treatment in identical non-labeled bottles with a code and neither the patient nor the doctor will know which treatment is given and what the code referred to. The patients will be instructed to use the treatment twice daily for 6 month duration.
~This group will use Cetrizine 1% gel, which will be prepared at the department of Pharmaceutics, Faculty of Pharmacy, Assiut University in the form of Nano-transferosomes (NTF)."
15818966|NCT04293809|Drug|Exparel Injectable Product|bupivacaine liposome injectable suspension
15818967|NCT04293809|Drug|Bupivacaine Hydrochloride|1.3%, 13.3 mg/mL
15819296|NCT04291092|Drug|Immunotherapy|Immunotherapy for brain metastasis
15818946|NCT04293939|Diagnostic Test|Functional Magnetic Risonance Imaging (fMRI) acquisition|Infants will undergo an MRI exam with a 3 Tesla Philips Achieva scanner and a 32-channel head coil. MRI Protocol: T1 weighted image structural, T2 weighted image structural, fMRI task. Task fMRI: experiment will be implemented using the block design is as follow: 1.Rest (control condition): no touch; 2.Soft touch (stimulus condition): gentle strokes on infant's right leg (~15 cm area) with a soft brush at a velocity of ~5 cm/s Stimulus blocks will last for ~15s, allowing the blood-oxygen-level-dependen (BOLD) signal to reach the steady state. Control blocks duration will be randomized (10-18s) to avoid foresee activation phenomena. Condition will be administered multiple times (~10 times). Two run will be administered. The stimulus will be administered using a soft brush. A regular audio signal will help the operator to keep a constant stroke velocity. Audio commands will also be used to direct the operator. Infant must be asleep (natural sleep) during the fMRI acquisition.
15818947|NCT04293926|Other|Exercise|Resistance exercise program for 8 weeks, 3 times a week, with a 60 min session duration.
15818948|NCT04293913|Behavioral|illustrated communication material|Illustrated communication material was introduced to the patients in the intervention group. In the process (intensive care) that patients received mechanical ventilation support after the operation, agitation and sedation levels were monitored by the intensive care nurse who was to communicate with the patient using the Richmond Agitation Sedation Scale (RASS). According to this scale, having minimum -2 and maximum +2 points was accepted as the starting criteria for communication (Sessler et al., 2002). Communication was established with the illustrated communication material.
15818949|NCT04293900|Other|24-hour dietary recall|Dietary intake assessment conducted by a Registered Dietitian Nutritionist. This assessment will occur prior to starting R-CHOP chemotherapy, during the clinic visits for each round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.
15818950|NCT04293900|Other|Hand grip strength|Measurement of grip strength using a hand dynamometer. This will test occur prior to starting R-CHOP chemotherapy, during the clinic visits for each round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.
15818951|NCT04293900|Other|International Physical Activity Questionnaire|Survey about physical activity over the previous 7 days. This survey will be administered prior to starting R-CHOP chemotherapy, during the clinic visits for each round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.
15818952|NCT04293900|Other|Patient-reported outcomes survey|Survey about symptoms and side effects experienced during cancer treatment. This will be administered prior to starting R-CHOP chemotherapy, during the clinic visits for each round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.
15818953|NCT04293900|Other|Pittsburgh Sleep Quality Index|Survey about sleep habits and quality over the past month. This will be administered prior to starting R-CHOP chemotherapy, during the clinic visits for each round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.
15818954|NCT04293900|Other|Functional Assessment of Cancer Treatment - Lymphoma|Survey about quality of life for people with a diagnosis of lymphoma. This will be administered prior to starting R-CHOP chemotherapy, during the clinic visits for each round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.
15818955|NCT04293900|Other|urine sample (optional)|Collect three urine samples either in the clinic or at home. This specimen collection will occur prior to starting R-CHOP chemotherapy, after the third round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.
15818956|NCT04293900|Other|fecal sample (optional)|Collect a fecal sample either in the clinic or at home. This sample collection will occur prior to starting R-CHOP chemotherapy, after the third round of R-CHOP chemotherapy, and again at the end of the scheduled course of R-CHOP chemotherapy.
15818957|NCT04293887|Drug|Recombinant human interferon α1β|Saline needle 2ml + recombinant human interferon α1β10ug bid nebulization inhalation
15818958|NCT04293874|Behavioral|Personalized Meal Plan|Personalized dietary plans will be developed incorporating the NPAGCS, while personalizing the plan based upon anthropometric characteristics, gender, age and self-reported activity level upon entry into the investigation, goals, typical dietary consumption patterns, and food preferences. A trained research assistant will use the USDA MyPlate88 site (www.choosemyplate.gov) to enter participant characteristics and determine the appropriate calorie level. A daily checklist will be then generated outlining the number of daily servings that should be consumed for each food group. Information will also be provided regarding serving sizes for different foods in the respective food groups and education will be provided regarding tailoring personal dietary preferences to meet the guidelines. Participants will be provided with a printed copy of their meal plan and instructed to initiate it for a 8-week period.
15818959|NCT04293874|Behavioral|Dietary Omega-3LC intervention|Following randomization, participants will be provided with fish to be consumed for 6 weeks. As a component of the dietary intervention, participants in high and low omega-3LC group will be provided with frozen, wild caught salmon (or if they dislike salmon, prepackaged, individual use foil packs of chunk light tuna). Salmon and chunk light tuna were chosen due to high omega-3LC content, low methylmercury content, low cost and ease of use. Vacuum packed, frozen salmon will be delivered to participants in large freezer bags and instructed to arrange visit times to ensure they can go directly home following the visit. Instructions for safe storage, fish handling and recipes to avoid fatigue of fish will be also be provided to participants when they receive the fish.
15818960|NCT04293861|Device|HYMOVIS|HYMOVIS is a clear hydrogel obtained by hydration of the HA-based derivative named HYADD4p5. The conjugate compound is constituted by a partial hexadecylamide of hyaluronic acid, which is produced by a fermentation process.
15818961|NCT04293848|Other|Vibroacoustic therapy|listening to low-frequency sound of 40 Hz with biorhythmic sequential modulation combined to music
15818962|NCT04293848|Other|Only music (no vibrations)|listening to music, no vibrations
15818963|NCT04293835|Diagnostic Test|Whether to have intestinal-related disease|All patients pathologically diagnosed with sigmoid or rectal cancer in Peking University Third Hospital from January 2010 to December 2018 were included in our study as the cancer group.To evaluate the relationship between the height of the sigmoid take-off and all baseline covariates in normal patients, the results of 200 patients without any intestinal-related abnormalities who underwent pelvic MRI in our center from January 2019 to June 2019 were reviewed as a normal group.
15819006|NCT04293536|Other|Cases study|Patients with a retained device or almost
15819007|NCT04293523|Drug|ELOCTA|Extended half-life factor VIII product
15818968|NCT04293796|Procedure|Vacuum-assisted biopsy|The vacuum-assisted (7-10G), minimal invasive biopsy (VAB), either guided by ultrasound, after neoadjuvant systemic treatment on patients with clinical complete response on primary breast cancer management we recommend to take at least 12 biopsies with 7-10G needle sizes with sentinel lymph node biopsy.
15818969|NCT04293783|Dietary Supplement|L.Reuteri|daily supplementation with two tablet for six months
15818970|NCT04293783|Dietary Supplement|Placebo|daily supplementation with two tablet for six months
15818971|NCT04293770|Device|Indirect adhesive restoration of posterior teeth|Indirect restoration of significant loss of dental hard tissue
15818972|NCT04293757|Procedure|Rotational angiography|Preprocedural imaging before ablation
15818973|NCT04293744|Device|Colloid priming solution for ECC circuit|Prospective, multi-center, double-blinded, randomized, controlled clinical trial
15818974|NCT04293744|Device|Standard priming solution for ECC circuit|Prospective, multi-center, double-blinded, randomized, controlled clinical trial
15818975|NCT04293731|Dietary Supplement|Symbiter-Smectite|Symbiter-Smectite contains biomass of alive probiotic microorganism symbiosis, colony forming units - CFU/g: Lactobacillus - 1.0х109, Bifidobacterium - 1.0х109, Lactococcus - 1.0х108, Propionibacterium - 1.0х108 and Acetobacter - 1.0х105; and smectite gel (250 mg)
15818976|NCT04293731|Dietary Supplement|Placebo|Placebo
15818977|NCT04293718|Other|papillary gum biopsies|1 or 2 papillary gum biopsies were performed simultaneously, 1 for histological examination and 1 for immunohistochemistry
15818978|NCT04293705|Device|Teen On-line Problem Solving|The TOPS program is a web-based platform delivered on computers and tablets, which is composed of different self-guided, online sessions on different contents: executive functions, social skills, behavioral strategies, injury-related issues and health and wellness. The TOPS program has been designed to be performed by patients and their families at home. Biweekly Google Meet videoconferences between a coach with expertise in cognitive-behavioral psychotherapy and patients are scheduled along the entire duration of the program.
15818979|NCT04293692|Biological|UC-MSCs|0.5*10E6 UC-MSCs /kg body weight suspended in 100mL saline containing 1% human albumin intravenously at Day1, Day3, Day5, Day7
15818980|NCT04293692|Other|Placebo|100mL saline containing 1% human albumin intravenously at Day 1, Day 3, Day 5, Day 7
15818981|NCT04293679|Drug|STP705|Investigational Product
15818982|NCT04293666|Dietary Supplement|Kefir|28 days supplementation kefir drink (prepared by inoculating pasteurized 9.2% reconstituted skim milk with powder kefir starter culture and fermented at 37 °C for 16 h. The fermented milk was then pasteurized at 100 °C for 30 min and freeze dried. The powder kefir starter culture used for inoculation was composed of defined lactic acid bacteria strains which contains Lactobacillus fermentum DSM 32784 (LF26), L. helveticus DSM 32787 (LH43), L. paracasei DSM 32785 (LPC12), L. rhamnosus DSM 32786 (LRH10), and Streptococcus thermophilus DSM 32788 (ST30)), 200ml/day
15818983|NCT04293666|Dietary Supplement|placebo|Maltodextrin, same calorie as kefir, 200ml/day
15818984|NCT04293653|Other|Protocol for patients above 75 undergoing emergency laparotomy or laparoscopy|See above section
15818985|NCT04293640|Diagnostic Test|Parasternal electromyogram measurement|Three electrodes are applied to the chest (two to parasternal muscles, one reference electrode to clavicle). Measurements of EMG signals are recorded on appropriate software.
15818986|NCT04293627|Behavioral|ATTAIN|ATTAIN is an 8-step model to identify co-occurring mental health conditions and facilitate linkage to mental health services for youth with an existing autism spectrum disorder diagnosis.
15818987|NCT04293601|Other|interventional nursing care|"The infants enrolled will receive different intervention according to a defined risk factor level:
~Low:
~NCPAP duration < 48 hours (h)
~Gestational Age (GA) > 32 weeks (wks)
~Current weight > 1500 g
~Interventions:
~alternating mask or nasal prongs once per shift
~skin assessment (excoriation, erythema or skin breakdown) once per shift
~Medium:
~NCPAP duration from 48 to 72 h
~GA from 32 to 28 wks
~Current weight from 1500 to 1000 g
~Interventions:
~alternating mask or nasal prongs twice per shift
~skin assessment (excoriation, erythema or skin breakdown) twice per shift
~repositioning of device once per shift
~High:
~NCPAP duration > 72 h
~GA < 28 wks
~Current weight < 1000 g
~Interventions:
~alternating mask or nasal prongs twice per shift
~skin assessment (excoriation, erythema or skin breakdown) every 3 h per shift
~repositioning of device every 3 h per shift"
15818988|NCT04293601|Other|Standard nursing care|"Use of hydrocolloid as nasal barrier dressing
~Appropriate size of headbands, indicated by production company
~Appropriate size of mask or binasal prongs, indicated by production company
~Frequently assess skin integrity, every 4 hours
~Replace hydrocolloid if it's dirty or displaced
~Humidity and heat gases"
15818989|NCT04293588|Diagnostic Test|spirometry, FOT, Induced sputum, bloods, nasal brushes, nasal lavage, skin prick, throat swab|At the point of baseline visit, exacerbation and annual visit, the above tests will be performed to allow comparison of a participants profile before and during an exacerbation
15818990|NCT04293575|Device|MitraClip|transcatheter MitraClip device (Abbott Vascular, Santa Clara, California)
15819005|NCT04293549|Drug|Cenegermin, recombinant human Nerve Growth Factor (rhNGF) eyedrops|"rhNGF 20µg/ml (Cenegermin) eyedrops, 1 drop every 2 hours (6 times a day) for 8 weeks.
~Patients underwent clinical examination with corneal fluorescein staining, Schirmer I tear test, assessment of corneal sensitivity with Cochet-Bonnet aesthesiometer and morphological examination of the nerves by In Vivo Confocal Microscopy (IVCM) at baseline and after 4 and 8 weeks of treatment"
15819009|NCT04293497|Diagnostic Test|Cytology staining|"Two staining will be performed in cytology specimens obtained from same patient. The cytology specimen will be obtained using endoscopic ultrasound-guided fine needle aspiration. Three types of slides (direct smear, thinprep, surepath) are prepared for staining.
~conventional cytology staining method
~new cytology staining method using antibody of methionyl-tRNA synthetase 1"
15819010|NCT04293484|Device|Anodal bilateral motor cortex and cathodal spinal tDCS|10 sessions of anodal bilateral motor cortex and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks)
15819011|NCT04293484|Device|Sham bilateral motor cortex and sham spinal tDCS|10 sessions of sham bilateral motor cortex and sham spinal transcranial direct current stimulation (5 days/week for 2 weeks)
15819012|NCT04293458|Device|EsoGuard|EsoGuard assay (LDT) will be used on cells collected using EsoCheck (510K cleared esophageal cell collection device) and compared to results of EGD plus biopsies (when taken)
15819013|NCT04293445|Diagnostic Test|spirometry, FOT, Induced sputum, bloods, nasal brushes, nasal lavage, skin prick, throat swab|At the point of baseline visit, exacerbation and annual visit, the above tests will be performed to allow comparison of a participants profile before and during an exacerbation
15819014|NCT04293432|Drug|Drugs, Generic|All drugs having ≥10 TdP cases reported in the FAERS database
15819015|NCT04293419|Drug|Durvalumab (MEDI4736)|6 cycles of mFOLFOX6 (oxaliplatin, leucovorin and fluorouracil) followed by long course chemoradiotherapy (50.4 Gy together with capecitabine) followed by surgery. Patients will receive durvalumab 1500 mg every 4 weeks during induction chemotherapy, chemoradiotherapy and waiting period until surgery.
15819016|NCT04293406|Other|Decision Navigation Intervention (DNI)|This study will develop and test the acceptability and feasibility of a decision navigation intervention (DNI) for AA or H/L men with prostate cancer through consideration of the role of partners and family members in the decision-making process. In the decision navigation intervention (DNI), participants will meet with the navigator in person or via phone, prior to their specialist treatment consultation. At the end of the DNI visit, participants will receive a personalized list of prioritized questions. At the end of the decision navigation appointment, all navigated patients will complete a five-item navigation rating scale evaluating the intervention and its impact on their preparation for the consultation visit.
15819017|NCT04293393|Drug|Doxorubicin|Doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 (AC) every 21 days for 4 cycles followed by weekly paclitaxel 80mg/m2 for 12 weeks or 3-weekly docetaxel 100mg/m2 for 4 cycles.
15819018|NCT04293393|Drug|Cyclophosphamide|Doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 (AC) every 21 days for 4 cycles followed by weekly paclitaxel 80mg/m2 for 12 weeks or 3-weekly docetaxel 100mg/m2 for 4 cycles.
15819019|NCT04293393|Drug|Taxane|Doxorubicin 60mg/m2 and cyclophosphamide 600mg/m2 (AC) every 21 days for 4 cycles followed by weekly paclitaxel 80mg/m2 for 12 weeks or 3-weekly docetaxel 100mg/m2 for 4 cycles.
15819020|NCT04293393|Drug|Letrozole|Letrozole 2.5mg orally daily + abemaciclib 150mg orally every 12 hours on a continuous dosing schedule, +/- LHRH analogs in premenopausal women, up to 12 months, in 28-day cycles
15819021|NCT04293393|Drug|Abemaciclib|Letrozole 2.5mg orally daily + abemaciclib 150mg orally every 12 hours on a continuous dosing schedule, +/- LHRH analogs in premenopausal women, up to 12 months, in 28-day cycles
15819022|NCT04293393|Drug|LHRH Analogue|Letrozole 2.5mg orally daily + abemaciclib 150mg orally every 12 hours on a continuous dosing schedule, +/- LHRH analogs in premenopausal women, up to 12 months, in 28-day cycles
15819023|NCT04293380|Procedure|amniosyntesis|
15819024|NCT04293367|Other|High Intensity Interval Training (HIIT)|"HIIT involves exercising in blocks of time (typically 4-5 minutes) where a small percentage of the time (typically 1 minute) is spent above the anaerobic (lactate) threshold (the work interval) followed by the remainder of the time at a sub-anaerobic threshold (active recovery)."
15819025|NCT04293354|Procedure|Serratus Plane Block|Serratus Plane Block was performed
15819026|NCT04293354|Procedure|Control|No block was performed
15819027|NCT04293341|Behavioral|Transdiagnostic Behavior Therapy|TBT was developed to address transdiagnostic avoidance via the use of four different types of exposure techniques (situational/in-vivo, physical/interoceptive, thought/imaginal, and [positive] emotional/behavioral activation). From the transdiagnostic avoidance perspective, the four exposure practices are matched to the type(s) of avoidance experienced by patients based upon their cluster of symptoms/disorders.
15819028|NCT04293341|Behavioral|Cognitive Processing Therapy for PTSD|CPT is a well established evidence-based psychotherapy for PTSD. CPT focuses on teaching patients to evaluate and change the upsetting thoughts that they have had since their trauma.
15819029|NCT04293341|Behavioral|Cognitive Behavioral Therapy for MDD|CBT for MDD is a well established evidence-based psychotherapy for depression. CBT for MDD focuses teaching patients how to change their behaviors and challenge their negative thoughts to improve their mood.
15819030|NCT04293341|Behavioral|Cognitive Behavioral Therapy for Panic Disorder|CBT for Panic Disorder is a well established evidence-based psychotherapy. CBT for Panic Disorder focuses teaching patients how to change their behaviors through exposure practices and challenge their anxious thoughts to reduce their experience of panic attacks and avoidance.
15819031|NCT04293328|Device|orthokeratology|Nightly wear of orthokeratology lenses to correct vision in the daytime
15819032|NCT04293328|Device|Menicon Progent A+B|Menicon Progent A+B is a commercially available protein remover for rigid lenses. It has received FDA clearance and been launched in Hong Kong for over a decade. The product contains two separate sterile solutions, one with sodium hypochlorite and the other with potassium bromide. By mixing the two solutions in a special vial, it can clean and remove protein deposits on the lenses. Parents of subjects assigned to use weekly protein remover will be required to soak the cleansed lenses in the solution mixture for not more than 30 mins every week. All lenses must be rinsed thoroughly with saline and cleansed with daily cleaner again before daily disinfection.
15819033|NCT04293315|Behavioral|Improvement Cycles|"This is a multi-component intervention following the Institute for Healthcare Improvement (IHI)'s Collaborative Model for Achieving Breakthrough Improvement by implementing plan-do-study-act (PDSA) improvement cycles. The investigators will conduct 8 participative learning sessions for the primary care team. These sessions will be aimed at identifying opportunities for improvement oriented to the design and application of innovative approaches based on best practices."
15819034|NCT04293302|Other|No intervention|No intervention
15819297|NCT04291092|Radiation|WBRT|local therapy for brain metastasis
15819035|NCT04293289|Other|CICS-1 (investigational device),SPM-011(investigational drug)|Intravenous administration of SPM-011 and neutron irradiation with CICS-1.
15819036|NCT04293276|Drug|Pyrotinib|Pyrotinib Tablets
15819037|NCT04293276|Drug|SHR6390|SHR6390 Tablets
15819038|NCT04293263|Combination Product|2gether app used by trained personal|"each of the elderly in the study group will listen to personalized music twice a week for an hour each time together with a musical partner. Joint listening is performed with 2 pairs of headphones that connect via a splitter to the partner's cell phone. A listening session will take place in a period of 30 minutes and not more than 60 minutes.
~Musical partner - A person trained in the program's work plan, which includes contact with empathic listening and the use of a dedicated application developed for it. A musical partner will meet with the same elderly person throughout the study period.
~Empathetic listening - a situation in which a person listens to music with another person, while the music enables contact and deepening the connection between people."
15819039|NCT04293250|Procedure|Compare the severity of postoperative pain of the physical activity group Vs non-physical activity group|Compare postoperative pain scores for the physical activity Vs non-physical activity group
15819040|NCT04293224|Other|DGA Mediterranean diet pattern, energy balance|Foods and beverages will be provided for participants for eight weeks. During the controlled feeding portion of the study the DGA Mediterranean diet pattern will be based on the Table A7-1 of the 2015 Dietary Guidelines for Americans which outlines daily nutritional goals for age-sex groups based on Dietary Reference Intakes (DRI) and dietary guidelines recommendations.
15819041|NCT04293224|Other|DGA Mediterranean diet pattern, negative energy balance|Foods and beverages will be provided for participants for eight weeks. During the controlled feeding portion of the study the DGA Mediterranean diet pattern will be based on the Table A7-1 of the 2015 Dietary Guidelines for Americans which outlines daily nutritional goals for age-sex groups based on Dietary Reference Intakes (DRI) and dietary guidelines recommendations
15819042|NCT04293224|Other|TAD diet pattern, negative energy balance|Foods and beverages will be provided for participants for eight weeks. During the controlled feeding portion of the study the be based on evidence collected from What We Eat in America (WWEIA) data. Based on this data the participants will be provided a diet that reflects American dietary trends.
15819043|NCT04293211|Other|Simulation|To measure the efficacy of adding a high-fidelity simulation versus low fidelity simulation to the current B-Con Course. This will be assessed by evaluation of applying tourniquets properly and packing traumatic wounds as well as retention of these skills over a period of time amongst school teachers and security personnel.
15819044|NCT04293198|Device|KODEX-EPD System|The KODEX - EPD system is an open platform that uses any validated EP catheter to create real-time 3D images of the human heart.
15819045|NCT04293185|Genetic|bb1111|Drug Product is administered by IV infusion following myeloablative conditioning with busulfan.
15819046|NCT04293172|Drug|Brilinta|"Patients in the open-label Run-in period (patients aged 6 to <24 months only) will receive ticagrelor 5 mg twice a day (body weight 6 to ≤9 kg), 10 mg twice a day (body weight >9 to ≤12 kg) or 15 mg twice a day (body weight >12 to ≤24 kg) for 14 days.
~The double-blind IP will be based on 5 weight bands:
~6 to ≤9 kg: ticagrelor 5 mg or matching placebo, twice a day
~>9 to ≤12 kg: ticagrelor 10 mg or matching placebo, twice a day
~>12 to ≤24 kg: ticagrelor 15 mg or matching placebo, twice a day
~>24 to ≤48 kg: ticagrelor 30 mg or matching placebo, twice a day
~>48 kg: ticagrelor 45 mg or matching placebo, twice a day"
15819047|NCT04293172|Drug|Placebo|"Patients in the open-label Run-in period (patients aged 6 to <24 months only) will receive ticagrelor 5 mg twice a day (body weight 6 to ≤9 kg), 10 mg twice a day (body weight >9 to ≤12 kg) or 15 mg twice a day (body weight >12 to ≤24 kg) for 14 days.
~The double-blind IP will be based on 5 weight bands:
~6 to ≤9 kg: ticagrelor 5 mg or matching placebo, twice a day
~>9 to ≤12 kg: ticagrelor 10 mg or matching placebo, twice a day
~>12 to ≤24 kg: ticagrelor 15 mg or matching placebo, twice a day
~>24 to ≤48 kg: ticagrelor 30 mg or matching placebo, twice a day
~>48 kg: ticagrelor 45 mg or matching placebo, twice a day"
15819048|NCT04293159|Dietary Supplement|Lactobacillus casei DG (Enterolactis duo®)|Lactobacillus casei DG (Enterolactis duo®)
15819049|NCT04293146|Procedure|pre-pectoral IBBR|The breast is reconstructed by positioning a breast implant above (pre-pectoral) the pectoralis major muscle.
15819050|NCT04293146|Procedure|sub-pectoral IBBR|The breast is reconstructed by positioning a breast implant below (sub-pectoral) the pectoralis major muscle.
15819051|NCT04293120|Other|Training with weighted ball|Participants will stop or catch a weighted ball
15819052|NCT04293094|Drug|AMG 650|AMG 650 administered orally as a tablet.
15819053|NCT04293081|Drug|Preemptive chlorepheniramine maleate intravenous injection|Participants of group A will receive only one ampoule of 45.5 mg/ 2mL chlorepheniramine maleate diluted in 8 ml isotonic saline intravenous (I.V) prior to induction of general anesthesia by 30 minutes
15819054|NCT04293081|Drug|normal saline|participants in group (B) will receive 10 ml isotonic saline (placebo) by the same route as control.
15819055|NCT04293055|Behavioral|Maintenance program|1-year weight loss maintenance program, consisting of monthly newsletters
15819056|NCT04293055|Behavioral|Phone coaching|Some individuals will receive 4 consecutive weeks of phone coaching. The first coaching call will be approximately 30 minutes in duration and follow-up calls will be 10-15 minutes in duration. Coaches will help support participants in their weight loss maintenance efforts. Once coaching calls are completed, the participant will not have any other contact with their coach.
15819057|NCT04293042|Biological|BK-virus specific CTLs|"HLA Matched Related Donors: BK-virus specific CTLs (2.5 x 104 CD3/kg) infused intravenously on day 0 and may be additionally reinfused at a minimum of every two weeks (depending on safety and efficacy) for a maximum of five total infusions (maximum 12.5 x 104 CD3/kg).
~HLA Mismatched Related Donors: BK-virus specific CTLs (0.5x104 CD3/kg) infused intravenously on day 0 and may additionally be reinfused at a minimum of every two weeks (depending on safety and efficacy) for a maximum of five total infusions (maximum 2.5 x 104 CD3/kg)."
15819058|NCT04293029|Drug|SHR0302|SHR0302
15819059|NCT04293016|Behavioral|Support as usual|this group receives current best practice which includes participation in ICU support groups and provision of community support resources
15819060|NCT04293016|Behavioral|problem solving therapy|This group will receive one on one therapy based on identifying stressors and solutions to those stressors
15819298|NCT04291092|Drug|Chemotherapy|Chemotherapy for brain metastasis
15819299|NCT04291079|Biological|SRK-181|anti-latent TGFβ1 monoclonal antibody
15819061|NCT04293016|Behavioral|ICU diary|This group will provided with a structured written diary that includes identification of stressors and development of solutions to those stressors
15819062|NCT04293003|Other|fasting|6-hour fasting
15819063|NCT04293003|Other|Low carbohydrate|Consumption of a zero-carbohydrate breakfast
15819064|NCT04293003|Other|Mediterranean|Consumption of a Mediterranean-type breakfast
15819065|NCT04292990|Drug|Fentanyl|Patch releasing drug at the rate of 25 µg/hour, increasing by 25 µg/hour increments to maintain the NRS score≤3 after the frst 24 hours according to no change in pain control. The maximum dose allowed in this study is 300 µg/hour.
15819066|NCT04292990|Drug|Morphine|Tablets taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. Titration phase: starting at 30 mg, increasing at a minimum of 3 days intervals by 20 mg, with a maximum dose of 100 mg. Maintenance phase: continuing on dose level established in titration phase.
15819067|NCT04292951|Procedure|Fluid and inotropic/vasoactive management protocol|GDT protocol: keep SVV 10-13% and give fluid when SVV > 13%, give inotropic to maintain CI 2.5-4 L/min/m2, give vasoactive drugs to maintain SVRI 1,900-2,400 dynes-sec/cm-5/m2 Control protocol: keep CVP 8-12 mmHG and give fluid when CVP < 8 mmHg, give inotropic/vasoactive to maintain normal blood pressure and heart rate
15819068|NCT04292938|Dietary Supplement|Low carbohydrate ketogenic diet|Dietary modification, including the use of supplements, with the aim of reaching a lipid/carbohydrate-protein 3:1 ratio with a minimum 1g/Kg/die in protein
15819069|NCT04292925|Other|New treatment protocol|The new treatment protocol focuses on training of executive processes using remedial strategies and on promoting the use of meta-cognitive strategies. Goal directed activities are used to improve the underlying cognitive process and transfer of the learned skill to everyday function will be encouraged.
15819070|NCT04292925|Other|Conventional therapy|conventional therapy
15819071|NCT04292912|Drug|GSK2798745|GSK2798745 will be administered.
15819072|NCT04292899|Drug|Remdesivir|Administered as an intravenous infusion
15819073|NCT04292899|Drug|Standard of Care|Standard of Care Treatment for COVID-19 Infection
15819074|NCT04292886|Drug|Tamoxifen and femoston|oral
15819075|NCT04292886|Drug|Vitamin C and femoston|Vitamin C and femoston
15819076|NCT04292873|Other|Vitamin D supplement|Enteral supplement of 569,600 IU vitamin D
15819077|NCT04292847|Other|Referrals Recommendations|All participants will complete the geriatric assessment and receive Referral recommendations based on the assessment.
15819078|NCT04292808|Drug|Methoxyflurane|Methoxyflurane inhaler during out-patient aesthetics surgery or facial dermal fillers.
15819079|NCT04292795|Device|Therapeutic Ultrasound|The Intervention will be provided according to the set protocols used in previous literature.
15819080|NCT04292795|Device|Short wave diathermy|The Intervention will be provided according to the set protocols used in previous literature.
15819081|NCT04292782|Procedure|anterior Quadratus lumborum block|ultrasound anterior quadratum lumborum block with 1 ml/kg 0.2% ropivacaine
15819082|NCT04292782|Procedure|caudal block|ultrasound guided caudal block with 1 ml/kg 0.2% ropivacaine
15819083|NCT04292769|Drug|Decitabine|Decitabine 10mg / d, intravenous administration d-5 ～ d-1
15819084|NCT04292769|Biological|DC-CIK|Autologous DC-CIK cell infusion: the first course: d1-d3, the second course: d14-d16; the total number of cells is about 5-10 × 109;
15819085|NCT04292756|Procedure|Subtenon injection of 40 mg triamcinolone acetonide|Subtenon injection of 40 mg triamcinolone acetonide: 1 initial injection of 40 mg triamcinolone acetonide, further injections will be base at month 3 examination.
15819086|NCT04292756|Procedure|Intravitreal injection of 4 mg triamcinolone acetonide|Intravitreal injection of 4 mg triamcinolone acetonide: 1 initial injection of 4 mg triamcinolone acetonide, further injections will be base at month 3 examination.
15819087|NCT04292756|Diagnostic Test|Visometry|Ophthalmic examination
15819088|NCT04292756|Diagnostic Test|Fluorescent angiography|Ophthalmic examination
15819089|NCT04292756|Diagnostic Test|Refractometry|Ophthalmic examination
15819090|NCT04292756|Diagnostic Test|Slit lamp examination|Ophthalmic examination
15819091|NCT04292756|Diagnostic Test|Ophthalmoscopy|Ophthalmic examination
15819092|NCT04292756|Diagnostic Test|OKT|Ophthalmic examination
15819093|NCT04292756|Diagnostic Test|IOP|Ophthalmic examination
15819094|NCT04292743|Biological|Eryaspase|intravenous administration of Eryaspase, starting dose 75 units/kg, dose escalation to 100 units/kg, dose reduction 50 units/kg and 25 units/kg
15819095|NCT04292743|Drug|FOLFIRINOX|intravenous administration of FOLFIRINOX
15819096|NCT04292730|Drug|Remdesivir|Administered as an intravenous infusion
15819097|NCT04292730|Drug|Standard of Care|Standard of Care Treatment for COVID-19 Infection
15819098|NCT04292717|Behavioral|Gait training|All participants will receive training three times a week for 6 weeks (18 training sessions) at the University Hospital Balgrist, Spinal Cord Injury Centre. Each exercise session will last for 1 hour and will be conducted and supervised by an experienced physical therapist.
15819099|NCT04292704|Radiation|the fractional CO2 laser|The fractional CO2 laser therapy mechine: the wavelength is 10.6 μ m, the output power is 40 w, the action time is 2000 μ s and the lattice spacing is 700 ~ 1000 μ m
15819100|NCT04292704|Drug|Clotrimazole|Clotrimazole vaginal tablets
15819101|NCT04292691|Drug|40ml of Ropivacaine 0.5% Injectable Solution|already outlined in the arm/group description
15819102|NCT04292691|Drug|40ml of Ringer's Lactate|already outlined in the arm/group description
15819103|NCT04292678|Behavioral|Progressive muscle relaxation|The progressive muscle relaxation intervention will last for 20 minutes and comprise sessions involving tensing and relaxing the body with deep breathing. The participants will perform progressive muscle relaxation for each body part in order, starting with the facial muscles and head, followed by neck, shoulders, chest, abdomen, legs, and feet; all muscle tension and relaxation procedures were performed accompanied with deep breathing. The participants will be instructed to tense a specified group of muscles for 5 s and relax it for 10 s while breathing out. Throughout this exercise, the participants will visualize a wave of relaxation flowing over their body using the deep-breathing technique.
15819201|NCT04291846|Drug|SHR1459 high-fat diet in P1, fasted in P2|SHR1459 administration after high-fat diet in period 1, SHR1459 administration in fasted condition in period 2
15819104|NCT04292678|Other|Attention matched control|Caregivers of patients with advanced cancer will receive only a training group session about general cancer information such as risk factors, treatment methods, and treatment-related side effects, lasting 20 minutes first week of the study.
15819105|NCT04292665|Behavioral|Classical Massage|During the first interview, a booklet explaining the introduction, purpose, benefits and application steps of hand-foot massage will be given to the patients in the classical massage group. Hand and foot massage will be applied to the patients for 30 minutes in the form of right hand five minutes, left hand five minutes, right foot ten minutes, left foot ten minutes, using liquid vaseline in each session twice a day in the patient's own bed with individual applied sessions by the researcher. Patients will receive a total of 14 sessions of classical massage, twice a day, for seven days.
15819106|NCT04292665|Behavioral|Benson Relaxation Exercise|During the first interview, patients will be given a booklet explaining the description, purpose, benefits and application steps of the Benson relaxation exercise. With individual counseling sessions, a total of 14 sessions of Benson relaxation exercises will be performed in a quiet room, twice a day for seven days, each session lasting 20 minutes. At the beginning of the application, patients will focus on their breaths by taking slow and natural breaths with the researchers' commands and will quietly say to yourself the words of the focus, sound, sentence or prayer they choose, which are meaningful to them.
15819107|NCT04292665|Other|Control|Patients will continue to receive standard nursing care and no further intervention will be made during the research.
15819108|NCT04292652|Procedure|AAA surgery|EVAR is a mini invasive procedure to exclude aortic aneurysms with the intention to prevent rupture. Open repair is the traditional open surgical procedure for the same condition.
15819109|NCT04292639|Device|The Vital Detect Pulse Oximeter|The Vital Detect is a noninvasive device designed for spot-checking physiological parameters, such as Noninvasive Blood Pressure, Oxygen Saturation, Pulse Rate, Body Temperature, and Respiratory Rate. This device is a finger-cuff technology which is applicable for use at-home or in healthcare facilities in/on individuals 18 years of age and older. It may be used by the individual themselves or an operator. The Vital Detect is not intended for continuous monitoring or for use with high frequency surgical equipment. It is non transit-operable. The Vital USA Vital Detect is composed of a sensor head mounted on a base connected to a phone or computer via Vital Detect App which is free to download.
15819110|NCT04292626|Diagnostic Test|SPECT with 99mTc-1-thio-D-glucose|One single intravenous injection of 99mTc-1-thio-D-glucose, followed by gamma camera imaging directly postinjection and after 2, 4, 6 and 24 hours.
15819111|NCT04292613|Other|"The Effect of Hemiplegic Shoulder Pain on Balance, Upper Extremity Function and Quality of Life"|"The Effect of Hemiplegic Shoulder Pain on Balance, Upper Extremity Function and Quality of Life"
15819112|NCT04292600|Diagnostic Test|POCKiT diagnostics' algorithm for LVO detection|Measurement of blood biomarkers and integration within Pockit diagnostics' algorithm for LVO detection
15819113|NCT04292574|Other|Patient Registry|Participants who have volunteered to participate will complete various questionnaires relating to their conditions.
15819114|NCT04292561|Drug|Low MAC|To maintain a target of sevoflurane inhalation concentration 0.8 MAC.
15819115|NCT04292561|Drug|High MAC|To maintain a target of sevoflurane inhalation concentration 1.0 MAC.
15819116|NCT04292548|Diagnostic Test|taking saliva samples to determine TAS, TOS and LL-37|
15819117|NCT04292535|Drug|Placebo into the intranasal mucosa|6 doses of 0.2mL saline solution administered into the intranasal mucosa using the MAD Nasal Atomizer
15819118|NCT04292535|Drug|20 IU NovoLog Insulin aspart into the intranasal mucosa|5 doses of 0.2mL saline solution, 1 dose of 0.2mL NovoLog Insulin aspart (20 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
15819119|NCT04292535|Drug|40 IU NovoLog Insulin aspart into the intranasal mucosa|4 doses of 0.2mL saline solution, 2 doses of 0.2mL NovoLog Insulin aspart (40 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
15819120|NCT04292535|Drug|60 IU NovoLog Insulin aspart into the intranasal mucosa|3 doses of 0.2mL saline solution, 3 doses of 0.2mL NovoLog Insulin aspart (60 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
15819121|NCT04292535|Drug|80 IU NovoLog Insulin aspart into the intranasal mucosa|2 doses of 0.2mL saline solution, 4 doses of 0.2mL NovoLog Insulin aspart (80 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
15819122|NCT04292535|Drug|100 IU NovoLog Insulin aspart into the intranasal mucosa|1 dose of 0.2mL saline solution, 5 doses of 0.2mL NovoLog Insulin aspart (100 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
15819123|NCT04292535|Drug|120 IU NovoLog Insulin aspart into the intranasal mucosa|6 doses of 0.2mL NovoLog Insulin aspart (120 IU) administered into the intranasal mucosa using the MAD Nasal Atomizer
15819124|NCT04292509|Device|SAP with stop before low|cross-over comparison from stop on low to stop before low
15819125|NCT04292509|Device|SAP with stop on low|cross-over comparison from stop before low to stop on low
15819126|NCT04292496|Procedure|Introperative leak testing|After anastomosis was completed. We test the integrity of anastomosis intraoperatively.
15819127|NCT04292483|Drug|Nitric Oxide|Inhaled nitric oxide to increase pulmonary capillary perfusion
15819128|NCT04292470|Drug|Amitriptyline|Amitriptyline tablet
15819129|NCT04292457|Drug|Propofol|Anesthesia is maintained with a continuous infusion of Propofol. Induction of anesthesia and anesthetic management are otherwise the same in both study arms.
15819130|NCT04292457|Drug|Sevoflurane|Anesthesia is maintained with a continuous inhalation of Sevoflurane. Induction of anesthesia and anesthetic management are otherwise the same in both study arms.
15819131|NCT04292444|Drug|Oxytocin nasal spray|Intranasal administration of 24 International Units oxytocin 30 minutes before the start of the tasks.
15819132|NCT04292444|Drug|Placebo|The placebo nasal sprays contain identical ingredients except for the peptide itself (30 minutes before the start of the tasks).
15819133|NCT04292418|Drug|Tacrolimus capsule , mycophenolic acid|measuring tacrolimus level by elisa test then correlated with hematocrit level measuring mycophenolic acid by elisa test for study group 1 and study group 2
15819202|NCT04291833|Behavioral|Intervention group 1|Protein supplementation BID, Vitamin D and calcium supplementation Vitamin D 2000 IU / d, calcium 1000mg/d, exercise 6 months
15819135|NCT04292392|Other|preop ACB, followed by Intra-articular block during TKA surgery|"Preoperative ACB (adductor canal block), followed by a local anesthetic injection during surgery, which is comprised of the following agents and amounts:
~Ropivacaine 5mg/ml (49.25ml)
~Epinephrine 1mg/ml (0.5ml)
~Ketorolac 30mg/ml (1ml)
~Clonidine 0.1mg/ml (0.8ml)
~Saline 48.45ml"
15819136|NCT04292392|Other|preop ACB+IPACK block|Preoperative ACB (adductor canal block) and IPACK (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) block
15819137|NCT04292392|Other|preop ACB+IPACK block, followed by Intra-articular block during TKA surgery|"Preoperative ACB (adductor canal block) and IPACK (Interspace between the Popliteal Artery and the Capsule of the posterior Knee) block, followed by a local anesthetic injection during surgery, which is comprised of the following agents and amounts:
~Ropivacaine 5mg/ml (49.25ml)
~Epinephrine 1mg/ml (0.5ml)
~Ketorolac 30mg/ml (1ml)
~Clonidine 0.1mg/ml (0.8ml)
~Saline 48.45ml"
15819138|NCT04292366|Procedure|Invitation procedure|Optimised invitation procedures in an organised colorectal cancer screening programme
15819139|NCT04292353|Other|Cognitive tests and Patient Reported Outcome|
15819140|NCT04292314|Drug|Omega 3|Omega-3 supplementation (300-400mg EPA & 200-300mg DHA) per day for 8 consecutive months up to 10 months
15819141|NCT04292314|Drug|Nigella Sativa Oil|Nigella sativa supplementation (1g black seed oil contain 1% thymoquinone) per day for 8 consecutive months up to 10 months
15819142|NCT04292314|Drug|Hydroxyurea|hydroxyurea medication (5 to 15mg/kg) per day for 8 consecutive months up to 10 months.
15819143|NCT04292314|Drug|Honey|Natural honey(2.5 mg/kg dissolved in 250 ml water) per day for 8 consecutive months up to 10 months.
15819144|NCT04292314|Drug|Deferoxamine|deferoxamine (SubQ infusion: 20 to 40 mg/kg/day over 8 to 12 hours, 6 to 7 nights per week, maximum daily dose: 40 mg/kg/day)for 8 consecutive months up to 10 months.
15819145|NCT04292314|Procedure|blood transfusion session|Regular blood transfusion session based on patient hematological profile starts from one session every 2 weeks.
15819146|NCT04292301|Device|STrategically Acquired Gradient Echo (STAGE)|The STAGE package uses conventional 3D gradient echo MR, its magnitude and phase, collected at set parameters which allow for the reconstruction of multiple MR datasets which results in decreased acquisition time, equivalency to conventional MR, and the decrease in scan time allows for a higher standard of wealth within the data acquired.
15819147|NCT04292288|Diagnostic Test|Biochemical observational|no intervention - observational
15819150|NCT04292262|Other|Observational|Observational
15819151|NCT04292249|Other|Blood sampling|Analysis will be performed using commercially available analyses (suPARnostic® kit (validated to measure suPAR concentrations between 0.6 and 22 ng/mL) (ViroGates)). HsCRP will be measured by high sensitivity CRP assays (Tina-quant hs-CRP latex assay (validated to measure CRP concentrations between 0.3 - 20 mg/L) (Roche/Hitachi)). In patients with CRP>20 mg/L a regular CRP-measurement will be performed.
15819152|NCT04292236|Dietary Supplement|Lauric Acid, Perilla Oil and Diindolylmethane|Colonic release capsules containing lauric acid (2400mg), perilla oil (2100mg) and diinodlylmethane (500mg) given to volunteers 1 hour prior to standardised breakfast and lunch meal. Placebo group given cellulose capsules of same volume prior to standardised breakfast and lunch meal.
15819153|NCT04292223|Drug|Pimavanserin|Pimavanserin 34 mg (provided as 1×34 mg capsule), administered orally, once daily for 16 weeks
15819154|NCT04292210|Device|Perisafe|A medical device simplifying the connection of tubing as well as breaking of the frangible which is done in a sterile environment with the help of levers and buttons.
15819155|NCT04292197|Drug|18-MC Compound|18-MC
15819156|NCT04292184|Drug|Seacalphyx (sodium thiosulfate pentahydrate injection BP) 25%|The kidney will have 100 mL of 500µM STS added directly to the existing pulsatile perfusion solution at 4°C.
15819157|NCT04292171|Drug|Gabapentin|Preoperative treatment with Gabapentin
15819158|NCT04292171|Drug|Placebos|Preoperative treatment with Placebo
15819159|NCT04292158|Device|SomnoTouch|"The patient will be equipped with the SomnoTouch device. This device is able to record and estimate the following data:
~ECG data PPG data Heart rate Respiration rate Blood pressure (mmHg) Oxygen saturation (%).
~All patient will be stored for further analysis."
15819160|NCT04292158|Device|MOX|"The patient will be equipped with the MOX device. This device is able to record and estimate the following data:
~Accelerometers data Activity Body posture
~All patient will be stored for further analysis."
15819161|NCT04292145|Behavioral|Relaxation Application|The use of an application for relaxation.
15819162|NCT04292145|Behavioral|Relaxation Only|The individual's personal method to relax.
15819163|NCT04292132|Procedure|Implant placement|interforaminal placement of 2 implants
15819164|NCT04292132|Procedure|immediate loading|immediate loading with a locator retained mandibular overdenture
15819165|NCT04292132|Procedure|conventional loading|conventional loading with a locator retained mandibular overdenture 3 months postoperatively
15819166|NCT04292119|Drug|Lorlatinib|"Lorlatinib will be taken orally once daily for 28 days when combined with crizotinib or binimetinib. Lorlatinib will be taken orally once daily for 21 days when combined with TNO155.
~Crizotinib taken orally twice daily for 28 days."
15819167|NCT04292119|Drug|Crizotinib|"Crizotinib will be taken orally twice daily for 28 days.
~Binimetnib taken orally twice daily for 28 days."
15819168|NCT04292119|Drug|Binimetinib|Binimetinib will be taken orally twice daily for 28 days.
15819169|NCT04292119|Drug|TNO155|TNO155 will be taken orally once daily for 14 days.
15819170|NCT04292106|Dietary Supplement|Red Spinach Extract (RSE)|Oral capsules containing 2g of Red Spinach Extract will be consumed daily for 7 days
15819171|NCT04292106|Dietary Supplement|Placebo|Oral placebo capsules will be taken consisting of maltodrextrin daily for 7 days
15819203|NCT04291833|Behavioral|Intervention group 2|Protein supplementation QD, Vitamin D and calcium supplementation Vitamin D 1000 IU / d, calcium 500mg/d, exercise 3 months
15819172|NCT04292093|Behavioral|Home rehabilitation training|The rehabilitation training will be provided via Lumosity platform. Participants will be asked to play computer video-games aimed at strengthening specific sub-functions pertaining to the macro area of executive functions for 30 minutes a day, 5 days a week, for a total of 8 weeks. Specifically, 20 games out of a total of 64 available games provided by the platform have been selected. The selected games are aimed at training 4 cognitive skills: memory, attention, cognitive flexibility and problem solving. In particular, 5 different games were chosen for each cognitive ability.
15819173|NCT04292093|Behavioral|Home control activity|The control group will watch a series of animated / TV shows suitable for the sample age, again for 30 minutes a day, 5 days a week, for 8 weeks. The videos will be provided by the experimenter and participants will watch them on their personal computer. At the end of each videos, participants will answer a series of multiple-choice questions aimed at evaluating the attention deployed to the content of the videos.
15819174|NCT04292080|Drug|Dimethyl Fumarate (TECFIDERA™)|Dimethyl fumarate is a white to off-white powder that is highly soluble in water with a molecular mass of 144.13, containing 120 mg or 240 mg of dimethyl fumarate The starting dose for TECFIDERA is 120 mg twice a day orally. After 7 days, the dose should be increased to the maintenance dose of 240 mg twice a day orally. Body weight, gender, and age do not require dosage adjustment.
15819175|NCT04292080|Other|No active : no treatment|30 patients will receive no specific treatment (standard of care) up to 24 months following randomization.
15819176|NCT04292067|Biological|Faecal sampling|Faecal sampling at baseline
15819177|NCT04292054|Drug|active intervention|The antibiotic prophylaxis will be cefazolin 2 g, or piperacilline-tazobactam 4 g, powder for solution for injection diluted in 50mL of NaCl 0.9%, IV infusion on 30 minutes with syringe pump.
15819178|NCT04292054|Other|placebo intervention|The control group will received, as placebo NaCl 0.9% solution for injection diluted in 50mL of NaCl 0.9%, IV infusion on 30 minutes with syringe pump.
15819179|NCT04292041|Other|Fasting mimicking diet|"3 cycles of programmed nutrition using a fasting mimicking diet (Chemolieve (R)), each cycle consisting of 4 days. Pre and post nutritional cycles, clinical and metabolic assessments are taken, as per protocol. Allowing for a 3 month washout time, the 'post' assessment is planned approximately 6 months from the initial (pre) assessment."
15819180|NCT04292028|Other|Pilates|The Pilates group participated in an 8-week clinical Pilates training program
15819181|NCT04292028|Other|Home exercises|Control group were given a home-based exercise program.
15819182|NCT04292015|Diagnostic Test|Optos ultra-widefield retinal imaging (Optos California)|retinal imaging device
15819183|NCT04292002|Behavioral|Test@Work|Offer of a general health check including opt-in sexual health consultation and HIV testing, weight/height, Body Mass Index (BMI), blood pressure, mental health screen. Provision of tailored health advice and a resource pack with information and signposting.
15819184|NCT04291989|Device|Optimal Blood Sampling Site for Point of Care Lactate Assessment using the handled Lactate-Pro 2 device|This study aims to compare lactate levels using the Lactate Pro 2 device from the same patient at the same time with blood samples taken from three locations - fingertip, earlobe and forearm venepuncture
15819185|NCT04291976|Procedure|Back-to-back high-definition white light endoscopy|Using HD white light, the entire colon is examined for dysplasia and other abnormalities after the caecum is reached, with a second segmental inspection after the first examination in the same session.The colonoscope has a high-definition camera and processor. All images are displayed on a high definition monitor for optimal resolution.
15819186|NCT04291976|Procedure|single-pass high-definition white light endoscopy|Using HD white light, the entire colon is examined for dysplasia and other abnormalities after the caecum is reached. The colonoscope has a high-definition camera and processor. All images are displayed on a high definition monitor for optimal resolution.
15819187|NCT04291976|Procedure|chromoendoscopy|After introduction of the endoscope into the colon a dye (methylene blue or indigo carmine) will be sprayed through a catheter positioned into the biopsy channel. Per segment, the entire colon is dyed, inspected, and lesions are removed. Equipment is similar to the other two interventions.
15819188|NCT04291963|Procedure|DGG + TUN|In the DGG group, CTG was obtained at palatal mucosa by means of intra-oral de-epithelialization of the FGG using a 2.3 mm diameter diamond burr (801G/023, EMS, Aldrich Co., USA) with NaCL 0.9% saline irrigation
15819189|NCT04291963|Procedure|SCTG + TUN|In SCTG group, graft was harvested through the single-incision approach at palatal mucosa
15819190|NCT04291950|Procedure|Needle core biopsy|"Blood draws will be done in OR by research staff. Tissue will be obtained at the time of their definitive surgery or at the time of port placement. For women going to surgery first, four (4) 16-gauge core needle biopsies will be obtained by research staff after the tumor has been removed from the patient and the specimen is on the collection table in the OR.
~For women who are getting neo-adjuvant therapy prior to surgery, the core needle biopsies will be collected at the time of port placement in the OR. The patient will be under light anesthesia for the port placement. Per standard care, we will also use local anesthetic for the needle core biopsy. Port placement requires ultrasound (US). We will take advantage of the US already available in the OR to guide the core needle biopsy. Within 30 minutes of procurement, the tissue from the biopsies will be flash frozen in liquid nitrogen by staff and taken to the lab."
15819191|NCT04291937|Drug|Lurbinectedin|Powder for concentrate for solution for infusion in 4 mg vials
15819192|NCT04291924|Diagnostic Test|Dynamometry|A test for maximal muscle strength and explosive power in the lower limbs
15819193|NCT04291898|Device|AMPLATZER™ Septal Occluder.|Implantation of the AMPLATZER™ Septal Occluder in the ASD.
15819194|NCT04291898|Device|Occlutech Figulla Flex II®|Implantation of the Occlutech Figulla Flex II® in the ASD.
15819195|NCT04291898|Device|GORE® CARDIOFORM ASD Occluder|Implantation of the GORE® CARDIOFORM ASD Occluder in the ASD.
15819196|NCT04291885|Drug|Avelumab|Avelumab IV infusion
15819197|NCT04291885|Drug|Placebo|Placebo IV infusion
15819198|NCT04291872|Other|Glass -Ionomer Cement with /without Led Light Cure|Teeth were restored as same protocole with non-Heated Group. LED light (GC- D-Light DUO) was used at standard mode 1200 mW/cm2, at 50-60 ºC, for 60 sec.
15819199|NCT04291859|Drug|Lu AF28996|capsule, orally, doses and dose escalation scheme will be decided upon at dosing conferences
15819200|NCT04291846|Drug|SHR1459 fasted in P1, high-fat diet in P2|SHR1459 administration in fasted condition in period 1, SHR1459 administration after high-fat diet in period 2
15819205|NCT04291820|Procedure|Intravenous induction and desflurane anaesthesia maintenance|Anaesthesia will be inducted with intravenous propofol + opioid and maintained with desflurane according to the BIS levels
15819206|NCT04291820|Procedure|Inhalation induction with sevoflurane and anaesthesia maintenance with sevoflurane|Anaesthesia will be inducted with sevoflurane and maintained with sevoflurane according to the BIS levels
15819207|NCT04291807|Behavioral|Video education|Procedure was presented to the cases via a video showing the steps in ERCP and questions had been answered by an experienced nurse
15819208|NCT04291794|Drug|Propofol|2mg/kg single bolus
15819209|NCT04291794|Drug|Propofol Injection [Diprivan]|Tritiated Target-Controlled Infusion
15819210|NCT04291781|Biological|RC18 160mg|subcutaneous injection RC18 160mg on the upper arm, abdomen, or upper thigh outside;
15819211|NCT04291781|Biological|RC18 240mg|subcutaneous injection RC18 240mg on the upper arm, abdomen, or upper thigh outside;
15819212|NCT04291781|Biological|placebo|subcutaneous injection placebo on the upper arm, abdomen, or upper thigh outside;
15819213|NCT04291768|Other|Shortened antibiotic treatment|Shortened antibiotic treatment of 5 days. Participation in the study will only affect treatment duration and will have no influence on the choice of treatment in respect to type and dose of antibiotic treatment.
15819214|NCT04291768|Other|Standard antibiotic treatment|Standard antibiotic treatment of minimum 7 days at the discretion of treating physician. Participation in the study will only affect treatment duration and will have no influence on the choice of treatment in respect to type and dose of antibiotic treatment.
15819215|NCT04291755|Drug|Pembrolizumab Injection|Any checkpoint inhibitor is acceptable
15819216|NCT04291742|Diagnostic Test|cognitive vs software|cognitive vs software
15819217|NCT04291729|Drug|Ganovo+ritonavir+/-Interferon nebulization|Ganovo one tablet (100mg / tablet) at a time, twice a day, up to 14 days. Ritonavir one tablet(100mg / tablet) at a time, twice a day, up to 14 days.With or without spray inhalation of interferon, 50μg / time for adults, twice a day up to 14 days.
15819218|NCT04291716|Device|Motor Seizure Detection Algorithm (mSDA)|A seizure detection algorithm installed on a propriety mobile application to be used on a commercially available watch with a gyroscope to detect movement.
15819219|NCT04291703|Drug|Antithymocyte Globulin|Thymoglobulin
15819220|NCT04291703|Drug|Placebo (for ATG)|Normal Saline administered by IV infusion to mimic ATG
15819221|NCT04291690|Other|Physical Component of the Intervention|We will encourage and assist patients to walk around the ward as tolerated and approved by their treating clinicians, to maximize the time spent out of bed, minimize the time spent in bed, and to encourage and assist them to perform chair rises to build lower extremity strength. For selected intervention patients with greater physical weakness, defined as SPPB ≤9, a Certified Exercise Physiologist will administer a supervised multicomponent exercise program combining strength, flexibility, balance and gait for the prevention of weakness and falls. The exercise program is adapted from the Vivifrail program which is an EU-funded initiative that provides a guide to prevent frailty, physical deconditioning, and incident disability in older persons. The program includes two daily sessions, one in the morning and one in the afternoon, for a duration of 20 minutes each. The morning session includes strength and flexibility exercises. The afternoon session targets balance and walking.
15819222|NCT04291690|Other|Cognitive Component of the Intervention|We will encourage and assist them to wear their hearing and visual aids (if they have these), orient them to time and place verbally and in writing on a clearly visible white-board in their hospital room - and also encourage their family members and caregivers to do so on a regular basis, and inquire about their sleep quality and communicate with the clinical team to reduce sleep disturbances. For selected intervention patients with greater cognitive impairments, defined as MMSE ≤26, we will provide cognitive simulation twice daily during the scheduled visits. Cognitive stimulation comprises of activities with the patient, including but not limited to current news, trivia, crossword puzzles, and memory games. These cognitive interventions are adapted from the Hospital Elder Life Program (HELP) that targets risk factors for delirium.
15819223|NCT04291690|Other|Nutritional Component of the Intervention|We will reinforce proper eating habits, encourage and assist patients to wear their dentures (if they have these), and inquire about their food preferences and eating barriers and communicate with the clinical dieticians to address these issues. For selected intervention patients with greater nutritional deficits, defined as a positive PONS, we will recommend to the treating clinicians to prescribe MedPass supplementation. PONS, developed as a preoperative screening tool but also used in nonoperative medical settings, reflects low body mass index, weight loss, low dietary intake, and albumin level. MedPass is a 60 mL calorically dense (2 kcal/mL) oral nutritional supplement consumed between meals 4 times per daily. If MedPass supplementation is contraindicated, the treating team will have the full discretion not to prescribe it and/or to consider alternative supplementation strategies.
15819224|NCT04291690|Other|Iron-Deficiency Anemia (IDA) Component of the Intervention|We will verify their clinical blood test results for hemoglobin level and iron studies and apply the diagnostic criteria for iron deficiency as recommended by the Canadian Cardiovascular Society Guidelines for Heart Failure. These criteria are: (i) Hemoglobin <130g/L in men or <120g/L in women with (ii) a Ferritin <100μg/L or a Ferritin <300μg/L with a Saturation <20%. For selected intervention patients with diagnosed iron deficiency anemia, according to these established criteria, we will recommend to the treating clinicians to prescribe Venofer intravenous iron replacement therapy. The use of intravenous iron replacement therapy is a Strong Recommendation in the Canadian Cardiovascular Society Guidelines. Venofer is prescribed at a dosage of 300 mg IV daily for a total of 3 doses. If Venofer supplementation is contraindicated, the treating team will have the full discretion not to prescribe it and/or to consider alternative strategies.
15819225|NCT04291677|Other|intervention musical|Intervention group in which musical intervention will be applied the first or third day of mechanical ventilation.
15819226|NCT04291677|Other|Without intervention musical|Control group with standard treatment without musical intervention.
15819227|NCT04291664|Drug|Abiraterone Acetate|Abiraterone Acetate 1000mg will be administered orally once daily
15819228|NCT04291664|Drug|Prednisone 5Mg Tab|"Prednisone 5mg will be administered orally twice daily with Abiraterone Acetate 1000mg
~Prednisone 5mg will be administered orally twice daily with DST-2970 for 28 days after dosing of Abiraterone Acetate is stopped"
15819229|NCT04291664|Drug|DST-2970 (Abiraterone)|DST-2970 will be administered orally twice daily for 28 days (for every cycle) after dosing of Abiraterone Acetate is stopped
15819230|NCT04291651|Other|Survey|There are no study-specific interventions, as this is a prospective registry. However, patients will be asked to complete approximately 1-2 hours worth of surveys on things such as demographics, medical and surgical history, and pancreatic cyst-specific questionnaires.
15819231|NCT04291638|Behavioral|Remote Caregiver Training|The remote caregiver training is a 5-hour videoconferencing-based training program that focuses on teaching cognitive behavioral therapy skills to the caregivers of children with selective mutism in a group format across 3 sessions.
15819232|NCT04291638|Behavioral|Remote Intensive Group Behavioral Treatment (IGBT)|The remote IGBT is a 5-day videoconferencing-based treatment program that delivers cognitive behavioral therapy to children and their caregivers in a group format across 2-3 hours per day.
15819233|NCT04291625|Procedure|Levator muscle resection|"Surgery was performed under general anaesthesia. Two milliliters of 2% lidocaine with 1:100 000 epinephrine is injected subcutaneously. After the upper eyelid incision at the desired crease line, the orbital septum was opened and the preaponeurotic fat was identified and dissected off the levator aponeurosis. The aponeurosis was disinserted from the tarsus, and the complex of levator aponeurosis and Muller muscle was dissected free from the conjunctiva. The desired eyelid height was determined from the proposed formula.
~Satisfactory Intraoperative lagophthalmos was defined as a difference of less than 1 mm between recommended by the formula and actual intraoperative lagophthalmos.
~After permanent fixation, a caliper was used for precise measurement of lagophthalmos in a supine position. Additional sutures were placed on the medial and lateral sides for satisfactory eyelid contour. The redundant levator complex was excised. Eyelid crease was made by placing three interrupted sutures"
15819234|NCT04291612|Other|Physical exam|Part 2 participants will be prospectively followed clinically for relapse for 30 months from the date of surgery for physical examination at post-ops visits.
15819235|NCT04291599|Drug|Ketorolac|Subjects will be randomized to either receive opioid (standard of care) or opioid-sparing analgesia.
15819236|NCT04291599|Drug|Opioid|Subjects will be randomized to either receive opioid (standard of care) or opioid-sparing analgesia
15819237|NCT04291586|Other|Virtual reality|Virtual Reality Intervention of 30 minutes, 3 times a week until reaching 24 sessions.
15819238|NCT04291586|Other|Paper and Pencil|Paper and Pencil Intervention of 30 minutes, 3 times a week until reaching 24 sessions.
15819239|NCT04291573|Device|HD-tDCS|Real stimulation (2mA, 20min) with anode on C3/C4 of the lesioned hemisphere and 4 return electrodes ~4cm away
15819240|NCT04291573|Device|Sham HD-tDCS|Sham stimulation (2mA, ramp up and down phases of 30s) with anode on C3/C4 of the lesioned hemisphere and 4 return electrodes ~4cm away
15819241|NCT04291560|Behavioral|Stretching Exercise Intervention|Sequential static stretching of the large skeletal muscle group 5 days per week. Each skeletal group is stretched for 20 seconds for 3 repetitions.
15819242|NCT04291547|Device|BALM|An online Behavioural Activation programme for young people with mild to moderate low mood/depression. The programme comprises 10 treatment sessions lasting 30 to 45 minutes
15819243|NCT04291521|Drug|Ketamine|Administering ketamine as an induction medication for intubating adult trauma patients within 24 hours of hospital admission.
15819244|NCT04291521|Drug|Etomidate|Administering etomidate as an induction medication for intubating adult trauma patients within 24 hours of hospital admission.
15819245|NCT04291521|Drug|Propofol|Administering propofol as an induction medication for intubating adult trauma patients within 24 hours of hospital admission.
15819246|NCT04291508|Drug|Intravenous Acetaminophen (room temperature)|Acetaminophen given intravenously at the dose of 1 gram (or 15 mg/kg if patient weighs < 50 kg) every six hours for 5 days (20 doses)
15819247|NCT04291508|Drug|Intravenous Vitamin C (refrigerated)|Vitamin C given intravenously at the dose of 50 mg/kg every six hours for 5 days (20 doses)
15819248|NCT04291508|Drug|5% Dextrose (room temperature)|Placebo (identical appearing room temperature 5% dextrose solution) infused every six hours for 5 days (20 doses)
15819249|NCT04291508|Drug|5% Dextrose refrigerated|Placebo (identical appearing refrigerated 5% dextrose solution) infused every six hours for 5 days (20 doses)
15819250|NCT04291495|Diagnostic Test|ANDROSITOL®TEST|Sperm incubation with ANDROSITOL®DGN and evaluation of sperm motility and mithocondrial membrane potential
15819251|NCT04291482|Behavioral|Choosing Health Intervention|The intervention consists of information materials provided at baseline in a form of eBook or a physical book depending on participants preferences. The book includes the rationale for the intervention, basic information on healthy eating and behaviour change and tables allowing self-monitoring of weight, physical activity and eating (i.e., brief food diary). The book is non-tailored and it has weekly tasks for the participants to complete during 26 weeks (initial 6 months) to support their weight loss. The intervention group will also receive a series of daily text messages and weekly email messages supporting their weight loss and promoting weight loss maintenance. In phase I (month 0-3), the messages and emails will be generic and factual; in the phase II of the intervention, participants will receive text messages and emails tailored to the strongest predictors of outcomes identified in phase I.
15819252|NCT04291482|Behavioral|Choosing Health Control|The control consists of information materials provided at baseline in a form of eBook or a physical book depending on participants preferences. The book includes the rationale for the intervention and basic information on healthy eating and physical activity. The control group will also receive monthly email messages with generic and factual information.
15819253|NCT04291469|Drug|Probiotics（Live combined bifidobacteria, lactobacillus and maltodextrin tables)|The probiotic compound will consist of tables containing approximately 10^9 colony forming units of the probiotic organisms, Lactobacillus and Bifidobacteria lactis strain，mixed maltodextrin(oral, daily for 14 weeks).
15819254|NCT04291469|Dietary Supplement|Prebiotics (Combined inulin and maltodextrin tables)|The prebiotic compound will consist of tables containing inulin and maltodextrin (oral,daily for 14 weeks)
15819255|NCT04291469|Dietary Supplement|maltodextrin|Maltodextrin tables (oral,daily for 14 weeks)
15819256|NCT04291456|Drug|Minocycline 100mg|Single-arm trial of minocycline 100 mg twice daily
15819257|NCT04291443|Procedure|Heavy Force (225g)|Orthodontic Force
15819258|NCT04291443|Procedure|Light Force (25g)|Orthodontic Force
15819259|NCT04291417|Diagnostic Test|CBC-DIFF Monocyte Volume Width Distribution (MDW)|MDW measurement used to detect sepsis. Results will not be used to manage patients.
15819260|NCT04291404|Device|Virtual Reality Distraction|Distraction therapy using a Virtual Reality (VR) device
15819261|NCT04291391|Other|North American Diet|standardized North American/Canadian diet for 4 weeks designed to reflect (as closely as possible) current macronutrient intake averages in North America/Canada (35% of energy as fat, 12.5% as saturated fat, 13% as monounsaturated fat, 6% as polyunsaturated fat, 48% as carbohydrate, 17% as protein)
15819262|NCT04291378|Radiation|Proton versus photon radiation therapy|The intervention is proton radiation therapy versus photon radiation therapy
15819263|NCT04291365|Diagnostic Test|Blood pressure measurement|Study subjects will have a total of 9 blood pressure measurements taken (3 on upper arm, 3 on lower arm, and 3 on wrist)
15819264|NCT04291352|Dietary Supplement|Taurine|675mg taurine four times daily
15819265|NCT04291352|Other|Placebo|placebo four times daily
15819266|NCT04291339|Procedure|High-flow nasal oxygen technique|High-flow nasal oxygen will be applied to the patients through nasal openings using Optiflow system during anesthetic induction. Pulse oximetry and oxygen reserve index will be monitored continuously.
15819267|NCT04291339|Procedure|Mask ventilation technique|Oxygen will be supplied through the mouth and nose to the patients using facial mask during anesthetic induction. Pulse oximetry and oxygen reserve index will be monitored continuously.
15819268|NCT04291326|Diagnostic Test|Transfontanelle ultrasound|cerebral blood flow measurement using transfontanelle ultrasound
15819269|NCT04291313|Dietary Supplement|Vitamin D3 (90µg)|The intervention is a higher dose of vitamin D than what is currently recommended to Danish pregnant women
15819270|NCT04291313|Dietary Supplement|Vitamin D3 (10µg)|This intervention serves as a control as they get the current recommended vitamin D dose
15819271|NCT04291300|Drug|Lutetium-177-PSMA-I&T|4 cycles of 7.4 GBq 177Lu-PSMA every 6 weeks.
15819272|NCT04291287|Drug|Antithrombotic Agent|"Adenosine diphosphate (ADP) receptor antagonists (or P2Y12 inhibitors) therapy include:
~Clopidogrel (Plavix®)
~Prasugrel (Efient®)
~Ticagrelor (Brilique®)
~DOACs therapy include:
~Apixaban (Eliquis®)
~Dabigatran (Pradaxa®)
~Edoxaban (Lixiana®)
~Rivaroxaban (Xarelto®).
~Oral anticoagulant therapy (OAT) include:
~Warfarin (Counmadin®)
~Acenocumarol (Sintrom®)"
15819273|NCT04291261|Drug|Uvadex|Extracorporeal photopheresis (ECP) with Uvadex is scheduled 3x/week in weeks 1+2, 2x/week thereafter till day 28 and 1x/week till day 56
15819274|NCT04291248|Drug|AK105|AK105 is a humanized monoclonal antibody that specifically binds to PD-1. AK105 has a typical antibody structure and is composed of two lgG1 subtype heavy chains and two kappa subtypes light chains covalently linked by disulfide bonds.
15819275|NCT04291248|Drug|Anlotinib|A multi-target receptor tyrosine kinase inhibitor.
15819276|NCT04291235|Procedure|Airway Management Pathway|Patients in this group will receive several components that comprise airway management pathway: (1) daily spontaneous breathing trials (SBTs); (2) prompt extubation following successful extubation readiness criteria; (3) high-flow nasal oxygen for at least 24 hours following extubation.
15819277|NCT04291235|Procedure|Usual Care|Patients in this group will be treated according to usual care, which may include extubation or tracheostomy timed according to treating physicians' discretion.
15819278|NCT04291222|Device|Iron biocorrodable coronary scaffold system|Implantation of Iron biocorrodable coronary scaffold system
15819279|NCT04291209|Drug|N-Acetyl Cysteine|One ear will be randomly chosen for the experimental treatment of intratympanic NAC. The other ear will serve as the control ear which will not receive any injection.
15819280|NCT04291196|Other|VR-ECT 360o Video|Patients in the VR arm will be immersed in the ECT process in first person utilizing Google Cardboard headsets. Patients will experience in 360 entering the procedure room, IV insertion, pretreatment checks, anesthetic induction followed by induction of seizure, and recovery. The experience will also have voice-over narration simultaneously describing the procedure and its risks and benefits.
15819281|NCT04291196|Other|Standard Treatment|Patients will receive preparation for their ECT as per standard of care, i.e. a discussion with a Psychiatrist.
15819282|NCT04291183|Behavioral|horticultural therapy|Flowers and vegetables will be planted with the elderly. Growth of plants planted with the elderly will be observed and maintained
15819283|NCT04291170|Other|QDASH|completing the tasks on the QDASH: open jar, wash wall, carry shopping bag, wash back, cut food, hammer wood
15819284|NCT04291170|Other|KOOSJR|completing tasks on the KOOSJR: pivot, straighten, go up/down stairs, stand upright, rise from sitting, bend over
15819285|NCT04291157|Other|CVD risk estimation incorporating the PRS and guideline based preventive interventions.|Total CVD risk estimation using SCORE plus PRS and European Society of Cardiology (ESC) CVD prevention guideline based interventions.
15819286|NCT04291157|Other|Standard GP care|Usual GP care (opportunistic CVD prevention)
15819287|NCT04291144|Radiation|PET-CT using FEOBV|We will inject 300 MBq of 18F-FEOBV in a peripheral vein and scan the internal organs from (0-70 minutes). The patient then rests, and from 180-210min after injection, we will scan the brain on our Siemens High Resolution Research Tomograph.
15819288|NCT04291144|Radiation|MRI-scan|All patients will have an MRI scan of the brain. T1-weighted images will be used to assess general anatomy and identify white matter. T2-weighted sequences will be performed to quantify competing brain pathology. Also, we will collect functional MRI data.
15819289|NCT04291144|Diagnostic Test|Cognitive assessment|Full neuropsychometric examination including tests in 5 cognitive domains.
15819290|NCT04291144|Diagnostic Test|Clinical assessment|Age, sex, duration of disease, patient history and full somatic and neurological examinations. Constipation assessed with Rome-III criteria. Evaluation of Rapid Eye Movement (REM) sleep Behaviour Disorder (RBDSQ) questionnaire. Test for orthostatic hypotension, heart rate variability, and deep breathing.
15819291|NCT04291118|Procedure|Private system endoscopic sinus surgery|Patients that will undergo endoscopic sinus surgery though the private system. Beforehand they could of used medical management including, budesonide for their symptoms.
15819292|NCT04291118|Procedure|Public system endoscopic sinus surgery|Patients that undergo endoscopic sinus surgery though the public system after waiting for at least 1 year. Beforehand they could of used medical management, including budesonide for their symptoms.
15819293|NCT04291118|Drug|Budesonide|Patients will receive medical management for their symptoms that will consist of topical nasal steroid, budesonide and any other required medication for their disease.
15819294|NCT04291105|Biological|VV1|VV1 is to be administered on Day 1
15819295|NCT04291105|Biological|Cemiplimab|Cemiplimab should be given on Day 1 of each 21-day cycle for up to 2 years
15819300|NCT04291079|Biological|anti-PD-(L)1 antibody therapy|approved anti-PD-(L)1 antibody therapy for each tumor type
15819301|NCT04291066|Drug|N-Acetyl cysteine|Carbonyl scavenger and multi-vitamins with minerals to neutralize reactive carbonyl groups on the lipid aldehydes in patients with TBI
15819302|NCT04291053|Drug|Huaier Granule|standard treatment + Huaier Granule 20g po tid for 2weeks
15819303|NCT04291040|Behavioral|Decision Aid|Following randomization, participants will independently view the multimedia based decision aid on a provided tablet. They will also receive provider counseling. For the remainder of the pregnancy, they will receive a text message with a link to the multimedia based presentation. This will occur every 4 weeks until 12 weeks postpartum.
15819304|NCT04291040|Behavioral|Routine Care|The control arm will receive routine prenatal care including provider counselling on postpartum contraceptive options.
15819305|NCT04291027|Other|Land Based Exercise|Group exercise intervention will be held 2 times per week for 12 weeks and will include balance training, strengthening, gait training, and cardiovascular training.
15819306|NCT04291027|Other|Aquatic Exercise|Group exercise intervention will be held 2 times per week for 12 weeks and will include balance training, strengthening, gait training, and cardiovascular training.
15819307|NCT04291014|Device|SunRay Light Boxes|SunRay light boxes will be used to administer the light therapy.
15819308|NCT04291001|Device|ENG implant|This is an FDA-approved contraceptive device
15819309|NCT04291001|Drug|oral ulipristal acetate|This is an FDA-approved oral emergency contraceptive
15819310|NCT04290988|Device|EEG Neurofeedback|Active EEG neurofeedback
15819311|NCT04290988|Device|Sham Feedback|Sham EEG feedback sessions identical to active sessions except that the feedback given to the participant will not be based on the individual's live EEG activity.
15819312|NCT04290975|Other|Task-shifting of follow-up care for pediatric epilepsy|For the intervention arm, follow-up care of children with epilepsy will be shifted to be performed primarily by Community Health Workers (CHWs) with specialized epilepsy training
15819313|NCT04290975|Other|Enhanced usual care for pediatric epilepsy|For the intervention arm, follow-up care of children with epilepsy will be performed primarily by physicians, with CHWs serving to collect standardized data regarding outcomes
15819314|NCT04290962|Behavioral|Lifestyle Therapy|Complete web-based lifestyle intervention
15819315|NCT04290962|Other|Quality-of-Life Assessment|Ancillary studies
15819316|NCT04290962|Other|Questionnaire Administration|Ancillary studies
15819317|NCT04290936|Drug|Vemlidy® (Tenofovir Alafenamide; TAF)|Dosage form: Oral Tablets; Dosage: 25mg; Frequency: One tablet with meals, once daily(QD).
15819318|NCT04290936|Drug|Placebo|Dosage form: Oral Tablets; Dosage: N/A; Frequency: One tablet with meals, once daily(QD).
15819319|NCT04290910|Behavioral|Weight Loss Program|There are three components of the intervention, this includes: psychology, nutrition, and physical activity. For the psychological portion, a therapist will assess the participant at baseline to determine if there are barriers associated with making lifestyle changes. For nutrition, the dietitian will assess the participant and create a meal plan based on their nutritional needs and guide the participant to reaching their nutritional goals. The psychological and nutrition portion may be interchangeable depending on the participants needs. For physical activity, the personal trainer will assess the participant and create an exercise plan that consists of resistance training and weight bearing exercises suitable for the participant while also guiding the participant to reach their exercise goals.
15819320|NCT04290897|Drug|Anhydrous Enol-oxaloacetate|Given PO
15819321|NCT04290897|Other|Questionnaire Administration|Ancillary studies
15819322|NCT04290884|Drug|Tranexamic Acid|The recruited patients will be randomly assigned to two groups, 50% chance to the experimental group (use of tranexamic acid) and 50% chance to the control group (use of normal saline). After the reduction of the intertrochanteric fracture, 10ml of tranexamic acid is injected under the deep fascia around the fracture area before inserting a drain. As for the control group, 10ml of normal saline is injected instead. Blood will be taken on the third day post operation, and the patient will be seen at 6 weeks, and 3 months.
15819323|NCT04290871|Drug|Nitric Oxide Gas|Inspired NO will be delivered at 80 parts per million (ppm) in the first 48 hours of enrollment. After that, NO levels will be decreased to 40 ppm until severe hypoxia resolves. Weaning from NO will start when patients improves the level of oxygenation to a PaO2/FiO2 > 300 mmHg or SpO2 > 93% for more than 24 hours consecutively. Physician will follow their own institutional weaning protocols. In the absence of institutional protocols, NO will be reduced every 4 hours in step-wise fashion starting from 40 ppm to 20, 10, 5, 3, 2 and 1 ppm.
15819324|NCT04290858|Drug|Nitric Oxide|Nitric Oxide (NO) will be delivered together with the standard of care for a period of 20-30 minutes 2 times per day for 14 consecutive days from time of enrollment. Targeted concentration will have a tidal oscillation between 100 and 300 ppm, in order to maintain an average inhaled concentration from 140 to 180 ppm. The gas will be delivered through a CPAP circuit ensuring an end-expiratory pressure between 2 and 10 cmH2O or trough a non-rebreathing mask without positive end expiratory pressure, depending on the clinical needs of the patient.
15819325|NCT04290845|Behavioral|Relief-Hybrid|A 9-week behavioral intervention for primary care patients designed to reduce depression and pain-related disability.
15819326|NCT04290832|Behavioral|CO Intervention|"South Africa: Values clarification and attitude transformation (VCAT) workshop with conscientious objection content, debrief session(s) with termination of pregnancy (TOP) providers to give them an opportunity to share concerns/challenges, meeting(s) with facility mangers to facilitate continued support and provision of TOP care
~Mexico: Training on abortion and conscientious objection law, posters on law, offer of legal assistance for abortion providers, scholarship to attend conference awarded on basis of quality of abortion care"
15819327|NCT04290819|Dietary Supplement|Creatine Monohydrate|0.1g/kg of body weight (pre measured creatine) and 3mg/kg of body weight (pre measured micronized cellulose powder-caffeine placebo) self administered 1 hr prior to working out mixed in water.
15819328|NCT04290819|Dietary Supplement|Creatine Monohydrate and Caffeine|0.1g/kg body weight (pre measured creatine) and 3mg/kg body weight (pre measured caffeine) self administered 1hr prior to working out mixed in water.
15819329|NCT04290819|Dietary Supplement|Caffeine|3mg/kg of body weight (pre measured caffeine) and 0.1g/kg of bodyweight (pre measured maltodextrin- creatine placebo) self administered 1 hr prior to working out mixed in water.
15820144|NCT04283656|Drug|Spironolactone 100mg|200mg orally for two doses, twice-daily
15819330|NCT04290819|Dietary Supplement|Placebo|0.1g/kg of body weight (pre measured maltodextrin) and 3mg/kg of body weight (pre measured micronized cellulose powder) self administered 1 hr prior to working out mixed in water.
15819331|NCT04290806|Other|Routine care as per site standard|Physician's choice according to patient's needs. Routine care as per site standard.
15819332|NCT04290793|Drug|Pyrotinib|400mg administered as continuous oral once daily from the first day of the study
15819333|NCT04290793|Drug|Epirubicin|90mg/m^2 d1 iv Q2W for 4 cycles
15819334|NCT04290793|Drug|Cyclophosphamide|600 mg/m^2 d1 iv Q2W for 4 cycles
15819335|NCT04290793|Drug|Taxanes|Albumin paclitaxel（125mg/m2 d1、8 iv Q3W for 4 Cycles）/Docetaxel(100mg/m2 d1 iv Q3W for 4 Cycles )
15819336|NCT04290793|Biological|Trastuzumab|the first cycle is a loading dose of 8 mg / kg, followed by 6 mg / kg. Iv Q3W for 1 year
15819337|NCT04290780|Other|nosocomial infection/hospital acquired infection|"When there is suspicion of a community-acquired case (admission of an infected patient) or nosocomial case (infection of a patient already hospitalized), a case report form including demographic data, medical history, and clinical and biological data on the infectious episode will be completed for each case, either patient, caregivers or health care professionals, presenting clinical signs or symptoms compatible with SARS-CoV-2 infection. The suspected cases will undergo nasopharyngeal swab collection and detection of SARS-CoV-2 in nasopharyngeal swabs will be done by real-time RT-PCR assay.
~Hygiene measures applied by the service will be collected using a questionnaire as well as recommendations of the learned societies within the country regarding the risk of infection by coronavirus. In addition, data characterizing the service and hospital will also be collected (specialty, number of beds, number of nurses, doctors, etc.)."
15819338|NCT04290767|Diagnostic Test|Sulphur hexafluoride microbubbles SONOVUE (BRACCO, Milan, Italy)|Enhanced-contrast brain ultrasound with intravenously sulphur hexafluoride microbubbles SONOVUE (BRACCO, Milan, Italy) injection and using the time-intensity curve profile to evaluate brain microcirculation.
15819339|NCT04290754|Behavioral|CATCH-IT|Competent Adulthood Transition with Cognitive-behavioral & Interpersonal Training (CATCH-IT) is an internet-based depression prevention program that targets decreasing modifiable risk factors while enhancing protective factors in at-risk adolescents, and that includes a parent program. It has been shown to be safe, feasible, and efficacious.
15819340|NCT04290754|Behavioral|TEAMS|Teens Achieving Mastery over Stress (TEAMS) is an 8-session group depression prevention program teaching teens how to deal with stress and negative moods, and ways to manage low mood based on cognitive behavioral therapy (CBT) principles and strategies. Efficacy has been demonstrated by several trials over time.
15819341|NCT04290741|Procedure|Auricular (Battlefield) Acupuncture|Placement of needles based on battlefield acupuncture protocol which includes up to 5 sites on each ear to treat pain.
15819342|NCT04290741|Procedure|Peripheral Acupuncture|Placement of needles in up to 30 specific sites in the head, neck, arms from the shoulders to the hands, and legs from the knees to the feet
15819343|NCT04290728|Device|Apnea with high-flow nasal cannula|Application of oxygenation with high-flow nasal cannula with a rate of 2L/kg/min
15819344|NCT04290728|Other|Apnea|Apnea without any application of oxygenation
15819345|NCT04290715|Other|no intervention|no intervention
15819346|NCT04290702|Procedure|regional analgesia for labor|three commonly used regional analgesic techniques are used, with local anesthetic ropivacaine, opioid fentanyl, parturient controlled epidural analgesia
15819347|NCT04290689|Drug|Botulinum Toxin-A injection|Botulinum Toxin-A injection to be administered by the surgeon to the subject's calf muscle as per normal clinical protocol to help improve muscle tone.
15819348|NCT04290689|Procedure|Serial casting stretching|Stretching cast intervention to be carried out in clinic as per normal clinical protocol.
15819349|NCT04290676|Drug|DEXYCU (dexamethasone intraocular suspension) 9%.|DEXYCU contains dexamethasone 9% w/w (103.4 mg/mL) as a sterile suspension for intraocular ophthalmic administration. DEXYCU is provided as a kit for administration of a single dose of 0.005 mL of 9% dexamethasone (equivalent to 517 micrograms of dexamethasone).
15819350|NCT04290663|Drug|Systematic RAI-treatment|Administration of 3.7 GBq (100 mCi) of I131 after rhTSH-stimulation
15819351|NCT04290663|Other|Decision of RAI-treatment guided by a post-operative assessment|"The decision-making for the administration of an adapted RAI-treatment will be taken according to the following criteria:
~No RAI treatment if Tg/LT4 ≤1 ng/mL and rhTSH-sTg ≤10 ng/mL and normal diagnostic RAI-scintigraphy
~1.1 GBq after rhTSH if Tg/LT4>1 ng/mL or rhTSH-sTg>10 ng/mL and normal diagnostic RAI-scintigraphy.
~3.7 GBq after rhTSH if metastatic lymph-node(s) detected on diagnostic RAI-scintigraphy without distant metastasis
~3.7 GBq after hormone withdrawal if distant metastasis detected on diagnostic RAI-scintigraphy or on the hybrid CT scan of the SPECT-CT acquisition"
15819352|NCT04290650|Behavioral|Modified CBT for insomnia|Nurses who are working closely with the patients around the clock will perform an adjusted and modified version of CBT for sleep disturbances, in addition to standard evidence based treatment for psychosis and affective disorders as per today.
15819353|NCT04290650|Behavioral|Treatment as usual|All patients on the two other psychosis wards will receive standard evidence based treatment for psychosis and affective disorders as per today.
15819354|NCT04290637|Other|Cold-water sea swimming|Continue sea swimming for 4-6 weeks
15819355|NCT04290637|Other|No cold-water sea swimming|Discontinue sea swimming for 4-6 weeks
15819356|NCT04290624|Other|Experimental Dentifrice: Stannous Fluoride|Participants will be instructed to dose the toothbrush provided with a strip of dentifrice (a full brush head) on each brushing occasion containing 0.454% w/w Stannous fluoride for 2 minutes twice daily (morning and evening) for 12 weeks.
15819357|NCT04290624|Device|COREGA Denture Foaming Cleanser|Participant will clean their denture using 2 pumps of the denture cleansing foam and a denture cleaning brush for 90 timed seconds outside of the mouth twice daily (morning and evening) for 12 weeks.
15819358|NCT04290624|Other|Mouth rinse: Sodium Fluoride|Participants will take 10 ml of the mouth rinse containing 90 ppm sodium fluoride and swished around the mouth for 1 minute twice daily (morning and evening) for 12 weeks.
15819359|NCT04290611|Drug|Enzalutamide|Enzalutamide for the treatment of prostate cancer or other solid tumors
15819360|NCT04290585|Other|Questionnaire Administration|Ancillary studies
15819361|NCT04290585|Behavioral|Telephone-Based Intervention|Receive text message reminders
15819362|NCT04290572|Drug|Isotretinoin capsules|Jelly capsules of isotretinoin
15819363|NCT04290559|Procedure|Reveal LINQ ILR implant before AF ablation|Patients will undergo insertion of a LINQ ILR before the atrial fibrillation ablation performed according to standard clinical practice.
15819364|NCT04290546|Drug|Interleukin-15 Superagonist (N-803)|"-- Starting the day after (Cycle 1, Day +1) CIML NK-enriched cell infusion, at least 12 hours after CIML NK cell infusion is completed and up to 48 hours after CIML NK cell infusion, each participant will receive N-803 dosed at 15 mcg/kg subcutaneously every 21 days for 4 total doses (a cycle being every 21-days, so 4 cycles).
~N-803 dosed at 15 mcg/kg subcutaneously every 21 days for 4 total doses (a cycle being every 21-days, so 4 cycles). The dose should be calculated based on body weight at study entry and not recalculated at subsequent dosing."
15819365|NCT04290546|Biological|CIML NK cell Infusion|(Dose 0 or -1) infused on Day 0
15819366|NCT04290546|Drug|Ipilimumab|single dose of lead-in ipilimumab via iv per protocol determined dose
15819367|NCT04290533|Device|Active High Definition transcranial Direct Current Stimulation (HD-tDCS)|TDCS is a non-invasive neuromodulation technique that modulates membrane potentials by means of small electrical currents. Electrical currents induced by tDCS electrodes produce an electrical field that modulates the excitability of brain areas. In the present HD-tDCS montage, one anodal electrode and four return electrodes are applied. Hereby, the anodal electrode modulates the excitability of the targeted area, whereas the other 4 electrodes return electrical currents that flow away from that area. Direct currents will be transmitted through 5 circular PiStim electrodes of 3.14cm2 (Neuroelectrics, Barcelona, Spain; current density=0.32 mA/cm2) with a current intensity of 1.5 mA. The HD-tDCS session will last for 20 minutes in total, with a 60 sec ramp at the beginning and end of the session. The electrodes will be filled with conductive gel and plugged into an EEG cap, with the anode placed over Fz and the four return electrodes over Fp1, Fp2, F7, and F8 (10-20 system).
15819368|NCT04290533|Device|Sham High Definition transcranial Direct Current Stimulation (HD-tDCS)|For the sham-condition, the placement of the electrodes was identical to active HD-tDCS stimulation with the anode placed over Fz and the four return electrodes over Fp1, Fp2, F7, and F8 (10-20 system). The direct current, also transmitted through 5 circular PiStim electrodes of 3.14cm2 (Neuroelectrics, Barcelona, Spain; current density=0.32 mA/cm2), was increased in a ramp-like fashion over 60 seconds until it reached 1.5 mA. Directly after ramp-up, the current intensity was gradually switched off over 60 seconds, followed by 20 minutes without active stimulation. Sham procedures for tDCS mimic the transient skin sensation at the beginning of active HD-tDCS, without producing any conditioning effects on the brain. Consequently, participants are reliably blinded for sham tDCS.
15819369|NCT04290520|Other|bioassay|Serum progesterone level (ng/ml)
15819370|NCT04290494|Drug|IV rtPA (intravenous recombinant plasminogen activator)|intravenous injection
15819371|NCT04290481|Other|oxygen saturation and perfusion index screening|Oxygen saturation and perfusion index values that are measured by pulse oximeter is used for screening critical congenital heart disease.
15819372|NCT04290468|Device|Dynamic ultrasound|"The ultrasound examination will be carried out blinded to the results of MRI using the Affiniti 70 ultrasound machine by Philips (USA) via a 5-12MHz linear transducer.
~MRI was performed on a high field system (1.5 Tesla) magnet units (Philips Acheiva)."
15819373|NCT04290455|Device|Microblepharoexfoliative procedure with BlephEx™|The device will be used to clean both upper and lower eyelid in the office visit.
15819374|NCT04290455|Procedure|Eyelid cleansing with eyelid wipes (Optase)|Eyelid cleansing will be done with eyelid wipes (Optase) by one clinician
15819375|NCT04290455|Procedure|Daily eyelid cleansing with eyelid wipes (Optase)|Patients in both arms will be instructed to do self-eyelid cleansing with eyelid wipes (Optase) daily at home for 21 days
15819376|NCT04290442|Procedure|adductor canal block|The block is performed in supine position under ultrasound guidance using 22 G Touhy needle advanced in plane and 15 cc of 0.5% Ropivacaine ( local anesthetic) with dexmedetomidine 20-30 mcg depending on the age of the patient is injected at midthigh level lateral to the femoral artery in adductor canal to provide sensory blockade to the anterior aspect of the knee.
15819377|NCT04290442|Procedure|SPANK|SPANK: The block is performed in supine position, using 22 G Touhy needle, under ultrasound guidance, needle is advanced in plane to posteromedial shaft of femur taking care to avoid popliteal artery, and 0.5% ropivacaine 15 cc, dexmedetomidine 20-30mcg and dexamethasone 4 mg is injected into inner thigh above the knee provide sensory block to posterior aspect of the knee.
15819378|NCT04290442|Drug|Ropivacaine|ropivacaine 0.5% will be use in the block
15819379|NCT04290429|Drug|Teduglutide|Treatment of patients with SR-GI-GVHD with teduglutide
15819380|NCT04290416|Diagnostic Test|Microwire electrodes|
15819381|NCT04290403|Device|Pull Ups|Participants will be asked to wear pull-ups continence products for the duration of four weeks
15819382|NCT04290403|Device|Styled Briefs with tapes|Participants will be asked to wear styled briefs with tapes for the duration of four weeks
15819383|NCT04290390|Drug|Segesterone Acetate and Ethinyl Estradiol|Contraceptive Vaginal System
15819384|NCT04290390|Drug|Rifampin|CYP3A inducer
15819385|NCT04290390|Drug|Itraconazole|CYP3A inhibitor
15819386|NCT04290377|Device|BMI-assisted motor imagery OT|As the goal of the intervention is to promote finger extension in participants who are unable to extend his/her finger due to stroke, the pneumatic glove provides extension assist when appropriate brain activity is present. The brain activity is obtained by Functional Near-Infrared Spectroscopy (fNIRS). Hypothetically, this will repeatedly induce brain activation that is related to finger extension.
15819387|NCT04290377|Other|Motor imagery OT|In Motor imagery OT, Subjects try to extend their fingers (imagine) without BMI assistance. All other setting is equal to BMI-assisted motor imagery OT.
15819388|NCT04290364|Other|Palliative care|The patients in the prospective part of the study are seen on home-visits and offered standard palliative care within three weeks of diagnosis.
15819389|NCT04290351|Procedure|band ligation|"Rubber band ligation will be applied to patients, and then phlebotonic will be prescribed.
~(Note: The researcher has no contribution or intervention to the treatment method. Patients receiving this treatment will be observed.)"
15819390|NCT04290351|Drug|oral 450 mg diosmin+50 mg hesperidin|"450 mg diosmin + 50 mg hesperidin will be prescribed to patients undergoing band ligation.
~(Note: The researcher has no contribution or intervention to the treatment method. Patients receiving this treatment will be observed.)"
15819391|NCT04290338|Other|PIOMI|Intraoral and extraoral stimulation.
15819392|NCT04290325|Drug|HMPL-453|HMPL-453 tablet
15819393|NCT04290312|Other|Mastiha oil|After overnight fasting, the authorized study staff inserted a plastic cannula in an arm vein of the volunteers in order to minimize discomfort during consecutive blood sampling. A blood sample was collected on time point 0h and then the volunteers consumed 1mL of MO. The dose selection was based on the study of Papada et al. (2017) who administered healthy volunteers with 10g of Mastiha (containing ~10% MO). Afterwards blood samples were collected on time points 0.5h, 1h, 2h, 4h, 6h and 24h after MO intake, and were centrifuged at 3000rpm for 10 minutes at 4◦C for plasma and serum isolation. All samples were stored at -80◦C until further analysis.
15819394|NCT04290299|Other|Data collection|Cancer (response, relapse) and fertility (pregnancy, delivery) outcomes
15819395|NCT04290286|Other|i2TransHealth|i2TransHealth: online intervention for trans persons
15819396|NCT04290273|Diagnostic Test|MED Test|Participant is irradiated with several doses of UV light on small areas of the outer thigh. 24 hours later this area is visually inspected for erythema, and the minimal erythemal dose (MED) is determined.
15819397|NCT04290273|Device|Wearing device|Participants wear a portable erythema measurement device for 48 hours. The device shines light on the skin at frequent intervals and measures skin 'redness'. The device is removed by a technician after the 48 hours.
15819398|NCT04290260|Other|Use of breast bra|Patients will use a breast from admission to hospital discharge
15819399|NCT04290260|Other|Usual care (not use of bra)|
15819400|NCT04290247|Diagnostic Test|Ultrasound|Ultrasound imaging for fracture diagnosis before conventional X-ray
15819401|NCT04290234|Other|fMRI assessment of cognitive and reactive fear|An fMRI paradigm will be used to probe how childhood maltreatment may modulate the defensive survival circuitry that facilitates escape decisions when subjects encounter fast- or slow-attacking threats.
15819402|NCT04290221|Other|Ultrasound-guided percutaneous electrolysis in the lumbar nerve root|This group will be treated with intratissue percutaneous electrolysis using a needle G32 with galvanic current as a cathodic flow electrode in the posterior nerve root of L3 (one times per week / 3 weeks). The intervention will be guided by ultrasound equipment medically certified (Directive 93/42 / EEC) device (EPI Advanced Medicine, Barcelona, Spain).
15819403|NCT04290221|Other|Ultrasound- guided Percutaneous electrolysis in trigger points|It consists in apply the ultrasound-guided percutaneous electrolysis on active and/or latent TPs in the gluteus medius, quadratus lumborum, and erector spinae muscles of the subjects L3 (one times per week / 3 weeks).
15819404|NCT04290208|Drug|Acetaminophen|IV Acetaminophen
15819405|NCT04290208|Drug|Acetaminophen|Acetaminophen liquid syrup
15819406|NCT04290208|Drug|Placebos|Flavored, non-medicated (placebo) liquid syrup
15819407|NCT04290208|Drug|Placebos|IV salt solution (non-medicated)
15819408|NCT04290195|Drug|Ziv-Aflibercept 25 MG/ML [Zaltrap]|Intravitreal injection of 1.25 mg of ziv aflibercept in patients
15819409|NCT04290182|Biological|MSC-KI-PL-204|Autologous MSC product
15819410|NCT04290169|Drug|IncobotulinumtoxinA|IncobotulinumtoxinA will be injected in upper extremities according to recommended guidelines. Two methods will be used in the study: auditive electromyography (EMG) and ultrasound guided injection technique. The decision process of which muscles to inject will be based on information obtained through examination of hand function, the presence of increased muscle tone during the clinical examination as well as a positive response from auditive EMG
15819411|NCT04290169|Device|Video game|"The study will include the Nintendo Switch or similar consoles that include games that require the players to move their bodies while holding motion controllers in order to progress. The games included in this project has been chosen by staff at our hospitals Virtual Gaming Lab. The participants are recommended to train 30 minutes each day, 4 days a week, during the training periods. It is expected that the amount of training will vary among the participants. Thus, each participant will be instructed to keep a training-diary and weekly report number of hours played/trained through an online reporting system created with online form, an electronic data collection system available through the University of Oslo"
15819412|NCT04290156|Other|joint visits|The intervention is the implementation of joint transition visits with the participation of both the pediatric and the adult gastroenterologist. One-year intervention period was chosen. In total, there are four joint visits every third months for the adolescents aged 17-18. Each joint visit lasts for at least for 20 minutes, although in case of complex medical history, there is no restriction with respect to the length of the visit. Joint transition visits 1, 2 and 3 (V1-3) are led by the pediatric gastroenterologist, and visit 4 (V4) is led by the adult gastroenterologist.
15819413|NCT04290143|Other|Colored healing water|Patients will be treated with colored healing water for 20 minutes.
15819414|NCT04290143|Other|Placebo treatment (colored tap water)|Patients will be treated with colored tap water for 20 minutes.
15819415|NCT04290130|Other|Measurement of brain activity using electrodes.|We will present audiovisual speech and record neural responses.
15819416|NCT04290117|Behavioral|Acceptance and Commitment Training|During the ACT-based intervention, participants will get 4 training sessions in groups, once a week for an hour. Additionally, participants will be asked to implement behavioural exercises such as mindfulness and value-based exercises into their daily schedule.
15819417|NCT04290117|Behavioral|Sleep Hygiene and bright light in the morning|During the chronobiological intervention, participants will get 4 training sessions in groups, one hour per week. Additionally, they will use a daylight lamp at home, for 30 minutes per day after waking up.
15819418|NCT04290104|Drug|1gr oral ampicillin/sulbactam group|Group prescribed 1 g oral ampicillin/sulbactam 2 times a day.
15819419|NCT04290078|Device|Kaia Back Pain Study App|Kaia Back Pain is an integrated solution for self-management of low-back pain that digitizes multidisciplinary rehabilitation into a smartphone application.
15819420|NCT04290078|Other|Usual Care|Participants in the control arm will be provided with online links to educational materials about home exercises and pain management and asked to continue their usual care. On-line resources will include links to Web MD, the National Library of Medicine (Medline), and OnHealth
15819439|NCT04289844|Other|Elastic-explosive and resistance strength|"The resistance exercises are: running (3 minutes), 2 farmers carrying marching, 3 side to side ankle hops, 4 plyo lunge jump, 5 lateral jump over barrier, 2 monopodalic jump with ball pass, 3 board throw with half court sprint, 4 lateral shuffle mirror, and 5 combo finisher 4x4.
~Plyometric exercises are: ankle rotations, knee extension, squat, hip flexion-extension, knee and ankle, ankle mobilizations, squat with rise, pelvis ante / retroversion, global mobilization, stride"
15819421|NCT04290065|Other|Manual therapy|The patient will be lying supine, relaxed. The physiotherapist, located at the patient's head, will cover the occipital bone with one hand while the palm of the hand will rest on the lambdoid suture, and the fingers will be introduced into the suboccipital space. The other hand, with a glove, will be inserted into the patient's oral cavity, resting respectively the index and middle fingers, each in an upper dental hemiarchy, on the chewing face of the tooth. An axial traction will be carried out until the three tension barriers of equal size between them are overcome, in an estimated time between 1.50 and 3 minutes. All manual therapy sessions will be performed by the same physiotherapist, following the same protocol and under the same conditions.
15819422|NCT04290039|Drug|Atropine Sulfate Ophthalmic Solution|Atropine sulfate ophthalmic solution, USP 1% is a sterile topical anti-muscarinic indicated for cyclopegia, mydriasis, and penalization of the healthy eye in the treatment of amblyopia. Each mL of Atropine Sulfate Ophthalmic Solution USP, 1% contains active ingredient: atropine sulfate 10 mg equivalent to 8.3 mg of atropine. Inactive ingredients include benzalkonium chloride 0.1 mg (0.01%), dibasic sodium phosphate, edetate disodium, hypromellose (2910), monobasic sodium phosphate, hydrochloric acid and/or sodium hydroxide may be added to adjust pH (3.5 to 6.0), and water for injection, USP.
15819423|NCT04290039|Drug|Atropine Sulphate Injection|Atropine sulfate injection, USP, 8mg/20mL (0.4 mg per mL) is a sterile, nonpyrogenic, isotonic, clear solution of atropine sulfate in water for injection with sodium chloride sufficient to render the solution isotonic. Each mL contains atropine sulfate, 0.4 mg; benzyl alcohol, 9 mg; sodium chloride 9 mg; and may contain sulfuric acid for pH adjustment, pH 3.5 (3.0 to 3.8).
15819424|NCT04290026|Drug|metoclopramide versus granisetron|ِِِِAssessment of the effect of metoclopramide versus granisetron on gastric volume in patients undergoing caesarean section by us
15819425|NCT04290013|Drug|norethisterone acetate|norethisterone acetate 15 mg daily from day 5 of the cycle to day 26.
15819426|NCT04290013|Drug|tranexamic acid tablets|tranexemic acid 1 gm three times daily from the first day of the menstrual cycle up to 5 days .The dose can be increased but not exceeding 4 gm per day.
15819427|NCT04290000|Other|additional biological samples during CAR-T CELL treatment|"Blood samples (additional tubes) and marrow (quantity taken in addition from the same aspiration) will be collected in addition to those useful for the follow up of the patients (progress of their disease after treatment with CAR-T Cells) at specific points in his treatment journey.
~The following samples will also be collected during Apheresis and at Car-T Cells reinjection :
~Apheresis sampling
~CAR-T Cells collected from bag rinsate
~In case of invasion, a skin biopsy will be made, 2 days and 8 days after the beginning of the CAR T Cell Treatment, during the patient's hospitalization and during a consultation visit in case of therapeutic progression or failure."
15819428|NCT04289987|Biological|CVI-HBV-002, Normal Saline|Investigational Product
15819429|NCT04289974|Drug|Palbociclib|Palbociclib (125 mg PO qDay for Days 1-21 of each 28-day cycle) combined with Fulvestrant (500 mg IM on Days 1, 15, and 29, and then once monthly thereafter)
15819430|NCT04289961|Diagnostic Test|Portal vein sampling|During Endoscopic UltraSound guided-Fine Needle Aspitation (EUS-FNA) a curvilinear echoendoscope is advanced to the distal stomach or duodenal bulb to provide a window of access to a branch of the PV. After verifying venous flow by Doppler signal, a 19-gauge EUS-FNA needle is advanced transhepatically into the portal vein branch. With the needle in the portal vein, the stylet is removed and negative-pressure suction is applied to aspirate blood. A transhepatic approach for portal vein branch access is an absolute requirement of this technique in order to minimize the risk of bleeding. The puncture site is monitored under EUS for complications.
15819431|NCT04289948|Drug|Phage|The studies will be undertaken using a cocktail of at least 2-3 anti-staphylococcal phages produced by Intralytix Inc, Baltimore, Maryland, USA. The phages will be included in a gel designed for application directly to the wound surface and packaged in 5 ml single use tubes.
15819432|NCT04289935|Procedure|Vacuum assisted biopsy (VAB)|The trial intervention consists of a diagnostic interventional procedure, US-guided or mammographically guided VAB post-NAC, prior to the standard breast surgery.
15819433|NCT04289909|Other|Adaptive Optics Ophthalmoscopy (AOO)|AOO will permit to detect and quantify retinal perivascular inflammation in patients with MS in comparison to Healthy volunteers (control group)
15819434|NCT04289896|Other|Plyometric exercise|"The plyometric program to be followed by the subjects assigned to the experimental group during the four weeks includes: Squat jumps, alternate lunge, cyclic horizontal jump, horizontal left leg jump, horizontal right leg jump, vertical left leg jump, right leg vertical jump, squat box jumps, box jumps left leg, box jumps right leg, box to box squat jumps, box to box left leg, box to box right leg.
~In all the exercises the subjects will be able to help themselves with the arms and a rest period of 120 seconds will be left between each series.
~The intervention will be carried out prior to training, keeping a minimum of 48 hours of rest between sessions."
15819435|NCT04289883|Combination Product|Nano-particulated whey protein vs non-particulated whey protein (control)|Different particularisations of whey protein were identified to potentially delay digestion based on in vitro studies and to potentially affect appetite and body weight based on animal studies compared to non-particulated whey protein, with nano-particulated whey protein suggested to be more efficient than micro-particulated.
15819436|NCT04289883|Combination Product|High molecular weight whey protein-alginate coacervates vs calcium alginate (control)|Different whey protein-alginate coacervates were identified to potentially delay digestion based on in vitro studies and to potentially affect appetite based on animal studies compared to calcium alginate, with high molecular weight alginate suggested to be more efficient than low molecular weight alginate.
15819437|NCT04289870|Device|Trillium™|Trillium™ Stent Graft for Functional Tricuspid Valve Replacement
15819438|NCT04289857|Other|Neurodynamic training|Starting from a sitting position on a stretcher, with dorsolumbar flexion, it is required to maintain that posture throughout the exercise. Sliding with the straight leg sitting consists of performing alternate movements. First, knee extension and dorsal ankle flexion will be performed, increasing neural tension, combined with cervical extension (to decrease neural tension) in the first instance. Subsequently, knee flexion and plantar ankle flexion (decreasing neural tension) combined with cervical flexion (increasing neural tension) will be performed. The dosage of the technique will be: two seconds for each movement, with 10 repetitions of each one. All sessions will be led by one of the group's researchers.
15819505|NCT04289337|Dietary Supplement|Combined heat-killed probiotics (1)|Subjects used one oral combined heat-killed probiotics (1) tablet each morning, noon, and evening for 4 weeks.
15819440|NCT04289844|Other|Elastic-explosive strength|Plyometric exercises are: ankle rotations, knee extension, squat, hip flexion-extension, knee and ankle, ankle mobilizations, squat with rise, pelvis ante / retroversion, global mobilization, stride
15819441|NCT04289831|Procedure|Preoperative Biliary Drainage (PBD)|Endoscopic retrograde biliary drainage (ERBD) and stent placement was the first choice for PBD while ultrasound-guided percutaneous transhepatic biliary drainage (PTBD) was done if ERBD was not feasible. Biliary drainage was considered successful if the serum bilirubin level decreased by 50% or more within 2 weeks after the procedure. Patients with failed PBD were referred directly to surgery, while those with successful PBD were referred to surgery 4 to 6 weeks after first drainage procedure according to the latest guidelines
15819442|NCT04289831|Procedure|Surgery|The standard surgical procedure for operable tumors Whipple procedure with triple reconstruction, namely pancreatogastrostomy or pancreatojejunostomy,hepaticojejunostomy and gastrojejunostomy
15819443|NCT04289818|Other|Health Coaching|Health Coaching as face to face with a coach
15819444|NCT04289805|Drug|Letrozole|"Patients start ovarian stimulation protocol according to their menstrual cycle phase at enrollment (standard or random start). Ovarian stimulation includes gonadotropins administration in a GnRH antagonist protocol.
~Standard Protocol: letrozole is orally administered (5mg/d) from cycle day 2-3 throughout the ovarian stimulation with gonadotropins protocol until ovulation triggering.
~Random start protocol: letrozole is administered throughout the stimulation together with gonadotropins.
~GnRH antagonist is administered at cycle day 7 or as soon as at least one follicle reaches 12-14 mm.
~Oocytes are collected 36h after ovulation triggering with GnRH agonist."
15819445|NCT04289805|Other|standard-stimulated cohort|"Patients start ovarian stimulation protocol according to their menstrual cycle phase at enrollment (standard or random start). Ovarian stimulation includes gonadotropins administration in a GnRH antagonist protocol.
~Standard Protocol: Gonadotrophins started from cycle day 2-3 throughout the ovarian stimulation until ovulation triggering.
~Random start protocol: Gonadotrophins started at any time of the cycle and throughout the stimulation.
~GnRH antagonist is administered at cycle day 7 or as soon as at least one follicle reaches 12-14 mm.
~Oocytes are collected 36h after ovulation triggering with GnRH agonist."
15819446|NCT04289792|Drug|nab-Paclitaxel+Gemcitabine|Drug: nab-Paclitaxel 125 mg/m2 IV over approximately 30-45 min on Days 1 and 15, followed by gemcitabine 1000 mg/m2 IV infusion over approximately 30 min on Days 1 and 15 of each 28-day cycle for 6 cycles.
15819447|NCT04289792|Radiation|split-course SBRT|Radiation: During the first 1 and 2 cycles of chemotherapy, SBRT was given as a single irradiation of 10 Gy ⅹ 4 times (Days 2 and 16 of each 28-day cycle).
15819451|NCT04289766|Other|Conventional Treatment|These individuals will receive the conventional intervention including the routine rehabilitation therapy like active and passive ROMs, stretching, strengthening of upper limb, balance improvement exercises. Time duration is of 40 minute 3 times per week.
15819452|NCT04289766|Other|Focal Muscle Vibration (120Hz)|These individuals will receive conventional therapy along with Focal Muscle Vibration applied to the hyper toned muscles (Bicep Brachialis and Extensor Carpi Radialis). Evaluation at baseline and after the end session (Total 24 session). i.e. 3 sessions/week for 8 weeks.
15819453|NCT04289766|Other|Focal Muscle Vibration (60Hz)|These individuals will receive conventional therapy along with Focal Muscle Vibration applied to the hyper toned muscles (Bicep Brachialis and Extensor Carpi Radialis). Evaluation at baseline and after the end session (Total 24 session). i.e. 3 sessions/week for 8 weeks.
15819454|NCT04289753|Behavioral|EHR clinical decision support nudges|Clinical decision support nudges delivered within the EHR when conditions meet alert triggering criteria.
15819455|NCT04289753|Behavioral|Brief clinician education|Clinicians will be invited to view brief education material.
15819456|NCT04289740|Behavioral|7 sessions (1.5 hr/session) in groups of approximately 8-10 individuals|Patients assigned to the experimental group will receive 7 sessions (1.5 hr/session) in groups of approximately 8-10 individuals over a 12 week period
15819457|NCT04289740|Behavioral|a progressive muscle relaxation group intervention, based on the Bernstein and Borkoveck procedure plus same number of sessions as the experimental intervention.|The control group will receive a progressive muscle relaxation group intervention, based on the Bernstein and Borkoveck procedure. This intervention will have the same number of sessions as the experimental intervention and last anywhere from 60 to 90 minutes, depending on the session.
15819458|NCT04289714|Device|Novel Electronic Monitoring Device|Four Novel electronic Monitoring Devices were trialled
15819459|NCT04289701|Other|Health Services for Systematic Hypertension Management|"The systematic hypertension management health services from the Hypertension prevention and control initiative in China project. Main services are as follows:
~Healthcare provider training and patient education.
~Standardized guideline-based hypertension diagnosis, treatment and management recommendation.
~Patient-centered, pan-cycle continuous hypertension management via the organizing framework of NMAH and sharing digital platform.
~Periodical Patient follow-up via blood pressure monitor-sharing system and in collaboration with other basic local public health programs.
~Outcome and performance evaluation quarterly.
~Incentives for healthcare organizations and primary healthcare providers, and subsidies to patients.
~Certification for Honorary Hypertension Centers at county levels and establishment for hypertension clinics at primary care centers."
15819460|NCT04289675|Drug|Interferon-Beta|Theses drugs have been administered as part of routine care. Biological samples that will be analyzed (blood and cerebrospinal fluid) have been taken as part of routine care.
15819461|NCT04289662|Drug|K-924 LD|Pitavastatin 2 mg / Ezetimibe 10 mg tables
15819462|NCT04289662|Drug|K-924 HD|Pitavastatin 4 mg / Ezetimibe 10 mg tables
15819463|NCT04289649|Drug|K-924 LD|Pitavastatin 2 mg / Ezetimibe 10 mg tables
15819464|NCT04289649|Drug|K-924 HD|Pitavastatin 4 mg / Ezetimibe 10 mg tables
15819465|NCT04289649|Drug|K-924 LD Placebo|Pitavastain 2 mg
15819466|NCT04289649|Drug|K-924 HD Placebo|Pitavastain 4 mg
15819565|NCT04288817|Biological|Tuberculin purified protein derivative|Intralesional injection of tuberculin PPD in treatment of multiple common warts
15819467|NCT04289636|Behavioral|Behavioral weight loss program|Using a combination of individual (~1x/month) and group-based (~3x/month) meetings, participants will be taught behavioral approaches for changing diet and exercise behaviors. This intervention will be 15 weeks in duration and will be delivered remotely using a video-conferencing platform.
15819468|NCT04289636|Behavioral|Self-compassion|This 8-week, group-based program will help train individuals on how to handle difficult emotions with greater ease, how to transform difficult relationships, and how to motivate and encourage oneself, rather than being self-critical.
15819469|NCT04289636|Behavioral|Nutrition and cooking education|This 8-week, group-based program will help individuals to improve the quality of their diet through nutrition education and basic cooking skills for preparing healthy meals.
15819470|NCT04289623|Behavioral|Email|Email
15819471|NCT04289623|Behavioral|Loss frame|Email
15819472|NCT04289623|Behavioral|Testimonial (medical expert)|Email
15819473|NCT04289623|Behavioral|Testimonial (rank-and-file)|Email
15819474|NCT04289623|Behavioral|Social norms (percentage)|Email
15819475|NCT04289623|Behavioral|Social norms (number)|Email
15819476|NCT04289610|Device|Transcutaneous pulse radiofrequency therapy|Transcutaneous pulse radiofrequency therapy (TCPRF) is a painless and outpatient physiotherapy modality
15819477|NCT04289597|Diagnostic Test|Distance between hyoid bone-skin (DSHB)|Distance between hyoid bone-skin
15819478|NCT04289597|Diagnostic Test|Vocal cord anterior commissura-skin distance (DSAC)|Vocal cord anterior commissura-skin distance
15819479|NCT04289597|Diagnostic Test|minimum distance of the trachea to the skin at the level of suprasternal notch|Distance of the trachea to the skin at the level of suprasternal notch
15819480|NCT04289597|Diagnostic Test|Thyroid isthmus-skin distance (DSI)|Thyroid isthmus-skin distance
15819481|NCT04289597|Diagnostic Test|Skin-epiglottic distance (DSE)|Skin-epiglottic distance
15819482|NCT04289584|Other|Strength and proprioception exercises|Strength and proprioception exercises will be performed with the athlete in different positions depending on the exercise. There will be 3 series with 30 repetitions and 10-second breaks between sets. Each exercise session will be held for 15 minutes. Theraband® exercises are: unipodal balancing on hard surface with open and closed eyes, unipodal balancing on soft surface, squats, lateral walk, isometric contractions with garter and dynamic leg opening, tiptoe, and eccentric hamstring curl with garter.
15819484|NCT04289558|Drug|Sodium Nitrite|Single 60 minute infusion at 1 of 4 sequential dose levels (0.16, 0.32, 0.64 and 1.28 mcg/kg/minute). The dose amount will depend on when the participant enters the study
15819485|NCT04289545|Dietary Supplement|Functional bread|Postprandial effects of bread containing galactomannan
15819486|NCT04289532|Drug|99mTc-RWY|99mTc-RWY were injected into volunteers and patients before the SPECT/CT scans .
15819487|NCT04289506|Diagnostic Test|mRNA expression|The primary objective is the external validation of our filed patent-claims panels of mRNA biomarkers, which in the inflammatory and SIRS/Sepsis panels have better discriminatory properties than any other published biomarker panel for detecting individuals with severe inflammation and differentiating infectious and non-infectious origin of organ failure (Sepsis/SIRS).
15819488|NCT04289493|Other|Language and functional communication therapy|17 therapy sessions in which the patients will be asked to dubb words or sentences from television series previously considered functionally meaningful for them.
15819489|NCT04289480|Device|ENTERPRISE 2 device|The ENTERPRISE 2 Vascular Reconstruction Device is intended for use with occlusive devices in the treatment of intracranial aneurysms.
15819490|NCT04289467|Drug|Fenfluramine|Open-label
15819491|NCT04289454|Other|Flavor additive|Various flavor additives will be tested (vs. no added flavor) to determine which show promise for making KE drinks taste less unpleasant
15819492|NCT04289441|Dietary Supplement|Bifiasthm|Subjects will be instructed to take an active or placebo sachet twice daily for eight weeks, and subsequent intake of one dose daily for a further eight weeks.
15819493|NCT04289441|Dietary Supplement|Placebo|Placebo
15819494|NCT04289428|Diagnostic Test|Xpert® HBV DNA fingerstick point of care assay|Xpert® HBV DNA point of care assay from finger-stick whole blood
15819495|NCT04289428|Diagnostic Test|Point of Care ALT|Point of Care ALT from finger-stick whole blood
15819496|NCT04289428|Diagnostic Test|Xpert® HBV DNA point of care assay from dried blood spot|Xpert® HBV DNA point of care assay from dried blood spot
15819497|NCT04289415|Behavioral|Individual Placement and Support|Employment specialist will work together with the participants in accordance to the method IPS in order to help the participant obtain competitive employment
15819498|NCT04289402|Other|Personalized tDCS|The participant will receive 10, 20-minutes sessions of personalized tDCS Monday-Friday, at approximately the same time of day, over two consecutive weeks.
15819499|NCT04289402|Other|Active-Sham|The participant will receive 20, 20-minute sessions of active-sham stimulation Monday-Friday, at approximately the same time of day, over two consecutive weeks.
15819500|NCT04289376|Other|Gaze tracking - no intervention|Monitor gaze as subjects watch a video
15819501|NCT04289363|Behavioral|Clinical program implementation|Using mixed methods and triangulating multiple sources of data collected over the course of parent and ancillary studies to evaluate the feasibility, acceptability, sustainability, and impact of the ED-initiated BUP clinical program and implementation facilitation strategy and identify factors influencing diffusion and effectiveness. Converging provider and patient perspectives and field notes with process measures and intervention outcomes, including proportions screened, treated, and engaged in treatment, will provide explanation to contextualize and better understand feasibility, acceptability, and factors associated with the rate with which the ED-initiated BUP innovation is adopted and how well it is sustained.
15819502|NCT04289350|Diagnostic Test|fetal heart rate variability|An observational study. No intervention
15819503|NCT04289337|Dietary Supplement|Combined probiotics (1)|Subjects used one oral combined probiotics (1) tablet each morning, noon, and evening for 4 weeks.
15819504|NCT04289337|Dietary Supplement|Combined probiotics (2)|Subjects used one oral combined probiotics (2) tablet each morning, noon, and evening for 4 weeks.
15819506|NCT04289337|Dietary Supplement|Combined heat-killed probiotics (2)|Subjects used one oral combined heat-killed probiotics (2) tablet each morning, noon, and evening for 4 weeks.
15819507|NCT04289337|Dietary Supplement|Probiotic metabolites|Subjects used one oral probiotic metabolites tablet each morning, noon, and evening for 4 weeks.
15819508|NCT04289337|Dietary Supplement|Placebo|Subjects used one oral placebo tablet each morning, noon, and evening for 4 weeks.
15819509|NCT04289324|Procedure|regular lung recruitment|stepwise oxygenation-guided lung recruitment at regular (twelve hours) intervals during high frequency oscillation ventilation
15819510|NCT04289311|Behavioral|Voice Crisis Alert V2|An mHealth intervention (app) with multiple components for self-management behavior development. Components include: electronic educational information, symptom monitoring and tracking, communication with a provider, health history entry and storage (including medication adherence).
15819513|NCT04289285|Drug|IBI306 450mg SC Q4W|Subjects will receive IBI306 450mg every 4 weeks subcutaneously.
15819514|NCT04289285|Drug|Placebo SC Q4W|Subjects will receive placebo every 4 weeks subcutaneously.
15819515|NCT04289285|Drug|IBI306 600mg SC Q6W|Subjects will receive IBI306 600mg every 6 weeks subcutaneously.
15819516|NCT04289285|Other|Placebo SC Q6W|Subjects will receive placebo every 6 weeks subcutaneously.
15819517|NCT04289285|Drug|IBI306 600mg SC Q6W|Subjects will receive IBI306 600mg every 8 weeks subcutaneously.
15819518|NCT04289285|Other|Placebo SC Q8W|Subjects will receive placebo every 8 weeks subcutaneously.
15819519|NCT04289272|Behavioral|Dove Confident Me|Dove Confident Me is a school-based intervention co-created by researchers at La Trobe University (Australia), the Centre for Appearance Research UWE, teachers, students, and education experts, and the Dove Self-Esteem Project (the social mission for personal care brand Dove). The five-session intervention is aimed at adolescents aged between 11-13 years, and targets recognised risk factors for body dissatisfaction, by addressing societal appearance ideals (Session 1), media literacy (Session 2), appearance comparisons (Session 3), appearance-related conversations and teasing (Session 4), and promoting 'body activism' (Session 5). The intervention consists of classroom-based discussion and small group activities, and uses audio-visual materials and worksheets to facilitate learning.
15819520|NCT04289259|Other|TMB assessment|Tumor mutational burden could be calculated by cancer gene panel (CGP), whole-exome sequencing (WES), RNA-sequencing (RNA-seq), FoundationOne CDx assay panel (FMI).
15819521|NCT04289246|Device|Medication Ambient Display (MAD)|"MAD was implemented for Android tablets to provide the following external cues:
~Abstract and stylized representations of medication adherence. The MAD shows a virtual birdcage, which has the aim of raising elders' consciousness about how they have to take responsibility for caring for their health, in a way similar to willingly caring for a pet. Each day, a newborn pet grows to represent medication compliance. By touching any point on the parakeet's virtual cage, the MAD presents information on the participants' daily medication compliance.
~Auditory and visual reminders. The parakeet provides auditory reminders (a parakeet whistle) and pictograms to inform the medication to take.
~After participants take their medication, they move the MAD closer to the pill container to indicate that the medication was taken. This functionality was implemented through Near Field Communication (NFC) technology. Afterward, the parakeet acknowledges that the medication was registered as taken."
15819522|NCT04289220|Biological|Anti-CD19 CAR-T Cells Injection|Dosage form：injection Dosage:1-2.5x10^6 cells/kg, 100ml/time, The CAR-T cells will be administered by i.v. injection over 20-30 minutes, Frequency: total one time
15819523|NCT04289207|Drug|Romiplostim and danazol|Treatment with romiplostim and danazol
15819524|NCT04289194|Drug|HCR040 (Phase 1)|(Phase 1) Intravenous administration. Open label dose escalation, 3 patients in cohort 1 (1 million cells/kg) and 3 patients in cohort 2 (2 million cells/kg)
15819525|NCT04289194|Drug|Placebo (Phase 2)|(Phase 2) Intravenous administration of vehicle solution
15819526|NCT04289194|Drug|HCR040 (Phase 2)|(Phase 2) Intravenous administration of the maximum tolerated dose (1 million cells/kg or 2 million cells/kg)
15819527|NCT04289181|Other|Medically Tailored Meals|4 weeks of medically tailored meals
15819528|NCT04289168|Behavioral|Music|Music class was provided for the intervention group
15819529|NCT04289155|Drug|GX-I7|patients will receive the assigned dose of GX-I7 intramuscular injection every 4~12 weeks
15819530|NCT04289142|Drug|Dexmedetomidine Hydrochloride Group|Dexmedetomidine will be initiated prior to transfer to the CVICU with loading dose of 1.2 ug kg-1 over approximately 20 minutes. This will be followed by an infusion at 0.1-1.2 ug kg-1h-1 in CVICU for up to 24 hours from the time DEX infusion started or until the patient is ready for discharge from the CVICU (whichever is earlier).
15819531|NCT04289129|Diagnostic Test|Myotonometric evaluation|Vertically placed on the muscle, a probe (3 mm diameter) creates constant pre-excitations (0.18 N) and generates short-term (15 ms), low-force (0.4 N) mechanical stimulations.
15819532|NCT04289116|Behavioral|We Test|This design tests the added benefits of adjunct intervention components delivered prior to receipt of CHTC-Assertive Communication Training (ACT) videos viewed by the couple separately and individually delivered Motivational Interviewing-based Communication Skills Training (MI-CST). These target the development of communication skills necessary to participate fully in HIV prevention and sexual safety discussions inherent to CHTC.
15819533|NCT04289116|Behavioral|IHTC|Individual HIV Testing and Counseling
15819534|NCT04289103|Biological|Inolimomab (Leukotac)|"Patient screening phase - Patients diagnosed with aGvHD will be identified. Only patients with SR-aGvHD will be finally included in the study.
~Treatment phase - Leukotac will be given up to D28
~Primary Follow-up phase - Patient's response (CR and PR) will be evaluated at D29 post inclusion. Patients will then be followed for survival, long-term safety and chronic GvHD occurrence during 6 months after inclusion."
15819593|NCT04288570|Procedure|suture anchor socket creation with punch|suture anchor socket creation with punch
15819535|NCT04289090|Drug|Sevoflurane Inhalant Product|This study will perform intra-operative sonographic ONSD measurements in order to compare the change in ONSD during transition from inhalational maintenance anesthesia (using sevoflurane) to total intravenous anesthesia (TIVA) using propofol.
15819536|NCT04289090|Drug|Propofol 10 MG/ML|This study will perform intra-operative sonographic ONSD measurements in order to compare the change in ONSD during transition from inhalational maintenance anesthesia (using sevoflurane) to total intravenous anesthesia (TIVA) using propofol.
15819537|NCT04289077|Other|Questionnaires|- Baseline questionnaire, version 1.0, October 29 2019, (Dutch) - Health care utilization, version 1.0, October 29 2019, (Dutch) - Decision-making, version 1.0, October 29 2019, (Dutch) - EORTC QLQ-C30, version 3.0, (Dutch) - DTF-QoL, version 1.0, October
15819538|NCT04289064|Device|Taking a fundus image|The participant only needs to take a fundus image as usual.
15819539|NCT04289051|Device|HYDRAL Oral Rinse|Application 4 times a day for two weeks
15819540|NCT04289051|Device|BIOTENE® Oral Rinse|Application 4 times a day for two weeks
15819541|NCT04289051|Device|Placebo Oral Rinse|Application 4 times a day for two weeks
15819542|NCT04289038|Other|prucare program|training, counseling and autogenic relaxation and virtual reality game application
15819543|NCT04289025|Other|Exercise|A set of exercises are provided to each patient.
15819544|NCT04289012|Diagnostic Test|Helicobacter Pylori screening by UBT|The UBT is based on the fact that Hp produces urease, which catalyzes the urea molecule into ammonia (NH3) and carbon dioxide (CO2). After fasting for six hours prior to testing, the patient swallows a C13 Urea tablet or solution and waits. After 10 minutes, the patient exhales and breath is collected (tube, bag or breath card). The production of 13CO2 is measured by a desktop analyzer (infrared mass spectrometry) and Hp diagnosis is made based on previously established cut-off levels for Hp infection.
15819545|NCT04288999|Drug|Chemotherapy|"Adjuvant chemotherapy: CAPOX or mFOLFOX6 or capecitabine or 5-FU+l-LV
~CAPOX: oxaliplatin (130 mg/m2/day, day 1) and oral capecitabine (2000 mg/m2/day, twice daily, days 1-14)
~mFOLOX6: oxaliplatin 85 mg/m2 with l-LV 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion over 46 hours.
~Capecitabine: 2000 mg/m2/day, twice daily, days 1-14
~5-FU+l-LV: leucovorin 200 mg/m2 for over 2 hours followed by a fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion for over 46 hours"
15819546|NCT04288999|Radiation|Preoperative radiotherapy|"Preoperative chemoradiotherapy (CRT) followed by Surgery plus Adjuvant chemotherapy
~Preoperative CRT: capecitabine (1650 mg/m2/day) and radiotherapy (50.4 Gy/28 Fr)"
15819547|NCT04288999|Other|Procedure|"Surgery for Locally Recurrent Rectal Cancer (LRRC) will be performed within 42 days from registration for the patients in arm A, and between days 56 and 98 from the completion of the preCRT for the patients in arm B.
~Appropriate surgical procedure will be performed to achieve R0 resection, such as low anterior resection, super low anterior resection, intersphincteric resection, Hartmann procedure, rectal amputation, pelvic exenteration, tumor resection, or lateral lymph node dissection"
15819548|NCT04288986|Behavioral|Keep Achieving|The 8-week group based activity programme will consist of 8 sessions each lasting 50 minutes.
15819549|NCT04288973|Diagnostic Test|Microsoft Kinect Detection during mother child interaction|methodology based on RGB-D sensors applied to the setting of free parent-infant interaction
15819550|NCT04288960|Device|Gwalk accelerometer walking trials|No intervention. Participants will wear a belt mounted accelerometer and complete walking trials to assess validity of the device
15819551|NCT04288947|Other|Disrespect and Abuse in Maternity Care|Changing the culture of disrespect and abuse in maternity care
15819552|NCT04288934|Biological|Collection and expansion of BM-MSC|MSCs collection from patients owns marrow using a volume of 20 ml of bone marrow obtained from iliac crest of SCI patients under local anesthesia. Manipulations of blood and bone marrow are to be done according to Good Laboratory Practice (GLP) using the gradient sedimentation method.
15819553|NCT04288934|Diagnostic Test|VI-SCI evaluation and patients' follow up|"At 6, and 12 months post MSCs transplantation, patients' spine will be imaged using 3 Tesla MRI and compared to baseline.
~The (ASIA)/(ISNCSCI) score will be repeated every 3 months to evaluate any motor or neurological changes
~The Spinal Cord Independence Measure (SCIM III) score will be repeated every 3 months to evaluate the effect on daily activities.
~Blood samples will be withdrawn from patients at 3 months interval for biomarkers detection."
15819554|NCT04288921|Diagnostic Test|Swab|Swab samples for diagnostic test
15819555|NCT04288908|Other|Cyberball experimental task|Cyberball is an experimental task in which participants have to pass a ball to two virtual players during 60 passes in total
15819556|NCT04288895|Drug|Vortioxetine|5 - 20 mg/day flexible-dose vortioxetine, tablets, orally
15819557|NCT04288882|Device|Enteroscopy|Role of Balloon-Assisted Enteroscopy (BAE) in management of Small Intestinal Disorders
15819558|NCT04288869|Other|Continuous monitoring of arterial blood pressure|For all patients, mean arterial pressure (unit mmHg) will be collected over three distinct periods: 1) baseline or during pre-oxygenation at FiO2 of 21% in awake patients, 2) before orotracheal intubation, and 3) just after mechanical ventilation.
15819559|NCT04288869|Other|Transcranial Doppler|"Measurement of cerebral blood flow velocity (CFV) with use of Transcranial Doppler ultrasonography.
~For all patients, CFV (unit cm/s) will be collected over three distinct periods: 1) baseline or during pre-oxygenation at FiO2 of 21% in awake patients, 2) before orotracheal intubation, and 3) just after mechanical ventilation."
15819560|NCT04288869|Other|Bispectral Index (BIS)|"Continuous measurement of burst suppression (BS; %) with use of Bispectral Index (BIS).
~For all patients, BS will be collected over three distinct periods: 1) baseline or during pre-oxygenation at FiO2 of 21% in awake patients, 2) before orotracheal intubation, and 3) just after mechanical ventilation"
15819561|NCT04288869|Other|Near-infrared spectroscopy|"Continuous measurement of cerebral oxygen saturation (SO2) with Near-infrared spectroscopy (NIRS).
~For all patients, SO2 (%) will be collected over three distinct periods: 1) baseline or during pre-oxygenation at FiO2 of 21% in awake patients, 2) before orotracheal intubation, and 3) just after mechanical ventilation."
15819562|NCT04288856|Drug|BIIB078|Administered as specified in the treatment arm.
15819563|NCT04288830|Behavioral|Tai Chi Moving Mindfulness Meditation and Resilience Training|Low-impact mind-body exercise adapted from traditional tai chi.
15819564|NCT04288830|Behavioral|Aerobic Exercise|Low-impact aerobic exercise, led by instructor
15820145|NCT04283656|Drug|Estradiol 2mg|4mg orally for two doses, twice-daily
15819566|NCT04288804|Device|Smartphone microphone sensor|The volunteer will record themselves sustaining the short a vowel sound for 10 seconds.
15819567|NCT04288804|Device|Smartphone accelerometer sensor|The volunteer's smartphone's accelerometer will record accelerometer data (positions on the x, y, and z axes) while the volunteer maintains 4 positions, each for 10 seconds.
15819568|NCT04288791|Other|Equia Forte Fil|Glass hybrid innovation achieved through the introduction of ultrafine, highly reactive glass particles dispersed with conventional GI. The restoration is coated with Equia Forte coat which incorporates multi-functional monomer producing a tougher resin matrix. This system is designed as alternative of amalgam in posterior teeth.
15819569|NCT04288791|Other|Zirconomer Improved|Zirconia reinforced GI, Glass Polyalkenoate restoration; it is designed to exhibit high strength where the glass component of this GI undergoes finely controlled micronization to achieve optimum particle size and characteristics .
15819571|NCT04288765|Drug|Daratumumab Only Product in Parenteral Dose Form|"Induction = 8 cycles Carfilzomib on Day 1st, 8th and 15th Lenalidomide: Day 1 to 21
~Daratumumab:
~Cycles 1-2: weekly Cycles 3-4: every two weeks Cycles 5-8: every month Dexamethasone: 40 mg weekly"
15819572|NCT04288752|Device|VR101 Lubricating Intravaginal Ring|VR101 Lubricating Intravaginal Ring is a personal lubrication device, for vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication.
15819573|NCT04288752|Device|Sham Ring|Sham rings are visually identical to VR101 Lubricating Intravaginal Rings, but no lubricating solution was added.
15819574|NCT04288739|Diagnostic Test|flow cytometric immunophenotyping|Flow cytometric (FCM) immunophenotypic analysis of peripheral blood or bone marrow aspiration samples will be performed using a panel of monoclonal antibodies (HLA DR, CD34, CD117, Cyto MPO, CD13, CD33, CD3, CD4, CD8, CD10, CD19, CD5, CD14, CD64, CD36, CD235a, cyto CD41, cyto CD61).
15819575|NCT04288739|Genetic|Xist gene by fluorescence insitu hybridization|"Fluorescence in situ hybridization (FISH) is a kind of cytogenetic technique that allows the visualization of defined nucleic acid sequences in particular cellular or chromosomal sites by hybridization of complementary fluorescently labeled probe sequences within intact metaphase or interphase cells.
~The fluorescent probes are nucleic acid labeled with fluorescent groups and can bind to specific DNA/RNA sequences. Fluorescence microscopy can be used to find out where the fluorescent probe is bound to the chromosomes."
15819576|NCT04288726|Biological|CD30.CAR-EBVST cells|"The dose is based on the number of CD30.CAR-expressing cells. In our previous study the highest dose was 2 × 108 cells/m2 and we did not reach a MTD.
~There will be a gap of 4 weeks between the first and second patient on each dose level.
~On Day 0 of study, patients will receive their planned single dose of investigational T cell product by IV infusion over approximately 1 to 10 minutes in an expected volume of 1 to 50 mL."
15819577|NCT04288713|Drug|Eculizumab|A distal complement inhibitor.
15819578|NCT04288700|Drug|oral propranolol|oral propranolol therapy at a dose of 1 mg/kg/d (Inderal 20 mg/5 mL) in three divided doses. If the child will tolerate the treatment with no side effects, therapy will continue in an outpatient clinic. Blood glucose level will be also measured in a periodic manner during therapy. The dose will be increased gradually to 2 mg/kg/d in three divided doses if there will be no adverse effects from the initial therapy.
15819579|NCT04288700|Drug|Oral Captopril|A test dose of 0.1 mg kg) will be administered orally with pulse rate and blood pressure monitored at 0.5, 1 and 2 h and at each follow up. If the test dose is tolerated, captopril administration will start at 0.15 mg kg) per dose 8-hourly. Pulse rate and blood pressure will be monitored 4-hourly and doses will be withheld if hypotension is documented. After 24 h, the dose will be increased to 0.3 mg kg) per dose 8-hourly .
15819580|NCT04288700|Drug|intralesional propranolol injection|intralesional propranolol injection 1 mg/mL
15819581|NCT04288700|Drug|topical Timolol maleate 0.5% eye drops|To be Applied on the surface of the lesions three times daily
15819582|NCT04288687|Drug|Niraparib Pill|Niraparib 200 mg by mouth daily (2 x 100 mg pills)
15819583|NCT04288674|Other|Retrospective data collection of demographics|Retrospective data collection of demographics from patients with leptospirosis and matching control group patients.
15819584|NCT04288674|Other|Retrospective data collection of underlying diseases|Retrospective data collection of underlying diseases from patients with leptospirosis and matching control group patients.
15819585|NCT04288674|Other|Retrospective data collection of duration of hospitalization|Retrospective data collection of duration of hospitalization from patients with leptospirosis and matching control group patients.
15819586|NCT04288661|Procedure|No drain placement|The need of perianastomotic drain placement after Roux-en-Y reconstruction in total gastrectomy operations is investigated. As intervention, no drain placement is considered
15819587|NCT04288648|Diagnostic Test|ultrasound examination|ultrasound examination of pelvic floor muscle will be conducted. In addition questionnaires regarding demographic characteristics and SUI will be performed.
15819588|NCT04288635|Biological|Whole blood samples|Whole blood samples at admission, from day one to three after admission
15819589|NCT04288622|Other|Weekly standardised, personalised feedback|The ESM-F group will receive standardised ESM-derived feedback immediately followed the weekly ESM data collection procedure, totalling 6 times in the entire intervention period. The feedback will be provided by the researcher in the format of written report and verbal explanation. The feedback on participants' momentary affective state in specific daily life contexts and the association with depressive symptoms will be given. The changes in positive affect level and the number of depressive complaints over the course of the ESM intervention will be shown.
15819590|NCT04288609|Other|Intendu|Cognitive remediation using VR adaptive platform for response inhibition, self-initiation, cognitive flexibility, sustained attention, divided attention, working memory, planning, persistence.
15819591|NCT04288609|Other|Paper and Pencil cognitive remediation training|Cognitive remediation using paper and pencil tasks for response inhibition, self-initiation, cognitive flexibility, sustained attention, divided attention, working memory, planning, persistence.
15819592|NCT04288596|Other|Participants undergoing ACHD intervention|Participants will receive standard of care for their ACHD intervention.
15819594|NCT04288570|Procedure|suture anchor socket creation with drill|suture anchor socket creation with drill
15819595|NCT04288544|Dietary Supplement|Microalgae|Open, monocentric intervention study in crossover design
15819596|NCT04288544|Dietary Supplement|Omega-3-fatty acid capsule|Open, monocentric intervention study in crossover design
15819597|NCT04288544|Dietary Supplement|sea fish|Open, monocentric intervention study in crossover design
15819598|NCT04288531|Dietary Supplement|Iodine supplementation|Recommendation, issued by the National Health Authorities, on supplementing with iodine (200 ug/day) women during preconception, pregnancy and lactation.
15819599|NCT04288518|Diagnostic Test|SPECT with 99mTc-1-thio-D-glucose|One single intravenous injection of 99mTc-1-thio-D-glucose, followed by gamma camera imaging directly postinjection and after 2, 4, 6 and 24 hours.
15819600|NCT04288505|Diagnostic Test|VIRTUAL REALITY application|application on virtual reality headset
15819601|NCT04288492|Behavioral|Respiratory biofeedback|Repeat the inspiration and exhalation breaths for a fixed period of time using a biofeedback device (ResCalm)
15819602|NCT04288479|Behavioral|Single high-intensity interval training session|10 minutes warming up at low-to-moderate intensity, 8x30 seconds high intensity interval training with fetal heart rate measurement after each 30 second work-bout, 2 minutes recovery at low-to-moderate intensity. Continuous monitoring of maternal heart rate.
15819603|NCT04288466|Dietary Supplement|maltodextrin|maltodextrin solution 450ml
15819604|NCT04288453|Behavioral|Engagement in a 8-week community-based activity program|"Participants engage in a 8-week community-based activity program of their choice. In order to engage in the selected activity, an Occupational Therapist (OT) will meet with each youth in their home. Using the PREP 5 steps (Make goals; Map out a plan; Make it happen; Measure the process and outcomes; Move forward) the youth will choose a community program. The OT will then search for the appropriate program, identify and remove potential environmental barriers for participation in that activity (e.g., accessibility, equipment) and educate program instructors regarding the youth's specific needs. This process, which includes up to 12 hours of working with the OT, will set the stage for enrolment of the youth in a community program for a period of 8 weeks - the actual intervention phase.
~Other Names:
~• Pathways and Resources for Engagement and Participation"
15819605|NCT04288440|Procedure|Surgery|Removal of epiretinal membrane and ILM
15819606|NCT04288440|Device|Vitrectomy machine|Pars plana vitrectomy
15819607|NCT04288427|Drug|Finasteride|Patients who are candidates to receive 5ARI therapy, Finasteride, for clinical medical management of lower urinary tract symptoms will begin treatment once deemed eligible. They will be assess every 6 months for changes in urinary symptom scores and their responsiveness to the Finasteride treatment will be assessed at the 12-month time point. MRIs of prostate taken at the start of study and at the 3 year time point will assess prostate size and changes in size as well as degree of inflammatory changes. Gene expression of SRD5A2 as well as methylation pattern will be tested on prostate tissue samples, where hormonal androgen/estrogen levels will also be assessed as they are in blood samples.
15819608|NCT04288414|Diagnostic Test|functional near-infrared spectroscopy|Functional near-infrared spectroscopy (fNIRS) is a non-invasive method that can evaluate the brain function by measuring the change in brain metabolic activity and hemodynamics during a given task with near-infrared spectroscopy.
15819609|NCT04288388|Behavioral|massage group|In recent years, in the literature, it is known that many non-pharmacological techniques are applied to reduce the pain of birth in addition to local anesthesia. One of these nonpharmacological methods is the application of pressure to LI4 point on hand with ice.
15819610|NCT04288375|Radiation|Intensity-modulated radiation therapy (IMRT)|The prescribed dose of radiations for all patients will be 50 Gy in 25 fractions. 6MV energy photons will be used. Multi-beam IMRT plans, utilizing dynamic multileaf collimation, will be created based on the target tissue coverage and normal tissue avoidance.
15819611|NCT04288362|Other|Intervention Group|Participants in this arm will undergo the new care model for management of diabetes mellitus polyclinics.
15819612|NCT04288362|Other|Control Group|Participants in this arm will continue to undergo the existing care model for management of diabetes mellitus in the polyclinics.
15819613|NCT04288349|Procedure|perineal block with usage of one of solutions|Perineal block using solution of ropivocaine and epinephrine for the first group was performed. Anococcygeal ligament is infiltrated with 10 ml of the solution after the intracutaneous infiltration in 2 cm from the anus. Ten ml of the solution is injected in ischiorectal fat on each side. The needle is orienteered at the angle of 45 degrees cranially and laterally, and to the surface what allows the surgeon to anesthetize the deep branches of the pudendal nerve. In addition, 10 ml of solution is injected transdermal on the front edge of the anus with further subcutaneous infiltration on each side of the anus to provide anesthesia to the nerve branches laying more superficial. The total amount of the injected solution is 50 ml.
15819614|NCT04288349|Drug|epinephrine + ropivacaine +saline|epinephrine + ropivacaine +saline
15819615|NCT04288349|Drug|epinephrine + saline|epinephrine + saline
15819616|NCT04288336|Other|Food Diary|Ancillary studies
15819617|NCT04288336|Other|Preventative Dietary Intervention|Follow intermittent fasting
15819618|NCT04288336|Other|Questionnaire Administration|Ancillary studies
15819619|NCT04288323|Drug|Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid|This study involves an on-label use of Gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid for the ....
15819620|NCT04288297|Procedure|distal minimally invasive chevron osteotomy|With an electric motor-driven machine the resection of the medial eminence as well as a V-shaped osteotomy was performed in hallux valgus patients. Intraoperative fluoroscopy was used to identify the ideal osteotomy site and to control the Intervention. Fixation of the metatarsal head was achieved with a screw or with a K wire. Residual bone ridges were reamed and bone debris washed out.
15819621|NCT04288284|Procedure|Curative resection of colorectal cancer|
15819654|NCT04287972|Procedure|DPC|The anterior fat pad is dissected until the left crura is visible, pars flaccida is open and the right crura exposed. Phreno-oesophageal ligament is sectioned starting from the right crura. Posterior and anterior vagal nerve are recognized before the oesophageal dissection. An intra-abdominal oesophagus lengths of 2 or 3 cm is obtained in order to reduce tension. Left and right crura are sutured with 2 or 3 non absorbable 2-0 stitches; an additional anterior stitch is posed if necessary to calibrate hiatus size without oesophageal deviation.
15820146|NCT04283656|Other|Placebo|Placebo for one dose, daily
15819622|NCT04288271|Behavioral|Adherence Intervention|"Intervention:
~Adherence Support Team (patient, parent or a significant other, Coach)
~Standardized educational videos on immunosuppressive medications, rejection, and improving adherence
~Identification of adherence barriers, self-efficacy for medication-taking, and allocation of treatment responsibility
~'Action-Focused Problem-Solving' to address barriers selected as most important by the patient
~Device:
~Electronic pillbox monitoring with text message and/or audio/visual dose reminders and access to e-pillbox website
~Feedback of electronic monitoring data at increasing intervals between initiation of the intervention at 4-week and exit at 14-week."
15819623|NCT04288271|Other|Healthy living education intervention|"Iintervention:
~Standardized educational videos on immunosuppressive medications, rejection, and improving adherence
~Healthy living topic discussion at increasing intervals between 4-wk and 14-wk visits
~'Action-Focused Problem-Solving' to address barriers on healthy living topic selected by the patient
~Device:
~Electronic adherence monitoring without dose reminders or feedback (enrollment to 14w)
~Prolonged use of the e-pillbox with enhanced features (text message, email, or visual cue dose reminders) and access to e-pillbox website for up to 8 weeks (from 14w to 22w visit)."
15819624|NCT04288258|Behavioral|Telehealth-Based Health and Wellness Program (POWERS-TBI)|The treatment program is interactive and will be delivered via the internet, along with ongoing telephone health coaching calls designed to motivate, problem-solve challenges, reinforce skills learned, and prevent relapse.
15819625|NCT04288245|Device|Active Vagus Nerve Stimulation|Stimulation of the vagus nerve that is paired with upper extremity rehabilitation. VNS stimulation as described in the current study consists of 0.5 s trains of 0.8 mA 100 µs biphasic pulses delivered at 30 Hz. Stimulation trains are delivered only during rehabilitation.
15819626|NCT04288245|Device|Placebo Vagus Nerve Stimulation|During Phase 1 of the study, the placebo group will receive a minimal amount of stimulation that fails to sufficiently activate the nerve, unknown to the participant and therapists. All participants will receive active stimulation during the Phase 2 open-label portion of the study.
15819627|NCT04288232|Drug|Aflibercept Injection [Eylea]|Intravitreal aflibercept Injection 2.0mg/0.05 ml
15819628|NCT04288219|Device|Non-Invasive Positive Pressure Ventilation|Continuous positive airway pressure delivered by face mask at 10cmH2O
15819629|NCT04288219|Drug|Nifedipine|Nifedipine 30mg, Pharmacotherapy
15819630|NCT04288219|Other|supplemental oxygen|supplemental oxygen
15819631|NCT04288206|Drug|Cefazolin|intravenous cefazolin is being evaluated as a pre-operative prophylactic antibiotic measure with primary outcome being post operative infection rate among participants.
15819632|NCT04288206|Drug|normal saline|intravenous normal saline placebo
15819633|NCT04288193|Drug|Recommendation to Deprescribe|Recommendation to Deprescribe
15819634|NCT04288180|Other|No intervention|There will be no intervention in this study. Adults with social anxiety disorder will complete research assessments related to fear and safety learning.
15819635|NCT04288167|Diagnostic Test|Sample collection|Samples of urine and saliva will be collected from participants using customary sample collection means.
15819636|NCT04288154|Device|EMS Device On|The EMS Device will turned on during exercise as opposed to it being turned off for control group.
15819637|NCT04288154|Other|EMS Device Off|The EMS Device will turned off during exercise as opposed to it being turned off for control group.
15819638|NCT04288141|Other|Acquisition of blood samples and tumour tissue samples (biopsies)|Acquisition of blood samples and tumour tissue samples (biopsies) in a sequential manner as participants proceed through HER2-directed therapy as prescribed by their oncologist.
15819639|NCT04288128|Procedure|Lumbar puncture|Each participant will undergo lumbar puncture at first visit (M0) and last visit (M12)
15819640|NCT04288128|Other|Magnetic Resonance Imaging (MRI)|Each participant will undergo scanning at 3 visits (M0, M6 and M12)
15819641|NCT04288115|Drug|Levothyroxine|Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.
15819642|NCT04288115|Other|Placebo|Participants will be instructed to start the study medication the day after randomization. The study medication will be taken orally once a day.
15819643|NCT04288102|Biological|UC-MSCs|3 does of UC-MSCs(4.0*10E7 cells per time) intravenously at Day 0, Day 3, Day 6.
15819644|NCT04288102|Biological|Saline containing 1% Human serum albumin（solution without UC-MSCs）|3 does of placebo（intravenously at Day 0, Day 3, Day 6）
15819645|NCT04288089|Drug|Palbociclib (75, 100, 125 milligram [mg])|Palbociclib orally.
15819646|NCT04288089|Drug|H3B-6545 (300, 450 mg)|H3B-6545 orally.
15819647|NCT04288076|Other|PEEP Titrated Mechanical Ventilation|Subjects will receive a sequential, step-wise increase in positive end-expired pressure from 5 cmH2O to 15 cmH2O and back down to 5 cmH20. Pleural pressure and intracranial pressure will be measured at each increment. PEEP will be increased by increments of 5 cmH2O. The physiologic measurements will be obtained at regular intervals (within 5 minutes at each PEEP level) throughout the PEEP titration period. The mode of mechanical ventilation (pressure or volume control), inspiratory time and fraction of inspired oxygen (FIO2) will be determined by the critical care team caring for the patient. In the event that PEEP is set > 5 cmH2O, measurements will be obtained from that starting point and increased to a maximum of 15 cmH2O. At the completion of the study patients will be returned to the PEEP level they were on prior to titration of the ventilator.
15819648|NCT04288037|Diagnostic Test|fetal heart rate variability|observational study. no intervention
15819649|NCT04288024|Behavioral|Weight-shifting training|"Postural task: Participants are standing with their weak side on the force plate. During the task, they wight-shift from side to side ranging from 10 to 90 percent of their body weight.
~Suprapostural task: Participants hold a tray with their arms beside the body, 90 degrees of elbow flexion. They rotate the tray left and right for 45 degrees respectively.
~During their task, participants should weight-shift and rotate the tray at the same time."
15819650|NCT04287985|Drug|Dose-Placebo|Unit Dose Strength - 0.9%.
15819651|NCT04287985|Drug|Low Dose-VIS649|Dose Level = Low
15819652|NCT04287985|Drug|Medium Dose-VIS649|Dose Level = Medium
15819653|NCT04287985|Drug|High Dose-VIS649|Dose Level = High
15819691|NCT04287777|Drug|Placebo|Topical administration of Placebo (ointment) TID during 7 days
15819721|NCT04287478|Biological|Bacteriophage Therapy|Bacteriophage therapy will be personalized for each patient dependent on phage susceptibility testing
15819722|NCT04287452|Other|Control|Control
15819655|NCT04287972|Procedure|LSG|After omental section close to gastric insertion, gastric stapling is realised with triple line endo stapler (normally 5 or 6 re-loads). The gastrectomy begins 5-6 cm from the pylorus; gastric fundus is totally resected keeping a distance of 5-10 mm from oesophagus. Any bleeding on staple line is controlled with surgical clips or coagulator.
15819656|NCT04287959|Device|High flow nasal cannula support|airvo2 highflow devices will be used.
15819657|NCT04287946|Device|Ablation|Ablation of a single-side of the greater splanchnic nerve
15819658|NCT04287933|Device|Drain insertion|insertion of a drain
15819659|NCT04287920|Drug|Acomprosate|Acamprosate will be administered orally and will be dosed at 333 mg three times a day, if tolerated it will be increased to 666 mg three times a day. Acamprosate will be administered for a total of 3 months
15819660|NCT04287907|Device|Monitor Group|Use of colorimetric end tidal CO2 to guide provider during provision of mask ventilation, where colour change indicates effective breaths
15819661|NCT04287894|Drug|Durvalumab|The IP will be given to the patient as long as there is a clinical benefit, in invertigator's judgment. Per day, 1500 mg
15819662|NCT04287894|Drug|Tremelimumab|Per day 75mg
15819663|NCT04287894|Drug|Pemetrexed|500 mg/m2 on day 1 every 3 weeks for 2 cycles
15819664|NCT04287894|Drug|Cisplatin|6 mg / m2 on day 1 every 3 weeks for 2 cycles
15819665|NCT04287894|Radiation|chemo radiotherapy|Once-daily fraction, 2 Gy per fraction. Total dose is 60 Gy.
15819666|NCT04287894|Procedure|Resection|After CIT-CRT
15819667|NCT04287881|Genetic|Methylenetetrahydrofolate reductase (MTHFR) deficiency|To investigate the incidence of MTHFR deficiency in patients with adult-onset epileptic seizures and diagnosed ischemic stroke
15819671|NCT04287855|Drug|Isatuximab|Isatuximab by IV route - Cycle 1 : 10mg/kg on days 1, 8, 15 and 22 per 28 days cycle. After cycle 1 : 10mg/kg on days 1 and 15 per 28 days cycle
15819672|NCT04287855|Drug|Carfilzomib|Carfilzomib by IV route - Cycle 1 : 20/27 mg/m² on days 1-2, 8-9, 15-16 per 28 days cycle. Cycle 2-13 : 56mg/m² on days 1, 8, 15 per 28 days cycle. After cycle 13 : 56mg/m² on days 1 and 15 per 28 days cycle.
15819673|NCT04287855|Drug|Pomalidomide|Pomalidomide by oral route - Cycle 1-2 : 3mg on days 1 to 21 per 28 days cycle. After cycle 2 : 4mg on days 1 to 21 per 28 days cycle.
15819674|NCT04287855|Drug|Dexamethasone|Dexamethasone by oral route - Cycle 1-13 : 40/20 mg on days 1, 8, 15 and 22. Cycle 2-13 : 56mg/m² on days 1, 8, 15 per 28 days cycle. After cycle 13 : 56mg/m² on days 1 and 15 per 28 days cycle.
15819675|NCT04287842|Drug|Desflurane|Desflurane anesthesia is introduced. This provides complete suppression of animal responses to pain, fixation, tracheal intubation and cardiac arrest.
15819676|NCT04287842|Drug|Sevoflurane|Desflurane anesthesia is introduced. This provides complete suppression of animal responses to pain, fixation, tracheal intubation and cardiac arrest. After fixation of the animal in the supine position trachea is intubated and mechanic ventlation with air using an animal respirator is performed. Cardiac arrest is induced by intrathoracic clamping of the supracardiac bundle of vessels by means of a special hook. Period of cardiac arrest and absence of ventilation lasts 10 min. The animal is then resuscitated by means of chest compressions and mechanichal ventilation with air. Cardiac activity and systemic blood circulation recovers within 1 min; spontaneous respiration will be resumed after a period of 4-6 min.
15819677|NCT04287842|Procedure|Cardiac arrest|Cardiac arrest is induced by intrathoracic clamping of the supracardiac bundle of vessels by means of a special hook. Period of cardiac arrest and absence of ventilation lasts 10 min. The animal is then resuscitated by means of chest compressions and mechanichal ventilation with air. Cardiac activity and systemic blood circulation recovers within 1 min; spontaneous respiration will be resumed after a period of 4-6 min.
15819678|NCT04287829|Drug|Pembrolizumab|Infusion
15819679|NCT04287829|Drug|Lenvatinib|Capsule
15819680|NCT04287816|Other|Zero hard-boiled egg at 0 h|No eggs will be consumed on test day along with spinach consumption
15819681|NCT04287816|Other|One hard-boiled egg at 0 h|One egg will be consumed on test day along with spinach consumption
15819682|NCT04287816|Other|Two hard-boiled eggs at 0 h|Two eggs will be consumed on test day along with spinach consumption
15819683|NCT04287816|Other|Three hard-boiled eggs at 0 h|Three eggs will be consumed on test day along with spinach consumption
15819684|NCT04287816|Other|One hard-boiled egg at 3 h|One egg will be consumed on test day three hours after spinach consumption
15819685|NCT04287816|Other|One hard-boiled egg at 0 h + One hard-boiled egg at 3 h|Two eggs will be consumed on test day: one along with spinach consumption and the other one three hours after spinach consumption
15819686|NCT04287803|Drug|Methoxyflurane|Methoxyflurane 3mls will be self administered by patients meeting the inclusion criteria with acute traumatic pain scores >=4
15819687|NCT04287790|Behavioral|audit and feedback, educational meetings, and academic detailing to promote medication receipt|Our implementation intervention will incorporate the following strategies: 1) Formation of an alcohol-related care working group. This voluntary working group will consist of members of the research team and volunteer health professionals from YNHH. The group with supervise and support the other intervention components. 2) We will develop medication for alcohol use disorder marketing (posters and buttons) materials and educational (pamphlet) materials and distribute these materials to health professionals. 3) Building on the existing infrastructure and collaboration, the research team will assist in revising existing alcohol-related care daily monitoring systems to support auditing and feedback on the adoption of medications for alcohol use disorder at YNHH. 4) The research team will hold educational meetings and educational outreach visits (academic detailing) when invited during regular noon conferences and team meetings.
15819688|NCT04287790|Drug|Acamprosate, naltrexone, or disulfiram|Increased receipt of medications for alcohol use disorder facilitated by the implementation intervention.
15819689|NCT04287777|Drug|Mupirocin gel|Topical administration of Mupirocin gel 20 mg/g BID for 7 days
15819690|NCT04287777|Drug|Mupirocin ointment|Topical treatment of Mupirocin ointment 20 mg/g TID for 7 days
15819692|NCT04287751|Device|CheckMeO2 Oximeter|Simultaneous recording with a current standard oximeter (Minolta i300) and prolonged recording device. Comparison of data from first night and incidence of obstructive sleep apnoea identified from additional nights of recording identified.
15819693|NCT04287738|Behavioral|Navigated Care|Telephone-based collaborative dementia care was delivered by a trained care team navigator, who provided education, support and care coordination with a team of dementia specialists (advanced practice nurse, social worker, and pharmacist). For more details, please see references below.
15819694|NCT04287725|Device|exercise + photobiomodulation therapy|Treatment sessions will be provided twice a week for 6 weeks (totaling 12 sessions) with participants receiving either placebo or active PBMT + exercise protocol.
15819695|NCT04287712|Diagnostic Test|Plasma lipids|Plasma lipids were detected by an Ultimate 3000 ultra-high-performance liquid chromatography (UHPLC) system coupled with Q-Exactive MS (Thermo Scientific) . Then a detection model was built based on plasma lipids using machine learning algorithm.
15819696|NCT04287699|Other|labor dance|The pregnant women and their spouses/partners who wanted to perform the practice were asked to inform the researcher when the labor started. The researcher stayed with the pregnant women and their spouses during the practice and labor process. The pregnant women started to dance with their spouses during the active phase of the labor process accompanied by meditation music in a dim, silent environment. The spouse or partner massaged the pregnant woman's sacral area while dancing.
15819697|NCT04287686|Drug|Recombinant human angiotensin-converting enzyme 2 (rhACE2)|In this study, the experimental group will receive 0.4 mg/kg rhACE2 IV BID for 7 days.
15819698|NCT04287673|Other|Rehabilitation involving strongly the trunk|The Rehabilitation involving strongly the trunk (RIST) leaded by a physiotherapist was based on exercises in different postures performed by the child each day that strongly involve the trunk to cope with balance.
15819700|NCT04287647|Device|Transpyloric stent|See arm/group descriptions
15819701|NCT04287647|Other|Sham|Sham
15819702|NCT04287634|Other|Segmental Mobilization|Hot fermentation =10 minutes Soft tissue mobilization =5 minutes Targeted segmental mobilization= 3 sets of 10 repetitions Home plan exercise= cervical muscles stretching, postural care.
15819703|NCT04287634|Other|Entire Spine Mobilization|Hot fermentation=10 minutes Soft tissue mobilization=5 minutes Entire spine mobilization =3 sets of 10 repetitions Home plan exercises=cervical muscles stretches, postural care.
15819704|NCT04287621|Drug|DUPIXENT®|There is no investigational product provided by the study sponsor and no therapeutic intervention regulated by this protocol. As a condition for eligibility, patients are required to initiate DUPIXENT® for asthma, according to the country-specific prescribing information, prescribed by their physician as part of their normal care (ie, not for the purpose of enrolling in the registry). Once patients enter the study, there are no protocol requirements regarding DUPIXENT® or any other treatments.
15819705|NCT04287608|Drug|dupilumab|No investigational agents will be provided to study patients, and no specific treatment is required during the study. DUPIXENT®-treated patients will receive DUPIXENT as standard of care for the treatment of their AD, as prescribed by their physician. However, continuous treatment with dupilumab for at least 8 weeks is required as a condition for eligibility.
15819706|NCT04287595|Other|Inhalation aromatherapy with orange essential oil|
15819707|NCT04287582|Other|Electromyographic device|An 8-channel surface EMG system (DELSYS Trigno Wireless System) will be used to measure signals from muscles during stair climbing activity by surface electromyography measurements.Surface EMG measurements will be carried out during stair climbing activity without any intervention in the body. Surface EMG electrodes will be placed bilaterally in the vastus lateralis, biceps femoris, tibialis anterior and gastrocnemius medialis muscles.
15819708|NCT04287569|Device|Record during endoscopy of video-endoscopy sequences and reflectance|Record of video-endoscopy sequences and reflectance, during endoscopy with biopsy.
15819709|NCT04287556|Diagnostic Test|In vitro contracture test (IVCT)|In vitro study of muscle contraction after exposure to different substances (caffeine and halothane).
15819710|NCT04287556|Diagnostic Test|In vitro test of hypermetabolism in B lymphocytes|In vitro study of the activation of lymphocytes B after being incubated with a cocktail of primary antibodies and measuring the acidification in response to the RyR1, 4-CmC agonist, using ryanodine as a positive control.
15819711|NCT04287556|Diagnostic Test|Genetic test|Analysis of genes related to MH (CACNA1S and RYR1).
15819712|NCT04287543|Drug|Melatonin|25 mg of melatonin gel at noon and 25 mg of melatonin gel 30 minutes before sleeping for 12 months
15819713|NCT04287543|Drug|Placebos|25 mg of placebo gel at noon and 25 mg of placebo gel 30 minutes before sleeping for 12 months
15819714|NCT04287530|Dietary Supplement|Poly-unsaturated fatty acids supplementation|Daily supplementation with 6 daily PUFA (Omega-3 and Omega-6) chewable capsules from the beginning (immediately after the pre-testing session) to the end (immediately before the post-testing session) of the observation period, for a total of three months.
15819715|NCT04287530|Behavioral|Neuropsychological intervention|"Rehabilitation protocol adopted at IRCCS E. Medea (remote intervention delivered through the Tachidino platform), delivered during four weeks, starting two months after the pre-testing session."
15819716|NCT04287530|Dietary Supplement|Placebo|Daily supplementation with 6 daily Placebo (triglycerides) chewable capsules from the beginning (immediately after the pre-testing session) to the end (immediately before the post-testing session) of the observation period, for a total of three months.
15819717|NCT04287517|Device|Capacitive-Resistive Therapy|Capacitive-resistive diathermy therapy heats deep tissues by transferring energy through radiofrequency waves.
15819718|NCT04287504|Diagnostic Test|SavvyCheck Vaginal Yeast Test|Point-of-care test for the detection of vaginal candidosis
15819719|NCT04287504|Diagnostic Test|OSOM BVBLUE Test|Point-of-care test for the detection of bacterial vaginosis
15819720|NCT04287491|Other|Oculus Go Virtual Reality System|The VR system will provide a 3D environment that provides distracting stimulus. Participant will put on the Oculus Go VR system headset 1-2 minutes prior to out-patient bedside procedure up to the completion of procedure which takes typically 3-5 minutes.
15819724|NCT04287439|Behavioral|Progressive muscle relaxation|Patients will receive a training session for progressive muscle relaxation exercise They will practice it daily at their home during 12 weeks. Patients will be called daily to ensure that patients perform the intervention according to the study protocol, and to assess their study-adherence.
15819725|NCT04287439|Behavioral|Mindfulness meditation|Patients will receive a training session for mindfulness meditation. They will practice it daily at their home during 12 weeks. Patients will be called daily to ensure that patients perform the intervention according to the study protocol, and to assess their study-adherence.
15819726|NCT04287439|Other|Attention matched control|Patients will receive a training session focusing on focusing on the anatomy and physiological functions of the pancreas, general information about type 2 diabetes including signs, complication, and treatment methods
15819727|NCT04287426|Drug|Rocuronium 0.6 mg/kg|Rocuronium 0.6 mg/kg is compared to patients with 2 µg/kg remifentanil
15819728|NCT04287426|Drug|Remifentanil 2 µg/kg|Rocuronium 0.6 mg/kg is compared to patients with 2 µg/kg remifentanil
15819729|NCT04287413|Behavioral|Physiotherapist-led primary care model for back pain|"Assessment and screening: taking a history; screening for red flags, comorbidities, and risk factors of ongoing pain and disability; physical examination.
~Brief individualized intervention at the first visit: effective communication, cognitive reassurance, a few exercises, and advice/strategies to stay active.
~Health services navigation: PT assistance with navigating healthcare services based on the assessment findings. First, red-flags requiring emergency or urgent referrals. Next, comorbid conditions that would benefit from care from other healthcare providers. Finally, referral to PT (if appropriate).
~Providing additional physiotherapy care to people with an unmet need: Additional physiotherapy care will be provided to patients who have an identified need for physiotherapy but no physiotherapy coverage through private or government health insurance plans."
15819730|NCT04287413|Behavioral|Usual care|The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.
15819731|NCT04287387|Drug|Glucophage 500Mg Tablet|0.5g three times daily
15819732|NCT04287387|Drug|Acarbose Tablets|50mg three times daily
15819733|NCT04287387|Drug|Sitagliptin tablet|100mg once daily
15819734|NCT04287387|Drug|Dapagliflozin Tablet|10mg once daily
15819735|NCT04287387|Drug|Pioglitazone Tablets|30mg once daily
15819736|NCT04287387|Drug|Glimepiride Tablets|2mg once daily
15819737|NCT04287374|Behavioral|Multi-component Well-being Intervention|The intervention asks participants to complete exercises based on three different skills. These skills include cognitive restructuring, gratitude and behavioral activation. After completing the program, participants will pick their favorite exercise to complete on a weekly basis for homework. In order to increase compliance with the homework, participants will complete a short plan in which they will identify when, where and with who they will complete the homework. The whole intervention takes approximately 20-30 minutes to complete.
15819738|NCT04287374|Behavioral|Study Skills|Participants are taught three different study skills/strategies. They are asked to make a plan to continue using these strategies after completing the intervention. The whole intervention takes approximately 20-30 minutes to complete.
15819739|NCT04287361|Other|Efficacy of intravenous clonazepam|Efficacy of intravenous clonazepam
15819740|NCT04287348|Drug|Brolucizumab 6 mg solution for intravitreal injection|All consenting, enrolled patients (irrespectively of maximum recurrence-free interval under aflibercept pretreatment) will receive an intravitreal injection of brolucizumab 6 mg at baseline (week 0), at week 4 and each of the following treat and extend visits. At each visit all patients will undergo an OCT assessment. For all patients extension of treatment intervals is only possible 2-week-stepwise, e.g. 4, 6, 8 weeks etc.
15819741|NCT04287335|Diagnostic Test|Multitarget stool FIT-DNA test - ColoClear|Multitarget stool FIT-DNA test
15819742|NCT04287335|Diagnostic Test|FIT|fecal immunochemical test
15819743|NCT04287335|Procedure|Colonoscopy|diagnostic colonoscopy
15819744|NCT04287322|Behavioral|Tactile-kinesthetic stimulation|"Tactile-kinesthetic stimulation involved three sessions per day; morning, afternoon, and evening for 10 days starting day 3 of life (initial contact). The stimulation included three phases; Phase 1: With neonates in prone position, moderate pressure was used to provide 12 strokes with palms of the hands, each stroke lasting 5 seconds. The strokes were provided in each area as follows: head, neck, shoulders and back.
~Phase 2: In supine position, twelve moderate pressure strokes with palms of the hands, 5 seconds each, were provided in each area as follows:forehead,cheeks,chest, abdomen, upper limbs (each separately), lower limbs, palms and soles.
~Phase 3: Kinesthetic stimulation was done for 5 minutes. The intervention comprised five passive flexion and extension movements of each large joint."
15819745|NCT04287322|Behavioral|Recorded maternal voice|Following informed written consent from mothers,maternal voice was recorded (5 minutes talking to her baby and 10 minutes singing) using Philips Electronics, SA2RGA04KS, Netherlands. Recorded voice was played back inside the incubator or cot via micro audio system, which has been validated for safety and feasibility in previous studies (Doheny et al., 2012. Preterm neonate lay in supine/lateral position and recorded maternal voice was played for 15 minutes three times a day (morning, afternoon, evening) starting on day 3 of life up to day 12 of life (10 days).
15819746|NCT04287309|Other|CAR-T cells|CD19 targeted CAR-T treatment
15819747|NCT04287296|Behavioral|Wakey!|Everyone who has downloaded the app will receive a 9-minute morning show as an alternative to an alarm clock every Mon-Fri for 12 weeks. The show is presented by a cast of presenters who appeal to the target demographic. The intervention content is theory and evidence led, drawing on approaches from cognitive and third-wave psychotherapies, positive psychology interventions (such as those based on resilience training and growth mindset), and lifestyle mental health interventions. Additional content will be provided on the app to support the theory and techniques that are covered in the show. Fun content will also be posted in an ad-hoc manner that complement the shows or relate to cultural dates and aim to increase engagement. Wakey! will avoid any polarising topics such as politics, religion and folk science. There are several features beside the show itself: a moderated live chat between 6-9AM, feedback for users (e.g. how many days they have seen the show, current energy levels).
15819748|NCT04287283|Other|Hyperbaric Oxygen|40-60 daily hyperbaric sessions, 5 days per week. Each session consists of 90 minutes exposure to 100% oxygen at 1.5-2 ATA.
15819749|NCT04287270|Other|Assesment|Evaluations which explained in the arms section will be made as described.
15819750|NCT04287257|Device|Fracture Healing Patch (FHP)|The Fracture Healing Patch (FHP) is an external silicone patch that contains inside micro-electronic modulus, which generates a pulsed electromagnetic field (PEMF) to enhance and improve fracture healing. The FHP is placed under the cast at the fracture site. Throughout the treatment period the FHP produces a pulsed electromagnetic field. The FHP houses a battery, a microelectronic module and a coil that produce the PEMF.
15819751|NCT04287244|Device|Transcutaneous Spinal Direct Current Stimulation|tSDCS will be administered through a pair of conductive rubber electrodes covered by saline soaked sponges (35 cm2). The current will be delivered continuously at 2 mA for 30 min through a battery-driven constant-current stimulator (Sooma Oy, Helsinki, Finland).
15819752|NCT04287231|Device|Transcranial direct current stimulation|This instrument will be used to induce post-stroke motor recovery, two different monocephalic montages are typically used to restore excitability in the lesioned hemisphere and to down regulate excitability of the non-lesioned hemisphere and rebalance Interhemispheric inhibition. each participant will undergo a 20-minute period of tDCS, applied at 2 mA through a pair of saline-soaked surface sponge electrodes (35 cm2).
15819753|NCT04287218|Behavioral|TG-iConquerFear|The theoretical frame of iConquerFear is based on the Common-Sense Model of illness, the Self-Regulatory Executive Function model and Relational Frame Theory. The intervention includes elements of attention training, increasing metacognitive awareness, acceptance & mindfulness, promotion of appropriate screening behavior, and values-based goal setting. The electronic platform comprises 5 modules containing educational text, interactive exercises, short videos featuring doctors, therapists and patients' perspectives.
15819754|NCT04287218|Behavioral|aTAU|Active control group
15819755|NCT04287205|Drug|Dydrogesterone|79 women, aged between 18 and 45 years, who were examined at our tertiary gynecology outpatient clinic between April 2019 and March 2020, with surgically diagnosed endometriosis, were included in this study. They received a treatment with 5 mg dydrogesterone administered orally twice daily for 21 days; from the 5th to 25th day of each menstrual cycle, for a total of 6 months. They were evaluated pre- and posttreatment in terms of their age, parity, and body mass index (BMI). Female Function Sexual Index (FSFI) and visual analogue scale (VAS) scores were recorded pre- and posttreatment
15819756|NCT04287192|Other|Digital Bridge:Tool Intervention|Our Digital Bridge is an integration of the Care Connector and ePRO technologies that will support care transitions by: 1) inviting PCPs to access Care Connector while the patient is in hospital, allowing for asynchronous communication via the messaging feature for proactive discharge planning, 2) facilitating the inclusion of inter-professional recommendations in the discharge module (e.g. diet and mobility) typically missing from traditional physician generated discharge summaries, 3) electronic generation of PODS for use in patient-centred discharge teaching, 4) providing patients electronic access to PODS post discharge to facilitate use of information at home, 5) adoption of digital enabled goal-oriented process to engage patients and families in discharge process, and 6) providing ongoing self-management support for patients using ePRO for the vulnerable period 6 months post discharge.
15819757|NCT04287179|Drug|Semaglutide|Dose gradually increased over 12 weeks to 2.0 mg, followed by a 5 week maintenance period.
15819758|NCT04287153|Device|Cryotherapy on abdomen and saddlebags|Application of variable temperature (-10°c to -7°c) on the treated areas using the cryotherapy device FG660L-006 (Beijing ADSS Development CO., Ltd)
15819759|NCT04287140|Other|Bolus fluid administration|1000 ml of 0.9% normal saline bolus over one hour
15819760|NCT04287114|Behavioral|Acute exercise|Acute exercise with different exercise intensities
15819761|NCT04287101|Other|Post-operative PT and OT|Strengthening exercise, range-of-motion exercise, functional training, balance training, adjustment for assistive devices, adaptation and modiﬁcation of the home environment, and patient/caregiver education
15819762|NCT04287088|Diagnostic Test|A shared decision making|Based on prostate cancer risk calculation (age, usage of 5-ARI medication, baseline PSA, IMPROD bpMRI Likert, prostate volume) a shared decision making whether to perform prostate biopsies or not
15819763|NCT04287075|Procedure|Surgical Management of Neuroma|Surgical procedures targeted to treat the source of a participant's chronic, neuropathic pain
15819764|NCT04287062|Drug|Suvorexant|Dual orexin receptor antagonist
15819765|NCT04287062|Drug|Placebos|Weight and color matched placebo
15819766|NCT04287049|Drug|Azithromycin|Azithromycin 250 mg PO daily
15819767|NCT04287036|Device|JJVC Investigational Contact Lens|TEST
15819768|NCT04287036|Device|1-DAY ACUVUE® DEFINE® Radiant Sweet™|CONTROL
15819769|NCT04287023|Other|individual physical therapy|cardiovascular warm-up activities, stretching exercises, strengthening exercises, functional, gait and balance training, recreational games and ended with relaxation exercises - individual
15819770|NCT04287023|Other|group physical therapy|cardiovascular warm-up activities, stretching exercises, strengthening exercises, functional, gait and balance training, recreational games and ended with relaxation exercises - groups of 10 patients
15819771|NCT04286997|Device|GRAIL population|each subjects included in the intervention group will receive 20 GRAIL sessions, aimed to the walking pattern improvement, associated with 20 traditional physiotherapy sessions, aimed to the stabilization of the trained competences
15819772|NCT04286984|Other|unified protocol of Patient Blood Management measure|upPBM description: After performing a laboratory work-up 2 to 4 weeks before surgery, preoperative iron supplementation in case of iron deficiency anemia at least 7 days before surgery was recommended. Preoperative anemia was defined by a Hb level < 13 g/dL for both sexes. In anemic patients, iron status study was recommended and iron supplementation with intravenous iron was indicated if Hb<12g/dL and/or ferritin <300 mg/l. Intravenous iron (ferric sucrose or carboxymaltose) was administrated with the goal of recovering iron deficit, calculated using the Ganzoni formula or by the simplified strategy, only available for ferric carboxymaltose. Recommended transfusion triggers were: Hb < 9 g/dL for patients with risk factors and/or anemia symptoms; and Hb < 7 g/dL for the rest of patients in absence of active bleeding.
15819773|NCT04286958|Drug|Camrelizumab|Camrelizumab: 200 mg was given intravenously over a period of 30 minutes (no less than 20 minutes and no longer than 60 minutes)
15819774|NCT04286945|Procedure|LATERAL RECTUS MUSCLE AUGMENTED RECESSION BY ELONGATION OF THE TENDON WITH AUTOGRAFT FROM RESECTED MEDIAL RECTUS MUSCLE|After resection of the medial rectus muscle, the resected segment is sutured to the lateral rectus muscle after dissection and marking to elongate and slaken the muscle then the elongated muscle is sutured to the sclera at the desired amount of conventional recession.
15819775|NCT04286919|Behavioral|A Randomized Controlled Trial Comparing the Physical Activity Guidelines for Americans to a New Method of Exercise Prescription Among College Students|A randomized controlled trial comparing the 2018 Physical Activity Guidelines for Americans weekly recommendations of 150-minutes of moderate intensity physical activity plus 2 days of muscle-strengthening physical activity to the Move Your Way Campaign message of increasing any and all physical activity to accumulate more movement throughout the week across all types and intensities.
15819776|NCT04286906|Other|Questionnaire|MultiDimensional Profile (MDP), Anxiety-Depression Hospital Scale (HADs), Nijmegen
15819777|NCT04286893|Diagnostic Test|Flow mediated vasodilatation|Measurement of brachial artery diameter change before and after limb ischaemia.
15819778|NCT04286893|Diagnostic Test|High resolution ECG|Measurement HRV using high resolution ECG
15819779|NCT04286893|Diagnostic Test|Blood withdrawal|Measurement of endothelial inflammation markers
15819780|NCT04286880|Procedure|PRP injection|"Clinically proven cases of Trigger points in masseter muscle will be randomly and equally divided into test group and control group. The selected subjects will be divided into two groups.
~Test group will be administered 0.5 ml of PRP solution per trigger point in masseter muscle according to symptoms of patient at baseline (0 week). PRP will be prepared as per methodology mentioned by Okuda et al 2003."
15819781|NCT04286880|Procedure|Dry needling|In control group all the armamentarium and procedure will remain same except that no PRP solution will be delivered. Only dry needling will be performed on the baseline.
15819782|NCT04286867|Other|Alcohol Moderation Mobile Application|This group will receive a link and in-person instructions on how to use the alcohol moderation application described. Individuals in this group will define their drinking limits within the application. The application will provide time points to aid the individual in maintaining their predefined drinking limits throughout the course of the drinking occasion. This group will also receive training on the strategies for alcohol moderation recommended by NIAAA.
15819783|NCT04286867|Behavioral|Alcohol Moderation Drink Tracker|This group will receive the NIAAA tracking card and in-person instructions on how to use the drink tracker card (described at https://www.rethinkingdrinking.niaaa.nih.gov/Thinking-about-a-change/Strategies-for-cutting-down/Tips-To-Try.aspx). Individuals in this group will define their drinking limits, and record their alcohol consumption on the drink tracking card. This group will also receive training on the strategies for alcohol moderation recommended by NIAAA.
15819784|NCT04286854|Diagnostic Test|Stress echocardiography with semi-supine bicycle|"The patient is accelerating against a workload that gradually increases at a constant rate, during the exercise the images will be obtained by echocardiography.
~The patient begins with 25 Watts with increments of 25 Watts every 3 minutes, continuing the exercise until significant electrocardiographic changes occur or the patient starts with symptoms."
15819785|NCT04286841|Drug|Immunotherapy|Patients in this group should be histologically confirmed potentially resectable NSCLC with stage II-IIIA. Furthermore patients would receive either single agent immunotherapy or immunotherapy combined with chemotherapy.
15819786|NCT04286828|Other|Position Sense|Knee position sense was evaluated with a Acumar dual digital inclinometer. Each participant was asked to wear shorts and to lie down in supine position treatment table. The lower extremity of the participant was positioned in neutral for the knee flexion movement. The placement of the digital inclinometer's attachment was the lateral ridge of the femur and tibia. We actively assisted the participant's knee to the target angle and asked the participant to hold it there for 5 seconds before returning the knee to the starting position. After returning to the starting position, participants attempted to repeat the previously attained angle. Participants indicated verbally when they felt they had reached the angle and held their position. This procedure was repeated 3 times for each limb (non-dominant and dominant). We measured the absolute difference between the target angle and the observed angle and calculated the absolute error score by averaging the 3 trials.
15819787|NCT04286828|Other|Balance|"To measure postural stability and Limits of Stability this study used a balance device, the Biodex Balance System.
~Postural Stability: The participants were focused on a characteristic dot (COP, centre of pressure) on the monitor screen. The participant's task was to balance the body in such a way that the dot was in the centre of a circle displayed on the monitor at the point of intersection of the coordinate axes. Test consisted of three 20-second trials, each separated by 10-second breaks. Measurements were repeated three times while their eyes were open/close and analyzed by calculating the average value of measurements.
~Limits of Stability: The participants are asked to complete the directional tasks displayed on a screen as quickly as possible, with the directions displayed at random. A total of 3 tests were performed, at intervals of 10 s."
15819788|NCT04286828|Other|Dual Task Performance|"The timed up and go test (TUG) was used in the evaluation of dual task performance. For this test, participants were seated on a standard armless chair and a cone was placed 3 meters away from the chair. Participants were instructed to stand up and (1) walk towards the cone, (2) turn around the cone, (3) walk back to the chair, and (4) sit back on the chair. It was stated that patients should walk without running but as fast as possible. TUG test was performed initially without task, and then with cognitive and motor tasks, respectively. Cognitive task given during the test is counting three backwards from 100 or counting the names starting with the letter A, and motor task given is to carry three glasses of water on a tray. The time elapses between standing up from the chair and sitting back to chair was recorded as the test result. As time increases, dual task performance decreases."
15819789|NCT04286815|Device|Lentiviral Vector Gene Therapy|Lentiviral vector to transfer IL2RG complementary DNA to patients'bone marrow stem cells
15819790|NCT04286802|Device|Salt-meter|Salt-meter, developed by Faculty of Engineering at Mahidol University, is a device to measure sodium chloride content in the food and reflects to user with number and symbols for easy-understanding.
15819791|NCT04286802|Behavioral|Education|Program dietary education by certified dietician who did not know the patients arm allocation.
15820147|NCT04283643|Other|Transcranial Focused Ultrasound|Non-invasive brain stimulation technique
15819796|NCT04286776|Other|Direct electrical stimulation|Stimulation lasting from 500 to 2000 milliseconds on bipolar target electrode pairs at one of two target frequencies (e.g. 10 Hz and 200 Hz), up to 1.5 milliamperes in amplitude on depth contacts and 3.5 milliamperes in amplitude on surface contacts. (Pulse shape - Charge-balanced biphasic rectangular pulses with pulse width of 300 microseconds in duration per phase).
15819797|NCT04286763|Diagnostic Test|Biliary RMI and CT scan.|"For a good appreciation of the anatomy of the biliary lesion, an MRI was systematically performed on all our patients.
~For a good appreciation of the presence of an associated vascular lesion, a CT-scan was systematically performed on all our patients."
15819798|NCT04286750|Drug|ACT-1004-1239|ACT-1004-1239 administered as hard capsules for oral use.
15819799|NCT04286750|Drug|Placebo|Matching placebo administered as hard capsules for oral use.
15819800|NCT04286737|Other|Therapeutic Touch|Therapeutic Touch will be applied to infants for 3 consecutive days, once a day, 10 minutes at any time during the day. There will be a four-day break. The Therapeutic Touch will be done a total of 6 times in 2 weeks.
15819801|NCT04286724|Behavioral|"Brief behavioural procedure including a computerized visuospatial task (computer game Tetris)"|"Brief behavioural procedure including a computerized visuospatial task (the computer game Tetris) preceded by a reactivation of the traumatic memory of childbirth"
15819802|NCT04286711|Drug|Albumin-paclitaxel, Apatinib, Camrelizumab|Albumin-paclitaxel: ivgtt, 75 or 100 or 125mg /m2, d1, d8, Repeat the therapeutic schedule every 3 weeks; Apatinib: initial dose: 250mg,oral,once a day, after meal ( try to take the medicine at the same time each day); Camrelizumab：ivgtt, 200mg, given on the first day, Q3W;
15819803|NCT04286698|Other|Complex decongestive physiotherapy|MLD was administered 5 days a week for 4 weeks, with each session lasting 30 minutes [25]. Compression therapy was applied to the patients by wearing a compression mask (FM Velcro Fastener, LIPOELASTIC), made of polyamide, cotton, viscose, and elastane, that covered the submandibular region, the masseter region, and the neck. The compression mask is specifically designed for the healing and recovery of tissues after plastic and aesthetic surgeries. The patients were advised to wear the compression masks for at least 4-6 hours per day for 4 weeks and gradually increase wearing time according to their tolerance. The patients were asked to perform skin care by themselves. Skin care was applied using a low pH skin lotion to moisturize the skin. Neck, face/mimic, tongue, and posture exercises were performed by patients while the compression mask was worn and under the supervision of a physiotherapist, with 10 repetitions 5 times a week for 4 weeks.
15819804|NCT04286698|Other|Home program|Self-MLD and exercises (neck, face/mimic, tongue, and posture exercises) were shown to the patients in this group. Self-MLD included self-administered lymph drainage of the axillary, posterior, lateral, and anterior neck areas; the pre- and retro-auricular regions; the lateral and anterior regions of the face; and the lower jaw region. Then the order is reversed back to the starting point [3]. A video of self-MLD and a text including exercise descriptions were shared with patients and their relatives to ensure that the self-MLD and exercises were performed accurately and regularly at home. Self-MLD was recommended to be applied once a day, and the exercises were advised to be performed for 10 repetitions each, 10 times a day for 4 weeks. The patients were called by phone during the second week after their first evaluation as a control and to motivate the patient for performing self-MLD and home exercises properly.
15819805|NCT04286672|Diagnostic Test|Metadherin|study alterations of MTDH gene expression in the serum of bladder cancer patients
15819806|NCT04286620|Device|LASIK|Correcting errors of refraction
15819807|NCT04286607|Drug|Topical roflumilast|Active treatment
15819808|NCT04286594|Drug|CBD|Participants will be randomized to receive CBD or placebo solution during the double-blind phase of the trial.
15819809|NCT04286594|Drug|Placebo|Participants will be randomized to receive CBD or placebo solution during the double-blind phase of the trial.
15819810|NCT04286581|Device|I-Gel Laryngeal Mask Airway|The I-Gel Laryngeal Mask Airway is a medical device that keeps a patient's airway open during anaesthesia or unconsciousness.
15819811|NCT04286581|Device|Ambu Auragain Laryngeal Mask Airway|The Ambu Auragain Laryngeal Mask Airway is a medical device that keeps a patient's airway open during anaesthesia or unconsciousness.
15819812|NCT04286568|Behavioral|WOW Intervention|Health education and coaching, health care navigation,
15819813|NCT04286555|Other|DASH4D diet|"DASH stands for Dietary Approaches to Stop Hypertension. The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate."
15819814|NCT04286555|Other|comparison diet|The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium).
15819815|NCT04286555|Other|higher sodium|3700 mg/day sodium
15819816|NCT04286555|Other|lower sodium|1500 mg/day sodium
15819817|NCT04286542|Diagnostic Test|Cold, dry air|Participants will be exposed to cold (<-10°C, <10% relative humidity), dry air for 15 minutes.
15819820|NCT04286516|Device|Transcranial Magnetic Stimulation|Paired pulse transcranial magnetic stimulation
15819821|NCT04286503|Drug|Carrimycin|Carrimycin
15819822|NCT04286503|Drug|lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate|lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate
15819823|NCT04286503|Drug|basic treatment|basic treatment
15819824|NCT04286490|Other|Prone position|Abdomen suspension in prone position
15819825|NCT04286464|Other|No intervention|No intervention
15819826|NCT04286451|Behavioral|Sleep Restriction|Women will be undergo 4 nights of sleep restriction.
15819827|NCT04286451|Behavioral|Habitual Sleep|Women will be undergo 4 nights of habitual sleep.
15819950|NCT04285476|Diagnostic Test|Signature of 10 microRNA for patients with bethesda classification 3, 4 or 5|If the cytology results are Bethesda 3, 4 or 5, then a miRNA analysis will be performed.
15819828|NCT04286438|Drug|Bentracimab (PB2452) Infusion|"Bentracimab (PB2452) 18 g Intravenous Infusion over a 16 hour duration.
~In subjects with potential drug interaction from recent concomitant use of moderate or strong CYP3A inhibitors with ticagrelor, the active treatment period may be 24 hours and 10 min if receiving the 36g infusion"
15819829|NCT04286425|Other|seminal plasma|Seminal plasma free of sperm, from donor men with normal sperm parameters, and tested for HIV1, HIV2, Hepatitis B, Hepatitis C, Syphilis, Chlamydia and Gonorrhea on blood and urine
15819830|NCT04286425|Other|saline solution|saline solution
15819831|NCT04286412|Biological|Nonacog alfa|Nonacog alfa is indicated in India for the treatment and prophylaxis of bleeding in patients with hemophilia B (congenital factor IX deficiency).
15819832|NCT04286399|Drug|Renin-angiotensin-aldosterone system inhibitors|Research participants in the intensive therapy arm should be strongly encouraged to follow the intensive treatment strategy. Every attempt should be made to up-titrate RAS-antagonists and beta-blockers (max dosage, unless contraindicated) as well as preferentially use SGLT2i (standard dosage, as required) throughout the trial.
15819833|NCT04286399|Drug|Beta blocker|Research participants in the intensive therapy arm should be strongly encouraged to follow the intensive treatment strategy. Every attempt should be made to up-titrate RAS-antagonists and beta-blockers (max dosage, unless contraindicated) as well as preferentially use SGLT2i (standard dosage, as required) throughout the trial.
15819834|NCT04286399|Drug|SGLT2 Inhibitor - Sodium Glucose Cotransporter Subtype 2 Inhibitor Product|Research participants in the intensive therapy arm should be strongly encouraged to follow the intensive treatment strategy. Every attempt should be made to up-titrate RAS-antagonists and beta-blockers (max dosage, unless contraindicated) as well as preferentially use SGLT2i (standard dosage, as required) throughout the trial.
15819835|NCT04286386|Other|Hyperpolarized Carbon C 13 Pyruvate|Given IV
15819836|NCT04286386|Procedure|Magnetic Resonance Spectroscopic Imaging|Undergo MRSI
15819837|NCT04286386|Procedure|Surgical Procedure|Undergo standard of care surgery
15819838|NCT04286373|Device|active stimulation then placebo stimulation|"The active VNS stimulation will be applied in the hollow of the left outer ear on the auricular branch of the vagus nerve (cymba conchae), a session of 1 hour of stimulation per week, at a weak intensity value (between 2 to 5 mA), depending on the tolerance of each patient.
~VNS placebo stimulation will be performed under the same conditions and parameters as active VNS stimulation, but at a different site: the left ear lobule according to previously published methods (Fang et al. 2017, Frangos et al. 2015).
~The two stimulation periods will be separated by a 4 weeks wash-out period."
15819839|NCT04286373|Device|placebo stimulation then active stimulation|"The active VNS stimulation will be applied in the hollow of the left outer ear on the auricular branch of the vagus nerve (cymba conchae), a session of 1 hour of stimulation per week, at a weak intensity value (between 2 to 5 mA), depending on the tolerance of each patient.
~VNS placebo stimulation will be performed under the same conditions and parameters as active VNS stimulation, but at a different site: the left ear lobule according to previously published methods (Fang et al. 2017, Frangos et al. 2015).
~The two stimulation periods will be separated by a 4 weeks wash-out period."
15819840|NCT04286347|Procedure|HCV, HBV, HIV tests|HCV, HBV, HIV testing during consultation with Anesthesiologist before a planned surgery
15819841|NCT04286334|Device|Bone augmentation with cad-cam laser-sintered mesh|Titanium meshes cad cam laser-sintered were applied in sites with alveolar bone deficiency in order to regenerate the bone volume in need of implant-prosthetic restorations.
15819842|NCT04286321|Other|Zero hard-boiled egg|No eggs will be consumed on test day
15819843|NCT04286321|Other|Two egg whites|Two egg whites will be consumed on test day
15819844|NCT04286321|Other|Two hard-boiled eggs|Two eggs will be consumed on test day
15819845|NCT04286321|Other|Vegetable oil|Vegetable oil will be consumed on test day
15819846|NCT04286308|Other|electrophysiological data collection|Electrophysiological data collection at the time of DBS surgery.
15819847|NCT04286295|Drug|Cytisine|Cytisine is a plant-based smoking cessation medication. Cytisine acts by reducing the rewarding effect of nicotine and attenuating nicotine withdrawal symptoms. A recent review concluded that cytisine is the most promising future smoking cessation treatment. Cytisine is inexpensive to produce and is currently priced much lower than other cessation medications. It is well-tolerated by smokers and requires a shorter treatment period than conventional treatments. Because it is plant-based, cytisine may be attractive for smokers who prefer 'natural' medicines. Numerous placebo-controlled studies have demonstrated the safety and efficacy of cytisine. One high-quality pragmatic non-inferiority trial (n = 1310) found that cytisine was superior to nicotine replacement therapy (NRT) in improving self-reported continuous abstinence rates at 1 week, and 1, 2 and 6 months when both groups received minimal behavioural support.
15819848|NCT04286295|Drug|Nicoderm C-Q Transdermal Product|The Nicoderm® patch plus Nicorette® Lozenge will be provided to participants in the combination NRT group. Participants will be instructed to apply a new patch each day. They will continue to wear patches for 25 days.
15819849|NCT04286295|Drug|Nicorette Lozenge Product|Participants in the NRT group will receive Nicorette Lozenges to use during their 25-day quit attempt. They will receive enough lozenges to last for the 25-day treatment period.
15819850|NCT04286282|Behavioral|Group Pyschotherapy|Group psychotherapy
15819851|NCT04286282|Other|Depression Standard of Care|Standard clinical care for depression, which may include the use of selective serotonin re-uptake inhibitors (SSRIs).
15819852|NCT04286282|Other|HIV Standard of Care|Standard clinical care for HIV
15819853|NCT04286269|Other|Music Based Intervention|Participants assigned to MBI will receive a total of 1.5 hours of music intervention 5-6 sessions per week. Music will be alternating: 30 minutes on and 30 minutes off and will be played when the subject is awake to cue pacification and initiate the sleep process. Music will be delivered through headphones using an MP3 player.
15819854|NCT04286269|Other|Sham Treatment|Participants assigned to the control group will have the same treatment as the MBI group, but with no sound played through the headphones.
15819855|NCT04286256|Behavioral|Motivational Interviewing|Participants/caregivers will receive several telephone-based and in-person motivational interviewing sessions along with specific oral health recommendations.
15819856|NCT04286243|Other|Community-based HPV screening strategy|Offering HPV self-collection for cervical cancer screening in the community
15819857|NCT04286243|Other|Clinic-based HPV screening strategy|Offering HPV self-collection for cervical cancer screening in the clinic
15819858|NCT04286230|Behavioral|Adherence to oral antibiotics assessed by Questionnaire|The purpose of the BIOTICA-questionnaire is to detect individual barriers preventing the optimal intake of oral antibiotics and thus, leading to inadequate adherence or persistence to the regimen.
15819859|NCT04286230|Behavioral|Persistence to oral antibiotics assessed by Questionnaire|The purpose of the BIOTICA-questionnaire is to detect individual barriers preventing the optimal intake of oral antibiotics and thus, leading to inadequate adherence or persistence to the regimen.
15819860|NCT04286204|Other|Basic Life Support training based on ICTs|This intervention is defined as a self-training course consisting of a 5-minute educational video in basic life support and a Kit with the elements to build the home dummy and the home DEA allowing integrally students to develop the steps as the video. The Kit will be delivered at the beginning of the study and every month the necessary materials will be complemented. The strategy will be carried out by the students every month and supervised by their teachers. Students will have constant access to an educational platform based on ICTs.
15819861|NCT04286204|Other|Classic Basic Life Support training|It is defined as a module carried out by trained personnel in basic resuscitation (pre-hospital care program staff of the UdeA medical school), which includes two subcomponents of the conventional BLS course that are basic resuscitation and DEA in adults. The duration of the subcomponents is a theoretical part of 30 minutes and a practical part in a low fidelity simulator with 1.5 hours duration.
15819864|NCT04286178|Dietary Supplement|creatine monohydrate|Creatine will be taken at a dose of 150mg/kg/day of creatine base divided into 2 daily doses up to 39.7kg in body weight, after which dosing will be based on body surface area (BSA) at 4.69g/m2/day. Creatine will be administered orally as a chewable tablet provided by BioTechUSA™. Tablets are 2g and contain 0.9g of creatine monohydrate which is equivalent to 0.8g of creatine base.
15819865|NCT04286178|Dietary Supplement|ubiquinol|Coenzyme Q10 (CoQ10, ubiquinol) will be taken at a dose of 10mg/kg/day divided into 2 daily doses with a daily maximum of 500mg. CoQ10 will be administered orally in 50mg softgels containing 50mg of ubiquinol (Active Q®), provided by Tishcon Corporation.
15819866|NCT04286178|Dietary Supplement|glucose tablet|Creatine placebo will be in the form of a glucose tablet with identical appearance and taste to the active supplement. The number of tablets/day will be determined based on the dose of creatine required for each patient.
15819867|NCT04286178|Dietary Supplement|gel capsule|Ubiquinol placebo will be in the form of a gel capsule with identical appearance to the active supplement. The number of capsules/day will be determined based on the dose of ubiquinol required for each patient.
15819868|NCT04286178|Behavioral|Exercise|"Participants will be coached to hit 12,000 steps or 60 active minutes per day as logged by a FitBit (FitBit calculates active minutes as activities equivalent to moderate-to-vigorous physical activity (MVPA) done continuously for at least 10 minutes)"
15819869|NCT04286165|Other|Brief Peer Supported webSTAIR|The BPS webSTAIR program is an online platform where individuals are taught skills in emotion regulation. In this program they will learn how to recognize the emotions they are feeling by assessing their own body language, being attentive to their thought processes, and attempting to replace negative behaviors with positive. Throughout the platform they will engage in written exercises to help them solidify the lessons with their own life experiencing. They will also have the support of peers throughout the program to help them when they need clarification or having a difficult time applying the lesson(s).
15819870|NCT04286152|Drug|Mirabegron 50 MG|The experimental drug is administered to patients PO once a day for 7 days from stent insertion until removal
15819871|NCT04286152|Drug|Placebo oral tablet|A sugar pill manufactured to mimic Mirabegron 50 mg tablet is administered to patients PO once a day for 7 days from stent insertion until removal
15819873|NCT04286126|Device|Active bilateral DMPFC|Participants in this arm will receive rTMS to bilateral DMPFC. The DMPFC will be targeted utilizing either Nexstim's eField neuronavigation system or Localite's neuronavigation system. Stimulation intensity will be standardized at 90% of resting motor threshold (RMT) and adjusted to the skull to cortical surface distance (see Nahas 2004).
15819874|NCT04286126|Device|Active right-sided OFC|Participants in this arm will receive rTMS to the right OFC. The right OFC will be targeted utilizing either Nexstim's eField neuronavigation system or Localite's neuronavigation system. Stimulation intensity will be standardized at 90% of resting motor threshold (RMT) and adjusted to the skull to cortical surface distance (see Nahas 2004).
15819875|NCT04286113|Behavioral|control group|will receive standard medical care where research assistant will give pamphlets, with one size fits all recommendations for diet/nutrition, physical activity and sleep, to 10 subjects with comorbid HTN and T2D.
15819876|NCT04286113|Behavioral|Lifestyle management|Will use passive ubiquitous sensing through FitBit to 1)learn behavioral profiles of subjects who have pre-HTN/HTN and/or pre-diabetes /Diabetes 2) provide personalized recommendations through mobile based messaging app that will increase the likelihood of engaging in health diet/nutrition, physical activity and sleep practices
15820148|NCT04283643|Other|Transcranial Magnetic Stimulation|Non-invasive brain stimulation technique
15819877|NCT04286087|Procedure|neck incisions closed at bedside at the time of drain removal under local anesthesia|Participants allocated to the investigational group will have neck incisions closed at bedside at the time of drain removal under local anesthesia
15819878|NCT04286087|Procedure|standard treatment|Participants in the control group will have standard treatment performed as per current practice,their incision will be left to close by secondary intention
15819879|NCT04286074|Other|50% resistance|Prior to training, the muscle training technique will be performed. The objective of applying the intervention using the Powerbreathe® device is to produce an increase in inspiratory force. The technique will be performed with the athlete standing, holding the device with his hand and his lips sealed on the mouthpiece. After a full expiration, you will make a quick and deep inspiration. The principal investigator of the study will ensure that the technique is performed correctly. There will be 2 series of 30 maximum inspirations. These interventions will be faced with a resistance of 50% of the maximum inspiratory pressure of each athlete
15819880|NCT04286074|Other|10% resistance|Prior to training, the muscle training technique will be performed. The objective of applying the intervention using the Powerbreathe® device is to produce an increase in inspiratory force. The technique will be performed with the athlete standing, holding the device with his hand and his lips sealed on the mouthpiece. After a full expiration, you will make a quick and deep inspiration. The principal investigator of the study will ensure that the technique is performed correctly. There will be 2 series of 30 maximum inspirations. These interventions will be faced with a resistance of 10% of the maximum inspiratory pressure of each athlete
15819881|NCT04286061|Other|Assisted soft tissue mobilization|It will be done for 60 seconds, making a total of 30 strokes with the tool in the longitudinal direction to the muscle fibers. The physiotherapist will previously apply some massage cream to the area to be treated (adductor musculature) so that the tool slides at a 45º angle. Landslides will be made from the femoral condyle to the groin, and vice versa, exerting a pressure with the instrument of 3 over 10 on the analog visual scale that the subject feels
15819882|NCT04286048|Other|Weight implement|"The technique will be done by making the same movement of the launch, but with the weight implement. The physiotherapist will be next to the pitcher, noting that there is no pain or discomfort when launching. The session will be held for 15min with 30 seconds of rest between each launch, until reaching 15 pitches.
~The sessions will be directed by a physiotherapist, in charge of supervising that the pitcher is correctly making the requested movement."
15819883|NCT04286035|Drug|Bupivacaine Injection|Femoral nerve block with 20 ml %0.375 bupivacaine
15819884|NCT04286035|Drug|Bupivacaine Injection|Adductor canal block with 20 ml %0.375 bupivacaine
15819885|NCT04286022|Other|Speed Loss 20% Strength Training|Strength training based on the control of speed loss in execution.
15819886|NCT04286022|Other|Reduced Rest Time Strength Training|Strength training based on a protocol that includes reduced rest times between sets.
15819887|NCT04285996|Procedure|PET Scan|
15819889|NCT04285970|Other|cycle detection|6-minute test on a treadmill at pedestrian speed (5km/h) with 2 instruments (dynamometric wheel and inertial centre) on a standardised wheelchair
15819890|NCT04285970|Other|detection of effort intensity|6-minute test on an urban course with 2 instruments (dynamometric wheel and inertial units) on a wheelchair
15819891|NCT04285957|Other|Questionnaire administration pre test|"Pre-test:
~Two expert physicians/physical therapist shall be involved in the questionnaire administration (A/B). The questionnaires shall be randomly administered to the patients by one operator at T0 the same test shall be readministered after 1-2 weeks by another operator (T1), blind to the first assessment; the second operator shall also administer the additional measures (SIP and RMI);"
15819892|NCT04285957|Other|Questionnaire administration - validation|Validation Two expert physicians shall be involved in the questionnaire administration (A/B). The questionnaires shall be randomly administered to the patients by one operator at T0 the same test shall be readministered after 1-2 weeks by another operator (T1), blind to the first assessment; the second operator shall also administer the additional measures (SIP and RMI); In case the patient is unable to be interviewed due to aphasia cognitive or sensorial problems, a proxy would be interviewed both at T0 and at T1 (the same proxy would be interviewed both times)
15819893|NCT04285944|Other|Mavig X-ray Protective Drapes|Mavig X-ray Protective Drapes®
15819894|NCT04285918|Procedure|Percutaneous device closure|If there is no relevant AF detected for 6 months during intermittent follow-up or ICM, device closure of PFO is recommended for high-risk PFOs but is decided ultimately at the discretion of the attending physician. If there is any relevant AF identified from ICM or other modalities during follow-up, adequate secondary prevention with anticoagulants should be carried out. All this process and decision making should be a part of routine clinical practice.
15819895|NCT04285905|Other|Access to Fast Track TB clinic|Male partner can attend clinic with dedicated services for men
15819896|NCT04285905|Other|Information leaflet for male partner|Female participants will be provided with a letter asking their male partner to attend the clinic for tuberculosis screening
15819897|NCT04285905|Other|Home sputum collection|Female participants will be provided with sputum cups to take home and collect a sample of sputum from their male partner
15819898|NCT04285905|Other|Home HIV testing|Female participants will be provided with an oral HIV self-test kit to be given to their male partner with instructions for use
15819899|NCT04285905|Other|Financial incentive|Female participants will be provided with a voucher for MKW5000 which can be redeemed when the male partner attends the clinic for TB testing
15819900|NCT04285892|Device|CAPA-IVM|"CAPA medium keeps oocytes in meiotic arrest for 22-24 hours. IVM medium allows oocytes to resume meiosis.
~CAPA medium: 10% human serum albumin (HSA) + 10nM estradiol (E2) + 25nM CNP + 5ng/ml Insulin + 1mIU/ml follicle stimulating hormone (FSH) IVM medium: 10% HSA + 10nM E2 + 5ng/ml Insulin + 101mIU/ml FSH + 100ng/ml AREG CNP: peptide naturally occurring in follicles to maintain meiotic arrest, E2: estrogen, enhances effects of CNP, Insulin: basic growth factor used in cell cultures and component of commercially available LAG medium of the standard IVM system, AREG: downstream effector of the LHCG receptor which helps meiotic resumption. HSA, FSH and hCG are CE labeled. CAPA IVM medium is currently not yet available as CE marked commercially available medium and needs to be prepared in house."
15820149|NCT04283630|Dietary Supplement|Dietary nitrate in the form of beetroot juice for all participnats|participants asked to consume dietary nitrate in the form of beet juice everyday in the morning and then one hour later, the vitamin C capsules.
15819901|NCT04285879|Device|Blood Flow Restriction using Delfi Personalized Tourniquet System|The Delfi Tourniquet System is designed to be used in conjunction with exercise. The system automatically determines the degree of occlusion and allows for safe regulation of pressure. Patients will then complete exercises with the use of this device following the Owens Recovery Science Protocol
15819902|NCT04285866|Drug|Durvalumab|Durvalumab after chemoradiotherapy
15819903|NCT04285853|Drug|Oxycodone|5 mg oxycodone pills every 4-6 hrs if pain level 7 or higher on Numeric rating scale 1-10
15819904|NCT04285853|Drug|Placebo oral tablet|"Placebo tablets (both trial and rescue) will be matched to size, shape, color, and texture of oxycodone tablets."
15819905|NCT04285840|Other|Venous ACT|Matched/paired venous ACT samples will be drawn at the same time as arterial ACT samples to compare the results agreement between venous and arterial ACTs. Subjects undergoing atrial fibrillation ablations will continue to have Heparin dosed on the arterial ACT sample results only per the standard of care. Heparin will not be administered based on venous ACT levels obtained during this study.
15819906|NCT04285827|Biological|CSL889|Administered as an IV infusion
15819907|NCT04285814|Diagnostic Test|Whole Fetal Cell (WFC) Testing|Performing WFC testing on blood specimens.
15819908|NCT04285775|Device|Application of device which monitors for bleeding - Blood Warning Technology with Continuous Hemoglobin sensor (BWATCH)|A stand-alone disc-shaped device (approximately 5 cm in diameter and <1 cm thick) which can be placed over dressings. Once switched on and put in place, continuous monitoring for bleeding takes place. Detection occurs in 2 phases. First, the system monitors for the appearance of fluid in the dressing by detecting a change in capacitance. Next, a light sensor differentiates blood from other fluids by detecting that a unique spectrum of light (525nm) is absorbed, a property unique for hemoglobin. The presence of fresh blood triggers a loud alarm, alerting medical staff to attend to the patient. The device can be used over transparent plastic dressings and does not require direct contact with blood.
15819909|NCT04285762|Other|LVEEA|lymphaticovenous end-to-end
15819910|NCT04285762|Other|LVESA|lymphaticovenous end-to-side
15819911|NCT04285762|Other|LVSEA|lymphaticovenous side-to-end
15819912|NCT04285749|Drug|Fluvastatin|Fluvastatin PO 80mg QD for 2 weeks
15819913|NCT04285749|Other|RNA-sequencing|RNA-sequencing will be completed on the original diagnostic biopsy and the final melanoma excision
15819914|NCT04285749|Other|Gene expression profiling|Gene expression profiling will be completed on the original diagnostic biopsy and the final melanoma excision
15819915|NCT04285736|Drug|Ivabradine|Ivabradine (5mg twice daily)
15819916|NCT04285736|Drug|Conventional Treatment|
15819917|NCT04285710|Device|Phototherapy|The key intervention aspect of this study is the application of 15 J/cm2 of 410 nm pulsed light directly onto the infected diabetic wounds of subjects every week over the course of 3 months, allowing for the cumulative exposure of around 180 J/cm2 for the entire study. This 15 J/cm2 weekly dosage of blue light will split up into two sessions every week, with each session applying 7.5 J/cm2 of light treatment. Phototherapy will be applied twice per week, with one phototherapy session occurring directly following the debridement surgery during the first visit of the week and the other session occurring after the study clinician removes the subjects wound dressings at the second visit.
15819918|NCT04285710|Procedure|Debridement Surgery and Wound Dressing|All patients enrolled in the study will undergo standard care and treatment for infected diabetic wounds, which includes the weekly surgical removal of infected necrotic tissue from the diabetic wounds. In addition to debridement, both groups will utilize an antimicrobial wound dressing to cover and treat the infected diabetic wound. The subject's wounds will be dressed with Aquacel Ag Advantage Wound Dressings to protect and treat their diabetic wounds. These dressings will be changed twice a week by clinicians.
15819919|NCT04285697|Other|infection prevention bundle|"The infection prevention bundle (IPB) implemented items:
~Preoperative counseling and questionnaire: patient counseling and preparation instructions, screening questions for signs of infection, and presence of open or nonhealing wounds.
~Nasal methicillin-resistant and methicillin-sensitive Staphylococcus aureus decolonization: preoperative 24 hours ago twice-daily application of 2% mupirocin ointment to bilateral nares with final application on the morning of surgery.
~Body decolonization: Cleansing with 4% chlorhexidine gluconate shower the evening before surgery and the morning of surgery.
~Preoperative weight-based antibiotics within 60 minutes of incision
~Strict draping and surgical techniques the standardization Irrigation of the surgical site with warm Isotonic NaCl solution before skin closure Postoperative wound care education to patient and family"
15819920|NCT04285684|Drug|ketamine in lactation|2 dose IM by weight and assessing concentrations of ketamine in expressed milk at intervals
15819921|NCT04285671|Biological|Necitumumab|Given IV
15819922|NCT04285671|Drug|Osimertinib|Given PO
15819923|NCT04285671|Other|Quality-of-Life Assessment|Ancillary studies
15819924|NCT04285671|Other|Questionnaire Administration|Ancillary studies
15819925|NCT04285671|Biological|Trastuzumab|Given IV
15819926|NCT04285658|Procedure|Ureteroscopy|An outpatient endoscopic surgery that accesses the ureters and kidneys per the urethra to fragment and remove the stones. Many patients who undergo ureteroscopy (URS), Shockwave lithotripsy (SWL), or percutaneous nephrolithotomy (PCNL) also have temporary tubes placed after the surgery to facilitate drainage, either internally (a stent) or externally (a nephrostomy tube).
15819927|NCT04285658|Procedure|Percutaneous Nephrolithotomy|A minimally invasive surgery in which a ~1cm flank incision is made, and a scope is passed through a tubular sheath into the kidney to fragment and remove the stone. There is typically a 1- to 2-day hospital stay. Many patients who undergo URS, SWL, or PCNL also have temporary tubes placed after the surgery to facilitate drainage, either internally (a stent) or externally (a nephrostomy tube).
15819928|NCT04285658|Procedure|Shock Wave Lithotripsy|A non-invasive outpatient procedure that targets stones in the kidney or ureter with x-ray or ultrasound and uses shockwaves generated outside the body to fragment them; the fragments pass down the ureter and the patient expels them in the urine. Many patients who undergo URS, SWL, or PCNL also have temporary tubes placed after the surgery to facilitate drainage, either internally (a stent) or externally (a nephrostomy tube).
15820037|NCT04284618|Diagnostic Test|assessment of standardized and off axis view radiographs|Radiographic assessment of hallux valgus interphalangeus angles is performed on preoperative standing anteroposterior and on off axis view radiographs. These radiographs are taken by equalizing the hyperpronation of the greater toe.
15819929|NCT04285645|Other|Warmup|The intervention through exercises will consist in the application of the protocol described by Waldén et al. The objective of the application of this exercise protocol is to produce an improvement in the stability of the knee and the strength of the quadriceps. Before carrying out the exercises, a continuous race will be carried out for 5 minutes, once this first step is finished we will proceed to the realization of the exercises that will be, squats with both legs placing the hands on the hips, feet placed at the width of the shoulders, lowering with a straight back and without raising the heels of the floor, 3 series of 15 repetitions, squats on one leg with the hands on the hips and leg not supported extended forward, 3 sets of 10 repetitions with each leg and jump forward with one leg with the hands on the hips and jump back to return to the starting position, 3 sets of 10 repetitions with each leg
15819930|NCT04285632|Other|Plyometrics exercises|"Counter Movement Jump exercise. The subject will be placed in an upright standing position, with his hands on his hip. It will perform a rapid downward movement in which it will flex the hips and knees and, immediately, a rapid extension of the legs that will result in the maximum vertical jump. During the flight phase the subject will keep the legs straight. The landing will be done with both feet at the same time. The intervention will be carried out for 300 seconds, in 2 series of 30 jumps each and with 3 minutes of rest between series.
~Drop Jump exercise. The players will be placed on a step, standing and with their feet shoulder-width apart. They will drop forward, landing with both feet at the same time. Upon touching the ground they will perform a maximum vertical jump. The intervention will be carried out for 600 seconds, in 2 series of 25 jumps each, and with 3 minutes of rest between series."
15819931|NCT04285619|Other|Positive expectation|"After heating, the physiotherapist will apply the bandage with flossing on both ankles, using 2 Voodoo Floss Bands (Power Guidance model). The distal to proximal bandage will begin with a tension of 50-70% and each lap of the bandage will cover 50% of the previous lap. There will be 3 figures of 8 that will cover the hindfoot and the distal third of the leg.
~With the bandage applied on both feet, the runners will perform plantar flexion and active dorsal flexion movements in a range of complete joint movement with both ankles, at a constant rate of 2 seconds of plantar flexion, followed by another 2 of dorsal flexion, during A period of 2 minutes. Next, the therapist will remove the bandages and the athlete will walk barefoot for a minute, to restore normal blood flow.
~During the first application of the bandage, the investigator will induce the positive expectation through a standardized phrase for all subjects"
15819932|NCT04285619|Other|Neutral expectation|"After heating, the physiotherapist will apply the bandage with flossing on both ankles, using 2 Voodoo Floss Bands (Power Guidance model). The distal to proximal bandage will begin with a tension of 50-70% and each lap of the bandage will cover 50% of the previous lap. There will be 3 figures of 8 that will cover the hindfoot and the distal third of the leg.
~With the bandage applied on both feet, the runners will perform plantar flexion and active dorsal flexion movements in a range of complete joint movement with both ankles, at a constant rate of 2 seconds of plantar flexion, followed by another 2 of dorsal flexion, during A period of 2 minutes. Next, the therapist will remove the bandages and the athlete will walk barefoot for a minute, to restore normal blood flow.
~During the first application of the bandage, the researcher will not induce any expectations to the athletes."
15819933|NCT04285606|Behavioral|Patient-led rehab with short immobilization|Short immobilization followed by patient-led shoulder rehab
15819934|NCT04285593|Other|Bulgarian squats|The intervention using Bulgarian squat exercises will consist in the application of the protocol described by Aguilera-Castells et al. The technique will be done with the footballer standing. The athlete with one foot in front and the other behind the body, arms crossed over her chest, and her upper body, will remain upright with a natural swing in the lower back during the entire exercise. The players will lower the body (eccentric phase) until the front knee flexes to 90º. Subsequently, they will return to the initial position with a full extension of the knee of the front leg (concentric phase), maintaining an erect trunk position. The front foot will be placed in a fixed position contacting the ground, and the rear foot will rest on a horizontal press bench.
15819935|NCT04285580|Drug|Bimatoprost SR|Consists of 1 Bimatoprost SR administration in the study eye.
15819936|NCT04285580|Drug|LUMIGAN|Treatment with LUMIGAN 0.01% begins on Day 1. The drop will be instilled once daily in the evening to the study eye throughout the duration of the study.
15819937|NCT04285567|Drug|Obinutuzumab|Obinutuzumab 1000 mg will be administered IV on Days 1 (and 2), 8, and 15 of Cycle 1 and on Day 1 of Cycles 2-6.
15819938|NCT04285567|Drug|Venetoclax|Venetoclax 20 mg will be administered orally, once daily starting on Day 22 of Cycle 1 for 7 days, then ramp up from 50 to 400 mg/day during Cycle 2 and continue at 400 mg/day from Day 1 of Cycle 3 till end of Cycle 12.
15819939|NCT04285567|Drug|Fludarabine|Fludarabine will be administered in a dosage of 25 mg/m^2 IV on days 1, 2, and 3 of Cycles 1-6.
15819940|NCT04285567|Drug|Cyclophosphamide|Cyclophosphamide will be administered in a dosage of 250 mg/m^2 IV on Days 1, 2, and 3 Cycles 1-6.
15819941|NCT04285567|Drug|Rituximab|Rituximab will be administered at a dose of 375 mg/m^2 IV on Cycle 1, Day 1 followed by 500 mg/m^2 on Day 1 of Cycles 2-6.
15819942|NCT04285567|Drug|Bendamustine|Bendamustine will be administered at a dose of 90 mg/m^2 IV on 2 consecutive days of Cycles 1-6.
15819943|NCT04285554|Device|iRF System Hepatic Denervation|The iRF System is a percutaneous, catheter-based device which uses RF energy to circumferentially denervate the sympathetic nerves surrounding the common hepatic artery (CHA).
15819944|NCT04285528|Drug|General anesthetia Fentanyl and Propofol|Patients were anesthetized using Fentanyl (2 mcg per kg) and Propofol (1-2 mg per kg). Proper classic laryngeal mask airway was inserted afterwards.
15819945|NCT04285528|Combination Product|PFK|A mixture of 5 mcg/ml of Fentanyl, 5 mg/ml of Propofol, and 5 mg/ml of Ketamine was used. Each patient received an initial dose of 0.5 mg/kg from the solution, then after waiting for 60 seconds, another 0.5 mg/kg were given. Maintenance was given as boluses of 0.2- 0.33 mg/kg every three to five minutes. No Laryngeal mask airway nor endotracheal tube were inserted, and the patients were breathing spontaneously through a simple face mask on a support of 3 L/min O2.
15819946|NCT04285515|Drug|Lumateperone|Lumateperone 42mg oral capsule
15819947|NCT04285515|Drug|Placebos|Placebo oral capsule
15819948|NCT04285502|Procedure|SURGICAL DRAIN|A surgical drain is a tube used to remove blood, abscess and any type of fluid at the site of the place it is inserted
15819949|NCT04285489|Device|Hakim Shunt Programmable System|patient accept Hakim Shunt Programmable System due to HCP
15819951|NCT04285463|Diagnostic Test|Transbronchial Lung Cryobiopsy (TBLC)|TBLC is a relatively new endoscopic technique used to obtain lung parenchyma specimens. It is a minimally invasive technique performed with a flexible or rigid bronchoscope under deep sedation or general anesthesia. Flexible cryoprobes of either 1.9 or 2.4 mm in diameter are introduced into a bronchoscope and a compressed gas, most commonly carbon dioxide or nitrous oxide, is released at high flow at the tip of the probe. As the tissue rapidly freezes, it adheres to the probe and is avulsed and extracted with a quick pullback movement followed by immediate extraction of samples.
15819952|NCT04285450|Dietary Supplement|Vitamin K|1mg
15819953|NCT04285450|Other|Placebo|Lactose
15819954|NCT04285437|Behavioral|infant massage|Mother will be trained how to massage their babies by International Association of Infant Massage (IAIM) Certified Infant Massage Instructor, and then their babies will be massaged by themselves during the first 2 months after birth.
15819955|NCT04285424|Biological|Fecal Microbiota Transplantation|The fecal collection produced from a single healthy donor, unrelated to the patients
15819956|NCT04285411|Device|Accuracy of the VitalDetect™ pulse oximetry system|The purpose of this study was to validate the SpO2 accuracy of the VitalDetect™ pulse oximetry system during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry. It was expected that the Accuracy Root Mean Square (ARMS) performance of the oximetry system would meet the required specification of ARMS of 3.0% or less.
15819957|NCT04285398|Other|Ophthalmic examination|Visual Acuity, Visual Field, FST, Dark adaptometry, Color Vision testing, OCT, FAF and AOSLO.
15819958|NCT04285398|Other|Mobility Test|Functional test to evaluate mobility and postural condition of patients
15819959|NCT04285385|Other|Lavender aromatherapy|0.10 ml of lavender essential oil
15819960|NCT04285385|Other|Sham aromatherapy|0.10 ml of mineral oil
15819961|NCT04285372|Procedure|Side branch protection/ballooning|Side branch protection in the context of percutaneous coronary intervention for the treatment of bifurcation lesion
15819962|NCT04285372|Procedure|No side branch protection/ballooning|No intervention on the side branch
15819963|NCT04285359|Procedure|Intracranial Interventions|Neurosurgical elective intracranial interventions: supra- and infratentorial craniotomies, transnasal endoscopic interventions.
15819964|NCT04285346|Drug|Ganaxolone|titration followed by maintenance and extension period
15819965|NCT04285333|Procedure|fascia iliaca block|ultrasound guided block with 20 mL lidocaine 1.5%
15819966|NCT04285333|Procedure|percapsular nerve group block|ultrasound guided block with 20 mL lidocaine 1.5%
15819967|NCT04285320|Drug|Intravesical antibiotic instillation|"Based on the participant's allergy and antibiotic resistance profile, one of the following three antibiotics will be instilled intravesically via a latex free BARD® 12 French Foley catheter for a total of 6-8 instillations (2 instillations/week) according to the Atlantic Health System Urogynecology Division antibiotic bladder instillation standard protocol:
~Amikacin-30 mg in 60 ml of sterile water
~Gentamycin-80mg in 60ml sterile water
~Tobramycin-80 mg in 100 ml of sterile water"
15819968|NCT04285320|Drug|Antibiotic oral suppressive therapy|"In the antibiotic oral suppression therapy arm, one of the following routinely used antibiotics will be prescribed for a total of 3 months according to the American Urogynecology Society Guidelines and based on the participant's allergy and antibiotic resistance profile:
~Trimethoprim daily (100 mg)
~Trimethoprim/sulfamethoxazole daily (40 mg/200 mg)
~Trimethoprim/sulfamethoxazole every 3 days (40 mg/200 mg)
~Nitrofurantoin monohydrate/macrocrystals daily (50 mg)
~Nitrofurantoin monohydrate/macrocrystals daily (100 mg)
~Cephalexin daily (125 mg)
~Cephalexin daily (250 mg)
~Fosfomycin every 10 days (3 grams)"
15819969|NCT04285307|Behavioral|Sleep Hygiene tips|Students receive a packet of information on how to improve their sleep habits and hygiene.
15819970|NCT04285281|Drug|Gabapentin oral capsules|Oral capsule pharmaceutical treatment.
15819971|NCT04285268|Drug|Bortezomib|Given IV or SC
15819972|NCT04285268|Biological|Rituximab|Given IV
15819973|NCT04285268|Drug|Venetoclax|Given PO
15819974|NCT04285255|Drug|Fentanyl|opioids anaesthesia
15819975|NCT04285255|Drug|Ketamine|ketamine induction and analgesia as opioids free anaesthesia versus opioids analgesia
15819976|NCT04285255|Drug|Dexmedetomidine Injection [Precedex]|alpha 2 agonist with sedative, analgesic effect
15819977|NCT04285255|Procedure|Oblique subcostal transversus abdominis plane block|Bupivacaine 0.25% injected under ultrasound usage in the transversus abdominis plane
15819978|NCT04285255|Drug|Lidocaine|infusion of lidocaine 2%(1mg/kg/h)
15819979|NCT04285242|Other|Observational assessments|Clinical assessments
15819980|NCT04285229|Drug|Ixekizumab|Administered SC
15819981|NCT04285229|Drug|Placebo|Administered SC
15819982|NCT04285216|Other|Dry Needling|Hot pack 10 mints,stretching,Neck isometrics, dry needling(DN) and Strain counterstrain(SCS)
15819983|NCT04285216|Other|Strain counter strain|Hot pack 10 mints, stretchings,Neck isometrics, Strain counterstrain(SCS)
15819984|NCT04285203|Other|Educational Video Intervention|Educational videos
15819985|NCT04285190|Drug|T89|The subjects in the T89 treatment group will receive 30 pills of T89 orally, bid., for 10 days, except a standard background treatment (antiviral drug + antibacterial + oxygen therapy+ Traditional Chinese Medicine decoction). The subjects in the blank control group will only receive a standard background treatment.
15819986|NCT04285177|Procedure|Strabismus surgery|Resection or recession of the medial or lateral rectus muscle, or inferior oblique myectomy
15819987|NCT04285151|Procedure|Nd:YAG laser Hyaloidotomy|Using the YAG laser for opening the posterior hyaloid in eyes with premacular hemorrhage, and evacuating the entrapped hemorrhage
15819988|NCT04285138|Other|phantom limb exercise|phantom limb exercises (that is, active imaginal efforts to move the phantom), under the assumption that the neural pathways involved in performing actual movements are activated when using one's imagination to move the phantom extremity
15820183|NCT04283383|Other|Primary Care Clinical Ultrasound Classroom (AECAP)|A structured training process oriented to the clinical practice of the family physician, Primary Care Clinical Ultrasound Classroom (AECAP) will be carried out,
15819989|NCT04285138|Other|conventional treatment|"Mirror therapy uses a flat mirror placed parasagittally in front of the patient's body with the reflective surface toward the sound limb so that the amputee sees the reflection of the sound limb in the mirror [Figure 1]. This reflection mimics the amputated limb, and with the movement of the intact limb, the mirror provides an optical illusion that the phantom limb is moving simultaneously.
~Equipment:
~Therapy mirror: A standing mirror (130 cm × 46 cm) with wooden frame and base (62 cm × 65 cm) Routine physiotherapy The general exercise programme consisted of strengthening, stretching, dynamic, and isometric exercises based on the level of amputation and their assessment results. Participants allocated to the control group were advised to continue rehabilitation at their respective physiotherapy out-patient departments as frequently as possible. Participants were given a diary and advised to record their activities, specifying the nature, frequency and duration of each activity"
15819990|NCT04285125|Other|cerebral MRI|Patients who agree to participate in the study will perform an MRI with ultra high resolution sequences added by the research MRI of control will be done at one year and two years
15819991|NCT04285099|Device|Application of dual system in frequency A|The investigators set two values of frequency (130, 60Hz) in IPG and allow the patients to change the frequencies freely using the patient controller. Technician randomly sets 130 Hz, 60HZ to A or B.
15819992|NCT04285099|Device|Application of dual system in frequency B|The investigators set two values of frequency (130, 60Hz) in IPG and allow the patients to change the frequencies freely using the patient controller. Technician randomly sets 130 Hz, 60HZ to A or B.
15819993|NCT04285086|Biological|Ropeginterferon alfa-2b|Ropeginterferon alfa-2b (P1101) dosage: from 250 mcg to 500 mcg Anagrelide dosage: 0.5 mg per capsule, according to label and physician's judgement
15819994|NCT04285073|Device|Paclitaxel-eluting graft|Implantation of e-PTFE Grafts inner surface-treated with paclitaxel as access for hemodialysis
15819995|NCT04285060|Device|Samsung GEMS-H|Subjects will participate in 18 sessions of training in the outpatient clinic with a licensed physical therapist. Therapy sessions will include 30 minutes of task specific training and another 15 minutes of the session can be used to focus on patient specific goal areas related to functional mobility and balance. Training sessions will occur 2-3 times a week for 6-8 weeks to complete the training protocol.
15819996|NCT04285047|Other|Advancing Patient Experience (APEX) in COPD|Involves both EMR and PRIO data
15819997|NCT04285008|Device|Pure-Vu System|The Pure-Vu System is Food and Drug Administration (FDA) approved device (K191220), intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and other bodily fluids and matter, e.g. blood.
15819998|NCT04284995|Drug|RUC-4 Compound|All patients will receive a single subcutaneous dose of RUC-4 in the Cardiac Catheterization Lab (CCL) before coronary angiography/percutaneous coronary intervention.
15819999|NCT04284982|Behavioral|16-week supervised heavy resistance training program with weekly undulating periodization|Participants trained a whole-body program consisting of squat, bench press, deadlift and pendlay row two times per week for 16 weeks
15820000|NCT04284969|Behavioral|PROADAPT program|"A pre-intervention activity by telephone follow-ups every week for 12 weeks and then every month.
~Pre-operative physical training including strength, endurance and breathing exercises.
~A nutrition activity.
~An activity to educate patients (on nutrition, exercise).
~The implementation of standardised intervention procedures, established in agreement with the surgeons' representatives.
~A pharmaceutical drug conciliation activity: optimization of the patient's different treatments with pharmaceutical expertise.
~A transition activity from the hospital to the home, and a telephone follow-up up to 12 weeks after the surgery."
15820001|NCT04284956|Procedure|Proximal and distal segment of saphenous vein harvested by No-Touch technique|two longitudinal incisions are made on the thigh and shank from unilateral lower limb (for harvesting of proximal segment of saphenous vein, incision is started from about 3 or 4cms inferolateral to the pubic tubercle and then extended downward). As previous reported. the adventitia and perivascular tissue are carefully kept intact to avoid damage. Then a margin of about 5 mm from both sides of the vein is created to include the fat pedicle using electrocautery, and all visible side branches are ligated with 4-0 silk or by metal clipping (branches are divided at the pedicle margin rather than the vein trunk). The saphenous vein is then separated from its bed using scissors and electrocautery, together with surrounding tissue.
15820002|NCT04284943|Procedure|Long limb Roux-en-Y reconstruction after subtotal gastrectomy|The jejunum will be divided approximately 150 cm distal to the ligament of Treitz (Length of biliopancreatic limb). The gastrojejunostomy will be performed by end-to-end anastomosis and an anastomosis of the proximal end of the jejunum to the distal jejunum will be created approximately 50 cm distal from the gastrojejunal anastomosis (Length of Roux-en-Y limb).
15820003|NCT04284943|Procedure|Conventional Roux-en-Y reconstruction after subtotal gastrectomy|The jejunum will be divided approximately 20 cm distal to the ligament of Treitz (Length of biliopancreatic limb). The gastrojejunostomy will be performed by end-to-end anastomosis and an anastomosis of the proximal end of the jejunum to the distal jejunum will be created approximately 30-45 cm distal from the gastrojejunal anastomosis (Length of Roux-en-Y limb).
15820004|NCT04284943|Procedure|Billroth II reconstruction after subtotal gastrectomy|The duodenum will be transected approximately 2 cm distal to the pylorus and anastomosis will be performed between the gastric remnant and a loop of jejunum chosen approximately 20 cm distal to the ligament of Treitz (Length of afferent loop)
15820005|NCT04284930|Drug|Depobupivacaine|surgeons receive schematic for injection of Depobupivacaine. Subjects receive an injection of 166mg depobupivacaine. Injection on either side of the suture line, injected directly into the fascia.
15820006|NCT04284930|Drug|OnQ pump|group 2: Surgeons receive instruction sheet with specific placement of catheter. All patients have two OnQ soaker catheters installed into abdominal donor site before donor closure.
15820007|NCT04284930|Drug|0.25% Bupivacaine|group 3: given 0.25% bupivacaine without epinephrine between internal oblique and transverse abdominal muscle.
15820040|NCT04284592|Procedure|Remote ischemic post-conditioning (RIP)|The limb RIP was applied after leaving of cardiopulmonary bypass and consisted of 3 cycles: 5 min of ischemia by a cuff-inflator on an arm and inflated to 200 mmHg, followed by 5 min deflated. The control group had during the same time a deflated cuff.
15820041|NCT04284579|Device|IV cannula|We measure the time duration needed for IV cannulation
15820213|NCT04283162|Other|conventional treatment|maintain lifestyle habits and the usual treatment
15820008|NCT04284917|Drug|Carglumic Acid (Carbaglu®)|"A. Study period: 24 months; treatment period: 12 months.
~B. Patients will receive Carglumic Acid (Carbaglu®) 50 mg/kg/day in addition to standard therapy (protein restricted diet, L-carnitine, metronidazole and vitamin B12)
~C. Patients need to regularly come back for follow up examination on Day 0, month 3, month 6, and month 12. (Check Plasma Amino Acid Analysis, Ammonia, acylcarnitine profile, Urinary organic acid analysis.)
~D. Patients should report any adverse event that occur during treatment period.
~E. Patients' number of emergency visits due to hyperammonemia, ammonia level, acylcarnitine, urinary organic acid analysis, plasma amino acid analysis will be recorded during treatment period."
15820009|NCT04284904|Diagnostic Test|aGVHD biomarker|To verify the effectiveness of aGVHD biomarkers monitoring in predicting aGVHD risks
15820010|NCT04284878|Genetic|PCR-RFLP|PCR-Restriction fragment length polymorphism
15820011|NCT04284865|Other|Web Platform|The intervention involves the use of the web platform for 12 months combined with a monthly phone follow-up.
15820012|NCT04284852|Drug|Niraparib|PARP inhibitor
15820013|NCT04284839|Drug|DOAC|Patients will receive a DOAC at doses recommended for the indication, adjusted for their renal function is required. The choice of DOAC will be at the discretion of the treating physician.
15820014|NCT04284839|Drug|VKA|Patients in the control group will receive VKA once daily; the individual dose will be titrated to achieve a guideline-recommended INR range.
15820015|NCT04284826|Procedure|Endoscopic injection of Mitomycin-C on bougie-dilated refractory benign esophageal stricture|
15820016|NCT04284813|Behavioral|CRAFT-FT|CRAFT-FT will be delivered via telemedicine. Topics include building motivation, self-care, communication, understanding patterns of behavior, positive reinforcement, and negative consequences. The intervention will be tailored to families of individuals experiencing psychosis and substance use who are enrolled in first episode psychosis outpatient services. Participants will be asked to completed assessments at pre-treatment, mid-treatment (approximately week 3), post-treatment, and a follow-up assessment approximately 3 month post-treatment.
15820017|NCT04284787|Drug|Azacitidine|Given IV or SC
15820018|NCT04284787|Biological|Pembrolizumab|Given IV
15820019|NCT04284787|Drug|Venetoclax|Given PO
15820021|NCT04284761|Combination Product|Bicalutamide implant|Biolen bicalutamide implant
15820022|NCT04284748|Other|Plyometric exercise with blood flow restriction|"Blood flow restriction training is an exercise protocol based on the method of limiting blood flow with external pressure by pneumatic tourniquet from the proximal of the muscle to be strengthened. Blood flow restriction (Occlusion) during pliometric exercises for 8 weeks, a pneumatic tourniquet (Kaatsu Master) proximal to the thigh will be applied to each patient within a safe pressure range. The pressure to be applied to the patient will be calculated with the following formula described in the literature.
~Pressure = 0.5 x (systolic blood pressure) + 2 x (thigh circumference) + 5 Application will be done for a maximum of 15 minutes, then rest for 10-15 minutes and other exercises will continue.
~Plyometric training with blood flow restriction. Jump in functional squat system (30+15+15+15= 75 rep) Lunge jump (30 rep) Side jump (30 rep) Box jump (15 rep) Exercises to be added after 4 weeks; Square jump (15 rep) One leg hop (15 rep)"
15820023|NCT04284748|Other|Plyometric exercise|Plyometric training Jump in functional squat system (30+15+15+15= 75 rep) Lunge jump (30 rep) Side jump (30 rep) Box jump (15 rep) Exercises to be added after 4 weeks; Square jump (15 rep) One leg hop (15 rep)
15820024|NCT04284748|Other|Routine physiotherapy program|Anterior and lateral plan exercise (3x10 rep) Open kinetic quadriceps and hamstring strengthening exercise (3x10 rep) Lunge exercises on different ground (3x10 rep) Single leg squat exercise on different ground (3x10 rep) Anterior and lateral walking exercise in a squatting position with an exercise band (40 step) Balance and proprioceptive exercises
15820025|NCT04284735|Other|Quantitative ATX and LPA determination in plasma and sputum|"Determination of ATX and LPA levels in plasma and sputum from RA-ILD patients (cases) and in plasma and sputum from RA patients without ILD (controls) after sputum induction using hypertonic saline inhalation"
15820026|NCT04284722|Drug|Metformin Hydrochloride|Perioperative continuation of oral metformin therapy according to the patient's normal dosage and dosage intervals
15820027|NCT04284709|Other|cognitive-physical training|combined physical and cognitive training
15820028|NCT04284696|Dietary Supplement|Pregnan-C-Gum(R) chewing gum|"Using a chewing gum with 150mg vitamin C (per piece/gum) for 14 days ad libitum"
15820029|NCT04284696|Dietary Supplement|Placebo chewing gum|"Using a chewing gum without vitamin C (per piece/gum) for 14 days ad libitum"
15820030|NCT04284683|Other|DRINK - Water, Protein, Fat, Carbohydrate|Following exercise participants will consume a drink (with different composition in each visit) and than RMR will be evaluated.
15820031|NCT04284670|Other|EXERCISE|The intervention group will perform an 8 week program, 2 sessions a weak for a total of 16 sessions. training will be done on a designated negative gradient treadmill, first two session will be in -5% gradient. sessions 3,4 and 5 will be in -10% gradient, all of the following sessions will be in -15% gradient. exercise intensity will be 70%-80% out of maximal heart-rate. Session length will gradually increase by one minute each training, starting from 10 minutes at the first session, up to 25 minutes on final sessions. each training will start and end with a 2 minutes of warm up and calm down under neutral gradient. Every two minutes of training, Visual Analog Scale and Rating of Perceived Exertion data will be collected from the participants.
15820032|NCT04284657|Drug|Pravastatin|Pravastatin 40 mg QD
15820033|NCT04284657|Drug|sodium citrate|sodium citrate up to 30 ml TID
15820034|NCT04284644|Drug|Induction using propofol|Patients were given 1.5 mcg/Kg of fentanyl intravenously. two minutes after the fentanyl dose, a dose of 1.5 mg/kg of propofol slowly over 2 minutes.
15820035|NCT04284644|Drug|Induction using sevoflurane|Patients were given 1.5 mcg/Kg of fentanyl intravenously. two minutes after the fentanyl dose, patient received 8% inhalational sevoflurane through sealed plastic face mask at 8 L/min flow of oxygen.
15820036|NCT04284644|Drug|Induction using propofol and sevoflurane|Patients were given 1.5 mcg/Kg of fentanyl intravenously. two minutes after the fentanyl dose, patient received 4% sevoflurane through sealed plastic face mask at 8 L/min flow of oxygen for 2 minutes, followed by a dose of 0.75 mg/kg of propofol given slowly.
15820214|NCT04283149|Device|EVO Visian ICL for Myopia|The EVO MICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
15820042|NCT04284566|Behavioral|TAU + multicomponent treatment FIBROWALK|"Group treatment protocol of 12 weekly 120 minute sessions. All sessions include the following ingredients (approx. in the same order):
~Pain neuroscience education (30 min.)
~Cognitive restructuring (30min.)
~Mindfulness techniques (30 min.)
~Physical exercise(30 min.)
~Treatment as Usual (TAU) Standard pharmacological treatment usually provided to patients with fibromyalgia."
15820043|NCT04284566|Behavioral|Treatment as Usual (TAU)|Treatment-as-Usual (TAU) consisted of prescribing drugs adapted to the symptomatic profile of each patient. The patients were instructed to continue their baseline medical treatment with no change throughout the 3-month period. In Spain, some counselling about aerobic exercise adjusted to patients' physical limitations is usually provided by first-line clinicians and specialists, but pharmacotherapy it's still the dominant treatment option.
15820044|NCT04284553|Other|Order Entry|An alert will display in the electronic health record when the provider orders one of the high-risk medications for an eligible patient.
15820045|NCT04284553|Other|Open Encounter|An alert will display in the electronic health record when the provider opens the chart of an eligible patient.
15820046|NCT04284553|Other|Follow-up booster Alert|Once the order entry or open encounter alert displays, the provider will have the option to schedule a follow-up message that will be sent 4 weeks after the alert is triggered
15820047|NCT04284553|Other|Cold State outreach|An in-basket message will be sent to the eligible provider 2 days before the eligible patient is scheduled for an in-person visit.
15820048|NCT04284553|Other|Simplified|The alert language itself will be simplified.
15820049|NCT04284553|Other|Sign-off alert|An alert will display in the electronic health record when the medication is sent to sign-off for providers.
15820050|NCT04284553|Other|Pre-commitment|A two-staged pre-commitment electronic health record alert will be used. In the 1st alert, the providers will be prompted to discuss risks of these high-risk medications and share a handout about the risks with their patients, at their own discretion. The second alert will be either an order entry or open encounter alert, depending on the arm the provider is assigned to.
15820051|NCT04284553|Other|Different Risks|Risks of the high-risk medications will be framed differently.
15820052|NCT04284553|Other|Standard Epic Basic Alert|This alert will be representative of the alerts currently firing in the Atrius system and not incorporate any functionality.
15820053|NCT04284553|Other|Enhanced Alert|An enhanced alert (known as a Best Practice Advisory [BPA]) will appear on the provider's electronic health record screen and will contain several standard components such as information about why the medication is dangerous for their patient and an order set that will allow providers to order a gradual dose taper for their patient, order alternative medications, place a referral to a behavioral health specialist, provide instructions on how to make lifestyle modifications to improve patient symptoms, and add patient instructions for how to gradually taper off benzodiazepines and sedative hypnotics, as applicable.
15820054|NCT04284540|Radiation|Adjuvant hypofractionation|15 fractions of 2.7 Gy per fraction daily over 3 weeks for a total of 40.5 Gy to the post-operative bed and/or necks.
15820055|NCT04284540|Radiation|Definitive Hypofractionation|15 fractions of 3 Gy per fraction daily over 3 weeks for a total of 45 Gy to regions of gross disease. Elective areas can be treated to 37.5 Gy in 15 fractions.
15820056|NCT04284527|Other|Observational study|a reliability - validity study
15820057|NCT04284514|Drug|AKB-9778 Ophthalmic Solution|AKB-9778 Ophthalmic Solution
15820058|NCT04284514|Drug|Placebo Ophthalmic Solution|Matched vehicle-control
15820059|NCT04284501|Behavioral|Non|questionnaire
15820060|NCT04284488|Drug|APG-1387 for Injection|APG-1387 IV on Days 1 and 8 of each 21-Day Cycle. The following doses of APG-1387 to be studied: 20, 30, and 45mg. In the phase II, the assigned recommended phase two dose will be administered in all cohorts.
15820061|NCT04284488|Drug|Toripalimab|240 mg toripalimab IV on Day 1 of each 21-Day Cycle
15820062|NCT04284475|Diagnostic Test|Quadriceps strength|Using a handheld dynamometer, in supine position in a standardized position of the dominant leg Measurement of the maximal isometric voluntary quadriceps contraction Measure expressed as Newton and Newton/kg
15820063|NCT04284475|Diagnostic Test|Grip strength|Testing of dominant hand using a handgrip Measurement of the maximal isometric voluntary grip contraction Measure is expressed as kg
15820064|NCT04284475|Diagnostic Test|ICU mobility scale|Scoring the physical capacity of the patient on a 10-points validated scale: the ICU mobility scale
15820065|NCT04284462|Other|Flavored carbonated soft drink (CSD)|1-2 cans/day (330 ml per can)
15820066|NCT04284449|Other|Whole-practice cognitive optimization|This intervention is a whole-practice intervention that may include nutritional assessment & supplementation, determination of food sensitivities and dietary changes, natural products such as herbal anti-inflammatories, assessment of whole body-burden of toxicants (such as heavy metals and fungal toxins) and steps to reduce exposures, and behavioral changes such as exercise, meditation, and sleep hygiene optimization.
15820067|NCT04284436|Behavioral|Treadmill walking|Treadmill walking 4 days per week for 30 minutes in the target heart rate
15820068|NCT04284423|Diagnostic Test|joint fluid lactate|Analysis of lactate level in joint fluid to determine presence of septic joint
15820069|NCT04284410|Behavioral|CLASP-PE arm|Participants will complete 8-16 weekly or twice weekly individual therapy sessions (with total session number determined by clinical need, as is typical in clinical trials of PE for PTSD), 1 therapy session (session 3) with a supportive significant other (SO), consistent with the CLASP protocol, and 11 brief (30 minute) phone calls as possible, with calls occurring every week in between therapy sessions and on a less frequent basis following treatment termination up to 3 months after the final in-person therapy session. In addition, the supportive SOs will complete 11 brief (30 minute) phone calls with the therapist at the same frequency as participants. Participants will sign a release of information prior to involving the supportive significant other in treatment.
15820070|NCT04284397|Drug|Low dose ASA|A sub-group of older adults will be re-tested after 7 days of treatment with low-dose aspirin.
15820071|NCT04284397|Other|Control|All participants will be tested with no treatment.
15820215|NCT04283149|Device|EVO Visian Toric ICL for Myopia with Astigmatism|The EVO TICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
15820278|NCT04282642|Behavioral|Cognitive Training|Participants (n=20) provided game console with cognitive training games and activities.
15820072|NCT04284358|Other|Technology integrated instruction neuromuscular training warm-up workshop|Participants will learn of the exercises with a traditional instructor demonstration and verbal explanation. Participants will then attempt the exercise and assess their execution via a video on a peer learning tablet application. This occurs for every exercise and occurs in pairs in which participants can discuss and evaluate an exercise by an exercise's key execution components.
15820073|NCT04284345|Procedure|Saline Pd/Pa|"Use of a ≥6F guiding catheter and the Verrata pressure guidewire. Administration of intracoronary nitroglycerin.
~Verrata normalisation and placement of the Verrata sensor ≥3 vessel-diameter beyond the stenosis.
~Whole cycle resting Pd/Pa and resting iFR measurements.
~Measurement of contrast FFR: record 5 baseline heart beats, injection of contrast media, 10 ml in the left coronary system, 8 ml in the right coronary system, measure minimal Pd/Pa under stable hyperaemia.
~Adenosine FFR: measurement: record 5 baseline heart beats, injection of intracoronary adenosine, 200 mcg in the left coronary system, 100 mcg in the right coronary system, measure minimal Pd/Pa under stable hyperaemia.
~Saline-induced Pd/Pa measurement: record 5 baseline heart beats, injection of saline using the ACIST system during 5 heart beats, measure minimal Pd/Pa under stable hyperaemia.
~Perform pressure guidewire pullback and check for drift: drift ±0.02 is accepted, if ≥0.03, repeat measurement."
15820074|NCT04284319|Procedure|DCD Heart Transplantation Using NRP|Heart Transplantation Using Normothermic Regional Perfusion (NRP) Donation After Circulatory Death (DCD)
15820075|NCT04284293|Biological|CNS10-NPC implantation|All patients will receive a single, unilateral, subretinal injection of CNS10-NPC
15820076|NCT04284280|Dietary Supplement|Routine vs Selective use of Human Milk Donor Fortifier|Infants will be randomized to two groups. Both groups will be fed Premature Human Milk (either Maternal own milk or Premature donor human milk). However, one group will get fortified with Donor Human Milk Fortifier once full feed is reached while the second group will get fortified using the same fortifier only when weight gain is suboptimal.
15820077|NCT04284267|Device|Transcranial Magnetic Stimulation|TMS is a non-invasive tool for modulating patterns of brain activation and circuit connectivity. It uses electromagnetic pulses to induce electric currents over the cortex that serve to depolarize or hyperpolarize neurons, thereby changing patterns of synaptic activity. This study will use intermittent theta burst stimulation (iTBS), an efficient TMS protocol that uses high frequency (50Hz) triplets of TMS given every 200 milliseconds (i.e. at 5 Hz).
15820078|NCT04284254|Drug|Autologous Plasmablasts|"Autologous Plasmablasts engineered to express α-L-iduronidase (IDUA) using the Sleeping Beauty transposon system.
~Phase 1:
~Dose Level 1: 5 x 10e7 cells/kg on Day 0
~Dose Level 2: 1 x 10e8 cells/kg on Day 0
~Dose Level 3: 1 x 10e8 cells/kg x 2 doses on Day 0 and Day 30 +/-3 days.
~Phase 2:
~- Maximum Tolerated Dose (MTD) established in Phase I"
15820079|NCT04284241|Behavioral|Parents'Health-Education Handbook|We created a Parents' Health-Education Handbook to teach the newborns' parents to enhance their knowledge of pediatric stone, with a view to changing parents' cognition, attitude and behavior for preventing pediatric stone formation by this cluster randomized control trail.
15820080|NCT04284228|Biological|Infusion of NEXI-001 T Cells|"Procedure: A single IV infusion of NEXI-001 T Cells at Day 1 after Lymphodepletion(LD) Therapy.
~At dose Level 1: 1.0 x 108 total viable T cells At dose Level 2: 2.0 x 108 total viable T cells
~Procedure: Lymphodepletion: IV administration of fludarabine 30 mg/2 and cyclophosphamide 300 mg/m2 for 3 days.
~lymphodepletion (LD) Therapy: Subjects will received bridging therapy agents during lymphodepletion for 3 consecutive days prior to receiving the NEXI-001 product
~Drug: Fludarabine
~Fludarabine infusion
~Other Name: Fludarabine monophosphate
~Drug: Cyclophosphamide
~Cyclophosphamide infusion
~Other Name: Cytoxan"
15820081|NCT04284215|Drug|Albumin paclitaxel combined with cisplatin|Non-resectable stage III non-small cell lung cancer is recommended for concurrent chemoradiotherapy. Paclitaxel and platinum are commonly used in chemotherapy regimens. The aim of this study was to investigate whether paclitaxel albumin combined with cisplatin combined with three-dimensional primary radiotherapy could improve short-term efficacy, local progression-free survival, and reduce treatment-related toxicity. To determine whether paclitaxel albumin combined with cisplatin regimen chemotherapy can be used as a first-line treatment for stage III non-small cell lung cancer with concurrent primary thoracic radiotherapy.
15820082|NCT04284202|Drug|PD-1 plus Dasatinib|Toripalimub 240mg injection day1; Dasatinib 100mg po qd day1-day21. 3weeks is 1 cycle.
15820083|NCT04284189|Other|Transition model|Transition of follow-up care of childhood cancer survivors to adult care
15820084|NCT04284176|Other|Mirror therapy and action-observation therapy|The mirror therapy and action-observation therapy group will receive for 20 days a daily therapy of 15 minutes at home of MT and 45 of AOT, whereas the action-observation therapy group will receive 60 minutes of AOT.
15820085|NCT04284163|Behavioral|Gamification|Teaching through gamification
15820086|NCT04284163|Behavioral|Traditional teaching|Teaching through master lesson methodology
15820087|NCT04284150|Drug|Dexmedetomidine; Midazolam;|Treatment of supraventricular tachycardia in patients with non-cardiac surgery by dexmedetomidine during the perioperative period
15820088|NCT04284137|Behavioral|Modified FE-SaLiR|Participants will attend a 60-minute exercise program (modified Wu Qin Xi and Ba Duan Jin) in a non-clinical community setting twice a week and will perform the exercises at home using guided video up to three times a week. Text messages will be sent to remind the participants to do the exercise at home.
15820089|NCT04284137|Behavioral|Unmodified Chinese Medicine Exercise|Participants will attend a 60-minute exercise program (Wu Qin Xi and Ba Duan Jin published by the General Administration of Sport of China) in a non-clinical community setting twice a week and will be expected to practice exercise at home using guided video up to three times a week. Text messages will be sent to remind the participants to do the exercise at home.
15820090|NCT04284137|Behavioral|Active Control|Participants will attend a 60-minute health education program once a week.
15820116|NCT04283955|Drug|High-dose MTX based chemotherapy|Patients received MTX therapy at the dose of 5g/m2 for 24 hours. Each dose of HD-MTX therapy was followed by 6~7 times of leucovorin rescue 12 hours after the end of MTX infusion, at the dose of 15 mg/ m2 every 6 hours. The plasma MTX levels were monitored at 0, 24, 48, 72 hours from the initiation of HD-MTX infusion. To maintain the urine pH at approximately 7~8, intravenous hydration and alkalization at the dose of 1,500ml/ m2 per day were achieved 12 hours prior to the initiation of HD-MTX administration (D0) and 3,000ml/ m2 per day lasted for the following 3 days (D1 to D3). CF was used to rinse mouth to prevent oral mucositis from D1 to D3. We closely monitored the volume and pH of the urine via routine test from D0 to D4.
15820091|NCT04284124|Other|Erector Spinae block|Patient in the prone position 20 min before induction of general anesthesia. Skin is sterilized by 10% povidone iodine. An US multifrequency convex probe (1-8 MHz) will be used for block. A 22G, 50-mm in length needle will be used and block will be performed at the T4 level of the spine using in-plane approach where a convex probe is placed 2-3 cm lateral to the spine using sagittal approach. Erector spinae muscle and the transverse processes are located and the needle will be inserted deep into the muscle. The needle is directed craniotomy-caudally. Correct position of the needle tip is confirmed with administration of 0.5-1 ml of local anesthetic to monitor spread then 20 ml of 0.25% bupivacaine will be administered for block performance. Distribution of local anesthetic is monitored in both cranial and caudal directions
15820092|NCT04284111|Device|Orthokeratology lenses|Orthokeratology lenses
15820093|NCT04284098|Other|General anesthesia (GA).|Patients received standard GA including fentanyl as intraoperative analgesic and morphine as postoperative analgesic in the first 24 hours.
15820094|NCT04284098|Other|PECS block using bupivacaine .|The patients undergo an ultrasound-guided PECS I using 10 ml bupivacaine 0.25% and PECS II using 20 ml bupivacaine 0.25%, after 10-minutes observation the patients receive standard GA including fentanyl as intraoperative analgesic and morphine as postoperative analgesic in the first 24 hours.
15820095|NCT04284098|Other|PECS block using bupivacaine and dexmedetomidine|D group:The patients undergo an ultrasound-guided PECS I using 10 ml bupivacaine 0.25% and PECS II using 20 ml bupivacaine 0.25%+dexmedetomidine (1µg/kg) after 10-minutes observation the patients receive standard GA including fentanyl as intraoperative analgesic and morphine as postoperative analgesic in the first 24 hours.
15820096|NCT04284085|Other|Psychoeducational intervention|Psycho-educational groups of 10 to 12 people, led by two professionals, one of them will always be a psychologist and an educator. In some sessions, other collaborators will be invited to participate, such as psychiatrists, educators, social workers, etc. who may act as external observers or implement the session. The number of sessions will be 13, one or two sessions a week and duration of 90 minutes.
15820097|NCT04284072|Device|Sensor Dot|Multimodal (EEG, ECG, EMG and motion) seizure monitoring with Sensor Dot to complement EMU-based video-EEG monitoring (EMU Phase), and optional home-based seizure diary logging (Home Phase).
15820098|NCT04284059|Drug|Placebos|Placebo, vitamin AD and vitamin D are identical in the appearance to guarantee blind. The patients need to administrate 3 capsules once a day for 8 weeks.
15820099|NCT04284059|Dietary Supplement|vitamin AD|A vitamin AD capsule contains vitamin A 2000 IU and vitamin D 700 IU. The patients need to administrate 3 capsules once a day for 8 weeks.
15820100|NCT04284059|Dietary Supplement|vitamin D|A vitamin D capsule contains vitamin D 400 IU. The patients need to asministrate 6 capsules/time, once a day for 2 weeks, then change to 5 capsules/time, once a day for 6 weeks.
15820101|NCT04284046|Other|CT score|CT score = normal lung tissue (%) ×1 + GGO (%) ×2 + consolidation (%) ×3
15820102|NCT04284033|Device|Extended Wear Infusion Set|For two of the 4 weeks, the Extended Wear insulin infusion set will be used
15820103|NCT04284033|Device|Standard Infusion Set|For two of the 4 weeks, the standard insulin infusion set will be used
15820104|NCT04284020|Behavioral|Therapeutic educational program|See arm/group descriptions
15820105|NCT04284020|Other|PFMT|See arm/group descriptions
15820106|NCT04284020|Other|TTNS|See arm/group descriptions
15820107|NCT04284007|Drug|Perineural levobupivacaine|Patients will receive 20 ml of 0.25% levobupivacaine plus 2ml saline in interscalene brachial plexus block plus 10 ml intravenous saline.
15820108|NCT04284007|Drug|Perineural dexamethasone in addition to levobupivacaine|Patients will receive 20 ml of 0.25% levobupivacaine plus 4mg dexamethasone diluted in 2 ml saline in interscalene brachial plexus block plus 10 ml intravenous saline.
15820109|NCT04284007|Drug|Intravenous dexamethasone with perineural levobupivacaine|Patients will receive 20 ml of 0.25% levobupivacaine plus 2ml saline in interscalene brachial plexus block plus 4 mg intravenous dexamethasone diluted in 10 ml saline.
15820110|NCT04283994|Behavioral|Survey-based Patient/Clinician Jumpstart|"The Jumpstart Guide is a communication-priming intervention for clinicians, patients and their families that addresses hospitalized patients' goals of care. The intervention's goal is to prompt clinicians to provide standard of care which includes a discussion with patients or their legal surrogate decision-maker about their goals of care. The Jumpstart takes two forms. One is EHR-based and provides information to the clinician about prior advance care planning documentation derived from the EHR. The other is bi-directional and patient-specific (Survey-based Patient/Clinician Jumpstart Guide). It provides the same information as the EHR-based Clinician Jumpstart Guide but also includes information about patients' self-reported preferences for communication and care as well as primary barriers and facilitators to this communication. The Jumpstart Guides include tips to improve this communication for clinicians, patients and families."
15820111|NCT04283994|Behavioral|EHR-based Clinician Jumpstart|The Jumpstart Guide is a communication-priming intervention for clinicians that addresses hospitalized patients' goals of care. The intervention's goal is to prompt clinicians to provide standard of care which includes a discussion with patients or their legal surrogate decision-maker about their goals of care. The one-page EHR-based Clinician Jumpstart Guide provides information to the clinician about prior advance care planning documentation derived from the EHR. The EHR-based Clinician Jumpstart Guide includes tips to improve goals-of-care communication.
15820112|NCT04283981|Device|Control group without use of VSP|The control group will include patients that undergo mandibular reconstruction via open reduction internal fixation (intraoral or extraoral approach) in standard fashion (without virtual surgical planning assistance and occlusal splint)
15820113|NCT04283981|Device|Treatment Group with use of VSP|The treatment group corresponds to patients undergoing mandibular reconstruction via open reduction internal fixation (intraoral or extraoral approach) utilizing virtual surgical planning via 3D Systems, bite registration and fabrication of occlusal splint via intraoral digital scanner, and mandibular hardware
15820114|NCT04283968|Biological|Fecal Microbial Transplantation|Fecal Microbial Transplantation in adults with Atopic Dermatitis
15820115|NCT04283968|Biological|placebo fecal transplantation|placebo fecal transplantation
15820141|NCT04283682|Behavioral|Early skin-to-skin combined with breast-feeding|Premature infants in the intervention group have access to skin-to-skin once a day for 1 hour at least once no ventilation support needed. During the skin-to-skin period,the breastfeeding is encouraged for about 5-10 minutes. The whole intervention stop until the baby achieve the full oral feeding.
15820117|NCT04283942|Behavioral|Intermittent caloric restriction|Intermittent calorie restriction is a new strategy of reducing weight and improving health. The most common ICR methods include alternative day calorie restriction (ACR) and 5:2 intermittent fasting (fasting 2 days each week). The food consumption in non-fasting day is not limited. We plan to apply the 5:2 intermittent fasting. Intermittent caloric restriction can effectively reduce weight, improve body composition (i.e., reduce fat content while maintaining lean body weight), reduce risk factors of cardiovascular disease (including reducing blood pressure, improving blood lipid level, reducing oxidative stress), and also facilitate blood glucose control (by increasing insulin sensitivity and improving the function of islet β cells).
15820118|NCT04283942|Behavioral|25kcal/kg/d diet|For each day, the daily calories intake = 25 kcal / kg × standard weight [kg, male: height (cm) - 105, female: height (cm) - 100].
15820119|NCT04283929|Other|Experimental: Intervention 1 (Int1)|This intervention will consist of the following additions to the EMR package. A link on the clinician's homepage to enrol a new HIV+ patient in the EMR which will open a form for (1) entering patient demographics (2) adding the contact home address or description of area, phone number (if available), (3) the peer educator contacts (4) recording the HIV+ result and date. A report will be added that is run every week to identify HIV+ patients not linked to care. The patients identified will be checked with paper records to ensure they have definitely not visited, then contacted after one, 2 weeks and 4 weeks if he/she did not show up. After two attempted contacts, if the patient is not yet linked to care he/she will be visited at home by the health facility social worker using routine home visits by health care providers.
15820120|NCT04283929|Other|Experimental: Intervention 2 (Int2)|The data on availability of VL results in the EMR will come from a SQL statement to query the OpenMRS database. An alert will be fired if the patient has been enrolled for 8 months or more and does not have a viral load result in the EMR. The alert will be displayed on the patient summary and on the consult sheets, with text requesting the clinician orders a VL.
15820121|NCT04283929|Other|Experimental: Intervention 3 (Int3)|The data on VL results in the EMR showing detectable virus will come from a SQL statement to query the OpenMRS database. An alert will be fired if the patient has been enrolled for at least 12 months and the VL result in the EMR shows > 1000 copies/mm3. The alert will be displayed on the patient summary and on the consult sheets requesting actions to address treatment failure (change first line medication, start second line medication, repeat VL, counselling on treatment adherence). A report will also be added to regularly check for patients with high viral load.
15820122|NCT04283916|Drug|Botulinum Toxins|Botulinum toxin injection to abdominal wall
15820123|NCT04283903|Diagnostic Test|PICF|PICF collection from 4 sites
15820124|NCT04283890|Drug|Ipilimumab and nivolumab|The effect of ipilimumab and nivolumab has previously been tested in metastatic uveal melanoma. In this study the combination with percutaneous hepatic perfusion will be performed in order to evaluate the effect.
15820125|NCT04283890|Drug|Melphalan chemosaturation via percutaneous hepatic perfusion|The effect of ipilimumab and nivolumab has previously been tested in metastatic uveal melanoma. In this study the combination with percutaneous hepatic perfusion will be performed in order to evaluate the effect.
15820126|NCT04283877|Drug|Methylphenidate|3 x 10 mg oral tablets. Single acute dose for all participants
15820127|NCT04283877|Drug|Placebo oral tablet|3 x 10 mg oral lactose tablet for all participants
15820128|NCT04283851|Diagnostic Test|testing functional haemodynamic parameters for preload assessment|dynamic testing of preload responsivity plus echocardiography
15820129|NCT04283838|Behavioral|Humanistic Care|Psychological and physical rehabilitation based humanistic care regimen
15820130|NCT04283825|Behavioral|Psychological and physical rehabilitation based humanistic care|This Psychological and physical rehabilitation based humanistic care regimen is generated from the experience of the National medical team members in Wuhan, from our hospital. In addition to the routine therapy, we will apply this comprehensive humanistic care regimen to the patients according to their condition. The patients will be stratified by the severity and receive different combinations of Psychological and physical rehabilitation activities.
15820131|NCT04283812|Device|DBS Electrode Implantation using D1 Sterotactic System|Treatment intervention will consist of subjects undergoing Mayo Clinic standard deep brain stimulation surgery specific to their diagnosed neurological disorder consisting of implantation of stimulating electrodes using the D1 stereotactic system.
15820132|NCT04283799|Dietary Supplement|A new human milk fortifier|Contents of protein, protein/energy ratio, moderate hydrolysis of whey protein, medium-chain fatty acid are increased in the new HMF
15820133|NCT04283786|Other|Qualitative Interview|A single qualitative interview about experiences of bisphosphonate regimens, as well as wider experiences of service quality and delivery.
15820134|NCT04283773|Combination Product|p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267)|Treatment of slides that cut from paraffin embedded blocks related to groups by immunohistochemical method by p16INK4a Recombinant Rabbit Monoclonal Antibody (RM267).
15820135|NCT04283773|Combination Product|Ki67 antibody (DAKO) for malignant cases only|Treatment of slides that cut from paraffin embedded blocks related to malignant case group by immunohistochemical method by Ki67 antibody.
15820136|NCT04283747|Diagnostic Test|Serum immunoglobulin titer|Serum IgG and IgM levels, VZV titer every 6 month at before rituximab administration 3 times
15820137|NCT04283734|Device|iFR pullback with Syncvision software (Volcano company)|iFR pullback with Syncvision software permit us to analyze the vessel completely and to predict the physiological significance of every lesion and segment, to predict the benefit of the revascularization in terms of iFR improvement, and to predict the minimum stent length necessary to achieve this improvement.
15820138|NCT04283721|Other|Educational video|Ten-minutes educational video on epidural/spinal analgesia benefits and side effects (sample video link: https://youtu.be/jAhoKhvcbP4). The informational video will be administered by co-investigators, who are anaesthesiologists. The video will be shown on an institutional iPad that will be thoroughly disinfected by the co-investigators before and after each use. Co-investigators will receive training on the disinfection process, and each disinfection will be documented on a logbook, dated and signed by the co-investigators.
15820139|NCT04283708|Procedure|Submental liposuction|Advancement Genioplasty With Submental Liposuction
15820140|NCT04283695|Drug|GX-I7 or [14C] GX-I7|IM GX-I7 or IV/IM microdose of GX-I7
15820142|NCT04283669|Drug|Crizotinib|Oral
15820143|NCT04283656|Drug|Doravirine/Lamivudine/Tenofovir|100mg/300mg/300mg orally for one dose, daily
15820150|NCT04283630|Dietary Supplement|Nature Made vitamin c 1000 mg|vitamin C and the placebo were provided as supplement capsules. Participants were asked to consume one dose/shot of sport Beet IT (70ml) that delivers on average 300-400mg of inorganic nitrate every day in the morning during the four-week study period, except for the test days and washout weeks. Accordingly, the participant were asked to consume the daily vitamin C supplement (1000 mg) or placebo one-hour post beetroot juice supplementation.
15820151|NCT04283630|Dietary Supplement|Placebo|Vitamin C matched Placebo capsules that made from starch.
15820152|NCT04283617|Behavioral|Intensification of insulin regimen/Nutrition|The intensification of the diabetes regimens will be managed by Dr. Sanchez Rangel, a fully trained attending endocrinologist, The weight goal will be to have no more than 5% weight change. Participants will have regular phone and in-person MD and nutritionist communication over the course of the 12-week study. All individuals will be asked to perform SMBG at least 4 times a day (before breakfast, lunch, dinner, and bedtime). The daily SMBG records will be sent to Dr. Sanchez Rangel weekly for review to guide adjustment of insulin regimens. Target blood glucose levels will be between 80-130 mg/dl before meals and between < 180 mg/dl at bedtime. Throughout the study, individuals will be contacted via telephone call, email or through additional clinic visits as deemed necessary for maintenance of glycemic control. All individuals will receive education regarding the detection and proper management of hypoglycemia.
15820153|NCT04283604|Drug|MPH|The treatment will include taking the patient's own medication by the patient himself in the treatment session 60-180 minutes before the beginning of the tests, according to their prescription given by their own physician. Participants must have consumed this medication at least 3 months before the first session as their regular treatment for ADHD. Note, we are not planning on giving the medication to the participant, rather he/she will consume their own prescribed MPH by them self.
15820154|NCT04283591|Procedure|Acupuncture Treatment|Acupuncture Treatment Group will get acupuncture treatment which will be applied to Baihui (DU20), Yintang (EX-HN3) points of the hemiplegic side and bilateral Tai Chong (LR3), Hegu (LI4) points for 4 weeks, twice a week.
15820155|NCT04283591|Other|Conventional Rehabilitation Programme|They will continue to receive the conventional rehabilitation programme.
15820156|NCT04283578|Drug|OT|One group will receive OT for 4 weeks, then placebo or OT for 8 weeks
15820157|NCT04283578|Drug|Placebo comparator|One group will receive Placebo for 4 weeks, then Placebo or OT for 8 weeks.
15820158|NCT04283565|Other|Systematic screening of AOMI by BPI measurement.|The strategies will be associated according to a 2*2 factorial design in order to obtain 4 arms
15820159|NCT04283565|Other|Management of CVRF by a motivationnal interviewing.|The strategies will be associated according to a 2*2 factorial design in order to obtain 4 arms
15820160|NCT04283552|Device|Dynamic PET/CT Imaging|-Will take approximately 60 minutes
15820161|NCT04283539|Drug|systemic corticosteroid or biologic|Treatment with systemic corticosteroids or biologic therapies (for corticosteroid refractory patients or these in which corticosteroids are not the treatment of choice)
15820162|NCT04283526|Drug|MBG453|Intravenous. 600mg. Every first day of a 21-day cycle, or on days 8 and 29 of a 42-day cycle (when in combination with Decitabine).
15820163|NCT04283526|Drug|NIS793|Intravenous. 2100mg. Every first day of a 21-day cycle, or on days 8 and 29 of a 42-day cycle (when in combination with Decitabine).
15820164|NCT04283526|Drug|Spartalizumab|Intravenous. 300mg. Every first day of a 21-day cycle
15820165|NCT04283526|Drug|Decitabine|Intravenous. Starting dose: 5mg/m2 (dose cap at 20mg/m2). On days 1, 2 and 3 of a 42-day cycle
15820166|NCT04283513|Drug|Virazole|Virazole (Ribavirin), USP Injection 0.1 g/mL in a phosphate buffer solution. Each vial contains 1.2 g of Ribavirin in 12 mL
15820167|NCT04283500|Drug|Buprenorphine Naloxone|Participants will receive the BUP SL 32mg in divided doses rather than all at once. If after the initial 8mg dose a participant experiences over-sedation or another adverse event that would preclude further dosing, such as an allergic reaction, the subsequent dose will not be administered and the patient will be withdrawn from the study. The participant will be reassessed for other possible etiologies for these symptoms.
15820168|NCT04283487|Dietary Supplement|Fructans|500ml 0.9% normal saline containing 40g fructans
15820169|NCT04283487|Dietary Supplement|Glucose|500ml 0.9% normal saline containing 40g glucose
15820170|NCT04283487|Dietary Supplement|Saline|500ml 0.9% normal saline
15820171|NCT04283474|Drug|XG005-03|3 different concentrations (1%, 5%, 10%) of XG005-03 topical formulation
15820172|NCT04283474|Drug|Placebo|Placebo topical formulation
15820173|NCT04283461|Biological|mRNA-1273|Lipid nanoparticle (LNP) dispersion containing an mRNA that encodes for the prefusion stabilized spike protein 2019-nCoV. mRNA-1273 consists of an mRNA Drug Substance that is manufactured into LNPs composed of the proprietary ionizable lipid, SM-102, and 3 commercially available lipids, cholesterol, DSPC, and PEG2000 DMG.
15820174|NCT04283448|Behavioral|Dietary Lentil|Participants in the Lentil arm of the study will consume midday meals containing 0.66 cups of lentils seven days per week for 12 weeks.
15820175|NCT04283448|Behavioral|Control|Participants in the Control arm of the study will consume midday meals containing 0.00 cups of lentils seven days per week for 12 weeks.
15820176|NCT04283435|Drug|Sildenafil Citrate|Sildenafil Citrate 50 mg tablets taken from the first day of the cycle till the day we start progesterone (we stop 3 days before embryo transfer)
15820177|NCT04283435|Other|Placebo|Placebo tablet (multivitamins),Pregnacare vitamins (Vitabiotics,UK)
15820178|NCT04283435|Drug|Estradiol Valerate|Estradiol valerate tablets 2mg every 8 hours daily starting from the fist day of the cycle till 12th day of the menstrual cycle.
15820179|NCT04283422|Diagnostic Test|Biofire filmarray|"Identification of microorganisms including:
~Isolation of microorganisms:
~The sample will be cultured on blood agar, chocolate agar , MacConkeys agar and Sabouraud dextrose agar (SDA) plates,
~Identification of the organism by Vitek2
~Antibiotic sensitivity test of the organism by Vitek2
~Identification of the organism by Biofire filmarray"
15820180|NCT04283409|Other|Graded activity|Exercise therapy using principles of cognitive behavioral therapy and education
15820181|NCT04283409|Other|Motor Control Exercises|Exercise therapy using principles of motor control and motor learning and education
15820182|NCT04283396|Combination Product|systemic treatment|Oxygen therapy, antiviral therapy, antibiotics, hormones, globulin
15820277|NCT04282655|Other|Control|Standard warming procedure of breast milk in syringe prior to feeding.
15820184|NCT04283370|Other|Home Rehabilitation Program|It consists in a home rehabilitation program performing electroanalgesia and an exercise program following the Mckenzie method. Patients will be instructed in the use of the TENS device using 5x9cm electrodes at the bilateral paravertebral level, the patients that present radicular pain, the electrodes will be placed in the path of the affected nerve. The realization of exercises will be through the application of an Mckezie protocol. The duration will be the same as that used to carry out the Mckenzie protocol. Mckenzie exercises are designed to make changes in the internal components periarticular of the spine.
15820185|NCT04283370|Other|e-Health program|It consists in an e-Health rehabilitation program through a web platform performing electroanalgesia and an exercise program following the Mckenzie method. Patients will be instructed in the use of the TENS device using 5x9cm electrodes at the bilateral paravertebral level, the patients that present radicular pain, the electrodes will be placed in the path of the affected nerve. The realization of exercises will be through the application of an Mckezie protocol. The duration will be the same as that used to carry out the Mckenzie protocol. Mckenzie exercises are designed to make changes in the internal components periarticular of the spine.
15820186|NCT04283357|Other|Exercise|Short Foot Exercises
15820187|NCT04283357|Device|Virtual Reality|Exercise with virtual reality
15820188|NCT04283344|Other|KY Ticket to Healthy Food Benefits|Households in the treatment group received an extra monthly SNAP benefit amount through two new intervention-related deductions to the SNAP benefit formula
15820189|NCT04283331|Drug|Proparacaine Ophthalmic|Each subject will have one eye randomized to receive a bandage contact lens soaked in anesthetic solution (proparacaine hydrochloride 0.5%) and the following eye will serve as a control and receive a bandage soft contact lens soaked in balanced salt solution, which is the current standard of care for PRK.
15820190|NCT04283318|Behavioral|12h fasting|12h fasting (overnight)
15820191|NCT04283318|Behavioral|36h fasting|36h fasting ( one day and two nights fasting)
15820192|NCT04283305|Other|Virtual reality approach avoidance training|In the VR-based AAT, patients are situated in a bar environment where drinks appear on a bar table in front of them. Patients are instructed to react to 100% of the alcoholic beverages with a push response with a controller, and to non-alcoholic drinks in 100% of the trials with a pull response. The stimuli set consists of 50 different beverages, which are displayed three times in total.
15820193|NCT04283305|Other|Computer-based approach avoidance training|In the computer-based AAT, patients are situated in front of a computer where drinks appear on the screen in front of them. Patients are instructed to react to 100% of the alcoholic beverages with a push response with a joystick, and to non-alcoholic drinks in 100% of the trials with a pull response. The stimuli set consists of 50 different beverages, which are displayed three times in total.
15820194|NCT04283292|Drug|Capsaicin|Topical Capsaicin for the treatment of Cannabinoid Hyperemesis Syndrome
15820195|NCT04283292|Drug|Placebo|Placebo cream that is applied once topically
15820196|NCT04283279|Other|Virtual reality exercise|"Participants will do exercises in a virtual environment, solving tasks that require cognitive efforts and motor/balance efforts. The virtual environment/tasks will be delivered through a head-mounted display (goggles). Difficulty will progress from standing/sitting, to walking on a treadmill. The environments that will be used will be both over-the-counter environments, as well as in-house designed environments."
15820197|NCT04283279|Other|Vestibular rehabilitation exercise|Vestibular rehabilitation exercises focus on head and eyes movements, as well as whole-body movements. The aim is to facilitate the use of other sensory organs than the vestibular organs, which will also be relevant to persons who are not receiving sufficient sensory information from the auditory system. The exercises will progress as tolerated, under careful supervision of trained therapists.
15820198|NCT04283279|Other|Control|Participants will not be randomised to either of the exercise interventions, but will be adviced to stay active
15820199|NCT04283266|Dietary Supplement|Synbiotic|Middle-aged subjects, who met ROME III criteria for constipation, received daily two sachets of synbiotic (Bifidobaterium animalis lactis Vesalius 002 and Fructo-Oligosaccharrides) for 5 days, then they received daily 1 sachet for the next 25 days
15820200|NCT04283266|Dietary Supplement|Placebo|Middle-aged subjects, who met ROME III criteria for constipation, received daily two sachets of placebo (maltodextrin and sucrose) for 5 days, then they received daily 1 sachet for the next 25 days
15820201|NCT04283253|Device|Robot + TTT exercise|The intervention will be completed 36 visits approximately 3x/week for 12-18 weeks. The training progression will be sequential with 12 visits completed on the wrist robot, followed by 12 visits on the shoulder-elbow robot and completing with 12 visits alternating sessions on the wrist and shoulder-elbow robot. Participants will perform robot training for 45 minutes with each robot followed by 15 minutes of TTT practice to complete their 60 minute intervention session.
15820202|NCT04283240|Drug|Sildenafil|50 mg sildenafil, one dose
15820203|NCT04283240|Drug|Placebo|Placebo
15820204|NCT04283227|Genetic|OTL-200|All subjects will receive OTL-200 gene therapy and will be followed up for 8 years following treatment with OTL-200.
15820205|NCT04283214|Other|Cardiopulmonary Resuscitation|Cardiopulmonary Resuscitation based on 2015 American Heart Association guidelines with and without protective equipment on traditional and endomorphic manikins
15820206|NCT04283201|Other|Physical activity|Moderate activity 150 min per week
15820207|NCT04283201|Other|Macronutrient modification|Insoluble dietary fiber 15 g per day (Vitacel wheat fiber); sugar limitation
15820208|NCT04283188|Behavioral|Dialectical behavioral therapy|Participants will be provided with the option to continue treatment with their study therapist. For those who elect to continue with DBT sessions, they will discuss frequency of sessions with their therapist, in addition to selecting type of sessions (individual and/or family skills). Participants who elect not to continue with DBT sessions at the time of enrollment will retain the option of being able to request additional sessions at any point during the 12-month study. Irrespective of participation in additional DBT sessions, all participants will be asked to complete follow-up interviews and questionnaires.
15820209|NCT04283175|Other|Posturological examination on KPlates and AMTI platforms|By an unique evaluator
15820210|NCT04283175|Other|Posturological examination on KPlates and AMTI platforms|By two evaluators
15820211|NCT04283175|Other|Berg Balance Scale (BBS)|Only for MNM and hemiparetic subjects
15820212|NCT04283162|Drug|Calcium Dobesilate|use calcium dobesilate at the dosage of 500 mg, orally, 3 times per day, for 12 months
15820216|NCT04283149|Device|EVO+ Visian ICL for Myopia|The EVO+ MICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
15820217|NCT04283149|Device|EVO+ Visian Toric ICL for Myopia with Astigmatism|The EVO+ TICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens.
15820218|NCT04283136|Drug|Padsevonil type 1 Tablet 200 mg|"Pharmaceutical form: Film-coated tablet
~Route of administration: Oral use
~Subjects will receive a padsevonil type 1 tablet in a pre-specified sequence during the Treatment Period."
15820219|NCT04283136|Drug|Padsevonil type 2 Tablet|"Pharmaceutical form: Film-coated tablet
~Route of administration: Oral use
~Subjects will receive a padsevonil type 2 tablet in a pre-specified sequence during the Treatment Period"
15820220|NCT04283136|Drug|Padsevonil type 3 Tablet|"Pharmaceutical form: Film-coated tablet
~Route of administration: Oral use
~Subjects will receive a padsevonil type 3 tablet in a pre-specified sequence during the Treatment Period."
15820221|NCT04283136|Drug|Padsevonil type 4 Tablet|"Pharmaceutical form: Film-coated tablet
~Route of administration: Oral use
~Subjects will receive a padsevonil type 4 tablet in a pre-specified sequence during the Treatment Period."
15820222|NCT04283136|Drug|Padsevonil type 5 Tablet|"Pharmaceutical form: Film-coated tablet
~Route of administration: Oral use
~Subjects will receive a padsevonil type 5 tablet in a pre-specified sequence during the Treatment Period."
15820223|NCT04283123|Behavioral|Automated Bidet|During the first intervention visit, a licensed contractor will install the bidets in participants' homes. The OT will then educate and train the caregiver and care recipient to successfully use the bidet, and make any modifications to the remote as needed. Throughout the intervention, the OT will use motivational enhancement strategies. The OT will make minor modifications to the remote as needed. A second intervention visit will occur 1-2 weeks post-installation to address any new difficulties. Check-in phone calls will be offered to the caregiver and care recipient if needed.
15820224|NCT04283123|Other|No Intervention|Waitlist control
15820225|NCT04283110|Drug|intrthecl midazolam|midazolm as as adjuvant in spinal anesthesia
15820226|NCT04283097|Drug|KPG-818|KPG-818 represents a novel generation of small molecule modulators of the CRBN E3 ubiquitin ligase complex CRL4CRBN and potently induces the ubiquitination and degradation of Aiolos (IKZF3) and Ikaros (IKZF1), two members of the Ikaros family of zinc-finger transcription factors critical in B-cell development. In preclinical studies, KPG-818 demonstrated outstanding in vitro anti-inflammatory properties and broad spectrum of anti-proliferative activities as well as remarkable in vivo efficacy in animal models of multiple blood cancers.
15820227|NCT04283084|Device|Virtual Reality Based Balance and Coordination Exercises|With the developed virtual reality based balance and coordination training system, balance and coordination exercises will be applied twice a week (12 sessions in total) for 6 weeks.
15820228|NCT04283071|Device|Boxed infrared gross kinematic assessment tool|An optical motion capture system, which records the movements of infrared emitting diodes (IREDs) in three-dimensional (3D) space by triangulating images from a pair of infrared cameras
15820229|NCT04283058|Drug|Ketamine|d. Ketamine 0.5mg/kg* dose IV in 50 mL NS will be infused at a set non-titratable rate over 40 minutes or Ketamine 1mg/kg* dose IV in 50 mL NS will be infused at a set rate non-titratable over 90 minutes. The dose that the subject will receive will be determined by the Intensive Care Unit Attending based on patient symptoms. Ketamine administered at these doses may result in the following adverse reactions such as excessive sedation or drowsiness, or unpleasant hallucinations, agitation or dysphoric reaction, nausea or increased oral secretions.
15820230|NCT04283045|Behavioral|JASPER|JASPER is a developmentally anchored behavioral intervention that assumes that communication develops from social interactions in which specific social engagement strategies, symbolic representations, and early communication forms are modeled and naturally reinforced by the adult's responses to the child. The adult referred in this condition is the TA.
15820231|NCT04283045|Behavioral|jasPEER|jasPEER is a small group intervention that aims to increase social and communication skills by using peer play as the context for learning. Two TAs will do JASPER with 2 students at the same time. Each TA will provide individualized support to their target child.
15820232|NCT04283045|Behavioral|Structured Teaching|"Structured Teaching refers to direct instruction of social communication targets of pointing to share, showing gesures, and give to share gestures, and play targets at the child's target play level.
~Structured teaching will occur at a table top with repeated trials of instruction until the child can produce the desired behavior on their own."
15820233|NCT04283032|Procedure|Multiparametric magnetic resonance|MRI uses a powerful magnetic field, pulsed radiofrequency and a computer to create detailed images of organs, soft tissues, bones, and practically the rest of the internal structures of the body. MRI does not use ionizing radiation (X-rays).
15820234|NCT04283019|Drug|CBD|CBD will be orally ingested
15820235|NCT04283019|Drug|THC|THC will be orally ingested
15820236|NCT04283006|Drug|CD20/CD22 dual Targeted CAR T-cells|Each subject receive CD20/CD22 dual Targeted CAR T-cells by intravenous infusion
15820237|NCT04282993|Device|Wearable devices for identifying and measuring risk factors for ischemic stroke|Identifying and monitoring cerebrovascular risk factors using wearable devices
15820238|NCT04282993|Other|Standard of care monitoring|Periodical medical examinations
15820239|NCT04282980|Drug|DCC-2618|Oral kinase inhibitor
15820240|NCT04282967|Behavioral|Exercise|For the first 12 weeks on study (Part 1), participants will train with an exercise physiologist for 150 minutes/week. This training will be delivered by web-based video conferencing. For the next 12 weeks (Part 2), participants will be instructed to do patient-directed exercise.
15820241|NCT04282954|Drug|JP-1366|JP-1366, QD
15820242|NCT04282954|Drug|JP-1366 placebo|JP-1366 placebo, QD
15820243|NCT04282954|Drug|Esomeprazole 40mg|Esomeprazole 40mg, QD
15820244|NCT04282954|Drug|Esomeprazole placebo|Esomeprazole placebo, QD
15820245|NCT04282941|Drug|Ibuprofen in continuous (24 hours) iv infusion and EchoG|The first dose of ibuprofen will be 10 mg / kg to be administered as a continuous infusion for 24 hours. An echocardiogram will be performed before each of the following 2 doses of 5 mg / Kg and will only be administered if it meets echocardiographic criteria that indicate open DA (observation of ductus permeability with color Doppler regardless of its size). Each dose will be administered as a 24-hour continuous infusion.
15820246|NCT04282941|Drug|IV bolus Ibuprofen slow (15 minutes) and EchoG|The first dose of ibuprofen of 10 mg / Kg to be administered in slow iv bolus (15 minutes). Before each of the following 2 doses of 5 mg / Kg, echocardiography will be performed and will only be administered if it meets the echocardiographic criteria indicated by open DA (observation of ductus permeability in color Doppler regardless of its size). Each dose will be administered in iv boluses in 15 minutes
15820247|NCT04282928|Biological|Human umbilical cord mesenchymal stem cells|Definitive Human umbilical cord mesenchymal stem cells selected by immunomodulatory assay through coculture with BV2 cell
15820248|NCT04282928|Procedure|Routine treatment|"According toInfluenza diagnosis and treatment plan (2019 version)"
15820249|NCT04282915|Other|Reducing Stigma among Healthcare Providers (RESHAPE)|Mental health service users are trained using Photo Voice to develop recovery story testimonials. They then participate in primary care providers mental health Gap Action Programme training. In addition, aspirational figures are trained to provider testimonials and conduct myth-busting.
15820250|NCT04282915|Other|mental health Gap Action Programme|The mental health Gap Action Programme is a training program for primary care providers in mental health services. The curriculum has been developed by the World Health Organization and was adapted in Nepal and certified by the Ministry of Health.
15820251|NCT04282902|Drug|pirfenidone|Pirfenidone is administered orally 3 times a day, 2 tablets each time, for a period of 4 weeks or longer
15820252|NCT04282876|Drug|Degarelix|Patients receiving Degarelix
15820253|NCT04282863|Procedure|RM|All patients were positioned in a lithotomy position. A uterine manipulator and a Foley catheter were inserted. Four trocars were used after pneumoperitoneum was obtained. Trocar sites varied according to different procedures. Generally, umbilical site for the scope and 8-10 cm lateral to the scope at 15 degrees for the arms are the most commonly adopted sites for robotic myomectomy.
15820254|NCT04282863|Procedure|LM|All patients were positioned in a lithotomy position. A uterine manipulator and a Foley catheter were inserted. Four trocars were used after pneumoperitoneum was obtained: a 10 mm port is inserted through the umbilicus to introduce the video-laparoscopic system. Other three accessory 5 mm trocar are inserted into the abdomen to the left lower quadrant, right lower quadrant, suprapubic area, for operative instruments and the suction irrigator cannula.
15820255|NCT04282850|Procedure|Pulmonary Vein Isolation|The intervention will involve standard of care electrophysiology ablation for rhythm management of atrial fibrillation with a procedure called a pulmonary vein isolation.
15820256|NCT04282837|Diagnostic Test|AI classification of patients with obesity|Computational modeling techniques will be used for the precise reclassification of obesity into four subgroups, several variables according to the clinical experience and the modeling results will be selected for the cluster analysis.
15820257|NCT04282824|Procedure|Biospecimen Collection|Undergo collection of saliva
15820258|NCT04282824|Procedure|Computed Tomography|Undergo PET/CT
15820259|NCT04282824|Drug|Gallium Ga 68-labeled PSMA-11|Given IV
15820260|NCT04282824|Dietary Supplement|Monosodium Glutamate|Given PO
15820261|NCT04282824|Procedure|Positron Emission Tomography|Undergo PET/CT
15820262|NCT04282811|Drug|Venetoclax|Patients treated with venetoclax-based regimens outside clinical trials in Italy
15820263|NCT04282798|Other|Personalized Music Intervention|Participants will complete a series of questionnaires to identify participants' music preferences and participants' sensitivity to reward from musical engagement. The responses from the music preference questionnaires will be used to create a 1 hr playlist of songs by a member of the study team for the participant to be played daily for four weeks. After playlist is created and transmitted to MP3 device, participants will pick up the equipment and a compliance log will be given for the participant and participants' caregivers to confirm adherence to the protocol of daily listening. The platform will be Spotify, where the MP3 device given to participant at the start of the intervention will be preprogrammed with the participant's personal playlist on the platform. This trial is a supplementary treatment option for cognitive and neuropsychiatric assessments for AD, as such no alterations in the current treatment plans of any participant will be necessary.
15820264|NCT04282785|Diagnostic Test|Concentration monitoring of antibiotics in plasma|Plasma antibiotic concentration will be measured using a bedside method with UV-VIS spectroscopy. These measurements will be validated with golden standard that is HPLC-MS.
15820265|NCT04282772|Diagnostic Test|Impacted|Until an active treatment for the PFM is started or the early exfoliation of PSM occurs, the tooth remains in a self-locking position
15820266|NCT04282772|Diagnostic Test|Self-corrected|The ectopic erupted permanent molar can disregard the self-locking position and continue in a normal direction, but the distal root of the PSM remains more or less a significant atypical resorption
15820267|NCT04282746|Drug|JNJ-54135419|Single dose of JNJ-54135419 oral solution will be administered sublingually.
15820268|NCT04282733|Behavioral|Mindfulness Rounds|"Throughout the 8-week study period, a different mindfulness practice will be introduced weekly in 3 separate 15-minute live sessions. Posters describing the particular practice of the week will be placed around the Unit as visual reminders to encourage actual practice."
15820269|NCT04282720|Device|SurgiMend Mesh|Following placement of SurgiMend mesh during laparoscopic hiatal hernia repair, patient will be scheduled for follow up using an upper GI series to check for recurrence of the hiatal hernia. Follow up upper GIs will be performed at 6 months post-surgery. Subjects will also complete a QOL survey to assess other GI associated symptoms before and after surgical repair. The QOL survey can be administered by phone by study team members
15820270|NCT04282707|Procedure|Endoscopic closure of ESD defect|Closure of ESD defect would be performed with clip loop purse string technique
15820271|NCT04282707|Other|Gastric ESD without closure of ESD defect|Historical control with patients undergoing ESD without closure of ESD defect
15820272|NCT04282694|Diagnostic Test|Low-dose computed tomography (LDCT)|Early detection of lung cancer by LDCT and smoking cessation counselling
15820273|NCT04282681|Other|Accelerometer Live-Streaming Tool|The only 'intervention' that will take place is the placement of the XLS tool(s) on the upper left chest and/or left wrist of the patient.
15820274|NCT04282668|Drug|TAS1440|Form: Capsule Route of Administration: Oral
15820275|NCT04282668|Drug|TAS1440 + ATRA|Form: Capsule Route of Administration: Oral
15820276|NCT04282655|Other|Treatment Guardian Milk Warmer (Medela TM)|Infants were randomized to receive prepared syringes of breast milk via the continuous milk warmer (treatment arm)
15820279|NCT04282642|Behavioral|WLC (Waitlist Control)|Participants (n=20) will receive the cognitive training intervention later, following week 8 assessments.
15820280|NCT04282629|Drug|Milrinone Injection|administration of milrinone (0.75 μg / kg / min, intravenous) from Day 4 to Day 14
15820281|NCT04282629|Other|Placebo|administration of placebo (intravenous glucose 5%) from Day 4 to Day 14
15820282|NCT04282616|Other|Home-based unstructured physical activity program|Counselling on physical activity according to American College of Sports Medicine guidelines
15820283|NCT04282616|Other|Home-based structured low-intensity physical activity program|Structured home-based low-intensity intermittent walking program
15820284|NCT04282616|Other|In-hospital structured supervised physical activity program|Supervised exercise training program
15820285|NCT04282603|Combination Product|Weight Loss and Weight Maintenance|Participants will consume a 1,200 kcal/day diet for twelve weeks. This is the amount of calories most commonly provided in medical weight loss programs, and considered the maximum allowable caloric intake to induce a physiologically significant weight loss. Following the weight loss portion of the trial, participants will enter the twelve week maintenance period, during which time they will consume one serving per day in place of lunch of the same meal replacement beverage used during medical weight loss.
15820286|NCT04282590|Drug|TRK-750/Placebo|Powder for oral solution
15820287|NCT04282590|Drug|Placebo/TRK-750|Powder for oral solution
15820288|NCT04282577|Diagnostic Test|urinary nephrin and alpha one microglobulin|urinary nephrin and alpha one microglobulin are biomarkers of glomerular filtration barrier injury and tubular injury respectively measured by ELISA
15820289|NCT04282564|Other|Co-OP treatment|"The Cognitive Orientation to daily Occupational Performance (CO-OP) approach is described as a patient-centred, performance-oriented approach to activities and problem solving that allows skills to be acquired through a process of strategy use and guided discovery. The CO-OP protocol is composed of seven key characteristics: i) the goals chosen by the patient, ii) dynamic performance analysis, iii) the use of cognitive strategies, iv) guided discovery, v) the principles of empowerment, vi) the involvement of a relative, vii) the structure of the intervention (Polatajko and Mandich, 2004/2017). CO-OP is an evidence-based approach to intervention, including evidence of its effectiveness on a physical, cognitive and emotional dimension in adults with stroke"
15820290|NCT04282551|Other|dietary intervention with oligosaccharides|intervention with oligosaccharide 1 or 2, or placebo, given once a day
15820291|NCT04282538|Device|Active rTMS|4-week (5 days per week) active rTMS (90%rMT, M1, 10Hz for 10s, 50s interval, 20 trains)
15820292|NCT04282538|Device|Sham rTMS|4-week (5 days per week) sham rTMS
15820293|NCT04282538|Device|Active tDCS|4-week (5 days per week) active tDCS (2mA, DLPFC, 20 min)
15820294|NCT04282538|Device|Sham tDCS|4-week (5 days per week) sham tDCS
15820295|NCT04282538|Other|Walking training|4-week (5 days per week) walking training
15820296|NCT04282538|Other|Cognition training|4-week (5 days per week) cognition training
15820297|NCT04282525|Other|ECMO for hemodynamic or respiratory indication|ECMO for hemodynamic or respiratory indication
15820298|NCT04282512|Other|Sodium bicarbonate-rich mineral water|St-Yorre, a sodium bicarbonate-rich mineral water, is a commercial mineral water that contains 4368 mg/l sodium bicarbonate. The study intends to evaluate the effect on blood pressure of the sodium bicarbonate intake due to this mineral water consumption.
15820299|NCT04282499|Procedure|combined exercise|Patients will be undergone to aerobic exercises in addition to the resistance training.
15820300|NCT04282499|Procedure|aerobic exercise|Patients will be trained through the aerobic exercises only.
15820301|NCT04282486|Other|Telephone interview|"Primary objective: potentially inappropriate medication prevalence
~Secondary objective:
~Number and type of medication Polypharmacy prevalence Medication regimen complexity using Medication Regimen Complexity Index Anticholinergic and sedative exposure using Drug Burden Index
~A telephone interview will be conducted with patients in order to collect medication data from medical prescriptions."
15820302|NCT04282460|Behavioral|Baduanjin practice|Use the Baduanjin training system to practice the whole set of Baduanjin at least once a day and at least 5 days each week for 3 months.
15820303|NCT04282460|Behavioral|Regular physical exercise|Take physical exercise for at least half an hour every day in addition to regular physical activities at school.
15820304|NCT04282408|Device|Scoliosis back brace|The patients will use the traditional brace, if not already in use, for 2 weeks and then they will wear a 3D printed back brace for the following 2 weeks. Both the braces will be worn for the amount of hours per day prescribed by the physician.
15820305|NCT04282395|Behavioral|Resilience-Based Diabetes Self-Management Education|"During the group sessions led by professional nurses, participants are provided information and group activities to enable them to more effectively manage their personal diabetes challenges. During the support group sessions, participants discuss personal challenges and solutions to diabetes self-management, using a more informal approach. Booster sessions are held to refresh participants' understanding of how resilience resources can sustain self-management behaviors and maintain improved T2DM health outcomes. The RB-DSME also incorporates cultural characteristics and preferences of African Americans (AAs), to include:
~the location in community-based church settings,
~recognition of cultural dietary preferences, and
~emphasis on cultural/historical significance of resilience in AAs."
15820306|NCT04282395|Behavioral|Standard Diabetes Self-Management Education|"Control group sessions, led by professional nurses, cover topics such as:
~causes and symptoms of type 2 diabetes,
~glucose self-monitoring,
~models for and principles of healthy eating, grocery shopping and dining out,
~physical activity,
~diabetes medications,
~managing sick days and stress, and
~community resources."
15820307|NCT04282369|Device|HHHFNC|noninvasive ventilation modality
15820308|NCT04282369|Device|NCPAP|noninvasive ventilation modality
15820309|NCT04282369|Device|NIPPV|noninvasive ventilation modality
15820310|NCT04282369|Device|NHFO|noninvasive ventilation modality
15820311|NCT04282356|Drug|Intraperitoneal chemotherapy during surgery|During interval surgery the patient will undergo HIPEC (Cisplatin 100mg/m2, 1h 30 infusions with sodium thiosulfate renal protection). They will then receive postoperative IPC i.e intravenous and intraperitoneal administration (IV Paclitaxel, 135mg/m2 on D1, IP Carboplatin, AUC 6 on D1, and IP Paclitaxel, 60mg/m2 on D8) with at least 3 courses performed (up to 4-6 allowed).
15820433|NCT04281394|Other|conventional gait training|even level gait training and range of motion exercises
15820312|NCT04282343|Behavioral|The DISCO App|Patients will receive an individually-tailorable cancer treatment cost education and communication intervention delivered on an iPad just prior to meeting with their oncologist.
15820313|NCT04282343|Behavioral|Usual Care|Patients randomized to this arm will receive usual care.
15820314|NCT04282330|Diagnostic Test|3D CEST imaging|Chemical Exchange Saturation Transfer (CEST) is an emerging MRI technique that can acquire multiple endogenous contrasts to probe cerebral metabolism.
15820315|NCT04282317|Other|MRI scan|MRI scan
15820316|NCT04282304|Behavioral|Preoperative usual care|"Usual care during the preoperative preparation for bariatric surgery consists of:
~Endocrinologist work-up and follow-up, with at least 2 consultations;
~Dietary advice, provided during the endocrine consultation or dietician consultation
~Psychological counselling with the patient's usual psychiatrist (at least 2 consultations
~Physical activity and nutrition are encouraged, but entrusted to the patient's freedom of choice. Weight loss, or at least, weight stabilization, is recommended before the surgery, without initiating a specific behavioural procedure."
15820317|NCT04282304|Behavioral|Preoperative intensive behavioral lifestyle intervention|"The intensive behavioral lifestyle intervention program takes place over 4 weeks of 5 days. It includes:
~Rehabilitation to physical exercise every morning
~Therapeutic cooking sessions; during these sessions, the patients prepare the day's meals under the supervision of a nutritionist
~Psychological counselling
~One swimming session per week
~One relaxation session
~Regular physical activity (aerobics, work-up)
~Individual entertainment with the physiotherapist physician and discussion groups
~Weight, BMI and waist circumference control at the end of each week."
15820318|NCT04282291|Procedure|fascial block as postoperative analgesia|The tissue damage induced by the surgery generates a nociceptive pain which is accompanied by inflammatory mechanism (somatic pain), visceral and neuropathic pain, and why the treatment must be adapted to each surgical procedure. As the innervation of the upper abdominal wall depends mainly on the last intercostal nerves, the block of these nerves should be considered a good analgesic strategy to avoid the somatic pain. The placement of the local anesthetic in the serratus intercostal plane at the eighth rib (serratus intercostal plane block, SIPB) in the middle axillary line, managed to block the lateral and anterior cutaneous branches of the last intercostal nerves (T7-11). The results were satisfactory in the postoperative pain control of the patients with open cholecystectomy.
15820319|NCT04282291|Drug|Morphine|The continuous (basal) dose
15820320|NCT04282291|Device|PCA CADD Smith Medical pumps|perfusion
15820321|NCT04282278|Drug|Camrelizumab/sintilimab+ Standard chemotherapy|Camrelizumab/sintilimab：200mg，iv，30min，d4，q3w，24 months Standard chemotherapy：Researcher chooses standard treatment by recommended guidelines，d 1-3
15820322|NCT04282278|Drug|Camrelizumab/sintilimab+ apatinib（Intolerance to chemotherapy / refuse chemotherapy）|Camrelizumab/sintilimab：200mg，iv，30min，d4，q3w，24 months Apatinib：250mg，d1，qd，po
15820323|NCT04282278|Drug|Camrelizumab/sintilimab+ apatinib+ Standard chemotherapy|Camrelizumab/sintilimab：200mg，iv，30min，d7，q3w，24 months Apatinib：250mg，d1，qd，po Standard chemotherapy：Researcher chooses standard treatment by recommended guidelines，d 1-3
15820324|NCT04282265|Dietary Supplement|Placebo|Oral placebo capsules will be taken consisting of maltodrextrin daily for 11 weeks
15820325|NCT04282265|Dietary Supplement|Red Spinach Extract (RSE)|Oral capsules containing 2g of Red Spinach Extract will be consumed daily for 11 weeks
15820326|NCT04282252|Drug|I.V. SOLUTIONS|All i.v. fluids used in an Intensive Care Unit.
15820327|NCT04282239|Procedure|PECS2 block|Superficial peripheral nerve block placed at the interfascial plane between the pectoralis major and minor muscles and the plane between the pectoralis minor and serrates anterior muscles. Targeted nerves include the lateral and medial pectoral nerves in addition to the long thoracic nerve, thoracodorsal, and thoracic intercostal nerves from T2 to T6.
15820328|NCT04282239|Drug|Ropivacaine 0.5% Injectable Solution|15 mL on each side of anterior chest for a total of 30mL
15820329|NCT04282239|Drug|Lidocaine Epinephrine|10 mL on each side of anterior chest for a total of 20mL
15820330|NCT04282239|Drug|Dexmedetomidine 0.004 MG/ML|10 mL
15820331|NCT04282226|Device|active transcutaneous Vagal Nerve Stimulation (tVNS)|The tVNS device will be attached to the left aspect of the neck to stimulate the cervical branch of the vagal nerve and connected to an MR safe electrical stimulator.
15820332|NCT04282226|Device|sham transcutaneous Vagal Nerve Stimulation (tVNS)|The tVNS device will be attached to anatomically distinct from the cervical branch of the vagal nerve.
15820333|NCT04282200|Drug|Ketorolac|intravenous ketorolac 30 mg every 6 hours
15820334|NCT04282187|Drug|Decitabine|Given IV
15820335|NCT04282187|Drug|Ruxolitinib|Given PO
15820336|NCT04282187|Drug|Fedratinib|Given PO
15820337|NCT04282187|Other|Questionnaire Administration|Ancillary studies
15820338|NCT04282174|Device|CliniMACS|allogeneic Human leukocyte antigen-compatible related or unrelated transplants of GCSF-mobilized peripheral blood stem cells depleted of T-cells by positive selection of CD34+ progenitor cells using the CliniMACS system
15820339|NCT04282174|Procedure|Bone Marrow Transplant|Bone Marrow Transplant will come from either an HLA matched related sibling or HLA un-related donor
15820340|NCT04282174|Drug|Hyperfractionated Total Body Irradiation|Hyperfractionated Total Body Irradiation is administered at a dose rate of < 20 cGy/minute. Doses of 125 cGy/fraction are administered at a minimum interval of 4 hours between fractions, three times/day for a total of 11 or 12 doses (1375 or 1500 cGy) over 4 days (Day -9, -8, -7 and -6).
15820341|NCT04282174|Drug|Thiotepa|Thiotepa: 5mg/kg/day IV over approximately 4 hr. daily x 2 (Day -5 and Day -4). If scheduling of transplant harvests requires, the dose of Thiotepa may be administered as a single dose of 10mg/kg/day x 1.
15820342|NCT04282174|Drug|Cyclophosphamide|Cyclophosphamide: 60 mg/kg/day I V over approximately 30 min daily x 2 days (d -3 and -2). Cyclophosphamide dosing will be adjusted if patient is > 125% of ideal body w eight and will be calculated based on adjusted ideal body weight, as per MCI standard of care guidelines.
15820343|NCT04282174|Drug|Busulfan|0.8 mg/kg every 6 hours x 10 or 12 doses), (depending on disease) with dose modified
15820344|NCT04282174|Drug|Melphalan|Melphalan 70mg/m2/day x 2 days IV over 30 minutes. Dose should be adjusted if patient is > 125% ideal body weight and should be calculated on adjusted ideal body weight per MCI standard of care guidelines. Melphalan will be administered on Days - 7 and -6 for multiple myeloma patients.
15820345|NCT04282174|Drug|Fludarabine|"Fludarabine 25mg/m2/days x 5 days IV over 30 minutes. Fludarabine may be adjusted in the case of renal toxicity.
~In select cases in which the peripheral blood stem cells must be harvested a day later than requested due to a scheduling issue with the donor or Stem Cell Processing Laboratory."
15820346|NCT04282161|Device|Axys EX device|Rotational atherectomy system for endovascular treatment of peripheral arterial disease prior to adjunctive therapy, if needed
15820347|NCT04282148|Device|ABT NG DES 48 EECSS|Each participant will receive ABT NG DES 48 EECSS with appropriate diameter
15820348|NCT04282135|Diagnostic Test|MCC IMS|Diagnosis by MCC IMS
15820349|NCT04282122|Radiation|Radiotherapy|curative-intent radiotherapy
15820350|NCT04282109|Drug|Nivolumab + Paclitaxel|"Combination treatment: Nivolumab 240 mg will be administered via IV infusion every 2 weeks. Paclitaxel 80mg/m2 will be administered via IV infusion weekly. After 12 weeks from the start of the combined treatment paclitaxel will be stopped.
~Maintenance treatment with nivolumab 480 mg every 4 weeks will start two weeks after the last administration of nivolumab 240 mg. Once nivolumab is administered at 480 mg, paclitaxel can no longer be administered.
~Nivolumab will be continued alone until disease progression, unacceptable toxicity or withdrawal of consent up to a maximum of 24 months."
15820351|NCT04282109|Drug|Cetuximab + Paclitaxel|"Combination treatment: Cetuximab 250 mg/m2 (first dose of 400 mg/m2) administered via IV infusion weekly plus weekly paclitaxel (80 mg/m2) administered via IV infusion.
~After 12 weeks from the start of the combined treatment paclitaxel will be stopped and weekly cetuximab will be continued alone until disease progression, unacceptable toxicity or withdrawal of consent up to a maximum of 24 months."
15820352|NCT04282096|Other|native and non native casein|selected participant will test the 3 treatments in a random order
15820353|NCT04282070|Drug|SHR-1701|Subjects will receive an intravenous infusion of SHR-1701 until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.
15820354|NCT04282070|Drug|Gemcitabine|Maximum 6 cycles for combined therapy.
15820355|NCT04282070|Drug|Cisplatin|Maximum 6 cycles for combined therapy.
15820356|NCT04282070|Drug|Albumin Paclitaxel|Maximum 6 cycles for combined therapy.
15820357|NCT04282057|Device|Radiofrequency|Radiofrequency protocol - The radiofrequency protocol was performed in dorsal decubitus, with the head elevated at 45 degrees. The application was in capacitive mode, with a 7cm electrode, always in movement. The duration of the application was established in 15 minutes, maintaining the local temperature between 40 to 42 celsius degrees at the epidermis.
15820358|NCT04282057|Device|Aerobic exercise|Aerobic exercise protocol - 40 minutes of aerobic moderate-intensity exercise (45-55% of reserve heart rate) using Karvonen's formula, performed on a cycloergometer. The duration of the exercise was divided into three parts: warm-up (5 minutes); body (30 minutes); and cooling (from 5 to 10 minutes). The entire protocol was monitored through the Polar® brand heart rate monitor and watch.
15820359|NCT04282057|Device|Shock wave therapy|The shock wave device corresponds to the BTL-6000 X-Wave TM with a 20mm transmitter multifocal. The parameters used correspond to the pressure set between 2.8 and 3.5 bar, frequency 15 hertz and 3000 pulses per 10x15 cm area. It was used as a means contact gel for ultrasound, reference 033-051. In this procedure the participants found themselves in the supine position, with a pillow under the head and with the bending knees.
15820360|NCT04282044|Biological|CRX100 suspension for infusion|A fixed dose of CIK cells combined with the specified dose of CDSR.
15820361|NCT04282031|Drug|BPI-1178|BPI-1178 once daily on Days 1 to 21 of a 28-day cycle
15820362|NCT04282031|Drug|Fulvestrant|Fulvestrant 500mg intramuscularly on Days 1 and 15 of Cycle 1, and on Day 1 of Cycle 2 and beyond
15820363|NCT04282031|Drug|Letrozole|Letrozole 2.5 mg once daily of a 28-day cycle
15820364|NCT04282018|Drug|BGB-10188|Administered as specified in the treatment arm
15820365|NCT04282018|Drug|Zanubrutinib|Administered as specified in the treatment arm
15820366|NCT04282018|Drug|Tislelizumab|Administered as specified in the treatment arm
15820367|NCT04282005|Procedure|Metabolic/Bariatric surgery|Patients will undergo surgery; 7 RYGB and 7 SG, as planned for their standard care.
15820368|NCT04282005|Other|Lifestyle and Diet|Patients will be provided with a lifestyle interventions including dietary counselling choosing between a Low-Calorie Diet or a Meal Replacement Diet.
15820369|NCT04281992|Biological|AUP1602-C|AUP1602-C is topically applied on chronic wounds and covered by wound dressing.
15820370|NCT04281979|Drug|Study Agent|The study agent will be administered via beverages and/or a capsule. The substances used in the study are legal, non-prescription, and are proven safe for human consumption at the doses used. The study agent may be a depressant (such as alcohol), a stimulant (such as caffeine), or an analgesic (such as aspirin).
15820371|NCT04281979|Drug|Placebo|In the placebo conditions participants will consume beverages and capsules that contain no or very small quantities of the study agent.
15820372|NCT04281966|Behavioral|Ability School Engagement Program Conference|"The ASEP conference focuses on understanding the reasons behind why the young person is not attending school regularly, understand how the young person's non-attendance affects other conference participants, highlight the legal consequences of parents and/or guardians to ensure that their child attends school, and the development of a young person-centered Action Plan, which will specifically detail the actions that all parties are to take over the next three months to ensure that the young person re-engages with school and/or transitions into paid work."
15820373|NCT04281953|Diagnostic Test|High frequency audiometry|Simple hearing test
15820374|NCT04281953|Other|Short-Form 36-Item Questionnaire (SF-36)|Questionnaire on quality of life (Short Form 36 Item- SF-36)
15820375|NCT04281953|Other|Hearing handicap inventory for adults/elderly (HHIA/HHIE)|Questionnaire on Hearing loss (Hearing handicap inventory for adults/elderly- HHIA/HHIE)
15820376|NCT04281953|Other|Tinnitus handicap inventory (THI)|Questionnaire on Tinnitus (Tinnitus Handicap Inventory)
15820377|NCT04281927|Device|Monitoring with wearable (the tested device) and Holter ECG (eMotion Faros 90)|Participants will use the wearable (the tested device) to record at least 2 minutes of photoplethysmography and 6-lead ECG. In addition, each subject will be monitored with synchronous ECG Holter monitoring (with eMotion Faros 90).
15820378|NCT04281901|Drug|Platelet- and extracellular vesicle-rich plasma|ear wick soaked in platelet- and extracellular vesicle-rich plasma
15820507|NCT04280718|Biological|Efgartigimod PH20 SC|Subcutaneous administration of efgartigimod
15820379|NCT04281901|Drug|Standard conservative treatment|standard conservative measures, including antimicrobials, antiseptics and aural toilette for treating a chronically inflamed radical cavity.
15820380|NCT04281875|Device|NIRAF Detection Technology|"Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device).
~After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio > 1.2 is interpreted by device as the suspect tissue being positive for parathyroid."
15820381|NCT04281862|Drug|Dextenza 0.4Mg Ophthalmic Insert|The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration.
15820382|NCT04281862|Drug|Topical Prednisolone|Standard of care topical drop treatment
15820383|NCT04281849|Behavioral|BAMS-HF Program|"BAMS-HF Program (intervention) arm will consist of 3 in-home sessions (45-60 min ea) per week for 12 weeks with the study physical therapist. The study physical therapist will transition appropriate participants to virtual in-home visits (i.e. telerehabilitation) for some visits. The study physical therapist will design individualized exercise programs first targeting strength, then mobility and balance, and finally, aerobic capacity. Exercises will be progressive, with the goal of an 8 repetition maximum for each strength component, 80% completion rate for balance/mobility components and targeting a moderate rate of perceived exertion for aerobic components.
~Interviews: There will be a recorded interview after the last session of the study to get participants' opinion of the program, suggestions for improvement and description of any barriers to participating in the program fully."
15820384|NCT04281836|Behavioral|Interoceptive breathing awareness through use of audio and visual virtual technology aid|Participants are asked to focus on their breathing while (a) listening to their breathing sounds with headphones and (b) watching the 3-D image of their lungs inhaling and exhaling in real-time using the Oculus Rift 3D virtual imaging equipment and plethysmography belt. During this time fNIRS and tQST data will be collected (more detail provided below).
15820385|NCT04281836|Behavioral|Interoceptive breathing awareness without use of audio or visual virtual reality|Participants are asked to focus on their breathing. During this time fNIRS and tQST data will be collected (more detail provided below).
15820386|NCT04281823|Diagnostic Test|Cardiovascular Magnetic Resonance|Patients will undergo various CMR techniques designed to assess cardiovascular structure and function, tissue characteristics, and flow.
15820387|NCT04281810|Device|transcutaneous electric diaphragm stimulation|The electrodes were placed on the parasternal region beside the xiphoid process; and the sixth and seventh intercostal spaces in line with the mid-axillary line. TEDS was set as biphasic waves, frequency of 30 Hz, pulse width of 400 μs, and rise time of 0.7s.
15820388|NCT04281797|Diagnostic Test|Intestinal microbiome new generation sequencing|Fecal samples collected at baseline pre-transplant and post-transplant, new generation 16s RNA sequencing performed.
15820389|NCT04281784|Behavioral|EHR-based Clinician Jumpstart|The Jumpstart Guide is a communication-priming intervention for clinicians that addresses hospitalized patients' goals of care. The intervention's goal is to prompt clinicians to provide standard of care which includes a discussion with patients or their legal surrogate decision-maker about their goals of care. The one-page Jumpstart Guide provides information to the clinician about prior advance care planning documentation and code status derived from the EHR. The Jumpstart Guides includes tips to improve goals-of-care communication.
15820390|NCT04281771|Procedure|cardiac MRI|"Patients are studied on a clinical 1.5 Tesla scanner with cardiac radiofrequency receiver coil centered over the heart, and ECG monitoring. The following parameters are assessed:
~Functional imaging: ECG-gated cine Steady-state free precession (SSFP) MRI images are obtained during repeated breath holds in long axis and short axis orientations covering the entire left ventricle. Global systolic and diastolic function are assessed, and left ventricular mass is calculated.
~Flow imaging: ECG-gated 2D flow measurements are assessed above the prosthetic valve, and at the level of the pulmonary trunk."
15820391|NCT04281758|Other|Beverage|16 oz (473.2 ml)
15820392|NCT04281745|Biological|CORETOX Inj|Clostridium botulinum type A (Hall group); a lyophilized white power for injection with a colorless transparent vial. colorless transparent solution when dissolved with saline.
15820393|NCT04281732|Device|Virtual Reality Headset based tests|Visual task tests based on Oculus Rift
15820394|NCT04281719|Other|Mobile Application (working name: Bright Path)|The Bright Path web-based mobile application is designed to target co-occurring problems, enhance patient treatment engagement, and contribute to lasting improvements in teens' mental health. The central hypothesis is that developmentally tailored mobile applications that incorporate evidence-based treatment principles can facilitate increased patient engagement in and between sessions, thus, improving the efficiency, efficacy, and reach of treatments for this highly vulnerable population.
15820395|NCT04281706|Drug|Etomidate vs Propofol as induction agent|Patients undergoing cardiac surgery were induced with Etomidate according to the standard operating procedure for induction until October 1st, 2013, afterwards a new SOP with Propofol as primary induction agent was introduced. After a washout period of 3 months, Propofol was used as sole induction agent. The rest of the standard operating procedure remained the same.
15820396|NCT04281693|Diagnostic Test|Standard screening strategy|The pharyngeal swab specimen was obtained and sent for NCIP RNA detection by individual testing.
15820397|NCT04281693|Diagnostic Test|New screening strategy|The pharyngeal swab specimen was obtained and sent for NCIP RNA detection by minipool testing.
15820398|NCT04281680|Drug|Pasireotide 0.9 MG/ML|900-ug pasireotide administered subcutaneously twice daily for a week or until discharged from the hospital
15820399|NCT04281667|Drug|Oral Antibiotics|Oral antibiotics (neomycin 1g and metronidazole 1g at 3pm and 11pm the day before surgery)
15820400|NCT04281667|Drug|Placebo|Oral placebos (placebo 1 and placebo 2 at 3pm and 11pm the day before surgery)
15820401|NCT04281667|Drug|Mechanical Bowel Preparation|Mechanical Bowel Preparation using 2L polyethylene glycol (Moviprep)
15820402|NCT04281654|Other|Active Social Conversation|Active Social Conversation
15820403|NCT04281641|Diagnostic Test|TCHP|"Drug: Trastuzumab 8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV Other Name: Herceptin
~Drug: Pertuzumab 840 mg as a loading dose, then 420 mg every 3 weeks, IV Other Name: Perjeta
~Drug: carboplatin at target area under the plasma concentration-time curve (AUC) 6
~Drug: docetaxel at a starting dose of 75 mg/m2 then to 60mg/m2 (q3w).
~All study drugs were administered intravenously.
~Procedure: 18-FDG-PET and 68 Ga-Affibody HER-2 Imaging PET will be performed at baseline, on day 15 and before surgery
~Genomic alterations (mutations/somatic rearrangements) are detected at baseline, on day 15 and before surgery."
15820404|NCT04281628|Drug|Ketamine group:|Ketamine group: will be administered ketamine in a loading dose of 0.2 mg/kg over 5 min pre incision followed-by an infusion at 0.2 mg/kg/h until the end of surgery.
15820405|NCT04281628|Drug|Control group|where normal saline was administered as a loading dose then infused with same rate of another group, throughout the whole surgery.
15820406|NCT04281615|Other|Generic Message|Exposed to four sets of promotional materials hypothesized to increase perceptions of self-efficacy to meet Guidelines.
15820407|NCT04281589|Other|if the ventilation parameter caused desaturation or hypercapnia we will change the parameter|we will increased fi02
15820408|NCT04281576|Device|NovoTTF-100L(P)|Patients receive continuous TTFields treatment using the NovoTTF-100L(P) device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the abdomen. The treatment enables the patient to maintain regular daily routine.
15820409|NCT04281576|Drug|Oxaliplatin|Oxaliplatin 130 mg/m^2 intravenous infusion will be administered once every 3 weeks
15820410|NCT04281576|Drug|Capecitabine|Capecitabine 1000mg/m^2 taken by mouth, twice daily on day 1-14, 3 weeks per cycle
15820411|NCT04281576|Drug|Trastuzumab|Trastuzumab (HER-2 positive patients only) intravenous infusion will be administered once every 3 weeks on Day 1 of each cycle. First dose is 8mg/kg, followed by 6 mg/kg.
15820412|NCT04281563|Other|massage with MCT oil (group 1)|Two trained nurse took turns performing standardized massage techniques in group 1 and group 2. The difference was that in group 1, the neonates received massage with MCT oil, and in group 2, the neonates received massage without using the oil. The 10-min massage intervention consisted of two 5-min phases: tactile and kinesthetic stimulation (13), which were given three times a day for 7 consecutive days. The massage force was approximately 300 grams, and the massager practiced applying the pressure by using a food scale. The massage was given in the prone and supine positions, and the actions included gentle touching of the head, back and limbs for five 1-min periods, followed by six passive flexion/extension movements lasting 10 s apiece for each arm, then each leg, and finally both legs together for a total of five 1-min periods. Premature infants in the oil massage group received massage with 10 mL/kg/day of MCT oil divided equally into three applications.
15820413|NCT04281550|Other|Think Drink|The Think Drink Guide that had three interacting components. The 'policy' component was directed at the governance of the care home, whereas 'practice' components were directed at hydration procedures and processes, and 'educational' components that provided learning resources for care home staff to develop knowledge and understanding of hydration care. Think Drink was implemented through a short awareness-raising educational programme and accompanying information booklet detailing a range of practices (including organisational, system and individual practice) designed to encourage hydration.
15820414|NCT04281537|Drug|Agalsidase Beta|Enzyme Replacement Therapy - Infusion every other week
15820415|NCT04281537|Drug|Agalsidase Alpha|Enzyme Replacement Therapy - Infusion every other week
15820416|NCT04281524|Drug|CSL312|CSL312 administered as an IV infusion
15820417|NCT04281524|Drug|Placebo|Solution of 70% 0.9% saline / 30% CSL312 diluent
15820418|NCT04281498|Drug|Ruxolitinib|Patients who are on ruxolitinib will continue their current dose. Patients who are not on ruxolitinib will receive ruxolitinib dosing based on platelet count
15820419|NCT04281498|Drug|Enasidenib|50mg -100mg daily
15820424|NCT04281472|Biological|efgartigimod PH20 SC in stage B|Stage A: efgartigimod PH20 SC, Stage B: efgartigimod PH20 SC
15820425|NCT04281472|Other|placebo in stage B|Stage A: N/A, stage B: placebo
15820426|NCT04281459|Other|HIV Treatment Satisfaction Questionnaire status|Administration of pseudoanonymous HIV-TSQs (translated into Italian) to all included patients.
15820427|NCT04281446|Device|Photobiomodulation|Application of light at specific wavelength for interaction with biological tissue
15820428|NCT04281433|Other|Activa Bioactive|Before cavity preparation and restoration, masticatory muscles activity will be evaluated by using electromyography. An electromyography detects the electrical potential generated by muscle cells. A total of 40 posterior teeth will be selected for this study and grouped into 2 main groups (20 for each group)) according to presence of caries in one or both side in patient (unilateral or bilateral). Split mouth technique will be used. The affected teeth will be treated by removing the caries and restored tooth with bulk fill composite material, after restoring the affected teeth. Masticatory muscles activity will be evaluated by using electromyography to detect any changes in masticatory muscles activity before and after restoration.
15820429|NCT04281420|Drug|ATG-019|ATG-019 30 mg QoD×3 is selected as the staring dose. Oral ATG-019 will be taken three times a week every other day (Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26) during each 28-day cycle.
15820430|NCT04281420|Combination Product|ATG-019 + Niacin ER|ATG-019 60 mg is selected as starting dose. Oral ATG-019 will be taken three times a week every other day (Days 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, and 26) during each 28-day cycle. And a starting dose of 500 mg niacin ER (may be titrated up to 1,000 mg of daily dose, per label) co-administered with each dose of ATG-019.
15820431|NCT04281407|Dietary Supplement|Visbiome|2 capsules of Visbiome, a probiotics supplement, twice a day (morning and evening) for 28 days
15820432|NCT04281394|Device|Robot assisted gait training|SUBAR® (CRETEM, Korea) is a wearable robot with a footplate that assists patients to perform voluntary muscle movements. RAGT group received RAGT 5 sessions per week at duration 30 minutes with 30 minutes conventional physical therapy in 12 weeks.
15820434|NCT04281381|Diagnostic Test|Cross-sectional imaging|MRI with gadolinium contrast will be the imaging modality of choice. In patients with contraindications to MRI who instead undergo baseline evaluation by CT scan, tumor evaluation will be by serial CT scans with IV contrast throughout the study period.
15820435|NCT04281368|Other|Analysis of IUFD|Each team member in the audit group had access to all the medical patient charts from the hospitals and also the majority of the charts from the antenatal care clinics (ANC). Each team member independently assessed each case regarding causes of death, preventable/non-preventable deaths, the level of delay if there was any and the standard of healthcare provided to the patients with stillbirth, the postmortem examination of infant and mother and if there were any recommendations given for the next pregnancy
15820436|NCT04281355|Procedure|Omission of axillary lymph node dissection|Axillary lymph node dissection will be replaced by axillary radiotherapy in Randomisation B
15820437|NCT04281355|Radiation|Omission of regional irradiation|Regional irradiation will be omitted in the interventional arm of Randomisation A.
15820438|NCT04281342|Drug|Aprocitentan 25 mg|Repeated administration of a 25 mg oral dose of aprocitentan, once daily from Day 1 to Day 10, followed by 18 days of observation.
15820439|NCT04281342|Drug|Aprocitentan 100 mg|Repeated administration of a 100 mg oral dose of aprocitentan, once daily from Day 1 to Day 10, followed by 18 days of observation.
15820440|NCT04281342|Drug|Matching placebo|Repeated administration of an oral dose of aprocitentan-matching placebo, once daily from Day 1 to Day 10, followed by 18 days of observation.
15820441|NCT04281342|Other|Moxifloxacin control to establish assay sensitivity|Repeated administration of an oral dose of aprocitentan-matching placebo, once daily from Day 1 to Day 9. On Day 10, oral administration of one single 400 mg moxifloxacin tablet open-label, followed by 18 days of observation.
15820442|NCT04281329|Procedure|Magnetic resonance imaging|Cardiac magnetic resonnance imaging before catheter ablation.
15820443|NCT04281316|Device|Nasal High Flow installation|"Participants randomized in NHF group will receive the nasal high flow (NHF) treatment delivered by myAirvo2.
~Nasal High-Flow (NHF) is a treatment delivering heated, humidified, and optionally oxygen-enriched, air at high flow rates through a nasal cannula. The physiologic effects of NHF are an improvement in gas exchanges including a reduction in hypercarbia an optimization in breathing patterns with a reduction of work of breathing and high compliance as delivered via a comfortable nasal interface"
15820444|NCT04281316|Device|Non Invasive Ventilation|Participants randomized in the Non Invasive Ventilation group will receive treatment as in their usual care.
15820445|NCT04281316|Other|Training session|The patients in the Nasal High Flow (MyAirvo) arm will receive two hours training adaptation session in the hospital
15820446|NCT04281316|Other|Education session|Participants randomized in the Non Invasive Ventilation group will receive an additional educational session of one hour for improving compliance.
15820447|NCT04281303|Procedure|Endoscopic vertical gastroplasty|endoscopic vertical gastroplasty + lifestyle modification
15820448|NCT04281290|Procedure|Electrochemotherapy - electroporation with Cliniporator Vitae® and chemotherapy drug Bleomycin PHC 15 e. (United States Pharmacopeia - USP)|"Procedure: Electrochemotherapy Exploration, anesthesia, pancreatic cancer resection, bleomycin administration, electroporation, formation of all anastomoses.
~Device: Cliniporator Vitae® Positioning of plate electrodes according to landmarks, 8-28 min after administration of bleomycin application of electric pulses (8 pulses, duration 100 microseconds, frequency 8 Hz with amplitude adequate to cover the whole treated lesion with electric field necessary for reversible plasma membrane permeabilization, approximately 1000V/cm), removal of electrodes.
~The maximum duration of procedure is 90 minutes, after liver mobilization.
~Drug: Bleomycin PHC 15 e. (United States Pharmacopeia - USP) Intravenous bolus administration of bleomycin (15 mg/m2)"
15820449|NCT04281277|Device|increase of mean arterial pressure at 80-85 mmHg.|increase of mean arterial pressure at 80-85 mmHg (with catecholamines or volemic expansion).
15820450|NCT04281277|Device|increase of mean arterial pressure at 65-70 mmHg.|increase of mean arterial pressure at 65-70 mmHg (with catecholamines or volemic expansion).
15820451|NCT04281264|Behavioral|Passive Hypoxia|During 30 minutes of session, the participants will perform an intellectual activity while they will be exposed to normobaric hypoxic conditions in a hypoxic chamber (CAT 310, Lousiville, Colorado). They will inspire oxygen fraction (FiO2) set to 16.1% (0.16)
15820452|NCT04281264|Behavioral|Normoxia Circuit Training with Elastic Bands|"Each training sessions will consist of a circuit training with elastic bands, where different muscle groups will be involved (pectoral, shoulders, back, arms, thighs, legs and abdominals). Duration of the session will be about 30 minutes, which will include 10 minutes warm-up consisting of slight movements, and 5 minutes of static stretching for the muscles at the end of the sessions. Main section of the sessions will be a circuit that will be composed by 3 sets of 12-15 repetitions of nine different exercises.
~Subjects will inspire FiO2 of 21.0% (0.21)"
15820453|NCT04281264|Behavioral|Hypoxia Circuit Training with Elastic Bands|"Each training sessions will consist of a circuit training with elastic bands, where different muscle groups will be involved (pectoral, shoulders, back, arms, thighs, legs and abdominals). Duration of the session will be about 30 minutes, which will include 10 minutes warm-up consisting of slight movements, and 5 minutes of static stretching for the muscles at the end of the sessions. Main section of the sessions will be a circuit that will be composed by 3 sets of 12-15 repetitions of nine different exercises.
~Subjects will inspire FiO2 of 21.0% (0.21)"
15820454|NCT04281264|Behavioral|Normoxia Vibration|"The subjects will perform dynamic and static vibration exercise provide by a commercially available device (Galileo 2000, Novotec GmbH, Pforzheim, Alemania). The duration of the WBV session will be about 30 minutes, which will include 10 minutes warm-up consisting of slight movements, and 5 minutes of static stretching for the muscles.
~Repetitions of 30 seconds with a frequency of 18.5 Hz will be performed. The rest interval will be 60 seconds between 4 repetitions during weeks 1-12 and 45 seconds between 5 repetitions during weeks 12-24. The vertical amplitude of WBV was set at 2.5 mm. Four stance will be performed on platform.
~Subjects will inspire FiO2 of 21.0% (0.21)"
15820503|NCT04280770|Procedure|23 PARS PLANA VITRECTOMY|We performed a three-port vitrectomy: one infusion trocar and two instruments trocars. Non-contact wide-angle viewing systems (Resight- Biom) have a viewing field of 60-130° was used. Put 23 needle attached to the automated pump for silicone oil extraction. Strict examination of the retina to detect new breaks or untreated breaks. Closure of the sclerotomies.
15820504|NCT04280757|Procedure|Biopsied ICSI embryos (PGS)|Biopsied ICSI embryos (PGS)
15820455|NCT04281264|Behavioral|Hypoxia Vibration|"The subjects will perform dynamic and static vibration exercise provide by a commercially available device (Galileo 2000, Novotec GmbH, Pforzheim, Alemania). The duration of the WBV session will be about 30 minutes, which will include 10 minutes warm-up consisting of slight movements, and 5 minutes of static stretching for the muscles.
~Repetitions of 30 seconds with a frequency of 18.5 Hz will be performed. The rest interval will be 60 seconds between 4 repetitions during weeks 1-12 and 45 seconds between 5 repetitions during weeks 12-24. The vertical amplitude of WBV was set at 2.5 mm. Four stance will be performance on the platform.
~Participants will inspire a fraction of inspired oxygen (FiO2) of 16.1% (0.16)"
15820456|NCT04281251|Procedure|Endoscopic retrograde appendicitis therapy|"Colonoscopy would be introduced until visualization of the appendiceal orifice. Catheter would be placed in the appendix and decompression performed. After removal of appendicolith, plastic stent would be placed for drainage of appendix.
~For patients successfully treated with initial endoscopic drainage, they would be re-admitted at 1 weeks after index procedure for repeat colonoscopy. After reaching the appendiceal orifice, the previous plastic stent would be removed. A contrast appendicogram would be repeated by introducing a wire-guided catheter in the appendix, and any residual fecalith would be removed. Finally, a repeat contrast appendicogram would be performed to confirm complete clearance of fecalith."
15820457|NCT04281238|Other|Yoga group|Yoga training 3 days a week for 8 weeks. In addition to this, home exercises 5 days a week for 8 weeks
15820458|NCT04281238|Other|Control group|Home exercises 5 days a week for 8 weeks
15820459|NCT04281225|Behavioral|Attention to Variability (ATV)|In Attention to Variability we ask the participant to attend to the natural fluctuations in mood and behavior that occur throughout the day, and to notice changes they experience with their hearing loss symptoms; noticing if it is better or worse and to ask why it may be.
15820460|NCT04281225|Other|Placebo|Participants are told that the device they will be testing will improve their hearing, when in fact the device is not a hearing aid but just a metallic earring.
15820461|NCT04281199|Procedure|Hematopoietic Cell Transplantation|Undergo HCT
15820462|NCT04281199|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
15820463|NCT04281199|Radiation|Tomotherapy|Undergo IMRT with tomotherapy
15820464|NCT04281199|Radiation|Total-Body Irradiation|Undergo TBI
15820465|NCT04281199|Radiation|Volume Modulated Arc Therapy|Undergo IMRT with VMAT
15820466|NCT04281160|Device|BeCare Mobile App|The BeCare App is a mobile application that will perform routine assessments of neurological function in individuals with MS and address the most relevant domains that are affected in MS: cognition, afferent visual functioning, motor functioning, fine motor functioning, coordination, gait, and endurance
15820467|NCT04281147|Drug|Radium-223 dichloride (Xofigo, BAY88-8223)|Follow clinical administration
15820468|NCT04281134|Device|Summit RC+S System|"Summit RC+S System consists of:
~(i) One Model B35300R Olympus RC+S neurostimulator; (ii) One Model 4NR009 Patient Therapy Manager; (iii) One Model 4NR011 Clinician Telemetry Module; (iv) Two Model 3387 DBS leads; (v) Two Model 37087-60 DBS extensions; and (vi) One Model 97755 Recharger."
15820469|NCT04281134|Other|One Month Blinded Discontinuation Period:|"The subject and Independent Evaluators are blinded to timing of discontinuation. In all cases, the sequence will be as follows in one-week segments: 100% Active, 50% Active, Sham and Sham. Subjects will be seen weekly. Amplitude will be reduced by 50% at start of week 2 and turned off at start of week 3. Subjects will be told that DBS will be discontinued at some point during the 4 weeks. The purpose of the 50% initial reduction is to minimize rebound effects. The programmer (not the PI in this case) will be open to the design and perform sham activation as described previously. Relapse is defined as a 25% increase of the Y-BOCS over two consecutive visits compared to discontinuation baseline."
15820470|NCT04281121|Dietary Supplement|omega 3 fatty acids|: Life style modification, diet regimen and Omega-3 fatty acids supplementation: The dose of omega-3 fatty acids depended on the weight of patients according to World Health Organization recommendations 400 milligrams per 10 kilograms of body weight and had been given into two doses per day, before morning and evening meals
15820473|NCT04281095|Drug|Botulinum toxin type A|Total of 20U/0.5mL is intramuscularly administered to five points of the glabellar region, 4U/0.1mL each
15820474|NCT04281082|Drug|ursofalk|To study the genetic polymorphisms in pregnant women with ICP treated with ursoflak and in their first degree relatives
15820475|NCT04281056|Procedure|Tooth removal and their replacement by means of a denture|Teeth have been removed and replaced by means of dentures for at least one year
15820476|NCT04281030|Behavioral|PMR (Progressive muscle relaxation therapy)|Technique for learning to monitor and control the state of muscular tension. The relaxation therapy should take about 20 minutes a day.
15820477|NCT04281030|Behavioral|Monitored Usual Care (MUC)|General Education Session consisting of basic migraine information of basic migraine information such as evidence-based ways to treat migraines: treat early, limit acute medications < 2-3 days/week, and call the primary care physician (PCP) if abortive medications are used more frequently.
15820478|NCT04281017|Drug|TIVA|Induction with 1% propofol (2-3 mg/kg), fentanyl (1-3 mg/kg), and Rocuronium 1-1.5 mg/kg. Before the injection of propofol, 5 mL 1% lidocaine (50 mg)
15820479|NCT04281017|Drug|Balanced anesthesia|Induction with 1% propofol (2-3 mg/kg), fentanyl (1-3 mg/kg), and Rocuronium 1-1.5 mg/kg. Before the injection of propofol, 5 mL 1% lidocaine (50 mg
15820480|NCT04281004|Biological|Amniotic Fluid (AFED)|One drop (0.25 mL) of Amniotic Fluid Eye Drops (AFED) in each eye four times daily for seven days
15820481|NCT04281004|Other|Saline Solution|One drop (0.25 mL) of Saline Solution in each eye four times daily for seven days
15820482|NCT04280991|Other|Moderate intensity exercise under mild normobaric hypoxia and normoxia|The participant will perform the exercise interventions consisting of cycling at the heart rate corresponding with 50%WMAX (normoxia) or heart rate corresponding with 50% WMAX (hypoxia) for 30 minutes, twice a day, for 4 consecutive days. 24h glucose concentration will be monitored continuously.
15820505|NCT04280744|Other|Music therapy|Patient preferred song will be provided in a sedative manor (e.g., 60-80 beats per minute) using live music (singing with guitar accompaniment) by a board certified music therapist.
15820506|NCT04280731|Dietary Supplement|fermented quinoa|Quinoa drink fermented with lactic acid bacteria isolated from food
15820483|NCT04280978|Diagnostic Test|ABI ABC|"The assessor will administer ABaCo test through a computer device and she will marked the responses on a paper sheet. Video recordings are needed only to allow an impartial scoring. In fact, an external trained judge will do the scoring.
~Furthermore the linguistic abilities will be assessed through the administration of some subtests of the Italian battery BVL 4-12. In particular, the researcher will administer the following subtests: naming, lexical comprehension and grammatical comprehension.
~Moreover, some neuropsychological abilities will be analysed using the test BVN 5-11. In addition, the theory of mind and the non-verbal IQ will be assessed.
~The Socio-Economic-Status of the family involved in the research will also be investigated, considering its importance on the rehabilitation outcomes."
15820484|NCT04280965|Drug|Quetiapine Fumarate|Atypical antipsychotic
15820485|NCT04280965|Other|Standard of care meducations|SSRI's/SNRI's/Trazodone/Prazosin/Hydroxyzine
15820486|NCT04280952|Device|CONVIVO|tumor tissue with the CONVIVO system
15820487|NCT04280939|Procedure|spinal anesthesia|prospective randomized double-blind study of patients undergoing total hip or knee replacement, as well as partial knee replacements (medial, lateral, patellafemoral, or bilateral). All groups will be matched for age, sex, American Society of Anesthesiologists class, and type of surgery. An attempt will be made to achieve a similar proportion of THA, TKA, and partial knee replacements in each group. We will randomize patients to one group of spinal anesthesia protocole.
15820488|NCT04280926|Diagnostic Test|Cardiac Troponin Testing|Fresh serum or lithium heparin plasma samples will be measured with the Atellica IM TnIH assay (Siemens Heatlhineers).
15820489|NCT04280913|Other|retrospective analysis|The investigators retrospectively analyzed the hospitalized patients with COVID-19.
15820490|NCT04280900|Behavioral|Virtual Reality-Enhanced Cognitive Behavioral Therapy (VR-CBT)|use of cybertherapy (8 sessions) in addition to cognitive behavioral therapy (4 sessions) (pharmacological treatment are note modified)
15820491|NCT04280900|Behavioral|Treatment as usual|Treatment as usual is a cognitive behavioral therapy I (4 sessions) (pharmacological treatment are note modified)
15820492|NCT04280887|Device|MyPad|Ultrasound bed wetting alarm
15820493|NCT04280874|Drug|Dinoprostone 0.5 MG|0.5mg dinoprostone applied intracervically
15820494|NCT04280874|Drug|Dinoprostone 2 MG/2.5 ML Vaginal Gel/Jelly|2mg dinoprostone applied intravaginally
15820495|NCT04280861|Other|Multicomponent Intervention|Multicomponent intervention conducted by and expert psychologist that target different aspects of the caregiving experience (affective responses, communication skills, burden experience, social support and loneliness, cognitive performance, the practice of mindfulness and health-related behaviours). The number of sessions will be 8, 1 session of 90 minutes a week, and the number of participants will be 12-14 per group. In some sessions other collaborators will be invited to participate (social workers, physiotherapist).
15820496|NCT04280848|Drug|UCPVax|"The UCPVax vaccination protocol will start at least one month after glioblastoma patients have completed the concomitant radiochemotherapy (Radiotherapy + Temozolomide RT/TMZ), without the 6 additional monthly cures of temozolomide, with a maximum of 45 days.
~UCPVax vaccine will be emulsified in Montanide ISA 51 and injected subcutaneously at days 1, 8, 15, 29, 36 and 43 (priming phase) following by boost vaccination one month after the last injection and then every 8 weeks for 12 months maximum."
15820497|NCT04280835|Behavioral|Group Psychoeducation that Focused on Social Skill Development|Psychoeducation Program consists of; Preparatory Session, Recognition of Schizophrenia, Evaluating the Treatment of Schizophrenia, Stress and Coping with Stress, Improving Communication Skills, Improving Problem-solving Skills, Improving Interpersonal relationships and social activities and Evaluating Session.The sessions were held in the form of PowerPoint presentations. In the psychoeducation program, lecture, question-answer, homework, sharing experiences, group discussion, repetition, video presentation, summarization, reinforcer, and role-playing techniques were used. The day before each session, patients were phoned and reminded of the time of the session. At the end of each session, the content of the subject is given as hard copy and cookies, tea and coffee were served.
15820498|NCT04280822|Drug|Neoadjuvant immunochemotherapy|"Neo-adjuvant chemotherapy(cisplatin and paclitaxel):
~Paclitaxel, 175mg/m2, d1, Cisplatin, 75mg/m2, d1, 3 week, 2 cycles. JS001, 240mg ivgtt, d3, >30min, 3week, 2 cycles
~Surgery:
~2-3weeks after Neo-adjuvant chemotherapy Surgeons: the operation shall be performed by senior thoracic surgeons. Try to achieve the consistency of operation quality.
~Operation: the thoracic esophagectomy must be through right thoracic cavity. (open and minimally invasive McKeown or Ivor Lewis). Total two-field lymphadenectomy (right and left recurrent laryngeal nerve lymph nodes must be included).
~After surgery/ maintain period:
~JS001, 240mg ivgtt, d3, >30min, 3week (8 cycles at most)"
15820499|NCT04280809|Device|GaAlAs laser|GaAlAs laser (AMD Picasso, Dentsply Sirona, York, Pennsylvania, USA) with a wavelength of 810 nm was placed intraorally, at a distance of 1 cm in the position of the extracted tooth socket and circling in a 2 cm - diameter area. The power applied was 0.5 ± 20% W, continuously for 30 s. The total real energy released was 12.8 J and the real energy density applied was 4 J/cm2. Each patient was irradiated 3 times consecutively right after surgery, day 1 and day 2 after surgery
15820500|NCT04280796|Behavioral|psychophysical tasks|"All participants perform two psychophysical tasks to assess sensory-discriminative and emotional-motivational pain responses independently from each other.
~In addition, in Substudy 1 an operant learning paradigm will be implement to dissociate these responses, increasing the sensory-discriminative pain responses compared to emotional-motivational pain responses by contingent monetary reinforcement or vice versa.
~In Substudy 2, responses of chronic pain patients will be compared to those of healthy participants to characterize possible alterations and operant learning will be operationalized to decrease emotional-motivational pain responses, which are assumed to be already increased in the patients."
15820501|NCT04280783|Behavioral|The Physical Activity for The Heart (PATH) intervention|The web-based Physical Activity for The Heart (PATH) intervention leverages openly accessible platforms, such as YouTube, to proffer workout videos that match the participants preferences. Currently, PATH includes over 90 workout videos vetted by a team of experts and curated on the PATH website in 3 controlled levels of intensity (beginner, intermediate, proficient) to foster gradual progression from low to high intensity PA in accordance with the FITT-VP (frequency, intensity, time, type, volume, progression) principle.
15820502|NCT04280783|Behavioral|Be Active Your Way Booklet|Be Active Your Way booklet was developed by the Centers for Disease Control (CDC) to help individuals integrate PA in their daily lives. It simply encourages individuals to increase their PA gradually and gives them examples of things that they can do.
15820508|NCT04280705|Other|Placebo|The supplied placebo lyophilized formulation is identical in physical appearance to the active lyophilized formulation and contains the same inactive ingredients. Alternatively, a placebo of normal saline of equal volume may be given if there are limitations on matching placebo supplies.
15820509|NCT04280705|Drug|Remdesivir|Drug Remdesivir is a single diastereomer monophosphoramidate prodrug designed for the intracellular delivery of a modified adenine nucleoside analog GS-441524. In addition to the active ingredient, the lyophilized formulation of Remdesivir contains the following inactive ingredients: water for injection, sulfobutylether beta-cyclodextrin sodium (SBECD), and hydrochloric acid and/or sodium hydroxide.
15820515|NCT04280679|Device|Sonovein 2|Patient are treated with the HIFU device and the pysician is doing a compressive bandage
15820516|NCT04280653|Device|NDE L68 StableFit® Punctal Plug|Tear lake evaluation of the planned study eye, prior to insertion of the Punctal Plug and then tear lake evaluation at days 7 and 28 after punctal plug insertion.
15820518|NCT04280627|Other|Sample Collection|This study will involve the collection of oral swabs, saliva, urine and faeces samples, blood and skin scrapings from patients before and after kidney and pancreas transplantation at day 0, day 1, week 1 and at 3, 6 and 12 months post-transplant.
15820519|NCT04280614|Behavioral|Dialectical behaviour therapy (DBT)|DBT is based on the behavioural therapy principals focusing on four main modules: mindfulness, interpersonal effectiveness, emotional regulation and distress tolerance. The therapy is taught in a group and individual therapy model with coaching during periods of crisis. CBT is a standard model of therapy similar to DBT but is more direct in focusing clients on changing maladaptive behaviours or thoughts to effectively manage difficult emtions.
15820520|NCT04280601|Dietary Supplement|vitamin D|Patients with insufficient and/or deficient vitamin D status (<75 nmol/L) at study enrolment will be instructed to take a 12-month supply of vitamin D3 supplementation (to a maximum of 2,000 IU/day) vs. those with sufficient status will be observed for 12-months
15820521|NCT04280588|Drug|Fingolimod 0.5 mg|Each patient in the fingolimod treatment group was given 0.5 mg of fingolimod orally once daily, for three consecutive days
15820522|NCT04280575|Procedure|Percutaneous coronary intervention|Coronary artery stenting for stable angina
15820523|NCT04280562|Device|Sana Pain Reliever|Participants will receive the SPR device and a tablet with instructions of how to use the device and how to answer the questionnaires on the tablet mobile application. Each session with the device will last 16 minutes and run under the device's normal settings. The session consists of periods of light and sounds (beeps). Participants will be instructed to use the device each day at the end of the day prior to going to sleep and whenever they experience heightened pain during the day.
15820524|NCT04280562|Device|Sham SPR|Participants will receive the SPR device and a tablet with instructions of how to use the device and how to answer the questionnaires on the tablet mobile application. Each session with the device will last 16 minutes and run under the device's sham settings. The session consists of periods of light and sounds (beeps). Participants will be instructed to use the device each day at the end of the day prior to going to sleep and whenever they experience heightened pain during the day.
15820525|NCT04280536|Drug|Cohort A|Oral FTD/TPI at RP2D will be administered until disease progression, intolerable toxicity or patient withdrawal.
15820526|NCT04280536|Drug|Cohort B|Oral FTD/TPI at RP2D will be administered until disease progression, intolerable toxicity or patient withdrawal.
15820527|NCT04280523|Drug|ESR-specific PET scan|Lung ESR Density by PET: Investigators will use 18F-FES as an estrogen receptor (ESR)-specific PET tracer to determine lung ESR density. 18F-FES will be prepared according to published methods. Briefly, all subjects will be evaluated by PET imaging, using standardized protocols. Blood will be obtained just before FES injection to measure the endogenous estrogen level [estradiol (E2)], to rule out pregnancy in female patients, and some reserved for future studies of mechanism. Approximately 6 mCi (222 MBq) of 18F-FES will be administered intravenously over 1~2 minutes, with scanning initiated 1 hour after administration of the tracer. Emission scans will be performed of the chest. A multimodality computer platform (Syngo; Siemens) will be used for image review and manipulation.
15820528|NCT04280510|Genetic|Blood sample collection; gastrointestinal biopsy|Targeted Next generation sequencing and whole exome sequencing Phenotyping of intestinal lymphocytes, single cell analyses, cytokines dosage...
15820529|NCT04280497|Drug|Administration procedures|"Hydrocortisone hemisuccinate / hydrocortisone placebo will be given as 50 mg intravenous bolus every 6 hours;
~9 alpha fludrocortisone / 9 alpha fludrocortisone placebo will be given as a 50 μg tablet via a nasogastric tube once per day in the morning.
~Study drugs will be started immediately after randomization (day 0 of the study), until discharge from ICU for a maximal duration of 7 days. Study drugs will be stopped without tapering off."
15820530|NCT04280484|Other|Intermittent Hypoxia|1 minute of 9% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 iterations/episodes.
15820531|NCT04280484|Other|Sham Hypoxia|1 minute of 21% oxygen in the inspired air, alternating with 1 minute of 21% oxygen; for a total of 15 iterations/episodes.
15820532|NCT04280471|Drug|Fecal Microbiota Transplantation Capsule|Receive OpenBiome FMT Capsule DE PO
15820533|NCT04280458|Behavioral|Intentive rehabilitation|"Intervention included:
~psychomotor 5 hours/week ±30 minutes
~kinesitherapy 1.5 hour/week ±20 minutes
~during 12 months."
15820534|NCT04280458|Behavioral|Routine care|"Intervention included:
~kinesitherapy 0.5 hour/week ±10 minutes
~psychomotor 30 min/week ±10 minutes during 12 months."
15820535|NCT04280445|Other|Psychological therapy|Acceptance and Commitment Therapy (ACT) is a trans-diagnostic approach which aims to promote better living by supporting clients through six key processes (e.g. mindfulness, values). ACT does not aim to reduce distress, rather its goal is to promote better living or a better quality of life despite distress (Hayes, Strosahl & Wilson, 1999). ACT has been shown to have equal or superior efficacy to CBT with a number of psychological and physical health conditions (A-Tjak et al., 2015; Ruiz, 2012).
15820536|NCT04280432|Procedure|CESAREAN|Women hospitalized for cesarean section
15820537|NCT04280406|Drug|Azithromycin|azithromycin 500mg one hour before implant placement
15820538|NCT04280406|Drug|Placebo oral tablet|identical placebo one hour before implant placement
15820539|NCT04280393|Device|Colonoscopy procedure with endocuff|Colonoscopy procedure with the use of ENDOCUFF VISION
15820540|NCT04280380|Diagnostic Test|Real time PCR|At inclusion, serum samples will be collected to determine CMV serological status. Plasma samples will be collected weekly for CMV PCR analysis. Antibodies for CMV will be assessed using a commercial enzyme immunoassay kit for detection of total antibodies to CMV (LIAISON CMV IgG assay, DiaSorin S.p.A). DNA will be extracted in 200 μL of plasma eluted in 60 μL of elution buffer using a NucliSENS easyMAG system (bioMérieux, Boxtel, The Netherlands). Samples will be amplified using Affigene CMV Trender diagnostic assay (Cepheid AB, Bromma, Sweden), according to the manufacturer instructions. Amplification will be performed on a MX3000P instrument (Stratagene Instruments Systems, La Jolla, CA, USA). Samples with >500 copies/mL of plasma will be considered positive.
15820541|NCT04280367|Diagnostic Test|Standardised semi-structured talk|Comprehensive assessment of at-risk mental states (CAARMS) will be used.
15820542|NCT04280367|Diagnostic Test|Autistic spectre disorder screening|Autism-spectrum quotient (AQ) auto-questionnaire will be used.
15820543|NCT04280367|Diagnostic Test|Anxiety measuring|An inventory for measuring clinical anxiety: Beck Anxiety Inventory (BAI); Liebowitz Social Anxiety Scale.
15820544|NCT04280354|Other|compare data patterns by data-driven algorithms to determine sepsis|compare data patterns by data-driven algorithms including machine learning and multi-dimensional modelling to reliably determine sepsis
15820545|NCT04280354|Other|compare data patterns by data-driven algorithms to predict sepsis-related mortality|compare data patterns by data-driven algorithms including machine learning and multi-dimensional modelling to to predict sepsis-related mortality
15820546|NCT04280341|Biological|RC48-ADC in combinaton with JS001|"The study has 2 parts which include dose escalation phase and dose extension phase.
~Dose escalation will use a 3+3 design and will enroll cohorts of 3-6 patients with HER2-Positive Advanced Malignant Solid Tumors sequentially at escalating doses of 2.0mg/kg and 2.5mg/kg to RC48-ADC and JS001 is fixed dose of 3.0mg/mg"
15820547|NCT04280328|Drug|Ciforadenant|100 mg orally twice daily for 28-day cycles
15820548|NCT04280328|Drug|daratumumab|"16 mg/kg administered intravenously as follows based on 28-day cycles:
~Cycles 1 - 2: Days 1, 8, 15, and 22
~Cycles 3 - 6: Days 1 and 15
~Cycles 7 - 24: Day 1"
15820549|NCT04280302|Behavioral|Virtual Reality-based Rehabilitation|VR-based eye stabilization exercises and balance exercises
15820550|NCT04280302|Behavioral|Conventional Therapy|Conventional rehabilitation therapy based on eye stabilization exercises and balance exercises
15820551|NCT04280289|Drug|cannabidiol extract|"The test article CBD Cannabis Extract Oral Solution will be manufactured by the University of Mississippi National Center for Natural Products Research (NCNPR) at the Coy Waller Laboratory under FDA Current Good Manufacturing Practices. The drug product, derived from hemp and containing less than 0.3% of Δ9-tetrahydrocannabinol, is no longer a Drug Enforcement Agency (DEA) controlled substance. DEA registrations are not required for the manufacturing, handling or dispensing of these clinical test materials"
15820552|NCT04280276|Diagnostic Test|TruGraf test|To obtain longitudinal TruGraf testing in patients with stable creatinine, high and normal IPV in tacrolimus levels, between 3 and 18 months post-transplant at the University of Maryland post-transplant clinic.
15820553|NCT04280263|Drug|Caffeine|caffeine tables containing 150mg caffeine will be provided to patients with instructions to take twice per day
15820554|NCT04280263|Drug|Placebo oral tablet|oral placebo tablets matching the caffeine tablets and will be provided to patients with instructions to take twice per day
15820555|NCT04280250|Other|Volitional Help-Sheet|Self-help sheet in order to form implementation intentions
15820556|NCT04280250|Other|Control condition|Psychoeducational self-help sheet
15820557|NCT04280237|Other|Blood samples|Blood samples
15820558|NCT04280224|Biological|NK Cells|twice a week of NK cells (0.1-2*10E7 cells/kg body weight)
15820559|NCT04280211|Other|Respiratory Assessment|Spirometric measurement
15820560|NCT04280211|Other|Vestibular Assessment|Assessment of peripheral vestibular dysfunction, angular vestibule ocular reflex, vestibular dysfunction
15820561|NCT04280211|Other|Balance Assessment|Postural stability
15820562|NCT04280198|Behavioral|Triple P Parenting Videos|Four video clips from the online Triple P Parenting program will be used to promote specific positive parenting practices.
15820563|NCT04280198|Behavioral|Activity Boxes|There will be about 4 planned activities per week within activity boxes provided to families. The activities will be a context in which the positive parenting behaviors can be practiced. Each activity will take about 15 minutes. Families can pick each week whether they'd like their parenting practice to be embedded in reading activities, nature walks/active games, or arts and crafts. Instructions will be included with each activity, including prompts to allow the parent to apply learnings from that week's parenting video and to allow interactions to be child-led.
15820564|NCT04280185|Procedure|Hyperthermic Intraperitoneal Chemotherapy|HIPEC is a way of intraperitoneal chemotherapy
15820565|NCT04280172|Other|Cultural Competence Education|Cultural competence education for participants in the intervention group comprises of completion of an online learning module and participation in an eight-hour training day. The educational content includes various topics related to cultural and linguistic diversity and cultural competence in mentoring.
15820566|NCT04280172|Other|Standard Mentoring Education|Participants in the control group will not receive the educational intervention but will participate in standard mentoring education. This education is offered in an online learning environment and participants can complete the education at their own pace. The educational content focuses on general issues related to mentoring and does not contain topics specific to cultural competence in mentoring.
15820567|NCT04280146|Behavioral|daily energy intake|Investigate daily energy intake according to eating rate and food processing
15820568|NCT04280133|Behavioral|Educational Video Tool|The video educational tool was written by the investigators in collaboration with a panel of experts on CAR T-cell therapy, medical ethicists, palliative care clinicians, and oncologists.
15820596|NCT04279847|Drug|INCB057643|INCB057643 dose escalation (Part 1) and dose expansion (Part 2).
15820569|NCT04280120|Other|Neural Mobilisation|Neural mobilization was applied by gently holding the lower part of the ear between the index finger and thumb. The thumb was placed at the opening of the external auditory meatus and the index finger placed behind the auricle of the ear (Figure 2). The intensity of auricular traction was determined by the patient reporting the level of discomfort. The patient tolerated 3-4 sets of gentle horizontal traction and circular movement 25 times each with 5 seconds rest.
15820570|NCT04280120|Other|Massage therapy|Massage therapy consisting of tapping, effleurage and finger and thumb kneading for 15-16 minutes.
15820571|NCT04280120|Diagnostic Test|Faradic electrical stimulation|Faradic electrical stimulation with anode electrode at the back of the neck and cathode over the nerve trunk anterior to the earlobe. The cathodic pen electrode was used to locate the facial nerve trunk for stimulation manually. (Biphasic current, pulse time 300 microseconds, frequency 60 Hz, 20 contractions, Rest 10 seconds). The total treatment time was 15 minutes.
15820572|NCT04280120|Other|Exercises|Exercises in front of the mirror like raising the eyebrow, clinching the teeth (patient trying to see his clenched teeth in the mirror), smiling and performing other facial expressions for 12-15 minutes.
15820573|NCT04280081|Drug|Selpercatinib|Administered orally
15820574|NCT04280068|Behavioral|Clinician Guide (CG)|An evidence-based, intervention approach to reduce heavy drinking in primary care settings.
15820575|NCT04280068|Behavioral|Clinician Guide plus HealthCall|HealthCall is a smartphone application designed to help participants keep track of their daily alcohol use, medication adherence and a few other health behaviors through brief daily use.
15820576|NCT04280055|Drug|Psilocybin|0.14 mg/kg p.o. in three sessions spaced by one week
15820577|NCT04280029|Device|SELUTION SLR™ DEB|The SELUTION Sustained Limus Release (SLR)™ drug-eluting balloon (DEB) catheter is a combination product consisting of a standard percutaneous transluminal angioplasty (PTA) balloon catheter coated with a drug (Sirolimus). The drug coating is formulated with Sirolimus microspheres suspended in a phospholipid blend. The balloon catheter component of the SELUTION SLR™ DEB is a conventional single use, sterile, rapid exchange catheter to dilate vascular lesions. The semi-compliant balloon is inflated for 60 seconds (minimum of 30 seconds) to transfer the Sirolimus loaded microspheres to the target vessel wall. The balloon is then deflated and removed from the body.
15820578|NCT04280029|Device|Control|The treating physician may chose to implant a commercially available DES or alternatively may use POBA only to treat the patient. Choice of DES is at the treating physician's discretion, but is limited to ZES and EES devices
15820580|NCT04280003|Other|Alogenic adipose tissue-derived stem cells|Concentration of the cells: 10 million cells / ml
15820581|NCT04280003|Drug|Placebo solution|Placebo intravenous solution, same appearance stem cells solution
15820582|NCT04279990|Other|No intervention: assessment of GI function|"Gastrointestinal function is assessed by the intragastric pressure measurement by a high resolution manometry. This is an examination test considered standard of care for the diagnosis of functional dyspepsia in the university hospital of leuven.
~The joint hypermobility syndrome is assess by means of the Brighton criteria."
15820583|NCT04279964|Behavioral|Boot Camp Translation|Practices in the intervention arm will participate in the Boot Camp Translation process, where BCT Community Advisory group members will come together to develop and implement practice relevant materials to promote adolescent vaccination.
15820584|NCT04279964|Other|Control|No intervention. Practices will continue to behave as usual.
15820585|NCT04279951|Other|Resistance exercise|High-load and low-load resistance exercise two times per week for 10 weeks, preceded by 3 weeks of familiarization to training (high-load training)
15820586|NCT04279951|Dietary Supplement|Omega-3|1 gram of omega-3 per day for 20 weeks
15820587|NCT04279951|Dietary Supplement|Placebo|1 gram of sunflower oleic oil per day for 20 weeks
15820588|NCT04279938|Drug|Tinostamustinein|Tinostamustine80-120mg IV Q3W (dose to be determined in part 1) for 6 cycles
15820589|NCT04279938|Drug|Pembrolizumab|Pembrolizumab 200mg IV Q3W until disease progression or unacceptable toxicities (max. 2 years)
15820590|NCT04279938|Drug|Rituximab|Rituximab 375 mg/m2 IV Q3W for 6 cycles
15820591|NCT04279925|Device|ORIF (Open reduction internal fixation): locally-made miniplate and screw|"Open reduction implies that broken bone is being realigned using surgery (as opposed to a closed reduction performed without surgery). Internal fixation refers to the hardware used to ensure that the bone is stabilized and held in place so that it is able to heal.
~Sample of the study is the midface fracture line founds on patients who met inclusion and exclusion criteria. Bone density of each subject will be evaluated and recorded in Hounsfield Unit (HU). the Bone density between the sample (fracture line) received either Imported miniplate and screw and locally made miniplate and screw will be compared
~the subject about to received whether the imported or locally-made miniplate and screw will be randomized using predetermined randomization list"
15820592|NCT04279925|Device|ORIF: Imported miniplate and screw|"Open reduction implies that broken bone is being realigned using surgery (as opposed to a closed reduction performed without surgery). Internal fixation refers to the hardware used to ensure that the bone is stabilized and held in place so that it is able to heal.
~Sample of the study is the midface fracture line founds on patients who met inclusion and exclusion criteria. Bone density of each subject will be evaluated and recorded in Hounsfield Unit (HU). the Bone density between the sample (fracture line) received either Imported miniplate and screw and locally made miniplate and screw will be compared
~the subject about to received whether the imported or locally-made miniplate and screw will be randomized using predetermined randomization list"
15820593|NCT04279912|Device|Focused Ultrasound (MRgFUS) for the Management of Tremor in Patients With Multiple Sclerosis|The intervention is MRIgFUS thermal ablation of the ventral intermedius (Vim) thalamus contralateral to the most affected side of the body.
15820594|NCT04279886|Other|Three-dimensional scans|All included healthy volunteers received 6 three-dimensional scans, utilizing 3 different scanning systems (2 scans per system)
15820595|NCT04279873|Diagnostic Test|Microbiological diagnostics on pulmonary secretion|Culture, 16s, 18s, next generation sequencing
15820597|NCT04279847|Drug|Ruxolitinib|Ruxolitinib will be administered twice a day using the dose designated as the stable dose at the time of the screening visit for each subject. Acceptable doses are 5 mg BID to 25 mg BID.
15820598|NCT04279834|Behavioral|PAP Treatment|Motivational enhancement plus remote-monitoring and participant self-monitoring of PAP use.
15820599|NCT04279834|Behavioral|Sleep Education I|Motivational enhancement plus participant self-monitoring of sleep.
15820600|NCT04279834|Behavioral|Sleep Education II|Education about sleep health.
15820601|NCT04279808|Procedure|dilator depth|For soft tissue dilation just after guidewire insertion in central venous catheterization through the right internal jugular vein, investigators will measure the distance between the skin puncture site and outside of anterior wall of the vein with real-time ultrasonography in the measured depth group. Next, practitioner will insert the dilator by the measured length and continue to insert the central venous catheter. For the conventional group as a control group, practitioner will perform the central venous catheterization with a manner used routinely by the practitioner.
15820602|NCT04279782|Other|Comprehensive treatment|Comprehensive treatment includes antiviral therapy, antibiotics therapy, symptomatic treatment, supportive therapy.
15820603|NCT04279769|Drug|CB-280|CB-280, oral capsule administered twice daily at the assigned dose level for 14 days
15820604|NCT04279769|Drug|Placebos|Placebo oral capsule administrated twice daily at the assigned dose level for 14 days
15820605|NCT04279756|Other|Hip Mobilization with Movement, Self-Mobilization with Movement, Dynamic Stretch|Participants receive either a therapist performed mobilization with movement, a self-mobilization with movement, or a dynamic stretch.
15820606|NCT04279743|Dietary Supplement|omega-3 phospholipids|"The intervention is a randomized double blind parallel design testing the metabolism of a krill oil omega-3 phospholipid supplement compared to fish oil omega-3 triglycerides in carriers and non-carriers of the ApoE4 allele. Half of the carriers and non-carriers will receive phospholipids and the other half will receive triglycerides. The intervention choice will be randomized and double blind.
~Participants will be instructed to take 4 supplements every day (2 in the morning and 2 in the evening) (4 g/ day of phospholipids), providing 1.8 g/day of omega-3 fatty acids. They will come back fasted to the research center on weeks 0, 1, 2, 3, 4, 8 and 12 of the study for blood draws. The omega-3 fatty acids metabolism will be compared between the carriers and non carriers of the ApoE4 allele."
15820607|NCT04279743|Dietary Supplement|omega-3 Triglycerides|"The intervention is a randomized double blind parallel design testing the metabolism of a krill oil omega-3 phospholipid supplement compared to fish oil omega-3 triglycerides in carriers and non-carriers of the ApoE4 allele. Half of the carriers and non-carriers will receive phospholipids and the other half will receive triglycerides. The intervention choice will be randomized and double blind.
~Participants will be instructed to take 4 supplements every day (2 in the morning and 2 in the evening), providing 1.8 g/day of omega-3 fatty acids. They will come back fasted to the research center on weeks 0, 1, 2, 3, 4, 8 and 12 of the study for blood draws. The omega-3 fatty acids metabolism will be compared between the carriers and non carriers of the ApoE4 allele."
15820608|NCT04279717|Other|Observation|No interventions planned: treatment of patients at the discretion of the treating/responsible physician
15820609|NCT04279717|Other|Observation|No interventions planned: treatment of patients at the discretion of the treating/responsible physician
15820610|NCT04279678|Procedure|Mitral valve repair|surgical repair of moderate ischemic mitral regurgitation using pericardial patch or rigid semi-annular ring
15820611|NCT04279665|Device|Virtual Reality (VR)|20 minutes of wearing a virtual reality headset with a choice of 4 environments based on their preference and another 20 minutes with a less immersive condition
15820612|NCT04279652|Other|Combined exercise|Combined exercise program consists of 5 min warm-up exercises, 20 min aerobic exercise, 20 min balance-coordination exercises, 10 min strengthening exercises and 5 min cooling exercises.
15820613|NCT04279639|Behavioral|qigong|Patients of the Pain Management Unit either experience usual treatment, or usual treatment plus qigong practice.
15820614|NCT04279626|Procedure|LETS-M|A 1.5-centimeter skin incision was made over the umbilicus, and the abdominal wall was opened layer by layer with an open method. A wound retractor (Alexis, 2-4 centimeter; Applied Medical Resources Corp., Rancho Santa Margarita, CA) was placed, and the glove port was set up, with a 10-millimeter trocar in the thumb over patient's right side, and a 5-millimeter trocar in the little finger over the left side. The pneumoperitoneum was established. A 10-millimeter rigid laparoscope was inserted via the 10-millimeter trocar and controlled by the assistant. The ancillary 5-millimeter port was made over the left lower abdomen under laparoscope inspection. The surgeon performed the surgery via the two 5-millimeter trocars.
15820615|NCT04279613|Drug|NNC0361-0041|Recombinant supercoiled plasmid encoding four human proteins: (pre-proinsulin (PPI), transforming growth factor β1 (TGF-β1), interleukin-10 (IL-10), and interleukin-2 (IL-2) is administered s.c. via syringe and needle.
15820616|NCT04279613|Other|Placebo|Placebo
15820617|NCT04279600|Dietary Supplement|Taurine|Taurine supplementation in capsules of 1 gram of taurine powder, total dosage: 3 grams/day
15820618|NCT04279600|Dietary Supplement|Placebo|Placebo supplementation in capsules of 1 gram of starch powder, total dosage: 3 grams/day
15820619|NCT04279600|Other|Exercise training|4 weeks of combined exercise training (alternating strength and aerobic exercise), with a frequency of 3 times/week with 55 min/day.
15820620|NCT04279587|Behavioral|Residential camp|Intensive education at a residential camp.
15820621|NCT04279574|Device|Lithium disilicate onlays (IPS emaxCAD/Ivoclar)|Restoration of posterior teeth
15820622|NCT04279574|Device|Chairside zirconia crowns (3M)|Restoration of posterior teeth
15820623|NCT04279561|Procedure|Computed Tomography|Undergo 68Ga-PSMA-11 PET/CT
15820624|NCT04279561|Drug|Gallium Ga 68 Gozetotide|Given IV
15820625|NCT04279561|Procedure|Positron Emission Tomography|Undergo 68Ga-PSMA-11 PET/CT
15820626|NCT04279548|Device|Deep Brain Stimulation|Patients will have a stimulation electrode inserted neurosurgically by neuronavigation to the PSI, on the target used for drTMS, on the insula contralateral to the pain side. After surgery will be randomized to be in in either the ON or OFF DBS
15820627|NCT04279535|Drug|Topical Ascorbic Acid|Twice daily application of 300 microliters of 30% ascorbic acid solution with a small cuticle brush.
15820630|NCT04279509|Procedure|Tumor Core Biopsy|"Performed up to a maximum of 3 time points - baseline upon study enrolment, at the completion of treatment, and upon disease progression.
~Four to six tumour core samples will be obtained at each time point. At least two tumour cores will be sent fresh to Invitrocue Pte Ltd for generation of patient-derived organoids for drug-panel screening, at least 1-2 tumour cores at each time point will be stored in formalin and paraffin-embedded for immunohistochemistry analysis of biomarkers, while the remaining 1-2 tumour cores will be stored in liquid nitrogen for subsequent DNA, RNA and protein extraction for biomarker studies including gene expression and proteomics analyses."
15820631|NCT04279509|Procedure|Blood sampling|Germline DNA at baseline for pharmacogenetics analysis. Serial plasma samples for circulating tumour cells and biomarkers, at baseline, prior to day 1 of each cycle while on treatment, at the end of treatment (either upon disease progression or upon completion of predetermined cycles of chemotherapy).
15820632|NCT04279483|Behavioral|7-11|Assigned to make a small (~$2.00) purchase from a 7-11 using a study-provided gift card during each retail environment visit. Specific store to be chosen by study team in consultation with participant according to convenience (near home/work/etc.).
15820633|NCT04279483|Behavioral|CVS|Assigned to make a small (~$2.00) purchase from a CVS using a study-provided gift card during each retail environment visit. Specific store to be chosen by study team in consultation with participant according to convenience (near home/work/etc.).
15820634|NCT04279470|Drug|CAR T-cell and Cellular Therapies|Chimeric Antigen Receptor T-cell and Cellular Therapies for the treatment of a cancer either solid or hematologic malignancy
15820635|NCT04279457|Device|DyeVert Plus System|The DyeVert Plus System also contains a reusable Contrast Monitoring Wireless Display (CMW) which communicates with the Dye-Vert Plus Disposable to allow real-time monitoring and display of contrast volumes manually injected compared to a predefined, physician-entered contrast usage threshold throughout the procedure. At the end of the procedure, the CMW displays total procedure contrast volume used (mL), % of physician specified limit , total procedure contrast volume saved (mL), and % contrast saved
15820636|NCT04279457|Other|Standardized hydration protocol|hydration protocol based up on the Poseidon protocol
15820637|NCT04279444|Dietary Supplement|BKR-017|BioKier, Inc. is developing colon-targeted, oral formulations of natural gut hormone secretagogues as non-prescription medical foods or supplements for nutritional use for improvement of insulin sensitivity.
15820642|NCT04279418|Dietary Supplement|Mixed functional foods supplementation|In this project, taking the method of random, double blindness and control, participants in the mixed functional foods group will take functional foods with main compositions of ginsenoside, green tea polyphenols and marine collagen peptide for three months. After that, neuropsychological tests and neuroimaging biomarkers will be compared between functional food group and placebo group.
15820643|NCT04279418|Dietary Supplement|Placebo|In this project, taking the method of random, double blindness and control, participants in the placebo group will take placebo for three months. After that, cognitive changes and neuroimaging biomarkers will be compared between functional food group and placebo group.
15820644|NCT04279405|Drug|YY-20394|YY-20394 80mg tablet administered orally once daily
15820645|NCT04279392|Drug|Zoledronic Acid 5 mg/Bag 100 ml Inj|Zoledronic acid infusion
15820646|NCT04279392|Drug|Placebos|Saline infusion
15820647|NCT04279379|Drug|Sintilimab|200mg d1,ivdrip, repeated every 3 weeks
15820648|NCT04279379|Drug|Decitabine|10mg d1-5, ivdrip,repeated every 3 weeks
15820649|NCT04279366|Behavioral|Lifestyle intervention|The 14 week courses takes place at a Danish folk high school (Ubberup), specialized in lifestyle interventions targeting a 10% weight loss. Adult individuals with obesity sign up for the course. They stay at the School for the whole course period and the total cost amounts to 300-400 Euros per week plus loss of income.
15820650|NCT04279353|Other|Mindfulness Based Intervention|this intervention is a 4 weeks program with logbook and follow up during intervention
15820651|NCT04279314|Drug|Trofinetide|Trofinetide solution of 30-60 mL based on subject's weight at Baseline, administered twice daily by mouth or gastrostomy tube (G-tube)
15820652|NCT04279288|Device|Hilotherm mask|a cooling mask used to treat localized swelling and bleeding
15820653|NCT04279275|Other|SURVEY|QUESTIONAIRRE
15820654|NCT04279262|Other|attendance by community first responders for medical emergencies|The investigators will purposively sample patients, relatives, and ambulance staff identified from records of patients who have been attended by a CFR in a rural location in the previous six months. Where possible the investigators will interview patients, relatives, CFRs and ambulance staff attending the same event. GPs will be purposively sampled from rural areas of the ambulance services involved. Investigators will recruit a maximum variation sample of patients (according to age, sex, condition, and ethnicity), ambulance staff (sex, experience, ethnicity and role), CFR (sex, ethnicity, length of experience, skill level) and CFR scheme leads (independent charity and ambulance trust overseen schemes).
15820655|NCT04279249|Other|HEPA Air Filtration|2 HEPA air filters placed in home (one in bedroom, one in living room) for 30 days
15820656|NCT04279249|Other|Sham HEPA Air Filtration|2 HEPA air filter devices with filter removed placed in home (one in bedroom, one in living room) for 30 days
15820657|NCT04279236|Other|Abbreviated Profile Hearing Aid Benefit (APHAB)|An intervention in this study which is outside the routine clinical practice of the clinics is the APHAB questionnaire that will be completed by the subjects on 2 occasions.
15820658|NCT04279236|Other|Glasgow Benefit Inventory (GBI)|An intervention in this study which is outside the routine clinical practice of the clinics is the GBI questionnaire that will be completed by the subjects on 2 occasions.
15820659|NCT04279236|Other|Additional follow-up visit|There is an additional follow-up visit after surgery (compared to the routine clinical practice of the surgeons/clinics).
15820660|NCT04279223|Procedure|Laparoscopic cholecystectomy|Comparative study to investigate the effect of small-scale trocar use on the development of trocar site hernia in laparoscopic cholecystectomy
15820661|NCT04279210|Device|Platelet-rich plasma|The RegenKit-THT (RegenLab SA, Switzerland) was used to separation of plasma and blood cells. 3mL PRP was extracted from the bottom of the plasma. PRP was injected into anterior vaginal wall, near external urethral sphincter, and into endopelvic fascia.
15820662|NCT04279197|Drug|Fuzheng Huayu Tablet|FZHY, administration: 0.4g/tablet, 1.6g/time, 3 times/day, oral; medicine to be taken after meals.
15820663|NCT04279197|Drug|Vitamin C tablets|Vitamin C tablets, administration: 0.2g/time, 3 times/ day, oral；
15820664|NCT04279197|Other|Placebo|Placebo , administration: 0.4g/tablet, 1.6g/time, 3 times/day, oral; medicine to be taken after meals.
15820665|NCT04279197|Other|respiratory function rehabilitation training|Health exercise, once a day
15820666|NCT04279171|Diagnostic Test|Greyson NDE scale|Questionnaire to detect occurence of NDE. A NDE is identified if score > or = 7/32
15820667|NCT04279171|Diagnostic Test|DES dissociation scale|Screening for dissociative symptoms
15820668|NCT04279171|Diagnostic Test|WHOQOL-SRPB|WHOQOL-SRPB is an instrument developed to evaluate how spirituality, religiosity and personal beliefs (SRPB) are related to quality of life in health and health care.
15820669|NCT04279171|Diagnostic Test|cerebral magnetic resonance imaging|Types of images to be acquired: T1, T2, Diffusion Weighted Imaging-DWI, Fluid Attenuated Inversion Recovery and spectroscopy
15820670|NCT04279158|Behavioral|"experience 1 The negative priming task"|The targets are presented to the subject on a computer screen. The subject must make an eye or hand movement toward the target and ignore the distracters.
15820671|NCT04279158|Behavioral|"experience 2 Stop signal task"|The targets are presented to the subject on a computer screen. The subject must make an eye movement towards this target. Sometimes a stop signal will appear and the subject will have to avoid to look at the target
15820672|NCT04279158|Behavioral|"experience 3 Anti-saccades"|The targets are presented to the subject on a computer screen. The subject must make an eye movement toward this target. Sometimes an instruction will ask the subject to look at the opposite of the target
15820673|NCT04279145|Device|swan ganze catheter /echocardiography|"Right heart catheterization and mixed venous blood samples will be obtained for ABG, biomarkers (troponin , uric acid and micro RNA).
~Each subject will have echocardiography, 6 MWD, clinical functional class and blood sample at the day of right heart catheterization or at least less than week of right heart catheterization"
15820674|NCT04279132|Behavioral|POSTOPERATIVE COGNITIVE DYSFUNCTION|NEURON SPECIFIC ENOLASE LEVELS IN LUMBAR DISC HERNIECTOMY WITH GENERAL ANESTHESIA MODALITIES
15820675|NCT04279119|Drug|ARQ-151- cream 0.3%|ARQ-151 cream 0.3% applied to chronic plaque psoriasis lesions once a day for 2 weeks
15820676|NCT04279106|Procedure|0.05%chlorhexidine mouthwash|All subjects were instructed to rinse once a day, in the morning, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.
15820677|NCT04279106|Procedure|0.05% sodium fluoride mouthwash|All subjects were instructed to rinse once a day, in the morning, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.
15820678|NCT04279106|Procedure|alcohol free essential oils mouthwash|All subjects were instructed to rinse once a day, in the morning, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.
15820679|NCT04279106|Procedure|Placebo|All subjects were instructed to rinse once a day, in the morning, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.
15820680|NCT04279093|Other|No intervention, but participants will use a smartphone app daily to complete the EPDS|No intervention, but participants will use a smartphone app daily (ClinTouch DAWN-P) to complete the Edinburgh Postnatal Depression Scale
15820681|NCT04279080|Other|low anterior resection syndrome evaluation|evaluation of postoperative functional bowel outcome
15820682|NCT04279067|Device|BCI-FES dorsiflexion therapy|"BCI technology enables direct brain control of external devices such as assistive devices and prostheses by translating brain waves into control signals. When BCI systems are integrated with functional electrical stimulation (FES) systems, they can be used to deliver a novel physical therapy to improve movement after stroke. The automated software will analyze the data to generate and calibrate a BCI decoder. In the online phase, the subjects will perform 20-25 BCI-FES runs. In each run, subjects will follow 10 alternating epochs of 10-s long idling/dorsiflexion textual cues, and respond by either idling or attempting dorsiflexion to elicit BCI-FES mediated contractions of the TA muscle."
15820683|NCT04279067|Behavioral|Physiotherapy one hour|This will consist of a standardized regimen of activities typical of conventional post-stroke gait therapy, including passive/active range of motion exercises (to reduce/prevent excessive plantarflexor contractures), lower-extremity muscle strengthening, and a progression from treadmill to overground walking exercises. A total of 12 sessions will be performed at 3x/week.
15820684|NCT04279067|Behavioral|Physiotherapy two hours|This will consist of a standardized regimen of activities typical of conventional post-stroke gait therapy, including passive/active range of motion exercises (to reduce/prevent excessive plantarflexor contractures), lower-extremity muscle strengthening, and a progression from treadmill to overground walking exercises. A total of 12 sessions will be performed at 3x/week.
15820685|NCT04279054|Drug|Morphine Sulfate 150 mcg|Use of 150mcg of morphine sulfate for neuraxial block (dosing difference)
15820686|NCT04279054|Drug|Morphine Sulfate 50mcg|Use of 50mcg of morphine sulfate for neuraxial block (dosing difference)
15820687|NCT04279041|Procedure|root canal preparation|root canal preparation
15820688|NCT04279028|Behavioral|Adapted CBT|"ACBT is derived from traditional CBT principles, but eliminates the text-heavy requirements. Traditional CBT incorporates the use of complex worksheets and a lengthy workbook, whereas ACBT replaces these skill learning activities with simpler, straightforward exercises that are practiced in session along with the therapist. This real world practice eliminates the need for reading and writing as part of CBT while simultaneously recapitulating how the patient would actually implement CBT procedures. In session exercises will mirror that of standard CBT practices. For example, they could include lessons in goal setting, distinguishing situations, moods, and thoughts, and experiments to test underlying assumptions. Participants will be assigned paper-free homework assignments."
15820841|NCT04277741|Dietary Supplement|Control bar|The control group will consume one native wheat starch bar per day.
15820842|NCT04277728|Diagnostic Test|hypoperfusion-hypodensity mismatch|hypoperfusion-hypodensity mismatch on computed tomography
15820689|NCT04279028|Behavioral|Standard CBT|CBT involves the therapist and client working to identify and change negative beliefs and thoughts, replacing them with more accurate and balanced thoughts. CBT for Depression will be conducted according to standard manuals and incorporate the use of a common workbook used within CBT sessions. As per standard practice, participants will be assigned worksheets from their workbook used both in session and as homework assignments.
15820690|NCT04279015|Procedure|Kinesio tape procedure|"Conventional rehabilitation treatment: Hotpack, ultrasound, conventional TENS and exercise for neck pain.
~Kinesio taping procedure: Inhibition technique with 15-25% tension to the upper trapezius muscle with I tape to reduce pain and muscle spasm, to support the weak muscles, Facilitation technique with Y-band with 15-35% tension to the cervical paravertebral muscles, and X-band with 15-35% tension to the rhomboideus major muscle technique and the correction technique was applied to the region where the individual defined the most pain and tenderness in palpation by using the star application."
15820691|NCT04279002|Other|Brief 15-question questionnaire|Questionnaire is mailed retrospectively to the respiratory rehabilitation program and aimed at targeting 17 psycho-social traits. Response time is estimated at 10 minutes
15820692|NCT04278989|Drug|Anti-tumor B|1,200 mg, three times a day for seven to 28 days (dependent on scheduled surgery).
15820693|NCT04278989|Drug|Placebos|Placebos taken seven to 28 days (dependent on scheduled surgery).
15820694|NCT04278976|Other|Implementation of CoBaTrICE|"The implemention of CoBaTrICE will include the three following essential elements:
~Training the trainers. In order to provide high quality feedback to guide development of competence, tutors will receive a course in formative assessment, debriefing techniques, and effective feedback.
~Workplace-based assessment (WbA) to promote learning and to guarantee that the predefined competences and skills are effectively acquired. Current Wb observation methods such as mini-clinical examination exercise, direct observation of procedural skills and multisource-feedback 360º will be used.
~The use of an electronic portfolio specifically created as a personal collection of training documents that includes the record of formative assessments, activities, and the levels of competence achieved. The portfolio will help monitor progress of trainee's skills development and learning experiences contributing to an effective assessment, self-reflection and control of the learning process."
15820695|NCT04278963|Drug|YinHu QingWen Decoction|YinHu QingWen Decoction (Granula) consits of 11 Chinese herbal medicine as Honeysuckle, Polygonum cuspidatum, Schizonepeta, Longspur epimedium, etc. The decoction granula will be dissolved into 600ml decoction and divided to 3 times (once with 200ml). It will be given a 200ml per time, three times a day, for 10 days.
15820696|NCT04278963|Drug|YinHu QingWen Decoction(low dose)|This intervention is given as 10% dose of YinHu QingWen Decoction (Granula).The granula will be dissolved into 600ml decoction and divided to 3 times (once with 200ml). It will be given a 200ml per time, three times a day, for 10 days.
15820697|NCT04278963|Other|Chinese medicine treatment|This intervention will be given with Chinese medicine decoction granula based on the symptoms differentiation of the patients for 10 days.
15820698|NCT04278963|Other|standard western medicine treatment|Standard western medicine treatment is according to the protocol of treatment of CoVID-19 infection according to guideline appoved by National Health Commission of China.
15820699|NCT04278950|Drug|Povidone-Iodine|For the PVP-I group, the final concentration of available iodine in the solution will be 0.01%, (from diluting 10% PVP-I solution), as previously demonstrated to be below ciliotoxic levels of 1.25% and greater than 0.01% which is the lower limit of active potency.
15820700|NCT04278950|Drug|Placebos|The placebo will be 2.5mL of saline with brown food coloring.
15820701|NCT04278937|Drug|Azithromycin Tablets|one tablet orally twice daily for three days in 3 courses at 14 weeks, 24 weeks and 32 weeks
15820702|NCT04278924|Drug|Placebo|TAK-079 placebo-matching SC injection.
15820703|NCT04278924|Drug|TAK-079|TAK-079 SC injection.
15820704|NCT04278911|Diagnostic Test|MMSE and MoCA|This is an observational study. All the patients evaluate with MMSE (Mini-mental State Examination) and MoCA (Montreal Cognitive Assessment), and investigate the incidence and characteristics of cognitive and MACE
15820705|NCT04278898|Drug|N-Acetylcysteine|N-acetylcysteine Single Dose 2700 mg taken orally
15820706|NCT04278885|Drug|Lanadelumab|300mg Lanadelumab s.c. administration every 2 weeks
15820707|NCT04278872|Drug|SJX-653|administered orally once daily
15820708|NCT04278872|Drug|Placebo|administered orally once daily
15820709|NCT04278859|Biological|Drug: JS004, Recombinant humanized IgG4κ monoclonal antibody specific to BTLA for injection Intravenous infusion|Drug: JS004, Recombinant humanized IgG4κ monoclonal antibody specific to BTLA for injection Intravenous infusion
15820710|NCT04278846|Drug|Depofoam bupivacaine|The study drugs will be administered into the right and/or left breast of each patient 30 minutes prior to the creation of the subpectoral muscle pocket.
15820711|NCT04278833|Drug|Triamcinolone or Betamethasone|Image guided intra-articular, peri-tendinous, or intra-bursal corticosteroid injection
15820712|NCT04278833|Drug|Dexamethasone|Image guided intra-articular, peri-tendinous, or intra-bursal corticosteroid injection
15820713|NCT04278820|Drug|TQA3526|Tablet(s) administered orally once daily
15820714|NCT04278820|Drug|Placebo to match TQA3526|Tablet(s) administered orally once daily
15820715|NCT04278807|Procedure|Regional Anesthesia - Nerve Blocks|Regional Anesthesia and ultrasound-guided nerve blocks
15820716|NCT04278794|Other|Transitional Care Stroke Intervention (TCSI)|"Core components:
~Comprehensive Hospital Discharge Plan. The Care Coordinator will meet with staff in the in-patient unit along with patients and their caregivers to develop and implement a comprehensive discharge plan.
~Structured home visits and telephone support. As part of the structured home visits and telephone support, a member of the IP team will provide up to 6 home visits over 6 months. The team will provide: screening and assessment; medication review and reconciliation; self-management support; education; and caregiver assessment.
~Monthly IP case conferences. 6 monthly IP team case conferences will be held to discuss goals identified by the patient, collectively develop a plan of care, and identify needs.
~Linkages to services. Facilitate timely follow-up with the primary care provider and build relationships with local health and social service providers. These referrals and links will provide the foundation for continued use post-intervention."
15820717|NCT04278781|Drug|AG-120|AG-120 500 mg orally once daily days 1-28 of a 28-day cycle
15820847|NCT04277689|Procedure|Brain signal data collection|Collection of speech related electrophysiological data at the time of DBS.
15820718|NCT04278768|Drug|CA-4948|CA-4948 is formulated as a tablet for oral administration for BID dosing in consecutive 28-day cycles. CA-4948 is a novel small molecule inhibitor of interleukin-1 receptor-associated kinase 4 (IRAK4),IRAK4 kinase plays an essential role in toll-like receptor (TLR) and interleukin-1 receptor (IL-1R) signaling pathways and these pathways are frequently dysregulated in non-Hodgkin's lymphoma and AML/MDS malignancies.
15820719|NCT04278768|Drug|Azacitidine|Azacitidine is a chemotherapy drug. Azacitidine 75 mg/m2 intravenous (IV) or subcutaneously (SC) will be administered as 7 doses on a 28-day Cycle.
15820720|NCT04278768|Drug|Venetoclax|Ventoclax is B-cell lymphoma-2 (BCL-2) inhibitor. Venetoclax will be administered at 100 mg orally (Day 1) per the product label at the same time each day with a ramp up over 3 days to 400 mg for 21days of a 28-day Cycle. Second and subsequent cycles start with target dose level.
15820721|NCT04278768|Drug|CA-4948|CA-4948 is formulated as a tablet for oral administration for BID dosing for 21 days (Days 1-21) of a 28-day Cycle.
15820722|NCT04278755|Drug|Drospirenone-Ethinyl Estradiol Oral Tablet|3 Mg-0.03 Mg continuous daily Drospirenone-Ethinyl Estradiol.
15820723|NCT04278742|Other|Patient education|Using a collaborative approach to engage patients in their own care, allowing patients to continue to have full control of their treatment. The clinician and patient co-creates the treatment plan.
15820724|NCT04278729|Drug|Apixaban 5 MG|1 - 5 mg tablet taken orally twice a day
15820725|NCT04278716|Other|Safe return to play checklist|this objective checklist will be utilized by the physical therapy staff and surgeon to determine whether an athlete is safe to return to their sport
15820726|NCT04278703|Drug|Oxycodone|Patients will be given a prescription for 15 opioid tablets for post-operative pain
15820727|NCT04278703|Drug|Oxycodone|Patients will be given a prescription for 25 opioid tablets for post-operative pain
15820728|NCT04278703|Drug|oxycodone|Patients will be given a prescription for 35 opioid tablets for post-operative pain
15820729|NCT04278690|Other|HELPix|HELPix parents will receive usual care as above, after which trained staff will generate HELPix patient-/regimen-specific medication instruction sheets and review them with the parent. Instruction sheets include optimized instructions (mL-only, doses appropriately rounded, visuals of recommended tool (e.g. 1-mL syringe best for doses of <1 mL), explicit frequency information (e.g. 'morning and night' instead of '2x/day') reinforced by pictograms (e.g. sun/moon icons)). For each medication, staff will: 1) review the dose (refer to the pictographic dose diagram, which illustrates optimal dosing tool filled to correct amount), 2) demonstrate the dose using optimal dosing tool, 3) ask parent to 'teachback'/'showback' dose (e.g. parent shows provider how much they would give by pulling back plunger on syringe to right level), 4) provide optimal dosing tool for the parent to take home. We anticipate this process will take ~5-10 minutes.
15820730|NCT04278690|Other|HELPix+Tech|After parent receives usual care and HELPix , trained staff will walk parent through the app on-boarding process to overcome initial barriers to use. Steps: 1) Parent texted link to personalized on-line instructions. 2) Parent clicks link to app. For each medicine: A. Dosing module with optimized instructions (c/w HELPix); parent teachback/showback of dose B. Frequency module supports simplified, explicit intervals (e.g. 'morning and night'), parent chooses convenient times (text reminders sent based on preferences). Time for TECH depends on # medicines and parent baseline knowledge; structured protocol used to see # teachback rounds needed .
15820731|NCT04278677|Dietary Supplement|melatonin|Melatonin capsules to be taken for 6 weeks
15820732|NCT04278651|Drug|Ferumoxytol|510mg infusion x 2 doses 3-8 days apart
15820733|NCT04278651|Drug|Ferrous Sulfate|325mg oral twice daily
15820734|NCT04278638|Radiation|IORT|IORT in surgery of laryngocarcinoma
15820735|NCT04278638|Procedure|surgery|total laryngectomy or hemilaryngectomy
15820736|NCT04278638|Radiation|External radiotherapy|External radiotherapy
15820737|NCT04278625|Drug|Acetaminophen|IV acetaminophen given as part of standard of care.
15820738|NCT04278612|Other|Quality improvement intervention to strengthen health service provision|Quality improvement intervention comprising of regular improvement meetings based at clinics.
15820739|NCT04278599|Drug|Oral Zinc supplementation|In the test group, the patients will be administered Zinc Acetate tablets (equivalent to 30 mg of elemental zinc/day) for 6 weeks from the baseline. They will also be will be administered, topical corticosteroid paste- Triamcinolone acetonide- 0.1%, to be applied thrice a day till the lesions disappeared and the dosage will be tapered accordingly.The patients will be instructed to take the tablets and apply the paste after meals.The patients will be kept on a monthly follow-up for 3 months.
15820740|NCT04278599|Drug|Oral placebo supplementation|In the control group, the patients will be administered Placebo tablets for 6 weeks from the baseline. They will also be administered, topical corticosteroid paste- Triamcinolone acetonide- 0.1%, to be applied thrice a day till the lesions disappeared and the dosage will be tapered accordingly.The patients will be instructed to take the tablets and apply the paste after meals.The patients will be kept on a monthly follow-up for 3 months.
15820741|NCT04278586|Behavioral|Live-Online M-ROCC|"LDM (Low-Dose Mindfulness): A 4-wk intro mindfulness program for OUD, 50-60 min/week including explicit training in use of mobile mindfulness apps, with rolling admission and ascending practice dose ladder.
~MTPC (Mindfulness Training for Primary Care): An eight-week intensive mindfulness group with ascending practice dose ladder and skill integration over 16 weeks with 60 minutes/wk.
~MCS (Mindfulness Maintenance Check-in Support): Ongoing weekly mindfulness group with check-in and reminders, leveraging mobile mindfulness apps and motivational counseling for graduates of LDM for 50-60 mins/wk.
~After completion of the LDM group, participation in various levels is fluid based on patient motivation, choice, and readiness."
15820742|NCT04278586|Behavioral|Live-Online Control|A time- and attention-matched live online control group. The manualized control intervention developed for the basic group-based opioid treatment group in primary care uses 16 core modules and 8 elective modules that are common to eclectic approach in treatment as usual addiction recovery groups (including engagement and group development activities with a mix of basic CBT skills, twelve-step facilitation, community reinforcement, and motivational interviewing). As an active group control, this method will help to isolate mindfulness as the putative mechanism of action by controlling for the therapeutic aspects of group without any reference to mindfulness.
15820743|NCT04278573|Drug|Vitamin D3|Intralesional injection of 0.3 ml 40,000 IU/ml vitamin D3 into one wart
15820744|NCT04278573|Drug|Placebo|0.3 ml injection of sterilized propylene glycol: dehydrated alcohol (9:1 ratio) with no active study ingredient
15820745|NCT04278560|Device|Transcranial direct current stimulation (tDCS)|tDCS will be delivered via six gel electrodes with placement and current parameters optimized based on a standard brain to maximize the average normal component of the generated electric field over the left dlPFC. Current delivered by anyone electrode will never exceed 2.0 mA; the total amount of current from all electrodes will not exceed 4 mA. Each 20-minute session will begin and end with a 60-second ramp up/down of current amplitude to maximize comfort.
15820746|NCT04278560|Device|Sham stimulation|An 'active' sham will be used in which very low-level currents are transferred between the same electrodes used in the active condition throughout the 20-minute session. However, currents will be designed to mimic the cutaneous sensations induced by tDCS yet not significantly influence cortical tissue.
15820747|NCT04278560|Behavioral|Behavioral intervention to increase physical activity|Study staff will complete face-to-face and telephone counseling sessions with each participant, tailored to their state of readiness to increase physical activity levels. The participant will be provided with a goal to increase their average daily step count by 20% from baseline. The staff member will review the participant's stated barriers to exercise and provide them with a list of strategies they may use to augment their step counts throughout each day. Bi-weekly face-to-face counseling sessions will then be completed to review and discuss activity performance and answer any questions the participant may have regarding their efforts to increase physical activity.
15820748|NCT04278547|Diagnostic Test|ELISPOT IFN-γ assay|"ELISPOT IFN-γ diagnostic test: Evaluation of specific cellular immune response against the IE-1 antigen and the CMV pp65, using the technique ELISPOT IFN-γ and individualize the preventive strategy according to the result. In patients with a ELISPOT of low risk will be made advance therapy (preemptive therapy) guided by PCR of CMV In patients with a high risk ELISPOT, universal prophylaxis with valganciclovir will be performed oral (900 mg / 24h) or intravenous ganciclovir (5-10 mg / Kd / day) in case the oral route is not available."
15820749|NCT04278534|Other|Educational Intervention|Complete radiation therapist-led education module using virtual reality
15820750|NCT04278534|Other|Educational Intervention|Receive the usual verbal and written education materials
15820751|NCT04278534|Other|Educational Intervention|Complete radiation therapist-led face-to-face education module
15820752|NCT04278534|Other|Survey Administration|Ancillary studies
15820753|NCT04278521|Device|Transcranial Magnetic Stimulation|Transcranial magnetic stimulation uses a rapidly changing magnetic field to induce current in brain tissue non-invasively. It is common procedure in both clinical and research settings, and it has well established guidelines for safe an ethical use which maximize safety for all subjects.
15820754|NCT04278508|Drug|Progesterone|To determine if different serum P levels on FET day are associated with different clinical pregnancy rates (CPR)
15820755|NCT04278495|Drug|Cozaar (Losartan Potassium 25mg)|Cozaar (Losartan Potassium 25mg)
15820756|NCT04278495|Drug|Placebo|Placebo
15820757|NCT04278482|Dietary Supplement|Dietary supplement, DHA or Placebo|Consumption of 2 capsules per day of the dietary supplement, DHA or Placebo
15820758|NCT04278469|Drug|Chemotherapy Drugs, Cancer|Clinical high and genomic low Hormone Receptor-positive early breast cancer patients with or without adjuvant chemotherapy
15820759|NCT04278456|Behavioral|postpartum depression|melatonin levels in c-sections with different anesthesia modalities.
15820760|NCT04278430|Device|transcranial direct current stimulation|"The tDCS stimulator (ActivaDose II tDCS Device; IOMED Inc., Salt Lake City, USA) is a standardized instrument used and tested in children. Two tDCS electrodes of dimensions 3 x 3 were used for the brain stimulation. The electrodes were inserted into a wet saline sponge."
15820761|NCT04278430|Device|Sham tDCS|Five children with LSIH were randomly allocated to this group. All participants received sham tDCS for 3 weeks on alternate days and completed 10 treatment sessions. The sham tDCS followed preparatory procedures similar to that used for the experimental group, except that the device was disconnected after the initial increase of the current. Children usually started the activity without noticing that the device was disconnected. The children were assessed at baseline, during the 5th and 10th sessions, and during a follow-up that was scheduled for 4 months later.
15820764|NCT04278404|Drug|The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:|The prescribing of drugs to children is not part of this protocol. Participants will receive DOIs as prescribed by their treating provider.
15820765|NCT04278391|Drug|DWJ1421|1 tablet administered in fasting condition
15820766|NCT04278391|Drug|DWC201903|1 tablet administered in fasting condition
15820767|NCT04278378|Dietary Supplement|Riboflavin|1.6 mg riboflavin / day for 24 weeks
15820768|NCT04278378|Dietary Supplement|Folic acid|0.4 mg folic acid / day for 24 weeks
15820769|NCT04278378|Dietary Supplement|Placebo|
15820770|NCT04278365|Behavioral|Positive affect training|Behavioral training involving position emotion enhancement
15820771|NCT04278352|Behavioral|Mindfulness Based Relapse Prevention|The intervention is a group skills training program that is delivered once weekly for eight weeks. Content focuses on mindfulness and cognitive-behavioral relapse prevention skills, including psychoeducation, experiential exercises, and between session homework assignments.
15820772|NCT04278339|Other|Evoked Related Potentials|Evoked Related Potentials are measured by means of electroencephalography. During this measure, 2 informatic task will be performed to evaluated evoked related potentials.
15820773|NCT04278326|Procedure|Vaginal Biopsy|"Vaginal biopsies
~Additional cervical and vaginal biopsies
~Non invasive cervico-vaginal swab like a smear"
15820774|NCT04278313|Procedure|PRP - Platelet Rich Plasma|Using a sterile vacutainer technique two 8 ml samples of whole blood is drawn into two Regen Lab A-PRP vacutainers with gel separator and citrate. Invert the tube to mix with citrate. The whole blood undergoes two centrifugations, once for 3 minutes and again for 5 minutes. Using a 20-gauge 6-inch spinal needle 2 ml of Platelet POOR Plasma will be drawn off the supernatant from each tube to leave 2.5 ml of Platelet Rich Plasma in the tube. The tube is inverted several times to suspend the platelet pellet. The prepared plasma labeled with the participants name and randomization code will be transported to the procedure room.
15820775|NCT04278313|Procedure|PPP - Platelet Poor Plasma|Using a sterile vacutainer technique two 8 ml samples of whole blood is drawn into two Regen Lab A-PRP vacutainers with gel separator and citrate. Invert the tube to mix with citrate. The whole blood undergoes two centrifugations, once for 3 minutes and again for 5 minutes. Using a 20-gauge 6-inch spinal needle 2 ml of Platelet POOR Plasma will be drawn off the supernatant from each tube. The prepared plasma will be transported to the procedure room. The prepared plasma labeled with the participants name and randomization code will be transported to the procedure room.
15820776|NCT04278300|Biological|blood sampling|dosage of omega 3 polyunsaturated fatty acids, search for age-related macular degeneration susceptibility genese
15820777|NCT04278300|Biological|faecal sampling (optional)|analysis of the microbiota by DNA sequencing
15820778|NCT04278287|Radiation|Radiotherapy|59.92Gy and 2.14Gy in 28 fractions to PGTV and 50.4Gy and 1.8Gy in 28 fractions 5 days every week in 5.5 weeks.
15820779|NCT04278287|Drug|Albumin-Bound Paclitaxel|100mg/d weekly,repeatedly on the first day,by intravenous infusion in 5-6 weeks.
15820780|NCT04278287|Drug|Cisplatin|25mg/m2 weekly,by intravenous infusion in 5-6 weeks.
15820781|NCT04278274|Procedure|artificial intelligence prediction system|The tumor ROI in the post- neoadjuvant treatment MRI images will be manually delineated, and further subjected to the AI prediction system arm to verify the predictive accuracy of this AI prediction system in identifying the pCR individuals from non-pCR patients with LARC.
15820782|NCT04278274|Procedure|the radiologists|The enrolled patients will be assigned to the trained experienced radiologists to evaluate their predictive accuracy in identifying the pCR individuals from non-pCR patients
15820783|NCT04278261|Procedure|Focal therapy(Irreversible Electroporation)|Irreversible electroporation will be performed via the perineum with the guidance of ultrasound under general anaesthesia to the patient with localized prostate cancer
15820784|NCT04278261|Procedure|Radical prostatectomy|Radical prostatectomy
15820785|NCT04278248|Biological|23-Valent Pneumococcal Polysaccharide Vaccine|1 dose according to age of subjects. Single intramuscular dose contains 0.5ml 23-Valent Pneumococcal Polysaccharide Vaccine.
15820786|NCT04278235|Drug|Elezanumab|Solution for intravenous (IV) infusion
15820787|NCT04278222|Drug|Anlotinib Plus Toripalimab|Anlotinib 12mg oral administration daily d1-d14, q3w; Toripalimab 240mg iv drop d1, q3w
15820788|NCT04278209|Other|Breakfast 1|Participant will receive Breakfast 1
15820789|NCT04278209|Other|Breakfast 2|Participant will receive Breakfast 2
15820790|NCT04278209|Other|Water|Participant will receive water
15820791|NCT04278196|Other|AI-Box|AI-box is a system fixed adjacent to magnet controlled capsule endoscopy. Patients who accept the check of magnet controlled capsule endoscopywill be enrolled .
15820792|NCT04278170|Other|no attempt was made to patients|no attempt was made to patients
15820793|NCT04278157|Behavioral|Socio-Cognitive Behavioral Therapy for Suicidal Behavior (SCBT-SB)|The SCBT-SB is a manualized and flexible intervention that uses a modular approach to the treatment of adolescent suicidality. After the first mandatory module (Crisis module), and at the end of each subsequent module, the therapist works with the teen and caregivers to determine the next one. The Crisis Module is fixed and represent the intervention core skills with 9 sessions. The optional coping skills modules include Thoughts, Emotional Regulation, Family Communication, Social Interaction, Activity, Trauma, and Substance Use.
15820794|NCT04278157|Behavioral|Treatment as Usual|Therapy that typically consist of eclectic individual therapy including CBT, emphasizing psychoeducation and providing support, with occasional conjoint parent sessions or individual caregiver sessions. The treatment as usual primarily focuses on generating solutions to the adolescent and caregivers most urgent concerns.
15820795|NCT04278144|Drug|BDC-1001|Immune stimulating antibody conjugate (ISAC), consisting of an anti-HER2 monoclonal antibody conjugated to a TLR 7/8 dual agonist
15820796|NCT04278144|Drug|Pembrolizumab|Programmed death receptor-1 (PD 1)-blocking antibody
15820797|NCT04278131|Drug|BS01|Non-replicating, rep/cap-deleted, recombinant adeno-associated virus vector expressing an enhanced light-sensitive channelrhodopsin gene (ChronosFP)
15820798|NCT04278118|Radiation|Hypofractionated Radiation Therapy|Undergo hypofractionated proton or photon radiation therapy
15820799|NCT04278118|Radiation|Photon Beam Radiation Therapy|Undergo hypofractionated proton or photon radiation therapy
15820800|NCT04278118|Radiation|Proton Beam Radiation Therapy|Undergo hypofractionated proton or photon radiation therapy
15820801|NCT04278118|Other|Quality-of-Life Assessment|Ancillary studies
15820802|NCT04278118|Other|Questionnaire Administration|Ancillary studies
15820803|NCT04278105|Device|HD-tCES|The positions of the lesion side primary motor cortex were defined as C3/C4 according to the international 10-20 system of electroencephalograms. HD-tCES will be applied for 20 minutes at an intensity of 1.0 mA direct current stimulation and a specific-added waveform each time, 3 times a week, lasting for 4 weeks.
15820804|NCT04278105|Device|Sham HD-tCES|The positions of the lesion side primary motor cortex were defined as C3/C4 according to the international 10-20 system of electroencephalograms. Sham HD-tCES will consist of a 5-second ramp up to 1.0 mA direct current stimulation and a specific-added waveform followed immediately by a 5-second ramp down, no current in the middle 19 minutes 40 seconds, and a ramp-up and ramp-down period during the last 10 seconds.
15820805|NCT04278105|Other|Upper extremity rehabilitation|Upper extremity rehabilitation programs will be selected and graded in accordance with each patient's upper extremity function and specific aims of activities of daily living. Upper extremity rehabilitation will be provided for 30 minutes each time, 3 times a week, lasting for 4 weeks.
15820806|NCT04278092|Drug|Paclitaxel|Paclitaxel 175 mg/m2, q21
15820807|NCT04278092|Drug|Cetuximab|Cetuximab 400mg/m2 loading dose followed by weekly 250mg/m2
15820808|NCT04278079|Procedure|Pars Plana Vitrectomy with Internal Limiting Membrane peel|Pars plana vitrectomy with staining and peeling of internal limiting membrane
15820843|NCT04277715|Behavioral|Parent training|Parents will learn evidence-based techniques for increasing support and decreasing accommodation of children's chronic symptoms.
15820844|NCT04277702|Drug|Montelukast 10mg|Oral administration of 10mg of montelukast daily for 12 months
15820845|NCT04277702|Procedure|Endovascular treatment|Percutaneous transluminal angioplasty combined with bare-metal stenting of lower limbs arteries
15820846|NCT04277702|Drug|Standard anti-platelet treatment|Standard antithrombotic treatment for patients undergoing endovascular procedures
15820809|NCT04278053|Dietary Supplement|inositol-stabilized arginine silicate|Participants were asked to complete the experimental protocol in a 2-hour fasted state. Each participant's brachial artery FMD was assessed twice during each trial, once before supplement ingestion, and again 60 minutes post-ingestion. Male participants were required to wait for a minimum of seven days between trials as a supplement washout period. Female participants reported for supplement trials outside of their follicular phase of the menstrual cycle so that results were not confounded by changes in serum estradiol, which can significantly attenuate flow-mediated dilation. Sixty minutes after supplement consumption, each participant was asked which supplement they thought they had consumed. Participants were also asked whether they experienced any adverse side effects.
15820810|NCT04278040|Drug|Melphalan|Inhalations with low doses of Melphalan for 5 consequent days
15820811|NCT04278027|Behavioral|Cognitive Remediation Therapy|"CIRCuiTS is a web-based computerised CR therapy, delivered by a therapist but supplemented with independent sessions to facilitate massed practice. It targets metacognition, particularly strategy use, in addition to providing massed practice of basic cognitive functions. The therapist facilitates motivation, metacognitive and strategy development and generalisation of learning by encouraging the participant to learn about and regulate their cognitive performance and to transfer this learning to meet real-world goals. Therapists provide additional scaffolding for CR tasks to ensure consistent successful performance. Independent sessions involve carrying out cognitive tasks allocated by the therapist to ensure scaffolded learning (Reeder et al.2017)"
15820812|NCT04278014|Procedure|ultrasound-guided continuous sciatic block with longitudinal approach|ultrasound-guided continuous sciatic block with longitudinal approach
15820813|NCT04278001|Device|Dual 24-hour ABPM|Dual 24-hour ABPM with both the SOMNOtouch NIBP and a validated oscillometric 24-hour ABPM-device (SPACELABS 90217 / 90207).
15820814|NCT04277988|Device|Ultrasonography|Length of Posterior Longitudianl Ligament, Ligamentum Flavum and Interlaminar distance visible in paramedian longitudinal view during lumbar spine ultrasonography in cross legged position will be compared to standard sitting position.
15820817|NCT04277962|Device|Triton L and D system for estimation of blood loss at time of vaginal delviery|The Triton L&D system (Gauss Surgical, Inc., Menlo Park, CA) is an FDA-cleared mobile application on a tablet computer (iPad) that facilitates quantification of blood loss (QBL) by providing an easy to use process and user interface. Dry weights of all potential blood containing substrates are built-in to the device allowing batch weighing with automatic subtraction of dry weights. There is also a V-drape simulator accounting for collected fluids with automatic subtraction of a measured amount of amniotic fluid.
15820818|NCT04277949|Device|Erbium:YAG|Treatment with Erbium:YAG laser
15820819|NCT04277949|Drug|UV endonuclease from Micrococcus luteus|Application of topical DNA repair enzymes
15820820|NCT04277936|Drug|Levetiracetam 500 mg|Levetiracetam (LEV) regulates neuronal synaptic exocytosis and calcium-induced neurotransmitter release and has a therapeutic effect on the excitation-inhibition balance of the hippocampus.
15820821|NCT04277923|Drug|SMOFlipid|the lipid of all-in-one is less than 4g/kg.d
15820822|NCT04277923|Drug|Lipofundin|the lipid of all-in-one is less than 4g/kg.d
15820823|NCT04277910|Drug|MT2004|MT2004 oral capsules
15820824|NCT04277910|Drug|Placebo|Placebo oral capsules
15820825|NCT04277897|Drug|Hepenofovir Fumarate Tablets Single Dose|Oral Tablet; Subjects will receive either a single dose of Hepenofovir Fumarate Tablets on Day 1 only (SAD), once daily dosing of HTS starting on Day 1 through Day 7 (MAD).
15820826|NCT04277897|Drug|Placebo|Placebo to match Hepenofovir Fumarate Tablets
15820827|NCT04277897|Drug|Hepenofovir Fumarate Tablets Dose4|Oral Tabet; Subjects will receive Hepenofovir Fumarate Tablets Dose4 on Day 1 in fast condition, then receive Hepenofovir Fumarate Tablets Dose4 on Day 8 in fed condition.
15820828|NCT04277884|Drug|Firibastat|Oral administration 2×250 mg capsules bid
15820829|NCT04277884|Drug|Placebo|Oral administration 2 capsules bid
15820830|NCT04277871|Behavioral|Pelvic floor muscles training (PFMT) combined with yoga|All study participants were instructed to perform PFMT combined with yoga with an expectation of performing a 70-minute practice section 3 days in a week. All study participants received a booklet with menopause-related information, a booklet plus an instructional Digital Video Disc for PFMT and yoga practice.
15820831|NCT04277858|Drug|Docetaxel|Subjects will be treated with neoadjuvant docetaxel and cisplatin for 3 cycles. This is followed by transoral robotic surgery (TORS) and neck dissection as definitive treatment, reserving radiotherapy for salvage.
15820832|NCT04277845|Drug|Renalidomide, Velcade, Dexamethasone|Multiple Myeloma M-Proteins
15820833|NCT04277832|Diagnostic Test|Questionary|All patients will answer two different questionary (TUPAST, TOPAS 2)
15820834|NCT04277806|Behavioral|New Oral feeding process|From the beginning of 32 weeks, try oral feeding once a day, suck pacifier for 10 minutes before feeding. When she/he can finish 50% of the amount of one meal in consecutive two days, and there is no adverse events happened, then we will try oral feeding twice a day. In the same way, in the oral feeding she/he can finish 50% of this meal in consecutive two days, there is no adverse events happened, then we will try three oral feedings three times a day. We wil continue the process until the infant can be fully oral fed by herself/himself.
15820835|NCT04277793|Behavioral|Monitored self-guided problem solving|Problem Solving is a behavioral modification intervention focusing on the training of adaptive problem-solving skills in order to cope more effectively with everyday stressful events.
15820836|NCT04277780|Device|Continuous Glucose Monitoring Sensor|Placement of continuous glucose monitor sensor for 14 days. Instructions on how to peel off the sensor and mail it back to the clinician.
15820837|NCT04277780|Other|Diabetes Management Instructions|Instructions on checking fingerstick blood glucose and information on the required equipment including glucose test strips, lancets, and glucometer. Instructions on how to log blood glucose values onto the blood glucose log sheet for 14 days, and how to mail it back to the clinician.
15820838|NCT04277767|Diagnostic Test|observational|No intervention
15820839|NCT04277754|Other|Observational|To Observe and describe motor and visual development
15820840|NCT04277741|Dietary Supplement|RS4 bar|The RS4 group will consume one nutrition bar per day formulated using Fibersym® RW containing 20g fiber.
15820848|NCT04277663|Drug|IBI310+IBI308|In this group, subjects will be given IBI310 3mg/kg IV Q3W in combination with IBI308 200mg IV Q3W for 4 cycles, then follow up a maintenance therapy performed with IBI310 3mg/kg IV Q12W in combination with IBI308 200mg IV Q3W until disease progression or loss of clinical benefit.
15820849|NCT04277663|Drug|IBI308|In this group, subjects will be given IBI308 200mg IV Q3W until disease progression or loss of clinical benefit
15820850|NCT04277663|Drug|High-dose recombinant interferon a-2B|In this group, subjects will be given 15*10^9 U/m2/d recombinant interferon a-2B intravenously on days 1-5 weekly for 4 weeks.Then 9*10^9 U/m2/d recombinant interferon a-2B intravenously three times weekly for 48 weeks
15820851|NCT04277650|Other|Machine learning algorithm|machine learning directed identification of radiotherapy or chemoradiotherapy patients at high-risk for emergency department acute care and/or hospitalization
15820852|NCT04277637|Drug|BGB-11417|Film-coated tablets administered once daily at a dose as specified in the treatment arm
15820853|NCT04277637|Drug|Zanubrutinib|320 mg administered as twice-daily zanubrutinib should be administered as two 80-mg capsules twice a day (160 mg twice a day) or oOnce-daily zanubrutinib should be administered as four 80-mg capsules once a day (320 mg once a day)
15820854|NCT04277624|Drug|fezolinetant - test formulation|Administered orally
15820855|NCT04277624|Drug|fezolinetant - reference formulation|Administered orally
15820856|NCT04277611|Procedure|Subcostal Oblique Quadratus Lumborum Block and Erector Spinae Plain Block.|patients undergo general anesthesia,will be put in prone position.In case of Quadratus Lumborum block 1-3 mL of normal saline is injected to produce hydro-dissection and spread cranially between the QL and kidney. The corresponding ultrasonographic sign is a lunar-shaped hypo-echoic fluid collection observed between the long axis of the kidney and QL muscle. 20 ml Bupivacaine 0.5%, 10 ml Lidocaine 2%, and 10 ml normal saline is administered. In case of the ESPB The location of the needle tip is confirmed by hydro-dissection and after visualizing the fluid spread lifting the Erector Spinae off the transverse process, 20 ml bupivacaine 0.5%, 10 ml Lidocaine 2%, and 10 ml normal saline is injected.
15820857|NCT04277598|Biological|APO-2|APO-2: dose adjusted gel for topical administration.
15820858|NCT04277598|Other|Placebo|Placebo gel for topical administration.
15820859|NCT04277585|Other|Telehealth|Early Psychosis Coordinated Specialty Care Services via telehealth.
15820860|NCT04277572|Procedure|Aortic valve replacement|Aortic valve surgery
15820861|NCT04277559|Other|Patient preferential music|Patients will listen to their preferred music through the headphones before surgery.
15820862|NCT04277559|Other|Classical music|Patients will listen to classical music through headphones before surgery.
15820863|NCT04277559|Other|No music|Patients will not listen to music.
15820864|NCT04277546|Drug|Brazikumab Maintenance Dose|Completers in the lead-in study D5272C00001 (Legacy #3151-201-008) will receive a maintenance dose of brazikumab administered subcutaneously every 4 weeks up to Week 52 (Group A). The SC dose of brazikumab will be administered to all responders/completers in the lead-in study regardless of the prior treatment administered.
15820865|NCT04277546|Drug|Brazikumab Induction Dose|Participants in the lead-in study D5272C00001 (Legacy #3151-201-008) who have not responded to treatment and have met criteria for rescue treatment are considered inadequate/non-responders (Group B). In these eligible participants, IV induction dosing of brazikumab at Week 0, Week 4, and Week 8 will be administered, followed by brazikumab administered subcutaneously every 4 weeks thereafter (up to Week 52).
15820866|NCT04277533|Diagnostic Test|Serum γ-Glutamyl transferase (GGT), Total serum bilirubin (TSB), Serum calcium concentration (Ca2+), Peripheral blood neutrophil to lymphocyte ratio (NLR)|GGT, Ca2+, NLR and TSB are serum markers which had been studied for early detection and prediction of severity of NEC.
15820867|NCT04277520|Procedure|Root canal therapy|Different types of instrumentation motions during root canal therapy
15820868|NCT04277507|Device|Vivaer Stylus|Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area
15820869|NCT04277494|Other|Clorethyl cold spray® (Vapocoolant spray)|From the anterior superior of the dominant legs to the spinal iliac, the upper part of the patella will be measured and the center point will be marked. Cold spray will be applied to this point and its surroundings. The ethyl chloride spray bottle will be kept approximately 30 cm from the skin. An ethyl chloride stream will be applied at a 45 ° angle for 15 seconds (Shadgan et al., 2015). Skin temperature and mechanical properties of muscle; will be measured before, immediately after, 2 minutes, 5 minutes and 15 minutes after cold application.
15820870|NCT04277481|Other|10 minute cold pack|10 min package (35 * 29 cm) will be wrapped with a towel and applied to the rectus femoris part of the quadriceps.
15820871|NCT04277481|Other|12 minute cold pack|12 min package (35 * 29 cm) will be wrapped with a towel and applied to the rectus femoris part of the quadriceps.
15820872|NCT04277481|Other|15 minute cold pack|15, min package (35 * 29 cm) will be wrapped with a towel and applied to the rectus femoris part of the quadriceps.
15820873|NCT04277481|Other|20 minute cold pack|20 min package (35 * 29 cm) will be wrapped with a towel and applied to the rectus femoris part of the quadriceps.
15820874|NCT04277442|Drug|Decitabine|Given IV
15820875|NCT04277442|Biological|Nivolumab|Given IV
15820876|NCT04277442|Drug|Venetoclax|Given PO
15820877|NCT04277429|Diagnostic Test|Cardiac function assessment|Echocardiography, cardiac enzymes analysis
15820878|NCT04277416|Device|Total Hip Arthroplasty|To evaluate Implant survival based on removal or intended removal of any component of the Entrada™ Hip System at five years of follow-up.
15820879|NCT04277403|Radiation|Hippocampal Avoiding Whole Brain Radiation Therapy with Simultaneous Integrated Boost|Hippocampal avoiding Whole brain radiation therapy (HA-WBRT) with volumetric modulated arc therapy (VMAT) with a prescribed dose of 30Gy in 12 fractions, 2.5Gy per fraction and a simultaneously integrated boost (SIB) to each brain metastasis of 51Gy to 95% of PTV in 12 Fractions, 4.25Gy per fraction.
15820880|NCT04277403|Radiation|Single session or hypofractionated stereotactic radiosurgery|Single session or hypofractionated stereotactic radiosurgery (SRS) of multiple brain metastases. Single session SRS will be delivered in 18 to 22Gy to the tumour encompassing 80% Isodose. Hypofractionated stereotactic radiosurgery (HfSRS) will be delivered in 5 sessions of 6Gy each to the tumour encompassing 80% isodose.
15821146|NCT04275232|Biological|Allogenic plasma aliquots, a source of plasminogen|Plasma eye drops, a source of plasminogen
15821147|NCT04275219|Drug|Tongfu capsules|Tongfu capsules include 5 herbals
15820881|NCT04277390|Other|clinical intervention for microbial analysis and MIR155 as biomarker|Subgingival plaque was collected with sterile curette and placental tissue sample(postpartum with surgical blade with the help of gynecologist. all the samples were subjected to RTPCR for analysis of microorganisms likeTannerella forsythia(Tf), Treponema denticola(Td), Porphyromonas gingivalis(Pg), Prevotella intermedia(Pi), Fusobacterium nucleatum(Fn). Herpes Simplex Virus(HSV), Ebstein Barr Virus(EBV), Human Cytomegalovirus(HCMV). and MIR155 levels were also estimated
15820882|NCT04277364|Dietary Supplement|phosphatidic acid supplementation|The total daily doses will be distributed in 3 individual doses: in the group that will ingest 750mg per day, the individual doses will be 250mg, while in the group that will ingest 375mg per day, the individual doses will be 125mg. The capsules should be consumed at breakfast, 30 minutes before each training session (or at lunch, on days when there is no training) and at dinner.
15820883|NCT04277364|Other|Placebo (corn starch supplementation)|Three individual doses of corn starch will be consumed per day. The capsules should be consumed at breakfast, 30 minutes before each training session (or at lunch, on days when there is no training) and at dinner.
15820884|NCT04277364|Other|Strength training|All participants will be submitted to a 8-week strength training program, with 3 training sessions per week, totaling 24 training sessions.
15820885|NCT04277351|Device|Transcranial alternating current stimulation|Focal transcranial stimulation over auditory cortex by means of 5 electrodes delivering an electric current (max. 2mA). In addition to active stimulation, also a placebo (sham) stimulation is employed as a control condition. All subjects included in the study receive all tACS stimulation conditions.
15820886|NCT04277338|Drug|SPECT|One single injection of 99mTc-HE3-G3, followed by gamma camera imaging directly postinjection and after 2, 4, 6 and 24 hours.
15820887|NCT04277325|Behavioral|Emotionally Focused Therapy|Emotionally Focused Couples Therapy (EFT) is an empirically supported, attachment-based model of couples therapy that combines experiential, systems, and attachment theories with the goal of fostering the development of safe contact, accessibility, and responsiveness in both partners.
15820888|NCT04277312|Behavioral|Engage|The Engage intervention was developed with input from primary school teachers and includes a range of age-appropriate educational activities related to food. Activities include videos, lesson plans, worksheets, games, talks/visits from experts, visits to industrial partners and other local food-related centres of interest and practical activities such as experiments. All 'Engage' material is mapped to the Northern Ireland School Curriculum. The 'Engage' intervention is structured into three broad topics: Farm to Fork; Pleasure on a Plate and Food Futures. Engage resources were provided to schools electronically and in hard copy and teachers delivered most of the content, with the exception of several sessions which were delivered by visiting scientists.
15820889|NCT04277312|Behavioral|Nourish|The Nourish intervention is a school food environment intervention which included weekly healthy snack provision supplied by food industry partners, enhancement of canteen dining area (café style, tablecloths, centre pieces, bunting and menu boards, healthy eating posters), attendance at Tasting Days held in Higher Education Colleges (children were encouraged to try new foods provided by industry partners and received stamps on 'food passports' in return) and sensory educational and cookery activities.
15820890|NCT04277299|Device|IcorySolution|The ICory-solution programme is designed to be a self-guided and healthcare professional-led. Participants will have access to BuddyCare for parents and Triumf Health from time of recruitment till 2 weeks after surgery. The healthcare professional have received face-to-face training on how to use the BuddyCare dashboard and BuddyCare has been in the hospital in earlier studies.The Buddy Healthcare mobile app (BuddyCare) that provides a comprehensive day-by-day perioperative guide for parents regarding their child's surgery with an interface for health care professionals to monitor parents' and their children's needs as well as communicate with them. (2) The Triumf Health mobile game app that provides emotional support, games and distraction to children and a virtual tour to the hospital before children´s operation.
15820891|NCT04277286|Behavioral|survey|"Behavioral study of patients who are in the Transend Program (compliance in follow-up visits after transfert from pediatric to adult care in the 24 months)"
15820892|NCT04277273|Other|Questionnaire|Questionnaires WHOQOL-BREF and GOHAI
15820893|NCT04277247|Drug|Botulinum toxin type A|A standardized dose will be injected in each muscle: 25 Units of BTXA in the extensor hallucis longus in 1 site, 50 Units of BTXA in the flexor digitorum brevis in 2 sites and 25 Units of BTXA in the tibialis posterior in 1 site.
15820894|NCT04277247|Drug|Placebo|0.9% saline placebo injection
15820895|NCT04277221|Biological|Autologous Dendritic Cell/Tumor Antigen, ADCTA|ADCTA is an individualized cell immunotherapy co-culturing autologous dendritic cells derived from peripheral blood mononuclear cells (PBMNCs) with autologous tumor cell as antigen in order to evoke specific immune response.
15820896|NCT04277195|Diagnostic Test|SPAG5 Assay|Testing for SPAG5 expression in the tumour.
15820897|NCT04277182|Biological|burn wound dressing|"st. group: It will be considered as a control group and rats will not be treated.
~nd. group: Vehicle group, Propolis vehicle will be applied topically to rats for 21 days.
~rd group: Silver Sulfadiazine group, 1% Silver Sulfadiazine will be applied topically to rats for 21 days.
~th. group: Nitrafurozon group, 0.2% Nitrafurozon will be applied topically for 21 days.
~th. group: 10% Propolis group, 10% Propolis will be applied topically for 21 days.
~th. group: 15% Propolis group, 15% Propolis will be applied topically for 21 days."
15820898|NCT04277156|Dietary Supplement|Lactobacillus rhamnosus ATCC 53103 & Lactobacillus reuteri DSM 29063|7 drops contain Lactobacillus rhamnosus GG 5x10^9 CFU; and Lactobacillus reuteri 1x10^8 CFU.
15820899|NCT04277156|Dietary Supplement|L rhamnosus ATCC 53103|5 drops contain Lactobacillus rhamnosus 5x10^9 CFU.
15820900|NCT04277143|Drug|Daptomycin|"Adult patients are given the recommended dose of daptomycin for injection. Patients with creatinine clearance (CLCR) ≥ 30 mL / min: 6 mg / kg every 24 hours.
~Patients with creatinine clearance (CLCR) <30mL / min (including hemodialysis or peritoneal dialysis): 6mg / kg every 48 hours. Dissolve 6mg / kg of this drug in 0.9% sodium chloride injection and instill it over a 30-minute time course once every 24 or 48 hours."
15820929|NCT04276896|Biological|Injection and infusion of LV-SMENP-DC vaccine and antigen-specific CTLs|Patients will receive approximately 5x10^6 LV-DC vaccine and 1x10^8 CTLs via sub-cutaneous injections and iv infusions, respectively.
15820930|NCT04276883|Drug|Sublingual film containing Dexmedetomidine (BXCL501)|Sublingual film containing Dexmedetomidine (BXCL501)
15820931|NCT04276883|Drug|Placebo Film|Placebo Film for BXCL501
15820901|NCT04277130|Behavioral|Intervention with active video games|Participants in intervention group were paired up by their teachers. Each participant had a classmate playing with him/her, and the waiting time is minimal because Xbox 360 Kinect allowed double play mode. The intervention group was provided with an AVG, the Xbox 360 Kinect technology (Kinect Sports Seasons I & II, including bowling, soccer, boxing, track and field, table tennis, beach volleyball, golf, tennis). The AVG intervention consisted of two 30-min sessions per week, for a total of 12 weeks. Participants either played in PE classes and/or recess. They had no other specific routing of activities but straight played the AVG during the intervention. They could free to choose games they like in the Xbox 360. The AVGs of Xbox 360 chosen was of moderate to vigorous intensity (3-6 METs) and no matter what games they chose, their PA level would be between moderate and vigorous intensity.
15820902|NCT04277117|Dietary Supplement|Medically tailored meals|6 months of medically tailored meals delivered Monday- Friday by a Meals on Wheels volunteer or driver.
15820903|NCT04277117|Other|No medically tailored meal|Remain on wait list
15820904|NCT04277104|Other|Closed loop acoustic stimulation|The intervention consists of three consecutive nights of closed loop acoustic stimulation during slow wave sleep. An established closed-loop algorithm is utilized that detects slow oscillations in the electroencephalogram and is programmed to present short tones (50 ms) into their up-states. Tones will be presented via a headband with integrated speakers. The procedure does not wake participants
15820905|NCT04277104|Other|Sham acoustic stimulation|Sham acoustic stimulation: participants wear the headband but no stimuli are delivered during slow wave sleep. This ensures that in both the control and the intervention group the conscious experiences are the same.
15820906|NCT04277091|Other|High-intensity interval training|Arm-cranking exercise
15820907|NCT04277091|Other|Moderate-intensity continuos training|Arm-cranking exercise
15820908|NCT04277065|Procedure|BULLDOG ,A Useful Vascular Occlusion Tourniquet In Laparoscopic Liver Resection|Bulldog is an effectively performed approach for vascular occlusion during laparoscopic hepatectomy than traditional Pringle manuever.
15820909|NCT04277065|Procedure|cotton tourniquet|cotton tourniquet
15820910|NCT04277052|Device|Determination muscles sections by Ultrasonography|Determination muscles sections by Ultrasonography
15820911|NCT04277039|Other|osteopathic treatment + cognitive training|This intervention is a combination of manipulative osteopathic treatment and cognitive training to be administered each week for a 12-week study period
15820912|NCT04277039|Other|osteopathic treatment|manual treatment using osteopathic procedure. 8 sessions for a 12 week study period
15820913|NCT04277039|Other|usual care|administration of non-steroid inflammatory drug according to international guidelines
15820914|NCT04277026|Behavioral|Mindful Walking|Eight weekly 60 minute mindful walking sessions involving observations of bodily sensations, experiences, and breath. Discussion of mindful walking experiences and encouragement to meet physical activity goals.
15820915|NCT04276987|Biological|MSCs-derived exosomes|5 times aerosol inhalation of MSCs-derived exosomes (2.0*10E8 nano vesicles/3 ml at Day 1, Day 2, Day 3, Day 4, Day 5).
15820916|NCT04276974|Other|Organic diet|Organic plant-rich foods (2000kcal for women, 2500kcal for men)
15820917|NCT04276974|Other|Non-organic diet|Likewise Non-organic plant-rich foods (2000kcal for women, 2500kcal for men)
15820918|NCT04276961|Other|Acupuncture|Acupuncture will be given for a total of 12 session over 4 weeks. Acupuncture at acupoints Tianshu (ST25), Shangjuxu (ST37), Zusanli (ST36), and Neiguan (PC6) bilaterally will be given.
15820919|NCT04276948|Dietary Supplement|NAD3|NAD3 is an over-the-counter dietary supplement available online to consumers.
15820920|NCT04276935|Other|Interview|Participate in cognitive interview
15820921|NCT04276935|Other|Quality-of-Life Assessment|Ancillary studies
15820922|NCT04276935|Other|Questionnaire Administration|Ancillary studies
15820923|NCT04276922|Behavioral|Visual Arts|"Subjects meet for 90 minutes, once weekly, over 12 weeks for guided drawing/sketching sessions. The 12 sessions will follow a standard sequence that addresses three primary themes: creating safety, inviting vulnerability, and integrating into a transformative community.
~Surveys, activity diary cards will be completed at baseline, weekly and at intervention completion to assess satisfaction, stress, and well-being. Qualitative focus groups will occur after the intervention to assess acceptability of intervention, outcomes assessments, program development and implementation."
15820924|NCT04276922|Behavioral|Music|"Subjects meet for 90 minutes, once weekly, over 12 weeks, for guided music-listening exercises (such as lyric analysis, patient-chosen, music for relaxation and/or visualization) and active music making. The 12 sessions follow a standard sequence, addressing three primary themes: creating safety, inviting vulnerability, and integrating into a transformative community.
~Surveys, activity diary cards are completed at baseline, weekly and at completion to assess satisfaction, stress, and well-being. Qualitative focus groups, after the intervention, assess acceptability of intervention, outcomes, program development and implementation."
15820925|NCT04276922|Behavioral|Dance/Movement|"Subjects will meet once weekly, and begin with a movement check-in, a gentle physical warm-up, and then either a structured or improvisational movement process. for a total of 12 weeks. Each session will last 90 minutes. The 12 sessions will follow a standard sequence that addresses three primary themes: creating safety, inviting vulnerability, and integrating into a transformative community.
~Surveys, activity diary cards will be completed at baseline, weekly and at intervention completion to assess satisfaction, stress, and well-being. Qualitative focus groups will occur after the intervention to assess acceptability of intervention, outcomes assessments, program development and implementation."
15820926|NCT04276922|Behavioral|Writing/Poetry|"Subjects will meet once weekly, for writing workshops to encourage participants to tell the stories they need to tell, using integral elements of good writing, for a total of 12 weeks. Each session will last 90 minutes. The 12 sessions will follow a standard sequence that addresses three primary themes: creating safety, inviting vulnerability, and integrating into a transformative community.
~Surveys, activity diary cards will be completed at baseline, weekly and at intervention completion to assess satisfaction, stress, and well-being. Qualitative focus groups will occur after the intervention to assess acceptability of intervention, outcomes assessments, program development and implementation."
15820927|NCT04276922|Behavioral|Control|Control Group will only complete surveys at baseline and 12 weeks later.
15820928|NCT04276909|Combination Product|LUM Imaging System|LUM015 will be administered at the beginning of surgery. All subjects will have intraoperative imaging using the LUM imaging device.
15820932|NCT04276870|Biological|Murine CART19|CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv:41-BB:TCRζ, administered by IV injection with a planned dose of 5x106 CART19 cells/kg on day 0 with possible reinfusion/retreatment
15820933|NCT04276857|Device|Irreversible electroporation (NanoKnife® )|IRE is a unique treatment modality as it ablates tumor cells without using heat or radiation and hence does not cause injury to nearby blood vessels, ducts, and bowel. This makes it particularly appealing for the treatment of locally advanced unresectable pancreatic cancers. This local treatment for cancer involves delivering brief pulses of high voltage electrical current across the tumor (either percutaneously or open surgery), which results in the formation of tiny holes (nanopores) in the cell membranes.
15820934|NCT04276844|Diagnostic Test|Ultrasonography using the two-dimensional (2D) mode|Diaphragmatic amplitude assessed by ultrasonography during quiet breathing and after sniff test, before the surgery and at day 7 post-surgery in all patients.
15820935|NCT04276844|Diagnostic Test|Respiratory Functional Explorations|Forced vital capacity (FVC), forced expiratory volume in 1 second (FEV) and total lung capacity (TLC) measured at day 7
15820936|NCT04276831|Device|Laryngoscope McCoy|Subjects who fulfill inclusion criteria will be intubated using laryngoscope McCoy
15820937|NCT04276831|Device|Laryngoscope Macintosh|Subjects who fulfill inclusion criteria will be intubated using laryngoscope Macintosh
15820938|NCT04276818|Procedure|PRP group|Demonstrating the effectiveness of dressing with PRP in the treatment of second-degree burns
15820939|NCT04276818|Procedure|conventional treatment group|The effectiveness of conventional dressing containing silver sulfadiazine in the treatment of burns will be compared with the method of dressing with PRP.
15820940|NCT04276805|Device|Transcutaneous vagal nerve stimulation (tVNS)|a non-invasive and safe technique that transiently enhances brain GABA and noradrenaline levels.
15820941|NCT04276805|Behavioral|cognitive training|A program of regular mental activities purported to maintain or improve one's cognitive abilities.
15820942|NCT04276792|Behavioral|TCU Opioid-Treatment Linkage Model (O-TLM)|The O-TLM is focused on best practices for improving screening, identifying and linking to MOUD providers, reducing stigma, and addressing other important factors that impact justice-involved individuals returning to their communities.
15820943|NCT04276779|Drug|Alcohol administration|Participants in the alcoholic beverage group will be provided a dose of 95% alcohol (0.99g/kg for males and 0.90 g/kg for females body weight) distributed in two equally spaced beverages (mixed with orange juice 1:5 ratio). This dose will produce a breath alcohol content ranging between .08-.10.
15820944|NCT04276779|Other|Placebo administration|Individuals in the placebo condition will receive orange juice with 4 ml of alcohol layered on top of the juice. Ethanol will be sprayed on the rims of the glasses.
15820945|NCT04276779|Behavioral|Positive mood induction|Participants will be randomized to either positive mood induction procedure. Both conditions involve listening to music that reliably induces positive mood, while simultaneously reading self-referent statements that also induce either positive mood. This procedure lasts about 10 minutes and produces a transient mood state that passes by the end of the study.
15820946|NCT04276779|Behavioral|Negative mood induction|Participants will be randomized to either negative mood induction procedure. Both conditions involve listening to music that reliably induces sad mood, while simultaneously reading self-referent statements that also induce either sad mood. This procedure lasts about 10 minutes and produces a transient mood state that passes by the end of the study.
15820947|NCT04276766|Other|Crossover intervention|"Drink consumption was followed by regular BP measurements and collection of saliva samples every 30 minutes for four hours. Microcirculatory measurements were then repeated and saliva and urine samples were collected again.
~After the last measurement subjects were provided with a standardized meal with a very low nitrate intake to eat within 30minutes. Participant then left the research centre and they were asked to collect a saliva sample after two hours from the completion of the meal. This was immediately followed a dose of labelled nitrate (4mg in 100ml of distilled water) to drink within one minute. Subjects were then asked to collect six additional saliva samples until the next morning (four before going to bed and two in the morning), accompanied by measurements of resting BP.
~Cross-over assessments were then repeated in the same order at Visit 3, followed a wash-out period of at least one week before entering the second arm of the study."
15820948|NCT04276753|Other|Terminalia Chebula Fruit Extract|Standardized fruit extract
15820949|NCT04276753|Other|Placebo|Placebo
15820950|NCT04276740|Dietary Supplement|MitoQ|"MitoQ in inflammation: In the experimental setting, MitoQ has been extensively studied with clear mode of action on inflammatory mechanisms relevant to IBD:
~MitoQ can limit the damage to mitochondria caused by mitochondrial ROS and thereby reducing the leak and oxidisation of mtDNA that are critical to its pro-inflammatory actions within the cell.
~MitoQ reduces the inflammatory potential of mitochondrial DNA which have escaped or released from dying inflammatory cells.
~MitoQ can influence how the immune cells generate their energy, diverting it away from a more inflammatory type of metabolism (glycolysis)
~MitoQ can induce autophagy, a cellular recycling mechanism that removes damaged mitochondria. Defective autophagy is heavily implicated in the pathogenesis of IBD.
~Hence collectively, MitoQ acts upstream of several pro-inflammatory mechanisms with the net effect to promote resolution of inflammation and mucosal healing."
15820951|NCT04276740|Other|Placebo|Placebo
15820952|NCT04276727|Drug|MINT study IMP|Application of gel for 6 weeks.
15820953|NCT04276714|Other|Socket without Revofit system|All the tests are evaluate during one week with the classical type of fittings
15820954|NCT04276714|Other|Socket with Revofit system|All the tests are evaluate during one week with the adjustable type of fittings (that is to say with Revofit system)
15820955|NCT04276701|Biological|blood sample|35 ml whole blood for Peripheral blood mononuclear cell (PBMC), serum and plasma
15820956|NCT04276701|Other|Ultrasonography assessment|assessment of atherosclerotic plaques and measurement of carotid intima-media thickness (cIMT)
15820957|NCT04276701|Behavioral|questionnaires|Food and exercise questionnaires validated by the American heart Association
15820958|NCT04276688|Drug|Lopinavir/ritonavir|400mg/100mg twice daily for 14 days
15820959|NCT04276688|Drug|Ribavirin|400mg twice daily for 14 days
15820960|NCT04276688|Drug|Interferon Beta-1B|0.25mg subcutaneous injection alternate day for 3 days
15820961|NCT04276662|Drug|DS-3201b|1 dose of 50 mg DS-3201b
15821032|NCT04276116|Behavioral|Pulmonary age|Communication of pulmonary age
15820962|NCT04276649|Drug|Caltrate|Patients in supplementary group were received with Caltrate 0.6 g/d and Mesalazine 4g/d orally at least 12 months, and those in non-supplementary only take Mesalazine 4g/d.
15820963|NCT04276636|Drug|Caltrate Pill|Vitamin D-deficient CD patients are divided into two groups, one group is given orally with Caltrate Pill 0.6 g / d, while the other group do not interfere.
15820964|NCT04276610|Behavioral|Low Vision Reading Rehabilitation|Following Time 1, participants will receive the full complement of vision rehabilitation services available and deemed suitable by their clinical staff and rehabilitation professionals of either rehabilitation centre, according to the provision of assistive devices and services regulated by the Quebec Health Insurance (RAMQ). These services are include but are not limited to: a full optometric exam to determine functional vision, including refraction and the prescription of appropriate near and distance glasses and optical devices, an assessment by a low vision therapist and/or occupational therapist, the loan provision of hand-held optical magnification devices, electronic non-optical magnification devices (e.g., portable or table-top closed-circuit televisions), or computer software for screen content magnification (e.g., ZoomText), with appropriate training and follow-up sessions in the home, if required.
15820965|NCT04276597|Drug|177Lu-DOTATOC|177Lu labeled somatostatin receptors targeting ligand
15820966|NCT04276584|Device|Positive airway pressure (PEP)|3 blocks of 10 deep inspiration followed by expiration against a positive airway pressure device of 10-15 cm H2O. Repeated three times. Estimated time of 3 minutes time.
15820967|NCT04276584|Other|Speaking loudly during about 3 minutes|A specified swedish text
15820968|NCT04276584|Other|Singing|Singing a Swedish song
15820969|NCT04276571|Device|exergames with GRAIL virtual immersive reality environment|The participants will perform exergames on GRAIL immersive virtual reality to improve balance (e.g. load shifts, exercises with adaptations to motor perturbations). GRAIL can provide proprioceptive and visual feedback to participants.
15820972|NCT04276545|Drug|IV administration of DEX to investigate the effects for functional nasal endoscopic surgery|IV administration of a single loading dose DEX (0.5μg/kg) after induction within 10 minutes.
15820973|NCT04276545|Drug|IV administration of Midazolam to investigate the effects for functional nasal endoscopic surgery|IV administration of midazolam (0.05mg/kg) after induction.
15820974|NCT04276532|Procedure|sentinel lymph node sampling (SLN)|"Total hysterectomy with/without bilateral salpingooophorectomy (THBO) plus sentinel lymph node sampling (SLN).
~The principles of surgery procedures and post-operative adjuvant therapies will follow the latest NCCN guidelines；
~Surgery carried out by laparotomy, laparoscope, or robotic surgery are accepted；
~Colored dyes including indocyanine green (ICG) (preferred), methylene blue, carbon nanotube for sentinel lymph node are accepted."
15820975|NCT04276532|Procedure|pelvic lymphonodectomy (PLN)|Total hysterectomy with/without bilateral salpingooophorectomy (THBO) plus pelvic lymphonodectomy (PLN) with para-aortic sampling
15820976|NCT04276519|Procedure|Physiotherapeutic, non-invasive position-induced opening of the intervertebral foramen|Opening of the mechanical interface of the nerve root, neurodynamics
15820977|NCT04276506|Other|music group|to reduce anxiety, some selected music pieces will have patients listened by headset.
15820978|NCT04276506|Other|information group|A visual information booklet which is prepared by the researchers will be used
15820979|NCT04276493|Biological|ZW25|Administered as specified in the treatment arm
15820980|NCT04276493|Drug|Docetaxel|Administered as specified in the treatment arm
15820981|NCT04276493|Biological|Tislelizumab|Administered as specified in the treatment arm
15820982|NCT04276493|Drug|Capecitabine|Administered as specified in the treatment arm
15820983|NCT04276493|Drug|Oxaliplatin|Administered as specified in the treatment arm
15820984|NCT04276480|Drug|Piperacillin-tazobactam|"At the time of ventilator-associated pneumonia diagnosis, patients will receive an initial 4g loading dose of piperacillin-tazobactam with a continuous maintenance dose of 16g per day the first day of treatment. The dose of the piperacillin-tazobactam administered the following days will be adjusted to the renal function.
~The antimicrobial treatment will be adjusted to the narrower-spectrum agent after the antimicrobial susceptibility determination for a total length of treatment of seven days."
15820985|NCT04276454|Device|Flexitouch Plus system|A single treatment for external lymphedema using the FDA-approved Flexitouch Plus device.
15820988|NCT04276428|Drug|LY3209590|Administered SC.
15820989|NCT04276428|Drug|Insulin Degludec|Administered SC.
15820991|NCT04276402|Procedure|Irradiation of implants with 808nm laser|Irradiation of implants with 808nm laser
15820992|NCT04276389|Device|OCT-guided paclitaxel drug-coated balloon angioplasty|OCT-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery
15820993|NCT04276389|Device|Angiography-guided paclitaxel drug-coated balloon angioplasty|Angiography-guided paclitaxel drug-coated balloon angioplasty in middle-sized de novo coronary artery
15820994|NCT04276376|Drug|Atezolizumab|Fc-engineered, humanized, Ig G1 monoclonal antibody against PDL-1 1200mg q3w
15820995|NCT04276376|Drug|Rucaparib|Inhibitor of poly-adenosine diphosphate [ADP] ribose polymerase (PARP) 600mg BID
15820996|NCT04276363|Behavioral|Thrive Professional Learning plus ParentCorps|led by the NYC Department of Education. Professional Learning sessions are tailored to the needs of pre-K teachers and leaders, and include topics aligned with the district's quality standards that support child instructional goals.
15821148|NCT04275219|Drug|The Placebo of Tongfu capsules|The Placebo of Tongfu capsules are made from dextrin, starch and so on.
15820997|NCT04276363|Behavioral|Thrive Professional Learning only|Part of the Professional Learning Track system for all Pre-K for All teachers and leaders. The NYC DOE schedules Thrive Professional Learning training days for staff on non-attendance days. Teachers attend four Professional Learning days annually, and leaders attend three days annually, over a two-year period.
15820998|NCT04276363|Behavioral|Inspire Professional Learning|Delivered to leaders in groups of 20 - 40 three times a year over the same two-year period. Content covers best practices in Family Engagement and Social Emotional Learning and includes an experiential approach to behavior change that asks learners to take the perspective of others and consider their own beliefs and assumptions about students, families, teachers and leaders
15820999|NCT04276350|Procedure|Acupuncture|Acupuncture sessions - 2-3 times/week, each session lasting 1 hour, over a period of 10 weeks (with allowed deviation up to 2 weeks due to scheduling)
15821000|NCT04276350|Procedure|Best Medical Therapy|Best Medical Therapy - 3 biofeedback sessions over a period of 10 weeks (with allowed deviation up to 2 weeks due to scheduling), where subjects learn and practice the exercises daily
15821001|NCT04276337|Diagnostic Test|LiquidSCAN(Trade Mark) / CancerSCAN(Trade Mark)|LiquidSCAN : detection of circulating DNA CancerSCAN : detection of somatic mutation using tumor tissue
15821002|NCT04276324|Other|Resistance training|Ten weeks of resistance training
15821003|NCT04276324|Other|Testing sessions|Testing sessions
15821004|NCT04276311|Device|Percutaneous transluminal angioplasty|The purpose of this study is to evaluate the efficacy and the feasibility of atherectomy, using the Jetstream™ artery preparation associated to DCB treatment (Ranger™ Paclitaxel-Coated balloon), in symptomatic patients with claudication (Rutherford 2 and 3) and with complex de novo femoropopliteal arterial lesions (TASC C).
15821005|NCT04276298|Drug|Metronidazole cream|10% metronidazole applied rectally
15821006|NCT04276298|Drug|Metronidazole and Diltiazem cream|Combination Metronidazole and Diltiazem applied rectally
15821007|NCT04276298|Drug|Metronidazole and Lidocaine cream|Combination metronidazole and lignocaine applied rectally
15821008|NCT04276298|Drug|Metronidazole, Diltiazem and Lidocaine cream|Combination of all active agents tested applied rectally
15821009|NCT04276285|Procedure|Laparoscopic TAP|Subcostal TAP block will be performed after surgery under laparoscopic guidance
15821010|NCT04276285|Procedure|US TAP|Subcostal TAP block will be performed after surgery under US guidance
15821011|NCT04276272|Other|Imaging scan|PET/CT scan
15821012|NCT04276259|Drug|Buprenorphine|Buprenorphine is a μ-opioid partial agonist and kappa-opioid antagonist that is used to treat moderate to severe pain and opioid dependence. The intramuscular administered opioid agonist which will be used to modulate reward learning signals to understand placebo effects in patients with depression. In the buprenorphine condition, participants will receive one IM injection of 0.3mg/1ML buprenorphine hydrochloride (Buprenex®. Richmond, VA: Reckitt Benckiser Pharmaceuticals Inc.; 2006) (onset of action: ≥15 minutes; peak effect: ~1 hour; duration: ~6 hours) and an oral placebo tablet.
15821013|NCT04276259|Drug|Naltrexone|Naltrexone is thought to strongly block μ-opioid receptors. Oral (pill) opioid antagonist which will be used to modulate reward learning signals to understand placebo effects in participants with depression. In the naltrexone condition, participants will receive one tablet of 50mg Naltrexone hydrochloride (ReVia®. Toronto, ON: Teva Canada Limited; 2015) (onset of action: ≥15 minutes; peak effect: ~1 hour; duration: ~24 hours) and a saline IM injection.
15821014|NCT04276259|Drug|Oral Placebo|Oral placebo: to match the oral naltrexone.
15821015|NCT04276259|Drug|IM Placebo|IM saline placebo: to match the i.v. buprenorphine.
15821016|NCT04276259|Device|Theta burst stimulation (TBS) of the ventromedial prefrontal cortex.|Participants will receive two blocks of each TBS form. During the first block, stimulation intensity will be gradually escalated in 5% increments (from 80% to 110% rMT) in order to enhance tolerability. In all conditions, the investigators will apply 600 pulses of theta burst at 110% RMT. Each block of iTBS will consist of 20 trains, each lasting 2s with intertrain intervals of 8s, for a total of 192s. Each block of cTBS will consist of one continuous train of 40s. The sTBS will make use of two surface electrodes placed on the scalp.
15821017|NCT04276246|Device|dental implants and retentive implant components|retentive components (Group A Test), which are connected to the implants to retain the RPD
15821018|NCT04276246|Device|dental implants and supportive implant components|supportive components (Group B Control), which are connected to the implants to support the RPD
15821022|NCT04276220|Diagnostic Test|Tenosynovial biopsy|Tenosynovial biopsy taken from the wrist at the carpal tunnel release surgery.
15821023|NCT04276207|Drug|LY900014|Administered by CSII
15821024|NCT04276207|Drug|Insulin Lispro|Administered by CSII
15821025|NCT04276194|Procedure|Intensity-Modulated Proton Therapy|Undergo intensity modulated proton therapy
15821026|NCT04276194|Procedure|Magnetic Resonance Imaging|Undergo MRI
15821027|NCT04276155|Drug|non-systematic prescription of anticoagulant therapy|the prescription of anticoagulant is managed by an implantable device follow up
15821028|NCT04276142|Behavioral|ceprica (additional to care as usual)|ceprica is a dialogue-based online psychological intervention for patients with headache (tension-type or migraine). This intervention includes elements that address pain management, pain reduction etc. Content is adapted to users needs using interactive dialogues, illustrations and audio files. Participants may also continue with their usual care.
15821029|NCT04276142|Behavioral|ceprica control (additional to care as usual)|placebo-like online evidence-based information regarding headache. Additionally, participants may continue with any treatment that they require (care as usual)
15821030|NCT04276129|Procedure|periodontal surgery + 24 hr buccal attached gingiva (G) biopsy|Periodontal surgery will be performed and 24 hr after the surgical procedure a 2mm punch biopsy will be harvested at the level of the buccal attache gingiva (G).
15821031|NCT04276129|Other|post-surgical CHX mouth-rinses indication|CHX mouth-rinses (0.12%) will be indicated 2 times/day after the surgical procedure
15821033|NCT04276090|Device|Hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.|Patients will undergo surgical hepatic artery infusion pump placement using the Synchromed II pump and the Codman tapered arterial catheter.
15821034|NCT04276090|Drug|Hepatic artery infusion pump floxuridine and dexamethasone|Patients will receive infusion of floxuridine (FUDR) and dexamethasone via hepatic artery infusion through the implanted pump
15821035|NCT04276090|Drug|Systemic chemotherapy for colorectal liver metastases|Patients will receive disease-appropriate systemic chemotherapy for colorectal liver metastases (FOLFOX, FOLFIRI, or irinotecan/oxaliplatin, or panitumumab if KRAS/NRAS wild type)
15821036|NCT04276090|Drug|Systemic chemotherapy for intrahepatic cholangiocarcinoma|Patients will receive disease-appropriate systemic chemotherapy for intrahepatic cholangiocarcinoma (gemcitabine/oxaliplatin or gemcitabine alone)
15821037|NCT04276077|Other|High-frequency electrical muscle stimulation training|High-frequency electrical muscle stimulation training with 50 Hertz during 8 weeks
15821038|NCT04276077|Other|Low-frequency electrical muscle stimulation training|Low-frequency electrical muscle stimulation training with 10 Hertz during 8 weeks
15821039|NCT04276064|Device|Auditory closed-loop stimulation: slow oscillation boosting|Auditory-closed loop stimulation: slow oscillation boosting
15821040|NCT04276064|Device|Auditory closed-loop stimulation: slow oscillation disruption|Auditory closed-loop stimulation: slow oscillation disruption
15821041|NCT04276064|Device|Sham stimulation|Sham stimulation
15821042|NCT04276051|Device|Cryoablation of the Vagus Nerve|The Visual ICE Cryoablation System is a mobile console system intended for cryoablative tissue destruction using a minimally invasive procedure. The system is computer-controlled with a touch screen user interface. The therapy delivered by the system is based on the Joule-Thomson effect displayed by compressed gases. The Visual-ICE System uses high-pressure argon gas that circulates through closed-tip cryoablation needles to induce tissue freezing. Active tissue thawing is achieved by circulating helium gas through the needles or, alternatively, by the use of Galil Medical i-Thaw technology.
15821043|NCT04276051|Behavioral|Lifestyle Intervention|The lifestyle intervention structure will include three face-to-face counseling sessions at baseline, 3 and 6 months. Dietary counseling to follow a low carbohydrate diet will be provided by a registered dietitian. Focus will be on increasing fruits and vegetables and decreasing refined sugars and processed foods. It will also include motivational interviewing, goal setting and nutrition education. In addition, subjects will be encouraged by exercise physiologist to slowly increase physical activity to at least 150 minutes weekly. There will be weekly phone calls or texts (participants' choice) providing a total of 26 points of contact recommended by the United States Preventive Services Task Force.
15821044|NCT04276038|Device|B-Cure laser pro|The B-Cure laser pro is a portal, non-invasive, low level laser therapy device, that emits light in the near infrared (808nm) over an area of 1X4.5 cm2 with power output of 250mW, and energy dose of 1J/cm2. The device is used at home and is self-applied by the patient. The device is AMAR approved (approval # 14810408) for pain reduction and for ulcer treatment. The device is also approved for marketing in Canada and as a medical device in Europe (CE medical mark).
15821045|NCT04276025|Other|Clinical routine F18-FDG-PET/CT, molecular pathology and clinical outcome|Retrospective analysis of clinical routine F18-FDG-PET/CT, molecular pathology and clinical outcome data.
15821046|NCT04276012|Other|Multifactorial intervention|Psychoeducational intervention, recommendations on life style and diet, medication adherence and changes in pharmacological strategy
15821050|NCT04275986|Procedure|Intensity modulated radiotherapy (IMRT)|Intensity-modulated radiation therapy (IMRT) with a total dose of 45Gy in 25 fractions
15821051|NCT04275986|Drug|Chemotherapy|Nedaplatin 25 mg/m2 and Paclitaxel liposome 45mg/m2, day 1, every week, 5 weeks
15821052|NCT04275973|Device|Lower limb prostheses|"Standard commercially available prostheses for participants with lower-limb amputation.
~Specific prostheses will be determined at the time of the study, but they will include prostheses that are fully passive such as energy storage-and-return (ESR) feet, ESR feet with mobilized ankles such as passive hydraulic ankles (PHA), and ESR feet with microprocessor-controlled ankles (MPA)."
15821053|NCT04275973|Device|Orthoses for Drop-foot|Standard commercially-available orthoses or standard-of-care custom orthoses as well as standard commercially-available electrical stimulation neuro-orthoses.
15821054|NCT04275973|Device|Footwear|Different footwear will be used.
15821055|NCT04275960|Drug|Selitrectinib (BAY2731954)|Selitrectinib is administered orally as liquid suspension (20 mg/mL) on Day 1 of each period. Each period lasts 4 days, both periods of each arm are separated by at least 3 days.
15821056|NCT04275947|Other|nCapp, a cell phone-based auto-diagnosis system|Combined with 15 questions online, and a predicated formula to auto-diagnosis of the risk of COVID-19
15821057|NCT04275934|Behavioral|Health Management; Blood Pressure|Pharmacists will work with the patient/study subject, referred to as the participant hereafter, and the participant's other health care providers to manage their blood pressure, making recommendations for medication and lifestyle adjustments as needed.
15821058|NCT04275921|Diagnostic Test|MRI scan|MRI analysis using TWIST and HASTE
15821059|NCT04275921|Diagnostic Test|4D MRI|4D MRI alongside 4D CT in lung cancer
15821060|NCT04275908|Device|MHSAFE app|App to detect presence of mental state
15821149|NCT04275206|Other|Harkány medicinal water|The aim is to prove the effectiveness of Harkány medicinal water on patients suffering from psoriasis and rheumatoid arthritis. The control group is treated with tap water.
15821150|NCT04275206|Other|Tap water (placebo control)|The control group is treated with tap water.
15821151|NCT04275193|Drug|Zishenqing|Zishenqing Granule
15821061|NCT04275895|Behavioral|Evaluation of different attention or/and postural activities|"The children, equipped with a head-mounted display (HMD), will indicate as quickly as possible the direction of a fish that can be surrounded by congruent or not flankers (Inhibition) and/or preceded by signal (Alert)
~The children, equipped with a HMD and a joystick, will vertically turn a randomly inclined stick
~The children will stand on a force plate watching a cartoon, gazing a fixation cross or eyes closed
~The children, equipped with an augmented reality headset, will perform 2 levels of difficulty of 3 attention tasks standing on a force plate:
~They will click as quickly as possible when they see a frog among successively appearing animals (vigilance task)
~They will give the name of an animal appearing at one of the windows displayed (visual search task)
~They will count the number of yellow lions oriented to the right among several animals of different color and direction (inhibition task)
~Growth trajectory will be retrieved from health booklet"
15821062|NCT04275882|Diagnostic Test|Electrocardiogram|There will be no new intervention performed for the patients.
15821063|NCT04275869|Other|Healthy Lifestyle|A 3-month internet-based program focusing on the promotion of healthy lifestyles. The treatment protocol comprises 9 modules which incorporate psychological strategies to promote healthy lifestyles by gradually changing eating and physical activity habits.
15821064|NCT04275843|Dietary Supplement|Traditional Diet|Consuming an traditional whole foods based diet for 4 weeks.
15821065|NCT04275843|Dietary Supplement|Modern Diet|Consuming an processed formulation of the traditional diet for 4 weeks.
15821066|NCT04275830|Behavioral|Baseline Surveys|Baseline surveys contained a series of scaled questions, including sociodemographic variables (age, sex, cancer type, and etc), profile of mood states, social well-being, emotional processing and acceptance.
15821067|NCT04275830|Behavioral|Heart rate variability biofeedback|"Participants randomized to the intervention arm will receive exactly the same four digital stories via REDCap, a standardized HRV sensor and accompanying smart phone app, and a 30-minute HRVB training to use the biofeedback signals to generate a resonant frequency pattern of HRV (coherence) after collecting data at baseline in person. Participants will be given a take-home manual and specifically asked to practice their HRVB skills at home for 5 minutes prior to viewing stories once each week and upload a log of their time practiced to the cloud. The main purpose of adding HRVB practice as a priming experience (i.e., to teach participants to practice HRV prior to viewing stories) is to optimize results by focusing patients' and caregivers' skills and experience on HRV as a mechanism of improved emotion regulation, and then combine this achieved coherent pattern with DS intervention."
15821068|NCT04275830|Behavioral|Heart rate variability waitlist and Digital storytelling Control intervention|Four Digital Stories Intervention (4 patient stories about hematopoietic cell transplantation (HCT) over the course of 2 weeks (2 videos per week) with a weekly email notification and reminder phone call. Each story was made with voice, images, and sound (3-5 minutes each). The 4 digital stories patients produced contained the following content: (1) a leukemia patient expressed and controlled her depression and anxiety and described how she dealt with the intensive treatment and recovery through a positive attitude and active coping; (2) a mother of 3 children, who was experiencing severe pain due to MS, coped with HCT through family support and positive reframing; (3) a lymphoma patient coped with the HCT procedures by praying during the treatment; and (4) a father of young twins had a HCT twice, and his wife helped him cope with emotional distress through open communication and expressing emotions.Participants will receive a 30-minute HRVB training session at T2.
15821069|NCT04275817|Other|Data collection|Telephone interview questionnaire, in-home face-to-face interview, and data from the Collection Site
15821070|NCT04275804|Device|Low Magnitude High Frequence Vibration Platform|with low-magnitude high-frequency vibration (35Hz, 0.3g peak-to-peak displacement <0.1mm)
15821071|NCT04275804|Other|Conventional Dressing|Alternate Day Dressing
15821072|NCT04275791|Other|Triage|Experimental : Trauma patient orientation in a structured regional health organization, composed of trauma centers hierarchized in several levels according to their capacity to receive severe traumatized persons.
15821073|NCT04275778|Drug|Plaquenil 200Mg Tablet|Hydroxychloroquine will be taken at a dosage of 400 mg / day until delivery
15821074|NCT04275778|Drug|Placebo oral tablet|placebo will be taken at a dosage of 400 mg / day until delivery
15821075|NCT04275765|Behavioral|Arm 2:Behavioral Intervention with nudges & Facebook interaction|Participants will receive nudges and be enrolled to Facebook group for self-learning.
15821076|NCT04275765|Other|Arm 3: Community Intervention with individualised teleconferencing sessions and phone calls.|Participants will receive individualised teleconferencing sessions and phone calls by skilled midwives.
15821077|NCT04275752|Other|Exercise Program|Perform endurance (treadmill or cycle ergometer), strength (weight resistance), and flexibility training twice a week for a period of one hour per session, for a total of 16 sessions.
15821078|NCT04275739|Behavioral|Academic Episodic Future Thinking|Brief Academic goal related EFT intervention involving desirable outcomes of current academic goals
15821079|NCT04275739|Other|Vivid Memory Task|Matched for time control task involving recall of vivid memories of distinct events/actions from a children's story
15821080|NCT04275726|Device|Myval THV Series|The devices in the study are intended to improve aortic valve function for patients with severe symptomatic native aortic valve stenosis who are eligible for TAVR therapy. Every patient must be deemed treatable with an available size of both the test and contemporary heart valves approved for use and commercially available at the investigational centre where the implant procedure is being performed.
15821081|NCT04275726|Device|Contemporary Valves (Sapien THV Series and Evolut THV Series)|The devices in the study are intended to improve aortic valve function for patients with severe symptomatic native aortic valve stenosis who are eligible for TAVR therapy. Every patient must be deemed treatable with an available size of both the test and contemporary heart valves approved for use and commercially available at the investigational centre where the implant procedure is being performed.
15821082|NCT04275713|Drug|Metformin|Metformin is an oral antidiabetic drug
15821083|NCT04275713|Drug|Cisplatin|Cisplatin 40 mg/m2 given intravenously once a week, maximum 6 cycles
15821084|NCT04275700|Procedure|A-PRP|The cortex of each ovary will be injected with autologous platelet rich plasma. Up to seven different sites will be injected under ultrasound guidance. The patient will be under IV sedation.
15821152|NCT04275193|Drug|Placebo|Granule manufactured to mimic Zishenqing(containing 10% composition)
15821153|NCT04275180|Drug|Argatroban|Argatroban plus standard medical treatment
15821085|NCT04275687|Radiation|thoracic irradiation|"For peripherally located recurrent tumors, stereotactic body radiation therapy is used at 5000-6000 cGy in 10 fractions.
~For centrally located recurrent tumors, adaptive hypofractionated radiation is used: Patients are irradiated at 3000-4000cGy in 6-10 daily fractions in the first course. After a four-week interval, patients who have non-progressive disease and an adequate pulmonary function undergo adaptive re-planning, and are irradiated at 2400-3500cGy in 4~7 daily fractions as a boost."
15821086|NCT04275687|Drug|Concurrent chemotherapy|For centrally located recurrent tumors, concurrent chemotherapy consists of weekly docetaxel and nedaplatin.
15821087|NCT04275661|Procedure|Ultrasound (US) bi-level erector spinae block|nerve block
15821088|NCT04275661|Drug|levobupivacaine|20 ml 0.25% levobupivacaine injected into fascial plane deep to erector spinae muscle
15821089|NCT04275661|Drug|Ketamine|2 mg /kg ketamine.injected into fascial plane deep to erector spinae muscle
15821090|NCT04275661|Drug|Magnesium Sulfate|2mg/kg Magnesium Sulfate .injected into fascial plane deep to erector spinae muscle
15821091|NCT04275648|Diagnostic Test|AsthmaTuner exercise field test|AsthmaTuner consist of a a bluetooth spirometer and smartphone app with protocol for measuring lung function (FEV1) and perform 8 min exercise challenge test and a healthcare web interface.
15821092|NCT04275635|Device|Orthokeratology lenses|Orthokeratology lenses
15821093|NCT04275622|Behavioral|Lifestyle including optimal exercise and diet modification.|The intervention group will receive diet education and be given exercise suggestion.
15821094|NCT04275609|Other|AI generated report|After the endoscopic procedure, the physicians click the structured reporting button of computer to automatically complete the report through the structured diagnostic report generation system. The physicians only make minor corrections to the report.
15821095|NCT04275609|Other|physicians writing report|After the endoscopic procedure, the physicians writing the report in computer according the procedure.
15821096|NCT04275596|Drug|2QR complex|Application of topical gel containing 2QR complex on the anal wound until complete wound healing
15821097|NCT04275596|Drug|Placebo|Application of topical placebo on the anal wound until complete wound healing
15821098|NCT04275583|Drug|TQB3602|This is a kind of proteasome inhibitor.
15821099|NCT04275570|Behavioral|Motivational interview|The motivational interview is integrated in a structural theoretical mark. This method is a person-centered counseling style that increases the intrinsic motivation of the patient to behavioral changes through spirit, acceptance, compassion and evocation.
15821100|NCT04275557|Other|Blood Sample collection|Participants will be asked to donate blood at baseline (+/- 30 days of diagnosis date), 4-6 weeks post-surgery, if applicable, and at the time of follow-up (approximately 1 year and approximately 2 years after baseline).
15821101|NCT04275557|Other|Tissue sample collection|At the time of tissue biopsy and surgical resection (if applicable), pancreatic tumor tissue, muscle, fat, tissue from site of metastasis, and cyst fluid (if applicable) will be collected.
15821102|NCT04275557|Other|Data collection|Participants will be asked to complete questionnaires at baseline and at 1 year and 2 year follow-ups.
15821104|NCT04275518|Drug|APG-115|APG-115 orally once daily from Days 1 to 7 every 28 days.
15821105|NCT04275518|Drug|Azacitidine|75 mg/m^2 SC QD on Days 1- 7 (28-day cycle)
15821106|NCT04275518|Drug|Cytarabine|1g/m^2 IV QD on Days 3-7 (28-day cycle)
15821107|NCT04275505|Other|shortwave diathermy treatment|shortwave diathermy is a deep heating physical therapy agent. It was found efficiaous in carpal tunnel syndrome which is an entrapment neuropathy like ulnar nerve entrapment so it was hypothesised that shortwave diathermy could be an effective treatment method in ulnar nerve entrapment.
15821108|NCT04275505|Other|placebo shortwave diathermy treatment|shortwave device was not turned on while participants were asked to put their elbow into the device
15821109|NCT04275492|Drug|Praxol hydrochloride sustained release tablet Specification: 0.375mg/ tablet (in pramipexole hydrochloride)|Praxol hydrochloride sustained release tablets, 0.375mg/ tablet, are manufactured by hongguanbio pharmaceutical co., LTD
15821110|NCT04275492|Drug|Pramipexole hydrochloride sustained-release tablet (Siforl®) Specification: 0.26mg/ tablet (in pramipexole)|Siforl® is produced by Boehringer Ingelheim International Gmbh
15821111|NCT04275479|Diagnostic Test|Oral Glucose Tolerance Test|This is a two step process. Subjects will be asked to fast overnight,(no food and only water to drink for at least 8 hours). Then when subjects arrive for the visit,participants will have blood drawn and be asked to drink a sugary liquid. One hour later, another blood sample will be drawn and after two hours a final blood sample will be drawn.
15821112|NCT04275479|Other|Modified Oral Glucose Tolerance Test|The participant will be asked to fast overnight (no food and only water to drink for at least 8 hours). There will be no blood drawn during this test, participant will be asked to drink a sugary liquid and to remaining fasting (water only) for the two hour after finishing the drink.
15821113|NCT04275479|Other|Modified Mixed Meal Tolerance Test|The participant will be asked to fast overnight (no food and only water to drink for at least 8 hours). The participant will be given a meal supplement to drink in place of breakfast, for example Boost Plus. The participant will be asked to drink the meal supplement and to remaining fasting (water only) for the next two hours.
15821114|NCT04275479|Device|Continuous Glucose Monitor|The participant will be provided a CGM device to wear for 10 days during the study period. The CGM will be blinded (meaning that the participant will not be able to see the results).
15821115|NCT04275479|Other|Food Diary|The participant will be asked to maintain a detailed food diary for 3 days during the 10 day study period.
15821116|NCT04275479|Other|Medical History Questionnaires|The participant will be asked to provide detailed medical history
15821144|NCT04275258|Other|Provide assistance to subject's rural PCP pertaining to subject/patient pain management goals and opioid taper plan|"PA checks in with PCP at 1,2,4,8, 12, 16, and 20 weeks post hospital discharge by secure e-mail, fax or phone to provide opioid taper and pain management guidance until patient has tapered off opioids or returned to pre-trauma doses. PCP may contact PA whenever needed.
~If PCP requests assistance or reports deviation from the planned opioid taper, PA will provide individualized consultations, which may include a revised taper plan and/or adjunctive therapy recommendations.
~If there is continued deviation from the planned taper, the PA will facilitate a UW TelePain multidisciplinary telemedicine consultation.
~The collaborative pain care and opioid taper intervention ends at 20 weeks."
15821117|NCT04275466|Procedure|necrotic cavity lavage|"At least two 30- to 36-Fr drainage tubes will be placed into each necrotic cavity. One of these drainage tubes will be used as the lavage tube; the other tube is designed for drainage.
~Lavage will begin on the first day after debridement, and the relevant indices will be evaluated every 7 days to decide whether to continue the lavage.
~1200 mL of normal saline will be lavaged into each necrotic cavity every day at a speed of 200 mL/h for 3 hours each time and for a total of two times. The start times of lavage will be 08:00 and 20:00.
~The lavage and drainage volumes of the first hour and second hour of each lavage session will be calculated. The lavage of the next hour will be stopped if the lavage volume minus the drainage volume is >100 mL.
~Lavage will be suspended if abdominal pain and distention occur, the maximum body temperature is >38.5ºC, or the abdominal pressure is ≥15 mmHg during the lavage procedure."
15821118|NCT04275453|Drug|FDG|FDG is a FDA approved radiotracer which each subject will have 3 positron emission tomography/computed tomography (PET/CT) scan performed.
15821119|NCT04275453|Dietary Supplement|Ketone Drink|Subjects will undergo FDG PET/CT after 1 dose of ketone drink administration after 12 hours of fasting prior to FDG injection. The dosing of ketone drink administration (approximately 65 mL) will be weight based (714 mg/kg), which is crucial to replicating ketone levels between participants
15821120|NCT04275453|Other|Ketogenetic Diet|Subjects needs to be on Ketogenetic diet
15821121|NCT04275440|Behavioral|Exercise|Rope-skipping exercise for three times a week (90 minutes each time, and there is a 10 min break after 20 min Rope skipping). Exercise bracelet and smart bracelet would be used to record the energy consumption throughout the study.
15821122|NCT04275440|Behavioral|Caloric restriction|"In the first two weeks, participants would reduce their daily energy intake to 100% -110% of his or her basal metabolic energy under instruction, and stick to it till the end of the intervention.
~According to the dietary recommendation proposed by Chinese government, participants are required to take in cereals, vegetables, fruits, meat and eggs, while minimize the consumption of sugar-sweeten beverages.
~Participants are instructed to arrange their three meals according to the recommended energy distribution (3:4:3)."
15821123|NCT04275427|Device|LA-400 laser acupuncture|low level laser
15821124|NCT04275414|Drug|Bevacizumab Injection|Bevacizumab 500mg + normal saline (NS) 100ml, ivdrip ≥90min
15821125|NCT04275388|Drug|Xiyanping injection|Xiyanping injection, 10-20ml daily, Qd, the maximum daily does not exceed 500mg (20mL) + Lopinavir tablet /Ritonavir tablet or Alpha-interferon nebulization or Abidor Hydrochloride,
15821126|NCT04275388|Drug|Lopinavir / ritonavir, alpha-interferon nebulization,Abidor Hydrochloride|Lopinavir / ritonavir tablets, 2 times a day, 2 tablets at a time; alpha-interferon nebulization;Abidor Hydrochloride
15821127|NCT04275375|Other|observation study about the autonomic response after spinal anesthesia|ECG waveforms were continuously recorded using a multichannel polygraphic system (Embla N7000, Natus, Pleasanton, CA). The data were saved at a rate of 1024 Hz directly to a memory card within the device for offline analysis of heart rate variability (HRV) and PPG. All data included in the analysis were obtained from continuous artifact-free ECG recordings for analysis of the immediate effects of spinal anesthesia.
15821128|NCT04275362|Device|DJO Empowr PS Knee System|Patients will receive a DJO Empowr PS Knee System total knee replacement
15821129|NCT04275362|Device|Stryker Triathlon Total Knee System|Patients received a Stryker Triathlon Total Knee System total knee replacement
15821130|NCT04275362|Device|Biomet Vanguard Complete Knee System|Patients received a Biomet Vanguard Complete Knee System total knee replacement
15821131|NCT04275362|Device|Control|No total knee replacement
15821132|NCT04275349|Drug|Xingnaojing injection within 24 hours of symptom onset|intravenously administered Xingnaojing injection within 24 hours of symptom onset on ambulance or at hospital
15821133|NCT04275336|Drug|EMLA application|A thick layer of cream (lidocaine and propiocaine 2.5%/2.5%) will be applied on a 1x1 cm2 area of skin on the cannulation site. The transparent dressing will be left in place for 30 minutes, then remove and clean with a sterile cotton swab. Then nurse perform IV cannulation for them.
15821134|NCT04275336|Behavioral|Distraction techniques|Multiple distractions including toy whistles, cartoon books, a TV showing cartoons, and various electronic products with video games will be provided for the children to choose and play with. They will also be taught breathing exercises (i.e. inhaling through the nose for 3 seconds and exhaling for 5 seconds, while they are counting) if they are willing. A play therapist play with the children for 5 min. prior to and throughout the venipuncture procedure.
15821135|NCT04275336|Other|EMLA cream and distraction techniques|both EMLA cream and distraction techniques will be used. EMLA cream will be applied on the pre-puncture site for 30 minutes as the EMLA group, then 5 minutes before the venipuncture, the play therapist encourage them to choose their favorite toys to play with or to learn breathing exercises. During IV cannulation the play therapist will also continue distracting the child with toys.
15821136|NCT04275323|Genetic|NL003|Day 0: 8mg of NL003 (32 injections of 0.5ml of NL003) Day 14: 8mg of NL003 (32 injections of 0.5ml of NL003) Day 28: 8mg of NL003 (32 injections of 0.5ml of NL003)
15821137|NCT04275323|Other|Normal Saline|Day 0: 16ml of Normal Saline (32 injections ) Day 14: 16ml of Normal Saline (32 injections ) Day 28: 16ml of Normal Saline (32 injections )
15821138|NCT04275310|Behavioral|Microeconomic Intervention|The intervention will consist of six sessions on six different days. Sessions will be held at VCU or at one of VCU's community partners. Each session will last for around 2 ½ hours (around 15 hours total). There will be breaks and food will be provided. During the sessions the facilitators will provide education on a variety of topics, including economic services that are available to people living in Richmond, job skills (such as creating a resume and dealing with discrimination at work), personal finance education, gender transition ideas, and HIV prevention. The sessions will occur in a group of about 4-10 transgender women.
15821139|NCT04275297|Behavioral|Psychosocial Treatment|The psychosocial intervention will consist of 8 weekly 50-minute individual visits with the assigned therapist.
15821140|NCT04275297|Behavioral|Attention Control|The Attention Control will reflect a similar visit pattern and duration as intervention sessions.
15821141|NCT04275284|Biological|PCV10|0.5 ml injection
15821142|NCT04275284|Biological|PCV13|0.5 ml injection
15821143|NCT04275271|Behavioral|Educational intervention|Skill centered Protocol Training based on IMB model
15821145|NCT04275245|Drug|Meplazumab for Injection|humanized MAb against CD147
15821288|NCT04273919|Device|HTC Vive with Lumen Program|HTC Vive head-mounted display with Lumen program
15821154|NCT04275167|Device|Tethered Capsule Endomicroscope/Trans Nasal Endomicroscope|All particpants are asked to swallow our capsule device. If swallowed the capsule will naturally be moved to the duodenum via peristalsis. Once there we will slowly move the tether on the capsule up and down to gain OCT images of the duodenum.
15821155|NCT04275141|Other|oral glucose load|oral glucose load (60g) followed by
15821156|NCT04275141|Other|exercise test|exercise at fixed wattage (70W/60W) for 45 min
15821157|NCT04275128|Device|Cooled radiofrequency ablation|Cooled radiofrequency thermal treatment uses the electrical current produced by radio waves to destroy a part of nerve tissue and relieve pain.
15821158|NCT04275128|Device|Conventional radiofrequency ablation|Genicular nerve ablation involves using radiofrequency to heat up the genicular nerve until it dies, causing relief of pain. This is a minimally invasive treatment that does not require any medication.
15821159|NCT04275115|Drug|Drug Cocktail|Single oral dose of the cocktail probe substrates (caffeine 200 mg, montelukast 10 mg, midazolam 4 mg)
15821160|NCT04275115|Drug|Foliglurax|Foliglurax
15821161|NCT04275115|Drug|midazolam iv|Single intravenous (iv) dose of midazolam 0.025 mg/kg
15821162|NCT04275102|Other|SPARK|Prompt to complete symptom screening three times weekly via SPARK with corresponding feedback sent to healthcare providers with each completed assessment.
15821163|NCT04275089|Device|Reia Vaginal Pessary|Reia Vaginal Pessary
15821164|NCT04275076|Procedure|Holmium laser enucleation of the prostate versus bipolar transurethral enucleation of the prostate in management of benign prostatic hyperplasia|comparison between 2 energy sources of enucleation in management of benign prostatic hyperplasia, holmium laser versus bipolar energy source in trans-urethral enucleation of the prostate
15821165|NCT04275050|Drug|TQB3303|TQB3303 tablet is a small molecule oral drug inhibiting cyclin-dependent kinases 4 and 6 (CDK4 / 6).
15821166|NCT04275037|Other|Isometric Handgrip Training|The 8-week exercise program will include three sessions of isometric handgrip training per week
15821167|NCT04275037|Other|Aerobic Exercise Training|The 8-week exercise program will include three sessions of aerobic exercise per week
15821168|NCT04275024|Drug|Calcipotriol ointment|The topical treatment in the study was calcipotriol ointment(Dovonex;LEO Laboratories Ltd, Ireland) twice daily for 12 weeks.
15821169|NCT04275024|Drug|PSORI-CM01 Granule|PSORI-CM01#YXBCM01# granule 5.5g os once a day for 12weeks.
15821170|NCT04275024|Biological|adipose-derived multipotent mesenchymal stem cells|AD-MSCs(adipose-derived multipotent mesenchymal stem cells) were infused intravenously at a dose of 2 million cells/kg
15821171|NCT04275011|Other|Progressive Resistance and Impact Exercise|Full body resistance and impact exercises will be performed twice a week for 30-45 minutes over a 6 month period. There will be at least one day of rest between scheduled exercise sessions. Participants will be individually prescribed variations of push, pull, squat, lift and carry movements targeting major muscle groups that they can safely complete, and accessory exercises to help develop movement patterns. Exercises will challenge both the upper and lower body using functional movement patterns. Each muscle group will be trained twice a week. During the first month, participants will focus on completing exercises with good form at a low intensity. Once form is mastered, exercises will be progressed (by increasing load, or challenge of the movement) to a moderate to high exercise intensity (80-85% 1RM) so that the participant can complete a maximum of 8 (~80% 1RM) or 6 (~85% 1RM) repetitions with 1-2 repetitions in reserve for 3 sets at a rating of perceived exertion (RPE) of 8-9.
15821172|NCT04275011|Other|Static Balance and Postural Exercise|Participants in the attention control group will perform static posture and balance exercises (e.g., low intensity yoga poses) and will be given the same attention as the participants in the intervention group. The small group exercises will be performed twice a week, 30-45 minutes per session, over 6 months, with at least one day of rest between each session. The exercise program will be supervised by a certified personal trainer and yoga instructor who is BoneFit trained.
15821173|NCT04274998|Drug|[11C]PBR28 and[18F]NOS|PET/CT imaging will be used to evaluate neuroinflammation in the brain using the investigational radiotracer [11C]PBR28 followed by a second investigational radiotracer [18F]NOS. Each subject will have two positron emission tomography/computed tomography (PET/CT) scan sessions performed on the same day, first with [11C]PBR28 followed by [18F]NOS.
15821174|NCT04274985|Other|Questionnaire application|Patients will complete the mentioned questionnaires.
15821175|NCT04274972|Diagnostic Test|Microbiome evaluation|The oral and rectal microbiome samples will be collected preoperatively. The PDAC tissue from the surgical specimen, the intestinal mucosal tissue from the enteric side of the pancreatic anastomosis, and the bile sample will be collected intraoperatively. On the 30th postoperative day, the oral and rectal samples will be repeated
15821176|NCT04274959|Other|ceramic onlay with shoulder preparation design.|ceramic onlay with shoulder preparation design which allowing the largest possible enamel for adhesion ,
15821177|NCT04274959|Other|,ceramic onlay with butt joint preparation design|ceramic onlay with butt joint preparation design with cusp reduction to protect teeth from occlusal loads and cuspal fracture
15821178|NCT04274946|Procedure|Sentinel lymph node biopsy|Sentinel lymph node biopsy(SLNB) procedure with different mapping methods using combination of radioactive colloid, patent blue, indocyanine green associated with intraoperative ultrasound.
15821179|NCT04274933|Drug|Venetoclax|Tablet; Oral
15821180|NCT04274933|Drug|Capecitabine|Tablet; Oral
15821181|NCT04274920|Other|Bioactive Glass|Bioactive glass was incorporated in resin composite and its adhesive
15821182|NCT04274920|Other|Light cured calcium hydroxide|Light cured calcium hydroxide
15821183|NCT04274907|Drug|Venetoclax|Tablet: Oral
15821184|NCT04274907|Drug|Pembrolizumab|Intravenous (IV) Infusion
15821185|NCT04274894|Drug|AndroGel 1.62%|Topical Gel
15821186|NCT04274881|Procedure|Catheterization of internal jugular vein|"The right internal jugular vein will be cannulated under transesophageal echocardiographic (TEE) guidance in order to place the catheter tip in the mid-SVC.
~The length of the catheter required to place the tip at the mid-SVC as guided by TEE will be regressed on the C-length or on the distance from the entry point to the surface point corresponding to the mid-SVC on the chest wall in order to obtain a predictive equation.
~The accuracy of either equation will be assessed by estimation of the standard error of the estimate (SEest)."
15821187|NCT04274842|Other|observation by D-OCT|observation by D-OCT before, after, 1-3 days after, and 1 month after IPL treatment
15821188|NCT04274829|Procedure|Thyroidecomt and lymphectomy|Patients underwent total thyroidectomy or lobectomy associated to lymph node sampling or neck lymphectomy
15821189|NCT04274816|Drug|Tremelimumab|Intradermal injection of tremelimumab 7 days prior to sentinel node biopsy, with escalating doses of 2, 5, 10 or 20 mg tremelimumab (3 patients per dose level with an expansion at the optimal dose level with an additional 5 patients).
15821190|NCT04274803|Drug|Intralipid, 20% Intravenous Emulsion|intralipid 20% (Frezenius, Clayton, NC, USA) in a dose of 4 ml diluted in 250 ml 0.9% regular saline to be infused IV and to be repeated every 2 weeks all over the pregnancy.
15821191|NCT04274803|Drug|Conventional therapy of antiphospholipis syndrome|the conventional basic treatment of APS (Dual low dose aspirin (LDA) (Ezacard 75mg) once daily and Low molecular weight heparin (LMWH) (clexane 4000 IU) injection once daily.
15821192|NCT04274790|Procedure|Scheduled and planned surgery|Collection of tumour samples from samples collected as part of standard patient management. Diagnostic pathological analysis will be a priority. These samples will be taken by experienced staff during the hospital visit scheduled as part of standard care.
15821193|NCT04274764|Behavioral|Personalized eHealth Education & Motivational Interviewing|This intervention uses a web-based application to generate personalized education materials for patients based on their eye health screening results and barriers to follow up care. A glaucoma counselor trained in brief, glaucoma-specific motivational interviewing (MI) uses the individualized content generated from this web- based application to form the basis of her conversation with the patient to coach the patient to engage in follow-up care.
15821195|NCT04274738|Drug|Mavorixafor|Mavorixafor capsules will be administered per dose and schedule specified in the arm.
15821196|NCT04274738|Drug|Ibrutinib|Ibrutinib capsules will be administered per dose and schedule specified in the arm.
15821197|NCT04274712|Diagnostic Test|INNOGRAFT Heart Suite|Liquid biopsy to identify acute rejection
15821198|NCT04274699|Diagnostic Test|Hemosonics Quantra coagulation monitor|There is no categorisation or allocation of any subject to any intervention vs non-intervention group. Blood sampling and the addition of a Quantra coagulation test is the only 'intervention', and the sampling protocol is identical for all subjects. Post-testing treatment of all subjects is as per established routine and Quantra results will not be used by clinical team.
15821199|NCT04274686|Device|Tegaderm placement|Placement of perforated Tegaderm bandage over lower face, with diamond-shaped hole aligned with the patient's mouth, for use during bag-mask ventilation
15821200|NCT04274686|Other|No Tegaderm|Bag-mask ventilation performed in ordinary fashion, without use of Tegaderm bandage
15821201|NCT04274673|Device|measuring cotinine level|Measuring of the cotinine levels
15821202|NCT04274660|Behavioral|DWELL (Diabetes and WELLbeing) Programme|12-week psychoeducational programme
15821203|NCT04274647|Device|NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, LOW DERMATITIS POTENTIAL, TESTED FOR USE WITH CHEMOTHERAPY DRUGS - BLUE|Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact.
15821204|NCT04274608|Drug|Botulinum toxin type A|Intragastric injection of Botulinum toxin type A
15821205|NCT04274608|Behavioral|Weight Management Program|12 week weight management program
15821206|NCT04274595|Drug|Generic antiretroviral|200mg emtricitabine plus 245mg tenofovir diisopropyl fumarate for 7 days
15821207|NCT04274582|Dietary Supplement|chokeberry extract|The players received 30 mL of liquid chokeberry extract, in the morning before training, once per day for 12 weeks.
15821208|NCT04274569|Other|NaF vanish|A disposable micro-brush will be used to apply the varnishes to all tooth surfaces. The fluoride varnish will be applied every 3 months, from baseline to 24-months follow-up.
15821209|NCT04274569|Other|NaF-TCP|A disposable micro-brush will be used to apply the varnishes to all tooth surfaces. The fluoride varnish will be applied every 3 months, from baseline to 24-months follow-up.
15821210|NCT04274569|Other|NaF-CPP-ACP|A disposable micro-brush will be used to apply the varnishes to all tooth surfaces. The fluoride varnish will be applied every 3 months, from baseline to 24-months follow-up.
15821211|NCT04274556|Other|Post-dialysis recovery group|Before the hemodialysis session, the patients were asked by the investigators how long it took them to recover from a dialysis session, taking the last treatment month into account.
15821212|NCT04274543|Device|Lipogems|The Lipogems system (Lipogems International SpA, Milan, Italy) is designed to isolate autologous, micro-fragmented adipose tissue without enzymes or other additives. It uses mild mechanical forces to break down adipose tissue that is extracted from the patient into a form that can be injected into the meniscal lesion and other degenerated tissues in a sterile and safe manner. The resulting product is rich in pericytes and mesenchymal stromal cells, retained within an intact stromal vascular niche, that is ready for use in clinical applications.
15821213|NCT04274543|Drug|Normal Saline|"Normal Saline solution is a mixture of sodium chloride in water (9 g NaCl per liter water, 0.9% saline). Trephination allows for vascular growth and healing, especially in the inner avascular regions of the meniscus, by puncturing the meniscus. Small tunnels are created, which allow for healing factors to reach the avascular inner region of the meniscus from the vascular peripheral regions."
15821214|NCT04274530|Behavioral|Cognitive Behavioural Therapy|Participants who are randomized to the CBT intervention will be encouraged to begin CBT immediately following randomization. The CBT intervention will focus on addressing maladaptive beliefs related to pain and recovery as well as teaching skills to enhance coping and management of pain symptoms. The specific focus of CBT sessions will be informed by each individual patient's responses to baseline questionnaires. All other aspects of post-operative care will be at the discretion of participant's surgeon.
15821215|NCT04274517|Other|Sterile Water|1L of sterile water used in surgical splash basins during total joint arthroplasty to clean surgical instrumentation.
15821216|NCT04274517|Other|3.5% Betadine|1L of 3.5% betadine used in surgical splash basins during total joint arthroplasty to clean surgical instrumentation.
15821217|NCT04274517|Other|0.05% Chlorhexidine Gluconate|1L of clorhexidine gluconate used in surgical splash basins during total joint arthroplasty to clean surgical instrumentation.
15821218|NCT04274504|Diagnostic Test|Osteopontin|Serum osteopontin (OPN) was measured by ELIZA and osteopontin gene mutation was analyzed by sequencing and correlated with clinicopathological criteria, response, PFS and OS.
15821219|NCT04274478|Device|Auditive cueing|Based on gait measurement, auditive cueing is generated automatically to check its impact on patients with Freezing Of Gait.
15821221|NCT04274452|Biological|efgartigimod|Intravenous infusion of efgartigimod
15821222|NCT04274452|Other|Placebo|Intravenous infusion of placebo
15821223|NCT04274439|Other|Internet-Based Pain Education and Exercise|Telerehabilitation is defined as providing techniques for therapeutic rehabilitation remotely or off-site using telecommunication technologies. Thus, our intervention will be based on the use of a website created and registered especially for the study that will have the shooting of 1 video of pain education and 1 video of exercises for the subjects of the study, totaling 8 videos of pain education and 8 exercise videos. We will provide complimentary materials along with the triggered videos and a booklet of chronic pain information. We will also make weekly calls for a health coaching service and the sending of smartphone messages for the motivation and accountability of the subjects.
15821224|NCT04274439|Other|Online Booklet|An online booklet containing information about chronic pain and suggestions for lifestyle modifications and behavior will be delivered, as well as an incentive to perform physical exercises.
15821225|NCT04274426|Drug|Carboplatin|Carboplatin will administered by intravenous route
15821226|NCT04274426|Drug|Pegylated liposomal doxorubicin (PLD)|PLD will be administered by intravenous route
15821227|NCT04274426|Drug|Gemcitabine|Gemcitabine will be administered by intravenous route
15821228|NCT04274426|Drug|Paclitaxel|Paclitaxel will be administered by intravenous route
15821229|NCT04274426|Drug|Mirvetuximab Soravtansine|Mirvetuximab Soravtansine will be administered by intravenous route
15821230|NCT04274413|Combination Product|Beta Adrenergic Sweat Test|"In Beta Sweat Test - sweat secretion will be stimulated by injecting a series of drugs within the skin surface. Small needles will be used to inject minute amounts of each drug. Before and after each skin injection, the skin will be cleaned using an alcohol swab.
~Two sensor probes will be strapped to the forearm with rubber bands in position just above the injection site.
~Under the first probe, injection atropine will be given in one small area of the skin.
~Under the second probe, first injection carbachol will be given in one small area of the skin.
~Next, at the second probe area, the normal sweating will be stopped for awhile by injecting a drug called atropine.
~Lastly, beta-adrenergic sweating will be stimulated by injecting a combination of the following drugs: atropine, isoproterenol, and aminophylline (β-cocktail). Using probes, all sweat rate readings will be recorded."
15821231|NCT04274387|Behavioral|Mindfulness-based Stress Reduction(MBSR)|A structural program focusing on the practice about attending to the current moment with non-judgmental attitude
15821232|NCT04274374|Dietary Supplement|Gluten-Free Diet|Dietary supplement without gluten
15821233|NCT04274374|Dietary Supplement|Gluten Diet|Dietary supplement with gluten
15821234|NCT04274361|Drug|Ketamine|Ketamine infusion
15821235|NCT04274361|Drug|Placebo|Placebo infusion
15821236|NCT04274348|Other|Skin biopsies and blood samples|Two skin biopsies and 30 ml of blood will be collected.
15821237|NCT04274335|Drug|Tranexamic Acid 100Mg/Ml Inj Vil 10Ml|1 gram of tranexamic acid to be administered intravenously
15821238|NCT04274335|Drug|Tranexamic Acid Oral Solution|4 grams of tranexamic acid given as an oral solution
15821239|NCT04274335|Drug|Tranexamic Acid Injectable Product|1 gram of tranexamic acid given as 2 separate intramuscular injection
15821240|NCT04274322|Other|Nutrition support|Calories and proteins are given to patients by using ways as parenteral nutriton, enteral nutrition, oral nutrition supplement
15821241|NCT04274309|Device|EndoSWIR|Exposition of the respected tissues to the camera
15821242|NCT04274296|Device|Activation of Advisory|Advisory is activated which will show if driving pressure is greater or equal 15
15821243|NCT04274283|Other|Matched Tumour and Blood Sample|"For patient's undergoing surgery fresh tissue will be collected from the initial surgery and frozen until shipment to the Oxford BRAIN MATRIX Lab. Matched blood sample for germline DNA will be taken post-Platform Study entry. For patients with progression with available tumour samples from previous tumour surgery, blood will be collected and sent to Oxford along with their tumour samples.
~Samples will be shipped together to Oxford for molecular analysis (Whole Genome Sequencing (WGS) and EPIC array). The BRAIN MATRIX neuropathology and genomics team will produce an integrated report (histology, WGS, Heidelberg Classifier) for each case in consultation with the local neuropathology team. Once data is available, a virtual MDT with the BRAIN MATRIX neuropathology, genomics team and local site will be held to ensure all relevant information is incorporated in the final BRAIN MATRIX diagnostic report, The resulting integrated histological-molecular report will be available to local sites."
15821244|NCT04274270|Drug|Endostar|Radiotherapy was performed with a cyberknife or accelerator stereotactic radiotherapy, which lasted 3-10 days.After the end of radiotherapy,S1 60mg, BID, day 1-28, as taken orally, and repeated every 6 weeks, with concurrent Endostar therapy: 210mg was used by intravenous infusion for 7 consecutive days during each cycle of chemotherapy, and 30mg was used every 24 hours.
15821245|NCT04274257|Drug|Double-Blind Placebo|"The 4-week treatment period (four 375 mg/m2 doses at 1-week intervals) and subsequent 20-week follow-up period constitute one cycle of treatment.
~In the double-blind period, one cycle of placebo will be administered. In the active drug period, one additional cycle (rituximab) will be administered."
15821246|NCT04274257|Drug|Double-Blind Rituximab|"The 4-week treatment period (four 375 mg/m2 doses at 1-week intervals) and subsequent 20-week follow-up period constitute one cycle of treatment.
~In the double-blind period, one cycle of rituximab will be administered. In the active drug period, one additional cycle (rituximab) will be administered."
15821286|NCT04273932|Drug|Lithium|Lithium aspartate of lithium carbonate will be administered by mouth.
15821287|NCT04273919|Device|HTC Vive with Karuna Virtual Reality Program|HTC Vive head-mounted display and an HTC Vive body tracker adhered to a belt on the patient's low back, which will be placed 2 inches below the waist
15821247|NCT04274244|Drug|Cross-Linked Hyaluronate Gel Prefilled Syringe 30 MG/3ML|"Regenerative periodontal therapy + Cross-linked hyaluronic acid 1.8%:
~The modified minimal invasive surgical technique, described by Cortellini 2011, will be used to raise the interdental papilla over the bone defect.
~Measurement of bone defect with a 0.5mm periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Illinois, USA) to characterize the defect anatomy.
~Inflammatory tissue will be debrided and the root carefully planed using Gracey curettes.
~The site will be washed with physiologic sterile solution, dried and the root wil be conditioned with 24% Ethylenediamine tetraacetic acid (EDTA) for two minutes, then the defect area will be carefully rinsed with sterile saline to remove any residual EDTA.
~Application of Hyadent BG® 1,8% filling the bone defect from the bottom upwards in the test group.
~Single internal modified mattress suture (5/0 Vicryl, Ethicon).
~Sutures will be removed after two weeks."
15821248|NCT04274244|Drug|Enamel Matrix Proteins (Active comparator group)|"Regenerative periodontal therapy + Enamel matrix proteins:
~The modified minimal invasive surgical technique, described by Cortellini 2011, will be used to raise the interdental papilla over the bone defect.
~Measurement of bone defect with a 0.5mm periodontal probe (PCP-UNC 15, Hu-Friedy Manufacturing, Illinois, USA) to characterize the defect anatomy.
~Inflammatory tissue will be debrided and the root carefully planed using Gracey curettes.
~The site will be washed with physiologic sterile solution, dried and the root wil be conditioned with 24% Ethylenediamine tetraacetic acid (EDTA) for two minutes, then the defect area will be carefully rinsed with sterile saline to remove any residual EDTA.
~Application of Emdogain® filling the bone defect from the bottom upwards in the active comparator group.
~Single internal modified mattress suture (5/0 Vicryl, Ethicon).
~Sutures will be removed after two weeks."
15821249|NCT04274231|Genetic|different effection|Analysis of the reasons for treatment
15821250|NCT04274218|Other|Perturbation|Participants from both cohorts will experience a simulated trip while walking on the treadmill. The trip is induced through a rapid acceleration and deceleration of the treadmill belt speed.
15821251|NCT04274205|Other|Intervention group|Brief supportive psychotherapy
15821252|NCT04274192|Other|Synchronized HFNC|HFNC given in synchrony with the subject's own respiratory effort using NAVA
15821253|NCT04274192|Other|Continuous HFNC|Standard HFNC therapy
15821254|NCT04274179|Other|Modified Atkins Diet|Low carb (20g/day), high fat, moderate protein diet. Started as an outpatient in clinic.
15821255|NCT04274179|Drug|Absence epilepsy medications|At neurologist's discretion
15821256|NCT04274166|Drug|secukinumab 150 mg (2 injections per dose|secukinumab 150 mg (2 injections per dose
15821257|NCT04274153|Biological|Gardasil9|Two doses of the HPV vaccine across a 12 month period (two doses of 0.5mL).
15821258|NCT04274127|Diagnostic Test|early detection kit composed of 2 questionnaires (M-CHAT-R + CSBS-ITC)|completion of 2 questionnaires (M-CHAT-R + CSBS-ITC) followed by a confirmation of the detection with a phone call by a neuropsychologist, in children aged 16 to 24 months seen by their usual general practitioner or pediatrician or child care centers or attending nurseries.
15821259|NCT04274114|Drug|L Glutamine|Powder
15821260|NCT04274114|Drug|Placebos|Powder
15821261|NCT04274101|Other|Clinical Manifestations|Clinical manifestations in patients treated with Nifurtimox and Benznidazole
15821262|NCT04274101|Diagnostic Test|Serologic response|Serologic response in patients treated with Nifurtimox and Benznidazole
15821263|NCT04274101|Diagnostic Test|Direct method|Direct method tests in patients treated with Nifurtimox and Benznidazole
15821264|NCT04274101|Behavioral|Adverse events|Adverse events in patients treated with Nifurtimox and Benznidazole
15821265|NCT04274088|Procedure|Cataract surgery|Phacoemulsification surgery
15821266|NCT04274075|Drug|GDC-9545 Tablet, Fasted: Treatment A|One dose of the GDC-9545 Phase 1 reference tablet formulation (three 10-mg tablets) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast.
15821267|NCT04274075|Drug|GDC-9545 Capsule, Fasted: Treatment B|One dose of the GDC-9545 Phase 3 capsule formulation (one 30-mg capsule) administered orally with approximately 240 mL room temperature water after at least an 8-hour fast.
15821268|NCT04274075|Drug|GDC-9545 Capsule, Fed: Treatment C|One dose of the GDC-9545 Phase 3 capsule formulation (one 30-mg capsule) administered orally with approximately 240 mL room temperature water within 30 minutes of eating a high-fat meal.
15821269|NCT04274062|Procedure|Integrated Nursing care of placenta previa|"Phase I :( preparation phase) Phase II: (Implementation phase) includes Preoperative care , intraoperative care and postoperative care by a nurse.
~Phase III: (Evaluation phase)"
15821270|NCT04274049|Genetic|NL003|Day 0: 8mg of NL003 (32 injections of 0.5ml of NL003) Day 14: 8mg of NL003 (32 injections of 0.5ml of NL003) Day 28: 8mg of NL003 (32 injections of 0.5ml of NL003)
15821271|NCT04274049|Other|Normal Saline|Day 0: 16ml of Normal Saline (32 injections ) Day 14: 16ml of Normal Saline (32 injections ) Day 28: 16ml of Normal Saline (32 injections )
15821272|NCT04274023|Drug|TSR-042|TSR-042 is an IgG4 humanized monoclonal antibody that binds with high affinity to PD-1, resulting in inhibition of binding to PD-L1 and PD-L2.
15821273|NCT04274010|Diagnostic Test|PillCamTM Crohn's capsule|Capsule endoscopy for small and large bowel to assess Crohn's disease activity.
15821274|NCT04274010|Diagnostic Test|Magnetic resonance enterography|MRI scan of small bowel to assess small bowel Crohn's disease activity.
15821275|NCT04274010|Procedure|Ileo-colonoscopy|Endoscopic procedure to assess Crohn's disease activity in colon and terminal ileum.
15821276|NCT04273997|Drug|Metronidazole 10% ointment|Metronidazole 10% ointment
15821277|NCT04273997|Drug|Placebo ointment|Placebo ointment
15821278|NCT04273984|Drug|Misoprostol|Tablets will be inserted digitally by an experienced gynecologist 3hours before IUD insertion with taking care not inserting the medication into the cervix.
15821279|NCT04273971|Other|Plyometric exercises|Plyometric exercises will be composed of vertical jumps, box jumps, half squat jumps, high straight jumps, bounding jumps, drop jumps and 10-m sprint.
15821280|NCT04273958|Device|Virtual reality helmet|During a painful procedure, the patient will watch a virtual world in a virtual reality helmet, while wearing a noise-canceling headset with soothing music.
15821281|NCT04273958|Device|Computer screen|During a painful procedure, the patient will watch the same virtual world, while wearing a noise-canceling headset with the same soothing music.
15821289|NCT04273906|Procedure|End-range mobilization|End-range mobilization performed in end-range of the tibiofemoral joints' flexion and extension
15821290|NCT04273906|Procedure|Placebo technique|Hands-on technique performed in end-range of the tibiofemoral joints' flexion and extension
15821291|NCT04273893|Radiation|SBRT with additional treatment planning dose optimization|Lung SBRT 50-60Gy in 5 fractions with standard of care planning and additional treatment planning dose optimization criteria to minimize decrease in lymphocyte count beyond dosimetric criteria from RTOG 0915/0813 SBRT trials.
15821292|NCT04273893|Radiation|SBRT with standard of care planning only|Lung SBRT 50-60Gy in 5 fractions with standard of care planning (no additional dose optimization beyond SOC)
15821293|NCT04273893|Diagnostic Test|Blood Draws|CBC w/ Diff and additional blood analysis for all participants in both groups. Blood draws will prior to treatment, end of treatment, 4 weeks after treatment, and 6 months after treatment.
15821294|NCT04273880|Drug|Methylphenidate|10mg of MPH taken an hour and a half before one of the testing sessions.
15821295|NCT04273880|Drug|Vitamin C|90 mg of Vitamin C taken an hour and a half before the other testing session
15821296|NCT04273867|Other|Chronic Hypersensitivity Pneumonitis Health Related Quality of Life Survey Instrument|This survey has been developed and revised from prior qualitative research with CHP patients and will be used to better evaluate disease status and quality of life with CHP.
15821298|NCT04273841|Dietary Supplement|Military Energy Gum|Caffeine (1, 3, 7-trimethylxanthine) is a central nervous system stimulant that is found naturally in some foods and beverages such as coffee and tea. For this study, caffeine will be administered in the form of gum pellets (Military Energy chewing gum). Each pellet contains 100 mg of caffeine.
15821299|NCT04273841|Dietary Supplement|Placebo Gum|Pellet form placebo gum
15821300|NCT04273828|Procedure|Lumbar decompressive surgery|Patients with lumbar degenerative diseases and symptoms of nerve compression (radiculopathy or neurogenic claudication) who will undergo surgical treatment for neural decompression (discectomy, foraminotomy or laminectomy).
15821301|NCT04273815|Drug|TQ-A3334|TQ-A3334 is a highly efficient and highly selective TLR-7 agonist. TLR-7 can induce the release of a series of pro-inflammatory cytokines, including IFN-α (interferon-α), IL-12 (Interleukin 12), TNF-α, and promote the maturation and antigen presentation of dendritic cells, play an antitumor effect.
15821302|NCT04273815|Drug|Anlotinib|Anlotinib is a multi-target receptor tyrosine kinase inhibitor.
15821303|NCT04273802|Drug|CPX-351 in cohort A|"Treatment by CPX-351 via intravenous infusion over 90 minutes.
~Induction treatment with CPX-351 100 Units/m²/D on days 1, 3 and 5.
~If response after this induction treatment, 4 courses of consolidation therapy with CPX-351 100 Units/m²/D on day 1.
~If no response after this induction treatment, a second induction course of CPX-351 100 Units/m²/D on days 1 and 3. If response is achieved after this salvage course, 3 courses of consolidation therapy with CPX-351 100 Units/m²/D on day1."
15821304|NCT04273802|Drug|CPX-351 in cohort B|"Treatment by CPX-351 via intravenous infusion over 90 minutes.
~This will be a dose-finding study : CPX-351 100 Units/m²/D on days 1, 3 and 5 or CPX-351 100 Units/m²/D on days 1 and 3 or CPX-351 60 Units/m²/D on days 1 and 3.
~In response after induction treatment, 4 monthly courses of consolidation therapy with CPX-351 at the same dose on day 1."
15821305|NCT04273789|Device|Far infrared reflecting sleepwear|100% microlyocell sleepwear (shorts + shirt) with a ceramic print that reflects far infrared light (FIR, 5.6-1000 µm) emitted by the human body. Since FIR active garments are not powered, but reflect recycle light energy emitted by the body of the wearer, they have irradiances between 0.1-5 mW/cm^2.
15821306|NCT04273789|Device|Placebo sleepwear|100% microlyocell sleepwear (shorts + shirt)
15821307|NCT04273776|Drug|Suvorexant 10 mg|10 mg of suvorexant
15821308|NCT04273776|Drug|Zolpidem|5 mg of zolpidem
15821309|NCT04273776|Drug|Placebos|Avicel
15821310|NCT04273763|Drug|Bromhexine Hydrochloride Tablets|Bromhexine Hydrochloride Tablets
15821311|NCT04273763|Drug|Arbidol Hydrochloride Granules|Standard treatment refers to the latest edition of Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection. Arbidol Hydrochloride Granules is recommended but not enforced to use.
15821312|NCT04273763|Drug|Recombinant Human Interferon α2b Spray|Standard treatment refers to the latest edition of Pneumonia Diagnosis and Treatment Scheme for Novel Coronavirus Infection.
15821313|NCT04273737|Drug|Amantadine Hydrochloride|6-week long daily regimen of amantadine, twice a day, while documenting perceived effects in a diary.
15821315|NCT04273698|Behavioral|Parent-infant psychotherapy|Brief psychoanalytic parent-infant psychotherapy
15821316|NCT04273685|Behavioral|Cognitive remediation training, social recovery therapy|10 weeks cognitive remediation training plus social recovery therapy. One hour face to face contact time with intervention therapist per week. At-home cognitive remediation training completion.
15821317|NCT04273685|Other|treatment as usual|10 weeks Treatment as usual non directive counselling One hour face to face contact time with intervention therapist per week.
15821318|NCT04273672|Diagnostic Test|Cognitive Battery|Participants will be asked to complete a series of cognitive testing (testing of concentration, memory, and other thinking abilities).
15821319|NCT04273672|Behavioral|Voice, Speech and Language Analysis|Participants will be asked to perform speaking and reading tasks, which will be recorded. Participants will be asked to complete a laptop-based test of language comprehension.
15821320|NCT04273672|Behavioral|Questionnaires and Clinical Assessments|Participants with Parkinson's disease will complete an examination of their symptoms and questionnaires assessing disease symptoms, mood and activities of daily living. Healthy controls participants will be asked to complete questionnaires on mood.
15821321|NCT04273672|Genetic|DNA Analysis|Participants will have their blood drawn for DNA analysis.
15821322|NCT04273659|Dietary Supplement|Pulses and cereals|Dietary intervention. Ingestion of pulses with cereals and gastrointestinal health.
15821323|NCT04273646|Biological|UC-MSCs|4 times of UC-MSCs(0.5*10E6 UC-MSCs/kg body weight intravenously at Day 1, Day 3, Day 5, Day 7).
15821324|NCT04273646|Drug|Placebo|4 times of cell-free stem cell suspension (saline containing 1% human albumin) intravenously at Day 1, Day 3, Day 5, Day 7).
15821325|NCT04273633|Device|Monopolar 448 kilohertz radiofrequency stimulation|448kilohertz capacitive resistive monopolar radiofrequency will be applied on the dominant shoulder
15821326|NCT04273633|Device|Placebo comparator|To simulate a 448kilohertz capacitive resistive monopolar radiofrequency application on the dominant shoulder
15821327|NCT04273620|Behavioral|Optokinetic stimulation and cueing-based reading therapy (OKS-READ)|"Each intervention session starts with an optokinetic stimulation (OKS) of at least 15 minutes duration. A pattern of squares, dots, triangles and stars will coherently and continuously move to the left on a computer screen in front of the patients. Patients are instructed to choose one stimulus and follow it with the eyes until it has reached the left side of the screen, then jump to the right edge of the screen and start again.
~The second part of each intervention session is the cueing-based reading therapy (READ), which will also last at least 15 minutes. The task of the patient is to read out loud words or a text presented on a paper in front of them. We will use exogenous (e.g., the therapist highlights words when they were omitted) and endogenous cues (verbal instructions which require intrinsic action by the patient) to facilitate attentional shifts to the left. The intensity of cueing will be matched to the actual severity of neglect (adaptive therapy)."
15821328|NCT04273620|Behavioral|General neuropsychological treatment|As a control treatment the patients will receive neuropsychological treatment without targeting visuospatial attention. Examples for components implemented are supporting conversations, diagnostic assessments (e.g. memory diagnostics) and training of memory and executive functions.
15821329|NCT04273607|Drug|Subcutaneous Heparin|The intervention group will receive prophylactic heparin instead of standard of care therapeutic intravenous heparin
15821330|NCT04273594|Device|FemBloc|Treatment with FemBloc for women who desire permanent birth control (female sterilization)
15821331|NCT04273581|Drug|placebo|100mg/d，qn，for 14 days.
15821332|NCT04273581|Drug|Thalidomide|100mg/d，qn，for 14 days.
15821333|NCT04273568|Other|Scapular PNF|Rhythmic initiation and repetitive stretching techniques in scapula anterior elevation-posterior depression and anterior depression-posterior elevation patterns were applied twice a week for 6 weeks.
15821334|NCT04273568|Other|Exercise program|An exercise program consisting of exercises used in the conservative treatment of shoulder impingement syndrome for both groups was applied twice a week for 6 weeks.
15821335|NCT04273555|Drug|[18F]-FDG|[18F]-FDG will be injected prior to PET/MRI imaging up to three times over the course of six months.
15821336|NCT04273542|Other|liquid biopsy|Blood sample collection during follow-up of the three cohorts of patients
15821337|NCT04273529|Drug|thalidomide|100mg，po，qn，for 14 days.
15821338|NCT04273529|Drug|placebo|100mg，po，qn，for 14 days.
15821339|NCT04273516|Drug|Rivaroxaban 2.5 Mg Oral Tablet|Tablet Rivaroxaban 2.5 mg 2 times daily add to standard treatment ASA 80 mg daily
15821340|NCT04273516|Drug|Rivaroxaban placebo tablets|Placebo tablets add to ASA 80 mg daily that is standard treatment
15821341|NCT04273503|Behavioral|Mentoring/educational session|12 mentoring/educational sessions focused on physical activity and healthy nutrition by Mayo Clinic experts.
15821342|NCT04273464|Procedure|Brava-group|Breast reconstruction by external tissue expansion and multiple fat transplantations(Brava group); Breast reconstruction with microsurgical DIEP-flap transfer.
15821343|NCT04273464|Procedure|DIEP-group|Microsurgical reconstruction by DIEPO method
15821344|NCT04273438|Device|Visual field testing using Oculus Rift and Humphrey Visual Field Perimeter|Glaucoma patients at Queen's University, Belfast, will be invited to undergo both Visual field testing using the Oculus Rift and the gold-standard Humphrey 24-2 (Carl Zeiss Meditec, Dublin, CA) at two visits, and evaluating consistency for detecting visual field impairments.
15821345|NCT04273438|Device|Visual Field Testing using HUmphrey 24-3 Perimeter|Glaucoma patients at Queen's University, Belfast, will be invited to undergo both Visual field testing using the Oculus Rift and the gold-standard Humphrey 24-2 (Carl Zeiss Meditec, Dublin, CA) at two visits, and evaluating consistency for detecting visual field impairments.
15821346|NCT04273412|Behavioral|moderate-intensity lifestyle intervention|standardized 12- week program and would be delivered in 4 sessions (2 individual, 2 telephonic). This lifestyle modification program is a combination of diet therapy (optimum calorie), increased daily physical activity and behavioral modification (self-monitoring, stimulus control, motivational interviewing)
15821347|NCT04273399|Other|High-impact exercise intervention|"Twelve-week high-impact exercise intervention
~Majority home based sessions, some supervised sessions
~Three exercise sessions per week
~Between 50 - 100 jumps per session
~Progressive jumping exercises to increase mechanical loading"
15821348|NCT04273399|Other|Acute response to high-impact exercise|"First session of twelve-week high-impact exercise session used to assess the acute physiological response to one session of high-impact exercise in both Crohn's disease and healthy controls
~One supervised session of high-impact exercise
~Bloods to assess acute inflammatory and bone turnover response post-exercise"
15821350|NCT04273373|Biological|Low Dose Albumin|20% albumin.5 g/kg at diagnosis and 0.5 g/kg till 5days
15821351|NCT04273373|Biological|Standard dose Albumin|20% albumin1.5 g/kg at diagnosis and 1 g/kg at 48 h (duration of infusion 24 hours).
15821352|NCT04273360|Other|Systematic use group|Patients in this group will be subjected to initial systematic PR, which will be re-evaluated every day every day between day 0 and day 14
15821353|NCT04273360|Other|Restrictive use group|Patients in this group will be subjected to PR only in case of severe agitation, defined by a RASS ≥ +3 on any given day between day 0 and day 14
15821354|NCT04273347|Other|standard of care for patient with brain trauma and spinal cord injury|neurological examination, examination of articulation, infectious status, respiratory status, inflammatory status,kinesitherapy
15821355|NCT04273334|Drug|68Ga-NEB|68Ga-NEB were injected into the patients before the PET/CT scans
15821356|NCT04273321|Drug|Methylprednisolone|Methylprednisolone 1mg/kg/day ivgtt for 7 days.
15821357|NCT04273308|Device|whole-body vibration training|The experimental group participated in a 12-week whole-body vibration training that was conducted 3 times per week, with 5-min continuous vibration at 12-Hz frequency and 3-mm amplitude each time. The control group were provided home DVDs on resistance exercise and manuals for preventing frailty
15821358|NCT04273295|Other|Abdominal massage|The patients lying in comfortable relaxed supine position and physiotherapist performed slow circular clockwise movements on the abdomen, throw tangential pushing, with digital pulp, slow and gradual pressure, with fingers inclination 45 degree. The pressure applied to the abdomen on each point for 1 min, beginning with the ascending colon, transverse colon, descending colon and sigmoid; this sequence was repeated approximately 15 min. The therapist teaches the parents this technique and asked them to apply at home 3 times / day for 15 min.
15821359|NCT04273282|Drug|Dexycu intracameral dexamethasone|To evaluate the safety and ocular efficacy of Dexycu.
15821360|NCT04273282|Drug|Prednisolone Acetate|To evaluate the safety and ocular efficacy, and patient acceptance of post cataract surgery drug treatment regimen that minimizes topical medications.
15821361|NCT04273269|Genetic|LYS-GM101|LYS-GM101 is an adeno-associated viral vector serotype rh.10 (AAVrh.10) carrying the human β-galactosidase gene, formulated as a suspension for injection
15821362|NCT04273256|Drug|Myo-inositol|patients who will be supplemented with 2 grams of Myo-inositol daily for 3 months prior to their in-vitro fertilization cycle
15821363|NCT04273243|Genetic|AT-GTX-501|No study drug is administered in this study. Subjects who received AT-GTX-501 in a previous trial will be evaluated in this trial for long-term safety and efficacy.
15821364|NCT04273230|Other|Microalbuminuria detection|Detection of microalbumin in urine
15821365|NCT04273217|Drug|AV-1|Single ascending dose, administered by IV infusion
15821366|NCT04273217|Drug|Placebo|0.9% sterile saline. Administered by IV infusion
15821367|NCT04273204|Diagnostic Test|one leg standing test, gross motor function measurement, pedobarographic measurement|OLST:During the OLST,the participants were asked to shoes off,place both hands on their hips and look at a point on the wall at eye level.A recording stopwatch was used to assess their standing duration on one leg while keeping the other leg in 90 degrees of knee flexion.The test was stopped when the contralateral foot touched the ground or when the participant broke 90 degrees of knee flexion.The OLST was repeated three times for each leg.GMFM:To assess standing and walking,running and jumping functions of the UCP group,the D and E dimensions of GMFM were utilized by a certificated physiotherapist.Each item was tested by three trials and the best trial was used.Pedobarography:The participants' plantar pressure was analyzed using pedobarography.For each participant, the pedobarography was calibrated before the assessment.During the pedobarographic analysis, the participants walked barefoot in 90 BPM cadence. Three steps were analyzed for each side.
15821368|NCT04273191|Drug|Brexanolone|Brexanolone will be initiated and administered per the USPI and the associated REMS.
15821369|NCT04273178|Drug|Escalating prophylaxis|For all patients without documented proven or probable invasive fungal disease (IFD), patients will receive fluconazole during the treatment in the laminar air flow units (LAF). After discharged from LAF units, patients will receive anti-mold prophylaxis in case of haplo-identical or HLA-matched unrelated donor transplantation to d+100 without active acute GVHD (aGVHD). In case of active aGVHD, the prophylaxis treatment will be extended until recovery of aGVHD and tapering of immunosuppression. In case of HLA-matched sibling donor, fluconazole will be continued to d+100 and anti-mold prophylaxis will be given in case of active aGVHD.
15821370|NCT04273165|Drug|Etravirine Tablets|Daily etravirine BID with 100 or 200 tablets for 4 months
15821371|NCT04273152|Diagnostic Test|advanced glycation endproducts reader|advanced glycation endproducts reader
15821372|NCT04273139|Drug|IBRUTINIB|Ibrutinib Cycle 1-24 will be administered at a predetermined dose, once daily for 28 days
15821373|NCT04273139|Drug|Venetoclax|Venetoclax Cycle 2-24 will be administered daily for 28 days. Predetermined dosage ramp up schedule during cycle 2.
15821374|NCT04273126|Behavioral|Adapted Family Resilience Intervention|The program consists of approximately 8-10 modules lasting approximately one hour. Sessions focus on psychoeducation and key resilience skills.
15821375|NCT04273113|Other|Difficulties in Emotional Regulation Scale, Five Facet Mindfulness Questionnaire, Becks Depression and Becks Anxiety|Patients asked to complete these 4 questionnaires pre, during and post biofeedback training
15821376|NCT04273113|Behavioral|HRV Biofeedback (Healing Rhythms)|Sensors placed on fingers to capture heart rate and skin temperature
15821377|NCT04273100|Combination Product|PD-1 mAb combined with TACE and lenvatinib|the combination of immunotherapy (PD-1 monoclonal antibody), local therapy (TACE) and anti-angiogenic therapy (lenvatinib)
15821378|NCT04273087|Other|Observation|Clinical signs and symptoms
15821379|NCT04273074|Radiation|sonographic assessment|preoperative sonographic assessment to airway
15821380|NCT04273061|Drug|Atezolizumab|1200 mg by intravenous infusion every 3 weeks as tolerated
15821381|NCT04273048|Other|Diet Intervention - Group 1|They will be provided with a Mediterranean diet plan.
15821382|NCT04273048|Other|Exercise Intervention - Group 1|They will be provided with an exercise plan to follow.
15821383|NCT04273035|Drug|Midazolam oral solution|Oral Buccolam
15821384|NCT04273035|Device|IPAD|Playing any game, film, clip or puzzle on a tablet till after induction of anesthesia
15821385|NCT04273022|Other|Exercise|A single bout of standardized, moderate exercise
15821386|NCT04273009|Device|Renew VS PTNS|These will be prescribed and applied as described above.
15821387|NCT04272996|Procedure|Craniotomy only|evacuation of SDH
15821388|NCT04272996|Procedure|Craniotomy + Endovascular embolization of the middle meningeal vessels|evacuation of SDH + Embolization of middle meningeal vessels using standard techniques.
15821389|NCT04272970|Diagnostic Test|Validation of a new gene / protein variant implicated in familial CT|Realize a blood sample to perform functional studies of circulating blood platelets and hematopoietic progenitor cells, in order to prove the pathogenicity of variants of new genes potentially involved in constitutional thrombocytopenia.
15821390|NCT04272957|Drug|HMPL-306|HMPL-306 administered continuously as a single agent starting at 25 mg orally every day in a 28-day cycle and dose escalation is planned up to 200mg. Subjects may continue treatment with HMPL-306 until disease progression, development of other unacceptable toxicity or hematopoietic stem cell transplant.
15821888|NCT04268745|Behavioral|Balance training|Progressive balance training within virtual environments
15821391|NCT04272944|Drug|MSB2311 Injection|An intravenous infusion with concentration from 3 mg/kg to 20 mg/kg every 3 weeks (Q3W)or every 2 weeks(Q2W).
15821392|NCT04272931|Procedure|Portal and Hepatic Vein Embolization|Procedure/Surgery: Combined portal vein embolization and hepatic vein embolization (PVE/HVE) • All techniques of PVE allowed (ipsi-lateral, contra-lateral, trans-splenic, all embolization agents except for ethanol alone) • All modifications of HVE allowed (venous occlusion umbrellas; trans-jugular, trans-hepatic, no use of vein glue to avoid lung embolization; staged approach allowed, but first PVE, then HVE and within 48 hours)
15821393|NCT04272918|Behavioral|Caregiver Support Model|Examine the effectiveness of the Caregiver Support Model (CSM) on improving caregivers' well-being.
15821394|NCT04272918|Behavioral|Psycho-education Program|Examine the effectiveness of the Psycho-education Program (PP-E) on capacity building, empowerment, and improving well-being.
15821395|NCT04272905|Other|Non-interventional study|The participants will be asked to complete a questionnaire on their knowledge of, and attitudes towards the recording of patient care by patients or relatives/friends in the maternity unit. An investigator will be immediately available to facilitate completion of the survey and assist with understanding of the questions. The data recorded will be a mixture of nominal data (selections from a number of options using a tickbox) or ordinal (as above, but graded e.g. yes / yes with qualifiers / no). Free text will be coded and presented as nominal data or presented verbatim to illustrate points that arise.
15821396|NCT04272892|Behavioral|Digital cognitive behavioural therapy for insomnia|6 weeks of cognitive behavioural therapy for insomnia (Sleepio) delivered online
15821397|NCT04272892|Behavioral|Sleep hygiene information|A leaflet detailing advice to improve sleep through changes in sleep hygiene
15821398|NCT04272879|Other|Observational Group|Those requiring NIV following an acute exacerbation of COPD
15821399|NCT04272866|Other|Clinpro sealant|Resin based sealant
15821400|NCT04272866|Other|Embrace wetbond sealant|Moisture tolerant hydrophilic resin based sealant
15821401|NCT04272866|Other|Triage sealant|Glass ionomer sealant
15821402|NCT04272853|Other|Interview|Compilation of the interview concerning: demographic data, sports practice, habits on sleep, sexual habits, perception of the relationship between sexual habits and sleep, perception of the relationship between sexual habits and sports practice.
15821403|NCT04272840|Behavioral|Low Glycemic Index Education|Educational materials layering Glycemic Index education onto Canada's Food Guide and Diabetes Canada recommendations.
15821404|NCT04272827|Procedure|Liposuction|"Liposuction treatment will be performed according to the study protocol using the wet technique depending on the amount of fat to be removed, if necessary in several sessions."
15821405|NCT04272814|Other|Compression therapy|Compression application
15821406|NCT04272814|Diagnostic Test|initial clinical assessment|Initial clinical assessment (includes history, vascular assessment, limb examination and wound assessment where necessary)
15821407|NCT04272801|Drug|tamoxifen, letrozole, anastrozole, or exemestane|choice and dose of neoadjuvant endocrine therapy at the discretion of the treating medical oncologist
15821408|NCT04272801|Behavioral|Patient reported outcomes|"Questionnaires inquire:
~how cancer affects daily living
~beliefs about medicines and sensitivity to medicine
~symptoms
~adherence to endocrine therapy
~general health and well being
~depression and anxiety
~preference regarding radiation therapy"
15821409|NCT04272788|Drug|Infliximab|The CD patients at initial active stage without treatment of glucocorticoids, immunosuppressants and biological agents are included in the study when the decision to treat with Infliximab is already made. This study is observational, and all treatment and clinical follow-up are according to national guidelines.
15821410|NCT04272775|Drug|Ixazomib|Ixazomib capsules.
15821411|NCT04272775|Drug|Lenalidomide|Lenalidomide capsules.
15821412|NCT04272775|Drug|Dexamethasone|Dexamethasone tablets.
15821413|NCT04272762|Procedure|Cryoablation|Pulmonary vein isolation with cryoablation
15821414|NCT04272762|Procedure|Placebo|Placebo procedure
15821415|NCT04272749|Behavioral|Assess opinons on the milk beverages|Questionnaires and consumption behaviors of dairy and non-dairy milks, including whole, 2% fat, 1% fat, skim, unsweetened almond, sweetened almond, unsweetened coconut, sweetened coconut, unsweetened soy, sweetened soy, unsweetened rice, and sweetened rice.....
15821416|NCT04272736|Dietary Supplement|Low calorie protein substitute|The evaluated dietary supplement is a lower calorie amino acid based liquid protein substitute designed for patients with PKU.
15821417|NCT04272684|Other|Driving Assessment|Participants will undergo a driving assessment approximately two months after returning home from hospital
15821418|NCT04272671|Other|Educational Intervention|The intervention has the following components: 1) alerts given to providers to identify patients taking opioids or benzodiazepines (BZD) and therefore at risk for falls; 2) educational materials to inform providers on best practices for de-prescribing opioids and BZDs in patients at risk; and 3) recommendations on de-prescribing provided by a consultant pharmacist. Impact of the intervention will be evaluated using pre-post surveys evaluating changes in providers' knowledge, confidence, and skills as well as information from the EHR to evaluate impact of the intervention on de-prescribing opioids and BZDs.
15821419|NCT04272658|Diagnostic Test|value of 4D body-to-whole dynamic acquisition in FDG|"differentiate pseudo-progression / progression during the first therapeutic assessment by FDG PET / CT (PET1) using data from the 4D whole-body dynamic acquisition, without having to re-evaluate closely. during a PET1 'this unconfirmed progression after 2 new treatment cures of ICI"
15821420|NCT04272645|Drug|Abemaciclib 200 MG|200 MG orally BID Days 1-21
15821421|NCT04272645|Drug|Atezolizumab 1200 MG in 20 ML Injection|1200 mg IV on Day 1 of 21-day cycle
15821422|NCT04272645|Drug|Abemaciclib 150 MG|150 MG orally BID Days 1-21
15821423|NCT04272632|Drug|4 ml/kg group|4 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia.
15821424|NCT04272632|Drug|8 ml/kg group|8 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia.
15821425|NCT04272632|Drug|12 ml/kg group|12 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given immediately after spinal anesthesia.
15821486|NCT04272177|Other|Shared decision making with the used of patient decision aids|PDA is used to explain choices of reversal drugs using SDM approach during consultation. The patients and medical staff explore the preferences with PDA and make decision together.
15821426|NCT04272619|Behavioral|LIVE-R Life Education|A health educator will present participants with a 30-minute PowerPoint presentation containing educational information about liver cancer risk, screening, prevention, symptoms, and treatments, as well as introduce the concept of neighborhood health (e.g., rates of liver cancer and related risk factors in a census tract and how that might influence individual cancer risk).
15821427|NCT04272606|Drug|Tranexamic Acid|Antifibrinolytic Agent
15821428|NCT04272606|Drug|Saline Solution|Placebo
15821429|NCT04272606|Diagnostic Test|Visual Acuity Exam|Supplemented into standard of care daily neurological exam on day of surgery and day after
15821430|NCT04272593|Device|EMG-Pattern Recognition Controller|Using an electromyographic (EMG)-based pattern recognition controller to move an upper limb prosthetic device.
15821431|NCT04272580|Drug|Control group|No preload was given before spinal anesthesia.
15821432|NCT04272580|Drug|4 ml/kg group.|4 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given before spinal anesthesia.
15821433|NCT04272580|Drug|8 ml/kg group.|8 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given before spinal anesthesia.
15821434|NCT04272580|Drug|12 ml/kg group.|12 ml/kg compound sodium chloride (0.85% NaCl, 0.03% KCl, and 0.033% CaCl2) was given before spinal anesthesia.
15821435|NCT04272567|Drug|Norepinephrine|Simultaneous with subarachnoid block, a bolus of 6μg norepinephrine was given followed by different infusion dose of norepinephrine.
15821436|NCT04272567|Drug|Normal saline|Simultaneous with subarachnoid block, a bolus of 1ml normal saline was given followed by normal saline infusion
15821437|NCT04272541|Behavioral|Psychoeducation program|Intervention program consisted of psychopharmacology + psychoeducation. This will be executed during 3 months, distribuited in several sessions.
15821438|NCT04272541|Drug|Psychopharmacology intervention|Intervention program consisted of psychopharmacology. This will be executed during 3 months.
15821439|NCT04272528|Other|uniform care|The leader develops training plan and trains nurses, who provide uniform care and education to patients according to the training.
15821440|NCT04272528|Other|conventional care|Nurses carry out the routine care procedures.
15821441|NCT04272515|Other|blood sampling|collection of blood sample for preparation of DNA
15821442|NCT04272515|Other|skin biopsy sampling|preparation of primary cultures of dermal fibroblasts from skin biopsy sample
15821443|NCT04272515|Other|explanted liver of BA patients sampling|cryoconservation of liver tissue for molecular analyses
15821444|NCT04272502|Drug|CKD-348 F1, CKD-348 F2, CKD-828, D326, D337|Each arm has a different order for taking IP
15821445|NCT04272489|Device|EMG-Pattern Recognition Controller|Using an electromyographic (EMG)-based pattern recognition controller to move an upper limb prosthetic device in a home trial.
15821446|NCT04272476|Other|acupuncture and moxibustion|
15821447|NCT04272476|Drug|Fluoxetine|
15821448|NCT04272463|Other|No intervention|Patients currently in treatment with benralizumab as per approved indication and clinical practice
15821450|NCT04272437|Drug|Concentrated herbal extract granules TRA|Concentrated herbal extract granules Subjects in the TRA group orally ingested one package of granules (5 g/package) two times daily with warm water after lunch and dinner for 6 consecutive weeks.
15821451|NCT04272437|Drug|Placebo|Subjects in the placebo group orally ingested one package of granules (5 g/package) two times daily with warm water after lunch and dinner for 6 consecutive weeks.
15821452|NCT04272424|Procedure|laparoscopic mesh fixation|laparoscopic mesh fixation by non fixation,tacker and histoacryl
15821453|NCT04272411|Device|Sham SCS stimulation|Sham SCS stimulation via implanted neuromodulation device for 45 min during the steady state of a hyperinsulinemic euglycemic clamp.
15821454|NCT04272411|Device|Tonic SCS stimulation|Tonic SCS stimulation via implanted neuromodulation device for 45 min during the steady state of a hyperinsulinemic euglycemic clamp.
15821455|NCT04272411|Device|Burst SCS Stimulation|Burst SCS stimulation via implanted neuromodulation device for 45 min during the steady state of a hyperinsulinemic euglycemic clamp.
15821456|NCT04272398|Other|dynamic elastomeric fabric orthoses|Wore dynamic elastomeric fabric orthoses with a focus on the lower body and pelvis in addition to the physiotherapy and rehabilitation sessions. The frequency of the use of the orthosis was planned to extend through the week and they had the orthosis during their active hours during the day about 8 hours a day.
15821457|NCT04272372|Drug|Ketoprofen|PO and local therapy
15821458|NCT04272359|Drug|Sulfa-zero: possible benefits of the treatment of new generation hypoglycaemic drugs compared to sulphonylureas|"Substitution of sulfonylureas with other classes of new hypoglycaemic drugs. In every group, it will be evaluated:
~efficacy in terms of glycometabolic compensation (glycemia, HbA1c, lipid profile);
~effects on BMI, blood pressure monitoring and hypoglycemic risk;
~changes in renal function and microalbuminuria;
~tolerability and side effects of the new therapeutic regimes;
~therapeutic adherence;
~post-prandial glycemic excursion, determined by a 6-point glycemic diary (pre- and 2h post-prandial glucose values) to be performed at home in the week before the scheduled follow-up visit;
~effects on chronic complications of diabetes and cardiovascular safety."
15821459|NCT04272346|Behavioral|Writing for others|Participants will receive general instructions for completing the writing sessions and will be asked to write for at least 20 minutes per session. Topics covered in each session will vary and are related to common cancer-related themes (e.g., receiving a diagnosis, undergoing treatment, etc.). Participants will be instructed not to worry about grammar, spelling, or sentence structure and reminded that their responses will remain anonymous. Writing sessions (four in total) will be spaced 1 week apart, and participants will be instructed to write about their experience for the benefit of a newly-diagnosed cancer patient.
15821520|NCT04271930|Behavioral|Mindfulness Awareness Practices for Insomnia|MAP-I is a curriculum-based intervention that incorporates practice prior to bed, use of practice in the bed during night-time awakenings, and daily body scan.
15822033|NCT04267796|Other|Aerobic Exercise|Complete aerobic training
15821460|NCT04272346|Behavioral|Processing + writing for others|Participants will receive general instructions for completing the writing sessions and will be asked to write for at least 20 minutes per session. Topics covered in each session will vary and are related to common cancer-related themes (e.g., receiving a diagnosis, undergoing treatment, etc.). Participants will be instructed not to worry about grammar, spelling, or sentence structure and reminded that their responses will remain anonymous. Writing sessions (four in total) will be spaced 1 week apart. For the first three writing sessions, participants will write their deepest thoughts and feelings regarding cancer diagnosis and treatment. In the final writing session, participants will be instructed to write about their experience for the benefit of a newly-diagnosed cancer patient.
15821461|NCT04272346|Behavioral|Facts-only writing|Participants will receive general instructions for completing the writing sessions and will be asked to write for at least 20 minutes per session. Topics covered in each session will vary and are related to common cancer-related themes (e.g., receiving a diagnosis, undergoing treatment, etc.). Participants will be instructed not to worry about grammar, spelling, or sentence structure and reminded that their responses will remain anonymous. Writing sessions (four in total) will be spaced 1 week apart. Unlike the previous conditions, participants will not be instructed to write about their experience for the benefit of a newly-diagnosed cancer patient.
15821462|NCT04272333|Drug|Motolimod|Intratumoral microdose injection by the CIVO device.
15821463|NCT04272333|Biological|Nivolumab|Intratumoral microdose injection by the CIVO device.
15821464|NCT04272333|Combination Product|Motolimod + Nivolumab|Intratumoral microdose injection by the CIVO device.
15821465|NCT04272320|Drug|Bupivacaine Hydrochloride|Ultrasound-guided Transversalis Fascia Plane Block with 0.5 ml/kg %0.25 bupivacaine
15821466|NCT04272307|Biological|Blood samples|"At inclusion, at day 5, day 42 and at 3 months, one 2 ml EDTA blood tube will be collected for metabolomics.
~Polar metabolites, lipids, free fatty acids and bile acids will be identified and quantitated using ultra high-performance liquid chromatography/tandem accurate mass spectrometry method.
~At inclusion, one 2 ml EDTA tube will be stored as a DNA collection."
15821467|NCT04272307|Procedure|Stool samples|"One stool sample will be taken at baseline, day 5, day 42 and at 3 months and frozen at -80°C and divided in 2 aliquots.
~One stool aliquot will be used for metabolomics. Polar metabolites, lipids, free fatty acids and bile acids will be identified and quantitated using ultra high-performance liquid chromatography/tandem accurate mass spectrometry method. The other one will be used for microbiota analysis. Samples will be sent to the McGill University (Prof. SALEH's lab) for extraction and then, Génome Québec Innovation Centre (McGill University, Montréal, Canada) for sequencing of the V4 region of the 16S rRNA gene on Illumina MiSeq in paired-end mode."
15821468|NCT04272307|Procedure|Colorectal biopsies|During routine flexible sigmoidoscopy, 6 biopsies will be collected with a 5 mm biopsy forceps at baseline and at 3 months. Biopsies will be placed into a sterile vial containing RNAlater (Qiagen, Hilden, Germany) and stored at -80°C. Two biopsies will be used for mucosal microbiome analysis in the same way as the stool sample. Four biopsies will be used for RNAseq. Samples will be shipped to Prof. SALEH's lab in Montréal for nucleic acid extraction. The McGill University and Génome Québec Innovation Centre (McGill University, Montréal, Canada) will provide library preparation and next generation sequencing. The average number of uniquely mapped reads per sequencing run will be 30 million reads per sample.
15821469|NCT04272294|Device|Optical Spectroscopy|Using oral spectroscopy device to characterize treatment response in tumors
15821470|NCT04272281|Procedure|medical shared decision|The experimental group will use the share decision making tool during consultation to adapt antibiotherapy
15821471|NCT04272281|Procedure|Standard medical care|control group will act as usual in their practice.
15821472|NCT04272268|Device|Nasal High flow Oxygen|If the patient is successfully extubated within 4 hours following surgery and meets the post surgery inclusion/exclusion criteria, Nasal high flow oxygen will be administered continuously using a humidifier machine for 5 days. Breathing circuits and nasal cannulae will be connected to the machine to deliver oxygen at 20L/min to the patient.
15821473|NCT04272255|Drug|scopolamine HBr|Nasal Gel
15821474|NCT04272255|Drug|Transdermal Scopolamine|Patch
15821475|NCT04272242|Drug|Dolutegravir (DTG)|Administered orally
15821476|NCT04272242|Drug|Isoniazid (INH)|Administered orally
15821477|NCT04272242|Drug|Rifapentine (RPT)|Administered orally
15821478|NCT04272242|Drug|Antiretroviral Therapy (ART)|Participants will remain on DTG-based ARV treatment with 2 NRTIs (excluding TAF) during the study. NRTIs will not be provided by the study. Arm 1 participants will take non-study supply of DTG for morning doses, and will take study-supplied DTG for evening doses. For Arm 2 participants, DTG will be from non-study ARV supply.
15821479|NCT04272242|Dietary Supplement|Pyridoxine (Vitamin B6)|All participants must receive 25 or 50 mg of pyridoxine (vitamin B6) with each dose of INH, based on the current local, national, or international dosing guidelines. Pyridoxine is not provided by the study.
15821480|NCT04272229|Diagnostic Test|Cognition|Cognition tests will be performed with questionnaires, which will be applied to the main investigator. Stroop Color test, digit symbol substitution test, Addenbrooke's cognitive examination 3, mini-mental state examination, Montreal Cognitive Assessment, Trail Making Test A e B and Reaction time test will be performed to check the cognition in all volunteers.
15821481|NCT04272229|Diagnostic Test|Sympathetic Nervous System|The sympathetic activation will be evaluated by heart rate variability. Volunteers will have their hear rate recorded by a frequencymeter and the R-R interval will be analyzed to ch check the central nervous system activation during all cognitive tests.
15821482|NCT04272229|Diagnostic Test|Concentratio and Attention|Concentration and attention measures will be recorded with the MindWave headset during all cognitive tests. The EEG will be recorded with the MindWave and then alfa wave will be analized to check the attention and concentration levels.
15821483|NCT04272216|Other|Treatment with HydroPearl via radial access|This is an observational study collecting data on patients who are already being treated with HydroPearl on-label per standard of care.
15821484|NCT04272203|Drug|ABBV-184|Intravenous (IV) infusion
15821485|NCT04272190|Other|clinical routine treatments|The cohort stratified by four factors: preoperative treatment (not received, neoadjuvant chemotherapy, preoperative radiotherapy); surgical approach (laparoscopic, abdominal, vaginal, robotic); hysterectomy types (type A, type B, type C1, type C2), primary treatment (Radical hysterectomy + pelvic lymph node dissectionp; radiochemotherapy)
15821487|NCT04272164|Other|technical taekwando training|Light jogging followed by star jump, Different running styles (forward, backward and sideways), Stretching exercises (Upper and lower Limb), Pushups and sit ups, Punches (single, double, triple, nonstop punches including speed and power, punches with forward and backward stepping), Kicks (rising kick, front kick, middle kick, drop kick ( in +out+center), Stances (walk stance, punching stance, front deep stance, kicking stance), Blockings (solar block, upper block and lower block), Self -defense (neck gripping, hand gripping, locking), Sand bag drills, Balance training 10 repeatitions of 1 set each, 3 days a week for 8 weeks
15821488|NCT04272164|Other|weighted rope jump training|Basic bounce step with both feet 2. Bell jump with both feet 3. Skier's jump 4. Right foot skipping 5. Left foot skipping, 6. Alternate foot step 7. Boxer shuffle 8. Side straddle 9. Scissors 10. Bonus jump with both feet After the preparatory weighted rope jump training (WRJT) for 1 week, subjects in experimental group followed jumping training by repetition method 3 days in a week for 8 weeks in addition to the routine taekwondo training program. 3 sets per week with 30 seconds training duration and 30 seconds rest duration. with progressive increase in the intensity and no. of sets.
15821489|NCT04272151|Biological|BCMA CAR-T cells|A single infusion of BCMA CAR-T cells will be administered intravenously.
15821490|NCT04272138|Behavioral|Calm Meditation|"The intervention will run for 4-weeks. Participants will complete the 30 day, How to Meditate meditation series that provides daily 10-minute meditations. Throughout the intervention, participants will be sent reminder emails via REDCap to participate in their assigned practice sessions participants and will complete online weekly participation logs via REDCap. Additionally, they will answer one, multiple-choice ecological momentary assessment question, randomly, 3x per day via test message assessing how one currently feels. Participants will complete baseline and post-intervention measures of the Perceived Stress Scale, Hospital Anxiety and Depression Scale, Mindfulness Attention Awareness Scale, International Physical Activity Questionnaire, Salzberg Stress Eating Scale, Brief Cope, and Brief Resilience Scale. Following these measures, participants will be asked to complete a satisfaction questionnaire (week 5) and have the opportunity to volunteer for a short phone interview."
15821491|NCT04272138|Behavioral|Educational Podcast Control|The intervention will run for 4-weeks. Control group participants will listen to daily 10-minute health education podcasts. Throughout the intervention, participants will be sent reminder emails via REDCap to participate in their assigned practice sessions and participants will complete online weekly participation logs via REDCap. Additionally, they will answer one, multiple-choice EMA (ecological momentary assessment) question, randomly, 3x per day via test message assessing how one currently feels. Participants will complete baseline and post-intervention measures of the Perceived Stress Scale, Hospital Anxiety and Depression Scale, Mindfulness Attention Awareness Scale, International Physical Activity Questionnaire, Salzberg Stress Eating Scale, Brief Cope, and Brief Resilience Scale. Following these measures, participants will be asked to complete a satisfaction questionnaire (week 5) and have the opportunity to volunteer for a short phone interview.
15821492|NCT04272125|Biological|CD123 CAR-T cells|A single infusion of CD123-CAR-T cells will be administered intravenously
15821493|NCT04272112|Combination Product|IPS e.max CAD, Ivoclar Vivadent|Type: monolithic lithium-disilicate glass ceramic
15821494|NCT04272112|Combination Product|BruxZir, Glidewell|Type: high translucent zirconia
15821495|NCT04272112|Combination Product|BruxZir*, Glidewell|Type: high translucent zirconia with a mini-veneer of porcelain
15821496|NCT04272099|Other|Administration of standardized questionnaires|Administration of questionnaires assessing subjective socioeconomic status (SES), health literacy, perceived health, health related quality of life, self-esteem and diabetes self-efficacy
15821497|NCT04272099|Device|Physical activity tracker|PG1 will be asked to wear a physical activity tracker for one week to monitor activity patterns including walking distance, calorie expenditure, sedentary time and sleep.
15821498|NCT04272099|Other|Dietary log|PG1 (or PG2 as proxies when appropriate) will report to a study coordinator via phone a full dietary log of PG1 once per week on rotating days of the week for three weeks.
15821499|NCT04272086|Drug|Bupivacaine|0.25%
15821500|NCT04272086|Drug|Bupivacaine liposome|10mL
15821501|NCT04272086|Drug|normal saline|10ml
15821502|NCT04272073|Other|High-Protein Mediterranean Diet|As in arm/group descriptions
15821503|NCT04272073|Other|Resistance Exercise|As in arm/group descriptions
15821504|NCT04272073|Other|Standard Dietary Advice|As in arm/group descriptions
15821505|NCT04272073|Other|Standard Cardiac Rehabilitation Exercise|As in arm/group descriptions
15821506|NCT04272060|Diagnostic Test|CT angiography|Diagnostic CT angiography
15821507|NCT04272060|Diagnostic Test|Invasive coronary angiography|Diagnostic invasive coronary angiography
15821508|NCT04272047|Other|Knee Control+ program|15-20 minute training program to be performed at all team training sessions during the season.
15821509|NCT04272047|Other|Adductor strengthening program|Adductor strengthening program to be performed 2-3 times per week, one set per side, during the pre-season, and 1 time per week, one set per side during the in-season.
15821510|NCT04272047|Other|Knee Control program|15-20 minute training program to be performed as per the team's usual routines (no intervention from the researchers).
15821511|NCT04272034|Drug|INCB099318|INCB099318 administered orally in 20 mg or 100 mg tablets once daily or twice daily on each day of each 28-day cycle.
15821512|NCT04272021|Drug|Methylphenidate|standard therapy for ADHD
15821515|NCT04271969|Device|SmartVest Airway Clearance System|Pulmonary airway clearance of retained mucus via high frequency chest wall oscillation (SmartVest)
15821516|NCT04271956|Biological|Tislelizumab|Cycle (q21d): Day 1: Tislelizumab i.v. 200 mg
15821517|NCT04271956|Drug|Zanubrutinib|Cycle (q21d): Zanubrutinib p.o. 160 mg twice a day
15821518|NCT04271943|Behavioral|Computer Based Exercises|For 8 weeks 3 days a week for 45 minutes See-ME Virtual Rehabilitation system with the physical therapist will perform cognitive and physical activity exercises
15821519|NCT04271943|Dietary Supplement|Aerobic Exercises|For 8 weeks 3 days a week exercise bike with 5 min warm-up 35 min constant speed exercise 5 min cooling, a total of 45 min prescribed by the physiotherapist to the maximum heart rate will do aerobic exercise work. Cardiac values will also be monitored throughout the session
15821521|NCT04271930|Behavioral|Sleep Health Information|A video SHE seminar will serve as active comparator for nonspecific treatment elements that pose rival explanations for the effectiveness of MAP-I.
15821522|NCT04271917|Drug|cannabidiol|Use of cannabidiol as an alternative to standard of care treatment of acute pain.
15821523|NCT04271917|Drug|placebo|Inactive placebo oil to imitate CBD oil
15821524|NCT04271917|Drug|acetaminophen 500mg and ibuprofen 200mg combo|standard of care
15821525|NCT04271904|Other|Anti-inflammatory Diet|"Participants will be given a list of foods that they are allowed on the anti-inflammatory diet, and a list of foods to avoid so that they can make informed substitutions to the meals and ingredients that they are given. The study participants will be given a one-week meal plan with accompanying recipes. Occasional cheat foods are built into the anti-inflammatory diet (e.g. two bottles of beer per week)"
15821526|NCT04271904|Other|Placebo Diet|"The dietitian will assist in developing a diet that is isocaloric to the anti-inflammatory diet and healthy (for the sake of the participants' well-being, and to blind participants), while allowing many foods that are (counterintuitively) pro-inflammatory (e.g. whole wheat bread, white beans, oats, soy, eggplant, raspberries, pumpkin seeds, popcorn, etc). Occasional cheat foods are built into the placebo diet but with more pro-inflammatory options (e.g. two glasses of wine per week)."
15821527|NCT04271891|Device|WBPC|The duration will be 30 minutes a time, and the frequency will be 5 days a week, and the treating period will be 3 weeks.
15821528|NCT04271891|Device|Without WBPC|Not treat with WBPC
15821529|NCT04271878|Other|RespirAct™ system (Thornhill Research Inc., Toronto, Canada)|"HUTT with Normal Breathing in Room Air (No gas interventions will be applied)
~HUTT with Normal Breathing and ETCO2 clamped at baseline levels
~HUTT with Normal Breathing and Mild Hypercapnia (the ETCO2 will be clamped at 45mmHg )
~HUTT with Normal Breathing and High Hypercapnia (the ETCO2 will be clamped at 55mmHg)
~HUTT with Fast, Deep Breathing and resultant Hypocapnia Participant will be coached to breath around 15 breath per min.No gas interventions will be applied
~HUTT with Fast, Deep Breathing and ETCO2 clamped at baseline levels. Participant will be coached to breath around 15 breath per min, with ETCO2 clamped to baseline levels."
15821530|NCT04271865|Other|Nutritional Education|Provision of weekly awareness and educational sessions for 6 months. Sessions were conducted at the community based associations within the cases respective villages. Cases were subjected to 24 sessions for improving the patients' own nutrition situation through nutritional education about food rich in iron and counselling. The sessions focused on basic knowledge on iron deficiency anaemia, the most common presenting symptoms, iron rich dietary sources, factors that enhance and inhibit iron absorption, effects of anaemia on health and how to prevent it, Role of dates fruit in preventing and treating anaemia. Th e sessions also focused on the provision of a diverse range of local iron rich food. Special focus was on increasing patients' awareness for self-management of their status
15821531|NCT04271865|Other|model nutrition kitchen|Implementing model nutrition kitchen; once every month for six months with six sessions for each village (6 sessions/village) with cooking sessions was done to promote eating healthy and provide innovative ideas for feeding anaemic cases. 117 patients were reached by the nutritional kitchen activities with 6 sessions until the end of the project. Special focus was done on skills like sharing cooking, meal planning, and label reading that help support healthy eating patterns. Suggesting ways that individuals can model healthy eating behaviors for friends and family members that is based on Dates fruit was encouraged.
15821532|NCT04271865|Other|recipe book|3) Development of recipe book that is based on the local food in the market to increase the number of nutritionally balanced meals and increase the frequency of iron-rich foods per day and improve current and risky nutritional habits
15821533|NCT04271865|Other|Provision of Dates|"Dates fruit intake for all the anaemic patients was provided for 16 weeks (four months):
~• Diagnosed anemic patients were given five to seven pieces of Dates (dependent on its weight) on daily basis for 16 weeks (each date fruits is about 10 -20 gm). Dates was taken as breakfast on daily base.
~The Dates fruit that was used during the proposed trial is Saudi's Dates extract know as Barni which is organic Dates. The fruit is mentioned more than 20 times in the Quran, This Barni is known for its very high nutritive value (vitamins, minerals and antioxidants) compared with other Dates types. The nutritive value of Barni is shown in the below table, calculated per every 100 gram (range 5- 10 pieces) of dry weight (DW) :
~The nutritive value of Barni calculated per every 100 gram (average 7-10 pieces) of dry weight (DW) of which iron constitutes 6.78 mg that represent 67.8 % of the recommended dietary allowance (RDA) of the males and 45.20 % of the RDA of the females"
15821534|NCT04271852|Device|bio-feedback treatment|50 patients will treated with phenix u2 and phenix u4 treating equipment。
15821535|NCT04271839|Combination Product|fluticasone/formoterol k-haler (medium strength)|2 inhalations every 12 hours
15821536|NCT04271839|Combination Product|Standard of care (ICs/LABA high strength)|Depend of the ICs/LABA combination
15821537|NCT04271826|Procedure|laparoscopic appendectomy|cases with normal CT underwent laparoscopic appendectomy
15821538|NCT04271813|Drug|Anlotinib plus Sintilimab|Anlotinib 12mg oral administration daily d1-d14, q3w; Sintilimab 200mg iv drop d1, q3w
15821539|NCT04271800|Biological|CD19 CAR-T cells|A single infusion of CD19-CAR-T cells will be administered intravenously.
15821540|NCT04271787|Other|questionnaire|Questionnaire
15821541|NCT04271761|Other|Non-interventional, post-market, pilot study of Carina Cochlear System|Several objective acoustic measurements will be performed that do not require active participation from the subject.
15821542|NCT04271748|Other|Time Restricted Feeding|The counseling on the regimen will involve instructing the subjects on study compliance and fasting times. Subjects will be instructed to choose an eight-hour eating window (e.g., 11:00am - 7:00pm) during which the patient will be able to eat his/her normal diet. During the 16-hour fasting window (e.g., 7:00pm - 11:00am), the participant will be able to drink regular water and black coffee.
15821545|NCT04271722|Other|Cervical ripening|Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
15821612|NCT04271137|Combination Product|3D printed PEEK onlay|3d computer-designed Orbital onlay
15821613|NCT04271137|Combination Product|Pre-bent orbital mesh|Pre-bent orbital mesh on 3d printed template
15821546|NCT04271709|Behavioral|Enhanced Intervention Using Patient Navigators|Enhanced support includes patient navigators to assist with all aspects of follow-up eye care and ocular surgery at either Harkness Eye Institute or Harlem Hospital, specifically eye exam appointment scheduling and arranging transportation over a 1-year period.
15821547|NCT04271709|Other|Usual Care|Usual Care subjects who fail the screening and need vision correction will be given an eyeglasses prescription and a list of optical shops within 1 mile from their home. These subjects who are referred to an ophthalmologist for a follow-up eye exam will only be scheduled for their initial appointment at either Harkness Eye Institute or Harlem Hospital. They will not receive enhanced support. Scheduling this initial appointment will allow tracking of adherence.
15821550|NCT04271670|Other|Ginger powder footbaths|20-minute footbath with 12 liters of 40°C warm water and an additive of 80g dried ginger powder (reaching up to mid-calf level)
15821551|NCT04271670|Other|Mustard powder footbaths|20-minute footbath with 12 liters of 40° C warm water and an additive of 80g dried mustard powder (reaching up to mid-calf level)
15821552|NCT04271670|Other|Warm water only footbaths|20-minute footbath with 12 liters of 40° C warm water without any additive (reaching up to mid-calf level)
15821553|NCT04271644|Biological|BCMA CAR-T cells|BCMA CAR-T cell therapy
15821554|NCT04271631|Other|Mobile Application-Based Diabetes Education|Additional education was given using application, subjects were asked to open the application at least once a day
15821555|NCT04271631|Other|Health Coaching|Health coaching was given as face to face with a coach
15821556|NCT04271618|Other|TheraTogs Orthotic Undergarment|Strapping undergarment made from a lightweight, breathable fabric that is velcro sensitive. It consists of sleeveless vest (tank-Top), two shorts (Hipster) each with two thigh cuffs and limb cuffs
15821557|NCT04271605|Behavioral|diet and exercise suggestion|diet and exercise suggestion according to blood biochemistry data and bone mineral density
15821558|NCT04271592|Drug|ABI-H3733 Liquid Oral Dosage Form|ABI-H3733 liquid oral dosage form
15821559|NCT04271592|Drug|ABI-H3733 Solid Oral Dosage Form|ABI-H3733 solid oral dosage form
15821560|NCT04271592|Drug|Placebo to ABI-H3733 Liquid Oral Dosage Form|Placebo to ABI-H3733 liquid oral dosage form
15821561|NCT04271592|Drug|Placebo to ABI-H3733 Solid Oral Dosage Form|Placebo to ABI-H3733 solid oral dosage form
15821562|NCT04271579|Procedure|Salvage Lymphnode dissection|"A salvage lymphnode dissection is performed in all study patients (both arms)using standard surgical techniques (openly or DaVinci).In patients who were randomized to the bilateral pelvic lymphnode dissection group, a salvage lymphadenectomy was also performed on the opposite side with resection of the corresponding fields that were removed on the PSMA-PET positive side (th Blinding must be guaranteed during pathological assessment)"
15821563|NCT04271566|Behavioral|Education program|A mobile application plus short message service (SMS) program to deliver disease-related health education and reinforcement to experimental group patients and see its impact on their health related quality of life, physical activity and Body mass index
15821564|NCT04271553|Other|Video|In addition to standard workflow, participants will also receive the PFO bundle which consists of: 1) A cartoon video of about 6 minutes duration illustrating the events occurring during admission, anaesthesia and surgery and 2) Sets of activity sheets which have been tailored for different age groups. Families would be encouraged to complete activity sheets together.
15821565|NCT04271540|Drug|Tildrakizumab|"Tildrakizumab, a p19 inhibitor which blocks IL-23 and Th17 mediated inflammation, will be given for 6 months. As below, a baseline cardiac PET scan and echocardiogram will be performed prior to initiation and after 6 months of treatment.
~Radiation: A cardiac PET scan will be performed at baseline and at 6 months
~Other cardiac Imaging: An echocardiogram will be performed at baseline and at 6-months."
15821566|NCT04271527|Procedure|cognitive fusion targeted biopsy|A novel three-dimensional matrix positioning based cognitive fusion targeted biopsy
15821567|NCT04271514|Drug|RPT193|Antagonist of the CCR4 chemokine receptor
15821568|NCT04271514|Drug|Placebo|Matching placebo
15821569|NCT04271501|Procedure|Melanocyte-Keratinocyte Transplantation and Ultraviolet Lamp (UVB)|Application of melanocytes (aka melanocyte-keratinocyte transplantation procedure or MKTP) to surgically prepared depigmented areas
15821570|NCT04271501|Device|RECELL 1:5 and Ultraviolet Lamp (UVB)|Skin cell suspension dilution prepared using the RECELL System applied to a surgically prepared area of depigmentation
15821571|NCT04271501|Device|RECELL 1:10 and Ultraviolet Lamp (UVB)|Skin cell suspension dilution prepared using the RECELL System applied to a surgically prepared area of depigmentation
15821572|NCT04271501|Device|RECELL 1:20 and Ultraviolet Lamp (UVB)|Skin cell suspension dilution prepared using the RECELL System applied to a surgically prepared area of depigmentation
15821573|NCT04271488|Drug|E7090|E7090 oral tablet.
15821574|NCT04271488|Drug|E7090|E7090 oral capsule.
15821577|NCT04271462|Other|Comparing two CO2 absorbers in the ventilator circuit|"General anaesthesia will be induced with a standardised regimen (propofol 0.8-2.5 mg·kg-1, sufentanil 0.2 - 0.5 µg·kg-1 and rocuronium 0.5 - 1 mg·kg-1). After tracheal intubation, anaesthesia will be maintained with sevoflurane targeted at 1 MAC end tidal concentration (corrected for age using the formula by Mapleson) in 40% O2. Different ventilator settings will be compared for 30 minutes (in randomised order):
~I. Sodalime, FGF 2.0 L min-1. II. Amsorb Plus®, FGF 2.0 L min-1. III. Soda lime, FGF, 0.5 L min-1. IV. Amsorb Plus®, FGF 0.5 L min-1. FGF=fresh gas flow."
15821578|NCT04271449|Device|tDCS (transcranial direct current stimulation)|"Non invasive functional brain stimulation that allows to modulate the excitability of a targeted area (inhibitory or excitatory) thanks to a small current that goes beyond two electrodes. For this arm, the targeted are will be the cerebellum.
~Prismatic googles will also be used in the same way in all groups during prism exposure."
15823613|NCT04255342|Other|recession|recession respective to the incisal/occlusal plane
15821579|NCT04271449|Behavioral|Virtual reality device|"Non invasive functional brain stimulation that allows to modulate the excitability of a targeted area (inhibitory or excitatory) thanks to a small current that goes beyond two electrodes. For this arm, the targeted are will be the cerebellum.
~Prismatic googles will also be used in the same way in all groups during prism exposure."
15821580|NCT04271449|Device|tDCS (transcranial direct current stimulation)|"Non invasive functional brain stimulation that allows to modulate the excitability of a targeted area (inhibitory or excitatory) thanks to a small current that goes beyond two electrodes. For this arm, the targeted are will be either the cerebellum or the primary motor cortex, but the stimulation will be turned off after 15 seconds to insure a sham condition.
~Prismatic googles will also be used in the same way in all groups during prism exposure."
15821581|NCT04271436|Device|FDG PET/CT|A single dose of 10 mCi FDG will be given by bolus injection approximately 60 minutes prior to the first planned imaging procedure.
15821582|NCT04271436|Device|FLT PET/CT|. A single dose of 10 mCi FLT will be given by bolus injection approximately 80 minutes prior to the first planned imaging procedure.
15821583|NCT04271436|Device|PET/MR|MR imaging will be performed on a Siemens Biograph mMR or an MRI scanner, if the PET/MR is unavailable.
15821584|NCT04271436|Drug|[F-18] flurothymidine|-Radiopharmaceutical
15821585|NCT04271423|Procedure|Ridge Preservation|Ridge Preservation using demineralized bone matrix and mineralized particulate allograft and covered with calcium sulfate barrier.
15821586|NCT04271410|Biological|CD19 CAR-T cells|CD19 CAR-T cell therapy
15821587|NCT04271397|Other|Multiple blood samples|Patients with active tuberculosis will have 5 research-specific blood samples: V1, (baseline) immediately before initiating anti-tuberculosis treatment, then 4 samples during anti-tuberculosis treatment and follow-up, i.e. at 48 hours (V2), 15 days (V3), 2 months (V4) and 6 months (V5) after initiation of treatment. The total volume of each sample will be 20 mL for a total of 100 mL.
15821588|NCT04271397|Other|Single blood sample|Patients with Latent tuberculosis infection will have a single specific sample of 14 mL.
15821589|NCT04271384|Combination Product|nivolumab|Combined neoadjuvant therapy consisting of nivolumab + SABR
15821590|NCT04271371|Other|Not yet developed|A prototype intervention will be developed over Phase 1 & 2 and piloted in Phase 3 of this study.
15821591|NCT04271358|Behavioral|Peer Health Coaching|The Peer Coaching group will receive 6 months of peer health coaching via a secure telephone and text messaging system.
15821592|NCT04271332|Drug|Arbaclofen|Arbaclofen tablet
15821593|NCT04271332|Drug|Placebo oral tablet|Manufactured to match Arbaclofen in size, shape, color and taste
15821594|NCT04271319|Device|BEST™ HVPC microcurrent electrical stimulation PRO-SPORT Ultra® Device|"Participants will receive treatment with an active electrical stimulation device for 7 in-clinic treatments over 2 weeks.
~Active Avazzia PRO-Sport Ultra® medical device, BEST™ HVPC microcurrent electrical stimulation, FDA cleared for pain relief"
15821595|NCT04271319|Device|Sham PRO-SPORT Ultra® Device|"Participants will receive treatment with a sham electrical stimulation device for 7 in-clinic treatments over 2 weeks.
~Sham PRO-SPORT Ultra® device will be used. The built in electrodes and the accessory port for connecting the lead wire to the electrode pads will be disconnected internal to the device. The device will power on with the same sounds and indications."
15821596|NCT04271306|Biological|Pfs25-IMX313 (10ug)/Matrix-M (50ug)|3 doses of Pfs25-IMX313/Matrix-M at Pfs25-IMX313(10µg)/Matrix-M (50µg)
15821597|NCT04271306|Biological|Pfs25-IMX313 (50ug)/Matrix-M (50ug)|3 doses of Pfs25-IMX313/Matrix-M at Pfs25-IMX313(50µg)/ Matrix-M (50µg)
15821598|NCT04271306|Biological|Pfs25-IMX313 (50ug)/Matrix-M (50ug) & Pfs25-IMX313 (10ug)/Matrix-M (50ug)|2 doses of Pfs25-IMX313/Matrix-M at Pfs25-IMX313(50µg)/ Matrix-M (50µg) followed by one at Pfs25-IMX313(10µg)/Matrix-M (50µg)
15821599|NCT04271293|Drug|Edoxaban|Edoxaban will be administered via PEG in patients who are eligible for the anticoagulant treatment according to the current guidelines.
15821600|NCT04271280|Other|Non-interventional|This is a non-interventional, observational study.
15821601|NCT04271267|Other|No Intervention|
15821603|NCT04271241|Other|Passive stretching (PS) training|PSBil and PSMono underwent 12 weeks of PS training, 3 sessions per week (36 sessions in total). In PSBil, each session lasted 40 min and included two maneuvers for both the knee extensor and plantar flexor muscles with the following protocol: 45 s elongation and 15 s recovery in the resting position, all the cycle repeated for five times 7. In PSMono, exercises were performed only on the right limb and each session had a duration of 20 min. Ctrl did not underwent any PS exercise throughout the study. To promote participants' compliance, daily classes were held at different day time (morning and afternoon) at the University Sports Centre gym. Each class was supervised by an expert operator, which monitored the attendance, the correct exercise execution and the intensity exerted during the exercise (80% of the point of discomfort). The participants not attending at least the 80% of classes were excluded from the study, and a new participant was recruited to substitute the drop out.
15821604|NCT04271228|Device|DreaMed Advisor Pro|Using the DreaMed Advisor Pro as an advisory tool for Health Care Professionals during routine clinical use
15821605|NCT04271215|Other|Chemotherapy protocol used|Chemotherapy protocol used in each participating hospital
15821606|NCT04271202|Drug|Emgality 120 MG in 1 ML Prefilled Syringe|Initial dose of 240 mg followed by 2 interventions (1 month apart) of 120 mg - all given as injectables.
15821607|NCT04271189|Drug|Metformin-Sitagliptin-Empaglifozin-Pioglitazone|1000 mg metformin (extended release) b.i.d., pioglitazone 15 mg b.i.d., sitagliptin 100 mg q.d., empaglifozin 10 mg q.d..
15821608|NCT04271189|Drug|Standard of care|Usual medical care to treat diabetes.
15821609|NCT04271163|Device|MemorEM|The MemorEM device is self-contained and has been designed for in-home daily electromagnetic treatment in the radiofrequency range to the entire forebrain, allowing for complete mobility and comfort in performing daily activities during treatment. The device has a custom control panel that is powered by a rechargeable battery. This control panel/battery box is worn on the upper arm and wired to specialized emitters in the head cap worn by the subject. Everyday for the 12M treatment period, the subject's caregiver will administer one or two 1-hour treatments (two daily treatments during the first 2M period).
15821610|NCT04271150|Device|Self-etch|Universal adhesive with self-etch mode
15821611|NCT04271150|Device|Total-etch|Universal adhesive with total-etch mode
15821614|NCT04271124|Other|exercise training|The patients are allocated to PR+ET group or PR Each group receive an exercise training
15821615|NCT04271111|Behavioral|Online Treatment for Interpersonal Stress|Intervention designed to build social support and reduce loneliness by giving participants skills to strengthen their relationships
15821616|NCT04271111|Behavioral|Physical Health Education Tool|Intervention designed to improve physical health through exercise, eating habits, and sleep
15821617|NCT04271098|Procedure|Open-Heart Surgery for nine months duration|In a single group of patients including 340 patients undergoing open-heart surgery during a period of nine months, the collected parameters include; alanine transaminase (ALT), aspartate transaminase (AST), alkaline phosphatase (ALP), total bilirubin (TBIL), and gamma-glutamyl transpeptidase (GGT) and albumin preoperatively and on postoperative days of 1, 3 and 7. All patients were divided into two groups as with or without hyperbilirubinemia, and this was defined by the occurrence of a plasma total bilirubin concentration of more than 34 µmol/L (2 mg/dL) in any measurement during the postoperative period. For each diagnostic test, a comparison within the group for different time points was statistically evaluated by analysis of variance tests.
15821618|NCT04271098|Other|Relation between possible risk factors and hyperbilirubinemia|Possible preoperative, intraoperative, and postoperative risk factors were investigated. The relations between hyperbilirubinemia and possible risk factors are sought by the use of the statistical analysis methods including logistic regression analysis.
15821619|NCT04271098|Other|Follow-up period|All patients were investigated for a period of ten days postoperatively. During this period, intensive care unit (ICU) stay, in-hospital stay, and all adverse events were recorded.
15821620|NCT04271085|Other|Observational study|No intervention involved
15821621|NCT04271072|Other|No intervention|No intervention
15821622|NCT04271046|Behavioral|STAR-C-VTF|"One 60 minute baseline orientation phone visit with a coach to get verbal consent for participation in the study and to acquaint the caregiver with the STAR-VTF components of good dementia care; distribute printed educational material (and links to same material online);
~Six 30-minute follow-up phone calls with the caregiver following each of the 6 learning modules to review STAR-VTF concepts, and further brainstorm strategies to modify identified activators and consequences with the objective of reducing behavioral symptoms;
~secure message support, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months."
15821623|NCT04271046|Behavioral|Control|"One 60 minute baseline orientation phone visit with a coach to get verbal consent for participation in the study. Controls will receive usual care from their primary care provider and/or psychiatrist. We will give participants an information package from the Alzheimer's Association including a list of resources. To assist with retention, and to measure responses to secure messages, we will send a template secure message to control dyads once per month in which we remind participants to contact their primary care provider if they have any issues with behavioral and psychological symptoms of dementia. Dyads in the attention control may receive information and training from their primary care provider and the Alzheimer's Association. This attention control is proposed to assess the additional impact of STAR-VTF above treatment as usual. Investigators do not intend to track non-study training receipt in the control arm."
15821624|NCT04271033|Device|Carotid Artery Stenting|"Carotid artery stenting according to local clinical experience and ESC/ESVS guidelines using exclusively CGuard™, MicroNet covered stent under proximal or distal intraprocedural cerebral protection according to tailored CAS algorithm."
15821625|NCT04271020|Device|UroLift|"The UroLift System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH).
~During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra."
15821626|NCT04271007|Drug|Mometasone Furoate|mometasone furoate
15821627|NCT04270994|Drug|Misoprostol|
15821628|NCT04270981|Drug|[14C]-acoziborole capsule, 240 mg containing NMT 9.25 kBq (250 nCi) 14C|960 mg (4 × 240 mg capsules)of acoziborole in oral and fasted condition
15821629|NCT04270968|Device|extra-corporeal shock wave therapy|Extracorporeal Shock Wave Therapy (ESWT) has been introduced efficiently for more than twenty years as a treatment modality in orthopedic and musculoskeletal disorders. ESWT has mechanical and cellular impacts on tissues regeneration and pain management through cavitation bubbles, acoustic micro streaming, and hyper-vascularity that can directly affect tissue calcifications, and modulate cell activity.
15821630|NCT04270968|Drug|topical none steroidal anti-inflammatory drug|participants received 1% topical diclofenac gel on the tender points 3 times /day for 4 weeks.
15821631|NCT04270955|Procedure|Embolization of the Middle Meningeal Artery|Using established endovascular techniques and materials patient will have a diagnostic catheter based angiogram performed on the side(s) of the brain where the subdural hematoma is present. After verifying the vascular anatomy to ensure safety of the procedure the Middle Meningeal Artery will be embolized.
15821632|NCT04270955|Procedure|Standard of care including possible surgical evacuation of subdural hematoma|Standard of care could include observation or intervention including surgical drainage of subdural hematoma by bedside drain, Subdural Evacuating Port System (SEPS), burr hole or craniotomy
15821633|NCT04270942|Biological|teplizumab|anti-CD3 humanized monoclonal antibody
15821634|NCT04270929|Drug|FOLFIRI|During Cycles 1 and 2, standard of care systemic FOLFIRI will be delivered on Days 2-4 following oxaliplatin PEDD-PRVI.
15821635|NCT04270929|Drug|FOLFIRINOX|During Cycles 3-6, standard of care systemic FOLFIRINOX will be administered on Days 1-3.
15821636|NCT04270929|Device|TriSalus Infusion System|The TriSalus Infusion System administers therapeutics using PEDD technology.
15821637|NCT04270916|Diagnostic Test|High frequency pure tone audiometry|Hearing test carried out routinely, non invasive
15821638|NCT04270903|Device|EPR measurement|Subject put in a magnet, magnetic field sweeping around 40 mTesla. Irradiation with a wave with a frequency of 1.1 GHz. A resonator (surface coil) is put at the surface of the skin (arm). The EPR signal is recorded.
15821639|NCT04270890|Device|Abdominal compression belt system|"The abdominal compression belt system is provided free of charge from CDR systems, Canada.
~The belt has specifically been chosen from other similar devices commercially available as it is independent of other immobilisation devices and can be used with the patient located within a full body vacbag as per current immobilisation position."
15821640|NCT04270877|Drug|Naltrexone Pill|Treatment with LDN for 12 weeks, including af titration phase of 4 weeks. Initial dosage of 1.5 mg, dose is increased by 1.5 mg every 7th day to 6 mg at week 4. Dosing is increased based on safety and tolerability and delayed increments are allowed. The participants are maintained on the highest tolerable dose for the last 8 weeks of the treatment period.
15821641|NCT04270877|Drug|Placebo oral tablet|Treatment with LDN-placebo for 12 weeks, including af titration phase of 4 weeks. Initial dosage of 1.5 mg, dose is increased by 1.5 mg every 7th day to 6 mg at week 4. Dosing is increased based on safety and tolerability and delayed increments are allowed. The participants are maintained on the highest tolerable dose for the last 8 weeks of the treatment period.
15821642|NCT04270864|Drug|Ipilimumab|20mg (4mL) IT
15821643|NCT04270864|Drug|Nivolumab|360mg IV then 480mg IV
15821644|NCT04270864|Drug|Tilsotolimod|8 mg (2mL) IT
15821645|NCT04270851|Diagnostic Test|LiMAx test|The LiMAx test is a fully licenced liver function test, testing liver maximum capacity via a breath test.
15821646|NCT04270851|Diagnostic Test|HepaT1ca magnetic resonance scan|The HepaT1ca scan is a pre-operative magnetic resonance scan providing a detailed report permitting interactive virtual pre-operative planning prior to liver surgery.
15821647|NCT04270838|Biological|ChAdOx2 RabG|Single dose of ChAdOx2 RabG at different concentrations: 1x10^10 and 5x10^10
15821648|NCT04270838|Biological|Inactivated Rabies Vaccine|A complete pre-exposure prophylactic course of an existing rabies vaccine, ≥2.5 international units
15821649|NCT04270825|Behavioral|Group CBT with IPT|Group treatment designed to target relationships with both possessions and people.
15821650|NCT04270812|Behavioral|Transdiagnostic Sleep and Circadian Intervention for Youth (TranS-C)|"TranS-C adopts a modular approach to reversing the psychosocial, behavioral, and cognitive processes maintaining sleep problems via 4 cross-cutting modules (introduced in the first session and included in every session thereafter), 4 core modules and 7 optional modules. TranS-C typically involves 6-8 individual, weekly 50-minute sessions."
15821651|NCT04270799|Diagnostic Test|Machine Learning Classification|Patient's scans will be used as input into in-house software to extract multiple radiomics features. These features will be used to develop a risk-signature which can predict malignancy risk. Patient scans will also be used as input into deep learning/convolutional neural network models to perform automated imaging classification.
15821652|NCT04270786|Procedure|Early de-escalation|In de-escalating group, the empirical antibiotics will be stopped and then prophylaxis levofloxacin will be resumed.
15821653|NCT04270786|Procedure|Standard|In the control arm, empirical antibiotics will be continue until recpvery of neutropenia or at least 7 days after afebrile.
15821654|NCT04270773|Biological|Human Papillomavirus 9-valent Vaccine, Recombinant|Vaccine administrated
15821655|NCT04270760|Drug|Olpasiran|Dose 1 Dose 2 Dose 3 Dose 4
15821656|NCT04270760|Drug|Placebo|Dose 5
15821657|NCT04270747|Drug|ABP 938|Subject will receive ABP 938 2 mg (0.05 mL) IVT injection every 4 weeks for the first 3 doses, followed by once every 8 weeks
15821658|NCT04270747|Drug|Aflibercept|Subject will receive aflibercept 2 mg (0.05 mL) IVT injection every 4 weeks for the first 3 doses, followed by once every 8 weeks
15821659|NCT04270734|Procedure|EEG|Response of the cortical network in premature aged between 25 and 36 wGA in response to auditory stimuli using High Resolution Electroencephalography will be performed
15821660|NCT04270734|Procedure|NIRS|Response of the cortical network in premature aged between 25 and 36 wGA in response to auditory stimuli using High Density Near Infrared Spectroscopy will be performed
15821661|NCT04270721|Behavioral|The EAGLE Safe Anastomosis Quality Improvement Intervention|"The intervention is the same in each arm; the EAGLE Safe Anastomosis Quality Improvement Intervention is an educational programme for behavioural change composed of three parts:
~Introduction of a routine patient risk stratification for anastomotic leak
~Implementation of the ESCP Safe Anastomosis Checklist
~Adoption of a harmonised technique for stapled and handsewn anastomosis based on best evidence."
15821662|NCT04270708|Drug|Dexmedetomidine|Patients with Autism will be treated with intranasal Dexmedetomidine as a sedative for EEG
15821663|NCT04270708|Drug|Triclofos 100 MG/ML|Patients with Autism will be treated with oral Triclofos as a sedative for EEG
15821664|NCT04270695|Other|blood flow restriction|an inflatable cuff (14 cm in width * 84 cm in length) is warped around abdominal muscles below ribs which may cause to at least 60% restriction of blood flow detected by Power Doppler ultrasonography. All participants are instructed to perform abdominal draw-in maneuver.
15821665|NCT04270682|Drug|Blinded CDCA 250 mg TID|Adult cohort patients will receive blinded 250 mg CDCA TID or placebo during the double-blind periods based upon their treatment assignment.
15821666|NCT04270682|Drug|Placebo|Adult cohort patients will receive blinded 250 mg CDCA TID or placebo during the double-blind periods based upon their treatment assignment.
15821667|NCT04270682|Drug|Open-Label CDCA 250 mg TID|Adult cohort patients will receive open-label 250 mg CDCA TID during the run-in and washout periods of the study or as rescue medication during the double-blind periods, if needed, based on clinical symptoms.
15821668|NCT04270682|Drug|Rescue Medication CDCA 250 mg TID|CDCA 250 mg TID will be provided as rescue medication during the double-blind periods, if needed, based on laboratory results.
15821669|NCT04270682|Drug|CDCA Weight-Based Dose TID|Patients in the pediatric cohort will complete a weight-based dose titration to a tolerated dose and will maintain that tolerated dose for the remainder of the study. Pediatric cohort dosing of CDCA will not exceed an equivalent dose of 750 mg/day.
15821670|NCT04270669|Biological|intravitreal injection of RC28-E 0.5mg|The patient received one treatment of RC28-E 0.5mg in the test group
15821671|NCT04270669|Biological|intravitreal injection of RC28-E 1.0mg|The patient received one treatment of RC28-E 1.0mg in the test group
15821672|NCT04270669|Biological|intravitreal injection of RC28-E2.0mg|The patient received one treatment of RC28-E 2.0mg in the test group
15821673|NCT04270656|Procedure|Insulin pump therapy|5-day hospitalization in case of randomization in the insulin pump group (insulin pump establishing in according to the recommendations of the HAS)
15821674|NCT04270656|Procedure|Multi-injection treatment ( MDI ).|Corresponds to an outpatient visit if the patient is randomized into the multi-injection group
15821675|NCT04270643|Dietary Supplement|Vitamin D3|ATC code A11CC05 (cholecalciferol)
15821676|NCT04270643|Dietary Supplement|Placebo|Ethyl oleate
15821677|NCT04270630|Behavioral|Shared Decision Aid|The decision aid was developed by this study group based on the International Patient Decision Aid Standards Collaboration's minimum standards for quality, and the Ottawa Framework (a process by which patients' and clinicians' decision determinants are assessed, a decision aid is developed that is tailored to these needs, and the quality of the decision-making process with the aid is evaluated). The aid then underwent an iterative feedback process with a patient advisory panel. Adjustments to format, length, and readability were made. A final feedback session occurred with three patients over the age of 70, after which point the paper decision aid was digitalized. The intervention will be delivered in-person by one of the co-investigators of the study. The intervention will occur once, prior to the patient making a final decision regarding undergoing left heart catheterization as treatment for NSTEMI. The approximate duration of the intervention is 30 minutes.
15821678|NCT04270617|Behavioral|Yoga program|The intervention will be a 6-week ashtanga yoga program designed by world-renowned yogi Eddie Stern. Eddie Stern is an internationally known Ashtanga yoga teacher, in independent practice not affiliated with NYULH, who has done significant work exploring the physiology and science of yoga. He is not currently engaged in his own research. The yoga protocol for chronic back pain was designed with poses specific to addressing core strength but are gentle enough for patients in pain. The protocol is designed to be directed by a teacher initially but can be done at home and is only 18 minutes in duration.
15821679|NCT04270604|Other|Biological sample collection|Biological sample collection for biobanking and research
15821680|NCT04270591|Drug|Glumetinib|The investigational product will be orally administrated when fasting at dose level of 300mg QD
15821681|NCT04270565|Behavioral|In-Field Gait-Training|The intervention will deliver a series of vibrations on the participants' wrists through the Garmin when the sensors indicate that their contact time in milliseconds exceeds a threshold. The runners will be asked to reduce the amount of time their foot is in contact with the ground by picking their feet up more quickly. Participants will also receive a series of exercises based on noted impairments at baseline. The feedback during running will be completed twice per week for four weeks.
15821682|NCT04270565|Behavioral|Home Exercise|Participants will receive a series of exercises based on noted impairments at baseline. Exercises will be completed twice per week for four weeks.
15821683|NCT04270552|Drug|Ismigen|Sublingual tablets containing 7 mg of bacterial lysate from the following bacteria: Staphylococcus aureus, Haemophilus influenzae serotype B, Klebsiella pneumoniae, Klebsiella ozaenae, Neiserria catarrhalis, Streptococcus viridans, Streptococcus pyogenes, Streptococcus pneumoniae (6 strains: TY1/EQ11, TY2/EQ22, TY3/EQ14, TY5/EQ15, TY8/EQ23, TY47/EQ24) - sublingual use 1 tablet per day over 10 days for 3 successive months.
15821684|NCT04270552|Drug|Placebo|Matched tablets without any active substance.
15821685|NCT04270539|Behavioral|Nap|Participants will be given 20-min nap opportunity in the classroom on a daily basis during school-days.
15821686|NCT04270526|Drug|Bicarbonate protocol|Intradetrussor treatment with 50 mL 1% lidocaine + 45ml of 0.9% normal saline + 5 mL 8.4% sodium bicarbonate
15821687|NCT04270526|Drug|Standard protocol|Intradetrussor treatment with 50 mL 1% lidocaine + 50ml of 0.9% normal saline
15821688|NCT04270513|Other|Endovascular treatment by Flying Intervention Team|After telemedicine-assisted decision for endovascular treatment, the Flying Intervention Team is transferred via helicopter to the primary stroke center and performs endovascular treatment in the local angiography suite.
15821689|NCT04270500|Behavioral|Prehabilitation program|The preoperative period (prehabilitation) represents a more appropriate time than the postoperative period to implement an intervention. Prehabilitation is a process of enhancing an individual's functional capacity before the scheduled surgery, aimed at improving the patient's tolerance to upcoming physiologic stress, by three principal elements: exercise training, nutritional intervention, and psychological support.
15821690|NCT04270487|Other|IBS Diet|Patients will be randomized to a diet or a mediation treatment
15821691|NCT04270487|Drug|Otilonium Bromide|Patients will be randomized to a diet or a mediation treatment
15821692|NCT04270474|Other|Deprescribing of target anticholinergics|The active intervention group (ACT) will receive a pharmacist-based deprescribing intervention focused only on targeted anticholinergic medications. The intervention pharmacist will serve as the central source of communication between participants, providers, and (as needed) dispensing pharmacy to coordinate the deprescribing process. The study pharmacists will navigate a shared-decision model between the physicians and participant in order to personalize the selection of appropriate alternatives and switch/titration schedules. Importantly, the pharmacist will supervise the titration and deprescribing plan and communicate with both participants and physicians throughout the study.
15821693|NCT04270474|Other|Usual Care|Those in the usual care group will not have access to the study intervention, but will receive a one-time information packet through the mail reviewing risks of polypharmacy, but no information specific to anticholinergic medications. They will receive clinical care as usually provided by their primary care or specialty care physicians.
15821694|NCT04270461|Biological|NKG2D-based CAR T-cells|Autologous genetically modified anti-NKG2DLs CAR transduced T cells
15821695|NCT04270448|Behavioral|Motor Sequence Task|"Participants will be seated at a laptop with the right hand on a standard joystick. The movement of the joystick will move a cursor on the computer screen. Targets will appear on the laptop screen as a circle in one of twelve spatially distinct locations. The learner must move the joystick cursor to inside the target before the next target will appear."
15821698|NCT04270409|Drug|Isatuximab SAR650984|Pharmaceutical for: Solution for infusion Route of administration: Intravenous
15821699|NCT04270409|Drug|Lenalidomide|Pharmaceutical form: Capsules Route of administration: Oral
15821700|NCT04270409|Drug|Dexamethasone|Pharmaceutical form: Tablets and solution for injection Route of administration: Oral and intravenous
15821701|NCT04270396|Behavioral|Presence or absence of implant|We procedure to observed clinically the sample size, to be able to determine if the dental implant was present or no. If the implant was absent we recorded if it was early( prior to restoration) or late ( after prosthesis was delivered).
15821702|NCT04270370|Drug|LY3478045|Administered orally.
15821703|NCT04270370|Drug|Placebo|Administered orally.
15821704|NCT04270370|Drug|Atorvastatin|Administered orally.
15821705|NCT04270357|Procedure|Cholecystectomy|Cholecystectomy is the surgical removal of the gallbladder. Cholecystectomy is a common treatment of symptomatic gallstones and other gallbladder conditions
15821706|NCT04270344|Drug|Pitavastatin 4mg|combination therapy with pitavastatin/valsartan (LivaloV)
15821707|NCT04270331|Other|PADS protocol|Assessment and management per PADS protocol
15821708|NCT04270318|Other|CH Pulpotomy, physiologic saline|Pulp chamber was cleansed with physiologic saline for 30 s.
15821709|NCT04270318|Other|CH pulpotomy, NaOCl|Pulp chamber was cleansed with 5 % NaOCl for 30 s.
15821710|NCT04270318|Other|MTA Pulpotomy, physiologic saline|Pulp chamber was cleansed with physiologic saline for 30 s.
15821711|NCT04270318|Other|MTA pulpotomy, NaOCl|Pulp chamber was cleansed with 5 % NaOCl for 30 s.
15821712|NCT04270305|Other|Orientation|In the first group CP patients undergo a four week training with once daily sessions lasting 30 minutes. The treatment includes exercises to improve navigation competences and orientation. During walk in VR environment with labyrinths of increasing complexity. Exercises include abilities such as orienting in complex environments, perceiving distance and planning routes to distant locations. The presence of landmarks has been included in some exercises to facilitate allocentric orientation strategies.
15821713|NCT04270305|Other|walking|In the second group CP patients undergo a four week training with once daily sessions lasting 30 minutes. The treatment includes exercises to improve walking and balance abilities. Using engaging VR environments (e.g. transfer your load from the left to the right side to avoid obstacles while skiing; shoot balls at targets inside an area; walk in a forest as fast as possible; hit as many elves as possible by squatting, and so on). No exercises for orientation are included in this group.
15821714|NCT04270279|Drug|Xueshuanxinmaining tablet|A kind of Chinese patent medicine
15821715|NCT04270279|Drug|Xueshuanxinmaining placebo|The simulant of Xueshuanxinmaining tablet
15821716|NCT04270279|Drug|Nitroglycerin tablets|Be used when angina attack
15821717|NCT04270266|Other|Educational Intervention|Attend educational sessions
15821718|NCT04270266|Other|Meditation Therapy|Attend meditation sessions
15821719|NCT04270266|Other|Questionnaire Administration|Ancillary studies
15821720|NCT04270253|Procedure|Conservative therapy|Conservative therapy including aquatic exercises, land-based exercises, balneotherapy, TENS therapy
15821721|NCT04270253|Procedure|Manual therapy|End-range mobilization
15821722|NCT04270227|Other|Survey study|The questionnaire including Exercise Benefits / Barriers Scale, IPAQ (International Physical Activity Survey), The Bady Awareness questionnaire and demographic information will be filled in one time by face-to-face interview method.
15821723|NCT04270214|Drug|Dysport Injectable Product|Dysport injections optimized using kinematics
15821724|NCT04270201|Other|Saliva collection|Saliva collection
15821725|NCT04270188|Other|evolution of patient symptoms|evolution of symptoms on the PGI-I scale (score 1, 2, or 3) 2 months after surgery
15821726|NCT04270175|Drug|Daratumumab|Given as 1800mg via injection
15821727|NCT04270175|Drug|Pomalidomide|Given as 4mg oral capsule
15821728|NCT04270175|Drug|Dexamethasone|Given as 20mg or 40 mg IV and 20mg or 40mg oral capsule.
15821729|NCT04270162|Device|Respiratory muscle training 1|"For inspirometer, the participant sits and holds the device. Then put the mouthpiece of the inspirometer in the mouth. Be sure to make a good seal on the mouthpiece with your lips. And exhale (exhale) normally until you run out of air. And after that, inhale (inspire) slowly as much as possible. This maximum value will be taken as an indicative parameter of its maximum inspiratory capacity and 50 and 80% of that value will be determined so that the participant performs 1 set of 10 repetitions at 50% of their maximum value, 2 sets of 10 repetitions at 60% of its maximum capacity and ends with 1 series at 80% of its maximum capacity.
~It is highlighted that in each series before finishing and without stopping to rest, the participant must do 5 repetitions at 100% maximum capacity.
~In addition, the respiratory exercises that will be carried out by the 3 intervention groups."
15821730|NCT04270162|Other|Respiratory muscle training 2|"Training of respiratory muscles under the protocol of conventional use. Which is that the participant sits and holds the device. Then put the mouthpiece of the inspirometer in the mouth. Be sure to make a good seal on the mouthpiece with your lips. And exhale (exhale) normally until you run out of air. And after that, inhale (inspire) slowly as much as possible. Repeat 10 times and use these indications for 3 sets.
~In addition, participants must perform different breathing exercises that are identical for the 3 intervention groups."
15821731|NCT04270162|Other|Respiratory muscle training 3|The same exercises that apply to the participants of experimental group 1 and 2 will be performed. The only difference is that the participants of this group do not perform exercises with inspirometer.
15821732|NCT04270149|Biological|ESR1 peptide vaccine|ESR1 peptides plus Montanide and GM-CSF
15821733|NCT04270136|Procedure|total mastectomy|breast cancer non conserving surgery
15821734|NCT04270123|Other|EORTC QLQ-BR45 questionnaire|The EORTC QLQ-BR23 questionnaire has been updated with a further twenty-two items to create the EORTC QLQ-BR45. This updated questionnaire contains items to encapsulate advancements in knowledge about the epidemiology of breast cancer and side effects experienced with new treatments. This study will test the psychometric properties of the EORTC QLQ-BR45 as a measure of quality of life in patients with breast cancer.
15821735|NCT04270084|Behavioral|Alive-Family|All participants receive lifestyle modification through use of m-health app
15821736|NCT04270071|Drug|Yangxin Shengmai|Yangxin Shengmai Granules
15821737|NCT04270071|Drug|Yangxin Shengmai placebo|Yangxin Shengmai placebo have an identical appearance and scent as the active treatment granules.
15821738|NCT04270071|Drug|nitroglycerin tablets|Be used when angina attack
15821739|NCT04270058|Drug|inotersen|TEGSEDI injection, for subcutaneous use
15821740|NCT04270045|Device|Non-invasive forced airway oscillometry|This non-invasive device will measure pulmonary mechanics in spontaneously breathing premature infants. Infant will be in supine position and breathing regularly. A cushioned mask will be placed on the infant's face, covering the nose and mouth. Measurements typically take less than 20 seconds and no more than 3 repetitions will be done at each time point.
15821741|NCT04270032|Diagnostic Test|ABUS|Using deep learning method to analyze and extract the features of automated breast ultrasound images
15821885|NCT04268771|Biological|Experimental: Arm A: DRL_RI|Proposed rituximab biosimilar, 100mg or 500mg, concentrate for solution for infusion
15821742|NCT04270019|Drug|Polyethylene Glycol 3350|In order to prepare PEG 3350 50% weight/volume, 25 grams of the sterilized PEG 3350 will be measured out and placed into a sterilized glass bottle then 25 mL of sterile water will be added. The solution will be allowed to rest for 10 minutes so that dissolution may occur. More sterile water will then be added so the total volume is 50mL. This solution will then be sterilized by the Halifax Health Infirmary pharmacy department using a liquid autoclave cycle of 120 degrees Celsius for 20 minutes in a glass vial. The 50 mL solution will be portioned into 2mL sterilized glass vials using a standard aseptic technique. The solutions will be kept at a solid frozen state between negative 25 degrees Celsius and negative 10 degrees Celsius for a maximum of 45 days. The solutions will be removed from storage on the day of surgical utilization in order to ensure storage guidelines are kept to the highest standards.
15821743|NCT04270019|Drug|Normal Saline|Standard solution of sterile normal saline.
15821744|NCT04270006|Biological|adipose derived stem cells exosomes|they are small extracellular vesicles
15821745|NCT04269993|Drug|Cannabis: placebo and medium THC/medium CBD|Vaporized cannabis: placebo and medium THC/medium CBD
15821746|NCT04269980|Other|MAP|MAP
15821747|NCT04269967|Other|Receiving routine rehabilitation care via tele-rehabilitation system|Drain care education, self-massage techniques and exercise (PT and OT)
15821748|NCT04269954|Drug|Batroxobin combined with low molecular weight heparin|Standard treatment of Batroxobin combined with low molecular weight heparin
15821749|NCT04269941|Other|total or subtotal gastrectomy|resection of the gastric tumor
15821750|NCT04269928|Procedure|Endovascular chemical ablation of adrenal gland|Patients in this group will be treated with ablation of adrenal gland by endovascular injection of dehydrated alcohol
15821751|NCT04269915|Biological|female Schistosoma mansoni cercariae|Viable female Schistosoma mansoni cercariae of the Puerto Rican strain
15821757|NCT04269876|Dietary Supplement|Marine Lipid Oil Concentrate|Marine Lipid Oil Concentrate softgels
15821758|NCT04269876|Dietary Supplement|Dietary Supplement|Dietary Supplement capsules
15821759|NCT04269876|Dietary Supplement|Placebo|Placebo softgels
15821760|NCT04269876|Dietary Supplement|Placebo|Placebo capsules
15821761|NCT04269863|Drug|Aspirin|control - 81mg. treatment - 81-325mg.
15821762|NCT04269850|Biological|allogeneic fecal microbiota|Single dose of capsules with fecal transplant (capsules for adults - 400-815mg, for adolescents - 280-500mg, for children - 160-320mg) - 2 capsules/kg body weight, divided in two consecutive days Additional supportive therapy after FMT include omeprazole 40mg po, inulin 1gr x 4 times a day po, metoclopramide 40mg po.
15821763|NCT04269850|Drug|Ruxolitinib|Ruxolitinib starting dose 10 mg bid. In case of grade 4 hematological toxicity dose can be reduced by 25-75%.
15821764|NCT04269850|Drug|Methylprednisone|Methylprednisone starting dose 0.5 mg/kg bid IV or oral, with subsequent tapper by 0.1 mg/kg every 5 days.
15821765|NCT04269837|Other|Counseling|Receive sexual health counseling
15821766|NCT04269837|Other|Quality-of-Life Assessment|Ancillary studies
15821767|NCT04269837|Other|Questionnaire Administration|Ancillary studies
15821768|NCT04269824|Behavioral|Behavioral intervention package|"Community mobilization and commitment events
~Update factual beliefs
~Establish public commitment
~Update empirical expectations about toilet use
~Audio announcements - Disseminate norms-related messages regarding toilet use and ownership
~Group level
~- Facilitated sex-segregated group meetings to share information and action knowledge through increased social connections
~Network-level social media messages - Transmit norms-related messages, and testimonials of adopters through influential social network members
~Household-level Counseling visits
~Update empirical expectations of improved sanitation behaviors in their community
~Motivate improved sanitation practices
~Build capacity to achieve exclusive toilet use
~Stickers/decals
~- Signal adoption of promoted behaviors to community members
~Individual-level
~Update empirical expectations of improved behaviors among similar others
~Set goals, track progress and maintain improved behavior"
15821769|NCT04269811|Drug|Flu-Bu-Mel|5-day fludarabine + 2-day busulfan (3.2mg/kg) + 2-day melphalan (50-70mg/m2)
15821770|NCT04269798|Other|Traditional Treatment|conventional rehabilitation program for lower limb, balance and gait training
15821771|NCT04269785|Device|Cryoballoon ablation|Ablation aimed at performing pulmonary vein isolation for atrial fibrillation using cryoballoon catheter (cold therapy)
15821772|NCT04269785|Device|Radiofrequency ablation|Ablation aimed at performing pulmonary vein isolation for atrial fibrillation using radiofrequency catheter (heat therapy)
15821773|NCT04269772|Behavioral|CARE|Hybrid in-person and telephone-based adjunctive intervention for bipolar disorder across the transition from prison to the community.
15821774|NCT04269772|Other|Treatment As Usual|Treatment as usual, unrestricted, as provided by prison and community providers.
15821775|NCT04269759|Other|Survey|pregnant women will answer to a survey regarding their oral health knowledge, attitudes and practices for themselves and their unborn child
15821776|NCT04269759|Other|dental care|pregnant women will have a dental care
15821777|NCT04269746|Diagnostic Test|CCAT1|Long Non coding RNA
15821778|NCT04269733|Device|Right ventricular pacing|Right ventricular pacing from a DDD pacemaker implanted due to high-degree AV block
15821779|NCT04269720|Behavioral|Biofeedback|They will also be taught how to use the biofeedback app and Inner Balance device. Additionally, they will also be educated on the principles of biofeedback and its benefits and taught how to maximize HRV by using self-regulation breathing techniques, guided imagery, and/ or self-talk.They will be given an Inner Balance device, which is an ear sensor that connects to an apple device that measures heart rate variability (HRV) and gives them access to an app that is designed to help them improve their HRV. They will be asked to use this device daily for 10 mins for the duration of the 8-week intervention. Patients and the research coordinator will have access to all of their sessions and results. The research coordinator will monitor compliance via the Heartcloud associated with their device and encourage adherence throughout the 8-week biofeedback intervention.
15821780|NCT04269707|Drug|Ferric carboxymaltose|IV iron
15821781|NCT04269694|Drug|Medihoney dressing|Medihoney is a mixture of two honeys derived from Australia and New Zealand containing glucose oxidase and Leptospermum compounds which contribute to its antibacterial activity.
15821782|NCT04269694|Device|Medihoney dressing|Medihoney is a mixture of two honeys derived from Australia and New Zealand containing glucose oxidase and Leptospermum compounds which contribute to its antibacterial activity.
15821783|NCT04269681|Device|High Flow Nasal Cannula|"Experimental intervention (HFNC) The HFNC (AIRVO 2 - Fisher & Paykel Healthcare, Auckland, New Zealand) consists of a device that allows FiO2 adjustable from 21 to 100% and that delivers a flow of humidified and heated gas up to 60 l / min and 37 degrees C of temperature.
~The HFNC will be offered until resolution of the ARF or until decision by the assisting team and the patient and/or their legal guardian, for the suspension of the treatment due to intolerance, and/or worsening of the discomfort and / or dyspnea.
~The HFNC should be offered to the patient in ARF as follows:
~Initial parameters: Flow 45 ml / L, FiO2 50%, AIRVO 37oC temperature;
~Titrate the flow up to 60ml / L or up to the maximum tolerated;
~Titrate FiO2 to maintain SatO2 between 92% to 98%, starting with 50%;
~Keep the AIRVO temperature at 37oC, if not possible, acceptable down to 34oC."
15821784|NCT04269681|Other|Standard respiratory support|The patient randomized to standard respiratory support will be placed on conventional low flow oxygen therapy according to the center's standard of care aiming at SpO2 90 - 98% and improvement of dyspnea. For cases refractory to oxygen therapy, keeping SpO2 below 90% or if dyspnea does not improve, non-invasive positive pressure ventilation (NIPPV) may be offered at the discretion of the assistant team. NIPPV will be performed with the patient in a supine position at 45 degrees. The mask will be facial (oronasal or full face) with an appropriate size for each patient and adapted in a way to minimize leakage. A hydrocolloid dressing can be placed over the nose in order to avoid ulcerations and increase comfort. The NIPPV will be performed with the help of a ventilator with inspiratory and expiratory circuits or with Bilevel devices with a single circuit and exhalation valve according to the availability of each center.
15821785|NCT04269668|Device|Medtronic Minimed 670G 3.0 HCL|Hybrid closed loop system
15821786|NCT04269668|Device|Medtronic Minimed 670G 4.0 AHCL|Advanced hybrid closed loop system
15821787|NCT04269655|Device|Cloud-Based Continuous Glucose Monitoring|The CGM data will be transmitted via bluetooth to a smartphone. The smartphone will automatically transmit values to a secure cloud-based platform, which then populates to the: (1) web-based, CGM data management tool for evaluation purposes (both groups), and (2) Digital Dashboard for monitoring and intervention (intervention only).
15821788|NCT04269642|Drug|PT320 2.0mg Placebo|PT320 2.0mg Placebo
15821789|NCT04269642|Drug|PT320 2.0 mg|Exenatide slowly released formulation
15821790|NCT04269642|Drug|PT320 2.5 mg|Exenatide slowly released formulation
15821791|NCT04269629|Drug|Insect Venom|Patients receive insect venom immunotherapy. The frequency of systemic side-effects is recorded and compared between patients under antihypertensive treatment and patients not taking antihypertensive drugs.
15821792|NCT04269616|Behavioral|Order of pictographs provided to participants|The pictographs presented to participants about survival and disability were varied in the order in which they were presented (i.e. survival or disability information first).
15821793|NCT04269616|Behavioral|Level of description in survival pictograph|The pictographs presented to participants about survival and disability were varied in the level of description provided in the survival pictograph (i.e. only numerical data, or also a description of course of NICU stay).
15821794|NCT04269603|Device|Take blood (TA-8V (Stago®)|Healthy volunteers will have 3 blood samples at M0, M3 and M6.
15821795|NCT04269590|Behavioral|Dual Task (DT) training|Participants will practice the Swipe Slide Pattern (SSP) task in combination with a secondary task, i.e. counting red or green lights. On day 1, participants perform 2 runs of the SSP-task (only one pattern), each lasting approx. 10 min, within an MR scanner. During each run, 9 trials of 30s are performed, alternated with rest periods of 14s. Instructions are provided before each trial (i.e. view of the pattern in combination with instruction to count red or green lights, 4s), as well as an answer option (i.e. participants have to indicate how many red or green lights they counted by circling a number from zero to nine, 6s). For the following 4 days, participants will continue practice of the SSP-task at home. During the at-home-sessions, participants will perform 9 trials of 12 patterns each, alternated with rest periods of 14s. Instruction and answers are also included. During at home practice, the same pattern as during scans is included, in combination with 2 new patterns.
15821796|NCT04269590|Behavioral|Single Task (ST) training|Participants will practice the Swipe Slide Pattern (SSP) task without the presence of a secondary task. On day 1, participants perform two runs of the SSP-task (only one pattern), each lasting approx. 10 min, within an MR scanner. During each run, nine trials of 30s are performed, alternated with rest periods of 14s. In addition, instructions are provided before each trial (i.e. view of the pattern, 4s), as well as an answer option (i.e. participants have circle a random number from zero to nine, 6s). For the following four days (day 2-5), participants will continue practice of the SSP-task at home. During the at-home-sessions, participants will perform nine trials of 12 patterns each, alternated with rest periods of 14s. Instruction are also included. During at home practice, the same pattern as during scans is included, in combination with two new patterns.
15821797|NCT04269577|Behavioral|SSP training|Participants will practice the Swipe Slide Pattern (SSP) task. On day 1, participants perform two runs of the SSP-task (only one pattern), each lasting approx. 10 min, within an MR scanner. During each run, nine trials of 30s are performed, alternated with rest periods of 14s. In addition, instructions are provided before each trial (i.e. view of the pattern, 4s), as well as an answer option (i.e. participants have circle a random number from zero to nine, 6s). For the following four days (day 2-5), participants will continue practice of the SSP-task at home. During the at-home-sessions, participants will perform nine trials of 12 patterns each, alternated with rest periods of 14s. Instruction are also included. During at home practice, the same pattern as during scans is included, in combination with two new patterns.
15821825|NCT04269278|Drug|0.5 ul of dexmedetomidine|Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0.5 ul) using dexmedetomidine
15821826|NCT04269278|Drug|0.75 ul of dexmedetomidine|Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0.75 ul) using dexmedetomidine
15821827|NCT04269265|Biological|Yellow Fever Vaccine|YF-VAX®, Yellow Fever Vaccine, for subcutaneous use
15821828|NCT04269252|Other|CHI-907|CHI-907 is a high CBD extract.
15821798|NCT04269564|Device|stepwise PEEP|"a PEEP of 4 cmH2O will be used after intubation till 5 minutes after pneumoperitonium, and adjusted in a step wise approach after lung ultrasound by adding 2 cmH2O, repeating ultrasound 5 minutes after every change in peep till no lung collapse is detected by lung ultrasound with a maximal peep of 10 cmH2O, or if hemodynamic instability occurs.
~Lung ultrasound examination will be performed at a minimum three times in each patient; the first will be performed 1 min after starting mechanical ventilation of the lungs, 5 minutes after pneumoperitonium, 5 min after every peep increase in stepwise peep group and the last time at the end of the surgery.
~We define anaesthesia-induced atelectasis to be significant if any region has a consolidation score of ≥ 2."
15821799|NCT04269551|Drug|BIVV020|Pharmaceutical form:solution for injection Route of administration: intravenous
15821800|NCT04269538|Drug|PF-06480605|PF-06480605 150 mg and 450 mg SC dosing
15821801|NCT04269538|Drug|Placebo|Placebo SC dosing
15821802|NCT04269525|Biological|UC-MSCs|After enrollment, each subject will receive UC-MSCs infusion intravenously on day 1, day 3, day 5, and day 7.
15821804|NCT04269499|Device|QuiremSpheres®|Radioembolization with QuiremSpheres® under MR imaging
15821805|NCT04269473|Procedure|Telehealth Gait Retraining|Telehealth gait retraining is a novel approach to train participants to adopt a non-rearfoot foot strike pattern during running via telecommunications. During telehealth gait retraining, video of a participant's running form are sent to clinicians over a mobile device app and running form feedback is given. This process is repeated once a week for four weeks and then every other week until week 8.
15821806|NCT04269473|Procedure|Standard Physical Therapy Treatment|Participants receiving standard Physical Therapy will visit the Physical Therapy Clinic every 2 to 3 weeks to be treated by a Physical Therapist.
15821807|NCT04269473|Procedure|Return to Running Protocol|The Return to Running protocol is a six-phase running volume progression to re-introduce running slowly and safely after experiencing a running-related injury.
15821808|NCT04269473|Procedure|At Home Exercise Program|The At Home Exercise Program consists of 4 lower leg and foot exercises that participants can perform on their own time.
15821809|NCT04269460|Drug|Bupivacaine Hydrochloride 0.25% Injection Solution [MARCAINE]|preoperative ultrasound guided subcostal TAP block and Quadratus lumborum block using 1 ml/kg of Bupivacaine Hydrochloride 0.25%in pediatric patients undergoing pyeloplasty surgeries.
15821810|NCT04269447|Diagnostic Test|Structured imaging follow-up|Structured imaging follow-up protocol with ultrasound (US) and computed tomography (CT) examinations as compared to current standard surveillance protocol for individualized estimations of AAA growth.
15821811|NCT04269434|Other|No Screening|the STI Laboratory will only process the samples/report the results from the non-screening arm at the end of the study.
15821812|NCT04269421|Procedure|calcaneo-stop: arthrosis of the subtalar joint|arthrosis of the subtalar joint with a screw in the talus bone to stop pathological pronation of the heel
15821813|NCT04269408|Drug|Nicardipine|10 NicaPlant® implants releasing 4 mg nicardipine each.
15821814|NCT04269408|Other|Standard of care|Both arms receive the usual standard of care.
15821815|NCT04269395|Drug|MAL Cream|No intervention will be administered as a part of this study. Participants who received MAL cream in RD.06.SPR.112199 study will be rolled over in the study.
15821816|NCT04269395|Drug|Vehicle cream|No intervention will be administered as a part of this study. Participants who received vehicle cream in RD.06.SPR.112199 study and achieved complete response, will be rolled over in the study.
15821817|NCT04269382|Device|Combined non-invasive intermittent (oscillometric arm cuff), non-invasive continuous (finger cuff and ClearSight device), and invasive continuous (intra-arterial catheter) BP measurements|Continuous (finger cuff) noninvasive and invasive BP measurements, over a 30-min period. Pairs of noninvasive/invasive BP recorded each minute). In the same time, 3 pairs of oscillometric NIBP (cuff placed around a calf), and invasive BP measurements, at 30-sec intervals. The cuff is then placed around an arm and triplets of BP (arm cuff, finger cuff, intra-arterial catheter) will be taken over a 20-min period, at 3-min intervals and every time the invasive and/or the continuous finger cuff measurements cross the threshold of 65 mmHg for the mean BP. If clinically indicated, a cardiovascular intervention that can be either vascular volume expansion or initiation of vasoactive drug therapy, can be administered during this period. Finally, the cuff placed around the arm will be once again placed around the calf to take 3 pairs of oscillometric NIBP measurement with cuff placed around a calf, and simultaneous invasive BP measurement, at 30-second intervals.
15821818|NCT04269369|Drug|5-Fluorouracil|"The aim of this study is to investigate if the systematic implementation of pre-emptive geno- and phenotyping, and therefore a dose reduction based on the French guidelines and the literature during the first month of treatment, reduces grade 3 or greater toxicity in patients treated with 5-FU or capecitabine. Therefore a dosing table was obtained by combining the results of the study by Henricks et al., Launay et al. and Yang et al. and the recommendations from the French HAS guideline. The treatment schedule then will be discussed by the team of doctors and paramedics at the weekly MOC (multidisciplinary cancer consultation). Complementary, the pharmacist provides dose advice with regard to the start of 5-FU or capecitabine treatment.
~In a subgroup, the group of patients with genotype wild type and phenotype intermediate metabolizer, a comparison will be made between group A with dosage according to French guidelines and group B with dosage according to literature."
15821819|NCT04269356|Drug|BMS-986256|Specified dose on specified days
15821820|NCT04269356|Drug|Milk of magnesia|Specified dose on specified days
15821821|NCT04269330|Procedure|Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial.|Comparison of normal and small size mesh in open inguinal hernia repair: Multicenter Prospective Randomized Controlled Trial.
15821822|NCT04269317|Device|Tixel C|Thermo-mechanical technology for fractional treatment of human skin. Dermal heating and coagulative effect that occur during the treatment session provide for dermal remodeling and collagen restructuring that promote acne scar appearance improvement.
15821823|NCT04269278|Drug|0 ul of dexmedetomidine|Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0 ul) using dexmedetomidine
15821824|NCT04269278|Drug|0.25 ul of dexmedetomidine|Venous blood is taken from 11 healthy volunteers and divided into four specimen bottles, which were added with different doses (0.25 ul) using dexmedetomidine
15821830|NCT04269239|Behavioral|Healthy Habits|Participants in this group will be coached during four hour-long sessions on topics such as physical activity, nutrition, pain coping skills, bladder health, diabetes, heart health, eyes/vision, hearing, and doctor-patient communication.
15821831|NCT04269239|Behavioral|Sleep Habits|Participants in this group will be coached during four hour-long sessions on topics such as sleep education, sleep restriction, stimulus control, cognitive restructuring, sleep hygiene education, and relapse prevention.
15821832|NCT04269226|Procedure|Recruitment maneuver|Following intubation, patients will be ventilated according to the ideal weight within the scope of intraoperative protective ventilation strategy and in pressure-controlled ventilation (PCV) mode. Then, automatic recruitment maneuver will be applied to the recruitment group twice, after insufflation and desufflation. It will not be applied to the control group. During recruitment maneuver, PEEP (Positive end-expiratory pressure), where dynamic compliance is measured highest, will be the ideal peep for the patient, and PEEP will be adjusted at this value after recruitment.
15821833|NCT04269226|Procedure|No recruitment maneuver|Usual ventilation procedures will be applied.
15821835|NCT04269200|Drug|olaparib|Olaparib tablets
15821836|NCT04269200|Biological|durvalumab|Durvalumab by intravenous infusion
15821837|NCT04269200|Drug|durvalumab placebo|Matching placebo for intravenous infusion
15821838|NCT04269200|Drug|olaparib placebo|Placebo tablets to match olaparib
15821839|NCT04269200|Drug|Carboplatin|Standard of care chemotherapy
15821840|NCT04269200|Drug|Paclitaxel|Standard of care chemotherapy
15821841|NCT04269187|Drug|Theophylline|Theophylline oral 200 mg daily for 12 days
15821843|NCT04269148|Other|Measurement of Quality of Life|Quality of life will be measured using McMaster University Head and Neck Radiotherapy Questionnaire and The Functional Assessment of Cancer Therapy - Head and Neck Cancer Version 4
15821844|NCT04269122|Other|No Intervention|No intervention
15821845|NCT04269109|Other|Multi-modal Opioid Sparing Pain Management Protocol|Incorporating multimodal opioid sparing ERAS techniques for cardiac surgery patients should show a decrease in the amount of opioids received, reduction in incidence of chronic pain, ileus, delirium, and potential for opioid addiction post-operatively. Between the dates of November 2018 through February 2019, a multi-modal, opioid sparing pain management protocol was evolving and a protocol was put into place. This study will compare outcomes before and after implementation of the protocol between the dates of September 1, 2018 - October 31, 2018 and March 1, 2019 - April 30, 2019.
15821846|NCT04269096|Other|Protocol Compliance|Compliance with the Prisma Health-Upstate Laparoscopic Cholecystectomy Perioperative Protocol
15821847|NCT04269083|Other|BIRC3|BIRC3-expression directed preoperative chemoradiotherapy in patients with resectable adenocarcinoma of the esophagus and EGJ
15821848|NCT04269070|Behavioral|Standing condition|Participants will be asked to stand an additional 6 minutes per hour above their median standing time from the observed time in the usual behavior condition.
15821849|NCT04269070|Behavioral|Light physical activity (LPA) condition|Participants will be asked to perform 6 additional minutes per hour above their median LPA time from the observed time in the usual behavior condition.
15821850|NCT04269070|Behavioral|Usual behavior condition|Participants will be asked to perform their normal work activities in their normal work environment for one week. There will be no modifications to their work environment or instructions given of what activities to partake in. This period will be used to understand their normal standing and LPA behaviors to determine the personalized changes to their standing and LPA behaviors in the other conditions.
15821851|NCT04269044|Diagnostic Test|non-contact EKG|ultra-sensitive, non-contact EKG pad will be placed beneath the infant
15821852|NCT04269031|Drug|AZD2373 subcutaneous injection|Randomised subjects will receive a single ascending dose of AZD2373 by SC injection (dose 1, dose 2, dose 3, dose 4, dose 5 and dose 6).
15821853|NCT04269031|Drug|Placebo|Randomised subjects will receive a single ascending dose of placebo (saline solution) by SC injection.
15821854|NCT04269018|Behavioral|Cancer specific Mobile text message|The intervention is cancer specific lifestyle mobile text messages daily for 2 months
15821855|NCT04269018|Behavioral|General health messages|Daily text related with general health message
15821856|NCT04269005|Other|Implementation of the SCCM|Implementation of the SCCM includes a baseline survey, assessment of screening questions stage 1 (with consequence), screening questions stage 2 (with consequence) and if necessary psychosomatic-psychiatric consultation and liaison service including if applicable post hospital intervention and a follow-up survey in a distressed focus sample.
15821857|NCT04268992|Other|Long-term exercise|All patients randomised to long-term exercise will perform exercise training at least three times a week for three months. The exercise is supervised and individualised.
15821858|NCT04268979|Behavioral|eSNAP|eSNAP is a web based tool that quickly collects and organizes social support information entered by Family Caregivers (FCGs) into visualizations of the size, quality, and function of support networks. Visualizations can help FCGs catalogue support resources and present them in a new way, which may make them more salient and remind FCGs of their availability.
15821859|NCT04268979|Behavioral|Caregiver Navigator|The Caregiver Navigator will have social work training and will help Family Caregivers (FCGs) identify and leverage informal and formal social support, including enrolling or directing FCGs to services.
15821860|NCT04268966|Drug|Brincidofovir|
15821861|NCT04268953|Drug|Tricaprilin|Tricaprilin formulated as AC-SD-03 mixed in 300mL water
15821862|NCT04268940|Diagnostic Test|Thromboelastography|Thromboelastography (TEG 6s, global hemostasis cartridge) will be performed before ECMO insertion and at different time-points during the course of ECMO. In parallel a full coagulation work-up (aPTT, prothrombin time [PT], anti-Xa, activated clotting time[ACT], platelets count, d-dimers, von Willebrand panel and fibrinogen) will be measured simultaneously with each TEG.
15821886|NCT04268771|Biological|Arm B: Rituxan®/Mabthera®|Reference product US- rituximab (Rituxan®) or EU-rituximab (MabThera®), 100mg or 500mg, concentrate for solution for infusion
15821887|NCT04268758|Device|tulipon|Tulipon is a new kind of hygienic device, used to collect the secreted menses during the bleeding phase of the menstruation.
15821863|NCT04268927|Drug|GnRH ant/letrozole|"Letrozole (Femara; Novertis pharma AG, Basle, Switzerland) is administered starting on cycle day one for 8 consecutive days . The dose of letrozole is 5mg /day during the first 5 days of cycle and 2.5 mg/day during the subsequent 3 days .
~Highly purified urinary FSH (HP-uFSH) (Fostimon, IBSA) 300 IU/day is started on cycle day 5 and is continued until and including the day of HCG administration. Starting from cycle day 8 , the dose of HP-uFSH is adjusted individually according to ovarian response which is monitored using transvaginal ultrasound and serum estradiol.
~GnRH antagonist (cetrorelix acetate)(Cetrotide®) 0.25 mg S.C once daily is started when the leading follicle is 14 mm in mean diameter and is continued until and including the day of HCG administration ."
15821864|NCT04268927|Drug|GnRH ant|"Highly purified urinary FSH (HP-uFSH) (Fostimon, IBSA) 300 IU/day is started on cycle day 5 and is continued until and including the day of HCG administration. Starting from cycle day 8 , the dose of HP-uFSH is adjusted individually according to ovarian response which is monitored using transvaginal ultrasound and serum estradiol.
~GnRH antagonist (cetrorelix acetate)(Cetrotide®) 0.25 mg S.C once daily is started when the leading follicle is 14 mm in mean diameter and is continued until and including the day of HCG administration ."
15821865|NCT04268914|Device|Oculus Go VR|The Oculus Go is a standalone headset with built-in speakers that runs independently of a smartphone. Via the Oculus Go, participants will engage with BearBlast (developed by AppliedVR). Throughout the world, plush moles play the role of antagonist, standing in for the nuisance and distraction of pain. The VR game is equipped with a head-tracking system, enabling the player to look around the virtual environment. In addition, there is the option to interact with the VR environment using a tap pad located on the side of the helmet. Therefore, the child will be receiving distraction via 3-D visual and auditory sensory, and tactile feedback, thus supplying a multi-sensory immersive experience. The VR HMD runs independently of a smartphone and has active matrix LCDs with high pixel resolution, creating a bright, vibrant color and a quality image.
15821866|NCT04268914|Device|Mira Prism VR|The Mira Prism is a portable, augmented reality (AR) HMD powered by iPhone. When paired with the iPhone, the Mira Prism goggles can superimpose computer-generated images on the user's view of the real world. Unlike the full immersion of VR, AR allows users to view the outside world while interacting with digital content. In this study, the patient will interact with Magic Mallet (developed by Miney Moe) until falling asleep during the anesthesia induction process. Magic Mallet is a distraction game designed for pain management and communication during procedures. The game automatically adjusts cognitive load for optimal effect for users. Study team iPhones specifically loaded with Magic Mallet, and without cellular capability, will be used with the Mira Prism.
15821867|NCT04268901|Device|Samsung Gear VR|Participants 13 -21 years old can use the Samsung Gear VR. The VE to be used in this study is mobile based (Samsung with the Gear VR) and has active matrix LCDs with high pixel resolution, creating a bright, vibrant color and a quality image. The VR game is equipped with a head-tracking system, enabling the player to look around the virtual environment. In addition, there is the option to interact with the VR environment using a tap pad located on the side of the helmet. Therefore, the child will be receiving distraction via 3-D visual and auditory sensory, and tactile feedback, thus supplying a multi-sensory immersive experience. While wearing these glasses, the children only can see the HMD screen so that the immersion and presence will be increased. The VR glasses will be sanitized before every use so that the chance of infection will be minimized.
15821868|NCT04268901|Device|Merge VR|Participants 10-21 years can use the Merge. The VE to be used in this study is mobile based (Pixel with the Merge) and has active matrix LCDs with high pixel resolution, creating a bright, vibrant color and a quality image. The VR game is equipped with a head-tracking system, enabling the player to look around the virtual environment. In addition, there is the option to interact with the VR environment using a tap pad located on the side of the helmet. Therefore, the child will be receiving distraction via 3-D visual and auditory sensory, and tactile feedback, thus supplying a multi-sensory immersive experience. While wearing these glasses, the children only can see the HMD screen so that the immersion and presence will be increased. The VR glasses will be sanitized before every use so that the chance of infection will be minimized.
15821869|NCT04268901|Device|Oculus Go|Participants 7-21 years can use the Oculus Go. The visual a bright, vibrant color and a quality image. The VR game is equipped with a head-tracking system, enabling the player to look around the virtual environment. In addition, there is the option to interact with the VR environment using a handheld remote. Therefore, the child will be receiving distraction via 3-D visual and auditory sensory, and tactile feedback, thus supplying a multi-sensory immersive experience. While wearing these glasses, the children only can see the HMD screen so that the immersion and presence will be increased. The VR glasses will be sanitized before every use so that the chance of infection will be minimized.
15821870|NCT04268888|Drug|Nivolumab and TACE/TAE|Immunotherapy and TACE/TAE
15821871|NCT04268888|Procedure|TACE/TAE|TACE/TAE (as per local practice)
15821872|NCT04268875|Device|Optical Coherence Tomography (OCT)|"The OCT fibre is an optical fibre catheter containing a lens located at its extremity and positioned distal to the arterial segment to be examined. This is an intracoronary, very high-resolution section technique based on absorption and reflection of close infrared light by stents and tissues.
~OCT analysis is performed during a usual coronary angiography procedure. It is a common technique already used and recommended for intrastent restenosis to establish the mechanism of the process. No new product is being tested. The examination performed is the same."
15821873|NCT04268849|Drug|Ferumoxytol|Ferumoxytol (30 mg/mL) intravenous injection in single use vials.
15821874|NCT04268849|Drug|Saline|Placebo for Ferumoxytol
15821875|NCT04268849|Drug|Ferrous sulfate tablets|ferrous sulfate tablets containing 60 mg elemental iron
15821876|NCT04268849|Drug|Vitamin C|Placebo: Vitamin C, 250 mg, given in the same bottle as the oral iron
15821877|NCT04268836|Device|Optimal Acuity Clear-K® Low Vision Aid System treatment|The treatment involves irradiation of the cornea with low energy light in a treatment pattern that produces corneal shape change.
15821880|NCT04268810|Procedure|Bladder instillations|bladder instillations with either solution (DMSO or Uracyst)
15821881|NCT04268797|Device|HR rTMS|high frequency repetitive transcranial magnetic stimulation (HF rTMS) with H7-coil applied once daily during the twenty days
15821882|NCT04268797|Device|sham|SHAM HF rTMS coil once daily x 20 days
15821883|NCT04268784|Drug|DNL343|Single and repeating oral dose(s)
15821889|NCT04268745|Behavioral|Traditional Vestibular Rehabilitation|Progressive balance training and gaze stability exercises
15821890|NCT04268719|Diagnostic Test|wireless pH capsule recording|wireless pH capsule recording for up to 96 hours
15821891|NCT04268706|Drug|CD30.CAR-T|Autologous CD30.CAR-T cells infused on Day 0 after the completion of lymphodepleting chemotherapy.
15821892|NCT04268706|Drug|Fludarabine|Lymphodepletion chemotherapy (30 mg/m2/day) for 3 consecutive days
15821893|NCT04268706|Drug|Bendamustine|Lymphodepletion chemotherapy (70 mg/m2/day) for 3 consecutive days
15821895|NCT04268667|Other|Spinal manipulation|Application of upper cervical spine thrust joint manipulation or application of a full combination of cervical, cervico-thoracic and thoracic spine thrust joint manipulation.
15821896|NCT04268654|Procedure|Preoperative Arterial Embolization|"PAE will be performed by arteriographic procedure before esophageal resection surgery minimum 14 days before surgery.
~An angiogram of the celiac trunk is performed through a femoral access before and after the embolization. Embolization by coils of the left gastric artery, splenic artery and the right gastric artery is realized."
15821897|NCT04268641|Other|Arm 1|"Materials used for the course :
~: Standard Wheelchair
~: Standard Wheelchair + Seat back + Positioning cushion
~: Standard Wheelchair + Seat back + Positioning cushion + Belt"
15821898|NCT04268641|Other|Arm 2|"Materials used for the course :
~: Standard Wheelchair
~: Standard Wheelchair + Seat back + Positioning cushion + Belt
~: Standard Wheelchair + Seat back + Positioning cushion"
15821899|NCT04268641|Other|Arm 3|"Materials used for the course :
~: Standard Wheelchair + Seat back + Positioning cushion
~: Standard Wheelchair + Seat back + Positioning cushion + Belt
~: Standard Wheelchair"
15821900|NCT04268641|Other|Arm 4|"Materials used for the course :
~: Standard Wheelchair + Seat back + Positioning cushion
~: Standard Wheelchair
~: Standard Wheelchair + Seat back + Positioning cushion + Belt"
15821901|NCT04268641|Other|Arm 5|"Materials used for the course :
~: Standard Wheelchair + Seat back + Positioning cushion + Belt
~: Standard Wheelchair
~: Standard Wheelchair + Seat back + Positioning cushion"
15821902|NCT04268641|Other|Arm 6|"Materials used for the course :
~: Standard Wheelchair + Seat back + Positioning cushion + Belt
~: Standard Wheelchair + Seat back + Positioning cushion
~: Standard Wheelchair"
15821903|NCT04268628|Other|Serum and plasma samples analysis|This is a non-interventional study and no drug will be given as part of this study. Serum and plasma samples will be collected from the participants with metastatic castration-resistant prostate cancer to evaluate genetic polymorphism and pharmacodynamic parameters.
15821904|NCT04268615|Other|Covert Saccades and Virtual Reality|During this intervention, patients will undergo head impulse testing while wearing virtual reality Headsets. During the head impulse tests the visual information will be modified in order to create a conflict between head rotation and rotation of the visual scene. Recording of head and eye movement will be done during these head impulses in order to verify if visual information modifies compensatory eye movements during head impulses.
15821905|NCT04268615|Other|Actives versus passives Head Impulses|Patients will undergo classic passive head rotation as well as active head rotation in order to compare latencies of covert saccades in both conditions.
15821906|NCT04268615|Other|Visually guided saccades|Patients as well as healthy control subjects will undergo testing of visually guided saccades in different conditions (step, gap, overlap) in order to compare latencies of covert saccades between both groups.
15821907|NCT04268602|Other|local anesthetic injection|1% lidocaine
15821908|NCT04268589|Other|virtual reality game|routine
15821909|NCT04268563|Drug|placebo|Oral rehydration solution
15821910|NCT04268563|Drug|metformin|metformin tablet
15821911|NCT04268563|Drug|Sitagliptin|Sitagliptin tablet
15821912|NCT04268563|Drug|Sitagliptin/metformin|Sitagliptin/metformin tablet
15821913|NCT04268550|Drug|Selpercatinib|Given PO
15821914|NCT04268537|Drug|PD-1 blocking antibody+standard treatment|After randomization, PD-1 blocking antibody 200mg iv, one time. Standard treatment is according to the protocol of treatment of 2019-nCoV infection
15821915|NCT04268537|Drug|Thymosin+standard treatment|Thymosin 1.6 mg sc qd, last for 5 days. Standard treatment is according to the protocol of treatment of 2019-nCoV infection
15821916|NCT04268537|Other|standard treatment|Standard treatment is according to the protocol of treatment of 2019-nCoV infection
15821917|NCT04268524|Combination Product|drug: miltefosine with thermotherapy|see previous
15821918|NCT04268511|Procedure|Caudal epidural block group|The linear probe of ultrasound was then rotated 90 degrees and placed longitudinally in the midline to evaluate the sacral cornus, sacrococcygeal ligament and sacral bone. A 22 Gauge 50 mm echogenic block needle was advanced
15821919|NCT04268511|Procedure|Pudendal nerve block group|A 22 Gauge 50 mm insulated needle was then introduced in the anterior-posterior direction at the middle of the ultrasound probe's superior edge with an out-of-plane approach and using an inclination of 15° in the sagittal plane. The needle tip's position was identified by direct visualization using the movement of adjacent anatomical structures.
15821920|NCT04268498|Drug|Bortezomib|1.3 mg/m2 administered Subcutaneous (SC) or intravenous (IV) on days 1, 4, 8 and 11 of a 21 day treatment cycle for participants randomized to Arm A.
15821921|NCT04268498|Drug|Dexamethasone|"20 mg or 40 mg per dose administered by mouth (PO) or IV.
~Participants randomized in Arm A:
~20 mg/dose on days 1, 4, 8 and 11 on a 21 day treatment cycle;
~Participants randomized in Arm B:
~Cycles 1 through 4 - 40mg/dose on days 1, 8 and 15 on a 28 day cycle; Cycles 5 through 8 - 20mg/dose on days 1, 8, 15 on a 28 day cycle
~Participants randomized in Arm C:
~Cycle 1 - 20 mg/dose on days 1, 2, and 22, and 40mg/dose on days 8 and 15 on a 28 day cycle; Cycle 2 - 40 mg/dose on days 1, 8, and 15 and 20mg/dose o day 22 on a 28 day cycle; Cycles 3-4 - 40mg/dose on Days 1, 8, 15 on a 28 day cycle; Cycles 5-8 - 20mg/dose on days 1, 8, 15 on a 28 day cycle"
15821922|NCT04268498|Drug|Lenalidomide|"10 or 25 mg/day capsules administered PO.
~Participants randomized in Arm A:
~25 mg/day capsules on Days 1 through 14 of a 21 day cycle.;
~Participants randomized in Arm B:
~Cycles 1 through 8 - 25 mg/day capsules on Days 1 through 21 of a 28 day cycle;
~Participants randomized in Arm C:
~Cycles 1 - 25 mg/day capsules on Days 2 through 21 of a 28 day cycle; Cycles 2 through 8 - 25 mg/day capsules on Days 1 through 21 of a 28 day cycle;
~Maintenance Therapy:
~10 mg capsules on Days 1 through 21 on a 28 days cycle."
15821923|NCT04268498|Drug|Acetaminophen|"650 mg administered PO.
~Participants randomized to Arm C:
~Cycles 1 through 8 - 650 mg administered on Days 1, 8 and 15."
15821924|NCT04268498|Drug|Diphenhydramine|"25 mg administered via IV
~Participants randomized to Arm C:
~Cycles 1 through 8 - 25 mg administered on Days 1, 8 and 15."
15821925|NCT04268498|Drug|Montelukast|10 mg administered PO to participants randomized to Arm C prior to the first 4 doses of Daratumumab.
15821926|NCT04268498|Drug|Carfilzomib|"20 mg or 56 mg/m2 per dose administered via IV.
~Participants randomized to Arm B:
~Cycle 1 - 20 mg/m2 per dose on Day 1 and 56 mg/m2 per dose on days 8 and 15 of a 28 day cycle; Cycles 2 through 8 - 56 mg/m2 per dose on days 1, 8 and 15 of a 28 day cycle;
~Participants randomized to Arm C:
~Cycle 1 - 20 mg/m2 per dose on Day 2 and 56 mg/m2 per dose on days 8 and 15 of a 28 day cycle; Cycles 2 through 8 - 56 mg/m2 per dose on days 1, 8 and 15 of a 28 day cycle"
15821927|NCT04268498|Drug|Daratumumab|"16 mg/kg administered via IV or 1800 mg SC, per treating physician discretion.
~Participants randomized to Arm C:
~Cycles 1 though 2 - 16 mg/kg IV or 1800 mg SC on days 1, 8, 15, and 22 of a 28 day cycle; Cycles 3 through 6- 16 mg/kg IV or 1800 mg SC on days 1 and 15 of a 28 day cycle; Cycles 7 through 8 - 16 mg/kg IV or 1800 mg SC on day 1 of a 28 day cycle"
15821928|NCT04268498|Biological|Autologous Stem Cell Transplant (ASCT)|Participants who are MRD positive at the conclusion of 8 cycles of study treatment, and were able to have their stem cells that were extracted, will receive ASCT from participants' bone marrow samples.
15821929|NCT04268485|Diagnostic Test|Serum KL-6 level|Serum blood biomarker which has been shown to be of interest in idiopathic pulmonary fibrosis
15821930|NCT04268472|Drug|GP30101|Single oral dose 800 mg, administered in a fed condition, co-administered with low dose ritonavir as a pharmacokinetic enhancer
15821931|NCT04268472|Drug|Prezista®|Single oral dose 800 mg, administered in a fed condition, co-administered with low dose ritonavir as a pharmacokinetic enhancer
15821932|NCT04268472|Drug|GP30101|Single oral dose 800 mg, administered in a fed condition, co-administered with low dose ritonavir as a pharmacokinetic enhancer
15821933|NCT04268472|Drug|Prezista®|Single oral dose 800 mg, administered in a fed condition, co-administered with low dose ritonavir as a pharmacokinetic enhancer
15821934|NCT04268459|Device|Provox prosthesis exchange|Each patient post laryngectomy will be randomly assigned to one arm of intervention. The voice prosthesis exchange in all patients will be performed in local anaesthesia. The microbiological samples with cotton swabs will be collected from tracheoesophageal fistula on prosthesis exchange. The clinical evaluation and patients satisfaction from prosthesis usage will be performed on each exchange.
15821935|NCT04268433|Other|N/A - Non-interventional study|"Stages:
~Patient information and written informed consent (3 Copies. To be carried out >24 hours after receiving the patient information sheet)
~Physiological recording set up (ECG, BP, sensor and respiratory band)
~Control period - no music played
~Series of pieces of music without tempo control
~Repeat series of pieces of music with tempo control
~Participant leaves the study"
15821936|NCT04268420|Drug|FMP013|Falciparum Malaria Protein-13
15821937|NCT04268420|Drug|ALFQ|ALF with QS-21, saponin molecule derived from the tree bark of Quillaja species
15821938|NCT04268407|Drug|Amoxicillin Clavulanate|compare the duration of antbiotic use: 2 day versus 7 day
15821939|NCT04268394|Drug|CC-99677|CC-99677
15821940|NCT04268394|Drug|Methotrexate|Methotrexate
15821941|NCT04268394|Drug|Sulfasalazine|Sulfasalazine
15821942|NCT04268394|Drug|Itraconazole|Itraconazole
15821943|NCT04268394|Drug|Rifampin|Rifampin
15821944|NCT04268394|Drug|Midazolam|Midazolam
15821945|NCT04268394|Drug|Digoxin|Digoxin
15821946|NCT04268394|Drug|Metformin|Metformin
15821947|NCT04268394|Drug|Rosuvastatin|Rosuvastatin
15821948|NCT04268381|Other|Biochemical analysis|aMMP-8 is measured by immunofluorometric assay (IFMA).
15821949|NCT04268355|Behavioral|Mindfulness Training for Primary Care|MTPC is a referral-based, insurance-reimbursable 8-week program delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action plan during Week 7. Participants are called every two weeks for the first eight weeks for 5-10 minute engagement calls which focus helping participants cultivate a relationship with study staff, giving participants a place to ask questions, and supporting participants in completing study visits.
15821950|NCT04268342|Other|Resistance guided treatment for gonorrhoea infection|For cases of gonorrhoea infection treated at the return visit, a nucleic acid assay will be used to determine individual eligibility for ciprofloxacin treatment
15821951|NCT04268329|Other|Educational website|A website is used to educate patients and family members about head and neck cancer.
15821952|NCT04268316|Device|Virtual Reality Behavioral Activation|"Participants will choose four activities to complete in virtual reality over the course of the week. These activities are video 360 and range from viewing animals, to viewing nature scenes, to traveling to a different location in the world, to viewing adrenaline-pumping activities."
15821953|NCT04268316|Behavioral|Behavioral Activation in real-life|Participants will choose four pleasurable and/or mastery activities to complete over the course of the week in real life.
15821954|NCT04268303|Drug|Sublingual film containing dexmedetomidine (BXCL501)|Sublingual film containing dexmedetomidine (BXCL501)
15821955|NCT04268303|Drug|Placebo Film|Placebo Film for BXCL501
15821956|NCT04268290|Combination Product|Single incision plus one port laparoscopic surgery|SILS plus one port surgery and enhanced recovery after surgery protocol both are methods taking the minimally invasive benefits for the patients including faster recovery, reduced postoperative pain and shorter hospital stay.
15821957|NCT04268277|Drug|Rituximab|100 mg concentrate for solution for infusion
15821958|NCT04268277|Drug|Pembrolizumab|100 mg/ 4mL concentrate for solution for infusion
15821959|NCT04268264|Procedure|Incremental haemodialysis|twice weekly haemodilysis at the start, gradually building up to full dose dialysis over a period of 15 weeks
15821960|NCT04268264|Procedure|Conventional haemodialysis|three times weekly 4-hour long haemodialysis sessions from the start
15821961|NCT04268251|Diagnostic Test|MRI with deep learning based denoising|1-mm coronal contrast-enhanced T1 weighted image with deep learning based denoising
15821962|NCT04268238|Procedure|Hygiene Guidance|Two weeks before the start of the study, the volunteers will go through a wash out period, where they should only use oral care products donated by the researchers, which should be used until the end of the study. The oral hygiene kit will contain 1 toothbrush (Professional Lab Series, Colgate Palmolive), 1 toothpaste without desensitizing agent, but with fluorine (Elmex) and 1 dental floss (Colgate).
15821963|NCT04268238|Procedure|Sealant Application|Permaseal (Ultradent) is an unloaded resin based on methacrylate and photopolymerizable. The teeth that will be sealed will be isolated. 35% phosphoric acid will be applied for 20 seconds and then it will be necessary to wash and dry the tooth surface. Apply a thin layer of PermaSeal for 5 seconds to the tooth surface and light curing for 20 seconds. After that, it is necessary to evaluate occlusion.
15821964|NCT04268238|Radiation|Low Level Laser Application|Volunteers will receive irradiation with AsGaAl laser, wavelength of 780nm (Laser XT Therapy, DMC, São Carlos, SP) with fixed power of 100mW, density of energy of 35 J/cm2 (considering a spot size of 0.028cm2 of this equipment), the dose will be 1 J per point. Irradiation will be performed at a cervical, an apical point, and another point exactly on the injury, totaling a dose of 3J. Treatment should be performed in 3 sessions with an ideal 72-hour interval between them.
15821965|NCT04268225|Procedure|US guided dynamic needle tip positioning peripheral intravenous cannulation|Catheterizations will be performed by one of three pediatric intensivists with vast experience in both traditional and US guided DNTP techniques for peripheral intravenous access. The operator will be allowed to independently choose which peripheral vein to cannulate. If necessary, patients will be given supplemental dose of sedation and analgesia in addition to the already given continuous infusions for invasive mechanical ventilation. Before puncture, the limb will be taped and maintained in an optimal position. A tourniquet will be placed proximal to the planned cannulation site. The site of puncture will be disinfected with Chlorhexidine gluconate 0.5% w/v, Alcohol 70% v/v. The choice of catheter will be left to the discretion of the operator. Available PIV cannulas include : 14 GA, 2X45 mm; 17 GA, 1.4X45 mm; 18 GA 1.2X45 mm; 20 GA 1X32mm BD Venflon™ and 24 GA, 0.7X19 mm; 26 GA 0.6X19 mm BD Neoflon™ (Becton Dickinson Infusion Therapy AB, Helsingborg, Sweden).
15821966|NCT04268225|Procedure|Traditional peripheral intravenous cannulation|For traditional insertion technique insertion attempt will be blind or tactile.
15821967|NCT04268212|Dietary Supplement|Bitter melon juice (100 ml)|Fresh bitter melon fruits were purchased from certified local groceries. The seeds of bitter melon were removed, and the juice was obtained from the raw fruit using a blender. Every 140 g of bitter melon fruit produced approximately 100 ml bitter melon juice.
15821968|NCT04268212|Behavioral|Exercise|The walking exercise was started 15 minutes after the glucose load. Walking speed was determined to elicit 65% of the maximum heart rate (HRmax) during exercise for each participant. HRmax was estimated using the America College of Cardiology prediction model, HRmax=208 - 0.7 × age. All participants wore a heart rate monitor (Polar, Vantage, XL) around the chest to assess exercise intensity. A rate of perceived exertion was assessed every 2 minutes based on the Borg's scale.
15821969|NCT04268199|Drug|Bortezomib Injection|Subcutaneous injection
15821970|NCT04268186|Device|Direct tDCS|Transcranial direct current stimulation (tDCS) will be applied. Stimulation amplitude is 2 mA. Stimulation duration is 20 minutes. The configuration used is two electrodes at AFz and CPz of the 10-10 electrode system.
15821971|NCT04268186|Device|Indirect tDCS|Transcranial direct current stimulation (tDCS) will be applied. Stimulation amplitude is 2 mA. Stimulation duration is 20 minutes. The configuration used is two electrodes at AF3 and AF4 of the 10-10 electrode system.
15821972|NCT04268186|Device|Personalized tDCS|Transcranial direct current stimulation (tDCS) will be applied. Stimulation amplitude is 2 mA. Stimulation duration is 20 minutes. The configuration used will be optimized to stimulate key nodes connected to MCC, including anterior insula, MFG and supramarginal gyrus, and designed using an individual head model that will be combined with each subject's measured connectivity map. The number of electrodes will be minimally 2 and maximally 32.
15821973|NCT04268186|Device|Sham tDCS|Transcranial direct current stimulation (tDCS) will be applied. Stimulation amplitude is 2 mA. Stimulation duration is 20 minutes. Placebo stimulation will be applied by ramping the current up and immediately down over 30 seconds. The configuration used is two electrodes at AF3 and AF4 of the 10-10 electrode system.
15821974|NCT04268173|Other|Community-Based, Client-Centered Prevention Home|Prevention Navigators at Vivent Helath offices will engage participants in risk assessments, goal planning, and treatment referrals based on their needs and desires.
15821975|NCT04268160|Diagnostic Test|Blood draw to measure GPx activity|Routine blood draw to measure levels of blood markers.
15821976|NCT04268160|Diagnostic Test|Blood draw to measure SOD activity|Routine blood draw to measure levels of blood markers.
15821977|NCT04268160|Diagnostic Test|Blood draw to measure Lp(a) levels|Routine blood draw to measure levels of blood markers.
15821978|NCT04268134|Dietary Supplement|Omega-3 fatty acid supplement|4 capsules taken by mouth each day for 24 weeks (starting at the week 12 visit).
15821979|NCT04268121|Drug|Neoadjuvant treatment|4 cycles of platinum-based chemotherapy (carboplatin or cisplatin) plus etoposide followed by surgery or chemoradiotherapy
15821980|NCT04268121|Drug|Adjuvant treatment|Surgery (before study entry) followed by 4 cycles of platinum-based chemotherapy (carboplatin or cisplatin) plus etoposide
15821981|NCT04268108|Biological|liquid tumor infiltrating lymphocytes|Isolatation and amplification PD-1+ cells from peripheral blood lymphocytes under GMP conditions for clinical use.
15821982|NCT04268095|Other|Dressing protocol|Patients are assigned with different postoperative dressing protocols.
15821983|NCT04268082|Device|Visual biofeedback with the use of sensorized insoles|Between the 4th and the 10th day post surgery, both groups performed the same rehabilitation protocol. The experimental group was re-educated to the correct gait dynamics by wearing the sensorized insoles and by using a specific software's graphical interface as a visual biofeedback.
15821984|NCT04268082|Other|Standard rehabilitation based on physiotherapist's verbal instructions|Between the 4th and the 10th day post surgery, both groups performed the same rehabilitation protocol.The Control group did not wear the insoles, but it carried out the rehabilitation programme under the physiotherapist supervision and with his verbal feedbacks.
15821985|NCT04268069|Drug|PL9643 Ophthalmic Solution|PL9643 Ophthalmic Solution as topical ophthalmic drops administered bilaterally for 12 weeks.
15821986|NCT04268069|Drug|Placebo Ophthalmic Solution|Placebo solution as topical ophthalmic drops administered bilaterally for 12 weeks.
15821987|NCT04268056|Diagnostic Test|Collection of skin culture samples|Collection of skin culture samples using a sterile swab. the swab will gently rubbed on the skin on the 3 different skin areas. The target areas are i) regions surrounding the RT treatment area (if possible, not from the scar area or from skin folds areas), ii) a control site of the normal (healthy) breast , iii) a control area on the forehead.
15821988|NCT04268043|Device|flexible laryngeal airway mask|Ventilation with flexible laryngeal mask airway
15821989|NCT04268043|Device|proseal laryngeal mask airway|Ventilation with proseal laryngeal mask airway
15821990|NCT04268030|Other|collection of LFPs|collection of local field potentials (LFPs) at rest and during hand opening and closing
15821991|NCT04268017|Device|FeetMe Monitor|"For gait parameters' evaluation, the investigator asks the participant to move in a straight line over a 10-meter mat. The participant had to start the feet in line and then start walking at a comfortable speed. During this time, the investigator records the gait parameters from the FeetMe Monitor® and Gaitrite® system.
~An operator asked the patient to repeat 3 trials. The same sequence was repeated by three other operators. The same measurement is done 7 days later.
~A questionnaire is given to assess the ergonomics of the device"
15821992|NCT04268004|Behavioral|FP Decision Tool and Discussion|The intervention will be administered by a trained interventionist. The interventionist will administer the digital FP Decision Tool to families in the intervention arm. The tool asks questions examining each AYA's thoughts or feelings regarding parenthood and fertility preservation. The parent version asks the same questions, plus additional questions asking the parent to rate their son's feelings on certain topics (i.e., whether their son wants to have a child, whether their son would be as happy with an adopted child versus a biological child). Items are coded based on the domains of the Health Belief Model (perceived benefits, perceived barriers, perceived threats, self-efficacy, and cues to action). Items are scored and the trained interventionist will facilitate a guided discussion based on the family's responses and discrepancies.
15821993|NCT04267991|Drug|Tacrolimus ointment|Patients were treated with 0.03 % tacrolimus ointment twice daily for 6 months.
15821994|NCT04267991|Procedure|phototherapeutic keratectomy|Patients underwent transepithelial PTK for subepithelial infiltrates.
15821995|NCT04267978|Drug|recombinant human endostatin,temozolomide,irinotecan|"Temozolomide was given orally 200mg/m2 for 5 days in each cycle. Day 1 TMZ was administered 3-6 hours prior to irinotecan.
~Irinotecan was administrated 125mg/m2 on day 1 and day 15. Recombinant human endostatin was administrated 15mg/d, daily for 14 days. One treatment cycle was defined as 28 days (4 weeks), even if treatment is held mid-cycle for toxicity.
~Treatment was continued until disease progression, patient withdrawal, or unacceptable toxicity.
~The maximum number of treatment cycles was 12. After 12 cycles of treatment, if the investigator judges that the subject may continue to benefit from the regimen, the duration of treatment may be extended with the subject's consent."
15821996|NCT04267965|Procedure|parathyroidectomy plus bilateral thymectomy and autotransplantation|Patients should receive total parathyroidectomy plus bilateral thymectomy and autotransplantation
15821997|NCT04267952|Behavioral|Hand hygiene intervention program developed according to planned behavior theory|The perception of the importance of hand hygiene with expression of damages of microorganisms (stories about illnesses etc.). Visually assisted hand hygiene training experiments to ensure the visibility of microorganisms in the environment. Demonstration and application of the correct hand washing technique with music. All applications will take place in three lessons (120-minute).
15821998|NCT04267952|Behavioral|Classical hand hygiene education|expression of hand hygiene with verbal presentation method in a 40-minute lecture
15822001|NCT04267926|Drug|20 mg MitoQ|a third of subject will receive 20mg of oral MitoQ
15822002|NCT04267926|Drug|Placebo|Subject will receive Placebo
15822003|NCT04267926|Drug|40mg of MitoQ|a third of subjects will receive 40mg of MitoQ
15822004|NCT04267913|Drug|Dexamethasone|Given IV
15822005|NCT04267913|Drug|Docetaxel|Given IV
15822006|NCT04267913|Biological|Ramucirumab|Given IV
15822007|NCT04267913|Drug|Sapanisertib|Given PO
15822008|NCT04267900|Drug|99mTc-HPArk2|99mTc-HPArk2 were injected into the patients before the SPECT/CT scans
15822009|NCT04267887|Drug|Abiraterone Acetate|Given PO
15822010|NCT04267887|Drug|Antiandrogen Therapy|Given ADT per standard of care
15822011|NCT04267887|Drug|Apalutamide|Given PO
15822012|NCT04267887|Drug|Prednisone|Given PO
15822013|NCT04267887|Other|Quality-of-Life Assessment|Ancillary studies
15822014|NCT04267887|Other|Questionnaire Administration|Ancillary studies
15822015|NCT04267874|Procedure|Biospecimen Collection|Undergo collection of nasal swabs, blood, urine, and stool
15822016|NCT04267874|Dietary Supplement|Nutritional Supplementation|Given black raspberry nectar PO
15822017|NCT04267874|Drug|Placebo Administration|Given PO
15822018|NCT04267874|Other|Questionnaire Administration|Ancillary studies
15822028|NCT04267835|Procedure|MIDCAB|Surgery: MIDCAB
15822029|NCT04267835|Procedure|thoracotomy OPCABG|Surgery: thoracotomy OPCABG
15822030|NCT04267822|Drug|RV521 oral tablet|Each RV521 dose is four 50 mg dry powder blend capsules, taken orally twice daily for 10 days (20 doses total; 80 capsules total)
15822031|NCT04267822|Drug|Placebo oral tablet|Each placebo dose is four capsules, taken orally twice daily for 10 days (20 doses total; 80 capsules total)
15822032|NCT04267809|Drug|Metformin Hydrochloride|Metformin 850mg and 500mg tablets are registered and licensed in Singapore. For the study, we will be sourcing the Metformin tablets from Singapore General Hospital Formulary.
15822034|NCT04267796|Other|Dietary Intervention|Receive diet recommendations from health coach or registered dietitian
15822035|NCT04267796|Other|Quality-of-Life Assessment|Ancillary studies
15822036|NCT04267796|Other|Questionnaire Administration|Ancillary studies
15822037|NCT04267796|Other|Resistance Training|Complete high-resistance circuit training sessions
15822038|NCT04267783|Diagnostic Test|Shear wave elastography|Investigate the feasibility of use of shear-wave elastography of the uterus during the third stage of labour and following placental delivery in order to predict uterine atony .
15822039|NCT04267770|Drug|Insulin (circadian)|Participant's own insulin adjusted to circadian infusion rates
15822040|NCT04267770|Drug|Insulin (flat rate)|Participant's own insulin set to flat basal rates
15822041|NCT04267757|Procedure|rectovaginal fistula repair with Martius flap|rectovaginal fistula repair with Martius flap
15822042|NCT04267744|Other|Myia Health® remote patient monitoring unblinded treatment arm|"After consenting to the study, the Myia in-home suite of devices will be provided to all recruited patients. The data flowing from the Myia platform will be available to clinicians and patients for the duration of the pilot and utilized to complete study activities.
~Device: Myia Health platform and in-home suite of devices®:
~Emfit Ballistocardiograph® Withings Connected Scale® VitalScout (VivaLink) ECG Accelerometer® Omron Blood Pressure Monitor® (Sphygmomanometer) Cradlepoint - Hotspot / Adaptor® (LTE Connection) Samsung Galaxy Tab A 8.0® (User Interface)"
15822043|NCT04267731|Dietary Supplement|VMK223|Heat killed and purified Bifidobacterium breve polysaccharide-based extract
15822044|NCT04267731|Dietary Supplement|Cellulose|Bulking agent in food production without probiotic properties
15822045|NCT04267718|Other|Application of Padua and IMPROVE Bleeding scores|Eligible patients hospitalized in centres randomized to the Experimental group will be evaluated, within 48 hours from admission to hospital, by means of the Padua predictive score and the IMPROVE Bleeding score.
15822046|NCT04267705|Other|Control|This group will receive a cup of rice 7 days/week over a 12-week period
15822047|NCT04267705|Other|Black bean|This group will receive a cup of black bean7 days/week over a 12-week period
15822048|NCT04267705|Other|Chickpea|This group will receive a cup of chick pea 7 days/week over a 12-week period
15822049|NCT04267692|Other|HaRTC|HaRT-C participants will attend 8, virtual, adapted, low-barrier, weekly, closed-group Talking Circles-- named Harm Reduction Treatment Circles or HaRTC -- lasting approximately 2 hours each. During the HaRTC, the circle keeper will present the day's harm reduction topic, smudge the space, and allow participants to open themselves up to the circle. Topics presented by the Circle Keeper focus on harm-reduction and improving overall quality of health. Abstinence from alcohol use is not a requirement. We will not limit participants' access to treatment or services in either arm.
15822050|NCT04267679|Drug|Cannabidiol|25 mg full-spectrum CBD soft gel capsules
15822051|NCT04267666|Device|incentive spirometer|Patient had to produce a high inspiratory pressure. The ball serves as visible feedback of the inspiratory flow and indicates the obtained flow on a calibrated scale on the transparent cylinder of the spirometer. If the patient flows greater than 300 milliliters per second, the float ball in first chamber will rise. As patient flow increases to 600 milliliters per second the second ball float will rise. If the patient flow exceeds 900 milliliters per second all three will be suspended. Patient should encourage holding the balls up for a few seconds
15822052|NCT04267666|Other|Inspiratory muscle trainer device|The threshold trainer is a small plastic handheld device supplied by respironics. It includes a mouthpiece and a calibrated spring loaded valve. The valve controls a constant inspiratory pressure training load and the patient must generate the inspiratory pressure in order for the inspiratory valve to be opened and allow inhalation of air.
15822053|NCT04267653|Drug|Lactoferrin Bovine|treatment for 30 days
15822054|NCT04267653|Drug|Ferrous Sulfate|treatment for 30 days
15822055|NCT04267640|Biological|AMG0001|AMG0001 is a DNA Plasmid encoding hepatocyte growth factor (HGF) administered intramuscularly
15822056|NCT04267640|Biological|Placebo|Matching placebo
15822057|NCT04267627|Behavioral|Comprehensive Assistance: Rural Interventions, Nursing, and Guidance (CARING)|Cancer-related distress will be assessed using the NCCN Distress Thermometer amended to include HNC-specific areas of distress. For those participants experiencing high rates of distress, the nurse will provide targeted distress education. Education for participants exhibiting successful distress self-management, or with distress that has already resolved will focus on reinforcing surveillance and health promotion information contained in the Survivorship Care Plan. When indicated, the nurse will discuss potential referrals to support services with the patient, and they will decide jointly which referrals will be beneficial. Following the visits, the nurse will make agreed upon referrals using existing cancer center pathways, documenting these in the medical record. The nurse will follow-up with the patient via telephone 6 weeks following the telemedicine visit to determine uptake of the referral, documenting all referral information in the electronic medical record.
15822058|NCT04267614|Drug|Etanercept|Patients who received etanercept for RA
15822059|NCT04267601|Drug|Anagliptin|Anagliptin treatment for 24weeks
15822060|NCT04267588|Other|Navio Mobile App|Participants will use the Navio Mobile App to track participants' pain and pain treatment
15822061|NCT04267575|Device|Canady Helios Cold Plasma Scalpel|Device used to distribute cold plasma energy at the resected tumor margins.
15822063|NCT04267549|Drug|sintilimab|sintilimab is checkpoint inhibitor via blocking PD-1 (programmed cell death-1) site of signaling.
15822064|NCT04267549|Drug|apatinib|a multi-target anti-angiogenic tyrosine kinase inhibitor (TKI)
15822065|NCT04267549|Drug|S1|S-1 is an oral fluoropyrimidine consisting of tegafur (a prodrug that is converted to fluorouracil, mainly in liver microsomes but also in tumour tissue), gimeracil (an inhibitor of dihydropyrimidine dehydrogenase, which degrades 5-FU), and oteracil (which inhibits the phosphorylation of 5-FU in the gastrointestinal tract, thereby reducing the toxic effects of 5-FU in the intestinum).
15822066|NCT04267549|Drug|Nab paclitaxel|Nab paclitaxel is a albumin-bound well tolerated paclitaxel than traditional paclitaxel
15822067|NCT04267523|Behavioral|Web parenting intervention|Parents participate in the self-delivered web-based parenting intervention for 6 modules. Treatment includes abilities of psychological flexibility (to be open, aware and active), emotion regulation, and positive parenting strategies.
15822068|NCT04267523|Behavioral|Group parenting intervention|Parents participate in face-to-face a weekly 2-hour group for 4 sessions. Treatment includes abilities of psychological flexibility (to be open, aware and active), emotion regulation, and positive parenting strategies.
15822069|NCT04267497|Drug|Amphotericin B Liposomal 50 MG|Amphotericin B 50 mg powder for infusion diluted in 12 ml of sterile water. It will be administered by nebulized route 25 mg (6 ml), 3 times a week, for 6 weeks.
15822070|NCT04267497|Other|Placebo|Sterile water for injection. It will be administered by nebulized route: 6 ml, 3 times a week for 6 weeks.
15822071|NCT04267484|Device|GPS and travel diary|WP1: GPS tracker for 2 weeks and a daily diary about activity (travel diary).
15822072|NCT04267484|Other|e-decision support platform|WP2 and WP3: An e-decision support platform that will foster shared decision making about options to stay safe at home for the older adult.
15822073|NCT04267471|Behavioral|Tai Chi|Tai Chi is a traditional Chinese mind-body exercise, which combines deep-breath relaxation and gentle movements in sequence with meditation. Each session of Tai Chi will last 60 minutes, including a 10-minute warm-up, a 40-minute Tai Chi practice and a 10-minute cool-down.
15822074|NCT04267471|Behavioral|Walking|Each session of walking will last 60 minutes, including a 10-minute warm-up, a 40-minute walking and a 10-minutes cool-down.
15822075|NCT04267458|Other|evaluation of sofuspovir containing DAA regien expected insult on kidney|to use different kidney biomarkers to evaluate acute kidney damage after using sofuspovir containing DAA regimen in treatment of HCV
15822076|NCT04267445|Procedure|Embolization of prostatic artery under ultrasound guidance|Ekobi Embolization MIcrospheres is administered via selective angiography and Prostatic Artery Embolization (PAE), a minimally invasive technique for reducing symptoms from Benign Prostatic Hyperplasia (BPH) to achieve near stasis in the target vasculature. Contrast Enhanced Ultrasound (CEU) and angiographic runs will be used to confirm anatomy at the time of embolization.
15822077|NCT04267432|Dietary Supplement|Placebo|Blank
15822078|NCT04267432|Dietary Supplement|TCI633|Probiotics
15822079|NCT04267432|Drug|Type 2 collagen|Positive control group
15822080|NCT04267419|Diagnostic Test|salivary biomarker|MDA and NO as salivary biomarkers
15822083|NCT04267367|Behavioral|Dietitian-led dietary approach to management of diabetes|In the intervention phase, the educational and diet plan package will be developed. All the intervention packages will be approved by a multi-disciplinary expert team comprising an endocrinologist and dietitian prior to the intervention. Patients in the usual care arm will receive routine care as to how he/she is practicing in their daily life. Routine care includes general knowledge on diabetes disease process, blood glucose monitoring, a healthy lifestyle, preventing treating diabetes complications and developing personalized strategies for the decision-making process[27]. The intervention package will include mainly two-phase, nutritional counseling emphasis on lifestyle modification of diabetes patients and individual basis diet plan for each T2DM patients for intervention arm. The nutrition education and counseling and individual diet plan will be applied by trained dietitians.
15822084|NCT04267354|Other|Arm cycling|The arm cycle will be placed on table with height adjusted to be the same as the acromion (highest point on shoulder). Participants will start arm cycling at a low intensity and increase as per tolerance. They will exercise for a maximum of two minutes at a time, followed by a rest period for 30 seconds. In this manner 5 cycles of exercise and rest will be performed. The exercise sessions are anticipated to last a maximum of 20 minutes, depending on the patient's abilities.
15822085|NCT04267341|Other|Timed Up and Go Test|It requires individual to stand up from an armed chair, walk 3m, turn around, walk back to the armed chair, and sit down again
15822086|NCT04267341|Other|10 Meter Walk Test|10 Meter Walk Test measures the time required to complete straight walk of 10 meters distance
15822087|NCT04267341|Other|Purdue Pegboard Test|Purdue Pegboard test evaluates the fine manuel dexterity
15822088|NCT04267328|Procedure|Elective Orthopedic Surgery|Patients having knee (unilateral primary osteoarthritis or bilateral primary osteoarthritis) surgery, hip (unilateral primary osteoarthritis or bilateral primary osteoarthritis) or shoulder (primary osteoarthritis) elective surgery.
15822089|NCT04267315|Procedure|Trigger point injection|1mL injections of 1% lidocaine in the muscles identified active trigger points at the day of intervention (pectoralis major, serratus anterior, levator scapulae, latissimus dorsi, infraspinatus).
15822090|NCT04267315|Procedure|Subcutaneous saline injection|0.2mL subcutaneous saline injections superficial to the muscles identified with active trigger points at the day of intervention (pectoralis major, serratus anterior, levator scapulae, latissimus dorsi, infraspinatus).
15822091|NCT04267315|Other|Comprehensive Rehabilitation program|Patients in both groups will undergo a comprehensive rehabilitation program, which may include Physical Therapy, Occupational Therapy, Exercise Physiologist, Rehabilitation Nurse, Psychologist, as per Physiatrist's prescription. Both the comprehensive rehabilitation program and pain medications will continue to be managed by participant's Physiatrist, who will be blinded to patient's allocation. The researchers will be responsible for TPI and for data collection.
15822092|NCT04267302|Other|Baby Bouncer|Fischer Price baby bouncer.
15822093|NCT04267302|Other|Infant t-shirts with Language Environment Analysis (LENA) audio recorders|Infant t-shirts with wearable LENA audio recorders for 2-8 hours of recordings of vocal interaction, crying and turn-taking.
15822094|NCT04267302|Other|Baby Carrier|Ergobaby Baby carrier.
15822095|NCT04267289|Behavioral|Beating the Blues|Automated, cognitive behavioral therapy delivered via a website. There are 8 sessions, each taking one to 1.5 hours to complete. Sessions are prerecorded and sequenced. Sessions are based on the principles of cognitive behavioral therapy and include techniques such as cognitive restructuring and behavioral activation. The entire program takes about 8 to 12 weeks to complete.
15822096|NCT04267276|Drug|Part 1: BI 1265162 - intravenous|Intravenous solution
15822097|NCT04267276|Drug|Part 2: BI 1265162 - oral|Oral solution
15822129|NCT04267029|Diagnostic Test|TADPOL battery (deep clinicolaboratory profile)|"profile dimensions:
~hemolytic
~allergic
~cardiorenal
~inflammatory
~leukoagglutinating
~exploratory bioarchive"
15822130|NCT04267016|Diagnostic Test|TruGraf Testing - Peripheral blood gene expression profiling|5 mL collection PAXgene blood sample
15822292|NCT04265846|Device|bifocal IOL|The patients will undergo bilateral phacoemulsification and bifocal IOLs implantation.
15822098|NCT04267263|Behavioral|Self-guided lifestyle intervention|The intervention will consist of one 60-minute group based online session, adapted specifically for young men based previous work with young adults, followed by a self-guided program for 12-weeks. Participants will receive a tool kit that includes evidence-based resources (scale for self-weighing, handouts that will include free self-monitoring apps and strategies for no-cost exercise, sample meal plans and meal planning tips, and tips for healthy living that emphasize risk areas) to assist them during the self-guided phase, as well as weekly health risk text messages.
15822099|NCT04267250|Drug|PF-06700841|60 mg by mouth (PO) once daily (QD).
15822100|NCT04267250|Drug|Ethinyl estradiol (EE) and levonorgestrel (LN)|Oral tablet containing 30 mcg EE and 150 mcg LN.
15822101|NCT04267237|Drug|Atezolizumab|Atezolizumab 1680 mg will be administered by intravenous (IV) infusion on Day 1 of Cycles 1-12.
15822102|NCT04267237|Drug|RO7198457|RO7198457 will be administered by IV infusion at protocol-defined intervals for 12 cycles.
15822103|NCT04267224|Drug|Ticagrelor 90mg|Ticagrelor is a direct-acting inhibitor of the platelet P2Y12 receptor with a rapid antiplatelet effect. It has been shown to reduce the rate of major cardiovascular events among patients with acute coronary syndromes, as compared with Clopidogrel, and has the potential to improve coronary reperfusion and the prognosis for patients with STEMI treated with primary PCI.
15822104|NCT04267211|Other|Illustrated handout at prenatal consult|Illustrated consult group will be given an illustration paper describing the majority of the issues discussed at the prenatal consult
15822105|NCT04267211|Other|Standard Prenatal Consult|Standard prenatal consult
15822106|NCT04267198|Behavioral|Intention Treatment for Anomia|Word retrieval treatment for aphasia that engages right hemisphere intention mechanisms using a left-hand circular gesture.
15822107|NCT04267185|Behavioral|Physical Activity Together for PwMS and their CGs (PAT-MS)|A dyadic physical activity intervention approach for PwMS and their family CGs affected by moderate-to-severe MS disability.
15822108|NCT04267172|Behavioral|Surgical simulation training in primary Total Hip Arthroplasty|The simulation-based and cognitive learning package will be delivered to a randomised sub-group of 50% of the Surgical Residents recruited into this study. This will be delivered in a supervised non-clinical setting within a dedicated University-owned simulation laboratory over a 4-week period for between 1 to 2 hours per week, over 3 to 4 consecutive but separate six-month placements.
15822109|NCT04267172|Other|No intervention: Surgical Resident Control Group|Control Group
15822110|NCT04267172|Other|No Intervention: Consultant and Fellow Comparator Group|Comparator Group
15822111|NCT04267159|Other|Acute cardioversion|Acute restoration of sinus rhythm by medical or electrical cardioversion in the emergency department
15822112|NCT04267159|Other|Delayed cardioversion|Delayed restoration of sinus rhythm by medical or electrical cardioversion in the out-patient clinic
15822113|NCT04267146|Drug|Nivolumab|"Solution for intravenous injection 10 mg/ml. Initial dose : 3 mg/kg Nivolumab will be given at 3 mg/kg/injection every two weeks from the first day of radiotherapy to the last day of chemotherapy.
~One de-escalation dose : 1 mg/kg"
15822114|NCT04267146|Drug|Temozolomide|Capsules: 5, 20, 100, 140, 180 and 250 mg orally. Temozolomide will be given at 75mg/m2/day from the day of start of radiotherapy to the last day of radiotherapy, then, after one month rest at 200mg/m2/day for five consecutive days for 12 cycles (28 days cycle).
15822115|NCT04267146|Radiation|Radiotherapy|Total dose of 54 Gray(Gy) units delivered in 30 daily fractions of 1.8 Gy over 6 weeks during the chemoradiation period.
15822116|NCT04267133|Diagnostic Test|Facial video of detection of cardiac disease|This project proposes to evaluate a non-contact video recording technology to detect the presence of AF. The technology extracts a pulsatile signal by measuring the subtle variations in skin color of a patient's face (flushing) due to the variations of blood volume underneath the skin. The technology uses a standard web camera. This technique is videoplethysmography (VPG).
15822117|NCT04267120|Drug|Lenvatinib|Lenvatinib will be provided by Merck.
15822118|NCT04267120|Drug|Pembrolizumab|Merck will provide pembrolizumab
15822119|NCT04267120|Procedure|Research blood collection|-Within 2 weeks prior to first dose of study drug, cycle 4 day 1, and at the off-treatment assessment
15822120|NCT04267107|Other|Individual Managing Fatigue Program|The Individual Managing Fatigue Program includes six weekly sessions that focus on sleep, communication and body mechanics, activity stations, priorities and standards, and balancing daily schedule. Each session includes three parts: 1) a pre-session activity 2) in-session activities/information and 3) homework. Prior to coming to each session, participants will be asked to complete activities that will help them prepare for the in-session discussions. During each session participants will discuss and practice the topics most important to them. Based on their discussions, participants and therapists will decide on activities to complete during each session and as homework. The therapist will help the participant begin the homework at the end of each session, and the participant will finish it outside of the session at home. At the beginning of the following session, the therapist and participant will review the homework.
15822121|NCT04267094|Device|Iterative reconstruction at reduced radiation dose|Evaluating Agatston coronary calcium score using reduced dose acquisitions reconstructed using iterative reconstruction
15822122|NCT04267081|Drug|Venetoclax|Ex vivo venetoclax sensitivity testing is used for patient selection.
15822123|NCT04267068|Behavioral|Growth Mindset and Modifiable Risk Factor Information|15 minute interactive article describing neuroplasticity followed by 15 minute interactive article describing modifiable risk factors for depression and anxiety
15822124|NCT04267068|Behavioral|Control|30 minute interactive article describing symptoms of depression and anxiety, common concerns of college student
15822125|NCT04267055|Device|Valiant Navion Thoracic Stent Graft System|Placement of the Valiant Navion for endovascular repair of a dissection in the thoracic aorta.
15822126|NCT04267042|Drug|Budesonide|Budesonide is a corticosteroid that is commonly used intranasally to treat CRS.
15822127|NCT04267042|Device|Mucosal Atomization Device|MAD is a device used as an addition to a syringe to atomize medication to increase area of distribution. It is used to administer budesonide within the nasal passages and sinuses to administer medication for CRS.
15822128|NCT04267042|Device|NeilMed squeeze bottle for Impregnated Nasal Saline Irrigation|INSI is delivered using a NeilMed squeeze bottle. It is used to administer budesonide within the nasal passages and sinuses to administer medication for CRS.
15822357|NCT04265430|Other|Questionnaire Administration|Ancillary studies
15822131|NCT04267003|Device|Transcranial Direct Current Stimulation|In tDCS, saline-soaked electrodes are temporary affixed to the scalp and connected to a battery-powered current generator. A weak (2 mA) constant current is then briefly applied (~20 minutes) to stimulate the targeted brain area (e.g. the DLPFC). To control for placebo effects, the study will utilize a sham stimulation protocol that consists of very brief constant stimulation (~1 minute). Subjects usually cannot discern the difference between the sham and experimental stimulation protocols due to habituation.
15822132|NCT04266990|Other|Planned Sweat collection|Four times a day at fixed time points (9:30, 11:30, 13:30, 15:30), a researcher will ask the volunteers to wash their hands with non-scented soap and then place a sterile cotton gauze in the palm of their non-dominant hand. After 10 minutes, the gauze will be retrieved by the researcher.
15822133|NCT04266990|Other|Spontaneous Sweat collection|As the patient will be under continuous monitoring, sweat and saliva samples will be also collected during and/or right after a seizure occurs if the volunteer is not holding a gauze at that time. The sweat samples will be collected by the researcher by applying a sterile gauze to the patients hands, either during or immediately following a seizure during 10 minutes.
15822134|NCT04266990|Other|Healthy volunteers sweat collection|A researcher will ask the volunteers to wash their hands with non-scented soap and then place a sterile cotton gauze in the palm of their non-dominant hand. After 10 minutes, the gauze will be retrieved by the researcher. The healthy samples will be collected on the same floor of Ghent University Hospital and as close as possible to where patients reside
15822135|NCT04266977|Drug|Dexamethasone|restrictive use of DEX, based on standardized clinical and radiological criteria.
15822136|NCT04266964|Procedure|Manual examination|"With the patient in a supine position, squeeze the skinfold between your thumb and pointfinger on the inner aspect of the middle third of the thigh and on the inner aspect of the middle third of the calf.
~Place your hand under the proximal calf and the heel and move the leg into maximum flexion at the hip and knee joints. After the response, if any, is completed, move the limb back into full extension. Each of these movements lasts for one second."
15822137|NCT04266951|Behavioral|Singstrong:|Group singing and breathing control training
15822138|NCT04266938|Behavioral|Rapid start of antiretrovirals|Utilize health navigators to link patients with newly diagnosed HIV into care and treatment within 7 days
15822139|NCT04266938|Behavioral|Retrospective analysis|Review historical standard of care relative to time to start antiretrovirals and impact on retention in care.
15822140|NCT04266938|Behavioral|Non- RAPID start|Review of patients who failed to establish care and start ART within 7 days of HIV diagnosis and analyze impact on retention in care.
15822141|NCT04266925|Behavioral|3 referees present|We compared player behavior with one versus three referees present on youth soccer fields during match play. The time between these two matches ranged from a few hours to several weeks.
15822142|NCT04266925|Other|1 referee present|We compared player behavior with one versus three referees present on youth soccer fields during match play. The time between these two matches ranged from a few hours to several weeks.
15822143|NCT04266912|Drug|Avelumab|Given IV
15822144|NCT04266912|Drug|Berzosertib|Given IV
15822145|NCT04266899|Device|Foot Drop Stimulator - Neuro Orthosis|The WalkAide system is a self-contained functional electrical stimulation device with a built-in tilt sensor and attaches with a cuff to the leg below the knee. The device stimulates the peroneal nerve provides active dorsiflexion of muscle during the swing phase of gait.
15822146|NCT04266899|Device|Treadmill|Gait training on a treadmill
15822147|NCT04266886|Other|Best Practice|Receive usual care
15822148|NCT04266886|Procedure|Hypnotherapy|Receive self-hypnosis guided relaxation
15822149|NCT04266886|Other|Quality-of-Life Assessment|Ancillary studies
15822150|NCT04266886|Other|Questionnaire Administration|Ancillary studies
15822151|NCT04266873|Device|AffloVest|Form of High Frequency Chest Wall Oscillation mimicking manual techniques on a patients thorax to assist with secretion clearance. Delivered for 30 minutes, twice a day
15822152|NCT04266860|Other|Experimental - Test Results and Education|"First, these providers will receive educational materials (e.g. a slide deck, mock test result and one-page fact sheet) meant to mimic what physicians will receive in the real-world market as they learn about the DxTerity test.
~Second, within each of their second-round cases, intervention-arm physicians only will receive simulated test results from the DxTerity test at the clinically-appropriate point in each case."
15822153|NCT04266847|Device|monofocal IOL,bifocal IOL,or trifocal IOL|phacoemulsification and implantation of IOL.IOL may be monofocal IOL,bifocal IOL,or trifocal IOL
15822154|NCT04266834|Other|Experimental Arm|"First, these providers will receive educational materials (e.g. a slide deck and one-page fact sheet) meant to mimic what physicians will receive in the real-world market as they learn about the Hikari DX L-FABP test.
~Second, within each of their second-round cases, intervention-arm physicians only will receive simulated test results from the L-FABP test at the clinically-appropriate point in each case."
15822155|NCT04266821|Other|Experimental Arm|"First, these providers will receive educational materials (e.g. a slide deck, mock test result and FAQ handout) meant to mimic what physicians will receive in the real-world market as they learn about the Ethos technology.
~Second, within each of their second-round cases, intervention-arm physicians only will receive simulated test results from the Ethos test at the clinically-appropriate point in each case."
15822156|NCT04266808|Device|An interactive telehealth monitoring and biofeedback system|A pressure sensitive mat located under the user's wheelchair seat cushion and a wheelchair propulsion monitoring device attached to the chair which are interfaced with a phone App based user interface to provide feed back to promote physical activity and pressure relief maneuver performance among wheelchair users.
15822157|NCT04266808|Behavioral|Education Control|Participants will receive education on importance of pressure relief maneuvers and physical activity and the recommended amounts of each for prevention of pressure ulcer/injury and for physical health.
15822158|NCT04266795|Drug|Pevonedistat|Pevonedistat IV infusion.
15822159|NCT04266795|Drug|Venetoclax|Venetoclax tablets.
15822160|NCT04266795|Drug|Azacitidine|Azacitidine IV or SC injection.
15822161|NCT04266782|Other|Exercise program followed by long walk in group|The subjects will be included in a training exercise program for three months followed by a long-walk in group
15822162|NCT04266782|Other|Exercise program followed by long walk in group (controls)|The controls matched for age will perform the same exercise program and long walk as the PD subjects
15822163|NCT04266769|Device|LightForce Orthodontic System|The LightForce Orthodontic System is a a digital treatment planning platform and patient-specific 3D printed polycrystalline alumina brackets for the treatment of malocclusion
15822164|NCT04266756|Drug|Selexipag matrix tablet|Participants will receive single oral dose of Selexipag tablet(with fast, medium, and slow release profile) under fasted condition.
15822165|NCT04266756|Drug|Selexipag encapsulated pellets|Participants will receive single oral dose of Selexipag pellets (with fast, medium, and slow release profile) under fasted condition.
15822166|NCT04266756|Drug|Selexipag Immediate-release (IR) tablet|Participants will receive Selexipag immediate-release tablet orally under fasted condition.
15822167|NCT04266743|Device|FeetMe Monitor|"For gait parameters' evaluation, the investigator asks the participant to move in a straight line over a 10-meter mat. The participant had to start the feet in line and then start walking at a comfortable speed. During this time, the investigator records the gait parameters from the FeetMe Monitor® and Gaitrite® system.
~An operator asked the patient to repeat 3 trials. The same sequence was repeated by three other operators. The same measurement is done 7 days later.
~A questionnaire is given to assess the ergonomics of the device"
15822168|NCT04266730|Biological|PANDA-VAC|The primary therapeutic neoantigen vaccine product, Personalized and Adaptive Neoantigen Dose-Adjusted Vaccine (PANDA-VAC), will be comprised of 6 peptides at a dose of 300 micrograms (µg) per peptide admixed with local adjuvant Stabilized polyriboinosinic/polyribocytidylic acid (Poly-ICLC).
15822169|NCT04266730|Drug|Pembrolizumab|Pembrolizumab will be administered at 200 mg IV dose every three weeks. The subject may transition to 400 mg every six weeks if, after the first scan done after start of treatment, they have a partial response or better or after two scans with stable disease or better.
15822170|NCT04266717|Behavioral|Baby Play Intervention|Baby Play Intervention involves teaching parents targeted ways they can handle, position, and play with young infants that aim to provide infants enhanced early opportunities to learn to control their bodies and interact with objects. These abilities are associated with future motor, cognitive, and language outcomes. Parents will be asked to perform the intervention activities 20 minutes daily and to log their activity performance weekly.
15822171|NCT04266717|Behavioral|Milestone Education|Parents in the Milestone Education Intervention group will receive information regarding milestones expected based on infants' CA. This information is based on forms from the Centers for Disease Control and Prevention (CDC) and The American Academy of Pediatrics (AAP). This will help parents understand the milestones typically observed at the their child's CA and reflects the education parents receive from healthcare providers. Parents will be asked to provide their infants opportunities to perform these milestone behaviors 20 minutes daily and to log their activity performance weekly.
15822172|NCT04266704|Behavioral|Sharing Intervention|intervention includes both analytic and socioemotional components related to self-management of hypertension and is specifically targeted to African American women. Along with providing education on lifestyle changes to lower blood pressure, DASH diet, exercise, and medication adherence (analytic components), the intervention is designed to promote social activities around blood pressure self-management, in particular, sharing blood pressure management information with peers (socioemotional components).
15822173|NCT04266691|Other|nonIntervention|nonIntervention
15822174|NCT04266678|Behavioral|Resistance exercise program|Exercise sessions with exercise science professional. Target hypertrophy repetition range and progressive resistance exercise.
15822175|NCT04266665|Drug|Dexmedetomidine|Dexmedetomidine 2 μg/ml will be given as bolus 1mg/kg for 10 minutes with a maintenance dose of 0.8μg/kg/h until surgery completion
15822176|NCT04266665|Other|Normal saline|Equivalent doses for a solution containing 2mcg/ml of the tested drug calculating for a bolus 1mg/kg for 10 minutes with a maintenance dose of 0.8μg/kg/h until surgery completion
15822177|NCT04266652|Procedure|tooth block|tooth root blocks were used to increase the bone width
15822178|NCT04266652|Procedure|autogenous bone block|autogenous bone block were used to increase the bone width
15822179|NCT04266639|Device|Remote Ischemic Conditioning|RIC is commonly achieved by inflation of a blood pressure cuff to induce 5-minute cycles of limb ischemia alternating with 5 minutes of reperfusion
15822180|NCT04266639|Device|Sham Remote Ischemic Conditioning|Sham Comparator (Sham-RIC)
15822181|NCT04266626|Other|kinesiotaping therapy|Kinesiotaping is a new therapeutic technique that gives support to the lip and tongue base muscles without restricting range of motion or blood flow.
15822182|NCT04266626|Other|oral motor manipulation therapy|Manipulation therapy include tapping and massage of oral motor muscles including orbicularis oris and base of tongue.
15822183|NCT04266613|Diagnostic Test|TruGraf® Testing|5 mL collection PAXgene blood sample
15822184|NCT04266600|Procedure|Extensive mesentery resection|Surgeons will perform a high ligation of the ileocolic pedicle, between the superior mesenteric artery and the bifurcation of the ileal and right colic branches, and to fully mobilize the mesentery off of the retroperitoneum prior to bowel transection and anastomosis
15822185|NCT04266587|Biological|Blood sampling|blood sampling is done on healthy volunteers
15822186|NCT04266574|Device|Near Infrared Spectroscopy (NIRS)|"The anesthesiologist will apply optodes before induction of anesthesia and before preoxygenation, to detect baseline NIRS level, NIRS will be monitored continuously up to post-anaesthesia care unit (PACU) discharge, or up to three the investigator's after ICU admission.
~When a decrease in NIRS value over 10% is detected, or if NIRS value is below 60%, patients will start hemodynamic optimization, to reverse the reduction in NIRS and return to baseline values, according to a predefined protocol."
15822187|NCT04266574|Device|Standard Care|Controls will be treated according to standard of care, maintaining a MAP≥65 and an adequate cardiac output according to the hemodynamic monitoring chosen by the anesthesiologist (invasive blood pressure monitoring or pulse contour monitors). NIRS will be recorded also in controls, but caring anesthesiologists will be blinded to NIRS.
15822188|NCT04266561|Other|hernia repair|Two 3-mm needle holders were used for stitching the wide IIR. Then the suture was continued along the upper margin of IIR, but in a deeper plane to include the peritoneum and the deeper fascia transversalis.
15822218|NCT04266340|Drug|midazolam|0.05mg/kg intravenous injection midazolam
15822219|NCT04266340|Drug|Saline|no premedication
15822291|NCT04265859|Behavioral|Mindfulness|The MBT-based regulation training involves using a mindfulness strategy that instructs participants to notice and accept their feelings without judgment or intent to act upon them.
15822189|NCT04266548|Procedure|Superselective Intra-arterial Hepatic Injection of Indocyanine Green (ICG) for Fluorescence Image-guided Segmental Positive Staining|The patients with single HCC which is planned to received laparoscopic hepatectomy were involved. Procedures were performed in conventional angiography room. The celiac trunk was catheterized and a microcatheter was advanced into segmental hepatic artery branches which supplied the HCC. The 5cc 0.125 mg/cc ICG was injected from super-selective hepatic artery in operative room. A Near-Infrared laparoscope was used to detect the fluorescent signal to assess the correspondence between arterial-based fluorescence demarcation and ultrasound-based surgical demarcation.
15822190|NCT04266535|Device|Target controlled infusion|Target controlled infusion vs manually controlled infusion
15822191|NCT04266522|Other|Informational Intervention|Receive printed materials
15822192|NCT04266522|Other|Counseling|Receive direct physicist interactions to describe the technical aspects of the treatment
15822193|NCT04266522|Other|Questionnaire Administration|Ancillary studies
15822194|NCT04266509|Drug|PF-06651600|50 milligram (mg) tablet
15822195|NCT04266509|Drug|Rifampin|600 mg provided as two 300 mg capsules.
15822196|NCT04266496|Other|Questionnaires|ICIQ FLUTS (women) or MLUTS (mannen) CIVIQ 2 PSQI
15822197|NCT04266496|Diagnostic Test|Frequency Volume Chart|Collect a frequency volume chart for 3 days: measure the amount of voids and volume urinated.
15822198|NCT04266496|Diagnostic Test|Collect urine during 1 day|Volunteers are asked to collected their urine during the last day of the frequency volume chart. Volunteers get 2 jars: One for collection during the day, and 1 for overnight collection of urine. Osmolality and sodium of urine is tested
15822199|NCT04266496|Diagnostic Test|Blood sample|Blood collection to measure plasma sodium and osmolality.
15822200|NCT04266496|Diagnostic Test|Measurement of the circumference of the lower legs|"Circumference of the lower legs wil be measured twice:
~After awakening, when still laying dowing in bed
~Before goin to sleep
~Circumference should be measured 2 cm above the medial malleolus"
15822201|NCT04266470|Device|Lara Scan|"Four (4) sensors will be placed prior to the injection of 18 F-fludeoxyglucose (18FDG) at the following sites: 7 cm above injection site; injection site; surface of palpable presumed malignant tissue; palpable carotid artery.
~Standard doses of 18-FDG will be injected per Department of Radiology protocols
~All injections will be evaluated to insure the total dose of 18-FDG has been injected. Injections resulting in moderate to severe extravasations, as interpreted by Lara software, will be segregated and evaluated on an individual basis.
~The sensors will remain in place for 60 minutes during the 18-FDG uptake period with the patient in a reclined chair.
~After the uptake time is complete, the sensors will be removed by the technologist and the participant will be released.
~The study team will then upload the sensor data to a personal computer in the treatment planning room where it will be coded and processed as a Lara scan."
15822202|NCT04266470|Diagnostic Test|PET/CT Scan - Pre-treatment and Post-treatment|The PET/CT imaging will be conducted according to standard of care. The main alteration to process flow will be the addition of the Lucerno sensors just prior to the injection of the PET material.
15822203|NCT04266457|Other|No Intervention|No Intervention
15822204|NCT04266444|Device|Exergaming in virtual environment|"The 10Cubes game (by I. Cikajlo) will be used. In the game, the motion of the hand, wrist and fingers is tracked by an infra-red camera (by LeapMotion, Inc.) and hand motion is reflected in the virtual environment. The software will run on a powerful computer with a 19 display. Each group will have the game set to a different level of difficulty."
15822205|NCT04266431|Behavioral|EMPOWER|Behavioral weight loss intervention
15822208|NCT04266405|Dietary Supplement|Placebo drink|consume 1 bottle (50 mL) per day for 28 days
15822209|NCT04266405|Dietary Supplement|Collagen Cubilose Drink|consume 1 bottle (50 mL) per day for 28 days
15822210|NCT04266392|Drug|[18F]-DCFPyl Ligand|To assess the performance of [18F]-DCFPyl PET with whole-body MRI and multiparametric pelvic/prostate MRI for PCa detection in men with recurrence as determined by biochemical PSA level or evidence on CIM. Results of tracer uptake and MRI image features on whole body PET/MRI and dedicated pelvic/prostate PET/MRI, alone and together, will be correlated and compared to detection of lesions on CIM that usually includes bone scan (BS) and CT scan of the abdomen and pelvis, or PET imaging with F-18 Fluciclovine.In addition, in patients who undergo biopsy when performed as standard of care, we will correlate image features directly with histopathological findings on lesion biopsy to directly demonstrate that 'radiotracer and/or MRI positive' lesions contain tumor cells.
15822211|NCT04266379|Device|Closed-loop insulin infusion driven by continuous glucose monitoring through an algorithm, in free-life conditions|Continuous subcutaneous insulin infusion according to an automated algorithm from continuous glucose monitoring data
15822212|NCT04266379|Device|Continuous Subcutaneous Insulin Infusion and Continuous Glucose Monitoring|Insulin delivered subcutaneously by a pump and manage by the patient with the help of a CGM sensor
15822213|NCT04266366|Other|Face-to-Face Rehabilitation program|In each hospital, two trained therapists will carry out a face-to-face rehabilitation program consisting of electroanalgesia and an exercise program that follows the Mckenzie method. The physiotherapists place the electrodes in the patients, for this they use 5x9 cm electrodes, which they place at the bilateral paravertebral level, in the patients who present with radicular pain, the electrodes will be placed in the path of the affected nerve. The duration will be sufficient to carry out the Mckenzie protocol. Mckenzie exercises are designed to make changes in the internal periarticular components of the spine.
15822214|NCT04266366|Other|Telemedicine program|It consists in an e-Health rehabilitation program through a web platform performing electroanalgesia and an exercise program following the Mckenzie method. Patients will be instructed in the use of the TENS device using 5x9cm electrodes at the bilateral paravertebral level, the patients that present radicular pain, the electrodes will be placed in the path of the affected nerve. The realization of exercises will be through the application of an Mckezie protocol. The duration will be the same as that used to carry out the Mckenzie protocol. Mckenzie exercises are designed to make changes in the internal components periarticular of the spine.
15822215|NCT04266353|Dietary Supplement|Resveratrol (RSV)|Participants will receive Resveratrol at 150 mg daily for 6 weeks.
15822216|NCT04266340|Drug|dexmedetomidine|2.5µg/kg intranasal dexmedetomidine group
15822217|NCT04266340|Drug|midazolam|0.5mg/kg oral midazolam
15822220|NCT04266327|Radiation|3D-printing Template-assisted CT-guided I-125 Seed Implantation|(1) positioning and preoperative plan design;(2) 3D printing template design and production;(3) reset and seed implantation;(4) intraoperative optimization;Postoperative dose verification.Dosimetric parameters include: dose D90 and D100 reaching a certain percentage target volume;Target volume V100, V150 and V200 reaching a certain percentage of prescribed dose;And the dose of organs at risk: Dmean, D2cc, d0.5cc, d0.1cc.Regular follow-up was conducted after treatment.
15822221|NCT04266314|Device|Maternal-fetal monitoring|Maternal-fetal monitoring evaluates fetal and maternal heart rate, maternal respirations, fetal movement, and maternal skin conductance (a way to monitor emotional response)
15822222|NCT04266314|Other|NICU Network Neurobehavioral Scale|Evaluates neurobehavioral organization, neurological reflexes, motor development, and signs of stress and withdrawal of substance-exposed infants.
15822223|NCT04266301|Drug|MBG453|A dose of MBG453 800 mg will be administered intravenously (IV) every 4 weeks (Q4W).
15822224|NCT04266301|Drug|Azacitidine|A dose of Azacitidine 75 mg/m2 will be administered IV or subcutaneously (SC) on Day 1-7, or Day 1-5, 8 and 9.
15822225|NCT04266301|Drug|Placebo|A dose of Placebo 800 mg will be administered intravenously every 4 weeks (Q4W).
15822226|NCT04266288|Drug|Ketamine|Active drug
15822227|NCT04266288|Drug|Sodium Chloride 0.9%|Placebo
15822228|NCT04266275|Drug|Curcumin C3 Complex|"Curcumin (Curcumin C3 Complex prepared by Sabinsa Corporation), a constituent of the spice turmeric, is considered to be a low-toxicity, dietary-derived agent with chemopreventative and therapeutic benefits.
~Study participants will be instructed to insert four 500 mg (2000 mg total) curcumin capsules once a week (excluding days when they are on their menses) for 20 weeks. Participants will insert capsules using the vaginal applicator while lying on their back with their knees bent. Participants will be instructed to gently insert the capsules into the vagina as far as they will go comfortably, similar to a tampon insertion or other common intravaginal drugs.
~Cervical cytology and HPV testing will be performed at baseline and 6 months after the baseline visit. If cervical cytology or HPV testing is abnormal at 6 months, a colposcopy with biopsies will be performed. All samples will be used to analyze for the study outcomes."
15822229|NCT04266275|Drug|Placebo|"Study participants randomized to the placebo arm will insert four 500 mg (2000 mg total) of the placebo (gelatin) capsules once a week (excluding days when they are on their menses) for 20 weeks. Participants will insert the capsules using the vaginal applicator while lying on their back with their knees bent. Participants will be instructed to gently insert the capsules into the vagina as far as they will go comfortably, similar to a tampon insertion or other common intravaginal drugs.
~Cervical cytology and HPV testing will be performed at baseline and 6 months after the baseline visit. If cervical cytology or HPV testing is abnormal at 6 months, a colposcopy with biopsies will be performed. All samples will be used to analyze for the study outcomes."
15822230|NCT04266262|Behavioral|High-intensity interval training (HIIT)|"Supervised HIIT sessions (2x/week) will comprise cycling 10 x 60 secs at 85-95% maximum heart rate (HRmax) interspersed by 60 secs of low-intensity recovery.
~Unsupervised HIIT sessions (1x/week) will involve 10 x 60 secs of walking or alternative (intensity of 7-9 on the 0-10 RPE) interspersed by 60 secs of walking or cycling at low intensity recovery (RPE 3-5)."
15822231|NCT04266262|Behavioral|High-Intensity resistance training (HIRT)|"Supervised HIRT sessions (2x/week) will comprise 2-3 sets of 6-8 repetitions progressively achieving 85% of 1RM.
~Unsupervised HIRT sessions (1x/week) will involve 2-3 sets of 15-20 repetitions using a resistance exercise band when necessary."
15822241|NCT04266236|Procedure|L3 LPB|ultrasound-guided L3 lumbar plexus block
15822242|NCT04266236|Procedure|L4 LPB|ultrasound-guided L4 lumbar plexus block
15822243|NCT04266236|Procedure|T12 block|ultrasound-guided thoracic 12th segment nerve block
15822244|NCT04266236|Procedure|L3 QLB|ultrasound-guided quadratus lumborum block at L3 level
15822245|NCT04266236|Drug|0.375%ropivacaine 25 ml (Raropin)|0.375%ropivacaine (Raropin) 25ml will be given
15822246|NCT04266236|Drug|0.375%ropivacaine 40 ml (Raropin)|0.375%ropivacaine (Raropin) 40ml will be given
15822247|NCT04266236|Procedure|General anesthesia with tracheal intubation|General anesthesia with tracheal intubation will be induced with sufentanil, propofol, vecuronium for every patient before the operation and maintained with sevoflurane during the operation
15822248|NCT04266223|Device|Mask-free surface monitoring|Mask-free headrest and couch for patient positioning for radiation therapy combined with a surface monitoring system
15822249|NCT04266210|Device|Fuji Bulk|Restorative system
15822250|NCT04266210|Device|G-ænial Posterior|Restorative system
15822251|NCT04266197|Combination Product|Drug: RT234 - vardenafil inhalation powder; Device: Axially Oscillating Sphere dry powder inhaler (AOS DPI)|RT234 is a drug/device combination product composed of vardenafil hydrochloride as the drug constituent and will utilize AOS DPI device (RPC Plastiape, Osnago, Italy).
15822252|NCT04266184|Other|Kinesio tape (KT)|"For abdominal taping, four I-shaped tapes will be used. Two of them will start from the superior symphisis pubis, follow the rectus abdominis muscle, and finish at the xiphoid process. Other two I-shaped tapes will start from the mid-symphisis pubis, follow the external oblique abdominals, and finish at the spina iliaca anterior superiors.
~Symphisis pubis taping will be applied with two I-shaped tapes, by forming a X shape.
~For lumbopelvic taping, three I-shaped KTs will be used. Two tapes will be applied bilaterally and longitudinally on the lumbar erector spinal muscles. The third tape will start from one sacroiliac joint and end at the other, vertically to the previous two tapes, forming a H-shape.
~All tapings will be applied with 15-25% tension (tape-off tension). KTs will stay three days. They will be removed from the site, and the skin will be checked and cleaned. Then, they will be reapplied for the next three days."
15822290|NCT04265859|Behavioral|Cognitive Behavioral Training|The CBT-based regulation training involves using a cognitive strategy that instructs participants to reappraise situations in positive or less negative ways.
15822253|NCT04266184|Other|Pelvic belt (PB)|The women in this group will use the belts, after adjusting them at a comfortable tension, after getting up the bed in the mornings, during daily activities and walking. Evaluation will be made three days after the first application and they will be asked to continue using it for the second three-day period.
15822254|NCT04266184|Other|Educational program|This program will include pain neuroscience education and ergonomic education, and will approximately last one hour.
15822255|NCT04266171|Behavioral|Diet education based on CGMS data|Intervention group will receive diet education based on CGMS data, using post prandial glucose response, calculated by incremental area under curve of glucose level. Control group will receive conventional diabetes diet education without CGMS data.
15822256|NCT04266171|Behavioral|Conventional diet education|Control group will receive conventional diabetes diet education without CGMS data.
15822257|NCT04266158|Device|Myoelectric UE Device-UE Orthosis-No Device|all subjects receive 2 education sessions, during which they are trained on the donning and use of the MyoPro 2 Motion-G, orthosis, and no device, all on the affected UE. The presentation and training on these interventions is non-randomized and administered to all subjects.
15822258|NCT04266145|Drug|intravenous dexmedetomidine|adductor-canal-blockade with 20 mL 0.25% levobupivacaine plus 1 mL normal saline while, the intravenous solution; consists of 0.5µg.kg-1 dexmedetomidine diluted in 20 mL normal saline
15822259|NCT04266145|Drug|adductor canal block dexmedetomidine|adductor-canal-blockade with 20 mL 0.25% levobupivacaine plus 1 mL of 0.5µg.kg-1 dexmedetomidineline while, the intravenous solution;consists of 20 mL normal saline
15822260|NCT04266132|Procedure|General anaesthesia|General anaesthesia will be induced with 8% sevoflurane in oxygen and maintained with 1 MAC sevoflurane via a laryngeal mask.
15822261|NCT04266132|Procedure|Ultrasound-guided RLB|The suggested ultrasound transducer orientation is sagittal paramedian (cephalacaudad direction). We begin our ultrasound scanning in a paramedian sagittal plane by finding desired level (T12- L1).The transverse process view, the costotransverse ligament can be visualized above the paravertebral space. Continuing to scan from lateral to medial, the vertebral laminae come into view.
15822262|NCT04266132|Procedure|Ultrasound-guided INB|A high-frequency probe is placed medial to the anterior superior iliac spine with the axis facing the umbilicus. A needle is inserted toward the ilioinguinal nerve as it runs between the transversus abdominis and internal oblique.
15822263|NCT04266132|Drug|Bupivacaine|0.3 ml.kg of 0.25% bupivacaine will be injected under visualization.
15822264|NCT04266119|Behavioral|Online HOPE intervention|Online HOPE intervention to increase mental health literacy
15822265|NCT04266106|Drug|SuperBio probiotic|One capsule po BID for 28 days
15822266|NCT04266106|Drug|Placebo|One capsule po BID for 28 days
15822267|NCT04266080|Other|Fitbit Inspire HR|assessing step counts
15822268|NCT04266080|Other|Questionaires|Patient-Reported Outcomes Measurement Information System (PROMIS)
15822269|NCT04266067|Other|PNF exercise|Proprioceptive neuromuscular facilitation (PNF) is a form of neuromuscular retraining type containing the stimulation of sensory receptors to provide information about the body position and movement to facilitate the intended movement
15822270|NCT04266067|Other|Frenkel exercise|The Frenkel exercises consist of a series of slow, repetitive movements performed in different positions while lying, sitting and standing.
15822271|NCT04266054|Behavioral|Digital Storytelling Intervention|12-minute digital storytelling intervention in Spanish, with four individuals explaining their personal Type 2 Diabetes stories.
15822272|NCT04266041|Diagnostic Test|High-density electroencephalogram (HD-EEG)|This study will focus on obtaining a special type of high-density scalp electroencephalography (HD-EEG) recordings in patients with neurological disorders (i.e., epilepsy, brain tumor, stroke, etc.) and appropriately matched controls. HD-EEG is a scalp EEG which uses up to 256 channels compared to the standard 21 channels used for routine clinical applications. The reason for using more channels to record is for more precise localization of epileptogenic foci and/or more precise mapping of brain functions. This type of EEG requires the use of patient's own MRI scan to precisely localize activity. Therefore, all patients and controls getting an HD-EEG will require a structural MRI scan.
15822273|NCT04266028|Biological|DM-101|Ascending DM-101 doses in each cohort
15822274|NCT04266015|Dietary Supplement|Enteral nutrition formula|Intervention group will receive nasogastric feeding with commercially available liquid enteral diet (250 ml/can, Kcal/ml, 10.4 g protein/can) during free flap reconstruction at feeding rates 10-30 ml/h.
15822275|NCT04266002|Other|Validation of Charter score for the CNS diffusion of antiretroviral drugs|IHFB001 (Neuroplustrois) is a pilot study, phase IV, open-label, multicenter in Ile-de-France region, trying to demonstrate the improvement of cognitive change after treatment characterized by its better diffusion in the central nervous system. The characteristics of the change in treatment are (Cn - Ci) ≥ 3 and Cn ≥ 9, where Cn is the Charter score of the new treatment and Ci the Charter score of the initial treatment.
15822276|NCT04265989|Device|Single BMS|Single bare metal stent covered the coronary artery aneurysm
15822277|NCT04265989|Device|Single or Double BMS|Single or double layer bare metal stents covered the coronary artery aneurysm
15822278|NCT04265989|Device|Single or Double BMS|Treated with single or double layer bare metal stents
15822279|NCT04265989|Device|BMS+DES|Treated with bare metal stent combined with drug eluting stent
15822280|NCT04265963|Biological|CD123 CAR-T cells|CD123 CAR-T cell therapy
15822282|NCT04265924|Other|fraction of inspired oxygen (FIO2)|The fraction of inspired oxygen (FIO2) is given accordingly (>0.85 for the >0.85 group, and <0.7 for the <0.7 group) to the patients during the surgery.
15822287|NCT04265898|Device|The Digital Virginia Tech Carilion Cognitive Examination|Completion of a newly developed digital cognitive screen
15822288|NCT04265885|Other|collection of testimonies from transgender people|guided interview
15822289|NCT04265872|Drug|Bortezomib; pembrolizumab and cisplatin injections--bortezomib followed by pembro/cis|injection into a vein
15822293|NCT04265846|Device|mix bifocal IOL|The patients will undergo phacoemulsification and mix different bifocal IOLs implantation bilaterally.
15822294|NCT04265846|Device|trifocal IOL|The patients will undergo bilateral phacoemulsification and trifocal IOLs implantation.
15822295|NCT04265846|Device|EDOF IOL|The patients will undergo bilateral phacoemulsification and EDOF IOLs implantation.
15822296|NCT04265846|Device|different IOLs|The patients will undergo phacoemulsification and different IOLs implantation bilaterally.
15822297|NCT04265846|Device|monofocal IOL|The patients will undergo bilateral phacoemulsification and monofocal IOLs implantation with monovision designed.
15822298|NCT04265846|Device|monofocal IOL|The patients will undergo bilateral phacoemulsification and monofocal IOLs implantation with emmetropia designed.
15822299|NCT04265833|Other|Biodentine|Biodentine has been shown to cause increased calcium ion release and this increase has been associated with the presence of pure tricalcium silicate and calcium chloride and the increased Ca(OH)2 formation
15822300|NCT04265833|Other|TheraCal LC|TheraCal LC (Bisco Inc, IL, USA) is a light-cured, resin-modified, calcium silicate-based material designed as a direct/indirect pulp-capping material. This agent has been shown to increase the pH on the pulpal surface thereby stimulating regenerative processes in the pulp, and ultimately contributing to the formation of dentin bridge
15822301|NCT04265833|Other|Calcium hydroxide|Calcium hydroxide (Ca[OH]2) is a successful pulp-capping agent activating the repair mechanism by stimulating the dentin-pulp complex. Ca(OH)2, with its bactericidal effects, protects the complex from bacterial effects and also has a stimulating effect on dentin remineralization
15822302|NCT04265820|Device|unilateral implantation of IOL|unilateral phacoemulsification and implantation of IOL.IOL may be monofocal,bifocal ,or trifocal，according to the patients preference and the eyes condition.
15822303|NCT04265820|Device|bilateral implantation of IOL|bilateral phacoemulsification and implantation of IOL.IOL may be monofocal,bifocal ,or trifocal，according to the patients preference and the eyes condition.
15822304|NCT04265807|Device|Active Remote Ischemic Conditioning|A standard non-invasive blood pressure cuff (e.g., American Diagnostics Corporation, Hauppauge, NY but any one can be used off the shelf) and disposable plastic clamp (e.g.,Medline Industries Incorporated, Mundelein, IL) can be used to apply RIC in patients resuscitated from OHCA via three cycles of 5-mins. inflation to 200 mmHg followed by 5-mins. deflation of a blood pressure cuff on a upper extremity. The cuff occludes the artery; the clamp maintains pressure in the air bladder of the cuff during the inflation periods.
15822305|NCT04265807|Device|Sham Remote Ischemic Conditioning|The control group will have a sham package opened at the bedside as soon as feasible after ED arrival. This will be identical in size, weight and appearance as that in the intervention group, but will contain a sham device. Upon identification that the patient has been randomized to the control group, the care team will proceed with all other resuscitative measures as in the the intervention group.
15822306|NCT04265794|Behavioral|H2GO!|Child participants will participate in a 6-week behavioral intervention consisting of 12 group-based weekly sessions (1-hour sessions twice a week) delivered by trained staff in the Boys and Girls Club setting. Each week consisted of a 1-hour health session and a 1-hour narrative session (delivered on separate days). Child participants will also receive reusable water bottles and a pictorial intervention booklet, which includes worksheets and parent-child take-home activities targeting attitudes, knowledge, and skills related to sugar-sweetened beverage and water consumption. Parent participants will be exposed to intervention messages (e.g., reduce SSB intake) through weekly parent-child take-home activities, child sharing of narratives produced, and a culminating open house event.
15822307|NCT04265781|Drug|BAY1817080|Three different doses over the course of study
15822308|NCT04265781|Drug|Matching Placebo|Matching Placebo to BAY1817080
15822309|NCT04265768|Procedure|Soft tissue augmentation surgery with CTG|"An epithelial-connective tissue graft of approximately 2-3 mm of thickness and adequate length will be taken from the palate or retromolar region of the patient and de-epithelialized with a scalpel (ideally a thickness of 1.5-2.0mm).
~The connective tissue graft (CTG) obtained will then be positioned buccally to the dental implant and sutured to the internal side of the flap so to provide soft tissue bulk at the level of the neck of the implant and simulate a root prominence for the missing tooth."
15822310|NCT04265768|Procedure|Soft tissue augmentation surgery with Fibro-Gide|Fibro-Gide will be used to obtain buccal soft tissue augmentation. Fibro-Gide will be trimmed with a scalpel and adjusted in size and thickness to better adapt to the area buccal to the implant. In particular, the graft will be shaped in order to obtain a graft of approximately 2-3 mm of thickness and adequate length. Fibro-Gide will then be sutured to the inner side of the buccal flap, before repositioning the flap and suturing it in a tension-free way.
15822311|NCT04265768|Procedure|No soft tissue augmentation|During implant placement surgery, no soft tissue augmentation will be performed
15822312|NCT04265755|Drug|Erenumab|Erenumab 70 mg or 140 mg packed in a SureClick® Autoinjector Pen (AI)
15822313|NCT04265742|Radiation|bone densitometry|Bone Mineral Density (BMD), body composition, vertebral fractures
15822314|NCT04265742|Radiation|High resolution peripheral QCT|High resolution peripheral QCT (HR-pQCT): bone microarchitecture and bone strength
15822315|NCT04265742|Diagnostic Test|Collection of biological samples|Peripheral blood and urine samples to assess bone turnover markers and cytokines; and faeces to assess gut microbiota composition
15822316|NCT04265742|Other|questionnaires|Epidemiologic and nutritional questionnaire and physical activity scale
15822317|NCT04265742|Other|clinical tests|physical performance tests and grip strenght measurement
15822318|NCT04265729|Dietary Supplement|Neocate Infant and Junior marketed products|use of Neocate Infant and Junior marketed products
15822319|NCT04265716|Other|Topical L. reeuteri|Tubes with ointment containing L. reuteri DSM17938
15822320|NCT04265703|Procedure|Internal jugular vein catheterization|Catheterization of internal jugular vein with real-time (in-plane) method, with neutral neck position. Standard aseptic technique.
15822321|NCT04265703|Procedure|Subclavian vein catheterization|Catheterization of subclavian/axillary vein with infra-clavicular approach with real-time (in-plane) method, without shoulder retraction. Standard aseptic technique.
15822322|NCT04265703|Procedure|Innominate vein catheterization|Catheterization of innominate vein with supra-clavicular approach with real-time (in-plane) method, with neutral shoulder position and no shoulder retraction. Standard aseptic technique.
15822323|NCT04265690|Behavioral|Cooking classes|Participants will receive 2 cooking classes (each 1-hour long) during their Centering group-care visit at the BMC teaching kitchen, taught by a Registered Dietitian. The recipes taught during the cooking classes will follow the Special Supplemental Nutrition Program for Women, Infants, and Children, the 2015-2020 Dietary Guidelines for Americans, and recommendations from The American College of Obstetricians and Gynecologists.
15822324|NCT04265690|Behavioral|Text messages|Participants will receive text messages, through a password secured phone, based on their content and frequency preferences.
15822325|NCT04265677|Other|Telemedicine FCR|Parents/guardians will be able to join family centered rounds using telemedicine (audio and visual)
15822326|NCT04265677|Other|Standard of care|Parents/guardians will not be able to join family centered rounds using telemedicine (audio and visual)
15822327|NCT04265664|Behavioral|Telerehabilitation|Participants in the telerehabilitation program will receive a graded exercise and self-management intervention. This program will be delivered in a ≤2:1 participant:therapist ratio. Each participant grouping will receive two 60-90 minutes telerehabilitation sessions per week for 4 weeks focusing on lower extremity recovery (total 8-12 hours), with a therapist trained in the use of technology for the provision of rehabilitation. Participants will also be asked to complete at least one additional independent self-managed exercise session each week. This independent exercise session will include selected exercises from the telerehabilitation sessions that will be safe to perform without therapist oversight, and jointly agreed upon by the participant and therapist.
15822328|NCT04265651|Drug|Infigratinib 0.016 mg/kg|"Initial cohort dose of infigratinib at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria.
~Infigratinib tablets to be administered by mouth."
15822329|NCT04265651|Drug|Infigratinib 0.032 mg/kg|"Subsequent cohort dose escalation based on protocol-specific criteria.
~Infigratinib tablets to be administered by mouth."
15822330|NCT04265651|Drug|Infigratinib 0.064 mg/kg|"Subsequent cohort dose escalation based on protocol-specific criteria.
~Infigratinib tablets to be administered by mouth."
15822331|NCT04265651|Drug|Infigratinib 0.128 mg/kg|"Subsequent cohort dose escalation based on protocol-specific criteria.
~Infigratinib tablets to be administered by mouth."
15822332|NCT04265638|Behavioral|Exercise|One on one exercise with a cancer exercise specialist 1 hour 3 times a week for 12 weeks.
15822333|NCT04265625|Device|endoscopic guidance|Percutaneous tracheotomy performed by endoscopic guidance
15822334|NCT04265612|Procedure|"Pico® negative pressure dressing"|"Pico® negative pressure dressing that will be placed in the operating room in both sternal wound and saphenectomy.The dressing will remain on for 7 days without waking up, unless it is saturated, in which case only the dressing will be changed"
15822335|NCT04265612|Procedure|"Aquacel Surgical® hydrogel dressing"|"Aquacel Surgical® hydrogel dressing that will be placed in the operating room in both sternal wound and saphenectomy. This dressing will remain in place for 7 days without getting up, unless it has become saturated, in which case, only the dressing will be changed."
15822336|NCT04265586|Behavioral|Education|"Sleep hygiene education is either face-to-face appointment or video-meeting with trained nurse."
15822337|NCT04265586|Behavioral|Web-based Cognitive Behavioural Therapy (iCBT)|iCBT is a web-based programme (7-16 weeks) designed to treat the symptoms of insomnia.
15822338|NCT04265560|Other|Progressive Resistance Training|Progressive resistance training programme for individuals following spinal cord injury.
15822339|NCT04265547|Behavioral|Breast Cancer Risk Reduction Household Intervention|This study will focus the intervention on ways at the individual level to reduce sources of Polycyclic Aromatic Hydrocarbons (through cooking methods, exposure to cigarette smoking, indoor air filters) and also individual ways to reduce sources of other Endocrine Disrupting Chemicals. Mother-daughter pairs will partake in an educational session at the baseline visit, covering topics on reading labels, cleaning habits, and cooking methods for reducing exposures. Participants will also be introduced to free resources for consumer product safety information. The intervention arm will receive a 6-month supply of soap, lotion, deodorant, lip balm, a mop, cleaning cloths, and an air filter to take home with them. Pairs in both study arms will return for a second clinic visit 6 months after the pre-intervention visit for blood and urine sample collection, Optical Spectroscopy measurement, and questionnaire completion. The control arm will be offered the intervention products at this time.
15822340|NCT04265534|Drug|Telaglenastat|Oral Glutaminase Inhibitor
15822341|NCT04265534|Drug|Carboplatin Chemotherapy|IV infusion
15822342|NCT04265534|Drug|Pemetrexed Chemotherapy|IV infusion
15822343|NCT04265534|Biological|Pembrolizumab Immunotherapy|IV infusion
15822344|NCT04265534|Drug|Placebo|Oral placebo
15822345|NCT04265534|Dietary Supplement|Folic acid 400 -1000 μg|Orally, once daily beginning 7 days prior to the first dose of pemetrexed and continue until 21 days after the last dose of pemetrexed.
15822346|NCT04265534|Dietary Supplement|Vitamin B12 1000 μg|Vitamin B12 1000 μg Intramuscular injection one week prior to the first dose of pemetrexed and once every 3 cycles (9 weeks) thereafter. Subsequent vitamin B12 injections may be given the same day as pemetrexed administration.
15822347|NCT04265534|Drug|Dexamethasone 4 mg|For prophylaxis, orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.
15822348|NCT04265521|Device|Biocool Footcare|BioCool Footcare is a footbath containing granulate of sodium percarbonate that will in this study be used for treatment of foot fungus, heel cracks, calluses and/or dry feet.
15822349|NCT04265508|Other|Assessment of hemostatic profile|To assess the hemostatic profile, platelet function was analyzed by multiple electrode aggregometry (MEA) using Multiplate (ADP-, ASPI- and TRAP-test) and thrombelastometry using ROTEM (EXTEM, INTEM, FIBTEM)
15822350|NCT04265469|Other|Diabetic foot education|Give Diabetic foot education via mobile phone
15822351|NCT04265456|Drug|Pregabalin 100mg|Pregabalin is a structural derivative of the inhibitory neurotransmitter gamma aminobutyric acid with anticonvulsant, anxiolytic and sleep-modulating properties.
15822352|NCT04265456|Drug|Acetaminophen 1300mg|Acetaminophen is a non-salicylate antipyretic and non-opioid analgesic agent.
15822353|NCT04265443|Device|Percutaneous coronary intervention|PCI was performed using 2nd generation DES
15822354|NCT04265430|Other|Contrast Agent|Given IV
15822355|NCT04265430|Procedure|Magnetic Resonance Imaging|Undergo MRI
15822356|NCT04265430|Other|Quality-of-Life Assessment|Ancillary studies
15822358|NCT04265417|Procedure|Robotic Assisted Rectal Cancer Resection Alone|participants in this group underwent robotic assisted rectal cancer resection alone, the specimens were extracted through the incision on the abdominal wall.
15822359|NCT04265417|Procedure|Robotic Assisted Rectal Cancer Resection With Natural Orifice Specimen Extraction|participants in this group underwent robotic rectal cancer resection，the specimens were extractd through anus and vagina.
15822360|NCT04265391|Dietary Supplement|cookies|Either snakehead fish cookies or standard cookies were given to subjects 75g per day.
15822361|NCT04265378|Device|anodal tDCS|Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (current intensity of 1mA)
15822362|NCT04265378|Behavioral|Intensive cognitive training|Intensive cognitive training of a letter memory updating task and a 3-stage Markov decision making task, 9 sessions
15822363|NCT04265365|Device|rTMS+rPMS_iTBS_R|Repetitive peripheral magnetic stimulation (rPMS) intermittent theta-burst stimulation pattern (iTBS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times at radial nerve on the affected hand(low pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times on affected hemisphere(low pulse: 1200 pulses in total).
15822364|NCT04265365|Device|rTMS+rPMS_cTBS_R|Repetitive peripheral magnetic stimulation (rPMS) continuous burst stimulation pattern (cTBS) will intermittently give a cTBS treatment consists of a continuous train of TBS for 40 seconds repeated for 2 times at radial nerve on the affected hand(low pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times on affected hemisphere(low pulse: 1200 pulses in total).
15822365|NCT04265365|Device|rTMS +sham-rPMS|Repetitive peripheral magnetic stimulation (rPMS) sham burst stimulation pattern (sham TBS) will intermittently give a sham TBS treatment consists of a continuous train of TBS for 40 seconds at radial nerve on the affected hand(almost no pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times on affected hemisphere(low pulse: 1200 pulses in total).
15822366|NCT04265365|Device|rTMS+rPMS_iTBS_M/U|Repetitive peripheral magnetic stimulation (rPMS) intermittent theta-burst stimulation pattern (iTBS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times at median nerve/nervus ulnaris on the affected hand(low pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times on affected hemisphere(low pulse: 1200 pulses in total).
15822367|NCT04265365|Device|rTMS+rPMS_cTBS_M/U|Repetitive peripheral magnetic stimulation (rPMS) continuous burst stimulation pattern (cTBS) will intermittently give a cTBS treatment consists of a continuous train of TBS for 40 seconds repeated for 2 times at median nerve/nervus ulnaris on the affected hand(low pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times on affected hemisphere(low pulse: 1200 pulses in total).
15822368|NCT04265365|Device|sham-rTMS+sham-rPMS|Repetitive peripheral magnetic stimulation (rPMS) sham burst stimulation pattern (sham TBS) will intermittently give a sham TBS treatment consists of a continuous train of TBS for 40 seconds at median nerve/nervus ulnaris on the affected hand(almost no pulse: 1200 pulses in total). Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a sham TBS treatment consists of a continuous train of TBS for 40 seconds on affected hemisphere(almost no pulse: 1200 pulses in total).
15822369|NCT04265365|Device|rTMS + optimal-rPMS|The optimal Repetitive peripheral magnetic stimulation (rPMS) depend on previous results to give an iTBS or cTBS. Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a 2 s train of iTBS every 10s repeated 2 times for a total of 40 times on affected hemisphere(low pulse: 1200 pulses in total).
15822370|NCT04265365|Device|sham-rTMS+optimal-rPMS|The optimal Repetitive peripheral magnetic stimulation (rPMS) depend on previous results to give an iTBS or cTBS. Then following Repetitive transcranial magnetic stimulation (rTMS) will intermittently give a sham TBS treatment consists of a continuous train of TBS for 40 seconds on affected hemisphere(almost no pulse: 1200 pulses in total).
15822371|NCT04265352|Other|No intervension|There is intervention at all.
15822372|NCT04265339|Other|Smoking cessation|Participants are required to quit smoking
15822373|NCT04265326|Other|Measurement of Quality of Life|Quality of life will be measured using Head and Neck Cancer Inventory and The Functional Assessment of Cancer Therapy - Head and Neck Cancer Version 4
15822374|NCT04265313|Other|Measurement of Quality of Life|Quality of life will be measured using The Neck Dissection Impairment Index, Modified Constant-Murley Score, Short Form-36 Health Survey version-2.0.
15822375|NCT04265300|Dietary Supplement|Creative Roots|The Creative Roots beverage is a coconut water-based drink with three flavors Mixed Berry, Watermelon Lemonade, and Peach Mango. The ingredients are as follows and are the same for all three flavors: water, coconut water concentrate, citric acid, stevia leaf extract, natural flavor, rosemary extract (to preserve flavor). Contains: coconut
15822376|NCT04265287|Other|Data collection|Demographic, clinical, microbiological, critical care support and management data will be collected.
15822377|NCT04265274|Drug|Disulfiram|dosing 400mg daily
15822378|NCT04265274|Drug|Vinorelbin|25mg/m2 day 1 and 8,
15822379|NCT04265274|Drug|Cisplatin|75mg/m2 day 1
15822380|NCT04265274|Drug|Copper|2 mg of elementary Copper daily
15822383|NCT04265248|Device|Virtual Reality Headset|The subjects will wear the Virtual Reality Headset with a mobile phone inserted into it with the applications Full Dive VR and VR Ocean Aquarium 3D.
15822384|NCT04265248|Behavioral|Exercise|The subjects will perform evidence-based exercises for the neck.
15822385|NCT04265235|Other|Home-based exercise program|see 'arm' section
15822386|NCT04265222|Device|Hipcheck Software|Software
15822387|NCT04265222|Other|Conventional Fluoroscopy|Conventional Fluoroscopy
15822388|NCT04265209|Drug|SPECT|[123I]-FP-CIT SPECT imaging procedure
15822389|NCT04265209|Drug|PET|[18F] LBT-999 PET imaging procedure
15822390|NCT04265196|Other|cognitive behavioral group therapy|A unique protocol that includes cognitive-behavioral psychological therapy with emphasis on coping with pain
15822391|NCT04265196|Other|Mindfulness-based group therapy|Unique protocol that includes mindfulness-based psychological therapy with emphasis on coping with pain
15822392|NCT04265183|Other|Placing preformed metal crowns using Hall technique.|Preformed metal crowns (3M™ ESPE™ STAINLESS STEEL CROWNS) were placed after using separation elastics (Dentalastics® separators, DENTAURUM). The crowns were cemented using is a self-curing, radiopaque, fluoride-releasing, resin-modified glass ionomer luting cement (Ketac™ Cem Plus Luting Cement, 3M™ ESPE™). The technique used to place the crowns was the Hall technique (technique without tooth preparation).
15822393|NCT04265170|Device|BlastX with negative pressure therapy|Blast-X in combination with NPWT on,bacterial bio-burden in pressure ulcers assessed by Fluorescence imaging and quantitative biopsy.
15822394|NCT04265157|Procedure|Surgical technique surgical occlusion|Occlusion of hepatoduodenal ligament by clamp or occlusive bands
15822395|NCT04265144|Biological|Blood samples|62 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
15822396|NCT04265144|Other|Biopsy|Skin biopsies
15822397|NCT04265144|Other|Bronchoalveolar samples|50 ml of bronchoalveolar samples if pulmonary flare requires this type of exploration
15822398|NCT04265131|Other|art therapy|Art therapy is a form of psychotherapy that uses creative methods of expression through art media, such as pencils, clay, paint etc.
15822399|NCT04265118|Device|Sidewards Tilting Bed|Sidewards tilting of the bed is hypothesized to induce a body position change in sleeping subjects.
15822400|NCT04265105|Drug|fluticasone-vilanterol|LABA-ICS combination Inhaled Long acting Beta agonist and inhaled corticosteroid
15822401|NCT04265105|Drug|Standard Preparation|inhaled SABA or Inhaled corticosteroid
15822402|NCT04265092|Drug|Incobotulinum toxin A|Treatment consisted of 200 IU of incobotulinum toxinA injected into the TS. Outcome measures were assessed before injection, at 6 weeks and 3 months post-injection, using the Goal Attainment Scale (GAS), Twelve Item MS Walking (MSWS-12) Scale, Timed Up and Go (TUG) Test, 6 Minute Walk Test (6MWT). Spatiotemporal gait data was obtained by GAITRite.
15822403|NCT04265079|Other|Additional weight at hand|Added weight of an inactive hand orthosis (300 gram)
15822404|NCT04265066|Diagnostic Test|microcirculation|measurement of microcirculation
15822405|NCT04265053|Drug|L-NMMA|L-NMMA is a modified amino acid which competitively inhibits Nitric Oxide Synthase (NOS). It is infused acutely (~5 min) via IV catheter. Metabolized via normal metabolic (amino acid) pathways in ~24 hours.
15822406|NCT04265053|Drug|Ketorolac Tromethamine|Ketorolac is an NSAID which competitively inhibits Cyclooxygenase (COX). It is infused acutely (~5 min) via IV catheter. Metabolized in <24 hours.
15822407|NCT04265053|Drug|Ganirelix Acetate|"Gonadotropin-Releasing Hormone (GnRH) antagonist ganirelix acetate as a model to isolate estrogen and testosterone effects on the cerebrovascular system. Participants receive daily injections of ganirelix for 12-14 days for Aim 3 studies only. This will be overseen by clinical endocrinologists.
~Both males and females receive this treatment in Aim 3."
15822408|NCT04265053|Drug|Testosterone Transdermal Product|In Aim 3, males receive this for 7-9 days of the ganirelix treatment.
15822409|NCT04265053|Drug|Estradiol Topical|In Aim 3, females receive this for 7-9 days of the ganirelix treatment.
15822410|NCT04265027|Drug|50 mg BIA 9 1067|Hard Capsule; Oral
15822411|NCT04265027|Drug|25 mg BIA9 1067|Hard Capsule; Oral
15822412|NCT04265027|Drug|50 mg Ongentys|Hard Capsule; Oral
15822413|NCT04265027|Drug|25 mg Ongentys|Hard Capsule; Oral
15822414|NCT04265014|Other|Goal-directed fluid treatment|Goal-directed fluid treatment for major abdominal surgery
15822415|NCT04265014|Other|Liberal Fluid Therapy|Liberal Fluid Therapy for major abdominal surgery
15822416|NCT04265001|Drug|Hyaluronic acid in the form of hyaluronan sodium 25 mg/100 ml as a mouthwash|Topical mouthwash used three times daily for one week and patients were not allowed to eat or drink for one hour after rinsing.
15822417|NCT04264988|Procedure|Stopping of pelvic bleeding via several surgical methods|Those surgical methods were pelvic packing, electrocautery, energy devices, suturing, fastener, muscle welding, procoagulant chemicals, and combination of those
15822418|NCT04264975|Procedure|fecal microbiota transplantation|Fecal microbiota transplantation (FMT) is the administration of a solution of fecal matter from a donor into the intestinal tract of a recipient in order to directly change the recipient's microbial composition and confer a health benefit
15822419|NCT04264962|Drug|Yang Yin Fu Zheng Jie Du therapy|Yang Yin Fu Zheng Jie Du is a Chinese herbal compound.
15822420|NCT04264962|Other|Routine medical care|Routine medical care
15822421|NCT04264949|Other|Education in the use of smartphone app (Mon coach dos)|In addition to conventional care and the therapeutic education program, GA will benefit from three education sessions (one per week) on the use of the smartphone app mon coach dos
15822422|NCT04264949|Other|conventional care|conventional care and the therapeutic education program
15822423|NCT04264936|Drug|RC48-ADC and JS001|Recombinant Humanized anti-HER2(Human epidermal growth factor receptor-2) Monoclonal Antibody-MMAE(Monomethyl Auristatin E) Conjugate For Injection and JS001 Injection
15822424|NCT04264923|Other|HyGIeaCare Prep|Each patient will have up to 5 stool specimens for evaluation by a lab for microbial contents.
15822425|NCT04264910|Behavioral|Calm App|Calm is a subscription-based meditation app which provides guided meditations, sleep stories, soundscapes and calming music. Calm offers 7 Days of Calm for those new to meditation, the daily Calm, a meditation posted daily and a library of unique 10-12 minute meditations with topics related to acceptance, anxiety, self-compassion, and physical pain (to name a few).
15822426|NCT04264897|Drug|Metformin|"Metformin (Hunter Pharmacy) following a ramp up dosing protocol with a targeted dose of 1500 mg/day for 12 weeks."
15822427|NCT04264897|Drug|Placebo oral tablet|Silicified microcrystalline cellulose, Micosolle®, K30 povidone, sodium starch glycolate, and magnesium stearate
15822428|NCT04264884|Drug|Daratumumab|Daratumumab 1800 milligram (mg) will be administered as a fixed dose by subcutaneous (SC) injection.
15822429|NCT04264858|Drug|Immunoglobulin of cured patients|0.2g/kg, ivdrip, once a day, for 3 days
15822430|NCT04264858|Drug|γ-Globulin|0.2g/kg, ivdrip, once a day, for 3 days
15822628|NCT04263077|Other|75% TENSION GROUP|Kinesiotape will be applied to the lateral epicondyle region with 75% tension.
15822431|NCT04264845|Other|Provider Focus|The provider focus groups will be conducted and data from the focus group sessions will be analyzed and used to evaluate clinicians' interpretation of PROs and acceptability of PRO data in routine clinical care. A formal provider training program will be designed and implemented by a subject matter expert. The focus group session will be repeated at 12 months, with the 12month administration having an increased emphasis on barriers, facilitators, and value of PROs in clinical care.
15822432|NCT04264845|Other|Patient Interview|A trained professional interviewer will conduct a one-time, one-hour, semi-structured telephone interview of each subject to better understand patient experiences with HF, the treatment process and quality of life determinants. Two semistructured interviews will be conducted with the first 30 patients who have had LVAD therapy (of the 100 patients who agreed to be interviewed), before and 12 months after device implantation. The goal of these interviews will be to describe patient experiences with LVAD therapy, examine factors influencing quality of life, and determine whether currently available PRO tools are likely to capture the intended experiences in HF as they relate to LVAD therapy.
15822433|NCT04264845|Other|PROs/Clinical Data Integration|A plan has been developed that will integrate PRO scores into patient medical records. Information will be obtained from 2 instruments (KCCQ12 and NIH PROMIS) that are routinely administered as part standard of care. PRO and clinical data will be obtained from electronic medical records of patients seen in the heart failure clinic. All required information will be obtained from the subjects' electronic medical records over a period of 3.5 years after enrollment into the study.
15822434|NCT04264832|Other|Clinical data collection|"Basic characteristics: Participants were carefully characterized with regard to a general health history, a medical history, clinical, demographic and anthropomorphic measurements, skin problems (hirsutism is modified by Ferriman-Gallwey (mF-G) score , global acne score and premature alopecia).
~A transvaginal ultrasound scan was performed on every participant during a clinical examination to determine the number of follicles and ovarian volume.
~Metabolic and other assessments: General gynecological examination, prolactin, thyroid, androgen, LH, FSH, DA, 5-HT, metabonomics, glucose, insulin, triglyceride (TG), LDL and HDL were determined, OGTT was performed.
~Questionnaires: The perceived stress scale(Chinese 14-item PSS), self-rating anxiety scale (SAS）, self-rating depressive scale(SDS) were used to assess the participants' mental health status. The MOS item short from health survey (SF-36) was used to assess the quality of life ."
15822436|NCT04264806|Drug|Azacitidine|Participants will receive subcutaneous (SC) or intravenous (IV) injection of Azacitidine 75 mg/m^2.
15822437|NCT04264806|Drug|Cusatuzumab|Participants will receive SC or IV injection of Cusatuzumab 20 mg/kg.
15822438|NCT04264793|Behavioral|Behavioral Lifestyle Intervention|In addition to usual care in the health center, the intervention included 7 visits with the health center dietitian for individual nutrition counseling, invitation for group nutrition education (5 sessions), individual counseling for physical activity, invitation for a 6-weekly structured group physical activity, DVD on physical activity to perform physical activity at home.
15822439|NCT04264793|Behavioral|Usual Care|Patients received usual care including education as part of the diabetes management from their healthcare professionals (physicians and nurses), normally every 2-3 months. Visits with the health center dietitian were arranged as per physician referral.
15822440|NCT04264780|Other|Neuropsychological examination|Neuropsychological follow-up examination, including questionaires
15822441|NCT04264767|Procedure|Blood collection|Peripheral blood collection via routine venipuncture
15822442|NCT04264754|Procedure|Blood collection|Peripheral blood will be collected via routine venipuncture procedure
15822443|NCT04264741|Device|repetitive transcranial magnetic stimulation (rTMS)|The iTBS group received 900 pulses per day: 3-pulse 50-Hz bursts given every 200 ms (at 5 Hz), 2 s on and 8 s off for 5 min, at 100% resting motor threshold (rMT), over the left DLPFC (F3, EEG system) (4 weeks, 20 daily sessions). A figure-8-shaped Cool-B70 stimulation coil from MagPro X100 device (MagVenture, Farum, Denmark) was used for accurately targeted stimulation. Motor threshold was determined over the left motor cortex, by finding the lowest intensity that produced a motor response in the right abductor pollicis brevis muscles (APB), which produced five motor-evoked potentials responses of at least 50 mV in 10 trials.
15822444|NCT04264741|Device|sham repetitive transcranial magnetic stimulation (rTMS)|The iTBS group received 900 pulses per day: 3-pulse 50-Hz bursts given every 200 ms (at 5 Hz), 2 s on and 8 s off for 5 min, at 100% resting motor threshold (rMT), over the left DLPFC (F3, EEG system) (4 weeks, 20 daily sessions). A figure-8-shaped sham Cool-B70 stimulation coil from MagPro X100 device (MagVenture, Farum, Denmark) was used for accurately targeted stimulation. Motor threshold was determined over the left motor cortex, by finding the lowest intensity that produced a motor response in the right abductor pollicis brevis muscles (APB), which produced five motor-evoked potentials responses of at least 50 mV in 10 trials.
15822445|NCT04264715|Device|405nm light|In this room, surgeries will be performed under ambient light including the wavelength 405nm
15822446|NCT04264689|Procedure|serratus anterior block|ultrasound guided block
15822447|NCT04264689|Procedure|thoracic epidural|thoracic epidural
15822448|NCT04264689|Procedure|erector spinae block|ultrasound guided block
15822449|NCT04264676|Drug|Metronidazole Oral Tablet|Supplement of metronidazole 0.4g three times per day for 7 days before each two cycles of chemotherapy (mFOLFOX6 once every 4 weeks, CapeOX once every 6 weeks), which is 6 treatments for mFOLFOX6 and 4 treatments for CapeOX totally.
15822450|NCT04264676|Drug|Placebo oral tablet|Supplement of placebo oral tablet 0.4g three times per day for 7 days before each two cycles of chemotherapy (mFOLFOX6 once every 4 weeks, CapeOX once every 6 weeks), which is 6 treatments for mFOLFOX6 and 4 treatments for CapeOX totally.
15822451|NCT04264663|Drug|Furazolidone|Furazolidone-tetracycline-containing quadruple regimens
15822452|NCT04264663|Drug|Tinidazole|tinidazole-tetracycline-containing quadruple regimens
15822453|NCT04264650|Behavioral|an mHealth intervention|The Care & Organize Our Lifestyle (COOL) program, a self-regulation theory-based mHealth program
15822454|NCT04264637|Drug|Azelastine hydrochloride (BAYR9258)|Single dose, metered-spray solution, 2 sprays per nostril, 205.5 mcg/spray, intranasal administration.
15822629|NCT04263077|Other|100% TENSION GROUP|Kinesiotape will be applied to the lateral epicondyle region with 100% tension.
15822455|NCT04264637|Drug|Placebo|Single dose of Azelastine hydrochloride-matched placebo, metered-spray solution, 2 sprays per nostril, intranasal administration.
15822456|NCT04264624|Device|Perioflow and Erythritol powder and ultrasonic debridement|Airflow and Perioflow combined with Erythritol powder will be used as an adjunct therapy
15822457|NCT04264624|Device|Airflow and Erythritol powder and ultrasonic debridement|Airflow combined with Erythritol powder will be used as an adjunct therapy
15822458|NCT04264611|Other|Experimental: Short Foot Exercise Group|Short foot exercise which was performed under the supervision of physiotherapist for four weeks in 30 repetitions five days a week.
15822459|NCT04264611|Other|Experimental: Towel Curl Exercise Group|Towel curl exercise which was performed under the supervision of physiotherapist for four weeks in 30 repetitions five days a week.
15822460|NCT04264598|Biological|sIPV|The Medium dosage sIPV was developed by Minhai Biotech Co., LTD. The antigen contents of type I, type II and type III polioviruses in the medium dosage sIPV were 15 DU, 45 DU and 45 DU. The vaccine was in liquid form, 0.5 ml per dose.
15822461|NCT04264598|Biological|Commercialized sIPV|The commercialized sIPV was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.The antigen contents of type I, type II and type III polioviruses in the commercialized sIPV were 30 DU, 32 DU and 45 DU. The vaccine was in liquid form, 0.5 ml per dose.
15822462|NCT04264598|Biological|Commercialized IPV|The commercialized Salk IPV was manufactured by Sanofi Pasteur S.A.The antigen contents of type I, type II and type III polioviruses in the commercialized IPV were 40 DU, 8 DU and 32 DU. The vaccine was in liquid form, 0.5 ml per dose.
15822463|NCT04264585|Behavioral|Internet-delivered cognitive behaviour therapy|All clients will receive the same materials, namely the UniWellbeing Course, which was developed at Macquarie University, Australia. The UniWellbeing Course is a transdiagnostic intervention targeting symptoms of depression and anxiety, that has been tailored for use in post-secondary students. It comprises 4 online lessons that provide psychoeducation about: symptom identification and the cognitive behavioural model; thought monitoring and challenging; de-arousal strategies and pleasant activity scheduling; graduated exposure; and relapse prevention. Seven supplementary lessons can also be accessed at any time (e.g., sleep, communication). Materials are presented in a didactic (i.e., text-based with visual images) and case-enhanced learning format (i.e., educational stories demonstrate the application of skills) with 4 lesson summaries and homework assignments that facilitate skill acquisition. Therapists will spend ~15 mins. per week/per client.
15822464|NCT04264585|Behavioral|Motivational Interviewing|Clients assigned to the ICBT with Motivational Interviewing condition will receive access to the Planning for Change lesson before accessing Lesson 1. They will be presented with five interactive online exercises based on motivational interviewing principles (i.e. values clarification, importance ruler, looking back, confidence ruler, and looking forward). As clients complete the exercises, they are prompted to answer open-ended questions and are provided with written feedback.
15822465|NCT04264585|Behavioral|Booster Session|"Clients assigned to the ICBT with Booster condition will receive access to a booster session one month after the end of the ICBT course. The booster session will include information about maintaining motivation, a review of the ICBT course content and skills, and information about structured problem solving. Clients will also have access to a Do-It-Yourself guide that summarizes the information in the booster session and includes worksheets for clients to practice the problem-solving skills described in the booster.
~This booster session will be self-guided (ie. no therapist support is offered)."
15822466|NCT04264572|Other|Medically Tailored Meals|MTM are meals designed by a Registered Dietitian Nutritionist to reflect appropriate dietary therapy according to evidence-based nutrition practice guidelines. They address medical diagnoses, symptoms, allergies, inability to chew or swallow, medication management, and side effects to ensure the best possible nutrition-related health outcomes.
15822467|NCT04264572|Behavioral|Tele-Medical Nutrition Therapy (tele-MNT)|Medical nutrition therapy (MNT) is offered as a component of usual care in many health systems, and consists of individuals receiving nutrition education tailored to their unique medical needs. Tele-MNT is the use of video technology to deliver MNT.
15822468|NCT04264559|Diagnostic Test|Infrared thermal imaging|A thermal imager is used to record thermal images.The baseline temperature of relevant acupoints or sites on the Heart and Lung meridians will be measured.
15822469|NCT04264559|Procedure|Moxibustion|"Two sessions of moxibustion intervention will be performed in the Heart meridian and Lung meridian successively. During moxibustion, the temperature change of relevant acupoints or sites in the Heart and Lung meridians will be measured by infrared thermal imaging.
~Intervention in the Heart meridian: moxibustion will be performed in acupoint HT3 of the Heart meridian for 15 minutes.
~Intervention in the Lung meridian: moxibustion will be performed in acupoint LU5 of the Lung meridian for 15 minutes."
15822470|NCT04264546|Biological|sIPV|The investigational High dosage Sabin IPV was all developed by Minhai Biotech Co., LTD. The antigen contents of type I, type II and type III polioviruses in the high dosage Sabin IPV were 22 DU, 65 DU and 65 DU. The vaccine was in liquid form, 0.5 ml per dose.
15822471|NCT04264533|Drug|VC|12g Vitamin C will be infused in the experimental group twice a day for 7 days by the infusion pump with a speed of 12ml/h.
15822472|NCT04264533|Drug|Sterile Water for Injection|50ml sterile water for injection will be infused in the placebo comparator group twice a day for 7 days by the infusion pump with a speed of 12ml/h.
15822473|NCT04264520|Behavioral|PTSD Psychoeducation + Skills Intervention|A brief computer-assisted intervention (psychoeducation + skills) for pregnant women with elevated PTSD symptoms.
15822474|NCT04264494|Procedure|PRP intra articular injection|Fifty RA patients were injected intra-articularly with 3 doses of PRP at 4 weeks intervals for the joints with only tenderness (arthralgia without swelling or effusion) and revaluated at 3 and 6 months post the last injection regarding the same evaluating tools.
15822475|NCT04264494|Procedure|NACL intra articular injection|and 50 patients who serve as a control and injected intra-articularly with 3 doses of placebo (NaCl saline) at 4 weeks intervals for the joints with only tenderness (arthralgia without swelling or effusion) and revaluated at 3 and 6months post last injection regarding the same evaluating tools.
15822476|NCT04264481|Procedure|Adductor Canal Block|Ultrasound guided perineural injection of 5cc bupivacaine, 5cc lidocaine and 10 cc Normal saline
15822477|NCT04264481|Procedure|Intra-Articular Steroid and Lignocaine Injection|Intra-articular injection of 40mg triamcinolone and 1-2 cc of lidocaine
15823614|NCT04255342|Other|keratinized mucosa height|keratinized mucosa height
15822478|NCT04264468|Combination Product|neoadjuvant chemotherapy|This study prospectively included 150 breast cancer patients (30 patients in the first stage and 120 patients in the second stage) who were treated with the commonly used neoadjuvant chemotherapy recommended by NCCN, received surgical treatment after neoadjuvant chemotherapy, and evaluated the efficacy according to the surgical pathological response.Based on the Mammaprint technology analysis of patients with pathologic complete response (pCR), partial response and no response, we analyzed the characteristic genes related to breast cancer in the tumor tissues and evaluated the accuracy and sensitivity of the Mammaprint test for the efficacy of neoadjuvant chemotherapy
15822479|NCT04264455|Device|Biomonitor|Patients receive a Biomonitor only
15822480|NCT04264455|Device|Life Vest|Patients receive a Wearable Cardioverter-Defibrillator; a Biomonitor is implanted additionally
15822481|NCT04264455|Device|Implantable Cardioverter-Defibrillator (ICD)|Patients receive an Implantable Cardioverter-Defibrillator (ICD)
15822482|NCT04264442|Drug|Losmapimod|Patients will receive Losmapimod 15 mg by mouth twice daily for a total of 30 mg daily. The study drug should be taken with food and the date and time of each dose taken should be recorded in the subject diary.
15822483|NCT04264429|Device|Infrapatellar strap|Orthotic device which is positioned over the patellar tendon
15822484|NCT04264429|Other|Elastic band|Orthotic device which is positioned over the patellar tendon
15822485|NCT04264416|Device|WB-EMS|16 weeks of WB-EMS
15822486|NCT04264403|Device|Renal denervation|The Paradise® Renal Denervation System (Paradise System) is CE-marked in countries accepting the CE mark. The system is a catheter-based device designed to use ultrasound energy to thermally ablate the afferent and efferent nerves surrounding the renal artery and serving the kidney.
15822488|NCT04264377|Procedure|Bronchoscopy|Bronchoscopy for retrieval of airway cells
15822489|NCT04264364|Procedure|Laparoscopic sleeve gastrectomy|Bariatric surgical intervention
15822490|NCT04264364|Procedure|Endoscopic sleeve gastroplasty|Endoscopic bariatric procedure
15822491|NCT04264338|Diagnostic Test|Thyromental height test|Assessment of difficult airway
15822492|NCT04264325|Other|diaphragmatic ultrasound measure|patients with lung neoplasms and malignant pleural effusions who need a diagnostic or therapeutic thoracocentesis
15822493|NCT04264299|Procedure|T tube drainage|closure of common bile duct over T tube
15822494|NCT04264299|Procedure|Primary closure|Primary closure of common bile duct
15822495|NCT04264299|Procedure|Antegrade stenting|Closure of common bile duct over antegrade plastic biliary stent
15822496|NCT04264286|Drug|Prophylactic esmolol|Patients will receive prophylactic esmolol after the end of the surgery
15822497|NCT04264286|Drug|Placebo|Patients will prophylactic placebo after the end of the surgery
15822498|NCT04264260|Drug|Colchicine Tablets|three times or two times per day after meal with the daily total dose ranging from 1.5 to 3 mg
15822499|NCT04264247|Diagnostic Test|routine fetal ultrasonography at 11-14 weeks|routine fetal ultrasonography at 11-14 weeks
15822500|NCT04264234|Diagnostic Test|Vaginal Ultrasonography|Placenta previa cases will be evaluated at 32nd week by vaginal ultrasonography for invasion anomaly and preterm birth.
15822501|NCT04264234|Diagnostic Test|Magnetic Resonance Imaging|Placenta previa cases will be evaluated at 32nd week by MRI for invasion anomaly and preterm birth.
15822502|NCT04264221|Behavioral|New management mode|"New management mode intervention: Pharmaceutical care
~SMS text messages and Phone Calls
~Behavioural Educational leaflet
~Self-Administered Therapy A financial incentive for mobile use"
15822503|NCT04264208|Drug|68-Ga RM2.|PET radiopharmaceutical
15822504|NCT04264208|Drug|68-Ga PSMA11|PET radiopharmaceutical
15822505|NCT04264208|Device|PET/MRI|PET/MR scanner by GE healthcare
15822506|NCT04264195|Other|Constraint-induced movement therapy: PEPS-MIT|"All participants of control and experimental groups received standard stroke rehabilitation. After regular office time, a 2 hours' peer group session was provided, 5 days/week, 4 consecutive weeks, to both groups. One patient 'leads' the group exercises under a therapist's supervision. The therapist is mainly helping and correcting patients during the various exercise tasks.
~• Specific for the experimental group was that patients performed all manipulation tasks with forced use of the paretic hand/arm by wearing a soft-padded mitten at the non-paretic hand, preventing manipulation with that hand. Patients were encouraged to wear the mitten also for 3 hours/day at home, while performing ADL and learned exercises. Behavioural strategies included a treatment contract and daily use of the home activity checklist which was checked by patient's caregiver and signed by both patient and caregiver. Each treatment day the activity checklist was submitted to the therapist who gives feedback."
15822507|NCT04264195|Other|Bimanual manipulation exercises (PEPS-Bimanual)|"All participants of control and experimental groups received standard stroke. After regular office time, a 2 hours' peer group session was provided, 5 days/week, 4 consecutive weeks, to both groups. One patient 'leads' the group exercises under a therapist's supervision. The therapist is mainly helping and correcting patients during the various exercise tasks.
~Specific for the control group was that patients performed all manipulation tasks bimanually, as they used to do in occupational therapy activities. Patients were also asked to document their 'at home' activities in an activity checklist that was regularly checked by the therapists."
15822508|NCT04264182|Other|ICD programming|Re-programming of the ICD device for VA detection (see above)
15822509|NCT04264156|Combination Product|Lucinactant for Inhalation|A drug-device combination product that delivers aerosolized SRT to preterm neonates with RDS who are being supported with nCPAP.
15822510|NCT04264156|Other|nCPAP Only|Nasal CPAP Alone
15822511|NCT04264143|Drug|Infusate with MTX110 and gadolinium|Pulses 1 and 2 will be prepared with 30, 60 or 90 uM concentration of MTX110. The infusate consists of gadolinium and MTX110 (30, 60, or 90 uM) at approximately 1:100 ratio.
15822512|NCT04264143|Device|Convection-Enhanced Delivery (CED)|CED is the method by which the drug are delivered to the brain under controlled pressure to the brain by targeted micro-catheters.
15822513|NCT04264130|Drug|Artesunate-Pyronaridine|Subjects received artesunate-pyronaridine according to their body weight once per day for three days.
15822514|NCT04264130|Drug|Artemether-Lumefantrine|subjects received artemether-lumefantrine according to their body weight twice per day for three days.
15822515|NCT04264130|Drug|Artefenomel-Ferroquine|Subject received a single dose of artefenomel-ferroquine according to their body weight
15822516|NCT04264117|Procedure|FlexAbility (Mesh-like irrigated tip catheter) group|"AF catheter ablation (PV isolation and linear ablations)
~30 sec ablation in each point
~35W in anterior LA, 30 W in posterior LA
~Irrigation flow rate 13mL/min
~Measuring procedure time, Ablation time
~Rhythm follow-up based on guidelines"
15822517|NCT04264117|Procedure|TactiCath (Contract force monitoring catheter) group|"AF catheter ablation (PV isolation and linear ablations)
~contact force >10g, target force-time integral 400 in each point
~35W in anterior LA, 30 W in posterior LA
~Irrigation flow rate 15mL/min at 30W ablation, 30mL/min at 35W ablation
~Measuring procedure time, Ablation time
~Rhythm follow-up based on guidelines"
15822518|NCT04264104|Other|neural mobilization|This is a type of mobilization that uses a specific combination of joint movements
15822519|NCT04264091|Other|Observational|Observational
15822520|NCT04264078|Biological|CD7 UCAR-T cells|Dose range:1 to 5 ×10^7 cells/Kg, Dose level one: 1×10^7 cells/Kg, Dose level two: 3×10^7 cells/Kg, Dose level three:5 ×10^7 cells/Kg
15822521|NCT04264078|Drug|Fludarabine|30mg/m^2 per day for 6 days
15822522|NCT04264078|Drug|Cytoxan|600mg/m^2 per day for 2 to 6 days determined by tumor burden at baseline
15822523|NCT04264078|Drug|Melphalan|50 to 70 mg/m^2 in total for 1 or 2 days, whether to use determined by tumor burden at baseline
15822524|NCT04264052|Diagnostic Test|CBE & MRIE|"The diagnostic tests will be consisted by two visits.
~In the first visit participants will undergo a medical history assessment and they will complete questionnaires related to the lung function (MRC Dyspnoea score, Dyspnoea-12 questionnaire, and Visual Analogue Scale). A spirometry will be performed to assess the lung function. Bronchoscopy will be performed at rest in a semi-supine position (on a reclined bed) and then during exercise on a treadmill.
~In the second visit, spirometry and questionnaires will be performed prior to resting and during exercise measurements on a magnetic resonance imaging (MRI) scan.
~Rest: Structural imaging of the neck and chest will be performed followed by dynamic imaging of the airways during several inspiratory and expiratory manoeuvres. No IV contrast media will be used.
~Exercise: After obtaining the baseline images, the participants will be asked to cycle using a programmable supine ergometer placed on the MRI."
15822525|NCT04264039|Biological|anti-CD19 UCAR-T cells|Dose range:1 to 5 ×10^7 cells/Kg, Dose level one: 1×10^7 cells/Kg, Dose level two: 3×10^7 cells/Kg, Dose level three:5 ×10^7 cells/Kg
15822526|NCT04264039|Drug|Fludarabine|30mg/m^2 per day for 6 days
15822527|NCT04264039|Drug|Cytoxan|300mg/m^2 per day for 2 to 6 days determined by tumor burden at baseline
15822528|NCT04264039|Drug|Melphalan|50 to 70 mg/m^2 in total for 1 or 2 days, whether to use determined by tumor burden at baseline
15822529|NCT04264026|Drug|3,4-methylenedioxymethamphetamine|Bottles are labeled with a unique container number, protocol number, IMP name, lot number, sponsor name and a statement that the IMP is restricted to clinical trial use only.
15822530|NCT04264013|Behavioral|Exercise|Participants will exercise in a supervised facility twice weekly and consume their habitual diet.
15822531|NCT04264013|Behavioral|Exercise plus diet (egg)|Participants will exercise in a supervised facility twice weekly and consume an addiitonal 4 eggs per day.
15822532|NCT04264000|Drug|platelet-rich plasma|Ultrasound-guided 3cc PRP injection between medial epicondyle and ulnar nerve
15822533|NCT04264000|Drug|5% dextrose|Ultrasound-guided 3cc 5% dextrose injection between medial epicondyle and ulnar nerve
15822534|NCT04263987|Procedure|Moses laser enucleation of prostate|Using the moses settings with the Lumenis laser system to evaluate outcomes for enucleation of the prostate; hypothesis is that it leads to faster operative time
15822535|NCT04263974|Other|Smartphone Application|Exercises and recommendations, based on current scientific evidence, and delivered through the app for Smartphone called CareHand. The intervention protocol is based on strengthening and stretching recommendations for rheumatoid arthritis and osteoarthritis in hands, transferred to an application format through explanatory videos together with tools to improve the autonomy, motivation and adherence of the patient
15822536|NCT04263974|Other|Conventional treatment|Conventional approach provided by the Andalusian Public Health System in Primary Care settings. This approach consists of routine visits to the general practitioner specialist, and the delivery of an exercise sheet and recommendations. This general mobility and stretching worksheet contains detailed images, as well as a description of how to perform the exercises and the dose to be taken. While most exercises are intended for the wrist and hands, this sheet also includes basic exercises for the elbow joint.
15822537|NCT04263948|Device|Picado Monitoring plateform|The device will monitor the rhythms, symptoms and body weight of patients with advanced pancreatic cancer during the month following the 1st cycle of FOLFIRINOX in conventional administration using the platform
15822538|NCT04263922|Drug|Huaiqihuang granules|Huaiqihuang granules, 2 bags at a time, 3 times a day. Valsartan capsule simulant, 80mg at a time, once a day. Oral administration.
15822539|NCT04263922|Drug|Valsartan capsule|Valsartan capsule, 80mg at a time, once a day. Huaiqihuang granules simulant, 2 bags at a time, 3 times a day. Oral administration.
15822540|NCT04263909|Drug|Sublingual Tablet|sufentanil SL 30mcg administered sublingually to patients undergoing spine surgery before extubation and during recovery
15822565|NCT04263610|Drug|Dimethyl fumarate (DMF) standard scheme|Participants will receive DMF gastro-resistant tablet orally from baseline to Week 16, at a dose of 30 milligrams (mg) once daily, twice daily, thrice daily in Week 1, Week 2, Week 3 respectively, 120 mg only once in Week 4. Participants will increase DMF dose by 120 mg tablet per week for the subsequent 5 weeks. Participants achieving Psoriasis area and severity Index (PASI) 50-75 (partial responder) or 75 (responder) will continue the DMF treatment until Week 40. The maximum daily dose taken by a participant will be 720 mg.
15822735|NCT04262336|Drug|Placebo|Injectable sterile viscous solution of sodium hyaluronate in sodium chloride
15822542|NCT04263883|Device|Study or Experimental Group|3D PCO to make mirror image therapy (reverse posture training) during the patient walking on motorized treadmill, This way of functional training will deliver via the use of the adjustable cervicothoracic orthosis during the patient walking at approximately 2-3 miles per hour on a standard, motorized treadmill. The brace will reverse the abnormal posture according to the 3D posture analysis data. To facilitate tissue remodeling by reverse posture training, this called mirror image traction.then the ambulatory exercises by using treadmill will be performed while the patient's mirror image posture will be held by the adjustable orthosis, ambulatory exercises for 20 minutes by using treadmill based on Harrison et al., approach, this program will be repeated 2-3 times /week for 10weeks.
15822543|NCT04263870|Drug|sintilimab|oral capecitabine 1000mg per m2 bid d1-14, intravenous oxaliplatin 130mg d1 per m2, sintilimab 200mg (every 3 weeks)
15822544|NCT04263844|Drug|Intranasal dexmedetomidine|subject will receive premedication with intranasal dexmedetomidine thirty minutes before induction
15822545|NCT04263844|Drug|Intranasal Midazolam|subject will receive premedication with intranasal midazolam thirty minutes before induction
15822546|NCT04263831|Drug|Interleukin-2 (aldesleukin).|"Description of intervention is covered in Arm, above."
15822547|NCT04263818|Procedure|Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for|"Carrying out the endoscopic procedure planned for the patient with the dedicated colonoscope which has magnetic coils over the entire length of the insertion tube. These magnetic coils generate a pulsed magnetic field at low frequency. These pulses are transmitted to an external receiver, refreshed at 15 images per second, then relayed to the processor to generate a 3D representation of the colonoscope next to it of the endoscopic image. There is no additional risk to the patient compared to current practice.
~Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for."
15822548|NCT04263805|Other|Vignette with emphasis on research climate|A vignette describing a dilemma situation for a researcher (e.g. adding an honorary author) with or without a research environment factor (i.e. an environment where other researchers commit detrimental research practice)
15822549|NCT04263792|Drug|[18F]fluoropropyl-trimethoprim|[18F]Fluoropropyl-Trimethoprim, also known as [18F]F-TMP, is a radiolabeled imaging agent for positron emission tomography (PET/CT).The use most relevant to this protocol is for imaging bacterial infection in human subjects. The parent compound, trimethoprim (TMP) is a well-known, safe, broad-spectrum, synthetic, small molecule antibiotic that has been used clinically for over 50 years for the treatment of acute bacterial infection and has been combined with sulfa-based antibiotics (Bactrim/Septra) for bacterial infection prophylaxis especially in the lung and bladder. An immediate clinical use for TMP radiotracers is imaging of pathologic bacteria that are the cause of human infection.
15822550|NCT04263779|Behavioral|Order of Options|Relevant providers who are part of the Geisinger preferred provider network will be presented at the top of the otherwise ranked list of SNFs.
15822551|NCT04263779|Behavioral|Default Option|Both the list and the map will present only the P-SNFs, with a button allowing patients to view all results only if they opt to do so. The optional P-SNF advantage video will be included and the link to it highlighted.
15822552|NCT04263766|Other|Transcranial magnetic stimulation|TMS will be delivered to different brain areas in order to establish their contribution to visual metacognition.
15822553|NCT04263753|Procedure|Bladder conservative surgery in placenta accretta|"After control of both superior vesical vessels Finding a fresh noninvaded plan between isthmocervical junction and posterior bladder wall aided by filling the bladder 150 cc saline Then cervical stump control sutures and severing the specimen above the clamps
~* Now the placenta is only attached to the bladder , apply intestinal clamp or foley cath on the bladder below the level of invasion if feasible to reduce bleeding
~* cut through the placenta, heavy back flow bleeding of old blood stored in the placenta will be noticed , but there is no hemodynamic change since the cervical stump is already severed
~, dissect the bladder with a large safety margin cutting through the placenta.. Then in cases with hematuria saline irrigation of the bladder is usually enough to clear the hematuria 15 out of 20"
15822554|NCT04263740|Procedure|Kinesio Taping|Taping for 3 days every week and two sessions of PT twice a week. The PI also instructed the patient to inform him if the tape gets off or become loose. KT was removed after 72 hours, and then reapplied after a few days rest to allow the skin to recover and to avoid skin irritation. The patient was instructed to refrain from getting the tape wet for 30 to 45 minutes after application to allow for better adherence. Patients were also instructed to be careful during dressing and undressing so the tape does not get caught with their clothes if the edges of the tape get slightly loose. No physical therapy treatment or taping was provided during the rest period except for the prescribed home exercise program. Patients in both groups received the same traditional physical therapy treatment two times a week.
15822555|NCT04263740|Procedure|Traditional Physical therapy|Traditional physical therapy was in the form of patient education, manual therapy and therapeutic exercises. Patient education focused on the natural history of the condition and its favorable prognosis, positive thinking, and encouragement of activity participation. Patient education was delivered through one-on-one discussion by the principal investigator.
15822556|NCT04263714|Behavioral|Exercise|Aerobic exercise and resistance exercise
15822557|NCT04263701|Other|Therapeutic exercises|Conventional physiotherapy exercises for children with cerebral palsy
15822558|NCT04263701|Other|Dual Task Training|Dual task training in addition to conventional physiotherapy exercises for children with cerebral palsy
15822559|NCT04263688|Other|Non-Intervention|Non-Intervention
15822560|NCT04263662|Other|Analgesia-Sedation algorithm|The analgesia-sedation algorithm is a suggested protocol for approach to providing analgesia and sedation to patients admitted to the pediatric ICU who are newly intubated. The approach focuses on using dexmedetomidine as the primary sedative, non-opioids as the primary analgesia, then stepwise approach to adding in adjunctives (e.g. opioids, non-benzodiazepines) with the intention of minimizing benzodiazepine exposure and utilizing minimal-dose effective analgesia/sedative dosing.
15822561|NCT04263649|Device|Peripherally Inserted Central Catheter|insertion of a Peripherally Inserted Central Catheter (PICC)
15822562|NCT04263636|Procedure|Phacoemulsification with bilateral trifocal diffractive IOLs|Uneventful bilateral pseudophakic presbyopic correction with trifocal diffractive IOLs
15822563|NCT04263623|Drug|Dexmecamylamine HCl|Investigational drug
15822564|NCT04263623|Other|Placebo|Oral tablet containing no active drug.
15823615|NCT04255342|Other|plaque index|plaque index
15822566|NCT04263610|Drug|Dimethyl fumarate (DMF) simplified scheme|Participants will receive DMF gastro-resistant tablet orally at a dose of 60, 120, 180, 240, 360 mg daily in Week 1, Week 2, Week 3, Week 4, Week 5 respectively, and 480 mg daily from Week 6 to Week 8. If a PASI is greater than or equal to (>=) 30% at Week 8, no dose increase will be done and if PASI is less than (<) 30% at Week 8, participants will receive 600 mg daily in Week 9 and 720 mg from the Week 10 onwards.
15822567|NCT04263610|Drug|Tildrakizumab|Participants who achieve PASI less than (<) 50 (non-responders) at Week 16 will receive Tildrakizumab subcutaneous injection at a dose of either 100 or 200 mg [(as per the Summary of Product Characteristics (SmPC)] at Weeks 16, 20 and 32 up to Week 40.
15822568|NCT04263597|Drug|2'-fucosyllactose|2FL powder will be provided to participants randomized to receive 2FL in packets. They will be instructed to drink this daily by adding the required amount to food or drink. It may also be mixed in standard feeds or mixed with water and administered by enteral tube, whenever applicable.
15822569|NCT04263597|Other|Placebo (2g oral glucose)|2g oral glucose will be given to participants randomized to receive placebo.
15822572|NCT04263558|Behavioral|Emotion child|The MFS will include an idiographic measure of personal aims, symptom burden, displayed on a visual data dashboard to guide further intervention. The EMOTION intervention for children 9 to 12 years with symptoms of anxiety and/or depression will be used in a standard/long version (16 sessions) and a short (8 sessions) but optimized version, using a partial web-based solution with virtual reality (VR)-technology for behavioral experiments and exposure (in short and long version). Parental involvement: Parental participation in a 5-session parent group (high involvement) versus sharing information with parents via a brochure (low Parental involvement).
15822573|NCT04263545|Behavioral|Group session with smoking cessation counsellor|Group session with smoking cessation counsellor
15822574|NCT04263545|Behavioral|Standard Care|standard care arm will receive very brief advice (VBA) and signposting to local organisations to support a quit.
15822575|NCT04263519|Drug|Tacrolimus|Oral Immunosuppressant
15822576|NCT04263506|Other|Vignette with emphasis on supervisor's opinion|A vignette describing a dilemma situation for a researcher (e.g. adding an honorary author) with or without the description of supervisor's advice that does not oppose to detrimental research practice (i.e. the supervisor is fine with whatever the PhD student decides in the dilemma).
15822577|NCT04263493|Other|Rehabilitation (physiotheraphy)|Time of loading, range of motion exercises, strength training
15822578|NCT04263480|Drug|Carfilzomib + Ibrutinib|"Ibrutinib:
~Continuous treatment:
~420 mg p.o. daily, until evidence of progressive disease or no longer tolerated.
~Carfilzomib:
~Cycle 1 (day 1-28):
~20mg/m2 i.v. day 1; 70 mg/m2 i.v. day 8, 15 of a 28 days cycle
~Cycle 2-12 (28 day cycles):
~70mg/m2 i.v. day 1, 8, 15 of a 28 days cycle
~Cycle 13-24 (28 day cycles):
~70mg/m2 i.v. day 1,15 of a 28 days cycle"
15822579|NCT04263480|Drug|Ibrutinib|"Ibrutinib:
~Continuous treatment:
~420 mg p.o. daily, until evidence of progressive disease or no longer tolerated by the subject."
15822580|NCT04263467|Other|Exercise intervention|The exercise intervention will consist a intermediate to high aerobic exercise training program.
15822581|NCT04263467|Other|Standard oncological treatments|Standard oncological treatments
15822582|NCT04263454|Drug|Endotoxin, Escherichia Coli|Endotoxin is a purified lipopolysaccharide prepared from E. coli O:113 and vialed under good manufacturing practice guidelines.
15822583|NCT04263454|Procedure|Magnetic Resonance Spectroscopy|MRI is a non-invasive imaging technique and does not utilize ionizing radiation.
15822584|NCT04263441|Behavioral|NICE Intervention|Subjects enrolled in the intervention arm will be offered assistance in enrolling in healthcare coverage and provided assistance on where they can go for care immediately. Subjects will be followed for 1 year and information including lab tests and insurance coverage status will be collected. This information will be collected from medical record review.
15822585|NCT04263428|Behavioral|Irregular sleep|Experimental-induced sleep variability
15822586|NCT04263415|Drug|Semaglutide|semaglutide inrun period of 4 weeks with 0.5mg/week s.c. followed by 1mg/week sc for 12 weeks
15822587|NCT04263415|Other|Placebo|once-weekly injection with placebo pen for 16 weeks
15822588|NCT04263402|Drug|Methylprednisolone|Patients in the Group I will receive basic symptomatic supportive treatment,plus methylprednisolone(<40mg/d intravenous drip for 7 days).
15822589|NCT04263402|Drug|Methylprednisolone|Patients in the Group II will receive basic symptomatic supportive treatment,plus methylprednisolone(40~80mg/d intravenous drip for 7 days).
15822590|NCT04263363|Drug|Sugammadex 100 MG/ML [Bridion]|Sugammadex administered to patients within the clinical best practice pathway.
15822591|NCT04263350|Drug|Atazanavir/Cobicistat|Fixed dose combination mini-tablet, oral administration
15822592|NCT04263350|Drug|Atazanavir|Powder, oral administration
15822593|NCT04263350|Drug|Cobicistat|Tablet, oral administration
15822594|NCT04263337|Drug|[11C] PiB|Per study protocol static PET images will be acquired after IV infusion of CPiB to generate standard uptake values (SUVs). PET imaging is necessary in order to address the primary and secondary outcome measures as a component of neurological health (i.e., presence of proteinopathies empirically associated with neurodegenerative disease, cognitive decline, and neurological signs/symptoms). All groups will participate in this portion of the protocol.
15822595|NCT04263337|Drug|[18F] PBR111|Per study protocol static PET images will be acquired after IV infusion of F-PBR111 to generate standard uptake values (SUVs). PET imaging is necessary in order to address the primary and secondary outcome measures as a component of neurological health (i.e., presence of proteinopathies empirically associated with neurodegenerative disease, cognitive decline, and neurological signs/symptoms). All groups will participate in this portion of the protocol.
15822596|NCT04263337|Drug|[18F] Flortaucipir|Per study protocol static PET images will be acquired after IV infusion of F-T807 to generate standard uptake values (SUVs). PET imaging is necessary in order to address the primary and secondary outcome measures as a component of neurological health (i.e., presence of proteinopathies empirically associated with neurodegenerative disease, cognitive decline, and neurological signs/symptoms). All groups will participate in this portion of the protocol.
15822597|NCT04263324|Behavioral|Self-hypnosis/self-care|Learning phase of self-hypnosis/self-care.
15822627|NCT04263077|Other|50% TENSION GROUP|Kinesiotape will be applied to the lateral epicondyle region with 50% tension.
15822598|NCT04263311|Behavioral|CHW|Participants will undergo 5 group-based health education sessions on hypertension and diabetes management and provide culturally and linguistically tailored health information and resources There will be 2 one-on-one in-person meetings and up to 7 follow-up calls/meetings to engage in goal-setting activities regarding changes to health behaviors, medication adherence, or other issues related to diabetes prevention as identified jointly by patient and CHW. Participants will develop with the CHW and receive a copy of their long-term and short-term Participant Action Plan. Referrals to other services available in the community (i.e. exercise classes, social services, mental health, tobacco cessation, etc.
15822599|NCT04263298|Drug|Fulvestrant|Fulvestrant 500mg Days 0, 14, 28, then every 28 days
15822600|NCT04263298|Drug|Capecitabine Oral Product|Capecitabine 2000mg/m2 twice daily x 14 days followed by 7 days off
15822601|NCT04263285|Device|rTMS|The study team will deliver rTMS five days a week for four weeks, according to a specific and approved protocol for participant positioning, motor threshold determination, and dosing.
15822602|NCT04263272|Other|Upper Body Circuit Training Program|16 week seated upper body exercise for persons with Spinal Cord Injuries. Participants will attend 2-3 exercise sessions a week, sessions have a mix of SCI community members and inpatients.
15822603|NCT04263259|Behavioral|Attentional Bias Modification|Mobile-Delivered Cognitive Retraining Intervention
15822604|NCT04263246|Dietary Supplement|PhytoDyNAmic|PhytoDyNAmic (6 capsules per day)
15822605|NCT04263246|Dietary Supplement|Inulin|Inulin (6 capsules per day)
15822606|NCT04263233|Other|Analysis using descriptive statistics of patient clinical outcomes.|"Evaluation of the following:
~Laboratory values at admission, week 4, and day 90.
~Pre and post blood pressure at week one and week 4.
~Intradialytic hypotension at week one and week 4.
~Ultrafiltration rates at week one, week 4, day 90, day 180, and day 360.
~Target weight defined and achievement in week one and week 4 and changes between week one and week 4.
~Dialysis access type at week one and day 90.
~Hospitalization and mortality rates."
15822607|NCT04263233|Other|Surveys with participants using validated survey tools.|Surveys will assess participants' Symptom index, Quality of Life, Patient Activation as well as satisfaction with the program.
15822608|NCT04263233|Other|Evaluation of the program process including time, costs, referral rates, admission to the program and length of stay.|Data will be collected using tracking tools throughout the program.
15822609|NCT04263220|Device|Industrial passive exoskeleton with a specific value of the torque of the spring for supporting the back|Both exoskeleton types are passive exoskeletons for supporting the back. The goal is to compare the human response to the simulated industrial tasks between the different exoskeleton conditions
15822610|NCT04263220|Other|protocol will be performed without exoskeleton|protocol will be performed without exoskeleton
15822611|NCT04263207|Other|No intervention|No intervention
15822612|NCT04263194|Device|rTMS|25 min of high frequency (20 Hz) repetitive TMS applied at 100% of resting motor threshold (rMT).
15822613|NCT04263194|Device|Sham rTMS|Placebo intervention will consist in the same procedure but using a sham rTMS coil.
15822614|NCT04263181|Procedure|Peripheral blood draw|"All cohorts will have peripheral blood drawn at baseline no more than 4 days prior to the first dose of chemotherapy and must also occur before the first dose of chemotherapy
~Cohort 0 or 1 - peripheral blood draw on Day 2
~Cohorts 0, 2, 3, 4 and 5 - peripheral blood draw on Day 3
~Cohort 0 or 1 - peripheral blood draw on Day 35 (at count recovery)
~Cohorts 0, 2, 3, 4, and 5 - peripheral blood draw on Cycles 2 and 4, Day 28"
15822615|NCT04263181|Procedure|Bone marrow aspirate|"Cohort 0 or 1 - bone marrow aspirate on Day 14
~Cohort 0 or 1 - bone marrow aspirate on Day 35 (at count recovery)
~Cohorts 0, 2, 3, 4, and 5 - bone marrow aspirate on Cycles 2 and 4, Day 28"
15822616|NCT04263181|Procedure|Buccal swab|"Cohort 0 or 1 - buccal swab on Day 35 (at count recovery)
~Cohorts 0, 2, 3, 4, and 5 - buccal swab on Cycle 2 and 4, Day 28"
15822617|NCT04263168|Diagnostic Test|Continuous Glucose monitoring in the perioperative period|All participants will undergo medical and metabolic profiling before surgery at baseline, and during the first two weeks following surgery. Metabolic profiling will take place during a run-in session in the Sheba medical center, that will include (A) A detailed briefing on study design, goals, samples collection and OGTT, as well as home sample-collecting kit distribution (B) Installation of a continuous glucose monitoring system (CGM, Abbott 'freeStyle Libre').
15822618|NCT04263155|Behavioral|The Body Project|The Body Project is a 4-hour dissonance-based program designed to address body image concerns and prevent eating disorders. The curriculum consists of written, verbal, and behavioral exercises that provide participants with the opportunity to voluntarily and publicly critique the appearance ideal.
15822619|NCT04263142|Drug|GSK3640254 Tablet|GSK3640254 tablets will contain mesylate salt with a unit dose of 100 mg (2x100 mg) and will be administered orally.
15822620|NCT04263142|Drug|GSK3640254 Capsule|GSK3640254 capsules will contain mesylate salt with a unit dose of 100 mg (2x100 mg) and will be administered orally.
15822621|NCT04263129|Procedure|Tracheal, carinal or bronchial transplantation using a stented cryopreserved aortic|Radical resection of the lesions was performed using standard surgical techniques. After resection, airway reconstruction was performed using a human cryopreserved (-80°C) aortic allograft, which was not matched by the ABO and leukocyte antigen systems. To prevent airway collapse, a custom-made stent was inserted into the allograft. In patients with proximal lung tumors, the lung-sparing intervention of bronchial transplantation was used.
15822622|NCT04263116|Procedure|Balloon Assisted Maturation|Angioplasty was performed under direct vision with or without the use of a guidewire using a 1 mm larger balloon than the size of the vein. BAM is performed over the whole length of the vein sparing the spatulated end of the vein
15822623|NCT04263103|Other|SJ-RS-WL2015 visual training program software|It is a software with perceptual learning methods for binocular functions
15822624|NCT04263090|Drug|Rigosertib|Rigosertib will be dosed twice a day for 21 consecutive days, followed by 7 days off treatment (each cycle duration: 28 days). Rigosertib escalation will occur with three dose levels (dose D1: 280mg twice daily; dose D2: 560mg qAM, 280mg qPM; dose D3: 560mg twice daily).
15822625|NCT04263090|Drug|Nivolumab|Nivolumab will be dosed once ever 2 weeks (twice per 28-day cycle; standard fixed dose of 240mg).
15822626|NCT04263077|Other|PLACEBO|The diamond shape technique, which is a kinesio tape technique, will be used in the lateral epicondyle region. The ends of the kinesiotapes will be applied tension-free without overlapping.
15823616|NCT04255342|Other|gingival index|gingival index
15822630|NCT04263064|Drug|High Volume-Low Concentration without Clonidine|The control for this study will be a High Volume-Low Concentration (1.5cc/kg of 0.15% ropivacaine and 5mcg/cc epinephrine) caudal block
15822631|NCT04263064|Drug|High Volume-Low Concentration with clonidine|The study intervention will be High Volume-Low Concentration with clonidine (1.5cc/kg of 0.15% ropivacaine, with 1mcg/cc of clonidine and 5mcg/cc epinephrine).
15822632|NCT04263051|Drug|UCPVax + Nivolumab|"UCPVax will be administrated at day 1 of week 1 ; 2 ; 3 ; 5 ; 6 ; 7 and then week 13 and every 2 months until months 12.
~Nivolumab will be administrated at the dose of 480 mg at day 1 and then every 4 weeks until disease progression or unacceptable toxicity according to label.
~At the end of COMBO phase, nivolumab will be continued every 4 weeks for maximum 24 months from the first administration, until disease progression or unacceptable toxicity according to standard of care."
15822633|NCT04263051|Drug|standard chemotherapy|Second line chemotherapy at the choice of the investigator
15822634|NCT04263038|Drug|Rivaroxaban|Anticoagulation
15822635|NCT04263038|Drug|Placebo|Study drug without active agent
15822636|NCT04263025|Biological|Cryopreserved Umbilical Cord Allograft|"CLARIX® CORD 1K (Amniox Medical, Miami, FL) is an umbilical cord allograft processed using the patented CRYOTEK™ process by TissueTech Inc. to devitalize all living cells but retain the natural structural and biological characteristics relevant to this tissue [43]. CLARIX® CORD 1K (6x3 cm in size) will be cut into two longitudinal pieces (1.5 cm in width) and placed circumferentially around each NVB as a nerve wrap during RARP. CLARIX® CORD 1K has been in market since 2013 in the United States as a 361 human cell and tissue-based product (HCT/P) and is aseptically processed in compliance with current Good Tissue Practices (cGTP) as outlined in 21 CFR Part 1271."
15822637|NCT04263025|Procedure|Robot-Assisted Radical Prostatectomy|Robot-Assisted Radical Prostatectomy (RARP) is the most common surgical technique used to treat clinically localized prostate cancer however robot-assisted radical prostatectomy
15822638|NCT04263012|Other|collection of patient data|assess mortality rate, rehospitalization and survival rate of patients after receiving an artificial heart implant
15822639|NCT04262999|Other|effect of sodium valproate on alveolar bone level|Comparative evaluation of bone mineral density and levels of marginal alveolar bone in patients with epilepsy on sodium valproate drug therapy.Comparative evaluation of periodontal parameters in all the patients who are on sodium valproate drug therapy.
15822640|NCT04262999|Other|effect of levetiracetam on alveolar bone level|Comparative evaluation of bone mineral density and levels of marginal alveolar bone in patients with epilepsy on levetiracetam drug therapy.Comparative evaluation of periodontal parameters in all the patients who are on levetiracetam drug therapy.
15822641|NCT04262999|Other|effect of sodium valproate+levetiracetam on alveolar bone level|Comparative evaluation of bone mineral density and levels of marginal alveolar bone in patients with epilepsy on sodium valproate+levetiracetam drug therapy.Comparative evaluation of periodontal parameters in all the patients who are on sodium valproate+ levetiracetam drug therapy.
15822642|NCT04262999|Other|control group|Control group individuals will be systemically healthy.
15822643|NCT04262973|Other|education|six-hour dementia care course
15822644|NCT04262973|Other|education and workshop|six-hour dementia care course, half-day interprofessional education workshop, and interprofessional practice
15822645|NCT04262960|Device|Device: active CPAP|auto-PAP with pressure between 4 and 20 cm H2O will be administered to randomized patients
15822646|NCT04262960|Device|Device: sham-CPAP|The sham-CPAP will be fixed in the lowest pressure (4cmH2) and modified as recommended by Farré et al, with pressure that no greater than 1cm H2O.
15822647|NCT04262947|Device|Near Infrared Vein Imaging|Use of NI vein imaging device for visualization of veins during peripheral IV placement
15822648|NCT04262947|Other|Conventional IV placement|IV placement utilizing conventional methods
15822649|NCT04262934|Drug|Cholecalciferol 100.000 UI administration|One oral Administration - Every month
15822650|NCT04262934|Other|No vitamin D administration|No vitamin D administration
15822651|NCT04262908|Other|Telephone call|Patients who did not return to work after the SL prescribed initially and had an extension of the SL will be called at 4 months postoperatively to collect infomation
15822654|NCT04262882|Behavioral|Multilevel Family Planning Intervention|"The intervention is comprised of community dialogues, or facilitated discussions, aimed to reshape community norms around gender roles, equity, and family size, and critically analyze the social and community influences of family-wealth and poverty with the overall goal of reconstructing individual attitudes and group norms on paths to/definitions of a successful family inclusive of family planning. Dialogues are enhanced to address knowledge, motivation, self-efficacy, and relationship dynamics, tailored to men and women. Sessions include both gender segregated and integrated groups with couples in the community."
15822655|NCT04262882|Behavioral|Time and attention matched control|"This intervention serves as the attention-matched control. The format and delivery will mirror that of the Family Health = Family Wealth intervention (i.e., number, timing, and duration of sessions). The focus of the intervention is on community sanitation and at-home hygiene (hand-washing, food preparation) following an intervention manual that was developed for community groups in Uganda."
15822660|NCT04262856|Drug|Zimberelimab|Zimberelimab is a fully human anti-PD-1 monoclonal antibody
15822661|NCT04262856|Drug|Domvanalimab|Domvanalimab is a humanized monoclonal antibody targeting human TIGIT
15822662|NCT04262856|Drug|Etrumadenant|Etrumadenant is an A2aR and A2bR antagonist
15822663|NCT04262843|Drug|Cyclophosphamide|Given IV
15822664|NCT04262843|Drug|Fludarabine|Given IV
15822665|NCT04262843|Drug|Fludarabine Phosphate|Given IV
15822666|NCT04262843|Biological|Granulocyte Colony-Stimulating Factor|Growth factor therapy
15822667|NCT04262843|Procedure|Hematopoietic Cell Transplantation|Undergo hematopoietic cell transplantation
15822668|NCT04262843|Procedure|Intensity-Modulated Radiation Therapy|Undergo TMLI
15822669|NCT04262843|Drug|Mycophenolate Mofetil|Immunosuppressive therapy
15822670|NCT04262843|Drug|Tacrolimus|Immunosuppressive therapy
15822671|NCT04262830|Diagnostic Test|Cardiac magnetic resonance imaging (MRI)|Cardiac magnetic resonance imaging will be performed to evaluate cardiac remodeling, function, and tissue characteristics
15822672|NCT04262830|Diagnostic Test|Echocardiography|Echocardiography, heart ultrasound, will be performed in conjunction with cardiac MRI.
15822673|NCT04262830|Diagnostic Test|Electrocardiogram|Measuring conduction abnormalities
15822674|NCT04262817|Drug|Nicotine form|participants will receive 36mg/ml nicotine salt and freebase nicotine
15822675|NCT04262817|Other|E-cigarette experimental flavor|Participants will receive menthol and tobacco flavored e-cigarettes
15822676|NCT04262804|Drug|Margetuximab|Margetuximab IV
15822677|NCT04262804|Drug|Trastuzumab|Trastuzumab IV
15822678|NCT04262804|Drug|Chosen Chemotherapy (Capecitabine)|Capecitabine tablet
15822679|NCT04262804|Drug|Chosen Chemotherapy (Vinorelbine )|Vinorelbine IV
15822680|NCT04262804|Drug|Chosen Chemotherapy (Gemcitabine )|Gemcitabine IV
15822683|NCT04262778|Diagnostic Test|electrochemical skin conductance measurement|electrochemical skin conductance measurement
15822684|NCT04262765|Drug|Ramipril, Amlodipine and Atorvastatin|compare the pharmacokinetic of ramipril (and ramiprilat), atorvastatin as atorvastatin calcium trihydrate, amlodipine as amlodipine besilate from reference products given as a multiple dose
15822685|NCT04262752|Device|intermittent colonic exo-peristaltic massage treatment with the MOWOOT medical device|"The MOWOOT massager belt is connected to the desktop device and is the component which is in contact with the subject giving the abdominal massage action.
~The massager belt, which is placed on the user's abdominal area, administers a specific abdominal massage on the ascendant and descendent segments of the colon. This massage emulates the techniques used by professional therapists through a series of pneumatic actuators operating like the movement of a wave transmitting movement through the colon. The type and speed of the massage can usually be regulated by an algorithm that controls the operation from the desktop device.
~For the present clinical trial, time and force will stay fixed on 20 minutes and force 3 (0'6-0'7 bar). Subjects will not be able to choose other massage options. Subjects should use the MOWOOT device once a day for 20 min (1 complete treatment) ideally at the same hour every day for the 4 weeks of the interventional treatment period."
15822686|NCT04262739|Drug|NYH817G|Subject will orally administer NYH817G (15 mg) during the cycles(21 days)
15822687|NCT04262739|Drug|NYH100P|Subject will orally administer NYH100P (100 mg) during the cycles(21 days)
15822688|NCT04262739|Drug|NYH817G and NYH100P|Subject will orally administer NYH817G (15 mg) and NYH100P (100 mg) during the cycles(21 days)
15822689|NCT04262726|Behavioral|REMOTION|REMOTION is an internet-based intervention aimed at transdiagnostically reducing symptom severity and improving emotion regulation of psychotherapy patients. The structure of REMOTION is based on the idea of an extended process model of emotion regulation as postulated by J.J. Gross (2015). The program includes the following modules: introduction, psychoeducation, identification, selection, implementation and monitoring/modification. A variety of elements based on different psychotherapy approaches (Cognitive Behavioral Therapy, Emotion Focused Therapy, Dialectical Behavior Therapy etc.) are integrated in the program. Participants should work through one module per week. REMOTION is administered as an add-on to treatment as usual (TAU), which is psychotherapy at the outpatient clinic of the Department of Clinical Psychology and Psychotherapy at the University of Bern.
15822690|NCT04262726|Behavioral|TAU|Treatment as usual (TAU) refers to psychotherapy at the outpatient clinic of the Department of Clinical Psychology and Psychotherapy at the University of Bern. Psychotherapy at the outpatient clinic is based on Psychological Therapy (Grawe, 1998) principles, which are largely rooted in academic psychology and which mainly draw on interventions from Cognitive Behavior Therapy. Individual case conceptualization are key in Psychological Therapy, along with general therapeutic factors and a focus on the therapeutic relationship.
15822691|NCT04262713|Other|Radiographs|Radiographs of the implanted hip with Meije duo size1 or 2 are performed in eligible patients ( Weigh>60, Long neck stem, Varus; DEVANE score ≥ 4)
15822692|NCT04262700|Device|LifeScan's new BGMS|LifeScan new Blood Glucose Monitoring System (BGMS)
15822693|NCT04262687|Drug|Capecitabine|2000 mg/m²/day, from day 1 to 14 of each cycle
15822694|NCT04262687|Drug|Oxaliplatin|130 mg/m² by IV infusion over 2 hours, on day 1 of each cycle
15822695|NCT04262687|Drug|Bevacizumab|7.5 mg/kg by IV infusion over 60 minutes, on day 1 of each cycle
15822696|NCT04262687|Drug|Pembrolizumab|200 mg by IV infusion over 30 minutes, on day 1 of each cycle
15822697|NCT04262674|Other|Cognitive-motor training|Simultaneous cognitive-motor training and strength training
15822698|NCT04262661|Drug|NNC0472-0147|Part 1: A single dose of NNC0472-0147, dose increased in each cohort. Part 2: Daily doses of NNC0472-0147, dose increased in each cohort.
15822699|NCT04262661|Drug|insulin glargine|Part 2: A fixed dose level of 0.5 U/kg insulin glargine will be used in all cohorts.
15822700|NCT04262661|Drug|Placebo (NNC0472-0147)|Part 1: A single dose of placebo, dose increased in each cohort.
15822701|NCT04262648|Dietary Supplement|Lactobacillus Reuteri|Lactobacillus Reuteri NCIMB 30351
15822702|NCT04262648|Dietary Supplement|Placebo|Sunflower oil
15822703|NCT04262635|Drug|Cetuximab, Capecitabine|Maintenance treatment ( ArmA )
15822704|NCT04262635|Drug|Cetuximab|Maintenance treatment ( ArmB )
15822705|NCT04262622|Device|Group TEA: thoracic epidural analgesia group|in this group TEA will be performed by the insertion of transthoracic epidural catheter before induction of general anesthesia. Analgesia will be started on wound closure by injecting local anesthetic mixture into the epidural catheter
15822706|NCT04262622|Device|Group RSB: rectus sheath block group|Two sets of epidural catheters which have multiple perforations at the end of the tubing will be surgically applied bilaterally into the rectus sheaths for each patient in this group on wound closure. By the end of surgery,injection of local anesthetic mixture will be started.
15822707|NCT04262609|Radiation|hypofractionated radiotherapy|volumetric modulated moderately fractionated arc therapy
15822708|NCT04262596|Other|A chatbot for patient decision aid|Potential participants use the chatbot on a mobile application with information about cataract surgery choice, and outcome data will be gathered using standardized questions in a structured interview after 2 weeks.
15822709|NCT04262596|Other|A traditional patient decision aid booklet|Potential participants receive a traditional patient decision aid booklet with information about cataract surgery choice, and outcome data will be gathered using standardized questions in a structured interview after 2 weeks.
15822710|NCT04262570|Device|Multispectral Optoacoustic Tomography (MSOT) and Magnetic Resonance Imaging (MRI)|Non-invasive transcutaneous imaging of molecular muscle components
15822711|NCT04262557|Diagnostic Test|Sunrise® solution|Type II medical device with the CE label. It is a chin sensor associated to an integrated and connected platform.
15822712|NCT04262557|Diagnostic Test|Polysomnography|Gold standard method to diagnose SAS used as comparator
15822713|NCT04262544|Behavioral|iCardia4HF|Participants in the intervention group will receive the following main components in addition to usual care: 1) the Heart Failure Health Storylines mobile app which supports daily self-monitoring and management of vital signs and symptoms; 2) three connected health devices (Fitbit activity tracker, Withings Cardio Body weight scale and blood pressure monitor), and 3) a program of tailored text-messages targeting health beliefs, self-efficacy, and HF-knowledge.
15822714|NCT04262544|Other|Usual Care|Participants assigned to the control group will receive usual care and the same connected health devices (Fitbit activity tracker, Withings weight scale and blood pressure monitor) as patients in the intervention group, but without the heart failure health storylines mobile app and text-messaging program. Usual care includes patient education before hospital discharge, and follow-up visits at the outpatient HF clinic a week after discharge and monthly thereafter depending on the patient's condition. Patient education includes literacy-sensitive, education material about HF self-care developed by the Sheps Center for Health Services Research,and a 40-minute education session with an APN and a dietician to review and discuss the education material provided to the patient.
15822715|NCT04262518|Device|Outcomes4Me Mobile App|A mobile app that provides patient navigation and treatment and clinical trial options to people with breast cancer
15822716|NCT04262505|Behavioral|Mediterranean Diet Group|Participants will be advised to follow a traditional Mediterranean diet
15822717|NCT04262505|Behavioral|Healthy Eating Group|Participants will be advised to follow the Healthy Eating Guidelines in Ireland
15822718|NCT04262492|Drug|Rivaroxaban|Rivaroxaban 10 mg or 15 mg or 20 mg OD Dabigatran 110 mg or 150 mg BID Apixaban 2.5 mg or 5 mg or 10 mg BID
15822721|NCT04262466|Drug|IMC-F106C|Weekly IV Infusions
15822722|NCT04262466|Drug|anti-PD(L)1|Every 3 weeks
15822723|NCT04262427|Drug|Cyclophosphamide 50mg|cytotoxic chemotherapy
15822724|NCT04262427|Drug|Pembrolizumab 25 mg/1 ML Intravenous Solution [KEYTRUDA]|potent humanized immunoglobulin (Ig) G4 monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD-1) receptor
15822725|NCT04262414|Device|Functional Electrical Stimulation|"The device used was a prototype closed-loop FES system to improve standing balance by activating the ankle plantar flexors and dorsiflexors (i.e. A-FES system). As a closed-loop system, the body's position and velocity are continually monitored, and the level of stimulation adjusted accordingly on a moment-to-moment basis. This differs from currently available FES units, which do not monitor body movement and therefore, provide a constant level of stimulation unless manually adjusted by the user/PT. The control strategy used in the A-FES system mimics the physiological control system in able-bodied people, meaning it has the potential to re-educate normal movement patterns."
15822726|NCT04262401|Behavioral|Standard health coaching|12 weekly sessions of standard health coaching followed by 4 monthly sessions
15822727|NCT04262401|Behavioral|Habit-focused health coaching|12 weekly sessions of standard health coaching followed by 4 monthly sessions
15822728|NCT04262388|Biological|Durvalumab|Durvalumab is a human immunoglobulin G (IgG)1 kappa monoclonal antibody directed against human PD-L1. Durvalumab selectively binds human PD-L1 with high affinity and blocks its ability to bind to PD-1 and cluster of differentiation (CD)80. The fragment crystallizable (Fc) domain of durvalumab contains a triple mutation in the constant domain of the IgG1 heavy chain that reduces binding to the complement component C1q and the Fc gamma receptors responsible for mediating antibody dependent cell mediated cytotoxicity.
15822729|NCT04262388|Biological|Oleclumab|Oleclumab is a human immunoglobulin G1 lambda monoclonal antibody (mAb) with a triple mutation in the heavy chain constant region for reduced effector function. Oleclumab selectively binds to cluster of differentiation 73 (ecto-5'-nucleotidase) (CD73) and inhibits CD73-associated ectonucleotidase activity, thereby inhibiting the CD73-mediated production of immunosuppressive adenosine. Extracellular adenosine contributes to the immunosuppressive effects of both regulatory T cells and myeloid derived suppressor cells, among others. This, in turn, leads to increased antitumor immunity.
15822730|NCT04262375|Biological|Durvalumab|Durvalumab is a human immunoglobulin G (IgG)1 kappa monoclonal antibody directed against human PD-L1. Durvalumab selectively binds human PD-L1 with high affinity and blocks its ability to bind to PD-1 and cluster of differentiation (CD)80. The fragment crystallizable (Fc) domain of durvalumab contains a triple mutation in the constant domain of the IgG1 heavy chain that reduces binding to the complement component C1q and the Fc gamma receptors responsible for mediating antibody dependent cell mediated cytotoxicity.
15822731|NCT04262375|Biological|Oleclumab|Oleclumab is a human immunoglobulin G1 lambda monoclonal antibody (mAb) with a triple mutation in the heavy chain constant region for reduced effector function. Oleclumab selectively binds to cluster of differentiation 73 (ecto-5'-nucleotidase) (CD73) and inhibits CD73-associated ectonucleotidase activity, thereby inhibiting the CD73-mediated production of immunosuppressive adenosine. Extracellular adenosine contributes to the immunosuppressive effects of both regulatory T cells and myeloid derived suppressor cells, among others. This, in turn, leads to increased antitumor immunity.
15822732|NCT04262362|Procedure|Root canal treatment|Incidence of pain that may occur due to sodium hypochlorite extrusion
15822733|NCT04262349|Behavioral|sleep education|As a training program to increase sleep, pregnant women will be given 2 training sessions per week for two weeks and four sessions in total for 60 minutes.
15822734|NCT04262336|Drug|DB-020|Injectable sterile viscous solution of DB-020 and sodium hyaluronate in sterile water
15822736|NCT04262323|Device|novel mobile phone application for blood pressure monitoring.|Comparative blood pressure measurement with the mobile phone application and the non-invasive reference method (upper arm cuff).
15822737|NCT04262310|Other|Small Bowel and Colonic Permeability Test|small bowel and colonic permeability based on oral probe molecules and urine excretion in 60 healthy white, female and male adults aged 18-70y
15822738|NCT04262258|Dietary Supplement|Blueberry enriched diet|The blueberry intervention will consist of participants ingesting two servings of 19 g freeze dried blueberry powder (equivalent to 250 g whole blueberries) daily for six weeks. Subjects will ingest the freeze dried blueberries orally. Freeze dried blueberry powder will be mixed with 8-10 ounces of water and consumed. Subjects will be asked to rinse the cup to wash any remaining blueberries off of the cup and consume the rinse water. Subjects will be given a two week supply at baseline (week 0) and a four week supply when they return for their blood draw at week 2. Subjects will be asked to return empty packets and check-off daily records as a measure of compliance.
15822739|NCT04262245|Procedure|Traditional Irrigation|irrigation with syringe
15822740|NCT04262245|Device|Xp-endo Finisher (XPF)|irrigation activation file
15822741|NCT04262245|Device|Passive Ultrasonic Irrigation|irrigation activation method
15822742|NCT04262245|Device|EndoActivator|irrigation activation method
15822743|NCT04262232|Behavioral|Adapted Ca-HELP for Geriatric Cancer Patients|Intervention group: This intervention will be informed by social-cognitive theory10-13 and modeled after the tailored education and coaching intervention (TEC) used for Ca-HELP previously11 and consists of six components: (1) Assessment of current knowledge, attitudes, and preferences; (2) clarification and correction of misconceptions about cancer pain control; (3) teaching of relevant concepts (education about cancer pain control); (4) planning (identifying goals of care, creating achievable goals of care, and creating strategies to communicate goals of care to providers and family members); (5) rehearsal of communication strategies using role play exercises; and (6) portrayal of learned skills (patient applies skills in visit with healthcare provider).
15822744|NCT04262219|Behavioral|iShare|The iShare intervention consists of a two-episode educational podcast series containing information about breast cancer patients' sexual problems, approaches for addressing sexual concerns, and information about discussing sexual concerns with patients, such as initiating a conversation about sexual health and asking questions to assess sexual concern. Both episodes feature expert guests and relevant discussions or case studies.
15822745|NCT04262206|Drug|Atorvastatin 40 Mg Oral Tablet|To generate knowledge about the role of statins in older adults in whom risk/benefit for primary prevention is understudied,
15822746|NCT04262206|Drug|Placebo oral tablet|To generate knowledge about the role of statins in older adults in whom risk/benefit for primary prevention is understudied,
15822747|NCT04262193|Drug|Suvorexant|In each group, the participant will take 1 tablet (placebo, 10mg or 20mg) 30 minutes before bedtime.
15822748|NCT04262193|Drug|Suvorexant Placebo|Suvorexant Placebo
15822749|NCT04262180|Other|Base intervention-Fitbit with EHR integration|Every subject will start with a base intervention - Fitbit activity tracker with EHR integration including messages delivered via the EHR's patient portal
15822750|NCT04262180|Other|Coaching Calls|Non-responders to base intervention will be randomized to coaching calls.
15822751|NCT04262180|Other|Online Gym|Non-responders to base intervention will be randomized to online gym.
15822752|NCT04262167|Biological|Lung Spheroid Stem Cells 100 million|LSCs grown from autologous trans-bronchial biopsy specimens
15822753|NCT04262167|Biological|Lung Spheroid Stem Cells 200 million|LSCs grown from autologous trans-bronchial biopsy specimens
15822754|NCT04262154|Drug|Atezolizumab|Atezolizumab 1200 mg IV over 60 minutes every 3 weeks
15822755|NCT04262154|Drug|Abiraterone|Abiraterone 1000 mg daily
15822756|NCT04262154|Drug|Prednisone|Prednisone 5 mg daily
15822757|NCT04262154|Drug|Lupron|Lupron 22.5 mg IM injection every 3 months
15822758|NCT04262154|Radiation|Stereotactic Body Radiotherapy (SBRT)|Intensity-modulated, image-guided, ultra-hypofractionated external beam radiotherapy (7.25-7.5 Gy x 5 to prostate and seminal vesicles QOD) will begin around 12 weeks (at Cycle 5 Day 1 (+/-5 days)
15822759|NCT04262141|Drug|IMG-7289|Daily oral dose of 0.6 mg/kg/day IMG-7829 capsules. Dose escalation an de-escalation rules applied as necessary.
15822760|NCT04262115|Behavioral|AM-EX|AM will be instructed to perform 2000 kcal/wk of moderate to vigorous intensity aerobic exercise between the hours of 6 and 10 AM.
15822761|NCT04262115|Behavioral|PM-EX|PM will be instructed to perform 2000 kcal/wk of moderate to vigorous intensity aerobic exercise between the hours of 3 and 7 PM.
15822762|NCT04262102|Behavioral|SD_SF|Women will follow a personalized standard diet, described in National Diet Surveys. And their children will be spoon-fed during complementary feeding.
15822763|NCT04262102|Behavioral|SD_BLW|Women will follow a personalized standard diet, described in National Diet Surveys. And their children will follow a baby-led weaning approach for complementary feeding.
15822764|NCT04262102|Behavioral|HFV_SF|Women will follow personalized diet, high in fruits and vegetables. And their children will be spoon-fed during complementary feeding.
15822765|NCT04262102|Behavioral|HFV_BLW|Women will follow personalized diet, high in fruits and vegetables. And their children will follow a baby-led weaning approach for complementary feeding.
15822766|NCT04262089|Drug|Pembrolizumab (Keytruda)|Pembrolizumab (Keytruda), 200mg IV Q3W for a total of 2 administrations per patient, integrated into standard-of-care protocol prior to surgery. Based on the well-established time lines, the interval between diagnosis and standard of care hysterectomy is sufficient to treat patients with two cycles of pembrolizumab without interfering with standard of care.
15822767|NCT04262076|Other|Pulpine with Polyamidoamine Dendrimer|Removal of infected dentin in class I Cavities followed by application of Polyamidoamine Denrimer on caries affected Dentin that is washed out of the cavity after 30 secs then finally place Pulpine .
15822768|NCT04262063|Behavioral|Tell play do technique|it apply the concept of learning by doing .children will enjoy playing with customized dental models
15822769|NCT04262063|Behavioral|tell show do|Tell: your dentist explaining to you what they'd like to do Show: showing you what is involved (e. g. showing the equipment and demonstrating it on a finger) Do: performing the procedure
15822770|NCT04262050|Device|transcranial direct current stimulation (tDCS) and transcranial magnetic stimulation (TMS)|
15822771|NCT04262037|Diagnostic Test|lung ultrasound|Lung ultrasound will be performed after induction of anesthesia and at the end of the operation with a 5-MHz curved array probe (MindrayDC-N6; Mindray; Shenzhen, China
15822772|NCT04262024|Drug|Cabergoline 0.5Mg orally daily for 1 month plus health education by a nurse|Women with hyperprolactiemia scheduled for cabergoline therapy 0.5 mg daily for one month will be offered health education by a nurse to help minimize prolactin level(group A)
15822773|NCT04262024|Drug|Cabergoline 0.5Mg orally daily for 1 month without health education by a nurse|Women with hyperprolactiemia scheduled for cabergoline therapy 0.5 mg daily for one month will not offered health education by a nurse (group B)
15822774|NCT04262011|Procedure|immediate treatment|Patients allocated to the immediate treatment group will receive full mouth treatment, and will use 0.12% chlorhexidine mouthwash, every 12 hours for a week, and will receive oral hygiene instructions throughout the follow-up period. Patients will be evaluated at the beginning, at 3 and 6 months.
15822775|NCT04262011|Procedure|postponed treatment|Patients allocated to the late treatment group will be assessed at baseline, 3 and 6 months. After the end of the follow-up period, they will receive non-surgical periodontal treatment performed in four sessions.
15822776|NCT04261998|Other|Service-learning program|Intervention group will perform a service-learning program with real patients with heart transplantation, and will have to perform a physical therapy program adapted to a real patient. Two meetings will be performed in order to establish groups, explain the project and search information based on evidence in scientific databases. In addition, three meetings with patients will be stated in order to establish the adapted program based on the real patient's needs and characteristics.
15822777|NCT04261985|Behavioral|healthy weight behaviors supported by web-based mobile phone application|Chorus is a mobile phone platform that provides texting, a web application, and an online community for mHealth interventions.Content is created using existing templates to insert text, images, pictures, audio, video clips, or any combination of these. Users interface with Chorus by clicking a hyperlink embedded in a text message sent to their phone to then access web-based interactions via prompts and clicks. Content is available in English and Spanish.
15822778|NCT04261972|Genetic|Next generation sequencing (NGS)|NGS
15822779|NCT04261959|Other|myoActivation|myoActivation is a novel, structured assessment and non-pharmacological therapeutic approach to both diagnosis and treatment of chronic myofascial pain. A detailed history of the timeline of lifetime trauma combined with a quick, structured and reproducible set of posture and movement tests help to easily identify myofascial components of chronic pain. The therapeutic component is delivered utilizing a needling technique, or myofascial release, focused to active myofascial trigger points, fascia in tension and tethered scars.
15822780|NCT04261959|Other|Physiotherapy|Physiotherapy aims to reduce a patient's pain experience and increase their physical function through physical examination, diagnosis, prognosis, physical intervention, rehabilitation and education (including pain neurophysiology education).
15822781|NCT04261946|Other|Quality of life survey|Unilateral patulous eustachian tube surgically treated were interviewed about our life's quality by a survey
15822782|NCT04261933|Drug|semaglutide|Patients will be treated with commercially available semaglutide in a prefilled pen injector (FlexTouch® variant) according to routine local clinical practice at the discretion of the treating physician. Other anti-hyperglycaemic treatments will be prescribed at the physician's discretion.
15822783|NCT04261920|Drug|Huangqi Guizhi Wuwu decoction|"The experimental group took Huangqi Guizhi Wuwu decoction twice a day, infused with warm water. Consistently used during patients receiving XELOX5 adjuvant chemotherapy for at least 12 weeks (every 3 week is a cycle, 4 cycles).
~The control group took placebo twice a day, infused with warm water. Consistently used during patients receiving XELOX5 adjuvant chemotherapy for at least 12 weeks (every 3 week is a cycle, 4 cycles)."
15822784|NCT04261907|Drug|ASC09/ritonavir group|ASC09/ritonavir(300mg/100mg tablet), one tablet each time, twice daily, for 14 days, +conventional standardized treatment
15822785|NCT04261907|Drug|lopinavir/ritonavir group|Lopinavir/ritonavir tablets(200mg / 50mg tablet), two tablets each time, twice daily, for 14 days, +conventional standardized treatment
15822786|NCT04261894|Behavioral|OPTIMIZE|The study intervention is implementation of the OPTIMIZE perinatal care checklist with patient navigation support. The checklist will contain perinatal care components to be assessed for each participant. Specifically, the checklist will be built into the electronic health record as a secure digital record of: (1) the participant's adherence to the recommended prenatal and postpartum visit schedule, (2) the completion of procedures and processes in a participant's prenatal and postpartum standard care plan, and (3) the completion of processes to address social determinants of health, along with completion of referrals to appropriate support resources. The OPTIMIZE checklist will also include records of patient navigation review, engagement, and tracking of barrier status and resolution
15822787|NCT04261881|Dietary Supplement|ATP-Fuel|5 capsules daily with breakfast and 5 capsules daily with lunch
15822788|NCT04261881|Dietary Supplement|ATP-II|3 capsules daily with breakfast
15822789|NCT04261881|Dietary Supplement|ATP-II|3 capsules daily with breakfast and 3 capsules daily with lunch
15822790|NCT04261868|Device|Virtual Reality|New treatment for amblyopia therapy using playing games
15822791|NCT04261868|Other|Patching|Patching
15822792|NCT04261855|Drug|Avelumab|All patients will receive avelumab intravenously (IV) at 10 mg/kg every 2 weeks for 24 months or until unacceptable toxicity or evidence of disease progression
15822793|NCT04261855|Radiation|External Beam Radiation Therapy (EBRT)|Patients registered to Arm A or randomised to Arm B will receive EBRT on 2 occasions, 8-10 weeks apart
15822794|NCT04261855|Radiation|Lutetium-177 (177Lu)-DOTATATE|Patients randomised to Arm C will receive 177-Lu-DOTATATE treatment on 2 occasions, 8-10 weeks apart
15822795|NCT04261829|Procedure|Autologous Fat Transfer|Female breast cancer patients who were surgically treated with mastectomy could opt for a full breast reconstruction with Autologous Fat Transfer in combination with external expansion.
15822796|NCT04261816|Procedure|extubation in the operating room|Patients who underwent liver transplantation early extubation in the operating room immediately following liver transplantation
15822797|NCT04261816|Procedure|extubation in the ICU|Patients who underwent liver transplantation extubation in the ICU following liver transplantation
15822798|NCT04261803|Biological|salivary sample|spit of saliva in a tube
15822799|NCT04261803|Biological|blood test|2millilitter blood test
15822800|NCT04261790|Drug|Ocrelizumab|Patients will be treated with two courses of ocrelizumab (Ocrevus) 600mg/course, for one year and then will stop the medication and will be monitored for the return of the disease activity. Those who experience the return of the disease activity can go back on the medication.
15822801|NCT04261777|Drug|Ferrotran® (Ferumoxtran-10)|"Ferrotran® in a dose of 0.13 mL/kg body weight of the reconstituted freeze-dried preparation (i.e. 2.6 mgFe/kg body weight). The recommended dose should be diluted in 100 mL of NaCl 9 mg/mL (0.9%) solution for injection/infusion prior to administration via the infusion filter as a slow intravenous infusion over 30 minutes (at a maximum rate of 4 mL/min).
~Ferrotran® will be administered once to each patient. Histologically confirmed diagnosis and pre-operative staging are performed prior to the study as part of standard care. Surgery (RP with ePLND) and sampling of tissue specimens is performed after the Ferrotran®-enhanced MRI as part of standard care."
15822802|NCT04261764|Device|"Fastening-mimicking diet combined with a dispelling dampness meal replacement"|"Apply fastening-mimicking diet combined with a dispelling dampness meal replacement. For the convenience of implementation, a cycle of 4 weeks. The first 5 days of each cycle is the calorie restriction stage (daily calorie about 800kcal). The traditional Chinese medicine with dampness effect is used as the main source of calories in this stage. The normal diet is carried out under the guidance of a professional dietitian for the next 23 days. Study for 12 weeks."
15822803|NCT04261764|Other|Normal diet|Carrying out normal diet under the guidance of a dietitian.
15822804|NCT04261751|Other|Clinician Questionnaire|Physicians, Nurses and Respiratory Therapists will take the Clinician Questionnaire electronically
15822805|NCT04261738|Device|Hyperbaric Oxygen|Volunteers will be given a standard hyperbaric oxygen treatment (2.4 ATA x 90 minutes)
15822806|NCT04261725|Genetic|EGFR mutation|Searching the EGFR mutation in pulmonary biopsy
15822807|NCT04261712|Drug|Paltusotine|Paltusotine, capsules, once daily by mouth
15822808|NCT04261686|Device|Covera Vascular Covered Stent|This is a single-arm study. All subjects will receive the Covera Vascular Covered Stent
15822809|NCT04261673|Procedure|Decompressive Craniectomy|A large bone flap must be raised. The evacuation of epidural hematoma is depended on surgeon's preference. The bone flap should not be replaced at the end of the operation. DC has an advantage in controlling brain swelling, but patient is necessary to have another operation of cranioplasty to reconstruct the skull in the future.
15822810|NCT04261673|Procedure|Craniotomy|A large bone flap must be raised. The evacuation of epidural hematoma is depended on surgeon's preference. However, the bone flap must be replaced and fixed with fixation system (plates and screws). The patient will not need an additional operation to rebuild the skull in the future. But undisciplinable brain swelling and increased intracranial pressure may happen in some patients, and additional decompressive craniectomy is recommended in these cases.
15822811|NCT04261660|Other|NO intervention|NO INTERVENTION
15822812|NCT04261647|Other|kinesio-taping techniques.|
15822813|NCT04261647|Other|Pelvic floor exercise|
15822814|NCT04261647|Other|traditional physical therapy program , stretching of piriformis. iliopsoas, clam shell exercise,seat cushioning and seat kitz.|
15822815|NCT04261634|Procedure|Concentrated Growth Factor Membrane|Concentrated growth factor is produced by the centrifugation of venous blood and platelets are concentrated in a gel layer containing fibrin matrix
15822816|NCT04261634|Procedure|Platelet Rich Fibrin|Platelet Rich Fibrinis produced by the centrifugation of venous blood and platelets are concentrated in a gel layer containing fibrin matrix
15822817|NCT04261595|Other|Dates fruit as functional Food|Two groups will receive Dates; The number per group is dependant on the child age. For children aged 3-6 years; they will receive the minimum numbers of dates (3 pieces). For children aged more than 6-12 years will receive 5 pieces of Dates the choice of the minimum numbers of dates (3 pieces) in this current trial is based on a study that was done by Al Jaouni and his colleagues, 2019 which proved the effects of three pieces of Ajwa on infection, hospitalization, and survival among 26 pediatric cancer patients in a university hospital; for which their treatment outcome was improved due to their intake of this amount of Ajwa during their standard treatment
15822818|NCT04261595|Behavioral|behavioral modification and stimulation|Behavioral modification applied to the autistic children that is based on applied behavior analysis (ABA), a widely accepted approach that tracks a child's progress in improving his or her skills. We use Positive Behavioral and Support (PBS)
15822819|NCT04261595|Other|nutritional Guidance|The nutritional education sessions are based on educating parents on providing their autistic children with a nutritious, balanced diet. Because children with ASD often have restricted diets as well as difficulty sitting through meal times, they may not be getting all the nutrients they need, particularly calcium and protein
15822820|NCT04261569|Device|Ev-NIRT|Endoventricular near infra red treatment : Intraventricular pulsed, chronic, cyclic, near-infrared illumination of the Central Nervous System (CNS) at 150 Hz, 15 mW, 1 minute ON and 5 minutes OFF
15822821|NCT04261556|Device|Real HD-tDCS + CCT|"40 min/day of computerised cognitive training (CCT) + 20 min/day of real anodal high definition transcranial direct current stimulation (HD-tDCS).
~In the first 20 min of the 40 min-intervention, real anodal HD-tDCS and CCT will be provided simultaneously."
15822822|NCT04261556|Device|Sham HD-tDCS + CCT|"40 min/day of computerised cognitive training (CCT) + 20 min/day of apparent (sham) HD-tDCS.
~In the first 20 min of the 40 min-intervention, sham HD-tDCS and CCT will be provided simultaneously."
15822823|NCT04261543|Other|High protein and early exercise|High protein is defined as protein prescription of ≥2.2 gram/kg body weight and early exercise is defined as starting cycle ergometry intervention within 24 hours of randomization
15822824|NCT04261543|Other|Usual Care|Usual care group has protein prescription of ≤1.2 gram/kg body weight and exercise at the discretion of attending clinicians
15822825|NCT04261530|Behavioral|Self-hypnosis/self-care|
15822826|NCT04261530|Behavioral|Music/self-care|
15822827|NCT04261530|Behavioral|Self-care|
15822828|NCT04261530|Behavioral|Psycho-education|
15822829|NCT04261517|Drug|Hydroxychloroquine|Subjects take hydroxychloroquine 400 mg per day for 5 days, also take conventional treatments
15822830|NCT04261504|Behavioral|IBMT|mindful presence in a non-judgmental way
15822831|NCT04261504|Behavioral|RT|progressive muscle relaxation
15822832|NCT04261491|Procedure|scaling and root planing|scaling and root planing
15824017|NCT04252222|Device|Videolaryngoscopy with VL3|Tracheal Intubation aided by VL3 Videolaryngoscope
15822833|NCT04261478|Device|Carotid artery stenting|The type of stent should be one commonly used for ICA stenting. Balloon angioplasty before and/or after stent placement will be allowed as required. Stenting should be performed after intracranial thrombectomy unless specific technical circumstances suggest that access to the intracranial circulation requires anterograde stenting. Embolic protection devices should not be used routinely during ICA stent placement.
15822834|NCT04261478|Drug|Antiplatelet Agents|The following antiplatelet regimen should be used: For patients having received IV thrombolysis, immediate post-procedural oral or intrarectal single antiplatelet agents, (Aspirin 325mg PO or 650mg PR). A second agent (usually Clopidogrel 300mg PO) is added after follow-up brain imaging at 12-24 hours confirms absence of significant ICH. For patients having not been treated with IV thrombolysis, dual antiplatelet therapy (Aspirin 325mg PO or 650mg PR and Clopidogrel 300-600mg PO) is given immediately post-procedure. Routine use of GPIIb/IIIa inhibitors, periprocedural IV Heparin is discouraged.
15822835|NCT04261465|Drug|Olaparib|PARP INHIBITOR
15822836|NCT04261465|Drug|Paclitaxel|Chemotherapy
15822837|NCT04261465|Drug|Carboplatin|Chemotherapy
15822838|NCT04261452|Diagnostic Test|isokinetic dynamometer|"Knee flexors and extensors muscles were analysed by an isokinetic dynamometer. Positioning of the subjects (sitting with hips flexed to 75°) was standardized based on the length of the thigh and leg to minimize individual differences. Correction for the effect of gravity on neuromuscular performance was accomplished by incorporating limb mass into the calculation of torque production. Previous warm-up was repeated five time with an angular velocity of 400°/s. All patients randomly performed two maximal isokinetic tests: 6 repetitions at 60°/s and 20 repetitions at 300°/s.
~Measurements of torque, work (J), power (W) maximum (peak), and fatigue index were obtained in both tests. In addition, data were analysed at percent of prediction (percent pred) by reference values previously described for the Brazilian population, corrected by muscle mass and peak values."
15822839|NCT04261452|Diagnostic Test|Cardiopulmonary Exercise Test|"All exercise tests were performed on an electronically braked cycle ergometer. Standard metabolic and ventilatory responses were measured breath-by-breath using a calibrated, computer-based system.
~The incremental exercise test started with 2-min unloaded cycling and increments of 3-10 Watts per min until exhaustion. The anaerobic threshold was estimated by the ventilatory equivalents and V-slope methods and it was determined in agreement by a cardiologist and pulmonologist. Heart rate was determined using the 12-lead electrocardiogram. Throughout the experiment, the pulse hemoglobin saturation (SpO2) was assessed with a pulse oximeter and the 'shortness of breath' was asked at exercise cessation using the 0-10 Borg category ratio scale. All measurements were expressed as percentage predicted for the Brazilian population."
15822840|NCT04261452|Diagnostic Test|Functional Capacity Tests|"The six-minute walk test (6MWT) was in accordance with the American Thoracic Society (ATS). The four-minute step test (4MST) consisted of going up and down a 20-cm high, 40-cm wide and 40-cm long step for 4 minutes.
~The investigators measured the heart rate and pulse hemoglobin saturation at rest before each test and every minute of both tests. The investigators assessed dyspnoea and leg fatigue at rest and with the modified Borg scale immediately after finishing the test."
15822841|NCT04261452|Diagnostic Test|Lung Function Test|"Spirometry, gas transfer, and static lung volumes were measured in all patients, and airflow was measured using a Pitot-tube based on the American Thoracic Society/European Respiratory Society guidelines. Measurement of maximal inspiratory and expiratory pressures was performed from the residual volume and total lung capacity. Resting blood gases were obtained by samples from the radial artery."
15822842|NCT04261452|Diagnostic Test|Doppler Echocardiography|The same medical doctor performed all echocardiograms and all patients underwent comprehensive echocardiography.
15822843|NCT04261452|Diagnostic Test|Anthropometry and Body Composition|"Body composition was assessed using a body composition analyzer. Percent body fat was estimated from the resistance and reactance values.
~Resistance values and the subject's height (meters), weight (kg), sex, and age (years) were entered into a computer program to estimate percentage of fat, fat mass (FM), and muscle mass (MM)."
15822844|NCT04261439|Drug|NIZ985 and Spartalizumab|NIZ985 injection Spartalizumab infusion
15822845|NCT04261426|Drug|Intravenous Immunoglobulin|IVIG 0.5g/kg/d for 5 days
15822846|NCT04261426|Other|Standard care|Standard care
15822847|NCT04261413|Drug|RS-0139|RS-0139 will be administered for the indication of NSCLC.
15822848|NCT04261400|Behavioral|MAMAACT|Improved communication regarding warning signs of pregnancy complications
15822849|NCT04261387|Drug|LUT014 Gel|Topical application qd for 28 days
15822850|NCT04261387|Drug|Placebo for LUT014 Gel|Matching placebo for qd topical application for 28 days
15822851|NCT04261374|Diagnostic Test|Measurement of sublingual microcirculation|Measurement of sublingual microcirculation
15822852|NCT04261361|Behavioral|CBT-AD intervention|8 group CBT-AD sessions and 4 weekly follow-up calls
15822853|NCT04261361|Behavioral|Adherence counseling|All participants in both CBT-AD and ETAU groups will have one session of Life-Steps, a stand-alone CBT intervention designed to improve adherence to medical recommendations and individualized DM self-management goals.
15822854|NCT04261361|Behavioral|Psycho-education package|Printed materials of a DM self-management education program will be delivered to both the CBT-AD and ETAU groups.
15822855|NCT04261348|Other|No intervention|There is no intervention
15822856|NCT04261335|Biological|CL2020 cells|1.5 million or 15 million cells, IV on day 5 to 14 of birth
15822857|NCT04261322|Radiation|x ray exposure|exposure of whole body to x ray
15822858|NCT04261309|Other|Usual care|Since this is an observational study there will be no interference with the care given by the primary healthcare providers. However, the usual care provided by these and other healthcare utilization used by the patients during follow-up will be recorded during the follow-ups.
15822859|NCT04261296|Other|dry needling|In this treatment, depending on the thickness of the adipose tissue under the skin, 13 mm, 25 mm or 30 mm long; 0.20 mm thick acupuncture needle is used
15822860|NCT04261296|Other|balneotherapy|"This treatment method; An alert-fit performed in a certain time interval and in a cure style by using the methods and doses of hot mineral waters, gases and peloids (sludge) from natural underground, determined in detail, repeatedly in series as bath, drinking and inhalation treatments. treatment can be defined as. There are studies showing that the effect of balneotherapy is mechanical, thermal, chemical, anti-inflammatory and immunological."
15822861|NCT04261296|Other|dry needling +balneotherapy|Both of these methods will be applied to patients in the third group.
15822862|NCT04261283|Other|Experimental|"The Circuit Training will be consisting of:
~Habituation Exercises
~Exercises for the gaze stability (The two exercises are specifically for the patients who reported a high score on oscillopsia severity questionnaire
~Exercises to improve Saccade Latency.
~Adaptation Exercises
~Substitution Exercises
~Postural Control Exercises
~General Conditioning Activities
~Cawthorne-Cooksey Exercises
~Ocular Motor Exercises
~Gait Exercises
~Treatment to Decrease Sensitivity to Motion in the Environment"
15822863|NCT04261283|Other|Active Comparator|Medicines as prescribed by the ear, nose, and throat (ENT) specialist and Home-based exercise Programme (Simple and general vestibular rehabilitation exercises) will be recommended to the patients to perform. ( Not under the supervision of neuro-therapist)
15822864|NCT04261270|Drug|ASC09F+Oseltamivir|ASC09F tablets:one tablet(400mg/tablet)twice a day for 14 days;Oseltamivir tablet:75mg,once a day
15822865|NCT04261270|Drug|Ritonavir+Oseltamivir|Ritonavir tablet:three tablets(100mg/tablet)twice a day for 14 days;Oseltamivir tablet:75mg,once a day
15822866|NCT04261270|Drug|Oseltamivir|75mg ,once a day
15822867|NCT04261257|Other|Cardiac scanner|"As part of the usual care of patients hospitalized for stroke, the following examinations are carried out: a trans-thoracic cardiac ultrasound, a transesophageal cardiac ultrasound according to the needs of patient's care, an echo-doppler of the supraaortic trunks, a CT angiography of the supraaortic trunks, a transcranial doppler, a biological assessment, a 24-hour holter or long-term holter.
~The additional examination, specific to the research, corresponds to a cardiac scanner, which does not require the additional injection of contrast medium, carried out during the cerebral artery scanner within 36 hours of discovering the stroke. Within 3 days after inclusion, a trans-thoracic cardiac ultrasound, and a transesophageal cardiac ultrasound according to the needs of patient's care are carried out."
15822868|NCT04261244|Radiation|preoperative radiotherapy|preoperative radiotherapy instead of postoperative radiotherapy in breast cancer after neoadjuvant chemotherapy
15822869|NCT04261244|Radiation|postoperative radiotherapy|postoperative radiotherapy in breast cancer after neoadjuvant chemotherapy
15822870|NCT04261231|Procedure|Surgery and anesthesia|Elective surgery in adults
15822871|NCT04261218|Drug|tomivosertib|Tomivoserib is supplied as a 100 mg capsule, to be taken orally.
15822872|NCT04261218|Drug|paclitaxel|Taken weekly according to the current market label in combination with experimental tomivosertib.
15822873|NCT04261192|Other|Constitution of tumor and blood samples|Constitution of tumor and blood samples
15822874|NCT04261179|Drug|Lymphoseek|50 μg microgram(s), timepoint: 30-60 minutes
15822875|NCT04261179|Drug|Nanocoll|500 μg microgram(s), timepoint: 30-60 minutes
15822876|NCT04261166|Drug|BOL-PK-ST-02A|drops
15822877|NCT04261166|Drug|BOL-PK-ST-02C|drops
15822878|NCT04261166|Drug|BOL-PK-ST-02B|drops
15822879|NCT04261166|Drug|BOL-PK-ST-02F|Sublingual tablets
15822880|NCT04261166|Drug|BOL-PK-ST-02E|Sublingual tablets
15822881|NCT04261166|Drug|BOL-PK-ST-02D|Sublingual tablets
15822882|NCT04261153|Other|Cognitive stimulation|3 cognitive stimulation sessions in total from the HAPPYNeuron® software, approximately 20 minutes each and spread over several days
15822883|NCT04261140|Other|EQUIA Forte Fil|"Apply cavity conditioner (20% polyacrylic acid) 10 s on enamel and dentine, rinse Mix 10 s and apply bulk-fill Apply EQUIA coat and light cure for 20 s
~unit"
15822884|NCT04261140|Other|Clearfil Majesty Esthetic|Apply in 2-mm increment, light cure for 20 s
15822885|NCT04261140|Other|NexComp Flow|Apply in 2-mm increment light cure for 20 s
15822886|NCT04261140|Other|3M Espe Bulk-fill|Apply in single increment up to 4 mm; light curing for 20 s
15822887|NCT04261127|Genetic|Genetic diagnosis (PMDA panel)|Blood samples for DNA study
15822888|NCT04261127|Diagnostic Test|Use of RADIAL algorithm|RADIAL card filling (contains clinical and biological data)
15822889|NCT04261101|Other|Test-enhanced learning|Test-enhanced learning with short answers of questions regarding diabetes and adrenal
15822890|NCT04261075|Biological|IPH5201|Ascending dose levels of IPH5201 every 3 weeks (Q3W) for a maximum of 2 years
15822891|NCT04261075|Biological|durvalumab|Durvalumab Q3W for a maximum of 2 years
15822892|NCT04261075|Biological|oleclumab|Oleclumab Q3W for a maximum of 2 years
15822893|NCT04261049|Drug|Triamcinolone Acetonide Extended-Release Injectable Suspension|A single ZILRETTA® (triamcinolone acetonide extended-release injectable suspension) intra-articular knee injection.
15822894|NCT04261036|Drug|Ascorbic Acid 1000 mg|1000 mg ascorbic acid (Vitamin C) for 14 days post-op after an elective gynecological surgery.
15822895|NCT04261036|Other|Placebo|Placebo pills for 14 days post-op after an elective gynecological surgery.
15822896|NCT04261023|Drug|Orencia 125 MG Per 1 ML Prefilled Syringe|Abatacept sub-cutaneous injection 125mg at week 0 and once weekly thereafter for a maximum of 48 weeks
15822897|NCT04261010|Procedure|Global/single cell gene expression profiles obtained from Synovial biopsies|Global/single cell gene expression profiles obtained from synovial biopsies before and after 24 weeks of treatment with the drug.
15822898|NCT04260997|Dietary Supplement|Lactobacillus gasseri BNR17™ capsule|Once per day (QD), 12 weeks
15822899|NCT04260997|Other|Placebo capsule|Once per day (QD), 12 weeks
15822900|NCT04260984|Procedure|US-guided injection|For US-guided injection, a 22 MHZ linear array probe (Esaote MyLab™ClassC, Italy) will be used for guidance of injection via a transverse scan, in-plane approach. After sterilization, the probe will be placed at the radial styloid with maximal swelling or tenderness. Then a 2.5 cm 25-gauge needle will be placed into the tendon sheath via transverse scan, in-the-plane approach, and the injectate will be pushed into the tendon sheath. Care will be taken avoiding injury of vessels and the superficial branch of radial nerve during the injection.
15822901|NCT04260984|Procedure|palpation-guided injection|Injectate: a mixture of 10mg triamcinolone acetonide (10mg/1ml) and 0.3ml 1% lidocaine. For palpation-guided injection, a 2.5cm 25-gauge needle will be inserted almost horizontally between APL and EPB tendons, just distal to the radial styloid, at the site of maximum tenderness. Then the mixture of triamcinolone and lidocaine will be pushed into the common tendon sheath.
15822902|NCT04260971|Device|Abbott St Jude Medical Infinity 7 neurostimulator|The stimulator has the capability to deliver both continuous and cyclical modes of stimulation which is being investigated in this study
15824018|NCT04252209|Other|natural herbs of coconut, aloe vera, and pepperint|mixture of herbal oils of coconut, peppermint, aloe vera
15822903|NCT04260958|Other|Exercise-based cardiac rehabilitation|The exercise program (remote/centre-based) will be standardized. An exCR-program is defined as at least 24 supervised sessions, with a total session length of 60 minutes, for at least 3 months, with possibility to complete missed sessions the 4th month. Each exercise session includes at least 20 min of aerobic exercise, intensity 13-17 on Borg´s rating of perceived exertion (RPE)-scale ≈ 60% - 85% of VO2max or 70 - 95% of maximal heart rate. In addition, each exercise session includes 1-3 sets of 8-10 upper and/or lower limb exercises in 10-15 repetitions, 40-80% of 1 repetition maximum. Attending ≥75% of the 24 sessions over a 4-month period will be considered as successful.
15822904|NCT04260945|Biological|CD19/CD20 Dual-CAR-T cells|CD19/CD20 Dual-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for 2 days before infusion.CD19/CD20 Dual-CAR-T cells will be intravenously infused with a escalated dose of 0.6-3×106 cells/kg.
15822905|NCT04260932|Biological|CD19/CD20 Dual-CAR-T cells|CD19/CD20 Dual-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest at least for 2 days before infusion. CD19/CD20 Dual-CAR-T cells will be intravenously infused with a escalated dose of 1-6×106 cells/kg.
15822906|NCT04260919|Procedure|Chest physiotherapy|
15822907|NCT04260906|Device|Vagus nerve stimulator|Vagus nerve stimulation is carried out with a TENS device, which has specially designed surface electrodes in the shape of earphones, the size of which can be selected according to ear size. Electrodes were placed to correspond with the inner and rear surfaces of the tragus and the concha for both ears (Figure 1). The application is carried out, for 30 minutes, using a biphasic, asymmetrical waveform with a pulse duration that is less than 500 microseconds and a frequency of 10 Hertz.
15822908|NCT04260906|Other|exercise|The exercise group was assigned a program, which consisted of strengthening, stretching, isometric and posture exercises, targeting the body and upper and lower extremities. That program was home-based and the program was requested to be completed. Patients were asked to attend weekly face to face sessions with a total of 4 of these sessions in the study duration.
15822909|NCT04260893|Device|Tixel|Peri-Orbital fractional treatment on the Eye-Lid to assess the effect on Dry Eye symptoms
15822910|NCT04260880|Other|periodontal status in mild depression patients|Assessment of periodontal status in mild depression patients
15822911|NCT04260880|Other|periodontal status in moderate depression patients|Assessment of periodontal status in moderate depression patients
15822912|NCT04260880|Other|periodontal status in systemically healthy patients|Assessment of periodontal status in systemically healthy patients
15822913|NCT04260867|Other|Essential Oil|Those randomized to the treatment group will have containers filled with the essential oil of their choice.
15822914|NCT04260867|Other|No Essential Oil|Those randomized to the control group will then be given empty single-use handheld aromatherapy containers containing no essential oil.
15822915|NCT04260854|Drug|Bupivacaine Hydrochloride|Bupivacaine hydrochloride (Hospira, Inc) is an FDA approved, local, injectable indicated for the production of local or regional anesthesia or analgesia for surgery.
15822916|NCT04260854|Drug|Saline|Normal saline injections.
15822917|NCT04260841|Device|bed in 45 degrees for passive leg raising test|fluid responsiveness is tested by the passive leg raising test
15822918|NCT04260828|Drug|Aspirin 100mg|Daily active drug administered orally for 3 months.
15822919|NCT04260828|Other|Placebo|Sugar pill administered orally for 3 months.
15822920|NCT04260815|Device|Transcranial direct-current stimulation (tDCS)|Transcranial direct-current stimulation is a non-invasive brain stimulation method that can modify spontaneous cortical activity in targeted brain regions. Anodal tDCS delivered through a positively charged electrode has been found to increase cortical excitability in a targeted brain region. Application of tDCS has been found to improve language production in healthy and brain-injured speakers.
15822921|NCT04260802|Drug|OC-001|Monotherapy in Phase 1b
15822922|NCT04260802|Drug|OC-001 in Combination|Anti-PD-1/anti-PD-L1 Ab administered per approved prescribing schedule, in Phase 2a
15822923|NCT04260789|Device|Seraph 100,The Microbind Affinity Blood Filter|Treatment with Seraph 100 in one arm
15822924|NCT04260776|Behavioral|Phase 1: Web-based intervention (MyWebQuit) with 1-way text messages|Participants will receive MyWebQuit (web-based smoking intervention) along with a corresponding 1-way text messages
15822925|NCT04260776|Behavioral|Phase 1: Web-based intervention (MyWebQuit) with interactive, 2-way text messages|Participants will receive MyWebQuit (web-based smoking intervention) along with corresponding interactive, 2-way text messages
15822926|NCT04260776|Behavioral|Phase 2: re-engagement text messages|In addition to Phase 1 intervention components, 1/3 of participants who disengage with the website will receive interactive text messages designed to promote re-engagement
15822927|NCT04260776|Behavioral|Phase 2: re-engagement emails|In addition to Phase 1 intervention components, 1/3 of participants who disengage with the website will receive a personalized email designed to promote re-engagement
15822928|NCT04260763|Behavioral|Social Cognition Group|Each session lasts 90 minutes and includes three 20-minute work packages tapping different social cognition skills; specifically affect recognition and theory of mind/mental state attribution in this study. Examples of the work packages include guessing the emotions of others based on their facial expressions, activities such as indicating how confident participants feel about guessing emotions when looking at more ambiguous pictures, and watching/discussing video clips with content relevant to the group.
15822929|NCT04260763|Device|Novel Mobile App|"The novel homework app was designed to deliver tasks to the participants between group therapy sessions. Three types of task were delivered by the app; 'Stories', 'Emotions', and 'Facts and Guesses'. The 'Stories' task was designed to encourage participants to think about how thoughts, emotions and actions interact. Participants were presented with a short vignette and asked to identify the emotion or behaviour of a character. 'Emotions' aimed to target affect perception by presenting faces of different emotion presentations and asking clients to select the correct emotion from a list of three, whilst 'Facts and Guesses' aimed to address difficulties with jumping to conclusions in social situations by showing clients a photograph of a social situation and asking them to determine whether a given statement about the photo was a fact or a guess. Confidence in answers was also assessed in order to encourage flexible thinking."
15822930|NCT04260750|Behavioral|Internet-administered Cognitive behavioral therapy (ICBT)|"The intervention consists of fifteen modules, each having a specific focus on a problem (e.g. comorbid worry alongside the depression) or containing a specific strategy or element (e.g. behavioral activation).
~The fifteen modules are:
~Introduction/Psychoeducation about depression, Behavioral activation 1, Behavioral activation 2, Cognitive restructuring, Acceptance, Psychoeducation about emotions, Anxiety and exposure, Comorbid social anxiety, Comorbid worrying and generalized anxiety, Comorbid panic disorder, Sleep problems, Perfectionism, Stress management, Relaxation, and Relapse prevention.
~The first and last module are assigned to all participants. The rest is picked either by the participants themselves or by the therapist conducting the intake interview."
15822931|NCT04260737|Other|Decision Aid for Men with Localized Prostate Cancer|The intervention is an interactive decision aid aimed to assist newly diagnosed prostate cancer patients with their treatment management options.
15822932|NCT04260724|Device|TMS|"stimulation intensity : motor threshold 100%
~stimulation frequency : 1600 pulses for 20 minutes
~stimulation duration :for four weaks, 20 minutes/day, 5 days per week (Monday - Friday )"
15822933|NCT04260724|Device|sham coil stimulation|no stimulation Although the sound from device during stimulation is similar, no stimulation is applied.
15822934|NCT04260711|Drug|DMT|Discontinuation of patients' own disease modifying therapy (any of the interferons, glatiramer acetate, dimethylfumarate, teriflunomide)
15822935|NCT04260698|Biological|omidubicel|hematopoietic stem cell transplant
15822936|NCT04260685|Drug|Lidocaine|IV bolus of 1.5mg/kg lidocaine 1% followed by continuous infusion of 1.5mg/kg/h
15822937|NCT04260685|Drug|Esmolol|IV bolus of esmolol 0.5 mg/kg followed by continuous infusion of 100-300 ug/kg/min
15822938|NCT04260672|Behavioral|Child Centred Health Dialog (CCHD)|"The universal part of CCHD means a structured dialogue between the nurse and the child in presence of its parents using eight illustrations based on the most important practices associated with overweight in preschool children: fruit and vegetables consumption, intake of sweetened beverages and portion size, physical activity, sedentary behaviour tooth brushing and sleep routines. The health dialog is completed by demonstrating the BMI-growth chart to show BMI development to give parents an accurate weight perception, identify overweight and support parental readiness towards a healthy lifestyle.
~When the child is identified with an overweight or obesity, the entire family is invited to participate in the targeted part of CCHD: the Family Guidance, a family consultation based on the evidence based Standardized Obesity Family Therapy (Nowicka, 2011)."
15822939|NCT04260659|Drug|Dexmedetomidine Hydrochloride [Dexdor]|Initial dosis of dexmedetomidine 1 mcg/kg IBW iv will be administered within 10 minutes before general anesthesia induction. Following intubation infusion of 1 mcg/kg IBW / h will be initiated and continued until the end of operation.
15822940|NCT04260659|Drug|Remifentanil [Ultiva]|Remifentanil TCI Minto Model will be used during induction in dosis 6 ng/ml and intraoperatively appropriately to maintain hemodynamical stability.
15822941|NCT04260659|Drug|Ketamine [Ketalar]|Ketamine 0,5mg/kg IBW iv will be administered during induction of general anesthesia.
15822942|NCT04260659|Drug|Lidocaine [Xylocaine 2%]|Initial dosis of lidocaine 1,5 mg/kg IBW iv will be administered within 10 minutes before general anesthesia induction. Following intubation infusion of 3 mg/kg IBW / h will be initiated and continued until the end of operation.
15822943|NCT04260659|Drug|Magnesium Sulphate [Inj. Magnesii Sulfurici Polpharma]|Magnesium Sulphate will be administered in dosis 50 mg/kg IBW iv intraoperatively.
15822944|NCT04260659|Drug|Fentanyl [Fentanyl WZF]|Rescue dosis of 100 mcg iv will be administered if hypertension > 140/90 mmHg or tachycardia > 120min occurs. If necessary rescue dosis may be repeated.
15822945|NCT04260646|Device|Enuresis Alarm Rodger and Timer watch (Rodger)|Nocturnal enuresis fluid sensitive alarm and Timer watch (Rodger) vibrating or sounding alarm for remembering timed voiding intervals
15822946|NCT04260646|Device|Timer watch (Rodger)|Timer watch (Rodger) vibrating or sounding alarm for remembering timed voiding intervals
15822947|NCT04260633|Device|Dental Monitoring assisted aligner change, 12-hour tray wear time and VPro+ are the interventions for the trial.|"The current standard of care for clear aligner use as suggested by Invisalign is unclear as to how frequently aligners should be changed. We suspect that the frequency for aligner change as determined by the orthodontist using Dental Monitoring will be variable for every participant.
~Vpro+ is an adjunctive therapeutic tool for clear aligner treatment. It is proposed to deliver high frequency vibrations to reduce treatment time and pain associated with clear aligners.
~Align Technology suggests 22-hour wear time for clear aligner therapy. Participants in two arms of the study will be asked to wear the trays for about half the recommended wear time to assess whether night-time aligner wear will be sufficient for successful treatment."
15822948|NCT04260620|Device|Reading of Automated Breast Ultrasound in conjunction with Screening Mammography|Reader performance when SoftVue automated breast ultrasound (SV) and digital screening mammography (DM) are combined, compared to screening mammography alone.
15822949|NCT04260607|Drug|Ketamine Hydrochloride|"Experimental Procedure
~Baseline evaluation of suicidal severity (BSSI) & degree of depressive symptoms (MADRS-S) will be evaluated through self-administered questionnaires.
~The experimental and placebo arms will receive a single dose of IV ketamine, 0.5 mg/kg in 100 cc NS or 100 cc of NS infused over 40 minutes.
~Post ketamine re-evaluation of outcome measures at four and twenty-four hours will determine clinical effectiveness of ketamine intervention
~Inspection of admission and transfer time provides time measurement for LOS. This secondary measure is needed to determine efficiency of intervention.
~Post ketamine re-evaluation of outcome measure at one-week post infusion will elucidate ketamine's durability of effect."
15822950|NCT04260607|Drug|Normal saline|"Experimental Procedure
~Baseline evaluation of suicidal severity (BSSI) & degree of depressive symptoms (MADRS-S) will be evaluated through self-administered questionnaires.
~The placebo arms will receive a single dose of 100 cc of NS infused over 40 minutes.
~Post Placebo infusion re-evaluation of outcome measures at four and twenty-four hours
~Inspection of admission and transfer time provides time measurement for LOS. This secondary measure is needed to determine efficiency of intervention.
~Post Normal Saline re-evaluation of outcome measure at one-week post infusion."
15822951|NCT04260594|Drug|Arbidol|Arbidol tablets: take 2 tablets/time, 3 times/day for 14-20 days
15822952|NCT04260594|Other|basic treatment|basic treatment
15822953|NCT04260581|Drug|Determination of drug effects through amantadine cessation|Patients will discontinue amantadine, which has been taken since beginning of diagnosis.
15822954|NCT04260568|Other|Semi-structured interviews|Patients with a diagnosis of 3PD will be sought from a multidisciplinary balance clinic. Consenting participants will take part in a face-to-face interview about their diagnosis. Data collection will consist of recorded semi-structured interviews, which will be transcribed.
15822955|NCT04260555|Drug|DW1601|Total 7 days of treatment and The daily dose is tid. (DW1601 20ml + Placebo of DW16011 20ml + Placebo of DW16012 9ml)
15822956|NCT04260555|Drug|DW16011|Total 7 days of treatment and The daily dose is tid. (Placebo of DW1601 20ml + DW16011 20ml + Placebo of DW16012 9ml)
15822957|NCT04260555|Drug|DW16012|Total 7 days of treatment and The daily dose is tid. (Placebo of DW1601 20ml + Placebo of DW16011 20ml + DW16012 9ml)
15822958|NCT04260542|Behavioral|Fasting/refeeding|2-days fasting followed by 2-days of refeeding. During the fasting period the subjects will be hospitalized to control their state of health and ensure fasting compliance. During refeeding the standardized meals will be provided to cover individual daily requirements (60% carbohydrates, 15% protein, 25 % fat).
15822959|NCT04260542|Behavioral|Fasting/refeeding|2-days fasting followed by 2-days of refeeding. During the fasting period the subjects will be hospitalized to control their state of health and ensure fasting compliance. During refeeding the standardized meals will be provided to cover individual daily requirements (60% carbohydrates, 15% protein, 25 % fat).
15822960|NCT04260542|Behavioral|Ketogenic diet/ fasting|1 month of fasting-mimicking ketogenic diet and subsequent 2-days of refeeding. The subjects will be instructed by nutritional specialist to follow isocaloric ketogenic diet consisting of 6% carbohydrates, 17 % of proteins and 77% fat to cover individual energy demand. During refeeding the standardized meals will be provided to cover individual daily requirements (60% carbohydrates, 15% protein, 25 % fat).
15822961|NCT04260529|Drug|CyPep-1|Intratumoral injection
15822962|NCT04260529|Drug|Pembrolizumab 25 MG/ML [Keytruda]|IV infusion
15822963|NCT04260516|Drug|N-acetyl cysteine|Mucolytic and antioxidant drug
15822964|NCT04260503|Other|Monitoring of the gut-microbiome and ultrasound elasticity.|The investigator will investigate the alteration of gut-microbiome and liver stiffness by restoration of bile flow by operation.
15822965|NCT04260503|Other|Monitoring of the gut-microbiome|The investigator will investigate the alteration of gut-microbiome before and after operation.
15822966|NCT04260503|Other|Monitoring of the gut-microbiome|The investigator will investigate the alteration of gut-microbiome along with the disease progress.
15822967|NCT04260503|Other|Monitoring of the gut-microbiome.|The investigator will investigate the alteration of gut-microbiome according to the normal development.
15822968|NCT04260477|Drug|6EH³R³Z|"A triple dose is defined as the triple of the routine dose used for a specific WHO weight band. Hence, the mg/kg within a weigh-band varies, as is the case in routine practice.
~Dosing takings into consideration the fixed dose combination (FDC) tablets (one tablet: 150 mg R + 75 mg H + 400 mg Z + 275mg E). Dosage relies on tables with dosage by weight-bands used by WHO for the Cat. 1 regimen. The dosage used for the intensive phase of the Cat. 1 regimen applies for the whole treatment duration. A double dose of H and R is added to the recommended normal dose for adults (WHO,2003)"
15822969|NCT04260477|Drug|6EHRZ|"Recommended normal dose adults (WHO, 2003)
~H: 5 (4-6) mg/kg/day
~R: 10 (8-12) mg/kg/day
~Z: 25 (20-30)mg/kg/day
~E: 15 (15-18)mg/kg/day"
15822970|NCT04260464|Drug|PF-06700841|A single dose of 30 mg PF-06700841 will be administered on Day 1
15822971|NCT04260451|Other|ventilation|"Driving Pressure Limited Ventilation
~Positive end expiratory pressure is adjusted to minimize driving pressure, plateau pressure minus end expiratory pressure from 10 to 2 cmH2O during one-lung ventilation.
~1. Lung recruitment: stepwise increase of positive end expiratory pressure 5,10,15 cmH2O with tidal volume 5mL/kg, inspiratory:expiratory 1:1, respiratory rate 10. and driving pressure up to 20 cmH2O. Then decremental PEEP titration is performed using a volume-controlled ventilation until the lowest driving pressure (plateau pressure minus PEEP) is found. This individualized PEEP is adjusted during one-lung ventilation."
15822972|NCT04260438|Drug|CKD-501 0.5mg Tab. 1T, D759 100mg Tab. 1T and D150 1000mg Tab. 1T|single oral administration under fed condition
15822973|NCT04260438|Drug|CKD-393 0.5/100/1000mg formulation 1 Tab. 1T|single oral administration under fed condition
15822974|NCT04260438|Drug|CKD-393 0.5/100/1000mg formulation 2 Tab. 1T|single oral administration under fed condition
15822975|NCT04260425|Other|Serving of oatmeal made from low avenanthramides oats and water|One serving size (40 grams dry weight) of low avenanthramides oats flakes will be used to make oatmeal. One cup of water and a dash of salt (0.72 g) will be added into the treatment and microwaved on high for 3 minutes. It will be stirred before serving. Ingredients and cooking time will be consistently maintained throughout.
15822976|NCT04260425|Other|Serving of oatmeal made from high avenanthramides oats and water|One serving size (40 grams dry weight) of high avenanthramides oats flakes will be used to make oatmeal. One cup of water and a dash of salt (0.72 g) will be added into the treatment and microwaved on high for 3 minutes. It will be stirred before serving. Ingredients and cooking time will be consistently maintained throughout.
15822977|NCT04260412|Device|medium cut-off (MCO) dialysis membrane|Medium cut-off dialysis (MCO) membrane is a dialysis membrane with a higher molecular weight retention onset and similar cut-off as standard high-flux dialysis membranes. It is capable of providing increased clearance of medium sized uremic toxins and some plasma proteins (cytokines, inflammatory mediators).
15822978|NCT04260412|Dietary Supplement|Dietary fiber mixture (Plantago Psyllium 69% and Inulin 30%)|Dietary fiber (Psyllium 69% and Inulin 30% mixture) added to the meals in the dose of 5g BID for 4 weeks in the second phase of the study.
15822979|NCT04260412|Dietary Supplement|Sodium propionate|Sodium propionate (a short-chain fatty acid) added to the meals in the dose of 500 mg BID in the second phase in the study.
15822980|NCT04260399|Other|Lavender Aromatherapy|Participants in the experimental group will be passively exposed to lavender essential oil
15822981|NCT04260399|Other|Placebo Aromatherapy|Participants in the control group will be passively exposed to saline water aromatherapy
15823074|NCT04259502|Procedure|Rhomboid intercostal block|The block is regional anesthesia injection techniques performed under ultrasound guidance.
15823075|NCT04259502|Procedure|Erector spinae plane block|The block is regional anesthesia injection techniques performed under ultrasound guidance.
15823201|NCT04258488|Drug|Apixaban Oral Tablet|"Apixaban oral tablet 5mg bid
~If age≥80, weight≤60kg, Creatinine≥1.5mg/dl OR moderate or severe renal dysfunction, Apixaban 2.5mg bid"
15822982|NCT04260386|Other|Non-Interventional|"During the cardiac arrest scenario, the delegates observing will be asked to refer to the maternal cardiac arrest proforma and record those details of events that they are able to see/hear from the video link. In addition, the proforma will be provided to the team taking part in the simulation. One or more team members would routinely be given the role of 'scribe', recording events as they occur. The proforma is accompanied by explanatory notes on how to use it.
~Delegates (observers plus scribes) will then be asked to complete a questionnaire, seeking their opinions on the usefulness of the proforma. Questionnaires will be linked to the written consent forms by a participant ID number."
15822983|NCT04260373|Drug|[14C]SHR4640|Patients will receive single dose of orally [14C]SHR4640 on Day 1.
15822984|NCT04260360|Drug|NanoDoce (sterile nanoparticulate docetaxel) Powder for Suspension|NanoDoce is manufactured using a Precipitation with Compressed Antisolvent (PCA) technique that employs supercritical carbon dioxide and acetone to generate docetaxel nanoparticles within a well-characterized particle-size distribution. Prior to administration, the NanoDoce powder in vial is suspended with a sterile solution of Polysorbate 80 (0.0075% - 0.0375% (w/w))/Ethanol (0.06% - 0.3% (w/w)) in 0.9% Sodium Chloride for injection.
15822985|NCT04260347|Drug|Alteplase|Intravenous injection
15822986|NCT04260347|Drug|Alteplase|Intravenous injection
15822987|NCT04260334|Other|Preoperative Education|The first two hours after the hospitalization of the patient will be met and the aim of the study will be explained. On the same day, the patient will be given breathing and relaxation exercises and explained why it is important. On the second day after the hospitalization, the patient will be evaluated and the previous day's exercises will be repeated and leg exercises will be performed. The importance of mobilization will then be highlighted. the same day gradual relaxation exercise and surgical relaxation will be administered to the patient three times. The patient will be evaluated on the first postoperative day.
15822988|NCT04260321|Device|AI|Artificial intelligence colonoscopy
15822989|NCT04260282|Diagnostic Test|Polymerase Chain Reaction (PCR) for viruses and bacteria in nasal swab|PCR for viruses and bacteria in nasal swab
15822990|NCT04260282|Diagnostic Test|Induced sputum microbiome|Microbiome in induced sputum
15822991|NCT04260269|Drug|Fluoropyrimidine|"This is the assessment of a specific evaluation of cardiac safety for patients with solid tumors who have experienced cardiotoxicity grade 1-4 during treatment with a fluoropyrimidine based treatment and are re-challenged with a different fluoropyrimidine.
~This multicentre, retrospective database is built to assess the impact on the cardiac and global safety of two different fluoropyrimidine based treatment regimens, of which the first has caused cardiotoxicity grade 1-4.
~Cardiac data will be collected by medical record review from initiation of first fluoropyrimidine-based treatment and switch to second fluoropyrimidine-based treatment until death or last follow-up. Basic demographics, cancer and treatment information from the whole course of cancer until death or last follow-up."
15822992|NCT04260256|Drug|[18F]F-AraG|[18F]F AraG injection and PET Scan Two tumor biopsies of single lesion
15822993|NCT04260243|Other|Experimental-Myofascial + Respiratory rehabilitation|6 sessions of: Myofascial Release (20 minutes each) + Respiratory rehabilitation (60 minutes each)
15822994|NCT04260243|Other|Sham Myofascial + Respiratory rehabilitation|6 sessions of: Sham Myofascial Release (20 minutes each) + Respiratory rehabilitation (60 minutes each)
15822995|NCT04260230|Device|Lifetemp/Lifetouch sensors|Wearing the devices for six weeks. Data only reviewed retrospectively.
15822996|NCT04260217|Drug|APG2575 400 mg|APG2575 400 mg
15822997|NCT04260217|Drug|APG2575 600 mg|APG2575 600 mg
15822998|NCT04260217|Drug|APG2575 800 mg|APG2575 800 mg
15822999|NCT04260204|Procedure|Pediatric cardiac surgery|
15823001|NCT04260178|Other|An Education-Based Intervention Program and handbook (EBIP, hospital and home)|A handbook was developed in line with the literature and input from two specialist physicians. The handbook consisted of 4 sections that concerned improving breathing exercises, drug compliance, nutrition and illness self-care behavior.
15823002|NCT04260178|Other|PFT, BMI, BDI, SCMP-G|pulmonary function test(PFT), the Baseline Dyspnea Index(BDI), body mass index(BMI) and the Self Care Management Process in Chronic Illness(SCMP-G) scale
15823003|NCT04260165|Procedure|Proximal Row Carpectomy|Excision of the proximal carpal row - the scaphoid, lunate and triquetrum
15823004|NCT04260165|Procedure|Four-corner fusion|Scaphoid excision and four-corner fusion with cannulated headless compression screws/dorsal plate
15823005|NCT04260152|Device|Geistlich Fibro-Gide|Surgical recession root coverage with coronally advanced flap in combination with Geistlich Fibro-Gide
15823006|NCT04260152|Procedure|Connective Tissue Graft (CTG|Surgical recession root coverage with coronally advanced flap in combination with CTG
15823007|NCT04260139|Procedure|Calculation of metric variables on the colectomy specimens.|"Calculation of metric variables on the colectomy specimens including Lengths as mm
~Proximal colon,
~Ileum in cases with right hemicolectomy only,
~Proximal border,
~Tumor,
~Distal border,
~Total specimen,
~Vascular pedicle, the longitudinal distance between the nearest bowel wall and the end of ligated major vascular pedicle depending on the tumor's localization, 2. Colonic mesenteric area as mm2."
15823009|NCT04260113|Drug|Apatinib Mesylate|Apatinib orally 500mg once daily half an hour after meal
15823010|NCT04260100|Behavioral|Diabetes Care Self-Management Mobile Health Application|In day 1, the participant will receive a Foot Care Kit consist of a mirror, a tube of lotion, a small towel, and a nail clipper. The participant will enrol in 3-hour workshop for general management of diabetes mellitus, diabetic foot care and dietary management. The participant will be invited to install Diabetes Care Self-Management Mobile Health Application. The mobile application is meant for sources of referral for diabetic foot care and dietary care, and for record purpose (diary) of any foot care activities carried out that participant needs to enter in the application during his/her home. The participant will be trained for the use of Diabetes Care Mobile Health Application. In addition, the participant will be invited to join a WhatsApp group for the medium of communication. The program will be lasting for 5 weeks.
15823202|NCT04258488|Drug|Vitamin K antagonist(warfarin)|Keep the international normalized ratio (INR) 2.0-3.0
15823011|NCT04260061|Device|training systems|Participants will receive 18 intervention sessions for about 6-9 consecutive weeks in a clinical setting (75 minutes per session, 2-3 sessions per week). For each intervention session, participants will first receive 10 minutes of warm-up followed by 50 minutes robotic-assisted training (robotic-assisted training includes 10 minutes passive training mode, 20 minutes active training mode, and 20 minutes robot-participant interactive training mode) and then 15 minutes of functional activity without robotic-assisted (content will be related to robotic-assisted training and will be based on the action function and preferences of the participants).
15823012|NCT04260035|Drug|Vasoactive Intestinal Polypeptide (VIP)|20 episodic migraine patients without aura of both genders are randomized to receive a 2-hour infusion of VIP and/or sterile saline on two days, with at least one week in between.
15823013|NCT04260035|Drug|Sterile saline|20 episodic migraine patients without aura of both genders are randomized to receive a 2-hour infusion of VIP and/or sterile saline on two days, with at least one week in between.
15823015|NCT04260009|Drug|Brigatinib|Brigatinib tablets
15823016|NCT04260009|Drug|Brigatinib AAF|Brigatinib age-appropriate formulation (AAF)
15823017|NCT04259996|Procedure|PROGESTERONE AND ESTRADIOL SERUM CONCENTRATION MEASUREMENT|The only intervention will be a single determination of serum P and E2 levels immediately before the embryo transfer.
15823018|NCT04259983|Other|Maximal exercise test|The maximal exercise test will be performed on an electronically braked bicycle ergometer.
15823019|NCT04259983|Other|Endothelial dysfunction assessment|Endothelial dysfunction will be determined by blood samples. Blood samples will be collected and analyzed for the responses of ICAM-, VCAM-1, E-Selectin, VEGF, ET-1.
15823020|NCT04259983|Other|Arterial stiffness assessment|Arterial stiffness, oscillometric pulse wave velocity (PWV) and augmentation index will be evaluated by recorded brachial pulse waves with automatically with the oscillometric device.
15823021|NCT04259970|Drug|Initiation of CFTR Modulator|Inhaled contrast for MRI occurring at each 4 visits.
15823022|NCT04259957|Device|Immersive Virtual Reality|Immersive virtual reality games and mindfulness in Oculus Quest Virtual Reality headset
15823023|NCT04259944|Drug|CAPOX|"DAY 1
~OXA 130 mg/m2 administered as intravenous infusion over 2 hours in 250 mL dextrose 5%
~CAPE 1000 mg/m2 administrated per os twice daily
~DAY 2-14
~• CAPE 1000 mg/m2 os twice daily
~Cycle length is 3 weeks comprising 2 hours of oxaliplatin infusion every 21 days, 14 days of oral capecitabine and 7 days of resting."
15823024|NCT04259944|Drug|Capecitabine|"DAY 1-14
~• CAPE 1250 mg/m2 os twice daily
~Cycle length is 3 weeks comprising 14 days of oral capecitabine and 7 days of resting."
15823025|NCT04259944|Drug|FOLFIRI|"Day 1:
~IRI, 180 mg/m2 administered as iv infusion over 30-90 minutes in 250 mL dextrose 5%, concurrently (via a Y-connector) with
~LV, 400 mg/m2 administered as an iv infusion over 2 hours, in 250 mL dextrose 5%, followed by
~5-FU, 400 mg/m2 administered as a bolus injection (iv push administered by hand) and then at 2400 mg/m2 administered as a iv infusion over 46 hours.
~Cycle length is 2 weeks comprising approximately 48 hours of infusion and 12 days of rest."
15823026|NCT04259931|Diagnostic Test|microbiome analysis|gut microbiome composition of C. difficile infected patients with relapsing (basal, at the end of first treatment, at the begin of the relapses and at four and twelve weeks after definitive treatment) and non-relapsing ( basal and four and twelve week after treatment) , will be analyzed.
15823027|NCT04259918|Procedure|Alveolar recruitment maneuver|Applying 30 or 60 cmH2O of alveolar recruitment maneuver 5 times every 5 min at the end of bariatric surgery
15823030|NCT04259892|Biological|2019-nCoV PCR|Nasopharyngeal swabs
15823031|NCT04259879|Other|Fasting|Food intake restriction
15823032|NCT04259853|Procedure|PCI|Revascularization on non culprit vessel
15823033|NCT04259840|Other|Observation|Soft tissue implant measurements
15823034|NCT04259827|Other|Neuronation|Online cognitive training app, with exercises created for patients with mild cognitive impairment
15823035|NCT04259827|Other|Aspecific online games|Online gaming without cognitive training
15823036|NCT04259814|Behavioral|Speech-language therapy (SLT)|Age-appropriate play activities with speech-language pathologist (SLP) to elicit speech, using stimulation strategies including but not limited to recasts, expansion, parallel talk, interactive modeling, communication temptations, and phrase completions. Activities will include an age-appropriate story, pretend play (i.e., house with people, playing with a baby doll), an assembly task (i.e., building blocks, making pretend pizza), and a highly motivating, clinician-controlled activity (i.e., blowing bubbles, swing, pushing cars down a ramp).
15823037|NCT04259814|Behavioral|Modified constraint-induced movement therapy (mCIMT)|Participants will wear a removable cast and an occupational therapist will be present during therapy to focus on facilitating play with the affected arm.
15823038|NCT04259801|Drug|NNC0480-0389|Part 1: A single dose of NNC0480-0389, dose increased in each cohort. Part 2: Weekly doses (for 4 weeks) of NNC0480-0389, dose increased in each cohort.
15823039|NCT04259801|Drug|Semaglutide|Part 1: Single dose of semaglutide (0.5 mg). Part 2: Weekly doses of semaglutide alone for 8 weeks (2 x 0.25 mg, 2 x 0.5 mg and 4 x 1 mg) followed by weekly fixed doses of 1 mg semaglutide for 4 weeks.
15823040|NCT04259801|Drug|Placebo (NNC0480-0389)|Placebo for NNC0480-0389. Part 1: A single dose of placebo (NNC0480-0389), dose increased in each cohort. Part 2: Weekly doses (for 4 weeks) of placebo A, dose increased in each cohort.
15823041|NCT04259801|Drug|Placebo (semaglutide)|Part 1: Single dose of placebo (semaglutide) (0.5 mg). Part 2: Weekly doses of placebo (semaglutide) alone for 8 weeks (2 x 0.25 mg, 2 x 0.5 mg and 4 x 1 mg) followed by weekly fixed doses of 1 mg semaglutide for 4 weeks.
15823042|NCT04259788|Other|AHEI diet|Main intervention is the consumption of an AHEI diet for 12 weeks.
15823104|NCT04259203|Behavioral|Erickson hypnosis|Erickson hypnosis sessions performed by an experienced hypnotherapist, according to a pre-established protocol : 5 sessions (1 per week). Between each session : exercise of auto-hypnosis by the patient himself, at home
15823342|NCT04257357|Behavioral|Active control|Please refer to group description
15823043|NCT04259775|Device|Automated Insulin Dose Adjustment|The system originally developed at Boston Children's Hospital, obtains CGM, insulin delivery, and activity data, from the cloud each day at approximately 8:00 PM using an Application Program Interface (API) calls to commercial companies (primarily Glooko and Tidepool) that aggregate data from different devices used to manage glucose levels in individuals. A detailed statistical and control analysis (see preliminary data study 1 for algorithm details) of the data are then conducted to determine if a change in therapy is required. If the analysis indicates a change in therapy is required, the patient or parent is notified by text or email directing then to a web portal detailing the change. The patient or parent can accept or modify the recommended change. If a change is made, the AIDA system confirms that the change is correctly implemented into the patient's pump or Bluetooth enabled pen when the patient next uploads the device data to the cloud.
15823044|NCT04259775|Device|Control|Standard Care - change in therapy settings effected at regularly scheduled patient visits
15823045|NCT04259762|Behavioral|Breast, Colorectal, and Cervical Cancer Screening Interventions|Adult men and women will receive age- and gender-specific interventions. Women age 50-75 years will receive the interventions for breast, colorectal, and cervical cancers screening. Men age 50-75 years will receive the intervention for colorectal cancer screening. Women age 21-49 years will receive the intervention for cervical cancer screening. The 4-week interventions, delivered once a week, will consist of educational sessions that discuss cancer-specific information (i.e., breast, colorectal, and cervical cancer): breast (colorectal, cervical) cancer myths and facts, risk factors and symptoms, screening, and review/action plan. The educational sessions will be complemented by cancer-specific small media (brochure).
15823046|NCT04259749|Other|Flavor Ban|Only flavored tobacco products are banned
15823047|NCT04259749|Other|Menthol Ban|Mentholated products are banned
15823048|NCT04259749|Other|All flavored and mentholated products available|No bans: All tobacco products are available
15823049|NCT04259723|Other|VR during TAVI|Virtual Reality (VR) glasses
15823050|NCT04259710|Behavioral|Goal-setting intervention|The participant will meet weekly with the investigator, report steps and set goals for the following week.
15823051|NCT04259710|Behavioral|Goal setting with implementation intentions|In addition to the standard goal-setting intervention, the participant will fill out a form that directs them to perform implementation intentions at weeks 1, 5 and 9.
15823052|NCT04259710|Behavioral|Pedometer only|the participant will be given a pedometer and instructed how to use it.
15823053|NCT04259697|Other|Clinical pilates|Clinical pilates exercises will be performed progressively. The duration of each exercise session will be an average of 40 minutes initially and then will be increased to 60 minutes as the program progress.
15823054|NCT04259697|Other|Whole body vibration|Whole body vibration exercises will be performed using the Power Plate pro5 AIRdaptive machine.The duration of each exercise session will be an average of 20 minutes initially and then will be increased to 30 minutes as the program progress.
15823055|NCT04259684|Drug|gases Nitric Oxide (gNO)|Participants in the intervention group will receive gNO blended into the fresh gas flow of the cardiopulmonary bypass (CPB) oxygenator and maintained at 20 ppm via an Ikaria INO Max DSIR (Mallinckrodt Pharmaceuticals, St. Louis, Missouri, USA), with continuous sampling of NO and NO2 concentration from a port adjacent to the oxygenator. The gNO delivery will be initiated when the patient is on CPB and stopped once the patient comes off CPB.
15823056|NCT04259671|Device|My Autism Passport (MAP) Application|Families will be given the application to upload to their mobile device and will be provided information on how to use the App by the research team. MAP is a mobile alternative to the paper version, and offers additional benefits such as the ability to set reminders, see regional developmental service agencies and other resources on a map, and directs the caregiver to information so that they may further their understanding about how to support their child.
15823057|NCT04259658|Combination Product|Calcium electroporation|Patients with cutaneous metastases will be treated with calcium electroporation.
15823058|NCT04259645|Drug|Drug: Bupivacaine 0.375% 20 mL|Each block of 0.375% Bupivacaine x 20 mL
15823059|NCT04259645|Drug|Drug: Bupivacaine 0.375%|Each block of 0.375% Bupivacaine x 20 ml + Normal Saline Solution 20 mL
15823060|NCT04259632|Behavioral|Time Restricted Eating (TRE)|daily eating window restricted to 8 hours
15823061|NCT04259632|Behavioral|Caloric Restriction (CR)|15% daily caloric deficient
15823062|NCT04259619|Device|Low-Level Laser Therapy|The low-level laser emits monochromatic, coherent, bundled laser light. In each therapy a energy dose of 2-4 Joul (J) / centimeter (cm)^2 is applied over a duration of about 30 seconds using level 1 (20 percent of maximum output) of the 350 milliwatt (mW) device.
15823063|NCT04259619|Device|Placebo Therapy|The intervention is conducted identically to the low-level laser therapy but the placebo laser that is used emits only red light that is polychromatic, leading to a reduction in energy being emitted and therewith to no or a smaller effect.
15823064|NCT04259606|Dietary Supplement|Cassia Cinnamon|Reddish - brown to light brown, typical sweet and aromatic free flowing powder.
15823065|NCT04259606|Other|Calcined magnesia|White, odor, color and flavorless thin powder.
15823066|NCT04259593|Other|exercise training|
15823067|NCT04259580|Procedure|Endoscopic retrograde pancreatography (ERCP)|Endoscopic procedure to access biliary and/or pancreatic structures
15823068|NCT04259567|Device|Cytokine absorption|Use of CytoSorb absorber
15823069|NCT04259554|Device|OFC rTMS|repetitive transcranial magnetic stimulation over right orbito-frontal cortex with 1Hz (360 pulses in 6 trains á 60 pulses with 30s intertrain-interval)
15823070|NCT04259541|Diagnostic Test|Psychodiagnostic|Intensity and frequency of specific symptoms, signs of problems in mental health
15823071|NCT04259528|Device|Pediatric endoscopic ultrasound|endoscopic ultrasound at the esophageal stricture site to assess echo texture and esophageal layers
15823072|NCT04259515|Drug|Del Nido|Del Nido cardioplegic solution administered in a single dose at 15-20mg/Kg with a maximum dose of 1L of solution, administered antegrade or retrograde. In those patients in wich the crossclamping time exceed 90 to 120 minutes a manteinance dose of 500ml will be administered.
15823073|NCT04259515|Drug|Buckberg|Buckberg cardioplegical solution administered antegrade and/or retrograde at 1-2ml/Kg for cardiac arrest induction. Arrest manteinance with antegrade and/or retrograde administration at 1-2ml/Kg every 15 to 20 minutes. Reperfusion dose with antegrade or retrograde administration at 15-20 ml/Kg before removing the aortic crossclamp.
15823076|NCT04259489|Behavioral|Shared Care diabetes management|After the inclusion visit, the patients will be randomized to Shared Care group or traditional therapy group. Compared to conventional diabetes education in the traditional therapy group, the Shared Care group provides patients with online services and continuous diabetes management and education through a mobile application. It also addresses that it is important for patients to meet regularly with diabetes multidisciplinary team for better results. The total observation period is 3 years for each patient. The visits will be done every 3 months.
15823077|NCT04259476|Drug|Ketamine Hydrochloride|low dose perioperative ketamine infusion. and its effects on post-operative pain.
15823078|NCT04259463|Procedure|Third molars extraction|Third molars extractions with concious sedation or general anesthesia
15823079|NCT04259450|Drug|AFM24|intravenous infusions
15823080|NCT04259437|Other|High Protein, Energy Dense Nutritional Supplement|Ready to drink oral supplement
15823081|NCT04259424|Device|Aerobic Exercise + Duck Duck Punch|"Subjects will perform 15 minutes of aerobic exercise on a recumbent stationary cycle. On each session the target intensity of aerobic exercise will be 70% heart rate reserve.
~Following a 10-minute rest break subjects will perform 200 repetitions on an upper extremity rehabilitation game called Duck Duck Punch (DDP). Duck Duck Punch is an interactive game with an old school carnival theme. DDP is unique as it uses Microsoft Kinect skeletal tracking technology to assess movement performance. The participant sits in front of the Microsoft Kinect and controls a virtual arm with his/her physical arm; reaching forward to punch virtual ducks. A therapist will oversee the subject's safety and progress during DDP. DDP will be dosed based on the number of repetitions performed. A repetition is recorded when the player moves his/her arm so that the avatar leaves a start position. The goal dose for subjects will be 200 repetitions per DDP session."
15823082|NCT04259411|Device|MitraClip procedure|MitraClip procedure with MitraClip NTR System or MitraClip XTR System
15823083|NCT04259398|Drug|Propofol|propofol 1-2 mg/kg bolus injection for induction of anesthesia propofol continuous infusion for maintenance of anesthesia
15823084|NCT04259398|Drug|Sevoflurane|sevoflurane is administered for induction and maintenance of anesthesia
15823085|NCT04259385|Behavioral|Exposure to sugar-sweetened beverage warning labels|Graphic images of the amount of sugar (randomly assigned teaspoons, packets, or cubes) and text warning labels
15823086|NCT04259385|Behavioral|Exposure to beverage calorie information|Calories for sugar-sweetened and non-sugar-sweetened beverages
15823087|NCT04259359|Drug|Insect Venom|Patients will be treated with bee venom immunotherapy (protocol can be selected by patient). Blood samples are taken before starting VIT to determine specific immunoglobulin E (sIgE) Levels for bee venom components. Patients are sting challenged and the outcome will be recorded.
15823088|NCT04259346|Drug|Ixekizumab|Administered SC.
15823089|NCT04259333|Drug|Celecoxib 200mg|Celecoxib tablet
15823090|NCT04259333|Drug|Acetaminophen, Codeine Drug Combination|acetaminophen-codeine-caffeine tablet
15823093|NCT04259307|Drug|Omapone Peri 724mL or Winuf Peri 654mL|Additional intravenous nutrition of 500 kcal per day for 3 weeks
15823094|NCT04259294|Behavioral|Caspar Telerehabilitation|"The experimental group will receive home-based treatment program through mobile apps while control group will receive through a written home program sheets. The training contents will be equivalent, including trunk and lower limb strengthening and stretching, coordination, balance, and functional exercises that will be related to patients' daily living activities in their home.
~The frequency and duration of the home program will be compromised by both the therapist and the patient. The videos of the home program will be sent to patients' app in smartphone by the therapist in the experimental group. Patients will perform the exercises while watching the videos in the app. After each exercise will be done, patient's performance feedback will be captured by the smartphone and will be sent back to the case therapist each time through the app while those in the control group will record their performance in a log sheet given by the therapists."
15823096|NCT04259268|Other|Quality of preoperative information register|Register of principal (grade ASA classification) and secondary variables (allergies, antiplatelet or blood thinners prescriptions, cardiovascular diseases, present medication)
15823097|NCT04259268|Other|Suitability of information contained in the informed consent|Register of information regarding specific individual risks and personal data (patient and doctor identification and signature)
15823098|NCT04259255|Drug|Edaravone|"Participants will be followed from enrollment up to 24 weeks after treatment initiation (6 treatment cycles - 28 days per cycle, corresponding to a treatment period of approximately 24 weeks) or premature study discontinuation.
~Biomarker testing and clinical assessments will be performed at baseline (at enrollment or before the start of cycle 1), and at cycles 1, 3, and 6. Dosing is 60 mg daily by intravenous infusion for 14 days for the initial treatment cycle, followed by daily dosing on 10 out of 14 days in subsequent treatment cycles."
15823099|NCT04259242|Procedure|SRP|scaling and root planing with ultrasonic scaler and manual instruments
15823100|NCT04259229|Other|Mediterranean Diet -- Mushrooms|During the 2-week baseline period all participants will consume their usual, unrestricted self-chosen diets. During intervention weeks 1-8, all participants will consume the same Mediterranean-style diet, rich in fruits and seafoods and lower in dairy, designed to meet their estimated energy needs. The mushroom group will consume 0.5 cups/day of cooked mushrooms (white button mushrooms and yellow oyster mushrooms on 4 and 3 days/week, respectively). All foods will be provided to subjects during the intervention to achieve the desired eating pattern.
15823101|NCT04259229|Other|Mediterranean Diet -- Control|During the 2-week baseline period all participants will consume their usual, unrestricted self-chosen diets. During intervention weeks 1-8, all participants will consume the same Mediterranean-style diet, rich in fruits and seafoods and lower in dairy, designed to meet their estimated energy needs. The control group will not consume mushrooms at any point. All foods will be provided to subjects during the intervention to achieve the desired eating pattern.
15823102|NCT04259216|Behavioral|IMPACT Intervention|Brief remote session + tailored, daily 8-week mobile application facilitated messaging secondary prevention intervention.
15823103|NCT04259216|Other|Control: Enhanced Online Resources (EOR)|EOR group participants will receive standardized information on cyberbullying.
15823105|NCT04259190|Behavioral|interoceptive exposure|Repeated 60-second trials of voluntary hyperventilation, each followed by a 15-second rest period. Participants will complete a minimum of 8 trials and continue additional trials until ratings of their most feared predicted outcome fall less than or below 5% likelihood.
15823106|NCT04259177|Other|Scale|This test is divided into 3 sections: neurological examination, developmental motor boundary stones and behavioral status, and consists of a total of 37 items. The first part consists of 26 items such as cranial nerve functions, posture, quality, amount of movements, muscle tone, reflex and reactions. The second part evaluates motor development boundary stones consisting of 8 items. The third part refers to the behavioral condition consisting of 3 items. These items can be easily scored. It can be rated as optimal or inadequate. Each item is scored separately (as 0, 1, 2, 3) and the final total score is calculated. The total score ranges from 0-78. The total score shows the global optimal scores.
15823107|NCT04259164|Drug|QVM149|Anti-inflammatory effect of Glycopyrronium added to Mometasone / Indacaterol
15823108|NCT04259164|Drug|QMF149|Mometasone / Indacaterol
15823109|NCT04259151|Device|Electric wheelchair with activated assistance module|This evaluation will be carried out in 3 standardized test circuits of increasing difficulty, one week apart. At each session, the patient will perform the circuit 6 times, including 3 with activated assistance
15823110|NCT04259151|Device|Electric wheelchair with assistance module not activated|This evaluation will be carried out in 3 standardized test circuits of increasing difficulty, one week apart. At each session, the patient will perform the circuit 6 times, including 3 with no activated assistance
15823111|NCT04259138|Biological|Treatment Algorithm A|"Participants who are treatment-naïve at randomization will follow treatment algorithm A. Participants, upon entry into the study, will require standard first-line therapy. Either oral 5-ASA and/or immunosuppressive (with optional oral corticosteroid in combination) will be initiated.
~Participants will be assessed to determine it remission target is achieved at weeks 16, 32 and 48. If the participant has achieved their treatment target, they will continue that line of therapy. If the participant has not achieved their treatment target, treatment and/or dose escalation will be administered according to the algorithm."
15823112|NCT04259138|Biological|Treatment Algorithm B|"Participants who are taking non-biologic UC therapies at randomization will follow treatment algorithm B.
~Participants will change to intravenous vedolizumab therapy.
~Participants will be assessed to determine it remission target is achieved at weeks 16, 32 and 48. If the participant has achieved their treatment target, they will continue that line of therapy. If the participant has not achieved their treatment target, treatment and/or dose escalation will be administered according to the algorithm."
15823113|NCT04259138|Biological|Treatment Algorithm C|"Participants who are taking anti-TNF, tofacitinib or ustekinumab therapy at randomization will follow treatment algorithm C.
~Participants will change to intravenous vedolizumab therapy.
~Participants will be assessed to determine it remission target is achieved at weeks 16, 32 and 48. If the participant has achieved their treatment target, they will continue that line of therapy. If the participant has not achieved their treatment target, treatment and/or dose escalation will be administered according to the algorithm."
15823114|NCT04259125|Diagnostic Test|Blood draw|Evaluation of plasma inflammatory markers including cytokines and micro-RNA.
15823115|NCT04259125|Other|Survey|Regarding epilepsy and development.
15823116|NCT04259112|Procedure|high pressure|High-pressure pneumoperitoneum is defined as intra-abdominal pressure 12-15 mmHg.
15823117|NCT04259112|Drug|deep neuromuscular block|Deep neuromuscular block is defined as PTC 1-2.
15823118|NCT04259112|Procedure|low pressure|Low-pressure pneumoperitoneum is defined as intra-abdominal pressure 7-10 mmHg.
15823119|NCT04259112|Drug|moderate neuromuscular block|Moderate neuromuscular block is defined as TOF twitch 1-2.
15823120|NCT04259099|Other|Testing the Quality of Life Questionnaire of the European Foundation for Osteoporosis-31(QUALEFFO-31)|Administer the questionnaires to 150 participants to classify their status of quality of life.
15823121|NCT04259086|Drug|DaxibotulinumtoxinA for injection|Intramuscular injection
15823122|NCT04259073|Drug|Pregabalin 150mg|two capsules, one is placebo, the other correspond to pregabalin 150 mg ingested orally one hour before cesarean section
15823123|NCT04259073|Drug|Placebos|two capsules filled with sugar ingested orally one hour before cesarean section
15823124|NCT04259073|Drug|Pregabalin 300mg|two capsules of pregabalin 150 mg ingested orally one hour before cesarean section
15823125|NCT04259060|Drug|Hydroxocobalamin with Butyrate|"In phase 1, patients will take hydroxocobalamin at 1g daily for four weeks. This will be in the form of 1 500mg capsule twice a day. Butyrate will be 240 mg daily in a divided dose (120 mg twice daily) which is 5 pills twice a day.
~In phase 2, the dose of hydroxocobalamin will be increased to 2g daily (1g twice a day) for four weeks pending FDA approval. Butyrate will remain at 240 mg daily in a divided dose (120 mg twice daily) which is 5 pills twice a day. Patients will undergo flexible sigmoidoscopy at baseline and at week four in phase 2."
15823126|NCT04259060|Drug|Placebo with Butyrate|"In phase 1, patients will take 1 placebo capsule twice a day. Butyrate will be taken at 240 mg daily in a divided dose (120 mg twice daily) which is 5 pills twice a day.
~In phase 2, patients will take 2 placebo capsules twice a day, along with butyrate at 240 mg daily in a divided dose (120 mg twice daily) which is 5 pills twice a day."
15823127|NCT04259047|Behavioral|Diabetes Regulation for Eyesight and Memory|Participants randomized to DREAM will have 11 in-home visits over 2 years with a CHW, and 4 telehealth visits with a DM nurse educator.
15823128|NCT04259047|Behavioral|Enhanced Usual Care|Participants in this group will have 11 in-home CHW visits over 24 months to control for attention. During these visits, the CHW will provide general diabetes education. There will be no telehealth visits.
15823129|NCT04259034|Other|diagnosis of periodontitis in oral lichen planus patients|diagnosis of periodontitis in oral lichen planus patients
15823130|NCT04259034|Other|diagnosis of periodontitis in systemically healthy individuals without oral lichen planus|diagnosis of periodontitis in systemically healthy individuals without oral lichen planus
15823131|NCT04259008|Other|Manganese omission|Participants randomized to the experimental intervention arm will not receive added manganese in their parenteral nutrition.
15823132|NCT04259008|Other|"5 mCg/kg/day manganese from Multitrace-4 Neonatal."|"5 mCg/kg/day manganese from Multitrace-4 Neonatal."
15823133|NCT04258995|Biological|Group B streptoccous 6-valent polysaccharide conjugate vaccine (GBS6)|2 formulations at 1 dose level
15823135|NCT04258969|Behavioral|Pedaling|Participants will pedaling at a low-moderate intensity using a stationary pedal ergometer concurrent to their chemotherapy (FOLFOX or FOLFIRI) infusion. Participants will cycle for 30 min within the first 2 hours of their infusion.
15823136|NCT04258956|Drug|Axitinib|"Avelumab 10 mg/kg will be administered every two weeks. Avelumab is administered as a 1-hour iv infusion, diluted with 0.9% saline solution; Axitinib 5 mg should be taken orally twice daily approximately 12 hours apart with or without food. They should be swallowed whole with a glass of water. If the patient vomits or misses a dose, an additional dose should not be taken. The next prescribed dose should be taken at the usual time.
~The duration of treatment cycle is 28 days."
15823137|NCT04258943|Drug|Bosutinib|"Patients with R/I disease are enrolled at a dose of 400 mg/m2 (DL2B) based on tolerability and PK analysis. Once the RP2D for R/I patients (RP2DR/I) is determined in the Phase 1, subsequent patients with R/I disease will be enrolled at the RP2DR/I for this subpopulation for the Phase 2 component of the study (see section 1.6.3 and section 3 for details).
~- Patients with newly diagnosed disease are being enrolled on Phase 2 component only, at RP2DND dose of 300 mg/m2. (see section 1.6.3 and section 3 for details)"
15823138|NCT04258930|Other|Aluminum sulphate and calcium acetate drying soaks|Dilute one envelope of the powder in 500 ml of clean cold water and apply for 10 minutes every 8 hours until completely healed.
15823139|NCT04258930|Device|Topical sterile silicone gel for wounds|Apply a thick layer of silicone gel to all open areas every 8 hours until completely healed.
15823140|NCT04258930|Device|Hydrocolloid dressing|Apply enough hydrocolloid dressings to cover all open areas and change every 2 to 3 days once the dressing becomes saturated (starts to drain around the borders).
15823141|NCT04258917|Device|Axillary Crutch|Standard crutch used in Canada
15823142|NCT04258917|Device|Forearm Crutch|Standard crutch used in United Kingdom
15823143|NCT04258904|Combination Product|Skin Care Program|The intervention consists of a Skin Care Program including neat information regarding dermatological complications to the device use, prevention of these and moisturizer to keep healthy skin.
15823144|NCT04258891|Other|No intervention|Kidney recipients aged over 18 and of all sexes recruited from 2004 in European, North American and South American centers, who have estimated glomerular filtration rate and proteinuria follow-up and data from protocol and for cause biopsies for allograft survival assessment; Randomized controlled trials conducted over the past 20 years with available data on protocol biopsy within the first year and follow-up, clinical, biological and histological data.
15823145|NCT04258878|Procedure|Sternotomy|Procedure: Sternotomy for coronary artery bypass graft, valvuloplasty, aortic surgery or combined procedures, under extracorporeal circulation or not, in emergency or scheduled.
15823146|NCT04258865|Drug|CKD-348 F1|QD, PO
15823147|NCT04258865|Drug|CKD-348 F2|QD, PO
15823148|NCT04258865|Drug|CKD-828, D097, D337|QD, PO
15823149|NCT04258852|Drug|Low strength nicotine e-liquid|Low strength nicotine e-liquid
15823150|NCT04258852|Drug|High strength nicotine e-liquid|High strength nicotine e-liquid
15823151|NCT04258839|Drug|Brexpiprazole|Oral tablet; taken once daily
15823152|NCT04258826|Drug|LY3154207|LY3154207 administered orally.
15823153|NCT04258826|Drug|Placebo|Placebo administered orally.
15823154|NCT04258813|Behavioral|iGuide Intervention (Self-guided)|The iGuide Intervention consists of two patient-level and four PCP-level components. These components include: (1) the patient-level brief video vignettes with a written summary; and (2) patient-facing webinars. The investigators will not use any institutional branding in the videos, printed materials, or recorded webinars so that these deliverables can be used in other settings.
15823155|NCT04258813|Behavioral|iGuide 2 Intervention (Tailored/Targeted)|"The iGuide2 patient-level intervention will use a stage-based, tailored approach to four monthly 5-minute video vignettes that incorporates a pre-video worksheet. The investigators will send the worksheets and video vignettes in the method preferred by the patient.
~The targeted iGuide 2 PCP-level intervention will include a cancer specialist-facing dashboard that includes the specialists's patients who are enrolled in the study and are in the intervention arm. The HEDIS quality measures for our three CVD comorbidities will be used. The dashboard will be populated with data available in Epic for the specific patient. If some information is missing (i.e., there is no lipid profile in the laboratory tab), the dashboard will query the PCP via an e-consult, asking to supply the information. Bimonthly, starting with the second randomization, an asynchronous specialist-to-PCP e-consult will be sent to PCPs whose patient(s) do not meet all three of the HEDIS quality metrics."
15823156|NCT04258813|Behavioral|Control|Participants randomized to the control group (n=400) will receive current guideline-concordant cancer care. The investigators will also provide information for healthy living during and after cancer and for preparing for transition from cancer therapy to follow-up care. Monthly, patient education material on healthy living will be sent to the participants via the patient portal or by mail, based on participant preference. At the completion of therapy, they will be provided the NCI Facing Forward:Life After Cancer booklet. Note, this approach is not fully equivalent to an attention control as there will be touch points in the iGuide and iGuide2 interventions that the investigators cannot match for the control group. Also, the research team will not engage the PCPs in clinics randomized to the control group.
15823157|NCT04258800|Device|Music during colonoscopy|Music during colonoscopy
15823158|NCT04258774|Other|Carbon Dioxide|The study team will administer inhaled carbon dioxide to the participants during an MRI at a level
15823159|NCT04258761|Drug|10XB-101 Solution for Injection|Active test article
15823160|NCT04258748|Behavioral|Motivational Interviewing (MI)|In each of the four MI counseling sessions that were delivered, the researcher approached mothers in small groups of 5 via three phases, in 15-30 minutes, to establish rapport/ alliance in the first phase, to identify health needs in the second phase and finally to reinforce dental needs in the third phase.
15823161|NCT04258748|Behavioral|Gaming and MI|In each of the four MI counseling sessions, the researcher approached mothers via three phases, in 15-30 minutes, to establish rapport/ alliance, to identify and finally reinforce dental needs in the same pattern as MI group. In addition, the children were engaged in 'Happy Teeth, Healthy Kids' which is an android tablet game that was included in the MI session scheduled for the mothers. Children were told to follow correct steps of brushing in order to obtain happy bright teeth. This helped the children realize that brushing teeth will give them a bright smile.
15823539|NCT04255784|Device|Sham iTBS|Fluid-Cooled B70 A/P Coil with either Magventure X100 or R30
15823162|NCT04258748|Behavioral|Conventional dental health education|It was delivered through a 15-minutes oral health session given to mothers of preschoolers. Mothers were given brief information about causes of dental caries and role of plaque, toothbrush size, diet / frequency of sweet snacks, brushing technique, toothpaste and fluoride use as well as regular dental visits. Participants were then shown a short educational video about prevention of dental caries among children coupled with oral hygiene instructions. At the end of the session, participants were given a leaflet reinforcing the information to take home.
15823163|NCT04258735|Diagnostic Test|Genomic analysis|WES, RNASeq, ctDNA, Exosome
15823164|NCT04258722|Other|Resuscitation Personnel|Type of resuscitation team
15823165|NCT04258709|Behavioral|AME|Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video.
15823166|NCT04258709|Behavioral|Video-based infant care education|Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding.
15823167|NCT04258696|Device|diode laser|using Ultrapak Knitted retraction cord as a gingival retraction method . using Wiser Cordless Dental Diode Laser from Doctor Smile Dental Laser By LAMBDA SpA Italy as a gingival retraction method.• The tip of diode laser, will be angled toward the soft tissue and away from the prepared tooth, will be passed along the gingival sulcus to remove the sulcular epithelium. Constant and steady short brushing strokes gently removed the lining of the sulcus in order to achieve a full 360-degree trough. The tip will be constantly cleaned with a gauze sponge wetted with hydrogen peroxide to remove debris and to eliminate potential bacterial contamination. sufﬁcient epithelium will be removed to place the impression material and visualize the ﬁnishing line. The tissue will be kept moist with water during the procedure then impression will be taken
15823168|NCT04258696|Device|ultrapak Knitted retraction cord|using Ultrapak Knitted retraction cord as a gingival retraction method retraction cord will be applied for 8-10 mins then an impression will be taken , poured to obtain a cast and the die sectioned
15823169|NCT04258683|Drug|Pembrolizumab|Patients not progressing after 2 cycles of CyBorD treatment and achieving less than VGPR by IMWG criteria will be screened to receive pembrolizumab intravenously at 200mg at day 1 of every 3-week cycle for 8 cycles (24 weeks) starting Cycle 4 of CyBorD. CyBorD will be discontinued after 24 weeks and pembrolizumab will be administered as a single agent at the same dose for an additional 27 cycles (81 weeks).
15823170|NCT04258670|Other|No intervention|Patients in these cohorts will not be given anti-filariasis therapies because these drugs are not approved for use in patients with high worm burdens (>20,000 Mf/mL)
15823171|NCT04258657|Drug|paclitaxel-albumin and S-1|neoadjuvant chomotherapy with paclitaxel-albumin and S-1 for advanced gastric cancer
15823172|NCT04258644|Drug|Camrelizumab+Apatinib+Paclitaxel-albumin+S-1|Combination therapy of 4 drugs, 21 days for one cycle.
15823173|NCT04258631|Drug|Hydromorphone|Given IT
15823174|NCT04258631|Procedure|Laparotomy|Undergo laparotomy
15823175|NCT04258631|Drug|Liposomal Bupivacaine|Drug
15823176|NCT04258631|Other|Questionnaire Administration|Ancillary studies
15823177|NCT04258618|Behavioral|CBT-I (Cognitive Behavioral Therapy for Insomnia) with rTMS|Cognitive Behavioral Therapy for insomnia (CBT-I) with rTMS (repetitive Transcranial Magnetic Stimulation) will be performed as part of this study by the PI. This includes weekly, one hour sessions addressing sleep for 6 weeks.
15823178|NCT04258618|Device|Repetitive Transcranial Magnetic Stimulation|Participants in this study will be undergoing repetitive transcranial magnetic stimulation (rTMS) for major depressive disorder as part of their clinical treatment. This involves magnetic stimulation with specific settings to a specific region of the brain to help treat depression. Treatment time ranges, but is around 30 minutes per session and occurs 5 days a week for 6 weeks.
15823179|NCT04258605|Device|ASHCOM Shoulder System|Reverse Shoulder Arthroplasty
15823180|NCT04258592|Drug|(18F)MFBG|One intravenous injection of 4 MBq/kg
15823181|NCT04258592|Device|PET/CT|Patients will undergo a dynamic PET scan for the first 30 minutes, followed by 3 static whole-body PET/CTs at 60 ± 10 min, 120 ± 30 min and 180 ± 30 min post injection.
15823182|NCT04258592|Other|Venous blood samples|Blood samples will be obtained for laboratory safety evaluation for initial screening and safety evaluation after injection. Furthermore, venous blood samples will be obtained for metabolite analysis and activity measurements at various time points post injection (5 ± 2 min, 10 ± 5 min, 20 ± 10 min, 40 ± 20 min, 60 ± 30 min, 120 ± 60 min).
15823183|NCT04258579|Behavioral|PROTECT with Technology Augmentation|PROTECT is a therapeutic intervention focused on treating victims of elder abuse who are experiencing depression. PROTECT therapy will be delivered through video. Participants will be provided with a mobile device (iPhone), and a wearable device (smart watch) that will track sleep, mood, steps, and heart rate.
15823186|NCT04258553|Diagnostic Test|Disulphide(μmol/L)|Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with spectrophotometry
15823187|NCT04258553|Diagnostic Test|Total Oxidant Capacity(μmolH2O2Equiv/L)|Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with spectrophotometry
15823188|NCT04258553|Diagnostic Test|Ischemia Modified Albumin(IU/mL)|The serum Ischemia Modified Albumin concentrations were measured as described by Bar-Or et al. (Bar-Or et al. 2000).
15823189|NCT04258540|Behavioral|Yoga group|The intervention group received yoga 2 times a week for 12 weeks (á 1.25 hr).
15823190|NCT04258540|Behavioral|yoga course|yoga course
15823191|NCT04258527|Drug|Pemigatinib|Pemigatinib will be self-administered as at 13.5mg a QD oral treatment on a 2-week-on therapy and 1-week-off therapy schedule.
15823192|NCT04258514|Procedure|Virtual Reality during vasectomy|Virtual Reality
15823193|NCT04258514|Procedure|Standard Vasectomy|No Virtual Reality
15823194|NCT04258501|Other|Mulberry fruit|
15823195|NCT04258501|Other|Mulberry leaf|
15823196|NCT04258501|Other|White bean|
15823197|NCT04258501|Other|Apple|
15823198|NCT04258501|Other|Elderberry|
15823199|NCT04258501|Other|Turmeric|
15823200|NCT04258501|Other|Rice porridge|
15825182|NCT04242758|Drug|Dapagliflozin 10 MG|SGLT2-inhibitor: Diabetic oral drug with diuretic properties
15823203|NCT04258475|Combination Product|Calcium supplementation concurrent to HIV treatment with Raltegravir|PK analysis of different doses of calcium in patients undergoing ART treatment for HIV using Raltegravir.
15823204|NCT04258462|Drug|Hyperpolarized Carbon C 13 Pyruvate|Given IV
15823205|NCT04258462|Procedure|Magnetic Resonance Imaging|Undergo MRI
15823207|NCT04258436|Procedure|Serratus anterior block|Serratus anterior block will be performed using an ultrasound guided transducer to inject 2mg/kg of 0.2% ropivacaine
15823208|NCT04258423|Drug|Tacrolimus|Low dose Tacrolimus
15823209|NCT04258423|Drug|Everolimus|Everolimus
15823210|NCT04258410|Drug|Placebo oral soft chew|placebo identical to experimental drug contained in soft chew
15823211|NCT04258410|Drug|Quercetin|experimental drug contained in soft chew
15823212|NCT04258397|Drug|Pirfenidone|Pirfenidone vs. matching placebo
15823213|NCT04258397|Drug|matching placebo|matching placebo
15823214|NCT04258384|Other|survey application|Data collection tools used in the study; Demographic Data Form, Mcgill and Melzack Pain Questionnaire, Short Form-36 (SF-36), Vanderbilt Multidimensional Pain Coping Inventory (VMPCI), Pain Coping Inventory (PCI), Pain Coping Scale were used.
15823215|NCT04258371|Drug|Dapagliflozin 10 MG|Dapagliflozin Tablets Total Dose 10mg daily for 12 weeks
15823216|NCT04258371|Drug|Placebo oral tablet|Placebo once daily for 12 weeks
15823217|NCT04258358|Other|CASCADE ways of working|Technology, learning and development resources and nursing and therapeutic care are the key drivers for the CASCADE ways of working promoting community integrated dementia care and support to optimise safety and independence for people living with dementia.
15823218|NCT04258345|Other|ASB Feeding Study|Participants will undergo a washout period and then scheduled for blood draw after which ASB feeding period will begin followed by a second blood draw.
15823219|NCT04258332|Dietary Supplement|High Salt Diet|Patients will be randomized to be on a high salt diet for 7 days.
15823220|NCT04258332|Dietary Supplement|Low Salt Diet|Patients will be randomized to be on a low salt for 7 days.
15823221|NCT04258319|Diagnostic Test|Ultrasound Procedure|Ultrasound technique that uses a compression device integrated with ultrasound imaging to perform in vivo ramp-and-hold uniaxial creep-like test on upper extremity lymphedema (UEL) in vivo.
15823222|NCT04258306|Dietary Supplement|Revifast|Revifast® is based on natural resveratrol supported on Magnesium hydroxide. Revifast® particles confer an improved dissolution rate in tests that mimic the gastric environment compared to Polygonum cuspidatum resveratrol (98%).
15823223|NCT04258306|Dietary Supplement|pure resveratrol|resveratrol extracted from Polygonum cuspidatum resveratrol (98%).
15823224|NCT04258293|Diagnostic Test|Blood sampling|fasting venous glycemia, venous glycemia after sugar loading, glycated hemoglobin and platelet count
15823225|NCT04258280|Behavioral|Education and counseling|Education includes a workbook, counseling includes peer support.
15823226|NCT04258280|Behavioral|Education|Education includes a workbook.
15823227|NCT04258267|Procedure|Early mobilization|Patients will wear an adduction sling to immobilize the shoulder during the first 4 weeks post-operative
15823228|NCT04258267|Procedure|Delayed mobilization|Patients will wear an abduction sling to immobilize the shoulder during the first 4 weeks post-operative, followed by an adduction sling for 2 weeks.
15823229|NCT04258254|Behavioral|Multimodal|Multimodal intervention will involve hello songs, warm up mainly involve sensory and stretching games, music time involves playing instruments, moving game involves use of music or songs to move the whole body, yoga involves themes/songs to perform yoga poses, and good bye involves a goodbye song and reflections about the session. In all movement conditions, trainers emphasize complex and multilimb coordination (asymmetrical and ipsi/contralateral movements) and balance.
15823230|NCT04258254|Behavioral|General|The general exercise group will begin with hello games/set up and end with reflections and cleanup. Children will engage in limb and body warmup routines, specific strengthening exercises (single-joint/single-limb/symmetrical), moderate intensity endurance exercises involving various obstacle courses, and a cool down routine.
15823231|NCT04258254|Behavioral|Standard of Care|The seated play group will also begin with hello/icebreaker games and end with goodbye and cleanup. In between, they will read books and review the story line and overall message and engage in fine-motor activities involving building supplies and art-craft.
15823232|NCT04258241|Procedure|Local infiltration analgesia with local anesthetic|The orthopedic surgeon will perform local infiltration analgesia at the end of the surgery. The knee joint capsule, periarticular and subcutaneous tissues will be infiltrated with 150 mg of bupivacaine, 0.3 mg of epinephrine and 90 ml of normal saline.
15823233|NCT04258241|Procedure|Local infiltration analgesia without local anesthetic|The orthopedic surgeon will perform local infiltration analgesia at the end of the surgery. The knee joint capsule, periarticular and subcutaneous tissues will be infiltrated with 0.3 mg of epinephrine and 120 ml of normal saline.
15823234|NCT04258241|Device|Needle|18-gauge 40 mm Sterican needle (B. Braun Medical Inc., Melsungen, Germany) will be used to perform local infiltration analgesia.
15823235|NCT04258241|Drug|Solution with local anesthetic|Solution of 150 mg of bupivacaine, 0.3 mg of epinephrine and 90 ml of normal saline will be used to perform local infiltration analgesia.
15823236|NCT04258241|Drug|Solution without local anesthetic|Solution of 0.3 mg of epinephrine and 120 ml of normal saline will be used to perform local infiltration analgesia.
15823237|NCT04258215|Device|Experimental: Routine positive pressure airway management.|The use of the PSA extraglottic airway for routine general anesthesia will be assessed for quality of airway management by measuring the seal pressure when using the device in 20 participants.
15823238|NCT04258202|Other|Alveolar recruitment maneuver|The two methods for performing an alveolar recruitment maneuver. Alveolar recruitment maneuvers consisted of a stepwise increase in tidal volume to a plateau pressure of 30 cm H2O versus a stepwise increase in PEEP H2O to a plateau pressure of 30 cm H2O.
15823239|NCT04258189|Drug|JNJ-64417184|Single dose of JNJ-64417184 solution (with or without preservatives) will be administered orally.
15823604|NCT04255342|Other|pain|Participants will be asked to report pain in terms of function, comfort and esthetics (PROMs).
15823240|NCT04258176|Other|Multidisciplinary outpatient pathway|Coordinators, assigned to improve the care flow, review and align the patient's appointments and tests in agreement with the patient's wishes. Outpatient consultations are arranged to take place the same day and schedules for care providers are coordinated. The patients' attendance in outpatient clinics are planned sequentially where the delivering specialty writes a summary to the subsequent specialty. Afterwards, the involved physicians and nurses attend an interdisciplinary conference, resulting in a joint treatment plan, with feedback and notice of modifications, which is delivered to the patient and general practice.
15823241|NCT04258163|Drug|Capecitabine|1000-1250 mg/m 2 PO twice daily days 1-14, cycled every 28 days
15823242|NCT04258163|Drug|Liposomal doxorubicin|50 mg/m 2 IV day 1, cycled every 28 days
15823243|NCT04258163|Drug|Gemcitabine|800-1200 mg/m 2 IV days 1, 8, and 15, cycled every 28 days
15823244|NCT04258163|Drug|Fulvestrant|500mg IH Days 0, 14, 28, then every 28 days
15823245|NCT04258163|Drug|Anastrozole|1mg PO qd
15823246|NCT04258163|Drug|Letrozole|2.5mg PO qd
15823247|NCT04258150|Drug|Nivolumab|6 mg/kg IV q4w
15823248|NCT04258150|Drug|Ipilimumab|1 mg/kg IV twice q6w
15823249|NCT04258150|Drug|Tocilizumab|8 mg/kg IV q4w
15823250|NCT04258150|Radiation|SBRT|"A total dose of 15 Gy as a single fraction is prescribed as the mean dose to the PTV.
~PTV should be covered by 95% isodose (PTV D99% > 95%)."
15823251|NCT04258137|Genetic|Liquid biopsy|Liquid biopsy will be performed at cycle 1 day 1 and cycle 2 day of each line of systemic treatment, at each tumor evaluation by Imaging and at confirmation of progression
15823252|NCT04258124|Other|Control motor intervention|The intervention through motor control will consist in the application of the protocol described by Hidalgo-Peréz et al. The objective of the application of the technique is to produce an increase in the strength of the deep cervical musculature. The exercises will be performed with the subject in different positions: supine, quadrupedic and standing position. The physiotherapist will be placed in standing position in front of the subject. The intervention will be carried out in 3 sessions with 3 exercises of 15 repetitions, and with breaks of 40 seconds between each series and exercise.
15823253|NCT04258111|Biological|IBI310 (anti-CTLA-4 antibody)|Specified dose on specified days
15823254|NCT04258111|Biological|Sintilimab(anti-PD-1 antibody)|Specified dose on specified days
15823255|NCT04258098|Drug|Oral antibiotics ( Streptomycin ,metronidazole )|Either polyethylene glycol or magnesium sulphate was adopted as laxative one day before surgery. Clyster was conducted on surgery morning. Streptomycin 1g plus metronidazole 0.2g was prescribed 3 times a day for 3 days before surgery in the OA+MBP group patients.
15823256|NCT04258085|Other|Implementation of electronic medical record in districts implementing breast cancer screening|Electronic medical record used to facilitate documentation, patient tracking across levels of the health care system, and patient contact
15823257|NCT04258085|Other|Early diagnosis program combined with electronic medical record|Implementation of early diagnosis approach targeting symptomatic women, combined with use of electronic medical record
15823258|NCT04258072|Drug|Vactosertib|Vactosertib: 50-mg white round film-coated tablets containing excipients (lactose monohydrate Fastflo 316, microcrystalline cellulose Avicel PH 102, crospovidone Kollidon CL-F, povidone Kollidon 30, magnesium stearate, opadry white) and active pharmaceutical ingredient (N-((4-([1,2,4]triazolo[1,5-a]pyridin-6-yl)-5-(6-methylpyridin-2-yl)-1H-imidazol-2-yl)methyl)-2-fluoroaniline), 10% (w/w) of total weight
15823259|NCT04258059|Device|Active household UV water treatment device|This point-of-entry treatment device will use germicidal UV to treat all of the well water used in the home.
15823260|NCT04258059|Device|Inactive household UV water treatment device|This sham device will use a lamp not emitting germicidal UV.
15823261|NCT04258046|Drug|Trametinib tablet|Drug is supplied in 0.5 mg and 2 mg tablets
15823262|NCT04258033|Drug|PLB1001|PLB1001 is a capsule in the form of 25 mg and 100mg, twice daily.
15823263|NCT04258020|Device|BiPAP|Bilvel Positive Airway Pressure (BiPAP) oxygen administration
15823264|NCT04258020|Device|HFNC|Heated High Flow Nasal Cannula oxygen administration
15823265|NCT04258007|Drug|Reversal Neostigmine|Patients will receive 0.02 mg/ kg atropine and 0.04 mg/ kg neostigmine following observing the second response on stimulating the ulnar nerve on the TOF watch
15823266|NCT04258007|Drug|Reversal Sugammadex|Interventional Arm Patients undergoing cardiac catheterization will receive sugammadex 4 mg/ kg when the T2 is observed on the TOF watch
15823267|NCT04257994|Diagnostic Test|obtaining a buccal smear sample|A sample will be taken from the inside of the participants' cheeks using a soft brush
15823268|NCT04257981|Device|Brain stimulator v3.0|Brain stimulator v3.0 will be used to deliver 1.5 mA current over the scalp corresponding to the primary motor cortex. The current will be delivered via two surface electrodes 5 × 5 cm placed on the scalp, validated by the previous research
15823269|NCT04257981|Other|Sham Comparator: Control group|The sham set-up will follow a similar protocol as the experimental group but the intensity of the current will be ceased after 30 seconds of stimulation. Participants in the Sham group will feel the identical sensation as the experimental group and will be unable to differentiate between actual and sham tDCS such procedure is validated in earlier studies
15823270|NCT04257968|Diagnostic Test|Ultrasonography|carotid ultrasonography (IMT and elastography)
15823271|NCT04257968|Diagnostic Test|MRI|MRI of carotid artery and brain
15823272|NCT04257968|Diagnostic Test|Neuro Psychological Assessment Battery|Hopkins Verbal Learning Test Digit Span WAIS-IV Stroop Color Word test Trail Making Test Brixton Spatial Anticipation Test Fluency letter (B-D-H) Fluency animal naming Symbol Digit Substitution WAIS-IV
15823273|NCT04257968|Diagnostic Test|Questionaires|Cognitive Failures, Depression, Anxiety, Fatigue, Speech handicap, fear for recurrence, Quality of Life.
15823274|NCT04257955|Behavioral|Interview and evaluation of Engagement|(i) the completion of the scheduled outpatients visit (ii) filling of the PHE-Scale® questionnaire by the patient to investigate the level of engagement and (iii) the completion of a semi-structured interview to assess the rate of understanding of the information received from the doctor.
15823275|NCT04257942|Procedure|carotid endarterectomy|carotid endarterctomy that is being used for carotid stenosis disease
15823605|NCT04255342|Other|level of satisfaction|Participants will be asked to report level of satisfaction in terms of function, comfort and esthetics (PROMs).
15823606|NCT04255342|Procedure|debridement|wound will be debrided
15823278|NCT04257916|Other|Experimental|Myofascial technique intervention of the subastragalar joint, kinesiotape and eccentric training with isoinercial machine. The intervention lasted 4 weeks. Each treatment session lasted 50 minutes, with 2 sessions a week. Between training sessions, the indicated break was 48 hours.
15823279|NCT04257916|Other|Manual therapy group|Myofascial technique of the subastragalar joint and eccentric training with isoinercial machine. The intervention lasted 4 weeks. Each treatment session lasted 50 minutes, with 2 sessions a week. Between training sessions, the indicated break was 48 hours.
15823280|NCT04257890|Behavioral|Cognitive behavioral therapy|The CBT focuses on cognitive restructuring to reduce the specific key maladaptive beliefs on Internet gaming suggested by King's model, and develop useful coping skills (self-regulation/control, emotion regulation, problem-solving coping) that are adapted from previous CBT for adolescent IGD. In addition, it provides training on relapse-prevention and maintenance techniques.
15823281|NCT04257890|Other|Education material about IGD|Printed education material introducing IGD will be distributed.
15823282|NCT04257890|Other|Education material about CBT|Printed education material introducing CBT will be distributed.
15823283|NCT04257877|Procedure|Blood sampling|Blood samples for proteomic analysis in plasma of both groups
15823284|NCT04257851|Drug|Theophylline Anhydrous Oral Tablet|Theophylline tablet (150 mg/12h)
15823285|NCT04257851|Drug|Sumatriptan Succinate Oral Tablet|Sumatriptan tablet (25 mg/12h)
15823286|NCT04257838|Drug|Piperacillin/tazobactam or Meropenem|"The plasmatic levels determinations will always be made in state of equilibrium (after the fourth dose) and two samples will be collected:
~Just before the antibiotic infusion (T0)
~In the midpoint of time (T50). If the antibiotic is administered every 8 hours this determination will be made at 4 hours. If the antibiotic is administered every 6 hours, the determination will be made at 3 hours.
~A second complete determination will be made (before the infusion, in the midpoint of time and before the next dose) after the administration of 4 doses as long as a posology modification is made as a consequence of the information received from the plasmatic levels."
15823287|NCT04257825|Device|Chili Sleep System|A mattress pad that cools or warms bed to maintain a constant temperature.
15823288|NCT04257812|Drug|Ceftolozane/tazobactam|"The dose will be 1g ceftolozane + 0,5 g tazobactam every 8 hours or 2 g ceftolozane + 1 g tazobactam, it´s recommended to use this last dose regimen in patients with pneumonia or septic shock of any focus.
~The patients will be followed as it´s done habitually. There will be done infection focus cultures and others according to usual clinical practice. It´ll be determined the clinical response and mortality in the days 14 and 30 after the beginning of the medicine, respectively.
~The Ceftolozane-Tazobactam levels determination will always be made in state of equilibrium (after the third dose). Four samples will be collected:
~Just before the antibiotic infusion.
~One hour after the antibiotic infusion.
~Three hours after the antibiotic infusion.
~Six hours after the antibiotic infusion."
15823289|NCT04257799|Other|Structured Light Imaging (SLI) System|Investigation of SLI and Tomographic Imaging to see if they will identify cancer cells at the edge of tissue specimens removed during the operation.
15823290|NCT04257786|Procedure|1ry cyto-reductive surgery|1ry surgery then chemotherapy
15823291|NCT04257786|Combination Product|Neoadjuvant chemotherapy followed by surgery|chemotherapy then surgery
15823292|NCT04257773|Behavioral|REACH Forgiveness Workbook Intervention|Participants will be asked to complete the REACH Forgiveness Workbook
15823293|NCT04257760|Behavioral|Palliative Care consultation outside standard of care|The ALS patients and their caregivers will receive a consultation with a palliative care physician. This will take approximately one hour and occur in their location of choice (ie. often the patient's home). Subsequent palliative care consultations will occur at the discretion of the ALS patient and the palliative care physician.
15823294|NCT04257747|Other|MRI acquisitions|MRI acquisitions will be performed on the ACHIEVA 3T TX DStream Philips® Research MRI of the GIE Faire Faces.
15823295|NCT04257747|Other|Doppler ultrasound procedure|The Doppler ultrasound procedure will be conducted in the traditional way in the Vascular Medicine Department of the Amiens-Picardie University Hospital
15823296|NCT04257734|Other|observation|different serum antibodies status
15823297|NCT04257708|Diagnostic Test|ultrasound|Transvaginal us to assess the cavity
15823298|NCT04257695|Behavioral|TapPro|Manualized intervention administered by a clinician to facilitate opioid tapering during clinical visits.
15823299|NCT04257682|Drug|Bupivacaine|Bupivacaine is a long-lasting dense sensory-motor block that can last up to four hours. It will be administered once, as part of the spinal anesthetic. The dosage varies based on age and joint, from 6.75 mg to 8.25 mg for the knee, and 7.5 mg to 9 mg for the hip.
15823300|NCT04257682|Drug|Ropivacaine|Ropivacaine is a long-acting local anesthetic that is known for its differential sensory-motor block. It will be administered once, as part of the spinal anesthetic. The dosage varies based on age and joint, from 9 mg to 11 mg for the knee, and 10 mg to 12 mg for the hip.
15823301|NCT04257682|Drug|Mepivacaine|Mepivacaine is an intermediate-acting local anesthetic producing shorting and motor-sparing blocks. It will be administered once, as part of the spinal anesthetic. The dosage varies based on age and joint, from 40 mg to 50 mg for the knee, and 45 mg to 55 mg for the hip.
15823302|NCT04257656|Drug|Remdesivir|RDV 200 mg loading dose on day 1 is given, followed by 100 mg iv once-daily maintenance doses for 9 days.
15823303|NCT04257656|Drug|Remdesivir placebo|RDV placebo 200 mg loading dose on day 1 is given, followed by 100 mg iv once-daily maintenance doses for 9 days.
15823304|NCT04257643|Other|aquatic based exercise.|exercise under water with the patient standing in a swimming pool, for 60 minswith water to the neck and then practice the arm exercise plus the diaphragmatic breathing exercise. The duration of the exercise programs was selected to be 60 minutes, 3 days per week for 8-week intervention
15823607|NCT04255342|Other|oral hygiene|oral hygiene instructions will be given
15825183|NCT04242758|Drug|Hydrochlorothiazide 12.5mg|Best known thiazide class diuretic.
15823305|NCT04257643|Other|land-based exercise.|land-based exercise session for 60 minutes for 8 weeks in the form of warm-up, strengthening, and cooling down exercise.Land-based exercise program: Supervised program consisted of 60-min sessions, three times a week, over 8 weeks. The exercise program consisted of the first 10 minutes for warm-up exercise with a small softball, fit -ball, mobility and stretching exercise. Then 30-40 minutes for strength development with different materials and positions, that require more body control and increase joint motion. Then the last 10 minutes for cooling down for stretching exercise for the arm muscles [14]. Women were asked to exercise continuously for 60 mins, by performing the arm exercises by repeating the session, and were instructed to exercise at moderate intensity .
15823306|NCT04257617|Drug|ZL-1201|Part 1 & 2: Escalating dose of ZL-1201, Part 3: three dose levels determined from Part 1 and Part 2.
15823307|NCT04257604|Drug|Perampanel|Perampanel tablets.
15823308|NCT04257591|Other|hamstring strengthening|A progressive and individualized hamstring strengthening protocol
15823309|NCT04257578|Drug|Acalabrutinib|Given PO
15823310|NCT04257578|Biological|Axicabtagene Ciloleucel|Given IV
15823311|NCT04257565|Device|Wheeled Knee Walker|The Wheeled Knee Walker allows total offloading of a healing limb and may diminish excessive force on the contralateral limb.
15823312|NCT04257565|Other|Usual and Customary Care|This group will receive usual and customary care for treatment of their diabetic foot ulcer
15823313|NCT04257552|Behavioral|Healthy Beyond Pregnancy|Web-based application grounded in tenants of behavioral economics.
15823314|NCT04257552|Behavioral|Pre-Scheduled Postpartum Visit|Participants will have their postpartum visit scheduled while they are still in the hospital after delivery.
15823315|NCT04257552|Other|Attention Control|Participants will receive texts related to infant care to mirror the attention participants receive in the Healthy Beyond Pregnancy intervention.
15823316|NCT04257539|Behavioral|Intervention to Reduce Sedentary Time|Chronic low back pain participants in the intervention group will be provided with a wrist-worn activity device that vibrates after prolonged sedentariness and meet with a health coach trained in motivational interviewing to discuss individual sedentary levels and provide education surrounding sitting habits and strategies for new habit development. Participants will meet with the health coach initially and at 4 weeks during the 8 week intervention period.
15823317|NCT04257526|Behavioral|Diet and lifestyle advice following a positive FIT test and diagnostic colonoscopy.|Participants will be recruited during CRC screening and will be included if they have a positive faecal immunochemical test (FIT) and are diagnosed with adenomas but are CRC negative during the colonoscopy. Participants receive evidence-based diet and lifestyle advice intervention with 'usual care'.
15823318|NCT04257513|Diagnostic Test|Brain MRI|Neurological and Cognitive evaluation; Brain MRI
15823319|NCT04257500|Drug|Etonogestrel/ethinyl estradiol vaginal ring|16 weeks of continuous use of contraceptive vaginal ring
15823320|NCT04257487|Drug|Sulodexide|2 soft capsules of Vessel® 250 LSU BID for 12 months
15823321|NCT04257487|Drug|Sulodexide and placebo|1 soft capsule of Vessel® 250 LSU and 1 soft capsule of placebo BID for 12 months
15823322|NCT04257487|Drug|Placebo|Sugar pill manufactured to mimic sulodexide 250 LSU
15823323|NCT04257474|Behavioral|Self-Report Survey|The self-report survey will be created using the Health Services Utilization Model (HSUM)
15823324|NCT04257474|Behavioral|Qualitative Interviews|Researchers will randomly select 30 participants from group 1 and will use semi structured qualitive interviews exploring factors impacting utilization of screening breast MRI
15823325|NCT04257461|Drug|Fluoropyrimidine|Monotherapy: 12 cycles of 5FU or 8 cycles of Capecitabine. The choice of fluoropyrimidine must be specified prior to randomisation.
15823326|NCT04257461|Drug|Oxaliplatin|Bichemotherapy: Oxaliplatine combined with Fluoropyrimidine.
15823327|NCT04257448|Drug|Romidepsin|Powder and solvent for solution for infusion; Intravenous use
15823328|NCT04257448|Drug|Azacitidine|Powder for suspension for injection; Subcutaneous use
15823329|NCT04257448|Drug|nab-Paclitaxel|Powder for suspension for injection; Intravenous use
15823330|NCT04257448|Drug|Gemcitabine|Powder for solution for infusion; Intravenous use
15823331|NCT04257448|Drug|Durvalumab|Concentrate for solution for infusion; Intravenous use
15823332|NCT04257448|Drug|Lenalidomide capsule|Hard capsule for oral use
15823333|NCT04257435|Behavioral|Positive Psychological Group Treatment|Positive psychological group treatment will involve engagement in traditional behavioral health treatment, as well as a group treatment focusing on previously researched exercises that have been demonstrated to relate to reduced depression and increased positive emotionality (Seligman, Rashid, Parks, et al., 2005; Seligman, Rashid, & Parks, 2006; Rashid, 2015).
15823334|NCT04257435|Behavioral|Traditional Behavioral Health Treatment|Treatment will include traditional individual behavioral health treatment, involving CBT-based therapeutic interventions for presenting diagnoses (typically depression, anxiety, or PTSD-related symptomatology).
15823335|NCT04257422|Other|Intentional Rounding|"A new method of nursing care named Intentional Rounding. The intentional roundings are planned rounds, conducted at regular intervals by nursing staff to anticipate care, comfort, hospitality and psychological needs of hospitalized users."
15823336|NCT04257409|Other|Physical intervention by exercise|12 week lasting exercise intervention
15823337|NCT04257396|Device|Carbon-Fibre Adjustable Reuseable Accessory (CARA)|Breast support device having a carbon-fibre breast cradle for supine patient positioning.
15823338|NCT04257383|Other|Sugira Muryango|"Strong Families, Thriving Children Sugira Muryango is a home-visiting intervention that empowers low-income families enrolled in Rwanda's social protection system to support early childhood development and healthy family functioning."
15823339|NCT04257370|Device|Kerecis™ Omega3 Wound|Kerecis™ Omega3 Wound is decellularised, intact fish skin from North Atlantic cod fish. Kerecis™ Omega3 Wound is FDA approved and EU cleared for the treatment of diabetic ulcers, chronic vascular ulcers, venous ulcers, trauma wounds (including abrasions, lacerations, and skin tears), acute surgical wounds (including debridement, amputation, and donor sites), surgical wounds (dehiscence or failed healing after surgery), imminent failure of STSG, and post-injection necrosis.
15823340|NCT04257370|Other|Standard of care|Standard of care wound treatment as defined by the local site, including debridement of the wound, standard wound dressing, and proper offloading of the wound site.
15823341|NCT04257357|Behavioral|8-weeks supervised exercise program|Please refer to group description
15823343|NCT04257331|Behavioral|Stars and Rain Education Institute for Autism (SREIA) Parent Training Programme|The SREIA program is grounded in applied behavior analysis and developmental theories. It aims to reduce child behavioral problems and promote child development by improving parental attitudes and parenting styles. The program targets parent-child dyads from families of children with ASD aged between three and six years. It is delivered five days a week for 11 weeks. Fourteen two-hour lectures on weekly themes (such as knowledge of ASD, parent-child interaction, and behavior management techniques) are offered throughout the 11 weeks and attended by all participating parents. For the remaining time, additional training in ABA principles and practice are tailored for the different functioning groups. The program offers a combination of individual counselling and group sessions, as well as a mixture of didactic and interactive delivery modes. All sessions are delivered in person. Some sessions are only for parents and others are participated in by both parent and child.
15823344|NCT04257318|Other|Vibrating Relaxation Tool|Use of a Vibrating Relaxation Tool in case of pain during pregnancy
15823346|NCT04257266|Device|Ice Pack Cooling|5 ice packs (Cryo cooling pack or commercial ice pack) will be placed on the subject for 30 mins after exercise-induced hyperthermia
15823347|NCT04257253|Other|Targeted exercise program|Participants in this experimental intervention group will perform a combination of motor control and isolated lumbar extensor strenghtening exercises. The level of difficulty of the exercises will be progressed gradually. The intervention will last 12 weeks, and each participant will have 2 supervised exercise sessions per week.
15823348|NCT04257253|Other|General exercise program|Participants in this active intervention group will perform a generalized exercise program comprising upper-body and lower-body and hip strengthening exercises, as well as flexibility. The level of difficulty of the exercises will be progressed gradually. The intervention will last 12 weeks, and each participant will have 2 supervised exercise sessions per week.
15823349|NCT04257240|Procedure|selective hepatic vascular exclusion|major hepatectomy with vascular control of blood inflow and outflow of the whole liver
15823350|NCT04257240|Procedure|semielective hepatic vascular exclusion|major liver resection by selectively clamping the portal and hepatic vessels only of the lobe harboring the tumor
15823351|NCT04257227|Device|repetitive Transcranial Magnetic Stimulation (rTMS)|"The rTMS intervention will be performed in a dedicated rTMS patient room on the PC unit, where the patient can remain in their bed seated upwards at a 45 degree angle, or seated in a chair.
~The stimulation intensity for treatment will be determined by measuring the resting and active motor threshold (rMT and aMT) using single pulse TMS over the motor cortex using standard techniques as in previous trials. Investigators will use left-sided intermittent theta burst stimulation (iTBS). The trained team member will locate the left DLPFC using the BeamF3 technique. For the open-label dose-finding study, this region will be stimulated intermittently at 3 TMS pulses every 200 milliseconds for 2 seconds (i.e. 30 stimulations). This procedure is repeated every 10 seconds for a total duration of 3 minutes during which 600 total pulses are delivered. Participants will receive up to 8 3-minute sessions daily at 45 minute intervals for 5 days (consecutively or in a seven-day window if need be)."
15823352|NCT04257214|Behavioral|Psychosocial treatment|Participants randomly assigned to one of four psychosocial treatment conditions including cognitive behavioral therapy and a certified recovery specialist.
15823358|NCT04257188|Procedure|minimally invasive vitrectomy under subtenon anaesthesia|The safety and feasibility in terms of tolerance and pain sensation during the surgery as well as the possible perception of light and colour sensations in minimally invasive vitrectomy under sub-tenon anesthesia shall be investigated.
15823359|NCT04257175|Biological|CAR-T CD19|The CAR-T infusion will be given in IV infusion. The target dose is 1 X 106 positive CAR / kg T cells (range: 0.5-1.5X 106 CAR / kg positive T cells).
15823360|NCT04257162|Other|Tumor and Blood sample collection|"This is a non-interventional protocol and does not provide study drug or specific requirements for how the patients should be treated.
~Nevertheless, patients participating in DESTINY trials included in this study are those who were randomized to receive DS-8201a for injection 100 mg Lyo-DP (lyophilized powder) containing 100 mg of DS 8201a in a glass vial reconstituted to a concentration of 20 mg/mL. The starting dose use on such trials is 5.4 mg/kg based on body weight.
~Tumor sample and blood sample will be collected within the framework of HER2-Predict Study"
15823361|NCT04257149|Diagnostic Test|Hemorrhagic stroke group (group A)|Group A: A microwave measurement (Stroke finder MD100) will be performed with the patient lying on the ambulance stretcher, in the hospital bed or another suitable surface.
15823362|NCT04257149|Diagnostic Test|Ischemic stroke group (group B)|Group B: A microwave measurement (Stroke finder MD100) will be performed with the patient lying on the ambulance stretcher, in the hospital bed or another suitable surface.
15823363|NCT04257149|Diagnostic Test|Stroke mimic group (group C)|Group C: A microwave measurement (Stroke finder MD100) will be performed with the patient lying on the ambulance stretcher, in the hospital bed or another suitable surface.
15823364|NCT04257136|Drug|VBI-S|VBI-S is made of small particles of specific lipid called micelles and liposomes for the treatment of hypotension.
15823365|NCT04257123|Device|Gelesis100|Participants will administer Gelesis100 before lunch and dinner meals.
15823366|NCT04257123|Other|Placebo|Participants will administer a placebo before lunch and dinner meals.
15823367|NCT04257110|Drug|BB-1701|BB-1701 will be administered as an intravenous infusion, every 3 weeks.
15823368|NCT04257097|Device|RPM - Osteogenics Lubbock Texas USA|25 patients will undergo bone regeneration with a reinforced PTFE mesh, manually shaped and modelled by the operator during surgery (traditional technique), covered with collagen membranes of medium-rapid resorption
15823369|NCT04257097|Device|Yxoss CBR - Reoss Filderstadt Germany|25 patients undergo bone regeneration with a custom-made titanium mesh, digitally designed by an operator before the surgery (digital technique), covered by collagen membranes with medium-rapid resorption
15823370|NCT04257084|Diagnostic Test|chromoendoscopy with target biopsy; NBI with target biopsy|"Chromoendoscopy with target biopsy: 0.03% indigo carmine solution based chromoendoscopy (using high-definition colonoscopy) will be fulfilled and target biopsies will be taken at all abnormal mucosal lesions suspected dysplasia/neoplasia.
~NBI with target biopsy: After inserting a high definition colonoscopy up to cecum, endoscopists observe the colon in combination of white light and NBI (white light first and then NBI). Target biopsies will be taken at all abnormal mucosal lesions suspected dysplasia/neoplasia."
15823371|NCT04257071|Behavioral|Usual Care|The usual care for MS involves standard patient neurology visits and encounters with pharmacists, financial counselors and social workers if patients need any financial assistance with medication or other expenses.
15823372|NCT04257071|Behavioral|OOP Cost Communication and Optimization|OOP Cost Communication and Optimization includes personalized discussion of OOP cost estimates for treatment plan obtained through an online price transparency tool, personalized analysis of patients' expenses by financial counselor, and patient enrollment in any cost optimization opportunities for which patient is eligible using a comprehensive financial navigation program.
15823373|NCT04257058|Behavioral|Electronic educational material|Electronic media via email
15823374|NCT04257045|Other|Interview|Participate in semi-structure, in-depth qualitative interviews
15823375|NCT04257045|Other|Questionnaire Administration|Complete questionnaires
15823376|NCT04257045|Other|Survey Administration|Complete survey
15823377|NCT04257032|Drug|Rosuvastatin|Tablet
15823378|NCT04257032|Drug|Rosuvastatin + BI 1323495|Tablets
15823379|NCT04257032|Drug|Dabigatran etexilate|Capsule
15823380|NCT04257032|Drug|Dabigatran etexilate + BI 1323495|Capsule and tablets
15823381|NCT04257019|Other|Lavender oil|Inhalation of Lavender oil
15823382|NCT04257019|Other|Almond oil|Inhalation of Almond oil
15823383|NCT04257019|Other|Water|Inhalation of water
15823384|NCT04257006|Device|oXiris membrane|Open heart surgery patients in early postoperative period with clinical signs of fluid overload undergoing CRRT
15823385|NCT04256993|Drug|Radium-223 dichloride (Xofigo, BAY88-8223)|Follow the physician's prescription in routine clinical practice. This study does not involve prescription of the drugs.
15823386|NCT04256993|Drug|Other standard care|Docetaxel, cabazitaxel, enzalutamide, abiraterone and others standard of care following the physician's prescription in routine clinical practice.
15823387|NCT04256980|Drug|Pemigatinib|Pemigatinib will be self-administered at 9mg Or 13.5mg as a QD oral treatment on a 2-week-on therapy and 1-week-off therapy schedule
15823388|NCT04256967|Other|Body and health focused study environment|Students are exposed to lectures, literature, co-students, contexts that provide body and lifestyle awareness beyond the existing exposure of the society in general
15823389|NCT04256954|Behavioral|Peer navigation intervention|A peer navigator will assist those assigned to the intervention group access community mental health, medical care and substance use services. Peer navigators will help create linkages to services
15823390|NCT04256941|Drug|Abemaciclib|Given PO
15823391|NCT04256941|Drug|Anastrozole|Given PO
15823392|NCT04256941|Drug|Fulvestrant|Given IM
15823393|NCT04256941|Drug|Letrozole|Given PO
15823394|NCT04256941|Drug|Palbociclib|Given PO
15823395|NCT04256941|Drug|Ribociclib|Given PO
15823396|NCT04256928|Procedure|Preoperative electrical clipping|Body hair in the operative field will be clipped with an electrical clipper by hospital personnel during preparation to planned surgery.
15823397|NCT04256915|Behavioral|Cognitive Behavioural Therapy for Insomnia (CBT-I) + Bright Light Therapy|"CBT-I consists of 6 weekly sessions of CBT-I (90-min, 3-6 adolescents in each group) with elements that address the behavioural, cognitive and physiological factors perpetuating insomnia, including: psycho-education about sleep and sleep hygiene, stimulus control, sleep restriction, relaxation training, structured worry time, cognitive restructuring (targeting sleep-related dysfunctional cognitions), and relapse prevention.
~Participants will additionally undergo daily morning light therapy by wearing Re-timers (a validated portable light emitting device) at home for 30 minutes. Participants will receive constant blue-green light (500 nm, 506 lux)."
15823398|NCT04256915|Behavioral|Cognitive Behavioural Therapy for Insomnia (CBT-I) + Placebo Light Therapy|"CBT-I consists of 6 weekly sessions of CBT-I (90-min, 3-6 adolescents in each group) with elements that address the behavioural, cognitive and physiological factors perpetuating insomnia, including: psycho-education about sleep and sleep hygiene, stimulus control, sleep restriction, relaxation training, structured worry time, cognitive restructuring (targeting sleep-related dysfunctional cognitions), and relapse prevention.
~Participants will additionally undergo daily morning light therapy by wearing Re-timers (a validated portable light emitting device) at home for 30 minutes.Participants will receive red-filtered dim light (<50 lux)."
15823399|NCT04256889|Device|nfant(R) feeding system|Use of nfant(R) technology feeding system as an adjunct to visual assessment and cue-based feedings for infants born less than 30 weeks GA
15823400|NCT04256876|Device|TTNS|See section 'arms' Stimulation settings: 200 µS, 20 Hz, 1-20 V ( depending of sensory response) Home-therapy: Daily stimulation during 60 minutes.
15823401|NCT04256876|Device|TTNS Sham|See section 'arms'
15823402|NCT04256863|Behavioral|Breakfast / Lunch|Participants in the BFL group will participate in 16 weekly, group based sessions weekly sessions in which they will be exposed to standard behavioral therapy (SBT) for weight control. Each 90-minute session will cover one weight control topic (self-monitoring, modifying the home food environment, physical activity, goal setting, stimulus control, stress-related eating, motivation, problem solving, healthy eating on a budget, social influences and weight loss maintenance) and an experiential learning activity. These hands-on activities will help teens build skills to adhere to 1) their calorie goal (1,400 - 1,600 calories/day) and 2) the prescribed timing for consumption (>50% of their energy needs consumed before 3PM every day of the week. Sample meal plans will be provided to help with adherence. .
15823403|NCT04256863|Behavioral|Dinner (DIN)|Participants randomized to the Dinner (DIN) group will participate in the same 16-week intervention as those in the BFL group; however, the topics covered in the experiential learning session will pertain to skills needed to adhere to prescribed calorie goals NOT to timing. They will be instructed to consume >50% of their energy needs after 3PM daily.; however, given that most teens consume the bulk of their calories after 5PM, the focus will be on general calorie goals vs. timing., Teens in this group will also be provided sample meal plans that outline how to spread out their calorie intake across breakfast (200), lunch (300), after school snack (200 calories), Dinner (700 calories), after dinner snack (200 calories for 1,600 calorie diet only).
15823404|NCT04256850|Behavioral|Acceptance and Commitment Therapy (ACT)|Teaches acceptance, mindfulness, and values-based skills
15823405|NCT04256850|Behavioral|Self-Regulation (SR)|Teaches monitoring and reinforcement strategies designed to improve motivation and adherence to positive weight loss behavioral prescriptions.
15823406|NCT04256837|Device|Transcutaneous electrical auricular vagus nerve stimulation (VNS)|Electrical auricular stimulation is accomplished using a Roscoe Medical TENS 7000 that delivers a programmable electrical current density, frequency, and pulse width. The TENS 7000 will be connected to ear clip (or hand held) electrodes to transcutaneously stimulate the cymba conchae of the ear to activate the auricular branch of the vagus nerve (diagram above), also known as Arnold's nerve, which provides sensory innervation to the skin surrounding the ear canal. Through a neural reflex arc, activation of this sensory nerve sends a neural signal to the brainstem that then activates the efferent vagus nerve through the nucleus of the solitary tract (NTS). This is a well-described and clinically accepted neuromodulatory pathway, as transcutaneous electrical auricular stimulation has been studied to treat seizures, similarly to how invasive electrical vagus nerve stimulation has been approved by the FDA for the past two decades for the same indication.
15823407|NCT04256824|Drug|coated vicryl plus|Coated Polyglactin 910 with Triclosan (coated vicryl plus)
15823408|NCT04256824|Drug|Vicryl|Coated Polyglactin 910 without Triclosan (vicryl)
15823409|NCT04256798|Drug|Chlorhexidine mouthwash|0.2% Chlorhexidine digluconate
15823410|NCT04256798|Drug|Oxygen|Oxygen 80-100%
15823411|NCT04256798|Drug|Oxygen|Oxygen 21-30 %
15823412|NCT04256785|Dietary Supplement|VSL#3|sachets containing probiotic
15823413|NCT04256785|Dietary Supplement|Placebo|sachets containing placebo
15823414|NCT04256759|Drug|Dupilumab 300Mg Solution for Injection|Subcutaneous (SC) dupilumab selected for this study is 300 mg every 2 weeks for 18 weeks.
15823415|NCT04256746|Other|Boiled Rice|
15823416|NCT04256746|Other|Boiled Rice+0.37 gr mulberry fruit powdered extract|
15823417|NCT04256746|Other|Boiled Rice+0.75 gr mulberry fruit powdered extract|
15823418|NCT04256746|Other|Boiled Rice+1.12 gr mulberry fruit powdered extract|
15823419|NCT04256746|Other|Boiled Rice+1.50 gr mulberry fruit powdered extract|
15823420|NCT04256746|Other|Rice Porridge|
15823421|NCT04256746|Other|Rice porridge+1.50 gr mulberry fruit powdered extract|
15823422|NCT04256733|Biological|Supra-threshold and progressive doses of diluted capsaicin via a Koko Digidoser nebulizer|Participants will be exposured to increasing doses of aerosolized capsaicin (a known cough stimulant) through the Koko Digidoser nebulizer, while implementing behavioral cough suppression strategies. The concentration of capsaicin will increase incrementally as tolerated, as long as participants are still able to suppress cough. The concentration will never exceed 1000 micromolar. Participants will attend 6 treatment sessions and be given up to 12 exposures per treatment session. Participants will be encouraged to use cough suppression strategies outside of treatment sessions as much as possible to attempt to suppress cough.
15823423|NCT04256733|Biological|Sub-threshold doses of diluted capsiacin via a KoKo Digidoser nebulizer|Participants will be repeatedly exposed to a sub-threshold dose of aerosolized capsaicin through the KoKo Digidoser nebulizer during treatment sessions. Participants will attend 6 treatment sessions and be given up to 12 exposures per treatment session. Participants will be encouraged to use cough suppression strategies outside of treatment sessions as much as possible to attempt to suppress cough.
15823424|NCT04256720|Behavioral|No intervention|No intervention - questionnaire study
15823425|NCT04256707|Drug|Selinexor 100 mg|"100-mg 2 formulations:
~5 × 20-mg tablets (Tablet A)
~1 × 100-mg tablet (Tablet B)"
15823426|NCT04256707|Drug|Docetaxel|75 mg/m^2 IV
15823427|NCT04256707|Drug|Pembrolizumab|200 mg IV
15823428|NCT04256707|Drug|FOLFIRI|"FOLFIRI:
~Irinotecan 180 mg/m^2
~Leucovorin 400 mg/m^2
~5-FU 400 mg/m^2 bolus
~5-FU 2400 mg/m^2 IV"
15823429|NCT04256707|Drug|Selinexor 40 mg|- 2 × 20-mg tablets (Tablet A)
15823430|NCT04256707|Drug|Selinexor 80 mg|- 4 × 20-mg tablets (Tablet A)
15823431|NCT04256707|Drug|Selinexor 60 mg|- 3× 20-mg tablets (Tablet A)
15823432|NCT04256694|Diagnostic Test|Rapid Antigen Test for Group A Streptococcus|Rapid strep tests will be performed by throat swab of healthy adult volunteers.
15823433|NCT04256681|Other|SNAP questionnaire|The SNAP questionnaire will be administered 2 times in 2 consecutive days to evaluate its reliability. The questionnaire will be self-filled by the patient. Then the SPRS scale and, where possible, the 6MWT will be administered.
15823434|NCT04256668|Diagnostic Test|Obtaining one or semen samples|Through staining of semen samples with sets of dyes to measure features of chromatin density, nuclear morphology and mitochondrial status in large numbers of single spermatozoa and to compare differences in the staining results with known fertility outcome. Through comprehensive comparative epigenetic studies we anticipate to explain different efficiencies of sperm from men with seemingly normal semen quality in driving embryonic development.
15823435|NCT04256655|Drug|cohort 1 0.225g|Drug: CDX 6114 CDX-6114 for oral administration is formulated in phosphate buffer, which also includes mannitol and poloxamer.The vehicle solution provided is identical to the CDX-6114 oral solution except for the active drug. Matching Placebo The placebo oral dosing solution will also be supplied as an oral solution and will be made up of the phosphate buffer diluent and the caramel flavoring.
15823436|NCT04256655|Drug|Cohort 2 0.75g|Drug: CDX 6114 CDX-6114 for oral administration is formulated in phosphate buffer, which also includes mannitol and poloxamer.The vehicle solution provided is identical to the CDX-6114 oral solution except for the active drug. Matching Placebo The placebo oral dosing solution will also be supplied as an oral solution and will be made up of the phosphate buffer diluent and the caramel flavoring.
15823437|NCT04256655|Drug|Cohort 3 2.25 g|Drug: CDX 6114 CDX-6114 for oral administration is formulated in phosphate buffer, which also includes mannitol and poloxamer.The vehicle solution provided is identical to the CDX-6114 oral solution except for the active drug. Matching Placebo The placebo oral dosing solution will also be supplied as an oral solution and will be made up of the phosphate buffer diluent and the caramel flavoring.
15823438|NCT04256642|Procedure|Erector Spinae Plane Block|A nerve block that injects local anesthetic in the Erector Spinae Plane
15823439|NCT04256642|Drug|Intrathecal morphine|Intrathecal morphine at the time of spinal anesthesia
15823440|NCT04256629|Drug|Verinurad|Randomized subjects will receive oral dose of verinurad
15823441|NCT04256629|Drug|Placebo|Randomized subjects will receive oral dose of placebo
15823442|NCT04256629|Drug|Allopurinol|Randomized subjects will receive oral dose of allpurinol (Treatment A and B)
15823443|NCT04256616|Other|This is an observational study that does not concern a direct intervention on patients and control subjects and does not interfere with the clinical management of patients.|"urine collection: DNA is isolated from urine samples (catheterized, washout, midstream) and the 16S rRNA gene is sequenced.
~Specimen collection: Specimens collected during TURBT are selected by a pathologist and trasferred to the laboratory. The tissues are treated ex vivo with MMC."
15823444|NCT04256603|Drug|Gabapentin|Timing of gabapentin initiation
15823445|NCT04256603|Other|No gabapentin|No gabapentin
15823446|NCT04256590|Diagnostic Test|Ultrasonography imaging|This study aimed to measure the tongue surface areas of the patients two times both of study and control groups with ultrasonography imaging to compare the tongue surface areas.
15823447|NCT04256577|Diagnostic Test|serum ceramides level in blood|Serum ceramides ( sphingolipid measurement, plasma (EDTA as anticoagulant) and serum separation was performed immediately after blood drawing by two-time scentrifugation at 750 x g for 5 min (4°C). Lipid extraction from plasma and/or serum samples (10 µl each) and subsequent LC-MS/MS)
15823448|NCT04256564|Procedure|Central venous catheterization|A standard 20 cm (adult-size) 3-port central catheter will be placed to the indicated patients by using standard Seldinger technique (with the assist of a guide wire) under ultrasound guidance
15823449|NCT04256551|Other|Heali mobile application + Registered Dietitian|The Heali mobile application is a dietary resource validated by RD's which uses AI and ML to scan menus and barcodes to provide individuals with information regarding nutritive content and applicability to one's diet using an overall food score and traffic light system. Users have the ability to choose a number of therapeutic diets including LFD, SCD, GERD, and Lectin Free to name a few, but for this study, the app will be isolated to only the LFD. RDs employed by Heali provide real-time messaging to users. For this study, participants will be given access via cell phone login and password (names will not be used). Participant usage information will be de-identified and automatically sent to excel for study authors to perform statistical analysis.
15823450|NCT04256551|Other|Heali mobile application|The Heali mobile application is a dietary resource validated by RD's which uses AI and ML to scan menus and barcodes to provide individuals with information regarding nutritive content and applicability to one's diet using an overall food score and traffic light system. Users have the ability to choose a number of therapeutic diets including LFD, SCD, GERD, and Lectin Free to name a few, but for this study, the app will be isolated to only the LFD. For this study, participants will be given access via cell phone login and password (names will not be used). Participant usage information will be de-identified and automatically sent to excel for study authors to perform statistical analysis.
15823451|NCT04256551|Other|Standard Dietary Education|An educational guide to the implementation of the elimination and reintroduction phases of the diet, a suitable/unsuitable food guide, 19 substitutes for unsuitable foods, a guide of example meals (i.e., breakfast-6 recipes, lunch-8 recipes, dinner-12 recipes, and snacks/beverages-13 recipes), and tips for reading labels and eating a balanced diet while following the LFD. The website is located at http://www.myginutrition.com/news.html and operated by the University of Michigan Health System.
15823452|NCT04256525|Drug|Rivaroxaban 10mg|10mg orally per day
15823453|NCT04256525|Drug|Aspirin 100mg|100mg orally per day
15823454|NCT04256525|Drug|low molecule heparin|0.4ml per day subcutaneous injection
15823455|NCT04256512|Device|Elasto Gel® Therapy Mittens and Foot Wraps|Cold gel therapy mitten and footwrap
15823456|NCT04256499|Procedure|Acute water load test|The acute water load test consists in administering orally 20 mL/kg (of body weight) of water (ingested in less than 30 min) and then follow (during 4 to 6 hours) blood and urine parameters.
15823457|NCT04256486|Behavioral|Family Model Diabetes Self-Management Education and Support|Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a faith based organization setting.
15823458|NCT04256473|Drug|mutant pro-urokinase|Intravenous administration
15823459|NCT04256473|Drug|Alteplase|Intravenous administration
15823460|NCT04256460|Behavioral|Healthy diet, regular exercises and peer support|After assessing the exercise and nutritional status of the participants, health staff in community health centers implemented personalized healthy diet and regular exercises intervention, including coaching on healthy exercises and developing personalized dietary prescriptions for participants. Besides, peer support is implemented as a self management strategy in community health service centers or community self management groups to enhance the behavioral change support for these participants.
15823461|NCT04256447|Diagnostic Test|Urinary sodium concentrations|The urinary sodium excretion was measured using an immunochemical methodology
15823462|NCT04256434|Drug|Dinalbuphine sebacate|150 mg Dinalbuphine sebacate
15823463|NCT04256434|Drug|Nalbuphine HCl|20 mg Nalbuphine
15823464|NCT04256421|Drug|Tiragolumab|Tiragolumab 600 milligrams (mg) administered by IV infusion on Day 1 of each 21-day cycle.
15823465|NCT04256421|Drug|Atezolizumab|Atezolizumab 1200 mg administered by IV infusion on Day 1 of each 21-day cycle.
15823466|NCT04256421|Drug|Carboplatin|Carboplatin was administered by IV infusion on Day 1 of each 21-day cycle for 4 cycles.
15823467|NCT04256421|Drug|Etoposide|Etoposide 100 mg/m^2 administered by IV infusion on Days 1, 2 and 3 of each 21-day cycle for 4 cycles.
15823468|NCT04256421|Drug|Placebo|Placebo administered by IV infusion on Day 1 of each 21-day cycle.
15823608|NCT04255342|Other|Shade selection|definitive shade selection will occur at this appointment, and a final monolithic screwmentable all-ceramic zirconium-oxide crown will be fabricated from the original Atlantis CoreFile
15823469|NCT04256408|Device|Bronchoscopic transparenchymal interlobar fissure closure using Aeriseal|Transbronchial or transparenchymal injection of AeriSeal into the interlobar collateral ventilation channels region to convert CV-positive lobes into CV-negative lobes.
15823470|NCT04256395|Other|mobile internet survey on self-test|1. make a questionnaire, the content of which refers to the new coronavirus diagnosis and treatment guidelines released by the National Health Commission; 2. develop the mobile applet and carry out internet propagation; 3. background data could be identified according to computer technology, de duplication and de privacy; 4. once registered, the applet can automatically remind the self-test twice a day, and encourage to adhere to 14 days; 5. automatically compare with the standards and highly suspected population could be given medical guidance and encouraged to go to the fever clinic of the designated hospital for definite diagnosis.
15823471|NCT04256382|Other|dementia pain care education|Participants are educated about dementia pain care.
15823472|NCT04256382|Other|dementia care education|Participants are educated about dementia pain care.
15823474|NCT04256356|Dietary Supplement|Feeding infants with formula milk with fermented matrix at dosage of 4.6 g per 100g of powder|Infants enrolled were fed either with formula milk with fermented matrix at double dosage or with formula milk with fermented matrix at triple dosage or with standard formula during the first 3 months of life. Breastfed infants were the reference group.
15823475|NCT04256356|Dietary Supplement|Feeding infants with formula milk with fermented matrix at dosage of 6.9 g per 100g of powder|Infants enrolled were fed either with formula milk with fermented matrix at double dosage or with formula milk with fermented matrix at triple dosage or with standard formula during the first 3 months of life. Breastfed infants were the reference group.
15823476|NCT04256356|Other|Feeding infants with standard formula milk|Infants enrolled were fed either with formula milk with fermented matrix at double dosage or with formula milk with fermented matrix at triple dosage or with standard formula during the first 3 months of life. Breastfed infants were the reference group.
15823477|NCT04256356|Other|Breastfeeding infants|reference group
15823478|NCT04256343|Other|Deuterium Oxide (D2O) Dose|1 of 3 differing deuterium oxide (D2O) doses will provided to each of the participants to be consumed daily to assess muscle protein synthesis.
15823479|NCT04256317|Drug|Azacitidine|Tablets for oral administration and powder for reconstitution to aqueous suspension for subcutaneous administration
15823480|NCT04256317|Drug|ASTX030 (cedazuridine + azacitidine)|Tablets for oral administration
15823481|NCT04256317|Drug|Cedazuridine|Tablets for oral administration
15823482|NCT04256304|Behavioral|PHEinAction-Personalized Patient Engagement Plan|"The intervention includes two face-to-face motivational interviewing. The first interview aims to promote an awareness of patients with Type 2 diabetes management, to define an action plan to encourage engagement, to sustain motivation to provide a proactive role in diabetes self-management. After the assessment of patient engagement level (using patient health engagement scale), patients will be encouraged to set engagement goals.
~After the first session, patients will complete home-based paper-pen exercises comprising 12 components (3 exercises, one emotional, one cognitive, and one behavioural; for every of the four engagement levels).
~Two weeks after the first interview, a brief telephone-based coaching encounter will be performed to check the difficulties and to maintain the motivation of the patients.
~Then, a second session will be performed to assess the whole process, to share the experiences and assessment results, to reinforce the positive changes."
15823483|NCT04256278|Other|Spermotrend|oral administration of antioxidants for three months
15823484|NCT04256265|Drug|Risdiplam|Risdiplam will be administered orally once daily
15823485|NCT04256252|Drug|Rituximab|A scheduled therapeutic regimen with low-dose rituximab was performed.
15823486|NCT04256239|Behavioral|Dignity Therapy|Intervention aimed at enhancing patients' sense of personhood, purpose, meaning, and self-worth and reducing psychosocial and existential distress
15823487|NCT04256226|Procedure|Tumor excision|Excision of GIST
15823488|NCT04256213|Drug|Nivolumab and Ipilimumab|"Nivolumab, IV D1C1 and D15C1 (before RT-CT) at 3 mg/kg Every 28 days at 480 mg during 6 months after RT-CT
~Ipilimumab, 1 mg/kg, IV D1C1 (before RT-CT)"
15823489|NCT04256200|Drug|Dienogest 2 MG Oral Tablet|Deinogest (Visanne) 2mg/day, orally for 24 weeks versus combined OCP (Yasmin, 0.03mg
15823490|NCT04256200|Drug|Yasmin|0.03mg Ethinyl Estradiol and 3mg Drospirenone daily for 24 weeks
15823491|NCT04256187|Other|Qualitative interview|Qualitative interviews to sample the patient's feelings, experiences and thoughts risen by the treatments in the program.
15823492|NCT04256174|Drug|AK120 or placebo- Part 1- Cohort 1|Single dose of 15mg AK120 or placebo is administered subcutaneously to healthy subjects
15823493|NCT04256174|Drug|AK120 or placebo- Part 1- Cohort 2|Single dose of 50mg AK120 or placebo is administered subcutaneously to healthy subjects
15823494|NCT04256174|Drug|AK120 or placebo- Part 1- Cohort 3|Single dose of 150mg AK120 or placebo is administered subcutaneously to healthy subjects
15823495|NCT04256174|Drug|AK120 or placebo- Part 1- Cohort 4|Single dose of 300mg AK120 or placebo is administered subcutaneously to healthy subjects
15823496|NCT04256174|Drug|AK120 or placebo- Part 1- Cohort 5|Single dose of 600mg AK120 or placebo is administered subcutaneously to healthy subjects
15823497|NCT04256174|Drug|AK120 or placebo- Part 2- Cohort 1|Multiple low doses of AK120 or placebo are administered subcutaneously as a weekly dose for a total of four doses to subjects with moderate-to-severe atopic dermatitis
15823498|NCT04256174|Drug|AK120 or placebo- Part 2- Cohort 2|Multiple medium doses of AK120 or placebo are administered subcutaneously as a weekly dose for a total of four doses to subjects with moderate-to-severe atopic dermatitis
15823499|NCT04256174|Drug|AK120 or placebo- Part 2- Cohort 3|Multiple high doses of AK120 or placebo are administered subcutaneously as a weekly dose for a total of four doses to subjects with moderate-to-severe atopic dermatitis
15823500|NCT04256148|Biological|ALXN1830|Administered via intravenous (IV) infusion
15823501|NCT04256148|Other|Placebo|Matching placebo (sterile liquid diluent) administered via IV infusion
15823502|NCT04256135|Other|Mulligan mobilization|Mobilization will be performed while the patient actively performs knee flexion and/or extension depending on the patient's painful or limited movements. Three series of ten repetitions will be performed.
15823609|NCT04255342|Other|photographs|Intra-oral photographs will be obtained using a dSLR camera
15823503|NCT04256135|Other|AP Maitland mobilization|The joint mobilization, will be carried out in the knee with both hands, with displacement of the tibia from the front to the back of the femur in an oscillatory way without pain, will be carried out in blocks of 2 minutes with rests of 30 seconds with a duration of about 6 minutes.
15823504|NCT04256122|Other|No intervantion on patients. retrospective study is performed on paraffin embedded tumor tissue specimens routinely collected during TURBT.|evaluate an immunophenotypical profile related to mitochondrial functions in tumors responders vs non-responder to intravescical chemotherapy or immunotherapy. Verify the possible prognostic differences in clinical behavior between the two populations.
15823505|NCT04256096|Device|Thrombectomy|Endovascular treatment of large vessel occlusion (mechanical thrombectomy) with stent-retriever and/or thromboaspiration (neurointerventionalist choice)
15823506|NCT04256083|Biological|Biological analysis|Two blood samples of 4 ml each (total: 8 ml) for IGFBP1 assay and metabolic phenotyping and proteomic analysis.
15823507|NCT04256070|Behavioral|education and tele-consultation|education and tele-consultation based on Watson's Human Care Theory
15823508|NCT04256057|Drug|Magnesium Sulfate|After the induction of anesthesia, a loading dose of magnesium sulfate 50mg/kg in 100mL of isotonic saline as within 5 to 10 minutes(23) followed by a maintenance dose of 10 mg/kg/hr up to the end of surgery
15823509|NCT04256031|Other|Assessment|The structured questionnaire, Visual Analogue Scale, Copenhagen Neck Functional Disability Scale, Shoulder Disability Questionnaire, World Health Organization Quality of Life Instrument-Short Form, and Smartphone Addiction Scale-Short Version will be applied to all participants respectively. Lastly, posture analysis will be performed to all participants by using the New York Posture Rating Chart.
15823510|NCT04256018|Drug|Mogamulizumab|Administered 1 mg/kg as an intravenous infusion over at least 60 minutes on Days 1, 8, 15, and 22 of the first 28 day cycle and on Days 1 and 15 of each subsequent cycle.
15823511|NCT04256018|Radiation|LD TSEBT|Patients will receive total skin dose of 12 Gy fractionated at 4 to 6 Gy per week, for 2-3 weeks
15823512|NCT04256005|Other|Exercise|Participants will complete one of two exercise conditions (50% Delta GET or 105% VO2peak).
15823513|NCT04255992|Dietary Supplement|Calcium Arm|1000 mg Calcium tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.
15823514|NCT04255992|Dietary Supplement|Vitamin D/Calcium|1000 mg/800UI of the association Vitamin D/Calcium tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.
15823515|NCT04255979|Drug|HY209|6 Subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.
15823516|NCT04255966|Device|Plasmafit® Revision Structan®|Plasmafit® Revision Structan® Hip Endoprosthesis Cup
15823517|NCT04255953|Behavioral|behavioral telehealth|Participants will receive 24 weekly group phone counseling sessions. Each session will last approximately 60 minutes and begin with an open-ended check-in question, followed by review of weekly self-monitoring data, question and answer time, and end with a new didactic topic of the week addressing diet, physical activity, or behavior change topics. Participants will be instructed to follow a diet that is reduced to 1200-1500 kcal/day and includes ≥ 5 fruit and vegetable (FV) servings per day, <25% kcal from fat, and 20-30 g of fiber. Physical activity will be gradually increased through a guided home-based program. Throughout the intervention, self-monitoring will be emphasized as a key behavioral weight loss strategy.
15823518|NCT04255953|Other|Treatment as Usual|Treatment as Usual
15823519|NCT04255927|Drug|Coated Vicryl plus|Vicryl plus (Coated Polyglactin 910 with Triclosan)
15823520|NCT04255927|Drug|Coated vicryl|Vicryl (Coated Polyglactin 910 without Triclosan)
15823521|NCT04255914|Procedure|Periodontal plastic surgery procedure and orthodontic treatment|subepithelial connective tissue graft and orthodontic tooth levelling and alignment
15823522|NCT04255914|Procedure|Periodontal plastic surgery procedure|subepithelial connective tissue graft procedure
15823523|NCT04255888|Procedure|Laterally positioned flap in thick periodontal phenotype.|Laterally positioned flap will be performed in isolated gingival recession belonging thick periodontal phenotype .
15823524|NCT04255888|Procedure|Laterally positioned flap in thin periodontal phenotype.|Laterally positioned flap will be performed in isolated gingival recession belonging thin periodontal phenotype .
15823525|NCT04255875|Biological|Placebo|Participants will receive matching placebo
15823526|NCT04255875|Biological|PF-07209326|Participants will receive SC or IV single ascending doses
15823527|NCT04255875|Biological|PF-07209326|SCD participants will receive a multiple dose of subcutaneous PF-07209326
15823528|NCT04255862|Drug|Bimekizumab|Study participants will receive a single-dose of bimekizumab administered subcutaneously in the Treatment Period.
15823529|NCT04255849|Biological|9 valent human papillomavirus vaccine (Types 6, 11, 16, 18, 31, 33, 45, 52, 58)|Gardasil-9 HPV vaccine
15823530|NCT04255849|Other|Saline Placebo|Saline Placebo
15823531|NCT04255836|Drug|Durvalumab|Durvalumab 1500mg q3w combined with chemotherapy for 4 cycles, then 1500mg q4w combined with SBRT, then 1500mg q4w for PD or up to 24 months
15823532|NCT04255836|Drug|the first line chemotherapy for metastatic NSCLC|paclitaxel+carboplatin or pemetrexed+cisplatin
15823533|NCT04255836|Radiation|stereotactic body radiotherapy (SBRT)|SBRT total doses of 50-60Gy/≤10F
15823534|NCT04255823|Other|General practitioner and Patient receive informations related to PPI deprescribing.|"General practitioner will receive a sensibilization and an algorithm related to PPI deprescribing.
~Their patients will receive any informations (patient information material on PPI deprescribing)"
15823535|NCT04255823|Other|Only General practitioner receive informations related to PPI deprescribing.|"General practitioner will receive the sensibilization and an algorithm related to PPI deprescribing.
~Their patients will not receive any informations."
15823536|NCT04255810|Procedure|Surgical collection of biospecimens|Systemic blood and implant capsule tissue will be collected from two cohorts with breast implants, systemic blood only will be collected from Mastopexy cohort
15823537|NCT04255797|Behavioral|baby massage|The steps are as follows:1. Monitor the physiological indicators before massage, 2. Assist premature babies to lie on prone, take off their clothes and diapers, and then apply the baby's massage oil to the hands of both parents to warm them. 3. In the incubator, slight pressure touch the baby's body with warm palms and fingers.
15823538|NCT04255784|Device|Active iTBS|Fluid-Cooled B70 A/P Coil with either Magventure X100 or R30
15823540|NCT04255771|Drug|Gemcitabine|Standard GC (gemcitabine and cisplatin) regimen: gemcitabine 1000-1200mg/m2 intravenous infusion on days 1 and 8, cisplatin 70mg/m2 on the second day of intravenous infusion, every 3 weeks (21-day regimen) is a cycle, A total of 3 cycles.
15823541|NCT04255771|Drug|Placebos|Use a placebo as a comparison
15823542|NCT04255758|Other|Cycle Ergometer Exercise|25 minutes, 70% VO2max steady state cycle ergometry exercise
15823543|NCT04255745|Behavioral|progressive resistance training|Individual, tailored, progressive muscle strength and function intervention
15823544|NCT04255732|Device|extent of retinal area viewing Optos, Daytona, Optos PLC, Dunfermline, UK|Comparison of the extent of retinal periphery view between two wide field imaging devices.
15823545|NCT04255732|Device|extent of retinal area viewing Clarus, 500 Carl Zeiss, Meditec AG, Jena, Germany|Comparison of the extent of retinal periphery view between two wide field imaging devices.
15823546|NCT04255719|Procedure|DBS|Unilateral DBS for treatment of patients with PD
15823547|NCT04255706|Device|biometric measurement IOLMaster 700|Three biometric measurements will be performed with 3 devices for all the patients included
15823548|NCT04255706|Device|biometric measurement Lenstar LS 700|Three biometric measurements will be performed with 3 devices for all the patients included
15823549|NCT04255706|Device|biometric measurement Anterion Heildelberg|Three biometric measurements will be performed with 3 devices for all the patients included
15823550|NCT04255693|Behavioral|diet adherence|"This type of intervention is to be established in a-posteriori analysis by the assessment of a fact whether a subject kept to use his usual diet or it contained substantial changes."
15823551|NCT04255693|Behavioral|No diet adherence|"A-posteriori established intervention based on the examinations at the end-point"
15823552|NCT04255693|Behavioral|Change in physical activity|The changes in physical activity will be assessed a-posteriori based on the examination at the end-point versus baseline data
15823553|NCT04255693|Behavioral|No change in physical activity|The changes in physical activity will be assessed a-posteriori based on the examination at the end-point and comparison to the baseline data
15823554|NCT04255693|Behavioral|Use of antisecretory agents|"This intervention will be established a-posteriori, based on the examination at the end-point and compared to the baseline data. The need for the use of anti-secretory agents depends on the form of GERD and will be on the treating physician discretion. It is principal to account the use of anti-secretory agents (H2-histamine receptors blockers, proton pump inhibitors) as a major factors that may influence the outcomes."
15823555|NCT04255693|Behavioral|No use of antisecretory agents|"This intervention will be established a-posteriori, based on the examination at the end-point and compared to the baseline data."
15823556|NCT04255680|Diagnostic Test|Buccal Swabs and Blood Draws|Buccal Swabs - Frataxin & specific RNA markers Blood Draws - Lipid panel, Uric Acid, Protein Marker Analysis and PAX Gene RNA Analysis
15823557|NCT04255667|Procedure|Eyelid margin crush|after marking eyelid , hemostat is used for eyelid margin incision crush . Then eyelid surgery is done
15823558|NCT04255654|Other|Brief Intervention for Food Insecurity|2 item screening tool (brief intervention)
15823559|NCT04255641|Other|time lapse analysis|grading of the embryos before freezing using time lapse/
15823560|NCT04255628|Diagnostic Test|FDG PET|Cancer patients who scheduled whole body FDG-PET image scan for clinically indicated.
15823561|NCT04255615|Other|AI to analyze 3 D ultrasound|AI to assess 3 D ultrasound to assess antral follicle count
15823562|NCT04255602|Drug|Ticagrelor 60mg|Ticagrelor 60mg plus Aspirin 100mg for experimental group
15823563|NCT04255602|Drug|Ticagrelor 90mg|Ticagrelor 90mg plus Aspirin 100mg for active comparator group
15823564|NCT04255589|Drug|CKD-495 75mg|CKD-495 75mg Tab.
15823565|NCT04255589|Drug|Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg|Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg Tab.
15823566|NCT04255589|Drug|Placebo of the CKD-495 75mg|Placebo of the CKD-495 75mg Tab.
15823567|NCT04255589|Drug|Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg|Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab.
15823568|NCT04255576|Dietary Supplement|Dietary Supplement: Calcium/Vitamin D|All subjects should be adequately supplemented with calcium and vitamin D (at least 500 mg of calcium and 400 IU of vitamin D), except in the case of pre-existing hypercalcemia.
15823569|NCT04255563|Device|DCB treatment|DCB (Sequent® Please) treatment for CAD patients will be enrolled. Intravascular ultrasound (Boston Scientific®) guidance is recommended.
15823570|NCT04255550|Diagnostic Test|Esophageal doppler|It is a prospective observational clinical study to correlate hemodynamic monitoring between non-invasive Electrical Cardiometry and minimally invasive Esophageal Doppler during major abdominal surgery.
15823571|NCT04255524|Device|Optic coherence tomography angiography (OCTA)|Using non-invasive, repeatable, mature device OCTA to obtain choroidal angio-map
15823572|NCT04255511|Device|Twin Block|Functional appliance
15823573|NCT04255511|Device|Fixed orthodontic appliance|Braces
15823574|NCT04255498|Drug|Etanercept|"Perform Phase I study of etanercept (50 mg, once a week for 4 weeks), followed by mifepristone (300 mg, once a day for 7 days), followed by a 10 week observation period and assessment of safety, efficacy and biomarker response to therapy.
~Perform dynamic modeling studies before and after 5 weeks of therapy, repeating the method used previously, in order to document the response to exercise and better quantify the degree of recovery in treated subjects using an exercise challenge and 9 point in time with blood and saliva collections over 24 hours with genomic, cytokine, neuropeptide and cell population studies."
15823575|NCT04255498|Drug|Mifepristone|"Perform Phase I study of etanercept (50 mg, once a week for 4 weeks), followed by mifepristone (300 mg, once a day for 7 days), followed by a 10 week observation period and assessment of safety, efficacy and biomarker response to therapy.
~Perform dynamic modeling studies before and after 5 weeks of therapy, repeating the method used previously, in order to document the response to exercise and better quantify the degree of recovery in treated subjects using an exercise challenge and 9 point in time with blood and saliva collections over 24 hours with genomic, cytokine, neuropeptide and cell population studies."
15823610|NCT04255342|Procedure|plaque removal|removal of plaque on crown and surrounding teeth
15823611|NCT04255342|Other|probing depth|probing depths will be measured
15823612|NCT04255342|Other|Bleeding on probing|bleeding on probing will be recorded
15823576|NCT04255472|Behavioral|WHO Caregiver skills training (CST) program|Caregivers are provided with tangible strategies to appropriately respond to their children's emotional regulation, engagement, and communication. Further, the program focuses on helping caregivers to develop their children's communication and adaptive skills while reducing challenging behavior by focusing on identifying the function of the behavior and learning to teach developmentally appropriate replacement skills. The WHO CST program includes nine group sessions delivered at a community venue (e.g., BHU, school, home) and three home visits: the first at entry prior to session 1, the second after session 4, and the third after the final group session. Training for program facilitators will be included prior to the delivery of the intervention.
15823577|NCT04255472|Behavioral|Treatment as usual|WHO CST will be compared with TAU. TAU in primary healthcare centers for childhood developmental disorders and delays usually consists of no treatment, or a range of alternate treatment regimes, such as multi-vitamin syrups and tablets. Evidence-based mental health care is currently not available in primary healthcare centers. A complete record of services availed by the trial participants at tertiary mental healthcare center will be maintained by using an adapted Client Services Receipt Inventory (CSRI) for children with developmental disorders and delays at baseline and end point.
15823578|NCT04255459|Other|Moist Snuff|Moist Snuff product
15823579|NCT04255459|Other|Camel Snus|Camel Snus product
15823580|NCT04255459|Other|Cigarettes|Cigarette product
15823581|NCT04255459|Other|No tobacco usage|No tobacco usage
15823582|NCT04255446|Device|Thora3DiTM|Not international
15823585|NCT04255420|Procedure|SPG Block|A cotton-tipped applicator soaked in 1% lidocaine will be inserted into the nostril on the side of the headache. If the headache is bilateral, two cotton-tipped applicators will be inserted. The cotton-tipped applicators will be left in place for 15 minutes.
15823586|NCT04255420|Drug|Standard IV Treatment|Intravenous prochlorperazine 10 mg plus diphenhydramine 50 mg will be administered.
15823587|NCT04255407|Device|I-ONE® therapy|I-ONE® therapy will be used in patients with bone bruise on the knee after anterior cruciate ligament (ACL) injury 15 days before and 60 days after ACL reconstruction surgery for 4 hours a day compared to a control group (no-treatment).
15823588|NCT04255407|Drug|Anti-inflammatory drug|Pain before and after ACL reconstruction will be managed with common anti-inflammatory drugs (Paracetamol)
15823589|NCT04255381|Device|Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)|Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP)
15823590|NCT04255368|Other|Water-soluble choline|600 mg choline as choline bitartrate
15823591|NCT04255368|Other|Fat-soluble choline|600 mg choline as phosphatidylcholine
15823592|NCT04255368|Other|No choline control|No choline
15823593|NCT04255355|Other|Pelvic alignment and forceful expiration|"The participant will be in supine with feet flat on a wall and the knees and hips flexed to 90 degrees. A standard 5 ball will be placed between the knees. The participant will hold a standard 9-inch balloon in the mouth with one hand. The subject will be instructed to isometrically contract the hamstrings to lift the ischium off the table while maintaining a posterior pelvic tilt. In this position, subject will be instructed to perform isometric hip adduction by squeezing the ball placed between the knees. The subject will then be instructed to breathe in through the nose and blow the air out into the balloon with full exhalation to activate the transverse and oblique abdominals. The participant will hold the breath for 3 seconds while maintaining hamstring contraction, adductor contraction, and transverse and oblique abdominal contraction. This process will be repeated four times. This exercise will be performed once daily under the supervision of the therapist for 5 days."
15823594|NCT04255355|Other|Pelvic repositioning exercise|The participant will be positioned supine with their feet flat on a wall and the knees and hips flexed to 90 degrees. The subject will be instructed to isometrically contract the hamstrings to allow the ischial tuberosities to lift off the table while also maintaining a posterior pelvic tilt. The tailbone should be slightly lifted off the table, the abdominal muscles should be relaxed, and the low back should be flat on the table. While maintaining the posterior pelvic tilt, the subject will be instructed to perform isometric hip adduction by squeezing the ball that is placed between the knees. The subject will hold for 3 seconds and then relax. This process will be repeated four times. This exercise will be performed daily under the supervision of the therapist for 5 days.
15823595|NCT04255355|Other|Diaphragmatic breathing exercise|For diaphragmatic breathing exercise, the subject will be in supine position. The investigator places both hands around the participant's lower ribs and abdominal area. The investigator applies slight manual resistance to the chest and abdominal wall during inhalation phase of breathing.The participant is instructed to apply outward pressure against the investigator resistance and to raise the chest and abdominal wall simultaneously with inhalation. Then participants performs a full exhalation and hold his/her breath for 3 seconds before breathing in again. This process is repeated for 4 breathing cycles. Participants will perform this exercise once a day under investigator supervision.
15823596|NCT04255342|Device|Atlantis Abutment|A gold-hue titanium Atlantis abutment will be connected and secured to the implant fixture, and a provisional screwmentable PMMA crown seated to verify marginal adaptation, proximal contact intensity, and occlusion. Upon any necessary modifications and adjustments to the provisional crown, the abutment and crown will be cemented extraorally, disinfected ultrasonically in 0.12% chlorohexidine gluconate, and torqued to 25N/cm2, and screw-access channel obturated with polytetrafluorethylene (PTFE) tape and resin composite.
15823597|NCT04255342|Procedure|Intra-oral photographs|Intra-oral photographs of the sites of interest will be obtained
15823598|NCT04255342|Device|provisional crown (te + 12 weeks)|modifications and adjustments to the provisional crown, the abutment and crown will be cemented extraorally, disinfected ultrasonically in 0.12% chlorohexidine gluconate, and torqued to 25N/cm2, and screw-access channel obturated with polytetrafluorethylene (PTFE) tape and resin composite.
15823599|NCT04255342|Other|medical history|medical history updated to medical record
15823600|NCT04255342|Other|dental history|dental history updated to medical record
15823601|NCT04255342|Procedure|suture removal|sutures will be removed
15823602|NCT04255342|Procedure|intra-oral digital scan|An intra-oral digital scan of the arch will be obtained using an intra-oral scanner
15823603|NCT04255342|Diagnostic Test|wound healing index|Visual assessment of the healing status will be made using a wound healing index (WHI)
15823617|NCT04255342|Device|provisional crown (te + 24 weeks)|modifications and adjustments to the provisional crown, the abutment and crown will be cemented extraorally, disinfected ultrasonically in 0.12% chlorohexidine gluconate, and torqued to 25N/cm2, and screw-access channel obturated with polytetrafluorethylene (PTFE) tape and resin composite.
15823618|NCT04255342|Device|provisional crown (te + 36 weeks)|modifications and adjustments to the provisional crown, the abutment and crown will be cemented extraorally, disinfected ultrasonically in 0.12% chlorohexidine gluconate, and torqued to 25N/cm2, and screw-access channel obturated with polytetrafluorethylene (PTFE) tape and resin composite.
15823619|NCT04255329|Other|Montessori reading roundtable|Such book is written in a way to adaptate to people with cognitif and sensory impairments. Indeed, text is written in large characters and structured to not involve episodic memory. Each person read one page aloud in his turn. After the reading phase, the participants discuss the questions about their opinions and distant memories.
15823620|NCT04255329|Other|Usual reading|The readen text is a normal, currently used in a everyday life support such as a journal article.
15823621|NCT04255316|Procedure|Modified method of eversion carotid endarterectomy|Mini approach for CCA bifurcation - Clamping ICA, ECA and CCA - ICA is cut off with a scalpel at the mouth itself - Dissection of the ICA and ECA in the distal direction to the distal border of the atherosclerotic plaque - Endarterectomy - Performing of a new bifurcation of the CCA with prolene 7/0
15823622|NCT04255316|Procedure|Standard method of eversion carotid endarterectomy|standard eversion technic
15823623|NCT04255303|Other|Integrated clinical prediction rule (iCPR) system (iCPR)|The iCPR tool consists of an electronic calculator that can be used to determine whether the patient is at low, intermediate or high risk for having the diagnosis and a bundled order set. When a provider at an intervention group clinic enters data in the EHR that may indicate a patient has strep throat or pneumonia, the iCPR tool will be triggered and the provider will see a best practice alert recommending that they use the iCPR too. The iCPR tool through the use of order sets will guide the provider in the patient's care. The order set for patients at low risk for these diseases will recommend supportive care including over the counter cold remedies and pain relievers. At intermediate risk of these disease will recommend diagnostic tests to help determine if they have the disease. At high risk will recommend antibiotics. The provider can decline to use the tool at any time while working in the EHR.
15823624|NCT04255290|Other|Leg Squat Lounge|The players assigned to the experimental group will receive an intervention through plyometric and eccentric hamstring exercises
15823625|NCT04255290|Other|Control group|The subjects included in the control group will perform an eccentric work protocol
15823632|NCT04255251|Drug|Silver Diammine Fluoride|Subjects will receive SDF around their crown margins every 6 months for next 3 years.
15823633|NCT04255251|Drug|Fluoride Varnishes|Subjects will receive SDF around their crown margins every 6 months for next 3 years.
15823634|NCT04255238|Drug|Gemigliptin 50mg|The subjects should visit a study site 6-7 times during the treatment period for about 24 weeks in total. - Background therapy should be administered keeping the same dosage administered before the study, according to the following criteria: Metformin ≥ 1,000 mg / day
15823635|NCT04255238|Drug|Dapagliflozin 10mg|The subjects should visit a study site 6-7 times during the treatment period for about 24 weeks in total. - Background therapy should be administered keeping the same dosage administered before the study, according to the following criteria: Metformin ≥ 1,000 mg / day
15823636|NCT04255225|Behavioral|Walking for 10 minutes|Participants will walk on a treadmill for 10 minutes at a moderate intensity.
15823637|NCT04255225|Behavioral|Walking for 20 minutes|Participants will walk on a treadmill for 20 minutes at a moderate intensity.
15823638|NCT04255225|Behavioral|Walking for 30 minutes|Participants will walk on a treadmill for 30 minutes at a moderate intensity.
15823639|NCT04255212|Other|Soft tissue treatment|Participants will be asked to sit in front of a medical table with their forearms supinated and relaxed. 5 minutes of deep tissue manual flossing on the proximal and medial aspect of the forearm of each side will be administered by keeping the hands contact on the skin of the participants for all the treatment duration. Direction of the gentle repeated manual compressions and shifts will be proximal to distal or vicerversa depending on the symptom reduction reported by the participants. Stimuli frequencies will be about 0,2-03 Hz. Subjects will be instructed to report immediately if the manual treatment starts to induce an increase in symptoms
15823640|NCT04255212|Other|Mechaninsms explanation|Participants will be instructed with a 10 minute lesson on mechanisms hypothesized to generate Delayed Onset Muscle Soreness. To trigger the most the bottom down pain modulation given by the placebo effect lesson will be concluded stressing the fact that DOMS have a good prognosis and that in a short amount of time they will be pain free and also that no drugs are effective to reduce pain intensity in DOMS condition suggesting them to stay physically active.
15823641|NCT04255212|Other|Anatomy and human upper limb functions|Participants will be instructed with a 10 minute lesson on anathomy of the upper limb and on upper limb functions in human evolution. It will be explained that human upper limb has the unique ability to throw objects stronger and faster than any other animal on the planet and also that compared to the monkeys is not properly developed for climbing. Human world records of single finger pull and double hands pull will be presented.
15823642|NCT04255199|Behavioral|Control|Clinicians randomized to the control group will receive a single visit with a standardized patient instructor (SPI) scheduled during usual office hours. SPIs will portray a patients with acute back pain but will deliver no formative training or feedback to the primary care physicians randomized to the control arm.
15824133|NCT04251247|Diagnostic Test|D-dimer/fibrinogen ratio|The ratio of D-dimer (ng/ml) to fibrinogen (mg/dl)
15823643|NCT04255199|Behavioral|Intervention|Clinicians randomized to the intervention group will receive 2-3 visits with a standardized patient instructor (SPI) scheduled during usual office hours over ~3 month period. For intervention physicians, SPIs will portray patients with acute back pain and will provide formative feedback to physicians and specific instruction in communication techniques to facilitate patient acceptance of a watchful waiting strategy with respect to spinal imaging. The specific communication techniques and sequence will be determined based on pre-trial literature review, patient focus groups, and interviews of primary care physicians who will not participate in the trial.
15823644|NCT04255186|Device|Thermal 448 kHz Capacitive Resistive Monopolar Radiofrequency|Thermal Application of 448 kHz monopolar radio frequency in capacitive and resistive method
15823645|NCT04255186|Device|Subthermal 448 kHz Capacitive Resistive Monopolar Radiofrequency|Subthermal Application of 448 kHz monopolar radio frequency in capacitive and resistive method
15823646|NCT04255186|Device|Sham stimulation|a simulated stimulation protocol so that the device does not emit current
15823647|NCT04255173|Diagnostic Test|Body mass index|Body mass index is calculated as a ratio of height and weight, expressed as kg/m2
15823648|NCT04255173|Diagnostic Test|waist circumference|waist circumference is measured as cm
15823649|NCT04255173|Diagnostic Test|hip circumference|hip circumference is measured as cm
15823650|NCT04255173|Diagnostic Test|height|height is measured as cm
15823651|NCT04255173|Diagnostic Test|Fat percentage|Fat percentage and skeletal muscle mass (SMM) was calculated by using bioimpedance analysis (BIA) (Tanita TBF 300; Tanita Corp., Tokyo, Japan).
15823652|NCT04255173|Diagnostic Test|Skeletal muscle index|Skeletal muscle index (SMI) was calculated from BIA-based skeletal muscle mass with a formula as SMM/height [m2].
15823653|NCT04255173|Diagnostic Test|A body shape index (ABSI)|ABSI is measured as waist circumference (m) / (BMI(kg)2/3x Height(m)5/6)
15823654|NCT04255173|Diagnostic Test|Dual energy x ray absorptiometry (DXA)|Osteoporosis is diagnosed with DXA scores. According to the T-scores calculated from femur neck (FN) and lumbar spine (LS), subjects divided into 3 groups as following: a) normal: T-score is greater than -1 SD (standard deviation), b) osteopenia: T-score is between -1 and -2.5 SD, c) osteoporosis: T-score is lower than -2.5 SD.
15823655|NCT04255173|Diagnostic Test|The Rapid Assessment of Physical Activity (RAPA) aerobic assessment|Physical activity levels of patients were evaluated with The Rapid Assessment of Physical Activity (RAPA) aerobic assessment. Patients divided into 5 groups as following: 1 = sedentary, 2 = underactive, 3 = regular underactive (light activities), 4 = regular underactive, and 5 = regular active).
15823656|NCT04255160|Drug|Estradiol (mylan or vivelle dot patch)|Transdermal estradiol (0.1mg/day patch) will be used by women for 7 days. Administration of the patch will follow the package guidelines to change the patch after 3-4 days of use.
15823657|NCT04255160|Other|Placebo|A placebo patch that is visually similar to the estradiol patch will be used for the group not receiving estradiol.
15823658|NCT04255147|Biological|Allogeneic Umbilical Cord Tissue-Derived Mesenchymal Stromal Cells|Cryopreserved allogeneic umbilical cord tissue-derived mesenchymal stromal cells are thawed and administered intravenously.
15823659|NCT04255134|Drug|Abatacept Injection|Subjects will be randomized to treatment with either abatacept or adalimumab
15823660|NCT04255134|Drug|Adalimumab Injection|Subjects will be randomized to treatment with either abatacept or adalimumab
15823661|NCT04255121|Drug|2% adrenaline lidocaine associated with 4.2% sodium bicarbonate|conversion of epidural analgesia into epidural anesthesia during an emergency caesarean using an alkalinization of adrenaline lidocaine solution
15823662|NCT04255121|Drug|2% adrenaline lidocaine|conversion of epidural analgesia into epidural anesthesia during an emergency caesarean using an adrenaline lidocaine solution
15823663|NCT04255108|Device|Cova Patch|CoVa Patch will measure quasi-continuously, approximately every 5 minutes for a period between 6 to 48 hours
15823664|NCT04255095|Procedure|experiment|Treatment was randomly selected according to preoperative grouping. After ERCP, naso-pancreatic drainage was chosen as treatment。
15823665|NCT04255095|Procedure|control|Treatment was randomly selected according to preoperative grouping. After ERCP, nasobiliary drainage was chosen as treatment。
15823666|NCT04255082|Other|assess the impact of mindfulness-based interventions on inpatients' and outpatients' stress, patient-provider communication, and other measures of SDM at MDMC.|"Effectiveness of the mindfulness-based intervention which will be assessed by:
~Baseline and post-intervention perception of stress and anxiety Impact of stress on communication Emotional/Brain state Level of SDM during a pivotal visit with provider e.g. treatment planning visit (for outpatients only) The Emotional Distress-Anxiety (PROMIS, 2016), Communication Short Form (Cella, PROMIS, 2013), Emotional/Brain State Question (Mellin, 2017) and The Shared Decision Making dyadic OPTION scale (Melbourne, 2016) will be used to evaluate these outcomes.
~Feasibility of such a study in the patient population and setting. This will be measured by the barriers encountered and the ability to successfully carry out the study."
15823667|NCT04255069|Drug|Placebo|A treatment with dose 1 JKB-122, dose 2 JKB-122 or placebo will be randomly administrated once daily
15823668|NCT04255069|Drug|Dose 1 JKB-122|A treatment with dose 1 JKB-122, dose 2 JKB-122 or placebo will be randomly administrated once daily
15823669|NCT04255069|Drug|Dose 2 JKB-122|A treatment with dose 1 JKB-122, dose 2 JKB-122 or placebo will be randomly administrated once daily
15823670|NCT04255056|Drug|Pyrotinib|"Pyrotinib is administered orally at 400 mg daily from day 1 of the first cycle to day 21 of the fourth cycle or to the day of surgery, within 30 minutes after breakfast.
~Epirubicin (90 mg/m2), intravenously, every 21 days. Cyclophosphamide (600 mg/m2), intravenously, every 21 days."
15823671|NCT04255043|Device|IVUS guidance|IVUS (Boston Scientific®) guidance + DCB (Sequent® Please) treatment
15823672|NCT04255043|Device|Angiography guidance|DCB (Sequent® Please) treatment
15823715|NCT04254679|Drug|Non-opioid analgesics|"Prescription of around-the-clock non-opioid analgesics (acetaminophen alone or combined with NSAIDs/COX-2).
~The specific non-opioid analgesia regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference."
15823717|NCT04254653|Behavioral|American Indian and Alaska Native What Can I Eat?|Participants will engage in 5 ~90 minute diabetes nutrition education classes. They will learn about healthy eating for type 2 diabetes management. Classes include didactic lesson, hands on learning activity, sharing session, mindful nutrition practice, and physical activity
15823673|NCT04255030|Behavioral|Coping Together Booklets and Workbook|Dyads in this group will complete Coping-Together, a 6-week, booklet-based, self-directed coping and self-management skills training intervention. This intervention addresses key psychosocial challenges by offering evidence-based practical skills to: (a) manage symptoms, (b) cope with anxiety, (c) collaborate with the health care team, (d) engage in shared decision-making, (e) communicate with partner and family, and/or (f) obtain the community resources needed. A relaxation CD is also included, in addition to a workbook that accompanies the Coping-Together booklet-based intervention. The workbook aims at helping dyads choose a booklet relevant to their cancer-related challenges faced, find coping skills that best meet these challenges, and make a plan to use one of the coping skills successfully.
15823674|NCT04255030|Behavioral|Lay telephone coaching|Dyads will receive Coping-Together support via weekly telephone calls from a lay coach. Sessions will range between 10-15 minutes. The goal of coaching will be to provide information on how to use the workbook and booklets. Although no formal therapy will be provided, the coach will maintain a positive and encouraging attitude when interacting with participants regardless of their adherence to the intervention recommendations. The sessions will start with the coach setting a predetermined agenda based on the section of the workbook to review that week that week. Then, coaches will ask about the use of the booklets over the previous week, and ask participants about any required support or clarification in using the booklets. Sessions conclude with setting a goal related to the workbook, booklets and/or coping technique to focus on over the coming week.
15823675|NCT04255030|Behavioral|Motivational Interviewing|Six, 45-60 minute weekly telephone-based sessions with a trained Motivational Interviewing Specialist to progress toward goals. Here, dyads are given one-on-one guidance from a HCP Motivational Interviewing Specialist to practice the skills they need. Calls will focus on problem-solving principles and core components of self-management (70), including: (a) identifying dyads' concerns, (b) reviewing management efforts, (c) identifying goals, (d) identifying skills needed to achieve goals, and (e) addressing barriers to applying skills to current situations, including level of self-efficacy. At each meeting, progress, subsequent goals, and corresponding plans will be discussed.
15823676|NCT04255017|Drug|Abidol hydrochloride|Abidol hydrochloride (0.2g once, 3 times a day,2 weeks)was added on the basis of group I.
15823677|NCT04255017|Drug|Oseltamivir|Oseltamivir(75mg once, twice a day,2 weeks) was added on the basis of group I.
15823678|NCT04255017|Drug|Lopinavir/ritonavir|Lopinavir/ritonavir (500mg once, twice a day,2 weeks)was added on the basis of group I.
15823679|NCT04255004|Device|Pall Celeris System, point of care device for human cell therapy|Concentration of PB-MNCs autologous cell therapy was produced by a filtration-based point-of-care device. All the procedures were performed in operatory room with anaesthesiologic support (propofol and/or peripheral block). Blood withdrawal (120 ml) was collected through a peripheral venous access. Blood was loaded, and gravity filtration was allowed to proceed until the upstream side of the filter had no remaining blood; filtration last about 10 minutes. During filtration, MNCs were captured in the filter while plasma, platelets (PLTs) and red blood cells (RBCs) were not retained. Immediately concentrate solution is injected in the perilesional area and intramuscular in the foot and the leg (0.2-0.3cc in boluses) below the knee, at intervals of 1-2 cm and to a mean depth of 1.5-2 cm, using a 21G needle. This procedure is repeated on each patient for three times, at intervals of 30-45 days from each other.
15823680|NCT04254991|Diagnostic Test|ImmunoXpert™|The ImmunoXpert™ technology employs a biochemical assay that measures a proprietary combination of three biomarkers of the immune system coupled with pattern recognition algorithms that classify the source of an infection as bacterial or viral
15823681|NCT04254978|Drug|IMG-7289|LSD1 inhibitor
15823682|NCT04254965|Other|Music therapy|Treatment including instrument playing, singing, lyrics modification/music organized play, listening to music and discussing each treatment process.
15823683|NCT04254965|Device|Biosignal analysis|Measurement of facial expression emotion recognition, electrodermal activity, heart rate variability, sleep pattern, blood pressure, and electromyogram.
15823684|NCT04254939|Drug|CS3007 (BLU-285)|"A modified 3+3 dose escalation design will be adopted. Each group will enroll 3-6 subjects. Avapritinib will be administered orally at the starting of 200 mg QD. A cycle consists of 28 consecutive days."
15823685|NCT04254926|Behavioral|Revie ⊕|Revie ⊕ is a positive approach centered on the resources and strengths of the patient, and it consists of an intervention that focuses on the individual's life review. Revie ⊕ allows specialist nurses to discuss life events with cancer patients, to identify the significant elements, and to explore how the diagnosis has changed their values and preferences. The intervention is geared toward working with the patient to discover their potential, to identify their strategies for coping with the events of their life, and to thereby accompany them in achieving a better understanding of themselves and what defines their identity. The intervention also allows their concerns surrounding death to be addressed, in addition to providing clarity in regard to the life projects. In the end, as a conclusion to the intervention, the patient is provided a booklet recounting the salient features of their life review along with photographs, quotes, or images.
15823686|NCT04254913|Drug|MT-1186|Suspension
15823687|NCT04254900|Other|evaluating energy availability|energy availability will be determined by measuring energy intake, exercise energy expenditure and fat-free mass and using the following formula: energy availability = (energy intake - exercise energy expenditure) / fat-free mass
15823688|NCT04254887|Procedure|EPBD|Small incision of the duodenal nipple + EPBD
15823689|NCT04254887|Procedure|EST|Large incision of the duodenal nipple + EPBD
15823690|NCT04254874|Drug|Abidol hydrochloride|0.2g once, 3 times a day,two weeks
15823691|NCT04254874|Drug|Abidol Hydrochloride combined with Interferon atomization|Abidol Hydrochloride:0.2g once, 3 times a day,two weeks; Interferon(PegIFN-α-2b) atomization:45ug, add to sterile water 2ml, twice a day,two weeks
15823716|NCT04254666|Behavioral|Physical Literacy & Food Literacy Intervention.|A 12-week intervention designed to expose adolescents with ID to a variety of sports and healthy eating concepts to equip them with skills and confidence to participate in physical activities and make healthy food choices. The program will follow a protocol adapted to meet the needs of a diverse group of children with ID. Sessions will be held 1 time/week for 90 minutes at a Boys & Girls Club after school; 60 minutes will focus on sport activities with 45 minutes devoted to healthy eating.
15823718|NCT04254640|Drug|Cladribine Injection|Cladribine 5 mg/m2, intravenous drip,d1-5,4 weeks per cycle.
15823719|NCT04254640|Drug|Aclarubicin|aclarubicin 10 mg, intravenous drip,d3-6,4 weeks per cycle.
15823692|NCT04254861|Procedure|Simplified Papilla Preservation Flap (SPPF) and PRGF ENDORET (PRGF ENDORET®-KMU16)|"A simplified papilla preservation flap (SPPF) will be performed. The clot phase of PRGF ENDORET (F2) will be placed in the defect, while the fibrin membrane phase (F1) will cover it.
~Blood will be extracted and collected in dedicated tubes and then centrifuged. Up to 8 tubes of 9ml will be extracted. The time from the start of the extraction to the start of the centrifugation of the tubes must not exceed 4mins.
~After centrifugation, the blood is separated into three components: Plasma rich in growth factors, White cells or leukocytes, red blood cells: this is the red column occupying the bottom of the tube.
~Following BTI's instructions, fractioning of the centrifuged blood will be performed in order to separate Fraction 2 (F2), which contains a greater number of platelets and growth factors and will be used as a clot inside the periodontal defect from Fraction 1 (F1), which will be used as a fibrin member to cover the clot. The flaps will be repositioned and sutured."
15823693|NCT04254861|Procedure|Simplified Papilla Preservation Flap (SPPF) and GTR|A simplified papilla preservation flap (SPPF) will be performed. The defect will then be treated according to the guided tissue regeneration (GTR) principle (control group). A deproteinized bovine bone mineral (DBBM) graft will be placed in the defect and covered by a collagen membrane.
15823694|NCT04254848|Other|oral stereognostic test|Six test pieces were selected from the 20 shapes of test pieces from National Institute of Dental Research. The test pieces comprises of 6 shaped forms which include circle, plus, square, rectangular, triangle and toroid shaped. A 2mm stainless steel wire was bent forming the test piece shape following the standard dimensions (13mm length and 2mm thickness)as described by National Institute of Dental Research to serve as the test pieces mould. Using the six test piece moulds, light cured acrylic resin test samples were fabricated. The test samples were trimmed and polished to meet the standardized measurements. A total of 240 test sample (6 samples for each patient) for 20 completely edentulous patients with maxillary tori and 20 completely edentulous patients without tori were made for the study. The test pieces were attached to dental floss to prevent any accidentally aspiration during the study.
15823695|NCT04254835|Drug|Cervitec F, Ivoclar Vivadent - Schaan Liechtenstein|Fluoride varnish containing Chlorhexidine and Cetylpyridinium Chloride
15823696|NCT04254835|Drug|Fluor Protector, Ivoclar Vivadent - Schaan Liechtenstein|Conventional Fluoride varnish
15823697|NCT04254822|Procedure|Transjugular intrahepatic portosystemic shunt|The TIPS procedures will be performed by experienced interventional radiologists. polytetrafluroethylene-covered stents were used with initial balloon dilatation to 8 mm, aiming for a decrease in portal-venous pressure gradient to less than 12 mm Hg.
15823698|NCT04254822|Drug|Carvedilol|Carvedilol will be started at least 5 days after the index bleeding, unless a contraindication was present. Carvedilol will be start with 6.25 mg once a day and after 3 days increase to 6.25 mg twice-daily (the maximal dose was 12.5 mg/day). Systolic arterial blood pressure should not decrease <90 mmHg.
15823699|NCT04254822|Procedure|Endoscopic variceal ligation|For endoscopic variceal ligation, the first elective session will be carried out within 7 days of randomisation. Then EBL sessions were scheduled every 10-14 days until variceal eradication (disappearance of varices or being too small to be sucked in the banding device).
15823700|NCT04254809|Behavioral|Re-Evaluating Suicidal Thoughts|Re-Evaluating Suicidal Thoughts (REST) is a is a computerized intervention designed to mitigate the experiential avoidance of suicidal thoughts. Over the course of approximately 30 minutes, individuals are provided with psychoeducation regarding the incidence rate, origin, conceptualization, and misconceptions of suicidal thoughts. Empirical evidence is presented to provide a scientific understanding of suicidal thoughts, and is aided through the use of metaphors to make concepts more accessible to viewers. REST draws from therapeutic strategies rooted in cognitive behavioral therapy (CBT) and Acceptance and Commitment Therapy (ACT) to further suggest tips for accepting (cp. approving of) the occurrence of suicidal thoughts, and introduces mindfulness and acceptance strategies for coping with them.
15823701|NCT04254809|Behavioral|Healthy Social Living|To control for potential effects of time and presentation of educational material on study outcome variables, participants randomized to the control intervention will complete a computerized psychoeducation program regarding the benefits of social support networks. Across approximately 20 minutes of audiovisual slides, participants are informed of the ways in which social connections buffer against loneliness and facilitate social learning, provided tips for expanding and maintaining their social network, and administered a brief quiz to assess for comprehension.
15823702|NCT04254796|Behavioral|Training for Awareness, Resilience, and Action (TARA)|This will be a 12-week group meditation training - Training for Awareness, Resilience, and Action (TARA)
15823703|NCT04254783|Drug|Risankizumab|Intravenous (IV) infusion
15823704|NCT04254783|Drug|Cytochrome P450 (CYP) Substrates|Tablet: Oral; CYP Substrates: midazolam, caffeine, warfarin, vitamin K, omeprazole and metoprolol
15823705|NCT04254770|Device|ADA approved Manual Toothbrush|ADA approved Manual Toothbrush
15823706|NCT04254770|Device|Marketed Power Toothbrush|Marketed Power Toothbrush
15823707|NCT04254757|Procedure|Two different treatment|One group treated by percutaneous endoscopic surgery. The another group treated by open decompression and fusion surgery
15823708|NCT04254744|Drug|Sevoflurane|Sevoflurane inhalation for anesthesia
15823710|NCT04254718|Behavioral|Digital Storytelling|Creation of a digital story about the infant with video and music selected by parents
15823711|NCT04254705|Procedure|Rectal Biopsy|Suction biopsy or forceps biopsy
15823712|NCT04254692|Drug|Liposomal bupivacaine|Participants in the intervention group will receive intraoperative injection of Liposomal bupivacaine mixed with Bupivacaine to the abdominal wall.
15823713|NCT04254692|Other|Standard of care|Participants in the standard of care group will receive intraoperative injection of bupivacaine only to the abdominal wall
15823714|NCT04254679|Drug|Opioid analgesics|"Current standard of care in the participating centers Prescription of around-the-clock non-opioid analgesics (acetaminophen and/or NSAIDs/COX-2) and a supply of opioids to be used as a rescue in case of breakthrough pain.
~The specific round-the-clock analgesia and rescue opioid regimens will be determined by the patient's primary surgeon considering the surgical procedure, comorbidities and patient's preference."
15823720|NCT04254640|Drug|G-CSF|G-CSF 300 µg,subcutaneous injection, d0-9,4 weeks per cycle.
15823721|NCT04254640|Drug|cytarabine|cytarabine 10mg/ m2, subcutaneous injectionq,q12h, d3-9,4 weeks per cycle.
15823724|NCT04254614|Device|Personalised mobile application for IBD patients|"Patients will use a mobile application for ±6months (exact period depends on interval of biologic treatment) with the following functionalities:
~Personal interactive timeline to prepare for biologic treatment with reminders for blood tests, a questionnaire to exclude contra-indications for biologic treatment (e.g. current infection) and a message from the gastroenterology nurse when blood tests results and the questionnaire have been checked. Only in case of abnormal results or answers patients will be contacted by telephone by their gastroenterology nurse, which is currently standard care.
~Information about the patients' diagnosis and biologic treatment.
~General information on e.g. IBD treatment, vaccinations, frequently used medical terms, preparing for outpatient visits, what to do in case of disease symptoms.
~Patients will fill in a questionnaire to measure study outcomes at baseline and at the end of the study period."
15823725|NCT04254601|Device|Narrow band ultraviolet B.|NBUB: DIXWELL EMLY 98 -ABRP 64 ,made in France. Red LLL, InGaAs (630 nm, 10 mW, continuous) (RIKTA, Russia)
15823726|NCT04254601|Drug|topical erythromycin cream 2% (Akne-Mycin- Egypt)|"two times per day on the entire face from the beginning to the end of the treatment period .
~The face is washed thoroughly with warm water and gentle soap, rinse well, and pat dry, patients were advised to wait 30 minutes before applying the aknemycin. To help keep new pimples from breaking out, the aknemycin was applied to the whole area usually affected by acne, not just to the pimples themselves"
15823727|NCT04254588|Other|Abdominal examination|Examination by in-person physician vs. remote physician.
15823728|NCT04254575|Other|None, observational study only (no interventions)|None, observational study only (no interventions)
15823729|NCT04254562|Behavioral|Weekly Meetings with a Supported Employment/Supported Education Specialist|Participants will receive intervention for 12 months which includes weekly meetings with a Supported Employment/Supported Education Specialist (HYPE Specialist). During the weekly meetings, the HYPE Specialist will review each participant's education and employment goals, and deliver individualized support relevant to those goals which include use of structured HYPE tools and worksheets as needed.
15823730|NCT04254562|Behavioral|Focused Skill and Strategy Training (FSST)|Participants receive a 12 week Focused Skill and Strategy Training (FSST), a structured cognitive remediation intervention.
15823731|NCT04254562|Behavioral|Enhanced Services as Usual|One hour meetings every semester to review individual academic needs and review list of available on campus resources to best meet the student's needs.
15823732|NCT04254549|Drug|Rifaximin|550 mg by mouth three times daily for 14 days
15823733|NCT04254549|Drug|Placebo|By mouth three times daily for 14 days
15823734|NCT04254523|Device|Programmed intermittent epidural bolus (PIEB) of bupicavaine|Programmed intermittent epidural boluses of bupivacaine 0,1% are administered every hour. Protocolized adjustments of the dose are performed in order to obtain adequate analgesia. Standardized patient-controlled epidural boluses are available as top-ups.
15823735|NCT04254523|Device|Continuous epidural infusion (CEI) of bupivacaine|A continuous epidural infusion of bupivacaine 0,1% is administered at a prescribed rate. Protocolized adjustments of the dose are performed in order to obtain adequate analgesia. Standardized patient-controlled epidural boluses are available as top-ups.
15823736|NCT04254523|Device|Continuous epidural infusion (CEI) of morphine|A morphine infusion (0,1mg/ml) is administered in both groups at a prescribed rate. Protocolized adjustments of the dose are performed in order to obtain adequate analgesia.
15823737|NCT04254510|Other|Myofascial relaxation technique|"Before the intervention, the number of days of the last menstrual cycle of all participants, the number of painful days throughout the cycle, pain intensity values according to the Visual Analogue Scale will be recorded, and the scores will be recorded in the participants.
~Technique of direct relaxation of fascia of both psoas muscles to the participants in the myofascial relaxation group since the end of the last cycle, 90-120 sec. It will be applied by the physiotherapist twice a week."
15823738|NCT04254497|Diagnostic Test|EGFR mutation detection kit|A microsieve membrane filter device to effectively isolate circulating tumor cells from whole blood sample has been developed by the Institute of Bioengineering and Nanotechnology. The device exploits the size difference between cancer cells and blood cells to achieve the cancer cell capture on a microsieve filter with > 85% recovery rate from 4.5-ml whole blood within 10 min, demonstrated with cancer cells spiked into whole blood samples. The device contains a densely packed pore array (> 8000 pores/mm^2) with an optimized pore diameter of 10 µm. Fluid regulation and cell counting are achieved by a simple vacuum pumping and laboratory fluorescence microscope. The captured cells are stained with anti-EpCAM-PE for CTCs, anti-CD45-FITC for white blood cells, and 4',6-diamidino-2-phenylindole (DAPI) for cell nuclei. The CTCs are identified with anti-EpCAM positive, anti-CD45 negative and DAPI positive, characterized using a fluorescence microscope.
15823739|NCT04254484|Behavioral|SIESTA Rehab Education|Staff nurses will be trained on how to improve sleep in stroke patients in the acute rehabilitation setting.
15823740|NCT04254484|Diagnostic Test|ApneaLink|Stroke patients on the SIESTA Rehab unit will be screened for sleep disordered breathing using ApneaLink monitors. Results will be interpreted by a sleep specialist who will then advise the clinical team at SRALab.
15823741|NCT04254471|Drug|AL3810|5mgQD, 7.5mgQD, 10mgQD
15823742|NCT04254471|Drug|carboplatin + etoposide|Carboplatin and etoposide are background treatment.
15823743|NCT04254471|Drug|Placebo|Placebo
15823744|NCT04254458|Diagnostic Test|Corneal densitometry|Corneal density values were measured by densitometry software of Pentacam HR-Scheimpflug corneal topography
15823745|NCT04254445|Other|Personalized training video|Using a few demographic and medical details of the patients, provided by the medical staff, the video generator will create a 2-minute personalized custom video, suitable to the age, gender, language, and medical condition of the patients. No identifying information will be used, to protect patient's privacy.
15823746|NCT04254432|Device|remote ischemic conditioning|RIC is a physical strategy performed by an electric auto-control device with cuffs placed on unilateral arms and inflated to 200 mmHg for 5-min followed by deflation for 5-min, the procedures are performed repeatedly for 5 times# two times per day. The duration of the treatment is 4 weeks.
15823772|NCT04254159|Other|Superimposed Neuromuscular Electrical Stimulation|NMES will be applied during each strengthening exercise session. A dual channel NMES stimulation device will be used with biphasic symmetric constant current impulses with a pulse width 300ms, a frequency of 50 Hz and a duty cycle of 10s on and 20s off protocol for 3 days a week for eight weeks.
15823747|NCT04254419|Biological|NK cells|"Natural killer cells will be taken from the patients peripheral blood cell collection. The administration of the cells will be done via an Ommaya intra-cavitary/intra-tumoral device.
~Once the infusion is ready for administration patients will be admitted to the infusion unit for monitoring. NK cells will be administered through the Ommaya in approximately 2 milliliters over approximately 2 minutes; followed by 1 milliliter preservative-free normal saline flush over approximately 1 minute."
15823748|NCT04254406|Other|Descriptive study|Evaluation of routine treatment
15823749|NCT04254393|Behavioral|Early Adolescent Skills for Emotions (EASE) Program|EASE has been developed to manage and reduce symptoms of depression, anxiety and distress in adolescents. EASE is designed to be delivered by non-specialists in low resource settings such as a trained school-health counsellor. The intervention comprises of 7 young adolescent group sessions, each lasting 90 minutes and involves the empirically supported components of psycho education, problem solving, stress management (slow breathing), behavioural activation, and relapse prevention and 3 caregiver group sessions, each lasting 120 minutes and involve psycho education, active listening, quality time, praise, caregiver self-care and relapse prevention.
15823750|NCT04254393|Other|Treatment As Usual (TAU)|Evidence based health practices are not available in schools to manage the mental health problems of children. No structured programs are being implemented in school settings for at-risk children. During the study, participants in TAU showing severe psychiatric symptoms that require immediate specialist treatment and follow-up, will be referred to the Institute of psychiatry (IoP)-the tertiary mental health care facility of the region.
15823751|NCT04254380|Biological|Gan & Lee Insulin Lispro Injection|Route of administration: subcutaneous injection
15823752|NCT04254380|Biological|Humalog|Route of administration: subcutaneous injection
15823753|NCT04254367|Behavioral|Learn-to-Cope|Patient education in study circles, aiming to empower patients to participate in health care and rehabilitation by increasing health literacy and sense of coherence. The study circles will meet half a day each week for eight following weeks.
15823754|NCT04254341|Other|patients with OSA|Sleep study
15823755|NCT04254328|Device|Nintendo Wii Fit|Nintendo Wii Fit group will perform including a series of yoga, balance, aerobics and muscle workout exercises by providing visual feedback on the TV screen with the Nintendo wii fit plus game console. Patients will perform these exercises in a room allocated to the thesis supervisor and together with the thesis supervisor physiotherapist. This process takes 40-50 minutes. Before starting test and after test, weight, blood pressure, pulse, respiratory rate, oxygen saturation value will be recorded. Patients will be rested if necessary during exercise.
15823756|NCT04254328|Device|Threshold IMT|Patients in the breathing exercise group will perform deep breathing exercises at home by a small breathing apparatus called as Threshold IMT. It has no unexpected side effects.Patients will do this exercise twice in a day ; morning and evening during 15 minutes. After 4-5 deep breath, patients will take normal breath till feeling relaxed.
15823757|NCT04254315|Behavioral|Group based cognitive therapy|"Patients are informed about the Optima program in the inclusion interview, and patients are participating in groups of maximum 4 persons. Each of the 5 session has a duration of 1,5 - 2 hours.
~The psychologist have developed the content of each session, with attention to thoughts and feelings regarding the current situation after a heart-condition, and the effects on life conditions. Patients get the tools to overcoming the difficulties, they experience, f.x. anxiety and stress.
~When other hospitals are joining the Optima project, the project nurse and psychologist are training the hospital staff as well as supervising."
15823758|NCT04254302|Other|WECARE web platform|The WECARE intervention allows families of children with motor difficulties to access rehabilitation therapists. The primary therapist will be an occupational therapist or a physiotherapist who will have one day a week to deliver the intervention. The therapist will act as case manager to connect families with community-based services available in their region and work, according to a transdisciplinary model, with an interdisciplinary team on a needs-based basis. Patient engagement with the therapists and in the WECARE intervention will be ensured by the collaborative coaching approach used by therapists to attain meaningful motor outcomes, as selected by the primary respondent.
15823759|NCT04254289|Behavioral|Usual Care|Usual care
15823760|NCT04254289|Behavioral|Home-based exercise program|Home-based program determined by exercise physiologist
15823761|NCT04254263|Drug|pyrotinib|pyrotinib 400 mg, orally once daily for one year
15823762|NCT04254250|Diagnostic Test|Preoperative risk estimation of disc herniation recurrence|Risk estimation of disc herniation recurrence will be evaluated preoperatively, depend on the risk significance each patient will be assigned to one of two groups - with high risk and low risk. Then each patient will undergo conventional one-level microdiscectomy.
15823763|NCT04254237|Procedure|Infraumbilical Hasson trocar incision|Infraumbilical Hasson trocar incision
15823764|NCT04254237|Procedure|Supraumbilical Hasson trocar incision|Supraumbilical Hasson trocar incision
15823765|NCT04254224|Procedure|colon resection, stoma|oral or intravenous antibiotics treatment with or without percutanous or transrectal or transvaginal drainage
15823766|NCT04254211|Other|NLR|neutrophil-lymphocyte ratio (NLR) and platelet-lymphocyte ratio (PLR)
15823767|NCT04254198|Behavioral|TERTULIAS structured dialogue peer support groups|"TERTULIAS will involve structured dialogue groups using the model developed and tested by the investigators through their preliminary research. Each group will have 10 women and will meet weekly for two hours over a 12-month period. Group meetings will be conducted in Spanish, led by a team of two FMI facilitators. Facilitation will use the structured dialogue approach. In the last two months of each cohort, participants will be invited to write their own stories or recipes, or produce poetry or art representing their experience to share with the group. These contributions will be gathered and reproduced in booklet form and each participant will receive a copy."
15823768|NCT04254198|Behavioral|Modified Attention Placebo Control (MAPC)|MAPC participants will receive a phone call every other month from the project coordinator to document that their contact information is up to date, to remind them that they are in the study and to tell them that the study is continuing. Survey data and hair samples will be gathered from them at baseline and 12 months
15823769|NCT04254185|Procedure|Simple decompression|Surgical technique
15823770|NCT04254185|Procedure|Subcutaneous anterior transposition|Surgical technique
15823771|NCT04254172|Device|Activity Monitor|Wrist and ankle sensors to be worn continuously for 2-week intervals.
15823920|NCT04253132|Drug|Placebos|oral placebo
15823773|NCT04254159|Other|Quadriceps Strengthening|Quadriceps strength training will be done with resistive elastics bands for 3 days a week for eight weeks.
15823774|NCT04254159|Behavioral|Patient Education Program|The aim of patient education is to increase awareness of patients about COPD and develop skills to better manage their disease. The patient education will be performed at least once via face to face interview. Education topics will be covered basic information about COPD, environmental risk factors, monitoring and managing the signs and symptoms of their disease, energy conservation techniques and relaxation positions to reduce dyspnea and usage of a specific inhaler.
15823775|NCT04254159|Other|Aerobic Exercise Training|Exercise training will be comprised of cardiovascular endurance training with cycle ergometer and lower extremity strength training. The exercises will be done 3 days a week at the clinic under the supervision of physiotherapist. Total duration of exercise training will last for 8 weeks
15823776|NCT04254146|Other|Aerobic exercise|Aerobic exercise will be performed to all participants for a single session. Maximum heart rate was calculated for each subject (220 - age) and a heart rate monitor (Polar FT 100, China) will be used to follow subjects' heart rate during aerobic exercise.
15823777|NCT04254133|Behavioral|Questionnaire|Complete questionnaire
15823778|NCT04254133|Procedure|Biospecimen Collection|Provide saliva samples
15823779|NCT04254133|Diagnostic Test|Genetic Testing|Undergo genetic testing
15823780|NCT04254133|Other|Genetic Counseling|Undergo counseling
15823781|NCT04254133|Other|Laboratory Biomarker Analysis|Correlative Studies
15823782|NCT04254120|Behavioral|Cognitive-behavioral therapy|Psychological treatment focusing on changing cognitions and behaviors using information processing theory and learning theory approaches.
15823783|NCT04254120|Behavioral|Integrated motivational interviewing and cognitive-behavioral therapy|Motivational interviewing is a psychological treatment approach focusing on increasing motivation by eliciting patient talk favoring behavior change and resolving patient ambivalence about change.
15823786|NCT04254094|Other|Neuropsychological scales|Basic Activity of Daily Living (BADL) and Instrumental Activities of Daily Living (IADL), Neuropsychiatric Inventory (NPI), Cornell Scale for Depression in Dementia (CSDD), Clinical Dementia Rating Scale (CDR) and defining dementia criteria. Also as part of this study, an MRI examination at baseline and at 18 months follow-up will be performed in the Bordeaux center
15823787|NCT04254081|Drug|Buprenorphine 0.15 MG|Buprenorphine 0.15mg solution will be added to a 20mL 1% buffered lidocaine solution (paracervical block) which will be administered in the paracervical space prior to osmotic dilator insertion.
15823788|NCT04254081|Drug|Lidocaine 1% Injectable Solution|20mL of 1% buffered lidocaine solution (paracervical block) will be administered in the paracervical space prior to osmotic dilator insertion.
15823789|NCT04254068|Behavioral|Parent-based prevention|Parent-based prevention is a 12 session program for parents with eating disorders and their partners. Most sessions occur on a weekly basis, most of the sessions involve both partners.
15823790|NCT04254055|Other|exercises|Those subjects included in the experimental group will receive an intervention through a program with plyometric, proprioceptive and strength exercises. The subjects included in the control group will not receive any intervention.
15823791|NCT04254042|Drug|Perindopril Arginine|10 mg Perindopril tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.
15823792|NCT04254042|Drug|Zofenopril, Calcium Salt, (1(R*),2Alpha,4Alpha)-isomer|30 mg Zofenopril tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.
15823793|NCT04254029|Dietary Supplement|MOROLSTEVER1|The intervention consisted of a daily consummation of 425 ml of drink containing the extracts of 1,38mg of leaves extracts of moringa oleifera and 23,46 mg of stevia rebaudiana Bertoni leaves extracts lasting 45 days.
15823794|NCT04254016|Dietary Supplement|HIBISTEVER1|During 8 weeks, administration of a Hibiscus-Stevia drink for 8 weeks at a dose of 4 mg / kg / day for Stevia and 4 g / day for Hibiscus. Evaluation will take place the 30th and 60th days.
15823795|NCT04254003|Device|DT1 Toric contact lenses|Delefilcon A contact lenses for the optical correction of astigmatism in people with healthy eyes with or without refractive ametropia (myopia or hyperopia)
15823796|NCT04254003|Device|AO1DfA contact lenses|Senofilcon A contact lenses for the optical correction of astigmatism in people with healthy eyes with or without refractive ametropia (myopia or hyperopia)
15823797|NCT04253990|Procedure|Precut EMR|"For treating of 10~20mm colon polyp, patient will be randomly divided into two groups, a Precut-EMR group and a EMR group.
~In Precut-EMR, endoscopist submucosally inject with saline around a polyp. Subsequently, circumferential incision/precutting was made with the tip of the snare around 2 mm outside the tumor. After that, the snare was positioned in the cut groove and tightend, and the tumor was resected using electrical current."
15823798|NCT04253990|Procedure|Conventional MER|EMR had been widely used technique. Endoscopist submucosally inject with saline around a polyp. After that, snare is positioned around a polyp, and polyp was resected using electrical current.
15823799|NCT04253977|Behavioral|HEALTH-P2|The HEALTH-P2 curriculum includes evidence based lifestyle change strategies to prevent excess gestational weight gain and postpartum weight retention embedded within and delivered as part of home visits.
15823800|NCT04253977|Behavioral|Usual Care|The Foundational (usual care) curriculum uses a strength-based, solution-focused model to provide parents with child development knowledge and parenting support, empowering parents as their child's first and most influential teacher.
15823801|NCT04253964|Drug|Pembrolizumab|ALL PARTICIPANTS: Pembrolizumab 200 mg intravenously (IV) on day 1 of each 3-week cycle for 4 cycles. Participants with predictive biomarker PD-L1 greater than or equal to 50% will not receive any other drugs besides pembrolizumab.
15823802|NCT04253964|Drug|Carboplatin|FOR PARTICIPANTS IN EITHER ARM with non-squamous OR squamous subtype, predictive biomarker PD-L1 less than 50%: Carboplatin area under the curve (AUC) 5 IV on day 1 of each 3-week cycle for 4 cycles.
15823803|NCT04253964|Drug|Paclitaxel|FOR PARTICIPANTS IN EITHER ARM with squamous subtype, predictive biomarker PD-L1 less than 50%: Paclitaxel 200 mg/m2 IV on day 1 of each 3-week cycle for 4 cycles.
15823804|NCT04253964|Drug|Nab paclitaxel|FOR PARTICIPANTS IN EITHER ARM with squamous subtype, predictive biomarker PD-L1 less than 50%: Nab-paclitaxel 100 mg/m2 on day 1, 8, 15 of 3-week cycle for 4 cycles.
15823805|NCT04253964|Other|Quality of Life Questionnaire, lung cancer-specific (QLQ-LC13)|The QLQ-C30 is composed of both multi-item scales and single-item measures. These include five functional scales, three symptom scales, a global health status / QoL scale, and six single items.
15823806|NCT04253964|Other|QLQ-C30 Global Health/Quality of Life Questionnaire|30 item questionnaire - Functional scales (physical, role, cognitive, emotional, social), symptom scales (fatigue, pain, and nausea and vomiting), global health status and quality of life scale, also several single-item symptom measures
15823807|NCT04253964|Other|COPD Assessment Test and modified Medical Research Council Dyspnea Patient Reported Outcomes|Dyspnea scale scores in patients with respiratory disease (particularly COPD) to establish baseline functional dyspnea burden (taken pre-study at Week 0 and Post Treatment at week 13)
15823808|NCT04253964|Drug|Pemetrexed|FOR PARTICIPANTS IN EITHER ARM with nonsquamous subtype, predictive biomarker PD-L1 less than 50%: Pemetrexed 500 mg/m2 IV on day 1 of each 3-week cycle for 4 cycles.
15823809|NCT04253951|Diagnostic Test|Lung Ultrasound (LUS)-monitored feeding trial|LUS-monitored (before and after) feeding trial (different consistencies might be tested in separate repeated trials according to clinical evaluation). A further LUS evaluation will be performed at a distance of 3 hours, before the next meal to check for resolution of after-meal abnormalities. All pulmonary fields will be explored according to semeiotics and previous literature.
15823810|NCT04253938|Other|Education|Subjects will be provided education about AAP approved feeding practices for infants 1 to 12 months of age.
15823811|NCT04253925|Other|Kegel exercises|global postural correction exercises
15823812|NCT04253912|Drug|VBP-245|2% Povidone-Iodine Gel
15823813|NCT04253912|Drug|Placebo Gel (no Povidone-Iodine)|Placebo Gel (no Povidone-Iodine)
15823814|NCT04253899|Procedure|Appendectomy|Interval Appendectomy
15823815|NCT04253899|Other|Observation|observation and follow up
15823816|NCT04253886|Device|Ovassapian Fibreoptic Intubating Airway|The fibreoptic bronchoscope remains one of the most important methods of intubating patients particularly when there is difficulty with intubation.Facilitating fiberoptic oropharyngeal intubation procedure, specific airways have been devised to push the tongue anteriorly to clear a passage for the fibrescope into the trachea. Of these airways Ovassapian Fibreoptic Intubating Airway (Kendall, Argyle, New York, New York, USA) and Fekry Oral Intubating Airway (Ameco Tech, Cairo, Egypt).
15823817|NCT04253873|Drug|Apatinib|Apatinib mesylate (0-14 days, 500 mg, qd), taken half an hour after a meal (the daily dose should be as much as possible), one week apart, and then given temozolomide (150mg/m2 for 5 Days); every 28 days is a cycle, medication to disease progression, intolerable toxicity, etc.
15823818|NCT04253860|Device|Transcutaneous electrical neurostimulation|Sessions of 30 minutes of TENS will be applied three times a week during 90 days
15823819|NCT04253847|Procedure|Radical antegrade modular pancreatosplenectomy|"Radical antegrade modular pancreatosplenectomy (RAMPS) includes the following aspects. Firstly, the surgical approach is antegrade, which means from the right to the left, the pancreatic neck will be transected at first and the spleen will be seperated at last. Secondly, lymph nodes dissection includes not only the regional lymph nodes(No.10,11,18 lymph nodes), but also N1 station lymph nodes (N1: 6, 8a, 8p, 12a2/b2/p2, 13a/b, 14b/c/d, 14v, 17a/b), No.7, 9 lymph nodes, the lymph nodes anterior and left of superior mesenteric artery, as well as the peripheral nerve of celiac trunk. Thirdly, the transection platform is in the pancreatic neck, which is mandatory. At last, left prerenal fascia will be resected. When the tumor abuts or infiltrates the left adrenal gland, left adrenalectomy will be performed, which is also called posterior approach RAMPS. While in normal cases, left adrenal gland will be preserved."
15823820|NCT04253847|Procedure|Standard retrograde pancreatosplenectomy|"Standard retrograde pancreatosplenectomy(SRPS) includes several aspects. Firstly, the surgical approach is retrograde, which means from the left to the right, spleen will be seperated at first and the pancreas will be transected later on. Secondly, only the regional lymph nodes will be dissected, which include No.10, No.11, No.18 lymph nodes, and No.9 lymph nodes should be dissected only when the lesion is in pancreatic neck. Thirdly, the transection platform is in the left side of the lesion, but transection at pancreatic neck is not mandatory. At last, the surgical plane is anterior to the left renal fascia, prerenal fascia will be preserved."
15823821|NCT04253834|Device|Incentive spirometer|is a device that measures how deeply a person can inhale (breathe in). It helps taking slow, deep breaths to expand and fill the lungs with air. This helps prevent lung problems, such as pneumonia. The incentive spirometer is made up of a breathing tube, an air chamber, and an indicator
15823822|NCT04253834|Device|GO2 Mouthpiece|A simple, comfortable, and straightforward silicone rubber-made, bidirectional oxygenation mouthpiece that effectively delivers PEEP with every breath
15823823|NCT04253821|Other|muscle tonus, stiffness and elasticity,six-minute walk test, Pulmonary function tests, The neck disability index|The muscle tonus, stiffness and elasticity of upper trapezius (UT), semispinalis capistis (SSC), pectoral muscles (PM) and sternocleidomastoideus muscles (SCM) were measured by using MyotonPro® device. Functional capacity was measured with six-minute walk test. Pulmonary function tests was evaluated with spirometer. The neck disability index (NDT) was applied. The forward head posture was determined by measurements of craniovertebral angle (CVA). Physical activity levels of participants were evaluated by Physical Activity Index (FIT).
15823824|NCT04253808|Behavioral|Carbohydrate-restricted, high-fat diet|"Calorie needs will be calculated as 25 - 35 kcals/kg ABW to maintain body weight before and during treatment.
~Fluid needs will be calculated as 25-35 ml/kg ABW.
~Sources of macronutrients:
~Carbohydrates: from whole grains, dairy products, legumes, fruits, and vegetables.
~Fats: from mono- and polyunsaturated fatty acids, including medium- and long-chain fatty acids.
~Proteins: plant-based proteins and lean animal-based proteins. All meals will be provided to the participants throughout the study period and the diet will be provided orally unless the patient is on a feeding tube or a feeding tube is ordered by a physician during the study period. Diet texture will be according to patients chewing and swallowing abilities. If the patient is on a feeding tube or intake is insufficient, a formula with similar macronutrient composition + a protein supplement used at the AVH will be provided."
15823825|NCT04253808|Behavioral|Usual Dietary Care|The usual diet will contain approximately 50% carbohydrates, 17% proteins, and 33% fats
15823826|NCT04253795|Other|Laryngeal mask|After the laryngeal mask will be inserted lung isolation will be achieved with an artificial pneumothorax induced during opening the pleura, which resulted to the collapse of the nondependent lung with the patient's spontaneous breathing.
15823827|NCT04253795|Other|double lumen tube|After the one lung ventilation will be started, lung isolation will be achieved by deflation of the nondependent lung.
15823828|NCT04253782|Other|Team Intervention|"The Team will meet with participants (remotely/electronically and/or by phone) and will ask that they select one of three options that may help with opioid addiction:
~treatment with buprenorphine/naloxone (BUP),
~inpatient, 12-step, or methadone regimens, or
~education only (materials provided by the CT Community for Addiction Recovery (CCAR)).
~Throughout the study, participants may switch to any other option."
15823829|NCT04253756|Device|20-gauge BD Nexiva Diffusics|The BD Nexiva Diffusics catheters are suitable for use with power injectors when a direct connection is made.
15823830|NCT04253743|Other|Nevada Healthy, Hunger-Free Kids Demonstration Benefits|SNAP households with children under age 5 incomes below 75% of the federal poverty level living in Clark County, Nevada received $40 in extra SNAP benefits per eligible child, and access to case management and nutrition education.
15823831|NCT04253730|Other|Cold Stress|60-90 mins of cooling via a liquid perfused suit circulating ~4-10°C liquid.
15823832|NCT04253717|Other|Motor control exercise program|Structure physical training aimed at strengthening muscles of the lumbo-pelvic-hip core complex in order to improve stabilization and alignment of the spine and pelvis.
15823833|NCT04253704|Combination Product|IDL lotion|IDL lotion is water-based (> 80%) with isosorbide di-(linoleate/oleate) (2.0%), caprylic/capric triglycerides (5%), glycerin (3%), glyceryl stearate (2.5%), dimethicone (2.0%), steareth-20 (1.5%), cetyl alcohol (1.0%), and butyrospermum parkii (shea) butter (1.0%).
15823834|NCT04253704|Combination Product|Control lotion|Control lotion is water-based (> 80%) with caprylic/capric triglycerides (5%), glycerin (3%), glyceryl stearate (2.5%), dimethicone (2.0%), steareth-20 (1.5%), cetyl alcohol (1.0%), and butyrospermum parkii (shea) butter (1.0%).
15823835|NCT04253691|Device|Virtual Reality Mediated Relaxation|Participants will combine the Virtual Reality technique with the Stimulus Control technique. When they go to bed at night, they will undergo the VR mediated Relaxation procedure first. If they do not fall asleep within 15-20 minutes, they get out of bed as described in the Stimulus Control Instructions. If they awake during the night, they run through the VR mediated relaxation procedure once. If they do not fall back asleep within 15-20 minutes, they should get out of bed. Their workbook will contain a handout that outlines the details. Participants will be encouraged to refer to it at home if they forget any part of the procedure.
15823836|NCT04253678|Drug|Vortioxetine|Flexible dosing from 5mg to 20mg based on attending psychiatrist's discretion
15823837|NCT04253665|Behavioral|Nursing discharge teaching|Nurses will provide multimorbid seniors inpatients with teaching related to self-management to prepare them to be discharged home. The teaching delivery will be tailored to patients' activation level and priorities. The intervention begins by determining the level of activation at which patients are and identifying priorities to address related to patients' life situation. A Discharge Teaching Guide will be used by nurses to deliver the teaching and includes six domains of self-management. For each domain, nurses first report whether a priority has been identified and what intervention they have proposed to address it. Then for each domain, teaching objectives are described and differ according to the level of patient activation. These six domains of self-management are found in the patient-oriented discharge summary, which is a document for the patient that summarizes what has been addressed in discharge teaching.
15823838|NCT04253652|Other|Fasted breath samples|Will be completed pre and post iron therapy
15823839|NCT04253652|Other|IBS-SSS|Will be completed pre and post iron therapy
15823840|NCT04253652|Other|Daily diary|Monitoring stool form, consistency and frequency on a daily basis for 4 weeks
15823841|NCT04253652|Other|Exploratory research: stool samples|Completed pre and post iron therapy for a subset of patients enrolled in the study
15823842|NCT04253639|Other|Questionnaires|"Patients must fill questionnaires to collect socio-demographics, aetiology and characteristics of pain, efficacy and tolerance regarding the TENS.
~Study sites must fill questionnaires to collect information regarding the type of pain management centre, the characteristics of the clinician, the characteristics of the TENS prescribed."
15823843|NCT04253626|Drug|Ferumoxytol Injection [Feraheme]|510mg intravenous ferumoxytol
15823844|NCT04253626|Drug|Ferrous Sulfate|325mg oral ferrous sulfate
15823845|NCT04253600|Behavioral|Risk profile screening questionnaire|Families will be asked to complete a LimeSurvey questionnaire that aims at evaluating general risk profiles associated with DLD (e.g., no elevated risk, behavioral risk, environmental risk, familial risk), as well as our exclusion criteria (e.g., hearing deficit).
15823846|NCT04253600|Procedure|Investigation of the neural correlates of DLD using Magnetic Resonance Imagery (MRI)|MRI data acquisition will take place during natural sleep in infants aged from 6 to 12 months. First, families will have to complete a security questionnaire to make sure that neither the children nor the accompanying parent have any known contraindication preventing the MRI session and that none of them is wearing any ferro-magnetic elements. Then, families will be welcomed in a calm and child-friendly environment where we will propose them some preparatory games known to facilitate sleep in children. MRI protocol will comprise structural and functional images and won't exceed 30 minutes.
15823847|NCT04253600|Behavioral|Online investigation of predictive factors associated with DLD and LANCOM app development|Parents will be asked to complete a series of online questionnaires every six months. Questionnaires will be created on LimeSurvey and will include different questionnaires, scales, and observations that aim at evaluating children's development, and especially language development, as well as parental and environmental characteristics.
15823848|NCT04253600|Behavioral|Individual behavioral and cognitive assessment|Individual cognitive and behavioral assessment will be scheduled once a year, around the child's birth date, and will comprise an extensive battery of standardized evaluation appropriate for the child's age. This individual evaluation will focus on several developmental aspects including language, psychomotor, behavioral and cognitive development, as well as executive and socio-emotional functioning, depending on the age of the children. Evaluations will be adapted to each child's specific profile, while respecting the following administration rules: (1) we will prioritize language development testing, (2) testing sessions will be adapted to each child's pace and possibilities, (3) if a child does not want to take part in the assessment, feels tired, or does not seem to be comfortable with the investigator, tests won't be administered.
15823921|NCT04253119|Drug|Antiretroviral/Anti HIV|NNRTI plus two NRTIs or PI boosted by ritonavir with 2 NRTIs per the usual standard of care of the investigator in AIDS clinics of Russia
15823849|NCT04253600|Behavioral|Automated analysis of language development and environment|"Following the individual assessment, families will be asked to record their child's language environment over a 2-days' timeframe using the LENA® device, a small wearable device allowing for large-scale all-day audio recording and automated vocal analyses of speech segments. An automatic analysis of the recordings, performed by the LENA pro software algorithms, will provide amongst others, a direct and natural measure of the child's number of vocalizations, adult word counts, conversational turns, duration of exposure to electronic media versus to meaningful language. Data acquisition will take place once a year following our sample selection, with a required recording time per day ranging from 12 to 16 hours."
15823850|NCT04253587|Device|LabyrinthVR|Head-mounted display virtual reality game designed to induce environmental enrichment in an adaptive, immersive regimen of wayfinding in novel urban and village neighborhoods.
15823851|NCT04253587|Device|Placebo Games|Commercially-available, narrative computer games marketed as cognitively enriching.
15823852|NCT04253587|Device|Coherence|Head-mounted display virtual reality game designed to present an adaptive rhythm training routine.
15823853|NCT04253574|Diagnostic Test|Imaging with 18F-FDG PET/CT and/or Ultrasound|All patients were all examined by 18F-FDG PET/CT, 176 patients additionally by US (peripheral lymph nodes (pUS) and/or abdomen (aUS)) in the search of primary tumors or metastases of their malignant melanomas.
15823854|NCT04253561|Drug|Ipatasertib|Ipatasertib will be administered orally once a day, beginning on Cycle 1, Day 1 through Day 21 of each 28-day cycle.
15823855|NCT04253561|Drug|Trastuzumab|600 mg every 3 weeks
15823856|NCT04253561|Drug|Pertuzumab|420 mg every 3 weeks
15823857|NCT04253548|Behavioral|iPeer2Peer Support Mentorship Program|iPeer2Peer is an online peer support mentorship program that has been established in multiple chronic disease populations as a self-management intervention, including chronic pain and juvenile idiopathic arthritis. The iPeer2Peer program provides modeling and reinforcement by pre-screened and trained young adult peer mentors to adolescent mentees.
15823858|NCT04253535|Other|questionnaries|Study on questionnaries
15823859|NCT04253522|Behavioral|Cognitive training|Rehabilitation program in standard ergotherapy and cognitive training with Covirtua Software and Transcranial random noise stimulation
15823860|NCT04253509|Diagnostic Test|Circulating Tumor DNA Methylation Sequencing|Whole blood (21mL) collection through venipuncture. Analysis of tumor markers and ctDNA methylation sequencing.
15823861|NCT04253496|Other|Tumor samples and MRI|We will use DNA and RNA tumor samples. We will not use germline or blood DNA. These data will be combined with their magnetic resonance imaging (MRI) at different times: at diagnosis, at the end of treatment and at the progression of the disease.
15823862|NCT04253483|Radiation|High-Dose Rate Brachytherapy|Undergo HDR
15823863|NCT04253483|Other|Quality-of-Life Assessment|Ancillary studies
15823864|NCT04253483|Other|Questionnaire Administration|Ancillary studies
15823865|NCT04253483|Procedure|Stereotactic Ablative Radiotherapy|Undergo SABR
15823866|NCT04253470|Other|embryo transfer|Step of the assisted reproduction in which embryos are placed into the uterus in order to obtain a pregnancy
15823867|NCT04253457|Drug|1ml of triamcinolone (40mg/1ml)|Single injection of 1ml of triamcinolone (40mg/1ml)
15823868|NCT04253444|Behavioral|slow deep breathing|Participants in this arm will be asked to do slow deep breathing (4 seconds inhalation and 6 seconds exhalation) for 10 minutes twice a day during the study period.
15823869|NCT04253444|Behavioral|sham breathing|Participants in this arm will be asked to do sham breathing for 10 minutes twice a day during the study period.
15823870|NCT04253431|Device|Droplet lancing device (HTL-Strefa S.A.)|
15823871|NCT04253431|Device|Microlet 2 lancing device (Bayer)|
15823872|NCT04253431|Device|OneTouch Delicia lancing device (LifeScan)|
15823873|NCT04253431|Device|ReliOn lancing device (ReliOn)|
15823874|NCT04253431|Device|Accu-Chek Softclix lancing device (Roche)|
15823875|NCT04253431|Device|BGStar lancing device (Sanofi Aventis)|
15823876|NCT04253431|Device|Ultra-Fine 33G lancets (BD)|
15823877|NCT04253431|Device|Droplet 33G lancets (HTL-Strefa S.A.)|
15823878|NCT04253431|Device|OneTouch Delicia Extra Fine 33G lancets (LifeScan)|
15823879|NCT04253431|Device|HaemoFine 33G lancets (HTL-Strefa S.A.)|
15823880|NCT04253431|Device|Softclix 28 G lancets (Roche)|
15823881|NCT04253431|Device|ReliOn Ultra-Thin Plus 33G lancets (ReliOn)|
15823882|NCT04253431|Device|GlucoJect Dual S lancing device (Menarini)|
15823883|NCT04253431|Device|Microlet 28G lancets (Bayer)|
15823884|NCT04253431|Device|BGStar Ultra-Thin 33G lancets (Sanofi Aventis)|
15823885|NCT04253418|Device|Nano-Pulse Stimulation (NPS)|Electrical pulses (nanosecond duration) applied directly to target SH lesions using sterile single-patient use treatment tips with microneedles.
15823886|NCT04253405|Device|High Flow Nasal Catheter|"HFNC will be delivered through AIRVO2. FiO2 from 21 to 100% and heated humidified gas flow up to 60 l / min with temperature of the circuit maintained at 37 degrees.
~Oxygen flow will be offered through a humidified nasal catheter. Flow and FiO2 will be titrated according to the protocol to maximize the patient´s comfort and SpO2"
15823887|NCT04253405|Device|Noninvasive positive pressure ventilation (NIPPV)|NIPPV will be performed using a facial mask (either oronasal or full face). NIPPV will deliver pressures and FiO2 according to the protocol.
15823888|NCT04253392|Device|LINX Reflux Management System|"The LINX Reflux Management System consists of a series of titanium beads each with a magnetic core connected with independent titanium wires to form an annular shape when implanted. The attractive force of the magnetic beads is designed to provide additional strength to keep a weak lower esophageal sphincter (LES) closed. During swallowing, the magnetic beads slide away from each other on the independent titanium wire links to allow esophageal distention as the bolus passes by."
15823889|NCT04253379|Diagnostic Test|Neuropsychological evaluation , Evaluation of theory of mind, Evaluation of executive functions, Evaluation of verbal skills|Several tests will be used: Raven's Advanced Progressive Matrices, auditory attention subtest of the NEPSY II, Peabody Picture Vocabulary test, specific comprehension test The cognitive TOM will be evaluated with questions about 4 stories of false beliefs. The affective TOM will be evaluated with a specific emotion inference task 4 adapted subtests from several validated scales will be used to investigate inhibition, cognitive flexibility and working memory The semantic and pragmatic competences will be evaluated with 4 comprehension tasks.
15823890|NCT04253366|Device|Clinical investigation device class IIa not marked CE|Patients should perform MammoWave exam. A short visit should be performed and during this visit a qualitative differentiation would be performed between patients with high density breast, and patients with low density breast. After the patients will be ready for the MammoWave exam. The exam will be composed of two phases: the data acquisition and the data processing. During the acquisition that should takes about 10 minutes the patients would be lying in a prone position, on a bed which is part of the MammoWave. The upper part of MammoWave has a container cup shape, which contains the breast, which also has the function of separate it from the internal parts of the device. After patient is on the bed and MammoWave would start to perform the acquisition. Once the acquisition is completed, the data will be processed through an imaging algorithm, which is integrated in the device. The final output will be composed by one or more images, plus one or more parameters describing the images.
15823891|NCT04253353|Drug|tafamidis|61 mg capsule
15823892|NCT04253353|Drug|rosuvastatin|10 mg tablet
15823893|NCT04253340|Diagnostic Test|Bone mineral analyser|high resolution digital radiology (200 µm): D0 + M12 Trabecular Bone Score:D0 + M12 DXA scan:D0 + M12
15823895|NCT04253301|Device|InnoVein Valve Treatment|Subjects will have the InnoVein Valve implanted
15823896|NCT04253288|Other|Morbidity Mortality Review (MMR)|"Standardization of Morbidity Mortality Review (MMR) in radiotherapy centers
~National database from MMR board meetings which include clinical , radiation technique and biological parameters of intrinsic radiosensitivity of patients"
15823897|NCT04253275|Genetic|blood samples|"Blood samples will be taken at inclusion, 12h, 24h, 48h, 7d, 3m and 1y for patients ; at inclusion, 3m and 1y for controls.
~Microvesicles samples will be taken at inclusion, 7d and 3M ; at inclusion and 3M for controls."
15823898|NCT04253275|Diagnostic Test|MRI without injection|MRI at inclusion for controls
15823899|NCT04253262|Drug|Rucaparib|Rucaparib (PO twice daily continuous)
15823900|NCT04253262|Drug|Copanlisib|Copanlisib (IV day 1, 8, 15; 28 day cycle)
15823901|NCT04253236|Drug|RVT-1401 680 mg/weekly|Non-randomized subjects will receive subcutaneous injection of 680 mg weekly for 12 weeks of RVT-1401
15823902|NCT04253236|Drug|RVT-1401 340 mg/weekly|Non-randomized subjects will receive subcutaneous injection of 340 mg weekly for 12 weeks of RVT-1401
15823903|NCT04253223|Biological|REMD-477|REMD-477 will be administered as a subcutaneous injection for three weekly doses
15823904|NCT04253210|Other|psychological|Participants will either view body positive images that are sexualized (vs. nonsexualized) and a great deal of evidence of photo modification (vs. low photo modification).
15823905|NCT04253197|Device|Ultrasound|Pregnant women in 3rd trimester with anterior placenta previa and lower cesarean section scar. Ultrasound was done and according to parameters of the morbidly adherent placenta, a staging system was conducted.
15823906|NCT04253184|Drug|Micra AV Transcatheter Pacing System|The Micra AV Transcatheter Pacing System (TPS) is a miniaturized single chamber pacemaker that is delivered via catheter through the femoral vein and is implanted directly inside the right ventricle of the heart to provide bipolar sensing and pacing. The Micra AV system provides a form of VDD pacing that is based on mechanical atrial sensing utilizing a 3-axis accelerometer.
15823907|NCT04253171|Device|Lithoplasty|"The lithoplasty balloon should be utilized as early as possible. If it is necessary for passage of the lithoplasty balloon, the lesion may first be predilated with an undersized conventional balloon, non-compliant or semi-compliant. If passage of the lithoplasty balloon is still not possible, it is recommended to perform rotational atherectomy with a small burr size.
~The lithoplasty balloon is sized 1:1 to reference diameter. Lithoplasty is performed with the balloon dilated at 4 atmospheres, and 10 shocks are delivered, after which the balloon is expanded to 6 atmospheres for 30 seconds, and then deflated. Up to 8 series of balloon expansion/deflation can be delivered in this manner if necessary, and several balloons may be used for long lesions."
15823908|NCT04253171|Device|Conventional|Lesion preparation is performed starting with conventional balloons, non-compliant or semi-compliant. Unless fully satisfactory dilatation is achieved with conventional balloons, it is recommended to also use modified balloons (scoring balloons, cutting balloons). If balloons cannot be passed or if dilatation is inadequate, the lesion may first be predilated with an undersized conventional, non-compliant, or semi-compliant balloon. If necessary, rotational atherectomy with a small burr size can be used to facilitate adequate balloon preparation.
15823909|NCT04253158|Behavioral|Educational standard|Behavioral intervention aimed at increasing knowledge about alcohol and other drugs.
15823910|NCT04253158|Behavioral|Educational standard and Harm prevention|Behavioral intervention aimed at increasing knowledge about alcohol and other drugs increasing intentions to use harm prevention strategies.
15823911|NCT04253158|Behavioral|Educational standard and Expectancies|Behavioral intervention aimed at increasing knowledge about alcohol and other drugs and shifting alcohol-related expectancies.
15823912|NCT04253158|Behavioral|Expectancies and Harm prevention|Behavioral intervention aimed at correcting erroneous norms about alcohol use and shifting alcohol-related expectancies.
15823913|NCT04253158|Behavioral|Educational standard and Normative perceptions|Behavioral intervention aimed at increasing knowledge about alcohol and other drugs and correcting erroneous norms about alcohol use.
15823914|NCT04253158|Behavioral|Normative perceptions and Harm prevention|Behavioral intervention aimed at correcting erroneous norms about alcohol use and increasing intentions to harm prevention strategies.
15823915|NCT04253158|Behavioral|Educational standard, Normative Perceptions, and Expectancies|Behavioral intervention aimed at increasing knowledge about alcohol and other drugs, correcting erroneous norms about alcohol use, and shifting alcohol-related expectancies.
15823916|NCT04253158|Behavioral|Normative perceptions, Expectancies, and Harm Prevention|Behavioral intervention aimed at correcting erroneous norms about alcohol use, shifting alcohol-related expectancies, and increasing intentions to use harm prevention strategies.
15823917|NCT04253145|Drug|PM 01183|Lyophilisate for solution for infusion
15823918|NCT04253145|Drug|Atezolizumab|Concentrate for solution for infusion
15823919|NCT04253132|Drug|Tolfenamic Acid|Tolfenamic acid is an NSAID closely resembling mefenamic and flufenamic acid.
15823922|NCT04253106|Genetic|Liquid biopsies (blood, gastric fluid).|Next generation sequencing of a panel of diffuse gastric cancer genes, methylation analysis. Samples collected during routine screening endoscopy.
15823923|NCT04253080|Biological|Blood sample|Blood sample before treatment, 3 months after treatment and after 1 year or relapse or resumption of disease progression.
15823924|NCT04253080|Biological|Cutaneous melanoma biopsy|Cutaneous melanoma biopsy before treatment, 3 months after treatment and relapse or resumption of disease progression.
15823925|NCT04253067|Device|Active fCO2 laser treatment|The laser probe is inserted into the vagina. Laser treatment is delivered at 6 points at each level of the vaginal wall (12, 2, 4, 6, and 10 o'clock positions). Delivery begins at the most proximal and the probe is retracted by 1 cm and another row of laser treatments are delivered. The number of levels is determined by the patient's vaginal length.
15823926|NCT04253067|Device|Sham fCO2 laser treatment|The laser probe is inserted into the vagina. The laser will remain in standby mode during the treatment preventing laser exposure. The treatment will appear to be the same as the active treatment with the probe starting at the most proximal and following the same 6 points of treatment delivery. The probe is retracted in the same manner and another row of treatment is simulated. The machine maintains a low humming noise while in standby mode. No active laser treatment is delivered.
15823927|NCT04253054|Other|Cardiovascular risk factors|Different level of cardiovascular risk factors, such as aging, hypertension, diabetes, dyslipidemia, smoke, alcohol drink, obesity and et al, associated with genetics, environments and lifestyles
15823928|NCT04253054|Other|Aging related health problems|Aging related health problems
15823929|NCT04253041|Behavioral|Effects of Instagram Exposure on Lifestyle Satisfaction|Participants will complete initial measures of sociodemographic information, the Sociocultural Attitudes Towards Appearance Scale, The Physical Appearance Comparison Scale-Revised, and baseline measures of body appreciation, body satisfaction, and mood using online Visual Analogue Scales via Qualtrics. Female undergraduate students will be randomly assigned to one of three groups. The Fitspiration and Body Positive groups will view a series of 15 Fitspiration or Body Positive images sourced from Instagram while the control group will view 15 interior design images sourced from Instagram. After viewing images, participants will complete posttest measures of body satisfaction, body appreciation, and mood using Visual Analogue scales. Thereafter, participants will be provided with four, brief short answer questions regarding their perspective on the images observed.
15823930|NCT04253028|Device|NERv's Inline Device|NERv's Inline Device attaches to existing catheters or peritoneal drains that are currently being used in the medical industry. This allows the device to measure the pH and conductance of intraperitoneal fluids that typically get drained through peritoneal drains.
15823932|NCT04253002|Behavioral|Robinson's Culturally Adapted Coping with Stress Course (A-CWS)|Participants randomized to the experimental condition will take part in the Adapted Coping with Stress Course (A-CWS). The A-CWS is a 15-session, cognitive-behavioral group intervention designed to develop and enhance African American youths' skills to adaptively cope with stress, using standard cognitive-behavioral strategies such as relaxation training and cognitive restructuring. Emphasis is given to the identification of individual and contextual factors associated with suicide risk and the unique day-to-day experiences of the youth, providing options for adaptive coping (e.g., positive thinking) that are culturally consistent. The A-CWS is structured and manualized to allow its transportability to service providers working in similar environments with similar youth.
15823933|NCT04253002|Behavioral|Standard Care Control Condition|Students meeting criteria for study inclusion and randomized into the standard care condition will be referred to the school-based health center (SBHC) mental health provider for case management. Standard care may range from (1) brief intervention by the SBHC mental health provider to (2) outside referral to local community service providers; these determinations will be made by the SBHC mental health team.
15823934|NCT04252989|Other|data collection|"Demographic data: age, sex
~Ophthalmological history: refraction of parents, previous refractions
~Ophthalmological data at each examination: intra-ocular pression, objective refraction after fog, cycloplegia with SKIACOL, slit lamp, dilated eye exam, biometrics
~Potential undesirable events (halos, photophobia...)"
15823935|NCT04252976|Behavioral|Ethical Living|Ethical principles based on Yoga philosophy, including contents of Yamas and Niyamas.
15823936|NCT04252976|Behavioral|Yoga Exercises|Ujjaii breathing and simple yoga asanas
15823937|NCT04252976|Behavioral|Mantra Meditation|Meditation with mantras
15823938|NCT04252963|Drug|MUCOLASE tablet (streptokinase • streptodornase)|streptokinase • streptodornase 5mg
15823939|NCT04252963|Drug|Placebo|Placebo of MUCOLASE tablet
15823940|NCT04252950|Behavioral|CB-SET|Community-based structured exercise therapy (CB-SET) programs for PAD have potential merit as an alternative to hospital-based SET, as they may provide similar benefit to hospital-based programs but in a convenient location for the exercise to be completed
15823941|NCT04252950|Procedure|Revascularization|Endovascular revascularization is a primary treatment option for patients with PAD
15823942|NCT04252937|Drug|Adrecizumab|HAM8101 (Adrecizumab) is a humanized IgG1 monoclonal antibody (mAb).
15823943|NCT04252924|Other|lifestyle characteristics|Exposures of interest: Mediterranean diet, orthorexia nervosa, smoking, physical activity, sleep duration, stress level
15823944|NCT04252911|Other|Bispectral index score|Bis value from two sites gives similar results
15823945|NCT04252898|Behavioral|Front-of-pack nutrition label Nutri-Score|The intervention consists of displaying the Nutri-Score on dishes and pre-packed foods.
15823946|NCT04252885|Drug|Lopinavir and Ritonavir Tablets|As indicated in arm/group descriptions
15823947|NCT04252885|Drug|Arbidol|As indicated in arm/group descriptions
15823948|NCT04252872|Drug|HCP0605|
15823949|NCT04252872|Drug|HGP1405|
15823950|NCT04252872|Drug|HCP1401|
15823951|NCT04252859|Drug|[18F]Fluoroestradiol (FES) PET/CT|[18F]Fluoroestradiol (FES) PET/CT for invasive lobular carcinoma (ILC)
15823952|NCT04252846|Drug|Perampanel|Perampanel oral tablets or oral suspension.
15823953|NCT04252833|Drug|CT-044|CT-044 HCl is a reactive species decomposition accelerant
15823954|NCT04252820|Device|WarmTouch total body blanket, Covidien Ltd, Mansfield, USA|Forced-air warming will be applied in the preanesthetic room
15823955|NCT04252807|Behavioral|Intervention arm|In addition to the routine care delivered by Lady Health Workers (LHWs), the participants in the intervention arm will receive common elements based integrated intervention. The providers of the intervention are lay health workers who will be trained in the intervention using an online course. The lay health worker will complete the online training course in a group, with interactive group activities and role plays. Lay health workers will be supported online and in-person by the trainers in monthly supervision meetings. The lay health workers will deliver intervention to distressed mothers in 15 monthly sessions. The intervention consists of three modules including 1) mothers' well-being, 2) infant nutrition,early stimulation and breastfeeding and 3) mother-infant interaction.
15823956|NCT04252807|Other|Treatment as Usual|The participants in the control arm will receive the routine visits by LHWs of their respective areas. The LHWs are trained to provide antenatal care and referral, immunization services and support to community mobilization, provision of family planning and basic curative care via door to door visits to the households of their allocated areas.
15823957|NCT04252794|Procedure|Splenic artery ligation|Splenic artery will be ligated just after takeoff from coeliac trunk at the level of body of pancreas
15823958|NCT04252794|Other|No intervention|Splenic artery is not ligated despite the presence of portal hyperperfusion
15823959|NCT04252781|Other|Exhaustive exploration|"clinical investigations
~imagery
~blood assessment
~functional respiratory investigations
~muscle function / skeletal muscle index"
15823960|NCT04252768|Drug|Eftilagimod Alpha|The chemo-immunotherapy phase consists of 6 cycles of 4 weeks each. During each cycle the subject will receive 30 mg efti subcutaneously on Day 1 and 15 in a 28-day (4-week) cycle. Efti will always be given after paclitaxel. The maintenance phase comprises 6 visits with 4 weekly intervals; during each such visit 30 mg efti is given subcutaneosuly as monotherapy.
15823961|NCT04252768|Drug|Paclitaxel|The chemo-immunotherapy phase consists of 6 cycles of 4 weeks each. During each cycle the subject will receive 80 mg/m2 paclitaxel intravenously on Day 1, 8 and 15.
15823962|NCT04252755|Behavioral|EEG Neurofeedback|Participants will undergo a baseline (pre) session, then be scheduled for 8 sessions of NFB, and finish with another session (post) after completion of all NFB sessions.
15823963|NCT04252742|Drug|Erenumab|140 mg, 2 consecutive injections of 70 mg
15823964|NCT04252742|Drug|Placebo|2 consecutive injections
15823965|NCT04252729|Procedure|Psychotherapy|Psychotherapy sessions based on Psychoanalytic Psychosomatics
15823966|NCT04252716|Device|OVD|Intraocular administration
15823967|NCT04252703|Procedure|Percutaneous coronary intervention (PCI)|Invasive cardiac catheterization, balloon angioplasty and intracoronary stenting.
15823968|NCT04252690|Device|MOBIDERM® autofit : auto-adjustable compression stocking|"The experimental protocol will require 2 visits during usual reduction phase performed at the hospital (5 days of hospitalization).
~Visit 1 will be performed the first day of hospitalization and will consist of inclusion visit and some evaluations (lymphoscintigraphy, edema volume, cutaneous characteristics).
~Between visit 1 (D1) and visit 2 (D3), patients will wear Mobiderm Autofit continually.
~Visit 2 will be performed the third day of hospitalization and will consist of evaluations (lymphoscintigraphy, edema volume, cutaneous characteristics, satisfaction survey)."
15823969|NCT04252677|Behavioral|Obesity Prevention|This intervention includes content specific to obesity behaviors-related health information, motivation, and behavioral skills.
15823970|NCT04252677|Behavioral|Health Literacy|This intervention includes content specific to improving health literacy.
15823971|NCT04252664|Drug|Remdesivir|RDV 200 mg loading dose on day 1 is given, followed by 100 mg iv once-daily maintenance doses for 9 days.
15823972|NCT04252664|Drug|Remdesivir placebo|RDV placebo 200 mg loading dose on day 1 is given, followed by 100 mg iv once-daily maintenance doses for 9 days.
15823973|NCT04252651|Other|Blood Draw|This study will involve blood draws to test for specific cytokines
15823974|NCT04252638|Behavioral|Acceptance and Commitment Therapy plus Sleep Restriction|Acceptance and Commitment Therapy (ACT) is a newer form of behavioral therapy working with acceptance, and the clarification of personal values. Acceptance, in this case, means the willingness to (temporarily) experience unpleasant sensations such as sleeplessness or tiredness without attempting to control or change them. Aims are, first, to reduce suffering due to unsuccessful control attempts (such as frustration, anger, anxiety) and second, to improve processes that are typically worsened by increased control efforts (such as sleep). Clarification of values means identifying aspects of life that are perceived as rewarding and encouraging approach-behavior in valued aspects of life (instead of avoidance-behavior that is often associated with insomnia and mental disorders).
15823975|NCT04252638|Behavioral|Cognitive Behavioral Therapy including Sleep Restriction|CBT-I, the gold standard treatment for insomnia, consists of sleep education, relaxation, sleep restriction, and cognitive therapy.
15823976|NCT04252625|Drug|Q-Urol|Q-Urol is an over-the-counter herbal supplement manufactured by Farr Laboratories. It is a combination product composed of quercetin, pollen extract, bromelain, and papain.
15823977|NCT04252625|Drug|Placebo|placebo capsule
15823978|NCT04252612|Drug|Pramlintide|SymlinPen is a 2.7 ml; 1000 mcg/ml disposable injector pen that delivers 60 or 120 mcg doses of Pramlintide.
15823979|NCT04252586|Drug|GWP42003-P|GWP42003-P presented as an oral solution containing cannabidiol in the excipients sesame oil with anhydrous ethanol, sweetener (sucralose), and strawberry flavoring
15823980|NCT04252573|Device|Chimney Endovascular Aortic Sealing (ChEVAS) System|The ChEVAS procedure involves the use of the Nellix System in conjunction with parallel branch chimney stents for the treatment of juxtarenal, pararenal, or paravisceral abdominal aortic aneurysms.
15823981|NCT04252560|Procedure|Colectomy, CRS+HIPEC|No special interventions are going to be performed. Fecal samples are going to be taken and analysed
15824014|NCT04252248|Drug|Dacogen|Intravenous (i.v.) infusion of 20 mg/m2 over 1 hour repeated daily for 5 days starting on day 1. Single repetition of cycle on day 29.
15824015|NCT04252235|Device|Air purifier|The intervention is the placement of active HEPA air purifiers in the bedroom and living room of the true air purifier arm. These air purifiers have been shown to reduce levels of particles in the home.
15824016|NCT04252235|Device|Sham air purifier|The intervention is the placement of sham HEPA air purifiers in the bedroom and living room. These purifiers look identical to real HEPA air purifiers, but do not filter the air.
15823982|NCT04252547|Other|Kangaroo Care|The preprocedural measurements (weight, heart rate, and oxygen saturation) will be recorded before the first feeding hour when they are included in the study and then they will be held on their mothers' chest for skin-to-skin kangaroo care for half an hour. Their heart rate and oxygen saturation will be recorded for half an hour. At the end of the kangaroo care, the infant will be breastfed by his/her mother. A chronometer will be started at that moment he/she begins sucking and terminated when he/she stops. The infant's heart rate and oxygen saturation will also continue to be recorded during the breastfeeding process. When the breastfeeding process is over, the infant will be allowed to rest in his/her mother's arms for two minutes and his/her physiological parameters will be recorded. Following the breastfeeding process, the infant will be weight is measured without a diaper change and his/her weight will be recorded. Then he/she will be taken back in the incubator to sleep.
15823983|NCT04252547|Other|Control|The preprocedural measurements (weight, heart rate, and oxygen saturation) will be recorded before feeding when they are included in the study and then they will be breastfed by their mothers. The chronometer will be started at that moment he/she begins sucking and terminated when he/she stops. Also, the infant's heart rate and oxygen saturation will continue to be recorded during the breastfeeding process. When the breastfeeding process is over, the infant will be allowed to rest in his/her mother's arms for two minutes and his/her physiological parameters will be recorded. Following the breastfeeding process, the infant will be weighed without a diaper change and his/her weight will be recorded. When the care process is over, it will be taken back in the incubator to sleep.
15823984|NCT04252534|Combination Product|PRP combined Magnovision|The rEMS helmet is used to stimulate the retina and visual pathways. (MagnovisionTM) combined with subtenon platelet rich plasma injection
15823985|NCT04252534|Biological|PRP|Fresh autologous platelet rich plasma, injected subtenon space.
15823986|NCT04252521|Drug|metoclopramide|10 mg Metpamid in 100 ml normal saline solution
15823987|NCT04252521|Drug|dexketoprofen trometamol|50 mg dexketoprofen trometamol in 100 ml normal saline solution
15823988|NCT04252521|Drug|metoclopramide+dexketoprofen trometamol|10 mg metoclopramide+50 mg dexketoprofen trometamol in 100 ml normal saline solution
15823989|NCT04252508|Other|Animated film|An animated film depicts the child and the caregivers in the form of avatars and retraces his journey from his room to the transfer area, then to the the operating room and finally to the post-intervention ward.
15823990|NCT04252495|Drug|Aprocitentan|A single oral dose of 25 mg.
15823991|NCT04252482|Device|CPAP|CPAP useg 3month
15823992|NCT04252469|Other|Oral care|oral care using 20mL of 0.12% CHX and gargling with 30 seconds.
15823993|NCT04252456|Procedure|Aflibercept, 5fluorouracil, Folinic Acid andIrinotecan|All patients will receive aflibercept in combination with FOLFIRI according to the Italian label
15823994|NCT04252443|Other|Evaluation of nurses' knowledge and attitudes about opioid analgesics working in a university hospital|Interventions involving nurses' pharmacological level
15823995|NCT04252430|Drug|MD1003|Single oral dose administration of MD1003 at Day 1
15823996|NCT04252417|Drug|MD1003|Single oral dose administration of MD1003 at Day 1
15823997|NCT04252391|Procedure|Perineural electrical dry needling|Standard care plus use of perineural electrical dry needling involving use of a monofilament needle of 15 or 30 mm length, 0.25 mm diameter will be placed utilizing the therapist's dominant hand following palpation of correct needle location. An electrical stimulation unit will be used to conduct an electrical impulse. The unit used will be an ES-130 by ITO (Japan) using a DC 9V battery producing an asymmetrical biphasic waveform. The unit has 6 available leads with alligator clamps, connecting to needle shafts. Parameters of PNED will include intensity set at a strong yet comfortable setting according to patient feedback. Treatment duration will be 15 minutes. Treatment frequency will be set to Medium at level 8 (80 Hz). Parameters will be set to elicit a sensory response.
15823998|NCT04252391|Procedure|Standard Care|cervical or thoracic manipulation or mobilization, muscle stretching, muscle strengthening, electrical trigger point dry needling , soft tissue release and prescribed therapeutic exercises .
15823999|NCT04252378|Procedure|Deep Serratus Anterior Plane Block|Deep Serratus Anterior Plane Block was performed just before the start of surgery after anesthetic induction through ultrasound-guidance.
15824000|NCT04252378|Procedure|Superficial Serratus Anterior Plane Block|Superficial Serratus Anterior Plane Block was performed just before the start of surgery after anesthetic induction through ultrasound-guidance.
15824001|NCT04252365|Drug|Sintilimab|Given i.v.
15824002|NCT04252365|Drug|Pembrolizumab|Given i.v.
15824003|NCT04252352|Device|Ablative fractional CO2 laser resurfacing/Radio-frequency microneedling|Intra-person split-face trial
15824004|NCT04252339|Drug|RLY-1971|RLY-1971 is an oral inhibitor of SHP2.
15824005|NCT04252326|Other|Survey|Doctors, Nurses and Dentists filled survey about adverse drug reractions
15824006|NCT04252313|Other|Music|Studies have been conducted to assess the effects of sound and noise on neonatal stress. Recently, music is being used in neonatal units to improve physiological and behavioral outcomes (Harling et al, 2009). Of the few studies done on the effectiveness of music during circumcision is a randomized double-blinded controlled trial conducted by Joyce et al (2001): it found that some physiologic outcomes were significantly lower among the music group in comparison to the EMLA group. They concluded that there is preliminary evidence to support the efficacy of EMLA and music in pain management of newborn circumcision; however, more rigorous studies are warranted for conclusive results.
15824007|NCT04252300|Drug|Rosuvastatin|Single dose of 5 mg rosuvastatin is administered as tablet orally on Day 1 of Period 1 (total length = 5 days).
15824008|NCT04252300|Drug|Rosuvastatin + BAY1817080|A single dose of 5 mg rosuvastatin tablets is administered on Day 8 of Period 2 (total length = 15 days). BAY1817080 is administered as tablets twice daily on Days 1 to 14 of Period 2.
15824011|NCT04252274|Drug|Darunavir and Cobicistat|Subjects take darunavir and cobicistat one tablet per day for 5 days, also take conventional treatments
15824012|NCT04252261|Drug|sulforaphane|To evaluate the effects of sulforaphane on the cognitive improvement of patients with frontal brain damage
15824013|NCT04252261|Drug|placedo|To evaluate the effects of sulforaphane on the cognitive improvement of patients with frontal brain damage
15824019|NCT04252209|Other|carboxy methyl cellulose|a moisturizing gel contained 3%carboxy methyl cellulose, 3% peppermint essential oil, 10% propylene glycol, 0.1% potassium sorbate, and water up to 100%.
15824020|NCT04252196|Device|usability evaluation of medical device|participants interact with medical device and rate it for usability
15824021|NCT04252170|Device|Rehabilitation Therapy, Experimental on the BrightArm Compact device|Experimental group will receive VR game-based rehabilitation therapy through Bright Cloud's proprietary device, called BrightArm Compact (BAC). An Occupational Therapist will assist as needed.
15824022|NCT04252157|Other|Kinesiotaping|Kinesiotape will be applied to the group. During the orbicularis oris muscle, I tape will be applied around the lip with a mechanical correction technique with 50-75% tension. I tape will be applied just below the Hyoid with a 50-75% tension mechanical correlation technique.
15824023|NCT04252157|Other|Plesebo Taping|An approximately 5 cm I tape will be applied to the group without applying any tension to the temporomandibular attachment for placebo taping.
15824024|NCT04252157|Other|Control|no kinesio or tape will be applied
15824025|NCT04252144|Procedure|Dietary assessment|Dietary assessment is not within standards of care for patients with gastroesophageal reflux disease in Russia. Subjects enrolled to the study are to be interviewed on most common foods consumption in terms of frequency of use and sizes of portions.
15824026|NCT04252131|Drug|cassia seed tablet|traditional Chinese herbs
15824027|NCT04252118|Biological|MSCs|3 times of MSCs(3.0*10E7 MSCs intravenously at Day 0, Day 3, Day 6).
15824028|NCT04252105|Dietary Supplement|Antioxidant|Antioxidant-rich diet (added selected types of fruits, vegetables, nuts, cereals and oils)
15824029|NCT04252092|Other|Sensory training|15 session,20 minutes sensory training program
15824030|NCT04252092|Other|Electrical stimulation|15 session,20 minutes electrical stimulation program
15824031|NCT04252079|Procedure|Endovascular Repair of Juxtarenal Aortic Aneurysm|"History taking and clinical examination.
~Preoperative Imaging
~CTA is the cross-sectional imaging modality of choice.
~Preoperative evaluation
~a-Renal evaluation
~b_ cardiac evaluation C-Pulmonary evaluation
~Surgical techniques
~Anesthesia The use of general anesthesia due to the duration of the procedures and the necessity to control patient breathing to allow precise imaging and accurate device deployment.
~Intra operative imaging A hybrid operating room with high-quality fixed imaging is needed for the performance of FEVAR.
~C-Device delivery and deployment all FEVAR procedures begin with access of the femoral arteries by either open or percutaneous technique."
15824032|NCT04252066|Drug|migalastat|This is an observational study. Patients as described in Cohort 1 should have been exposed to at least 1 dose of migalastat during pregnancy and/or breastfeeding.
15824033|NCT04252053|Other|Pilates Based Core Stabilization Training|Pilates-based core stabilization training (PBCST) is a controlled form of exercise provided improvement in stabilization of abdominal and back muscles.
15824034|NCT04252053|Other|Home based exercise|Home exercises which include pilates based core stabilization training will be structured for the people with MS according to their physical condition and will perform at home by them.
15824036|NCT04252027|Other|Sample collection|Plasma and urine sample collection
15824037|NCT04252014|Behavioral|Hookah tobacco messages|Messages communicating the risks of hookah tobacco use in 4 thematic areas: health harms, addictiveness, social use, flavorings.
15824038|NCT04252001|Device|YESS! game|"The YESS! game is a real-life game for smartphone or tablet in which the player has to solve a mystery. The adolescent plays an active role in the course of the story. This results in an interactive experience. During the game, the adolescent is challenged with regard to self-management and responsible behaviour in general life, with parallels to medical selfmanagement and responsible behaviour.
~The adolescent has to decide at several different moments whether to take action or not, whether to accept help or not and whether to share (fictive) confidential information or not. Other aspects that are covered are 'taking responsibility' and 'being on time'. The choices the adolescent makes throughout the game are registered in a coded manner, for later analysis. The game is available in Dutch, English and Spanish."
15824039|NCT04252001|Device|Snake '97|Snake '97 is a game for smartphone or tablet which is free and can be downloaded in the App Store. The game is a remake of the original snake on the mobile phone in 1997 in which the player moves the snake around and makes the snake 'consume food' (little dots) which causes the snake to grow longer. The goal is to make the snake as large as possible. The game has 12 difficulty levels.
15824040|NCT04252001|Other|Transition-toolkit|The transition toolkit consists of paper cards with assignments, ideas and tips regarding medical self-management.
15824041|NCT04251988|Device|Oculus Go VR|virtual reality headset
15824042|NCT04251975|Device|CPAP treatment|In this group of patients (CPAP group) will be prescribed CPAP treatment at an optimal pressure. It will be performed a CPAP titration with an automatic or manual CPAP according to usual clinical practice
15824043|NCT04251962|Drug|Bupivacaine|epidural solution containing bupivacaine 0.1% in normal saline
15824044|NCT04251962|Drug|Fentanyl|Epidural solution containing fentanyl 3 mcg/ml (in addition to bupivacaine) in normal saline
15824046|NCT04251936|Behavioral|Exercise training|The moderate-intense aerobic exercise training will involve supervised aerobicycle ergometer training for 30 min with 60-80% HRmax three times per week for 12 weeks.
15824047|NCT04251936|Behavioral|Smoking cessation group program|Participants of both groups will receive a 6-week standard cognitive behavioral therapy-oriented smoking cessation group program (SCP, one 60 min session per week).
15824134|NCT04251234|Other|Light intensity, ~30 lux|~30 lux compared to very dim light baseline condition <1 lux
15824048|NCT04251923|Device|Retro pubic sling|patient after hysterectomy will undergo retropubic sling surgery in the same setting. Retropubic sling will be inserted vaginally in the retropubic area following standard protocol.
15824049|NCT04251910|Drug|Sublingual film containing Dexmedetomidine|Sublingual film containing Dexmedetomidine
15824050|NCT04251910|Drug|Sublingual Placebo Film|Sublingual placebo film that matches BXCL501
15824051|NCT04251897|Device|Novel support surface|This is a magnetorheological elastomer that can dynamically redistribute the pressure over a bony prominence to be lower than the critical closing pressure while at the same time providing sufficient support.
15824052|NCT04251884|Procedure|Local anesthetic (ropivacaine)|Patients randomized in the treatment arm will receive a sonography-guided pudendal nerve block
15824053|NCT04251871|Drug|Conventional medicines (Oxygen therapy, alfa interferon via aerosol inhalation, and lopinavir/ritonavir) and Traditional Chinese Medicines (TCMs) granules|"Conventional medicines: oxygen therapy, antiviral therapy (alfa interferon via aerosol inhalation, and lopinavir/ritonavir, 400mg/100mg, p.o, bid) for 14 days.
~Traditional Chinese Medicines (TCMs) granules: 20g, p.o, bid, for 14 days."
15824054|NCT04251871|Drug|Conventional medicines (Oxygen therapy, alfa interferon via aerosol inhalation, and lopinavir/ritonavir)|Conventional medicines: oxygen therapy, antiviral therapy (alfa interferon via aerosol inhalation, and lopinavir/ritonavir, 400mg/100mg, p.o, bid) for 14 days.
15824055|NCT04251858|Procedure|Dental Scaling|The individuals will be treated by a single periodontist and the scaling and root planing procedures will be performed on all teeth as follows: local anesthetic infiltrative type of the areas to be treated, dental and root scaling using Grace 5/6 carbon steel curettes, 11/12, 13/14 and MacCall 13/14, 17/18 curettes, according to their therapeutic indications. Polishing the quadrants treated with abrasive paste; oral hygiene instructions including Bass toothbrushing, dental floss and sometimes inter-dental brush.
15824056|NCT04251858|Other|Oral hygiene instruction|Oral hygiene instructions should be given to all study participants. Guidance on the most appropriate toothbrush, toothpaste and interproximal cleaning method.
15824057|NCT04251845|Dietary Supplement|topical melatonin|Topical melatonin at 3% concentration with dosage of 15 mg once daily will be applied on the lesion for 6 weeks followed by a follow up of 3 months
15824058|NCT04251845|Other|PLACEBO|Topical application of placebo once daily for 6 weeks with a follow up for 3 months
15824059|NCT04251832|Drug|Sodium Thiosulfate|Ultrasound guided percutaneous lavage with and without Sodium Thiosulfate
15824060|NCT04251819|Drug|Placebos|Participants will receive placebo in combination with 4mg of buprenorphine to examine analgesia in acute pain tasks.
15824061|NCT04251819|Drug|Baclofen 5 MG|Participants will receive 5mg of baclofen in combination with 4mg of buprenorphine to examine analgesia in acute pain tasks.
15824062|NCT04251819|Drug|Baclofen 10mg|Participants will receive 10mg of baclofen in combination with 4mg of buprenorphine to examine analgesia in acute pain tasks.
15824063|NCT04251806|Diagnostic Test|neonatal polysomnography|This procedure will allow the detection of sleep-disordered breathing in the neonatal period.
15824064|NCT04251806|Diagnostic Test|2-year Bayley Exam|This procedure will evaluate neurodevelopmental outcomes.
15824065|NCT04251806|Diagnostic Test|2-year polysomnography|This procedure will allow the detection of sleep-disordered breathing at 2 years of age.
15824066|NCT04251793|Other|Observation|Soft tissue implant measurements and radiographs
15824067|NCT04251780|Procedure|Surgical Treatment of Hyperaldosteronism|Surgery of an Aldosterone-producing adenoma
15824068|NCT04251780|Drug|Drug treatment of Hyperaldosteronism|Treatment of Hyperaldosteronism with Spironolactone or Eplerenone.
15824069|NCT04251767|Other|washed microbiota transplantation|"Washed microbiota suspension (5u) delivered through nasogastric tube, nasojejunal tube or oral.
~Dose and frequency: 5u, once."
15824070|NCT04251767|Other|placebo|"Placebo (edible suspension of the same color as the washed microbiota suspension，5u) administered via nasogastric tube, nasojejunal tube or oral, combining with standard therapy.
~Dose and frequency: 5u, once."
15824071|NCT04251741|Diagnostic Test|Adalimumab trough concentration|In the 'drug concentration guided' group, switching to subsequent biological is based on adalimumab trough concentration
15824072|NCT04251741|Other|Usual care|In the usual care group, switch to subsequent biological is based on secondary randomisation
15824073|NCT04251728|Device|Automated mechanical peripheral stimulation|Automated mechanical pressure reaching the pain threshold in four specific points at the foots soles
15824074|NCT04251728|Other|Physical Exercise|The exercise program will be conducted for 12 weeks lasting 1 hour each session. Sessions will be held in groups and each session will comprise 4 steps: 1) Warm-up (5 min): patients will perform stretching of the main muscle groups of upper limbs, lower limbs and trunk; 2) Aerobic exercise (30 min): patients will perform continuous aerobic exercise consisting of walk on flat ground and ramps; 3) Resistance exercise training (20 min): volunteers will perform resistance exercises (2 sets x 15 repetitions) for upper and lower limbs, and trunk working the following muscle groups: shoulder flexors, extensors and abductors; elbow flexors and extensors; trunk extensors and flexors; knee flexors and extensors; and dorsiflexors and plantar flexors; 4) Cool-down (5 min): Stretching of the main muscle groups worked during the sessions and relaxation.
15824075|NCT04251728|Device|SHAM|Automated mechanical pressure reaching the sensory threshold in four specific points at the foots soles
15824076|NCT04251715|Drug|Dexamethasone|Given intraarterially via HAI pump
15824077|NCT04251715|Drug|Floxuridine|Given intraarterially via HAI pump
15824078|NCT04251715|Device|Implanted Medical Device|Implanted hepatic arterial infusion pump by surgical oncology, to deliver HAI therapy
15824079|NCT04251715|Drug|Irinotecan|Given IV
15824080|NCT04251715|Drug|Leucovorin|Given IV
15824081|NCT04251715|Drug|Oxaliplatin|Given IV
15824082|NCT04251689|Drug|Mannitol|Mannitol 20 gram plus 0.9% normal saline 100 ml one hour after cisplatin
15824083|NCT04251689|Drug|Placebo|0.9% normal saline 100 ml
15824084|NCT04251676|Other|Observational study|Observational study
15824085|NCT04251650|Other|subgingival plaque sample|for subgingival plaque sample, on three affected sites (PD>3mm) and three healthy sites (PD≤3mm), after supra-gingival plaque removal, sterile endodontic paper points were inserted in selects pockets for 30s to collect the subgingival plaque. The material was transferred into eppendorf tube, one for affected samples and one for healthy samples.
15824086|NCT04251650|Other|CGF sample|each site was sampled with a PerioPaper Strip® (Oraflow), and the volumes collected were measured with a Periotron® (Oraflow). Then samples of affected sites were stowed in an eppendorf tube with 120µL of PBS Tween. The same procedure was performed for the healthy sites
15824087|NCT04251637|Other|Cardiac output monitoring with Starling SV.|Intraoperative monitoring of cardiac output by esophageal Doppler, NICOM Starling SV and collection of values for each patient at at least 7 predefined intraoperative times.
15824088|NCT04251624|Behavioral|Goal Management Therapy|A cognitive training program aimed at improving cognitive deficits such as in memory, attention, learning, and executive functioning.
15824089|NCT04251624|Behavioral|Psychosocial Education|A group therapy program focusing on brain function, neuroplasticity, and lifestyle interventions.
15824090|NCT04251611|Other|Maintenance of physical exercise|Objectives will be established with the patient to increase the practice of physical exercise and reinforce the control of cardiovascular risk factors (CVRF) and the maintenance of a long-term cardio-healthy lifestyle.
15824091|NCT04251598|Behavioral|I Am Protecting My Child from the Sun|"The parents in the intervention group were administered the I Am Protecting My Child from the Sun program for a period of six weeks.
~Intervention groups received Sun Protection Guide for Parents, Developmental, Characteristics of 3-6 Age Group Children Brochure, Melanoma Brochure, Video, Frame, Key chain, Magnet, Puzzle, Sunscreen product, T-shirt, hat and UV testing wristband."
15824092|NCT04251598|Behavioral|SMS for sun protection|While the education+SMS group, in addition to the program, also received a total of 25 short text messages twice a week.
15824093|NCT04251585|Drug|Regular Novolin R|Intranasal insulin
15824094|NCT04251585|Drug|Placebo|Intranasal placebo (0.9% saline)
15824095|NCT04251572|Other|Blood sampling|Blood sampling
15824096|NCT04251572|Other|questionaires|Included participants will complete a baseline questionnaire at end of treatment (EOT) and a follow-up questionnaire throughout the follow-up period (Table 1). The questionnaires collect information on socio-demographics (age, gender, ethnicity, employment status, education level, housing status, incarceration, medical history and OST), injecting drug use (drugs injected, injection frequency and sharing of needle/syringe, cookers, cotton/filter or water). Details on the received DAA regime including mode of administration (direct observed therapy, pill box, etc.) and self-reported data on treatment adherence will also be recorded.
15824097|NCT04251559|Other|oral glucose loading test|oral glucose loading test was performed to all participants. gestational diabetes and control group were compared in terms of menarche age.
15824102|NCT04251520|Diagnostic Test|Pharmacogenomics testing|Participants will undergo pharmacogenomics testing and will be asked to provide a one-time buccal scraping. These results will be utilized for clinical treatment decisions.
15824103|NCT04251520|Other|Pharmacist review|Participants will have their medical information, including patient demographics, problem list, medication list, allergies, and relevant lab work reviewed by a One Point pharmacist. The pharmacist will work with the Palliative Medicine team to make medication related recommendations to improve individual patient care. The pharmacist will call the patient roughly 48 hours following their outpatient consultation or hospital discharge to review the medication list and address any medication-related questions. The pharmacy will send refill reminders to the patients.
15824104|NCT04251507|Device|Oculus Go Virtual Reality Goggles|Oculus Go is a standalone portable Virtual Reality device that enables the user to immerse in different virtual environments.Non pharmacological technique to reduce pain and anxiety during a procedure.
15824105|NCT04251494|Diagnostic Test|Carotid intima media thickness measurement (CIMT)|CIMT is a measurement of the thickness of the two inner layers of the common carotid artery wall. Using ultrasound, a linear array transducer is placed on the surface of the skin at the neck. Electrocardiogram(ECG) electrodes are placed on each wrist and one on the ankle. An image of the common carotid artery (CCA) is then produced in anterior, posterior and lateral views, and saved along with the ECG recording. The wall thickness can then be measured at the same point in the cardiac cycle using semi-automated detection software (Philips QLAB), which can reduce observer variability. The CIMT will be averaged across left and right CIMTs, as the control reference values use an average of both sides.
15824106|NCT04251494|Diagnostic Test|Pulse Wave Velocity measurement|The PWV measures the speed of a pulse wave travelling between two points in the vascular systems of known distance between them. PWV will be measured by the gold standard carotid-femoral PWV method which is a direct measurement of aortic stiffness. A 3-Lead ECG is connected alongside measurements of the blood velocity trace for the left CCA 2cm proximal to the bifurcation, and for the left common femoral artery origin.
15824107|NCT04251494|Diagnostic Test|Ankle-brachial pressure index (ABPI)|A blood pressure cuff is placed around the ankle and upper arm of the participant. A continuous wave Doppler probe is used over the surface of the skin to locate the artery distal to the cuff (such as the brachial artery in the arm, or the anterior tibial and posterior tibial arteries in the ankle). The cuff is then inflated, and the systolic pressure identified by listening cessation of the sounds produced by the probe corresponding to blood flow in the artery. The ABPI is then the ratio of the highest systolic ankle pressure divided by the highest systolic brachial pressure for the left and right sides of the body.
15824108|NCT04251494|Other|Diet questionnaire and diet diary|Dietary information will be collected in two formats. One will be a 14-item questionnaire (Martínez-González et al., 2012), which is a simplified version of a comprehensive food frequency questionnaire. This provides a quick measure of compliance to a Mediterranean dietary pattern and a rough measure of protective and adverse dietary factors that could affect individual CVD risk. The second will be a 3-day diet diary (3DDD). This will consist of participants recording the foods that they consume and the quantities, which will then be analysed for macro- and micronutrient composition once completed.
15824135|NCT04251234|Other|Baseline light intensity, <1 lux|Very dim light condition
15824136|NCT04251221|Drug|Oral Alcohol Challenge|Subjects will drink an alcohol dose designed to achieve a BAL of 0.08
15824137|NCT04251208|Other|Observational Study|No intervention will be administered.
15824109|NCT04251494|Other|Routine blood samples|Blood samples will be taken from participants during their outpatient appointment. Patients routinely have blood samples taken during this clinic. The study will use the results from the routine blood tests, and also extra blood samples to collect data on other biomarkers. The laboratory facilities at Guy's and St Thomas Hospitals will be used to conduct analysis, no other laboratories will be used. Data will be collected on Phenylalanine levels, lipids, vitamin B12 and related biomarkers.
15824110|NCT04251481|Radiation|PET/MRI with FDG|For the PET/MRI scans, an intravenous (IV) catheter (thin tube) will be used to administer dyes (contrast) for both the MRI and PET portions of the examination. The dye for the PET portion will be 18F-fluorodeoxyglucose (FDG). FDG is an FDA-approved radioactive substance (isotope) that contains chemicals that can be traced by PET/MRI. The dye for the MRI portion will be a gadolinium based contrast medium which is also an FDA-approved substance that makes certain tissues, abnormalities or disease processes more clearly visible on MRI scans. MRI uses a strong magnetic field to create images of the body. Subjects will be asked to lie on a table that will slide into the scanner; Wear earplugs to reduce the noise made by the MRI scanner and lie still throughout the time in the scanner.
15824111|NCT04251481|Radiation|MRI scan without contrast|MRI uses a strong magnetic field to create images of the body. Subjects will be asked to lie on a table that will slide into the scanner to scan the neck ; Wear earplugs to reduce the noise made by the MRI scanner and lie still throughout the time in the scanner.
15824112|NCT04251481|Radiation|MRI with gadolinium|For the MRI scans, an intravenous (IV) catheter (thin tube) will be used to administer dyes (contrast) for MR scans. The dye for the MRI will be a gadolinium based contrast medium which is also an FDA-approved substance that makes certain tissues, abnormalities or disease processes more clearly visible on MRI scans. MRI uses a strong magnetic field to create images of the body. Subjects will be asked to lie on a table that will slide into the scanner; Wear earplugs to reduce the noise made by the MRI scanner and lie still throughout the time in the scanner.
15824113|NCT04251468|Device|GEPII|Saliva probes (K+Sa) will be measured using genetically encoded potassium ion indicators (GEPIIs)
15824114|NCT04251468|Device|Ion-selective electrodes|Plasma potassium levels (K+Pl) will be measured using standard ion-selective electrodes.
15824115|NCT04251455|Procedure|Arthroscopy or discectomy with sampling of synovial fluid and synovial tissue|"Arthroscopic lysis and lavage: performed under general anaesthesia. Before initiation of arthroscopy synovial fluid was sampled with a push-and-pull method. The TMJ was investigated with an arthroscope during irrigation with sterile saline solution. Adhesions were addressed with a coblator. Synovial tissue biopsies were taken from the posterior attachment of the disc.
~Discectomy without replacement: performed under general anaesthesia. Before initiation of surgery, synovial fluid was sampled as above described. During surgery synovial tissue biopsies were taken as described above."
15824116|NCT04251442|Device|OrthoSensor Verasense Technology|IOS is used to send real time information to a monitor within the operating room that assists your surgeon in making decisions about the balance of the ligaments in your knee and the proper insertion of implants.
15824117|NCT04251429|Other|CPH-NEW Healthy Workplace Participatory Program|A participatory program for increasing effectiveness of occupational health and safety committees or peer-led employee teams through root cause analysis, prioritizing health and safety needs for effective problem-solving, identifying feasible interventions, and presenting these to senior leadership. Interventions are selected and implemented by leadership and evaluated by both teams.
15824118|NCT04251416|Drug|Sacituzumab Govitecan|Sacituzumab govitecan will be administered at 10 mg/kg weekly as an infusion for 2 consecutive weeks (2 weekly doses plus 1 week without treatment represents a single 3 week cycle). Treatment can be continued without a rest period in the absence of progression of disease or unacceptable toxicity.
15824119|NCT04251403|Diagnostic Test|Mucosal Irrigation|Following routine endoscopic evaluation, investigators will utilize the ERBEJET 2 device (ERBE USA Inc), which is commercially available for the treatment of mucosal lesions, to sample cells from the mucosal surface of the stomach. The aspirate will be collected for cytologic/pathologic assessment.
15824120|NCT04251390|Device|trexo Home|12 week intervention, with weekly contact/assessments of the affects of using the trexo Home.
15824121|NCT04251377|Device|Defensive Antiadhesive Coating DAC®, Novagenit SRL|"DAC gel, mixed with topical antibiotics is applied on the surface of the implants before implantation, in a sterile environment in the operating room.
~The topical antibiotics will be added to the reconstituted DAC® gel preparation, at the discretion of the physician, on the basis of pre-operative culture."
15824122|NCT04251364|Drug|Acetazolamide|Daily acetazolamide pill intake
15824123|NCT04251364|Drug|Atorvastatin|Daily atorvastatin pill intake
15824124|NCT04251364|Drug|Placebo oral tablet|Daily placebo pill intake
15824125|NCT04251351|Drug|Paracetamol|Paracetamol 15 mg/kg/dose IV 6 hourly for 72 hours
15824126|NCT04251351|Procedure|Mechanical antipyresis|"Mechanical antipyresis (i.e. loose clothing, tepid sponging, fanning and cooling blanket) if fever in the first 72 hours.
~If a temperature >38.5°C persists despite mechanical antipyresis, or if deemed necessary by the treating clinician, then paracetamol can be administered according to local practice (paracetamol IV 15 mg/kg as needed)."
15824127|NCT04251325|Other|Basic Life Support Courses|4 hours basic life support courses for laypersons
15824128|NCT04251312|Other|Oral Hygiene Education and Oral Hygiene Packets|Patients will be educated on oral hygiene and will be given packets containing toothpaste, mouth rinse, floss and a toothbrush
15824129|NCT04251299|Behavioral|home-based, mentored vegetable gardening program|The mentored vegetable gardening program pairs each participant with a certified Master Gardener. The participant/Master Gardener dyads work together to plan, plant and tend to a vegetable garden at the participant's home throughout the year. Gardening supplies, plants and seeds are provided.
15824130|NCT04251273|Other|This is Quitting|Text message-based intervention for quit vaping support.
15824131|NCT04251273|Other|Assessment only Control|Assessment only
15824132|NCT04251260|Other|Positioning in flexion|"The intervention group will be positioned in flexion (i.e. lower limbs in flexion, hand in midline) with an aid, the Snuggle up (Philips, USA). With positioning, the neonates bottom is tucked down in the snuggle up pocket, legs are aligned and gently flexed and hands towards midline and near the face.
~Positioning will be demonstrated to the nursing staff of the Neonatal Intensive Care Unit (NICU). The intervention group will receive positioning during day and night throughout the intervention period."
15824435|NCT04248712|Drug|Loratadine|10 mg tab once daily by mouth for 12 week duration
15824138|NCT04251195|Behavioral|Cognitive Intervention|Participants will undergo 15 minutes of a cognitively challenging activity in the Virtual Reality environment. (More details about each condition will be added after study completion to protect the blinding of our participants).
15824139|NCT04251195|Behavioral|Active Control Intervention|Participants will undergo 15 minutes of a cognitively challenging activity in the Virtual Reality environment. (More details about each condition will be added after study completion to protect the blinding of our participants).
15824140|NCT04251182|Drug|15mg T3D-959|Oral administration once daily in the morning
15824141|NCT04251182|Drug|30 mg T3D-959|Oral administration once daily in the morning
15824142|NCT04251182|Drug|45 mg T3D-959|Oral administration once daily in the morning
15824143|NCT04251182|Drug|Placebos|Oral administration once daily in the morning
15824144|NCT04251169|Drug|Pembrolizumab|Pembrolizumab 200 mg will be administered as 30 minutes IV infusion every 3 weeks beginning in Cycle 1
15824145|NCT04251169|Drug|Paclitaxel|Paclitaxel will be administered at the 80 mg/m2 dose via 1-hour IV infusion on Days 1, 8, and 15 of every 21-day cycle (beginning in Cycle 2). On days of scheduled infusions of pembrolizumab and paclitaxel (i.e., Day 1 of every cycle), paclitaxel is to be administered after infusion of pembrolizumab
15824146|NCT04251156|Drug|Semaglutide|Semaglutide administered subcutaneously (s.c., under the skin) as well as diet and physical activity counselling for 44 weeks. Doses gradually increased to 2.4 mg
15824147|NCT04251156|Drug|Placebo (semaglutide)|Semaglutide placebo administered s.c. as an adjunct to a reduced-calorie diet and increased physical activity regimen for 44 weeks
15824148|NCT04251143|Procedure|corneal cross-linking|UV-A Irradiation and riboflavin
15824149|NCT04251143|Diagnostic Test|corneal topography and tomography|Detailed Information about corneal tomography is used for diagnosis
15824150|NCT04251130|Drug|2-(2-([18F]fluoro)pyridin-4-yl)-9H-pyrrolo[2,3-b:4,5-c']dipyridine|A small molecule aimed for binding and PET-imaging of aggregated tau protein in the human brain.
15824151|NCT04251117|Biological|GNOS-PV02|GNOS-PV02 delivered by intradermal injection and electroporation
15824152|NCT04251117|Biological|INO-9012|INO-9012 delivered by intradermal injection and electroporation
15824153|NCT04251117|Drug|Pembrolizumab|Pembrolizumab administered as an intravenous (IV) infusion
15824154|NCT04251117|Device|CELLECTRA®2000 EP Device|CELLECTRA® 2000 Device is a system indicated for use to enhance the uptake and expression of plasmid-based biologics in order to enhance vaccine efficacy.
15824155|NCT04251104|Other|Images' personal relevance effectiveness in objective and subjective mood recovery|"After completing the PANAS, the negative mood induction phase (viewing a film clip) phase will begin. Before this phase, the participants will be encouraged to experience the feelings generated by the clip as intensely as possible. After viewing the film clip, participants will be asked to complete the PANAS again in order to assess the effectiveness of the negative mood induction procedure.
~Following the negative mood induction phase, the emotional recovery phase will be initiated, in which the participants will look at a total of six pictures previously selected according to their experimental condition in order to generate specific positive autobiographical memories. At the end of this phase, participants will once more complete the PANAS in order to assess the effectiveness of the emotional recovery."
15824156|NCT04251091|Other|Treadmill walking|Up to 5 bouts of 6 minutes walking on the treadmill with rest breaks allowed between sets
15824157|NCT04251091|Other|Overground Walking|Up to 5 bouts of 6 minutes walking overground with rest breaks allowed between sets
15824158|NCT04251065|Drug|Daratumumab|"Daratumumab in combination with Gemcitabine, Dexamethasone and Cisplatin (D-GDP).
~Induction phase:
~4-6 courses (according to response after cycle 4 and to patient compliance) of D-GDP every 21 days pursuant to the following schedule: Daratumumab cycle 1: 8 mg/kg i.v. on day 2 and on day 9; cycle 2-6: 16 mg/kg i.v. on day 2 and day 9) Gemcitabine 1000 mg/sm i.v. day 1 and day 8 (gemcitabine on day 8 to be skipped in case of grade 3-4 toxicity) Cisplatin 75 mg/sm i.v. day 1 Dexamethasone 40 mg i.v. or po days 1-2-3-4-9 G-CSF from day 3 to 6, and from day 10 to 13 (to be prolonged if necessary)
~Maintenance:
~starting 28 days after the beginning of cycle 4 or 6 (or, in case of toxicity grade > 1, after toxicity is resolved) and up to 24 cycles from start of D-GDP according to the following schedule: Daratumumab 16 mg/kg single administration every 28 days."
15824159|NCT04251052|Procedure|Bilateral Salpingectomy|Undergo bilateral salpingectomy
15824160|NCT04251052|Procedure|Bilateral Salpingectomy with Oophorectomy|Undergo bilateral salpingo-oophorectomy
15824161|NCT04251052|Other|Quality-of-Life Assessment|Ancillary studies
15824162|NCT04251052|Other|Questionnaire Administration|Ancillary studies
15824163|NCT04251026|Drug|DNL310|Intravenous weekly administration
15824164|NCT04251013|Device|Biliary brushing with the RX Cytology brush, Boston Scientific|"Biliary brushing during ERCP:
~Performing a dozen back and forth movements in the stenosis
~Bile aspiration if possible, by the catheter of the brush for cytological analysis
~The contents of the brush will be spread over 3 blades (numbered) then sectioned and placed in cytolit with the contents of the tubing of the brush flushed with a few cc of cytolit. Each brush in a numbered pot. Blades 1,2 and 3 +/- bile 1 joined to pot n ° 1; blades 4,5 and 6 +/- bile 2 joined to pot 2
~In the event of technical failure (impossibility of accessing the stenosis with the first or second brush, impossibility of removing the brush), the patient will be considered to have failed for this brush (absence of pathological material brought back)"
15824165|NCT04251013|Device|Biliary brushing with the Infinity® brush, US Endoscopy|"Biliary brushing during ERCP:
~Performing a dozen back and forth movements in the stenosis
~Bile aspiration if possible, by the catheter of the brush for cytological analysis
~The contents of the brush will be spread over 3 blades (numbered) then sectioned and placed in cytolit with the contents of the tubing of the brush flushed with a few cc of cytolit. Each brush in a numbered pot. Blades 1,2 and 3 +/- bile 1 joined to pot n ° 1; blades 4,5 and 6 +/- bile 2 joined to pot 2
~In the event of technical failure (impossibility of accessing the stenosis with the first or second brush, impossibility of removing the brush), the patient will be considered to have failed for this brush (absence of pathological material brought back)"
15824166|NCT04251000|Device|Joovv Mini|the smallest photomodulation device in the Joovv infrared light product line.
15824167|NCT04250987|Device|SpeediCath(R)|IC SpeediCath ® connected to pressure sensor
15824168|NCT04250974|Other|electroacupuncture|acupuncture with electricity
15824436|NCT04248712|Drug|Placebo|Contains no active ingredient
15824169|NCT04250961|Other|postoperative early shower|The shower group showered in 48-72 hours after median sternotomy with tap water.
15824170|NCT04250948|Drug|JS001|JS001, recombinant humanized anti-PD-1 monoclonal antibody for injection; 240mg ivdrip, d1, q3w.
15824171|NCT04250948|Drug|Oxaliplatin|Oxaliplatin: 130mg/m2，iv drip for 2h，d1, q3w
15824172|NCT04250948|Drug|S1|S-1: 40~60mg Bid，d1~14, q3w
15824173|NCT04250948|Drug|Capecitabine|Capecitabine: 1000mg/m2 Bid，d1-14, q3w
15824174|NCT04250935|Diagnostic Test|Patients with cognitive dysfunction|Mini Mental Test Those with a score below 21 points
15824175|NCT04250922|Drug|2-OHOA|"Subjects in Arm B will receive orally 2-OHOA during the Chemoradiation Phase.
~Subjects in Arm B will receive 2-OHOA orally during the Maintenance (Adjuvant) Phase. Patients will continue to be administered with 2-OHOA/Placebo after cycle 6 of the monotherapy phase until end of study. Adjuvant treatment will be discontinued upon determination of tumour progression as defined by RANO criteria, unacceptable toxicity, or refusal to continue study treatment."
15824176|NCT04250922|Drug|TMZ|"TMZ will be administered at 75 mg/m2, orally, once daily, continuously from Day 1 of radiotherapy to the last day of radiation for a maximum of 49 days.
~During the Maintenance (Adjuvant) Phase, all subjects will receive oral TMZ 150 - 200 mg/m2 once daily on Days 1 - 5 of each 28-day cycle for 6 cycles."
15824177|NCT04250922|Radiation|RT|During the Chemoradiation Phase, all subjects will undergo focal RT, with one treatment given daily 5 days per week over approximately 6 weeks (and no more than 7 weeks).
15824178|NCT04250909|Device|Passeo-18|POBA
15824179|NCT04250909|Device|Passeo-18 Lux|DCB
15824180|NCT04250896|Other|Control group|Standard child care in health unit plus exposure to EsIAN
15824181|NCT04250896|Behavioral|SMS´s sending by cell phone for behavior change|SMS messages sent through a cell pone through the RapidPro platform on practices related to the prevention of infant malnutrition to primary caregivers and the strengthening of counseling for the prevention of infant malnutrition with health providers.
15824182|NCT04250883|Other|Intra-abdominal pressure|8 mmHg
15824183|NCT04250883|Other|Neuromuscular blockade (NMB)|Deep NMB (PTC1-2)
15824184|NCT04250870|Diagnostic Test|Senior Fitness Test|"Chair stand test:The number of full stands performed on a seated position that can be completed within 30 seconds was recorded.
~Arm curl test: The participants were asked to lift weights starting with a full elbow extension and then full flexion.
~2-minute step test: The participant was asked to begin stepping as quickly as possible to reach the marked height for two minutes.
~Chair sit-and-reach test:The participant could extend right or left knee to a full extension, heel on the floor and ankle in a neutral position of 90 degrees. Then, the participant was asked to reach to the toes.
~Back-scratch test:The participant was asked to stand up and place his/her preferred hand over the same shoulder, palm down and fingers extended, and reach down the middle of the back as far as possible.
~8-foot up and go test:The participant was asked to get up from a chair without any arm support and walk a distance of 2.44 meters; then turn around a cone and come back to sit down on the chair."
15824185|NCT04250857|Device|HeartStart FRX|Automated External Defibrillator
15824186|NCT04250831|Dietary Supplement|agglomerated glucomannan, oligofructose and chromium mixture|Participants visited the University of Roehampton on three separate occasions: visit 1 (screening), visit 2 (baseline), and visit 3 (end of the trial) in total over a period of 4-weeks. During the 4-week study period, participants were instructed to replace breakfast and lunch with a shake (206 kcal/shake) each delivering 3g of the active ingredient (Mix: agglomerated glucomannan, oligofructose and chromium picolinate), and one snack bar each delivering 1.5g of the active ingredient (112 kcal/bar) in between breakfast and lunch, and lunch and dinner following by a selection of healthy dinner according to standard nutritional guidance not exceeding 1500 kcal/day. All subjects were instructed to prepare shakes by using a shaker or blender by mixing all ingredients with 200 ml of water. Participants were also instructed to consume all shakes and bars with an extra 200 ml glass of water throughout the study period.
15824187|NCT04250805|Drug|Lidocaine|Patients will receive Lidocaine during percutaneous gastrostomy under radiological guidance.
15824188|NCT04250805|Drug|Ropivacaine|Patients will receive Ropivacaine during percutaneous gastrostomy under radiological guidance.
15824189|NCT04250792|Drug|Naltrexone Pill|role of low dose naltrexone in patients affected with psoriasis
15824190|NCT04250779|Device|CapMedic smart inhaler device|The CapMedic device provides active coaching to promote correct and regular use of MDI.
15824191|NCT04250779|Behavioral|Video-based guidance|Patients are shown a video of how to use inhalers correctly and any questions are answered by the clinician. They are also encouraged to use inhalers regularly and correctly at home.
15824192|NCT04250766|Procedure|Echo-guided uterine biopsy|"Echo-guided uterine biopsy will be performed by a specialized radiologist by transvaginal and exclusive transuterine approach. 4 to 5 samples will be made.
~Local anesthesia will be performed. A pain assessment will be performed during the biopsy (visual or verbal scale)."
15824193|NCT04250753|Other|Walking task|30 meters walking task (15 meters round trip) following by a rest period of 2 minutes. Participants are invited to perform the 30 meters walking task twice. Inertial sensors are put on each participant foot.
15824194|NCT04250740|Other|Coffee with water|250 mL brewed black coffee with hazelnut flavouring and 50 g water
15824195|NCT04250740|Other|Coffee with butter-I|250 mL brewed black coffee with hazelnut flavouring and 50 g unsalted butter-I
15824196|NCT04250740|Other|Coffee with butter-II|250 mL brewed black coffee with hazelnut flavouring and 50 g unsalted butter-II
15824197|NCT04250727|Device|ZYN|30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.
15824198|NCT04250714|Device|Boston Scientific Cardiac Cryoablation System|cryoablation of atrial fibrillation consisting in electrical isolation of the pulmonary veins
15824199|NCT04250701|Other|Body Posture Assessment|Application of three evaluations above at a one time.
15824200|NCT04250688|Device|Ekso Training with FES|
15824201|NCT04250675|Device|Intermittent pneumatic leg compressions|Patients will be asked to use the ArtAssist® device to compress the foot and ankle (120 mmHg) of both legs for 2 hours daily for 3 months.
15824202|NCT04250675|Device|Sham|Patients will be asked to use the ArtAssist® device to compress the foot and ankle (30 mmHg) of both legs for 2 hours daily for 3 months.
15824437|NCT04248699|Dietary Supplement|Lumenato|tomato oleoresin obtained from yellow dry tomato pulp
15824207|NCT04250649|Procedure|subcutaneous tissue disinfection|"Skin and subcutaneous incision (up to the muscular fascia) with superficial blade scalpel, disinfection of the subcutaneous tissue with 3cc of Betadine solution, placement of the retractors, dissection and development of the delto-pectoral interval with deep blade scalpel.
~When the joint is opened, bacteriological smears are taken from 5 sites in the two groups. 1) exposed subcutaneous tissue, 2) surgeon's gloves (distal end of fingers), 3) superficial blade, 4) deep blade, 5) retractors.
~The rest of the shoulder surgery procedure does not differ from what is commonly performed.
~The samples are sent to bacteriology for bacterial culture. Anaerobic research is done specifically for P. acnes. The results are considered negative after 10 days."
15824208|NCT04250636|Drug|3BNC117-LS|Intravenous infusion of 3BNC117-LS at 30mg/kg
15824209|NCT04250636|Drug|10-1074-LS|Intravenous infusion of 10-1074-LS at 30mg/kg
15824210|NCT04250623|Other|Health care product (gel)|hyaluronic acid intimate moisturizing gel (to be applied on the subject's skin)
15824211|NCT04250610|Other|Survey|On-line survey.
15824212|NCT04250597|Drug|GNX102|Dose Escalation
15824213|NCT04250584|Device|iSlpr™|mandibular advancement device
15824214|NCT04250584|Device|SomnoDent® Classic|mandibular advancement device
15824215|NCT04250571|Other|"information about No treatment group"|Participants will receive no pills and will be told that they are in the no treatment group
15824216|NCT04250571|Other|imaginary pill technique|Participants will be instructed to take an imagined pill. This instruction consists of a procedure including five steps (i.e., identifying the IP sensitive problem, building trust/belief/reality of the IP, constructing a personally meaningful IP, taking the IP, suggestions for self-administering the IP in real life, and building adherence). Participants in this group receive daily e-mail reminders.
15824217|NCT04250571|Other|open label placebo|"Participants will have the information that they are receiving inert pills (i.e. P-Dragees, containing Placebo), combined with the following scientific rationale: (a) deceptive as well as open label placebos have been found to be effective in relieving symptoms in a variety of clinical conditions namely anxiety, depression, chronic pain (the placebo effect is powerful), (b) classical conditioning are one of the possible mechanism of this effect (the body automatically responds), (c) positive expectations may help but are not necessary, (suspend disbelief), (d) compliance with these instructions are important for outcome (taking the pills faithfully is important).
~Participants in this group receive daily e-mail reminders."
15824218|NCT04250558|Procedure|Lower Extremity Amputation|patients 18 years of age or older who will have a planned lower leg (either below knee, through knee, or above knee) amputation surgery are scheduled to undergo a lower extremity amputation (either below knee, through knee or above knee), performed by a participating surgeon or delegate. Provision of informed consent.
15824219|NCT04250545|Drug|Sapanisertib|Given PO
15824220|NCT04250545|Drug|Telaglenastat Hydrochloride|Given PO
15824221|NCT04250532|Other|Drowning|Measurement of pulse oximetry, after lifeguard immersion during their morning training
15824222|NCT04250519|Drug|Sodium Hypochlorite|Sodium hypochlorite is used as intracanal irrigant to minimize the post operative pain
15824223|NCT04250506|Drug|Daridorexant|Daridorexant (ACT-541468) administered as film-coated tablets for oral use.
15824224|NCT04250506|Drug|Placebo|Placebo administered as tablets for oral use.
15824225|NCT04250506|Drug|Moxifloxacin|Moxifloxacin administered as film-coated tablets for oral use.
15824226|NCT04250493|Biological|Homeostasis Model Assessment of insulin resistance (HOMA)|Fasting blood sample for : glucose, insulinemia, hemoglobin and lipid test to determine the Homeostasis Model Assessment of insulin resistance (HOMA) index
15824227|NCT04250493|Behavioral|MOntreal Cognitive Assessment (MoCA)|Cognitive evaluation with MOntreal Cognitive Assessment (MoCA)
15824228|NCT04250493|Behavioral|Clinical characteristics of AMS patients|Severity and progression of motor disorders assessed by the UMSARS scale, severity of dysautonomia assessed by the COMPASS31 scale ; quality of life questionnaire (AMS-Qol) for the level of difficulty experienced by the patient (on activities such as : move; walk; maintain balance; talk; feed)
15824229|NCT04250493|Procedure|Brain Magnetic Resonance Imaging (MRI)|Brain Magnetic Resonance Imaging (MRI) : putamen imaging, bridge and cerebellum; white substance hypersignals volume
15824230|NCT04250493|Biological|Blood sampling|Optional blood sampling for the constitution of a biological collection
15824231|NCT04250480|Dietary Supplement|beta-alanine|beta-alanine tablet
15824232|NCT04250480|Dietary Supplement|placebo|rice powder tablet
15824233|NCT04250454|Behavioral|CONTRACT|"The intervention will consist of four elements:
~Personal meeting - detailed information to the parents before the age of 15 weeks CA (1-3 days)
~Home Activity Plan (HAP)
~Home-based Feedback training
~Electrical muscle stimulation
~Combination of these elements has been chosen in order to ensure that optimal muscle growth is achieved through multi-modal stimulation of the motor and cognitive development of the child."
15824234|NCT04250441|Device|Focused Transcranial Ultrasound|The FDA has determined that power intensity limits of 720 mW/cm squared at 2 megaHertz is safe for clinical use; the proposed equipment works within these parameters. Furthermore, monitoring sessions up to one hour as proposed in this study are routinely used in patients even with acute brain injury at 2 megaHertz without any reports of complications induced by the ultrasound device. No brain heating, cavitation or bleeding has been identified with the proposed equipment and protocol. For each individual safety can be followed by performing a selective mental status exam at each session completion.
15824235|NCT04250428|Behavioral|Demand intervention|"Women in the demand intervention arm will receive a home visit by a study nurse who will highlight the importance of supplementation and prophyllaxis to women. During this session, women will also be informed regarding side effects and the ideal timing of supplementation (after meals)."
15824236|NCT04250428|Behavioral|Supply intervention|In order to directly test the importance of access barriers, we will deliver supplements as well as malaria chemo- prophyllaxis directly to women through home visits by study nurses.
15824237|NCT04250415|Procedure|Surgery|
15824238|NCT04250402|Procedure|Resection|Radical resection.
15824239|NCT04250389|Other|Hemodynamic assessment (micro and macrocirculatory)|"Each of the variable related to macro- and microcirculatory will be evaluated before and one hour after start of MB infusion.
~Macrocirculatory parameters will include :
~Mean, systolic, diastolic arterial, heart rate (HR)
~Cardiac output (CO), sequential vascular response (SVR) and stroke volume (obtained with transthoracic echocardiography or transpulmonary thermodilution catheter if available).
~A passive leg raising (PLR) test will be performed before and one hour after MB infusion. Patients will be classified as fluid responder if they had a CO of at least 10% after PLR.
~Microcirculatory parameters will include :
~Cutaneous and gingival refill time
~Tissue oxygen saturation combined with vascular occlusion test (VOT)
~Video microscopy measurements of the sublingual microcirculation
~Metabolic variables: Arterial blood gases including arterial lactate and central venous blood gases."
15824240|NCT04250376|Device|Focused Transcranial Ultrasound|The FDA has determined the power intensity limits that are safe for clinical use; the proposed equipment works within these parameters. Furthermore, monitoring sessions up to one hour as proposed in this study are routinely used in patients even with acute brain injury at 2 megaHertz without any reports of complications induced by the ultrasound device. No brain heating, cavitation or bleeding has been identified with the proposed equipment and protocol. For each individual safety can be followed by performing a selective mental status exam at each session completion (for example for hippocampal targets, there will be a delayed recall memory test).
15824241|NCT04250363|Drug|M5717|Participants will receive single ascending oral dose of M5717 powder in capsule on Day 1 (early liver stage) or on Day 4 (late liver stage).
15824242|NCT04250363|Biological|PfSPZ Challenge|Participants will receive 3200 units of Plasmodium falciparum sporozoites by DVI.
15824243|NCT04250363|Drug|Placebo|Participants will receive placebo matched to M5717 on Day 1 (early liver stage) or on Day 4 (late liver stage).
15824244|NCT04250350|Biological|Lebrikizumab|Subcutaneous injection
15824248|NCT04250324|Biological|BZ019|A treatment program will include lymphodepleting chemotherapy with fludarabine and cyclophosphamide (flu/cy) followed by single-dose of BZ019 administered intravenously (IV).
15824249|NCT04250311|Drug|MMH-407|MMH-407: For oral use.
15824250|NCT04250311|Drug|Placebo|Placebo: For oral use.
15824251|NCT04250298|Dietary Supplement|sucrosomal iron|oral intake of iron as sachets or capsules
15824252|NCT04250285|Other|descriptive method|After obtaining relevant permissions from the university and organization of education and selecting participants, the study was explained for students and their satisfaction obtained. Then questionnaires were given to participants. To observe ethical considerations, questionnaires were anonymous and has been confided that the participants' responses was maintained in the study and is not given anyone
15824253|NCT04250272|Procedure|Thoracoscopic lobectomy|Thoracoscopic lobectomy was performed for lung cancer
15824254|NCT04250259|Dietary Supplement|Placebo|2 tablets of placebo in the morning before breakfast and one tablet of placebo in the evening before dinner for 24 months
15824255|NCT04250259|Dietary Supplement|SAMe 400 mg tablet|SAMe supplement (SAMe 400 mg tablet), 2 tablets in the morning before breakfast and one tablet in the evening before dinner (a total dose of 1,200 mg daily) for 24 months
15824256|NCT04250246|Drug|Ipilimumab plus nivolumab plus guadecitabine|"Cohort A Melanoma ARM A Guadecitabine: 30-45 mg/m2 s.c./day 1-5 q21 x 4 cycles and from W13 q28 x 6 cycles Ipilimumab: 3 mg/Kg i.v. plus nivolumab 1 mg/Kg i.v. on W1, 4, 7 and 10 and from W14 nivolumab 480 mg i.v. q4 wks for 2 years
~Cohort B NSCLC ARM A Guadecitabine: 30-45 mg/m2 s.c./day 1-5 q21 x 4 cycles and from W13 q28 x 6 cycles Ipilimumab: 1 mg/Kg i.v.q 6wks plus nivolumab 3 mg/Kg i.v. q2 wks until W13, then ipilimumab: 1 mg/Kg i.v. q 6wks plus nivolumab 480mg i.v. q4wks for 2 years"
15824257|NCT04250246|Drug|Ipilimumab plus nivolumab|"Cohort A Melanoma ARM B Ipilimumab: 3 mg/Kg i.v. plus nivolumab 1 mg/Kg i.v. on W1, 4, 7 and 10 and from W14 nivolumab 480 mg i.v. q4 wks for 2 years
~Cohort B NSCLC ARM B Ipilimumab: 1 mg/Kg i.v. q 6wks plus nivolumab 3 mg/Kg i.v. q2 wks until W13, then ipilimumab: 1 mg/Kg i.v. q6 wks plus nivolumab 480mg i.v. q4wks for 2 years."
15824259|NCT04250220|Diagnostic Test|e-Health based strategy: PPG-based screening using a smartphone and ECG patch|PPG-analysis via Smartphone-App (Preventicus Heart Beats) and ECG patch
15824260|NCT04250207|Drug|K-321 Solution|K-321 solution drops
15824261|NCT04250207|Drug|Placebo Solution|Placebo solution drops for K-321
15825343|NCT04241471|Device|traditional incision and drainage (I&D)|traditional incision and drainage (I&D)
15824262|NCT04250194|Device|CT-Guided Biopsy|Images will be generated by a CT scanner to accurately insert a needle into the lung nodule allowing a sample to be removed for testing
15824263|NCT04250194|Device|Navigation bronchoscopy|A virtual three-dimensional map of the lung will be generated enabling the physician to perform an anatomically precise biopsy
15824264|NCT04250181|Other|RF ablation of atrial fibrillation|Comparison of standard, 40W and 50W RF energy setting for ablation of atrial fibrillation
15824265|NCT04250155|Drug|XmAb24306|Participants will receive intravenous (IV) XmAb24306.
15824266|NCT04250155|Drug|Atezolizumab|Participants will receive IV XmAb24306 followed by IV atezolizumab
15824267|NCT04250155|Drug|XmAb24306|Participants will receive IV XmAb24306 followed by IV atezolizumab.
15824268|NCT04250142|Device|Self-etching Adhesive|A Self-etching adhesive will be used to cover deep carious dentin after a selective removal of caries lesion to soft dentin procedure.
15824269|NCT04250142|Device|Glass Ionomer|A conventional glass ionomer will be used to cover deep carious dentin after a selective removal of caries lesion to soft dentin procedure.
15824270|NCT04250116|Drug|NOAC monotherapy|Patients enrolled in the anticoagulation mono therapy arm would be administered with apixaban 5 mg twice daily or rivaroxaban 20 mg once daily for 2 years after randomization. In case of renal impairment, reduced dose of apixaban (2.5 mg twice daily) or rivaroxaban (15 mg once daily) or Warfarin would be considered.
15824271|NCT04250116|Drug|Dual therapy with apixaban and clopidogrel|Patients enrolled in the dual antithrombotic therapy arm would be administered with apixaban 5 mg twice daily or rivaroxaban 15 mg once daily and clopidogrel 75 mg daily for 2 years after randomization. In case of renal impairment, reduced dose of apixaban (2.5 mg twice daily) or rivaroxaban (10 mg once daily) or Warfarin would be considered.
15824272|NCT04250077|Behavioral|Community Reinforcement And Family Training (CRAFT)|"Community Reinforcement Approach and Family Training (CRAFT) is a scientifically based intervention designed to help concerned significant others (CSOs) to engage treatment-refusing substance abusers into treatment. This new intervention method was developed with the belief that the CSO can play a powerful role in helping to engage the substance user in treatment. It is often the substance user who reports that family pressure or influence is the reason sought treatment. CSOs benefit by becoming more independent and reducing their depression, anxiety and anger symptoms even if their loved one does not enter treatment.
~CRAFT uses a positive approach versus confrontation, emphasizing learning new skills to cope with old problems. Some components include: how to stay safe, outlining the context in which substance abusing behavior occurs, teaching CSOs how to use positive reinforcers (rewards) and how to let the substance user suffer the natural consequences for their using behavior."
15824273|NCT04250077|Behavioral|We The Village Peer Community Forum|An online peer support forum with other CSOs. Members of the forum post questions or comments to weekly peer-led discussions and receive responses and feedback from other CSO forum members. Members typically express concerns regarding their IP's wellbeing and ask other members to share any strategies they have employed when dealing with their IPs. Interactions typically, are based either in 12-Step strategies members have learned (usually through Al-Anon or Nar-Anon Family Groups or Family Training Workshops provided by treatment programs) or in CRAFT skills learned (usually from treatment programs or other We The Village members). A staff member from We The Village monitors forum interactions to ensure members are interacting respectfully.
15824274|NCT04250064|Drug|Bevacizumab Injection|Additional concurrent low-dose Bevacizumab with standard EBRT
15824275|NCT04250064|Radiation|Ultra-low-dose RT|Ultra-low-dose EBRT instead of standard dose RT
15824276|NCT04250051|Drug|Cytarabine|Given IV
15824277|NCT04250051|Biological|Filgrastim|Given SC
15824278|NCT04250051|Drug|Fludarabine|Given IV
15824279|NCT04250051|Drug|Fludarabine Phosphate|Given IV
15824280|NCT04250051|Drug|Ivosidenib|Given PO
15824281|NCT04250025|Procedure|60 patients benefit from immediate venous angioplasty stenting plus medical treatment, i.e. elastic compression and anticoagulation|60 patients benefit from immediate venous angioplasty stenting plus medical treatment, i.e. elastic compression and anticoagulation
15824282|NCT04250012|Behavioral|Internet-based ACT intervention|The Internet-based ACT intervention included a 10-week web-based program consisting of five modules with different themes that the participants were instructed to process during the course of two weeks. The program was based on the processes of ACT and included themes such as life values, mindfulness, defusion, self-as-context acceptance and self-compassion. The content of each module consisted of text, video, exercises with audio files, and homework assignments. In addition, the participants filled in a diary with exercises in paper format. The intervention included also three remote meetings (à 45 minutes) via a videoconferencing tool doxy.me conducted by a psychologist. The remote meetings took place at the beginning, after 4 weeks, and at the end of the intervention.
15824283|NCT04250012|Behavioral|Psychoeducation|The psychoeducation group received a self-help booklet and a link to a web-based wellness training program. The program included exercises with MP3 audio files. No personal support during the 10-week intervention was provided.
15824284|NCT04249999|Behavioral|ActivOnline|Access to online physical activity platform (www.activonline.com.au)
15824285|NCT04249986|Behavioral|The Borg Rating of Perceived Exertion|Participants who satisfy the exclusion criteria and health assessment instrument are categorized in the lowest risk group for cardiac events and does not require medical screening for mild to moderate exercise per ACSM guidelines.
15824286|NCT04249973|Other|Collection of urine and feces|Urine and feces are collected at the families home. A short questionnaire is filled in by the parents
15824287|NCT04249960|Behavioral|Managed transition|Young people, their family and clinicians will receive transition guidelines and will be asked to follow them as much as possible.
15824288|NCT04249947|Biological|P-PSMA-101 CAR-T cells|P-PSMA-101 is an autologous chimeric antigen receptor (CAR) T-cell therapy designed to target prostate cancer cells expressing the cell surface antigen prostate-specific membrane antigen (PSMA).
15824289|NCT04249947|Drug|Rimiducid|Rimiducid (safety switch activator) may be administered as indicated
15824290|NCT04249934|Dietary Supplement|Caffeinated Coffee|A single 8 ounce cup of regular starbucks coffee will be given to the participant in the am post operative day two. Participants will have 15 minutes to consume the coffee. Additionally, medical record data will be collected up to 30 days after surgery.
15825344|NCT04241458|Drug|BI 703621|BI 703621
15825345|NCT04241458|Drug|Placebo|Placebo
15824291|NCT04249934|Dietary Supplement|DecaffeinatedCoffee|A single 8 ounce cup of decaffeinated starbucks coffee will be given to the participant in the am post operative day two. Participants will have 15 minutes to consume the coffee. Additionally, medical record data will be collected up to 30 days after surgery.
15824292|NCT04249908|Drug|Besifovir Dipivoxil Maleate|Besifovir 150 mg q.d.
15824293|NCT04249882|Drug|Placebo|Matched to active medication
15824294|NCT04249882|Drug|Naltrexone|50 mg once a day
15824295|NCT04249882|Drug|Varenicline|1 mg twice a day
15824296|NCT04249869|Drug|VGH-AD1|VGH-AD1 includes Yi-gan-san 3.0g, Huan-shao-dan 1.0g, Danshen(Radix et Rhizoma Salviae Miltiorrhizae) 0.75g, Tian-ma(Rhizoma Gastrodiae) 0.75g, Gou-teng(Ramulus Uncariae Cum Uneis) 0.375g, and Ba-ji-tian(Radix Morindae Officinalis) 0.375g, two times per day, each serving a small packet of 7.5 grams of concentrated granules.
15824297|NCT04249856|Diagnostic Test|Dynamic Spectral Imaging (DYSIS)|Women who have a colposcopy exam performed at Randers Regional Hospital were examined by Dynamic Spectral Imaging colposcopy (DYSIS)
15824298|NCT04249843|Drug|BGB-3245|Administered as specified in the treatment arm
15824299|NCT04249830|Biological|Allogeneic Stem Cell Transplant|The allogeneic stem cell transplant involves transferring the stem cells from a healthy person (donor) to the participant via infusion.
15824300|NCT04249830|Device|CliniMACS TCR α/β Reagent Kit and CliniMACS CD19|The CliniMACS™system can be used to selectively enrich or reduce specific cell populations based on the magnetic cell selection (MACS) technology developed by Miltenyi Biotec. Cell mixtures can be separated in a magnetic field using one or more immunomagnetic- labeled antibodies specific for the cell types of interest (e.g.TCR αβ+ T cells and CD19+ B cells from HPC(A) products).
15824301|NCT04249817|Other|Video Conferencing with Exteneded Role Practitioner (VC-ERP)|Participant goes to Ontario Telemedicine site for follow-up. At site, participant will get a physical assessment by an extended role practitioner and then will connect to their rheumatologist by videoconferencing for completion of follow-up.
15824302|NCT04249804|Drug|Magnesium Sulfate 1000 MG|intrathecal versus IV infusion of Magnesium sulfate for prevention of postspinal shivering
15824303|NCT04249791|Procedure|Transplantation of the uterus from live donor.|Laparoscopic-robotic hysterectomy for uterine transplantation in live-donor patient.
15824304|NCT04249778|Drug|Dapagliflozin|Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Participants will receive dapagliflozin 10 mg once daily
15824305|NCT04249778|Drug|Placebo|Participants will receive placebo tablet once daily
15824306|NCT04249765|Other|Assessing grasping force, pinch force,|"Grip Strength The participants sat upright on a chair with their feet supported. The tested arm was positioned on a table with the shoulders slightly abducted and neutrally rotated, the elbow in 90° of flexion, the forearm in 0° between pronation and supination, and the wrist in neutral resting position. The participants were instructed to maintain that position during the test. The grip strength of both hands was measured using the Hand Dynamometer.
~3. Pinch Strength Participants were seated at a table on which the dynamometers were positioned. The subjects were told to keep their elbow flexed without resting their arm or the grip handle of the dynamometer on the table."
15824307|NCT04249739|Drug|Pembrolizumab|Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Keytruda ™ (pembrolizumab) has recently been approved in the United Stated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
15824308|NCT04249726|Procedure|Direct composite resin restoration|A direct composite resin restoration will be provided intracoronally without cuspal coverage.
15824309|NCT04249726|Procedure|Direct composite resin restoration followed by full coverage metal ceramic crown|A direct composite resin restoration will be provided intracoronally followed by a full cuspal coverage metal ceramic crown.
15824310|NCT04249713|Drug|Brodalumab|Interleukin 17 Receptor A Antagonist
15824311|NCT04249700|Device|Curve Sauna Dome|All participants receive WBH for 80-110 minutes in an infrared sauna. Participants lay supine in the sauna during this time, and their head is external to the sauna.
15824312|NCT04249687|Biological|botulinum toxin|neuromodulator
15824313|NCT04249687|Biological|Placebo|placebo
15824314|NCT04249674|Diagnostic Test|Dextrometorphan|Administration of 4 ml=10 mg of Dextrometorphan (Bexine sirup)
15824315|NCT04249674|Genetic|Genotyping by single nulcetoide polymorphism.|Single nucleotide polymorphism determination
15824316|NCT04249635|Dietary Supplement|DHA|Women received supplementation of Based on Schizochytrium oil, 100% DHA (DSM) from 14 weeks of pregnancy until delivery.
15824317|NCT04249622|Other|Best Practice|Given standard of care pertuzumab-based chemotherapy
15824318|NCT04249622|Other|Questionnaire Administration|Ancillary studies
15824319|NCT04249622|Drug|Rifaximin|Given PO
15824320|NCT04249609|Other|HCHO meals and exercise|Exercise will be conducted after high carbohydrate dinner and prior to high carbohydrate breakfast
15824321|NCT04249609|Other|LCHO meals and exercise|Exercise will be conducted after high fat dinner and prior to high fat breakfast
15824323|NCT04249583|Biological|botulinum toxin|neuromodulator to be injected in the GL region
15824324|NCT04249583|Biological|Placebo|Placebo to be injected in the GL area
15824325|NCT04249570|Other|Povidone iodine|
15824639|NCT04247074|Biological|botulinum toxin neuromodulator|QM1114-DP will be injected into either the LCL, GL, or both the LCL and GL
15824326|NCT04249557|Behavioral|exercise is medicine|a 12-week exercise classes program combined with other motivational skills, including feedback and information technology support. The whole program lasts for 1 year for each participant
15824327|NCT04249544|Drug|Pramipexole|1mg of pramipexole
15824328|NCT04249544|Drug|Placebo|1mg equivalent of placebo
15824329|NCT04249531|Drug|Amikacin Inhalation Dry Powder|Patient will inhale the weeks after iv amikacin, dry powder amikacin per inhalation once 400 mg, next week once 700 mg and the last week 1000 mg
15824330|NCT04249531|Drug|Amikacin Injectable Product|patient wil receive one dose of 400 mg amikacine intravenously in week 1
15824331|NCT04249518|Behavioral|Videoeducation|No drugs used. The only difference in the to arms is the way the extradition is.
15824332|NCT04249505|Device|"2WIN Photoscreener"|"non-cycloplegia refraction by Adaptica 2WIN"
15824333|NCT04249505|Device|"Plusoptix A12"|"non-cycloplegic refraction by Plusoptix A12 photoscreener"
15824334|NCT04249505|Device|"Retinomax"|"non-cycloplegic refraction by Retinomax K+ auto refractor"
15824335|NCT04249492|Device|IOL implantation experimental (Isopure 1.2.3.)|Implantation of trifocal IOL POD F GF consisting of light distribution order: far > intermediate > near
15824336|NCT04249492|Device|IOL implantation active comparator (Micropure 1.2.3.)|Implantation of trifocal IOL POD F GF consisting of light distribution order: far > near > intermediate
15824337|NCT04249479|Other|CM Temperature (20° C)|CM will be administered at 20° C (room temperature).
15824338|NCT04249479|Other|CM Temperature (37° C)|CM will be administered at 37° C (pre-heated).
15824339|NCT04249479|Other|Weight|The patients' weight is measured prior to scanning by a technician on a weighing scale available in the scanner room.
15824340|NCT04249466|Other|Questionnaire|"During this consult, several parameters will be measured :
~nutritional and physical activity parameters: Food Frequency Questionnaire (FFQ), International Physical Activity Questionnaire (IPAQ), Three-Factor Eating Questionnaire (TFEQ-R18), impedance test, anthropometric measurements, resting energy expenditure
~demographic and clinical parameters : Family history, date of birth (month and year), sex, genotype, best forced expiratory volume (FEV) (over the 12 months preceding inclusion), bacterial colonization
~patient treatment and biologic parameters: corticosteroid therapy (with dosage, over the 12 months preceding inclusion), antidiabetic treatment (oral or insulin), IV antibiotic treatment, corrective treatments, pancreatic enzymes, OGTT (blood glucose and insulin levels at three times), lipid balance, vitamin dosage."
15824341|NCT04249440|Procedure|Preoperative systemic treatment|neoadjuvant chemotherapy combined with trastuzumab as preoperative systemic treatment
15824342|NCT04249427|Drug|Erenumab Prefilled Syringe|140mg Erenumab, pre-filled syringe given by subcutaneous injection
15824343|NCT04249427|Other|Placebo|Placebo, pre-filled syringe given by subcutaneous injection
15824344|NCT04249414|Device|PulmoVista 500|"Monitoring of Ventilation and Perfusion with the PulmoVista 500 during clinical routine.
~No medical interventions required"
15824349|NCT04249388|Other|No Intervention, just observation|No Intervention, just observation
15824350|NCT04249362|Drug|Durvalumab|All patients will receive 1500 mg durvalumab via IV infusion q4w for up to a maximum of 12 months.
15824351|NCT04249349|Device|Assisted gait with a motorized ankle foot orthosis|The motorized ankle foot orthosis is a powered lower extremity assistance device with an actuated ankle joint. A novel control software has been design and implemented in this device, which allows precise joint movement and recording of data from training session.
15824352|NCT04249336|Drug|Fluoro-Calcium-Phospho-Silicate based dentifrices|Bio-Active glass based formulation
15824353|NCT04249336|Drug|8% Arginine based dentifrices|Tubular occluding formulation
15824354|NCT04249336|Drug|8% Strontium Acetate|Tubular occluding formulation
15824355|NCT04249336|Drug|Sodium Fluoride|No claim of relieving Dentin Hypersensitivity
15824356|NCT04249323|Drug|CORT113176 Lipid Capsule Formulation|CORT113176 Lipid Capsule Formulation 10-200 mg for oral administration
15824357|NCT04249323|Drug|Placebo matching CORT113176 Lipid Capsule Formulation|Placebo matching CORT113176 Lipid Capsule Formulation 10-200 mg for oral administration
15824358|NCT04249323|Drug|Prednisone|Prednisone standard release tablets 1 x 20 mg plus 1 x 5 mg for oral administration
15824359|NCT04249310|Drug|Tiotropium/Olodaterol|Soft Mist Inhaler product
15824360|NCT04249310|Drug|Tiotropium|Soft Mist Inhaler product
15824361|NCT04249297|Drug|Duphaston® (Dydrogesteron)|No intervention. Description of routine practice only. Prescribed Duphaston® according local marketing authorization and international and Russian In-Vitro Fertilization guidelines for luteal phase support as part of an Assisted Reproductive Technology (1 tablet 3 times a day starting at the day of oocyte retrieval).
15824362|NCT04249284|Drug|BMS-986165|Specified dose on specified days
15824363|NCT04249284|Drug|BMS-986165 prototype 1|Specified dose on specified days
15824364|NCT04249284|Drug|BMS-986165 prototype 2|Specified dose on specified days
15824365|NCT04249271|Other|serum sampling|repeated serum sampling during pregnancy and thereafter
15824366|NCT04249258|Drug|Dobutamine|Dobutamine will then be administered at doses of 5mcg/kg/min, 10mcg/kg/min, 15mcg/kg/min and 20mcg/kg/min.
15824367|NCT04249245|Other|Nasal Swab|All
15824368|NCT04249232|Drug|Abaloparatide 80 micrograms per Pen dose|prefilled injector pen to deliver 80 micrograms daily subcutaneously
15824369|NCT04249232|Drug|Placebo prefilled injector pen|prefilled injector pen to deliver inactive solution daily subcutaneously
15824370|NCT04249219|Other|Viewing e-cigarette ads|All participants will see the same e-cigarette ads presented in a random order.
15824371|NCT04249206|Procedure|Root Canal Treatment|
15824372|NCT04249193|Other|Transfusion|pRBC and non-pRBC transfusions
15824373|NCT04249167|Drug|Atezolizumab|Given IV
15824374|NCT04249167|Procedure|Cryosurgery|Undergo cryoablation of the primary tumor
15824375|NCT04249167|Drug|Nab-paclitaxel|Given IV
15824376|NCT04249154|Drug|Eligard|Eligard dose of 22.5mg given, 50Gy in 20 treatments of radiation therapy to start 12 weeks after first injection concurrent with second injection of Eligard
15824377|NCT04249141|Behavioral|Survey and concept mapping|ICU providers who participoated in SCCM ICU Liberation Collaborative will be invited to participate in surveys and a concept mapping excercise
15824378|NCT04249128|Dietary Supplement|Vegetarian Collagen|Collagen is a protein made up of amino-acids, which are in turn built of carbon, oxygen and hydrogen.
15824379|NCT04249128|Dietary Supplement|Keratin|Keratin (/ˈkɛrətɪn/) is one of a family of fibrous structural proteins known as scleroproteins. α-Keratin is a type of keratin found in vertebrates. It is the key structural material making up hair, nails, feathers, horns, claws, hooves, calluses, and the outer layer of skin among vertebrates.
15824380|NCT04249128|Dietary Supplement|Ceramides|Ceramides are a family of waxy lipid molecules. A ceramide is composed of sphingosine and a fatty acid. Ceramides are found in high concentrations within the cell membrane of eukaryotic cells, since they are component lipids that make up sphingomyelin, one of the major lipids in the lipid bilayer.
15824381|NCT04249128|Dietary Supplement|Astaxanthin|is a naturally-occurring carotenoid found in algae, shrimp, lobster, crab and salmon.
15824382|NCT04249115|Device|Nano-Pulse Stimulation (NPS)|Electrical pulses (nanosecond duration) applied directly to target SK lesions using sterile single-patient use treatment tips with microneedles.
15824383|NCT04249102|Device|Guardian Connect, Medtronic|Guardian Connect is real-time continuous glucose sensor systems which provide glucose information updated every 5 minutes
15824384|NCT04249102|Device|Abbott Diabetes Care|Abbott Diabetes Care is a Flash Glucose Monitoring system that provides up to 8 hours of retrospective continuous glucose monitoring data to users when the monitor is waved in proximity with the sensor.
15824385|NCT04249089|Behavioral|Relaxation video and pamplet|This group will be asked to watch a video and perform relaxation techniques twice a day following surgery
15824388|NCT04249063|Drug|Xylocaine 1 % and Normal Saline|3cc aliquots of local anaesthetic will be injected into the right and left cornual regions and centrally in the fundus. This will be achieved by using a flexible hysteroscopic needle.
15824389|NCT04249063|Drug|Normal Saline|3cc aliquots of normal saline will be injected into the right and left cornual regions and centrally in the fundus. This will be achieved by using a flexible hysteroscopic needle.
15824390|NCT04249050|Dietary Supplement|Oral Impact powder|Oral nutritional supplement containing fish oil, arginine and RNA
15824391|NCT04249037|Drug|bictegravir/emtricitabine/tenofovir alafenamide (BIC/F/TAF)|A 30 day supply of Bictegravir 50mg/Emtricitabine 200mg/Tenofovir Alafenamide 25mg will be provided to the rapid start arm.
15824392|NCT04249037|Drug|Standard initiation of antiretroviral therapy (ART)|Standard initiation of ART at the discretion of provider + new diagnosis package with laboratory evaluations and social work referral.
15824393|NCT04249024|Device|Laser treatment|The participants in the laser group are treated with a 970 nm diode laser and if calculus is present scaling and root planning (SRP). The peri-implant pocket will be radiated with the 970 nm laser, removing bacteria, diseased epithelium and granulation tissue. The laser will be used at a maximum of 20s intervals before water irrigation. Laser settings continuous wave mode and power between 1.0-1.3W. Total treatment time will vary with the depth of the pocket and size of the surrounding bone crater.
15824394|NCT04249024|Procedure|Mucosal flap surgery|The participants will receive a conventional peri-implant mucosal flap surgery of affected implants, and return after 7-10 days for suture removal. The surgery is a well-established treatment of peri-implantitis.
15824395|NCT04249024|Behavioral|Oral hygiene instructions|Oral hygiene instructions of how to clean around dental implants as per individual needs in terms of access to clean and fine motor skills.
15824396|NCT04248998|Dietary Supplement|Fasting-mimicking diet|Cyclic, 5-day, calorie-restricted (600 KCal on day 1; 300 KCal on days 2-5), low-carbohydrate, low protein diet every three weeks
15824397|NCT04248998|Drug|Metformin|Metformin 850 mg twice a day
15824398|NCT04248998|Drug|Preoperative chemotherapy|"Chemotherapy will consist of:
~four triweekly cycles of doxorubicin 60 mg/mq plus cyclophosphamide 600 mg/mq, followed by
~twelve consecutive cycles of weekly paclitaxel 80 mg/mq"
15824399|NCT04248985|Other|Pre-Imaging - an ultrasound technique of acquiring images|Technique involves finding low quality images of the heart during CPR prior to pausing CPR to acquire high quality images once CPR is paused.
15824400|NCT04248972|Device|PBM|A whole body red light therapy (NovoTHOR®) will be carried out during 20 minutes
15824401|NCT04248972|Other|PLACEBO PBM|A placebo whole body red light will be carried out during 20 minutes
15824402|NCT04248959|Behavioral|Multimodal prehabilitation|"Physical Prehabilitation:
~Combination facility-/home-based exercise consisting of aerobic exercise (4-5 days/week (d/wk)), resistance exercise (2-3 d/wk), and daily mindfulness practice.
~Aerobic exercise
~Facility-based, high-intensity interval training (HIIT), 2 d/wk, 35 min/session, 4-min work and 3-min recovery period; cycle ergometer or arm ergometer (for those who cannot weight-bear) at 75% to 95% of baseline VO2peak
~Home-based, moderate-intensity continuous training (MICT), 2-3 d/wk, >=30 min/session, brisk walking (or equivalent) aiming to achieve a target HR of 40-70% of maximal HR
~Resistance exercise
~Home-based, moderate-intensity resistance training, 2-3 d/wk, all major muscle groups (working around tumour-related deficits), 8-10 exercises, 12-15 repetitions, resistance bands and body weight based
~Psychological Prehabilitation:
~Daily mindfulness practice, 20 min/session, and guided by audio file created at Mount Sinai Hospital"
15824403|NCT04248946|Other|Transcranial direct current stimulation|tDCS alters neural excitability in a polarity-specific manner via a weak direct electric current delivered through electrodes placed on the scalp. There are 3 types of stimulation: anodal, cathodal, and sham. In anodal tDCS, the positive electrode is placed over the target brain area to increase neuronal excitability. In cathodal tDCS, the negative electrode is placed over the target brain area to decrease neuronal excitability. Sham tDCS emulates the physical sensations of active (anodal/cathodal) tDCS but current is only delivered for a short period of time and is not enough to cause any neuromodulations
15824638|NCT04247087|Drug|placebo solution|1 vial of placebo solution (solution for injection in the venous line of the extracorporeal hemodialysis circuit) post hemodialysis 3 times a week for 12 months
15824404|NCT04248933|Behavioral|Peer-Delivered Behavioral Activation (Peer Activate)|The Peer Activate intervention will consist of weekly one-hour BA sessions led by a PRC for a period of twelve weeks. In these sessions, participants will receive individualized support in learning skills to assist in their retention and persistence in methadone treatment and will be guided through exercises aimed at incorporating substance-free, rewarding activities into their daily life. Participants will have the option to attend weekly one-hour group sessions led by a PRC to reinforce the skills learned in individual sessions.
15824405|NCT04248920|Behavioral|Clinic to Community Education Program|The C2C program aims to improve participants' knowledge of epilepsy and access to services and to provide support. Participants randomized to the intervention group will complete the C2C program. They will receive an in-person one-on-one 60-minute education session and will be introduced to, and encouraged to participate in, the programs and support services that are provided by Epilepsy Southwestern Ontario (ESWO).
15824406|NCT04248907|Other|0 pound tension|A digital fish scale will be attached to the distal strap of a gel liner to measure the distraction values while casting. A digital fish scale can measure in pounds or kilograms depending on how you set it. The digital fish scale will be held in place while casting to maintain a consistent tension between the scale and the residual limb.
15824407|NCT04248907|Other|2 pound tension|A digital fish scale will be attached to the distal strap of a gel liner to measure the distraction values while casting. A digital fish scale can measure in pounds or kilograms depending on how you set it. The digital fish scale will be held in place while casting to maintain a consistent tension between the scale and the residual limb.
15824408|NCT04248907|Other|4 pound tension|A digital fish scale will be attached to the distal strap of a gel liner to measure the distraction values while casting. A digital fish scale can measure in pounds or kilograms depending on how you set it. The digital fish scale will be held in place while casting to maintain a consistent tension between the scale and the residual limb.
15824409|NCT04248894|Other|Exercise training of High Intensity|High intensity
15824410|NCT04248894|Other|Exercise training of Moderate Intensity|Moderate intensity
15824411|NCT04248894|Other|Untraining|Sedentary
15824412|NCT04248881|Behavioral|Healthy Lifestyle Education|"Healthy lifestyle information (education) is distributed to participants during the World Cancer Day Walk via brochure, lectures, and professional counseling."
15824413|NCT04248868|Device|The Bashir™ Endovascular Catheter|The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.
15824414|NCT04248868|Drug|r-tPA|Pulse spray and infusion
15824415|NCT04248855|Drug|KAN-101|Intravenous (IV) infusion
15824416|NCT04248855|Drug|Placebo|Intravenous (IV) infusion
15824417|NCT04248842|Device|Continuous monitoring system|Patients recruited will be continuously monitored with Isansys Lifetouch patch, Isansys wireless blood pressure monitor (Meditech Blue BP-05), Nonin WristOx 3150 as well as departments standard monitors
15824422|NCT04248816|Behavioral|Usual care|Subjects will receive outreach through their providers as is standard of care.
15824423|NCT04248816|Behavioral|Opt-out|Research staff will send a letter to patients encouraging them to get a surveillance ultrasound and include an order slip for them to get it done at a health system facility.
15824424|NCT04248816|Behavioral|Opt-out + Incentive|Research staff will send a letter to patients encouraging them to get a surveillance ultrasound and include an order slip plus an unconditional $20 incentive for them to get it done at a health system facility.
15824425|NCT04248803|Other|GLUMA (Kulzer GmbH, Germany) desensitizing agent|GLUMA desensitizer is used to reduce tooth sensitivity
15824426|NCT04248790|Behavioral|mobile app to improve adherence to PrEP self-management|Access to the mobile app which includes the sex and PrEP diary, information on HIV/STI testing, PrEP reminders and geo-location features.
15824427|NCT04248777|Other|standardised OCT-guided intervention|The first OCT run (run1) analyse plaque characteristics, identify proximal and distal landing zones (according to previously published criteria) , measure lesion length and reference segments dimensions (diameters and luminal areas). The second run (run2) aims to assess adequate guidewire recrossing point into stent jailed side branch and identify early stent mechanical non-optimal results. The third run (run3) analyse final stent expansion and identify major struts malposition and edge dissection.
15824428|NCT04248764|Other|Foam roller application|Following the fatigue protocol, foam roller application will be applied to the quadriceps femoris muscle for five minutes in the prone position.
15824429|NCT04248764|Other|Massage application|Following the fatigue protocol, sports massage will be applied to the quadriceps femoris muscle for five minutes.
15824430|NCT04248751|Device|Regeneten|A new scaffold material made of highly purified, type I collagen from bovine tendons has shown great promise as a bioinductive implant that helps induce the formation of new tendon-like tissue over the surface of partial- or full-thickness rotator cuff tears. This new graft material has the benefit of decreasing surgery time, as it takes a few minutes to put in place, while increasing healing and tendon thickness.
15824431|NCT04248751|Procedure|Debridement|The bursa will be debrided thoroughly, and rotator cuff edges will be shaved down to stable tissue. The rotator cuff will be repaired using multiple single row triple loaded suture anchor placed adjacent to the articular margin
15824432|NCT04248738|Behavioral|NEEDS|NEEDS intervention includes assessing patients' social needs and resources (SocNSuppR) and communicating those SocNSuppR to discharge teams
15824433|NCT04248725|Behavioral|E-TIPS|Chronic pain self-management strategies for employed individuals with physical disabilities
15824434|NCT04248712|Drug|Famotidine|40 mg tab twice daily by mouth for 12 week duration
15824438|NCT04248686|Behavioral|CoED Online Intervention|Online, guided self-help ED intervention that offers cognitive behavioral therapy (CBT) based tools to improve ED symptoms, while also teaching the healthy methods of behavioral WL, for individuals with clinical/sub-clinical binge-type EDs with comorbid overweight/obesity
15824441|NCT04248660|Other|uterine artery doppler measurement|"The effect of delivery type on changes in uterine blood flow will be investigated.
~Doppler results groups will be defined according to the effect of deviations in uterine blood flow on neonatal and perinatal results."
15824442|NCT04248647|Behavioral|Multimodal prehabilitation|"This arm will receive a 4-week prehabilitation program consisting of:
~Exercise: Participants will receive a 3x/week aerobic and strength training exercise program. They will perform 2 workouts per week at home and attend an in-hospital supervised exercise session once per week.
~Nutritional counselling: Participants will meet with a registered dietician who will provide personalized nutritional recommendations and a whey protein supplement, tailored according to participants' self-reported dietary intake and anthropometric measurements.
~Psychological support: Participants will receive a 90-minute session at baseline, and weekly in-hospital follow-ups throughout the preoperative period. The sessions will aim to reduce preoperative distress and improve adherence to the exercise program and nutritional recommendations. Psychological support will be delivered by a trained master's student, under the direct supervision of a registered Clinical Psychologist."
15824443|NCT04248634|Procedure|Delayed colo-anal anastomosis|"Colo-anal anastomosis performed in two surgical steps:
~- Step one: the colon is exteriorized transanally and 5 cm of the colon is left outside without anastomosis creation.
~Step two: after 7 days, the excess colon is resected and the colo-anal anastomosis is created."
15824444|NCT04248621|Drug|Leuprorelin|LHRH agonist
15824445|NCT04248621|Drug|Goserelin|LHRH agonist
15824446|NCT04248621|Drug|Triptorelin|LHRH agonist
15824447|NCT04248621|Drug|Degarelix|LHRH antagonist
15824448|NCT04248621|Drug|Bicalutamide|Antiandrogen
15824449|NCT04248621|Drug|Flutamide|Antiandrogen
15824450|NCT04248621|Drug|Maximum androgen blockade|Combination therapy with LHRH agonist and antiandrogen
15824451|NCT04248608|Procedure|serratus plane block|ultrasound guided block
15824452|NCT04248608|Procedure|erector spinae block|ultrasound guided block
15824453|NCT04248608|Drug|Morphine Sulfate|intravenous morphine sulfate 0.1 mg/kg
15824454|NCT04248595|Drug|Homoharringtonine|De novo AML or relapsed AML patients recieve chemotherapy regimen contained homoharringtonie and azacitidine.
15824455|NCT04248595|Drug|Azacitidine|De novo AML or relapsed AML patients recieve chemotherapy regimen contained homoharringtonie and azacitidine.
15824456|NCT04248582|Device|Cryotherapy|LNSC will be performed with low-pressure liquid nitrogen (<5 psi) at 25 watts using a cryotherapy catheter passed through the working channel of the endoscope.We will plan to administer LNSC as follows: up to three cycles of 20 to 40 seconds each directed at the bulkiest aspect of the tumor. During each cycle, a surface area of approximately 2 to 3 cm2 is targeted. Up to three sites are treated during each session. Tissue thawing is verified between cycles by waiting at least 60 seconds before re-treatment, and by observing a return to baseline color of the tissue and complete disappearance of ice crystals after reperfusion. After the procedure is completed, patients will be monitored in the recovery unit for at least 30 minutes. Patients will be discharged after monitoring if they meet the endoscopy unit's standard discharge criteria.
15824457|NCT04248569|Drug|DNAJB1-PRKACA peptide vaccine|"Patient 1-3: DNAJB1-PRKACA peptide vaccine will be administered on Day 1, 8, 15 of cycle 1 and on Day 1 of cycle 2, 3, 4 and 5 (priming phase). Boost vaccinations will be administered every 3 cycles beginning from C6D1.
~Patient 4-12: DNAJB1-PRKACA peptide vaccine will be administered on Day 1, 8, 15 of cycle 1 and on Day 1 of cycle 2, 3 and 4 (priming phase). Boost vaccinations will be administered every 3 cycles beginning from C5D1.
~Drug: 0.3 mg DNAJB1-PRKACA peptide vaccine + 0.5mg Poly-ICLC
~Other Names: Hiltonol® (Poly-ICLC)"
15824458|NCT04248569|Drug|Nivolumab|"Patient 1-3: Nivolumab 3mg/kg will be administered as a 30 minute IV infusion (-10/+15min) on Day 1 of Cycle 2-5 during the priming phase. Boost/maintenance vaccinations will be administered as a flat dose of 480mg every 4 weeks starting on Day 1 of Cycle 6.
~Patient 4-12: Nivolumab 3mg/kg will be administered as a 30 minute IV infusion (-10/+15min) on Day 1 of Cycle 1-4 during the priming phase. Boost/maintenance vaccinations will be administered as a flat dose of 480mg every 4 weeks starting on Day 1 of Cycle 5.
~Drug: 3mg/kg and 480mg IV
~Other Name: OPDIVO"
15824459|NCT04248569|Drug|Ipilimumab|"Patient 1-3: Ipilimumab (1 mg/kg) will be administered as a 30 minute IV infusion (-10/+15min) on Day 1 of Cycles 2, 3, 4 and 5 of the study, every 3 weeks of the priming phase.
~Patient 4-12: Ipilimumab (1 mg/kg) will be administered as a 30 minute IV infusion (-10/+15min) on Day 1 of Cycles 1, 2, 3 and 4 of the study, every 3 weeks of the priming phase.
~Drug: 1mg/kg IV
~Other Name: YERVOY®"
15824460|NCT04248556|Other|Health care product|Health care product (gel) - to be applied on the participant's skin
15824461|NCT04248543|Device|qMRI with Gadoteridol contrast agent|quantitative MR: MRI uses a magnet and radio waves to make medical images of the body. Gadoteridol is used as a contrast agent. Quantitative MRI involves the use of software to analyze the acquired images.
15824462|NCT04248530|Device|Renal denervation|DENEX catheter is a device to treat resistant hypertension which delivers high-frequency energy through the three electrodes connected to the catheter in order to cauterize sympathetic nerve bundle.
15824463|NCT04248517|Other|mHealth Intervention|Participants will download the app onto their smartphone and complete ecological momentary assessements
15824464|NCT04248504|Other|Digital Genetic Assistant|An end-to-end digital solution to the carrier screening process from participant registration to receipt of the test results and their interpretations. These steps are provided using personalized animated videos.
15824465|NCT04248491|Device|BTL Emsella chair|Subjects will sit on the device. The RNC will turn the device on and increase the setting gradually until the patient reaches their sensory threshold. This is the maximum sensation the patient can tolerate. The treatment threshold should be increased with every treatment until the subject reaches 100%.
15824466|NCT04248478|Other|Eating Behaviours|Patients' eating behaviour will be questioned with Three Factor Eating Questionnaire. The 18-item Three-Factor Eating Questionnaire is a scale that measures three domains of eating behavior: cognitive restraint , uncontrolled eating and emotional eating.
15824467|NCT04248478|Other|Health Status|The effect of fibromyalgia on the daily life of the patients will be questioned with Fibromyalgia Impact Questionnaire (FIQ). The FIQ was developed from information gathered from patient reports, functional status instruments, and clinical observations. This instrument measures physical functioning, work status (missed days of work and job difficulty), depression, anxiety, morning tiredness, pain, stiffness, fatigue, and well-being over the past week.
15824468|NCT04248465|Drug|Placebo|Single loading dose via intravenous infusion, followed by regular maintenance dosing, based on weight.
15824469|NCT04248465|Biological|Ravulizumab|Single loading dose via intravenous infusion, followed by regular maintenance dosing, based on weight.
15824470|NCT04248452|Drug|Capecitabine|Given PO
15824471|NCT04248452|Drug|Fluorouracil|Given IV
15824472|NCT04248452|Drug|Leucovorin|Given IV
15824473|NCT04248452|Drug|Leucovorin Calcium|Given IV
15824474|NCT04248452|Drug|Oxaliplatin|Given IV
15824475|NCT04248452|Radiation|Radiation Therapy|Undergo radiation therapy
15824476|NCT04248439|Biological|RP-L102|CD34+ enriched cells from subjects with Fanconi anemia subtype A transduced ex vivo with a lentiviral vector carrying the FANCA gene
15824477|NCT04248426|Drug|ATI-2173|ATI-2173 is a liver-targeted phosphoramidate prodrug of clevudine designed to enhance anti-HBV activity while decreasing systemic exposure to clevudine. It will be dosed as a capsule by mouth.
15824478|NCT04248426|Drug|ATI-2173 Placebo|ATI-2173 Placebo is used as an inactive comparator to ATI-2173. It will be dosed as a capsule by mouth.
15824479|NCT04248413|Device|Blood Flow Restriction Therapy|The blood flow restriction cuff, which is regulated by the FDA under 878.5910 and is registered under number 9681444, is manufactured by Delfi Medical. The cuff will be used as recommended by the manufacturer and Owens Recovery Science, the company who provides certificating of blood flow restriction training.
15824480|NCT04248413|Other|Standard physical rehabilitation|Patients diagnosed with non-operative rotator cuff or biceps tendinopathy will undergo physical rehabilitation under the supervision of the same physical therapists who will be performing the BFR therapy.
15824481|NCT04248400|Other|Tai Chi training|A 24 weeks Tai Chi training with three 1-hour section per week
15824482|NCT04248400|Other|Conventional exercise|A 24 weeks conventional exercise training with three 1-hour section per week
15824483|NCT04248387|Drug|Toripalimab|Toripalimab, intravenous drip infusion, a dose of 3 mg / kg once every 2 weeks for a total of two cycles
15824484|NCT04248374|Other|Taste Intensity|Taste intensity with and without sour adaptation
15824485|NCT04248361|Diagnostic Test|TEM-PCR URI Panel|Target Enriched Multiplex Polymerase Chain Reaction (TEM-PCR™) is a breakthrough molecular multiplex technology that allows rapid DNA/RNA identification of multiple pathogens (i.e., bacteria and viruses) in a single sample, typically within one day of specimen receipt.
15824486|NCT04248361|Other|SOC/Empiric Diagnosis|The SOC for upper respiratory infection may include, but is not limited to, rapid strep testing, rapid influenza testing, and sputum cultures. In the event a lower respiratory infection is suspected a chest x-ray or CBC with differential may be performed.
15824487|NCT04248348|Drug|Low Molecular Weight Heparin|Cancer patients will be protected against thrombosis using Low Molecular Weight Heparin (LMWH)
15824488|NCT04248335|Drug|Pantoprazole|single-dose administration
15824489|NCT04248335|Drug|Midazolam injection|single-dose administration
15824490|NCT04248322|Behavioral|Semi-structured interview|Using iterative, semi-structured interviews or focus groups to explore the lived experience with CC and usual customary care (UCC) of catheter users with NLUTD and their caretakers to generate user-defined themes regarding bladder function and catheter-related barriers and the daily impacts on one's life.
15824491|NCT04248309|Drug|intramuscular progesterone 20-40mg from D3 until pregnancy test|serum progesterone <7.24ug/L, followed by randomized A1: plus additional treatment（intramuscular progesterone 20-40mg from D3 ）
15824492|NCT04248283|Device|Adjustable Continence Therapy for Women (ACT)|Two ACT devices are implanted in each patient. The devices are intended for implantation in the paraurethral space, with the balloons located on each side of the urethra near the bladder neck. The ports are placed subcutaneously in the labia majora. The balloons are filled after implantation with an isotonic solution via needle injection into the port. The ACT implant can be placed using local, spinal or general anesthesia with the surgical instruments (provided separately).
15824493|NCT04248270|Drug|18F-PM-PBB3|All scans will be acquired in pairs of 18F-florbetapir(18F-AV45) and/or18F-PM-PBB3 PET scans (if patient select), performed on separate days, and at least 2 days apart, with either scan performed first. The 18F-florbetapir and 18F-PM-PBB3 protocol will entail the inon of 5±2mCi of tracer followed by an uptake phase of 50 min during which time the state of the subject is not important. After 40 minutes, subjects will be positioned and 4 x 5 min frames of emission data will be collected right at 50 min after tracer injection. PET/MRI scans will precede this acquisition with a MRI scan for attenuation correction; PET-only scanners will perform a transmission scan following the emission scan.
15824494|NCT04248257|Behavioral|PeACE|3 session peer coaching intervention
15824495|NCT04248257|Behavioral|Community peer coaching|Peer coaching provided by community organizations that support the HBOC community
15824496|NCT04248244|Other|Palliative Care|Early PC Integration - Participants will meet with a member of the outpatient PC team, which consists of board-certified PC physicians, advance practice providers and nurse care coordinators, within three weeks of enrollment. Participants will be scheduled to meet with a PC provider at least once per month. Additional visits may be scheduled at the discretion of participants, oncologists or PC providers. All participants will receive routine oncologic care throughout the study period.
15824497|NCT04248244|Other|FACT-MM questionnaire|FACT-MM questionnaires will be administered by a research coordinator upon enrollment and at four time points from the date of enrollment: 3 months, 6 months, 9 months and 12 months. All questionnaires will be administered in handwritten paper-based form, and while patients are in clinic. There is a +/- two-week window for completion of questionnaires to accommodate patient schedules. The assessment battery takes approximately 20 minutes to complete.
15824537|NCT04247893|Device|Photobiomodulation|Photobiomodulation therapy is defined as the utilization of non-ionizing electromagnetic energy to trigger photochemical changes within cellular structures that are receptive to photons.
15824538|NCT04247893|Device|Placebo photobiomodulation|Placebo photobiomodulation - photobiomodulation device turned off.
15824498|NCT04248244|Other|HADS questionnaire|HADS questionnaires will be administered by a research coordinator upon enrollment and at four time points from the date of enrollment: 3 months, 6 months, 9 months and 12 months. All questionnaires will be administered in handwritten paper-based form, and while patients are in clinic. There is a +/- two-week window for completion of questionnaires to accommodate patient schedules. The assessment battery takes approximately 20 minutes to complete.
15824499|NCT04248231|Other|CINSARC signature|CINSARC molecular signature analysis
15824501|NCT04248205|Drug|Ketamine|Standard general anesthesia PLUS ketamine will be given for post-operative analgesia
15824502|NCT04248192|Biological|DD HST-NEETs|HIV-infected individuals following Allogeneic Bone Marrow Transplantation (alloBMT) will be treated with DD HST-NEETS therapy. Participants and donors will be screened for eligibility. Eligible donors will undergo a blood draw of up to 300mL to allow production of allogeneic DD HST-NEETs. Participants, who meet specified inclusion criteria including neutrophil recovery post-transplant and for whom donor products have passed release testing, will receive DD HST-NEETs at a dose of 2x107/m2 within 30 days of screening visit.
15824503|NCT04248179|Drug|Ropivacaine injection|Ropivacaine 5mg/ml
15824504|NCT04248179|Drug|Saline 0.9%|Saline 0.9%
15824505|NCT04248179|Drug|Sufentanil and PONV prophylaxis|30 minutes prior to emergence 0.2 μg/kg total body weight Sufentanil IV and 1 gram of paracetamol IV (if 6hrs since preoperative medicine) and 4 mg ondansetron IV (PONV prophylaxis) will be administered.
15824506|NCT04248166|Device|Photoacoustic imaging|"Photoacoustic image of thyroid nodule is obtained by using probe of photoacoustic imaging equipment and image data and data are stored in the device.
~The patient's examination is the same as the general ultrasound, and the patient is asked to hold his breath for about 3-4 seconds to get the photoacoustic image."
15824507|NCT04248153|Drug|BR55|BR55 will be administered at doses of 0.03 mL/kg or 0.05 mL/kg
15824508|NCT04248140|Other|radio frequency electromagnetic field|Exposure system delivers emissions comparable to those from WiFi access point close to the bed or sham (nor exposure)
15824509|NCT04248127|Other|Honey sweetened yogurt|2 tbsp. of daily honey intake in 1.2 cups of yogurt per day, split into two equal portions
15824510|NCT04248127|Other|Sugar sweetened yogurt|sugar added, in an isocaloric fashion to the honey, to 1.2 cups of yogurt per day, split into two equal portions
15824511|NCT04248114|Diagnostic Test|Ultrasound of the Neck|Anatomical measurements were performed on participants during an ultrasound exam
15824512|NCT04248101|Procedure|Double Ligation|
15824513|NCT04248101|Drug|Topical Silver Nitrate|
15824514|NCT04248088|Behavioral|Gentle Stretching and Education|60 minutes of gentle stretching twice weekly for 6 months
15824515|NCT04248075|Device|Electroencephalogram|Electroencephalogram is performed before, during, and 1 day after surgery in elderly patients undergoing spinal anesthesia.
15824516|NCT04248062|Other|Survey|Survey: 38 preselected patient and parent reported outcomes; rating scale: 9 point likert scale (1=not at all important - 9=very important)
15824517|NCT04248049|Other|Platelet rich fibrin|The roots of patients with diagnosis of gingival recessions will be covered with coronally advanced flap (CAF) and platelet rich fibrin (PRF) (CAF+PRF)
15824518|NCT04248036|Behavioral|Circle of Security - Parenting, COS-P|Circle of Security - Parenting is a manual-based, psychoeducational intervention program in group that includes 8 group sessions of 90 minutes each.
15824519|NCT04248023|Behavioral|Practice Facilitation|A practice facilitator will be assigned the each participating practice to assist with the development of a workflow, screening process, counseling resources, and referral resources for unhealthy alcohol use. Practices in control group will receive delayed intervention at 3 months after their matched cohort of practices.
15824520|NCT04248010|Device|neuroConn DC-Stimulator MR|standard tDCS, active & sham
15824521|NCT04248010|Device|Soterix MxN HD-tES|HD-tDCS, active & sham
15824522|NCT04247997|Procedure|disconnect pulmonary vague nerve branches|When the operation is in the right side, the Azygous vein bow is used as the marker, and in the left side, the aortic arch is used as the marker to identify the vagus nerve trunk.Then the surgeons dissect the vagus nerve trunk. This is used as a clue to find the vagus nerve pulmonary branch leading to the hilum. The position of the detachment is after the anterior and posterior pulmonary branches of the vagus nerve separating from the trunk and before the formation of the lung plexus.
15824523|NCT04247984|Biological|Bevacizumab|5 mg/kg intravenously administered on day 1 of a 2-week cycle.
15824524|NCT04247984|Drug|Capecitabine|2000mg/m2/day oral on day 1 to day 10 of a 2-week cycle.
15824525|NCT04247984|Drug|Irinotecan|180 mg/m2 intravenously administered on day 1 of a 2-week cycle.
15824526|NCT04247984|Drug|5-FU|400 mg/m2 intravenous bolus on day 1 and 2400 mg/m2 continuous infusion over 44 hours of a 2-week cycle.
15824527|NCT04247984|Drug|CF|300 mg/m2 intravenously administered on day 1 of a 2-week cycle.
15824528|NCT04247984|Drug|Irinotecan|150 mg/m2 intravenously administered on day 1 of a 2-week cycle.
15824529|NCT04247971|Procedure|Blood draw|23 ml of blood collected
15824530|NCT04247971|Procedure|Sputum collection|Induced sputum sample collected
15824531|NCT04247971|Procedure|Pulmonary function test|Pulmonary function testing
15824532|NCT04247958|Procedure|Colorectal resection|Robotic-assisted resection of the colon or rectum in subjects with benign or malignant colon or rectal disease, where SureForm™ Staplers are utilized for transection and/or creation of anastomosis.
15824533|NCT04247945|Biological|Cotransplant with MSCs|Co-transplantation of MSCs during allogeneic HSCT
15824534|NCT04247932|Behavioral|Active labor market intervention|Behavior change intervention
15824535|NCT04247906|Drug|Narsoplimab|
15824536|NCT04247893|Device|blood flow restriction|Occlusion training is an exercise approach whereby resistance exercise or aerobic exercise is performed whilst an occlusion cuff is applied to proximal aspect of the muscle.
15825346|NCT04241458|Drug|Midazolam|Midazolam
15824539|NCT04247880|Behavioral|Mentoring program|Apprentice-level female construction workers will be assigned to a mentor who has gone through a rigorous mentorship training. Participants will be asked to meet with a mentor at least 4 times/year in person to discuss the challenges of being a female in construction, learn coping mechanisms, and otherwise discuss the unique challenges of the job environment.
15824540|NCT04247867|Device|medium cut-off (MCO) dialysis membrane|Medium cut-off dialysis (MCO) membrane is a dialysis membrane with a higher molecular weight retention onset and similar cut-off as standard high-flux dialysis membranes. It is capable of providing increased clearance of medium sized uremic toxins and some plasma proteins (cytokines, inflammatory mediators).
15824541|NCT04247867|Dietary Supplement|Dietary fiber mixture (Plantago Psyllium and Inulin)|Dietary fiber (Psyllium 69% and Inulin 30% mixture) added to the meals in the dose of 5g BID for 4 weeks in the second phase of the study.
15824542|NCT04247867|Dietary Supplement|Sodium propionate|Sodium propionate (a short-chain fatty acid) added to the meals in the dose of 500 mg BID in the second phase in the study.
15824543|NCT04247854|Dietary Supplement|Bacillus subtilis probiotic|Bacillus probiotic which contains one confidential ingredient of Bacillus subtilis spores (2 x 1010 CFU/g). Over 5 days of interventional period, the patient receives one tablet (250 mg; 5 x 109 CFU) of probiotic per day.
15824544|NCT04247854|Other|Placebo|Over 5 days of interventional period, the patient receives 1 placebo tablet per day
15824545|NCT04247841|Other|Visual Aid|The visual aid will include a graphic display of 100 individuals with number of individuals anticipated to suffer a myocardial injury highlighted by being filled in in red. There will also be a textual discription stating the anticipated risk. For example in a patient with an rCRI score = 2 the text will state 10 out of 100 patients will have a myocardial injury (MINS) and 90 out of 100 patients will have no myocardial injury and 10 of the patients will be shaded red on the visual aid. The patients in this intervention will also received the scripted discussion of perioperative risk of MINS.
15824546|NCT04247841|Other|Scripted Risk Discussion|The patients seen in PSS will have a standardized discussion of perioperative risk of myocardial injury read to them by the anesthesiologist in the PSS clinic.
15824547|NCT04247828|Device|Adaptive and individualized communication interface (AAC device)|Patient-centric smart-AAC system comprised of a single hybrid wearable sensor for head-mediated cursor control that is integrated with an adaptable alphabetic interface for communication.
15824548|NCT04247828|Device|Generic communication interface (AAC device)|Generic AAC system comprised of a single hybrid wearable sensor for head-mediated cursor control that is integrated with a non-adaptable alphabetic interface for communication.
15824549|NCT04247815|Drug|ATI-450|Oral, small molecule MK2 inhibitor
15824550|NCT04247815|Drug|Placebo oral tablet|Placebo tablet manufactured to match ATI-450 in appearance
15824551|NCT04247815|Drug|Methotrexate|7.5 mg to 25 mg weekly
15824552|NCT04247802|Other|Backwards Walking (BW) programme|A 12 week Backwards walking programme prescribed by a registered physiotherapist and completed as part of a home exercise programme.
15824553|NCT04247802|Other|Usual Care|A 12 week physiotherapy exercise programme EXCLUDING backwards walking
15824554|NCT04247789|Other|Self-reported questionairres|the fatigue will be determined through self reported questionnairres
15824555|NCT04247776|Combination Product|Prehab|Exercise: functional exercises, walking, Fitbit goals Nutrition: handout, supplements (protein, vitamins, minerals) Stress reduction: deep breathing
15824556|NCT04247776|Other|ERAS|Enhanced Recovery After Surgery guidelines are applied.
15824557|NCT04247776|Behavioral|Fitbit|Fitbit is worn to monitor step counts.
15824558|NCT04247763|Other|Saturated Fat Meal|
15824559|NCT04247763|Other|Oleic Sunflower Oil Meal|
15824560|NCT04247750|Drug|Sirolimus 0.5 mg|Daily administration of 1 or more tablets
15824561|NCT04247737|Other|gluten free diet|Participants keep a gluten free diet for six weeks
15824562|NCT04247724|Behavioral|Recreational handball|
15824563|NCT04247724|Behavioral|Control|
15824564|NCT04247711|Behavioral|OTCH|OTCH is structured in three phrases (i. engagement and initial needs assessment, ii. ongoing intervention and monitoring, and iii. transition to long-term services) and lasts an average of two years. OTCH will maintain the central characteristics of the OnTrack model, as well as its core principles, which include (1) Person-centered care, (2) Shared decision-making, (3) Recovery orientation, and (4) Culturally-competent care.
15824565|NCT04247711|Behavioral|Usual FEP Services|These include services such as psychiatric medication, psychotherapy, and psychoeducation for people with FEP and are usually provided at outpatient mental health clinics.
15824566|NCT04247685|Device|12-lead ECG monitoring device (MiRTLE Medical)|12-lead ECG monitoring device produced by a Massachusetts-based medical device company MiRTLE Medical is the experimental device;
15824567|NCT04247685|Device|3-lead ECG gating system|3-lead ECG gating system is the placebo/standard of care
15824568|NCT04247672|Device|Total Knee Arthroplasty (uncemented rotating platform ATTUNE)|All patients receive an uncemented ATTUNE rotating platform knee system.
15824569|NCT04247659|Drug|sodium aescinate|The main mechanism of sodium aescinate includes anti - inflammatory, anti - exudate anti - oxygen free radical ,anti - edema increased venous tension.The treatment course of sodium aescinate is 10 days,20mg/day, intravenous infusion.
15824570|NCT04247646|Dietary Supplement|Melatonin|Participants will take sublingual melatonin (or placebo) nightly for 29 doses after undergoing total knee replacement surgery.
15824571|NCT04247646|Dietary Supplement|Placebo|Participants will take sublingual melatonin (or placebo) nightly for 29 doses after undergoing total knee replacement surgery.
15824572|NCT04247633|Drug|Palbociclib|Palbociclib at a dose of 125 mg will be administered orally once a day for 21 days, followed by 7 days off treatment of every 28 day cycle. Investigational medicinal product (IMP) will be administered with standard adjuvant endocrine therapy (Non-investigational treatment).
15824600|NCT04247347|Behavioral|Resourcefulness Training|A cognitive-behavioral intervention presented within an audiovisual format using a tablet computer that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
15824601|NCT04247334|Device|Transcranial direct current stimulation|20 minutes of 2 milliamp transcranial direct current stimulation
15824602|NCT04247321|Device|Licox® Brain Tissue Oxygen Monitoring System|Invasive brain tissue oxygenation monitoring
15824573|NCT04247620|Behavioral|DiaBetter Together|"Following an intervention manual, the Peer Mentor will teach behavioral strategies and offer support to the young adult, including (a) teaching and modeling strengths-based skills for goal-setting, problem-solving, and stress management; (b) guiding participants in obtaining support from their social support network (e.g., family, friends); (c) developing a plan for accountability around diabetes management and follow-up in adult care; (d) sharing his/her transition experiences and strategies for successfully navigating the adult healthcare system; (e) discussing how to prioritize diabetes self-care; and (f) assisting them in accessing diabetes-related resources (e.g., local diabetes groups, apps, social media).
~Contact will be in-person and by telephone, email, text messaging, and/or video chat, approximately weekly for first 6 mos, and approximately monthly for second 6 mos.
~Participants will receive the intervention in addition to usual diabetes care."
15824574|NCT04247620|Behavioral|Peer Mentor Delivery|Peer Mentors deliver the intervention to multiple young adult participants, each for 12 months. Peer Mentors may take on one or more participants at a time, and Peer Mentors may stay in their role in the study (delivering the intervention) for 1-3 years.
15824575|NCT04247594|Drug|Voxelotor|synthetic small molecule supplied as 500 mg tablets
15824576|NCT04247581|Device|1-lead ECG|"1 lead ECG - All participants will record three single-lead ECGs at rest and three single-lead ECGs after exercise.
~Intervention Other: Exercise - All participants will undergo three trials of exercise.
~Other interventions: 12-lead ECG - All participants will simultaneously record 12-lead ECGs during rest and exercise sessions."
15824577|NCT04247568|Other|Listening to an audiotape|The participants listen to a audiofile that consists of hypnosis
15824578|NCT04247542|Drug|Ibezapolstat|Investigational antibacterial agent
15824579|NCT04247542|Drug|Vancomycin|Active comparator
15824580|NCT04247529|Other|Exposure to conflicting health information|At 2 time points across a ~28-day period, participants will be exposed to news stories and social media posts about 6 health topics: mammography screening, prostate-specific antigen (PSA) testing, Vitamin D supplementation, carbohydrate consumption, alcohol consumption, and breastfeeding. Participants in the conflict (experimental) group will have conflicting information added to these news and social media posts.
15824581|NCT04247529|Other|No exposure to conflicting health information|At 2 time points across a ~28-day period, participants will be exposed to news stories and social media posts about 6 health topics: mammography screening, prostate-specific antigen (PSA) testing, Vitamin D supplementation, carbohydrate consumption, alcohol consumption, and breastfeeding. Participants in the no conflict (comparator) group will have no conflicting information included in these news and social media posts.
15824582|NCT04247516|Behavioral|Online-intervention group I (IGI)|Narrative-based online intervention program to promote self-regulatory competences.
15824583|NCT04247516|Behavioral|Online-intervention group II (IGII)|Narrative-based online intervention program to promote self-regulatory competencies plus gamification strategies.
15824584|NCT04247490|Diagnostic Test|pediatric AIH|pediatric patients with clinical, laboratory (transaminase and IgG increase), instrumental (ultrasound, liver biopsy) characteristics
15824585|NCT04247477|Other|Ventilation strategy|Patients are ventilated in randomized order with three different ventilation strategies (A,B and C)
15824586|NCT04247464|Procedure|Fasting|Food intake restriction
15824587|NCT04247451|Diagnostic Test|Metabolic profile and nutritional goals in diabetic foot surgery patients|"Nutritional intake: these data will be evaluated daily during preoperative hospitalization, at home, and during the actual hospitalization, from surgical intervention to discharge. Before the follow-up consultation, patients will keep a food diary. The dieticians will calculate intake and need.
~Metabolic data: body composition using Bio electrical Impedance Analysis BIA (Nutrilab Akern) and Resting Energy Expenditure REE using indirect calorimetry (Cosmed Q NRG) will be analysed in three timepoints: preoperative, postoperative and at follow-up consultation. This measurements take maximum ten minutes and do not cause discomfort to the participants."
15824588|NCT04247438|Other|12h and 36h Biofilm formation on PMMA (Palapress®) dentures and samples worn by participants and brushing cycles needed to remove it.|"Capturing the clinical data for biofilm formation on PMMA dentures and samples worn by participants and the number of brushing cycles required to remove this biofilm.
~Development of artificial denture biofilm substitute with similar mechanical properties to real denture biofilm."
15824589|NCT04247425|Other|Exercise Counseling|Receive instructional guidance
15824590|NCT04247425|Other|Quality-of-Life Assessment|Ancillary studies
15824591|NCT04247425|Other|Questionnaire Administration|Ancillary studies
15824592|NCT04247425|Other|Resistance Training|Complete progressive resistance training
15824593|NCT04247399|Other|Simulation-based learning|Pre-clinical simulation-based learning at Simbionix GI-mentor II virtual reality simulator and OGI CLA 4 phantom.
15824594|NCT04247386|Drug|PEG-Mizone|"The evening before the colonoscopy:60gPEG-4000 was mixed with 0.6LMizone and 0.4L water.
~On the day of the colonoscopy:4-6 hours before colonoscopy, 120gPEG-4000 was mixed with 1.2LMizone and 0.8L water."
15824595|NCT04247386|Drug|PEG-ELS|The evening before the colonoscopy:60gPEG-4000 was mixed with 1L water. On the day of the colonoscopy:4-6 hours before colonoscopy, 120gPEG-4000 was mixed with 2L water.
15824596|NCT04247373|Drug|Ropivacaine|According to previous patient's response, the investigators will allocate the concentration of ropivacaine of next patient during Co2 insufflation. And, for this allocation of concentration of ropivacaine the investigators use biased coin design up-and-down method.
15824597|NCT04247360|Device|cuff pressure|maintaining cuff pressure according the groups
15824598|NCT04247347|Behavioral|Biofeedback Training|"Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate feedback to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and to continue to influence behavior."
15824599|NCT04247347|Other|Dementia Education|An educational program designed to teach family caregivers about the characteristics, types, causes, and risk factors of dementia, as well as teach about health promotion, the stages of dementia, behavior changes, communicating with a family member with dementia, and caring for oneself. The content to be presented within an audiovisual format using a tablet computer follows recommendations and guidelines developed through research and by the Alzheimer's Association and the National Institute on Aging.
15824603|NCT04247321|Device|Near-infrared spectroscopy (NIRS)|Non-invasive approach to monitoring brain tissue oxygenation which uses two wavelengths of near infrared light and takes measurements of the ratio of oxyhemoglobin to total hemoglobin
15824604|NCT04247308|Other|Sensory Stimulation|Auditory, tactile, visual, vestibular and oro motor stimulation
15824605|NCT04247308|Other|Movement therapy|Passive range of movements, antigravity movements in prone and supine
15824606|NCT04247308|Other|Routine hospital care|Maintaining the vitals
15824607|NCT04247295|Device|Traditional Cast|Application of a traditional cast
15824608|NCT04247295|Device|Woodcast|Application of a woodcast
15824609|NCT04247282|Drug|M7824|M7824 (1200 mg) will be administered intravenously on day 1 and 15 to patients enrolled in arm 1-3 (all three arms).
15824610|NCT04247282|Drug|N803|N-803 (15 mcg/kg, subcutaneously) will be given on day 1 to patients enrolled in arm 3.
15824611|NCT04247282|Biological|TriAd vaccine|TriAd vaccine (5 x 10e11 VP; subcutaneous injection) will be given on day 1 to patients enrolled in arm 2 and arm 3
15824612|NCT04247269|Other|Enteral Tube Feeding|Enteral tube feeding
15824613|NCT04247256|Drug|FOLFIRI Protocol|FOLFIRI standard treatment on day 5 to 7 (both days included) of a 14 day period. repeated bi-weekly
15824614|NCT04247256|Drug|SCO-101|Investigational Medicinal Product, oral tablet administered on day 1 to 6 (both days included) of a 14 day period. repeated bi-weekly
15824615|NCT04247243|Device|Rapid testing|Abbott ID NOW Strep A testing
15824616|NCT04247243|Diagnostic Test|Reference testing|Culture-based testing
15824617|NCT04247230|Drug|Tetracaine|Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.
15824618|NCT04247230|Other|Matching placebo (PET500)|Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.
15824619|NCT04247230|Drug|STUD100|Von Frey hair (monofilaments) was used to assess the changes in touch sensitivity on the glans penis after the application of IMP.
15824620|NCT04247217|Radiation|HDR salvage brachytherapy|In patients receiving HDR salvage brachytherapy for locally relapsed prostate cancer serial biopsies will be performed at 4 different time points.
15824621|NCT04247204|Biological|Platelet-rich plasma intrauterine infusion|For all women, basic transvaginal sonography will be done in the 2nd day of frozen embryo transfer (FET) cycle and they will receive standard hormone replacement therapy (HRT) in the form of estradiol valerate tablets (white tablets of Cyclo-Progynova; Bayer Schering Pharma AG, Germany) at a dose of 4mg for 7 days then 6mg for 6 days. Endometrial assessment will be done on day 15 of FET cycle. Those with endometrial thickness between 8-14 mm will be evaluated for endometrial and sub-endometrial vasculature pattern by 3D power Doppler analysis. Then 1 ml of PRP (prepared from autologous blood) will be infused in the uterine cavity and vaginal progesterone 400 mg twice daily will be prescribed for 3 days. Subsequently, D3 embryos will be transferred. Endometrial, sub-endometrial and uterine arterial vascularity pattern will be re-evaluated on the day of ET. Both estradiol valerate tablets and vaginal progesterone will be continued up to 12th week of gestation in case of pregnancy.
15824622|NCT04247191|Behavioral|P-Chat|The P-Chat is a brief individually delivered intervention based on the principles of Motivational Interviewing (MI) and focuses on increasing parents' motivation to reduce permissiveness toward underage alcohol use while reducing defensiveness and barriers to implementing these rules with their teen.
15824623|NCT04247191|Behavioral|PBI|"The PBI is currently a model prevention resource at NIAAA's College Alcohol Intervention Matrix and the research was discussed in the most recent Surgeon General's Report as one of the two prevention approaches that met the rigorous criteria to be considered efficacious. The first section of the PBI provides an introduction to the problem of substance use. The second section focuses on specific skill building strategies that parents can use to improve communication channels with their teen. Third, is a section that addresses peer influence and provides strategies for developing assertiveness. The fourth section is an in-depth discussion of underage drinking, physiological and psychological effects, mixing alcohol with other drugs, motives for why students drink and don't drink, warning signs, risky binge-type drinking, impaired driving, riding with impaired drivers, alcohol and sexual assault, and how to communicate about parents' experiences when they were young."
15824624|NCT04247191|Behavioral|P-Chat+|The P-Chat+ is a combination of the P-Chat and PBI described above. Parents in this arm of the study will receive both interventions.
15824625|NCT04247165|Drug|Gemcitabine|800 mg/m2 Day 1, 8, 15: Q4W IV Infusion
15824626|NCT04247165|Drug|Nab-paclitaxel|100 mg/m2 Day 1, 8, 15: Q4W IV Infusion
15824627|NCT04247165|Drug|Nivolumab|3 mg/kg Day 1, Q4W IV Infusion
15824628|NCT04247165|Drug|Ipilimumab|1 mg/kg Day 1 Cycle 1 IV Infusion
15824629|NCT04247165|Radiation|SBRT|"Patients will be planned and treated with SBRT on a MRidian MR guided Linac.
~Prescription dose shall be according to the following specifications:
~Prescription dose shall be according to the following specifications:
~A total dose of 24 Gy in 3 fractions (3 fractions/week) are prescribed as the mean dose to the PTV.
~Pauses are accepted but the treatment should be delivered within 10 calendar days.
~PTV should be covered by 95% isodose (PTV D99% >95%)."
15824630|NCT04247152|Other|Intraoperative Aberrometry vs preoperative biometry|Hypothesis: Intraoperative aberrometry measures lower levels of astigmatism more accurately than preoperative biometry in patients undergoing cataract surgery.
15824631|NCT04247139|Other|Kefir|commercial versus traditional kefir
15824632|NCT04247126|Drug|SY-5609|An oral CDK7 Inhibitor
15824633|NCT04247126|Drug|Fulvestrant|estrogen receptor antagonist
15824634|NCT04247113|Behavioral|Parent-based prevention following bariatric surgery|PBP-B is an adapted version of Parent-Based Prevention (PBP), an innovative approach with demonstrated efficacy in targeting the familial effects of parents with eating disorders on their young children's healthy behaviors. PBP-B addresses the parental cognitions and behaviors that putatively increase the risk for maladaptive outcomes in their children.
15824635|NCT04247100|Device|Transcutaneous Electrical Nerve Stimulation (TENS)|Active Transcutaneous Auricular Microstimulation delivered by TENS device
15824636|NCT04247100|Device|Sham Transcutaneous Electrical Nerve Stimulation|Sham therapy will be delivered by applying the TENS device with non-conductive electrodes so that no microstimulation is delivered
15824637|NCT04247087|Drug|phytomenadione|phytomenadione 10 mg (1 vial in the venous line of the extracorporeal hemodialysis circuit) post hemodialysis 3 times a week for 12 months
15824640|NCT04247074|Biological|Placebo|Placebo will be injected into either the LCL, GL, or both the LCL and GL
15824641|NCT04247061|Other|Educational video|One of two different 10 minute educational videos on smoking cessation will be viewed by participants during a dental cleaning visit. The video that is watched will depend on participants' level of motivation to quit and project needs
15824642|NCT04247061|Other|Text-message program|A one-month text message program to motivate and facilitate contact with smoking cessation resources.
15824643|NCT04247048|Other|infusion of tracer [5,5,5-2H3] -L-leucine|A bolus of 6ml of [5,5,5-2H3] -L-leucine tracers will be performed followed by an infusion of 90 ml of [5,5,5-2H3] -L-leucine infused over 14 hours. This tracer participates in protein synthesis and especially in the synthesis of all apolipoproteins and PCSK9. Blood samples will be taken at T0, T2min, T5min, T10 minutes, T30 minutes and then every hour until 14 hours (a total of 240 ml of blood will be collected) to measure the stable tracer enrichment in the proteins of interest.
15824644|NCT04247022|Other|Health care product (intimate gel)|heath care product (intimate gel) for home use, under real conditions of use, for 28 ± 2 days
15824645|NCT04247009|Other|Meal based on red meat, fish products or vegan products|Three meals will be served
15824646|NCT04247009|Other|Meal based on red meat|Matched Controls will be served only one meal of meat to compare response between (non-RA) matched controls and patients with RA
15824647|NCT04246996|Drug|gentamicin sulfate|Subjects in the gentamicin arm will receive an bladder instillation of 80mg of gentamicin sulfate in 50 mL of normal saline through a standard-of-care Foley catheter.
15824648|NCT04246996|Other|Catheter clamping only|Subjects in the control arm will have their standard-of-care transurethral catheter clamped for 1 hour post-placement to maintain subject masking to study arm.
15824649|NCT04246983|Diagnostic Test|Opportunistic infection Ultrasound (OpUS) screening|this point-of-care ultrasound protocol will include lung ultrasound, assessment of pericardial and pleural effusions, ascites, abdominal lymphadenopathy and splenic micro abscesses, as well as a focused ultrasound of liver and kidneys.
15824650|NCT04246970|Other|Prehabilitation|Supervised training program of 8-weeks and a frequency of 2 days/week. It includes interval aerobic exercise (5 cycles of 2 minutes at 70 percentage of Watts or heart rate of cardiopulmonary exercise testing (CEPT) and 3 minutes of active rest at 40 percentage; peripheral muscle training and balance exercises in a circuit of 10 phases, 10 to 15 repetitions, from 1 to 3 sets (the participants will work at moderate intensity, no more than 5-6/10 on the modified Borg scale); Inspiratory Muscle Training (IMT) through a threshold loading device [2 sessions / day, 3 sets of 15 repetitions, at 60-70 percentage of the maximum inspiratory pressure (cmH2O)]; ventilatory reeducation by an incentive inspirator based on the vital capacity evaluated in the initial spirometry. Both the aerobic modality and the resistance training, will increase the intensity of work (HR, Watts, Kg or cmH2O) between 2-5 percentage every 2 weeks complying with the principle of training overload.
15824651|NCT04246970|Other|Prehabilitation and posttransplant training program|Prehabilitation will be followed by a posttransplant training program. In this, the patient will perform supervised exercise (IIa interval aerobic exercise and resistance training) 2 days / week, and a physical exercise program at home until completing a total of 5 sessions / week in the aerobic modality. In the unsupervised phase (IIb), the patient will continue with the learned physical exercise program, but without supervision, 5 sessions / week (including a minimum of 2 non-consecutive sessions to perform resistance training).
15824652|NCT04246957|Behavioral|general quality of life questionary|Every patient will have to fill out a general quality of life questionary : DLQI (Dermatology Life Quality Index)
15824653|NCT04246957|Behavioral|specific quality of life questionary|Every patient will have to fill out a specific quality of life questionary : Hair Specific Skindex 29.
15824654|NCT04246944|Procedure|harvesting induced membrane|The induced membrane will be harvested during the second step of the bone reconstruction.
15824655|NCT04246931|Other|No intervention (survey)|No intervention -> survey at 1 timepoint
15824656|NCT04246918|Dietary Supplement|Branched Chain Amino Acid|Branched chain amino acid is a group of three amino acids known for there role in muscle growth.
15824657|NCT04246918|Dietary Supplement|Whey Protein concentrate powder|Whey protein will be given to the standard treatment arm including in the same amount of 1.5gm/kg/IBW.
15824658|NCT04246905|Drug|sulforaphane|To examine the add-on effect of sulforaphane in depression patients with selective 5 - HT reuptake inhibitors (SSRI) treatment
15824659|NCT04246905|Other|placedo|To examine the add-on effect of sulforaphane in depression patients with selective 5 - HT reuptake inhibitors (SSRI) treatment
15824660|NCT04246905|Drug|selective 5 - HT reuptake inhibitors (SSRI)|To examine the add-on effect of sulforaphane in depression patients with selective 5 - HT reuptake inhibitors (SSRI) treatment
15824661|NCT04246879|Other|MRI|Subjects undergo one additional delayed MRI sequence
15824662|NCT04246866|Biological|GEM103|GEM103
15824663|NCT04246853|Device|Transcranial direct current stimulation (tDCS) of the resting state motor network|Transcranial direct current stimulation (tDCS) delivers a low intensity current of up to 4 mA per session through small and circular shaped electrodes applied over the scalp. This induces a weak but focal electrical field that may modify the excitability of the underlying cortical target in a polarity and activity dependent fashion.
15824664|NCT04246827|Behavioral|Enhanced Lifestyle Weight Management|The Enhanced Lifestyle Weight Management program was a 12-week protocol in which training in coping skills to increase self-efficacy and decrease the impact of RA pain on behavioral (e.g., activity, eating) and psychosocial (e.g., mood, relationships) weight loss factors were integrated into a lifestyle behavioral weight loss intervention.
15824665|NCT04246814|Device|LG1|Application of LASER AsGa 904nm 10 J/cm².
15824666|NCT04246814|Device|LG2|Application of LASER AsGa 904nm 8 J/cm².
15824667|NCT04246814|Device|LG3|Application of LASER AsGa 904nm 4 J/cm².
15824668|NCT04246814|Device|CC|Application of placebo LASER.
15824669|NCT04246814|Procedure|Dressing|Application of Helianthus annuus oil dressing.
15824672|NCT04246788|Other|Intensive robotic rehabilitation|5 sessions per week of 30 minutes of robot-assisted rehabilitation with the G-EO system during two weeks
15824673|NCT04246788|Other|classical physiotherapy|3 sessions per week of 30 minutes of classical physiotherapy during two weeks
15824674|NCT04246775|Device|Peristeen|rectal irrigation
15824675|NCT04246762|Drug|Olokizumab|Sterile solution for subcutaneous (SC) injection, 128 mg (0.8 mL injection)
15824676|NCT04246762|Drug|Omeprazole|Tablets, 20 mg, oral
15824677|NCT04246762|Drug|Caffeine|Tablets, 100 mg, oral
15824678|NCT04246762|Drug|Warfarin+ Vitamin K|Warfarin -Tablets 10 mg,oral. Vitamin K - solution for intravenous injection, 10 mg/mL ampoule
15824679|NCT04246762|Drug|Midazolam|Syrup, 2 mg/mL, oral
15824680|NCT04246749|Drug|[14C]-CRN00808|Investigational drug
15824681|NCT04246749|Drug|CRN00808|Investigational drug
15824682|NCT04246736|Behavioral|Bädda för Kvalitet|"A group-administered preventive programme focusing on beneficial strategies for sleep and recuperation, in relation to work related stress and shift work. The intervention was based on knowledge from previous research on sleep, stress and work hours, as well as on cognitive behavioural therapy (CBT) techniques for sleep and stress management, modified for shift workers. Participants were encouraged to discuss and reflect on personal habits related to sleep and recovery. As homework between sessions, the participants were encouraged to try possibly beneficial strategies for sleep and recuperation. All participants got written material covering the content of the session, during each sessions. In addition, an adapted version of a biomathematical model (ArturNurse) was used to give participants an estimation of expected sleep lengths and fatigue levels together with tips of possible strategies to optimise sleep in relation to different shifts."
15824683|NCT04246723|Drug|Narlaprevir|100 mg oval shaped, concave, yellow film-coated tablets taken as 200 mg per os once daily. 28 tabs/36 tabs/ 56 tabs in bottle.
15824684|NCT04246723|Drug|Ritonavir|100 mg tablets taken as 100 mg per os once daily. 30 tablets in bottle
15824685|NCT04246723|Drug|Sofosbuvir|"400 mg yellow, capsule-shaped film-coated tablets debossed with GSI on one side and 7977 on the other side, taken as 400 mg per os once daily. 28 tablets in bottle."
15824686|NCT04246697|Drug|Tylenol|Used for both arms, scheduled
15824687|NCT04246697|Drug|Oxycodone|Used for both arms PRN
15824688|NCT04246697|Drug|Morphine|Used for both arms PRN
15824689|NCT04246697|Drug|Gabapentin|Used for Arm B
15824690|NCT04246697|Drug|toradol|Used for Arm B
15824691|NCT04246697|Drug|Bupivacaine|Used for Arm B - anesthesia block
15824692|NCT04246684|Drug|Oxaliplatin, 85 mg/m2|85 mg/m2,2h-civ, day 22, 36, 50, 64, 78, 92, 106, 120, and 134 of therapy
15824693|NCT04246684|Drug|5FU; 2400 mg/m2|2400 mg/m2, 46h-civ, day 22, 36, 50, 64, 78, 92, 106, 120, 134 of therapy for Control arm
15824694|NCT04246684|Drug|5FU, 250 mg/m2|250 mg/m2 per day, civ, on day 1-14, day 22-35 of radiotherapy;
15824695|NCT04246684|Drug|5FU, 2400 mg/m2|2400 mg/m2,46h-civ, d64, d78, d92, d106, d120, d134 of therapy
15824696|NCT04246684|Drug|Oxaliplatin 50 mg/m2|50 mg/m2, 2h-civ, d1, d8, d21, d29 of radiotherapy and
15824697|NCT04246684|Drug|Folinic Acid, 400 mg/m2|2h-civ day 22, 36, 50, 64, 78, 92, 106, 120, and 134 of therapyfor Control arm; 400 mg/m2, 2h-civ d 64, d78, d92, d106, d120, d134 of therapy for experimental arm
15824698|NCT04246684|Radiation|Radiotherapy control, 5x5 Gy: 25 Gy|Control arm: 5x5 Gy (total: 25 Gy) 5 fractions
15824699|NCT04246684|Drug|Capecitabine, 1000 mg/m2|1000 mg/m2 (twice daily) day1-14 every three weeks instead of 5FU optional
15824700|NCT04246684|Drug|Oxaliplatin 85 mg/m2|85 mg/m2, 2h-civ, d64, d78, d92, d106, d120, d134 of therapy
15824701|NCT04246684|Radiation|radiotherapy experimental, 30 x 1,8 Gy: 54 Gy|30 x 1.8 Gy (total: 54 Gy), 5 fractions per week
15824702|NCT04246684|Drug|Capecitabine, 825 mg/m2|825 mg/m2 bid, per os, on day 1-14, 22-35 of RT instead of 5FU optional
15824703|NCT04246684|Drug|Oxaliplatin, 130 mg/m2|day1every three weeks (optional)
15824704|NCT04246671|Biological|TAEK-VAC-HerBy|TAEK-VAC-HerBy will be administered intravenously every three weeks with three administrations in total at the dose indicated by the enrolled cohort. It may also be administered concurrently with a HER2 antibody or a checkpoint inhibitor depending on the trial stage.
15824705|NCT04246658|Other|conventional physical therapy program|traditional physical therapy program
15824706|NCT04246658|Other|gait training on platform swing walkway|gait training on platform swing walkway for 30 minute.
15824707|NCT04246645|Other|CORE STABILITY EXERCISES|SELECTED CORE EXERCISES
15824708|NCT04246632|Device|CapsoCam Colon Capsule Endoscopy|CapsoCam® Colon is intended to provide visualization of the colon and the detection of colon polyps in adults.
15824709|NCT04246619|Drug|Pregabalin|"Pregabalin Krka (pregabalin) hard capsules of different strenghts: 25 mg, 75 mg, 150 mg, 300 mg.
~Duration: 12 weeks"
15824710|NCT04246619|Drug|Duloxetine|"Dulsevia® (duloxetine) hard gastro-resistant capsules of different strenghts: 30 mg and 60 mg.
~Duration: 12 weeks"
15824711|NCT04246606|Diagnostic Test|IHC4 score|"The IHC4 score is a prognostic tool that incorporates immunohistochemical parameters of ER (H-score), PR (% of positive cells), HER2 (positive or negative status), and Ki67 (% of positive cells).
~IHC4 score, combined with nodal status and tumor grade, age, and the type of endocrine therapy (tamoxifen or aromatase inhibitors) provides a clinical score IHC4+C.
~IHC4+C provides a prognostic risk of distant recurrence at 10 years for patients who underwent endocrine therapy for 5 years. IHC4+C defined three distinct risk categories:
~<10%: low risk
~[10-20%]: intermediate risk
~>20%: high risk"
15824712|NCT04246593|Other|Mobile Market program implementation|"Mobile Market program implementation includes utilizing a Veggie Van model which sells reduced cost locally-grown produce in communities with barriers to accessing fresh F&Vs because of availability, cost, or lack of produce preparation skills.The Veggie Van visits sites that already serve the target market (e.g., lower-income housing communities, community health centers, community colleges). While Mobile Market programs vary in their model and operation, we believe that the three components of Veggie Van's success are it's share model, price reductions (incentives), and educational component"
15824713|NCT04246580|Procedure|Indocyanine green-guided systematic pelvic lymphadenectomy|Injection of Indocyanine green within the uterine cervix before to perform laparoscopic/robotic systematic pelvic lymphadenectomy
15824714|NCT04246567|Procedure|Mean Blood Pressure (MBP)|Mean blood pressure (MBP) for patients 50-65 mmHg
15824715|NCT04246567|Drug|Add to 0.5 mcg / kg fentanyl.|When BIS values are between 40-60 and muscle relaxation was sufficient (TOF 0), a 20% increase in the initial blood pressure and heart rate values of patients were added to 0.5 mcg / kg fentanyl.
15824716|NCT04246554|Drug|Ketorolac|Oral ketorolac for pain control following ACL reconstruction surgery
15824717|NCT04246554|Drug|Oxycodone-Acetaminophen|Oral oxycodone-acetaminophen for post-operative pain control
15824718|NCT04246541|Drug|Ketorolac|Patients will receive IV ketorolac during surgery followed by 3 days of oral ketorolac (10 mg every 6 hours) for pain control. Patients will also be given oxycodone-acetaminophen (5mg-325mg) PRN for pain not controlled with ketorolac.
15824719|NCT04246541|Drug|Oxycodone-Acetaminophen|Patients will be discharged with oxycodone-acetaminophen (5mg-325mg) PRN for pain control after surgery.
15824721|NCT04246515|Device|Blood Flow Restriction Training|Vascular occlusion of the injured limb.
15824722|NCT04246515|Device|Sham Blood Flow Restriction Training|Blood Flow Restriction material will be attached to the limb without vascular occlusion.
15824723|NCT04246515|Other|Classic rehabilitation|Classic rehabilitation protocol after a hamstring injury consisiting out of stretching, strength, core stability,...
15824724|NCT04246502|Drug|Capecitabine and Pyrotinib|Pyrotinib 400mg orally daily until progressive disease
15824725|NCT04246502|Drug|Capecitabine,Trastuzumab, and Pertuzumab|as instruction
15824726|NCT04246489|Drug|Bintrafusp alfa|Participants will receive an intravenous infusion of 1200 milligrams (mg) bintrafusp alfa once every 2 weeks until confirmed disease progression, death, unacceptable toxicity and study withdrawal.
15824727|NCT04246476|Behavioral|Mentally singing|All participants (people with PD and age-matched controls) sing their song in their head and match their footfalls or finger tapping to the beat.
15824728|NCT04246476|Behavioral|Listening to music|All participants (people with PD and age-matched controls) listen to their song and match their footfalls or finger tapping to the beat.
15824729|NCT04246463|Device|Thoracic|Implant of a Relay stent graft system
15824730|NCT04246463|Device|Abdominal|Implant with an Anaconda or Treo Stent graft system
15824731|NCT04246463|Device|Custom Device|Implant of a Fenestrated device such as Fenestrated Anaconda or Fenestrated TREO, Relay Branch or other customised device
15824732|NCT04246463|Device|Illiac Artery|Implant with an Anaconda Iliac leg only
15824733|NCT04246450|Device|Implantable Cardioverter Defibrillator (ICD) insertion|Implantation of ICD when arrhythmic risk is deemed high in those with LVEF between 35%-50%, and to all with LVEF<35%. Aim to determine whether risk stratification accuracy can be improved more than that of the current approach regarding primary prevention of sudden cardiac arrhythmic death in nonischemic dilated cardiomyopathy patients (no ICDs to those with LVEF between 35%-50% and ICDs to all with LVEF <35%. In patients in the LVEF <35% groups, ICDs will be used as implantable recorders, to determine whether occurrence of major arrhythmic events (MAEs) can be better predicted by NIRFs/PVS than by LVEF alone.
15824734|NCT04246437|Drug|[18F]FDOPA|Patients will receive a 3-D emission scan following a 6-8 mCi slow bolus injection of [18F]FDOPA over a 30 second period. Serial scans are started simultaneously with the bolus injection of radiotracer and are obtained for approximately 95 minutes.
15824735|NCT04246437|Drug|Carbidopa 200mg oral dose|30 minutes prior to the PET scan, patients will receive the 200mg oral dose of carbidopa to prevent peripheral [18F]FDOPA metabolism to increase signal-to-noise ratio of the imaging.
15824736|NCT04246437|Drug|Entacapone 400mg oral dose|30 minutes prior to the PET scan, patients will receive the 400mg oral dose of entacapone to prevent peripheral [18F]FDOPA metabolism to increase signal-to-noise ratio of the imaging.
15824737|NCT04246424|Behavioral|Fibit + Coaching|This intervention is a combination of the coaching and fitbit interventions
15824738|NCT04246424|Behavioral|Coaching|"Coaching Participants who are assigned coaching group will receive telephone coaching. Coaches follow a guide developed by Kelly Glazer Baron, Jennifer Duffecy, Kathryn Reid, and Lauren Caccamo. The first session is an approximately 30 minute engagement session, with the purpose of getting to know the participant to increase likelihood for participation. The end goal is to have participants express Desire, Ability, Reason, Need, Can (DARN-C) to make changes in sleep). The remainder calls (week 2-6) are follow-up calls lasting about 5 minutes. The goal of these calls is to keep participants motivated and address any issues with the Fitbit hard or software.
~Participants will also receive weekly email lessons to their personal email address for 1-6 weeks."
15824739|NCT04246424|Behavioral|Fitbit|Fitbit Participants in the fitbit group will receive a Fitbit Charge 3 black, and asked to wear it for 1-6 weeks. Participants will monitor their sleep through the sleep section in the Fitbit app on the smartphone. Participants will be provided login information so that researchers can access this data and asked to keep Bluetooth on. After week 6, participants can choose to continue to wear the device for the duration of the study (12 weeks). Though wear at weeks 7-12 is not required, researchers will still use any data that was collected from the fitbit during that time. At the completion of their participation, researchers retain the login information and the device is switched to a personal login of the participants choice.
15824740|NCT04246411|Behavioral|Ultrasound-guided determination of cuffless RAE tube depth|"Measurement of Carina-T2 mid-vertebra length from preoperative Cheat PA
~Ultrasound-guided detection of endobronchial intubation depth by loss of lung sliding sign in the left lung field.
~Withdrawal of the cuffless RAE tube using the Carina-T2 mid-vertebra length for optimal positioning"
15824762|NCT04246203|Other|Liquid Biopsy|17-20 ml of blood will be collected prior of surgery and within 14 days before start of adjuvant chemotherapy.
15824763|NCT04246190|Drug|CKD-501 and D759|Reference drug, CKD-501 1T and D759 1T, QD, PO
15824764|NCT04246190|Drug|CKD-396|Reference drug, CKD-396 1T, QD, PO
15824741|NCT04246411|Behavioral|Auscultation-guided determination of cuffless RAE tube depth|"Measurement of Carina-T2 mid-vertebra length from preoperative Cheat PA
~Auscultation-guided detection of endobronchial intubation depth by loss of breathing sound in the left lung field
~Withdrawal of the cuffless RAE tube using the Carina-T2 mid-vertebra length for optimal positioning"
15824742|NCT04246398|Other|FMT|"Participants will be asked to fast for 4 hours prior to and 1 hour following capsule intake.
~Each capsule will be taken with a sip of water, Capsules must not be crushed, chewed, or dissolved Participants will be evaluated for 15 minutes immediately following capsule administration."
15824743|NCT04246398|Other|FMT - placebo|"Participants will be asked to fast for 4 hours prior to and 1 hour following capsule intake.
~Each capsule will be taken with a sip of water, Capsules must not be crushed, chewed, or dissolved Participants will be evaluated for 15 minutes immediately following capsule administration."
15824744|NCT04246385|Behavioral|CO-OP Group|"Participants in the intervention group will attend one 1:1 session where one goal will be selected from their COPM results to focus on during the group, group expectations will be reviewed, caregivers will be invited, and questions answered. The group will run six sessions as supported by the literature (Chan, 2007; Lee, Fischer, Zera, Robertson, & Hammel 2017).
~Day Rehab CO-OP Group Curriculum Session Content
~Introduction One on one session. COPM, introduction to group, education for caregiver. Session 1 Introduction to group and CO-OP approach, homework. Session 2 Review CO-OP approach, practice, homework. Session 3 Review CO-OP approach, plan outing, homework. Session 4 Review CO-OP approach, experiential learning according to participants' alternate COPM goals, homework. Session 5 Review CO-OP approach, outing, homework. Session 6 Review CO-OP approach, focus group, lessons learned, final COPM, homework"
15824745|NCT04246372|Drug|Tofacitinib|Treatment with oral Tofacitinib for immune mediated skin conditions in adults with Down syndrome
15824746|NCT04246359|Drug|Rituximab Biosimilar|To evaluate the short-term objective efficacy of HLX01 combined with Pegylated Interferon α-2b in patients with advanced idolent B-cell lymphoma.
15824747|NCT04246359|Drug|Pegylated Interferon α-2b|To evaluate the short-term objective efficacy of HLX01 combined with Pegylated Interferon α-2b in patients with advanced idolent B-cell lymphoma.
15824748|NCT04246346|Other|An interactive chatbot for patient decision aid|A chatbot of patient decision aid embedded into a mobile application which is able to bidirectionally interact with patients and provide standard general information, quantitative risk information on the possible outcomes of cataract surgery.
15824749|NCT04246333|Other|Mode of Delivery of Feeds|Eligible infants will be recruited and enrolled and randomized to either duodenal feeds (DF) or gastric feeds (GF), which will occur just prior to the infants advancing beyond 50mL/kg/day of enteral feeds. All enrolled infants will be fed per our institutional feeding protocol. Once infants advance past a volume of 50mL/kg/day of enteral feeds, at this point infants will be randomized to DF or GF groups.
15824750|NCT04246320|Other|Goal directed therapy (GDT)|Goal directed therapy (GDT) hemodynamic management (MAP > 60 mmHg) and processed EEG-guided anesthesia (PSI targeted between 30-50).
15824751|NCT04246307|Diagnostic Test|TEG® and ClotPro® parameters|"Systemic sampling is performed six times:
~before the surgery (S1)
~during the hepatectomy, 10 minutes before the anhepatic phase (S2)
~in the anhepatic phase, before starting portal vein anastomosis: (S3)
~in the neohepatic phase, 15 minutes after releasing portal vein clamping: (S4)
~in the neohepatic phase, at the end of the surgery: (S5)
~Regional sampling from the portal vein representing afferent flow to the liver is performed once:
~• in the anhepatic phase, before starting portal vein anastomosis: (R)
~Simultaneously with haemostasis and blood gas analyses, the following investigations will be performed (the following tests are also routinely performed at the given time points, independently of this study):
~haemodynamic measurements by PiCCO
~arterial blood gas analysis from radial artery catheter
~central venous blood gas analysis from subclavian vein catheter
~blood temperature measurement in the femoral artery by PiCCO catheter
~hourly urinary output"
15824752|NCT04246294|Device|Continuous Positive Airway Pressure (CPAP)|"CPAP is golden standard treatment for moderate-to-severe sleep apnea with high compliance, effectiveness, and cost-effectiveness.
~There will be no interference with standard care."
15824753|NCT04246281|Device|SPRINT Peripheral Nerve Stimulation (PNS) System|The SPRINT System delivers mild electrical stimulation to the nerves in your low back. The SPRINT System includes up to two leads (small wires) that are placed through your skin into your low back. The leads attach to devices worn on your body that deliver stimulation (called Stimulators).
15824754|NCT04246281|Procedure|Standard interventional management of low back pain|Your doctor will determine which procedure or intervention is appropriate for your back pain. You may receive radiofrequency ablation, spinal cord stimulation, surgery, or another procedure or treatment, as appropriate.
15824755|NCT04246268|Device|INVOcell|Female participants undergoing in vitro fertilization (IVF) and/or Intracytoplasmic Sperm Injection (ICSI) for assisted reproduction will be asked to participate.
15824756|NCT04246255|Drug|Xylocaine 10% Oral|"50 ml of lidocaine solution maintained from xylocaine 10% oral that transferred to a bottle with a spray pump which pumps 0,1ml for each pump will be used for the experiment.
~3 pumps of lidocaine will be administrated to 3M TegadermTM +Pad Film Dressing with Non-Adherent Pad and put onto the skin for 10 minutes that IV cannula planned to be inserted."
15824757|NCT04246255|Drug|Placebo- Serum Fizyolojik Izotonik 0,9% 10 ml ampul|"50 ml of Serum physiologic in a bottle with a spray pump which pumps 0,1ml for each pump will be used for placebo.
~3 pumps of placebo will be administrated to 3M TegadermTM +Pad Film Dressing with Non-Adherent Pad and put onto the skin for 10 minutes that IV cannula planned to be inserted."
15824758|NCT04246229|Diagnostic Test|Transcutaneous bilirubinometry|use of transcutaneous bilirubinometry a non-invasieve measurement of skin bilirubin levels
15824759|NCT04246229|Diagnostic Test|Serum bilirubin|use of blood draws to measure serum bilirubin level
15824760|NCT04246216|Procedure|Percutaneous Electrical Nerve Stimulation|Experimental: Percutaneous Electrical Nerve Stimulation The experimental group will receive 3 sessions (once per week) of ultrasound-guided Percutaneous Electrical Nerve Stimulation targeted the median nerve. Once the median nerve is ultrasound identified, the needles will be left in situ at the identified points connected to an electrostimulator (ES-160 ITO co.) applying a biphasic continuous waveform, at low frequency (2 Hz)19 and with 250 microseconds pulse duration for 30mins.
15824761|NCT04246216|Procedure|Endoscopic surgery of the carpal tunnel|The surgical group will receive a surgical procedure consisting of the decompression and release of the median nerve at the carpal tunnel performed by an experienced surgeon according to standardized protocols.
15824770|NCT04246164|Device|HD-tDCS combined with CT|HD-tDCS treatments will be administered during a cognitive training session.
15824771|NCT04246164|Device|sham HD-tDCS combined with CT|sham-HD-tDCS treatments will be administered during a cognitive training session.
15824772|NCT04246151|Drug|Vancomycin|Vancomycin capsules
15824773|NCT04246151|Dietary Supplement|Culturelle|Culturelle capsules
15824774|NCT04246151|Drug|Vancomycin Placebo|sugar pill manufactured to mimic the vancomycin 125 mg capsule
15824775|NCT04246151|Drug|Probiotic Placebo|sugar pill manufactured to mimic 10 billion unit probiotic capsules.
15824776|NCT04246138|Procedure|alignment types|types of alignment mechanical versus kinematic of TKA to be studied
15824777|NCT04246125|Procedure|Interventional radiology : skin dose measurements|"Therapeutic interventional radiology procedure for the following anatomical regions:
~cerebral (neuroradiology)
~thoracic (cardiology, lungs)
~abdominal
~Assessment of peak skin dose and dose mapping with use of Gafchromic film dosimeter and the estimation of the absorbed dose to the skin with use of RDM software program."
15824778|NCT04246112|Other|Handwriting intervention|children will practice handwriting 5 days p/week, 15-20 minutes p/day for 12 weeks using the movalyzer software program.
15824779|NCT04246099|Other|Post-operative care|"Retrospective collection of clinical data recorded in the electronic medical record.
~The following variables were continuously recorded in the institutional database: age, gender, body weight, height, personal medical history, American Society of Anesthesiologists (ASA) score, type of thoracic surgery, the duration of surgery, duration of anesthesia (from intubation to extubation), the duration of PACU stay, the need for morphine titration, epinephrine, norepinephrine.
~For data at day 30, the vast majority of patients were included in the enhanced recovery program and as such benefited from a consultation at 1 month with a coordination nurse who collected data on post-operative pain in a standardized manner.
~All data was extracted from investigators institutional database and collected by a physician who was not involved in the care of the study patients."
15824786|NCT04246060|Drug|Cysteamine Bitartrate|ERT
15824787|NCT04246047|Drug|Belantamab mafodotin|Humanized anti-B-cell maturation antigen (BCMA) antibody/drug conjugate
15824788|NCT04246047|Drug|Daratumumab|Anti-cluster of differentiation 38 [CD-38] monoclonal antibody
15824789|NCT04246047|Drug|Bortezomib|Proteasome Inhibitor
15824790|NCT04246047|Drug|Dexamethasone|Synthetic glucocorticoid with anti-tumor activity
15824791|NCT04246034|Procedure|Microvascular Breast Reconstruction with Vascularized Lymph Node Transfer|simultaneous free abdominal flaps with VLNT from groin are transferred on a single pedicle for breast reconstruction and postmastectomy lymphedema
15824792|NCT04246021|Drug|Ferric carboxymaltose (FCM)|intravenous iron formulation
15824793|NCT04246008|Other|Neuromuscular training|The exercise training was developed based on assuring the correct performance of the exercise focusing in motor control.
15824794|NCT04246008|Other|Conventional strength training|The exercise training was developed based on standard strength training used in cardiac rehabiliation programmes
15824795|NCT04245995|Diagnostic Test|Feature Extraction Technology|The study´s aim was evaluation of the clinical applicability of the Feature Extraction Technology (FET) during a simulated blood loss scenario in comparison to visual estimation.
15824796|NCT04245982|Procedure|Gingival biopsy|Two gingival biopsies from each participant were collected.
15824797|NCT04245969|Device|Experimental: 448 kilohertz Capacitive Resistive Monopolar Radiofrequency stimulus|448kilohertz capacitive resistive monopolar radiofrequency will be applied on the shoulder and thoracic area
15824798|NCT04245969|Other|Sham comparator|A simulation of 448kilohertz capacitive resistive monopolar radiofrequency will be carried out to make believe the patient to be treated through this equipment.
15824799|NCT04245969|Other|No intervention|These participants will be assessed at the same time than the rest of participants. They will not receive any kind of treatment.
15824800|NCT04245956|Procedure|Measure of hemodynamic indices in a stenosed coronary artery using a pressure wire|The intervention consists of measuring a series of hemodynamic indices in a stenosed coronary using a pressure wire, immediately before and after transcatheter mitral valve repair using the percutaneous edge-to-edge MitraClip system in patients with severe mitral insufficiency and concomitant intermediate coronary artery stenosis.
15824801|NCT04245943|Behavioral|Exercise training|18 weeks supervised strength and aerobic exercise training.
15824802|NCT04245930|Procedure|Bovine Pericardial Patch in Immediate Implant Breast Reconstruction|Patients will receive immediate breast implant reconstruction using Bovine Pericardial Patch
15824803|NCT04245930|Procedure|TiLOOP® Bra Mesh in Immediate Implant Breast Reconstruction|Patients will receive immediate breast implant reconstruction using TiLOOP® Bra Mesh
15824804|NCT04245917|Other|Non-interventional|Non-interventional natural history study
15824805|NCT04245878|Other|gastric ultrasound|gastric ultrasound for measurement of the antral area
15824806|NCT04245865|Drug|Fluorouracil|2800 mg/m2 iv
15824807|NCT04245865|Drug|Calcium folinate|400 mg/m2 iv
15824813|NCT04245852|Other|Strength education video|The Strength education video must be watched by the patient at the University of Illinois at Chicago Faculty Practice (UICFP) prior to leaving from the 3rd physical therapy visit. The Experimental Group (EG) will watch the video in the waiting room or other quiet available rooms on the 3rd floor within the UICFP. The video will be watched from an iPad/tablet/laptop/desktop computer device as available in the clinic. The EG will also be provided a handout with a link and quick response code to the video on YouTube.com
15824814|NCT04245852|Other|standard PT care|standard PT care
15824815|NCT04245839|Drug|Fludarabine|Fludarabine
15824816|NCT04245839|Drug|Cyclophosphamide|Cyclophosphamide
15824817|NCT04245839|Drug|JCAR017|JCAR017
15824818|NCT04245826|Other|Change in LCSBs Intake|Effect of changing LCSBs intake
15824819|NCT04245826|Other|Substitute LCSBs for SSBs or Water|Effect of substituting LCSBs for SSBs or Water
15824820|NCT04245813|Behavioral|Interdisciplinary educational program|Interdisciplinary educational component based on the Clinical Practice Guide for Heart Failure
15824821|NCT04245787|Drug|Self assembling peptide with fluoride|peptide forms a 3D matrix within demineralized carious lesions areas, which enables novo hydroxyapatite crystal formation facilitating the so-called guided enamel regeneration of the lost enamel structure. The peptide has shown encouraging results as a scaffold for enamel regeneration
15824822|NCT04245774|Drug|Levobupivacaine (as Levobupivacaine Hydrochloride) 75 Mg/10 mL Solution for Injection Ampoule|7,5 mg (1.5 mL) of 0,5% hyperbaric levobupivacaine (1 mL 0.75% isobaric levobupivacaine (Chirocaine® 75 mg/10mL ampoule Abbott/Turkey, Nycomed Pharma/Norway) plus 0.24 mL 50% Dextrose (dextrose 120 mg) (Eczacıbaşı/Turkey) and 0.26 mL distilled water) injected into the intrathecal space in sitting position through L4-L5 or L5-S1 intervertebral space in 30 seconds. All patients kept in sitting position for 5 minutes with aid after intrathecal injection and than layed in supine position, finally they positioned in prone jack-knife.
15824823|NCT04245774|Drug|Bupivacaine/Dextrose|7,5 mg (1.5 mL) of 0,5% hyperbaric bupivacaine (dextrose content 80 mg/mL) injected into the intrathecal space in sitting position through L4-L5 or L5-S1 intervertebral space in 30 seconds. All patients kept in sitting position for 5 minutes with aid after intrathecal injection and than layed in supine position, finally they positioned in prone jack-knife.
15824824|NCT04245761|Dietary Supplement|Sonidor®|Sonidor® triple layer release tablets are developed with a specialized process to improve stability and bioavailability of the formulation based on hawthorn, lavender and hop extracts. The hawthorn, lavender and hop extracts used to product Sonidor® have an elevated content of vitexin (3%), monoterpens (4% as linalool) and flavonoids (4%), respectively.
15824825|NCT04245748|Drug|Escitalopram|Escitalopram, a SSRI, commercially known as LexaproTM, is commonly prescribed for anxiety disorders and is FDA-approved for acute and maintenance treatment of MDD and GAD.
15824826|NCT04245748|Drug|Duloxetine|Duloxetine, a SNRI, commercially known as CymbaltaTM, is FDA-approved for the treatment of GAD, MDD, diabetic peripheral neuropathic pain, fibromyalgia, and chronic musculoskeletal pain in adults.
15824827|NCT04245735|Diagnostic Test|perfusion index|To test the objective role of perfusion index in assessing the success of the peripheral nerve block in children under sedation.
15824828|NCT04245722|Drug|FT596|Experimental Interventional Therapy
15824829|NCT04245722|Drug|Cyclophosphamide|Lympho-conditioning agent
15824830|NCT04245722|Drug|Fludarabine|Lympho-conditioning agent
15824831|NCT04245722|Drug|Rituximab|Monoclonal Antibody
15824832|NCT04245722|Drug|Obinutuzumab|Monoclonal Antibody
15824833|NCT04245709|Drug|Clenbuterol|The intervention is treatment with oral clenbuterol at 40-80 micrograms twice daily for 24 weeks. Dosage will initially be 40 mcg daily for one week, then 40 mcg BID per oral daily for the next 5 weeks. If the 40 mcg BID per oral is well tolerated in the opinion of Dr. Bedlack, the dose will be increased to 80 mcg each morning/40 mcg each evening for one week, followed by 80 mcg BID per oral for the remainder of the study. The selected target dose (80 mcg BID) is based upon the experience with the long-term administration of clenbuterol, specifically the beneficial muscle effects in a Phase I/II clinical trial that enrolled patients with late-onset Pompe disease who were previously treated with ERT (Koeberl et al. 2018).
15824834|NCT04245696|Device|Dermal Handpiece / SubQ Handpiece|Bipolar radiofrequency (RF) travels from the RF generator, through the electrodes and into the dermal layers beneath the surface of the skin. The microneedles of the Dermal and SubQ cartridges coupled with thermal heat will stimulate neocollagenesis and neoelastosis, aiding in the reduction of submental laxity.
15824835|NCT04245683|Procedure|Bowel/rectal resection|surgical removal of the portion of the rectum where the tumor was originally identified
15824836|NCT04245683|Other|non-operative follow up|patients who choose the non-operative option will be required to adhere to a very intensive follow up protocol, including endoscopy and CT imaging
15824837|NCT04245670|Radiation|Stereotactic Ablative Body Radiotherapy (SABR) 35-50 Gy/5|Stereotactic Ablative Body Radiotherapy (SABR) given in 5 weekly fractions. Simultaneously treating the pelvic lymph nodes, prostate and MRI-nodule to a total dose of 25 Gy, 35 Gy and up to 50 Gy, respectively. The radiation will be given with 6-18 months of ADT.
15824838|NCT04245657|Other|Tissue Dielectric Constant Measurement|Sub-tissue fluid proportion will be evaluated via Moisture Meter D (Delfin Technologies, Kuopio, Finland) on both upper extremity (right and left) in predefined reference points on volar side (6 cm distal and 8 cm proximal points from cubital crease, 10 cm inferior side point from axilla and dorsal point of web space in the hand) by using four different probes which can assess 0.5 mm, 1.5 mm, 2.5 mm and 5.0 mm depth. Values taken by 2.5 mm depth probe will be used to calculate the ratio (affected side TDC value/Unaffected side TDC value) to stage lymphedema severity along with the International Society of Lymphology staging system. This device mainly aims to assess the dielectric constant of tissues which is related to the amount of tissue water. In the case of pre-lymphedema or lymphedema, one can assess objectively regarding sub-tissue fluid changes via this device. Triplicate measurements will be taken for each reference point.
15824839|NCT04245657|Other|Muscle strength measurement|Participants' muscle strength of shoulder flexion, abduction, and elbow flexion will be assessed via Handheld digital dynamometer (Lafayette Manual Muscle Tester, Model 01165, LaFayette Instruments, NY, USA). Both upper extremities will be assessed three times and the average value will be recorded.
15824897|NCT04245176|Behavioral|Quantitative Genetic Counseling|Quantitative genetic counseling: Discussion is guided by tables and graphs.
15824840|NCT04245657|Other|Hand-Grip Strength Measurement|Handgrip strength will be assessed with LaFayette Professional Hand Dynamometer, Model 5030L1, LaFayette Instruments, NY, USA). The standard position which can be achieved by 90-degree elbow flexion, shoulder abducted, and hand mid-prone positioned; 90-degree shoulder abduction and 90-degree shoulder abduction positions will be used to assess hang-grip strength. Three measurements will be requested and the maximum value of them will be recorded. 1 minute resting period will be provided between the positions at which handgrip is assessed.
15824841|NCT04245657|Other|Pain Threshold Measurement|The sensitive pain threshold and normal pain threshold will be evaluated by a digital algometer (Wagner FDIX, Greenwich, USA) on reference points as follows: C5-C6 zygapophyseal joints' lateral points, upper trapezius (proximal, middle and distal lateral points, length measured by a tape from C7 Processus spinosus to acromion and this length will be divided equally into three parts for proximal, middle and distal lateral point), deltoid muscle (crista deltoidea), dorsum of the webspace.
15824842|NCT04245657|Other|International Physical Activity Questionnaire-Short Form (IPAQ-SF)|This scale was intended to be filled to assess participants' physical activity levels within the last seven days. Then, MET calculations will be done via a basic Excel Spreadsheet which is pre-defined MET values formulated inside. Scale data then obtained according to the participants' answers and recorded.
15824843|NCT04245657|Other|Fatigue Impact Scale|"This scale has 9 items that can be answered as Strongly Disagree through Strongly Agree by numbered as 1 and 7, respectively. Then total points will be calculated and divided into 9 to achieve the Fatigue Impact Scale score. The higher points will be indicated more perceived fatigue, while lower points indicate less."
15824844|NCT04245657|Other|Disabilities of Arm, Shoulder and Hand Scale (DASH)|"DASH has 30 items related to upper extremity function. Participants will be requested to grade some expressions related to the function within a 5-point Likert scale as follows: No difficulty: 1, Mild Difficulty:2, Moderate Difficulty: 3, Severe Difficulty: 4 and Unable to perform: 5). The symptom score of the DASH will be calculated as dividing filled items total score to filled items' number and minus one from this data then multiplying with 25. The higher points indicate a deteriorated shoulder and hand function while lower points indicate a better upper extremity function."
15824845|NCT04245657|Other|Exercise Benefits/ Barriers Scale|Exercise Benefits/Barriers Scale has 43 items each can be graded within a four-point Likert type scale. Barrier items are reverse coded. 43 items are all related to exercise and exercise beliefs in both in the aspect of health and general. Strongly disagree, disagree, agree, strongly agree will be scored as 1,2,3,4 or vice versa whether the item should de reversely coded, respectively. Total scores ranged between 29 and 172. The barrier scale score is ranged between 14 and 56. The benefits scale is also ranged between 29 and 116. The higher the score of Barriers scale, the greater the perception of barriers to exercise.
15824846|NCT04245657|Other|Beck Depression Scale|Beck Depression Scale has 21 items each can be scored within 0 to 3. All items are related to the depressive mood of a participant. The higher the score of the Beck Depression Scale, the higher the depression level.
15824847|NCT04245644|Behavioral|use of targeted drugs such as aspirin, B-Blockers, Metformin, ACE-inhibitors, Statins|enrolled patients will be asked details regarding their daily drug use, before and after diagnosis of pancreatic cancer
15824848|NCT04245631|Diagnostic Test|Recombinase aided amplification (RAA) assay|We established a real time reverse-transcription RAA (RT-RAA) assay for detection of 2019-nCoV. This assay was performed at 42°C within 30min using a portable real-time fluorescence detector, Recombinant plasmids containing conserved ORF1ab genes was used to analyze the specificity and sensitivity. Clinical specimens from patients who were suspected of being infected with 2019-nCoV were used to evaluate the performance of the assay. In parallel, we also used the commercial RT-qPCR assay kit for 2019-nCoV as a reference. Sample types include either of nasal swab, oral swab, bronchoalveolar-lavage fluid, urea, blood, fecal.
15824849|NCT04245618|Drug|neoadjuvant chemotherapy ( cisplatin - gemcitabine)|Neoadjuvant chemotherapy before TURBT
15824850|NCT04245605|Procedure|Coronary angiography|Coronary angiogram performed either in hospital or post-discharge, within 14 days after initial hospital presentation with heart failure
15824851|NCT04245592|Dietary Supplement|Extra Virgin Olive Oil|Before beginning the 3-week dietary trial, participants will conduct a 2-week washout period during which they consumed ROO (50 ml daily for 2 weeks) because they are part of a population that consumes olive oil regularly. After thar, patients of this groups will consume 50 ml/day of organic EVOO for 3 weeks. Biochemical markers and clinical parameters in each participant will be determine before and after the 3-week treatment period.
15824852|NCT04245592|Dietary Supplement|Refined Olive Oil|Before beginning the 3-week dietary trial, participants will conduct a 2-week washout period during which they consumed ROO (50 ml daily for 2 weeks) because they are part of a population that consumes olive oil regularly. After thar, patients of this groups will consume 50 ml/day of ROO for 3 weeks. Biochemical markers and clinical parameters in each participant will be determine before and after the 3-week treatment period.
15824853|NCT04245579|Other|Multifactorial Memory Training Program (UMAM method)|
15824854|NCT04245566|Procedure|Prostatic Artery Embolization (PAE)|Prostatic artery embolization will be performed under local anesthesia according to well established and standardized techniques.
15824855|NCT04245566|Drug|Pharmacotherapy|Pharmacotherapy will be performed using α1-blockers and 5α-reductase inhibitors in accordance with the EAU recommendations
15824856|NCT04245553|Diagnostic Test|Abdominal Point of Care Ultrasound|Participants will be have their needle insertion site for a paracentesis land-marked using both the traditional anatomical method, and with a point of care ultrasound. Note that the current standard of care does not require the use of point of care ultrasound.
15824857|NCT04245540|Dietary Supplement|Pau d' Arco|Encapsulated herbal Pau d' Arco.
15824858|NCT04245527|Device|Joovv Infrared Light Device|Joovv is the leading manufacturer of personal, in-home red light therapy devices
15824859|NCT04245514|Drug|Durvalumab|Immunotherapy
15824860|NCT04245514|Radiation|Radiotherapy|Immune-modulatory radiotherapy to the primary tumor, with either Cohort A: 20 x 2 Gy weekdaily Cohort B: 5 x 5 Gy weekdaily Cohort C: 3 x 8 Gy q2d
15824861|NCT04245501|Other|Cognitive Bias Modification for Interpretations (CBM-I)|Computerized intervention in which youth see word-sentence pairs personalized to their anxiety symptoms, and indicate whether these are related. Youth receive feedback aimed to reduce interpretation bias.
15824992|NCT04244331|Diagnostic Test|CCO|Determination of COO in tumor biopsies from patients with GBDD using the Lymph2Cx assay using NanoString tectology
15824862|NCT04245501|Other|Interpretation Control Condition (ICC)|"Computerized control condition in which youth see word-sentence pairs personalized to their anxiety symptoms. Youth indicate whether these are related, but are not provided with feedback that aims to train a reduction in interpretation bias."
15824863|NCT04245488|Other|taste test|rate intensity of sour solutions and fatty acid solutions
15824865|NCT04245462|Other|No intervention|Cross-sectional
15824866|NCT04245449|Behavioral|TEAACH|"TEAACH e-learning: 3-months of online educational modules include neuroscience education (based on an effective pain educational model37) to improve patient self-efficacy, and strategy-training38 to improve patients' problem-solving abilities for at-home arm use. The course is live on the MUSC MoodleCE platform.
~TEAACH in-clinic therapy: 24 in-clinic sessions; 3 times/week for 4 weeks (month 1), 2 times/week for 4 weeks (month 2) and 1 time/week for 4 weeks (month 3) with 200 movement repetitions per session. In our RCTs, this therapy dose required ~1.0-1.5 hours/session. A critical element of TEAACH is the focus on linking in-clinic therapy to out-of-clinic real world paretic arm use via MoodleCE Learning Activities."
15824867|NCT04245436|Drug|Duloxetine|Encapsulated duloxetine 30 mg, 60 mg; once-daily
15824868|NCT04245436|Drug|Escitalopram|Encapsulated escitalopram 5 mg, 10 mg, 15 mg, 20 mg; once-daily
15824869|NCT04245423|Behavioral|Collaborative Care for Opioid Use Disorders and Mental Health Conditions|CC is delivered using the investigators' Foundations for Integrated Care model. The first line pharmacotherapy is buprenorphine-naloxone. The second line pharmacotherapy included is extended-release injectable naltrexone. Pharmacotherapy is accompanied by brief problem-solving therapy, cognitive-behavioral therapy, and/or motivational interviewing. The primary care physician, in consultation with the addictions psychiatrist and care manager, also will provide psychotropic medications for psychiatric disorders. In-person and telephone visits consist of the care manager carrying out intervention activities over 6 months. Visits are at baseline (90-minute intake appointment), home or office induction when in moderate opiate withdrawal if buprenorphine is prescribed, twice a week for two weeks with telephone calls in between visits, then weekly, and when stable once a month. There will be a final visit at 6 months. The intervention includes routine collection of urine drug screens.
15824870|NCT04245423|Behavioral|Augmented Usual Care|If not already waivered, PCPs will be trained and waivered to treat OUD with medications. All practices will have mental health clinicians to treat mild psychiatric disorders. Other than that, the research team will provide no support to the PCP or practice staff. However, an addiction psychiatrist is available for consultation for OUD.
15824871|NCT04245423|Behavioral|Collaborative Care for Opioid Use Disorders and Mental Health Conditions Plus Certified Recovery Specialists|This intervention includes the Collaborative Care Intervention plus Certified Recovery Specialist to assist with treatment engagement and retention.
15824872|NCT04245397|Drug|SX-682|Drug: SX-682 SX-682 is an oral small molecule selective inhibitor of C-X-C Motif Chemokine Receptor 1 (CXCR1) and CX-C Motif Chemokine Receptor 2 (CXCR2)
15824873|NCT04245384|Other|Internet-based dietetic treatment with video calls|The dietitian meets the patient through video calls, no physical meetings
15824874|NCT04245384|Other|Traditional dietetic treatment|The dietitian meets the patient through physical meetings
15824875|NCT04245371|Drug|Lidocaine 1.8%|Topical Patch
15824876|NCT04245371|Drug|Placebo|Matching Placebo Patch
15824877|NCT04245358|Device|Ainara|1g of gel per administration
15824879|NCT04245332|Dietary Supplement|Fish oil|Fish oil-derived omega-3 polyunsaturated fatty acids (4g fish oil concentrate: 2g EPA+ 1g DHA)
15824880|NCT04245332|Dietary Supplement|Coconut oil|Coconut oil (4g/d)
15824881|NCT04245319|Drug|Acitretin|The patients will receive the drug and the effect on repigmentation on vitiligo lesions will be observed
15824882|NCT04245319|Other|Narrow band ultraviolet B|Patients receive nbUVB session 3 times per week
15824883|NCT04245306|Other|computerized test for pragmatic inferences|Computerized tests
15824884|NCT04245293|Device|Ainara|Each administration kit (subject kit) for patients of Ainara® will contain a box with 1 tube with 30 g gel, 1 cannula and 1 plunger. The gel quantity is enough for one subject over the course of the study (1 g at each administration).
15824885|NCT04245293|Device|HyaloGin|"Active Comparator: HyaloGin Each administration kit (subject kit) for patients allocated to HyaloGyn® group will contain a box with: 1 tube with 30g gel and 10 single-use applicators consisting of a piston and one opaque plastic plunger.
~The gel quantity is enough for one subject (3g application every three days over the course of the study)."
15824886|NCT04245280|Drug|Ropivacaine 0.5% Injectable Solution|ropivacaine 0.5% with epinephrine 2.5 mcg/ml
15824887|NCT04245280|Drug|Saline Solution|normal saline solution (NaCl 0.9%)
15824888|NCT04245267|Behavioral|DIABEMPIC|Patients are attended by 9 diabetes health-care professionals every 2 weeks for 5 months in a shared medical appointment scheme, including individual and group sessions. Patients will be evaluated at the end of the program and 1 year after.
15824889|NCT04245254|Dietary Supplement|Collagen Protien Powder|Collegen Protein Powser
15824890|NCT04245241|Other|High-flow nasal cannula (HFNC)|24 patients who receiving HFNC within 24 hours after extubation were prospectively enrolled in this study. EIT was used to monitor regional lung ventilation distributions at baseline (conventional oxygen therapy) and three flow rate levels of HFNC therapy (20, 40 and 60 L/min).
15824892|NCT04245215|Drug|Ustekinumab|re-induction and dose escalation form every 8 weeks to every 4 weeks only in arm 2
15824893|NCT04245202|Device|HFNCOT|The patient will receive a high flow nasal of humidified oxygen, set between 2 to 25 l/min. The inspired fraction of oxygen (FiO2) will be adjusted to obtain the oxygen saturation >92%.
15824894|NCT04245202|Other|St-FMOT|The inspired fraction of oxygen (FiO2) will be adjusted to obtain the oxygen saturation >92%.
15824895|NCT04245189|Other|Endoscopic ultrasound for detection of Chronic pancreatitis|Presence of Chronic pancreatitis in alcoholic cirrhosis patients.
15824896|NCT04245176|Behavioral|Standard Genetic Counseling|Standard genetic counseling: Standard of care discussion
15824898|NCT04245163|Behavioral|Educational program|The intervention program will include 3 phases. At phase 1 a presentation on Microsoft PowerPoint in order to increase the general knowledge about glaucoma. At phase 2 a video and a one on one teaching to develop skills of administering the eye drops in a correct and systematic way. At phase 3, a discussion in order to identify cues to action that can easily be adopted by the patient in his/her daily routine, (such as, how to remember to put in drops) will take place.
15824901|NCT04245124|Other|Strategic Memory Advanced Reasoning Training|SMART focuses on three metacognitive strategies: Strategic Attention, Integrated Reasoning and Innovation.
15824902|NCT04245124|Other|Traditional Cognitive Rehabilitation|Participants randomized to the TCR condition will participate in a clinician-directed intervention that provides manualized, traditional clinician-directed cognitive rehabilitation that was developed for the SCORE trial (Cooper et al., 2017)
15824903|NCT04245111|Other|Immunofluorescence Imaging|Patients will be administered FDA approved ICG through intravenous injection and imaged by a FDA approved surgical microscope (Pentero or Spy Elite) which is 0.5 meter away from the subject. Both ICG fluorescence and the two imaging systems have been used for routine clinical practice for many years. Figure (a) shows the Schematic sketch of the imaging systems. ICG fluorescence imaging utilizes intravenously injected ICG, which is a fluorescent dye that is FDA-approved for clinical use, illuminated with near-infrared light. The ICG dye is indirectly activated and the dynamic fluorescence due to bone perfusion can be captured by a video rate imaging system.
15824904|NCT04245098|Procedure|Carpal tunnel syndrome surgery|Biopsy
15824905|NCT04245085|Drug|Atezolizumab|"Patients in both treatment arms will receive atezolizumab at a fixed dose of 1200 mg i.v. on day one of every 3-week (3 days) cycle, until progression of disease determined according to RECIST v1.1 or lack of tolerability, or patient declines further treatment.
~Treatment beyond RECIST-defined progression will be allowed if patient is continuing to derive clinical benefit."
15824906|NCT04245085|Drug|Bevacizumab|Patients in both treatment arms will receive bevacizumab at a dose of 15 mg/kg i.v. on day one of every 3-week (+/- 3 days) cycle, until progression of disease determined according to RECIST v1.1 or lack of tolerability, or patient declines further treatment.
15824907|NCT04245085|Drug|Carboplatin|Patients in treatment Arm A will receive carboplatin, AUC5 every 3 weeks for 4-6 cycles.
15824908|NCT04245085|Drug|Paclitaxel|Patients in treatment Arm A will receive paclitaxel, 175-200 mg/m2 (at the investigators' discretion), every 3 weeks for 4-6 cycles.
15824909|NCT04245085|Drug|Pemetrexed|Patients in treatment Arm B will receive Pemetrexed, 500 mg/m2 every 3 weeks until progression of disease determined according to RECIST v1.1 or lack of tolerability, or patient declines further treatment.
15824910|NCT04245072|Procedure|Intravitreal injection|Intravitreal injection of Aflibercept 2 mg (0.05 ml) or Ranibizumab 0.5 mg (0.05 ml) to the regimen pro re nata.
15824911|NCT04245072|Diagnostic Test|Fluorescent angiography|Ophthalmic examination
15824912|NCT04245072|Diagnostic Test|Visometry|Ophthalmic examination
15824913|NCT04245072|Diagnostic Test|Refractometry|Ophthalmic examination
15824914|NCT04245072|Diagnostic Test|Slit lamp examination|Ophthalmic examination
15824915|NCT04245072|Diagnostic Test|Ophthalmoscopy|Ophthalmic examination
15824916|NCT04245072|Diagnostic Test|OKT|Ophthalmic examination
15824917|NCT04245059|Device|Multi-channel Transcranial direct current stimulation|A commercial tDCS device will be use in this study. The device is a wireless multi-channel transcranial direct current stimulator that incorporates an 8-channel headcap for stimulation through gel electrodes or classic sponge electrodes. The device is integrated with a user interface for the configuration and monitoring of the stimulus parameters and a fast multifocal simulation of the tDCS electric field using an advanced brain model
15824918|NCT04245046|Drug|Candesartan, Amlodipine, Atorvastatin|compare the pharmacokinetic of candesartan cilexetil, atorvastatin as atorvastatin calcium trihydrate, amlodipine as amlodipine besilate from reference products given as a multiple dose
15824919|NCT04245033|Drug|Dihydroartemisinin-Piperaquine (DP)|Dihydroartemisinin-Piperaquine (DP) for intermittent preventive treatment of malaria in school children (IPTsc).
15824920|NCT04245020|Other|Text message follow up|A text message will be sent to the patient 6-8 weeks following discharge
15824921|NCT04245020|Other|Telephone follow up|The patient will be followed up at 6-8 weeks following discharge with a telephone call
15824922|NCT04245020|Other|In person follow up|The patient will be followed up at 6-8 weeks following discharge in person in the outpatient department
15824923|NCT04245007|Behavioral|Fasting|Doing fasting 2 days a week within 8 weeks
15824924|NCT04244994|Device|Aptima-Combo2 and Aptima Mgen|Self-taken penile meatal swabs versus first-catch urine samples for the detection of Chlamydia trachomatis, Neisseria gonorrhoeae and Mycoplasma genitalium using Aptima-Combo2 and Aptima Mgen
15824925|NCT04244981|Drug|Prothrombin Complex Concentrate, Human|A 4-factor prothrombin complex concentrate (Confidex®, CSL Behring, Marburg, Germany), containing a defined concentration of the four vitamin K-dependent clotting factors (II, VII, IX and X) and the thrombo-inhibitor proteins C and S. Each vial of Confidex® contains a relatively high concentration of coagulation factor II (20-48 IU/mL), factor VII (10-25 IU/mL), factor IX (20-31 IU/mL), factor X (22-60 IU/mL), proteins C (15-45 IU/mL), proteins S (13-38 IU/mL), Heparin (0.5 IU/mL), and antithrombin (0.6 IU/mL). The administration is based on the patients' body weight and INR (INR 2-4, PCC 25 IU/kg; INR 4-6, PCC 35 IU/kg; INR>6, PCC 50 IU/kg)
15824926|NCT04244981|Drug|Fresh Frozen Plasma|FFP will be given based on the patients' body weight (10-15 mL/kg).
15824927|NCT04244955|Other|Semi-directive interviews|The interviews, carried out by the child psychiatrist, will be semi-directive and short (15 to 30 minutes) one-on-one with the child or adolescent so that the presence of the parents does not influence the responses. The CPTS-RI index, which has 20 questions, will be filled, as well as other questions to understand what is problematic for the child.
15824928|NCT04244942|Device|CERAMENT BVF|CERAMENT BONE VOID FILLER is a synthetic biphasic bone graft substitute.
15824929|NCT04244929|Procedure|Total knee arthroplasty|Total knee arthroplasty using standard anterior approach.
15824930|NCT04244929|Device|Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament retaining|Patients will be implanted with this medial pivoting knee prosthesis. Posterior Cruciate Ligament will be retained
15824931|NCT04244929|Device|Persona Medial Congruent Knee Prosthesis implantation with Posterior Cruciate Ligament sacrifice|Patients will be implanted with this medial pivoting knee prosthesis. Posterior Cruciate Ligament will be sacrificed
15824932|NCT04244916|Biological|AUC of MPA measure|"Plasmatic AUC determination of MPA requires 3 blood punctures at H0, H30 and H2.
~These punctures will be made at inclusion after 6 weeks, 12 weeks, 6 months and one year."
15824933|NCT04244890|Device|Uninterrupted CPAP for the first hours of life|Directly at birth the infant will be supported with PPV with PEEP as needed, followed by nasal CPAP. Support will be provided with a single device for up to four hours.
15824934|NCT04244877|Drug|Rifaximin|Drug: Rifaximin tablet
15824935|NCT04244864|Behavioral|Cross-sectoral psychosocial intervention|The intervention seeks to integrate working with social stressors alongside treatment for trauma-related mental health problems. This is done in two ways; by a cross-sectoral collaboration with the patient's case counsellor in the municipality including three collaborative meetings and by a systematic focus on social stressors during the treatment.
15824936|NCT04244864|Behavioral|Treatment as usual (TAU)|"Medical doctor, 10 sessions: Pharmacological treatment according to standard algorithm and psychoeducation.
~Psychologist 16-21 sessions: Manual-based cognitive behavioural therapy."
15824937|NCT04244851|Other|Malnourished patients|"Data of included patients will be recorded during hospitalization using medical charts.
~Every patient will be contacted by phone 3 months after hospital discharge. A sample of patients and their caregivers will be interviewed to better understand their perception of malnutrition and what they need to better take care of malnutrition."
15824938|NCT04244838|Diagnostic Test|Gait Analysis|The patients will undergo Gait analysis (integrated movement analysis system) performed at the Complex Laboratory for Movement Analysis and functional-clinical evaluation of the prosthesis of the Rizzoli Orthopedic Institute. The instrumentation used in the Movement Analysis Laboratory consists of a stereophotogrammetric system equipped with eight infrared cameras (Vicon® 460-Oxford system) and 2 dynamometric platforms (Kistler® Instrument, AG Switzerland). The IOR GAIT protocol will be used as a marker set (Leardini et al. 2007). For the evaluation of muscle activation, surface electromyography with 16-channel system will be used (ZeroWire Cometa, Milan). Spatio-temporal parameters, kinematics, kinetics and muscle activation will be evaluated.
15824939|NCT04244825|Drug|BLD-2660|BLD-2660 - 150 mg capsules '00' size (PO) BID
15824940|NCT04244825|Drug|Control: Placebo|Placebo - 150 mg capsules '00' size (PO) BID
15824941|NCT04244812|Other|Moxibustion|"Two sessions of moxibustion will be performed in the Heart meridian and Lung meridian successively.
~Intervention in the Heart meridian: moxibustion will be performed above Shaohai (HT3) for 15 minutes. During moxibustion, the probes of laser doppler flowmetry will detect the microcirculatory characteristics of three measuring sites, which include the midpoint of the Heart meridian along the left forearm, Chize (LU5) of the Lung meridian, and the midpoint of the Lung meridian along the left forearm.
~Intervention in the Lung meridian: moxibustion will be performed above Chize (LU5) for 15 minutes. During moxibustion, the probes of laser doppler flowmetry will detect the microcirculatory characteristics of three measuring sites, which include the midpoint of the Lung meridian along the left forearm, Shaohai (HT3) of the Heart meridian, and the midpoint of the Heart meridian along the left forearm."
15824942|NCT04244812|Device|Laser doppler flowmetry|Laser doppler flowmetry will be used to detect the microcirculatory characteristics of meridian phenomena
15824943|NCT04244799|Behavioral|Behavioral nudges|"Behavioral nudges include the following:
~Colorful pathway overlaid with footprints leading from the toilet to the handwashing station
~Rotating posters in toilet areas with messages targeting behavioral motivators for handwashing (disgust, social affiliation)
~Sticker of a pair of eyes placed above the handwashing station
~Soap dish with an arrow beside it on the sink or counter to remind children to wash their hands with soap"
15824944|NCT04244799|Behavioral|National WASH policy|"The Philippines' Department of Education National WASH in Schools (WinS) policy promotes correct hygiene and sanitation practices among school children and a clean environment in and around schools and includes initiatives related to infrastructure, knowledge, and behavior change, but does not include other programs with an explicit focus on handwashing promotion."
15824945|NCT04244786|Device|Transcranial direct current stimulation|tDCS is a low-cost, portable, well-tolerated, non-invasive form of brain stimulation that delivers a low current to a specific area of the brain via electrodes.
15824946|NCT04244773|Other|ENDS (vaporizer/e-cig) and smoking cessation counseling|Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit.
15824947|NCT04244773|Other|Smoking cessation counseling|Participants in the control group will receive smoking cessation counseling only. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit.
15824948|NCT04244760|Behavioral|Pain assessment for verbal patients|The pain profile of the patient will be assessed at each time point including biological sample analysis (blood and saliva), quantitative sensory testing (mechanical and thermal), and psychological state via the completion of questionnaires by the patient.
15824949|NCT04244760|Behavioral|Pain assessment for non-verbal patients|The pain profile of the patient will be assessed at each time point including biological sample analysis (blood and saliva), quantitative sensory testing (mechanical), and psychological state via the completion of questionnaires by the parent of the patient.
15824950|NCT04244747|Device|induction of labor by breast stimulation|
15824951|NCT04244747|Device|induction of labor by catheter balloon|
15824990|NCT04244370|Device|Caterpillar™ Arterial Embolization Device|Placement of the Caterpillar™ Arterial Embolization Device for patients requiring arterial embolization in the peripheral vasculature.
15824991|NCT04244344|Other|fall prevention measures|High fall risk signage, information sheet, High fall risk bracelet, verbal instructions
15824952|NCT04244734|Other|Usual care treatment|"All evaluations are the same in both groups:
~Baseline evaluation
~ICU admission (If patient hemodynamically stable initiates physiotherapy treatment within the first 15 days after surgery).
~Treatment:A daily session from Monday to Friday of 40 minutes according to patient functional status: Passive or active-assisted or active mobilizations, muscle enhancement, respiratory physiotherapy and inspiratory muscle training at 40% of the PIM value.
~2nd evaluation when patient has a RASS -1/0 score: 3rd evaluation when ICU discharge.
~Treatment ward: A 60-minute daily session according to patient functional status in the gym (physiotherapy area in hospital): Cycloergometer, muscle enhancement, respiratory physiotherapy and inspiratory muscle training.
~4th evaluation when hospital discharge 5th evaluation (1 month after discharge) 6th evaluation (4 months after discharge) 7th evaluation (1 year after surgery)"
15824953|NCT04244734|Other|New Treatment Protocol-MotoMED®|"Baseline evaluation
~ICU admission (If patient hemodynamically stable initiates physiotherapy treatment within the first 15 days after surgery).
~Treatment: A daily session from Monday to Friday of 40 minutes (5 minutes of warm-up, 30 of training and 5 of cooling). Combined quadriceps / biceps femoris electrotherapy: at 200-350μs intensity. Respiratory physiotherapy with the objectives: Airway permeabilization and inspiratory muscle training at 60% of the PIM value.
~2nd evaluation when patient has a RASS -1/0 score: 3rd evaluation when ICU discharge.
~Treatment ward: A 60-minute daily session according to patient functional status in the gym (physiotherapy area in hospital): Cycloergometer, muscle enhancement, respiratory physiotherapy and inspiratory muscle training.
~4th evaluation when hospital discharge 5th evaluation (1 month after discharge) 6th evaluation (4 months after discharge) 7th evaluation (1 year after surgery)"
15824954|NCT04244721|Other|Preschool Autism Communication Therapy (PACT)|Professionals guide parents in the PACT therapy by videoconference. Sessions between parent and professionals are every 15 days for 6 months. Each session lasts one hour. At the end of the 12 sessions, additional booster sessions (one session per month over 6 months) will allow parents to maintain their skills. Parents will use therapy with their children in daily home practice. The aims of PACT therapy is to improve synchrony in the communication between the child and the parents. Improvement of the synchrony will mediate the decrease of autism symptoms of the child.
15824955|NCT04244721|Other|Treatment As Usual (TAU)|Children will receive therapies available in the community as speech language therapist or occupational therapist.
15824956|NCT04244708|Drug|Radiotherapy plus temozolomide|undergoing fractionated radiotherapy at a dose of 2 Gy per fraction given once daily five days per week (Monday through Friday) over a period of six weeks, for a total dose of 54 Gy, plus continuous daily temozolomide (75 mg per square meter of body-surface area per day, 7 days per week from the first to the last day of radiotherapy), followed by six cycles of adjuvant temozolomide (150 to 200 mg per square meter for 5 days during each 28-day cycle).
15824957|NCT04244708|Other|Radiotherapy plus placebo|undergoing fractionated radiotherapy at a dose of 2 Gy per fraction given once daily five days per week (Monday through Friday) over a period of six weeks, for a total dose of 54 Gy, plus placebo
15824958|NCT04244695|Drug|Dexamethasone Oral|To compare oral dexamethasone 16 mg vs 8 mg vs placebo in pateints undergoing unilateral TKA
15824959|NCT04244682|Device|Repetitive transcranial magnetic stimulation (rTMS)|In the rTMS procedure a small plastic coil will be placed next to the participant's head. The position of the coil will be guided by neuro-navigational software utilizing the individual's MRI scan. The coil will be placed over the relevant brain region using the Brainsight TMS-MRI co-registration system for visualizing the coil position with respect to the participant's individual MRI scan. The coil will then generate a series of repetitive magnetic pulses, and stimulation will occur, disrupting typical function of the targeted brain region.
15824960|NCT04244669|Device|IPG with Conventional Stimulation|In this group, a conventional stimulation with low frequency will be tried. It will be programmed according to the usual clinical practice looking for one or more combinations of poles that allow a coverage of paraesthesia with a conventional stimulation of at least 80% of the painful area. This programming will be modified until getting not only 80% coverage but also a decrease of at least 50% in that area. It can be reprogrammed as many times as necessary during the 14-21 days of margin.
15824961|NCT04244669|Device|IPG with SCS DTM|In this group the SCS DTM™ workflow will be programmed. Each SCS DTM™ program group has at least two programs with different pulse rate in the 20 to 1,200 Hz range and each having a maximum pulse width of 1ms
15824962|NCT04244656|Biological|CTX120|CTX120 B-cell maturation antigen (BCMA)-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components.
15824963|NCT04244643|Other|data collection|"Data collected from patient records
~Demographic data: date of birth, sex, city of birth
~Contact lenses: laboratory, brand, model, wearing time before the exam, opening date of the blister, solution of contact lenses, material, renewal time
~Refraction
~Dry eye disease: Ocular Surface Disease Index (OSDI) score
~LACRYDIAG data: Non-Invasive Break-Up Time (NIBUT), interferometry and tears meniscus height"
15824964|NCT04244630|Combination Product|Antioxidants|Over-the-counter anti-oxidants, namley CoQ10, vitamin E, NAc cysteine, and L-cystine at defined doses
15824965|NCT04244617|Behavioral|iCBT with addition of peer-support|Peer-supporters and participants, as well as psychologists and participants, interact in the treatment program via asynchronous secure messages. Peer-supporters are able to give support and feedback on exercises. A reconciliation call via telephone is entered into the middle of the treatment and a follow-up call after completion of treatment conducted by the peer-support. The interaction between peer-supporters and participants is tracked by the psychologist.
15824966|NCT04244604|Other|Acute Salt (sodium chloride)|Varied amounts of salt (sodium chloride) will be added to a very low sodium soup to determine the effects of a single high sodium meal on measures of vascular function and autonomic regulation of blood pressure
15824967|NCT04244591|Drug|methylprednisolone therapy|Methylprednisolone 40 mg q12h for 5 days
15824968|NCT04244591|Other|Standard care|Standard care
15824969|NCT04244578|Device|Active tDCS|Active tDCS will be delivered to parieto-occipital areas for five consecutive days. tDCS will be delivered by a battery driven, direct current stimulator through a pair of saline-soaked sponge electrodes kept firm by elastic bands. The electrodes will be placed on the left (anodal) and right (cathodal) parieto-occipital areas, PO7 and PO8 position according to the 10-20 international EEG system for electrode placement. Stimulation intensity will be set at 1 milliampere (mA), the duration of stimulation will be 20 min.
15825241|NCT04242368|Drug|Fluticasone Propionate|Fluticasone nasal spray administered two sprays to each nare twice a day
15824970|NCT04244578|Device|Sham tDCS|Sham tDCS will be delivered to parieto-occipital areas for five consecutive days. tDCS will be delivered by a battery driven, direct current stimulator through a pair of saline-soaked sponge electrodes kept firm by elastic bands. The electrodes will be placed on the left (anodal) and right (cathodal) parieto-occipital areas, PO7 and PO8 position according to the 10-20 international EEG system for electrode placement. Stimulation intensity will be set at 1 milliampere (mA), but the current will be applied for 30 s and will be ramped down without the participants awareness.
15824971|NCT04244565|Behavioral|Self-directed model of clinical learning for nurses|the instructors play a facilitating role while, learners actively participate in identifying their own learning needs, learning goals, allocating resources & decide whether learning method can be used, and engaging in self-reflection & evaluation.
15824974|NCT04244539|Device|high-intensity laser Device.|Twenty four treatment sessions with pulsed Nd: YAG laser were applied to the subjects of the study group, three sessions per week, over 8 weeks in succession via HIRO® 3.0 device (ASAlaser, Arcugnano, Vicenza, Italy). The device gives pulsed emission (λ = 1064 nm), maximum power (3000 W), fluency range (360-1780 mJ/cm2), pulse duration (≤ 100 μs), frequency range (10-40 Hz), maximum energy per pulse (350 mJ), mean power (10.5 W), and power cycle of ~0.1%.
15824975|NCT04244526|Other|Talking a urine sample|Just taking a urine sample
15824976|NCT04244513|Device|Deep brain stimulation|the HD-DBS arm will be routinely activated after surgery and then stimulated for 6 months(6 months stimulation). The HD-shamDBS arm will be re-launched 3 months after surgery, continued stimulation for 3 months(3 months stimulation), and then entered the open study.
15824977|NCT04244500|Procedure|swab sampling|Multiplex polymerase chain reaction assay for organisms of upper respiratory tract infections
15824978|NCT04244487|Procedure|laparoscopic splenectomy and azygoportal disconnection with intraoperative endoscopic variceal ligation|"The modified procedure was implemented in the following order: (1) find the left crural diaphragm; (2) via the surface of the left crural diaphragm, divide the left lateral surface of the distal esophagus; (3) divide the posterior surface of the distal esophagus; (4) divide the anterior surface of the distal esophagus; (5) divide the lesser omental sac via the bottom right crural diaphragm; (6) transect en bloc the left gastric artery and vein and posterior gastric veins using a linear laparoscopic vascular stapler; (7) find the right crural diaphragm by dividing a small portion of the hepatogastric ligament at the left lateral esophagogastric junction; and (8) via the surface of the right crural diaphragm, divide the right lateral surface of the distal esophagus.
~After the procedure of laparoscopic azygoportal disconnection, intraoperative endoscopic variceal ligation was made if the diameter of the esophageal varices was >5 mm."
15824979|NCT04244474|Drug|A single one ml injection|All children were treated with antibiotics according to WHO classification and treatment of childhood pneumonia at health facilities 2012 [18], at enrollment after obtaining consent from parents and completing the baseline assessment, children were given a single injection of one ml of 100.000 IU of vitamin D3 (Cholecalciferol), vitamin D3 obtained from 2 ml vials containing 200,000 IU each (Devarol- S- 200.000 I.U. produced by Memphis for Pharmaceutical and Chemical Industries) and stored in manufacturer's recommended conditions in a dry, cool environment for 1-16 weeks (depending on the date of recruitment) or placebo which is 1 ml saline injection. Syringes were labeled with a unique ID number and given by the blinded doctors choosing the next syringe with a randomization code. (only office secretary aware of randomization codes).
15824980|NCT04244461|Behavioral|Personalized Normative Feedback|The personalized normative feedback (PNF) focuses on behavioral norms, where participants see (1) how their perceptions compare to other same-gender veterans' actual drinking and (2) how their actual drinking compares to other same-gender veterans' actual drinking. The format of the intervention highlights typical days per week, drinks per occasion, and binge drinking as per traditional PNF interventions. PNF will also contain a video description of theories of normative influence (e.g., how individuals are affected by perceptions) and a description of the normative data sample. Participants also see enhanced PNF content that will focus on sharing with participants treatment information that the investigators obtained from a pilot sample.
15824981|NCT04244448|Drug|receive dissolved form of BIKTARVY®|The healthy volunteers will receive dissolved form of BIKTARVY® Pharmacokinetic samples will be taken at the following times: 0 hour (right before taking Biktarvy®); 0.5 hour; 1 hour; 1.5 hours; 2 hours; 2.5 hours; 3 hours; 4 hours; 8 hours; 12 hours; 24 hours; 36 hours; 48 hours and 72 hours (after Biktarvy®).
15824982|NCT04244448|Drug|receive crushed form of BIKTARVY®|The healthy volunteers will receive crushed form of BIKTARVY® Pharmacokinetic samples will be taken at the following times: 0 hour (right before taking Biktarvy®); 0.5 hour; 1 hour; 1.5 hours; 2 hours; 2.5 hours; 3 hours; 4 hours; 8 hours; 12 hours; 24 hours; 36 hours; 48 hours and 72 hours (after Biktarvy®).
15824983|NCT04244448|Drug|receive solid form of BIKTARVY®|The healthy volunteers will receive solid form of BIKTARVY® Pharmacokinetic samples will be taken at the following times: 0 hour (right before taking Biktarvy®); 0.5 hour; 1 hour; 1.5 hours; 2 hours; 2.5 hours; 3 hours; 4 hours; 8 hours; 12 hours; 24 hours; 36 hours; 48 hours and 72 hours (after Biktarvy®).
15824984|NCT04244435|Procedure|CABG|coronary artery bypass grafting with and without cardiopulmonary bypass
15824985|NCT04244435|Drug|thoracic epidural analgesia|thoracic epidural analgesia at the level of 1-10 thoracic vertebrae (ropivacainum 0,2-0,5% 5-10 ml/h)
15824986|NCT04244435|Drug|analgesia of opioids|Opioids will be used for perioperative analgesia
15824987|NCT04244422|Other|PIEZOSURGERY VERSUS CONVENTIONAL SURGERY|Piezosurgery: SATLEC ACTEON peizotome 2 (A company of ACTEON Group, France) was used. Conventional surgery with rotary instruments
15824988|NCT04244396|Device|TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™ (TactiCath SE)|TactiCath SE is indicated for use in cardiac electrophysiological mapping (stimulation and recording), and, when used in conjunction with a radiofrequency generator, for cardiac ablation of supraventricular arrhythmias in the right and left atrium, including atrial fibrillation.
15824989|NCT04244383|Diagnostic Test|interleukin IL-1beta and interleukin IL-18|pro-inflammatory cytokines measured in the serum
15824993|NCT04244318|Behavioral|Video-feedback ODISEA 2.0|Video-feedback intervention which ODISEA 2.0 (Gómez & Maureira, 2017), which incorporates an attachment theory framework, this intervention was constructed within the ODISEA's comprehensive and formative model of parenthood which was developed in Chile.
15824994|NCT04244305|Other|Exercise Therapy|Endurance training in the form of treadmill/cycle-ergometry
15824995|NCT04244292|Other|Videolaryngoscopy|Patient will be intubated by using videolaryngoscope
15824996|NCT04244279|Other|Ergonomic workshop|Participants will participate in a single meeting workshop regarding ergonomic principles in baby care.
15824997|NCT04244279|Other|Brochure|Participant will receive a brochure summarizing the main contents of the workshop.
15824998|NCT04244279|Other|Videos|During the next three months after the beginning of the research, they will receive videos that will be a reminder of the principles learned in the workshop.
15824999|NCT04244266|Other|NO INTERVENTION, it is an observational study|No intervention
15825000|NCT04244253|Drug|OPC-64005 20 mg , Once-daily|Active, High Dose
15825001|NCT04244253|Drug|OPC-64005 10 mg , Once-daily|Active, Low Dose
15825002|NCT04244253|Drug|Placebo, Once-daily|Placebo
15825003|NCT04244240|Behavioral|BEARNI Tool|"BEARNI is brief screening tool initially validated for Alcohol-related neuropsychological impairments (Ritz et al., 2015). BEARNI tool detect impairment in visuospatial abilities, executive functions, verbal episodic memory, and verbal working memory.
~The score of the test could be expressed as a global score, and also as subscores corresponding to each cognitive subtest. Normative data are available."
15825004|NCT04244227|Device|Empower Neuromodulation System|Peripheral nerve stimulation with the Empower device. The active and sham treatments only differ by the location of application on the body.
15825005|NCT04244214|Other|More Stamina|More Stamina is a gamified task organization tool designed to help persons with MS manage their energy, to minimize the impact of fatigue in their day to day life.
15825006|NCT04244201|Device|Vaporous Hyperoxia Therapy|1 hour of treatment, 4 times per week
15825007|NCT04244188|Other|Collection of datas|Collection of datas: pre- and postoperative scanner and endoprosthesis characteristics
15825008|NCT04244175|Drug|CVL-865|Participants will receive CVL-865 tablets orally BID up to the maximum dose of 7.5 mg BID or 25 mg BID during the treatment period.
15825009|NCT04244175|Drug|Placebo|Participants will receive CVL-865 matched placebo tablet orally BID during the treatment period.
15825010|NCT04244162|Diagnostic Test|Brain Imaging|Magnetic resonance imaging (MRI) using diffusion tensor imaging (DTI)-based mean diffusivity (MD) measures.
15825011|NCT04244162|Diagnostic Test|Cognitive testing|Wide Range Assessment of Memory and Learning (WRAML2), Montreal Cognitive Assessment (MoCA), and Confusion Assessment Method for the ICU -severity (CAM-ICU S) tests.
15825012|NCT04244162|Diagnostic Test|Blood Biomarkers|Inflammatory markers
15825013|NCT04244149|Other|Prolonged Exercise session|After a standardized warm-up of 10 minutes of continuous running on a treadmill at 60% of their maximum heart rate (HRmax), subjects will perform a maximum oxygen consumption test (VO2max) with a gas analyzer (UltimaTM Series, MGC Diagnostic Corporation, St. Paul, MN, USA. The protocol will start with a slope of 1% at a speed of 10 km/h, with increments of 0.3 km/h every 30 s until volitional exhaustion. Finally, ten minutes after the treadmill test, volunteers will run 1 kilometer (t1km) as fast as possible and the time needed to cover the distance will be recorded.
15825014|NCT04244136|Device|contrast CT|contrast CT abdomen fir measurement of the volume of expected residual normal renal tissue before surgery
15825015|NCT04244123|Combination Product|integrated information and nurse led telephone clinic|combining web-based information from easypod connect with nurse led telephone clinic
15825016|NCT04244097|Drug|Bupivacaine Hydrochloride|after induction of general anesthesia and before the start of surgery, after inflating the pneumoperitoneum and before any surgical manipulation, the surgeon infuse 50 mL of blinded solution (bupivacaine or bupivacaine neostigmine) intraperitoneally to the sub-diaphragmatic space and gall bladder area guided by the camera and the patients are kept in Trendelenburg position for 5-10 minutes. Thereafter all patients will be positioned in the anti-Trendelenburg position to start the surgery and the laparoscopic procedure will be carried out in a standard fashion.
15825017|NCT04244097|Drug|Neostigmine|after induction of general anesthesia and before the start of surgery, after inflating the pneumoperitoneum and before any surgical manipulation, the surgeon infuse 50 mL of blinded solution (bupivacaine or bupivacaine neostigmine) intraperitoneally to the sub-diaphragmatic space and gall bladder area guided by the camera and the patients are kept in Trendelenburg position for 5-10 minutes. Thereafter all patients will be positioned in the anti-Trendelenburg position to start the surgery and the laparoscopic procedure will be carried out in a standard fashion.
15825018|NCT04244084|Drug|MMH-407|Oral use.
15825019|NCT04244084|Drug|Placebo|Oral use.
15825020|NCT04244071|Device|Bair Paws Blanket 81003 and FOC device 87500|This study is a randomized, pretest - posttest controlled experimental design.
15825021|NCT04244071|Other|routine hospital care|routine hospital care
15825022|NCT04244058|Drug|Amantadine + L-DOPA|Amantadine 150 mg L-DOPA 375mg/carbidopa 75mg
15825023|NCT04244058|Drug|NMDA blocker|NMDA blocker
15825024|NCT04244045|Other|Suboccipital muscle inhibition|"The patient was asked to flex his hip joint with complete knee extension and ankle in neutral position. The therapist stretches the hamstring of the dominant side; distal hand of the therapist on planter surface of foot for dorsiflexion. and proximal hand on the knee to increase the length of the muscle, maintain this stretching for 60 seconds then relax .Sub occipital muscle inhibition:
~The Patient is supine, The therapist stretch the sub occipital, flexes the head of the patient to get the chin to the manibiurim sternii, maintaining this position for 60seconds then relax Slump strtch position:Patient in comfortable short sitting position at the edge of the bed with the trunk in an millitary straight position then ask the patient to slump the flex his neck and street the knee joint in complete extension the at the end of the procedure do active dorsiflexion at the tested foot"
15825025|NCT04244032|Behavioral|Working Memory Training|Participants complete up to 12 sessions of computerized training (30-45 min each) in a working memory task designed to utilize individually-adapted difficulty levels.
15825026|NCT04244032|Behavioral|Inhibitory Control Training|Participants complete up to 12 sessions of computerized training (30-45 min each) in an inhibitory control task designed to utilize individually-adapted difficulty levels.
15825027|NCT04244032|Behavioral|Bias Modification Training|Participants complete up to 12 sessions of computerized training (30-45 min each) in a bias modification task designed to utilize individually-adapted difficulty levels.
15825028|NCT04244006|Drug|Dupilumab Prefilled Syringe|administration of dupilumab corresponding to dupilumab arm
15825029|NCT04244006|Other|Placebo Prefilled Syringe|administration of placebo corresponding to placebo arm
15825030|NCT04243993|Other|Calcium silicate cement|Calcium silicate cement for using in endodontic treatments i.e. pulpotomy, orthograde MTA apical barrier, root perforation repair, and endodontic microsurgery.
15825031|NCT04243980|Device|Short anatomical femoral stem in THR|Patients with osteoarthritis after total hip arthroplasty
15825032|NCT04243967|Other|Music therapy|"On the surgery day, the patient is accompanied by music-therapist all the way from her room to the operating theatre in order to monitor and adapt music-therapy intervention.
~The patient, prior to the anesthetic, take faces 3 phases of music therapy intervention (1 hour):
~1° Phase Active Music therapy: the patient takes part in a session of live improvisational music therapy, with the therapist, to elaborate pre-operative stress.
~2° Phase Relaxation with Receptive Live Music: music therapist play live to relax patients with autogenic training and tunnings breathing.
~3° Phase playlist listening based on the patient's needs. Patients listen to music with an mp3 player with earphones within the ear canal (H&H CE mp3/Usb; Headphones on Air in-ear with volume control) with a maximum volume of 60 dB (previously set with a sound level meter)."
15825033|NCT04243967|Other|Control|Standard perioperative management including perioperative care (without the use of music / music therapy)
15825034|NCT04243954|Drug|PCA IV Hydromorphone (continuous dose = 0)|Intravenous PCA with hydromorphone after successful titration of 24 hours. the PCA setting: 1) continuous dose = 0; 2) bolus dose = 10-20% of the total dosage of hydromorphone in the previous 24 hours: 3) lockout time = 10 minutes; 4) evaluate once every 24 hours
15825035|NCT04243954|Drug|PCA IV Hydromorphone (continuous dose ≠ 0)|Intravenous PCA with hydromorphone after successful titration of 24 hours. the PCA setting: 1) continuous dose (dose/hours) = the total dosage of hydromorphone in the previous 24 hours/24; 2) bolus dose = 10-20% of the total dosage of hydromorphone in the previous 24 hours; 3) lockout time = 10 minutes; 4) evaluate once every 24 hours
15825036|NCT04243954|Drug|Oral morphine|"Swift to sustained-release morphine orally as background dose with immediate release morphine orally for breakthrough pain after successful titration of 24 hours.
~Administration of morphine orally 1) Sustained-release morphine orally (dose/12 hours) = the total equianalgesic of the previous 24 hours/2×75% for d1; the total equianalgesic of the previous 24 hours/2 for day 2 and day 3; 2) Immediate release morphine orally = 10-20% of the total equianalgesic of the previous 24 hours; 3) Evaluate once every 24 hours"
15825037|NCT04243941|Drug|68Ga-HBED-CC-PSMA|Radioactive tracer used during imaging to help detect PSMA expressing tumor cells
15825038|NCT04243928|Other|kinesio taping|apply kinesio taping on dorsi flexors muscles
15825039|NCT04243915|Other|Percutaneous neuromuscular electrical stimulation (PNMES)|The technique consists of a muscular stimulation of the deep lumbar multifidus by means of a TENS current applied through four dry needling or acupuncture needles introduced by ultrasound guidance in said muscle 30 minutes. This will add to a protocol of motor control exercises for deep abdominal and lumbar muscles.
15825040|NCT04243915|Other|Sham PNMES (introducing the needle) plus motor control exercise program|The same procedure will be performed as in the experimental treatment, but in this case, the electric current will be placebo and only the first 15 seconds will slightly notice it. This will add to a protocol of motor control exercises for deep abdominal and lumbar muscles.
15825041|NCT04243915|Other|TENS plus motor control exercise program|Transcutaneous electrical nerve stimulation will be applied through 4 patches / adhesives placed in your lower back for 30 minutes. This will add to a protocol of motor control exercises for deep abdominal and lumbar muscles.
15825042|NCT04243915|Other|Placebo PNMES (without inserting the needle) plus motor control exercise program|The same procedure will be performed as in the experimental treatment, but in this case, the needle will not be inserted and the electric current will be placebo and only the first 15 seconds will slightly notice it. This will add to a protocol of motor control exercises for deep abdominal and lumbar muscles.
15825043|NCT04243902|Device|Fill and Flush Valve|"The fill and flush valve (Figure 1) is an automated valve which is designed to open in response to rising bladder pressure which occurs as the bladder becomes full. The valve is situated between the IDC and the drainage bag as a manual valve would be.
~There are three variants of the valve which respond to different degrees of bladder pressure. People's bladders function at different pressure levels. One of the aims of this study is to gain preliminary data on which valve variant works and under which circumstances. Pressure ranges are as follows:
~Low: 22 - 49cm H2O Medium: 35 - 61cm H2O High: 53 - 79cm H2O"
15825044|NCT04243889|Device|NEOX Cord 1K applied fetoscopically|Under general anesthesia and tocolysis, in-utero repair starts with a laparotomy, followed by exteriorization of the uterus and external cephalic version to position the fetus. Uterine entry will be accessed using 3 cannulas, followed by heated-humidified carbon dioxide insufflation for visualization. Fetoscopically, the placode will be dissected and the lesion repaired. NEOX Cord 1K®, a cryopreserved human umbilical cord patch, will be used for meningeal closure over the spinal cord, followed by closure of the fetal skin layer. Next, the carbon dioxide will be removed and replaced with amniotic fluid or with Lactated Ringers Solution. Finally, the fetoscopic hysterotomy sites will be sutured, and the laparotomy site closed in multiple layers.
15825045|NCT04243876|Diagnostic Test|paraoxanase enzyme level|presence of paraoxonase enzyme deficiency and associated troponin elevation
15825046|NCT04243863|Drug|VNRX-7145|Part 1: one dose Part 2: 28 doses (once every 8 hour [q8h] dosing for 9 days with a single morning dose on Day 10)
15825047|NCT04243863|Drug|Placebo|Part 1: one dose Part 2: 28 doses (once every 8 hour [q8h] dosing for 9 days with a single morning dose on Day 10)
15825048|NCT04243850|Drug|Empagliflozin 10 MG|Jardiance
15825049|NCT04243850|Drug|Placebo oral tablet|Placebo
15825050|NCT04243850|Diagnostic Test|Caffeine|caffeine iv to investigate wheter the changes in renal hemodynamics are adenosine dependent
15825051|NCT04243837|Drug|LYT-100|"LYT-100 is a deuterated form of pirfenidone, an orally active small molecule drug.
~HV subjects will receive multiple ascending doses, starting at 100 mg BID up to 1000 mg, with food for 5-days."
15825052|NCT04243837|Other|Matching Placebo|Inactive capsule(s)
15825347|NCT04241432|Device|vibrating platform|Use of two different types of vibrating platform
15825053|NCT04243837|Drug|LYT-100 Food Effect|"LYT-100 is a deuterated form of pirfenidone, an orally active small molecule drug.
~HV subjects will receive one dose of LYT-100 or Placebo"
15825054|NCT04243837|Drug|LYT-100 BCRL|BCRL patients will receive LYT-100 BID for 6 months
15825055|NCT04243837|Drug|Placebo BCRL|BCRL patients will receive Placebo BID for 6 months
15825056|NCT04243824|Drug|Gallium 68 Macro-aggregated albumin|The radiotracer, Ga-68 MAA, will be administered prior to PET/MRI scan.
15825057|NCT04243811|Device|Diode Laser|LLLT with dental needle for local anesthesia during dental treatment
15825058|NCT04243811|Other|topical anesthesia|topical anesthesia with dental needle for local anesthesia during dental treatment
15825059|NCT04243798|Device|Active TBS-DLPFC|"Participants in the active stimulation group will receive intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the Soterix Neural Navigator neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004).
~Stimulation will be delivered to the L-DLPFC using a MagPro TMS system (MagVenture, Denmark)."
15825060|NCT04243798|Device|Sham TBS-DLPFC|The parameters in the sham arm will be as above with the internal randomization of the device internally switching to sham in a blinded fashion.
15825061|NCT04243785|Drug|BTX-A51|Orally administered capsules available in strengths of 0.5 mg, 1.0 mg, and 2.0 mg.
15825062|NCT04243772|Other|Data extraction|Data extraction from medical files
15825063|NCT04243759|Behavioral|Control App Version|"The control version is a smartphone-compatible CGNG. The cued go/no-go (CGNG) tests ability to respond fast to go targets (activation) while withholding response to no-go targets (inhibition)."
15825064|NCT04243759|Behavioral|Standard App Version|The standard version is the same as the control version with the exception that information about performance (correct or incorrect) is displayed along with RT in ms for a correct response during each inter-trial interval.
15825065|NCT04243759|Behavioral|Experimental, Feedback App Version|The experimental, feedback version includes the standard plus feedback on RT and inhibition errors compared to pre-drinking. The app will state that there are simple alternatives with invitation to press a box to view advice, based on research that risk information may increase risky behavior if convenient options are not given73. Feedback will be worded non-judgmentally per motivational interviewing tenets.
15825066|NCT04243746|Behavioral|Time Restricted Feeding|Subjects practise TRF (2-3 meals) as an adjunct to the QQH healthy plate diet. Subjects of the intervention group can eat during the pre-determined 8-12 hours eating window, but they are only allowed to drink water and calorie-free drinks for the remaining 12-16 hours. Subjects are allowed to decide the time of their first and the last meal of the day as long as they eat within the 8-12 hour window period. However, skipping breakfast and having late dinner are discouraged.
15825067|NCT04243746|Behavioral|Standard Care|Subjects practice the QQH healthy plate diet as per guidelines set by the Health Ministry the guidelines.QQH refers to a normal food plate (23cm in diameter), divided into a quarter of rice (carbohydrates), a quarter of meat (protein) and a half plate of vegetables and fruits. Additionally, no calories specification is required and snacks are discouraged.
15825068|NCT04243733|Other|CEM and MTA|Pulpotomy agent
15825069|NCT04243733|Other|MTA and CEM|Pulpotomy agent
15825070|NCT04243694|Behavioral|Mindfulness training|Participants of the intervention group will receive 6-weeks of mindfulness training.
15825071|NCT04243681|Combination Product|CD 34 and MSC infusion|Combination of stem cells
15825072|NCT04243681|Drug|Standard of care for Cirrhosis management|Drugs used for Cirrhosis management such as Diuretics, Hepatoprotective agents and Lactulose
15825073|NCT04243668|Procedure|ANTI REFLUX MUCOSAL ABLATION THERAPHY (ARMA)|"In patients fulfilling inclusion criteria and willing for ARMA, the procedure involves ablation of the mucosa of the EGJ using TT knife (ARMA). Subsequently, saline solution mixed with indigo-carmine is injected at the submucosa level to raise a submucosal bleb, followed by ablation of the mucosa along the lesser curvature using TT knife.The approximate duration of the procedure is 40min.
~Follow up will include objective evaluation of reflux disease with: upper endoscopy, esophageal manometry, pHmetry,reflux questionnaire."
15825074|NCT04243655|Device|HA 330-II|One unit for 2-4 hours treatment, for 3 consecutive days
15825075|NCT04243655|Drug|Standard medical treatment (SMT)|SMT as per patients requirement- Management of cerebral edema/intracranial hypertension: prophylactic antibiotics, administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure, volume replacement and pressor support (noradrenaline, doubutamine, dopamine) as needed, NAC and correction of metabolic parameters.
15825076|NCT04243642|Device|IntelliSpace Cognition|Philips IntelliSpace Cognition (ISC) is a digital assessment platform that supports Healthcare Professionals (HCP) in assessing the cognition of individuals. It consists of two interfaces connected to the DCDx-module in the cloud. ISC is hosted on the Philips Health Suite Digital Platform (HSDP). The first interface is the patient's interface and is presented via a tablet to collect data on how the patient performs a series of tests. The second interface is the clinician's interface and can be used on any PC or tablet. It allows for assessments to be selected and administered, observations made, data analytics performed and the generation of a report.
15825077|NCT04243629|Drug|Rapid-Acting Insulin|Novorapid or Humalog insulin delivered in a basal-bolus manner.
15825078|NCT04243629|Drug|Placebo|Placebo (saline) delivered in a basal-bolus manner at a fixed ratio with insulin.
15825079|NCT04243629|Drug|Pramlintide Acetate|Pramlintide acetate delivered in a basal-bolus manner at a fixed ratio with insulin.
15825080|NCT04243629|Device|Artificial Pancreas|Tandem insulin pump, Dexcom G5 sensor, Nexus 5 cellphone running the iMAP algorithm.
15825081|NCT04243616|Drug|Cemiplimab|350 mg, IV, Day 1 of Cycle 1-2 (3-week cycle)
15825082|NCT04243616|Drug|Paclitaxel|80 mg/m^2, IV, Day 1,8 and 15 of Cycles 1-4 (3-week cycle)
15825083|NCT04243616|Drug|Carboplatin (not mandatory)|Area under curve (AUC)=6, IV, Day 1 of Cycles 1-4 of Paclitaxel cycles (3-week cycle)
15825084|NCT04243616|Drug|Doxorubicin|60 g/m^2, IV, Day 1 of Cycles 1-4 of ddAC (2-week cycle)
15825085|NCT04243616|Drug|Cyclophosphamide|600 g/m^2, IV, Day 1 of Cycles 1-4 of dose-dense Adriamycin (Doxorubicin) and Cyclophosphamide (ddAC) (2-week cycle)
15825086|NCT04243603|Behavioral|Internet-based Emotion Regulation Individual Therapy for Adolescents (ERITA-DK)|Please see description of experimental arm (arm one)
15825316|NCT04241692|Device|CarnationTM Ambulatory Monitoring Sternal ECG Patch System|A newly developed cardiac rhythm monitoring system
15825087|NCT04243590|Behavioral|Hand-Use-at-Home Questionnaire (HUH)|The HUH assesses the amount of spontaneous use of the affected hand in children with unilateral upper limb paresis aged 3-10 years, performing 18 typical bimanual play and self-care activities. Parents rate items using a 5-point rating scale (never-sometimes-regularly-often-always). After completion, the ratings are converted into a 3-point score (i.e. never/sometimes = score 0, regularly/ often = score 1, always = score 2). A sum score can be calculated (range 0-36).
15825088|NCT04243590|Behavioral|Pediatric Outcome Data Collection Instrument (PODCI)|The PODCI is designed to assess different aspects of daily living in children with musculoskeletal disorders. It has excellent psychometric properties, and it is a widely accepted instrument to provide parent/patient-reported information about upper extremity functioning. A Dutch version is available and it is validated for children with neonatal brachial plexus palsy. It consists of 85 questions and five scale scores and one total score can be calculated (range for all scales and total score 0-100, higher scores indicating better functioning/quality of life). Only the Upper Extremity and Physical Function Scale (8 items) were used in this study since this scale provides information about difficulties performing activities using the arms/hands (score 0-100; lower score, more difficulties).
15825089|NCT04243590|Behavioral|Children's Hand-Use Experience Questionnaire (CHEQ)|"The CHEQ is a questionnaire for children (aged 6-18) with unilateral functional limitations of hand use and is well validated for children with unilateral cerebral palsy. It was only partially validated for use in children with neonatal brachial plexus palsy and has not yet been used in studies. Therefore, it was not used in this group. The questionnaire consists of 29 bimanual activities, typically requiring the use of both hands. It assesses the child's experience using their affected hand when performing the activities and counts how many of the activities are executed independently (with and without using the affected hand).
~In the mini-version of the CHEQ some items were deleted or replaced (with more age-appropriate activities for children aged three to eight years) and this version was used for all unilateral cerebral palsy children <six years in this study."
15825090|NCT04243577|Device|Tele-EaT Sensors|Several iterations of a wearable surface EMG sensors patch and a wearable intra-oral lingual press device that we will develop, will be tested against commercially available wired devices. The wearable sensor patch will be an ultrathin patch with a honeycomb-inspired design that includes sEMG and strain sensors in order to capture muscle activity and thyroid movement signals from the submental area during swallows and swallow maneuvers/exercises. The wearable intra-oral device will integrate a wireless intraoral sensor system that will allow simultaneous recording of lingual pressure and movement during swallows and lingual tasks in a wireless fashion. Participants will perform standardized swallow tasks with both devices.
15825091|NCT04243577|Device|Conventional Sensors|Conventional sensors will include snap-on wired electrodes and the use of the Iowa Oral Performance Instrument as the control conditions. The same set of standardized swallow tasks will be completed with the conventional and commercially available devices as well.
15825092|NCT04243564|Device|Supraglottic device (SGD)|Positioning of SGD as temporary ventilatory device before tracheal intubation
15825093|NCT04243551|Drug|Latiglutenase|Administered orally (daily)
15825094|NCT04243551|Other|Placebo|Administered orally (daily)
15825095|NCT04243538|Behavioral|I-HoME|I-HoME will consist of two components: (1) synchronous live video interactions between patients/CGs and a hospice nurse; and (2) educational videos.
15825096|NCT04243512|Behavioral|Time-restricted eating|Restrict food and beverage intake (except water) to a 10-hour window
15825097|NCT04243499|Biological|IV ICT01|humanized anti-Butyrophilin 3A (BTN3A) monoclonal antibody
15825098|NCT04243486|Drug|UHE-105|Topical shampoo containing active drug
15825099|NCT04243486|Drug|Vehicle|Topical shampoo containing no active drug
15825100|NCT04243460|Procedure|Xenogeneic collagen matrix (XCM) graft augmentation|"12 months after gingival augmentation Measurement of marginal bone level and soft tissue thickness were done. STT (soft tissue thickness) was measured using ultrasonography with a Pirop® dental, ultrasound device (Echoson Company, Poland). The patients underwent a clinical and ultrasound examination before, 3 and 12 months after gingival augmentation (GA) respectively to evaluate TKT at two points using ultrasound equipment (Pirop®, Echoson).
~Intraoral radiographs were taken using a paralleling technique with a Rinn-type film holder in high resolution mode (Visualixe HD®, Gendex®, USA). Two images of each region were selected to calculate the marginal bone changes:"
15825101|NCT04243460|Procedure|Connective tissue graft augmentation (CTG)|12 months after gingival augmentation Measurement of marginal bone level and soft tissue thickness were done. STT (soft tissue thickness) was measured using ultrasonography with a Pirop® dental, ultrasound device (Echoson Company, Poland). The patients underwent a clinical and ultrasound examination before, 3 and 12 months after gingival augmentation (GA) respectively to evaluate STT (soft tissue thickness) at two points using ultrasound equipment (Pirop®, Echoson).
15825102|NCT04243434|Drug|Vincristine Sulfate Liposome|Eligible patients will be randomized in a 1:1 ratio to one of 2 treatment cohorts (Cohorts A or B) to receive either the first cycle of treatment with the VSLI-RTU formulation or the Marqibo formulation and crossover to the other formulation for the second cycle.
15825103|NCT04243434|Combination Product|CHOP|CHOP to be administered on Day 1 on Cycle 1 & 2 ( 21-day Cycle) & prednisone administration on Days 2 to 5 on Cycle 1 & 2 ( 21-day Cycle)
15825104|NCT04243434|Combination Product|R-CHOP|R-CHOP to be administered on Day 1 on Cycle 1 & 2 ( 21-day Cycle) & prednisone administration on Days 2 to 5 on Cycle 1 & 2 ( 21-day Cycle)
15825105|NCT04243421|Device|Implantation|Soft tissue aesthetics, marginal bone level on CBCT
15825106|NCT04243408|Other|Autologous umbilical cord blood transfusion|single dose of an autologous umbilical cord blood transfusion
15825107|NCT04243408|Other|placebo|The placebo product will consist of the standard ingredients of the acellular content of the UCB unit. It will consist of 20 ml Dextran (Plander 40.000 - 50g/500ml, solution for infusion) and 20 ml of human Albumin 5% (solution for infusion). The volume of placebo product will be 40 ml
15825108|NCT04243395|Other|Pork|1 oz lean pork
15825109|NCT04243395|Other|Egg|1 large whole egg
15825110|NCT04243395|Other|Black beans|0.5 cups cooked black beans
15825111|NCT04243395|Other|Almonds|0.5 oz almonds
15825112|NCT04243382|Biological|Autologous umbilical cord blood|Single infusion of autologous umbilical cord blood cells
15825113|NCT04243382|Biological|Placebo|Placebo
15825114|NCT04243369|Device|Non-diagnostic software solution|Collaboration Live is a non-diagnostic software solution intended for use with Philips (Philips Ultrasound, 22100 Bothell Everett Highway, Bothell, Washington 98021) EPIQ and Affiniti Series Ultrasound Systems (software version 5.0.2) that allows users to communicate (by text, voice, screen share, webcam video and remote takeover) from an ultrasound system or workstation to a remote destination.
15825115|NCT04243356|Behavioral|Nurse Encounter Group|Nurses in this group will meet with former ICU patients in a post ICU clinic visit. This will be a structured meeting for approximately 15 minutes with the nurse and former patient. The encounter will be observed by a member of the research team. Surveys will be completed before and after the visits. Additionally, nurses will be interviewed 4-7 days after meeting with their former patients.
15825116|NCT04243356|Other|Nurse control group|This group will complete surveys.
15825117|NCT04243343|Device|Intervention + Standard of care|Acupuncture with electrostimulation plus standard of care prescribed home exercise program for treatment of plantar fasciosis.
15825118|NCT04243343|Other|Standard of care|Standard of care prescribed home exercise program for treatment of plantar fasciosis.
15825121|NCT04243317|Behavioral|Lifestyle & diet|The control group will receive lifestyle and dietary advice accompanied by meal replacements and dietary plans.
15825122|NCT04243317|Behavioral|Lifestyle, diet & sleep|The control group will receive lifestyle and dietary advice accompanied by meal replacements and dietary plans. The experimental group will additionally receive a sleep improvement program based on CBTi.
15825123|NCT04243304|Other|11C-UCB-J PET-CT|Positron Emission Tomography (PET) of synaptic vesicle protein 2A (SV2A) using the radioligand 11C-UCB-J.
15825124|NCT04243304|Other|18F-PE2I PET-MR|Positron Emission Tomography (PET) of dopamine transporter (DAT) using the radioligand 18F-FE-PE2I, and brain MRI performed simultaneously.
15825125|NCT04243278|Drug|Low-dose aspirin|81 mg of low dose aspirin PO for 6 months
15825126|NCT04243278|Drug|Placebo oral tablet|placebo PO for 6 months
15825127|NCT04243265|Procedure|MPFL reconstruction with fascia lata allograft|Reconstruction of MPFL using a fascia lata allograft. The rationale for this technique is to stabilize the patella and limit medium to long-term patellofemoral arthritic degeneration by restoring the MPFL in the most anatomical way possible, not using a tubular graft but an aponeurosis with biomechanical characteristics similar to the native MPFL. The MPFL reconstruction can be used alone or in association with the realignment of the extensor apparatus by transposition of the anterior tibial tuberosity, managing to correct most of the recurrent patellofemoral instabilities. Only in very serious particular cases is it necessary to perform more invasive additional procedures with a more uncertain clinical result (such as Trocleoplasty).
15825128|NCT04243252|Behavioral|Healthy Pantry Program|Food pantries will receive the Healthy Pantry Program online training, which will be completed by at least one pantry staff member and teaches pantry staff a novel traffic-light nutrition labeling system, a multilingual healthy recipe database, and how to use those and other behavioral economic strategies to implement simple interventions in the food pantry to promote client selection of healthier options. Onsite support by a registered dietitian is included.
15825129|NCT04243252|Other|Waitlist Control|Normal food pantry use for duration of the 9-month study period. Control pantries will have access to the Healthy Pantry Program after study is completed.
15825130|NCT04243226|Device|cerebral blood flow (CBF) through aerobic exercise|The aim of this study is to develop exercise prescription of TBI patients and then to evaluate the effectiveness of programmed aerobic exercise to improve cognitive performance, depression relief and quality of life with improvement of CBF
15825131|NCT04243213|Other|Vibration Plate|Vibration at 15° tilt, which means the patients partly use their own body weight (resistive vibration exercise).
15825132|NCT04243213|Other|Tilt at 15°|To compare if a possible effect derives from the vibration or the tilting only, a second group was added who will only receive 10 min of 15° tilt without the vibration.
15825133|NCT04243213|Other|Standard hospital mobilization|early mobilization of patients 24h post surgery, done routinely, and physiotherapy this is done routinely in all patients
15825134|NCT04243200|Other|Hypos can strike twice|"The Hypos can strike twice intervention involves ambulance staff providing treatment to patients experiencing hypos and advising them to access follow-up care by their GP/specialist diabetes team. This is backed up by giving patients a Hypos can strike twice information booklet which they can read when they recover."
15825135|NCT04243187|Other|Chilean Native Beans|"In each visit the participant would have to:
~Fill a survey of gastrointestinal symptoms and basal bowel movements (THE GASTROINTESTINAL SYMPTOM RATING SCALE (GSRS))
~Fill a survey of food consumption
~Bean plate intake
~Expired hydrogen test, which consists of exhaling air in a syringe every 20 minutes for 12 times (4 hours in total). During this time the participant can do quiet activities (not physical activity).
~Fill surveys of gastrointestinal symptoms (online or on paper), during the hydrogen test, at 12 and 24 hours (3 times). During this time (1 day before and 2 days later) the participant cannot eat other bloating foods (legumes, cauliflower, broccoli, lettuce, cabbage, artichokes, onions, topinambur and others described in the food survey)."
15825136|NCT04243174|Behavioral|SMS Messaging|Patients with type 2 diabetes will be recruited and will start receiving short SMS messages about physical activity, encouraging them to be more active and help them to build a healthy life style routine.
15825177|NCT04242810|Device|Sham rTMS|An electrical sham coil that produces the same auditory and somatosensory stimulations, without a significant magnetic field, will be used as an active control.
15825178|NCT04242810|Procedure|MRI scan|Participants will undergo an MRI scan directly after rTMS stimulation that will last less than 120 minutes. During the scan, subjects will encode and retrieve object pictures.
15825137|NCT04243161|Other|Experimental|"The study variables PIM, PEM, FVC, PEF and EQ-5D quality of life questionnaire will be measured on the first day when patient incorporated into the seating position in the patient's bed. Reassessments will be performed every two week till patient discharge from hospital. After that patient will be assessed after 4 month and 1 year after the SCI.
~SCIM III will be administered at discharge, 4 month later and 1 year after the injury.
~Common clinical practice (pulmonary expansion exercises,drainage of secretions and training of inspiratory muscles) + expiratory muscle training at 50% load after MIP measurement.
~The intensity of the treatment will be 50% of the PIM and PEM value (increasing the load in 2 cmH2O weekly). Three sets of 10 reps will be performed, with one total of 30 repetitions, resting 1 minute between each series.
~The sessions will be held once per day, from monday to friday, during the entire hospital admission."
15825138|NCT04243161|Other|Control|"The study variables PIM, PEM, FVC, PEF and EQ-5D quality of life questionnaire will be measured on the first day when patient incorporated into the seating position in the patient's bed. Reassessments will be performed every two week till patient discharge from hospital. After that patient will be assessed after 4 month and 1 year after the SCI.
~SCIM III will be administered at discharge, 4 month later and 1 year after the injury.
~Common clinical practice (pulmonary expansion exercises,drainage of secretions and training of inspiratory muscles) + expiratory muscle training at 30% load after MIP measurement.
~The intensity of the treatment will be 30% of the PIM value (increasing the load in 2 cmH2O weekly). Three sets of 10 reps will be performed, with one total of 30 repetitions, resting 1 minute between each series.
~The sessions will be held once per day, from monday to friday, during the entire hospital admission."
15825139|NCT04243148|Combination Product|Home exercise program for 12 months.|Physical exercise at home: At the beginning of the study, group sessions will be conducted with 5 patients of 1-hour duration, where they will be taught the individualized program according to their physical condition and they will be given the necessary material (pedaling, dumbbells and elastic bands) and paper support on the program, also using the Vivifrail method through infographics. The group session will be repeated every 3 months to check the compliance of the program by reviewing daily activity, evaluate possible problems and review the exercises. The program will consist of aerobic and anaerobic exercise by pedaling (cardiovascular resistance) and resistance exercises with dumbbells and elastic bands (muscular strength), flexibility training by stretching, and coordination and balance exercises. Patients will perform 3 sessions per week of 20-30 min. increasing progressively according to tolerance up to 45-60 min. each.
15825140|NCT04243148|Combination Product|Multispecies probiotic: Vivomixx®|"Multispecies probiotic: Vivomixx® is a probiotic mixture of 8 bacterial strains:
~Streptococcus thermophilus DSM 24731® / NCIMB 30438, Bifidobacterium breve DSM 24732® / NCIMB 30441, Bifidobacterium longum DSM 24736® / NCIMB 30435*, Bifidobacterium infantis DSM 24737® / NCIMB 30436*, Lactobacillus acidophilus DSM 24735® / NCIMB 30442, Lactobacillus plantarum DSM 24730® / NCIMB 30437, Lactobacillus paracasei DSM 24733® / NCIMB 30439, Lactobacillus delbrueckii subsp. bulgaricus DSM 24734® / NCIMB 30440**
~* Re-classified as B. lactis ** Re-classified as L. helveticus The active agent will be supplied as an envelope of 4.4 g with a dose of 450x109 million live bacteria per envelope with maltose and silicon dioxide as excipients, administered 2 times/day throughout the study."
15825141|NCT04243148|Combination Product|Branched-chain amino acids (BCAA)|Branched-chain amino acids (BCAA): In addition to the exercise program and the probiotic, patients in the intervention group will receive BCAA supplements (powder in 8:1:1 ratio in favor of L-leucine) 10 g 30-60 min. before the exercise session throughout the study, in order to enhance the effect of exercise on muscle mass and improve cognitive function. We have chosen this dose based on the literature data and the satisfactory results obtained with this dose in our previous study. BCAA supplements will be supplied by the Pharmacy Service of our center.
15825142|NCT04243148|Combination Product|No specific intervention.|Follow up as a clinical practice
15825143|NCT04243135|Device|ESWT|Extracorporeal shock wave therapy
15825146|NCT04243109|Drug|Pomalidomide + Cyclophosphamide + Dexamethasone|"Treatment Phase: Combination of Pomalidomide, Cyclophosphamide and Dexamethasone, days 1-21 every 4 weeks (28 day cycles), up to a total of 8 cycles:
~Pomalidomide: Treatment with Pomalidomide 4 mg / day 1-21 days in 28-day cycles is started. Dose reductions will be made based on the evaluation of hematological and non-hematological toxicity.
~Cyclophosphamide: Cyclophosphamide will be administered 15 mg / day, days 1-28 in 28-day cycles.
~Dexamethasone: Dexamethasone will be administered 40 mg / day, days 1, 8, 15 and 22 in 28-day cycles. In patients older than 75 years the dose will be reduced to 20 mg / day in the same previous schedule.
~Maintenance Phase: Combination of Pomalidomide and Dexamethasone. The last doses prescribed in the previous cycle will be maintained."
15825147|NCT04243096|Behavioral|Exercise-based Physical Therapy|Exercises for pain modulation, strengthening, and neuromuscular control
15825148|NCT04243083|Drug|TLL018 tablet, placebo|Oral QD
15825149|NCT04243070|Diagnostic Test|3-channel Holter ECG recording|3-channel Holter ECG recording for patients undergoing an EPS
15825150|NCT04243070|Diagnostic Test|12-channel Holter ECG recording|12-channel Holter ECG recording for patients undergoing a routine follow-up
15825151|NCT04243044|Device|Transcutaneous spinal stimulation|Transcutaneous spinal stimulation will be delivered for 30 minutes using cathodal stimulation with a single round electrode placed directly over the spine at the T11/T12 (and L1/2 for dual-site stimulation) spinous interspace, and a dispersive (reference) electrode placed over the umbilicus. For assessing different stimulation intensities, TSS will be delivered at frequency of 50Hz. Stimulation intensity will be set to the specified level determined through a pre-stimulation assessment (constant stimulation at 0.8x resting threshold, constant stimulation at dual sites at 0.8x resting threshold, bursting stimulation at 0.8x resting threshold). For assessment of varying stimulation frequencies (30, 50, 80 Hz), TSS will be delivered at 0.8xRT for 30 minutes. Treatments will be a minimum of 48 hours apart.
15825152|NCT04243031|Device|QFT Access|Measure of Interferon Gamma
15825179|NCT04242797|Device|Calmare|Skin is stimulated with an electrical voltage via electrode pads, variably distorted sine wave at ~47 Hz.
15825180|NCT04242797|Device|TENS|Skin is stimulated with an electrical voltage via electrode pads, 300 micro-second rectangle pulse at 47 Hz.
15825181|NCT04242771|Behavioral|Mindfulness|Subjects practice mindfulness before bedtime
15825153|NCT04243018|Behavioral|Acceptance and Commitment Therapy Group Treatment|The intervention presents, a mixture of instruction, discussion, and the use of metaphor and experiential activities designed to sensitise participants to the effects of self-stigma and shame on how they live their lives. This training condition provides instruction and experiences that train participants to notice, and then to override, the very human tendency to categorise and then avoid aversive thoughts and feelings and the people and situations that evoke them. The acceptance and commitment training condition will cover the following topics: (a) introduction to enacted and self-stigma (b) cognitive defusion/behavioural flexibility (c) acceptance vs. avoidance and control of emotions and thoughts and (d) values and committed action.
15825154|NCT04243018|Behavioral|Peer Support Group|The peer support group will allow participants to share and discuss experiences related to their experiences of homelessness, shame and stigma. The group will be facilitated by an expert in facilitating peer support groups with marginalised populations.
15825159|NCT04242979|Behavioral|Questionnaire about albumin use in liver cirrhosis|"Permission to carry out the study will be obtained from the Faculty's Ethics Committee.
~To achieve validity and reliability of the tool. It will be reviewed by two experts in the field of the study and necessary modification will be done.
~A pilot study will be 10% done to test the clarity and feasibility of developed tool.
~Each participant involved in the study will be assessed for his or her knowledge using (tool I).
~Data will be collected by personal interview with participants or via fulfilling online questionnaire taking in consideration data confidentiality.
~Application of the designed evidence based indications for human albumin use supported by the international guidelines will be done by researcher using (tool II).
~Evaluate the effect of the designed evidence based indications for human albumin use supported by the international guidelines on physicians' knowledge after 1 month using (tool I) in a random sample of those physicians"
15825160|NCT04242966|Other|Usual Care|Protein targets will be set using pre-ICU dry actual weight. For patients with BMI >30, ideal body weight based on a BMI of 25 will be used. We will endorse the guidelines for energy targets set forth by ASPEN/SCCM, especially as it pertains to the obese patient.
15825161|NCT04242966|Other|Higher Protein/Amino Acid Group|Protein targets will be set using pre-ICU dry actual weight. For patients with BMI >30, ideal body weight based on a BMI of 25 will be used. We will endorse the guidelines for energy targets set forth by ASPEN/SCCM, especially as it pertains to the obese patient.
15825162|NCT04242966|Other|Ultrasound measure|Patients will undergo the ultrasound measures at baseline (within 24 hours of randomization, day 10 days post randomization (if still in hospital) and just prior to hospital discharge. In the event that hospital discharge is prior to day 10, the day 10 measure will not be done.
15825163|NCT04242953|Drug|SCO-120|"Part A: single oral administration
~Part B: single oral administration in Period 1 and Period 2 (crossover design)
~Part C: multiple oral administration (14 day dosing)"
15825164|NCT04242953|Drug|matching placebo|"Part A: single oral administration
~Part C: multiple oral administration (14 day dosing)"
15825165|NCT04242940|Device|Fitting of Ponto 4|Bone-anchored hearing systems (BAHS) use the body's natural ability to transfer sound through bone conduction. The sound processor picks up sound and converts it into vibrations that are transferred through the skull bone to the inner ear (cochlea). Thus, for patients with conductive or mixed hearing losses, patients with lasting hearing loss following a middle ear disease or malformations (such as microtia), the vibrations are bypassing the conductive problem in the ear canal or middle ear. The intervention in this study is audiologically fitting one/two bone-anchored sound processors (Ponto 4) to patients that are already implanted with abutments.
15825166|NCT04242927|Drug|Nicotinic acid +Routine care|Nicotinic acid is administered orally at 50 mg (grade 2) or 100 mg (grade 3) three times daily with routine care.
15825167|NCT04242927|Drug|Routine care|Routinely apply urea ointment and provide best supportive care.
15825168|NCT04242914|Drug|Ketamine|Intravenous Ketamine, dose 0.5mg/kg in 100ml Sodium Chloride 0.9% over 40 minutes.
15825169|NCT04242914|Drug|Midazolam|Intravenous Midazolam, dose 0.03mg/kg in 100ml Sodium Chloride 0.9% over 40 minutes.
15825170|NCT04242901|Diagnostic Test|Faecal Immunochemical Test - OC Sensor, Eiken, Tokyo|Quantitative Faecal Immunochemical Test - OC Sensor, Eiken, Tokyo
15825171|NCT04242888|Other|pragmatic manual therapies|three of the intervention are novel and the rest of the interventions are in practice but seldom used to treat the shoulder disorder.
15825172|NCT04242875|Diagnostic Test|Angle Kappa|Angle kappa will be measured using the OPD III scan.
15825173|NCT04242875|Other|Visual disturbance questionnaire.|Questionnaire evaluating visual disturbances.
15825174|NCT04242836|Diagnostic Test|MNREAD testing|One randomly selected eye is included for each study participant. Participants respond to the near vision chart with defined environmental circumstances at 40cm viewing distance. All four parameters (RA, MRS, CPS and ACC) are evaluated.
15825175|NCT04242823|Diagnostic Test|Automated visual evaluation|Participants will undergo primary hrHPV testing and if positive will be referred for VIA per Botswana and WHO guidelines. Participants will also undergo colposcopy, image capture for automated visual evaluation and biopsy at the time of VIA.
15825176|NCT04242810|Device|rTMS|TMS will be applied over task-based target at an intensity up of 130% rMT. The optimal coil placement during stimulation will be guided using the BrainSight neuronavigation system.
15825184|NCT04242745|Behavioral|Intervention group|"The elderly in this group were trained using the For Your Health For Fluid training booklet and a projection device, and after training, all individuals were given a training booklet. The training was carried out individually in a room reserved for training and took an average of 25-30 minutes.
~A Beyid wristwatch was used. This spoke the time in Turkish, every hour on the hour. In this way, the old people were reminded to drink a glass of liquid each hour. The watch had an alarm capability, and could be taken on to sleep mode at night in order not to wake the old people."
15825185|NCT04242745|Behavioral|Control group|"The elderly in this group were trained using the For Your Health For Fluid training booklet and a projection device, and after training, all individuals were given a training booklet. The training was carried out individually in a room reserved for training and took an average of 25-30 minutes."
15825186|NCT04242732|Diagnostic Test|CT scan of the knee under weight-bearing with the Cone Beam Computed Tomography (CBCT) scanner system.|The patient will be evaluated under weight-bearing, with knee flexed at 30 ° and therefore with contracted thigh muscles. The measurement and maintenance of the 30 ° of flexion will be controlled by a goniometer applied laterally to the knee and fixed by means of an elastic band.
15825187|NCT04242732|Diagnostic Test|Conventional CT scan|The patient will be evaluated in supine position, with the muscles relaxed and the knee in full extension by conventional CT scan
15825188|NCT04242719|Device|Electromagnetic stimulation|Retinal electromagnetic stimulation A high-frequency repetitive electromagnetic stimulation protocol has been defined in the literature and was applied in groups 1 and group 2 via a novel device developed specifically for ophthalmic usage (Magnovision-TM, Bioretina Biyoteknoloji AŞ, Ankara,Turkey). The patients underwent 10 consecutive sessions of rEMS application. Parameters for the treatment were 42 hertz frequency/min, 30 minutes of duration and mild operating cycle. The power of the electromagnetic field was 2000 milligauss, which is a very low dose and within the safety limits of World Health Organisation. In group 2, sub-tenon aPRP injections were also performed immediately after the first, fifth, and tenth sessions of rEMS application.
15825189|NCT04242719|Biological|Platelet rich plasma|About 20 ml of blood was drawn from the patient's antecubital vein and inserted into two 10-ml vacutainer tubes that contain trisodium citrate (T-LAB PRP Kit, T-Biyoteknoloji, Bursa, TURKEY). These tubes were placed in a refrigerated (+4 °C) centrifuge (Nüve NF 1200R, Nüve Laboratuar Teknolojileri, Ankara, TURKEY) and spun at 2500 rpm (580×g) for 8 min within 30 min of collection. Three different layers formed in the tubes: red blood cells at the bottom, platelet-rich plasma in the middle, and platelet-poor plasma in the top layer. A total of 1.5 ml of the middle layer (which mainly contained platelets) was withdrawn by syringe and immediately injected into the sub-tenon space of each eye after topical anesthesia with proparacaine hydrochloride (Alcaine, Alcon, USA) drops.
15825190|NCT04242706|Device|ETTEvac|Endotracheal tube with evacuation lumen without noble metal coating
15825191|NCT04242706|Device|BIP ETTEvac|Endotracheal tube with evacuation lumen with noble metal coating
15825192|NCT04242693|Behavioral|Mobile goal-setting intervention|This intervention applied two constructs from the goal setting theory-self-monitoring and goal setting. Briefly, all participants were asked to take photos of all their meals and upload them with descriptions to an online platform. The participants in the experimental group were taken through two additional processes that represented these two constructs. Self-monitoring was operationalized by asking those in the experimental group to count the number of times they ate red/orange vegetables using a counting checklist. Goal setting was operationalized as asking them to set a goal to eat red/orange vegetables one more time tomorrow.
15825193|NCT04242680|Device|Brainstim DLPFC|"The active tRNS will be delivered to bilateral DLPFC for five consecutive days for two weeks for a total of ten days.
~tRNS will be delivered by a battery driven, random-noise current stimulator through a pair of saline-soaked sponge electrodes kept firm by elastic bands.
~The electrodes will be placed on the left and right DLPFC, F3 and F4 position according to the 10-20 international EEG system for electrode placement, while participants will receive a usual treatment (cognitive training).
~Stimulation intensity will be set at 0.75 milliampere (mA) (100-500 Hz), the duration of stimulation will be 20 min."
15825194|NCT04242680|Device|Brainstim PPC|"The active tRNS will be delivered to bilateral PPC for five consecutive days for two weeks for a total of ten days.
~tRNS will be delivered by a battery driven, random-noise current stimulator through a pair of saline-soaked sponge electrodes kept firm by elastic bands.
~The electrodes will be placed on the left and right PPC, P3 and P4 position according to the 10-20 international EEG system for electrode placement, while participants will receive a usual treatment (cognitive training).
~Stimulation intensity will be set at 0.75mA (100-500 Hz), the duration of stimulation will be 20 min."
15825195|NCT04242680|Device|Brainstim Sham|The same electrode placement will be used as in the stimulation conditions (Brainstim DLPFC or Brainstim PPC), but the current will be applied for 30 s and will be ramped down without the participants awareness, and will be held five consecutive days for two weeks for a total of ten days.
15825196|NCT04242680|Behavioral|Cognitive Training|"A cognitive training (Vektor; Nemmi et al., 2016) will be adiministered concomitantly to Brainstim DLPFC, Brainstim PPC, Brainstim Sham for 20 min.
~The training consisted of math exercises (number line, calculations) and math-related exercises (visuo-spatial working memory, mental rotation)."
15825197|NCT04242667|Behavioral|e-Health (web-based) disclosure portal|Patient uses secure web-based portal to access genetic research results
15825198|NCT04242667|Behavioral|Provider mediated disclosure|Patient has disclosure of genetic research result by a provider (genetic counselor)
15825199|NCT04242654|Procedure|Handheld fetal doppler ultrasound|Handheld fetal doppler ultrasound will be used to assess heart rate in high-risk neonates.
15825200|NCT04242641|Behavioral|WW|WW is a structured lifestyle modification, weight-loss programme involving a programme for healthy eating, physical activity and positive mindset and support via attendance at local WW workshops and digital tools.
15825201|NCT04242628|Other|Facebook course|The intervention consists of the attendance to a course on Facebook and Social Networking Sites use
15825202|NCT04242628|Other|Lifestyle Course|The intervention consists of the attendance to a course on lifestyle education and brain functioning in older people
15825203|NCT04242615|Other|Prognostic score|
15825205|NCT04242589|Radiation|Radiotherapy|External beam radiation therapy is a type of radiation therapy used for cancer treatment. A machine is used to aim high-energy rays from outside the body into tumor
15825206|NCT04242589|Procedure|Vertebropladty|Vertebroplasty is a procedure for stabilizing compression fractures in the spine. Bone cement is injected into vertebrae that have cracked or broken. The cement hardens, stabilizing the fractures and supporting your spine.
15825207|NCT04242576|Device|Right Left Judgement|It is an application by Noigroup (Neuro Orthopedic Institute), adapted to different devices.
15825208|NCT04242576|Other|Action Observation|Videos of cervical movements.
15825209|NCT04242576|Behavioral|Exercise|Evidence based exercises for the neck.
15825210|NCT04242563|Other|VIRTUAL REALITY|Patient equipped with virtual reality in transfer room
15825211|NCT04242550|Behavioral|Executive Function- Enhanced CBT for BED (EF-BED+CBT)|EF-BED+CBT will combine CBT (see description below) with executive function training. EF-BED will focus on teaching compensatory strategies to enhance adherence to the strategies recommended in CBT.
15825212|NCT04242550|Behavioral|Cognitive Behavioral Therapy (CBT)|"CBT will be based on the Overcoming Binge Eating book. All participants will be provided a copy of the book. CBT addresses disturbed eating patterns and problematic thoughts/beliefs related to eating, shape and weight that contribute to binge eating. CBT is the current gold standard treatment for BED."
15825213|NCT04242537|Device|High flow nasal cannula oxygen delivery|It includes the delivery of oxygen through a high flow nasal cannula with head side elevation to 30 degrees to prevent desaturation and improve first pass success rate of endotracheal intubation
15825214|NCT04242537|Device|Low flow nasal cannula oxygen delivery|It includes the delivery of oxygen through a low flow nasal cannula coupled with head side elevation to 30 degrees to prevent desaturation and improve first pass success rate of endotracheal intubation
15825215|NCT04242524|Behavioral|Circadian Clock Alignment|Use timed lights and meals to align the circadian clock
15825216|NCT04242524|Behavioral|Circadian Clock Control|No circadian clock alignment
15825217|NCT04242511|Diagnostic Test|Measurement of tuberculosis medications level|Measurement of tuberculosis medication levels at 2 hours post-dose
15825220|NCT04242485|Other|Osteopathic manipulative treatment|Each osteopathic manipulative treatment consisted of a structured evaluation to diagnose somatic dysfunction of the pelvis, abdomen, vertebral spine, and upper and lower limbs (10 min), followed by the therapeutic application of manually guided forces to improve physiological function and homeostasis that has been altered by somatic dysfunction for 20 min, using techniques that were left at the discretion of the osteopath, including the myofascial release and cranial sacrum techniques
15825221|NCT04242485|Other|Sham treatment|"The sham treatment consisted only in soft touch of the same body areas involved in the osteopathic manipulative treatment protocol without applying any pressure"
15825222|NCT04242472|Behavioral|SMS-based Mobile Health intervention|Nutritional related SMS text message mobile health intervention will be provided to Tuberculosis patients.
15825223|NCT04242459|Radiation|Adaptive Radiotherapy|Determining the radiotherapy dose delivered to organs at risk (OAR) or to the target volume (dependent on what arm the participant is assigned to) through adaptive radiotherapy volume adaption planning
15825224|NCT04242446|Drug|Bimekizumab|Subjects will receive bimekizumab at pre-specified time-points.
15825225|NCT04242446|Other|Placebo|Subjects will receive placebo at pre-specified time-points during the Initial Treatment Period.
15825226|NCT04242433|Drug|Direct Acting Antivirals|"All subjects with viremic chronic hepatitis C will be given DAAs based on the MMPHCRF Treatment algorithm. Patients will be assessed for cirrhosis, prior treatment exposure, high risk groups like dialysis patients, HIV-HCV coinfection, etc. Accordingly treatment will be provided at any of the 25 peripheral centres or at the apex nodal treatment centre (PGIMER) of the MMPHCRF.
~Baseline and post treatment RAS samples will be collected with consent."
15825227|NCT04242420|Diagnostic Test|Genotyping|Genotyping for single nucleotide polymorphisms for Connexin 37&43, Mannose binding lectin (MBL) and transforming growth factor beta (TGF beta) genotypes
15825228|NCT04242420|Diagnostic Test|Lung function|Spirometry,
15825229|NCT04242420|Diagnostic Test|Microbiology|Bacterial culture from Sputum or swab
15825230|NCT04242420|Diagnostic Test|Blood sample|Interleukin-8 assay (via chemiluminescence) blood cell count
15825231|NCT04242420|Diagnostic Test|Induced Sputum|Interleukin-8 assay (via chemiluminescence) blood cell count
15825232|NCT04242407|Drug|DMTS|DMTS applied before surgery and worn for 96 hours
15825233|NCT04242407|Drug|Placebo|Matching patches that have no active drug applied before surgery and worn for 96 hours
15825234|NCT04242394|Procedure|ERCP|Routine ERCP procedures with gallbladder in situ patient
15825235|NCT04242381|Other|Cold Application|At the beginning of each treatment session, gel ice packs were wrapped in a damp towel and applied to the patients' shoulder joints for 20 minutes.
15825236|NCT04242381|Other|Kinesiotaping Application|KT was applied to the deltoid muscle using the inhibition and mechanical correction technique and to the supraspinatus muscle using the inhibition technique (2 sessions with a 5-day interval)
15825237|NCT04242381|Other|Exercise treatment|EX treatment was administered for 10 days with 3 sessions/day. A triphasic exercise program was administered to the patients. Before starting the exercise program, the patients were instructed to not perform the movements exceeding 90° overhead. The exercise program was initiated using codman pendulum, passive joint motion range (with a 1-m stick), and posterior capsule stretching exercise. Shoulder wheel, finger ladder, and shoulder strengthening exercise with theraband were added to the exercise programs of patients with full or near total range of motion and pain relief. Exercise was administered twice a week under supervision; however, the patients were advised to exercise at home on the other days with 20 repetitions of each exercise. The patients were followed up via telephone to make sure they were adhering to their exercise programs.
15825238|NCT04242381|Other|Sham Kinesio taping application|Sham-KT was applied in 10 cm I-shaped stripes on the sagittal plane over the acromioclavicular joint without stretching and on the transverse plane distal to the deltoid area. The kinesiotape was applied twice for five days with 2-day intervals
15825239|NCT04242368|Drug|Isotonic saline|Nasal isotonic saline irrigation (240 mL, 0.9% NaCl) administered through nasal rinse bottle.
15825240|NCT04242368|Drug|Hypertonic Nasal Wash|Nasal hypertonic saline irrigation (240 mL, 1.8% NaCl) administered through nasal rinse bottle.
15825242|NCT04242355|Behavioral|Transcranial Magnetic Stimulation (TMS)|Subjects will receive both active and sham TMS in a randomized crossover assignment involving two study sessions
15825243|NCT04242342|Radiation|Adaptative MR-Guided Stereotactic Body Radiotherapy|"If lesion near organs at risk:
~Prescription of 50 Gy in 5 fractions of 10 Gy
~3 sessions per week, with MRI guided stereotactic radiotherapy and daily adaptive treatment
~If lesion far of organs at risk:
~Prescription of 60 Gy in 6 fractions of 10 Gy
~3 sessions per week, with MRI guided stereotactic radiotherapy without daily adaptive treatment"
15825244|NCT04242329|Procedure|Surgical metastasectomy|Surgical removal of metastases aimed at R0 resection.
15825245|NCT04242329|Drug|Immunotherapy|Continued PD1-inhibitor treatment according to current treatment standards.
15825246|NCT04242316|Behavioral|Mirror Therapy|Patients performed customized bimanual upper limb exercises with graded level of difficulty based on the patient's individual levels of upper limb functioning according to the 7 levels of the FTHUE and each level consisted of 5 standardized table-top tasks. The patients practiced the movements with the unaffected hand (including the shoulder, elbow, wrist, and hand). While watching the reflection of the unaffected hand in the mirror, the patient was then asked to moving the affected hand at the same time to synchronize the movement with the reflection of the unaffected hand. If the patient was unable to move the hand, a therapist would passively assist the movement of the affected hand so as to synchronize it with the reflection of the unaffected hand.
15825247|NCT04242316|Behavioral|Bilateral arm training|Patients performed customized bimanual upper limb exercises with graded level of difficulty based on the patient's individual levels of upper limb functioning according to the 7 levels of the FTHUE and each level consisted of 5 standardized table-top tasks, but without a mirror. The patients can take a direct view of their paretic hand.
15825248|NCT04242303|Procedure|Total knee replacement|"Total knee arthroplasty using standard anterior approach. In the EM group, inertial sensor will be used to perform femoral bone cuts.
~In the IM group, conventional intramedullary nail will be used as reference to perform femoral bone cuts."
15825249|NCT04242290|Diagnostic Test|Lateral radiography|The lordosis angles were measured on the lateral cervical graphs of all patients.
15825250|NCT04242277|Device|Investigational WF-OCT device|Excised lumpectomy tissue will be imaged on an investigational WF-OCT device
15825251|NCT04242264|Other|Placebo|0.9% Sterile Normal Saline, USP
15825252|NCT04242264|Biological|Shigella sonnei strain 53G|1.5 x 10^3 Colony Forming Units (cfu) Shigella sonnei 53G, a virulent strain of wildtype Shigella sonnei
15825253|NCT04242264|Biological|WRSs2|10^6 Colony Forming Units (cfu) dose of an oral live-attenuated Shigella sonnei vaccine candidate derived from a virulent S. sonnei strain Moseley (WRSs2)-a live, attenuated vaccine that has been manufactured under cGMP conditions at the WRAIR PBF
15825254|NCT04242251|Other|SPARKLE Model of care|Patients will receive the SPARKLE model of care in addition to usual oncologist-led care. The SPARKLE model will be led by a palliative medicine doctor and administered by nurses and staff without specific nursing or medical training. It utilizes a stepped care approach where all patients will initially have low-intensity model focused on weekly symptom monitoring through a patient-reported questionnaire. If any problems are identified, then patients step up to a higher-intensity care model where a nurse will conduct a phone assessment of the symptom problems. If the presence of symptoms is confirmed, patients step up again to an even higher-intensity care model where treatment of symptoms will be initiated by the SPARKLE nurse, depending on the severity of the problems. If the symptoms are not fully resolved, the patients will then step up to the highest-intensity care model which is an existing palliative care service- either palliative care outpatient clinic or home hospice.
15825255|NCT04242238|Drug|DCC-3014|DCC-3014 will be administered in pill form. Start Day 1 on first cycle and continue with dosing of DCC-3014.
15825256|NCT04242238|Drug|Avelumab|Start Day 1 on first cycle with further infusions of avelumab every 14 days
15825257|NCT04242212|Behavioral|Misoprostol sourced from clinics|One cohort of women using misoprostol sourced from clinics
15825258|NCT04242212|Behavioral|Misoprostol sourced from PMVs|One cohort of women using misoprostol sourced from PMVs
15825259|NCT04242199|Drug|INCB099280|INCB099280 administered orally in 25 mg or 100 mg tablets once daily or twice daily on each day of each 28-day cycle
15825260|NCT04242186|Other|Injury Liaison Service|The Injury Liaison Service nurse will coordinate deprescribing of fall-related medications, osteoporosis management, staff support of behavior management using video case conferencing, and shared decision making with residents and/or families.
15825261|NCT04242173|Drug|Cemiplimab-Rwlc|Cemiplimab-rwlc will be administered as a flat dose of 350 mg IV over approximately 30 minutes every 21 days (+/- 3 days)
15825262|NCT04242160|Other|Modified Clamshell Thoracotomy|Participants received standardized training on performing a MCT and LAT. Participants then performed the procedures on a fresh human cadaver model.
15825263|NCT04242160|Other|Left Anterolateral Thoracotomy|Participants received standardized training on performing a MCT and LAT. Participants then performed the procedures on a fresh human cadaver model.
15825264|NCT04242147|Drug|KD033 for Injection|KD033 Monotherapy
15825265|NCT04242134|Device|Drug-coating balloon|Provisional stenting technique with DCB
15825266|NCT04242121|Diagnostic Test|fluorescence flow cytometry|Countification of plasma cells by fluorescence flow cytometry (hematology analyzer XN-1000/20)
15825267|NCT04242108|Diagnostic Test|Deep learning algorithm based on AS-OCT scans|The OCT scans of study subjects would be imported into the algorithm. Automated classfication of angle width and detection of synechia would be performed by the algorithm. The diagnostic performance of the algorithm would be compared with gonioscopy records.
15825268|NCT04242095|Procedure|Biospecimen Collection|Undergo collection of tissue, blood, and stool samples
15825269|NCT04242095|Other|Medical Chart Review|Review of medical records
15825270|NCT04242082|Diagnostic Test|GLUT 1 gene expression|"GLUT 1 gene expression will done on blood samples taken from three groups using real time PCR.
~Pigment epithelium derived factor will used on keratinocytes cell line and compare GLUT 1 gene expression before and after treatment."
15825317|NCT04241692|Device|Conventional 24-Hour 7 Lead Holter Monitor Recorder|Traditional recordings made using a standard 24-hour Holter monitor.
15825432|NCT04240691|Other|Time-and-Attention Control Session|Refer to description under Groups
15825433|NCT04240678|Other|Electronic HBV Alert|Electronic HBV Alert deployed in electronic medical charts of at risk patients
15825271|NCT04242069|Behavioral|Healthy for my Baby|"Participants will start the preconception intervention by meeting with a health professional for a motivational interview session on healthy lifestyle habits. Following this interview, participants will have access to a mobile phone application that will allow them to track daily lifestyle modification goals. After a month, they will meet the health professional for a second motivational interview and review their progression. Participants will continue to make lifestyle changes through the preconception period by accomplishing smart goals followed daily in the mobile phone application.
~If the woman becomes pregnant, the couple will participate in two more in-person motivational interviews, a month apart. The mobile application will be put in pregnancy mode, and participants will adapt their daily lifestyle goals for the pregnancy. Participants will continue to make lifestyle changes throughout pregnancy by accomplishing smart goals followed daily in the mobile phone application."
15825272|NCT04242069|Other|Usual Care|"Participants in the control group will receive standard advice on healthy lifestyle habits as provided by their usual care provider. They will receive standard medical care in preconception and pregnancy.
~To improve compliance with the study follow-up, participants in this group will have access to a simplified version of the mobile application that contains a fertility calendar and a research visit calendar. This version of the application does not include lifestyle goals or any information on healthy lifestyle habits."
15825273|NCT04242056|Drug|18F-PM-PBB3|"18F-PM-PBB3 brain PET studies will be conducted for 38 subjects. Dynamic PET/MRI studies will be collected by PET/MRI scanner for 100 minutes (4×15 s, 8×30 s, 960 s, 2×180 s, 8300 s, 3×600 s). Volumes of interest (VOIs) will be delineated from corresponding MR images by manual including bilateral frontal, parietal, mesial temporal, lateral temporal, hippocampal, occipital, anterior cingulate, posterior cingulate, cerebellum areas, and genu region of white matter. The DVRs will be computed from Logan graphic analysis by using cerebellum as reference input.
~SUVR of every cortical VOI to the gray matter of cerebellum will be calculated from nine 10-min dynamic image sets."
15825274|NCT04242043|Diagnostic Test|intel@med-feasibility|"Initial evaluation by the Nurse using the AI tool which enters into MEDVIR the patient's symptoms or functional complaints and comorbidities and is complemented by a telemedicine solution for data transmission to the remote tele-expert physician located in a regulatory center or health center. The remote doctor (a geriatrician from Prevention Care for Elderly Unit (UPSAV) platform of the Clinical Gerontology Division of the Limoges University Hospital) analyses the data collected by the Nurse and establishes a symptom severity criterion and a diagnosis with the help of the AI technology.
~Both the geriatrician and the NHs nurse are not aware of the proposals made by AI.
~The geriatrician can nevertheless initiate a visit to the resident's place of residence in order to verify the information necessary to establish the diagnosis and thus improve the relevance of the algorithm. For the resident, this study doesn't interfere with the usual care."
15825275|NCT04242030|Other|Moxibustion|"Two sessions of moxibustion will be performed in the Heart meridian and Lung meridian successively.
~Intervention in the Heart meridian: moxibustion will be performed above Shaohai (HT3) for 15 minutes. During moxibustion, the probes of laser doppler flowmetry will detect the microcirculatory characteristics of three measuring sites, which include the midpoint of the Heart meridian along the left forearm, Chize (LU5) of the Lung meridian, and the midpoint of the Lung meridian along the left forearm.
~Intervention in the Lung meridian: moxibustion will be performed above Chize (LU5) for 15 minutes. During moxibustion, the probes of laser doppler flowmetry will detect the microcirculatory characteristics of three measuring sites, which include the midpoint of the Lung meridian along the left forearm, Shaohai (HT3) of the Heart meridian, and the midpoint of the Heart meridian along the left forearm."
15825276|NCT04242030|Device|Laser doppler flowmetry|Laser doppler flowmetry will be used to detect the microcirculatory characteristics of meridian phenomena for the Heart meridian and Lung meridians.
15825277|NCT04242017|Drug|Triptoreline|Comparison of the duration of ADT (Triptoreline)
15825278|NCT04242004|Drug|Docosahexaenoic acid (DHA) capsules|Treatment was provided as 7 omega-3 fatty acid (Lovaza) capsules daily. Each capsule contained 1 g of omega-3 fatty acids with approximately 450 mg of docosahexaenoic acid (DHA).
15825279|NCT04242004|Dietary Supplement|Soy oil capsules|The placebo was identical looking capsules that contained soy oil
15825280|NCT04241991|Radiation|Active laser|Participants will receive laser irradiation on the rectus femoris muscle of both legs immediately before the test (trial 1) and training (trial 2) sessions. A researcher blinded to the treatment conditions will apply the irradiation on eight points distributed over the muscle belly, using a gallium arsenide aluminum (Ga-As-Al) laser (λ: 808 nm) equipment. The points will placed at 25, 35, 50 and 75% of the total distance between the anterior superior iliac spine and superior border of the patella, bilaterally, with 2 cm of distance between each point.
15825281|NCT04241991|Radiation|Placebo laser|Participants will receive placebo irradiation on the rectus femoris muscle of both legs immediately before the test (trial 1) and training (trial 2) sessions. A researcher blinded to the treatment conditions will apply the placebo irradiation on eight points distributed over the muscle belly. The points will placed at 25, 35, 50 and 75% of the total distance between the anterior superior iliac spine and superior border of the patella, bilaterally, with 2 cm of distance between each point.
15825282|NCT04241978|Other|Patient Decision Aid (PtDA)|Patient Decision Aid (PtDA) are tools that enables to promote and facilitate patients' involvement in medical decisions concerning their health
15825283|NCT04241978|Other|Brochure with general information about osteoarthritis|Participants of the control group will be given a brochure with general information about osteoarthritis of the hip, knee, ankle and foot instead of the PtDA
15825284|NCT04241965|Drug|OPC-214870|Tablet(s)
15825285|NCT04241965|Other|Placebo|Tablet(s)
15825286|NCT04241952|Other|Exercise|Bedcycling
15825287|NCT04241939|Behavioral|Numberless BDS|Participants perform daily weighing using a numberless BDS with feedback from app (color codes, challenges), in conjunction with modified motivational interviewing (clinic visits and weekly telephone calls), and the standard adolescent weight loss program.
15825288|NCT04241939|Behavioral|Digital Scale|Participants perform daily weighing using a digital scale (number readout), in conjunction with standard adolescent weight loss program
15825289|NCT04241939|Behavioral|Modified Motivational Interviewing|Modified motivational interviewing (clinic visits and weekly telephone calls), and the standard adolescent weight loss program.
15825290|NCT04241926|Diagnostic Test|transpolmonary thermodilution|Thermodilution was attempted via PICC and via CICC in the same patient
15825291|NCT04241913|Behavioral|Mom Power Intervention|Mom Power is a 10-week therapeutic intervention for at-risk families that incorporates elements of several evidence based practices. It combines didactic material with mindbody self-care skills and in vivo practice to improve the quality of attachment between parent and child, and to reduce the psychopathology of at-risk parents. The child team component provides each child with one-on-one care focusing on meeting the child's social-emotional needs and providing attachment-related experiences within a developmental framework.
15825292|NCT04241900|Behavioral|Shuttle run test|At the shuttle run test, participants were required to run between two lines 20 meters apart, while keeping pace with audio signals emitted from a pre-recorded CD. The frequency of the sound signals increases in such way that running speed was increased by 0.5 km h-1 each minute from the starting speed 8.5 km h-1.
15825293|NCT04241887|Procedure|thoracic paravertebral blockade|Anesthesia was performed under the ultrasound guidance: the Th8 spinous process was identified, then a probe was moved lateral to medial until two adjacent transverse processes and the pleura were visible. After anaesthetising the skin with 2ml of 1% lignocaine (Lignocainum hydrochlorici, WZF 1%), the Touhy needle 22G (Smith Medical)was introduced under the real time guidance. Once in the paravertebral space, 20ml of 0,25% bupivacaine (Bupivacainum hydrochloricum WZF 0,5%, Polfa Warsaw SA) was injected with an end point of a characteristic pleural displacement.
15825294|NCT04241887|Procedure|local anaesthesia|Local infiltration anaesthesia with 0.5% lignocaine 5ml (Lignocainum hydrochlorici, WZF 1%) was applied to the skin and the potential needle path of ablation.
15825295|NCT04241874|Other|Mechanical Ventilation|Respiratory support through mechanical ventilator
15825296|NCT04241861|Other|Respiratory support (High-flow oxygen therapy)|Noninvasive respiratory support respiratory support
15825297|NCT04241861|Other|Respiratory support (Helmet PSV)|Noninvasive respiratory support respiratory support
15825298|NCT04241861|Other|Respiratory support (Helmet CPAP)|Noninvasive respiratory support respiratory support
15825299|NCT04241848|Device|Keeogo|A new and novel type of robotic-device (Keeogo, B-temia, Inc.) was developed to provide powered assistance at the knee for persons with stroke. This device provides assistance for both knee extension and knee flexion during ambulation, transfers to standing and sitting, in addition to ascending and descending stairs. As this device isn't able to fully control the movement, it requires the ability of the patient to stand and initiate stepping. The approach the Keeogo uses to monitor the desired movement in order to appropriately provide assistance. This promotes intuitive learning for the user, minimizing the amount of instruction and practice needed to effectively ambulate allowing users to independently ambulate within one session. This device does not restrict leg movement, so the user can side-step and walk backwards. However, it does not provide assistance during these movements.
15825300|NCT04241848|Other|Ambulation training|Ambulation training will consist of mobility activities affecting daily life including: walking; squatting (or getting in and out of a chair); bending, kneeling or stooping (for picking an item up off of the floor); and ascending and descending stairs. Sessions will be monitored and tailored to the individual, based on their functional ability and to ensure their safety.
15825301|NCT04241835|Drug|Tazemetostat|"200 mg and 400 mg tablets
~Round, red, biconvex, film-coated tablets
~Duration: continuous"
15825302|NCT04241822|Behavioral|Vestibular exercises combined with body awareness exercises and cognitive therapy|The intervention is group based and is a combination of information/education, vestibular exercises (head movements and gaze stability exercises) body awareness exercises and cognitive therapy
15825303|NCT04241822|Behavioral|Exergaming|The intervention consists of different balance exercises using non-immersive virtual reality
15825304|NCT04241809|Diagnostic Test|Bioaerosol Sampling|Cyclone collection of exhaled bioaerosol
15825305|NCT04241796|Device|Multi-Cancer Early Detection Test|Blood collection and multi-cancer early detection testing with return of results.
15825306|NCT04241783|Other|descriptive|correlation
15825307|NCT04241770|Other|no intervention|no intervention
15825308|NCT04241757|Diagnostic Test|ElectroCardioGram (ECG)|Collection of results ElectroCardioGram (ECG).
15825309|NCT04241744|Drug|Vancomycin 125 MG po BID|prevention to develop CDI during hospitalization
15825310|NCT04241731|Drug|Raltitrexed|Raltitrexed 2.5mg / m2, intravenous infusion for 15min, d1,q2w.
15825311|NCT04241731|Drug|Cetuximab|Cetuximab 500mg / kg, intravenous drip over 120min, d1,q2w.
15825312|NCT04241718|Device|Aquadex FlexFlow System and BVA-100|Aquapheresis therapy with Aquadex FlexFlow System and Blood Volume Measurement with BVA-100
15825313|NCT04241705|Other|Treatment of positive individuals per national treatment guidelines|"Treatment for everyone except children <6 months of age, pregnant women, women breastfeeding children <6 months of age, and women 12-49 years of age with an unknown pregnancy status:
~P. falciparum cases: artemether-lumefantrine (AL) plus single dose primaquine (PQ) (0.25mg/kg daily)
~P. vivax cases: chloroquine (CQ) plus 14 days of PQ (0.25mg/kg daily)
~Mixed infections: AL plus 14 days of PQ (0.25mg/kg daily)
~Treatment for pregnant women and women breastfeeding children <6 months of age:
~P. falciparum cases or mixed infections: Quinine (1st trimester); AL (2nd & 3rd trimesters or breastfeeding)
~P. vivax cases: Chloroquine (CQ)"
15825314|NCT04241705|Other|Presumptive treatment with artemether-lumefantrine (AL) plus 14 days of primaquine (PQ)|"Everyone who is eligible for the study except pregnant women and women breastfeeding children <6 months of age AND who are confirmed to have normal G6PD status will be treated presumptively with artemether-lumefantrine (AL) plus 14 days of primaquine (PQ). Treatment will be given without RDT for malaria.
~Women in the first trimester of pregnancy will be treated presumptively with quinine.
~Women in the second and third trimesters or women who are breastfeeding will receive artemether-lumefantrine (AL).
~Again, treatment will be given without RDT for malaria."
15825315|NCT04241705|Other|Optimized malaria control interventions|Optimized malaria control interventions that includes strengthened surveillance systems and commodities management, scale-up of vector control and case management services including follow-up, and social and behavior change communication to seek prompt treatment and use long lasting insecticidal nets (LLINs). Case management includes passive detection of malaria cases and treatment with artemether-lumefantrine (AL) plus single low dose primaquine (PQ) (0.25mg/kg once) for Plasmodium falciparum (Pf) cases and chloroquine (CQ) plus 14 days of PQ (0.25mg/kg daily) for Plasmodium vivax (Pv) cases, and AL plus 14 days of PQ (0.25mg/kg daily) for mixed infections as well as follow-up at the health post or health center on days 3, 7, and 13 for those receiving 14 days of PQ to assess for adverse events and adherence as per the national treatment guidelines.
15825318|NCT04241679|Device|Auditory Nerve Test System|"The Auditory Nerve Test System provides an electrically-evoked signal from within the cochlea to facilitate intraoperative auditory nerve monitoring. The auditory nerve can be measured both at the root entry zone of the brainstem (eCNAP) and with scalp electrodes (eABR). Data on the health of the auditory nerve will be collected immediately prior to tumor dissection, during tumor dissection, and immediately after tumor dissection. The main purpose of this study is to determine feasibility of this novel intraoperative monitoring protocol.
~Secondarily, if the auditory nerve is visually confirmed to be intact following tumor resection then the patients will receive a cochlear implant during the same surgery."
15825319|NCT04241666|Diagnostic Test|renal scintigraphy|Technetium-99m-dimercaptosuccinic acid scintigraphy of both kidneys
15825320|NCT04241666|Diagnostic Test|renal doppler sonography|doppler ultrasound of both kidneys
15825321|NCT04241653|Procedure|Pressure Support Ventilation|Ventilator will be adjusted to administer pressure at 10 cmH2O.
15825322|NCT04241653|Procedure|Unparalyzed Pressure Control Ventilation|Pressure controlled ventilation mode will be applied to obtain a volume of 8 ml/kg up to 20 cmH2O. The set respiratory rate will be 15 breaths/min then it is adjusted to achieve the end tidal CO2 levels between 35 and 40 mmHg as measured by capnography.
15825323|NCT04241653|Procedure|Paralyzed Pressure Control Ventilation|Pressure controlled ventilation mode will be applied to obtain a volume of 8 ml/kg up to 20 cmH2O. The set respiratory rate will be 15 breaths/min then it is adjusted to achieve the end tidal CO2 levels between 35 and 40 mmHg as measured by capnography. Also, neuromuscular blockade will be achieved.
15825324|NCT04241653|Device|Laryngeal Mask Airway|Capnography connected to laryngeal mask airway is introduced after adequate jaw relaxation; its size is chosen according to the body weight of the child.
15825325|NCT04241653|Drug|Sevoflurane|Sevoflurane in air/oxygen mixture of 40% will be titrated to achieve adequate depth of anesthesia to maintain immobilization of the eye.
15825326|NCT04241640|Drug|Nefopam 20 MG/ML|Nefopam group nefopam 20 mg during surgery and follow by 80 mg in 24 hours postoperative
15825327|NCT04241640|Drug|Placebo|Placebo
15825328|NCT04241627|Behavioral|Cell Phone Support|Cell Phone Support includes short phone calls (<5 minutes) made each weekday by a human AF to provide social support, medication reminders, problem-solving coaching, incentives for answering calls, and referrals to other services. Cell Phone Support calls focus on assisting AYAs in identifying and accessing resources and support from their natural environments, such as finding ways they can receive needed help from their families, peers, medical teams, and communities. Live Text Support will deliver the same intervention, by text message.
15825329|NCT04241614|Other|No interventions|No interventions
15825330|NCT04241601|Drug|Interleukin-2 [IL-2]|Active Comparator: IL-2 plays a key role in Treg cell development, expansion, survival and suppressive function
15825331|NCT04241601|Other|Placebo Dextrose 5% solution|Placebo Comparator: Dextrose 5% solution
15825332|NCT04241588|Device|3D Printed Upper-limb Prosthesis|The fingers and thumb were made of polylactic acid polymer manufactured using industrial 3D printers. The palm, socket, forearm brace, and leveraging the structure were made of polylactic acid which has properties similar to thermoplastic that facilitate post-manufacturing adjustments. Elastic cords placed inside the dorsal aspect of the fingers provided passive finger extension. Finger flexion was driven by non-elastic cords along the palmar surface of each finger and was activated through 20-30 degrees of wrist or elbow flexion. The device will be given to participants so that they may practice using the device at home.
15825333|NCT04241575|Diagnostic Test|Simple fibrosis scores and electronic reminder messages|"For patients in the intervention group, we will calculate the fibrosis scores. For patients with increased fibrosis scores, we will type the following pop-up message in our electronic clinical management system:
~This patient has high Fibrosis-4 index (and/or AST-to-platelet ratio index) of xxx suggestive of significant liver fibrosis. Please consider referring the patient to the hepatology clinic or arranging further test such as FibroScan.
~The reminder message will pop up when physicians see the patient at the clinic and use the electronic clinical management system. The message will remain active for one year. Although the message is entered manually at this stage, the arrangement mimics an automated computer system. If the study results are positive, the next step is to modify the system to automate the process."
15825334|NCT04241562|Other|Injection of Nerve Growth Factor|Injection of Nerve Growth Factor to the right masseter
15825335|NCT04241549|Drug|Cusatuzumab|Cusatuzumab at a dose 20 milligram per kilogram (mg/kg) once every 2 weeks will be administered intravenously.
15825336|NCT04241549|Drug|Azacitidine|Azacitidine at a dose 75 milligram per square meters (mg/m^2) will be administered subcutaneously or intravenously.
15825337|NCT04241536|Procedure|Blood draw and urine collection|Patients will collect blood and urine for metabolome analysis
15825338|NCT04241523|Drug|Lenvatinib 4 mg Oral|"Planned doses of 8 mg of lenvatinib per day for patients with body weight <60 kg, and 12 mg for those with body weight ≥60 kg.
~In case of treatment-related adverse effects, interruption or reduction is allowed."
15825339|NCT04241510|Device|Kinesio Taping|Kinesio Taping is a special taping method developed by Dr. Kenzo Kase in 1973. This technique triggers natural healing responses of human body by activating nervous and circulatory systems. The tapes are thin, latex-free, cotton, porous and anti-allergenic, with equal thickness of epidermis. It has elastic properites which allows the tape to elongate to %55-60 of its original lenght. Tape can be used up to 1 week even after sweating or cleaning with water. There are different application techniques for different purposes. Facilitation technique facilitates muscle contractions and supports muscle function. Mechancial correction technique is used for joint positioning and correcting motion of muscle-joint dynamics.
15825340|NCT04241497|Behavioral|Home-based rehabilitation|1 supervised exercise session at the hospital; 3 weeks of supervised home-based exercise training (3x/week); 9 weeks of unsupervised home-based exercise training (3x/week)
15825341|NCT04241484|Device|Piezowave 2|Piezowave Myofascial Acoustic Compression Therapy (MyACT), which provides mechanical stimuli delivery to improve circulation and provide relief of pain. The focused sound waves produced by the Piezowave MyACT device are classified by a pressure surge, which is followed by a drop in pressure and a brief negative pressure phase low energy/low pressure application. It is this transformation of mechanical stimuli into biochemical signals, or mechanotransduction, which yields the treatment of myofascial and musculoskeletal pain
15825342|NCT04241471|Procedure|incision and loop drainage|incision and loop drainage utilizing the rolled ring of a sterile glove technique
15825348|NCT04241419|Behavioral|High Intensity Walking|Participants will then undergo a 12 session intervention, with two sessions scheduled per week for six weeks. These will be 45 minute sessions, including 15 minutes of a warm-up and cool-down period as well as 30 minutes of walking. The intervention will include various types of over ground walking and stair work.
15825349|NCT04241406|Device|Transcutaneous spinal cord stimulation|Electrodes are placed over the back for a 10 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing current intensity during 30 second and decrease intensity subsequentl
15825350|NCT04241393|Drug|Tavapadon tablet|Participants will receive multiple dose titration of Tavapadon (0.25 mg once daily [QD] on Days 1 to 3, 0.5 mg QD on Days 4 to 6, 1.0 mg QD on Days 7 to 9, 1.5 mg QD on Days 10 to 12, and 2.5 mg QD on Days 13 to 15)
15825351|NCT04241393|Drug|Tavapadon [14C] suspension|Following 15-Day multiple dose titration of Tavapadon, participants will receive a single oral dose of Tavapadon 2.5 mg containing approximately 100 μCi of [14C] Tavapadon on Day 16
15825352|NCT04241380|Drug|Anticoagulant Solutions|Patients in this group will received continuous infusion heparin 6 hours postoperatively (initial dose 10 iu/kg/h, dynamic regulation according to ACT 160-180s). After the removal of deep vein catheter, aspirin 5 mg/kg will be given every eight hours subsequently for 3 months.
15825353|NCT04241380|Other|No anticoagulant solutions|They will receive non-coagulant or coagulant treatment according to clinical conditions.
15825354|NCT04241380|Drug|Anticoagulant management|"Continuous infusion heparin (initial dose 10 iu/kg/h and dynamic regulation until the activated coagulation time (ACT) 160-180 s) for a few days.
~Aspirin 5 mg/kg will be given every eight hours subsequently for 3 months."
15825355|NCT04241354|Biological|Leukocyte-poor platelet rich plasma|Platelet rich plasma was prepared using PurePRP Supra Physiologic Protocol A preparation [EmCyte Corp. Fort Myers FL].
15825356|NCT04241341|Procedure|Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction|Axillary Lymph Node Dissection with Immediate Lymphatic Reconstruction
15825357|NCT04241341|Procedure|Axillary Lymph Node Dissection without Immediate Lymphatic Reconstruction|Current standard treatment at Memorial Sloan Kettering [MSK]).
15825358|NCT04241341|Other|quality-of-life questionnaires|Four validated patient reported outcome measures (PROMs): the Upper Limb Lymphedema-27 (ULL-27), the Quality of Life Measure for Limb Lymphedema (LYMQOL), the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Anxiety Inventory (BAI). Study participants will undergo standard lymphedema measurements and quality-of-life questionnaires at baseline before ALND and postoperatively at 6 weeks (+/- 30 days) and at 6, 12, 18, and 24 months (+/- 30 days). If patients are unable to complete their questionnaires at the time of their in-office visit, a link to the questionnaires in REDCap will be emailed to them.
15825359|NCT04241341|Other|measured by arm volume|Bilateral arm volumes will be measured with sequential circumferential measurements with the truncated cone formula.
15825360|NCT04241315|Drug|OTL38 for Injection|Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL
15825361|NCT04241315|Device|Near infrared camera imaging system|Near infrared camera imaging system
15825362|NCT04241302|Diagnostic Test|Pure Tone Audiogram|A Pure Tone Audiogram is done in a sound proof room in both cases of Free Field Voice Test and Free Field Click Tests to identify the Pure Tone Average (Hearing Threshold Average of 500Hz,1000Hz and 2000Hz).
15825363|NCT04241276|Drug|ATRA|45 mg/m2 orally (in two divided doses) from days 1 to 15 of each cycle
15825364|NCT04241276|Drug|Gemcitabine|1000mg/m2 IV on days 1, 8 and 15 of a 28 day cycle
15825365|NCT04241276|Drug|nab-paclitaxel|125mg/m2 IV on days 1, 8 and 15 of a 28 day cycle
15825366|NCT04241263|Device|Wireless vital sign monitoring - comparative|Participants who currently have vital sign monitoring will, in addition, have the wireless system attached. We will then collect up to 24 hours of vital sign data from both systems, which will allow us to make direct comparisons between them.
15825367|NCT04241263|Device|Wireless vital sign monitoring - usability|Babies will be recruited who do not currently require vital sign monitoring. The wireless system will be attached to these babies by nurses who have been trained in its use. A parent will then be asked to perform Kangaroo Care for as long as they feel comfortable. After the baby is placed back in its cot, and the sensors have been removed, we will conduct (separate) interviews with the nurse and the parent on the neonatal intensive care unit (NICU).
15825368|NCT04241250|Device|EAW+SCES (exoskelton and spinal cord epidural stimulation)|Three months of exoskeleton training followed by 6 months of epidural stimulation.
15825369|NCT04241250|Device|EAW+TS (exoskelton and transspinal stimulation)|Three months of exoskeleton training followed by 6 months of transspinal stimulation.
15825370|NCT04241237|Procedure|Blood Draw|Blood will be drawn from each patient to check the concordance between liquid and tissue biopsy
15825372|NCT04241211|Drug|Forsteo|Patients were administered 20mcg of TP (Forsteo) subcutaneously once a day from the day between before 3months to after 3months about surgery.
15825373|NCT04241211|Drug|Denosumab Prefilled Syringe [Prolia]|Patients were administered 60mg of denosumab (Prolia) subcutaneously once 6months from the day on before 3months to after 3months about surgery.
15825383|NCT04241172|Device|Experimental: Immersive Virtual Reality (HIVR)|"the HIVR exercises will be performed using Nirvana system, a medical device based on virtual reality specifically designed to support motor rehabilitation, by projecting aquatic scenarios on the floor that simulates the movement and the noise of the water due to the motor exercise execution by the patient. In particular, the following virtual reality scenarios will be used:
~Swimming pool: the environment represents a swimming pool (water and edge). The patient must perform exercises by moving the lower limbs while sitting on a chair. The virtual environment gives the sensation of having the lower limbs immersed in water above the knees;
~Water metal: the environment gives the feeling of being immersed in water up to the waist. The subject interacts with the virtual water performing walking exercises and receiving a visual and auditory biofeedback."
15825384|NCT04241172|Procedure|Traditional Hydrotherapy (TH)|"The TH group exercises will be performed in a swimming pool suitable for hydrotherapy treatments. In particular, patients will perform:
~exercises with a patients sitting on the swimming pool edge with lower limb immersed in the water;
~flexion-extension of the knee;
~leg and hip circling;
~flexion-extension of the ankle;
~triple flexion;
~water walking exercises."
15825385|NCT04241172|Procedure|Traditional Rehabilitation (TR)|"The TR group exercises will be performed in the gym with a physiotherapist. In particular, patients will perform:
~exercises with a patient sitting on a chair (3 minutes per exercise):
~flexion-extension of the knee;
~leg and hip circling;
~flexion-extension of the ankle;
~triple flexion;
~walking (with and without aids)."
15825386|NCT04241159|Biological|Allogeneic Young Plasma|"The experimental dosing will consist of once weekly administration of PF24 over a period of 8 consecutive weeks (8 total doses over 56 days). 250 mL single units of PF24 will be obtained from the South Texas Blood Bank and processed by the WFBH Blood Bank.
~1 unit (250 mL) PF24, will be infused at 1 mL/kg/hr, once weekly for 8 consecutive weeks."
15825387|NCT04241146|Device|Enteric Tube|A post pyloric feeding tube used in patients requiring enteral nutrition
15825388|NCT04241146|Device|CORTRAK enteral access system|Electromagnetic guidance system for enteric feeding tube placement
15825389|NCT04241133|Behavioral|The UnProcessed Pantry Project (UP3)|UP3 uses the Social-Ecological Model to target multiple levels, including the food supply in the rural study location (community level), the food environment at the food pantry (environmental level), and participant dietary intake (individual level). It is hypothesized that UP3 will improve access to minimally processed foods and decrease access to ultra-processed foods at the food pantry, which will improve overall dietary quality of individuals as measured by the Healthy Eating Index-2015 compared to baseline and to the control group. Demographic and food security data will characterize the population. Psychosocial factors will be collected to understand changes in knowledge, attitudes, and perceptions about processed foods. Biomarkers of health data (i.e., weight, systolic blood pressure, HbA1c, fasting lipid panel) will be collected to determine the feasibility of measuring potential short-term health effects alongside UP3.
15825390|NCT04241120|Behavioral|Device and app system designed for participant to self-administer Habit Reversal Training|Participants will receive an awareness bracelet and an app that work together to implement key features of Habit Reversal Training. The participant will take part in psychoeducation, awareness training, and competing response training related to trichotillomania.
15825391|NCT04241120|Behavioral|Reminder bracelet control condition|Participants will receive a bracelet programmed to vibrate randomly several times per hour during waking hours. They will be instructed this is a reminder not to pull.
15825392|NCT04241107|Procedure|Laparoscopic repair of Uterine niche|Repair of uterine niche through Laparoscopic approach.
15825393|NCT04241107|Procedure|Transvaginal repair of Uterine niche|Repair of uterine niche through Transvaginal approach.
15825394|NCT04241094|Behavioral|Loved one assisted treatment|The investigators propose to bring a loved one into PE, one of the most researched and efficacious treatments for PTSD, to increase support for PE adherence. The intervention is a 13-session cognitive-behavioral, intimate partner-assisted treatment for PTSD that draws from PE, ICBT, and PE2.
15825395|NCT04241081|Behavioral|Interrupting Prolonged Sitting with Periodic Interval Exercise: Effect on Postprandial Lipemia|This is a behavioral intervention designed to determine the effect of breaking up prolonged bouts of sitting every 2 hours and every 6 hours with 5 sets of 4 second bouts of maximum effort bicycle ergometer accelerations compared to sitting alone on the blood triglyceride response and whole body fat oxidation after a high fat meal.
15825396|NCT04241068|Drug|Aducanumab|Administered as specified in the treatment arm.
15825397|NCT04241055|Behavioral|Values affirmation exercise|In the experimental values affirmation condition, participants spend 10-15 minutes completing a guided reflection regarding values that are personally important (see Logel and Cohen, 2012; Brady, Griffiths, & Cohen, in prep).
15825398|NCT04241055|Behavioral|Active control exercise|In the active control condition, participants spend 10-15 minutes completing a guided reflection regarding values that are not personally important but could be important to someone else (see Logel and Cohen, 2012; Brady, Griffiths, & Cohen, in prep).
15825399|NCT04241029|Dietary Supplement|IDOFORM®Travel|Four capsules IDOFORM®Travel orally every 24 hour (12*10^9 cfu/day) for eight weeks.
15825400|NCT04241016|Procedure|Endoscopic sinus surgery (ESS)|Uncinectomy, middle meatal antrostomy by enlarging the natural maxillary ostium and partial ethmoidectomy or septoplasty according to clinical evaluation of the operator.
15825401|NCT04241003|Device|SmartDrive Mx2+|Rear-mounted power assist
15825402|NCT04240990|Other|Development of a score and algorithm for TB treatment decision in hospitalised children with SAM.|"The diagnostic strategy will include an initial clinical, radiographic and bacteriological evaluation of all enrolled children:
~TB contact history
~Suggestive TB symptoms in the previous 4 weeks
~Physical examination
~Clinical, anthropometric and biochemical assessment of malnutrition
~Clinical assessment for other non-dietary causes of malnutrition
~Digitalized CXR
~Ultra performed on NPA and stool samples, and one gastric aspirate (GA)
~Mycobacterial culture performed on two GAs
~Abdominal ultrasonography
~QuantiFERON®-TB Gold IGRA
~Monocyte-to-Lymphocyte Ratio (MLR)
~C-Reactive Protein (CRP)
~TB diagnosis will be made according to national TB guidelines."
15825434|NCT04240665|Behavioral|Digital Memory Notebook (DMN) Application|Subjects will be taught to utilize the DMN application through 2-hour weekly sessions for 6-weeks.
15825435|NCT04240639|Device|AuroShell particle infusion|Infuse AuroShell particles for irradiation by AuroLase laser to ablate neoplasms of the prostate.
15825436|NCT04240626|Drug|Neurontin|600 mg on-call prior to surgery, post surgery 100 mg liquid q 8-12 hours post surgery with Tylenol every 6 hours
15825403|NCT04240977|Behavioral|"HOBSCOTCH: Home-Based Self-Management and Cognitive Training Changes Lives"|Home-Based Self-Management and Cognitive Training Changes Lives (HOBSCOTCH) is a novel phone-based intervention that is enables acquisition of cognitive skills in line with problem solving therapy (PST), and is well suited for PWRE who have failed all other treatment alternatives. Sessions #2 through #7 focus on building patient's awareness for their own day-to-day memory problems, brainstorming, implementing and reviewing the outcomes of potential solutions they generate themselves using the PST framework. In each of these sessions, providers will assist patients in generating alternative solutions, in thinking through what the implementation of each strategy would entail, and in helping them review outcomes for adopted strategies to refine their approach for optimized adoption and generalization.
15825404|NCT04240951|Other|Sweat patch|Flexible, epidermal, wearable skin patch to collect and analyze sweat
15825405|NCT04240938|Procedure|Dacryocystorhinostomy|Anastomosis between lacrimal sac and nasal cavity
15825406|NCT04240925|Device|NIMV with sigh breaths|Sigh breaths: Maximal Inspiratory pressure (IPAPmax) increased of at least 25% ( ≥ 125%) with a frequency of at least 1/200 breaths. The sigh breaths will be delivered as part of the standard NIMV protocol
15825407|NCT04240925|Device|Standard NIMV|Will be treated by standard NIMV with no sigh
15825408|NCT04240912|Device|CompuFlo Epidural Computer Controlled System|"The CompuFlo Epidural Instrument allows the objective identification of the epidural space by pressure measurement at the needle tip and consequently enables the physician to perform epidural anesthesia and epidural injections using standard methods. However, for the purpose of this study the instrument will be used only as a monitor to detect the occurrence of EPW.
~The CompuFlo Epidural Computer Controlled Anesthesia System has received a CE mark in the European Union and it received 510(k) clearance from the FDA in June 2017."
15825409|NCT04240899|Other|Tele-yoga|Subjects will undergo 30-minute yoga sessions delivered remotely 2-3 times/week for 6-weeks. The yoga sessions will be delivered one-on-one and will include 5-7 minutes of breathing exercises 15-20 minutes of postures, and 5-7 minutes of relaxation and meditation exercises.
15825410|NCT04240886|Drug|fosmanogepix|IV and oral fosmanogepix
15825411|NCT04240873|Biological|Catholic MASTER cell|Injection of CATHOLIC MASTER cells 1 x 10^8 cells/DMEM 5cc into knee of patents with osteoarthritis
15825412|NCT04240873|Other|Saline|Injection of saline 5cc into knee of patents with osteoarthritis
15825413|NCT04240860|Biological|platlet rich plasma|"Drug: PRP PRP subendometrial infusion
~Device: ovum oickup needle PRP subendometrial infusion by hysteroscopic guided ovum pickup needle day 9 of the cycle"
15825414|NCT04240860|Procedure|endometrial scratch|Three Snip Hysteroscopic Endometrial Scratching in luteal phase of preceeding cycle
15825415|NCT04240847|Procedure|Skin incision|Skin incision on medial or lateral to tibial tubercle
15825416|NCT04240834|Drug|Aspirin|Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)
15825417|NCT04240834|Drug|Ticagrelor|Comparison of 12 months of ticagrelor and low-dose aspirin versus 12 months of standard dual anti-platelet therapy (DAPT)
15825418|NCT04240821|Drug|Theophylline ER|Oral theophylline
15825419|NCT04240808|Biological|UCD19 CAR T Cells|Lymphodepleting chemotherapy followed by infusion of UCD19 CAR T Cells (Lentiviral Vector [LV] Transduced Autologous Peripheral Blood Lymphocytes)
15825420|NCT04240795|Dietary Supplement|Low lubricity (LL) hydrogels containing fibre-based beads|The preload is made from kappa-carrageenan and alginate beads of 450 μm size. It contains no additional macronutrient but has food-grade watermelon flavor, color, and non-nutritive sweetener.
15825421|NCT04240782|Behavioral|Nutrition and hands on cooking classes for parents and their children|The adults and children will learn how to prepare the fresh produce during an age appropriate, evidence-based, family cooking school. The class will provide participants with a no-cost, low-risk incentive to try new vegetables, and will empower them to build healthier lives through nutrient-rich, locally sourced meals. Participants will also receive nutrition education and information on how they can integrate local produce into their food budget. One of the class sessions will focus solely on how to budget for healthy food, comparison shop, and make the most of their food dollars. Participants will learn how to use their SNAP benefits at local farmers markets.
15825422|NCT04240782|Behavioral|Produce allocations|Participants will also receive a produce allocation from a local farm during each session of the class.
15825423|NCT04240769|Device|Total or Partial Knee Arthroplasty|Reconstruction of part or all of the native articulation at the knee joint via implant.
15825424|NCT04240756|Behavioral|Behavioral Parent Training|Parents will receive 10 sessions of behavioral parent training with components specifically targeted toward parents with ADHD. Treatment will be delivered via telehealth.
15825425|NCT04240756|Drug|Extended release mixed amphetamine salts (MAS)|The MAS protocol will include a 2-4 -week open-label titration beginning at 20 mg and dose level will be increased weekly at telehealth visits with the psychopharmacologist until an optimal response or maximum dose of 60 mg.
15825426|NCT04240743|Device|cephalomedullary nail|For patients in the cephalomedullary nail group, an incision was made in the gluteal area from the tip of the greater trochanter in proximal orientation. A guidewire was placed into the medullary canal from slightly medial to the exact tip of the greater trochanter. The entry point of the greater trochanter and proximal medullary canal were reamed. The cephalomedullary nail was then inserted and fixed to the femoral head with a double screw. The cephalomedullary nail was then locked distally using a guide arm. These cephalomedullary nails were not locked proximally to maintain dynamization and to allow compression across the basicervical fracture line.
15825427|NCT04240743|Device|sliding hip screw|For patients in the sliding hip screw group, a lateral incision was made over the lateral proximal aspect of the femur. Under fluoroscopic guidance, the lag screw was placed centrally in the femoral head over the guidewire. A side plate with three holes was then attached to the hip screw.
15825428|NCT04240730|Procedure|Transvaginal natural orifice endoscopic surgery for endometrial cancer staging|Cases of extreme obese patients with early stage endometrial cancer who underwent v-NOTES
15825429|NCT04240717|Behavioral|Patient Decision Aid|The Patient Decision Aid is an interactive, web-based tool that provides information on advanced melanoma and its treatment options with a strong focus on immunotherapies (i.e. response to therapy, risk of side effects).
15825430|NCT04240704|Drug|JBH492|Anti-CCR7 antibody-drug conjugate (ADC)
15825431|NCT04240691|Behavioral|60-Minutes-For-Health|Refer to description under Groups
15825437|NCT04240626|Drug|Dilaudid Injectable Product|.5-1 mg IV Q3 hours and IV Tylenol 1000mg every 6 hours post surgery transitioning to oral pain control medications (Hycet 7.5/325mg/5 ml, 5-10 ml every 4 hours
15825438|NCT04240626|Drug|Marcaine Injectable Product|0.25% local injectable anesthetic agent infiltrated at all laparoscopic incision sites for both groups.
15825439|NCT04240626|Drug|Oxycodone Hydrochloride|1 mg/ml oral solution, dosage 5-10mg q4h prn for pain control
15825440|NCT04240626|Drug|Hycet 7.5Mg-325Mg/15Ml Solution|Dosage: 10-15ml q4h prn for pain control
15825441|NCT04240626|Drug|Zofran Injection|4 mg IV for nausea control while inpatient, prn
15825442|NCT04240626|Drug|Scopolamine patch|Topical application patch for nausea control, used with/without Ativan.
15825443|NCT04240626|Drug|Ativan|0.5mg IV as needed in conjunction with/without Scopolamine and Zofran for Nausea control
15825444|NCT04240626|Drug|Flexeril Oral Product|5 mg orally q8h prn for muscle spasms.
15825445|NCT04240626|Drug|Tylenol Suspension|1000 mg q6h PRN for pain control.
15825446|NCT04240613|Device|TVT-O|TVT-O is one of the most popular treatments for urinary incontinence (UI). Its efficacy is well established in patients with pure stress urinary incontinence (SUI). Data reporting long-term outcomes of TVT-O for the treatment of mixed urinary incontinence (MUI) or recurrent SUI is scarce. The objective of this study was to evaluate the efficacy and safety and overall patient satisfaction of TVT-O in different subgroups of UI in a long-term follow-up.
15825447|NCT04240600|Dietary Supplement|Experimental group|2 cans or bottles (200ml)per day, orally
15825448|NCT04240600|Dietary Supplement|Control group|2 cans or bottles (200ml)per day, orally
15825449|NCT04240587|Device|TrueTear™ intranasal neurostimulator (ITN)|"The ITN delivers small electrical currents to the inner cavity of the nose, gently activating nerves that stimulate the body's natural tear production system. Those in the ITN active arm will receive the active tips which contain the current from the base to the nasociliary nerve. Those in the ITN sham arm will receive tips without the current."
15825450|NCT04240574|Device|Debritom|hydrosurgery device that utilizes micro water jet technology that has been designed to debride acute and chronic wounds precisely and in a tissue-preserving manner.
15825451|NCT04240561|Device|High level of signal manipulation|Hearing aid will be programmed to a high level of signal manipulation.
15825452|NCT04240561|Device|Low level of signal manipulation|Hearing aid will be programmed to a low level of signal manipulation.
15825453|NCT04240548|Radiation|Regional Nodal Irradiation|
15825454|NCT04240535|Drug|OnabotulinumtoxinA 50 UNT [Botox Cosmetic]|Injections to the Depressor Anguli Oris
15825455|NCT04240509|Drug|Emtricitabine / Tenofovir|Incarcerated men identified at high risk for HIV transmission will be given a 30-day supply of the study drug and will be provided with patient navigation to follow up care upon release.
15825456|NCT04240496|Other|Determination of plasma concentration of clozapine/ Genotyping|Determination of trough plasma concentration of clozapine (C0) Genotyping of CYP1A2 & CYP2C19
15825457|NCT04240483|Other|Intracutaneous sterile water injections (ISWI) group|ISWI consists of 4 intracutaneous injections of 0.5 ml sterile water in the lumbosacral region while patient is in a seated position. One injection given at the posterior superior iliac spine (Point 1) on both sides and second injection at 1 cm medial, and 1-2 cm inferior to the first point on both the sides (Point 2) using an insulin needle. These points overlie the area called Michaelis' rhomboid.
15825458|NCT04240483|Other|Intracutaneous dry injections (IDI) group|Intracutaneous dry injections will be performed in the same manner described above, however, no sterile water or alternative solutions will be injected into the sites.
15825459|NCT04240470|Procedure|Thrombectomy|Participants will receive endovascular treatment (mechanical thrombectomy) alone without using IV rt-PA.
15825460|NCT04240457|Combination Product|Epithelial-on Corneal Crosslinking with the PXL 330 Platinum system.|PXL-330 Platinum device for crosslinking with Peschke riboflavin solution. Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea.
15825461|NCT04240444|Device|drug-coated balloon Catheter|All eligible subjects will be assigned randomly to study group or control group, receive PTCA.
15825462|NCT04240431|Diagnostic Test|Probing /irrigation of lacrimal passages|Probing of the lacrimal passage was done using #00 Bowman's lacrimal probe which can reveal any narrowing (resistance) or obstruction (soft stop) of the canaliculi during its advancement from punctum towards the lacrimal sac.
15825463|NCT04240418|Other|Survey|The objective is to evaluate the eligibility of the responders, as defined by NELSON criteria and PLCOm2012 scoring, and their willingness to participate to a lung-cancer screening with low-dose computed tomography.
15825464|NCT04240392|Behavioral|Collaborative Care (CC)|"The sites randomized to CC will have 4-6 on-site support visits at the outset of the study. These visits will occur during the first 3 months of the project. During these visits, study staff will again review buprenorphine induction procedures (heretofore referred to as initiation rather than induction) and dosing of buprenorphine as well as therapeutic behavioral treatments. The investigators will provide the center with forms and educational materials as well as an app that can be run to help dosing during initiation procedures. At the same time, the investigators will teach obstetricians, nurses and support staff the principles of motivational interviewing. The investigators will set up visits for the CM to meet with a recovery coach trainer provided by the investigators' community partner."
15825465|NCT04240392|Behavioral|Extension for Community Healthcare Outcomes (ECHO)|The Weitzman Institute (WI), a community partner and provider for the ECHO condition, is a research and innovation center focused on improving care for medically underserved and special populations. Since 2013, CHCI/WI has provided education and technical assistance through an established video conference and online learning platforms to over 800 primary care providers and over 200 care team members who treat patients with chronic pain and opioid addiction. WI partners with national experts in pain care, substance abuse disorder, and MAT to create and deliver a robust training program for clinicians across the country through Project ECHO ®. The WI will work with the study team to develop and staff the sessions.
15825466|NCT04240366|Procedure|Control intervention|patients treated with balloon-based ablation of AF by PVI
15825467|NCT04240366|Procedure|Experimental intervention|patients treated with balloon-based ablation of AF by PVI
15825468|NCT04240353|Other|COPD digital support service|Use of COPD digital services to record patient symptoms, integrate physiology monitoring, communicate with the clinical team and track interaction
15825469|NCT04240340|Other|semi-structured interview|Semi-structured, face-to-face interviews will be carried out with participants.
15825470|NCT04240314|Biological|scAAV9.U7.ACCA|A single dose of scAAV9.U7.ACCA will be systemically delivered via a peripheral vein injection.
15825473|NCT04240275|Device|Reliability of the G-Walk device in children with Cerebral Palsy|"The purpose of this study was to confirm the test-retest reliability of a commercially available body-worn sensor-G-Walk® sensor system-for spatiotemporal gait parameters in children with CP.
~The children will be assessed with the G-Walk on two separate occasions.For the reliability analysis, the second measurement tests will be repeated 3 days after the first assessment.
~The device is placed on an elastic belt and worn on the waist of the person being evaluated, with the center of the device at the fifth lumbar vertebrae. To ensure correct placement of the device, the L4-L5 intervertebral space will be palpated via the posterior superior iliac spines (SIPS).
~After the accelerometer is placed, the children are asked to walk calmly at normal speed, on a 10 m track, whose boundaries will be determined with colored lines and to return to the starting position."
15825474|NCT04240249|Behavioral|Constructive self-assertiveness program via the internet|"Participants will get one chapter a week to work with. All chapters are presented on web pages and include information and exercises and end with homework assignments."
15825475|NCT04240236|Procedure|Scalp block|Patients will be randomly divided into two groups using a computer generated random number chart. Group S received scalp block with 20 ml of 0.5% bupivacaine, whereas Group C will not receive any intervention and will be considered as control group.
15825476|NCT04240236|Other|Control Group|Patients will be randomly divided into two groups using a computer generated random number chart. Group S received scalp block with 20 ml of 0.5% bupivacaine, whereas Group C will not receive any intervention and will be considered as control group.
15825477|NCT04240223|Drug|Brilacidin|Brilacidin
15825478|NCT04240223|Drug|Placebo|Placebo
15825479|NCT04240223|Radiation|4Mq 99mTc-DTPA|4Mq technetium-99m (99mTc), complexed with diethylenetriaminepentaacetic acid (DTPA) which prevents absorption of the radioisotope from the gastrointestinal tract
15825480|NCT04240210|Drug|Symtuza|The study is a prospective cohort analysis of change in adherence, tolerability and safety of subjects who reports poor adherence to ART due to intolerance/side effects from integrase inhibitor containing regimens when they are switched to DRV/COB/FTC/TAF and monitored for 4 months.
15825481|NCT04240197|Device|CompuFlo|The occurrence of epidural pulse waves with CompuFlo and with standard pressure trnsducer
15825482|NCT04240184|Other|Physical workload|Cohort study - The specific study aims are to investigate 1) exposure-response associations between quantity of occupational lifting and short-term (day-to-day) changes in LBP, 2) the influence of accumulated workdays and rest days during a working week on LBP, 3) long-term association between occupational lifting exposure and LBP when assessed over 1 year, and 4) the role of psychological and social factors on the above associations.
15825483|NCT04240171|Drug|Dapagliflozin 5Mg Tab|Dapagliflozin 5mg tablets daily
15825484|NCT04240171|Drug|Glimepiride 4Mg Tab|Glimepiride Tablets daily
15825485|NCT04240158|Drug|IW-6463|IW-6463 Tablet
15825486|NCT04240158|Drug|Matching Placebo|Matching Placebo Tablet
15825487|NCT04240145|Device|MSCT Abdomen|Visceral fat volumetry using MSCT and it's relation to NASH
15825488|NCT04240132|Other|Adherence to Hand Hygiene|determine the colonization of microorganisms due to microbial reproduction on the external surface of the distal end of the enteral feeding tube (EFT), hub of the EFT and other feeding system components and assess the relation between the colonization and adherence to hand hygiene practices by nurses and other healthcare workers
15825489|NCT04240119|Other|According to current clinical care standards|Enrolled subjects may be treated with medical management or surgically using indirect revascularization surgery.
15825490|NCT04240106|Drug|Niraparib 100 MG|Niraparib 200 or 300 mg daily (orally) beginning on Day 1 and continuing through Day 28 of every 28-day cycle.
15825491|NCT04240106|Drug|Aromatase Inhibitors|Aromatase Inhibitors beginning on Day 1 and continuing through Day 28 of every 28-day cycle.
15825492|NCT04240093|Behavioral|Behavioral Activation (BA) Therapy|8 sessions of behavioral activation therapy
15825493|NCT04240093|Behavioral|Substance Abuse and Health Navigation Counseling|2 standard substance abuse and health navigation counseling
15825494|NCT04240093|Other|Medications for Opioid Use Disorder|Medications for opioid use disorder (i.e., buprenorphine and methadone) as prescribed by a community provider (not provided as part of the study).
15825495|NCT04240080|Device|Accuvein® Veinfinder|Near-infrared light reflection utilized by healthcare providers to see superficial veins under the skin.
15825496|NCT04240067|Diagnostic Test|READ-MA Multimarker Approach|The presence or absence of ALSHF (gold standard used in the READ study) : diagnosis by 2 experts (cardiologist and emergency physician) based on data collected in the ED and during hospitalization (clinical examination, history, usual treatment, haemodynamic parameters, ECG, chest X-ray, emergency treatment, clinical and paraclinical results during hospitalization), biological assays (except NT-proBNP) and echocardiography (Left Ventricular Ejection Fraction, segmental kinetic, potential valvulopathy, transmitral flow, tissue doppler E' velocity) performed by a cardiologist within 24 hours of admission.
15825497|NCT04240054|Drug|Bortezomib|Bortezomib (1.5 mg/m^2) subcutaneous on days 1, 8 and 15
15825498|NCT04240054|Drug|Isatuximab|Isatuximab (10 mg/kg) IV on days 1, 8, 15 and 22
15825499|NCT04240054|Drug|Cyclophosphamide|Cyclophosphamide (250 mg/m^2) IV on days 1, 8 and 15
15825500|NCT04240054|Drug|Dexamethasone|Dexamethasone 20 mg PO or IV (10 mg if >75 years) on days 1, 2, 8, 9, 15, 16, 22 and 23
15825501|NCT04240041|Diagnostic Test|Transcerebellar diamater|Using SAMSUNG H60 convex probe 2-8 MHz Machine by the same sonographer, trans-cerebellar diameter is identified by obtaining an oblique view through posterior fossa that included visualization of midline thalamus, cerebellar hemispheres and cisterna magna.
15825502|NCT04240041|Diagnostic Test|Placental thickness|Using SAMSUNG H60 convex probe 2-8 MHz Machine by the same sonographer, placental thickness will be measured at the level of the umbilical cord insertion excluding the myometrium and sub-placental veins
15825503|NCT04240028|Other|Data Collection|The NuAge study has been designed to investigate nutrition as a determinant of successful aging in older men and women in Quebec. This study is based on a population-based observational cohort design that initially recruited healthy community-dwellers with age ranged from 67 to 82 years (51.8% women) between January 2004 and April 2005. All participants lived in the areas of Montreal, Laval, and Sherbrooke in the Province of Quebec, Canada. After recruitment, they have been followed for 3 years with one clinical follow-up assessment each year (i.e.; 4 data collection time). A previous analysis performed on the NuAge study database has shown a significant decline of physical and cognitive performances with time (respectively an average of 10% and 2%), participants with lower physical performance showing lower cognitive performance.
15825504|NCT04240015|Other|Oral-Dental Health-Related Quality of Life-United Kingdom (OHRQoL-UK) scale|It consists of 4 different categories and 16 questions evaluating the effects of OHRQoL in positive and negative areas. These categories are as follows; symptoms (2 questions), physical status (5 questions), psychological status (5 questions), social status (4 questions) ' Questions on the OHRQoL-UK scale were scored using the Likert-type scale as 'very bad effect-score 1, bad effect-score 2, no effect-score 3, good effect-score 4, very good effect-score 5. The scores obtained from all questions were summed to give the scores of the 4 sub-categories separately and the total OHRQoL score. A higher total score indicates a higher OHRQoL.
15825505|NCT04240002|Drug|gilteritinib|Administered orally.
15825506|NCT04240002|Drug|fludarabine|Administered by intravenous (IV) infusion
15825507|NCT04240002|Drug|cytarabine|Administered by intravenous (IV) infusion
15825508|NCT04240002|Drug|granulocyte colony-stimulating factor (G-CSF)|Administered by subcutaneous injection
15825509|NCT04239989|Drug|Itacitinib|Given PO
15825510|NCT04239989|Drug|Itacitinib Adipate|Given PO
15825511|NCT04239976|Device|FitBit|Wear FitBit for gait assessment test
15825512|NCT04239976|Other|Gait Assessment Test|Undergo gait assessment test
15825513|NCT04239976|Other|MC5-A Scrambler Therapy|Undergo scrambler therapy
15825514|NCT04239976|Other|Quality-of-Life Assessment|Ancillary studies
15825515|NCT04239976|Procedure|Quantitative Sensory Testing|Undergo quantitative sensory test
15825516|NCT04239976|Other|Questionnaire Administration|Ancillary studies
15825517|NCT04239950|Drug|Placebo|Placebo
15825518|NCT04239950|Drug|Ethyl Icosapentate|Ethyl Icosapentate
15825519|NCT04239924|Behavioral|Paramedic Coaching|The intervention is an adaptation of the evidence-based REACH program, specific coaching content is delivered by paramedics in 1-2 hour in-home sessions and over the phone throughout a 12-month period.
15825520|NCT04239911|Behavioral|Electronic tablet|The electronic tablet will provide heart failure-specific education to home health aides and allow them to report clinical observations and ask nurses questions in real-time.
15825521|NCT04239911|Behavioral|Training course|Training course on heart failure for home health aides
15825522|NCT04239898|Other|Red cabbage microgreens|2 cups per day
15825523|NCT04239898|Other|Red beet microgreens|2 cups per day
15825524|NCT04239872|Drug|Fluoride mouthwash|Sodium fluoride, at a concentration of 0.05% (226 parts per million (ppm) of fluoride), will be used to rinse the mouth for 1 minute and expectorated.
15825525|NCT04239872|Drug|Calcium and fluoride mouthwash|Calcium lactate, at a concentration of 150 milimolar, will be used to rinse the mouth for 1 minute and expectorated; immediately after, a sodium fluoride rinse, at a concentration of 0.05% (226 ppm of fluoride), will be used to rinse the mouth for 1 minute, and expectorated.
15825526|NCT04239859|Biological|secukinumab|Secukinumab for 6 months, given at weeks 0, 1, 2, 3 and 4, then monthly till 6 months. 300mg per administration, subcutaneously.
15825527|NCT04239859|Drug|Methotrexate|Oral tablet up to 15mg per week
15825528|NCT04239859|Drug|Cyclosporin A|Oral capsule up to 200mg per day
15825529|NCT04239859|Drug|Acitretin|Oral capsule up to 25mg per day
15825530|NCT04239846|Drug|AC-701 Topical Gel 0.3%|AC-701 Topical Gel 0.3%, BID
15825531|NCT04239846|Other|Placebo Gel|Placebo Gel, BID
15825532|NCT04239833|Drug|SH-1028 tablets|"The initial dose of SH-1028 tablets is 200 mg once daily . A cycle of treatment is defined as 21 days of once daily treatment.
~Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria."
15825533|NCT04239833|Drug|Placebo SH-1028 tablets|"The initial dose of Placebo SH-1028 tablets is 200 mg once daily . A cycle of treatment is defined as 21 days of once daily treatment.
~Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria."
15825534|NCT04239833|Drug|Gefitinib|"The initial dose of Gefitinib is 250 mg once daily . A cycle of treatment is defined as 21 days of once daily treatment.
~Following objective disease progression according to RECIST 1.1, as per investigator assessment, patients who were randomized to Standard of Care arm may have the option to receive open-label SH-1028 tablets (crossover to active SH-1028 tablets)."
15825535|NCT04239833|Drug|Placebo Gefitinib|The initial dose of Gefitinib is 250 mg once daily . A cycle of treatment is defined as 21 days of once daily treatment.
15825536|NCT04239820|Radiation|Imaging|MRI and TSPO-PET imaging at baseline and 18 months after baseline
15825537|NCT04239807|Device|Group 1 GALILEO WBV|3 month home based WBV training
15825538|NCT04239807|Other|Group 2 Control|Training on the floor without WBV
15825539|NCT04239794|Drug|Propofol|General anesthesia during the laparoscopic colorectal surgery is achieved by using a target-controlled intravenous infusion of propofol.
15825540|NCT04239794|Drug|Sevoflurane|General anesthesia during the laparoscopic colorectal surgery is achieved by using an inhalation agent (Sevoflurane).
15825541|NCT04239768|Device|MonoDermà HA gel combined to a low level laser|"Two intradermal injections of the filler were performed during the basal and after 1 month, on the middle and inferior third of the face (1ml for each face side) using a needle (30G).
~Immediately after both injection procedures, LLLT session were performed on the same face area for a total of 8 minutes, using three different wavelengths (450 nm, 650 nm and 1064 nm) simultaneously."
15825542|NCT04239755|Drug|Doxycycline 100 MG Oral Tablet|doxycycline 100 mg twice daily, either orally or through a nasogastric tube for 5 day
15825543|NCT04239755|Other|placebo|placebo in addition to the standard treatment.
15825544|NCT04239742|Diagnostic Test|F18-fluciclovine PET/CT|370 MBq ±10% 18F-Fluciclovin + low-dose CT scan, from skull base to pelvis.
15825545|NCT04239742|Diagnostic Test|F18-PSMA-1007 PET/CT|4 MBq/kg ±10% F18-PSMA + low-dose CT scan, from skull base to pelvis
15825546|NCT04239729|Behavioral|ACT Website and Coaching|The ACT website includes sixteen sessions and is designed to teach a series of skills from ACT applied to hoarding. The intervention also includes brief supportive coaching (an initial phone call and weekly support over email).
15825548|NCT04239703|Diagnostic Test|MMDx|Portion of kidney transplant indication biopsy
15825549|NCT04239703|Diagnostic Test|Prospera|Transplant patient blood sample
15825550|NCT04239703|Diagnostic Test|HLA antibody|Transplant patient blood sample
15825551|NCT04239690|Other|Micromethods for blood sample analysis|Micromethods in the intervention arm are applied aiming to achieve a mean reduction of 50 % of sampled blood volume during the first two postnatal weeks as compared to standard clinical blood sampling analyses
15825552|NCT04239677|Procedure|Conventional crystalloid solution-based priming|CPB circuit is also prepared with crystalloid solution-based priming in all participants (same as the RAP group). In this group (control group), CPB is initiated with antegrade priming (conventional priming).
15825553|NCT04239677|Procedure|Retrograde autologous priming|CPB circuit is prepared with crystalloid solution-based priming in all participants. In RAP group, retrograde autologous priming is performed by displacing the crystalloid priming volume of arterial and venous lines via passive exsanguination of native blood prior to CPB initiation.
15825554|NCT04239664|Other|Acceptance Based Telephone Support (ABS+UC)|Support based on Acceptance and Committment Therapy (Hayes, 1999)
15825555|NCT04239651|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|rTMS uses powerful (1.0-2.5 Tesla), focused magnetic field pulses to induce electrical currents in neural tissue noninvasively, via an inductor coil placed against the scalp.
15825556|NCT04239651|Other|Internet-Delivered Cognitive Behavior Therapy (iCBT)|Cognitive behavioral therapy (CBT) is an evidence-based, structured, intensive, time-limited, symptom-focused form of psychotherapy recommended for the treatment of major depression and anxiety disorders. Internet-delivered CBT (iCBT) is structured CBT delivered via the internet.
15825557|NCT04239638|Diagnostic Test|Cervical Spinal MRI|Cervical Spinal MRI images of 500 patients will be entered into the system for modeling
15825558|NCT04239625|Drug|ALK-001|Oral administration of a pill for up to 24 months
15825559|NCT04239612|Behavioral|Physical exercise|Regular physical exercise in groups. Circular training: both strength and fitness
15825560|NCT04239599|Radiation|Hypofractionated IMRT Radiation treatment|
15825561|NCT04239586|Drug|Sulfonylurea|Starting treatment with sulfonylurea class of drug
15825562|NCT04239573|Procedure|Computed Tomography|Undergo CT
15825563|NCT04239573|Procedure|Endoscopic Ultrasound|Undergo EUS
15825564|NCT04239573|Procedure|Magnetic Resonance Imaging|Undergo MRI
15825565|NCT04239573|Other|Quality-of-Life Assessment|Ancillary studies
15825566|NCT04239573|Other|Questionnaire Administration|Ancillary studies
15825567|NCT04239560|Drug|Boron-based Gel (Fibore)|During each radiotherapy session, 15 minutes before radiotherapy, the gel used and patients followed up.
15825568|NCT04239560|Drug|Placebos|During each radiotherapy session, 15 minutes before radiotherapy, the Placebo gel which be free of any chemical used and patients followed up.
15825569|NCT04239547|Procedure|Alveolar Recruitment maneuver (ARM) +PEEP|Following anesthesia induction and intubation, alveolar recruitment maneuver followed by 5 mmHg PEEP
15825570|NCT04239547|Procedure|PEEP|Following anesthesia induction and intubation, only 5 mmHg PEEP
15825571|NCT04239534|Device|Convergence Of Epicardial And Endocardial RF Ablation|The epicardial lesion pattern will be created using the EPi-Sense®-AF Guided Coagulation System with VisiTrax®. Epicardial linear lesions will be created endoscopically using the EPi-Sense-AF Guided Coagulation System with VisiTrax throughout the posterior left atrium and along the pericardial reflections from a trans-diaphragmatic or sub-xyphoid access without any chest incisions. An endocardial ablation catheter will be used to ablate endocardially to connect lesions at the reflections, complete the isolation of the pulmonary veins and create a cavotricuspid lesion to prevent typical atrial flutter. Once the study lesion pattern has been created by coagulating cardiac tissue using the EPi- Sense-AF Guided Coagulation System and the endocardial ablation catheter, the pulmonary veins must be evaluated for entrance and/or exit block to confirm isolation.
15825572|NCT04239521|Other|Exposure of interest (studies 2 & 3).|Common mental health conditions consist of depressive episodes, recurrent depressive disorder and anxiety disorder Atopic conditions consist of Atopic dermatitis, allergic rhinitis, asthma Autoimmune conditions consist of Crohn's disease, ulcerative colitis, Coeliac disease, Pernicious anaemia, Type 1 diabetes, Hashimoto's thyroiditis, Grave's disease, Rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Systemic lupus erythematosus, polymyalgia rheumatica, Sjögren's syndrome, Psoriasis, vitiligo, Multiple sclerosis
15825573|NCT04239495|Other|Observational study: range of clinical and lifestyle factors|Medical conditions and medications. Educational and occupational history. Lifestyle exposures, assessed using reduced Food Frequency Questionnaire, Rapid Assessment of Physical Activity questionnaire and objectively-measured physical activity levels over 7 days using a GeneActiv wrist-worn accelerometer (Activinsights, Cambridge, UK).
15825574|NCT04239482|Dietary Supplement|L-arginine + Nitrate / Nitrite|Longer-term supplementation (8 weeks)
15825575|NCT04239482|Dietary Supplement|Placebo|Longer-term supplementation (8 weeks)
15825576|NCT04239469|Drug|KL16-012|Standardized cannabis sativa extract of THC and CBD, with each drop containing 1 mg of THC and 0.45 mg of CBD
15825577|NCT04239469|Drug|Placebo|Placebo
15825578|NCT04239456|Device|RehaCom (software)|RehaCom software has gamified, interactive modules that will help participants practice the application of various memory strategies at custom, increasingly more difficult levels. Instructor will also use the software to teach and demonstrate the use of memory strategies with the domains targeted (i.e., list learning, remembering written/verbal information, and memory for names/faces).
15825579|NCT04239443|Drug|PD-1 inhibitor|Intravenous administration of SHR1210 (200mg/2weeks or 200mg/3weeks)
15825580|NCT04239443|Drug|Apatinib|NSCLC and Uterine cancer will be given oral of Apatinib (250mg/d), soft tissue sarcoma will be given oral of Apatinib (500mg/d).
15825581|NCT04239430|Diagnostic Test|Serum Bactericidal Assays|Blood samples will be taken from participants at two time points in the study. Serum Bactericidal Assays from participant serum using relevant MenB and MenACWY strains will be undertaken at 12 and 24 months post two doses of 4CMenB (Bexsero, GSK) and MenACWY-conjugate (Menveo, GSK) vaccine. The Vaccines were given to participants during an earlier clinical trial (Propositive). This trisal is a follow up study.
15825582|NCT04239417|Other|Graduated abdominal strengthening exercises|"Exercise mat and inflatable Swiss ball
~Wall bar, wedges, elastic tubing"
15825583|NCT04239417|Device|The Russian current stimulation|The Russian current is used for enhancing muscle; the muscular fiber by the electric stimulation.
15825584|NCT04239417|Combination Product|Graduated abdominal strengthening exercises and the Russian current stimulation|Combination between The Russian current and abdominal exercises
15825585|NCT04239391|Drug|Triferic|Ferric Pyrophosphate Citrate
15825586|NCT04239378|Procedure|socket preservation|Autogenous dentin matrix and collagen membrane(test group) Bovine derived xenograft and collagen membrane (control group)
15825587|NCT04239365|Diagnostic Test|WLE followed by NBI or NBI followed by WLE (crossover design)|EMR scar is inspected using WLE followed by NBI or vice versa
15825588|NCT04239352|Diagnostic Test|Pentraxin 3 ; new biomarker|"Pentraxin (PTX3) is an inflammatory molecule that belongs to a recently identified, well-known C-reactive protein (CRP) family.
~PTX3 plasma levels increase in vascular disorders including myocardial infarction and correlate with small vessel vasculitis and outcome or disease activity.
~These biological and clinical features of PTX3 have led us to investigate this molecule in preeclampsia, a syndrome characterized by a prominent vascular component."
15825589|NCT04239352|Diagnostic Test|Lipoprotein-associated phospholipase A2 ; new biomarker|Lp-PLA2 is a recently described and potentially useful plasma biomarker associated with cardiovascular diseases. Because of this effect, we will investigate that preeclampsia also be beneficial.
15825590|NCT04239339|Drug|Escitalopram 20 mg|20mg daily for approximately 3 weeks.
15825591|NCT04239339|Drug|Placebo|Placebo daily for approximately 3 weeks.
15825592|NCT04239326|Diagnostic Test|targeted Next Generation Sequencing (tNGS)|The index tests used in this trial will include up to three end-to-end, targeted next generation sequencing (tNGS) solutions for diagnosis of DR-TB. Each solution will include all of the equipment, reagents, and software necessary for handling the entire sequencing workflow, including DNA extraction from processed sputum samples (i.e. sediment), library preparation, sequencing, and data analysis/interpretation for clinical result reporting.
15825593|NCT04239313|Biological|Low-dose freeze-dried recombinant tuberculosis vaccine (AEC / BC02)|Population I are coxal muscle injection of low dose vaccine.
15825594|NCT04239313|Biological|Low-dose adjuvant for freeze-dried recombinant tuberculosis vaccine (AEC / BC02)|Population I are coxal muscle injection of low dose adjuvant.
15825595|NCT04239313|Biological|Lyophilized recombinant tuberculosis vaccine (AEC / BC02) placebo|The placebo drug contains 20mg mannitol and 10 millimole(mM) phosphate buffer(PB).population I are coxal muscle injection of placebo.
15825596|NCT04239300|Behavioral|Delivery in water|Participants delivery in water
15825597|NCT04239287|Diagnostic Test|Lung function + exercise tests|Lung function + exercise tests
15825598|NCT04239274|Device|transcranial direct current stimulation|Subjects in this arm will receive one session of tDCS for 20 minutes at 2.0 milliamps.
15825599|NCT04239274|Device|transcranial pulsed current stimulation|Subjects in this arm will receive one session of tPCS for 20 minutes at 2.0 milliamps.
15825600|NCT04239274|Device|Sham-no stimulation|Subjects in this arm will receive one session of sham for 20 minutes.
15825601|NCT04239261|Dietary Supplement|SBI|Serum-derived Bovine immunoglobulin/protein isolate 10.0 g once daily
15825602|NCT04239261|Dietary Supplement|Placebo|Hydrolyzed gelatin 10.0 g once daily
15825603|NCT04239248|Dietary Supplement|Tasty&Healthy intervention group|"patients will receive dietary advice to exclude pro-inflammatory dietary components based on the book Tasty&Healthy."
15825604|NCT04239248|Dietary Supplement|EEN intervention group|Oral exclusive feeding of formulated food (EEN), using Modulen formula only, for 8 weeks in amount based on the Daily Recommendations Intake. Those not tolerating oral EEN can receive EEN via a nasogastric tube.
15825605|NCT04239235|Behavioral|CRAFT|CRAFT is an evidence-based and non-confrontational approach for teaching friends/family members strategies to help their loved one reduce/refrain from using substances. It focuses on improving the lives of both the friends/family members and the individual struggling with substance use.
15825606|NCT04239222|Device|Revo-M|Investigational energy storage and return prosthetic foot with using novel elastic elements.
15825607|NCT04239222|Device|Taleo|Commercially available carbon-fiber energy storage and return foot used as comparative foot for transfemoral amputee subjects
15825608|NCT04239222|Device|Proflex XC|Commercially available carbon-fiber energy storage and return foot used as comparative foot for transtibial amputee subjects
15825609|NCT04239209|Behavioral|Indirect - other patients|Video depicting an indirect response focusing on a comparison to other patients.
15825610|NCT04239209|Behavioral|Indirect - physiology|Video of an indirect response focusing on the physiology of the patient.
15825611|NCT04239209|Behavioral|Redirection|Video of a redirection towards discussing the patient's values and possible future decisions.
15825612|NCT04239209|Behavioral|Direct communication|Video of a direct response.
15825613|NCT04239196|Drug|tocilizumab and IV steroids combination|"Every patient will receive the reference treatment for GCA with ocular complication, i.e. high dose corticosteroid therapy (with intravenous pulses of 1000 mg/day of methylprednisolone for 3 days followed by oral prednisone at 1 mg/kg/day with progressive decrease) and aspirin 75 mg/day. The mean duration of this reference treatment is 18 months.
~Patients will receive in addition to the reference treatment four subcutaneous injections of tocilizumab 162 mg over one month (1 injection per week)."
15825614|NCT04239196|Other|IV steroids combination alone|Every patient will receive the reference treatment for GCA with ocular complication, i.e. high dose corticosteroid therapy (with intravenous pulses of 1000 mg/day of methylprednisolone for 3 days followed by oral prednisone at 1 mg/kg/day with progressive decrease) and aspirin 75 mg/day. The mean duration of this reference treatment is 18 months.
15825615|NCT04239183|Device|Stomatherapy|Demonstrate improvement of quality of life (difference of at least 5 points in the StomaQoL questionnaire (21)) among descending colostomy patients, establishing the following comparisons.
15825616|NCT04239170|Drug|Camrelizumab(SHR-1210)|Camrelizumab(SHR-1210): A humanized monoclonal immunoglobulin
15825617|NCT04239157|Biological|Canakinumab|Given SC
15825618|NCT04239144|Procedure|Left trunk sympathectomy|left truck sympathectomy will be performed using video assisted thoracoscopy using the Ethicon Ultracision device. The denervation consisted of left lower 1/3 stellate ganglion and T3- T4 thoracic interspinal space videothoracoscopic cutting, isolating the whole sympathetic chain between these two points using ultracision device on the nerve branches. The cephalic portion of the stellate ganglion was preserved to avoid Horner's syndrome and the electrocautery use was also avoided due to the same reason. The nerve was blocked using Ultracision device to avoid thermic lesion of the stellate ganglion. Hemodynamic and echocardiographic behaviors were continuously monitored during these surgical maneuvers.
15825619|NCT04239144|Procedure|Catheter ablation|Catheter ablation - patients allocated to this group will undergone epicardial and endocardial catheter ablation with the use of irrigated contact sensor tip catheter. Voltage electroanatomical mapping using Carto System will be performed in all cases and if hemodynamically stable VT is induced activation mapping will also be performed. The aim of the ablation is to eliminate the clinical VT additionally to substrate modification. The result of ablation will be defined as (1) complete success; (2) partial success and (3) failure.
15825620|NCT04239131|Other|Skin prick test|a Skin prick test is planned in all patients
15825621|NCT04239118|Combination Product|Complex endoscopic treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets|Complex endoscopic bleeding ulcers treatment with the use of granular sorbent aseptisorb-A and autoplasm enriched with platelets
15825622|NCT04239118|Procedure|Traditional methods of endoscopic hemostasis|Traditional methods of endoscopic hemostasis were used without the use of platelet-enriched plasma and granular sorbents
15825623|NCT04239105|Device|Microfluidic and Raman spectrum|Detection of Circulating Tumor Cells
15825624|NCT04239092|Drug|9-ING-41|9-ING-41 will be administered by intravenous infusion twice weekly at an initial dose of 9.3 mg/kg. Cycle duration is 21 days.
15825625|NCT04239092|Drug|Irinotecan|Irinotecan 50 mg/m2/day administered over 90 minutes IV on days 1-5 every 21 days.
15825626|NCT04239092|Drug|Temozolomide|Temozolomide will be administered at a dose of 100 mg/m2/dose by mouth on Days 1 through 5 of a 21 day cycle.
15825627|NCT04239092|Drug|Cyclophosphamide|Cyclophosphamide 400 mg/m2/dose administered intravenously over 30 min on Days 1 through 5 of a 21 day cycle.
15825628|NCT04239092|Drug|Topotecan|Topotecan 1.2 mg/m2/dose administered intravenously over 30 min once on Days 1 through 5 of a 21 day cycle.
15825629|NCT04239066|Procedure|Tourniquet|tubularized incided plate (TIP) urethroplasty plus tourniquet
15825630|NCT04239066|Procedure|Non-tourniquet|tubularized incided plate (TIP) urethroplasty plus non-tourniquet
15825631|NCT04239053|Drug|Bupivacaine|Measuring the plasma concentration level of bupivacaine after applying ESPB
15825632|NCT04239040|Procedure|Tissue collection|Collection of cancerous tissue to create GVAX vaccine or irradiated GMCSF-secreting autologous neuroblastoma cell vaccine at time of clinically indicated surgical procedure
15825633|NCT04239040|Biological|GVAX vaccine|Vaccine injected weekly over initial 21 day cycle, biweekly for cycles 2-4 of 21 day cycle duration and cycles 5 and subsequent of 28 day cycle duration until vaccine supply is exhausted.
15825634|NCT04239040|Drug|Nivolumab|"Intravenous infusion of nivolumab every 3 weeks, for cycles 1-4. Cycles 1-4 are 21 days
~Intravenous infusion of nivolumab biweekly for cycle 5 and subsequent of 28 day cycle duration. Subsequent 28 day cycles will last up to 2 years."
15825635|NCT04239040|Drug|Ipilimumab|Intravenous infusion of ipilimumab every 3 weeks, for cycles 1-4. Cycles 1-4 are 21 days
15825636|NCT04239027|Drug|RTH258/Brolucizumab|Brolucizumab is a new generation of anti-VEGF (vascular endothelial growth factor). All patients will be treated with brolucizumab 6mg: 3 loading injections (at Screening/Baseline, Week 4 and Week 8), followed by maintenance treatment from Week 16/Week 20 up to Week 40/Week 44.
15825637|NCT04239014|Drug|Olaparib|Olaparib 300 mg BD (2 × 150 mg tablets) continually in the olaparib monotherapy and ceralasertib+olaparib treatment arms.
15825638|NCT04239014|Drug|Ceralasertib|Ceralasertib 160 mg QD (2 × 80 mg tablets) from Days 1 to 7 (inclusive) of every 28-day cycle.
15825639|NCT04239014|Drug|Placebo to match olaparib|Per olaparib
15825640|NCT04239001|Drug|PEG-rhG-CSF|24 hours after the completion of intravenous infusion of albumin paclitaxel during the treatment period, patients with pancreatic cancer who met the input / discharge criteria were given secondary prophylactic administration of the tested drug PEG-rhG-CSF.
15825641|NCT04238988|Drug|Pembrolizumab|Humanized antibody used in cancer immunotherapy. It targets the programmed cell death protein 1 (PD-1) receptor of lymphocytes.
15825642|NCT04238988|Drug|Carboplatin|Chemotherapy medication
15825643|NCT04238988|Drug|Taxol|Chemotherapy medication
15825644|NCT04238975|Biological|GC3111 vaccine|0.5mL, Intramuscular
15825645|NCT04238975|Biological|Boostrix® vaccine|0.5mL, Intramuscular
15825646|NCT04238962|Drug|Semaglutide (administered by DV3396 pen-injector)|Increasing doses of semaglutide given subcutaneously (sc, under the skin) in the stomach for 7 weeks
15825647|NCT04238962|Drug|Semaglutide (administered by PDS290 pen-injector)|Increasing doses of semaglutide given sc in the stomach for 7 weeks
15825648|NCT04238949|Other|Community Health Worker added to diabetes team|A Community Health Worker will be added to the diabetes team caring for a child with new onset type 1 diabetes for 1 year. The intervention includes social determinants of health screening and goal setting, with home visits.
15825649|NCT04238936|Diagnostic Test|Serum amyloid A values|Women who are diagnosed with GDM between the ages of 18 and 43 will receive blood in the biochemistry tube. This tube will then be centrifuged. A-SAA and IL-1Ra levels will be checked by ELISA method in serum stored at -80 degrees.
15825650|NCT04238936|Diagnostic Test|Interleukin-1 (IL-1) receptor antagonist values (A-SAA and IL-1Ra)|Women who are diagnosed with GDM between the ages of 18 and 43 will receive blood in the biochemistry tube. This tube will then be centrifuged. A-SAA and IL-1Ra levels will be checked by ELISA method in serum stored at -80 degrees.
15825692|NCT04238611|Device|Microneedle|Lactate microneedle applied on the skin of participant
15825651|NCT04238923|Drug|Topical vancomycin paste (1g vancomycin powder + 4mL sterile saline) and Collatamp G gentamicin-eluting sponge (Azralez Pharmaceuticals; 2.0mg gentamicin sulphate/cm2 to cover wound)|Topical vancomycin paste and gentamicin-eluting collagen sponge will be applied directly to the deep layers of the wound following reconstruction, prior to closure.
15825652|NCT04238910|Behavioral|Maximizing Energy|The intent of the MAX intervention is to personalize OT delivered education to facilitate the implementation of Energy Conservation strategies using the PST framework to address specific fatigue-related problems and then to generalize from these solutions to both similar and new situations in daily life.
15825653|NCT04238910|Behavioral|Health Education|The intent of the health education intervention is to control for the non-specific effects of interactions with an interventionist. Participants received education on a variety of health related topics relevant to individuals with TBI.
15825654|NCT04238897|Device|soft contact lens|
15825655|NCT04238884|Drug|Voriconazole preemptive genotyping strategy|The patients who finally receives voriconazole will be randomized to receive the dose according to a pharmacogenetic algorithm including CYP2C19 genotype and clinical and demographic information.
15825656|NCT04238884|Drug|Voriconazole clinical practice|The patients who finally receives voriconazole will be randomized to receive the dose according to clinical practice
15825657|NCT04238858|Biological|Platelet rich plasma|blood is drawn from the patient's antecubital vein and inserted into four 3.0 ml vacutainer tubes that contain trisodium citrate. These four tubes were placed in a centrifuge machine, and centrifugation was carried out at 2500 rpm (580×g) for 8 min within a 30-min blood collection period. As a result of centrifugation, the plasma was separated in the vacutainer tubes from the remaining blood components. Three different layers formed in the tubes: red blood cells at the bottom, aPRP in the middle layer, and aPPP in the top layer. A total of 1.5 ml of the middle layer (which mainly contained platelets) was withdrawn by syringe, and it was immediately injected into the subtenon space of each eye.
15825658|NCT04238845|Drug|AQSP Administration|Three days treatment of all children with AQSP for SMC
15825659|NCT04238845|Dietary Supplement|Supplementation with Plumpy'Doz|Daily supplementation of children with Plumpy'Doz
15825660|NCT04238845|Dietary Supplement|Supplementation with Vitamin A|Single dose supplementation with Vitamin A to all children
15825661|NCT04238845|Dietary Supplement|Supplementation with Zinc|Daily supplementation with Zinc
15825662|NCT04238832|Other|Salt Base Nicotine|Participants will try both free base and salt base nicotine e-liquid and then take home salt base nicotine
15825663|NCT04238832|Other|Free Base Nicotine|Participants will try both free base and salt base nicotine e-liquid and then take home free base nicotine
15825664|NCT04238819|Drug|Abemaciclib|Administered orally
15825665|NCT04238819|Drug|Irinotecan|Administered IV
15825666|NCT04238819|Drug|Temozolomide|Administered orally
15825667|NCT04238806|Drug|Desflurane Inhalational agent|Desflurane inhalational agent administration during the whole cardiac surgical operation with cardiopulmonary bypass versus administration of desflurane inhalational agent before and after cardiopulmonary bypass during the whole period of cardiac surgical operation.
15825668|NCT04238793|Drug|KLS-2031|KLS-2031 administered by transforaminal epidural injection
15825669|NCT04238793|Other|Placebo|Saline solution administered by transforaminal epidural injection
15825670|NCT04238780|Procedure|Erector Spinae Plane Block|The transducer was placed vertically 3cm lateral to the midline to visualize the muscles of the back, transverse process and the pleura in between the two transverse processes. After local infiltration of the needle insertion site with 2-3 ml of 2% lidocaine needle was inserted in cranial-caudal direction towards the transvers process using in plane technique until the needle cross all the muscles then interfascial injection of 20ml local anesthetics is done after ensuring negative aspiration, the procedure was repeated following the same steps on the other side of the back.
15825671|NCT04238767|Drug|Dolutegravir|Eligibility to receive DTG-based ART at enrolment (i.e., initiation or offer to initiate DTG-based ART)
15825672|NCT04238754|Drug|Epidiolex 100 mg/mL Oral Solution|8 mL of Epidiolex (800 mg of cannabidiol) + 16 mL of inactive cherry syrup delivered every 12 hours for 48 hours total (4 doses)
15825673|NCT04238754|Other|Cherry Syrup Oral Solution|20 mL of inactive cherry syrup delivered every 12 hours for 48 hours total (4 doses)
15825674|NCT04238741|Other|Audio-recording of consent for anaesthesia for elective caesarean section|Antenatal women will be invited to attend 5-15 days before their caesarean section for an anaesthetic consent discussion with audio-recording. Participants will complete a questionnaire immediately following the recorded discussion and again within the 48 hours following their surgery, to establish their views on the process of audio-recording of consent and the potential usefulness/acceptability of the audio-recording.
15825675|NCT04238728|Device|Silverlon|silver nylon dressing will be applied daily
15825676|NCT04238715|Drug|E7090|E7090 tablets orally.
15825677|NCT04238702|Drug|Empagliflozin 10 MG|Empagliflozin 10 MG 7 days intervention period
15825678|NCT04238702|Drug|Losartan 50Mg Tab|Losartan 50 MG 7 days intervention period
15825679|NCT04238702|Other|Placebo|Placebo 7 days intervention period
15825680|NCT04238689|Biological|TB31F|Monoclonal antibody
15825681|NCT04238676|Drug|PP353|active administered by intradiscal injection
15825682|NCT04238676|Drug|PP353-B|placebo administered by intradiscal injection
15825683|NCT04238663|Drug|MB02 (Bevacizumab Biosimilar)|Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion
15825684|NCT04238663|Drug|EU approved Avastin®|Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion
15825685|NCT04238663|Drug|US licenced Avastin®|Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion
15825686|NCT04238650|Drug|MB02 (Bevacizumab Biosimilar)|Solution for intravenous infusion, single dose of 3mg/kg, administered as 90- minute infusion
15825687|NCT04238650|Drug|EU approved Avastin®|Solution for intravenous infusion, single dose of 3mg/kg, administered as 90- minute infusion
15825688|NCT04238637|Drug|Durvalumab|Durvalumab IV (intravenous Infusion)
15825689|NCT04238637|Drug|Tremelimumab|Tremelimumab IV (intravenous Infusion)
15825690|NCT04238624|Drug|Dabrafenib|Participants will receive dabrafenib 150 mg orally twice a day
15825691|NCT04238624|Drug|Trametinib|Participants will receive trametinib 2 mg orally once a day
15825693|NCT04238611|Diagnostic Test|Blood lactate measurement|Serum lactate testing through conventional laboratory methods
15825694|NCT04238611|Other|Exercise regimen|Standardised aerobic exercise regimen
15825695|NCT04238598|Procedure|Pulse Radiofrequency|Two 20-gauge radiofrequency needle with 10mm active tip will be placed intra-articularly from an anterolateral and anteromedial approach to target the medial and lateral compartments. Once satisfactory fluoroscopic placement is noted, the Pulsed Radiofrequency treatment will be administered.
15825696|NCT04238598|Procedure|Standard of Care Intra- Articular Injection|Two 20-gauge radiofrequency needle with 10mm active tip will be placed intra-articularly from an anterolateral and anteromedial approach to target the medial and lateral compartments. Once satisfactory fluoroscopic placement is noted, the Intra-Articular treatment will be administered.
15825697|NCT04238598|Procedure|Placebo Intra-Articular Injection|Two 20-gauge radiofrequency needle with 10mm active tip will be placed intra-articularly from an anterolateral and anteromedial approach to target the medial and lateral compartments. Once satisfactory fluoroscopic placement is noted, the Placebo Intra-Articular treatment will be administered.
15825698|NCT04238585|Behavioral|Mobile messaging|Mobile health messages
15825699|NCT04238572|Device|Audiovisual distraction device|Evaluate the impact of an audiovisual distraction device on the peroperative opioid consumption
15825700|NCT04238572|Device|Analgesia nociception index|ANI (Analgesia Nociception Index) will be used for peroperative overall comfort measurement
15825701|NCT04238559|Other|Self-report questionnaire|Fill in the SWAMECO questionnaire
15825702|NCT04238546|Device|sirolimus-coated balloon catheter|angioplasty with sirolimus-coated balloon catheter
15825703|NCT04238546|Device|uncoated balloon catheter|angioplasty with uncoated balloon catheter
15825704|NCT04238533|Other|eADAPT training|eADAPT training for myoelectric prosthesis users is the comparator training.
15825705|NCT04238533|Other|Conventional training|Conventional training with Myoboy has been the only training available to users.
15825708|NCT04238507|Device|Guedel airway|Following induction of GA, air:O2 flows will be set at 0:10L, the Adjustable Pressure Limiting (APL) valve set to 50cm water pressure, and the reservoir bag filled. The learner will perform BMV with a Guedel airway placed by the anesthesiologist, while the anesthesiologist ensures that the reservoir bag is filled between breath attempts by using the oxygen flush.
15825709|NCT04238507|Device|USASK airway|Following induction of GA, air:O2 flows will be set at 0:10L, the Adjustable Pressure Limiting (APL) valve set to 50cm water pressure, and the reservoir bag filled. The learner will perform BMV with a USASK airway placed by the anesthesiologist, while the anesthesiologist ensures that the reservoir bag is filled between breath attempts by using the oxygen flush.
15825712|NCT04238468|Procedure|Intradermal stromal vascular fraction injection|After flank liposuction, lipoaspirate will be processed by enzymatic digestion, thus stromal vascular fraction will be isolated. Just after the wound is closed the stromal vascular fraction diluted in normal saline (5ml) will be injected intradermally on one site.
15825713|NCT04238455|Procedure|Sham serratus anterior plane block|The serratus anterior plane block will be performed by the anesthesiology team just prior to emergence from general anesthesia.
15825714|NCT04238455|Procedure|Serratus anterior plane block|The serratus anterior plane block will be performed by the anesthesiology team just prior to emergence from general anesthesia.
15825715|NCT04238442|Device|A&D TM-2657W oscillometric device|Assessing the accuracy of the A&D TM-2657W oscillometric device using International Standards Organization validation protocol. This involves comparing the accuracy of the A&D device to 2 observer mercury auscultation (gold standard).
15825716|NCT04238429|Drug|Toothpaste containing 10% high cleaning silica base, 0.5% sodium phytate and 0.5% sodium pyrophosphate|Use the toothpaste to brush teeth twice a day for 8 weeks
15825717|NCT04238429|Drug|Control toothpaste|Use the toothpaste to brush teeth twice a day for 8 weeks
15825718|NCT04238416|Drug|Branched chain amino acid|Intravenous branched chain amino acids will be given for 3 days to patients in experimental arm
15825719|NCT04238416|Drug|Lactulose|Oral lactulose will be given to patients in both arms
15825720|NCT04238403|Behavioral|Behavioral Parent Training (MATCH Protocol)|BPT. Behavioral Parent Training (BPT) is a well-established psychosocial intervention for the treatment for ADHD and related behavioral difficulties (e.g., oppositional problems). BPT is based on social learning and operant conditioning principles in which parents are instructed to utilize methods (e.g., praise, effective communication, reward systems, time-out from positive reinforcement) to facilitate positive behaviors in their child (e.g., compliance) and reduce challenging behaviors (e.g., opposition). BPT comes in several manualized, commercially available manuals. The version of BPT that we will be utilizing is from the MATCH protocol (Chorpita and Weisz, 2009), which consists of 10 components, delivered with individual families, typically over the course of 10-16 weekly individual meetings (total meetings depends upon parent availability and acquisition of BPT skills).
15825721|NCT04238390|Drug|Ceftolozane-Tazobactam|Ceftolozane-tazobactam 3 grams (comprising ceftolozane 2 grams and tazobactam 1 gram) administered, every 8 hours, three times a day, intravenously over 60 mins. Dose adjusted for renal function.
15825722|NCT04238390|Drug|Meropenem|Meropenem 1 gram, every 8 hours, three times a day, intravenously over 30 mins. Dose adjusted for renal function.
15825773|NCT04238065|Device|Patch|2 hours patch to the non-amblyopia eye if the other amblyopia eye is mild or moderate amblyopia; 6 hours patch to the non-amblyopia eye if the other amblyopia eye is severe abmlyopia
15825723|NCT04238377|Procedure|Stellate Ganglion Block|"Using US with a linear array transduce, subfascial-C6- Stellate Ganglion Block. Patients will be supine with the neck slightly hyper- extended. After aseptic preparation of the skin, the transducer is placed on the neck to enable cross sectional visualization of anatomical structures at the level of C6. The carotid artery, internal jugular vein, thyroid gland, trachea, longus colli covered with the prevertebral fascia, root of C6, and transverse process of C6 are all visualized. The transducer will then gently be pressed between the carotid artery and trachea to retract the carotid artery laterally and to position the transducer close to the longus colli.
~A 1.0-inch, 25-gauge long-bevel needle were paratracheal inserted toward the middle of the longus colli. The endpoint for injection were the ultrasound image demonstrating the tip of needle penetrating the prevertebral fascia in the longus colli. After negative aspiration, 5 mL of 0.5% bupivacaine was injected"
15825724|NCT04238377|Drug|Multimodal Analgesia|Multimodal analgesia in the form of administering of IV paracetamol 1000 mg one hour prior to start of surgery in combination 30 mg ketorolac and Single preoperative 0.1 mg/kg dose dexamethasone has a combined action, anti-emetic and provides enhanced analgesia, with intra-operative fast acting opioid analgesics, Fentanyl 2 mic/kg
15825725|NCT04238364|Drug|EI1071|EI1071 Tablet(s)
15825726|NCT04238364|Drug|Matching Placebo|Matching Placebo Tablet(s)
15825727|NCT04238351|Device|Transnasal humidified rapid insufflation ventilator exchange|applying 40L of oxygen for 1min and afte that increase oxygen flow up to 70L for 1 min.
15825728|NCT04238351|Device|Conventional face mask|applying oxygen using usual face mask
15825729|NCT04238338|Other|monocyte / lymphocyte ratio|The lymphocyte / monocyte ratio should be tested every 3 months after the start of the study, and the final value is the average
15825730|NCT04238312|Device|RESPeRATE™|Fifty-five anxious pediatric dental patients received a breathing session of 10 minutes, using the RESPeRATE™ device.
15825731|NCT04238312|Behavioral|Tell, Show and Do technique|Fifty-five anxious pediatric dental patients received a traditional behavior management technique (Tell-Show-Do).
15825732|NCT04238299|Diagnostic Test|Multiparametric renal MRI|Localiser scans; Kidney volume; Longitudinal (T1) relaxation time mapping; Diffusion weighted imaging (DWI); Phase Contrast MRI; Arterial spin labelling (ASL); Blood Oxygen Level Dependent (BOLD) mapping
15825733|NCT04238286|Procedure|Dry needling|All the participants will be placed in a prone position on the bench. Once the subject is settled, we will localize a nodule within the palpable taut band, confirming its presence after inducing local twitch response by palpation. After placing the MTrPs, the area will be sterilized with an alcohol solution colorless spray [Skin-des. Agupunt ®]. The puncture method used in the true dry needling groups will be the Hong's fast in-fast out technique, described as the most aggressive technique in the MTrPs treatment, using a needle of 0.32 x 40 mm. The intervention will be implemented until the subject reports the presence of seven local twitch reactions to the controller.
15825734|NCT04238273|Diagnostic Test|Functional Echocardiography|Imaging studies to assess Hemodynamics of both groups on and off non invasive ventilation
15825735|NCT04238260|Behavioral|Enhancing Physical Therapy Usual Care|The protocol is focused on the completion of a minimum of 30 minutes of weight-bearing, walking-related activities that progressively increase in intensity informed by heart rate and step counters over 4 weeks.
15825736|NCT04238260|Behavioral|Physical Therapy Usual Care|Usual physical therapy
15825738|NCT04238234|Device|IVC Ultrasonography|Ultrasound measurements will be performed using a curved transducer set to abdominal mode (1-5 MHz; Acuson x300; Siemens Healthcare, Seoul, Korea). IVC variation will be assessed using ultrasound in the long-axis (sagittal) view. IVC diameter will be measured 1 cm distal to its junction with hepatic vein either by 2-D or M modes via a subcostal approach according to the methodology described by the American Society of Echocardiography . A two-dimensional image of the IVC as it enters the right atrium will be first obtained.
15825739|NCT04238234|Device|Plethysmographic variability index (PVI) and perfusion index readings (PI)|"The PVI and PI will be recorded in the supine position by an anaesthesiologist who was not involved in the further intraoperative monitoring of the patient using Masimo SET (MightySat 9900, Masimo Corporation, Irvine, CA, USA).
~PVI (%) is a measure of the dynamic change in PI that occurs during one or more complete respiratory cycles, calculated as:
~PVI= [(PImax-PImin)/PImax] x100"
15825740|NCT04238221|Drug|Doxofylline|Patients will receive a 4-week treatment with doxofylline 400 mg bid, in addition to their chronic usual inhalation therapy.
15825741|NCT04238208|Drug|Lidocaine 5% patch|5% lidocaine patch (Lidoderm®, Endo Pharmaceuticals Inc, Malvern, USA) 10 x 14 cm
15825742|NCT04238208|Drug|Capsaicin 8% Patch, Per 10 Square Centimeters|8% Capsaicin patch [8% w/w] 640 µg/cm² of adhesive, patch area 280 cm2 (20 cm x 14 cm), (Qutenza®; capsaicin 179 mg patch, Astella Pharma Europe Ltd. Chertsey, UK)
15825743|NCT04238195|Drug|Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr) + Placebo|Treatment A: Subjects receive TBPM-PI-HBr + matching Placebo.
15825744|NCT04238195|Drug|Moxifloxacin 400mg|Treatment D: Subjects receive 1 400 mg tablet of moxifloxacin administered in an open label manner.
15825745|NCT04238195|Other|Placebo for Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr)|Treatment C: Subjects receive TBPM-PI-HBr matching placebo.
15825746|NCT04238195|Drug|Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr)|Treatment B: Subjects receive TBPM-PI-HBr.
15825747|NCT04238182|Other|wet cupping|This smoker group will receive single wet cupping session. The first site is between the two scapulae (interscapular), opposite the T1-T3 scapular spine. This area is called Al-Kahil in Arabic. The second site is located on the spinous process of seventh cervical vertebra and it is called GV14 in Chinese medicine. The third site is BL-17 (Ge Shu Diaphragm Shu) is located 1.5 cun lateral to the lower border of the spinous process of the seventh thoracic vertebra (T7). BL 17 can directly act on the septum transversum of diaphragm . Cupping of BL 17 will be done bilaterally.
15825771|NCT04238065|Device|Caterna Virtual Reality|"Vivid interactive games of perceptual learning content, with artificial intelligent sound and scores to feedback vision and actions results, which can be connected to the supervision of cellphone softwareWechat to upload vision acuity and choose 2 eyes' video output automaticly."
15825748|NCT04238182|Other|dry cupping|The smoker group will receive single dry cupping session. The first site is between the two scapulae (interscapular), opposite the T1-T3 scapular spine. This area is called Al-Kahil in Arabic. The second site is located on the spinous process of seventh cervical vertebra and it is called GV14 in Chinese medicine. The third site is BL-17 (Ge Shu Diaphragm Shu) is located 1.5 cun lateral to the lower border of the spinous process of the seventh thoracic vertebra (T7). BL 17 can directly act on the septum transversum of diaphragm. Cupping of BL 17 will be done bilaterally.
15825749|NCT04238169|Drug|Bevacizumab|7.5mg/kg once every three weeks
15825750|NCT04238169|Drug|Toripalimab|240 mg once every three weeks
15825751|NCT04238169|Radiation|SBRT|30-50Gy/5F（2-4 lesions）
15825752|NCT04238156|Other|Hypopressive abdominal exercises|Three sessions per week during four consecutive weeks (Total: 12 sessions). Each session time: 30 minutes.
15825753|NCT04238143|Procedure|Tissue Stromal Vascular Fraction (tSVF) Arm 1|Harvesting subcutaneous tSVF with sterile, disposable microcannula system
15825754|NCT04238143|Biological|PRP Concentrate Arm 1|Preparation of PRP Concentrate via sterile Terumo-Harvest System
15825755|NCT04238143|Procedure|Tissue Stromal Vascular Fraction (tSVF) Arm 2|Harvesting subcutaneous tSVF with sterile, disposable microcannula system
15825756|NCT04238143|Biological|PRP Concentrate Arm 2|Preparation of PRP Concentrate via sterile Terumo-Harvest System
15825757|NCT04238143|Procedure|Cellular Stromal Vascular Fraction (cSVF) Arm 2|Isolation-Concentration of cSVF via sterile enzymatic digestion (Liberase TM, Sterile Roche)
15825758|NCT04238143|Procedure|Cellular Stromal Vascular Fraction (cSVF) Arm 3|Isolation-Concentration of cSVF via sterile enzymatic digestion (Liberase TM, Sterile Roche)
15825759|NCT04238143|Drug|Sterile Normal Saline (IV Solution)|Suspension of cSVF in 500 cc Sterile Normal Saline (IV Solution)
15825760|NCT04238130|Diagnostic Test|Perioperative ctDNA Dynamic Monitoring|To apply ctDNA dynamic monitoring in early stage NSCLC patients with driver mutations positive at baseline
15825761|NCT04238117|Procedure|Laser acupuncture treatment|Laser acupuncture therapy (LAT) is a noninvasive technique that involves stimulation of traditional acupoints with low intensity, non thermal laser irradiation.
15825762|NCT04238104|Other|no intervention|it's only observational study. No interventions.
15825770|NCT04238078|Drug|Contraceptive|Oral contraceptive pill
15825772|NCT04238065|Device|Spectacles(Best optical corrected distance vision)|Each eye has best corrected vision spectacles with best corrected optical lens.
15826144|NCT04234867|Other|Stress|single dose after last administration of experimental drug
15825774|NCT04238026|Procedure|Distal radial artery approach|Use of distal radial artery approach in coronary angiography and angioplasty
15825775|NCT04238013|Other|Whole Body Vibration (WBV)|The WBV session will consist of 8 bouts of 45s vibration (50Hz) with a minute of rest in between each bout.
15825776|NCT04238013|Other|Electrical Stimulation|The electrical stimulation intervention serves to account for any effects of standing and/or of repeated performance of the sit-to-stand behavior on neurophysiological outcomes. In the electrical stimulation intervention, participants will receive electrical stimulation while standing on the vibration platform for 8 bouts for 45s with a minute of rest in between without vibration.
15825777|NCT04238000|Device|repetitive transcranial magnetic stimulation|Cerebellar repetitive theta Burst stimulation will be performed as detailed in the Real arm description
15825778|NCT04237987|Drug|Interleukin-2|Interleukin-2 was produced by Beijing Shuanglu Pharmaceutical Co., Ltd
15825779|NCT04237987|Drug|ciclosporin and corticosteroid|ciclosporin and corticosteroid
15825780|NCT04237974|Device|computed tomography pulmonary angiography|The radiological severity of pulmonary embolism will be assessed by using the computed tomography pulmonary arterial obstruction index (CT-PAOI)
15825781|NCT04237961|Procedure|Botox and brow lift|Botox injection
15825782|NCT04237961|Procedure|Injection|Fat injection and botox
15825783|NCT04237961|Procedure|Suture|Suspension suture
15825784|NCT04237948|Device|transcranial direct current stimulation (tDCS)|cerebellar tDCS consists in the application of a low intensity (1-2 mA) steady current through a surface scalp electrode over the cerebellum
15825785|NCT04237948|Behavioral|Physical therapy|Hospitalized patients will undergo a 60 minutes physical treatment improving gait and postural instability for four weeks of time
15825786|NCT04237935|Drug|Ticagrelor 90mg|Ticagrelor 90 mg dispensing claim is used as the exposure group
15825787|NCT04237935|Drug|Clopidogrel 75mg|Clopidogrel 75 mg dispensing claim is used as the reference group
15825788|NCT04237922|Drug|Prasugrel 10mg|Prasugrel 10mg dispensing claim is used as the exposure group
15825789|NCT04237922|Drug|Clopidogrel 75mg|Clopidogrel 75 mg dispensing claim is used as the reference group
15825790|NCT04237909|Biological|PRP injection into at least one ovary|The same day, within 2 hours of sample preparation, PRP injection will be performed transvaginally under ultrasound guidance and under sedation anesthesia into at least one ovary using a 35 cm 17 G single lumen needle. The injection will be done underneath the ovarian cortex to the subcortical and stromal areas. Approximately 2-4cc of the PRP solution will be injected into each ovary. After the procedure, the patients will be taken to the recovery room and will be observed for 30-40 minutes and also be discharged home on the same day.
15825791|NCT04237883|Behavioral|Standard communication email|This is the base communication that all physicians will receive.
15825792|NCT04237883|Behavioral|Social comparison Intervention|The social comparison is added onto the standard communication email to provide some peer comparison between the physicians.
15825793|NCT04237883|Behavioral|Leadership Training|Clinic and Physician leads will be provided with a clinic leadership training seminars in leadership, quality improvement, and support from the Quality Improvement team at UCLA Health.
15825794|NCT04237870|Device|Active cTBS|Active cTBS treatment will be delivered at an intensity that is 70% of the resting motor threshold (RMT). cTBS consist of bursts of 3 magnetic pulses at 30 Hz repeating every 200 ms for 300 pulses. cTBS will be repeated twice with 15 min interval. The cTBS sessions last for 4 weeks, 5 times a week. Treatment will be applied to central suleus.
15825795|NCT04237870|Device|Sham|Sham stimulation will be delivered using the same stimulation parameters and at the site of active treatment, but with only the side-edge resting on the scalp. The coil will be angled 45 degrees way from the skull in a single-wing tilt position. This method produces sound and some somatic sensation (e.g. contraction of scalp muscles) similar to those of active stimulation, but with minimal direct brain effects.
15825796|NCT04237857|Procedure|Laparoscopic sleeve gastrectomy|Laparoscopic sleeve gastrectomy
15825797|NCT04237831|Drug|BMS-986259|Specified Dose on Specified Days
15825798|NCT04237818|Dietary Supplement|Placebo drink|consume 2 bottle (30 mL) per day for 56 days
15825799|NCT04237818|Dietary Supplement|Chenopodium Formosanum and Fagopyrum Esculentum Extract drink|consume 2 bottle (30 mL) per day for 56 days
15825800|NCT04237805|Drug|SAF-189s|20mg，40mg，80mg，120mg，160mg，210mg，once daily
15825801|NCT04237792|Drug|dexmedetomidine|dexmedetomidine low, middle and high doses are provided as an intravenous bolus loading dose followed by an intravenous maintenance dose infusion throughout the MRI scan
15825802|NCT04237792|Drug|propofol|propofol IV administration will be given if needed to maintain sedation
15825803|NCT04237779|Biological|PRP injection into at least one testis|Autologous blood obtained from peripheral vein will be used to prepare PRP following standard protocols. PRP injection will be performed under local anesthesia. Sperm analysis, testicular volumes (using orchiometer), serum FSH and testosterone measurements will be re-evaluated at 8 weeks post-procedure. On the third month after the procedure, presence of spermatozoa will be reassessed in micro testicular sperm extraction (TESE) material.
15825804|NCT04237766|Other|Experimental group|"The intervention will consist of the visualization of the movement through the Mirror Therapy application, or through the reproduction of an immersive 360º video emitted on a mobile device and visualized with virtual reality glasses.
~The movements observed with both technologies will be the same. The knee extension and dorsal ankle flexion movements (quadriceps and triceps sural), together with the elbow flexion (elbow flexors) will be the movements to be performed, based on their functional need (ambulation and feeding, respectively)."
15825805|NCT04237753|Behavioral|VA Video Connect|Remote telehealth visits with continence care provider who will provide education on bladder anatomy and function, pelvic floor muscle exercises with behavioral strategies, and self-monitoring tools for urine leakage
15825806|NCT04237753|Behavioral|MyHealtheBladder|Daily mobile health education with information on bladder anatomy and function, pelvic floor muscle exercises with behavioral strategies, and self-monitoring tools for urine leakage
15825807|NCT04237740|Drug|relenvatinib|The enrolled patients are treated with lenvatinib (dose: body weight < 60 kg: 8 mg/day, body weight ≥ 60 kg 12 mg/day).
15825808|NCT04237727|Device|Fluxmed GrH will be used to measure the ventilation parameters|The study will be a prospective descriptive multicenter study where measurement of ventilation data will be sampled during CPR by EMS treating patients with OHCA.
15825809|NCT04237714|Behavioral|Smiling is fun|"Smile is Fun is a self-applied program that combines elements of prevention and psychological treatment for emotional disorders. It is delivered via the Internet and it is based on CBT technics. The program consists of 8 therapeutic modules and includes 3 transversal tools (activity report, calendar, how am I?) to provide feedback and accompany patients during the intervention. The program requires 8 to 10 weeks to complete in its entirety.
~The intervention, initially developed in Spain, will be adapted to the Ecuadorian culture including elements of the local population, such as, dialect, personal stories, examples and activities. The Ecuadorian version will be evaluate by health professional and users of public health system of Ecuador."
15825810|NCT04237675|Procedure|surgery and anesthesia|patients with MS who received general or regional anesthesia for a surgery or labor
15825811|NCT04237662|Procedure|Root Instrumentation|Instrumentation of the root surface in order to achieve debridement
15825812|NCT04237662|Device|Enamel Matrix Derivative application|Enamel Matrix Derivative will be applied in the sites with at least 6 mm of pocket depths
15825813|NCT04237649|Drug|KAZ954|KAZ954 will be administered in every arm.
15825814|NCT04237649|Drug|PDR001|KAZ954 + PDR001
15825815|NCT04237649|Drug|NIR178|KAZ954 + NIR178
15825816|NCT04237649|Drug|NZV930|KAZ954 + NZV930
15825817|NCT04237623|Drug|Sargramostim|250mcg/m2/day IV starting Day +5
15825818|NCT04237623|Other|Control Arm|Standard G-CSF given to those who decline to receive GM-CSF
15825819|NCT04237610|Behavioral|behavioral assessment|Probabilistic learning task
15825820|NCT04237597|Drug|K-877|K-877 tablets
15825821|NCT04237597|Drug|CSG452|CSG452 tablets
15825822|NCT04237584|Drug|Darolutamide|Participants will be randomly assigned to 12 weeks lead-in ARB (darolutamide or enzalutamide) that will continue after double-blind randomization to radium-223 or placebo.
15825823|NCT04237584|Drug|Enzalutamide|Participants will be randomly assigned to 12 weeks lead-in ARB (darolutamide or enzalutamide) that will continue after double-blind randomization to radium-223 or placebo.
15825824|NCT04237584|Drug|Radium-223|After a 12-week lead-in period of open-label ARB, participants will be randomized to double-blind radium-223 or placebo. Participants will continue on their randomized, open-label ARB.
15825825|NCT04237584|Other|Placebo|After a 12-week lead-in period of open-label ARB, participants will be randomized to double-blind radium-223 or placebo. Participants will continue on their randomized, open-label ARB.
15825826|NCT04237571|Behavioral|CANE Meal Program|Participants will be encouraged to pick up a healthy meal from the Community Agriculture Nutritional Experience (CANE) Kitchen in Whitesburg, Kentucky once a week for five weeks. The meals will consist of at least one serving of a fruit or a vegetable. At each meal, education materials will be distributed, including the recipe for the healthy meals and nutrition handouts that are linked to the recipes. Additional information about the ways the nutrients in the meal may help protect from the negative effects of environmental pollutants will be included.
15825827|NCT04237558|Procedure|Vaginal hysterectomy|Vaginal hysterectomy by removal of uterus through vagina in absence of prolapse
15825828|NCT04237558|Procedure|Laparoscopic hysterectomy|Laparoscopic hysterectomy through key hole surgery through small incisions of the abdomen
15825829|NCT04237545|Device|T3 short and restoration (prosthesis)|A qualified patient will be treated with a T3 short implant according to randomization assignment during implant placement surgery visit. The implant will then be restored with a prosthesis and followed up for yearly visits for a total of 4 years.
15825830|NCT04237545|Device|T3 standard length and restoration (prosthesis)|A qualified patient will be treated with a T3 standard length implant according to randomization assignment during implant placement surgery visit. The implant will then be restored with a prosthesis and followed up for yearly visits for a total of 4 years.
15825831|NCT04237532|Drug|Intranasal Dexmedetomidine|The mucosal atomizing device will be used intranasally where the sedative drug will be equally divided and sprayed into each nostril while the child semi reclined position.
15825832|NCT04237532|Drug|Sublingual Dexmedetomidine|The mucosal atomizing device will be used sublingually by asking the child to touch their maxillary incisor teeth with the tip of their tongue and instruct the child not to swallow the drug for 30 seconds.
15825833|NCT04237519|Behavioral|SFL training|"The SFL training program comprises:
~Physical exercises: 50 video exercises to improve balance, muscle strength and physical capabilities in older adults;
~Cognitive exercises: Four ludic activities targeting problem solving (4 Images/ 1 word), memory (Quiz and Recall me), speed processing and divided attention (Attention!).
~In addition, the SFL program includes a series of unique components:
~Chat rooms: to share views about topics of interest and tips for common real-life problems;
~Psycho-education content: to improve self-management and promoting cognitive transfer though 22 different topics (provide recommendations usually given in psychotherapy sessions);
~Virtual coach: to guide participants along the proposed exercises by giving them instructions, reminding them regularly to practice a variety of available activities repeatedly, providing appropriate and timely feedback on participant's performances and rewarding assiduity, perseverance and performance."
15825834|NCT04237519|Behavioral|Active controlled training|"The active control training program is structured in the same manner as the SFL training program and will also offer different physical and cognitive activities:
~Physical exercises: 12 different exercises trains upper and lower extremity strength, mobility and balance offered through a computerized version of a health insurance company physical training program;
~Cognitive activities: Four commercially available leisure activities (Sudoku. Cross Words, Pac-Man and Countdown activities) that are appreciated by older adults but do not teach cognitive strategies and are were not designed to improve cognition per se.
~No chat room, psycho-educational content or virtual coach were included in the active control training program."
15825835|NCT04237506|Behavioral|Targeted ballet dance|The one-hour ballet dance class will be provided twice per week for six weeks. The syllabi are adapted from the Joffrey Ballet Academy and Royal Academy of Dancing that are targeting grades primary to level 1 and typically developing kids at the age of 6 to 10 years old. PI will be the class instructor, and the class structure will follow the guidelines in 'Dance program for physical rehabilitation and participation in children with cerebral palsy' by Lopez-Ortiz et al.
15825836|NCT04237493|Drug|Metformin and Glimepiride (Low Dosage)|"Metformin (PO; 850 mg; BID [with Ifṭār and with Suḥūr])
~Glimepiride (PO; 1.5 or 3 mg [75% of the pre-Ramadan dose]; OD [with Ifṭār])"
15826145|NCT04234867|Other|Placebo Stress|single dose after last administration of experimental drug
15825837|NCT04237493|Drug|Metformin and Vildagliptin (Low Dosage)|"Metformin (PO; 850 mg; BID [with Ifṭār and with Suḥūr])
~Vildagliptin (PO; 50 mg; OD [with Ifṭār])"
15825838|NCT04237493|Drug|Metformin and Insulin Glargine U100 (Low Dosage)|"Metformin (PO; 850 mg; BID [with Ifṭār and with Suḥūr])
~Insulin Glargine U100 (SC; 9-33 units [75% of the pre-Ramadan dose]; OD [at 10 P.M.])"
15825839|NCT04237493|Drug|Metformin, Insulin Glargine U100, and Human Regular Insulin (Low Dosage)|"Metformin (PO; 850 mg; BID [with Ifṭār and with Suḥūr])
~Insulin Glargine U100 (SC; 6-39 units (75% of the pre-Ramadan dose); OD [at 10 P.M.])
~Human Regular Insulin (SC; 15-33 units before Ifṭār and 6-18 units before Suḥūr [75% of the pre-Ramadan doses])"
15825840|NCT04237493|Drug|Metformin and Glimepiride (Regular Dosage)|"Metformin (PO; 850 mg; BID [with Ifṭār and with Suḥūr])
~Glimepiride (PO; 2 or 4 mg [100% of the pre-Ramadan dose]; OD [with Ifṭār])"
15825841|NCT04237493|Drug|Metformin and Vildagliptin (Regular Dosage)|"Metformin (PO; 850 mg; BID [with Ifṭār and with Suḥūr])
~Vildagliptin (PO; 50 mg; BID [with Ifṭār and with Suḥūr]])"
15825842|NCT04237493|Drug|Metformin and Insulin Glargine U100 (Regular Dosage)|"Metformin (PO; 850 mg; BID [with Ifṭār and with Suḥūr])
~Insulin Glargine U100 (SC; 11-44 units [100% of the pre-Ramadan dose]; OD [at 10 P.M.])"
15825843|NCT04237493|Drug|Metformin, Insulin Glargine U100, and Human Regular Insulin (Regular Dosage)|"Metformin (PO; 850 mg; BID [with Ifṭār and with Suḥūr])
~Insulin Glargine U100 (SC; 8-52 units (100% of the pre-Ramadan dose); OD [at 10 P.M.])
~Human Regular Insulin (SC; 12-40 units before Ifṭār and 7-28 units before Suḥūr [100% of the pre-Ramadan doses])"
15825844|NCT04237480|Diagnostic Test|serum value 1,25(OH)2 vitamin D|statistical evaluation of the serum values
15825845|NCT04237454|Device|Thermal Imaging Camera|To develop a non-ionising radiation-based method of excluding fractures in children with suspected physical abuse
15825846|NCT04237441|Other|observation|observation before and after multidisplinary team conference was implemented
15825847|NCT04237428|Biological|CD19 CAR-T cells infusion|"Biological: CD19 CAR-T cells infusion Biological: CD19 CAR-T cells infusion. Pretreatment: patients enrolled in this study will receive cyclophosphamide or fludarabine plus cyclophosphamide. CD19 CAR-T cells infusion are allowed within 2 weeks after treatment.
~CD19 CAR-T cells infusion: 30-60 minutes before infusion, H1 anti-histamine agents are applied (acetaminophen 30mg,po.; promethazine 25mg,i.v. ; diphenhydramine 0.5-1mg/kg, no more than 50mg.). Non-physiological doses of corticosteroids are not applied for patients during treatment or recovery unless a life-threatening emergency occurs. CD19 CAR-T cells are infused into patients for one time, the number of infused CD19 CAR-T cells are 0.5-4×10^6/kg."
15825848|NCT04237415|Procedure|EMG biofeedback training|
15825849|NCT04237402|Other|Hair follicles sampling|The hair follicles will be collected by strand of 5 to 6 hairs approximately in the scalp (centro-parietal part), in order to obtain 20 follicles with epithelial sheath.
15825850|NCT04237389|Procedure|Ablation Index Guided endocardial catheter radiofrequency ablation|Ablation Index (AI) guided catheter RF ablation with circumferential ablation around the right and left PVs and 2 additional lines between the lower and upper PVs (endoBox-lesion).
15825851|NCT04237389|Procedure|minimally invasive thoracoscopic surgical epicardial ablation.|"Description: minimally invasive thoracoscopic surgical epicardial ablation using Box-lesion set, which includes isolation of the right and left PVs, roof and posterior wall lines and removal of the LAA."
15825852|NCT04237376|Drug|Tenofovir Alafenamide 25 MG|Tenofovir Alafenamide 25 mg, per oral daily was taken by CHB pregnant mothers with viral load ≥ 2 × 10^6 IU / mL from gestational week 28 to delivery of infant to prevent MTCT.
15825853|NCT04237376|Drug|Tenofovir Disoproxil Fumarate 300 MG Oral Tablet|Tenofovir Disoproxil Fumarate 300 mg, per oral daily was taken by CHB pregnant mothers with viral load ≥ 2 × 10^6 IU / mL from gestational week 28 to delivery of infant to prevent MTCT.
15825854|NCT04237363|Behavioral|Exercise|Underwater treadmill training and supplemental overground walk training
15825855|NCT04237350|Behavioral|Video recording for behaviors|"A domenstic apparatus, scenario, and procedure is applied to record all the behavioral phenotypes.
~For each standardized procedure, the guardian sits in the chair, holding the infant facing the mobile phone screen. Each infant is given a few minutes to adapt to the surroundings and to be calm before recording. No hints or simulations are permitted during the entire process. The recording process lasted for about 3 minutes to ensure that behavioral phenotypes could be completely recorded."
15825856|NCT04237337|Other|Exposure to MS drugs|Exposure in ICSRs to MS drugs (dichotomous, exposed/not exposed), for each individual MS drug
15825857|NCT04237324|Procedure|Treatment one side BLE by NAFL|One side of the patient face underwent treatment using the ResurFX module of M22 (Lumenis Co., Yokneam, Israel) randomly.
15825858|NCT04237324|Procedure|Treatment another side BLE by FMR|One side of the patient face underwent treatment using FMR device (INFINI, Lutronic Co., Goyang-si, Korea).
15825859|NCT04237311|Procedure|Sleeve gastrectomy|Laparoscopic sleeve gastrectomy is performed as following: after greater curvature dissociating, the gastric tube was calibrated over a 36F bougie and transection started approximately 5-6 cm from the pylorus toward the left diaphragmatic crus, using linear cutting stapler of 3.5- or 4.8-mm-high staples, depending on gastric thickness.
15825860|NCT04237311|Procedure|Roux-en-Y gastric bypass|Laparoscopic Roux-en-Y gastric bypass is performed as following: a gastric pouch of approximately 30mL was obtained using linear cutting stapler, the sum of the length of the alimentary limb and the biliopancreatic limb> 200 cm (can be adjusted according to the incidence of the patient's BMI, type 2 diabetes mellitus and the specific situation).
15825861|NCT04237298|Device|Modified vacuum-formed retainer covering the palete|The modified vacuum-formed retainer is made where it would cover the hard palate to the second molars. The only difference in constructing this modified VFR when compared to the normal VFR would be the outline which would be trimmed by the technician.
15825862|NCT04237298|Device|Hawley retainer|Standard retention regime for patients with arch expansion. Patients will be instructed to wear the retainer 24 hours during the study period.
15825892|NCT04237012|Other|Over the counter Artificial tears|over the counter artificial tears PRN at patient discretion
15825947|NCT04236544|Behavioral|DECIMS-Wiki|The active comparator is DECIMS-Wiki, which is an evidence-based online information platform. It is considered to be excellent factual information about immunotherapies for multiple sclerosis.
15825948|NCT04236531|Other|Cognitive tests and neuroimaging|comparison of cognitive performances and brain anatomy
15825863|NCT04237285|Other|Inhalation aromatherapy|Besides routine care, the Control Group was treated with jojoba oil (Simmondsia Chinensis- produced by Arifoğlu, obtained from jojoba fruits by cold squeezing method) inhalation aromatherapy 15 minutes before Hydrotherapy. Jojoba oil was used as a placebo because it had no specific odor. Besides routine care Intervention-15 Group received lavender oil (Lavandula angustifolia Miller Oleum-produced by Arifoğlu, obtained from lavender flowers by water vapor distillation method) inhalation aromatherapy 15 minutes before Hydrotherapy and besides routine care Intervention-60 Group received lavender oil inhalation aromatherapy 60 minutes before Hydrotherapy.
15825864|NCT04237272|Other|Pod System E-cig|Participants assigned to this intervention will try to pod system e-cigarette in the lab and receive a pod system e-cigarette to use for a three week sampling period.
15825865|NCT04237272|Other|Customizable Tank E-cig|Participants assigned to this intervention will try to customizable tank system e-cigarette in the lab and receive a customizable tank system e-cigarette to use for a three week
15825866|NCT04237272|Other|Control|Participants will not receive any e-cigarette
15825867|NCT04237259|Other|Parent-administered TCM pediatric massage training|"Massage therapy is a kind of complementary and alternative therapy, which involves a number of techniques such as friction, pressing, rubbing, grasping, pinching, and kneading. TCM pediatric massage, also called pediatric tuina and pediatric anmo, is a special part of TCM massage system that usually use lines or surfaces rather than points as acupoints and the manipulations are different from those of TCM adult massage. From TCM perspective, the pathogenesis of ADHD is the abnormal exuberance of yang, which can be relieved by specific approaches of massage.
~Participants in this group will receive two TCM pediatric massage training sessions (5 hours in total, one is 3 hours, and the other is 2 hours). The protocol will be tested for feasibility at the first feasibility stage (the first 8 subjects)."
15825868|NCT04237259|Other|Progressive Muscle Relaxation Exercise|The principle of progressive muscle relaxation exercise is to achieve a relaxation state through relaxing our muscles. With training, we become more familiarized with the sense of relaxation so that we can voluntarily induce this sensation in the face of a stressor.
15825869|NCT04237246|Drug|Tacrolimus|"24 hour long acting advegraf"
15825870|NCT04237220|Diagnostic Test|stomach biopsies|To determine the diagnostic performance in the detection of Helicobacter pylori in biopsies taken only from the gastric antrum for the determination of the positive predictive value, the negative predictive value, and sensitivity and specificity.
15825871|NCT04237181|Device|Filmarray PCR multiplex-PCT assay|Filmarray PCR multiplex gastro intestinal panel on stools and serum PCT dosage
15825872|NCT04237168|Diagnostic Test|IgNGS from circulating tumor DNA|3 longitudinal plasma samples will be evaluated at three different time points per patient: 0 (pre-treatment), end of treatment, and at 6 months after treatment.
15825873|NCT04237155|Other|Questionnaire|Subjects will complete a verbal material scoring questionnaire
15825874|NCT04237155|Other|Cognitive tests|Subjects will complete two source-monitoring tasks: the source-monitoring task which will be created from step 1 as well as the task of reference
15825875|NCT04237142|Diagnostic Test|Vaginal secretions collection|Vaginal secretions are collected under speculum with a swab (10 seconds of impregnation of the swab). The swab is immersed in a tube containing an extraction buffer for 10 seconds. The tube is mixed and sent to the laboratory for subsequent analysis of biomarkers (IGFBP1 T/N, PIBF, PP14) and storage.
15825876|NCT04237142|Diagnostic Test|Blood sample|2 tubes of blood sample were collected and sent to the laboratory for serum storage and biomarkeurs assay (PIBF and MIF)
15825877|NCT04237129|Drug|Gan & Lee Insulin Aspart|All three IMPs will be administered as a 0.2 U/kg single dose subcutaneously in the periumbilical area.
15825878|NCT04237116|Biological|Investigational Arm - secukinumab|secukinumab 300mg s.c. weekly in first 4 weeks, followed by q4w up to Week 20; and placebo 300mg s.c. at weeks 13, 14 and 15 to maintain the blind
15825879|NCT04237116|Biological|Control Arm - placebo|placebo 300 mg s.c. weekly in first 4 weeks, followed by q4w up to Week 8; and secukinumab 300 mg s.c. weekly for 4 weeks starting at Week 12, followed by q4w up to Week 20
15825880|NCT04237103|Drug|Methotrexate|oral capsules taken once a week
15825881|NCT04237103|Drug|Placebos|Administered identically to the experimental group
15825882|NCT04237090|Drug|Diphenhydramine|Drug identification number : 02369567
15825883|NCT04237090|Drug|Cetirizine|Drug identification number : 02231603
15825884|NCT04237090|Drug|Lactose pill|Natural product number : 00501190
15825885|NCT04237090|Drug|Sodium chloride 0.9%|Drug identification number : 00037796
15825886|NCT04237077|Other|telephone coaching program|telephone coaching program : 7 phone calls by nurse
15825887|NCT04237077|Other|no telephone coaching program|no telephone coaching program : 7 phone calls by nurse
15825888|NCT04237064|Diagnostic Test|Photoacoustic imaging|Photoacoustic imaging
15825889|NCT04237038|Procedure|laparoscopic Nissen fundoplication short gastric vessel division|Randomized clinical trial conducted in forty patients submitted to SGVD and forty patients without SGVD. Patients were evaluated with standarized questionnaires to measure the degree of satisfaction in relation to surgical procedure and to the quality of life. A randomized clinical trial was conducted with 87 patients submitted to laparoscopic Nissen fundoplication between February 2013 to december 2014 according to the guidelines established by the Mexican Consensus for the study of Gastroesophageal reflux disease (GERD
15825890|NCT04237025|Other|Nordic walking exercise|Supervised Nordic Walking (NW) exercise will be conducted in a small group setting with a 2:1 participant to trainer ratio providing individualized training instruction. Training will be conducted for a total of 14 one-hour sessions over a 6-week period. Training will take place at an outdoor community track with progression tasks on hills or grassy terrain. The one-hour training sessions will include a 10-minute warm-up period, 45 minutes of individualized NW training, and a 5-minute cool down period. The target training duration goal for NW exercise will be 45 minutes of continuous walking at moderate intensity based on target heart rate and Rating of Perceived Exertion. NW exercise program will be customized and progressed for each participant by trainers with ongoing assessment of participant's gait pattern, NW technique, and exercise responses during the training sessions. Group comradery and accountability will be facilitated through training in small group training context.
15825891|NCT04237012|Drug|Dextenza 0.4Mg Intracanalicular Insert|all patients will receive Intracanalicular dexamethasone, 0.4mg insert lower punctum and able to use over the counter artificial tears PRN at patient discretion
15825893|NCT04236999|Behavioral|Yo Sé Lo Que Quiero (YSLQQ)|"This program is organized in 12 sessions around three themes:
~Knowledge and attitudes (1 st to 4 th sessions): students reflect on their knowledge of legal and illegal drugs, using tests to reach an objective assessment of this knowledge.
~Intrapersonal skills (5 th to 6 th sessions): students reflect on normative beliefs, where perceived prevalence of drug use at students' age is compared with the actual local prevalence.
~Interpersonal skills (7 th to 12 th sessions): students are instructed to practice refusal skills, assertiveness, and analyze coping strategies. They also are instructed and practice how to make decisions using a five-step model."
15825894|NCT04236986|Drug|Lipopolysaccharide|LPS will be administered intravenously (1.0ng/kg; IV)
15825895|NCT04236973|Device|Molbio Truenat™ HCV assay (the investigational product)|The Molbio Truenat™ HCV assay (the investigational product) is a quantitative chip-based Real Time Reverse Transcription Polymerase Chain Reaction (qRT-PCR) tests for the detection of HCV genomic RNA from human whole blood, EDTA plasma and serum. The Truenat™ HCV assay runs on the Truelab™ Uno, Truelab™ Duo or Truelab™ Quadro Dx. Results of testing by Truenat™ HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.
15825896|NCT04236973|Other|Abbott RealTime HCV assay|Plasma specimens will be also tested on Abbott RealTime HCV assay that is approved for HCV diagnostics use by countries' authorities. Only the results of Abbott RealTime HCV assay may be used to make clinical decisions.
15825897|NCT04236960|Biological|Meningococcal Group ACYW135 Conjugate Vaccine|1 dose in Stage 1 (2~55 yrs), 2 doses in Stage 2 (7~23 mos), and 3 doses in Stage 3 (2&3 mos)
15825898|NCT04236947|Behavioral|SCPP-YA|SCPP-YA includes two modules. In the first module of ten sessions, students will learn to employ a 6-step social information processing framework for solving a wide range of real-life problems. The six-step process consists of 1) stop, clam down, and think before you act; 2) say the problem and how you feel; 3) set a positive goal; 4) think of many solutions; 5) think ahead to the consequences and 6) go ahead and try the best plan. The second module offers 1) current and accurate information about the health, social, and legal consequences of substance use, 2) correct mistaken beliefs that students have about substance use, 3) enhances awareness of social and media influences; and 4) teachers assertiveness and critical thinking skills to resist peer pressure.
15825899|NCT04236934|Other|Assesment of diaphragm shape and diaphragm movement (by M-mode and the AREA-method) by ultrasound before and after thoracentesis|Questionnaire is about symptoms measured by Edmonton Symptom Assessment Score (ESAS) and dyspnea also by modified Borg Scale (MBS)
15825900|NCT04236921|Drug|DopaSnap®|immediate release CD/LD 25/100mg; Riverside Pharmaceuticals Corporation, USA
15825901|NCT04236921|Drug|RDL of CD-LD|(immediate release CD/LD 25/100mg; Merck Sharp & Dohme Corp., USA),
15825902|NCT04236908|Drug|NSAIDS|Naproxen 500mg by mouth twice a day as needed.
15825903|NCT04236908|Device|Battlefield Acupuncture|"Battlefield Acupuncture in both ears (which includes the points cingulate gyrus, thalamus, omega-2, point zero and shen men).
~Battlefield acupuncture utilizes up to 10 ASP acupuncture needles (5 in each ear). The Battlefield Acupuncture points include: cingulate gyrus, thalamus, omega-2, point zero, and shen men. The semi-permanent needles are left in place and typically stay in place for 2-7 days. Needles will usually fall out on their own, can be removed by the patient or the patient can call study staff and come in for removal if desired."
15825904|NCT04236908|Device|GV26 with manual tonification|"Acupuncture to include use of GV 26 with manual tonification (twisting or rotating the needle).
~The protocol for using GV26 is as follows: With the patient in a seated position the acupuncturist places a 40mm needle in the acupuncture point GV26 (located on the philtrum, on the anterior midline, at the junction of the upper 1/3 and lower 2/3 of the distance from the nose to the margin of the upper lip). The acupuncturist then rapidly rotates the needle at the handle clockwise and counterclockwise (known as manual tonification) for 20-40 seconds at a time. The patient then stands up and assesses their pain. This will be performed up to 6 cycles. If a patient is unable to sit or stand, this may also be performed in a supine position with the patient attempting to sit or stand every 20-40 seconds."
15825905|NCT04236895|Drug|Gan & Lee Insulin Glargine Injection|All IMPs will be administered as a 0.5 U/kg single subcutaneous dose by a pre-filled pen.
15825906|NCT04236882|Behavioral|Health Education|Receive educational material on healthy homes
15825907|NCT04236882|Other|Internet-Based Intervention|Receive web-based sleep intervention
15825908|NCT04236882|Other|Internet-Based Intervention|Receive web-based health coaching sessions
15825909|NCT04236882|Other|Interview|Complete interview
15825910|NCT04236882|Other|Survey Administration|Ancillary studies
15825912|NCT04236843|Dietary Supplement|Feces|Feces from healthy donor
15825913|NCT04236830|Drug|Silver diamine fluoride/ potassium iodide|Thirty six first permanent molars will receive 38% SDF/KI as an indirect pulp capping material.
15825914|NCT04236830|Drug|Silver diamine fluoride|Thirty six first permanent molars will receive 38% SDF as an indirect pulp capping material.
15825915|NCT04236830|Drug|Resin modified glass ionomer cement|Thirty six first permanent molars will receive RMGIC as an indirect pulp capping material.
15825916|NCT04236817|Behavioral|Pre-packed blisters for distribution of medications|
15825917|NCT04236817|Behavioral|Routine distribution of medications|
15825918|NCT04236804|Device|Flowly (TMC-CP01)|TMC-CP01 is a device designed specifically for pain management and is tailored for low back pain. The treatment utilizes virtual reality and biofeedback to train patients to auto-regulate themselves and improve their pain over time guidelines.
15825919|NCT04236791|Other|ENDS (vaporizer/e-cig) and smoking cessation counseling|Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit.
15825920|NCT04236791|Other|Smoking cessation counseling|Participants in the control group will receive smoking cessation counseling only. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit.
15825921|NCT04236778|Drug|VE303|The VE303 Drug Product is a live biotherapeutic product (LBP) consisting of 8 clonal human commensal bacterial strains manufactured under GMP conditions.
15825922|NCT04236778|Drug|Oral Vancomycin|Vancomycin, when taken by mouth, is used to treat Clostridium difficile-associated diarrhea.
15825923|NCT04236765|Other|TB infection-screening benefiting group|The children who participate in the study will be recruited during a programmed visit to a traveler health clinic or a primary care center. During the first visit the parents or legal guardian will be interviewed, a questionnaire will be completed with sociodemographic, epidemiologic and clinical data and a tuberculin skin test (TST) will be performed and read at 48-72 hours. At 8-12 weeks after returning from the travel abroad the child will have a new visit. A new interview will be carried out with the parents or legal guardian and a questionnaire will be completed with epidemiological and clinical data. The child will undergo a new TST and QFT-Plus test.
15825924|NCT04236752|Radiation|Stereotactic Ablative Body Radiation (SBRT)|
15825925|NCT04236739|Drug|Instant MSC Product accompanying Autologous Chondron Transplantation|Application of a mixture of allogenic MSC's and autologous chondrons with a fibrin cell carrier (Tisseel®) in the cartilage defect of the knee during one surgical procedure.
15825926|NCT04236726|Other|Questionnaire|HRQoL questionnaires
15825927|NCT04236713|Other|Dietary intervention 1|Limiting dietary exposure to ethylenediaminetetraacetic acid, erythorbate, propionate and related food additives; limiting eating out to a maximum of 2 days per week.
15825928|NCT04236713|Other|Dietary intervention 2|Limiting dietary exposure to nitrites, sulfites and related food additives; limiting eating out to a maximum of 2 days per week; limiting drinking wine to a maximum of 2 days per week.
15825929|NCT04236700|Other|Oral clinical exam|Detailed anamnesis, with information regarding the time of sun exposure, protection measures, medical history and application of questionnaires will be carried out. Dental dental and tissue examination should be performed
15825930|NCT04236687|Device|Holmium laser enucleation of the prostate|Holmium laser will be used to enucleate the prostatic hyperplasia trough the urethra
15825931|NCT04236687|Procedure|Artery embolization of the prostate|A catheter is placed in the prostate artery, a fluid containing thousands of tiny particles (microspheres) is injected through the catheter into these small arteries which nourish the prostate
15825932|NCT04236674|Device|Buzzy thermomechanical device|Buzzy thermomechanical device placed near intervention site.
15825933|NCT04236674|Behavioral|Music Selection|Patient specified procedural music
15825934|NCT04236661|Device|chilipad|Chilipad is a commercially available pad designed to be placed between the top of a mattress and bed sheets. It allows for precise temperature regulation in one's bed.
15825935|NCT04236648|Procedure|Minimally-invasive non-surgical therapy (MINST)|subgingival root debridement with a minimally-invasive approach using piezoelectric/ultrasonic instruments
15825936|NCT04236635|Drug|EN3835|Collagenase Clostridium Histolyticum (CCH)
15825937|NCT04236622|Other|Periodontal clinical exam|"The individuals will be submitted to a complete periodontal examination, with measurements obtained at four points per tooth and dental implant (mesial, distal, buccal and lingual / palatal), in all teeth / implants present, except for the third molars, the parameters evaluated will be: Probing Depth, Clinical Insertion Level, Plaque Index, Teeth Bleeding Index. The implants will be evaluated according to the parameters: presence of suppuration, probing depth, bleeding to probing and presence of biofilm around the implants. To perform the clinical examinations, the following instruments will be required: Willians millimeter probe, exploratory probe and clinical mirror.
~In all participants, complete periapical radiographic examinations with 14 radiographs will be performed to verify the bone cortical height level and to assist in the periodontal diagnosis."
15825938|NCT04236609|Device|Abluminus DES+ Sirolimus Eluting Stent System (SES)|The Sirolimus-eluting stent manufactured by Envision and distributed by Concept Medical
15825939|NCT04236609|Device|XIENCE Everolimus Eluting Coronary Stent System (XIENCE family)|The Everolimus-eluting stent manufactured and distributed by Abbott Vascular Santa Clara, CA
15825940|NCT04236596|Device|Medtronic Interstim II Model 3058 Neurostimulator|All stimulation parameters used will be within the normal hard-coded limits of the implantable pulse generator (IPG).
15825941|NCT04236583|Other|Telehealth|Post-discharge virtual visit
15825942|NCT04236570|Device|Thermode(hot plate) and cold water bath|Standardized protocol will consisted of stimulus test (TS) generated by thermode and conditioning stimulus (CS) using cold water bath.
15825943|NCT04236570|Device|TENS(transcutaneous electrical nerve stimulation)|TENS protocol will consisted of test stimulus (TS) and conditioning stimulus (CS) both generated by TENS
15825944|NCT04236557|Behavioral|Music listening|Other than usual care, subjects will listen to a 30-min individualized playlists with preferred music genres sequenced by a registered music therapist according to the ISO-Principle when agitated.
15825945|NCT04236557|Behavioral|Audio Book Listening|Other than usual care, subjects will listen to to a 30-min audio-script of book reading in Cantonese (a common dialect in Hong Kong being spoken by most people) when agitated.
15825946|NCT04236544|Behavioral|PExMS and DECIMS-Wiki|The intervention consists of an information provision on immunotherapies as a combination of factual and experiential information. PExMS is a multimedia website providing patient experiences with MS in everyday life and with therapies illustrated by video, audio and text files of 48 persons with multiple sclerosis. The development of the intervention followed largely recommendation for standardised qualitative research provided by international DIPEx (Database of Individual Patients' Experience of illness) association, which use standardised qualitative research methods to provide 'balanced' information from original interview data. Data for the website was generated in a qualitative interview study with relapsing remitting multiple sclerosis patients across Germany. DECIMS (Decision coaching in MS)-Wiki (www.wiki2.kkn-ms.de) is an evidence-based patient information website focusing multiple sclerosis immunotherapies.
15825949|NCT04236518|Behavioral|Diets with either predominantly animal protein sources.|20 men will follow for 4 weeks a controlled diet with a protein fraction constituted mainly from animal sources. At the end of the intervention period, a post-prandial exploration will be conducted with the administration of a high-fat, high-sugar meal and subsequent blood and urine sampling.
15825950|NCT04236518|Behavioral|Diets with predominantly plant protein sources|20 men will follow for 4 weeks a controlled diet with a protein fraction constituted mainly from vegetal sources. At the end of the intervention period, a post-prandial exploration will be conducted with the administration of a high-fat, high-sugar meal and subsequent blood and urine sampling.
15825951|NCT04236505|Behavioral|Acceptance and Commitment Therapy (ACT) group based intervention|4 week ACT psychological intervention group based on Flaxman and McIntosh's ACT in the work place group format
15825952|NCT04236505|Behavioral|Mindfulness based stress reduction (MBSR) informed brief mindfulness skills group intervention|4 week Mindfulness based stress reduction (MBSR) informed brief mindfulness skills group intervention
15825953|NCT04236505|Behavioral|Wait list Control group|this group are placed on a wait list for group treatment whilst the other experimental groups run. This group are offered the MBSR based mindfulness skills once the follow up data has been collected from the other two experimental groups
15825954|NCT04236492|Procedure|Fresh osteochondral allografting|Transplantation of a fresh osteochondral allograft in the knee
15825955|NCT04236479|Biological|BM-MSC|Allogeneic bone marrow-derived mesenchymal stromal cell (BM-MSC) delivery through cardiopulmonary bypass (CPB) using a homogeneous population of infants with congenital heart disease (CHD) who will be undergoing a two-ventricle repair within the first six months of life.
15825956|NCT04236466|Device|hyrax appliance|Hyrax will be constructed with bands on maxillary first molars and wire extending on palatal surfaces of teeth till the upper canines.
15825957|NCT04236466|Device|haas appliance|Haas will be constructed with bands on maxillary first molars and wire extending on palatal surfaces of teeth till the upper canines. Acrylic part will be added on palate
15825958|NCT04236453|Drug|Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC|Participants will receive a single dose of Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC tablet orally on Day 1 of treatment periods with Treatment A.
15825959|NCT04236453|Drug|Darunavir|Participants will receive a single dose of Darunavir orally on Day 1 of treatment periods with Treatment B.
15825960|NCT04236453|Drug|Emtricitabine/Tenofovir Alafenamide|Participants will receive a single dose of Emtricitabine/Tenofovir Alafenamide tablet orally on Day 1.
15825961|NCT04236453|Drug|Cobicistat|Participant will receive a single dose of Cobicistat tablet orally on Day 1.
15825962|NCT04236440|Drug|BAY2586116 (A1)|160 μg BAY2586116 (nasal spray administration)
15825963|NCT04236440|Drug|Placebo (A2)|Placebo matching BAY2586116 (nasal spray administration)
15825964|NCT04236440|Drug|BAY2586116 (B1)|160 μg BAY2586116 (nasal drops)
15825965|NCT04236440|Drug|BAY2586116 (B2)|80 μg BAY2586116 (nasal spray)
15825966|NCT04236440|Drug|BAY2586116 (B3)|160 μg BAY2586116 (pharyngeal spray with direct endoscopic application via a nostril)
15825967|NCT04236440|Drug|BAY2586116 (C)|160 μg BAY2586116 (pharyngeal spray with direct endoscopic application via a nostril). It is the same procedure as described under part B3.
15825968|NCT04236427|Drug|Angong Niuhuang Wan|Angong Niuhuang Wan 3g
15825969|NCT04236427|Drug|Angong Niuhuang Wan Placebo|Angong Niuhuang Wan Placebo 3g
15825971|NCT04236401|Procedure|electrosurgery will be used for abdominal incision|electrosurgery will be used to open anterior abdominal wall and electrosurgery will be used for heamostasis also
15825972|NCT04236401|Procedure|scalpel will be used for abdominal incision|scalpel will be used for abdominal wall incision and thread will be used for haemostsis
15825973|NCT04236388|Dietary Supplement|Ketone drink|Pre- and post-testing will be completed before and after participants receive 42 doses of ketone supplement drink over a 2-week period (3x/day for 14 days).
15825974|NCT04236388|Dietary Supplement|Placebo drink|Pre- and post-testing will be completed before and after participants receive 42 doses of placebo supplement drink over a 2-week period (3x/day for 14 days).
15825975|NCT04236362|Drug|TQB2450|TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
15825976|NCT04236362|Drug|Anlotinib|A multi-target receptor tyrosine kinase inhibitor
15825977|NCT04236349|Genetic|immunogenetics|blood samples at day 0, week 2, month 2; at the end of treatment (month 6 or month 9 or month 12 depend on treatment duration)
15825978|NCT04236336|Device|TSV dental implant|Qualified patient will be those patients who have been newly diagnosed with needing a dental implant (or more than one) in one or more edentulous areas in the maxilla and/or mandible.
15825979|NCT04236323|Drug|Not used remifentanil infusion|Remifentanil is not used during operation
15825980|NCT04236310|Drug|SHR6390|SHR6390 150 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment for 4 cycles
15825981|NCT04236310|Drug|Anastrozole|Anastrozole 1md, orally once daily for 16 weeks (For premenopausal women, ovarian suppression may be considered)
15825982|NCT04236310|Drug|Pyrotinib|Pyrotinib 400mg once daily for 16 weeks
15825983|NCT04236310|Drug|Trastuzumab|Trastuzumab 6mg/kg (loading dose, 8mg/kg), infusion once every 3-week cycle for 5 cycles.
15825984|NCT04236297|Device|bite block|Physicians performing transesophageal echocardiogram in patients under sedation or general anesthesia will use either standard or modified bite block.
15825985|NCT04236284|Device|Home-based tDCS|tDCS is a non-invasive neuromodulation technique that has been used to improved cognitive functions. It will be administered with a constant current intensity of 2 mA57 for 20 min per session/ 10 sessions total daily for 2 weeks (Monday to Friday). The device is a Soterix 1x1 tDCS mini-CT Stimulator (Soterix Medical Inc., NY) with headgear and 5 _ 7 cm saline-soaked surface sponge electrodes.
15825986|NCT04236284|Behavioral|Prolonged Exposure Therapy|Prolonged Exposure Therapy is a treatment for PTSD that includes the following components: a) psycho-education about the common reactions to traumatic events and presentation of the treatment rationale (sessions 1 and 2), b) repeated in vivo exposure to traumatic stimuli (in vivo exercises are assigned as homework during sessions 3 through 11), c) repeated, prolonged, imaginal exposure to traumatic memories (imaginal exposure is implemented during sessions 3 through 11; patients listen to session audiotapes for homework between sessions), and d) relapse prevention strategies and further treatment planning (session 12).
15825987|NCT04236271|Device|connected objects|a combination of connected devices for measuring physiological parameters and for clinical self-assessment by the patient, for early postoperative coronary bypass surgeries.
15825988|NCT04236258|Drug|NIFEdipine ER|Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive.
15825989|NCT04236258|Drug|Enalapril|Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.
15825990|NCT04236245|Device|Venclose RF System|Treatment of great saphenous vein (GSV) using Venclose RF System
15825991|NCT04236232|Diagnostic Test|Thyroid function|Thyroid function,Lipid Profile, systolic Blood pressure ,diastolic blood pressure .Body Mass Index ,CRP,Echocardiography،ECG, Ultrasonography of Carotid artery
15825992|NCT04236219|Drug|ALLN-346|ALLN-346 is novel urate oxidase provided as capsules for oral administration. Single ascending doses within 3 sequential cohorts: Cohort A - 3 capsules administered once, Cohort B - 6 capsules administered once and Cohort C - 12 capsules administered as 6 capsules twice on 1 day.
15825993|NCT04236219|Drug|Placebo|Matching placebo capsules for oral administration. Single ascending doses within 3 sequential cohorts: Cohort A - 3 capsules administered once, Cohort B - 6 capsules administered once and Cohort C - 12 capsules administered as 6 capsules twice on 1 day.
15825994|NCT04236206|Behavioral|Mobile Phone Short Message Service|"SMS content will be adopted from the validated Arabic national and international diabetes educational materials (Centers for Disease Control (CDC), 2018; Diabetes Australia, 2004; Diabetes Queensland, 2012; Utah Diabetes Control Program, 2005).
~The mobile phone SMSs will be pre-tested for clarity on a sample of 10 patients similar to the study population and their comments on the SMSs wording will be used to modify them to ensure acceptance.
~The SMS will be sent to participants using the internet, open-source software for bulk messages and a local telephone network provider.
~Patients will be encouraged to send messages/call the researcher for any queries encountered."
15825995|NCT04236193|Diagnostic Test|Ultrasound Shoulder and Immunological Phenotyping by FACS|Cross-sectional Ultrasound exam of the affected shoulder. Peripheral blood measurements of the T and B cell subsets. Anti-Influenza Antibody measurements
15825996|NCT04236180|Other|Specialised Peadiatric Palliative Care (SPPC)|All services provided to children/families by a member of the multiprofessional SPPC team in Zurich according to local guidelines will be considered as study intervention. This includes direct consultation of the patient/family, as well as patient-/family-related consultation of the frontline care team. Bereavement support is considered an integrated part of SPPC and after the death of a child, follow-up bereavement support is routinely offered at the individual or group level as appropriate for parents and siblings.
15825997|NCT04236167|Device|Fractional CO2 laser treatment -|UltraPulse CO2 Laser (Lumenis, Israel). Patients will receive laser treatments at 4 to 8-week intervals for a total of 3 sessions. A combination of the SCAAR FX and Deep FX treatment modes, with or without Active FX treatment mode, will be used according to individual patient and scar characteristics. For SCAAR FX, the settings include energy (70-150mJ), density (1-5%), and frequency (150-250Hz).For Deep FX, the settings include energy (12.5-22.5mJ), density (5-15%) and frequency (300-600Hz). For Active FX, the settings include energy (80-125mJ), density (2-3%) and frequency (100-150Hz)
15825998|NCT04236154|Other|Pedometer|Participants will wear a pedometer for 4 days at baseline, and 4-6 weeks later. Baseline readings will be used to derive an individualized exercise program for each participant based on their assigned experimental arm.
15825999|NCT04236154|Other|Actigraph|Participants will wear a Actigraph for 4 days at baseline and 4-6 weeks later. Baseline readings will be used to derive an individualized exercise program for each participant based on their assigned experimental arm.
15826000|NCT04236154|Other|Perturbation Treadmill|Participants will walk on an instrumented treadmill while wearing a safety harness at baseline and 4-6 weeks later. The perturbation treadmill will assess an individual's risk for falling. Baseline readings will be used to derive an individualized exercise program for each participant based on their assigned experimental arm.
15826001|NCT04236141|Drug|Polatuzumab Vedotin|Participants will receive a total of 6 cycles (a cycle being 21 days) of 1.8mg/kg Polatuzumab Vedotin (IV infusion) on Day 2 of Cycle 1 and Day 1 of Cycles 2-6.
15826002|NCT04236141|Drug|Bendamustine|Participants will receive a total of 6 cycles (a cycle being 21 days) of 90 mg/m2 Bendamustine (IV infusion) on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6.
15826003|NCT04236141|Drug|Rituximab|Participants will receive a total of 6 cycles (a cycle being 21 days) of 375 mg/m2 Rituximab (IV infusion) on Day 1 of each cycle.
15826004|NCT04236141|Drug|Placebo|Participants will receive a total of 6 cycles (a cycle being 21 days) of Placebo (IV infusion) on Day 2 of Cycle 1 and Day 1 of Cycles 2-6.
15826033|NCT04235894|Drug|Propofol|Intravenous anesthesia with propofol started with 0.5 mg kg-1, and was titrated until a patient was unresponsive to painful stimuli & maintaining spontaneous breathing during gastrointestinal endoscopy
15826034|NCT04235881|Behavioral|Mindfulness-based stress reduction program|Mindfulness training through an adaptation of the standardized MBSR program. This program was conducted in person and in a group, with a maximum of 25 participants per group and a total duration of 8 weeks. The training was carried out in 8 sessions, one each week, with a duration of 2 h each session.
15826063|NCT04235634|Drug|Prostavasin|Minimal invasive Cannulation of the Superior Mesenteric Artery (SMA) and subsequent intra-arterial application of prostaglandin E1 (Initial Bolus 20ug, followed by continuous Infusion of 60-80ug/24hr for 24-72hrs)
15826005|NCT04236128|Other|Mobile App|"The app will be provided to patients in hospital on post-operative day 3. On the day of discharge, the patient will be emailed a Daily Health Check and receive subsequent Daily Health Check emails on Day 1-14, 21 and 30 days following discharge. The Daily Health Check is a tailored questionnaire to elicit their symptoms and status of post-operative recovery. After the patient has completed the Daily Health Check, a Daily Health Check Summary is emailed to the patient that summarizes their responses and provides appropriate action recommendations based on their responses ranging from: (i) suggestions for educational modules, (ii) expect a call from your health care team in the next 24 hours, (iii) call your surgeon's office today or (iv) go to the nearest emergency room. The patient's Daily Health Check responses are displayed in real time on a secure website that automatically red flags extreme responses to alert the health care team to contact the patient by telephone."
15826006|NCT04236115|Drug|Articaine 4%|Articaine 4% is dental local anaesthetic agent
15826007|NCT04236115|Drug|Prilocain 3%|prilocaine is dental local anaesthetic agent
15826008|NCT04236115|Drug|Adrenalin|adrenaline is a vasoconstrictor
15826009|NCT04236115|Drug|Felypressin|Felypressin is a vasoconstrictor
15826010|NCT04236102|Diagnostic Test|Biocartis Idylla platform - real time PCR detecting EGFR, KRAS and BRAF mutations in liquid based cytology and blood plasma samples|Automated real time PCR mutation analysis - 1. Can the Idylla platform provide a standardised and effective method for detecting EGFR, KRAS and BRAF mutations in blood and liquid based cytology samples for patients with lung and pancreatic cancer. Mutation detection increases the treatment options for patients.
15826011|NCT04236089|Device|robotic hand|mirror therapy with robotic hand
15826012|NCT04236076|Device|PulseHaler|PulseHaler™ is a pulsating positive expiratory pressure ventilation device for treatment of COPD. PulseHaler™ is pre-programmed to deliver airflow at pre-defined frequencies, ranging from 3.5 Hertz (Hz) to 55Hz, and for pre-defined lengths of time.
15826013|NCT04236076|Device|Sham - control|Sham device has the same look as PulseHaler and is set to deliver nominal pressure but it does not contain the active pulsating components.
15826014|NCT04236063|Other|WHODAS 2.0 Questionnaire|36-item WHODAS 2.0 questionnaire will be used for each patient to identify difficulty faced by patient over past 30 days from the day of interview
15826015|NCT04236050|Drug|Rocuronium|Rocuronium administered in continuous infusion or multiple bolus doses
15826016|NCT04236037|Procedure|ultrasound-guided pleural biopsy|Using ultrasound the optimal point of entry for thoracentesis is located. Local anesthesia is obtained with 10 mL of 2% lidocaine with adrenalin injected in cutis, subcutis, muscle and pleura. Before removing the syringe, aspiration of pleural fluid confirms the relevance of the chosen site . Again, the area is wiped with disinfectant and a millimeter small skin incision is made with a pointed scalpel. Six US-guided biopsies of 1.2 millimetres using closed needle biopsies (Quick-core Biopsy Needle 18G, COOK Medical, Bloomington, Indiana, USA or Bard Max Core needle 18G, Temple, Arizona, USA). ) are taken from the parietal pleura. Thoracentesis is performed as described above using the same incision as the pleural biopsy.
15826017|NCT04236037|Procedure|Thoracentesis|The optimal point of entry (the largest distance between parietal and visceral pleura) is identified using ultrasound. This is usually on the lower, dorsal side of the chest. Local anesthesia is obtained with 10 mL of 2% lidocaine with adrenalin injected in cutis, subcutis, muscle and pleura. Before removing the syringe, aspiration of pleural fluid confirms the relevance of the chosen site. The area is wiped with disinfectant and a millimeter skin incision is made with a pointed scalpel. A 7 French (or up to 16 French, to the choice of the clinician) pigtail catheter is inserted and connected to sealed bag. Fluid is aspirated via a 3-way valve, and transferred to relevant bottles for culture, analysis of albumin and LDH, protein, and for cytology.
15826018|NCT04236024|Other|Board game|The students in the experimental group will play board game to learn medication about 30-60 minutes.
15826019|NCT04236024|Other|Traditional lecture|The students in the comparison group will receive medication lecture using PPT slides about 30-60 minutes.
15826020|NCT04236011|Biological|GC012F injection|GC012F injection is a autologous dual CAR-T targeted BCMA and CD19. A single infusion of CART cells will be administered intravenously.
15826021|NCT04235998|Diagnostic Test|Systematic lung ultrasound|"Patients will undergo a systematic lung ultrasound including review of:
~Sonographic characteristic of effusion
~Parietal, diaphragmatic and visceral pleura
~Pleural nodules
~Lung parenchyma
~Extra pulmonary findings: Hepatic pathology, enlarged lymph nodes of the neck and a cardiac assessment."
15826022|NCT04235985|Combination Product|Chlorhexidine Gluconate with HUBS|4% CHG soap will be applied to HUBS following manufacturers recommendation and applied to skin for different application times as dictated by the randomization of the marked sites on the forearm. Followed by a HUBS moistened with water.
15826023|NCT04235972|Other|Follow-up consultation|A follow-up consultation is organized which includes: A clinical examination with standard data collection as well as a face and profile radiograph of the operated wrist.
15826024|NCT04235959|Drug|Tirzepatide|Administered SC
15826025|NCT04235959|Drug|Placebo|Administered SC
15826026|NCT04235946|Other|accompanied and adapted water polo program|"Validated questionnaires in French will measure fatigue, quality of life, post-traumatic growth and the coach-athlete relationship. All questionnaires will be administered face to face before the sessions by a member of the social psychology research team.
~The collection of qualitative data (semi-structured interviews) will be carried out by one of the members of the research team in social psychology on three occasions (inclusion, Week 10 and Week 20) in order to assess the psychological variables of interest (quality interpersonal relationships, self-esteem, post-traumatic growth) and their dynamics.
~Physiological variables (weight, fat / lean mass, capacity of the operated arm) will be evaluated monthly. The physical measurement data will be recorded in an electronic case report form"
15826027|NCT04235933|Biological|Tai Ai(RC18) 80mg|The patient received one treatment of RC18 80mg in the test group
15826028|NCT04235933|Biological|Tai Ai(RC18) 160mg|The patient received one treatment of RC18 160mg in the test group
15826029|NCT04235933|Biological|RC18 240mg|The patient received one treatment of RC18 240mg in the test group
15826030|NCT04235920|Diagnostic Test|Montreal Cognitive Assessment (MoCA)|This scale evaluates different domains of cognition like attention, orientation, memory, language, visuoconstructional capacities, and lastly, executive functions. MoCA is a thirty point test with a score of 25 or less considered as abnormal impaired cognition
15826064|NCT04235621|Other|FSGS/TR-MCD|This is a non-interventional study
15826035|NCT04235881|Behavioral|App REM volver a casa|"The intervention was carried out through the computer application for mobile phone REM volver a casa. This application has been developed to carry out training in the emotional regulation program based on mindfulness, autonomously. The application is designed to carry out the program in 8 weeks."
15826036|NCT04235868|Biological|Stem cell-derived derived pleiotropic factor|After debridement, the wounds in experimental group apply stem cell-derived lyophilized powder, and use foam dressing to wrap the wound; apply once every 2-3 days.
15826037|NCT04235868|Biological|fibroblast growth factor|After debridement, the wounds in control group apply fibroblast growth factor to the wound surface, and use foam dressing to wrap the wound; apply once every 2-3 days.
15826038|NCT04235855|Device|Endoscopic USG guided Liver biopsy|Diagnostic yield with EUS guided liver biopsy - Left lobe Bx vs combined right and left lobe or vs right lobe would be assessed.
15826039|NCT04235855|Device|Percutaneous Liver Biopsy|All liver biopsies done in the Institute as routine procedure by percutaneous route would be compared with the EUS guided biopsy in respect to safety , tissue quality and diagnostic yield .
15826040|NCT04235842|Other|Physical Exercise|Moderate-intensity continuous exercise training performed at cycle ergometer.
15826041|NCT04235842|Other|High-intensity interval training performed at cycle ergometer.|High-intensity interval training performed at cycle ergometer.
15826042|NCT04235829|Procedure|Laparoscopic sleeve gastrectomy|Form of obesity surgery
15826043|NCT04235816|Drug|Azithromycin|Administration of azithromycin during the first 15 months of life through the Expanded Program on Immunisation
15826044|NCT04235816|Drug|Placebo|Administration of placebo during the first 15 months of life through the Expanded Program on Immunisation
15826045|NCT04235803|Other|Telemedicine follow-up|A telemedicine follow-up form based in REDCap that collects information from the patient including: history, photographs, vision measurement, and questions.
15826046|NCT04235790|Device|Eye Tracking Device|Eye tracking glasses
15826050|NCT04235751|Behavioral|Professional Coaching|6 individualized professional coaching sessions via phone
15826051|NCT04235738|Other|Observational|"ER2 is a simple and standardized clinical tool. The results of the questionnaires performed in ER2 study will be used. The assessment component of ER2 consists of 6 very simple closed-ended format questions (i.e., yes versus no) which are: Age category (≥ 85), male, polypharmacy (≥ 5 different medications per day), use of formal (health care or social professional) and/or informal (family and/or friend) home support, use of a walking aid regardless of its type, and temporal disorientation (inability to give the current month and/or year). A score of five points is assigned to the items use of walking aid and temporal disorientation, whereas, for the other items, the assigned score is one point. The weighting of points for ER2 items is based on the results of our previous studies. Scores range from 0 (lowest risk) to 14 (highest risk). ER2 scores stratify the risk for short-term ED adverse events into three levels: low, moderate and high."
15826052|NCT04235725|Other|Harmonized Depression Outcome Measures|This is an observational study where retrospective data on previous disease status and patient characteristics will be collected and combined with longitudinal data from these data sources on outcomes during the study timeframe.
15826053|NCT04235712|Other|Harmonized Depression Outcome Measures|This is an observational study where outcome measures will be extracted from patients' medical records and from questionnaires to provide information back to the clinician.
15826054|NCT04235699|Other|Nutritional and Dietary Manipulation|Participants will undertake a controlled feeding intervention. All food will be prepared and delivered to participants by research staff. Participants will be asked to exclusively eat what is provided to them in efforts to control any dietary effects.
15826055|NCT04235686|Drug|Mydayis Extended-Release Capsule|Randomized, parallel - group, double-blind, placebo-controlled, flexible-dose adjunctive trial of MYDAYIS®
15826056|NCT04235686|Drug|Placebo|Matching placebo
15826057|NCT04235673|Dietary Supplement|melatonin|orally administered drops
15826058|NCT04235673|Drug|placebo|orally administered drops
15826059|NCT04235660|Radiation|Yttrium-90 Radiation Segmentectomy|This therapy arm involves two separate steps, a planning/mapping arteriogram and a therapy delivery. The planning arteriogram will be performed to confirm arterial anatomy is acceptable for RS (≤2 segment delivery) and that lung shunting is not too high to preclude treatment with RS. Once confirmed, patients will return for RS (within 45 days of mapping). Dose will be calculated based off the desired treatment volume using pre-treatment cross-sectional imaging. The desired segmental dose will be calculated to be ≥ 200Gy. RS will be performed by one of three separate interventional radiologists with experience in radioembolization. Actual administered activity and location of dose administration will be recorded.
15826060|NCT04235660|Radiation|Stereotactic Body Radiation Therapy|SBRT will be delivered with linear accelerator-based photon beams with either fixed angle non- coplanar fields or dynamic arcs. An internal target volume (ITV) will be generated to account for tumor movement during breathing cycle. Finally, a planning target volume (PTV) will be an expansion of 3- 5mm from the ITV. For Child Pugh A patients, prescription dose will either be 5000cGy in 5 fractions delivered every other day or 4800cGy in 3 fractions delivered twice weekly. For Child Pugh B patients, prescription dose of 4000cGy in 5 fractions delivered every other day. Inverse planning will be used. 95% of the PTV or more will receive at least 100% of the prescription dose. Normal tissue dose constraints for each dose level will be respected with acceptable deviations permitted as outlined in appendix VII. Patients will be seen at least once per week by a clinician to grade toxicities, with on- treatment labs (CBC, CMP, INR) each week.
15826061|NCT04235647|Other|Nurse led tutorial on lifestyle management and pedometer hand-out|Individual 10-minute nurse-led tutorial with distributed handouts on the health benefits of regular physical activity and pedometer hand-out
15826062|NCT04235647|Other|Steps goal setting and supporting phone calls|A goal of minimum 7000 steps per day, phone calls to assess the goal meeting and to support goal achievement every 2 weeks
15826065|NCT04235621|Other|Diabetic Nephropathy (DN)|This is a non-interventional study
15826068|NCT04235595|Other|Connective Tissue Manipulation|The application was delivered with the participant in a sitting position, with the entire back and sacral regions left exposed. The treatment was administered to the sacral, lower thoracic and pelvic regions.
15826069|NCT04235595|Other|Transcutaneous Electrical Nerve Stimulation|TENS was administered with the participant lying face down with a flat cushion underneath the abdomen. TENS was administered via 2 channels of electrodes placed with the sacral region in the middle. The intensity of the current was increased until the participant felt it.
15826070|NCT04235582|Behavioral|App + Inputs Contingency Management|The app has programmed contingencies whereby incentives can be earned for behaviors that are inputs to abstaining from drug use (e.g., attending psychotherapy or taking SUD psychopharmacology).
15826071|NCT04235582|Behavioral|App + Outcomes Contingency Management|The app has programmed contingencies whereby incentives can be earned for outcomes of abstaining from drug use (e.g., drug-negative saliva samples on saliva opioid tests).
15826072|NCT04235569|Drug|Warfarin Sodium 5 MG|warfarin sodium 5mg tablets
15826073|NCT04235569|Drug|Warfarin Sodium 3 MG|warfarin sodium 3mg tablets
15826074|NCT04235569|Drug|Enoxaparin Sodium 100 MG/ML Prefilled Syringe|"Clexane® Syringes 2,000 IU (20 mg)/0.2 ml solution for injection in pre-filled syringes.
~Clexane® Syringes 4,000 IU (40 mg)/0.4 ml solution for injection in pre-filled syringes.
~Clexane® Syringes 6,000 IU (60 mg)/0.6 ml solution for injection in pre-filled syringes.
~Clexane® Syringes 8,000 IU (80 mg)/0.8 ml solution for injection in pre-filled syringes.
~Dose was determined individually for each patient as 1mg/kg every 12 hours."
15826075|NCT04235556|Behavioral|Care pathway unit|Patients from the prospective cohort will have their health care scheduled by the care pathway unit.
15826076|NCT04235517|Other|Temporary hemi-epiphysiodesis or epiphysiodesis|Tension band plate (eight-plate, pedi plate), staple or locking plate
15826077|NCT04235504|Other|MDI|Subject continues their standard Multiple Daily Injections therapy with FGM or RT-CGM
15826078|NCT04235504|Device|AHCL|"Subject starts using the Advance Hybrid Close Loop (AHCL) MiniMed™ 670G system version 4.0.
~Starting time depends on which Arm the subject is assigned to: if the subject is assigned to the Treatment Arm, then the intervention starts after the RUN-IN period. If the subject is assigned to the Control Arm the intervention will start after 6 months from the date of the enrollment."
15826079|NCT04235478|Drug|Combination Product: triamcinolone and saline|a mixture of 3 mL 0.09%saline and 2 mL 80 mg triamcinolone (kenacort-a)
15826080|NCT04235465|Other|Dynamic Gait Index|The Dynamic Gait Index (DGI) measures functionality and dynamic balance in walking and stair climbing. The DGI consists of 8 items including normal gait on flat ground, gait with speed changes, gait with horizontal head movements, gait with vertical head movements, gait and pivot turn, gait and step over an obstacle, gait around obstacles and steps up and downstairs. The performance on each item is rated on a 4-point scale ranging from 0 (severe disorder) to 3 (independent walking). The total score is 24.
15826081|NCT04235452|Diagnostic Test|Somatosensory evoked potential|"Stimulation of the right and left median nerves for each subject were carried out with electrical square wave pulses of 0.2 ms duration applied at a rate of 5 HZ. with cathode proximally. The intensity of the stimulus was adjusted to produce minimal twitches of the thumb (1-2 cm thumb movement). Five hundred (500) stimuli were delivered. The recording electrode picked up the responses. They were then summated and averaged.
~The final evoked potential was then displayed on the screen. When two reproducible SEPs responses were obtained the data was accepted for analysis. The graph was printed out on paper, for the purpose of simplification only one response was printed out."
15826082|NCT04235439|Drug|Gan & Lee Insulin Lispro Injection|All three IMPs will be administered as a 0.2 U/kg single dose subcutaneously in the periumbilical area by use of a disposable prefilled pen.
15826083|NCT04235426|Drug|30 patients received conventional medical treatment (NSAIDs, diclofenac 150 mg/day for 2 weeks and 1500 g vitamin B 12 per day for 6 weeks) and hand support.|30 patients received conventional medical treatment (NSAIDs, diclofenac 150 mg/day for 2 weeks and 1500 g vitamin B 12 per day for 6 weeks) and hand support.
15826084|NCT04235426|Procedure|30 patients went to surgical procedure|30 patients went to surgical RELEASE OF TRANSVERSE VOLAR LIGAMENT.
15826085|NCT04235426|Other|Injection|Thirty patients were injected in the carpal tunnel with a of single ultrasound-guided Platelet Rich Plasma (1-2 ml) injections treatments
15826086|NCT04235413|Behavioral|Real-Time Incentives Group|The use of a novel computer program with a mobile phone interface to provide real-time financial incentives at the point of purchase for discounts on fruit and vegetables in low-income families. This intervention will be applied to subjects randomized to the intervention arm. They will receive 50% off eligible fruits and vegetable products at the point of purchase, up to $10 a week for 6 months. Maximum amount they can receive is $260 in discounts over the 6 month period.
15826087|NCT04235400|Diagnostic Test|No Dye BreakUp Time|Measurement without dye of the tear meniscus height (TMH) which give an rapid hint on the quantity of tears present on the ocular surface, the measure in real time of the tear osmolarity and, at last, the analysis of the thickness of the tear's layer by interferometry (measurement of the light fringes reflected by the tears when illuminated with polarized light, whereby the complete layer or the lipid layer alone can be evaluated separately depending on the machines used) and of the assessment of the quality of the Meibomian glands (non-contact imaging by infrared illumination).
15826088|NCT04235374|Behavioral|FFC-AC-EIT|The two intervention arms will receive the same educational information. The education group will not be exposed to any other activities. The FFC-AC-EIT will focus strongly on motivation of staff and patients to get the patients engaged in functional and physical activities.
15826089|NCT04235361|Diagnostic Test|Differential RPA tests|The mobile diagnostic suitcases will be deployed at Ebola Treatment centres in DRC. Samples of patients refered for diagnostic testing will be tested by PCR by existing diagnostic teams, and will be additionally tested by the mobile suitcase laboratory using differential RPA tests for 6 parameters.
15826090|NCT04235335|Behavioral|Indigenous Mother's Empowerment Program & Indigenous Kid's Club Program|Weekly groups administered to mothers and children simultaneously but separately for 10 weeks
15826117|NCT04235114|Drug|1 mg 89Zr-DFO-Nimotuzumab|A maximum of 2 mCi (range 1 - 2 mCi) 1 mg of 89Zr-DFO-nimotuzumab will be injected intravenously over a period of at 2 - 3 minutes. Injection will be followed by a normal saline flush of 20-30 mL. PET/CT scan will be done at different time points post infusion.
15826091|NCT04235322|Drug|2LHERP®|The treatment schema consists in taking the content of one capsule a day, 15-30 minutes before breakfast, on an empty stomach, sequentially, according to capsules' numerical order: 1 through 10. When capsule number 10 is taken, capsule 1 of the next blister should be taken on the next day to continue the treatment. The duration of treatment will be 6 months of continuous intake of the content of 1 capsule/day.
15826092|NCT04235322|Drug|Placebo|The treatment schema consists in taking the content of one capsule a day, 15-30 minutes before breakfast, on an empty stomach, sequentially, according to capsules' numerical order: 1 through 10. When capsule number 10 is taken, capsule 1 of the next blister should be taken on the next day to continue the treatment. The duration of treatment will be 6 months of continuous intake of the content of 1 capsule/day.
15826093|NCT04235296|Biological|epidermal growth factor|Residual wounds from the same person were divided into control group and experimental group. The epidermal growth factor is used to control group. Then the foam wound dressing was selected to cover the residual wound, and the dressing was changed every 2 days.
15826094|NCT04235296|Biological|mesenchymal stem cell conditioned medium-derived pleiotropic factor|Residual wounds from the same person were divided into control group and experimental group. The pleiotropic factor is used to control group. Then the foam wound dressing was selected to cover the residual wound, and the dressing was changed every 2 days.
15826095|NCT04235283|Device|Primary total knee replacement by pinless navigation (Orthomap Express,Stryker, Michigan)|The varus/valgus, extension/flexion, thickness of distal cut of femur was determined and done by pinless navigation system. After cutting, the instant information of resection level can show on the display screen. If the alignment is satisfying, the anterior/posterior femoral cut, chamfer cut and box resection were done by conventional jig
15826096|NCT04235283|Procedure|Primary total knee replacement by traditional jig and minimally invasive technique|The femoral alignment was determined by intramedullary guide. The femoral alignment jig was set to 5-7 degree valgus dependent on the preoperative radiograph. A bone plug is impacted into the entry hole of femoral medullary canal before prosthesis placement.
15826097|NCT04235270|Combination Product|FDC of Macitentan and Tadalafil|Fixed dose combination (FDC) of 1 film-coated tablet containing 10 mg of macitentan and 40 mg of tadalafil will be administered orally.
15826098|NCT04235270|Drug|Macitentan|Macitentan 10 mg tablet will be administered orally as free combination.
15826099|NCT04235270|Drug|Tadalafil|Tadalafil 40 mg tablet will be administered orally as free combination.
15826100|NCT04235257|Biological|HPV vaccine|Gardasil 9 Bivalent HPV VLP Vaccine, one-fifth dose Nonavalent HPV VLP Vaccine, one-fifth dose
15826101|NCT04235244|Other|Thermo mechanical device|The thermomechanical-analgesia device will be placed and operated 30 seconds before the injection into the abdominal area,and injection will be applied by sliding the device to the side of the selected region during the injection,
15826102|NCT04235244|Other|local coolant spray|Coolant spray will be applied to the abdominal area for 5 seconds at a distance of 15 cm.
15826103|NCT04235244|Other|ıce battery|abdominal bölgeye uygulamadan önce ve sonra 5 dk. lokal soğuk uygulama
15826104|NCT04235231|Device|Bed tilting|15° lateral tilt, original product brand name LINET Eleganza 5
15826105|NCT04235231|Other|Body positioning|Manual positioning of body by nurse: left side, back, right side, using positioning pillows
15826106|NCT04235205|Drug|Elobixibat 10mg + cholestyramine powder 9g (cholestyramine 4g)|Patients with nonalcoholic fatty liver disease are administered Elobixibat 10mg + cholestyramine powder 9g (cholestyramine 4g) for 16 weeks
15826107|NCT04235205|Drug|Elobixibat 10mg + cholestyramine powder placebo|Patients with nonalcoholic fatty liver disease are administered Elobixibat 10mg+ cholestyramine powder placebo for 16 weeks
15826108|NCT04235205|Drug|Elobixibat placebo + cholestyramine powder 9g (cholestyramine 4g)|Patients with nonalcoholic fatty liver disease are administered Elobixibat placebo+ cholestyramine powder 9g (cholestyramine 4g) for 16 weeks
15826109|NCT04235205|Drug|Elobixibat placebo + cholestyramine powder placebo|Patients with nonalcoholic fatty liver disease are administered Elobixibat placebo+ cholestyramine powder placebo for 16 weeks
15826110|NCT04235179|Radiation|SABR|SABR to a dose of 30Gy/5 to the pelvis (vaginal and paravaginal tissues as well as regional lymph nodes)
15826111|NCT04235166|Other|Current risk scores|Current risk scores for assessing the prognosis of acute upper gastrointestinal bleeding in cirrhosis were used.
15826112|NCT04235166|Other|New risk scores|New risk scores for assessing the progress of acute upper gastrointestinal bleeding in cirrhosis was used.
15826113|NCT04235153|Other|Evaluation of the 9 dimensions of the CANUT-QVA questionnaire|"Evaluation of the contribution of a new questionnaire by patients with solid or hematological cancer according to 9 dimensions:
~Making food
~Place where the meals are eaten
~Eating and drinking: Nutrition
~Eating and drinking: The pleasure of tasting, chewing
~Eating and drinking: Satiated, well being
~Food preparation: Supply, choice, presentation
~Eating and drinking: Feelings
~After eating: heaviness, discomfort, hunger
~Taste/Odour Problems to confirm the number and structure of factors obtained at the end of the pre-study and to remove redundant questions."
15826114|NCT04235140|Drug|LUM/IVA|LUM/IVA granules for oral administration
15826115|NCT04235127|Other|sociodemographic variables, somatic conditions, mental disorders, treatment and drug use|"sociodemographic variables
~history of self-injurious behaviours; all types of somatic conditions; neurodevelopmental, mental, behavioural, personality and substance use disorders; all types of medical procedures performed; and number and type of healthcare contacts.
~prescriptions for psychopharmacological products
~the Suicidal Scale of the Mini-International Neuropsychiatric Interview, the type and lethality of the attempt that warranted evaluation, presence and type of mental disorder, hopelessness, impulsivity, aggressiveness, altered state of conscience, use or dependence of alcohol, use or dependence of illicit drugs, serious somatic disease (including chronic diseases, chronic pain, and disabilities), living status, presence of family or social support, social problems, stressful life events, access to lethal means, and family history of suicide"
15826116|NCT04235114|Drug|50 mg 89Zr-DFO-Nimotuzumab|A maximum of 2 mCi (range 1 - 2 mCi) 50 mg of 89Zr-DFO-nimotuzumab will be injected intravenously over a period of at 2 - 3 minutes. Injection will be followed by a normal saline flush of 20-30 mL. PET/CT scan will be done at different time points post infusion.
15826118|NCT04235101|Drug|SYD985 + Niraparib|SYD985 powder for concentrate for solution for infusion Niraparib 100 mg per hard capsule
15827120|NCT04227327|Drug|Aromatase Inhibitors|Letrozole 2,5 mg daily or Anastrozole 1 mg daily
15826119|NCT04235088|Other|Somatosensory intensive intervention|The intensive somato-sensory intervention will take place during 3 weeks, 5 days per week, for 2 hours per day (30 hours of practice). During the week-ends, some somato-sensory written activities will be explained and handed to each family (6 hours of practice) Therapy sessions will be carried out in groups and each child will have his or her own therapist in charge of his or her treatment along the whole intervention. A daily check-list, design for that purpose, will be used by the therapist in order to register the gradually increased complexity of the activities and individual progression. The principal investigator will supervise all the interventions in order to assure their uniformity, adjusting the somato-sensory training protocol to the individual needs of each subject.
15826120|NCT04235075|Device|ECG/PCG and ultrasound signal acquisition|"The ECG - PCG signals are acquired over a 20-minute monitoring phase with passive non invasive sensors (abdominal and thoracic). The volunteer's abdomen is photographed when the electrodes and sensors are installed. An ultrasonography is also performed for 10 minutes.
~The session is filmed for 5 volunteers accepting the video. Any distinctive elements will be removed from photos and videos to prevent the identification of participants."
15826121|NCT04235062|Drug|Ringer's (8.6 g/L sodium chloride, 0.33 g/L calcium chloride, 0.3 g/L potassium chloride) Solution|A 2-hour of infusion of Ringer's (8.6 g/L sodium chloride, 0.33 g/L calcium chloride, 0.3 g/L potassium chloride) solution will be given following completion of the first 3-hour urine collection period: 0.5 liter infused over 10 min followed by 0.5 liter infused over 1 hour 50 minutes.
15826122|NCT04235062|Drug|Intravenous Bolus Furosemide|Following completion of the second 3-hour urine collection period and after the second set of blood and urine samples are obtained, 40 mg of furosemide will be given as an IV bolus.
15826123|NCT04235049|Drug|Glecaprevir/pibrentasvir|Treatment for HCV Infection
15826124|NCT04235036|Drug|Rituximab|Rituximab is given IV weekly x 4 weeks (to be started on study day 7 ± 3 days), then IV q3months x 4 doses (months 4, 7, 10, 13).
15826125|NCT04235036|Drug|Ibrutinib|Ibrutinib is given orally every day (28-day cycles) for a total of 12 cycles.
15826126|NCT04235023|Other|myeloid PTP1B expression analysis|peripheral blood macrophage PTP1B expression
15826127|NCT04235010|Device|Genius toothbrush|Patients brushed their teeth twice a day for 2 minutes. An integral timer was used in the genius toothbrush group.
15826128|NCT04235010|Device|Manual toothbrush|Patients brushed their teeth twice a day for 2 minutes. During brushing, patients in manual group assigned to use their brushes were provided with a digital timer.
15826129|NCT04234997|Drug|Suvorexant 20 mg|Participants will be advised to take the medication at 10PM for 7 days.Participants will be instructed to stop smoking by 10 pm the day before, in order to ensure they meet the breath CO criterion (CO ≤ 4 ppm) indicating overnight abstinence.
15826130|NCT04234997|Drug|Suvorexant 0mg|Participants will be advised to take the medication at 10PM for 7 days.Participants will be instructed to stop smoking by 10 pm the day before, in order to ensure they meet the breath CO criterion (CO ≤ 4 ppm) indicating overnight abstinence.
15826131|NCT04234971|Drug|Intervention group (DBM/BMP)|All patients will undergo a standard procedure for exposure of the cleft alveolar defect and closure of all oronasal fistulae. After induction of general anesthesia, the patient will be intubated with an oral ray tube and prepped and draped in sterile fashion. Pre-operative antibiotics will be given to cover oral flora (i.e. Unasyn or clindamycin if penicillin allergy exists). The intra-oral space will be exposed and the nasal floor and palatal mucosa will be primarily closed to create a water-tight space for the graft. The integrity of the nasal floor mucosa will be tested using methylene blue dye. Following closure of the fistula, the alveolar bone graft will be performed. For the treatment group, 10cc of crushed DBM will be mixed with the micro-sized sponge of rh-BMP-2 (Infuse Bone Graft, Medronic, Minneapolis, MN). The sponge and DBM will then be packed into the defect to completely fill the bony space (FIGURE 3). The anterior mucosa will then be closed.
15826132|NCT04234971|Drug|Control group(autologous ICBG)|The patient will be induced with anesthesia, prepped, and draped. The intra-oral space will be exposed and the nasal floor and palatal mucosa will be primarily closed to create a water-tight space for the graft. The integrity of the nasal floor mucosa will be tested using methylene blue dye. Following closure of the fistula, the alveolar bone graft will be performed.In the control group, the ICBG will be harvested percutaneously using the Accumed bone graft harvesting system. Briefly, an incision will be made in iliac crest and drill bit inserted. Multiple passes of the drill be used to harvest as much autograft bone as possible from the cancellous region of the iliac crest.Following harvest, fibrin glue will be instilled for hemostasis and a Ropivicaine On-Q pain pump inserted for post-operative pain control. The harvest bone graft will be packed into the alveolar defect in a similar fashion and the mucosa closed anteriorly.
15826133|NCT04234958|Other|Osteopathic manipulative treatment|Specific protocol including 4 osteopathic techniques targeting the pericardium
15826134|NCT04234958|Other|Sham therapy|Sham therapy mimicking the osteopathic techniques applied to experimental group
15826135|NCT04234945|Drug|Doxycycline Capsule|Group A will be the study group and will be given oral Doxycycline capsule 100mg bd for 3/7. She will be instructed to commence the medication on day 7 of her next menstrual cycle and hysterosalpingogram will be done within the proliferative phase (Day 10) of the same menstrual cycle after cessation of bleeding.
15826136|NCT04234945|Drug|Multivitamins W/Iron Tab|Group B will be the study group and will be given oral Multivitamin capsule i bd for 3/7. She will be instructed to commence the medication on day 7 of her next menstrual cycle and hysterosalpingogram will be done within the proliferative phase (Day 10) of the same menstrual cycle after cessation of bleeding
15826137|NCT04234932|Drug|Netarsudil Ophthalmic|Topical instillation of commercial preparations of netarsudil 0.02% ophthalmic solution (Rhopressa and Roclatan)
15826138|NCT04234906|Drug|Dexmedetomidine|Dexmedetomidine: 1 mcg/kg administered over 20 min peri-intubation period, followed by a 0.5 mcg/kg/h infusion for 72 h postoperatively or ready for extubation prior to 72 hour time period
15826139|NCT04234906|Drug|Magnesium Sulfate|Magnesium Sulfate (50 mg/kg) bolus administered at the time of Aortic Cross Clamp Release, with continued administration for 72 hours postoperatively at a dose of 30 mg/kg/day
15826140|NCT04234906|Drug|Amiodarone|I V Amiodarone 2.5 mg/kg administered over 30 minutes Second 2.5 mg/kg dose if needed over 30 minutes Continuous Intravenous Infusion 10-15 mg/kg/24 hours
15826141|NCT04234906|Drug|Procainamide|IV Procainamide 10-15 mg/kg administered over 45 minutes Continuous Intravenous Infusion 20-50 mcg/kg/min
15826142|NCT04234867|Drug|Dapagliflozin|once daily for 5 days
15826147|NCT04234841|Diagnostic Test|Blood test|Blood test
15826148|NCT04234815|Behavioral|CETA Short Session (CSS)|CETA Short Session (CSS) is a brief, low-intensity psychosocial intervention incorporating foundational components of the Common Elements Treatment Approach (CETA). CETA is an 8-12 session, transdiagnostic psychotherapy for common mental disorders. CSS was designed to serve as both a prevention/support approach for a broader range of needs, as well as an engagement/outreach strategy to identify and refer individuals to treatment. CSS is delivered in a group format over approximately two hours and consists of: 1) Psychoeducation: instruction about the brain and brain functioning, including normalization of psychological responses to stress and a brief self-assessment; 2) Safety: screening and referral for individuals identified as at risk of harm to self or others; and 3) Cognitive coping: based on the cognitive triangle, participants practice identifying an unhelpful thought changing it to a more helpful alternative, and examining how these thoughts impact feelings and behaviors.
15826149|NCT04234815|Behavioral|Psychoeducation and Safety|This intervention is the same as CSS with the exception that the cognitive coping skill training is removed.
15826150|NCT04234802|Other|Heat Education and Awareness Tools|HEAT training will be delivered to agricultural workers by research staff in this study in the spring. HEAT training uses interactive approaches to engage participants and posters with visuals. Training covers types of heat-related illness and treatments, risk factors, appropriate clothing and hydration, and keeping cool in the home and community. The HEAT awareness application was developed in collaboration with Washington State University's AgWeatherNet Program to notify supervisors signed up for the service about hot weather conditions that might increase the risk for adverse health effects for workers. The HEAT awareness application is designed to allow subscribers to select weather stations of interest and view current heat indices as well as maximum daily heat indices forecasted over the following week. This information is coupled with information about health effects and prevention of adverse heat health effects. Materials are provided in English and Spanish.
15826151|NCT04234789|Diagnostic Test|cardiopulmonary exercise testing with dynamic hyperinflation maneuver|test performed as recommended by ATS guidelines
15826152|NCT04234789|Diagnostic Test|spirometry|test performed as recommended by ATS guidelines
15826153|NCT04234789|Diagnostic Test|pletysmography|test performed as recommended by ATS guidelines
15826154|NCT04234789|Diagnostic Test|forced oscillometry technique|test performed as recommended by ATS guidelines
15826155|NCT04234776|Drug|Ketamine|(0,75 mg/kg) saline solution (15 mg) Escitalopram (5 mg) Aripiprazole
15826156|NCT04234776|Diagnostic Test|Cognition|Composite tools
15826157|NCT04234776|Other|Suicide risk|MADRS (10) and HAM-D (3)
15826158|NCT04234776|Other|Depression thoughts|EPD
15826159|NCT04234776|Other|Quality of life and disability|Quality of life and disability
15826160|NCT04234776|Other|Clinical and epidemiological factors|Variables and categories
15826161|NCT04234776|Device|Safety of ketamine IM|Vital signs
15826162|NCT04234776|Other|Tolerability of ketamine IM|UKU-SERS, YOUNG, CADSS and BPRS-12.
15826163|NCT04234763|Behavioral|Strategies to lower postprandial hyperglycemia in T2D patients|T2D patients will undergo a 14-day chronic feeding trial intervention where the strategies to lower postprandial hyperglycemia will be educated. For example, to control portion of carbohydrate, incorporate low GI food and diabetes-specific formula, promote physical activity and practice consistent meal timing. After that, patients will undergo MCT again to evaluate the difference before and after the intervention.
15826164|NCT04234763|Behavioral|Control group|Assess nutritional status and no active intervention is conducted.
15826165|NCT04234750|Biological|mesenchymal stem cell conditioned medium-derived pleiotropic factor|After the patient is enrolled, when the patient's condition is stable, he is ready to undergo skin transplantation. For the donor site, an electric dermatome was used to remove the skin. The two donor areas of the same patient were divided into a pleiotropic factor group and a blank group randomly. After placing a coarse mesh vaseline oil gauze, then cover a certain thickness of sterile gauze and pressure bandage.
15826166|NCT04234737|Behavioral|Hypnotherapy|Hypnotherapy
15826167|NCT04234724|Other|Kinetics test, oral fat tolerance test, and an oral glucose tolerance test.|Subjects will participate in a kinetics test, oral fat tolerance test, and an oral glucose tolerance test.
15826168|NCT04234711|Procedure|Surgical strategy|To compare the efficacy between conventional repair and sutureless technique for total anomalous pulmonary venous connection
15826169|NCT04234685|Device|High Intensity Physio Light Therapy (HIPL Therapy™)|HIPL Therapy™ is an advanced phototherapy method that utilizes an emission wavelength spectrum that has been optimized for treatment of musculoskeletal disorders (MSD) such as OA.
15826170|NCT04234685|Behavioral|Education|Participants will take part in education on osteoarthritis, pain neurophysiology, and self-management strategies with the treating physiotherapist. The education will take place during the lab visits and will be brief (5-10 minutes at each session).
15826171|NCT04234685|Behavioral|Aerobic Exercise|Participants will develop an individualized walking program. The goal will be to walk 30 minutes 5 times/week if able. For all participants who are unable to achieve this walking, they will be provided with a progressive walking program that starts at their baseline (the distance they can walk without being sore an hour later; and without feeling like they will be unable to perform their usual activities of daily living because of the walk). They will be encouraged to then progress by 10-20% each week. Participants will be asked to use a provided walking log to keep track of their progress.
15826172|NCT04234685|Behavioral|Resistance Exercise|Participants will also be instructed how to perform a series of six exercises: squat, step-up, lunge, single leg stance, knee flexion/extension, and resisted hamstring curl. The exercise technique and dosage will be tailored to the individual's current abilities. For example, if someone is unable to squat down to the level of a chair and return to standing, the chair height will be raised until the participant is able to perform the activity. The participants will begin by being asked to complete one set of 8-12 repetitions of each exercise, once daily, then progress to two or three sets daily as able. They will perform the exercises twice/week in the lab where they will receive support for problem solving and progression. Participants will be asked to use a provided exercise log to keep track of their progress.
15826173|NCT04234685|Device|Placebo Physio Light Therapy (HIPL Therapy™)|Phototherapy delivered at an intensity of 5 mW/cm2, a dosage at which there is no therapeutic benefit expected, but the light will still be visible to the participant.
15826174|NCT04234672|Drug|TAK-831 Oral Tablet|TAK-831 tablet.
15826175|NCT04234672|Drug|[14C]TAK-831 IV Infusion|[14C]TAK-831 IV infusion.
15826176|NCT04234672|Drug|[14C]TAK-831 Oral Suspension|[14C]TAK-831 oral suspension.
15826177|NCT04234659|Device|Clinical placement of a temporary IMPELLA® mechanical circulatory support device.|Surgical placement of the IMPELLA® device for life threatening cardiogenic shock not responsive to other medical treatment.
15826178|NCT04234646|Behavioral|Patient Navigation (PN) 2.0 Checklist|The PN 2.0 Checklist intervention is centered on a learning health system checklist that enumerates a patient's Social Determinants of Health (SDoH) related barriers and tracks completion of services to address SDoH (at community oncology and community social service settings) as well as completion of USPSTF recommended cancer-related screenings, behavioral counseling, and immunizations.
15826179|NCT04234646|Behavioral|One-on-one Patient Navigation (PN)|The one-on-one Patient Navigation will be based on a Case Management Model where PNs perform appointment scheduling and reminders; facilitate communication between patients and care teams; and identify and reduce patient barriers through education, outreach, and referrals to community, local, and state resources
15826180|NCT04234620|Drug|Toripalimab injection|240 mg/6 mL/vial. The recommended dose of Toripalima is 3 mg/kg, intravenous infusion every 2 weeks until disease progression or intolerable toxicity.
15826181|NCT04234607|Drug|TQB2450|TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
15826182|NCT04234607|Drug|Anlotinib|a multi-target receptor tyrosine kinase inhibitor
15826183|NCT04234607|Drug|Etoposide|Etoposide is a cell cycle-specific antitumor drug
15826184|NCT04234607|Drug|Carboplatin|Carboplatin is cell cycle nonspecific antitumor drug
15826185|NCT04234607|Drug|TQB2450（blank）|Subjects administrated TQB2450 (blank) intravenously (IV) on Day 1 of each 21-day
15826186|NCT04234607|Drug|Anlotinib（blank)|Subjects administrated anlotinib (blank) in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21)
15826187|NCT04234594|Drug|QL1203|6 mg/kg intravenous (IV) infusion only once，on the first day.
15826188|NCT04234594|Drug|Vectibix®|6 mg/kg intravenous (IV) infusion only once，on the first day.
15826189|NCT04234581|Dietary Supplement|Lysulin|Participants will be randomly allocated for 3 months to LysulinTM (1,110 mg TID, i.e. 3.3 g/day) or matching placebo.
15826190|NCT04234568|Drug|Lutetium Lu 177 Dotatate|Given IV
15826191|NCT04234568|Drug|Triapine|Given PO
15826192|NCT04234555|Diagnostic Test|Corticomotor excitability to the pelvic floor muscles|Transcranial magenetic stimulation will be used to probe the excitability of cortical projections to the pelvic floor muscles. The outcomes of interest will include motor evoked potential amplitude and silent period.
15826193|NCT04234555|Diagnostic Test|Pelvic floor muscle response to pressure applied at the vulvar vestibule|Electromyography will be used to determine whether the pelvic floor muscles (PFMs) respond to pressure applied to the vulvar vestibule as anticipatory (i.e. PFMs are active before the pressure is applied) and as behavioural (i.e. PFMs are active after the pressure is applied) responses. The amplitude of the EMG responses will also be recorded.
15826194|NCT04234555|Diagnostic Test|Pressure pain threshold (PPS)|A custom vulvalgesiometer will be used to determine the mean pressure at which participants first report pain at the posterior vaginal fourchette.
15826195|NCT04234555|Diagnostic Test|Temporal summation of pain|A custom vulvalgesiometer will be used to apply the same pressure (rated as 4/10 duiring PPS testing as described above) to the vulvar vestibule across 10 repetitions. The difference in pain rated on the tenth application and that rated on the first application will be the outcome.
15826196|NCT04234555|Diagnostic Test|Tonic, phasic and reflex activation of the pelvic floor muscles (PFMs)|Electromyography will be used to measure the mean smoothed, rectified activation amplitude across 1 second of complete rest, across three maximal effort PFM contractions, and across three attempts at a bearing down maneuver.
15826197|NCT04234542|Other|Low Level Laser Therapy|Each stage will follow this sequence of applications: (1) spine application (DUO-240 red and infrared array in a horizontal placement and 2 oblique placements bilaterally + LDR-100 laser probe + LDI-200 laser probe), (2) perineum application (DUO-240 red and infrared array in the surface of the perineum + LDR-100 probe) and (3) overlying branches of the pudendal nerve at the lateral perineum (LDI-200 probe). Parameters of frequency and duty cycle will be increased along with intensity as the stages progress.
15826198|NCT04234542|Other|Sham Low Level Laser Therapy|Each stage will follow this sequence of applications: (1) spine application (DUO-240 red and infrared array in a horizontal placement and 2 oblique placements bilaterally + LDR-100 laser probe + LDI-200 laser probe), (2) perineum application (DUO-240 red and infrared array in the surface of the perineum + LDR-100 probe) and (3) overlying branches of the pudendal nerve at the lateral perineum (LDI-200 probe). Parameters of frequency and duty cycle will be progressed, but power will always be set to 1%..
15826199|NCT04234529|Dietary Supplement|AMATEA™|"AMATEA™ is a patented dietary supplement consisting of a unique blend of caffeine and polyphenol antioxidants; standardized at 20% caffeine, 30% chlorogenic acids (similar to green coffee).
~Total of 1.35g of AMATEA containing 270mg of caffeine."
15826200|NCT04234529|Dietary Supplement|Caffeine|1.08g of microcellulose and 270mg of caffeine.
15826201|NCT04234529|Other|Placebo|1.35g of microcellulose
15826202|NCT04234516|Drug|Buprenorphine/Naloxone 8/2 milligram (mg) Sublingual Film|3 x 8 mg sublingual buprenorphine/naloxone films wrapped inside one Listerine strip at 8 pm daily + oral placebo pills q.i.d.
15826203|NCT04234516|Drug|Morphine Sulfate 30 mg|oral morphine sulphate 30 mg immediate release tablets q.i.d. + two sublingual Listerine strips at 8 pm
15826228|NCT04234308|Drug|Catgut|Periodontal and periimplant flaps closed with at least one suture with Chromic Gut Absorbable suture, natural, 4-0. (TAGUM®)
15826229|NCT04234308|Drug|Polytetrafluoroethylene|Periodontal and periimplant flaps closed with at least one suture with expanded Polytetrafluoroethylene Non absorbable suture, synthetic, 4-0. (TAGUM®)
15827218|NCT04226495|Drug|Sufentanil Bolus|Intra-operative sufentanil bolus
15826204|NCT04234503|Behavioral|Ethics Quarter|"In the intervention, nurse managers have two educational packages per week, one taking 15 minutes (one quarter).The structure of the whole intervention is made according to the dimensions of ethical activity profile of nurse managers (Laukkanen et al. a2016; Laukkanen et al b2016) consisting of managers:
~Developing of own ethics knowledge,
~Influencing ethical issues,
~Conducting/implementing ethics research,
~Identifying and
~Solving ethical problems.
~Intervention includes also orientation and summary, in total 12 educational packages.
~After every dimension, NMs have to make self-reflection and development plans, in total five times. This provides them the opportunity to link their everyday experience with ethical theory."
15826205|NCT04234490|Procedure|Parenteral nutrition|Impact of parenteral nutrition on patient quality of life over time and impact on carer burden
15826206|NCT04234477|Drug|Beta-blocker strategy|Clinicians within the intervention groups will be free to use whatever dosing amount and frequency of their assigned medication class that they deem as medically appropriate, including the decision to use intermittent IV boluses versus continuous infusions.
15826207|NCT04234477|Drug|Calcium channel blocker strategy|Clinicians within the intervention groups will be free to use whatever dosing amount and frequency of their assigned medication class that they deem as medically appropriate, including the decision to use intermittent IV boluses versus continuous infusions.
15826208|NCT04234477|Drug|Physician preference strategy|"This strategy allows for usual care, with providers selecting their preferred rate-control agent. IV beta-blockers available through the inpatient pharmacy include metoprolol or esmolol, and IV calcium channel blockers include diltiazem and verapamil."
15826209|NCT04234464|Combination Product|Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg|Budesonide/albuterol sulfate combination inhalation aerosol single dose
15826210|NCT04234464|Combination Product|Placebo metered-dose inhaler|Placebo inhalation aerosol single dose
15826211|NCT04234451|Procedure|SPA acupuncture|"For patients in the AA group, acupuncture was performed at a selected point in the SPG by inserting the needle from the lower border of the zygomatic arch, posterior to the suture protuberance between the zygomatic process and temporal process. The needle was directed obliquely anteriorly, until nearly the whole needle was beneath the skin, and then rotated until the patient felt de-qi sensations . The patients in the AA group received four courses of active acupuncture(visit 1,2,3 and 4), twice a week during weeks 1 and 2, and then followed-up for a further 2 weeks (visit 5 during week 3 and visit 6 during week 4)."
15826212|NCT04234451|Procedure|sham acupuncture|For patients in the SA group, the needle was inserted at the same acupuncture point as for patients in the AA group, but to a depth of only 2-3cm and the procedure of rotating, twirling and thrusting the needle was repeated. During the acupuncture process, the acupuncturist sat on the side of the participant, where the patient could neither see the acupuncturist's face nor the length of the needle. The patients in the SA group received four courses of active acupuncture(visit 1,2,3 and 4), twice a week during weeks 1 and 2, and then followed-up for a further 2 weeks (visit 5 during week 3 and visit 6 during week 4).
15826213|NCT04234438|Device|SL-MPL treatment protocol was performed with a 577 nm yellow laser (EasyRet, Quantel Medical, Cedex, France)|Macular laser treatment was applied after pupil dilation and topical anesthesia. Laser application was performed with a Mainster Standard contact laser lens (Volk Optical, Mentor, OH, USA). To determine the appropriate personalized calibration value, single-spot test shot was applied under the green filter to a non-edematous area of the macula outside the temporal vascular arcade. The laser power was gradually increased until it formed a barely visible laser spot. The power of the micropulse pattern laser was set at 50% of the power needed to form a barely visible laser spot. Laser parameters used were 200 ms duration, 160 µm spot diameter, low operating cycle (5%), and zero spacing with 5x5 pattern shape. SL-MPL was applied to the areas where edema was detected in OCT and examination.
15826214|NCT04234425|Behavioral|Trauma-Informed Yoga|Trauma-Informed Yoga practice held within a high school weight training class
15826215|NCT04234412|Procedure|umbilical cord blood stem cell implantation for osteoarthritis treatment|"The arthroscopic procedure is performed in the supine position after spinal anesthesia. Once the chondral lesion is identified through a standard anteromedial and lateral portal, meniscectomy, meniscal repair, and lateral retinacular release are performed if necessary. microfracture is performed using a microfracture awl.
~Once both the unstable cartilage and subchondral bone are removed in the lesion area and the sclerotic bone is peeled slightly by using a burr, hole(s) are created for implantation by using a drill bit(diameter 4; depth: 4mm). After implantation is performed in the hole by injecting the mixture of sodium hyaluronate and hUCB-MSCs, it is trimmed to the height of the surrounding articular surface."
15826216|NCT04234399|Diagnostic Test|Fluciclovine PET/CT using a digital PET/CT|Fluciclovine is a radiotracer that will be used in conjunction with the high resolution digital Vereos PET/CT scanner.
15826217|NCT04234386|Radiation|GammaPod Radiation|The basic design is a dose-escalation phase Ib study with 4 predefined dose levels. With this study treatment, participants will receive the dose level assigned treatment of radiation therapy before the lumpectomy surgery.
15826218|NCT04234373|Other|Low Carb diet|Low Carb diet (max. 130g carbohydrates/d) for 6 months
15826221|NCT04234347|Procedure|Intravenous access method|Comparing long and short axis approach to USGPIV access.
15826222|NCT04234334|Other|Consume 2 eggs with spinach per day|Participants will be randomly allocated to consume either 2 eggs or 2 egg substitutes with spinach daily for 4 weeks and after a 3-week wash out, they will be allocated to the alternate treatment
15826223|NCT04234334|Other|Egg Subsitute with spinach per day|Egg Subsitute with spinach per day
15826224|NCT04234321|Drug|basic fibroblast growth factor|Basic fibroblast growth factor,100ml/ bottle, (35000IU / 8ml) / 100cm2 / time,three times a day.
15826225|NCT04234321|Drug|Kangfuxin Liquid|Kangfuxin Liquid,20ml / 100cm2 / time,three times a day.
15826226|NCT04234321|Drug|0.9% Normal saline|0.9% Normal saline,20ml / 100cm2 / time,three times a day.
15826227|NCT04234308|Drug|Polyglycolic Acid|Periodontal and periimplant flaps closed with at least one suture with Polyglycolic Acid Absorbable suture, synthetic, 4-0. (TAGUM®).
15826230|NCT04234308|Drug|Polyamide|Periodontal and periimplant flaps closed with at least one suture with Nylon Non absorbable sutures, synthetic, 4-0. (TAGUM®)
15826231|NCT04234295|Procedure|Fat Tissue Biopsy|If subjects are scheduled for a surgical procedure a fat sample will be collected during the beginning of the surgery. If subjects are not scheduled for a surgical procedure, a small sample of subcutaneous (superficial) fat tissue from subjects abdomen area will be collected.
15826232|NCT04234282|Procedure|Manual Physical Therapy|Orthopedic manual physical therapy targeting the knee joint and soft tissues with complementary exercises targeted at their impairment.
15826233|NCT04234269|Other|Assessment|Evaluation forms will be applied to the patients who meet the inclusion criteria by face to face interview method.The sociodemographic information of the patients and the time taken to answer the questions in the questionnaires will vary according to each patient, but will take approximately 45 minutes. The second interview will be conducted with the patients for test-retest application at 1 week intervals.
15826234|NCT04234256|Other|Static stretching exercise|Standing quadriceps stretch, Gastrocnemius stretch, Standing split, Adductor stretch, Half kneeling groin stretch, Hamstring stretch on the bench, Prayer squat, Seated adductor and hamstring stretch, Hurdle seat, Seated glute stretch, Lying glute stretch, Seated groin abduction, Soleus stretch, Half kneeling quad stretch, Split hamstring stretch
15826235|NCT04234256|Other|Dynamic stretching exercise|Downward dog to runner's lunge, Dynamic squat stretch, Crescent to hamstring stretch, Half kneeling hamstring stretch, Side to side lunge with reach, Standing calf and hamstring stretch, Hurdles, Side to side lunge with step, IT band stretch, Walking quad stretch, Swing the leg forward and back, Swing the leg cross, Knee pull, Standing quat stretch, Standing gluteus stretch
15826236|NCT04234243|Procedure|cytoreduction and HIPEC|cytoreduction CCR 0-1, and HIPEC close technique
15826237|NCT04234230|Other|Prevalence Survey|Questionnaire survey on self-management
15826238|NCT04234217|Device|Continuous positive airway pressure|Continuous positive airway pressure (CPAP) treatment of obstructive sleep apnea (OSA)
15826239|NCT04234217|Other|Niacin|Suppression of lipolysis by niacin infusion
15826240|NCT04234204|Drug|Fezolinetant|Oral
15826241|NCT04234204|Drug|Placebo|Oral
15826242|NCT04234191|Drug|Buprenorphine/naloxone|Buprenorphine/naloxone is an opioid agonist treatment for opioid use disorder. It is administered orally via sublingual tablet form.
15826243|NCT04234191|Drug|Hydromorphone|Hydromorphone is an opioid used for managing pain, craving, and withdrawal. It is administered orally via tablet or liquid form; or administered intravenously, subcutaneously, or intramuscularly via liquid form.
15826244|NCT04234178|Drug|Epidural|2 µg/ml fentanyl + %0,125 bupivacaine (20 ml) to epidural
15826245|NCT04234178|Drug|Intrathecal+Epidural|10 µg fentanyl + 2 mg bupivacaine to intrathecal 7.4 ml saline volume to epidural
15826246|NCT04234165|Device|TURBT|different power sources ( bipolar vs monopolar)
15826247|NCT04234152|Other|Photo-protection|The MV solution is delivered from producing companies in amber vials. The MV will be sampled by the pharmacy technician in a syringe that is photo-protected with a white label indicating the subject study name, protocol number and the infusion rate. The MV will be transported to the unit in the same photo-protected syringe. In the neonatal unit, this syringe will be installed in the pump and connected to photo-protected extension duration.
15826248|NCT04234152|Other|Standard Care|This group will receive the standard practice of PN compounding in the pharmacy followed by infusion in standard infusion kit available in Sainte-Justine's Hospital.
15826249|NCT04234139|Procedure|liver transplant|solid organ transplant
15826250|NCT04234126|Procedure|ERCP|Routine ERCP for CBD stone with the gallbladder in situ, the chronic gallbladder status was defined as gallbladder wall thickness≥4mm, chronic cholecystitis, polyps,crudely or calculus .
15826251|NCT04234113|Drug|SO-C101|SO-C101
15826252|NCT04234113|Drug|pembrolizumab|pembrolizumab
15826253|NCT04234100|Other|Orange juice rich in hesperidin and narirutin|The product is a concentrated orange juice provided by the CITRUS Department of Florida (USA: www.FloridaCitrus.org).
15826254|NCT04234087|Other|Additional balance and resistance training|Additional exercise program with balance and resistance training three times per week. After completion participants are encouraged to continue exercise training at home according to recommendations and will receive control calls every two weeks.
15826255|NCT04234074|Device|Volusense paediatric monitoring device|Comparison of Volusense paediatric monitoring device to full cardiorespiratory polysomnography.
15826257|NCT04234048|Drug|Fenretinide|"Accelerated Phase 1a 100% Dose escalation in 8 single-patient cohorts
~Standard Phase 1a 40% Dose escalation in 3-patient cohorts X 3 cohorts
~Phase 1b Dosed at MTD in 20 patients as disease-specific expanded cohort"
15826258|NCT04234035|Behavioral|Decision Aid|Decision aid to facilitated shared decision-making
15826259|NCT04234035|Other|Standardized Educational Material (informational pamphlet)|Pamphlet with information about kidney stones
15826260|NCT04234022|Drug|Zn-DDC|Zn-DDC added to myeloma samples for culturing
15826261|NCT04234022|Drug|Lanalidomide with Zn-DDC|Lanalidomide with Zn-DDC added to myeloma samples for culturing
15826262|NCT04234022|Drug|Pomalidomide with Zn-DDC|Lanalidomide with Zn-DDC added to myeloma samples for culturing
15826263|NCT04234009|Other|Healthy Lifestyle|"The physical activity guidelines for older consist of 150 minutes per week moderate-to-high intensity exercise, two times per week muscle and bone strengthening exercises, which are combined with balance exercises. Additional health benefits can be achieved with a longer exercise duration, frequency and/or intensity. Furthermore, the amount of time sitting should be minimised. The dietary guidelines are described in detail in the so-called The Wheel of Five. In brief, the circle is divided into four food groups and one beverage group. More than half of the circle is covered by fruits, vegetables, whole grain (containing) breads, cereals and potatoes. A much smaller part is compromised by animal source foods, spreads and cooking fats. Water, tea and coffee without sugar complete the circle."
15826264|NCT04233996|Drug|Piperacillin-Tazobactam 4 g-0.5 g|Patients with FN who empirical treatment with piperacillin-tazobactam 4g/6h
15826265|NCT04233996|Drug|Cefepime 2000 mg|Patients with FN who required empirical treatment with cefepime 2g/8h
15826266|NCT04233996|Drug|Meropenem 1000 mg|Patients with FN who required empirical treatment with meropenem 1g/8h
15826267|NCT04233983|Procedure|Laparoscopic Endometriosis Surgery|Patient with ERROR(endometrioma related reduction in ovarian reserve), and endometrioma larger than 3 cm diameter will be operated after IVF&ICSI procedure. Operation will be done by senior surgeons of our department. Laparoscopic endometrioma operation procedure consists of excision of endometrioma cyst with its capsule from ovary without using any electric modality to prevent ovarian damage.
15826268|NCT04233970|Behavioral|web-based intervention programme|"The intervention will be designed as an individualized, dialogue-based system that will provide PwMS coordinated, individually tailored information based on the software platform broca®. The intervention programme will consist of three sections:
~EBPI/decision aid (five modules plus decision aid in case of an acute relapse) provided by the broca® programme. The key element of the EBPI/decision aid is the information on glucocorticosteroids for the treatment of acute relapses.
~A webinar led via WebEx by a trained MS nurse with questioning/chat session (approx. 60-75min).
~A supervised chat room provided via the DMSG (https://www.dmsg.de/ms-connect). In addition, email reminders will be used to enhance involvement of participants."
15826269|NCT04233970|Behavioral|web-based information material offered via the same platform (broca®) in addition to usual care|Participants in the control group will have access to web-based information material offered via the same platform (broca®) in addition to usual care. The control group intervention will be based on material of the German Multiple Sclerosis Society (DMSG) on relapse management. The programme will accompany the participants over a period of 4 weeks and a reminder system with neutral e-mail reminders will be used to promote the use of the programme.
15826270|NCT04233957|Dietary Supplement|High Sodium|10 days of 3900 mg of sodium/day in excess of normal dietary intake delivered via enteric capsules filled with table salt.
15826271|NCT04233957|Other|Placebo|10 days of enteric capsules filled with dextrose.
15826272|NCT04233931|Behavioral|PrEP medication adherence mobile app|Participants use a PrEP medication adherence mobile app for six weeks.
15826273|NCT04233918|Drug|Evinacumab|Part A: Single IV dose Part B & C: IV dose Q4W
15826274|NCT04233905|Behavioral|Psychometric questionnaire study|Four groups participate in the psychometric questionnaire study. A group of mute children and their mothers (EG:A), as well as a normal, healthy control group (KG:A) with roughly the same age and sex characteristics fill out one-time questionnaires about current daily life experiences. In addition, another group of formerly mute adults (EG:B) as well as a comparable age/sex normal control group will be retrospectively questioned using the same specifically tailored questionnaire.
15826275|NCT04233892|Drug|CBD-bFGF|CBD-bFGF will be injected into the endometrium after hysteroscopy under the guidance of ultrasound
15826276|NCT04233892|Drug|Collagen/BMMNCs|A collagen scaffold loaded with BMMNCs will be transplanted into the uterine cavity after hysteroscopy under the guidance of ultrasound
15826277|NCT04233892|Drug|Estrogen|Patients will receive regular estrogen therapy
15826282|NCT04233866|Drug|Fluorouracil|Given IV
15826283|NCT04233866|Drug|Gemcitabine|Given IV
15826284|NCT04233866|Drug|Gemcitabine Hydrochloride|Given IV
15826285|NCT04233866|Drug|Leucovorin|Given IV
15826286|NCT04233866|Drug|Leucovorin Calcium|Given IV
15826287|NCT04233866|Drug|Liposomal Irinotecan|Given IV
15826288|NCT04233866|Drug|Nab-paclitaxel|Given IV
15826289|NCT04233866|Other|Quality-of-Life Assessment|Ancillary studies
15826290|NCT04233866|Other|Questionnaire Administration|Ancillary studies
15826291|NCT04233853|Behavioral|CoLiPri intervention|General practitioners and their screened patients have access to the consultation-liaison services for a total duration of 12 months, including standard screening, expert consultations, on demand patient referral for structured mental health diagnostics, psychoeducation and treatment planning, as well as brief psychotherapeutic intervention and triage.
15826292|NCT04233853|Other|Usual primary care enhanced|Usual primary care practice as offered in routine care. Enhanced means that practitioners receive a basic training which consists of guideline-based structured screening procedures for depression and anxiety mental disorders in primary care.
15826293|NCT04233840|Drug|P1101 (Ropeginterferon alfa-2b)|solution for injection in prefilled syringe, 500 µg/ mL , 450μg /time, subcutaneous injection every 2 weeks
15826294|NCT04233840|Drug|Nivolumab|"Phase I study will use 0.3, 0.75, 1.5, 3mg/kg, Q2W for 3 doses after 6 doses of P1101.
~Phase II study : Group I will use 3mg/kg, Q2W for 3 doses; Group III will use the dosage that determine from Phase I study 3 doses after 6 doses of P1101"
15826295|NCT04233814|Drug|Caveolin-1-Scaffolding-Protein-Derived Peptide (LTI-03)|LTI-03, a Caveolin-1 scaffold protein-derived 7-amino acid peptide to be administered as a dry powder by inhalation through a dry powder inhaler.
15826296|NCT04233814|Drug|Placebo|Matching placebo is micronized lactose powder administered by inhalation through a dry powder inhaler.
15826299|NCT04233788|Device|MR-scans using a 3T Prisma and a 7T Terra scanner (Siemens, Erlangen Germany)|The MR-scans performed at 3T and 7T are performed to evaluate whether high field MR-examinations bring an advantage to the patient in determining the IDH-status of the glioma. Two MRSI/CEST sequences will be tested against each other.
15826300|NCT04233749|Drug|Tranexamic acid tablets|325mg of tranexamic acid twice daily for six months
15826301|NCT04233736|Procedure|Bilateral lumbar erector spinae plane block|Bilateral lumbar erector spinae plane blocks performed under ultrasound guidance
15826302|NCT04233723|Other|peripheral blood samples|venous puncture
15826303|NCT04233710|Combination Product|Robot Rehabilitation + tDCS|Robotic therapy with Kinarm Exoskeleton Robot and 1 mA cathodal tDCS applied to contralesional M1 for 20 minutes.
15826304|NCT04233710|Behavioral|Robotic Rehabilitation + sham tDCS|Robotic therapy with Kinarm Exoskeleton Robot and sham tDCS.
15826336|NCT04233437|Drug|Transporter Cocktail|Digoxin 0.25 mg, furosemide 1 mg, metformin 10 mg, rosuvastatin 10 mg
15826361|NCT04233229|Device|t:slim X2 with Control-IQ|closed-loop from TANDEM diabetes care in patients at home for three months
15826305|NCT04233697|Drug|Copanlisib|Novel, pan-class phosphatidylinositol 3-kinase (PI3K) inhibitor with potent activity against both the δ and α isoforms9. Copanlisib has been evaluated for the treatment of a wide variety of malignancies, including lymphoma, either as a single agent or in combination with other investigational agents.
15826306|NCT04233697|Drug|Romidepsin|Indicated for treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy.
15826307|NCT04233684|Diagnostic Test|rapid urease test|"Rapid urease test is the test for H. pylori infection by detect the change of pH by urease enzyme metabolism.
~Pathologic test for H. pylori by H&E stain and Giemsa stain Gold standard is a immunohistochemistry."
15826308|NCT04233671|Behavioral|Mindfulness based relapse prevention and peer mentoring|"Importantly, the treatment will utilize a group format. Group process can serve as a vital agent in breaking down client denial about drug abuse problems. Groups have also been shown to be suitable for treating problems commonly associated with substance abuse, including depression, isolation, and shame.
~Additionally, groups intrinsically have many rewarding benefits, including reducing isolation and enabling members to witness the recovery of others. The eight-week group therapy intervention is co-led by a licensed counselor and a peer mentor for eight weeks, then followed by group sessions led by peer mentors for an additional four weeks."
15826309|NCT04233658|Drug|Placebo|3x2 capsules / day
15826310|NCT04233658|Drug|Cynara Scolymus|3x2 capsules / day
15826311|NCT04233645|Other|5-minute educational video|The 5-minute educational video depicts key components of entering data on the diary. Patients in this group will also have online access to the video when they are filling out their diaries.
15826312|NCT04233645|Other|Usual Care|The groups will be given a standard scripted verbal and identical written instructions as per usual care.
15826313|NCT04233632|Device|FC2 Condom|FC2: FC2 is composed of a synthetic nitrile rubber latex and 170mm in length. It has a flexible inner ring as the internal retention mechanism and a circular ring as the outer retention mechanism at the open end of the condom. It is pre-lubricated with silicone oil. It has a shelf-life of 5 years and is available in clear and other colors/scents. It is manufactured by Female Health Company, USA and has USFDA, World Health Organisation (WHO)/United Nations Populations Fund (UNFPA) and South African Bureau of Standards (SABS) approval
15826314|NCT04233632|Device|Cupid Condom|Cupid is composed of a Natural rubber latex and is 155mm in length. It has a Medical grade sponge as the internal retention mechanism and an octagonal outer frame as the outer retention mechanism. It is pre-lubricated with silicone oil. It has a shelf-life of 3 years and is available in clear and red color, vanilla scented variety. It is manufactured by Cupid Ltd, India and has WHO)/UNFPA, India Drug Control Authority, Conformitè Europëenne (CE) Mark of the European Union (EU) and SABS approval
15826315|NCT04233632|Device|Cupid 2 Condom|Cupid2 is composed of a Natural rubber latex and is 125mm in length. It has a Medical grade sponge as the internal retention mechanism and an octagonal outer frame as the outer retention mechanism. It is pre-lubricated with silicone oil. It has a shelf-life of 3 years and is available in Clear and purple color, vanilla scented variety. It is manufactured by Cupid Ltd, India and has WHO)/UNFPA, India Drug Control Authority, CE Mark of the EU and SABS approval
15826316|NCT04233619|Diagnostic Test|optical coherence tomography|non-invasive test performed by an Ophthalmologist that allows three-dimensional imaging of the retinal vasculature
15826317|NCT04233606|Other|Hypertonic Saline|Infusion of hypertonic saline to induce an osmotic secretion of the hormone vasopressin
15826318|NCT04233606|Other|Normal Saline|Infusion of normal saline to inhibit the secretion of the hormone vasopressin
15826319|NCT04233593|Biological|Lipopolysaccharide|Endotoxin E Coli
15826320|NCT04233580|Device|Amnio Excel + weekly|Amnio Excel + weekly
15826321|NCT04233580|Device|Amnio Excel + max every 2 weeks|Amnio Excel + max every 2 weeks
15826322|NCT04233567|Drug|Infigratinib|Given PO
15826323|NCT04233554|Behavioral|Patient Priorities Care|Patients will participate in a structured conversation in which the facilitator (i.e. social worker) helps patients identify their health goals, measurable, actionable, realistic outcomes (e.g. walk ½ mile daily). Both practice and patient level data will be collected.
15826324|NCT04233541|Diagnostic Test|Fall assessment|Through a comprehensive geriatric assessment carried out by our geriatrician led multidisciplinary team we gather information about fall recalls consistent with the definition of landing on the floor or ground.
15826325|NCT04233528|Diagnostic Test|Evaluation of systemic skin microvascular endothelial function|Laser-based method for evaluating non-invasive, operator-independent systemic microvascular function that detects microvascular flow in the skin for the evaluation of systemic vascular endothelial function.
15826326|NCT04233515|Drug|Oral anticoagulant|Clinical visit to a physician to assess stroke and bleeding risk and to possibly initiate OAC therapy or refer for left atrial appendage occlusion
15826327|NCT04233502|Drug|Melatonin|prolonged release 1 mg and 5 mg mini-tablets coated odorless and tasteless to facilitate swallowing
15826328|NCT04233502|Drug|Placebo|Placebo melatonin
15826329|NCT04233489|Behavioral|Family Nurture Intervention (FNI)|"FNI is a family based intervention that facilitates and strengthens the mother-infant emotional connection through a structured guided interaction by a physician.
~The mother is asked to sit with her baby in her arms so that they are face-to-face, and when the baby becomes restless, the physician will coach the mom to bring the baby back to a calm state. The mother will also be encouraged to verbalize her feelings to her baby. Mother-infant emotional connection is known to affect various developmental processes and improve overall health. FNI was previously shown to be efficacious in improving several long-term health outcomes in preterm infants in the neonatal intensive care unit (NICU)."
15826330|NCT04233476|Drug|99mTc-3PRGD2|Volunteers were injected intravenously and then scanned by SPECT/CT. Drugs use generic name：Technetium [99mTc] Hydrazinonicotinamide PEGylated Bicyclic RGD Peptide Injection dosage form:Injection dosage:0.3mCi/kg
15826331|NCT04233463|Dietary Supplement|Modulen|Crohn patients will be given Modulen, an oral polymeric diet enriched with TGF-beta 2, along with a tailored diet
15826332|NCT04233463|Drug|Budesonide|Standard treatment for mild Crohn Disease patients
15826333|NCT04233450|Other|BodyBabe questionnaire|assessment of young mothers' perceptions using self-questionnaires
15826334|NCT04233437|Drug|MLC1501|MLC1501 capsules (4 capcules (2000 mg) twice a day)
15826335|NCT04233437|Drug|CYP Cocktail|Repaglinide 0.25 mg, caffeine 100 mg, warfarin 10 mg (with vitamin K), omeprazole 40 mg, dextromethorphan 30 mg, midazolam 2 mg
15826337|NCT04233424|Drug|D-PLEX|D-PLEX is a new formulation of extended release of Doxycycline. Each 5g D-PLEX vial contains 54.6mg Doxycycline free base (1.09%), which is equivalent to 63mg Doxycycline hyclate (1.26%). D-PLEX is supplied as a sterile powder to be reconstituted to paste in the operating room, using standard aseptic techniques and is intended for single administration. The non-active components of the extended release antibiotic formulation are β Tri-Calcium polymer and a lipid matrix. All formulation components are biodegradable.
15826338|NCT04233424|Other|Standard of Care (SoC)|prophylactic, pre-operation per institution guidelines
15826339|NCT04233411|Other|Mycoprotein ingestion|
15826341|NCT04233385|Other|Myofascial Massage|The myofascial protocol outlines techniques, areas of the body, as well as time to be spent for each technique for a total of 25 minutes. The remaining 5 minutes of the massage are for the massage therapist to tailor myofascial massage to the needs and circumstances of each participant. In order to provide some level of customization, the therapist will determine the impact of massage on the participant's pre-existing pain and/or mobility limitations. Second, the therapist will assess the soft tissues around the affected breast, chest, and shoulder to determine the locations of pain, tissue firmness, and restricted mobility. Third, the therapist will use effleurage and petrissage techniques to gently massage the identified locations to soften and release the tissues. Techniques used will include deep friction of muscles, sustained compression, and fascial stretch.
15826342|NCT04233385|Other|Light Touch|Participants randomized to this group will receive 30 minutes of light touch to their affected breast, chest, and shoulder areas twice a week for 2 months. Therapists will follow a detailed light touch protocol for each of the 16 sessions. In addition, the therapist will inquire about the participant's response to the previous light touch treatment. Second, the therapist will assess the soft tissues around the affected breast, chest, and shoulder to determine the locations of pain, tissue firmness, and restricted mobility. Third, the therapist will place both hands on the participant for 3 minutes at each identified location. Pressure will be very light and consistent, with no side-to-side movement.
15826343|NCT04233372|Drug|Delstrigo|"Doravirine / lamivudine / tenofovir disoproxil fumarate (Delstrigo®) 100 mg doravirine, 300 mg lamivudine,300 mg tenofovir disoproxil fumarate equivalent to 245 mg de tenofovir disoproxil.
~1 covered tablet for day .( will be administered 28 days maximum)"
15826344|NCT04233359|Procedure|Local anesthetic thoracoscopy|Procedure to obtain histological biopsies of the parietal pleura on awake, fastening patients.
15826345|NCT04233359|Procedure|US-guided pleural biopsy|In local anesthesia, a closed needle biopsy is performed Ultrasound guided of the parietal pleura at the place of deepest fluid recess in the intrathoracic space. A pigtail catheter French 7-16 is placed afterwards for fluid drainage.
15826346|NCT04233346|Drug|Ponatinib|CP-CML patients will be randomized into 30 mg and 45 mg dose groups at the ratio of 1:1,each group taken orally once daily. Other patients taken 45mg orally once daily.
15826347|NCT04233333|Device|method of fixation of the orogastric tube|Methods of fixation of the orogastric tube will be randomized
15826348|NCT04233320|Device|silicone cream containing Allium Cepa extract|silicone cream containing Allium Cepa extract contains 10% of Allium cepa bulb extract.
15826349|NCT04233320|Device|Commercial scar gel|Commercial scar gel is a topical silicone gel. It contains cyclic and polymeric siloxanes and Vitamin C ester.
15826350|NCT04233307|Diagnostic Test|Telethermographic images|Infrared digital thermography photographs of fracture wound and contralateral limb before and after propofol infusion.
15826351|NCT04233294|Drug|Chidamide|Chidamide is a novel and orally active benzamide class of HDAC inhibitor that selectively inhibits activity of HDAC1, 2, 3 and 10, which can Induce tumor-cell apoptosis, suppress cell proliferation and enhance immune surveillance.
15826352|NCT04233294|Drug|Camrelizumab|Camrelizumab is a humanized anti-PD-1 monoclonal antibody.
15826353|NCT04233294|Drug|Decitabine|Decitabine is an investigational (experimental) drug that works by depleting DNA methyltransferase 1 (DNMT1), which can increase tumor antigens and HLA expression, enhances antigen processing, promotes T cell infiltration, and boosts effector T cell function.
15826354|NCT04233281|Other|Kori tofu|16.5 gram Kori-tofu mixed in a high carbohydrate test meal
15826355|NCT04233281|Other|Whey protein|high carbohydrate test meal with whey protein, matched in macronutrient content
15826357|NCT04233255|Device|Neuromuscular Ultrasound (US)|"Quantitative ultrasound measurements will be performed to studied muscles according to a standard protocol; for each muscle three consecutive measurements will be made to minimize variation in echo intensity during analysis .The captured images will be analyzed offline for echo intensity by means of computer-assisted grayscale histogram analysis.The study will be performed using My lab 7 ultrasound system (Esaote company, Italy) that is equipped by 7-19 MHz linear array transducer and color and power Doppler.
~Technique: evaluation of studied muscles for echo intensity (ECHO), quantitative assessments of echointensity, muscle perfusion, transverse and longitudinal sections of the muscle and its thickness at rest and during maximal voluntary contractions (MVC), overlying subcutaneous fat, cross-sectional area (CSA), and angled fibers of pennate muscles."
15826358|NCT04233255|Device|Electrophysiological studies|"Includes: Motor and sensory nerve conduction study, F-wave and H-reflex study to assess the proximal roots, Electromyography (EMG) of the studied muscles.
~using machine: recordings will be performed with a Nihon Kohden equipment (model 7102) with the following parameters: sweep time 8 ms/D, sensitivity 0.5 mV/D, low frequency filter 2 Hz, high frequency filter 10 kHz, stimulation duration 0.1 ms and stimulation frequency 1 Hz."
15826359|NCT04233255|Diagnostic Test|Seum CPK, CK-MM levels, Lactate dehydrogenase and alanine aminotransferase.|measured in U/L using ELISA.
15826360|NCT04233242|Other|Clinical management informed by HIV-1 genotypic resistance testing|"The study intervention will consist of the following components:
~Genotypic resistance testing (GRT);
~Review of GRT results by an expert committee providing a treatment recommendation;
~GRT-based decision on further therapy (switch or maintain current ART regimen; choice of regimen); and
~GRT-informed adherence support."
15826362|NCT04233229|Other|home healthcare services|home healthcare services from Air Liquide in patients at home for three months
15826363|NCT04233229|Other|usual care for daily insulin treatment|multiple daily injection insulin regimen with family nurse's daily assistance at home for performing insulin injections and/or glucose monitoring
15826369|NCT04233203|Drug|Insulin Faster Aspart|Currently receiving Faster Aspart during 3 or more months.
15826370|NCT04233203|Device|Insulin pump|Currently receiving CSII therapy during 6 or more months.
15826371|NCT04233190|Drug|Alenia® 12mcg + 400mcg / Alenia® 6mcg + 200mcg|one inhalation, twice daily
15826372|NCT04233164|Drug|SOLU-MEDROL|Methylprednisolone sodium succinate for injection, United States Pharmacopeia grade (USP), sold as SOLU-MEDROL sterile powder by Pfizer, Inc, is an antiinflammatory glucocorticoid that occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol, but is insoluble in chloroform and is very slightly soluble in acetone. The study agent solution will be administered as an IV infusion over 30 minutes, for a total single dose of 1 mg/kg or 250 mg of methylprednisolone.
15826373|NCT04233151|Drug|QL1203|6 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle, just prior to the administration of chemotherapy.
15826374|NCT04233151|Drug|Placebo|6 mg/kg intravenous (IV) infusion on Day 1 of each 14-day cycle, just prior to the administration of chemotherapy.
15826375|NCT04233151|Drug|mFOLFOX6 regimen|The mFOLFOX6 regimen is consist of oxaliplatin 85 mg/m^2 intravenous (IV) infusion on Day 1;leucovorin, 200 mg/m^2 on Days 1 and 5-fluorouracil 400 mg/m^2 IV bolus on day 1, then 1200 mg/m^2/dx2days(total 2400 mg/m^2 over 46-48 hours) IV continuous infusion. Each cycle was 14 days.
15826376|NCT04233138|Other|SUPPORT online platform for people with type 1 diabetes|"This bilingual (English, French) training platform is accessible with an internet connection. Participants' learning is individualized depending on the way they take their insulin (injection or pump) and the way they measure their blood sugar (finger prick or continuous glucose monitoring).
~The training program starts with mandatory module on hypoglycemia. Once completed, participants will unlock all level 1 modules from the 6 categories (medication, blood sugar monitoring, nutrition, physical activity, hypo- and hyperglycemia, health and other situations). There are 3 levels of complexity. The platform contains functionalities such as reminder emails, discussion forum, quizzes, videos, downloadable forms, etc.
~Questionnaires will be sent by email (baseline, 6 months and 12 months) to collect information on hypoglycemia fear and frequency, diabetes knowledge, health literacy and platform evaluation and to include questions that are not included in the registry."
15826377|NCT04233125|Procedure|Core Decompression|Core Decompression
15826378|NCT04233125|Procedure|PMMA augmentation|Polymethylmethacrylate (PMMA) augmentation
15826379|NCT04233112|Drug|Melatonin 5 mg|Capsules containing 5mg melatonin will be prepared by Delta Care RX™ Pharmacy. Participants will be asked to take them nightly for one year.
15826380|NCT04233112|Device|Osteogenic loading|Osteogenic loading device therapy includes the emulation of impact forces through kinetic chains of natural impact absorption with fixtures that have the ability to capture bone compression data. Participants will be asked to perform osteogenic loading once per week.
15826381|NCT04233112|Device|Mock for Osteogenic Loading|Mock osteogenic loading will occur using the osteogenic loading device therapy includes the emulation of impact forces through kinetic chains of natural impact absorption with fixtures that have the ability to capture bone compression data. Participants will be asked to perform mock osteogenic loading once per week.
15826382|NCT04233112|Drug|Placebo (plant fiber) for melatonin|Capsules containing plant fiber will be prepared by Delta Care RX™ Pharmacy. Participants will be asked to take them nightly for one year.
15826383|NCT04233099|Procedure|Raman analysis of saliva with data collection and analysis|Saliva collection and processing to all the enrolled subjects and consecutive Raman analysis of the biological fluid. Statistical processing of the collected data.
15826384|NCT04233086|Other|No intervention, observational only|No intervention, observational only
15826385|NCT04233073|Drug|andexanet alfa|Andexanet is a recombinant version of human FXa
15826386|NCT04233060|Drug|CS3005|CS3005 will be orally administrated twice daily (BID) until PD, unacceptable toxicity, withdrawal of informed consent, or until maximum treatment duration per protocol (2 years)
15826387|NCT04233047|Drug|Fostemsavir|Fostemsavir 600 mg extended release tablets, administered 600 mg twice daily, will be supplied for compassionate use for the identified individual patient.
15826392|NCT04233021|Drug|Osimertinib|Osimertinib 80 mg/d
15826393|NCT04233008|Device|Foley catheter length|see arm description
15826394|NCT04232995|Other|Balance Training|Balance enhancing exercises
15826395|NCT04232995|Other|General Exercises|General Exercises
15826396|NCT04232982|Procedure|Transscleral cyclphophotocoagulation using the Micropulse system ( IRIDEX IQ810 Laser systems, Mountain View, CA).|Treatment will be applied over the limbal area to treat the ciliary body. The treatment will be delivered with an energy of 2000mW, a cycle of 31,33% and an on/off time of 0,5ms and 1,1ms. It will be delivered around a 360° surface with avoidance of the 3 and 9 o'clock areas. The treatment will be delivered during 80 secondes in each hemisphere and will be repeated twice, for a total of 320 secondes.
15826397|NCT04232982|Procedure|G-Probe transscleral cyclphophotocoagulation (Iris Medical Instruments, Montain View, CA)|"Treatment will be applied over the limbal area to treat the ciliary body. Sixteen (16) shots in total, which is four (4) shorts per quadrants, will be transmitted with a power from 1750 to 2000mV (titrating according to an audible pop) for a length of 2,0 secondes per shots. Treatment will be delivered around a 360° surface and avoiding the 3 and 9 o'clock areas."
15826398|NCT04232969|Drug|Exenatide extended release 2mg (Bydureon)|Subcutaneous Injection
15826399|NCT04232943|Biological|IMOVAX Inactivated Poliomyelitis Vaccine (IPV)|"IMOVAX® Polio is a highly purified, inactivated poliovirus vaccine. Each 0.5 mL dose contains:
~Active Ingredients:
~Inactivated Poliomyelitis Vaccine:
~Type 1 (Mahoney) 40 D-antigen units*
~Type 2 (MEF1) 8 D-antigen units*
~Type 3 (Saukett) 32 D-antigen units* * or the equivalent antigen quantity, determined by suitable immunochemical method"
15826400|NCT04232943|Biological|dmLT (adjuvant)|LT(R192G/L211A), or dmLT, is a derivative of wild-type ETEC heat-labile enterotoxin that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules. The protein has been designated LT(R192G/L211A) and has been extensively evaluated in pre-clinical animal studies for its ability to induce anti-dmLT antibody responses, as well as adjuvant the immune responses for co-administered antigens.
15826401|NCT04232943|Biological|Bivalent oral polio vaccine (bOPV)|"Polio Sabin™ One and Three (oral) is a bivalent, live attenuated poliomyelitis virus vaccine of the Sabin strains Type 1 (LSc, 2ab) and Type 3 (Leon 12a, 1b), propagated in MRC5 human diploid cells.
~Each dose (0.1 mL) contains not less than 106.0 CCID50 of Type 1 and 105.8 CCID50 of Type 3. Magnesium chloride is used as a stabilizer. Polio Sabin™ One and Three (oral) contains trace amounts of neomycin sulphate and polymyxin B sulphate."
15826402|NCT04232930|Other|Music|Four types of music will be provided, including pop, classical, jazz or spa music which are prepared by the study team. They contain instrumental songs only without vocal.
15826403|NCT04232917|Drug|2LPAPI®|Treatment
15826404|NCT04232917|Drug|Placebo|Placebo
15826405|NCT04232904|Procedure|Transversus abdominous plane block (TAP Block)|TAP block which is a peripheral nerve block preferred to postoperative pain management.
15826406|NCT04232891|Diagnostic Test|liquid biopsy|detection of tumor DNA alteration in cf-DNA
15826407|NCT04232878|Drug|CVL-936|CVL-936
15826408|NCT04232878|Drug|Matching Placebo|Placebo matching CVL-936
15826409|NCT04232865|Device|Biop System|"Stage 1 - Training:
~Up to 320 women in whom a complete procedure with the Biop System will be performed. Biopsies will be taken solely based on colposcopy examination. Enrolled participants will include at least 80 participants Histopathology identified with a high-grade lesion and at least 80 participants Histopathology identified as normal or with a low-grade lesion.
~Stage 2 - Validation:
~Up to 330 HIV negative women in whom a complete procedure with the Biop System will be performed.
~Validation stage will also include up to 165 HIV positive participants. All participants will be enrolled in up to 3 sites in South Africa."
15826410|NCT04232852|Dietary Supplement|Probiotic mix|The probiotic mix will contain strains of Streptococcus thermophilus, Saccharomyces cerevisiae, Lactobacillus acidophilus, L. rhamnosus L. helveticus, L. gasseri, L. plantarum, Bifidobacterium bifidum, Enterococcus faecium at a daily dose of 7 × 1010 CFU in the form of a capsule.
15826411|NCT04232852|Dietary Supplement|Placebo|Patients in the placebo group will receive an identical capsule of maltodextrin.
15826412|NCT04232839|Drug|BI 894416 - Formulation A2|Tablet
15826413|NCT04232839|Drug|BI 894416 - Formulation C2|Tablet
15826414|NCT04232839|Drug|BI 894416 - Formulation D2|Capsule
15826415|NCT04232839|Drug|BI 894416 - Formulation F2|Capsule
15826416|NCT04232839|Drug|BI 894416 - Reference Formulation 1|Tablet
15826417|NCT04232826|Biological|single dose of CNCT19|"Dose A: 1.00 x 10^8 autologous CNCT19 transduced cells via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide
~Dose B: 2.00 x 10^8 autologous CNCT19 transduced cells via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide
~Dose C: 4.00 x 10^8 autologous CNCT19 transduced cells via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide"
15826418|NCT04232813|Drug|Estradiol 10 MCG Vaginal Tablet [VAGIFEM]|To insert the tablets the patient must use the applicator provided in the way explained in the prospectus.
15826419|NCT04232813|Drug|Promestriene Vaginal|To insert the cream the patient must use the applicator provided in the way explained in the prospectus.
15826420|NCT04232800|Drug|Riboflavin|The intervention will consist of 100mg riboflavin (vitamin B2) given in three time daily dosing.
15826421|NCT04232800|Other|Placebo|An inert, standard placebo in identical capsules to primary intervention.
15826422|NCT04232774|Device|The Neurotronic arterial ablation catheter|a sterile, single use catheter (device) for delivering chemical agent to achieve perivascular denervation.
15826424|NCT04232748|Drug|first line systemic treatment for colorectal cancer|systemic chemotherapy (capecitabine or fluorouracil, oxaliplatin or irinotecan, with or without biological agents including cetuximab, bevacizumab, or panitumumab.
15826425|NCT04232735|Other|Tool and training|"The Source tool aims to assist health care providers with giving evidence based information about treatment outcomes by providing visualizations of personalized predictions of treatment outcomes for different treatments of oesophageal and gastric cancer. These predictions result from recently designed and updated prediction models on the survival, toxicity, complications and health related quality of life of oesophageal and gastric cancer patients.
~The training aims to teach participants to inform patients about outcomes of treatment. The training is placed in the context of shared decision making (SDM), following the 4-step model by Stiggelbout et al., 2015.8 The training is provided in small groups (3-6 participants) by an experienced trainer and supported by professional actors. The training aims to address knowledge, attitude and skills."
15826426|NCT04232722|Drug|Arsenicals|As4 S4
15826427|NCT04232709|Other|Shared electronic patient record|MedChart allows access to a shared electronic patient record that contains selected information related to a patient's cancer treatment. If a patient contacts the after-hours telemedicine service, the oncology nurse will have access to this shared record
15826428|NCT04232696|Device|Neuspera Implantable Sacral Nerve Stimulation System|Stimulation of the Sacral Nerve.
15826429|NCT04232683|Drug|Tamsulosin 0.4Mg Capsule|Tamsulosin given preoperatively to detect if rates of urinary retention after female pelvic floor surgeries are decreased
15826430|NCT04232683|Drug|Placebo oral tablet|Placebo pill given preoperatively
15826431|NCT04232670|Procedure|EUS + SHAM|Endoscopic Ultrasound
15826466|NCT04232449|Drug|placebo tablets|5 daily- doses of placebo (2 tablets)
15826467|NCT04232436|Other|Survival at discharge|Survival at discharge
15826432|NCT04232670|Procedure|EUS + Pancreatic Endotherapy|Pancreatic endotherapy may include any or all of the following maneuvers: pancreatic endoscopic sphincterotomy, stricture dilation using a bougie or hydrostatic balloon catheter, pancreatic stone extraction with or without mechanical or electrohydraulic lithotripsy, extracorporeal shock wave lithotripsy, and stent placement.
15826433|NCT04232657|Drug|Romosozumab|39 subjects with chronic SCI will be studied with a 2:1 ratio of randomization of drug to placebo. Romosozumab (210mg SQ) will be administered once a month for 12 months. Participants will arrive at the JJPVAMC or KIR once a month to receive injections of romosozumab or placebo. A designated unblinded healthcare professional will be responsible for administering these injections.
15826434|NCT04232657|Drug|Denosumab|Because there is a high likelihood that the bone accrued while on romosozumab will be lost once discontinued, denosumab, an anti-resorptive agent, will be administered after treatment with romosozumab, to maintain or, possibly, to continue to increase, bone mineral density. Denosumab will be administered to both groups (treatment and placebo) for an additional 12 months. Participants will be asked to arrive at the JJPVAMC once every 6 months to receive injections of denosumab by a healthcare professional.
15826435|NCT04232657|Drug|Placebo|Thirteen (13) of the thirty-nine (39) subjects enrolled in this study will be randomly selected to receive placebo (NS SQ) injections for 12 months (baseline - month 11). The placebo injections will be administered by an unblinded healthcare professional (registered nurse / physician). Participants will be blinded to their group assignment (romosozumab treatment or placebo).
15826436|NCT04232644|Drug|ADAIR 10mg IR capsules|manipulated ADAIR IR 3x10 mg capsules
15826437|NCT04232644|Drug|Crushed d-amphetamine sulfate IR tablets|crushed d-amphetamine sulfate IR 6 x 5 mg tablets
15826438|NCT04232631|Device|IntraOx Vioptix|Vascular imaging device
15826439|NCT04232631|Device|Hyperview, HyperMed Imaging|Vascular imaging device
15826440|NCT04232631|Device|Snapshot NIH, Kent Imaging|Vascular imaging device
15826441|NCT04232618|Diagnostic Test|Multi-biomarker point-of-care test|Lateral flow device containing a combination of markers which have been shown to be associated with active tuberculosis.
15826442|NCT04232605|Other|GLP-1 peptide|Receive intravenous infusion of GLP-1. The dosage will be determined after a dose finding pilot study.
15826443|NCT04232605|Other|Placebo|Receive intravenous infusion saline
15826444|NCT04232592|Biological|Inject a solution of stem cell preparation|The control group was injected with a solution of stem cell preparation
15826445|NCT04232592|Biological|Inject stem cells|Three dose groups were designed: low dose group, medium dose group and high dose group.
15826446|NCT04232579|Other|Therapeutic strategy|Therapeutic strategy compatible with the guidelines and development of predictive biomarkers of the response to treatment.
15826447|NCT04232566|Procedure|Bariatric surgery|we will evaluate liver improvement by elastography before and after gastric bypass surgery. Pt will be followed at 0,3,6,12 months.
15826450|NCT04232540|Device|MedViewer report|Results from the analysis of hair samples performed using the MedViewer
15826451|NCT04232527|Diagnostic Test|Y Balance Test|The footballer will place one foot on the stationary platform of the test set during the test so that the top of the sneaker does not exceed the starting line. The second foot, or the tip of the foot, will push the movable part of the platform down the measuring tube, which is marked by half-inch intervals. Any lifting of the standing leg on the heel, on the toes or loss of balance will be considered a mistake and the attempt will be repeated. Mobility will be tested through 3 trial and 3 valid measurements of the lower limbs in the anterior, posteromedial, and posterolateral directions. The arms should rest on the hips.
15826452|NCT04232527|Diagnostic Test|Sit and Reach Test|This test involves sitting on the floor with your legs stretched straight forward. Shoes should be removed. The feet themselves are set straight against the box. Both knees must be stretched. With the palms facing down and the palms side-by-side or side-by-side, the subject approaches the measurement line as far as possible. It is important to keep your hands in the same position level, not that one reaches further than the other. Once the subject has reached the maximum distance, hold this position for one to two seconds and record the distance.
15826453|NCT04232527|Diagnostic Test|"Maximum Legs Abduction Test"|Seated legs abduction is a test to assess the flexibility of the groin region. Respondent without the shoe sits with its back and head resting against the wall. As a sign, the subject extends the legs (stretches) to the maximum extent. During the test, the legs should not be bent at the knee joint.
15826454|NCT04232527|Diagnostic Test|"S_RAG (reactive agility) Test"|The test consist of fast-moving forward, and a change of direction conditioned by visual stimuli.
15826455|NCT04232527|Diagnostic Test|S_CODS (change of direction speed) Test|S_CODS (change of direction speed) is a test that allows athletes to outperform their opponents in situations where they can pre-define a movement pattern.
15826456|NCT04232514|Drug|HEC74647|Administered HEC74647 200 mg orally once daily in fed state
15826457|NCT04232514|Drug|HEC110114|Administered HEC110114 800 mg orally once daily in fed state
15826458|NCT04232501|Device|Cirvo Compression device|Patients will wear Cirvo compression device during the surgery, after surgery and will be discharged to home with the device to wear at home as the per study protocol instructions.
15826459|NCT04232488|Procedure|coronary angiography using distal radial artery|Patients undergoing coronary angiography with or without percutaneous coronary intervention will be catheterised using distal radial artery ('snuff box'); color doppler will be performed after 3 months to estimate eventual occlusion of the radial artery
15826460|NCT04232488|Procedure|coronary angiography using proximal radial artery|Patients undergoing coronary angiography with or without percutaneous coronary intervention will be catheterised using proximal radial artery; color doppler will be performed after 3 months to estimate eventual occlusion of the radial artery
15826461|NCT04232475|Other|1 minute of stair climbing and descending|1 minute of stair climbing and descending
15826462|NCT04232475|Other|3 minute of stair climbing and descending|3 minute of stair climbing and descending
15826463|NCT04232475|Other|10 minute of stair climbing and descending|10 minute of stair climbing and descending
15826464|NCT04232462|Diagnostic Test|Endoscopists refer to AI for diagnosis|The AI will provide a clinical diagnosis during endoscopy.
15826465|NCT04232449|Drug|PREDNISON Galepharm Tabl. 20 mg|5 daily- doses of 40 mg (2 tablets of 20 mg) of prednisone
15826468|NCT04232436|Other|Survival without severe morbidity|Survival without severe morbidity (IVH, severe BPD, NEC, ROP)
15826469|NCT04232423|Drug|Olanzapine 10 Mg ORAL TABLET|"Olanzapine 10 mg orally, ondansetron 8 mg intravenously, and dexamethazone 8 mg intravenously 30 minutes before chemotherapeutic administration (day 1)
~Olanzapine 10 mg orally daily and dexamethazone 8 mg orally daily on day 2, 3, 4"
15826470|NCT04232423|Drug|Olanzapine 5 Mg ORAL TABLET|"Olanzapine 5 mg orally, ondansetron 8 mg intravenously, and dexamethazone 8 mg intravenously 30 minutes before chemotherapeutic administration (day 1)
~Olanzapine 5 mg orally daily and dexamethazone 8 mg orally daily on day 2, 3, 4"
15826471|NCT04232423|Drug|Placebo ORAL TABLET|"Placebo 1 tab orally, ondansetron 8 mg intravenously, and dexamethazone 8 mg intravenously 30 minutes before chemotherapeutic administration (day 1)
~Placebo 1 tab orally daily and dexamethazone 8 mg orally daily on day 2, 3, 4"
15826472|NCT04232410|Diagnostic Test|Drug induced sleep endoscopy|DISE is performed in a semi-dark, silent operating theatre, starting with the patient in supine position. To first induce sleep, an IV bolus of midazolam (1.5 mg) is administered. Then, a flexible fiberoptic nasopharyngoscope (Olympus END-GP, 3.7 mm diameter, Olympus Europe GmbH, Hamburg, Germany) is inserted through one of the nostrils. Either at the start of the examination or while holding the scope at the level of the palate, propofol (2.0-3.0 µg/ml) will be administered via a target-controlled infusion (TCI) pump. Sleep occurrence is confirmed using the additional EEG measurement.
15826473|NCT04232410|Diagnostic Test|Measurement of critical closing pressure of the uppper airway|After sleep onset, the CPAP pressure well be increased until no flow limitations are observed. This pressure is called the holding pressure and is used as a base for all the following measurements for that individual OSA patient. After observing sleep stage 2 or 3, the holding pressure is reduced abruptly by 1 cmH2O during expiration for 5 breaths. Then the pressure is set back to the holding pressure for the duration of 1 minute. This procedure is repeated until obstructive sleep apnea is noted.
15826474|NCT04232397|Drug|Anlotinib|anlotinib 8mg qd po
15826475|NCT04232384|Procedure|Standard Paracentesis|The patients will be asked to lie supine for 10 minutes and no changes in posture will be allowed for this period. Abdominal paracentesis will be done either by blind technique (in case the ascites is clinically detectable) or ultrasonography guided (in cases the ascites is not clinically detectable).
15826476|NCT04232384|Procedure|Roll Over Paracentesis|Patients with ascites will be rolled over thrice in bed laterally upto 90 degrees on either side (Figure 1) and ascitic fluid sample is drawn within 1 minute of the last rollover. There will be four steps to this i.e roll over to one side at 90 degrees and then 180 degrees to the other side, then back to the first side and then back to the center (to complete three turns). This will be done after the disinfection and cleaning of the anterior abdominal wall have been done and the personnel involved in the procedure are ready for the paracentesis. The ascitic paracentesis will be initiated within one minute of the completion of the turn. One assistant will maintain a stopwatch during this period to ensure compliance with this.
15826479|NCT04232358|Drug|Corticosteroid injection|Corticosteroid injections are administered ultrasound guided in the bursa adjacent to the achilles tendon insertion every 4 weeks until symptoms resolve with at maximum of 3 injections.
15826480|NCT04232358|Drug|Local anesthesia injections|Local anesthesia injections are administered ultrasound guided in the bursa adjacent to the achilles tendon insertion every 4 weeks until symptoms resolve with at maximum of 3 injections.
15826481|NCT04232345|Drug|AZD4831|Subjects will be fasted for at least 10 hours before receiving the AZD4831 in the form of an oral suspension.
15826482|NCT04232345|Drug|Placebo|Subjects will be fasted for at least 10 hours before receiving the placebo in the form of an oral suspension.
15826483|NCT04232332|Drug|Recombinant human nerve growth factor injection,experimental|Intramuscular injection once on the first day according to dose requirements
15826484|NCT04232332|Drug|Recombinant human nerve growth factor injection,single dose|Intramuscular injection once on the first day according to dose requirements
15826485|NCT04232332|Drug|Recombinant human nerve growth factor injection,multiple dose|Intramuscular injection once daily for 7 days according to dose requirements
15826486|NCT04232319|Behavioral|Sleep Hygiene Training|"The intervention will last approximately 45 minutes, and will be provided once/week for 3 weeks. The intervention is delivered live using web-cameras (e.g., Microsoft Zoom).
~Registered and licensed occupational therapists will deliver the intervention. Each week, the interventionist will guide the participant through a workbook to provide knowledge regarding sleep hygiene strategies and examples on how to apply these strategies to improve sleep quality."
15826487|NCT04232306|Drug|Liposomal bupivacaine|Bupivacaine liposome injectable suspension
15826488|NCT04232306|Drug|Bupivacaine HCl|Bupivacaine HCl surgical-site incision infiltration
15826489|NCT04232293|Diagnostic Test|Blood tests|eLift and FibroMeter
15826490|NCT04232280|Biological|mRNA-1647|Lyophilized product that is reconstituted with saline then diluted with a special diluent to reach the desired concentration
15826491|NCT04232280|Other|Placebo|0.9% sodium chloride (normal saline) injection
15826492|NCT04232267|Device|MEB-001|Software medical device used to aid in the screening of patients with potential depressive burden symptoms.
15826493|NCT04232254|Behavioral|Animal-based Protein Foods|Participants will consume animal-based protein foods.
15826494|NCT04232254|Behavioral|Skewed Protein Distribution|Participants will consume 3 meals per day consisting of 10-, 30-, 60% of dietary protein for breakfast, lunch, and dinner, respectively.
15826495|NCT04232254|Behavioral|Plant-based Protein Foods|Participants will consume plant-based protein foods.
15826496|NCT04232254|Behavioral|Balanced Protein Distribution|Participants will consume 5 meals per day consisting of 20% of dietary protein per meal.
15826497|NCT04232241|Drug|Allogeneic Stem Cell Transplantation|Allogeneic Stem Cell Transplantation
15826499|NCT04232215|Device|HeraBEAT™|A wireless Smart Fetal Ultrasound Doppler measuring device designed to be self-administered by the expectant mother throughout the different stages of pregnancy
15826500|NCT04232215|Device|Doppler fetal heart rate monitor|A hand-held ultrasound transducer that uses the Doppler Effect to provide an audible simulation of the heart beat and displays the number of beats per minute.
15826501|NCT04232202|Device|Er:YAG and Nd:YAG lasers|Extraction followed by Er:YAG laser degranulation, Nd:YAG laser disinfection, Er:YAG deepithelialization, Nd:YAG blood clot stabilization and photobiomodulation. The photobiomodulation step repeated on day 3, 5, and 7.
15826502|NCT04232202|Procedure|Standard extraction|Standard extraction procedure
15826503|NCT04232189|Other|no intervention|no intervention, just specimen collection
15826504|NCT04232163|Behavioral|Arm Boot Camp|The intervention involves a combination of daily homework based upper limb exercises and feedback from an activity monitor to motivate use of the affected upper limb. Participants will be supported through virtual sessions with a therapist.
15826505|NCT04232150|Drug|single-dose midazolam for sedation under spinal anesthesia.|Induction of neuraxial anesthesia was done using 2.8cc of 0.5 % Heavy Bupivacaine and 20mcg fentanyl injected intrathecally for all patients. Supplemental oxygen was given via facemask with capnography monitoring. Group O received 0.025mg/kg midazolam at skin incision.
15826506|NCT04232150|Drug|Double-dose midazolam for sedation under spinal anesthesia.|Induction of neuraxial anesthesia was done using 2.8cc of 0.5 % Heavy Bupivacaine and 20mcg fentanyl injected intrathecally for all patients. Supplemental oxygen was given via facemask with capnography monitoring. Group M received 0.025mg/kg midazolam at skin incision and repeated 5 minutes before maximum stimulation.
15826507|NCT04232150|Procedure|spinal anesthesia with no sedation.|Induction of neuraxial anesthesia was done using 2.8cc of 0.5 % Heavy Bupivacaine and 20mcg fentanyl injected intrathecally for all patients. Supplemental oxygen was given via facemask with capnography monitoring.
15826508|NCT04232137|Behavioral|Postpartum coffee ceremony|The promise of a postpartum coffee ceremony
15826510|NCT04232111|Device|Heat|Heat applied to hand
15826511|NCT04232111|Device|Vacuum|vacuum applied to hand
15826512|NCT04232111|Device|sham|neither heat nor vacuum
15826513|NCT04232098|Other|Heat to ankle|Heat administered via hot water to ankle level
15826514|NCT04232098|Other|Heat to calf|Heat administered via hot water to calf level
15826515|NCT04232085|Drug|Alemtuzumab|Preparative regimen
15826516|NCT04232085|Drug|Fludarabine|Preparative regimen
15826517|NCT04232085|Drug|Melphalan|Preparative regimen
15826518|NCT04232085|Radiation|Low Dose Total Body Irradiation|Preparative regimen
15826519|NCT04232085|Drug|Cyclophosphamide|GVHD prophylaxis
15826520|NCT04232085|Drug|Tacrolimus|GVHD prophylaxis
15826521|NCT04232085|Drug|Mycophenolate Mofetil|GVHD prophylaxis
15826522|NCT04232072|Other|Group ESPB|A dose of 100 mg tramadol intravenously will be performed to all patients 30 min before the end of the surgery for postoperative analgesia. At the end of the surgery, local anesthetic infiltration will be perfomed around the port entrance sites by the surgical team to the all patients. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit at the postoperative period.
15826523|NCT04232072|Other|Group Ibuprofen|A dose of 100 mg tramadol intravenously will be performed to all patients 30 min before the end of the surgery for postoperative analgesia. At the end of the surgery, local anesthetic infiltration will be perfomed around the port entrance sites by the surgical team to the all patients. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit at the postoperative period. In Group Ibuprofen, patients will be administered ibuprofen 800 mgr IV every 8 hours in the postoperative period.
15826524|NCT04232059|Device|cerebral oximetry|evaluation of the changes of cerebral oxygen saturation during hyperventilation and normo-ventilation (using near-infrared spectroscopy) in pediatrics undergoing posterior fossa tumor resection.
15826525|NCT04232046|Other|Massage|Massage the trigger points in 8 different points for 1 min in circle direction and 3 times a day.
15826526|NCT04232033|Other|Fibroblast growth factor 21 infusion|Infusion of Fibroblast growth factor 21
15826527|NCT04232033|Other|Placebo infusion (saline)|Infusion of Saline
15826528|NCT04232020|Diagnostic Test|Mismatch repair|MSI testing using Biocartis Idylla and MMR immunohistochemistry
15826529|NCT04232007|Device|closed-loop system for vasopressor administration|closed-loop system for vasopressor administration
15826530|NCT04231994|Device|TPE|singular Therapeutic Plasma Exchange using fresh frozen Plasma as replacement fluid
15826532|NCT04231968|Drug|AK0529|AK0529 capsule will be orally administered at the twice-daily dosing levels of 10 mg, 20 mg, or 40 mg for five days according to the weight of patients.
15826533|NCT04231968|Drug|Matching placebo of AK0529|The placebo capsule was made with the same smell and appearance as AK0529 but without the active ingredients and will be orally administered per the same treatment schedule as those in the experimental arm.
15826534|NCT04231955|Diagnostic Test|numerical rating scale|patients were asked to marked their pain intensity level on numerical rating scale between 0 and 10 and the result was recorded as pain intensity level.
15826535|NCT04231955|Other|visual analogue scale|"Patients were asked to marked their pain intensity level on visual analogue scale, a straight line with one end indicating no pain and the other end indicating worst pain possible. Then the distance between no pain end and patients' mark was measured and recorded as pain intensity level."
15826536|NCT04231955|Other|color analogue scale|"Patients were asked to marked their pain intensity level on color analogue scale, a straight line with one end indicating no pain and the other end indicating worst pain possibleand color change towards to worst pain possible end. Then the distance between no pain end and patients' mark was measured and recorded as pain intensity level."
15826575|NCT04231656|Device|CLEARSIGHT and NICCOMO measurements in sequence A|Starting from 0° position, shift to position +20°, then tilt to -20°, and finally back to the 0° position.
15827219|NCT04226482|Device|New Device|Laparoscopic appendectomy using new ultrasonic shears.
15826537|NCT04231955|Other|faces rating scale|"Patients were asked marked their pain on a faces rating scale which consisted of six different faces representing different levels of pain intensity with the first face indicating no pain whilst last face indicating worst pain possible. The result was recorded as pain intensity level."
15826538|NCT04231942|Device|Graduated Compression Stocking: continuous using|Class 1 (RAL-GZ 387 standard: 18-21 mm Hg at the ankle level) below-knee graduated compression stockings
15826539|NCT04231942|Device|Graduated Compression Stocking: intermittent using|Class 1 (RAL-GZ 387 standard: 18-21 mm Hg at the ankle level) below-knee graduated compression stockings
15826540|NCT04231929|Device|Chemoembolization|"First, an angiography of the celiac trunk, superior mesenteric artery and hepatic artery will be obtained by using a peripheral arterial approach.
~Arterial embolization will be performed through catheterization of intrahepatic arteries, as selectively as possible (tumor feeders, subsegmental, segmental). The size of the microcatheter must be consistent with the size of BioPearl™ microspheres used. Microspheres of 200 µm will be be used. They will be loaded with the appropriate dose of doxorubicin injectable solution, mixed with the contrast media and distributed according to the location of the HCC lesions. The endpoint of the procedure will be achieved end when stasis of the feeders is achieved."
15826541|NCT04231916|Device|Thermal imaging device|
15826542|NCT04231903|Device|Aortic clamp|In the firs group an endo-aortic clamp is used and in the second group an external clamp is used.
15826543|NCT04231890|Other|IPI monitoring|Patients in this arm will have IPI monitoring
15826544|NCT04231877|Drug|Polatuzumab Vedotin|Given IV
15826545|NCT04231877|Biological|Rituximab|Given IV
15826546|NCT04231877|Drug|Prednisone|Given PO
15826547|NCT04231877|Drug|Etoposide|Given IV
15826548|NCT04231877|Drug|Doxorubicin|Given IV
15826549|NCT04231877|Drug|Cyclophosphamide|Given IV
15826550|NCT04231877|Biological|Filgrastim|Given SC
15826551|NCT04231864|Biological|Durvalumab|Given intravenously (IV)
15826552|NCT04231864|Drug|Epacadostat|Given orally (PO)
15826553|NCT04231851|Drug|Glasdegib|Given PO
15826554|NCT04231851|Drug|CPX-351|Given IV
15826555|NCT04231838|Other|TOBACCO CIGARETTES|Participants in Arm A will continue smoking their own cigarette brand as usual.
15826556|NCT04231838|Other|COMBUSTION-FREE NICOTINE DELIVERY SYSTEMS (C-F NDS)|Participants in Arm B will trial and familiarize with their allocated products to select the C-F NDS of their preference. They will be trained and counselled on the chosen C-F NDS; participants will also have the option to try and choose among a selection of either 3 e-liquids or 3 tobacco sticks (depending on the C-F NDS they have chosen). Participants wishing to use a heated tobacco device (HTD) will receive one kit and a full 1 week supply of tobacco sticks of their choice (they will receive a number of tobacco sticks/day corresponding to the number of cigarettes smoked at baseline); those wishing to use a vaping product will receive one vaping kit and a full 1 week supply of e-liquids of their choice (they will receive 4 x 10 ml refill containers).
15826558|NCT04231812|Device|Laparoscopic Tissue Morcellation working space (bag)|"The LapBox is working space (bag) intended for use as a laparoscopic instrument port and tissue containment system that creates a working space allowing for visualization during power or manual morcellation procedure following a laparoscopic procedure for the excision of benign gynecologic tissue that is not suspected to contain malignancy"
15826559|NCT04231799|Procedure|Bathing|Traditionally, it is the process of washing the newborn in the first hours of life to remove blood, meconium, varnish and other infectious substances.
15826560|NCT04231786|Procedure|Breast ultrasonography findings|Breast ultrasonography findings in patients over 30 years of age diagnosed with polycystic ovary syndrome.
15826561|NCT04231773|Drug|Nitric Oxide|40 parts per million dosage
15826562|NCT04231773|Drug|Placebo|Inhaled placebo. Device connected to same delivery system, but does not deliver nitric oxide.
15826563|NCT04231760|Drug|Inhaled Nitric Oxide|Inhaled nitric oxide, which consists of breathing medical grade air (21% O2) with 40 parts per million of nitric oxide.
15826564|NCT04231760|Drug|Placebo|Inhaled placebo, which consists of breathing medical grade air (21% O2).
15826565|NCT04231747|Biological|CC-97540|"Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) to produce CC 97540.
~During CC 97540 production, subjects may receive bridging chemotherapy for disease control. Upon successful generation of CC 97540 product, subjects will receive treatment with CC 97540 therapy.
~Each cycle will include lymphodepleting chemotherapy followed by one dose of CC 97540 administered by intravenous (IV) injection."
15826566|NCT04231734|Other|Ketogenic Diet|Prepared ketogenic meals, 3 per day for up to 12 weeks (Day 1 through Day 84)
15826567|NCT04231721|Device|High Resolution Colonic Manometry and 3D-Transit system|Measurement of colonic pressure changes and passage patterns in healthy.
15826568|NCT04231708|Drug|Yohimbine + Hydrocortisone|Yohimbine (54mg bulk powder inside capsule) administered in combination with Hydrocortisone (20mg tablet inside capsule)
15826569|NCT04231708|Device|Active rTMS|10Hz rTMS over the left dlPFC
15826570|NCT04231708|Drug|Placebo|lactose (inside capsule)
15826571|NCT04231708|Device|Sham rTMS|inactive stimulation over the left dlPFC
15826572|NCT04231682|Drug|Denosumab Injection|Use of denosumab in post liver transplant patient for prevention and management of osteoporosis and bone loss.
15826573|NCT04231682|Drug|Placebos|Use of placebo in post liver transplant patient for prevention and management of osteoporosis and bone loss.
15826574|NCT04231669|Behavioral|Anzansi Family Program|"the ANZANSI that combines Family Economic Empowerment (EE) with Multiple Family Groups (MFG). Family EE includes: 1) Workshops on asset building, future planning, and protection from risks; 2) Child Development Account (CDA); and 3) Family income-generating/microenterprise promotion (IGA) component:
~MFG a family-centered, group-delivered, evidence-informed intervention designed for children and adolescents whose families struggle with poverty and associated stressors. The MFG is based on building family support through opportunities for parents and children to communicate in a safe setting with other families who have shared experiences, and allow each family to learn from one another. MFG builds protective factors for healthy parent-child relationships while addressing familial, social and community stressors and barriers to adolescent girls' well-being."
15826576|NCT04231656|Device|CLEARSIGHT and NICCOMO measurements in sequence B|Starting from 0° position, shift to position -20°, then tilt to +20°, and finally back to the 0° position and collect the last group of figures.
15826577|NCT04231643|Drug|Dronabinol|one-time oral administration of 5 mg dronabinol
15826578|NCT04231643|Drug|Epidiolex|one-time oral administration of 600 mg Epidiolex
15826579|NCT04231643|Drug|Placebos|one-time oral administration of placebo
15826580|NCT04231630|Other|Prolacta|Will receive outpatient supplementation with donor human milk product added to mother's own milk
15826581|NCT04231617|Drug|glibenclamide|Oral administration of glibenclamide or placebo. To investigate the role of CGRP on cranial arteries in healthy volunteers after glibenclamide/placebo administration .
15826582|NCT04231617|Drug|CGRP infusion|CGRP infusion
15826583|NCT04231617|Drug|Placebo|placebo
15826584|NCT04231604|Behavioral|A Lust for Life|A Lust for Life is a universal school-based multi-component programme whose target is to build well-being and emotional resilience in adolescents. The programme was informed by evidence-based psychological approaches including mindfulness, cognitive behaviour therapy and positive psychology. It is delivered in six weekly lessons by the adolescents' school teacher and involves classroom discussions, videos, classroom activities and homework assignments.
15826585|NCT04231604|Behavioral|Waiting list control|Control group placed on a twelve-week waiting list.
15826586|NCT04231591|Diagnostic Test|NT-proBNP|Collect serum NT-proBNP levels in singleton ACHD patients and a comparative normotensive control group at time of admission for delivery to characterize negative predictive values for intrapartum and postpartum cardiac events.
15826587|NCT04231578|Behavioral|Couple HOPES Guided, Internet-Delivered, Self-Help Intervention|Couple HOPES is a guided self-help intervention for individuals with PTSD and their partners based on Cognitive-Behavioral Conjoint Therapy for PTSD (Monson & Fredman, 2012). This intervention consists of text and video-based content across seven intervention modules and phone and online-based coaching sessions with a paraprofessional. Participants are able to complete these modules in their own home or private location of their choosing. The primary outcomes are PTSD symptoms, relationship satisfaction, and the mental health and wellbeing of partners of those with PTSD.
15826588|NCT04231565|Drug|Tenofovir alafenamide Fumarate|Patients would receive treatment of oral Tenofovir alafenamide Fumarate（TAF）once per day.
15826589|NCT04231552|Drug|Camrelizumab|Radiotherapy with CAPOX+ Camrelizumab following surgical therapy Radiation: 25 Gy/5 fractions CAPOX (2 cycles): Oxaliplatin(130mg/m2) on day 1 of each cylce and Capecitabine:Dose of 2000mg/m2,14days, q3w Camrelizumab (2 cycles): 200mg on day 1 of each cycle, q3w Surgical therapy: the resection (LAR), intersphincteric resection (ISR), or abdominoperineal resection (APR)
15826590|NCT04231539|Drug|Nicotine|Vape different flavor nicotine products
15826591|NCT04231539|Device|Vaporizer Device|Take puffs from vaporizer filled with different flavors
15826592|NCT04231526|Drug|Pembrolizumab|2 cycles of neoadjuvant pembrolizumab (200mg IV every 21 days)
15826593|NCT04231526|Procedure|Surgery|Standard of care surgery
15826594|NCT04231513|Drug|E2814|E2814, intravenous infusion.
15826595|NCT04231513|Drug|E2814-matched placebo|E2814-matched placebo, intravenous infusion.
15826596|NCT04231500|Diagnostic Test|Skin swabs|Pre-moistened skin swabs will be collected before the patient starts the conditioning regimens (before conditioning; start of HSCT = day 0, on the day of the transplantation an the repeated in week 4, 12, 24, 36 and 52 after allo-HSCT. The first swab serves as baseline reference (ideally taken at the earliest one week after a systemic antibiotic treatment). Swabs will be taken from the neck, back, right hip, buccal oral cavity and the genital mucosae. In patients who develop acute or chronic skin-GVHD additional swabs will be taken from affected skin at the time of diagnosis and then again according to the schedule of the non-lesioned skin swabs.
15826597|NCT04231500|Diagnostic Test|Skin punch biopsies|During the first visit, a single skin punch biopsy will be taken to state the skin condition and microbiome before allo-HSCT. Further biopsies will only be taken in case of acute or chronic cutaneous GVHD. A 4-6 mm punch biopsy will be taken from the affected skin area and a second one from a nearby unaffected part of the skin. Before the biopsy, skin disinfection will be performed to avoid contamination with surface bacteria.
15826598|NCT04231500|Diagnostic Test|additional blood sampling|an additional tube of blood (2.7ml) and an additional tube of serum (6ml) will be taken and frozen during visits 1, 2, 3 and 7 in the course of blood collection, in order to be able to carry out any later laboratory tests that may prove to be useful depending on the course of the study.
15826599|NCT04231474|Device|Urodynamic testing|All data were obtained using the MMS Alfa 4T by the same urologist with use of an 8 Charr catheter.
15826600|NCT04231461|Procedure|Cardiac Surgery|Routine or urgent cardiac surgery
15826601|NCT04231448|Drug|R-CHOP(Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone)|R-CHOP : rituximab 375 mg/m2 IV, cyclophosphamide 750 mg/m2 IV, doxorubicin 50 mg/m2 IV, vincristine 1.4 mg/m2 IV [maximum total 2 mg], and prednisone [or equivalent] 100 mg orally as the background therapy for 6 cycles (21 days/cycle).
15826602|NCT04231448|Drug|Tucidinostat|Tucidinostat ：30 mg was given orally after breakfast on day 1, day 4, day 8, day 11 in a 21-day cycle，for 6 cycles. After cycle 6 patients who are evaluated as complete response will receive 24 weeks additional administrations of Tucidinostat on day 1, day 4, day 8, day 11 in a 21-day cycle.
15826603|NCT04231448|Drug|Placebo|Placebo：30 mg was given orally after breakfast on day 1, day 4, day 8, day 11 in a 21-day cycle，for 6 cycles. After cycle 6 patients who are evaluated as complete response will receive 24 weeks additional administrations of placebo on day 1, day 4, day 8, day 11 in a 21-day cycle.
15826604|NCT04231435|Drug|Fedratinib|Oral
15826605|NCT04231435|Drug|Digoxin|Oral
15826606|NCT04231435|Drug|Rosuvastatin|Oral
15826607|NCT04231435|Drug|Metformin|Oral
15826608|NCT04231422|Combination Product|Platelet-rich plasma|12mL of platelet-rich plasma injected into cavernosal bodies bilaterally
15826609|NCT04231409|Device|Boston Scientific Spectra WaveWriter SCS System|The Spectra WaveWriter Spinal Cord Stimulator (SCS) System is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain.
15826610|NCT04231396|Other|Audiobooks for hearing loss|Same as Arm 1
15826611|NCT04231383|Other|dental caries, growth parametres|"The comparison of growth parameters before and after 6 months of treatment of dental caries will be compared.
~Children's Sleep Habits Questionnaire and Early Childhood Oral Health Impact Scale will be compared before and at the 6th month of dental treatment."
15826612|NCT04231370|Drug|Sintilimab|Sintilimab, 200mg, iv day1
15826613|NCT04231370|Drug|Lenalidomide|25mg/d oral d1-14
15826614|NCT04231357|Drug|platelet rich plasma|platelet rich plasma prepared from peripheral blood using single spin centrifugation
15826615|NCT04231344|Device|Laryngoscopy|Laryngoscopic examination of patients with GERD by two physicians
15826616|NCT04231331|Drug|Ertugliflozin|Ertugliflozin 5mg qd for 12 months
15826617|NCT04231331|Drug|Placebo|Placebo qd for 12 months
15826618|NCT04231318|Drug|Cingal|A chemically cross-linked sodium hyaluronate supplied as a 4-mL unit dose with a nominal 18 mg of triamcinolone hexacetonide (TH)
15826619|NCT04231318|Drug|Triamcinolone Hexacetonide - Lederlon|20 mg/ml supplied as 1 mL unit dose of Triamcinolone Hexacetonide
15826620|NCT04231318|Drug|Placebo|0.9% Saline
15826621|NCT04231292|Drug|RD01|RD01 is a PEGylated recombinant human erythropoietin with the same biological effects as natural erythropoietin
15826622|NCT04231292|Drug|Recombinant Human Erythropoiesis Injection (CHO cell)|rHuEPO is a recombinant human erythropoietin with the same biological effects as natural erythropoietin
15826623|NCT04231292|Drug|placebo|placebo
15826624|NCT04231279|Drug|synthetic human secretin|Secretin is a gastrointestinal peptide hormone, indicated for the stimulation of: pancreatic secretions, including bicarbonate, to aid in the diagnosis of pancreatic exocrine dysfunction.
15826625|NCT04231266|Drug|ManNAc|Oral N-acetyl-D-mannosamine monohydrate (ManNAc)
15826626|NCT04231266|Other|Placebo|Placebo
15826627|NCT04231240|Device|Measure of ACT with IStat|Measure of ACT with a point of care device named IStat
15826628|NCT04231214|Drug|Olodaterol-Tiotropium|5µg Olodaterol and 5 µg Tiotropium via the soft mist inhaler Respimat®, administered once on Day 1 or Day 9 and daily from Day 10 to Day 24
15826629|NCT04231175|Diagnostic Test|DWI MRI of the pelvis, abdomen and thorax|Patients in Arm A will receive a MRI scan of their pelvis, abdomen, and thorax before possible surgery. During the MRI standard Gadolinium contrast agent and Buscopan is intravenously administered, which is standard clinical practice in abdominal MR imaging. Total scan time is 35 minutes and includes T2 weighted, T1 weighted, Diffusion weighted and dynamic contrast enhanced imaging of the abdomen and the thorax. The findings of this scan will be used to determine whether to proceed with CRS/HIPEC, DLS and then possibly CRS-HIPEC, or palliative care.
15826630|NCT04231162|Dietary Supplement|Active product|Bifidobacterium lactis HN019 (probiotic powder). One capsule to consume orally with still water (not sparkling) at room temperature once a day at least 15 minutes before breakfast time.
15826631|NCT04231162|Dietary Supplement|Control product|Placebo. One capsule to consume orally with still water (not sparkling) at room temperature once a day at least 15 minutes before breakfast time.
15826632|NCT04231149|Device|Test product 2|Test catheter 2
15826633|NCT04231149|Device|Test product 3|Test catheter 3
15826634|NCT04231149|Device|Comparator|SpeediCath Flex
15826635|NCT04231136|Drug|Tegoprazan 50 mg|Tegoprazan 50 mg tablet
15826636|NCT04231136|Drug|EAPA115|EAPA115
15826637|NCT04231136|Drug|RAPA115|RAPA115
15826638|NCT04231123|Procedure|PENG Block with local anesthetic|After induction of general anesthesia, PENG block with 20 ml of a mixture of 1% Lidocaine with 0,5% Ropivacaine and 1/400.000 Epinephrine will be performed as described by Giron-Arongo et al with a high frequency linear probe. A 22G 80 mm needle (SonoPlex, Pajunk ) will be used.
15826639|NCT04231123|Procedure|PENG Block with 0,9% saline|After induction of general anesthesia, PENG block with 20 ml of 0,9% saline will be performed as described by Giron-Arongo et al with a high frequency linear probe. A 22G 80 mm needle (SonoPlex, Pajunk ) will be used.
15826640|NCT04231110|Biological|Fecal microbiota transplantation|Use of fecal microbiota transplantation enemas once weekly in patients who are initiating vedolizumab treatment
15826641|NCT04231097|Other|MBCT intervention for ACS patients|The MBCT intervention will involve 8 virtually-delivered MBCT sessions (approximately 1.5 hours each), during which participants will be taught how to use evidence-based mindfulness skills to regulate distress and choose healthy behaviors, as well as learn about cardiac health. Participants involved in the intervention will be asked to complete a brief survey following each session. Within one week before and after the intervention and 3-months post-intervention participants will be asked to complete a series of questionnaires and provide self-collected blood samples. Upon completion of the intervention participants will complete an audio-or video recorded exit interview (approximately 30 minutes).
15826642|NCT04231084|Drug|Vasodilator testing (Inhaled Nitric Oxide)|Right heart catheterization with vasodilator testing with each arms' associated agent will be performed
15826643|NCT04231084|Drug|Vasodilator testing (Inhaled Epoprostenol)|Right heart catheterization with vasodilator testing with each arms' associated agent will be performed
15826644|NCT04231071|Device|Onlay Mesh group|Primary suture repair with a small only mesh on the closed defect
15826645|NCT04231058|Device|TENS and pulmonary rehabilitation|Three treatments with TENS per week for 3 weeks each , lasting 45 minutes
15826646|NCT04231045|Device|PiCCO device cardiac monitoring|"PiCCO is a cardiac output monitor that combines pulse contour analysis and transpulmonary thermodilution technique.Haemodynamic monitoring
~especially if complex mixed forms of shock (e.g. septic and cardiogenic) PAC unavailable or contra-indicated"
15826745|NCT04230291|Behavioral|Verbal consultation|Verbal consultation only without written information before receiving written action plan
15826746|NCT04230291|Behavioral|Written Action Plan|Written handout of treatment plan and disease management strategies
15826747|NCT04230278|Behavioral|START-Play Physical Therapy|Physical Therapy focused on movement and cognitive skills at the same time
15826649|NCT04231019|Other|self-administered questionnaire|"Self-administered questionnaires with plain language statements and brief description of the clinical features and photographs of MIH were used to determine the knowledge, awareness and perception regarding the prevalence, severity, etiology and treatment modalities of molar-incisor hypomineralization (MIH) among Egyptian fifth year dental students, general dental practitioners and dental specialists.
~There were two routes for delivering the questionnaire either as online questionnaire sent to the participants by email or as a hard copy that is hand delivered."
15826650|NCT04231006|Radiation|High dose rate brachytherapy|High dose rate brachytherapy will be delivered to the site of recurrence within the prostate gland based on MRI and PSMA PET/CT
15826651|NCT04230993|Other|Sea water solution|Administration of different sea water solution is performed and the rating of cold symptoms according to the Jackson scale, the fluidity of mucus and the ease of blowing will be evaluated.
15826652|NCT04230980|Drug|Gabapentin|Gabapentin 600mg tablet
15826653|NCT04230980|Drug|Placebo|Placebo tablet
15826654|NCT04230967|Behavioral|Ambulation Group|Participants in the ambulation arm will be allowed ad lib activity and instructed that they should walk at least once per day out of their room with a goal of 2,000 steps per day. The Fitbit Inspire devices will be set to this goal and notifications will be given on the device for the participants meeting their goals
15826655|NCT04230967|Behavioral|Routine Care|No encouragement to ambulate will be provided to subjects. Their movement will be recorded
15826656|NCT04230954|Drug|Cabozantinib 40 MG oral once a day|Cabozantinib 40 mg oral once a day
15826657|NCT04230954|Drug|Pembrolizumab 200 mg IV every 3 weeks|Pembrolizumab 200 mg IV every 3 weeks
15826658|NCT04230941|Behavioral|MAAT-G|Memory and Attention Adaptation Training (MAAT) is a cognitive-behavioral therapy (CBT)-based intervention for CRCD. As a CBT-based intervention, MAAT focuses on an individual's psychological response to injury as compared to the biological events triggering CRCD. MAAT is a series of manualized workshops delivered by a psychologist via video-conferencing, supplemented by a participant workbook, which provide instruction and practice with adaptive behavioral coping skills, stress management techniques, and compensation strategies. MAAT-G will be evaluated in up to 10 patient-caregiver dyads to further adapt MAAT-G to optimize usability.
15826659|NCT04230928|Other|Very low carbohydrate diet|Participants will learn to follow a very low carbohydrate diet in modified versions of GLB modules 2,3,5 & 10. Participants will learn to track carbohydrate intake
15826660|NCT04230928|Other|Standard DPP-GLB diet|Participants will learn to follow a very low fat, calorie-restricted diet and track fat grams and caloric intake in standard GLB modules 2,3,5, & 10
15826661|NCT04230928|Behavioral|Standard DPP-GLB program modules|Participants will learn standard DPP-GLB modules for other lifestyle modifications for stress, physical activity, etc. in sessions 1,4,6-9, 11-22
15826662|NCT04230915|Other|Intraoperative nerve monitoring|This group will determine as those who were administered 0.3 mg/kg rocuronium,
15826663|NCT04230902|Biological|Microfragmented Adipose Tissue Transplant|Autologous Microfragmented Adipose Tissue derived using Lipogems® Kit
15826664|NCT04230902|Drug|Corticosteroid injection|intra-articular knee injection of corticosteroid
15826665|NCT04230889|Other|Usual Diet Group|three main meals and two snacks
15826666|NCT04230889|Other|Group 1 Nutritional Shake|2 servings per day
15826667|NCT04230889|Other|Group 2 Nutritional Shake|2 servings per day
15826668|NCT04230876|Behavioral|Auditory Brian Training Games/Activities|Game-based activities that encourage listening to words and sentences in noisy situations. Participants will receive subscriptions to the clEAR online auditory training activities and recommended protocol for those who recently received new hearing aids.
15826669|NCT04230863|Behavioral|Neuroplasticity-based Computerized Cognitive Remediation|"The nCCR has two major components: Bottom up and Top down training. Bottom up training: The training includes selected tasks from Brain HQ, a program designed for older adults, that enhances basic processing of sensory stimuli with the goal to improve fidelity of auditory and visual encoding.
~Top down training: We designed programs to target cognitive control functions associated with poor treatment response, i.e., initiation and use of verbal strategy and susceptibility to interference. These Top Down Programs include a visual attention program, either Catch the Ball or Neurogrow, and a semantic strategy program, Semantic Organization."
15826670|NCT04230850|Other|Static Cupping|Two cups will be applied unilaterally to the lumbar paraspinals. The skin will be elevated to 1.5 cm ensuring standardized pressure. Cups will remain on the treatment area statically for 4 minutes prior to removal. Another 4 minute bout of identical treatment to the contralateral side will follow. (Participants will be equally dispersed into three treatment groups via stratified randomization).
15826671|NCT04230850|Other|Dynamic Cupping|One cup will be applied ipsilaterally, raising skin to 1.2 cm of standard pressure. The cup will be continuously moved in a sweeping motion between L1 and L5 within a defined width. This process will be repeated on the other side. Each side will be treated for 4 minutes dynamically for a total treatment duration of 8 minutes. (Participants will be equally dispersed into three treatment groups via stratified randomization).
15826672|NCT04230850|Other|Stretching|The stretching program performed will involve a double knee to chest stretch, cat stretch, camel stretch, and pelvic tilts. Participants will receive a 30 second rest break between each of the four stretches. (Participants will be equally dispersed into three treatment groups via stratified randomization).
15826673|NCT04230837|Device|Inmediate abutment height|The placement of the implant was done following the manufacturing protocol and using a surgical guide according to the radiological guide previously used. At this time, the Permanent® abutment of 1 or 3 mm was chosen randomly and was placed at 35 Ncm.
15826674|NCT04230824|Dietary Supplement|Pre-workout plus and Protein recovery plus|products consumed prior and after exercise
15826675|NCT04230824|Other|Placebo|placebo product consumed prior and after exercise
15826676|NCT04230824|Other|6-week resistance training program|participants will complete a moderate-intensity warm-up, a full-body resistance training workout (2 x per week) and an interval training session (1 x per week)
15826677|NCT04230811|Diagnostic Test|Corneal impression membrane (Millicell Cell Culture Insert, 12mm, hydrophilic PTFE 0.4µm (PICM01250))|Application of corneal membrane to the cornea for 3-5 seconds, after anaesthesia
15826748|NCT04230278|Behavioral|Usual Care Physical Therapy|Physical Therapy focused on movement and reducing impairments
15826749|NCT04230265|Drug|Cyclophosphamide (Non-IMP)|Intravenous infusion for 3 days
15826678|NCT04230798|Other|Injury prevention program|The intervention program consisted in 16 sessions, performed during eight weeks, twice per week. Intervention group performed 20 minutes sessions before their habitual volleyball training. The structure of the prevention program consisted in a warm up, a lower limb strength exercise; two core exercises; a lower limb plyometric exercise, and a lower limb stability exercise. While the injury prevention program was being performed, both groups continued with their volleyball training sessions.
15826679|NCT04230785|Genetic|Sequencing of circRNA/lncRNA/miRNA|Next generation sequencing and quantitative real-time polymerase chain reaction of circular RNA (circRNA), long non-coding RNA (lncRNA) and micro-RNA (miRNA)
15826680|NCT04230772|Procedure|Natural Orifice Specimen Extraction Surgery|In the experimental group, patients will be performed robotic colorectal resection with natural orifice specimen extraction.
15826681|NCT04230772|Procedure|Traditional Robotic-assisted Surgery|In the active comparator group, patients will be performed traditional robotic-assisted colorectal resection.
15826682|NCT04230759|Drug|Chemotherapy|"Patients recieve chemotherapy cycles as followed:
~Mitomycin-C 12 mg/m², day 1 (maximum single dose 20 mg) 5-FU: 1000 mg/m² per day, continuous i.v. infusion, on day 1-4 and 29-32"
15826683|NCT04230759|Radiation|Radiation|PTV_A (primary tumor): T1-T2<4cm N+: 28 x 1.9 Gy=53.2 Gy, five fractions per week or PTV_A (primary tumor): T2>=4cm, T3-4 Nany: 31 x 1.9 Gy=58.9 Gy, five fractions per week PTV_N (involved node): 28 x 1.8 Gy=50.4 Gy, five fractions per weeks PTV_Elec (elective node): 28 x 1.43 Gy=40.0 Gy, five fractions per week
15826684|NCT04230759|Drug|Durvalumab|1500 mg, 1h-civ, every 4 weeks (q4w) applied on day -14 (that is 14 days prior to initiation of RCT), day 15 (during RCT), and thereafter q4w (+/- 3d) for a total of 12 doses
15826685|NCT04230746|Drug|Bactrim DS 800Mg-160Mg Tablet|To study effect on urinary microbiome
15826686|NCT04230746|Drug|Placebo oral tablet|To study effect on urinary microbiome
15826687|NCT04230720|Drug|Systane Complete|1 drop 4 times a day for 14 days
15826688|NCT04230707|Other|Endogenous Melatonin Levels|High Endogenous Melatonin Levels is Group 1 Low Endogenous Melatonin Levels is group 2
15826689|NCT04230694|Device|Dexcom Generation 6 CGM (Dexcom Gen6) device|Standing orders for blood sugars less than 100 will allow for administration of glucose replacement in the intervention group based on Dexcom Gen6 readings.
15826690|NCT04230681|Drug|Hydromorphone|Patients will be randomized to one of two opioids for the treatment of post-operative pain.
15826691|NCT04230681|Drug|Fentanyl|Fentanyl
15826692|NCT04230668|Behavioral|Cognitive Processing Therapy with Suicide Risk Management|CPT is an evidence-based treatment for PTSD. This first-line treatment for PTSD will be adapted and combined with SRM into 12 60-90min sessions targeting both PTSD and BPD. Individuals assigned to this intervention will attend treatment sessions, and be asked to do treatment homework at home. The primary outcomes are PTSD and BPD severity.
15826693|NCT04230655|Dietary Supplement|Low energy diet using meal replacements|The LED phase (from baseline to 24 weeks) consists of 12 weeks with 4 portions/day of liquid meal replacements, for a total of 800-880 kcal/day, followed by a 12-week slow phasing out to a regular diet. Thereafter, an energy-reduced diet (1400-1600 kcal/day) is recommended.
15826694|NCT04230655|Behavioral|CBT-based group treatment|All participants (control and intervention) receive 2.5-hour sessions of CBT-based group treatment every 4 weeks for 1 year. Participants are randomly assigned to groups of 8-16 participants.
15826695|NCT04230655|Device|Intragastric balloon|An IGB (Orbera IGB, Apollo Endosurgery Inc., Austin, Texas, (CE certified)) is set in place endoscopically by a gastroenterologist at Örebro University Hospital, Region Örebro county, and is left in the stomach for 6 months. A proton-pump inhibitor is prescribed to counteract an increased risk to develop a gastric ulcer. During the first 2 weeks, dietary adjustments are necessary to adapt to the IGB. Thereafter, an energy-reduced diet (1400-1600 kcal/day) is recommended identical to the control group. The IGB is removed endoscopically after 6 months IGB treatment.
15826696|NCT04230642|Device|The Quantum Surgical device|Robotic platform for needle placement
15826697|NCT04230629|Device|Vivinex XY1|Implantation of an intraocular lens Hoya Vivinex XY1
15826698|NCT04230629|Device|Vivinex XY1A|Implantation of an intraocular lens Hoya Vivinex XY1A
15826699|NCT04230616|Procedure|total knee arthroplasty|total knee arthroplasty
15826700|NCT04230616|Radiation|CT scan|The first 52 participants will recieve a pre- and postoperative CT scan of the hip, knee and ankle.
15826701|NCT04230603|Procedure|Hyperspectral imaging|Photos were taken with the hyperspectral camera of the human tissue
15826702|NCT04230603|Diagnostic Test|Lactate acid measurement|At the marked regions of the specimen, a lactate acid measurement was performed.
15826703|NCT04230603|Diagnostic Test|pathological examination|At the marked regions of the specimen, the pathological examination was performed.
15826704|NCT04230590|Other|Observational|"Participants will not receive any study intervention.
~During the 24-week study period, participants will complete five assessment visits and passive digital data from participant's smartphone and study-provided wrist wearable device will be collected."
15826705|NCT04230577|Device|Real LED Intervention|A series of Real at-home, transcranial LED treatments (3xWeek, 5 weeks), 20-minute treatment, 810nm (NIR), Vielight Neuro Alpha Head Frame Device (with NIR intranasal).
15826706|NCT04230577|Device|Sham LED Intervention|A series of Sham at-home, transcranial LED treatments (3xWeek, 5 weeks), 20-minute treatment, Vielight Neuro Alpha Head Frame Device (with intranasal) with Sham LEDs that emit no photons. Sham and Real Devices look and feel identical.
15826707|NCT04230564|Drug|azacitidine|Patients taking azacitidine
15826708|NCT04230564|Drug|venetoclax|patients taking venetoclax
15826709|NCT04230564|Drug|glasdegib|patients taking glasdegib
15826710|NCT04230551|Procedure|PTSMA|Alcohol Septal Ablation
15826711|NCT04230538|Device|DJO Walker|
15826712|NCT04230538|Device|Traditional plaster cast|
15826750|NCT04230265|Drug|Fludarabine (Non-IMP)|Intravenous infusion for 3 days
15826751|NCT04230265|Drug|TM123 (IMP)|Intravenous Infusion for 25 days
15826752|NCT04230265|Drug|UniCAR02-T (IMP)|Intravenous infusion of single dose
15826753|NCT04230252|Drug|Acetaminophen|Acetaminophen tablet will be administered orally in treatment sequence 1 and 2.
15826837|NCT04229472|Diagnostic Test|Cardiac Magnetic Resonance Imaging|Late gadolinium enhance cardiac magnetic resonance imaging (in AcQMap group only)
15826713|NCT04230525|Diagnostic Test|non invasive whole body bioimpedence system|Noninvasive hemodynamic changes will be observed by using whole-body impedance method urgent or elective cesarian section patients under general anesthesia. The whole-body bioimpedance method will be used to monitör the hemodynamic changes non invasively. This method can evaluate such as cardiac output, cardiac index, stroke volüme, stroke index, stroke volüme variations, cardiac reserve, etc. Parameters with a completely noninvasive method by using only electrots. The device consists of a laptop, a software which calculates cardiac parameters and two electrodes. The measurement is done by the following process: one of these electrodes, which looks like ECG electrodes, is stuck to the wrist and the other one to the opposite ankle or each one to two wrists.
15826714|NCT04230512|Other|Pump prototype|Effects of pump function on gait
15826715|NCT04230499|Drug|Encapsulated Rapamycin (eRapa)|eRapa is encapsulated rapamycin. The rapamycin is encapsulated in order to deliver the rapamycin at a consistent and lower dosage. eRapa is a capsule, and is administered orally.
15826716|NCT04230473|Biological|single dose of CNCT19|"Dose A: 0.25 x 10^8 autologous CNCT19 transduced cells via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide
~Dose B: 1.00 x 10^8 autologous CNCT19 transduced cells via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide
~Dose C: 2.00 x 10^8 autologous CNCT19 transduced cells via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide"
15826717|NCT04230460|Drug|Cannabis (THC) (Inhaled) Placebo|Cannabis vapor is produced from 500 mg of dried plant material (placebo) (0% THC). Participants will inhale ad libitum over 10 minutes.
15826718|NCT04230460|Drug|Cannabis (High% THC) (Inhaled)|Cannabis vapor is produced from 500 mg of dried plant material (7.5% THC). Participants will inhale ad libitum over 10 minutes.
15826719|NCT04230460|Drug|Cannabis (Very High% THC) (Inhaled)|Cannabis vapor is produced from 500 mg of dried plant material (12.5% THC). Participants will inhale ad libitum over 10 minutes.
15826720|NCT04230460|Drug|Alcohol (oral)|Subjects will be dosed to achieve a 0.05% Blood Alcohol Concentration (BAC), so the amount of alcohol consumed will be calculated to produce a peak BAC of 0.065%. Subjects will be served three equal-sized drinks, 10-minutes apart, and be instructed to pace each drink evenly over the 10-minute period.
15826721|NCT04230447|Other|No intervention|No intervention
15826722|NCT04230434|Behavioral|Safety Plan Intervention|The SPI has 6 key steps: (1) identify personalized warning signs for an impending suicide crisis; (2) determine internal coping strategies that distract from suicidal thoughts and urges; (3) identify family and friends who are able to distract from suicidal thoughts and urges and social places that provide the opportunity for interaction; (4) identify individuals who can help provide support during a suicidal crisis; (5) list mental health professionals and urgent care services to contact during a suicidal crisis; and (6) lethal means counseling for making the environment safer (Stanley & Brown, 2012)
15826723|NCT04230421|Device|The Monsenso system with feedback|See description under intervention
15826724|NCT04230421|Device|The Monsenso system without feedback|See description under intervention
15826725|NCT04230421|Device|CAG Bipola and mood monitoring only|See description under intervention
15826726|NCT04230408|Drug|Durvalumab|Intensified chemo-immuno-radiotherapy with durvalumab in combination with carboplatin, paclitaxel and radiation
15826727|NCT04230395|Behavioral|CAP|4-session combination Motivational Enhancement Therapy and Cognitive Behavioral Therapy alcohol reduction intervention. The intervention will also include 3 booster sessions.
15826728|NCT04230395|Other|Usual Care|Provider advice to reduce alcohol use per recommended standard of clinical care, and referral to treatment as indicated
15826729|NCT04230382|Diagnostic Test|Diagnosis of diabetes (OGTT)|Blood sample will be collected for glucose, HbA1c and magnesium. Standard OGTT will be conducted with 75g of glucose (repeated, if disgnostic).
15826730|NCT04230369|Behavioral|Exposure-based Internet-CBT|Internet-CBT for anxiety-related asthma 8 weekly modules of CBT delivered over the internet and targeting enhanced function and decreased symptoms of anxiety. Participants work independently from home with the treatment and receive support from experienced Internet-CBT Psychologists through written messages in the secure platform. All participants in both conditions can use any other available treatment (TAU), but psychological, from pre-assessments to 2 months after treatment completion.
15826731|NCT04230369|Other|Treatment as usual|Patients randomized to treatment as usual will receive the same medical information that participants in the Internet-CBT get, with physiological information about asthma and the importance of medical adherence to achieve well controlled asthma, but without the exposure-based treatment and no therapist support. All participants in both conditions can use any other available treatment (TAU), but psychological, from pre-assessments to 2 months after treatment completion.
15826732|NCT04230356|Biological|Viral Specific T-cells (VSTs) Scheduled|VSTs will be infused into stem cell transplant recipients on schedule.
15826733|NCT04230356|Biological|Viral Specific T-cells (VSTs) Treatment|VSTs will be infused into stem cell transplant recipients only if viremia is detected.
15826734|NCT04230343|Behavioral|Self-benefit message|A pamphlet consisting of a short text and an abstract figure. The top half of the pamphlet described the official criteria for qualifying to be in the risk group. Bottom half indicated that one can gain immunity against influenza by getting the vaccine and included a figure of one smiley face.
15826735|NCT04230343|Behavioral|Other-benefit message|A pamphlet consisting of a short text and an abstract figure. The top half of the pamphlet described the official criteria for qualifying to be in the risk group. Bottom half indicated that one can gain immunity against influenza by getting the vaccine, and gaining immunity would lower the chances of transmitting the disease to others. The figure included one smiley face surrounded by three other smiley faces.
15826736|NCT04230330|Drug|IV Nivolumab|240mg every 2 weeks.
15826737|NCT04230330|Drug|IV Nivolumab|Initial treatment dose is 240mg every 2 weeks for 4 doses. Dose changes to 360mg every 3 weeks when given with GDP/L-aspa. Maintenance treatment dose is 240mg every 2 weeks.
15826738|NCT04230330|Drug|IV Gemcitabine|800mg/m2 on Days 1 and 8 every 21 days
15826739|NCT04230330|Drug|IV Cisplatin|20mg/m2 on Day 1 to 4 every 21 days
15826740|NCT04230330|Drug|IV/PO Dexamethasone|10mg on Days 1 to 4 every 21 days
15826741|NCT04230330|Drug|IV L-asparaginase|6000 Units/m2 on Days 2 to 8 every 21 days
15826742|NCT04230317|Diagnostic Test|Chest CT|Low dose CT taken with three different protocols
15826743|NCT04230304|Biological|Daratumumab|Given IV
15826744|NCT04230304|Drug|Ibrutinib|Given PO
15826754|NCT04230239|Drug|CPX-351|"CPX-351 has IV administration Vyxeos contains 2.2 mg/mL and 5 mg/mL powder for concentrate for solution for infusion of Daunorubicin and cytarabine.
~Each vial contains 44 mg of daunorubicin and 100 mg of cytarabine. After reconstitution, the solution contains 2.2 mg/mL daunorubicin and 5 mg/mL cytarabine"
15826755|NCT04230226|Dietary Supplement|Pre-workout plus and protein recovery plus|Study products consumed prior and after exercise
15826756|NCT04230226|Other|Placebo|Placebo product consumed prior and after exercise
15826757|NCT04230213|Drug|PF-06410293|SC injection
15826758|NCT04230213|Drug|adalimumab|SC injection
15826759|NCT04230187|Drug|mFOLFOXIRI plus Bevacizumab|Bevacizumab (5 mg/kg on day 1) plus mFOLFOXIRI (oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) for 8 cycles and followed by bevacizumab and fluoropyrimidine based maintence treatment
15826760|NCT04230187|Drug|mFOLFOX6 Plus Bevacizumab|mFOLFOX6 (oxaliplatin 85 mg/m2, and folinic acid 400 mg/m2 followed by bolus 5-fluorouracil 400 mg/m2 and 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) for 8 cycles and followed by bevacizumab and fluoropyrimidine based maintence treatment
15826761|NCT04230174|Drug|11C-PBR28|This study will evaluate, serially, functional and structural tissue changes in the cortex and WM of subjects with RRMS and progressive disease under Ocrelizumab using 11C-PBR28 MR-PET imaging at baseline and at approximately 12-month follow up.
15826762|NCT04230161|Other|Standard long-lasting insecticidal net|Yahe LN (Yamei Industry) contains a pyrethroid insecticide.
15826763|NCT04230161|Other|Chlorfenapyr insecticide treated net|Interceptor G2® (BASF) is an ITN containing two active ingredients: Alpha-cypermethrin, a pyrethroid insecticide, and chlorfenapyr, a pyrrole insecticide.
15826764|NCT04230161|Other|Indoor residual spraying|Fludora Fusion (Bayer Vector Control) is a spray containing two active ingredients: clothianidin, a neonicotinoid insecticide, and deltamethrin, a pyrethroid insecticide.
15826765|NCT04230148|Drug|Egaten (Triclabendazole) 250 mg tablets|Egaten 250 mg scored tablets for oral use.
15826766|NCT04230135|Device|Hap-pas-Hapi|Hap-pas-Hapi is a Smartphone-based intervention for the treatment of psychological distress. It includes five sessions and uses a narrative approach. Behavioural activation is the main active therapeutic agent in the intervention, along with stress management, positive self-talk, mood tracking, social support, and relapse prevention.
15826767|NCT04230122|Drug|LY3478006 - IV|Administered IV
15826768|NCT04230122|Drug|LY3478006 - SC|Administered SC
15826769|NCT04230122|Drug|Placebo - IV|Administered IV
15826770|NCT04230122|Drug|Placebo - SC|Administered SC
15826773|NCT04230096|Device|low level laser therapy|apply low level laser therapy on buccal surface of maxillary jaw on anterior segment for three minutes at every three weeks in fixed orthodontic patients in their regular follow up visits
15826774|NCT04230083|Drug|Dienogest 2.0 mg Test Drug|Bioequivalence
15826775|NCT04230083|Drug|Dienogest 2.0 mg Reference Product|Bioequivalence
15826776|NCT04230070|Drug|Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Test Drug|Bioequivalence
15826777|NCT04230070|Drug|Levonorgestrel 15.0 mg and Ethinyl estradiol 0.03 mg Reference Product|Bioequivalence
15826778|NCT04230057|Dietary Supplement|Antitumor B|Single dose 2400 mg
15826779|NCT04230044|Drug|Perampanel|Perampanel tablets.
15826780|NCT04230031|Drug|Daratumumab|Experimental
15826781|NCT04229992|Dietary Supplement|Magnesium glycinate|Oral administration of magnesium glycinate daily for 12 weeks
15826782|NCT04229992|Dietary Supplement|Placebo|Oral administration of identical-appearing placebo daily for 12 weeks
15826783|NCT04229979|Biological|Galinpepimut-S|Mixture of four peptides supplied at a concentration of 0.2 mg/vial
15826784|NCT04229979|Drug|Best Available Therapy|"Investigator's choice of 4 options:
~Observation
~HMA (decitabine or azacitidine) monotherapy, or
~Venetoclax monotherapy, or
~Low-dose Ara-C (Drugs in Options #2-4 are given at doses and schedules defined by clinical care guidelines and according to the US Prescribing Information of the respective agents/medications, per standard medical practice)."
15826785|NCT04229953|Device|US scan with 3D/4D VRU software|"Every patient will be evaluated by grayscale 2D-ultrasound and color Doppler. Then, a Samsung WS 80A Elite US scanner with 3D/4D VRU software will be used to assess the placental invasion by applying the two modes (crystal vue and realistic vue). The image analysis will be performed after obtaining the volume dataset. Data will be compared with the intraoperative findings and histopathological confirmation if hysterectomy will be done."
15826786|NCT04229940|Procedure|Peritoneal bridging|The defect is covered by peritoneal bridging
15826787|NCT04229940|Procedure|No peritoneal bridging|The defect is left without bridging
15826788|NCT04229927|Drug|BPDO-1603|"Arm1 : 1 tablet of the test drug, and 1 tablet of placebo reference drug
~Arm2 : 1 tablet of the reference drug, and 1 tablet of placebo test drug"
15826789|NCT04229914|Other|stroke patinets|3-m backwards walk test, timed up and go test, 10 m walk test, Berg BalanceTest, Functional Reach Test
15826790|NCT04229901|Drug|HepaStem|HepaStem will be administered as an intravenous (IV) infusion
15826791|NCT04229901|Drug|Placebo|Placebo will be administered as an intravenous (IV) infusion
15826792|NCT04229888|Device|LipiFlow|Medical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content
15826793|NCT04229888|Device|Light Based Treatment|A light based treatment will be used to compare effectiveness to the LipiFlow treatment.
15826794|NCT04229875|Other|CAG Bipolar|See description of CAG Bipolar
15826795|NCT04229862|Procedure|Laryngeal mask airway insertion|Laryngeal mask airway insertion in patients who undergoing transurethral bladder tumor resection
15826796|NCT04229849|Drug|Anrotenib plus Toripalimab|Anrotenib: 10 mg on day 1-14 orally repeated every 21 days; Toripalimab: 240 mg on day 1 intravenously repeated every 21 days.
15826797|NCT04229849|Drug|Toripalimab|Toripalimab: 240 mg on day 1 intravenously repeated every 21 days.
15826798|NCT04229836|Drug|Tildrakizumab 100 mg Solution for Injection|Participants will be treated with tildrakizumab 100 mg.
15826799|NCT04229823|Diagnostic Test|Video-oculography|Eye movement parameters will be measured in all of the subjects using video-oculography device (EyeSeeCam, InterAcoustics). Measurement sessions consist of the study subject wearing a goggle attached to a camera that detects the pupil and eye position and velocity. Evaluation start with vestibulo-ocular reflex testing, with video head impulse test. Afterwards, saccades, smooth pursuit and fixation are evaluated.
15826800|NCT04229823|Diagnostic Test|Clinical Scales|All subjects are examined by an investigator in order to score clinical scales for ataxia, including Scale for the Assessment and Rating of Ataxia (SARA), International Co-operative Rating Scale (ICARS), Neurological Examination Scale for SCA (NESSCA), Inventory of Non-ataxia Symptoms (INAS), SCA Functional Index (SCAFI) and Composite Cerebellar Functional Severity Score (CCFS).
15826801|NCT04229823|Diagnostic Test|Genotyping|Individuals at 50% risk (offspring of subjects with molecular diagnosis of SCA3/MJD) will be genotyped in a double-blind manner so that they can be divided into pre-ataxic carriers and related controls (non carriers)
15826802|NCT04229810|Procedure|STD-02|Conventional standardized ventilatory approach.
15826803|NCT04229810|Procedure|iOLA-iHFNC|Indivudualized perioperative open lung ventilatory approach.
15826804|NCT04229797|Procedure|Mandibular distalization using extra-radicular miniscrews|Distalization of the Mandibular first molars using mandibular buccal shelf mini-screws in the presence of unerupted third molars
15826805|NCT04229784|Procedure|Radiofrewuency surgery|The research procedure consists of radiofrequency destruction of hemorrhoidal vascular tissue. It consists in delivering a 4 MHz radiofrequency wave current delivered at low temperature by microfibre electrodes using a large disposable needle within the hemorrhoidal vascular tissue
15826806|NCT04229771|Drug|Proparacaine Hydrochloride ophthalmic solution, USP 0.5%|One drop instilled in one eye, randomly chosen, as topical anesthetic
15826807|NCT04229771|Drug|Balanced salt solution|One drop instilled in one eye, randomly chosen, as control placebo
15826808|NCT04229758|Drug|Anticoagulants|DOAC for the prevention of thromboembolic events in patients with non-valvular AF or VTE.
15826809|NCT04229745|Device|THRIVE pre-oxygenation|Clinical Trial of Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (THRIVE) Oxygen in Women having Planned Caesarean Delivery
15826810|NCT04229732|Device|ClearMateTM|Passive isocapnic hyperventilation breathing circuit.
15826811|NCT04229719|Drug|N-acetyl-5-methoxytryptamine|1.2 mg of melatonin powder will place in the osteotomy site before the insertion of the implant.
15826812|NCT04229706|Drug|xingjurupining capsule|xingjurupining capsule,8 capsule,tid,3 months.
15826813|NCT04229706|Drug|xiangjurupining capsule, xiangjurupining capsule placebo|xiangjurupining capsule,4 capsules , and xiangjurupining capsule placebo,4 capsules,tid,3 months.
15826814|NCT04229706|Drug|xiangjurupining capsule placebo|xiangjurupining capsule,8 capsule,tid,3 months.
15826815|NCT04229693|Other|no intervention|no intervention, only observational.
15826816|NCT04229680|Other|High Salt|Consumption of pills containing table salt for 10 days.
15826817|NCT04229680|Other|Recommended Salt|Consumption of pills containing dextrose for 10 days.
15826818|NCT04229667|Other|Improved Community Health Volunteer (CHV) program|"Multi-modal intervention targeting intensive household monitoring of high-needs patients using monthly visits to measure blood pressure and blood sugar, adherence to treatments and compliance with clinics visits, and motivational interviewing to facilitate behavior change and psychosocial support."
15826819|NCT04229654|Other|Questionnaire|A written questionnaire was used to capture demographic data, obstetric history, knowledge, expectations, and perception of anomaly scans.
15826820|NCT04229628|Other|No special intervention|No special intervention
15826821|NCT04229615|Drug|Fluzoparib; Apatinib|Drug: Fluzoparib Orally twice daily; Apatinib Orally once daily
15826822|NCT04229615|Drug|Fluzoparib|Fluzoparib Orally twice daily
15826823|NCT04229615|Drug|Placebo|Placebo
15826824|NCT04229602|Drug|Venlafaxine Hydrochloride Sustained-Release Capsules 75 mg|A generic product manufactured by Beijing Winsunny Pharmaceutical Co., Ltd.
15826825|NCT04229602|Drug|EFEXOR® XR|EFEXOR® XR (75mg) produced by Pfizer Ireland Pharmaceuticals(held by Pfizer Healthcare Ireland, distributed by Wyeth pharmaceutical co. LTD)
15826826|NCT04229589|Other|Clinic follow-up|Patients are regularly evaluated to asses the occurrence of syncopal relapses
15826827|NCT04229576|Device|TENs|Assessing the efficacy of TENs in pain relieve during office hysteroscopy .
15826828|NCT04229563|Device|AURYON™ System|"The AURYON™ System consists of two sub-units: 1) a single use catheter (AURYON™ catheter); and 2) a laser system."
15826829|NCT04229550|Behavioral|Festival participation|One week's participation in Roskilde Festival 2016 or living a normal daily life.
15826830|NCT04229537|Biological|SCT-I10A|200 mg intravenous (IV) on Day 1 of Q3W.
15826831|NCT04229537|Biological|SCT200|6mg/kg intravenous (IV) on Day 1 of QW, then 8mg/kg intravenous (IV) on Day 1 of Q2W
15826832|NCT04229537|Other|Chemotherapy|Capecitabine and Oxaliplatin.
15826833|NCT04229524|Procedure|Fluorescence angiography|After the tube and stomach were made during surgery, the predetermined anastomosis position was marked with sutures in advance according to the doctor's experience, and then 0.04ml / kg indocyanine green injection was injected into the central vein. Next, dynamic observation and recording of the tube-gastric anastomosis area in 136 seconds using a fluorescent imaging system with a fixed focal length till the fluorescence reaching range and intensity. If the average value of the fluorescence value of the anastomosis position is greater than 30, then the anastomosis position may be according to the original plan or moved to the proximal part. If the average fluorescence value of the predetermined anastomosis position is less than 30, the anastomosis must move to proximal part ensure anastomosis with fluorescence value at least> 30.
15826834|NCT04229511|Diagnostic Test|Detection of CRKp colonization|Detection of CRKp colonization will be performed in all participants by sceening with rectal swab
15826835|NCT04229498|Drug|Monotherapy and combination therapy (all antibiotics that are given by attending pysicians and can be active against Klebsiella pneumoniae will be evaluated)|In carbapenem heteroresistant Klebsiella pneumoniae group, carbapenem monotherapy (ertapenem, imipenem, meropenem) vs other treatment groups will also be compared
15826836|NCT04229472|Diagnostic Test|High density electrophysiological mapping|Recording of electrophysiological data using a high density contact catheter during pacing at the time of catheter ablation for atrial fibrillation.
15826838|NCT04229459|Drug|Cisplatin|Cisplatin 100mg/m2 IV on day 1 of induction chemotherapy, 75mg/m2 IV on day 1 and 29 of chemoradiation
15826839|NCT04229459|Drug|5-FU|5-FU 1000mg/m2/d IV on days 1-5 of induction chemotherapy, 1000mg/m2/d IV on days 1-4 and days 29-32 of chemoradiation
15826840|NCT04229459|Radiation|Radiation therapy|1.8 Gy/fraction, 5 days a week for a total of 28 days
15826841|NCT04229459|Drug|Cetuximab|Cetuximab 400mg/m2 IV on day 1 followed by 250mg/m2 IV weekly on induction chemotherapy, 250mg/m2 IV weekly on chemoradiation, 500mg/m2 IV on day 1 of each treatment cycle, every two weeks during immunotherapy
15826842|NCT04229459|Drug|Nivolumab|Nivolumab 3mg/kg IV on day 1 of each treatment cycle, every two weeks during immunotherapy
15826843|NCT04229446|Behavioral|Music based caregiving|The intervention (MBC) consists of daily individualized prerecorded music integrated with activity with about 30 minutes duration, combined with a one hour active session in groups twice weekly. The music will be selected based on individualized preferences from the patients or their family. The music will also be adapted to the day rhythm; awakening in the morning, support activities during the day, or for sleep in the evening. The healthcare worker will bring playback equipment e.g. a CD-player to the patient room. In addition will two weekly sessions in groups be performed (each on one hour) with music and movement.
15826844|NCT04229433|Drug|SHR2285 tablet|Pharmaceutical form: SHR2285 tablet Route of administration: single dose and multiple doses.
15826845|NCT04229433|Drug|Placebo|Pharmaceutical form: Placebo tablet Route of administration: single dose and multiple doses.
15826846|NCT04229420|Device|Ultrasound guided Rectus sheath block vs Erector spinae plane block|Ultrasound guided Rectus sheath block vs Erector spinae plane block
15826847|NCT04229407|Dietary Supplement|Dietary supplement|MRI eligibility evaluation Dietary supplement drink powder dissolved in 150 c.c. warm water oral intake twice daily at every morning and night (30 minutes after exercise if do exercise) for 12 weeks subjects will be instructed to do 45-minute exercise once a week following the training program of the study trainer at gym, and 30-minute exercise (per exercise manual) at least twice a week at home.
15826848|NCT04229407|Dietary Supplement|vitamin B|MRI eligibility evaluation vitamin B drink powder dissolved in 150 c.c. warm water oral intake twice daily at every morning and night (30 minutes after exercise if do exercise)for 12 weeks subjects will be instructed to do 45-minute exercise once a week following the training program of the study trainer at gym, and 30-minute exercise (per exercise manual) at least twice a week at home.
15826849|NCT04229394|Drug|2ccPA|"Four dose cohorts (50 μg, 200 μg, 800 μg, and 2,400 μg) are planned in this study sequentially.
~study group: one dose intra-articular on day1"
15826850|NCT04229394|Drug|placebo|"A total of 8 subjects will be recruited and randomized in each dose cohort with a 3:1 ratio (6 subjects in the 2ccPA treatment arm and 2 subjects in the placebo arm).
~control group: one dose intra-articular on day 1"
15826851|NCT04229381|Procedure|Physical Therapy|Undergo physical therapy
15826852|NCT04229381|Other|Quality-of-Life Assessment|Ancillary studies
15826853|NCT04229381|Other|Questionnaire Administration|Ancillary studies
15826854|NCT04229381|Procedure|Relaxation Therapy|Undergo progressive muscle relaxation
15826855|NCT04229368|Dietary Supplement|Vitamin D3|Vitamin D will be given at doses commonly given to patients with low vitamin D levels
15826856|NCT04229355|Drug|DEB-TACE plus Sorafenib|Drug-eluting bead transarterial chemoembolization plus sorafenib (400 mg/d, po, bid)
15826857|NCT04229355|Drug|DEB-TACE plus Lenvatinib|Drug-eluting bead transarterial chemoembolization plus lenvatinib (8 mg/d, po, qd)
15826858|NCT04229355|Drug|DEB-TACE plus PD-1 inhibitor|Drug-eluting bead transarterial chemoembolization plus PD-1 inhibitor
15826859|NCT04229342|Procedure|Per-oral endoscopic myotomy|"Per-oral endoscopic myotomy (POEM) is an endoscopic modality for the management of achalasia cardia. In this study, we will evaluate the impact of two different techniques of posterior POEM on the incidence of gastroesophageal reflux disease (GERD).
~Posterior POEM will be performed using the standard technique. The myotomy beyond the GEJ will be different in the two groups. In one group, the sling fibers will not be spared from dissection and in the second group, the sling fibers will be selectively spared from myotomy."
15826860|NCT04229329|Combination Product|Intensive Finger Individuation Therapy|Interactive robot-mediated treatment aimed at increased individuation done repeatedly for at least1 hour per day for 2 weeks (5 training days a week).
15826861|NCT04229329|Combination Product|Intensive non-directed finger movement therapy|Interactive robot-mediated treatment not aimed specifically at increased individuation done repeatedly for at least 1 hour per day for 2 weeks (5 training days per week)
15826862|NCT04229316|Device|zLOCK Facet Stabilization System|zLOCK Facet Stabilization System is a device intended to provide posterior stability in lumbar spine in order to reduce lumbar back pains
15826863|NCT04229303|Drug|Voriconazole inhaled (ZP-059)|Part 1 is a single ascending dose (SAD) study; Part 2 is a multiple ascending dose (MAD) study.
15826864|NCT04229303|Drug|Cross-over with VFEND|Part 3 is a 2-period, randomised, crossover study of single doses of ZP-059 compared to single doses of VFEND
15826865|NCT04229290|Drug|Dolutegravir|Switch of virally suppressed participants to Dolutegravir
15826866|NCT04229277|Diagnostic Test|optical coherence tomography|comparison of four imaging technologies in skin tumour diagnosis
15826867|NCT04229264|Drug|Apixaban|Oral Apixaban 2.5 mg twice daily for one year
15826868|NCT04229264|Drug|ASA|Acetil Salicilic Acid 100mg once daily for one year
15826869|NCT04229264|Drug|Clopidogrel 75mg|Clopidogrel 75mg once daily for 3 months
15826870|NCT04229251|Behavioral|Online Mindfulness-based Intervention|The iMBI starts with psychoeducation about ADHD and defining mindfulness. Participants were then encouraged to discuss their experience of living with ADHD via a series of guided questions. Upon orientated to the program, the participants will be introduced to various topics of mindfulness and ADHD, as well as a wide range of in-session online mindfulness exercises. Offline assignments that correspond to each week's theme will be assigned to participants at the end of each session. Downloadable audio tracks for offline practices will be provided to the participants. Participants are expected to spend around 15 to 30 minutes each day to complete the weekly iMBI assignment.
15826930|NCT04228809|Device|tDCS|transcranial direct current stimulation
15826871|NCT04229251|Behavioral|Online Introductory Psychology Program|The online introductory psychology program is a mass online open course program, providing comprehensive overview about psychology as an academic discipline. Each week, participants will be presented with approximately 2-hours pre-recorded lecture. Offline assignments that correspond to each week's theme will be assigned to participants at the end of each session.Downloadable handouts for revision will be provided to the participants. Participants are encouraged to spend around 15 to 30 minutes each day to complete the weekly assignment.
15826872|NCT04229225|Drug|UBX0101|Investigational drug intra-articular (IA) injection
15826873|NCT04229225|Other|Placebo|Placebo intra-articular (IA) injection
15826874|NCT04229212|Device|hemovac drain (Zimmer Biomet, Autotransfusion System [HAS], United State)|In the drained group, a hemovac drain (Zimmer Biomet, Autotransfusion System [HAS], United State) was placed beneath the fascia of the gluteus muscle, surrounding the entry point of the nail at the fracture site.
15826875|NCT04229199|Behavioral|simulation|Dyads allocated to the IG were taken into a tour to a simulation operating room accompanied by an expert anesthesia technologist two weeks before the day of surgery. This simulation operating theater is a real operating room equipped with a surgical trolley, sealing surgical lights, anesthesia machine, vital signs monitor, stethoscope, surgical trays, surgical sink, and gas supply pendent. It was prepared with popular cartoon characters, child manikin, and face masks connected to the anesthesia circuit and re-breathing bag. After being assessed by anesthesia clinic doctors, children and their parents in the IG were given a chance to visit the simulation operating room, to receive orientation, education, and demonstration orientation about what they are going to experience in the operating room. Children were encouraged to apply vital signs monitoring, and to simulate providing mask anesthesia induction to a child manikin.
15826876|NCT04229186|Dietary Supplement|EVOO-C|Each patient will consume 10 mg total daily amount EVOO-C
15826877|NCT04229186|Dietary Supplement|ROO|Each patient will consume 10 mg total daily amount ROO
15826878|NCT04229173|Diagnostic Test|MRI acquisition|MRI acquisition
15826879|NCT04229173|Diagnostic Test|DAT-SPECT|Imaging with DAT SPECT (Dopamine Transporter, Single Photon Emission Computed Tomography)
15826880|NCT04229173|Diagnostic Test|blood sample, cerebrospinal fluid (optional)|blood sample, cerebrospinal fluid
15826881|NCT04229173|Behavioral|Evaluations about motor abilities, depression, cognition and lifestyle|Evaluations about motor abilities (UMSAR scale), depression (BDI scale), cognition (MoCA scale) and lifestyle (MSA- QoL)
15826882|NCT04229173|Behavioral|Evaluation about depression cognition|Evaluations about depression (BDI scale), cognition (MoCA scale)
15826883|NCT04229160|Device|Noninvasive mapping (Cardioinsight® system)|Noninvasive mapping (Cardioinsight® system) of the left atria before the Atrial fibrilation ablation procedure
15826884|NCT04229160|Device|long-term cardiac monitoring (LINQ system)|long-term cardiac monitoring (LINQ system) is used to evaluate recurrence rate following AF ablation procedure
15826885|NCT04229160|Procedure|Atrial Fibrillation ablation procedure|Atrial Fibrillation ablation procedure is done with standard practice
15826886|NCT04229147|Radiation|Radiotherapy|Patients who received a total dose of 30 Gy
15826887|NCT04229134|Behavioral|Project CONNECT|Home based pain self-management intervention using peer reinforcement to promote engagement and skill uptake
15826888|NCT04229121|Other|nonintervention|nonintervention
15826889|NCT04229108|Device|Medopad|Timed up and go module of Medopad application. About page explains how to perform test and conditions, subsequent page contains timer, once completed test, commence on final page which has a number of short questions to complete
15826892|NCT04229082|Other|observational|
15826893|NCT04229069|Dietary Supplement|alkaline salt mixture|blood and tissue alkalinisation
15826894|NCT04229069|Dietary Supplement|placebo|no blood and tissue alkalinisation
15826895|NCT04229056|Behavioral|Computer-based cognitive rehabilitation (CBCR)|CBCR are software-programmes for computers which are clinically developed for rehabilitation of various cognitive functions.
15826896|NCT04229056|Behavioral|General computer-based cognitive stimulation|For this trial we have developed a webpage for cognitive sham-training, which is designed to provide general computer-based cognitive stimulation.
15826897|NCT04229043|Dietary Supplement|Sports drink|Drink that will be ingested
15826898|NCT04229043|Dietary Supplement|Water|Drink that will be ingested
15826899|NCT04229030|Drug|RZL-012|small synthetic molecule for the treatment of Dercum's Disease lipomas
15826900|NCT04229030|Drug|Vehicle|Vehicle of RZL-012 drug product
15826901|NCT04229017|Procedure|Anterior Cervical Discectomy and Fusion|Anterior Cervical Decompression and Fusion (ACDF) is a standard of care procedure that is performed using standard instruments and completed with an allograft interbody implant and anterior plate.
15826902|NCT04229017|Device|Posterior Cervical Stabilization System (PCSS)|Posterior Cervical Stabilization System (PCSS) is non-segmental instrumentation with integrated screw fixation intended to provide immobilization and stabilization of spinal segments. PCSS achieves bilateral facet fixation by spanning the interspace at each level with points of fixation at each end of the construct.
15826903|NCT04229004|Drug|Gemcitabine combined with nab-paclitaxel|"Nab-paclitaxel is infused over 30-40 min on days 1, 8, 15 of each 28-day cycle. Gemcitabine is infused over 30 min, immediately after completion of nab-paclitaxel infusion, on days 1, 8, 15 of each 28-day cycle If one of the chemotherapy medications is held, the other study medications may be given.
~Doses should be re-adjusted if the subject's BSA changes by +/- >10%. If the subject's BSA changes by <10%, no adjustment is necessary unless the site has a standard procedure to adjust doses based upon current BSA according to institutional guidelines."
15826904|NCT04229004|Drug|Dose -SM-88|460 mg (2 capsules) twice daily of a 28-day cycle along with the administration of methoxsalen, phenytoin and sirolimus.
15826905|NCT04229004|Drug|Dose -mFOLFIRINOX|The following are recommended parameters for infusion timing and sequence, although institutional variation in the administration of the regimen are permitted, as long as drug dosing and modification guidelines are followed. Oxaliplatin and leucovorin are administered concurrently over 30-120 minutes, followed by irinotecan over 30-90 minutes, followed by the infusion of 5-flurouracil. If one of the chemotherapy medications is held, the other study medications may be given. Doses should be re-adjusted if the subject's BSA changes by +/- >10%. If the subject's BSA changes by <10%, no adjustment is necessary unless the site has a standard procedure to adjust doses based upon current BSA according to institutional guidelines.
15826906|NCT04229004|Drug|Dose|"Pamrevlumab 35mg/kg IV - Day 1, 15 with an additional dose on Day 8 of Cycle 1 only
~Nab-paclitaxel 125mg/m2 IV - Day 1, 8, 15
~Gemcitabine 1000mg/m2 IV - Day 1, 8, 15"
15826907|NCT04228991|Radiation|Locoregional radiation treatment - Conventional fractionation|40 Gray in 15 daily fractions over 3 weeks
15826908|NCT04228991|Radiation|Locoregional radiation treatment - Hypofractionation|26 Gray in 5 daily fractions over 1 week
15826909|NCT04228978|Behavioral|Weight loss|Walking exercise combined with weight loss
15826910|NCT04228978|Behavioral|Exercise|Walking exercise
15826911|NCT04228965|Drug|Varenicline|Varenicline is a medication approved by the Food and Drug Administration for the treatment of tobacco use disorder among adults (ages 18 and over). In this study, all participants will be administered active medication for the recommended 12 week treatment period. The standard dose titration schedule will be used, which includes 0.5 mg once per day (q.d.) on Days 1-3, 0.5 mg twice per day (b.i.d.) on Days 4-7, and 1.0 mg b.i.d. starting on Day 8. Dosing of 2.0 mg per day will be maintained for the next 11 weeks, for a total of 12 weeks of active treatment for all study participants.
15826912|NCT04228965|Behavioral|Contingency Management|Contingency management procedures will be implemented and financial incentives will be provided at weekly visits contingent on tobacco abstinence verified through urinary qualitative cotinine (starting at Week 2). A set amount of $20 per study visit will be delivered based on a negative qualitative urinary cotinine result.
15826913|NCT04228965|Behavioral|Counseling|Psychosocial counseling will be administered by trained research staff leading up to the target quit date and throughout the study. Counseling will include motivational enhancement for medication adherence and tobacco cessation. The content of counseling will be skills-based and will focus on enlisting social support, recognizing smoking triggers, managing craving/withdrawal/stress, etc.
15826914|NCT04228952|Combination Product|Modified Natural American Spirit-Tan or Green cigarettes injected with labeled NNK|American Spirit cigarettes will be modified by adding 0.300 μg [pyridine-D4]NNK to each cigarette so that the amount of total (deuterated plus unlabeled) NNK in these cigarettes is below 0.700 μg/g tobacco.
15826915|NCT04228939|Behavioral|Recovery Record aftercare|"Patients randomized to IG receive a therapist-guided smartphone-based aftercare intervention for a period of 16 weeks. The patients are invited to download for free the German version of Recovery Record at the App Store (iPhone) or the Google Play Store (android) to their smartphone and to link with the aftercare therapist. After discharge, patients are asked to monitor their meals at least three times per day (breakfast, lunch, and dinner), that is, to produce a minimum of three logs per day over the subsequent 16 weeks. Furthermore, patients are instructed to monitor their thoughts and feelings as well as their (disordered) behaviors. The aftercare therapist also sets the patients clinical post-discharge goals and makes coping skill suggestions. Individual therapist feedback is provided in-app twice per week during the first four weeks, once per week in weeks 4-8, every other week in weeks 8-12 and once in week 16."
15826916|NCT04228939|Behavioral|Treatment as usual (TAU)|Patients randomized to CG receive TAU i.e. patients and their physicians or therapists decide on post-discharge treatment which is documented at T1 and T2.
15826917|NCT04228926|Drug|ZKY001 eye drops 0.3g:0.006mg|ZKY001 eye drops of 0.002% continuously for up to 14±2 days after Corneal endothelial transplantation
15826918|NCT04228926|Drug|ZKY001 eye drops 0.3g:0.012mg|ZKY001 eye drops of 0.004% continuously for up to 14±2 days after Corneal endothelial transplantation
15826919|NCT04228926|Drug|ZKY001 simulated eye drops|ZKY001 simulated eye drops continuously for up to 14±2 days after Corneal endothelial transplantation
15826920|NCT04228913|Other|Root Canal Obturation Technique|This study aims to compare the effects of three different obturation techniques(cold lateral condensation,thermoplasticized solid-core carrier method, cold free flow compaction technique) on postoperative pain following the endodontic therapy
15826921|NCT04228900|Dietary Supplement|Individualized plan for improvement of nutrition|For each participant we will make a plan, describing different items the can improve their nutritional status: enrichment of food, dental care,
15826922|NCT04228900|Drug|Systematic drug review|Consider altering medication list if the patient has symptoms that may be attributed to adverse drug effects, in particular side effects as nausea, dry mouth or loss of appetite, and if drug-drug interactions or drug-disease interactions are likely to occur. Recommended changes in patient's medication list will be presented for the family physician who will hold the final decision to implement the suggested adjustments.
15826923|NCT04228887|Diagnostic Test|Respiratory Muscle Strength|Respiratory muscle strengths will evalueted with inspiratory and expiratory mouth pressure devices.
15826924|NCT04228887|Device|Balance Training|Balance training will provide with Biodex® Balance Training System
15826925|NCT04228887|Device|Inspiratory Muscle Training|15 minutes twice a day, 5 times a week for 8 week with Threshold IMT device
15826926|NCT04228874|Device|coronary artery stents|"Coronary angiography was done for all the patients according to the Judkins technique. All images were evaluated by an experienced operator, significant coronary artery disease was defined as > 70 % luminar diameter stenos. The following data was obtained:
~Site of stent implantation within LAD. The first Diagonal branch serves as the boundary between the proximal and mid portion of the LAD. Thus, the portion of the artery prior to the origin of the 1st diagonal is known as the proximal LAD, while the segment just below the1st diagonal branch is the mid LAD. The distal segment of the LAD is the terminal third of the artery (Cao et al., 2017).
~Length, diameter and number of stents.
~TIMI flow after stent deployment."
15826927|NCT04228848|Other|new triple hop test|New jumping assessment will be performed in all included study groups. This new assessment includes quality evaluation.
15826928|NCT04228835|Diagnostic Test|Fluorescence Cholangiography|Administration of ICG for fluorescence cholangiography
15826929|NCT04228822|Other|Low carbohydrate diet|25-35% of carbohydrates from total energy intake
15826934|NCT04228770|Behavioral|Meeting with pharmacist|Meeting with pharmacist to support drug management following their routine surgery.
15826935|NCT04228757|Dietary Supplement|phytoestrogen herbal blend|phytoestrogen herbal blend
15826936|NCT04228757|Other|Placebo|Tablet without active ingredients
15826937|NCT04228744|Device|DBS system|"The DBS device utilized in the present study includes a dual-channel neurostimulator kit, lead kit, extension kit, clinician-operated wireless programmer, test stimulator, and patient controller. The lead contains four stimulating contacts. The length of each contact is 1.5 mm, and the spacing between contacts is 1.5 mm.
~The participants will receive stepwise surgery. The electrodes will be implanted firstly which will be externalized for several days and then the IPG will be implanted. During externalization, the experimenters will record the local field potential and electroencephalography in resting or task-based state with conditions of sham-stimulation or active-stimulation."
15826940|NCT04228718|Behavioral|Zarit Burden Interview Scale|It is a questionnaire consisting of 22 items. A minimum score of 0 and a maximum score of 88 can be obtained. The higher the scale score, the higher the difficulty experienced.
15826941|NCT04228718|Behavioral|Family Needs Survey (FNS)|It is a questionnaire consisting of 35 items prepared to determine the requirements. In the FNS survey; The points given to the items can be directly collected and the amount of family needs can be determined over the total score. The lowest score that can be obtained from FNS is 29 and the highest score is 87. As the scores obtained from the scale and subscales increase, it can be said that the families' level of necessity increases.
15826942|NCT04228718|Other|Children's Hospital of Philadelphia Infant Test of Neuromuscular Disorders (CHOP INTEND)|CHOP-INTEND uses a scale of 0-64 points. Higher scores indicate better motor function. It is used to reliably measure natural motor function decline in infants with SMA Type 1.
15826943|NCT04228718|Other|Hammersmith Functional Motor Scale Expanded (HMFSE)|It is an extended version of the 20-item HFMS. Based on another scale known as GMFM, 13 items were added and expanded HFMS to include these elements. Therefore, HFMSE is a scale used to evaluate motor functions in types 2 and 3 SMA. It contains 33 items with a total score of 66 on a scale of 0, 1, 2.
15826944|NCT04228692|Procedure|Self-catheterization only|Patients self-catheterized after each micturition, noting the volume of each spontaneous micturition as well as the volume obtained by subsequent self-catheterization, until self-catheterization is no longer necessary.
15826945|NCT04228692|Device|Posterior tibial nerve stimulation + self-catheterization|"Patients self-catheterized after each micturition, noting the volume of each spontaneous micturition as well as the volume obtained by subsequent self-catheterization, until self-catheterization is no longer necessary.
~Patients will have 2 sessions per day of PTN (10-20 min) until self-catheterization is no longer necessary."
15826946|NCT04228679|Device|Erbium laser|Erbium laser device
15826947|NCT04228679|Device|Sham Laser|Sham laser device
15826948|NCT04228666|Biological|HB-adMSCs|Four IV infusions of autologous adipose-derived mesenchymal stem cells. Baseline laboratory data will be collected prior to first infusion; follow-up data will be compared against baseline according to the following schedule: safety laboratory tests follow-up on weeks 4, 8, 13, 26, and 52; inflammation and amyloid markers follow-up on weeks 13 and 52; MMSE and ADCS-ADL follow-up on weeks 13, 19, 26, 33, 40, 46 and 52; Altoida NMI follow-up will occur weekly from week 0 to week 52; CDR follow-up will occur weeks 4, 10, 13, 19, 26, 33, 40, 46 and 52; C-SSRS follow-up will occur on weeks 4, 10, 26, and 52; Amyloid PET imaging follow-up occurs week 26 and 52;
15826949|NCT04228653|Device|Renishaw Drug Delivery System|Device that allows pharmaceuticals to be delivered into the brain is to be assessed over a period of time to inform of the long term safety of the implanted device.
15826950|NCT04228640|Other|NMN|Investigational Product
15826951|NCT04228640|Other|Placebo|Starch Powder
15826952|NCT04228627|Drug|Parentral Iron|Correction of Iron stores without anaemia
15826953|NCT04228601|Drug|Fluzoparib|PARP
15826954|NCT04228601|Drug|Fluzoparib placebo|Placebo
15826955|NCT04228601|Drug|mFOLFIRINOX|mFOLFIRINOX
15826956|NCT04228588|Drug|Mepolizumab 100 MG [Nucala]|Mepolizumab 100mg, SC, every 4 weeks
15826957|NCT04228575|Behavioral|Internet-delivered cognitive behaviour therapy|All clients will receive the Wellbeing Course developed at Macquarie University, Australia. The Wellbeing Course is a transdiagnostic Internet-delivered cognitive behaviour intervention targeting symptoms of depressive and anxiety disorders. It comprises 5 online lessons targeting: 1) symptom identification and the cognitive behavioural model; 2) thought monitoring and challenging; 3) de-arousal strategies and pleasant activity scheduling; 4) graduated exposure; and 5) relapse prevention. Materials are presented in a didactic (i.e., text-based with visual images) and case-enhanced learning format (i.e., educational stories demonstrate the application of skills) and include homework activities. Lessons are released gradually in a standardized order over 8 weeks. Phone calls will only be made if there is a significant clinical issue requiring therapist attention that cannot be addressed over email (e.g., sudden increase in symptoms). Therapists will spend ~15 mins. per week/per client.
15826958|NCT04228562|Other|non-modifiable factor|the presence of an uncontrollable / unremovable risk factor for a disease
15826959|NCT04228562|Other|induction of anticipated regret|higher level of elaboration on potential regret
15826960|NCT04228549|Device|MyPADMGT|Online tracking and feedback to help patients adopt healthy lifestyles
15826961|NCT04228549|Device|MyPADMGT + Nudging|Online tracking and feedback to help patients adopt healthy lifestyles plus nudging support to assist in making decisions
15826962|NCT04228536|Procedure|Totally ExtraPeritoneal (TEP) repair|
15826963|NCT04228536|Procedure|TransAbdominal PrePeritoneal (TAPP) repair|
15826964|NCT04228536|Procedure|Open anterior mesh repair (OAM)|
15826965|NCT04228536|Procedure|Combined Anterior and Posterior technique (CAP)|
15826966|NCT04228536|Procedure|Open PrePeritoneal Mesh technique (OPPM)|
15826967|NCT04228536|Procedure|Sutured Repair|
15827060|NCT04227821|Other|Vasopressor and/inotrope therapy|In pediatric patients admitted to the pediatric intensive care, with the persistent hemodynamic instability after fluid resuscitation, the vasopressor and/or inotrope therapy will be initiated
15826968|NCT04228523|Other|Therapeutic education workshop|"Workshop on Parkinson disease drug has several educative sequences (lasting 4hours).
~A first round table is organized to know the needs and issues related to drug management of patients.
~The 1st educative sequence consists in knowing the different class of dopaminergic drugs and their action.
~The 2nd educative sequence leads patients to understand their prescription and be aware of the needs to take pills regularly.
~The 3rd educative sequence consists in learning and identifying potentials adverse effects and finds effective strategies to prevent them.
~At the end, one patient explains its tips and tricks about its drug management"
15826969|NCT04228523|Other|Speaking Therapy|Speaking group is leaded by a psychologist from Centre Expert Parkinson (lasting 2 hours). This specific time is an exchange between patients with Parkinson disease who feel free to come. It is about sharing its own experience. It is a very special moment, confidential and kindly where patients don't judge themselves and speak only if they want to.
15826970|NCT04228510|Procedure|2D speckle tracking echocardiography|"Global and segmental strain and strain rate in longitudinal and circumferential directions will be detected after PPCI; before discharge. The LV circumferential strains and strain rates will be determined from the short-axis views at the basal, middle, and apical levels, and longitudinal strains and strain rates will be determined from the apical 2-, 3-, and 4-chamber views of the LV.
~Segmental longitudinal strains equal to -15% or closer to 0 will be considered abnormal (injured segments). The average segmental longitudinal strain and strain rate of the abnormal segments is defined as the injury longitudinal strain (InjLS) and injury longitudinal systolic strain rate (InjLSRs)."
15826971|NCT04228497|Device|gastric ultrasound|Children in both groups will be scanned in two positions: supine position and right lateral position (RLP) one and two hours following the clear fluid intake and before admission to the operation room in groups 1 and 2 respectively. Gastric antrum will be located in the sagittal plane with simultaneous identification of left lobe of the liver and the descending abdominal aorta or inferior vena cava.
15826972|NCT04228497|Other|the clear fluid intake|the clear fluid intake
15826973|NCT04228484|Other|Placebo|Placebo infusion
15826974|NCT04228484|Other|GIP receptor antagonization|GIP(3-30)NH2 infusion
15826975|NCT04228471|Procedure|spontaneous breathing activity during APRV|Allowing spontaneous breathing activity with APRV throughout the first 48 hours.
15826976|NCT04228471|Procedure|No spontaneous breathing activity|No spontaneous breathing activity will be allowed with pressure controlled ventilation throughout the first 48 hours.
15826977|NCT04228458|Device|Thermal Imaging|Testing the effectiveness of using a Thermal Imaging camera in participants with Juvenile Arthritis.
15826978|NCT04228445|Drug|3,3'-Dioxo-2,2'-bisindolylidene-5,5'-disulfonate disodium 0.8%|Experimental contrast dye that is commonly used as a visualization aid in pelvic and abdominal surgeries and for various diagnostic procedures in medical practice.
15826979|NCT04228445|Drug|Saline spray|Placebo
15826980|NCT04228432|Other|Dedicated and coordinated monitoring|"Coordinated monitoring performed by a dedicated nurse: consultation before hormonotherapy initiation
~Monitoring at home over a period of 6 months using an e-monitoring tool: assessment of adverse events and completion of GIRERD questionnaire at week 3 and week 6."
15826981|NCT04228419|Procedure|Total Shoulder Arthroplasty|TSA procedure involves replacing the worn-out ball and socket joint with prosthetic components.
15826982|NCT04228419|Procedure|Reverse Shoulder Arthroplasty|RSA procedure is similar to a TSA, however the orientation of the ball and socket joint is placed in the reverse position.
15826983|NCT04228419|Procedure|Total Shoulder Arthroplasty + Augmented Glenoid Implantation|"Patients who present with a more severe amount of bone loss, will undergo a standard TSA and also have additional modified prosthetic, known as augmented glenoid component implant inserted to make up for the amount of bone loss and greater degree of glenoid retroversion."
15826984|NCT04228406|Drug|GST-HG161|There are 7 dose cohorts, including60mg, 150mg, 300mg, 450mg, 600mg, 750mg, 900mg QD in the dose escalation stage and GST-HG161 will be administered orally to patients once daily for each dose cohort. Recommended dose in the dose expansion stage will be determined by the results in the dose escalation stage .
15826985|NCT04228393|Drug|6-mercaptopurine|6-mercaptopurine was administered orally to patients once daily.
15826986|NCT04228393|Procedure|Standard treatment|The initial dose is 50mg/m2. The dose was adjusted according to white blood cells.
15826987|NCT04228393|Procedure|Individualized treatment|The initial dose is determined according to the genotypes of patients combined with Clinical Pharmacogenetics Implementation Consortium (CPIC). The dose was adjusted according to white blood cells, genotypes and the concentrations of 6-TGN in red blood cells.
15826988|NCT04228380|Other|No intervention|No intervention
15826990|NCT04228354|Drug|Semaglutide|Two doses of semaglutide given by subcutaneous (s.c., under the skin) injection with different drug product concentration and separated by 6 to 8 weeks
15826991|NCT04228341|Other|Glucose Reference 1|50 g of glucose dissolved in 250 ml of water (First glucose control visit)
15826992|NCT04228341|Other|Glucose Reference 2|50 g of glucose dissolved in 250 ml of water (Second glucose control visit)
15826993|NCT04228341|Other|Glucose Reference 3|50 g of glucose dissolved in 250 ml of water (Third glucose control visit)
15826994|NCT04228341|Other|Brown Rice|Unpolished brown rice containing 50 g of available carbohydrate was cooked using a rice cooker (Toyomi) at a ratio of rice to water of 1: 2
15826995|NCT04228341|Other|3 % polished rice|3% polished rice, containing 50 g of available carbohydrate was cooked using a rice cooker at a ratio of rice to water of 1: 2
15826996|NCT04228341|Other|6 % polished rice|6% polished rice, containing 50 g of available carbohydrate was cooked using a rice cooker at a ratio of rice to water of 1: 2
15826997|NCT04228341|Other|9 % polished rice|9 % polished rice, containing 50 g of available carbohydrate was cooked using a rice cooker at a ratio of rice to water of 1: 2
15826998|NCT04228341|Other|20 % Polished rice|White rice (20% polished rice), containing 50 g of available carbohydrate was cooked using a rice cooker at a ratio of rice to water of 1: 2.
15826999|NCT04228328|Diagnostic Test|The 6-minutes Walk Test|To walk for 6 minutes
15827000|NCT04228315|Drug|Primaquine|radical cure dosing
15827065|NCT04227769|Drug|Anakinra Prefilled Syringe|Subcutaneous injection of 100 mg/ 0.67 ml of Kineret or placebo
15827001|NCT04228302|Drug|EC5026 oral capsule|"5 sequential cohorts of 8 subjects randomly assigned to receive single ascending oral doses of EC5026 (n=6 per cohort) or matching placebo (n=2 per cohort).
~Oral doses of EC5026 tested in each cohort: 0.5 mg (Cohort 1), 2 mg (Cohort 2), 8 mg (Cohort 3), 16 mg (Cohort 4), and 24 mg (Cohort 5).
~A blinded sentinel group of 2 subjects (1 active and 1 placebo) will be dosed at least 2 days before the remaining 6 subjects (5 active and 1 placebo) will receive blinded doses of active study drug or placebo."
15827002|NCT04228302|Other|Placebo oral capsule|5 sequential cohorts of 8 subjects randomly assigned to receive single ascending oral doses of EC5026 (n=6 per cohort) or matching placebo (n=2 per cohort)
15827003|NCT04228289|Drug|Oxytocin|40 IU intranasal spray
15827004|NCT04228289|Other|Placebo|matching intranasal spray
15827005|NCT04228276|Device|Repetitive transcranial magnetic stimulation (rTMS)|rTMS is a non-invasive procedure in which administering a transient magnetic field induces electrical currents in specific, targeted brain regions. The intervention (active and sham) will be administered in 8 sessions across 2 weeks. The brain region targeted is the dorsolateral prefrontal cortex.
15827006|NCT04228263|Drug|Hydroxychloroquine|400mg
15827007|NCT04228263|Drug|Folic Acid|5 mg
15827008|NCT04228263|Drug|Low-dose aspirin|75 mg
15827009|NCT04228263|Drug|Placebo|oral tablet
15827010|NCT04228224|Device|Robot-assisted training with a lower extremity powered exoskeleton (H3 Exoskeleton, Spain)|The H3 is a powered lower extremity exoskeleton with actuated at hips, knees and ankles joints. A novel control software has been design and implemented in this device, which allows selective joint movement and recording of data from each rehabilitation session.
15827011|NCT04228224|Behavioral|Conventional gait rehabilitation|Conventional gait rehabilitation consist in walking and other applicable lower limb exercises performed by participants with assistance of a physical therapist.
15827012|NCT04228198|Procedure|Radical cystectomy|Procedure/Surgery: Radical cystectomy. Removal of urinary bladder with three different approaches: i) Robotic-assisted, ii) Laparoscopic, and iii) Open Surgery
15827013|NCT04228185|Procedure|sleeve gastrectomy|Comparison of banded and not-banded sleeve gastrectomy
15827014|NCT04228172|Genetic|DNA/GeneticTesting|Subjects will be tested for GBA and LRRK2 mutation status at baseline.
15827015|NCT04228172|Radiation|FDG PET scan|18F-Fluoro-2-deoxy-glucose (FDG) PET scan is a nuclear medicine test that measures glucose metabolism (energy) in your brain at baseline and 18 months later.
15827016|NCT04228172|Other|MRI scan|Magnetic Resonance Imaging (MRI) is a noninvasive scan which produces detailed pictures of the brain using a magnetic field. In addition, a special type of MRI, called resting state functional MRI (rs-fMRI), will measure and map brain activity. Conducted at baseline and 18 months later.
15827017|NCT04228172|Other|Clinical and neuropsychological assessments|Investigator will evaluate subjects according to the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS), the standard clinical tool used to measure the severity and progression of PD. Neuropsychological evaluation will assess how one's brain functions (via pencil and paper testing), which indirectly yields information about the structural and functional integrity of the brain. Conducted at baseline and 18 months later.
15827018|NCT04228159|Device|Balance Tutor Biofeedback Rehabilitation System|Balance Tutor system is a unique technology which allows for several postural control ability assessments as well as reactive response training in both standing and walking using controlled perturbation in simple task or multitask performance. Together with proactive training the system allows for optimal rehabilitation outcome and recovery
15827019|NCT04228159|Other|Balance and strengthening exercise|exercise training programs for fall prevention including walking and balance exercises, functional tasks, strength, flexibility and endurance
15827020|NCT04228146|Behavioral|Cognitive Behavioral Therapy for Insomnia|"Immediate access to the self-help CBT-I treatment, content of which is based on the translated Chinese version of a well-established CBT-I treatment manual entitled Insomnia: A Clinician's Guide to Assessment and Treatment. CBT-I aims at changing dysfunctional cognitive beliefs and maladaptive behaviors that contribute to the maintenance of insomnia. The self-help CBT-I treatment is delivered in Chinese language in six consecutive weekly modules via a smartphone application known as proACT-S. Duration of each module is around 45 to 60 minutes."
15827021|NCT04228146|Other|Waitlist Control|Delay access to the self-help CBT-I treatment.
15827022|NCT04228133|Behavioral|Attention Control Training (ACT)|A home-delivered version of ACT will be administered in this study. ACT will be comprised of 8 sessions with a variation of the dot-probe task in which the target probe replaces the neutral and threat stimuli with an equal probability to reduce attention bias variability (ABV). In addition, sessions will include video conference with the experimenter. This condition has found to be more effective in PTSD symptom reduction compared to ABM.
15827023|NCT04228133|Behavioral|Attention Bias Modification (ABM)|A home-delivered version of ABM will be administered in this study. ABM will be comprised of 8 sessions with a variation of the dot-probe task in which the target probe always replaces the threat stimuli to induce diversion of attention away from threat. In addition, sessions will include video conference with the experimenter. This condition has found to be have an inferior effect on PTSD symptom reduction compared to ACT, and thus, this ABM condition has been chosen as a control condition.
15827024|NCT04228120|Behavioral|self-regulation programme|The programme consisted of one 20-to-30-minute, face-to-face individual education session related to self-regulation and problem-solving processes that was performed in accordance with the patient's plan. Furthermore, eight 15- to 20-minute telephone follow-up counselling sessions were delivered twice per week for four weeks.
15827025|NCT04228107|Device|Medication monitoring|This is an observational study of medication use patterns. The propeller health device has reminders for controller medication use and gives feedback regarding medication use to the participant, their guardian and their asthma provider
15827026|NCT04228094|Other|TDApp1: an eHealth intervention|TDApp1 is a tool that uses GRADE heuristics to formulate participatory, individualized and automated therapeutic recommendations for patients with Attention Deficit Hyperactivity Disorder
15827061|NCT04227808|Drug|Lenvima 4 mg Oral Capsule|The participants will receive treatment with lenvatinib for 12 months after recruitment or until disease recurrence, intolerance AEs, or death. In case of treatment-related adverse effects, interruption or reduction is allowed.
15827062|NCT04227795|Device|Artificial intelligence-Assisted real time colonoscopy|The colonoscopy was performed under artificial intelligence assistance
15827027|NCT04228068|Other|Rehabilitation Program|"PT visits (two visits): The first visit will happen within a week of discharge. During this visit, the PT will assess participants, tailor the program to their needs, and coach them in carrying out the exercises at home. The last visit will be 12 weeks after the first. During this visit, the PT will reassess the participants and make adjustments to the program. The participants will be encouraged to continue exercising beyond the 12 weeks.
~The PTA will visit the participants' homes with the PT and will conduct additional solo visits every other week (i.e. 7 PTA visits in total, in 1st week and at 2, 4, 6, 8, 10, and 12 weeks). The PTA will facilitate and progress the exercise program as prescribed and directed by the PT and help in delivering the education component of the program."
15827028|NCT04228068|Other|Pain self management|In addition to the exercise program, the intervention group will receive a pain self-management support tailored by the PT to the participants' needs.
15827029|NCT04228068|Other|Conventional care|The control group will receive the usual care provided by the healthcare system.
15827030|NCT04228055|Behavioral|CLIPP2|Diabetes Prevention Program and Comprehensive Lifestyle Improvement Program with emphasis on a low carbohydrate and Keto diet, physical activity, sleep optimization and stress management.
15827031|NCT04228042|Drug|Infigratinib|Given PO
15827032|NCT04228042|Other|Quality-of-Life Assessment|Ancillary studies
15827033|NCT04228042|Other|Questionnaire Administration|Ancillary studies
15827034|NCT04228042|Procedure|Surgical Procedure|Undergo surgery
15827035|NCT04228029|Device|Carboxytherapy|Carbon dioxide (CO2) gas in injection form
15827036|NCT04228029|Drug|Intralesional Steroid Injection|triamcinolone acetonide 8 mg/mL
15827037|NCT04228016|Device|Device: nastent™|Patients with Nasal obstruction at night, will be used intrasal stent during 15 nights. These are flexible silicone tubes that are lubricated and easy to insert into the nasal cavities, which would restore the permeability of the nasal cavities.
15827038|NCT04228003|Dietary Supplement|Pendulum Glucose Control formulation for T2D|"All bacteria contained in the study product formulation are commensal organisms that have been repeatedly documented to inhabit the human GI tract under normal circumstances. Pendulum's Glucose Control Formulation consists of five human commensal microbial strains including butyrate producing and mucin-degrading strains. The organisms were grown under controlled conditions consistent with Good Manufacturing Practices (GMP) and employ no animal-derived products. All ingredients utilized during manufacturing were food grade and qualified as generally recognized as safe (GRAS).
~The product is provided as acid-resistant capsules in bottles that are to be stored refrigerated at 4℃."
15827039|NCT04227990|Drug|Plinabulin|Plinabulin (BPI-2358) is a synthetic, low molecular weight, new chemical entity that belongs to the diketopiperazine class of compounds. Plinabulin is intended for intravenous (IV) infusion and is diluted in D5W and administered for 30 minutes (± 5 minutes).
15827040|NCT04227990|Drug|Pegfilgrastim|Pegfilgrastim is a long-acting granulocyte colony-stimulating factor that stimulates the growth of neutrophils, to reduce the incidence of fever and infection in patients with certain types of cancer who are receiving chemotherapy that affects the bone marrow.
15827041|NCT04227990|Drug|Docetaxel, doxorubicin, and cyclophosphamide (TAC)|Docetaxel is a type of chemotherapy medicine called an taxane. Doxorubicin is a type of chemotherapy medicine called an anthracycline. Cyclophosphamide is a type of chemotherapy medicine called an alkylating agent.
15827042|NCT04227977|Device|JuxtaFlow System|The JuxtaFlow System consists of proprietary ureteral catheters deployed endoscopically over the wire to deliver mild controlled negative pressure into the renal pelvis.
15827043|NCT04227964|Device|Enamel matrix derivative, bone replacement graft, barrier membrane|
15827044|NCT04227964|Procedure|Tooth extraction and replacement|
15827045|NCT04227951|Device|Avoid drain placement|In No Drain arm (experimental) no abdominal drain is placed at the end of the operation.
15827046|NCT04227951|Device|Drain placement|In Drain arm (sham comparator) an abdominal drain is inserted in the abdomen from the right flank, passing below the liver (close to the duodenal stump) with the apex behind the esophago-jejunal (in total gastrectomy) or gastro-jejunal (in subtotal gastrectomy) anastomosis.
15827047|NCT04227938|Drug|ALPN-101|A single dose of ALPN-101 will be administered via intravenous infusion.
15827048|NCT04227925|Biological|Trichuris trichiura|Infective eggs from human whipworm, Trichuris trichiura
15827049|NCT04227912|Other|Transversus abdominis plane block|Before surgery, Ultrasound-guided TAP block was performed preemptively to Group TAP patients.
15827050|NCT04227912|Other|Local anesthetic infiltration|Before surgery, Ultrasound-guided Local anesthetic infiltration to the surgical incision line was performed preemptively to Group Local patients.
15827051|NCT04227912|Other|Intravenous dexketoprofen|Before surgery, 50 mg intravenous dexketoprofen was performed preemptively to Group dexketoprofen patients.
15827052|NCT04227899|Device|Esprit BTK Device|Participants will receive Esprit BTK Device
15827053|NCT04227899|Device|Percutaneous Transluminal Angioplasty (PTA) Device|Participants will receive PTA treatment
15827054|NCT04227886|Radiation|Radiation|Neoadjuvant radiotherapy consisted of 50 Gy in 25 fractions using intensity-modulated radiotherapy to the primary tumor and to mesorectal, presacral, and internal iliac lymph nodes.
15827055|NCT04227886|Drug|Capecitabine-Irinotecan Combination|The concurrent chemotherapy consists of capecitabine 625 mg/m2 twice daily 5 days per week and combined with weekly irinotecan. The irinotecan dose was used based on UGT1A1 genotype of 80mg/m2 for UGT1A1*1*1 or 65mg/m2 for UGT1A1*1*28 weekly, followed by a cycle of XELIRI.
15827056|NCT04227860|Other|Balance exercise program|"Patients will be engaged in lower extremity kinesthesia and balance exercise program 3 time per week for 6 weeks.
~Divided into 2 stages, stage 1 and 2, each stage 3 weeks. Patients who fulfill at least stage 1 of the program will be included in the study."
15827057|NCT04227860|Other|Strengthening exercise program|"Patients will be engaged in strengthening exercise program 3 time per week for 6 weeks.
~Divided into 3 stages, stage 1, 2 and 3, each stage 2 weeks. Patients who fulfill at least stage 1 of the program will be included in the study."
15827058|NCT04227847|Drug|SEA-CD70|Given into the vein (IV; intravenously) on Days 1 and 15 of each treatment cycle
15827059|NCT04227834|Behavioral|Health hygiene education|A cartoon video explaining the etiology, risk factors, clinical symptoms, treatment and prevention of helminthiasis were given to the school-aged children
15827063|NCT04227782|Diagnostic Test|Magnetic Resonance Imaging|Magnetic Resonance Imaging
15827066|NCT04227756|Drug|LSD|LSD 0.1 mg per os, single dose OR Psilocybin 20 mg per os, single dose OR Mescaline 300 mg per os, single dose OR Placebo
15827067|NCT04227756|Drug|Psilocybin|Psilocybin 20 mg per os, single dose
15827068|NCT04227756|Drug|Mescaline|Mescaline 300 mg or 500 mg per os, single dose
15827069|NCT04227756|Other|Placebo|Placebo (Mannitol)
15827070|NCT04227743|Device|cryobiopsy|. The cryobiopsy samples will be obtained by advancement of the cryoprobe into the working channel of the bronchoscope to touch the tip of the endobronchial tumor. The freezing time will be approximately 4 seconds. Then, flexible bronchoscope together with tissue sample attached to the tip of the frozen probe will be extracted outside the bronchial tree. The tissue sample will be released from the probe's tip by plunging it into saline at room temperature. FB will be reintroduced after cryobiopsy to evaluate and control the bleeding.
15827071|NCT04227730|Diagnostic Test|culture and PCR for group B streptococcus|all participants were evaluated by vaginorectal specimens for the detection of GBS, The swabs are placed in Amies transport medium and sent to the microbiology laboratory for testing by conventional PCR assay.
15827072|NCT04227717|Diagnostic Test|MRI with custom MRI spine coil|Participants will undergo MRI with custom MRI spine coil
15827073|NCT04227704|Drug|Ketamine 50 MG/ML|Administration of a 0.5 mg/kg dose of ketamine at cesarean delivery by one of two routes (subcutaneous or 40-minute IV infusion).
15827074|NCT04227704|Drug|Control|Administration of 0.9% Sodium Chloride (N/S)
15827075|NCT04227691|Device|Long-pulsed Nd Yag laser treatment|One treatment of the assigned axilla with long-pulsed Nd YAG laser treatment in ten patients
15827076|NCT04227691|Device|IPL treatment|One treatment of the assigned axilla with IPL treatment in ten patients
15827077|NCT04227678|Drug|Heparin|an intravenous (i.v.) heparin bolus (50 IU/kg i.v.) followed by 250 IU/h i.v. during 6 hours, starting 15 minutes before ingestion of liquid meal
15827078|NCT04227678|Dietary Supplement|liquid meal|low fat meal: (500 mL, 898 Kcal, 13% fat, 20.3% protein and 62.3% carbohydrates) will be ingested over 20 minutes
15827079|NCT04227665|Other|Sea level|Sea level exposure / sea level exposure combined with microdoses of rHuEPO
15827080|NCT04227665|Other|Altitude|Altitude exposure / altitude exposure Iron metabolism
15827081|NCT04227652|Drug|Ibuprofen administration|Administration of ibuprofen, according to treatment recommendations - per orally, into the nasogastric tube, or in the form of a suppository
15827082|NCT04227639|Procedure|T-piece trial|T-piece trial will be performed for around 1 hour with a T-piece connected to the extremity of the endotracheal tube by simply disconnecting the patient from the ventilator and by providing additional oxygen (≤ 6 L/min)
15827083|NCT04227639|Procedure|Pressure-support trial|Pressure-Support trial will be performed for around 1 hour without disconnecting the patient from the ventilator, by using a low level of pressure-support (PS 8 cm H2O) with a FiO2 ≤ 40% and without positive end-expiratory pressure (PEEP), while continuously monitoring the respiratory rate and tidal volume on the ventilator display.
15827084|NCT04227626|Device|GlucoSTAT|Closed-loop blood glucose control using intravenous insulin and dextrose
15827085|NCT04227600|Drug|JR-171|IV infusion
15827086|NCT04227587|Other|Zero Time Exercise|Zero Time Exercise encourage people to increase physical exercise by simple movements that can be done any time at any places. We offer a 2-session training course to train the subjects to do zero-time exercise.
15827087|NCT04227587|Other|Sleep hygiene education|We offer a 2-session education course to teach the subjects about sleep hygiene practice.
15827088|NCT04227574|Other|Zero Time Exercise training + WhatsApp anti-inertia reminders|"Zero Time Exercise encourage people to increase physical exercise by simple movements that can be done any time at any places. We offer a 2-session training course to train the subjects to do zero-time exercise.
~In addition, WhatsApp anti-inertia reminders will be sent daily by the research assistant to remind and encourage the participants to practice the Zero Time Exercise."
15827089|NCT04227574|Other|Zero Time Exercise training alone|Zero Time Exercise encourage people to increase physical exercise by simple movements that can be done any time at any places. We offer a 2-session training course to train the subjects to do zero-time exercise.
15827090|NCT04227561|Procedure|Pudendal nerve block|"Pudendal nerve block will be performed under general anesthesia and guided by neurostimulation.
~The local anesthetic solution (chirocaine 2.5mg/ml) will be injected in the ischiorectal fossa with a needle (a BBraun Stimuplex Ultra 360 22G 50mm needle) connected to a neurostimulator (Stimuplex HNS 12 neurostimulator). The neurostimulator will be used to determine the localization of pudendal nerve and to identify the precise site of injection. The contraction of the anal sphincter or bulbocavernosus muscle occurs when the pudendal nerve is reached.
~These procedure will be performed bilaterally."
15827091|NCT04227561|Procedure|Penile nerve block|"The local anesthetic solution (chirocaine 2.5mg/ml) will be injected under the fascia of Scarpa with a real-time ultrasound guidance.
~These procedure will be performed bilaterally."
15827092|NCT04227548|Diagnostic Test|needle electromyography|Direct muscle stimulation was performed to deltoid and tibialis anterior muscles with a monopolar needle electrode. Recording was made with a concentric needle electrode.
15827093|NCT04227522|Drug|Rucaparib|A starting dose of 600 mg Rucaparib is taken twice daily orally by the patients as maintenance after previous maintenance therapy (Bevacizumab) for a period of 12 to 15 months.
15827094|NCT04227522|Drug|Placebos|Placebo is taken daily orally by the patients as maintenance after previous maintenance therapy (Bevacizumab) for a period of 12 to 15 months.
15827095|NCT04227509|Drug|Pembrolizumab|Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
15827096|NCT04227509|Drug|placebo|normal saline will be administered as a 30 minute IV infusion every 3 weeks.
15827097|NCT04227496|Device|Auditory disturbances|A sound will be played from a portable device (smartphone) during movement
15827098|NCT04227483|Drug|Deflazacort|Deflazacort for 4 months
15827099|NCT04227483|Drug|Prednisolone|Prednisolone for 4 months
15827100|NCT04227470|Drug|HBM9161 Injection|Subcutaneous injection; Weekly administered for a period of 4 weeks. All subjects are treated with the testing drug, add on intravenous methylprednisolone (ivMP) with gradually reduce the dose then to oral prednisone. After the administration of the testing drug, if the subject's symptoms get worsen, a rescue therapy need to be adopted as based on Investigator's judgement, the testing drug injection should be discontinued.
15827101|NCT04227444|Diagnostic Test|Hologram|"Patient undergoing elective anatomical resection for lung cancer will receive standard preoperative CT scan of the chest (as usual); CT images will be subsequently elaborated by a Holographic computer to generate 3D images (holograms).Two radiologists and two thoracic surgeons will analyze CT images in a standard modality and report number of artery and vein branches for the lobe to be resected, moreover they will report every anatomical variation, according to the normal anatomy.
~After that, the same two radiologists and thoracic surgeons will analyze 3D images by the use of Microsoft Hololens and perform the same analysis as quoted above.
~For each review of the exam performed will be written a digitally signed clinical report to certify the timing of the evaluation and to be able to trace the analysis and any subsequent modifications of the interpretation of the CT images results."
15827102|NCT04227431|Other|Insulin degludec|Participants have been treated with Tresiba® (insulin degludec) for at least 20 weeks before entering the study. The study will be based on data already recorded in participants' medical records for approximately the last year and no new tests or procedures are required as part of the study.
15827103|NCT04227418|Device|12 lead ECG monitoring|Rate, Rhythm, QTc and PR interval will be assessed
15827104|NCT04227418|Device|6 lead ECG monitoring|Rate, Rhythm, QTc and PR interval will be assessed
15827105|NCT04227418|Device|Hand held ECG monitoring|Handheld ECG machines are portable, inexpensive, hand held devices that provide a 'real-time' rhythm strip, equivalent to lead I or II on a 12 lead machine, depending on how the device is held. The rhythm strip is displayed on a computer tablet or mobile phone, and are compatible with both android and iPhone platforms. To perform the test the patient places their fingers/thigh, or alternatively the device can be placed directly on the patient's chest. The process does not require the patient to be exposed, can be done in a seated position (negating the need an examination couch) and their ease of use and portability means they could be readily used in memory clinics or community settings.
15827106|NCT04227405|Behavioral|Connection to community services through case management|Case managers met with couple and conduct a needs assessment for the couple and their family. Then they developed an Individual and Couple Development Plan to take care of those needs, usually by accessing community services. Case managers met every 5 weeks with the couple to check on progress toward meeting the goals of the plan and assess for the present of any new needs.
15827107|NCT04227405|Behavioral|TOGETHER Workshop|Couples were required to participate in a 20 hour workshop (8 sessions of 2 1/2 hours each)in groups of 3 to 8 couples. These groups were facilitated by a financial expert and a couples' expert. The workshop is interdisciplinary and psycho-educational. Couples learn about skills to improve their communication about stress and money problems, conflict resolution, individual and couple stress management in general and about money stress in particular, and financial management
15827108|NCT04227405|Behavioral|Employment Support Services|Only for those participants that were in need of employment support services. If the needs assessment conducted by the case manager indicated an employment or career need. After completion of the TOGETHER workshop, an employment case manager met with the participant, conducted an employment needs assessment and connected the participant with a workforce agency or one-stop employment centers. After doing so, the employment case manager followed through the various steps that the participant had to complete as part of the employment services for a period of 6 months
15827109|NCT04227392|Device|vaginal radiofrequency|2 sessions of vaginal radiofrequency therapy with 3 week interval. A session last 20 minutes.
15827110|NCT04227379|Behavioral|Intervention 1- DD-TXT|Participants in this group will be signed up for an interactive, tailored self-management texting protocol (DD-TXT). The DD-TXT protocol will consist of: Core Messaging: Customizable core modules on medication management, blood sugar and blood pressure monitoring, preventive care, problem solving, appointment reminders, administrative messages; and Optional Messaging: A library of patient-selected modules (e.g. nutrition, physical activity, weight management, emotional coping, goal setting) designed to motivate and educate.
15827111|NCT04227379|Behavioral|Comparison - DSE|"The comparison condition will be signed up for a one-way education-only protocol called Diabetes Skilled Education-Only (DSE). DSE contains only one-way educational content consisting only of content from the VA educational workbook entitled Self-Care Skills for the Person with Diabetes, which was created in alignment with VA/DoD diabetes guidelines and is recommended for patients as part of usual care. Everyone in the DSE arm will receive the same daily text messages taken verbatim or almost verbatim from workbook content but shortened to fit the 160-character limit of a text message (See Appendix 3 for sample messages from workbook). There will be no customizable or interactive content for the DSE arm."
15827112|NCT04227366|Biological|BCD-089|BCD-089 162 mg SC
15827113|NCT04227366|Biological|Placebo|Placebo
15827114|NCT04227366|Drug|Methotrexat|15 to 25 mg/week
15827115|NCT04227353|Behavioral|HEAL ABC|Participants will be assigned their first booklet based on the one they perceive to be the easiest for setting an incremental goal and achieving it. After the participant achieves successful behaviour change, he or she can move more confidently to the next booklet. Support will be provided every two weeks over the phone for 12 weeks. During the follow-up period, participants will use the follow-up booklet which helps them to continue with changes they have made and encourage them to set new goals.
15827116|NCT04227340|Device|Photobiomodulation Therapy (PBM)|The PBM will be delivered through application of the LED Cluster Probe externally to the right external buccal, left external buccal, mid face with mouth open and submandibular and left/right cervical. Patients who develop an oral lesion, intra-oral directed therapy will be administered with the dental light probe. For patients that can tolerate, an intraoral probe will deliver light directly onto the oral mucosa, this will then replace the mid face application with mouth open. Each laser application will be timed at 60 seconds.
15827117|NCT04227340|Other|Pain and Oral Function Assessment|After the 6-minute laser/ treatment session the child and parent will complete the mucositis evaluation scale on paper or ipad which includes self-report oral function specific to ability to swallow, eat and drink, as well as the patient's self-reported need for medication specific to mouth pain.
15827118|NCT04227340|Other|Parent-Reported Satisfaction Survey|A parent-reported satisfaction survey will be administered via paper questionnaire after the initial LLLT treatment. Parent satisfaction will be reported by parents on a 5-point Likert scale to questions adapted from a parent satisfaction survey used in a study regarding child life services in pediatric imaging.
15827119|NCT04227327|Drug|Abemaciclib|Abemaciclib will be administered orally at 150 mg twice daily
15827121|NCT04227314|Drug|Apremilast|Apremilast: 30 mg twice daily during a 12 week double blind placebo controlled period, then 30 mg twice daily during an additional 12 week active treatment period
15827122|NCT04227314|Drug|Placebo oral tablet|Placebo: 30 mg twice daily during the initial 12 week double blind placebo controlled period,
15827123|NCT04227301|Other|blood sampling|blood sampling for measurement of bone markers after a fasting period of at least 6 hours
15827124|NCT04227288|Drug|Enstilar Foam|Subjects will be instructed to apply a thin layer on the nail plate, around the nail plate and under the nail plate. The patient will be instructed to apply one application at night immediately before bed and not wash their hands before morning. All subjects who completed the 6-month treatment will be followed for 1 month after discontinuation.
15827125|NCT04227275|Biological|CART-PSMA-TGFβRDN|Intravenous administration of genetically modified autologous T cells engineered to express a protein capable of recognizing the tumor antigen prostate-specific membrane antigen (PSMA), as well as a dominant negative TGFβ receptor
15827126|NCT04227275|Drug|Cyclophosphamide|Patients will receive cyclophosphamide and fludarabine lymphodepletion chemotherapy followed by the investigational product, CART-PSMA-TGFβRDN genetically modified T cells
15827127|NCT04227275|Drug|Fludarabine|Patients will receive cyclophosphamide and fludarabine lymphodepletion chemotherapy followed by the investigational product, CART-PSMA-TGFβRDN genetically modified T cells
15827128|NCT04227275|Drug|Anakinra|In applicable cohorts, patients will receive anakinra prophylactically starting on the day of administration of investigational product, CART-PSMA-TGFβRDN genetically modified T cells
15827129|NCT04227262|Other|MIRROR THERAPY|The children were instructed to sitting on chair and a mirror is placed in midsagittal plane of the child, with the normal limb in front of mirror and the affected limb is blocked so the patient see only the reflected movement of the sound limb (non affected).
15827130|NCT04227249|Procedure|no lymph node dissection|do not undergo lymph node dissection
15827131|NCT04227236|Other|E-based virtual facilitator training for Making Proud Choices|Participants complete the Making Proud Choices (MPC) facilitator training using an e-based virtual trainer on a computer. Making Proud Choices! (MPC) is an evidence-based pregnancy and HIV/STI risk-reduction program for youth. The facilitator training prepares educators to effectively deliver the MPC curriculum.
15827132|NCT04227236|Other|In-person facilitator training for Making Proud Choices|Participants complete the Making Proud Choices (MPC) facilitator training using the standard in-person training method. Making Proud Choices! (MPC) is an evidence-based pregnancy and HIV/STI risk-reduction program for youth. The facilitator training prepares educators to effectively deliver the MPC curriculum.
15827133|NCT04227223|Diagnostic Test|biochemical measurements|TOC,TAC, and BDNF measurements are performed using ImAnOx , PerOx and BDNF tests (Immundiagnostik, Germany)
15827134|NCT04227210|Biological|RSV vaccine MV-012-968 (dosage #1)|Single dose administered intranasally on Day 1
15827135|NCT04227210|Biological|RSV vaccine MV-012-968 (dosage #2)|Single dose administered intranasally on Day 1
15827136|NCT04227197|Other|Down Syndrome Clinic to You (DSC2U)|DSC2U is a web-based tool for families to get up-to-date, personalized health and wellness information, based on national guidelines and expert consensus, for a person with Down syndrome.
15827137|NCT04227184|Drug|Trospium|Drug to treat overactive bladder
15827138|NCT04227184|Drug|Placebo oral tablet|Placebo tablet containing no active drug
15827140|NCT04227132|Device|Adaptive computer game training|Patients sit in front of a computer monitor and play the adaptive videogame with a joystick. The game requires to orient and move inside a maze, and it includes phases that engage multitasking abilities. The level and speed of the game is adapted online to patients' performance.
15827141|NCT04227132|Device|Standard computerized training|Patients sit in front of the computer monitor and perform simple computerized exercises using a keyboard to respond. Exercises are organized into modules according to the trained cognitive functions. Patients will perform four different modules that are designed for neglect rehabilitation. The level of exercises adapts periodically based on patient's performance.
15827142|NCT04227119|Device|Irrigated ablation catheter|After completion of ablation, the ablation catheter will be serially positioned in the cardiac chambers (either the left or right side of the heart). The stop cock will be turned to the pressure transducer and waveforms will be stored corresponding to each chamber.
15827143|NCT04227119|Device|Balloon tipped PA catheter|After removal of the irrigated ablation catheter, a 5F balloon tipped PA catheter which will be positioned under fluoroscopic guidance in each previously evaluated chamber and the chambers will be measured again.
15827144|NCT04227106|Biological|EB-101|autologous RDEB keratinocytes isolated from skin biopsies and transduced with a recombinant retrovirus containing a full-length COL7A1 expression cassette for C7
15827145|NCT04227093|Drug|Acetazolamide|Oral acetazolamide tablets of 250 mg taken twice daily.
15827146|NCT04227093|Drug|Placebo|Matching placebo tablets taken twice daily.
15827147|NCT04227080|Drug|BH4|oral administration of 20 mg/kg KUVAN (BH4)
15827148|NCT04227067|Device|TENS|An electrical impulse is delivered to the skin around the painful area using pads attached to an electric generator.
15827149|NCT04227067|Device|SHAM TENS|A TENS generator without batteries is used. The pads are attached to the generator and to the skin around the painful area.
15827150|NCT04227054|Device|IMPEDE-FX Embolization Plug|Fill an abdominal aortic aneurysm (AAA) sac outside of an endovascular aneurysm repair (EVAR) stent graft
15827151|NCT04227041|Drug|Pyrotinib in combination with capecitabine|Pyrotinib in combination with capecitabine
15827152|NCT04227028|Biological|Bevacizumab|Given IV
15827153|NCT04227028|Drug|Brigatinib|Given PO
15827154|NCT04227015|Drug|CTA101|CTA101 UCAR-T cell injection by intravenous infusion
15827155|NCT04226989|Biological|CT-RD06|CT-RD06 cell injection by intravenous infusion
15827220|NCT04226482|Device|Used Device|Laparoscopic appendectomy using reprocessed ultrasonic shears.
15827156|NCT04226976|Device|Otoband|Participants with AUV will wear the Otoband set at normal power (effective) during vestibular test battery and outcome measurements will be recorded by the investigator during site visit.
15827157|NCT04226976|Device|Placebo Device|Participants with AUV will wear the placebo device set at low power during vestibular test battery and outcome measurements will be recorded by the investigator during site visit.
15827158|NCT04226963|Drug|Ketamine|Ketamine will be infused (slow IV infusions of ketamine (0.5 mg/kg) over 40 minutes) twice weekly over a period of 4 weeks) Ketamine will be given in intranasal spray twice weekly over a period of 4 weeks Ketamine will be given orally (solution 2.0mg/kg, 2.5mg/kg) twice weekly over a period of 4 weeks.
15827159|NCT04226950|Drug|Recombinant Interferon Alpha|Recombinant Interferon Alpha, with an initial dose of 300 wu twice a week. Other interferons that have been listed can be used if Recombinant Interferon Alpha (300 wu) is not available, and the specific dose will be determined by the researchers;
15827160|NCT04226950|Drug|Pegylated interferon alfa-2b|Pegylated Interferon Alfa-2b, with an initial dose of 135 ug once a week (body surface area < 1.73 m2) or 180 ug once a week ( body surface area≥1.73 m2).
15827161|NCT04226937|Other|Not Applicable as this is a translational, sample collection study.|"Patients will take their normal standard of care treatment for their lymphoma, as per agreed with the patient's doctor.
~Blood samples will be collected at Baseline, during the first 3 cycles of Treatment, at End of Treatment, at 6- and 12-months after End of Treatment and at relapse/progression if applicable.
~Surplus Tissue biopsy will be collected at Baseline and at relapse/progression if applicable. In rare cases research-specific tissue biopsy may be collected if appropriate."
15827162|NCT04226924|Drug|Trehalose|90 mg/ml trehalose solution for IV infusion
15827163|NCT04226911|Behavioral|S&SEs|"S&SEs:
~As many sugar-containing products in the diet as possible should be replaced with S&SE-containing products.
~To ensure that a certain amount of S&SE products is consumed every day, a fixed minimum amount for each individual is planned."
15827164|NCT04226911|Behavioral|Sugar|"Sugar group:
~A person in the sugar group is allowed to consume up to a certain number of units of sugar-containing products each day, corresponding to < 10 E% added sugar.
~The sugar group is not allowed to consume any S&SE products."
15827165|NCT04226898|Biological|Synbiotic Supplement|Synbiotic supplement 1 powder stick by mouth daily
15827166|NCT04226898|Biological|Inert Compound|Synbiotic supplement identical placebo 1 powder stick by mouth daily
15827167|NCT04226885|Drug|fentanyl|nebulized fentanyl 2μg/kg body weigh
15827168|NCT04226885|Drug|midazolam|nebulized midazolam 0.2 mg/kg body weight 30 min before surgery.
15827169|NCT04226885|Drug|dexmedetomidine|nebulized dexmedetomidine 2 μg/kg body weight 30 min before surgery.
15827170|NCT04226872|Behavioral|My Tools for Care - In Care|Self-administered web-based transition toolkit (My tools 4 Care - In Care) contains interactive activities and resources to help carers through transitions that they face after the person living with dementia has moved to a long-term care setting.
15827171|NCT04226859|Other|No intervention|Kidney recipients aged over 18 and of all sexes recruited from 2000 in European and North American centers, who have eGFR follow-up and data from protocol and for cause biopsies available for allograft survival assessment; Randomized controlled trials conducted over the past 20 years with available data on protocol biopsy within the first year and follow up clinical, biological and histological data.
15827172|NCT04226833|Drug|entrectinib|1x100 milligram (mg) capsule given with approximately 240 milliliter (mL) of water within 30 minutes of consumption of a standardized meal
15827173|NCT04226820|Other|examination: blood pressure assessment|blood pressure measurement for 30 minutes, dominant side
15827174|NCT04226820|Other|examination: Flow Mediated Dilatation (FMD)-test|Flow Mediated Dilatation (FMD)-test for measuring the endothelial functionality
15827175|NCT04226820|Other|examination: handgrip exercise test with Near infrared spectroscopy (NIRS)-monitoring|participant does a maximal exercise test by a handgrip strength test with simultaneously monitoring of the muscular oxygenation
15827176|NCT04226820|Other|examination: measurement of glucose by a finger prick|follow-up of blood sugar (glucose) during examinations by a finger prick
15827177|NCT04226807|Other|Early Postpartum Phone Call|Participants receive a phone call 2-3 weeks after birth asking about overall wellbeing, screening for complications and postpartum depression and referring to lactation or WIC as needed.
15827178|NCT04226794|Device|a-tDCS|Anodal Transcranial direct current stimulation (tDCS) stimulation. Anode will be allocated at DLPFC right and cathode at DLPFC left. The stimulation will occur for 20 min in the intensity of 2 milliampere (mA).
15827179|NCT04226794|Behavioral|Nutritional Counseling|Presentation delivered through video clip during 20 minutes based on Cognitive Behavioral Therapy interventions
15827180|NCT04226794|Combination Product|a-tDCS and nutritional counseling|a-tDCS + Nutritional Counseling
15827181|NCT04226794|Combination Product|s-tDCS and nutritional counseling|s-tDCS + Nutritional Counseling
15827182|NCT04226781|Diagnostic Test|Hyperspectral-Imaging|Photos were taken with the hyperspectral camera of the gastrointestinal anastomosis.
15827183|NCT04226781|Diagnostic Test|Indocyaningreen-Fluorescence imaging|Photos were taken with the Fluorescence camera after injection of the indocyaningreen-dye of the gastrointestinal anastomosis
15827184|NCT04226768|Other|"Enhanced Haematology Palliative Care (Fast-track) Group"|Early and proactive multidisciplinary care
15827185|NCT04226768|Other|Conventional Care|Conventional care and referral as indicated
15827186|NCT04226755|Dietary Supplement|Sodium chloride|1 gram tid (with every meal)
15827187|NCT04226742|Behavioral|ADAPT Platform (Treatment)|The ADAPT platform consists of 2 modules based on evidence-based strategies from cognitive-behavioral therapy including cognitive restructuring and behavioral experiments. The platform includes didactic material, interactive tools, and crowd-features. Crowd-features are present to increase personal relevance of content and to promote engagement with the ADAPT platform through accountability. Crowd-features include requesting, responding, and exemplars.
15827188|NCT04226742|Behavioral|ADAPT Comparison (Control)|The control platform is a self-guided version of the ADAPT platform that includes no crowd-features. As such it will include only didactic material on cognitive restructuring and behavioral experiments and interactive tools.
15827221|NCT04226469|Procedure|Tooth movement|The subject's canines will be retracted distally and crevicular fluid is collected
15827189|NCT04226716|Behavioral|Assessment of postural control, body perception and psychosocial factors|Behavioral assessment of postural control, lumbar proprioceptive use during postural control, back-specific body perception and psychosocial factors (incl. perceived harmfulness of daily activities, pain-related fear of movement, fear-avoidance beliefs, (pregnancy-related) depression, anxiety and stress, optimism/pessimism, pain coping and coping with stressful life events)
15827190|NCT04226703|Diagnostic Test|Ultrasonographic upper airway measurements|"Ultrasonographic upper airway measurements: Epiglottis-skin distance, Hyoid bone-skin distance, Anterior commissure-skin distance and Thickness of tounge root.
~Indirect Laryngoscopy: Grading of laryngoscopic view (I=Visible anterior commissure and vocal cords, II= visible posterior part of vocal cords and posterior commissure, III= Visible posterior commissure and epiglottis, IV= Visible only epiglottis tip and posterior pharyngeal wall)"
15827191|NCT04226690|Drug|Active Dose 1|Subjects will self-administer the assigned study medication daily at home after pickup and will be tested using medication compliance procedures. Subjects will visit the center 2 times in the 7-day period on days 1 and 7 for blood draws to assess medication compliance.
15827192|NCT04226690|Drug|Active Dose 2|subjects will self-administer the assigned study medication daily at home after pickup and will be tested using medication compliance procedures. Subjects will visit the center 2 times in the 7-day period on days 1 and 7 for blood draws to assess medication compliance.
15827193|NCT04226690|Drug|matched placebo|subjects will self-administer the assigned study medication daily at home after pickup and will be tested using medication compliance procedures. Subjects will visit the center 2 times in the 7-day period on days 1 and 7 for blood draws to assess medication compliance.
15827197|NCT04226664|Procedure|Bariatric surgery|Although there may be slight variation by centre, Gastric Bypass generally involves creation of a 30-50 cc stomach pouch, which is anastamosed with a Roux limb of jejunum 75-100 cm in length and a biliary limb of 20-30 cm in length. The operation creates a small gastric pouch, with nutrients bypassing the duodenum and proximal jejunum. Sleeve Gastrectomy involves decreasing the size of the stomach to approximately 15% of its original size by resecting a large portion of the stomach along the greater curvature.
15827198|NCT04226651|Device|Virtual Reality Device|The Virtual Reality system (PlayStation 4 VR, Sony Inc.) is a simple and easy to use distraction device. The system consists of a screen mounted on a binocular headset connected to a console or personal computer. The head-mounted display provides a high-resolution visual display and unmutes the sound from the headphones using a soundproof mechanism that provides clear sound.
15827199|NCT04226651|Device|Protective glasses|Each patient was informed about the dental procedure and was provided with protective glasses. All patients were told that they were wearing these glasses to ensure a pain- and stress-free treatment, and that the dentist would devote additional attention to the treatment.
15827200|NCT04226638|Diagnostic Test|Dynamic ultrasound|Diagnosis was based on clinic suspicion and positive ultrasonography dynamic maneuvers by reproducing pain and slipping rib exam
15827201|NCT04226625|Drug|Propofol|Intravenous administration
15827202|NCT04226625|Drug|Desflurane|Volatile administration
15827203|NCT04226599|Device|Dissolve AVF|Subjects in the test group will be treated with peripheral scoring drug balloon.
15827204|NCT04226599|Device|Armada 35|Subjects in the test group will be treated with plain balloon catheter.
15827205|NCT04226586|Dietary Supplement|Essential Amino Acid (EAA) group|Eligible children will be supplemented with Essential Amino Acids (EAA) for 6 months twice a day. Caution will be exercised to match the groups for age and sex.
15827206|NCT04226586|Dietary Supplement|Placebo|Eligible children will be supplemented with a placebo for 6 months twice a day. Caution will be exercised to match the groups for age and sex.
15827207|NCT04226573|Other|Preoperative anxiety levels|"Serums were separated from blood samples taken from all patients in the study, Using the anti-human TNF-α and IL-6 enzyme-linked immunosorbent assay (ELISA) kits in the Elisa device, the TNF-α and IL-6 cytokines will be measured to determine their concentration.
~No routine blood will be drawn during the procedures. Preoperative anxiety levels will be evaluated with STAI-Continuity and STAI-Statefulness scale."
15827208|NCT04226560|Device|41% Silicone Hydrogel Soft Contact Lenses(SHSCL)|Silicone Hydrogel
15827209|NCT04226560|Device|ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact Lens|Senofilcon C (USFDA Device License #K160212)
15827210|NCT04226560|Other|Contact Lens Care Product|Cefatrizine (propylene Glycol), Sodium Citrate (sodium Citrate Tribasic), Sodium Chloride, Sodium Borate (sodium Biboratesodium Tetraborate, Polyquaternium -1, Hydrochloric Acid, Sodium Hydroxide, Water Purified ( Eq to Aqueous Purified Or Purified Water ), Tetronic 1304, Myristamidopropyl Dimethylamine, Nonanoyl Ethylenediaminetriacetic Acid
15827211|NCT04226560|Other|Contact Lens Case|"Alcon Soft (hydrophilic) Contact Lens Case (Non-Sterile)"
15827212|NCT04226547|Device|Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder)|Implantation of an Amplatzer Amulet left atrial appendage occluder
15827213|NCT04226547|Drug|Non-Vitamin K Oral Antagonists|Initiation or continuation of a NOAC drug
15827214|NCT04226534|Other|Maximal effort test|Performing a maximal effort test on the treadmill
15827215|NCT04226521|Procedure|Extracoropreal photopheresis|Patients who sign informed consent form undergo prophylactic extracorporeal photopheresis after heart transplant according to predetermined protocol
15827216|NCT04226508|Other|Physical exercise|"The patients can choose between three modality of EX:
~Autonomous supervised training : a personalized activity is proposed. People choosing this modality have a written material, in which all the exercise, the activity, the frequency, the duration, the intensity are specifically described and reported, to perform the training at home. A training diary and 7 meetings (face to face, or skype or other modality) are proposed for monitoring the intervention.
~Personal training program: a personalized activity is proposed. Patients are followed individually in a gym contest by a qualified kinesiologist.
~Group training program: the training is performed in a small group, supervised and monitored by a qualified kinesiologist. The instructor-user ratio is 1:4 - 1:8, depending on the functional conditions and the heterogeneity of the participants."
15827217|NCT04226495|Drug|Sufentanil Infusion|Intra-operative sufentanil infusion
15827222|NCT04226456|Drug|N-acetyl cysteine|Injection of a 10% solution of N-acetylcysteine through transtympanic injection in both ears
15827223|NCT04226443|Drug|Midazolam intravenous injection|The midazolam was prepared as 5 mg midazolam in 20 mL syringe of 5% dextrose water solution (0.25 mg/mL) in both arms. Both groups of patients received an intravenous bolus dose of midazolam was administered before the start of the surgery. In Group 1, continuous infusion of intravenous midazolam was started and in Group 2, intravenous bolus doses of midazolam were administered. The doses were adjusted depending on pain level and sedation level using appropriate scales for monitoring during the surgical time period. The drip rate was adjusted according to pain intensity. The infusion of drugs was discontinued at the end of the procedure.
15827224|NCT04226443|Drug|Remifentanil intravenous bolus dose|A remifentanil infusion was prepared as follows; 0.5 mg remifentanil was added into 100 mL of 0.9% saline at a concentration of 5 μg/mL. The preparation of remifentanil solution and installation of the device was done by an anesthesiologist who was blinded for the study groups. The dose and number of patients that required remifentanil were recorded. The infusion of drugs was discontinued at the end of the procedure. A rescue medication of intravenous remifentanil bolus dose was used as 1 to 3 mL (5 μg or 15 μg) every 5 minutes if necessary for pain scores greater than 3. This infusion was prepared prior to the use during the study and was discontinued at the end of the procedure.
15827225|NCT04226430|Device|Cytokine aphaeresis|The Cytosorb cartridge was either used alone in hemoperfusion mode or, if renal replacement therapy was clinically indicated, inserted proximally into a conventional continuous veno-venous hemofiltration (CVVH) or continuous veno-venous hemodiafiltration (CVVHDF) circuit. Before the start of the Cytosorb therapy, adequate anti-coagulation was confirmed when target partial thromboplastin time (PTT) of 60±80 seconds, or an activated clotting time (ACT) of 180±210 seconds was achieved with systemic heparin. Antibiotics were administered after each Cytosorb therapy whenever possible.
15827226|NCT04226417|Device|Transcranial direct current stimulation|Dual/ Sham tDCS will be applied in 2 mA, 20 mins before the home-based exercise program in 3 times per week for 4 weeks (12 sessions)
15827227|NCT04226404|Other|CSD1905-11|Flavor variant CSD1905-11 of a 4.8% nicotine ENDS product
15827228|NCT04226404|Other|CSD1905-12|Flavor variant CSD1905-12 of a 4.8% nicotine ENDS product
15827229|NCT04226404|Other|CSD1905-13|Flavor variant CSD1905-13 of a 4.8% nicotine ENDS product
15827230|NCT04226404|Other|CSD1905-14|Flavor variant CSD1905-14 of a 4.8% nicotine ENDS product
15827231|NCT04226404|Other|CSD1905-15|Flavor variant CSD1905-15 of a 4.8% nicotine ENDS product
15827232|NCT04226404|Other|CSD1905-16|Flavor variant CSD1905-16 of a 4.8% nicotine ENDS product
15827233|NCT04226404|Other|CSD1905-17|Flavor variant CSD1905-17 of a 4.8% nicotine ENDS product
15827234|NCT04226378|Device|Omnipod|Switch from MDI therapy to an Omnipod as part of usual clinical practice. An Omnipod is a patch pump that consists of a handheld controller and a disposable pod that delivers insulin.
15827235|NCT04226378|Other|MDI|Continued use of MDI therapy (traditional basal/bolus insulin regimen).
15827236|NCT04226365|Drug|Nortriptyline|10mg capsule Nortryptyline
15827237|NCT04226365|Drug|Placebo|10mg capsule Thick-It filler
15827239|NCT04226339|Procedure|total knee arthroplasty with a kinetic alignment|"During surgery, a SPHERE prosthesis will replace the knee and the femorotibial alignment.
~it will be set to reproduce the preoperative constitutional deformity in varus or valgus as it was measured before surgery"
15827240|NCT04226339|Procedure|total knee arthroplasty with a mechanical alignment|"During surgery, a SPHERE prosthesis will replace the knee and the femorotibial alignment.
~It will be set to 180° as defined for a mechanical femorotibial alignment"
15827241|NCT04226326|Other|Directly measure microvascular function using direct coronary flow measurements|The study will enroll subjects who have been scheduled for a clinically-indicated cardiac catheterization, and will evaluate coronary microvascular function in all subjects meeting inclusion criteria with a coronary flow wire. Evaluation of coronary microvascular function may be performed using indirect methods, however the rationale behind the present study is to directly measure microvascular function using direct coronary flow measurements, since the subjects in the study are to undergo a clinically-indicated cardiac catheterization. The overall purpose of the study is to define the presence and severity of coronary microvascular dysfunction subjects with CTO.
15827242|NCT04226313|Diagnostic Test|Self-sampling by Evalyn Brush|Women will perform a cervicovaginal self-sampling at their home using Evalyn Brush.
15827243|NCT04226313|Diagnostic Test|Self sampling by Evalyn Brush home or in GP´s clinic|Women will perform a cervicovaginal self-sampling at their home or the GP´s clinic using Evalyn Brush
15827244|NCT04226300|Procedure|Laparoscopic|A transversus abdominis nerve block will be placed laparoscopically.
15827245|NCT04226300|Procedure|Ultrasound|A transversus abdominis nerve block will be place by ultrasound
15827246|NCT04226287|Device|Monterey Pneumatic Compression Device|The MontereyInvestigational System is a compact pneumatic compression device used for the treatment of either primary or secondary lymphedema. The primary intention in this study is to gather usability design feedback. This will be done by observing how a patient uses the device after a brief demonstration from the clinician. Errors and difficulties will be noted by the ResMed representative observing the trial. The qualitative interview with the patient at the end of the trial will yield additional understanding of the patient experience with the device.
15827247|NCT04226274|Drug|REN001|Once daily for 12 weeks
15827248|NCT04226248|Drug|Rivastigmine Transdermal System|Rivastigmine Trandermal Patches applied once a day for up to 12 months
15827249|NCT04226248|Other|Placebo Transdermal System|Placebo Trandermal Patches applied once a day for up to 12 months
15827250|NCT04226235|Behavioral|Yoga session|a 1-hour yoga session was completed by all participants following a DVD.
15827251|NCT04226222|Diagnostic Test|TEP-TDM FDG|Semi-quantitative PET-TDM FDG Data and Texture Analysis
15827252|NCT04226209|Other|PSSE|Physiotherapeutic Scoliosis-Specific Exercises (PSSE) group will receive exercise for 30-40 mins in a day, twice in a week, totally 8 weeks and 16 hours. Control group will be taught the basic elements of corrective exercises and want them to do the practising during 8 weeks at home.
15827253|NCT04226196|Device|Implantation of an intraocular lens|Implantation of an intraocular lens Zeiss 409 MP into the capsular bag using an injector, after removing of the human crystalline lens.
15827254|NCT04226183|Other|pregnancy workout|"Procedure of pregnancy workout has been legalized by the Ministry of Health of Indonesia act 2014 No.97.
~100 ml fresh guava juice without sugar"
15827255|NCT04226170|Drug|DAS-001|ondansetron + pyridostigmine
15827256|NCT04226157|Device|Home Blood Pressure Monitoring Device (Qardio Arm)|The Home Blood Pressure Device with telemonitoring capability will allow the participants and physician to monitor blood pressure over time and titrate blood pressure medications as needed for persistently elevated blood pressure.
15827257|NCT04226157|Other|Primary Care Provider Blood Pressure Management|Participant will follow up as would normally do with primary care provider for blood pressure management.
15827258|NCT04226144|Device|Breath Stacking Group|Lung recruitment technique using manual bag resuscitation with oronasal mask interface
15827259|NCT04226144|Device|Breath stacking and EMT|Lung recruitment technique with one way valve with counter resistance during all expiratory phase
15827260|NCT04226131|Other|Blood Draw|A study nurse will draw up to 150 mL of blood to measure erythrocyte sedimentation rate (ESR) and measures of immune cell function. ESR is a common hematology test that is a measure of inflammation.
15827261|NCT04226131|Other|Disease Activity (DAS-28) Assessment|Participants in the RA cohort will receive a 28-joint examination by the study physician to assess RA disease activity and report their overall health assessment.
15827262|NCT04226131|Other|Skeletal Muscle Mitochondrial Respiratory Capacity|Near-Infrared Spectroscopy (NIRS) will be used to measure oxidative capacity of forearm flexor digitorum profundus and medial gastrocnemius muscles using the PortaMon device (Artinis Medical Systems, The Netherlands). NIRS is a low-cost, non-invasive method that estimates muscle oxidative capacity by measuring oxygen consumption (mVO2) recovery kinetics via assessment of intramuscular oxy- and deoxy-hemoglobin concentration following a sequence of brief, rapid arterial cuff occlusions. NIRS measures mitochondrial oxidative function as the mVO2 recovery rate constant k. In the absence of blood flow, changes in muscle oxygenation occur via oxygen consumption alone. In persons without RA, this non-invasive approach is highly correlated with muscle respiratory capacity assessed via muscle biopsies using in situ permiabilized fiber bundles and the Oroboros O2k system.
15827263|NCT04226131|Other|Muscle Biopsy|After local anesthesia (xylocaine, 2%) is injected, a small incision will be made in the thigh. Four to six small pieces of muscle about the size of a pea will be surgically removed. The incision site will be closed using steri-strips and/or derma-bond, and a light dressing applied.
15827264|NCT04226131|Other|Body Composition|Body composition assessments include circumference measurements and the BOD POD®. Minimal waist circumference measurements will be taken using a tape measure.
15827265|NCT04226131|Other|Cardiopulmonary Exercise Test (CPET)|Cardiorespiratory aerobic capacity (VO2 peak), will be assessed using a maximal treadmill test protocol with cardiopulmonary gas exchange. Subjects will be asked to exercise on a treadmill to their perceived maximum ability and effort during which time they will have a mouthpiece in their mouth to determine maximal oxygen use/consumption through breathing. For safety purposes the subject will be monitored by electrocardiogram (ECG) and their blood pressure will be measured at rest and throughout the exercise phase of this test.
15827266|NCT04226131|Other|Strength Testing|Strength assessments will include dynamometry-assessed grip and quadriceps strength (Cybex HUMAC NORM, Comp Sports Med, Inc., Stoughton, MA) tests
15827267|NCT04226131|Other|Questionnaires|Measures include global health, pain, fatigue, physical function, self-efficacy for disease management and sleep.
15827268|NCT04226131|Other|Skeletal Muscle Biomechanical Property Assessment|Passive skeletal muscle stiffness and elasticity measurements of bilateral biceps brachii, flexor carpi radialis, vastus lateralis, and tibialis anterior using mechanical deformation with myotonometry using the MyotonPro device.
15827269|NCT04226118|Device|Vein Illumintion System device|Spotting veins of a patient by use of a Vein Illumintion System device
15827270|NCT04226105|Drug|GP40081|1 ml of the GP40081 contains 100 units soluble insulin aspart/protamine-crystallised insulin aspart in the ratio 30/70. Insulin aspart 30 mix is self-administered drug by SC injection 1-3 times per day before meal intake.
15827271|NCT04226105|Drug|NovoMix 30|1 ml of the NovoMix 30 contains 100 units soluble insulin aspart/protamine-crystallised insulin aspart in the ratio 30/70. Insulin aspart 30 mix is self-administered drug by SC injection 1-3 times per day before meal intake.
15827272|NCT04226092|Device|GPSkin Barrier Pro|This study is a pilot study to determine if this device produces similar readings than Aquaflux AF200 for TEWL/skin barrier on patients with and without atopic dematitis (AD).
15827273|NCT04226092|Device|Aquaflux AF200|This study is a pilot study to determine if this device produces similar readings than GPSkin Barrier Pro for TEWL/skin barrier on patients with and without atopic dematitis (AD).
15827274|NCT04226079|Diagnostic Test|Collection of exhaled breath|Collection of exhaled breath will be analyzed for specific volatile organic compounds which show different distribution between groups
15827275|NCT04226066|Biological|T601|"Part1: T601 is injected once (Day1). Dose range: 1E+7, 3E+7, 1E+8, 3E+8, 1E+9pfu.Trial cycle: Day1-21.
~For part1, 3+3 dose-escalation. After all patients of one dosage finished DLT evaluation, investigator judged that patients can benefit from treatment and no intolerable toxicity occurred, patients could receive maintenance treatment, and treatment plan is same as Cycle 1."
15827276|NCT04226066|Combination Product|T601+5-FC|"Part2: T601 is injected once (Day1). Dose range: MTD-2, MTD-1 and MTD of Part1. 5-FC is taken on Day5-18 for 14 consecutive days. Trial cycle: Day1-28.
~Part3: T601 is injected 3 times (Day1, 8, 15). Dose range: MTD-1 and MTD, or MTD-2 and MTD-1 of Part2. 5-FC is taken on Day5-7, Day12-14 and Day19-32. Trial cycle: Day1-46.
~Part4: Protocol revised based on results of Part1-Part3. Preliminary plan: 30 patients with gastric cancer, pancreatic cancer and hepatocellular cancer who have failed standard therapeutic options are enrolled (10 patients for each indication). Treatment plan is same as Part3.
~For part2 and part3, 3+3 dose-escalation. After all patients of one dosage finished DLT evaluation, investigator judged that patients can benefit from treatment and no intolerable toxicity occurred, patients could receive maintenance treatment, and treatment plan is same as Cycle 1."
15827310|NCT04225767|Combination Product|Calcium electroporation|Patients with cutaneous or subcutaneous malignant tumours will be treated with calcium electroporation, i.e. intratumoral injection of calcium followed by electroporation by electric pulses applied directly to the tumor.
15827338|NCT04225507|Other|CPAP Treatment|CPAP treatment for sleep apnea and CPAP education and adherence coaching.
15827573|NCT04223713|Procedure|Aortic valve replacement|Biological Prosthesis, Device: Edwards Perimount
15827277|NCT04226053|Other|Parenting, Child Development|The treatment group will consist of mothers that were randomly selected to receive Room to Grow services, which include three years of social and practical support for the mother and baby. The research-informed program model combines tailored, one-on-one sessions with an expert clinical social worker in-person every three months, provision of essential baby items including books, toys, clothing, and equipment (retail value of in-kind items over three years averages $10,000), and connections to vital community resources (e.g., housing, entitlements, child care, social services).
15827278|NCT04226040|Behavioral|DOW and illness perception|Acutely ill patients are exposed to a survey regarding their degree of worry and illness perception
15827279|NCT04226027|Behavioral|T2.coach|"T2.coach is a smartphone app for low-burden capture of diet and blood glucose (BG) levels and for reviewing past records, integrated with FitBit for captured of physical activity and sleep. All captured data are sent to the computational inference engine that uses machine learning methods and expert system to formulate personalized behavioral goals. Examples of behavioral goals include the following: For high carbohydrate breakfasts, reduce your carbs to be about 1 carb choice. Examples of 1 carb choice are 1 slice of whole wheat toast, 1 cup of oatmeal, or 1 apple. The T2.coach chatbot companion uses text messages to help individuals set goals that are consistent with evidence based guidelines for diabetes self-management, inferences on data captured with T2.coach, and their own preferences, as well as send individuals goal reminders and prompts for reflection on goal achievement."
15827280|NCT04226014|Procedure|Endoscopic ultrasound|Echo-endoscopy ultrasound is an examination that presents little risk. However, any medical act, exploration, intervention even conducted under conditions of competence and safety in accordance with current data of medicine and the regulations in force, conceals a risk of complications. In particular, esophageal perforations can occur. They are often favored by underlying lesions (tumor, diverticulum, anatomical variants ...). Other complications are possible such as cardiovascular, respiratory or infectious disorders, as with any anesthesia.
15827281|NCT04226001|Other|Quality of life questionnaire|Quality of life questionnaire
15827282|NCT04225988|Drug|Extended-release tacrolimus|Patients will receive the extended-release formulation of tacrolimus for maintenance immunosuppression.
15827283|NCT04225988|Drug|Immediate-release tacrolimus|Patients will receive the immediate-release formulation of tacrolimus for maintenance immunosuppression.
15827284|NCT04225975|Diagnostic Test|electroencephalogram|Within the 5 min after birth the electroencephalogram of the neonates will be recorded with the aid of a patch on the scalp
15827285|NCT04225975|Diagnostic Test|oxymetry|Within the 5 min after birth the cerebral oxymetry of the neonates will be recorded with the aid of a patch on the scalp
15827286|NCT04225962|Other|Intimate quality of life questionnaire|Preparation of an intimate quality of life questionnaire
15827287|NCT04225949|Other|survey 1|survey with one version of depiction
15827288|NCT04225949|Other|survey 2|survey with one version of depiction
15827289|NCT04225936|Drug|BMS-986263|Single Dose
15827293|NCT04225910|Drug|225Ac-PSMA|all the patients will receive 225Ac-PSMA RLT for 2 cycles. The dosage will be calculated according to 100KBq/kg body weight. The drug will be administered by vein injection.
15827294|NCT04225897|Drug|RV521|RV521 is an RSV F protein inhibitor administered orally
15827295|NCT04225897|Drug|Placebo|vehicle administered orally
15827296|NCT04225884|Other|DTx for pain software|Software with active intervention
15827297|NCT04225884|Other|Control software|Software without active intervention
15827298|NCT04225884|Other|Standard care|Pain medication
15827299|NCT04225871|Drug|zilucoplan (RA101495)|Daily subcutaneous (SC) injection
15827300|NCT04225858|Procedure|Omission of sentinel lymph node biopsy|No sentinel lymph node biopsy will be performed in clinically node-negative triple-negative or HER2-positive breast cancer patients with a radiologic complete response on MRI. Participants will be asked to complete quality of life questionnaires at baseline (prior to surgery), 6 months, 1, 3 and 5 years follow-up. A control group consisting of 100 clinically node-negative patients receiving standard treatment will be used to compare QoL scores. This group consists of patients that do not wish to participate in the experimental group (i.e., no sentinel node lymph node biopsy) or patients that are not eligible.
15827301|NCT04225845|Behavioral|Phone therapy|Weekly phone calls by lay trained personnel to deliver problem solving therapy.
15827302|NCT04225845|Behavioral|Cash transfer|One-time cash transfer of Rs.1000.
15827303|NCT04225832|Behavioral|CBT Coping Intervention|A cognitive behavior therapy group intervention for HIV-negative Latinx sexual minority men aimed at increasing HIV testing and prevention strategies.
15827304|NCT04225819|Dietary Supplement|Vitamin D3|Softgel capsules containing 5,000 IU cholecalciferol (Vitamin D3), sunflower oil, beef gelatin, glycerin, water
15827305|NCT04225819|Other|Placebo|Sfotgel capsules containing sunflower oil, beef gelatin, glycerin, water
15827306|NCT04225806|Device|BlueLeaf® Endovenous Valve Formation System (BlueLeaf System)|The BlueLeaf System is a single-use, disposable device designed to modify the vein wall to form one or more functional autogenous valves to improve the hemodynamics of the deep venous system treated.
15827307|NCT04225793|Drug|Eziklen®|"The Eziclen solution should be taken in the one-time use regimen in morning before procedure.
~Consumption of the full volume of the Eziklen® solution of the preparation and the additional amount of water or a clear liquid should be completed at least 2 hours and no later than 4 hours before the procedure."
15827308|NCT04225793|Drug|MoviPrep|"The Moviprep® solution should be taken in the one-time use regimen in morning before procedure.
~Consumption of the full volume of the Moviprep® solution should be completed at least 2 hours and no later than 4 hours before the procedure."
15827309|NCT04225780|Drug|Low-dose IL-2 and ganciclovir|If patients are eligible, which CMV-DNA are more than 10^3 copies, it will be randomly distributed in low-dose IL-2 and ganciclovir group, or ganciclovir group. Low-dose IL-2 is defined as 1 million IU per day subcutaneously.
15827337|NCT04225507|Behavioral|Diet and exercise coaching|All participants will receive diet and exercise goals and coaching.
15827311|NCT04225741|Behavioral|Training group|The single-session training lasted for approximately 40-45 minutes and was conducted in the training room of Sıtmapınarı family health center, as a suitable environment. The health belief model predicts the determinants of preventive health behaviors and explains inadequate participation in disease prevention and screening programs. Furthermore, this model not only explains behavior regarding screening, but also evaluates the cognitive factors that facilitate health-promoting behaviors.
15827312|NCT04225728|Drug|Iron Sucrose IV|"Intervention will consisted of the administration for the IV route.
~-The IV route in two doses will be diluted bolus injection of iron or normal saline at day 0 and day 14."
15827313|NCT04225728|Drug|Ferric polymaltose hydroxide complex IM|Intervention will consisted of the administration for the IM route. Drug will be given in two series of injection; the first series will began at day 0 and consist of administration of 300 mg of iron per day in intramuscular injection up to the half of the total dose and the second series will began at day 14 for the administration of the other half with the same scheme than the first.
15827314|NCT04225728|Other|Saline solution|100 ml i.v. of normal saline administered at Day 0 and at day 14.
15827315|NCT04225715|Drug|Nucleos(t)ide (NUC)|Nucleos(t)ide (NUC) will be administered orally
15827316|NCT04225715|Drug|CpAM (RO7049389)|CpAM (RO7049389) will be administered orally
15827317|NCT04225715|Drug|TLR7 (RO7020531)|TLR7 (RO7020531) will be administered orally
15827318|NCT04225715|Drug|siRNA (RO7445482)|siRNA (RO7445482) will be administered subcutaneously
15827319|NCT04225715|Drug|PEG-IFN|PEG-IFN will be administered subcutaneously
15827320|NCT04225689|Other|CD-TREAT diet|Dietary intervention
15827322|NCT04225663|Behavioral|Guided Meditation|Participants will meditate in response to the guidance provided by a trained meditation coach in person.
15827323|NCT04225650|Other|Pulmonology consultation|In case of functional respiratory signs, a consultation with a pulmonologist will be booked. At the end of this consultation, if the doctor deems it necessary, other investigations will be proposed and/or regular follow-up will be organised.
15827324|NCT04225637|Device|Miniscrew-Supported Maxillary Expander- Slow activation|A maxillary expander is supported on 4 palatal miniscrews. The appliance is activated slowly by turning the expansion screw once every other day to correct the transverse maxillary deficiency.
15827325|NCT04225637|Device|Miniscrew-Supported Maxillary Expander- Rapid activation|A maxillary expander is supported on 4 palatal miniscrews. The appliance is activated rapidly by turning the expansion screw twice per day to correct the transverse maxillary deficiency.
15827326|NCT04225624|Behavioral|Emotion Regulation Therapy - Attention Regulation (AR-ERT)|Participants will receive a total of eight 60 minute sessions (over 8 weeks) of individual, manual-based AR-ERT. This intervention aims to build attention regulation skills (i.e., the ability to flexibly shift and sustain attention) by teaching participants exercises for Orienting their attention and Allowing the presence of negative emotions. Participants are taught to apply these skills to counteract reactive perseverative thinking when negative emotions arise as well as proactively engage with emotion-laden situations that trigger repetitive negative thinking.
15827327|NCT04225624|Behavioral|Supportive Psychotherapy (SPT)|Participants will receive a total of eight 60 minute sessions (over 8 weeks) of individual, manual-based SPT. This intervention addresses factors that may affect participants' repetitive negative thinking symptoms (for example, relationships, work, stress), and teaches skills for managing challenges by improving self-esteem and positive coping skills.
15827328|NCT04225611|Drug|Dexamethasone|The investigators have developed a topically-applied corticosteroid-delivery system that has the potential to treat recurrent cystoid macular edema with fewer risks to patient, and more dose control. The system is comprised of a drug-polymer film that is completely encapsulated within the periphery of a hydrogel that is commonly used to make contact lenses.
15827329|NCT04225598|Drug|CAM2038|Patients will receive a 24 mg dose of injectable CAM2038 in the ED on Day 0.
15827330|NCT04225598|Drug|Buprenorphine Sublingual Product|"COWS ≥ 8: Patients will receive 4mg of SL-BUP for a COWS score of 8-12 (mild withdrawal). After 30-45 minutes if tolerated and no unanticipated adverse reactions, an additional 4mg can be administered for a total of 8mg in the ED. Patients presenting with moderate-severe withdrawal (COWS >≥ 13) will receive an initial dose of 8mg SL-BUP. All patients will receive a buprenorphine prescription and instructions for additional BUP doses to allow for up to a dose of 12mg if needed, and for 16mg each subsequent day until their scheduled follow up appointment for ongoing MOUD (medications for opioid use disorder).
~COWS 4-7: Patients will be provided with a uniform set of instructions to guide unobserved (home) induction. They will be prescribed doses of SL-BUP to allow them to take dose up to 12mg in the 24 hours after discharge. All patients will also receive a buprenorphine prescription for 16mg each subsequent day until their scheduled follow up appointment for ongoing MOUD."
15827331|NCT04225585|Behavioral|Targeted-PCST|skills training and experiential learning exercises
15827332|NCT04225585|Behavioral|General health education|general health education intervention that focuses on improving overall health
15827333|NCT04225572|Behavioral|Physical Therapy: Dependent on Patient's Needs|"Therapeutic exercise:
~ROM: Begin with passive upper extremity ROM and progress to active ROM.
~Strengthening: Progressive upper extremity resistive exercises starting with light weights.
~Aerobic: Select a suitable, individual aerobic exercise program (walking, yoga, etc.) Manual therapy
~Soft tissue mobilization, myofascial release, and stretching of identified tight and stiff tissue.
~Lymphedema treatment
~Manual lymph drainage: Gentle lymphatic massage to lymph nodes and vessels by PT for 1-2 weeks. Instruct patient in self MLD to perform 1-2×/day for 10 minutes during the remaining weeks.
~Compression therapy: Gradient compression bandaging for daily wear with activities and exercise for 1-2 weeks. Instruct in self compression bandaging or issue a compression garment to wear with exercise or activity, or with worsening symptoms of AWS (i.e. cording extends down arm) or lymphedema."
15827334|NCT04225533|Drug|SP16|All patients will receive a single dose of SP16
15827335|NCT04225520|Device|Cardiac resynchronization therapy ON|Implantation of a CRT device. Bi-ventricular pacing will be turned ON.
15827336|NCT04225520|Device|Cardiac resynchronization therapy OFF|Implantation of a CRT device. Bi-ventricular pacing will be turned OFF.
15827339|NCT04225481|Other|isolation of waste material and culturing with different supplement culture media|isolation of waste material and culturing with different supplement culture media
15827340|NCT04225468|Behavioral|ACL Opioid Exposure Reduction Program|Subjects will engage in a brief, educational which includes information about the appropriate use of opioid pain medication, exposure and tolerance, the definition of misuse and opioid-related harms, how to wean off medication, alternative pain management strategies, and appropriate disposal of leftover medication.
15827341|NCT04225455|Device|Glucose monitoring|"To compare the glucose monitoring CGMS Dexcom G6® with their usual self-glucose monitoring in pilots by way of assessing times achieved in safe Green flying range, in Amber flying range and in Red flying range as defined by the ARA.MED.330 diabetes protocol.
~[Green: 5-15 mmol/L; Amber: 4 to <5mmol/L and >15 to 20mmol/L; Red: <4mmol/L and >20mmol/L]"
15827342|NCT04225442|Other|Fatty meal to challenge the physiological chronobiome in healthy young and old|The intervention consists of a fatty meal
15827343|NCT04225429|Drug|Tazemetostat|800mg/dose taken orally twice every day.
15827344|NCT04225416|Other|Questionnaire/Structured Interview|No intervention
15827345|NCT04225403|Behavioral|Telephone-based motivational interviewing for smoking cessation|"The motivational brief intervention is known by the acronym 5 R and lasts about 5-10 minutes. It is an approach based on the principles of motivational interviewing and develops the intervention in five short steps:
~Relevance. Help patients identify why personal reasons may be relevant to quitting smoking.
~Risks. Help identify what negative consequences tobacco use has.
~Rewards. Help identify potential benefits of quitting smoking.
~Resistors. Help patients identify barriers to smoking cessation, which can often include fear of withdrawal symptoms, failure, wainweight, face social situations, etc.
~Repeat. Repeat the intervention at 3 months if you do not advance at the stage of change."
15827346|NCT04225390|Drug|Dacarbazine (DTIC)|Dacarbazine powder for IV solution
15827347|NCT04225364|Drug|camrelizumab|Participants will receive camrelizumab, 200mg, intravenously over 30 - 60 minutes, day 1 of every 3 weeks for 6 weeks. Discontinuation will be considered due to toxicity, withdrawal of consent, or end of study. Every 3-week treatment period was considered to be a cycle.
15827348|NCT04225364|Drug|Paclitaxel for injection (albumin-bound)|Paclitaxel for injection (albumin-bound): 260mg/m2(in total), ivgtt d1, d8, q3w，for 2 cycle
15827349|NCT04225364|Drug|Cisplatin|75mg/m2(in total), ivgtt d1-d3, q3w, for 2 cycles
15827350|NCT04225351|Procedure|MCAF+CM|CAF procedure + collagen matrix
15827351|NCT04225351|Procedure|MCAT+CM|Tunnel procedure + collagen matrix
15827352|NCT04225325|Combination Product|SYMTUZA|DESCOVY+REZOLSTA
15827353|NCT04225325|Combination Product|DESCOVY+DOLUTEGRAVIR|DESCOVY+DOLUTEGRAVIR
15827354|NCT04225325|Combination Product|SYMTUZA+DOLUTEGRAVIR|DESCOVY+REZOLSTA+DTG
15827355|NCT04225312|Drug|Personalized extended interval dosing of natalizumab|Personalized extended interval dosing of natalizumab based on natalizumab trough concentration
15827356|NCT04225312|Drug|Standard interval dosing|Standard interval dosing in control group and historic group
15827357|NCT04225299|Drug|TOOKAD®|TOOKAD® -VTP procedure will consist of an IntraVenous (IV) administration to patients using a 753nm laser light at a fixed power of 150mW/cm and a fixed energy at 200J/cm delivered through transperineal interstitial optical fibers. The needles are positioned in the prostate under ultra sound image guidance
15827358|NCT04225286|Other|Human breast milk|Intranasal human breast milk
15827359|NCT04225273|Device|Sculptra Aesthetic 8 ml and Lidocaine|Treatment of nasolabial folds
15827360|NCT04225260|Biological|botulinum toxin neuromodulator|A dose of QM1114-DP will be injected in the GL area and in the LCL area.
15827361|NCT04225247|Drug|Single Bond Universal|Single bond universal (by 3M ESPE) is a seventh generation bonding agents used as desensitizers in the present study.
15827362|NCT04225247|Drug|Bifluorid 12|it is a fluoride varnish by VOCO.
15827363|NCT04225247|Drug|Xeno V+|Xeno V+ (by Dentsply) is a seventh generation bonding agents used as desensitizers in the present study.
15827364|NCT04225234|Other|Financial incentives|"Depending on their level of participation or weight loss outcomes, participants will have the opportunity to receive between $60-$120 (over 12 months), on average, regardless of program assignment.
~Regardless of which incentive program that participants are randomized to, they will receive the incentaHEALTH weight loss program intervention. incentaHEALTH is an technology-supported multi-component coaching intervention for weight loss includes a website, objective weight assessment using HIPAA-compliant kiosks, daily social cognitive theory-based email and text message support, and online access to health coaches. The intervention encourages increased intake of fruit, vegetables, lean protein, and complex carbohydrates while monitoring portion sizes."
15827365|NCT04225221|Drug|Estradiol|During estradiol administration, 2mg of estradiol is given twice daily via oral capsule.
15827366|NCT04225221|Drug|Micronized progesterone|During progesterone administration, 200mg of progesterone is given twice daily via oral capsule.
15827367|NCT04225221|Drug|Leuprolide Acetate|Initial 3.75 mg intramuscular injection administered approximately Day 6 of menstrual cycle and then monthly thereafter for a total of 3 months.
15827368|NCT04225221|Drug|Placebo Oral Capsule|Placebo is administered during the addback phase when participants are not taking active medication. Placebo is given so that medication administration occurs throughout the entire 8-week addback period in order to blind participants to when and for how long they are on the active medication.
15827369|NCT04225208|Drug|[14C]-AZD4205, single 50 mg oral dose administrated on day 1|Each subject will receive 50 mg AZD4205 oral solution (free base equivalent) containing a nominal dose of 15 µCi [14C]- radiolabelled AZD4205 as a single administration .
15827370|NCT04225195|Drug|Amphotericin B cholesteryl sulfate complex for injection(ABCD)|"IC patients will only receive intravenous treatment with ABCD, with the longest course of treatment up to 42 days. ABCD will be administered once a day at a dose of 3-4 mg/kg. Visit plan: screening period (D-4 to D-1), baseline period (D1), treatment period and follow-up period (14±3days after the end of the last dose of ABCD).
~IA patients will be treated with ABCD for 4 weeks first, followed by oral administration of voriconazole. The total course of treatment should be at least 6 to 12 weeks. ABCD dosing regimen will be the same as that for IC patients. Visiting plan: screening period (D-4to D-1), baseline period (D1), treatment period and follow-up period."
15827371|NCT04225182|Device|traditional rehabilitation protocol|muscular strengthening protocol with traditional rehabilitation protocol without orthosis
15827372|NCT04225182|Device|with instrumented Orthosis|8 weeks of muscular strengthening with the orthosis connected to the phone app associated
15827373|NCT04225169|Other|Breathing exercises|The patient was taken to a quiet room and asked to lie on the bed. For the first 5 minutes, the researchers explained how the exercise is done with pictures and demonstrated it to the patient. The patient was asked to perform the exercise for 5 minutes under supervision by the researchers. If the patient performed DBE correctly, practice was discontinued. If not, the patient was asked to practice for another 5 minutes. If the patient still could not perform the exercise correctly at the end of this time, they were excluded from the sample. DBE was performed according to the Cleveland Clinic guideline as follows:
15827374|NCT04225156|Biological|efgartigimod|Intravenous infusion of efgartigimod
15827375|NCT04225143|Procedure|urostim bilateral|Treatment by bilateral neurostimulation of the tibial nerve
15827376|NCT04225143|Procedure|urostim unilateral|Treatment by unilateral neurostimulation of the tibial nerve
15827377|NCT04225130|Behavioral|Written Exposure Therapy -for Suicide|The first session will consist of the therapist educating the participant about common reactions to trauma and providing information regarding the rationale of WET-S as a treatment for PTSD. The participant will then be given general instructions for completing the trauma narratives, specific instructions for completing the first session, and will then complete the first (30 minutes) narrative writing session. Participants will be instructed to write about the same trauma experience during each session. The importance of delving into their deepest emotions surrounding the trauma event is emphasized. All WET-S sessions will take place in a private room and begin with the therapist reading the specific writing instructions for that session and then leaving the instructions with the participant while 30-minute writing session is completed.
15827378|NCT04225130|Behavioral|Treatment as Usual|The TAU condition consists of daily contact and patient centered care by the acute psychiatric inpatient unit provider team (e.g., psychiatrists, therapists, case managers, behavioral health techs). TAU includes initial stabilization, nurse case management, medication management, psychoeducation groups, and discharge planning. Patients engage with the provider team daily.
15827380|NCT04225104|Behavioral|Yogic breathing intervention|Yogic breathing will be completed while following a video provided by the investigative team. Breathing practices consist of slow, deep, relaxation breathing and are led by a certified yoga instructor.
15827381|NCT04225091|Dietary Supplement|Testing product|consume 1 bottle (50 mL) per day for 28 days
15827382|NCT04225091|Dietary Supplement|Blank|consume 1 bottle (50 mL) per day for 28 days
15827383|NCT04225078|Drug|Loperamide|Loperamide will be administered as a single oral dose at the expected therapeutic or supratherapeutic doses respectively.
15827384|NCT04225078|Other|Placebo|Matching loperamide placebo capsules will be administered orally.
15827385|NCT04225078|Drug|Moxifloxacin|Moxifloxacin tablets will be administered orally.
15827386|NCT04225065|Drug|Chlorhexidine|Chlorhexidine prep prior to surgery
15827387|NCT04225065|Drug|Betadine|Betadine prep prior to surgery
15827388|NCT04225052|Drug|YHP1903|YHP1903 Tab. 1mg
15827389|NCT04225052|Drug|Champix|Comparator Champix Tab. 1mg
15827390|NCT04225039|Drug|INCMGA00012|500mg IV neoadjuvant treatment; 500 mg adjuvant treatment
15827391|NCT04225039|Drug|INCAGN01876|300mg IV neoadjuvant treatment; 300 mg adjuvant treatment
15827392|NCT04225039|Drug|SRS|administered over the course of 3 consecutive business days (8 Gy x 3 fractions, one fraction per day, total dose 24 Gy).
15827393|NCT04225039|Procedure|Brain surgery|maximal safe surgical resection of the tumor.
15827394|NCT04225026|Drug|GC4419|90 mg, by 60-minute IV infusion, prior to each fraction of RT
15827395|NCT04225013|Diagnostic Test|Early kidney damage biomarkers|In the urine samples of these patients, a series of biomarkers of early kidney damage and / or predisposition to kidney damage will be measured
15827396|NCT04225013|Diagnostic Test|Predisposition to kidney injury biomarkers|In the urine samples of these patients, a series of biomarkers of predisposition to kidney damage will be measured
15827397|NCT04225000|Other|Exercise Group|Control group included 6 different exercises to treat participants having PFPS. These exercises included Semi squat with hip adduction and internal rotation, Quads isometrics, Straight Leg Raise (SLR) Hamstring Stretch, Terminal knee extension with elastic band , Adductor squeeze in crook lying (squeeze the ball), Hip abduction in standing with elastic band. These all exercises were advised to perform 3 x 15 Repetitions with 10 sec hold. This exercise protocol was for 4 weeks and 3 sessions per week.
15827398|NCT04225000|Other|Mobilization Group|"Experimental group included Anterior-Posterior (AP) tibiofemoral joint mobilization and all 6 exercises suggested controlled group for treating participants having PFPS; 3 sessions of mobilizations per week and total 4 weeks.
~These exercises included Semi squat with hip adduction and internal rotation, Quads isometrics, Straight Leg Raise (SLR) Hamstring Stretch, Terminal knee extension with elastic band , Adductor squeeze in crook lying (squeeze the ball), Hip abduction in standing with elastic band. Theses all exercises were advised to perform 3 x 15 Repetitions with 10 sec hold. This protocol was for 4 weeks and 3 sessions per week."
15827399|NCT04224987|Drug|Azithromycin|"Azithromycin will be administered as a directly observed dose in oral suspension form for children:
~Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
~For children 1-11 months of age, weight-based dosing will be used
~For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program"
15827400|NCT04224987|Other|Placebo|"Placebo will be administered as a directly observed dose in oral suspension form for children:
~Single-dose of 20mg/kg in children (up to the maximum adult dose of 1g)
~For children 1-11 months of age, weight-based dosing will be used
~For children 12-59 months of age, height-based dosing will be used via height-stick approximation as currently performed by Niger's trachoma program"
15827401|NCT04224974|Other|Usual Care|The usual care group will receive usual care of their acute leukemia at their centre but no formal psychological or palliative care intervention as part of this trial
15827428|NCT04224766|Procedure|costoclavicular Block 10ml bupivicaine 0.5%|transverse ultrasound imaging of the medial infraclavicular fossa to identify the cords of the brachial plexus at the costoclavicular space (CCS) then inject 10ml bupivicaine 0.5%
15827497|NCT04224285|Other|Dayzz app|Personalized sleep training app that evaluates sleep issues and offers a complete, holistic sleep improvement solution
15827402|NCT04224974|Behavioral|EASE-psy|"All patients randomized to EASE will receive tailored supportive psychotherapy over the initial 8 weeks following the diagnosis of acute leukemia. The psychotherapy will be delivered by trained therapists and combines elements of relational support, affect regulation, and trauma-informed cognitive behavioural therapy (CBT).
~-EASE-phys: All patients randomized to EASE will receive weekly symptom screening during the initial inpatient treatment period (typically 4 weeks) with triggered referral to early palliative care (symptom control) to help manage moderate to severe physical symptoms based on a philosophy of multidisciplinary care and comprehensive assessment of symptoms."
15827403|NCT04224961|Device|Respiratory Muscle Training|Two commercially available pressure-threshold RMT devices that utilize a spring-loaded flange to provide resistance against inspiration and expiration independent of respiratory flow rate will be used to provide the necessary range of resistance. Each participant will use two RMT devices, one for IMT and one for EMT.
15827404|NCT04224948|Device|PET MRI scan|"Standard of care includes a baseline PET-CT and conventional CT after 2 cycles of neoadjuvant chemotherapy, and after 5-6 cycles, of neoadjuvant chemotherapy, as per current practice/ standard of care.
~Patients that enroll in the trial will receive two additional PET MRI scans- one at baseline and one after 1 cycle of chemotherapy"
15827405|NCT04224935|Procedure|Leukocyte Platelet rich fibrin membrane|the use of Leukocyte Platelet rich fibrin as grafting materials for treatment of recession
15827406|NCT04224922|Drug|Paclitaxel|
15827407|NCT04224922|Drug|Carboplatinum|
15827408|NCT04224922|Drug|Epirubicin|
15827409|NCT04224922|Drug|Cyclophosphamide|
15827410|NCT04224909|Diagnostic Test|Video Head Impulse Test|Diagnosis of dysfunction of the semicircular canals using the vHIT
15827411|NCT04224896|Diagnostic Test|UPPER ENDOSCOPY|UPPER ENDOSCOPY
15827412|NCT04224883|Procedure|Continuously feeding|Daily amount of feeding were continuously pumped for 24 hours. Enteral nutrition preparations pumping scheme: the initial pumping speed is 50ml/h, and gastric residual volumes(GRV) is checked every 4 hours. If it can be tolerated, the velocity of the pumping can be increased by half of the original speed.If it is not tolerable, the speed of the pumping is reduced by half on the original speed. GRV<200mL were considered markers of good tolerance.Feeding intolerance was defined as GRV>200 mL.
15827413|NCT04224883|Procedure|16-hours feeding|Daily amount of feeding were continuously pumped for 24 hours.Enteral nutrition preparations pumping scheme: the initial pumping speed is 50ml/h, and gastric residual volumes is checked every 4 hours.If it can be tolerated, the velocity of the pumping can be increased by half of the original speed.If it is not tolerable, the speed of the pumping is reduced by half on the original speed. GRV<200 mL were considered markers of good tolerance. Feeding intolerance was defined as GRV>200 mL.
15827414|NCT04224883|Procedure|intermittent feeding|Daily amount of feeding were divided into four meals, each meal are pumped within 60mins through stomach tube. Enteral nutrition preparations pumping scheme: the initial pumping speed is 250ml/h, and gastric residual volumes is checked before each intermittent feeding. If it can be tolerated, the velocity of the pumping can be increased by half of the original speed.If it is not tolerable, the speed of the pumping is reduced by half on the original speed. GRV<200 mL were considered markers of good tolerance. Feeding intolerance was defined as GRV>200 mL.
15827415|NCT04224857|Drug|AMT-101|Single or daily dosing at doses A, B, C, D, E, F
15827416|NCT04224857|Drug|Placebos|Single or daily dosing at doses A, B, C, D, E, F
15827417|NCT04224844|Other|Erector spinae plane block|The block will be performed before the surgery. The spinous process of T2 or T3 wil be identified by an ultrasound guide, with the probe positioned longitudinally. A block needle will be inserted in the caudo-cephal direction. After the injection site is confirmed by 3 ml of physiological solution and correct position of the needle tip is confirmed, bupivacaine will be injected. The patients assigned to this group will also receive an intravenous patient-controlled analgesia device containing tramadol postoperatively.
15827418|NCT04224844|Other|Control group|Control group will receive only patient-controlled analgesia device containing tramadol. No block will be performed.
15827419|NCT04224831|Combination Product|Source of growth factors: autologous platelet-rich plasma (aPRP) + repetitive electromagnetic stimulation for iontophoresis|"Autologous platelet rich plasma is containing many types of growth factors (GFs) such as epithelial growth factor (EGF), fibroblast growth factor (FGF), transforming growth factor (TGF), nerve growth factor (NGF), platelet-derived growth factor (PDGF), and insulin-like growth factor (IGF).
~Repetitive high frequency electromagnetic stimulation (rEMS) creates a stimulated focus in the tissue by increasing blood flow and platelets at the capillary level. Electromagnetic stimulation along with growth factors has shown synergetic effects toward enhanced epithelial integrity and neural functions. With the addition of possible iontophoresis effects in the rEMS, the passage of the various active molecules can be augmented at the tissue level thereby increasing the widespread effect of the GFs in the damaged choroidal and outer retinal microenvironment."
15827420|NCT04224818|Drug|Dual trigger|Dual trigger: human Chorionic Gonadotropin (Choriomon 10,000 IU subcutaneous once) + Gonadotropin-Releasing Hormone agonist (Triptorelin 0.3 mg subcutaneous once)
15827421|NCT04224818|Drug|hCG (standard)|human Chorionic Gonadotropin (Choriomon 10,000 IU subcutaneous once)
15827422|NCT04224805|Device|Bone-borne CAD/CAM splint|3D printed splint that repositions the maxilla with the zygomatic buttress as a reference.
15827423|NCT04224805|Device|3D interocclusal conventional splint|Interocclusal splint that relies on the centric relation of the condyle as well as occlusion.
15827424|NCT04224792|Other|Center-based exercise program|A routine individualized exercise prescription and supervised exercise sessions at a minimum of once per week for 11 weeks with an exercise prescription updated monthly.
15827425|NCT04224792|Other|Home-based exercise program|A one-time supervised exercise session with Cardiac Rehabilitation staff and a routine individualized exercise prescription for exercises to do at home. Additionally, weekly telephone followup calls by a clinical exercise physiologist for 11 weeks consisting of an exercise tip.
15827426|NCT04224779|Biological|Biological collection|The biological collection will include samples of blood samples collected at different times but also tumoral biopsy before the surgery.
15827427|NCT04224766|Procedure|Suprascapular Nerve Block with 5ml bupivicaine 0.5%|The patient lies supine with the head turned to the contralateral side to the block. Using a linear high-frequency ultrasound probe, the proximal suprascapular nerve is visualized before it turns toward the suprascapular notch. It is blocked using 5mL of bupivicaine 0.5%.
15827429|NCT04224766|Procedure|Interscalene Brachial Plexus Block 15ml bupivicaine 0.5%|The patient lies supine with the head turned to the contralateral side to the block. Using a linear high-frequency ultrasound probe, the interscalene groove is visualized along with the roots of the brachial plexus. The block is performed with 15mL of bupivacaine 0.5%.
15827430|NCT04224753|Device|INVSENSOR00027|Investigational, noninvasive sensor that will be placed on the subject's chest. INVSENSOR00027 detects falls for each subject.
15827431|NCT04224740|Drug|Pembrolizumab|Patients will receive pembrolizumab at the dose of 200mg IV Q3W with maximum duration of 2 years (34 cycles-counting the part combined with chemotherapy)
15827432|NCT04224740|Drug|Standard of care therapy|Ciplastin 70mg/m² IV D1(or carboplatin AUC 5) plus 5-Fluouracil 1000mg/m²/day IV( continuous infusion on Days 1-4) Q3W for 6 cycles
15827433|NCT04224727|Behavioral|Group Commitment Contract|A group contract where the primary individual, who will be tracked by the study, can invite between 1 and 3 peers to join the contract and form their group. To initiate a quit smoking contract, a user must choose: the duration in weeks during which the contract members need to quit smoking; the stake each member must put in; and, optionally, to allow other members to have the power to invite other people to join the group.
15827434|NCT04224727|Behavioral|Individual Monetary Rewards|Individuals eligible for a $100 monetary reward (incentive) following biochemically-verified smoking cessation.
15827435|NCT04224727|Behavioral|Individual Commitment Contract|Individuals will have the opportunity to create an individual commitment contract to quit smoking. They will have the option to set money at stakes and how many weeks the contract will last.
15827436|NCT04224727|Other|Information|"In the initial survey, participants will receive additional information treatments on the likelihood of success of the different incentives and contracts, with the goal of shifting naives to sophisticates."
15827437|NCT04224714|Combination Product|FFR|FFR measurement: Pressure guid wire(radianalyzer Xpress 12711) is produced in Switzerland. After the pressure of the aorta and the pressure guide wire is balanced, Send the pressure guide wire to the distal part of the lesion(more than 20 mm away from the lesion) . Adenosine is injected into the vein,then,record the FFR index 3 times and take the average value as the final measurement index.
15827438|NCT04224701|Biological|BG505 SOSIP GT1.1 gp140 Vaccine, Adjuvanted|30 µg
15827439|NCT04224701|Biological|BG505 SOSIP GT1.1 gp140 Vaccine, Adjuvanted|300 µg
15827440|NCT04224701|Biological|Placebo|Tris NaCl Diluent
15827443|NCT04224675|Drug|Atenolol|Captopril versus atenolol to prevent expansion rate of thoracic aortic aneurysms
15827444|NCT04224662|Other|No intervention|There is no intervention for this study
15827445|NCT04224649|Device|HARA Filler(Hyaluronic acid Filler)|The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).
15827446|NCT04224649|Device|Restylane® Lidocaine|The same participants received the experimental device and the active comparator device at the same time (left and right sides of face).
15827447|NCT04224636|Combination Product|Atezolizumab Injection, Bevacizumab Injection|Atezolizumab and Bevacizumab will be administered prior to or in combination with TACE
15827448|NCT04224623|Behavioral|Raising Well at Home|The Raising Well at Home intervention was delivered via 3 core home visits designed to be delivered every 4-6 weeks, with additional support via text or phone over 6 months. The home visits were designed to engage the whole family, build skills, and promote changes in the home environment to support lifestyle behavior change. These essential behaviors focused on reducing sugary beverage intake, promoting appropriate portion sizes, improving fruit and vegetable intake, increasing walking and reducing screen time/sedentary activity.
15827449|NCT04224597|Diagnostic Test|ultrasonography|all participants will be determined by ultrasonography.
15827450|NCT04224584|Drug|Duloxetine|Duloxetine will be administrated with a two weeks up titration followed by a 10 weeks full treatment (60 mg/daily) and finalized by a two weeks discontinuation.
15827451|NCT04224584|Drug|Placebo oral tablet|Placebo will act as a control for duloxetine.
15827452|NCT04224571|Drug|Bortezomib Injection|Bortezomib: patients with BM relapsed, add for 4 doses on D1,4,7, 11 in induction; dosage 1.3 mg/m2/dose as per parenteral;
15827453|NCT04224571|Drug|rituximab injection|Add rituximab in patients with CD20 positive ALL, rituximab: 6 doses of on D8,11of induction, D1,15 of consolidation1 and 2 with dosage 375 mg/m2 as parenteral (Terminated in Oct 2020)
15827454|NCT04224558|Drug|Mesna|"Stem Cell Mobilization: Infused according to institutional guidelines;
~Post-PBSC Infusion Conditioning: Mesna provided with Cytoxan according to institutional protocol."
15827455|NCT04224558|Drug|Cyclophosphamide|"Stem Cell Mobilization:
~Cyclophosphamide (CY) infused intravenously over 1 hour: 50 mg/kg (25 mg/kg/day on 2 consecutive days)"
15827456|NCT04224558|Drug|Filgrastim|"Stem Cell Mobilization: Filgrastim (G-CSF) 10 mcg/kg SC will start 5 days after the last dose of CY and will end the day before the last leukapheresis;
~Post-PBSC Infusion Conditioning: Filgrastim administered intravenously 5 mcg/kg IV starting day + 5, continue until ANC of >1000/μL"
15827457|NCT04224558|Procedure|Apheresis catheter placement|Subjects will require placement of an Apheresis catheter by Intervention Radiologists on the day of collection of stem cells.
15827458|NCT04224558|Procedure|Leukapheresis|Leukapheresis will be performed on a continuous flow separator machine according to institutional guidelines to target 3-8 x 10^6 CD34+ cells/kg body weight.
15827459|NCT04224558|Drug|Fludarabine|Preparative/Conditioning Regime Fludarabine given as 30 mg/m2 per dose x 4 days, beginning on day -6.
15827460|NCT04224558|Drug|Methylprednisolone|Preparative/Conditioning Regime r-ATG pre-medication according to institutional guidelines
15827461|NCT04224558|Drug|Diphenhydramine|Preparative/Conditioning Regime r-ATG premedication according to institutional guidelines
15827462|NCT04224558|Drug|Acetaminophen|Preparative/Conditioning Regime r-ATG premedication according to institutional guidlines
15827463|NCT04224558|Drug|anti-thymocyte globulin (rabbit)|Preparative/Conditioning Regime r-ATG administered intravenously: 2.5 mg/kg/dose IV over 6 hours on specified days (day -6,-4,-2); ); total 3 doses=7.5 mg/kg.
15827498|NCT04224272|Drug|ZW25 (Zanidatamab)|Administered intravenously
15827499|NCT04224272|Drug|Palbociclib|Administered orally
15827464|NCT04224558|Drug|lymphocyte immune globulin|Preparative/Conditioning Regime In patients who develop severe allergic reactions to rATG (Thymoglobulin), it may be substituted by horse ATG (hATG, ATGAM, Pharmacia & Upjohn, Kalamazoo, MI). The recommended dose of hATG is 25 mg/kg/day for 3 doses.
15827465|NCT04224558|Biological|Peripheral Blood Stem Cell Infusion|PBSC (peripheral blood stem cell) infusion on day 0 as per institutional guidelines.
15827466|NCT04224558|Drug|Cytoxan|Post-PBSC Infusion Conditioning Cytoxan infused intravenously: 50mg/kg/day x 2 days. Infused over 2 hours with adequate hydration or according to institutional guidelines.
15827467|NCT04224545|Drug|Colchicine|Colchicine at a dose of 1 mg a day before surgery, 2, 3, 4, 5 days after surgery.
15827468|NCT04224545|Drug|Placebo|Placebo started a day before surgery, 2, 3, 4, 5 days after surgery.
15827469|NCT04224532|Procedure|Pneumoperitoneum Timing (Before Positioning)|Before Reverse Trendelenburg Position
15827470|NCT04224532|Procedure|Pneumoperitoneum Timing (After Positioning)|After Reverse Trendelenburg Position
15827471|NCT04224519|Biological|sIPV batch 1|Type I 30 DU, Type II 32 DU, Type III 45 DU
15827472|NCT04224519|Biological|sIPV batch 2|Type I 30 DU, Type II 32 DU, Type III 45 DU
15827473|NCT04224519|Biological|sIPV batch 3|Type I 30 DU, Type II 32 DU, Type III 45 DU
15827474|NCT04224506|Other|No intervention|There is no intervention for this study.
15827475|NCT04224493|Drug|Tazemetostat|Tazemetostat RP3D (tablets) administered PO twice daily in continuous 28-day cycles for 12 cycles.
15827476|NCT04224493|Drug|Placebo oral tablet|Placebo tablets administered PO twice daily in continuous 28-day cycles for 12 cycles.
15827477|NCT04224493|Combination Product|Lenalidomide|Lenalidomide 20 mg capsules (if creatinine clearance ≥60 mL/minute) or 10 mg capsules (if creatinine clearance <60 mL/minute), administered PO QD on days 1 to 21 for 12 cycles.
15827478|NCT04224493|Combination Product|Rituximab|Rituximab 375 mg/m2 IV on days 1, 8, 15, and 22 of cycle 1; then on day 1 of cycles 2 to 5.
15827479|NCT04224480|Drug|Pembrolizumab|200mg of intravenous infusion every 3 weeks
15827480|NCT04224467|Other|Intravenous ICG and Real-Time Near-infrared Imaging|Patients will be intravenously injected ICG (Yichuang Pharmaceutical Limited Liability Company, Dandong, China) at a dose of 2-5 mg per kg of body weight before surgery or 0.25-0.5 mg per kg of body weight during surgery. Then real-time near-infrared imaging will be conducted during surgery.
15827481|NCT04224454|Other|Questionnaire|"Questionnaire was adapted from questionnaires used by the French national agency Institut de Veille Sanitaire to study vaccination coverage and were completed with the assistance of one fellow to limit missing data."
15827482|NCT04224441|Drug|Chlorpromazine Pill|The experimental treatment involves the combination of chlorpromazine to the standard treatment with temozolomide solely in the adjuvant phase (after radio-chemotherapy, temozolomide for 5 days every 28, at a dose of 150-200 mg/mq for 6 cycles) of the Stupp protocol. Chlorpromazine will be administered at a dose of 50 mg/day concomitantly with the adjuvant treatment with temozolomide
15827483|NCT04224428|Drug|Fexofenadine Pill|fexofenadine tablets 60 mg once daily will be taken for six months
15827484|NCT04224428|Drug|Placebo oral tablet|lactose oral tablet
15827485|NCT04224415|Drug|C225+CPT-11|"Patients will receive Systemic C225+CPT-11 every 14 days:
~C225 500 mg/m2 IV over 90 minutes on Day 1; Irinotecan 180 mg/m2 IV on Day 1"
15827486|NCT04224402|Drug|mFOLFORINOX|Patients will receive mFOLFIRINOX every 2 weeks: Oxaliplatin 65 mg/m2 IV over 3 hours on Day 1; Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; Leucovorin(l-LV) 200 mg/m2 IV over 2 hours on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion.
15827487|NCT04224389|Procedure|transoral resection|The technique of transoral surgery will be left to the choice of the surgeon according to the equipment and the experience of the team and will be gathered. The options are: transoral surgery robot-assisted, endoscopic laser transoral surgery, transoral laser surgery classical instruments. The exact description of the resected area will be collected. of the cross-sections will be made for extemporaneous analysis if necessary in lateral margins and deep until complete excision.
15827488|NCT04224389|Radiation|IMRT|Intensity modulation radiotherapy (RCMI or IMRT) will be performed using techniques static or rotational (arctherapy, tomotherapy). Restraint is recommended with thermoformed mask
15827489|NCT04224376|Device|App based Serious Gaming with the Genu Sport knee trainer|The Genu Sport knee trainer has a strength monitoring unit with three integrated sensors which is placed in the popliteal area and a tablet with the application which allows to transfer the raised force into the game modus. Each training session in our study takes around 5 minutes and is performed autonomously by the patient in his bed with 45° degrees of upper body evaluation while the patient holds the tablet in both hands. By simply pushing his knee downward onto the measuring unit the patient can apply the force.
15827490|NCT04224363|Procedure|staining from cervical esophagus to esophagogastric junction|This group patients were given Lugol's solution staining from cervical esophagus to esophagogastric junction （downward）during chromemdoscopy.
15827491|NCT04224363|Procedure|staining from esophagogastric junction to cervical esophagus|This group patients were given Lugol's solution staining from esophagogastric junction to cervical esophagus（upward）during chromemdoscopy.
15827492|NCT04224350|Drug|TacroBell SR cap.|"Orally, once-daily in the morning
~After first dose 0.2mg/kg, check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 3~12ng/ml for 0 to 3months and then at 3~8ng/ml for 3 to 6months of study treatment."
15827493|NCT04224350|Drug|Tacrolimus cap.|"Orally, twice a day in the morning and night
~After first dose 0.1mg/kg, check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 7~12ng/ml for 0 to 3months and then at 5~8ng/ml for 3 to 6months of study treatment."
15827494|NCT04224337|Drug|Durvalumab + doxorubicin + ifosfamide|Durvalumab: 1500mg via IV infusion on day 1 Q3W for 4 cycles followed by durvalumab monotherapy 1500mg via IV infusion Q4W for up to a maximum 12 months Doxorubicin 20mg/m2 via IV infusion on day 1 to day 3 Q3W (up to 4 cycles) Ifosfamide: 1.5g/m2 (with mesna) via IV infusion on day 2 to day 4 Q3W (up to 4cycles)
15827495|NCT04224324|Procedure|Tonsillectomy and Adeniodectomy|pediatric patients undergoing tonsillectomy and adenoidectomy
15827496|NCT04224311|Biological|Menactra|0.5 mL dosage of Menactra will be administered by intramuscular injection in the deltoid muscle on day 0.
15827500|NCT04224272|Drug|Fulvestrant|Administered as an intramuscular injection
15827501|NCT04224259|Procedure|Ultrasound pre-scan|Before cannulation, use ultrasound to mark the position of right internal jugular vein
15827502|NCT04224259|Procedure|Landmark guidance|The traditional landmark-guided technique for internal jugular vein cannulation, including recognizing the sternocleidomastoid muscle and palpating the carotid artery
15827503|NCT04224246|Drug|Gamma Hydroxybutyrate|Gamma-OH® will be administered intravenously at a dose of 20 mg/kg/h for 6 hours
15827504|NCT04224233|Other|Home-based physical activity programme|iLiFE is a 12-week individualised programme, adapted to the participants' needs and preferences. This programme will be conducted in participants' home and include everyday tasks to train endurance, balance, flexibility and strength. The intervention incudes face-to-face sessions and phone calls. Face-to-face sessions aim to adapt activities to everyday tasks, increase frequency and/or intensity, monitor progress, clarify doubts, motivate higher daily energy expenditure and manage expectations. Phone-calls aim to clarify doubts and to monitor patients' motivation/evolution, following a motivational interview. At the start of the program, the physiotherapist will be present at all sessions (3 face-to-face sessions/week), but these face-to-face visits will decrease over time. Patients will also receive a personalised manual (iLiFE manual) with activities to do in their everyday tasks.
15827505|NCT04224233|Other|Usual care|Participants will receive a leaflet with exercises and PA recommendations.
15827506|NCT04224220|Other|Adult Medical Care Coordination|Nurse-based support that includes a home visit and follow-up coaching telephone calls to monitor patient status and ability to self-manage symptoms.
15827507|NCT04224220|Other|Remote Patient Monitoring|Nurse-based support and coaching that incorporates the use of technology to monitor patient status and ability to self-manage symptoms.
15827508|NCT04224207|Biological|Wharton's jelly derived mesenchymal stem cell|The mesenchymal cells that were used in this study were isolated from Wharton's jelly of the umbilical cord that was collected allogenicly from a single donor with the mother's consent. All cell preparation and cultivation procedures were conducted in a current Good Manufacturing Practice (cGMP) accredited laboratory (Onkim Stem Cell Technologies, Turkey).Cells were solubilized from cryopreservation before being made ready for injection. Average cell viability for each treatment was over 90.0% and each patient received cell numbers between 2-6x106 in a 1.5 ml saline solution .
15827509|NCT04224194|Combination Product|Adalimumab|Combined product as Drug is delivered through an autoinjector pen on which real-life patient handling experience is assessed.
15827510|NCT04224181|Radiation|Cardiac PET|A scan examining blood flow to the heart
15827511|NCT04224181|Radiation|99mTc-tilmanocept SPECT/CT|A scan to look at inflammation in the arteries
15827512|NCT04224181|Radiation|Contrast Enhanced Coronary and Aortic Computed Tomography Angiography|A scan of the heart and surrounding blood vessels
15827513|NCT04224168|Dietary Supplement|Green Beans|Please see arm group Green beans for description
15827514|NCT04224168|Dietary Supplement|Liquid Pectin|Please see arm group liquid pectin for description
15827515|NCT04224155|Device|enVista MX60EFH trifocal intraocular lenses (IOLs)|enVista MX60EFH trifocal intraocular lenses (IOLs) implanted bilaterally
15827516|NCT04224155|Device|enVista MX60E monofocal intraocular lenses (IOLs)|enVista MX60E monofocal intraocular lenses (IOLs) implanted bilaterally
15827517|NCT04224142|Dietary Supplement|PKU sphere|"PKU sphere is a Food for Special Medical Purposes (FSMP). This product is for use in the dietary management of phenylketonuria (PKU).
~It is a powdered, low phenylalanine medical food containing a balanced mix of GMP, essential and non-essential amino acids, carbohydrate, fat, vitamins, minerals, and DHA.
~It is available in 27g sachets providing 15g PE and contains 28mg Phe and 35g sachets providing 20g PE and contains 36mg Phe."
15827518|NCT04224116|Drug|Tranexamic acid injection|to receive tranexamic acid (25mg/kg) in bolus at induction followed by 2mg/kg/h in continuous infusion until the end of the act.
15827519|NCT04224116|Drug|SSI|Serum Salin isotonic injected
15827520|NCT04224103|Drug|Inhaled nitric oxide|"Stage 1: Patients in whom VA ECMO is being initiated will be invited to participate. Hemodynamic, echocardiographic, and biochemical parameters will be measured immediately prior to iNO administration, and thirty minutes after initiation. After six hours, hemodynamic, echocardiographic, and biochemical parameters will be re-assessed after which iNO will be weaned. All parameters will be re-evaluated 30 minutes after iNO discontinuation.
~Stage 2: iNO will be re-initiated 30 minutes prior to the ECMO weaning trial. Hemodynamic, echocardiographic, and biochemical parameter will be recorded immediately prior to iNO administration and then at 30 minutes prior to the ECMO weaning trial. When ECMO weaning is unsuccessful, these parameters will be recorded immediately prior to re-initiation of full flow VA ECMO and 30 minutes thereafter. If successful, data will be collected after the wean and after iNO discontinuation."
15827521|NCT04224090|Diagnostic Test|Echocardiographic assessment of coronary arteries origin and proximal course|Echocardiographic assessment of CAA utilizing 4 specific echocardiographic acoustic windows: parasternal short-axis (PSAX), parasternal long-axis (PLAX), apical 4/5-chambers views.
15827522|NCT04224077|Diagnostic Test|Optimisation of DTI sequences|Optimisation of DTI sequences in the study of lumbar roots by MRI
15827523|NCT04224064|Diagnostic Test|Blood sampling|Blood samples will be performed in fasted state for the controls and the patients. A single sample will be made in healthy subjects and several samples in patients: one before induction before surgery and then the second 4 weeks after surgery (+/- 1 week), then every 3 months for 18 months.
15827524|NCT04224051|Drug|Metformin|Metformin target dose 2 g daily
15827525|NCT04224051|Other|Standard care|Abdominal aortic aneurysm surveillance
15827526|NCT04224038|Other|The Inspire Bio-resource Research Platform for Healthy Aging|Several follow-up visits will be undertaken during the 10-year time frame of this project. Some of these visits are not regularly scheduled and will be conditioned by the remote monitoring of intrinsic capacity (IC) and the onset of other major clinical conditions. Other visits correspond to the regularly scheduled (yearly or every two years (biannual visits), depending on the outcome measures) waves of data collection.
15827527|NCT04224025|Other|exercise and respiratory therapy|three weeks in-Hospital exercise Rehabilitation program with continuation at home (total 15 weeks).
15827528|NCT04224012|Other|Exercise and respiratory therapy|Three weeks in-Hospital Rehabilitation program with continuation of exercise Training at home
15827529|NCT04223999|Procedure|Skullremodeling surgery|"Strategically placed cranial burrholes in order to improve the TTField dose focally in the tumor."
15827530|NCT04223999|Other|Control|Tumor treating fields combined with best medical treatment.
15827531|NCT04223986|Diagnostic Test|Ultrasound|decide between the need for intervention or not (Percutaneous coronary intervention)
15827532|NCT04223986|Diagnostic Test|Troponin- T quick test|Quick test for Troponin T blood assessment
15827533|NCT04223973|Device|Medtrum A7+ insulin Pump|Use of the Medtrum pump during 3 months in combination with a CGM
15827534|NCT04223973|Biological|Lab A1C|Measure of Lab A1C at baseline and end of study
15827540|NCT04223947|Procedure|DIGESTIVE ENDOSCOPY|DIGESTIVE ENDOSCOPY
15827541|NCT04223934|Other|optima4BP|"optima4BP establishes a no gaps computational framework in determining the most effective treatment change that can optimize a patient's HTN management towards BP Target. All possible drug combination options available through the 16 anti-HTN drug classes and subclasses are quantitatively evaluated in the context of 5 actions: add a drug, remove a drug, replace a drug, increase a drug dose, and decrease a drug dose. The pharmacological intervention efficacy ranking is computed and the highest ranked treatment recommendation is selected for consideration by the treating physician."
15827542|NCT04223921|Other|Comparison of patient's medicines|"Comparison of patient's medicines:
~between patient's discharge from hospital and one month after this discharge (acute geriatric care unit)
~between patient's admission and discharge from hospital (acute geriatric care unit"
15827543|NCT04223908|Other|observational : questionnaries for assessment of health burden|The French IN-FOCUS study was designed to capture current and retrospective data in FCS or MCS. Patients were called by the participating centers and were proposed to answer a paper questionnaire or to connect to a web-based questionnaire The questionnaire was divided into sections specifically assessing various domains of their experience: demographic data, signs, symptoms and complications of the disease, healthcare circuit, management, relationship with healthcare providers, and burden of the disease on daily life. (Details are available as supplementary material S1). The questionnaire focused on symptoms because the interest of quality of life assessment tools is debated in rare diseases with episodic manifestations. Indeed, most of these tools refer to a limited recall period.
15827544|NCT04223895|Drug|CKD-386 Formulation 1|A single oral dose of 1 tablet under fasting conditions for each period
15827545|NCT04223895|Drug|CKD-386 Formulation 2|A single oral dose of 1 tablet under fasting conditions for each period
15827546|NCT04223895|Drug|D012, D326 and D337|A single oral dose of 3 tablets(D012, D326 and D337) under fasting conditions for each period
15827547|NCT04223882|Behavioral|Management of Stress|"Psychoeducation:
~Coronary artery disease, Percutaneous Coronary Intervention, traditional risk factors and emotional stress.
~Stress: physiology, triggers, triad (thinking, emotion, action).
~Skills training:
~Identify warning signs - signs and symptoms; Monitoring of irrational automatic thoughts generating alternative interpretations of situations or unrealistic thinking patterns (Dysfunctional Thinking Records Sheet).
~Self-control for stress management:
~Assertiveness training, problem solving. Thought-stopping technique, designed for dysfunctional thoughts, such as, I won't do it, It won't work.
~Stress Relief / Control Techniques:
~Diaphragmatic Breathing: Expansion of the abdomen rather than the chest when breathing.
~Progressive Muscle Relaxation: Maximize tension and alternately relax the muscles (legs, abdomen, chest, arms and face)."
15827548|NCT04223869|Other|non-surgical periodontal treatment|scaling and root planing were performed
15827554|NCT04223843|Drug|Tiotropium + olodaterol|Oral Inhalation
15827555|NCT04223843|Drug|Placebo|Oral Inhalation
15827556|NCT04223830|Device|Exalt Model D Single-Use Duodenoscope|Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device.
15827557|NCT04223817|Device|7.0 T RMI|Single 7.0 Tesla MRI of both hands in the same time
15827558|NCT04223804|Drug|ABBV-181|Intravenous (IV) infusion
15827559|NCT04223804|Drug|Placebo|Intravenous (IV) infusion
15827560|NCT04223791|Drug|DOR/ISL|100 mg DOR/ 0.75 ISL FDC tablet taken orally once daily
15827561|NCT04223791|Drug|BIC/FTC/TAF|50 mg BIC, 200 mg FTC, and 25 mg TAF combined in a single tablet, taken orally once daily
15827562|NCT04223791|Drug|Placebo to BIC/FTC/TAF|Placebo to BIC/FTC/TAF in a single tablet taken orally, once daily
15827563|NCT04223791|Drug|Placebo to FDC DOR/ISL|Placebo to FDC DOR/ISL in a tablet taken orally, once daily
15827564|NCT04223778|Drug|DOR/ISL|A FDC of 100 mg DOR/ 0.75 mg ISL taken in tablet form, orally, once daily
15827565|NCT04223765|Drug|CAR.k.28|Three dose levels will be evaluated: Dose level 1 (5x10^5 cells/kg), Dose level 2 (1x10^6), and dose level 3 (2x10^6 cells/kg).
15827566|NCT04223765|Drug|Fludarabine|30 mg/m^2/day IV for 3 consecutive days
15827567|NCT04223765|Drug|Cyclophosphamide|500 mg/m^2/day IV for 3 consecutive days
15827568|NCT04223765|Drug|Bendamustine|70 mg/m^2/day administered over 3 consecutive days.
15827569|NCT04223752|Drug|Ceftolozane/Tazobactam|"Participants 12 to <18 years of age: IV ceftolozane 2 g with tazobactam 1 g infused over a 60-minute period.
~Participants <12 years of age: IV ceftolozane 40 mg/kg with tazobactam 20 mg/kg infused over a 60-minute period (not to exceed a dose of ceftolozane 2g and tazobactam 1 g)."
15827570|NCT04223739|Drug|Landiolol|"Landiolol infusion with incremental doses (range from 2,5µg/kg/min to 80 µg/kg/min) with go of heart rate < 90 bpm. Doses are modified every 10 minutes if necessary.
~Once heart rate goal is obtained, switch to an oral dose of Bisoprolol."
15827571|NCT04223739|Drug|Amiodarone|Amiodarone loading dose of 5-7 mg/kg in 1 hour followed by an infusion of 1 g/day until conversion to sinus rhythm. Once sinus rhythm is obtained, switch to an oral dose of 200mg/day
15827572|NCT04223713|Procedure|TriRec|Trileaflet Reconstruction of the Aortic Valve
15827574|NCT04223700|Procedure|Ultrasound imaging & fluoroscopic confirmation|The researchers use ultrasound to scan the left and right sides of the paravertebral sagittal imaging to identify trapezius, semispinalis, erector spinae muscle, transverse process and rhomboid muscle. The radiopaque marker is attached respectively to the skin of the inferior margin of the rhomboid muscle on the left and right thoracic spinal spines. Then, as the first step for the scheduled nerve block to the patient, thoracic vertebra level verification using C-arm is performed. At this time, left and right level of the transverse process of thoracic spine marked with the radiopaque marker are confirmed and recorded.
15827575|NCT04223687|Other|Sugar-Sweetened Beverage Warning Label|Labels with a pictorial warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research.
15827576|NCT04223687|Other|Neutral label|Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.
15827577|NCT04223674|Diagnostic Test|Serological screen and treat|Multi-antigen sero-diagnostic test for measurement of P. vivax antibodies in plasma from finger stick as a means to detect hypnozoite carriers for treatment
15827578|NCT04223661|Drug|Lenalidomide Pill|Lenalidomide will be administered PO on Days 1 through 21 of each 28 day cycle at the dose according to the frailty score and creatinine clearance.
15827579|NCT04223661|Drug|Dexamethasone|Dexamethasone will be administered at 20 mg per week. During weeks when the subject receives an infusion of daratumumab, dexamethasone will be administered on infusion days at a dose of 20 mg IV before the infusion.
15827580|NCT04223661|Drug|Daratumumab|Daratumumab (1800 mg) will be administered by SC injection by manual push over approximately 3 - 5 minutes in the abdominal subcutaneous tissues in the left/right locations, alternating between individual doses. The volume of the SC solution will be 15 mL for the 1800 mg dose
15827581|NCT04223648|Drug|tremelimumab/durvalumab, ipilimumab/nivolumab and nivolumab monotherapy|"Subjects will receive 1 cycle of tremelimumab/durvalumab
~Subjects will undergo resection to obtain tumor for generation of autologous tumor infiltrating lymphocytes (TIL) cultures and blood draw to obtain peripheral blood mononuclear cell (PBMC)s
~TIL and PBMC will undergo immunoselection based on binding to an anti-programmed cell death 1 (PD-1) antibody and then will be expanded ex vivo.
~Subjects will receive 3 cycles of ipilimumab/nivolumab
~• Subjects will undergo staging with computer tomography (CT) chest/abdomen/pelvis and brain magnetic resonance imaging (MRI) or CT scan.
~subjects with stable disease will continue with nivolumab monotherapy; Subjects with progressive disease will proceed to cell therapy."
15827582|NCT04223635|Drug|Pexidartinib|Single, 200-mg capsule will be administered orally on Day 1 with 240 mL of water, following an overnight fast of at least 10 hours.
15827583|NCT04223622|Biological|ASC secretome|The osteochondral explants isolated from arthroplasty patients will be induced to an OA phenotype and treated with ASC secretome (either complete conditioned medium or extracellular vesicles) in order to investigate its therapeutic potential.
15827584|NCT04223596|Drug|Brigatinib|Brigatinib 90 mg for the first 7 days (D1-7 at cycle 1) and then 180 mg daily thereafter for QW4 cycles of duration (28 days+-3 days)
15827585|NCT04223583|Drug|Anlotinib Hydrochloride|The standard first-line chemotherapy regimen (adriamycin + ifosfamide) failed
15827591|NCT04223544|Diagnostic Test|Influenza POC and laboratory testing|Participation in the study is voluntary and carried out after the consent of the examined person. The examination consists of: 1) completing the questionnaire and 2) taking the throat swab twice by the researcher. Two throat swab samples will be taken at the same time. Both samples will be used for virological examination to determine the presence of influenza virus material using non-invasive tests: one sample will be analyzed by a quick 'on-site' test - Flu SensDx kit, while the other sample will be transported to the laboratory, where the reverse transcriptase polymerase chain reaction (RT-PCR) - reference method - will be performed to confirm the presence of influenza genetic material. Swabs are planned to be collected during the 2019/2020 influenza epidemic season (January-March).
15827592|NCT04223531|Drug|Normal Saline 0.9% Infusion Solution Bag|Participants will receive a normal saline infusion at a rate of 10ml per unit of body surface area per minute for 120 minutes.
15827593|NCT04223518|Dietary Supplement|Serum bovine immunoglobulin|Serum bovine immunoglobulin (SBI), also known by the brand name of Enteragam (Proliant Biologicals, Ankeny, Iowa) is derived from bovine serum and classified as a medical food composed of >90% protein which consists primarily of immunoglobulins (>50% of IgG) along with other bovine proteins and peptides similar to those commonly consumed by humans in beef products.
15827594|NCT04223518|Dietary Supplement|Placebo|Hydrolyzed Collagen
15827619|NCT04223310|Drug|Virtual AAD TEST group|"Perform virtual AAD test using a voltage map acquired during de novo AF ablation procedure
~Preselect drug with optimal antiarrhythmic effects in the patient.
~Take an AAD selected by virtual AAD simulation in patients who recur AF after catheter resection
~Drug selection should be decided according to the guidelines.
~A follow-up of rhythm follow-up has to be conducted according to the above study design."
15827595|NCT04223505|Diagnostic Test|Contrast enhanced ECG-gated cardiac CT (CCT)|Contrast enhanced ECG-gated cardiac CT (CCT) is a sensitive, noninvasive alternative method used to exclude of left atrial and LAA thrombus. CCT provides high spatial and good temporal resolution and its ability to detect thrombus has been evaluated. CCT, compared to TEE, for the exclusion of thrombus in the LAA had a sensitivity and specificity of 100% and 99.3%, respectively. A high sensitivity is needed to minimize risk of embolus, and if a thrombus is detected on CT, a confirmatory TEE may be performed or patients may receive anticoagulation. Some argue that the potential benefits of CT and its lower associated procedural risk, the risk:benefit ratio would still favour CT.
15827596|NCT04223505|Diagnostic Test|Transesophageal Echocardiography (TEE)|TEE is considered the reference standard to rule-out left atrial (LA) and left atrial appendage (LAA) thrombus prior to cardioversion. Several studies have examined the accuracy of TEE for detecting LAA thrombus. Compared to autopsy and intraoperative findings, TEE has a mean sensitivity of 100% and mean specificity of 99%. Although the gold standard, a TEE-guided therapy is still associated with an embolic rate of 0.8%.
15827597|NCT04223492|Diagnostic Test|Liquid biopsy|A blood sample containing circulating tumor DNA and circulating tumor cells.
15827598|NCT04223492|Diagnostic Test|Multi-parametric MRI|Multi-parametric MRI combines different imaging protocols in one session to measure more functional items than perfusion alone, addressing different aspects of tumor biology.
15827599|NCT04223479|Drug|Probiotic Formula Capsule|The Probiotic will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 6 weeks.
15827600|NCT04223479|Drug|Placebos|The Placebos will be coded in a specific label by a researcher who will not be in contact with the participants and administrated randomly based on gender in a double-blind manner. The patient will receive 2 bottles of the placebo every 2 weeks and will be followed weekly for 6 weeks.
15827601|NCT04223466|Procedure|Subxiphoid surgery procedure|Subxiphoid procedure for thymectomy
15827602|NCT04223466|Procedure|VATS surgery procedure|VATS procedure for thymectomy
15827603|NCT04223453|Diagnostic Test|BIA and DXA|Patients with acute pneumonia measured simultaneously with DXA-scan and BIA-impedance
15827604|NCT04223440|Other|MRI|MRI on both shoulder
15827605|NCT04223440|Other|ultrasonographic explorations|ultrasound and elastography explorations on both shoulder
15827606|NCT04223427|Procedure|Directional and single ring STN-DBS on gait|"Surgery for STN-DBS and STN-LFP recordings during gait initiation (M1): 15 days
~Surgery for STN-DBS electrodes implantation
~Placement of stimulation electrodes according to the usual procedure, including a MRI with contrast product
~Intraoperative electrophysiological recordings
~Intraoperative clinical evaluation
~Intraoperative identification of the electrodes and final position with X-Ray
~Post-operative 3D helical TDM without iode injection
~STN-LFP recordings during gait initiation performed 3 to 5 days after surgery
~Placement of the neurostimulator (5 days after surgery)
~Acute testing of STN-DBS for first parameters setting programming
~Follow-up of the patient with outpatient visits as usually performed in PD patients operated for STN-DBS with progressive adaptation of parameters settings using single-ring stimulation.
~Directional and single ring STN-DBS on gait (M7)"
15827607|NCT04223414|Device|Analgesia Nociception Index (ANI)|"ANI will be used to analyse the autonomic nervous system's response to volume expansion.
~ANI will be assessed during surgery, before during and after the volume expansion"
15827608|NCT04223401|Other|Prehabilitation|"Patients will undergo 6 Minutes Walking Test (6-MWT), spiroergometry (VO2 max; AT), a grip strength test, a timed Up & Go (TUG) test, 10 m sprint test and sit to stand test before and after prehabilitation. The trimodal intervention will involve:
~Nutritional intervention
~Psychological intervention
~Exercise intervention"
15827609|NCT04223388|Dietary Supplement|Lactobacillus plantarum 276|5 Billion CFU/dose, serving size = 1 capsule/day
15827610|NCT04223388|Other|Placebo|Placebo product, serving size = 1 capsule/day
15827611|NCT04223375|Behavioral|Nutrition Training|Postpartum women were educated on postpartum healthy and regular nutrition.
15827612|NCT04223362|Other|Community-based physical activity programme|After completing a pulmonary rehabilitation programme, participants will enrol a 6-months personalised community-based physical activity programme, which will include 2 sessions/week, with the aerobic training being the cornerstone. Patients will receive the PICk UP manual and a diary to register their physical activities. During the 1st month the physiotherapist will guide patients through 4 types of outdoors and indoors physical activities. Patients will then be asked to choose and commit to 1 or 2 activities, according to their preferences, which they shall integrate for another 5 months. During this period, the support provided by physiotherapist will decrease over time.
15827613|NCT04223362|Other|Pulmonary Rehabilitation|Patients will receive the same pulmonary rehabilitation programme as the experimental group, i.e., exercise training twice a week and education and psychosocial support once every other week, which integrates physical activity recommendations.
15827614|NCT04223349|Drug|JNJ-70033093|JNJ-70033093 capsules will be administered orally .
15827615|NCT04223349|Drug|Placebo|Matching placebo in capsule will be administered orally.
15827616|NCT04223336|Behavioral|Brief physical activity and diet intervention|The intervention is an integrated care pathway that provides a computerized prompts for practitioners in the STOP program via their online portal. For a participant who is in the intervention group, the online portal will screen the participant for their physical activity and fruit/vegetable consumption and provide the practitioner (who is seeing this participant for their visit) with computerized alerts for physical activity and fruits/vegetable consumption. Specifically, the portal will prompt practitioners to provide a brief intervention for these two behaviours using risk communication and will also suggest brief intervention language designed based on the Elicit-Provide-Elicit framework. The portal will also have available a self-monitoring resource for physical activity and fruits/vegetable consumption and will prompt practitioners to provide this self-monitoring resource to the participant during their visit.
15827617|NCT04223323|Dietary Supplement|Almonds|Participants in the intervention group will consume 2oz of almonds daily over the course of 12 weeks.
15827618|NCT04223323|Dietary Supplement|Pretzels|Participants in the control group will consume an isocaloric amount of pretzels daily over the course of 12 weeks.
15827735|NCT04222374|Procedure|Intervention at the Methodology and Data Management Centre of Bordeaux University Hospital|Transfer of the data associated with the samples to the NCI.
15827620|NCT04223310|Drug|Empirical AAD group|"Perform virtual AAD test using a voltage map acquired during de novo AF ablation procedure
~Selection of AAD based on the experience of the attending physician, independent of the results of the virtual AAD test in patients who recur AF after catheter resection
~Drug selection should be decided according to the guidelines.
~A follow-up of rhythm follow-up has to be conducted according to the above study design."
15827621|NCT04223297|Procedure|lung ultrasound|"The lung ultrasound will be performed by following the  Blue protocol "
15827622|NCT04223284|Other|D-Limonene|Patient will put the aspUraclip®, a commercially available mini-inhalator filled for our study purpose filled with 1% D-Limonene in the nose for 15 minutes
15827623|NCT04223284|Other|SLVO|Patient will put the aspUraclip®, a commercially available mini-inhalator filled for our study purpose filled with 1% SLVO in the nose for 15 minutes
15827624|NCT04223271|Diagnostic Test|Indicor|Handheld device with attached PPG sensor that is paired with a tablet to estimate left ventricular end diastolic pressure. Subjects will blow into the device in order to perform a standardized Valsalva maneuver for 10 seconds. The index finger will be resting in the PPG sensor during the test. Each test requires three efforts, with 45 seconds rest between efforts.
15827625|NCT04223258|Device|Automatic Oxygen control|The CLiO device is integral to the Avea infant ventilator and allows automated OXYGEN adjustment aiming to maintain SpO2 within assigned target range using neonatal pulse oximeter. When first started it adopts the FiO2 previously set by the clinician as the initial 'Baseline FiO2' level. Thereafter, the changes to the FiO2 and their frequency depend on whether SpO2 is below, above or within the target range, the trend in SpO2 and all changes are proportionate to the 'Baseline FiO2' level.
15827626|NCT04223258|Other|Manual Oxygen Control|In the manual arm the oxygen is adjusted manually by the clinical team.
15827627|NCT04223245|Behavioral|exercise+multi-modal sensory feedback (MMSF)|home program of 3 stepping exercises and 3 balance exercises with progression of speed, step distance and reduced vision. Real-time sensory feedback during ex. using ankle, wrist wts., laser on chest and mat with footpads and clickers (auditory feedback during stepping)
15827628|NCT04223245|Behavioral|Exercise only|3 stepping and 3 balance exercises which are to progress in speed and distance of movement as well as progress to eyes closed while performing.
15827629|NCT04223232|Drug|[14C]-MD1003|single oral dose of 100mg [14C]-MD1003
15827630|NCT04223219|Drug|Fentanyl|"Induction of anesthesia : Midazolam 2 mg, Fentanyl 3 µg/kg, propofol 50-100 mg and Atracurium 0.5 mg/kg.
~Maintenance of anesthesia (intraoperative until tracheal extubation):
~Maintenance will be achieved by isoflurane with concentration 0.5-1.5 % with 40% oxygen. During cardiopulmonary bypass by continuous infusion of Propofol at a rate of 2 mg/kg/hr. and Atracurium at a rate of 10 g/kg/min.
~The patients will receive fentanyl infusion at a rate of 1 µg/kg/h and fentanyl bolus 20-40 µg according to patient hemodynamics. (tachycardia: increase of heart rate >20% of baseline or hypertension: increase of blood pressure >20% of baseline).
~After tracheal extubation:
~all the patients will receive standard analgesia (i.v. paracetamol 1 gm every 12 hours and i.v. ketorolac 30 mg every 12 hours) and morphine patient controlled analgesia with bolus dose = 2 mg, lockout interval = 10 minutes, 4-hour dose limit = 10 mg, with no background infusion."
15827631|NCT04223219|Drug|Fentanyl, Propofol|"Induction of anesthesia : Midazolam 2 mg, Fentanyl 3 µg/kg, propofol 50-100 mg and Atracurium 0.5 mg/kg.
~Maintenance of anesthesia (intraoperative until tracheal extubation):
~Maintenance of anesthesia will be achieved by isoflurane with concentration 0.5-1.5 % with 40% oxugen. During cardiopulmonary bypass by continuous infusion of Propofol at a rate of 2 mg/kg/hr. and Atracurium at a rate of 10 g/kg/min.
~The patients will receive fentanyl bolus 20 µg/hr and propofol 20 mg at the time of surgical stimulation and according to patient hemodynamics (repeated as required).
~After tracheal extubation:
~all the patients will receive standard analgesia (i.v. paracetamol 1 gm every 12 hours and i.v. ketorolac 30 mg every 12 hours) and morphine patient controlled analgesia with bolus dose = 2 mg, lockout interval = 10 minutes, 4-hour dose limit = 10 mg, with no background infusion."
15827632|NCT04223219|Drug|Dexmedetomidine, Ketamine, Magnesium sulfate|"Induction of anesthesia : Midazolam 2 mg, Fentanyl 3 µg/kg, propofol 50-100 mg and Atracurium 0.5 mg/kg.
~Maintenance of anesthesia (intraoperative until tracheal extubation):
~Maintenance of anesthesia will be achieved by isoflurane with concentration 0.5-1.5 % with 40% oxygen. During cardiopulmonary bypass by continuous infusion of Propofol at a rate of 2 mg/kg/hr. and Atracurium at a rate of 10 g/kg/min.
~The patients will receive infusions of dexmedetomidine 0.2 µg/kg/h, ketamine 2 µg/kg/min, and magnesium sulfate 5 mg/kg/h.
~After tracheal extubation:
~all the patients will receive standard analgesia (i.v. paracetamol 1 gm every 12 hours and i.v. ketorolac 30 mg every 12 hours) and morphine patient controlled analgesia with bolus dose = 2 mg, lockout interval = 10 minutes, 4-hour dose limit = 10 mg, with no background infusion."
15827633|NCT04223206|Dietary Supplement|NATURLENS|Oral administration of dietary supplement (26 g/day) to dissolve in 100 or 150 mL of water
15827634|NCT04223193|Drug|Tavapadon|Participants will be randomized to receive tavapadon 5 mg QD to 15 mg QD tablet once daily orally for 27 weeks.
15827635|NCT04223193|Drug|Placebo|Participants will receive placebo matching to tavapadon QD orally for 27 weeks.
15827636|NCT04223180|Device|Robotic assisted intervention|Robotic treatment of the upper limb (30 sessions, 5 times a week) using a set of 4 robotic devices: Motore (Humanware); Amadeo, Diego, Pablo (Tyromotion). The training will include motor-cognitive exercises specifically selected to train spatial attention, vision and working memory, praxis, executive function, and speed of processing.
15827637|NCT04223167|Dietary Supplement|Red Bull Energy Drink|473 ml Reb Bull Energy Drink
15827638|NCT04223167|Dietary Supplement|Water|473 ml Water
15827639|NCT04223154|Device|Real iTBS to the dlPFC|This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key).
15827640|NCT04223154|Device|Sham iTBS to the dlPFC|This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key).
15827641|NCT04223141|Procedure|SIA|As indicated by arm description
15827712|NCT04222595|Other|Fluenz Tetra nasal spray suspension|Prophylaxis of influenza in children and adolescents from 24 months to less than 18 years of age. Single dose vaccine, administered as a nasal spray (0.2 ml administered as 0.1 ml per nostril).
15827713|NCT04222582|Device|Transcranial direct current stimulation (tDCS)|Transcranial direct current stimulation (tDCS) is a non-invasive form of brain stimulation which uses a weak current (2mA direct current) to temporarily excite or inhibit underlying brain regions with small electrodes placed on the scalp.
15827642|NCT04223128|Procedure|Ultrasound guided transversus abdominis plane block|Using an 18 G Tuohy needle (80 mm Smiths medical Portex®) and the layers of the abdominal wall will be identified guided by superficial high-frequency 45 mm linear array ultrasound probe (13 MHz) as described by McDonnell and colleagues.(1) Twenty millilitre of 0.25% bupivacaine will be injected slowly after careful aspiration to ensure no vascular injury has occurred. Successful injection will produce an echo-lucent space between the muscle layers (internal oblique and transversus abdominis). All TAP blocks will be performed by the same anesthetist.
15827643|NCT04223115|Behavioral|Digitalized CBT with phone coaching|Digitally delivered CBT intervention with weekly phone coaching
15827644|NCT04223115|Other|Psychoeducation about depression|Psychoeducational material about depression in a digitalized form
15827645|NCT04223102|Procedure|Tissue collection|A flexible sigmoidoscopy is a procedure in which a flexible tubularized camera approximately 1 cm in diameter is inserted into the anus and advanced proximally to the sigmoid colon (approximately 20 cm). At that time a rectal biopsy of the tumor will be obtained as well as a sample from >5cm proximal to the tumor, with a separate biopsy forcep. Tattoo injection, as standard of care, will be performed within 1 cm distal to the tumor to identify the location in the future or for surgical intervention. If there is inability to get proximal to the tumor then a location at least 5 cm adjacent in any direction will be sufficient so long as it is grossly normal appearing.
15827646|NCT04223089|Diagnostic Test|Near Infrared Spectroscopy|"The Kent Camera is intended for use by healthcare professionals as a non-invasive tissue oxygenation measurement system that reports an approximate value of the following in superficial tissue:
~oxygen saturation (StO2),
~relative oxyhemoglobin level (HbO2), and
~relative deoxyhemoglobin (Hb) level
~The Kent Camera displays two-dimensional color-coded images of tissue oxygenation of the scanned surface and reports multispectral tissue oxygenation measurements for selected tissue regions. The Kent Camera is indicated for use to determine oxygenation levels in superficial tissues."
15827647|NCT04223076|Drug|Chlorhexidine 0.2%, Corsodyl|Comparison of Corsodyl and Curasept
15827648|NCT04223076|Drug|Chlorhexidine 0.2%, Curasept|Chlorhexidine 0.2% mouthwash with an Anti Discoloring System (ADS)
15827649|NCT04223063|Behavioral|Exercise program|As per the intervention arm
15827650|NCT04223050|Drug|Oxygen gas|Administering oxygen to achieve the desired peripheral oxygen saturation
15827651|NCT04223037|Biological|Japanese Encephalitis Vaccine produced by IMBCAMS|Dosage form: 0.5mL/vial
15827652|NCT04223037|Biological|Japanese Encephalitis Vaccine produced by Liaoning Chenda|Dosage form: 0.5mL/vial
15827653|NCT04223024|Drug|CCRT+Nimotuzumab|concurrent cisplatin (100mg/m2, every three weeks,D1,D22,D43 of intensity modulated radiotherapy) + Nimotuzumab (200mg, once a week during radiotherapy, a total of 7 weeks)
15827654|NCT04223024|Drug|CCRT alone|concurrent cisplatin (100mg/m2, every three weeks,D1,D22,D43 of intensity modulated radiotherapy )
15827655|NCT04223011|Behavioral|In-Hospital Recovery Coach Intervention|The recovery coach will meet with the patient at least once during the hospital admission, during which he/she will reinforce the importance of continuing medication treatments, if initiated, as well as community and social supports for recovery and will discuss the plan for engaging in these services. This will include recommendations for suitable community resources for recovery services, or for housing, transportation, or other external barriers that may make it more difficult to engage in outpatient treatment. The recovery coach will encourage the participant to complete a relapse prevention plan, and help the patient organize post-discharge appointments and review medications. If applicable, family members and significant others will be encouraged to be present for these encounters.
15827656|NCT04222998|Other|Home-based growth charts|The growth chart contains simple information of nutritious food, health, and sanitation information at the top and height chart is located at the bottom where caregivers can measure their child's linear growth. Growth charts will be installed in intervention group homes just after the baseline survey.
15827657|NCT04222998|Other|Home visits for baseline surveys|Households will be visited for baseline surveys.
15827658|NCT04222998|Other|Home visits for end line surveys|Households will be revisited after 1 year of grace-period for baseline end line surveys.
15827659|NCT04222998|Other|Measurement of child's height-for-age and weight-for-age|The child's height-for-age and weight-for-age will be measured for participating dyads at the time of the baseline and end line surveys.
15827660|NCT04222985|Biological|HSV 2 Formulation 1|Route of administration: Intramuscular
15827661|NCT04222985|Biological|HSV 2 Formulation 2|Route of administration: Intramuscular
15827662|NCT04222985|Biological|HSV 2 Formulation 3|Route of administration: Intramuscular
15827663|NCT04222985|Biological|HSV 2 Formulation 4|Route of administration: Intramuscular
15827664|NCT04222985|Biological|HSV 2 Formulation 5|Route of administration: Intramuscular
15827665|NCT04222985|Biological|HSV 2 Formulation 6|Route of administration: Intramuscular
15827666|NCT04222985|Biological|Sodium Chloride 0.9%|Route of administration: Intramuscular
15827667|NCT04222972|Drug|Pralsetinib|Administered orally
15827668|NCT04222972|Drug|Carboplatin|Administered IV
15827669|NCT04222972|Drug|Cisplatin|Administered IV
15827670|NCT04222972|Drug|Pemetrexed|Administered IV
15827671|NCT04222972|Drug|Pembrolizumab|Administered IV
15827672|NCT04222972|Drug|Gemcitabine|Administered IV
15827673|NCT04222972|Drug|Paclitaxel|Administered IV
15827674|NCT04222972|Drug|Nab-Paclitaxel|Administered IV
15827675|NCT04222959|Behavioral|Girls Invest Mobile App Intervention|"Gender and life skills training:
~App-based trainings culturally tailored and adapted to this population using our formative work and based on elements from life skills trainings used in previous effective pregnancy prevention interventions among youth. We added sessions focused specifically on financial skill-building. Trainings included app features such as gaming dynamics, and quizzes. Each module estimates 25 minutes to complete.
~Training modules:
~The first 3 modules cover gender and cultural norms related to girls' social and economic opportunities, increasing girls' recognition of the importance of financial literacy, independence, and power in decision-making. The last 3 modules cover finance, educational loans, and employment."
15827714|NCT04222569|Procedure|T-piece|Spontaneous breath trial with a T-piece
15827715|NCT04222569|Procedure|PSV 7 and PEEP 0|Spontaneous breath trial with a pressure support ventilation of 7 cmH2O and no positive end expiratory pressure
15827676|NCT04222959|Other|Savings Account Subsidies|Girls Invest builds upon two broadly accepted economic empowerment strategies: a) savings and b) cash transfers. The most promising economic empowerment interventions for girls have incorporated concrete economic resources along with training on life skills and gender.1-3 Trainings encourage girls to save additional funds (e.g. from family). Participants have online access and can withdraw savings anytime, however, we will assess savings behaviors to consider other account features (e.g. commitment-based savings). In the future, subsidies could be supported via ads in the app and financial support from banks.
15827677|NCT04222946|Other|Dry needling|Bilateral dry needling in latent trigger points of the Flexor digitorum Brevis Muscle
15827678|NCT04222933|Device|Motorized cryotherapy|application of motorized cryotherapy after ACL reconstruction
15827679|NCT04222933|Device|Classical cryotherapy|application of an ice bag
15827680|NCT04222920|Other|Dose reduction to 2mg/L|Adalimumab dose reduction aiming drug concentration of 2mg/L
15827681|NCT04222920|Other|Dose reduction to 5mg/L|Adalimumab dose reduction aiming drug concentration of 5mg/L
15827682|NCT04222920|Drug|Adalimumab|Adalimumab
15827683|NCT04222894|Other|Plant-based diet|Weekly instructions will be given to the participants in the intervention group about following vegan diet.
15827684|NCT04222894|Other|Control Diet|Participants will be asked to continue their usual diets for the 12-week study period.
15827685|NCT04222881|Procedure|AVF anastomosis|Type of arteriovenous anastomosis
15827686|NCT04222855|Drug|Diltiazem|Puerperal patients was administered (60 mg) orally every 8 hours with diltiazem (tables).
15827687|NCT04222842|Drug|CM082|Subjects will receive CM082 orally for two weeks followed by two weeks off in four-week cycles.The total treatment period is tentatively set at 3 cycles (12 weeks).
15827688|NCT04222829|Procedure|Megadose Shinbaro Pharmacopuncture|"Pharmacopuncture is a treatment that combines 2 of the most frequented Korean medicine treatment methods - traditional acupuncture and herbal medicine - by injecting herbal medicine extract at acupoints.
~Shinbaro is a refined herbal formulation used to treat inflamed lesions and bone diseases."
15827689|NCT04222816|Drug|Lithium Carbonate|Lithium carbonate 800-900 mg orally daily for 12 weeks
15827690|NCT04222816|Drug|Sodium chloride|Sodium chloride 1gm daily per orally for 12 weeks
15827691|NCT04222790|Drug|monosialic gangliosides|The experimental group received 80 mg of monosialic gangliosides (GM1) on days -1, 1, and 2 of albumin paclitaxel (GM1 is a single infusion).
15827692|NCT04222790|Other|Placebo|The control group received placebo on days -1, 1, and 2 of albumin paclitaxel (placebo as a single infusion)
15827693|NCT04222777|Diagnostic Test|Cinematographic Recording|A cinematographic recording during the second half of extension of the cervical spine will be made during 16 seconds at two timepoints with an interval of two weeks.
15827694|NCT04222764|Diagnostic Test|Real-time three-dimensional echocardiography|"The initial hemodynamic assessment and monitoring using echocardiography will be performed within 12h following ICU admission. TTE will be performed systematically as first-line examination and TEE will be performed only on ventilated and sedated patients for whom additional information is required for their management, according to the standards of care of the participating centers. In that case, TEE will be performed immediately after TTE.
~3D echocardiographic measurements will be performed after the examination by two independent intensivists expert in critical care echocardiography who will be blinded from the usual parameters of RV systolic functions; these parameters will be measured during the examination to guide the management of patients, according to the standard of care of the participating centers."
15827695|NCT04222751|Device|Ankle Splint|Ankle splint will be slightly modified from the commercial form to include a pneumatic air cell secured under the forefoot below the splint's padded lining. This replaces the foam wedge provided by the manufacturer, allowing a gradual adjustment of the forefoot/toe region.
15827696|NCT04222738|Dietary Supplement|GINOFF1|The intervention lasted for six weeks and consisted of the administration of powdered ginger extracts in the form of capsules at a dose of 2g/day.
15827697|NCT04222725|Drug|TRS01 eye drops|Dosed 4 times a day (QID)
15827698|NCT04222725|Drug|TRS01 eye drops|Dosed QID
15827699|NCT04222725|Drug|TRS01 eye drops|Dosed QID
15827700|NCT04222725|Drug|Placebo eye drops|Dosed QID
15827701|NCT04222712|Drug|TRS01 eye drops|Dosed four times a day (QID)
15827702|NCT04222712|Drug|TRS01 eye drops|Dosed four times a day (QID)
15827703|NCT04222699|Drug|Mupirocin calcium ointment, 2%|Mupirocin nasal ointment is used to treat or prevent infections in the nose due to certain strains of Staphylococcus aureus bacteria. This medicine works by killing bacteria or preventing their growth.
15827704|NCT04222699|Drug|Topical Chlorhexidine, 4%|"Chlorhexidine is an antiseptic that fights bacteria.
~Topical chlorhexidine is used to clean the skin to prevent infection that may be caused by surgery, injection, or skin injury."
15827705|NCT04222686|Drug|Perindopril Arginine|10 mg Perindopril tablet / day will be added to the usual treatment for each patient for a period of 8 weeks.
15827706|NCT04222686|Drug|Losartan Potassium|100 mg Losartan tablet will be added to the usual treatment for each patient for a period of 08 weeks.
15827707|NCT04222673|Behavioral|Peer Specialist Suicide Prevention|The intervention will last 3-months, a time frame that overlaps with the typical duration of a VA suicide high risk flag. Meetings will be 30-45 minutes and occur primarily in the community, home, or by telephone. Session content will be rooted in Peer Specialists (PSs) offering nonjudgmental empathic support, active listening, and constructive disclosure and role modeling. A primary focus will be helping patients with flags to identify and strengthen connections with informal supports and participation in activities in their community that will enable them to feel more worthwhile as individuals and hopeful about their future.
15827708|NCT04222660|Dietary Supplement|Blackmores Omega Daily (4 1g capsules per day)|Subjects enrolled in phase two of the study will be instructed to take 4 capsules per day (2 in the morning and 2 in the evening). Each capsule contains 1000 mg of triglyceride; 35% eicosapentaenoic acid and 25% docosahexaenoic acid.
15827709|NCT04222647|Drug|WO533|Intravaginal application
15827710|NCT04222634|Other|Radiotherapy (SBRT) and/or surgery (metastasectomy)|Metastasis-directed therapy (surgery and/or radiotherapy) as treatment for oligoprogressive lesions
15827711|NCT04222621|Other|Pregnant women without intervention|Pregnant women with those exposures of interest determined in specific research based on the registry
15827716|NCT04222569|Procedure|PSV 0 and PEEP 0|Spontaneous breath trial without pressure support ventilation and positive end expiratory pressure, with a patient intubated and connected to the ventilator
15827717|NCT04222556|Behavioral|Thiwáhe Gluwáš'akapi|Thiwáhe Gluwáš'akapi (TG, sacred home in which family is made strong) is a cultural adaptation of the Strengthening Families Program for Parents and Youth 10-14 (SFP 10-14). TG, like SFP 10-14, is a 7-week family-based prevention program with separate youth and adult sessions followed by family sessions. Videos teach content and spark discussion; games and activities foster interaction and provide opportunities to practice skills. Four key adaptations were made to create TG: (1) cultural kinship teachings and tribal language kinship words were embedded throughout; (2) a parent session on coping with stress was enhanced to teach recognizing and responding to trauma reactions in youth; (3) a session on listening was moved earlier in the curriculum, given cultural oral tradition; (4) session videos were remade with local actors and adapted scenarios. A multiphase optimization strategy design was used to test potential adaptations, resulting in the optimized TG program.
15827718|NCT04222556|Behavioral|Woyute Waśte|Woyute Waśte (WW) was adapted from the Colorado School of Public Health's Integrated Nutrition Education Program (INEP) for the culture and context of the reservation. Families will meet for 1 session to participate in hands-on activities - preparing healthy meals, family physical activity, and sugary drinks. They will discuss setting healthy goals and tracking progress, receive recipes and water bottles, and for 6 weeks after the session, will get text messages with additional program content.
15827719|NCT04222543|Combination Product|RGD PET/CT|Patients will receive an RGD PET/CT and a CT perfusion scan prior to treatment and during chemoradiotherapy
15827720|NCT04222530|Diagnostic Test|Linear EUS first|Linear endoscopic ultrasonography followed by magnifying narrow band endoscopy are used to determine the depth of invasion of early rectal cancer.
15827721|NCT04222530|Diagnostic Test|ME-NBI first|Magnifying narrow band endoscopy followed by linear endoscopic ultrasonography are used to determine the depth of invasion of early rectal cancer.
15827722|NCT04222517|Procedure|Incisional hernia repair by the mesh implant in sublay retromusuclar position|"Incisional hernia repair using mesh prolene implant in sublay retromuscular position. Dissect the posterior rectus sheets, suture them continuously, formed a retromuscular space in which the standard prolene mesh implant is installed. Perform hemostasis. Install the drainage tube into the retromuscular space.
~After that, the anterior rectus sheets were sutured, hemostasis was performed, a drainage tube was installed in the subcutaneous tissue. Drainage tubes were connected to the UnoVac vacuum aspiration system (Unomedical, Denmark)."
15827723|NCT04222517|Procedure|Incisional hernia repair by the mesh implant in sublay retromusuclar position with using a local hemostatic Hemoblock|"Incisional hernia repair using mesh prolene implant in sublay retromuscular position. Dissect the posterior rectus sheets, suture them continuously, formed a retromuscular space in which the standard prolene mesh implant is installed. Perform hemostasis. Install the drainage tube into the retromuscular space. Used a local hemostatic Hemoblock 15 ml in this space.
~After that, the anterior rectus sheets were sutured, hemostasis was performed, a drainage tube was installed in the subcutaneous tissue. Used a local hemostatic Hemoblock 15 ml in subcutaneus space. Drainage tubes were connected to the UnoVac vacuum aspiration system (Unomedical, Denmark)."
15827725|NCT04222491|Drug|Peanut oral immunotherapy|Peanut oral immunotherapy for peanut allergy
15827726|NCT04222478|Other|Specific auriculotherapy|"3 sessions of auriculotherapy with semi-permanent needles on the 6 points according to the protocol of Alimi at one month intervals."
15827727|NCT04222478|Other|Non-specific auriculotherapy|3 sessions of auriculotherapy with semi-permanent needles on non-specific points.
15827728|NCT04222439|Device|AI for the Diagnosis of Gastrointestinal Diseases|After receiving standard preparation regimen, patients go through colonoscopy or gastroscopy under the AI monitoring device. The whole procedure is monitored by AI associated recognition system. Gastrointestinal diseases will be detect and diagnosis in which the AI device will automatically captured relevant images and report the site of each segment on the screen. Histology analysis is set as a golden standard. Then all the AI captured images will be reviewed by human group, which consists of three to five experienced endoscopic physicians.
15827729|NCT04222426|Other|89Zr-atezolizumab PET scans|Patients receive a total amount of 10 mg unlabeled atezolizumab, this will be added to the tracer to prevent rapid clearance during imaging. A labeled dose of 37 Megabequerell (MBq) 89Zr-atezolizumab (±10%; 1 Millicurie) will then be administered. The tracer will be administered intravenously (i.v.). All patients will undergo two 89Zr-atezolizumab PET scans, one at baseline and one after two doses carboplatin induction treatment. After each tracer injection, 89Zr-atezolizumab PET scans will be performed on day 4 (96 ± 6h after tracer administration).
15827730|NCT04222413|Drug|Metarrestin|Phase IA: 1,2,4 or 6 mg PO on Mondays-Wednesdays-Fridays or Mondays-Fridays or Mondays only. Phase IB: PO according to the dose and schedule estimated during Phase IA
15827731|NCT04222400|Diagnostic Test|Frailty Assessment|Bioelectrical Impedance Analysis 6 Minute Walk Test Grip Strength Questionnaires Muscle Mass Evaluation via CT
15827732|NCT04222387|Device|OCT-B scan|OCT-B scan (Optical coherence tomography)
15827733|NCT04222374|Procedure|Intervention in the UroCCR sites|"Blood sampling of a 5ml tube per patient. (for eligible patients recruited in the study, after signing the consent)
~DNA extraction:
~For the patients of Bordeaux University Hospital, 2 aliquots will be constituted:
~1 aliquot for Expanded GWAS, containing at least 2 μg of DNA,
~1 aliquot for the UroCCR biobank.
~For patients from other UroCCR centers, only 1 aliquot will be constituted:
~1 aliquot for Expanded GWAS, containing at least 2 μg of DNA.
~Transmission of the extracted DNA samples to the Biological Resource Center (CRB) of Bordeaux."
15827734|NCT04222374|Procedure|Intervention in the CRB of Bordeaux University Hospital|"Temporary storage of DNA samples for Expanded GWAS before shipping to the NCI. Storage of samples for the DNA biobank.
~Overall packing of GWAS samples for shipment to the NCI.
~Shipping to the NCI: Constitutive DNA samples must be sent to the NCI by May 1, 2020 for inclusion in the Expanded GWAS study."
15827736|NCT04222374|Procedure|Subsequent intervention at the NCI (for information)|"Samples will be genotyped at the NCI Cancer Genomics Research Lab using the Illumina Global Screening Network.
~GWAS combined meta-analysis, based, among others, on the results from the UroCCR samples."
15827737|NCT04222361|Procedure|Preventive recommendations for kidney disease: guidelines for improving overall outcomes (KDIGO) for AKI|Patients assigned to the treatment group will receive the AKI preventive recommendations from the KDIGO guide: withdraw nephrotoxics, ensure volemia and renal perfusion pressure by means of advanced hemodynamic monitoring-optimization (minimum monitoring objective: Unit algorithm based on volume systolic (VS) by pulse wave analysis - Flotrac® / ClearSight® system - or transpulmonary thermodilution - VolumeView® system -), monitor plasma creatinine and urinary expenditure, avoid hyperglycemia (serum blood glucose target: 110-149 mg / dl), and consider alternatives to diagnostic-therapeutic radiocontrast procedures.
15827738|NCT04222348|Drug|Metformin|850-2550 mg every 24h.
15827739|NCT04222348|Drug|Insulin Detemir|Insulin detemir associated or not with rapid insulin analogue (aspart) according to individual glycemic controls.
15827740|NCT04222335|Other|Blood samples|"Each participant will be followed-up regularly as part of the usual practice for imaging and medical consultations. During their visits, from inclusion (T0) to the end of study participation (T progression), each patient will have a blood sampling specifically for the research to analyze tumor DNA and circulating tumor cells: T0, T1month, T3 months, Tn months, T DNA C+, T progression.
~This research does not include any other act or intervention specifically required for its purposes."
15827741|NCT04222322|Device|Epitomee Capsule|Arm treatment: Epitomee Capsule combined with moderate intensity lifestyle counseling.
15827742|NCT04222322|Other|Control-Placebo|Arm treatment: Visually matching placebo capsule combined with moderate intensity lifestyle counseling.
15827743|NCT04222309|Procedure|Laparoscopically harvested omental free flap|Laparoscopically harvested omental free flap into the resection cavity of recurrent glioblastoma multiforme (GBM) patients.
15827744|NCT04222296|Device|Fitting strategy of cohlear implant of hearing aid|To determine whether new hardware and fitting strategy provides better sound quality or ease of use than generic hardware and fitting methods
15827745|NCT04222283|Drug|BIKTARVY 50Mg-200Mg-25Mg Tablet|At BSL all the participants will be switched from a booster containing regimen (ritonavir or cobicistat) to TAF/FTC/BIC (BIKTARVY).
15827746|NCT04222270|Behavioral|Champion Caregiver peer mentoring support to caregivers on child care and medication adherence to enhance achievement of viral suppression|Caregiver to caregiver peer support intervention through group/one-on-one education and counselling
15827747|NCT04222257|Drug|Antibiotics|Patients allocated to this group will receive a short course of antibiotic therapy for 2 weeks.
15827748|NCT04222257|Drug|Antibiotics|Patients allocated to continue with standard parenteral treatment will maintain the same antibiotic treatment for 4 to 6 weeks.
15827749|NCT04222244|Other|No intervention will be administered. We are only performing tests and measures.|No intervention will be administered. We are only performing tests and measures.
15827750|NCT04222231|Other|Blood-flow restriction resistance training|Training program: After 10 minutes of warm-up the participant performs three exercises with BFRT for the lower extremities. The intensity is about 15-30% of 1-RM.
15827751|NCT04222231|Other|Classical resistance training|Training program: After warm-up the participant performs three exercises for lower body. The intensity is about 60-80% of 1-RM.
15827752|NCT04222218|Device|repetitive transcranial magnetic stimulation|Cerebellar repetitive theta Burst stimulation will be performed as detailed in the Real arm description
15827753|NCT04222205|Diagnostic Test|Spontaneous breathing trial (SBT) crossover sequence 1|SBTs with T-piece breathing for one hour during odd-numbered months and SBTs with inspiratory pressure augmentation for one hour during even-numbered months.
15827754|NCT04222205|Diagnostic Test|Spontaneous breathing trial (SBT) crossover sequence 2|SBTs with inspiratory pressure augmentation for one hour during odd-numbered months and SBTs with T-piece breathing for one hour during even-numbered months.
15827755|NCT04222192|Other|Epidural block|Epidural catheter insertions
15827756|NCT04222179|Device|ultrathın esophagogastroduodenoscope|Place the naso-enteric tube together with the ultrathin esophagogastroduodenoscope from the same nasal cavity
15827757|NCT04222166|Biological|CAM|Cryopreserved Amniotic Membrane
15827758|NCT04222140|Combination Product|ERIPTO Protocol|combination biologic treatment
15827759|NCT04222140|Biological|BMAC Only|BMAC treatment only
15827760|NCT04222127|Other|EUS guided injection of gastric varices by CYA|EUS-guided injection of CYA will be done at entrance of of the varix or the perforator veins when identifiable using a mixture (1:1) of 2-octyl-cyanoacrylate & lipidol using 19G EUS-FNA needle
15827761|NCT04222127|Other|Direct endoscopic injection of gastric varices by CYA|Direct endoscopic injection of gastric varix by CYA
15827762|NCT04222114|Drug|Catumaxomab|The starting dose of catumaxomab for intra-peritoneal infusion will be 10μg, gradually increased to 20μg, 50μg and 150μg, respectively. From the second cycle, catumaxomab will be changed to 20μg,50μg,150μg on days 1,4 and 8.
15827763|NCT04222114|Drug|The treatment of investigator choice|the localized supportive treatment which has been approved or recommended by local gastric cancer guidance to treat the peritoneal metastasis.
15827764|NCT04222101|Diagnostic Test|Oral glucose tolerance test|measure insulin, glucose and FGF21 levels in response to oral glucose challenge
15827765|NCT04222088|Drug|Arthemeter-lumefantrine|Three days according to body weight (Days 0, 1 and 2). Correct drug dosage will be determined using the dosing chart (in accordance with national treatment guidelines).
15827766|NCT04222088|Drug|Chloroquine|Chloroquine according to body weight as a total dose of 25mg base/kg over 3 days (10 mg base/kg on Day 0; 10 mg base/kg on Day 1 and 5 mg base/kg on Day 2). Primaquine will be withheld for 28 days. It will be given after Day 28 follow-up, at 0.25 mg base/kg per day for 14 days.
15827767|NCT04222062|Drug|Carmustine 7.7Mg Wafer|GLIADEL wafers will be placed to cover tumor bed immediately after tumor removal.
15827768|NCT04222049|Device|Vibro Tactile Gadget|The concept is to apply vibro tactile gadget to different nerve points which when applied transmit waves to the focused parts of brain which will result in blood flow and activation of dead cells. As a result some disabled part of the body because of those dead cells can show improvement.
15827840|NCT04221503|Procedure|Planned surgical resection|Surgery of supratentorial glioblastoma (GBM).
15827769|NCT04222036|Other|Translating the Questionnaire into Turkish and Related Processes|The first step is the translation from the original language to the other language. The ideal target in the translation phase is to use people who are familiar with the structure of the original language and who are familiar with the language. Two forward translation and one reverse translation methods will be applied after obtaining the written permission of the authors. After the completion of this phase, the terminological differences arising from the translators in the translation process from the original language to Turkish will be collected and discussed on the questions. The cultural adaptation study will be terminated by determining the equivalence between the Turkish version of the index and the English original. The final version of the questionnaire and the necessary changes will be arranged specific to the investigator's society and the authors of the original questionnaire will be consulted and the questionnaire will be finalized.
15827770|NCT04222036|Other|Validity|The scale will be applied by face-to-face technique and convergent (moderate-high correlation with optimism measure) and distant (low correlation with depression and anxiety measures) validity will be evaluated.
15827771|NCT04222036|Other|Reliability|The reliability of the materials will be tested with Cronbach alpha.
15827772|NCT04222023|Drug|Intravenous immunoglobulins (IVIG)|"Experimental group: administration of a single dose of IVIG at:
~Day 10+/- 4 days
~Day 41 +/- 7 days
~Day 62 +/- 7 days The dose of IVIG is defined according the donor BKV genotype: genotype I: 0.4 g/Kg/day; genotype II and IV: 1g/kg/day."
15827773|NCT04222010|Drug|loco-regional anesthesia serratus plane bloc (Ropivacaine 2 mg/mL, 40 mL) and paravertebral placebo bloc (saline, 20 mL)|Each patient who underwent thoracoscopic surgery will be assigned to one procedure of Loco-regional anesthesia
15827774|NCT04222010|Drug|Loco-regional anesthesia : paravertebral bloc (Ropivacaine 4 mg/mL, 20 mL) and serratus plane placebo bloc (saline, 40 mL)|Each patient who underwent thoracoscopic surgery will be assigned to one procedure of Loco-regional anesthesia.
15827775|NCT04222010|Drug|Loco-regional anesthesia : serratus plane bloc (Ropivacaine 1,3 mg/mL, 40 mL) and paravertebral bloc (Ropivacaine 1,3 mg/mL, 20 mL)|Each patient who underwent thoracoscopic surgery will be assigned to one procedure of Loco-regional anesthesia.
15827776|NCT04221997|Drug|sertraline|Sertraline is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs)
15827777|NCT04221971|Drug|chemotherapy combined with NK cells infusion|chemotherapy combined with NK cells infusion
15827778|NCT04221958|Device|Electrocardiogram|"An electrocardiogram measures the electrical activity of the heartbeat. This intervention will be used on healthy adult volunteers whom are part of the staff at the institution."
15827784|NCT04221932|Device|CRRT KPI Reports|This will involve the regular report of CRRT KPI reports across the CRRT programs across the province. It will also include standardization of CRRT practices across Alberta. Reports will include those for the program (i.e., structure), device (i.e., process) and patient outcomes (i.e., outcomes).
15827785|NCT04221919|Drug|β -Blockers|Target doses of carvedilol, bisoprolol, metoprolol tartrate, or metroprolol succinate
15827786|NCT04221906|Drug|BOS-475|topical cream
15827787|NCT04221906|Drug|Active ingredient-free vehicle cream|topical cream
15827788|NCT04221906|Drug|Daivonex cream (calcipotriol 0.005%)|topical cream
15827789|NCT04221906|Drug|Betnesol-V cream (betamethasone 0.1%)|topical cream
15827790|NCT04221893|Radiation|Radiation Therapy (RT)|Undergo radiation therapy
15827791|NCT04221880|Drug|Bupivacaine Hcl 0.25% Inj|Ultrasound-guided erector spinae plane block with 20 ml %0.25 bupivacaine
15827792|NCT04221880|Drug|Saline Solution for Block|Ultrasound-guided erector spinae plane block with 20 ml saline
15827793|NCT04221880|Drug|Saline Solution intravenously|Same volume saline solution bolus and infusion as Group Lidocaine
15827794|NCT04221880|Drug|Lidocaine|1.5 mg / kg lidocaine iv. bolus and, 1.5mg / kg / h lidocaine iv. infusion
15827795|NCT04221867|Procedure|Stricture dilation with CRE balloon|Esophageal stricture is treated by dilation therapy.
15827796|NCT04221867|Procedure|Autologous fat grafting|Autologous fat graft is gathered and injected to stricture
15827797|NCT04221854|Diagnostic Test|Stool-based SDC2 DNA methylation test|Stool-based SDC2 DNA methylation test
15827798|NCT04221854|Diagnostic Test|Fecal immunochemical test|Fecal immunochemical test
15827799|NCT04221841|Other|descriptive|correlation
15827800|NCT04221828|Drug|NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension|NanoPac is manufactured using a Precipitation with Compressed Antisolvent (PCA) technique that employs supercritical carbon dioxide and acetone to generate paclitaxel nanoparticles. For clinical administration, the NanoPac powder in vial is suspended with Sterile Reconstitution Solution (1% Polysorbate 80, NF in 0.9% Sodium Chloride for Injection, USP) and then further diluted with 0.9% Sodium Chloride for Injection, USP, to achieve the final clinical formulation.
15827803|NCT04221789|Other|TB treatment assistant|Cell phone app to support self administered treatment and monitor adherence
15827804|NCT04221776|Other|Group toilet training in daycare|During the training, children wore underpants, were informed about potty training, were encouraged to drink often and were asked regularly if they felt the need to void. Tutors looked for elimination signals in the child and quickly responded by putting the child on the potty when he/she expressed the need to void or to defecate. Children were positively rewarded. Parents received a leaflet containing practical tips concerning TT and their child's successes of the past two days. They were asked to continue TT at home during the following weekend and longer if necessary. Daycare workers were asked to pay more attention on the TT during the following days and weeks to ensure the effect of the intervention.
15827841|NCT04221490|Device|Transcatheter Tricuspid Valve Replacement|Replacement of the tricuspid valve through a transcatheter approach
15828121|NCT04219449|Diagnostic Test|Protein C|measuring protein C drawn on citrated blood sample
15827805|NCT04221776|Other|Individual toilet training at home|Parents were encouraged to start TT their child, because they were considered as being ready to initiate TT. Children did not receive any intervention, but parents were asked to start TT in their own manner. Parents were allowed to search for information on methods of TT with their relatives, internet, books,...
15827806|NCT04221763|Device|His-bundle pacing.|Cardiac resynchronisation therapy can be achieved using biventricular pacing involving placement of three leads into the right atrium, right ventricle and coronary sinus (epicardial left ventricle). Alternatively the third lead may be placed at the bundle of His or left ventricular septum to pace the left bundle directly.
15827807|NCT04221750|Behavioral|Lifestyle therapy|Weight management program, in which participants are prescribed a balanced diet that provides and energy deficit of 500 to 750 kcal per day to induced ~10% weight loss plus Supervised combined aerobic and resistance exercise training three times weekly
15827808|NCT04221750|Drug|Metformin Hydrochloride|Given orally starting at 500 mg (one tablet) taken orally once a day with meals. After a week, the dose of metformin will be increased to 1000 mg (two tablets) daily. After another week, the dose of metformin will be increased to 1500 mg (three tablets) daily.
15827809|NCT04221750|Drug|Placebo|Given orally starting at 500 mg (one tablet) taken orally once a day with meals. After a week, the dose of placebo will be increased to 1000 mg (two tablets) daily. After another week, the dose of placebo will be increased to 1500 mg (three tablets) daily.
15827810|NCT04221750|Behavioral|Healthy Lifesylte|Group educational sessions that focus on healthy diet, exercise, and social support once a month
15827811|NCT04221737|Device|APRV. General Electric Healthcare Engstrom ventilator system|APRV consist of an extended time at plateau pressure (a continuous positive airway pressure phase) comprising about 90% of the respiratory cycle, while providing very brief releases to enhance carbon dioxide removal. Time-controlled adaptive method requires interpretation of the expiratory flow curve to assess changes in lung elastance and, therefore, set the Time low to optimize carbon dioxide removal, but not at the expense of alveolar derecruitment and instability.
15827812|NCT04221737|Device|Conventional. General Electric Healthcare Engstrom ventilator system|Lung protective ventilation consist of delivery of low tidal volumes (4-6 ml/kg PBW), high PEEP enough to avoid de-recruitment, titrated according to ARDSNet PEEP/fraction of inspired oxygen (FiO2) table, while avoiding excessive transpulmonary pressure.
15827813|NCT04221724|Other|Multicomponent physical exercise program|"The intervention consists of a combined multicomponent exercise program (EP) carried out for 6 months that includes strength, balance, flexibility and functional exercises aimed to improve functioning on daily life activities. The EP will be divided into two parts:
~The first 3 months the EP aims to restore the physical condition through the multicomponent exercise program. This program will comprise of upper and lower body strengthening exercises, using external weights for 2-3sets of 8-12repetitions at a progressive intensity of 30-50% of 1RM. In addition, static balance and flexibility exercise will be performed.
~From 3th to 6th months, the objective will be to improve autonomy through the functional EP. Strength exercises intensity will be increased to 60-70% of 1-RM, 2-3sets of 8-12repetitions. Attention tasks, temporal space dissociation and dynamic balance exercises will be added to increase the intensity in balance exercises. Flexibility and fine handle will be also performed"
15827814|NCT04221711|Device|Repetitive pulsed magnetic stimulation|"OMNITRON ProMed is a rPMS (repetitive peripheral magnetic stimulation) device used for deep stimulation of muscles and/or neurones (outside the brain). The energy is delivered by way of a special round treatment coil, whose cover material is tested for biocompatibility.
~The OMNITRON ProMed device produces a high-energy impulse field and stimulates tissue, in particular soft tissue, muscles and neurons, by means of repetitive peripheral magnetic stimulation (rPMS). Short, extremely strong magnetic fields in the microsecond range are emitted non-invasively. OMNITRON ProMed works with short-term energy emission at a peak power of up to 60 million watts and a magnetic field strength of up to 100 milliTesla.
~The intensity of treatment can be set between 20 and 100 %. The device automatically adjusts the magnetic field strength and the frequency of the pulses emitted depending on the intensity selected.
~For comfortable transport and application the product is compact and portable."
15827815|NCT04221711|Procedure|Eccentric Calf Muscle Training for Achilles Tendinopathy|"Patients will be asked to stand with their full body weight on the injured leg. From an upright body position and standing with all body weight on the forefoot and the ankle joint in plantar flexion, the calf muscle is then loaded by having the patient slowly lower the heel beneath the forefoot. The calf muscle will only be loaded eccentrically, not concentric. Instead, the non-injured leg is used to get back to the start position. The first set of this exercise is performed in an upright position, followed by a second set with the knee bent to 45°. This regimen is performed 2x per day.
~The patients are told to go ahead with the exercise even if they experienced pain. However, they are told to stop if the pain becomes disabling."
15827816|NCT04221698|Other|Gait retraining|5 gait retraining sessions of continuous feedback in real time during running sessions; using videotape feedback, a digital metronome to increase step rate, and verbal feedback to reduce the tendency to heel strike upon ground contact. Verbal feedback is offered during the 25- to 30-minute running sessions following a series of drills aimed at improving running mechanics.
15827817|NCT04221685|Other|Artpharma|ArtPharma is a unique amide local anesthetic that is currently Used in dentistry Amides has taken over their predecessors esters with their enhanced performance.Each ml Articaine (D.C.I) 40.00 mg hydrochloride, Epinephrine (D.C.I) (tartrate) 0.01 mg
15827818|NCT04221685|Other|Artinibsa|"Powerful local anaesthetic with a short latency time.
~Its high lipid solubility gives it better diffusion through soft tissues and bone and makes it highly effective for infiltrative techniques.Each ml contains:
~Articaine (D.C.I) 40.00 mg hydrochloride, Epinephrine (D.C.I) (tartrate) 0.01 mg"
15827819|NCT04221672|Drug|Terlipressin plus standard care|All the participants received routine care after surgery. Intraoperative 1 mg, and 1 mg q12h from post-operative day 1 through day 4.
15827820|NCT04221672|Other|Standard care|All the participants received routine care after surgery only.
15827842|NCT04221477|Drug|Obinutuzumab|Obinutuzumab will be administered by IV infusion at a dose of 1000 mg at Baseline and Weeks 2, 24, 26, 50 (group 2: placebo), and 52 and subsequently from Week 80 and every 6 months thereafter, based on response.
15827843|NCT04221477|Drug|MMF|MMF willl be administered at a target dose of 2.0 - 2.5 g/day in divided doses through Week 80.
15827844|NCT04221477|Drug|Prednisone|Prednisone 0.5 mg/kg/day (maximum 60 mg/day) will be started on Day 2. Beginning on Day 15, prednisone will be tapered to 5 mg/day and continued until Week 80.
15827821|NCT04221659|Device|Transcranial Direct Current Stimulation|Participants will receive 16 sessions of Transcranial Direct Current Stimulation (tDCS) for 20 minutes each at 2 mA intensity, on alternate days (3 times a week). The current will be delivered via saline-embedded sponge surface electrodes using a battery-powered neurostimulator (TCT-Research, Trans Cranial Technologies, Hong Kong). A small active specific electrode (5x5 cm) will be used to prevent coverage of adjacent areas, resulting in a current density of 0.08 mA / cm². The cathode, reference electrode (5x7cm), will be positioned in the occipital region. These parameters are within the safe limits established in previous human studies.
15827822|NCT04221646|Device|BTL-899|Treatment with study device.
15827823|NCT04221633|Behavioral|Enhancing Early Engagement (E3) webinar|Webinar-based training to provide information regarding evidence-based engagement strategies (e.g., motivational interviewing, McKay's engagement model), trauma, mental health screening, and identifying evidence-based mental health treatments for children.
15827824|NCT04221633|Behavioral|Consultation for E3 training|10 consultation calls with experts in engagement, child trauma, and mental health screening to support the webinar training
15827825|NCT04221620|Device|Zengar Electroencephalogram (EEG) Neurofeedback device|Electroencephalogram (EEG) Neurofeedback is a noninvasive way to allow the central nervous system to self regulate and calm the brain enough to allow the frontal cortex to function in an ideal state, which is the part of the brain that controls important functions including behavior, problem solving, memory, language, emotions, and judgment. EEG Neurofeedback is performed via a musical medley that lasts for about 34 minutes, with baseline numbers taken at the beginning and after the music finishes. During this time, the participant will wear headphones, sensory clips on the ears (3 total), and two sensors on their head while receiving traditional occupational therapy services.
15827826|NCT04221607|Other|Sensate Focus exercise|Structured exercise to enhance intimacy
15827827|NCT04221594|Procedure|Invasive Cardiac Catheterization (ICA)|Invasive functional measurements will be performed to assess the functional significance of specific lesions by means of FFR and CFR, and to test the presence of microvascular disease by means of IMR in all vessels for which the procedures are feasible. In summary, a 5- to 7-F guide catheter without side holes is used to engage the coronary artery and a pressure-temperature sensor-tipped guidewire introduced. The pressure sensor is positioned at the distal segment of a target vessel, and intracoronary nitroglycerine (100-200 mg) administered before each measurement. The best systolic and diastolic phase (located between 30-50%, and 60-75% of the cardiac cycle) will be selected for successive processing as it allows a relative motion free visualization of the main vessels and the myocardium.
15827828|NCT04221594|Procedure|Coronary Computed Tomographic Angiogram (CCTA)|Fasting patients will undergo a test for coronary calcium by CT; calcium scoring analysis will be done post image data acquisition using the manufacturer's software. Nitroglycerine will be administered in all patients (sublingual administration prior to CCTA initiation). CT acquisitions will be prospectively ECG-gated (30-80% of the cardiac cycle). The acquisition begins with a scout scan to identify the borders of the heart to minimize the field of view and exposure to the patient. A bolus of 60 mL nonionic contrast agent is then injected followed by 60 mL of saline at a rate of 4 mL/s to enhance signal from coronary arteries and blood chambers. In case of irregular heart rate, beta-blockers can be provided to keep optimal heart rate ~65-70 bpm. Trans-axial images are reconstructed by means of a filtered back-projection algorithm.
15827829|NCT04221594|Procedure|Dynamic Cardiac Positron Emission Tomography (dPET)|Patients will be asked to fast for 24 hours prior to the test. Before the resting perfusion phase, a single low-dose CT-based transmission scan is acquired for attenuation correction (AC) of all subsequent acquisitions. AC-CT images are automatically registered to the perfusion images, visually verified and manually corrected if necessary. Resting perfusion imaging started with the intravenous injection of a single bolus of 82Rb. Pharmacological stress imaging is obtained after adenosine infusion (140 μg/kg/min) through a peripheral vein, followed by a second dose of 82Rb. Image reconstruction is achieved by means of ordered subset expectation maximization (OSEM) iterative method. The hemodynamic responses to rest/stress tests are collected in terms of mean heart rate, mean blood systolic pressures and diastolic at rest and stress. Dynamic, gated and ungated trans-axial reconstructions are saved in DICOM format for further analysis and processing.
15827830|NCT04221581|Device|Knee prosthesis - FHK ASYMETRIQUE total knee prosthesis|FHK ASYMETRIQUE prosthesis are intended to be implanted in the tibial and femoral regions during total knee arthroplasty in order to restore joint function.
15827831|NCT04221568|Drug|Bupivacaine-fentanyl|local anathetic&analgesic drugs
15827832|NCT04221568|Drug|levobupivacaine-fentanyl|local anathetic&analgesic drugs
15827833|NCT04221555|Drug|Docetaxel, Oxaliplatin, S-1 and Durvalumab|"Neoadjuvant treatment Durvalumab 1120 mg IV on day (D) 1, Docetaxel 50 mg/m2 intravenously (IV) on D1, oxaliplatin 100 mg/m2 IV on D1, S-1 40 mg/m2 bid orally on D1-14, will be administered every three weeks for three cycles.
~Surgery
~Adjuvant treatment After 4-6 weeks from surgery, S-1 40 mg/m2 bid orally on D1-28 plus durvalumab 1120 mg on D1 and D22 will be administered every 6 weeks for 12 months as an adjuvant treatment."
15827834|NCT04221555|Drug|Durvalumab and Tremelimumab|"Neoadjuvant treatment Durvalumab 1500 mg IV and tremelimumab 75 mg IV on D1 will be administered every four weeks for three cycles.
~Surgery
~Adjuvant treatment After 4-6 weeks from surgery, durvalumab 1500 mg on D1 will be administered every 4 weeks for 12 months as an adjuvant treatment."
15827835|NCT04221542|Drug|AMG 509|AMG 509 administered as an intravenous (IV) infusion in subjects with Metastatic Castration-Resistant Prostate Cancer (mCRPC).
15827836|NCT04221529|Drug|Atezolizumab|1200 mg i.v. on day 1 of each cycle
15827837|NCT04221516|Drug|Camrelizumab|Camrelizumab 200mg every 21 days (3 weeks), from 4 to 12 weeks after the completion of radiotherapy.
15827838|NCT04221503|Drug|Niraparib|Niraparib ([3S]-3-[4-{7-(aminocarbonyl)-2H-indazol-2-yl} phenyl] piperidine [tosylate monohydrate salt]) is an orally available, potent, highly selective poly (adenosine diphosphate [ADP]-ribose) polymerase (PARP) -1 and -2 inhibitor. The niraparib drug product is provided as 100-mg capsules filled with a dry blend of niraparib tosylate monohydrate, lactose monohydrate, and magnesium stearate in a hard gelatin capsule.
15827839|NCT04221503|Device|Optune|"Optune, which is manufactured by Novocure, is a portable battery or power supply operated device which produces alternating electrical fields, called tumor treatment fields (TTFields) within the human body. TTFields are applied to the patient by electrically-insulated surface transducer arrays. TTFields disrupt the rapid cell division exhibited by cancer cells."
15827845|NCT04221477|Drug|Placebo|Placebo matching obinutuzumab will be administered by IV infusion at baseline and Weeks 0, 2, 24, 26, 50 and 52 and subsequently from Week 80 and every 6 months thereafter based on response.
15827846|NCT04221477|Drug|Methylprednisolone|Methylprednisolone 80 mg IV will be administered as predmedication prior to infusions.
15827847|NCT04221477|Drug|Acetaminophen|Acetaminophen 650-1000 mg will be administered as premedication prior to infusions.
15827848|NCT04221477|Drug|Diphenhydramine|Diphenhydramine 50 mg will be administered as premedication prior to infusions.
15827849|NCT04221464|Biological|biological collection|Blood samples collected before any treatment (if chemotherapy for example), at every surgery, one month after surgery, at progression
15827850|NCT04221464|Other|Tissues collections|Tumours and not tumours tissues will be collected before any treatment (if chemotherapy for example), at every surgery, one month after surgery, at progression
15827853|NCT04221438|Drug|Binimetinib|Given PO
15827854|NCT04221438|Procedure|Computed Tomography|Undergo PET/CT
15827855|NCT04221438|Procedure|Conventional Surgery|Undergo surgery
15827856|NCT04221438|Drug|Encorafenib|Given PO
15827857|NCT04221438|Other|Fluorothymidine F-18|Given IV
15827858|NCT04221438|Procedure|Positron Emission Tomography|Undergo PET/CT
15827859|NCT04221425|Procedure|virtual reality rehabilitation system (VRRS)|experimental group is equipped with a telerehabilitation system which comprises a tablet (VRRS tablet) and a set of inertial magnetic sensors. participants are invited to follow a daily rehabilitation exercise program provided via VRRS tablet
15827860|NCT04221425|Procedure|standard care|participants in the control group are invited to follow a daily rehabilitation exercise program and indications for the recovery as illustrated in the dimission booklets drawn up by the rehabilitation unit
15827861|NCT04221412|Drug|JNJ-53718678|JNJ-53718678 will be administered as directed by treating physician.
15827862|NCT04221399|Drug|DWP16001|Tablets, Oral, Once daily, Single dose
15827863|NCT04221399|Drug|DWP16001|Tablets, Oral, Once daily, Multiple dose
15827864|NCT04221386|Behavioral|Melodic Intonation Therapy (MIT)|Subjects will receive at least 6 MIT sessions in group of 3-5 subjects. In the sessions, experimenter will sing songs with the subjects. Songs used in the intervention are familiar to elderly and are rewritten and embedded with everyday phrases and vocabularies. The whole intervention will span 3-4 weeks.
15827865|NCT04221373|Device|Ekso™ powered exoskeleton|Powered exoskeletal-assisted walking (EAW) for early training
15827866|NCT04221373|Other|Standard of care|Participants will receive standard of care of acute inpatient rehabilitation.
15827867|NCT04221360|Drug|CKD-375|Test drug, QD, PO
15827868|NCT04221360|Drug|D390|Reference drug, QD, PO
15827869|NCT04221347|Other|blood sampling|blood samples will be taken in specified time points
15827870|NCT04221334|Device|Electric Toothbrush|Electric Toothbrush used to remove dental plaque and resolve gingivitis
15827871|NCT04221334|Other|oral health care application|phone application that shows the user brushing efficiency real time
15827872|NCT04221321|Drug|Atorvastatin 40 mg|Atorvastatin 40 mg
15827873|NCT04221321|Drug|Tegoprazan 50 mg|Tegoprazan 50 mg tablet
15827874|NCT04221321|Drug|RAPA114|RAPA114 tablet
15827875|NCT04221308|Device|Single port laparoscopic systems|The first assistant handles the scope from the patient's right side. The second assistant, who is positioned between the legs of the patient, inserts a uterine manipulator (Rumi System; Cooper Surgical, CT). At the beginning of the surgery, a 1.5 to 2.5 cm vertical incision is made within the umbilicus using the open Hasson approach. After the bottom retractor ring of the wound retractor component of the Octo-Port is inverted (DalimSurgNet, Seoul, Korea), it is inserted through the incision deep in the peritoneum. Carbon dioxide is insufflated through the gas valve of the Octo-Port to maintain intra-abdominal pressure at 10 to 12 mm Hg. Through the 10 mm channels of the Octo-Port, a 10 mm, 30° rigid laparoscope is introduced. Rigid laparoscopic instruments are introduced through the 5 mm channels of the Octo-Port. The utero-ovarian ligament or infundibulopelvic ligament, uterine vessels, and uterine ligaments are transected by using the 5 mm LigaSure vessel sealer device
15827876|NCT04221295|Behavioral|Exercise Group|Previously described in the arm/group descriptions.
15827877|NCT04221282|Drug|Zebinix|ESL will be initiated by the investigator in patients as a first line monotherapy or adjunctive therapy. ESL will be prescribed according to the usual care. Posology and method of administration of ESL are defined by the summary of product characteristics. Then, data on the efficacy of ESL will be collected.
15827878|NCT04221269|Behavioral|Enhanced Treatment as Usual|Routine community care plus assessment feedback reports to clinicians.
15827879|NCT04221269|Behavioral|Coping Long-term with Active Suicide Program for Schizophrenia|Adjunctive psychosocial intervention for suicide prevention involving in person, family, and phone sessions.
15827880|NCT04221256|Drug|Administration of SSRI escitalopram|Participants will be administered 5, 10 or 20mg of SRRI escitalopram prior to paired associative stimulation
15827881|NCT04221256|Behavioral|Paired Associative stimulation|Participants will receive paired associative stimulation (transcranial magnetic stimulation and peripheral nerve stimulation) with an inter-stimulus interval length known to modulate corticospinal excitability.
15827882|NCT04221256|Drug|Administration of Placebo|Participants will be administered a placebo prior to paired associative stimulation
15827883|NCT04221243|Device|3D printed space maintainer by NextDent Ortho Rigid|Biocompatible 3D printing material
15827884|NCT04221243|Device|Conventional Band and Loop|metal space maintainer
15827885|NCT04221230|Drug|BTRX-335140|Active Drug
15827886|NCT04221230|Drug|Placebo|Placebo
15827887|NCT04221217|Drug|Icosapent|Icosapent (MND-2119) capsules.
15827926|NCT04220983|Radiation|MR-Guided Prostate SBRT|Prostate SBRT has become a standard of care for the treatment of localized prostate cancer. Radiation is delivered to the prostate and seminal vesicles in 5 treatment sessions (fractions). Doses ranging from 35-45 Gy in 5 fractions have demonstrated good outcomes with acceptable toxicity when planning is delivered appropriately.
15827927|NCT04220970|Other|BIA-ALCL|Observational : no intervention
15827888|NCT04221204|Drug|Highly selective FGFR1-3 inhibitor|All subjects in each cohort will receive a single oral dose of 3D185, followed by a 7-day washout period (i.e. single-dose PK study period). Then, subjects will receive consecutive daily doses (Once daily [QD], 28 days/cycle) until disease progression, death, unacceptable toxicity, or withdraw of informed consent, whichever comes first. The dose limiting toxicity (DLT) evaluation period includes the single-dose PK study period and the first treatment cycle (within 35 days after the first dose). The enrolled subjects will be sequentially assigned to the planned dose cohorts according to the protocol and receive 3D185 treatment to observe the occurrence of DLT.
15827889|NCT04221191|Drug|Dimethyl Fumarate|DMF as prescribed as standard of care.
15827890|NCT04221191|Other|PSP|PSPs is to support patient care.
15827891|NCT04221178|Other|Cessation of continuous matinenace therapy|Cessation of maintenance therapy for participants in sustained MRD-negative remission while under careful observation
15827892|NCT04221165|Drug|Opioids|Opioids will be prescribed as per institutional standards.
15827893|NCT04221165|Drug|PAiN - multimodal analgesia|PAiN: Pregabalin, Acetaminophen, Naproxen, pantoprazole magnesium
15827894|NCT04221152|Drug|Empagliflozin Tablets|The administration is oral administration with water before or after breakfast.
15827895|NCT04221139|Behavioral|Virtual Reality games|Participants will play the following four virtual reality games for 15 minutes each: Beat Saber, Holopoint, Hot Squat, and Relax Walk.
15827896|NCT04221126|Device|TMFI|Tixel rapidly transfer thermal energy by a metallic pyramid tip that enable skin contact through integrated pulsed movements. The rapid heating dehydrates he epidermis and superficial dermis and creates micropores with no coagulative damage of surronding tissue.
15827897|NCT04221126|Drug|ALA cream|ALA compounded in a cream
15827898|NCT04221126|Drug|ALA gel|ALA compounded in a gel
15827899|NCT04221113|Procedure|physiotherapy|Two protocols have been described for physiotherapy of post extensor tendon injuries. one is immobilization till 3 weeks and than gradual increase in active motion of hand. The second protocol is early active motion. this would be done under senior physiotherapist.
15827900|NCT04221100|Device|Radiograph interpretation for pulmonary abnormalities|"The pulmonary abnormalities detected by xrAI and included in the definition of abnormality are as follows: any linear scar or fibrosis, atelectasis, consolidation, abscess or cavity, nodule, pleural effusion, severe cases of emphysema and COPD (mild cases with hyperinflation but not significant emphysema are not flagged), pneumothorax.
~Participants in the treatment group will interpret 500 images presented alongside the results of xrAI's processing in a dark room and asked to categorize each image into one of the following categories: lungs are clear, at least one pulmonary abnormality is present, not sure.
~Participants in the control group will be asked to interpret the same 500 images as the treatment group but without xrAI's analysis."
15827901|NCT04221087|Drug|Placebos|Sugar water based on same ml dosing of intervention arm drug
15827902|NCT04221087|Drug|Dexamethasone Oral|0.6mg/kg/dose - single oral dose administration to intervention arm
15827903|NCT04221074|Procedure|PECS II versus ESP|compare between :ultrasound guided Pectoralis nerve(pecs) II block or erector spinae plane (ESP) block in surgical treatment for gynecomastia patients under general anaesthesia.
15827904|NCT04221061|Drug|18F-FluorThanatrace|18F-FluorThanatrace is a novel radiopharmaceutical which measure PARP-1 expression using a Positron Emission Tomography (PET/CT) scan.
15827905|NCT04221048|Other|Retrospective observational|Pregnancy scores will be based on information obtained from the relevant clinical letter and clinical notes
15827906|NCT04221035|Drug|Vincristine|1.5 mg/m^2 (max dose 2 mg)
15827907|NCT04221035|Drug|Carboplatin|750 mg/m^2
15827908|NCT04221035|Drug|Etoposide|175 mg/m^2
15827909|NCT04221035|Drug|Cyclophosphamide|1050 mg/m^2
15827910|NCT04221035|Drug|Vindesine|3 mg/m^2/day (max dose 6 mg)
15827911|NCT04221035|Drug|Dacarbazine|200 mg/m^2/day
15827912|NCT04221035|Drug|Ifosfamide|1500 mg/m^2/day
15827913|NCT04221035|Drug|Doxorubicin|30 mg/m^2/dose
15827914|NCT04221035|Drug|Busulfan|< 9kg: 1.0 mg/kg/dose 9 kg to < 16 kg : 1.2 mg/kg/dose 16 kg to 23 kg : 1.1 mg/kg/dose >23 kg to 34 kg: 0.95 mg/kg/dose >34 kg: 0.8 mg/kg/dose Infusion IV over 2 hours Administration every 6 hours for a total of 16 doses
15827915|NCT04221035|Drug|Melphalan|140 mg/m^2/dose IV short infusion (15'), at least 24 h after the last busulfan dose
15827916|NCT04221035|Drug|Thiotepa|300 mg/m^2/day over 2 hours
15827917|NCT04221035|Radiation|Radiotherapy|21.6 Gy 21.6 Gy + boost de 14.4 Gy
15827918|NCT04221035|Drug|Dinutuximab Beta|Patients >12 kg are dosed based on the BSA: 10 mg/m^2/day Patients ≤ 12 kg are dosed according to their body weight: 0.33 mg/kg/day
15827919|NCT04221035|Drug|Cisplatin|80 mg/m^2/24h
15827920|NCT04221022|Other|Light physical activity|Each session started with leisure walk, duration of which was set to 35 minutes. Frequency set for the session was that each individual of the group had to walk for five days a week for total of six weeks. (total 30 days in six weeks)
15827921|NCT04221022|Other|Moderate physical activity|Each session started with brisk walk, duration of which was set to 30 minutes. Frequency set for the session was that each individual of the group had to walk for five days a week for total of six weeks. (total 30 days in six weeks)
15827922|NCT04221022|Other|Vigorous physical activity|Each session started with jogging, duration of which was set to 15 minutes. Frequency set for the session was that each individual of the group had to walk for five days a week for total of six weeks. (total 30 days in six weeks)
15827923|NCT04215094|Diagnostic Test|postoperative fever, serum procalcitonin, C-reactive protein and white blood cell coun|All patients in Intracranial Infection group were cured with antibiotic treatment
15827924|NCT04221009|Behavioral|MI and CBT 4-session manualized intervention|This is a 4-session intervention derived from Motivational Interviewing and Cognitive Behavior Therapy and adapted with cognitive accommodations.
15827925|NCT04220996|Drug|Vortioxetine|Vortioxetine 10 and 20 mg/day, tablets, orally Patients will receive 10 mg vortioxetine once daily for the first week. At Visit 2, the dose will be increased to 20 mg/day. The dose may subsequently be adjusted to 10 or 20 mg/day at scheduled or unscheduled visits depending on patient's response as per investigator judgment.
15827928|NCT04220957|Other|Digital Impression Technique|Digital impressions of both arches will be taken by using an intraoral scanner (Trios 3, 3Shape, Denmark) by adhering to the scanning pattern recommended by the company for routine diagnosis and recording.
15827929|NCT04220957|Other|Conventional Impression Technique|Conventional Impression Technique of both arches will be taken with alginate (Orthoprint, Zhermack) on conventional stainless steel impression trays.
15827930|NCT04220944|Drug|Sintilimab|Sintilimab (200mg) was administered intravenously over 30-60 min every 3 weeks.
15827931|NCT04220944|Procedure|Microwave Ablation|The ablation area should covered at least two thirds the size of the nodules.
15827932|NCT04220944|Procedure|TACE|Patient was treated with epirubicin lipiodol emulsion(Epirubicin 40mg, Lipiodol 10ml).Embolic materials such as gelfoam or microsphere was aslo administered until complete stasis in segmental or subsegmental arterial branches.
15827933|NCT04220931|Drug|botulinum toxin injection|injection of Botulinum toxin A 100 UI, single dose administration, in the major papilla, in the Oddi sphincter, during upper gastrointestinal endoscopy.
15827934|NCT04220892|Drug|Pembrolizumab|200 mg intravenous (IV) every 3 weeks
15827935|NCT04220892|Drug|Pemetrexed|900 mg/m^2 IV every 3 weeks. Supportive medications of ibuprofen, folic acid, vitamin B12, and dexamethasone.
15827936|NCT04220892|Drug|Abemaciclib|150 mg twice a day, by mouth.
15827937|NCT04220866|Drug|Ulevostinag|IT injection
15827938|NCT04220866|Biological|Pembrolizumab|IV infusion
15827939|NCT04220853|Diagnostic Test|Rhinomanometry in patients after septoplasty and/or turbinoplasty|Rhinomanometry is an examination used to assess changes in resistance and airflow in patients after septoplasty and/or turbinoplasty.
15827940|NCT04220853|Diagnostic Test|Acoustic rhinometry in patients after septoplasty and/or turbinoplasty|Acoustic rhinometry is an examination used to assess changes in the cross-sectional area of the nasal passage in patients after septoplasty and/or turbinoplasty.
15827941|NCT04220840|Procedure|Damage control strategy|"The damage control strategy constitutes a two stage procedure.
~Emergency surgery:
~limited resection oft he diseased colonic segment with oral and aboral blind closure, abdominal lavage, temporary vacuum assisted abdominal closure
~Second look surgery (48-72 hours later):
~reexploration with
~definite reconstruction (Colorectal anastomosis -/+ diverting ileostomy vs. end colostomy)
~lavage, vacuum assisted abdominal closure, third look 72 hours after emergency surgery"
15827942|NCT04220827|Drug|Paclitaxel|Given IP
15827943|NCT04220814|Radiation|MRI|MRI protocol is different, a little bit longer than MRI in routine for patients. For healthy volunteer, a specific MRI for this study is done
15827944|NCT04220814|Other|Electrophysiology|Electrophysiology will be done during routine visits for patients and during inclusion visit to healthy volunteers
15827945|NCT04220801|Drug|ZM-H1505R|Single oral doses of 300, 450, 600, 750, and 900 mg of ZM-H1505R or placebo and multiple oral doses of 450, 600, and 750 mg of ZM-H1505R or placebo will be administered in a fasted state, or in the case of Cohort 3 (Part 1), a second dose of 600 mg will be administered in the fed state. During each SAD and MAD dosing period, 2 subjects in each cohort will receive placebo instead of ZM-H1505R. The dose levels may be adjusted based on the safety and tolerability obtained from the previous cohort.
15827946|NCT04220788|Other|Enhanced pharmacist service|Calculation of cardiovascular risk by an online tool for discussion on the CVD risk. Pharmacist will also provide ducation on cardiovascular risk factors and healthy lifestyle. Any prescription adaptation(s), and/or recommendations where necessary to meet lipid, blood pressure and glycemic control targets and smoking cessation will be initiated
15827947|NCT04220788|Other|Usual care|Participants in the arm will receive their care from their respective nurse, doctor or pharmacists as per usual clinic practice
15827948|NCT04220775|Drug|Bintrafusp Alfa|Given IV
15827949|NCT04220775|Other|Quality-of-Life Assessment|Ancillary studies
15827950|NCT04220775|Other|Questionnaire Administration|Ancillary studies
15827951|NCT04220775|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15827952|NCT04220762|Drug|WIN-1001X|"This study has been designed as a randomized, double-blind, and placebo-controlled study.
~Once the patients who have voluntarily singed an informed consent form are enrolled in this study, their eligibilities for the study are assessed and those who have satisfied the inclusion/exclusion criteria are randomized to the test group 1 (400mg), 2 (800mg), and 3 (1200mg), or the control group (placebo group) in a ratio of 1:1:1:1. The randomized patients are administered 3 tablets of the investigational product twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated."
15827953|NCT04220762|Drug|Placebo|"This study has been designed as a randomized, double-blind, and placebo-controlled study.
~Once the patients who have voluntarily singed an informed consent form are enrolled in this study, their eligibilities for the study are assessed and those who have satisfied the inclusion/exclusion criteria are randomized to the test group 1 (400mg), 2 (800mg), and 3 (1200mg), or the control group (placebo group) in a ratio of 1:1:1:1. The randomized patients are administered 3 tablets of the investigational product twice a day for 12 weeks and the safety follow-up should be carried out for 2 weeks after administration of the investigational product is terminated."
15827954|NCT04220749|Radiation|Radiation|Standard of Care: Radiation +/- Chemotherapy
15827955|NCT04220749|Procedure|Trans-Oral Surgery (TOS) + Neck Dissection|Trans-Oral Surgery (TOS) + Neck Dissection (plus radiation, if required)
15827956|NCT04220736|Diagnostic Test|Computation of quantitative flow ratio|Computation of QFR was performed offline, using AngioPlus system(Pluse medical imaging technology, Shanghai, China). In the first step, 2 diagnostic angiographic projections before PCI, at least 25° apart, were selected and 3D reconstruction of the interrogated vessel without its side branches was performed. Then, the software computed the QFR.
15827957|NCT04220723|Other|Frailty Assessment|"Liver Frailty Index measurements:
~Grip strength: the average of three trials, measured in the subject's dominant hand using a hand dynamometer
~Timed chair stands: measured as the number of seconds it takes to do five chair stands with the subject's arms folded across the chest
~Balance testing: measured as the number of seconds that the subject can balance in three positions (feet placed side-to-side, semitandem, and tandem) for a maximum of 10 seconds each."
15827994|NCT04220476|Drug|Palbociclib 125mg|Patients randomized to arm 2 will start letrozole alone, and add palbociclib on day 21, after completion of I-SBRT.
15828122|NCT04219449|Diagnostic Test|Platelet aggregation by ADP and arachidonic acid|measuring platelet aggregation drawn on citrated blood sample
15828123|NCT04219436|Procedure|esthetic crown leghthening|two different suturing technique used for flap closure after esthetic crown lengthening
15827958|NCT04220723|Other|Functional Capacity Assessment|Shuttle Walk Test: The patient is required to walk around two cones set 9 metres apart (so the final track is 10 metres) in time to a set of auditory beeps played on a CD. Initially, the walking speed is very slow, but each minute the required walking speed progressively increases. The patient walks for as long as they can until they are either too breathless or can no longer keep up with the beeps, at which time the test ends. The number of shuttles is recorded. Each shuttle represents a distance of ten metres (i.e each time the patient reaches a cone is 1 shuttle).
15827959|NCT04220710|Diagnostic Test|DNA extraction and methylation detection|DNA extraction and methylation detection
15827960|NCT04220697|Other|electroencephalography (EEG)|recording of resting state EEG using 64 surface electrodes
15827961|NCT04220697|Other|questionnaires|Hospital Anxiety Depression Scale (HADS) Neuropathic Pain questionnaire (DN4) Brief Pain Inventory (BPI) Fatigue Assessment Scale (FAS)
15827962|NCT04220697|Other|high frequency electrical stimulation of the forearm skin (HFS)|HFS consists of transcutaneous electrical stimuli delivered as 42 Hz trains (pulse width: 2 ms) lasting 1 s. The trains are repeated 12 times. Each train is separated by 10 seconds.
15827963|NCT04220697|Other|cutaneous mechanical pinprick stimulation|Mechanical pinprick stimuli will be applied manually by the operator on the skin using a mechanical stimulator (maximum weight 128 mN).
15827964|NCT04220684|Drug|Cytarabine|Given IV
15827965|NCT04220684|Drug|Cytarabine Hydrochloride|Given IV
15827966|NCT04220684|Drug|Decitabine|Given IV
15827967|NCT04220684|Drug|Fludarabine|Given IV
15827968|NCT04220684|Drug|Fludarabine Phosphate|Given IV
15827969|NCT04220684|Biological|Membrane-bound Interleukin-21-Expanded Haploidentical Natural Killer Cells|Given via infusion
15827970|NCT04220671|Biological|measles vaccine|Measles vaccine, Edmonston-Zagreb strain, 0.5 ml administered as a subcutaneous injection
15827971|NCT04220671|Other|Saline|0.9% NaCl
15827972|NCT04220658|Other|Biomarker study|Biomarkers of aging including NAD+ levels in whole blood, interleukins, inflammatory cytokines, growth factors, omega-3 polyunsaturated fatty acids, and patterns in DNA methylation
15827973|NCT04220645|Other|Opportunstic treatment|opportunistically treating HCV infection immediately when hep C patients are hospitalized for acute care in psychiatric, addiction treatment or somatic wards
15827974|NCT04220645|Other|Standard of care|Referral at discharge
15827975|NCT04220632|Drug|Itacitinib|at the protocol-defined dose administered orally once daily (QD) plus corticosteroids.
15827976|NCT04220632|Drug|Prednisone|Oral prednisone may be used to begin standard corticosteroid background treatment at the investigator's discretion, at a dose equivalent to methylprednisolone 2 mg/kg per day.
15827977|NCT04220632|Drug|Methylprednisolone|Oral prednisone may be used to begin standard corticosteroid background treatment at the investigator's discretion, at a dose equivalent to methylprednisolone 2 mg/kg per day.
15827978|NCT04220619|Diagnostic Test|Tranesophageal Echocardiography|RescueTEE during ACLS versus Conventional ACLS
15827979|NCT04220606|Drug|Glyceryl trinitrate (I.V. infusion 0.5 µg/kg/min over 20 min)|
15827980|NCT04220593|Other|tDCS associated with Tcog|2mA-intensity aETCC will be applied to the left dorsolateral prefrontal cortex (CPFDL) region for 20 min, three times a week (every other day) over a one-month period, totaling 12 sessions. In each session activities aimed at stimulating cognition will be applied over the 20 minutes.
15827981|NCT04220580|Other|Blood samples|3 blood samples, two for RNA and one for metabolites are taken 5 minutes before a Cold Pressor Test and again 1 hour after the Cold Pressor Test.
15827982|NCT04220567|Other|Experimental: Exercise and Patient-centred education|"An eight-week programme based on 24 sessions of exercise supervised by a physiotherapist. Exercise will be carried out three times a week. Once a week the exercise session is performed autonomously by patient at home (according to the physiotherapist's recommendations).
~Patient-centred Education will follow the principles of transformative learning & incorporate patients' narratives. It will precede 9 of the 24 exercise sessions and be delivered by the same physiotherapist"
15827983|NCT04220567|Other|Active Comparator: Exercise|An eight-week programme based on 24 sessions of exercise supervised by a physiotherapist. Exercise will be carried out three times a week. Once a week the exercise session is performed autonomously by patient at home (according to the physiotherapist's recommendations).
15827984|NCT04220554|Other|Improved support by health-care professionals|Improved support to patients prescribed topical antipsoriatic drugs
15827985|NCT04220541|Behavioral|Motor learning based exercise|Symptomatic exercise
15827986|NCT04220528|Drug|Capecitabine/Tiggio|"Drug: Capecitabine/Tiggio
~Radical chemoradiotherapy：Induction chemotherapy plus Concurrent chemoradiotherapy
~Induction chemotherapy：Gemcitabine (1000mg/m2) D1 D8+ nida platinum (80mg/m2) D2 q3w ×3cycle
~Concurrent chemoradiotherapy：IMRT was used for radiotherapy, during which D1 and D22 were given two cycles of single drug concurrent chemotherapy with nidapatin (100mg/m2)."
15827987|NCT04220515|Biological|Inactivated Poliomyelitis Vaccine Made From Sabin Strain|Type I D antigen 30DU;Type II D antigen 32DU;Type III D antigen 45 DU
15827988|NCT04220502|Drug|Magic Shave Powder Gold|Depilatory Cream for facial hair removal
15827989|NCT04220502|Device|Traditional Shaving Methods|Continued facial hair removal using traditional razors
15827990|NCT04220489|Drug|Ketamine|Intraoperative ketamine and post operative 48 hour ketamine infusion with a standardized general anesthesia protocol.
15827991|NCT04220489|Drug|Placebo Comparator|Participants will receive a 1 mg/kg dose of intravenous saline 15 minutes after induction of general anesthesia. Thereafter, a continuous infusion of 0.20 mg/kg/hr saline with a maximum dose of 20 mg/hr will be run to conclude at 48 hours after the end of the surgery (fascial closure)
15827992|NCT04220476|Radiation|Stereotactic Body Radiation Therapy (SBRT) (50GY in 5 fractions)|Patients randomized to arm 2 will start letrozole alone, and add palbociclib on day 21, after completion of I-SBRT. They will undergo tumor Immunogenic-SBRT(I-SBRT) days 1-12 (+/-2 days, to enable inclusion of holidays). During the week preceding day 1, they will undergo simulation and planning for radiotherapy. Each oligometastatic lesion will be treated with I-SBRT every 48 hours. Treatment may be given daily (to keep the total I-SBRT treatment time to ≤ 12 days) and lesions targeted with I-SBRT will thus be alternated each day to accommodate for the 48 hour interval between fractions
15827993|NCT04220476|Drug|Letrozole 2.5Mg Tab|All patients start standard therapy with oral letrozole (Femara), day 1 of the study.
15827995|NCT04220463|Other|Hypnosis + NIV|For the hypnosis group, hypnotic support is set up by an IDE previously trained and dedicated during the implementation of the NIV. The dedicated IDE will be presented before the start of the NIV setup procedure and will start the hypnosis session a few minutes before the mask is put on. The procedure for setting up the NAV may begin after agreement from the dedicated IDE.
15827996|NCT04220463|Other|NIV|In the control group, in order to preserve the knowledge of the evaluator, the IDE dedicated to hypnosis is present in the service but does not intervene in the care so as not to be tempted to involuntarily put hypnosis in place. The assessor will be chosen from the two other teams present in the other two modules (each module is a seven-bed unit and has no physical communication with the other two) after the start of the procedure for setting up the NIV, with or without hypnosis, in order to be certain that he had no visual contact with the patient and the caregivers present before the evaluation. The implementation of the NAV will take place as usually carried out in the service.
15827997|NCT04220450|Diagnostic Test|T1 mapping on Cardiovascular Magnetic Resonance Studies|On clinically indicated Cardiovascular Magnetic Resonance Imaging Studies, native T1-times and extracellular volume will be determined
15827998|NCT04220437|Other|no interventin|Our stusy analysed the images obtained from ISR patients, no extra intervention was given based on this study.
15827999|NCT04220424|Diagnostic Test|MR and Histopathology images based prediction of molecular pathology and patient survival|MR and Histopathology images based prediction of molecular pathology and patient survival in gliomas by leverage artificial intelligence algorithms
15828000|NCT04220411|Drug|AR100DP1|topical ointment
15828001|NCT04220398|Drug|Neoadjuvant chemotherapy combined with hormone therapy|Docetaxel 75mg/m2 IV (every 3 weeks) +Prednisone 5mg BID orally + HT (Bicalutamide Tablets, 50mg QD orally; Goserelin, 3.6mg, subcutaneous injection, q28d), 4-6 cycles
15828002|NCT04220398|Drug|Neoadjuvant hormone therapy|HT (Bicalutamide Tablets, 50mg QD orally; Goserelin, 3.6mg, subcutaneous injection, q28d), 3-6 cycles
15828003|NCT04220398|Procedure|Radical Prostatectomy (RP)+ extended lymph node dissection|"Radical Prostatectomy (RP)+ extended lymph node dissection: Within three months after neoadjuvant treatment.
~Treatment after prostatectomy: There will not have any drug treatment after surgery until disease progression.
~Pelvic lymph node dissection is required to reach the level of bilateral iliac artery. If the postoperative pathology indicated positive incisional margin or pelvic lymph node metastasis, pelvic adjuvant radiotherapy should be performed within 3 months after surgery."
15828004|NCT04220385|Other|Group A|Subjects will perform following exercises, Single Leg Extension, Arm and Leg Lift, Balance Bridge, Single-Leg Twist, Single Leg Reach, Sideways Leg Lift, Single Arm Stand, Torso Twists and Plank exercise with minimum one set and maximum two sets. 30 seconds will be rest time between each set. Subjects will be encouraged to increase the number of repetitions after every 2 weeks, except in Plank exercise in which holding position time will be initially 30 seconds in each set and will be encouraged to increase holding time after every 2 weeks.
15828005|NCT04220385|Other|Group B|Subjects will perform Side Bridge, Bird Dog and Beginner Curl-up exercise in the first three weeks and Side Bridge, Bird Dog and Intermediate Curl-up exercise in the last three weeks. Repetitions per set will be 5, 4, 3 in first two weeks, 7, 6, 5 in third and fourth weeks and 9, 8, 7 in last two weeks. 8-10 seconds will be holding time in each repetition. 30 seconds will be rest time between each set
15828006|NCT04220372|Drug|Tongxinluo|Provided by Shijiazhuang Yiling Pharmaceutical CO., LTD
15828007|NCT04220372|Drug|Placebo|Provided by Shijiazhuang Yiling Pharmaceutical CO., LTD
15828008|NCT04220359|Device|non-invasive monitoring|Prospective monitoring with retrospective big-data analysis
15828009|NCT04220346|Other|Tablet group|Children in the Tablet group started to play the game with Tablet about 5-10 minutes before circumcision, and continued to play the game during the whole procedure.
15828010|NCT04220333|Behavioral|Mandalas of Emotions|Application of mandalas during 15 minutes
15828011|NCT04220333|Behavioral|Control|"Participants were requested to lie down, relax and pay attention to your breath."
15828012|NCT04220320|Diagnostic Test|Vaginal examination.|Cervical properties as evaluated by a vaginal examination.
15828013|NCT04220320|Diagnostic Test|Transvaginal sonography.|Cervical length as evaluated by a transvaginal sonography.
15828014|NCT04220307|Biological|AK-104|Subjects will receive AK104 by intravenous administration
15828015|NCT04220294|Procedure|Subcutaneous tissue closure|Subcutaneous tissue closure with 2-0 vicryl suture.
15828016|NCT04220281|Drug|Propofol|propofol infusion during surgery
15828017|NCT04220281|Drug|Nitroglycerin|nitroglycerin infusion during surgery
15828018|NCT04220255|Device|Liberty677MY Multifocal IOL|multifocal intraocular lens (IOL)
15828019|NCT04220242|Other|Video recordings with analysis thereafter applied|Recordings of surgical assessments in order to develop a model for Artificial Intelligence analysis
15828020|NCT04220242|Other|Examination of microsections of tissue excised for the purposes of cancer resection|Microscopic examination including by near-infrared examination of some of the tissue excised for the purposes of cancer resection to examine cellular mechanisms of fluorescence uptake and distribution
15828021|NCT04220242|Other|Cancer organoid development and testing|Some tissue will be taken from the specimens excised for the purposes of the cancer operation to develop experimental models of cancer tissue to allow examination of mechanisms of uptake and distribution of the fluorophores in cancer
15828022|NCT04220229|Drug|Cabozantinib S-malate|Given PO
15828023|NCT04220229|Radiation|Radiation Therapy|Undergo standard of care radiation therapy
15828024|NCT04220216|Other|H4H fitness program|4 weekly, 1 hour exercise sessions
15828025|NCT04220203|Drug|Tucatinib|300 mg orally two times per day
15828026|NCT04220203|Drug|Capecitabine|1000 mg/m^2 orally two times per day on Days 1-14 of each 21-day cycle
15828027|NCT04220203|Drug|Trastuzumab|Loading dose of 8 mg/kg into the vein (IV; intravenously), followed by 6 mg/kg IV once per 21-day cycle
15828028|NCT04220190|Biological|RAPA-501 Autologous T cells|TREG/Th2 cells
15828119|NCT04219462|Device|sham extracorporeal shock wave|twenty men will receive sham treatment underwent identical therapy with ESWT application with a similar appearance and sound as the active extracorporal shock wave therapy (ESWT), although shock wave propagation to the tissue wills be blocked by a metal plate that will inserted into the sham applicator + sildenafil 5mg once daily for 3 months.
15828120|NCT04219449|Diagnostic Test|PT|measuring PT drawn on citrated blood sample
15828029|NCT04220177|Device|SETA LATECBA Stent Grafts|ABK model is a bifurcated polyester graft partially corrugated which is sutured at the proximal end (renal) to a balloon expandable 316 L stainless steel stent. The proximal half part of the stent is uncovered by polyester graft providing the anchoring to the healthy aorta wall when the device is implanted, as well as the perfusion of the renal arteries. The remaining half part is covered by polyester graft providing sealing of the aneurysm when it is expanded upon on the graft fabric and aneurysm neck. The distal end of each branch has the anchorage site for sealing after the connection with the iliac extensions RIK. The diameter of the anchorage site varies with the different ABK codes. The end of one branch is cone-shaped after the anchoring diameter with the purpose of promoting insertion of iliac extension RIK. The connection to iliac arteries is achieved by completing the aortic trunk ABK with 2 iliac extensions RIK.
15828030|NCT04220164|Other|Education and inform the optimal threshold of LDL-C levels|Physicians educate patients and provide a clear information about optimal LDL-C value according to individual patient's condition according to current guidelines
15828031|NCT04220151|Genetic|DNA methylation|DNA methylation will be measured by real time polymerase chain reaction
15828032|NCT04220138|Procedure|Anterior chamber illumination in cataract surgery|This will be a prospective interventional case series, patients with cataract and poor red reflex will undergo phacoemulsification assisted by anterior chamber illumination to overcome the problem of poor red reflex.
15828033|NCT04220125|Drug|Ketamine Group|Ketamine intravenous administration 0.5 mg/kg over 40 minutes.
15828034|NCT04220125|Drug|Midazolam injection|Midazolam intravenous administration 0.045 mg/kg IV over 40 minutes.
15828035|NCT04220112|Procedure|Real-Time Functional Magnetic Resonance Imaging (RT-fMRI)|RT-fMRI neurofeedback targeting down-regulation of the amygdala
15828036|NCT04220112|Procedure|Sham Procedure|RT-fMRI with feedback non-contingently tied to their activation patterns (activation patterns from a prior participant)
15828037|NCT04220099|Procedure|Electroconvulsive therapy(ECT)|Patients recieve 8-sessions ECT treatments and those kinds of drugs they take since they were recruited remain unchanged during this study.
15828038|NCT04220086|Procedure|Pediatric massage therapy|Children with ASD will receive pediatric massage therapy twice a week for 12 consecutive weeks by professional pediatric massage doctor. In addition, they will receive parent provided pediatric massage therapy at home after their parents received the professional pediatric massage therapy training. The frequency of pediatric massage will not be more than once every day and each session last about 30 minutes.
15828039|NCT04220086|Procedure|Usual care|Including Applied Behavior Analysis (ABA), Educational intervention, Interpersonal development intervention.
15828040|NCT04220086|Other|No intervention|No intervention for healthy controls
15828041|NCT04220073|Biological|JS005 (recombinant humanized monoclonal antibody against IL-17A)|JS005
15828042|NCT04220073|Drug|placebo|placebo
15828043|NCT04220047|Procedure|Left Atrial Appendage Resection and Marshall Ligament Amputation|Left Atrial Appendage Resection and Marshall Ligament Amputation during the cardiac surgery
15828044|NCT04220034|Biological|Blood sample|Blood sample will be collected to determine development or increase level frequencies of different types of autoantibodies in patients receiving ICI for the first time
15828045|NCT04220021|Drug|Metformin|Metformin is a widely used, well-tolerated drug that has been used for decades as a first-line defense for treating type 2 diabetes. Its safety has been well established. Subjects will begin treatment with Metformin at a dosage of 500mg with an escalation of dosage by 500mg every week to a maximal dosage of 2000mg. Dosing will be twice daily.
15828046|NCT04220008|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic HSCT
15828047|NCT04220008|Drug|Busulfan|Given IV
15828048|NCT04220008|Drug|Clofarabine|Given IV
15828049|NCT04220008|Drug|Cyclophosphamide|Given IV
15828050|NCT04220008|Drug|Gemcitabine|Given IV
15828051|NCT04220008|Drug|Mycophenolate Mofetil|Given IV
15828052|NCT04220008|Biological|Rituximab|Given IV
15828053|NCT04220008|Drug|Tacrolimus|Given IV
15828054|NCT04220008|Drug|Vorinostat|Given PO
15828055|NCT04219995|Drug|methylprednisolone sodium succinate|Methylprednisolone sodium succinate will be re-constituted in simple syrup in a concentration of 80mg/mL and will be administered orally at 20mg/kg (max 1000mg) for days 1, 2, and 3 of the intervention phase of the study.
15828056|NCT04219995|Other|Placebo|The placebo used in this study will be simple syrup.
15828057|NCT04219982|Drug|DPI-386 Nasal Gel|Nasal gel
15828058|NCT04219982|Drug|DPI-386 Placebo Nasal Gel|DPI-386 Placebo Nasal Gel
15828059|NCT04219982|Drug|Transderm Scop®|Transderm Scop®
15828060|NCT04219969|Other|Fludeoxyglucose F-18|Given IV
15828061|NCT04219969|Procedure|Magnetic Resonance Imaging|Undergo PET-MRI
15828062|NCT04219969|Procedure|Positron Emission Tomography|Undergo PET-MRI
15828063|NCT04219956|Other|Polyamine Deficient Diet|Diet low in polyamines: the estimated calculated dose is 20 times lower that in an usual diet
15828064|NCT04219943|Procedure|Surgical Treatment for Impacted Femoral Neck Fracture|Surgical Treatment for Impacted Femoral Neck Fracture
15828065|NCT04219930|Diagnostic Test|Expression of nucleotide protein -3|Expression of nucleotide protein -3 will be measured in serum by ELISA
15828066|NCT04219917|Other|Kinesio Tape|Kinesio Tape will be applied to treat the pain associated with patellar tendonitis, to treat the cause of the pain, and to treat both factors.
15828067|NCT04219904|Other|Fludeoxyglucose F-18|Given IV
15828068|NCT04219904|Drug|Gadobutrol|Given IV
15828069|NCT04219904|Procedure|Magnetic Resonance Imaging|Undergo PET/MRI
15828070|NCT04219904|Procedure|Positron Emission Tomography|Undergo PET/MRI
15828071|NCT04219878|Behavioral|Know@Home|Participants randomly assigned to the Know@Home arm will access the features of Know@Home by downloading the app or accessing the website. The contents were developed to serve as a comprehensive mobile HIV prevention platform for MSM or TGW, with HIV prevention and care information and links to resources. This intervention arm provides an toolkit that allows users to access information about prevention services as their needs change. Participants will have access to Know@Home for the study period. The Know@Home arm will offer participants the opportunity to order free condoms and lubricant as well as an at-home sexually transmitted infection (STI) testing kit.
15828072|NCT04219878|Other|Self-test Kit|All participants will be shipped two at-home HIV self-tests. They will also receive a link to a previously-produced video that fully describes the specimen collection process, pointing out common errors and providing tips for successful collection. Participants will interact with study staff through phone, email, or text. Information to schedule a video HIV testing and counseling session with study staff will be made available to participants in all arms via a website, email, and/or text.
15828073|NCT04219865|Drug|Group 1: Compound Edaravone/Placebo Injection|Compound Edaravone 30mg-600mg (containing edaravone 30 mg and 2-aminoethanesulfonic acid 600 mg) / placebo single intravenous infusion for 30min
15828074|NCT04219865|Drug|Group 2: Compound Edaravone/Placebo Injection|Compound Edaravone 60mg-1200mg (containing edaravone 60 mg and 2-aminoethanesulfonic acid 1200 mg) / placebo single intravenous infusion for 30min
15828075|NCT04219865|Drug|Group 3: Compound Edaravone/Placebo Injection|Compound Edaravone 90mg-1800mg (containing edaravone 90 mg and 2-aminoethanesulfonic acid 1800 mg) / placebo single intravenous infusion for 30min
15828076|NCT04219865|Drug|Group 4: Compound Edaravone/Placebo Injection|Compound Edaravone 120mg-2400mg (containing edaravone 120 mg and 2-aminoethanesulfonic acid 2400 mg) / placebo single intravenous infusion for 30min
15828077|NCT04219865|Drug|Group 5: Compound Edaravone/Placebo Injection|Maximum tolerated dose of drug / placebo for a single intravenous infusion for 30 minutes three times a day at an interval of 8 h until the last dose on the morning of Day 3, after which the sequential test drug 30 mg-600 mg / placebo will be administered daily from Day 3 night Intravenous infusion, 30 minutes at 12-hour intervals until morning on Day 7
15828078|NCT04219852|Other|data collection|data collection
15828079|NCT04219839|Behavioral|SOC + Educational Videos Designed Especially for post-transplant patients|Patient focused videos (3-5 minutes each) with topics that will include: What to Expect After Transplant, What is the Kidney, Understanding your Labs, Transplant Medications, General Medical Care Post-Transplant, When to Call your Coordinator, and Self-Management/Sick Day protocols. Video curriculum will be offered in two ways. First, tablet computers with active links to each video will be available in kidney transplant clinic. At provider/coordinator discretion, study participants may also view videos while waiting for other appointments. In addition, for patients with smartphones who consent to this, a desktop link will be provided to the transplant video curriculum webpage (mobile friendly view).
15828080|NCT04219826|Drug|CK-3773274 (5 - 15 mg)|CK-3773274 tablets administered orally
15828081|NCT04219826|Drug|CK-3773274 (10 - 30 mg)|CK-3773274 tablets administered orally
15828082|NCT04219826|Drug|Placebo for CK-3773274|Placebo administered orally
15828083|NCT04219813|Other|Urinary test|Detection of the presence of gluten immunogenic peptides (GIP) in the urine of NCGS/NCWS patients, evaluated two times per week, for 5 weeks, and in the event of symptoms/signs that the patients attribute to the accidental intake of gluten, within the same 5 weeks.
15828084|NCT04219800|Behavioral|Patient-centered counselling and written material|Patient-centered counselling and written material regarding occupational sedentary behaviour, with telephone follow-ups after 1 and 5 weeks.
15828085|NCT04219800|Behavioral|mHealth|"Activity tracker armband (Garmin Vivofit); warns of prolonged sitting and counts daily steps.
~SMS text messages; reminds of activity breaks.
~Mobile video instruction for standing pause gymnastics."
15828086|NCT04219787|Procedure|Long BPL LRYGB|LRYGB with an 180 cm BPL and an AL of 80 cm.
15828087|NCT04219787|Procedure|Short BPL LRYGB|The second group will receive a standard LRYGB with a 80 cm BPL and a 180 cm long AL.
15828088|NCT04219774|Procedure|Endovascular intervention|Endovascular angioplasty of the occluded carotid using balloon angioplasty and reconstruction with stents: coronary stents distally (Rebel, Boston Scientific; Vision, Abbott Vascular) and carotid stents proximal (Acculink and Xcat, Abbott Vascular) Patients will stay on their aspirin 325 mg and clopidogrel 75 mg
15828089|NCT04219774|Drug|Aspirin and Clopidogrel (maximal medical Therapy)|Best Medical Management: daily dual antiplatelet therapy (aspirin: 325 mg p.o. qd and Clopidogrel: 75 mg p.o. qd), optimization of systolic blood pressure (120 -140 mmHg), and smoking cessation.
15828090|NCT04219748|Behavioral|Case Management|"Participants will receive an intensive Case Management (CM) intervention conducted by a multidisciplinary team (Psychiatry, Social Work, Nursing) during 2 months. The intervention will encompass attending weekly or biweekly appointments with the CM team, the interviews will last approximately 30 minutes.
~This CM intervention will include referral to Hospital Clínic de Barcelona Addiction Outpatient Clinic and a personalised assessment of the medical, psychiatric and social situation of each individual by the CM team. An individualised care plan will be established and periodically reviewed by the multidisciplinary team in response to a better understanding of patient needs or to a change in patient health condition.
~The intervention will offer motivational interviewing psychotherapy to enhance motivation to reduce or to quit alcohol use, in crisis intervention, coordination of care, patient education and self-management support, and assistance to navigate in the healthcare system."
15828091|NCT04219735|Drug|Minocycline|Minocycline 100mg BID
15828092|NCT04219735|Drug|Placebos|Placebo
15828093|NCT04219722|Device|Injection of DESIRIAL®|"DESIRIAL® is a hyaluronic acid injectable gel intended to treat symptoms associated with vulvovaginal atrophy in postmenopausal women by vaginal mucosa rehydration in this study.
~1 mL of DESIRIAL® will be injected in the vestibule and on the posterior and lateral walls of the vagina, 2 to 3 cm after the introitus."
15828094|NCT04219722|Other|Injection of placebo|"Placebo is an isotonic saline solution (0.9% NaCl).
~1 mL of placebo will be injected in the vestibule and on the posterior and lateral walls of the vagina, 2 to 3 cm after the introitus."
15828095|NCT04219709|Other|Very low carbohydrate diet|"All meals will be delivered and participants will consume study foods exclusively. Participants will receive a fiber supplement with each meal as needed to promote digestive health, and a daily multi-vitamin, magnesium and omega-3 supplement to ascertain micronutrient sufficiency. Participants will be weighed at each study visit and the diet plan will be adjusted for satiety and weight-maintenance.
~The diet composition will be as follows: 5% carbohydrate, 75% fat, 20% protein."
15828096|NCT04219709|Other|Standard carbohydrate diet|"All meals will be delivered and participants will consume study foods exclusively. Participants will receive a daily multi-vitamin and omega-3 supplement to ascertain micronutrient sufficiency. Participants will be weighed at each study visit and the diet plan will be adjusted for satiety and weight-maintenance.
~The diet composition will be as follows: 50% carbohydrate, 30% fat, 20% protein."
15828097|NCT04219696|Other|Reactive balance training|A research physiotherapist will oversee reactive balance training (RBT) to ensure consistent RBT delivery across participants. Training strategies will be individualized to each participant, based on their balance impairments and rehabilitation goals. The RBT program includes multi-directional 'internal' and 'external' balance perturbations. Internal perturbations are achieved by asking the participant to complete tasks that challenge balance control, such that they lose balance when attempting to perform the task (e.g., kicking a soccer ball). External perturbation are delivered manually using a push or pull from the physiotherapist. As participants improve their reactive balance control, difficulty will be increased by shifting task requirements along a continuum from stable to mobile, and from predictable to unpredictable, and by increasing perturbation magnitude or imposing sensory or environmental challenges.
15828098|NCT04219683|Procedure|Mandibular vertical height augmentation in segmental defects using combined vascularized and non-vascularized fibula flap|Using Free Fibula Flap for reconstruction of mandibular segemental defect
15828099|NCT04219670|Diagnostic Test|MC10 BioStampRC|Utilizing wireless wearable sensors, MC10 BiostampRC, to capture quantitative biometric and movement-based data.
15828100|NCT04219657|Biological|mesenchymal stem cell application|
15828101|NCT04219644|Device|Breatheasy device|
15828102|NCT04219631|Device|expiration mouthpiece used during breathing exercises to ensure a constant ventilatory flowrate.|women enrolled in WINNER-FLOW-URO-MG group will freely use the expiratory mouthpiece device during all their childbirth process.
15828103|NCT04219618|Device|Off-Pump|After a standard median sternotomy, pericardium will be divided to expose the heart and major vessels, and the aortic cannulation sutures will be placed. Pyramid positioner will be applied to the apex of the heart, and the heart will be manually elevated upward. The inflow cannula placement location and placement of the sewing ring will be done with pledged sutures. The LV diaphragmatic site coring will be completed, and immediate LV digital exploration will be accomplished. The LVAD inflow cannula will be inserted through the sewing ring into the LV cavity. Upon completing proper LVAD inflow cannula placement into the LV and securing it in position, the heart will be dropped into the pericardial cavity with the outflow graft elevated for LVAD and outflow graft de-airing and to prevent potential later air embolization. A partial occlusion clamp will be placed on the ascending aorta and appropriately trimmed outflow graft will be sewn to the aorta.
15828104|NCT04219618|Device|On-Pump|A standard median sternotomy incision will be performed and pericardium divided to expose the heart and major vessels. Cannulation will be done through the aorta and the right atrium and the patient will be put on cardiopulmonary bypass (CPB). The patient's heart will be freed from the surrounding tissues. With a cylindrical blade, the surgeon will excise a core of myocardium from the apex. The LVAD sewing ring will then be sutured to the margins of the apical hole. The LVAD will be inserted into the LV cavity through the sewing ring. The outflow graft will be measured for the anastomosis into the aortic root. Partial occlusion clamp will be placed on the aortic root and the anastomosis will be performed. De-airing will be performed and the LVAD will be started. The patient will then be weaned from CPB and decannulated.
15828105|NCT04219592|Diagnostic Test|IgG4 measurement (non-interventional, just obtaining data from medical records)|IgG4 measurement in mg/dL
15828106|NCT04219579|Drug|Antithrombin III, continuous infusion|Antithrombin-III is administered continuously
15828107|NCT04219579|Drug|Antithrombin III, Intermittent infusion|Antithrombin-III is administered intermittently
15828108|NCT04219566|Device|VeNS|Non-invasive electrical vestibular nerve stimulation
15828109|NCT04219566|Device|Placebo device|Sham non-invasive electrical vestibular nerve stimulation
15828110|NCT04219553|Behavioral|Antimicrobial stewardship|The multifaceted AMS intervention includes pharmacist education, a clinical decision support tool, a parent/guardian questionnaire, and individualized monthly audit and feedback with each pharmacist.
15828111|NCT04219553|Other|Comparator (no intervention)|No active intervention
15828112|NCT04219540|Drug|XR-B (SUBLOCADETM)|XR-B (SUBLOCADETM) contains buprenorphine, a partial opioid agonist, and is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days. Following induction and dose adjustment with sublingual buprenorphine, the recommended starting dose is 300 mg monthly for the first two months followed by a maintenance dose of 100 mg monthly thereafter. XR-B is administered monthly only by subcutaneous injection in the abdominal region. Study clinical staff will have flexibility to continue the 300mg dose for greater than 2 months, or use the 100mg dose for initial induction, if the participant's opioid use history or clinical status at the time of dosing support these decisions.
15828113|NCT04219540|Drug|XR-NTX|XR-NTX (Vivitrol®) produces a 30-day mu opioid receptor antagonist blockade Induction procedures require detoxification off opioids (5-7 days since last opioid use), a negative opioid urine toxicology, negative self-report of any recent opioid use, and a naloxone challenge. The naloxone challenge consists of 0.4-0.8mg of IV/SC/IM naloxone followed by the observation of no opioid withdrawal symptoms, or the use of oral naltrexone (12.5-25mg) followed by 1-2 hours of observation. XR-NTX is then delivered as a 380mg (4cc) intramuscular injection to the upper outer gluteus (buttock). Study interventions are FDA-approved, used in accordance with FDA-labeling and will be administered by a study clinician
15828114|NCT04219527|Procedure|Dual-target injection|"Intervention procedure: corticosteroid injection into the subacromial bursa and biceps tendon
~Device for guidance: high-resolution ultrasound Drug: 40 mg triamcinolone acetonide (a kind of corticosteroid) + 3 mL of lidocaine (the medication will be mixed with 40 mg triamcinolone acetonide)"
15828115|NCT04219501|Other|VIVO|Non-invasive mapping system software product that combines patient-specific images (MRI or CT) of the torso and cardiac structures and a 3D image of the torso that identifies precise ECG lead placement to generate a 3D model of the patient's heart.
15828116|NCT04219488|Other|Radial nerve mobilization|
15828117|NCT04219488|Other|Supervised home program|
15828118|NCT04219462|Device|active extracorporeal shock wave|Ultrasound gel was used as a coupling agent, and the applicator of extracorpral shock wave therapy (ESWT) will be held perpendicular to the treatment surface throughout the treatment. Men in this group (n= 20) men receive ESWT twice weekly for 3 consecutive weeks and repeated after a 3-week rest period, for a total of 12 treatment sessions. The patients will receive ESWT for 15 minutes at an energy level of 0.09 and a frequency of 120 shocks/min (1800 pulses per session). Shockwaves were delivered to the distal, mid, and proximal penile shaft, as well as to the left and right crura + 5 mg sildnafil once daily for 3 months
15828124|NCT04219423|Behavioral|Multimodal physical therapy|see description in arm/group description
15828125|NCT04219410|Procedure|Fully minimally invasive esophagectomy|Esophagectomy using a novel fully minimally invasive approach
15828126|NCT04219397|Other|Medication take back|Patients will be provided with formal education about medication take back programs for left-over prescription medications. They will be provided with directions to the closest medication take back facility to their home, and directions to the closet medication take back facility near their post-operative clinic site, and instructed to dispose of any left-over oxycodone medication (at completion of analgesic therapy) through participating in medication take back.
15828127|NCT04219397|Other|Medication home disposal|Patients and their families will be provided with formal education about how to use the medication home disposal kit: Dispose Rx, provided with a Dispose Rx home disposal kit, and instructed to dispose of any left-over oxycodone prescription medications with this kit following completion of analgesic therapy.
15828128|NCT04219371|Diagnostic Test|Quantra System|Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
15828129|NCT04219358|Drug|Vehicle Gel Base|"Apply 0.5ml of gel stored in a 1ml syringe over the lip 3 times a week (Mondays, Wednesdays and Fridays) at night for a period of 4 weeks.
~Gel components: medium molecular weight chitosan, lactic acid 85% and water."
15828130|NCT04219358|Drug|Imiquimod 5% gel|"Apply 0.5ml of gel stored in a 1ml syringe over the lip 3 times a week (Mondays, Wednesdays and Fridays) at night for a period of 4 weeks.
~Gel components: medium molecular weight chitosan, lactic acid 85% and free form imiquimod 5%."
15828131|NCT04219358|Drug|Imiquimod 0,05% gel|"Apply 0.5ml of gel stored in a 1ml syringe over the lip 3 times a week (Mondays, Wednesdays and Fridays) at night for a period of 4 weeks.
~Gel components: medium molecular weight chitosan, lactic acid 85% and imiquimod 0.05% free form."
15828132|NCT04219358|Drug|Imiquimod nanoencapsulated 0,05% gel|"Apply 0.5ml of gel stored in a 1ml syringe over the lip 3 times a week (Mondays, Wednesdays and Fridays) at night for a period of 4 weeks.
~Gel components: medium molecular weight chitosan, lactic acid 85% and imiquomod in a nanoencapsulated suspension at concentration of 0,05%"
15828133|NCT04219358|Drug|Lip sunscreen 30 Sun Protector Factor (SPF)|Apply sunscreen on the lip 30 minutes every day before sun exposure. Protects against both UVA (ultraviolet A) and UVB (ultraviolet B rays).
15828134|NCT04219358|Drug|Dexpanthenol|"Apply dexpanthenol on the lip, two (2) times a day, once in the morning and once in the afternoon.
~Reduces transepidermic water loss and maintaining the natural smoothness and elasticity of the skin. It accelerates the cell renewal, rebuilds damaged tissues and promote the normal keratinisation of the skin and hair."
15828135|NCT04219345|Device|Transcranial direct current stimulation|Both groups will undergo the same protocol of twelve sessions of twenty minutes of tDCS associated with mindfulness, where only the type of received electric current is varied (active or simulated sham type). The twelve sessions will be performed in three sessions per week for four weeks, and mindfulness practice at home will be encouraged on days when the intervention is not administered.
15828136|NCT04219332|Drug|Subserosa injection of indocyanine green|After preoperative exploration, the indocyanine green powder (Dandong Yichuang Pharmaceutical Co) is dissolved in 0.5 mg/ml of sterile water and the prepared solution (1.5 ml for each point) is injected along the subserosal of the stomach at 6 specific points along the lesser and greater curvature of the stomach.
15828137|NCT04219332|Drug|submucosal injection of indocyanine green|One day before surgery, 1.25 mg/ml indocyanine green (Dandong Yichuang Pharmaceutical Co) was prepared in sterile water and 0.5 ml of the solution was injected into the submucosal layer at 4 quadrants around the primary tumor, amounting to 2.5 mg of indocyanine green.
15828138|NCT04219319|Drug|Efficacy of LCAR-T2C CAR-T cells|CD4-directed CAR-T cells administered with lymphodepletion, and to obtain the preliminary efficacy results in subjects who have been diagnosed with relapsed or refractory CD4 positive T lymphocyte tumor
15828139|NCT04219306|Other|Alert on dispatchers screen 'Suspect cardiac arrest'|Alert on dispatchers screen 'Suspect cardiac arrest'
15828140|NCT04219293|Device|Microneedling w/ and w/o PRP|i. Split face comparison. Vertical line drawn midline nose extending upwards to hairline and downwards to jawline separating face into two equal treatment areas. The patients determined side of face will be treated with SkinPen Microneedling and PRP the other (nondetermined from randomization) will be treated with SkinPen Microneedling and glide. The patient side of face that will not use PRP will be treated first. The following settings will be used as treatment protocol. Topical anesthetic Benzocaine 20%, Lidocaine 10%, and Tetracaine 10% will be applied covering entire treatment area. The anesthetic will remain on skin for 30 minutes.
15828141|NCT04219280|Drug|Quillivant XR|Long-lasting liquid solution of Quillivant XR.
15828142|NCT04219280|Drug|Placebos|Liquid solution to mimic the color and taste of Quillivant XR.
15828143|NCT04219267|Behavioral|character strengths-based intervention|"Character strengths-based intervention (CSI) is one kind of positive psychology interventions. It specifically focuses on character strengths, related activities and exercises assisting individuals to reconnect with their characters and promote self-conceptualization.
~The researcher will develop an education module on CSI based on the previous literatures conducted in China and other countries. Before the RCT, this module will be adapted to Chinese participants. During the intervention, participants in the intervention group will be offered the educational module to learn about strengths, comments around the definition of character strengths and examples of specific strengths."
15828144|NCT04219267|Behavioral|early memories|In early memories, participants will be instructed to write down something from their early memories every day. The memories could be the things happened several days or many years before the writing day. The memories could be participant' travel experiences or food for a day. There are no strict restrictions on the timing or content of these early events.
15828145|NCT04219254|Drug|Pembrolizumab 25 MG/ML(MK-3475)|Pembrolizumab 200mg administrated IV every third week as a fixed dose will be used in Phase I and IIa
15828146|NCT04219241|Biological|Cellavita-HD|The participants will receive a total of 12 intravenous administrations of 2x10^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 180 days (total of 4 cycles).
15828147|NCT04219228|Diagnostic Test|Ophthalmic examinations|Ophthalmic examinations include visual acuity, cover test and ocular dominance, noncycloplegic autorefraction, cycloplegia, ocular biometric measurements, cycloplegic auto-refraction, subjective refraction, and anterior and posterior segment examination.
15828148|NCT04219228|Device|Wearable devices|Physical activity, light intensity, and visual information will be measured with wearable devices.
15828149|NCT04219215|Device|hyperbaric oxygen chamber|Application of 100% O2 in an hyperbaric oxygen chamber
15828150|NCT04219215|Device|hyperbaric oxygen chamber|Application of ambient air (21% O2) in an hyperbaric oxygen chamber
15828151|NCT04219202|Radiation|Proton radiation|Therapeutic radiation Treatment with Protons
15828152|NCT04219202|Radiation|Carbon Ion radiation|Therapeutic radiation Treatment with Carbon Ions
15828153|NCT04219189|Other|Vaping condition|Participants will be asked to use a JUUL device to vape 20 puffs over 20 minutes. Participants will use JUUL pods with ~5% nicotine by weight. The anticipated amount of nicotine that will be absorbed with 20 puffs is approximately 1.6 mg, which is equal to approximately 1.5 cigarettes.
15828154|NCT04219189|Other|Control condition|Participants will have access to an uncharged JUUL device with an empty pod for 20 minutes.
15828155|NCT04219176|Diagnostic Test|Spectral optical coherence tomography|Swept-source optical coherence tomography (SS-OCT) is the latest milestone in retinal and choroidal imaging. Because its wavelength of 1050 nm, which is superior to the 840 nm of spectral domain optical coherence tomography (SD-OCT), it is able to overcome ocular opacities such as cataracts and vitritis, wich allows retinal and choroidal visualization of eyes whose fundus is not clearly visible. Consequently , SS-OCT allows visualization of the retinal and choroidal vascular networks, even in eyes with medium opacity
15828156|NCT04219163|Biological|CLL-1.CAR T cells|"Dose escalation study with 3 dose levels:
~DL1: 1x 10^7 cells/m^2, DL2: 3x10^7 cells/m^2, DL3: 1x 10^8 cells/m^2
~If excessive dose limiting toxicity attributed to the product occurs at dose level one, we will request permission from FDA to treat at dose level -1: 5×106 cells/m2"
15828157|NCT04219150|Device|Electrical cardiometry|Four sensors of EC will be applied : first approximately 5 cm above the base of the neck, second on the base of neck, third on the lower thorax at the level of the xiphoid and the fourth one on the lower thorax approximately 5 cm below the 3rd electrode at the level of anterior axillary line. The EC monitor (Electrical Cardiometry monitor, ICON Cardiotronics, Inc., La Jolla, CA 92307; Osyka Medical GmbH, Berlin, and Germany, model C3, serial number 1725303) will be connected to the sensor cable and the patient data will be fed. Corrected flow time (FTC) and stroke volume (SV) will be measured continuously in less than 30 seconds after placing the sensors and inputting the height and weight.
15828158|NCT04219150|Drug|"Fluid and Catheter Treatment Trial FACTT Lite"|The FACTT Lite provided three possible instructions determined by the CVP and urine output: furosemide administration, fluid bolus, or no intervention. FACTT Lite contained instructions to withhold furosemide until the patient achieved a mean arterial pressure greater than 60 mmHg off of vasopressors for at least 12 h.
15828159|NCT04219137|Genetic|Molecular Profiling|This is a correlative study collecting biosamples to evaluate genomic characteristics and treatment outcomes of gastroesophageal adenocarcinoma.
15828160|NCT04219124|Drug|IMP oral tablet|Dapagliflozin 10 MG
15828161|NCT04219124|Drug|Placebo oral tablet|Matching placebo tablets
15828162|NCT04219111|Genetic|Clariom|Clariom S Assay
15828163|NCT04219098|Procedure|Butterfly IQ|10ml of solution with .5cc (or one drop) sterile methylene blue will be injected intra-articularly under ultrasound guidance after a sterile prep. The remaining 20ml will be injected into the periarticular tissues after prosthesis implantation before closure.
15828164|NCT04219098|Other|Standard of Care|The entire volume will be injected into the periarticular tissues after prosthesis implantation before closure.
15828165|NCT04219085|Device|Continuous Glucose Monitor|Wearing of a continuous glucose monitor to monitor blood glucose levels in women with gestational diabetes
15828166|NCT04219085|Other|Routine Care|Use of a glucometer to monitor blood glucose levels in women with gestational diabetes
15828167|NCT04219046|Drug|Naloxégol oxalate|Oral administration once daily
15828168|NCT04219046|Drug|Placebo oral tablet|Oral administration once daily
15828169|NCT04219033|Other|EEG(Electroencephalogram) change|patients are found to have characteristic EEG change
15828170|NCT04219020|Other|Co-created intervention|
15828171|NCT04219007|Drug|Vosoritide|After enrollment, subjects will be followed for a 6 month observation only period to establish a baseline height velocity as well as safety profile and quality of life assessment. Vosoritide will then be administered daily via subcutaneous injection at a dose of 15 µg/kg/day for 12 months.
15828172|NCT04218994|Other|Flossing technique|Subjects instructed on flossing technique
15828173|NCT04218981|Drug|Antipsychotic drugs|Choose one of these antipsychotics (olanzapine, risperidone; amisulpride) for schizophrenia group
15828174|NCT04218981|Drug|Mood stabilizer|Choose lithium or valproate for bipolar disorder group
15828175|NCT04218981|Drug|Paroxetine|Patients with major depressive disorder are treated with paroxetine
15828176|NCT04218968|Drug|Carvedilol|Primary procedures in this study are MIBG scan, DAT scan, NM-MRI, and carvedilol titration. Subjects will return for research visits and imaging every six months for three years. The investigators hypothesize that the rate of decline in DAT scan123I-Ioflupane uptake will be slower in subjects who have received the adrenergic blocker carvedilol, resulting in a decreased clinical phenoconversion rate to parkinsonism.
15828177|NCT04218955|Combination Product|Silver Diamine Flouride|Material used to arrest caries in children
15828178|NCT04218942|Device|Exime is the name of the single use temporary prostatic stent used instead of the Foley catheter|"Insertion after instillation of a local lubricant anesthetic gel in the urethra like for Foley insertion. Calibration of the urethral meatus with a 22F Bougie. Insertion of the Bougie until abutment against the posterior wall of the bulbous urethra just below the striated sphincter. Note depth of abutment on the scale of the Bougie. Retrieve the Bougie and glide the device to the same depth until abutment against the posterior wall of the bulbous urethra. At this stage the stent is correctly positioned. Stent release: unlock the Luer connection between pusher tube and stylet . Retrieve pusher tube, stylet and flattener tube.
~Control of correct positioning: ask patient to stand up to verify the absence of any urine leak. Ask patient to void immediately to control clear urine output."
15828179|NCT04218929|Other|Study Formula (SF)|New infant formula for term infants fed ad lib
15828180|NCT04218929|Other|Comparator Formula (CF)|Commercially available infant formula for term infants fed ad lib
15828181|NCT04218916|Drug|Rhodiola Rosea Capsules|0.28g per capsule, 0.56g once (2 capsules), three times a day
15828182|NCT04218916|Drug|Placebo|2 placebo capsules once, three times a day
15828183|NCT04218903|Behavioral|Combined training performed four times per week (CT4)|CT4 will perform four combined training sessions per week throughout 12 weeks. Each session will be composed 10-15 minutes of resistance exercise (1-4 sets of 10-15 repetitions, using an intensity corresponding to 50-70%1RM in 3 exercises) followed by 20-25 minutes of aerobic exercise (walking or running at an intensity corresponding to 60-70% of VO2peak).
15828184|NCT04218903|Behavioral|Combined training performed two times per week (CT2)|CT2 will perform two combined training sessions per week throughout 12 weeks. Each session will be composed 20-30 minutes of resistance exercise (1-4 sets of 10-15 repetitions, using an intensity corresponding to 50-70%1RM in 6 exercises) followed by 40-50 minutes of aerobic exercise (walking or running at an intensity corresponding to 60-70% of VO2peak).
15828185|NCT04218890|Diagnostic Test|Urinary tissue factor (TF), tissue factor pathway inhibitor (TFPI) and plasmin|urinary sample
15828186|NCT04218864|Behavioral|Strength for U in Relationship Empowerment (SURE)|A brief computer-based intervention (one session plus one booster session) based on motivational interviewing.
15828187|NCT04218864|Behavioral|Attention, time, and information matched control|A brief computer based intervention (one session plus booster session) that involves viewing of popular television shows
15828188|NCT04218851|Drug|Posaconazole IV|Posaconazole (POS) 6 mg/kg body weight by IV infusion
15828189|NCT04218851|Drug|Posaconazole PFS|POS PFS 6 mg/kg body weight taken orally
15828190|NCT04218851|Drug|Posaconazole tablet|POS tablet 300 mg taken orally
15828191|NCT04218838|Device|CornerLoc SI Joint Stabilization Procedure|CornerLoc minimally invasive SI Joint Stabilization System
15828192|NCT04218838|Drug|Intra-articular Sacroiliac Joint Steroid Injection|Standard of Care - Steroid injection into the sacroiliac joint
15828193|NCT04218825|Drug|chlormethine gel|Gel to be applied to all skin areas affected by MF-CTCL
15828194|NCT04218812|Diagnostic Test|No electrical source imaging (ESI)|For all patients: MRI, semiology, visual interpretation of EEG, and in selected cases, PET, SPECT
15828195|NCT04218812|Diagnostic Test|Automated electrical source imaging (ESI)|"The automated source imaging consists of 2 phases
~Automated detection of EDs
~Source imaging of each spike cluster and seizure onset epoch."
15828196|NCT04218799|Drug|Intranasal Mupirocin and Topical Chlorhexidine|Antimicrobial antiseptic skin cleanser (4% chlorhexidine) for daily use on Day 1, 3 and 5 of Week 8 of the study. BACTROBAN NASAL ointment (mupirocin calcium ointment, 2%) for use intranasally twice-daily on Day 1, 2, 3, 4 and 5 of Week 8 of the study.
15828197|NCT04218786|Drug|Colchicine|The tablet will be given once daily for the span of the study
15828198|NCT04218786|Drug|Placebo oral tablet|The tablet will be given once daily for the span of the study
15828199|NCT04218773|Drug|Phenylephrine|Patients will receive intravenous phenylephrine at a rate of 60 µg/min. The infusion rate will be adjusted at 30 µg/min increments (maximum 180 µg/min) at 3-minute intervals to maintain an increase in SBP to the target SBP of 160 - 220 mmHg or a 20% increase above baseline SBP values.
15828200|NCT04218773|Drug|Norepinephrine|As an alternative to intravenous phenylephrine, intravenous norepinephrine can be used with an initial infusion rate of 3 mcg/min. The initial infusion rate of norepinephrine will be adjusted at 1 mcg/min increments at 3-minute intervals to achieve and maintain the target blood pressure. Maximum dose is 25 mcg/min. Combination therapy with both agents (phenylephrine and norepinephrine) to achieve and maintain blood pressure targets is not permitted.
15828201|NCT04218760|Drug|Isosorbide Mononitrate 60 MG Extended Release Oral Tablet [Imdur]|1 tablet Isosorbide Mononitrate 60 mg administrated orally.
15828202|NCT04218760|Other|Blood sample|3 blood samples from a periferal vein, two for RNA and one for metabolomics are taken right before administration of isosorbide mononitrate, 3 hours after administration of isosorbide mononitrate and again 5 hours after administration of isosorbide mononitrate.
15828203|NCT04218747|Behavioral|VA 365 Demonstration Benefits|Reducing hunger 365 days a year in households with school children by transforming schools into food hubs ( free breakfast, lunch, supper, and food backpacks for the weekend) and providing nutrition education to parents.
15828204|NCT04218734|Drug|DBPR108|DBPR108: 100 mg, once daily for 24 weeks.
15828205|NCT04218734|Drug|metformin hydrochloride|metformin hydrochloride: 500 mg, 1-3 times daily for 24 weeks.
15828206|NCT04218734|Drug|placepo|placebo:100 mg, once daily for 24 weeks.
15828207|NCT04218721|Other|InvolveMe|An eHealth application that allows participants to report symptoms and needs prior to out-patient visits at the hospital. The application creates a summary that allows patients to prioritize what is important to talk with their health care providers about. Health care providers can use the summary to prepare the consultation.
15828208|NCT04218708|Drug|Nicotine patch and gum|Nicotine patch and gum will be given to subjects in the Nicotine replacement therapy cohort every visit after providing exhaled CO/Saliva cotinine test.
15828209|NCT04218708|Behavioral|Minnesota Nicotine Withdrawal Scale (MNWS)|The MNWS assesses symptoms associated with nicotine withdrawal (i.e., craving, irritability, anxiety, difficulty concentrating, restlessness, increased appetite or weight gain, depression, and insomnia).
15828210|NCT04218708|Behavioral|ASSIST (the Alcohol, Smoking and Substance Involvement Screening)|The ASSIST is the Alcohol, Smoking and Substance Involvement Screening Test. It is a brief screening questionnaire to find out about people's use of psychoactive substances (alcohol, smoking and substance involvement).
15828211|NCT04218708|Behavioral|Counseling|At each study visit, participants will receive counseling protocol that will be based on effective counseling manuals. The PI will train the research assistant who will assist the PI in tailoring the manual to the target group: counseling will cover health education, social support issues, and motivational enhancement to improve self-efficacy while addressing other aspects known to contribute to smoking among PLWHA (e.g., tips on dealing with depression and feeling stigmatized particularly in relation to HIV).
15828212|NCT04218708|Device|NIDA Standardized Research E-cigarettes (SREC)|"NIDA SREC has a case with a liquid tank. The e-liquid is supplied in sealed disposable cartridges that deliver >300 puffs / cartridge. The SREC uses a battery recharged via a micro USB port. A single charge is designed to outlast the capacity of an e-liquid cartridge. The e-liquid is tobacco flavored and contains nicotine."
15828213|NCT04218695|Drug|Ceftriaxone|Antibiotic
15828214|NCT04218695|Drug|Normal saline|50cc intravenous once daily
15828215|NCT04218682|Behavioral|Shadow's Edge Mobile Application Gameplay|6 weeks of individual, interactive game play of the Shadow's Edge mobile app.
15828216|NCT04218669|Procedure|Roux-en-Y Hepaticojejunostomy|The common hepatic duct was cut and the duodenal side is closed by suture. The small intestine was cut off 15 cm below the ligament of Treitz. The distal end was lifted, and a 1-2 cm incision was made at the jejunal wall 4-5 cm from the jejunal stump. The anastomosis is used a 5-0 PSD Ⅱ suture, with double needles, inside-out in the jejunum and outside-in in the hepatic duct. One side of needles was used to continuely penetrate and suture the whole layer of the posterior-lateral wall of the jejunum, the posterior-lateral wall of the biliary duct, and the other side of needles was used to continuely stuere the anterior part of the anastomosis. Mucosa-to-mucosa contact should be ensured with every stitch.The anastomotic stomas were then checked for leakage. Enteric-enteric anastomosis was performed 60 cm below the site of the hepatojejunal anastomosis.
15828217|NCT04218669|Procedure|T-tube drainage|The T-tube was placed for biliary drainage and the common bile duct was intermittently sutured with 4-0 vicryl sutures.
15828218|NCT04218656|Drug|Rivaroxaban 2.5 Mg Oral Tablet|2.5 mg rivaroxaban twice a day in addition to Aspirin 100mg once a day (standard care).
15828219|NCT04218643|Other|Ultrasound-guided technique|IV inserted via ultrasound guidance
15828220|NCT04218643|Other|Standard technique|IV inserted via standard technique
15828221|NCT04218630|Other|Reformer pilates exercises|The program consisted of 10 minutes warm-up exercises, reformer pilates exercises for 40 minutes and 10 minutes cool-down exercises. The exercises were started with 6-8 repetitions, increased to 1-2 repetitions each week and applied to be 12-15 repetitions in the last week. Increasing the resistance of the springs and adding different positions were used for progression of exercises.
15828222|NCT04218630|Other|Home mat pilates exercises|The program consisted of 10 minutes warm-up exercises, clinical pilates-based exercises on mat for 40 minutes and 10 minutes cool-down exercises. The exercises were started with 6-8 repetitions, increased to 1-2 repetitions each week, and applied to be 12-15 repetitions in the last week.
15828223|NCT04218617|Device|Diagnostic MRI|Diagnostic MRI
15828224|NCT04218617|Device|Planning MRI|Planning MRI: high definition (HD) MRI of the region of interest (1 vertebral level above and below the level(s) being treated)
15828225|NCT04218617|Other|Simulation CT|Simulation CT is obtained (1.5 mm slice thickness)
15828226|NCT04218617|Other|QOL assessment|QOL assessment
15828227|NCT04218617|Other|Brief pain inventory (BPI)|Brief pain inventory (BPI), including narcotic assessment
15828228|NCT04218617|Radiation|sSRS in 1 fraction|sSRS 18 Gy in 1 fraction
15828229|NCT04218617|Radiation|sSRS in 2 fraction|sSRS 24 Gy in 2 fractions to be delivered either on consecutive days or one day apart.
15828230|NCT04218604|Procedure|Personalized atrial fibrillation ablation|Atrial fibrillation (AF) ablation adapting the ablation index (AI) target in a point-by-point manner, according the local left atrial wall thickness (LAWT), as measured by multidetector cardiac tomography (MDCT)
15828231|NCT04218591|Other|PRP|Platelet rich plasma
15828232|NCT04218591|Other|Placebo|Saline
15828233|NCT04218578|Diagnostic Test|speckle tracking analysis of transthoracic echocardiogram|analysis at workstation with 2D strain-Speckle tracking echocardiography of transthoracic cardiac echo at baseline and one-year follow up examination
15828234|NCT04218565|Biological|Golimumab (GOL)|Patients with refractory BD associated uveitis will receive Golimumab therapy, the efficacy and corticosteroids-sparing effects will be evaluated.
15828235|NCT04218552|Drug|AD209|PO, Once daily(QD), 8weeks
15828236|NCT04218552|Drug|Amlodipine low|PO, Once daily(QD), 8weeks
15828237|NCT04218552|Drug|Amlodipine high|PO, Once daily(QD), 8weeks
15828238|NCT04218552|Drug|Telmisartan|PO, Once daily(QD), 8weeks
15828241|NCT04218526|Device|Vercise DBS System|Vercise Deep Brain Stimulation (DBS) System that consists of two bilateral directional DBS Cartesia electrodes implanted in the cuneiform nucleus and a Gevia generator implanted in the upper chest area just below the clavicle.
15828242|NCT04218513|Drug|Compound Edaravone Injection|30 min intravenous infusion
15828243|NCT04218513|Drug|Edaravone Injection|30 min intravenous infusion
15828244|NCT04218513|Drug|2-Aminoethanesulfonic Acid Injection|30 min intravenous infusion
15828245|NCT04218500|Other|Niacinamide 4%|cream moisturizer
15828246|NCT04218500|Other|Virgin Coconut oil 30%|cream moisturizer
15828247|NCT04218487|Drug|Xuefu-Zhuyu Capsule|treatment with 2.4g (6 capsules) of XFZY three times daily for 12 weeks.
15828248|NCT04218487|Drug|placebo|treatment with 2.4g (6 capsules) of placebo three times daily for 12 weeks.
15828249|NCT04218487|Other|conventional therapy|conventional therapy will be given according to the suffering diseases including stable coronary heart disease, chronic insomnia, headache, endometriosis.
15828250|NCT04218474|Procedure|Evaluation Of Cross Mental Nerve Transfer In Restoration Of Chin &Lip Sensation Post Inferior Alveolar Nerve Injury|-sural nerve harvest ,and use it as conduit between injured mental nerve and the normal one
15828251|NCT04218461|Diagnostic Test|PRE-DELIRIC model|To predict delirium according to risk factors in the PRE-DELIRIC model
15828252|NCT04218448|Other|Hypnorelaxation|"Hypno-relaxation is induced by following VAKOG: external sensory identification, fixation of attention, bodily sensation, breathing, sensory perceptions, closing of the eyes.
~The work phase follows induction and allows deepening of the hypnotic trance. It corresponds to a metaphorical narrative associated with post-hypnotic suggestions and is fueled by the construction of adapted suggestions and metaphors, adapted to each patient. The investigator who remains present throughout the duration of the examination, maintains a hypnotic, empathetic, attentive attitude, and makes it possible to recover this material. Using the elements previously supplied by the patient, the investigator tells a story which allows the patient to focus his attention on something other than the performance of the somatosensory evoked potentials examination. The investigator, thanks to hypnosis, allows the development"
15828253|NCT04218435|Drug|Sacubitril / Valsartan Oral Tablet|"Sacubitril/Valsartan is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.
~Sacubitril/Valsartan is usually administered in conjunction with another heart failure therapies, in place of an ACE inhibitor or other ARB."
15828254|NCT04218422|Procedure|Battlefield Acupuncture|Acupuncture at 5 points on the ears
15828255|NCT04218422|Procedure|Sham Acupuncture|Sham acupuncture in 2 points for liver and 1 point for stomach
15828256|NCT04218409|Drug|oxycodone|Oral oxycodone 5 mg orally
15828257|NCT04218409|Drug|oxytocin|intranasal oxytocin administration (48 IU)
15828258|NCT04218409|Other|Placebo oxycodone|oxycodone 0 mg orally
15828259|NCT04218409|Other|Placebo oxytocin|intranasal placebo administration
15828260|NCT04218396|Device|Virtual Reality use during painful bedside procedure|Virtual reality (VR) will be used in addition to standard analgesic practices during painful bedside procedures. A head mounted display (HMD, Oculus Go Model #1KWPH812PN8354) and noise-cancelling headphones (Sony Model #MDRZ110B) will be provided to the patient during the procedure. This unit involves the patient wearing VR goggles, noise-cancelling headphones, and using a smartphone-based program with various applications the patient can choose from for analgesia/relaxation (eg: calming imagery/scenery of nature, activities involving mindfulness, interactive games or guided imagery, music and imagery, exercise imagery...etc). There are numerous, standard applications available for the patient to choose from, and the choice of most optimal application for analgesia, distraction, or anxiolysis will be left to the decision of the patient prior to their procedure.
15828261|NCT04218396|Drug|Standard Treatment during painful bedside procedure|Pharmacologic sedation or high dose opioids (e.g. nurse-administered IV opioids, anxiolytics and sedatives, patient-controlled analgesia, anesthesiologist administered sedation, general anesthesia if required)
15828262|NCT04218383|Device|Transcranial Direct Current Stimulation|Anode placed over the OFC and cathode placed over the right primary motor cortex.
15828263|NCT04218370|Procedure|Dialysis|Dialysis treatment, either in the form of hemodialysis or continuous renal replacement therapy (if patient develops hemodynamic instability)
15828264|NCT04218357|Drug|Probenecid|safety
15828265|NCT04218357|Drug|Matching placebo|Placebo
15828266|NCT04218344|Other|60mls of blood donated for research analysis|All patients presenting with a possible Acute Coronary Syndrome will be invited to donate 60 mls of blood at the time of their angiogram.
15828267|NCT04218331|Behavioral|JASPER|JASPER is a developmentally anchored behavioral intervention that assumes that communication develops from social interactions in which specific social engagement strategies, symbolic representations, and early communication forms are modeled and naturally reinforced by the adult's responses to the child. The adult referred in this condition is the clinician/therapist.
15828268|NCT04218331|Behavioral|PROMPT|PROMPT is a multidimensional oral-motor approach to speech production disorders.
15828269|NCT04218318|Device|phototherapy|Phototherapy will be commenced for neonates in both groups according to AAP guidelines.Neonates will be treated with intensified overhead blue LEDs phototherapy if they have a TSB level at or above phototherapy threshold. Neonates will be started on intensified 360◦ LED phototherapy if they have TSB level within 50µmol/L below the exchange threshold. The administration of IVIG is indicated in infants with isoimmune hemolytic disease if TSB lies within 34 to 51 micromol/L of the threshold for exchange transfusion and not responding to initial intensified phototherapy.Infants with a TSB concentration above the thresholds for exchange should have immediate intensified 360◦ LED phototherapy, and preparation for exchange transfusion will be started.Infants showed clinical signs of acute bilirubin encephalopathy will have an immediate exchange transfusion.
15828270|NCT04218305|Diagnostic Test|Serum Level Of Fetuin A|
15828271|NCT04218292|Device|Micro Plug Set|The Micro Plug Set is indicated for arterial embolization in the peripheral vasculature.
15828272|NCT04218279|Other|Sleep Health Education|Intervention materials include 10 brief education modules that the target population will review/view on a secure study-specific website.
15828273|NCT04218266|Drug|BAY2433334|Tablet, taken orally once a day.
15828274|NCT04218266|Drug|Apixaban|Capsule, taken orally twice a day.
15828275|NCT04218266|Other|BAY2433334 matching placebo|Tablet, taken orally once a day.
15828276|NCT04218266|Other|Apixaban matching placebo|Capsule, taken orally twice a day.
15828277|NCT04218253|Dietary Supplement|300 calories or 500 calories nutrient rich in branched chain amino acids and dietary fiber|300 kcal rich in branched chain amino acids and water soluble dietary fiber (12g) for Mild malnutrition, or 500 kcal rich in branched chain amino acids and water soluble dietary fiber (12g) for moderate to severe malnutrition. The degree of malnutrition is determined by Patient-Generated Subjective Global Assessment (PG-SGA).
15828278|NCT04218253|Behavioral|Dietary mission|Dietary education was conducted according to preoperative nutritional requirements
15828279|NCT04218240|Drug|Pregabalin 200 MG capsules|oral pregabalin 200 mg capsules given with a taper on day 5
15828280|NCT04218240|Drug|Placebo oral tablet|oral Placebo
15828281|NCT04218240|Drug|Lofexidine 0.18Mg Tab|lofexidine 0.18 tab given with a taper starting on day 5
15828282|NCT04218227|Behavioral|Self-hypnosis/self-care group|Self-hypnosis/self-care
15828283|NCT04218227|Behavioral|Music/self-care|Music-therapy/self-care
15828284|NCT04218227|Behavioral|Self-care|Self-care
15828285|NCT04218227|Behavioral|Psycho-education|Psycho-education
15828286|NCT04218227|Behavioral|Self-hypnosis/self-care motivation|Motivation to learn self-hypnosis/self-care
15828287|NCT04218214|Other|LIFE-DM Group (Integrated Depression and Livelihood Group Intervention)|Livelihood Integration for Effective Depression Management (LIFE-DM) program aims to address the dual challenges of poverty and depression by integrating evidence-based treatment for depression management and microfinance services. The LIFE-DM group is a 12-session based on Behavior Activation and Problem Solving therapy for depression applied to both mood problems and livelihood stressors. Livelihood supports includes training on personal finance, referrals to vocational training, and access to microfinance loans. The group is provided at the local commune health stations, and facilitated by primary care health provider and a lay community provider from the Women's Union. The intervention generally lasts about 3-4 months.
15828317|NCT04217967|Drug|Ixazomib|the ixazomib group uses ixazomib as the comparator group, the combination group receives both lenalidomide and ixazomib as the experimental group
15828318|NCT04217967|Drug|Lenalidomide|the lenalidomide group uses lenalidomide as comparitor group and the combination group receives both lenalidomide and ixazomib
15828373|NCT04217460|Behavioral|Intervention for fluency difficulty|Children are required to speak materials they hear on recordings. The materials are not words, but contain sound sequences that occur in their language and English.
15828288|NCT04218201|Behavioral|PCP brief advice|Brief advice will be delivered by the patient participant's PCP as part of the medical visit. Before the encounter with the patient participant, PCPs will receive a brief printed summary report from the RA or clinical staff. The summary advises the PCP that their patient participant screened positive for risky opioid use, lists the patient participant's screening results (TAPS Tool +/- COMM) and gives a suggested counseling script.The counseling script will include specific advice on opioid-related risks, will inform patient participants of resources to help them reduce their risk , and will include a recommendation to reduce their risk behavior.
15828289|NCT04218201|Behavioral|Video doctor|Following the PCP encounter, and before completing the post-visit assessments or leaving the clinic, patient participants will meet with the RA to view a video on tablet or desktop computer that reinforces the PCP's counseling. The video is a recording of a provider delivering brief advice about opioid use that includes the same elements covered in the summary report outlined above, though it will not be tailored to the patient participant's specific screening results. When possible, this video will feature a provider from the same clinic where the patient receives care.
15828290|NCT04218201|Behavioral|Telephone health coaching|All patient participants in the STOP arm will receive telephonic health coaching sessions at approximately 2- and 6-weeks post-baseline. Patient participants who do not improve or who experience clinical worsening of unhealthy opioid use may receive additional coaching sessions (approximately 4 sessions) from the telephone health coach. Coaching is delivered from a centralized call center, by staff that receive standardized training and supervision. To the extent possible, calls will be scheduled at the patient participant's convenience (e.g., evenings, weekends).
15828291|NCT04218201|Behavioral|Nurse Care Manager (NCM) intervention|NCMs will provide health education and counseling on risk reduction, overdose prevention and self-management skills.Patient participants will be asked to participate in a baseline visit with the NCM, which will occur on the same day as the baseline PCP visit if possible. The NCM continues working with patients in the STOP condition throughout their 12 months of study participation. Following the initial visit with the NCM, the frequency of visits depends on patient participant needs.
15828292|NCT04218175|Other|neuromobilization exercises|Median nerve neuromobilization (stretching and shifting) was performed. For median nerve stretching; The subjects were brought to shoulder depression and 90 degrees of abduction while the dominant side forearms were supination. In this position, median nerve stretching was performed by extending the participant's head to the opposite side while flexing the wrist and finger. After waiting for 30 seconds in this position, the wrist and head were moved to the neutral position and the participants relaxed. For median nerve shift; The subjects were brought to shoulder depression and 90 degrees of abduction while the dominant side forearms were supination. In this position, the participant flexed his wrist and fingers while lateral flexion of his head to the opposite side, and flexed his wrist and fingers while lateral flexion of the head to the same side.
15828293|NCT04218162|Drug|Lasmiditan 50mg|Lasmiditan 50mg
15828294|NCT04218162|Drug|Lasmiditan 100mg|Lasmiditan 100mg
15828295|NCT04218162|Drug|Placebo|Placebo
15828296|NCT04218149|Drug|Bupivacaine Injection|Block with bupivacaine
15828297|NCT04218136|Biological|Blood samples|A minimum of 4 blood samples and a maximum of 6 blood samples will be collected. Venous return blood samples collected as part of routine monitoring of patients for bioclinical parameters. Samples will be collected before start of the infusion and end of the infusion
15828298|NCT04218123|Drug|Venlafaxine|Daily oral intake 37.5 mg
15828299|NCT04218123|Drug|Placebo oral tablet|Daily oral intake
15828304|NCT04218097|Other|Study questionnaire|Monitoring - data collection: Sending of an information form and the study questionnaire, the YFAS and Hospital Anxiety and Depression (HAD) scale by post within a follow-up period of 24 to 36 months. With a stamped envelope for the answer and a telephone reminder if necessary.
15828305|NCT04218084|Drug|Voxelotor|Participants are randomized 1:1 to receive voxelotor or placebo.
15828306|NCT04218084|Drug|Placebos|Matching placebo.
15828307|NCT04218071|Drug|Ruxolitinib|Ruxolitinib at protocol-specified doses for given platelet count
15828308|NCT04218071|Drug|9-ING-41|9-
15828309|NCT04218058|Procedure|reduction of zygomatic arch in zygomaticomaxillary complex fracture|ultrasound guided reduction of zygomatic arch
15828310|NCT04218045|Procedure|Laparoscopic single anastomosis sleeve ileal bypass|a simple loop gastro-ileal bypass is added to the sleeve procedure.
15828311|NCT04218045|Procedure|Laparoscopic sleeve gastrectomy|Conventional sleeve gastrectomy using endoscopic stapler
15828312|NCT04218032|Device|sphygmomanometer, SpyghmoCor, CNAP500|blood pressure is measured with developed new non-invasive technology, oscillometry from the fingertip, and compared to non-invasive standard blood pressure measurement using a standard sphygmomanometer/SpyghmoCor device/CNAP500 device.
15828313|NCT04218019|Device|TTFields|The NovoTTF-200 A device used in this trial delivers very low intensity, alternating electric fields to the tumor site through the scalp. These fields are known as Tumor Treating Fields or TTFields.
15828314|NCT04218006|Genetic|Mutation Analysis|Specific members of nuclear and extended family relatives will be contacted to propose genetic counseling. Approvals for genetic testing will be asked and necessary information forms will be provided. A total of 5 ml of blood will be collected from each patient for DNA analysis. Blood samples will be analyzed at the Damagen Genetic Diagnosis Center (Ankara), after which no samples will be stored and all samples will be destroyed.
15828315|NCT04217993|Drug|Jaktinib hydrochloride tablets|Jaktinib hydrochloride tablets 100mg twice dose group，Jaktinib hydrochloride tablets 150mg qd dose group, Jaktinib hydrochloride tablets 200mg qd dose group and Jaktinib hydrochloride tablets 100mg qd dose group
15828316|NCT04217980|Diagnostic Test|Lung ultrasonography (LUS) or Chest X ray (CXR)|pediatrician researcher (PR) will conduct a LUS or CXR at admission time as a first test of lung image depending on randomized group.
15828319|NCT04217954|Drug|OXA, 5-FU and bevacizumab plus Toripalimab|"concomitant treatment: A. HAIC: oxaliplatin (40 mg/m2 for 2 hours), 5-fluorouracil (800 mg/ m2 for 22 hours) on days 1-3, and arterial bevacizumab 300mg for 2 hours on d1 before oxaliplatin through a percutaneously implanted port-catheter system.
~B. Intravenous PD-1 inhibitor (Toripalimab) 240 mg for 30-60 minutes on d1 before the HAIC.
~The concomitant treatment repeat every three week, up to 6 cycles.
~Maintenance treatment: Bevacizumab (300mg) + PD-1 inhibitor (Toripalimab 240mg) will be given intravenously, every 3 weeks."
15828320|NCT04217941|Procedure|Health education with practical demonstration of nasal ointment|Health education with practical demonstration of medicine was compared to health education without practical demonstration
15828321|NCT04217941|Drug|Health Education and practical demonstration of Nasal spray and intranasal ointment|We compared the effect of Health education and practical demonstration for using nasal spray and apply intranasal ointment compared to health education without practical demonstration
15828322|NCT04217928|Procedure|Arthroscopic Debridement|Arthroscopic debridement will be performed under portal site local anaesthesia.
15828323|NCT04217928|Procedure|Arthroscopic Hemi-Trapeziectomy with Mini TightRope|Anaesthesia, position and arthroscopy will be performed in the same way as for arthroscopic debridement, except the distal part of the trapezium will be resected to a depth of 3-4mm together with protruding osteophytes.
15828324|NCT04217902|Other|Description of patients' experiences of diabetes care delivery and planning|Semi-directed interviews will be conducted with people living with type 1 or type 2 diabetes in person or by phone to assess and describe the care delivery pathway they have been through. Information on 3 domains will be assessed: clinical (information they consider essential for health care professionals to systematically have access to during consultations and other health-related interventions such as therapeutic education sessions), technological (what kind of digital services and technologies they use or are willing to use), and behavioural (the decision-making process and the key interactions that build the care delivery pathway).
15828325|NCT04217902|Other|Description of health care professionals needs and experiences in diabetes care delivery and planning|Semi-directed interviews will be conducted with health care professionals working in diabetes care in person or by phone to assess and describe their needs and experiences in diabetes care. Information on 3 domains will be assessed: clinical (the information they consider to be essential to inform decisions in diabetes care, where and if they currently find that information and problems they might encounter), technological (which software they currently use and how data is input into clinical information systems), and behavioural (how care coordination is currently managed, how interactions with patients and other professionals are undertaken).
15828326|NCT04217889|Other|Questionnaire|Short questionnaire that can be completed during the usual consultation.
15828327|NCT04217876|Diagnostic Test|post-processing analysis of cardiac imaging (strain echocardiography)|"A dedicated software package for two-dimensional speckle tracking strain analysis (XStrain™, Esaote, Florence, Italy) was used to quantify both ENDO and EPI strains. Our echocardiographic imaging acquisition protocol for 2DSTE consisted in the acquisition of three consecutive cardiac cycles from non-foreshortened apical views (4, 2, and 3 chambers) obtained during breath hold. Frame-by- frame displacement of ENDO and EPI points was automatically evaluated, generating strain curves for each segment.
~The tracking quality was verified for each segment, and subsequent manual adjustments were performed, when required. All data were analyzed with the aid of Fourier techniques, which ensure greater accuracy using the periodicity of the heart motion."
15828328|NCT04217863|Behavioral|GDP|Guided Disclosure Protocol
15828329|NCT04217850|Other|250 kcal Dietary Energy Restriction|The nutrition intervention will be individualized and implemented as a free-living energy-restricted eating plan where energy intake will be based on a mild restriction (approx. 250 kcal/day).
15828330|NCT04217850|Other|Aerobic Exercise|Supervised aerobic exercise will be combined with the energy restriction. Individuals will perform aerobic exercise (treadmill, cycle, or rower or combination) 4-5 days per week for 12 weeks. At each session they will expend 250 or more calories to further meet or exceed the 500 kcal energy deficit.
15828331|NCT04217837|Device|Transcranial Magnetic Stimulator|Transcranial magnetic stimulation (TMS) uses a targeted pulsed magnetic field, similar to what is used in an MRI (magnetic resonance imaging) machine. While the patient is awake and alert, NeuroStar TMS Therapy stimulates areas of the brain that are underactive in depression.
15828332|NCT04217824|Procedure|pilonidal sinus excision|Closure of the defect in pilonidal sinus excision with one of the randomly selected flap methods.
15828333|NCT04217811|Other|No intervention|No intervention
15828334|NCT04217798|Drug|Niraparib|Subjects will receive niraparib combined with oral etoposide (on day 1-20, every 30 days). After 6-8 cycles, oral etoposide will be terminated. Niraparib will be still given to subjects until disease progression, intolerable toxicity or withdrawal of informed consent.
15828335|NCT04217785|Drug|Optive, Ophthalmic Solution|6 drops per day, for 8 weeks
15828336|NCT04217785|Biological|Umbilical Cord Serum eye drops|UCS eye drops (6 drops per day, for 8 weeks)
15828337|NCT04217785|Drug|Genteal lubricant gel|Genteal lubricant gel (2 drops per day, for 8 weeks)
15828338|NCT04217772|Device|Optical Coherence Tomography Angiography|A device testing the vascular density in the retina
15828339|NCT04217759|Behavioral|Healthy lifestyle intervention|"The main goal was to provide knowledge and skills for targeted population in order for them to adapt healthy lifestyle throughout their life. At the end of intervention, participants were expected to be fully equipped with necessary knowledge and fundamental skills in adapting and maintaining healthy lifestyle throughout their life. Gradual improvements were emphasised and at least 5% loss of initial body weight was expected, aiming for at least 0.5% loss in the first month.
~It was divided into three phases (preparation, implementation, maintenance) focusing on PA and diet, in which self-efficacy enhancement and self-regulatory skills were emphasised during the first month of intervention."
15828340|NCT04217746|Device|High Flow Nasal Cannula|The HFNC group will receive heated and humidified oxygenated gas delivered at high flow.
15828341|NCT04217733|Drug|pentoxyifylline|Pentoxyifylline two times daily for 3 months
15828342|NCT04217733|Drug|Mebeverine|Mebeverine 3 times for 3 months
15828343|NCT04217733|Drug|ethosuximide|ethosuximide 3 times for 3 months
15828344|NCT04217720|Drug|SNS-301|SNS-301 (1x 1011 dose/1ml) ID injection every 3 weeks for 4 doses then every 6 weeks for 6 additional doses, and thereafter every 12 weeks up to 24 months.
15828625|NCT04215536|Drug|DPP-4 inhibitor|DPP4 inhibitor dispensing claim is reference
15828345|NCT04217707|Behavioral|Pre- and Post-Surgical Transgender Therapeutic Support Group|Participants will be patients drawn from already-existing therapeutic support groups for transgender patients who are hoping to undergo or have undergone gender-affirming surgeries. Participants will be assured that there will be no changes to their care or decisions about their surgeries if they elect not to participate in the research portion of the groups, but would still like to attend groups as a non-research participant. Prior to their first group session, participants will be arrive early to go over consent again and allow participants to sign the consent form and fill out baseline measures of the outcomes of interest. Following this, research participants will participate in the groups as usual, and after each of their first 8 attended sessions, will be asked to fill out outcomes of interest again. Length of time for them to attend 8 sessions will be capped at 6 months, and participants will be asked to fill out measures again at six months following their enrollment.
15828346|NCT04217694|Behavioral|Cogstate Assessment Battery|Complete CogState testing
15828347|NCT04217694|Drug|Memantine|Given PO
15828348|NCT04217694|Drug|Memantine Hydrochloride|Given PO
15828349|NCT04217681|Behavioral|Self-hypnosis/self-care|It is a 7-months 2 hours-session (1 session per month) of self-hypnosis/self-care learning. Participants are given strategies to learn self-care (knowing their needs, self-respect, communication etc.), each strategy is discussed for participant to understand them and thus apply them correctly in daily life. An hypnosis exercise is conducted at the end of each session. A CD with the audiotaped hypnosis exercise is given to each patient so that they can practice also every day.
15828350|NCT04217681|Behavioral|Music/self-care|It is a 7-months 2 hours-session (1 session per month) of music/self-care learning. Participants are given strategies to learn self-care (knowing their needs, self-respect, communication etc.), each strategy is discussed for participant to understand them and thus apply them correctly in daily life. At the end of each session, patients are invited to listen to a relaxing melody of 15 minutes. This melody was composed by a professional musico-therapist. A CD with the audiotaped melody is given to each patient so that they can practice also every day.
15828351|NCT04217681|Behavioral|Self-hypnosis/self-care motivation|It is a 7-months 2 hours-session (1 session per month) of self-hypnosis/self-care learning. Participants are given strategies to learn self-care (knowing their needs, self-respect, communication etc.), each strategy is discussed for participant to understand them and thus apply them correctly in daily life. An hypnosis exercise is conducted at the end of each session. A CD with the audiotaped hypnosis exercise is given to each patient so that they can practice also every day.
15828352|NCT04217681|Behavioral|Self-hypnosis/self-care malignant pain|It is a 7-months 2 hours-session (1 session per month) of self-hypnosis/self-care learning. Participants are given strategies to learn self-care (knowing their needs, self-respect, communication etc.), each strategy is discussed for participant to understand them and thus apply them correctly in daily life. An hypnosis exercise is conducted at the end of each session. A CD with the audiotaped hypnosis exercise is given to each patient so that they can practice also every day.
15828353|NCT04217668|Drug|Isosorbide Mononitrate 60 MG|1 tablet Isosorbide Mononitrate 60 mg administrated orally.
15828354|NCT04217655|Diagnostic Test|Low-dose computed tomography|Radiation dose under the low-dose protocol computed tomography (120 kilovolt, 15 milliampere seconds)
15828355|NCT04217655|Diagnostic Test|Standard-dose computed tomography|Radiation dose under the standard-dose protocol computed tomography (120 kilovolt, 150 milliampere seconds)
15828356|NCT04217642|Procedure|Osteosynthesis|The specific surgical technique -osteosynthesis, hemiarthroplasty, or total hip arthroplasty- will depend on the characteristics of the proximal femur fracture in each patient.
15828357|NCT04217629|Drug|SY-005|This single-dose group will be initiated in healthy subjects at a 0.75mg dose that is the maximum recommended starting dose(MRSD). Doses will be escalated in subsequent dosing process, after appropriate review of safety data. The subsequent planned doses are2.5mg, 5mg, 10mg, 15mg, 20mg successively. The dose of multiple-doses groups are depending on the results of single-dose groups.
15828358|NCT04217603|Device|Continuous positive airway pressure (CPAP) device|Use of a CPAP during a 6 minute walk test to maintain the airways open during the respiratory cycle
15828359|NCT04217603|Device|Sham-continuous positive airway pressure (CPAP) device|An enlarged air leak incorporated into the exhalation valve will be positioned between the mask and the CPAP tubing, allowing airflow resistance of the exhalation port to be almost eliminated by increasing its area, thereby virtually cancelling positive pressure. Also an orifice restrictor in the CPAP circuit will be connected between the CPAP unit and the tubing in order to load the blower with the same airflow resistance as in true CPAP.
15828360|NCT04217590|Drug|Sodium Zirconium Cyclosilicate|Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose) Single dose contains from 1 to 3 sachets of SZC 5g depending on dose level assigned to a patient per non-dialysis days.
15828361|NCT04217590|Drug|Placebo|Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose) Single dose contains from 1 to 3 sachets of Placebo depending on dose level assigned to a patient per non-dialysis days.
15828363|NCT04217564|Behavioral|Nutritional counselling|Nutritional counselling based on the nutritional assessment will be conducted. A booklet that contains the whole instructions and dietary records will be provided to help remembering information and record their application of the plan.
15828364|NCT04217551|Device|Therapeutic Hypothermia|Participants will receive therapeutic hypothermia for the assigned number of hours with controlled rewarming, using a closed-loop temperature control device.
15828365|NCT04217538|Other|clinical exam|clinical oral examination
15828366|NCT04217512|Drug|Pantoprazole low dose|Pantoprazole 0.6 mg/kg
15828367|NCT04217512|Drug|Pantoprazole high dose|Pantoprazole 1.6 mg\kg
15828368|NCT04217512|Other|Standard hydration|Standard hydration alone
15828369|NCT04217512|Drug|Cisplatin|Cisplatin
15828370|NCT04217486|Other|Patient will be shown a photograph of their knee at 2 weeks postop|Patients who undergo primary TKA surgery will then be shown a photograph of their knee at 2 weeks postoperative.
15828371|NCT04217486|Other|Patient will not be shown a photograph of their knee at 2 weeks postop|Patients who undergo primary TKA surgery will not be shown a photograph of their knee at 2 weeks postoperative.
15828372|NCT04217473|Biological|TILT-123|TNFalpha and IL-2 coding oncolytic adenovirus TILT-123
15828374|NCT04217447|Drug|OAC + Aspirin 100mg od|Patients will receive full-dose of OAC + Aspirin 100mg od during 24 to 48 months (until death or the end of the study : i.e. achievement of 2-year follow-up of the last included patient, maximum of 48-month followup for the first included patient)
15828375|NCT04217447|Drug|OAC + placebo of Aspirin 100mg od|Patients will receive full-dose of OAC + placebo of Aspirin 100mg od during 24 to 48 months (until death or the end of the study : i.e. achievement of 2-year follow-up of the last included patient, maximum of 48-month followup for the first included patient)
15828376|NCT04217434|Procedure|400 µm fibre length will be used in continuous contact mode|"Diode LASER (A.R.C Fox, Germany, UK) with wavelength of 810nm is selected for the procedure. Before applying the LASER, operating staff and the patient will wear special LASER protective eye glasses.
~Local infiltration is administered with Lignox®[ 2% lignocaine in 1:80000 adrenaline].
~LASER tip will be used in contact mode on pigmented gingiva in short light paint brush strokes using 400 µm fibre length will be used in continuous contact mode at a power setting of 1.5 - 3W. Simultaneously, increase in temperature on site will be recorded using FLUKE 59 Mini (IR) infrared thermometer in non contact mode. Water spray will be used to keep the area moist. Same procedure will be repeated till no pigments remain.Post operative instructions will be given."
15828377|NCT04217434|Procedure|400 µm fibre length will be used in pulsed contact mode|"Diode LASER (A.R.C Fox, Germany, UK) with wavelength of 810nm is selected for the procedure. Before applying the LASER, operating staff and the patient will wear special LASER protective eye glasses.
~Local infiltration is administered with Lignox®[ 2% lignocaine in 1:80000 adrenaline].
~LASER tip will be used in contact mode on pigmented gingiva in short light paint brush strokes using 400µm fibre length will be used pulsed contact mode at a power setting of 1.5 - 3W. Simultaneously, increase in temperature on site will be recorded using FLUKE 59 Mini (IR) infrared thermometer in non contact mode. Water spray will be used to keep the area moist. Same procedure will be repeated till no pigments remain.Post operative instructions will be given."
15828378|NCT04217434|Procedure|300 µm fibre length will be used in continuous mode|"Diode LASER (A.R.C Fox, Germany, UK) with wavelength of 810nm is selected for the procedure. Before applying the LASER, operating staff and the patient will wear special LASER protective eye glasses.
~Local infiltration is administered with Lignox®[ 2% lignocaine in 1:80000 adrenaline].
~LASER tip will be used in contact mode on pigmented gingiva in short light paint brush strokes using 300 µm fibre length will be used continous contact mode at a power setting of 1.5 - 3W. Simultaneously, increase in temperature on site will be recorded using FLUKE 59 Mini (IR) infrared thermometer in non contact mode. Water spray will be used to keep the area moist. Same procedure will be repeated till no pigments remain.Post operative instructions will be given."
15828379|NCT04217434|Procedure|300 µm fibre length will be used in pulsed contact mode|"Diode LASER (A.R.C Fox, Germany, UK) with wavelength of 810nm is selected for the procedure. Before applying the LASER, operating staff and the patient will wear special LASER protective eye glasses.
~Local infiltration is administered with Lignox®[ 2% lignocaine in 1:80000 adrenaline].
~LASER tip will be used in contact mode on pigmented gingiva in short light paint brush strokes using 300 µm fibre length will be used pulsed contact mode at a power setting of 1.5 - 3W. .Simultaneously, increase in temperature on site will be recorded using FLUKE 59 Mini (IR) infrared thermometer in non contact mode. Water spray will be used to keep the area moist. Same procedure will be repeated till no pigments remain.Post operative instructions will be given."
15828380|NCT04217421|Drug|Allopurinol|Allopurinol powder for solution for infusion (PFI) 20 mg/kg body weight per administration will be administered early postnatally (within 45 minutes and 12 hours after the first dose), preoperatively (12 hours before surgery), intraoperatively (during surgery) and postoperatively (24 hours after surgery) to the neonate in case of a prenatal CCHD diagnosis. Allopurinol PFI will be administered only pre-, intra- and postoperatively to the neonate in case of a postnatal CCHD diagnosis.
15828381|NCT04217421|Drug|Mannitol|Mannitol powder for solution (PFI) placebo will be administered early postnatally (within 45 minutes and 12 hours after birth), preoperatively (12 hours before surgery), intraoperatively (during surgery), and postoperatively (24 hours after surgery) to the neonate in case of a prenatal CCHD diagnosis. Mannitol PFI-placebo will be administered only pre-, intra- and postoperatively to the neonate in case of a postnatal CCHD diagnosis.
15828382|NCT04217408|Device|Deep brain stimulation|Active continuous deep brain stimulation of the ventral capsule/ventral striatum
15828383|NCT04217395|Behavioral|Obese or overweight health subjects involved in the X-Ailes program (at least one contact with the health system navigator)|"The X-Ailes program is a face-to-face or telephone-based support program by health-system navigators and developed by a patients and public association to support overweight or obese care users.
~The main objective of the study is to evaluate the efficacy of the X-ailes program on quality of life of overweight and obese people involved in the program.
~Secondary objectives are to assess their overall health status, their health literacy level and their empowerment. The implementation study is guided by the RE-AIM (Reach, Effectiveness, Adoption, Implementation and Maintenance; Glasgow, Vogt, & Boles, 1999) theoretical framework to determine whether the intervention objectives are being met and to understand the mechanisms of action of the device."
15828384|NCT04217382|Other|patient with melanoma pre transplantation|survival time without melanoma recurrence
15828385|NCT04217369|Device|Diabits Predictions|Participants will be able to view predictions of future blood glucose. These predictions will indicate where the participant's blood glucose will travel over the next hour given that the participant's state does not change. Based on this, the participant is expected, but not required to make decisions about their activity, food, and insulin, in order to maintain blood glucose in a healthy range. The intervention does not require a specific method of glucose management, or event that a participant takes any action after viewing a prediction, the intervention is simply to display the prediction.
15828386|NCT04217356|Biological|Hematopoietic stem cell transplant|Intravenous infusion of hematopoietic stem cells from a donor.
15828387|NCT04217356|Drug|Ruxolitinib|Ruxolitinib is type of drug called a janus kinase (JAK) inhibitor. Ruxolitinib is taken orally (by mouth).
15828388|NCT04217356|Drug|Hydroxyurea|Hydroxyurea is a type of drug called an antimetabolite. Hydroxyurea is taken orally (by mouth).
15828389|NCT04217343|Diagnostic Test|Allosure/Allomap/Cytokines testing|All patients with evidence of Cardiac Transplant rejection will undergo Allosure, Allomap, and cytokine testing. Allosure and Allomap will be performed as part of routine care. Cytokine testing will be performed at time of rejection and resolution.
15828626|NCT04215523|Drug|Dapagliflozin|Dapagliflozin dispensing claim is exposure
15828390|NCT04217330|Behavioral|Choice of home-based or centre-based pulmonary rehabilitation|Participants will be offered the choice of HomeBase, a home-based pulmonary rehabilitation program, or the traditional centre-based pulmonary rehabilitation program.
15828391|NCT04217330|Behavioral|Centre-based pulmonary rehabilitation|Participants will be offered a traditional centre-based pulmonary rehabilitation program
15828392|NCT04217317|Drug|CPI 613|CPI-613 is to be given as 2-hr IV infusion via a central venous catheter. The starting dose of CPI-613 will be 2500 mg/m2 which was determined to be the MTD in the previous phase I clinical trial.
15828393|NCT04217317|Drug|Bendamustine|Bendamustine at 90 mg/m2 is infused by IV over 10 minutes on Days 1 and 2 of each treatment cycle. Bendamustine is given immediately after CPI-613 administration.
15828394|NCT04217304|Drug|Definity® with High Mechanical Index Ultrasound|Sonothrombolysis; Echocardiographic imaging with intermittent diagnostic high mechanical index during an intravenous 5% Definity® infusion
15828395|NCT04217291|Drug|SY-004|Take orally once a day
15828396|NCT04217291|Other|SY-004 matching placebo|Take orally once a day
15828397|NCT04217278|Drug|Vyxeos|Vyxeos administered by intravenous infusion
15828398|NCT04217278|Drug|Fludarabine|Fludarabine administered by intravenous infusion
15828399|NCT04217278|Drug|Busulphan|Busulphan administered by intravenous infusion
15828400|NCT04217278|Drug|Thiotepa|Thiotepa administered by intravenous infusion
15828401|NCT04217278|Drug|Cytarabine|Cytarabine administered by intravenous infusion
15828402|NCT04217265|Drug|Letrozole then misoprostol|total dose 5 mg per day for 3 days then Misoprosrol 800mcg will be given to all patients for induction of abortion
15828403|NCT04217265|Drug|placebo then misoprostol|placebo tablets for 3 days then Misoprosrol 800mcg will be given to all patients for induction of abortion
15828404|NCT04217252|Diagnostic Test|PMseqTM high-throughput sequencing technology|high throughput sequencing of infectious pathogens
15828405|NCT04217239|Procedure|MIE Ivor- Lewis|minimally invasive esophagectomy (MIE) with intrathoracic anastomosis
15828406|NCT04217239|Procedure|MIE McKeown|minimally invasive esophagectomy (MIE) with cervical anastomosis
15828407|NCT04217226|Device|Perfusion index derived parameters|"The PVI and PI will be recorded in the supine position by an anaesthesiologist who was not involved in the further intraoperative monitoring of the patient using Masimo SET (MightySat 9900, Masimo Corporation, Irvine, CA, USA). This device allows bluetooth radio for transfer of parameter data to a smart device. The device will be applied on the index finger of the dominant hand of each patient. It will be applied on the hand that neither contains the venous line nor the blood pressure cuff. Three measurements of PVI and PI on one minute interval will be recorded. We will use the average of these readings.
~Dicpleth is defined as the ratio of the height of the dicrotic notch to the height of the systolic peak, measured at end-expiratory time."
15828408|NCT04217213|Procedure|Intercostal nerve block|In the experimental group, the surgeons used 0.5% ropivacaine combined with mecobalamine (0.5mg) before the operation to perform intercostal nerve block in the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity, and injected 5ml in each intercostal nerve block.In the control group, surgeons used 0.5% ropivacaine alone before the operation to perform intercostal nerve block through the operating incision, closed thoracic drainage incision and one intercostal nerve block in each upper and lower costal cavity. 5ml was injected into each intercostal nerve block.
15828409|NCT04217187|Device|Neuromuscular Electrical Stimulation|Upper extremity neuromuscular electrical stimulation
15828410|NCT04217187|Device|Sham Electrical Stimulation|Sensory only upper extremity electrical stimulation
15828411|NCT04217174|Behavioral|My Personal Health Guide|My Personal Health Guide is a theory-based mobile phone app that uses an Avatar as a personal health guide to increase patient knowledge of HIV disease and its complications and rationale for healthy behavior, increase self-efficacy and motivate participants to improve retention in care and medication adherence, and explain and illustrate behavioral skills related to retention in care, and adherence, with a result of improved behavior that leads to personal and population benefits through viral suppression and decreased risk of transmission, respectively. The relational aspect of the Avatar may be a powerful supplement to clinical care. The Avatar can encourage healthy behavior, acknowledge stigma and speak with empathy, audibly teach persons with low literacy, employ credible culturally appropriate phrasing, and invite the user to hear advice and motivational stories of other HIV-positive people and caregivers.
15828412|NCT04217174|Behavioral|My Personal Food Guide|My Personal Food Guide is a mobile phone app that contains a talking realistic avatar who teaches about food safety, sugar content in selected foods, and some other food related information. The avatar motivates safe food behavior in order reduce the likelihood of food poisoning and promotes a healthy diet.
15828413|NCT04217161|Device|Dexcom G6 Continuous Glucose Monitor|Eligible patients will undergo DDexcom G6 Continuous Glucose Monitor device placement
15828414|NCT04217148|Drug|Dexamethasone|Dexamethasone, iv, 40 mg/d, for 4 days (The 4-day course of dexamethasone was repeated in the case of lack of response by day 10)
15828415|NCT04217148|Drug|ATRA|ATRA, po,10mg bid, for 12 weeks
15828416|NCT04217135|Drug|evidence-based medications vs. high-dose hydralazine + evidence-based medications|randomized in 1 to 1 fashion After discharge, high-dose hydralazine is maintained except any adverse effect and up-titration of other evidence-based medications to maximal tolerable dose will be done. The dose of medications is adjusted by clinical signs, especially peripheral perfusion, not only simply by blood pressure. If participant had low blood pressure (for example, systolic blood pressure less than 90 mmHg) but no sign of postural hypotension, or low cardiac output (cold limbs, decreased urine output, dizzy), the investigators will keep up-titration of medications.
15828417|NCT04217122|Other|strawberry powder|Participants consume 2 packages of standard strawberry powder (13 g x 2) daily for 4 weeks
15828418|NCT04217122|Other|placebo powder|Participants consume 2 packages of placebo powder (13 g x 2) daily for 4 weeks
15828419|NCT04217109|Diagnostic Test|Odour sampling|"Upon receipt of the samples at the Institute Curie-Paris, the compresses will be packed in jars and then transmitted to the dog center and analyzed by the study dogs.
~Positive marking is characterized by a sitting position of the dog in front of the sample."
15828420|NCT04217096|Drug|Paclitaxel liposome|Patients receive paclitaxel liposome 175 mg/m^2 (iv, 3h) on day 1 for 3 weeks. Treatment repeats every 3 weeks until the disease recurrence or unacceptable toxicity，death or begin a novel therapeutic
15828421|NCT04217096|Drug|S-1|Patients receive S-1 at a dose according to the body surface area（<1.25m^2，40mg Bid；1.25~1.5m^2,50mg Bid；>1.50m^2,60mg Bid）on days 1-14 for 3 weeks. Treatment repeats every 3 weeks until the disease recurrence or unacceptable toxicity，death or begin a novel therapeutic.
15828422|NCT04217083|Diagnostic Test|Breath sampling|The alveolar fraction of Colorectal cancer patients and Healthy controls will be sampled using a breath sampler able to fix the volatile organic compound on absorbable tubes
15828423|NCT04217070|Other|Questionnaire|Questionnaire including demographic data, data regarding poisoning substance and outcomes of suicidal attempts
15828424|NCT04217057|Drug|64Cu-DOTA-ECL1i|Will be produced by the Cyclotron Facility at Washington University School of Medicine
15828425|NCT04217044|Diagnostic Test|Histopathology images based prediction of molecular pathology|Histopathology images based prediction of 1p/19q co-deletion, MGMT methylation, IDH and TERTp mutations or molecular subgroups by leveraging AI
15828426|NCT04217031|Other|No intervention|No intervention
15828427|NCT04217018|Diagnostic Test|Prediction of molecular pathology|Prediction of 1p/19q co-deletion, MGMT methylation, IDH and TERTp mutations or molecular subgroups by leveraging AI
15828428|NCT04217005|Device|Sensory Feedback|Subjects will receive a sensory feedback provided by electrical stimulation
15828429|NCT04216992|Device|Cone beam computed tomography|The contrast agent (Omnipaque, GE Healthcare, Ireland) was instilled to conﬁrm the epidural space. With use of a calibrated angiographic C-arm system and a postprocessing workstation, we acquired volume data sets from two dimensional digital projection images obtained to reconstruct the 3D-RE during a C-arm rotation around the patient axis.
15828430|NCT04216979|Procedure|laparoscopy entry policy|"Patients will be randomly arranged in 2 groups Group (A):- Palmer's point is the primary entry site.
~Group (B):- The umbilicus is the primary entry site."
15828431|NCT04216966|Device|Control group|No intervention was given
15828432|NCT04216966|Device|Gracey Curette|Lingual surface of tooth was debrided by Gracey Rigid curette
15828433|NCT04216966|Device|After Five|Lingual surface of tooth was debrided by After Five Rigid curette
15828434|NCT04216966|Device|Mini Five|Lingual surface of tooth was debrided by Mini Five Rigid curette
15828435|NCT04216953|Drug|Cobimetinib|"Adults: 20mg film coated tablet
~Paediatrics:
~i) powder for oral suspension containing 250mg of cobimetinib
~ii) for pediatric patients ≥12 years-old and with a BW ≥60kg : 20mg film coated tablet same as adults"
15828436|NCT04216953|Drug|Atezolizumab|20-mL glass vial containing 1200 mg of atezolizumab.
15828437|NCT04216940|Device|mechanical preparation of root canal system|Assess the pain intensity in a two-visit treatment of molars with irreversible pulpitis after instrumentation with two different rotary Nickle Titanium systems
15828438|NCT04216927|Drug|Nitric Oxide|gNO will be entrained at 20 ppm into the oxygenator of the CPB circuit
15828439|NCT04216927|Drug|Oxygen|Oxygen alone will be entrained for placebo arm
15828440|NCT04216914|Device|Hand outline|A simple outline of a hand, to which the child tried to match their own hand on order to improve positioning.
15828441|NCT04216901|Diagnostic Test|Endoscopists refer to AI for diagnosis|The AI will provide a pathological prediction of the lesion during colonoscopy.
15828442|NCT04216888|Drug|Ketamine Hydrochloride|Intranasal administration of 40mg ketamine hydrochloride using an intranasal mucosal atomization device
15828443|NCT04216875|Procedure|Best Practice Diabetes Management in Primary Care|Practice adherence to best practice guidelines treating diabetes patients in different primary care practices is shown in this before- and after observational study
15828444|NCT04216862|Other|Exercise|Different type of exercises for treatment of Forward Head Posture
15828445|NCT04216849|Biological|human umbilical cord mesenchymal stem cells|human umbilical cord mesenchymal stem cells were peripheral intravenous infused to experimental group
15828446|NCT04216849|Other|saline|Saline solution containing human serum albumin will be infused to the control group
15828447|NCT04216836|Dietary Supplement|Magnesium oxide|Magnesium capsule
15828448|NCT04216836|Dietary Supplement|Placebo|Cornflour capsule manufactured to mimic the 166.6 mg magnesium capsule.
15828449|NCT04216823|Device|perfusion index|perfusion index in the prediction of peripheral block success was previously reported for infraclavicular brachial plexus block, axillary brachial plexus block, interscalene brachial plexus block, and supraclavicular brachial plexus in adult patients
15828450|NCT04216810|Other|muscle strengthening exercises|segmental stabilization exercises
15828451|NCT04216810|Other|muscle strengthening exercises and dry cupping|segmental stabilization exercises and dry cupping
15828452|NCT04216797|Drug|Diazepam Tablets|Participants will be randomly assigned to either an oral or rectal administration of once daily 10 mg diazepam tablets for four weeks.
15828453|NCT04216784|Drug|Furosemide Injection|Patient will receive furosemide intravenously
15828454|NCT04216784|Drug|Albumin Human|Patient will receive albumin (25%) 12.5 gm intravenously
15828455|NCT04216771|Drug|Idarubicin|Idarubicin 10mg/m²/day, D1 (IV)
15828456|NCT04216771|Drug|ID cytarabine|Cytarabine 1.5g/m² /12h, D1-D3 (IV)
15828457|NCT04216758|Drug|nab-paclitaxel|Patients firstly receive nab-paclitaxel 100 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.
15828458|NCT04216758|Drug|Gemcitabine|Patients receive gemcitabine 1000 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.
15828459|NCT04216758|Drug|tegafur|Patients secondly receive tegafur Body surface area < 1.25 m^2, 60 mg/d;Body surface area ≥ 1.25 m^2 to < 1.5 m^2, 80 mg/d;Body surface area ≥ 1.5 m^2, 100 mg/d (po) on days 1-21 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.
15828460|NCT04216745|Diagnostic Test|bile culture|Bile samples will be collected for microbial cultures and antimicrobial susceptibility testing using COMPACT-15 automated system (Bio Merieux, Marcy I'Etoile, France) for bacteria and saboroud's agar for fungal culture.
15828461|NCT04216732|Other|Blood Pressure Measurement|Undergo blood pressure measurement
15828462|NCT04216732|Other|Questionnaire Administration|Complete questionnaires
15828463|NCT04216719|Behavioral|OCM-RISE|OCM RISE will comprise four phases (Exploratory, Preparation, Implementation, and Sustainment). During Exploration, staff will conduct readiness surveys, interviews and system mapping exercises to assess county context. In the Preparation Phase, the needs assessment data will inform county-specific action plans. Guided facilitation during this phase includes court development planning, practice/process improvement strategies, and training on data-driven decision-making to help IACTs operationalize the 10 OCM guidelines, assess performance, and fit the guideline to the local context. In the Implementation Phase, counties will roll out the OCM for 18 months with data feedback, support, and facilitation. Each IACT will receive reports on the performance of its OCM and complete two plan-do-study-act cycles. In the Sustainment Phase, implementation and feedback reports will continue for 6-18 months, but without other external facilitation.
15828464|NCT04216706|Drug|tailored pharmaceutical treatment|Tailored medication is advised in women with inadequate hemodynamic adaptation to pregnancy. Type of medication depends on total peripheral vascular resistance and heart rate. In short, women with a low peripheral vascular resistance in parallel with a high heart rate are advised a betablocker (labetalol), while a vasodilating agent (calcium channel blocker, nifedipine) was advised in women with a high total peripheral vascular resistance in combination with a low heart rate. Women with suboptimal adaptation to pregnancy without an extreme pronounced vascular profile are advised a centrally acting sympatholytic agent (methyldopa).
15828465|NCT04216693|Drug|Digoxin tablet|The NASH patients in experimental group will take digoxin tablets orally with the goal of achieving a serum digoxin concentration of 0.7-1 ng/ml for 24 weeks.
15828466|NCT04216693|Other|Placebo|The control group will receive the digoxin-like placebo treatment.
15828467|NCT04216667|Procedure|Catheter ablation|Catheter ablation
15828468|NCT04216654|Diagnostic Test|ELISA (enzyme-linked immunosorbent assay)|ELISA Principle. Enzyme-linked Immunosorbent Assays (ELISAs) combine the specificity of antibodies with the sensitivity of simple enzyme assays, by using antibodies or antigens coupled to an easily-assayed enzyme. ELISAs can provide a useful measurement of antigen or antibody concentration.
15828469|NCT04216641|Dietary Supplement|Adapted food intervention|Adapted food intervention
15828470|NCT04216628|Other|Amniotomy|Artificial rupturing of membranes and IV infusion of Oxytocin
15828471|NCT04216615|Behavioral|preoperative anxiety|patients who are anxious
15828473|NCT04216576|Other|Paper Drug Diary|Participants will receive and use a paper Drug Diary and a paper medication calendar.
15828474|NCT04216576|Other|OhMD APP|Participants will receive multiple text messages regarding administration over time on medication self-management over the course of 3 cycles of medication
15828475|NCT04216563|Drug|Asciminib|Given PO
15828476|NCT04216550|Drug|Apatinib|Apatinib 0.5g orally daily until the untolerable toxicities, disease progression or death
15828477|NCT04216537|Diagnostic Test|Glioma groups based on molecular pathology or genetic variation|Patients with newly diagnosed glioma that receive tumor resection
15828478|NCT04216524|Drug|Cyclophosphamide|Given IV
15828479|NCT04216524|Drug|Cytarabine|Given IT or IV
15828480|NCT04216524|Drug|Dexamethasone|Given PO or IV
15828481|NCT04216524|Drug|Doxorubicin|Given IV
15828482|NCT04216524|Drug|Mercaptopurine|Given PO
15828483|NCT04216524|Drug|Methotrexate|Given IT, IV, or PO
15828484|NCT04216524|Drug|Methylprednisolone|Given IV
15828485|NCT04216524|Drug|Prednisone|Given PO
15828486|NCT04216524|Biological|Rituximab|Given IV
15828487|NCT04216524|Biological|Tagraxofusp-erzs|Given IV
15828488|NCT04216524|Drug|Venetoclax|Given PO
15828489|NCT04216524|Drug|Vincristine|Given IV
15828490|NCT04216511|Diagnostic Test|Tumor autoantibody detection|Level of a set of autoantibodies potentially relative with lung cancer will be tested for each of the participants.
15828491|NCT04216485|Behavioral|Intensive Lifestyle Intervention|Dietary intervention combined with healthy lifestyle counseling
15828492|NCT04216485|Behavioral|Standard Care|Standard prenatal care on diet, nutrition and physical activity
15828493|NCT04216472|Drug|Alpelisib|Given PO
15828494|NCT04216472|Drug|Nab-paclitaxel|Given IV
15828495|NCT04216459|Drug|oral lactobacillus probiotics plus intramuscular cholecalciferol|According to leukocyte anti- sedimentation rate (LAR) result on day 1 patients will be classified into high risk for sepsis patients (LAR < 15 %) and low risk for sepsis patients (LAR ≥ 15%) High risk sepsis patients will be randomly allocated into one of the 3 groups (sealed opaque envelops) to vitamin D plus probiotics intervention group (HR-DP) group. to vitamin C plus vitamin B intervention group (HR-CB) group. to control group (HR-C) group that does not receive any supplement
15828496|NCT04216459|Drug|intravenous vitamin C plus thiamine|starting from day 1 in a dose of 1 gm vitamin C and 200 mg thiamine intravenous 4 times at 12-hour intervals for 48 hours
15828497|NCT04216446|Behavioral|Mobile Health Intervention|A mobile based application will be developed that will function on android as well as the iPhone operating system. The application will be provided to eligible pregnant women randomized to the intervention group. The dietary, supplement use and physical activity coaching will be provided over the period of 6 months through the application.
15828498|NCT04216433|Procedure|endovascular surgery|"an innovative, less invasive procedure used to treat problems affecting the blood vessels, such as an aneurysm, which is a swelling or ballooning of the blood vessel. The surgery involves making a small incision near each hip to access the blood vessels."
15828499|NCT04216420|Device|Electronic pillbox-enabled SAT|It is a digital device manufactured by Wisepill Technologies, South Africa. Every time a pill dispenser is opened, the evriMED500 stores the date and time of the opening. Adherence data and reports can be viewed on the Wisepill Cloud Server and on the mobile-friendly browser application.
15828500|NCT04216407|Procedure|Remote ischemic preconditioning|An orthopedic tourniquet was tied to the right lower extremities of the patients in RIPC arm, and tourniquet application was performed before the anhepatic phase in 3 periods of 3 minutes with an interval of 3 minutes.
15828501|NCT04216394|Procedure|Emergency general surgery|multidisciplinary surgery performed for traumatic and non-traumatic acute conditions during the same admission in the hospital.
15828502|NCT04216381|Diagnostic Test|Trauma Specific Frailty Index Questionnaire|questionnaire to assess patient's pre-injury health condition
15828503|NCT04216368|Behavioral|balance training|The training to improve balance is to work on the core muscle groups that help to maintain your posture.,and increase muscular strength.
15828504|NCT04216368|Behavioral|resistance training|Resistance training is a form of exercise that improves muscular strength and endurance. During a resistance training workout, you move your limbs against resistance provided by your body weight, gravity, bands, weighted bars or dumbbells.
15828505|NCT04216355|Drug|Azacitidine|Low-dose AZA
15828506|NCT04216355|Drug|CAG Protocol|Short term CAG derived regimen
15828511|NCT04216316|Drug|Berzosertib|Given IV
15828512|NCT04216316|Drug|Carboplatin|Given IV
15828513|NCT04216316|Drug|Gemcitabine Hydrochloride|Given IV
15828514|NCT04216316|Biological|Pembrolizumab|Given IV
15828515|NCT04216303|Diagnostic Test|hemoglobin A1c|The hemoglobin A1c test (A1c) screens for, helps diagnose, and monitors diabetes and prediabetes.
15828516|NCT04216290|Drug|Carboplatin|Given IV
15828517|NCT04216290|Drug|Cisplatin|Given IV
15828518|NCT04216290|Drug|Doxorubicin Hydrochloride|Given IV
15828519|NCT04216290|Biological|Durvalumab|Given IV
15828520|NCT04216290|Drug|Fluorouracil|Given IV
15828521|NCT04216290|Drug|Gemcitabine Hydrochloride|Given IV
15828522|NCT04216290|Drug|Methotrexate|Given IV
15828523|NCT04216290|Drug|Mitomycin|Given IV
15828524|NCT04216290|Other|Patient Observation|Undergo observation
15828525|NCT04216290|Radiation|Radiation Therapy|Undergo radiation therapy
15828526|NCT04216290|Drug|Vinblastine Sulfate|Given IV
15828527|NCT04216277|Diagnostic Test|Procalcitonin|"In addition to usual care diagnostic and handling of acute respiratory tract infections in general practice to attending physician in the intervention arm has access to antibiotic stewardship by a procalcitonin point-of-care test. The following criteria for initiating og withholding antibiotics will be used.
~Antibiotics treatment is recommended with Procalcitonin levels above 0.25 ng/ml
~Antibiotic treatment is discouraged if Procalcitonin levels are below 0.25 ng/ml"
15828528|NCT04216264|Behavioral|Standard response|Parents pick from a menu of behavior changes
15828529|NCT04216264|Behavioral|Targeted response|Stepped up phone interaction with parents based on menu of behavior changes
15828530|NCT04216251|Drug|AMR101|AMR101-oral predetermined protocol dosage, daily for a minimum of 8 weeks and maximum of 12 weeks
15828531|NCT04216238|Behavioral|quasi-experimental Pre-test/Post-test design|surveys to document progress
15828532|NCT04216225|Other|pre-hospital tourniquet placement|patients with extremity injuries presenting with or without pre-hospital tourniquet placement.
15828533|NCT04216199|Device|Point of care Ultrasound|Point of care Ultrasound
15828534|NCT04216186|Drug|Atomoxetine|Atomoxetine once daily
15828535|NCT04216186|Drug|Coenzyme Q|Coenzyme Q once daily
15828536|NCT04216173|Other|Acupuncture|Acupuncture weekly for 12 consecutive weeks. Acupuncture protocol consists of both scalp and body acupuncture points.
15828537|NCT04216160|Other|ACN cream (YUN)|Application of the facial cream ACN (YUN) twice a day, for 8 weeks +/- 2 days. Assessment before product use (T0), after 2, 4 and 8 weeks +/- 2 days of product use (T2w, T4w and T8w, respectively) and after 4 weeks +/- 2 days without product use (T12w).
15828538|NCT04216160|Other|Placebo cream (YUN)|Application of the facial placebo cream twice a day, for 8 weeks +/- 2 days. Assessment before product use (T0), after 2, 4 and 8 weeks +/- 2 days of product use (T2w, T4w and T8w, respectively) and after 4 weeks +/- 2 days without product use (T12w).
15828539|NCT04216147|Other|PNE|Percutaneous Needle Electrolysis: the application of galvanic current through an acupuncture needle.
15828540|NCT04216147|Procedure|Surgery for CTS|Median nerve release
15828541|NCT04216134|Drug|Gallium Ga 68-labeled PSMA-11|Given IV
15828542|NCT04216134|Procedure|Positron Emission Tomography|Undergo 68GA-PSMA-11 PET
15828545|NCT04216108|Device|Vitrectomy (23G gauge needle)|Vitrectomy surgery with 23G gauge needle technique
15828546|NCT04216108|Device|Vitrectomy (27G gauge needle)|Vitrectomy surgery with 27G gauge needle technique
15828547|NCT04216095|Device|Electroconvulsive Therapy (n=30)|Right unilateral (RUL) ECT (n=15) or bitemporal (BT) ECT (n=15) using a Thymatron IV device (Somatics LLC, USA) twice weekly.
15828548|NCT04216095|Device|Magnetic Seizure Therapy (n=30)|High-dose magnetic seizure therapy (HD-MST) over the vertex using Magstim Theta device (Magstim Company Limited, Whitfield, Wales, UK) at 100% maximal output of the device (constant), with pulse frequency 100Hz and train duration 10 seconds twice weekly.
15828549|NCT04216082|Drug|Anlotinib|Anlotinib is a oral small molecule receptor tyrosine kinases inhibitor with the potency of inhibiting tumor angiogenesis as well as cell proliferation simultaneously and have been approved to treat advanced non-small cell lung cancer (NSCLC) in China. Anlotinib capsules given orally in fasting conditions , once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).
15828671|NCT04215120|Drug|Desidustat Oral Tablet|Desidustat tablet
15828550|NCT04216069|Other|Total 12 regimen|"The volunteers will be invited with their caregivers to a lecture administered with the aim of clarifying the importance of oral hygiene and motivating brushing among the volunteers. Written clarifications will also be given in the form of an illustrative pamphlet. The volunteers will be trained in the technique through supervised brushing in front of a mirror. Subjects from the Group 1 will use a regimen with Colgate Total 12 toothpaste + Plax mouthwash + Colgate Ultrasoft toothbrush. Subjects will be instructed to use only their assigned group during the study period. The treatment products will be re-supplied at regular intervals. Subjects will return with their assigned products to the study site before receiving new products.
~There will be no restrictions regarding diet habits during the course of the study. Upon completion of the study, subjects will be instructed to return all used and used products."
15828551|NCT04216069|Other|Toothbrushing alone|"The volunteers will be invited with their caregivers to a lecture administered with the aim of clarifying the importance of oral hygiene and motivating brushing among the volunteers. Written clarifications will also be given in the form of an illustrative pamphlet. The volunteers will be trained in the technique through supervised brushing in front of a mirror. Group 2 will use Colgate Cavity Protection Toothpaste + Colgate Ultrasoft toothbrush. Subjects will be instructed to use only their assigned group during the study period. The treatment products will be re-supplied at regular intervals. Subjects will return with their assigned products to the study site before receiving new products.
~There will be no restrictions regarding diet habits during the course of the study. Upon completion of the study, subjects will be instructed to return all used and used products."
15828552|NCT04216056|Behavioral|Frailty intervention program|There will be 2 sessions per week for 12 weeks. Each session includes 1 hour exercise (including 5-10 minute warm-up and cool-down routine, 20-30 minute chair-based resistance exercises using Thera-Bands for muscle groups in both the upper and lower body, and 20-30 minutes aerobic exercises); and 1 hour game training using computer video games, board games and card games. Nutrition education will be given to the subjects based on their weight status. The 1st level of nutrition information (healthy eating tips for frailty prevention and management) will be given to all subjects on regular basis during the 12-week study period via short videos, text messages or Whatsapp reminders. On top of the 1st level nutrition information, 3 nutrition heath talks (1-1.5 hours per talk) about weight management will be given to those with BMI >=25 kg/m2, and/or waist circumference >=90 cm (male) or >=80 cm (female) during the 12-week study period.
15828553|NCT04216043|Dietary Supplement|RUSF skimmed milk powder|ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
15828554|NCT04216043|Dietary Supplement|RUSF milk protein concentrate and sucrose|ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
15828555|NCT04216043|Dietary Supplement|RUSF soy protein and whey permeate|ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
15828556|NCT04216043|Dietary Supplement|RUSF soy and sucrose|ready-to-use supplementary foods 75 kcal/kg/day (314 kJ/kg/day) and full daily doses of vitamins and micronutrients
15828557|NCT04216030|Other|High Fe IP meal labelled with Fe-58|500 gram steamed, mashed OFSP high Fe with 0.33 mg FeSO4-58 daily for 10 days
15828558|NCT04216030|Other|Control OFSP meal labelled with Fe-57|500 gram steamed, mashed OFSP control with 0.33 mg FeSO5-57 daily for 10 days
15828559|NCT04216017|Drug|kenalog|Cortisone injection into shoulder
15828560|NCT04216017|Drug|Lidocaine|Lidocaine injection into shoulder
15828561|NCT04216004|Behavioral|Controlled-Feeding Intervention|All energy-containing food and beverages will be provided for 1-week as a controlled-feeding study.
15828562|NCT04216004|Dietary Supplement|Non-dairy beverage|Isolated amino acid, fatty acid, and monosaccharide beverage matched to the macronutrient content of 8 fl oz whole milk.
15828563|NCT04216004|Other|Full-fat milk|3 daily servings (cup-eq) of full-fat (3.25%) commercial cow's milk.
15828564|NCT04216004|Other|Fat-free milk|3 daily servings (cup-eq) of fat-free (0%) commercial cow's milk.
15828565|NCT04215991|Drug|Cefiderocol|Administered intravenously over 3 hours
15828566|NCT04215991|Drug|Standard of Care|Standard of care administered will be selected by the investigator based on the suspected or confirmed pathogen(s) for the infection in accordance with local standards.
15828567|NCT04215978|Drug|BGB-A445|Administered as specified in the treatment arm
15828568|NCT04215978|Drug|tislelizumab|Administered as specified in the treatment arm
15828569|NCT04215965|Drug|Biphozyl (dialysate and replacement)|Replacement solution with phosphate and without calcium in CRRT with citratre-based antigoagulation
15828570|NCT04215965|Drug|Prismocal B22 (dialysate) + phoxilium (replacement)|solution with phosphate and calcium in CRRT with citratre-based antigoagulation
15828571|NCT04215952|Behavioral|Semantic Feature Analysis Treatment|On each treatment trial, the clinician will show the participant with aphasia a pictured object and ask them to name it. The clinician will then guide the participant in verbally generating semantic features for the target, using a chart that specifies five kinds of features: group, use/action, properties, location, and personal associations. When the participant cannot generate a given feature, cueing or other assistance will be provided. After feature generation, the clinician will ask the participant to name the picture again and provide cueing if needed. The clinician will then review the generated features and ask the participant to name the item once more, with cueing if needed. Finally, the clinician will ask the participant to say a sentence containing the target word and provide cueing if needed. Treatment will then proceed to the next item. Participants will receive approximately 20 hours of treatment on each of three 10-item lists, for a total of 60 hours of treatment.
15828572|NCT04215939|Behavioral|Cold environment participants with spinal cord injury|In a cold environment (15-17°C and 40-50% relative humidity), participants will stay in a sited position for 20 minutes in order to collect baseline data and to allow their blood flow and body temperature adapt to the exposing environmental condition. Immediately after the baseline period participants will immerse their left hand and foot in warm water (34-36°C) for five minutes for a consistent starting (hand and foot) temperature. Following that participants will immerse their hand and foot in cold water (8°C) for 40 minutes.
15828592|NCT04215770|Drug|inj co-amoxiclav 50 units/kg/day vs inj Benzyl Penicillin 25000 units/kg/day|Patients of both groups were examined and compared in terms of efficacy of treatment, safety and cost effectiveness
15828593|NCT04215757|Procedure|peripheral nerve block|peripheral nerve blocks with low dose lignocaine in acute radiculopathy
15828573|NCT04215939|Behavioral|Thermoneutral environment participants with spinal cord injury|In a thermoneutral environment (22-24°C and 40-50% relative humidity), participants will stay in a sited position for 20 minutes in order to collect baseline data and to allow their blood flow and body temperature adapt to the exposing environmental condition. Immediately after the baseline period participants will immerse their left hand and foot in warm water (34-36°C) for five minutes for a consistent starting (hand and foot) temperature. Following that participants will immerse their hand and foot in cold water (8°C) for 40 minutes.
15828574|NCT04215939|Behavioral|Warm environment participants with spinal cord injury|In a warm environment (33-35°C and 40-50% relative humidity), participants will stay in a sited position for 20 minutes in order to collect baseline data and to allow their blood flow and body temperature adapt to the exposing environmental condition. Immediately after the baseline period participants will immerse their left hand and foot in warm water (34-36°C) for five minutes for a consistent starting (hand and foot) temperature. Following that participants will immerse their hand and foot in cold water (8°C) for 40 minutes.
15828575|NCT04215939|Behavioral|Cold environment healthy male participants|In a cold environment (15-17°C and 40-50% relative humidity), participants will stay in a sited position for 20 minutes in order to collect baseline data and to allow their blood flow and body temperature adapt to the exposing environmental condition. Immediately after the baseline period participants will immerse their left hand and foot in warm water (34-36°C) for five minutes for a consistent starting (hand and foot) temperature. Following that participants will immerse their hand and foot in cold water (8°C) for 40 minutes.
15828576|NCT04215939|Behavioral|Thermoneutral environment healthy male participants|In a thermoneutral environment (22-24°C and 40-50% relative humidity), participants will stay in a sited position for 20 minutes in order to collect baseline data and to allow their blood flow and body temperature adapt to the exposing environmental condition. Immediately after the baseline period participants will immerse their left hand and foot in warm water (34-36°C) for five minutes for a consistent starting (hand and foot) temperature. Following that participants will immerse their hand and foot in cold water (8°C) for 40 minutes.
15828577|NCT04215939|Behavioral|Warm environment healthy male participants|In a warm environment (33-35°C and 40-50% relative humidity), participants will stay in a sited position for 20 minutes in order to collect baseline data and to allow their blood flow and body temperature adapt to the exposing environmental condition. Immediately after the baseline period participants will immerse their left hand and foot in warm water (34-36°C) for five minutes for a consistent starting (hand and foot) temperature. Following that participants will immerse their hand and foot in cold water (8°C) for 40 minutes.
15828578|NCT04215939|Behavioral|Cold environment healthy female participants|In a cold environment (15-17°C and 40-50% relative humidity), participants will stay in a sited position for 20 minutes in order to collect baseline data and to allow their blood flow and body temperature adapt to the exposing environmental condition. Immediately after the baseline period participants will immerse their left hand and foot in warm water (34-36°C) for five minutes for a consistent starting (hand and foot) temperature. Following that participants will immerse their hand and foot in cold water (8°C) for 40 minutes.
15828579|NCT04215939|Behavioral|Thermoneutral environment healthy female participants|In a thermoneutral environment (22-24°C and 40-50% relative humidity), participants will stay in a sited position for 20 minutes in order to collect baseline data and to allow their blood flow and body temperature adapt to the exposing environmental condition. Immediately after the baseline period participants will immerse their left hand and foot in warm water (34-36°C) for five minutes for a consistent starting (hand and foot) temperature. Following that participants will immerse their hand and foot in cold water (8°C) for 40 minutes.
15828580|NCT04215939|Behavioral|Warm environment healthy female participants|In a warm environment (33-35°C and 40-50% relative humidity), participants will stay in a sited position for 20 minutes in order to collect baseline data and to allow their blood flow and body temperature adapt to the exposing environmental condition. Immediately after the baseline period participants will immerse their left hand and foot in warm water (34-36°C) for five minutes for a consistent starting (hand and foot) temperature. Following that participants will immerse their hand and foot in cold water (8°C) for 40 minutes.
15828581|NCT04215926|Other|No intervention; cross-sectional study|No intervention; cross-sectional study
15828582|NCT04215913|Other|The investigators will extract total protein, DNA and RNA from PSC patients.|The investigators will extract total protein, DNA and RNA from PSC patients.
15828583|NCT04215900|Behavioral|High-speed yoga multi-directional yoga|The yoga training will be performed over a 4-month period where classes will be held two times per week. Each session will include a warm-up, speed and balance training section, and cooldown phase. The yoga program will include four separate progressions with the first four weeks serving as a familiarization phase, where the participants will be introduced to the poses and proper technique will be demonstrated. The second four-week phase will emphasize a speed component used to target improvements in aerobic capacity. The same poses previously learned will be used. The final two phases will increase in intensity maintaining the speed element and include skill-based training, where the participants will be asked to complete each pose moving as quickly as possible in response to visual and auditory cues.
15828584|NCT04215887|Device|Contactless Portable Respiratory rate Monitor|Novel hand-held respiratory rate monitor
15828587|NCT04215835|Drug|letrozole then misoprostol|"Drug: Letrozole 2.5mg total dose 7.5 mg per day for 3 days
~Drug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion"
15828588|NCT04215835|Drug|placebo then misoprostol|"Drug: Placebo placebo for 3 days
~Drug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion"
15828589|NCT04215822|Diagnostic Test|Cytogenetic analysis (FISH) for EZH2 gene deletion. -Real time PCR for PHF 19 gene expression.|Cytogenetic analysis (FISH) for EZH2 gene deletion. -Real time PCR for PHF 19 gene expression.
15828590|NCT04215809|Drug|APG2575|APG2575 investigation drug in ramp up dosing
15828591|NCT04215796|Device|ReX-C system|CFTR modulators are dispensed to patients via ReX-C system
15828594|NCT04215744|Behavioral|Ice water immersion|Ice water immersion of the left hands
15828595|NCT04215731|Drug|Neoadjuvant chemotherapy with mFOLFOXIRI plus bevacizumab|Bevacizumab (5 mg/kg on day 1) plus mFOLFOXIRI (oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) for 4 cycles and mFOLFOXIRI (oxaliplatin 85 mg/m2, irinotecan 150 mg/m2, and folinic acid 400 mg/m2 followed by 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) for 2 cycles
15828596|NCT04215731|Procedure|Restaging|Restaging by pelvic magnetic resonance imaging (MRI)
15828597|NCT04215731|Radiation|Concomitant Chemoradiotherapy|Concomitant chemoradiotherapy (preoperative radiotherapy consisted of 50 Gy in 25 fractions, and concurrent with capecitabine at a fixed dose of 825 mg/m2 twice daily on days 1 to 5 for 5 weeks)
15828598|NCT04215731|Procedure|Surgery|Radical surgery (TME or more extended surgery)
15828599|NCT04215731|Radiation|Chemoradiotherapy (only when patients with MRF involved or ycT4a/b by restaging)|Chemoradiotherapy (preoperative radiotherapy consisted of 50 Gy in 25 fractions, and concurrent with capecitabine at a fixed dose of 825 mg/m2 twice daily on days 1 to 5 for 5 weeks)
15828600|NCT04215731|Drug|Induction chemotherpay with FOLFOX|mFOLFOX6 (oxaliplatin 85 mg/m2, and folinic acid 400 mg/m2 followed by bolus 5-fluorouracil 400 mg/m2 and 5-fluorouracil 2400mg/m2 as a 46-hour continuous infusion on day 1) for 4 cycles
15828601|NCT04215718|Procedure|fistulotomy and marsupialization|the anal fistula was laid open and the the wound edges was marsupialized using vicryle 3\0 sutures
15828602|NCT04215718|Procedure|fistulectomy and wound closure|anal fistula was excised with both openings and the wound was closed
15828603|NCT04215705|Procedure|Quadratus block versus peritubal local infiltration|Quadratus lumborum block III versus peritubal local infiltration in patients undergoing Percutaneous Nephrolithotomy operation
15828604|NCT04215692|Diagnostic Test|Pulmonary ultrasound|Pulmonary ultrasound is a basic application of critical ultrasound, defined as a loop associating urgent diagnoses with immediate therapeutic decisions.
15828605|NCT04215679|Other|Three-dimensional immersive virtual reality application|In this group, individuals will be included in a game program that will last for 3 days a week for a total of 6 weeks and 45 minutes a day. Individuals will use the IVR to rehabilitate functions that are frequently used in daily life through task-oriented games. The IVR device will be placed on the head of the individual by closing the eyes of the individual and the Leap Motion device will be used to enable individuals to see their own hands in a virtual reality environment. In order to ensure the safety of individuals, practices shall be carried out with the individual sitting in the chair and leaning against the back. A total of 3 different games will be used for upper extremity function, each game will be 15 minutes and the total session time will be 45 minutes.
15828606|NCT04215679|Other|Motor imagery|Motor imagery will be performed with the eyes closed. In addition, for the safety of the individual, the individual will sit comfortably in a chair in a quiet environment and sit back. In the motor imagery group, individuals will be shown videos of the 3 games for 2 times in the IVR group and will be asked to imagine that they perform the same functions in the IVR games. The motor imagery will be 3 days a week for a total of 6 weeks and 45 minutes per day (including rest periods).
15828607|NCT04215679|Other|Conventional physiotherapy|Individuals in this group will be randomly recruited from hospitalized stroke volunteers. Since these individuals receive routine rehabilitation 5 days a week, they will be evaluated at the beginning and end of 18 sessions over a total period of 6 weeks. Conventional physiotherapy will include normal joint movements, muscle strengthening exercises, balance and mobility exercises, and exercises to improve daily life activity.
15828608|NCT04215653|Drug|Anaprazole Sodium|administered orally once every 30-60 minutes before breakfast for 4 weeks
15828609|NCT04215653|Drug|Rabeprazole|administered orally once every 30-60 minutes before breakfast for 4 weeks
15828610|NCT04215653|Drug|Rabeprazole Placebo|administered orally once every 30-60 minutes before breakfast for 4 weeks
15828611|NCT04215653|Drug|Anaprazole Sodium Placebo|administered orally once every 30-60 minutes before breakfast for 4 weeks
15828612|NCT04215640|Device|Microfidelity (MIFI) catheter|Patients are randomized into the MIFI group and control group. Radiofrequency ablation will target slow pathway for AVNRT or accessory pathway for AVRT. Microfidelity (MIFI) catheter equipped with mini-electrodes will be used for ablation in the MIFI group.
15828613|NCT04215640|Device|Conventional ablation catheter|Patients are randomized into the MIFI group and control group. Radiofrequency ablation will target slow pathway for AVNRT or accessory pathway for AVRT. Blazer II radiofrequency ablation catheter will be used for ablation in the control group.
15828614|NCT04215627|Device|non-invasive monitoring|Comparing the PiCCO monitor to the non-invasive BB-613PW device in hemodynamically unstable critically ill patients in the ICU
15828615|NCT04215614|Drug|Lidocaine and Bupivacaine solution|1:1 ratio 2% lidocaine, and 0.5% bupivacaine
15828616|NCT04215614|Device|Costoclavicular block|Ultrasound-guided costoclavicular brachial plexus block
15828617|NCT04215614|Device|Lateral Sagittal block|Ultrasound-guided lateral sagittal brachial plexus block
15828618|NCT04215588|Device|Hemostasis Management System Plus|Hemostasis Management System Plus (Medtronic, Minneapolis, MN) is a point of care device useful in the management of heparinization during bypass. It estimates the individual heparin dose response and calculates heparin concentration (IU/ml) in whole blood.
15828619|NCT04215588|Device|Activated Coagulation Timer System Plus|The Activated Coagulation Timer System Plus device calculates the Activated Clotting Time (ACT) in seconds.
15828620|NCT04215575|Device|glaucoma implant procedure (Baerveldt)|A 350 mm2 Baerveldt glaucoma implant was placed in the superotemporal quadrant in 25 patients randomized to BGI group. A limbus-based conjunctival flap was dissected, and the implant was sutured to sclera 10 mm posterior to the limbus. A scleral graft was used to cover the limbal portion of the tube, and the conjunctiva was closed.
15828621|NCT04215575|Device|glaucoma implant procedure (Ahmed)|A 184 mm2 Ahmed glaucoma implant was placed in the superotemporal quadrant in 56 patients randomized to AGV group. A fornix-based conjunctival flap was dissected, and the implant was sutured to sclera 10 mm posterior to the limbus. The Ahmed tube left patent and viscoelastic substance injected into anterior chamber. A scleral graft was used to cover the limbal portion of the tube, and the conjunctiva was closed.
15828622|NCT04215562|Combination Product|rehabilitation|electro-therapy, heat therapy, massage and exercise therapy
15828623|NCT04215549|Other|No intervention|cross sectional study，no intervention
15828624|NCT04215536|Drug|Empagliflozin|Empagliflozin dispensing claim is exposure
15828627|NCT04215523|Drug|DPP-4 inhibitor|DPP4 inhibitor dispensing claim is reference
15828628|NCT04215510|Procedure|endonasal endoscopic surgery|143 patients will undergo endonasal endoscopic surgery
15828629|NCT04215510|Radiation|radiation therapy(IMRT)|143 patients will undergo radiation therapy.
15828630|NCT04215497|Other|PSSE|"Physiotherapeutic Scoliosis-Specific Exercises (PSSE) group will receive exercise for 30-40 mins in a day, twice in a week, totally 8 weeks and 16 hours.
~Control group will be taught the basic elements of corrective exercises and want them to do the practising during 8 weeks at home."
15828631|NCT04215484|Diagnostic Test|serum BNP assessment|serum BNP assessment in pregnant women with placenta previa, associated or not to a suspected abnormal placental invasion, compared to a control group
15828632|NCT04215471|Drug|PD-L1 Antibody SHR-1316|Neoadjuvant therapy with immunoreagent (PD-L1 antibody SHR-1316) for resectable oesophageal squamous cell carcinoma
15828633|NCT04215458|Other|sample collection (swap or tape strip)|collection of swap or tape strip to determine yeast colonization in skin
15828634|NCT04215445|Drug|Empagliflozin 25 MG|Tab.empagliflozin 25mg once daily for 28 days
15828635|NCT04215445|Device|OCT-A|Optical coherence tomography angiography (OCT-A) is a non-invasive method to study the microvasculature of the retina and choroid.
15828636|NCT04215432|Device|Gel containing propolis extract, nanovitamin C and nanovitamin E|The patient had to use the gel as a toothpaste and apply it with an interdental brush in mesial and distal aspects of the implant with peri-implant mucositis. during 1 month.
15828637|NCT04215432|Device|Placebo|The patient had to use the gel as a toothpaste and apply it with an interdental brush in mesial and distal aspects of the implant with peri-implant mucositis.
15828638|NCT04215406|Other|The level of air pollution|The intervention measure is the level of air pollution, it is a non-human interventional measure based on the weighted average of various air pollutants monitored by air pollution monitoring stations during different period of pregnancy.
15828639|NCT04215393|Drug|Conbercept eye drop|In the first stage, subjects will be receive Conbercept eye drop. In the second stage,subjests will revceive conbercept eye drop or placebo.
15828640|NCT04215393|Drug|Placebo|In the second stage, subjects will be receive Conbercept eys drop or a placebo.
15828641|NCT04215380|Dietary Supplement|Acacia Senegal extract|Oral Digestion of Gum Arabic dissolved in 200 ml of water to be consumed early morning in daily basis for 12 weeks
15828642|NCT04215380|Dietary Supplement|Pectin|Oral Digestion of Pectin to be consumed early morning in daily basis for 12 weeks
15828643|NCT04215367|Dietary Supplement|High phenolic EVOO intake|During the pilot dietary intervention patients with CLL consumed before their meals, 40 ml/day high phenolic EVOO for 6 months
15828644|NCT04215367|Dietary Supplement|No High phenolic EVOO intake|Medical record of each patient's was followed during 6 month before dietary the intervention
15828645|NCT04215354|Device|Magnetic field|Low pulsed electromagnetic field induced by BEMER machine model type: B.BOX Professional, model NO: 420200, 12-15 Volt, with maximum 300 Watt and average flux density around 35 microtesla- (BEMER Liechtenstein product, USA). Mattress which is flexible, 6 flat coil was used for whole body therapy.
15828646|NCT04215354|Device|Virtual reality|Wii Fit plus machine which required balance board . It is a video game console designed by Nintendo 2009
15828647|NCT04215341|Behavioral|Physiotherapy|A course of breathing retraining delivered by a physiotherapist and practiced by the participant at home.
15828648|NCT04215328|Dietary Supplement|Mixed-Meal|Per 250ml bottle: 220 calories, protein 9g, carbohydrate 33g (15g sugar), fat 6g, sodium 190mg, potassium 390mg; 500mLs by tube daily in 4 doses
15828649|NCT04215328|Dietary Supplement|Electrolyte Solution|Electrolyte Solution 500mLs by tube daily in 4 doses
15828650|NCT04215315|Other|Retrospective observation|Case note and imaging review
15828651|NCT04215302|Device|laryngeal mask|the size of laryngeal mask given to the patient was based on patient's weight measurement
15828652|NCT04215276|Other|Valsalva maneuver|pressure during Valsalva maneuver was measure using sphygmomanometer
15828653|NCT04215276|Other|Control|patient was not given any intervention
15828654|NCT04215263|Other|Questionaire|Patient was assessed using mini international neuropsychiatric interview
15828655|NCT04215250|Other|andropulous method|Counts the CVC depth using specific equation
15828656|NCT04215250|Device|ECG|Using ECG to monitor the insertion of the CVC
15828657|NCT04215237|Drug|Atorvastatin 20 Mg Oral Tablet|Atorvastatin 20mg oral once a day
15828658|NCT04215224|Diagnostic Test|Histopathology images based survival prediction for glioma patients|Histopathology images based survival prediction of glioma patients in the frame of molecular pathology by leveraging AI
15828659|NCT04215211|Diagnostic Test|Survival prediction for glioma patients|Survival prediction of glioma patients in the frame of molecular pathology by leveraging AI
15828660|NCT04215198|Dietary Supplement|Move3™ (NEM® brand eggshell membrane + KD PUR® brand fish oil)|Dietary supplement combination for the support of joint health.
15828661|NCT04215198|Dietary Supplement|Placebo|Placebo
15828662|NCT04215185|Device|CardiacSense1BP|Continuous recording will be performed in parallel using invasive arterial line recording and CardiacSenseBP1 non-invasive recording. The ECG data recorded in the ICU will also be obtained.
15828663|NCT04215172|Drug|Macrolides|administration of azithromycin three times weekly for six months
15828664|NCT04215159|Drug|Trastuzumab biosimilar|1st cycle 8 mg/kg by IV infusion over 90 mins, from 2nd cycle 6mg/kg by IV infusion over 30 mins. every 3weeks.
15828665|NCT04215159|Drug|Gemcitabine Hydrochloride|1000 mg/m2 by IV infusion over 30 minutes on Day 1, Day 8. every 3weeks.
15828666|NCT04215159|Drug|Irinotecan Hydrochloride|100 mg/m2 by IV infusion over 90 minutes on Day 1, Day 8. every 3weeks.
15828667|NCT04215146|Drug|Paclitaxel|Paclitaxel 80 mg/m^2 1-hour IV infusion on days 1, 8, and 15 of a 28-day cycle.
15828668|NCT04215146|Biological|Pelareorep|Pelareorep 4.5 x 10^10 TCID50 1-hour IV infusion days 1, 2, 8, 9, and 15, 16 of a 28-day cycle.
15828669|NCT04215146|Drug|Avelumab|Avelumab 10 mg/kg (not more than 800 mg) 1-hour IV infusion days 3 and 17 of a 28-day cycle.
15828670|NCT04215133|Other|exercise therapy|inspiratory muscle training consists of strengthening exercise with threshold Inspiratory muscle training device and calf muscle training consist of isotonic and isometric strengthening exercise for calf muscle. All groups will receive compression therapy at the same time.
15828673|NCT04215107|Other|Standard breakfast meal|"The first ultrasound will be preformed during fasting. IUGR group will be served a standard breakfast meal, and perform the second ultrasound after 2 hours from the meal.
~The control group will be crossover randomized to meal or prolonged fasting. It will be performed 4 ultrasounds: during fasting and 2 hours after standard breakfast meal. During fasting and during prolonged fasting."
15828674|NCT04215081|Device|Gait training using ExoAtlet exoskeleton|Subjects will learn to use the ExoAtlet II exoskeleton, with the assistance of a trained medical professional, to perform functional activities (including stand-up, sit-down, stepping forward, and walking).
15828675|NCT04215055|Device|vibraject|VibraJect; is a small battery-operated attachment that snaps on to the standard dental syringe. It delivers a high-frequency vibration to the needle which is strong enough for the patient to feel.
15828676|NCT04215042|Drug|sodium chloride infusion|
15828677|NCT04215029|Behavioral|Exercise Intervention|Receive exercise plan
15828678|NCT04215029|Other|Informational Intervention|Receive printed exercise materials
15828679|NCT04215029|Other|Informational Intervention|Receive physical activity and healthy eating information/materials
15828680|NCT04215029|Other|Interview|Participate in interview
15828681|NCT04215029|Other|Nutritional Assessment|Complete nutrition counseling sessions
15828682|NCT04215029|Other|Questionnaire Administration|Ancillary studies
15828683|NCT04215029|Behavioral|Telephone-Based Intervention|Receive coaching calls
15828684|NCT04215016|Biological|Autologous humanized anti-CD19 and anti-CD20 dual specific CAR-T Cells|Humanized anti-CD19 and CD20 bispecific autologous CAR-T cells injection: the first dose is 1.0×106 /kg, the second dose is 3.0×106 /kg, and the third dose is 8.0×106 /kg. Patients will receive lymphodepleting chemotherapy at least 1 week before CAR-T cell infusion.
15828685|NCT04215003|Drug|A|"Paclitaxel: paclitaxel 80 mg/m2 ivgtt d1, d8, d15, 28 days per cycle. Carboplatin: carboplatin AUC=2 ivgtt d1, d8, d15, 28 days per cycle. Herceptin: 4 mg/kg (loading dose 8mg/kg) ivgtt d1,8,15, 22, 28 days per cycle,6 cycles.
~Pertuzumab: 420-mg ( loading dose 840mg) ivgtt d1, 21 days per cycle,6 cycles."
15828686|NCT04215003|Drug|B|Paclitaxel: paclitaxel 80 mg/m2 ivgtt d1, d8, d15, 28 days per cycle. Carboplatin: carboplatin AUC=2 ivgtt d1, d8, d15, 28 days per cycle.
15828687|NCT04215003|Drug|CL1|"Drug:
~SHR6390（CDK4/6 inhibitor）150 mg qd(three week on one week off) Fulvestrant 500mg IM Q4W； Premenopause：Goserelin 3.6mg IM IM Q4W."
15828688|NCT04215003|Drug|CL2|"Drug:
~SHR6390（CDK4/6 inhibitor）150 mg qd(three week on one week off); Alpelisib 300mg PO QD； Premenopause：Goserelin 3.6mg IM IM Q4W."
15828689|NCT04215003|Drug|CLH1|"Drug:
~SHR6390（CDK4/6 inhibitor）150 mg qd(three week on one week off) Fulvestrant 500mg IM Q4W； Herceptin: 4 mg/kg (loading dose 8mg/kg) ivgtt d1,8,15, 22, 28 days per cycle； Pertuzumab: 420-mg ( loading dose 840mg) ivgtt d1, 21 days per cycle； Premenopause：Goserelin 3.6mg IM IM Q4W."
15828690|NCT04215003|Drug|CLH2|"Drug:
~SHR6390（CDK4/6 inhibitor）150 mg qd (three week on one week off) Alpelisib 300mg PO QD； Herceptin: 4 mg/kg (loading dose 8mg/kg) ivgtt d1,8,15, 22, 28 days per cycle； Pertuzumab: 420-mg ( loading dose 840mg) ivgtt d1, 21 days per cycle； Premenopause：Goserelin 3.6mg IM IM Q4W."
15828691|NCT04215003|Drug|CH1|"Drug:
~pyrotinib(EGFR-TKI) 400mg qd； Herceptin: 4 mg/kg (loading dose 8mg/kg) ivgtt d1,8,15, 22, 28 days per cycle； capecitabine 1000mg/m2 bid(d1-d14)"
15828692|NCT04215003|Drug|CH2|"Drug:
~Paclitaxel: paclitaxel 80 mg/m2 ivgtt d1, d8, d15, 28 days per cycle. Carboplatin: carboplatin AUC=2 ivgtt d1, d8, d15, 28 days per cycle.Herceptin: 4 mg/kg (loading dose 8mg/kg) ivgtt d1,8,15, 22, 28 days per cycle； Alpelisib 300mg PO QD； Herceptin: 4 mg/kg (loading dose 8mg/kg) ivgtt d1,8,15, 22, 28 days per cycle； Pertuzumab: 420-mg ( loading dose 840mg) ivgtt d1, 21 days per cycle； Premenopause：Goserelin 3.6mg IM IM Q4W."
15828693|NCT04215003|Drug|CT1|"Drug:
~SHR6390（CDK4/6 inhibitor）150 mg po.qd(three week on one week off) SHR3680（AR inhibitor）240 mg po. qd."
15828694|NCT04214990|Drug|Aspirin 100mg|Daily aspirin 100 mg for 5 years
15828695|NCT04214990|Drug|Placebo oral tablet|Daily placebo for 5 years
15828696|NCT04214977|Procedure|Spinal Anesthesia for Anorectal Surgeries in Prone Position|Spinal anesthesia in sitting position was done under complete aseptic technique through a standard midline approach. One and a half millilitres of 0.5% bupivacaine (7.5 mg) was injected through a 25 Gauge pencil-point needle into the subarachnoid space at L3-L4 or L4-L5 interspace. All patients were kept in a head-up position for 3 minutes. The patient was then asked to turn him- or herself into the prone position on the surgical table with the help of the surgical and anesthetic teams.
15828697|NCT04214977|Procedure|General Anesthesia Using Laryngeal Mask Airway for Anorectal Surgeries in Prone Position|General anesthesia was induced using fentanyl 2 mcg/kg and Propofol 2-3 mg/kg. Any stomach contents were then suctioned through an oro-gastric tube to reduce the risk of regurgitation. Proper (weight-based) classic laryngeal mask airway was then blindly inserted. laryngeal mask airway was then properly fixed to the face and anesthesia was maintained with isoflurane 1-2% in 50% Oxygen/air mixture.
15828698|NCT04214951|Drug|Eltrombopag|Patients will be given eltrombopag 50mg once daily for 6 weeks.
15828699|NCT04214951|Drug|Recombinant human thrombopoietin (rh-TPO)|Patients will be given rh-TPO 300 U/kg once daily for 21 days.
15828700|NCT04214938|Other|Intranasal solutions application were done including one solution for per patient before nasoendoscopy procedure according to randomization|Hypertonic sea water, Vemcaine, Otrivine, and a placebo were applied by intranasal before the nasoendoscopy procedure for improving the field of view of clinician and reducing the patient discomfort.
15828701|NCT04214925|Other|Tai Chi|Home exercises will include warm-up and cool-down exercises, stretching for shoulder, hamstring and erector spinae muscles, strengthening exercises for abdominal and back muscles.
15828702|NCT04214912|Combination Product|Personalized Survivor Care Plan (PSCP)|Based the above literature review and our previous 10 years' efforts in OC patients' distress and care needs survey, we categorize OC patients' distress and needs into 6 major dimensions (1) symptoms management and dysfunction prevention (different kind of symptom, such as swallowing difficulty, eating difficulty, speaking difficulty, difficulty in opening mouth/trismus, shoulder dysfunction, mucositis, pain, fatigue, etc), (2) enhancing physical function (exercise skills, types for major parts of muscle training), (3) Confronting and dealing with psychological distress (fear, anxiety, depression, uncertainty), (4) nutrition assessment and counseling, (5) Social connection and RTW counseling (attitudes and skills for returning to work), and (6) overall needs assessment and supports.
15828703|NCT04214886|Drug|Fludarabine|Fludarabine is an anti-cancer drug acting as an antimetabolite that is used to treat leukemia and lymphoma cancers.
15828704|NCT04214886|Drug|Cyclophosphamide|Cyclophosphamide is is an anti-cancer drug acting as an alkylating agent that is used to treat leukemia and lymphoma cancers.
15828705|NCT04214886|Biological|CD19-CD34 CAR transduced T cells|CD19-CD34 CAR transduced T cells are the subject's own immune cells that target B cell markers on cancer cells.
15828706|NCT04214873|Device|PiQo4 Laser System|PiQo4 Laser System for treatment of POH
15828707|NCT04214860|Drug|APR-246|APR-246 4.5 g/day
15828708|NCT04214860|Drug|Venetoclax|Venetoclax 400 mg once daily
15828709|NCT04214860|Drug|Azacitidine|Subcutaneous injection, or intravenous infusion
15828710|NCT04214847|Procedure|Ahmed Glaucoma Valve surgery|The surgical procedure was identical for both implant types and was performed as described previously.9,14 All surgical procedures were performed under local anesthesia except for children, general anesthesia was used. The valve plate was primed and placed in the superotemporal quadrant after making fornix-based conjunctival flap. The valve plate was secured to sclera with 10-0 nylon sutures 10 mm posterior to the limbus. Before implantation, applying sponges soaked with Mitomycin- c 0.3 cc for three minutes on bare sclera at this quadrant. The tube was placed in the anterior chamber through a 23-gauge needle tract at the limbus. The tube left patent and viscoelastic substance injected into anterior chamber. A donor scleral graft was secured with interrupted 10-0 nylon sutures over the exposed portion of the tube. Conjunctiva was sutured with 10-0 nylon sutures.
15828711|NCT04214834|Drug|Morphine|Rapid-wean: 176 treated Slow-wean: 75 treated
15828712|NCT04214834|Drug|Methadone|Rapid-wean: 176 treated Slow-wean: 75 treated
15828713|NCT04214821|Drug|Levofloxacin Ophthalmic Solution|Levofloxacin hydrate, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily for 3 days pre-operatively and one drop on the day of operation.
15828714|NCT04214821|Drug|Moxifloxacin Ophthalmic Solution|Moxifloxacin hydrochloride, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily for 3 days pre-operatively and one drop on the day of operation.
15828715|NCT04214808|Drug|AD-208|Dutasteride 0.2mg
15828716|NCT04214808|Drug|Avodart Soft Capsule 0.5mg|Dutasteride 0.5mg
15828717|NCT04214795|Other|Observational study. Postnatal variables are recorded|Postnatal evolution is analyzed in both groups
15828718|NCT04214782|Diagnostic Test|Artificial Intelligence Enabled Transvaginal Ultrasound Imaging algorithm|AI Enabled Transvaginal Ultrasound diagnosis for ovarian cancer
15828719|NCT04214769|Diagnostic Test|Audiometry and tympanometry, vHIT, VEMP, ENG|Diagnostic tests
15828720|NCT04214743|Device|Incident dark field videomicroscope from Braedius|It allows to look at conjunctival microcirculation
15828721|NCT04214743|Device|Fundus camera from Optomed|It allows to monitor retinal microvasculature
15828722|NCT04214730|Combination Product|NK combined with Chemotherapy|Patients will receive 4 cycles of NK treatments combined with Chemotherapy within 8 months
15828723|NCT04214730|Drug|Chemotherapy|Patients will only receive Chemotherapy.
15828724|NCT04214717|Combination Product|DC-CIK combined with Chemotherapy|Patients will receive 4 cycles of DC-CIK treatments combined with Chemotherapy within 8 months.
15828725|NCT04214717|Drug|Chemotherapy|Patients will only receive Chemotherapy.
15828726|NCT04214704|Device|Genteel lancing device|Painless lancing device that helps to improve and assess self-monitoring frequency and HbA1c respectively
15828727|NCT04214704|Device|Conventional lancing device|Conventional lancing device
15828728|NCT04214691|Drug|Acetaminophen|Acetaminophen tablet will be administered orally in treatment sequence 1 and 2.
15828729|NCT04214678|Procedure|Underwater clip closure|Closure of post-resection defect with endoscopic clips by underwater technique
15828730|NCT04214678|Procedure|Conventional clip closure|Closure of post-resection defect with endoscopic clip by conventional technique
15828731|NCT04214665|Drug|Alpha Lipoic acid 600 mg HR film coated tablets|
15828732|NCT04214652|Drug|IDP-126 Gel|IDP-126 Gel applied topically to the face once daily for 12 weeks.
15828733|NCT04214652|Drug|IDP-126 Vehicle Gel|IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks.
15828734|NCT04214639|Drug|IDP-126 Gel|IDP-126 Gel applied topically to the face once daily for 12 weeks.
15828735|NCT04214639|Drug|IDP-126 Vehicle Gel|IDP-126 Vehicle Gel applied topically to the face once daily for 12 weeks.
15828736|NCT04214626|Drug|Rituximab|"Induction Chemotherapy: 375mg/m2, Intravenous administration on day 0 of each 3-week cycle until disease progression/stable disease after 2 cycles treatment, partial response after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.
~Maintenance Treatment: Rituximab, 375mg/m2, Intravenous administration on day 0 repeated every 4 weeks until disease progression or unacceptable toxicity develops, up to 2 cycles."
15828737|NCT04214626|Drug|Lenalidomide|"Induction Chemotherapy: 25mg, oral administration on day 1 to 10 of each 3-week cycle until disease progression/stable disease after 2 cycles treatment, partial response after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.
~Maintenance Treatment: 10mg oral administration on day 1 to 21 repeated every 4 weeks until disease progression or unacceptable toxicity develops, up to 12 cycles."
15828738|NCT04214626|Drug|Cyclophosphamide|Induction Chemotherapy: 750mg/m2, Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease after 2 cycles treatment, partial response after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.
15828739|NCT04214626|Drug|Epirubicin|Induction Chemotherapy: 70mg/m2, Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease after 2 cycles treatment, partial response after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.
15828740|NCT04214626|Drug|Vincristine|Induction Chemotherapy: 1.4mg/m2 (Max: 2mg), Intravenous administration on day 1 of each 3-week cycle until disease progression/stable disease after 2 cycles treatment, partial response after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.
15828741|NCT04214626|Drug|Prednisone|Induction Chemotherapy: 100mg, oral administration on day 1 to 5 of each 3-week cycle until disease progression/stable disease after 2 cycles treatment, partial response after 4 cycles treatment or unacceptable toxicity develops, up to 6 cycles.
15828856|NCT04213716|Combination Product|conventional calcium hydroxide|1ml of distilled water mixed with 100 mg of calcium hydroxide powder and used as intracanal medication after root canal retreatment
15828742|NCT04214626|Drug|Methotrexate|Induction Chemotherapy: 3mg/m2, Intravenous administration on day 3 of each 3-week cycle until disease progression/stable disease after 2 cycles treatment, partial response after 4 cycles treatment or unacceptable toxicity develops, from 2 to 5 cycles for patients with high recurrence risk of the central nervous system.
15828743|NCT04214613|Procedure|non-cardiac non-neurologic surgery|non-cardiac non-neurologic surgery
15828744|NCT04214600|Behavioral|Cognitive Behavioral Therapy (CBT)|"Patients in the CBT intervention group will receive four educational sessions for 30-45 minutes on one to one basis every two weeks during patients' regular follow up visits. The visits will be scheduled depending on the patient's availability. The sessions will be delivered by a trained physician. The sessions will include:
~Session 1: Dealing with thoughts of sadness and depression Session 2: Dealing with thoughts of anxiety and stress Session 3: Dealing with anger Session 4: Enhancement of coping and problem-solving skills"
15828745|NCT04214587|Diagnostic Test|tissue and blood sampling|only diagnostics will be peformed
15828746|NCT04214574|Device|Parasagittal oblique technique (Ultrasound)|the probe will be placed in a parasagittal plane to identify the articular processes then the sacrum will be identified. The probe will be moved cephalad in the parasagittal axis until the identification of the target lumbar interspaces L2-L3, L3-L4 or L4-L5. Once the appropriate lumbar interspace is identified, the probe will be tilted 45 degree towards the midline into a parasagittal oblique view. The needle will be inserted in plane from the caudal end of the ultrasound transducer with its tip directed towards the interlaminar space under real-time in-plane US guidance.
15828747|NCT04214574|Device|Paramedian tranverse technique (Ultrasound)|the transducer will be applied in the parasagittal plane, and after identification of the intervertebral level, the probe will be rotated 90 degrees into a transverse orientation and centered on the neuraxial midline in a way to align the beam with the interspinous and interlaminar space and thus to get a paramedian transverse interlaminar view. The needle will be inserted in plane from the lateral end of the ultrasound transducer with its tip directed towards the medial border of the articular process.
15828748|NCT04214561|Diagnostic Test|Polysomnography|Each of the patients will undergo polysomnography
15828749|NCT04214548|Other|No Intervention|There is no intervention for this study
15828750|NCT04214535|Device|Tritanium C Anterior Cervical Cage|50 subjects undergoing anterior cervical discectomy and fusion surgery using the Tritanium C Anterior Cage for one or two-levels
15828751|NCT04214522|Behavioral|Determine what the imagery levels are|Determine the motor imagery: kinesthetic and visual imagery
15828752|NCT04214496|Device|Sedline|Intraoperative EEG monitorization
15828753|NCT04214483|Other|No intervention|There is no intervention for this study.
15828754|NCT04214470|Other|No intervention|There is no intervention for this study
15828755|NCT04214457|Procedure|Biopsy and peripheral blood collection|"After obtaining informed consent, the samples (tumor tissue and peripheral blood) will be collected at the time of surgery, which the patient had already planned by medical indication according to the usual clinical practice. Part of the sample will be sent to histopathology for gold standard diagnosis while the rest of the sample will be sent to Igenomix for molecular analysis.
~If samples are available from patients who underwent surgery prior to the study, after they sign the Informed Consent, the samples will be sent to Igenomix for molecular analysis and the results obtained by histopathology will be collected from the patient's medical record."
15828756|NCT04214444|Biological|Anti-pneumococcal vaccination with prime-boost strategy in patients with diffuse large B cell lymphoma|The investigators aim to describe efficiency and tolerability of prime-boost vaccination against pneumococcus in patients with Diffuse large B-cell Lymphoma. The investigators search to evaluate immunogenicity of prime-boost depending on the time of prevenar administration (before or after immunochemotherapy) and on the dose (single or double dose).
15828757|NCT04214431|Behavioral|Mindfulness-Based Childbirth Education|8-week mindfulness-based childbirth education
15828761|NCT04214405|Procedure|fixation of tripodal zygomatic fractures|One point versus two point fixation of tripodal zygomatic fractures
15828762|NCT04214392|Biological|Chlorotoxin (EQ)-CD28-CD3zeta-CD19t-expressing CAR T-lymphocytes|Given via dual delivery
15828763|NCT04214379|Procedure|Ptosis surgery|Frontalis sling surgery using pose-up and Wright's fascia-lata needle
15828764|NCT04214366|Radiation|Carbon ion irradiation|22 x 3 Gy(RBE) Carbon Ions
15828765|NCT04214366|Radiation|Bimodal irradiation|25 x 2 Gy photon IMRT + 8 x 3 Gy(RBE) Carbon ion boost
15828766|NCT04214353|Diagnostic Test|68Ga-PSMA-PET/CT|All participants in the study will be injected with 2.0 MBq/kg 68Ga-PSMA for PET/CT imaging, both pre- and post ADT.
15828767|NCT04214353|Diagnostic Test|18FDG-PET/CT|All participants in the study will be injected with 2.1 MBq/kg 18FDG for PET/CT imaging, both pre- and post ADT.
15828768|NCT04214340|Other|evaluation of practices|Study of the management and follow-up of patients presenting with appendicitis in France.
15828769|NCT04214327|Behavioral|Strengthening Families Program Online eLearning Game|Families (parent/caregiver and children) are to play-test a highly interactive online gamified version of the Strengthening Families Program called SFP Online, with 10 lessons that utilize three 10-minute mini-sessions and games that teach parents evidence-based parenting and family relationship skills and teach youth social, life, and alcohol and drug refusal skills. Skills are reinforced through gaming. Game points are achieved by right answers to self-correcting mini-quizzes for low-stakes failure and through actual reported home practice of the skills. The SFP parenting skills have been shown to reduce risk factors and increase protective factors that prevent youth substance abuse.
15828770|NCT04214327|Behavioral|SFP Home-use DVD|Family views an 11-session SFP video series online or at home using a DVD that contains the same program and lesson content as the online condition; however, the lesson material is more static without the interaction required in the gamified version of SFP Online.
15828857|NCT04213703|Other|No intervention|There is no intervention for this study
15828858|NCT04213690|Other|No Intervention|There is no intervention for this study
15829054|NCT04212013|Other|Placebo|Placebo capsules will be similarly dosed at 4 capsules daily.
15828771|NCT04214327|Behavioral|Wait-Listed Control|Families receive no active intervention for 22 weeks; however, during this wait time, participants receive weekly email reminders that contain riddles and puzzles for youth and parents receive nutritional information and food preparation recipes. Following conclusion of the initial trial the wait-listed control sites are then administered the 10-session SFP Online intervention
15828772|NCT04214314|Behavioral|NeuronUp APT attentional program|NeuronUp APT attentional program consists of 4 types of attention with 20 activities each and 5 different levels of difficulty per activity. These 20 activities will be divided into two blocks (block A or block B) of 10 activities each and then, randomly, participants will be administered one block or another. The administration of the entire program is approximately one month and a half or 2 months per patient, with sessions of one hour, 3 times per week.
15828773|NCT04214301|Drug|BLI800|BLI800 Bowel Preparation
15828774|NCT04214288|Drug|AZD9833|Dosage formulation: AZD9833 tablets will be administered orally.
15828775|NCT04214288|Drug|Fulvestrant|Dosage formulation: Fulvestrant will be administered via intramuscular (IM) injection.
15828776|NCT04214275|Other|pulmonary rehabilitation|Simple breathing techniques, secretion-removal techniques, airway-cleaning techniques, mobilization techniques and use of an incentive spirometer
15828781|NCT04214249|Drug|Cytarabine|Given via continuous IV infusion
15828782|NCT04214249|Drug|Daunorubicin Hydrochloride|Given IV
15828783|NCT04214249|Procedure|Hematopoietic Cell Transplantation|Undergo HSCT
15828784|NCT04214249|Drug|Idarubicin Hydrochloride|Given IV
15828785|NCT04214249|Biological|Pembrolizumab|Given IV
15828786|NCT04214236|Device|ciNPT group|Closed-incision negative pressure therapy (ciNPT) will be applied for 7 day using continuous suction at 125 mmHg. To deliver ciNPT we will use a commercially available, FDA-approved device, used according to the manufacturer' indications (PREVENA™ Incision Management System (KCI, San Antonio, Texas, USA). After the first 7 post-operative days, subjects will discontinue the ciNPT and follow a standard wound care protocol.
15828787|NCT04214236|Other|Control group|Standard non-adherent surgical dressing (Vaseline petrolatum gauze) will be used for management of incisional wounds in the control group. Dressing changes will be performed per standard wound care protocol.
15828788|NCT04214223|Other|Pre-Anesthesic Consultation|Classical Pre-Anesthesic Consultation with an anesthesist of the maternity hospital of Nancy (France)
15828789|NCT04214223|Other|Pre-Anesthesic Numerical Evaluation|Home-based Pre-Anesthesic Numerical Evaluation with the aid of a questionnaire, achieved with a computer, digital tablet or smartphone, on a secured platform.
15828790|NCT04214210|Other|Adapted Family Gene Toolkit|Five web-based modules designed to increase knowledge of cancer genetics (Module 1); provide decisional support for genetic testing (Module 2); increase active coping to common challenges faced by HBOC families (Module 3); provide a five-steps, skills-building communication training (Module 4); increase knowledge about management of hereditary cancer risk based on the most updated recommendations from the National Comprehensive Cancer Network (Module 5).
15828791|NCT04214210|Other|Targeted intervention|The comparison website will provide targeted information about HBOC and enable sharing genetic test results.The Korean team will define the contents of the comparison website that will mimic the structure and function of a website already available in the US. The Korean team will create a translation process protocol, and share this guide for further translations from English into Korean and three Swiss national languages. The tailored and the targeted platform will be technically implemented in the same system, to track access and usage of the platform and provide a user-friendly experience.
15828792|NCT04214197|Drug|Crisaborole 2% Top Oint|Crisaborole is a low molecular weight benzoxaborole PDE-4 inhibitor for the treatment of mild-to-moderate atopic dermatitis in adults and children 2 years and above. Crisaborole ointment 2% is topically applied as a thin layer twice daily for 4 weeks to all AD lesions.
15828793|NCT04214184|Behavioral|Increased sleep duration|Participants will increase their nightly time in bed by 2 hours per night for 4 weeks to target the recommended 7 hours of sleep per night.
15828794|NCT04214171|Diagnostic Test|Gait and muscle strength will be assessed|The extensor moment of the hip during gait and evaluation of the muscular strength of the hip will be evaluated
15828795|NCT04214158|Other|Assessment|Assessment
15828796|NCT04214145|Drug|Phenylephrine|"Continuous infusion of Phenylenphrine 250 μg/mL (=Phenylephrine 10mg * 5@ + D5W 200 mL) if mean BP < 60mmHg.
~Initial rate: 0.42 μg/kg/min (=0.1 mL/kg/hr)
~Increment by 0.21 μg/kg/min (=0.05 mL/kg/hr) if mean BP < 60mmHg after 5 minutes
~Maximum rate: 3.33 μg/kg/min (=0.8 mL/kg/hr)"
15828797|NCT04214145|Drug|Norepinephrine|"Continuous infusion of Norepienphrine 20 μg/mL (=NE 4mg * 1@ + D5W 200 mL) if mean BP < 60mmHg.
~Initial rate: 0.03 μg/kg/min (=0.1 mL/kg/hr)
~Increment by 0.015 μg/kg/min (=0.05 mL/kg/hr) if mean BP < 60mmHg after 5 minutes
~Maximum rate: 0.24 μg/kg/min (=0.8 mL/kg/hr)"
15828798|NCT04214145|Drug|Vasopressin|"Continuous infusion of Vasopressin 0.1 u/mL (=Vasopressin 20u * 1@ + D5W 200 mL) if mean BP < 60mmHg.
~Initial rate: 0.01 u/kg/hr (=0.1 mL/kg/hr)
~Increment by 0.005 u/kg/hr (=0.05 mL/kg/hr) if mean BP < 60mmHg after 5 minutes
~Maximum rate: 0.08 u/kg/hr (=0.8 mL/kg/hr)"
15828799|NCT04214132|Other|Virtual Counselling Application using Artificial Intelligence|Intervention comprises of four Virtual Patients scenarios that aimed to improve nursing undergraduates communication skills in a clinical setting. These scenarios are based on authentic clinical cases (adapted from the real-life clinical case studies) focusing mainly on the communication aspects. Scenarios included 1) a middle-aged pregnant woman in her third trimester experiencing pain, 2) a middle-aged lorry driver who self-admitted to the hospital due to relapse of depressive symptoms, 3) changing a bloody dressing of a middle-aged male patient who had an operation 3 days ago, and 4) communicating with a fellow stressed student during their final preregistration clinical posting period.
15828800|NCT04214106|Drug|intravenous Thiamine|patients who received Thiamine,100-500 mg/day for at least one day
15828859|NCT04213677|Drug|Dapagliflozin|Participants will receive dapagliflozin 10mg po qd. Additionally, participants will receive lifestyle modification and nutrition education.
15829055|NCT04212000|Drug|Levoketoconazole|Levoketoconazole tablet
15829056|NCT04212000|Drug|Ketoconazole|Ketoconazole tablet
15828801|NCT04214093|Drug|AZD0466|"In Arm A, AZD0466 will initially be administered IV over one hour, once weekly to the first cohort of patients. Subsequent cohorts of patients within Arm A are planned to receive sequentially higher doses.
~In Arm B, intrapatient dose ramp-ups will involve beginning at a specified starting dose and weekly increasing the dose to a maximum target dose for the cohort."
15828802|NCT04214080|Other|Neurodevelopmental treatment (NDT)|NDT is a holistic and interdisciplinary clinical practice model informed by current and evolving research that emphasizes individualized therapeutic handling based on movement analysis for habilitation and rehabilitation of individuals with neurological pathophysiology.
15828803|NCT04214080|Other|Feeding and oral-motor intervention strategies|Feeding and oral-motor intervention strategies have been developed to address difficulties with sucking, chewing, swallowing, and improve oral-motor skills.
15828804|NCT04214080|Other|Neck and trunk stabilization exercises|Trunk control affects head control. After gaining head control, it causes jaw stability and oral motor control (tongue control and lip closure). All of these affect communication and quality of life.
15828810|NCT04214054|Other|Moldable self-hardening biphasic calcium phosphate graft|Incision was performed in the canine area then a full thickness mucoperiosteal flap was elevated and exposure of the lateral aspect of the maxillary sinus. Osteotomy of the buccal window was performed using the piezosurgery device followed by meticulous dissection of the sinus membrane. Drilling the site were implants were to be placed, guided by the preformed surgical stent. Implants of appropriate size were torqued to engage the apical aspect of the implant recipient site. The sinus was augmented with moldable self-hardening biphasic calcium phosphate. Repositioning and suturing of the flap using 3-0 black silk suture material.
15828811|NCT04214054|Procedure|No graft material placed - Blood Clot only|A pyramidal full thickness mucoperiosteal flap was performed distal to the canine area with a crestal incision located palatally in the edentulous area and vertical extension of the incision to the buccal vestibule using Bard Parker blade number 15. The flap was reflected exposing the alveolar bone. Lateral window was performed and the sinus membrane was elevated using piezo surgery. Drilling at the sites where implants were to be placed was done using Neobiotech implant drilling Kit. Implants. Implants were placed in a self-tapping fashion using a torque wrench. Flaps were replaced back and sutured using 3-0 black silk suture material.
15828812|NCT04214041|Other|Autologous fat grafting|A fat graft will be aspirated from the abdomen under local anaesthesia and processed using the Microfat grafting technique. Afterwards the fat graft will be injected in the previously created pouch at the recipient site. Then the pouch will be closed using interrupted sutures 5-0 vicryl.
15828813|NCT04214041|Other|Sub-epithelial connective tissue graft|A subepithelial connective tissue graft of a size that corresponds to that of the defect will be harvested from the palate using the trap door technique. The donor site will be closed using cross horizontal sling sutures and interrupted sutures 4-0 vicryl. Subsequently, the graft will be inserted in the previously created pouch at the recipient site and secured to the flap using vicryl sutures 5-0. Then the pouch will be closed using interrupted sutures.
15828814|NCT04214015|Other|No intervention|There is no intervention for this study
15828815|NCT04213989|Device|Flexitouch Plus and Conservative Care|A segmental, programmable, gradient advanced pneumatic compression device. The system consists of a controller unit and garments, and provides in-home manual lymphatic drainage therapy in the legs for approximately 1 hour daily. Conservative care may include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
15828816|NCT04213989|Other|Conservative Care|May include 30-40 mmHg graduated compression up to waist, dietary counseling, exercise, and/or referral for CDT.
15828817|NCT04213976|Procedure|Ileostomy|Use of an ileostomy to decompress the proximal bowel, perfored either as a conventional loop ileostomy or as described by Santulli et al. or by Bishop and Koop.
15828818|NCT04213950|Other|Rabies PEP quality improvement bundle|The rabies PEP quality improvement bundle consists of (1) electronic health record enhancements to support rabies PEP treatment selection, administration, and discharge process; (2) education to ED staff on rabies PEP; and (3) education to patients on rabies PEP and follow-up care.
15828819|NCT04213937|Drug|nab-paclitaxel|Drug: nab-paclitaxel 125mg/m2, i.v. d1, d8, Repeated every 3 weeks for 4-6 cycles.
15828820|NCT04213937|Drug|Topotecan|Drug: Topotecan 1.25mg/m2/d, i.v, 1hour, d1-d5, Repeated every 3 weeks for 4-6 cycles.
15828821|NCT04213924|Drug|Bupivacaine HCl 0.5 % in 10 ml and 2 % lidocaine in 10 ml|Erector spinae plane block, 30 min before the ESWL procedure.
15828822|NCT04213924|Drug|5 % Lidocaine Topical Gel and 800 mg ibuprofen intravenously|5 % Lidocaine Topical Gel and 800 mg ibuprofen intravenously, 30 min before the ESWL procedure.
15828823|NCT04213911|Radiation|low-dose chest CT scan|The low-dose chest CT scan is now commonly used as a quick, painless, and non-invasive approach to screen for lung cancer. The radiation exposure from one low-dose CT scan of the chest (1.5 mSv) is comparable to 6 months of natural background radiation for a person living in the US.
15828824|NCT04213911|Device|insertion of esophageal balloon|The esophageal catheter is a flexible thin plastic tube with an air-filled balloon at the distal end. The tube will be placed through the nasopharynx after local anesthesia.
15828825|NCT04213898|Drug|SHR-1210+Albumin-bound paclitaxel + epirubicin|Neoadjuvant therapy：SHR-1210, 200mg,iv, q3w, for 6 cycles; Albumin-bound paclitaxel: 125 mg/m2, iv, d1, d8, and d15, 21 days as a cycle, for 6 cycles; Epirubicin: 75mg / m2, iv, d1, 21 days as a cycle, for 6 cycles; The surgery was performed 3-4 weeks after the completion of neoadjuvant chemotherapy.
15828826|NCT04213885|Combination Product|PXL 330 Platinum device/Riboflavin|30mW, 5 sec, 5 sec off, 10 minutes of illumination
15828827|NCT04213872|Behavioral|Meditative Movement|The Meditative Movement program is a blend of meditation and exercise based on Tai Chi and Qigong.
15828860|NCT04213677|Drug|Placebo|Participants will receive placebo po qd. Additionally, participants will receive lifestyle modification and nutrition education.
15828894|NCT04213352|Other|Wrist Splint|Neutral position and volar supported wrist orthosis which limits the flexion and deviation while allowing pronation, supination, and extension of the wrist.
15828828|NCT04213859|Behavioral|VRET - Virtual Reality Exposure Therapy|VRET will include 4 weekly 1-hour sessions over the course of 4 weeks. The treatment protocol is based on the Virtual Reality (VR) treatment manual guidelines (Rothbaum & Hodges, 1997,1999) and includes psychoeducation, anxiety management training, cognitive restructuring and exposure. The first therapy session focuses on creating an individually-tailored conceptualization and treatment plan. Following this process, participant and therapist conduct a short introductory VR flight exposure simulation to familiarize the participant with the VRET apparatus. The VRET apparatus is an advanced, large-scale VR system that allows maximal immersion within the virtual environment. The second, third and fourth sessions include psychoeducation, relaxation training, cognitive restructuring and individually-tailored VR exposures (the therapist can manipulate the turbulence level and other flight-related variables to fit participants' fears and current progress).
15828829|NCT04213846|Behavioral|Experimental: Mobile Alcohol Expectancy Challenge (mAEC)|Participants randomized to the mAEC condition will receive daily intervention messages two times a day for three weeks in the mobile app. The intervention uses participants' own daily responses to personalize messages, when appropriate, that challenges their personal expectations of alcohol's positive effects on mood, social facilitation, and tension reduction, as well as aggression and risk-taking. The intervention messages also focus on intentions to drink and pharmacologically-delayed negative effects. Intervention Messages in general will include feedback based on selected assessment items, weekly summaries generated from the daily assessments, general psycho-educational messages and videos about alcohol, and a toolbox with supplemental information (e.g., personal BAC calculators, resources).
15828830|NCT04213833|Drug|Propofol Injection [Diprivan]|patients will be sedated with 50 mg propofol(10 mg/ml) given slowly intravenously over 1 min
15828831|NCT04213833|Drug|Dexmedetomidine [Precedex]|patients will received 0.5 mcg/ kg dexmedetomidine intravenously followed by syringe containing 50 mg propofol(10 mg/ml).
15828832|NCT04213833|Drug|Palatable Lidocaine Topical Gel|15 g of palatable lidocaine gel will be gradually applied 3-5 min before the endoscopy at three consecutive 30-s intervals to the base of the tongue, the palate and the peritonsillar areas and the patients will be informed to spread it within their mouth with their tongue and swallow it later to cover the oropharynx and esophagus. Patients will be asked to register the onset of numbness, then patient will receive syringe containing 50 mg propofol (10 mg/ml) intravenously as a sedation.
15828833|NCT04213820|Device|Transcranial magnetic stimulation|TMS (theta burst) will be administered consisting of bursts containing 3 pulses at 50 Hz and an intensity of 80% motor threshold repeated at 200 ms intervals (i.e., at 5 Hz) and a 10 s between burst triplet interval for a total for 190 s (600 pulses). The intervention will be given daily 5 times/week during 4 weeks.
15828834|NCT04213820|Behavioral|Body Image Intervention|Body image interventions delivered directly after TMS will include body exercises that target disturbed body image and psychoeducation about the body. Together with a therapist the participants with anorexia nervosa will explore and estimate their body size through feedback.
15828835|NCT04213820|Behavioral|Treatment as usual|Treatment as usual at the eating disorder unit, Child and adolescent psychiatric clinic and Psychiatric clinic is delivered during 4 weeks
15828836|NCT04213807|Biological|MAA868 Cohort 1|Subcutaneous injection: low dose
15828837|NCT04213807|Biological|MAA868 Cohort 2|Subcutaneous injection: high dose
15828838|NCT04213807|Biological|MAA868 Cohort 3|Subcutaneous injection: Dose to be determined
15828839|NCT04213807|Other|Placebo|Subcutaneous injection: Placebo
15828840|NCT04213794|Drug|Cisplatin|Undergo HIPEC with doxorubicin and cisplatin
15828841|NCT04213794|Procedure|Cytoreductive Surgery|Undergo cytoreduction
15828842|NCT04213794|Drug|Doxorubicin|Undergo HIPEC with doxorubicin and cisplatin
15828843|NCT04213794|Drug|Hyperthermic Intraperitoneal Chemotherapy|Undergo HIPEC with doxorubicin and cisplatin
15828844|NCT04213794|Drug|Sodium Thiosulfate|Given IV
15828845|NCT04213781|Device|HappyMed Video Glasses|HappyMed allows the immersion of patients in films, cartoons or concerts.
15828846|NCT04213781|Drug|Propofol|The dosage is modified according to the Dixon's up-and-down method (using 0.5 µg/ml as a step size). The first patient in each group will start at a dose 3 µg/ml propofol. If patient manifests discomfort then the next patient will receive an increment of 0.5 µg/ml propofol, if patient is comfortable, then the next patient received a decrement of 0.5 µg/ml propofol.
15828847|NCT04213781|Drug|Sufentanil|0.1 µg/kg
15828848|NCT04213768|Procedure|Lateral rectus plication|The technique is the same as resection up to the muscle suturing, in the next step, the sutures is passed through 2 scleral bites at 1 mm anterior to the muscle insertion, then the muscle is folded anteriorly by Stevens muscle hook during tightening and fixing the sutures. At the end, conjunctiva is repaired by Vicryl 8-0.
15828849|NCT04213768|Procedure|Lateral rectus Resection|Following conjunctiva and tendon capsule incision, lateral rectus is hooked and dissected from its surrounding tissues. Then, the muscle is sutured according to the amount of supposed resection from lateral rectus insertion by Vicryl 6-0 (polyglation 910, coated Vicryl®, Ethicon, Blue Ash, OH). Afterwards, the muscle is cut at 1mm anterior to these sutures and the residual muscle is re-sutured to the sclera at its primary insertion. Finally the conjunctiva is repaired using Vicryl 8-0.
15828850|NCT04213755|Diagnostic Test|ROTEM|ROTEM including INTEM, EXTEM, APTEM, and FIBTEM
15828851|NCT04213742|Other|Thanksgiving diary intervention|Record gratitude.
15828852|NCT04213729|Behavioral|Diet Counseling|Standard of care diet counseling provided at clinic visit 1.
15828853|NCT04213729|Other|CD LFD|Daily breakfast, lunch, dinner and snacks LFD catered meals. Meals will have approximately 20% calories from fat, a goal ratio close to 1:1 omega-6/omega-3 fatty acids, and approximately 25-35 grams of fiber per day.
15828854|NCT04213729|Behavioral|Dyadic Psychological Support (DPS)|The dyadic psychosocial support (DPS) intervention will be provided for a total of 12 weeks. The 12-week DPS intervention consists of eight sessions (main sessions) and two booster sessions. The intervention will incorporate psychoeducational components that combine didactic and behavioral regulatory procedures to promote healthy diet behavior for self-determined reasons.
15828855|NCT04213716|Combination Product|silver nano particulate solution mixed with calcium hydroxide powder|1ml of nanosilver solution 30ppm concentration mixed with 100 mg of calcium hydroxide powder used as intracanal medication
15828893|NCT04213365|Other|Cognitive stimulation sessions coupled with Adapted Physical Activity sessions.|12 weeks of cognitive stimulation sessions coupled with APA (Adapted Physical Activity) sessions.
15828861|NCT04213664|Other|prognosis|cancer and overall survival cancer specific survival cancer and recurrence-free survival cancer and disease-free survival lymphocyte to monocyte ratio in non-metastatic renal cancer and progression-free survival
15828862|NCT04213651|Other|No intervention|There is no intervention for this study
15828863|NCT04213638|Other|Single Microneedle Radiofrequency therapy|Subjects are treated with three consecutive sessions of Single Microneedle Radiofrequency therapy at 2-week intervals, with a follow-up visit 12 weeks after the final third treatment. Each treatment session took approximately 30-60 minutes.
15828864|NCT04213638|Other|Photodynamic therapy|Subjects are treated with three consecutive sessions of Photodynamic therapy at 2-week intervals, with a follow-up visit 12 weeks after the final third treatment.
15828865|NCT04213625|Other|Surgeon Personal Background|"Experimental group will receive an information sheet with their surgeon's educational and personal background.
~Personal Background
~Favorite outdoor activity/form of exercise
~Favorite hobby
~Family information (children, pets)
~Single sentence about how the clinician conceptualizes excellent patient care"
15828866|NCT04213612|Drug|pegylated liposomal doxorubicin, cyclophosphamide, vincristine,|PLD 40mg/m2 ; PLD 50mg/m2 ; PLD 60mg/m2 ; Maximum tolerated dose； Dose-limiting toxicity
15828867|NCT04213599|Diagnostic Test|Coronary intervention|Patients with STEMI undergo coronary intervention
15828868|NCT04213586|Dietary Supplement|Whey protein supplementation|35 g of whey protein (7 d/wk) during a 10-wk resistance training program (3 d/wk; 3 sets of 8-12 repetitions with an interval of 1-2 minutes between sets and exercises) involving the leg press, leg extension, and arm flexion exercises. The load will be adjusted weekly.
15828869|NCT04213586|Dietary Supplement|Collagen supplementation|35 g of collagen (7 d/wk) + 2 g of leucine during a 10-wk resistance training program (3 d/wk; 3 sets of 8-12 repetitions with an interval of 1-2 minutes between sets and exercises) involving the leg press, leg extension, and arm flexion exercises. The load will be adjusted weekly.
15828870|NCT04213573|Drug|silver diamine fluoride|38% silver diamine fluoride liquid will be applied with a brush
15828871|NCT04213573|Drug|MI Varnish|topical fluoride varnish with calcium and phosphate
15828872|NCT04213560|Device|weighted waist-hooping|weighted waist-hooping
15828873|NCT04213547|Behavioral|Loss frame sleep extension intervention|Aim 2 will be an interventional study design utilizing Fitbit and text messaging to perform a loss-framed incentive intervention designed to motivate participants to increase their sleep duration. Glycemic control will be measured via laboratory testing of hemoglobin A1c and Libre continuous glucose monitoring (CGM) for 2 weeks pre- and post-intervention.
15828874|NCT04213521|Other|Multisensory balance exercise|Multisensory balance training describes a balance exercise incorporating individual sensory manipulation of vision, vestibular, proprioception and sensory integration.
15828875|NCT04213521|Other|Conventional balance exercise|such as static and dynamic standing balance without altered sensory inputs.
15828876|NCT04213508|Drug|Isotonic Saline ( 0.9% Sodium Chloride Saline)|0.9% Sodium Chloride (NaCl) saline will be used as nasal irrigation for two groups. (first groups 2 times per day and second group 5 times per day ). Each time, amount of 50 ml of saline will be used in each nostril ( 100 ml for both nostrils per time) . So, in total 500 ml of 0.9% Sodium Chloride (NaCl) saline will be used daily for 1 month .
15828877|NCT04213508|Drug|Hypertonic Saline ( 3% Sodium Chloride Saline)|3% Sodium Chloride (NaCl) saline will be used as nasal irrigation for two groups. (first groups 2 times per day and second group 5 times per day ). Each time, amount of 50 ml of saline will be used in each nostril ( 100 ml for both nostrils per time). So, in total 200 ml of 3% Sodium Chloride (NaCl) saline will be used daily for 1 month .
15828878|NCT04213495|Other|Anesthesia|Patients undergoing anesthesia from the cooperating Anesthesia center
15828879|NCT04213482|Radiation|Panoramic Radiography|Diagnostic Panoramic Dental Radiographs were taken.
15828880|NCT04213469|Biological|CD19-Specific Chimeric Antigen Receptor T cells with PD1 knockout|Autologous CD4+ and CD8+ T cells by gene-editing with both knockout of PD1 and also integration of anti-CD19 ScFv
15828881|NCT04213456|Dietary Supplement|Nutritional Sport Formula|Powder added to water,high protein and multi vitamins and minerals
15828882|NCT04213456|Dietary Supplement|Placebo|Low caloric formula (Powder added to water), without added vitamins and minerals.
15828883|NCT04213443|Other|Analysis of a patient registry|Analysis of a patient registry.
15828884|NCT04213430|Other|diagnostic|Training dataset was used to train the deep learning model, which was validated and tested by other two datasets.
15828885|NCT04213417|Other|Bobath therapy and Matrix Rhythm Therapy|MRT application that was applied to the study group in addition to the BC was applied to the affected side of the body and lower extremity for 60 minutes in each session.The treatment was started from the thoracic region and a treatment direction was toward the lower extremity in the affected side.During the MRT procedure, the patient's active participation was ensured and the treatment was combined with the exercises.The patients were informed about MRT verbally and in writing before the application. Participants were treated 3 days a week for 4 weeks for a total of 12 sessions.
15828886|NCT04213417|Other|Bobath therapy|Both groups were treated with the BC as a neurodevelopmental therapy. Considering individual requirements and wishes of the patient, an exercise program that supports active participation of the person was established.Each treatment session was performed for 60 minutes.The treatment program that was established appropriately according to the patient contained weight transfer to the affected side in different positions,approximation to increase proprioceptive input, providing sensorial input to the sole of the foot using materials such as sensory ball,foot-ankle mobilization,functional reach activities, forward-side step, gait, and balance activities. Participants in both groups were treated 3 days a week for 4 weeks for a total of 12 sessions.
15828887|NCT04213404|Drug|Ribociclib|Ribociclib 400mg, 600mg, or 200mg oral daily, D1-D21, 28 days a cycle
15828888|NCT04213404|Drug|Spartalizumab|Spartalizumab 400mg ivdrip on D1, 28 days a cycle.
15828889|NCT04213391|Dietary Supplement|sulforaphane|Sulforaphane take 2550mg once a day.
15828890|NCT04213391|Dietary Supplement|Placebo|Placebo take 2550mg once a day.
15828891|NCT04213378|Device|Paclitaxel eluting PTCA balloon|Treatment of coronary in-stent re-stenosis with paclitaxel eluting PTCA balloon
15828892|NCT04213378|Device|SeQuent® Please paclitaxel eluting balloon|Treatment of coronary in-stent re-stenosis with SeQuent® Please paclitaxel eluting balloon
15828959|NCT04212832|Drug|Bupivacaine|0.5 ml/kg %0.25 bupivacaine
15828895|NCT04213352|Other|Rigid Taping|Rigid taping in the neutral position will be performed to allow pronation, supination, and extension of the wrist while limiting the flexion and deviation.
15828896|NCT04213339|Behavioral|Kegel Exercises|"Kegel exercise group will get exercise within duration of 3 to 6 weeks based on age factor. Kegel exercise can be performed at any time and at any place without any restrictions.
~following steps will be followed by kegel exercises group members:
~Tighten and hold pelvic floor muscles for five seconds (count 1 one thousand, 2 one thousand, 3 one thousand, 4 one thousand, 5 one thousand).
~Relax pelvic muscles and perform 10 to 20 Kegel exercises three to four times each day.
~Squeeze the muscles in anus like holding a bowel movement focus penile area
~Relax the pelvic floor muscles after each attempt.
~Repeat this exercise 10 to 20 times.
~While performing Kegel exercises:
~Do not hold the breath. Do not push down. Squeeze the muscles together tightly and imagine, trying to lift this muscle up. Do not tighten the muscles in the stomach, buttocks, or thighs.
~While the control group did not participate in any kegel exercises"
15828897|NCT04213313|Drug|Treatment of bacterial keratitis|0.3% Levofloxacin Eye Drops or 0.3% Tobramycin Eye Drops QID
15828898|NCT04213313|Drug|Treatment of fungal keratitis|1% Fluconazole Eye Drops or 0.25% Amphotericin B Eye Drops QID
15828899|NCT04213313|Drug|Treatment of viral keratitis|0.1% Acyclovir eye drops QID ，Ganciclovir gel QN，Famiclovir tablets 0.25g TID
15828900|NCT04213313|Diagnostic Test|corneal scraping|culture and sensitivity of corneal ulcerated infiltrating edge tissue
15828901|NCT04213313|Other|Sequencing|polymerase chain reaction with sequence specific primers(PCR-SSP) and Sanger sequencing
15828902|NCT04213300|Other|Low carbohydrate diet|"Study duration: 13 weeks (run in phase = 1 week; low carbohydrate diet phase = 12 weeks).
~Each participant will be provided with an individualised meal plans to meet their energy needs as per the Schofield formula and a macronutrient distribution of 20% for carbohydrate, 25% for protein and 55% for fat.
~Participants will self-report quality of life using a validated diabetes specific quality of life questionnaire for Australian adults and HbA1c (pre and post intervention phase of 13 weeks duration) ."
15828903|NCT04213287|Drug|Dexketoprofen Trometamol|Drug: Dexketoprofen Trometamol oral tablet
15828904|NCT04213287|Other|spinal anesthesia|Drug: heavy bupivacaine 2,5 ml 0,5%
15828905|NCT04213287|Other|IPACK|Drug: bupivacaine 20 ml 0,025%
15828906|NCT04213287|Other|PAI|Drug: bupivacaine 30 ml 0,025%
15828907|NCT04213287|Other|Adductor canal block|Drug: bupivacaine 20 ml 0,025%
15828908|NCT04213274|Biological|80 mg RPH-104|solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL glass vial
15828909|NCT04213274|Drug|Placebo|Normal Saline (0.9% Sodium Chloride solution for Injection), 2 mL in the 4 mL-glass vial
15828910|NCT04213261|Biological|FCX-007 (dabocemagene autoficel; see below for FCX-007 description)|FCX-007 is comprised of fibroblasts isolated from the subject's skin biopsies which are genetically corrected with the full length COL7A1 gene encoding for type VII collagen.
15828911|NCT04213248|Drug|Umbilical Mesenchymal Stem Cells derived Exosomes|Participants will receive artificial tears for 2 weeks to get the normalized baseline, followed by UMSC-exo 10ug/drop, four times a day for 14 days. The follow-up visit will be 12 weeks.
15828912|NCT04213235|Behavioral|Physical activity|The participants will receive the written exercise guidebook and a counselling by kinesiologist. Moreover, they will be instructed how to increase their physical activity level.
15828913|NCT04213222|Drug|Bevacizumab|bevacizumab combined with chemotherapy
15828914|NCT04213209|Drug|Brentuximab Vedotin (Genetical Recombination)|Brentuximab Vedotin Intravenous Infusion
15828915|NCT04213196|Drug|HSK21542|Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
15828916|NCT04213196|Drug|HSK21542|Intravenous injection 0.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
15828917|NCT04213196|Drug|HSK21542|Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
15828918|NCT04213196|Drug|HSK21542|Intravenous injection 1 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.
15828919|NCT04213196|Drug|HSK21542|Intravenous injection 0.75 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
15828920|NCT04213196|Drug|HSK21542|Intravenous injection 1.5 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
15828921|NCT04213196|Drug|HSK21542|Intravenous injection 2.25 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
15828922|NCT04213196|Drug|HSK21542|Intravenous injection 3.375 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 15 min.
15828923|NCT04213196|Drug|HSK21542|Intravenous injection 0.2 μg/kg solution (active or placebo, 0.5-1h after standard meal). Complete infusion within 2 min.
15828924|NCT04213183|Diagnostic Test|Hepatobiliary Disorders|The training dataset was used to train the deep learning model, which was validated and tested by the other two datasets.
15828925|NCT04213170|Drug|sintilimab|Sintilimab 200mg d1 and Bevacizumab 15mg/kg d1 q21d
15828926|NCT04213144|Device|Magdent Cap MED|Magdent is intended to be used for accelaration of soft tissue and bone healing
15828927|NCT04213144|Device|Sham MED|Sham MED is intended to be used for soft tissue healing
15828928|NCT04213131|Other|Stem cell transplantation|The eligible patients with chronic spinal cord injury included in this study will receive intravenous, lumbar, and local administration of hUC-MSCs/hUCB-MSCs and routine rehabilitation treatment. At 1, 3, 6 and 12 months after treatment, patients will be followed up and evaluated.
15828929|NCT04213118|Drug|Anlotinib Hydrochloride|Anlotinib 12mg QD PO d1-14, 21 days per cycle.
15828930|NCT04213118|Procedure|TACE|TACE first, followed by anlotinib within day4（+/-1days）
15828931|NCT04213105|Drug|QL1206|subcutaneous injection of 60 mg (1ml) only once,on the first day.
15828932|NCT04213105|Drug|Prolia®|subcutaneous injection of 60 mg (1ml)only once,on the first day
15828933|NCT04213092|Procedure|ERCP+LC|Patients in this group underwent a single setting ERCP and Laparoscopic cholecystectomy.
15828934|NCT04213092|Procedure|OC+CBD|Patients in this group underwent a single setting open cholecystectomy and open CBD exploration.
15828960|NCT04212832|Other|Standard pain|Standard pain follow up and monitorization
15828935|NCT04213079|Device|re-adaptation of the vestibulo-ocular reflex|The VOR will be readapted by activating velocity storage with full-field optokinetic motion at 5°/s in a set direction while the head is oscillated with a set frequency and direction. The readaptation training will be conducted in repeated modules, each lasting for 1-5 min. The expected duration of daily sessions varies from 30 to 90 min. A day's session will be terminated if patient no longer feel symptoms of MdDS.
15828936|NCT04213079|Device|Habituation of velocity storage of the vestibulo-ocular reflex|The central (velocity storage) time constant will be reduced by inducing cancellation of two velocity storage-mediated responses: OKN and the VOR. Sinusoidal rotation at 0.017 Hz (1 revolution/min) in darkness advances the slow phase eye velocity of the VOR by 32º. In contrast, the OKN at this frequency has no phase advancement. Thus, to counteract the VOR by OKN, the optokinetic stimulus should be set to 32º phase advance the out of phased head rotation stimulus. Since the conflict stimulus is expected to be overwhelming to patients at higher chair velocities, subjects will be first trained with a 10°/s stimulus. In a previous study, no complaints were reported when subjects were tested at such low velocities. Preliminary testing show signs of symptom improvement when the peak velocity reached 30°/s to 40°/s.
15828937|NCT04213066|Device|Portable tablet|Each training session was limited to 15 minutes a day, 5 days a week. The entire training period was 6 months.
15828938|NCT04213053|Procedure|strabismus surgery|Lees screen before and after concomitant strabismus surgery
15828939|NCT04213040|Diagnostic Test|Serum levels of Procalcitonin, C-reactive protein, lactate|"Serum PCT, CRP, and lactate values were collected postoperatively every day starting on postoperative 12 hours, postoperative days 1 through 5.
~After the operation, all postoperative complications were recorded during the first seven days period.
~The relations between diagnostic tests and postoperative complications are sought by the use of the statistical analysis methods."
15828940|NCT04213027|Procedure|native tissue repair procedures with conventional surgical instruments|Sacrospinous ligament fixation (SSLF): treatment for apical prolapse with vaginal fornix suspended to sacrospinous ligament; Ischial spinous fascia fixation (ISFF): treatment for apical prolapse with vaginal fornix suspended to ischial spinous fascia (ISFF).
15828941|NCT04213014|Behavioral|Guys/Girls Opt for Activities for Life (GOAL)|The 4 month (16-wk) GOAL intervention has 3 components: (1) After-school GOAL Club: 26 events (2 d/wk; 120 min/event/day; 13 wks due to no club during 3 school break wks) for boys and girls to engage in physical activity and healthy eating and cooking activities; (2) Three parent-adolescent meetings (group meetings at each school): to empower parents to assist adolescents with physical activity and healthy eating and cooking; and (3) GOAL social networking website: private website for parents to share with each other how they helped their adolescent increase physical activity and diet quality during a prior wk.
15828942|NCT04213001|Diagnostic Test|ultrasonographic measurement|ultrasonographic measurement- Subcutaneous ultrasound echogenicity (SEG) and Skin and subcutaneous thickness measurement
15828943|NCT04212988|Procedure|Increase the SCO2 value|The interwention process will be started once the SCO2 value below ideal levels (80% of the basic level or 50% of absolute value), by adjusting the position of extracorporeal circulation arteriovenous catheter, balancing arterial pressure, increasing oxygen supply , adjusting pump speed ,etc.
15828944|NCT04212975|Other|joint lavage with dextrose|joint lavage with dextrose
15828945|NCT04212962|Behavioral|Transitional care model (TCM)|Patient education about post-discharge self-care and medications, arrangement of needed social services, coordination of information from medical providers interacting with patient
15828946|NCT04212962|Behavioral|Usual care|usual hospital discharge and post-discharge care
15828947|NCT04212949|Device|Repetitive transcranial magnetic stimulation (rTMS)|Stimulation will be performed from the contralateral M1 cortex of the painful side. Each stimulation session will consist of 1500 pulses (30 trains of 5 seconds each, with an inter-train interval of 25 seconds) delivered at a frequency of 10 Hz. The stimulation intensity will be set at 80% of the resting motor threshold.
15828948|NCT04212949|Drug|Transforaminal epidural steroid injection|"An epidural steroid injection under guidance of fluoroscopy is used to reduce inflammation at a lumbar spinal nerve root(s).
~The following drugs will be used for this procedure: 80mg/2ml triamcinolone acetonide (sinakort-A) and 1 mL 0.5% bupivacaine (marcaine)"
15828949|NCT04212936|Procedure|Intraabdominal pressure|Limited intraabdominal pressure during laparoscopic cholecystectomy between 8 and 10 mmHg.
15828950|NCT04212923|Behavioral|Medical Dashboard based self-management intervention|Before the start of the intervention, chronic kidney disease patients and care providers will receive a face-to-face training session on the use of Medical Dashboard. To avoid contamination, Medical Dashboard will only be made accessible for participants in the intervention group via a secure password-protected registration process.
15828951|NCT04212897|Other|Music Therapy|"Participants in the intervention arm will be asked to practice a rhythmic auditory synchronous finger tapping intervention task at home for a total of 25 minutes split between two ten-minute sets with a five-minute break between the sets every day for 8-weeks. During training sessions participants must listen to the instrumental of a pre-selected well-known Chinese melody, Moonlight over the Lotus Pond by Phoenix Legend, whose melody duration is 259s. This song was selected for its strong beat and familiarity to the participants. Participants must follow the beats of the melody and tap their right index finger simultaneously to the beats. A visual cue will be displayed to indicate the beats, identical to the one in the assessment. The training session will be conducted once daily after patients have taken their medication. Participants' primary caretaker will be asked to monitor and record completion of sessions."
15828952|NCT04212871|Other|watch food video 1|A 2 minutes video, with food content. The first study used a ramen mukbang here, the second study used a hotpot mukbang.
15828953|NCT04212871|Other|watch food video 2|A 2 minutes video, with food content (different content from video 1). The first study used a donut mukbang here, the second study used a hotpot cooking show here.
15828954|NCT04212871|Other|watch a non-food content video|a 2 minutes video without food content. The first study used a documentary introducing the forbidden city, the second study used a documentary introducing Cornell University.
15828955|NCT04212858|Genetic|zinc-finger protein 217 gene|search for zinc-finger protein 217 gene in myeloma patients
15828956|NCT04212845|Drug|Bupivacaine;Dexamethasone Solution for Injection|8 mg Dexamethasone and %0.25 bupivacaine
15828957|NCT04212845|Device|Fluoroscopy|Fluoroscopy-guided transforaminal injection
15828958|NCT04212845|Device|Ultrasound|Ultrasound-guided erector spinae plane block
15828961|NCT04212819|Other|Before Erythrocyte Suspension (ES)|ES transfusion needs of the patients were determined according to clinical signs and symptoms. Vital signs were closely monitored and recorded before, during and after transfusion. Infusion was performed slowly for the first 15 minutes in terms of allergic reaction, and then the transfusion rate was adjusted according to the patient's clinic.
15828962|NCT04212819|Other|After Erythrocyte Suspension (ES)|Venous blood samples were obtained from patients who needed ES transfusion before transfusion. Control venous blood samples were obtained from the patients who did not develop any complications for 24 hours after starting of the transfusion and became hemodynamically stable.
15828963|NCT04212793|Drug|Bevacizumab-IRDye800CW|Intravenous administration of 4.5, 10 or 25 mg of Bevacizumab-IRDye800CW prior to endoscopic transsphenoidal surgery
15828964|NCT04212793|Device|Molecular Fluorescence Endoscopy platform|A flexible fluorescence fiber-bundle is attached to a fluorescence camera platform to enable the detection of fluorescence signals. The fluorescence fiber-probe is inserted through the standard working channel of the Surgvision explorer endoscope. During surgery, three imaging moments are defined in which the fluorescence molecular endoscopy system will detect the fluorescent signal
15828965|NCT04212780|Device|Medtronic Summit Rechargable (RC)+S|Dual channel closed-loop pulse generator with connection to both new DBS leads for deep stimulation of VIM vs VO
15828966|NCT04212780|Procedure|ipsilateral thalamic (VIM+VO) DBS|Implantation of two new ipsilateral thalamic (VIM+VO) DBS
15828967|NCT04212780|Procedure|standard ET DBS|Single Lead VIM
15828968|NCT04212780|Procedure|ipsilateral VO|second lead in the ipsilateral VO
15828969|NCT04212767|Procedure|Alveolar socket preservation with Platelet-rich fibrin|The sockets of the test group will be filled with two platelet-rich fibrin membranes followed by suture
15828970|NCT04212754|Other|Exposure: human development index of country|Primary comparison: Between country groups defined by human development index.
15828971|NCT04212741|Dietary Supplement|A+ HA(tm)|oral solution of hyaluronic acid mixture
15828972|NCT04212741|Dietary Supplement|Placebo|oral solution with no-active ingredients
15828973|NCT04212728|Biological|Auotologous AMSCs plus autologous PRP|150 mL subcutaneous abdominal adipose tissue will be harvested via liposuction . AMSCs will be isolated and cultured from adipose tissue. Before injection, 30 mL of blood will be collected from each patient to produce 3ml PRP by cenrifugation.Cultured AMSCs will be collected and suspended by 3ml autologous PRP.
15828974|NCT04212728|Biological|Auotologous PRP|30 mL of blood will be collected from each patient to produce 3ml PRP by cenrifugation.
15828975|NCT04212715|Radiation|Pelvic SABR with intra-prostatic SABR|SABR 25Gy / 5 fractions to pelvis; 35Gy / 5 fractions to prostate; up to 50Gy / 5 fractions to MR nodule
15828976|NCT04212702|Drug|Hormonal therapy-based treatments|Hormonal therapy-based treatments, ex. HT single agent, HT plus other targeted therapy, HT plus everolimus, HT plus metronomic oral chemotherapy or oral chemotherapy only
15828977|NCT04212689|Device|Game Based Virtual Reality Exercises|A game-based virtual reality device named USE-IT will be added to the rehabilitation program. USE-IT is a technological rehabilitation system designed by the Department of Physiotherapy and Rehabilitation at Hacettepe University. It is a smart gaming device which has been used in patients who suffer from movement loss in their upper extremities due to various neurological and orthopedic reasons.
15828978|NCT04212689|Other|Conventional Physiotherapy and Rehabilitation|The conventional physiotherapy and rehabilitation program includes stretching exercises, neurodevelopmental approaches, static positioning, strengthening exercises, Transcutaneous Electrical Nerve Stimulation (TENS), hydrotherapy, cryotherapy.
15828979|NCT04212676|Other|Body Awareness Therapy|The BAT for the participants was based on the works of Roxendal and Dropsy. Activities include relaxation exercises, breathing exercises, floor exercises for trunk and pelvic movements, weight transfer using extremities and proprioceptive movements. Movements will be made in various positions to determine the centerline of the body. All exercises will be started in the supine position to maximize proprioceptive motion feedback and minimize energy requirements during tasks. Movements will be taught in a series of lessons over a period of 8 weeks with advance advancement of selected movements depending on participant comfort.
15828980|NCT04212676|Other|Pulmonary Rehabilitation|Diaphragmatic breathing exercise Thoracic expansion exercises (Chest breathing and bilateral segmental breathing exercises) Inductive spirometry (Triflo®) exercise Cough development techniques
15828981|NCT04212663|Procedure|The tendon release of musculi tibialis posterior|To release the tendon of musculi tibialis posterior.
15828982|NCT04212663|Procedure|Anterior tibial tendon transfer(TATT)|To transfer the the tendon of anterior tibial from the navicular to the third cuneiform.
15828983|NCT04212663|Procedure|Achilles tendon lengthing|To lengthen the achilles tendon by using two incisions.
15828984|NCT04212663|Procedure|Fascial release|To cut off the metatarsal fascia in the middle part.
15828985|NCT04212650|Drug|Losartan|Losartan will be administered to improve the quality of hip cartilage repair following arthroscopic microfracture. Losartan is a known anti-fibrotic agent via blocking of TGF-B1.
15828986|NCT04212650|Other|Placebo|Appearance-matched microcrystalline cellulose placebo
15828987|NCT04212637|Other|MRI|Examine BOLD activity in relation to eye movements measures
15828988|NCT04212624|Other|Human retinal pigment epithelial (HuRPE) cell injection|Human retinal pigment epithelial cell injection Dosage form and specifications: injection; 600,000 cells / branch (200μl), 1 million cells / branch (200μl), 2 million cells / branch (200μl) Transportation and storage: sealed, stored at 2-8 ° C, valid for 6 hours
15828989|NCT04212611|Drug|INFRA ORBITAL BLOCK|Bilateral infra orbital blocks is performed using 2-3 mL of 0.375% levobupivacaine (group L) or ropivacaine (group R).
15828990|NCT04212598|Drug|Sintilimab|Patients who completed concurrent chemoradiotherapy standard dose would received the Sintilimab as a consolidate therapy for one year.
15828991|NCT04212585|Diagnostic Test|Serology test|"Serology for Helicobacter pylori (immunoglobulin G for all sites, immunoglobulin M optional, immunoglobulin A optional) will be collected from all participants. 90 samples (immunoglobulin G, immunoglobulin M and immunoglobulin A) at least needed from each site.
~Stool antigen for Helicobacter pylori"
15828992|NCT04212559|Other|Received negative pressure ventilation|Patients who received a negative pressure during inspiratory phase.
15829050|NCT04212039|Drug|Bupivacaine|0.5 ml/kg %0.25 bupivacaine
15829093|NCT04211753|Device|Mobile app|Medical device for crisis intervention
15828993|NCT04212546|Other|Synbiotic test drink|In a healthy male population, participants consumed a synbiotic test drink containing 200 mL milk + 16 g inulin + Lactobacillus casei431 [>106cfu/mL] per day for 21 days with their habitual diet.
15828994|NCT04212546|Other|Control drink|In a healthy male population, participants consumed a synbiotic test drink containing 200 mL milk + 16 g maltodextrin per day for 21 days with their habitual diet.
15828995|NCT04212533|Dietary Supplement|Vitamin D|comparison between pre- and postoperative calcium and vitamin d level after vit d and calcium supplementation
15828996|NCT04212533|Dietary Supplement|rice starch tablets|rice starch tablets as placebo
15828997|NCT04212520|Other|No intervention|No intervention
15828998|NCT04212507|Diagnostic Test|The serum level of Claudin-3 and intestinal Fatty acid binding protein|The serum level of Claudin-3 and intestinal Fatty acid-binding protein between patients with psoriasis and controls Understanding the interplay between microbiota, gut barrier and inflammation may contribute to the development of new methods of preventing onset or exacerbations of psoriasis and new therapeutic approach for psoriasis.
15828999|NCT04212494|Procedure|Thrombus aspiration|Percutaneous Coronary Intervention with manual aspiration thrombectomy
15829000|NCT04212494|Procedure|Thrombus aspiration|Percutaneous Coronary Intervention without manual aspiration thrombectomy
15829001|NCT04212481|Procedure|uniport video-assisted thoracoscopic surgery|video-assisted thoracoscopic surgery for NSCLC using single port or two ports or three ports
15829002|NCT04212481|Procedure|two ports video-assisted thoracoscopic surgery|video-assisted thoracoscopic surgery for NSCLC using two ports
15829003|NCT04212481|Procedure|three ports video-assisted thoracoscopic surgery|video-assisted thoracoscopic surgery for NSCLC using three ports
15829004|NCT04212468|Other|no intervention|no intervention
15829005|NCT04212455|Other|Non-interventional study|This is an observational, non-interventional study
15829006|NCT04212442|Behavioral|Independent Living Program for Affordable Housing.|"Two-month program intended to increase physical activity and function, including the following 4 steps:
~Environmental and Policy Assessments: Nurse facilitator works with the affordable housing staff to identify and recommend feasible interventions to alter the environment, policy, and procedures to optimize resident function and physical activity.
~Education: Nurse educates residents and study partners in the principles of the Independent Living Program, using established materials and adult learning techniques.
~Establishing Resident Goals: The nurse completes Capability Assessment Forms and helps resident set goals to increase function and physical activity.
~The nurse helps to motivate and mentor residents and study partners to achieve and maintain their goals, using evidence-based approaches."
15829007|NCT04212429|Drug|Levofloxacin Ophthalmic Product|Levofloxacin hydrate, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily for 3 days pre-operatively and one drop on the day of operation.
15829008|NCT04212429|Drug|Moxifloxacin Ophthalmic Solution|Moxifloxacin hydrochloride, an aqueous ophthalmic solution, to be given one drop at a time, 4 times daily for 3 days pre-operatively and one drop on the day of operation.
15829009|NCT04212416|Drug|Leflunomide|Given PO
15829010|NCT04212403|Drug|Levofloxacin|The control group receives AMP.
15829011|NCT04212377|Biological|Dendritic Cells for endometrial cancer|Our study population consists of 8 mEC patients who receive carboplatin / paclitaxel chemotherapy in a weekly schedule on weeks 1, 2, 3 and weeks 5,6 and 7. In week 8, myeloid and plasmacytoid DC (nDC) are loaded with tumor lysate and MUC1 and survivin PepTivators, injected intranodally. An extensive immuno-motoring will be performed on all patients. Patients who show stable disease, partial response, or full response continue with extended three-week chemotherapy regimens with intranodal injections of nDC at weeks 17, 20, and 23.
15829012|NCT04212364|Behavioral|Peer Education|In this intervention, people who use opiates will be trained to be peer educators.
15829013|NCT04212364|Drug|Narcan Nasal Product|All study participants will be trained in how to use nasal Narcan and they will receive a nasal Narcan kit.
15829014|NCT04212351|Genetic|Frameshift Array blood sample test|Patient blood test samples will be collected and evaluated for frameshift peptide mutations.
15829015|NCT04212338|Other|Before intravitreal injection music intervention|The patients in the Before-IVTI group listened to music for a period of 15 minutes 30 minutes before the injection.
15829016|NCT04212338|Other|during intravitreal injection music intervention|The patients in the During-IVTI group listened to music during the injection (approximately 5 minutes).
15829017|NCT04212325|Procedure|Group C (Continuous sciatic nerve block)|Patients randomized to this group will receive a sciatic nerve block with the catheter tip insertion at the popliteal location 1-3 cm cephalad to the sciatic bifurcation. After Catheter placement outcome measures will be assessed.
15829018|NCT04212325|Procedure|Group S (sciatic nerve block)|Patients randomized to this group will receive a sciatic nerve block at the popliteal location 1-3 cm cephalad to the sciatic bifurcation. After single injection sciatic nerve block, outcome measures will be assessed.
15829019|NCT04212299|Device|Northwestern University Flexible Sub-Ischial Suction Socket (NU-FlexSIS)|"The sub-ischial socket includes a firm, compressive, preferably cylindrical, fabric-covered silicone liner, a flexible inner socket, and a shorter rigid outer socket. The socket has proximal trim lines that do not impinge on the pelvis; they terminate distal to the ischial tuberosity and greater trochanter. For the NU-FlexSIS Socket, passive suction suspension is achieved using a one way valve and a liner with an internal seal.
~Since the prosthetic socket is a custom-made device, it is considered Class I exempt by the Food and Drug Administration (FDA)."
15829020|NCT04212286|Diagnostic Test|Diagnostic CEUS and EOB-MRI|Undergo Sonovue-CEUS and EOB-MRI
15829021|NCT04212273|Diagnostic Test|Diagnostic Sonazoid-CEUS and EOB-MRI|Undergo Sonazoid-CEUS and EOB-MRI
15829022|NCT04212260|Behavioral|Oropharyngeal exercises|Oro-pharyngeal exercises that improve oro-pharyngeal and tongue strength. Instructions will be delivered via a tablet-based app.
15829023|NCT04212260|Behavioral|Sham control|Simple mouth movements that have no impact of oro-pharyngeal strength. Instructions will be delivered via a tablet-based app.
15829051|NCT04212026|Drug|Nivolumab|The patients start treatment with nivolumab on day 1 after IRE and will be given nivolumab at a flat dose of 240 mg every 2 weeks (q2wk) for 5 cycles until Week 8.
15829052|NCT04212013|Drug|Ibrutinib|Ibrutinib capsules (140 mg each) will be dosed at 560 mg once daily on a 28-day cycle on a continuous basis.
15829053|NCT04212013|Drug|Rituximab|Will receive rituximab: 375 mg/m^2 on days 1, 8, 15 and 22 of cycle 1
15829024|NCT04212247|Behavioral|Well-Being Therapy|Well-Being Therapy (WBT) is a short-term psychotherapeutic strategy, that emphasizes self-observation with the use of a structured diary, interaction between patients and therapists and homework. WBT was based on the model of psychological well-being that was originally developed by Jahoda in 1958 and further refined by Ryff in 2014. The standard number of sessions is 8. The initial phase is concerned with self-observation of psychological well-being. Then, the patient is encouraged to identify thoughts, beliefs, and behaviors leading to premature interruption of wellbeing. The final part involves cognitive restructuring of dysfunctional dimensions of psychological well-being and meeting the challenge that optimal experiences may entail.
15829025|NCT04212247|Behavioral|Control condition|The control condition will include 8 sessions that will inform participants about well-being and lifestyles which can influence it. They will be articulated as follows. Session 1: illustrating the concept of lifestyle and well-being. Session 2 and session 3: illustrating healthy eating and steps to healthy eating. Session 4: illustrating physical exercise and how it promotes health. Session 5: illustrating smoking and tobacco and how they can damage health. Session 6: illustrating alcohol and how it can damage health. Session 7: illustrating drug misuse and how it can damage health. Session 8: illustrating sexual health. No access to specific WBT ingredients will be allowed.
15829026|NCT04212234|Device|ultrasound propagation velocities, ultrasound fetal quality|"Obese pregnant women will be included before the second trimester fetal ultrasound examination.
~Women will be allocated to one intervention group or to the control group. In the intervention group, the ultrasonographer will be able to use several ultrasound propagation velocities to perform the exam.
~In the control group, exam will be performed using the conventional ultrasound velocity.
~An exam will be considered to be complete if all the images recommended by national guideline are acquired. If ultrasound images are missing, other ultrasound exams may be performed until completeness is reached.
~The protocol will be applied for the second and the third fetal ultrasound examination which are recommended by national guideline.
~All scans will be evaluated by two independent experts who do not have performed any of the exams. They will evaluate the completeness of each exam. Each scan will be quoted using the quality score proposed by Salomon et al."
15829027|NCT04212221|Drug|MGD013 monotherapy|MGD013 monotherapy will start from Phase I dose escalation first, starting dose will be 120mg Q2W, the dose level may escalate sequentially following traditional 3+3 dose escalation scheme (120mg, 240mg, 400mg, 600mg) to determine the RP2D(recommended phase II dose) of MGD013 monotherapy. Then Phase II dose expansion study will initiate, patients will receive the fixed dose of MGD013 monotherapy with RP2D determined in Phase I study.
15829028|NCT04212221|Drug|MGD013 in combination with Brivanib Alaninate|After determining the RP2D of MGD013 monotherapy, MGD013 at the fixed dose will be combined with Brivanib Alaninate. Dose escalation study of the combination therapy in Phase I will adopt traditional 3+3 dose escalation scheme; the dosage of Brivanib will start from 200 mg QD, and may escalate to 400 mg QD, 600 mg QD and a maximum of 800 mg QD to to determine the RP2D of MGD013 in combination with Brivanib Alaninate. Then Phase II dose expansion study will initiate, patients will receive the fixed dose of MGD013 and Brivanib Alaninate combination therapy with RP2D determined in Phase I study.
15829029|NCT04212208|Device|IV cannulation|IV cannulation in the preoperative period
15829030|NCT04212195|Genetic|Next generation sequencing|Saliva samples
15829031|NCT04212195|Diagnostic Test|Imaging and fluid biomarkers|Magnetic resonance imaging of the brain and urine, blood and cerebrospinal fluid sampling
15829032|NCT04212182|Device|HFNC|HFNC provides warmed and humidified gas administered through slightly enlarged nasal prongs.
15829033|NCT04212182|Device|NPPV|NPPV is the standard therapy for ventilatory failure in AECOPD.
15829034|NCT04212169|Drug|MEDI3506|multiple doses
15829035|NCT04212169|Drug|Placebo|multiple doses
15829036|NCT04212143|Other|there is no intervention|There is no intervention in this study. It is observational only.
15829037|NCT04212130|Other|BCA method for assessing environmental cleanliness|"Evaluating the effectiveness and usability of BCA method which is a new approach in evaluating the effectiveness of environmental cleanliness in intensive care units.
~In this study, fluorecan labeling, microbiological sampling and BCA methods will be compared in order to evaluate the effectiveness and usability of BCA method"
15829038|NCT04212117|Other|The Patient Activated Learning System (PALS)|Randomization into PALS arm.
15829039|NCT04212117|Other|WebMD|Randomization into WebMD arm.
15829040|NCT04212104|Other|watch a mukbang|watch the dim sum mukbang
15829041|NCT04212104|Other|watch a non-food video|watch the Big Bang Theory video
15829042|NCT04212091|Biological|PGT121.414.LS|Administered via IV infusion or SC infusion, depending on the arm
15829043|NCT04212091|Biological|VRC07-523LS|Administered via IV infusion or SC infusion, depending on the arm
15829044|NCT04212078|Drug|Levofloxacin Ophthalmic|0.1ml which has 0.5 mg levofloxacin will be injected via intracameral into the anterior chamber through the side port wound using a tuberculin syringe in a 27 gauge cannula.
15829045|NCT04212078|Drug|Cefuroxime|The vial contains 750 mg of cefuroxime powder is diluted with 7.5 ml of Balanced Salt Solution (BSS). 1 ml of the solution will be withdrawn and added with 9 ml of BSS. Then, 0.1 ml of solution which is equivalent to 1 mg of cefuroxime will be aspirated and kept a side. The dissolution of the antibiotic is confirmed by naked eye. Then the antibiotic of 0.1 ml will be given as intracameral to patient using a tuberculin syringe in a 27 gauge cannula at side port wound at the end of surgery.
15829046|NCT04212065|Drug|buprenorphine|To improve compliance with medication assisted therapy, decrease relapse and neonatal abstinence syndrome, we propose a randomized control trial of long acting subcutaneous buprenorphine compared to short acting sublingual buprenorphine/naloxone administration in pregnant and lactating women.
15829047|NCT04212052|Radiation|split-course radiotherapy|Patients are irradiation at a palliative dose at the initial course: 30Gy/6f to PTV-GTV. The disease is re-evaluated one month after the end of the initial course using CT. The patient who achieved a partial remission according to the RECIST criteria and had a recovery of lung function should get the additional boost. At the second course, the tumor is repositioned and scanned. The residual tumor was then treated with the second course of radiotherapy. A dose of 40Gy/8f is delivered to the residue tumor.
15829048|NCT04212052|Drug|concurrent chemotherapy|Concurrent chemotherapy consists of weekly nab-paclitaxel(50mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration, or nab-paclitaxel(30mg/㎡) and nedaplatin(10mg/㎡) twice every week.
15829049|NCT04212039|Drug|Saline Solution|0.5 ml/kg saline
15829057|NCT04211987|Procedure|fast track care protocol|fast track care consists in educational preoperative preparation for patients, particular strategies for controlling pain and bleeding and intensive early rehabilitation protocol.
15829058|NCT04211987|Procedure|standard care protocol|standard care protocol consists in the same surgical intervention without educational preoperative preparation for patients and intensive early rehabilitation protocol.
15829059|NCT04211974|Diagnostic Test|whole-exome sequencing|"Fresh frozen or formalin-fixed, paraffin-embedded samples were obtained from patients following resection along with matching peripheral blood samples.
~whole-exome sequencing will be performed to identify mutations in tumor tissue and matching blood"
15829060|NCT04211961|Drug|Scopolamine|The treatment group will receive a 100ml infusion of Scopolamine ( dose 4μg/kg) at 4 visits during the study
15829061|NCT04211961|Other|Placebo|The placebo group will receive a 100ml infusion of saline at 4 visits during the study
15829062|NCT04211948|Procedure|robotic surgery|Pancreatectomy with robotic assisted system
15829063|NCT04211948|Procedure|open surgery|Traditional open pancreatectomy
15829064|NCT04211935|Device|Use of PCA|A commercially available PCA pump will be connected to the patient's intravenous line at the end of the MIRPE operation.
15829065|NCT04211935|Device|Use of ESB for postoperative pain control after MIRPE|Pediatric anesthesiologists will place ESB at the time of the MIRPE operation if study participants are randomized into this group.
15829066|NCT04211935|Device|Use of INC for postoperative pain control after MIRPE|Pediatric surgeons will perform INC during the MIRPE operation if they are randomized to this group.
15829067|NCT04211922|Drug|Alkotinib Capsules|Alkotinib 400mg QD
15829070|NCT04211896|Drug|Anlotinib|Anlotinib will be given at a dose of 12mg once daily on days 1-14 of a 21-day cycle.
15829071|NCT04211896|Drug|Nivolumab|Nivolumab will be given at a dose of 240 mg every 2 weeks (Odd Cycles: Days 1 and 15 and Even Cycles Day 8) per 21 day Cycle.
15829072|NCT04211883|Behavioral|ACTIVE intervention|The Project ACTIVE intervention was adapted to suit workflow demands of our busy inner-city clinic: (1) identify patients who could most benefit from improvements in adherence to evidence-based preventive care, (2) use a validated mathematical model to quantify and rank the estimated amount of health benefit that would arise from improved adherence to each USPSTF preventive care guideline, (3) communicate this information in a manner informed by risk communication studies relevant to patients from disparate cultural groups and with low literacy and numeracy, (4) engage the patient in a shared decision making process in which the patient identified which preventive health goals aimed to achieve, and (5) set particular action steps for the next visit that were congruent with these goals .
15829073|NCT04211870|Radiation|Low-level laser therapy|Sessions will be held twice a week for six weeks (total: 12 session). A potentiometer will be used to measure the mean power of the equipment and therapeutic dose, ensuring safety to the participant and operator. Laser will be administered at a wavelength of 786.94 nm using an energy density of 2 J/cm², intensity of 1.675 mW/cm² and power of 70 mW (0.070 W) for 20 seconds per point. The point application method will be used with a conventional tip in contact with the skin (spot area: 0.04 cm²) following the protocol suggested by Venezian et al.59 and Carvalho et al.60.
15829074|NCT04211870|Radiation|Sham treatment|Sessions will be held twice a week for six weeks (total: 12 session). During sham treatment the device will emit a guide light and sound, but no energy.
15829075|NCT04211857|Device|Round XTENDOBUTTON Fixation Device used in suture fixation of ligaments and tendons in conjunction with an ULTRABUTTON™ product or ENDOBUTTON™ device.|Round XTENDOBUTTON Fixation Device used in suture fixation of ligaments and tendons in conjunction with an ULTRABUTTON™ product or ENDOBUTTON™ device.
15829076|NCT04211844|Drug|sofosbuvir plus daclatasvir|50 patients in the first group will receive 400 mg sofosbuvir plus daclatasvir 60 mg once daily for 12 weeks.
15829077|NCT04211844|Drug|Sofosbuvir plus Ledipasvir|50 patients in the second group will receive 400 mg sofosbuvir plus ledipasvir 90 mg (Harvoni) once daily for 12 weeks.
15829078|NCT04211831|Drug|URO-902|intradetrusor injection
15829079|NCT04211831|Drug|Placebo|intradetrusor injection
15829080|NCT04211818|Behavioral|Eating Behavior|A dietary book will be given to the patient and will be filled by this one during 14 days
15829081|NCT04211818|Biological|Blood glucose records|A glycemic sensor will be placed at the back of the patient's arm
15829082|NCT04211805|Drug|Tenofovir Alafenamide 25 MG for arm (A)|Tenofovir Alafenamide (TAF) will be provided, 25 mg Per Oral daily.
15829083|NCT04211805|Drug|Tenofovir Disoproxil Fumarate 300mg for arm (B)|Tenofovir Disoproxil Fumarate (TDF) will be provided, 300 mg Per Oral daily.
15829084|NCT04211792|Device|Icare Tonometer|Icare tonometers are a new class of rebound tonometers for IOP measurements. The Icare series of tonometers are hand-held tonometers, which are easy to operate and generally do not require topical anaesthesia for IOP measurements.
15829085|NCT04211779|Device|Real tDCS|Real tDCS (TCT Research Limited, Hong Kong); 3 times a week on alternate days for consecutive 6 weeks. The active session of tDCS will consist in applying anodal stimulation over left M1 (C3 according to the 10-20 international EEG placement) and the cathodal stimulation over right supraorbital area (Fp2 according to the 10-20 international EEG placement), and to inject 2 mA for 20 minutes through sponge electrodes (35 cm²) placed on the scalp.
15829086|NCT04211779|Device|Sham tDCS|Sham current (TCT Research Limited, Hong Kong); 3 times a week on alternate days for consecutive 6 weeks. The sham tDCS will use the same montage and device but direct current will only be injected for 30 seconds, with a ramp-up and ramp-down 15 seconds period, to mimic the somatosensory effects of active tDCS.
15829087|NCT04211779|Other|Exercise|The Exercise intervention will include only aerobic exercise 3 times a week on alternate days for consecutive 6 weeks. The program will last 20 minutes.
15829088|NCT04211766|Dietary Supplement|Dietary Fiber|Given fiber supplement
15829089|NCT04211766|Dietary Supplement|Fish Oil|Given fish oil supplement
15829090|NCT04211766|Other|Placebo|Given fiber supplement placebo
15829091|NCT04211766|Other|Placebo|Given fish oil supplement placebo (corn oil)
15829092|NCT04211753|Behavioral|Treatment as usual (schema therapy)|weekly group psychotherapy and bimonthly individual psychotherapy
15829094|NCT04211740|Drug|OCH-NCNP1|OCH-NCNP1 3mg is supplied as granules and take orally once a week.
15829095|NCT04211740|Drug|Placebo|Placebo is supplied as granules and take orally once a week.
15829096|NCT04211727|Diagnostic Test|Capillary finger prick blood sample|Patients will have a blood finger prick sample
15829097|NCT04211714|Biological|EXG34217|Single infusion
15829098|NCT04211701|Procedure|Connective Tissue Massage|Connective tissue massage (CTM) will be applied to the lumbo-sacral region, lower thoracic, scapular and interscapular regions. Three to five pulling will be applied during massage. The treatment will be administered for four weeks, five days a week.
15829099|NCT04211701|Procedure|Classical Massage|Classic massage (CM) will be applied to the lower back and upper back while the patient is lying in the prone position. Three stroking will be applied during massage.The treatment will be administered for four weeks, five days a week.
15829100|NCT04211688|Behavioral|Group Schema therapy|Bimonthly outpatient psychotherapy delivered in individual setting
15829101|NCT04211688|Behavioral|Individual Schema therapy|weekly outpatient psychotherapy delivered in group setting
15829102|NCT04211675|Biological|Natural Killer Cells|NK cells dose based on patient's dose level assignment, beginning Cycle 2.
15829103|NCT04211675|Drug|Temozolomide|Temozolomide 100mg/m2/dose PO or IV daily on Days 1-5; if given orally, must be at least one hour prior to Irinotecan. For patients whose body surface area is <0.5m2, temozolomide dosing is based on body weight in (kg), at a dose of 3.3 mg/kg/dose.
15829104|NCT04211675|Drug|Irinotecan|Irinotecan 50mg/m2/dose IV daily on Days 1-5
15829105|NCT04211675|Drug|Dinutuximab|Dinutuximab 17.5mg/m2/dose IV daily on Days 2-5
15829106|NCT04211675|Drug|Sargramostim|Sargramostim 250mcg/m2/dose subcutaneous daily on Days 6-12
15829107|NCT04211662|Behavioral|Tailored Multidimensional Intervention. the tailored intervention will be implemented through 6 months using a multidimensional approach (skill building, psychoeducation and peer support).|Skill-building can be defined as training the family caregivers the following skills (1) hands-on training in such skills as positioning, transferring and mobility techniques and assistance with activities of daily living; (2) coping strategies and stress management (3) communicating with healthcare professionals. Psycho-education is teaching and provision the family caregivers the knowledge and information regarding stroke (stroke definition, types of stroke, risk factors, prevention of recurrent stroke, medication management, stroke complications and measures for prevention and management of these complications). Besides, family caregivers will be taught and given the knowledge and information regarding managing stroke survivors' emotions and behaviors. Peer support can be defined as engaging the family caregivers of stroke survivors in interactions with their peers for support and exchanging advices and experiences.
15829108|NCT04211649|Drug|3 days of antibiotherapy|Reduce at 3 days of antibiotherapy for the treatment of mild leptospirosis
15829109|NCT04211623|Other|Constraint induced movement therapy|"Constrained on more affected side for three hours. To minimize the learned non use in hemiplegic CIMT is applied and criteria of applying CIMT is;
~10 degrees active wrist extension on the affected hand,
~10 degrees active thumb abduction,
~10 º active extension of any two digits on the side or hand which is limited due to damage.
~In order to gain the maximum good results from CIMT technique following points should also be considered attentively. Affected arm should move to 45 degrees shoulder flexion and abduction, and 90 degrees of elbow flexion and extension.
~Constrained with cotton sling. 3 to 5 upper limb functional activities like
~using fork or a spoon,
~combing hair
~brushing teeth
~writing
~dressing all activities are performed for 10 t0 15 minutes in period of three hours on alternate days in a week"
15829110|NCT04211623|Other|Bimanual activities|"Bimanual activities of both hands are performed like
~Set of bimanual activities is used to assess the bimanual hand function. Five bimanual activities are performed such as
~carrying a tray,
~cutting a fruit with a knife,
~holding and cutting the paper with scissor,
~buttoning and
~Carrying heavy objects with both hands.
~Every activity was performed for 10 t0 15 minutes on alternate days for a period of 6 weeks session."
15829111|NCT04211610|Diagnostic Test|Blood and urine sampling|"Blood tests - hs-cTnT, hs-cTnI, complete metabolic panel including urea, creatinine, albumin and myoglobin
~Urine tests - hs-cTnT, hs-cTnI, urea, creatinine, albumin, total protein, β2-microglobulin."
15829112|NCT04211597|Other|Control|No scar prevention or treatment.
15829113|NCT04211597|Other|Silicone gel|Dermatix® (Dermatix® Ultra, Menarini Asia-Pacific, Taiwan FDA approved)
15829114|NCT04211597|Other|microencapsulated polysaccharide and oligopeptide-1(Me-EGF) 40 mcg & 5 mcg|4ml (40 mcg) of Me-EGF spray will be given by the operating physician prior to wound closure, followed by daily application of 5 mcg until day +5 after delivery. Starting from day +14, participants will receive FDA approved Silicone gel to be applied to the Cesarean wound twice a day for two months. Participants also receive routine post-partum care as usual.
15829115|NCT04211584|Device|transradial interventions|percutaneous coronary interventions in stable patients - diagnostic and treatment
15829116|NCT04211571|Device|Theranova 400 dialyzer|Hemodialysis using Theranova 400 dialyzer
15829117|NCT04211571|Device|High-flux dialyzer|Hemodialysis using high-flux dialyzer
15829118|NCT04211558|Drug|Ozanimod|Ozanimod
15829119|NCT04211545|Drug|Rabeprazole|Rabeprazole
15829120|NCT04211545|Drug|CC-92480|CC-92480
15829121|NCT04211532|Other|Surgery|Surgical risk is calculated according to the surgery performed.
15829122|NCT04211519|Diagnostic Test|sampling|sampling from endodontically infected primary and permanent teeth by using paper point method
15829123|NCT04211506|Behavioral|Controlled sleep|Duration and timing of sleep will be assigned and monitored in a controlled laboratory environment with controlled lighting and meals.
15829124|NCT04211493|Behavioral|whole-body-workout|20 minutes whole-body-workout
15829125|NCT04211493|Device|EMS|Electromyostimulation-intensity 5 (muscle stimulation)
15829126|NCT04211493|Device|EMS-Placebo|Electromyostimulation-intensity 1 (no muscle stimulation)
15829127|NCT04211480|Biological|γ-globin reactivated autologous hematopoietic stem cells|gene edited autologous hematopoietic stem cells with γ-globin expression
15829128|NCT04211467|Other|No Intervention|There is no intervention for this study
15829129|NCT04211454|Other|No intervention|There is no intervention for this study.
15829130|NCT04211428|Other|No intervention|There is no intervention for this study
15829232|NCT04210609|Device|Vaporous Hyperoxia Therapy|55 minutes of treatment, 2 times per week
15829131|NCT04211415|Drug|DS-2741a|Single, subcutaneous injection (upper arm, upper part of the thigh, or abdominal wall in principle) administered weekly for 4 weeks
15829132|NCT04211415|Drug|Placebo|Single, subcutaneous injection administered weekly for 4 weeks
15829133|NCT04211402|Other|No Intervention|There is no intervention for this study
15829134|NCT04211389|Drug|ARQ-151 0.3% cream|ARQ-151 0.3% cream
15829135|NCT04211389|Drug|ARQ-151 vehicle cream|ARQ-151 vehicle cream
15829136|NCT04211376|Other|No Intervention|There is no intervention for this study
15829137|NCT04211363|Drug|ARQ-151 0.3% cream|ARQ-151 0.3% cream
15829138|NCT04211363|Drug|ARQ-151 vehicle cream|ARQ-151 vehicle cream
15829139|NCT04211350|Device|NightBalance Sleep Position Trainer (SPT)|NightBalance Sleep Position Trainer (SPT) avoids POSA patients from sleeping on their back by delivering a vibrational stimulus, via a small device which is worn in a chest strap during sleep, each time the patient rolls to their back. This prompts the patient to roll over onto their side.
15829140|NCT04211350|Device|Automatic Positive Airway Pressure (APAP)|Automatic Positive Airway Pressure (APAP) is a pump that provides a positive flow of air to keep the airway open.
15829144|NCT04211324|Device|TENS|Volunteers in this group (n=50) will receive only one session of 5-minute extra-oral TENS applied on bilateral parotid gland with 50 HZ frequency and pulse duration 250 µs.
15829145|NCT04211324|Device|electro-acupuncture|Volunteers in this group (n=50) will receive only one session of 5-minute electro-acupuncture on local acu-points St4 and St 7 bilateraly with 2 HZ frequency.
15829146|NCT04211311|Other|hybrid high-intensity training|FES-legcycling combined with either arm skiergometer or arm-cycling in 4 x 4 min. intervals at 90% peak power output, 3 times a week for 8 weeks
15829147|NCT04211298|Drug|Dexmedetomidine|Dexmedetomidine will be used for sedation during bronchoscopy
15829148|NCT04211298|Drug|Propofol|Propofol
15829149|NCT04211285|Diagnostic Test|e-GAB|android application for comprehensive geriatric assessment
15829150|NCT04211285|Diagnostic Test|standard physician performed CGA|CGA by an experienced geriatrician blinded to the result of e-GAB
15829151|NCT04211272|Drug|Macitentan|Macitentan will be administrated as film-coated tablet in Part A and Part B.
15829152|NCT04211272|Drug|Sildenafil|Sildenafil will be administrated as film-coated tablet in Part A.
15829153|NCT04211272|Drug|Riociguat|Riociguat will be administrated as film-coated tablet in Part A.
15829154|NCT04211272|Drug|Rosuvastatin|Rosuvastatin will be administrated as film-coated tablet in Part B.
15829155|NCT04211259|Drug|Loratadine|Given PO
15829156|NCT04211259|Other|Placebo|Given PO
15829157|NCT04211259|Other|Questionnaire Administration|Ancillary studies
15829158|NCT04211246|Procedure|Titration of fraction of inspired oxygen (FiO2) guided by SpO2|Titration of fraction of inspired oxygen (FiO2) guided by SpO2
15829159|NCT04211246|Procedure|Titration of fraction of inspired oxygen (FiO2) guided by ORI and SpO2|Titration of fraction of inspired oxygen (FiO2) guided by ORI and SpO2
15829160|NCT04211233|Device|invasive subdural grid electrode|A subdural EEG-electrode (PLATIN 1x4 or 1x6; Ad-Tech Medical Instrument Corporation, Oak Creek, WI, USA, Figure 1) will be implanted in the subdural space frontotemporal intraoperatively and diverted separately from the wound area. Afterwards, invasive Monitoring will be performed for 7 days and the grid will be removed simply by pulling out.
15829161|NCT04211233|Other|Control arm|Standard Treatment based on Brain Trauma Foundation
15829162|NCT04211220|Other|A decision support software|Insulin pump Continuous glucose monitoring
15829163|NCT04211207|Other|non invasive monitoring value|heart's respiratory quotient as non invasive monitoring value
15829164|NCT04211194|Procedure|Upper GI Endoscopy|Patients with upper gastrointestinal bleeding undergoing endoscopic therapy. Information regarding the need for interventional radiology procedures or surgical interventions will also be collected in patients in whom endoscopic therapy is not successful.
15829165|NCT04211181|Other|The multifaceted interventions|"An evidence-based clinical guideline and pathway in hospital.
~A series Written care protocols for the implementation of performance measures.
~A computer-based clinical decision support system(CDSSs) and a computerized reminder, which was referred to as a key element to enhance VTE assessment and prophylaxis. A well-designed computer program will be integrated into the Electronic Medical Record(EMR) of intervention group and By processing, analyzing, summarizing and representing crucial information, physicians can be altered.
~A full-time quality coordinator
~A trained physician or nurse in each intervention cluster will be acted as a quality coordinator. The responsibility of the quality coordinator includes:"
15829166|NCT04211181|Other|Routine VTE prophylaxis|Patients randomized to the Routine VTE prophylaxis (Control) group will receive routine VTE prophylaxis according to current guidelines and clinical practices
15829167|NCT04211168|Drug|Toripalimab plus Lenvatinib|"Toripalimab 240mg, every 3 weeks, intravenous infused, day 1, 6 weeks a cycle.
~Lenvatinib 8mg (weight<60kg) or 12mg (weight≥60kg), once a day, orally, day 2, 6 weeks a cycle. Dose reduction to 4mg/d or dose termination is allowed according to adverse events.
~Number of cycle: until progression or unacceptable toxicity events develop."
15829168|NCT04211155|Other|Questionnaires|The participant will complete questionnaires, including ones on pubertal development and quality of relations with parents and friends.
15829169|NCT04211155|Other|MRI|Within 2 weeks of the first study visit, the participant will return to the University where they will undergo MRI.
15829170|NCT04211142|Procedure|Laparoscopic Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP repair)|Laparoscopic inguinal hernia repair
15829171|NCT04211142|Procedure|Open Inguinal Hernia Repair (Lichtenstein repair)|Open Inguinal Hernia Repair
15829172|NCT04211129|Other|acupuncture|Patients receiving acupuncture and mild moxibustion, whom were treated 3 times per week for 12 weeks and followed up for 36 weeks. CV12 and Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and bilateral ST25 and ST36 were selected for moxibustion. Hwato acupuncture device was used to blind the subjects, and had the deqi sensation. The surface temperature of acupoints was maintained at 43℃± 1℃ for moxibustion.
15829173|NCT04211129|Other|Sham acupuncture|Patients receiving sham acupuncture and sham mild moxibustion, whom were treated 3 times per week for 12 weeks and followed up for 36 weeks. CV12 and Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and bilateral ST25 and ST36 were selected for moxibustion. Same Hwato acupuncture device was used to blind the subjects, but do not puncturing into the skin and do not have the deqi sensation. The surface temperature of acupoints was maintained at 37℃± 1℃ for moxibustion.
15829174|NCT04211116|Device|Central venous line insertion|Pediatric patients indicated to central venous line insertion
15829175|NCT04211103|Drug|Pembrolizumab|Humanized antibody used in cancer immunotherapy. It targets the programmed cell death protein 1 (PD-1) receptor of lymphocytes.
15829176|NCT04211090|Drug|Camrelizumab|Camrelizumab with pemetrexed / carboplatin in patients with brain metastases of driven gene-negative, non-squamous non-small cell lung cancer, Participants receive a 3-week cycle (Q3W) treatment，Treatment continued until disease progression or unacceptable toxicity or death or, for the immunotherapy regimens
15829177|NCT04211090|Drug|Pemetrexed|Camrelizumab with pemetrexed / carboplatin in patients with brain metastases of driven gene-negative, non-squamous non-small cell lung cancer, Participants receive a 3-week cycle (Q3W) treatment，Treatment continued until disease progression or unacceptable toxicity or death or, for the immunotherapy regimens
15829178|NCT04211090|Drug|Carboplatin|Camrelizumab with pemetrexed / carboplatin in patients with brain metastases of driven gene-negative, non-squamous non-small cell lung cancer, Participants receive a 3-week cycle (Q3W) treatment，Treatment continued until disease progression or unacceptable toxicity or death or, for the immunotherapy regimens
15829179|NCT04211077|Other|Date collection|Data collection from national SNIIRAM and PMSI database
15829180|NCT04211064|Diagnostic Test|Ultrasonographic measurement of optic nerve sheath diameter|Optic nerve sheath diameter will be measured at both neuromuscular blocks level.
15829181|NCT04211064|Procedure|Deep neuromuscular block|Deep neuromuscular block will be obtained via appropriate dose of rocuronium.
15829182|NCT04211064|Procedure|Moderate neuromuscular block|Moderate neuromuscular block will be obtained via appropriate dose of rocuronium.
15829183|NCT04211051|Device|LungBrella marker implantation and VATS partial lobe resection|The enrolled patients will receive a plain chest CT scan,then the data be loaded into JediVision software. The JediVision software can navigate the location of nodule and facilitate the implantation of LungBrella marker in the operating room after general anesthesia,then the patients will receive VATS partial lobe resection .
15829184|NCT04211038|Device|inspiratory threshold load device|"Before experiment ,every subject use a flanged mouthpiece attached to a manually operated occlusion valve in order to measure maximal inspiratory pressure (MIP)at functional residual capacity .
~And then, the healthy subjects will be increased the neural respiratory drive by increasing the pressure in a water-sealed inspiratory threshold loading device. At last, all subjects will do Incremental cycle ergometry test with the assisstance of NPPV."
15829185|NCT04211025|Other|Modest|The modest intervention consists of a 30-minute appointment (by phone or in-person) with the designated staff using the Benefits Screening Tool , and a plan is developed. At 4 weeks, the designated staff follows-up with a phone call or email.
15829186|NCT04211025|Other|Intensive|The intensive intervention consists of a 30-minute appointment with the designated staff using the Benefits Screening Tool , and a plan is developed. At 4 weeks, a follow-up appointment is booked for 30 minutes, and progress on the plan is assessed. At 12 weeks after the initial meeting, the designated staff follows-up with a phone call or email.
15829187|NCT04211012|Drug|Toripalimab plus Nab-Paclitaxel +/- cisplatin|"Toripalimab injection (JS001): 240mg, i.v.gtt, q3w; Nab-Paclitaxel: 260mg/m2, i.v.gtt, q3w Cisplatin: total dosage of 70 mg/m2 i.v.gtt, q3w，, complete all doses within the first 2 days of each cycle.
~Study treatment will be continued until disease progression or intolerable toxicity, or withdrawal at the discretion of the investigator or the subject, loss to follow-up, or initiation of other anti-cancer therapy, or death, whichever occurs first. Toripalimab will be administered no more than 2 years,and nab-paclitaxel with or without cisplatin will be administered up to 6 cycles.. If the subject is intolerable to cisplatin treatment according to the investigator's judgment, JS001 + Nab-Paclitaxel may be dosed.
~Dosing sequence: Toripalimab, Nab-Paclitaxel, cisplatin"
15829188|NCT04210999|Other|Homebased resistance training|Resistance training at home instructed via a smart phone training app
15829189|NCT04210999|Other|Supervised heavy slow resistance training|Heavy slow resistance training in the gym instructed by a physiotherapist
15829190|NCT04210986|Dietary Supplement|Fisetin|Fisetin will be administered orally at 20 mg/kg for two consecutive days, followed by 28 days off, then 2 more consecutive days.
15829191|NCT04210986|Drug|Placebo oral capsule|Placebo will be administered orally for two consecutive days, followed by 28 days off, then 2 more consecutive days.
15829192|NCT04210973|Drug|Anyu Peibo|Anyu Peibo Capsule, 0.8g twice per day, oral after breakfast and supper
15829193|NCT04210973|Drug|Placebo|Placebo Capsule, twice per day, oral after breakfast and supper
15829194|NCT04210960|Radiation|Magentic resonanace imaging|The brain MR imaging examinations were done by using a 3 tesla scanner (Acheiva; Philips Medical Systems, Best, Netherlands). All patients were examined in the supine position using head coil. Routine images (T2, T1, FLAIR) and double inversion recovery sequence (DIR) were done to all patients: repetition time (TR) _ 9583 sec, echo time (TE) _ 25 sec, inversion time (TI) _ 3400 sec, IR delay _ 325 sec, echo train length (ETL) _ 17, 50 contiguous axial slices, thickness _ 3 mm, matrix size 240× 142 mm2, field of view (FOV) 230× 184 mm2.
15829195|NCT04210960|Radiation|Magentic resonanace spectroscopy|Magnetic Resonance (MR) spectroscopy is a noninvasive diagnostic test for measuring biochemical changes in the brain.While magnetic resonance imaging (MRI) identifies the anatomical location of a lesion, MR spectroscopy compares the chemical composition of normal brain tissue with abnormal brain tissue. This test can also be used to detect tissue changes in stroke and epilepsy.
15829196|NCT04210947|Other|30 rolls per minute(30RPM)|Participants will start using foam roller from muscle origin to insertion with a speed of 2 secs. Then comeback from insertion to origin with 2 secs. With total of 15 repeats x 2 sets per leg. With 30 seconds rest between.
15829197|NCT04210947|Other|15 rolls per minute(15RPM)|Participants will start using foam roller from muscle origin to insertion with a speed of 4 secs. Then comeback from insertion to origin with 4 secs. With total of 15 repeats x 2 sets per leg. With 30 seconds rest between.
15829198|NCT04210947|Other|self-determined|Participants will start using foam roller from muscle origin to insertion with self determined-speed. Then comeback from insertion to origin with same pace. With total of 15 repeats x 2 sets per leg. With 30 seconds rest between.
15829199|NCT04210921|Device|Acupuncture|"The acupuncture will be penetrated in an appropriate angle into a depth of 10-15 mm. Acupuncture manually manipulated by lifting, thrusting, and twirling methods to produce a characteristic sensation known as De Qi ."
15829200|NCT04210921|Device|The park sham needle|When the blunt needle goes through the adhesive and contact with skin, it will move back into the hollow centre of the handle rather than penetrate into skin.
15829201|NCT04210908|Other|Visual biofeedback|Patient will observe the descent of the fetal head as they push during contractions
15829202|NCT04210895|Other|Ginger powder footbath|40 ± 2 ° C warm water footbath with an additive of dried ginger powder reaching up to mid-calf level
15829203|NCT04210895|Other|Warm water only footbath|40 ± 2 ° C warm water footbath without any additive reaching up to mid-calf level
15829204|NCT04210882|Behavioral|Moderate-Intensity Exercise|See description of study arm.
15829205|NCT04210869|Dietary Supplement|Mixed Nuts|Study volunteers will receive daily 60 g of mixed nuts (15 g walnut, 15 g cashew, 15 g hazelnut, 15 g pistachio) for 16 weeks.
15829206|NCT04210856|Other|Contemplative landscape exposure|landscapes classified as contemplative (through a CLM psychometric measure) are expected to elicit different brainwave oscillations as compared to non-contemplative ones.
15829208|NCT04210830|Diagnostic Test|Quantra-Device|Point of Care Coagulation Monitoring System
15829209|NCT04210817|Other|No Intervention|There is no intervention for this study
15829210|NCT04210804|Dietary Supplement|Smoothie 1g Eicosapentaneoic Acid (EPA) and 1g Docoshaexanoic Acid (DHA)|200mls Smoothie
15829211|NCT04210778|Behavioral|Cognitive orientation to daily occupational performance (CO-OP)|The CO-OP is a client-centered, goal directed approach aimed at enabling individuals to identify strategies that will improve daily function. A Weekly (1hr) session is delivered remotely via video conferencing.
15829212|NCT04210778|Behavioral|Computerized Cognitive Training (BrainHQ, posit science)|The BrainHQ training targets multiple cognitive domains. The training will be delivered remotely, using a web-based program. Training progresses in an adaptive, individualized manner, based on individual progression of each participant . Participants are required to practice a minimum of half hour, three times a week (total of 1.5hr)
15829213|NCT04210765|Drug|Clomiphene Citrate|Clomiphene citrate used in incremental doses in nonresponsive cases.
15829214|NCT04210752|Drug|Treatment 1 (EG-HZ-001)|"Subjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment)
~Route of Administration: IM injection"
15829215|NCT04210752|Drug|Treatment 2 (EG-HZ-002)|"Subjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment)
~Route of Administration: IM injection"
15829216|NCT04210752|Drug|Treatment 3 (EG-HZ-003)|"Subjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment)
~Route of Administration: IM injection"
15829217|NCT04210752|Drug|Treatment 4 (EG-HZ-004)|"Subjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment)
~Route of Administration: IM injection"
15829218|NCT04210752|Drug|Treatment 5|"Shingrix
~Suspension for injection supplied as a single dose vial of lyophilised VZVgE antigen component to be reconstituted with the accompanying vial of AS01B adjuvant suspension component. After reconstitution, a single dose of ShingrixTM is 0.5 mL.
~Route of Administration: IM injection"
15829219|NCT04210739|Drug|Betamethason Sodium Phosphate|Injection of betamethasone in chronic non bacterial prostatitis patients using Trans rectal Ultrasound
15829220|NCT04210726|Other|25% Hypertonic Saline Bath|25% Sea Salt (mainly Sodium Chloride - NaCl) in Tap Water Immersion Bath (made by adding Sodium Chloride in the form of Sea Salt to Tap Water to a concentration of 25%).
15829221|NCT04210726|Other|0.9% Isotonic Saline Bath|0.9% Sea Salt (mainly Sodium Chloride - NaCl) in Tap Water Immersion Bath (made by adding Sodium Chloride in the form of Sea Salt to Tap Water to a concentration of 0.9%).
15829222|NCT04210713|Drug|Minocycline|200 mg/day
15829223|NCT04210713|Drug|Sugar pill|Matched placebo
15829224|NCT04210700|Procedure|Fascia iliaca compartment block|"A linear ultrasound transducer is placed in a sagittal plane to identify the anterior superior iliac spine. By sliding the transducer medially, the fascia iliaca and abdominal internal oblique, sartorius, and iliopsoas muscles are identified. After identifying the bow-tie sign, a 23-gauge needle (7mm, Nipro, Japan) is inserted in plane from caudal to cephalad until the needle tip penetrate the fascia iliaca. After negative aspiration, 0.35% ropivacaine 30mL with 1:400,000 epinephrine will be injected to separate the fascia iliaca and the iliacus muscle."
15829225|NCT04210700|Procedure|Pericapsular nerve group block|A curvilinear ultrasound transducer is initially place on the anterior inferior iliac spine and then aligned to the iliopubic eminence by rotating around 45 degree. In this view, the iliopubic eminence, iliapsoas muscle and tendon, pectineus muscle, femoral artery and vein will be identified. A 23-gauge needle (7mm, Nipro, Japan) is inserted in plane from lateral to medial until the needle tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. After negative aspiration, 0.35% ropivacaine 20mL with 1:400,000 epinephrine will be injected.
15829226|NCT04210687|Procedure|trapeziometacarpal limited excision|Narrow pseudarthrosis CMC1
15829227|NCT04210687|Procedure|Trapeziectomy|Simple trapeziectomy
15829228|NCT04210674|Other|The traditional medicinal product of Argan spinosa oil|All children were randomly divided into two groups to receive either the traditional medicinal product of Argan spinosa oil or The conventional topical steroid ointment.
15829229|NCT04210661|Other|prediction software with spell checker|test with prediction software with spell checker
15829230|NCT04210648|Device|Mobile app|Mobile app for self-managing emotional dysregulation
15829231|NCT04210635|Other|ZEN cart|essential oils + relaxing music + dim light
15829233|NCT04210596|Procedure|Soft tissue augmentation at the buccal aspect of single implants|Soft tissue augmentation is performed following mucoperiosteal flap elevation at the buccal aspect of single implants. The connective tissue graft (control) or collagen matrix (test) is inserted in the buccal pouch and attached with monofilament sutures.
15829234|NCT04210583|Device|Vulvovaginal Treatment|"Device model(s) - Venus Fiore™ Device settings and programming internal applicator - 42°C - 45°C Temperature output via automatic temperature control (ATC) (optional treatment).
~Duration of exposure and frequency of exposure with internal applicator - one treatment for 12-15 minutes at 12 months (optional treatment).
~Device settings and programming external mons pubis and labia applicators - 10-35% output (optional treatment).
~Duration of exposure and frequency of exposure external applicators - one treament for 15 minutes for the mons pubis, 10 minutes for labia at 12 months (optional treatment)."
15829235|NCT04210570|Device|Memsorb|Memsorb uses a polymeric membrane (similar to the ones used in oxygenators for cardiac surgery) that selectively allows CO2 to leave the rebreathing system while maintaining the inhalational anesthetic in the anesthesia circuit
15829236|NCT04210570|Drug|Chemical granulate absorber|Chemical granulate absorber trap CO2 chemically in granules that are later disposed of when absorption capacity is reached
15829237|NCT04210557|Device|Transcranial Magnetic Stimulation (TMS)|Transcranial magnetic stimulation (TMS) is a noninvasive form of brain stimulation in which a changing magnetic field is used to cause electric current at a specific area of the brain through electromagnetic induction. An electric pulse generator, or stimulator, is connected to a magnetic coil, which in turn is connected to the scalp. The stimulator generates a changing electric current within the coil which induces a magnetic field; this field then causes a second inductance of inverted electric charge within the brain itself.
15829238|NCT04210544|Dietary Supplement|Experimental dietary protein|Breakfast intake consisted on a 250 g custard intake mixed with 20 g of the experimental protein accompanied by a glass with 50 mL water.
15829239|NCT04210544|Dietary Supplement|Casein|Breakfast intake consisted on a 250 g custard intake mixed with 20 g of casein accompanied by a glass with 50 mL water.
15829240|NCT04210544|Dietary Supplement|Water|Breakfast intake consisted on a 250 g custard intake mixed with 20 g of water accompanied by a glass with 50 mL water.
15829241|NCT04210531|Dietary Supplement|Beetroot juice (BJ) acute supplementation|One serving 140 mL of BJ (12.8 mmol of NO3-; Beet-It-Pro Elite Shot, James White Drinks Ltd., Ipswich, UK) after an overnight fast and 3 h before initiating the testing session.
15829242|NCT04210531|Dietary Supplement|Placebo acute supplementation|One serving placebo drink (0.08 mmol of NO3-; Salud Viva, Nano Salud 32 S.L) after an overnight fast and 3 h before initiating the testing session.
15829243|NCT04210518|Other|Neuromuscular training|This intervention consisted of a supervised multimodal exercise protocol addressing different aspects of balance including static and dynamic tasks on the injured ankle. The training program comprised 6 exercises that were progressively adapted depending on the patient's execution controlled by an expert physiotherapist
15829244|NCT04210518|Other|Stroboscopic glasses|Patients included in this group performed the same protocol described in the balance training group with the addition of the stroboscopic glasses during the intervention.
15829245|NCT04210505|Drug|Povidone-Iodine Topical Ointment|Intranasal povidone-iodine will be applied to the lower anterior nares (i.e. nostril) of patients undergoing hemodialysis before each session.
15829246|NCT04210505|Other|Standard Care|Control group will receive standard care as provided by the dialysis center
15829247|NCT04210492|Radiation|45 Gray (Gy) regimen|Deescalated 3-fraction stereotactic body radiotherapy regimen to 45 Gy in 3 fractions.
15829248|NCT04210479|Procedure|Filled-bladder|Urinary bladder filling with 300 ml diluted methylene blue
15829249|NCT04210479|Procedure|non filled-bladder|Pull up the empty (non-filled) urinary bladder using Allis forceps
15829250|NCT04210466|Behavioral|Acceptance & Commitment Therapy + Compassion (COMP.ACT)|8 sessions, 2h each. Intervention includes meditation exercises, behavioral exercises, group discussions, and the structure is the following Session 1: INTRODUCTION: control is the problem Session 2: THE BODY AS PRESENT: promoting body awareness through mindfulness Session 3: COMPASSION I: from self-criticism to self-care Session 4: COMPASSION II: the body as an anchor to self-compassion Session 5: ACCEPTANCE: there is more to accept than just pain Session 6: (RE)DISCOVERING VALUES: in search of a valued life Session 7: ACT NOW: from values to committed action Session 8: CARRY ON AFTER COMP.ACT: program summary
15829251|NCT04210466|Behavioral|Acceptance and Commitment Therapy (ACT)|8 sessions, 2h each. Intervention includes meditation exercises, behavioral exercises, group discussions, and the structure is the following Session 1: INTRODUCTION: control is the problem Session 2: THE BODY AS PRESENT: promoting body awareness through mindfulness Session 3: Q&A 1 Session 4: Q&A 2 Session 5: ACCEPTANCE: there is more to accept than just pain Session 6: (RE)DISCOVERING VALUES: in search of a valued life Session 7: ACT NOW: from values to committed action Session 8: CARRY ON AFTER COMP.ACT: program summary
15829252|NCT04210453|Drug|Vitamin C|"Participants in Vitamin C group are administered IV vitamin C diluted in 100 cc normal saline 1 day before surgery, at rewarming during surgery, 3 hours after surgery, and every 6 hours thereafter until postoperative 24 hours."
15829253|NCT04210453|Drug|Control (Normal saline)|"Participants in Control group are administered IV 100cc normal saline at the same timepoint as above."
15829254|NCT04210440|Procedure|Core decompression procedure|Core Decompression with Bone Chips Allograft adjuvanted by Fibrin Platelet Rich-plasma (PRP) and Concentrated Autologous Mesenchymal Stromal Cells (MSCS), isolated from Bone Marrow
15829255|NCT04210427|Drug|Polyethylene Glycol 3350|All patients will undergo intervention with taking polyethylene glycol (PEG) or Miralax (brand name) 17 grams once daily for total of 2 weeks.
15829256|NCT04210427|Device|SmartPill Motility System & PillCam Patency Capsule|Patients will ingest a Smart pill to obtain baseline motility within the GI lumen. After two weeks of therapy, the patient will repeat the motility survey and again ingest a smart pill to assess the change in motility symptoms while on therapy.
15829257|NCT04210414|Other|Embryo transfer|Transfer of only one embryo
15829258|NCT04210401|Other|Duodenoscope Culture|Culture of reusable duodenoscopes following each use.
15829259|NCT04210388|Drug|AZD5718 tablet, Formulation A|Volunteers will receive single doses of AZD5718 tablet, Formulation A under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours.
15829260|NCT04210388|Drug|AZD5718 tablet, Formulation B|Volunteers will receive single doses of AZD5718 tablet, Formulation B under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours.
15829261|NCT04210388|Drug|AZD5718 tablet, Formulation C|Volunteers will receive single doses of AZD5718 tablet, Formulation C under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours.
15829262|NCT04210388|Drug|AZD5718 tablet, Formulation D|Volunteers will receive single doses of AZD5718 tablet, Formulation D under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours.
15829263|NCT04210388|Drug|AZD5718 film-coated tablet, Reference treatment|Volunteers will receive single doses of AZD5718 film-coated tablet, Reference treatment under fasted conditions. The dose will be administered with 240 mL (8 fluid ounces) of non-carbonated water after an overnight fast of at least 10 hours.
15829264|NCT04210375|Drug|JK07|Recombinant fusion protein consisting of a fully human immunoglobulin G1 monoclonal antibody and an active polypeptide fragment of the human growth factor NRG-1
15829265|NCT04210375|Drug|Matching Placebo|Vehicle control
15829266|NCT04210362|Behavioral|Workshops on responsive caregiving|Caregivers will receive monthly workshops about several dimensions of nurturing care, responsive caregiving and early child development. Workshops will be reinforced through home visits.
15829267|NCT04210349|Biological|Quadrivalent Influenza Vaccine|Pharmaceutical form: Suspension for injection Route of administration: intramuscular
15829268|NCT04210349|Biological|Trivalent Influenza Vaccine 1 SP Shz TIV1|Pharmaceutical form: Suspension for injection Route of administration: intramuscular
15829269|NCT04210349|Biological|Trivalent Influenza Vaccine 2 SP Shz TIV2|Pharmaceutical form: Suspension for injection Route of administration: intramuscular
15829270|NCT04210336|Device|PAPILOCARE|"Papilocare®: Vaginal Gel based on Coriolus versicolor, medical device class IIa.
~Route of administration: topical (vaginal). Papilocare® consists of the following ingredients: hyaluronic acid niosomes, β-glucans (magnolol, honokiol and carboxymethyl betaglucan) niosomes, BioEcolia® (Alpha-oligoglycan), Coriolus versicolor, Azadirachta indica (Neem) extract, Centella asiatica and Aloe vera."
15829271|NCT04210336|Device|PLACEBO|The placebo consists of a carrier gel with the absence of the active ingredients of Papilocare®.
15829272|NCT04210323|Device|ShotBlocker®|The injection area gripped with ShotBlocker®, released after the drug administration and then the ShotBlocker® was removed. After injection, light pressure was applied to the injection area with dry cotton.
15829273|NCT04210323|Device|Placebo group|The smooth surface (opposite side) of the ShotBlocker® was placed in the injection area just before administration by an experience registered nurse and the drug was injected by holding it on the skin surface during the injection. The process was managed by the researcher.
15829274|NCT04210310|Drug|Oxytocin|The investigational product, oxytocin nasal spray (45 units/0.1mL for 38mL) is composed of: oxytocin powder (0.3080g), magnesium chloride crystals (2.3100g), citric acid anhydrous gran. (0.1080g), sodium citrate powder (2.1500g), sterile water for irrigation (38.000mL), and Pcca Mucolox liquid base (3.8000mL). Subjects will be asked to self-administer the study medication with 1 puff in one nostril 4 times per day
15829275|NCT04210310|Other|Placebo nasal spray|A placebo nasal spray, consisting of magnesium, chloride crystals, citric acid anhydrous gran., sodium citrate powder, sterile water for irrigation, and Pcca Mucolox liquid base. Both active drug and the placebo will appear identical in the glass bottles. The placebo will be administered in the same manner as the active study drug, with 1 puff in one nostril four times per day.
15829276|NCT04210284|Dietary Supplement|Ensure|"Ensure Max Protein Shake is an over the counter available drinkable nutritional supplement. Per serving, it contains:
~160 Calories, 20 from fat
~2g Total fat
~0.5g Saturated fat
~20mg Cholesterol
~135mg Sodium
~170mg Potassium
~19g Total carbohydrate
~<1g Fiber
~4g Sugar
~16g Protein
~Participants will receive Ensure High Protein for 2 weeks pre- and 4 weeks post-operatively. These patients will be instructed to consume 1 serving (16fl oz) of Ensure High Protein daily. They will be provided with this product at a pre-operative clinical visit or have it mailed to their home. Hematologic nutritional values will be measured as specified previously.
~Descriptive statistics will be used to report baseline characteristics and primary study objectives. Hematologic outcomes will be compared between the control (NO ENSURE) and oral supplementation (ENSURE) arms for the aforementioned baseline and perioperative variables"
15829277|NCT04210271|Behavioral|Buddy self-testing condition|
15829278|NCT04210271|Behavioral|Control self-screening condition|
15829279|NCT04210258|Device|Etermis 3|Cross-linked hyaluronic dermal filler. Treatment and follow-up according to standard of care and instruction of use for filling facial moderate wrinkles (marionette lines) and/or to increase lip volume
15829280|NCT04210258|Device|Etermis 4|Cross-linked hyaluronic dermal filler. Treatment and follow-up according to standard of care and instruction of use for filling deep and severe volume loss (nasolabial folds and/or marionette lines) and/or to increase lip volume
15829281|NCT04210245|Biological|aldafermin|aldafermin
15829282|NCT04210245|Other|Placebo|Placebo for aldafermin
15829283|NCT04210232|Device|TECNIS® TORIC II Intraocular Lens (IOL)|Surgeons will perform standardized, small-incision, cataract surgery and implant in one or both eyes the study lenses.
15829284|NCT04210219|Drug|JNJ-64264681|JNJ-64264681 capsule will be administered orally.
15829285|NCT04210206|Other|PHE-diet|phenylalanine-restricted diet with phenylalanine free supplements for 8 weeks
15829286|NCT04210193|Drug|ALK Alutard 5-grasses|0.1 mL of 10 000 SQ-U/mL (1000 SQ-U) as an intralymphatic injection
15829287|NCT04210193|Drug|ALK Diluent|0.1 mL of ALK Diluent as an intralymphatic injection
15829288|NCT04210180|Drug|Varenicline|0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7; then 1 mg twice daily for the remaining 11 weeks.
15829289|NCT04210180|Other|e-cigarette|Each G6 prefilled cartomizer contains a 50/50 blend nicotine salt with 35mg nicotine strength.
15829290|NCT04210167|Behavioral|web-based training and telephone monitoring|web-based training and telephone monitoring and short message
15829291|NCT04210154|Device|Haemodiafiltration|pre-dilution and post-dilution Haemodiafiltration
15829292|NCT04210141|Biological|lyophilized BPI viper antivenom|Antivenom
15829301|NCT04210102|Diagnostic Test|Lung Ultrasound (LUS)|"Lung Ultrasound : Ultrasound is a medical imaging technique that relies on the use of ultrasound, inaudible sound waves, which allow to visualize lungs."
15829302|NCT04210102|Diagnostic Test|Chest radiography (CR)|The chest X-ray is a medical imaging examination that provides images of the lungs through the X-ray pulse.
15829303|NCT04210089|Device|Total Contact Soft Cast|"The total contact soft cast will consist of wound dressing of choice to the ulcer and a plantar foot accommodative offloading felt pad for all foot ulcers, with 4x4 gauze pads added to the arch to create a rocker bottom for metarsophalangeal joint (MPJj) and plantar heel ulcers. The next layers will be:
~Unna boot from MPJs to just below the knee,
~Sterile Kerlix from MPJs to just below the knee
~Sterile 4 inch Kling wrap from the MPJs to just below the knee,
~Four inch coban from MPJs to just below the knee, and
~Ace wraps from MPJs to just below the knee"
15829304|NCT04210089|Device|Cam Boot|Removable Diabetic cam boot will be used in patients willing and capable of using it. If patient does not want to use Diabetic cam boot then surgical shoe or regular shoe would be options.
15829305|NCT04210076|Behavioral|MBAT-T|The MBAT-Team program is a 10-hour program. This course builds on the basic 4-week, 8-hour MBAT-Soldier program. In addition to the basic program, MBAT-Team includes exercises promoting the cultivation of attention and emotion regulation in the service of effective team interactions (e.g., mindful communication and listening; monitoring and attention to the activities and emotional states of others, and additional practices to promote collective mindfulness).
15829306|NCT04210076|Behavioral|MBAT-I|The MBAT-Individual program is a 10-hour program based on the basic 4-week, 8-hour MBAT curriculum. It includes an additional 2 hours to match the duration of the 10-hour MBAT-Team program. These additional two hours allow for an extension of practice duration and discussion.
15829307|NCT04210063|Other|Inspiratory Muscle Training (IMT)|IMT is a breathing training technique customized to participant's breathing capacity. Using a handheld electronic manometer (Pro2Fit from Smithfield), a study personnel will initiate training at 40-60% maximal inspiratory pressure. Adjustments will be customized to where the participant reports a difficulty of training between 4-6 out of 10. Training sessions will be performed about 30 minutes a day for 28 consecutive days.
15829308|NCT04210050|Device|Home noninvasive nocturnal ventilation with Breas VIVO 50 home ventilator or newer model as available, Breas Medical.|"In the usual care plus NIPPV group, those able to undergo attended PSG will be titrated with volume targeted pressure support mode, aiming to lower the baseline TcCO2 by 10 mmHg. In some cases, the CO2 cannot be lowered by that amount on a single titration, but rather will decrease over time.
~For those unable to undergo lab titration (too frail, no transportation, decline/refuse), NIPPV will be initiated with empiric settings based on nighttime home CO2 tracking and daytime ABG monitoring."
15829309|NCT04210050|Diagnostic Test|Arterial blood gas (ABG) and serum bicarbonate level|Will be obtained at baseline (before randomization), then at 3, 6 and 12 months into the study
15829310|NCT04210050|Diagnostic Test|Overnight home oximetry and transcutaneous CO2 monitoring|will be conducted at 1 and 6 months into the study (for subjects in the NIPPV plus usual care group, testing will be done while using the ventilator.
15829311|NCT04210037|Drug|APG-1252|APG-1252 (Ascentage Pharma) is a highly potent Bcl-2 family protein inhibitor with high binding affinity for Bcl-2, Bcl-xL and Bcl-w. APG-1252 possesses strong antitumor activity as a single-agent against tumor cells addicted to Bcl-2/Bcl-xL, and exhibits a much broader antitumor activity when combined with chemotherapeutic agents.
15829312|NCT04210037|Drug|Paclitaxel|80 mg/m˄2 on days 1 and 8 of a 21-day cycle
15829313|NCT04210024|Other|Diabetes Empowerment Education Program|Individuals identified as Community Health Workers will participate in the Diabetes Empowerment Education Program (DEEP™). DEEP, is an education curriculum designed to help people with pre-diabetes, diabetes, relatives and caregivers gain a better understanding of diabetes self-care. Classes last a total of six weeks, providing participants with eight unique learning modules. Health literacy will be assessed before and after participating in DEEP.
15829314|NCT04209998|Diagnostic Test|transcutaneous oximetry|Analysis of transcutaneous oximetry (Tcpo2) in terme of variability at rest and of response to oxygen inhalation
15829315|NCT04209985|Behavioral|Health coaching|Brief telephonic intervention consisting of up to five phone calls from a health coach
15829316|NCT04209972|Device|Precision Ultra-High-Resolution CT scanner|Patients will be divided on one of the two CT scanners. This group will be scanned on the Precision CT scanner.
15829317|NCT04209972|Device|Genesis high-end CT scanner|Patients will be divided on one of the two CT scanners. This group will be scanned on the Aquilion one Genesis.
15829318|NCT04209959|Drug|nifekalant|Nifekalant was randomly given intravenously as a loading dose of 0.3 mg/kg, 0.4 mg/kg, or 0.5 mg/kg for five minutes without the continuous infusion for all study population, while blood pressure, surface electrocardiograms (ECG), intracardiac electrograms were monitored for half an hour. While nifekalant was given intravenously, QT interval, QTc interval and RR interval were recorded at 0, 1, 3, 5, 10, 15, 20 and 30minutes, respectively, because drug action almost disappeared within 30minutes since a single dose of intravenous nifekalant injection. These doses of nifekalant were determined based on the results of the previous study and the medicine operation instruction. Once AF continued after administration or Torsade de points was observed, external electrical cardioversion was given immediately.
15829319|NCT04209946|Procedure|Less Invasive Surfactant Administration LISA|Laryngoscopy with insertion of a small 16 gauge angiocatheter to administer FDA approved Surfactant, during spontaneous respirations.
15829320|NCT04209946|Procedure|Continuous Positive Airway Pressure CPAP|Infant will remain on CPAP Therapy during spontaneous respirations
15829321|NCT04209933|Drug|Bismuth potassium citrate containing quadruple therapy|Bismuth potassium citrate:given for 14 days at a dose of bismuth potassium citrate 220 mg 0 BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID
15829322|NCT04209933|Drug|Colloidal pectin bismuth capsules containing quadruple therapy|Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth capsules 200 mg 0 BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID
15829323|NCT04209933|Drug|Colloidal pectin bismuth particles A quadruple therapy|Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth particles 150 mg BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID
15829352|NCT04209686|Drug|Olaparib|"Olaparib will be taken by mouth daily for 3 weeks (every 21 days).
~Drug - 100 mg or 300mg"
15829324|NCT04209933|Drug|Colloidal pectin bismuth particles B quadruple therapy|Bismuth potassium citrate:given for 14 days at a dose of Colloidal pectin bismuth particles 300 mg BID,rabeprazole 10 mg BID, amoxicillin 1000 mg BID, and clarithromycin 500 mg BID
15829325|NCT04209920|Device|CAD-CAM milled PMMA crown|the patient will receive a full coverage restoration for hypomineralized first permanent molar in patient suffering from molar incisor hypomineralization using PMMA disks using a CAD-CAM technology.
15829326|NCT04209920|Other|Cast metal coping using nickel chromium alloy|the patient will receive a full coverage restoration for hypomineralized first permanent molar in patient suffering from molar incisor hypomineralization using Nickel Chromium alloy to make a Cast Coping.
15829327|NCT04209907|Other|retrolaminar block tecnique|By using ultrasound probe, the needle with in-plane , after seeing vertebral lamina, the local anesthetic will injectate
15829328|NCT04209894|Diagnostic Test|Ultrasound|Evaluation consisted of the detection of grey scale (GS) enthesitis and Power Doppler signal in enthesis areas of participants. The Madrid Sonography Enthesitis Index (MASEI) scoring system was used to quantify the extent of sonographic entheseal abnormalities
15829329|NCT04209881|Other|ovarian reserve for Ankylosing spondylitis and control groups|"Additional organ diseases due to the pathophysiology of the disease may be seen in women with ankylosing spondylitis. therefore, we established the first group of women with the diagnosis of ankylosing spondylitis.
~Women Who Are Diagnosed With Ankylosing Spondylitis Will Form The Study Group. and health women will be control group.
~Clinical And Laboratory Parameters Will Be Evaluated For Ovarian Capacity Of These Women.
~Amh Will Be Looked For (Pmol / L). Antral Folukul Census In The Overin Folukular Stage Will Be Valued As Number. Fsh (Iu / L) And Estradiol (Pmol / L) Values Will Also Be Recorded."
15829330|NCT04209868|Drug|Levo-Bupivacaine Hydrochloride (HCl) 0.5 % in 20mL Injection|As per arm description
15829331|NCT04209868|Drug|0.9% Sodium Chloride 20mL Injection|As per arm description
15829336|NCT04209842|Device|gastric balloon|non surgical weight loss via placement of gastric balloon
15829337|NCT04209816|Diagnostic Test|Lipoprotein kinetics|Lipoprotein kinetic apply protocol that endogenously label proteins and fatty acids with stable isotope-labeled amino acid and glycerol tracers. De novo lipogenesis is measured after ingestion of deuterated water to measure newly formed fatty acids in VLDL. Liver fat is measured with magnetic resonance spectroscopy and lipolytic enzymes with heparin test.
15829338|NCT04209803|Drug|Minoxidil 5% topically and oral NAC 600 mg|Topical 5% Minoxidil and N-Acetyl-Cysteine 600 mg orally
15829339|NCT04209790|Radiation|Neoadjuvant chemoradiation|Intensity modulation radiation therapy (IMRT) with a simultaneous integrated boost with Fixed-gantry IMRT, helical tomotherapy, or Vesicular monoamine transporter (VMAT) can be used. All photon treatments shall be delivered with megavoltage machines of a minimum energy of 6 Megavolt (MV) photons. Selection of the appropriate photon energy(ies) should be based on optimizing the radiation dose distribution within the target volume and minimizing dose to non-target normal tissue.
15829340|NCT04209790|Drug|Drug Therapy with Temozolomide (benzolamide) (Standard of Care)|During Concomitant Radiation Therapy on the same day as the first fraction of radiotherapy. Temozolomide will be administered continuously from day 1 of radiotherapy to the last day of radiation at a daily oral dose of 75 mg/m2 for a maximum of 49 days. The drug will be administered orally daily during radiotherapy, as best tolerated by the patient. During weekends without radiotherapy (Saturday and Sunday), the drug will be taken in the morning. The dose will be determined using actual body surface area (BSA) as calculated in square meters at the beginning of the concomitant treatment. The BSA will be calculated from the height obtained at the pretreatment visit. Capsules of temozolomide are available in 5, 20, 100, 140, 180, and 250 mg. The daily dose will be rounded to the nearest 5 mg.
15829341|NCT04209790|Procedure|Surgery post Radiation and Temozolomide (benzolamide)|Surgical resection of GBM will be done after radiation and Temozolomide treatment.
15829342|NCT04209777|Drug|Probiotic Blend Chewable Tablet|Lactobacillus-reuteri probiotics were used as an experimental drug.
15829343|NCT04209777|Drug|Antibiotics|Amoxicillin capsules 500mg and metronidazole tablets 400mg antibiotics were used as an active comparator.
15829344|NCT04209751|Diagnostic Test|Stool removal|Stool removal; freezing an aliquot at -20 ° C and performing a direct examination. DNA extraction and serial PCR (Polymerase chain reaction).
15829345|NCT04209738|Other|This is an observational study being conducted as a substudy of another trial.|This is an observational study being conducted as a substudy of another trial. No intervention is planned for Substudy.
15829346|NCT04209725|Drug|CPX-351|To be given during the induction and consildation phase and will consist of 44 mg/m^2 daunorubicin with 100 mg/m^2 cytarabine administered intravenously on Days 1, 3, and 5 during induction phase and Days 1 and 3 of consolidation phase.
15829347|NCT04209725|Drug|Quizartinib|To be given during induction, consolidation, and maintenance phases and will be taken orally at a dose of 30mg on Days 8-21 of induction phase, Days 6-21 of consolidation phase, and daily in maintenance phase.
15829348|NCT04209712|Biological|haploid allogeneic NK cell therapy|NK cells will be intravenously infused to the patient for 2 days, with following subcutaneously injection of Interleukin-2.
15829349|NCT04209699|Drug|BMS-986165|Single dose
15829350|NCT04209699|Drug|Famotidine|Single dose
15829351|NCT04209686|Drug|Paclitaxel|"Patients will receive treatment on Day 1 and 8 starting with cycle 2.
~Paclitaxel (80 mg) will be administered IV on days 1 and 8 starting with cycle 2 (every 21 days).
~Drug - Paclitaxel - 80mg IV"
15829353|NCT04209686|Drug|Pembrolizumab|"Patients will receive treatment every 21 days.
~Pembrolizumab (200 mg) will be administered IV on day 1 (every 21 days).
~Drug - 200mg IV"
15829354|NCT04209673|Other|Multimodal Pain management including TENS unit|Patient receiving multimodal pain management strategies which includes the use of TENS.
15829355|NCT04209673|Other|Multimodal Pain management not including TENS unit|Patient receiving multimodal pain management strategies which does not includes the use of TENS.
15829356|NCT04209660|Drug|Lenvatinib|Lenvatinib 20mg daily (two 10mg lenvatinib capsules) taken orally will be administered with water orally once a day (with or without food) in 21-day cycles at approximately the same time each day.
15829357|NCT04209660|Drug|Pembrolizumab|Pembrolizumab (200mg) will be administered as a 30-minute IV infusion, Q3W +/-3 days (infusions lasting between 25-40 minutes are acceptable on C1D1.
15829358|NCT04209647|Other|REHIT Exercise|"-Start with warm-up period --> %50 of maximum work rate, 3 minutes
~One Exercise Cycle consists of:
~15 seconds exercise period: %100 of maximum work rate
~15 seconds recovery period: %50 of maximum work rate
~Total Duration: 10 minutes"
15829359|NCT04209647|Other|Continuous Aerobic Exercise|At %50 of maximum heart rate, 30-60 minutes aerobic exercise
15829360|NCT04209634|Drug|Pozelimab|Single loading intravenous (IV) dose on day 1, then fixed doses sub-cutaneous (SC) (based on body weight) QW (±1 day) over the treatment period.
15829361|NCT04209621|Drug|Duvelisib|twice daily as tolerated until disease progression
15829362|NCT04209621|Drug|Ibrutinib|daily for the first six 28-day cycles
15829363|NCT04209595|Drug|PLX038|Phase I: Dose escalation will follow the classical 3+3 trial design by Fibonacci sequence. Phase II: MTD identified in phase I. PLX038 will be administered as a 1 hour (-10 minutes/+30 minutes) IV infusion on Day 1 of each cycle (21 days).
15829364|NCT04209595|Drug|Rucaparib|Phase I: Dose escalation will follow the classical 3+3 trial design by Fibonacci sequence. Phase II: MTD identified in phase I. Rucaparib will be given orally at designated dose twice a day on days 5 to 19 of every 21-day cycle.
15829365|NCT04209582|Device|measurement of TcPO2 with skin electrode|measurement of TcPO2 with skin electrode
15829366|NCT04209569|Behavioral|Nutrition Impact and Positive Practice Circle (NIPP)|GOAL's NIPP approach is a gendered, grass-roots SBC approach, tackling a package of underlying behavioral determinants of malnutrition, irrespective of the particular manifestation. The approach is multi-sectoral in nature. It also has a strong monitoring, evaluation and adaptive learning component by design. The intervention approach (based on GOAL's NIPP approach) involves the creation of community, male and female circles in each community with messaging and activities targeted towards the three groups in varying intensities. While the male and female circles meet 2-3 times per week for a maximum period of 12 weeks while the community circles will meet for approximately three hours at any one time over a period of 2-7 days. (See GOAL NIPP Implementation Guidelines)
15829367|NCT04209556|Drug|PF-06826647 100 mg QD|Investigational Product
15829368|NCT04209556|Drug|PF-06826647 300 mg QD|Investigational Product
15829369|NCT04209556|Drug|PF-06826647 600 mg QD|Investigational Product
15829370|NCT04209556|Drug|Placebo|Matched Placebo
15829371|NCT04209556|Drug|PF-6826647 400 mg QD|Investigational Product
15829372|NCT04209543|Drug|Estetrol oral tablet|Estetrol oral tablet will be administered orally once daily
15829373|NCT04209543|Drug|Placebo oral tablet|Placebo oral tablet will be administered orally once daily
15829374|NCT04209543|Drug|Progesterone oral tablet|Progesterone oral tablet will be administered orally once daily
15829375|NCT04209530|Drug|EN3835|Collagenase Clostridium Histolyticum (CCH)
15829376|NCT04209517|Other|Filming|Behavioural markers selection from video-recordings of the interview
15829377|NCT04209504|Diagnostic Test|Ultrasound|Ultrasound guided evaluation of diaphragm ipsilateral to the block side.
15829378|NCT04209504|Drug|Ropivacaine|Local anesthetic (numbing drug)
15829379|NCT04209504|Drug|Bupivacaine|Local anesthetic (numbing drug)
15829380|NCT04209504|Device|MediPines AGM100 Advanced Respiratory Monitoring System|Non-invasive respiratory monitor to measure oxygenation and ventilation parameters
15829381|NCT04209478|Drug|Tramadol hydrochloride|The Wong-Baker facial pain scale was used to assess pain (1: no pain, 10: worst possible pain). During monitoring patients with pain score ≥3 had intravenous 1 mg/kg tramadol hydrochloride administered, After 15 minutes following tramadol injection, cases with pain score continuing ≥3 were to be assessed as insufficient analgesia and had 0.1 mg/kg morphine hydrochloride planned for intravenous administration
15829382|NCT04209465|Drug|BDTX-189|Participants will receive a daily, oral dose of BDTX-189 as part of a 3 week cycle.
15829383|NCT04209452|Behavioral|Rehearsal strategy|Teaching children to cumulatively rehearse numbers as they are being said.
15829384|NCT04209452|Behavioral|Reinforcement|Providing reinforcement for correct recall after a delay.
15829385|NCT04209452|Behavioral|Rehearsal strategy and reinforcement|Teaching children to cumulatively rehearse numbers as they are being said, AND providing reinforcement for correct recall after a delay.
15829386|NCT04209439|Drug|30 ml %0.25 bupivacaine|Ultrasound-guided erector spinae plane block
15829387|NCT04209439|Drug|Dexketoprofen-trometamol|50 mg Dexketoprofen-trometamol intravenous
15829388|NCT04209426|Device|THA with SYMBOL CUP DMR HA|
15829389|NCT04209426|Device|THA with SYMBOL CUP DM CEM|
15829390|NCT04209413|Procedure|Patients referred for a knee ligamentoplasty|knee ligamentoplasty
15829391|NCT04209400|Biological|Sci-B-Vac®|Sci-B-Vac® vaccine-10 μg of HBsAg, intramuscular injection of 10 μg/ml
15829392|NCT04209400|Biological|Engerix-B®|Engerix-B® vaccine-20 μg of HBsAg, intramuscular injection of 20 μg/ml
15829393|NCT04209374|Device|THA with SYMBOL CUP DM HA|
15829394|NCT04209361|Other|Questionnaire|Data will be obtained through a printed questionnaire for assessment of knowledge, attitude and practice of dentists at military hospitals regarding child abuse and neglect. The collected data will be saved and tabulated on a computer and finally will be statistically analyzed.
15829395|NCT04209348|Behavioral|Physical Activity Intervention|Participants in both arms will wear the CGM (FDA-regulated device)
15829396|NCT04209348|Other|Wellness Education|Participants in both arms will wear the CGM (FDA-regulated device)
15829397|NCT04209335|Other|isometric core muscle endurance testing|holding previously described isometric positions until fatigue
15829398|NCT04209322|Procedure|pulsed Radiofrequency|Non-surgical treatment of lumbar disc herniation causing sciatica using pulsed radiofrequency (10 minutes) directed to the interested dorsal root ganglia (percutaneous technique); after radiofrequency application, using the same needle, steroid was administered (as per the control arm). The procedure was guided by CT imaging
15829399|NCT04209322|Procedure|Transforaminal Epidural Steroid Injection|Percutaneous injection of steroid in the nerve root foramen. The procedure was guided by CT imaging
15829400|NCT04209309|Device|repetitive transcranial magnetic stimulation|
15829401|NCT04209296|Drug|Ketamine Hydrochloride|Ketamine, a N-methyl-D-aspartate (NMDA) receptor antagonist has been used for general anesthesia since the 1970s, however, reports and trials by the end of the twentieth century and onward using subanesthetic doses suggested robust and rapid antidepressant and anti-suicidal effects. Ketamine is available as a 50/50 racemic mixture of enantiomers (S)-ketamine and (R)-ketamine.
15829402|NCT04209283|Behavioral|Visuospatial interference|Behavioral: Brief cognitive intervention. A one-session intervention with a researcher including a simple cognitive task (a memory cue and 25 minutes of Tetris game play with mental rotation) with instructions to engage in the task self-guided in the subsequent weeks.
15829403|NCT04209257|Device|Functional Electrical Stimulation.|Functional electrical stimulation - electrical stimulation applied to a muscle during an activity (i.e. ankle dorsiflexors during swing phase of gait). It assists / elicits muscle activation in order to achieve a task.
15829404|NCT04209244|Dietary Supplement|Eskimo-3 Pure Fish Oil|Dosage: 10 ml/day (2.6 g EPA+DHA)
15829405|NCT04209244|Dietary Supplement|Rapeseed Oil|Dosage: 10 ml/day (0 g EPA+DHA)
15829406|NCT04209231|Other|1.25(OH)2D3|
15829407|NCT04209231|Other|25(OH)D|
15829408|NCT04209218|Drug|Dexamethasone|Dexamethasone (10 mg/2 ml) is administered before anesthesia induction.
15829409|NCT04209218|Other|Targeted blood pressure management|Blood pressure is maintained within ±10% from baseline.
15829410|NCT04209218|Drug|Placebo|Placebo (2 ml normal saline) is administered before anesthesia induction.
15829411|NCT04209218|Other|Routine blood presure management|Blood pressure is maintained according to routine practice.
15829412|NCT04209205|Drug|Secukinumab|Subjects will receive secukinumab i.v. (6 mg/kg) at BSL, followed by secukinumab 3 mg/kg i.v. every four weeks starting at Week 4 through Week 48 (exposure through week 52).
15829413|NCT04209205|Drug|Placebo|Subjects will receive placebo i.v. at BSL, Week 4, 8 and 12 followed by secukinumab 3 mg/kg i.v. every four weeks starting at Week 16 through Week 48 (exposure through week 52).
15829414|NCT04209192|Drug|Fosfomycin Tromethamine 3G Sachet|Is the prophylactic drug which will be used in the intervention group.
15829415|NCT04209192|Drug|Amikacin|Is the prophylactic drug which will be used in the control group.
15829416|NCT04209179|Drug|PCO371|PCO371 capsule
15829417|NCT04209179|Drug|Placebo|Placebo capsule
15829418|NCT04209166|Drug|SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors)|Patients will be treated with Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors.
15829419|NCT04209166|Drug|SSRIs/SNRIs+Mood Stabilizer|Patients will be treated with Mood Stabilizer combined with Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors.
15829420|NCT04209166|Drug|SSRIs/SNRIs+Quetiapine|Patients will be treated with Quetiapine combined with Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors.
15829421|NCT04209166|Drug|Usual Treatment|Patients' treatment will be decided by the clinical doctor.
15829422|NCT04209153|Other|Transcranial Direct Current Stimulation|tDCS sessions (with Direct Transcranial Electrical Stimulation (tDCS) device - Neuroelectrics
15829423|NCT04209140|Drug|lithium treatment|"Decisions relating to treatment are also considered the clinician's responsibility to be made according to bipolar treatment guidelines and international standards of care (e.g. discontinuation, co-prescriptions, and according to SmPC in force). After the clinician has confirmed the indication of Lithium treatment as well as the absence of contra-indicated concomintant medication (NSAIDs and Diuretics) and after pre-
~Lithium evaluations confirm the absence of contra-indication, Lithium is initiated following standard of care:
~progressive titration to reach therapeutic plasma levels. Clinicians will use the therapeutic range provided by the laboratory they use in their usual clinical practice and according to the type of Lithium they prescribe."
15829424|NCT04209127|Procedure|Microwave treatment via needle antenna|Microwave treatment via needle antenna, (Emprint Covidien microwave ablation system) either percutaneous or vaginally administrated
15829425|NCT04209127|Procedure|Embolization of uterine artery or branches thereof (routine treatment where polyvinyl alcohol particles are released into the predefined bloodstream)|Embolization via percutaneous catheter
15829429|NCT04209088|Other|Pulmonary ultrasounds|"Two ultrasounds will be performed by the same pediatrician for each child included: the first at nine days of life +/- two days, the second at fifteen days of life +/- two days.
~A blind replay of ultrasound images to calculate the score will be performed by a another investigator."
15829430|NCT04209075|Dietary Supplement|Biomebliss|BiomeBliss is a commercially available powder containing prebiotic fiber (inulin and Bglucan), along with blueberry extract providing polyphenols.
15829431|NCT04209075|Drug|Metformin|Metformin is a commonly used antidiabetic medication, and the only oral medication approved for children and adolescents under 18 years old. Though reasonably effective, gastro-intestinal side effects are common (80% at initiation, and 10-30% after long term use). Metformin dosing at clinically recommended doses will be titrated per protocol during the study.
15829432|NCT04209075|Dietary Supplement|Placebo|Placebo Comparator
15829433|NCT04209062|Device|Medical device validation|The medical devices will both record electrical signals for comparison
15829434|NCT04209049|Drug|NNC0174-0833|A single subcutaneous (s.c., under the skin) dose of 0.6 mg NNC0174-0833.
15829435|NCT04209036|Other|0° 3D laparoscopy high-definition camera(Olympus Winter & IBE GMBH, Hamburg - Germany)|total laparoscopic hysterectomy using a 3D laparoscopy high-definition system
15829543|NCT04208269|Other|Health Information Technology system|Accessed by adolescent and provider only
15829436|NCT04209023|Device|Transcranial Magnetic Stimulation|Individual pulses (100% motor threshold intensity, continuous temperature of 24 degrees C) will be delivered upon the presentation of the stimulus or the verbal command for the language tasks. Two research coordinators will perform the intervention, with one coordinator presenting the stimulus/giving commands, and the other positioning the TMS coil and delivering the individual pulse or pulse trains. The stimulus presentation will last for a duration of 1 second, in conjunction with the time-course of the pulse's disruption. One or both research coordinators must track the successful or unsuccessful inhibition of task completion for each trial. The number of trials may vary depending on task and region-of-interest; however the intervention is not to exceed a total of 20 minutes.
15829437|NCT04209010|Procedure|one-stage technique|breast reconstruction in one stage using silicone implant and acellular dermal matrix.
15829438|NCT04208997|Drug|Antiarrhythmic drug|Continuation of amiodarone or sotalol.
15829439|NCT04208984|Device|Study|After consent and assent the child and parent will be introduced the Lullabreath in pre-op. The purpose of Lullabreath will be explained and the Lullabreath will be taught (15 minutes). The parent will complete the PROMIS Proxy Anxiety short form. The children are then taken to the operating room (leave parents) with the Lullabreath. The anesthesiologist will hook the device up to the anesthesia circuit and start the Lullabreath. The child will then undergo induction of anesthesia while playing the Lullabreath.
15829440|NCT04208984|Other|Music Video|After consent and assent the child and parent will be introduced to the game in pre-op. The purpose of the game will be explained and the game will be taught (15 minutes). The parent will complete the PROMIS Proxy Anxiety short form. The children are then taken to the operating room (leave parents) with the game. The anesthesiologist will hook the device up to the anesthesia circuit and start the game. The child will then undergo induction of anesthesia while playing the game. The child can choose to watch one of two music videos (Frozen, Lion King)
15829441|NCT04208971|Other|AI-enabled ECG-based Screening Tool for AF|A novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool to improve atrial fibrillation diagnosis and stroke prevention.
15829442|NCT04208958|Biological|VE800|VE800 is an orally administered (PO) live biotherapeutic product (LBP) consisting of 11 distinct nonpathogenic, nontoxigenic, commensal bacterial strains manufactured under GMP conditions. These strains were selected for their ability to induce an immune response.
15829443|NCT04208958|Drug|Nivolumab|Nivolumab is an approved medication that blocks antibodies for certain types of cancer.
15829444|NCT04208958|Drug|Vancomycin Oral Capsule|Vancomycin is an antibiotic used to treat or prevent infection.
15829445|NCT04208945|Drug|Colistin|500000 units of inhaled colistin three times daily for 10 days
15829446|NCT04208932|Drug|SSRIs|Selective Serotonin Reuptake Inhibitors
15829447|NCT04208919|Biological|Donor-derived DCreg|Regulatory dendritic cells that were prepared from a donor leukapheresis will be infused into liver transplant recipients 7 days prior to the start of immunosuppression weaning.
15829449|NCT04208893|Behavioral|Exercise training|See description of Arms
15829450|NCT04208880|Behavioral|TBH Brain Workout 1.0|TBH Brain Workout program with easy challenge activities.
15829451|NCT04208880|Behavioral|Brain Health Book Club|Each week a new chapter will be read that contains new information to enhance brain health.
15829452|NCT04208880|Behavioral|TBH Brain Workout 2.0|TBH Brain Workout program with moderately difficult challenge activities.
15829453|NCT04208880|Behavioral|TBH Memory 1.0|TBH Memory program with easy challenge activities.
15829454|NCT04208880|Behavioral|TBH Memory 2.0|TBH Memory program with moderately difficult challenge activities
15829455|NCT04208867|Behavioral|QI Collaborative|Facilities that participated in a QI collaborative to improve PCC for MH services
15829456|NCT04208854|Drug|Vinorelbine|"Vinorelbine 40 mg (2 cps of 20 mg) three times a week (Monday. Wednesday, Friday), for the first 2 weeks.
~Starting from the third week, in the absence of any severe toxicity (≥ 3) and in the opinion of the clinician, the dosage can be increased to 50 mg (1 cps from 30 + 1 cps from 20 mg), three times a week ( Monday, Wednesday, Friday) continuously.
~The dosage of 40 or 50 mg is continued until progression, patient refusal or unacceptable toxicity (in the clinician's opinion)."
15829457|NCT04208841|Behavioral|Person-Centered Care Quality Improvement Collaborative Sustain|Sustain improvements during QI collaborative focused on PCC
15829458|NCT04208841|Behavioral|Person-Centered Care Quality Improvement Collaborative Spread|Implement change package developed during QI Collaborative
15829459|NCT04208815|Other|Milk Polar Lipids|Effects of the addition of 5 g of milk polar lipids to 20 g milk fat.
15829460|NCT04208815|Other|Milk Fat|Effects of the addition of 20 g milk fat.
15829461|NCT04208802|Other|Use of fluoridated toothpaste|Use of fluoridated toothpaste
15829462|NCT04208802|Other|Wearing of an intraoral device with bovine tooth samples|Wearing of an intraoral device with bovine tooth samples
15829463|NCT04208802|Other|Wearing of an intraoral device with resin samples|Wearing of an intraoral device with resin samples
15829464|NCT04208789|Diagnostic Test|Rapid Molecular Drug-Resistant Tuberculosis Test|"GeneXpert MTB/RIF assay is a nucleic acid amplification (NAA) test which simultaneously detects DNA of Mycobacterium tuberculosis complex (MTBC) and resistance to rifampin (RIF) (i.e. mutation of the rpoB gene) in less than two hours. This system integrates and automates sample processing, nucleic acid amplification, and detection of the target sequences. The primers in the XpertMTB/RIF assay amplify a portion of the rpoB gene containing the 81 base pair core region. The probes are able to differentiate between the conserved wild-type sequence and mutations in the core region that is associated with rifampicin resistance. The output of this procedure is detected, undetected, or indeterminate."
15829503|NCT04208516|Procedure|Continuous Quadratus Lumborum Nerve Block|To be administered to subjects in the active comparator group receiving primary major abdominal surgery.
15829465|NCT04208789|Other|Artificial Intelligent Model|The artificial intelligent model is a model that developed from several associated factors with machine learning and deep learning method in order to classify the possibility of drug-resistant tuberculosis. The Artificial neural network will be built using deep learning software.
15829466|NCT04208789|Diagnostic Test|Drug Susceptibility Test|This procedure uses Löwenstein-Jensen (LJ) medium to determine whether the isolates of M. tuberculosis are susceptible to anti-TB agents. Media containing the critical concentration of the anti-TB agent is inoculated with a dilution of a culture suspension (usually a 10-2 dilution of a MacFarland 1 suspension) and control media without the anti-TB agent is inoculated with usually a 10-4 dilution of a MacFarland 1 suspension. Growth (i.e. a number of colonies) on the agent-containing media is compared to the growth on the agent-free control media. The ratio of the number of colonies on the medium containing the anti-TB agent to the number of colonies (corrected for the dilution factor) on the medium without the anti-TB agent is calculated, and the proportion is expressed as a percentage. Provisional results for susceptible isolates may be read after 3-4 weeks of incubation; definitive results may be read after 6 weeks of incubation. Resistance may be reported within 3-4 weeks.
15829467|NCT04208776|Drug|Propranolol|maximum tolerated dose of propranolol with initial dosage of 20mg once a day and uptitrating every 2nd day by 20 mg.
15829468|NCT04208776|Drug|Midodrine|It will be started at 2.5mg TDS and will be uptitrated every 2nd day to a max of 10mg TDS to attain a MAP of atleast 70mm Hg and then uptitate the beta blocker simulataneously to attain the target heart rate
15829469|NCT04208763|Drug|Imipenem|Inj Imipenem 1gm i.v. TDS
15829470|NCT04208763|Drug|Tigecycline|Inj Tigecycline 100mg stat f/b 50mg i.v. OD
15829471|NCT04208763|Drug|GMCSF|Inj GM-CSF 500mcg s.c. OD
15829472|NCT04208763|Drug|Colistin|Inj Colistin 9 MIU i.v. stat f/b 4.5 MIU i.v. BD
15829473|NCT04208750|Device|Vision R-800 Phoropter|Refraction utilizing the Vision R-800 Phoropter with resulting glasses
15829474|NCT04208750|Device|Standard Phoropter|Refraction utilizing the standard phoropter with resulting glasses
15829475|NCT04208737|Procedure|recruitment maneuver|30 cmH2O pressure 15 seconds
15829476|NCT04208724|Other|Training|Participate in the training program
15829477|NCT04208724|Other|Cancer Screening intervention|Receive cancer screening intervention
15829478|NCT04208724|Other|Survey Administration|Ancillary studies
15829479|NCT04208711|Other|biological sample|whole blood sample
15829480|NCT04208698|Drug|CIN-102 Dose 1|Deuterated domperidone (deudomperidone)
15829481|NCT04208698|Drug|CIN-102 Dose 2|Deuterated domperidone (deudomperidone)
15829482|NCT04208698|Drug|Placebo for CIN-102|Placebo
15829483|NCT04208672|Device|UMindSleep|CPAP titration will be provided for Obstructive Sleep Apneas Syndrome.
15829484|NCT04208659|Procedure|Self-administration of auricular acupuncture without prosthesis|Participants will insert semi-permanent acupuncture needles in their ears without the guidance of a prosthesis
15829485|NCT04208659|Procedure|Self-administration of auricular acupuncture with prosthesis|The same participants who previous self-administered a standardized auricular acupuncture will be given custom-molded prostheses midway through the study to assess how much the prostheses facilitate insertion.
15829486|NCT04208646|Biological|Mesenchymal progenitor cells|Allogenic Adipose tissue-derived mesenchymal progentior cells administrated for intra- articular use
15829487|NCT04208646|Biological|No mesenchymal progenitor cells|No mesenchymal progenitor cells for intra- articular use
15829488|NCT04208633|Procedure|Horizontal placement of the intraocular lens in the capsular bag|The eyes will be randomized (1:1) using a dedicated computer programme prior to the start of the study to have a vertical or horizontal placement of the intraocular lens in the capsular bag. The 0 and 180 degrees will be marked on the slit lamp prior to the surgery. The axes of the IOL will be orientated in reference to the midpoint of the optic haptic junction of the IOL. the fellow eye will receive the opposite placement (horizontal or vertical) of the IOL.
15829489|NCT04208633|Procedure|Vertical placement of the intraocular lens in the capsular bag|The eyes will be randomized (1:1) using a dedicated computer programme prior to the start of the study to have a vertical or horizontal placement of the intraocular lens in the capsular bag. The 0 and 180 degrees will be marked on the slit lamp prior to the surgery. The axes of the IOL will be orientated in reference to the midpoint of the optic haptic junction of the IOL. the fellow eye will receive the opposite placement (horizontal or vertical) of the IOL.
15829490|NCT04208620|Drug|Placebo|Placebo administered subcutaneously
15829491|NCT04208620|Drug|Cotadutide|Cotadutide administered subcutaneously
15829492|NCT04208607|Procedure|Bronchoscopy|Role of bronchoscopy in diagnosis of bronchiectasis
15829493|NCT04208594|Drug|Ivabradine|comparing between both drugs for the effect of hypotensive anesthesia
15829494|NCT04208594|Drug|Propranolol|comparing between both drugs for the effect of hypotensive anesthesia
15829495|NCT04208581|Drug|Yiqi Huoxue Huatan granule|Yiqi Huoxue Huatan granule will be administered twice daily for five days a week for 52 weeks,Tiotropium Bromide Powder for Inhalation will be used once daily (18 μg each time) for 52 weeks, Salmeterol / Fluticasone Powder for Inhalation will be used twice daily (50ug/250ug each time) for 52 weeks, Budesonide / Formoterol Powder for Inhalation will be used twice daily (320ug/4.5ug each time) for 52 weeks.
15829496|NCT04208581|Drug|Placebo Yiqi Huoxue Huatan granule|Placebo Yiqi Huoxue Huatan granule will be administered twice daily for five days a week for 52 weeks,Tiotropium Bromide Powder for Inhalation will be used once daily (18 μg each time) for 52 weeks, Salmeterol / Fluticasone Powder for Inhalation will be used twice daily (50ug/250ug each time) for 52 weeks, Budesonide / Formoterol Powder for Inhalation will be used twice daily (320ug/4.5ug each time) for 52 weeks.
15829497|NCT04208568|Procedure|Laparoscopic cholecystectomy|Four ports laparoscopic cholecystectomy under general anaesthesia
15829498|NCT04208555|Drug|Boric Acid Vaginal Suppository|Boric acid vaginal suppository (600 mg/day) for 14 days
15829499|NCT04208555|Drug|Terconazole Vaginal Suppository|Terconazole 80 mg vaginal suppository daily for 6 days
15829500|NCT04208542|Drug|ESP block|Ultrasound guided Erector spinae block (ESP) will perform.
15829501|NCT04208529|Biological|CTX001|CTX001 infusion
15829502|NCT04208516|Procedure|Continuous Erector Spinae Plane Nerve Block|To be administered to subjects in the active comparator group receiving primary unilateral thoracic surgery.
15829542|NCT04208269|Other|postcard campaign|Post card sent to parent only
15829504|NCT04208516|Procedure|Single Erector Spinae Plane Nerve Block|To be administered to subjects in the experimental group receiving primary unilateral thoracic surgery.
15829505|NCT04208516|Procedure|Single Quadratus Lumborum Nerve Block|To be administered to subjects in the experimental group receiving primary major abdominal surgery.
15829506|NCT04208516|Drug|Lidocaine IV|To be given postoperatively as a continuous infusion at a dose of 50 mg/hr in the experimental group.
15829507|NCT04208516|Drug|Ropivacaine 0.5% Injectable Solution|To be used in both treatment arms as nerve block initial bolus injection.
15829508|NCT04208516|Drug|Dexamethasone|To be used in the experimental arm as a nerve block adjuvant to promote prolonged single block duration, as is standard of care in this institution.
15829509|NCT04208516|Drug|Dexmedetomidine|To be used in the experimental arm as a nerve block adjuvant to promote prolonged single block duration, as is standard of care in this institution.
15829510|NCT04208516|Drug|Lidocaine|To be used perineurally as a 0.25% solution in the active comparator group at a rate of 10 ml/hr per perineural catheter.
15829511|NCT04208503|Diagnostic Test|thyroid ultrasound|After meeting enrolment criteria the thyroid ultrasound will be performed at 32 and 36 weeks of gestation, blood test for TSH and FT4 will be obtained at 14-21 day of life, at 32 and 36 weeks of gestation
15829512|NCT04208490|Other|HN-STAR Intervention|The Head and Neck Survivorship Tool (HN-STAR) is a web-based tool used to assist clinicians in implementing the ACS/ASCO HNC survivorship guidelines.
15829513|NCT04208477|Procedure|one site blockade of the stellate ganglion|Ultrasound guided one site blockade of the stellate ganglion.
15829514|NCT04208464|Drug|Baricitinib|4mg daily for 24 weeks from baseline
15829515|NCT04208464|Drug|Baricitinib|4mg daily for 24 weeks starting after a 12-week treatment delay from baseline
15829516|NCT04208451|Dietary Supplement|Alixir 400 Protect|During 30 days all patients take every day 30ml of Alixir 400 protect
15829517|NCT04208438|Diagnostic Test|BVI Device|Non-Invasive measurement of jugular blood volume using Mespere BVI device
15829518|NCT04208438|Diagnostic Test|Point-of-Care Ultrasound|Point-of-Care ultrasound of external and internal jugular veins
15829519|NCT04208425|Behavioral|Project Personality|"The intervention includes five components: 1. An introduction to the brain, including a lesson on the concept of neuroplasticity, describing how and why our behaviors are controlled by thoughts and feelings in their brains, which have potential for change; 2. Written testimonials from older youths who describe their beliefs that people's personal traits (e.g., sadness, anxiety) are malleable, given the brain's plasticity; 3. Additional vignettes written by older youths, describing times when they used growth mindsets to persevere through social and emotional setbacks; 4. A summary of selected scientific studies suggesting that personality can, and often does, change in positive ways over time; and 5. An exercise in which the participants write notes to younger students, drawing on scientific information to describe the malleability of people's personal traits (i.e., a self-persuasion exercise)."
15829520|NCT04208425|Behavioral|Sharing Feelings Intervention|The ST SSI is designed to control for nonspecific aspects of intervention, including engagement in a computer program. It includes the same number of reading and writing activities as the web-based growth mindset intervention; it also mirrors the web-based growth mindset intervention as closely as possible, including vignettes written by older youths who describe times when they benefited from sharing their feelings with friends or family.
15829521|NCT04208412|Drug|KVD900|KVD900 tablet
15829522|NCT04208412|Drug|Placebo|Placebo to KVD900 Tablet
15829523|NCT04208399|Drug|JNJ-56136379|JNJ-56136379 will be administered orally in fed condition.
15829524|NCT04208386|Drug|JNJ-73763989|JNJ-73763989 will be administered SC under fasted condition.
15829525|NCT04208373|Drug|JNJ-64417184|JNJ 64417184 tablets will be administered orally.
15829526|NCT04208373|Drug|Itraconazole|Itraconazole capsules will be administered orally
15829527|NCT04208373|Drug|Etravirine|etravirine tables will be administered orally.
15829528|NCT04208360|Device|StethoMe stethoscope|Assessing whether use of the StethoMe AI lung sounds analysis software provides clinical benefit by improving the identification of abnormal lung sounds.
15829529|NCT04208347|Drug|Apatinib 250mg|Apatinib 250mg
15829530|NCT04208347|Drug|Camrelizumab|Camrelizumab 200mg
15829531|NCT04208347|Drug|S-1, Oxaliplatin|S-1, Oxaliplatin, q3w
15829532|NCT04208347|Drug|Apatinib 500mg|Apatinib 500mg
15829533|NCT04208334|Dietary Supplement|Curcumin|We give an Intervention arm to consume Curcumin 4000mg/day for 60 consecutive days.
15829534|NCT04208334|Other|Placebo|We give a control arm to consume placebo for 60 consecutive days.
15829537|NCT04208308|Dietary Supplement|Chia seeds supplementation (25 g)|Dosage: 1 daily dose energy 498,75 kJ / 118,75 kcal, protein 3,25 g, carbohydrates 9 g, fiber 6 g, fats 6,5 g, Calcium 160 mg Phosphorus 247,5 mg Kalium 37,5 mg Natrium 5,25 mg Zincum 0,975 mg Manganum 0,625 mg Omega-3 fatty acids 4,475 g Omega-6 fatty acids 1,475 g Vitamin B1 0,1 mg Vitamin B2 0,0075 mg Vitamin B3 0,75 mg Vitamin C 0,2 mg
15829538|NCT04208308|Dietary Supplement|Chia seeds supplementation (15 g)|Dosage: 1 daily dose energy 299 kJ / 71,2 kcal, protein 1,95 g, carbohydrates 5,4 g, fiber 3,6 g, fats 3,9 g, Calcium 96 mg Phosphorus 148,5 mg Kalium 22,5 mg Natrium 3,15 mg Zincum 0,59 mg Manganum 0,375 mg Omega-3 fatty acids 2,684 g Omega-6 fatty acids 0,885 g Vitamin B1 0,06 mg Vitamin B2 0,0045 mg Vitamin B3 0,45 mg Vitamin C 0,12 mg
15829539|NCT04208308|Dietary Supplement|Combine supplementation: chia seeds (15g) and fish oil Maxi Cor 70+20|"Chia seeds - 1 daily dose Fish oil TID
~Chia seeds supplementation (15 g) and fish oil supplementation (pharmacological supplement) - Maxi Cor 70+20 (EPA 675 mg +DHA 510 mg)
~On dose (15g) of chia seeds contains:
~energy 299 kJ / 71,2 kcal, protein 1,95 g, carbohydrates 5,4 g, fiber 3,6 g, fats 3,9 g, Calcium 96 mg Phosphorus 148,5 mg Kalium 22,5 mg Natrium 3,15 mg Zincum 0,59 mg Manganum 0,375 mg Omega-3 fatty acids 2,684 g Omega-6 fatty acids 0,885 g Vitamin B1 0,06 mg Vitamin B2 0,0045 mg Vitamin B3 0,45 mg Vitamin C 0,12 mg"
15829540|NCT04208308|Dietary Supplement|Fish oil supplementation|"TID
~Daily dose:
~Fish oil supplementation (pharmacological supplemment) - Maxi Cor 70+20 (EPA 825 mg +DHA 525 mg)"
15829541|NCT04208282|Device|7 day infusion set|7 days survival of the sets
15829545|NCT04208243|Behavioral|Creative Arts Therapy|"The intervention will consist of approximately weekly CAT in the infusion center during cancer therapy. The interventionist is a Master's prepared, licensed dance/movement therapist who is experienced in music and art therapies as well. The CAT includes dance/movement such as playing with a parachute, simple yoga breathing and postures, and work with physioballs. The music includes singing, listening to music, and playing instruments. The art consists of drawing, finger painting, working with clay. The CAT may occur in individual sessions in private infusion rooms, or in groups in the middle of the infusion center. The CAT is not only a distraction, but also a therapeutic process addressing the stressors of cancer and its treatment. The dose of CAT will be recorded (number and type of sessions) and will be factored into the analysis."
15829547|NCT04208217|Behavioral|Modeling to Learn (MTL)|Modeling to Learn is a facilitated health care quality improvement or evidence-based practice implementation strategy that includes frontline addiction and mental health staff running simulations of clinic improvement strategies to find the best approaches for improving the reach of evidence-based psychotherapy and evidence-based pharmacotherapy.
15829548|NCT04208217|Behavioral|Usual quality improvement (QI)|Usual quality improvement is a health care quality improvement or evidence-based practice implementation strategy that includes frontline addiction and mental health staff reviewing data to find the best approaches for improving the reach of evidence-based psychotherapy and evidence-based pharmacotherapy.
15829549|NCT04208204|Other|somatocognitive physiotherapy|Somatocognitive physiotherapy (SCT) is a multimodal physical therapy approach that has been developed in an attempt at alleviating the burden of longstanding pain. The main foci of SCT include: (1) bodily exercises and techniques increasing body awareness, ability to relax and control muscle tension in different situations; (2) education about the vulvodynia and factors influencing pain experience; (3) coping with emotions and thoughts related to bodily experiences; and (4) structured homework assignments promoting application of the learned techniques in daily situation and gradual exposure to activities associated with pain. An important goal of SCT is to facilitate integration of new bodily habits into the patient's daily activities. The most important learning process thus occurs in the space between the treatment sessions. The therapeutic techniques are to be rehearsed in everyday situations.
15829550|NCT04208191|Behavioral|Quality Improvement Collaborative|Facilities that participated in a QI collaborative to improve PCC for MH and FP services
15829551|NCT04208178|Drug|Alpelisib|Alpelisib - continuous once daily, in a 21-day cycle
15829552|NCT04208178|Drug|Alpelisib matching Placebo|Alpelisib matching placebo: continuous once daily, in a 21-day cycle
15829553|NCT04208178|Drug|Trastuzumab|Trastuzumab - Day 1 of Cycle 1, and on Day 1 (+/- 3 days) of every cycle thereafter
15829554|NCT04208178|Drug|Pertuzumab|Pertuzumab - Day 1 of Cycle 1, and on Day 1 (+/- 3 days) of every cycle thereafter
15829555|NCT04208165|Other|ultrasound-guided nerve block PVB|Thoracic paravertebral block guided by ultrasound device which allows visualizing the surrounding anatomy and placement of the needle at the target location in real time.
15829556|NCT04208165|Other|ultrasound-guided nerve block TAB|Transverse abdominis plane block guided by ultrasound device which allows visualizing the surrounding anatomy and placement of the needle at the target location in real time.
15829557|NCT04208152|Drug|anle138b|capsule containing excipient and anle138b
15829558|NCT04208152|Drug|Placebo|matching placebo capsule containing excipient
15829559|NCT04208139|Diagnostic Test|IVUS|IVUS
15829560|NCT04208126|Device|ECMO|ECMO implantation immediately after ICU admission
15829561|NCT04208113|Behavioral|School teacher training /.b|"The intervention is a multi-level, multi-component complex intervention. It consists of a school teacher training programme and the .b-programme to be delivered to pupils 11-15 years in the schools.
~The school teacher training programme consists of three parts: 1) the establishment of own mindfulness practice by participation in the MBSR programme and sustaining mindfulness with a regular formal daily practice; 2) completion of the four days .b residential course, and 3) completion of the 3x2-days seminars on relational competences and implementation issues regarding teaching .b .
~The .b programme consists of well-described, weekly 40-60 minutes classroom sessions over 10 weeks. All the sessions have a specific theme, associated teachers' notes, power points and animations. The .b programme can only be delivered with fidelity by a trained .b teacher."
15829562|NCT04208100|Device|PicoPlus|The PICOPLUS Laser System (K173700) is indicated for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. The 595nm and 660nm wavelengths of the Lutronic PicoPlus Laser system are used for the treatment of benign pigmented lesions.
15829563|NCT04208087|Drug|SI-722|SI-722 will be intravesically instilled.
15829564|NCT04208087|Drug|Placebo|Placebo will be intravesically instilled.
15829565|NCT04208074|Other|Exercise Intervention|Participants will exercise under the supervision of expert personal trainers and follow an optimized exercise program tailored to the strength and fitness level of each participant. Participants will exercise for 16 weeks; 2 days a week at the gym for an hour and 2 days of the week at home for 45 minutes.
15829566|NCT04208061|Drug|Dabigatran Etexilate|Participants will receive single dose of dabigatran etexilate orally.
15829567|NCT04208061|Drug|DRV/COBI|Participants will receive oral tablet of fixed dose combination (FDC) containing darunavir (DRV)/ cobicistat (COBI).
15829568|NCT04208061|Drug|Ritonavir|Participants will receive ritonavir orally.
15829569|NCT04208061|Drug|Darunavir|Participants will receive Darunavir orally.
15829570|NCT04208048|Device|FLXfit 15TM device|In order to implant the FLXfit 15TM device properly, your study doctor will first prepare the space between the low back bones (vertebrae) and then remove your damaged disc. The FLXfit 15TM device will then be placed into the space between the low backbones, using specific medical instruments, where the damaged disc was removed.
15829571|NCT04208022|Other|Respiratory evaluation|Hypermobility and Respiratory evaluation
15829572|NCT04208009|Behavioral|Advance care planning animated videos|Four advance care planning videos: 1) Description of ACP; 2) Explanation of the importance of engaging in ACP now; 3) Communicating wishes to one's loved ones and family members; and 4) Communicating wishes to one's doctor.
15829573|NCT04207983|Combination Product|EYS606|EYS606 is a DNA plasmid solution administered by electrotransfection into the ciliary muscle
15829574|NCT04207970|Other|Adapted Structured Clinical Management|Adapted form of a previous Evidence Based Treatment- adapted to local context, in light of input from service-users and commissioners.
15829575|NCT04207957|Drug|Olorofim|150 mg
15829576|NCT04207944|Drug|Sulindac 400 MG|Patients will be randomized to receive standard radiographic/endoscopic surveillance plus sulindac. The sulindac starting dose is 200 mg by mouth 2x daily. Randomization will be performed at Duke and stratified by (1) the presence of high-grade dysplasia on the operative pathologic report and (2) the use of metformin at the time of enrollment. Patients will be provided the study drugs by a Duke, MSK, MGH, or JHH pharmacist. Patients will continue drug/placebo for 3 years during follow-up.
15829577|NCT04207944|Other|Placebo|Patients will be randomized to receive standard radiographic/endoscopic surveillance plus sulindac. The sulindac starting dose is 200 mg by mouth 2x daily. Randomization will be performed at Duke and stratified by (1) the presence of high-grade dysplasia on the operative pathologic report and (2) the use of metformin at the time of enrollment. Patients will be provided the study drugs by a Duke, MSK, MGH, or JHH pharmacist. Patients will continue drug/placebo for 3 years during follow-up.
15829585|NCT04207905|Other|Healthy Michigan Plan (HMP) coverage with work requirements|For those who are not in the Exempt for Research Purposes group, to be eligible for HMP coverage beginning January 1, 2020, enrollees ages 19-62 must report 80 hours per calendar month of community engagement activities, such as employment, education, job training, job search activities, participation in substance use disorder (SUD) treatment, or community service.
15829586|NCT04207892|Procedure|Conservative (non-surgical) treatment|Cast Sling Splint Collar
15829587|NCT04207892|Procedure|Surgical treatment|Elastic Stable Intramedullary Nailing (ESIN) K-Wire External fixation
15829588|NCT04207866|Other|Teleconferencing|Use of video/audio stream to provide auditory training at a remote site.
15829589|NCT04207866|Other|Auditory training services|"Participants will engage in regular visits with a specialist to: 1) facilitate auditory training exercises; 2) work with the family/friends to encourage optimal communication strategies in the home; 3) evaluate and assess achievement of listening goals.
~Auditory training assess/reviews skills associated with but not necessarily limited to: 1) developing strategies to repair communication breakdowns; 2) listening in quiet; 3) listening in noise; 4) listening to a degraded signal."
15829590|NCT04207853|Other|whole body vibration em DM|The vibrating platform is a new biophysical modality of exercise. The individual exercises on a plate that oscillates up and down movements at a specific frequency and amplitude, and the exercises are performed static and / or dynamic. Vibration is supposed to activate muscle spindles and evoke contractions, which are induced by the complex spinal and supraspinal neurophysiological mechanism known as the tonic vibration reflex.
15829591|NCT04207853|Other|"Vibration sham em DM"|Sham vibration will be performed with the platform disconnected. A sound device will be connected producing a noise similar to the connected platform for a time equivalent to the treatment protocol, as it will not be possible to visibly distinguish the vibratory stimulus. Participants who will undergo false vibration will not have contact with those who will perform the protocol effectively.
15829592|NCT04207853|Other|whole body vibration em NDM|The vibrating platform is a new biophysical modality of exercise. The individual exercises on a plate that oscillates up and down movements at a specific frequency and amplitude, and the exercises are performed static and / or dynamic. Vibration is supposed to activate muscle spindles and evoke contractions, which are induced by the complex spinal and supraspinal neurophysiological mechanism known as the tonic vibration reflex.
15829593|NCT04207853|Other|"Vibration sham em NDM"|Sham vibration will be performed with the platform disconnected. A sound device will be connected producing a noise similar to the connected platform for a time equivalent to the treatment protocol, as it will not be possible to visibly distinguish the vibratory stimulus. Participants who will undergo false vibration will not have contact with those who will perform the protocol effectively.
15829594|NCT04207840|Combination Product|Epinephrine (0.125 mg/inhalation)|Participants will self-administer 2 inhalations of Epinephrine (0.125 mg/inhalation) for a total dosage of 0.25 mg.
15829595|NCT04207840|Combination Product|Epinephrine Injection Auto-Injector (0.3mg/0.3mL)|Participants will receive an intramuscular injection of Epinephrine via Auto-Injector (0.30 mg of epinephrine solution in 0.30 mL). The 0.30 mL dose will be given perpendicularly as a single deep intramuscular injection into the anterolateral aspect of the thigh.
15829596|NCT04207840|Combination Product|Albuterol Sulfate (0.09 mg/inhalation)|Participants will self-administer 2 inhalations of Albuterol Sulfate (0.09 mg/inhalation) for a total dosage of 0.18 mg.
15829597|NCT04207827|Behavioral|xSmoker app|xSmoker - mHealth intervention consisted of using the app xSmoker
15829598|NCT04207827|Behavioral|SMS|Text messages with content based on the Motivation and Problem Solving approach and informed by our prior work.
15829599|NCT04207827|Other|Usual Care|Usual postnatal care
15829600|NCT04207814|Biological|biological sample|biological samples will be taken from the subjects included
15829601|NCT04207801|Drug|AUR101|Inhibitor of RORγ
15829602|NCT04207801|Drug|Matching Placebo|Drug-Placebo of AUR101 tablet
15829770|NCT04206384|Device|Ultrasound|Ultimate Contour Body Sculpting Device
15829603|NCT04207788|Other|HIP-REP|HIP-REP programme is an add on to usual care which includes 5 add on individual activity-focused interventions that will be tailored to the need of elderly with hip fracture in a liaison with the health care professionals. Home visits and follow-up phone call will be a part of programme.
15829604|NCT04207788|Other|Usual care|The elderly in the control group will receive usual rehabilitation. with a focus on mobilization within 24 hours postoperative as an in-patient. In the municipality physiotherapy is offered twice a week for approximately 12 weeks postoperative focusing on neuromotor control over hip, activation and strengthening of muscles as well as increase mobility. When relevant, the elderly receives a home visit by an occupational therapist who assess ADL behaviours, the use of assistive devices and the environmental hazards, preparing and adapting the home environment to prevent falls.
15829605|NCT04207762|Diagnostic Test|18F-AmBF3-TATE PET/CT|Blood pressure, heart rate, and oxygen saturation levels and EKG monitoring (vital signs) will be recorded prior to the injection and at three other stages of the scan visit. Each study subject will have an intravenous catheter inserted. Prior to the radiotracer injection an ultra low dose CT will be taken. Subjects are positioned supine, arms down. The subject will receive a bolus intravenous dose of the radiotracer from an approved study supplier site. A Dynamic PET scan will be taken of the heart. Then a serial whole body PET scan will be done. Vital signs will be taken again and the subject will have a bathroom break. The patient will return to the scanner bed for a standard low dose CT and whole body PET scan. Vital signs will be taken again, and subject will be allowed to use the washroom again. The subject will return to the scanner bed for the final time for an ultra low dose CT and whole body PET scan. A final set of vitals will be taken and the subject will be discharged.
15829606|NCT04207762|Diagnostic Test|Routine blood draw|Complete blood counts and routine clinical chemistry performed before and repeated within 18-72 hours after [18F]AmBF3-TATE administration.
15829607|NCT04207736|Drug|Reproxalap Ophthalmic Solution (0.25%)|Reproxalap Ophthalmic Solution (0.25%) dosed in the Environmental Exposure Chamber.
15829608|NCT04207736|Drug|Vehicle Ophthalmic Solution|Vehicle Ophthalmic Solution dosed in the Environmental Exposure Chamber.
15829609|NCT04207723|Other|Transcutaneous posterior tibial nerve stimulation|Three (3) sessions per week per twelve (12) consecutive weeks, with a duration of 30 minutes each, with the application of 20 Hertz with a pulse amplitude of 200 MI sec. in each session. The intensity will be applied individually for each patient depending on the tolerance of the individual.
15829610|NCT04207723|Drug|Paroxetine|paroxetine 20 mg / day taken in the morning hours, per 12 weeks.
15829611|NCT04207710|Drug|Gebauer Pain Ease Top Aerosol Mist Spray|Topical numbing spray
15829612|NCT04207710|Drug|Gebauer Ethyl Chloride|Topical numbing spray
15829613|NCT04207697|Biological|Beltavac® Polymerized with cat dander|Adminstration of Beltavac® Polymerized with cat dander according to the routine clinical practice
15829614|NCT04207684|Drug|Testosterone injection|250 mg of testosterone cypionate (equivalent to 174,8 mg of testosterone) administered via intramuscular injection in a single dose (2 mL)
15829615|NCT04207671|Procedure|Complete omission of chest tube|No chest tube implacement
15829616|NCT04207671|Procedure|Improved drainage strategy|A two-lumen central venous catheterization along the midclavicular line, second intercostal space for remedial gas-remove
15829617|NCT04207658|Behavioral|Valsalva's Style Pushing|The second stage of labour is defined as the time passed after the cervical dilatation reaches 10cm. The expulsion stage is the time between the sight of baby's head in the vulva and the end of labour. the participants are given information about the study after self introduction of each gravid is done for completing baseline obstetric data forms by midwives. Also, blood samples for pre and postpartum haemoglobin level changes are collected. The perineal area is examined for postpartum tears through pad checks. Vital findings (respiration, pulse and TA) are evaluated prior to their transfer to the delivery room. Just after the birth, mothers are tested for pH, pO2, pCO2 and lactate levels in blood while the newborns are tested for pH, pO2 (mmHg) and pCO2 levels through umbilical artery along with 1st min and 5 min APGAR analysis. The visual scale is utilized for determination of first 24-hour fatigue and they are recorded in follow-up forms.
15829618|NCT04207645|Diagnostic Test|Modified RIPASA score|Clinical Prediction Rules consist of clinical and laboratory parameters to aid diagnosis of acute appendicitis
15829619|NCT04207632|Drug|Botulinum toxin type A injection|Ultrasound-guided BoNT-A injection in biceps brachii or brachialis
15829620|NCT04207619|Other|hyperinsulinemic-hypoglycemic clamp|An intravenous catheter will be placed in an antecubital vein for infusion of insulin and glucose. A second catheter will be placed retrograde in a dorsal vein of the contra-lateral hand for blood withdrawal. The hand will be placed in a heating box or pad at 70°C for arterialization of venous blood. A primed infusion of regular insulin (120 mU/min/m2) will be initiated and continued for approximately 2 hours. Beginning 20 minutes prior to the start of the insulin infusion, arterialized venous blood glucose will be measured at 5 minute intervals via a Hemocue or YSI analyzer. Following initiation of insulin infusion, blood glucose will be allowed to fall to 50 mg/dL and then maintained at this level using a variable infusion of exogenous dextrose (20% solution). Our goal is to achieve steady-state (blood glucose stabilized at 50 +/- 5 mg/dL) within the first 45 minutes following the start of insulin infusion.
15829621|NCT04207619|Other|13C-MRS procedure/Acetate infusion|Glial metabolism will be measured via MRS utilizing a simultaneous intravenous infusion of 13C labeled acetate. An intravenous catheter will be placed in a vein of each arm, one to infuse 13C-acetate and the other to draw blood samples
15829622|NCT04207606|Behavioral|Post Epidural Steroid Injection Follow-up|All enrolled patients will undergo epidural steroid injection with fluoroscopy per the Spine Intervention Society guidelines as part of their normal care. Patients will then be contacted for survey responses every 3 days for a maximum of 23 days, to assess pain intensity and change.
15829623|NCT04207593|Drug|Oxygen|Study medication will be oxygen (O2) in diverse concentrations, titrated until a SaO2>90% or pO2 >60 mmHg is achieved, for 20 patients vs. no supplemental O2 for 20 patients over 90 ± 7 days. Patients of the control group will be offered to participate in the interventional treatment arm after they have terminated the control period (partial cross-over; secondary intervention group). After the end of the study it is up to the judgment of the investigator to prescribe oxygen to all patients who might benefit from the treatment.
15829771|NCT04206371|Diagnostic Test|Defibrillator threshold testing|Under general or local anesthesia. Induction of Ventricular Fibrillation or R-wave synchronized shock
15829624|NCT04207580|Other|Inclusion and follow up of pediatric patients with an idiopathic nephrotic syndrome,|"The study consists in collecting clinical, biological, psychological and social data of INS pediatric patients.
~A bio collection is also created: blood, urine, hair and nails will be collected at the beginning of the INS (before starting immunosuppressive treatment)."
15829625|NCT04207567|Behavioral|Bodyweight exercises (push-ups, angled-rows, bodyweight squats) on weekdays|Participants will be instructed to perform one set each of push-ups, angled-rows, and bodyweight squats every weekday. They will be given the equipment and training necessary to properly perform the exercises. They will also be trained in the Tiny Habits® Method and receive digital coaching.
15829626|NCT04207554|Device|Test Device-Strip Format|Sponsor's investigational device
15829627|NCT04207554|Device|Test Device-Cassette Format|Sponsor's investigational device
15829628|NCT04207554|Device|Predicate Device|Commercially available device
15829629|NCT04207541|Behavioral|Brief motivational interview|Client (who has suboptimal diabetic control with oral anti-diabetic agent) will be advised for insulin initiation with brief motivational interviewing in one session of individual education.
15829630|NCT04207528|Behavioral|Writing|After completing the baseline questionnaire, participants will be randomized to one of two conditions-a peer helping condition or a facts-only writing control. Participants will receive general instructions for completing the writing sessions and will be asked to write for at least 5 minutes per session. Topics covered in each session will vary and are related to common themes relating to life as a first-year university student (e.g., academics, adjusting to university, etc.). Participants will be instructed not to worry about grammar, spelling, or sentence structure and reminded that their responses will remain anonymous. Writing sessions (four in total) will be spaced 1 day apart and take place all within the same week.
15829631|NCT04207515|Procedure|Procedures of wisdom tooth removal surgery under conscious sedation|The first specimen of saliva was taken at the first time patient came to clinic (t1). Saliva was allowed to flow in the floor of mouth an 1 ml was then collected using a Pasteur pipette. First day after examination, patient was given an appointment. The second time of the saliva was taken was when the patient sat in the chair for extraction (t2). The other times of saliva samples were taken were before local anesthesia (t3), immediately after extraction (t4) and at 4 h after extraction (t5). Due to the localization and position of the third molar, osteotomy was performed using a 20,000-rpm hand piece under irrigation for all patients. Some cases required tooth sectioning. 3-0 silk suture was used at the end of the surgery.
15829632|NCT04207515|Procedure|Procedures of wisdom tooth removal surgery under local anesthesia|The first specimen of saliva was taken at the first time patient came to clinic (t1). Saliva was allowed to flow in the floor of mouth an 1 ml was then collected using a Pasteur pipette. First day after examination, patient was given an appointment. The second time of the saliva was taken was when the patient sat in the chair for extraction (t2). The other times of saliva samples were taken were before local anesthesia (t3), immediately after extraction (t4) and at 4 h after extraction (t5). Due to the localization and position of the third molar, osteotomy was performed using a 20,000-rpm hand piece under irrigation for all patients. Some cases required tooth sectioning. 3-0 silk suture was used at the end of the surgery.
15829633|NCT04207489|Procedure|endoscopic submucosal injection of indocyanine green before laparoscopic radical operation of colorectal cancer|Indocyanine green was injected under endoscope within 24 hours before operation. Four points were evenlyinjected in four quadrants at the edge of the tumor. The patients with obstruction were injected at two points on the anal side of the tumor. The diluted concentration of indocyanine green was 0.625mg/ml or 1.25mg/ml. The injection method was direct submucosal injection and sandwich method. According to the imaging effect, it can be divided into local imaging and lymphatic drainage imaging. Tumor body: 0, no imaging; 1, full imaging; 2, diffuse imaging, overflow, interference with other areas of observation. Lymph drainage area imaging 0, no imaging; 1, full imaging; 2, diffuse imaging, overflow, interference with other areas of observation.
15829634|NCT04207476|Device|EMF|Active magnetic field exposure will be performed by use of a EMF resonator. Stimulator will be applied continuously for 1 hour.
15829635|NCT04207476|Device|Placebo|No magnetic field exposure will be given while patients are assigned to this arm for a duration of 1 hour.
15829636|NCT04207463|Drug|AK105|AK105 is a humanized monoclonal antibody that specifically binds to PD-1. AK105 has a typical antibody structure and is composed of two lgG1 subtype heavy chains and two kappa subtypes light chains covalently linked by disulfide bonds.
15829637|NCT04207463|Drug|Anlotinib|a multi-target receptor tyrosine kinase inhibitor
15829638|NCT04207450|Other|Placebo gel|Placebo gel application followed by placebo solution application (distilled water)
15829639|NCT04207450|Other|Placebo Gel + 5% Glutaraldehyde Aqueous Solution|Placebo gel followed by 5% aqueous glutaraldehyde solution
15829640|NCT04207450|Other|Phosphoric Acid 37% + Solução aquosa de glutaraldeído a 5%|37% phosphoric acid application followed by 5% aqueous glutaraldehyde solution
15829641|NCT04207437|Device|Vibration therapy|vibration therapy using hand held vibration device
15829642|NCT04207424|Procedure|Emblization of the gastro-epiploic arcade|Endovascular embolization of the gastro-epiploic arcade using 300-500 micrometres calibrated polyvinyl-alcohol microparticles
15829643|NCT04207411|Drug|Bupivacaine|Injection of anesthetics blocks once a week during 4 weeks.
15829644|NCT04207411|Drug|Lidocaine|Injection of anesthetics blocks once a week during 4 weeks.
15829645|NCT04207398|Procedure|Transjugular intrahepatic portosystemic shunts|Transjugular intrahepatic portosystemic shunt (TIPS) is a procedure that uses imaging guidance to connect the portal vein to the hepatic vein in the liver. A small metal device called a stent is placed to keep the connection open and allow it to bring blood draining from the bowel back to the heart. TIPS may successfully reduce internal bleeding in the stomach and esophagus in patients with cirrhosis and may also reduce the accumulation of fluid in the abdomen (ascites).
15829697|NCT04207047|Device|LaseMD Flex|There are two new versions of the LaseMD system to be used in this study that are uncleared and investigational use only. The only change from the cleared system to the one of the LaseMD systems to be used in this study is that the watts have been increased to 20W and a new tip configuration with a larger 250+ um spot size. The other LaseMD system to be used in this study is the LaseMD FLEX. It also has 20W with larger spot size, a modified flat-top beam profile (as opposed to a Gaussian beam profile) and a faster scan rate. All other technical specifications remain the same as the cleared device.
15829852|NCT04205838|Drug|Cyclophosphamide|Given via infusion
15829646|NCT04207398|Other|Nonselective β-blocker (NSBB)+ endoscopic band ligation (EBL)|Combination therapy of nonselective β-blocker (NSBB) and endoscopic variceal ligation (EBL) will be used for participants in this group. NSBB, which will be titrated to the maximum tolerated dose aiming to decrease the heart rate by 25%, with a lower limit of 50 beats per minute, was started at day 5 after the index bleeding, unless a contraindication was present (severe arrhythmia, severe obstructive chronic obstructive pulmonary disease, or known intolerance). Endoscopic variceal ligation sessions started 2 weeks after the index bleeding and were performed every 2-4 weeks thereafter until eradication of varices, followed by endoscopic surveillance and retreatment, if indicated, every 6-12 months.
15829647|NCT04207385|Diagnostic Test|pharmacogenomics|pharmacogenomics
15829648|NCT04207385|Diagnostic Test|pharmacogenomics & therapeutic drug monitoring|pharmacogenomics & therapeutic drug monitoring
15829649|NCT04207385|Drug|Venlafaxine|Venlafaxine hydrochloride sustained-release capsules 75mg x 14 tablets x 1 case 75-225mg/morning
15829650|NCT04207372|Dietary Supplement|whey protein isolate|whey protein isolate
15829651|NCT04207372|Dietary Supplement|Zein|zein protein
15829652|NCT04207372|Other|protein-free|protein free
15829653|NCT04207359|Dietary Supplement|Creatine|Those randomized to receive creatine (experimental group) will be initially dosed at 20 g/day for 7 days to boost availability of creatine systemically. Thereafter, the dose will be reduced to 5 g/day for maintenance through the duration of the 12-week protocol.
15829656|NCT04207333|Behavioral|Mental Arithmetic Test|The researcher will call out a four-digit number and ask the participant to subtract either 7 or 13. Each minute, a new four-digit number will be called out and the participant must subtract the 7 or 13 from the number. The test will last approximately 5 minutes
15829657|NCT04207320|Device|αβ+ T-cell depletion with Miltenyi CliniMACS system|Haploidentical CD34+ megadose hematopoietic stem cell transplant in which cells are purified using the Miltenyi CliniMACS system designed for αβ+ T-cell receptor selection using immunomagnetic beads.
15829658|NCT04207307|Behavioral|Multimodal exercise program|Multimodal exercise intervention (machine-based resistance, coordination and endurance training).
15829659|NCT04207307|Behavioral|Usual Care|General recommendations for healthy ageing, no machine-based strength training intervention.
15829660|NCT04207294|Other|Pork arm|The effect of 1 portion of vitamin D-enriched pork on 25(OH)D concentration in comparison to a vitamin D supplement and control pork.
15829661|NCT04207294|Other|Chicken arm|The effect of 1 portion of vitamin D-enriched chicken on 25(OH)D concentration in comparison to control chicken.
15829662|NCT04207281|Dietary Supplement|Raw Honey|Canada #2 white raw honey (1.5 tablespoons) supplied by SweetHeart Pollinators (Janeil Enterprises, Eatonia, SK) administered for 7 days
15829663|NCT04207281|Dietary Supplement|Comparator|Honey comparator(1.5 tablespoons) administered for 7 days
15829664|NCT04207268|Behavioral|Gardening and Nutrition Advice|Participate in gardening activities, gardening instructions and nutrition advice
15829665|NCT04207268|Behavioral|Nutrition Advice|Participate in only nutrition advice
15829666|NCT04207255|Drug|Opaganib|500mg of Opaganib orally twice a day continuously.
15829667|NCT04207255|Drug|Abiraterone|IV as directed by SOC
15829668|NCT04207255|Drug|Enzalutamide|IV as directed by SOC
15829669|NCT04207255|Drug|Opaganib|250mg of Opaganib orally twice a day continuously.
15829670|NCT04207229|Device|CODMAN CERTAS Programmable Valves|Patients will undergo implantation of the CODMAN CERTAS Plus Programmable Valve according to the device label.
15829671|NCT04207203|Combination Product|sodium zirconium cyclosilicate and healthy diet|During 3 weeks, SZC will be prescribed to normalize plasma potassium to 3.5 to 5.0 mml/L, and a diet with energy 25-35 kcal/kg/day and protein 0.6 to 0.8 g/kg/day and with low K content will be prescribed. At the end of the first 3 weeks, the patients will initiate a healthy diet containing 3700 to 4000 mg/potassium for 3 weeks (healthy diet phase). A food basket containing fruits, vegetables, whole grains, nuts, white meat, fish and eggs in amounts adequate for the patient will be provided. Serum K will be monitored to promote serum K between 3.5 to 5.0 mmol/L and adjustments in the dose of SZC will be performed according to the drug label. During stabilization and healthy diet phases, serum K will be measured every 72 hours until serum K is normalized and after that, once per week.
15829672|NCT04207190|Drug|Gemtuzumab Ozogamicin|Given IV
15829673|NCT04207190|Other|Quality-of-Life Assessment|Ancillary studies
15829674|NCT04207190|Other|Questionnaire Administration|Ancillary studies
15829675|NCT04207190|Drug|Talazoparib|Given PO
15829676|NCT04207190|Drug|Talazoparib Tosylate|Given PO
15829677|NCT04207177|Drug|Mycophenolate Mofetil 500 mg Tab|Twice daily dosing of MMF only for a week before transplantation in this subgroup. All patients will get maintenance treatment With MMF in combination With tacrolimus and steroids after transplantation.
15829678|NCT04207177|Drug|Tacrolimus capsule|Twice daily dosing of tacrolimus only for a week before transplantation in this subgroup. All patients will get maintenance treatment With tacrolimus in combination With MMF and steroids after transplantation.
15829723|NCT04206761|Drug|QVM149|QVM149 is an investigational drug consisting of 150μg indacaterol acetate, 50μg glycopyrronium bromide and 160μg mometasone furoate. The drug is delivered as powder in hard capsules via Breezhaler, a breath-activated device which will deliver a specific dose of medication
15829724|NCT04206761|Drug|High Dose Dual Therapy (ICS/LABA)|High dose inhaled corticosteroid (ICS)/long-acting beta2-agonist (LABA) in any approved drug formulation and delivery device.
15829853|NCT04205838|Drug|Fludarabine|Given via infusion
15829854|NCT04205838|Drug|Fludarabine Phosphate|Given via infusion
15829679|NCT04207151|Behavioral|SNAPS intervention|"The intervention is multi-level yet, targets the weakest chains in the link of PrEP initiation at safety-net hospitals designed for scalability, sustainability, and implementability across a wide range of settings. It consists of Surveillance by STI testing, Navigation by unannounced patient navigators to the Sexual Health Clinic (SHC), Accelerated follow-up with providers with PrEP expertise, Point-of-care PrEP counseling and laboratory testing, and Seamless, consistent, longitudinal, comprehensive care (SNAPS). SNAPS will selectively target those care settings where PrEP prescribing is particularly rare or absent (eg, OB/GYN). Study team will utilize a quasi- experimental design to compare rates of PrEP uptake overall, PrEP initiation in disproportionately-impacted groups, and PrEP retention pre-versus post-initiation of SNAPS, controlling for secular trends."
15829680|NCT04207125|Behavioral|Multilevel psychotherapeutic intervention programme|"Part 1: Educational Training and Mentoring After transferring the patient from the intensive care unit to the transplant surgery unit, nurses are planning a nursing diagnosis called therapy recommendations and coping strategies, effective implementation. 3 days after the transfer, nurses start to give information twice a day (morning and evening) about the medication, which the patients are currently taking. The nurse is also handing out a folder, which contains information about the multilevel intervention programme.
~Individual Treatment Approach Patients, who seem to be non-adherent during their outpatient follow-ups, are contacted through the co-investigators for a one-to-one session. The content of this session is to promote patients engagement in self-management of their chronic illness. The goal of the treatment is to improve the individual's ability to manage symptoms, treatments, physical and psychosocial consequences and lifestyle changes."
15829681|NCT04207112|Drug|Bedaquiline|Bedaquiline is a diarylquinoline class antimicrobial which blocks the proton pump for ATP synthase of mycobacteria. This in turn blocks the ATP production required for cellular energy production and leading to cell death.
15829682|NCT04207112|Drug|Pretomanid|Pretomanid is an nitroimidazole class antimicrobial which interferes with cell wall biosynthesis in mycobacteria. It may have other mechanisms of action as well in non-replicating mycobacteria.
15829683|NCT04207112|Drug|Moxifloxacin|Moxifloxacin is an 8-methoxyquinolone class antimicrobial that is a potent inhibitor of DNA gyrase and topoisomerase IV in bacteria
15829684|NCT04207112|Drug|Linezolid|Linezolid, an oxazolidinone class antimicrobial which works by inhibiting ribosomal protein synthesis. It is approved for Gram-positive bacterial infections, and is increasingly being used for drug resistant TB disease.
15829685|NCT04207112|Drug|Clofazimine|Clofazimine (Cfz) is a lipophilic riminophenazine licensed for treatment of leprosy. Its mechanism(s) of action remains unclear, but existing evidence suggests production of reactive oxygen species within Mycobacterium tuberculosis is one mechanism.
15829686|NCT04207112|Drug|Standard Drugs|Locally accepted standard of care which is consistent with the WHO recommendations for the treatment of M/XDR-TB.
15829687|NCT04207099|Device|MolecuLight i:X Imaging Device|The MolecuLight i:X Imaging Device uses built-in light-emitting diodes (LEDs) emitting 405 nm violet excitation light to illuminate the wound during fluorescence imaging in (FL-Mode). The light excites biological components of the wound and surrounding tissues. Non-biological components may also fluoresce although their presence in wounds is less common, provided the wound has been cleaned following standard care protocols. The resulting wound fluorescence wavelengths emitted are typically between 420 - 700 nm in the visible wavelength spectrum. In FL-mode, a customized fluorescence emission filter, which is mechanically placed in front of the built in imaging sensor and allows real-time capture of wound, limits the visualization of fluorescence to wavelengths between 500-545 nm, which typically appears green in color, and 600-665 nm, which typically appears red in color.
15829688|NCT04207086|Drug|Pembrolizumab|Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
15829689|NCT04207086|Drug|Lenvatinib|Lenvatinib is an oral potent multiple RTK inhibitor that selectively inhibits VEGF receptors, VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4), fibroblast growth factor receptor (FGFR1-4), platelet derived growth factor (PDGFRα), stem cell factor receptor (KIT), and rearranged during transfection (RET).
15829690|NCT04207073|Device|Mobilization of median nerve|Neural mobilization
15829691|NCT04207060|Drug|Indomethacin|50 mg twice a day by mouth.
15829692|NCT04207060|Drug|Placebos|Lactose capsules not containing active study drug will be taken twice a day.
15829693|NCT04207047|Device|Genius|"The Infini Radiofrequency System (K121481) is the predicate device. It is a minimally invasive radiofrequency device that employs a bipolar microneedle electrode system indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles.
~The Genius system is substantially equivalent to the Infini device with a digitally controlled direct drive mechanism for needle insertion and an improved needle design for easier needle insertion. The active tip of the Genius system is the substantially equivalent to the Infini device. The handpiece of the Genius system has also been redesigned to be lighter and more ergonomic."
15829694|NCT04207047|Device|eC02|The eCO2 Laser System (K091115) is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Additionally, the 120 micron and 300 micron spot sizes are used in the treatment of wrinkles; rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia. The fractional 90 degree BellaV handpiece is intended to provide fractional CO2 treatment of skin and is not yet cleared.
15829695|NCT04207047|Device|PicoPlus|The PICOPLUS Laser System (K173700) is indicated for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery as follows:
15829696|NCT04207047|Device|LaseMD|The LaseMD Laser System (K171009) is a 1927 factional thulium laser indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephiledes (freckles). The cleared LaseMD system is a 5W system.
15829725|NCT04206748|Device|iGlucose Smart Meter System|Subjects will have routine care enhanced by use of theThe iGlucose Smart meter system. This is an example of integration of a SMBG system with internet-based technology; including cell phone notifications for reminders, feedback, and communication with clinicians
15829726|NCT04206748|Device|Routine Care-RX meter|Subjects will receive routine care with the insurance prescribed glucose meter. They will self manage with traditional diabetes diary.
15829698|NCT04207034|Procedure|flap surgery with diode laser|"Patient will be asked to rinse with 0.2% chlorhexidine mouthwash. Following the administration of local anaesthesia 2% lignocaine hydrochloride ( with 1: 80,000 epinephrine) , Laser application will be carried out , with the help of 810 nm (A.R.C LASER FoxTM) diode laser with a flexible optic tip of 300µm . The sulci will be lased with a repeated beam ( 0.2 sec on 0.3 sec off) at an output power of 1.0 W.
~Intracrevicular incision will be placed with the help of 15c Bard Parker surgical blade , full thickness mucoperiosteal flap will be elevated .
~Debridement of granulation tissue will be done and flap will be suture back in position using 3-0 black breaded silk suture, the site will be covered with non eugenol periodontal dressing for protection.
~Postoperative instructions will be given to the patient. 2 ml blood will be collected at baseline(sample 1) , at 5 minutes (sample 2) and within 20-30 minutes (sample 3) of starting the procedure."
15829699|NCT04207034|Procedure|flap surgery|"Patient will be asked to rinse with 0.2% chlorhexidine mouthwash. Following the administration of local anaesthesia 2% lignocaine hydrochloride ( with 1:80,000 epinephrine) ,intracrevicular incision will be placed with the help of 15c Bard Parker surgical blade , full thickness mucoperiosteal flap will be elevated .
~Debridement of granulation tissue will be done and flap will be suture back in position using 3-0 black breaded silk suture, the site will be covered with non eugenol periodontal dressing for protection.
~Postoperative instructions will be given to the patient. 2 ml blood will be collected at baseline(sample 1) , at 5 minutes (sample 2) and within 20-30 minutes (sample 3) of starting the procedure"
15829700|NCT04207021|Dietary Supplement|Experimental: Curcumin derivate|two capsules per day, one capsule to be taken before breakfast and one before dinner for a period of 6 weeks.
15829701|NCT04207021|Dietary Supplement|Placebo|two capsules per day (containing no bioactive compound, only hydroxypropyl methylcellulose, gellan gum, pigment), one capsule to be taken before breakfast and one before dinner for a period of 6 weeks.
15829702|NCT04207008|Other|iBDecide Decision Support Application|The iBDecide app provides an electronic tools to learn more about UC, track symptoms, create a nutrition diary, enter reminders for medication and clinic visits, as well as learn more about treatment options and compare UC medications.
15829703|NCT04206995|Other|Solid Phase Microextraction (SPME)|A SPME fibre is held directly above skin cancer, or healthy skin for a period of less than 30 minutes to capture VOCs. No drug will be used. This is to investigate the capability of the technique in capturing VOCs.
15829704|NCT04206995|Other|Absorptive patch|An adsorptive patch, covering skin cancer and healthy skin sites will be applied for a period of maximum 30 minutes to capture VOCs. No drug will be used. This is to investigate the capability of the technique in capturing VOCs.
15829705|NCT04206982|Procedure|Destruction of Marshall bundles|Destruction of Marshall bundles by ethanol 96% infusion (2 separate injections of 5ml on 1 minute each) followed by ablation of the distal coronary sinus bundles, the ridge and the saddle.
15829706|NCT04206982|Procedure|Pulmonary veins isolation|Achievement of a wide disconnection of the right and left pulmonary veins.
15829707|NCT04206982|Procedure|Linear ablation in the left and right atria|Ablation of the mitral, the roof, and the cavo-tricuspid isthmus.
15829708|NCT04206969|Behavioral|Transcultural psychotherapy|In addition to usual care, the participants receive transcultural psychotherapy
15829709|NCT04206943|Biological|Car-T Cell Therapy|"Lymphodepletion Protocol:
~-6. Day: Cyclophosphamide 300 mg / m^2 i.v.
~-5. -4. and -3. Days: Fludarabine 30 mg / m^2 i.v. In addition, one day before the lymphodepletion protocol, xanthine oxidase enzyme inhibitor tablets received 100 mg / day p.o. and 0.9% sodium chloride solution 2000 ml / day i.v. infusion on protocol day received and continues for 2 weeks
~Car-T cells are administered in 3 split doses. Day 0: 20% or 40% (20% in patients with high tumor burden - in patients with bulky disease and / or more than 15% blast in bone marrow, 40% in patients with low tumor burden) Day 2: 30% or 50%, (the total amount of Car-T cell dose that should be given in the first 2 days should be 70%.) Third dose (%30);is given on the 7th day in the absence of cytokine release syndrome, or if cytokine release syndrome occurs, Car-T cells are given within 1 month if the number of copies falls below 5,000 / ml in 2 consecutive measurements."
15829710|NCT04206930|Other|Art Therapy|1 session of 2 hours per week in a closed group for 10 weeks
15829711|NCT04206917|Device|Multi Pulse Therapy|The Cardialen External Stimulation System (CESS) is the research delivery system for the proprietary Cardialen MultiPulse Therapy (MPT). The CESS is a custom designed and built research device. It is comprised of off-the-shelf commercial components (power supplies, waveform generators, laptop computer, monitor, rack, ECG system, leads, etc.) combined with a custom electrical circuit board and custom software.
15829712|NCT04206878|Diagnostic Test|Point-of-care birth test|Collect quantitative data through clinical chart and form abstractions; collect qualitative data through in-depth interviews with caregivers, health workers and policymakers
15829713|NCT04206865|Drug|Sacubitril-Valsartan|Patient's will be randomized to ICU initiation of sacubitril-valsartan vs. alternate oral vasodilator therapy in 1:1 fashion
15829714|NCT04206865|Drug|Standard Oral Vasodilators|Patient's will be randomized to ICU initiation of sacubitril-valsartan vs. alternate oral vasodilator therapy in 1:1 fashion. Alternate vasodilators will include ARBs, hydralazine and isosorbide dinitrate, and ACEi
15829715|NCT04206852|Procedure|Balloon pulmonary angioplasty|Balloon pulmonary angioplasty is an interventional technique where a balloon catheter is used to recanalize affected segments of pulmonary arteries identified during angiography.
15829716|NCT04206826|Device|PREDELFI|It's a natural film which contains a concentrated alpha-GOS (alpha-galacto-oligosaccharide) soy extract, a milk protein concentrate containing caseins and whey proteins and vegetable glycerin
15829717|NCT04206826|Device|CONTROL|It's a natural film which is devoided of active ingredient. It contains sodium alginate; vegetable glycerin, caramel, beta carotene and water.
15829718|NCT04206813|Drug|Gardasil 9 2 dose regimen|a 2-dose regimen of Gardasil 9 at 0 and 6 months
15829719|NCT04206813|Drug|Gardasil 9 3 dose regimen|standard 3-dose regimen of Gardasil 9 at 0, 2, 6 months
15829720|NCT04206813|Drug|Gardasil 9 rescue dose|A rescue dose of Gardasil 9 will be given at 12 months
15829721|NCT04206800|Diagnostic Test|Ejaculatory abstinence less than 24 hours|Males will have ejaculatory abstinence less than 24 hours before providing a semen sample the day of egg retrieval
15829722|NCT04206787|Drug|Afatinib|drug
15829768|NCT04206410|Dietary Supplement|Maltodextrin|Maltodextrin as placebo
15829769|NCT04206397|Behavioral|affective touch|Various types of touch such as brushing, pressure, and tapping, as well as heat pain
15829727|NCT04206735|Other|Interprofessional Education (IPE)|We will use the training stated in the arm description above. In addition, prerecorded webinars that include evidence-based practice management of COPD will be released every month for the champions and clinicians to watch at their leisure.
15829728|NCT04206735|Other|Usual care|Usual care of patients hospitalized with severe COPD exacerbation
15829729|NCT04206722|Device|Shock Wave Therapy|Shock Wave therapy - hip osteoarthritis program
15829730|NCT04206722|Device|Ultrasound|Ultrasound 0.7W/cm2
15829731|NCT04206709|Procedure|aerobic effort|Active upper limbs pedaling while maintaining a pulse calculated to be approximately 60% of the predicted maximum heart rate of each patient for 20 minutes.
15829732|NCT04206709|Other|passive pedaling|20 minutes passive pedaling by upper limbs.
15829733|NCT04206670|Device|In-Home Technology System and Questionnaires|Participants self-install the in-home technology system in their homes after enrollment in the study (i.e., consent procedures and initial questionnaire). Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using caregiver resources and a trusted circle of friends and family who are encouraged to stay in contact with the caregiver and person with dementia or mild cognitive impairment.
15829734|NCT04206670|Device|Waiting Control In-Home Technology System and Questionnaires|Participants self-install the in-home technology system in their homes six months after their enrollment in the study (i.e., consent procedures and initial questionnaire). Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using caregiver resources and a trusted circle of friends and family who are encouraged to stay in contact with the caregiver and person with dementia or mild cognitive impairment.
15829735|NCT04206657|Drug|1mg KHK7580|Single oral dose administration of 1mg KHK7580
15829736|NCT04206657|Drug|3mg KHK7580|Single oral dose administration of 3mg KHK7580
15829737|NCT04206657|Drug|6mg KHK7580|Single oral dose administration of 6mg KHK7580
15829738|NCT04206657|Drug|12mg KHK7580|Single oral dose administration of 12mg KHK7580
15829739|NCT04206657|Drug|6mg KHK7580 for 8days|multiple oral dose administration of 6mg KHK7580 for 8days
15829740|NCT04206644|Other|biological analysis|biological analysis of the Concentration of CCL18
15829741|NCT04206631|Drug|Doxycycline Capsule|Doxycycline capsule 100 mg/day, tretinoin cream 0.05% on face every night, benzoyl peroxide gel 2.5% on face in the morning and afternoon.
15829742|NCT04206631|Procedure|Comedone extraction|Comedone extraction, tretinoin cream 0.05% on face every night, benzoyl peroxide gel 2.5% on face in the morning and afternoon.
15829743|NCT04206618|Drug|Teriparatide|1 subcutaneous injection daily for 12 months
15829744|NCT04206618|Drug|Denosumab|1 subcutaneous injection every 6 months for 12 months
15829745|NCT04206605|Drug|Lanadelumab|Participants will receive 300 mg of lanadelumab solution in a PFS SC injection once q2w for 26 weeks.
15829746|NCT04206605|Other|Placebo|Participants will receive placebo matched to lanadelumab SC injection once q2w for 26 weeks.
15829747|NCT04206592|Device|Oropharyngeal leak pressure during pneumoperitoneum.|Oropharyngeal Leak Pressure (OLP) will be measured by closing the expiratory valve of the circle system at a fixed gas flow of 3 litres/min (maximum allowed 40 cmH2O) recording the pressure at which equilibrium has been reached or audible air is leaking.
15829748|NCT04206579|Drug|10% Dextrose|A mixture of 150 cc dextrose 10% in oral formulation
15829749|NCT04206579|Drug|Natrium Dextrose|A mixture of 150 cc dextrose 10% + 20 cc sodium in oral formulation
15829753|NCT04206540|Other|ABVN stimulation|Stimulate the Auricular Branch of the Vagus Nerve in the ear
15829754|NCT04206540|Other|Vagal Maneuvers|Stimulate the Vagus Nerve by using different techniques like drinking water, drinking ensure, cold stimulus, carotid massage, valsalva maneuver and others
15829755|NCT04206527|Behavioral|Training of AHSAs on PCC for FP|ASHAs provided with training on FP methods and counseling plus PCC for FP
15829756|NCT04206527|Behavioral|Enhanced FP training|Participation in an enhanced FP training including PCC
15829757|NCT04206514|Behavioral|Person Centered Care - Post Abortion Support|Post abortion phone based support
15829758|NCT04206501|Device|Medtronic ICD with Opti Vol-Monitor|Physiologic and functional data from Cardiac Implantable Electronic Devices (CIEDs), including information on heart rate, activity, and fluid status derived from the OptiVol monitor, together with a concurrent patient engagement strategy through remote interactions, can be used to optimize the medical management of HF patients implanted with an ICD.
15829759|NCT04206488|Drug|JNJ-70033093|Participants will receive JNJ-70033093 orally.
15829760|NCT04206488|Drug|Digoxin|Participants will receive digoxin orally.
15829761|NCT04206475|Other|rehabilitation|"the rehabilitation program consisted of an intensive treatment lasting 4 weeks, and including 3 daily interventions each working day (5 working days per week, for a total of 20 days of treatment and 60 sessions). The 3 daily sessions were organized as follows:
~1 physio-kinesis and/or occupational therapy, 1 speech therapy, and 1 neuro-psychology treatment.
~Each session lasted 45 minutes."
15829762|NCT04206475|Other|Intensive Memory-Focused Training Program (IM-FTP)|During each session, the patient was engaged in a one-to-one interaction with the therapist. Overall, the treatment targeted the following memory subfunctions: verbal and visuo-spatial short-term memory, verbal and visuo-spatial long-term memory, working memory and procedural memory
15829763|NCT04206462|Other|Questionnaire of eating habits|frequency and type of aliments
15829764|NCT04206449|Other|Therapeutic decision PSG|Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)
15829765|NCT04206449|Other|Therapeutic decision Infrared thermgraphy system|Also randomizing for Infrared thermography system
15829766|NCT04206436|Drug|Cftr Modulators|CFTR modulators are drugs used to treat cystic fibrosis
15829767|NCT04206410|Dietary Supplement|Probiotic|Multispecies probiotic mixture administered to patients according to the randomization list
15829772|NCT04206358|Biological|OrienX010 combination with JS001|"OrienX010 Produced by Oriengene Biotechnology Co., Ltd. Strength: 1.0 mL/vial. Label claim: Titer 8.0 × 10^7Pfu/mL, NMT 1 × 10 particles11VP/mL.
~JS001 Produced by Junshi Biosciences Co., Ltd. Strength: 240 mg/6 mL/vial; Sterile water injection dosage form; Expiry date: 24 months; Date of manufacture: Based on the date of manufacture indicated in the product package."
15829773|NCT04206345|Other|exercise with blood flow restriction|Elbow bending exercises with blood flow restriction will be performed to the exercise group.
15829774|NCT04206345|Other|exercise|Elbow bending exercises
15829779|NCT04206293|Device|Juvederm® VOLITE|1 mL of Juvéderm® VOLITE contains hyaluronic acid gel 12.0 milligram (mg), lidocaine hydrochloride 3.0 mg in a phosphate buffer pH 7.2 q.s. 1 mL (or gram).
15829780|NCT04206280|Behavioral|Use of a pedometer following surgery|Subjects in the study group will receive a pedometer with graduated step count goals as discussed in arm description.
15829781|NCT04206280|Behavioral|Standard of care|Subjects in the control group will be counseled on the importance of ambulation during their pre-operative visit.
15829782|NCT04206267|Device|Acceledent|Device for accelerating tooth movement
15829783|NCT04206254|Biological|gp96|heat shock protein gp96-peptide complex made from a person's tumor cells may help the body build an effective immune response to kill tumor cells.
15829784|NCT04206241|Diagnostic Test|Point of care early infant diagnosis (POC EID)|HIV testing where the blood sample is processed at either the facility itself or a nearby site that is closer to the facility than a laboratory. With POC EID, blood samples do not have to travel to the laboratory for processing.
15829785|NCT04206228|Drug|Intravenous iron isomaltoside|"The active drug, iron isomaltoside, will be administered as a single, intravenous infusion of 20 mg/kg body weight (rounded off to the nearest 100 mg) dissolved in 100 ml NaCl as recommended by the drug manufacturer (on-label treatment), over 30 minutes only (1,67 ml/min)."
15829786|NCT04206228|Drug|Placebo|The placebo will be prepared according to the randomisation code, and administered as a single intravenous infusion over 30 minutes only (1,67 ml/min).
15829787|NCT04206202|Device|3D-Printed Patient-Specific Intramedullary Guide|The 3D-printed patient-specific intramedullary guide is used in TKA to control femoral component rotation.
15829788|NCT04206189|Dietary Supplement|carbohydrate group - carbohydrate (400ml)|Randomly selected patients of the carbohydrate group are given oral carbohydrate (400ml) 2-3 hours before surgery. In contrast, patients in the control group are fasted water 2 hours before surgery according to the standard protocol.
15829789|NCT04206176|Drug|Ticagrelor|Ticagrelor 45mg twice daily per oral administration
15829790|NCT04206163|Diagnostic Test|68Ga-DOTA-TOC PET/CT|Somatostatin receptor imaging
15829791|NCT04206163|Biological|Blood sample|Analysis of inflammatory biomarkers
15829792|NCT04206150|Procedure|the three different sites of continous adductor canal block: the adductor canal catheter is inserted at femoral triangle apex|In group 1, the adductor canal catheter is inserted at femoral triangle apex (the proximal end of the adductor canal).
15829793|NCT04206150|Procedure|the three different sites of continous adductor canal block: the adductor canal catheter is inserted femur length/15*2 cm above the location|In group 2, the adductor canal catheter is inserted femur length/15*2 cm above the location where the nerve block performed in group 1.
15829794|NCT04206150|Procedure|the three different sites of continous adductor canal block: the adductor canal catheter is inserted femur length/15 cm below the location|In group 3, the adductor canal catheter is inserted femur length/15 cm below the location where the nerve block performed in group 1.
15829795|NCT04206137|Other|Group A (PNF rhythmic initiation group )|Lifting of arms and push the head back through the pattern of flexion -abduction-external rotation and neck in extension to the left in opposition of therapist hand resistance will be asked to do. At the end range of motion extensor muscles of back will start to contract.Then, reversing of that movement pattern to extension-adduction-internal rotation and neck flexion to right against the therapist resisting hands will be asked. this will be repeated on both sides
15829796|NCT04206137|Other|Group B (Swiss ball exercises)|"Supine position: A ball will be placed under patient neck, and will be asked to bend hip and knee up to 90°. 5 times, 10 seconds hold Supine position: With a ball below the pelvis, knees bent, the ball press will be done with pelvis. 5 times, for 10 seconds hold.
~Crawling position: With a ball below one knee while keeping toes away from contact with the floor, the patient will balance first to stabilize the posture and slowly raise the other lower limb. This exercise will be performed in turn for the two lower limbs 10 times, with 10 seconds hold.
~Prone position: the patient will place a ball in front of pelvis and will repeatedly raise and lowered the two lower limbs alternately. There will be 10 repetitions, with 5 sets, taking 15 seconds rest between each set."
15829797|NCT04206124|Procedure|Brown Fat Harvest During Anterior Neck Surgery|During previously indicated thyroid gland removal or anterior cervical spine surgery, as scheduled at UNMHSC, the surgeon will identify the large muscle on the side of the neck in the surgical field. Using minimal dissection adjacent to the muscle, they will then remove 5-10mg of brown fat from this region. These samples will be further analyzed using various biochemical tools.
15829798|NCT04206111|Procedure|Preoxygenation|preoxygenation with high flow nasal cannula at 40l/min for 5min
15829799|NCT04206098|Other|Factors associated with Hospital admission for an Acute Exacerbation Chronic Obstructive Pulmonary Disease (AECOPD)|Develop a descriptive predictive model fo factors that influence clinical characteristic of patients that require hospital admission
15829800|NCT04206085|Device|Viveve - Active|Radiofrequency and Cryogen-Cooling
15829801|NCT04206085|Device|Viveve - Cryogen-Alone|Cryogen-Cooling
15829802|NCT04206085|Device|Viveve - Sham|Sham
15830039|NCT04204291|Procedure|Bronchoscopy|Multiple level sampling of the respiratory mucosa (cytology brush and biopsies forceps)
15829803|NCT04206072|Drug|D-0316 Capsule|"The initial dose of D-0316 is 75 mg orally once daily (QD) for one cycle, and then increased to 100 mg orally QD in the absence of CTCAE grade ≥ 2 headache or thrombocytopenia during the first cycle, otherwise maintained to 75 mg orally QD until disease progression or meet the discontinuation criteria. A cycle of treatment is defined as 21 days of once daily treatment.
~Following objective disease progression according to RECIST 1.1, as per investigator assessment, patients who were confirmed T790M mutation positive may have the option to continuously receive D-0316."
15829804|NCT04206072|Drug|Icotinib Hydrochloride Tablets|"Icotinib (125 mg three times daily, orally), treatment should continue until disease progression or meet the withdrawal criteria. A cycle of treatment is defined as 21 days of three times daily treatment.
~Following objective disease progression according to RECIST 1.1, as per investigator assessment, patients who were randomized to Icotinib arm and confirmed T790M mutation positive have the option to receive D-0316 (crossover to active D-0316)."
15829805|NCT04206059|Radiation|MRI|A non-contrast brain MRI will be acquired for localizing EEG slow waves
15829806|NCT04206059|Diagnostic Test|Quantitative Sensory Testing (QST)|Quantitative sensory testing (QST) using increasing ramp thermal stimulation (32-52 ºC) will be delivered to compare arousal thresholds between conditions.
15829807|NCT04206059|Diagnostic Test|Home sleep study|Unattended home sleep studies will be conducted on the night preceding sedation and on the night following sedation to assess changes in slow wave homeostasis.
15829808|NCT04206059|Other|Acoustic stimulation (65db) up-slope of EEG with QST|Acoustic stimulation (65 db) synchronized in-phase with the up-slope of EEG slow waves
15829809|NCT04206059|Other|Acoustic stimulation (65db) down-slope of EEG with QST|65 dB acoustic stimulation synchronized with the down-slope of the EEG slow waves (anti-phase)
15829810|NCT04206059|Other|0 db with QST|sham stimulation (0 dB volume)
15829811|NCT04206059|Drug|Dexmedetomidine|All participants will receive dexmedetomidine with sedation titrated step-wise to 2, 3 or 4 ng/ml
15829812|NCT04206046|Procedure|Spinal anaesthesia|Patients will receive a spinal anaesthetic
15829813|NCT04206046|Procedure|General anaesthesia|patients will receive a general anaesthetic and a femoral nerve block
15829814|NCT04206033|Other|Observational study|Observational study
15829815|NCT04206020|Drug|SkQ1 Vehicle Solution|SkQ1 Ophthalmic Solution Vehicle
15829816|NCT04206020|Drug|SkQ1 Ophthalmic Solution|SkQ1 Ophthalmic Solution
15829817|NCT04206007|Biological|UMC119-06|Cohort 1: Low does of UMC119-06 Cohort 2: Medium does of UMC119- 06 Cohort 3: High does of UMC119-06
15829818|NCT04205994|Drug|Tolcapone 200 MG|Tolcapone is a brain penetrant catechol-O-methyltransferase (COMT) inhibitor. It will be administered in randomized, double-blind, counterbalanced fashion with a placebo.
15829819|NCT04205994|Other|Functional Magnetic Resonance Imaging (fMRI)|FMRI provides an indirect and noninvasive measure of brain activity.
15829820|NCT04205981|Other|Aerobic exercise|8-week aerobic exercise (moderate intensity), 5 times per week, 60 min per session. Exercise training under supervision of trained staff.
15829821|NCT04205968|Drug|Fluorouracil|Given IV bolus or IV
15829822|NCT04205968|Drug|Irinotecan|Given IV
15829823|NCT04205968|Drug|Irinotecan Hydrochloride|Given IV
15829824|NCT04205968|Drug|Leucovorin|Given IV
15829825|NCT04205968|Drug|Leucovorin Calcium|Given IV
15829826|NCT04205968|Drug|Paclitaxel|Given IV
15829827|NCT04205968|Biological|Ramucirumab|Given IV
15829828|NCT04205955|Other|Best Practice|Receive healthy living education via phone call
15829829|NCT04205955|Dietary Supplement|Dietary Intervention|Receive diet modification coaching via phone call
15829830|NCT04205955|Other|Message|Receive motivational messages via email and/or text message
15829831|NCT04205955|Other|Quality-of-Life Assessment|Ancillary studies
15829832|NCT04205955|Other|Questionnaire Administration|Ancillary studies
15829833|NCT04205942|Device|Argon Plasma Jet|Cold Plasma (CP) therapy is applied in the first week of treatment on a daily schedule, in the second week CP is applied every second day. In total, 8 applications are performed with a one day schedule variance.
15829834|NCT04205942|Device|Placebo|Sham Cold Plasma (sham-CP) (switched off Electric field, no plasma production, just gas) therapy is applied in the first week of treatment on a daily schedule, in the second week sham-CP is applied every second day. In total, 8 applications are performed with a one day schedule variance.
15829835|NCT04205929|Drug|Placebo|Placebo (oral) once daily for 30 days. Treatment to be started after 3 consecutive days of bleeding
15829836|NCT04205929|Drug|Curcumin|Curcumin 600 mg (oral) once daily for 30 days. Treatment to be started after 3 consecutive days of bleeding
15829837|NCT04205916|Drug|Dexamethasone|Drugs to be administer during cataract surgery to experimental group
15829838|NCT04205916|Other|Standard of care surgery|Standard method used for surgery and the use of post operative drops
15829839|NCT04205903|Drug|Nilotinib|Given PO
15829840|NCT04205903|Drug|Nilotinib Hydrochloride Monohydrate|Given PO on cycle 1 Days 7, 14, 15 once a day 24 hours prior to the paclitaxel infusion and again 30 minutes prior to the paclitaxel infusion on days 8, 15.
15829841|NCT04205903|Drug|Paclitaxel|Given IV weekly on days 1, 8, 15, of every 21 days, at a starting dose of 80mg/m2
15829842|NCT04205903|Other|Placebo|Given PO
15829843|NCT04205903|Other|Questionnaire Administration|Ancillary studies
15829844|NCT04205890|Drug|Ketamine|The ketamine will be injected per the doctor's orders to achieve a dissociative state; dosage varies between 75mg - 1000mg depending on every individual's unique treatment plan.
15829845|NCT04205877|Device|Transcatheter PDA Closure|Device utilized for closure of PDA, study is to help assure continued safety and effectiveness of FDA approved Amplatzer Piccolo Occluder device as well as other devices used off label for PDA closure in premature infants less than 2 kg at the time of device implant.
15829846|NCT04205864|Drug|Thrombi-Gel|Thrombin gel Matrix applied on pelvic lymphadenectomy areas after lympadenectomy
15829847|NCT04205864|Procedure|Conventional Pelvic lymphadenectomy|Conventional Pelvic lymphadenectomy
15829848|NCT04205851|Drug|KIN-1901|KIN-1901 is a fully human monoclonal antibody (mAb).
15829849|NCT04205851|Drug|Placebo|Saline
15829850|NCT04205838|Biological|Anakinra|Given SC
15829851|NCT04205838|Biological|Axicabtagene Ciloleucel|Given via infusion
15829855|NCT04205825|Other|The New Safety Checklist|Patients randomized in the New Safety Checklist intervention, nurses will use the New Safety Checklist, which we have named: INCARDIO-PASS (Interventional CARDIOlogy-Patient Safety System) checklist.
15829856|NCT04205812|Drug|Retifanlimab|INCMGA00012 administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.
15829857|NCT04205812|Drug|Placebo|Placebo administered intravenously every 3 weeks on Day 1 of each cycle for up to 35 cycles.
15829858|NCT04205812|Drug|Pemetrexed|Pemetrexed administered intravenously every 3 weeks on Day 1 of each cycle.
15829859|NCT04205812|Drug|Cisplatin|Cisplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.
15829860|NCT04205812|Drug|Carboplatin|Carboplatin administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.
15829861|NCT04205812|Drug|Paclitaxel|Paclitaxel administered intravenously every 3 weeks on Day 1 of each cycle for 4 cycles.
15829862|NCT04205812|Drug|nab-Paclitaxel|nab-Paclitaxel administered intravenously every 3 weeks on Days 1, 8, and 15 of each cycle for 4 cycles.
15829863|NCT04205799|Drug|Cabozantinib|Cabozantinib will be administered at the daily dose of 60 mg given orally in a 4-week cycle. It will be continued without interruption until disease progression or discontinuation for any cause.
15829864|NCT04205786|Dietary Supplement|Vitamin B12|Vitamin B12, orally, 2500 mcg, daily, for 90 days
15829865|NCT04205786|Other|Blood collection|"Blood collection for laboratory testing will occur within 10 days of signing the consent form, on day 45 +/- 10 days, and on day 90 +/- 10 days. It will include:
~Serum B12 levels
~CRP
~Homocysteine level
~MMA"
15829866|NCT04205786|Other|Brief Pain Inventory - Short Form survey|Brief Pain Inventory - Short Form survey
15829867|NCT04205786|Other|FACT-ES Trial Outcome Index (Version 4)|FACT-ES Trial Outcome Index (Version 4)
15829868|NCT04205786|Other|Questionnaire to Assess Adherence to Aromatase Inhibitors|Questionnaire to Assess Adherence to Aromatase Inhibitors
15829869|NCT04205786|Other|Demographics Questionnaire|Demographics Questionnaire
15829870|NCT04205773|Device|CompuFlo|After priming with 5 mL saline, the catheter was connected to CompuFlo to record the occurrence of pulsatile waveforms and/or their disappearance during its removal
15829871|NCT04205760|Combination Product|Nutrition + exercise|Patients will receive preoperative optimization consisting of oral nutrition support (Fresubin 3.2 kcal) and bed-cycling (50 minutes per day) for 5-14 days before surgery.
15829872|NCT04205734|Diagnostic Test|MTX Assessment|Measurement of Methotrexate Polyglutamate levels.
15829873|NCT04205721|Behavioral|School-based sexuality and HIV prevention scripted lesson plans|The revised life orientation content and implementation approach were designed to address gaps in prior implementation of the sexuality and HIV education content. By using scripted lesson plans and training teachers to use these, it was thought that students would get better information and lessons on the material important for HIV prevention.
15829874|NCT04205708|Diagnostic Test|Tuberculosis test|Tuberculosis (TB) test: A blood sample is collected for lab testing to determine if you have tuberculosis (QuantiFeron test). Alternatively, the test is done by injecting a small amount of fluid (called tuberculin) into the skin on the lower part of the arm. A person given the tuberculin skin test must return within 48 to 72 hours to have a trained health care worker look for a reaction on the arm.
15829875|NCT04205708|Diagnostic Test|Chest X-ray|Chest X ray: non-invasive medical test that helps physicians diagnose and treat medical conditions of the lungs and chest. The Chest X-ray will be done to check for abnormalities on the lungs. The test is non-invasive.
15829876|NCT04205708|Diagnostic Test|Pulmonary Function Test|A pulmonary function test (PFT, spirometry) is a breathing test that measures how much air your lungs can hold as well as how hard and fast you can blow air out of your lungs. The test is not invasive and involves blowing into a machine.
15829877|NCT04205695|Procedure|CEMP (closed-ended multiport catheter) group|The linear probe will be placed parasagittally at the junction between the clavicle and the choroidal process. After medial to lateral scanning, the branches of the brachial plexus will be seen as posterior, lateral and medial truncus around the axillary artery. Contiplex® FX Non-Stimulating Tuohy Set, 17Ga. x 3½ inches. the Non-Stimulating Needle and the closed-tip multiport catheter will be delivered through the needle and placed at the 6 o'clock position relative to the axillary artery and then secured by forming a tunnel under the skin. After negative aspiration, the location of the catheter will be confirmed by injecting 1-2 ml of local anesthetic under ultrasonic guidance.
15829878|NCT04205695|Procedure|OESP (open-ended single port catheter) group|The linear probe will be placed parasagittally at the junction between the clavicle and the choroidal process. After medial to lateral scanning, the branches of the brachial plexus will be seen as posterior, lateral and medial truncus around the axillary artery. Contiplex® Non-Stimulating Tuohy Set, 17Ga. x 3½ inches. hhe Non-Stimulating Needle and the Non-Stimulating open-ended catheter will be delivered through the needle and placed at the 6 o'clock position relative to the axillary artery and then secured by forming a tunnel under the skin. After negative aspiration, the location of the catheter will be confirmed by injecting 1-2 ml of local anesthetic under ultrasonic guidance.
15829879|NCT04205695|Procedure|Patient-controlled analgesia|A patient-controlled analgesic device will be attached to the catheter for postoperative analgesia. continuous peripheral nerve patient-controlled analgesia is as follows: 0.125% bupivacaine; hourly infusion: 4 ml / hour, pca dose (bolus): 5 ml / hour, lock-up time: 30 min, 4-hours limit: 30 ml.
15829880|NCT04205682|Drug|Cannabidiol|CBD capsules administered BD for 4-days (800-1200 mg/day), placebo day 5
15829881|NCT04205682|Drug|Placebo|Placebo capsules administered BD for 5 days
15829882|NCT04205669|Drug|Benzyl Benzoate 25% Topical Application Lotion|Applied to skin for the treatment of scabies
15829883|NCT04205656|Biological|Leukocyte-Poor Platelet Rich Plasma (LP-PRP)|Participants will have a knee injected with Platelet-Rich Plasma (PRP) obtained from a venous whole blood draw from the vein.
15829884|NCT04205656|Biological|Bone Marrow Concentrate (BMC)|Participants will have a knee injected with BMC stem cells harvested from the iliac crest
15829885|NCT04205656|Other|Control group (Placebo)|Participants will undergo ACLR surgery with no injection into their knee.
15829886|NCT04205643|Biological|CT-P13 SC (Infliximab)|Subcutaneous injection of CT-P13 SC
15829887|NCT04205643|Other|Placebo SC|Subcutaneous injection of Placebo SC
15829888|NCT04205630|Drug|SYD985|SYD985 powder for concentrate for solution for infusion
15829889|NCT04205617|Other|produce prescription and nutrition education|Participants will receive diabetic appropriate groceries, diabetes education classes led by volunteer doctors and nurses, cooking demonstrations, shared meals, 1:1 and group coaching by dietitians.
15829890|NCT04205604|Drug|18F-Fluoro Dopa Imaging|Imaging with 18F-Fluoro Dopa PET Imaging
15829891|NCT04205591|Procedure|split bone block technique|A graft surgery using autogenous bone chips surrounded by a rigid framework made over the atrophic sites of the mandible and maxilla to obtain bone augmentation to support dental implants
15829892|NCT04205578|Drug|dl-3-n-butylphthalide (NBP)|25 mg of NBP in 100 mL of normal saline was administered intravenously since the day of extracranial-to-intracranial bypass surgery and continued twice daily for 14 postoperative days.
15829893|NCT04205578|Drug|Normal Saline 0.9% Infusion Solution|100 mL of normal saline was administered intravenously since the day of extracranial-to-intracranial bypass surgery and continued twice daily for 14 postoperative days.
15829894|NCT04205565|Drug|High dose group: L-oxiracetam Injection|L-oxiracetam injection, 4 vials, once a day, IV. Placebo injection of oxiracetam, 6 vials, once a day, IV.
15829895|NCT04205565|Drug|Low dose group: L-oxiracetam Injection|L-oxiracetam injection, 3 vials, once a day, IV. Placebo injection of l-oxiracetam, 1 vials, once a day, IV. Placebo injection of oxiracetam, 6 vials, once a day, IV.
15829896|NCT04205565|Drug|Control group: Oxiracetam Injection|Placebo injection of l-oxiracetam, 4 vials, once a day, IV. Oxiracetam injection, 6 vials, once a day, IV.
15829897|NCT04205565|Drug|Placebo group: Placebo Injection|Placebo injection of l-oxiracetam, 4 vials, once a day, IV. Placebo injection of oxiracetam, 6 vials, once a day, IV.
15829898|NCT04205552|Drug|Nivolumab 10 MG/ML Intravenous Solution|Neoadjuvant 2 cycles, every two weeks (q2w) Nivolumab 240 mg i.v. over 30 min
15829899|NCT04205552|Drug|Relatlimab 10 MG/ML Intravenous Solution|Neoadjuvant 2 cycles, every two weeks (q2w) Relatlimab 80 mg i.v. over 30 min
15829900|NCT04205539|Drug|Dexmedetomidine|This medication will be administered sublingually using an LMA Intranasal Mucosal Atomization Device, which allows the medication to be administered in the form of a spray. Patients will be instructed to keep the medication in their mouth for about 2 minutes, or until fully absorbed. Pulse oximetry and blood pressure will be monitored throughout the duration of treatment. After the subject is asleep, the second DTI scan will be done.
15829901|NCT04205526|Device|Active rTMS|Patients randomized to receive actual rTMS treatment will receive 1Hz rTMS applied over contralesional M1 at an intensity of 120% resting motor threshold once daily for 30 minutes (approximately 1800 pulses) for a total of 15 sessions.
15829902|NCT04205526|Device|Sham TMS|For sham-stimulation, the TMS coil will be placed over the inter-hemispheric fissure at the vertex and stimulation will be performed with low intensity (10% resting motor threshold). This will cause similar skin sensations as real stimulation but will not induce currents in motor relevant areas.
15829903|NCT04205513|Device|Medly|Medly is a mobile phone-based telemonitoring system that enables patients with heart failure to take clinically relevant physiological measurements with wireless home medical devices and answer symptom questions on the mobile phone. The measurements are automatically and wirelessly transmitted to the mobile phone and then to a data server.
15829904|NCT04205500|Other|Specific carbohydrate diet|Specific carbohydrate diet (see arm description)
15829905|NCT04205487|Behavioral|Motivational Interviewing (MI)|Two motivational interviewing sessions focusing on stimulant use, sexual risk, and PrEP uptake will be delivered via Zoom.
15829906|NCT04205487|Behavioral|Contingency Management (CM)|CM will include financial incentives for PrEP clinical evaluation and filling a PrEP prescription.
15829907|NCT04205474|Diagnostic Test|graded bicycle test|the subjects perform an exercise test on a reclining bicycle, and perform against increasing afterload
15829908|NCT04205461|Procedure|Programmed ventricular stimulation|Programmed ventricular stimulation before pulmonary valve replacement. Voltage and activation mapping of right ventricle in a subset of patients.
15829909|NCT04205448|Behavioral|Physical exercize|10 weeks group exercize followed by community-based voluntary exercize
15829910|NCT04205435|Biological|β-globin restored autologous HSC|gene edited autologous hematopoietic stem cells with β-globin restoration
15829911|NCT04205422|Procedure|BIPAP|Biphasic Intermittent Positive Airway Pressure
15829912|NCT04205422|Procedure|APRV|Airway Pressure Release Ventilation
15829913|NCT04205409|Biological|Nivolumab|Given IV
15829914|NCT04205396|Behavioral|Written emotional disclosure|Participants will write five stories (days 8, 11, 14, 17 and 20) about an assigned topic relating to their experiences as a caregiver of someone with advanced liver disease. Rules for the exercise will be provided in an instructions page. Additionally, baseline and outcome measures will be completed.
15829915|NCT04205396|Behavioral|Resilience training|Participants will write three things that went well at the end of their day (before going to sleep), and what was their role in bringing them. These will be done about every three days (days 8, 11, 14, 17 and 20) for 2 weeks at home. Rules for the exercise will be provided in an instructions page. Additionally, baseline and outcome measures will be completed.
15829916|NCT04205396|Other|No treatment|Participants will complete baseline and outcome assessments and no intervention will be conducted.
15829917|NCT04205383|Other|biological analyses|The histones H3-citrullinated, acetylated histones (Pan-histones), H1 histone as well as the free HMGB1 protein will be quantified. This choice corresponds to the histones involved in inflammation, proliferation, migration or cell differentiation and can be quantified to date.
15829918|NCT04205370|Device|Deactivated Pregnancy Coach|Naturalistic monitoring of their typical sleep patterns and behaviors
15829919|NCT04205370|Device|Active Pregnancy Coach|The Pregnancy Coach will begin to deliver alerts when supine sleep is detected. Sleep metrics will be visible on the smartphone app.
15829920|NCT04205357|Drug|Sulfasalazine|Sulfasalazine combined with stereotactic radiosurgery
15829921|NCT04205344|Drug|Bupivacaine 5 mg|Receive subarachnoid hyperbaric bupivacaine at a dose of 5 mg
15829922|NCT04205344|Drug|Bupivacaine 10 mg|Receive subarachnoid hyperbaric bupivacaine at a dose of 10 mg
15829923|NCT04205331|Device|Assessing validity of ultrasound as regards correlation to Cormack-Lehane grading in obese patients|Assessing validity of ultrasound as regards correlation to Cormack-Lehane grading in obese patients
15830040|NCT04204278|Device|Monovisc|A chemically cross-linked sodium hyaluronate supplied as a 4-mL unit dose in a 5-mL glass syringe.
15829924|NCT04205305|Drug|conventional blood pressure control (labetalol, nicardipine)|After successful recanalization, appropriate antihypertension medication is administered to control systolic blood pressure <180 mmHg.
15829925|NCT04205305|Drug|intensive blood pressure control (labetalol, nicardipine)|After successful recanalization, appropriate antihypertension medication is administered to control systolic blood pressure <140 mmHg.
15829926|NCT04205292|Procedure|hysteroscopic|Women in the intervention group will receive an inpatient treatment with two-dose of Methotrexate followed by hysteroscopic resection under ultrasound guidance
15829927|NCT04205279|Other|Experimental: Treadmill training|Participants will be given thirteen slips and thirteen trips in stance and walking, followed by two slips and two trips at a higher intensity (posttest). Subjects would be consented if they would like to undergo fMRI pre and post-training. Participants not willing to undergo imaging would not be excluded. Three day training consisting of blocks of five consecutive gait-slips at varying intensities will be provided. Individuals with stroke would undergo an additional session (total 4 training sessions over 4 weeks (1session/week) since these individuals get easily fatigued and also might need more training sessions with sufficient rest interval to induce reactive adaptation. Training at a specific level will persist until the subjects show a recovery step response in at least 3/5 trials in a single block. Once subjects successfully adapt to this level, the perturbation intensity will be increased until they show a recovery response in at least 3/5 trials.
15829928|NCT04205279|Other|Experimental: Overground training|"Slips and trips could be induced under either of the limbs. The specialized walkway consists of two sliding platforms, each of which is mounted on two rows of low friction linear bearings (friction coefficient = 0.02). The base plate of each platform is bolted separately onto the top of a force platform embedded in the floor. An electronic-mechanical latch system is used to control the 2 states of the support platform; that is, the locked state for regular walking and the release state to initiate slipping are carefully controlled. The sliding top of the platform is released after the heel strike (vertical force to exceed 2% of the body weight). The slip distance would be adjusted between 30 to 60 centimeters depending upon the different population and their physical capacity."
15829929|NCT04205279|Other|Experimental: Surefooted training|During the first minute of each block, subjects would experience no perturbations followed by 3 minutes of single or multi-directional perturbations. A one minute break between each condition would be provided. Subject's fatigue would be assessed by Fatigue severity scale to determine the tolerability of 30 minute training protocol. The expected duration to complete the test would be a maximum of 1 hour including the preparation and training time.
15829930|NCT04205266|Drug|Ferumoxytol|IV iron infusion
15829931|NCT04205266|Drug|Ferrous Sulfate|oral iron therapy
15829932|NCT04205253|Diagnostic Test|Ultrasonography imaging|This study aimed to evaluate the tongue areas and compare the tongue areas before the implementation of rigid direct laryngoscope and after the rigid direct laryngoscope.
15829933|NCT04205240|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic hematopoietic stem cell transplantation
15829934|NCT04205240|Drug|Cyclophosphamide|Given IV
15829935|NCT04205240|Biological|Daratumumab|Given IV
15829936|NCT04205240|Drug|Fludarabine|Given IV
15829937|NCT04205240|Drug|Melphalan|Given IV
15829938|NCT04205240|Drug|Mycophenolate Mofetil|Given IV or PO
15829939|NCT04205240|Drug|Tacrolimus|Given PO or IV
15829940|NCT04205227|Drug|ENB003|ENB003 is selective Endothelin B Receptor Antagonist
15829941|NCT04205227|Drug|Pembrolizumab|anti-PD1
15829942|NCT04205214|Behavioral|Integrative Cognitive Behavioural Therapy|This intervention involves the psychological intervention of Cognitive Behavioural Therapy. This intervention also includes third wave psychological interventions of Mindfulness and Narrative Therapy which has been found to be helpful for people with chronic health conditions and chronic skin conditions.
15829943|NCT04205201|Drug|Drugs, Investigational|To see the safety and efficacy of topical latanoprost compared with topical brimonidine in the treatment of the primary open angle
15829944|NCT04205188|Other|therapeutic exercises|aerobic- balance -stretching and strengthening exercises
15829946|NCT04205162|Device|Verafilcon A|Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
15829947|NCT04205162|Device|Etafilcon A|Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
15829948|NCT04205149|Other|ERAS post-operative pathway|ERAS Pathway
15829949|NCT04205136|Drug|Spironolactone|If tolerated and serum potassium <5.0 meq/L, the dose will be increased to 50 mg (2 pills) after 4 weeks. If serum potassium is >5.0 but less than 5.5 or creatinine >4.0 mg/dL, the dose will be adjusted to 25 mg every other day; if potassium levels ≥5.5 in a non-hemolyzed blood sample, the medication will be discontinued.
15829950|NCT04205136|Drug|Placebo|Subjects assigned to the placebo group will take one pill for the first 4 weeks and a second pill for the remaining 8 weeks.
15829951|NCT04205123|Genetic|sickle cell syndrome|"Academic Study prospective multicenter observational factors responsible for nephropathy in patients with sickle cell disease followed by Belgium and the Nord-Pas -De- Calais Region and creating a biobank of blood and urine.
~In the population of patients with SCD followed in all participating centres.
~Know the prevalence of nephropathy and the relationship between it with their some of their genotypic mutations and clinical phenotype promoting mutated hemoglobin polymerization.
~Determine the behaviour of dense cells in the basal state and in a hypeosmolaire environment
~Determine the place of the erythrocyte microparticles as a biomarker of sickle cell nephropathy
~Studying genes known as risk factor for proteinuria
~Create a BioBank of samples of sickle cell patients in clinically stable condition for other research purposes."
15829952|NCT04205110|Diagnostic Test|PET-CT|PET-CT compared to intravascular imaging for assessment of atherosclerotic plaques in stable angina patients
15829953|NCT04205097|Drug|Neostigmine + glycopyrate|maintaining of moderate neuromuscular block (train-of-four count 1-2) during surgery, reversal using neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg
15829954|NCT04205097|Drug|Sugammadex|maintaining of deep neuromuscular block (posttetanic count 1-2) during surgery, reversal using sugammadex 2-4 mg/kg
15829955|NCT04205084|Device|Sanvita OneTouch Real Time Continuous Glucose Monitoring System|Sanvita OneTouch Real Time Continuous Glucose Monitoring System is an experimental glucose monitoring system that measures intersticial blood glucose and reports the glucose values in a reader
15829956|NCT04205071|Drug|Lorcaserin|Given PO
15829957|NCT04205071|Drug|Lorcaserin Hydrochloride|Given PO
15829958|NCT04205071|Other|Questionnaire Administration|Ancillary studies
15829959|NCT04205058|Dietary Supplement|Standard coffee|One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).
15829960|NCT04205058|Dietary Supplement|Caffeine-free coffee|One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).
15829961|NCT04205058|Dietary Supplement|Drinking water|One 30 mL espresso cup administered twice a day (08.00 a.m. and 02.00 p.m.).
15829962|NCT04205045|Diagnostic Test|Lactose Breath Test|Lactose Breath Test is performed during the recruitment step. Fasting subjects are asked to ingest 20 g of lactose in a 10% water solution. Breath samples are collected at baseline and every 30 min after lactose ingestion, for an overall test duration of 4 h. A cut-off value of 20 ppm over the baseline will be used to identify lactose malabsorbers.
15829963|NCT04205045|Other|Gut permeability test|A 3-sugar probes test is conducted by administering 5 g lactulose, 2 g mannitol and 2 g sucralose in water solution to fasting subjects. Urine are collected at baseline (before sugar ingestion) and for time periods 0-5 h and 5-24 h.
15829964|NCT04205045|Other|Milk Test|Milk test will be performed by administering to fasting subjects a portion of 250 ml of semi-skimmed milk treated with ultra-high temperature (UHT). Glycaemia measurements, blood withdrawals and questionnaires completion will be performed at baseline and repeated after 30 minutes, 1, 2, 4 and 6 hours after milk ingestion. Urine collection will be performed at baseline and for 6 time intervals after milk ingestion (0-2, 2-4, 4-6, 6-8, 8-12, 12-24 hours).
15829965|NCT04205032|Device|Test of the different devices integrated in cardiospace II|"The different devices included in CARDIOSPACE II will be tested
~Electrocardiogram
~Vascular Doppler
~LaserDoppler and iontophoresis
~Brachial blood pressure
~Continuous blood pressure recorded at the finger level
~Ultrasound
~Ambulatory Electrocardiogram / SAO2 (arterial oxygen saturation)"
15829966|NCT04205019|Biological|Neuro-Cells|Neuro-Cells is an autologous fresh stem cells containing product which modulates the secondary inflammation following a TSCI, reduces apoptosis (cell death) in the injured spinal cord, reduces scar tissue formation in the damaged spinal cord and creates a cell regenerative environment in the injured spinal cord.
15829967|NCT04204993|Device|Lumee Oxygen Platform|Two sensors will be inserted (one in the skin fo the upper arm and one on the side of the chest). A wireless patch reader is placed on top of the skin over the area where the sensor has been placed to measure local oxygen content.
15829968|NCT04204980|Drug|Daratumumab dose escalation|- Step I: dose-escalation 3 patients treated weekly during four weeks with 4 mg/kg of daratumumab, then 3 patients treated weekly during four weeks with 8 mg/kg of daratumumab, then 3 patients treated weekly four weeks with 16 mg/kg of daratumumab
15829969|NCT04204980|Drug|Daratumumab full dose|- Step II: expansion cohort to 13 patients (with 10 new patients included and the last 3 patients from the step I) with eight weekly doses of 16 mg/kg daratumumab
15829972|NCT04204954|Other|Tea Tree Oil Shampoo|Twice a day eyelid margin cleansing for three days.
15829973|NCT04204954|Drug|Ciprofloxacin Ophthalmic Ointment 0.3%|Applied topically in the eyelid margin every four hours for three days.
15829974|NCT04204954|Other|Baby shampoo|Twice a day eyelid margin cleansing for three days.
15829975|NCT04204954|Other|Blephaclean|Twice a day eyelid margin cleansing for three days.
15829976|NCT04204941|Drug|Tazemetostat|Tazemetostat/placebo will be administered twice daily..
15829977|NCT04204941|Drug|Placebo|Tazemetostat/placebo will be administered twice daily.
15829978|NCT04204941|Drug|Doxorubicin HCl|75mg/m2 intravenous injection cycles 1 to 6
15829979|NCT04204928|Drug|pralsetinib (BLU-667)|Pralsetinib will be administered orally (PO) at a dose of 400 mg once daily (QD) in continuous 28 day cycles
15829980|NCT04204915|Procedure|Aortic valve replacement|Participants will be assessed by a member of the surgical team performing aortic valve replacement (AVR), and by any other relevant medical professionals identified by the doctors overseeing their care in hospital. When deemed ready for AVR, a member of the surgical team will ask for consent to proceed with the AVR. They will discuss the surgical procedure, covering information on the basic technical procedure, risks and expected recovery time.
15829981|NCT04204902|Drug|Tepotinib 100 mg|Participants will receive a single oral dose of test treatment of tepotinib TF3 (5 * 100 mg) in either treatment period 1 or 2.
15829982|NCT04204902|Drug|Tepotinib 250 mg|Participants will receive a single oral dose of reference treatment of tepotinib TF3 (2 * 250 mg) in either treatment period 1 or 2.
15829983|NCT04204889|Drug|Oxaloacetic Acid|The first 3 patients will receive 500 mg twice daily, and subsequent cohorts will increase by 500 mg per dose to a maximum of 2500 mg twice daily.
15829984|NCT04204876|Diagnostic Test|Magnet Resonance Imaging (MRI)|MRI with and without Gadolinium contrast agent for the following vessels: thoracic aorta (ascending, arch, descending arch, left and right common carotic, subclavian, and vertebral artery)
15829985|NCT04204876|Diagnostic Test|PET/CT analysis|Standard value uptake measurement (SUV) based on quantitative score normalized to liver (SUV vessel max/liver mean) at the following vessel regions: Carotid artery: common, internal, external; Subclavian artery; Axillary artery; Vertebral artery; Thoracic Aorta; Abdominal Aorta; Common femoral artery; Deep femoral artery; Popliteal artery
15829986|NCT04204863|Other|collection of patient data|Extract data from the digital medical records, the electroencephalographic and microbiologic database.
15829987|NCT04204850|Drug|Cabozantinib|Cabozantinib is a multi-tyrosine kinase inhibitor with activity against VEGFR 1,2,3, MET and AXL, as well as RET, KIT, ant FLT-3.
15829988|NCT04204837|Drug|Nivolumab|Nivolumab will be given on Day 1 of every 14-day cycle (Q2W) at a dose of 240 mg as an IV infusion until progression, unacceptable toxicity or discontinuation for other reasons for up to 2 years.
15829989|NCT04204824|Other|Ultrasound and exercise|"The control group's ultrasound will be set at an intensity of 0 w/cm2. The first 3 treatments to the experimental group will be continuous ultrasound with an intensity of 1.0w/cm2 for 7 minutes. The next 6 treatments for the experimental group (2 times a week for 3 weeks) will have pulsed ultrasound at an intensity of 1.0w/cm2 with a 50% (1:1) duty cycle for 10 minutes. All will have a frequency of 3 MHZ.
~All participants in each group will be given specific exercises targeting intrinsic and extrinsic muscles of the foot and ankle. Exercises will be performed with a level of thera-band that is challenging to the individual participant in each plane of motion without increased pain for 3 sets of 10 repetitions each and one time each day independently at home during the duration of the treatment protocol (4 weeks) and recorded in an exercise log diary Specific stretches for the plantar fascia and Achilles tendon will be performed 3 times each for 30 second intervals and at home"
15829990|NCT04204811|Other|Prehabilitation|A program of personalized independent home exercises are outline for participants to complete daily. Prehabilitation coaching will continue weekly until admission for surgical tumor debulking or termination of neoadjuvant treatment for any reason.
15829991|NCT04204798|Drug|Dexmedetomidine|"Dexmedetomidine is infused from 4 pm to 8 am during ICU stay for no more than 3 days.
~For non-intubated patients, the infusion rate is adjusted to reach a Richmond Agitation-Sedation Scale (RASS) of -1, or a maximal rate of 0.2 microgram/kg/h, or the occurrence of any adverse events.
~For intubated patients, the infusion rate is adjusted to reach a RASS of -1, or a maximal rate of 0.7 microgram/kg/h, or the occurrence of any adverse events."
15829992|NCT04204798|Drug|Placebo|"Normal saline is infused in the same rate for the same duration as in the dexmedetomidine group.
~Propofol sedation is administered when considered necessary."
15829993|NCT04204785|Behavioral|Noise Reduction Education|OR staff will be offered education regarding the importance of minimizing noise in the OR. There will also be reminder signs and posters for the duration of the post-education period.
15829994|NCT04204772|Drug|Activated charcoal|Activated Charcoal, Powder, USP is carbon that has been treated to create low-volume pores that increase the area available for chemical reactions and adsorption. The most common pharmaceutical uses of activated charcoal is as a purification agent and antitoxin. All Spectrum Chemical USP products are manufactured, packaged and stored under current Good Manufacturing Practices (cGMP) per 21CFR part 211 in FDA registered and inspected facilities.
15829995|NCT04204759|Device|Transcranial direct current stimulation|Non-invasive stimulation will be conducted using a tDCS device (StarStim, Neuroelectrics, Spain).
15829996|NCT04204759|Device|Sham transcranial direct current stimulation|The same device will be used as in the active stimulation group, but stimulation will be terminated after 30 seconds.
15829997|NCT04204746|Other|We will observe and evaluate the temperature and moisture in the respiratory circuit by a thermo-hygrometer.|
15829998|NCT04204733|Behavioral|Mobile application|Mobile application that incorporates biosensor feedback, teleconsultation, and online group physical activity classes
15829999|NCT04204720|Device|needle (Chiba)|intravascular injection using chiba needle during caudal epidural block
15830000|NCT04204720|Device|needle (Whitacre)|intravascular injection using whitacre needle during caudal epidural block
15830001|NCT04204707|Other|PROMS|Patient Reported Outcomes after different types of surgery for rectal endometriosis
15830002|NCT04204694|Other|3-time blood sampling for septic shock patients|15 mL blood are sampled at day1, day 3 and day 7, from the arterial catheter inserted for all patients with septic shock
15830003|NCT04204694|Other|Only one blood sampling for controls patients|15 mL blood are sampled from a blood donation
15830004|NCT04204681|Diagnostic Test|Ultrasonography imaging|This study aimed to measure the tongue areas of the patients two times both of study and control groups with ultrasonography imaging to compare the tongue areas.
15830005|NCT04204668|Procedure|TMR|Surgical procedure to connect injured proximal nerve stumps to motor nerve branches directly innervating a muscle
15830006|NCT04204668|Procedure|RPNI|Surgical procedure to wrap the ends of injured nerves in small muscle grafts
15830007|NCT04204668|Procedure|VDMT|Surgical procedure that creates a small muscle graft that is both denervated and vascularized, which will then receive the damaged nerve ending
15830008|NCT04204655|Diagnostic Test|BIA|Bioelectrical Impedance Analysis
15830009|NCT04204642|Other|CAA patients data collection|Demographic and clinical data of each patient, including index event that led to the diagnosis (cerebrovascular disease, dementia, gait disturbance, TFNE, seizures, headache), vascular risk factors, history of brain injury or neurosurgery, familial history, and pharmacological treatment will be collected by neurologists in charge.
15830010|NCT04204629|Drug|HIP1601 40mg|Single dosing of HIP1601 40mg, PO
15830011|NCT04204616|Drug|Nemolizumab|Nemolizumab 30 mg will be administered as subcutaneous (SC) injection.
15830012|NCT04204603|Drug|CKD-506|Tablets for oral administration
15830013|NCT04204603|Drug|Placebo|Tablets for oral administration
15830014|NCT04204590|Other|Deprescribing algorithm|For this study an implicit, evidence-supported and patient-centred algorithm has been developed. The outcome of the algorithm is an advice to the doctor to deprescribe or not deprescribe the statin and/or PPI.
15830015|NCT04204577|Drug|Apatinib Mesylate|Evaluation of the efficacy and safety of simple local ablation, local ablation combined with apatinib, local ablation combined with apatinib and PD-1 antibody SHR-1210 for advanced liver cancer.
15830016|NCT04204564|Device|pactlitaxel PAD device|Peripheral vascular intervention on femoral-popliteal occlusive disease with paclitaxel and non-paclitaxel devices.
15830041|NCT04204265|Device|Monovisc|A chemically cross-linked sodium hyaluronate supplied as a 4-mL unit dose in a 5-mL glass syringe.
15830042|NCT04204252|Drug|Alpha 1-Antitrypsin|Kamada's alpha 1-antitrypsin product given by inhalation using the eFlow® electronic nebulizer manufactured by PARI Pharma GmbH
15830043|NCT04204252|Drug|Placebos|Preparation of NaCl in phosphate buffer solution with 0.01% TWEEN-80
15830202|NCT04203043|Drug|Pycnogenol Oral Product|pycnogenol use to prevent hyper pigmentation after foam sclerotherapy
15830017|NCT04204551|Behavioral|high-intensity interval training (HIIT)|Two 12-week HIIT cycles will be divided with 3 months of break. Each HIIT cycle will consist of three 1-hour training sessions weekly. Each 1-hour training session will consist of 10-minutes warm-up (at slow voluntary speed), 40-minutes of interval exercise and 10-minutes cool-down phase. The interval exercise part will consist of 10 sets of 4 minutes interval including 2-minutes cycling at ≥ 60 [rpm], but preferably at 80-90 [rpm] (fast phase of interval) and 2-minutes cycling at ≤ 60 [rpm] (slow phase of interval). The training will be performed on a stationary cycle ergometer (MONARK, Ergomedic 874E, Sweden). The heart rate (HR, [bpm]) will be measured by Polar system (Polar, Finland). The patients will pedal on the cycloergometer at 60%-80% of their individualized HRmax.
15830018|NCT04204551|Behavioral|conventional physical therapy|Conventional physical therapy as prescribed and provided by the National Health Fund of Poland, which includes activities for improving motor control, but without any kind of moderate or high intensity aerobic interval or continuous physical training (example: cycle ergometer, treadmill, or Nordic walking training)
15830019|NCT04204538|Other|Dietary habits|Data collected using food frequency questionnaire
15830020|NCT04204538|Other|Risk factors associated with metabolic syndrome|Data collected on nutritional status, biochemical indicators and other risk factors associated with metabolic syndrome
15830021|NCT04204525|Diagnostic Test|Quantitative sensory testing|"Electrical detection and pain thresholds will be determined (at the sural nerve of the dominant leg and at the median nerve of both arms) with a constant current electrical stimulator.
~Endogenous pain facilitation will be assessed by a temporal summation paradigm by delivering 20 electrical stimuli at the intensity of the electrical pain threshold.
~Endogenous pain inhibition will be assessed by a conditioned pain modulation paradigm with electrical stimulation as test stimulus and the cold pressor test as conditioning stimulus.
~EEG measurements with be performed with scalp EEG with 32 surface Sn electrodes in a headcap in referential montage following the standard 10-20 recording system.
~A 5 minute resting state measurement will be performed with eyes closed, followed by EEG measurements during the condition pain modulation paradigm to assess the evoked-related potentials."
15830022|NCT04204486|Behavioral|Exercise|Functional strength training, 1 hour, 3 times a week.
15830023|NCT04204473|Drug|TY-9591(10mg,40mg) qd. po|Increased dose cohorts from low dose to MTD(20mg Cohort1, 40mg Cohort2, 80mg Cohort3,120mg Cohort4, 160mg Cohort5, 200mg Cohort6)
15830024|NCT04204447|Other|Hepatitis C Educational Brochure|Subjects will receive information about Hepatitis C through a brochure
15830025|NCT04204447|Other|Hepatitis C Educational Video|Subjects will receive information about Hepatitis C through a video
15830026|NCT04204421|Other|Experience Sampling Method (ESM)|Experience Sampling Method (ESM) is a method for real time complaints assessment where people are asked to fill out a questionnaire 10 times per day at random moments. This will be done via a mobile phone application.
15830029|NCT04204395|Device|Peanut Ball|The participants in the experimental group will use the peanut ball at least every 2 hours, 30-minute usage for each time. More frequency will be available. Then, the participants will stop using the peanut ball when cervical os is dilated and effaced, may be ready to push.
15830030|NCT04204382|Drug|Levofloxacin Injection|Levofloxacin Injection 0.5 g each time, once a day, intravenous drip.Treatment course is 7 days.
15830031|NCT04204382|Drug|Compound Kushen Injection（CKI）|CKI, 20mL each time, once a day, intravenous drip. Treatment course is 7 days.
15830032|NCT04204369|Other|Ultrasound education curriculum|"Participants were enrolled in a musculoskeletal ultrasound course including 2 components:
~An online course (1-2 hours) to be done before the practical session. The videos were made available one (1) month prior to the practical course. This component reviewed the basics of ultrasonography, as well as the normal and abnormal appearance of relevant musculoskeletal structures (bone, tendon, ligaments, muscles, bursas, and nerves), and the ultrasound anatomy of high yield regions of the musculoskeletal system (shoulder, elbow, knee, ankle)
~A practical session (4-6 hours) done during one of the usual academic days of the orthopedic residency program. This session covered the use of the ultrasound; the examination of the shoulder, elbow, knee, and ankle; ultrasound-guided musculoskeletal injections and aspirations; and ultrasound-guided distal radius fracture reductions. Ample practice time was given to the residents using means such as phantom models, cadavers, and real patients."
15830033|NCT04204356|Behavioral|Language treatment for improving discourse production|All participants will receive a 6-week block of language treatment for improving verb retrieval in discourse production by a professional speech and language therapist. The treatment goals for this block of treatment are to 1) improve verb retrieval and language quantity and complexity in discourse production 2) improve functional communication skills and; 3) improve quality of life and psychological state in people with post-stroke chronic aphasia.
15830034|NCT04204356|Device|Transcranial direct-current stimulation (tDCS)|Transcranial direct-current stimulation is a non-invasive brain stimulation method that can modify spontaneous cortical activity in targeted brain regions. Anodal tDCS delivered through a positively charged electrode has been found to increase cortical excitability in a targeted brain region. The use of tDCS as an adjunct to speech and language therapy has been found to improve aphasia treatment effects in post stroke patient populations.
15830035|NCT04204343|Drug|Bupivacaine 0.7 ml/kg|Bupivacaine 0.25% 0.7 ml/kg
15830036|NCT04204343|Drug|Bupivacaine 0.5 ml/kg|Bupivacaine 0.25% 0.5 ml/kg
15830037|NCT04204330|Device|CardioQvark cardiac monitor and software, single-lead ECG|"Registration certificate for the medical device No. РЗН 2019/8124 dated February 15, 2019.
~Product form: phone case.
~Way of applying:
~Download the CardioQVARK mobile application; create a profile.
~Fill out the questionnaire:
~age;
~date of birth;
~sex;
~weight;
~height;
~blood type;
~eye color;
~hair color;
~occupation;
~town;
~alcohol consumption;
~tobacco use;
~overeating;
~insufficient sleep;
~hypertension;
~type 2 diabetes;
~pacemaker;
~the 10th revision of the International Classification of Diseases (ICD-10) code;
~medicines.
~Place index fingers on sensors that are on the case's backside and record 1-lead ECG of up to 3 minutes duration.
~Recorded parameters:
~time parameters of the ECG intervals (RR, P, PR, QRS, QT, QTc);
~abnormal rhythms;
~heart rate variability;
~additional function - blood pressure and blood sugar diary. All recorded and calculated parameters are passed to the server."
15830038|NCT04204304|Drug|Isotretinoin|ISO
15830044|NCT04204226|Behavioral|Social Worker|The social worker will discuss the clinician's recommendations for needed services and how to access the services. The family will be provided the social worker's contact information and be encouraged to reach out with more questions or if more information is needed.
15830045|NCT04204226|Behavioral|Autism Behavioral Health Navigation (ABHN)|The goal of the ABHN intervention is to ensure access to recommended community behavioral health services, decrease parent stress levels, and/or improve child sleep and activity levels in order to reduce disruptive behaviors. Navigators will check-in at least weekly by telephone, email, or text message (as per family preference) during the first 4 weeks of the intervention and at least every 2 weeks for the remainder of the intervention or until ABHN and family agree that all goals and action steps in the Family Care Plan are completed.
15830046|NCT04204226|Behavioral|Social work + ABHN|After 3 months, children whose ABC Irritability Subscale scores improve by less than 5 points who received the social work intervention can be randomized to ABHN
15830047|NCT04204226|Behavioral|Social work + ABHN + CAP|After 3 months, children whose ABC Irritability Subscale scores improve by less than 5 points who received the social work intervention can be randomized to ABHN+Complex Autism Program (CAP)
15830048|NCT04204213|Behavioral|Tai Chi Exercise|8 Section Brocade (Baduanjin) sitting Tai Chi classes + Healthcare Education seminars
15830049|NCT04204200|Dietary Supplement|liposomal vitamin C|The intake of liposomal vitamin C at 500 mg, in the morning and evening, one week before surgery, one during the day of surgery and lastly, during the first 21 post operation days.
15830050|NCT04204200|Dietary Supplement|standard vitamin C|The intake of traditional vitamin C with a daily intake of 500 mg in the morning and evening for 28 days (starting 7 days before the operative procedure, on the day of the surgery and ending twenty-one days after surgery).
15830051|NCT04204200|Dietary Supplement|placebo|The intake placebo was taken daily in the morning and the evening for 28 days (7 days before surgery, on the day of surgery and twenty-one days after the surgical procedure).
15830052|NCT04204187|Behavioral|service learning|service learning for university students
15830053|NCT04204174|Dietary Supplement|Tyrosine, brand name: myprotein|tyrosine at a dose of 100 mg/kg is then administered orally to the participants once
15830054|NCT04204161|Biological|CAR-T19/CAR-T22|According to tumor burden and other conditions, patients will be treated with cyclophosphamide or fludarabine,then,CAR-T cells will be infused 48-72 hours later.The recommand dose is 1x10^5/kg-2.5x10^8/kg .
15830055|NCT04204135|Procedure|LLIF or ALIF procedures|LLIF or ALIF procedures
15830056|NCT04204122|Drug|Vigamox|-FDA approved medication
15830057|NCT04204122|Drug|Placebo|-The placebo is artificial tear drops
15830058|NCT04204109|Other|Interprofessional case-based learning|"The trial is an educational intervention where groups of healthcare professionals receive the same case-based learning: one group receives case-based learning with healthcare professionals of various professional backgrounds (experimental) versus another group receiving case-based learning with healthcare professionals exclusively of the same professional background (control).
~The educational intervention consists of a case that is developed for the purpose of the intervention.
~The participants in the experimental group will be randomised into six teams who will receive interprofessional case-based learning. The experimental group will be made up of healthcare professionals from various groups. The participants in the control group will be randomised in groups of one profession"
15830059|NCT04204096|Biological|Vi-DT (Multi-dose formulation)|"Manufacturer: SK bioscience Co., Ltd.
~Dose formulation: 25 µg Vi polysaccharide /0.5 mL, presented in Type I glass vial (multi dose Vi-DT with preservative 2 PE)
~Mode of Administration: 0.5 mL by intramuscular injection in the left anterolateral thigh or left arm deltoid region in participants below 2 years of age, less dominant arm deltoid region in age group 2 to 45 years
~Storage Conditions: +2 to +8°C"
15830060|NCT04204096|Biological|Vi-DT (Single dose formulation)|"Manufacturer: SK bioscience Co., Ltd.
~Dose formulation: 25 µg Vi polysaccharide /0.5 mL, presented in Type I glass vial (single dose Vi-DT without any preservative)
~Mode of Administration: 0.5 mL by intramuscular injection in the left anterolateral thigh or left arm deltoid region in participants below 2 years of age, less dominant arm deltoid region in age group 2-45 years
~Storage Conditions: +2 to +8°C"
15830061|NCT04204096|Biological|Control Vaccine|"For participant ≥ 1 year one dose of locally licensed Meningococcal conjugate vaccine will be administered
~For participants 6 months to 1 year one dose of locally licensed Meningococcal conjugate vaccine will be administered during the study and the next dose will be provided after the study unblinding at the completion of 6 months follow up of last subject."
15830062|NCT04204083|Device|Monovisc|A chemically cross-linked sodium hyaluronate supplied as a 4-mL unit dose in a 5-mL glass syringe.
15830063|NCT04204070|Procedure|Accuro|A research coordinator recorded the depth of the EDS from skin, the number of attempts to perform the epidural anesthesia, the repositioning of the epidural needle either in the same space or in different space, the time taken for space localisation (it is defined as time taken in seconds from skin puncture until the successful space localisation).the total time of the procedure ( time measured from the patient is fully draped and in the proper sitting position till the end of insertion of the epidural catheter ) Any complications such as paresthesia during catheter insertion, dural puncture, blood in catheter and root irritation will be recorded
15830064|NCT04204070|Procedure|APAD|APAD
15830065|NCT04204057|Drug|Tenalisib|Tenalisib 800 mg BID, Orally
15830066|NCT04204044|Drug|Metformin Hydrochloride|Metformin Hydrochloride is used in PCO
15830067|NCT04204044|Drug|Myo-inositol|Myo inositol used in PCO
15830068|NCT04204031|Behavioral|Presentation of the adherence record|Adherence record will be presented to participants with an actual time of use less than prescribed. The participant will also be asked about the presence of possible barriers concerning the use of oxygen therapy. The collaborator in charge of home visits will attempt to resolve these barriers as much as possible.
15830069|NCT04204018|Other|Experimental Arm|"First, these providers will receive educational materials (e.g. a slide deck) meant to mimic what physicians will receive in the real-world market as they learn about the Progenity technology.
~Second, within each of their four cases, intervention-arm physicians only will receive simulated test results from the Progenity PE test at the clinically-appropriate point in each case."
15830106|NCT04203732|Procedure|Anesthesia Type|The anesthetic type either general anesthesia or neuraxial anesthesia is the intervention type for patients undergoing primary total joint arthroplasty of the knee or hip.
15830070|NCT04204005|Dietary Supplement|Probiotics|"Active composition: 5x109 of Bifidobacterium longum (mix DLBL), 1x 109 Lactobacillus reuteri LRE02 (DSM 23878) and maltodextrin (total 2 grams). The probiotic species employed were granted the Qualified Presumption of Safety (QPS) status by the European Food Safety Authority (EFSA) in 2007. Two envelopes per day and one envelope per day will be recommended for one and two months, respectively.
~Placebo composition: maltodextrin (2 grams). Two envelopes per day and one envelope per day will be recommended for one and two months, respectively."
15830071|NCT04203992|Behavioral|Videogame|"True Champion is an educational, values-based game that aims to empower young athletes to make informed decisions to avoid doping.
~Participants engaging in the videogame sessions will encounter a series of thought-provoking situations and knowledge tests. Players will help their assigned character navigate through these curriculum-rich scenarios in order to reach their performance goals in a healthy and ethical way."
15830072|NCT04203992|Behavioral|Control|Participants will be given an anti-doping booklet prepared by UNESCO. This booklet is considered standard educational material, i.e. what might be presented to young athletes as part of their regular sports curriculum.
15830073|NCT04203966|Diagnostic Test|12-item General Health Questionnaire (GHQ-12)|Structured validated screening tools to assess for the presence of CMDs, administered to participants who have consented to take part in the study by completing responses either via survey monkey, or if they prefer through paper questionnaires posted to them
15830074|NCT04203966|Diagnostic Test|WHO AUDIT (World Health Organization- Alcohol Use Disorders Inventory Tool)|Structured validated screening tools to assess for the presence of alcohol use disorders, administered to participants who have consented to take part in the study by completing responses either via survey monkey, or if they prefer through paper questionnaires posted to them
15830075|NCT04203953|Other|Early mobilization program|Early mobilization will be defined as any active exercise where the patients could assist with the activity using their own muscle strength and control that occurred within the first 7 days of trauma ICU admission and will be intended to maintain or restore overall function as well as being scored using the ICU mobility scale.15 The ICU mobility scale includes rolling, bridging, sitting, standing and walking, and upper and lower limb flexion and extension. In-bed therapies will include active or active-assist range of motion, bridge exercise, quadriceps setting, straight leg raising, rolling exercises and facilitation.
15830076|NCT04203940|Procedure|Cyanoacryale|mesh fixation was done using dots of N-butyl 2-cyanoacrylate tissue glue
15830077|NCT04203940|Procedure|Suture|mesh fixation was done with polypropylene 2/0 sutures
15830078|NCT04203927|Drug|Empagliflozin 25 MG|SGLT-2 inhibitor
15830079|NCT04203914|Drug|Empagliflozin Tablets|Add-on 25mg once daily
15830080|NCT04203901|Biological|CMN-001|Autologous Dendritic Cell Therapy
15830081|NCT04203901|Biological|Nivolumab+Ipilimumab|anti-PD-1 and anti-CTLA4 antibodies
15830082|NCT04203901|Drug|Lenvatinib+Everolimus|TKI+mTOR inhibitors
15830083|NCT04203888|Other|Swedish Massage|60-minute Swedish Massage delivered in-home by a licensed massage therapist, 2 times per week with at least 48-hours between massage interventions.
15830084|NCT04203888|Other|Yoga|"60-minute yoga session delivered in-home by a certified yoga instructor, 2 times per week with at least 48-hours between yoga interventions.Yoga sessions will be based on the yoga postures available in the appendix of the December 2005 Annals of Internal Medicine article, Comparing Yoga, Exercise, and a Self-Care Book for Chronic Low Back Pain (Sherman KJ et al., 2005)."
15830085|NCT04203875|Drug|Orencia® (Abatacept)|Orencia® (Abatacept) will be administered once a week for 6 months subcutaneously (injection under the skin) with an option to continue to receive Abatacept weekly injections for an additional 6 months, for a total of 12 months if there is a positive response.
15830086|NCT04203862|Drug|NPC-22|Single administration of low dose NPC-22
15830087|NCT04203862|Drug|NPC-22|Single administration of low/middle dose NPC-22
15830088|NCT04203862|Drug|NPC-22|Single administration of middle dose NPC-22
15830089|NCT04203862|Drug|NPC-22|Single administration of middle/high dose NPC-22
15830090|NCT04203862|Drug|NPC-22|Single administration of high dose NPC-22
15830091|NCT04203862|Drug|NPC-22 Placebo|Single administration of NPC-22 Placebo
15830092|NCT04203836|Drug|LEO 152020 Tablet|film-coated tablet
15830094|NCT04203810|Device|Ectoin® Mouth and Throat Spray Althaea Honey (ERS09)|4 puffs to be administered as needed several times a day for patients aged ≥ 12 years. A maximum of 10 applications per day should not be exceeded.
15830095|NCT04203810|Device|EMSER® Hals-und Rachenspray (throat spray)|1 to 3 puffs to be administered several times a day
15830096|NCT04203797|Drug|dupilumab|Pre-filled syringe administered by subcutaneous (SC) injections
15830097|NCT04203797|Drug|Matching placebo|Pre-filled syringe administered by subcutaneous (SC)
15830098|NCT04203784|Other|Plasma concentration measurements|Plasma concentration measurements
15830099|NCT04203771|Dietary Supplement|Probiotic AB-DENTALAC|Orodispersible tablets containing Lactobacillus plantarum [now Lactoplantibacillus plantarum] KABP051 (CECT7481) and Lactobacillus brevis [now Levilactobacillus brevis] KABP052 (CECT7480) as active ingredients, at a minimum dose of 5x10^8 cfu each, and sorbitol (E420) and guar gum (E412) as excipients, taken b.i.d. for 7 days.
15830100|NCT04203771|Other|Placebo|Orodispersible tablets made of sorbitol (E420) and guar gum (E412), taken b.i.d for 7 days.
15830101|NCT04203771|Procedure|Surgical removal of mandibular third molars at baseline|Surgical removal of both mandibular third molars, performed under intravenous sedation and loco-regional anesthesia (Articaine Hydrochloride 4% with Epinephrine 1:100.000), after having undergone a professional oral cleaning.
15830102|NCT04203771|Drug|Ibuprofen|Ibuprofen syrup at 20-30 mg/Kg of body weight, orally every 8 hours (t.i.d), for 7 days
15830103|NCT04203758|Other|Cereal products based on rye|Participants will receive a fixed amount of rye based cereals products, corresponding to approx 650 kcal/day.
15830104|NCT04203758|Other|Cereal products based on wheat|Participants will receive a fixed amount of wheat based cereals products, corresponding to approx 650 kcal/day.
15830105|NCT04203745|Device|Nonablative Fractional Diode Laser|The FRAX 1940 is a fractional 1940 nm solid-state diode laser that delivers linear arrays of microbeams to create nonablative microscopic treatment zones (MTZs) in the skin.
15830203|NCT04203043|Other|Placebo|Placebo
15830107|NCT04203719|Drug|AK105|AK105 is a humanized monoclonal antibody that specifically binds to PD-1. AK105 has a typical antibody structure and is composed of two lgG1 subtype heavy chains and two kappa subtypes light chains covalently linked by disulfide bonds.
15830108|NCT04203719|Drug|Anlotinib|a multi-target receptor tyrosine kinase inhibitor
15830109|NCT04203706|Other|Neurofunctional imaging|Subjects will be submitted to a functional neuroimaging scanning procedure
15830110|NCT04203693|Drug|Tildrakizumab|The study physicians will choose the treatment independently of the enrolment in the study according to routine care.
15830111|NCT04203680|Drug|HTK cardioplegic solution|30 ml/kg of HTK cardioplegic solution at 4°C through an antegrade fashion at an initial perfusion pressure of 80-100 mmHg
15830112|NCT04203680|Drug|blood cardioplegia|one liter of blood cardioplegia was given with the antegrade route at 30°C, or lower. Blood maintenance cardioplegia was repeated every 30-45mins
15830113|NCT04203667|Device|EndoRotor Resection|To collect data in support of the safety and performance of the Interscope EndoRotor® Endoscopic Mucosal Resection System on a post-market basis. The study will confirm that the EndoRotor resections are safe and effective in the removal of recurrent adenoma. post Endoscopic Mucosal Resection.
15830114|NCT04203654|Behavioral|cognitive-behavior group therapy|cognitive-behavior group therapy Frequency: thrice a week Treatment duration: 16 week
15830115|NCT04203654|Behavioral|Individual supportive psychotherapy|Individual supportive psychotherapy 3 sessions during the 16-week treatment period
15830116|NCT04203641|Biological|L-DOS47|A treatment cycle will be 28 days, with patients receiving L-DOS47 on Days 1, 8, 15, and 22.
15830117|NCT04203641|Drug|Doxorubicin|A treatment cycle will be 28 days, with patients receiving doxorubicin on Days 2, 9, 16 and 23
15830118|NCT04203628|Diagnostic Test|Xpert MTB/Rif Ultra on stool samples|"The Xpert MTB/Rif Ultra will be performed on stool samples processed using four different processing methods:
~Standard sucrose flotation method
~Optimized sucrose flotation
~Stool processing kit (SPK)
~Simple One-step method (SOS)"
15830119|NCT04203628|Diagnostic Test|Xpert MTB/Rif Ultra on respiratory sample|The Xpert MTB/Rif Ultra will be performed on gastric aspirate or expectorated sputum
15830120|NCT04203615|Device|Transcranial magnetic stimulation- sham rTMS|Transcranial magnetic stimulation- sham figure-eight coil will be used for stimulation. This sham coil will generate only clicking noise and will not generate any magnetic field.
15830121|NCT04203615|Device|Transcranial magnetic stimulation- real rTMS|Transcranial magnetic stimulation- figure-eight coil will be used for stimulation. 1 Hz stimulation, 100% of Resting Motor Threshold will be used.
15830122|NCT04203602|Procedure|telepresence discharge|Patients will be seen during ward rounds by the multidisciplinary team physically present, but with the surgeon remotely present via a telepresence robot.
15830123|NCT04203602|Other|Conventional discharge|Patients will be seen during ward rounds by the whole multidisciplinary team physically present, including the surgeon.
15830124|NCT04203589|Behavioral|The Explorer Baby Early Intervention Program|Centered based intervention, once or twice a month, 6 months follow up
15830125|NCT04203589|Other|Neurodevelopmental Therapy|Centered based intervention, once or twice a month, 6 months follow up
15830126|NCT04203576|Device|FIRE1 System|FIRE1 System
15830127|NCT04203563|Behavioral|Strong People Strength Training|A community-based progressive strength training program
15830128|NCT04203550|Procedure|Intraoperative irrigation|Operation with irrigation
15830129|NCT04203550|Procedure|No irrigation|Operation without irrigation
15830130|NCT04203537|Drug|CA-008|Single administration of CA-008 versus placebo
15830131|NCT04203524|Diagnostic Test|Procalcitonin Levels|Procalcitonin (PCT) will be measured within 48 hours of admission to the ICU or 48 hours of onset of sepsis (if developed during the ICU stay). In addition, the patients will have daily blood samples taken up to 5 days or until ICU transfer, whichever occurs first. A PCT-guided algorithm will be available to guide the management of patients in the PCT group.
15830132|NCT04203524|Other|Control|Procalcitonin (PCT) will be measured within 48 hours of admission to the ICU or 48 hours of onset of sepsis (if developed during the ICU stay). In addition, the patients will have daily blood samples taken up to 5 days or until ICU transfer, whichever occurs first.The results of the PCT levels obtained will be blinded and all clinical team members will not be able to access the results.
15830133|NCT04203511|Drug|Retifanlimab|INCMGA00012 administered intravenously every 3 weeks on Day 1 of each 21-day cycle for 4 cycles, followed by a consolidation part of INCMGA00012 administered intravenously on Day 1 of each 28-day cycle for up to12 cycles.
15830134|NCT04203511|Drug|Placebo|Placebo administered intravenously every 3 weeks on Day 1 of each 21-day cycle for 4 cycles, followed by a consolidation part of placebo administered intravenously on Day 1 of each 28-day cycle for up to 12 cycles.
15830135|NCT04203511|Drug|Pemetrexed|Pemetrexed administered intravenously every 3 weeks on Day 1 of each cycle with either carboplatin or cisplatin (nonsquamous NSCLC only) for 2 cycles (if radiation therapy is started on Cycle 1 Day 1) or 3 cycles (if radiation therapy is started after Cycle 1).
15830136|NCT04203511|Drug|Cisplatin|Cisplatin administered intravenously every 3 weeks on Day 1 of each cycle with either etoposide or pemetrexed (nonsquamous NSCLC only) for 2 cycles (if radiation therapy is started on Cycle 1 Day 1) or 3 cycles (if radiation therapy is started after Cycle 1).
15830137|NCT04203511|Drug|Carboplatin|Carboplatin administered intravenously every 3 weeks on Day 1 of each cycle with either pemetrexed (nonsquamous NSCLC only) or paclitaxel for 2 cycles (if radiation therapy is started on Cycle 1 Day 1) or 3 cycles (if radiation therapy is started after Cycle 1).
15830138|NCT04203511|Drug|Paclitaxel|Paclitaxel administered intravenously every 3 weeks on Days 1, 8, and 15 of each cycle with carboplatin for 2 cycles (if radiation therapy is started on Cycle 1 Day 1) or 3 cycles (if radiation therapy is started after Cycle 1).
15830139|NCT04203511|Drug|Etoposide|Etoposide administered intravenously every 3 weeks on Days 1-3 of each cycle with cisplatin for 2 cycles (if radiation therapy is started on Cycle 1 Day 1) or 3 cycles (if radiation therapy is started after Cycle 1).
15830140|NCT04203511|Radiation|Radiotherapy|Total dose of 60 Gy ± 10% (54 to 66 Gy) in 2 Gy daily fractions.
15830172|NCT04203238|Other|Reduced Meat High Potato Diet|The main entrée in the PLM arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with potatoes.
15830267|NCT04202471|Device|Chlorhexidine Cloth|2% chlorhexidine gluconate cloth
15830141|NCT04203498|Drug|Nabiximols|Nabiximols is a complex botanical medicine formulated from extracts of the cannabis plant that contains the principal cannabinoids delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD) and also contains minor constituents, including other cannabinoid and non-cannabinoid plant components, such as terpenes, sterols, and triglycerides.Nabiximols will be self-administered by participants as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
15830142|NCT04203498|Drug|Placebo|Placebo to match nabiximols will be presented as an oromucosal spray containing the excipients ethanol and propylene glycol (50% v/v) with colorings and flavored with peppermint oil (0.05% v/v). Each spray will deliver 100 microliters (μL) containing no active ingredients. Placebo will be self-administered by participants as an oromucosal spray in the morning and evening, up to a maximum of 12 sprays per day for 12 weeks.
15830143|NCT04203485|Biological|Camrelizumab 200mg|Camrelizumab 200mg q2w ivgtt
15830144|NCT04203485|Drug|Apatinib Mesylate 250mg|Apatinib Mesylate 250mg po qd
15830145|NCT04203485|Drug|Pemetrexed disodium for injection|Pemetrexed disodium for injection 500 mg/m2 q3w
15830146|NCT04203485|Drug|Paclitaxel injection|Paclitaxel injection 175 mg/m2 q3w
15830147|NCT04203485|Drug|Carboplatin|Carboplatin AUC 5 mg/mL/min q3w
15830148|NCT04203472|Device|Budesonid or budesonide/fomoterol administered by DPI|Miflonide Breezhaler 200 mcg or Oxodil Aerolizer 12 mcg
15830149|NCT04203472|Device|Budesonid or budesonide/fomoterol administered by MDI|Budiair 200 mcg or Atimos 12 mcg
15830150|NCT04203446|Other|Assessment of correctness of inhaling technique|Assessment of correctness of inhaling technique in patients with asthma or COPD
15830151|NCT04203433|Drug|DLX105-DMP|1mg applied to target lesion
15830152|NCT04203420|Other|screening and confirmatory tests|screening test is a blood test of the ratio of plasma aldosterone concentration(PAC) and direct renin concentration(DRC), confirmatory test is Captopril Challenge test
15830153|NCT04203407|Behavioral|ACP game|Participants in the intervention group will be divided into groups of 4 participants to play a 1-hour culturally-sensitive theory-driven ACP board game with 15-minute debriefing delivered by facilitators. The ACP board game is developed by the principle investigator in a previous project.
15830154|NCT04203407|Behavioral|Usual care|Participants in the control group will receive a 1-hour board game about health lifestyle.
15830155|NCT04203394|Other|Schroth Exercise Group|12 week , Exercises 1 hour, 2 times for a week with physiotherapist 20 minutes home exercise
15830156|NCT04203394|Other|Home Exercise Group|Home exercise 20 min at home Once, one hour to determine the Schroth program + teaching home exercises 20 minutes home exercise
15830157|NCT04203381|Device|GnRH Agonist|Forty participants who are transgender and who have been prescribed a gonadotropin-releasing hormone (GnRH) agonist by their physician will undergo magnetic resonance imaging (MRI), magnetic resonance spectroscopy (MRS), dual-energy x-ray absorptiometry (DXA) and peripheral quantitative computed tomography (pQCT) scans at baseline and at 12 months after initiation of the GnRH agonist therapy. This longitudinal observational study of two cohorts seeks to identify significant changes in bone marrow adiposity and bone density over 12 months. The same assessments will be obtained in 40 healthy control subjects matched for age, race/ethnicity and body mass index, all factors that are known to influence skeletal outcomes. The evaluations of bone marrow adiposity will be correlated with bone density measurements and the assessments of mood (validated anxiety and depression scales) and health-related quality of life, before and after pubertal blockade.
15830158|NCT04203368|Drug|adenosine|patients received IV adenosine 6 mg bolus then wait 2 minutes, if it failed to return to sinus rhythm then another 12 mg IV bolus of adenosine was administered, if supraventricular tachycardia persisted then the patient was shifted to verapamil.
15830159|NCT04203368|Drug|verapamil|patients received IV verapamil 5mg bolus slowly over 2 minutes followed by a second IV bolus dose of 5 mg ,10 minutes after the initial dose in case of persistence of supraventricular tachycardia (SVT). If SVT persisted, the patient was shifted to adenosine
15830160|NCT04203342|Drug|Experimental: Ketoconazole 2% Cream (Douglas Pharmaceuticals America Ltd.)|Topical treatment for tinea pedis. Subjects will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 +/- 4 days. Each subject is expected to receive 42 +/- 4 doses.
15830161|NCT04203342|Drug|Active comparator: Ketoconazole 2% Cream (Teva Pharmaceuticals USA)|Topical treatment for tinea pedis. Subjects will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 +/- 4 days. Each subject is expected to receive 42 +/- 4 doses.
15830162|NCT04203342|Drug|Placebo comparator: Placebo (Douglas Pharmaceuticals America Ltd.)|Topical placebo to treatment for tinea pedis. Subjects will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 +/- 4 days. Each subject is expected to receive 42 +/- 4 doses.
15830163|NCT04203329|Device|Femoral Venous Vascular Closure|Femoral venous vascular closure following catheter-based cardiac ablation a-fib cases utilizing 6-12 French inner diameter procedural sheaths at time of closure.
15830164|NCT04203316|Drug|Enasidenib|Given PO
15830165|NCT04203316|Drug|Enasidenib Mesylate|Given PO
15830166|NCT04203303|Other|Observational|Observational
15830167|NCT04203290|Drug|Bupivacaine|%0.25 bupivacaine solution
15830168|NCT04203290|Drug|Sevoflurane|End tidal sevoflurane concentration
15830169|NCT04203277|Other|IVY|a combination of practice education and quality improvement interventions
15830170|NCT04203264|Diagnostic Test|Real-time artificial intelligence identification system|The patients swallowed the MCE with a small amount of water in the left lateral decubitus position. Once the capsule reached the stomach after investigating the esophagus, it was lifted away from the posterior wall, rotated and advanced to the fundus and cardiac regions, and then to the gastric body, angulus, antrum and pylorus. The magnetic steering time for passing through the pylorus was not allowed more than 15 min. The real-time auxiliary system implemented real-time processing for the output image of MCE system. Professional operators guarantee the integrity of the examination and the diagnostic results of professional endoscopist was used as the gold standard. The system diagnosis results was recorded at the same time. The sensitivity, delay time, specificity of lesions and anatomical landmarks will be analyzed.
15830171|NCT04203251|Device|Caption Health Guidance Technology|
15830201|NCT04203056|Drug|AL-NCD|Aripiprazole Lauroxil 675 MG/2.4 ML Intramuscular Suspension, Extended Release
15830173|NCT04203238|Other|Reduced Meat High Pulses Diet|The main entrée in the LMP arm will consist of a menu item in which 40% of the meat in the original recipe will be replaced with pulses.
15830174|NCT04203225|Drug|LET Lidocaine (4%), Epinephrine (0.1%), and Tetracaine (0.5%) topical gel|Topical anesthetic
15830175|NCT04203212|Drug|Goserelin Acetate|Goserelin the a GnRH analog that will be administered to achieve menstrual cessation for 6 months
15830176|NCT04203199|Device|Real rTMS to the mPFC using H7 Coil|This will be delivered with the Brainsway H7 coil system; 1200 pulses with the H7 coil helmet. Blinded using active/sham operator cards.
15830177|NCT04203199|Device|Sham rTMS to the mPFC using H7 Coil|Sham stimulation will be administered using 'sham cards' provided by the Brainsway system for the H1/H7 coil. The sham coil still administers scalp sensations and acoustic artifacts but does not produce a magnetic field. Therefore, this treatment delivers no TMS. The visit for the group receiving sham treatment will otherwise be identical to the real TMS groups.
15830178|NCT04203199|Device|Real rTMS to the dlPFC using H1 Coil|This will be delivered with the Brainsway H1 coil system; 3000 pulses with the H1 coil helmet. Blinded using active/sham operator cards.
15830179|NCT04203199|Device|Sham rTMS to the dlPFC using H1 Coil|Sham stimulation will be administered using 'sham cards' provided by the BrainsWay system for the H1/H7 coil. The sham coil still administers scalp sensations and acoustic artifacts but does not produce a magnetic field. Therefore, this treatment delivers no TMS. The visit for the group receiving sham treatment will otherwise be identical to the real TMS groups.
15830180|NCT04203186|Drug|atovaquone-proguanil|Malaria standard treatment regimen
15830181|NCT04203173|Behavioral|FINANCE-DM|The FINANCE-DM intervention is comprised of: 1) nurse education, 2) home telemonitoring, and 3) structured financial incentives. Patients randomized to FINANCE-DM will be assigned the FORA 2-in-1 Telehealth System and provided glucose test strips to allow testing at least once a day. BG and BP will be measured daily and results will be uploaded to a secure server. A nurse educator will review the glucose and BP readings and use them to tailor and reinforce behavior change during weekly telephone-delivered diabetes education and skills training session. Participants will also receive financial rewards for: 1) uploading glucose measurements; 2) participating in telephone delivered educational sessions; and 3) absolute percentage drops in HbA1c from baseline at each 3-month follow-up intervals.
15830182|NCT04203173|Behavioral|Active Comparator|Patients randomized to the active comparator group will be assigned the FORA 2-in-1 Telehealth System and provided glucose test strips to allow testing at least once a day. BG and BP will be measured daily and results will be uploaded to a secure server. A nurse educator will review the glucose and BP readings and use them to tailor and reinforce behavior change during weekly telephone-delivered diabetes education and skills training session.
15830183|NCT04203160|Drug|CPI 613|Given intravenously
15830184|NCT04203160|Drug|Gemcitabine|Given intravenously
15830185|NCT04203160|Drug|Cisplatin|Given intravenously
15830186|NCT04203147|Behavioral|Supportive Therapy (Control)|Description: 8-weekly sessions of in-home, supportive therapy and monthly booster sessions from months 3-12 via telephone.
15830187|NCT04203147|Behavioral|Home DM-BAT|Description: 8-weekly sessions of in-home, culturally-modified, manualized diabetes-modified, behavioral activation treatment (Home DM-BAT) and monthly booster sessions from months 3-12 via telephone.
15830188|NCT04203134|Device|Mouthguard|The mouthguard is a thin clear acrylic protector fabricated from an impression of a patient's upper teeth and palate. The acrylic protector will be trimmed and will fit onto the patient's upper teeth and palate for use during the day, except when eating to minimize trauma to the tongue that exacerbates burning tongue pain.
15830189|NCT04203121|Radiation|low dose whole brain radiation to treat Alzheimer disease|"subjects 1-5 : 9Gy in 5 daily fractions
~subjects 6-10 : 5.4Gy in 3 daily fractions"
15830190|NCT04203108|Drug|ATG|In ATG group, ATG will be intravenously infused via a central venous catheter in day -1 at a dose of 2.5mg/kg.
15830191|NCT04203108|Drug|CsA|In both groups, CsA will be intravenously infused from day -9 and the dose was adjusted based on the concentration.
15830192|NCT04203108|Drug|MTX|In both groups, MTX will be intravenously on days +1(15mg), +3(10mg) and +6(10mg).
15830193|NCT04203108|Drug|MMF|In both groups, MMF will be administrated at a dose of 1.0g/d.
15830194|NCT04203095|Diagnostic Test|the level of plasma cfDNA CINs|The extracted cfDNA from PB will be analyzed by UCAD to determine the level of CINs.
15830195|NCT04203082|Behavioral|Exposure Intervention|Single session intervention of psychoeducation + exposure treatment to the operating room and procedural steps of a cesarean delivery
15830196|NCT04203082|Other|Usual Care|Standard of care for education about the cesarean /delivery planning varies across the two hospitals. At Children's Hospital Colorado, anesthesiologists are included in the delivery planning meetings where the patients have the opportunity to review anesthetic technique and ask questions.
15830197|NCT04203069|Device|Control group : Day-time compression sleeve|"In the control group, patients wear only day-time compression garment : lymphatrex during 3 months.
~The protocol will require 3 visits during the maintenance phase.
~Visit 1 at day 0 (until 5 days after the end of hospital): includes the inclusion visit with the reception of devices and some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group).
~Visit 2 at 30 days after the inclusion : includes some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group)
~Visite 3 at 90 days after the inclusion : includes some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group)."
15830198|NCT04203069|Device|Intervention group : Day-time compression sleeve and Night-time MOBIDERM® Autofit|"In the intervention group, patients wear a day-time compression garment : lymphatrex and the night-time compression garment : MOBIDERM AUTOFIT during 3 months.
~The protocol will require 3 visits during the maintenance phase.
~Visit 1 at day 0 (until 5 days after the end of hospital): includes the inclusion visit with the reception of devices and some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group).
~Visit 2 at 30 days after the inclusion : includes some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group)
~Visite 3 at 90 days after the inclusion : includes some evaluations (clinical examination, lymphedema volume, questionnaires, ultrasound on a patients sub-group)."
15830199|NCT04203056|Drug|Aripiprazole Lauroxil|12 month longitudinal aripirprazole lauroxil treatment and assessment follow-through
15830200|NCT04203056|Drug|ARI-ORAL|oral aripiprazole
15830204|NCT04203030|Behavioral|Physical Activity|Participants will meet in a weekly group session to discuss a topic related to physical activity and physical function and participate in group-based physical activity. Participants will also have instructions to participate in physical activity outside of the weekly sessions, incrementally increasing their total physical activity over the intervention period.
15830205|NCT04203017|Biological|allogeneic fecal microbiota|All patients receive autoHSCT with RIC (Cyclophosphamide, Antithymocyte globulin, Rituximab). After immune system reconstitution (approximately starting D+60 up to D+120), patients will receive FMT from healthy donor via po capsules.
15830206|NCT04203004|Procedure|HOPE with cytokine filtration by CytoSorb|Cytokine filtration during HOPE
15830207|NCT04202991|Other|Exposure - pain|Groups are defined by their naturally occurring exposure to pain or not
15830208|NCT04202978|Drug|Camrelizumab|Camrelizumab ：200mg intravenous injection d1 q3w
15830209|NCT04202978|Drug|Apatinib Mesylate|Apatinib：250mg/d P.O ,qd ,3weeks
15830210|NCT04202978|Drug|Capecitabine|capecitabine:850mg/m2 P.O ,bid ,d1-d14
15830211|NCT04202978|Drug|Oxaliplatin|oxaliplatin:130mg/m2 intravenous injection d1 q3w
15830212|NCT04202978|Radiation|radiofrequency ablation|radiofrequency ablation:between first cycle and second cycle percutaneous
15830213|NCT04202965|Drug|PTG-300|Active treatment with PTG-300 subcutaneously
15830214|NCT04202952|Drug|HEC110114 Tablet|administered orally once daily
15830215|NCT04202952|Drug|Sofosbuvir Tablet|administered orally once daily
15830216|NCT04202939|Other|nutrition|type and amount of food eaten or type of oral nutritional supplements as well as enteral or parenteral nutrition
15830217|NCT04202926|Device|real coil|active 10Hz with a train of 3s on / 17s off, 50 trains, a total of 1500 pulses
15830218|NCT04202926|Device|sham coil|sham 10Hz with a train of 3s on / 17s off, 50 trains, a total of 1500 pulses
15830219|NCT04202913|Behavioral|Coaching|Child will receive 1:1 coaching with health coach.
15830220|NCT04202900|Other|phototherapy protocol|"Pretest：Common symptoms in the elderly include insomnia, depression, pressure sore wounds, blood sugar, blood pressure, body temperature,fatigue,cold limbs.
~Intervention：LED light therapy for 6 weeks, 2-3 times a week, every 30 minutes. Post test：Common symptoms in the elderly include insomnia, depression, pressure sore wounds, blood sugar, blood pressure, body temperature,fatigue,cold limbs."
15830221|NCT04202887|Drug|Low Dose Fentanyl|10ml bolus: bupivacaine 0.1% + 25mcg fentanyl, followed by a solution of bupivacaine 0.083% + fentanyl 1mcg/ml
15830222|NCT04202887|Drug|High Dose Fentanyl|10ml bolus: bupivacaine 0.1% + 100mcg fentanyl, followed by a solution of bupivacaine 0.083% + fentanyl 2mcg/ml
15830223|NCT04202887|Device|Gastric Ultrasonography|"The Gastric US will be performed using a portable device with an abdominal probe by the same operator (EF) for all women. The Cross Sectional Area (CSA) of the antrum will be measured in the supine position with the head elevated 45 degrees. CSA will be calculated using the formula (AP x CC x pi)/4, where AC is the anterio-posterior diameter and CC the cranio-caudal diameter. Three consecutive measurements will be performed and the average of the three will be used as the final data. The cutoff used to define a full stomach will be a CSA above 381 mm2, which has been validated in previous studies on laboring woman. Gastric US will be performed immediately after verification of effective epidural analgesia (T0) and intrapartum, two hours after the first measurement (T2h), corresponding to a cumulative dose of 37-97mcg fentanyl in Group LF and 124-240mcg fentanyl in Group HF."
15830224|NCT04202874|Procedure|Surgeon-administered transversus abdominis plane (TAP)|Prior to fascial closure, the rectus muscle is gently elevated superiorly and the surgeon identifies its lateral border; the nerves that supply the anterior abdominal wall travel through the myofascial plane between internal oblique and transversus abdominis muscles, 2 fingerbreadths above the iliac crest. Access to this plane can easily be achieved by inserting a blunted needle through the parietal peritoneum; there is an appreciable loss of resistance ('one pop') and the correct plane is entered. After careful aspiration to ensure no vascular injury has occurred, 20 mL 0.25% bupivacaine or 20 mL of normal saline is injected slowly. The same procedure is repeated on the other side.
15830225|NCT04202861|Diagnostic Test|In vitro antibiotic combination testing (iACT)|CRGNB isolates from the index culture will be transported to the Pharmacy Research Lab,SGH for iACT testing. iACT results will be sent to the physicians and ID specialist managing the patient once completed. A subset of results will be published in the iACT report. Participants enrolled into the intervention arm -should ideally be kept on an iACT combination for the required treatment period. However during the treatment period, the treating doctor-in-charge and or the consulting infectious disease doctor may wish to continuing iACT antibiotic combination therapy or modifying the combinations based on their best clinical judgement for the patient.
15830226|NCT04202848|Diagnostic Test|Flora analysis|diversity and abundance of bacteria in patients who received malignant tumors
15830227|NCT04202835|Drug|Cyclophosphamide|Post Transplant Cyclophosphamide
15830228|NCT04202835|Drug|Anti-Thymocyte globulin (rabbit)|Anti-Thymocyte Globulin (rabbit, Thymoglobulin)
15830229|NCT04202822|Other|Oral soft tissues biopsies|Oral soft tissues biopsies (alveolar mucosa, buccal gingiva, and palatal tissue) will be harvested by the examiner at the time of the surgery (immediately before to start the surgical procedure -T0) and 24 hours after surgery (T24) at the level of the vertical released incisions (VRIs) with a biopsy punch with plunger of 2.0 mm diameter.
15830230|NCT04202809|Drug|Durvalumab|Durvalumab is given earlier as registered, during chemotherapy and radiotherapy in treatment Arm A
15830231|NCT04202796|Procedure|Catheter ablation|Catheter ablation of arrhythmia
15830232|NCT04202783|Other|Exosomes|Focused ultrasound delivery of intravenously-infused exosomes
15830233|NCT04202770|Other|Exosomes|Focused ultrasound delivery of intravenously-infused exosomes
15830234|NCT04202757|Biological|[21CFR640.30] Plasma from 18 - 25 year old volunteer donors|12.5 ml/kg intravenous NuPlasma yFFP, per each of two infusions (25 ml/kg total), in combination with ongoing normal standard treatment.
15830235|NCT04202757|Other|Saline|12.5 ml/kg intravenous 0.9% sodium chloride with 0.1% riboflavin , per each of two infusions (25 ml/kg total), in combination with ongoing normal standard treatment.
15830268|NCT04202458|Drug|intra-arterial tenecteplase administration|Intra-arterial administration of 4mg tenecteplase is given after microcatheter navigation through the clot. Intra-arterial administration of tenecteplase (0.4 mg/min) continuously is given after the first attempt of thrombectomy device pass for 30 minutes, and then followed by DSA.
15830236|NCT04202744|Other|Shoulder and core evaluations|Five main parameters of the shoulder were assessed: the flexibility of pectoralis minor muscle, tightness of the posterior shoulder capsule, glenohumeral range of motion of internal and external rotation (sum of internal and external rotation: total range of motion), the strength of rotator cuff muscles and scapula position. As core parameters, trunk muscle endurance (flexor, extensor, and laterals) and core stability were evaluated.
15830237|NCT04202731|Behavioral|PBS Study|Sleep extension intervention
15830238|NCT04202718|Diagnostic Test|VitalPatch Device|The VitalPatch® is an IRB (791130) and FDA approved wearable device that allows for the constant monitoring of biometric measurements and may have utility in the health management of individuals at high-risk for poor health outcomes and in the detection or prevention of adverse events within settings where more traditional telemetry monitoring devices are not currently in use.
15830239|NCT04202705|Drug|SYD1875|SYD1875 IV (in the vein) infusion every three weeks. Number of cycles: until cancer progression or unacceptable toxicity develops. Different doses.
15830240|NCT04202692|Device|Hyaluronic acid with chondroitin sulphate and magnesium trisilicate, 1100 mg melt in mouth tablet|1 tablet q.i.d. (three after meals, one before resting) for 3 consecutive weeks
15830241|NCT04202692|Device|Placebo 1100 mg, identically-looking melt in mouth tablet|1 tablet q.i.d. (three after meals, one before resting) for 3 consecutive weeks
15830242|NCT04202679|Drug|Dupilumab SAR231893|Pharmaceutical form:Injection solution Route of administration: Subcutaneous
15830243|NCT04202679|Drug|Placebo|Pharmaceutical form:Injection solution Route of administration: Subcutaneous
15830244|NCT04202679|Drug|Moisturizers|"Pharmaceutical form:
~Route of administration: Topical"
15830245|NCT04202679|Drug|Low to medium potent topical corticosteroids|"Pharmaceutical form:
~Route of administration: Topical"
15830246|NCT04202679|Drug|Topical calcineurin inhibitors|"Pharmaceutical form:
~Route of administration: Topical"
15830247|NCT04202666|Device|convex skin barrier|Total 300 patients and grouping in 1:1 ratio.(1)peristomy skin complication (30 mins) (2)life quality stomy care (3-5 mins) (3)stomy appliance satisfaction (3-5 mins)
15830248|NCT04202653|Drug|ETV|entecavir 0.5 mg qd
15830249|NCT04202653|Drug|TQ-A3334|TQ-A3334 po qw
15830250|NCT04202653|Drug|TQ-B2450|TQ-B2450 q3w iv
15830251|NCT04202640|Procedure|Mechanical Stimulation|The technique of mechanical stimulation alternates between compression and decompression of the treated area. It aims to reestablish a good blood circulation and lymphatic drainage.
15830252|NCT04202640|Procedure|Massages|"Massages will be carried out according to a specific regime as specified in the study protocol. The massages will be done in 15 sessions of 30 minutes each, done twice a week and will consist of:
~One part muscle exercise
~One part skin work (drainage)"
15830253|NCT04202601|Drug|Sintilimab|"Arms 1: Neoadjuvant therapy group 20 patients Drug: Sintilimab Weight<60Kg: 3mg/kg Q3W Weight>=60Kg:200 mg Q3W on Day 1 by IV infusion; Intervention：Perioperative Sintilimab+IBI310 are administered for 1-3 (6-18 weeks) cycles followed by 4 postoperative cycles (12 weeks) with Sintilimab monotherapy .
~Arms 2: first-line therapy group, 30 patients Drug: Sintilimab Weight<60Kg: 3mg/kg Q3W Weight>=60Kg:200 mg Q3W on Day 1 by IV infusion; Intervention：Sintilimab + IBI310 are administered for 1-3 (6-18 weeks) cycles followed by Sintilimab monotherapy for up to 2 years.
~Arms 3: ≥second-line therapy group, 30 patients Drug: Sintilimab Weight<60Kg: 3mg/kg Q3W Weight>=60Kg:200 mg Q3W on Day 1 by IV infusion; Intervention：Sintilimab + IBI310 are administered for 1-3 (6-18 weeks) cycles followed by Sintilimab monotherapy for up to 2 years."
15830254|NCT04202601|Drug|IBI310|"Arms 1: Neoadjuvant therapy group, 20 patients Drug: IBI310 1 mg/kg Q6W on Day 1 by IV infusion. Intervention：Perioperative Sintilimab+ IBI310 are administered for 1-3 (6-18 weeks) cycles followed by 4 postoperative cycles (12 weeks) with Sintilimab monotherapy .
~Arms 2: first-line therapy group, 30 patients Drug: IBI310 1 mg/kg Q6W on Day 1 by IV infusion. Intervention：Sintilimab + IBI310 are administered for 1-3 (6-18 weeks) cycles followed by Sintilimab monotherapy for up to 2 years.
~Arms 3: ≥second-line therapy group, 30 patients Drug: IBI310 1 mg/kg Q6W on Day 1 by IV infusion. Intervention：Sintilimab + IBI310 are administered for 1-3 (6-18 weeks) cycles followed by Sintilimab monotherapy for up to 2 years."
15830255|NCT04202575|Procedure|Tube clamping|Clamping of the tube between the additional and standard venous reservoir
15830256|NCT04202562|Procedure|Ab interno trabeculectomy|Ab interno trabeculectomy performed after pupil contraction and 90 degrees ablation of the nasal trabecular meshwork
15830257|NCT04202562|Procedure|Cataract|Cataract surgery with minimal clear cornea incision and phacoemulsification
15830258|NCT04202549|Drug|intra-arterial cocktail therapy|Intra-arterial administration of argatroban (0.2-0.3 mg/min), dexamethasone (0.1 mg/min) and edaravone (0.3 mg/min) for 30 to 60 minutes after thrombectomy.
15830259|NCT04202536|Drug|Besifovir Dipivoxil Maleate|Besifovir 150 mg q.d. + L-carnitine (L-Carn Tab. 330 mg) 660 mg q.d. Other Name: Besifovir®
15830260|NCT04202536|Drug|Tenofovir disoproxil fumarate(TDF)|300 mg tablet administered orally once daily Other Name: VIREAD®
15830261|NCT04202523|Radiation|Radiofrequency ablation|Liver cancer radiofrequency ablation is a clinical treatment method that uses electrode needles to penetrate the skin and liver into the tumor and completely destroy the tumor through the principle of heat production to achieve the purpose of treating tumors.
15830262|NCT04202523|Device|IMRT & SBRT|Tumor radiation therapy is a local treatment method using radiation to treat tumors. Radiation includes alpha, beta, and gamma rays produced by radioactive isotopes and x-rays, electron beams, proton beams, and other particle beams produced by various types of x-ray therapy machines or accelerators. Current mainstream radiotherapy technologies include stereotactic radiation therapy (SRT). Stereotactic radiation therapy (SRT) includes three-dimensional conformal radiation therapy (3DCRT) and three-dimensional conformal intensity modulated radiation therapy (IMRT).
15830263|NCT04202510|Procedure|Glaucoma and Cataract Surgery|Patients requiring combined cataract and glaucoma surgery will be randomized to either iStent, iStent Inject or Hydrus (to lower intraocular pressure) combined with Phacoemulsification (to remove cataract and insert intraocular lens) Eye Surgery
15830264|NCT04202497|Drug|TAK-418|TAK-418 orally.
15830265|NCT04202497|Drug|[18F]MNI-1054 (radiotracer)|[18F]MNI-1054 injection.
15830266|NCT04202484|Drug|Toripalimab combined with oxaliplatin and Tegafur,Gimeracil and Oteracil Porassium Capsules|Toripalimab: 240mg IV Q3W;Tegafur,Gimeracil and Oteracil Porassium Capsules: 40mg/m2 Bid PO×14d Q3W;Oxaliplatin: 130mg/m2 IV Q3W
15830269|NCT04202445|Drug|Ingenol mebutate|Topical field treatment as prescribed by dermatologist
15830270|NCT04202432|Diagnostic Test|Mean systemic filling pressure|"Peri- and postoperative measurement of continuous cardiac output with thermodilution derived pulse contour calculated device (PiCCO).
~Estimation of mean systemic filling pressure using a computerized algorithm and by creating venous return curves with inspiratory hold maneuvers, thereby extrapolating the VR-curve until mean systemic filling pressure is calculated."
15830271|NCT04202419|Device|FRAX 1940 nm laser|A fractional 1940 nm solid-state diode laser will deliver linear arrays of microbeams to create nonablative microscopic treatment zones (MTZs) in the skin, in order to treat pigmented skin lesions.
15830272|NCT04202406|Drug|Acetaminophen and codeine and caffeine|The patient will receive pretreatment oral single dose of Combination of 1000mg acetaminophen- 16mg codeine- 60mg caffeine 1 hour before treatment.
15830273|NCT04202406|Drug|Acetaminophen|The patient will receive pretreatment oral single dose of 1000mg acetaminophen alone 1 hour before treatment.
15830274|NCT04202406|Drug|Placebo|The patient will receive placebo (starch) 1hour before treatment.
15830275|NCT04202393|Behavioral|Integrated Treatment Adherence Program (ITAP)|Psychosocial support and treatment to improve treatment adherence, symptoms, and functioning.
15830276|NCT04202393|Behavioral|Safety Assessment and Follow-up Evaluation (SAFE)|Enhanced assessment and evaluation with clinician feedback.
15830277|NCT04202380|Drug|Azithromycin|Patients will receive Azithromycin orally 1000 mg
15830278|NCT04202380|Drug|Ampicillin|All patients will receive Ampicillin 2gm IV every 6 hours for 2 days
15830279|NCT04202380|Drug|Azithromycin|Azithromycin 500 mg orally once
15830280|NCT04202380|Drug|Azithromycin|Azithromycin 250 mg orally daily for 4 days
15830281|NCT04202367|Drug|1 mg.kg-1 bupivacaine 0.25%|Ultrasound-guided transversus abdominis plane block for unilateral inguinal hernia repair surgery.
15830282|NCT04202367|Drug|1 mg.kg-1 bupivacaine 0.125%|Ultrasound-guided transversus abdominis plane block for unilateral inguinal hernia repair surgery.
15830283|NCT04202354|Drug|ARO-HSD Injection|single or multiple doses of ARO-HSD by subcutaneous (sc) injections
15830284|NCT04202354|Drug|sterile normal saline (0.9% NaCl)|calculated volume to match active treatment, by sc injection
15830285|NCT04202315|Other|Virtual Reality|Utilizing Virtual Reality during external fixator removal in outpatient clinic setting.
15830286|NCT04202302|Procedure|IVF/ICSI|ovarian stimulation ，vaginal disinfection of flushing
15830287|NCT04202289|Device|Nile Tilapia Fish Skin|In the search of new therapies for burns, the skin of Brazil's most cultivated fish, the Nile tilapia, which was mostly a waste product (although sometimes used as a resistant material for artisanal handicraft), was suggested as a possibility for the development of a low-cost xenograft. Apart from non-infectious microbiota, Nile Tilapia Fish Skin presented histomorphological similarities with human skin in pre-clinical studies. It was shown to have a deep dermis formed by thick collagen fibers organized on parallel/horizontal and transversal/vertical arrangement and composed, in comparison, by larger amounts of type I collagen. Nile Tilapia Fish Skin did not present variations in its microscopic structure and tensile strength after glycerolization, irradiation and posterior rehydration, recovering its natural consistency after glycerol removal.
15830288|NCT04202289|Drug|Silver Sulfadiazine Cream 1%|Topical antibiotic commonly used for the treatment of superficial and deep partial-thickness burns.
15830289|NCT04202276|Other|diet assessment|Food frequency questionnaire to investigate differences in diet of children and adolescents with GERD compared to the age- and sex matched control group.
15830290|NCT04202263|Drug|Minocycline Topical|Placement of minocycline cream 0%, 1%, 2% or 3% at one of four identical allergen skin test sites.
15830291|NCT04202263|Drug|Placebos|Placement of minocycline cream 0%
15830292|NCT04202250|Procedure|CEMP (closed-ended multiport catheter) group|After sterile preparation and large inguinal crease draping, with the US probe in a sterile sleeve or cover , we will proceed to hydrolocalization with 5-10 mL 5% dextrose in order to open the space between the femoral nerve and the superior part of the ilio-psoas muscle. The Contiplex® FX Non-Stimulating Tuohy Set, 17Ga. x 3½ inches. the Non-Stimulating Needle and the closed-tip multiport catheter will be then inserted under control and its position assessed between the femoral nerve and the superior aspect of the ilio-psoas muscle. Some aliquots of 5% dextrose will inject to confirm correct dispersal of the solution along the femoral nerve. The catheter will be tunnelled subcutaneously.A patient-controlled analgesic device will be attached to the catheter for postoperative analgesia. continuous peripheral nerve patient-controlled analgesia is as follows: 0.125% bupivacaine; hourly infusion: 4 ml / hour, pca dose (bolus): 5 ml / hour, lock-up time: 30 min, 4-hours limit: 30 ml.
15830293|NCT04202250|Procedure|OESP (open-ended single port catheter) group|After sterile preparation and large inguinal crease draping, with the US probe in a sterile sleeve or cover , we will proceed to hydrolocalization with 5-10 mL 5% dextrose in order to open the space between the femoral nerve and the superior part of the ilio-psoas muscle. The Contiplex® FX Non-Stimulating Tuohy Set, 17Ga. x 3½ inches. the Non-Stimulating Needle and the open-ended catheter will be then inserted under control and its position assessed between the femoral nerve and the superior aspect of the ilio-psoas muscle. Some aliquots of 5% dextrose will inject to confirm correct dispersal of the solution along the femoral nerve. The catheter will be tunnelled subcutaneously. A patient-controlled analgesic device will be attached to the catheter for postoperative analgesia. continuous peripheral nerve patient-controlled analgesia is as follows: 0.125% bupivacaine; hourly infusion: 4 ml / hour, pca dose (bolus): 5 ml / hour, lock-up time: 30 min, 4-hours limit: 30 ml.
15830294|NCT04202237|Other|Speckle Doppler imaging|Speckle Doppler Laser imaging
15830295|NCT04202237|Other|Blood sample|Blood sampling
15830296|NCT04202224|Drug|Ibuprofen 400 mg and Acetaminophen 500 mg|Analgesia.
15830297|NCT04202224|Drug|Glucose|Placebo.
15830298|NCT04202224|Other|No drug|Standard surgical procedure without any preoperative medication.
15830299|NCT04202211|Biological|FMT oral|lyophilized FMT given orally (10 capsules) twice weekly for total of 8 weeks
15830300|NCT04202211|Biological|FMT enema|lyophilized FMT given via enema (1) twice weekly for total of 8 weeks
15830301|NCT04202211|Other|Placebo oral|placebo given orally (10 capsules) twice weekly for total of 8 weeks
15830302|NCT04202211|Other|Placebo enema|placebo given via enema (1) twice weekly for total of 8 weeks
15831076|NCT04195945|Drug|Liposome-encapsulated Daunorubicin-Cytarabine|Given IV
15830303|NCT04202198|Biological|A-PRF|local anesthesia was administered followed by placement of a hole in the alveolar mucosa adjacent to mesial most recession tooth. tunneling instruments are used to elevate a full thickness tunnel upto the CEJ sparing the tip of the papilla.previously prepared PRF membranes are placed through the access hole and the flap is advanced. 5-0 polyglycolic acid sutures is used to secure the advanced flap.
15830304|NCT04202198|Procedure|pinhole surgical technique only|local anesthesia was administered followed by placement of a hole in the alveolar mucosa adjacent to mesial most recession tooth. tunneling instruments are used to elevate a full thickness tunnel upto the CEJ sparing the tip of the papilla followed by advancement of the flap. 5-0 polyglycolic acid sutures is used to secure the advanced flap.
15830305|NCT04202185|Other|Data collection|Retrospective collection data from diagnostic Data collected following to medical exam as part of care
15830306|NCT04202185|Genetic|Genetic analysis|Research of mutation and identification of genetic panel as part of care
15830307|NCT04202172|Procedure|Stent implantation in the infart-related artery in patients with ST elevation myocardial infarction|"The 6-month scheduled coronary angiography will perform 3 interventions:
~Endothelial function assessment with intracoronary acetyl-choline infusion.
~Microcirculatory function assessment with a pressure wire during endovenous adenosine infusion.
~Stent healing assessment using optical coherence tomography"
15830308|NCT04202159|Drug|Perampanel|Perampanel tablets.
15830309|NCT04202159|Drug|Perampanel|Perampanel oral suspension.
15830310|NCT04202146|Behavioral|Contingency Management + Motivational Interviewing|Seven-day combined CM with two sessions of brief Motivation Interviewing (MI) followed by standardized individual drug counseling on cannabis use and relapse.
15830311|NCT04202133|Behavioral|WW (formerly Weight Watchers)|The WW intervention will consist of weekly group workshops for 16 weeks with WW Coaches and Guides.
15830312|NCT04202133|Behavioral|Waitlist|The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered the WW intervention
15830313|NCT04202120|Other|Age-related stereotyping priming|The priming intervention was performed using the E-prime 2.0 software (Psychology Software Tools, Pittsburgh, PA). To ensure the primes flashed on screen were beyond awareness, the similar adjustment procedure was taken (see Levy, 1996; Stein et al., 2002). After the trial block, participants were asked to try to report any words viewed during each trial. The stimulus onset asynchrony (SOA) will be reduced or enhanced whenever 2 words or above were correctly reported or no single word could be reported respectively. The priming SOA for this study ranged from 32 ms to 208 ms (M = 98.70 ms. SD = 48.60).
15830314|NCT04202120|Other|Non age-related stereotype priming|he priming intervention was performed using the E-prime 2.0 software (Psychology Software Tools, Pittsburgh, PA). To ensure the primes flashed on screen were beyond awareness, the similar adjustment procedure was taken (see Levy, 1996; Stein et al., 2002). After the trial block, participants were asked to try to report any words viewed during each trial. The stimulus onset asynchrony (SOA) will be reduced or enhanced whenever 2 words or above were correctly reported or no single word could be reported respectively. The priming SOA for this study ranged from 32 ms to 208 ms (M = 98.70 ms. SD = 48.60).
15830315|NCT04202107|Other|Food Frequency Questionnaire|Food frequency questionnaires (FFQs) are a common method for measuring dietary intake in large epidemiological studies, in particular in low literacy settings were diaries and food history would not be viable.
15830316|NCT04202107|Other|24 Hour food recall|Standardized and validated approach of collecting all foods, beverages, and supplements consumed during the past 24 hours
15830317|NCT04202094|Diagnostic Test|Physical examination|A physical examination to measure the patients' weight, height, body mass index, blood pressure and testicular volume using a Prader orchidometer and to determine the patients' Tanner stage (secondary sexual development).
15830318|NCT04202094|Diagnostic Test|Scrotum ultrasound|A scrotum ultrasound to measure the patients' testicular volume and to investigate potential abnormalities in the testicular parenchyma.
15830319|NCT04202094|Diagnostic Test|Blood sample|A morning blood sample to evaluate the serum levels of luteinizing hormone (LH), follicle-stimulating hormone (FSH), testosterone (T), estradiol (E2), inhibin B (INHB), thyroid-stimulating hormone (TSH), free thyroxine (FT4), insulin-like growth factor 1 (IGF1), prolactin (PRL), cortisol and adrenocorticotropic hormone (ACTH). Upon approval by the patient himself, a spare blood sample will be collected and retained for 5 years for subsequent research purposes limited to the context of the present study.
15830320|NCT04202094|Diagnostic Test|Semen analysis|A semen analysis to evaluate the ejaculate volumes, sperm concentration, sperm motility and sperm morphology. If sperm is found in the semen sample, an antisperm antibody test ((in)direct mixed anti-globulin reaction test) and a sperm DNA fragmentation test (TUNEL assay) will be performed. Upon approval by the patient himself, the surplus of the semen sample will be retained for 5 years for subsequent research purposes limited to the context of the present study.
15830321|NCT04202068|Drug|Ceftriaxone sodium and Sulbactam Sodium for injection|Ceftriaxone sodium and Sulbactam Sodium for injection is available as sterile powder for reconstitution.It will be administered as one 3g IV dose for adult or one 75mg/kg IV dose for children under 12.
15830322|NCT04202055|Other|Biomarker analysis|Detection of biomarker in cerebrospinal fluid
15830323|NCT04202042|Other|Psychological first aid|PFA responders (peer support workers) are trained to deliver 8 core actions: contact and engagement, safety and comfort, stabilization, information gathering, practical assistance, connection with social supports, information on coping, and linkage with collaborative services
15830324|NCT04202042|Other|Usual organisational intervention|Emergency intervention by workplace psychologist and limited therapeutic sessions with employee aid program
15830325|NCT04202029|Device|thoracic impedance monitoring|Thoracic impedance measurement identifies the respiratory frequence using the changes of impedance during inspiration and expiration via an ECG.
15830326|NCT04202029|Device|pulseoxymetry|Pulseoxymetry is meassuring the heart rate and the oxygen saturation in the arterial blood
15830327|NCT04202029|Device|non-invasive blood preassure monitoring|Non-invasive blood preassure is a method using a blood preassure cuff to identify the blood preassure.
15830328|NCT04202016|Procedure|Piezocision Surgery|After a surgical cut using #15 surgical blade 2-3 mm distal to the canine a pizocision using piezo-surgery device is made.
15830377|NCT04201639|Device|Verofilcon A contact lenses|Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
15830329|NCT04202003|Drug|TJ011133|This is an open-label Phase 1/2a clinical study. The study will be conducted in two parts: Part I: Phase 1 dose escalation, TJ011133 is tentatively scheduled to be administered once weekly in 28-day treatment cycles;Part II: Phase 2a study TJ011133 will be administered at a dose of 30 mg/kg once weekly, and AZA will be administered at a dose of 75 mg/m2 by subcutaneous injection for 7 consecutive days from D1 to D7 in 28-day treatment cycles.
15830330|NCT04201990|Drug|Camrelizumab and Apatinib|Camrelizumab, iv, Q3W; Apatinib, po, QD
15830331|NCT04201977|Other|Foam Roller Recovery|Myofascial self-release will be developed through the foam roller (FR), where participants will use a custom-made foam roller constructed from a hollow polyvinyl chloride tube that will have an outside diameter of 10cm and a thickness of 0.5cm and will be surrounded by neoprene foam with a thickness of 1cm. Each volunteer will be shown the technique for the 5 muscle groups involved and the technique used for each muscle group. FR will consist of 45s of rolling for each muscle in the left lower extremity, 15s of rest, 45s in the lower right extremity. They will be instructed to begin with the practice on the most distal portion of the muscle. They will be instructed to place as much tolerable body mass on the FR at all times and to roll their body mass back and forth along the roller as smoothly as possible at a rate of 50 beats per minute (ie , 1 rolling motion for 1 to 2s). The total technique time is estimated at 10 to 15min (PEARCEY et al., 2015).
15830332|NCT04201977|Other|Active recovery|Active recovery for 20 minutes (MIKA et al., 2016) will consist of pedaling on a stationary bike at a speed of 50 to 60 rpm. The load (49 ± 9 W) will be adjusted individually so that the heart rate is close to 100 bpm (about 50% of the theoretical maximum heart rate). This effort intensity is similar to that used in the literature (CRISAFULLI et al., 2003; FAIRCHILD et al., 2003; VANDERTHOMMED; MAKROF; DEMOULIN, 2010)
15830333|NCT04201977|Other|Immersion in cold water|Immersion in cold water will consist of the individual sitting in a plastic pool with water at the water level of the umbilical scar. Water temperature is between 11 and 15ºC, for a period between 10 and 15 minutes immediately after the exercise protocol (MACHADO et al., 2016b; MCDERMOTT et al., 2009). Water temperature will be controlled by adding or removing ice. This method has been applied by studies conducted by our research group (MISSAU; SIGNORI, 2017).
15830334|NCT04201977|Other|Passive recovery|Volunteers will be seated for 20 min after the resistance exercise session (TEIXEIRA et al., 2014a, 2014b).
15830335|NCT04201964|Drug|Intra-arterial administration of tenecteplase|Intra-arterial administration of tenecteplase (0.2-0.4 mg/min) immediately after thrombectomy device pass for 30-40 minutes.
15830336|NCT04201951|Drug|Tranexamic acid injection|Participant in group A will receive 2 ampules of 5 milliliters (mL) Tranexamic acid applied to 20 mL of 5% glucose water slowly intravenously immediately after the delivery of the fetus
15830337|NCT04201951|Other|Glucose water 5%|Group B will receive 30 mL of 5% glucose water slowly intravenously immediately after the delivery of the fetus
15830338|NCT04201938|Combination Product|Symbiter-Omega|Symbiter-Omega contains combination of flax and wheat germ oil (250 mg of each, concentration of omega-3 fatty acids 1-5%), supplemented with biomass of 14 alive probiotic strains: Lactobacillus + Lactococcus (6×1010 CFU/g), Bifidobacterium (1×1010/g), Propionibacterium (3×1010/g), Acetobacter (1×106/g) genera.
15830339|NCT04201938|Dietary Supplement|Placebo|Placebo
15830340|NCT04201925|Procedure|upper blepharoplasty|excision of excess eyelid skin with or without strip of orbicularis muscle ; with or without upper orbital fat
15830341|NCT04201912|Diagnostic Test|saliva analysis for Toll like receptor activity|Stimulated whole saliva will be obtained from patients and tested for Toll like receptor activity
15830342|NCT04201899|Dietary Supplement|No intervention - pure observation|Phosphate administration (yes or no)
15830343|NCT04201886|Other|serum calprotectin|serum calcium binding leucocyte protein
15830344|NCT04201873|Biological|Dendritic Cell Tumor Cell Lysate Vaccine|Given ID
15830345|NCT04201873|Biological|Pembrolizumab|Given IV
15830346|NCT04201873|Other|Placebo Administration|Given IV
15830347|NCT04201873|Drug|Poly ICLC|Given IM
15830348|NCT04201860|Diagnostic Test|Arterial blood gas analyses and haemostasis measures|Under aseptic conditions, a puncture of radial artery was performed: three mL of the arterial blood sample were used for the haemostasis measure, while one mL was tested for the blood gases analysis.
15830349|NCT04201847|Diagnostic Test|Serum test|Serum Fetuin A and fetuin B
15830350|NCT04201834|Drug|Risperidone|capsule or tablet, 0.5 mg
15830351|NCT04201834|Device|BioStamp nPoint device|MC10 has developed the BioStamp nPointTM, a FDA 510(k) cleared medical device. This multimodal, reusable and rechargeable biosensor uses flexible and stretchable electronics to enable unobtrusive wear on the body and monitoring in the home. The sensors have accelerometry, gyroscopy, and ECG/EMG capabilities. A docking station enables wireless recharging and data collection.
15830352|NCT04201821|Biological|fecal microbial transplantation (FMT)|Fecal microbial transplantation (FMT) is the infusion of intestinal microbiota from healthy donors.
15830353|NCT04201808|Drug|Tenofovir Alafenamide 25 MG|All patients will receive Tenofovir Alafenamide, 25mg PO, to treat chronic hepatitis B and their previous suboptimal response over the study duration of 48 weeks. Patients will be followed every 12 weeks for medication adherence, medication refill, and follow up as per standard of care.
15830354|NCT04201795|Other|Laser|laser with no emision will applied
15830355|NCT04201795|Other|pressure and traction tecnique|pressure and traction in plantar fascia with hands will be applied
15830356|NCT04201782|Drug|There are no disallowed treatments|Genetic: SB-728-T or SB-728mR-T No study drug is administered in this study. Subjects who received SB-728-T or SB-728mR-T in a previous trial will be evaluated in this trial for long-term safety and efficacy.
15830357|NCT04201769|Drug|Netupitant/Palonosetron|NEPA is adiministered 60 minutes before chemotherapy, on day 1
15830358|NCT04201769|Drug|Dexamethasone|"Intravenous dexamethasone 12 mg is administered 30 minutes before chemotherapy initiation, on day 1.
~The administration of DEX in the subsequent days (2-4) depends on the randomly assignement to treatment arm"
15830401|NCT04201470|Other|Neurologic / neuropsychologic tests - Patients|EDSS (Expanded Disability Status Scale), NHPT (Nine Hole Peg Test), T25FW (Timed 25-Foot Walk Test), 6MWT (Six-Minute Walk Test), CSCT (Computerized version of the Symbol Digit Modalities Test)
15830402|NCT04201470|Other|Neurologic / neuropsychologic tests - Controls|NHPT, T25FW, CSCT
15830403|NCT04201457|Drug|Dabrafenib|Dabrafenib capsule; Dabrafenib Dispersible Tablet
15830359|NCT04201756|Drug|Afatinib|"①Neoadjuvant treatment stage: the enrolled patients take afatinib at a dosage of 40mg per day, 8 weeks in total; and receive CT scan re-examination in the 3th post-therapy week (on the 14th-21th day).
~②Surgical treatment stage: the patients who respond to alfatinib treatment (CR+PR) and the patients who do not respond to alfatinib therapy but could still undergo surgery (SD and PD) will receive radical lung lobectomy+systematic lymph node dissection three weeks (22 days) later.
~③Adjuvant treatment stage: The CR, PR and SD patients who have been treated surgically will take alfatinib at a dosage of 40mg per day for 1 year. The SD and PD patients who could not receive operation and the PD patients who have received operation will be transferred into medical oncology or/and radiation oncology and receive comprehensive therapy (chemotherapy or/and radiotherapy, the regimen is designed by oncologist and radiologist)"
15830360|NCT04201743|Drug|Acellular amniotic membrane derived allograft injection (NuDYN)|Injectable acellular amniotic membrane derived allograft (NuDYN) through routine follow-up with physical examination, pain, function and quality of life measurements and compare dose effects (1 mL versus 2 mL of NuDYN injection) in the treatment of knee osteoarthritis.
15830361|NCT04201730|Procedure|Enhanced Recovery After Surgery （ERAS）|Preoperative education，Preoperative nutritional support，Preoperative bowel preparation，Preventative applying of antibiotics，Intraoperative warming，Goal-directed fluid therapy，Postoperative analgesia，Postoperative diet, drainage and activity management，Prevention of deep vein thrombosis.
15830362|NCT04201717|Procedure|laparoscopic assisted left colectomy|All patients underwent laparoscopic dissection according to the left hemicolon cancer resection standard. lymph nodes and blood vessels, are completely trimmed and resected in an en bloc fashion. The patients in the control group underwent with the traditional laparoscopic assisted technology. The free colon was taken out through a small incision in the middle of the abdomen or the outer edge of the left rectus abdominis. The mesentery was trimmed, the specimens were removed, and the anastomosis was completed. After the anastomosis, the whole surgical area was flushed and drainage tubes were left.
15830363|NCT04201717|Procedure|total laparoscopic left colectomy|All patients underwent laparoscopic dissection according to the left hemicolon cancer resection standard. lymph nodes and blood vessels, are completely trimmed and resected in an en bloc fashion. In the experimental group, the mesentery was endoscopically trimmed, the specimens were excised and the anastomosis was completed under the laparoscope. The specimens were taken out through trocar incision in the navel or in the right lower abdomen. After the anastomosis, all surgical area was flushed and drainage tubes were left.
15830364|NCT04201704|Other|Balanced crystalloid solution volume administration|Maintenance and bolus fluid volumes of balanced isotonic crystalloid solution administered based on arm.
15830365|NCT04201704|Other|Packed Erythrocytes Units, Blood Product Unit volume|For patients designated as Bleeding, where hemoglobin <7 then patient will be transfused 10 mL/kg up to 250 mL/transfusion. If patient is hypovolemic with clinician discretion transfuse 20 mL/kg.
15830366|NCT04201704|Other|Plasma volume|For patients designated as Bleeding, where International Normalized Ratio (INR) > 1.5 then patient will be transfused 10 mL/kg up to 250 mL/transfusion. If patient is hypovolemic with clinician discretion transfuse 20 mL/kg.
15830367|NCT04201704|Other|Platelets volume|For patients designated as Bleeding, where platelets < 50,000 then patient will be transfused 10 mL/kg up to 250 mL/transfusion. If patient is hypovolemic with clinician discretion transfuse 20 mL/kg.
15830368|NCT04201691|Other|classic rehabilitation|The intervention is conventional rehabilitation that included streching, balance and coordination training. The intervention is applied to participants, manually.
15830369|NCT04201691|Other|classic rehabilitation+mobilization|Another intervention is manuel therapy that included gliding technics, rotational technics at cervical region. (in addition to classic rehabilitation). The intervention is applied to participants, manually.
15830370|NCT04201678|Procedure|CLIA Group (conventional local anesthesia infiltration)|"The first step was to determine the pedicle to be vertebroplasty, and 5 mL of 1% Lidocaine Hydrochloride bilaterally to infiltrate the skin, subcutaneous tissue and a portion of the lumbodorsal muscles from a point of 1 cm to the pedicle projection point.
~In the CLIA group, the needle (50 mm 22 Gauge) was directed towards the laminar periosteum at the pedicular projection point at the 10-15 ° angle with the sagittal plane. A mixture of 3 mL of 2% Lidocaine Hydrochloride and 7 mL of 0.5% bupivacaine will be applied bilaterally."
15830371|NCT04201678|Procedure|EPIAA Group (Extrapedicular infiltration anesthesia)|"The first step was to determine the pedicle to be vertebroplasty, and 5 mL of 1% Lidocaine Hydrochloride bilaterally to infiltrate the skin, subcutaneous tissue and a portion of the lumbodorsal muscles from a point of 1 cm to the pedicle projection point.
~The anesthesia process of the CLIA + EPIA group also includes the third step called EPIA. For this stage, the anesthetic needle (50 mm 22 Gauge) is first drawn into the subcutaneous tissue, then through the lateral superior articular process to the lateral half of the pedicle and the upper border of the transverse process (5-10 degrees with sagittal plane and 5-10 with coronal plane), and after negative aspiration 3 mL 2% Lidocaine Hydrochloride and 7 mL 0.5% bupivacaine mixture will be applied bilaterally"
15830372|NCT04201678|Procedure|ESP Group (Erector Spina Block)|"The first step was to determine the pedicle to be vertebroplasty, and 5 mL of 1% Lidocaine Hydrochloride bilaterally to infiltrate the skin, subcutaneous tissue and a portion of the lumbodorsal muscles from a point of 1 cm to the pedicle projection point.
~In the ESP group, a high-frequency-50 15-6 MHz linear ultrasound probe will be placed vertically approximately 3 cm laterally at the point of application. Once the erector spinae muscle and transverse process have been identified, the peripheral nerve blockage needle (50 mm 22 Gauge) will be advanced from caudal to cranial between the fascia of the erector spina muscle and the transverse process. After 1 ml normal saline injection, this plane was opened. Bilateral 3 mL of 2% Lidocaine Hydrochloride and 7 mL of 0.5% bupivacaine will be administered."
15830373|NCT04201665|Drug|Carbetocin|Patients will receive a single dose of carbetocin 100 mcg (Pabal ®) at admission to high dependency obstetric unit after cesarean section.
15830374|NCT04201665|Drug|Oxytocin|Patients will receive 5 units of oxytocin ( Syntocinon ®) as a 250 ml 0.9% NaCl infusion at admission to high dependency obstetric unit after cesarean section.
15830375|NCT04201652|Procedure|Superficial local anesthetic infiltration|Superficial infiltration of local anesthetic for carpal tunnel release.
15830376|NCT04201652|Procedure|Deep local anesthetic infiltration|Deep and superficial infiltration of local anesthetic for carpal tunnel release.
15830404|NCT04201457|Drug|Trametinib|Tablet; Powder for Oral Solution
15830405|NCT04201457|Drug|Hydroxychloroquine|Tablet
15830378|NCT04201626|Procedure|Adapted ERAS|"Each woman in the intervention group will attend a preoperative counseling session with nurse and doctors. In addition to the standard preoperative counseling, explaining the purpose, process, and the importance of ERAS protocol compliance will be added to the session. Preoperative nutrition and laboratory assessment will be done according to adapted ERAS protocol on that same visit.
~During admission, the intervention group participants are provided with care according to adapted ERAS protocol including no bowel preparation, no extended fasting before surgery, balanced intravenous crystalloid, thromboprophylaxis, multimodal pain control reducing opioid usage, multimodal anti-emetics medications, stepping diet up to regular diet within 24 hours, chewing gum for post-operative ileus prevention, early removal of Foley's catheter, and promote early ambulation using care checklist plan."
15830379|NCT04201613|Device|Robotic exoskeleton|The Kinesiological Instrument for Normal and Altered Reaching Movements (KINARM) robotic exoskeleton used to provide therapy and assessment. The device has framework that supports the arms and the supports are adjustable to ensure a comfortable fit. Motors attached to the framework record shoulder and elbow movements and also move the arms.
15830380|NCT04201613|Behavioral|Usual Care|This group will receive standard care with no additional therapy.
15830381|NCT04201600|Device|Continuous Glucose Monitoring System (CGMS)|Continuous Glucose Monitoring System (CGMS)- minimally invasive sensors that measure glucose concentrations at 5-min intervals over several days.
15830382|NCT04201587|Other|Henna application|Henna application was performed to the patients in the intervention group. The patient was instructed to apply henna before going to bed at night, and after waking up in the morning (for an average of 8-10 hours) was instructed to wash with only water. The patient was asked to do this application at home after the second and third chemotherapy cycles. Thus, the patient applied henna twice in total (fifteen days apart).
15830383|NCT04201574|Drug|ALY688|ALY688 Ophthalmic Solution
15830384|NCT04201561|Drug|sodium selenite pentahydrate|High-dose inorganic selenium (2000 μg/40 ml) will be administered before chemotherapy in patients assigned to the experimental group.
15830385|NCT04201561|Drug|Normal saline|Normal saline (40 ml) will be administered before chemotherapy in patients assigned to the control group.
15830386|NCT04201561|Drug|Chemotherapy|Paclitaxel (175mg/m2), carboplatin (AUC 5.0 or 6.0) IV, and bevacizumab IV (15mg/kg) D1, every three weeks.
15830390|NCT04201535|Diagnostic Test|Protein arrays on plasma samples|Protein arrays on plasma samples obtained from RA, OA patients and controls will be performed to identify a panel of acute phase proteins, cytokines and chemokines present at systemic levels and to highlight analogies and differences in the systemic protein profile.The synovial fluid will be used to identify through high-throughput MudPIT the proteins present in the synovial fluid of RA and OA patients.
15830391|NCT04201522|Other|Normocapnic hyperpnoea intervention|Patients will perform for 6-weeks, 15 min twice daily, 5 days a week at 60% of the peak of minute ventilation, at home by means of a respiratory device (SpiroTiger, Idiag, Fehraltorf, CH).
15830392|NCT04201522|Other|Sham intervention|Patients will perform for 6-weeks, 15 min twice daily, 5 days a week at rest's minute ventilation, at home by means of a respiratory device (SpiroTiger, Idiag, Fehraltorf, CH).
15830393|NCT04201496|Combination Product|Empagliflozin + Control-IQ x 4 wks then Basal-IQ x 2 wks|Participants with be provided with Empagliflozin to take daily for approximately 10 weeks. Along with the study medication, participants will initially use the Tandem t:slim insulin pump with Control-IQ Technology for 4 weeks. Participants will then transition to using the Tandem t:slim insulin pump with Basal-IQ Technology for 2 weeks.
15830394|NCT04201496|Combination Product|Empagliflozin + Basal-IQ x 2 wks then Control-IQ x 4 wks|Participants with be provided with Empagliflozin to take daily for approximately 10 weeks. Along with the study medication, participants will initially use the Tandem t:slim insulin pump with Basal-IQ Technology for 2 weeks. Participants will then transition to using the Tandem t:slim insulin pump with Control-IQ Technology for 4 weeks.
15830395|NCT04201496|Device|No Empagliflozin + Control-IQ x 4 wks then Basal-IQ x 2 wks|Participants will initially use the Tandem t:slim insulin pump with Control-IQ Technology for 4 weeks. Participants will then transition to using the Tandem t:slim insulin pump with Basal-IQ Technology for 2 weeks. Empaglizflozin will not be provided to this group.
15830396|NCT04201496|Device|No Empagliflozin + Basal-IQ x 2 wks then Control-IQ x 4 wks|Participants will initially use the Tandem t:slim insulin pump with Basal-IQ Technology for 2 weeks. Participants will then transition to using the Tandem t:slim insulin pump with Control-IQ Technology for 4 weeks. Empaglizflozin will not be provided to this group.
15830397|NCT04201483|Other|DCE without RUSI feedback|Participants assigned to this group will perform an exercise known to selectively activate the semispinalis cervicis muscle
15830398|NCT04201483|Other|DCE + RUSI feedback about performance|Participants in this group will perform the same exercise as the DCE group to selectively activate the semispinalis cervicis muscle but receiving RUSI feedback about correct performance
15830399|NCT04201470|Other|Blood withdrawal|Measurement of serum neurofilaments light chain and GFAP
15830400|NCT04201470|Other|MRI|Cervical and cerebral MRI without contrast injection
15830406|NCT04201444|Diagnostic Test|Patient group|Patients with Cushing Disease (CD) receiving a medical treatment: n = 30 Plasmatic cortisol UFC Urine biocollection Salive biocollection
15830407|NCT04201444|Diagnostic Test|Remission control group|Patients in remission of CD and having recovered a normal pituitary function for at least 12 months following pituitary surgery (normal UFC associated to: cortisol suppression following dexamethasone suppression test, or normal LNSC, or midnight serum cortisol < 200 nmol/L) n = 15 Plasmatic cortisol UFC Urine biocollection Salive biocollection Haircortisol
15830408|NCT04201444|Diagnostic Test|Bilateral surrenalectomy control group|Patients with previous CD, treated with bilateral adrenalectomy and receiving weight adjusted doses of hydrocortisone for at least 6 months. Last daily dose of Hydrocortisone should be administered no later than 5 pm. n = 15 Plasmatic cortisol UFC Urine biocollection Salive biocollection Haircortisol
15830409|NCT04201431|Biological|PvDBPII/Matrix-M1|50ug PvDBPII in 50ug Matrix M1
15830411|NCT04201405|Drug|Autologous CD34+ cells transduced with a lentiviral vector containing the human SGSH gene|Autologous CD34+ haematopoietic stem cells from MPS IIIA patients will be genetically modified ex vivo using CD11b.SGSH Lentiviral vector (LV), a self-inactivating LV expressing the SGSH gene codon optimized for human use and regulated by a human CD11b myeloid-specific promoter. Cells will be cryopreserved prior to patient administration.
15830412|NCT04201379|Other|quality of life assesment|The sociodemographic and clinical characteristics of the individuals who meet the study criteria will be recorded. Evaluations of the participants will be done only once
15830413|NCT04201366|Other|No intervention|No intervention
15830414|NCT04201353|Behavioral|Conditional Cash Transfer|The intervention is a monthly cash transfer of 22,500 Tanzanian Shillings (~$10) for up to 6 months conditional on visit attendance.
15830415|NCT04201327|Behavioral|Project Jumpstart|PrEP focused intervention to improve PrEP related health outcomes
15830416|NCT04201314|Dietary Supplement|InnoSlim®|Subjects take 2 capsules before breakfast and 3 capsules before dinner of similar appearance per day for 6 weeks of a stage.
15830417|NCT04201314|Dietary Supplement|Placebo|Subjects take 2 starch capsules before breakfast and 3 starch capsules before dinner of similar appearance per day for 6 weeks of a stage.
15830418|NCT04201288|Behavioral|Acceptance-Based Behavior Therapy (ABBT)|Acceptance-Based Behavior Therapy (ABBT) In the first session, the interventionist will introduce the concept of acceptance and its possible benefits in the context of life values and participant-identified barriers to retention in care. Interventionists will help participants identify potential challenges to acceptance, including disclosure concerns. At the second session, participants will practice acceptance-based coping skills and a behavioral plan will be developed to target barriers identified in the first session. These discussions will help the participant clarify how best to align their values with decisions on how to manage their HIV.
15830419|NCT04201288|Behavioral|Enhanced-Treatment-as-Usual (ETAU)|ETAU will consist of two brief sessions lead by study interventionists, performed at the same times and by same methods as ABBT. Topics of education include safe sex practices, review of treatment options, and review of HIV-related indices of health.
15830420|NCT04201275|Drug|HEC74647PA capsule|Capsule administered orally once daily
15830421|NCT04201275|Drug|placebo|HEC74647PA capsule matching placebo administered orally once daily
15830422|NCT04201262|Biological|Ravulizumab|Participants will receive a weight-based loading dose of ravulizumab via IV infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until end of the Long-Term Extension Period.
15830423|NCT04201249|Drug|Piroxicam, lidocaine|Patients will be randomized to 2 groups group A - mesotherapy with piroxicam (20mg/ml, 1ml) and lidocaine (1%, 1.5ml) (treatment arm); group group B - mesotherapy without piroxicam
15830424|NCT04201249|Device|Mesotherapy without drug administration|Patients will be randomized to 2 groups group A - mesotherapy with piroxicam (20mg/ml, 1ml) and lidocaine (1%, 1.5ml) (treatment arm); group group B - mesotherapy without piroxicam
15830425|NCT04201236|Other|respiratory muscle strengthening exercise|These exercises strengthen locally inspiratory muscles. IMT can be done with threshold loaded devices.
15830426|NCT04201236|Other|oropharyngeal muscles strengthening exercise|These exercises strengthen locally oropharyngeal muscles. Oropharyngeal exercise can be done with some facial movements .
15830427|NCT04201223|Behavioral|FLARE Intervention|[See arm/group descriptions]
15830428|NCT04201210|Other|TCRα/β+ and CD19+ depleted haploidentical stem cell transplantation|Haploidentical 5+/10 HSCT from a relative, α/β T-depleted
15830429|NCT04201210|Other|Matched sibling donor transplantation|10/10 HSCT - matched family donor
15830430|NCT04201197|Drug|Inje cocktail|Acute drug exposure
15830431|NCT04201197|Drug|THC Cannabis extract|Acute drug exposure
15830432|NCT04201197|Drug|THC/CBD Cannabis Extract|Acute drug exposure
15830433|NCT04201184|Behavioral|Newly created cultural components, adapted Family Spirit lessons, adapted CETA modules|Caregivers will receive 12 lessons, weekly, over a period of 12 weeks. Full curriculum contains: 4 lessons on cultural connection and traditions, 4 lessons on parenting adapted from Family Spirit intervention, and 4 lessons on stress and trauma adapted from CETA. modules
15830434|NCT04201184|Behavioral|Active nutrition control|The six 30-minute voluntary nutrition education sessions will be taught one-on-one to parents and children at the school with information about where to obtain healthy foods. Parents will also be given healthy recipes and sample easy-to-make healthy foods with the children.
15830435|NCT04201171|Device|CSII and CGM|use of CSII as insulin delivery or CGM as glucose monitoring
15830436|NCT04201158|Diagnostic Test|Exercise Capacity|Modified Shuttle Walk Test
15830437|NCT04201145|Drug|Pembrolizumab|IV, predetermined dosage, twice per cycle
15830438|NCT04201145|Drug|Defactinib|Defactinib oral, twice daily, per predetermined dose and predetermined duration as defined by cohort
15830439|NCT04201132|Device|Carotid artery stenting with Neuroguard IEP System|Carotid artery stenting (treatment) with the Neuroguard IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection
15830440|NCT04201119|Device|Oxiris|Oxiris membrane used on the Prismaflex device (Baxter) dedicated to that type of membrane at blood pump flow of 450 ml min-1
15830504|NCT04200664|Diagnostic Test|Vestibular/balance assessment|Siderosis group participants will undergo vestibular/balance tests, including gait assessment and balance-specific questionnaires
15830441|NCT04201106|Behavioral|Open Label Placebo with Rationale|In the OLP + rationale group, the participants will be prescribed to take placebos for 2 weeks with the standard 4-point accompanying rationale: (1) the placebo effect is powerful, e.g. in clinical trials placebos are roughly 80% as effective as antidepressants; (2) classical conditioning is a possible mechanism for automatic self-healing - meaning that the body can automatically respond to taking placebo pills like Pavlov's dogs who salivated when they heard a bell; (3) placebo-treated patients who are more compliant have better outcomes, therefore the placebos should be taken faithfully; and (4) positive expectations increase placebo effects, but it is OK to have doubts.
15830442|NCT04201106|Behavioral|Open Label Placebo without Rationale|In the OLP without rationale group, the adolescents will be asked to take placebos for 2 weeks but they will be told that the pills contain inert substance and do not have any pharmacological effect.
15830443|NCT04201093|Drug|Tavapadon|Participants will be randomized to receive tavapadon 5 mg QD or 15 mg QD tablet once daily orally for 27 weeks.
15830444|NCT04201093|Drug|Placebo|Participants will receive placebo matching to tavapadon QD orally for 27 weeks.
15830445|NCT04201080|Drug|Part A: TRV250-20mg/ml|TRV250 SC Injections
15830446|NCT04201080|Drug|Placebo|Placebo SC injections
15830447|NCT04201080|Drug|Part B: TRV250 Dose 1|Dose 1of3 TRV250
15830448|NCT04201080|Drug|Part B: TRV250 Dose 2|Dose 2of3 TRV250 SC injections
15830449|NCT04201080|Drug|Part B: TRV250 Dose 3|Dose 3of3 TRV250 SC injections
15830450|NCT04201080|Drug|Placebo|Placebo SC injections
15830451|NCT04201054|Drug|Fluconazole|50 mg of fluconazole administered orally in a single dose.
15830452|NCT04201041|Procedure|pudendal nerve pulsed radiofrequency|received pudendal nerve pulsed radiofrequency through trans-vaginal approach or trans-gluteal approach
15830453|NCT04201028|Behavioral|Video Conferencing Health Coaching with devices|Devices
15830454|NCT04201028|Behavioral|Video Conferencing Health Coaching with no devices|No Devices
15830455|NCT04201015|Device|Heart rate optimisation using force frequency data|Programming heart rate rise according to the force frequency relationship
15830456|NCT04201002|Procedure|Resection plus intraoperative radiotherapy|En-bloc resection plus intraoperative radiotherapy
15830457|NCT04200989|Biological|Peanut allergen|Intralymphatic immunotherapy injections.
15830458|NCT04200976|Behavioral|Tele-CABA|"Tele-CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of Tele-CABA focus on learning about TBI and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
~The Tele-CABA intervention will be delivered over 10 weekly, 60-minute telephone sessions."
15830459|NCT04200976|Behavioral|Usual Care|Participants in the UC group will continue to receive their regular medical, psychiatric, and psychotherapeutic care.
15830460|NCT04200963|Drug|IK-175|Subjects will be administered IK-175 PO daily for every 21-day treatment cycle during the Single Agent Treatment dose escalation or for every 28-day treatment cycle during the Single Agent dose expansion.
15830461|NCT04200963|Drug|IK-175 and nivolumab|Subjects will be administered IK-175 PO daily and administered a single dose of nivolumab IV on Day 1 for every 28-day treatment cycle during the Combination Treatment dose escalation and expansion.
15830462|NCT04200950|Device|Previse|Machine learning algorithm for early acute kidney injury (AKI) prediction.
15830466|NCT04200924|Other|Biodex Balance System|For the computerized evaluation of postural control, Biodex Balance System will be used.
15830467|NCT04200924|Other|Balance Error Scoring System (BESS)|For the clinical evaluation of postural control, the Modified Balance Error Scoring System (BESS) will be used.
15830468|NCT04200911|Drug|Rapamune|Sirolimus 1mg capsules
15830469|NCT04200898|Device|Cheetah System|For each subject, surgeons will create an iLEX refractive correction using the investigational Cheetah femtosecond laser and Cheetah patient interface (regular or small diameter designs) on one eye (phase I) and one/both eyes based on refractive correction needs (phases II and III).
15830470|NCT04200885|Drug|Dexketoprofen Trometamol|Patients were instructed to record the number of drugs they used until the second and seventh postoperative days.
15830471|NCT04200885|Drug|Dexamethasone 21-Phosphate|Injections were administered in the immediate preoperative period as a single shot.
15830472|NCT04200885|Device|Therapeutic Elastic Bandage|The bands' lengths were individually measured and divided into five equal parts up to 2/3 of their lengths to obtain fan-type shape.
15830473|NCT04200872|Other|biological adjuvants|patients with aseptic pseudarthrosis clinically treated with biological adjuvants
15830474|NCT04200872|Other|no biological adjuvants|patients with aseptic pseudarthrosis clinically treated without biological adjuvants
15830475|NCT04200859|Other|Cold application|cold application using ice pack/gel pad in the control of pain experienced during chest tube removal
15830476|NCT04200846|Behavioral|Exercise intervention|Subjects in this group will be asked to exercise 5 days a week. Two days on-site with an Exercise Physiologist and the other 3 days at home.
15830477|NCT04200833|Drug|Golimumab|subcutaneous injection
15830478|NCT04200820|Diagnostic Test|Trampoline|During trampoline training that participants undergo constant change of vestibular stimulation. This triggers deep proprioception as well as other sensory inputs. This trigger might affect strength, body stability, muscle coordinative responses, joint movement amplitudes and spatial integration
15830479|NCT04200807|Device|Ultrasound Cardiac Output Monitor (USCOM 1A)|doplerometry with USCOM and echocardiograph is made for assessing central blood flow and spectroscopy with NONIN- for the blood flow in individual peripheral organs (brain and kidney)
15830480|NCT04200794|Behavioral|musical instrumental training|Learning to play a string instrument in a group setting (school class)
15830481|NCT04200794|Behavioral|sensitization to music|sensitization to music via listening, theory, moderate practice on small percussive instruments and choir singing in a group setting (school class)
15830482|NCT04200781|Drug|Granules of Shengdi Dahuang Decoction|Shengdi Dahuang Decoction contains Shengdi (rehmannia) and Dahuang ( rhubarb). Each pack of the granules of Shengdi Dahuang Decoction contains 15 grams of rehmannia and 5 grams of rhubarb.
15830483|NCT04200781|Drug|Placebo|Placebo granules has the same appearence, weight, shape and color as the experimental drug.
15830484|NCT04200768|Other|Prospective data and sample collection|Performance of measurements of adiposity, extra collection of blood samples
15830487|NCT04200729|Drug|Irrigation with PVI|The intervention will be irrigation with PVI, diluted to a concentration of 1% (containing 0.1% active iodine). After removal of the appendix from the patient's abdomen and attainment of hemostasis,10 mL/kg of 1% PVI solution will be used to irrigate the pelvis and right upper and lower quadrants. The solution will be left to dwell for 1 minute and then suctioned.
15830488|NCT04200729|Procedure|Usual care|The control will be usual care, which is expected to vary between institutions. The only stipulation for usual care will be that surgeons do not change their usual practice during the baseline period. Some surgeons utilize intra-abdominal irrigation while others use only local irrigation. Intraabdominal irrigation is defined as intraoperative instillation of a large volume (> 200 mL) of irrigation solution into all 4 quadrants of the abdomen. Local irrigation is defined as instillation of a small volume of liquid, typically <50 mL, in the operative field. Intra-abdominal irrigation is utilized with the intention of preventing IAAs while local irrigation is often used to confirm hemostasis or assist with suctioning thick purulent fluid.
15830489|NCT04200716|Behavioral|Moderate intensity continuous training - session|Moderate exercise continuous exercise 30 minuts session
15830490|NCT04200716|Behavioral|High intensity interval training - session|The high intensity interval exercise sessions are isocaloric to the moderate intensity continuous exercise, therefore, the necessary exercise time equivalent to 30 minutes of the moderate exercise continuous exercise session was calculated.
15830491|NCT04200703|Other|Adult and Child Survivor Centered Approach|Child welfare workers and supervisors, and community partners will be trained in the Adult and Child Survivor Centered Approach, and supervisors will receive ongoing coaching and training.
15830492|NCT04200690|Other|Interdisciplinary management|"The intervention in this trial consists of the combined efforts of the interdisciplinary team in the combined clinic arm.
~The interdisciplinary team consists of dermatologists, gastroenterologists, rheumatologists, nurses, psychologists, dieticians, social workers, physiotherapists, and secretaries. Treatment will be individualized based on clinical, biomarker, phenotypic, and psychosocial characteristics. The medical treatment will follow local, national and international guidelines."
15830493|NCT04200690|Other|Usual-care management|Usual care will be carried out by HCPs that are not otherwise involved in the trial. In usual care the patients will not be offered an interdisciplinary patient-centered care as described, but only attend their usual disease-specific departments at the usual appointments.Treatment will be prescribed as felt appropriate according to local, national and international guidelines by the treating physicians with no set protocol and no restrictions.
15830494|NCT04200677|Other|Monophasic Current (100 Hz) with 1ms pulse width applied to the Tibial Nerve|The participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following NMES parameters: (Monophasic Current, 100 Hz, pulse duration 1 ms, Ton: 6 s, Toff: 18 s)
15830495|NCT04200677|Other|Biphasic current (100 Hz) with pulse width 0.5ms applied to the Tibial Nerve|The participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Biphasic current, 100 Hz, pulse duration 0.5 ms, Ton: 6 s, Toff: 18 s)
15830496|NCT04200677|Other|Biphasic current (100 Hz) with 1ms pulse width applied to the Tibial Nerve|The participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Biphasic current, 100 Hz, pulse duration 1 ms, Ton: 6 s, Toff: 18 s)
15830497|NCT04200677|Other|Biphasic current (100 Hz) with 2ms pulse width applied to the Tibial Nerve|The participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Biphasic current, 100 Hz, pulse duration 2 ms, Ton: 6 s, Toff: 18 s)
15830498|NCT04200677|Other|Monophasic current (100 Hz) with 1ms pulse width applied to the Triceps Surae Muscle Belly|The participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Monophasic current, 100 Hz, pulse duration 1 ms, Ton: 6 s, Toff: 18 s)
15830499|NCT04200677|Other|Biphasic current (100 Hz) with pulse width 0.5ms applied to the Triceps Surae muscle Belly|The participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Biphasic current, 100 Hz, pulse duration 0.5 ms, Ton: 6 s, Toff: 18 s)
15830500|NCT04200677|Other|Biphasic current (100 Hz) with 1ms pulse width applied to the Triceps Surae Muscle Belly|The participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Biphasic current , 100 Hz, pulse duration 1 ms, Ton: 6 s, Toff: 18 s)
15830501|NCT04200677|Other|Biphasic current (100 Hz) with 2ms pulse width applied to the Triceps Surae Muscle Belly|The participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Biphasic current , 100 Hz, pulse duration 2 ms, Ton: 6 s, Toff: 18 s)
15830502|NCT04200677|Other|Biphasic current (25 Hz) with 0.5ms pulse width applied to the Triceps Surae Muscle Belly|The participants will perform 36 contractions evoked by neuromuscular electrical stimulation with the following current parameters: (Biphasic current, 25 Hz, pulse duration 0.5 ms, Ton: 6 s, Toff: 18 s)
15830503|NCT04200664|Diagnostic Test|Hearing assessment|All study participants will undergo hearing tests, including hearing-specific questionnaires
15831077|NCT04195945|Drug|Cladribine|Given IV
15830505|NCT04200664|Other|Quality of life assessment|All study participants will be asked to complete a set of quality of life questionnaires
15830506|NCT04200664|Diagnostic Test|Olfactory (smell) function testing|Siderosis group participants will undergo a formal smell identification testing by means of self-administered smell chart to identify the revealed scents
15830507|NCT04200664|Genetic|DNA bio-banking|Siderosis group participants will be asked to provide a saliva sample for DNA bio-banking
15830508|NCT04200651|Drug|Dexamethasone Ophthalmic Insert|DEXTENZA® is a 3mm long gel-like cylinder that is inserted in the punctum, a natural opening in the lower eyelid. DEXTENZA® is activated by the eye's moisture. DEXTENZA® delivers 0.4 mg dexamethasone, a liquid corticosteroid, onto the surface of the eye automatically for up to 30 days after eye surgery. Dexamethasone is used to reduce inflammation and eye pain. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.
15830509|NCT04200651|Drug|Prednisolone Acetate 1% Oph Susp|Prednisolone acetate 1% eye drops are used 2-4 times daily for 30 days as the current standard of care for treating inflammation and eye pain after cataract surgery. Prednisolone, like dexamethasone, is a steroid. This arm will also receive the standard of care topical ofloxacin eye drop antibiotic regimen.
15830510|NCT04200638|Diagnostic Test|ProTaper Next|The canal fluid sample before and after will evaluate after root canal instrumentation
15830511|NCT04200612|Behavioral|Equine-Assisted Psychotherapy|Equine-Assisted Psychotherapy (EAP) involves working on the psychological goals set between the client and the mental health professional. This is done through the experiential interactions between the clients and the horse. This experiential aspect is vital as it allows clients to process the emotions, thoughts and behaviors that were expressed during sessions with the horse.
15830512|NCT04200612|Behavioral|Equine-Assisted Activities|Simple interactions with the horses that does not necessarily involve any goals being set between the client and the personnel handling the session. These can involve activities such as grooming or petting of the horse.
15830513|NCT04200612|Other|Placebo-control group|This group will only be watching movies related to horses and they are told that this is another form of EAP even though this is not the case. This type of intervention has not been known to provide any therapeutic effect relevant to the study and thus is used as the placebo-control.
15830514|NCT04200599|Other|duration of initiation of oxytocin|mode of delivery
15830515|NCT04200586|Drug|Dapagliflozin|Dapagliflozin, one of the SGLT-2 inhibitors, will be prescribed to DM patients on clinical ground.
15830516|NCT04200573|Drug|Ampreloxetine|The study drug will be administered orally as a single Dose A tablet
15830517|NCT04200560|Other|Rhythmic Handgrip Exercise|60 minute rhythmic handgrip exercise
15830518|NCT04200560|Other|Chronic Exercise Training|Handgrip exercise training consisting of three 60-minute training sessions per week for eight weeks.
15830519|NCT04200547|Other|Immunomonitoring-based follow-up|"Post-operative follow-up of Crohn's disease patients will be done through the measurement of the residual rate of the drug adalimumab in the serum. Patients will receive adalimumab treatment every other week, starting 1 month after the surgery. 3 months after the surgery, serum levels of adalimumab will be measured:
~If the level is below 5ug/mL, adalimumab treatment will be increased to every other week until the end of the study.
~If adalimumab level in the serum is above 5ug/mL, the treatment's frequency will be maintained until the end of the study."
15830520|NCT04200547|Other|Standard follow-up|Post-operative follow-up of Crohn's disease patients will be based on clinical and biological parameters. Patients will receive adalimumab treatment every other week, starting 1 month after the surgery. If clinical relapse (CDAI > 220 together with an increase of 70 points) and biological relapse (CRP > 10mg/mL and fecal calprotectin > 100 ug/g) occur, frequency of adalimumab treatment will be increased to once a week.
15830532|NCT04200469|Diagnostic Test|Quantitative Flow Ratio (QFR) measurement|Quantitative flow ratio (QFR) is a novel approach enabling rapid computation of FFR pullbacks from three-dimensional quantitative coronary angiography (3D-QCA) without using a pressure wire.
15830535|NCT04200443|Drug|Cabozantinib|Given PO
15830536|NCT04200443|Other|Quality-of-Life Assessment|Ancillary studies
15830537|NCT04200443|Other|Questionnaire Administration|Ancillary studies
15830538|NCT04200443|Drug|Temozolomide|Given PO
15830539|NCT04200417|Procedure|Chemoembolization|Chemoembolization will be performed via the artery (bronchial, non-bronchial systemic, or pulmonary) that shows the greatest tumor enhancement on angiography. Chemoembolization will be performed using a lipiodol / mitomycin emulsion, followed by spherical particles.
15830540|NCT04200417|Drug|Mitomycin C|Mitomycin (5mg/m^2,maximum mitomycin dose 20 mg) will be dissolved in lipiodol at 2 mg/ml on the day of procedure.
15830541|NCT04200417|Drug|Lipiodol|Mitomycin (5mg/m^2,maximum mitomycin dose 20 mg) will be dissolved in lipiodol at 2 mg/ml on the day of procedure.
15830542|NCT04200417|Drug|Embospheres|Embospheres are non-resorbable spherical microspheres (trisacryl gelatin) that are FDA-approved for embolization of hypervascular tumors.
15830543|NCT04200404|Drug|CS1001|One course will last 28 days. CS1001 will be intravenously administered every 4 weeks (Q4W).
15830544|NCT04200404|Drug|Regorafenib|One course will last 28 days. Administration will be orally (p.o.) taken at different dose schemes.
15830545|NCT04200391|Other|Very low carbohydrate diet|"All meals will be delivered and participants will consume study foods exclusively. Participants will receive a fiber supplement with each meal as needed to promote digestive health, and a daily multi-vitamin, magnesium and omega-3 supplement to ascertain micronutrient sufficiency. Participants will be weighed at each study visit and the diet plan will be adjusted for satiety and weight-maintenance.
~The diet composition will be as follows: 5% carbohydrate, 75% fat, 20% protein."
15830546|NCT04200365|Drug|Itacitinib|Itacitinib will be administered orally once daily for up to 24 months.
15830548|NCT04200313|Device|Bionic Pancreas|iLet Bionic Pancreas System, which consists of an integrated infusion pump, touchscreen display, Bluetooth radio, and insulin dosing algorithms, that automatically controls insulin delivery based on glucose values obtained by communicating with a Dexcom G6 sensor.
15830549|NCT04200300|Diagnostic Test|Online questionnaire|Online questionnaire via SoSciSurvey
15830550|NCT04200287|Behavioral|Online decision aid tool|The decision aid intervention will be presented via a website
15830551|NCT04200274|Diagnostic Test|Online questionnaire|Online questionnaire via SoSciSurvey
15830552|NCT04200261|Drug|Banapenem|2000 mg group is performed firstly. After completion of observation and confirming that the drug can be safely tolerated, study on 3000 mg group is then performed
15830553|NCT04200261|Drug|sodium chloride|sodium chloride
15830554|NCT04200248|Drug|RBM-007 Injectable Solution|RBM-007 Injectable Solution
15830555|NCT04200248|Drug|Aflibercept|EYLEA® (aflibercept) Injection, for Intravitreal Use
15830556|NCT04200248|Drug|Sham|Sham intravitreal injection
15830557|NCT04200235|Drug|Dexmedetomidine hydrochloride nasal spray|"In the low weight group, 18 subjects will receive a low dose of dexmedetomidine nasal spray.
~In the high weight group, 18 subjects will receive a high dose of dexmedetomidine nasal spray."
15830558|NCT04200235|Drug|Dexmedetomidine hydrochloride nasal spray blank preparation.|"In the low weight group, 6 subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation.
~In the high weight group, 6 subjects will receive dexmedetomidine hydrochloride nasal spray blank preparation."
15830559|NCT04200222|Diagnostic Test|cadmium, lead and vanadium measurements and compare|"The method developed by Aliyev et al. was used for preparing the samples for analysis (1).
~The three metals (cadmium, lead and vanadium) were measured using inductively coupled plasma-mass spectrometry (Thermo Scientific ICAPQc, USA).
~1. Ovayolu A, Ovayolu G, Karaman E, Yuce T, Ozek MA, Turksoy VA. Amniotic fluid levels of selected trace elements and heavy metals in pregnancies complicated with neural tube defects. Congenit Anom (Kyoto). 2019:10.1111/cga.12363."
15830560|NCT04200209|Other|Implementation of a quality indicator feedback mechanism|"Audit and feedback: A summary of clinical performance and hospital safety culture over a specified period of time.
~Benchmarking Achievable: benchmarks are calculated from the performance of all members of a peer group and represents a realistic standard of excellence attained by the top performers in that group (i.e. comparing to the top 10% of peers).
~Educational outreach: A trained independent person or investigator will meet with health professionals or managers in their practice setting to provide information (e.g. feedback of quality indicators).
~Action planning: The purpose of action planning is to support quality improvement efforts by identifying opportunities for improvement, strategies and steps to accomplish the work."
15830561|NCT04200196|Procedure|"fabrique à histoire"|"Fabrique à histoire is a participatory entertainment method. Children of this arm going to create and listening a story before and during the venous puncture."
15830562|NCT04200196|Procedure|Usual care|It is a passive entertainment method. Children of this arm going to do habitual activities before and during the venous puncture, like to sing, blow up a balloon, to play with recreational thing, etc.
15830563|NCT04200183|Behavioral|iACTwithPain (ACT+compassion)|This intervention will deliver a eHealth ACT and compassion-based therapy (iACTwithPain) designed for chronic pain
15830564|NCT04200183|Behavioral|ACT-only intervention|This intervention will deliver the iACTwithPain intervention but without the delivery of explicit compassion.
15830565|NCT04200170|Device|Rose|Rose is a patient-centric, mobile mental health platform designed for in-between clinical mental health monitoring in form of mood tracking, clinical surveys and daily journaling. Rose is used as a participant-facing mobile app and clinician-facing dashboard. Each day, they complete mood and anxiety scales and update their journals. Biweekly, they are also asked to complete the PHQ-9 and GAD-7 assessments as well. The Rose mobile app sends timely self-help articles and notifications for users. The curated insights are selected based on participant responses to the daily mood and anxiety surveys, as well as a built-in sentiment analysis of the journaling. The clinical dashboard is a secure, web-based portal that has a unique login for each provider. Providers have access to only their patients through the system and are able to see all the health metrics collected with the Rose mobile app and the summarized metrics produced by our models.
15830566|NCT04200157|Other|Online survey|Subjects will complete a single survey that takes 5-10 minutes to complete
15830567|NCT04200144|Device|Endoscopic sleeve gastroplasty|Endoscopic sleeve gastroplasty with Overstitch (Apollo Endosurgery)
15830568|NCT04200131|Diagnostic Test|Biopsy of the cyst wall with the Moray™ forceps.|Tissue sample of the wall of the pancreatic cyst with micro Moray™ forceps during an ultrasound-guided puncture of a pancreatic cyst with a 19G needle.
15830569|NCT04200118|Other|Observational|non intervention
15830570|NCT04200105|Device|EBUS-TBNA|Mediastinal and hilar lymph node sampling using a standard 22G EBUS needle
15830571|NCT04200105|Device|Acquire TBNB|Mediastinal and hilar lymph node sampling using the Acquire TBNB needle
15830572|NCT04200092|Combination Product|0.5mg AZ-010|Subject will receive a single inhaled dose (0.5mg) of AZ-010 or matching Staccato Placebo
15830573|NCT04200092|Combination Product|1mg AZ-010|Subject will receive a single inhaled dose (1.0 mg) of AZ-010 or matching Staccato Placebo
15830574|NCT04200092|Combination Product|3mg AZ-010|Subject will receive a single inhaled dose (3.0 mg) of AZ-010 or matching Staccato Placebo
15830575|NCT04200092|Combination Product|AZ-010 1mg|2-period, 2-treatment open-label crossover design
15830576|NCT04200092|Drug|IV Granisetron 1mg|2-period, 2-treatment open-label crossover design
15830648|NCT04199468|Drug|Placebo Delta-9-THC|A placebo dose given intravenously (IV)
15830577|NCT04200066|Drug|Temozolomide, Tamoxifen, Maprotiline|Subjects will receive a combination of temozolomide and tamoxifen for two weeks. After that, they will receive a combination of temozolomide, tamoxifen and maprotiline for the remainder of the study. All drugs are administered orally. Subjects will undergo visits at the beginning of week 3, week 5 and week 7 that will involve multiple blood draws and ECGs to evaluate for pharmacokinetics and drug interactions. Response will be assessed every two months with an MRI and patients will continue on study as long as their tumors are under control and they are tolerating the regimen.
15830578|NCT04200053|Other|Reflexology massage|Before the burn dressing, a reflexology massage will be performed for 20 minutes on the right foot and 20 minutes on the left foot. This intervention will continue in the morning for 3 days.
15830579|NCT04200053|Other|Reflexology massage and passive music|Before the burn dressing, a reflexology massage and passive music will be performed for 20 minutes on the right foot and 20 minutes on the left foot. Instrumental music will be played during the massage. This intervention will continue in the morning for 3 days.
15830580|NCT04200040|Biological|OrienX010 injection|"OrienX010 to be used in this study have been developed and manufactured by OrienGene Biotechnology Ltd.
~Dacarbazine to be used in this study was manufactured by Sinopharm A-Think Pharmaceutical Co., Ltd."
15830581|NCT04200040|Drug|Dacarbazine (DTIC)|Dacarbazine to be used in this study was manufactured by Sinopharm A-Think Pharmaceutical Co., Ltd.
15830582|NCT04200027|Procedure|total mesorectal excision|Total Mesorectal Excision Total Mesorectal Excision is currently the standard technique for surgical treatment of RC. It was first described in 1982 by Bill Heald, and relies on the excision of the whole mesorectum within an intact mesorectal fascia, with the contained lymphatic system along with the tumour bearing bowel segment Total mesorectal excision
15830583|NCT04200001|Other|Quality of life|"The patient will receive the following questionnaires to be completed :
~EORTC QLQ-C30
~EORTC QLQ-BR23
~EORTC SHQ-C22
~CUPIDON 2 specific questionnaire"
15830584|NCT04199988|Diagnostic Test|Posterior Shoulder Endurance Test|"Isometric posterior shoulder endurance test: In the prone position, the athlete's shoulder will be placed at horizontal abduction, and the time for maintaining this position will be recorded.
~Isotonic shoulder endurance test: In the prone position, the athlete's shoulder will be placed at horizontal abduction and asked to perform horizontal adduction-abduction, and the athlete will horizontally abducted-adducted his/her arm to 90 degrees at a cadence of 30 beats per minute. The number of repetitions will be recorded."
15830585|NCT04199975|Device|Orthoses|Power-Driven or Mechanical Orthoses
15830586|NCT04199949|Behavioral|Inactivity|On days 1 and 6 of each main trial, the participants will be asked to attend the laboratory after an overnight fast of at least 8 to 12h to undergo brachial and popliteal arteries FMD measurements (30 min apart) using duplex-Doppler ultrasound, followed by assessment of the hand grip strength of their non-dominant hand using a hand dynamometer.
15830587|NCT04199936|Device|Electrical Muscle stimulation|Electrical muscle stimulation
15830588|NCT04199923|Behavioral|Single leg immobilisation|Immobilisation with single leg suspension immobilisation
15830589|NCT04199910|Other|There is no intervention, only research blood samples are collected|Research blood samples collected
15830590|NCT04199897|Dietary Supplement|Succrose rinsing|Sucrose rinsing 7-8 times a day for 14 days
15830591|NCT04199897|Dietary Supplement|Probiotic lozenges|Probiotic lozenges 2 times a day for 35 days
15830592|NCT04199897|Other|xylitol rinsing|Xylitol rinsing 7-8 times a day for 14 days
15830593|NCT04199897|Other|Placebo tablets|Placebo lozenges 2 times a day for 35 days
15830594|NCT04199884|Behavioral|Active IU-focused Psychoeducation Intervention|This paradigm was an IU-focused psychoeducation intervention wherein participants were provided psychoeducation about the nature of IU and anxiety, given strategies to cope with fear of uncertainty, and provided examples and information as to how they can expose themselves to uncertainty.
15830595|NCT04199884|Behavioral|Health-focused Psychoeducation Intervention|This intervention is a health-focused psychoeducation intervention wherein participants learn ways to engage in healthy behaviors, such as getting adequate sleep, eating healthier, and exercising regularly.
15830596|NCT04199871|Other|dichoptic 3D movies|dichoptic movies presented on a Nintendo 3DS
15830597|NCT04199858|Behavioral|Baseline pain stimulations|During baseline pain stimulations, a comparison block will include 6 high- and 2 moderate-pain stimulations.
15830598|NCT04199858|Behavioral|Conditioning|"During nocebo induction trials, the conditioned stimulus (i.e., a sham medical gel that can increase pain sensitivity, named TDA and contained in either a brown or a blue jar) is paired to unconditioned high-pain stimuli (nocebo trials). Lower 'baseline' pain is paired with no gel application (control trials)."
15830599|NCT04199858|Behavioral|Evocation|"During nocebo evocation, lower pain stimulations are administered both after the administration of the conditioned stimulus (i.e., a sham medical gel TDA) and the control stimulus (no medical gel), in order to evoke nocebo responses to the sham hyperalgesic medication."
15830600|NCT04199858|Other|Electroencephalography (EEG)|In the single group of participants, EEG recordings will be conducted during baseline, during a first resting-state of 5-minutes, during induction/evocation of nocebo responses, and during a second resting-state of 5-minutes.
15830601|NCT04199845|Dietary Supplement|PS128|PS128 or placebo will be given twice daily for 8 weeks.
15830602|NCT04199832|Dietary Supplement|Dietary guidance|Dietary guidance for feeding tube patients with food homogenate，dietary guidance for patients with oral feeding.
15830603|NCT04199819|Drug|entecavir|Patients with evidence of OBI, as characterized by any one positive biomarker (serum HBV DNA, serum HBV RNA, serum HBcrAg, intrahepatic HBV DNA, intrahepatic cccDNA) in either the donor or recipient, will be commenced on life-long oral nucleos(t)ide analog therapy as part of their routine antiviral prophylaxis.
15830604|NCT04199806|Other|Questionnaire review|Review data from questionnaires received about MMS experience.
15830605|NCT04199793|Device|Lavare On|"For the patients randomized to Lavare On group, the Lavare™ cycle will be turned on upon device interrogation after patients return to intensive care unit from the operating room."
15830606|NCT04199793|Device|Lavare Off|"For the patients randomized to Lavare Off group, the Lavare™ cycle will be turned off upon device interrogation after patients return to intensive care unit from the operating room."
15830649|NCT04199468|Drug|Active Ketamine|Active Ketamine (0.2 mg/kg) given intravenously (IV)
15830650|NCT04199468|Drug|Placebo Ketamine|A placebo dose given intravenously (IV)
15830607|NCT04199780|Device|Transcranial Direct Current Stimulation|Transcranial direct current stimulation (tDCS), stimulates specific areas of the brain via electric current passed through electrodes placed on the scalp. During tDCS, low amplitude direct currents penetrates the skull to enter the brain and modulates neuronal activity.
15830608|NCT04199780|Behavioral|Cognitive-Behavioral (CB) intervention|CBI generally consist of cognitive coping strategies (e.g., distraction, relabeling, reducing pain-catastrophizing) and self-management (e.g., relaxation strategies, guided imagery) designed to enhance perceived control and reduce sympathetic nervous system tone.
15830609|NCT04199767|Drug|20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly & Company)|Participants will be assigned to receive regular insulin either 20 or 40 IU administered through an intranasal nebulizer-like device.
15830610|NCT04199767|Drug|40 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly & Company)|Participants will be assigned to receive regular insulin either 40 or 20 IU administered through an intranasal nebulizer-like device.
15830611|NCT04199754|Drug|Omnipaque 300mg/mL Solution for Injection|Prior to the contrast enhanced Cone Beam CT, 100mL of Omnipaque will be administered by IV at a rate of 2mL per second, followed by administration of 50mL of 0.9% saline.
15830612|NCT04199754|Radiation|Cone Beam CT|60 seconds after contrast administration, a Cone Beam CT will be performed.
15830613|NCT04199754|Radiation|Radiation Therapy|Standard of Care Radiation Therapy will be administered, dosage depends on the type of tumor being treated.
15830614|NCT04199754|Drug|0.9% Saline|50 ML of 0.9% Saline will be administered immediately after Omnipaque administration
15830615|NCT04199741|Drug|89Zr-DFO-SC16.56|Injection of 2 mCi of 89Zr-DFO-SC16.56 for Phase I participants. Dose for Phase II will be determined by results from Phase I.
15830616|NCT04199741|Drug|SC16.56, Phase I, Cohort 2|7.5mg
15830617|NCT04199741|Drug|SC16.56, Phase I, Cohort 3|22.5mg
15830618|NCT04199741|Drug|SC16.56, Phase II|Dose for Phase II will be determined by results from Phase I.
15830619|NCT04199728|Drug|Liraglutide Pen Injector|Liraglutide will be provided using an injection pen provided by the manufacturer
15830620|NCT04199728|Drug|Placebo|Placebo injection pen
15830621|NCT04199715|Biological|Heplisav-B|This is an FDA-approved vaccine for Hepatitis B that is made by Dynavax Technologies.
15830622|NCT04199702|Other|Same day discharge|Patients will be discharged the same day they undergo catheter ablation of atrial fibrillation.
15830623|NCT04199689|Biological|9vHPV Vaccine|9-valent human papillomavirus vaccine (9vHPV) is an aluminum-adjuvanted recombinant protein vaccine prepared from the highly purified virus-like particles (VLPs) of the recombinant major capsid (L1) protein of HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 given as a 0.5 mL intramuscular injection.
15830624|NCT04199689|Other|Placebo (Saline for Injection)|0.9% sodium chloride given as a 0.5-mL intramuscular injection
15830625|NCT04199676|Diagnostic Test|Glucose tolerance test|Oral administration of a 75g glucose tolerance test during the postpartum hospitalization
15830626|NCT04199637|Other|TVG|Therapeutic video game
15830627|NCT04199624|Drug|Omeprazole 20mg|Omeprazole twice daily x 5 days
15830628|NCT04199624|Dietary Supplement|Vitamin C|Ascorbic acid x 1 on day 5
15830629|NCT04199611|Procedure|Liposuction|This is a type of fat removal procedure used in plastic surgery.
15830630|NCT04199611|Behavioral|Cognitive Behavioral Therapy|This is a psycho-social intervention that aims to improve mental health.
15830631|NCT04199598|Drug|Abediterol (2.4 μg)|2.4 μg (delivered dose) abediterol via PARI LC SPRINT nebuliser
15830632|NCT04199598|Drug|Abediterol (4.8 μg)|4.8 μg (delivered dose) abediterol via PARI LC SPRINT nebuliser
15830633|NCT04199598|Drug|Abediterol (2.4 μg)|2.4 μg (delivered dose) abediterol via OMRON NE-C900-E nebuliser
15830634|NCT04199598|Drug|Abediterol (2.5 μg)|2.5 μg (nominal dose) abediterol via DPI, reference
15830635|NCT04199585|Drug|Lu AF95245|solution, single dose, orally
15830636|NCT04199585|Drug|Lu AF95245 14C radiolabelled spiked dosage|solution, single dose, orally
15830637|NCT04199585|Drug|Placebo|solution, single dose, orally
15830638|NCT04199572|Drug|Diclofenac and Paracetamol|analgesic effect of diclofenac along with either Oral versus Intravenous paracetamol versus placebo
15830639|NCT04199559|Drug|Autologous dendritic cells pulsed with antigen|peptide(WT1-H/K-HELP, Survivin-H/K-HELP,MAGE-A4-H ⁄ K-HELP and MUC1-22) . Each dose contains of 10 million activated autologous DCs. Route of Administration: Intradermal
15830640|NCT04199546|Other|Chewing and swallowing rehabilitation|A home based chewing and swallowing training program (CST) will be applied by an experienced physical therapist. The Functional Chewing Training will be used to improve chewing function which has five steps including positioning the child and food, sensory stimulation, chewing training and adjustment of food consistency to improve chewing function. To support hyolaryngeal elevation, laryngeal mobilization will be performed. Hyolaryngeal mobilization will be performed by moving hyolaryngeal complex in right, left and up directions manually.
15830641|NCT04199533|Behavioral|RUBI|Parent-mediated behavioral program targeting disruptive behavior utilizing principle of applied behavior analysis
15830642|NCT04199533|Behavioral|RUBIES|School-staff mediated behavioral program targeting disruptive behavior utilizing principle of applied behavior analysis
15830643|NCT04199520|Combination Product|surgery combined with systemic therapy|surgery combined with systemic therapy
15830644|NCT04199520|Other|systemic therapy|systemic therapy
15830645|NCT04199507|Other|physical fitness assessment|assessment
15830646|NCT04199494|Other|Antibiotic Stewardship Program|The patient do the routinely preoperative lab tests, including the rectal swab (RS). The Antibiotic Stewardship Program (ASP) has been shown to effectively reduce unnecessary antibiotic use and optimize the treatment of infectious diseases. To be successful, multiple aspects should be considered in the ASP. Initially, the infection control specialists will follow the routine activity of each department in order to define what could immediately be improved. Internal antibiotic prophylaxis and therapy guidelines will be defined and shared between groups. The RS, collected at the preoperative testing, is evaluated by the infection control specialist. In case of identification of MDR bacteria, each patient will receive a tailored AP based on the antibiograms of the RS. In any case, the infection control specialist will choose the best solution for the patient avoiding the key antibiotics
15830647|NCT04199468|Drug|Active Delta-9-THC|Active Delta-9-THC (0.015 mg/kg) given intravenously (IV)
15830651|NCT04199455|Drug|Integrative Treatment (EPACH Recipe Granules + NQABC Recipe Granules)|"Patients randomly assigned to the intervention group will receive EPACH and NQABC Chinese herbal compound granules, which will be manufactured by the Beijing Kangrentang Pharmaceutical company, combined with standard stroke care according to the Guidelines for the diagnosis and treatment of acute ischemic stroke in China 2018.
~Route of administration: oral.
~Dose regimen:
~Day 1 to Day 5: in addition to the guideline-based standard treatment, 7.35g of EPACH recipe granules, dissolved with 200ml of boiled water, twice a day.
~Day 6 to Day 15: in addition to the guideline-based standard treatment, 6.85g of NQABC recipe granules, dissolved with 200ml of boiled water, twice a day."
15830652|NCT04199455|Drug|Placebo|"Patients randomly assigned to the intervention group will receive recipe simulators as placebo. EPACH and NQABC granules and recipe simulators are indistinguishable, identical in size, shape, color, appearance. Placebo is no decocting granules contain 5% original formula, 20% bitter gourd extract, 75% dextrin, and caramel color. Those who are assigned to the control group will be given placebo and guideline-based standard stroke treatment.
~Route of administration: oral.
~Dose regimen:
~Day 1 to Day 5: in addition to the guideline-based standard treatment, 7.35g of recipe simulator, dissolved with 200ml of boiled water, twice a day.
~Day 6 to Day 15: in addition to the guideline-based standard treatment, 6.85g of recipe simulator, dissolved with 200ml of boiled water, twice a day."
15830653|NCT04199429|Behavioral|Relationship-Based Care|
15830654|NCT04199416|Device|mRehab app|The mRehab app will be an interactive system with a user-friendly graphical user interface to provide multiple motivational functions that engage individuals in their prescribed home exercises. The app will contain video-based lower limb strengthening and aerobic exercise materials, health information, and motivational functions to increase their access to rehabilitation and care resources to augment their self-management ability.
15830655|NCT04199416|Device|Sham app|The sham app will only contain educational components and text-based exercise recommendations.
15830656|NCT04199390|Procedure|total hip arthroplasty|each patient is expected to undergo an anterior total hip arthroplasty procedure and some sort of physical therapy postoperatively
15830657|NCT04199377|Procedure|HIP KNEE REPLACEMENT|HIP KNEE REPLACEMENT
15830658|NCT04199364|Drug|Poractant Alfa 80 mg/mL Intratracheal Suspension|Exogenous surfactant (Poractant Alfa) administration at a dose of 200 mg/kg.
15830659|NCT04199351|Drug|AMG 171|2 SAD cohorts of 8 subjects per cohort randomized 3:1 in Part A; 1 cohort of 8 subjects 3:1 ratio in Part B; and 24 subjects enrolled into 1 of 3 cohorts with 8 subjects randomized to receive 2 to 3 consecutive doses (titration) 3:1 ratio in Part C.
15830660|NCT04199351|Drug|Placebo|AMG 171 placebo
15830661|NCT04199338|Other|The Effect of Web Based Education Based on Self-Care Deficiency Theory on Self-Care Power and Self-Efficacy and Perceived Social Support in Patients Receiving Peritoneal Dialysis|"In the study, which will last for 3 months, the patients in the intervention group will receive pre-test Web-based training based on the Self-Care Deficiency Theory. And an intervention group will be expected to use the website weekly. Also weekly reminder messages will be sent regularly.
~Following the final test, individuals in the enterprise group will be asked to evaluate their views on the website in writing with the WAMMI test."
15830662|NCT04199325|Dietary Supplement|Probiotics|Patients will be randomly assigned to the routine treatment + placebo group and probiotics + routine treatment group according to 1:2 ratio.
15830663|NCT04199325|Drug|uric-acid-lowering drug|Patients will be randomly assigned to the routine treatment + placebo group and probiotics + routine treatment group according to 1:2 ratio.
15830664|NCT04199312|Device|The ZELTIQ System|The MMS device will be used to perform the treatments.
15830665|NCT04199299|Device|Heart rate and respiration rate sensors|The use of sensors to monitor physiological variables (e.g. heart rate, sleep). The design is a before-and-after comparison with respect to whether the use of sensors has changed the caregivers' practice and their (perceived) understanding of the participant. The frequency of participants' self harm or aggressive behavior after as compared to before the introduction of pulse- and respiration monitors will also be charted.
15830666|NCT04199286|Procedure|symmetrical and asymmetrical horizontal strabismus surgery|surgery was done on the medial rectus muscle on both eyes, lateral rectus muscle in both eyes or medial and lateral rectus muscle in one eye
15830667|NCT04199273|Procedure|Magnetic stimulation|Cervical bilateral phrenic nerve stimulation with the MagStim 200 tool.
15830668|NCT04199273|Procedure|Electric stimulation|Cervical bilateral phrenic nerve stimulation after ultrasonography nerve tracking and targeted electric stimulation with a nerve stimulator usually used for neuromuscular transmission monitoring (TOFScan, Drager)
15830669|NCT04199260|Device|papilocare vaginal gel|Papilocare is a gel vaginally administered by a single-dose cannula. Vaginal gel formulation is effective as a local treatment with controlled systemic absorption and rapid and efficient distribution
15830670|NCT04199247|Behavioral|Sub symptom aerobic exercise|Participants will meet with a member of the research team to undergo a bike-based exercise test at the initial test. Heart rate will be obtained at the completion of the test, and intervention participants will be asked to complete exercise at 80% of that level, 5x/week for 20-30 minutes/session over the next two months.
15830671|NCT04199234|Dietary Supplement|Experimental product consumption|Consumption of an encapsulated iron supplement, 60 mg iron per day over 14 days, 2 hours before lunch
15830672|NCT04199234|Dietary Supplement|Comparator product consumption (Iron sulphate)|Consumption of iron supplement, 60 mg iron per day over 14 days, 2 hours before lunch
15830673|NCT04199221|Behavioral|Stress Innoculation Training (SIT)|1 hour lecture that will cover the conceptualization phase and skills-training phase portions of stress inoculation training.
15830674|NCT04199221|Behavioral|Extra attempt|an extra attempt at intubating a mannequin configured at a difficulty level higher than will be used in the future scenarios
15830675|NCT04199208|Other|Prehabilitation and Immunonutrition|See study synopsis
15830676|NCT04199208|Other|Standard Care Arm|Standard care as per the daily routines of the Hospital at which the study takes place
15830677|NCT04199182|Behavioral|Exercise Training|A multi-component group exercise intervention that emphasizes functional training. Duration is 6 months, and frequency is 3x per week.
15830701|NCT04199065|Other|Good Practice Guidelines implementation|Implementation of Good Practice Guidelines on the framework of the Best Practice Spotlight Organization in Spain (CCEC® / BPSO®), that allows a standardized methodology for providing care and registering indicators.
15830678|NCT04199182|Other|Healthy Aging Attention Control (HA-ATC)|"Participants in the HA-ATC group will receive a health education program modeled on the 10 Keys to Healthy Aging curriculum and the National Council on Aging's Aging Mastery Program. HA-ATC will include an 8-week face-to-face group program followed by bi-weekly sessions for the remaining 4 months."
15830679|NCT04199169|Biological|HeV-sG-V|A Hendra virus soluble glycoprotein vaccine formulated in phosphate buffer and adjuvanted with aluminum hydroxide. Placebo is normal saline.
15830680|NCT04199169|Biological|Normal Saline Placebo|0.9% Saline
15830681|NCT04199143|Drug|Nitrous Oxide-Oxygen|The medical product used in this study is a gas for common medical use in various domains including anesthesic, consisting in the equimolar mixture of nitrous oxide and oxygen. Subjects will receive a mixture of 50% N2O / 50% O2 for 1 hour.
15830682|NCT04199143|Device|Tissue Pulsatility Imaging - TPI|Tissue Pulsatility Imaging (TPI) is a variation of ultrasonic Doppler strain imaging we are developing to measure the local expansion and relaxation of the brain tissue over the cardiac cycle to characterize and image perfusion.
15830683|NCT04199143|Device|Magnetic Resonance Imaging - MRI|Structural and Functionnal (including BOLD and ASL) MRI will be aquired in this study
15830684|NCT04199130|Behavioral|BrainHQ|"BrainHQ is a web-based brain-training program. The investigators will assign participants to attention specific modules that they will complete at home with the goal of restoring attentional functions lost through injury via repetitive tasks of graded difficulty."
15830685|NCT04199130|Behavioral|Goal Management Training|"This is a manualized, interactive, metacognitive-strategy training designed to promote a mindful approach to complex real-life tasks and reduce lapses in attention via implementation of compensatory mechanisms for monitoring tasks."
15830686|NCT04199117|Drug|Varenicline|Participants randomized to intensive treatment who choose to use this intervention will receive one 0.5 mg pill for the first 3 days, starting 7 days prior to the target quit day (TQD). They will then use one 0.5 mg pill twice daily for the next 4 days. After the first week of study medication ramp up, participants will use one 1 mg pill twice daily until 11 weeks post-TQD. This will not be used at the same time as combination nicotine replacement therapy.
15830687|NCT04199117|Drug|Combination nicotine patch and nicotine mini-lozenge treatment|Participants randomized to intensive treatment who choose to use this intervention will receive 12 weeks of nicotine patches and nicotine mini-lozenges starting on the target quit day (TQD). Participants who smoke more than 10 cigarettes/day will start with a 21 mg patch for 8 weeks, and then titrate down to a 14 mg patch for 2 weeks and then a 7 mg patch for 2 weeks. Participants who smoke 5-10 cigarettes/day will be given 10 weeks of 14 mg patches and then 2 weeks of 7 mg patches. Participants will receive 2 mg mini-lozenges for use starting on the target quit date and the following 12 weeks. Participants will be instructed to use 9-20 mini-lozenges per day (one every 1-2 hours) for the first 6 weeks, then reduce to a mini-lozenge every 2-4 hours for 3 weeks, and then a mini-lozenge every 4-8 hours for 3 weeks. Combination nicotine patch and nicotine mini-lozenge treatment will not be used at the same time as varenicline.
15830688|NCT04199117|Behavioral|Monetary incentives for initiating treatment|Participants randomized to this intervention will earn a $40 incentive each time they complete a first counseling session in an available treatment, up to 2 rounds of counseling per year, and up to 4 rounds of counseling over 2 years of enrollment.
15830689|NCT04199117|Behavioral|Automated tailored outreach|Participants randomized to this intervention will receive 5 tailored letters delivered every 4-6 months. Letter content will be tailored to participant demographics and use of study treatment, and personalized with references to their primary care teams and tobacco care manager. Letters offer encouragement to quit and information about how to access available treatments.
15830690|NCT04199117|Behavioral|Care management|Participants randomized to this intervention will receive 5 live, proactive phone calls lasting 10-15 minutes from as assigned Tobacco Care Manager who will provide manualized support and motivational encouragement, discuss available treatment options, and inform the participant how to initiate treatment when ready to quit.
15830691|NCT04199117|Other|Wisconsin Tobacco Quit Line referral|This is recommended standard care that will be offered to participants who are not medically eligible for varenicline or combination nicotine patch or who are randomized to standard treatment access. The Wisconsin Tobacco Quit Line (WTQL) offers a single 20-minute counseling session to all Wisconsin residents ready to set a date to stop smoking in the next month, at no charge, and offers those who meet their medical eligibility criteria a 2-week supply of either nicotine patches, lozenges, or gums, at no charge. The WTQL assumes full clinical responsibility for participants' use of cessation medications dispensed by the WTQL.
15830692|NCT04199117|Other|Primary care provider referral|This is a form of recommended standard care that will be offered to participants who are not medically eligible for varenicline or combination nicotine patch or who are randomized to standard treatment access. Participants who choose to use this intervention will be referred electronically to their primary care provider for counseling and/or medication if they express an interest in quitting in the next 30 days and agree to this referral.
15830693|NCT04199117|Behavioral|Untailored outreach|Participants randomized to this intervention will receive 5 untailored letters delivered every 4-6 months. Letter content will not be tailored or personalized. Letters will offer information about how to access available treatments.
15830694|NCT04199117|Behavioral|Multiple smoking cessation coaching calls|Participants randomized to intensive treatment access who choose to quit will receive three 15-20-minute quit coaching calls from a trained smoking cessation health counselor. Calls will be scheduled for one week pre-quit, one day after the target quit day, and one week after the target quit day.
15830698|NCT04199091|Procedure|Craniosacral Therapy (CST) self-help techniques|Manual self-help techniques based on Craniosacral Therapy (group setting).
15830699|NCT04199091|Procedure|Progressive Muscle Relaxation (PMR)|Progressive muscle relaxation according to Jacobsen (group setting).
15830700|NCT04199078|Device|Papilocare vaginal gel|Papilocare is a gel vaginally administered by a singledose cannula. Vaginal gel formulation is effective as a local treatment with controlled systemic absorption and rapid and efficient distribution
15831078|NCT04195945|Drug|Cytarabine|Given IV
15830703|NCT04199039|Other|Effect on Endotracheal Tube Fixation Methods on Hemodynamic Parameters During Endotracheal Suction|"When the study started, the first 43 patients were assigned to the control group and the following 43 patients were assigned to the study group in the CVS ICU. ET fixation in the control group was performed with plasters, which are routinely used in the ICU where the study was conducted. ET fixation of the patients in the study group was performed with an ET holder (AnchorFast Oral Endotracheal Tube Fastener, Hollister, Liberlyville, USA) when they arrived at the CVS ICU.
~The patients' SBP, DBP, HR and SpO2 values, which were displayed on the bedside monitor (Nihon Kohden, Tokyo), were recorded on the Hemodynamic Parameters Form just before, during, and at the end of endotracheal suction, and in the following 5th and 15th minutes."
15830704|NCT04199026|Drug|Doxorubicin|Given via microdevice
15830705|NCT04199026|Drug|Doxorubicin Hydrochloride|Given via microdevice
15830706|NCT04199026|Device|Drug Delivery Microdevice|Undergo percutaneous implantation of drug delivery microdevice
15830707|NCT04199026|Drug|Everolimus|Given via microdevice
15830708|NCT04199026|Biological|Ganitumab|Given via microdevice
15830709|NCT04199026|Drug|Ifosfamide|Given via microdevice
15830710|NCT04199026|Drug|Irinotecan|Given via microdevice
15830711|NCT04199026|Drug|Pazopanib|Given via microdevice
15830712|NCT04199026|Drug|Polyethylene Glycol|Given via microdevice
15830713|NCT04199026|Drug|Temozolomide|Given via microdevice
15830714|NCT04199026|Drug|Temsirolimus|Given via microdevice
15830715|NCT04199026|Procedure|Therapeutic Conventional Surgery|Undergo standard of care surgery
15830716|NCT04199026|Drug|Vincristine|Given via microdevice
15830717|NCT04199013|Drug|Ropivacaine 0.75% Injectable Solution|Patients in Group R will receive subarachnoid injection of 2.5 ml of 0.75% isobaric ropivacaine (18.75 mg) and 0.5 ml normal saline while patients in Group RF will receive subarachnoid injection of 2.5 ml 0.75% of isobaric ropivacaine (18.75 mg) and 0.5 ml fentanyl (25 μg).
15830718|NCT04199013|Drug|Fentanyl Citrate|Patients in Group R will receive subarachnoid injection of 2.5 ml of 0.75% isobaric ropivacaine (18.75 mg) and 0.5 ml normal saline while patients in Group RF will receive subarachnoid injection of 2.5 ml 0.75% of isobaric ropivacaine (18.75 mg) and 0.5 ml fentanyl (25 μg).
15830719|NCT04198974|Behavioral|PreVenture Training (PTtT)|"PreVenture TtT model will involve identifying local expert trainers to be trained to train school-based professionals on the PreVenture program. Steps include:
~PreVenture Facilitator certification: Trainers participate in training workshops and deliver the program to eligible youth in Cohort 1 and are rated on quality of implementation using the PIFA.
~Reliable use of the PIFA: Each trainer demonstrates convergence with the Montreal Team's ratings on a set of previously-recorded PreVenture sessions.
~PreVenture Training Workshop Certification: Trainers participate in a one-day TtT workshop to review the main aims and exercises of PreVenture Training. Trainers then record mock TtT sessions in which key components of the PreVenture Training Workshop are delivered to an audience of 4-10 individuals (e.g., class of graduate students). These sessions are rated by the Montreal Team the PreVenture Implementation Fidelity and Adherence-Trainer Scale (PIFA-T)."
15830720|NCT04198974|Behavioral|PreVenture Training+Implementation Facilitation|"PreVenture TtT model + Implementation Facilitation Package:
~Youth advisors identified the role of older youth to support program implementation. Youth will help promote PreVenture to students and families and help Facilitators optimize attendance at sessions.
~Trainer-led coaching sessions will focus on enhancing program fidelity and acceptability by Facilitators. 'Best practice' supervision elements from efficacy trials will be integrated. Fidelity and symptom monitoring will be conducted in real-time during program implementation.
~Performance metrics have been developed based on youth qualitative feedback to PreVenture sessions in previous trials. Analysis indicates key responses that are predictive of students most likely to benefit from PreVenture on 12-month substance use outcomes and indicates the extent to which Facilitator's interventions are leaving students with impressions consistent with positive long-term outcomes."
15830721|NCT04198961|Other|opioid prescribing|Individualized taper and safety recommendations will be communicated to prescribers via an electronic medical record encrypted message.
15830722|NCT04198948|Drug|Omeprazole|Omeprazole (20 mg) will be administered orally once daily for 5 days in one of the two treatment periods.
15830723|NCT04198948|Drug|Placebo oral tablet|Placebo will be administered orally once daily for 5 days in one of the two treatment periods.
15830724|NCT04198948|Drug|Gliclazide|Gliclazide (40 mg) will be administered orally once, concomitantly with omeprazole or placebo on day 5.
15830725|NCT04198935|Device|Span Health Mobile Application|A 12 week structured diabetes education program for type 2 diabetes delivered through a mobile application. The application also allows for interaction with a registered nutritionist via text messaging.
15830728|NCT04198909|Diagnostic Test|Electrocochleography, electrophysiology thet for analyse the wave I generated by the auditory pathways|Electrocochleography is a technique that analyses the functionality of inner ear.
15830729|NCT04198896|Other|incidece of cancers|With a continuous surveillance system to track all subsequent incidents of cardiovascular diseases and/or non-cardiovascular diseases via direct contact in the outpatient department, hospital records, and a mailed questionnaire at least once a year, an incidence of cancers was identified
15830730|NCT04198883|Combination Product|Protheracytes|Intramyocardiac (LV) injection of stem cells with a dedicated catheter
15830731|NCT04198870|Device|MitraClip™ device implantation|Transcatheter repair of the mitral valve using MitraClip™ device
15830732|NCT04198870|Procedure|Mitral Valve Repair Surgery|Surgical repair of the mitral valve
15830815|NCT04198129|Drug|Antibiotic treatment (Unasyn or Cleocin)|Trial groups will receive a single post-operative dose administration of Unasyn 3g or Clindamycin 600mg (for penicillin allergies)
15830733|NCT04198857|Behavioral|Develop a mobile app that supports self- management and treatment for Nepalese GDM patients|We will use a user-centered design approach to develop a mobile app for GDM (mGDM) that matches the needs and technological sophistication of the target users. The goal of the app would be to assist patients in self management of GDM by improving their adherence to the recommended diet and physical activity regimens. The app will be used to collect information such as the carbohydrate consumption, the daily activity status and blood glucose and blood pressure measurements taken at home by the patients. The app will be set up in the phone of the participants and their data will be collected. The participants will be able to assess the usability and feasibility of the app. The app will also help clinicians by generating easily digestible visual displays of patient data and behaviors, which can aid in their clinical decision-making and counseling.
15830734|NCT04198844|Drug|warfarin|warfarin user
15830735|NCT04198844|Drug|apixaban|apixaban user
15830736|NCT04198831|Other|acupuncture|Patients receiving acupuncture and mild moxibustion, whom were treated 3 times per week for 12 weeks and followed up for 36 weeks. CV12 and Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and bilateral ST25 and ST36 were selected for moxibustion. Hwato acupuncture device was used to blind the subjects, and had the deqi sensation. The surface temperature of acupoints was maintained at 43℃± 1℃ for moxibustion.
15830737|NCT04198831|Other|Sham acupuncture|Patients receiving sham acupuncture and sham mild moxibustion, whom were treated 3 times per week for 12 weeks and followed up for 36 weeks. CV12 and Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and bilateral ST25 and ST36 were selected for moxibustion. Same Hwato acupuncture device was used to blind the subjects, but do not puncturing into the skin and do not have the deqi sensation. The surface temperature of acupoints was maintained at 37℃± 1℃ for moxibustion.
15830738|NCT04198818|Drug|HH2710|25mg; 50mg; 100mg; 200mg; 300mg; 400mg; 500mgBID (Decided by SMC according to the safety and PK data)
15830739|NCT04198805|Dietary Supplement|Vitamin E [(all-rac)-α-tocopheryl acetate]|Vitamin E (1000 mg) once daily for 6 months (1 capsule) and matching placebos (2 matched capsules) for 6 months
15830740|NCT04198805|Dietary Supplement|Omega-3 fatty acid (DHA EE)|DHA EE (1.89 g) once daily for 6 months (2 capsules) and matching placebo for DHA EE (1 matched capsule for 6 months)
15830741|NCT04198805|Combination Product|Omega-3 fatty acid (DHA EE) & Vitamin E [(all-rac)-α-tocopheryl acetate]|DHA EE (1.89 g) once daily for 6 months and Vitamin E (1000 mg) once daily for 6 months
15830742|NCT04198805|Other|Placebo|Matching soybean placebo (3 capsules) of all arms daily for 6 months.
15830743|NCT04198792|Other|No intervention|No intervention, but ECPR patients will be compared to ECMO-patients that have not had cardiac arrest
15830744|NCT04198779|Device|APPLI|The support with the digital application is including a 10-minutes training about the use of the digital application at the beginning of the study. Patient will have to register information about their Heart failure disease (weight, shortness of breath, fatigue, mood, cardiologist appointments, blood results, ...). During each routine consultation, patients will be encouraged to use the digital app, and the obstacles encountered will be explored and resolved. In addition, participants will receive an email containing relevant information and, every three months, an email reminder of the use of the application.
15830745|NCT04198766|Drug|INBRX-106 - Hexavalent OX40 agonist antibody|The active ingredient of INBRX-106 is a recombinant, humanized, hexavalent IgG antibody that targets the human OX40 receptor (TNFRSF4).
15830746|NCT04198766|Drug|Pembrolizumab|Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.
15830747|NCT04198753|Diagnostic Test|Skin tape stripping|Adhesive skin sampling discs will be firmly pressed against the skin in a hairless location (not the face) followed by lifting it free of the skin. Tape stripping will be collected from non-lesional skin up to 30 times. These discs will then be used to evaluate proteins and lipids. With every 5 tape strips collected, transepidermal water loss measurements will be performed.
15830748|NCT04198753|Device|Skin barrier assessment|A small device will be used to measure transepidermal water loss (TEWL), which is the quantity of water that passes from inside the body through the skin to the surrounding atmosphere via diffusion and evaporation process. The device, a probe, is simply placed against the skin surface making superficial contact and kept there for a few seconds until the measurement terminates. This will be performed at baseline and after every 5 tape strips.
15830749|NCT04198753|Diagnostic Test|Blood draw|Subjects will undergo genetic testing of FLG mutation status (5mL of whole blood in lavender top tube) and vitamin D level (2mL of whole blood in red top tube) via blood draw.
15830750|NCT04198740|Diagnostic Test|Tear sample collection via Schirmer strip and subsequent analysis by mass spectrometry|During regular consultations at the ophthalmology department of the CHUM, eligible patients will undergo a standard 5 minute Schirmer tear test. The Schirmer strips will serve as tear samples and will be sent to UQAM's Department of chemistry for mass spectrometry analysis.
15830751|NCT04198727|Other|DPD activity assessment|Phenotyping DPD with enzyme activity measure and uracil dosage
15830752|NCT04198727|Drug|Capecitabine|Capecitabine assignement at 1000mg per square meter twice daily, cycle of 21 days, 14 days of intake, 7 days of
15830753|NCT04198714|Procedure|Pudendal block|Administration of a pudendal block at the conclusion of vaginal surgery.
15830754|NCT04198701|Device|Medtronic PulseSelect Pulsed Field Ablation (PFA) System|Adult subjects with a history of drug refractory recurrent symptomatic atrial fibrillation (AF) will undergo ablation of pulmonary veins and confirmation of entrance block and, where assessable, exit block with the PulseSelect PFA System.
15830755|NCT04198688|Behavioral|Intensive Smoking Cessation Intervention|The intervention comprises 5-6 meetings during six weeks, and can be held in group or as an individual intervention. It is based on counselling and a clearly structured manual-based patient education programme taught by specially trained staff, and contains individual counselling on nicotine replacement therapy or other medical support, according to the level of dependence measured by the Fagerström test score. The first two weeks cover teaching sessions on: ambivalence and motivation, pros and cons of continuous smoking versus cessation, and a quit date is set between the 2. and 3. week. The last 3 sessions cover: risk situations, withdrawal symptoms and medical support for withdrawal symptoms, relapse prevention and how to handle a completely smoke-free life.
15830816|NCT04198129|Drug|Antibiotic treatment (Augmentin or Cleocin)|the patients in the trial group will be switched to oral Augmentin 875mg twice a day for 7 days, or oral Clindamycin 150mg to 300mg four times a day for 7 days (for penicillin allergies).
15830756|NCT04198675|Behavioral|Supervised EMG Biofeedback Exercise Training Group|Posture training and ergonomic arrangements in the workplace. EMG biofeedback training will be carried out with electromyography-controlled video game combined with PNF exercises. Each game sessions comprising the work-rest cycle covers performing the upper trapezius muscle contraction simultaneously the upper extremity PNF patterns.
15830757|NCT04198675|Behavioral|Home-Based Exercise Training Group|Posture training and ergonomic arrangements in the workplace. Posture correction exercises, contains strengthening, stretching, mobility and relaxation exercises, will be given as a home exercises program. Exercise diary and weekly calls will be use to maintain the exercise adherence
15830758|NCT04198675|Behavioral|Posture Training/Ergonomic Regulations Group|Posture training and ergonomic arrangements in the workplace.
15830759|NCT04198662|Device|Cryoneurolysis with a Painblocker (Epimed International, Farmers Branch, Texas)|The application of exceptionally low temperatures to reversibly ablate peripheral nerves, resulting in Wallerian degeneration with nerve regrowth at approximately 1-2 mm/day.
15830760|NCT04198662|Drug|Intercostal nerve block ropivacaine with epinephrine|3 mL of ropivacaine 0.5% (with epinephrine) will be injected perineurally to provide the intercostal nerve block(s)
15830761|NCT04198649|Drug|Non-surgical periodontal treatment and azithromycin treatment|Procedure: periodontal treatment: oral hygiene instruction, scaling and root planning Drug: two 250mg azithromycin tablets one time daily for 3 days after scaling and root planning sessions
15830762|NCT04198649|Other|Non-surgical periodontal treatment and placebo treatment|Procedure: periodontal treatment: oral hygiene instruction, scaling and root planning Placebo: two 250mg starch tablets one time daily for 3 days after scaling and root planning sessions
15830763|NCT04198636|Drug|LY01011|LY01011 injection (120mg) by subcutaneous injection once on the first day subcutaneous injection of 120 mg (1.7 ml)only once
15830764|NCT04198636|Drug|Xgeva 120 MG in 1.7 ML Injection|Xgeva® injection (120mg) by subcutaneous injection once on the first day subcutaneous injection of 120 mg (1.7 ml)only once
15830765|NCT04198623|Drug|Montelukast 10 Mg Oral Tablet|Montelukast(Singulair) 10mg to be taken at least 2 hours prior to initiation of monoclonal antibody infusion addition to institutional protocol premedication regiment
15830766|NCT04198610|Procedure|Non surgical periodontal therapy|Procedure/Surgery: non surgical periodontal therapy and root planing (SRP) was performed in two to four appointments lasting approximately 60 minutes each under local anaesthesia (2% lignocaine hydrochloride with 1:2,00,000 adrenaline) using area specific Gracey periodontal curettes and an ultrasonic device. The treatment was concluded in 3 months. Within the duration of the study, all subjects received supportive therapy, which included professional plaque control and reinstruction of oral hygiene.
15830767|NCT04198597|Behavioral|Unified Protocol for Transdiagnostic Treatment of Emotional Disorders|Please see arm/group descriptions
15830768|NCT04198597|Behavioral|Process-based Cognitive Behavioral Therapy|Please see arm/group descriptions
15830769|NCT04198584|Behavioral|VC-CBCS|A 14 module stress management and lifestyle group-based intervention delivered via videoconferencing Webex technology to patients who have had chronic hepatitis C and experience symptoms, stress or lifestyle requirements to promote liver health.
15830770|NCT04198571|Drug|Zinforo (ceftaroline fosamil)|IV Solution
15830773|NCT04198532|Other|Contrast bath|Contrast bath (hot and cold therapy)
15830774|NCT04198519|Other|Weight Loss|The total energy value (TEV) of the diet prescribed for each study participant will be determined by subtracting 800 kcal / day from the total daily energy expenditure, which will be based on Dietary Reference Intake (DRI) recommendations. The distribution of macronutrients will be as follows: protein 15 to 20% of TEV, lipids 25 to 30% of TEV and carbohydrates 50 to 60% of TEV.
15830775|NCT04198506|Other|Tailored tacrolimus dosing|Tacrolimus doses will be adapted according to tacrolimus blood level (conventional therapeutic drug monitoring -TDM) and additionally depending on TTV viral load.
15830776|NCT04198506|Other|Conventional tacrolimus dosing|Tacrolimus doses will be adapted according to tacrolimus blood level (conventional therapeutic drug monitoring - TDM).
15830777|NCT04198493|Device|CPAP|CPAP treatment every night plus conservative treatment for OSA: sleep hygiene and dietary counseling
15830778|NCT04198493|Other|CONSERVATIVE TREATMENT for OSA|Conservative treatment for OSA: sleep hygiene and dietary counseling
15830779|NCT04198480|Drug|JMT103|2 mg/kg subcutaneously (SC) every 4 weeks with a loading dose of 2 mg/kg SC on study days 8 and 15.
15830780|NCT04198467|Biological|Platelet rich plasma|Platelet rich plasma : 100 billion platelets in 10 ml of plasma(PRP) administered intra-articular
15830781|NCT04198467|Drug|Hyaluronic Acid|Hyaluronic acid :Four ml of high-molecular-weight hyaluronic acid with a concentration of 22mg/ml injected intra-articular
15830782|NCT04198454|Other|Compression bandages|Class I (20-30 mmHg) compression bandages or stocking
15830783|NCT04198454|Other|Standard wound dressings|Wound dressings alone consisting of gauze and skin tape to cover the wound
15830784|NCT04198454|Device|Fractional ablative carbon dioxide laser|Participant will have laser applied to their wound bed.
15830785|NCT04198441|Device|Wound dressing|Clean wound, fill wound, dress wound
15830786|NCT04198428|Other|Opioid Wizard|The Opioid Wizard is an OUD clinical decision support tool for primary care providers to help assess, diagnose, and treat OUD in primary care (where appropriate).
15830787|NCT04198402|Biological|Biological sampling|Blood sample (5mL) for metabolomic dosage and Fecal sample for ARN16s sequencing
15830788|NCT04198389|Procedure|PARTIAL KNEE REPLACEMENT|PARTIAL KNEE REPLACEMENT
15830817|NCT04198129|Other|Control Group|Control group will not receive any postoperative antibiotics other than what is accepted as preoperative prophylactic antibiotics as per current standards of care
15830818|NCT04198116|Drug|Varenicline|Varenicline 2mg/day
15830819|NCT04198116|Drug|Guanfacine ER|Guanfacine Extended Release (6mg/day ER)
15830906|NCT04197375|Biological|Thermal stress and performance without a pre-cooling protocol|During a tennis match the following variables were monitored: heart rate, core temperature, skin temperature, thermal sensation and comfort, rating of perceived exertion and hydration status.
15831074|NCT04195971|Diagnostic Test|Liver CT|Liver CT with precontrast, dual arterial phase, portal venous phase, and delayed phase.
15830789|NCT04198376|Procedure|Group A The Laterally Closed Tunnel Technique with SCTG|Following the administration of local anaesthesia 2% lignocaine hydrochloride.In the LCT technique a bevelled intrasulcular incisions will be made around the necks of the affected teeth with Orban Knife.The tunnelling will be accomplished with tunneling instrument (TKN2).A mucoperiosteal tunnel will be prepared using a specially designed tunneling instrument.The muscle and collagen fibres will be released using surgical blades and gracey curettes.Subepithelial CTG will be harvested from palate using single incision technique.The graft will be removed and will be placed on saline soaked gauze and kept wet until its transfer to the recipient bed.An immediate closure of the donor site is performed using modified mattress sutures.The graft will be adapted to the CEJ by means of sling suture.Finally the margins of the pouch will be pulled together over the graft and sutured with interrupted sutures.The surgical sites will be protected with a non eugenol periodontal dressing.
15830790|NCT04198376|Procedure|Group B Modified Coronally Advanced Tunnel Technique with SCTG.|In MCAT technique all the buccal tissues will be undermined and connected only the papillary region will be left attached.A full thickness preparation of the papillary region will be created this will be done with a small elevator.A second surgical site to obtain the subepithelial CTG using single incision technique.A support suture will be performed to guide the CTG into the recipient site.The graft will be gently pushed into the pouch with a packing instrument and by pulling the support suture.The entire gingivopapillary complex will be moved coronally using a vertical mattress suture anchored in the lingual gingiva.The anchorage in the lingual gingiva will be placed far apically.The suture must capture the buccal flap and graft to avail optimal stabilization.The surgical sites will be protected with a non eugenol periodontal dressing.
15830791|NCT04198363|Drug|Vonoprazan|Vonoprazan Tablets
15830792|NCT04198363|Drug|Amoxicillin|Amoxicillin Capsules
15830793|NCT04198363|Drug|Clarithromycin|Clarithromycin Tablets
15830794|NCT04198363|Drug|Bismuth Potassium citrate|Bismuth Potassium citrate
15830795|NCT04198363|Drug|Esomeprazole|Esomeprazole Tablets
15830796|NCT04198350|Procedure|Islet implantation|Transplantation of allogeneic pancreatic human islets will be performed into the anterior chamber of a single eye with the poorest visual acuity (see inclusion/exclusion criteria below). Up to 40 000 IEQ of islets in a maximum volume of 350µl will be transplanted.
15830797|NCT04198337|Procedure|Endoscopic Full Thickness Resection|Endoscopic full thickness resection achieved by resecting the submucosal tumor using retraction techniques and submucosal dissection, followed by closure
15830798|NCT04198324|Procedure|Closure of the uterus with endometrium at the time of cesarean|Closure of the uterus at the time of primary cesarean will be performed with suturing the endometrium.
15830799|NCT04198324|Procedure|Closure of the uterus without endometrium at the time of cesarean|Closure of the uterus at the time of primary cesarean will be performed without suturing the endometrium.
15830800|NCT04198311|Behavioral|CBT-I|CBT-I will be delivered individually, in five weekly sessions. Intervention components include sleep hygiene, sleep restriction, stimulus control, relaxation, cognitive therapy.
15830801|NCT04198298|Drug|EndoSequence|The EndoSequence® retrograde sealing material was used to provide a biologic seal at the apex.
15830802|NCT04198298|Drug|ProRoot MTA|The ProRoot® MTA retrograde sealing material was used to provide a biologic seal at the apex.
15830803|NCT04198298|Drug|Biodentine|The Biodentine® retrograde sealing material was used to provide a biologic seal at the apex.
15830804|NCT04198285|Procedure|Retrograde bladder filling|The bladder will be filled with a large syringe through the urinary catheter (which is left in place for the surgery) with 200mL of sterile saline, and then the catheter will be removed.
15830805|NCT04198272|Behavioral|CyberRwanda|The CyberRwanda intervention consists of three primary components: 1. Guide to Teen Success: The CyberRwanda curriculum empowers youth to learn about FPRH and employment skills and to set goals for their futures through age-appropriate, interactive, digital and printed stories and activities. 2. Ask Mutoni / Ask Ntwali: The Q&A platform answers questions and provides referrals to local youth-friendly services through 'Mutoni' and 'Ntwali,' virtual peer educators who provide evidence-based, teen-friendly information and signposting to clinics. 3. Youth can directly purchase health products, including menstrual hygiene and contraceptive products (emergency contraception, condoms, and oral contraceptive pills) online and via SMS. The online and SMS clinic finder tool links youth clients to clinics for longer-acting methods. All participating pharmacies will be trained using the custom digital training game that supports them to give unbiased, nonjudgmental information and services.
15830806|NCT04198259|Procedure|interventional devascularization|Interventional devascularization (BRTO and its variations) is a procedure for treatment of fundal varices associated with a large gastro-/splenorenal collateral.
15830807|NCT04198259|Procedure|TIPS|TIPS is very effective in the treatment of bleeding GV, with more than a 90% success rate for initial hemostasis. It frequently requires additional embolization of spontaneous collaterals feeding the varices. The incidence of encephalopathy was higher after TIPS.
15830808|NCT04198233|Drug|Diazepam|Diazepam 10 mg compounded suppository
15830809|NCT04198233|Drug|Placebos|Placebo suppository
15830810|NCT04198194|Diagnostic Test|Predictors of events|Apple Heart & Movement Study in Apple Research app
15830811|NCT04198168|Drug|IV crystalloid fluid bolus|The participant receives IV fluid as a standardised bolus of 7 ml/kg (ideal body weight).
15830812|NCT04198155|Radiation|stereotactic body radiotherapy (SBRT)|Image-guided stereotactic body radiation therapy
15830813|NCT04198142|Behavioral|Imagery Rehearsal Therapy|"The Imagery Rehearsal Therapy (IRT) intervention used in this study is a short version of the treatment, consisting of 1-2 sessions.
~The protocol starts with a very brief explanation of the treatment. Then the patient will be guided through an imagery exercise. The next step is to choose a nightmare. This nightmare is then rescripted to a new narrative, which is in no way distressing to the patient anymore. Subsequently, the therapist will guide the patient through an imagery exercise with the new narrative. The new narrative is then either written down or recorded. Lastly, the therapist will explain to the patient, that he or she should rehearse the new narrative daily with imagery exercises."
15830814|NCT04198142|Behavioral|Treatment as Usual with dream diaries|Treatment as Usual means that patients in this arm will receive usual inpatient care. Additionally, they will keep a dream diary. It has been shown in previous studies that keeping a dream diary has a positive effect on nightmares.
15830937|NCT04197141|Radiation|Hypofractionated WPRT|Total dose: 25 Gy in 5 fractions WPRT
15830820|NCT04198103|Device|Transperineal Focal Laser Ablation (TPLA)|The intervention will take place in an ambulatory setting using EchoLaser system. The treatment consists of the trasmission of laser energy into the tissue through the percutaneous insertion of optical fiber under local anesthesia. Within each needle, an optic fiber of 300 µm will be inserted. Each ablation lasts 6 minutes and each fiber ablates 1800J at a power of 3W. At the end of the first ablation there is a pull-back of about 1 cm from the original ablation location. According to the dimension of the middle lobe of the prostate, multiple pullbacks can be used for a total duration of about 30minutes. At the end of the treatment corticosteroid is given for anti-edema and anti-inflammatory effects and Antibiotic therapy and gastroprotective therapy is given. After an adequate amount of time for observation, the patient is dismissed.
15830821|NCT04198090|Behavioral|SGM Competency Training Program|A validated, two-hour long SGM curriculum created by the Fenway Institute and tailored for oncology
15830822|NCT04198077|Drug|Oxygen|Administered via invasive or non-invasive mechanical ventilation with fraction of inspired oxygen between 0.21 and 1.0
15830823|NCT04198064|Procedure|Bag Squeeze|"Participants will receive a bag squeeze of irrigation fluid (500 ml/~2 cups of % 0.9 saline solution) during the insertion of the cystocopy tube during their cystocopy."
15830824|NCT04198064|Procedure|No Bag Squeeze|Participants will receive a standard cystocopy procedure as per standard of care.
15830825|NCT04198051|Drug|adjuvant chemotherapy|"Form、dosage and frequency： Gastric cancer was given the SOX regimen (oxaliplatin + tegafur regimen,oxaliplatin 130mg/m2 intravenous infusion, the 1st day; tegafur 80mg/ m2/d orally Bid, the 1st to 14th day, every 21 days is one cycle) or XELOX regimen (oxaliplatin + capecitabine regimen，oxaliplatin 130mg/m2 intravenous infusion, the 1st day; capecitabine 1000mg/m2/d orally Bid, the 1st to 14th day, every 21 days is one cycle).
~Colon cancer was given the XELOX regimen (the dosage、frequency and administration are the same as the gastric cancer) or FOLFOX regimen (oxaliplatin + calcium folinate + fluorouracil regimen，oxaliplatin 85mg/m2 intravenous infusion, the 1st day; calcium folinate 400 mg/m2 intravenous infusion, the 1st day; fluorouracil 400 mg/m2 intravenous infusion, the 1st day, then 1200 mg/m2/d × 2d continuous intravenous infusion，every 14 days is one cycle).
~Duration：through chemotherapy completion，about six months."
15830826|NCT04198038|Behavioral|Songwriting with licensed music therapist|Song selected by parent-child dyad with recordings of physiologic components (i.e. heartbeat, breathing)
15830828|NCT04197999|Drug|GMI-1359|Injection 10 mg/mL
15830829|NCT04197986|Drug|Infigratinib|Participants randomly assigned to infigratinib will receive hard gelatin capsules for oral administration of infigratinib 125 mg once a day (administered as one 100-mg capsule and one 25-mg capsule) using a 3 weeks on (Days 1-21) /1 week off (Days 22-28) dosing schedule.
15830830|NCT04197986|Drug|Placebo|Participants randomly assigned to placebo will receive placebo matching in appearance the investigational product (infigratinib), which will be provided as hard gelatin capsules for oral use and will be administered once daily on a 3 weeks on (Days 1-21) /1 week off (Days 22-28) dosing schedule.
15830831|NCT04197960|Procedure|Microwave ablation|Use thermal energy to destroy tumor
15830832|NCT04197960|Procedure|Surgical resection|Resect tumors
15830833|NCT04197947|Device|Neuro Omega|"A neurophysiological navigation system NeuroOmegaTM (Alpha Omega. Israel) was implemented in our group and the operation of this system for aDBS experiment is proved to be successful (Fig 9, 10). This system was proved by both FDA and tFDA. The aDBS stimulation algorithm will be integrated with NeuroOmegaTM. The aDBS stimulation control will achieve through self-developed algorithms or built-in scripting of the system. We introduce NeuroOmega system to conduct the designed aDBS experiment for its multifunction and safety. Our group has established collaboration with Department of Eelectronic Engineering in Chang Gung University (Co-PI HL Chan) and BERTEC in National Ciao Tung University (Co-PI MD Ker). Three postdoctor fellows and one senior engineer have been working on the operation of this aDBS system.
~All hardware and software problems could be sorted out in time."
15830834|NCT04197934|Drug|EGFR/EGFRvIII Inhibitor WSD0922-FU|Given PO
15830835|NCT04197934|Procedure|Therapeutic Conventional Surgery|Undergo surgical resection
15830836|NCT04197921|Device|Exablate Model 4000 Type 2.0/2.1|There are two treatment stages. In both stages, the subject will receive both the sham and active ExAblate treatment, and be evaluated for 90 days post-treatment for adverse events. During Stage 1 the subject will receive the moderate intensity Exablate LIFU procedure. During Stage2, the subject will receive the enhanced intensity ExAblate LIFU procedure. The subjects are blinded as to the order of the sham vs active treatment.
15830837|NCT04197908|Device|EUS-guided gallbladder drainage (EGBD)|As listed in the arms description
15830838|NCT04197895|Procedure|Socket preservation with APRF|Socket preservation with APRF , A-PRF membranes were implanted into the extraction socket following tooth extraction. One entire A-PRF membrane would be placed at the base of the extraction socket and another A-PRF membrane will cover the extraction site then suturing will be done .Venous blood will be collected via venipuncture of the forearm with a butterfly needle into at least 10 mL sterile glass vacuum tube. The blood sample will be immediately centrifuged at 1,300 rpm (200 x g) for 8 minutes
15830839|NCT04197895|Procedure|natural healing|after atraumatic extraction , the socket will be left for natural healing after suturing
15830840|NCT04197882|Biological|OrienX010 Combination with Toripalimab injection|OrienX010 Produced by Oriengene Biotechnology Co.,Ltd. Strength: 1.0 mL/vial. Toripalimab infusion Produced by Junshi Biosciences Co., Ltd. Strength: 240 mg/6 mL/vial; Sterile water injection dosage form; Expiry date: 24 months; Date of manufacture: Based on the date of manufacture indicated in the product package.
15830905|NCT04197375|Behavioral|Thermal stress and performance using a pre-cooling protocol|One hour before a tennis match, participants were wearing a Cooling Cap (WElkins Sideline Cooling System, SCS) for 45 minutes. During the tennis match the following variables were monitored: heart rate, core temperature, skin temperature, thermal sensation and comfort, rating of perceived exertion and hydration status.
15830841|NCT04197869|Drug|Polyethylene Glycol Powder|Polyethylene Glycol 3350 17g should be mixed in 8 ounces of fluid for administration. Polyethylene glycol is a high molecular weight, water soluble polymer which can form hydrogen bonds with water molecules. It is an osmotic laxative solution which stimulates bowel movements by increasing the amount of water absorbed in the GI tract. It decreases feces consistency and increases their volume by promoting peristalsis and evacuation. The side effects of polyethylene glycol are bloating, gas or diarrhea. The half-life of polyethylene glycol is 4-6 hours and after 18 hours the concentration declines to non-quantifiable levels.
15830842|NCT04197856|Other|Standard care encouraging family-mediated disclosure of hereditary cancer risk|At counseling, eligible at-risk relatives (who may benefit from disclosure of risk information) are listed on a specified protocol in collaboration between health care provider and the participant.
15830843|NCT04197856|Other|Offer of health-care assisted disclosure by sending direct letters to at-risk relatives|The participant is offered that the health care provider at the cancer genetic unit mail a direct letter with personalized family risk information to all at-risk relatives that participant approve contact with.
15830844|NCT04197843|Device|NaviCam (ANKON)|The NaviCam (ANKON) is a miniaturised wireless endoscope in a single use capsule. It can be remotely controlled with the patient in a magnetic console. The operator to the magnetic-driven NaviCam sits in a computer workstation and manipulates the capsule suspended in a waterfilled stomach. After careful examination of the stomach, the capsule is then allowed to passed through the pylorus into duodenum and small bowel. The patient wears harness with small bowel imaging capabilities.
15830845|NCT04197830|Procedure|Thrombectomy for stroke|Patients who have had thrombectomy for acute stroke.
15830846|NCT04197817|Drug|JS002|JS002, Subcutaneous or intravenous injection of a single dose of JS002, dose cohort according to ascending dose design
15830847|NCT04197817|Drug|Placebo|Placebo,Subcutaneous or intravenous injection of a single dose of placebo, dose cohort according to ascending dose design
15830848|NCT04197804|Other|Routine tests perform|The subjects of the Tourette group and control group are subjected to routine tests performed at Tourette Center and Extrapyramidal Diseases. Both groups are initially subjected to an evaluation that aims to identify the IQ and therefore 4 tasks are presented. The 1st (with a duration of about 2 and a half minutes) and the 2nd (with a duration of about 2 minutes) related to the motor field, the 3rd (with duration of about 1 minute) and the 4th (with duration about 3 minutes) the language field. These evaluations are in practice at the Center for Tourette patients; the tasks will be administered to both groups.
15830849|NCT04197791|Device|Neuromuscular Electrical Stimulation|Neuromuscular Electrical Stimulation(NMES) to core stabilization muscles will be applied using 8 electrodes. The application time will be 30 minutes. Treatment will be programmed for 2 days per week. The program will continue for 6 weeks.
15830850|NCT04197791|Other|Core Stabilization Exercises|Warm-up and cool-down exercises will be performed before and after core stabilization exercises. The exercise time will be 30 minutes. Treatment will be programmed for 2 days per week. The program will continue for 6 weeks.
15830851|NCT04197778|Drug|DDO-3055 tablet|DDO-3055 tablet, 2 single doses separated by 6 days.
15830852|NCT04197765|Device|accelerated Thetaburst stimulation|"We will administer 20-30 treatment sessions over the course of the study. The study technician will place the coil over the Fp2 electrode of a 10-20 International EEG system hair net, to approximate stimulation of the R-OFC). For the first three treatments, the study psychiatrist will set treatment intensity to 90% MT, and gradually increase intensity to 120% MT over 20 seconds to maximize tolerability. Subsequent treatment sessions (treatment 4 and onward) will begin, and remain, at 120% MT.
~Treatment will occur 4-5 times a day, separated by an at least 45-min interval between sessions on consecutive weekdays. We estimate all study-related treatments will be complete in 5-6 weekdays."
15830853|NCT04197765|Device|Sham Comparator|All parameters will be programmed in the same way as active treatment, however, the treatment will be delivered on the side of the coil that has an internal (hidden) metal shield that will prevent magnetic energy from reaching the skull and brain. Neither the technician, treating physician, nor the patient, will know whether the treatment was delivered from the sham or active side of the coil. The same auditory and tactile cues will be present during active and sham treatment as electrodes will be placed on the scalps of each participant (whether receiving active or sham treatment) that deliver some electrical sensation.
15830854|NCT04197752|Other|Regional anesthesia/analgesia techniques|Neuroaxial or peripheral block anesthesia/analgesia technique that is appropriate for the patient's surgery
15830855|NCT04197739|Drug|Amikacin|"Patients in the intervention arm will receive a fixed, single daily dose of amikacin, 500 mg, a day.
~Patients in the Comparator arm will receive a weight adjusted loading dose of amikacin (15 mg/kg adjusted body weight) and continue in adjusted intervals according to the Barnes Jewish Hospital nomogram"
15830856|NCT04197726|Other|sbeIIa/b white bread|one bread roll containing approximately 75 g of available carbohydrates to be consumed at breakfast
15830857|NCT04197726|Other|Control white bread|one bread roll containing approximately 75 g of available carbohydrates to be consumed at breakfast
15830860|NCT04197700|Other|Target MAP Management|Target MAP Management
15830861|NCT04197687|Biological|Multi-epitope HER2 Peptide Vaccine TPIV100|Given ID
15830862|NCT04197687|Biological|Pertuzumab|Given ID
15830863|NCT04197687|Other|Placebo Administration|Given ID
15830864|NCT04197687|Biological|Sargramostim|Given ID
15830865|NCT04197687|Biological|Trastuzumab|Given ID
15830866|NCT04197687|Biological|Trastuzumab Emtansine|Given ID
15830867|NCT04197674|Other|Dialysis modality|This is a observational cohort study, and there is no intervention for all participants. Our aim is to evaluate dialysis modality (PD and HD) on patient survival
15830868|NCT04197661|Drug|HSK3486|Intravenously infuse 0.2 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.
15830869|NCT04197661|Drug|HSK3486|Intravenously infuse 0.3 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.
15830870|NCT04197661|Drug|HSK3486|Intravenously infuse 0.4 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.
15830871|NCT04197661|Drug|HSK3486|Intravenously infuse 0.4 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.
15830872|NCT04197648|Device|Exercise group|24 week supervised exercise program (strength and cardiovascular program).
15830873|NCT04197635|Diagnostic Test|Maximal functional capacity by cardiopulmonary exercise testing|It will be done with cycle ergometer (CORTEX Metamax3B), starting with 10W of power and increasing 10W every minute. During the test, heart rate, rhythm and blood pressure will be monitored. Gas exchange data shall be evaluated every 10 seconds and the peak oxygen consumption (peak VO2) shall be considered the maximum value obtained during the last 20 seconds of exercise. The main parameters to be determined are: maximum functional capacity, peak VO2, slope of the VE/VCO2 ratio, and chronotropic incompetence variables. It will be performed by a trained cardiologist blind to study treatment at baseline and at 30 and 90 days after treatment initiation.
15830874|NCT04197635|Diagnostic Test|Echocardiography|The following parameters will be evaluated: a) diameters, volumes and left and right ventricle systolic function; b) longitudinal strain; c) parameters of diastolic function; d) systolic pulmonary arterial pressure; and e) left atrium volume. It will be performed by a trained cardiologist blind to study treatment at baseline and at 30 and 90 days after treatment initiation.
15830875|NCT04197635|Behavioral|Evaluation of quality of life health related|Assessment of the quality of life through the Minnesota Living with Heart Failure Questionnaire (MLHFQ), Spanish version. It will be completed at baseline and at 30 and 90 days after treatment initiation. The score of the questionnaire is 0 to 105 points.
15830876|NCT04197635|Diagnostic Test|Submáximal functional capacity assesment by 6 minutes walk test|). It will be performed in an area equipped for cardiopulmonary resuscitation. Subjects will be asked not to perform vigorous physical exercise in the previous 2 hours. They will be allowed to have a light meal before the test. Before the test, the vital signs will be determined in a seated position after a rest of 10 minutes. Subjects will be instructed to walk at their own pace to cover as much distance as possible in 6 minutes. It will be performed by a trained nurse blind to study treatment at baseline and at 30 and 90 days after treatment initiation.
15830877|NCT04197635|Other|Clinical evaluation|Evaluation of signs and symptoms of heart failure
15830878|NCT04197622|Drug|Hydrochlorothiazide|12,5 mg of hydrochlorothiazide (1/2 tablet of 25 mg) administered orally in a single dose.
15830879|NCT04197596|Biological|BK CTL|"Patient with refractory BK infection and a HLA Matched Related Donors: BK specific CTLs (2.5 x 104 CD3/kg) infused intravenously on day 0 and may be additionally reinfused at a minimum of every two weeks (depending on safety and efficacy) for a maximum of five total infusions (maximum 12.5 x 104 CD3/kg).
~Patients with refractory BK virus and a HLA Mismatched Related Donors: BK specific CTLs (0.5x104 CD3/kg) infused intravenously on day 0 and may additionally be reinfused at a minimum of every two weeks (depending on safety and efficacy) for a maximum of five total infusions (maximum 2.5 x 104 CD3/kg)."
15830880|NCT04197583|Device|Boston Scientific Ureteral Stents, Urinary Diversion Stent|A BSC Ureteral Stent is an implantable device that is used to restore flow of urine from the kidney to the bladder in obstructed ureters. A BSC Urinary Diversion Stent is an implantable device that is used to restore flow of urine from the kidney.
15830881|NCT04197570|Drug|Opioid Anesthetics|see arm/group description
15830882|NCT04197570|Drug|Non Opioid Analgesics|see arm/group description
15830883|NCT04197544|Procedure|endoFAVI|EndoFAVI creation to patients that require vascular access for hemodialysis.
15830884|NCT04197531|Other|Irrigation Method|Irrigation Method
15830885|NCT04197518|Diagnostic Test|neuro trax system and a neurology test.|"the neurology will check the patience before and after tonsillectomy or adenotonsillectomy usung the neurotrax system, these parameters will be measured in this system : Non verbal memory, Go no go test, stroop interference, Visual spatial processing, Staged information processing speed, catch game, problem solving."
15830886|NCT04197505|Behavioral|FLIR E95 camera|Video will be recorded during the thermal reading for later computer analysis. The following variables will be analyzed: (1) the difference between the mean temperature between the injured and healthy extremities, (2) the difference between the maximum temperatures of both the injured and healthy extremities (ΔTmax), and (3) the difference between the area covered by each isotherm in both the injured and uninjured extremities (Δpix). FLIR software tools and MATLAB software will be used for the analysis.
15830887|NCT04197492|Radiation|Hypofractionated Stereotactic Radiotherapy|Hypofractionated stereotactic radiotherapy (CyberKnife, 25Gy/5fx)
15830888|NCT04197492|Drug|Anlotinib|Anlotinib once daily (12mg/d) on days 1-14 of a 21-day cycle.
15830889|NCT04197479|Drug|Placebo|Matching tablets
15830890|NCT04197479|Drug|Resmetirom|Tablet
15830891|NCT04197466|Other|Pelvic Floor Exercise Group|The exercise program will be tailored according to the pelvic floor muscle strength, including fast and slow contractions. The number and duration of exercises will be increased according to progress..
15830892|NCT04197466|Other|Kinesio tape|Kinesio tape application will be performed by ligament technique to the sacral region.
15830893|NCT04197466|Other|Electrical stimulation|External electrical stimulation will be performed in the lying, sitting, stand up positions for 30 minutes
15830894|NCT04197440|Drug|BAM8-22 2mg/ml|20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop
15830895|NCT04197440|Drug|BAM8-22 1mg/ml|20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop
15830896|NCT04197440|Drug|BAM8-22 0.5 mg/ml|20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by a prick through the drop
15830897|NCT04197440|Drug|Placebo|20 µl of water will be applied to a previously determined area on the volar forearm followed by a prick through the drop
15830898|NCT04197440|Drug|BAM8-22 with 1 SPT|20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by 1 prick through the drop
15830899|NCT04197440|Drug|BAM8-22 with 5 SPT|20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by 5 prick through the drop
15830900|NCT04197440|Drug|BAM8-22 with 25 SPT|20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm followed by 25 prick through the drop
15830901|NCT04197440|Drug|BAM8-22 with inactivate cowhage spicules|20 µl of BAM8-22 will be applied to a previously determined area on the volar forearm using inactivate cowhage spicules
15830902|NCT04197427|Device|Experimental Oral Rinse|Experimental Oral Rinse is a proprietary formulation of GRAS ingredients
15830903|NCT04197427|Device|Placebo|Placebo formulation without the active ingredients
15830904|NCT04197388|Device|Inspiratory muscle training device|Inspiratory muscle training, 6 cycles of 30 breaths for 12 weeks.
15830907|NCT04197362|Other|Evaluation|Subjects will be asked to walk across the gait laboratory floor at their self-selected walking speed. They will complete a 3-5 minute warm up period, as it was found to produce stable estimates of kinetic parameter mean values during treadmill activity. The positions of each marker will be recorded through the motion capture system. Ground reaction force will be obtained in real time from the gait laboratory force plates as marker dimensions are recorded. For walking data, two trials of 15 seconds each will be recorded. The second trial will be a redundancy in the setting of potential significant marker dropout.
15830908|NCT04197349|Biological|ALD1910|Single Dose IV infusion
15830909|NCT04197349|Biological|Sumatriptan|Single dose subcutaneous injection
15830910|NCT04197349|Biological|ALD1910|Single dose subcutaneous injection
15830911|NCT04197336|Device|Bariatric Embolization of Arteries with imaging visible Embolics|The BEATLES study is an investigator-initiated, prospective, doubleblind, randomized, sham-controlled study that will assess the impact of bariatric embolization on the systemic levels of obesity related hormones and, as a consequence, on weight loss. The goal of this study is to help treat obesity combining a lifestyle program and a minimally invasive, angiographic (i.e., through blood vessels) approach.
15830912|NCT04197336|Other|Control Arm|Participants randomized to the control arm will follow the same screening and pre-procedure assessment, and will also take the same pre-procedure medications. The procedural team instead will follow a prescribed simulated protocol that will mimic an actual embolization procedure.
15830913|NCT04197323|Drug|Alprostadil liposomes for injection|40ug,once a day,continuous administration for 2 weeks
15830914|NCT04197310|Drug|Nivolumab|240mg, intravenously, Day 1 and 15 of a 28 day cycle
15830915|NCT04197310|Drug|Cabozantinib|40mg, orally, Daily for a 28 day cycle
15830916|NCT04197297|Diagnostic Test|CT and MRI Scans|CT and MRI scans will occur before and after radiation therapy.
15830917|NCT04197284|Device|Biofeedback, Myomed 632|"Biofeedback is a mind-body technique that involves using visual or auditory feedback to gain control over involuntary bodily functions.
~Electrical stimulation is a technique used to elicit a muscle contraction using electrical impulses."
15830918|NCT04197284|Device|device for electrical stimulation, BTL 4000 Smart|Electrical stimulation is a technique used to elicit a muscle contraction using electrical impulses. Electrodes, controlled by a unit, are placed on the skin over a predetermined area. Electrical current is then sent from the unit to the electrodes and delivered into the muscle causing a contraction.
15830919|NCT04197284|Other|kinesitherapy|isometric exercise of the quadriceps muscle
15830920|NCT04197271|Procedure|Emergency Hernia Repair|Emergency repair of hernia using method selected by treating surgeon.
15830921|NCT04197271|Other|Conservative management|Treatment of hernia without resort to surgery
15830922|NCT04197258|Other|Peer support|"The intervention studied is the psycho-social support by a peer-helper to the patients and their main informal caregiver during the return home following a stay in rehabilitation center for a stroke.
~Peer support intervention will be based on evidence, Bandura's social learning and social support theory, and the results of our ongoing study of the needs of patients and their caregivers as a result of returning home (Stroke69). It will include a meeting before the discharge and a regular follow-up for 6 months (face-to-face meetings, virtual or by phone), adapted to the needs of the patient and his caregiver, taking into account the social environment and in connection with the devices existing sanitary and social."
15830923|NCT04197245|Drug|saline injection therapy in post-acne atrophic scars|saline injection contains 0.9% isotonic sodium chloride solution
15830924|NCT04197232|Other|clinical evaluation|- In children: general clinical evaluation, birth weight, APGAR, ECG, admission to ICU, hospital admissions in perinatal age, presence of malformations; complete blood count, inflammatory index, complement, antibiotic treatment, brain ultra-sound, presence of infection, presence of sepsis, presence of necrotizing enterocolitis, growth curve, presence of recurrent infections, developmental milestones, response to vaccines, admission to hospital in the first year of life.
15830925|NCT04197219|Drug|Pembrolizumab|200 mg IV day 1 of each cycle every 21 days
15830926|NCT04197219|Drug|Axitinib|5 mg PO BID continuously
15830927|NCT04197206|Other|costotransverse block|patient controlled analgesia devices with tramadol
15830928|NCT04197180|Procedure|Hybrid Argon Plasma Coagulation|Argon Plasma Coagulation after water injection for local ablation
15830929|NCT04197167|Procedure|Hysteroscopy|Diagnostic procedure
15830930|NCT04197167|Device|Infrared Spectroscopy|This device uses spectral absorption of the tissue taken during hysteroscopy to determine immediate diagnosis of Chronic Endometritis
15830931|NCT04197154|Behavioral|Threat manipulation (control, no threat)|Before the start of conditioning, a mock skin-sensitivity test informs participants that their skin reacts to heat normally and it is safe for them to participate. A skin-sensitivity reading shows participants a scale that is in the green (no danger) zone.
15830932|NCT04197154|Behavioral|Threat manipulation|Before the start of conditioning, a mock skin-sensitivity test informs participants that their skin is very sensitive and their nerve fibers are very responsive and they may have adverse reactions to the heat-pain application. A skin-sensitivity reading shows participants a scale that is in the red (higher danger) zone.
15830933|NCT04197154|Behavioral|Conditioning of moderate pain|"During nocebo trials of the acquisition phase, conditioned stimuli (i.e., on-screen visual cues ON signaling the activation of sham electrical stimulation) are paired to unconditioned moderate-pain stimuli, to induce a negative association between the activation of electrical stimuli and an increase in pain. During control trials of the acquisition phase, the deactivation of the sham electrical stimulation (i.e., on-screen message OFF) is paired to 'baseline' pain of lower intensity."
15830934|NCT04197154|Behavioral|Conditioning of high pain|"During nocebo trials of the acquisition phase, conditioned stimuli (i.e., on-screen visual cues ON signaling the activation of sham electrical stimulation) are paired to unconditioned high-pain stimuli, to induce a negative association between the activation of electrical stimuli and an increase in pain. During control trials of the acquisition phase, the deactivation of the sham electrical stimulation (i.e., on-screen message OFF) is paired to pain of lower intensity."
15830935|NCT04197154|Behavioral|Extinction|"During extinction, the previously conditioned nocebo effects on pain are attenuated by pairing the nocebo and control visual cues (i.e., on-screen messages ON and OFF) to pain stimuli of only lower intensity."
15830936|NCT04197141|Radiation|Conventionally-fractionated WPRT|Total dose: 45 Gy in 25 fractions WPRT
15830938|NCT04197128|Device|Resorbable Collagen membrane with bone graft for augmentation|"Local anaesthesia Lignocaine and Adrenaline 1:80000 Injection (Lignox® 2% A, Indoco remedies Ltd, Mumbai) will be administered and midcrestal incison will be made and full thickness flap would be raised buccally. To obtain tension free adaptation of flap margins, the buccal flap advancement will be done using periosteal releasing incision. Implant osteotomies will be performed with sequential drilling and with standardised drills. All the subjects will receive the same implant system. (Norris medical ltd. Hatasia street, Nesher, Israel) For augmentation of deficient ridge, bovine bone graft will be place with overlying resorbable collagen membrane. Stabilisation would be achieved with internal resorbable horizontal mattress suture.
~The tension free flap margins will be adapted around the healing abutment with simple interrupted Vicryl 4.0, 3/8, reverse cutting resorbable sutures (Ethicon, Hamburg, Germany)"
15830939|NCT04197128|Device|Ribose cross linked collagen matrix for augmentation|"Local anaesthesia Lignocaine and Adrenaline 1:80000 Injection (Lignox® 2% A, Indoco remedies Ltd, Mumbai) will be administered and midcrestal incison will be made and full thickness flap would be raised buccally. To obtain tension free adaptation of flap margins, the buccal flap advancement will be done using periosteal releasing incision.
~Implant osteotomies will be performed with sequential drilling and with standardised drills. All the subjects will receive the same implant system. (Norris medical ltd. Hatasia street, Nesher, Israel) For augmentation of deficient ridge, ribose cross linked collagen matrix will be cut and adapted to the buccal wall and ridge around the buccal aspect of healing abutment. Stabilisation would be achieved with internal resorbable horizontal mattress suture.
~The tension free flap margins will be adapted around the healing abutment with simple interrupted 4.0, 3/8, reverse cutting resorbable sutures (Ethicon, Hamburg, Germany)."
15830940|NCT04197115|Drug|Vitamin C|Intravenous vitamin C (1.5 grams every 6 hours) will be administered for 4 days or until ICU discharge.
15830941|NCT04197115|Drug|Hydrocortisone|Intravenous hydrocortisone (50 mg every 6 hours) will be administered for 4 days or until ICU discharge.
15830942|NCT04197115|Drug|Complex B|Complex B ((Thiamine 100mg, Pyridoxine 5 mg and Cyanocobalamin 50 mcg) 1 tablet enteral route every 6 horas for 4 days or until ICU discharge
15830943|NCT04197102|Drug|CBD Isolate|A fixed dose of 300-mg of a hemp-derived formulation of purified 99.9% CBD isolate oil will be taken once daily for 8 weeks for participants randomized to the CBD arm.
15830944|NCT04197102|Other|CBD Broad Spectrum|A fixed dose of 300-mg of a hemp-derived formulation of purified 99.9% CBD Broad Spectrum oil will be taken once daily for 8 weeks for participants randomized to the CBD - Broad Spectrum arm.
15830945|NCT04197102|Other|Placebo oil|Placebo solution will be taken once daily for 8 weeks by participants randomized to the placebo arm.
15830946|NCT04197089|Drug|Vitamin D|First dose of 10.000 IU Vitamin D at baseline visit for all patients; stratification of treatment (10.000 or 50.000 IU Vitamin D) depending base 25(OH)Vitamin D levels. Treatment weekly during 4 weeks before scheduled cystectomy
15830947|NCT04197076|Drug|anti-PD-1 or anti-PD-L1|immunotherapy anti-PD-1 or anti-PD-L1
15830948|NCT04197076|Drug|EGFR-TKI, ALK inhibitor, ROS1 inhibitor|targeted therapy EGFR-TKI, ALK inhibitor, ROS1 inhibitor
15830949|NCT04197076|Drug|investigator decided|chemotherapy
15830950|NCT04197063|Behavioral|Sweetened beverage portion size limit|
15830951|NCT04197050|Drug|Sacubitril / Valsartan Oral Tablet|After recruiting participants and collecting the baseline information, sacubitril/valsartan group will receive sacubitril/valsartan and optimal pharmaceutical treatment (OPT). The control group will receive valsartan and OPT. A CMR scan and a post-processed imaging procedure will later be carried on in order to detect the cardiac impairment.
15830952|NCT04197037|Procedure|Evaluation of sialorrhea through questionnaires that measure daytime and nighttime sialorrhea and the impact on quality of life.|Sialorrhea will be evaluated by the Nocturnal hypersalivation rating scale (NHRS) and Drooling Severity and Frequency Scale (DSFS)
15830953|NCT04197024|Device|Exercise capacity test|Patients will be assessed by symptom-limited maximal cardiopulmonary exercise testing (CPET) following a 25W, tree-minute stage, beginning at 25W (healthy volunteers will start the test with a load of 50W). For both sexes and arms, participants will be instructed during the test to remain at the frequency between 60 to 80 rotations per minute (rpm). Heart rate (HR) will be continuously recorded using a monitor Polar H10.
15830954|NCT04197024|Device|Exercise capacity test in virtual reality|Patients will be assessed by symptom-limited maximal cardiopulmonary exercise testing (CPET) following a 25W, tree-minute stage, beginning at 25W (healthy volunteers will start the test with a load of 50W). For both sexes and arms, participants will be instructed during the test to remain at the frequency between 60 to 80 rotations per minute (rpm).Heart rate (HR) will be continuously recorded using a monitor Polar H10. VR HTC Vive Pro goggles along with VR health care (aerobic exercise) VR Cycling software will be used for stimulation throughout the duration of the test. The HTC Vive Tracker device will be also use to link images in virtual reality with the pedal speed.
15830955|NCT04197011|Device|prosthetic device|Individuals with TFA will use a combination of prosthetic devices.
15830956|NCT04196998|Drug|Entecavir|Patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day.
15830957|NCT04196998|Drug|Tenofovir Disoproxil Fumarate|Patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day.
15830958|NCT04196998|Drug|Tenofovir alafenamide|Patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day.
15830959|NCT04196985|Diagnostic Test|PET/MRI|each patient will perform PET/CT and PET/MRI scans in two different days within the interval of less than 2 weeks receiving two different FDG injections. Administered FDG activity for each PET scan will be 4 MBq/Kg up to a maximum of 400 MBq.
15830960|NCT04196985|Diagnostic Test|PET/CT|each patient will perform PET/CT and PET/MRI scans in two different days within the interval of less than 2 weeks receiving two different FDG injections. Administered FDG activity for each PET scan will be 4 MBq/Kg up to a maximum of 400 MBq.
15830961|NCT04196972|Other|Communication Intervention|Receive ECHO telementoring intervention
15830962|NCT04196972|Other|Questionnaire Administration|Ancillary studies
15830963|NCT04196972|Other|Waiting List|Placed on wait-list
15830964|NCT04196959|Dietary Supplement|TYR sphere|TYR sphere is a powdered protein substitute for patients with tyrosinaemia.
15831039|NCT04196257|Drug|BP1001-A (Liposomal Grb2 Antisense Oligonucleotide) with paclitaxel|Dose expansion of BP1001-A IV twice weekly (Maximum tolerated dose or Maximum admistered dose) plus paclitaxel IV weekly for 4 weeks (28-day cycle) for 6 cycles.
15830965|NCT04196946|Drug|25 mcg fentanyl|Before operation each patient was informed about the use of patient controlled analgesia system and visual pain scale (VPS) for pain scoring. In operating room all patient was monitored using electrocardiography (ECG), noninvasive blood pressure. Before spinal anesthesia 10-15 ml/kg intravenous serum saline infusion was started. Group I received 10 mg hyperbaric bupivacaine (2 cc) and 25 mcg fentanyl (0.5 cc).
15830966|NCT04196946|Drug|250 mcg alfentanil|Before operation each patient was informed about the use of patient controlled analgesia system and visual pain scale (VPS) for pain scoring. In operating room all patient was monitored using electrocardiography (ECG), noninvasive blood pressure. Before spinal anesthesia 10-15 ml/kg intravenous serum saline infusion was started. Group II received 10 mg hyperbaric bupivacaine (2 cc) and 250 mcg alfentanil (0.5 cc) intrathecally.
15830967|NCT04196933|Behavioral|Temporal Binding Adaptation - TBW training|The investigators will use a temporal order judgment (TOJ) with a visual (light) cue and a motion (yaw rotation, y-translation) cue. The relative timing of the motion onset and the light are varied and subjects indicate which occurred first by pressing a button after the motion ends. The TOJ task will generate a psychometric curve and the PSS (point of subjective simultaneity) and TBW (temporal binding window) are calculated. Then training focuses on SOAs (stimulus onset asynchronies) near the TBW borders (e.g., PSS +/- 0.5xTBW), starting from 50 ms outside the TBW and moving randomly towards the PSS. The goal of the training is to narrow the TBW -- training trials will be provided for 30 min and after each response the subject is told if their response was right or wrong. After training, the TOJ task is repeated to determine how the TBW has changed. Sham training will be the same as the actual training except that verbal feedback of response accuracy will not be provided.
15830968|NCT04196933|Behavioral|Temporal Binding Adaptation - PSS training|After the PSS and TBW are calculated with the standard TOJ paradigm, 100 training trials are provided where the SOA is set to [PSS - 200 ms], with the goal of shifting the PSS more negative. Then the TOJ task will be repeated but every 10 testing trials will be followed by 10 training trials (SOA = PSS - 200), and this pattern will be repeated 10 times to 100 more training trials interspersed with the Post TOJ data. Subjects will respond after all trials and testing and training will not be distinguished. After this is completed, the new PSS and TBW are calculated. Sham PSS training will be identical to the above except that the 'training' period will consist of random SOAs rather than a series of fixed SOAs.
15830969|NCT04196933|Behavioral|Temporal Binding Adaptation - PSS adaptation with VI stimulation|The adaptation will utilize the same approach used in non-implanted patients. The investigators will provide a repeated, fixed SOA with either the CI or VI leading the other stimulus by 220 ms. After the training period, which will match the number of stimuli pairs provided to our normal vestibular-auditory control subjects undergoing PSS adaptation, the TOJ study is repeated to recalculate the PSS and TBW.
15830970|NCT04196933|Behavioral|Chronic Motion-modulated Stimulation|To provide 8 hours of 'physiologic' CI and VI inputs during normal activities, the investigators will employ standard motion-modulated stimulation with the VI. This requires pre-adaptation to a 200 pps tonic stimulation rate (to emulate the push-pull design of the native vestibular system allowing modulating stimulation upward or downward with opposite directions of motion). The three electrodes are connected to the head-mounted prosthetic circuit, which consists of three angular velocity sensors (one aligned with the sensitive axis of each canal) such that head rotations in the plane of the given canal modulate the stimulation rate of the corresponding electrode, upward (for ipsi) or downward (for contralateral) head rotations, thereby simulating normal canal-mediated modulations.
15830971|NCT04196907|Device|Rad-67 Pulse CO-Oximeter and DCI Mini sensor|Noninvasive Pulse CO-Oximeter device and sensor are used to measure hemoglobin.
15830972|NCT04196881|Other|Knowledge Improvement Program about ADHD|This training program will cover an overview of ADHD, prevalence, causes, symptoms, risk factors, associated impairment, prognosis, and treatment options including behavioral interventions and medication.
15830973|NCT04196868|Drug|Metformin treatment|1500 mg once a day, per os, during six months
15830974|NCT04196868|Other|Placebo|per os, during six months
15830975|NCT04196868|Drug|Methotrexate treatment|per os
15830976|NCT04196855|Drug|Teriparatide|"Terrosa 20 micrograms/80 microliters solution for injection. Each dose of 80 microliters contains 20 micrograms of teriparatide.
~One cartridge of 2.4 mL of solution contains 600 micrograms of teriparatide (corresponding to 250 micrograms per mL).
~Teriparatide, rhPTH(1-34), produced in E. coli, using recombinant DNA technology, is identical to the 34-N-terminal amino acid sequence of endogenous human parathyroid hormone."
15830977|NCT04196842|Device|Telemonitoring devices|Set of telemonitoring devices: heart rate and blood pressure monitor, scale and activity tracker.
15830978|NCT04196829|Drug|silver diamine fluoride ⁄ potassium Iodide|The affected tooth surface will be gently cleaned and dried with cotton gauze. The gingival tissue of the tooth will be protected with petroleum jelly. An applicator will be dipped into the SDF and 3-4 mg applied to the lesion with microbrush which will be used to paint solution over carious lesion then we will wait for 1 minute till absorption . Then after SDF application KI will be applied using a separate microbrush which will be saturated by the solution and will be used to paint solution over carious lesion , no rinse will be performed and special instructions will be given following application
15830979|NCT04196829|Drug|Silver Diamine Fluoride|The affected tooth surface will be gently cleaned and dried with cotton gauze. The gingival tissue of the tooth will be protected with petroleum jelly. An applicator will be dipped into the SDF and 3-4 mg applied to the lesion with microbrush which will be used to paint solution over carious lesion then we will wait for 1 minute till absorption .
15830980|NCT04196803|Dietary Supplement|Magnesium glycinate|Oral administration of magnesium glycinate daily for 12 weeks
15830981|NCT04196803|Dietary Supplement|Placebo|Oral administration of identical-appearing placebo daily for 12 weeks
15830982|NCT04196777|Behavioral|Audit-and-feedback|We will provide feedback both at baseline and at regular intervals to the 3 intervention sites. At first, we will schedule one-on-one conference calls with urology providers and the antimicrobial stewardship team at each of the 3 intervention sites. These conference calls will include a review of guidelines, a review of the facility's data on excessive post-procedural antimicrobial use for urologic patients, and an anonymous comparison to all other VHA sites. Next, we will prospectively monitor excessive post-procedural antimicrobial use at all 6 sites (3 control, 3 intervention) for 1 year. Data on hospital-level excessive post-procedural antimicrobial use specific to urologic patients (primary outcome) will be sent electronically to urology providers and the antimicrobial stewardship team at the intervention site every other month via electronic mail.
15830983|NCT04196751|Other|Clinical Supervision|After baseline data collection, participants will be invited to attend training on clinical supervision (CS). Education will be delivered in 3 phases. 1-Orientation to the CS model 2-Integration of theory into practice and 3-Skill advancement for supervisors. After training, participants will be encouraged to choose a supervisor, identify objectives for skill development. They will be advised to meet their supervisor once a month for 60 minutes (Due to COVID 19 pandemic the participants can have either one-to-one session in-person or virtually (Microsoft Team), however, if the supervisor and the supervisee working in the same campus can have their one-to-one session as per their preferences. Supervisor-supervisee will be working together to achieve the stated goals. Only the recorded attendance and nature of the session will be used for research purpose. Data will be collected at baseline, 6&12 month with pre-specified tools.
15830984|NCT04196738|Other|ventilation strategy|Patients are ventilated in randomised order with three different ventilation strategies: volume assist control (constant flow), Dual Mode or Airway Pressure Released Ventilation
15830985|NCT04196725|Other|Physical therapy treatment|Two weeks rehabilitation programme focusing on physical therapy treatment, e.g. manual lymphatic drainage and compression bandaging
15830986|NCT04196725|Behavioral|Lifestyle treatment|Two weeks rehabilitation programme focusing on physical activity
15830987|NCT04196699|Behavioral|self-management program|"Our intervention will be based on the following framework and will consist of 3 phases :
~Phase I: At the end of a medical consultation, the doctor will offer the patient the opportunity to benefit from a nursing consultation and remote monitoring to better manage his COPD. A nursing consultation will be scheduled during which the nurse will explain the procedure, obtain the written consent of the patient, and develop an educational diagnosis with the participation of the patient.
~Phase II: During the next six weeks education sessions will be provide to the participants and a telephone number will be available in case of emergency and for any additional information.
~Phase III: A final consultation will be scheduled at the nurse office to evaluate the patient's achievements and modify his/her educational assessment. A telephone follow-up will be conducted after one month to assess the maintenance of learning."
15830988|NCT04196686|Other|VR/AR Use|VR/AR headset with either passive or active content such as playing a game or watching a movie
15830989|NCT04196686|Other|Ice Bath|Participants immerse hand in ice bath and starting again with their original assigned group and keep hand submerged as long as they can withstand the cold or until 4 minutes have elapsed, whichever comes first. Participants will not be told of the specifics of the time limit, to avoid competitiveness and expectations and will be asked for pain scores every 30 seconds.
15830990|NCT04196673|Device|Alcon SN60WF|Implantation of an intraocular lens Alcon SN60WF
15830991|NCT04196673|Device|Hoya Vivinex|Implantation of an intraocular lens Hoya Vivinex
15830992|NCT04196660|Behavioral|Labor Dance|The pregnant women and their spouses were trained about the labor dance in the prenatal training without disclosing any information regarding the delivery and labor pain. The pregnant women and their spouses/partners who wanted to perform the practice were asked to inform the researcher when the labor started. The researcher stayed with the pregnant women and their spouses during the practice and labor process. The pregnant women started to dance with their spouses during the active phase of the labor process accompanied by meditation music (on a YouTube channel named Ohgertam Jugrefem) in a dim, silent environment. The spouse or partner massaged the pregnant woman's sacral area while dancing. During the active phase of labor, the pregnant women in the DPMG danced with the midwives who were attendant in the delivery room and who were monitoring the pregnant women's status.
15830993|NCT04196647|Other|Home titration|Patients have their initial dosage titration of duodopa done in their own home, supported by one visit from nursing staff, and one video consultation a day
15830994|NCT04196634|Other|Risk assessment|People on sick leave due to musculoskeletal conditions will be screened for potential risk factors for prolonged sickness absence. No intervention will be given.
15830995|NCT04196621|Device|High viscous artificial tears|Instillation of one drop high viscous artificial tears
15830996|NCT04196621|Device|Low viscous artificial tears|Instillation of one drop low viscous artificial tears
15830997|NCT04196608|Drug|Ceftolozane/tazobactam|Minimum inhibitory concentrations (MICs) will be determined by the standard broth microdilution method (standard ISO method 20776-1:2006) using dry-form Sensititre panels (Thermo Fisher Scientific, Denmark) and will be interpreted according to the European Committee on Antimicrobial Susceptibility Testing (EUCAST) and the Clinical and Laboratory Standards Institute (CLSI) criteria
15830998|NCT04196608|Drug|imipenem- relebactam|Minimum inhibitory concentrations (MICs) will be determined by the standard broth microdilution method (standard ISO method 20776-1:2006) using dry-form Sensititre panels (Thermo Fisher Scientific, Denmark) and will be interpreted according to the European Committee on Antimicrobial Susceptibility Testing (EUCAST) and the Clinical and Laboratory Standards Institute (CLSI) criteria
15830999|NCT04196582|Device|Comparison of LMA Gastro Airway® and Gastro-Laryngeal Tube in patients who will undergo biliopancreatic procedures.|comparing efficiency and complications of second generation airway devices which can use for gastrointestinally procedures
15831001|NCT04196556|Behavioral|Active Families|This intervention, based on the methodology of meaningful learning, will have two components: group education aimed at parents (caregivers) and and education directed to children in the reviews in consultation. Group education (caregivers) groups will consist of 6 sessions, which will be given every two weeks, as determined in the program's follow-up annex, in the 3 months after the initial assessment. The content of the sessions is defined in attached annex. Regarding the proposed methodology, it has nuances and tools different from the traditional ones to achieve significant learning in the field of health. It is based on participatory methods and a more profound modification of knowledge, skills, emotions and attitudes than the brief advice that is used in family intervention in scheduled consultations.
15831040|NCT04196244|Diagnostic Test|Abdominal or body CT with intravenous contrast|Abdominal or body CT with intravenous contrast
15831041|NCT04196244|Diagnostic Test|Abdominal or body CT without intravenous contrast (native CT)|Abdominal or body CT without intravenous contrast (native CT)
15831075|NCT04195958|Drug|Omalizumab|Omalizumab will be administered by subcutaneous (SC) injection at a dose of 150 milligrams (mg) to 375 mg every 2 or 4 weeks. The dose and frequency will be determined by body weight (kg) and the level of total IgE (IU/mL) measured during screening.
15831002|NCT04196556|Other|STANDARD CARTERA DE SERVICIOS|"An anamnesis or functional assessment on the following aspects:
~o Family history of obesity up to 2nd degree inbreeding. o Nutritional status - metabolic that includes at least no meals/day and daily consumption of liquids, fruits, vegetables, dairy, fats and sugars. o Activity - exercise that includes at least the type and intensity of exercise and time spent on sedentary activities (television, video games or the like). o Self-concept that includes at least the existence or not of behavioral problems and body image problems. o Role - relationships that include at least the performance of extracurricular activities.
~A care plan in relation to identified problems and/or situations reviewed on a biannual basis.
~They will be supplemented with the study-specific variables listed in the data collection notebook."
15831003|NCT04196543|Other|écho-doppler with ultrasonar Sonovue® injection|"During this unique visit they will benefit from 2 imaging exams performed by two different operators:
~Echo-doppler without standard method contrast injection (common practice)
~An echo-doppler with Sonovue® ultrasound injection Ultra_evar method (2.5 ml bolus 2-3 seconds) During this examination, the endoprosthesis and the aneurysm sac will be scanned according to the 4 incidences described above in order to objective whether or not there is a endoleak.
~The patient then performs the control CT-scan prior to discharge from hospital.
~The results of the medical imaging exams will be communicated to them before the hospital discharge, once the CT-scan has been performed.
~A cross-review of the studies will be performed later."
15831004|NCT04196530|Drug|BDB001|BDB001 is an immunotherapy agent.
15831005|NCT04196530|Drug|Atezolizumab|Atezolizumab is a is a fully humanized, engineered monoclonal antibody of IgG1 isotype against the protein programmed cell death-ligand 1 (PD-L1). Atezolizumab has an acceptable preclinical safety profile and is approved as an IV therapy for a variety of advanced malignancies.
15831006|NCT04196517|Other|Educational Tool, PALS|The Patient Activated Learning System is a free, health education platform.
15831007|NCT04196517|Other|WebMD|WebMD is a widely used educational platform for health information.
15831008|NCT04196504|Device|Echocardiograghy, ECG|transthoracic echocariography, 12 lead ECG
15831009|NCT04196491|Biological|bb2121 carfilzomib|CAR-T Cell Therapy
15831010|NCT04196491|Drug|Fludarabine|Lymphodepleting Chemotherapy
15831011|NCT04196491|Drug|Cyclophosphamide|Lymphodepleting Chemotherapy
15831012|NCT04196491|Drug|Lenalidomide|Maintenance Therapy
15831013|NCT04196478|Device|doppler ultrasound|a 7.5 MHz ultrasound (US) linear probe is needed, grey-scale ultrasound and Color Doppler and a minimum display facility of the Doppler velocity spectrum for blood flow calculation are mandatory tools.
15831014|NCT04196465|Drug|IMC-001|IMC-001 is a fully human anti-programmed cell death ligand 1 (PD-L1) recombinant monoclonal antibody that strongly binds to PD-L1 to inhibit its binding to programmed cell death protein 1 (PD-1) or B7-1 (CD80). IMC-001 showed robust dose-dependent efficacy in animal models and no evidence of toxicity in cynomolgus monkeys
15831015|NCT04196452|Drug|Ipilimumab|Specified dose on specified days
15831016|NCT04196439|Procedure|continuous epidural analgesia|injection of local anaesthetic into epidural space
15831017|NCT04196439|Procedure|supra-inguinal fascia iliaca compartment block|ultrasound guided injection of local anaesthetic into fascia iliaca compartment
15831018|NCT04196426|Behavioral|Nutrition education intervention about osteoporosis and calcium|The intervention is designed and developed based on the Intervention Mapping Process and the Health Belief Model. Topics of the intervention include: the importance of osteoporosis and risk factors, role of calcium in bone health and controlling the disease, calcium recommendations and sources, role of vitamin D and physical activity in calcium absorption and bone health, and how to identify calcium-rich foods in the locality and prepare meals with local calcium-rich foods. A recipe booklet containing recipes using local calcium-rich foods will be given to the participants after the end of the two nutrition lessons. Interactive activities are incorporated in each lesson to encourage the participation of participants.
15831019|NCT04196413|Drug|GD2 CAR T cells|Autologous T-Cells transduced with retroviral vector (14g2a-CD8.BB.z.iCasp9) expressing GD2-chimeric antigen receptor
15831020|NCT04196413|Drug|Fludarabine|Fludarabine 25 mg/m2 per day IV for days -4, -3, -2
15831021|NCT04196413|Drug|Cyclophosphamide|Cyclophosphamide 500 mg/m2 per day IV for days -4, -3, -2
15831022|NCT04196400|Drug|steroid betamethasone|The steroid is injected using insulin needle in the subcutaneous tissue after finishing the repair
15831023|NCT04196387|Diagnostic Test|urine culture|urine culture and antibiotic susceptibility test
15831024|NCT04196374|Genetic|Genomic Sequencing|Whole Genome Sequencing and reporting of actionable genomic results for genes included on the ACMG secondary findings list.
15831025|NCT04196361|Diagnostic Test|Ultrasound|Point of care ultrasound as part of routine physical examination
15831026|NCT04196348|Procedure|Short BPL RYGB|Alimentary limb (AL) with 120 cm and BPL with 100 cm.
15831027|NCT04196348|Procedure|Long BPL RYGB|AL with 120 cm and BPL with 200 cm.
15831028|NCT04196335|Device|intra-procedural intracardiac echocardiography|use of intra-procedural intracardiac echocardiography during Watchman FLX devices
15831029|NCT04196322|Other|observational study|observational study
15831030|NCT04196309|Drug|low molecular weight heparin|LMWH (tinzaparin) at body-weight-adjusted therapeutic dose (175 anti-Xa IU/kg subcutaneously once daily)
15831031|NCT04196296|Behavioral|Psychoeducation|Online psychoeducation about social anxiety, evidence-based treatments that target social anxiety, and treatment referral/resource information.
15831032|NCT04196296|Behavioral|Motivation|Online exercises/activities regarding social anxiety (and treatment thereof) based in principles from Acceptance and Commitment Therapy (ACT) and Motivational Interviewing (MI)/Motivational Enhancement Therapy (MET).
15831033|NCT04196283|Drug|ABBV-368|Intravenous (IV) infusion
15831034|NCT04196283|Drug|Tilsotolimod|Intratumoral (IT) injection
15831035|NCT04196283|Drug|Nab-paclitaxel|Intravenous (IV) infusion
15831036|NCT04196283|Drug|ABBV-181|Intravenous (IV) infusion
15831037|NCT04196270|Drug|Ropivacaine injection|In a dose finding study the total volume of ropivacaine changes according to the biased coin up-and-down sequential design
15831038|NCT04196257|Drug|BP1001-A (Liposomal Grb2 Antisense Oligonucleotide)|Dose escalation of BP1001-A intravenously (IV), twice weekly for 4 weeks (28-day cycle) for 6 cycles.
15831073|NCT04195984|Device|Mi-thos® valve and transapical delivery system|Transcatheter mitral valve replacement system
15831042|NCT04196231|Drug|IDegLira|IDegLira will be started at 16 dose steps (16 U insulin degludec plus 0.58 mg liraglutide, once daily). On the basis of prebreakfast self-monitored blood glucose measurements doses of IDegLira will be titrated individually twice per week to achieve a prebreakfast plasma glucose of 80-130 mg/dL by use of an algorithm (adding 2 dose steps for prebreakfast plasma glucose >130 mg/dL; no dose change for prebreakfast plasma glucose of 80-130 mg/dL; reducing 2 dose steps for prebreakfast plasma glucose < 80 mg/dL). The daily dose of IDegLira could be titrated to 50 dose steps (50 U insulin degludec plus 1.8 mg liraglutide).
15831043|NCT04196231|Drug|IGlarLixi|IGlarLixi will be started at 10 dose steps (10 U insulin glargine plus 5 mcg lixisenatide, once daily). On the basis of prebreakfast self-monitored blood glucose measurements, doses of IGlarLixi will be titrated individually once per week to achieve a prebreakfast plasma glucose of 80-130 mg/dL by use of an algorithm (adding 2 dose steps for prebreakfast plasma glucose >130 mg/dL; no dose change for prebreakfast plasma glucose of 80-130 mg/dL; reducing 2 dose steps for prebreakfast plasma glucose < 80 mg/dL). The daily dose of IGlarLixi could be titrated to 60 dose steps (60 U insulin degludec plus 20 mcg lixisenatide).
15831044|NCT04196231|Drug|Insulin/Canaglifozin|Patients in this arm will continue the basal insulin used before the randomization, with dosage titration on the basis of the following algorithm: adding 2 units for prebreakfast plasma glucose >130 mg/dL; no dose change for prebreakfast plasma glucose of 80-130 mg/dL; reducing 2 units for prebreakfast plasma glucose < 80 mg/dL. Moreover, they will be assigned to canaglifozin, according to the current clinical practice and the drugs' data sheet. Canagliflozin will be started at 100 mg daily per oral administration, and augmented to 300 mg/per day if required (HbA1c >7.5 after 12 weeks).
15831045|NCT04196231|Drug|Insulin/Dapaglifozin|Patients in this arm will continue the basal insulin used before the randomization, with dosage titration on the basis of the following algorithm: adding 2 units for prebreakfast plasma glucose >130 mg/dL; no dose change for prebreakfast plasma glucose of 80-130 mg/dL; reducing 2 units for prebreakfast plasma glucose < 80 mg/dL. Moreover, they will be assigned to dapaglifozin, according to the current clinical practice and the drugs' data sheet. Dapagliflozin will be started at 10 mg daily per oral administration
15831046|NCT04196231|Drug|Insulin/Empaglifozin|Patients in this arm will continue the basal insulin used before the randomization, with dosage titration on the basis of the following algorithm: adding 2 units for prebreakfast plasma glucose >130 mg/dL; no dose change for prebreakfast plasma glucose of 80-130 mg/dL; reducing 2 units for prebreakfast plasma glucose < 80 mg/dL. Moreover, they will be assigned to empaglifozin, according to the current clinical practice and the drugs' data sheet. Empagliflozin will be started at 10 mg daily per oral administration, and augmented to 25 mg/per day if required (HbA1c >7.5 after 12 weeks).
15831047|NCT04196231|Drug|Basal Bolus|Patients in this arm will continue the basal insulin (glargine, degludec or glargine-300) used before the randomization. The insulin titration will be guided by the medical staff, according to the following algorithm: adding 2 units of basal insulin for prebreakfast plasma glucose >130 mg/dL; no dose change for prebreakfast plasma glucose of 80-130 mg/dL; reducing 2 units of basal insulin for prebreakfast plasma glucose < 80 mg/dL. The short acting insulin analogue (lispro, aspart or glulisine) will be started at the dosage of 4 units before meals (3 times per day) and will be titrated twice a week until achieving pre-prandial glucose values ranging from 80-130 mg/dL.
15831048|NCT04196218|Other|Driving simulator|Computer simulated driving assessment
15831049|NCT04196205|Biological|Anti-CD19 CAR-T|1 - 2×10^6 Anti-CD19 CAR-T cells/kg body weigh
15831050|NCT04196179|Drug|ANG3070|ANG-3070 drug product is a an immediate release oral solid. The drug product consists of a Size 00 Swedish orange capsule containing drug substance (10 mg, 50 mg, or 250 mg) with no excipients.
15831051|NCT04196179|Drug|Placebo oral capsule|ANG-3070 placebo capsules visually match the drug product.
15831052|NCT04196166|Other|preoperative blood tests|
15831053|NCT04196153|Procedure|Pedicle screws instrumentation|The screws are inserted in two or more consecutive levels to prevent motion at the segments that are being fused. It will be done using one of the two guidance technique depending on which arm the patient will be randomized to.
15831054|NCT04196140|Device|Omnipod Horizon™ Automated Glucose Control System|The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
15831055|NCT04196127|Other|Bite force testing|Maximum bite force examination with a force intra-oral measuring device
15831056|NCT04196114|Device|STIMO-2 device implantation|Implantation of SCS lead in epidural space and implantation of neurostimulator in abdominal region
15831057|NCT04196101|Drug|EDP-938|Four tablets daily for 5 days
15831058|NCT04196101|Drug|Placebo|Four tablets daily for 5 days
15831059|NCT04196088|Device|Ultivision Artificial Intelligence Software|Screening Colonoscopy
15831060|NCT04196088|Device|No Artificial Intelligence Software enhancement|Screening Colonoscopy
15831061|NCT04196075|Drug|Andrographis Paniculata|AP as palliative treatment
15831062|NCT04196062|Device|EndoMASTER EASE Robotic system for ESD|EndoMaster EASE System, is a robotic-assisted endoscopy system indicated for endoscopic visualization and therapeutic access to the adult gastrointestinal (GI) tract for endoscopic surgery
15831063|NCT04196049|Procedure|fragmatome|Patients with massive subretinal hemorrhage from age related macular degeneration and organized subretinal blood clot were managed by inferior retinectomy. The subretinal organized blood clot was dragged to the preretinal space and removed by fragmatome. The retinal was reattached with perfluorocarbon liquid and laser was applied at the margin of retinectomy. Silicon oil was infused at the end of surgery.
15831064|NCT04196036|Procedure|Day of vitrification|Supernumerary embryos after fresh transfer on Day 3 after oocyte aspiration are either vitrified on Day 3 or are kept in culture until Day 5 and vitrified on Day 5
15831065|NCT04196023|Dietary Supplement|Magnesium glycinate|Oral administration of magnesium glycinate daily for 12 weeks
15831066|NCT04196023|Dietary Supplement|Placebo|Oral administration of identical-appearing placebo daily for 12 weeks
15831067|NCT04196010|Drug|Cladribine|Given IV
15831068|NCT04196010|Drug|Cytarabine|Given IV
15831069|NCT04196010|Biological|Recombinant Granulocyte Colony-Stimulating Factor|Given subcutaneously
15831070|NCT04196010|Drug|Mitoxantrone|Given IV
15831071|NCT04195997|Drug|Bivalirudin|Patients would be given anticoagulant therapy with bivalirudin in left atrial appendage occusion.
15831072|NCT04195997|Drug|Heparin|heparin during left atrial appendage occlusion.
15831079|NCT04195945|Biological|Recombinant Granulocyte Colony-Stimulating Factor|Given SC
15831080|NCT04195945|Drug|Mitoxantrone|Given IV
15831081|NCT04195945|Other|Questionnaire Administration|Ancillary studies
15831082|NCT04195945|Other|Quality-of-Life Assessment|Ancillary studies
15831083|NCT04195932|Other|Exercise training|
15831084|NCT04195919|Drug|Evogliptin 5mg|Participants receive Single oral administration of Evogliptin 5mg on day1
15831085|NCT04195919|Drug|Evogliptin 5mg|"Period 1(1d,After hemodialysis) → Wash-out period → Period 2(15d,Before hemodialysis)
~Hemodialysis patients receive Single oral administration of Evogliptin 5mg on day1 and day15 With a 14-day washout period"
15831086|NCT04195906|Drug|Experimental: SNF472|Administered 3 times weekly by intravenous infusion through the hemodialysis machine in conjunction with the subject's hemodialysis sessions for 12 weeks
15831087|NCT04195906|Drug|Placebo Comparator: Placebo|Administered 3 times weekly by intravenous infusion through the hemodialysis machine in conjunction with the subject's hemodialysis sessions fo 12 weeks
15831088|NCT04195906|Drug|Experimatenl SNF472 (Open-label)|Administered 3 times weekly by intravenous infusion through the hemodialysis machine in conjunction with the subject's hemodialysis sessions for 12 weeks
15831089|NCT04195893|Device|somofilcon A|Contact Lens
15831090|NCT04195893|Device|etafilcon A|Contact Lens
15831091|NCT04195880|Other|Interventions to Reduce Acute Care Transfers|Experimental CLCs were trained in INTERACT QI Intervention, containing tools, strategies and educational resources designed to catch and manage acute changes in conditions early that a Veteran may be experiencing, leading to a potential reduction in preventable hospital transfers from CLCs.
15831092|NCT04195867|Drug|Salmeterol Xinafoate|Subjects receive a daily inhaled dose of 200 μg (4 inhalations of 50 μg each).
15831093|NCT04195854|Device|P4HB product|Retrospective use of P4HB in various anatomies
15831094|NCT04195841|Procedure|Z shaped incision|"After local anaesthesia, a mucoperiosteal flap will be elevated at the edentulous ridge with two horizontal incisions placed with a no MB 69 blade, 1-2 mm away from the papilla of the teeth adjacent to the edentulous space following the mesial and distal contour of the teeth. The extend of the incisions should be up to the proximal line angles of the adjacent teeth. These two horizontal incisions are then connected by an oblique incision from the disto-buccal to mesio lingual point angles. A periosteal elevator is used to elevate a full thickness mucoperiosteal flap buccally and lingually to the level of the mucogingival junction, exposing the alveolar ridge of the implant surgical sites.
~Endosseous implant placement is done followed by simple interrupted resorbable sutures"
15831095|NCT04195841|Procedure|H shaped incision|"After local anaesthesia, a mucoperiosteal flap is elelevated by placing sulcular incisions placed in the proximal sides of the adjacent tooth facing the edentulous space in a bucco lingual direction extending between the proximal line angles using a MB 69 blade.
~Mid crestal incision performed in the attached mucosa of the edentulous area connecting the sulcular incisions of the adjacent teeth from the distal to mesial tooth. A full thickness mucoperiosteal flap will be elevated buccally and lingually to the level of the mucogingival junction to expose the alveolar ridge of the implant surgical sites using a periosteal elevator.
~Endosseous implant will be placed, followed by simple interrupted resorbable sutures."
15831096|NCT04195828|Drug|Camrelizumab|Camrelizumab One course will last 21 days.Given once every 3 weeks at a dose of 200 mg.
15831097|NCT04195828|Drug|Apatinib Mesylate|Apatinib One course will last 21 days.Oral administration at a dose of 250 mg everyday。
15831098|NCT04195828|Drug|nab-paclitaxel|nab-paclitaxel One course will last 21 days。Given twice every 3 weeks at a dose of 125 mg/m2.
15831099|NCT04195828|Drug|S1|S-1 was calculated according to body surface area , P.O., bid, d1-d14。And the dosage according body surface area:<1.25m2, 40mg every time;1.25-1.5m2,50mg every time; >1.5m2, 60mg every time
15831100|NCT04195802|Other|Salt and potassium Diet|Self-administration questionnary to evaluate the salt and potassium consumption
15831101|NCT04195789|Other|Lung sonography|"Realization of a lung sonography with scoring of the number of B-lines exploring 14 intercostal spaces.
~Duration of the exam : twenty minutes. Recording for a second analysis by another lung specialist."
15831102|NCT04195776|Drug|Tenofovir Douche|660 mg TFV in 125 mL hypo-osmolar solution
15831103|NCT04195763|Drug|asfotase alfa|This is an observational study and no intervention will be administered. All participants will be treated by their physician in accordance with standard of care. All medications are commercially available and will be used as directed by the treating physician.
15831106|NCT04195737|Procedure|Ossix volumax collagen matrix|Under LA horizontal incision is made.Split-full-split thickness flap is elevated.The remaining soft tissue of the anatomic interdental papillae deepithelialized.Coronal advancement of the flap obtained and closed using sling suture.
15831107|NCT04195737|Procedure|Connective Tissue Graft|Under LA parallel incisions is made 1-2 mm first molar to canine.Graft incision 1 mm coronal to the horizontal flap incision.Through this incision designed graft thickness is obtained.The graft obtained between the two horizontal incisions has a 1 mm coronal strip that require depithelisation with a knife and closed using interrupted suture.
15831108|NCT04195724|Other|mNGS for pathogen detection|mNGS for pathogen detection and metabonomics (ascites, fecal,venous blood from superior mesenteric vein, hepatic vein and peripheral vein, respectively)
15831109|NCT04195711|Diagnostic Test|"objective pediatric vision screen, blinq,"|hand-held birefringent screener for simultaneous foveation
15831110|NCT04195698|Drug|Upadacitinib|Upadacitinib will be administered oral as tablet
15831142|NCT04195438|Diagnostic Test|ABG Testing Pre/Post Hepatic Resection|Monitor carboxyhemoglobin(COHb) in the arterial blood gas of patients before liver resection at 4 hours and 24 hours after PH
15831143|NCT04195438|Diagnostic Test|CT Evaluations|Analyze the relationship between CO production and the extent of hepatic resection assessed by computed scans liver volumetric study at one and three months after PH, size and weight of the resected specimen and operative report
15831199|NCT04195009|Procedure|major surgery under opioid free anesthesia without regional anesthesia|measuring nociception in every patient but blinded for attending anesthesiologist
15831200|NCT04194996|Procedure|Surgical intervention|Surgical interventions will be patient specified by treating surgeon.
15831201|NCT04194983|Dietary Supplement|Fish oils and dairy fat|12-weeks, 3x per day
15831111|NCT04195685|Procedure|Neurofeedback (NFB)|Participants are seated in a comfortable chair and have common EEG electrodes with a pre-application of EEG adhesion conductive paste placed on scalp. The participant will receive coaching as they look at the game training screen and focus on the image. The game training screen provides almost instantaneous feedback (within 200 milliseconds) to participants about brain functioning. Twenty, one-hour, NFB training sessions will be provided by a trained NFB specialist over an 8-10-week period with up to 5-sessions but usually 3 sessions a week. The specific NFB special use system that will be used is the Cygnet NFB System from Bee Medic Corporation. The latest technological advances in this system has enabled training frequencies in the infra-low frequency range as well as in all other relevant frequency ranges which is a breakthrough capacity not available on any other NFB system. This will enable the individualized training to the person's brain training preference.
15831112|NCT04195672|Device|NIPE (MDoloris®) and CBS values|"During different procedures of care with the bed-side nurse, NIPE ware recorded. Monitoring started 15 minutes before care and continuously recorded until 10 minutes after the procedure. Pain assessment was evaluated by the CBS under 3 periods for each patient: 1- before any procedure (T1) representing the baseline, 2- during the procedure of care (T2), and 3- after the procedure (T3). Investigator who performed the CBS was blind to NIPE during the procedure recording.
~This study did not change the procedure of care before or after and had no impact on care"
15831113|NCT04195659|Procedure|Mastectomy and chest masculinization|A surgical procedure in which the breasts are removed and the chest is given a masculine contour.
15831114|NCT04195646|Device|EndoVigilant CAD Software|The CAD software is deep learning algorithm used to aid in the detection of polyps (abnormal tissue growths in the wall of the colon and adenomas (pre-cancerous growths) during colonoscopy. In its current form, the CAD software is installed on a computer system unit that utilizes an an operating system.
15831115|NCT04195633|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic hematopoietic stem cell transplantation
15831116|NCT04195633|Drug|Cyclophosphamide|Given IV
15831117|NCT04195633|Drug|Cyclosporine|Given IV or PO
15831118|NCT04195633|Biological|Filgrastim|Given IV
15831119|NCT04195633|Drug|Fludarabine|Given IV
15831120|NCT04195633|Drug|Mycophenolate Mofetil|Given IV or PO
15831121|NCT04195633|Drug|Mycophenolate Sodium|Given PO
15831122|NCT04195633|Radiation|Total-Body Irradiation|Undergo total-body irradiation
15831123|NCT04195633|Drug|Treosulfan|Given IV
15831124|NCT04195620|Other|High self-disclosure|"The high self-disclosure condition involves individuals asking and answering a series of questions that are more personal in nature and involve sharing or receiving information that is likely to be emotionally laden and information that is not readily shared in typical conversations. An example of a question from this condition includes If you were to die today without the chance to speak with anyone, what would you most regret not having said to someone? Why haven't you said it yet?"
15831125|NCT04195620|Other|Low self-disclosure|"The low self-disclosure condition involves individuals asking and answering a series of questions that are not personal in nature and involve sharing or receiving information that is shared in very casual conversations. An example of a question from this condition includes What did you do to celebrate Halloween last year?"
15831126|NCT04195594|Other|Nic's Keto Diet|Participants will be instructed to follow Nic's keto diet plan for 140 days. They will be asked to not exceed 20 g of carbohydrates (up to 5% caloric intake) and to consume the remaining 70% of calories from fat sources and 25% from protein sources.
15831127|NCT04195581|Device|comfilcon A|Subjects were randomized to wear each lens and solution combination for a month.
15831128|NCT04195581|Device|fanfilcon A|Subjects were randomized to wear each lens and solution combination for a month.
15831129|NCT04195568|Device|Surpass Evolve Flow Diverter System|The Surpass Evolve Flow Diverter System is indicated for the endovascular treatment of adults (age 18 or above) with unruptured saccular wide-neck or fusiform intracranial aneurysms ≤12 mm.
15831131|NCT04195542|Other|Questionnaire|questionnaire assessing knowledge of the need to take vitamin B9 supplementation in women in the periconceptional period and the reasons why this supplementation is carried out or not
15831132|NCT04195529|Genetic|presence of genetic variants|identification of the presence of genetic variants
15831133|NCT04195516|Other|web based training,individual counseling, using reminders|"Health Promotion Model based Health Promotion Program will be applied to the experimental group. Health promotion program; The Web-based Health Promotion Program includes individual counseling and reminder practices.
~Within the context of the Web Based Health Promotion Program, 8 weeks of training to improve healthy eating and physical activity behaviors, individual counseling will be given.
~Colorful picture reminders will be sent to the experimental group through Whatsapp groups.
~At the end of the intervention, cognitive and physical measurements of the students will be done at 1st, 3rd and 6th months."
15831134|NCT04195503|Procedure|Liver Transplantation|Surgical removal of liver containing tumor(s) and transplantation of new healthy liver graft
15831135|NCT04195490|Procedure|feminizing genitoplasty|feminizing genitoplasty including vaginoplasty,clitroplasty, labioplasty and urethroplasty
15831136|NCT04195477|Behavioral|vDPP|The to be developed vDPP curriculum as part of the early stages of this study will be piloted.
15831137|NCT04195464|Other|Dry needling|Dry needling is a skilled intervention that uses a thin filiform needle to penetrate the skin and stimulate underlying myofascial trigger points, muscular, and connective tissues for the management of neuromusculoskeletal pain and movement impairments
15831138|NCT04195464|Other|Sham dry needling|Sham Dry needling use a non-penetrating acupuncture needle
15831139|NCT04195451|Other|Live-Video-Supervised Exercise Intervention|The live-video-supervised exercise intervention includes exercise sessions x3/week for 3 months, and then maintenance regimen for 6 months. Maintenance includes live-video-supervised exercise sessions, only x1/week, and self-exercise x2/week following an individualized prescribed exercise program and use their heart rate monitor as an activity tracker.
15831140|NCT04195451|Other|Usual Care then Live-Video Supervised Exercise Intervention|Patients randomized to usual care at baseline will receive usual care for 9 months and will then start the live-video-supervised exercise intervention that includes exercise sessions x3/week for 3 months.
15831141|NCT04195438|Procedure|CO Testing Pre/Post Hepatic Resection|Monitor CO in exhaled air of patients before liver resection, at 4 hours and 24 hours after PH
15831144|NCT04195412|Device|tDCS + upper limb rehabilitation|Stimulation will be applied for 20 minutes by a DC stimulator (NeuroConn, Germany). During each stimulation section, a pair of saline-soaked sponge electrodes (surface 24 cm²) will be placed over C3 and C4, according to the International 10-20 EEG system. Stimulation intensity will be 2 mA with current ramping up and down of 10 seconds each. The stimulation will be followed by 40 minutes of upper limb rehabilitation. Experimental sessions will be repeated five times per week to complete 10 sessions.
15831145|NCT04195412|Device|Sham tDCS + upper limb rehabilitation|Sham stimulation will be applied for 20 minutes by a DC stimulator (NeuroConn, Germany). During each sham stimulation section, a pair of saline-soaked sponge electrodes (surface 24 cm²) will be placed over C3 and C4, according to the International 10-20 EEG system. The anode will be placed to the affected hemisphere, while the cathode will be positioned over the unaffected hemisphere. Sham tDCS will be performed by ramping current flow for the first 10 seconds of stimulation, but switching the stimulator off automatically after 30 seconds. The sham stimulation will be followed by 40 minutes of upper limb rehabilitation. Experimental sessions will be repeated five times per week to complete 10 sessions.
15831149|NCT04195386|Procedure|Dental Restoration with Chemically activated Composite resin Alkasite|Selective removal of dental caries with manual instruments, under relative isolation, application of universal adhesive system and restoration with chemically activated composite resin Alkasite.
15831150|NCT04195386|Procedure|Dental Restoration with Resin-Modified Glass ionomer Cement|Selective removal of dental caries with manual instruments, under relative isolation, application of polyacrylic acid and restoration with resin-modified glass ionomer cement.
15831151|NCT04195373|Biological|TMV-018 + 5-FC|"TMV-018: liquid frozen, life attenuated, oncolytic measles virus encoding the prodrug converting enzyme super cytosine deaminase; 1E+06 TCID50 to 1E+08 TCID50 per dose.
~5-FC: 150 mg/kg/day for 2 days during each treatment."
15831152|NCT04195373|Biological|TMV-018 + anti-PD-1|"TMV-018: liquid frozen, life attenuated, oncolytic measles virus encoding the prodrug converting enzyme super cytosine deaminase; 1E+06 TCID50 to 1E+08 TCID50 per dose.
~Anti-PD-1 inhibitor dose according to its SMPC."
15831153|NCT04195373|Biological|TMV-018 + 5-FC + anti-PD-1|"TMV-018: liquid frozen, life attenuated, oncolytic measles virus encoding the prodrug converting enzyme super cytosine deaminase; 1E+06 TCID50 to 1E+08 TCID50 per dose.
~5-FC: 150 mg/kg/day for 2 days during each treatment cycle.
~Anti-PD-1 Inhibitor: dose according to its SMPC."
15831154|NCT04195360|Other|Standardized mobilization procedure|5 minutes bed rest (h1), followed by 3 minutes passive leg raise (PLR), followed by 5 minutes bed rest (h2), followed by 3 minutes sitting on the egde of the bed (sit), followed by 3 minutes standing/walking on the spot (sta), followed by 5 minutes bedrest (h3)
15831155|NCT04195347|Drug|CM4620|IV
15831156|NCT04195334|Device|internal fixation by IMN|using retrograde or antegrade IMN for femooral fractures fixation using a fit nail to the femoral intramedullary canaland follow up for union
15831157|NCT04195321|Drug|Norepinephrine|infusion will be started after induction of spinal anesthesia
15831158|NCT04195321|Drug|phenylephrine|infusion will be started after induction of spinal anesthesia
15831159|NCT04195308|Device|Active TBS-DLPFC|"Participants in the active stimulation group will receive intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004).
~Stimulation will be delivered to the L-DLPFC using a MagPro stimulator."
15831160|NCT04195308|Device|Sham TBS-DLPFC|The parameters in the active arms will be as above with the internal randomization of the device internally switching to sham in a blinded fashion.
15831161|NCT04195308|Device|Open label TBS-DLPFC|"Patients will have the option of receiving active, open label aTBS treatment following sham.
~Stimulation will be delivered to the L-DLPFC using a MagPro stimulator or Nexstim TMS device."
15831162|NCT04195295|Procedure|Regeneration of Intrabony Defects with Nano Hydroxyapatite Graft, Derived from Egg Shell along with Periosteum as Barrier Membrane|"In group A, the full thickness mucoperiosteal flap will be elevated, which will be extended apically to expose sufficient amount of periosteum.
~Periosteal membrane will be separated from the full thickness mucoperiosteal flap and released by one vertical incision mesially and one horizontal incision apically.
~Posteriorly, the periosteum remained attached with the mucoperiosteal flap, so that blood supply could be maintained in the reflected periosteum.
~Then the graft material will be packed into the defect.
~Then periosteal membrane will be turned over the intrabony defect in such a way that the defect was completely covered by the periosteal membrane"
15831163|NCT04195295|Procedure|Regeneration of intrabony defects using Egg shell derived nano hydroxyapatite (EnHA) as regenerative graft material|Full thickness mucoperiosteal flap will be raised and Vertical releasing incisions are used if necessary for better access to the surgical site. Then EnHA graft material will be placed into the defect before suturing the mucoperiosteal flap.
15831164|NCT04195295|Procedure|Open flap debridement procedure in intrabony defects.|full thickness mucoperiosteal flap will be raised, entire granulation tissue will be removed from the defects, the pocket epithelium was curetted from the inner surface of the flap, and the roots were thoroughly scaled and planed by means of manual and ultrasonic instruments. Then the operative area will be irrigated with sterile saline. After that, the mucoperiosteal flaps will be sutured.
15831165|NCT04195282|Other|Plasma exchange|Patients will receive treatment of plasma exchange for three times in two weeks. The volume of fresh frozen plasma used in plasma exchange is about 2000 millilitre per time.
15831166|NCT04195282|Other|RL-1 Novel Human-derived Bio-artificial Liver Treatment|Patients will receive RL-1 Novel Human-derived Bio-artificial Liver treatment for three times in two weeks. The volume of plasma exchanged in the system is about 4000 millilitre per time.
15831167|NCT04195269|Drug|Test Article|10 mg CBD, 10 mg of THC, and a proprietary blend of terpenes.
15831168|NCT04195256|Drug|IN Ketodex (D4K2)|Dexmedetomidine (Pfizer, Kirkland, Quebec), single-dose, 4 mcg/kg (0.04 mL/kg) of 100 mcg/mL solution, maximum of 200 mcg (2 mL) THEN Ketamine (Sandoz, Mississauga, Ontario), single dose, 2 mg/kg (0.04 mL/kg) of 50 mg/mL solution, maximum of 200 mg (4 mL) (D4K2), both delivered intranasally using a mucosal atomizer device (MAD) and divided to both nares AND 0.9% normal saline 0.03 mL/kg delivered intravenously to a maximum of 2 mL
15831169|NCT04195256|Drug|IN Ketodex (D3K3)|Dexmedetomidine (Pfizer, Kirkland, Quebec), single-dose, 3 mcg/kg (0.03 mL/kg) of 100 mcg/mL solution, maximum of 200 mcg (2 mL) THEN Ketamine (Sandoz, Mississauga, Ontario), single dose, 3 mg/kg (0.06 mL/kg) of 50 mg/mL solution, maximum of 300 mg (6 mL) (D3K3), both delivered intranasally using a mucosal atomizer device (MAD) and divided to both nares AND 0.9% normal saline 0.03 mL/kg delivered intravenously to a maximum of 2 mL
15831170|NCT04195256|Drug|IN Ketodex (D2K4)|Dexmedetomidine (Pfizer, Kirkland, Quebec), single-dose, 2 mcg/kg (0.02 mL/kg) of 100 mcg/mL solution, maximum of 200 mcg (2 mL) THEN Ketamine (Sandoz, Mississauga, Ontario), single dose, 4 mg/kg (0.08 mL/kg) of 50 mg/mL solution, maximum of 400 mg (8 mL) (D2K4), both delivered intranasally using a mucosal atomizer device (MAD) and divided to both nares AND 0.9% normal saline 0.03 mL/kg delivered intravenously to a maximum of 2 mL
15831171|NCT04195256|Drug|IV Ketamine|Ketamine, single dose, 1.5 mg/kg (0.03 mL/kg) of 50 mg/mL solution delivered intravenously, to a maximum of 100 mg (2 mL) AND two aliquots of 0.9% normal saline in 3 possible combinations: (i) 0.04 mL/kg (max 2 mL) then 0.04 mL/kg (max 4 mL) (placebo D4K2), (ii) 0.03 mL/kg (max 2 mL) then 0.06 mL/kg (max 6 mL) (placebo D3K3), (iii) 0.02 mL/kg (max 2 mL) then 0.08 mL/kg (max 8 mL) (placebo D2K4), delivered intranasally using a MAD and divided to both nares
15831172|NCT04195243|Drug|Dapagliflozin Pill|The patient will take one pill, every 24 hr, during 7 days
15831173|NCT04195243|Drug|Empagliflozin Pill|The patient will take one pill, every 24 hr, during 7 days
15831174|NCT04195243|Drug|Placebo pill|The patient will take one pill, every 24 hr, during 7 days
15831175|NCT04195230|Behavioral|Multi-tasking Training|Participants will undergo training protocol where they will have, concomitantly, to cook different meals and set the table under different instructions, rules and difficulty level.
15831176|NCT04195217|Behavioral|Art therapy|"When the patient is placed in a treatment room, a nurse or the ARC proposes to complete the questionnaires corresponding to his visit in accordance with the diagram of the investigations, then retrieve the questionnaire and forward it to the art therapist Then, the art therapist intervenes ans propose different Artistic supports : paint, watercolor pencils, pastels, pencils, clay , origami, music in as an accompaniment to artistic creation.
~The workshop runs from 30 minutes to 2:30. It can be cut by doctors and nurses interventions during medical care. The limit of care is set at 2:30 for reasons of concentration of the patient, organization of the service but the patient is an actor of his care, and chooses when the session ends.
~At the end of intervention, the nurse or the ARC proposes at patient to complete the end questionnaire. Theses last are retrieve it and to forward it to the art therapist."
15831177|NCT04195204|Drug|Tropisetron|Investigators administrated intravenously Tropisetron 5mg before anesthesia and once daily for 7 days after surgery.
15831178|NCT04195204|Drug|Placebos|Investigators administrated intravenously saline solution as a placebo
15831179|NCT04195191|Other|ANM|communication intervention
15831180|NCT04195191|Other|Placebo|regular assistance in community pharmacies
15831181|NCT04195165|Behavioral|SIT|For the SIT and SIT+EX conditions, the subject will be asked to take <3,000 steps. This is meant to achieve ~12-13 hours of sitting per day, are the investigators are measuring the effect of inactivity and exercise on insulin sensitivity.
15831182|NCT04195165|Behavioral|ACTIVE|For the ACTIVE+EX condition, the subject will be asked to take >10,000 steps for the two intervention days. This is meant to simulate an active lifestyle.
15831183|NCT04195165|Behavioral|EX|The SIT+EX and ACTIVE+EX conditions will include an exercise bout on the evening of the second intervention day, and have the oral glucose tolerance test the next morning.
15831184|NCT04195152|Other|Observational|No intervention
15831185|NCT04195139|Drug|Nivolumab|Participants will receive Nivolumab intravenous infusions (240 mg days 1 and 15 every 28 days for cycles 1-4; then 480 mg day 1 every 28 days for cycles 5-6).
15831186|NCT04195139|Drug|Temozolomide|Participants will receive temozolomide (TMZ) tablets days 1-5, every 28 days for 6 cycles. TMZ will be dosed at 150mg/m2 for the first cycle. If well tolerated TMZ is then given at 200mg/m2 for cycles 2 - 6.
15831187|NCT04195126|Device|CytoSorb haemadsorption device|CytoSorb (Cytosorbents Inc.) aspecific blood purification device used in an extracorporeal circulation system without dialysis column. Anticoagulation is managed by siodium citrate-Calcium system, using the Gambro CVVHDF capable device.
15831188|NCT04195100|Drug|Pilocarpine Ophthalmic Solution|"low dose pilocarpine = 3 x 2.0 mg = 3 x 2 drops of pilocarpine 20.0 mg/ml (2%) per day
~high dose pilocarpine = 3 x 5.0 mg = 3 x 5 drops of pilocarpine 20.0 mg/ml (2%) per day"
15831189|NCT04195087|Device|Masimo Radical-7® Pulse CO-Oximeter®|The perfusion index and Pleth variability index will be recorded from the device monitor.
15831190|NCT04195074|Drug|Entecavir|Patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day.
15831191|NCT04195074|Drug|Tenofovir Disoproxil Fumarate|Patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day.
15831192|NCT04195074|Drug|Tenofovir Alafenamide|Patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day.
15831193|NCT04195061|Procedure|Cardiopulmonary exercise test (CPET)|CPET studies will be performed in the Cardiovascular Performance Program exercise lab at MGH. Subjects will undergo CPET on an upright cycle ergometer with continual measurement of metabolic gas exchange via a commercially available metabolic cart as well as heart rate and blood pressure. Exercise will proceed according to a maximal effort clinical protocol. Subjects will then undergo a standardized 30-min work load on the upright cycle ergometer based on the results of the maximal effort clinical protocol.
15831194|NCT04195048|Other|Risk factors|Risk factors: modifiable and unmodifiable risk factors
15831195|NCT04195035|Device|Air-Q intubating laryngeal airway|Air-Q intubating laryngeal airway will be used for ventilation & intubation through fiberoptic bronchoscope.
15831196|NCT04195035|Device|Ambu-Aura intubating laryngeal mask|Ambu-Aura intubating laryngeal mask will be used for ventilation & intubation through fiberoptic bronchscope.
15831197|NCT04195022|Procedure|Dental Restoration with Chemically activated Composite resin Alkasite|Selective removal of dental caries with manual instruments, under relative isolation, application of universal adhesive system and restoration with chemically activated composite resin Alkasite.
15831198|NCT04195022|Procedure|Dental Restoration with Bulk fill resin composite|Selective removal of dental caries with manual instruments, under relative isolation, application of universal adhesive system and restoration with bulk fill resin composite.
15831274|NCT04194515|Drug|YH1|YH1 treatment for one month
15831202|NCT04194983|Dietary Supplement|Fish oils and plant fat|12-weeks, 3x per day
15831203|NCT04194970|Device|With MarWAS device to monitor compliance of specified weight bearing limits data in live feedback on and off situations|"Weight Bearing Protocol (Duration: Post-Op. 6 week)
~Post-op 3 week non-weight bearing (%0 body weight of patient)
~Post- op 3 week touch down weight bearing (%10-%20 body weight of patient) Group I - monitoring with device while the live feedback mechanism turned on Group II- monitoring with device while the live feedback mechanism turned off"
15831204|NCT04194957|Drug|Fluoropyrimidine (capecitabine or 5-fluorouracil)|Patients that are found to be wild type and have a pre-treatment uracil concentration above 16 ng/mL will receive a reduced dosage of capecitabine or 5-fluorouracil (50% reduction). The dose will be titrated after 2 cycles , to achieve maximal safe exposure. Patients that are wildtype with a uracil concentration below 16 ng/mL will receive a normal (full) dose.
15831205|NCT04194957|Drug|Fluoropyrimidine (capecitabine or 5-fluorouracil)|Patients that are heterozygous carriers of c.1236G>A or c.2846A>T DPYD variant will receive a reduced dosage of capecitabine or 5-FU (50 % reduction). The dose will be titrated after 2 cycles, to achieve maximal safe exposure.
15831206|NCT04194957|Drug|Fluoropyrimidine (capecitabine or 5-fluorouracil)|Patients with homozygous or compound heterozygous DPYD variants will be treated with a reduced dose of capecitabine or 5-FU based on the DPD enzyme activity measured in peripheral blood mononuclear cells.
15831212|NCT04194931|Biological|Autologous BCMA CAR-T cells and CD19 CAR-T cells|Autologous BCMA CAR-T cells and CD19 CAR-T cells with average 1-5*10^6 cells/kg body weight,separately.
15831213|NCT04194918|Behavioral|Computer-Assisted Smoking Cessation Intervention|Use the Flexiquit+ program
15831214|NCT04194918|Other|Text Message|Receive text messages
15831215|NCT04194918|Other|Handout|Receive handouts via email
15831216|NCT04194918|Other|Questionnaire Administration|Ancillary studies
15831217|NCT04194918|Other|Quality-of-Life Assessment|Ancillary studies
15831218|NCT04194918|Other|Survey Administration|Ancillary studies
15831219|NCT04194905|Drug|Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 mg Test Product|Coated Tablets
15831220|NCT04194905|Drug|Levonorgestrel 0.1 mg and Ethinyl estradiol 0.02 mg Reference Product|Coated Tablets
15831221|NCT04194892|Biological|Pegilodecakin|Administered SQ
15831222|NCT04194879|Diagnostic Test|multi-target FIT-DNA analysis|ColoClear® is intended for use as an adjunctive screening test for the detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. It has the potential of increasing the sensitivity of detecting CRC as compared to FOBT or faecal immunochemical test (FIT), which detects the presence of hemoglobin in stool alone. A positive result may indicate the presence of colorectal cancer or pre-malignant colorectal neoplasia. ColoClear® is not intended as a replacement for diagnostic colonoscopy. A positive result in ColoClear®, as with any screening test, should be followed by colonoscopy. ColoClear® is intended for colorectal cancer screening in average risk individuals: adults of either sex, 40 years or older, who are at high risk for colorectal cancer.
15831223|NCT04194866|Other|receiving operation during the day or at night|120 patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were randomly assigned to receive operation in the Day Group (8:00-12:00) and in the Night Group (18:00-22:00)
15831224|NCT04194853|Device|Electromyographic Biofeedback|Surface EMG biofeedback is an adjunct therapy to standard exercise regime for increasing muscle strength .Electromyographic (EMG) biofeedback is a specific form of biofeedback. The biofeedback device records muscle activity through the application of electrodes superficially or subcutaneously when targeting specific muscles
15831225|NCT04194853|Other|Quadriceps Isometric exercises|In supine lying or sitting, Patient is asked to press down knee while contracting Quadriceps muscles.
15831226|NCT04194840|Other|physical therapy consult|Physical therapy consult to assess physical functioning on a separate office visit prior to attending the Transplant Wellness Clinic. Full evaluation that incorporates several tools to measure the risk of falling and to assess mobility and strength
15831227|NCT04194840|Other|Cognitive Assessment|Montreal cognitive assessment (MoCA) and the Blessed Orientation-Memory-Concentration Test (BOMC)
15831228|NCT04194840|Other|Cancer Aging Research Group (CARG) assessment|CARG assessment - utilized to capture information about a participant's medical history as well as functional, cognitive, and psychosocial status
15831229|NCT04194840|Other|Medication Review|Medication Review via Beers Assessment
15831230|NCT04194840|Other|Nutrition assessment|Nutrition assessment Via Mini Nutrition Assessment (MNA)
15831231|NCT04194840|Other|Laboratory studies|Laboratory studies including urine toxicology screen, C-reactive protein, albumin, pre-albumin, vitamin D
15831232|NCT04194840|Other|Patient satisfaction questionnaire|Patient satisfaction questionnaire
15831233|NCT04194840|Other|Physician Questionnaire|"Physician Questionnaire:
~Questionnaire to learn about physician satisfaction with information received from reports and participant questionnaires."
15831234|NCT04194840|Other|Patient follow-up questionnaire|"Patient follow-up questionnaire:
~Questionnaire to learn more about participant opinions concerning the clinic and the quality of care received during visits with specialists"
15831235|NCT04194827|Diagnostic Test|Adalimumab serum trough concentration|Dose reduction based on adalimumab serum trough concentration
15831236|NCT04194827|Diagnostic Test|Disease activity|Dose reduction based on adalimumab diseas activity
15831237|NCT04194827|Drug|Adalimumab|Adalimumab
15831238|NCT04194814|Drug|crisaborole (2%) ointment|twice daily application on one forearm for 4 weeks (randomised site allocation)
15831239|NCT04194814|Drug|betamethasone valerate 0.1% cream|twice daily application on one forearm for 4 weeks (randomised site allocation)
15831240|NCT04194801|Drug|Fisogatinib in combination with CS1001|During the treatment period, the subjects will be administered the study drug once every 21 days (3 cycles). Fisogatinib is taken orally (PO) once daily (QD); CS1001 is administered intravenously once every 21 days (Q3W).
15831241|NCT04194775|Drug|CS1003+Lenvatinib|CS1003, intravenous (i.v.) administration every 21 days; Lenvatinib oral administration, once daily
15831242|NCT04194775|Drug|CS1003 Placebo+Lenvatinib|CS1003 Placebo, i.v. administration every 21 days ; Lenvatinib oral administration, once daily
15831243|NCT04194762|Other|Non pharmacological therapy|treadmill training and cycling training in equal intensity exercise.
15831244|NCT04194749|Other|Digital Media Based Physical Therapy|This intervention is a modified post immobilization protocol. This will include giving the patients a USB drive loaded with a 12 week therapy protocol presented in digital form with videos and graphical representations of exercises to be done. They will also have access to the videos and multimedia on the Oregon Health & Science University website.
15831245|NCT04194749|Other|Traditional Physical Therapy|This intervention is a 12 week therapist supervised clinic-based therapy protocol.
15831246|NCT04194736|Other|Ultrasound scan|"First ultrasound scan from 1 day to 6 days after the placement of the percutaneous central venous catheter.
~Second ultrasound scan from 7 days to 13 days after the placement of the percutaneous central venous catheter if no thrombosis was detected at the first ultrasound scan."
15831247|NCT04194723|Procedure|Antireflux Mucosectomy|ARMS aimed at resection of mucosa at gastric cardia to induce fibrosis and tighten the gastroesophageal junction and reduce acid reflux
15831248|NCT04194710|Biological|Autologous Cytokine Rich Serum|"Proteins, called cytokines, released from blood platelets and leukocytes, play an important role in the repair and regeneration of the injured tissue that causes lateral epicondylitis.
~Autologous Cytokine Rich Serum is prepared by the medical devise Q-Cytokine (CE MED31489) from patient's blood. The company Tecnologia Regenerativa Qrem S.L., with licence number 7096-PS from Agencia Española de Medicamentos y Productos Sanitarios (AEMPS), is the manufacturer of this product. Q-Cytokine is a lab-in-a-box devise, and consist of an automatic centrifuge and a sterile disposable kit. After 9 steps of centrifugation, that take place in 36 minutes, Cytokine Rich Serum is obtained. This Cytokine Rich Serum is then injected to the epicondyle.
~Patients randomized to this treatment will receive 1 injections of Autologous Cytokine Rich Serum right after randomization and another one after 15 days.
~This process will take place at outpatient clinics."
15831249|NCT04194710|Procedure|Arthroscopic Resection|"Surgical treatment of resection by arthroscopy is the standard treatment for chronic epicondylitis. The surgery is performed in the operating room under local anesthesia and lasts approximately 30 minutes. During the surgery, the doctor accesses the tendon by arthroscopy to perform an exeresis of the degenerated tendon. After the operation, the patient is directed to the recovery room where the responsible doctor will perform a physical examination and examination before leaving the center.
~This process will take place at the major ambulatory surgery center of the investigator's hospital."
15831250|NCT04194697|Behavioral|Exercise|Exercise program
15831251|NCT04194697|Behavioral|No exercise|No exercise program
15831252|NCT04194684|Drug|nab-paclitaxel|nab-paclitaxel 125mg / m2, intravenous drip 30min, d1, 8, 21 days as a cycle, until the disease progresses or intolerable toxicity. According to the calculation results, the administered dose can be within ± 10% of the calculated dose.
15831255|NCT04194658|Drug|Letrozole 2.5mg|Pretreatment letrozole 12.5 mg for 2 days prior to misoprostol.
15831256|NCT04194645|Drug|BI 474121|Single dose
15831257|NCT04194645|Drug|Placebo|Single dose
15831258|NCT04194632|Procedure|Temporary right ventricular pacing|As described previously. Patients will undergo temporary pacing at the site of latest endocardial activation with measurement of hemodynamic effects.
15831259|NCT04194619|Other|Questionnaire|Interview of women with a rare vascular disease through a phone questionnaire about severe and specific obstetrical complications during and after pregnancy.
15831260|NCT04194606|Procedure|Use of radial artery for access for a coronary angiography or intervention|After puncture of the radial artery in either the area of the anatomical snuffbox or the lower forearm following modified Seldinger technique a sheath will be advanced and a CAG or PCI will be performed. After the procedure is finished the sheath will be withdrawn and a standard closure device will be applied to achieve hemostasis. The choice of the patients side, the sheath, the catheters and the closing device will be at the discretion of the interventionalist.
15831261|NCT04194593|Other|PCR (Polymerase Chain Reaction)|"Biological testing of FFPE (Formalin-Fixed Paraffin-Embedded) or frozen samples of tumors will be led. These tissues have been collected during the treatment of patients (for diagnostic purposes).
~A molecular analysis (polymerase chain reaction) is led on DNA extracted from FFPE/frozen conserved tissues, and a result is produced by the algorithm."
15831262|NCT04194580|Behavioral|Phisical activity intervention|The prevalence of overweight in chilean children in the among the highest in the world and increasing quickly. The investigators recently evaluated an after-school program of recreational physical activity to control overweight, obesity and other cardiovascular risk factors in primary school children Temuco. This program reduced adiposity and increased the fitness.
15831263|NCT04194567|Other|Black Ragi|Pancakes made out of the dark ragi
15831264|NCT04194567|Other|White Ragi|Pancakes made out of the white ragi
15831265|NCT04194554|Drug|Niraparib|given PO per dose escalation schedule
15831266|NCT04194554|Drug|Leuprolide|22.5 mg q3 month
15831267|NCT04194554|Drug|Abiraterone Acetate|1000 mg daily
15831268|NCT04194554|Radiation|Stereotactic body radiotherapy (SBRT)|5-6 fraction SBRT (total dose: 37.5-40 Gy)
15831269|NCT04194541|Device|Cutimed Sorbact Hydroactive B wound dressing|Wound dressing applied and changed as needed.
15831270|NCT04194541|Device|Cutimed Siltect wound dressing|Wound dressing applied and changed as needed.
15831271|NCT04194541|Device|Sorbion Sana multi-star wound dressing|Wound dressing applied and changed as needed.
15831272|NCT04194528|Drug|Oxycodone/acetaminophen 5/325 mg|The intervention is the Proteus digital medicine program consisting of a mobile application, a patch worn on the body, and oxycodone/acetaminophen 5/325 mg co-encapsulated with ingestible sensors. The duration of the intervention is 6 weeks.
15831273|NCT04194528|Device|Proteus digital medicine program|The intervention is the Proteus digital medicine program consisting of a mobile application, a patch worn on the body, and oxycodone/acetaminophen 5/325 mg co-encapsulated with ingestible sensors. The duration of the intervention is 6 weeks.
15831276|NCT04194502|Diagnostic Test|Transesophageal echocardiogram (TEE)|All patients enrolled in the study will undergo a pre-operative research TEE and an intra-operative clinical TEE.
15831277|NCT04194489|Other|FMF Connect|The FMF Connect intervention includes cloud infrastructure and an innovative, multilayered mobile app. It incorporates tailored content for parents/caregivers of children (ages 3-12) with FASD or PAE. The app integrates five main components: 1) Dashboard; 2) Learning Modules; 3) Family Forum; 4) Library; and 5) Notebook. Weekly emails are also sent to support motivational engagement.
15831278|NCT04194476|Diagnostic Test|StatStrip blood glucose meter and strips|We'll use a drop of heel-stick blood to test blood glucose on the glucose meter. About 200-300 ul of blood from the same stick site will be collected, centrifuged to get plasma for testing of glucose level in a laboratory biochemistry analyzer.
15831279|NCT04194463|Other|ChemoFit exercise prehabilitation intervention|Exercise intervention consists of walking monitored by wearing a pedometer device. After a baseline measurement of participant's walking activity is done, increase in step count from baseline step count is prescribed. This increase in step count is achieved by walking or jogging at moderate intensity for a target of 30 minutes per day, each day. Participants are also encouraged to perform other physical if they wish and are able to. Patients are regularly contacted by a member of the research team on a weekly basis and given an option to maintain or to increase their step count further. The same approach is used after each week of the intervention. Strengthening exercises will form a further part of the exercise intervention. They are performed every day, 7 days a week. Patients are supplied with resistance bands with handles. They are educated on how to perform two repetitions of 5 simple exercises, each for 1 minute duration.
15831280|NCT04194450|Dietary Supplement|Ketone monoester|Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior to assessment of outcomes.
15831281|NCT04194450|Dietary Supplement|Placebo|Acute ingestion of taste-matched placebo prior to assessment of outcomes.
15831282|NCT04194437|Device|OCS Liver System|The OCS Liver System will be used to preserve, optimize and assess livers from DCD donors.
15831283|NCT04194424|Other|Multidisciplinary weight loss program|Diet and behavioral therapy,and supervised exercise sessions
15831284|NCT04194424|Other|Standard Care|General lifestyle tips
15831285|NCT04194424|Drug|Metformin Hcl 850Mg Tab|1 tablet, twice daily
15831286|NCT04194398|Device|OCS Lung System|Patients previously transplanted with lungs preserved on the OCS Lung System in the Expand Lung study.
15831287|NCT04194385|Procedure|Upper trunk block|Block will be applied to supraclavicular zone by 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine .
15831288|NCT04194385|Procedure|Costoclavicular block|Block will be applied to infraclavicular zone by 20 ml % 0.25 bupivacaine with 5 mcg/ml epinephrine.
15831289|NCT04194385|Procedure|Diaphragmatic function assessment|Diaphragmatic excursion will be assessed under ultrasound immediately before and after regional anesthesia.
15831290|NCT04194385|Procedure|Cervical plexus blockade|Block will be applied at thyroid cartilage level via 10 ml % 0.25 bupivacaine.
15831291|NCT04194359|Drug|sintilimab injection|Sintilimab Injection: 200 mg, i.v., D1, Q3W, 8 courses
15831292|NCT04194359|Drug|Control Test|XELOX + Bevacizumab
15831293|NCT04194346|Procedure|Lung ultrasound|Healthy volunteers will have lung ultrasonography at 4 predetermined sites for a set of 5 inspired volumes. For each volume, 3 respiratory cycles will be recorded.
15831294|NCT04194333|Procedure|Cone Beam CT with Embo Guide to creat 3D Overlay and CT Augmented Fluoroscopy to guide Electromagnetic Navigational Bronchoscopy instead of Standard Fluroscopic guidance using the C-Arm|Instead of the standard fluoroscopy using the C-arm, the intervention will undergo electromagnetic navigation guided bronchoscopy while using Cone Beam CT with Embo Guide to creat 3D Overlay and CT Augmented Fluoroscopy.
15831295|NCT04194320|Procedure|Ultrasound (US) guided supraclavicular brachial plexus block|Using 8 mg dexamethasone or 10 mg nalbuphine as adjuvants to (Lidocaine 2% + bupivacaine 0.5% 1:1 mixture) in ultrasound (US) guided supraclavicular brachial plexus block
15831296|NCT04194294|Drug|Lidocaine|Before induction of anesthesia; children in group LID received an iv bolus dose of LIDOCAINE 1 mg/kg over 5 minutes followed by 1 mg Kg-1 h-1 ivi until the start of skin closure.
15831297|NCT04194294|Other|Na CL 0.9%|Before induction of anesthesia; children in group C equivalent volumes of Na Cl 0.9% over the same period instead of LIDOCAINE.
15831298|NCT04194281|Other|Action Observation Training [AOT]|Parents are instructed to show their child repetitive arm, hand and finger movements in a playful and age-appropriate way for about 20 minutes a day, divided into several short sequences. AOT is to be carried out for four weeks at home by the parents and, if necessary, other caregivers. The parents receive instructions which contain background information on the possible importance of AOT for improving the functions of the upper limb, information about positions, promoting motivation, attention and interest as well as tips for promoting movement observation in everyday life.
15831299|NCT04194268|Radiation|Carbon Ion|12 x 4 Gy (RBE)
15831300|NCT04194255|Dietary Supplement|ferrous fumarate|iron (100 mg) supplement in form of ferrous fumarate
15831301|NCT04194255|Dietary Supplement|ferrous fumarate + 15 g GOS|iron (100 mg) supplement in form of ferrous fumarate with addition of prebiotics (15 g GOS)
15831302|NCT04194255|Dietary Supplement|ferrous fumarate + 15 g FOS|iron (100 mg) supplement in form of ferrous fumarate with addition of prebiotics (15 g FOS)
15831303|NCT04194255|Dietary Supplement|labelled iron as ferrous fumarate + 15 g acacia gum|iron (100 mg) supplement in form of ferrous fumarate with addition of prebiotics (15 g acacia gum)
15831304|NCT04194242|Drug|HEC96719 tablets|0.1、0.2、0.5、1、2、3、4 mg HEC96719 tablet in day1
15831305|NCT04194242|Drug|Placebo tablet|0.1、0.2、0.5、1、2、3、4 mg Placebo tablet in day1
15831306|NCT04194216|Drug|"Intra-operative single intravenous(iv) dose of cephalexin 2 g or clindamycin 900 mg."|Treatment Arm A
15831307|NCT04194216|Drug|"Intra-operative single dose (iv) of cephalexin 2 g or clindamycin 900 mg and postoperative oral dose of cephalexin 250mg (every 4 hours) or clindamycin 150mg(every 6 hours) for 3 days"|Treatment Arm B
15831308|NCT04194203|Drug|Atezolizumab|Atezolizumab will be administered by IV infusion at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit.
15831309|NCT04194203|Drug|Placebo|Placebo matching to atezolizumab will be administered by IV infusion at a fixed dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit.
15831310|NCT04194203|Drug|Bevacizumab|Bevacizumab will be administered by IV infusion at a dose of 15 mg/kg on Day 1 of each 21-day cycle.
15831311|NCT04194203|Drug|Paclitaxel|Paclitaxel will be administered by IV infusion at a dose of 175 mg/m2.
15831312|NCT04194203|Drug|Pemetrexed|Pemetrexed will be administered by IV infusion at a dose of 500 mg/m2.
15831313|NCT04194203|Drug|Carboplatin|Carboplatin will be administered by IV infusion to achieve an initial target AUC of 6 mg/mL/min.
15831314|NCT04194190|Drug|Individual Patient TCR-Transduced PBL|
15831315|NCT04194177|Other|mechanical ventilation during robotic surgery|protective ventilation PEEP= 6 cmh2o TV= 6 ml/kg conventional PEEP=2 cmH2O and TV=9 ml/kg
15831316|NCT04194164|Other|Fluid intake app|Monitor fluid intake and interdialytic weight gain in patients using the fluid app
15831317|NCT04194151|Drug|Propofol Injection|1, 1.5 or 2 mg/kg of propofol according to the subgroup
15831318|NCT04194138|Procedure|Index or spine revision surgery for complex adult spinal deformity|Surgical interventions will be patient specified by treating surgeon.
15831319|NCT04194125|Drug|177Lu-DOTATOC|Four administrations of 5,55GBq up to 7,4 GBq 177Lu-DOTATOC will be administered at 8-week intervals.
15831320|NCT04194112|Diagnostic Test|immediate urine cytology|Forty-eight hours after primary TURBT, IUC was retrieved and patients were scheduled for repeat TURBT 2 to 6 weeks later according to the predetermined protocol. The primary outcome was to determine the role of positive IUC to predict positive biopsy findings on repeat TURBT.
15831321|NCT04194099|Device|20 Hz rTMS (Brain)|Higher frequency (>5 Hz) trains increase cortical excitability.
15831322|NCT04194099|Device|iTBS rTMS (Brain)|Intermittent theta burst stimulation (iTBS) is a newer rTMS approach.
15831323|NCT04194099|Device|Anode tsDCS (Spinal)|Anodal tsDCS increased the spinal reflex amplitude, as well as corticospinal excitability.
15831324|NCT04194099|Device|20 Hz current square-wave pulses (Spinal)|Higher frequency (>5 Hz) of current increase cortical excitability.
15831325|NCT04194099|Device|iTBS (Spinal)|Intermittent theta-burst stimulation (iTBS) is a newer approach. it may increase corticospinal excitability.
15831326|NCT04194099|Device|sham|with sham stimulation on brain and spinal.
15831327|NCT04194086|Drug|posaconazole oral suspensions|posaconazole oral suspensions（5mg/kg/d,tid) will be administered specially febrile neutropenia patients four times a day and blood samples will be taken any hours after the first dose at least Day 7.
15831328|NCT04194073|Device|Pulse oximeter calibration population (NightOwl)|The NightOwl is a finger and/or forehead mounted device with, among other functions, the capability to acquire double-wavelength PPG, from which SpO2 can be derived
15831329|NCT04194060|Combination Product|Enhanced Recovery after Surgery group|"Tracheal intubation and with General anesthesia
~Short acting anesthetic agents,avoid opioid agents
~Omental patch repair with placement of sub hepatic drain
~Bilateral Transverse abdominis plane block/ Rectus sheath block immediately after surgery.
~Post operative nausea and vomiting prophylaxis.
~Encourage to mobilize out of bed after effect of general anesthesia has weaned off.
~Initiation of feeding-Oral sips on day 1, step up day 2 onward
~Removal of nasogastric tube-immediately after surgery after aspirating the gastric content through nasogastric tube.
~Removal of urinary catheter-after weaning from the effect of general anesthesia.
~Sub hepatic drain removal -anytime within 24 hours;drain will not be removed if fluid is bilious or pus.
~Avoid opiod analgesics."
15831330|NCT04194060|Combination Product|Conventional|"Tracheal intubation
~Short acting anesthetic agents, avoid opiod anesthesia agents.
~Omental patch repair along with sub hepatic drain placement.
~Post operative nausea and vomiting prophylaxis.
~Ambulation-as per patients' own request.
~Initiation of oral feed- after passage of 1st flatus.
~Nasogastric tube removal-output <300ml/day with resolution of ileus.
~Removal of urinary catheter- when patient sits on bed side/ambulate.
~Removal of sub hepatic drain-when patient tolerates unrestricted amount of liquid diet and drain output is less than 200 ml /day.
~Patient will receive opiod analgesics."
15831331|NCT04194047|Other|Transfusion|RBC transfusion (1 unit)
15831332|NCT04194047|Other|Crystalloids infusion|Infusion of 500 ml of balanced crystalloids
15831333|NCT04194034|Biological|TG6002|"Phase I part: Dose escalation from 1 x 10E6 PFU to 1 x 10E9 PFU. Phase II part: Established recommended Phase II dose (RP2D).
~Intrahepatic arterial (IHA) administration on Day 1 within a 14-day cycle of TG6002/5-FC combination treatment.
~A second cycle of TG6002/5-FC combination starting with TG6002 (IHA) administration at the same dose on Day43 can be initiated if no progressive disease or Dose Limiting Toxicity event in between; maximum 2 cycles of TG6002/5-FC combination treatment for each patient."
15831334|NCT04194034|Drug|Flucytosine (5-FC)|"Oral administration 4 times per day at the total dose of 200 mg/kg/day for 10 consecutive days per 14-day cycle of TG6002/5-FC combination.
~A second cycle of TG6002/5-FC combination will be initiated if no progressive disease or Dose Limiting Toxicity event in between."
15831335|NCT04194008|Device|Nerivio|A remote electrical neuromodulation (REN) device for the acute treatment of migraines.The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application.
15831336|NCT04193995|Behavioral|Intermittent fasting|There are two 36h fasting periods (FP) every week, over a 12week period. Free access to water is allowed; two cups of tea or coffee are also allowed. Each 36h FP begins after the last meal, which is consumed no later than 2000h on the preceding nights. Fasting days are Sunday and Wednesday, and fasting is terminated at 0800 on Monday and Thursday. Medications may be adjusted as needed during these visits, and this is reconsidered and may be further adjusted after the receipt of the blood tests results later during the day. Adjustments based on lab results are discussed with the patients during the clinic visit or later on the same day. Also, dietary needs are addressed by the physician and /or the dietician, during the clinic visit. As of week 3 through week 12, clinic visit is reduced to once a week, on Thursdays.
15831337|NCT04193982|Drug|Saroglitazar|Patient receives Saraglitazar 4mg once daily
15831338|NCT04193982|Drug|Vitamin E|Patient receive Vitamin E 400mg twice daily after food for 6 months
15831339|NCT04193982|Drug|Combination drug|Patient receives Vitamine E 400mg twice daily and Saraglitazar 4 mg once daily for 6 months
15831340|NCT04193982|Behavioral|Lifestyle Changes|Patients receives dietary advise and does exercise in form of aerobic and targets 7 to 10 percent weight loss in 6 months
15831511|NCT04192474|Device|Flexible cystoscopy|Treatment with the investigational device: Ambu® aScope™ 4 Cysto
15831341|NCT04193969|Diagnostic Test|Pressure pain assessment using computer controlled cuff algometry|Pressure pain sensitivity is assessed. The pressure is gradually increased and pain is rated by the participant on an electronic visual analogue pain rating scale (VAS) which is connected to the equipment. The assessment is performed on the lower leg and the upper arm. The pain free leg and the left upper arm is used in the patient group. The leg used in the control group will be chosen in a balanced manner meaning that half will receive pressure on the left leg and the other half on the right leg. The pain detection threshold (PDT), pain pressure tolerance threshold (PPT) and pressure pain intensity perceived as 6 on the VAS (VAS6) at the leg site is registered. The PDT and PPT on the arm site is registered.
15831342|NCT04193969|Diagnostic Test|Temporal summation (TS)|10 repeated inflations on the lower leg with a 1 sec interval. The pressure used at each pressure is equivalent the PPT measured at baseline. Each inflation is rated on the VAS. TS is registered as the increase pain intensity.
15831343|NCT04193969|Diagnostic Test|Conditioned pain modulation (CPM)|The cuff on the upper arm is inflated until 70% of the PPT is reached. While the pressure on the arm is kept constant the cuff on the leg is inflated. PDT, PPT and VAS6 pressure at the leg site is registered during the tonic stimulation (pressure on the left arm). The procedure on the leg is repeated within 30 seconds after the pressure is released on the arm site.
15831344|NCT04193969|Diagnostic Test|Low back pain rating scale (LBPRS-pain)|A questionnaire measuring the intensities of low back pain and leg pain currently, on average the last two weeks and the worst pain within the same period.
15831345|NCT04193969|Diagnostic Test|Oswestry Disability Index|A questionnaire measuring the disability in relation to low back pain and leg pain.
15831346|NCT04193956|Other|Standard-of-care procedures|Patients receive standard of care anti-PD-1 treatment as monotherapy or in combination with other checkpoint inhibitors. Related assessments, as laboratory assessments, CT-thorax-abdomen and FDG-PET will be performed according to clinical routine procedures.
15831347|NCT04193956|Other|Study procedures|Patients will undergo tumor biopsies, venous blood sampling and feces sampling in combination with a food questionnaire before, during and at the end of standard of care anti-PD-1 treatment.
15831348|NCT04193930|Drug|Letrozole|Oral tablet letrozole 2,5 mg/twice daily for 5 days
15831349|NCT04193930|Drug|Menotropins|150 IU of highly purified menotropins intramuscular
15831350|NCT04193930|Drug|recombinant Follicular stimulating hormone|recombinant Follicular stimulating hormone 300- 400 IU
15831351|NCT04193917|Diagnostic Test|Conjunctival swab|A conjunctival swab of both eyes will be taken at the same time together with an extensive questionnaire.
15831352|NCT04193904|Drug|MRx0518|MRx0518 is a live biotherapeutic product consisting of a lyophilised formulation of a proprietary strain of bacterium. The study dosing regimen is one capsule two times per day for the duration of the treatment period.
15831353|NCT04193904|Radiation|Hypofractionated Preoperative Radiation|Radiation will be delivered as 30Gy/10 fractions over two weeks.
15831354|NCT04193891|Other|Modified Atkins Diet|The ketogenic diet, where individuals restrict their carbohydrate intake and significantly increase their intake of fats, was initially primarily used in children with severe epilepsy, often due to genetic syndromes. Recently, with the advent of slightly less restrictive forms of ketogenic dietary therapy (e.g. the modified Atkins diet), it has begun to be used in adults with intractable seizures who are not surgical candidates.
15831355|NCT04193878|Drug|Inhaled budesonide and formoterol|aerosolized doses of budesonide (1.0 mg/2 ml) and formoterol (20 mg/2 ml) twice daily for up to 5 days
15831356|NCT04193878|Drug|Inhaled placebo|aerosolized saline (4 ml of 0.9% saline) twice daily for up to 5 days
15831357|NCT04193852|Drug|Dienogest 2.0 mg and Ethinyl estradiol 0.03 mg Test Drug|Coated Tablets
15831358|NCT04193852|Drug|Dienogest 2.0 mg and Ethinyl estradiol 0.03 mg Reference Product|Coated Tablets
15831359|NCT04193839|Other|Computerized Provider Order Entry (CPOE) plus Bar Code Medication Administration (BCMA)|Computerized provider order entry (CPOE) refers to the process of providers entering and sending treatment instructions - including medication, laboratory, and radiology orders - via a computer application rather than paper, fax, or telephone. The bar Code Medication Administration (BCMA) is a system that consists of a bar code reader, a portable or desktop computer with wireless connection, a computer server, and some software. Before the administration of medications to the patients the patient unique barcode identification is scanned in order to verify the patient's identity.
15831360|NCT04193826|Device|Left Atrial Appendage Closure|Closure of the left atrial appendage (LAAC) is performed percutaneously. Implantation of the LAAC device will be performed according to device specific instructions for use based on both TEE guidance, ICE and angiography, femoral access and inter-atrial septum crossing
15831361|NCT04193813|Other|Observational|Observational study
15831362|NCT04193800|Other|10-week rotation in primary care setting|Ten paramedics underwent a 10 week rotation into a GP practice in the Leeds area of South Yorkshire, England.
15831363|NCT04193787|Other|EPIC-P|EPIC-P is a brief, bio-behavioral intervention based on the information-motivation-behavioral skills (IMB) model framework, which integrates i) a biomedical component (i.e., PrEP), ii) behavioral components (i.e., drug- and sex-related primary HIV prevention), and iii) mHealth technology (i.e., text messaging PrEP reminders).
15831364|NCT04193774|Diagnostic Test|Conjunctival swab|Swab of the conjunctival fornices of both eyes
15831365|NCT04193774|Drug|Oxybuprocaine Hydrochloride 0.4% Eye Drops|One drop of topical anesthesia in one eye
15831366|NCT04193774|Drug|artificial tears|One drop of artificial tears in the other eye
15831367|NCT04193761|Diagnostic Test|taurine level|Taurine: determined by High-Performance Liquid Chromatography according to the pre-column extraction and derivatization methodology of McMahon et al. in the present work we use the Shimadzu, Japan HPLC model LC-10 AT.
15831368|NCT04193748|Drug|Topical pomegranate seeds and peel extracts|Topical pomegranate seeds and peel extracts in the form of gel
15831369|NCT04193735|Diagnostic Test|MRI scans after a liquid meal|Participants will be scanned fasted, then receive a liquid meal, then be scanned every half hour, seven times
15831370|NCT04193722|Drug|Hyperbaric oxygen therapy|Hyperbaric oxygen therapy in a multiperson hyperbaric oxygen chamber. Standard hyperbaric oxygen therapy provided as reimbursed by insurers.
15831456|NCT04192968|Other|Cortical auditory evoked potentials|Recording of automated cortical auditory evoked potentials in response to a vocal stimulus.
15833062|NCT04180072|Drug|Bevacizumab|Bevacizumab 15 mg/kg IV on day 1 every 3 weeks
15831371|NCT04193709|Device|Spinal Cord Epidural Stimulation|For arm 2, optimal stimulation parameters (cathode/anode configuration, stimulation frequency and voltage; placement of electrode from L1 to S1) will be identified for blood pressure and bladder pressure to achieve a bladder capacity in the target normative range of 400-450 mLs. Spinal cord epidural stimulation will then be used in a controlled lab setting for the regulation of blood pressure and heart rate to maintain normative values (target systolic pressure of 110-120 mmHg) and bladder pressure below 10 cmH2O during bladder filling up to the targeted capacity (fill volume of 400 mLs).
15831372|NCT04193696|Drug|Radiation therapy and systemic anti-PD-1 immunotherapy for patients with advanced hepatocellular carcinoma|The treatment will be started within 1 week after being admitted into the trial. IMRT or SBRT are adopted , and dose of radiation: Dt-PGTV=40Gy/10fractions,Dt-PGTV=30Gy/10fractions,Dt-PGTV=20Gy/10fractions ,and so on.200mg/ of Carelizumab for injection will be given intravenously every 3 weeks for 5 times since the first day of radiotherapy until disease progression, or intolerable toxicity.
15831373|NCT04193683|Other|Myofascial Release Technique|Myofascial release technique will bi applied bottom of the feet, back of the legs and hamstrings in both extremities. The practitioner will decide how long she should stay in a region according to the feeling of releasing in the tissue. The technique will be applied to a region at least 3 times.
15831374|NCT04193683|Other|Sham-Ultrasound|Sham-ultrasound will be applied to back of legs and thighs in both extremities without pressure and all parameters of the ultrasound device except the timer will be closed.
15831375|NCT04193670|Other|Clinical examination|This is a classic dermatological clinical examination during a classic consultation
15831376|NCT04193670|Procedure|Biopsies|"2 skin biopsies on a lesion area selected according to the inclusion criteria (2 punchs of 4 mm) for each experimental group.
~The first half of whole cutaneous biopsies (n = 25) will be studied using biphotonic microscopy. This will be performed on whole biopsies in 3-D according to the protocol developed in the laboratory.
~The second half of whole skin biopsies (n = 25) will be studied using the technique of single-cell RNA seq.
~The skin controls skin-free subjects will be obtained from skin reduction surgery (abdominoplasty) to subjects who have agreed to the use of their skin sample."
15831377|NCT04193670|Other|Blood test|A blood test on a tube (2 tubes of 10 mL).An assay of specific IgE and the serum level of IL-4, IL-13 and IL-5 will be carried out by ELISA (Enzyme Linked ImmunoSorbent Assay) from the blood samples.The blood samples will be obtained through the French blood establishment from different donors who have given their consent.
15831378|NCT04193657|Other|Daily and weekly triggered symptom monitoring|Participants are invited to complete a daily questionnaire, a weekly questionnaire, and to track daily activity with an electronic activity tracker.
15831379|NCT04193644|Behavioral|Mindfulness and Self-Compassion focussed exercises during walking training|Mindfulness and Self-Compassion focussed exercises during walking training with moderate intensity
15831380|NCT04193644|Behavioral|Walking training|Walking training with moderate intensity
15831381|NCT04193631|Drug|Cannabidiol (CBD)|A single dose of Cannabidiol (CBD) when patients experience musculoskeletal pain in the trial.
15831382|NCT04193618|Procedure|Conservative surgery for placenta accretta|Uterine devasculrization and transverse compressing sutures before placental delivery
15831383|NCT04193605|Behavioral|Mindfulness|The traditional MBSR intervention consists of the following: (1) a series of eight weekly session of 2.5 to 3 hours; (2) a silent retreat during the sixth week; (3) daily home assignments including formal and informal mindfulness practices; and (4) didactic presentations on stress and the consequences of stress. We are culturally tailoring the intervention with the goal of maintain fidelity.
15831384|NCT04193592|Drug|Pirfenidone|Pirfenidone will be titrated over 14 days, as tolerated, to the full dose of 2403 mg per day, as follows: Days 1 - 7: one capsule TID; Days 8 - 14: two capsules TID; Days 15 to week 52: three capsules TID. Dose may be reduced to manage an adverse event.
15831385|NCT04193579|Behavioral|Language Treatment|Recording of a mother's voice reading a children's storybook.
15831386|NCT04193579|Behavioral|Control Treatment|Standard of Care
15831387|NCT04193566|Drug|Forxiga|"Forxiga®, dapagliflozin 10 mg film-coated tablet.
~For further information please refer to:
~https://www.ema.europa.eu/en/documents/product-information/forxiga-epar-product-information_en.pdf.
~Common side effects include hypoglycemia, hypotension, elevated hematocrite, dyslipidemia, back pain, dizziness, skin rash, urinary tract infection, vulvovaginitis and dehydration. Very rare incidents of ketoacidosis have been observed. Side effects have only been observed after use in longer periods and not in single-dose usage, as planned in the present study. A dose of 50 mg has been chosen to achieve optimal efficacy. Once-per-day doses of dapagliflozin for 12 weeks of 2.5 mg, 5 mg, 10 mg, 20 mg and 50 mg have been demonstrated to be relatively safe across the mentioned doses (20) and no apparent risk is expected from instituting two single-doses of 50 mg dapagliflozin."
15831388|NCT04193553|Drug|Lenvatinib|"Lenvatinib will be administered continuously but patient's follow-up visits will be scheduled monthly.
~The starting dose of study treatment is 24mg, once daily, at the same time. Recommendations for dose reductions will be respected according to BI Lenvatinib.
~If a patient misses a dose, and it cannot be taken within 12 hours, then that dose should be skipped and the next dose should be taken at the usual time of administration.
~Study treatments will be continued until a treatment discontinuation criteria is met."
15831389|NCT04193553|Drug|Placebo|"Placebo will be administered continuously but patient's follow-up visits will be scheduled monthly.
~The starting dose of study treatment is 24mg, once daily, at the same time. Recommendations for placebo dose reductions are the same as for Lenvatinib. If a patient misses a dose, and it cannot be taken within 12 hours, then that dose should be skipped and the next dose should be taken at the usual time of administration.
~Study treatments will be continued until a treatment discontinuation criteria is met.
~In case disease progression, patients in control arm could switch in the Lenvatinib + BSC arm."
15831390|NCT04193553|Other|Best supportive care|At any time during the study, patients should receive best supportive care. Best Supportive care as medically indicated for the patient's well-being may be prescribed at the investigator's discretion. Based on the patient's condition, it may consist (but not limited) of analgesics, antibiotics, steroids, blood transfusion, antiemetics, antidepressants/anxiolytics, nutritional counselling, psychological support, palliative radiotherapy…
15831391|NCT04193540|Other|ACE questionnaire|Regardless of the result of the ACE questionnaire, physician, resident and nurse in charge of the patient will be asked their clinical opinion on decision-making capacity of the patient, based on a 4 steps Lickert scale and blindly of ACE result.
15831392|NCT04193527|Drug|DaTSCAN™ Ioflupane (123I) Injection|All participants will receive a single IV injection of DaTSCAN™ ioflupane (123I) into an arm vein. The dose of DaTSCAN™ ioflupane (123I) administered will contain a total of 3 to 5 mCi (111 to 185 MBq) in a maximum volume of 5 mL for an individual participant.
15831393|NCT04193514|Other|Acceptance and Commitment Therapy|The intervention is a 7-day self-guided acceptance-based intervention using a published Acceptance and Commitment Therapy self-help work book. This therapy is based on the theory that rigid attempts to control internal states, thoughts and feelings, and other forms of experiential avoidance contribute to symptom development and maintenance of depression, anxiety and/or stress. The therapy includes two components: (a) educating patients about the exacerbation of stress and negative affect through rigid attempts at experiential avoidance, and (b) introducing acceptance and the willingness to experience pregnancy-related sensations and cognitions as an alternative to experiential control, through the practice of intentional and non-judgmental paying attention to one's thoughts, feelings, images and bodily sensations (including aversive symptoms) and learning to see thoughts as an ongoing process distinct from self rather than merely an event with literal meaning.
15831394|NCT04193501|Drug|Melatonin 3 mg|Melatonin dose: 3mg/OD Melatonin is a hormone made by the pineal gland; its biosynthesis is initiated by the uptake of the essential amino acid tryptophan and is an important inducer of sleep. Abnormality in melatonin has been shown in several studies on patients of IBS and functional constipation.
15831395|NCT04193501|Other|Placebo|Similar looking placebo
15831396|NCT04193488|Behavioral|MTP block|In the MTP Group, a high frequency HFL-50 15-6 MHz linear ultrasound probe will be placed vertically approximately 3 cm laterally from the midpoint of the incision line in the midline. Using the parasagital scan, the block needle (50 mm 22 Gauge) will be advanced from the caudal to the cervical target of the paravertebral space. When the needle tip reaches the midpoint between the transverse process and the pleura, 1 ml saline is performed. Once the needle tip has been confirmed, 20 ml of 0.25% bupivacaine will be given to the block. The same procedure will be applied 3 cm later than the incision line.
15831397|NCT04193488|Behavioral|ESP block|In the ESP group, a high-frequency 15-6 megahertz linear ultrasound probe will be placed vertically approximately 3 cm laterally from the midpoint of the incision line in the midline. Once the erector spinae muscle and transver projections have been identified, the peripheral nerve blockage needle (50 mm 22 Gauge) will be advanced from caudal to cranial between the fascia of the erector spina muscle and the transverse process. After 1 ml saline injection, this plane will open. Twenty milliliters of 0.25% bupivacaine will be given for the block. The same procedure will be applied from the other 3 cm lateral of the incision line.
15831398|NCT04193488|Behavioral|No Block group|No regional plan block will be applied to the control group. Conventional analgesic methods were applied.
15831399|NCT04193475|Other|Analysis|No intervention planned. Novel analysis of echocardiographic data.
15831400|NCT04193462|Other|Post-partum depression- Dyadic psychotherapy-|Mothers and infants will be treated with dyadic psychotherapy focused on interactions, emphasizing eye contact, body language, empathy, and social reciprocity. Dyadic psychotherapy will be administered one time a week during the 8-week trial period, at the subject's home. Each session, approximately 90 minutes long, will include videotaping mother-infant interaction, watching the last session's interaction as a part of video-feedback technique, and discussing main issues in the mother-infant relationship. In addition, each session will begin and end with a- 5-minute episode of affectionate touch and gaze synchrony between the mother and her infant. During the whole therapy-trial, the therapist will also use cognitive-behavioral approach to address the mother's perception of her infant and of herself as a mother.
15831401|NCT04193462|Other|Post-partum depression- Psycho-educational therapy|Mothers will receive a therapy in their homes for 8 weeks, 1.5 hours for each session by a therapist arriving at their home. Each session will address a different developmental aspects of the baby (feeding, movement, social-emotional development etc.). Therapist will ask the mother about her baby, will give information about developmental needs and expectations and will help mother to enrich child's development and deal will potential problems
15831402|NCT04193449|Diagnostic Test|colonoscopy|colonoscopy procedure
15831403|NCT04193436|Drug|PF-06835919 25 mg|PF-06835919 in 25 mg oral tablet will be administered on Day 1
15831404|NCT04193423|Other|Neck extensors training versus deep cervical flexors training, compared to a control group.|"During the first month, the participants of the experimental groups will come at Rehabilitation Service to do the exercises individually and supervised by the physiotherapist and to received the conventional treatment (10 minutes of infrared heat, 10 minutes of massage and 15 minutes of TENS). The last six months, they will perform daily home exercises.
~A-group: the degrees respect to the floor in wich each participant can hold the craniocervical extension and the cervicothoracic extension during 5 seconds will bo measured with the BDI.
~B-group: Using an air-filled pressure sensor placed behind the neck, the physiotherapist will identify the target level that the patient can hold steadily a craniocervical flexion (CCF) for 5 seconds in a controlled manner. They will train following the protocol described by Jull et al.
~Of each of this exercises, they will perform 10 isometric contractions, at the corresponding degrees or target level, of 10 seconds with a rest of 3-5 seconds."
15831405|NCT04193410|Behavioral|Various health-promoting initiatives|No intervention is allocated in this study other than activities planned by childcare centres in accordance with wishes and needs of childcare centre staff and parents.
15831406|NCT04193397|Other|Physical exercise|The post-bariatric patients will perform a physical exercise program (aerobic and resistance), three times a week for six months
15831407|NCT04193371|Other|Active acupuncture|The rationale of the active acupuncture protocol is based on Western Medical Acupuncture theories and follows CONSORT and STRICTA protocols. All patients received acupuncture treatment for 30 minutes three times a week, with a maximum of 48 acupuncture treatments.
15831408|NCT04193371|Other|Control acupuncture|In the control acupuncture protocol, 2 needles were inserted superficially to a depth of less than 5 mm, 1 in each shoulder and 1 in each upper arm at nonacupuncture and non-meridian points, and then, 4 needles were attached to electrodes and the stimulator was turned on to mimic the active acupuncture but with zero intensity, no electrical stimulation. They also received the treatment for 30 minutes three times a week and a maximum of 48 treatments.
15831506|NCT04192539|Diagnostic Test|Taurine|Serum taurine was determined by High Performance Liquid Chromatography (HPLC) according to the pre-column extraction and derivatization methodology of McMahon et al. In the present work, we use Shimadzu HPLC model LC-10AT
15831409|NCT04193371|Other|Lifestyle management|"All women will receive lifestyle management before randomization after baseline measurements. The lifestyle management assisted by a PCOS lifestyle management system (Invention patent, ZL 2015 1 0500978.9).
~All participants will get a step-counter for daily use and physical exercise diary for daily reporting of exercise: number of steps, type of activity, intensity and time (minutes). Once a week each participant receive a SMS in which they report the activity during the week."
15831410|NCT04193358|Dietary Supplement|FERTILIS HOMME®|L-carnitine 220 mg, Zinc 20 mg, Selenium 0.03 mg, L-arginine 125 mg, L-glutathione 40 mg, Folic acid (vitamin B-9) 0.4 mg, Coenzyme Q10 7.5 mg, and Vitamin E 60 mg
15831411|NCT04193358|Other|PLACEBO|Sugar pills
15831412|NCT04193345|Other|Documentation of Maternal blood loss and neonatal outcome|Comparing and monitoring the maternal blood loss and neonatal effect of delayed umbilical cord clamping and early umbilical cord clamping after delivery of the baby durin cesarean delivery in severe preeclampsia
15831413|NCT04193332|Device|NIR optical imaging camera|NIR optical imaging assisted identification of parathyroid glands during thyroid surgery using parathyroid gland autofluorescense
15831414|NCT04193319|Drug|Fluzoparib|PARP inhibitor
15831415|NCT04193319|Drug|Fluconazole|inhibitor
15831416|NCT04193306|Drug|Alirocumab|Alirocumab 150 mg s.c. every 2 weeks
15831417|NCT04193306|Other|Placebo|Placebo s.c. every 2 weeks
15831418|NCT04193293|Drug|duvelisib|PI3K Inhibitor
15831419|NCT04193293|Biological|pembrolizumab|Immunotherapy (PD-1 inhibitor)
15831420|NCT04193267|Device|MagStim Rapid2 Transcranial Magnetic Simulation|A non-invasive method of brain stimulation
15831421|NCT04193241|Procedure|Closure of chest tube wound|At the time of chest tube removal, the chest tube site or thoracostomy wound will be closed in such a way as to prevent an iatrogenic pneumothorax or contamination of the pleural space
15831422|NCT04193228|Device|Carbon Fibre Ankle Foot Orthosis|Off teh shelf carbon fibre ankle foot orthoses worn bilaterally
15831423|NCT04193228|Behavioral|Exercise|Ankle muscle strength training
15831424|NCT04193215|Biological|V114|IM injection
15831425|NCT04193215|Other|Pediatric vaccines|Standard of care vaccines administered according to the local recommended schedule.
15831426|NCT04193202|Drug|Gefapixant|Administered twice daily as an oral tablet of 45 mg
15831427|NCT04193202|Drug|Placebo|Administered twice daily as a placebo oral tablet matching gefapixant
15831428|NCT04193189|Biological|HEPLISAV-B|Administered by IM injection
15831429|NCT04193189|Biological|ENGERIX-B|Administered by IM injection
15831430|NCT04193176|Drug|Gefapixant|Administered twice daily as an oral tablet of 45 mg
15831431|NCT04193176|Drug|Placebo|Administered twice daily as a placebo oral tablet matching gefapixant
15831432|NCT04193163|Device|Hip prosthesis - ESOP 2 cementless femoral stem|ESOP 2 femoral stems are intended to be implanted in the femoral region during total hip arthroplasty in order to restore joint function.
15831433|NCT04193150|Diagnostic Test|Full pulmonary specialist assessment|Please see description for the intervention arm.
15831434|NCT04193137|Diagnostic Test|Oral sodium loading test,Seated saline infusion test and Captopril challenge test|"Oral sodium loading test : Patients received 6g oral sodium every day for 3 days.
~Seated saline infusion test: All participants received the infusion of 2 liters of 0.9% saline over 4 h in seated posture.
~Captopril challenge test: Patients received 50 mg captopril orally at 8-9 a.m. after sitting or standing for at least 2 h. Blood samples were drawn at time zero and 2 h after the challenge."
15831435|NCT04193124|Diagnostic Test|transcranial doppler.|Daily monitoring of transcranial doppler until the disappearance of the intracranial vasosparm
15831436|NCT04193111|Diagnostic Test|TMD pain screener|The danish TMD pain screener is given to all participants
15831437|NCT04193098|Biological|CTL|CTL injection
15831438|NCT04193098|Biological|Toripalimab|Toripalimab injection
15831439|NCT04193072|Behavioral|Assessment of imagery ability|Movement imagery, kinesthetic imagery, and visual imagery ability assessed.
15831440|NCT04193059|Drug|Paclitaxel|paclitaxel 80 mg/m^2 ivgtt d1, d8, d15, 28 days per cycle, 6 cycles.
15831441|NCT04193059|Drug|Carboplatin|carboplatin AUC=2 ivgtt d1, d8, d15, 28 days per cycle, 6 cycles.
15831442|NCT04193059|Drug|Epirubicin|epirubicin 90 mg/m^2 ivgtt d1, 21 days per cycle, 4 cycles.
15831443|NCT04193059|Drug|Cyclophosphamide|cyclophosphamide 600 mg/m^2 iv d1, 21 days per cycle, 4 cycles.
15831444|NCT04193059|Drug|Trastuzumab|trastuzumab 6 mg/kg (loading dose 8mg/kg) ivgtt d1, 21 days per cycle with chemotherapy; or trastuzumab 2 mg/kg (loading dose 4mg/kg, w1) ivgtt d1, d8, d15, d22, 28 days per cycle with chemotherapy. After chemotherapy, patient will continue to complete 1 year of adjuvant trastuzumab (6 mg/kg ivgtt every 3 weeks).
15831445|NCT04193059|Drug|Pertuzumab|pertuzumab 420mg (loading dose 840mg) ivgtt d1, 21 days per cycle with chemotherapy. After chemotherapy, patient will continue to complete 1 year of adjuvant pertuzumab (420mg ivgtt every 3 weeks).
15831446|NCT04193059|Drug|Docetaxel|docetaxel 100 mg/m^2 ivgtt d1, 21 days per cycle, 4 cycles.
15831448|NCT04193033|Other|FLOW intervention|The FLOW program, including internal and external facilitation, use of the FLOW online report to identify patients, patient and provider education materials, a medical record template, and regular data tracking and feedback about the process.
15831449|NCT04193020|Other|Surveillance card|Surveillance card and additional examination to find novel markers and better assess the existing ones
15831450|NCT04193007|Drug|molecular targeted therapies|if EGFR mutation is positive, (gefitinib, ecotinib, erlotinib）or ALK/ROS-1 positive（Crizotinib）
15831451|NCT04193007|Radiation|Brain Radiotherapy|SRS was used for 1-3 intracranial lesions, and simultaneous modulated accelerated radiation therapy for Brain(SMART-Brain)was used for more than 3 intracranial lesions
15831452|NCT04192994|Drug|Intravitreal Antibiotic Injection|Intravitreal Antibiotic Injection
15831453|NCT04192994|Procedure|Pars Plana Vitrectomy|Pars Plana Vitrectomy
15831454|NCT04192981|Drug|GDC-0084|GDC-0084 in 3 + 3 dose-escalation in 3 cohorts: 45, 60, 75 mg daily
15831455|NCT04192981|Radiation|whole brain radiation therapy radiation|30Gy in 10 fractions
15831457|NCT04192968|Other|Additional exams|"Cortical auditory evoked potentials Recording of automated cortical auditory evoked potentials in response to a vocal stimulus.
~Recording of cortical auditory evoked potentials in response to a click
~Realization of electrical potentials via the implant Followed up once a year during a visit scheduled for usual care, for 3 years, that to say up to 6 years post-implant."
15831458|NCT04192955|Drug|Acetyl Salicylate|Tablets
15831459|NCT04192942|Other|protocol of management of major burn in intensive care unit|primary assessment first aid management laboratory investigation radiological investigation surgical intervention
15831463|NCT04192916|Drug|DOACs|Direct Oral Anticoagulants
15831464|NCT04192903|Drug|Chidamide combined with Cisplatin|Chidamide: 30mg,PO,biw one week before cycle 1 treatment Cisplatin 75mg/m2 ivgtt D1 Chidamide :20mg PO Biw, 2 week on , 1 week off
15831465|NCT04192890|Device|Focal irreversible electroporation of the prostate cancer|Irreversible electroporation is a non-thermal tissue ablation technique in which short duration electrical fields are used to permanently permeabilize the cell membrane.
15831466|NCT04192877|Diagnostic Test|Vagus Nerve Neurodynamic test|The VN-NDT has been developed starting from the VN morphology selecting the physiological movements that induce the greater mechanical tension on the nerve. The subjects will be assessed supine on an examination table with assessors standing at the cranial short side of the table. Upper cervical flexion and contralateral lateral flexion had been selected for loading the intracranial portion. The ipsilateral neck rotation had been selected for loading the cervical tract. Keeping the subject's head in the final movements combination gentle movements of the upper abdomen caudally and cranially had been selected for loading the thoracic tract and used as discrimination maneuver. The test will be declared positive (indicating abnormal responses) if symptoms will be felt in anatomical regions other than the neck on the same side of the test and discrimination maneuvers changed the subject's symptoms indicating a neurogenic source, otherwise it will be declared negative.
15831467|NCT04192864|Procedure|Lingually based triangular flap|"A lingually based triangular flap was used to remove the impacted third molar. An incision was made adjacent to the distal surface of the mandibular second molar and extended along the sulcus to the distobuccal corner of the mandibular second molar, an oblique vestibular incision was made and extended into the vestibular fornix of the mandible. Aligned with the mesiobuccal cusp of the second molar.
~It was continued posterosuperior towards the anterior border of the mandibular ramus An incision will be made from the anterior border of the mandibular ramus to the distal surface of the mandibular second molar."
15831468|NCT04192864|Procedure|Buccally based triangular flap|The impacted teeth was removed using a buccal based triangular flap. It will be extended along the sulcus to the distobuccal corner of the second molar . The incision was continuous, with a relieving vertical incision, oblique into the mandibular vestibular fornix, aligned with the mesiobuccal cusp of the second molar.
15831469|NCT04192851|Procedure|Tent Pole Technique|"All patients were operated under local or general anaesthesia according to the case and patient tolerability.
~The oral cavity was prepared by 0.12% chlorhexidine mouthrinses solution* for thirty seconds.
~Full thickness incision down to the bone with blade no.15.
~A periosteal elevator was used to perform mucoperiosteal flap.
~Gentle elevation of the flap
~Fixation of the screws over the alveolar ridge with about 5 mm of the screw threads will be exposed
~Bone graft was mixed with the patient blood and placed to cover the screws completely.
~PRF membrane was be placed over the grafted sites.
~Repositioning of the flap and suturing with 3/0 black silk suture material"
15831470|NCT04192838|Procedure|Laparoscopic incisional ventral hernia repair|Laparoscopic repair of incisional ventral hernias (5-15 cm) with adouble-layer polypropylene- expanded polytetrafluoroethylene (ePTFE) mesh.
15831471|NCT04192838|Procedure|Open incisional ventral hernia repair|Standard polypropylene mesh was positioned as an inlay, or as an onlay over the external oblique fascia (i.e., subcutaneously), as preferred by the operating team. The mesh was fixed with absorbable stitches. Drains were usually placed.
15831472|NCT04192825|Procedure|surgical treatment|surgical drainage and/or surgical reconstruction procedures to anoperineal suppurations according to the doctor's decision
15831473|NCT04192812|Drug|PREOPERATİVE GnRHa THERAPY (LEUPROLIDE ACETATE) BEFORE SURGERY FOR UTERİN FIBROIDS|THE EFFICACY OF PREOPERATIVE USAGE OF GnRHa IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY DUE TO UTERIN FIBROIDS
15831474|NCT04192812|Drug|NO GnRHa|THE EFFICACY OF PREOPERATIVE USAGE OF GnRHa IN PATIENTS UNDERGOING TOTAL LAPAROSCOPIC HYSTERECTOMY DUE TO UTERIN FIBROIDS
15831475|NCT04192799|Behavioral|Direct admission|Process of pediatric admission is through admission directly into the pediatric hospital medicine unit
15831476|NCT04192799|Behavioral|ED admission|Process of pediatric admission is through the emergency department
15831477|NCT04192786|Other|Standard physiotherapy program+50 Hz local vibration|Standard physiotherapy program (strength, balance, gait exercises) for 50 minutes and local vibration applied to gastrocnemius (50 Hz) for 10 minutes will be performed 3 days a week for 8 weeks.
15831478|NCT04192786|Other|Standard physiotherapy program+100 Hz local vibration|Standard physiotherapy program (strength, balance, gait exercises) for 50 minutes and local vibration applied to gastrocnemius (100 Hz) for 10 minutes will be performed 3 days a week for 8 weeks.
15831479|NCT04192786|Other|Standard physiotherapy program|Standard physiotherapy program (strength, balance, gait exercises) for 60 minutes will be performed 3 days a week for 8 weeks.
15831480|NCT04192773|Drug|IV Lidocaine|Using IV lidocaine as intervention and comparing fMRI pre- and post-lidocaine infusion
15831481|NCT04192760|Procedure|Stenting|Comparison of two technical approaches in the interventional treatment on de-novo non-left main coronary lesions
15831482|NCT04192747|Device|Percutaneous Coronary Intervention|Percutaneous coronary intervention of de novo native coronary artery lesions
15831507|NCT04192513|Drug|J. lividum|Investigational Product
15831508|NCT04192500|Biological|OVX836|One single administration intramuscularly at Day 1.
15831509|NCT04192500|Biological|Quadrivalent seasonal influenza vaccine (Influvac TetraTM)|One single administration intramuscularly at Day 1.
15831680|NCT04191070|Device|infrazygomatic miniscrew|class II correction by distalization using infrazygomatic crest miniscrew
15831483|NCT04192721|Behavioral|Cognitive Behavioral Therapy-Based Group Counseling|"Relaxation techniques
~Providing personal development books
~Sharing the factors affecting the situation defined as depression (brainstorming)
~Explaining the link between depressive symptoms, thoughts, feelings, and behaviors
~Explaining automatic thoughts
~Application of relaxation techniques; deep-breathing exercises
~Identifying alternative thoughts
~Explaining the correlation between alternative thoughts and mood
~Introduction of the Automatic-Thought Registration Form and distribution to students
~Describing the effects of depression on social interaction
~Explaining activities that could be done individually and with the group
~Distribution of the activity list to students
~Description of ways of coping with stress
~Determination of individual stressors and their effects
~Planning for the future: preventing depression
~Discussion of assumptions/expectations about life
~Homeworks related to session contents"
15831484|NCT04192708|Procedure|intercostal nerve block under direct vision|When the intercostal nerve is adequated exposed，a surgeon use a 5ml syringe to perform the block and the needle is tilted 15 degree cephalad and advanced towards the caudal rim of the lib，and penetration depth is about 5mm.Then 1% lidocaine and 1/200000 epinephrine 3ml will be injected when negative aspiration of gas or blood.Same procedure will be repeted in the other two exposed intercostal spaces.
15831485|NCT04192708|Procedure|intercostal nerve block under ultrasound guidance|After induction ，an ultrasonographic probe (M-Turbo with the L25 transducer; SonoSite Inc.) is used to scan laterally from the midaxillary line to identify the required anatomic landmarks, while the patients are in a lateral decubitus position. The ribs are identified as hyperechoic streaks, while the pleura appeared as hyperechoic lines between and below the ribs.The needle was advanced towards the caudal rim of the rib until the distal tip is just between the innermost and inner intercostal muscle.1% lidocaine and 1/200000 epinephrine 3ml will be injected when negative aspiration of gas or blood.Same procedure will be repeted in the other two exposed intercostal spaces.
15831486|NCT04192708|Procedure|paravertebral block under ultrasound guidance|"Paravertebral block is performed between the thoracic segments T7-8,A linear ultrasound transducer (M-Turbo with the L25×transducer; SonoSite Inc.) is placed to parallel the T7 transverse process so as to identify the T7 spinous process，the T7 transverse process and 7th lib.Then move the probe caudally until the thoracic paravertebral space (TPVS) which is bounded by transverse process,pleura and internal intercostal membrane.Using in-plane technique, we advance the 20-gauge needle(Becton Dickinson Infusion Therapy Sysstems Inc.Sandy,Utah 84070,USA.1.88，1.1×48mm) until the needle tip penetrates the internal intercostal membrane,9ml mixture of 1% lidocaine and 1/200000 epinephrine after no blood or gas is aspirated.Both PVB and ultrasound-guided ICNB is performed by the same anesthesiologist"
15831487|NCT04192695|Device|Cytosponge cell collection device|The Cytosponge™ is a minimally-invasive sampling device consisting of a polyurethane sponge compressed in a cellophane capsule attached to a string. When swallowed, the capsule dissolves in the stomach, releasing the cell collection sponge that expands to 3 cm in diameter. Next, a nurse or qualified medical technician retrieves the sponge by pulling back on the string and retracting it through the mouth. During extraction, the rough texture on the surface of the sponge collects epithelial cells in the cardia and along the entire length of the esophagus. Cytosponge™ has excellent safety profile and is approved by the Food and Drug Administration (FDA) and the Healthcare Products Regulatory Agency (HPRA) in the UK.
15831488|NCT04192682|Drug|Anlotinib Hydrochloride|Anlotinib Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle, Combined With Sintilimab 200mg/time，21-day cycle。
15831489|NCT04192669|Device|Heart rate monitoring|The heart rate will be recorded and calculated by a heart rate monitor (Polar H10, Finland) located on the chest. The recording is done over a period of 5 minutes, the patient being in a sitting position, without any particular stimulus, in a quiet room. The recording is transferred via the HRV Logger application. Any ectopic beats and artifacts are automatically identified and replaced by values interpolated by the investigator, if necessary. The Kubios HRV Premium Software is used for all calculations.
15831490|NCT04192656|Device|non-invasive positive airway pressure|non-invasive positive airway pressure is the first-line treatment for obstructive sleep apnea
15831491|NCT04192656|Drug|Methylprednisolone Hemisuccinate|Methylprednisolone is the first-line treatment of idiopathic sudden sensorineural hearing loss
15831492|NCT04192656|Drug|Ginaton|ginnaton is ginkgo biloba extract
15831493|NCT04192643|Drug|Tranexamic Acid 100 MG/ML|1 GR TRANEXAMİC ACİD İN 100 ML SALİNE SOLUTİON GİVEN İN 15 MİNUTES
15831494|NCT04192643|Drug|Placebos|100 ML SALİNE SOLUTİON
15831495|NCT04192630|Device|CVisc50 OVD|CVisc50 OVD sterile solution will be injected into the anterior chamber per the schedule specified in the arm.
15831496|NCT04192630|Device|ProVisc OVD|ProVisc OVD sterile solution will be injected into the anterior chamber per the schedule specified in the arm.
15831497|NCT04192617|Drug|SM03|SM03: 600 mg intravenous (IV)
15831498|NCT04192617|Drug|Placebo|Placebo: 600 mg intravenous (IV)
15831499|NCT04192617|Drug|Methotrexate|methotrexate: 7.5-20 mg/week oral
15831500|NCT04192604|Other|WMSDsQ|Work-related MusculoSkeletal Disorders Questionnaire
15831501|NCT04192591|Device|Superion® IDS device|The Superion® IDS is a minimally-invasive spinal implant that treats LSS symptoms by limiting extension at the symptomatic level that compresses the neural elements and is designed for percutaneous surgical placement.
15831502|NCT04192578|Device|remote ischemic conditioning|RIC is induced by short-term insulting blood-flow of nonvital distant organs intermittently.
15831503|NCT04192565|Device|Robotic Endoluminal Resection|Robotic Resection of mucosal neoplasms in the colon and rectum using the ColubrisMX ELS system
15831504|NCT04192552|Other|PAUSE Perioperative DOAC Management|"Apixaban & Rivaroxaban: Hold DOAC for 2 days before procedure. Re-start DOAC 2+ days post-procedure.
~Dabigatran (see below):
~CrCl ≥50: Hold DOAC for 2 days before procedure. Re-start DOAC 2+ days post-procedure.
~CrCl <50: Hold DOAC for 4 days before procedure. Re-start DOAC 2+ days post-procedure."
15831505|NCT04192552|Other|ASRA Perioperative DOAC Management|"Apixaban & Rivaroxaban: Hold DOAC for 3 days before procedure. Re-start DOAC 1+ days post-procedure.
~Dabigatran (see below):
~CrCl >80: Hold DOAC for 3 days before procedure. Re-start DOAC 1+ days post-procedure.
~CrCl 50-80: Hold DOAC for 4 days before procedure. Re-start DOAC 1+ days post-procedure.
~CrCl 30-49: Hold DOAC for 5 days before procedure. Re-start DOAC 1+ days post-procedure.
~*Low-dose heparin bridging can be used if at high A-TE risk"
15831512|NCT04192461|Procedure|Tooth guided immediate implant placement|The technique of implant insertion consisted of a progressive preparation of the implant site using the anatomy of the root of the multi-radicular mandibular molars to be extracted as a reference and as an aid to engage the inter-radicular septum
15831513|NCT04192448|Other|Alcohol Administration|The clinical trial does not involve any treatment. Participant will be randomly assigned to receive alcohol (BAC = .08%) or water (BAC = .00%).
15831514|NCT04192448|Other|Mood Induction|The clinical trial does not involve any treatment. Participants will be randomly assigned to receive an anger emotion induction or a control (neutral) mood induction.
15831515|NCT04192435|Drug|Tranexamic Acid|100mg/ml
15831516|NCT04192435|Drug|Placebos|Placebo will be 5ml vials calculated to equivalent to the 100mg/ml of active drug.
15831517|NCT04192422|Other|no intervention|This is a cohort study no intervention
15831518|NCT04192409|Behavioral|Smartphone Application|Patients will use a smartphone application contain the following functions: providing health education information about DM and CAD, reminding patients to take medicine on time by alarm, recording patients' recent fast plasma glucose value.
15831519|NCT04192383|Radiation|Cyberknife stereotactic radiosurgery|Hypofractionated stereotactic radiosurgery
15831520|NCT04192370|Drug|Cannabidiol 600mg|All subjects will receive 600mg of oral cannabidiol for 3 days in an open-label fashion. Cannabidiol will be provided using Epidiolex™ oral solution 100mg/mL, and the drug will be procured by the Brigham and Women's Hospital (BWH) Investigational Drug Services (IDS) pharmacy. The first dose will be administered at the BWH Center for Clinical Investigation, while doses 2 and 3 will be self-administrated at home. The CBD will be repacked in pre-drawn syringes for the subjects to self-administer at home.
15831521|NCT04192357|Behavioral|M3F program|72-week behavioral weight loss program divided into three phases (first and second phase of weight loss, during 1 and 5 months, respectively; and a third phase of weight maintenance).
15831522|NCT04192357|Behavioral|Low-carb diet|72-week behavioral weight loss program divided in two phases (first of weight loss during 6 months and a second phase of weight maintenance).
15831523|NCT04192344|Drug|ABSK021|ABSK021 oral capsule
15831524|NCT04192331|Drug|nab-paclitaxel regimen1|nab-paclitaxel regimen1 means use abraxine with 125mg/m2 at day 1 and day 8 per 21d.
15831525|NCT04192331|Drug|nab-paclitaxel regimen2|nab-paclitaxel regimen2 means use abraxine with 125mg/m2 at day 1 and day 8 and day 15 per 28d.
15831526|NCT04192318|Behavioral|Bridging the Gap|Bridging the Gap is a hybrid model for violence prevention which integrates a hospital-based brief violence intervention (BVI) delivered to the patient while in hospital with a wrap-around community case management prevention strategy.
15831527|NCT04192318|Other|Communities that Care (CTC)|In CTC programs stakeholders elect evidence-based prevention strategies that are most appropriate for their community. These evidence-based strategies target their community's specific needs, such as reducing risk factors while supporting and increasing protective factors.
15831528|NCT04192318|Other|Treatment as usual|Treat and release
15831529|NCT04192305|Procedure|LPV|LPV means tidal volume of 6 ml/kg, inspiratory-expiratory (I/E) ratio of 1/1, positive end expiratory pressure (PEEP) minimum 5 cmH20 and higher during laparoscopy in obese patients, Inspiratory oxygen concentration (FIO2) 40 % during maintenance and extubation while also giving CPAP. Lung recruitment maneuver (LRM) when lung compliance decreases below 40 ml/cmH2O.
15831530|NCT04192305|Procedure|routine LV|Give volume en frequency as required by end tidal carbon dioxide, PEEP and LRM only when saturation drops intra operative, no requirement to use low FIO2 and CPAP during extubation.
15831531|NCT04192292|Drug|Sulfonylurea|Given at very low dose as a physiological stimulus on the beta cell not as medical treatment. 20mg gliclazide is being used in this study.
15831532|NCT04192292|Drug|DPP4 Inhibitor|Given as a physiological stimulus to augment endogenous incretin hormone levels, not as a medical treatment. 100mg sitagliptin is being used in this study.
15831533|NCT04192279|Diagnostic Test|lactate clearance|Lactate clearance rate was monitored within 6 hours after admission
15831534|NCT04192266|Drug|Estradiol|2.0 mg of estradiol will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions (Session 2- 6)
15831535|NCT04192266|Drug|Placebo oral tablet|2.0 mg placebo pills will be taken by mouth by the study participant 5-6 hours before each of 5 PE treatment sessions ( Sessions 2-6)
15831536|NCT04192253|Drug|Paclitaxel and Carboplatin|Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule
15831537|NCT04192240|Other|Training with external feedback|Sit to stand and stepping training with external feedback , after that subjects will be instructed to overground walking
15831538|NCT04192240|Other|Training without external feedback|Sit to stand and stepping training without external feedback, after that subjects will be instructed to overground walking
15831539|NCT04192227|Behavioral|EnHAncing BehavIors through wellness TreatmentS (HABITS)|Six 75-minute sessions via live video conference wherein participants will receive training in areas of health, wellness and quality of life. Classes will be supplemented with independent homework assignments and discussion on a closed social media forum with peers and facilitators.
15831540|NCT04192214|Drug|BC 007|1350 mg of BC 007
15831541|NCT04192162|Other|Mud therapy application|Aplication the mud pack therapy from 20 minutes
15831542|NCT04192162|Other|Sulfur water application|Aplication the sulfur water in bath from 20 minutes
15831543|NCT04192162|Other|Hygienic water|Exercise in hygienic water
15831544|NCT04192149|Other|Focused Ultrasound|Low intensity focused ultrasound is sound energy stimulation at a low intensity of 1-30 W/cm2
15831545|NCT04192136|Dietary Supplement|Nicotinamide Riboside|"Investigators will use (Good Manufacturing Process) GMP-grade 300 mg capsules of the dietary supplement nicotinamide riboside (ChromaDex, Irvine CA).
~NR is distributed by ChromaDex, Inc., Irvine, CA. NR is available as 300 mg capsules.
~The dietary supplement will be re-labeled by the Hospital of the University of Pennsylvania (HUP) Investigational Drug Service according to FDA regulations, including subject and physician name and NR or Placebo 300 mg capsules."
15831546|NCT04192136|Dietary Supplement|Placebo|The matched placebo will contain the same excipients without the active supplement and is generally recognized as safe. The placebo will be covered in an identical capsule (NR will be covered in the same capsule).
15831593|NCT04191694|Drug|Ondansetron 4 MG|Ondansetron 4mg intravenously, intra-operatively as part of standard hospital caesarean section protocol
15831547|NCT04192136|Other|Exercise Intervention|"The exercise program consists of at-home training sessions: 3 aerobic sessions per week on the in-home bike trainer, and 2 resistance exercise sessions per week using resistance bands.
~On aerobic training days, subjects will be given instruction on a recumbent Catrike trainer, titrated such that they spend 20 minutes at their target heart rate as determined by baseline Exercise Stress Test (EST) (60-80% of their heart rate at peak VO2) and as measured by their wearable device.
~On resistance training days, subjects will be given instructions to complete circuits of resistance exercises. Resistance training intensity (as determined by graded resistance bands) will be maintained at 60% of pre-training maximal voluntary contraction for each muscle group."
15831548|NCT04192123|Device|HM242|HM242-Solution and HM242-Gel will be topically applied in an occlusive patch for 48h on healthy skin on the subject's outer part of the upper arm.
15831549|NCT04192110|Drug|Diuretic initiation or augmentation|The participant's blood pressure medication regimen will then be altered to initiate a thiazide-type (hydrochlorothiazide or chlorthalidone) or loop diuretic (furosemide, bumetanide, or torsemide) in those not already prescribed a diuretic, or to increase the dose if one is already prescribed
15831550|NCT04192097|Other|Professionalism curriculum|"One year training program including ten two-hours sessions about
~Knowing yourself
~Interaction with patients and their families
~Teamwork and organization with colleagues"
15831551|NCT04192084|Procedure|microvascular partial toe transfer|we will perform microvascular partial toe transfer for patients with traumatic amputation of one or more digits
15831552|NCT04192071|Other|virtual technology - high interactive|Participants engage with web-based cancer prevention content and answer a short series of questions designed to assess their baseline risk for colon cancer and dietary intake. Interactive nutrition risk feedback will be customized based on user input.
15831553|NCT04192071|Other|virtual technology - low interactive|Participants engage with web-based cancer prevention content and answer a short series of questions designed to assess their baseline risk for colon cancer. Minimally interactive risk feedback will be delivered.
15831554|NCT04192071|Other|non-colorectal cancer related module|Participants engage with web-based content not related to colorectal cancer or nutrition.
15831555|NCT04192058|Device|Sham transcranial direct current stimulation (tDCS)|For sham treatment we will use the same assembly as the active ETCC. However, we will apply the current for 30s at the start of the stimulation session and 30s at the end of the session.
15831556|NCT04192058|Device|Active transcranial direct current stimulation (tDCS)|Transcranial direct current stimulation (tDCS) it is a therapeutic method that modulates membrane potential, where anodic stimuli induce cortical excitability and cathodic stimuli reduce it. The position of the electrodes will be performed based on a 10-20 system according to the international EEG unit system, with the location of the electrodes at C3 and F3, respectively. The anode will be positioned over the left hemisphere at C3 while the cathode will be positioned over the contralateral hemisphere F3. During active stimulation a 2.0mA current released by a 35 cm2 electrode will be used for 20 min.
15831558|NCT04192032|Other|Preferred Juul pod flavor (5% nicotine)|Preferred Juul pod flavor (5% nicotine)
15831559|NCT04192032|Other|Classic Tobacco Juul pod flavor (5% nicotine)|Classic Tobacco Juul pod flavor (5% nicotine)
15831560|NCT04192032|Other|Preferred flavor with HWL|Preferred flavor (5% nicotine) with HWL
15831561|NCT04192032|Other|Preferred flavor, 3% nicotine|Preferred flavor, 3% nicotine
15831562|NCT04192032|Other|Preferred flavor, 0% nicotine|Preferred flavor, 0% nicotine
15831563|NCT04192019|Drug|Micro-glucagon|Administration of 80 µg (micro-dose) subcutaneous Dasiglucagon 5 min before the start of exercise
15831564|NCT04192019|Drug|Mini-glucagon|Administration of 150 µg (mini-dose) subcutaneous Dasiglucagon 5 min before the start of exercise
15831565|NCT04192006|Device|Total Knee Arthroplasty|Surgical implantation of prosthetic knee using robotic-arm assist
15831566|NCT04191993|Device|Total hip arthroplasty|Surgical intervention designed to replace arthritic joint with artificial implant
15831567|NCT04191980|Other|Comparison of prostate multi-zone segmentation obtained with an automatic deep learning-based algorithm and two expert radiologists|"The algorithm is used to perform a multizone segmentation of the prostate including delineation of : the whole prostate contours, the transition zone contours, the anterior fibromuscular stroma.
~The contours is independently corrected by 2 radiologists. The corrected contours of the different zones will be stored and for each zone 6 different metrics will be used to evaluate the difference between the initial and corrected contours:
~Mean Mesh Distance: Average Boundary Distance (ABD) for each point of the reference segmentation. The distance to the closest point of the compared segmentation is first computed. Then the average of all these distances is computed and gives the ABD
~General Hausdorff distance (HD)
~95% percentile (P) of the HD and the 95th (P) of the asymmetric HD distribution
~95% HD modified (HD95_1): different approach by first computing the 95th (P) of the asymmetric HD then taking the maximum
~Dice coefficient
~Difference in volumes"
15831568|NCT04191967|Device|Thermocoagulation|Treatment of positive screening results will be performed using the Liger Thermocoagulator device
15831569|NCT04191954|Drug|Fasudil eye drops (concentration 0.5 percent)|receive Fasudil eye drops (concentration 0.5 percent) twice daily
15831570|NCT04191954|Drug|receive artificial tears drop|receive artificial tears drop with the same frequency
15831571|NCT04191941|Biological|Novel CAR-T|A conditioning chemotherapy regimen of fludarabine and cyclophosphamide may be administered, followed by a single infusion of Novel CAR-T cells
15831573|NCT04191902|Behavioral|orientation|patients will be oriented
15831592|NCT04191694|Other|Chewing Gum|Patients will be given a packet of chewing gum on arrival in the post-operative recovery room. They will be asked to start chewing gum in the recovery room and then asked to chew gum according to their preference over course of the following 24 hours.
15831839|NCT04189666|Drug|Melatonin|compare the ability of the drug in preventing postoperative delirium
15831574|NCT04191889|Combination Product|Hepatic Arterial Infusion combined with Apatinib and Camrelizumab|"Drug: FOLFOX Protocol (Oxaliplatin, fluorouracil, and leucovorin); Camrelizumab for injection and Apatinib-Mesylate Tablets Procedure: 1. On the first day of treatment, HAIC was conducted through a catheter intubated into the tumor feeding artery under DSA guidance with the following chemotherapeutic drugs (mFOLFOX7, oxaliplatin 85 mg/m2 2 hours, folinic acid 400 mg/m2, 5-FU 2500 mg/m2 46 hours) pumped into the tumor artery. The HAIC is repeated every 3 weeks. The cumulative maximum sessions of HAIC is up to 6 times.
~2. Taking Apatinib-Mesylate Tablets (250 mg/tablet) orally on the 8th day 30minutes after meals, once a day, for continuous medication.
~3. On the 22nd day of treatment, namely the second session of HAIC, intravenous infusion of Camrelizumab 200mg every 3 weeks.
~4. The cumulative maximum drug use period is up to 2 years. The patient is concurrent on medication until the treatment discontinuation criteria specified in the protocol appear."
15831575|NCT04191876|Other|Wellth - Financial Incentives|Patients who are willing to participate will be offered financial incentives for medication adherence through an app (Wellth) over 10 weeks.
15831576|NCT04191863|Other|Clinical, EEG and laboratory assessment at presentation|"The patients' history, clinical, demographic, and laboratory data were acquired.
~The following tests and imaging studies are routinely done for epilepsy patients receiving valproate treatment and developed nocturnal enuresis, blood urea nitrogen (BUN), serum creatinine (Cr), urinary pH (before and after valproate therapy beginning and at enuresis onset), serum levels and therapeutic doses of valproate.
~Urinary tract ultrasonography (with full and void bladder).
~CT brain and EEG."
15831577|NCT04191863|Drug|Valproate|valproate monotherapy
15831578|NCT04191850|Procedure|Single Port Video-Assisted Thoracoscopic Surgery|Single Port Video-Assisted Thoracoscopic wedge resection was performed for primary spontaneous pneumothorax.
15831579|NCT04191837|Other|Self-administered acupressure treatment group|Subjects in the self-administered acupressure exercise group will receive two training sessions (2 hours each, 1-week apart). The self-administered acupressure treatment protocol was developed based on Chinese medicine meridian theory by previous studies and modified. The acupoints are indicated for knee pain and have been commonly used and tested for feasibility in pilot study. The training will be conducted in a group format with 4-6 subjects per group. Each subject will then receive a handout and an acupressure log. They will be told to perform the self-acupressure twice per day for 12 weeks.The capability of participants for self-administered acupressure will be inspected by the instructor with a competency checklist in each session. And a demonstration video will be sent to the participants via WhatsApp for their reference at home.
15831580|NCT04191837|Other|Knee health education control group|Subjects in the health education control group will receive knowledge related to knee OA symptom management. The health education will be conducted in a talk format for 2 hours for two sessions. The course content is developed from the course materials from the websites of Elderly Health Service, Department of Health, Hong Kong SAR and reviewed. Subjects in knee health education group will be told to follow the knee health instruction for 12 weeks.
15831581|NCT04191824|Diagnostic Test|APOL1 status|Participants will be randomized to immediate versus delayed return of results for positive or negative APOL1 status.
15831582|NCT04191811|Behavioral|Internet-delivered cognitive behavioral therapy for major depressive disorder|Cognitive behavioral therapy delivered over a period of 12 weeks, guided by a psychologist who provides written feedback on home assignments and questions.
15831583|NCT04191811|Behavioral|Internet-delivered cognitive behavioral therapy for insomnia|Cognitive behavioral therapy delivered over a period of 12 weeks, guided by a psychologist who provides written feedback on home assignments and questions.
15831584|NCT04191811|Behavioral|Internet-delivered cognitive behavioral therapy for health anxiety disorder|Cognitive behavioral therapy delivered over a period of 12 weeks, guided by a psychologist who provides written feedback on home assignments and questions.
15831585|NCT04191798|Behavioral|Telerehabilitation using the KinexConnect system for rehabilitation after TKA.|KinexConnect subjects are asked to Perform CPM therapy for 4 weeks. Perform a KCK home exercise program (HEP) for 6 weeks.
15831586|NCT04191798|Behavioral|Traditional outpatient PT for rehabilitation after TKA.|Control subjects are asked to undergo standard outpatient physical therapy (PT) with a licensed physical therapist plus supplemental home exercises as directed. Nominally patients are expected to have 3 PT sessions per week for 4 weeks.
15831587|NCT04191785|Diagnostic Test|plasmatic NGAl and MRI|Determination of plasma NGAL protein during routine blood test Realization of a reno vesical MRI at 48 hours of inclusion
15831588|NCT04191772|Other|Periodized, home-based running program|All participants will perform a home-based supervised exercise training program. Participants will receive weekly training instructions using a smartphone-based heart rate monitor application (Polar® app). Training sessions will involve running and the design of the training program will be based on linear periodization, where aerobic capacity is built firstly through a period of high-volume/low-intensity training before the proportion of high-intensity training is increased. The total duration of the exercise program will be 12 months with three weekly training sessions. Training progression will be dependent on initial VO2max values and running experience. VO2max classification is based on reference values described in V.H. Heyward, Advanced Fitness Assessment and Exercise Prescription, Fifth Edition, 2006, Champaign, IL: Human Kinetics.
15831589|NCT04191759|Diagnostic Test|Test-Retest reproducibility|Protocol is the same for extended or flexed knee. The testing apparatus was set up as described in the constructor owner's manual and subjects were positioned in the supine lying position. The After a 5 min rest period, the participant's ankle is passively stretched through slow loading cycles from 15° of ankle flexion to 35° of ankle extension. Oral instruction is given to the participants to stay relaxed and avoid any muscle contraction and movement of the leg throughout the passive stretching. To familiarize, participant have 3 repetitions of passive ankle flexion-extension at 5°.s-1, and after 2min rest, data are collected from one repetitions at 5°.s-1 in passive mode. The measurements are also performed at an angular rate of 90°.s-1, according to the same protocol. Data for maximal voluntary isokinetic contraction are collected from 3 maximal repetitions at 60°.s-1 in concentric mode and participant are encouraged by constant verbal stimulation.
15831590|NCT04191733|Device|KINCISE(TM) Surgical Automated System|Uncemented Total Hip Arthroplasty via Anterior Approach with and without the KINCISE(TM) Surgical Automated System
15831591|NCT04191720|Other|Weighted blanket|Patients that were randomly assigned to the intervention group received a weighted blanket to use at their will to reduce anxiety
15831594|NCT04191681|Drug|Sacubitril-Valsartan|Sacubitril-valsartan at low or equivalent dose to be initiated or added to patients randomized to this arm, and titrated up every 2-4 weeks, per standard practice guidelines and label recommendations per physician's discretion.
15831595|NCT04191681|Drug|Usual care (standard-of-care) arm|Other oral vasodilator therapy to be continued or initiated to patients randomized to this arm, and titrated up every 2-4 weeks, per standard practice guidelines and label recommendations per physician's discretion.
15831596|NCT04191668|Device|NightOwl|The NightOwl is a finger-mounted home sleep apnea testing device
15831597|NCT04191655|Device|High Definition Colonoscopy|A colonoscopy that used high definition (HD) camera
15831598|NCT04191655|Device|Dye Spraying Chromocolonoscopy|A colonoscopy that used high definition camera in addition to dye spraying on the interior colon surface.
15831599|NCT04191629|Combination Product|EO1404|
15831600|NCT04191629|Procedure|Endothelial brushing or Descemet stripping|
15831604|NCT04191603|Device|MONOPOLAR HOOC|COLPOTOMY WITH MONOPOLAR HOOC
15831605|NCT04191603|Device|PLASMAKINETIC BIPOLAR SPATULA|COLPOTOMY WITH BIPOLAR SPATULA
15831606|NCT04191590|Procedure|nasal brushing and bacteriological sample|A nasal brushing as well as a bacteriological sample using a swab under general anesthesia at the beginning of the endonasal surgery procedure
15831607|NCT04191577|Drug|CVN424 Low Dose|CVN424
15831608|NCT04191577|Drug|CVN424 High Dose|CVN424
15831609|NCT04191577|Drug|Placebo|Placebo
15831610|NCT04191564|Procedure|low perfusion state|reduce SAP below 100 mmHg
15831611|NCT04191564|Procedure|normal perfusion state|maintain SAP above 100 mmHg
15831612|NCT04191538|Procedure|Conditioning electrical stimulation|Percutaneously, a small needle will be placed alongside the median nerve. Patients will receive 1 hour of 20Hz stimulation with voltage titrated to maintain patient comfort.
15831613|NCT04191538|Procedure|Postoperative electrical stimulation|Immediately following carpal tunnel release, needles for electrical stimulation will be placed alongside the visualized median nerve. Patients will receive 1 hour of 20Hz stimulation with voltage titrated to maintain patient comfort.
15831614|NCT04191538|Procedure|No electrical stimulation|Patients will receive sham stimulation (needles placed, no current delivered) pre- and post-operatively; however, no current will ever be delivered to the nerve. This is the control cohort.
15831615|NCT04191525|Dietary Supplement|BPL-1 Probiotic capsules|BPL-1 Probiotic 1 capsule/day
15831616|NCT04191525|Dietary Supplement|Placebo|Placebo masked with the same presentation as the experimental product 1 capsule/day
15831617|NCT04191499|Drug|Inavolisib|Participants will receive oral inavolisib on Days 1-28 of each 28-day cycle.
15831618|NCT04191499|Drug|Placebo|Participants will receive oral placebo on Days 1-28 of each 28-day cycle.
15831619|NCT04191499|Drug|Palbociclib|Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle.
15831620|NCT04191499|Drug|Fulvestrant|Participants will receive intramuscular (IM) fulvestrant approximately every 4 weeks.
15831621|NCT04191486|Drug|T-817MA|224mg T-817MA orally once daily for first 4 weeks, and then 448mg T-817MA orally once daily for the following weeks.
15831622|NCT04191486|Drug|Placebo|Placebo once daily
15831623|NCT04191473|Procedure|EMR-P|After submucosal injection, we use ESD knife or the tip of the entrapment device to loop around the lesion, and then overlapped the loop tangent with the entrapment device. After tightening the entrapment device, all the tumor tissues were confirmed to enter the entrapment device, and the tissues were removed.
15831624|NCT04191473|Procedure|CEMR|A liquid pad was formed by injecting 0.9% normal saline with meilan solution into submucosa,and then overlapped the loop tangent with the entrapment device. After tightening the entrapment device, all the tumor tissues were confirmed to enter the entrapment device, and the tissues were removed.
15831625|NCT04191460|Drug|cRGD-ZW800-1.|Injection of cRGD-ZW800-1 within 48 hours before imaging/surgery
15831626|NCT04191447|Drug|Flamboyant 200/12|Flamboyant 200/12 capsule
15831627|NCT04191447|Drug|Budesonide / Formoterol 400/12|Budesonide / Formoterol 400/12 capsule
15831628|NCT04191447|Other|Flamboyant 200/12 Placebo|Flamboyant 200/12 Placebo capsule
15831629|NCT04191447|Other|Budesonide / Formoterol 400/12 Placebo|Budesonide / Formoterol 400/12 Placebo capsule
15831630|NCT04191434|Drug|Flamboyant 125/12|Flamboyant 125/12 capsule
15831631|NCT04191434|Drug|Budesonide/formoterol 200/6|Budesonid/formoterol 200/6 capsule
15831632|NCT04191434|Other|Flamboyant 125/12 Placebo|Flamboyant 125/12 Placebo capsule
15831633|NCT04191434|Other|Budesonide/formoterol 200/6 placebo|Budesonid/formoterol 200/6 Placebo capsule
15831634|NCT04191421|Biological|Siltuximab|Given IV
15831635|NCT04191421|Biological|Spartalizumab|Given IV
15831636|NCT04191408|Procedure|PEEP increase|PEEP increase +5 to +15 cmH2O. PLR at 30 degrees.
15831637|NCT04191382|Drug|amcenestrant (SAR439859)|Pharmaceutical form: Capsules Route of administration: Oral
15831638|NCT04191382|Drug|letrozole|Pharmaceutical form: Tablets Route of administration: Oral
15831639|NCT04191369|Diagnostic Test|Esophagogastroduodenoscopy|Esophogagastroduodenoscopy for the evaluation of esophageal varices, gastric varices and hypertensive gastropathy. Portal pressure gradient will be evaluated via interventional radiology as gold standard.
15831640|NCT04191369|Diagnostic Test|Endoscopic ultrasound|"Endoscopic ultrasound evaluation for the presence of esophageal varices, peri and para-esophageal collateral veins, gastric varices, portal hypertensive gastropathy, azygos vein diameter, blood flow and BFVI.
~Portal pressure gradient will be evaluated via interventional radiology as gold standard."
15831641|NCT04191343|Drug|Toripalimab injection combined with GEMOX|Toripalimab Injection (240mg, intravenous drip, d1, q3w);Combined with gemcitabine (1000mg/m2, intravenous drip, d1, d8, q3w) and oxaliplatin (100mg/m2, intravenous drip, d1, q3w)
15831642|NCT04191330|Device|BiovitalsHF|BiovitalsHFTM is a cloud-based, Clinical Decision Support Platform that incorporates continuous physiology data from remote vital signs monitoring devices and electronic patient reported outcome (ePRO) monitoring of subjects at-home to support GDMT dose titration for HFrEF patients.
15831643|NCT04191317|Other|Pain Neuroscience Education and gradual exposure|Education covering the pathophysiology of apin and exercises based on the gradual exposure principle
15831644|NCT04191317|Other|Pilates and postural education|Postural education and pilates exercises
15831647|NCT04191291|Behavioral|Lunch period length|We are randomly allocating a 20 minute or 30 minute lunch period length.
15831648|NCT04191278|Drug|Varenicline|All participants will receive a standard 12-week course of varenicline tartrate. Participants will receive 0.5 mg tablets per oral (PO) once daily for days 1-3, 0.5 mg tablets PO twice daily for days 4-7, and 1 mg tablets PO twice daily for days 8-84
15831649|NCT04191278|Device|Mobile phone application|Participants randomized to 2 of the 3 study groups will receive a mobile phone application designed to improve adherence to medication. The app has a number of functions, including: a) reminders to take medication; b) information about coping strategies for dealing with side effects and withdrawal symptoms; c) provision of a personalized graphical display of treatment progress (e.g., adherence, side effects); d) camera-based verification of having taken medication.
15831650|NCT04191278|Behavioral|Contingency management|Participants randomized to 1 of the 3 study groups will receive monetary reinforcement contingent upon verified medication adherence behaviors. Participants in the other 2 groups will be yoked to a participant in the CM group so that they also have a chance of earning monetary reinforcers, though not contingent upon their own behaviors.
15831651|NCT04191265|Diagnostic Test|serum tropinin, serum CKmb|early detection of myocardial injury, allowing application of acute cardiac shock and cardiogenic shock
15831652|NCT04191252|Diagnostic Test|A multi-gene panel testing|A multi-gene panel, which consists of more than 500 hundred genes will be provided for mutation analysis
15831653|NCT04191239|Device|GE ventilator with two different modes|GE ventilator with two different modes
15831654|NCT04191226|Diagnostic Test|Multi-gene panel testing|A multi-gene panel, which consists of more than 500 hundred genes will be provided for mutation analysis
15831655|NCT04191213|Dietary Supplement|Acacia Senegal extract|Oral Digestion of Gum Arabic to be consumed early morning in daily basis for 12 weeks
15831656|NCT04191213|Dietary Supplement|Pectin|Oral Digestion of Pectin to be consumed early morning in daily basis for 12 weeks
15831657|NCT04191187|Drug|Fludarabine|Fludarabine 30mg/m^2/day will be administered over 30-60 minutes intravenous infusion on Days -6 through -2 for a total dose of 150 mg/m^2
15831658|NCT04191187|Drug|Melphalan|Melphalan 70 mg/m^2 over 45 minutes will be administered Day -6. Melphalan dose will be calculated based on Actual Body Weight.
15831659|NCT04191187|Radiation|Total Body Irradiation|Total Body Irradiation (TBI) will be delivered at a dose of 200 centigray units (cGy)
15831660|NCT04191174|Other|Hyperpolarized 129Xe MRI|Hyperpolarized 129Xe MRI to evaluate ventilation heterogeneity
15831661|NCT04191174|Other|Technegas V SPECT|Technegas V SPECT to evaluate ventilation heterogeneity
15831662|NCT04191174|Other|Sputum Induction|Sputum induction to evaluate luminal cellular inflammation
15831663|NCT04191161|Device|Wearing the rigid brace|Custom braces are made from 4mm thick polyethylene with Velcro® fastening. They are Computer Aided Designed and are made by the same manufacturer (LAGARRIGUE). A thermal sensor chip will placed in the brace to assess observance.
15831664|NCT04191148|Drug|LBP-EC01|crPhage cocktail
15831665|NCT04191148|Drug|Lactated Ringers Solution for Injection|Placebo
15831666|NCT04191135|Biological|Pembrolizumab|intravenous (IV) infusion
15831667|NCT04191135|Drug|Olaparib|oral tablets
15831668|NCT04191135|Drug|Carboplatin|IV infusion
15831669|NCT04191135|Drug|Gemcitabine|IV infusion
15831670|NCT04191122|Other|COPESS|The intervention includes brief psychotherapy to be delivered within primary care settings
15831671|NCT04191109|Other|Observational study|This is an observational study in which the amount of therapy performed during the rehabilitation program will be registered.Data regarding feasibility and safety of the program will be also recorded. Indeed, functional, cognitive and quality of life outcomes will be assessed.
15831672|NCT04191096|Biological|Pembrolizumab|Pembrolizumab is administered as an IV infusion at 200 mg on Day 1 of each 21-day cycle for up to 35 cycles.
15831673|NCT04191096|Drug|Enzalutamide|Enzalutamide is administered orally as capsules/tablets at a dosage of 160 mg daily. Enzalutamide is administered continuously until criteria for discontinuation are met.
15831674|NCT04191096|Procedure|Androgen Deprivation Therapy (ADT)|Stable regimen of ADT (LHRH agonist or antagonist) at a dose and frequency of administration that is consistent with the local product label.
15831675|NCT04191096|Other|Placebo|Placebo infusion solution is administered as an IV infusion on Day 1 of each 21-day cycle for up to 35 cycles.
15831676|NCT04191083|Behavioral|Motor imagery|This group will perform motor imagery training on motor learning of different motor tasks
15831677|NCT04191083|Behavioral|Double time motor imagery|This group will perform motor imagery training by doubling the intervention time to the motor imagery group on motor learning of various motor tasks.
15831678|NCT04191083|Behavioral|Action observation|This group will perform action observation training on motor learning of various motor tasks.
15831679|NCT04191083|Behavioral|Placebo intervention|This group will watch a video of a landscape without the presence of people.
15831681|NCT04191070|Device|zygomatic miniplate|class II correction by distalization using zygomatic miniplate
15831682|NCT04191057|Device|Free light chains|Blood samples will be collected and analyzed
15831683|NCT04191044|Other|A complete cardiovascular and liver characterization will be carried out|A complete cardiovascular and liver characterization will be carried out, including some supplementary tests with minimal risks (e.g. hemodynamic study). If any disease is detected, patients will be referred to the corresponding specialized care following the usual clinical practice.
15831684|NCT04191031|Device|ioveraº|Cryoneurolysis
15831685|NCT04191031|Device|ioveraº sham|ioveraº sham
15831686|NCT04191018|Diagnostic Test|Liver elastography|Liver stiffness measurement
15831687|NCT04191018|Diagnostic Test|Splenic elastography|Splenic stiffness measurement
15831688|NCT04191018|Diagnostic Test|Gastrointestinal endoscopy|Gastrointestinal endoscopy
15831689|NCT04190992|Other|E-based & personalized breast reconstruction surgery decision aid|This decision aid contains information regarding surgical options, including breast reconstruction and mastectomy, such as the advantages and disadvantages, the complication probabilities of each option, a value clarification exercise for the patient's self-evaluation, and a summary of the participant's decision-making process.
15831690|NCT04190992|Other|Usual care|A pamphlet introduce the introduction of types of surgery
15831691|NCT04190979|Device|Medyria TrackCath System|The TrackCath System is a non-implantable device and consists of the TrackCath Catheter and the TrackCath Equipment. It is designed to support the successful positioning of third-party guidewires and catheters in the arterial vasculature to detect and cannulate side branches during endovascular aneurysm repair procedures through the measurement of real-time blood flow velocity changes.
15831692|NCT04190966|Behavioral|Integrated Behavioural therapy|Integrated smoking cessation behavioural therapy
15831693|NCT04190966|Drug|Integrated Pharmacotherapy|Integrated smoking cessation pharmacotherapy including choice of combination nicotine replacement therapy, varenicline or electronic cigarettes
15831694|NCT04190966|Device|Integrated Web-based application|Integrated smoking cessation web-based application
15831695|NCT04190953|Other|Twin block then Hyrax|Patients will undergo mandibular advancement prior to maxillary expansion
15831696|NCT04190953|Other|Hyrax then Twin block|Patients will undergo maxillary expansion prior to mandibular advancement
15831697|NCT04190940|Behavioral|Behavioral Assessment|"Patients will be asked to complete the behavioral assessment before and after their HIFU treatment or on and off their DBS treatment."
15831698|NCT04190927|Biological|Compounded topical estradiol and compounded topical progesterone in a carrier cream|Apply topical compounded estradiol and progesterone in the amount prescribed twice daily for each day of the 28 day lunar or menstrual cycle. Repeat each cycle month. Make note of any AE's so that modifications in dosing can be made.
15831699|NCT04190914|Other|pulp regeneration for necrotic primary teeth|a pulp regeneration procedure will be applied for necrotic primary teeth with different intracanal medication compared to conventional pulpectomy used in treatment for necrotic primary teeth
15831700|NCT04190901|Behavioral|Simulated Black Male Physician|Participants in this arm of the experiment viewed one of 10 randomly selected possible images of a simulated Black Male physician. This image was paired with a written treatment and diagnosis of gastroenteritis alongside a contradictory diagnosis and treatment plan for appendicitis from an Online Symptom Checker.
15831701|NCT04190901|Behavioral|Simulated Black Female Physician|Participants in this arm of the experiment viewed one of 10 randomly selected possible images of a simulated Black Female physician. This image was paired with a written treatment and diagnosis of gastroenteritis alongside a contradictory diagnosis and treatment plan for appendicitis from an Online Symptom Checker.
15831702|NCT04190901|Behavioral|Simulated White Male Physician|Participants in this arm of the experiment viewed one of 10 randomly selected possible images of a simulated White Male physician. This image was paired with a written treatment and diagnosis of gastroenteritis alongside a contradictory diagnosis and treatment plan for appendicitis from an Online Symptom Checker.
15831703|NCT04190901|Behavioral|Simulated White Female Physician|Participants in this arm of the experiment viewed one of 10 randomly selected possible images of a simulated White Female physician. This image was paired with a written treatment and diagnosis of gastroenteritis alongside a contradictory diagnosis and treatment plan for appendicitis from an Online Symptom Checker.
15831704|NCT04190888|Other|No intervention|No intervention - observational study
15831705|NCT04190862|Drug|E-CEL UVEC|Injection of E-CEL UVEC
15831706|NCT04190836|Behavioral|Self-Managed Exercise Strategy|The intervention is a personalised supported self-management intervention which emphasises dynamic, progressively loaded exercises for the shoulder. The intervention consisted of 1-5 individual sessions provided over 3 months, with a duration of 1 hour for the first session and 45 minutes for the following. The participants will have the opportunity to contact the physiotherapist by phone, text message or e-mail for advice during the treatment period (12 weeks). The personalised supported self-management intervention will be based on the components of the self-management framework, provided by Lorig and Holman (2003). The five self-management skills and the operationalization of these will be described when publishing the study. For specific content reporting of the self managed exercises we will follow the Consensus on Exercise Reporting Template.
15831707|NCT04190823|Drug|RC98|Participants will be allocated to one of the following dose groups: 0.003, 0.03, 0.3, 2.5, 5.0, 10.0, 15.0 and 20.0 mg/kg, and receive one treatment of RC98 followed by 28 days of dose limited toxicity (DLT) observation period.
15831708|NCT04190810|Behavioral|Inhibition|Participants receive an Ipad, on which the app is installed. They are instructed to train for a period of three weeks for at least 15 minutes a day.
15831709|NCT04190810|Behavioral|Classical AAT|Participants receive an Ipad, on which the app is installed. They are instructed to train for a period of three weeks for at least 15 minutes a day.
15831710|NCT04190810|Behavioral|Control|Participants receive an Ipad, on which the app is installed. They are instructed to train for a period of three weeks for at least 15 minutes a day.
15831711|NCT04190797|Device|Photobiomodulation + patiente controled anaethesia (PCA)|Patients in the immediate postoperateve of knee arthroplasty surgery treated with the Photobiomodulation device connected, 24h and 48h after the peripheral nerve block (femoral nerve and obturator nerve). With conventional analgesia and with the device of PCA.
15831712|NCT04190797|Device|Placebo + patiente controled anaethesia (PCA)|Patients in the immediate postoperateve of knee arthroplasty surgery treated with the Photobiomodulation device switched off, in 24h and 48h after peripheral nerve bloc (femoral nerve and obturator nerve). With conventional analgesia and with the device of PCA.
15831713|NCT04190784|Other|Stretching exercises|Post-facilitation stretch is a technique involves a maximal contraction of the muscle at mid-range with a rapid movement to maximal length followed by a static stretch.
15831714|NCT04190784|Other|Placebo stretching|The therapist maintains the same manual contact without stretching force.
15831715|NCT04190771|Behavioral|TAU + multicomponent treatment NAT-FM|"Group treatment protocol of 12 weekly 120 minute sessions. All sessions include the following ingredients (approx. in the same order):
~Pain neuroscience education (30 min.)
~Cognitive restructuring (30 min.)
~Mindfulness techniques (30 min.)
~Physical exercise in a natural environment / nature exposure (30 min.) Treatment as Usual (TAU) Standard pharmacological treatment usually provided to patients with fibromyalgia."
15831716|NCT04190771|Behavioral|Treatment as Usual (TAU)|Standard pharmacological treatment usually provided to patients with fibromyalgia.
15831717|NCT04190758|Other|Care as usual|No intervention will be given. The study will follow the effects of care as usual.
15831718|NCT04190745|Drug|Toripalimab+Apatinib mesylate|Toripalimab 240mg, ivgtt, Q3w Apatinib mesylate 250mg PO. QD
15831719|NCT04190745|Drug|paclitaxel|paclitaxel 80mg/m2, q3w
15831720|NCT04190732|Behavioral|Physician phone call|Often, patients will not have contact with a physician during the waiting period between embryo transfer and the pregnancy test. Participants in the intervention group will receive a phone call from one physician 3 to 4 days after fresh or frozen embryo transfer to check in. The physician will introduce themselves and state they are a part of the research team.
15831721|NCT04190719|Other|multimodal prehabilitation|"Paprika prehabilitation program content: patients will have choices for each activity. Messages and motivation will be reinforced by using a mobile app or leaflet advices, according to patient's preferences.
~Physical activity promotion by discovering ebike, personalised gymnastics and encouragement to increase the number of daily steps of patients, measured by a wristband and a mobile App
~An individualized nutritional optimization plan with dietary advices and protein supplementation (if necessary).
~Psychological support will be proposed through auto-hypnosis sensibilisation or management of stress with Cognitive Behavior Stress Management technics"
15831722|NCT04190706|Other|bioactive components fortified food products intake (biscuits and cookies)|Volunteers will have to consume daily 100 g of fortified biscuits and cookies instead of those usually consumed during nine weeks. The last week, volunteers will have to consume daily a fructose solution (3g/kg fat free mass)
15831723|NCT04190706|Other|control food products intake (biscuits and cookies)|Volunteers will have to consume daily 100 g of standard biscuits and cookies instead of those usually consumed during nine weeks. The last week, volunteers will have to consume daily a fructose solution (3g/kg fat free mass)
15831724|NCT04190693|Drug|IMCY-0098 or placebo|Long-term follow-up
15831725|NCT04190680|Behavioral|Kokkerelli Learning Street|"The Kokkerelli Learning Street focusses on one specific food product (kale, tomato, asparagus, pepper, strawberry, blue berry, mushroom, carrot, or leek) and consists of multiple components:
~An introduction lesson at school. Children are introduced to the product and familiarised with growing and harvesting processes and the importance of the product regarding health.
~A visit to a grower's farm during which children are introduced to the precise planting, growing and harvesting procedures of the product. Children are allowed to enter the facilities (e.g., the greenhouse) and observe and experience the farming of the product.
~A cooking workshop at the facilities of Kids University for Cooking BV. Children prepare a meal with help of volunteers. After preparing the meal, children help to set the table and consume their self-prepared meal.
~An evaluation lesson at school. Children evaluate the Learning Street together with their peers and teacher."
15831726|NCT04190667|Diagnostic Test|Genomic testing|A multi-panel testing of 36 genes would be given for these patients in their peripheral blood and tumor tissues. These 36 genes include: BRCA1, BRCA2, ABRAXAS1(FAM175A）, ATM, ATR, BAP1, BARD1, BRIP1, C11ORF30（EMSY）, CDK12, CHEK1, CHEK2, FANCA, FANCC, FANCD2, FANCI, FANCL, MRE11A, NBN, PALB2, PPP2R2A, PTEN, RAD50, RAD51B, RAD51C, RAD51D, RAD54B, RAD54, MLH1, MSH2, MSH6, PMS2, EPCAM, STK11, TP53, CDH1. The study would select 150 patients with pathogenic or likely pathogenic mutations in BRCA1/2 and 150 patients without these mutations to further explore the HRD status.
15831727|NCT04190654|Drug|KW-6356|Single oral dose of KW-6356
15831728|NCT04190641|Device|Ambu aScope 4 Cysto and aView Urologia|Visualization of the urethra and the bladder
15831729|NCT04190628|Drug|ABM-1310|Part A: Starting dose at 25 mg po bid. Part B: Starting dose at a dose below the MTD that has been demonstrated to be safe in Part A.
15831730|NCT04190628|Drug|Cobimetinib|"Part B: orally administered once daily.
~Dose formulation is 60 mg capsules."
15831731|NCT04190615|Diagnostic Test|thromboelastometry test (TEM test)|TEM test from the whole blood sample
15831732|NCT04190602|Device|NeoChord Artificial Chordae Delivery System, Model DS1000|The intended use of the device is for the placement of artificial chordae when the natural chordae tendinae have become elongated or ruptured due to degenerative valve disease.
15831733|NCT04190589|Device|Robot-assisted laparoscopic extended right colectomy|An extended right hemicolectomy with total mesocolic excision and meticulous central dissection as described by Hohenberger will be performed with the DaVinci Xi robot by one of two dedicated surgeons
15831734|NCT04190576|Device|Low Level Laser Therapy|Hydroxyapatite bone graft with collagen
15831735|NCT04190563|Behavioral|Pain De-Catastrophizing|Experimenter-administered education and skill practice.
15831736|NCT04190563|Behavioral|Pain Education|Experimenter-administered education.
15831737|NCT04190550|Drug|Cytarabine|Given IV
15831738|NCT04190550|Drug|Idarubicin Hydrochloride|Given IV
15831739|NCT04190550|Drug|MDM2 Inhibitor KRT-232|Given PO
15831742|NCT04190511|Dietary Supplement|Prebiotic-containing dairy|The trained dietitian gives guidance on diet, exercise, and weight gain during pregnancy based on the Maternal Dietary Guidelines and Dietary Pagoda recommendations developed by the Chinese Institute of Maternal and Child Nutrition. On this basis, intervention was carried out using prebiotic-containing dairy products (200g/day).
15831743|NCT04190511|Dietary Supplement|Dietary intervention|The trained dietitian gives guidance on diet, exercise, and weight gain during pregnancy based on the Maternal Dietary Guidelines and Dietary Pagoda recommendations developed by the Chinese Institute of Maternal and Child Nutrition.
15831744|NCT04190498|Diagnostic Test|Nocturnal oximetry|Diagnosis of OSA will be based on the 3% Oxygen Desaturation Index (IDO) obtained by home nocturnal oximetry. The oximetry recordings will be centralized in sleep laboratory of the University Hospital of Grenoble Alpes. Oximetry data will be analyzed by a technician from the sleep laboratory of the University Hospital of Grenoble Alpes
15831745|NCT04190485|Other|Placebo|Subjects will be randomized to one of two groups, using placebo toothpastes for 4 weeks, and then will enter a 1 week-washout and afterward will be crossed over to the opposite treatment for 4 weeks.
15831746|NCT04190485|Other|GMNL-143 Probiotic Toothpastes|Subjects will be randomized to one of two groups, using GMNL-143 probiotic toothpastes toothpastes for 4 weeks, and then will enter a 1 week-washout and afterward will be crossed over to the opposite placebo for 4 weeks.
15831747|NCT04190485|Other|GMNL-464 Probiotic Toothpastes|Subjects will be randomized to one of two groups, using GMNL-464 probiotic toothpastes for 4 weeks, and then will enter a 1 week-washout and afterward will be crossed over to the opposite placebo for 4 weeks.
15831748|NCT04190472|Diagnostic Test|IOP HPV test|Immediately after the LEEP, a cervical sample was taken for the IOP-HPV test
15831749|NCT04190459|Procedure|LSG|Bariatric surgery
15831750|NCT04190459|Procedure|LRYGB|Bariatric surgery
15831751|NCT04190446|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
15831752|NCT04190446|Radiation|Proton Beam Radiation Therapy|Undergo proton beam radiation therapy
15831753|NCT04190446|Other|Quality-of-Life Assessment|Ancillary studies
15831754|NCT04190446|Other|Questionnaire Administration|Ancillary studies
15831755|NCT04190433|Drug|Carvedilol|Up-titrated to maximum tolerated doses as per standard clinical practice
15831756|NCT04190433|Drug|Lisinopril|Up-titrated to maximum tolerated doses as per standard clinical practice
15831757|NCT04190433|Drug|Pravastatin|40 mg per day
15831758|NCT04190433|Drug|Spironolactone|25 mg per day
15831759|NCT04190407|Behavioral|Intravenous access|A tourniquet was used to raise the vein for entry into the vein every 15 s after the ciliary reflex disappeared. If the patient showed no response to the tourniquet (movement, coughing, or laryngospasm), an experienced anesthesiologist entered a vein in the dorsum of one hand using a 22-24 gauge cannula.
15831760|NCT04190394|Other|Intermittent retraining program.|Patient benefits from an intermittent retraining program for 8 weeks, with three 45-minute sessions per week.
15831761|NCT04190381|Other|FR-Mask|"The investigational medical product of this study is a biomedical repair mask, FR-MASK, acting like moisturizing lotion applied on breasts.
~The FR-Mask is applied to users' radiation-irritated breast skin for 15 to 20 minutes every 3 days."
15831762|NCT04190368|Other|Team Clinic Care|"Participants attend quarterly visits (1 visit every 3months). Appointments scheduled for Telehealth (TH) (1 in-person visits) as decided by provider/patient.
~Selected providers will be trained in the Team Clinic Care protocol for completing medical appointments. Team Clinic Care key components:
~(1) Shared decision making: Providers, AYA, parent/caregiver will mutually agree on priorities for each medical visit using a shared decision making tool (2) Autonomy supportive care: Providers will be trained in skills building, patient centered key elements, intervention bites, reviewing plans, designed to support AYA autonomy and intrinsic motivation. AYA will also direct extent of eligible family involvement. (3) Goal setting and action planning: Providers will be trained to coach AYA in setting SMART goals, developing action plans, and establishing a plan for follow-up between visits as appropriate. (4) Fidelity Review and process for self-assessment"
15831763|NCT04190368|Other|Standard Care|Participants attend quarterly visits (1 visit every 3 months) and see their diabetes care provider. They do not participate in Team Clinic group visits but if they need diabetes education or supportive services they will be referred for necessary care per usual methods.
15831764|NCT04190355|Other|Irrigant type|The success of endodontic treatment is directly related to infection control. In successful endodontic treatment, it is necessary to perform an ideal irrigation both in order to gain a better understanding of the complex anatomical structure of the root canals and to increase the efficiency of the instruments and methods used during the canal preparation. Sodium hypochlorite (NaOCl) solution is the standard irrigation agent for cleaning and disinfection of root canal. In this study, the effect of NaOCI on postoperative pain using different uniforms will be evaluated.
15831765|NCT04190355|Drug|5.25% NaOCl|5.25% NaOCl solution
15831766|NCT04190355|Drug|5.25% Cloraxid gel/ distilled water|5.25% Cloraxid gel/ distilled water
15831767|NCT04190342|Other|control group|A booklet on the self-management of cancer symptoms. After the pilot RCT is completed, if the participants allocated to the control group are interested in practising tai chi, the intervention will be provided
15831768|NCT04190342|Behavioral|tai chi group|Around 60 minutes practising easy tai chi movements/postures twice per week
15831769|NCT04190316|Other|Evaluation of fecal RA and environmental contamination of ESBL-PE carrier in ICU|ESBL-PE carriers included in the study will be sampled for evaluation of their fecal RA of ESBL-PE on day 0, 3, 5, 7, 10, 14 and weekly till day 30 or their discharge from ICU. Urine and respiratory samples will be collected on the same day to identify multiple-site colonization with ESBL-PE. Seven samples of patient care environment will be performed 2-times a week till day 30 or discharge of the patient from the ICU.
15831770|NCT04190303|Other|Pragmatic, multi-component package|This system-level intervention will be tailored to the needs and capacity of each hospital site, co-developed with policymakers and hospital staff
15831771|NCT04190290|Other|Physiotherapy Adapted Program|3 days / week mobilisations and respiratory exercises and body image exercises
15831772|NCT04190290|Diagnostic Test|Evaluation and Control|Manual muscle test MRC score, peak-expiratory-flow test, hand strength test, 6 minutes walking test, SF-36, EDI-3 and EDQOL
15831773|NCT04190277|Device|Open-loop condition|Patient's standard insulin pump setting combined with continuous glucose monitoring sensor
15831774|NCT04190277|Device|Closed-loop condition|Closed-loop algorithm system paired with continuous glucose monitoring sensor
15831775|NCT04190264|Device|Thermal Rehabilitation Machine|The Polar Breeze unit is a microenvironmental air-chiller. That means it is a single-pass air-conditioner capable of cooling external air
15831776|NCT04190264|Other|Cold Water Immersion|Whole-body immersion in cold water.
15831777|NCT04190251|Other|Inteprofessional medication adherence support program (IMAP)|In addition to usual care, patients participate in a medication adherence support program combining an Electronic Monitoring system (EM, named MEMS®; Aardex Ltd) and motivational semi-structured interviews. This programm is done by the Unisanté's community pharmacists, in coordination with medical and nurse staff , to support medication adherence and to promote continuity of care. The intervention is held at the Unisanté's community pharmacy. For patients not speaking french, english, or italien, the interviews will be done with a interpreter.
15831778|NCT04190238|Other|Super inductive system (high frequency electromagnetic field)|Super inductive system (high frequency electromagnetic field)
15831779|NCT04190238|Other|Physical therapy|specific for spasticity
15831780|NCT04190225|Behavioral|Digital/social media intervention|Participants will receive individual counseling, access to an individually tailored website, guided goal setting via texts, access to a study Instagram account, and a wearable tracker (Fitbit)
15831781|NCT04190212|Behavioral|High-intensity interval training + standard care|HIIT sessions will include: (1) warm-up for 2 minutes at 50% of peak power output (PPO); (2) 2 x 8-minute interval training blocks (total: 16 minutes) of 30-seconds at 80-100% of PPO interspersed with 30-seconds active recovery, 4 minutes of recovery will be permitted between the blocks; and, (3) 2 minute cool-down at 25% of PPO after the last 30-second exercise bout.
15831782|NCT04190199|Other|Observational|Cross-sectional only
15831783|NCT04190186|Device|Insertable Cardiac Monitor|Implantable device that provides accurate daily transmission of cardiac electrical data for arrhythmia detection.
15831784|NCT04190173|Drug|Prucalopride|1-2 mg once daily enteral feeding for 5 consecutive days
15831785|NCT04190173|Drug|Placebo|1/2-1 tablet once daily enteral feeding for 5 consecutive days
15831786|NCT04190160|Drug|IDegLira|A single administration of IDegLira, dose depending on glicaemic control, in place of any pre-existing hipoglycaemic therapeutic scheme
15831787|NCT04190147|Other|Structural, functional and metabolic eye examinations|Structural, functional and metabolic eye examinations
15831788|NCT04190134|Behavioral|Socially Assistive Robot for Low Vision Rehabilitation|A socially assistive robot will be customized to engage in dialog and conversations to motivate and encourage optimal use of new magnification devices for reading at home by individuals with vision loss.
15831789|NCT04190121|Dietary Supplement|prosure|The study group will receive the dietary supplement preoperatively and for three months after the operation
15831790|NCT04190108|Diagnostic Test|Fecal calprotectin assay|FC levels were measured at baseline with Bühlmann fCAL Turbo, Switzerland® kit.
15831791|NCT04190095|Device|Motion Tracking in VR|Participant will wear motion sensors and VR devices
15831792|NCT04190095|Behavioral|VR Interaction|Participant will perform VR interaction task
15831793|NCT04190069|Behavioral|Behavioral interventions/modifications|UPMC Prescription for Wellness is an innovative physician/provider prescribed coaching and feedback program that improves patient engagement and outcomes in healthy behaviors; self-care of chronic disease and condition management; and shared decision-making. The resources available through this program are offered via a telephonic health coach, online or through a digital intervention based on the participant's convenience.
15831794|NCT04190056|Biological|Pembrolizumab|Given IV
15831795|NCT04190056|Drug|Tamoxifen|Given PO
15831796|NCT04190056|Drug|Vorinostat|Given PO
15831797|NCT04190030|Behavioral|mindfulness training|Participants will listen to 20-minute lessons each day for 14 days plus complete brief (3 to 10 minute) exercises daily via their personal smartphone. Each course will involve mental exercises to reduce stress in daily life, along with direct instruction from the course leader to help in learning and applying the stress reduction techniques.
15831798|NCT04190030|Behavioral|cognitive reappraisal training|Participants will listen to 20-minute lessons each day for 14 days plus complete brief (3 to 10 minute) exercises daily via their personal smartphone. Each course will involve mental exercises to reduce stress in daily life, along with direct instruction from the course leader to help in learning and applying the stress reduction techniques.
15831799|NCT04190017|Other|Cranial MRI|Cranial MRI
15831800|NCT04190004|Drug|Vasopressins|40 International units of vasopressin or placebo will be given intra-nasally. The order of the administration will be counterbalanced
15831801|NCT04190004|Drug|Placebo|40 International units of vasopressin or placebo will be given intra-nasally. The order of the administration will be counterbalanced
15831802|NCT04189991|Device|Free 02|"With the manual oxygen titration, the physiotherapist adjust manually the oxygen flow using the FreeO2 device during a titration 6 minutes walk test.
~With the automated adjustment oxygen titration, the flow will be self adjusted by the FreeO2 device during a titration 6 minutes walk test. In that hase, the median flow rate and the 95th flow rate will be evaluated during the validation 6 minutes walk test."
15831803|NCT04189978|Diagnostic Test|Clinical evaluation|The assessment is based on a comprehensive questionnaire, a simple clinical examination, an spirometry test, allergic skin tests, measurement of the exhaled fraction of NO (FeNO) and blood serum analysis.
15831804|NCT04189965|Other|Validation of virtual environment and auditive stimulation with virtual reality glasses (Pilot phase)|The goal of this phase is the development of the experimental protocol in virtual reality. Virtual environment will be checked and auditive stimulation will be graduated.
15831840|NCT04189653|Other|Continuous Monitoring|Wireless continuous vital sign monitoring (HR, RR, SBP/DBP, SAT)
15832388|NCT04185415|Drug|Placebo|"Pharmaceutical Form: Solution for infusion
~Concentration: 0.9% w/v sodium chloride aqueous solution
~Route of Administration: Intravenous"
15831805|NCT04189965|Other|Electrical cutaneous stimulation and auditive stimulation (Experimental phase)|This phase is the principal step of the study: during moving in virtual environment, electrical stimulation on one hand and auditive stimulation will be applied. EEG, ECG and skin conductance will be measured during conditioning phase and extinction phase (day 1, 30 minutes each phase). Behavioral measures will be done throughout the 3 sessions (day 1, day 2 and day 30)
15831811|NCT04189939|Other|clinical assessments|"Behavioral tasks will be executed via a computer interface. Below, we provide an estimated timeline for each visit and subsequently provide detail for the relevant stages.
~Each participant's visit will last approximately 4-5 hours. Each visit will consist of the following tasks (in this order):"
15831812|NCT04189900|Drug|Triptorelin|Subjects receive a single subcutaneous dose of 0,1 mg of Triptorelin acetate.
15831813|NCT04189887|Behavioral|aerobic exercise (cycling)|People who perform aerobic exercise will ride on a stationary bike for 20 minutes after motor skill learning
15831814|NCT04189887|Behavioral|Implicit sequence learning|All participants will practice the serial reaction time task (SRTT) on the first day, and retention performance will be assessed immediately, on the 2nd day, and on the 7th day of study.
15831815|NCT04189874|Diagnostic Test|Conventional Stool Testing|Stools are tested using conventional culture techniques
15831816|NCT04189874|Diagnostic Test|BioFire FilmArray Gastrointestinal Panel|Molecular-based stool assay
15831817|NCT04189848|Drug|Semaglutide|Subjects will receive 1 dose of semaglutide 0.25 mg and 1 dose of dulaglutide 0.75 mg on the same day.
15831818|NCT04189848|Drug|Dulaglutide|Subjects will receive 1 dose of semaglutide 0.25 mg and 1 dose of dulaglutide 0.75 mg on the same day.
15831819|NCT04189835|Diagnostic Test|EBV DNA in whole blood and plasma|Consecutive measurements of EBV DNA in whole blood and plasma
15831820|NCT04189796|Dietary Supplement|Cheese|Daily oral intake of cheese
15831821|NCT04189783|Drug|Liposomal Bupivacaine|Patients receive standard of care liposomal bupivacaine injection before and during surgery, followed by standard of care non-opioids and opioids at days 0-3 after surgery in the absence of unacceptable toxicity
15831822|NCT04189783|Drug|Quadratus Lumborum Block|"Patients receive standard of care liposomal bupivacaine injection before and during surgery, followed by standard of care non-opioids and opioids at days 0-3 after surgery in the absence of unacceptable toxicity. Patients receive a second liposomal bupivacaine injection (RESQU block) on day 4 after surgery"
15831823|NCT04189783|Other|Questionnaire Administration|Ancillary studies
15831824|NCT04189770|Device|Accelerometer|Wear accelerometer
15831825|NCT04189770|Other|Ecological Momentary Assessment|Complete EMA questionnaire
15831826|NCT04189770|Other|Questionnaire Administration|Complete questionnaire
15831827|NCT04189770|Other|Survey Administration|Complete survey
15831828|NCT04189757|Drug|Acalabrutinib|Given PO
15831829|NCT04189744|Drug|IPTp-sulphadoxine-pyrimethamine plus metronidazole|Metronidazole (MTZ) is indicated for the treatment of BV and TV and is also safe to administer in the second and third trimesters of pregnancy, and its use with SP or DP may result in better birth outcomes than SP alone. Malaria parasites have developed resistance against SP and the treatment is sub-optimal at clearing malaria infection compared to dihydroartemisinin-piperaquine (DP), therapy that has a suitable profile for use in IPTp. This intervention arm can be compared to the intervention arm IPTp-DP plus MTZ to assess whether DP is superior to SP in preventing adverse birth outcomes. This intervention arm will also be compared to the IPTp-SP plus MTZ placebo arm to assess whether the combination of MTZ with IPTp-SP is superior to IPTp-SP alone in reducing adverse pregnancy outcomes.
15831830|NCT04189744|Drug|IPTp-dihydroartemisinin-piperaquine plus metronidazole|Metronidazole (MTZ) is indicated for the treatment of BV and TV and is also safe to administer in the second and third trimesters of pregnancy, and its use with SP or DP may result in better birth outcomes than SP alone. Malaria parasites have developed resistance against SP and the treatment is sub-optimal at clearing malaria infection compared to dihydroartemisinin-piperaquine (DP), therapy that has a suitable profile for use in IPTp. This intervention arm can be compared to the intervention arm IPTp-SP plus MTZ to assess whether DP is superior to SP in in reducing adverse pregnancy outcomes.
15831831|NCT04189744|Drug|IPTp-sulphadoxine-pyrimethamine|The World Health Organization (WHO) recommends providing intermittent preventive treatment (IPTp) using sulphadoxine-pyrimethamine (SP) to pregnant women during the second and third trimesters of pregnancy to clear placental infection.
15831832|NCT04189718|Procedure|osseodensification protocol|Local anaesthesia was administered and mucoperiosteal flap was reflected. Implant osteotomies was performed with sequential drilling with osseodensification protocol at 1100 rpm. The pilot drill was used in clockwise direction and the other sequential drills were used in counter clockwise direction under copious irrigation. Flap closure was achieved using 3-0 silk sutures to protect the implant site.
15831833|NCT04189718|Procedure|conventional implant site preparation protocol|Local anaesthesia was administered and mucoperiosteal flap was reflected. Implant osteotomies was performed with sequential drilling with conventional implant site preparation protocol at 1100 rpm. The pilot drill was used in clockwise direction and the other sequential drills were used in clockwise direction under copious irrigation. Flap closure was achieved using 3-0 silk sutures to protect the implant site.
15831834|NCT04189705|Drug|MCT-SR|Rebamipide 150mg
15831835|NCT04189705|Drug|Mucosta Tab.|Rebamipide 100mg
15831836|NCT04189679|Other|Immune signature in serum associated to the metabolic signature|Immune signature in serum associated to the metabolic signature
15831837|NCT04189679|Genetic|Meta-genomic signature of intestinal flora|Meta-genomic signature of intestinal flora
15831838|NCT04189666|Drug|Rivastigmine Transdermal System [Exelon]|compare the ability of the drug in preventing postoperative delirium
15831841|NCT04189640|Drug|Postoperative analgesia management|Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure. If the VAS score will be ≥ 4, 0.5 mg/ kg tramadol IV will be administered.
15831843|NCT04189601|Diagnostic Test|Complement measurements|Blood and urine tests to assess the complement activation state
15831844|NCT04189588|Drug|Cetirizine HCl 10 mg/mL|Comparison of two injectable products: cetirizine HCl 10 mg/mL and diphenhydramine 50 mg/mL, both administered during a 1 to 2-minute period by IV push using a 1 mL syringe
15831845|NCT04189588|Drug|Diphenhydramine 50 mg/mL|Comparison of two injectable products: cetirizine HCl 10 mg/mL and diphenhydramine 50 mg/mL, both administered during a 1 to 2-minute period by IV push using a 1 mL syringe
15831846|NCT04189588|Drug|anti-CD20 such as Rituximab or Paclitaxel|Compare the incidence of infusion reactions to treatment with an anti-CD20 such as Rituxan® (Rituximab) or Taxol® (Paclitaxel) after premedication with intravenous (IV) QUZYTTIR™ cetirizine hydrochloride (HCl) or IV diphenhydramine during first-cycle infusion or re-treatment. Re-treatment is defined as re-treatment with Rituxan® (Rituximab) or Paclitaxel after 6 months in patients with persistent infusion reactions while on maintenance or re-treatment.
15831847|NCT04189575|Other|SMS Intervention|Delivery of text messages will use the Rip Road Mobile platform.
15831848|NCT04189562|Other|SMS Intervention|Delivery of text messages will use the text messaging program Simple Online Family Intervention for ADHD (SOFIA).
15831849|NCT04189549|Diagnostic Test|CNA Rapid Sepsis Dx|Novel biomarker based on circulating cell-free DNA (cfDNA) in the human blood stream
15831850|NCT04189536|Other|SMS Intervention|Delivery of text messages will use the Rip Road Mobile platform.
15831851|NCT04189523|Other|SOC Pain Management|Study subjects will be compared to historical controls selected for same age +/- 5yrs, gender, fracture type who meet the inclusion criteria and do not have historical documentation of one of the exclusion criteria. Controls will be identified by the ICD-10 injury codes selected for use in this study. Clinical course and pain management data will be collected through the EMR only.
15831852|NCT04189523|Procedure|Early US Guided Nerve Block Administration|US-Guided regional anesthesia (fascia illiaca compartment block or brachial plexus block)
15831853|NCT04189510|Device|Artificial Pancreas|The Artificial Pancreas will delivery insulin in place of Multiple Daily Injections after a kidney transplant.
15831854|NCT04189510|Other|Multiple Daily Injections|Multiple Daily Injections as standard of care post kidney transplant.
15831855|NCT04189484|Biological|Evolocumab|Evolocumab 21 mg administered SC
15831856|NCT04189484|Biological|Evolocumab|Evolocumab 35 mg administered SC
15831857|NCT04189484|Biological|Evolocumab|Evolocumab 70 mg administered SC
15831858|NCT04189484|Biological|Evolocumab|Evolocumab 140 mg administered SC
15831859|NCT04189484|Biological|Alirocumab|Alirocumab 15 mg administered SC
15831860|NCT04189484|Biological|Alirocumab|Alirocumab 25 mg administered SC
15831861|NCT04189484|Biological|Alirocumab|Alirocumab 50 mg administered SC
15831862|NCT04189484|Biological|Alirocumab|Alirocumab 100 mg administered SC
15831863|NCT04189484|Biological|Placebo|Placebo administered SC
15831864|NCT04189458|Other|Multimodal exercise program|Each session includes: beginning ritual (5 min), warm-up (15 min), main section comprising the multimodal exercises (30 min), cool-down (5 min), and finishing ritual (5 min). At the initial stage, the activation of different muscle groups will be performed. The main section (multimodal exercises) will be focused on the specific objectives through sensorimotor and neurocognitive activities and will privilege IPS. This section includes periods ranging 10-15 min of exercises mainly focused on motor stimulation - physical fitness (strength, balance and agility) - alternating with exercises mainly focused on cognitive stimulation - CF (planning ability, solving-problems, IPS, attention and DT performance). At the cool-down the participants will normalize their physiological parameters. Finally, at the finishing ritual the participants sign an attendance sheet regarding the session, including perceived exertion (Borg Scale) and satisfaction (Caregiver Treatment Satisfaction questionnaire).
15831865|NCT04189445|Drug|Futibatinib|Futibatinib tablets will be dosed orally every day on a continuous 28-day cycle
15831866|NCT04189432|Biological|SCM-CGH|SCM-CGH will be administrated 3 times with 2-week intervals by IV infusion to subjects at Weeks 0, 2 and 4 (Visits 2, 3 and 4).
15831867|NCT04189432|Other|Placebo|Placebo will be administrated 3 times with 2-week intervals by IV infusion to subjects at Weeks 0, 2 and 4 (Visits 2, 3 and 4).
15831868|NCT04189419|Biological|SCM-AGH|SCM-AGH will be administrated once a day for 3 days(D0, D1 and D2).
15831869|NCT04189419|Other|Placebo|Placebo will be administrated once a day for 3 days(D0, D1 and D2).
15831870|NCT04189406|Other|Venapunction|A blood sample of 3.5 mL (0.2 mL serum for FSH and LH, 0.15 mL serum for E2, 0.15 mL serum for T, 0.15 mL serum for AMH and 0.25 mL serum for Inhibin B) will be collected of all girls with TS at 3 months and 9 months of age. For the girls with TS, this will be collected with an extra venapuncture during a regular outpatient visit within the usual care.
15831871|NCT04189380|Other|HLQ (Health literacy questionnaire)|each patient complete survey and self-assessment questionnaire before or after his medical consultation
15831872|NCT04189380|Other|MoCA (Montreal Cognitive Assessment)|each patient complete survey and self-assessment questionnaire before or after his medical consultation
15831873|NCT04189367|Drug|Traditional Chinese Medicine|"One bag of  Qingre Liangkou Ningxin Fang at a time, three times a day for 12 weeks."
15831874|NCT04189367|Drug|Western medicine|"Western medicine includes:
~clonazepam 0.5mg every day before sleep or twice a day for 12 weeks
~Nutritional supplement: vitamin B12, folic acid, iron, zinc, vitamin B complex depending on the hematic deficiency, for 12 weeks"
15831875|NCT04189354|Device|Transcranial direct current stimulation (t-DCS) device|t-DCS is a brain electrostimulation technique that consists of applying a current of low intensity (between 1 and 2 mA) on the scalp via two electrodes, in order to modify the cerebral activity of the stimulated zones. The investigators use the Soterix Medical t-DCS devices of the mini-CT 1x1 type.
15831943|NCT04188873|Behavioral|Minimal Counseling|2 brief phone or video counseling sessions
15831876|NCT04189341|Drug|Erector spinae plane block (Group E)|Patients will be administered A 400 mg dose of ibuprofen every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.
15831877|NCT04189341|Drug|Modified-thoracolumbar interfascial plane block|Patients will be administered A 400 mg dose of ibuprofen every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.
15831878|NCT04189328|Procedure|dental implant placement using magnifying loupes and microsurgical instruments|microsurgical dental implant placement employin splt finger technique by Misch
15831879|NCT04189328|Procedure|macrosurgical dental implant placement|macrosurgical placement of single dental implants
15831880|NCT04189315|Drug|asfotase alfa|Asfotase alfa is administered subcutaneously.
15831881|NCT04189302|Procedure|connective tissue graft harvest using KPM blade|after local anesthesia is injected, the surgical procedure is initiated with 15 C blade and the connective tissue graft is detached from epithelium and underlying periosteum. then the connective tissue is harvested with the help of 2 vertical and 1 horizontal incisions using KPM blade.
15831882|NCT04189302|Procedure|connective tissue graft harvest using 15 C blade|after local anesthesia is injected, the surgical procedure is initiated with 15 C blade and the connective tissue graft is detached from epithelium and underlying periosteum. then the connective tissue is harvested with the help of 2 vertical and 1 horizontal incisions using 15C blade.
15831883|NCT04189289|Procedure|ESP block group|USG probe will be placed in a longitudinal parasagittal orientation 3 cm lateral to T7 spinous process. The erector spinae muscles will be identified hyperechoic transverse process. The patient's skin will be anesthetized with 2% lidocaine. A 21-gauge 10-cm needle was inserted using an in-plane superior-to-inferior approach or an out-plane approach. Following confirmation of the correct position of the needle with 5 ml normal saline, a dose of 20 ml %0.25 bupivacaine will be administered. The same procedure will be performed at the other site (totally 40 ml %0.25 bupivacaine). Standard pain follow up and monitorization will be performed.
15831884|NCT04189289|Procedure|Control group|The patients in this group will be performed no block. Standard pain follow up and monitorization will be performed.
15831885|NCT04189276|Biological|ETV/TDF+T101 No.1|Patients will be injected with T101 once on Day1 (Week0), Day8 (Week1), Day15 (Week2), Day106 (Week15), Day113 (Week16), Day120 (Week17), Day211 (Week30), Day218 (Week31), Day225 (Week32), Day316 (Week45), Day323 (Week46), Day330 (Week47); ETV or TDF will be administrated once each day successively until Day420.
15831886|NCT04189276|Biological|ETV/TDF+T101 No.2|Patients will be injected with T101 once on Day1 (Week0), Day106 (Week15), Day211 (Week30), Day316 (Week45); ETV or TDF will be administrated once each day successively until Day420.
15831887|NCT04189276|Biological|ETV or TDF|Patients will be administrated ETV or TDF once each day successively until Day420.
15831888|NCT04189276|Biological|ETV/TDF+Peg-IFNα-2b|Patients will be administrated Peg-IFNα-2b successively once a week until Day330 (Week47); ETV or TDF will be administrated once each day successively until Day420.
15831889|NCT04189263|Other|Carbohydrate restricted dietary intervention|Carbohydrate restricted dietary intervention (<20 g carbohydrates/day)
15831890|NCT04189263|Drug|standard of care aromatase inhibitors|standard of care aromatase inhibitors
15831891|NCT04189250|Device|Automatized carbonmonoxide rebreathing machine - OpCO Detalo instruments|The automatized protocol (aCO) will be conducted with automated system OpCO of Detalo instruments. The intended use of the OpCO Detalo instrument is to quantify hemoglobin mass in human. The principle behind the machine is the widely used CO rebreathing technique. The machine applies automatically the desired CO dose to the patient to determine hemoglobin mass. The Detalo Instruments OpCO is certified conform to the following CE norms: Electromagentic compabilitiy: DIN EN 60601-1-2 and electrical Safety test: LVD 2014/35/EU.
15831892|NCT04189237|Other|Electroacupuncture|needles were inserted to Taixi (KI3), Taichong (LR3), Zusanli(ST36), Yanglingquan (GB34), contralateral to the operated leg and deqi sensation elicited at acupoints.
15831893|NCT04189224|Device|JJV Investigational Multifocal Contact Lens|TEST
15831894|NCT04189224|Device|1-Day Acuvue® Moist Brand Multifocal Contact Lens|CONTROL
15831895|NCT04189211|Drug|BAT8001|IV infusions.
15831896|NCT04189198|Drug|Articaine|Supraclavicular block with 30 ml articaine 2%
15831897|NCT04189198|Drug|Bupivacaine|Supraclavicular block with 30 ml bupivacaine 0.5%
15831898|NCT04189185|Procedure|Suture fixation|The fracture is reduced. A 2.5 mm hole is drilled in the dorsal olecranon 15mm from the fracture. A suture is passed through the hole and is fixed to the triceps muscle. A second suture is fixed to the triceps muscle in a figure 8 configuration.
15831899|NCT04189159|Behavioral|PROMPT|PROMPT treatment is consistent with the principles of motor learning, in that every session includes a blocked pre-practice followed by variable and distributed practice and a gradual, hierarchical increase of complexity. Speech motor goals are integrated in goals for language and functional communication. During a PROMPT session tactile-kinesthetic-proprioceptive inputs are consistently provided, in order to shape speech movements, to give information on sequencing and timing and to introduce constraints for the reduction of degrees of freedom at the articulators' level in favour of motor control.
15831900|NCT04189146|Behavioral|Inner Engineering Intervention|"The intervention investigators propose for the study includes an Online Course with 7 modules, or a 10 hours long course, and a 1-2 day In-Person Course, in which participants will learn a simple 21 minute practice called Shambhavi Mahamudra Kriya, also known as Shambhavi Kriya.
~Shambhavi Kriya is a powerful and purifying energy technique incorporating the breath. This practice is said to align the participants system such that their body, mind and emotions function in harmony."
15831901|NCT04189133|Drug|Lutropin alfa|daily increasing dosages of lutropin alfa
15831902|NCT04189133|Drug|Human chorionic gonadotropin|human chorionic gonadotropin increasing administration
15831903|NCT04189120|Procedure|Thoracic epidural analgesia , superficial serratus plane block and deep serratus plane block|neuroaxial thoracic epidural analgesia and regional analgesia supeficial and deep serratus plane blocks
15831904|NCT04189107|Drug|Dexamethasone|High-dose dexamethasone peroperative and postoperative on day 2 and 4
15831905|NCT04189107|Drug|Placebo|low dose dexamethasone peroperative and placebo postoperatively on day 2 and 4
15831906|NCT04189094|Drug|Sintilimab|Etoposide and cisplatin (carboplatin) plus Sintilimab induction therapy will be administered for 2 cycles and then thoracic radiotherapy (45 Gy/30 fractions) be administered with concurrent EP/EC chemotherapy for 2cycles. Patients who achieve CR or PR then receive prophylactic cranial irradiation (PCI, 25 Gy/10 fractions).Sintilimab maintenance therapy will be administered once every 3 week for 13 cycles.
15831907|NCT04189094|Drug|Etoposide|Etoposide will be administered IV 100mg/m2 on days 1-3, 22-24, 43-45 and 64-66.
15831908|NCT04189094|Drug|Cisplatin|cisplatin will be administered IV 80mg/m2 on days 1, 22, 43 and 64.
15831909|NCT04189094|Radiation|radiotherapy|Thoracic radiotherapy (45 Gy/30 fractions) and prophylactic cranial irradiation (25 Gy/10 fractions).
15831910|NCT04189081|Device|dry mouth rinse|relieves dry mouth symptoms by physically coating oral mucosal surfaces.
15831911|NCT04189081|Other|Water Control|negative control
15831912|NCT04189055|Drug|Cetuximab|Cetuximab 500mg/m² IV, day 1
15831913|NCT04189055|Drug|Irinotecan|Irinotecan 180mg/m² IV, day 1
15831914|NCT04189029|Other|Extensive phenotyping|Prospective assessment of physical evaluation, biomarkers and omics, cardiac and vascular imaging and telemonitoring of cardiovascular parameters for 14 days.
15831915|NCT04189016|Device|Inhalation from a salt particle inhaler with or without content|Inhalation from inhaler with (active) or without (placebo) content
15831916|NCT04188990|Dietary Supplement|Nutritional dietary intervention|The intervention will be carried out by the Endocrinology and Nutrition Service of hospital 1, where the type of therapeutic action to be developed will be established (Dietary advice, Oral Nutritional Supplementation (SNO), Enteral Feeding or Parenteral Nutrition). The Total Calorie Balance, calories from feeding or with Oral Nutritional Supplementation (ONS), enteral, parenteral, and protein intake will be recorded. The steps to be taken are the following: A.-In patients with preserved oral intake capacity apply the most appropriate dietary measures in each case. B.-If the oral route is contraindicated, it will be assessed if it is possible to use the gastrointestinal tract and enteral nutrition will begin until the patient recovers the oral intake capacity. C.-If the use of the gastrointestinal tract is not indicated, parenteral nutrition will be assessed until digestive function is restored.
15831917|NCT04188990|Dietary Supplement|By demand|"In the By demand arm, it is by clinical judgement of the doctor responsible of each patient that can be demanded a nutritional intervention to the nutrition unit of the center's endocrinology service that will judge the type of intervention. This is their usual care right now"
15831918|NCT04188990|Dietary Supplement|Usual current care|"In th Usual care arm, there is no explicit nutritional intervention performed at this time for those patients and, therefore, their usual regular nutritional care will be provide"
15831919|NCT04188977|Other|Usual Practice|OTP Directors are able to ask their state health officials permission to use interim methadone treatment. The state officials are in turn able to ask officials from the Center of Substance Abuse Treatment for permission to provide interim methadone treatment.
15831920|NCT04188977|Other|Implementation Facilitation|Implementation Facilitation (IF) will consist of educational outreach to OTP staff, identification of local champions, training, performance feedback, and learning collaborative for OTP staff and state health department officials.
15831921|NCT04188964|Drug|Burosumab|Burosumab is a sterile clear colourless and preservative free solution supplied in single use 5ml vials containing 1 mL of Burosumab at a concentration of 10mg/mL,20 mg/mL or 30mg/mL, administered by SC injections every 2 weeks.
15831922|NCT04188951|Drug|Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]|Patients will receive 17 cycles of pembrolizumab via IV infusion of 200 mg over a period of 30 minutes, every 3 weeks starting no later than 90 days from the date of salvage head and neck therapy.
15831923|NCT04188938|Other|Evaluation of occult pneumothorax in who had a blunt or penetrating chest trauma|
15831924|NCT04188925|Device|Laser Acupuncture|"The LA is using a gallium aluminum arsenide LaserPen (maximal power, 150 mW; wavelength, 810nm; area of probe, 0.03cm2; power density, 5W/cm2; pulsed wave; RJ-Laser, Reimers & Janssen GmbH, Waldkirch, Germany). The LA treatment will be applied to EX-LE5, ST35, and BL40 for 80 seconds, under power 150mW, to deliver a total treatment dose of 6 Joule/ cm2.
~The EA is the combination of acupuncture and transcutaneous electrical nerve stimulator. The transcutaneous electrical nerve stimulator is produced by Ching Ming Medical Device Company. This machine is verified by Department of Health in Taiwan, with the ID number 001147. We perform acupuncture on GB33, GB34, SP9, SP10, and ST36."
15831925|NCT04188925|Device|Sham Laser Acupuncture|Sham LA is using the same appearance of LaserPen without energy output to perform the same acupoint as above description. Both of the LaserPen in two groups are labeled with A and B, one of them is revised by the company to become the sham LA. The outward of both LaserPen are the same and our physician does not know which one is the real.
15831926|NCT04188912|Procedure|Biospecimen Collection|Undergo collection of blood, tears, saliva, buccal mucosa, feces, and tissue samples
15831927|NCT04188912|Procedure|Optical Coherence Tomography|Undergo optical coherence tomography
15831928|NCT04188912|Procedure|Spirometry|Undergo portable spirometry
15831929|NCT04188912|Other|Survey Administration|Complete survey
15831930|NCT04188912|Other|Digital Photography|Undergo digital photography
15831931|NCT04188912|Other|Quality-of-Life Assessment|Ancillary studies
15831932|NCT04188912|Other|Medical Chart Review|Review of medical charts
15831933|NCT04188886|Other|Practice survey|Practice survey on
15831934|NCT04188873|Drug|Preparation Varenicline and Standard Duration Varenicline|16 weeks of varenicline starting 4 weeks pre-quit
15831935|NCT04188873|Drug|Preparation Varenicline and Extended Duration Varenicline|28 weeks of varenicline starting 4 weeks pre-quit
15831936|NCT04188873|Drug|Standard Duration Varenicline|12 weeks of varenicline
15831937|NCT04188873|Drug|Extended Duration Varenicline|24 weeks of varenicline
15831938|NCT04188873|Drug|Preparation Combination NRT and Standard Duration Combination NRT|16 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
15831939|NCT04188873|Drug|Preparation Combination NRT and Extended Duration Combination NRT|28 weeks of nicotine patch + nicotine mini-lozenge starting 4 weeks pre-quit
15831940|NCT04188873|Drug|Standard Duration Combination NRT|12 weeks of nicotine patch + nicotine mini-lozenge
15831941|NCT04188873|Drug|Extended Duration Combination NRT|24 weeks of nicotine patch + nicotine mini-lozenge
15831942|NCT04188873|Behavioral|Intensive Counseling|4 phone or video counseling sessions
15831944|NCT04188860|Drug|A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel|"A combination of anti-PD-1 antibody camrelizumab and albumin-bound paclitaxel would be given for all patients:
~Camrelizumab: 200 mg every time, every 3 weeks, which would be sustained until the appearance of disease progression on intolerable adverse events, and no more than 24 months
~Albumin-bound paclitaxel: 200-300 mg every time, every 3 weeks, no more than 6 courses"
15831945|NCT04188847|Drug|Chemotherapy plus apatinib|"A combination of cisplatin, paclitaxel and apatinib would be given for all patients:
~Cisplatin: 50 mg/m2 body surface area, on the first day, every 3 weeks. If the creatinine clearance rate was less than 40 ml/min, the cisplatin would be replace by carboplatin (area under ther curve = 5)
~Paclitaxel: 50 mg/m2 body surface area, on the first day, every 3 weeks
~Apatinib: 250 mg every day The total courses of cisplatin and paclitaxel would be no more than 6."
15831946|NCT04188834|Device|Customized version of DAVID device|A customized version of the DAVID device will be used to expose patients to sensory flicker. The device consists of opaque glasses containing LEDs to present flickering light, as well as earbuds or headphones to present flickering sound.
15831947|NCT04188834|Device|CereStim R96|The CereStim R96 is a fully programmable neurostimulator. The current pulses generated by the CereStim R96 are intended to stimulate neurons in proximity to a set of electrodes.
15831948|NCT04188821|Procedure|breast drain removal|"Investigators remove the drains when the suction drain flow was less than 30 ml/day for at least 2 days or at discharge, with no further signs of infection, fluid collection or impaired wound healing (complicated, see below). Ultimately, we removed drains 3 weeks postoperatively (21 days post op) even if the flow was higher than 30 ml/day. However, leakage or severe patient discomfort led to immediate drain removal at any time during postoperative care."
15831949|NCT04188808|Other|Bypass surgery|All patients scheduled for elective surgery of PAA and PAD.
15831950|NCT04188795|Procedure|Delirium Preventive Care Protocol|"Nursing care was applied to hip fracture patients in the experimental group in accordance with the care protocol developed to prevent delirium. Delirium preventive care protocol was consist of; psychosocial care, monitoring of oxygen saturation, prevention of dehydration, nutritional support, normal elimination, pain control, sleep regulation, avoidance of bladder catheterization and early mobilization.
~Confusion Assessment Method, Barthel Index and Richards-Campbell Sleep Questionnaire were repeated to patients on the first postoperative day and on the third day."
15831951|NCT04188782|Drug|Sevoflurane|Describe how a reiterative anesthesia exposure could induce tolerance to the anesthetic.
15831952|NCT04188769|Device|constant deep pressure applied by an air splint|inflation of the Johnstone air splint gives a constant local deep pression on the hemiplegic arm
15831953|NCT04188769|Device|intermittent deep pressure applied by an air splint|continuous inflation and deflation of the Johnstone air splint gives an intermittent local deep pression on the hemiplegic arm
15831954|NCT04188769|Device|uninflated air splint|no deep pressure applied by the air splint
15831955|NCT04188769|Other|contralateral movement|non-hemiplegic arm is flexed and extended 5 times, with a weight of 5kg in the hand, in order to trigger hypertonia in the hemiplegic arm
15831956|NCT04188756|Other|Exercise|High intensity interval training (rehabilitation) over 15 weeks. Patients will be guided by physicians for exercise training in Pulmonary hypertension
15831957|NCT04188743|Biological|Allogenic FMT|Transplantation of fecal microbiota from a donor into a recipient
15831958|NCT04188743|Biological|Autologous FMT|Transplantation of autologous fecal microbiota
15831959|NCT04188730|Drug|Lofexidine (granules for reconstitution)|All subjects will be administered one 0.36 mg dose of lofexidine granules for reconstitution.
15831960|NCT04188730|Drug|LUCEMYRA (lofexidine) tablets|All subjects will be administered one 0.36 mg dose of LUCEMYRA (lofexidine) tablets.
15831961|NCT04188704|Procedure|Interference screw|Anterior cruciate ligament reconstruction (anterior screw fixation or posterior screw fixation)
15831962|NCT04188691|Biological|Norovirus Bivalent (GI.1 / GII.4) Vaccine（low）|Norovirus Bivalent (GI.1 / GII.4) Vaccine（low）administered intramuscularly according to a 0, 28，（56） day vaccination schedule
15831963|NCT04188691|Biological|Norovirus Bivalent (GI.1 / GII.4) Vaccine（middle）|Norovirus Bivalent (GI.1 / GII.4) Vaccine（middle）administered intramuscularly according to a 0, 28，（56） day vaccination schedule
15831964|NCT04188691|Biological|Norovirus Bivalent (GI.1 / GII.4) Vaccine（high）|Norovirus Bivalent (GI.1 / GII.4) Vaccine（high）administered intramuscularly according to a 0, 28，（56）day vaccination schedule
15831965|NCT04188691|Biological|Normal saline|Normal saline administered intramuscularly according to a 0, 28 ，（56）day vaccination schedule
15831966|NCT04188691|Biological|Aluminum adjuvant|Aluminum adjuvant administered intramuscularly according to a 0, 28，（56） day vaccination schedule
15831967|NCT04188678|Other|Bone Marrow Transplant (BMT)|Bone marrow transplantation will be conducted according to the investigators' institution's standard of care, or else according to research protocol (if applicable).Study visits that include the performance of assessments will occur prior to the start of conditioning chemotherapy and at 1 month and 6 months post-BMT. All dates are +/- 7 days. The initial study visit will take place during standard of care pre-transplant evaluations, which typically span 3-4 days. The post-BMT visits will take place before or after regularly-scheduled BMT follow up.
15831968|NCT04188665|Drug|MASL|Patients treated with MASL lozenge
15831969|NCT04188665|Other|Placebo|Patients treated with placebo lozenge
15831970|NCT04188652|Other|Detailed symptomregistration|Information on symptoms, specialized ultrasound in accordance to IOTA, and HE4 is registered in women with ovarian cysts. Participation in the study including symptom registration, description of the cyst using IOTA terminology, and HE4 determination will not affect further diagnostics or treatment. HE4 will not be informed to the patient or clinician.
15831971|NCT04188639|Drug|Emicizumab Injection|All eligible patients with AHA will receive the same study medication consisting of once weekly subcutaneous emicizumab. For each subject, the maximal duration of the study will be 24 weeks including 12 weeks treatment with emicizumab and 12 weeks Immunosuppressive therapy according to local standard of care.
15832011|NCT04188392|Drug|Pimavanserin|pimavanserin tablet
15832012|NCT04188379|Biological|efgartigimod|Intravenous infusion of efgartigimod
15832013|NCT04188379|Other|Placebo|Intravenous infusion of placebo
15831972|NCT04188626|Behavioral|Driving simulator sessions|The volunteers will be placed in a driving simulator that will simulate autonomous highway driving. This autonomous driving will be interrupted by take-over requests related to events that disrupt autonomous driving. During autonomous driving, the driver will have to disengage from driving by performing non-related driving tasks. During each non-related driving tasks, a take-over request will be sent. Electrophysiological (EEG, ECG, EDA, EMG, respiration) and behavioural data will be recorded before, during and after the take-over control.
15831973|NCT04188613|Device|Percutaneous tracheostomy|Age, gender, height, BMI, ASA scores, presence and type of additional diseases, tracheostomy day, pre- and post-procedure blood gas analysis, duration of procedure, duration of anesthesia, complications during the procedure (bleeding , desaturation, accidental extubation, malposition, bradycardia, hypotension, etc.) will be recorded from intensive care follow-up. Patients will be observed for mortality in the first 30 days after the procedure. Mortality results will be recorded.
15831974|NCT04188600|Dietary Supplement|Libicare|"The main ingredients of Libicare® are:
~Trigonella Foenum-graecum (Trigonella)
~Tribulus Terrestris (Tribulus)
~Turnera Diffusa (Damiana)"
15831975|NCT04188600|Dietary Supplement|active control|Selenium and vitamins B complex
15831976|NCT04188587|Drug|177 Lu-PSMA-I&T|All patients were intravenous injected with single dose 2.0-8.0 GBq. The time of the next treatment cycle is determined according to the patient's condition, and it is recommended to treat once every 8-12 weeks.
15831977|NCT04188574|Drug|BB2603-1|Treatment with topical spray twice-daily (BID) BB2603-1: 0.01% terbinafine
15831978|NCT04188574|Drug|BB2603-3|Treatment with topical spray twice-daily (BID) BB2603-3: 0.03% terbinafine
15831979|NCT04188574|Drug|BB2603-10|Treatment with topical spray twice-daily (BID) BB2603-10: 0.1% terbinafine
15831980|NCT04188574|Drug|Vehicle|0.3% polyhexanide/20% ethanol/water.
15831981|NCT04188561|Drug|Intra articular injection Group|"Patients included in the study had been received 2 ml high molecular weight (1.476 x 106 average Daltons) hyaluronic acid with concentration of 22mg/ml (OPTIVISC UK hyaluronic acid for intra articular injection). Platelet rich plasma is arranged by withdrawing 10 ml of patient's personal venous blood, anticoagulant is added, and centrifuged by duo-spin method, at the rate of 3500 rpm for five minutes then injected twice with 2 weeks interval. 3 distinct layers are produced by the end of the centrifugation: plasma, buffy coat (platelet) and RBCs, about 3 - 3.5 ml of PRP is produced
~at the end with platelet concentration of 1.4 - 1.6 million/μl on average."
15831982|NCT04188561|Device|Radiofrequency Group|Thermal radiation is done by Neurotherm 2000 (Neurotherm NT 2000 Radiofrequency (RF) Generator is a four electrode pain management (RF) generator for interventional pain management procedures. Neurotherm's newest system offers accurate independent controls of each electrode through the touch screen interface and output control knobs.), Patients from the radiofrequency (RF) group had been placed in the supine position and their knee will be supported by a small pillow placed beneath the popliteal fossa. Fluoroscopic images of knee joint had been obtained. Possible locations of genicular nerves had been determined on the lateral, medial aspects of the lower end of the femoral bone and on the medial aspect of the tibia, under fluoroscopic guidance.
15831989|NCT04188535|Diagnostic Test|MRI IMAGING|Imaging with MRI will be performed as per disease site standards.
15831990|NCT04188522|Diagnostic Test|Magnetoencephalography (MEG)|Participants will undergo MEG at the University of Maryland (College Park) to measure cerebral activity while performing a visual naming task. The Montreal Cognitive Assessment (MOCA) will also be administered.
15831991|NCT04188509|Drug|Voxelotor|All participants will receive voxelotor once daily (QD), administered orally as tablets, dispersible tablets, or a powder for oral suspension formulation (powder formulation packaged as stick packs).
15831992|NCT04188496|Other|Pulmonary Function Test group|The interventional group received the same conventional Chest physiotherapy Techniques for 30 minutes followed by 10 minutes rest. The patients then received additional 15 minutes protocol of thoracic joint mobilization
15831993|NCT04188496|Other|Control Group|received conventional Chest physiotherapy Techniques for 30 minutes (including deep breathing, diaphragmatic breathing exercises, Self-stretching exercises for accessory respiratory muscles, Respiratory Resistance training by incentive spirometer) followed by 10 min rest.
15831994|NCT04188483|Dietary Supplement|Selenium Supplementation|The selenium supplementation group will receive 200 μg selenium daily by taking two selenium-enriched yeast tablets (SelenoPrecise®, Pharma Nord) once daily for 60 days.
15831995|NCT04188483|Biological|Influenza vaccination|Subjects will receive standard seasonal influenza vaccination for the 2019-2020 season.
15831996|NCT04188470|Behavioral|person-centered care model|A multidisciplinary team (clinical pharmaceutical, expert physician on chronic management disease, and basic healthcare team) will review the frailty, complexity, the therapeutic goals of the patients to propose changes on the therapeutic plan to improve the appropriateness, these changes will we agreed with the patient or caregiver.
15831997|NCT04188457|Other|Usual follow-up|2 medical consultations (nurse and doctor) over 24 months
15831998|NCT04188457|Other|Intensive follow-up|10 medical visits (nurse, doctor, pharmacist) over 24 months
15831999|NCT04188444|Biological|Blood test|20 ml of blood, three times
15832000|NCT04188431|Drug|Dexamethasone|Is usually commercialized as dexamethasone phosphate as solution for injection
15832001|NCT04188431|Drug|Sodium chloride|prepared in the same intravenous volume to mimic experimental arm
15832014|NCT04188366|Behavioral|FAMES|Participants will receive three distinct and revolving components - early, continuous, and motivational contact - that incorporate motivational techniques and the Diagnostic and Statistical Manual of Mental Disorders 5TH Edition (DSM-5) Cultural Formulation Interview (CFI).
15832015|NCT04188366|Behavioral|Treatment-as-Usual|Participants will receive usual services and family-based treatment offered
15832016|NCT04188353|Device|Optic nerve sheath diameter measurement|ONSD measurements done at screening (T1), 30 minutes after mannitol infusion (T2), 60 minutes (T3) and 120 minutes (T4)
15832017|NCT04188353|Drug|Mannitol|Mannitol at dose of 0.25 to 1 gm/kg over 20 minutes via a dedicated IV line
15832018|NCT04188340|Behavioral|Su-Man formula massage oil|bergamot massage oil:dilute bergamot essential oil(0.5%) with almond oil Su-Man formula massage oil: mixed 4 different essential oil include bergamot, red mandarin, petit grain bigarade, spikenard and diluted with almond oil 5%.
15832019|NCT04188327|Procedure|Stellate ganglion block|"While the patient is in a supine position with slight neck extension and rotation to the contralateral side, in-plane ultrasound guided stellate ganglion block will be performed with injection of 7 ml injectate (6ml bupivicain 0.25%+ 1 ml methylpredinosolone 40mg).
~Each patient will receive:
~Acyclovir 800 mg orally every 5 times per day 7 days.
~Pregabalin start with 50 mg orally every 8hours for 7 days then increase to 150 mg every 12 hours"
15832020|NCT04188327|Procedure|Sham Stellate ganglion block|"The patient will be positioned supine with slight neck extension and rotation to the contralateral side. Under US guidance, a sham stellate ganglion block will be performed with injection of a 1ml injectate of normal saline will be done while observing the dissection between the carotid artery and the longus colli muscle.
~Each patient will receive:
~Acyclovir 800 mg orally every 5 times per day for 7 days.
~Pregabalin start with 50 mg orally every 8hours for 7 days then increase to 150 mg every 12 hours"
15832021|NCT04188314|Drug|Desflurane|The intervention group will receive desflurane for maintenance of anaesthesia, and the quality of recovery score will be compared post-operatively with the control group who received isoflurane.
15832022|NCT04188314|Drug|Isoflurane|The control group will receive Isoflurane for maintenance of anesthesia. The quality of recovery score will be compared post-operatively with patients in the intervention group who received desflurane.
15832023|NCT04188301|Drug|IVM w/ ALB|Participants will be given a single dose of oral IVM (150 µg/kg) plus ALB (400 mg) (IVM/ALB)
15832024|NCT04188301|Drug|Single dose of IDA|Participants will be given a single dose of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg)
15832025|NCT04188301|Drug|Three daily doses of IDA|Participants will be given one daily dose for 3 days of oral IVM (150 µg/kg), DEC (6 mg/kg) and ALB (400 mg)
15832026|NCT04188288|Device|Experimental feedback|Participants provided with feedback of target brain activation patterns (for example, in the form of a line graph) and will be instructed to try to make the line go up or down.
15832027|NCT04188288|Device|Control feedback|Participants provided with control type of feedback (for example, in the form of a line graph) and will be instructed to try to make the line go up or down.
15832028|NCT04188275|Diagnostic Test|Periodic ARV7 and miRNA evaluation|Determination of AR-V7 splice variants on circulating tumor cells and evaluation of circulating levels of miRNA by blood sample collection during PSA assessment at different time points along the treatment course (initiation, 8-weeks assessment, progression).
15832029|NCT04188262|Combination Product|NVS Therapy|Combination Product: NVS Therapy which includes NVS Injection (investigational product) and the following investigational devices: NVS Delivery Catheter, NVS light Fiber, and NVS light source.
15832030|NCT04188249|Drug|Golimumab|This multicenter (12 centers), prospective program will register 200 RA patients routinely receiving golimumab treatment. Doctor will record the disease evaluation, concomitant drug, adverse events and laboratory tests based on patient's visit till they withdraw from clinical visit. Doctor will still collect above information whether patient interrupt or stop golimumab till the end of program or patient withdraw permanently.
15832031|NCT04188236|Device|Hernia Blocking System|Hernia Blocking System device implanted during a lumbar discectomy procedure
15832032|NCT04188223|Biological|Recombinant Hepatitis B (Bio Farma) Vaccine|Recombinant Hepatitis B vaccine produced by Bio Farma
15832033|NCT04188223|Biological|Recombinant Hepatitis B (Bio Farma) Vaccine®|Registered Recombinant Hepatitis B vaccine produced by Bio Farma
15832034|NCT04188210|Other|Presence of elbow pain in patients with end stage renal disease|The Beck Depression Inventory (BDI), the Nottingham Health Profile (NHP) scores were measured for all patients to evaluate depression symptoms and health-related quality of life. The elbow pain presence was asked to all the patients, the patients with elbow pain were also evaluated with The Disabilities of the Arm, Shoulder and Hand Score (Q-DASH) and Visual Analogue Scale (VAS). VAS detected as pain during rest, activity, night and pain at last week.
15832035|NCT04188197|Other|JUUL|Subjects will be instructed to use the JUUL as often as they like during the 12-week product use period. They will also be instructed to use JUUL immediately before each cigarette to relieve their craving as much as possible before smoking their usual brand. The JUUL will also be the first product that they are instructed to use each morning. Smokers will be told to try to completely substitute JUUL for cigarettes by the end of the first week of use.
15832036|NCT04188184|Drug|Tranexamic Acid|received topical 1 gram of TXA diluted in 200 ml of normal saline (0.9%) for topical use to rinse the bleeding sites and soak the used gauze for local compression.
15832037|NCT04188184|Drug|Epinephrine|received Epinephrine 1 mg diluted in 200 ml normal saline (0.9%) for topical use to rinse the bleeding sites and soak the used gauze for local compression.
15832038|NCT04188171|Procedure|Polidocanol foam sclerotherapy|"Preparation of the foam is done according to the Tessari technique (2 disposable 20ml syringe, a three-way tap, reusable extender adapted to intravenous needle).
~Sclerosant applied according to the Blanchard technique through a disposable transparent anoscope (patient in knee-chest position).
~In each session, treatment can be performed on more than one hemorrhoidal cushion. The maximum dose per treatment session is 20ml (mixture of 4ml of polidocanol 3% with 16ml of air).
~During the intervention period the participants are observed at 3-week intervals. The required number of sessions (maximum of 3) is determined by clinical and anoscopic evaluation.
~After the intervention period, a one-year follow-up is scheduled with medical appointments performed every 3 months."
15832039|NCT04188158|Combination Product|CAPECITABINE AND OXALIPLATIN|Intervention Group: Neoadjuvant chemotherapy ( 3 cycles Capecitabine and oxaliplatin) + surgery + adjuvant chemotherapy (5 cycles Capecitabine and oxaliplatin)
15832042|NCT04188132|Other|EEG -BCI based Feedback for rehabilitation|Subjects will undergo EEG based BCI as feedback for rehabilitation
15832043|NCT04188119|Drug|Avelumab|(Arm A) Avelumab + Proto Pump Inhibitor (PPI)
15832044|NCT04188119|Drug|Aspirin|300mg tablets
15832045|NCT04188119|Drug|Lansoprazole|30mg
15832046|NCT04188106|Drug|Varenicline Pill|FDA approved starter kit of varenicline (0.5 mg nightly for days 1-3, then 0.5 mg twice daily for days 4-7) followed by FDA-approved dose of varenicline (1 mg twice daily) for the remaining 11 weeks
15832047|NCT04188106|Drug|Hydroxyzine Pill|For the first week, participants will receive 50 mg nightly for the first 3 days, then twice daily, 25 mg in the morning and 50 mg at night for the remaining 12 weeks.
15832048|NCT04188093|Other|PACU discharge criteria and continuous monitoring on the ward|"PACU discharge criteria (modified aldrete score).
~Continous monitoring of vital signs 96 postoperative hours"
15832049|NCT04188080|Dietary Supplement|Jarlsberg Cheese|Oral daily intake of Jarlsberg cheese
15832050|NCT04188067|Device|ACTIVE rTMS|All study participants will receive one block of ACTIVE rTMS. Each block will consist of daily sessions of active rTMS delivered to the left dorsolateral prefrontal cortex over ten days (Monday through Friday).
15832051|NCT04188067|Device|SHAM rTMS|All study participants will receive one block of SHAM rTMS. Each block will consist of daily sessions of SHAM rTMS delivered to the left dorsolateral prefrontal cortex over ten days (Monday through Friday).
15832052|NCT04188054|Behavioral|Change in sleeping position|The new sleeping position requires you to re-position yourself in your bed when lying on your back so that your feet (and ankles) hang over the end of the mattress, i.e. off the end of the bed.
15832053|NCT04188054|Behavioral|No change in sleeping position|No change to your normal sleeping position
15832054|NCT04188041|Other|TB Infection ECHO|A six-month virtual telementoring course regarding TB infection testing and treatment that incorporates didactics, case presentation, and discussion
15832055|NCT04188028|Drug|Dextromethorphan 5 MG|dextromethorphan 5 mg po
15832056|NCT04188028|Drug|Paroxetine 10Mg Tablet|Paroxetine 10 mg po
15832057|NCT04188028|Drug|Paroxetine 20Mg Tablet|Paroxetine 20 mg po
15832058|NCT04188015|Biological|2.5mg ANX007|A single dose of 2.5mg ANX007 will be administered via IVT injection into the study eye at Day 1 and Day 29.
15832059|NCT04188015|Biological|5.0mg ANX007|A single dose of 5.0mg ANX007 will be administered via IVT injection into the study eye at Day 1 and Day 29.
15832060|NCT04188015|Other|Sham Procedure|The sham injection is preformed by applying pressure to the eye at the location of a typical IVT injection using the blunt end of a syringe without a needle.
15832061|NCT04188002|Behavioral|Intervention Physical Activity|4 tailored newsletters focused on improving healthy diet and physical activity delivered at weekly intervals.
15832062|NCT04188002|Other|Usual Care|4 non-tailored newsletters focused on issues relevant to cancer survivors (e.g. returning to work)
15832063|NCT04187989|Behavioral|Social Media Intervention|Information will be posted by e-coaches. You can interact with the e-coaches as well as other study members in your group.
15832064|NCT04187963|Other|Physical therapy|"The rehabilitation protocol for the IPT consisted of cardiovascular warm-up activities, stretching exercises, strengthening exercises, functional, gait and balance training, recreational games and ended with relaxation exercises. In addition, the GPT protocol followed the exact same pattern, except for 5-10 minute breaks for informal socialization between participants, at the beginning of the session, mid-session and at the end of the session.
~Also, both groups had access to external cues, which were applied during a variety of tasks and environmental situations, like gait initiation and termination, heel strike and push-off, sideways and backwards stepping, walking while dual tasking, and walking over various surfaces and long distances."
15832065|NCT04187950|Dietary Supplement|Yogurt with B. lactis and added honey|The intervention condition will utilize a commercially available yogurt (Activia) that contains Bifidobacterium animalis lactis DN-173 010/CNCM I-2494 (B. lactis). Participants will consume 170 g of yogurt with honey twice daily for 14 days.
15832066|NCT04187950|Dietary Supplement|Yogurt with heat-inactivated B. lactis and added cane sugar|The control condition will utilize a commercially available yogurt (Activia) following heat inactivation of the probiotic Bifidobacterium animalis lactis DN-173 010/CNCM I-2494 (B. lactis). Participants will consume 170 g of the heat-inactivated yogurt with added cane sugar twice daily for 14 days.The added cane sugar will be an isocaloric amount to the honey.
15832067|NCT04187937|Device|Stereotactic image-guided resection|Stereotactic image-guided resection with an ultrasound-based image-guidance system.
15832068|NCT04187924|Other|Autogenic drainage|Autogenic drainage is an airway clearance technique characterised by breathing control using expiratory airflow to mobilise secretions from smaller to larger airways. The secretions will be collected during the physiotherapy session and during the 24 hours following the session.
15832069|NCT04187924|Device|SIMEOX + Autogenic drainage|SIMEOX is a device generating a succession of gentle depression at the mouth during the expiratory phase associated with autogenic drainage.
15832097|NCT04187677|Procedure|Sensory Training|The sensory training group includes sensory-oriented interventions and exercises unlike the other classical hand therapy group.
15832098|NCT04187677|Other|classical hand therapy|classical hand therapy
15832099|NCT04187664|Behavioral|Postoperative Monitoring|Nursing and medical staff will monitor patients vital signs and clinical deterioration triggers twice as often as in previous ward care.
15832100|NCT04187664|Diagnostic Test|High-sensitivity cardiac troponin testing|High-risk patients will have their high-sensitivity cardiac troponin tested preoperatively and daily for the first 48h postoperatively
15832101|NCT04187651|Other|platelet rich plasma|platelet rich plasma prepared from the patients' own blood will be applied to the fistula tract
15832070|NCT04187911|Behavioral|Dyadic Developmental Psychotherapy (DDP)|DDP involves approximately twenty 1 hour sessions (usually over 6-9 months) with the adoptive parent/foster carer and child, facilitated by a specifically trained therapist. The role of the therapist during sessions is to maintain an attuned relationship with both child and parent - modelling and encouraging development of a similarly attuned relationship between the child and parent. Therapists are trained to use Playfulness, Acceptance, Curiosity and Empathy (PACE). Our research suggests that key mechanisms of action in DDP might include the active participation of the parents and increased carer empathy and emotional warmth for the child. DDP experts believe this helps build parental capacity for attuned dialogue with the child, co-creation of the meanings underlying child behaviour, and co-regulation of experienced emotions aiming to address four main problem areas: 1. child emotional regulation 2. parental stress 3. the parent-child relationship 4. child mental health.
15832071|NCT04187911|Behavioral|Services as Usual (SAU)|"SAU tends to be case-dependent with therapists and social workers attempting to respond to the sometimes changeable needs of the family as needs arise. At the time of our UK mapping and modelling work, these services were usually CAMHS based. This may have changed, at least for adoptive families, with the advent of the Adoption Support Fund, which, since May 2015, has allowed local authorities / adoption agencies to apply for funding for essential therapeutic services. A wide range of interventions, many with a scant evidence base, have been purchased - sometimes from private practitioners - since 2015. In addition, relevant NICE guidelines, particularly those on Looked After and Accommodated Children, Attachment and Child Abuse and Neglect, have been published or updated.Our detailed qualitative and quantitative process evaluation throughout all study Phases will be crucial to carefully characterise SAU in all study sites."
15832072|NCT04187898|Drug|Eflapegrastim|"Administered in Cycle 1, 30 minutes after TC chemotherapy.
~Administered in Cycle 2-4, on day 2 of each cycle."
15832073|NCT04187898|Drug|Eflapegrastim|"Administered in Cycle 1, 3 hours after TC chemotherapy.
~Administered in Cycle 2-4, on day 2 of each cycle."
15832074|NCT04187898|Drug|Eflapegrastim|"Administered in Cycle 1, 5 hours after TC chemotherapy.
~Administered in Cycle 2-4, on day 2 of each cycle."
15832075|NCT04187898|Drug|Docetaxel|"75 mg/m^2 IV infusion.
~Administered on Day 1 of each cycle."
15832076|NCT04187898|Drug|Cyclophosphamide|"600 mg/m^2 IV infusion.
~Administered on Day 1 of each cycle."
15832077|NCT04187885|Behavioral|Group/Cohort 2: PAP|"Each experimental session will be carried out over 5 days of a week. Adolescents will take part randomly in four sessions.
~Physical activity program will be identical between sessions and groups. 60 min of moderate to vigorous leisure activities and exercises will be proposed each day. Heart rate monitor will be used to control intensity of exercise during the physical activity program."
15832078|NCT04187872|Combination Product|LITT + Pembrolizumab|Each patient will undergo brain biopsy and laser interstitial thermotherapy (LITT). As soon as possible, no later than two weeks after LITT, pembrolizumab will be administered via infusion and continue q3wks for up to two years.
15832079|NCT04187859|Behavioral|Education Session|Participants will receive an education session from their District Nurse, advising on how to improve their hydration.
15832080|NCT04187859|Device|Prompting Cup|The Droplet Cup is an electronic prompting cup that emits a sound and/or light to encourage the participant to take a drink
15832081|NCT04187833|Drug|Nivolumab|480mg intravenously every 4 weeks (28 days)
15832082|NCT04187833|Drug|Talazoparib|1mg orally daily
15832083|NCT04187820|Other|acupuncture|Patients receiving acupuncture and mild moxibustion, whom were treated 3 times per week for 12 weeks and followed up for 36 weeks. CV12 and Bilateral ST37, SP6, SP4, LR3, KI3, LI4 and LI11 were selected for acupuncture and bilateral ST25 and ST36 were selected for moxibustion. In the acupuncture group, Hwato acupuncture device was used to blind the subjects, and had the deqi sensation. The surface temperature of acupoints was maintained at 43℃± 1℃ for moxibustIon.
15832084|NCT04187807|Drug|Melatonin 5 mg|Placebo
15832085|NCT04187794|Other|Interview patient|to investigate an association between literacy level and medication adherence in patients with rheumatic diseases.
15832086|NCT04187781|Device|external microphone|External microphone is developed for direct transmission of speech into the hearing aids for better speech intelligibility, especially in noise.
15832087|NCT04187755|Drug|Ceftazidime Injection|Ceftazidime was administered intravenously with usual standard dose for serious infection (50 mg/kgBW/dose, 6 hourly)
15832088|NCT04187755|Drug|Cefepime Injection|Cefepime was administered intravenously with usual standard dose for serious infection (50 mg/kgBW/dose, 8 hourly)
15832089|NCT04187742|Behavioral|Social Comparison Email vs. Standard Email|Evaluate whether emails with social comparison incentives will encourage greater report opening by physicians leading to greater reductions in antibiotic use, than a standard email without social comparison incentives
15832090|NCT04187742|Behavioral|Maintenance Certification Email vs. Standard Email|Evaluate whether emails with maintenance certification incentives will encourage greater report opening by physicians leading to greater reductions in antibiotic use, than a standard email without social comparison incentives
15832091|NCT04187742|Behavioral|Report Opening Status Email vs. Standard Email (among previous report openers and non-openers)|Evaluate whether emails informing physicians of their report opening status (among those who have previously opened at least one report and those who have never opened a report) will encourage greater report opening by physicians leading to greater reductions in antibiotic use, than a standard email without report opening status information
15832092|NCT04187716|Drug|Ferinject|"For patients undergoing chemotherapy, ferinject 1000mg will be injected within 24 hours or 24 hours after day 1 of the next chemotherapy cycle.
~Patients using targeted therapies can be dosed at any time after recognizing Hb 8.0-10.5g / dL and injecting 1000 mg of ferinject."
15832093|NCT04187703|Drug|5-azacytidine|5-azacytidine 50 mg/m^2 Day 1 every week ± G-CSF ~5 µg/kg (300µg vs 480µg)
15832094|NCT04187703|Drug|Decitabine|Decitabine 5 mg/m^2 Day 4 every week ± G-CSF ~5 µg/kg (300µg vs 480µg)
15832095|NCT04187690|Drug|Jin-shui Huan-xian granule|Jin-shui Huan-xian granule will be administered 5days on and 2 days off for 52 weeks.
15832096|NCT04187690|Drug|Jin-shui Huan-xian granule placebo|Jin-shui Huan-xian granule placebo will also be administered 5days on and 2 days off for 52 weeks. The placebo consists 5% of the same components as Jin-shui Huan-xian granule besides dextrin and bitter. The There is no obvious difference in appearance, weight and odor between Jin-shui Huan-xian granule and placebo.
15832102|NCT04187638|Dietary Supplement|Olive oil|Participants will be randomly allocated to receive daily dose of 30ml of olive oil (OO) as intervention group or a matching control (butter 30g) for 2 weeks each (i.e. two weeks olive oil and two weeks butter), separated by a washout period of 2 weeks between treatments.
15832103|NCT04187638|Dietary Supplement|Butter|Participants will be randomly allocated to receive daily dose of 30ml of olive oil (OO) as intervention group or a matching control (butter 30g) for 2 weeks each (i.e. two weeks olive oil and two weeks butter), separated by a washout period of 2 weeks between treatments.
15832104|NCT04187625|Biological|endothelial progenitor cell|Kidney-derived endothelial progenitor cells will be delivered percutaneously to the kidney blood supply.
15832105|NCT04187612|Device|Bioelectrical Impedance Analysis (BIA)|BIA will be used to determine total body water
15832106|NCT04187599|Device|Paragon CRT®100 Contact Lens|Paragon CRT® 100 Contact Lenses for Corneal Refractive Therapy are indicated for use in the reduction of myopic refractive error in nondiseased eyes.
15832107|NCT04187586|Other|Extracorporeal shock wave therapy|ESWT was performed around the primary treatment site at 100 impulses/cm2, an energy flux density(EFD) of 0.05 to 0.30 mJ/mm2, frequency of 4Hz, and 1000 to 2000 impulses were administered at 1-week intervals for 6 sessions.
15832108|NCT04187573|Device|Neqstent|Adjunctive device providing stable aneurysm neck coverage for the placement of embolization coils within the aneurysm sac and long term stable occlusion of the aneurysm.
15832109|NCT04187560|Drug|LB-102|(N-Methyl amisulpride)
15832110|NCT04187547|Drug|Tricaprilin|"Powder formulation will be mixed with 240 mL water and shaken until fully dispersed.
~Each dosing unit of AC-SD-03 contains 20 g of the active ingredients (tricaprilin)"
15832111|NCT04187547|Drug|Placebo|Matching placebo to AC-SD-03 will be mixed with 240 mL water and shaken until fully dispersed.
15832112|NCT04187534|Other|Albumin Fluid Resuscitation Optimization Intervention|Multi-faceted quality improvement intervention to optimize appropriateness of albumin use for fluid resuscitation
15832113|NCT04187534|Other|Usual Practice|Albumin fluid resuscitation according to usual practice
15832114|NCT04187521|Other|Meal A|A breakfast meal with a specific macronutrient proportions.
15832115|NCT04187521|Other|Meal B|A breakfast meal with a specific macronutrient proportions.
15832116|NCT04187508|Drug|AZD8154 nebulizer suspension, 20 mg/mL|Subjects will receive AZD8154 from Day 1 to Day 10 (10 consecutive days) by using nebulizer and dosimeter system as inhaled dosing and delivered dose will be 3mg.
15832117|NCT04187508|Drug|Placebo|Subjects will receive AZD8154 matching placebo (placebo nebulizer suspension, glucose solution for infusion 50 mg/mL) QD from Day 1 to Day 10 (10 consecutive days) by using nebulizer and dosimeter system as inhaled dosing.
15832118|NCT04187495|Drug|MAX-40279-01|"Part 1: Dose escalation, MAX-40279-01 twice daily with dose modifications based on tolerability criteria.
~Part 2: Dose expansion, Recommended doses from Part 1.
~For each dose level, a single dose of MAX-40279-01 will be first administered orally followed by 1 day observation, then continuous treatment will start 4 weeks treatment (per cycle)."
15832119|NCT04187482|Other|Exercise training|All participants with DM1 will undergo a 12-week aerobic exercise training intervention on a cycle ergometer
15832120|NCT04187469|Drug|Moxifloxacin, Isoniazid, Rifampicin|"Moxifloxacin 400 mg/day, Rifampicin ≤50 kg 450 mg/day > 50 kg 600 mg/day, Isoniazid 300 mg/day.
~All treatment is taken daily, for a duration of up to 6 months depending on treatment arm."
15832121|NCT04187469|Drug|Rifampicin,Isoniazid,Pyrazinamide,Ethambutol|"Rifampicin ≤50 kg 450 mg/day, >50 kg 600 mg/day, Isoniazid 300 mg/day, Pyrazinamide 1500mg/day, Ethambutol ≤50 kg or the elderly 750mg/day, >50 kg 1000mg/day.
~All treatment is taken daily, for a duration of up to 26 weeks depending on treatment arm."
15832122|NCT04187456|Drug|Savolitinib|Single dose (together with midazolam) on Study Day 5 after a high fat, high calorie breakfast.
15832123|NCT04187456|Drug|Midazolam|Single dose (alone) on Study Day 1 and single dose (together with savolitinib) on Study Day 5, both after a high fat, high calorie breakfast.
15832124|NCT04187443|Drug|MS-553|MS-553
15832125|NCT04187430|Behavioral|Retrospective|Those patients with a positive sample for ICD will be randomly selected from the microbiology database.
15832126|NCT04187430|Behavioral|Prospective|After the routine identification of a case of DCI by the microbiology laboratory, those new cases will be included in the study.
15832127|NCT04187417|Drug|topical tetracaine hydrochloride 1%|topical ophthalmologic anesthestic
15832128|NCT04187417|Drug|Placebo|Placebo
15832129|NCT04187404|Biological|EO2401|Multiple dose of EO2041 in combination with nivolumab
15832130|NCT04187391|Device|Active tDCS|Active tDCS anode is applied over the left DLPFC with the cathode over the right supraorbital region.
15832131|NCT04187391|Device|Placebo tDCS|Placebo tDCS is applied but the current is turned off 10 seconds after the beginning and turned on for the last 10 seconds of the stimulation period.
15832132|NCT04187391|Behavioral|Language training|patients receive language training
15832133|NCT04187391|Behavioral|Unstructured cognitive training|patients receive unstructured cognitive training.
15832134|NCT04187378|Device|Surgical Underbody Blanket|Surgical blanket is used to maintain normothermia during abdominal surgery
15832135|NCT04187378|Device|Surgical access blanket|Surgical blanket is used to maintain normothermia during abdominal surgery
15832136|NCT04187365|Other|Duration of Indwelling Catheter|Foley catheter
15832137|NCT04187352|Drug|CS1001+ Fluorouracil+Cisplatin|"CS1001 1200 mg, intravenous infusion on the first day of each cycle (3 weeks) (Q3W).
~Fluorouracil: 800 mg/m2/day, continuous intravenous infusion on Day 1 to Day 4 of each cycle Cisplatin: 80 mg/m2, intravenous infusion on the first day of each cycle."
15832138|NCT04187352|Drug|Placebo+ Fluorouracil+Cisplatin|"Placebo 1200 mg, intravenous infusion on the first day of each cycle (3 weeks) (Q3W).
~Fluorouracil: 800 mg/m2/day, continuous intravenous infusion on Day 1 to Day 4 of each cycle Cisplatin: 80 mg/m2, intravenous infusion on the first day of each cycle."
15832139|NCT04187339|Biological|NGM395|NGM395 Dose 1
15832140|NCT04187339|Biological|NGM395|NGM395 Dose 2
15832141|NCT04187339|Biological|NGM395|NGM395 Dose 3
15832142|NCT04187339|Biological|NGM395|NGM395 Dose 4
15832143|NCT04187339|Biological|NGM395|NGM395 Dose 5
15832144|NCT04187339|Biological|NGM395|NGM395 Dose 6
15832145|NCT04187339|Other|Placebo|Placebo
15832146|NCT04187326|Behavioral|Facial Microexpression Training|The METT is a well-validated task designed to improve perception of subtle changes in facial expressions, termed microexpressions. Participants with high trait anxiety will return to the lab approximately six months post scan visit to complete this computer-based task. They will receive feedback during the task on their accuracy.
15832147|NCT04187313|Other|INSTEP2 intervention package|"The Intervention will comprise: An electronic notification system, a standardized education about the signs and symptoms of TB and TB management and an individualised plan for each PP with respect to their approach to the diagnosis and management of TB suspects.
~The electronic system is a refinement of the electronic referral and report-back system using a mobile phone 'app'. The system will enable essential data to be uploaded, consistent with National TB Control Programme forms.
~The education package will be focused on TB suspect identification, provisional diagnosis and referral, including how to use the mobile phone 'app'. We will also develop a simple individualised approach for the management of TB suspects, which takes into account the context around each PP's practice, identifying the most efficient and feasible approach to obtaining a diagnosis and notifying TB patients."
15832148|NCT04187300|Drug|Semaglutide|Increasing doses of semaglutide administered s.c. (subcutaneouly, under the skin) once weekly for 20 weeks
15832149|NCT04187287|Other|Radial Extracorporeal Shock Wave Therapy|Radial Extracorporeal Shock Wave Therapy will given for 3 weeks, 1 days in a week. moreover 10-12 minutes cold pack will apply for every session
15832150|NCT04187287|Other|Deep Friction Massage|Deep Friction Massage will given for 3 weeks, 3 days in a week. Massage duration will be 10-15 min. for each session. Moreover 10-12 minutes cold pack will apply for every session. Also Mill's manipulation technique will applied once a week during 3 weeks.
15832151|NCT04187274|Device|IKORUS technology|Ikorus technology is a new micro perfusion device measuring via urethral photoplethysmography, the urethral perfusion index (uPI) in patients equipped with an urinary catheter.
15832152|NCT04187261|Procedure|hip fracture surgeries|fixation or replacement
15832153|NCT04187248|Drug|Asparaginase|
15832154|NCT04187235|Procedure|Laparascopic repair of parastomal hernia|Laparascopic repair of parastomal hernia
15832155|NCT04187222|Other|Mechanical debridements|Prior to the beginning of the intervention, all patients received oral hygiene instruction. Mechanical debridements were performed with titanium curette and polishing using a rubber bowl and polishing paste.
15832156|NCT04187222|Biological|Bifidobacterium animalis subsp. lactis|Capsules containing Bifidobacterium animalis subsp. lactis were chubby and subsequently ingested twice a day for 12 weeks.
15832157|NCT04187209|Device|Use of the Atalante exoskeleton|A session includes a stand-up, walks over a distance of 10 meters, exercises with or without the assistance of the exoskeleton, U-turns and a sitting.
15832158|NCT04187196|Drug|Propofol|Propofol will be given at an initial dose of 0.8 mg/kg followed by 20 mg every minute after 2 minutes, if adequate sedation is not achieved
15832159|NCT04187196|Drug|Methohexital|Methohexital will be given at an initial dose of 0.5 mg/kg, followed by 10 mg every minute after 2 minutes, if adequate sedation is not achieved
15832160|NCT04187183|Other|Fresh Platelet Rich Plasma with leukocyte|autologous Platelet Rich Plasma with leukocyte will be infiltrate in the knee joint
15832161|NCT04187183|Other|Fresh Platelet Rich Plasma without leukocyte|autologous Platelet Rich Plasma without leukocyte will be infiltrate in the knee joint
15832162|NCT04187170|Other|Strength physical training|progressive high-load strength training over 6 months, consisting in repeated physical exercises to increase the muscular mass and force by altering concentric and eccentric muscle contractions against high resistance.
15832163|NCT04187157|Device|Blue-light filtering intraocular lens|Bilateral implantation of blue light-blocking intraocular lens
15832164|NCT04187157|Device|Conventional intraocular lens|Bilateral implantation of conventional intraocular lens
15832165|NCT04187144|Drug|Gepotidacin|Gepotidacin will be available as tablets at a unit dose strength of 750mg. Participants will administer two 750 mg tablets, BID. Each dose will be taken with water after consumption of food.
15832166|NCT04187144|Drug|Placebo matching nitrofurantoin|Placebo matching nitrofurantoin will be available as over-encapsulated unit-dose capsules. Participants will administer 1 capsule BID. Each dose should be taken with water after consumption of food.
15832167|NCT04187144|Drug|Nitrofurantoin|Nitrofurantoin will be available as over-encapsulated 100 mg capsules containing 25 mg nitrofurantoin macrocrystals and 75 mg nitrofurantoin. Participants will administer one 100 mg capsule, BID. Each dose should be taken with water after consumption of food.
15832168|NCT04187144|Drug|Placebo matching gepotidacin|Placebo matching gepotidacin will be available as unit-dose gepotidacin placebo-to-match tablet. Participants will administer two tablets, BID. Each dose should be taken with water after consumption of food.
15832169|NCT04187131|Behavioral|augmented reality|The participants will be wearing an EEG cap and Augmented Reality headset (AR-based EEG-guided system) for 10 sessions with a licensed occupational therapist, provided in addition to usual rehabilitation care (either in inpatient rehabilitation or at home). These sessions will focus on activities of daily living that the participants want to practice. All sessions will last approximately 1 hour. These sessions will be scheduled around the existing therapy schedule to cause the least amount of interference with planned clinical activities.
15832170|NCT04187118|Other|Quality of life|Quality of life one year post chemo-therapy
15832171|NCT04187105|Device|Arm1|Experimental: Total marrow irradiation 1.5 Gray (Gy) twice a daily on days -3 and -2
15832172|NCT04187105|Drug|Arm1|"All patients will receive the following standard conditioning regimen:
~Fludarabine 30 mg/m2 IVPB daily from Day -6 (6 days before stem cell infusion) through Day -2"
15832173|NCT04187105|Drug|Arm1|IV cyclophosphamide 14.5 mg/kg intravenously prior to transplant on Days -6 and -5.
15832174|NCT04187105|Device|Arm 1|Total body irradiation 2Gy on day -1.
15832175|NCT04187105|Other|Arm1|Stem cell infusion on day 0.
15832176|NCT04187105|Drug|Arm1|Tacrolimus IV initially in doses of 0.15 mg/kg/day for 3 days, followed by conversion to oral therapy (0.15 mg/kg twice daily)
15832177|NCT04187105|Drug|Arm1|Cyclophosphamide on days 3 and 4 after transplant at a dose of 50mg/kg per day
15832270|NCT04186299|Drug|Articaine Hydrochloride + Epinephrine|Each patient will receive a buccal infiltration of 1.7mL of 4% articaine with 1:100,000 epinephrine.
15832425|NCT04185155|Behavioral|Attention placebo|Smartphone activity for same amount of time.
15832178|NCT04187092|Other|KneeBright Group|"The KneeBRIGHT group will use KneeBright device which consists of an EMG biofeedback interface software that guides users through exercise routines. The wireless EMG sensors includes two small electrodes that will be made to stick to the quadriceps muscles both sides. KneeBRIGHT software features a virtual world wherein patients complete challenges controlling the in-game avatar with the EMG units during exercises specific to knee osteoarthritis rehabilitation.
~The KneeBRIGHT software will incorporates a variety of exercises for strengthening the quadriceps and will employ algorithms based on the Daily Adjustable Progressive Resistance Exercise (DAPRE) technique, in which the quantity of repetitions performed in these sets is then used to determine the appropriate increase (or possibly decrease) in target resistance for the next sets/sessions."
15832179|NCT04187092|Other|Standard Rehabilitation group|Participants in this group will undergo standard clinic based knee rehabilitation. Both groups will perform exact same exercises, however, no KneeBRIGHT device will be used in this group.
15832180|NCT04187066|Behavioral|mindset induction|induction of a health mindset to measure changes in cue-dependent and goal-directed behavior
15832181|NCT04187053|Procedure|Conventional mechanical therapy|Both experimental and sham arms will receive the Conventional mechanical therapy
15832182|NCT04187053|Drug|Saline|Sham group will receive saline as a sham for methylene blue
15832183|NCT04187053|Drug|Methylene Blue|Experimental arm will receive methylene blue
15832184|NCT04187053|Device|Light emitting laser|Experimental arm will receive Light emitting laser
15832185|NCT04187053|Device|Non-light emitting laser|Sham group will receive Non-light emitting laser
15832186|NCT04187040|Procedure|Study intervention: 3-step hand hygiene technique|"3-step hand hygiene technique:
~Covering all surfaces of the hands (based on own judgement)
~Rotational rubbing of fingertips in the palm of the alternate hand
~Rotational rubbing of both thumbs"
15832187|NCT04187040|Procedure|Control intervention: 6-step hand hygiene technique|"6-step hand hygiene technique (according to the WHO Guidelines on Hand Hygiene in Health Care, First Global Patient Safety Challenge):
~Rubbing hands palm to palm
~Palm to palm with fingers interlaced
~Right palm over left dorsum with interlaced fingers and vice versa
~Back of fingers to opposing palms with fingers interlocked
~Rotational rubbing of left thumb clasped in right palm and vice versa
~Rotational rubbing backwards and forwards with clasped fingers of right hand in left palm and vice versa"
15832189|NCT04187014|Drug|Aminocaproic Acid 1000Mg Tab|Oral administration of a total 6 g of aminocaproic acid to reduce blood loss
15832190|NCT04187014|Drug|Tranexamic acid tablets|Oral administration of 3.9 g of tranexamic acid to reduce blood loss
15832191|NCT04187001|Other|Content Validity|Use Delphi technique for achieve consensus
15832192|NCT04187001|Other|Cultural adaptation|Adapt the content to the target population
15832193|NCT04186988|Drug|Fluorine F 18 Ara-G|Given IV
15832194|NCT04186975|Device|Non-Invasive fetal ECG|Non-Invasive fetal ECG
15832195|NCT04186975|Device|Fetal heart rate monitor|Fetal heart rate monitor
15832196|NCT04186962|Other|Behavioral: Simple cognitive task|"A memory reactivation cue followed by playing the computer game Tetris"
15832197|NCT04186936|Drug|Combination Caplet with Loperamide HCl and Simethicone|Participants will receive combination caplet with loperamide HCl 2 mg and simethicone 125 mg as Test product A per assigned treatment sequence.
15832198|NCT04186936|Drug|Loperamide HCl|Participants will receive loperamide HCl 2 mg tablet-lyophilizate orally as part of Reference product B per assigned treatment sequence.
15832199|NCT04186936|Drug|Simethicone|Participants will receive Simethicone 40 mg capsule orally as part of Reference product B per assigned treatment sequence.
15832200|NCT04186923|Other|F-SPOKE|This project includes communicative, emotional, and also organizational support with outreach across different sectors and phases (F-SPOKE - family-centered, cross-sector and cross-phase organizational, communicative, and emotional support).
15832201|NCT04186910|Behavioral|Control group|The control group will carry the Fitbit for the entire period of the recovery but will receive no feedback and will not have the app downloaded onto the telephone.
15832202|NCT04186910|Behavioral|Feedback group|The feedback group will carry the Fitbit for the entire period of the recovery and will receive daily feedback on amount of physical activity carried out and percentage completed of target behavior at the end of the day from an app downloaded on their telephone. The feedback group will also participate in weekly one hour meetings focused on enhancing behavioral strategies to increase self-efficacy and motivation. They will also have their fitbit data analyzed and an agreed upon target of daily activity level increase.
15832203|NCT04186897|Procedure|Occlusal reduction|Occlusal contacts on the functional and non-functional cusps were reduced.
15832204|NCT04186897|Procedure|Sham occlusal reduction|The occlusal surface left intact. No actual occlusal reduction.
15832205|NCT04186884|Other|Quality-of-Life Assessment|Ancillary studies
15832206|NCT04186884|Other|Questionnaire Administration|Complete questionnaires
15832210|NCT04186845|Drug|rhPSMA-7.3 (18F) Injection|Radioligand for PET CT scanning
15832211|NCT04186832|Device|FitBit|Wear FitBit
15832212|NCT04186832|Device|Pedometer|Wear pedometer
15832213|NCT04186832|Other|Quality-of-Life Assessment|Ancillary studies
15832214|NCT04186832|Other|Questionnaire Administration|Ancillary studies
15832215|NCT04186819|Drug|rhPSMA-7.3 (18F) Injection|Radioligand for PET CT scanning
15832216|NCT04186806|Device|3M Dry Mouth Moisturizing Spray to Biotene Moisturizing Mouth Spray|20 ml bottle
15832217|NCT04186806|Device|Biotene Moisturizing Mouth Spray to 3M Dry Mouth Moisturizing Spray|44.3 ml bottle
15832218|NCT04186793|Behavioral|Guided Grocery Shopping (GGS)|"The GGS group will be scheduled for 4 weekly sessions to co-shop with the study Registered Dietitian (RD) or clinical research coordinator (CRC). The primary shopper for the household will be required to attend all 4 sessions. The study participant will be required to attend at least 1 session and other family/household members will be encouraged to attend. The weekly sessions will take place at the family's primary grocery store. During each session, the RD will facilitate selection of low free sugar foods and guide the primary shopper on menu planning for a low free sugar diet. In the 4th session, the primary shopper will be asked to shop independently while being observed by the RD/CRC. Prior to checking out, the RD/CRC will approve and/or correct their shopping choices.
~During the follow-up period, all participants will receive diet counseling/support calls from the dietitian and/or research team at Months 2, 4, and 6, following intervention completion."
15832219|NCT04186793|Other|Diet Provision Group|"This intervention will be applied to each family and will target foods and beverages that contain free sugars added to food by consumer, cook, or manufacturer, but preserve the family's other food group choices. During the 4 week long intervention, families will be able to choose meals from a list of foods similar to their usual diet. Groceries for each week will be delivered to the family. Each child will be provided with a lunch bag and instructed to bring lunch to school to maintain the study diet.
~Families will have the opportunity to choose from a list of pre-prepared evening meals that are similar to what they consumed before study initiation but without free sugars. The families will be instructed to not eat any food outside of the assigned diet.
~During the follow-up period, all participants will receive diet counseling/support calls from the dietitian and/or research team at Months 2, 4, and 6, following intervention completion."
15832220|NCT04186780|Other|Shiitake cereal bar|patients with borderline cholesterol exposed to bars with Shiitake
15832221|NCT04186767|Dietary Supplement|Very Low Carb Ketogenic Diet|Patients will be submitted to very low-calorie ketogenic dietary intervention (VLCK) according to the recommendations of the Pronokal® Method program including lifestyle and physical activity guidelines. The ketogenic stage (phase 1-3) consists of a VLCD diet (600-800 kcal / d), with low carbohydrate intake and lipids. The amount of high biological value proteins ranges from 0.8 to 1.2 g / kg of body weight / day. This first stage (ketogenic) is maintained until the patient reaches the goal of reducing the target weight by 80% to be reduced, being variable in time, according to the response of each patient. After this period, it evolved to a non-ketogenic stage, initiating the hypocaloric diet (800 to 1500 Kcal), with progressive introduction of other food groups, reducing weight more slowly. The maintenance stage consists of a balanced diet, ranging from 1500 to 2000 Kcal.
15832222|NCT04186754|Procedure|Comprehensive functional care plan|The treatment should be carried out INDIVIDUALIZED, in the hospital room or in a conditioned room, in sessions of approximately 30 minutes and on a daily basis. Carried out by professionals in the disciplines of nursing and occupational therapy.
15832223|NCT04186754|Procedure|Traditional intervention without rehabilitation|Clinical control by nursing professionals and exclusively pharmacological treatment
15832224|NCT04186741|Drug|Hyperbaric oxygen|Patients already on treatment by hyperbaric oxygen therapy for medical conditions requiring treatment by it
15832225|NCT04186728|Dietary Supplement|Magnesium glycinate|Daily magnesium capsule.
15832226|NCT04186728|Other|Placebo|Daily placebo capsule.
15832227|NCT04186715|Device|Near-infrared spectroscopy|The Near-infrared spectroscopy probes will be placed in the frontal region.
15832228|NCT04186702|Procedure|INTRAVITREAL RANIBIZUMAB INJECTION|interventions involving RANIBIZUMAB INJECTION 0.5 mg (0.05 mL of 10 mg/mL solution)
15832229|NCT04186689|Other|Routine Dental Examination|Routine dental examination for the pre-school children Questionnaire for their mothers
15832230|NCT04186676|Other|MINOCA registry|Prevalence, demographics, clinical profile, anginal status, presence of cardiovascular risk factors, management and outcomes
15832231|NCT04186676|Diagnostic Test|CCTA Phenotypes|"Complete normal coronary arteries
~Diffuse non-obstructive coronary artery disease
~Non-obstructive high-risk plaques
~Myocardial bridges"
15832232|NCT04186663|Drug|Silver Diamine Fluoride|38% aqueous silver diamine fluoride [Ag(NH3)]2F, CAS RN 33040-28-7
15832235|NCT04186624|Drug|Subacromial-subdeltoid bursa corticosteroid injection|1 ml (7 mg / ml) betamethasone and 4 ml of 0.5% bupivacaine will be given subacromial bursa-subdeltoid space. Injection will be performed ultrasound-guided while the patient is in sitting position with the lateral approach.
15832236|NCT04186611|Other|early occupational therapy|"The intervention will be the one usually carried out but earlier and on a daily basis. It will consist of the initial assessment and then positioning and/or carrying out activities of daily living.
~The daily duration of the intervention will be about 45 minutes to 1 hour. The overall duration of the intervention will be determined according to the objectives and will be at most equal to the time of stay in the intensive care unit."
15832237|NCT04186598|Device|CPAP mask system|Intervention group will receive 15cm of H2O of positive end expiratory pressure
15832238|NCT04186598|Drug|Nifedipine 30 MG|All participants will receive this intervention
15832239|NCT04186598|Device|CPAP mask system without PEEP|Placebo group will receive high flow oxygen via altered CPAP mask system without providing any positive end expiratory pressure
15832240|NCT04186585|Drug|BP-C2|Oral daily intake
15832241|NCT04186559|Drug|Topical Pentoxifylline Gel (Vehicle +PTX)|Patients will be given 1 tube containing 20 ml of topical PTX gel (containing 1,000mg of PTX) to be applied no fewer than four times per day with complete consumption of the entire tube each day.
15832242|NCT04186559|Drug|Topical Placebo Gel (Vehicle)|Patients will be given 1 tube containing 20 ml of topical placebo gel to be applied no fewer than four times per day with complete consumption of the entire tube each day.
15832243|NCT04186546|Device|Zephyr Valve Procedure|The Pulmonx Zephyr Endobronchial Valve is an implantable bronchial valve intended to decrease volume in targeted regions of the lung. It is indicated for the treatment of patients with severe emphysema. The Zephyr Valves are placed in the diseased region of the lung using bronchoscopy. As the diseased region of the lung shrinks in size, healthier regions may expand and function more efficiently, resulting in improved breathing.
15832310|NCT04185961|Device|EVERA-RAPHA with 100mmHG|Apply EVERA-RAPHA with 100mmHG for 4weeks
15832244|NCT04186533|Behavioral|Default Option|The default option is a behavioral economics construct that refers to the option a consumer selects if no active choice is made (e.g. opt-out 401K plans, which significantly increase enrollment, compared to active sign up). Participants in the default condition were presented with a prefilled online shopping cart containing groceries that met nutritional requirements based on participants' gender and age.
15832245|NCT04186533|Behavioral|Nutrition Education|The nutrition education materials were adapted from materials currently utilized by the Supplemental Nutrition Assistance Education Program
15832246|NCT04186520|Biological|8/12-Day Production of Car-T Cells|A fixed dose of 2.5 x 10^6 CAR-20/19-T cells/kg expanded with IL-7/IL-15. (If goal dose of 2.5 x 10^6 cells/kg is not met at 8 days, production will be extended an additional 4 days.)
15832247|NCT04186520|Biological|12-Day Production of Car-T Cells|A fixed dose of 2.5 x 10^6 CAR-20/19-T cells/kg expanded with IL-7/IL-15.
15832248|NCT04186507|Combination Product|Smartwatch with integrated Li+ sensor (provided by Spectrophon LTD)|"To confirm that Li+ is detectable in sweat using Macroduct Sweat Collection System for sweat collection.
~Current studies demonstrate that Li+ can be detected in saliva and in sweat. To confirm it, patients that are on treatment with Li+ will be recruited for this aim; sweat will be collected and checked for Li+ levels.
~To develop the algorithm for Spectrophon LTD biosensors for Li+ levels measurement in sweat that will allow assessing the level of Li+ in blood.
~To evaluate the accuracy and the efficacy of biosensors developed by Spectrophon LTD for Li+ detection in sweat.
~Following positive results in previous objectives, clinical trial will be conducted to estimate the suitability, efficacy and accuracy of developed biosensors for non-invasive detection of Li+ in sweat."
15832249|NCT04186494|Drug|Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml|GLP-1 analogue treatment in combination with advice on diet and physical exercise
15832250|NCT04186494|Device|Continuous positive airway pressure treatment|Gold standard treatment for obstructive sleep apnea
15832251|NCT04186494|Combination Product|Liraglutide and CPAP|Combination of both treatments
15832252|NCT04186481|Device|MINITAC Ti 2.0 suture anchor|The MINITAC◊ Ti 2.0 Suture Anchor is intended to provide secure reattachment of soft tissue to bone in the foot and ankle as well as elbow, wrist and hand.
15832253|NCT04186468|Other|ICU follow-up clinic|The intervention aims at improving health-related quality of life and will contain three components: information, consultation and networking. More information will be available for the participants from the intensive care stay onwards, e.g. an information brochure, and during the entire follow-up period, e.g. by contacting the outpatient clinic via telephone. Participants will be invited to visit the ICU follow-up clinic at least once during the first six months after discharge from ICU. During the visits, participants will be screened for symptoms of PICS and, if required, referred to specialists for further treatment. The aim of the networking part is to improve the exchange between the health sectors and disciplines, e.g. through a special referral letter from the ICU follow-up clinic, and thus to provide a network of outpatient care providers for the former ICU patients.
15832254|NCT04186455|Device|proseal|laryngeal mask proseal
15832255|NCT04186455|Device|baska-mask|laryngeal mask baska-mask
15832256|NCT04186442|Drug|Botulinum toxin type A injection|Experimental
15832257|NCT04186442|Drug|Botulinum Toxin Type A Injection [Botox]|Active Comparator
15832258|NCT04186416|Other|Mostcare® device|The Moscare® system is connected to the patient monitoring devices. Data are collected just before and 5 minutes after the vascular filling.
15832259|NCT04186416|Other|Transthoracic cardiac ultrasound|Transthoracic cardiac ultrasound before and 3 minutes after the vascular filling.
15832260|NCT04186403|Drug|Brexpiprazole|Tablet
15832261|NCT04186390|Other|Simulation training in small bowel capsule endoscopy|Training in the evaluation of small bowel capsule endoscopies including evaluation, diagnostic and treatment in different cases.
15832262|NCT04186377|Other|Standard-of-care for neuropathic/neuroischemic diabetic foot ulcers|Optimization of glycemic control, off-loading, local debridement as needed, atraumatic surface scrubbing, saline washing and sterile dressing
15832263|NCT04186377|Drug|S26E|Daily application of S26E extract on wound site
15832264|NCT04186364|Behavioral|Assigned Ambassador|If assigned to the intervention group, participants will be assigned a medical student ambassador on arrival to the Emergency Department. A brief discussion may take place to review the child's history and survey results, and a copy of the survey will be placed near the patient's bedside for healthcare personnel to review. The student ambassador will accompany the child and their family through key points of their visit and will be expected to make accommodations for the child as determined by the accommodation survey results. The family will be required to allow the ambassador to stay throughout the ED visit.
15832265|NCT04186351|Behavioral|Encounter notification service|The caring support and services provided by SCHSA will consist of multiple components, including standard call & care center support, medical appointment reminder, assistance to reschedule appointment, follow-up calls with either nurse or health workers to monitor health situation of service recipients, assessing needs of service recipient for elderly home care and/or rehabilitation services, providing elderly home care and/or rehabilitation services based on assessment, assessing needs of service recipient for emotional and community support, providing additional emotional support via either social calls by volunteers or counseling by social workers, and making referrals for community support services.
15832266|NCT04186338|Device|Omnidirectional accelerometer monitor (3x3 cm and 16 g, Actical®, Philips Respironics)|All participants were instructed to wear monitors for five consecutive days except during water-based activities. Data for each participant was collected to ensure included three valid weekdays. Daily activity energy expenditure (kcal/kg/min), and sedentary, light, moderate and vigorous levels (min) were examined using a software program.
15832267|NCT04186325|Procedure|DIAPHRAGMATIC exercising|inspiratory muscle training (IMT) will be initiated starting from the first ICU day. IMT will be conducted for 10 minutes two sessions per day, with an initial load of 30% of the maximum inspiratory pressure (MIP) measured immediately after changing patients to pressure support mode, and increased up to 40% in the second 5 minutes if tolerated by the patient. In addition, these patients received the usual care of MV patients.
15832268|NCT04186312|Behavioral|ACCESS - Accessing Campus Connections & Empowering Student Success|Cognitive-Behavioral Treatment delivered across 2 semesters via group and individual mentoring sessions
15832269|NCT04186299|Drug|Clonidine|Each patient will receive a buccal infiltration of 1.7mL of 1:100,000 clonidine.
15832483|NCT04184622|Drug|Tirzepatide|Administered SC
15832271|NCT04186286|Drug|Ivabradine 4-week course|After a baseline screening assessment following a washout period of 7 days, participants will be randomized to start with a 4-week course of ivabradine.
15832272|NCT04186286|Drug|Propranolol 4-week course|After a baseline screening assessment following a washout period of 7 days, participants will be randomized to start with a 4-week course of propranolol.
15832273|NCT04186286|Drug|Placebo 4-week course|After a baseline screening assessment following a washout period of 7 days, participants will be randomized to start with a 4-week course of placebo
15832274|NCT04186273|Drug|Fibrosis-Inhibiting-Compound-FS2|There are three (3) experimental interventions: vehicle moisture balancing base, FS2-0.25 moisturizer, and 0.5 moisturizing base.
15832275|NCT04186273|Other|Vehicle moisture balancing base|Vehicle base without FS2.
15832276|NCT04186260|Behavioral|NAFLD-specific weight loss intervention|This is a 12-month NAFLD-specific weight loss intervention that is explicitly tailored for Mexican-American men. It will include recommendations for diet, physical activity, and will utilize risk for NAFLD as a mechanism to engage men in lifestyle modification.
15832277|NCT04186260|Other|Wait-list control|Participants in this condition will not receive treatment for 12-months until study comparisons have been made. After 12-months, participants will receive the 12-month NAFLD-specific weight loss intervention.
15832278|NCT04186247|Drug|Azithromycin|Weeks 4-12: 7.5 mg/kg azithromycin once daily (500 mg/day maximum) for five consecutive days/ week for 4 weeks, and 3 times a week for the following 4 weeks
15832279|NCT04186247|Drug|Metronidazole|Weeks 4-12: 20 mg/kg/day of metronidazole (10 mg/kg twice daily to a maximum of 1000 mg/day) for 8 weeks
15832280|NCT04186247|Other|Standard of Care|SOC induction therapy is nutritional therapy (Crohn's disease exclusion diet + partial enteral nutrition) for up to 12 weeks. Induction therapy is as assigned by the treating gastroenterologist prior to study entry.
15832281|NCT04186234|Radiation|Stereotactic body radiation therapy|Stereotactic body radiation therapy of 30 to 50 Grays in 5 fractions before liver transplantation
15832282|NCT04186221|Device|OCS Liver System|OCS Liver System for preserving and assessing donor livers for transplantation
15832283|NCT04186208|Drug|NOVOCART 3D|Autologous Chondrocyte Implantation
15832284|NCT04186182|Behavioral|CICI - Feasibility trial study group|The intervention will include 7 individualized meetings with the family (2 home visits + 5 videoconferences), 2 parent group sessions and 4 meetings with school and local care providers, delivered over a 4-5 month period.
15832285|NCT04186169|Procedure|Catheter ablation|Catheter ablation
15832286|NCT04186156|Drug|KA2507|KA2507, an orally-active new chemical entity, is a potent and selective inhibitor of the HDAC6 enzyme, with potential clinical utility in the treatment of melanoma and other solid tumors. KA2507 has been shown to display potent in vitro activity in a range of cancer cell lines, including melanoma cell lines. KA2507 exerts potent in vivo efficacy in a syngeneic model of B16 melanoma. Here, the combination of the agent's direct tumor growth inhibition and metastasis suppression, coupled with its immunotherapeutic activity - demonstrated by decreased expression of STAT-3 and PD-L1 and increased expression of acetylated tubulin, gp100 and MHC Class I in tumors - have been observed.
15832287|NCT04186143|Other|Closed Cinetic Chain Exercises|Sit to stand, mini squat, anterior lunge, step up exercises are performed as Closed Cinetic Chain Exercises.
15832288|NCT04186143|Other|Open Kinetic Chain Exercises|Isometric quadriceps, isotonic quadriceps, hip extension and hip adduction exercises are performed as Open Kinetic Chain Exercises.
15832289|NCT04186143|Other|Control Group|Control Group was followed up by conservative treatment and home program for 12 weeks and they were asked to apply the home program three days in a week. Exercise brochure was handed out for home program. Quadriceps strength and harmstring stretch exercises were applied.
15832290|NCT04186117|Other|Blood sample|Blood sample before any treatment
15832291|NCT04186104|Other|Routine diagnostic process|Patients follow the procedures of registration, waiting, attendance, waiting, examination, waiting, attendance.
15832292|NCT04186104|Other|Artificial intelligence assisted diagnosis process|Patients follow the procedures of registration, AI recommended examination items, Self-service medical history collection ,examination, waiting, AI-assisted attendance.
15832293|NCT04186091|Procedure|correlation between baseline perfusion index and decrease in systolic blood pressure post spinal induction|correlation between baseline perfusion index and decrease in systolic blood pressure post spinal induction
15832294|NCT04186052|Biological|BCMA-CART cells|Target BCMA chimeric antigen receptor T cell infusion
15832295|NCT04186039|Diagnostic Test|Functional magnetic resonance imaging - Blood Oxygenation Level Dependent|"First Functional magnetic resonance imaging - Blood Oxygenation Level Dependent sequence under ambient air.
~Oxygenation of 5 minutes at a rate of 12 l / min. Second Functional magnetic resonance imaging - Blood Oxygenation Level Dependent sequence."
15832296|NCT04186026|Other|Saline + saline|Double saline infusion followed by an ad libitum meal
15832297|NCT04186026|Other|Neurotensin + saline|Neurotensin + saline infusion followed by an ad libitum meal
15832298|NCT04186026|Other|GLP-1 + saline|GLP-1 + saline infusion followed by an ad libitum meal
15832299|NCT04186026|Other|GLP-1 + Neurotensin|GLP-1 + Neurotensin infusion followed by an ad libitum meal
15832300|NCT04186013|Drug|Atezolizumab Injection [Tecentriq]|intravenous infusion of 1.200 mg of Atezolizumab administered intravenously every 3 weeks for a total of 6 doses
15832301|NCT04186013|Radiation|External Beam Radiation Therapy (EBRT)|60 Gy of radiotherapy in 30 fractions overs 6 weeks at 2 Gy/day
15832302|NCT04186000|Biological|Ad26.ZEBOV vaccine|The booster vaccination with Ad26.ZEBOV (5x10^10 vp, same dosage as during the first dose) will be given at 1 year after the first dose or 2 years post-first dose.
15832303|NCT04185987|Other|Leone slide low friction elastomeric ligature|Leone slide low friction elastomeric ligature application
15832304|NCT04185987|Other|RMO tough - o energy elastomeric ligature|RMO tough - o energy elastomeric ligature application
15832305|NCT04185987|Other|Dentsply sili tie elastomeric ligature|Dentsply sili tie elastomeric ligature application
15832306|NCT04185987|Other|AO twisted ended ligature wire|AO twisted ended ligature wire application
15832307|NCT04185974|Radiation|C12 re-irradiation|51 Gy(RBE) or 54 Gy
15832308|NCT04185974|Radiation|Photon re-irradiation|54 Gy(RBE) or 60 Gy
15832309|NCT04185961|Device|EVERA-RAPHA with 60mmHG|Apply EVERA-RAPHA with 60mmHG for 4weeks
15832311|NCT04185948|Behavioral|Mediterranean diet guidelines plus intermittent fasting|For 4 weeks participants will be encouraged to adopt the Mediterranean dietary guidelines as recommended by the Mediterranean Diet Foundation in Barcelona, Spain. In combination with these guidelines, an intermittent fasting regime involving two days of the week will be implemented. The regime will encourage individuals to consume of 500kcal per day for women and 625kcal per day for men, resulting in 75% daily caloric restriction during each of these two days.
15832312|NCT04185948|Behavioral|UK Eatwell guidelines plus intermittent fasting|For 4 weeks participants will be encouraged to adopt the UK dietary guidelines (Eatwell Guide). In combination with these guidelines, an intermittent fasting regime involving two days of the week will be implemented. The regime will encourage individuals to consume of 500kcal per day for women and 625kcal per day for men, resulting in 75% daily caloric restriction during each of these two days.
15832313|NCT04185935|Other|Biospecimen Collection|Provide a sample of blood, a saliva sample, a sample of eyebrow plucks, a sample of urine, and/or stored tumor or healthy tissue
15832314|NCT04185935|Other|Questionnaire Administration|Ancillary studies
15832315|NCT04185922|Device|Hemopatch|As stated in Hemopatch arm description
15832316|NCT04185909|Device|Renuvion Dermal System|The Renuvion® Dermal System consists of an electrosurgical generator unit, a handpiece with detachable standoffs, and a supply of helium gas. Radio Frequency (RF) energy is delivered to the handpiece by the electrosurgical generator unit and used to energize an electrode. When helium gas is passed over the energized electrode, a helium plasma is generated which allows for conduction of the RF energy from the electrode to the subject in the form of a precise helium plasma beam.
15832333|NCT04185870|Diagnostic Test|3D scan|All participants will receive a 360 degrees 3D scan of their chest/pectus excavatum.
15832334|NCT04185870|Diagnostic Test|Standard photography|All participants will receive a the standard photographs and specialised recordings of the current work-up to document their chest/pectus excavatum.
15832335|NCT04185857|Drug|canrenone 50-100 mg orally once a day|After two biochemical and clinical evaluations under baseline conditions and after pharmacological washout from diuretics, betablockers, ARBs or ACEI (about 4 weeks) and MRAs (abut 6 weeks), PA patients will be treated with canrenone 50-100 mg orally once a day. After 1 or 2 weeks the dose will be doubled if necessary to control BP and serum potassium.
15832336|NCT04185857|Drug|olmesartan 10-20 mg orally once a day|"After one month of treatment with canrenone the patients will undergo a clinical and biochemical evaluation (FW1) in a manner identical to the two basal evaluations. After, they will continue with a combination therapy with canrenone, at the dose reached, plus olmesartan starting with 10 mg a day for oral administration, a dose that could be doubled, if necessary, to achieve normotension.
~At the end of the second month of the double therapy, patients will undergo a biochemical re-evaluation at the Center of Hypertension (FW2) with methods identical to those performed in the two baseline evaluations and after one month of canrenone."
15832337|NCT04185831|Drug|Atezolizumab|PD-L1 inhibitor
15832338|NCT04185831|Drug|Everolimus|MTOR inhibitor
15832339|NCT04185831|Drug|Cobimetinib|MEK inhibitor
15832340|NCT04185818|Other|Reading a book|"Participants requested to specify usual genre of book they read.
~Fiction
~Non-Fiction
~Other
~Don't usually read a book in bed"
15832341|NCT04185805|Drug|DWP14012 tablet A|Period 1: DWP14012 tablet B Period 2: DWP14012 tablet A
15832342|NCT04185805|Drug|DWP14012 tablet B|Period 1: DWP14012 tablet A Period 2: DWP14012 tablet B
15832343|NCT04185792|Diagnostic Test|NBSS, Qualiveen and SF-Qualiveen|NBSS, Qualiveen and SF-Qualiveen are self-reported questionnaires.
15832344|NCT04185779|Diagnostic Test|Colonoscopy|Diagnostic colonoscopy
15832345|NCT04185766|Dietary Supplement|Administration of a placebo solution (0.5 ml / kg)|43 newborns at risk of hypoglycaemia to which a placebo solution will be administered (0.5 ml / kg)
15832346|NCT04185766|Dietary Supplement|Administration of a placebo solution (1 ml / kg)|43 newborns at risk of hypoglycaemia to which a placebo solution will be administered (1 ml / kg)
15832347|NCT04185766|Dietary Supplement|Administration of 40% glucose in gel (0.5 ml / Kg)|43 newborns at risk of hypoglycaemia to which a solution of dextrose 40% in gel will be administered (0.5 ml / Kg)
15832348|NCT04185766|Dietary Supplement|Administration of 40% glucose in gel 1 ml / Kg)|43 newborns at risk of hypoglycaemia to which a solution of dextrose 40% in gel will be administered (1 ml / Kg).
15832349|NCT04185753|Diagnostic Test|The prevalence of chronotropic incompetence during maximal cardiopulmonary exercise testing|The prevalence of chronotropic incompetence during maximal cardiopulmonary exercise testing
15832484|NCT04184622|Drug|Placebo|Administered SC
15832350|NCT04185740|Device|CloudUPDRS - Tapping Task|The TTT, consisting of two targets, will be presented on the screen of the smartphone. Participants will be instructed to alternate between the two targets using their index finger for 30 seconds. The task will always be performed with the left hand first and then with the right hand. The touch-sensitive screen of the smartphone will measure the timing of each touch event, its duration, the coordinates on the phone screen and the amount of pressure applied.
15832351|NCT04185727|Other|Supervised strength training|12 weeks supervised strength training exposure. The study will allocate patients to groups consisting of 4 members who receive strength training for 12 weeks. The strength training program will consist of three weekly supervised strength exercise sessions, each 40-60 min of duration, which starts with a 10 min warm-up and are completed with a meditation/relax session.
15832352|NCT04185714|Other|Kinesiotaping|Kinesiotaping (KT) is an approach that supports injured muscles and joints and helps relieve pain.
15832353|NCT04185714|Other|Placebo taping|sham taping
15832354|NCT04185701|Other|SiVIEW software|Eye examination by a technician with the SiVIEW software
15832355|NCT04185701|Other|Expert|Eye examination by an expert including optimal correction in distance and near vision
15832356|NCT04185688|Other|Functional Reach Test|The Functional Reach Test assesses balance by measuring the limits of stability while the patient reaches forwards as far as possible, having the arms in 90° flexion and without lifting the heels off the floor.
15832357|NCT04185675|Device|The laryngoscope used for tracheal intubation under general anesthesia for patients with expected non-difficult airway conditions.|All the patients will receive the same anesthesia induction, and are randomized to three groups to receive different types of laryngoscope for intubation. These are the direct Macintosh laryngoscope, adjustable videolaryngoscope and nonadjustable videolaryngoscope.
15832358|NCT04185662|Dietary Supplement|sucralose|daily intake different dose of artificial sweeteners sucralose or placebo
15832359|NCT04185649|Biological|BAT8001 for injection|3.6 mg/kg, q3w, administered intravenously on day 1 of each treatment cycle, 21 days/treatment cycle.
15832360|NCT04185649|Drug|Lapatinib|Lapatinib 1250 mg was administered orally once per day of each 21-day cycle.
15832361|NCT04185649|Drug|Capecitabine|Capecitabine 1000 milligrams per square meter (mg/m^2) was administered orally twice daily on Days 1-14 of each 21-day cycle.
15832362|NCT04185636|Device|MolecuLight i:X imaging|The MolecuLight i:X Imaging Device will be used to take standard (ST) and fluorescent (FL) images of each graft site. The MolecuLight i:X will also be used to take measurements of the wound using the measurement feature of the device.
15832363|NCT04185623|Procedure|denudation time lag|The time between ovum pickup and denudation of oocyte
15832364|NCT04185610|Other|Qi Gong|Guided Qi Gong class
15832365|NCT04185597|Other|HFP Intervention: Delivered by Community Farmers|Homestead food production (HFP) supported by community farmers, Social and Behavior Change Communication (SBCC), strengthened health services, and referrals to health and other services
15832366|NCT04185597|Other|HFP Intervention: Delivered by agricultural Retailers|HFP supported by retailers, SBCC, strengthened health services, and referrals to health and other services
15832367|NCT04185597|Other|Control|Current Standard of Practice
15832368|NCT04185584|Other|Not Applicable (Observational Study)|Not Applicable (Observational Study)
15832369|NCT04185571|Device|PEPA|
15832370|NCT04185558|Device|ActiGraft|Whole Blood Clot (WBC) gel
15832371|NCT04185558|Device|Standard of Care|Alginate dressing, a non-adherent foam dressing, and an outer gauze wrap
15832372|NCT04185545|Biological|Rotavirus RV3 Vaccine (Bio Farma)|Each 1 mL dose of the final product of oral liquid rotavirus vaccine contains > 5x10^6 fcfu/mL rotavirus vaccine strain RV3
15832373|NCT04185545|Other|Placebo|Each 1 mL dose of placebo contains 30% of sucrose in DMEM
15832374|NCT04185532|Other|Rebound ACL brace and physioterapy|Usage of rebound ACL brace and physioterapy supervised by physioterapist
15832375|NCT04185532|Other|Physioterapy|Physioterapy supervised by physioterapist
15832376|NCT04185519|Device|AI (model)|The process of the experiment (brief describe) This is a randomized, double-blind controlled trial to compare AI (model) with the physician on prescribing ESA dose to maintain hemoglobin near the therapeutic target, 11g/dl. A blind check by another physician for the prescriptions from both physician and AI (model) is arranged for safety purpose. Another physician will fail the prescription if the prescribed ESA dose, by his/her experience, will lead the participant's hemoglobin outside the range between 9 and 13 g/dl. Once the failed rate by AI is higher than the physician is 5%, , the study will be terminated. There will be three periods, namely ry 3 months.
15832377|NCT04185506|Behavioral|DBT+BWL|DBT skills include a focus on emotion regulation, distress tolerance, and mindfulness techniques. BWL includes a focus on monitoring of food intake, calorie reduction, and dietary and physical activity education.
15832378|NCT04185493|Diagnostic Test|CCTA|128-multislice CT coronary angiography and complex atherosclerotic plaque analysis with the use of CT imaging post-processing techniques.
15832379|NCT04185480|Device|Hemopatch|Before closure of the wound this hemostatic sealant (Hemopatch), a pad of collagen derived from bovine dermis will be applied in the axilla
15832380|NCT04185467|Other|Intervention (rehabilitation exercise)|Patients in intervention group (exercise rehabilitation) will receive a multimodal program which includes a 90 minute program at the hospital gymnasium in a supervised environment a minimum of once but up to twice per week. Rehabilitation will include aerobic (brisk walking), resistance training and 30 minutes of 8 style Tai Chi. Participants will be advised to walk on days of non-attendance - this will be individualised with the aim to have participants increase to 30 minutes walking per day.
15832381|NCT04185454|Dietary Supplement|Jarlsberg cheese|Daily intake of Jarlsberg cheese
15832382|NCT04185441|Drug|Tanzânia association|Tanzânia association capsule
15832383|NCT04185441|Drug|Omnic Ocas|Tamsulosin 0,4 mg
15832384|NCT04185441|Other|Omnic Ocas placebo|Tamsulosin placebo
15832385|NCT04185441|Other|Tanzânia association placebo|EMS association placebo
15832386|NCT04185428|Behavioral|Integrative Therapy|still meditation, meditative movement, relaxation techniques, and massage therapy
15832387|NCT04185415|Drug|bepranemab|"bepranemab will be administered in a predefined dosage.
~Pharmaceutical Form: Solution for infusion
~Route of Administration: Intravenous"
15833808|NCT04174066|Other|tissue sample|tissue sample during planned in the follow-up of patients.
15832389|NCT04185402|Drug|Azithromycin|In study communities randomized to the Azithromycin Continuation arm, all individuals aged 1 month and older will receive a single mass distribution of azithromycin several weeks after the baseline and 36-month monitoring visits. In study communities randomized to Azithromycin Discontinuation, participants will receive no treatment.
15832390|NCT04185389|Other|HPV and cytology co-testing (via Liquid based collection device)|Liquid-based cytology co-testing is a procedure in which that a cervical sample is taken, and can be co-tested for HPV and standard cytology at the same time. It is collected in the same way that a traditional Pap is collected
15832391|NCT04185376|Other|Questionnaire|a self-administered questionnaire for the assessment of pelvic floor disorders, their risk factors and their impact of quality of life during pregnancy and postpartum period which integrates bladder, bowel and sexual function, pelvic organ prolapse, severity, bothersomeness and conditions specific quality of life in women with urinary incontinence (UI) and/or POP. The questionnaire is divided into four main domains (bladder, bowel, pelvic organ prolapse, sexual function) and each question is scored from zero to three. The additive scores are divided by the maximum reachable score and multiplied by ten, giving a value between zero (0 = no symptoms) and ten (10 = maximum symptoms) for each of the domains.
15832392|NCT04185363|Drug|Maralixibat|All subjects will receive Maralixibat oral solution (up to 600 microgram per kilogram [mcg/kg]) twice daily for up to 104 weeks
15832393|NCT04185350|Drug|68Ga-NOTA-MAL-Cys39-exendin-4|After 68Ga-NOTA-MAL-Cys39-exendin-4 injection, the patient drank 300-500ml of water and urinated before the PET/CT scans.
15832394|NCT04185337|Procedure|Fine-Needle Aspiration|Undergo ultrasound-guided FNA
15832395|NCT04185337|Procedure|Lymph Node Biopsy|Undergo ultrasound-guided lymph node biopsy
15832396|NCT04185337|Procedure|Photoacoustic Imaging|Undergo ultrasound-guided PAI
15832397|NCT04185337|Procedure|Ultrasound|Undergo ultrasound
15832398|NCT04185324|Behavioral|Standard zippering vest|Standard zippering vest used to teach zippering
15832399|NCT04185324|Behavioral|Modified zippering vest|Modified zippering vest used to teach zippering, along with related story
15832400|NCT04185311|Biological|Ipilimumab|Given IV
15832401|NCT04185311|Biological|Nivolumab|Given IV
15832402|NCT04185311|Biological|Talimogene Laherparepvec|Given intratumorally
15832403|NCT04185298|Behavioral|mSIM intervention plus activity monitoring|Participants will receive the full mSIM intervention and be monitored (via Fitbit)
15832404|NCT04185298|Behavioral|Activity monitoring|Participants will have activity monitored (via Fitbit)
15832406|NCT04185272|Biological|analysis of BTN and BTNL status|analysis of BTN and BTNL expression in colon cancer and hepatic metastasis
15832407|NCT04185259|Other|Acupuncture|The investigators will apply two Ashi points (the two most severe tender points in the most sensitive area over the anteromedial aspect of the heels), Chengshan (BL57), Taixi (KI3) and Kunlun (BL60) in this trial. With the patient in a prone position, the local skin will be routinely sterilized followed by a 10mm diameter and 5mm thick sterile adhesive pad pasting onto each selected acupoint. Ashi points will be perpendicularly inserted through the pad to the plantar fascia layer with a depth of approximately 15-20mm depending on the location. BL57, KI3 and BL60 will be punched perpendicularly 10-15mm deep into the skin through the pad. All needles except Ashi points will be manually stimulated by small, equal manipulations of lifting, thrusting, twirling and rotating to achieve De qi. Needles will be retained for 30 minutes per treatment. During each treatment, every needle will be manipulated three times every 10 minutes.
15832408|NCT04185259|Other|Sham acupuncture|Sham Ashi (0.5 cun away from Ashi, one 'cun' is equivalent to the greatest width of the individual patients' thumb, ~1.5 cm), sham BL57 (0.5 cun lateral to true BL57 horizontally), sham KI3 (midway between true KI3 and heel tendon) and sham BL60 (midway between true BL60 and heel tendon) will be used. Treatment protocol will be similar to that of the acupuncture group. The Hwato-brand disposable blunt-tipped needles (size 0.30 × 25 mm) will be inserted at sham points through adhesive pads to the skin without skin penetration. The needles will then be lifted, thrusted, twirled, and rotated evenly three times every ten minutes. No specific de qi response will be elicited.
15832409|NCT04185246|Drug|NH002 (Perflutren Lipid Microspheres) Injectable Suspension|NH002 is formulated as a microbubble injectable suspension for intravenous administration. NH002 requires an activation process prior to use.
15832410|NCT04185246|Diagnostic Test|Echocardiogram|Each patient will undergo an unenhanced ultrasound examination and a NH002 contrast-enhanced examination on the same day.
15832411|NCT04185233|Other|Games on an iPad|Many games will be programmed on the iPad and organized by age. The child will choose one game and play it during all the procedure time.
15832412|NCT04185233|Drug|Nitrous Oxide|Nitrous oxide will be provided to the child by a mask 3 minutes before the intervention and during all this one.
15832413|NCT04185220|Drug|rhIL-15|IL-15 will be administered by continuous intravenous infusion in a dose-escalation 3 + 3 system with a starting dose of 2 mcg/kg/day and a second dose level of 4 mcg/kg/day on days 1-5 of each of six cycles.
15832414|NCT04185220|Biological|Mogamulizumab|Mogamulizumab (IV over at least 1 hour) will be administered at a dose of 1 mg/kg on days 1, 8, 15 and 22 of cycle 1 and days 1 and 15 of each subsequent cycle. Treatment will continue for a maximum of 6 cycles.
15832415|NCT04185207|Other|no intervention|There is no intervention.
15832416|NCT04185194|Drug|Lidocaine|transmission of the drug molecules to the underlying muscles
15832417|NCT04185194|Device|pulsed ultrasound|using thermogenic and cavitation effect of ultrasound to reduce tight muscles and relieve pain
15832418|NCT04185194|Other|especially designed physical therapy program|by myofascial trigger point release, stretching and strengthening exercises of upper trapezius muscle and infrared radiation by tungsten lamp for upper trapezius
15832419|NCT04185181|Other|virtual reality|wii video game based exercise
15832420|NCT04185181|Other|proprioceptive neuromuscular facilitation|PNF with breathing
15832421|NCT04185181|Other|complete decogestive therapy|pneumatic compression, manual lymph drainage, skin care and home exercise program
15832422|NCT04185168|Dietary Supplement|soy isoflavone|100 mg soy isoflavone (as 2 tablets)
15832423|NCT04185168|Other|control|2 tablets of placebo
15832424|NCT04185155|Behavioral|Simple cognitive task|"A memory cue followed by playing the computer game Tetris on own smartphone. Options to engage in self-administered booster sessions after day 1."
15832426|NCT04185142|Combination Product|cryoballoon ablation combining with left atrial appendage closure|cryoballoon ablation using either 1st or 2nd generation of cryoballoon and left atrial appendage closure using devices including WATCHMAN, Lefort and Lacbes.
15832427|NCT04185129|Drug|Foster|a randomized study for comparison asthma patients using Foster or Relvar. The primary end point is lung function improvement evaluation
15832428|NCT04185116|Device|3D Optic System (Olympus VISERA Elite II 3D)|"Use of the 3D Optic System Olympus VISERA Elite II 3D"
15832429|NCT04185103|Drug|Sacubitril-Valsartan|After signing the Informed Consent, in the shortest possible time, the study investigator will carry out an ergometric test for the T-wave alternans (TWA) while still taking the basal medication. The patient will also sign the prototype Informed Consent for carrying out a stress test on a treadmill. It will also be carried out a basal life quality questionnaire, an analytical determination and a colour doppler echocardiography.
15832430|NCT04185090|Combination Product|ID1803|Amlodipine 10mg/Valsartan 160mg
15832431|NCT04185090|Combination Product|ID1801|Ezetimibe 10mg/Rosuvastatin Ca 20.8mg
15832432|NCT04185090|Combination Product|ID1803+ID1801|Amlodipine 10mg/Valsartan 160mg Ezetimibe 10mg/Rosuvastatin Ca 20.8mg
15832433|NCT04185077|Drug|Bivalirudin|Bivalirudin (Salubris Pharmaceuticals Co) was given as a bolus of 0.75mg/kg followed by infusion of 1.75mg/kg/h during the PCI procedure and for at least 30 minutes but no more than 4 hours afterwards. Following this mandatory infusion, a reduced-dose infusion (0.2mg/kg/h) for up to 20 hours could be administered at physician discretion. An additional bivalirudin bolus of0.3mg/kgwasgivenif the activatedclotting time 5minutes after the initial bolus (measuredwith the Hemotec assay) was less than 225 seconds.
15832434|NCT04185077|Drug|Heparin|a bolus dose of 100 U/kg was administered according to current guidelines.Additional heparinwasadministered if the post-bolus activated clotting time was less than 225 seconds.
15832435|NCT04185064|Device|Game Ready ATX shoulder wrap; Game Ready GRPro 2.1|the Game Ready ATX shoulder wrap that is anatomically engineered for the shoulder joint. The wrap is connected to the Game Ready GRPro 2.1 system enabling the integrated delivery of continuous cold and intermittent pneumatic compression therapy to the shoulder joint and surrounding soft tissues.
15832436|NCT04185064|Other|Standard Care|Participants will undergo post-surgical cryotherapy using the treating surgeons preferred method of cryotherapy, which can include rest, ice, and compression using standard ice packs or bag of ice, a cryocuff, or other such device.
15832437|NCT04185051|Drug|JNJ-67953964|Participants will receive JNJ-67953964 as oral capsules.
15832438|NCT04185051|Drug|Placebo|Participants will receive matching placebo oral capsules.
15832439|NCT04185038|Biological|SCRI-CARB7H3(s); B7H3-specific chimeric antigen receptor (CAR) T cel|Autologous CD4+ and CD8+ T cells lentivirally transduced to express a B7H3 specific chimeric antigen receptor (CAR) and EGFRt given via indwelling central nervous system (CNS) catheter
15832440|NCT04185025|Drug|Ceramides|"On the 0th day, it is determined that one of the leg extensions of the participant is the test side using CeraVe Moisturising Lotion and the opposite side is the control side using Half Mu ceramide body milk by the random table. Participants are required to use the product in the morning and evening according to the Product Use Procedures, during which other moisturizing products or emollients are prohibited. And the follow-up tests are conducted at the prescribed time. At each visit, empty packaging of products used during this period must be collected; if they are not used up as required, the remaining products must be collected."
15832441|NCT04185012|Biological|Benralizumab|Benralizumab 30 mg administered subcutaneously Q4W for the first 3 doses and then Q8W, for a 16 weeks treatment-period
15832442|NCT04185012|Biological|Placebo|Placebo administered subcutaneously Q4W for the first 3 doses and then Q8W, for a 16 weeks treatment-period
15832443|NCT04184999|Drug|dexamethasone intraocular suspension, 9%|single dose intracameral corticosteroid
15832444|NCT04184999|Drug|Prednisolone Acetate 1% Oph Susp|topical ophthalmic steroid drop
15832445|NCT04184986|Diagnostic Test|dry blood test|screening test for Fabry disease
15832446|NCT04184973|Device|CG-100 intraluminal bypass device|a removable, temporary intraluminal bypass device, developed by Colospan, is designed to safely postpone the creation of a protective stoma until 10 days after surgery only for patients who need it (i.e. have a defect in the anastomosis)
15832447|NCT04184973|Procedure|Stoma|Primary protective ileostomy
15832448|NCT04184960|Diagnostic Test|Gastroscopy and gastric biopsies|Gastroscopy would be performed to assess the degree of atrophic gastritis and intestinal metaplasia. In addition, four random biopsies would be taken in the stomach for histological assessment of AG and IM
15832449|NCT04184947|Drug|SGLT2 inhibitor|New prescription of a SGLT-2 inhibitor (dapagliflozin, empagliflozin or canagliflozin) at any dosage during routine clinical practice
15832450|NCT04184947|Drug|GLP-1 receptor agonist|New prescription of a GLP-1 receptor agonisty (exenatide, liraglutide, lixisenatide, dulaglutide) at any dosage during routine clinical practice
15832451|NCT04184921|Drug|Aspirin 100mg|Aspirin, also known as acetylsalicylic acid (ASA), is a very safe medication used to treat pain, fever, or inflammation.
15832452|NCT04184921|Drug|Osimertinib 80 MG|Osimertinib, also known as azd9291, is a 3rd-generation EGFR-TKI used to treat NSCLC patients with resistance to 1st generation EGFR-TKI due to T790M mutation. It has been approved in clinical applications by the FDA in 2015.
15832453|NCT04184908|Drug|gel xerostomia|Apply 2-3 cm of the gel on the tongue, gums and oral mucosa, at least three times a day, if necessary it can be applied at night
15832454|NCT04184908|Other|gel placebo|Apply 2-3 cm of the gel on the tongue, gums and oral mucosa, at least three times a day, if necessary it can be applied at night
15832485|NCT04184609|Other|Control|In this condition, the participants will not receive any medications or drugs before exercise
15832486|NCT04184609|Drug|Albuterol|180 mcg of Albuterol will be administered before exercise
15832487|NCT04184609|Drug|Ipratropium Bromide|34 mcg of Ipratropium Bromide will be administered before exercise
15832488|NCT04184596|Other|Discrete Choice Experiment|An online-based Discrete-Choice Experiment (DCE) using a survey for stated treatment preferences and socio-demographics. Furthermore, the neuropathic pain component will be assessed in all patients with the Numeric Pain Rating Scale instrument.
15832459|NCT04184869|Drug|Belinostat|"Patients can continue to receive belinostat treatment as described in the original study protocol or can be treated per the Investigator's standard of care.
~Belinostat Dose Cohort A & B: 1000mg/m2 Belinostat Dose Cohort C: 750mg/m2 Frequency: once cycle of 21 days: cycle 1, Day 1 and Cycle1, Day 2 to Day 5
~Dose modifications to belinostat during treatment on this extension protocol will be in accordance with the belinostat package insert.
~All patients who receive at least one dose of belinostat treatment in this extension study will be followed for safety through 35 (+/-5) days after their last dose of the treatment or until all treatment related AEs have resolved or returned to Baseline/Grade I, whichever is longer, or until it is determined by the treating physician that the outcome will not change with further follow-up."
15832460|NCT04184869|Drug|Atazanavir|"Patients can continue to receive belinostat treatment as described in the original study protocol or can be treated per the Investigator's standard of care.
~Dose: 750mg/ m2 (Belinostat IV), 400mg (Atazanavir) Frequency: two cycles of 21 days (Belinostat administered through Cycle 2, Day 5) Atazanavir 400mg administered Cycle 1 Day 15 to Day 21, and Cycle 2 Day 1 to Day 5
~Dose modifications to belinostat during treatment on this extension protocol will be in accordance with the belinostat package insert.
~All patients who receive at least one dose of belinostat treatment in this extension study will be followed for safety through 35 (+/-5) days after their last dose of the treatment or until all treatment related AEs have resolved or returned to Baseline/Grade I, whichever is longer, or until it is determined by the treating physician that the outcome will not change with further follow-up."
15832461|NCT04184856|Diagnostic Test|fMRI|(Imaging while) performing reward related tasks.
15832462|NCT04184843|Other|iWalk Toolkit|"Intervention period: 5 months
~Intervention:
~A toolkit consisting of 3 components: an educational guide, a smartphone app, and an educational video.
~Access to a clinical expert by email or phone"
15832463|NCT04184830|Device|non-invasive brain stimulation|
15832464|NCT04184817|Other|Collection of clinical data registered in Easily software|Collection of clinical data registered in Easily software
15832465|NCT04184804|Behavioral|Behavioral Intervention|"The intervention package will be consisted of:
~Introduction of organic fruits and vegetables (by replacing the conventional ones) in school lunch menus
~Signs in school areas about organic fruits and vegetables
~Workshops and interactive games for children
~Seminars for parents"
15832466|NCT04184791|Device|Deep Brain Stimulation|Each DBS electrode contact will be reprogrammed in 60hz and High Frequency Stimulation (180hz) in the Levodopa ON (medicated) and OFF (unmedicated) conditions.
15832467|NCT04184778|Device|Smaller tube size|Comparing how tube size affect patient's experience of postoperative sore throat and hoarseness in men and women.
15832468|NCT04184752|Diagnostic Test|Urodynamic study|The urodynamic assessment included uroflowmetry, filling cystometry with 35°C distilled water at a rate of 60 mL/sec, a pressure flow study, and a stress urethral pressure profile with patient in sitting position [14]. A 20-minute pad test for each woman was also performed [15, 16]. Multichannel urodynamic equipment (Life-Tech, Houston, TX, USA) with computer analysis and Urovision (Urolab Janus System V, Houston) was used. All terminology conformed to the standards recommended by the ICS [3]. All procedures were performed by an experienced technician, and the data were interpreted by a single observer to avoid interobserver variability.
15832469|NCT04184739|Other|My Braces App|An App designed to support patients undertaking orthodontic treatment.
15832470|NCT04184726|Behavioral|Mindfulness Based Cognitive Therapy|mindfulness and cognitive behavioural therapy techniques taught in group sessions meeting once weekly for 8 weeks, and home practice between sessions.
15832471|NCT04184713|Dietary Supplement|Experimental Group|Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement (hypercaloric/hyperproteic with fiber and omega-3 enriched, with L-leucine, betaglucans and medium chain triglycerides) for 8 weeks.
15832472|NCT04184713|Dietary Supplement|Control Group|Nutritional intervention and physical activity recommendations. Consumption of 2 tetra paks/day of a specific oral nutritional supplement (hypercaloric/hyperproteic with fiber) for 8 weeks.
15832473|NCT04184700|Dietary Supplement|EHCF+LGG|Extensively hydrolyzed casein formula containing Lactobacillus rhamnosus GG
15832474|NCT04184687|Procedure|Nanofractures|anterior cruciate ligament reconstruction will be performed in combination with the nanofractures for the treatment of cartilaginous lesions
15832475|NCT04184687|Procedure|no treatment cartilaginous lesions|patient undergoing to the anterior cruciate ligament reconstruction without treatment of the cartilaginous lesions
15832476|NCT04184674|Other|Pneumotachograph|"Measurements will be performed during the first three days of Acute Respiratory Distress Syndrome management :
~The first measurement will be performed 5 minutes after the initial ventilator settings.
~Measurements will be repeated systematically at 24 hours, 48 hours and 72 hours of evolution.
~An additional measure will be performed at each positive end-expiratory pressure modification (maximum 5 measures)."
15832477|NCT04184674|Other|Esophageal catheter|"Measurements will be performed during the first three days of Acute Respiratory Distress Syndrome management
~The first measurement will be performed 5 minutes after the initial ventilator settings.
~Measurements will be repeated systematically at 24 hours, 48 hours and 72 hours of evolution.
~An additional measure will be performed at each positive end-expiratory pressure modification (maximum 5 measures)."
15832478|NCT04184674|Other|Transthoracic and / or transesophageal cardiac ultrasound|"The right ventricle systolic function will be assessed thanks to a transthoracic cardiac ultrasound in children, and a transthoracic of a transesophageal cardiac ultrasound in adults :
~Measurements will be performed during the first three days of Acute Respiratory Distress Syndrome management :
~The first measurement will be performed 5 minutes after the initial ventilator settings.
~Measurements will be repeated systematically at 24 hours, 48 hours and 72 hours of evolution.
~An additional measure will be performed at each positive end-expiratory pressure modification (maximum 5 measures)."
15832479|NCT04184674|Other|Electrical impedance tomography (EIT) for pediatric patients|For pediatric patients: measurements will be performed during the first three days of Acute Respiratory Distress Syndrome management.
15832480|NCT04184661|Other|blood sample|25 mL blood sample will be collected on citrate tubes for osteoclastic analysis.
15832481|NCT04184648|Other|no interventions|no intervention
15832490|NCT04184557|Behavioral|Staying Calm in the OR|"Staying Calm in the OR is a mindfulness-based stress-reduction smartphone tailored for people who are waiting for surgery. It consists of a free, accessible, on-demand, short training through a series of guided meditation practices. They are based on widely studied mindfulness-based programs, such as Mindfulness-Based Stress Reduction (MBSR) ir Mindfulness Self Compassion (MSC)."
15832491|NCT04184544|Other|Improving of quality of care at health facility and outreach level|Community Mobilization and engagement; Use of DHIS data for decision making; Capacity building of health care workers and providers and other Community level and facility level interventions to improve MNCH outcomes
15832492|NCT04184531|Other|Medical Data Collect|It is a retrospective clinical study and we will collect only the medical data registered in our hospital software
15832493|NCT04184518|Drug|Cediranib Maleate|Cediranib 20mg, oral, 5 days on and 2 days off until disease progression
15832494|NCT04184518|Drug|Durvalumab|Durvalumab 1500mg, intravenous, every 4 weeks until disease progression
15832495|NCT04184505|Drug|Azacitidine|75mg/mq/day subcutaneously for 7 days every 28 days
15832496|NCT04184505|Drug|Standard Chemotherapy|"cycle (induction): i.v. 3+7 (Citarabine 200 mg/m2 iv continuous infusion (24 h) for 7 days, Daunorubicine 60 mg/mq iv day 1-3)
~cycle (consolidation): i.v. 3+7 (Citarabine 200 mg/m2 iv continuous infusion (24 h) for 7 days, Daunorubicine 45 mg/mq iv day 1-3)"
15832497|NCT04184505|Procedure|Allogeneic stem cell transplantation|Allogeneic stem cell transplantation
15832498|NCT04184492|Drug|GP-40081|biphasic insulin aspart 30 in doses 0.4 IU/kg
15832499|NCT04184492|Drug|NovoMix® 30 Penfill®|biphasic insulin aspart 30 in doses 0.4 IU/kg
15832500|NCT04184479|Behavioral|LEVAmethod by Bertz et al|Ordinary treatment
15832501|NCT04184466|Drug|Insulin Aspart|insulin aspart in doses 0.3 IU/kg
15832502|NCT04184466|Drug|NovoRapid® Penfill®|insulin aspart in doses 0.3 IU/kg
15832503|NCT04184453|Drug|Deferiprone treated|Deferiprone (25 mg/kg/day) was given to the enrolled patients.
15832504|NCT04184440|Dietary Supplement|Cyclocarya paliurus extract|The participants are divided randomly into three groups，one of which are asked to Cyclocarya paliurus extract for three months .
15832505|NCT04184440|Dietary Supplement|Cyclocarya paliurus compounds|The participants are divided randomly into three groups，one of which are asked to take Cyclocarya paliurus compounds for three months .
15832506|NCT04184440|Dietary Supplement|placebo|The participants are divided randomly into three groups，one of which are asked to take placebo for three months .
15832507|NCT04184427|Other|Anterior Power Arm|Crimpable stainless steel hook placed on orthodontic base arch wire.
15832508|NCT04184414|Drug|CD19-CART|1-10x106 / kg CD19 CART cells
15832509|NCT04184401|Drug|Ascites replacement with albumin and hartmann's solution|"Combined strategy for ascites replacement
~30% of ascites: replacement with 5% albumin
~40% of ascites: replacement with Hartmann's solution"
15832510|NCT04184401|Drug|Ascites replacement with hartmann's solution|"Hartmann's solution only strategy for ascites replacement
~- 70% of ascites: replacement with Hartmann's solution"
15832511|NCT04184388|Dietary Supplement|Hydrolysed Red Ginseng Extract|once a day for 1 p.o., after breakfast(10 ml/day, Hydrolysed Red Ginseng extract for 1g/day) for 12 week
15832512|NCT04184388|Dietary Supplement|Placebo|once a day for 1 p.o., after breakfast(10 ml/day, Hydrolysed Red Ginseng extract for 0g/day) for 12 week
15832513|NCT04184375|Behavioral|cognitive stimulation|"Patients participate in one session per week according to the following schedule:
~2 sensory stimulation sessions: identify sensations, emotions, how to manage them.
~2 sessions on association, verbal fluency, and imagination: language as a tool for expression in the face of illness.
~2 voluntary attention sessions: improve daily attention.
~2 sessions of intellectual structuring: stimulating and maintaining memory, carrying out external activities.
~2 sessions of structuring through language: impact on social life.
~2 sessions stimulating the temporal and spatial landmarks: agenda, daily trips."
15832514|NCT04184362|Device|Empower Neuromodulation System Transcutaneous Electrical Nerve Stimulation|Participants will self-administer treatment with the Empower device two times daily for two weeks. Participants will complete surveys over the two-week period to evaluate the effects of the Empower treatment.
15832515|NCT04184349|Drug|LA group|In the LA group, only the local anesthetic infiltration will be performed by injecting the numbing medicine ropivacaine into the surgical site.
15832516|NCT04184349|Drug|B Group|In the B Group,pectoral (PECS) and transversus thoracic plane(TTP) blocks will be performed by injecting the numbing medicine ropivacaine near the nerves.
15832517|NCT04184336|Other|surveillance|
15832518|NCT04184323|Drug|EX-527 (Selisistat)|EX-527 is a specific inhibitor of the histone deacetylase Sirtuin-1 (SirT1). It is being given to reverse the effects of endometriosis, namely progesterone resistance, that is thought to interfere with the establishment of pregnancy in women with endometriosis
15832519|NCT04184323|Drug|Placebo|We will use the same vehicle for producing the active drug such as maltose without any hormones or active components
15832520|NCT04184310|Other|Modified perineal linear stapler resection for external rectal prolapse|After anesthesia and patient position, the prolapse was pulled out Two vertical incision were made in both the inner and outer walls of the prolapse (at 3and 9 o'clock)1-2 cm in size approximately 2 cm above the dentate line. We used a reloadable linear cutter stapler (GIA 100mm Covidien, Mansfield, Mass., USA) passing through the tunnel to cut the anterior aspect of the prolapse . Then, after reload the stapler by the new cartridge, we used it to do the same for posterior wall and the prolapsed rectum was completely transected . We ensure that the stapler did not fire at the dentate line to avoid post-operative pain. Multiple 3-0 PDS intermittent full thickness sutures were done for hemostasis. The prolapsed rectum falls back into place spontaneously.
15832521|NCT04184297|Drug|Tiotropium and Olodaterol (Tio+Olo)|drug
15832522|NCT04184297|Drug|Long-acting beta2-agonist and Inhaled corticosteroids (LABA and ICS)|drug
15832523|NCT04184271|Drug|38% silver diamine fluoride|Topical application of SDF to teeth
15832524|NCT04184258|Biological|Pooled mesenchymal stem cell|Pooled allogenic mesenchymal stem cell derived from olfactory mucosa
15832525|NCT04184258|Other|Standard treatment according to the Clinical protocols|Standard SLE treatment according to the Clinical protocols approved by the Ministry of healthcare of Republic of Belarus
15832526|NCT04184232|Biological|Dendritic cells|Autologous dendritic cells primed with muc-1/wt-1 peptides
15832527|NCT04184232|Other|Standard treatment according to the Clinical protocols|Standard treatment of bladder cancer according to the Clinical protocols
15832528|NCT04184206|Behavioral|attention training intervention 1|14-day smartphone-based audio-guided attention training program with heavy mindfulness component
15832529|NCT04184206|Behavioral|attention training intervention 2|14-day smartphone-based audio-guided attention training program with moderate mindfulness component
15832530|NCT04184206|Behavioral|attention training intervention 3|14-day smartphone-based audio-guided attention training program without mindfulness component
15832531|NCT04184193|Other|Pulmonary Rehabilitation|Patients will perform a comprehensive, inpatient pulmonary rehabilitation program for 4 weeks duration
15832532|NCT04184167|Other|intermittent fasting 4 months before ICSI|women will start intermittent fasting before starting ICSI by 4 months
15832533|NCT04184154|Other|Questionnaires|The self-questionnaire of 104 questions collected personal and socio-demographics data, global and sexual quality of life characteristics (European Organisation for Research and Treatment of Cancer [EORTC] quality of life questionnaires: QLQ-C30 and gynecologic and cervical cancer specific-questionnaire QLQ-CX24), vaginal dilatators and moisturizers use, and barriers and facilitators of their use. Clinical data were extracted from the patients' medical files. Vaginal stenosis was evaluated at 6 weeks after the end of brachytherapy and after 1-year follow-up by in-town gynecologists or in our Institute, and censored in case of complete vaginal obliteration
15832534|NCT04184141|Drug|Hydroxyzine Hydrochloride|Hyroxyzine hydrochloride is given to the patient one hour before surgery.
15832535|NCT04184141|Drug|Alprazolam tablet|Alprozolam is given to the patient one hour before surgery.
15832536|NCT04184141|Drug|Placebo|Placebo candy
15832537|NCT04184128|Diagnostic Test|Urodynamic study|The urodynamic assessment included uroflowmetry, filling cystometry with 35°C distilled water at a rate of 60 mL/sec, a pressure flow study, and a stress urethral pressure profile with patient in sitting position [14]. A 20-minute pad test for each woman was also performed [15, 16]. Multichannel urodynamic equipment (Life-Tech, Houston, TX, USA) with computer analysis and Urovision (Urolab Janus System V, Houston) was used. All terminology conformed to the standards recommended by the ICS [3]. All procedures were performed by an experienced technician, and the data were interpreted by a single observer to avoid interobserver variability.
15832538|NCT04184115|Drug|DPI-386 Nasal Gel|1.5 mg reservoir of scopolamine to be delivered over a 72-hour period
15832539|NCT04184115|Drug|Placebos|Placebo Nasal Gel and placebo patch
15832540|NCT04184102|Behavioral|education|The intervention group received pre-surgery education and training on therapeutic exercises in addition to the routine hospital care. The educational material was developed by the principal investigator (PI) and included a power point and a booklet with instructions on the exercises as well as information about the surgery and what to expect after the surgery. The educational material was based on previous research and adopted to our population after consultation with a panel of experts including two nurses and three physicians. Eligible women were approached while waiting for their appointment with their surgeon. If they showed interest in participating they signed a consent form. The PI explained the study and what is involved in participating including the weekly phone calls for women in the intervention group. Participants were told that they will visited at home by the PI to assess their ROM and to fill out a questionnaire.
15832541|NCT04184089|Device|High flow nasal cannula (15 L/m)|nasal cannula at a flow rate of 15 l/min and FiO2 of 40%
15832542|NCT04184089|Device|High flow nasal cannula (30 L/m)|nasal cannula at a flow rate of 30l/min and FiO2 of 40%
15832543|NCT04184089|Device|High flow nasal cannula (60 L/m)|nasal cannula at flow rate of 60L/min. Oxygen supplementation will be at an FiO2 of 40%.
15832544|NCT04184076|Behavioral|Time-restricted feeding (TRF) with dietary counseling|"Subjects will be instructed to administer time-restricted feeding.
~Subjects have to compete a 3-d food record, including 2 regular day and 1 holiday. At baseline, a dietitian will provide 15 min of instruction to each participant on how to complete the food records. Subjects will be asked to measure the volume of foods consumed with household measures. The timing of food intake will be also recorded. Food records will be collected each week during the experiment and will be reviewed by the dietitian for accuracy and completeness. A database for food content will be used to calculate the total daily intake of energy, fat, protein, carbohydrate, cholesterol, and fiber. All subjects will be asked to maintain their level of physical activity throughout the entire trial.
~Blood withdraw will be performed prior to the first consumption of food and analyze some biochemistry data."
15832545|NCT04184063|Drug|NBMI|NBMI active treatment
15832546|NCT04184063|Other|Placebo|Placebo for comparison
15832547|NCT04184050|Drug|HPN217|HPN217 is a tri-specific recombinant protein construct (Tri-specific T Cell Activating Construct [TriTAC®]) containing 3 humanized antibody derived binding domains
15832548|NCT04184037|Behavioral|Mindfulness meditation delivered via a mobile app|"This is a six-week intervention that requires completing daily meditation sessions at home using a mobile app while wearing a four-channel EEG device (Muse,RRID:SCR_014418) and headphones. Participants are asked to increase their session duration from 5 to 15 minutes over the first 10 sessions, and continue with 15 minutes thereafter. Meditation sessions in both intervention arms consist of listening to a calm soundscape while focusing one's attention on the present moment.
~Prior to starting the intervention, participants are familiarized with the mobile device, EEG headband, and the study app during an onboarding session. In this session, participants listen to four different meditation exercise instructions (e.g., focusing attention on their breath, counting breaths, thinking of meditation akin to training a puppy) that offer them techniques to use during meditation.The transcript of these exercises and a basic guide on how to use the study app and headband are provided."
15832549|NCT04184024|Other|Massage|"Soft tissue massage known as Swedish massage technique was applied to the neck area for 20 minutes. This massage was carried out 3 days a week for 4 weeks (12 sessions) by the supervisor physiotherapist."
15832550|NCT04184024|Other|Kinesio tape|Patients were taped according to the Kenzo Kase's Kinesio Taping Method by an experienced physical therapist. The application was carried out in a relaxed sitting position. Y banding with extensor muscles on the back of the neck with muscle technique, I banding with the upper trapezius with muscle technique and I banding with ligament technique to the middle region of the neck were performed.
15832613|NCT04183543|Device|Pulsed Electromagnetic Fields|The PEMF device produces pulsed magnetic fields at flux densities up to 1.5 mT peak.
15832551|NCT04184024|Other|Neck stabilization exercise|Neck stabilization exercise was performed in stages with gradual progression according to the stages of motor learning and sensory-motor integration, namely, static, dynamic, and functional. The program started with postural training and then the cervical bracing technique with the activation of deep neck flexors for NSE was performed. The patients were asked to maintain a neutral spine during the exercises and throughout the day as much as possible. The difficulty and variety of exercises were increased weekly. It was carried out 3 days a week for 4 weeks (12 sessions) by the supervisor physiotherapist.
15832552|NCT04184011|Device|SRT-100™|SRT delivers a precise, calibrated dose of radiotherapy following surgical excision for large and more difficult-to-treat keloids that cannot otherwise be treated by or have failed more conservative measures.
15832553|NCT04183998|Other|Trans-spinal Electrical Stimulation (tsES)|Stimulation will be achieved with two self-adhesive stimulation electrodes attached to the dorsal aspect of the neck overlying the cervical vertebrae and two self-adhesive rectangular return electrodes placed over the shoulders. Spinal motor evoked potentials (sMEP) induced by trans-spinal electrical stimulation (parameters, 1 Hz with a 0.1-1 ms pulse width and monophasic waveform) to determine recruitment profiles of proximal and distal motor pools with increasing stimulation intensity ranging from 10 to 200 milliampere. Stimulation parameters for the therapeutic stimulation will be ranged from 5-40 Hz and 20-100 milliampere.
15832554|NCT04183985|Device|Total knee arthroplasty prosthesis|In patients undergoing same-day bilateral total knee arthroplasty, after deciding the implant of TKA(anatomically aligned TKA implant or conventaional TKA implant) using random number table, compare the result of clinical outcome about two instruments.
15832555|NCT04183972|Procedure|ultrasound examination|the participants will be placed in the supine position, with head turned slightly away from the operating side and arms beside the body. The operator will identify right and left interscalene brachial plexuses by ultrasound equipment (Sonosite EDGE or GE LOGIQ e). Clear images and videos of brachial plexus will be captured and saved.
15832556|NCT04183959|Device|video stylet|trachea will be intubated using laryngoscopic assisted video stylet device in lateral position
15832557|NCT04183959|Device|fiberoptic|intubation will be done using fiberoptic device by the same anesthesiologist in lateral position
15832558|NCT04183946|Behavioral|Online Cognitive Behavioural Therapy|"The Willkommen Mutterglück program is an 8-session, interactive web-based CBT intervention for prenatal and postpartum depression and anxiety. The sessions are administered online via audio and video images. Each weekly session has a duration of 40-50 minutes during which the participants are asked to actively participate through exercises and quizzes.
~A SCID interview for screening will be conducted by a trained clinical psychologist and an experienced psychiatrist from our outpatient clinic will verify the diagnosis. Screened and consented participants will answer baseline questionnaires, provide sociodemographic information and receive a private login to access the program. After completing the 2nd, 4th and 8th intervention session participants will fill in psychological questionnaires.
~During the intervention, participants will be contacted three times by telephone by coaches (psychotherapists in training) who follow a manualized script."
15832559|NCT04183933|Other|Pilates Exercise|Pilates exercises will be given for 6 weeks, 3 days in a week.
15832560|NCT04183933|Other|Combined Exercise|Combined exercise will be given for 6 weeks, 3 days in a week.
15832561|NCT04183920|Other|Cranberry juice|cranberry juice cocktail provided by Ocean Spray Cranberries, Inc.
15832562|NCT04183920|Other|Placebo juice|apple juice added with flavor and colorants provided by Ocean Spray Cranberries, Inc.
15832563|NCT04183907|Behavioral|Transform|"The Partner, Blue Mesa Health, has developed a lifestyle intervention program for pre-diabetics that aims to prevent or delay the onset of type 2 diabetes through incremental changes to health behaviours. Transform is based on the CDC's National Diabetes Prevention Program (DPP). Blue Mesa Health adapted the National DPP into a digital experience by combining the use of technology- an app, wearable activity trackers (Fitbit) and digital scales- with the professional guidance of remote health coaches.
~It is a 6-month intervention that helps individuals establish healthier lifestyle habits. Each participant strives to achieve 2 primary goals:
~Attaining 5 to 7 percent weight loss from their starting bodyweight Engaging in at least 150 minutes of weekly physical activity"
15832564|NCT04183894|Behavioral|Personalized Intervention|Participants will receive a personalized intervention based on their personalized network.
15832565|NCT04183881|Drug|Brodalumab 210mg SC|210 mg, subcutaneous dosing, every 2 weeks
15832566|NCT04183868|Drug|Empagliflozin 10 MG|10 mg tablet daily
15832567|NCT04183868|Drug|Glimepiride 2 mg|starting dose: 2 mg tablet daily, 1 mg for lunch and 1 mg for dinner, can undergo to up-titration of glimepiride to a maximum of 6 mg daily
15832568|NCT04183855|Dietary Supplement|Generation UCAN supplementation|carbohydrates - protein (Generation UCAN supplement, 250ml, 10% solution)
15832569|NCT04183855|Dietary Supplement|Mirexus PhytoSpherix supplementation|carbohydrates alone (Mirexus PhytoSpherix, 250ml, 10% solution)
15832570|NCT04183855|Behavioral|satiety ratings|questionnaire on satiety ratings will be provided to participants 15, 30, 45 and 60 min after the drink (or no drink)
15832571|NCT04183842|Dietary Supplement|LACIME Anti-hangover|"LACIME Anti-hangover contains the following excipients:
~Purified water,
~Xanthan gum,
~Glycerin,
~Potassium sorbate (as a preservative)
~Citric acid (acidity regulator)
~Aroma (flavouring agent)
~LACIME Anti-hangover contains the following plant extracts and vitamin:
~Curcuma longa rhizome extract (Curcuma),
~Panax quinquefolius extract (Ginseng panax),
~Malpighia punicifolia extract (Acerola),
~Silybum marianum extract (Milk thistle),
~Desmodium adscendens extract (Desmodium),
~Pyridoxine chlorhydrate (Vitamin B6)."
15832572|NCT04183842|Other|Placebo|"Placebo contains the following excipients :
~Purified water,
~Xanthan gum,
~Glycerin,
~Potassium sorbate (as a preservative)
~Citric acid (acidity regulator)
~Aroma (flavouring agent)
~Placebo contains :
~- Carrot juice"
15832573|NCT04183829|Procedure|induced termination of pregnancy|Medically, induced termination of pregnancy (I-TOP) is defined as an intervention to voluntarily terminate a pregnancy (ie, induced abortion) by either surgical or medical means so it does not result in a live birth.
15832574|NCT04183816|Other|Total cold-water immersion|TCWI group completed a session of 15-minutes in cold water with a temperature of 12°C.
15832575|NCT04183816|Other|Ice massage|Ice cubes massage in a clockwise circular motion on the thigh area (quadriceps) for 15 minutes.
15832614|NCT04183543|Device|Sham Therapy|Inactive Pulsed Electromagnetic Field therapy
15832615|NCT04183517|Drug|PXS-5382A|Orally once daily or twice daily
15832576|NCT04183803|Procedure|anatomic anterior cruciate ligament (ACL) reconstruction|The reconstruction will be performed with hamstring tendon graft or patellar tendon graft. The femoral and tibial tunnels placement will be guided by the Rosa robot (Zimmer®).
15832577|NCT04183790|Drug|ELX/TEZ/IVA|Fixed-dose combination (FDC) tablet for oral administration
15832578|NCT04183790|Drug|IVA|Mono tablet for oral administration.
15832579|NCT04183764|Drug|MAX-40279-01|"Part 1: Dose escalation, MAX-40279-01 twice daily with dose modifications based on tolerability criteria.
~Part 2: Dose expansion, Recommended doses from Part 1."
15832580|NCT04183751|Other|scale study|Forms and questionnaires will be used. The data will be collected by the researchers by face to face interview technique.
15832581|NCT04183738|Drug|NRTIs|"In SOC arm, choice of NRTIs determined by clinician, guided by either genotypic resistance testing or use of a protocol-specified algorithm for N(t)RTI selection.
~In D2N arm, NRTIs are predetermined."
15832582|NCT04183738|Drug|Darunavir|800mg tablet by mouth once daily for 96 weeks.
15832583|NCT04183738|Drug|Ritonavir|100mg tablet by mouth once daily for 96 weeks.
15832584|NCT04183738|Drug|Dolutegravir|50mg tablet by mouth once daily for 96 weeks.
15832585|NCT04183725|Drug|Reduning injection|"Reduning injection:
~2≤Age≤5,0.5ml/kg/day,<10ml/day+5％GS/0.9％NS 50～100ml,iv drip 30～40gtt/min qd*5; 6≤Age≤10,10ml/day+5％GS/0.9％NS 100～200ml,iv drip 30～60gtt/min qd*5; 11≤Age≤13,15ml/day+5％GS/0.9％NS 200～250ml,iv drip 30～60gtt/min qd*5; Age=14,20ml/day+5％GS/0.9％NS 250ml,iv drip 30～60gtt/min qd*5.
~Oseltamivir phosphate granules simulants:
~Weight≤15kg,30mg,po,bid*5; 15<Weight≤23kg,45mg,po,bid*5; 23<Weight≤40kg,60mg,po,bid*5; Weight>40kg,75mg,po,bid*5."
15832586|NCT04183725|Drug|Oseltamivir phosphate granules|"Oseltamivir phosphate granules:
~Weight≤15kg,30mg,po,bid*5; 15<Weight≤23kg,45mg,po,bid*5; 23<Weight≤40kg,60mg,po,bid*5; Weight>40kg,75mg,po,bid*5.
~+Reduning injection simulants: 2≤Age≤5,0.5ml/kg/day,<10ml/day+5％GS/0.9％NS 50～100ml,iv drip 30～40gtt/min qd*5; 6≤Age≤10,10ml/day+5％GS/0.9％NS 100～200ml,iv drip 30～60gtt/min qd*5; 11≤Age≤13,15ml/day+5％GS/0.9％NS 200～250ml,iv drip 30～60gtt/min qd*5; Age=14,20ml/day+5％GS/0.9％NS 250ml,iv drip 30～60gtt/min qd*5."
15832587|NCT04183712|Drug|gemcitabine and oxaliplatin.|GEMOX Conventional chemotherapy:gemcitabine and oxaliplatin.
15832588|NCT04183712|Drug|Afatinib|Target therapy Drug: afatinib
15832589|NCT04183699|Diagnostic Test|Prostate biopsy|MRI-targeted + systematic random prostate biopsy
15832590|NCT04183686|Drug|ACT-1014-6470 (SAD)|Single dose of ACT-1014-6470; soft capsules for oral use.
15832591|NCT04183686|Drug|ACT-1014-6470 (MAD)|Multiple doses of ACT-1014-6470; soft capsules for oral use.
15832592|NCT04183686|Drug|Placebo (SAD)|Single dose of matching placebo; soft capsules for oral use.
15832593|NCT04183686|Drug|Placebo (MAD)|Multiple doses of matching placebo; soft capsules for oral use.
15832594|NCT04183686|Drug|14C-ACT-1014-6470 microtracer|Single dose of 14C-ACT-1014-6470 microtracer; soft capsules for oral use.
15832595|NCT04183686|Drug|14C-ACT-1014-6470 microtracer placebo|Single dose of matching placebo; soft capsules for oral use.
15832596|NCT04183673|Procedure|Laser therapy-cryo thermal therapy|5 days per week, 3 weeks, sessions including laser therapy + cryo therapy followed by usual rehabilitation
15832597|NCT04183673|Procedure|Usual care|5 days per week, 3 weeks, sessions of usual rehabilitation
15832598|NCT04183660|Device|MOBYBOX System|extracorporeal cardiopulmonary support
15832599|NCT04183647|Device|whole body vibration / local vibration|Both the whole-body vibration application and the local vibration application will be applied to the patients in our cross-over study. Between the two applications will be given a washout period of one week. Patients will be evaluated both local and whole body vibration applications, 1 minute and 60 minutes after the end of the applications. After the evaluation, the patient will be rested in the sitting position until the evaluation at the 60th minute.
15832600|NCT04183634|Drug|Rotigotine TTS (Test)|Transdermal patch containing Rotigotine 18 mg to deliver 8 mg/24.
15832601|NCT04183634|Drug|Neupro (Reference)|Neupro®: transdermal patch containing Rotigotine 18 mg to deliver 8 mg/24 h.
15832602|NCT04183621|Diagnostic Test|high resolution impedance manometry|Two detailed swallow assessments to be carried out at between 2-4 months and 8-10 months of age
15832603|NCT04183608|Drug|Adalimumab|Patients will all receive Adalimumab 160/80/40mg EOW until V1 (W14) followed by 40mg EOW until V2 (W26)
15832604|NCT04183608|Diagnostic Test|Calprotectin|Fecal calprotectin dosing at home with IBDoc
15832605|NCT04183608|Other|e-Monitoring|"e-Monitoring at Week 6, Week 10, Week 14, Week 18, Week 22, Week 26, Week 34, Week 38, Week 42 and Week 48
~The patient must complete the first 2 questions of the Mayo score:
~Stool frequency
~The frequency of bleeding
~He must also complete the information on his injections"
15832606|NCT04183608|Other|Therapy Education|Patient Education at W0, W2, W14, W26 and W38.
15832607|NCT04183595|Drug|(N1, N3-bis(2- mercaptoethyl)isophthalamide)|400mg / day NBMI treatment for 14 days, administered as four capsules of 100 mg of NBMI every 24 hours, at the start of treatment, the principal investigator or his delegate will verify the intake of the first dose and deliver a blister pack corresponding to the remaining NBMI capsules, at visit day 14 research subjects will be asked to return the packaging with the remaining capsules or not, in order to estimate adherence to treatment.
15832608|NCT04183595|Other|Excipients microcrystalline cellulose, silica and magnesium stearate|4 Capsules will be administered every 24 hours for 14 days.
15832609|NCT04183582|Behavioral|Behavioural Activation|"Behavioural Activation is a treatment for depression, the current programme has been adapted to suit the needs of postnatal women Session 1: Getting Started Session 2: Identifying Triggers, Reactions and Avoidance Patterns (TRAPs) Session 3: Turning TRACs in to Triggers, Reactions and Alternative Coping (TRACs) Session 4: Support and Communication Session 5: Being a Good Enough Mum Session 6: Staying Well"
15832610|NCT04183569|Other|Sequencing RNA.|RNA-seq, central pivot between genomics and proteomics allows to make the connection between the observed mutations and alteration of protein expression with the identification and quantification of RNA. Thus, we can attest to the expression of mutations identified on DNA, protein and understand whether deregulation is linked to dysregulation of transcription or post-translational modification
15832611|NCT04183556|Drug|Naproxen|use of naproxen twice a day orally in mens time
15832612|NCT04183556|Dietary Supplement|Turmeric|Use of turmeric orally (1 gram powder formula) in mens time
15833809|NCT04174066|Other|excreta|urine sample during planned in the follow-up of patients.
15832616|NCT04183504|Behavioral|Brief parenting intervention|Coaching session on positive parenting practices and promoting child development
15832617|NCT04183491|Biological|Interferon beta-1a|Interferon beta-1a 7.5 µg administered IM
15832618|NCT04183491|Biological|Interferon beta-1a|Interferon beta-1a 15 µg administered IM
15832619|NCT04183491|Biological|Interferon beta-1a|Interferon beta-1a 30 µg administered IM
15832620|NCT04183491|Biological|Peginterferon beta-1a|Peginterferon beta-1a 31.25 µg administered SC
15832621|NCT04183491|Biological|Peginterferon beta-1a|Peginterferon beta-1a 62.5 µg administered SC
15832622|NCT04183491|Biological|Peginterferon beta-1a|Peginterferon beta-1a 125 µg administered SC
15832623|NCT04183491|Biological|Placebo|Placebo (administered either IM or SC)
15832624|NCT04183478|Drug|K-001|K-001 is an antitumor active substance (peptidoglycan) which is prepared from the fermentation product of marine microorganism. K-001 is the Chinese first class new drug and get patent licensing in China, America and Japan.
15832625|NCT04183478|Other|placebo|Placebo which looks the same as K-001 in apparence
15832626|NCT04183465|Other|Health Education|Current gold standard in older patients admitted to hospital for MI. The group will receive a 20-minute session with one of the study physicians. Both the patient and relatives will attend these sessions. The study physician will stress the major issues related to a heart-healthy lifestyle and will explain the importance of PA as a powerful and independent factor to improve cardiovascular health and minimize cardiovascular risk. A detailed brochure explaining the benefits of physical activity will be provided to all patients
15832627|NCT04183465|Other|Exercise Intervention|The PA intervention consisted of supervised sessions combined with an individualized home-based PA program. Centre-based sessions will be supervised by a sports physician and a nurse, and will take approximately 30 to 40 minutes, including a moderate standardized treadmill-walk, and strength and balance exercises. Based on the practice sessions, patients will receive a walking program to perform at home, unsupervised. The PA programs will be individualized, and consistent with current international recommendations. A selection of calisthenic exercises will be prescribed. Participants will be encouraged to perform the exercises three times per week (approximately 20 minutes). Adjustment of the type and intensity of the home-based PA regimen will be made at each visit. The PA program will be extensively described to the patient and family members.
15832628|NCT04183452|Drug|17-Hydroxyprogesterone Caproate 250 mg IM Dose|17-Hydroxyprogesterone Caproate is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.
15832629|NCT04183452|Drug|17-Hydroxyprogesterone Caproate 275 mg SC Dose|17-Hydroxyprogesterone Caproate is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth
15832630|NCT04183426|Diagnostic Test|Carotid Artery Reactivity test (CAR test)|The CAR test will be applied to stimulate the sympathetic nervous system. This thermal stimulus is known to elevate blood pressure via sympathetic pathways, so it can be used to study the vascular response to sympathetic activation. The participant will submerge their left hand in a bucket of ice water (approximately 4 degrees celcius) for 3 minutes, which is reported to be sufficient to induce a maximal dilation in the common carotid artery. At baseline and every minute after the hand is submerged in ice water, the blood pressure will be measured to check whether a sympathetic stimulation is achieved.
15832631|NCT04183426|Diagnostic Test|Arterial Stiffness|"The SphygmoCor device will be used to non-invasively measure arterial stiffness parameters using applanation tonometry. For Pulse Wave Analyses (PWA), the radial waveform will be recorded. Approximately 10 waveforms are averaged, resulting in several non-invasive parameters:
~Peripheral pressure parameters
~Central and abdominal aneurysm pressure parameters (derived using a transfer function)
~Cardiac output parameters (sub-endocardial viability ratio (SEVR), Ejection Duration (ED))
~Pulse wave velocity will be performed by recording the waveforms of the carotid and femoral artery sequentially. The travelled distance will be measured according to the current guidelines and entered in the program. The program will calculate the PWV based on 10 ECG triggered waveform of each artery."
15832632|NCT04183413|Other|PEN|This intervention consists of the strengthening of primary healthcare facilities to screen for diabetes and hypertension, and to provide care for uncomplicated cases of these conditions. The intervention will broadly follow the disease screening, management, and referral protocols detailed in the WHO-PEN guidelines and adapted for the Eswatini context during a feasibility pilot.
15832633|NCT04183413|Other|ePEN|"This arm consists of all activities of arm 2 (the PEN arm) plus additional responsibilities for community health workers who are affiliated with the given healthcare facility through the public-sector health system structure. Specifically, community health workers will i) conduct household visits to refer adults aged 40 years and older who have not been screened for diabetes and hypertension in the past 12 months to the primary healthcare facility with which the community health worker is affiliated, ii) provide counseling on reducing one's risk of cardiovascular disease during these home visits, iii) follow up with individuals whom they referred to a healthcare facility at their home, and iv) provide information on primary and secondary prevention of cardiovascular disease at community meetings."
15832634|NCT04183400|Behavioral|Safety Awareness For Empowerment (SAFE)|SAFE is a mindfulness-based cognitive-behavioral intervention that aims to build risk-related attention skills.
15832635|NCT04183387|Drug|Simvastatin 40mg|
15832636|NCT04183374|Other|Life style|Lifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation
15832637|NCT04183361|Diagnostic Test|ABR and salivary cortisone testing|"Three saliva samples at the workplace will be collected immediately after the morning shift. The first saliva sample was given 3 days (Tuesday) before arrival at the research place, the second sample 2 days (Wednesday) before arrival, and the third sample 1 day (Thursday) before arrival at the research site. One hour before saliva sampling, a respondent should not brush his/her teeth nor eat nor drink. Fifteen minutes prior to sample administration, the subject should rinse his/her mouth with a cold water. Samples will be analyzed using High Performance Liquid Chromatography (HPLC) at the Translational Medicine Division of the Srebrnjak Children's Hospital.
~2. Collaboration in the process of assessing hearing health at the research place. The assessment includes: otoscopy, tympanometry and audiometry. Subjects will be tested for auditory evoked brainstem response in only one ear, with a more regular hearing threshold."
15832696|NCT04182932|Biological|CJ-40010 EV71 vaccine A dose|Inactivated vaccine against EV71, three doses, 28 days interval
15832638|NCT04183348|Behavioral|Training Protocol n°1 first at Visit 1, then, Training Protocol n°2 at Visit 2|"During Protocol 1 (visit 1), participants of Group A will perform auditory spatial localization tasks with sensory feedback and during Protocol 2 (visit 2), they will perform auditory tasks without any notion of spatial localization. The 2 visits will be spaced at least 2 weeks (Wash-out).
~The effects of each of the protocols on spatial location hearing abilities will be specifically assessed by comparing the results of the different assessments (SPHERE and Visual Discrimination Test) obtained before and after each protocol."
15832639|NCT04183348|Behavioral|Training Protocol n°2 first at Visit 1, then, Training Protocol n°1 at Visit 2|"During Protocol 2 (visit 1), participants of Group B will perform auditory tasks without any notion of spatial localization and during Protocol 1 (visit 2), they will perform auditory spatial localization tasks with sensory feedback. The 2 visits will be spaced at least 2 weeks (Wash-out).
~The effects of each of the protocols on spatial location hearing abilities will be specifically assessed by comparing the results of the different assessments (SPHERE and Visual Discrimination Test) obtained before and after each protocol."
15832645|NCT04183322|Biological|13-valent pneumococcal conjugate vaccine|
15832646|NCT04183309|Other|Measure the transpulmonary pressure in pediatric patients|Esophageal pressure will be measured by an esophageal ballon to assess transpulmonary pressure during laparoscopy surgery. Lung collapse will detected when transpulmonary pressure became negative and using lung ultrasound images. Lung ultrasound examinations will be performed at different times-points: after anesthesia induction, 10 minutes after pneumoperitoneum insufflation, and at the end of surgery. A lung recruitment maneuver will be applied if these patients present atelectasis during surgery.
15832647|NCT04183296|Drug|propofol|Anesthesia was induced with TCI of propofol (Ce of 4.0-4.5 μg/ml) and remifentanil (Ce of 4.0 ng/ml). Anesthesia was maintained with TCI of propofol and remifentanil. Anesthesia depth was adjusted to maintain a PSI of 25-50.
15832648|NCT04183296|Drug|sevoflurane|Anesthesia was induced with an intravenous bolus of propofol 1.5-2 mg/kg and TCI of remifentanil (effect-site concentration [Ce] of 4.0 ng/ml). Anesthesia was maintained with sevoflurane (0.8-1 age-adjusted minimum alveolar concentration) and TCI of remifentanil
15832649|NCT04183283|Drug|LY3526318|Administered orally.
15832650|NCT04183283|Drug|Placebo|Administered orally.
15832651|NCT04183270|Other|Questionnaires|The survey will focus on non-valvular atrial fibrillation patients, who will start treatment with a NOAC, and their treating physician.
15832652|NCT04183257|Drug|oral vitamin D|oral Vitamin D 400IU will be given and will be escalated every 2 weeks.
15832653|NCT04183244|Procedure|Erector spinae block|A 5-cm needle prick in the back of the patient 3 cm lateral to mid-line under sterile conditions, with ultrasound guidance.
15832654|NCT04183244|Procedure|Infraclavicular subomohyoid (ISO) block|Under complete aseptic precaution, 12 cm needle will be inserted 2cm superior to the clavicle and advanced retroclavicular, with ultrasound guidance.
15832655|NCT04183231|Drug|Anti-caries varnish|topical tooth varnish
15832656|NCT04183218|Procedure|Biospecimen Collection|Undergo biospecimen collection
15832657|NCT04183218|Device|Cardiac Event Monitor|Receive cardiac monitor
15832658|NCT04183218|Other|Chemoradiotherapy|Undergo CRT
15832659|NCT04183218|Radiation|Radiation Therapy|Undergo RT
15832663|NCT04183192|Biological|Mepolizumab|Mepolizumab 3 mg administered SC
15832664|NCT04183192|Biological|Mepolizumab|Mepolizumab 6 mg administered SC
15832665|NCT04183192|Biological|Mepolizumab|Mepolizumab 12 mg administered SC
15832666|NCT04183192|Biological|Mepolizumab|Mepolizumab 24 mg administered SC
15832667|NCT04183192|Biological|Reslizumab|Reslizumab 0.1 mg/kg administered IV
15832668|NCT04183192|Biological|Reslizumab|Reslizumab 0.2 mg/kg administered IV
15832669|NCT04183192|Biological|Reslizumab|Reslizumab 0.4 mg/kg administered IV
15832670|NCT04183192|Biological|Reslizumab|Reslizumab 0.8 mg/kg administered IV
15832671|NCT04183192|Biological|Placebo|Placebo (administered either IV or SC)
15832672|NCT04183179|Behavioral|Happy Family, Healthy Kids Program|"The 14-week healthy eating program activities including four components:
~A 14-week parent Facebook-based program focusing on stress management and healthy eating to reduce emotional eating and increase parents' capacity to initiate healthy eating practices at home
~Three parent face-to-face or virtual meetings at Head Start centers to connect parents with each other in person, offer healthy cooking tools/classes, and discuss behavioral change strategies and challenges
~14-week child Eat My ABCs program at Head Start centers to provide an age-appropriate, healthy eating program to children
~Weekly child letter to parents to connect child learning at the Head Start center with parental practices at home"
15832674|NCT04183153|Device|Repetitive Transcranial Magnetic Stimulation|Participants will receive repetitive transcranial magnetic stimulation (rTMS) to determine if stimulating areas with activating functional connectivity will activate the hypothalamus and in turn, have a measurable effect on hormone levels.
15832675|NCT04183140|Procedure|primary percutaneous coronary intervention|primary percutaneous coronary intervention via transulnar or transradial access
15832697|NCT04182932|Biological|CJ-40010 EV71 vaccine B dose|Inactivated vaccine against EV71, three doses, 28 days interval
15832676|NCT04183127|Other|No intervention|ACPs, qualified or in training, will be invited to participate by email. Interested participants will be provided with study materials and asked to complete an online eligibility questionnaire; if eligible, contact details will also be recorded. Participants will be invited to take part in a focus group about their experience in developing clinical competence and their opinions on role identity. Data collection will consist of focus groups.
15832677|NCT04183114|Biological|Measles-Rubella vaccine Bio Farma|MR vaccine produced by Bio Frama with 3 consecutive batches
15832678|NCT04183114|Biological|MR Vaccine SII|MR Vaccine produced by SII (Already registered in Indonesia)
15832679|NCT04183101|Drug|Aliskiren|Patients will be randomized to start treatment with aliskiren tablet 150 mg every other day up to 300 mg daily depending on weight. After 6 months switch to enalapril 2.5-20 mg daily and continue with that 2.5 years.
15832680|NCT04183101|Drug|Enalapril|Patients will be randomized to start with enalapril 2.5-20 mg daily depending on weight. After 6 months switch to aliskiren tablet 150 mg every other day up to 300 mg daily depending on weight and continue with this treatment for 2.5 years.
15832681|NCT04183088|Drug|Tislelizumab+regorafenib for part 1;Tislelizumab+regorafenib for group 1 of part 2; Regorafenib for group 2 of part 2.|"There will be no dose reduction for tislelizumab in this study. In the part 1(safety cohort), if the subjects do not experience grade 2 or greater regorafenib-related adverse events after 2 cycles (6 weeks) of treatment, the dosage of regorafenib may be escalated. For subjects who escalate the regorafenib dosage to Level 2, if the subjects do not experience grade 2 or greater regorafenib-related adverse events after 2 cycles of study drug treatment, the dosage of regorafenib may be further escalated to Level 3.
~During study drug treatment, dose delay/ interruption of regorafenib will be done depending on the occurrence and severity of regorafenib-related adverse events. After dose reduction of regorafenib, if the subjects tolerate the reduced dose of regorafenib well, the investigators may consider re-escalation of regorafenib to the previous dose level, depending on the types and severity of adverse events that led to dose reduction."
15832682|NCT04183075|Dietary Supplement|FontActiv Superprotein/Hypercaloric Fiber|The product under study has a liquid presentation, in 200 ml bottles, ready to take
15832683|NCT04183075|Dietary Supplement|Carbohydrates and C Vitamin|The control product will be prepared with equal presentation and taste as similar as possible tan study product
15832684|NCT04183062|Drug|Chemotherapy (gemcitabine & docetaxel) plus BIO-11006|"BIO-11006 will be administered at a dose of 75 mg twice daily for patients over 5 years of age and under 18 years of age or 125 mg twice daily for patients 18 years of age or older. The study drug will be administered twice daily by nebulizer over 20 minutes.
~GemTax will be administered in 21-day cycles. Gemcitabine will be administered at a dose of 900 mg/m2 IV over 90 minutes on days 1 and 8. Docetaxel will be administered at a dose of 75 mg/m2 IV over 60 minutes on day 8."
15832685|NCT04183036|Procedure|Endoclip papillaplasty|Endoclip papilloplasty was performed to repair the Oddi sphincter using sterile repositionable hemostasis clipping device (Micro-tech (Nanjing), Co., Ltd.; stainless-steel). The operator positioned the clip and assessed the clip position and made sure the incision was clipped. Four to five endoclips were positioned in the incision in a zipper way from distal to proximal papillary sphincterotomy
15832686|NCT04183023|Genetic|Collection of a salivary sample|"Volunteers who agreed to participate will have to collect their saliva with the self-collection device. They will then send back their saliva sample and a dated and signed copy of the informed consent form in the pre-paid return envelope.
~All DNA of the saliva samples will be automatically extracted, then DNA samples will be genotyped and 4,000 of them will be sequenced.
~The genotyping will consist of measurement of general genetic variation, including the Single Nucleotide Polymorphisms. The SNP genotyping will be carried out using Illumina high density chips, in CNRGH production platform.
~A subset of 4,000 individuals will be selected to provide a homogeneous geographic coverage and to avoid inclusion of related individuals who will share large genomic regions. Sequencing will be performed in order to reach a mean coverage of 30X for each sample and a minimum of 25X mean coverage.
~Finally, a bioinformatics analysis will be performed on sequencing data."
15832687|NCT04183010|Behavioral|Physical activity coaching|"Interventions will be delivered via smartphone and will consist of physical activity coaching. Once randomized to the Coaching arm, individuals will be presented with seven broad categories of physical activity. They will receive a daily notification on their phone indicating that they have study activities to complete. They will then click on this notification and will be offered five options:
~A low intensity activity from one of the categories they selected upon start of coaching
~A moderate-to-vigorous endurance activity
~The participant will be linked to video content with exercise tutorials/video coaching
~Option to skip exercise that day
~Option to fill in a different activity that the participant completed (free text entry)
~The participant will then select one of these options and complete the chosen activity. They will be presented with the question Did you completed the exercise with three options:
~Yes
~No
~Give me a different exercise"
15832688|NCT04182997|Drug|Dexamethasone|Patients included in the treatment group will have their surgical site lavaged with dexamethasone at the end of their surgery.
15832689|NCT04182997|Drug|saline 0.9%|Patients included in the placebo group will have their surgical site lavaged with sterile saline at the end of their surgery.
15832690|NCT04182984|Drug|Symptomatic Treatment, Steroids, Immunosuppressive Agents( azathioprine, tacrolimus, Mycophenolate Mofetil)|Treatment regimens are determined according to the physician's judgment and preferences of the patients.
15832691|NCT04182971|Other|Fruit|Phase 1 is 227g of orange fruit, Phase 2 is 230g of apple fruit
15832692|NCT04182971|Other|Fruit juice|Phase 1 is 250g of orange juice, Phase 2 is 235g of apple juice
15832693|NCT04182971|Other|Fruit juice plus fiber|Phase 1 is 157g of orange juice + 100g of orange pomace fiber (39% pomace by weight), Phase 2 is 129g of apple juice + 106g of apple pomace fiber (45% pomace by weight)
15832694|NCT04182958|Drug|(14C)-OPC-61815|On the morning of Day 1, all subjects will receive a single IV infusion of (14C) OPC-61815
15832695|NCT04182945|Other|Data collection for algorithm development|50% of the research prototypes (4 pieces) will be mounted to the patient on left side of the body (sub clavicula, lateral ribcage, upper arm and wrist), after being admitted to the ICU and having signed the informed consent. As soon as a patient gets fever, the other 50% of the research prototypes (4 pieces) will be applied on the right side of the body (sub clavicula, lateral ribcage, upper arm and wrist). Data will be collected unobtrusively (no diagnosis will be made) and used for fever detection algorithm development.
15833868|NCT04173650|Drug|AGLE 102|Exosomes from MSCs
15832698|NCT04182932|Biological|CJ-40010 CVA16 vaccine C dose|Inactivated vaccine against CVA16, three doses, 28 days interval
15832699|NCT04182932|Biological|CJ-40010 CVA16 vaccine D dose|Inactivated vaccine against CVA16, three doses, 28 days interval
15832700|NCT04182932|Biological|CJ-40010 Bivalent vaccine E dose|Inactivated vaccine against EV71/CVA16, three doses, 28 days interval
15832701|NCT04182932|Biological|CJ-40010 Bivalent vaccine high dose|Inactivated vaccine against EV71/CVA16, three doses, 28 days interval
15832702|NCT04182932|Biological|Placebo|Placebo, three doses, 28 days interval
15832703|NCT04182919|Drug|Phlai|Each capsule contains 4 mg compound D. Using orally in the evening everyday in 4 weeks
15832704|NCT04182919|Drug|Placebo oral capsule|Like Phlai capsule extract : :PVP K30, Calcium carbonate, Dibasic calcium phosphate, Sodium starch glycolate, Colloidal silicon dioxide, Ethanol 96%, Purified water, Magnesium stearate. Not having compound D. Using orally in the evening everyday in 4 weeks
15832705|NCT04182906|Behavioral|Care Coordination|Screening and referral for basic needs and adult mental health
15832706|NCT04182906|Behavioral|Resiliency Clinic|Mindfulness-based caregiver-child group medical care
15832707|NCT04182906|Behavioral|Usual Care|Usual Primary Pediatric Care
15832708|NCT04182893|Diagnostic Test|ctDNA and Exosome Combined Detection|Through the detection and analysis of blood and alveolar lavage fluid of 300 patients with pulmonary nodules and 100 healthy population, the diagnostic efficacy of ctDNA and exosomes combined detceion will be studied.
15832709|NCT04182880|Drug|CPL-01|CPL-01 will be administered
15832710|NCT04182880|Drug|Placebo|Placebo will be administered
15832711|NCT04182867|Other|Dietary intervention|Dietary modification (provision of diet).
15832712|NCT04182854|Drug|Furosemid hydrochlorothiazide|furosemide 100mg for one month;furosemide 200mg for one month;furosemide 100mg and hydrochlorothiazide 25mg for one month;
15832713|NCT04182841|Device|RheOx|RheOX is a CE-marked device-based, energy delivery system that delivers energy to ablate soft tissue such as the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope.
15832714|NCT04182828|Drug|Lidocaine|both the drugs will be prepared in same volume, color, consistency and appearance
15832715|NCT04182815|Device|Robotic assisted bronchoscopy|Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.
15832716|NCT04182789|Drug|KN035|KN035150mg，once a week, subcutaneously. Every 28 days is a treatment cycle.KN035 can be used for up to 2 years.
15832717|NCT04182763|Other|CoA-Z|People with PKAN lack a chemical to process or metabolize a certain vitamin in the brain. CoA-Z is designed to bypass this metabolic defect that causes PKAN.
15832718|NCT04182763|Other|Placebo|The placebo is a strawberry-flavored syrup that looks and tastes like CoA-Z but has no active CoA-Z in it.
15832719|NCT04182750|Other|Pharmacist consultation|"The intervention is a patient-centered consultation that will last about 15 minutes. The intervention is defined as A planned, individualized, and structured conversation with the purpose to relieve pregnant women for any concern and answer questions she may have regarding self-care ailments and medication use in pregnancy. Specifically, the consultation will:
~Answer any questions the participants may have within pharmaceutical care.
~Improve pregnant women's understanding of common pregnancy-related ailments and hence contribute to better management of the ailments.
~Raise awareness, provide confidence, and give information about safe medications options in pregnancy
~Focus on preventative measures for NVP.
~Contribute to better adherence for needed/chronic medication throughout the pregnancy.
~The pharmacists will beforehand have access to the women´s answers from the baseline questionnaire Q1, including information about her medical conditions and medication use."
15832720|NCT04182737|Drug|IgM-enriched polyclonal immunoglobulins titer-based treatment|Immunoglobulins will be administered in a personalized dose based on serum IgM-titers
15832721|NCT04182737|Drug|IgM-enriched polyclonal immunoglobulins Flat treatment|Polyclonal endovenous immunoglobulins enriched in IgM administered in standard fixed dosages
15832722|NCT04182724|Drug|Camrelizumab, Apatinib and Nab-paclitaxel|Camrelizumab was administered 200mg iv every 2 weeks, Apatinib was administered 250 mg p.o. qd Nab-paclitaxel was administered 125 mg/m2, 150 mg/m2, 175 mg/m2 or 200 mg/m2, iv. q2w
15832723|NCT04182711|Device|Device|Phase 1: Time taken for each patient is 25 mins Phase 2: Time taken for each patient is 30 mins
15832724|NCT04182698|Drug|Simultaneous chemoradiotherapy for An Luo|"Experimental group: anlotinib(d1-14, d22-36), followed by 21 days period, 2 weeks medication, 1 week maintenance therapy.
~. Group II: 10 mg po qd, Group III: 12 mg po qd;
~Combined chemotherapy:
~Cisplatin + etoposide Or PC: carboplatin AUC2, paclitaxel 45-50 mg 2 per week; Cisplatin + cultured beauty (non squamous cell carcinoma). Synchrotron radiation: radiotherapy combined with radiotherapy (3D-CRT or IMRT) (60-66Gy / day).
~The curative effect was evaluated after 6 weeks of simultaneous radiotherapy and chemotherapy combined with alotinib, and then the efficacy of alotinib or chemotherapy was maintained until PD."
15832726|NCT04182659|Device|Transcranial Magnetic Stimulation|A non-invasive treatment that emits magnetic pulses to stimulate the brain.
15832727|NCT04182659|Device|Sham Transcranial Magnetic Stimulation|Sham rTMS will consist of the same parameters as active, however, the subject will not receive the actual magnetic stimulation due to the use of a double sided Active/Sham coil used specifically for research studies.
15832728|NCT04182646|Device|Spartz Balloon|The Spatz Adjustable intragastric balloon (AIGB) was developed to extend implantation to 1 year, decrease balloon volume for intolerance and increase volume for diminishing weight loss effect. The concept of an adjustable balloon came from the fact that around 10% of patients are intolerant to the balloon, requiring early extraction and also gastric balloons lose their effectiveness by approximately the 4th month post-implantation, and studies have shown that patients actually regain weight while the balloon is still implanted. AIGB balloon can mitigate this effect by adjustment of balloon volumes as required
15832729|NCT04182633|Combination Product|vancomycin, Miralax, intestinal microbiota|vancomycin for 14 days, then Miralax for 1 day, then intestinal microbiota (high dose for 2 days, then maintenance dose for 12 weeks)
15833361|NCT04177706|Drug|Placebo|Participants receiving the placebo study medication will receive saline twice per week for four weeks under clinical supervision.
15832730|NCT04182633|Combination Product|placebo vancomycin, Miralax, placebo intestinal microbiota|placebo vancomycin for 14 days, then Miralax for 1 day, then placebo intestinal microbiota (high dose for 2 days, then maintenance dose for 12 weeks)
15832731|NCT04182620|Device|renal denervation|Renal denervation using the Paradise renal denervation system - a dedicated RDN catheter that delivers a circumferential ring of ablative ultrasound energy
15832732|NCT04182620|Device|Catheter ablation|Catheter ablation - one of the most common procedures performed by Cardiac Electrophysiologists for atrial fibrillation
15832733|NCT04182607|Procedure|kidney transplant|Clinical data will be collected from electronic medical records (EMRs) on donors and recipients who underwent a minimally invasive kidney transplantation procedure
15832734|NCT04182594|Drug|Degarelix|Treatment will start with two injections of 120 mg each followed by maintenance of a single injection of 80 mg administered every 28 days
15832735|NCT04182594|Drug|GnRH agonist|GnRH agonist at the discretion of the treating Urologist/Oncologist for 1 year
15832736|NCT04182581|Biological|BCMA/CD19 Dual-Target CAR-T|BCMA/CD19 Dual-Target CAR-T target both BCMA and CD19. The subjects will receive CAR-T as one dose. The dosage ranges from 5×10^4 to 3×10^5 CAR+T/Kg.
15832737|NCT04182568|Drug|nab-paclitaxel followed by anthracycline and cyclophosphamide|nab-paclitaxel 260mg/m2 for every 2 weeks followed by anthracycline and cyclophosphamide
15832738|NCT04182568|Drug|Docetaxel followed by anthracycline and cyclophosphamide|Docetaxel 100 mg/m2 for for every 2 weeks followed by anthracycline and cyclophosphamide
15832739|NCT04182555|Device|Bilirubin estimates from Smartphone Application|Bilirubin estimates through color analysis of digital images obtained through smartphone application.
15832740|NCT04182555|Diagnostic Test|Bilirubin concentration measured in standard blood samples|Bilirubin measured in total serum bilirubin.
15832741|NCT04182555|Device|Bilirubin estimates from standard transcutaneous device|Bilirubin estimates performed by transcutaneous device ( Dräger JM-105)
15832742|NCT04182555|Other|Visual assessment of jaundice|Degree of jaundice will be assessed by Kramer scale
15832743|NCT04182542|Device|Radiofrequency|The volunteers will receive radiofrequency (TECAR-BTL® device, with epidermal temperature above 40ºC) in the right infraumbilical abdominal region, with an application time of 10 minutes (2 minutes per applicator area) and the left region will be used as control. A single session will be held. After approximately 30 days of this application the material for histological analysis will be collected during the surgical act, at which point the skin and the subcutaneous tissue of the infraumbilical region are discarded by the surgeon.
15832744|NCT04182529|Device|Photoneuromodulation therapy|low-level LED near-infrared (670-810nm) including MedX Health Model 1100 or WiseFori5-3800
15832745|NCT04182529|Other|Sham|Sham, no active stimulation will be given to subjects
15832746|NCT04182516|Drug|NMS-03305293|All patients will receive NMS-03305293 administered orally once daily on Days 1-21 in repeated 4-week cycles.
15832747|NCT04182503|Other|No intervention|This is a multi-city observational cohort study without intervention.
15832748|NCT04182490|Biological|LMN-101|VHH-derived binding protein designed to bind and inhibit FlaA, flagellin filament protein of Campylobacter jejuni, delivered in whole spray-dried, spirulina biomass
15832749|NCT04182477|Diagnostic Test|Montreal Cognitive Assessment|Neuro-cognitive test evaluating general mental status and performance
15832750|NCT04182464|Other|Sucralose|Food additive used to replace sugar providing a sweet taste without calories
15832751|NCT04182464|Other|Placebo|Cornstarch without significant physiological effects
15832752|NCT04182451|Device|Meso Wound Matrix|"Subjects who meet eligibility criteria will receive standard of care and Meso Wound Matrix.
~The standard of care therapy in this study is offloading of the DFU, appropriate sharp or surgical debridement, and aggressive infection management with the use of appropriate dressings. Total contact casting or fixed ankle walker will be used for off-loading. Wound Matrix is an acellular scaffold to reinforce and repair soft tissue defects. Subjects may receive up to eight applications of Meso Wound Matrix. Subjects whose study ulcer does not heal after eight applications will receive only SOC treatment for 4 additional weeks."
15832753|NCT04182438|Dietary Supplement|Low potassium content vegetables|use low-potassium content vegetables
15832754|NCT04182425|Other|Infant formula|Healthy full-term infants fed on an infant formula marketed on the French market
15832755|NCT04182412|Procedure|ARD|surgical reconstruction with laparoscopic technique
15832756|NCT04182399|Drug|Zonisamide Capsules|anti-epileptic drug that recently used as add on therapy of wearing off and fluctuation complications of dopaminergic drugs in PD patients
15832757|NCT04182386|Procedure|Portal vein embolization|Selective preoperative portal vein embolization
15832758|NCT04182373|Drug|Antithrombin gamma|Intravenous infusion, once a day, 7 days
15832759|NCT04182373|Drug|physiological saline|Intravenous infusion, once a day, 7 days
15832761|NCT04182347|Other|Health Research ToolKit Development|"The Toolkit will be an accessible, structured process for people with IDD and people with IDD's paid and unpaid caregivers to be engaged partners. Learning activities are focused on leadership, information about research, health for individuals with IDD. Learning activities will include topics:
~What is health research? What is the health research process? How can individuals with IDD be involved in health research? Where is research happening? How to think like a researcher. Creating health stories for research and care advocacy.
~The learning activities will teach individuals with IDD information and allow participants to practice the learning."
15832762|NCT04182334|Other|Slow Tempo Music|For up to seven days, enrolled subjects will receive one-hour slow tempo music listening sessions twice daily through noise-cancelling headphones.
15832763|NCT04182334|Other|Attention Control|Subjects will receive a noise cancellation headphone-applied condition identical to the music intervention experimental treatment in twice daily one hour-sessions for up to seven days.
15832764|NCT04182321|Drug|Metformin & Entecavir|Metformin (sustained release tablet, 1000 mg, QD, 24 weeks) and Entecavir (tablet, 0.5 mg, QD, ongoing treatment)
15832765|NCT04182321|Drug|Placebo & Entecavir|Placebo (two tablets, QD, 24 weeks) and Entecavir (tablet, 0.5 mg, QD, ongoing treatment)
15832766|NCT04182308|Other|dissection|Dissection of lisfranc ligament from 30 aldult Vietnamese cadavers's foot
15832767|NCT04182295|Device|acupuncture|A sterilised stainless steel needle (diameter 0.25mm X length 40mm, Dongbang Acupuncture Inc., Boryeong, Chungchenongnam-do, Korea) will be given at PC3, LI4, LI11, and LU5 of non-dominant arm for 15 minutes once a day for 3 days (immediately after inducing delayed onset muscle soreness (DOMS), and 2 consecutive days after inducing DOMS).
15832768|NCT04182295|Device|Park Sham Needle|A Park Sham Needle (Meridius Medical Ltd. & DongBang Acuprime Ltd., Exeter, UK), non-penetrating sham acupuncture, will be given at two points on the belly of biceps brachii, 1 cun proximedially from LI11, and 1 cun laterally from PC3 of non-dominant arm for 15 minutes once a day for 3 days (immediately after inducing delayed onset muscle soreness (DOMS), and 2 consecutive days after inducing DOMS).
15832769|NCT04182282|Behavioral|CARES Dementia-Friendly Hospitals Online Training and Certification Program|The CARES Dementia-Friendly Hospitals Online Training program is a 4-course, 16-module, video-based training program for hospital staff members. The CARES Dementia-Friendly Hospitals Online Certification Program is a 100-point certification exam evaluating knowledge from the online training protocol.
15832770|NCT04182269|Other|Measurement of functional exercise capacity|The Glittre Activities of Daily Living (ADL) Test was used to evaluate functional exercise capacity.
15832771|NCT04182256|Device|MS|Magnetic Spiderman (MS) is a novel surgical instrumentIt. It consists of a circular neodymium iron boron magnet packed in a stainless-steel case with a spring and a jagged clamp, which gives it a spider-like appearance.
15832772|NCT04182243|Other|Evaluation of job satisfaction in emergency health care providers by questionnaire|
15832773|NCT04182230|Other|No intervention. This study was an evalution with no intervention.|Not an interventional study
15832774|NCT04182217|Other|Epidemiological description|Description of the characteristics of Peritonitis in Haiti
15832775|NCT04182204|Drug|Polatuzumab Vedotin|polatuzumab vedotin 1.8 mg/kg for a maximum dose of 240 mg/cycle IV on Day 1 of each 21-day cycle for up to 8 cycles.
15832776|NCT04182204|Drug|Rituximab|rituximab 375 mg/m2 IV on Day 1 of each 21-day cycle for up to 8 cycles.
15832777|NCT04182204|Drug|Gemcitabine|gemcitabine 1000 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycles.
15832778|NCT04182204|Drug|Oxaliplatin|oxaliplatin 100 mg/m2 IV on Day 2 of each 21-day cycle for up to 8 cycle.
15832779|NCT04182191|Drug|Tenoxicam|After extraction of at least one third molar, 89 patients will be treated with tenoxicam (20 mg once daily for 4 days) for pain control, collect the saliva to be genotyped and phenotyped for CYP2C9 (by PCR) and their post-operative notes (pain, swelling, trismus, temperature) will be analyzed.
15832780|NCT04182178|Other|10 years follow up|Questionnaires
15832781|NCT04182165|Device|Gili BioSensor System/ Gili Pro X BioSensor System|Usability study
15832782|NCT04182152|Device|Indocyanine green (ICG)|Indocyanine green (ICG) was diluted with saline to 0.5mg/mL, and injected 0.6mL/site.
15832783|NCT04182152|Device|Electromagnetic navigation bronchoscopy|Electromagnetic navigation bronchoscopy (ENB) allows physicians to access peripheral lung nodules with high accuracy and provides a working channel for ICG injection.
15832784|NCT04182152|Device|Hook wire|Hook wire is a puncture locating needle with a hook head that is about 1 cm in length and 30 cm metal wire behind. Through the puncture path planned based on CT scan, hook wire puncture percutaneously into the chest cavity to reach the lesion for localization.
15832785|NCT04182139|Other|Static Stretching Exercise|Each intervention group received a different duration and intensity of static stretching exercise protocol.
15832786|NCT04182126|Other|Regular long-lasting insecticidal nets|Olyset nets: containing 2% permethrin or PermaNet 2.0 containing 1.8 and 1.4 g/kg, respectively, for 75 and 100 denier yarn
15832787|NCT04182126|Other|LLIN plus Piperonyl butoxide-treated LLIN|Olyset Plus: containing 2% permethrin and 1% PBO
15832788|NCT04182126|Other|Long-lasting microbial larvicide|Semi-permanent and permanent habitats will be treated with FourStar® 180-day Briquets using the recommended dosage of 100 ft2 water surface per briquet
15832789|NCT04182126|Other|Indoor residual spraying with micro-encapsulated pirimiphos-methyl|each dwelling's interior walls and ceilings will be sprayed with micro-encapsulated pirimiphos-methyl at the recommended dosage of 1g/m² and at the recommended frequency of once a year
15832790|NCT04182113|Device|1 Hz rTMS|Subjects will receive one session of low frequency rTMS within the following stimulation parameters: Continuous 20-minute train of 1 Hz rTMS, at 120% of MT, for a total of 1200 pulses.
15832791|NCT04182113|Device|20 Hz rTMS|Subjects will receive one session of high frequency rTMS within the following stimulation parameters: 20 Hz, at 120% of MT, 60 trains (1.0 second per train), 20 pulses per train, inter-train interval of 15 seconds, for a total of 1200 pulses over 16 minutes.
15832792|NCT04182113|Device|Sham|Sham stimulation session targeting the precuneus. The active and sham functions share the same acoustic properties and sham mimics cutaneous stimulation, facilitating double-blinding.
15832793|NCT04182100|Drug|P1101|P1101 (ropeginterferon alfa-2b) will be administered subcutaneously every 2 weeks at the starting dose of 100 μg every two weeks (or 50 μg in patients under another cytoreductive therapy). The dose should be gradually increased by 50 μg every two weeks (in parallel, other cytoreductive therapy should be decreased gradually, as appropriate) until stabilization of the hematological parameters is achieved (hematocrit <45%, platelets <400 x 10^9/L and leukocytes <10 x 10^9/L). The maximum recommended single dose is 500 μg injected every two weeks. The dose will be maintained at the highest level which can be tolerated and delivers best possible disease response.
15832794|NCT04182100|Drug|Low-dose aspirin|Low-dose aspirin (acetylsalicylic acid) (75-150 mg/day) will be given as background therapy during the 12 months of study treatment, unless contraindicated.
15832795|NCT04182100|Procedure|Phlebotomy|Phlebotomy is performed aiming at a hematocrit < 45%. When the hematocrit value is 45% or higher, phlebotomy is performed. The volume of phlebotomy per procedure should be 200 to 400 mL while monitoring the circulatory dynamics such as blood pressure and pulse. In the elderly and patients with cardiovascular disorders, a small volume (100-200 mL) should be considered to avoid rapid changes in hemodynamics.
15832796|NCT04182087|Behavioral|Cognitive tasks|Attention, language, memory, decision-making or executive functions
15832825|NCT04181840|Diagnostic Test|Anorectal manometry|During V1 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.
15833060|NCT04180085|Drug|Belatacept Injection|9 injections of belatacept at 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months 11 months and 12 months post graft
15832797|NCT04182061|Behavioral|The AMTE protocol|The AMTE program is an adaptation of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A; Ehrenreich-May et al., 2018) to be applied as an internet-based protocol. Like the UP-A, the program AMTE implements a set of core principles to address common factors underling youth anxiety and depressive symptoms. It includes the following 10 modules: (1) Understanding emotional problems and disorders, (2) Getting to know your emotions and behaviors, (3) Enjoy your positive activities, (4) Mindful emotion awareness, (5) Being flexible in your thinking, (6) Confronting physical sensations, (7) Situational emotion exposure, (8) How to regulate the emotional avoidance, (9) Respiratory relaxation training, and (10) Relapse prevention.
15832798|NCT04182035|Other|patient-tailored therapy|The subjects in the PTT group will receive the individual tailored treatment program combining best evidence active and passive treatment strategies (manual therapy, individual exercises) in combination with education tailored to the individual situation of the patient and selected home exercises. 9 individual therapy sessions will be performed, in combination with 9 additional home exercise sessions.. NRS and NDI-scores will be monitored before every treatment. The therapist will register when the cut-off score of 30% NDI reduction is present in order to determine the evolution in pain/disability reduction. The importance of self-efficacy will be emphasized and tailored home-exercises will be monitored and adjusted every week.
15832799|NCT04182035|Other|Non-patient tailored therapy: generalized exercise program|The NPTT will receive an individual (hands-off) treatment, which includes an active neck exercise program, non-tailored education and non-tailored home exercises, according to a previously published program with good results.53 The sessions will be performed once a week under supervision (9 therapy sessions, standard exercise program) and once a week by the patient at home (9 home exercise sessions, standard exercise program).
15832800|NCT04182035|Other|Education|Education considering neck pain information
15832801|NCT04182022|Behavioral|Contingency management: Contingent incentives|Monetary incentives are delivered to participants contingent upon on- time breathalyzer submissions and verified abstinence from alcohol.
15832802|NCT04182022|Behavioral|Contingency management: Noncontingent incentives|Monetary incentives are delivered to participants contingent upon on- time breathalyzer submissions only with no contingency on alcohol use.
15832803|NCT04182009|Device|Omron NE-U17 Ultrasonic nebuliser|The Omron Ultrasonic nebuliser dispenses sterile saline from a medication cup as an aerosol, which is inhaled.
15832804|NCT04182009|Device|Akita Jet Inhalation System|The Akita Jet Inhalation System is a breath actuated nebuliser, which works with a positive pressure.
15832805|NCT04181996|Drug|Colchicine Oral Product|Patients will be randomized to receive either placebo or colchicine
15832806|NCT04181996|Drug|Placebo oral capsule|Patents will be randomized to receive either placebo or colchicine
15832807|NCT04181983|Other|Personalized exercise program|Home-based personalized exercise program using a smart phone app
15832808|NCT04181983|Other|WHO exercise guidelines|Standard exercise counselling according to WHO guidelines
15832809|NCT04181970|Other|Quality assessment|There is no intervention on study subjects. A tumor review will be performed by expert centers.
15832810|NCT04181957|Drug|Placebo oral tablet|Participants take one dose of placebo (lactose) tablet.
15832811|NCT04181957|Drug|Lisdexamfetamine Dimesylate|Participants take one 50mg tablet of lisdexamfetamine dimesylate once.
15832812|NCT04181944|Other|Exercise Treatment Group|be specific
15832813|NCT04181931|Procedure|neo-TACE-HAIC+Surgery|transartery chemoembolization with lipiodol and EADM, FOLFOX (Oxa 85mg/m2 2h+CF 400mg/m2 2h+5FU 400mg/m2 10min+5FU 1200mg/m2 23h)-based artery infusion chemotherapy, followed by hepatic resection
15832814|NCT04181931|Procedure|Surgery alone|hepatic resection remove the liver tumor and portal vein tumor thrombus
15832815|NCT04181918|Behavioral|AOT|During action observation, participants observe different daily actions (e.g. reading a newspaper; drinking an espresso) divided into up to four motor segments.
15832816|NCT04181918|Behavioral|MI|During motor imagery, participants imagine themselves performing the same daily actions as in AOT in the absence of motor output
15832817|NCT04181905|Other|Questionnaire|Firstly, demographic information (name-surname, date of birth, gender, age, height, body weight, dominant hand, family structure, social security, educational status, occupation, smoking, alcohol use, assistive device drug use, resume, surname, complaints). Data collection tools will then be applied to patients by face to face interview technique. Evaluation of kinesiophobia Assessment of quality of life in asthma patients with TAMPA questionnaire Assessment of physical activity level with Asthma Quality of Life Questionnaire (AQLQ) Assessment of physical activity level with International Physical Activity Questionnaire-Short Form (IPAQ) is planned.
15832818|NCT04181892|Procedure|Coronally advanced flap + connective tissue graft|connective tissue graft covered by a coronally advanced flap with connective tissue graft apical of the cementoenamel junction level
15832819|NCT04181879|Behavioral|Intervention|"GPs allocated to the intervention will be given access to the intervention package and asked to perform medication reviews with approximately 10 patients on two occasions (initial and 6-months follow-up).
~The intervention package consists of two components: (a) an online video demonstrating how GPs can improve appropriate polypharmacy during typical consultations with older patients; (b) a patient recall process (appointment with the GP for a medication review).
~GPs will be asked to schedule appointments with consenting patients (telephone or online consultations where a face-to-face consultation is not possible). During these appointments, GPs will undertake medication reviews ('a structured, critical examination of a person's medicines with the objective of reaching an agreement with the person about treatment, optimising the impact of medicines, minimising the number of medication-related problems and reducing waste')."
15832820|NCT04181853|Other|exercise|aerobic exercise
15832821|NCT04181840|Diagnostic Test|Blood and faeces tests|During V1 - Laboratory tests, particularly for calprotectin concentration assessment
15832822|NCT04181840|Device|Impedance spectroscopy test|During V1 - the electrical impedance of anal sphincter muscles will be measured
15832823|NCT04181840|Diagnostic Test|Full gynecological and proctological examination|During V1 and V2 - Examination with a gynecological speculum, Two-handed examination, Rectal examination, and Anoscopy
15832824|NCT04181840|Diagnostic Test|Transanal ultrasonography|During V1 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.
15832936|NCT04181112|Biological|Fecal Microbiota Transplantation (FMT)|FMT using retention enema
15832826|NCT04181840|Other|Determining the degree of sphincter injury|During V2 - conducting the examination will finally determine the extent of sphincter damage, present the patient with therapeutic options and decide on the treatment or rehabilitation of sphincter.
15832827|NCT04181827|Drug|JNJ-68284528|Cilta-cel infusion will be administered at a target dose of 0.75 * 10^6 CAR-positive viable T cells/kilogram (kg).
15832828|NCT04181827|Drug|Pomalidomide|Pomalidomide 4 mg will be administered orally.
15832829|NCT04181827|Drug|Bortezomib|Bortezomib 1.3 milligram per meter square (mg/m^2) will be administered subcutaneously (SC).
15832830|NCT04181827|Drug|Dexamethasone|Dexamethasone 20 mg/day (10mg/day for participants >75 years of age) (on bortezomib treatment days and the days following bortezomib treatment) will be administered orally in PVd treatment; and orally or intravenous (IV) at 40 mg weekly (20mg weekly for participants >75 years of age) in DPd treatment.
15832831|NCT04181827|Drug|Daratumumab|Daratumumab 1800 mg will be administered SC.
15832832|NCT04181814|Device|Ultrasound|Use ultrasound to assess gastric contents in diabetic patients before anesthesia
15832833|NCT04181801|Procedure|Subtotal cholecystectomy|a surgical procedure in which more than the top half of the gallbladder is removed
15832834|NCT04181788|Drug|PF-06801591|A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PDL1/ PD-L2.
15832835|NCT04181775|Diagnostic Test|ADE-RED scoring tool|The ADE-RED scoring tool will reduce the incidence of future visits to the ED or future admissions by identifying patients who are at high risk for ADE-related readmissions.
15832837|NCT04181749|Drug|aspirin and atorvastatin|Patients will be randomized and prescribed either no treatment or aspirin 75mg and Atorvastatin 40mg
15832838|NCT04181736|Drug|Guanfacine Pill|Guanfacine immediate release, sold under the brand name Tenex among others, is a medication used to treat high blood pressure and off-label to treat attention deficit hyperactivity disorder (ADHD). It is taken by mouth and will be compounded by a pharmacy to the required doses used in this study.
15832839|NCT04181736|Drug|Placebo|Placebo masked to mirror the treatment drug dose regimen.
15832840|NCT04181723|Drug|Trofinetide|Trofinetide solution administered based on the subject's weight at Baseline, twice daily for 12 weeks
15832841|NCT04181723|Other|Placebo|Trofinetide placebo solution administered based on the subject's weight at Baseline, twice daily for 12 weeks
15832842|NCT04181710|Procedure|Kidney transplant|Organ preserved in preservation solution
15832843|NCT04181697|Device|PA measurement with Fitbit Charge 3|Measurement of PA with Fitbit for all participants and controls.
15832844|NCT04181697|Device|PA measurement with Fitbit and ActiGraph GT3X|Measurement of PA with ActiGraph for a subgroup of 20 participants.
15832845|NCT04181684|Device|Procedure: LITT|This procedure is done under MRI guidance and employs low-powered thermal energy to achieve tumor ablation through coagulation.
15832846|NCT04181684|Radiation|Hypo-Fractionated Radiation Therapy|Treatments will be delivered once daily on consecutive treatment days (typically 5 fractions per week). Radiation therapy simulation is to be performed within 10 days of the LITT procedure.
15832847|NCT04181671|Other|Low Resistance training with venous blood flow restriction|"Total 20 males will participate in this group after warmup , Blood flow restriction will be provided through sphygmomanometer optimum pressure will be measured through following formula occlusion pressure (mmHg) = 0.514 (SBP) + 0.339 (DBP) + 1.461 (Arm circumference) + 17.236 then 30% of 1RM will be used for training . The standard protocol will be used which is four sets (1st set-30 repetitions, 2nd set-15 repetitions, 3rd set-15 repetitions, and 4th set-15 repetitions) with 30-60 s of interval between sets. ( the cuff must be deflated between sets of exercise) for 8 weeks (24) sessions on non-consecutive days. participants will be re-assessed for all baseline variables after 8 weeks of training biceps curls will be used for training.
~Heart Rate and oxygen saturation will be measured during the session through Pulse oximeter"
15832848|NCT04181671|Other|High Resistance training|Total 20 males will participate in this group after warm up. 80% of 1RM will be used for training, 3 sets of 8 repetitions will be used with 30-60 s of interval between sets. for 8 weeks (24) sessions on non-consecutive days.No blood flow restriction will be applied to this group Participants will be re-assessed for all baseline variables after 8 weeks of training. Bicep curls will be used for training.
15832849|NCT04181658|Other|Real tDCS and Physical Therapy|The participant will receive 20-minute sessions of real tDCS before each physical therapy visit for up to 10 combined sessions, over approximately 6 weeks.
15832850|NCT04181658|Other|Sham stimulation and Physical Therapy|The participant will receive 20-minute sessions of sham stimulation before each physical therapy visit for up to 10 combined sessions, over approximately 6 weeks.
15832851|NCT04181645|Drug|Biological: SHR-1210 Drug: Gemcitabine Drug:Paclitaxel-albumin|SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody. Gemcitabine Other Name: Gemcitabine Hydrochloride for Injection Paclitaxel-albumin Other Name: Paclitaxel-albumin Injection
15832852|NCT04181632|Device|Buzzy Bee with Ice pack|Buzzy uses natural pain relief to block needle pain for blood draws and shots. This intervention will be used with an ice pack.
15832853|NCT04181632|Device|Buzzy Bee without Ice pack|Buzzy uses natural pain relief to block needle pain for blood draws and shots. This intervention will be used without an ice pack.
15832854|NCT04181632|Device|Shot Blocker|Shot Blocker is a device that instantly alleviates the pain and anxiety of needle injections when pressed firmly against the skin at the injection site.
15832855|NCT04181619|Dietary Supplement|Coffeeberry beverage|One exposure of 300 mg coffeeberry extract in a 300 ml flavored still beverage prior to exercise session
15832856|NCT04181619|Other|Comparator beverage|One 300 ml still beverage, color and flavor matched to experimental beverage prior to exercise session
15832863|NCT04181593|Drug|Omega 3 fatty acid|Omega 3 fatty acid Softgels
15832864|NCT04181593|Drug|Placebos|Mineral oil Softgels
15832865|NCT04181580|Device|Made-to-measure compression garment|Made-to-measure compression garment
15832866|NCT04181567|Other|electroconvulsive therapy|electroconvulsive therapy 2 times weekly
15832867|NCT04181567|Drug|agomelatine|agomelatine
15832868|NCT04181567|Drug|Placebo|placebo
15832869|NCT04181554|Other|Measurement of postural stability|The postural stability will assess by using Biodex balance system.
15832870|NCT04181541|Procedure|Provider type: Physicians|In this cohort, women will receive second trimester medical abortion care from physicians
15832871|NCT04181541|Procedure|Provider type: Midlevel Providers|In this cohort, women will receive second trimester medical abortion care from midlevel providers.
15832872|NCT04181528|Device|Total knee arthroplasty implant|In patients undergoing unilateral TKA, decide the implant of TKA (anatomically aligned or conventional TKA implant) will be decided using ramdon number table
15832873|NCT04181515|Drug|Placebo oral tablet|placebo stressor
15832874|NCT04181515|Drug|Yohimbine + Hydrocortisone|Yohimbine 54mg + Hydrocortisone 20mg
15832875|NCT04181515|Device|sham rTMS|sham rTMS (inactive coil)
15832876|NCT04181515|Device|active rTMS|active rTMS (10 Hz dlPFC stimulation in group 1; 1 Hz mPFC stimulation in group 2)
15832877|NCT04181502|Procedure|pneumatic tourniquet|a pneumatic tourniquet around 200 mmHg after venous chase of the lower limb, during 5 minutes then deflated. Repeated twice after general anaesthesia and prior to incision.
15832878|NCT04181502|Other|No inflation|No inflation of the pneumatic tourniquet placed on the lower limb
15832879|NCT04181489|Drug|Sintilimab|Sintilimab 200mg d0
15832880|NCT04181489|Drug|Rituximab|Rituximab 375 mg/m2 d0
15832881|NCT04181489|Drug|Cyclophosphamide|Cyclophosphamide 750 mg/m2 d1
15832882|NCT04181489|Drug|Doxorubicin|Doxorubicin 50 mg/m2 d1
15832883|NCT04181489|Drug|Vincristine|Vincristine 1.4mg/m2 (maximum 2mg) d1
15832884|NCT04181489|Drug|Prednisolone|Prednisolone 60mg/m2 d1-5
15832885|NCT04181476|Drug|Sunscreening Agents|Four different sunscreens
15832886|NCT04181463|Drug|Isopropyl Alcohol|Given via nasal inhalation
15832887|NCT04181463|Other|Placebo|Given via nasal inhalation
15832888|NCT04181463|Other|Questionnaire Administration|Ancillary studies
15832889|NCT04181450|Other|Determination of the Cut-off Scores of Biodex Balance System|Based on the findings of the Sherafat et al. (Sherafat, S., Salavati, M., Takamjani, I. E., Akhbari, B., Mohammadirad, S., Mazaheri, M., & Negahban, H. (2013). Intrasession and intersession reliability of postural control in participants with and without nonspecific low back pain using the Biodex Balance System. Journal of manipulative and physiological therapeutics, 36(2), 111-118.) related to intrasession and intersession reliability of BBS in patients with NSLBP12, in the present study, one stability level (Level 5; ICC ≥0.70) and two conditions (eyes-open and eyes-closed) will be selected as testing procedure. All postural assessments will be performed during bilateral stance for a period of 30 seconds.
15832890|NCT04181437|Drug|NVP-1203-R1|1 tablet, Single oral dosing
15832891|NCT04181437|Drug|NVP-1203-R2|1 tablet, Single oral dosing
15832892|NCT04181437|Drug|NVP-1203-R1 and NVP-1203-R2|NVP-1203-R1,1 tablet and NVP-1203-R2, 1 tablet, co-administration, single oral dosing
15832893|NCT04181424|Behavioral|Diabetes Education Plus Monthly Food Vouchers|Individuals assigned to this group will receive diabetes education and skills training and monthly food vouchers for use at local Farmer's markets mailed to their home.
15832894|NCT04181424|Behavioral|Diabetes Education Plus Combination of Monthly Food Vouchers and Stock Boxes|Individuals assigned to this group will receive diabetes education and skills training, monthly food vouchers for use at local Farmer's markets mailed to their home, and monthly stock boxes with diabetes appropriate food items mailed to their home.
15832895|NCT04181424|Behavioral|Diabetes Education Only|Individuals assigned to this group will receive diabetes education and skills training but will not receive food supplementation.
15832896|NCT04181424|Behavioral|Diabetes Education Plus Monthly Stock Boxes|Individuals assigned to this group will receive diabetes education and skills training and monthly stock boxes with diabetes appropriate food items mailed to their home.
15832897|NCT04181398|Diagnostic Test|Anthropometry|"Actual Height and weight
~Calculated BMI from measured weight and height.
~Pubertal development (Tanner stage)
~Waist circumference
~Skin fold measurement (Triceps and Subscapular)
~Waist-to-height ratio will be calculated from measured height and waist circumference."
15832898|NCT04181398|Diagnostic Test|Blood pressure|Blood pressure will be measured using an oscillometric, electronic device (Mindray). The blood pressure will be measured 3 times; the first measurement will not be taken into account and the mean of the second and third measurement will be considered as the real blood pressure.
15832899|NCT04181398|Diagnostic Test|Peripheral arterial tonometry|The investigator will measure the pulse wave amplitude by using a finger plethysmograph (peripheral arterial tonometry). The investigator will use the EndoPAT device from Itamar Medical Ltd. At the end of the examination, the participants will be asked to give a VAS-score (Visual Analogue Pain scale).
15832900|NCT04181398|Other|Questionnaire|General questionnaire on cardiovascular risk factors
15832901|NCT04181398|Diagnostic Test|Blood sample|Blood sample for hs-CRP
15832902|NCT04181385|Drug|Olanzapine 10 milligram|Oral olanzapine capsule
15832903|NCT04181385|Drug|Bromocriptine 5 milligram|Oral bromocriptine capsule
15832904|NCT04181385|Drug|Placebo oral tablet|oral placebo capsules
15832905|NCT04181372|Drug|Anlotinib hydrochloride|Anlotinib hydrochloride was given 12mg once daily for two weeks, stop for one week, each 3-week cycle for 2 cycles.
15833059|NCT04180098|Other|No intervention|Participants in the control group are placed on a waiting list.
15832906|NCT04181372|Drug|platinum-based chemotherapy medicine|(1)Carboplatin was given dosed to an AUC of 6 i.v. injection on day 1, paclitaxel was given 150 mg/m^2 i.v. on day 1, every 21 days for 2 cycles.Or(2) Carboplatin was given dosed to an AUC 5 or Cisplatin was given 75 mg/m^2 ,i.v. on day 1, pemetrexed was given 500 mg/m^2 i.v. on day 1 for nonsquamous, every 21 days for 2 cycles.Or(3) Cisplatin was given 75 mg/m^2 i.v. on day 1; docetaxel was given 75 mg/m^2 i.v. on day 1 ,each 21-day cycle for 2 cycles.
15832907|NCT04181359|Drug|Nitric Oxide|Inhaled nitric oxide, which consists of breathing medical grade air (21% O2) with 40 parts per million of nitric oxide.
15832908|NCT04181359|Drug|Placebo|Inhaled placebo, which consists of breathing medical grade air (21% O2).
15832909|NCT04181346|Drug|Pregabalin|antipsychotic
15832910|NCT04181346|Drug|Placebo|Placebo
15832911|NCT04181320|Device|Venous Leg Ulcer Standard of Care with Granulox|Granulox will be added as an adjunct therapy to defined standard of care in subjects with predominantly venous leg ulcers.
15832912|NCT04181307|Behavioral|BE-EHR module|The BE-EHR module includes six components: 1) a tailored advisory for patients over 75 with diabetes, 2) medication refill protocol with information on Choosing Wisely guidelines, 3) pre-population of the medication preference list with metformin, 4) lab result protocol with information on Choosing Wisely guidelines, 5) peer comparisons regarding performance meeting guidelines, and 6) media campaign with information about Choosing Wisely guidelines. The set of nudges is referred to collectively as the BE-EHR module.
15832913|NCT04181294|Behavioral|Family meetings using time limited trials as default ICU communication and care planning approach|Providers will be trained using didactics, focus groups, and simulations using actors as family members. A TLT protocol and checklist will be used to facilitate family meetings. A coordinator will schedule family meetings. Routine feedback sessions will be held with the local champions.
15832914|NCT04181294|Behavioral|Usual practice|Baseline practice of ICU communication and care planning
15832915|NCT04181281|Diagnostic Test|Contrast enhanced ultrasound|This is a regular ultrasound scanner used with an ultrasound contrast agent injected through veins to allow for kidney perfusion acquisition.
15832916|NCT04181281|Diagnostic Test|Arterial Spin Labelling -Magnetic Resonance Imaging|Arterial spin labelling is an MRI technique allow for measuring tissue perfusion. It uses magnetically labelled arterial blood water protons as a tracer.
15832917|NCT04181268|Device|Percutaneous coronary Intervention|Calcified plaque modification during percutaneous coronary intervention
15832918|NCT04181255|Drug|Curosurf|This arm will consist of a single dose of Curosurf (200 mg/kg) that will be given in the Pediatric Cardiothoracic Unit (PCTU) after surgery once the subject has reached a normalized body temperature.
15832919|NCT04181255|Drug|Sham|This arm will consist of a single dose of sham (air) that will be given through the endotracheal tube in the Pediatric Cardiothoracic Intensive Care Unit after surgery once the subject has reached a normalized body temperature.
15832920|NCT04181229|Procedure|Deep brain stimulation|Patients will receive surgical implantation of the Medtronic DBS device (Device # 37601). Two (2) electrodes will be implanted bilaterally in the centromedian nucleus.
15832921|NCT04181216|Device|Anatomically aligned total knee arthroplasty implant|In same patient, one total knee arthroplasty using anatomically aligned total knee arthroplasty implant Other total knee arthroplasty using conventional total knee arthroplasty implant
15832922|NCT04181203|Drug|Apalutamide|"240 mg PO daily should start the same day as the first LHRHa administration for 6 months.
~months."
15832923|NCT04181203|Radiation|Salvage radiotherapy (SRT)|"The SRT treatment will be administered to a total dose of 66 Gy (in 33 fractions of 2 Gy) directed at the prostate bed with an additional 56.1 Gy (in 33 fractions of 1.7 Gy) directed at the pelvis region. The pelvis will be irradiated in all patients.
~An additional simultaneously integrated boost of 69.3 Gy (in 33 fractions of 2.1 Gy) can be delivered to a local relapse based on Positron Emission Tomography - Computed Tomography (PET/CT) and Magnetic Resonance Imaging (MRI) images."
15832924|NCT04181203|Drug|Luteinising Hormone Releasing Hormone agonist (LHRHa)|Doses of LHRHa may vary due to availability of different brand names and pharmaceutical forms. It will be left to the discretion of the investigator.
15832925|NCT04181190|Diagnostic Test|Total IgE|Levels of total IgE before biological treatments and at 4±2 months of treatments
15832926|NCT04181190|Diagnostic Test|Blood cell counts|White Blood Cell Count and Differential (and in particular the levels of total leucocytes, lymphocytes, eosinophils and basophils)
15832927|NCT04181190|Diagnostic Test|Asthma control assessment|Levels of asthma control assessed by asthma control questionnaire (ACT) before initiation of biological treatments and at 4± months of treatments
15832928|NCT04181190|Diagnostic Test|lung function tests|Lung function tests performed before initiation of biological treatments and at 4± months of treatments
15832929|NCT04181177|Other|Cosmetic product|"Cosmetic balm: application twice daily on the whole body in sufficient quantity to cover all the xerosis areas. It contains an I-modulia(r) complex which decreases the sensation of itching, CER-OMEGA which are lipids similar to those of the skin, help repair and nourish the skin, finally Avène Thermal Spring Water which have soothing and softening properties.
~Targeted education action consist in advices and preventive measures (including hygiene) regarding xerosis and associated dermatological signs / symptoms. Emollient and application tips and other supportive care tips will be provided. The targeted educational action will be monitored by the medical and paramedical teams (specialized nurses)."
15832930|NCT04181164|Other|Microindentation|Microindentation is a new technology directly measuring bone strength by a minimal invasive technique.
15832931|NCT04181164|Other|High resolution peripheral quantitative computed tomography (HRpQCT)|HRpQCT scan can assess the cross-sectional geometry of the bone and is an appropriate investigation to evaluate bone quality.
15832932|NCT04181164|Biological|Biochemical analysis of different bone markers.|Measurement of different bone markers by biochemical analysis of blood samples.
15832933|NCT04181151|Other|Electromyographic device|An 8-channel surface EMG system (Noraxon Telemyo DTS system, Scottsdale, USA) will be used to measure signals from muscles during surface electromyography measurements.
15832934|NCT04181125|Other|Biodex Balance System|For the computerized evaluation of postural control, Biodex Balance System will be used.
15832935|NCT04181125|Other|Balance Error Scoring System (BESS)|For the clinical evaluation of postural control, the Modified Balance Error Scoring System (BESS) will be used.
15832937|NCT04181099|Other|Implant neck surface|The biofilm formation is tested on discs manufactured of zirconia with different surfaces in vivo using orthodontic devices that the participants carry over 24h
15832938|NCT04181086|Procedure|surgical excision of intracranial cavernoma|microvascular excision of intracranial cavernoma
15832939|NCT04181073|Device|Jet Nebuliser|Jet Nebuliser
15832940|NCT04181073|Device|Vibrating Mesh Nebuliser|Aerogen Device
15832943|NCT04181047|Behavioral|Eye Movement Desensitization and Reprocessing (EMDR)|Psychotherapy.
15832944|NCT04181047|Other|Usual care|Access to usual care, including psychiatrist, medications, mental health therapist, general community mental health programs. TAU will NOT include electroconvulsive therapy or another trauma specific psychotherapy.
15832945|NCT04181034|Behavioral|Adolescent Family Life Program Positive Youth Development (PYD) program|Home visiting program for pregnant and parenting teens with PYD component
15832946|NCT04181034|Behavioral|Adolescent Family Life Program (AFLP)|Home visiting program for pregnant and parenting teens
15832947|NCT04181021|Behavioral|Values Clarification and Attitudes Transformation (VCAT) Workshop|VCAT is a participatory workshop aimed to provide accurate information about abortion and family planning and space to engage in critical self-reflection, provoke dialogue on beliefs, values and professional ethics and responsibilities around providing abortion and contraceptive care, and provide a deeper understanding of the range of circumstances in which women seek abortion and contraception.
15832948|NCT04181008|Drug|Amiloride|Amiloride Nasal Spray
15832949|NCT04181008|Drug|Amiloride|Amiloride Nasal Spray
15832950|NCT04181008|Drug|Amiloride|Amiloride Nasal Spray
15832951|NCT04180995|Drug|TORIPALIMAB INJECTION(JS001 ) Axitinib tablet (Inlyta®)|TORIPALIMAB INJECTION(JS001 ) combined with chemotherapy, 3mg/kg, Q2W,up to 1 years of treatment.
15832952|NCT04180982|Drug|SHR4640 dose1 plus Febuxostat dose1|Tablet,dose1,QD
15832953|NCT04180982|Drug|SHR4640 dose1 plus Febuxostat dose2|Tablet,dose1, dose2 QD
15832954|NCT04180982|Drug|SHR4640 dose2 plus Febuxostat dose3|Tablet,dose2, dose3 QD
15832955|NCT04180969|Drug|yohimbine + hydrocortisone|yohimbine 54mg + hydrocortisone 20mg oral
15832956|NCT04180969|Device|medial prefrontal cortex rTMS|1 Hz mPFC rTMS
15832957|NCT04180969|Drug|Placebo oral tablet|placebo stressor
15832958|NCT04180969|Device|sham rTMS|sham mPFC rTMS
15832959|NCT04180956|Other|Bias-reduction Intervention|A training for doctors
15832960|NCT04180943|Drug|interscalene nerve block|intra and post-operative analgesia
15832961|NCT04180930|Diagnostic Test|CAPS-5|Clinician Administered PTSD Scale for DMS-5
15832962|NCT04180930|Diagnostic Test|PSSI-5|PTSD Symptom Scale Interview for DSM-5
15832963|NCT04180930|Diagnostic Test|CAPS-IV|Clinician Administered PTSD Scale for DSM-IV
15832964|NCT04180917|Other|Survey|survey
15832965|NCT04180904|Other|Diet 1|Diet 1 will focus on which foods are eaten and the impact on disease outcomes.
15832966|NCT04180904|Other|Diet 2|This diet will limit the amount of food energy consumed each day and the impact on disease outcomes. This will be determined by factors including the subject's demographics (age, sex, weight, height).
15832967|NCT04180878|Behavioral|Intervention|Participants received a interactive physical activity monitoring system that allowed study personnel to monitor their activity level.
15832968|NCT04180878|Behavioral|Intervention 2|Participants received an interactive physical activity monitoring system, an electronic scale to report weekly body weight, weekly hour long conference calls with structured interactive educational lessons led by Health Educator, dietary recalls were completed at three different time points during their participation, and study personnel monitored physical activity levels weekly.
15832969|NCT04180852|Other|Functional tests without clinical consequence for the patients therapy|Battery of tests, which measure the patients functional outcomes regarding their muscle mass, their muscle strength, fat mass, physical function, neuropsychological function and quality of life.
15832970|NCT04180839|Behavioral|gaming-related retrieval-extinction|"During one training session,participants will first view a 5-min retrieval video containing gaming content and then, 10 minutes later, receive 1-hour of extinction training in which they will be administered four sequences of video, picture and in vivo gaming cues.
~The whole training includes 2 training sessions. Participants will receive one training session once a day for two consectutive days."
15832971|NCT04180839|Behavioral|nongaming-related retrieval-extinction|"During one session,participants will first view a 5-min neutral video and then, 10 minutes later, receive 1-hour of extinction training in which they will be administered four sequences of video, picture and in vivo gaming cues.
~The whole procedure includes 2 sessions. Participants will receive one session once a day for two consectutive days."
15832972|NCT04180826|Other|Observational|"Initially, the patient will be placed in a strict supine position (at 0°) in his hospital bed, according to the usual care.
~In a second step, the patient will be verticalized (from 0° to 90°). Intracranial hemodynamics parameters in supine position and during verticalization will be continuously recorded by attaching the ATYS TCD-X® transcranial Doppler helmet attached with glasses.
~After 15 minutes of recording, the patient will be placed back in supine position. The end of the patient's participation in the study will correspond to the removal of the ATYS TCD-X® helmet."
15832973|NCT04180813|Drug|Linagliptin|drug
15832974|NCT04180813|Drug|Acarbose|drug
15832975|NCT04180800|Other|Lubben Social Network Scale - 6|One short oral interview to complete the Lubben Social Network Scale in auto-survey, translated in French. It contains 6 questions on 30 points, higher scores are associated with more social engagement, lower scores, specifically under 12/30, are associated with social isolation.
15832976|NCT04180787|Dietary Supplement|Beverage Consumption|Participants will consume either VPX Bang® Keto Coffee beverage or flavor-matched placebo beverage in each condition.
15832977|NCT04180774|Biological|Tag-7 gene modified inactivated tumor cells|Patients received GMV once in three weeks subcutaneously in three points in the paravertebral region. One dose consisted of 10 million transfected and inactivated tumor cells. No dose reduction was allowed.
15832978|NCT04180761|Drug|intraoperative hyperthermic intraperitoneal chemotherapy (HIPEC)|single dose application of hyperthermic intraperitoneal chemotherapy (HIPEC) at 42.5°C for 60 minutes after the gastrectomy
15832979|NCT04180748|Other|fluorescence imaging with 405nm light|Each group will have images taken with an Health Canada approved device to capture images under white light and 405nm fluorescence with an mCherry filter. These images will not be used for diagnostics and will be analyzed for features which correlate to identified microbes from 16S RNA analysis and traditional microbiological technique. Groups are self identified by participants in order to capture a diverse population.
15832980|NCT04180735|Procedure|Liver transplantation|Liver transplantation
15832981|NCT04180722|Device|aTouchAway™ platform|Participants will receive multi-component Virtual Transition Intervention. The four components of the intervention comprise: (1) routine virtual clinic visits scheduled at the same frequency as usual care; (2) virtual care plan and action plan for respiratory infection/deterioration and management of ventilator issues; (3) remote, weekly and monthly monitoring of ventilator and cough assist metrics, VAI symptoms, and oxygen saturations; and (4) as needed clinical consultations triggered by identification of abnormal parameters or requested by the VAI or family caregiver.
15832982|NCT04180709|Device|Sleepio|Sleepio is an online cognitive behavioural therapy (CBT) based intervention designed to treat insomnia, conducted is 6 sessions. The program is an automated media-rich web-based application that is driven dynamically by baseline, adherence, performance and progress data. At the beginning of each session The Prof conducts a progressive review with the participant exploring the diary data submitted the week prior that includes sleep status and pattern, as well as progress based on goals previously set by the participant. The information, support and advice are personally tailored based on underlying algorithms.
15832983|NCT04180696|Device|aCRT ON|CRT device with AdaptivCRT enabled
15832984|NCT04180696|Device|aCRT OFF|CRT device with AdaptivCRT disabled
15832985|NCT04180683|Other|Battery of screening tests with semi-structured interview|First, participants will be administered the Mini-Mental State Examination to assess if they meet the inclusion criteria and an ID will be assigned to the participants that meet the criteria. Posteriorly, a clinical psychologist will administer the GDS-30, GDS-15, GDS-10 and GDS-5, the BDI-II and a semi-structured interview about depressive disorders according to the DSM-5 criteria. Participants with even ID's from each institution will be answer the instruments according to the order GDS-30, GDS-10, BDI-II, GDS-5 e GDS-15 and participants with odd ID's will answer the battery in the reverse order. The assessment session will take place in a single moment in time. After the assessment, the clinical psychologist will answer a questionnaire about which version was more easily understandable by the participants and the participants' preference regarding the GDS versions.
15832986|NCT04180683|Other|Battery of screening tests without semi-structured interview|First, participants will be administered the Mini-Mental State Examination to assess if they meet the inclusion criteria an ID will be assigned to the participants that meet the criteria. Posteriorly, a psychologist will administer the GDS-30, GDS-15 and the BDI-II. Participants with even ID's from each institution will answer the instruments according to the order GDS-30, BDI-II and GDS-15 and participants with odd ID's the administration order will answer the battery in the reverse order. The assessment session will take place in a single moment in time.
15832987|NCT04180657|Genetic|Protein C deficiency|The effect of protein C deficiency on ghrelin levels are investigated.
15832988|NCT04180644|Other|Skin tape strips|Skin tape strips will be collected from lesional and non-lesional skin. Adhesive skin sampling discs will be firmly pressed against the skin in a hairless location (not the face) followed by lifting it free of the skin. These discs will then be used to evaluate proteins and lipids in the upper layers of skin.
15832989|NCT04180631|Diagnostic Test|Quantitative ultrasound imaging parameter (QUS)|Quantitative ultrasound imaging parameters (QUS) are analyzed to evaluate hepatic steatosis
15832990|NCT04180618|Other|Personal health wallet service for emergency situation|Patients(caregivers) and medical staffs will be provided the personal health wallet service and evaluate the effectiveness and satisfaction for the service.
15832991|NCT04180605|Other|Additional support for preoperative planning of LAA closure procedures|"The results of the computational simulations provided by FEops HEARTguideTM will be used in the computational simulation arm as an additional preoperative planning tool and their potential added value will be assessed by comparison to the standard of care arm."
15832992|NCT04180605|Procedure|Left atrial appendage closure|Transcatheter device insertion to exclude the LAA from the cardiac circulation
15832993|NCT04180592|Procedure|CT Fusion + Transrectal U/S Guided Prostate Biopsy|All patients will receive both a CT fusion biopsy and a standard TRUSP biopsy. They will be randomized to which is received first, followed by receipt of the alternative procedure.
15832994|NCT04180579|Device|PAXMAN Scalp Cooler|Scalp cooling will occur with each dose of chemotherapy.
15832995|NCT04180566|Other|Ultrasound Examination|Includes a regular growth ultrasound examination.
15832996|NCT04180566|Other|Antenatal Testing (biophysical profile)|Includes weekly ultrasounds with a biophysical profile, which measures fetal tone, fetal movements, fetal breathing and amount of amniotic fluid (water around baby).
15832997|NCT04180553|Diagnostic Test|Point of Care Ultrasound (POCUS)|The intervention group will receive a 4-view transthoracic echocardiogram including Parasternal long axis, parasternal short axis, apical 4-chamber, and supplemental subcostal short-axis/4-chamber views as needed. A standard 4-view thoracic lung ultrasound study will assess the left and right anterior chest wall, anterior axillary regions, as well as the costophrenic angle and posterolateral regions. At 5 discrete time intervals post-operatively, POCUS assessments will be used to adjust fluid resuscitation to fluid liberal (2cc/kg/hr) or fluid restrictive (0.8cc/kg/hr). Routine vital signs, biochemistry, and urine output as well as bedside physical exam will be assessed as usual. IV boluses of crystalloid will be permitted to treat hypotension with SBP <90mmHg with clinical signs of hypovolemia, but oliguria will not be used as a marker to titrate fluid infusion rates. Blood transfusion may be used for post-operative bleeding or anemia as clinically indicated.
15832998|NCT04180553|Other|Usual Care|"The control group for usual care will undergo resuscitation guided by modalities used currently, which can include both static and dynamic measures. These will include review of vital signs, biochemistry, and urine output as well as bedside physical exam. In this arm, patients will not undergo POCUS during their admission. IV fluid infusion rates as well as targets for IV boluses will be left to the discretion of the attending physician and can include hypotension, hypovolemia, as well as oliguria. Blood transfusion may be used for post-operative bleeding or anemia as clinically indicated."
15833061|NCT04180072|Drug|Atezolizumab|Atezolizumab 1200 mg IV on day 1 every 3 weeks
15832999|NCT04180540|Device|Percutaneous Closure|The PerClose Proglide system will be used to deliver a suture to close the venous puncture following completion of ablation for treatment of atrial fibrillation.
15833000|NCT04180540|Other|Manual Compression|"Manual compression is the standard method of attaining hemostasis following ablation for treatment of atrial fibrillation. Manual compression may be performed with or without figure of eight suture for hemostasis at the discretion of the treating physician)."
15833001|NCT04180514|Diagnostic Test|intradialytic hypotension episode|Intradialytic hypotension episode under regular hemodialysis
15833002|NCT04180501|Combination Product|SRS sequential sintilimab|The subjects first received a targeted radiotherapy of SRS, and started the treatment of sintilimab per 3 weeks within 35 days after SRS.
15833006|NCT04180475|Device|MedRem application|Medication adherence smartwatch application
15833011|NCT04180449|Other|Screening for dysphagia along clinical routine|Screening for dysphagia using the water swallow test in intermediate care unit patients
15833012|NCT04180436|Drug|rivaroxaban 20 mg once daily 8 days|Blood samples for the measurement of rivaroxaban PK parameters
15833013|NCT04180423|Device|Off-the-Shelf Implant Total Knee Replacement|Total Knee Replacement, or knee arthroplasty, is a common surgical procedure performed to relieve the pain and disability resulting from osteoarthritis. In general, the surgery consists of replacing the diseased or damaged joint surfaces of the knee with metal and plastic components shaped to allow continued motion of the knee. Off-the-Shelf implants use standard sizing.
15833014|NCT04180423|Device|Customized Implant Total Knee Replacement|Total Knee Replacement, or knee arthroplasty, is a common surgical procedure performed to relieve the pain and disability resulting from osteoarthritis. In general, the surgery consists of replacing the diseased or damaged joint surfaces of the knee with metal and plastic components shaped to allow continued motion of the knee. Customized implants are customized individually made knee implants which are designed specific to each patient's unique anatomy.
15833015|NCT04180410|Device|EIT|Electrical Impedance Tomography is performed before extubation, during follow-up visits of extubation and 48H after extubation. Follow-up visits are shortened in case of extubation failure.
15833016|NCT04180397|Drug|Furosemide|Furosemide 10 mg/ml for injection/infusion
15833017|NCT04180397|Drug|Isotonic saline|Isotonic saline used as placebo (injection/infusion)
15833018|NCT04180384|Drug|Oraxol|"Paclitaxel:
~5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13- ester with (2R,3S)-N-benzoyl-3-phenylisoserine
~HM30181 methanesulfonate monohydrate:
~N-(2-(2-(4-(2-(6,7-Dimethoxy-3,4-dihydroisoquinolin-2(1H)-yl)ethyl)phenyl)-2H-tetrazol-5-yl)-4,5-dimethoxyphenyl)-4-oxo-4H-chromene-2-carboxamide Methanesulfonate monohydrate"
15833019|NCT04180371|Drug|BT5528|Participants will receive a 60-minute intravenous infusion of BT5528 once a week (Days 1, 8, 15, and 22) or every other week (Days 1 and 15) on a 4-week cycle at the selected dose.
15833020|NCT04180371|Drug|Nivolumab|Participants will receive nivolumab at 480mg intravenous infusion every 4 weeks.
15833021|NCT04180358|Behavioral|Native STAND|Native STAND is a comprehensive sexual health curriculum for Native high school students that focuses on sexually transmitted infections, HIV/AIDS, and teen pregnancy prevention, while also covering drug and alcohol use, suicide, and dating violence. Twenty-seven sessions support healthy decision-making through interactive discussions and activities that promote diversity, self-esteem, goals and values, team building, negotiation and refusal skills, and effective communication. Sessions will be conducted in regular Physical Education and/or Health Education classes during classroom/school hours.
15833022|NCT04180358|Behavioral|Regular Health/Physical Education Curriculum|General health and physical education curriculum provided by New Mexico's Public Education Department.
15833023|NCT04180345|Other|Psychometric validation of the questionnaire|"Delph Process : expert panel will include HCPs and patients. They will evaluate the relevance of items on a Likert scale (HCPs N = 25 ; Patients N = 25 ) Think aloud interviews (N = 10 patients) Psychometric validation ( N = 200 patients)"
15833024|NCT04180332|Diagnostic Test|Blood sample|5ml of venous blood was taken from the ante cubital vein from each of the study subjects
15833025|NCT04180306|Other|pediatric early warning scoring system and resuscitation curriculum|teaching resuscitation to medical providers and implementing a scoring tool to help identify patients at risk for clinical deterioration in an inpatient setting
15833026|NCT04180293|Behavioral|Pilot psychoeducation program|Canadian Armed Forces veterans and their family members will be recruited to participate in this pilot virtual psychoeducation program and its evaluation. Two six-week sessions will be implemented over a virtual care platform (Zoom for healthcare) based out of OSI Clinic in Atlantic Canada - the first in January/February of 2021 and the second in the spring of 2021. A maximum of 10-15 participants (including both veterans and their family members) will be recruited for each group. Family members are defined as spouses/partners, siblings, parents, and adult children. Each of the weekly sessions will take place virtually and will be led by at least two trained facilitators (one from the research team, and one member of the OSI clinical staff team). Each of these sessions will focus on providing education of different topics relevant to those accessing services at the clinic (e.g., types of treatments available, tools to support families, self care, etc.).
15833027|NCT04180293|Other|Program evaluation|At the end of each six-week session, program outcomes will be assessed qualitatively by a member of the research team. Participants will take part in semi-structured interviews guided by questions informed by the ecological family systems theory.
15833028|NCT04180280|Behavioral|Behavioral self-regulation Phone counseling to improve HIV care|Participants receive 5 sessions of behavioral counseling to improve HIV care. Counseling is delivered using phone calls by a trained adherence and care engagement counselor.
15833029|NCT04180280|Behavioral|Behavioral self-regulation Office counseling to improve HIV care|Participants receive 5 sessions of behavioral counseling to improve HIV care. Counseling is delivered in clinical care offices s by a trained adherence and care
15833030|NCT04180267|Device|Low-magnitude High-frequency Vibration|35Hz, 0.3g, 20min/day, at least 3 times/week
15833031|NCT04180254|Procedure|Effect of several processing on the auditory distance perception|The focus is a comparison of hearing instrument algorithms on the auditory distance perception
15833032|NCT04180241|Procedure|POEM|Peroral endoscopic myotomy
15833033|NCT04180228|Other|self-administred questionnaire|On the occasion of a follow-up consultation with referent pediatrician, a self-administred questionnaire is distributed. It will take around ten minutes to the patient and her parents for completing the questionnaire. Questionnaire is anonymous. Participation is free and informed by an information notice. There is a list of items to complete by the patient and her parents. Most of questions are closed-ended. Clinical data are reported : age, level of education, principal disease (SLE or Juvenile arthritis), received treatments. In the questionnaire, it is asked if the patient is vaccinated or not for HPV, and reasons for it.
15833034|NCT04180215|Drug|HB-201 intravenous administration.|Dose / Schedule determined by 3+3 dose escalation (3 to 6 patients per cohort).
15833035|NCT04180215|Drug|HB-201 intratumoral administration for first dose, followed by HB-201 intravenous administration for subsequent doses.|Dose / Schedule determined by 3+3 dose escalation (3 to 6 patients per cohort)
15833036|NCT04180215|Drug|HB-202 intravenous administration alternating with HB-201 intravenous administration.|Dose / Schedule determined by 3+3 dose escalation (3 to 6 patients per cohort).
15833037|NCT04180215|Drug|HB-201 intratumoral administration for first dose; followed by HB-202 intravenous administration alternating with HB-201 intravenous administration for subsequent doses.|Dose / Schedule determined by 3+3 dose escalation (3 to 6 patients per cohort)
15833038|NCT04180215|Drug|HB-201 intravenous administration at recommended phase II dose and determined schedule.|Dose Expansion
15833039|NCT04180215|Drug|HB-201 intravenous administration at recommended phase II dose and determined schedule + immune checkpoint inhibitor per standard of care.|Dose Expansion
15833040|NCT04180215|Drug|HB-201 intratumoral administration for first dose followed by HB-201 intravenous administration for subsequent doses at recommended phase II dose and determined schedule.|Dose Expansion
15833041|NCT04180215|Drug|HB-202 intravenous administration alternating with HB-201 intravenous administration at recommended phase II doses and determined schedule.|Dose Expansion
15833042|NCT04180215|Drug|HB-201 intratumoral administration for first dose; followed by HB-202 intravenous administration alternating with HB-201 intravenous administration for subsequent doses at recommended phase II dose.|Dose Expansion
15833043|NCT04180215|Drug|HB-202 intravenous administration alternating with HB-201 intravenous administration at recommended phase II doses and determined schedule + immune checkpoint inhibitor.|Dose Expansion
15833044|NCT04180215|Drug|HB-201 intravenous administration for a limited number of dose administration.|Dose/Schedule determined by 3+3 dose escalation (3 to 6 patients per cohort)
15833045|NCT04180215|Drug|HB-202 intravenous administration alternating with HB-201 intravenous administration for a limited number of dose administration|Dose/Schedule determined by 3+3 dose escalation
15833046|NCT04180215|Drug|HB-201 or HB-201/HB-202 alternating treatment using CD8 PET Tracer (Zr-Df-IAB22M2C)|Dose escalation; 10 patients
15833047|NCT04180202|Device|Non-invasive central venous pressure|Non-invasive method to measure central venous pressure indicator
15833048|NCT04180189|Other|Weighted fiber blanket|Using weighted blanket for four weeks
15833049|NCT04180176|Other|Blood Draw|Participants will have blood drawn at enrollment, the first tumor assessment, and at disease progression or end of therapy.
15833050|NCT04180163|Drug|Lanadelumab|Participants receive 300 mg of lanadelumab solution q2w (treatment period A) for 26 weeks and q2w or q4w (treatment period B) for 26 weeks, for overall 52 weeks of treatment period.
15833051|NCT04180150|Drug|TQ-A3334|TQ-A3334 is a kind of TLR7 receptor agonist.
15833052|NCT04180150|Drug|Placebo|Placebo is a treatment which is designed to have no therapeutic value.
15833053|NCT04180150|Drug|Entecavir Tablet|Entecavir (ETV) tablet is an antiviral medication used in the treatment of hepatitis B virus (HBV) infection.
15833054|NCT04180137|Procedure|Endovenous laser ablation of great saphenous vein (GSV) and microphlebectomy of varicose veins|"Surgical treatment is performed as endovenous laser ablation of GSV and microphlebectomy of varicose branches according to a standard protocol:
~The intervention includes treatment of the pathological upright reflux and varicose veins. Ultrasound-guided GSV puncture at the upper third of the leg under local anesthesia. The light guide is inserted into the vein lumen and pushed through to the saphenofemoral junction. Under ultrasound guidance the light guide is positioned at v. epigastrica superficialis junction. Under ultrasound guidance tumescent anesthesia is produced around the GSV from puncture site up to the saphenofemoral junction. Laser coagulation (with radial light guide), linear energy density - 75 J/cm, automatic traction of the light guide at the speed 0.7 mm/sec. Varicose veins are resected through skin punctures using Varady hook 1-2 mm."
15833055|NCT04180137|Drug|Pharmacotherapy|After surgical intervention the active treatment group will receive sulodexide 250 lipasemic units (LSU) bid for 30 days.
15833056|NCT04180124|Other|Walking|"Patients walk over ground on a mat with sensors and on a treadmill with sensors (in different conditions) to compare their movement pattern.
~Also the movement pattern will be compared between walking at comfortable walking speed en fast walking.
~Finally, the correlation between upper extremity impairment and arm swing will be investigated."
15833057|NCT04180111|Device|CATS Tonometer|CATS Tonometer Prism
15833058|NCT04180098|Behavioral|C-mill intervention|A five week personalised rehabilitation program. Participants train gait adaptability via obstacle negotiation, precision stepping and unexpected accelerations and decelerations. The strategies are trained in a safe environment on the C-mill, a treadmill providing augmented reality via visual and acoustic cues. The treatment is implemented in a five week period via 10 biweekly sessions. Each treatment session lasts 60 minutes. In total, participants will receive C-mill training for a total of ten hours. The training will be carried out by a skilled physiotherapist.
15833063|NCT04180059|Combination Product|CTL 19|Patients candidate for allogeneic transplantation who are both HLA-DPB1*04:01 and with a HLA-DPB1*04:01-expressing hematological malignancy (almost 100% of cases) with a donor HLA-DPB1*04:01 negative, will be proposed to receive one single infusion of the T cell clone at 4-5 months post-transplantation, once the immunosuppression by cyclosporine and/or mycophenolate mofetil has been discontinued.
15833064|NCT04180033|Diagnostic Test|Colonoscopy surveillance|Participants will be asked to undergo a first colonoscopy surveillance.
15833065|NCT04180020|Other|ID/LAB|ID/LAB is the new model in which OUD is managed by Infectious Disease (ID) specialists and/or Hospitalists concurrent with management of the infectious diseases, using long-acting injectable buprenorphine (LAB).
15833066|NCT04180020|Other|TAU|TAU is designed to systematize what is the current practice at the participating hospitals and in most U.S. hospitals while offering a minimum standard of care. TAU will constitute recommendation for MOUD initiation and consultation for addiction medicine when available; in practice, it is typically detoxification from opioids and referral to community-based addiction treatment after hospital discharge.
15833067|NCT04180007|Drug|Apatinib|500 mg Apatinib given orally once a day for 12 wk prior to RAI (131I) treatment.
15833068|NCT04179994|Other|Miswak extract-containing toothpaste|Miswak extract-containing toothpaste will be applied to the tooth diagnosed with DH
15833069|NCT04179994|Other|Potassium nitrates-containing toothpaste|Potassium nitrates-containing toothpaste will be applied to the tooth diagnosed with DH
15833070|NCT04179994|Other|Placebo|A toothpaste containing the same ingredients of the test toothpaste except for the active ingredient
15833071|NCT04179981|Device|Positive airway pressure|Positive airway pressure therapy. OVS patients randomized to PAP therapy arm will be titrated to optimal PAP therapy per standard protocol and assigned to use PAP therapy.
15833072|NCT04179981|Other|Conservative care (control arm)|Eligible OVS patients will receive conservative care/usual care with education about sleep apnea and sleep hygiene via handouts and video instructions. This is the control arm.
15833073|NCT04179968|Drug|68Ga PSMA-11 injection|Injection of 68Ga PSMA-11
15833074|NCT04179968|Procedure|Positron Emission Tomography/Computed Tomography|PET/CT scan after 68Ga PSMA-11 injection
15833075|NCT04179942|Diagnostic Test|Fractional exhaled nitric oxide and CRP levels|measurement of FeNO and Hs-CRP after 3months of CPAP
15833076|NCT04179929|Drug|Pediatric-type of chemotherapy|Pediatric type chemotherapy (induction, early and delayed consolidation, reinduction, maintenance). Induction (VCR,PDN,PegASP,DNR). Early and delayed consolidation (high-dose Methotrexate, high-dose Cytarabine, PegASP). Reinduction (VCR, PDN, PegASP, DNR). Maintenance (Methotrexate, Mercaptopurine)
15833077|NCT04179929|Procedure|allogeneic HSCT|allogeneic HSCT
15833078|NCT04179916|Diagnostic Test|stimulation in virtual reality|"HTC VIVE pro was used to stimulate patients in virtual reality. The glasses enable high resolution and high fluidity (90Hz) images to be displayed. The display used inside the glasses, OLED class, allows for accurate color replication. Numerous sensors placed in the glasses (such as gyroscope, accelerometer, magnetometer) supported by dedicated processors processing data from the sensors, instantly transfer the movement of the head of the rehabilitated person to virtual reality. Such a set allows to achieve full immersion in the virtual world. Various scenarios will be presented during the stimulation, such as beach, snow landscape, darkened room, rollercoaster ride.
~It was planned to submit 3 scenarios with a total stimulation time of up to 20 minutes."
15833079|NCT04179903|Other|Physical activity|Physical Activity program is performed in a group in a gym and at home
15833080|NCT04179890|Drug|Epidermal Growth Factor Tyrosine Kinase Inhibitor|Up to 30 months
15833081|NCT04179890|Drug|Afatinib|Up to 30 months
15833082|NCT04179877|Behavioral|IPS|Occupational rehabilitation and support Integrated with clinical treatment
15833083|NCT04179864|Drug|Tazemetostat|Tazemetostat (EPZ-6438) is a selective small-molecule inhibitor of the histone-lysine methyltransferase EZH2 gene
15833084|NCT04179864|Drug|Abiraterone/prednisone|1,000 mg (two 500 mg tablets or four 250 mg tablets) orally once daily in combination with prednisone 5 mg administered orally twice daily.
15833085|NCT04179864|Drug|Enzalutamide|enzalutamide 160 mg (four 40 mg capsules) orally once daily
15833086|NCT04179851|Diagnostic Test|Thermal imaging of neck veins|Thermal imaging of neck veins
15833087|NCT04179838|Behavioral|Sleep-Deprived|Sleep for 4 hours at home.
15833088|NCT04179838|Behavioral|Non-Sleep Deprived|Sleep for 8 hours at home.
15833089|NCT04179799|Device|Diaphragm Pacing|"Intramuscular stimulation of the diaphragm, or diaphragm pacing' is achieved by laparoscopic placement of stimulation wires into each hemidiaphragm. Phrenic motor points on the diaphragm are mapped to optimize electrode placement. The electrodes are threaded into the diaphragm muscle and wire leads are externalized and attached to a stimulation controller."
15833090|NCT04179786|Biological|Sci-B-Vac™|Sci-B-Vac™ is a recombinant Hepatitis B vaccine, produced by SciVac Israel Ltd under good manufacturing practices (GMP). It contains the 3 surface antigens of the Hepatitis B virus: HBs, pre-S1 and pre-S2. Each 1 ml dose contains sterile 10 μg Hepatitis B virus surface antigens. It is formulated for intramuscular injection supplied in single use vials containing 1ml suspension.
15833091|NCT04179773|Other|Current care study|"Observational study in two parts:
~Cross-sectional study of patients with digestive or ENT cancer with indication for conventional chemotherapy treatment according to management guidelines, the objective of which is to determine the frequency of cirrhosis.
~Exposed/non-exposed cohort study of patients receiving a first course of conventional chemotherapy initiated in outpatient oncology clinic. (safety population).
~Exposed subjects will be patients with cirrhosis, included consecutively. Non-exposed subjects will be non-cirrhotic patients. They will be selected non-consecutively according to the following criteria, for matching to exposed subjects: age (±5 years), type of cancer (digestive vs. ENT), treatment stage (curative vs. palliative). Two unexposed subjects will be selected for 1 exposed subject."
15833092|NCT04179760|Biological|SCM-AGH|SCM-AGH will be administrated 3 times with 2-week intervals by IV infusion to subjects at Weeks 0, 2 and 4 (Visits 2, 3 and 4).
15833093|NCT04179760|Other|Placebo|Placebo will be administrated 3 times with 2-week intervals by IV infusion to subjects at Weeks 0, 2 and 4 (Visits 2, 3 and 4).
15833094|NCT04179747|Behavioral|Cognitive Behavioral Psychotherapy|The Cognitive Behavior Psychotherapy was provided for a period of maximum 3 months.
15833507|NCT04176549|Other|Elective management of gynaecology patients|Elective hysterectomy and salpingo-oophorectomy
15833095|NCT04179747|Drug|Sildenafil Citrate 50Mg Tab|The participants in control group arm received Sildenafil Citrate 50mg tablet on demand for a period of maximum 3 months.
15833096|NCT04179734|Drug|Bremelanotide|Melanocortin-4 receptor agonist subcutaneous injection.
15833097|NCT04179734|Drug|Placebo|Placebo subcutaenous injection.
15833098|NCT04179721|Behavioral|PES-4-BPSD Model|"Staff Training: Dementia Care Education and Training. The PI, with the support of the research team, will spend 12 weeks training the PES/NA staff. Based on the Try This: Best Practices in Nursing Care for Persons with Dementia, the PES staff will receive weekly 20 minute sessions. This study aims to capture the impact of dementia care training on the experience of PES (intervention unit) and NA (control unit) staff to care for patients with dementia. Measures will be completed at baseline, prior to dementia training (T1: baseline), immediately after completion of the training program (T2: 3 months post-baseline) and following the completion of the 1-year intervention period (T3: 12 months post-training)."
15833099|NCT04179721|Behavioral|The attention control condition|"Staff Training: Dementia Care Education and Training. The PI, with the support of the research team, will spend 12 weeks to train the PES/NA staff. Based on the Try This: Best Practices in Nursing Care for Persons with Dementia, the PES staff will receive weekly 20 minute sessions. This study aims to capture the impact of dementia care training on the experience of PES (intervention unit) and NA (control unit) staff to care for patients with dementia. Measures will be completed at baseline, prior to dementia training (T1: baseline), immediately after completion of the training program (T2: 3 months post-baseline) and following the completion of the 1-year intervention period (T3: 12 months post-training)."
15833100|NCT04179708|Other|Pain Neuroscience Education|"Intervention description Patients participate in a back school program including initial and final assessment, educational activities and therapeutic activities (eg. Physiotherapy, balneotherapy, physical activity, spine ergonomics, and so on) spread over 5 days. The therapeutic activities are the same in experimental and control group, only the educational activities differ.
~The educational activities represent 4 hours of intervention, ½ hours of educative initial assessment and ½ hour of educative final assessment.
~The content of Pain Neuroscience Education (experimental group) focuses on deconstruction of patho-anatomical and biomechanical believes, and the explanation of pain from the biology. This framework allows the introduction of coping strategies (eg gradual exposure to exercise, activity and physical activity) and regulation strategy (eg fragmentation of activity, stress management, and so on)."
15833101|NCT04179708|Other|Conventional education|"assessment, educational activities and therapeutic activities (eg. Physiotherapy, balneotherapy, physical activity, spine ergonomics, and so on) spread over 5 days. The therapeutic activities are the same in experimental and control group, only the educational activities differ.
~The educational activities represent 4 hours of intervention, ½ hour of educative initial assessment and ½ hour of educative final assessment.
~The content of conventional education (control grou) focuses on patho-anatomical and biomechanical notions. This framework allows the introduction of protection strategies (eg education on good posture, good handling techniques, physical activity and therapeutic exercise in stretch and strenghten the spine in order to protect it)."
15833102|NCT04179695|Other|Consulting with PARKINSUN as communication aid-tool|Participating patients visit their general practitioner or neurologist with PARKINSUN at 1 months, 4 months, 7 months
15833103|NCT04179695|Other|Consulting without PARKINSUN as communication aid-tool|Participating patients visit their general practitioner or neurologist without PARKINSUN at 1 months, 4 months, 7 months
15833104|NCT04179682|Procedure|40-hour constraint-induced movement therapy|Participants were randomly allocated to 1 of 2 CIMT programs (40 hours): a 2-week 4-hours/day CIMT program and a 4-week 2-hours/day CIMT program. One CIMT program was performed 1 month after a BoNT-A injection, and then the second program was implemented with the next injection.
15833105|NCT04179669|Drug|IBI306|Administered by subcutaneous injection
15833106|NCT04179669|Drug|placebo|Administered by subcutaneous injection
15833107|NCT04179656|Drug|Pyrotinib|400 mg administered orally, once daily, continuously in 21 day cycles
15833108|NCT04179643|Biological|3 x 10e13vg NAN-101|There are 2 components to NAN-101. The first is an active I-1 transgene (AA 1-65 with T35D), and the second is the vector, BNP116, which delivers the gene selectively to the heart after intracoronary administration.
15833109|NCT04179630|Biological|Aldafermin (NGM282)|Single 3 mg dose
15833110|NCT04179617|Other|5% nicotine content JUUL pod|JUUL pods that contain 5% nicotine
15833111|NCT04179617|Other|3% nicotine content JUUL pod|JUUL pods that contain 3% nicotine
15833112|NCT04179604|Drug|Levosimendan|Levosimendan SIMDAX 2.5 mg / ml concentrate for solution for infusion. The concentrate is a clear solution, yellow or orange, for dilution before administration. A 5 ml vial contains 12.5 mg of levosimendan. The study drug infusion will start one day before surgery in an Intensive Care Unit with at least 8 hours of administration before surgery. A continuous infusion at 0.1 µg/kg/min will be administered to complete 24h duration.
15833113|NCT04179604|Drug|Placebos|Patients in the placebo group will receive a water-soluble vitamin B2 concentrate with 0.4 mg / ml sodium riboflavin phosphate to obtain the same color as the preparation of levosimendan and ethanol anhydrous 100 mg / ml to resemble the levosimendan odor, which will be administered at the same levosimendan infusion rate.
15833114|NCT04179591|Other|Exercise|Intrinsic foot muscles and tibialis posterior strengthening exercises
15833115|NCT04179591|Other|Orthesis|Customized arch support insoles
15833116|NCT04179578|Procedure|Crura plastic|Closure of hiatus with a running suture
15833117|NCT04179565|Behavioral|Healthy Children Healthy Families|The Healthy Children, Healthy Families: Parents Making a Difference! intervention was developed by the investigators for low-income parents and caregivers focusing on the behaviors most likely to help children avoid unhealthy weight gain.
15833118|NCT04179552|Device|PAAG-OA|Intra-articular injection with PAAG-OA (polyacrylamide hydrogel)
15833119|NCT04179539|Diagnostic Test|V/Q PET/CT|Ventilation images are acquired after inhalation of Galligas prepared using a Technegas generator (Cyclopharm, Sydney, Australia). The patients is placed in a supine position and inhaled Galligas using the standard ventilation technique. Ventilation images are then acquired. Without the patient moving, 68Ga-MAA are then injected. Perfusion PET images are then acquired
15833120|NCT04179539|Diagnostic Test|CTPA|CTPA will be done according to the usual protocol in the radiology department of the investigator center
15833508|NCT04176536|Drug|BI 764198|Capsules
15833509|NCT04176523|Drug|Carglumic Acid|Maintenance therapy with carglumic acid
15833121|NCT04179526|Behavioral|Transdiagnostic Internet-delivered REBT|The protocol is based on Rational Emotive and Behavioral Therapy (REBT; Ellis, 1962, 1994). The program will consist of 8 modules, delivered online over six weeks.
15833122|NCT04179513|Biological|GB224 10mg|"10 mg, 12subjects, abdominal subcutaneous injection, the next dose group can be initiated only after the safety and tolerability are confirmed within 4 weeks after the second dosing is given.
~Dosage and administration at enrollment are maintained (10~15 mg/week), oral administration, a total of 32 doses."
15833123|NCT04179513|Biological|GB224 20mg|"20 mg, 12subjects, abdominal subcutaneous injection, the next dose group can be initiated only after the safety and tolerability are confirmed within 4 weeks after the second dosing is given.
~Dosage and administration at enrollment are maintained (10~15 mg/week), oral administration, a total of 32 doses."
15833124|NCT04179500|Drug|Pretomanid|pretomanid 200 mg (once daily) for 26 weeks (with meal)
15833125|NCT04179500|Drug|Bedaquiline|bedaquiline 200 mg (once daily) for 8 weeks (with meal), then bedaquiline 100mg (once daily) for 18 weeks (with meal)
15833126|NCT04179500|Drug|moxifloxacin|moxifloxacin 400 mg (once daily) for 26 weeks (with meal)
15833127|NCT04179500|Drug|pyrazinamide|pyrazinamide 1500 mg (once daily) for 26 weeks (with meal)
15833128|NCT04179487|Diagnostic Test|OPTICA CTPA Protocol|Low dose CT pulmonary angiogram protocol
15833129|NCT04179474|Drug|Ubrogepant|Oral administration of 100 mg ubrogepant tablet once daily [Intervention A=single dose and Intervention D=repeated daily dose].
15833130|NCT04179474|Drug|Erenumab|Single dose subcutaneous (SC) injection of erenumab 140 mg [Intervention B].
15833131|NCT04179474|Drug|Galcanezumab|2 SC injections of galcanezumab 120 mg [Intervention C].
15833132|NCT04179461|Drug|Cholecalciferol|Oral administration
15833133|NCT04179461|Drug|antihistamine|Oral administration
15833134|NCT04179461|Drug|Azithromycin|Oral administration
15833135|NCT04179461|Drug|emollient cream|Topical
15833136|NCT04179461|Drug|Fluticasone Propionate|Nasal spray
15833137|NCT04179461|Drug|Asthma Controller Medication|Study participants asthma controller medication may be increased based off of their asthma control and the recommendation of the personalized plan.
15833138|NCT04179448|Procedure|SAMRI|Side Access Mucosal Releasing Incision (SAMRI) will be performed on all individuals in this arm of the study to facilitate coronal advancement of the gingival flap and placement of acellular dermal matrix
15833139|NCT04179448|Procedure|STA|Sulcular tunnel access incision will be performed on all individuals in this arm of the study to facilitate coronal advancement of the gingival flap and placement of acellular dermal matrix
15833140|NCT04179435|Behavioral|Behavioral testing on cognitive computerized tasks|Testing on cognitive computerized tasks
15833141|NCT04179435|Other|brain MRI|Brain MRI scans
15833142|NCT04179435|Other|TMS|Measure of the cortical inhibitory capacity using TMS measures
15833143|NCT04179422|Other|anthropometric measurement|weight, height, BMI
15833144|NCT04179422|Other|nutritional questionnaire|24hs food recall, presence of feeding disorders
15833145|NCT04179409|Drug|Casimersen|This drug is used to target skipping of exon 45 of the dystrophin gene.
15833146|NCT04179409|Drug|Eteplirsen|This drug is used to target skipping of exon 51 of the dystrophin gene.
15833147|NCT04179409|Drug|Golodirsen|This drug is used to target skipping of exon 53 of the dystrophin gene.
15833148|NCT04179396|Drug|Rucaparib|Oral rucaparib will be administered twice daily
15833149|NCT04179396|Drug|Enzalutamide|"Enzalutamide will be administered once daily.
~Enrollment into Arm A will be prioritized over Arm B until the objectives for Arm A have been achieved."
15833150|NCT04179396|Drug|Abiraterone|Abiraterone will be administered once daily with prednisone
15833151|NCT04179383|Other|Constitution of a biobank|"We are collecting additional blood and CSF samples for patients (during RCVS episode and after resolution of RCVS episode) and for control subjects to constitute a biobank, in order to compare different biologic parameters between RCVS patients and healthy volunteers. A specific agreement will be asked to patients and control subjects before collection of samples.
~This is why this study is classified as 'interventional' rather than 'observational'."
15833152|NCT04179370|Other|N/A - no intervention. Observational study.|N/A - no intervention. Observational study.
15833153|NCT04179344|Other|Integrated e-healthcare services (IeHS) web-based app|Each participant is asked to complete study tasks using the IeHS web-based app as a part of IeHS simulation. This activity is followed by user experience survey, and an in-depth interview to explore user satisfaction on the IeHS web-based app
15833154|NCT04179331|Other|Neurotensin|Neurotensin is an endogenous peptide released from the distal small intestine. It will be administered at three doses (2.5, 5.0 and 7.5pmol/kg/min), each for 1h, in sequence.
15833155|NCT04179331|Other|Saline|Isotonic saline will serve as a placebo.
15833156|NCT04179318|Diagnostic Test|Geneswell BCT|Geneswell BCT is a precise and qualitative in vitro diagnostic test. The expression of 9 genes was obtained from the formalin fixed paraffin embedded block (FFPE) of breast cancer tissue samples by RT-qPCR, and the patients were divided into high-risk group and low-risk group.
15833157|NCT04179305|Behavioral|Oncolo-GIST|"Behavioral: Oncolo-GIST Oncolo-GIST is a brief, manualized communication intervention that guides oncologists in gist communication by itemizing 4 key steps in the process of imparting prognostic information.
~Topic covered include:
~Principles of introducing prognosis in the setting of worsened scan results Coupling communicating realistic prognoses with psychological support (e.g., saying average life-expectancy is months… with emphasizing that the oncology team will always provide care for you) Addressing informational needs and psychological reactions Applying proven techniques for supporting patients who are reluctant to discuss prognosis.
~The 4-step guide will include brief video-clips of demonstrating each talking point with a standardized patient, including ideal scenarios, common pitfalls to avoid, and how to respond to patient reactions that are particularly challenging, such as responding to optimism, death anxiety, and reliance on faith."
15833158|NCT04179305|Behavioral|Usual Care Arm|Oncologists will provide care in non-specific manner.
15833197|NCT04178941|Behavioral|Educational outreach|Educational outreach includes staff-targeted educational materials and outreach sessions summarizing the current evidence and guideline recommendations for continuous pulse oximetry use in bronchiolitis.
15833198|NCT04178928|Drug|Levothyroxine|investigate the effect of replacement therapy with levothyroxine on cardiovascular risk factors in children with SCH.
15833159|NCT04179292|Other|Hand Therapy by Physiotherapist|"stretching exercises; all finger joints, wrist and supination-pronation direction strengthening exercises; finger and wrist functional exercises retrograde massage; starting from the distal phalanx to the elbow sensory education; desentilation training (cotton…) breathing exercises 5 days / week, 8 weeks in total
~3 days / week with physiotherapist
~2 days / week as home program 30 minutes / day 12 repetitions"
15833160|NCT04179292|Other|Hand Therapy as home program|"stretching exercises; all finger joints, wrist and supination-pronation direction strengthening exercises; finger and wrist functional exercises retrograde massage; starting from the distal phalanx to the elbow sensory education; desentilation training (cotton…) breathing exercises 5 days / week, 8 weeks in total
~3 days / week with physiotherapist
~2 days / week as home program 30 minutes / day 12 repetitions"
15833161|NCT04179279|Device|Gili Biosensor System (Gili Pro Biosensor)|Non-contact monitoring of heart and respiratory rates using an optical device
15833162|NCT04179266|Drug|Ketamine|One Cluster headache attack is treated with intranasal ketamine
15833163|NCT04179253|Diagnostic Test|office micro hysteroscopy|One hundred women with unexplained infertility recruited for office micro hysteroscopic sessions. A rigid fiberoptic 2-mm, 0 and 30 degrees angled hysteroscopy along with an operative channel for grasping forceps or scissors were used for both diagnostic and operative indications. The findings, complications, and patient tolerance were recorded.
15833164|NCT04179240|Other|audio and animated cartoon questionnaire|participants were asked to complete a questionnaire audio and animated cartoon on a platform
15833165|NCT04179227|Other|Questionnaire Administration|Ancillary studies
15833166|NCT04179227|Other|Survey Administration|Ancillary studies
15833167|NCT04179214|Other|Thoracic manipulation|Session will be performed twice a week for a three week period if a pop sound occurred then the therapist moved on next procedure ,if not subject will be repositioned and technique will performed again. This procedure will be performed for maximum of two attempts. Approximately 3 minutes of time is required to complete thrust manipulation subjects assigned to thrust manipulation also received general exercise program and manual pressure release technique as the control group. General exercise group involve Stretching exercises for the pectoral muscles and resisted strengthening exercises for the scapular retractors and elevators and the glenohumeral abductors and external rotators were performed three times per week for 3 weeks.
15833168|NCT04179214|Other|conventional pt protocol|This group will receive manual pressure release technique along with general exercises program. General exercise group involve Stretching exercises for the pectoral muscles and resisted strengthening exercises for the scapular retractors and elevators and the glenohumeral abductors and external rotators were performed three times per week for 3 weeks.
15833169|NCT04179188|Procedure|Bariatric surgery|Classical Bariatric surgery (ring, Sleeve gastrectomy or Bypass)
15833170|NCT04179175|Drug|secukinumab|secukinumab 300mg every 2 or every 4 weeks
15833171|NCT04179162|Drug|Bacillus Calmette-Guérin (BCG)|Patients will receive once-weekly intravesical BCG therapy (TICE strain, 50 mg) at weeks 2 (+/- 2 days), 3 (+/- 2 days), 5 (+/- 2 days), 6(+/- 2 days), 8 (+/- 2 days), and 9 (+/- 2 days).
15833172|NCT04179162|Drug|Gemcitabine|Patients will receive gemcitabine at their specified dose level, given in a twice weekly fashion, with 72 to 96 h (+/- 1 day) between doses, at weeks 1, 4, 7, and 10.
15833173|NCT04179149|Behavioral|Environmental enrichment|The experimental group will participate in six modules that mimic and integrate the three hallmarks of EE: social interaction (more animals per cage = support group meetings, online support), novelty (toys and activities = exposure to new hands-on activities), and larger enclosures (larger cages = meetings in open environments). There will be 2 interventions per month, for three months, and a follow up 3 months after the end of the intervention
15833174|NCT04179136|Dietary Supplement|lignan capsules contain 300 mg flaxseed (SDG) extract|lignan capsules contain 300 mg flaxseed (SDG) extract
15833175|NCT04179136|Dietary Supplement|Placebo treatment matching intervention|Placebo treatment matching intervention
15833176|NCT04179123|Device|Customised PAP interfaces|Customised PAP interfaces
15833177|NCT04179110|Drug|Pembrolizumab and Ramucirumab|Patients will receive Pembrolizumab 200 mg & Ramucirumab 10 mg/kg every 3 weeks.
15833178|NCT04179097|Diagnostic Test|Finger photoplethysmography|Bilateral finger photoplethysmogray, bilateral brachial artery Doppler, Aorta artery Doppler
15833179|NCT04179084|Drug|fruquintinib|5mg qd, 2weeks on, 1week off
15833180|NCT04179084|Drug|Sintilimab|200mg q3w
15833181|NCT04179071|Drug|Savolitinib|Subject will receive savolitinib tablet 600mg orally after a high-fat, high-calorie meal.
15833182|NCT04179071|Drug|Famotidine|Subjects will receive famotidine tablet 40mg orally after an overnight (minimum 8hours) of fasting.
15833183|NCT04179058|Other|Follow-up|Clinical data, radiological data and laboratory tests follow-up
15833184|NCT04179045|Device|The Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent System|Subjects enrolled will be treated with Bioheart Rapamycin Drug-Eluting Bioresorbable Coronary Stent.
15833185|NCT04179032|Combination Product|Belimumab|Belimumab 200 mg/mL will be administered as SC injection in left or right thigh and the abdomen.
15833186|NCT04179019|Drug|Amlodipine|Amlodipine (10mg daily, as tolerated by blood pressure parameters) for 2 weeks
15833187|NCT04179006|Dietary Supplement|LF/Erinacine A-enriched Hericium/Plain chocolate + antidepressant(s)|3 pieces per day
15833188|NCT04178993|Drug|Methamphetamine|In each arm, subjects will receive doses of methamphetamine.
15833189|NCT04178993|Drug|Methylphenidate|In each arm, subjects will receive methylphenidate capsules.
15833190|NCT04178993|Drug|Placebo oral capsule|In each arm, subjects will receive placebo capsules.
15833191|NCT04178993|Drug|Duloxetine|Subjects will receive duloxetine capsules in the duloxetine arm.
15833192|NCT04178980|Drug|Simvastatin in relapsing remitting multiple sclerosis|Simvastatin use as adjuvant thearapy in relapsing remitting multiple sclerosis
15833193|NCT04178967|Biological|Lebrikizumab|Subcutaneous injection
15833194|NCT04178967|Other|Placebo|Subcutaneous Injection
15833195|NCT04178954|Diagnostic Test|semen fluid analysis|semen fluid analysis
15833196|NCT04178941|Behavioral|Audit and Feedback|The audit and feedback intervention includes providing each hospital's own continuous pulse oximetry use data back to them on a weekly basis for review and action.
15833869|NCT04173637|Biological|AK101|an anti-IL-12/23p40 monoclonal antibody
15833199|NCT04178915|Diagnostic Test|Bood leukocyte subsets|Determination of blood leukocyte subpopulations, myeloid suppressor cells of various origins, type 2 congenital lymphoid cells, depleted T cells, CD45RA+ CD45RB+ CD62L-IRC, T-cell differentiation stages (naive - memory cells - effector - terminally differentiated effectors), B cells (CD5+ B1 cells, CD11c+ ABC, differentiation stages: immature - naive - isotype-unswitched memory cells - isotype-switched memory cells - plasmoblast)
15833200|NCT04178915|Diagnostic Test|The cholesterol content of the cell membrane of T-cells and monocytes|The cholesterol content of the cell membrane of T-cells and monocytes with flow cytometry analysis
15833201|NCT04178902|Drug|ABBV-467|Intravenous (IV) Infusion
15833202|NCT04178876|Procedure|ethanol sclerotherapy|Endometrioma laparoscopic aspiration and sclerotherapy using 95% ethanol
15833203|NCT04178876|Procedure|stripping technique|Endometrioma laparoscopic cystectomy
15833204|NCT04178863|Device|CATS Tonometer|latanoprost vs. timolol
15833205|NCT04178863|Drug|Latanoprost|latanoprost IOP reduction
15833206|NCT04178850|Biological|GB242|GB242: Dosing of 3 mg/kg, intravenous drip, to be completed over 120 minutes, dosing at weeks 0, 2, 6, 14 and 22, a total of 5 doses; MTX:Dosage and administration at enrollment are maintained (10~15mg/week), oral administration, a total of 30 doses; Folic acid: 5-10mg/week, oral administration, a total of 30 doses
15833207|NCT04178850|Biological|Infliximab|Infliximab: Dosing of 3 mg/kg, intravenous drip, to be completed over 120 minutes, dosing at weeks 0, 2, 6, 14 and 22, a total of 5 doses; MTX:Dosage and administration at enrollment are maintained (10~15mg/week), oral administration, a total of 30 doses; Folic acid: 5-10mg/week, oral administration, a total of 30 doses
15833209|NCT04178811|Device|Holmium Laser Enucleation of Prostate and Prostatic Uretheral Lift|Use of Holmium Laser Enucleation of Prostate and Prostatic Uretheral Lift in management of Benign Prostatic Hyperplasia
15833210|NCT04178798|Drug|Acalabrutinib 100 MG Oral Capsule|Patients in Arm A will receive acalabrutinib as one capsule of 100 mg orally twice daily on a continuos Schedule.
15833211|NCT04178785|Drug|Remifentanil|Patients electively admitted for laparoscopic hysterectomy will be approached for requirement. After obtaining a written informed consent, patients will be randomly assigned either to the study group (Remifentanil group) or to the control group (Fentanyl group) in a 1:1 ratio.
15833212|NCT04178772|Device|Acuvue Moist Multifocal Contact Lens JJVC Marketed Contact Lens|JJVC Marketed Contact Lens
15833213|NCT04178759|Procedure|Liver resection|Laparoscopic or open approach liver resection where at least 1 segment is removed
15833214|NCT04178746|Device|Artemis Neuro Evacuation Device|"The Artemis Neuro Evacuation Device is used for the controlled aspiration of tissue and/or fluid during surgery of the Ventricular System or Cerebrum in conjunction with a Penumbra Aspiration Pump.
~The Penumbra Aspiration Pump is indicated as a vacuum source for the Penumbra Aspiration Systems.
~The Artemis Device will be evaluated by descriptive statistics in this registry to assess its efficiency and reliability in minimally invasive, mechanical evacuation of hematoma in patients with intracranial hemorrhage under direct visualization and control using a neuroendoscope."
15833215|NCT04178733|Drug|LY3493269 - SC|Administered SC
15833216|NCT04178733|Drug|Placebo - SC|Administered SC
15833217|NCT04178733|Drug|LY3493269 - IV|Administered IV
15833221|NCT04178707|Device|OnZurf Probe, Senzime AB, Uppsala, Sweden|Probe is inserted into the fistula and measurements are made of the inner environment.
15833222|NCT04178694|Device|non-invasive ventilation|non-invasive ventilation will be performed on every subjects
15833223|NCT04178681|Other|100% vegetable blend|Dietary lipid challenge test: 600 ml skimmed milk plus 95 gram of vegetable fat blend.
15833224|NCT04178681|Other|100% AMF|Dietary lipid challenge test: 600 ml skimmed milk plus 95 gram of anhydrous milk fat.
15833225|NCT04178681|Other|100% cream|Dietary lipid challenge test: 600 ml skimmed milk plus 95 gram of anhydrous milk fat plus milk fat globular membranes.
15833226|NCT04178668|Other|Oral mucosa and saliva samples|one oral mucosa sample and one saliva sample
15833227|NCT04178655|Drug|Tranexamic acid injection|1 GRAM TRANEXAMIC ACID INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION
15833228|NCT04178655|Drug|PLACEBO|10 MILILITERS 0.9% NORMAL SALINE INTRAVENOUS BOLUS ONCE PRIOR TO SKIN INCISION AND TOURNIQUET INFLATION
15833229|NCT04178642|Drug|percutaneous destruction of the tumor + Idarubicin-Lipiodol treatment|Patients will receive the standard treatment protocol consisting of a percutaneous destruction of the tumor. In addition they will receive an adjuvant treatment by hepatic arterial chemo-infusion of Idarubicin (Zavedos®, Pfizer), which is an anthracycline antineoplastic agent, mixed with Lipiodol (Lipiodol Ultra-Fluid®, Guerbet), which is a contrast agent.
15833230|NCT04178642|Procedure|Percutaneous destruction of the tumor|Patients will received the standard treatment protocol consisting of a percutaneous destruction of the tumor.
15833231|NCT04178616|Diagnostic Test|olfactory testing with specific odorants (localisation and identification)|Olfactory testing : ETOC (European Test of Olfactory capabilities)
15833232|NCT04178603|Other|Exercise, insulin infusion|Trial A: Acute one-legged exercise Trial B: Insulin infusion 4 hours after one-legged exercise
15833233|NCT04178590|Drug|SRP + Injectable Platelet-Rich Fibrin|Injectable Platelet-Rich Fibrin application as adjunct to scaling and root planing
15833234|NCT04178590|Drug|SRP + placebo|Saline application during scaling and root planing
15833235|NCT04178577|Drug|Tebipenem pivoxil hydrobromide (TBPM-PI-HBr)|Tebipenem pivoxil hydrobromide (TBPM-PI-HBr) 600 mg single-dose given orally.
15833260|NCT04178356|Other|Proprioceptive Neuromuscular Facilitation Training|The Proprioceptive Neuromuscular Facilitation Training will be performed using patterns and techniques in various positions for abdominal and back muscles' facilitation and strengthening. Supine, side-lying, and sitting positions will be used. There will be a rest of about 20 sec between sets. Warm-up for 10 min, main exercises for 25 min, cool-down for 10 min (a total of 45 min), 5 times a week for 4 weeks.
15833870|NCT04173637|Biological|Placebo|matching placebo
15833236|NCT04178564|Behavioral|Cognitive Stimulation|"The intervention includes 50 sessions, over the course of one year, being that 3 of those sessions will be the pretest, intratest and posttest evaluations. The intervention sessions will last approximately 60 minutes and they will be developed according to the following structure:
~Welcoming to the group (5 minutes) Reality orientation therapy (10 minutes) Main activity (35 minutes) Session evaluation (10 minutes) CS sessions will be conducted in groups. The intervention sessions will include several activities based on different non-pharmacological therapies, whose effectiveness in elderly with neurocognitive disorders has been scientifically proven. Non-pharmacological therapies used encompass therapies such as musictherapy, reminiscence therapy, validation therapy, Montessori method in geriatrics, ADL training, art therapy and the computer software Rehacom."
15833237|NCT04178551|Other|Implementation Facilitation|The foundation of CONDUIT's implementation activities are the structured interactions between external facilitation teams and internal facilitation teams. A core set of internal facilitation activities will be used across all facilitation teams, and external facilitation teams will use additional activities based on the needs of their sites or clinical settings.
15833238|NCT04178538|Procedure|ACL reconstruction with bone marrow, demineralized bone marix, and internal brace augmentation|ACL reconstruction with bone marrow, demineralized bone marix, and internal brace augmentation with all inside technique
15833239|NCT04178538|Procedure|Standard ACL reconstruction with all inside technique|Standard ACL reconstruction with all inside technique
15833240|NCT04178525|Device|ChitoCare gel|ChitoCare gel is based on chitosan and used as an addition to standard care, accordingly with dressing change for 10 weeks.
15833241|NCT04178525|Device|Placebo gel|Placebo gel is used as an addition to standard care, accordingly with dressing change for 10 weeks.
15833242|NCT04178512|Drug|Drug:dexamethasone in group Dexamethasone,fentanyl in group Fentanyl,normal saline 0.9%in group Control|prevention of shivering after spinal anesthesia in patients undergoing trans urethral prostatectomy through injection of spinal additives
15833243|NCT04178499|Diagnostic Test|cytokine analysis|analysis of intraocular cytokines
15833244|NCT04178486|Behavioral|Hypnosis with amnesia suggestions|Participants received hypnotic induction with hypnotic suggestions for their eating behaviors.
15833245|NCT04178486|Behavioral|Hypnosis with cognitive rehearsal suggestions|Participants received hypnotic induction with hypnotic suggestions for their eating behaviors.
15833246|NCT04178486|Behavioral|Hypnosis with memory substitution suggestions|Participants received hypnotic induction with hypnotic suggestions for their eating behaviors.
15833247|NCT04178486|Behavioral|Hypnosis with induction only|Participants received only hypnotic induction.
15833248|NCT04178473|Procedure|total abdominal hysterectomy|total abdominal hysterectomy at time of sacrocolpopexy
15833249|NCT04178473|Procedure|Subtotal abdominal hysterectomy|Subtotal abdominal hysterectomy at time of sacrocolpopexy
15833250|NCT04178460|Drug|Niraparib combined with MGD013|"The dose escalation part will enroll about 9 - 24 Gastric cancer (including gastroesophageal junction cancer) subjects, with fixed dose niraparib (200mg or 300mg) combined with MGD013 (120mg, 300mg or 600mg ) in different dose level.
~For the dose expansion part, patients with advanced or metastatic Gastric cancer (including gastroesophageal junction cancer), Triple negative breast cancer, Biliary tract carcinoma, Endometrial carcinoma will be enrolled, about 35 subjects for each expansion cohort during dose expansion phase with fixed dose niraparib (200mg or 300mg) combined with fixe dose MGD013 (to be confirmed after dose escalation)."
15833251|NCT04178447|Drug|Glepaglutide|Single dose of Glepaglutide 10 mg
15833253|NCT04178421|Other|Computerized training program|Eye-gaze fixation computer based training program
15833254|NCT04178421|Other|Placebo|Pac-Man, Zookeeper, Tetris
15833255|NCT04178408|Other|No intervention|No intervention
15833256|NCT04178395|Device|bihemispheric transcranial direct stimulation|"tDCS was applied with the anode placed over the M1 hand area of the ipsilesional motor cortex and the cathode over the same area of the contralesional motor cortex (C3/C4). For the active condition, patients received 5 consecutive daily sessions of 2 mA anodal tDCS over the AH and cathodal tDCS over the UH of 20 minutes each, with fade-in and fade-out periods of 1s. For the sham condition, the stimulation applied in the same sites and with the same parameters, was turned off after a fade-in period, 30 seconds of direct current stimulation and a fade-out period.
~Repetitive peripheral nerve stimulation was performed by a peripheral nerve stimulator to the radial nerve and applied at the same time as tDCS. Radial nerve was chosen to improve wrist extension. Trains of 40 stimuli (ISI: 10 ms, duration: 1ms) were delivered every 6 seconds to the radial nerve through bipolar electrodes (5 cm diameter) at an intensity that could elicit a visible wrist extension (20-30 mA)."
15833257|NCT04178382|Diagnostic Test|PCR-CRISPR／Cas12a detection|Evaluate whether the combination of PCR and CRISPR/Cas12a detection of alveolar lavage fluid changes the choice of early antibiotics in patients with pneumonia in artificial airways, and whether it changes the prognosis compared with traditional pathogenic microbial detection techniques.
15833258|NCT04178369|Other|Proximal And Distal Tibiofibular Joint Manipulations|"For PTFJ, the experimental intervention will be based on previously published methods. Physiotherapist will make contact with the fibular head, extending to the popliteal fossa. The associated soft tissue will be pulled in a lateral direction until the metacarpophalangeal joint will be firmly stabilized behind the fibular head.
~For DTFJ, the experimental intervention will be conducted according to previously published methods. Physiotherapist will grasp and stabilize the distal tibia with one hand and grasp the distal fibula between the finger and thenar eminence of the other hand. The fibula will be translated posteriorly until the restrictive barrier (end range) will be engaged. Then a high-velocity, low-amplitude thrust will be applied through the fibula in a posterior-superior direction."
15833259|NCT04178369|Other|Bobath Treatment|All participants will be given a 6-week-long physiotherapy and rehabilitation program based on the Bobath concept for 5 days a week, 45 minutes each. The techniques will be applied by a physiotherapist who is specialized in Bobath concept. 35 different techniques will be used to improve the selective control and weight transfer of the pelvis in sitting, standing and supine/side lying positions. Moreover, soft tissue mobilization will be also used to relieve tension and loosen stiff tissues to provide biomechanical alignment and reduce pain.
15833329|NCT04177953|Drug|Pemetrexed 500 mg/m2|chemotherapy iv
15833330|NCT04177953|Biological|Nivolumab Injection|Human monoclonal antibody
15833261|NCT04178356|Other|Control Group|Ultrasound, TENS, massage, and exercise will be used with each other because in most of the physical therapy clinics these modalities are used together for such problems as a conventional treatment. After massage application, hamstring and paravertebral muscles stretching and also stabilizing exercises will be prescribed, each one for ten times in each session.
15833262|NCT04178343|Radiation|tomotherapy|"the prescription of tomotherapy: whole brain radiation (WBRT) with 40Gy in 20 fractions and concurrent boost of 60Gy of the leptomeningeal metastases;
~WBRT of 50Gy in 25 fractions, with dose limitation of hippocampus and brain stem; c.TMZ is used if necessary: concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/ m2*5d, q28d, up to 6cycles.
~d. Some patients received intrathecal chemotherapy (MTX+AraC+Dex) based on the cytology of cerebrospinal fluid (CSF)."
15833263|NCT04178330|Radiation|tomotherapy|Whole brain radiation (WBRT) with 38-40Gy in 20 fractions and concurrent boost of 60-70Gy of the lesions. TMZ is used if necessary: concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/ m2*5d, q28d, up to 6cycles.
15833264|NCT04178304|Drug|Prolotherapy with 25% Dextrose|Intra-articular injection of 6mL of 25% dextrose Extra-articular injection at tender sites with 25% dextrose
15833265|NCT04178291|Device|Ultrasonic scaler and Gracey currettes|Full mouth subgingival debridement using ultrasonic scaler and Gracey currettes
15833266|NCT04178291|Device|Air polishing with erythritol powder|Air flow PLUS
15833267|NCT04178278|Diagnostic Test|Shuttle walking test|Patients will be required to walk around a 10-m course marked by cones placed 9 m apart, thus allowing 0.5 m for turning at each end. Walking speed will be regulated by prerecorded signals on a compact disc or MP3 file. Patients will increase walking speed at every minute. patients can stop this study, when they can not maintain their speeds due to dyspnea
15833268|NCT04178278|Diagnostic Test|Exercise stress test|Exercise stress test will be performed with cycle. When patients perform this study, they will gradually increase the velocity. Investigators will measure electrocardiography, vital sign, oxygen saturation, oxygen uptake, minute ventilation and fatigue.
15833269|NCT04178278|Diagnostic Test|6 minutes walking test|When participants perform 6 minutes walking test, patients will walk around the tract during 6 minutes. They can their walking speed according to condition and symptom. Investigators records walking distance, pulse rate, oxygen saturation and Borg scale
15833270|NCT04178265|Other|Electroacupuncture|needles were inserted to Kunlun(BL60), Yanglingquan (GB34), Sanyinjiao(SP6), Taixi (KI 3) contralateral to the operated leg and deqi sensation elicited at acupoints.
15833271|NCT04178252|Other|mask|investigators will add eye mask to standard treatment
15833272|NCT04178252|Other|headset|investigators will add headset to standard treatment
15833273|NCT04178252|Other|standard drug|investigators will use 10 mg metoclopramide in 150 ml saline given IV over 10 minutes
15833274|NCT04178239|Diagnostic Test|fMRI, questionnaires, pneumologic diagnostics|fMRI neuropsychological questionnaires pneumologic diagnostics: blood samples, whole body plethysmography, walking test
15833275|NCT04178226|Other|Manual Acupuncture|The acupoints choose are (RN6) (RN4) (SP6) (PC6) (SP10) (SP4)
15833276|NCT04178226|Device|Laser Acupuncture|The acupoints choose are (RN6) (RN4) (SP6) (PC6) (SP10) (SP4)
15833277|NCT04178213|Device|Implantation of ADAPT 3D ALR|The operation is performed through a median sternotomy and with the hemodynamic support of standard cardiopulmonary bypass (CBP). diseased leaflets are excised meticulously. Calcifications at the level of the annulus will be removed just like in any other aortic valve replacement procedure. The annulus will be sized and the appropriate 3D single piece valve will be chosen. The implant technique will consist out of one running suture line at the level of the annulus, followed by fixation of the 3 commissural parts against the aortic wall. Valve competence and function will be assessed visually, and by TEE immediately coming of bypass.
15833278|NCT04178200|Drug|Lidocaine 2% Injectable Solution 0.75 ml|0.75 ml of Lidocaine will be added to the anesthetic solution.
15833279|NCT04178200|Drug|Bupivacaine Hcl 0.5% Inj 0.75 ml|0.75 ml of Bupivacaine will be added to the anesthetic solution.
15833280|NCT04178200|Drug|Lidocaine 2% Injectable Solution 1.5 ml|1.5 ml of Lidocaine will be added to the anesthetic solution.
15833281|NCT04178200|Drug|Bupivacaine Hcl 0.5% Inj 1.5 ml|1.5 ml of Bupivacaine will be added to the anesthetic solution.
15833282|NCT04178187|Drug|Caps Lactolevure|One group will receive Caps Lactolevure x2 and the other group Caps Placebo x2.
15833283|NCT04178187|Drug|Caps Placebo|Caps Placebo
15833284|NCT04178174|Radiation|SABR boost and de-escalated chemoradiation|Stereotactic body radiotherapy boost to the gross tumor volume to a dose of 14 Gy in 2 fractions, followed by cisplatin-based chemoradiation to a dose of 40 Gy in 20 fractions
15833285|NCT04178174|Radiation|Standard chemoradiation|Standard Cisplatin-based chemoradiation to a dose of 70 Gy in 33 fractions
15833286|NCT04178161|Device|Laser treatment|Iontophoresis of methylene blue is used to identify the sweat glands. An image guided fractional erbium laser is used to specifically target these glands for ablation.
15833287|NCT04178148|Other|Amikacin dose optimization|Therapeutic drug optimization of amikacin using the BestDose software algorithm
15833288|NCT04178135|Drug|rLH|rLH supplement from day 1 of stimulation
15833289|NCT04178135|Drug|rLH|rLH supplement from day 6 of stimulation
15833290|NCT04178122|Genetic|Result disclosure|Disclosure of clinically confirmed, medically actionable genetic testing results and post-test genetic counseling session.
15833291|NCT04178109|Drug|Dexketoprofen/tramadol (27mg/75mg)|Postoperatively patients in Group A received the oral combination dexketoprofen/tramadol for the treatment of acute postoperative pain the first 72h
15833292|NCT04178109|Drug|Tramadol hydrochloride|Patients in group B received IV tramadol 75mg every 8h
15833293|NCT04178109|Drug|Paracetamol|Patients in group B received IV paracetamol 1g every 8h
15833294|NCT04178109|Drug|Ropivacaine Hydrochloride 7.5 MG/ML|300mg ropivacaine as periarticular injection in a dilution of 100ml n/s 0,9% was done by the orthopedic surgeon in all patients
15833295|NCT04178109|Drug|Levobupivacaine Hydrochloride|10-15mg levobupivacaine was done subarachnoidal for spinal anesthesia
15833359|NCT04177719|Drug|Placebo|Saline placebo will be given intranasally. The order of administration will be counterbalanced
15833360|NCT04177706|Drug|Ketamine Hydrochloride|Participants receiving the active study medication will receive 60 mg ketamine twice per week for four weeks under clinical supervision.
15833296|NCT04178096|Other|Quality Improvement Intervention|The investigators will assess the effectiveness of empirically determined implementation strategies that are associated with increasing cirrhosis evidence based practices and thus improving outcomes of Veterans with cirrhosis by introducing a bundle of these strategies to four new 'low-performing' hospitals every six months during and eighteen month period in this stepped wedge cluster randomized trial.
15833297|NCT04178083|Diagnostic Test|medical examination|medical examination
15833298|NCT04178070|Biological|GB224 2mg|2mg (100μL), single dose, abdominal subcutaneous injection
15833299|NCT04178070|Biological|GB224 5mg|5mg (250μL), single dose, abdominal subcutaneous injection
15833300|NCT04178070|Biological|GB224 10mg|10mg (500μL), single dose, abdominal subcutaneous injection
15833301|NCT04178070|Biological|GB224 15mg|15mg (750μL), single dose, abdominal subcutaneous injection
15833302|NCT04178070|Biological|GB224 20mg|20mg (1mL), single dose, abdominal subcutaneous injection
15833303|NCT04178070|Biological|GB224 30mg|30mg (1.5mL), single dose, abdominal subcutaneous injection
15833304|NCT04178070|Other|Placebo, 2mg|2mg (100μL), single dose, abdominal subcutaneous injection
15833305|NCT04178070|Other|Placebo, 5mg|5mg (250μL), single dose, abdominal subcutaneous injection
15833306|NCT04178070|Other|Placebo, 10mg|10mg (500μL), single dose, abdominal subcutaneous injection
15833307|NCT04178070|Other|Placebo, 15mg|15mg (750μL), single dose, abdominal subcutaneous injection
15833308|NCT04178070|Other|Placebo, 20mg|20mg (1mL), single dose, abdominal subcutaneous injection
15833309|NCT04178070|Other|Placebo, 30mg|30mg (1.5mL), single dose, abdominal subcutaneous injection
15833310|NCT04178057|Biological|GB222 3mg/kg|Injection, strength 100mg/bottle, intravenous infusion, 3mg/kg, dose escalation; After it is tolerated, 2 weeks/per time, combines use of chemotherapeutic agents is allowed after 3 months until disease progression, death, intolerable toxic reactions, withdrawal of informed consent form, loss to follow-up, death or study conclusion; low dose group.
15833311|NCT04178057|Biological|GB222 5mg/kg|Injection, strength 100mg/bottle, intravenous infusion,5mg/kg, dose escalation; After it is tolerated, 2 weeks/per time, combines use of chemotherapeutic agents is allowed after 3 months until disease progression, death, intolerable toxic reactions, withdrawal of informed consent form, loss to follow-up, death or study conclusion; intermediate dose group 1.
15833312|NCT04178057|Biological|GB222 7.5mg/kg|Injection, strength 100mg/bottle, intravenous infusion,7.5mg/kg, dose escalation; After it is tolerated, 2 weeks/per time, combines use of chemotherapeutic agents is allowed after 3 months until disease progression, death, intolerable toxic reactions, withdrawal of informed consent form, loss to follow-up, death or study conclusion; intermediate dose group 2.
15833313|NCT04178057|Biological|GB222 10mg/kg|Injection, strength 100mg/bottle, intravenous infusion,10mg/kg, dose escalation; After it is tolerated, 2 weeks/per time, combines use of chemotherapeutic agents is allowed after 3 months until disease progression, death, intolerable toxic reactions, withdrawal of informed consent form, loss to follow-up, death or study conclusion; high dose group.
15833314|NCT04178044|Biological|GB223,7mg/kg|Injection; strength of 70mg/1ml/vial; subcutaneous injection; GB223:7mg/kg 2 subjects receive placebo.
15833315|NCT04178044|Biological|GB223,21mg/kg|Injection; strength of 70mg/1ml/vial; subcutaneous injection; GB223:21mg/kg 2 subjects receive placebo. The next dose group can be initiated only after the safety and tolerability are confirmed within 4 or 8 weeks after the previous dose is given.
15833316|NCT04178044|Biological|GB223,63mg/kg|Injection; strength of 70mg/1ml/vial; subcutaneous injection; GB223:63mg/kg 2 subjects receive placebo. The next dose group can be initiated only after the safety and tolerability are confirmed within 4 or 8 weeks after the previous dose is given.
15833317|NCT04178044|Biological|GB223,119mg/kg|Injection; strength of 70mg/1ml/vial; subcutaneous injection; GB223:119mg/kg 2 subjects receive placebo. The next dose group can be initiated only after the safety and tolerability are confirmed within 4 or 8 weeks after the previous dose is given.
15833318|NCT04178044|Biological|GB223,140mg/kg|Injection; strength of 70mg/1ml/vial; subcutaneous injection; GB223:140mg/kg 2 subjects receive placebo. The next dose group can be initiated only after the safety and tolerability are confirmed within 4 or 8 weeks after the previous dose is given.
15833319|NCT04178031|Device|IUD insertion|"Insert a warm, moistened speculum. Cleanse the cervix with an antiseptic solution. Apply gentle traction with the tenaculum to straighten the canal. Remove the sound by its handle and gently insert to measure the depth of the uterus. Do not apply great force if there is resistance. Apply further traction to the tenaculum and attempt to re-insert the sound at a different angle. Once the sound is inserted and removed, note the depth of the uterine cavity. The woman can expect to feel cramping as the sound is inserted and withdrawn.
~Load the IUD and insert it into the uterine cavity according to the manufacturer instructions. As the IUD is inserted through the cervix into the uterus, the patient may have pain and cramping similar to strong menstrual cramps.
~Gently remove the tenaculum. Trim the strings of the IUD to 3-4 cm in length Remove the speculum and assess the woman."
15833320|NCT04178018|Device|Photoacoustic imaging|-Emerging technique in which a short-pulsed laser beam penetrates diffusively into a tissue sample
15833321|NCT04178018|Device|Ultrasound|-The ultrasound is being used in conjunction with the photoacoustic imaging
15833322|NCT04178005|Drug|Cladribine|All study participants will receive treatment with cladribine 10 mg tablets at the recommended cumulative dose of 3.5 mg/kg, divided into 2 yearly treatment courses (1.75 mg/kg per treatment course). This regimen corresponds to the recommended dosage as per the USPI
15833323|NCT04177992|Other|Servo control|FiO2 adjustments will be made by one of two respiratory devices depending on the clinical requirements and current ventilatory therapy of the infant
15833324|NCT04177979|Behavioral|Near-assisted learning through trained peers|Students randomly allocated to this group were overseen during sessions by trained peer instructors.
15833325|NCT04177966|Behavioral|pre-prepared video describing the cesarean surgery|a pre-prepared video, approximately 10 minutes in length, showing in detail the course of events around the operation - from the woman's perspective - from the time they were admitted to the department, preparation for surgery, entrance to the operating r
15833326|NCT04177966|Behavioral|general information|In the control group - women will receive general information about the surgery as part of informed consent, without watching a pre-prepared film.
15833327|NCT04177953|Drug|Carboplatin AUC 5|chemotherapy iv
15833328|NCT04177953|Drug|Cisplatin 75 mg/m2|chemotherapy iv
15833331|NCT04177940|Drug|DMAB Discontinuation and Switching|"Investigators will test the hypothesis that an increase in bone turnover markers (e.g. CTX and P1NP) in patients currently taking chronic glucocorticoids will be attenuated more in those who switch from denosumab to late zoledronic acid (9 months after last denosumab dose) compared to participants randomized to early zoledronic acid (6 months after last denosumab dose) or weekly alendronate (6 months after last denosumab dose"
15833332|NCT04177927|Device|Capnostream 20p / Coviden|The special nasal canule is used for detection carbondioxide from breathe of patients
15833333|NCT04177927|Device|Rutine monitoring|peripheric Oxygen saturation is monitored.
15833336|NCT04177901|Device|Near infrared spectroscopy|It is used for detection of tissue oxygenation
15833337|NCT04177888|Device|Hot Pack|It is a single-use pack filled with magnesium sulfate and water, which was squeezed between the hands to activate their warming effect. The temperature ranges between 40°C to 50°C, which is safe to use. Thus, it provided a consistent heat therapy for up to 30 minutes. They can be used directly on the skin or covered with gauze to avoid direct skin contact. Applied to the lower back area for 30 minutes, followed by 10 minutes rest between each hot pack application, then it was reapplied for another 30 minutes. This procedure was repeated till delivery.
15833338|NCT04177875|Drug|Teripalimab|Teripalimab Injection 240mg/6ml fixed dose (3mg/kg for patients weighing less than 40kg) ,injection on day 1, each infusion for 30min (no less than 60 minutes for the first injection); every 3 weeks. docetaxel dose was 75mg/m2, injection on day 1;Albumin-bound Paclitaxel (no anti-allergic treatment required), 260mg/m2, injection on day 1; Cisplatin was 75mg/m2, injected on day 1.A total of two treatment cycles.
15833339|NCT04177862|Drug|Sublingual Sufentanil|30 mcg of sublingual sufentanil
15833340|NCT04177862|Drug|IV Fentanyl|50 mcg of IV fentanyl
15833341|NCT04177849|Procedure|ACDF|A 4-cm anterolateral transverse incision is made over the index level, on either the right or left side. Platysma is sectioned transversal to its fibers and the anterior aspect of the spinal column is bluntly exposed between the carotid sheath and the esophagus. The disk is excised, including the posterior longitudinal ligament. Disk fragments and/or osteophytes from the uncovertebral joint on the affected side are removed until the root is fully decompressed. Reconstruction is typically done with an interbody spacer, autologous bone graft and a stabilizing plate screwed to the adjacent vertebral bodies. A fusion cage with integrated screws may also be used according to the surgeon's preference.
15833342|NCT04177849|Procedure|PF|A 4-cm longitudinal midline incision exposes the spinous processes of the adjacent vertebrae. The facet joint covering the index foramen is exposed through intermuscular planes. The root canal is opened as the medial third of the facet joint is removed with a high-speed diamond burr. The affected nerve root is decompressed by laterally undercutting the facet joint throughout its length.
15833343|NCT04177836|Behavioral|Mindfulness intervention|Participants will either complete a mindfulness intervention or active control for 2 weeks on their smartphone
15833344|NCT04177823|Drug|Belantamab mafodotin|Belantamab mafodotin will be available as lyophilized powder 100 mg/vial in single-use vial for reconstitution. It will be administered at a calculated dose of 2.5 mg/kg or 3.4 mg/kg as an IV infusion on Day 1 of each cycle over 30 minutes.
15833345|NCT04177810|Drug|Cemiplimab|"Patients will receive treatment Day 1 of each cycle (21 days) for up to 2 years.
~Drug: Cemiplimab (350 mg) will be administered IV on day 1 (21 day cycle)."
15833346|NCT04177810|Drug|Plerixafor|"Patients will receive treatment on the first 7 days of each cycle (21 days) for up to 2 years.
~Drug: Plerixafor (80mcg/kg/hr) will be administered as a continuous IV infusion of the first 7 days of each cycle (21 days cycle)."
15833347|NCT04177797|Drug|Toripalimab|Two cycles of Toripalimab(240 mg administered as an intravenous infusion over 30 minutes per 3 weeks), concurrently paclitaxel(135 mg/m2) and carboplatin(AUC 5) administered as an intravenous infusion per 3 weeks.
15833348|NCT04177784|Other|Online Educational Videos|The videos were developed by the researchers based on a prior study to test if specific information about obesity and weight control influence weight bias.
15833349|NCT04177758|Drug|Vitamin D|Patients randomized to the experimental arm of the study will receive 50,000IU of vitamin D3 following surgery and asked to take the medication orally following surgery.
15833350|NCT04177758|Drug|Control|Patients randomized to the control will receive a placebo
15833351|NCT04177745|Other|Hot application|Before PVC was inserted, the researcher applied a hot application to the catheter insertion site (inner surface of the forearm) using a hot pack for one minute.
15833352|NCT04177745|Other|Cold application|Before PVC was inserted, the researcher applied a cold application to the catheter insertion site (inner surface of the forearm) using a cold pack for one minute.
15833353|NCT04177732|Diagnostic Test|Collection of sulcular (crevicular) fluid|Sterile paper strips will be used for collecting crevicular fluid
15833354|NCT04177732|Diagnostic Test|Probing depth|Williams SE manual probe will be used to measure the probing depth
15833355|NCT04177732|Diagnostic Test|Bleeding on probing|Williams SE manual probe will be used to probe the sulcus a oserve the gingival reaction
15833356|NCT04177732|Diagnostic Test|Gingival index|Modified Löe and Silness criteria will be used for evaluating the gingival index score
15833357|NCT04177732|Diagnostic Test|Bone loss rate of alveolar bone|Using modification of criteria described by Schei et al, bone loss rate of alveolar bone will be analyzed on radiographic assessment
15833358|NCT04177719|Drug|Oxytocin|oxytocin will be given intranasally. The order of administration will be counterbalanced
15833362|NCT04177693|Dietary Supplement|Epigallocatechin gallate (EGCG)|800 mg (2 capsules) of decaffeinated EGCG (green tea extract), taken orally on a daily basis for up to 2 months
15833363|NCT04177693|Drug|Clomiphene Citrate|100 mg for 5 days
15833364|NCT04177693|Drug|Letrozole|5 mg for 5 days
15833365|NCT04177680|Drug|Omega 3 pentaenoic acid|Encapsulated omega-3 pentaenoic acid
15833366|NCT04177680|Drug|icosapent ethyl|Encapsulated omega-3 acid ethyl esters
15833367|NCT04177667|Dietary Supplement|Proxeed|Treatment with dietary supplement for male infertility for Proxeed Arm
15833368|NCT04177667|Other|Placebo|Treatment with placebo for Placebo Arm
15833369|NCT04177654|Drug|Benzimidazoles|A single dose of benzimidazole drug (400mg Albendazole or 500mg Mebendazole) will be administered as part of routine deworming services.
15833370|NCT04177641|Diagnostic Test|Disulphide(μmol/L)|Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry
15833371|NCT04177641|Diagnostic Test|Total Oxidant Capacity(μmolH2O2Equiv/L)|Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry
15833372|NCT04177628|Behavioral|Shared decision making supported by an in-consultation patient decision aid|After having receiving training in SDM, the doctor will practice SDM supported by an in-consultation PtDA during the consultation with the participant.
15833373|NCT04177615|Procedure|Thromboectomy|Thromboectomy in Basilar Artery Occlusion patients
15833374|NCT04177602|Combination Product|Trifluridine/tipiracil chemoradiation|Trifluridine/tipiracil based chemoradiation
15833375|NCT04177602|Combination Product|Capecitabine based chemoradiation|Capecitabine based chemoradiation
15833376|NCT04177589|Other|Incidence of Delirium in Inpatient Elderly Patients|Study design: prospective cohort study.
15833377|NCT04177576|Biological|2 additional tubes of blood|2 additional tubes of blood will be collected to prepare plasma aliquots used tomeasure markers of neutrophil activation
15833378|NCT04177563|Other|whole body cryostimulation|Whole-body cryotherapy
15833379|NCT04177537|Device|Low Intensity Continuous Ultrasound|3MHz, 0.132W/cm2, 1.3W for 4 hours day delivered by an acoustic device provided by Zetroz Systems LLC
15833380|NCT04177524|Device|Background Mode|The LifeSaver app tracks the date, time, and global positioning system (GPS) location of each trip that the participant takes in a moving vehicle, along with a list of apps used during the trip, but does not contain any anti-distracted driving features.
15833381|NCT04177524|Device|Manual Mode|"In addition to the features in the Background Mode, the LifeSaver app locks the participants' phone while they are in a moving vehicle unless they actively press an Emergency Unlock or Passenger Unlock button."
15833382|NCT04177524|Device|Auto-Detect Mode|"In addition to the features in Manual Mode, the LifeSaver app's Passenger Unlock feature can only be used if the app, via the smartphone's camera, confirms that the participant is not the driver of the vehicle."
15833383|NCT04177511|Device|Transcutaneous Auricular Vagus Nerve Stimulation|"Transcutaneous Auricular Vagus Nerve Stimulation has an eartip connected to an external stimulator. The device used in this study is the TENS Eco Plus commercialized by Schwa Medico and European Compliance (CE) marked.
~The electrode is positioned in the cymba concha of the left ear."
15833384|NCT04177498|Drug|Rigosertib Sodium|given PO or 72 hour continuous infusion
15833385|NCT04177498|Other|Quality-of-Life Assessment|Ancillary studies
15833386|NCT04177485|Behavioral|SMS text reminders|SMS reminders (in English and the local language) for the 2nd dose of Pentavalent vaccine were sent 28, 30 and 32 days after the 1st dose. SMS reminders for the 3rd dose of Pentavalent vaccine were sent 61, 66, and 68 days after the 1st dose. SMS reminders for the measles-containing vaccine were sent 274, 279, and 281 days after the child's date of birth.
15833387|NCT04177472|Behavioral|Obesity Prevention Group|Parents will be provided with responsive feeding coaching to help them recognize hunger and satiety cues and nutrition coaching that involves recommending a sequence of introducing complementary foods that corresponds with food textures and feeding styles, breast/bottle weaning, healthy snacking and hands on demonstrations for healthy food options.
15833388|NCT04177459|Behavioral|Health promoting dialogue|Health promoting dialogues based on the salutogenic theory, focusing on resources within and around the individual, and on coping strategies. Seven individual dialogues for each participant, individually adapted due to the fatigue. The intervention is offered in the participants home or at the local hospital, dependent on the participants fatigue and what is preferred.
15833389|NCT04177459|Other|standard treatment / treatment as usual|Follow-up from primary and secondary health care, and from schools.
15833390|NCT04177446|Dietary Supplement|a production consist of various oligopeptides and the whey protein|patients will be given extra protein intake except the basic energy intake
15833391|NCT04177446|Dietary Supplement|basic energy intake|supplement as basic energy intake
15833392|NCT04177446|Dietary Supplement|maltodextrin|used as placebo in the control group
15833393|NCT04177433|Drug|Depo-Medrol Injectable Product|Corticosteroid
15833394|NCT04177433|Drug|Saline|Placebo
15833395|NCT04177420|Device|FIR-C mattress|infrared-C irradiation by hot mattress with a powered heating compress
15833396|NCT04177420|Device|FIR-C abdominal pad|infrared-C irradiation by hot abdominal pad with a powered heating compress
15833397|NCT04177420|Device|fake FIR-C mattress|normal mattress with fake controller, custom make for placebo group
15833398|NCT04177420|Device|fake FIR-C abdominal pad|normal abdominal pad with fake controller, custom make for placebo group
15833399|NCT04177407|Procedure|Standard laparoscopic ELAPE with pelvic peritoneal floor reconstruction using bladder peritoneum flap are to performed.|Standard laparoscopic ELAPE with pelvic peritoneal floor reconstruction using bladder peritoneum flap are to performed.
15833401|NCT04177381|Procedure|Cesarean section|"Abdominal Incision: Pfannenstiel incision Sharp dissection will be continued through the subcutaneous layer to the fascia.
~The fascia will be then incised sharply at the midline
~The transversalis fascia and pre peritoneal fat will be dissected carefully
~The peritoneum will be then incised.
~Low Transverse Cesarean Incision. Bladder flap creation effectively moves the bladder away from the planned hysterotomy site
~Delivery of the Fetus and placenta.
~Uterine Repair in two layers of continuous 0-or No.1 absorbable suture."
15833402|NCT04177381|Procedure|subcutanous sutures|suture closure of subcutaneous tissue with interrupted 2-0 polyglactin 910 (Vicryl).the stitch interval is 1cm
15833403|NCT04177381|Device|subcutanous drain|Inthedraingroup,aclosednonvacuum drain willbeinsertedin thetissueandexitefrom theskinthroughaseparateopeningandstitchto theskin
15833404|NCT04177368|Dietary Supplement|Theragran 60ml|history,examination and biochemical values
15833405|NCT04177355|Biological|BG505 SOSIP.664 gp140|Administered by IM injection
15833406|NCT04177355|Biological|Placebo|Administered by IM injection
15833407|NCT04177355|Biological|3M-052-AF|Administered by IM injection
15833408|NCT04177355|Biological|CpG 1018|Administered by IM injection
15833409|NCT04177355|Biological|GLA-LSQ|Administered by IM injection
15833410|NCT04177355|Biological|Alum (Aluminum Hydroxide Suspension)|Administered by IM injection
15833411|NCT04177342|Drug|Fentanyl|the patients use remifentanil and fentanyl as intra-operatively pain control and compare the post-operative pain condition with the oxycodone group
15833412|NCT04177342|Drug|Oxycodone|the patients use oxycodone and remifentanil as intra-operatively pain control and compare the post-operative pain condition with the fentanyl group
15833413|NCT04177303|Drug|Metformin|Participants will be randomized to metformin 2000 mg
15833414|NCT04177303|Drug|Placebo|Participants will be randomized to placebo
15833415|NCT04177290|Drug|Sintilimab (M1b)|Intravenous infusion
15833416|NCT04177290|Drug|Sintilimab (approved)|Intravenous infusion
15833417|NCT04177264|Procedure|Occipito-Atlantal Decompression (OA DC)|The participant lies supine in a relaxed state while the investigator cradles the patient's head with their hands, middle finger pads along the inferior aspect of inion, reaching to the occipito-atlantal joint. The investigator then applies gentle posterior and cephalad traction to the occiput, while bringing the elbows together. This results in supination of the hands and separation of the middle fingers, creating a posterior-lateral force vector to either side of the foramen magnum. The pressure is maintained until softening of the underlying structures is felt. The procedure is applied for 10 minutes.
15833418|NCT04177264|Procedure|Sham Occipito-Atlantal Decompression (Sham OA DC)|The participant lies supine in a relaxed state while the investigator applies light touch to the patient's head with their hands.
15833419|NCT04177264|Procedure|Splenic Lymphatic Pump Technique (SpLPT)|With the participant supine, the investigator places a posterior hand along the left lower ribcage, and a superior hand over the left costal arch, encompassing the spleen. The investigatory compresses and releases the spleen at a rate of 20 compressions/min for 3 min.
15833420|NCT04177264|Procedure|Sham Splenic Lymphatic Pump Technique (Sham SpLPT)|With the participant supine, the investigator places a posterior hand along the left lower ribcage, and a superior hand over the left costal arch, encompassing the spleen. The investigator will maintain light touch at these positions for 3 minutes. No compressions are performed.
15833421|NCT04177264|Device|Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)|A bipolar clip electrode is attached to the auricle at the location of the cymba conchae. Electrical stimulation (30 Hz stimulation frequency, 300 μs pulse width) is applied for 10 min. The stimulation current is determined individually for each participant by slowly increasing the stimulation current until the participants feel a mild tingling sensation at the site of the electrode. Then the current is gradually reduced until the tingling sensation disappears. This current will then be used for taVNS. A TENS 7000 or EMS 7500 device (510(k): K080661) is used.
15833422|NCT04177264|Device|Sham Transcutaneous Auricular Vagus Nerve Stimulation (Sham taVNS)|A bipolar clip electrode is attached to the auricle at the location of the cymba conchae but no electrical current is applied to the electrode.
15833423|NCT04177238|Dietary Supplement|Fruit concentrate - either cherry or blueberry|Fruit (cherry or blueberry concentrate) supplement from a company named Active-Edge (https://active-edge.co.uk/).
15833424|NCT04177225|Procedure|Trans thoracic Ultrasound Examination|Ultrasound examination of cardiac function before and after induction of general anesthesia.
15833425|NCT04177225|Other|Intravenous fluid administration|Intravenous fluids will be administered as a bolus in response to standard clinical indications
15833426|NCT04177199|Other|TRIAGE HF Pathway|A new care pathway (Triage-HF Plus) for the remote monitoring and management of heart failure stability in a cohort of device patients at 3 hospital sites in North West England.
15833427|NCT04177186|Other|Strength training|Strength training for hamstring and gastrocnemius only, pre and post 12 weeks of intervention
15833428|NCT04177186|Combination Product|Strength training with botulinum toxin|Strength training for hamstring and gastrocnemius with Ultra Sound Imaging method, pre and post 12 weeks of intervention
15833429|NCT04177173|Drug|Simvastatin 20 mg|improvement of disease activity
15833430|NCT04177173|Drug|Methotrexate 10 mg|improvement of disease activity
15833431|NCT04177160|Behavioral|Music|Subjects sit still and listen to preferred music for 5 minutes.
15833432|NCT04177160|Behavioral|White noise|Subjects sit still and listen to white noise for 5 minutes.
15833433|NCT04177147|Other|Clinical decision support via alert tool|The alert tool displays the risk of hypoglycemia for outpatients with diabetes mellitus.
15833434|NCT04177121|Other|qualitative analysis|Qualitative analysis of physiotherapy prescriptions
15833435|NCT04177108|Drug|Atezolizumab|Atezolizumab will be administered to participants by intravenous (IV) infusion at a fixed dose of 840 mg on Days 1 and 15 of each 28-day cycle until unacceptable toxicity.
15833436|NCT04177108|Drug|Ipatasertib|Ipatasertib will be administered to participants at a starting dose of 400 mg QD PO (one tablet a day orally) for 21 days of each 28-day cycle on Days 1 - 21 unless held for management of adverse events.
15833437|NCT04177108|Drug|Paclitaxel|Paclitaxel will be administered to participants at a starting dose of 80 mg/m^2 by IV infusion for 3 of 4 weeks on Days 1, 8, and 15 of each 28-day cycle unless deferred to Day 22 because of an adverse event.
15833438|NCT04177108|Drug|Placebo for Atezolizumab|Placebo will be administered to participants at a fixed dose of 840 mg IV infusion for Atezolizumab on Days 1 and 15 of each 28-day cycle until unacceptable toxicity.
15833439|NCT04177108|Drug|Placebo for Ipatasertib|Placebo will be administered to participants at a starting dose of 400 mg QD PO (one tablet a day orally) for Ipatasertib for 21 days of each 28-day cycle on Days 1 - 21 unless held for management of adverse events.
15833440|NCT04177095|Diagnostic Test|Allosure|Monthly monitoring of dd-cfDNA levels in blood
15833441|NCT04177095|Drug|Immunosuppression reduction|Stepwise reduction in the dose, and ultimate discontinuation of, all non-belatacept immunosuppression (mycophenolate, sirolimus, everolimus, prednisone) guided by monitoring of Allosure and Trugraf results
15833442|NCT04177095|Diagnostic Test|Trugraf|Monthly monitoring of Trugraf result
15833443|NCT04177082|Combination Product|PXL-330 Platinum device for crosslinking with Peschke riboflavin solution|Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea
15833444|NCT04177069|Dietary Supplement|Visucomplex Plus|capsule contains: Lutein, Zeaxanthin, alphalipoic acid MATRIX, Vitamine E, Zinc, Maquibright® (Aristotelian chilensis berry standardized, containing Anthocyanin and delphinidin extracts), Vitamin D and cupper.
15833445|NCT04177056|Radiation|SBRT|Patients will received a single fraction of 15-20 Gy to bone metastases causing pain. Planning and delivery will be conducted using a volumetric modulated arc therapy (VMAT) approach on the Varian TrueBeam platform. Patients will be CT simulated, with vac-lock immobilization. Use of 4-dimensional CT will be dependent on the area being treated. Daily image guidance will be performed using cone beam CT aligning to relevant bony anatomy.
15833446|NCT04177043|Diagnostic Test|HCV antibody and hepatitis B surface antigen (HBsAg) rapid diagnostic tests|HCV antibody and hepatitis B surface antigen (HBsAg) rapid diagnostic tests
15833447|NCT04177043|Drug|DAAs|Treatment with different regiments with DAAs
15833448|NCT04177030|Behavioral|Isopesticide dietary scheme|"All participants should collect first morning urine samples on specific days during the first week and during the third week. Day indicated as 8th, represents the first day of the following week (first day of the wash-out week and first day of the fourth week which is the last day of the study). The participants are asked to consume 4 portions of fruit and 2 portions of vegetables per day during the two trial periods. Overall, dietary daily consumption of foods and fluids will be monitored with the use of a dietary diary throughout the study. Participants will also be asked to take a photograph of the ready to be consumed fruit and vegetable on actual time of consumption and share photos with research team in order to verify at a minimum whether the pre-set time-restriction criteria have been met."
15833449|NCT04177030|Behavioral|Isopesticide dietary scheme|"All participants should collect first morning urine samples on specific days during the first week and during the third week. Day indicated as 8th, represents the first day of the following week (first day of the wash-out week and first day of the fourth week which is the last day of the study). The participants are asked to consume 4 portions of fruit and 2 portions of vegetables per day during the two trial periods. Overall, dietary daily consumption of foods and fluids will be monitored with the use of a dietary diary throughout the study. Participants will also be asked to take a photograph of the ready to be consumed fruit and vegetable on actual time of consumption and share photos with research team in order to verify at a minimum whether the pre-set time-restriction criteria have been met."
15833450|NCT04177017|Behavioral|Mindfulness-based intervention|"The behavioral intervention was carried out once a week during 60 minutes from May to November, and included mindfulness-based practices sought to foster self-awareness, and dyadic activities sought to awakening subtle perception of the other.
~Group activities, which entailed more than two participants, were also conducted to foster empathic collaboration and prosocialness. Diverse collaborative games were carried out in which mutual help was needed for achieving shared goals in an amusing way .
~Perspective-taking was encouraged within the group, by sharing each participant's experience, which included expressing how each child had felt (i.e., if neglected, ignored or cared for) and whether they had enjoyed helping their peers or no."
15833451|NCT04177004|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allo-HCT
15833452|NCT04177004|Drug|Cyclophosphamide|Given IV
15833453|NCT04177004|Drug|Etoposide|Given IV
15833454|NCT04177004|Radiation|Fractionated Stereotactic Radiation Therapy|Undergo FTBI
15833455|NCT04177004|Drug|Goat Milk|Given human lysozyme goat milk PO
15833456|NCT04177004|Biological|Palifermin|Given IV
15833457|NCT04177004|Drug|Sirolimus|Given PO
15833458|NCT04177004|Drug|Tacrolimus|Given IV and PO
15833459|NCT04176991|Biological|CTI-1601|CTI-1601 is a recombinant fusion protein and is intended to deliver human frataxin, the protein deficient in Friedreich's ataxia
15833460|NCT04176991|Biological|Placebo|Placebo Comparator
15833461|NCT04176978|Drug|Rosuvastatin|Patient in this group will receive Rosuvastatin 20mg daily.
15833462|NCT04176978|Other|Treat-to-target strategy|Patient will receive treat-to-target strategy aiming at minimal disease activity (MDA). If patient cannot achieve MDA, treatment will be escalated.
15833463|NCT04176952|Drug|FOLFOX-A|"nab-paclitaxel: 150mg/m2 IV over 30 minutes, day 1 (administered first).
~Oxaliplatin: 85mg/m2, IV over 2 hours, day 1.
~Folinic acid: 350mg flat dose, IV over 2 hours, day 1.
~Fluorouracil infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours or 48 hours as per local practice.)"
15833464|NCT04176952|Drug|AG|"nab-paclitaxel: 125mg/m2 IV over 30 minutes on days 1, 8 and 15 (administered first).
~Gemcitabine 1000mg/m2 IV over 30 minutes on days 1, 8 and 15 (immediately following nab-paclitaxel)."
15833465|NCT04176939|Biological|HZ/su vaccine (GSK1437173A)|2 intramuscular (IM) doses of the HZ/su vaccine administered- first dose at month 24 and second dose at month 25
15833466|NCT04176926|Diagnostic Test|Electrocardiogram|Diagnostic Test: Simultaneous assessment of heart rhythm by 12-lead ECG and wearable device characterization of heart rhythm.
15833467|NCT04176913|Drug|LUCAR-20S CAR-T cells|An Anti-CD20 Allogeneic CAR-T Cell Therapy in Patients with Relapsed/Refractory Diffuse Large B-Cell, Follicular, Mantle Cell or Small Lymphocytic Lymphoma
15833468|NCT04176900|Other|Ingeo Biopolymer (PLA)|Biopolymer used for 3D-printing of rigid bolus
15833469|NCT04176900|Other|Ecoflex 030|Polymer used for the 3D-printed flexible bolus
15833470|NCT04176887|Drug|Levetiracetam Injection|The levetiracetam dose is 20- 40 mg/kg by intravenous infusion over 15 minute, a rate of 2-5 mg/kg/minute diluted in 100 ml with 0.9% sodium chloride as a single dose.
15833471|NCT04176887|Drug|Phenytoin Injection|Phenytoin dose is 20-40 mg/kg/min by intravenous infusion over 30 minute, diluted with 0.9% sodium chloride to a maximum concentration of 10 mg/ml.
15833472|NCT04176874|Procedure|Robotic-assisted diastasis of the rectus abdominis muscles repair|Diastasis of the rectus abdominis muscles repair using the Intuitiv SI robot
15833542|NCT04176302|Device|Parkinson Holter|The neurologists will receive the wearable report (for medication adjustment, if any as per physician's criteria/judgement)
15833473|NCT04176861|Device|home-based Brainwave Entrainment Technology|Smartphone app-based brainwave entrainment programme using audio stimulation via binaural beats or visual stimulation via flickering lights
15833474|NCT04176848|Drug|CFI-400945|Cycle 1: Days 1-7, then Days 15-21; Cycle 2 on: CFI-400945 orally once daily
15833475|NCT04176848|Drug|Durvalumab|Cycle 2 on: Durvalumab 1500mg IV on Day 1 (28 day cycles)
15833476|NCT04176835|Drug|Oxytocin nasal spray|Single-dose oxytocin will be administered intranasally
15833477|NCT04176822|Other|Educational animated movie group|Watching educational animation movie which were designed by the researcher before operation for fear and pain.
15833478|NCT04176822|Other|Documentary movie group|Watching documentary movie about trees before operation for fear and pain.
15833479|NCT04176809|Other|Routine Assessment of HRQoL coupled with Therapeutic Information|Participants will complete the EORTC-QLQ-C30 and EORTC-QLQ-BR23 questionnaires before their consultation via the CHES software. The scores will then be generated and provided to clinicians in a graphic form, describing scores course. Access to CHES web portal will also be open to participants outside consultation time points, to enable them to monitor HRQoL if necessary. Workshop 1, will help patients to recognize and react to the occurrence of possible adverse effects, and anticipate their occurrence through appropriate preventive means. In workshop 2, participants will have the opportunity to express their representations and experiences related to their diet and the consequences of disease and treatments on diet. In workshop 3, participants can describe their experiences of fatigue and how their life is affected by it. Moreover, they can identify possible causes and finally discuss solutions to better this symptom. Every month, a reminder letter will also be sent to participants.
15833480|NCT04176796|Other|Stratified Transplant Survival|"The transplant survival rate in the table of outcome statistics is stratified into two groups: (i) patients who received excellent donor organs and (ii) patients who received less than optimal donor organs.
~Stratified transplant survival is computed from survival rates of transplant patients who received each quality category of organ.
~excellent transplant survival = [number of patients surviving after transplant with excellent organ]/[number of patients for whom excellent organ was accepted for transplant] marginal transplant survival = [number of patients surviving after transplant with marginal organ]/[number of patients for whom marginal organ was accepted for transplant]"
15833481|NCT04176783|Drug|Opioids|narcotic pain medicine
15833482|NCT04176783|Drug|Opioid-Free|non narcotoc pain medication
15833483|NCT04176770|Procedure|ESP Block|ESP block: bilateral injection of 20 ml of isobaric Bupivacain 0,375% in the paraverebral space T5.
15833484|NCT04176770|Procedure|TAP Block|TAP block: bilateral injection of 15 ml of Isobaric Bupivacain 0,5%
15833485|NCT04176757|Drug|ZN-c5|ZN-c5 study drug to be administered orally daily
15833486|NCT04176744|Other|Uni- and bilateral magnetic phrenic nerve stimulation|Uni- and bilateral magnetic phrenic nerve stimulation using different coils, stimulation patterns (frequency, intensity, number of pulses) and locations (neck, chest).
15833487|NCT04176731|Device|Omnipod Horizon™ Automated Glucose Control System|The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery
15833492|NCT04176705|Drug|Lidocaine Cream|Both sites will have lidocaine 4% topical anesthetic cream (Ferndale Laboratories, Ferndale MI) applied as thin layer and left for 30-45 minutes to minimize discomfort applied before laser treatment.
15833493|NCT04176705|Drug|Triamcinolone Acetonide Cream|Triamcinolone acetonide cream (Bristol-Myers Squibb, Princeton, NJ) at a concentration of 20mg/ml will be applied immediately after treatment to both laser and no-laser sites - as this is often reported and there is some speculation that this may be part of the reason improvement is noted.
15833494|NCT04176705|Device|Fractional Ablative Laser|Applied to only site that is randomized to laser intervention
15833495|NCT04176666|Device|NettOpp|NettOpp is a mobile application for adolescents aged 11-16 years who have been exposed to cyberbullying or cyberaggression.
15833496|NCT04176653|Drug|SLN124 is a GalNAc conjugated double stranded fully modified siRNA. Sodium chloride 0.9% w/v is used as Placebo|IMP will be provided as a solution to be injected by qualified clinical staff in patient's abdomen, upper arms or front of the thighs.
15833497|NCT04176627|Device|Lung ultrasound|One-time lung ultrasound study completed on peritoneal dialysis patients at monthly clinic visit
15833498|NCT04176614|Other|cereal-legume snack|cereal-legume biscuit
15833499|NCT04176614|Other|cereal snack|cereal biscuit
15833500|NCT04176601|Behavioral|Engage coaching|"Participants will complete up to 8 weekly individual Social Engage psychotherapy sessions. Participants will be allotted up to 3 months to complete all sessions, a time-frame that allows for two weeks without meeting to address life stressors such as illnesses that may pop up. All sessions are provided via phone or videocall (Zoom). The first and last session are longer - up to 60 minutes if needed. Middle sessions are shorter (20-45 minutes). Engage is a stepped care psychotherapy in that the simplest strategy is taught first-action planning (a derivative of problem solving therapy)-and barrier strategies are added only if needed. Action plans are designed to address loneliness and social isolation in the context of caregiving demands."
15833501|NCT04176588|Drug|Etrasimod|Drug:Etrasimod Tablet other name:APD334
15833502|NCT04176588|Drug|Placebo|Drug:placebo Tablet
15833503|NCT04176575|Other|Acupuncture|Acupuncture will be provided by a licensed acupuncturist utilizing Dr. Tan's Balancing Method.
15833504|NCT04176562|Device|RTI Spine products|"Interbody fusion devices - intended to help facilitate fusion by providing a platform for bone growth, while maintaining height and decompression.
~Supplemental fixation and/or stabilization devices - are intended to stabilize the spine to allow for fusion to occur, maintain current spinal movement, correct deformities or curvature, treat trauma, spinal stenosis, tumor and pseudarthrosis.
~Bone graft substitute - is intended to aid in fusion."
15833505|NCT04176549|Other|Management of Ectopic Pregnancy|Expectant, Medical or Surgical management of Ectopic Pregnancy
15833506|NCT04176549|Other|Management of termination of pregnancy|Surgical termination of pregnancy
15833510|NCT04176510|Behavioral|Health Coach Intervention|A structured, manualized coaching intervention by a lay Health Coach that employs a standardized positive affect/self-affirmation intervention, not tied to specific chronic diseases, to help motivate patients to learn to implement self-management by setting life goals.
15833511|NCT04176497|Drug|68Ga-HBED-CC-PSMA|Radioactive tracer used during imaging to help detect PSMA expressing tumor cells.
15833512|NCT04176484|Other|Survey|Women age 25 and above who are scheduled for an abdominal procedure and were seen in the General Surgery Clinic will be called and asked to complete a 5-10 minute verbal survey prior to their date of surgery. Some additional information will be gleaned from the medical record during the interview.
15833513|NCT04176471|Other|Therapeutic Hypothermia|Therapeutic hypothermia involves use of a servo-controlled device and blanket to lower the core body temperature by 3°C for 72 hours followed by a period of re-warming in which the temperature is increased by 0.5°C per hour for 6 hours until normothermia is achieved.
15833514|NCT04176471|Other|Normothermia|Normothermia will be achieved using the same servo-controlled device and blanket to assure normothermia of the control arm. The goal temperature for normothermia is 36.5-37.3°C for 72 hours.
15833515|NCT04176458|Device|Methacetin Breath Test (MBT)|The hypothesis is that MBT CPDR 20 in the Fontan patient is abnormal as a result of alterations in liver perfusion, liver cell metabolic capability and transhepatic resistance secondary to hemodynamics unique to the Fontan as well as end-organ liver damage. Due to lack of robust biomarkers or other risk stratification schemes, we aim to determine whether there is prognostic value in hepatic MBT CPDR 20 in the Fontan patient.
15833516|NCT04176445|Device|Orthostatic board posture|Patients will be verticalized at at 45º, 60º and 80º using an orthostatic board. The total posture protocol will last 30 minutes
15833517|NCT04176445|Other|Bedside sitting posture|Patients will be placed at the bedside, with support for the back and upper limbs. They will be kept at 90º of hip and knee flexion and feet supported. The total posture protocol will last 30 minutes.
15833518|NCT04176432|Other|No intervention|Retrospective observational study with no intervention
15833519|NCT04176419|Drug|Ketamine|0.25 mg/kg IV bolus before incision, followed by 0.005 mg/kg/minute IV for the remainder of the surgical case excluding the final 30-45 minutes.
15833520|NCT04176419|Drug|Placebo Ketamine|0.25 mg/kg IV bolus before incision, followed by 0.005 mg/kg/minute IV for the remainder of the surgical case excluding the final 30-45 minutes.
15833521|NCT04176419|Drug|Lidocaine|1.5 mg/kg IV bolus before incision, followed by infusion of 1.5 mg/kg/hour ideal body weight (max 8 hours) during the case
15833522|NCT04176419|Drug|Placebo Lidocaine|1.5 mg/kg IV bolus before incision, followed by infusion of 1.5 mg/kg/hour ideal body weight (max 8 hours) during the case
15833523|NCT04176419|Drug|Acetaminophen|1,000 mg orally at time of check-in to the preoperative unit
15833524|NCT04176419|Drug|Placebo Acetaminophen|1,000 mg orally at time of check-in to the preoperative unit
15833525|NCT04176419|Drug|Gabapentin|600 mg orally at time of check in to the preoperative unit
15833526|NCT04176419|Drug|Placebo Gabapentin|600 mg orally at time of check in to the preoperative unit
15833527|NCT04176419|Drug|Celecoxib|200 mg orally at time of check in to the preoperative unit
15833528|NCT04176419|Drug|Placebo Celecoxib|200 mg orally at time of check in to the preoperative unit
15833529|NCT04176406|Device|rTMS|excitatory 5Hz rTMS will be used
15833530|NCT04176406|Device|Sham rTMS|an electrical sham coil reproducing the same clicking sound and tactile sensation than the active rTMS will be used
15833531|NCT04176393|Drug|ivosidenib|subjects will receive a single dose of ivosidenib 500 mg on Day -3 (i.e., 3 days prior to the start of daily dosing) and undergo PK/PD assessments over 72 hours to evaluate drug concentrations and 2-HG levels. Following that, subjects will be treated with ivosidenib 500 mg once a day (QD) PO continuously (28-day cycles, there are no inter-cycle rest periods).
15833532|NCT04176380|Biological|RAPA-201 Autologous T cells|Autologous rapamycin resistant Th1/Tc1 cells
15833533|NCT04176367|Drug|Nicergoline from China|This is the test arm of China local manufactured Nicergoline
15833534|NCT04176367|Drug|Nicergoline from Italy|This is the reference arm of Italy originator Nicergoline.
15833535|NCT04176354|Drug|Palbociclib + an aromatase inhibitor|Palbociclib + an aromatase inhibitor therapy
15833536|NCT04176354|Drug|Palbociclib + Letrozole|Palbociclib + Letrozole therapy
15833537|NCT04176354|Drug|Letrozole|Letrozole monotherapy
15833538|NCT04176341|Other|a systematic proposal for non pharmacological interventions targeting the subject's empowerment among slackline, mindfulness, adapted physical activity, self-hypnosis, and Qi Gong|chronic pain patient consulting in Grenoble Alps University Hospital, and Hospital Mutualist Group who will one non pharmacological intervention between slackline, mindfulness, adapted physical activity, self-hypnosis, Qi Gong during 6 to 8 weeks.
15833539|NCT04176328|Drug|Teicoplanin Sandoz 200 mg powder and solvent for solution for injection or infusion or oral solution.|Teicoplanin Sandoz administered by inhalation (aerosol).
15833540|NCT04176315|Other|Conventional Home-based Rehabilitation Plan|Usual intervention at Presidio Sanitario San Camillo for post-operative rehabilitation of THA patients. Participants receive inpatient care and rehabilitation for 2 weeks. At discharge, they receive a 5-exercise home-based rehabilitation plan. For the sake of homogeneity of all participants, they receive from 2 to 4 of training prior to discharge. At home, participants shall perform the exercises in the rehabilitation plan daily.
15833541|NCT04176315|Device|ReHub Home-based Rehabilitation Plan|"Combination of the usual intervention at Presidio Sanitario San Camillo for post-operative rehabilitation of THA patients with ReHub, a telerehabilitation platform that serves as a guide to perform the TKA rehabilitation exercises.
~Participants receive inpatient care and rehabilitation at San Camillo for 2 weeks. At discharge, a 5-exercise home-based rehabilitation plan is carried out by a site physiotherapist by using ReHub to acquire the participant's movement pattern with a wearable inertial sensor. Participants receive from 2 to 4 sessions of ReHub prior to discharge.
~At home, participants shall perform the exercises in the rehabilitation plan with ReHub daily. The wearable inertial sensor participants must wear tracks movement while they do the TKA rehabilitation exercises. Movement is analysed and feedback is given in real time. Participants can select if they have felt pain in a scale from 1 to 10. A physiotherapist monitors the participants' progress remotely."
15833874|NCT04173611|Drug|Bupivacaine Hydrochloride|Injection into the Intrathecal space.
15833543|NCT04176302|Diagnostic Test|Motor fluctuations diary|The neurologists will receive the patient's diary report (for medication adjustment, if any as per physician's criteria/judgement).
15833544|NCT04176302|Other|Traditional clinical practice|The neurologists will receive the patient & caregiver report at the time of the visit (for medication adjustment, if any as per physician's criteria/judgement).
15833545|NCT04176289|Diagnostic Test|PPI measurement|The pupillary dilatation reflex (PDR), induced by a standardized noxious stimulus will be measured as Pupillary Pain Index(PPI,11-point numeric scale, 0= no pain, 10= worst pain) determined with a portable pupillometer. Patients experiencing mild or more severe pain (PPI> 3) will receive intravenous opioid titration (piritramid, 3 mg bolus steps) and PPI measurement performed before and after intravenous opioid titration.
15833546|NCT04176276|Other|no interventions required.|The study does not require any interventions.
15833547|NCT04176263|Behavioral|SBT|The SBT group will receive a 4-week split-belt treadmill training, 3 times a week using a standardized progression protocol. The sessions, including breaks, will approximately take 1 hour each. The training will be given by a trainer experienced with PD.
15833548|NCT04176263|Behavioral|TBT|The TBT group will receive a 4-week tied-belt treadmill training, 3 times a week. To make sure exposure of the two interventions is similar the sessions of the TBT group will be of similar length and progression level (approximately 1 hour each). The training will be given by a trainer experienced with PD.
15833549|NCT04176250|Drug|TBA-7371|Participants will receive TBA-7371 oral suspension 100 milligram (mg) once daily (QD) for 14 days.
15833550|NCT04176250|Drug|TBA-7371|Participants will receive TBA-7371 oral suspension 100 mg twice daily (BID) for 14 days.
15833551|NCT04176250|Drug|TBA-7371|Participants will receive TBA-7371 oral suspension 200 mg QD for 14 days.
15833552|NCT04176250|Drug|TBA-7371|Participants will receive TBA-7371 oral suspension 100 mg three times daily (TID) for 14 days.
15833553|NCT04176250|Drug|TBA-7371|Participants will receive TBA-7371 oral suspension 400 mg QD for 14 days.
15833554|NCT04176250|Drug|HRZE|Participants will receive Isoniazid [H] / rifampicin [R] / pyrazinamide [Z] / ethambutol [E] (HRZE), a fixed dose combination (H: 75 mg / R: 150 mg / Z: 400 mg / E: 275 mg) tablet QD for 14 days.
15833555|NCT04176237|Other|UV Dosimetry Laboratory|The UV Dosimetry Laboratory is a one hour lesson that incorporates science and health education - kids hypothesize what UV levels will be around the school yard, go and measure UV, review their results, and then come up with a SunSmart plan for playing in the school yard.
15833556|NCT04176224|Drug|MT-1186|Suspension
15833558|NCT04176185|Biological|Sublingual allergy immunological tablet|For daily administration (1 tablet per day)
15833559|NCT04176185|Other|Placebo|For daily administration (1 tablet per day)
15833560|NCT04176172|Drug|Varenicline|Participants will receive open-label varenicline for 12 weeks.
15833561|NCT04176172|Drug|Nicotine patch|Participants will receive open-label nicotine patch for 12 weeks. (Participants in the NMR-tailored treatment arms will receive either varenicline OR patch; they will not receive both)
15833562|NCT04176172|Behavioral|Standard treatment|Standard behavioral smoking cessation treatment is an effective treatment for nicotine dependence. Treatment focuses on self-monitoring of smoking behavior, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, and relapse prevention. Participants will receive up to 5 therapy sessions (2 in person, 3 over the phone) over 8 weeks.
15833563|NCT04176172|Behavioral|Standard treatment + Managed Problem Solving (MAPS) adherence intervention|Standard behavioral smoking cessation treatment is an effective treatment for nicotine dependence. Treatment focuses on self-monitoring of smoking behavior, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, and relapse prevention. Managed Problem Solving (MAPS) is a therapeutic process that involves the systematic delineation of a participant's medication adherence problems and construction of a series of individualized solutions that therapists and participants explore together. Participants will receive up to 5 therapy sessions (2 in person, 3 over the phone) over 8 weeks. The first session will directly address potential medication adherence barriers, and therapist and participant will collaboratively brainstorm ways to overcome these barriers.
15833564|NCT04176159|Other|MOTOR IMAGERY AND TASK-ORIENTED TRAINING|"The intervention will be divided into two modules. A first module will include activities of activation and relaxation of the body, prediction and sequencing of movement and motor imagery. The second module, task-oriented training, will be divided into analytical work phase (visual coordination, balance, muscular strength, fine motor skills ...), a second phase of integration into specific tasks and, at end, the inclusion of the free (and supervised) practice of a sport.
~The investigators will apply 20 sessions of 40 minutes."
15833565|NCT04176146|Behavioral|Peer comparison and social norms messaging|This group will receive a letter noting that their organization has not implemented at least one common care delivery practice that a majority their peers have already implemented. The letter will also note the percentage of peer organizations that have implemented the practice. This is done using peer comparison data and social norms messaging.
15833566|NCT04176133|Drug|Entolimod|Single dose administration of Entolimod
15833567|NCT04176133|Drug|Placebo|Single dose administration, no active ingredient
15833568|NCT04176120|Biological|TTAX01|TTAX01 is a cryopreserved human umbilical cord product derived from donated human placental tissue following healthy, live, caesarian section, full-term births after determination of donor eligibility and placenta suitability. TTAX01 is manufactured by TissueTech Inc. utilizing a proprietary CRYOTEK® process, which devitalizes the living cells but retains the natural structural and biological characteristics relevant to this tissue. TTAX01 is aseptically processed in compliance with current Good Tissue Practices (cGTP). TTAX01 will be manufactured in various sizes, stored in a medium of lactated Ringer's/glycerol (1:1).
15833662|NCT04175379|Other|group 40|During surgery, the TV(tidal volume) should maintain 6ml/kg (ideal body weight). After position change and OLV(one lung ventilation) for operation, each patient adjusts RR(respiratory rate) to reach target PaCO2 40 ± 5mmHg. Hemodynamic records and arterial blood tests are performed at the following times: After tracheal intubation, 15 minutes after in two lung ventilatory state at the supine position (T0), after 30 minutes reaching to the target PaCO2 by adjusting RR at the lateral position starting one lung ventilation (T1), and after 60 minutes while maintaining target PaCO2 (T2).
15833875|NCT04173611|Other|Placebo|Injection into the Intrathecal space.
15833569|NCT04176120|Other|Standard Care|"Standard care is defined in this protocol to consist of the following:
~Debridement;
~Wound cleansing, using sterile saline, a non-ionic cleanser or a hypochlorous solution. Antiseptic agents including hydrogen peroxide, acetic acid, chlorhexidine, povidone/iodine, and cetrimide should not be used. Topical antimicrobials and silver dressings are also prohibited;
~Primary wound dressings including a non-adherent, standard foam pad with or without a hydrogel beneath the dressing, or and alginate dressing, as is appropriate to maintain a moist wound environment while managing exudate;
~A secondary retention bandage appropriate to the amount of wound exudate, so as to avoid maceration of the peri-wound skin;
~Off-loading device appropriate to the location of wound with full length boot or total contact cast (unless not appropriate where a substitute off-loading device can be made with sponsor approval); and,
~Appropriate use of systemic antibiotics."
15833570|NCT04176107|Behavioral|Informative video|Exposure to informative video before cesarean delivery
15833571|NCT04176094|Other|16h overnight duty|schedule observed by participating ICUs.
15833572|NCT04176094|Other|24h overnight duty|schedule observed by participating ICUs.
15833573|NCT04176094|Other|Handover training|Formal handover training for residents in both interventions. ICUs with a pre-existing standardized handover training and process will be asked to continue handover practices throughout the study. In ICUs without a pre-existing standardized handover training and process, ICU education directors will be provided with materials to include in orientation of residents to the ICU and local training to ICU staff physicians at least once per year.
15833574|NCT04176081|Drug|Darolutamide|Darolutamide will be administered orally as a tablet. Total daily dose is 1200 mg (2 tablets of 300 mg taken twice daily) for 6 months.
15833575|NCT04176081|Drug|Degarelix|Degarelix is administered by subcutaneous injection. The first dose of degarelix is 240 mg followed by monthly doses of 80 mg for a total treatment duration of 6 months.
15833576|NCT04176081|Radiation|Radiation Therapy|The total radiotherapy dose for all subjects will be: 36.25 Gy in 5Fx. The study will not include elective nodal irradiation. Every fraction will have 3D image guidance (i.e. cone-beam CT).
15833577|NCT04176068|Combination Product|calcium hydroxylapatite (Radiesse) and IFUS (Ulthera)|Patients will receive IFUS to a randomly chosen side. Immediately after IFUS treatment, patients will receive the first CaHA injection. Injections will be given in the lower, anterior third of the thigh, above the knee. Only dermatology faculty will perform the filler injections. The patients will be instructed to return to the office in 6 weeks, 12 weeks, and 24 weeks (+/- 5 business days) for their next appointment for follow-up and injection of CaHA if deemed necessary by the investigator. At all visits (Visits 1-4) patients will have photographs and unblinded physician/patient questionnaires will be completed. At Visit 4 (24 weeks +/- 5 business days), patients will be given the option to receive treatment for skin laxity to the previously untreated side. If the patient chooses to receive treatment, patients will receive their second IFUS and CaHA combination treatment at this time. They will not receive further treatment after this visit.
15833578|NCT04176055|Drug|Haloperidol|haloperidol intervention
15833579|NCT04176042|Behavioral|Track 1|Intervention + Follow-up
15833580|NCT04176042|Behavioral|Track 2|Wait list + Intervention
15833581|NCT04176029|Device|lung ultrasound|Lung ultrasound is performed using an 12-regions technique i.e. six areas on each side of the chest, two ventral, two lateral and two posterior. The lung ultrasound examination is estimated to take around 10 minutes of time.
15833582|NCT04176016|Drug|OTSA101-DTPA-111In|single IV injection, 185MBq/body
15833583|NCT04176016|Drug|OTSA101-DTPA-90Y|IV injection (max. 3 injections per patient), 1110MBq/body
15833584|NCT04176003|Other|Qualitative interview|Qualitative interview to explore experiences and perceptions of living with CPPD, and outcome measures to use in future studies
15833585|NCT04176003|Other|Member checking|Participants will be sent a short report with the researchers' findings from the qualitative interview, and asked to check the accuracy of these and provide brief written feedback.
15833586|NCT04175990|Drug|Dydrogesterone Pill|started from day 1 of menses till trigger day
15833587|NCT04175977|Behavioral|Aliviado Dementia Care-Hospice Edition QAPI program|PWD will receive care from a care team who has received the Aliviado Dementia Care-Hospice Edition QAPI program training.
15833588|NCT04175977|Behavioral|Control|PWD subjects will receive usual care as provided by their hospice agency
15833589|NCT04175964|Behavioral|ketogenic diet|The ketogenic diet will be designed according to the BMI for each participant by a consultant nutritionist. All participants will be prescribed this diet for 8 weeks.
15833590|NCT04175964|Combination Product|caloric diet with Metformin|The caloric diet will be designed according to the BMI for each participant by a consultant nutritionist. All participants will be prescribed this diet with Metformin for 8 weeks.
15833591|NCT04175964|Behavioral|caloric diet|The caloric diet will be designed according to the BMI for each participant by a consultant nutritionist. All participants will be prescribed this diet for 8 weeks.
15833592|NCT04175951|Device|Intraocular lens|Tecnis Eyhance is a monofocal IOL which give added intermediate vision without employing EDOF or multifocal technology and hence induces no glare and halos. Whereas monofocal IOLs such as RayOne do not give intermediate vision.
15833593|NCT04175938|Device|Wearing of contact lens|All subjects will wear a contact lens for three hours. The effect of the lens on the eye (epithelial swelling) will be measured at intervals after the lens is removed.
15833594|NCT04175925|Drug|BMS-986322|Specified Dose on Specified Days
15833595|NCT04175925|Other|BMS-986322 Placebo|Specified Dose on Specified Days
15833596|NCT04175925|Drug|famotidine|Specified Dose on Specified Days
15833663|NCT04175379|Other|group 50|During surgery, the TV(tidal volume) should maintain 6ml/kg (ideal body weight). After position change and OLV(one lung ventilation) for operation, each patient adjusts RR(respiratory rate) to reach target PaCO2 50 ± 5mmHg. Hemodynamic records and arterial blood tests are performed at the following times: After tracheal intubation, 15 minutes after in two lung ventilatory state at the supine position (T0), after 30 minutes reaching to the target PaCO2 by adjusting RR at the lateral position starting one lung ventilation (T1), and after 60 minutes while maintaining target PaCO2 (T2).
15833871|NCT04173624|Diagnostic Test|Endosonography|Endosonography (EUS) is endoscopic method for evaluated pancreatic and biliary pathology.
15833600|NCT04175899|Other|Pharmacist-led Oral Chemo Care Program (POCCP)|"Structured intensified pharmaceutical care program for patients ongoing oral chemotherapy treatment.
~Led by oncology experienced clinical pharmacist and run alongside oncologist patient review at the clinic or daycare.
~It utilizes structured educational material (for patients) and monitoring guideline or checklists (for pharmacists) during provision of service at each clinic visit such as patient education, pre-treatment review, medication reconciliation, prescription screening (dose, regime, supportive meds), adherence, adverse drug event monitoring and treatment recommendations on basis of agreed protocols.
~Pharmacist scheduled additional review within 1-week interval of start of oral chemotherapy at clinic or via phone call (according to patient's preference) will also be conducted to review patients taking their oral medications at home, assess adherence and symptom experienced to provide individualized recommendations or support to patients."
15833601|NCT04175886|Drug|Tofacitinib|Patients will be treated with tofacitinib
15833602|NCT04175873|Other|music|Patients will listen to music with MP3 headphones for 1 hour preoperatively and throughout the operation.
15833603|NCT04175860|Behavioral|The intervention with the patient (Chronic Patient Care Group and his family.)|"Characterization: through the application of the characterization survey of the dyad (patient-caregiver),
~Evaluation of the competence to care at home: Application of the instrument 'competence to care at home, long and short version both the patient and the family caregiver.
~Risk assessment: this step is made based on the complexity of the treatment and the results of the evaluation the competence to care at home."
15833604|NCT04175847|Drug|RC88|Participants will be allocated to one of the following dose groups: 0.1, 0.5, 1.0, 1.5, 2.0 and 2.5 mg/kg, and receive a treatment of RC88-ADC followed by 21 days of dose limited toxicity (DLT) observation period.
15833605|NCT04175834|Drug|antihistamine|prophylaxis
15833606|NCT04175821|Radiation|Hypofractionated radiotherapy|35Gy/ 15#/3weeks to chest wall and 40Gy/15#/3 weeks to supraclavicular fossa
15833607|NCT04175808|Drug|Omecamtiv Mecarbil (OM)|Oral solution
15833608|NCT04175808|Drug|Placebo|Placebo oral solution
15833609|NCT04175808|Drug|Moxifloxacin|400 mg moxifloxacin oral tablet
15833610|NCT04175795|Behavioral|My Personal Brain Health Dashboard|"The intervention of this study is grounded in the knowledge-to-action framework (Graham et al., 2006) and consists of providing feedback by sending participants their personalized health outcome profiles. As mentioned above, the context of our study is the BHN cohort. For all participants enrolled in the parent study, data on wide spectrum of health outcomes have been gathered. As part of the knowledge translation plan, a personalized profile of specific modifiable health outcomes called as My Personalized Brain Health Profile has been created for each participant (Appendix B). The profile covers information on brain health outcomes, health and quality of life ratings, and lifestyle factors."
15833611|NCT04175782|Procedure|Enhanced recovery after surgery (ERAS) protocol|"Preoperative:
~Counseling before hospital admission Fluid, and carbohydrate loading Avoiding prolongation of the fasting period Avoiding bowel preparation or its application only in selective cases Application of antibiotic prophylaxis Application of thromboprophylaxis Avoiding premedication
~Intraoperative:
~Use of short-acting anesthetic agents Refraining from using drains Refraining from salt, and water overload Maintenance of normothermia (heating the body, and use of warmed up intravenous fluids)
~Postoperative:
~Refraining from the use of nasogastric tube Prevention of nausea, and vomiting Refraining from salt, and water overload Earlier removal of catheters Initiation of oral intake at an early period Use of nonopioid oral analgesics/NSAIDs Early mobilization Adherence to the protocol, and auditing results"
15833612|NCT04175769|Dietary Supplement|Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)|"Subjects will be advised to orally consume two gelatin capsules (1 gram), 2 times per day with meals, totaling four capsules per day beginning the first day of treatment and continuing for the duration of their treatment.
~Each capsule will contain the study product (500 mg of EPA + 200 mg of DHA)."
15833613|NCT04175769|Other|Placebo|"Subjects will be advised to orally consume two gelatin capsules (1 gram), 2 times per day with meals, totaling four capsules per day beginning the first day of treatment and continuing for the duration of their treatment.
~Each capsule will contain 1 g of sunflower oil."
15833614|NCT04175756|Device|Caiman 5 articulating Maryland|Laparoscopic colorectal surgery
15833615|NCT04175743|Drug|CT-044 HCl|CT-044 HCl is a reactive species decomposition accelerant
15833616|NCT04175730|Device|Ultrasound and MRI|A single subsequent ultrasound guided prostate biopsy with MRI fusion
15833617|NCT04175730|Device|Ultrasound|A single subsequent ultrasound guided prostate biopsy
15833618|NCT04175717|Other|physiotherapy-led follow-up programme|In this study arm, the participants will receive a nine weeks exercise programme and four education sessions. During the exercise programme, the patients will exercise twice per week under supervision and once by themselves. The supervised exercise sessions will consisted out of a combination of a cardiopulmonary and strength training and the unsupervised session will be an activity, which the participants like doing. Additionally, when the patient shows a reduced maximal inspiratory pressure (indication for a reduced diaphragm strength), the patient will also be ask to do an inspiratory muscle training at home. Furthermore, they will participate in education sessions, where they learn things about the intensive care unit, the post-intensive care syndrome, relaxation techniques and how to carry on with exercising.
15833619|NCT04175704|Drug|UB-221|Name: UB-221 Active ingredient: Anti-IgE monoclonal antibody Dosage form: UB-221 drug product is presented as a sterile liquid for intravenous (IV) infusion. Each vial contains 75 mg/mL UB-221 in 1.12 mL of buffered solution
15833620|NCT04175691|Genetic|Sequencing of circRNA/miRNA/lncRNA|Next generation sequencing of circular RNA (circRNA), micro-RNA (miRNA) and long non-coding RNA (lncRNA)
15833621|NCT04175678|Other|Diet|Participants will receive delivered meals every 4 weeks for three months of a variety of foods for breakfast, lunch, dinner, two snacks, and an additional snack or dessert for each day.
15833622|NCT04175678|Other|Exercise|Training will be supervised, individualized, and periodized, incorporating 3 sessions per week, 45-60 min per session for 36 sessions.
15833623|NCT04175665|Drug|Semaglutide|Prescription for semaglutide as part of usual clinical practice
15833747|NCT04174612|Drug|Midostaurin|50 mg/bid day 8-21
15833748|NCT04174612|Drug|Cytarabine HD|100 mg/m2/bid day 1-3 100 mg/m2/die day 4 1.500 mg bid day 5-7
15833749|NCT04174599|Biological|F-627|Recombinant Human Granulocyte Colony Stimulating Factor-Fc Fusion Protein
15833750|NCT04174586|Biological|microtransplantation|HLA mismatched donor cord blood infusion
15833624|NCT04175652|Behavioral|Laughter yoga|The laughter yoga practice was initiated through clapping and warm-up exercises: hands were clapped keeping hands in parallel with each other and ensuring that the fingertips touched each other. To increase the energy level of the group, a rhythmic beat was added to the clapping in the form of 1-2, 1-2-3. While this was being sung a rhythm was tapped out on the floor by moving the feet up and down. Eye contact was constantly maintained with the participants. In the second phase, deep breathing exercises were performed. Participants were encouraged to inhale from the diaphragm. Individuals were asked to put their hands on their belly and inhale through the nose and then slowly exhale through the mouth. After the deep breathing exercise, the participants were encouraged to laugh through playing children's games in the third phase.
15833625|NCT04175639|Behavioral|Mobile Health Pain Coping Skills Training (mPCST)|Participating in Mobile Health Pain Coping Skills Training will involve four 50-minute individual intervention sessions conducted over the course of 8 weeks with tele-video-conferencing at patient's community-based clinic. The therapist delivering the intervention will be at Duke University Medical Center, and patients will be at their community clinic.
15833626|NCT04175626|Device|Orsiro DES|Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
15833627|NCT04175613|Drug|Apremilast|Apremilast dose will be increased from 20 mg BID to 30 mg BID for those subjects that reach a weight of 50 kg or more during the study
15833630|NCT04175587|Drug|Compound Realgar-Indigo Naturalis Formula Plus Retinoic Acid|Randomization is done centrally according to trial centers Eligible patients are randomly assigned (2:1) to the Treatment Group or the Control Group, with a 24-month follow-up.
15833631|NCT04175574|Other|Music|The music has no lyrics, has a sustained melodic quality, has no strong rhythms and percussion or base, rate of 60-80 beats per minute, promotes relaxation, calming and soothing, neutral and is unbiased towards any culture or age. The volume of the music will be pre-adjusted to the patients' preference (preferable 30 dB) by the research assistant.
15833632|NCT04175561|Other|Green prescription|Green prescription intervention will include horticultural activities such as planting, harvesting, learning about ecology and sustainable food growing.
15833633|NCT04175548|Other|Data extraction from medical files|Data extraction from medical files
15833634|NCT04175535|Procedure|Percutaneous Posterior Endoscopic Cervical Discectomy|The most common alternative in the case of soft cervical disc herniations.
15833635|NCT04175535|Procedure|Anterior cervical decompression and fusion|The standard procedure for operation of cervical disc herniations.
15833636|NCT04175522|Drug|Immunoglobulin G|IGIV 10%(400mg/kg) QD for 5 consecutive days administrated intravenously.
15833637|NCT04175509|Drug|Rectal acetaminophen|Rectal 1300mg
15833638|NCT04175509|Drug|Intravenous acetaminophen|Intravenous 1000mg
15833639|NCT04175496|Other|Blueberry Cake|Blueberry cake containing 25 g available CHO will be served to the participants after 10-hours fasting and asked to consume it within 15 minutes, along with 250 ml of water. Taking the first bite from test food will be considered as 0 min. Blood samples will be collected at time points 0,15, 30, 45, 60, 90 and 120 min.
15833640|NCT04175496|Other|Snacks with Cheese|Snacks with cheese containing 25 g available CHO will be served to the participants after 10-hours fasting and asked to consume it within 15 minutes, along with 250 ml of water. Taking the first bite from test food will be considered as 0 min. Blood samples will be collected at time points 0,15, 30, 45, 60, 90 and 120 min.
15833641|NCT04175496|Other|Spicy Crackers|Spicy crackers containing 25 g available CHO will be served to the participants after 10-hours fasting and asked to consume it within 15 minutes, along with 250 ml of water. Taking the first bite from test food will be considered as 0 min. Blood samples will be collected at time points 0,15, 30, 45, 60, 90 and 120 min.
15833642|NCT04175496|Other|Glucose Solution First Repeat|The glucose solution will be prepared by dissolving 25 g of glucose in 250 ml of water. Participants consume the glucose solution within 15 minutes after 10-hours fasting. Blood samples will be collect at time points 0,15, 30, 45, 60, 90 and 120 min.
15833643|NCT04175496|Other|Glucose Solution Second Repeat|The glucose solution will be prepared by dissolving 25 g of glucose in 250 ml of water. Participants consume the glucose solution within 15 minutes after 10-hours fasting. Blood samples will be collect at time points 0,15, 30, 45, 60, 90 and 120 min.
15833644|NCT04175483|Other|assessment of subglottic diameter by ultrasonography|assessment of subglottic diameter by ultrasonography
15833645|NCT04175470|Drug|Bevacizumab|10 mg/kg intravenously every three weeks
15833646|NCT04175470|Dietary Supplement|Tocotrienol|Capsules, 300 mg orally three times daily
15833647|NCT04175457|Other|e-cigarette|E-cigarette inhalation for 30 minutes using e-cigarette with and without nicotine
15833648|NCT04175444|Diagnostic Test|VisuALL Field Analyzer|Each participant will conduct a visual field test with the visuaALL headset.
15833649|NCT04175444|Diagnostic Test|Humphrey Field Analyzer|Each participant will conduct a standard of care Humphrey Visual Field.
15833650|NCT04175431|Procedure|Positron Emission Tomography|Undergo fluciclovine PET/CT
15833651|NCT04175431|Procedure|Lymphadenectomy|Undergo lymphadenectomy
15833652|NCT04175431|Radiation|Radiation Therapy|Undergo radiation therapy
15833653|NCT04175431|Drug|Abiraterone Acetate|Given PO
15833654|NCT04175431|Drug|Prednisone|Given PO
15833655|NCT04175431|Procedure|Computed Tomography|Undergo fluciclovine PET/CT
15833656|NCT04175431|Drug|Abiraterone|Given PO
15833657|NCT04175418|Other|Supervised Exercise Program|The exercise program in this group includes aerobic (walking) training and exercises to strengthen the upper and lower extremities and trunk muscles.
15833658|NCT04175418|Other|Online Education Program|The exercise program in this group includes aerobic (walking) training and home exercises to strengthen the upper and lower extremities and trunk muscles.
15833659|NCT04175405|Procedure|Irradiation of implants with 635nm laser|Irradiation of implants with 635nm laser with a dose of 10J
15833660|NCT04175392|Drug|Align Probiotic Supplement Capsule|Align Probiotic 1 billion units, 1 capsule once daily
15833661|NCT04175392|Drug|Placebos|Placebos capsule 1 capsule Once daily
15833664|NCT04175379|Other|group 60|During surgery, the TV(tidal volume) should maintain 6ml/kg (ideal body weight). After position change and OLV(one lung ventilation) for operation, each patient adjusts RR(respiratory rate) to reach target PaCO2 60 ± 5mmHg. Hemodynamic records and arterial blood tests are performed at the following times: After tracheal intubation, 15 minutes after in two lung ventilatory state at the supine position (T0), after 30 minutes reaching to the target PaCO2 by adjusting RR at the lateral position starting one lung ventilation (T1), and after 60 minutes while maintaining target PaCO2 (T2).
15833665|NCT04175366|Other|Shared Decision Making|Shared Decision Making including adapted decision aid.
15833666|NCT04175353|Dietary Supplement|Dairy snack|The effects of dairy snack are compared with orange juice.
15833667|NCT04175353|Dietary Supplement|Berry snack|The effects of two berry snacks are compared with berry soup.
15833668|NCT04175327|Device|CardioCel implantation|treatment of intracardiac defects; treatment of septal defects; valve and annulus repair; great vessel reconstruction; peripheral vascular reconstruction; suture line buttressing
15833669|NCT04175314|Other|Clinical examination of gingival tissues|Measure of the periodontal recession
15833670|NCT04175301|Drug|Hydrogen|Each hydrogen tablet contains 80 mg magnesium
15833671|NCT04175301|Drug|Placebo oral tablet|Matching placebo tablet also contains 80 mg magnesium
15833672|NCT04175288|Other|Ultrasound, manual therapy and exercise|The experimental group will receive ultrasound (US) for 3 sessions a week for 4 weeks, with continuous US (1.8 w/cm2, 1 Mega Hz 8 minutes). Manual therapy will include posterior glides to talocrural joint, subtalar lateral glide, a 1st tarsometatarsal joint dorsal glide and extension mobilization to the 1st metatarsophalangeal joint. All participants in each group will be given specific exercises by the investgators targeting intrinsic and extrinsic muscles of the foot and ankle. Specific stretches for the plantar fascia and Achilles tendon, will be performed. Home exercises will be recorded using a log.
15833673|NCT04175275|Other|Interview patient|Interview patient without scoring about the reasons for the implant, the complications, the reasons for abandonment, the evaluation of the satisfaction
15833674|NCT04175262|Drug|sunitinib|Patients to receive sunitinib as second line therapy for mRCC
15833675|NCT04175249|Other|Pizza meal challenge|Vegetarian pizza containing 10 grams of salt
15833676|NCT04175223|Dietary Supplement|Vivomixx|probiotic administration: administration of two sachets per day (one in the morning and one in the evening) during 6 months
15833677|NCT04175210|Radiation|Radiation therapy - 3 weeks|Patients randomized to ARM 1 will receive whole breast radiotherapy of 4050cGY and a concomitant boost to the tumor bed of 4800cGY in 15 fractions
15833678|NCT04175210|Radiation|Radiation therapy - 2 weeks|Patients randomized to ARM 2 will receive whole breast radiotherapy of 3200cGY and a concomitant boost to the tumor bed of 4200cGY in 10 fractions.
15833679|NCT04175197|Device|Drug Coated Balloon|Legflow Drug Coated Balloon
15833682|NCT04175171|Drug|Coprelotamab Injection|The single intravenous infusion of 8mg/kg Coprelotamab shall be administered within 90 minutes through infusion pump.
15833683|NCT04175171|Drug|Trastuzumab Injection|The single intravenous infusion of 8mg/kgTrastuzumab shall be administered within 90 minutes through infusion pump.
15833684|NCT04175158|Biological|GB222|Recombinant humanized antivascular endothelial growth factor monoclonal antibody injection Injection; strength 100mg/4ml/bottle; intravenous drip; a total of one administration, dosage 1mg/kg; The 2.5ml syringe is used to collect required volume of the drug, and then it will be added to 250 ml of 0.9% sodium chloride solution. The infusion bag should be gently inverted to prevent air bubbles. If the required volume is > 2.5 ml, it should be collected twice, 2.5ml for the first time and the rest for the second time.
15833685|NCT04175158|Biological|Bevacizumab|Injection; strength 100mg/4ml/bottle; intravenous drip; a total of one administration, dosage 1mg/kg; The 2.5ml syringe is used to collect required volume of the drug, and then it will be added to 250 ml of 0.9% sodium chloride solution. The infusion bag should be gently inverted to prevent air bubbles. If the required volume is > 2.5 ml, it should be collected twice, 2.5ml for the first time and the rest for the second time.
15833686|NCT04175145|Other|Posterior spinal instrumentation|A fusion construct consisting of all pedicle screws except at uppermost instrumented vertebra. Contoured dual 6-mm stainless steel rods were used to connect the construct. Pedicle screw location and density was determined by the surgeon based on perceived curve stiffness and fusion length with an even distribution of fixation points along the construct. Pedicle screw instrumentation was performed by the free hand technique with biplanar fluoroscopic and direct screw EMG impedance testing for confirmation of placement. Reduction was via cantilever-segmental-translation maneuver in all cases.
15833687|NCT04175132|Drug|foliglurax|Capsules of 20/80 mg foliglurax, orally. Single doses of 20-240 mg
15833688|NCT04175132|Drug|foliglurax|Capsules of 20/80 mg foliglurax, orally. Single doses of 20-160 mg
15833908|NCT04173364|Drug|Ropivacaine 0.1% Injectable Solution|Dilution of ropivacaine to the concentration of 0.1%
15833689|NCT04175119|Device|Visual attention/perception tasks in healthy participants|The participants complete visual attention and perception tasks while fMRI, EEG, and MEG record brain signals. The tasks acquire responses with a visual saccade or button presses which are coupled to brain responses. These responses are then analyzed to identify patterns of communication between brain areas (within-subject). The flickering stimuli (experiment 1) may alter oscillations in the brain, while participants complete visual attention and perception tasks, leading to a secondary outcome measure distinct from the button presses. The procedure concerning the flickers will be the same for participants. The tACS (experiment 2, 3) delivers input in addition to gathering output while participants complete visual attention and perception tasks. A sinusoidal current at a chosen frequency interacts with the brain's natural oscillations and alters responses. Participants will have sham sessions of tACS as well (there is no group division), The sham will be compared with the stimulation
15833690|NCT04175106|Other|a non-traditional (i.e., not typically available in the supermarket) blueberry cultivar bred using natural plant breeding techniques and established as having enhanced nutritive value|"150 g of a non-traditional (i.e., not typically available in the supermarket) blueberry cultivar bred using natural plant breeding techniques and established as having enhanced nutritive value.
~Dietary restrictions will be observed (i.e. avoidance of food or supplements containing berry phytonutrients) for 7 days before each arm visit and throughout the study days."
15833691|NCT04175106|Other|a standard commercially available blueberry variety (i.e., cultivar)|"150 g of a standard commercially available blueberry variety (i.e., cultivar).
~Dietary restrictions will be observed (i.e. avoidance of food or supplements containing berry phytonutrients) for 7 days before each arm visit and throughout the study days."
15833692|NCT04175106|Other|"a minimally processed blueberry-rich protein bar"|"A minimally processed blueberry-rich protein bar matched to the phytonutrient content of the 150 g of the non-traditional blueberry.
~Dietary restrictions will be observed (i.e. avoidance of food or supplements containing berry phytonutrients) for 7 days before each arm visit and throughout the study days."
15833693|NCT04175106|Other|a control beverage of matched-nutritive content|"The matched nutritive content of the blueberry-rich protein bar will be dissolved in whey protein
~Dietary restrictions will be observed (i.e. avoidance of food or supplements containing berry phytonutrients) for 7 days before each arm visit and throughout the study days."
15833694|NCT04175093|Diagnostic Test|asymmetric dimethylarginine|measurement by ELISA of asymmetric dimethylarginine
15833695|NCT04175067|Diagnostic Test|Disulphide(μmol/L)|Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry
15833696|NCT04175067|Diagnostic Test|Total Oxidant Capacity(μmolH2O2Equiv/L)|Aforementioned oxidative stress markers will be measured via Cobas c501(Roche Diagnostics, Indianapolis, IN, USA) used with sphectrophotometry
15833697|NCT04175054|Other|Body-weight supported treadmill training in a room cooled to 16°C|Exercise will be performed on a treadmill using an overhead harness for safety in a temperature controlled-room at 16°C with 1:1 supervision. The high intensity group will maintain vigorous intensity with a target workload >60% of heart rate reserve for 30 min (plus 5min warm up and 5min cool down) while the low-intensity group will walk at mild intensity (<40% heart rate reserve) for the same duration. Heart rate, blood pressure, and rating of perceived exertion will be recorded throughout to monitor for potential adverse events and to ensure that target training zone heart rates are maintained. The intervention is 3 times per week for 12 weeks, with a 3-month run-in observational period to confirm disease stability, and 3-month follow-up to determine the sustainability of effects.
15833698|NCT04175041|Device|Transcranial Direct Current Stimulation|In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
15833699|NCT04175028|Device|Transcranial Direct Current Stimulation|In tDCS, electrodes are applied on the scalp to transmit direct current at low current amplitudes.
15833700|NCT04175015|Other|Smartie© sweet/candy|one chocolate sweet/ chocolate candy
15833701|NCT04175002|Drug|utrogestan|oral uterogeston 200mg daily to achieve window of implantation from previous study
15833702|NCT04174989|Other|Plasma treated with ClearPlasma (Extra-corporeal plasma filtration device)|ClearPlasma is designed to specifically extract plasminogen, a protein that drives fibrinolysis, from up to 250 mL of plasma. ClearPlasma is a non-pyrogenic, sterile, single-use medical device that is indicated for use in conditions where massive bleeding situations exist.
15833703|NCT04174989|Other|Regular fresh-frozen plasma (not treated)|Regular fresh-frozen plasma (not treated)
15833704|NCT04174976|Procedure|wall hernia repair|Wall hernia repair with mesh
15833705|NCT04174963|Behavioral|eToke + TPsy|Combination of brief computerized intervention (eToke) with Information-Motivation-Behavior based text messages tailored to young adults in psychiatric treatment
15833706|NCT04174950|Other|Routine nursing care|routine perioperative nursing intervention, including intensive observation of vital signs, preoperative education, postoperative communication and instruction on diet. NPO after the dinner one day before operation. Patients are instructed to NPO 3 days after surgery and patients should stay on the bed for 3 days. Urinary catheter is always kept for 48 hours or more.
15833707|NCT04174950|Other|Perioperative Enhanced Recovery After Surgery (ERAS) Based Nursing Model|Establish ERAS nursing team and formulate ERAS nursing intervention. Nothing by mouth (NPO) 6 hours before operation and no water 4 hours before operation. Patients are given fluid food 24 hours after surgery. Urinary catheter is removed within 24 hours after surgery and encourage patient to mobile 24 hours after surgery. Give support to pain control and psychological support. Intensive observation of vital signs, preoperative education, postoperative communication and instruction on diet were also given to patients.
15833708|NCT04174937|Drug|Potentiator of antibiotics (PA)|Intervention is administered to patients in this Arm
15833709|NCT04174937|Other|Placebo PA|Intervention is administered to patients in this Arm
15833710|NCT04174924|Procedure|Phakic intraocular lens (pIOL) explantation|"Phakic intraocular lens (pIOL) explantation is a surgical procedure to remove the pIOL which needs to be done after cataract formation.
~Cataract extraction is a surgical procedure to remove a lens in the eye that has become cloudy over time, affecting vision in that eye."
15833711|NCT04174911|Drug|BOL-DP-o-08|BOL-DP-o-08 sublingual drops
15833712|NCT04174911|Drug|Placebo|sublingual drops
15833713|NCT04174898|Biological|human Mesenchymal Stem Cell (MSC) infusion therapy|Subjects will be infused with 100million human MSCs
15833714|NCT04174885|Procedure|epicardial ablation|"In general anesthesia and left lung ventilation, authors will access the right thorax by three working ports. However, a rigid video thoracoscopic camera with a direct optics will be used. Pericardium will be widely opened anterior to a phrenic nerve and transverse and oblique sinuses were dissected. An insertion of the ablation catheter will be a tricky part of the surgery with the first MW catheter, while no special introducer will be provided. Later RF devices will be equipped with a special flexible introducers, lately also with a magnetic tip and the positioning of the catheter around PVs became much safer and easier.
~The correct position of catheter will be visualized by trans esophageal echocardiography before the ablation."
15833715|NCT04174872|Drug|Dexmedetomidine|it has a sedative effect without significant respiratory depression , anxiolytic, analgesic, antihypertensive and sympatholytic properties. It is now being used as a neuraxial adjuvant that can be used as an effective adjuvant in epidural anaesthesia as it intensifys the motor block and prolongs the duration of postoperative analgesia.
15833716|NCT04174872|Drug|Midazolam|Midazolam has been reported to have a spinally mediated analgesic effect. Clinically, single-shot epidural or spinal administration of midazolam has been shown to have an analgesic effect on perioperative pain.
15833718|NCT04174846|Dietary Supplement|Ready-to-use therapeutic food (RUTF)|SAM children will receive approximately 190 kcal/kg/day of standard RUTF
15833719|NCT04174846|Dietary Supplement|Ready-to-use-supplementary food (RUSF)|SAM children will receive approximately 190 kcal/kg/day of Acha Mum (AM-RUSF)
15833720|NCT04174820|Other|Functional Magnetic Resonance Imaging (fMRI)|list of the tests: Box and Blocks test, Nine Hole Peg test, walkway GAITRite, EXALang tests, NEPSY II subtests, BRIEF, FEE, WISC 5 tests
15833721|NCT04174794|Device|Lung ultrasound|The two different lung ultrasound protocols are performed initially within 48 hours of internal medicine ward admission by a pair of expert-beginner echographers. In case of admission during non-working days, the first scan can be done within 72 hours from admission. Follow-up scans are repeated 4 to 6 days later or on the day of discharge if it occurs before de fourth day. Experts and beginners execute the lund ultrasound protocols in sequence, reciprocally blinded, without accessing to clinical data files.
15833722|NCT04174781|Drug|Sintilimab Injection|Sintilimab therapy combined with standard TACE-DEB treatment
15833723|NCT04174781|Drug|TACE|TACE is performed by using drug eluting beads
15833724|NCT04174768|Procedure|Bariatric surgery|Bariatric surgery including sleeve gastrectomy and Roux-en-Y gastric bypass
15833725|NCT04174755|Drug|Semaglutide Injectable Product|Semaglutide 0.25 mg subcutaneously once weekly for 4 weeks, then Semaglutide 0.5 mg subcutaneously once weekly for 4 weeks, then Semaglutide 1 mg subcutaneously once weekly for 20 weeks. Total treatment duration 28 weeks.
15833726|NCT04174755|Behavioral|Standard of care|Diet and exercise advice for 40 weeks
15833727|NCT04174742|Drug|pegfilgrastim|It works by increasing neutrophil migration to counteract cytotoxicity. It is commonly administered to patients receiving chemotherapy for breast cancer treatment. It has been shown to significantly reduce the incidence of neutropenic fever, although without statistically significant impact on overall survival.
15833728|NCT04174729|Device|handgrip strength|First, the hand measurements of each volunteer were evaluated, followed by the measurement of handgrip strength using the Jamar® dynamometer. And later the tests were performed using the system that contains the 5 devices to quantify the hand strength.
15833729|NCT04174729|Device|Door handle device|To evaluate the cylindrical grip movement, a door handle was used, which evaluated the full force in the range of motion.
15833730|NCT04174729|Device|Tap device|To evaluate the spherical grip movement, a tap was used, which evaluated the full force in the range of motion.
15833731|NCT04174729|Device|Door pull handle|To assess the hook grip movement, a door pull handle was used, which assessed the full force in the range of motion
15833732|NCT04174729|Device|Linear Switch device|To evaluate the pulp-pulp pinch movement, a switch was used, which evaluated the full force in the movement of the movement.
15833733|NCT04174729|Device|Door Key device|To assess the pulp-side pinch movement, a door key was used, which evaluated the full force in the range of motion.
15833734|NCT04174716|Drug|IDX-1197|Until progression or unacceptable toxicity develops
15833735|NCT04174703|Other|Self-compassionate letter-writing intervention|Participants in this condition will be asked to engage in an online self-compassionate letter-writing task once per day (10-20 minutes each) for 2 weeks.
15833736|NCT04174690|Device|Force platform|In order to volunteers to be selected for collection a recruitment test will be taken, the volunteer will have to stand on one foot for 5 seconds without additional support. So that the volunteer can go to the balance test on the force platform, he will be dressed with safety equipment (harness), and will also have the attachment of the electrodes.
15833737|NCT04174677|Drug|Inebilizumab|Infusion of Inebilizumab
15833738|NCT04174677|Drug|VIB4920|Infusion of VIB4920
15833739|NCT04174677|Drug|Inebilzumab+VIB4920|Infusion of Inebilizumab and VIB4920
15833740|NCT04174664|Diagnostic Test|1-minute sit to stand test|Childrens will complete 1-minute sit to stand test and 3 minute step test and quality of life questionnaire.
15833743|NCT04174638|Other|Motivational Interviewing and Education Based on Watson's Theory of Human Caring|The intervention group received 15 minute motivational interviewing based on Watson's Theory of Human Caring once a month for 12 weeks and one session 30 minutes education with educational booklet based on Watson's Theory of Human Caring. The intervention performed before the hemodialysis session in a separate room in the hemodialysis unit.
15833744|NCT04174625|Dietary Supplement|Dietary Supplement: Omega3-FA|Dietary Supplement: Omega3-FA 300 mg of omega3-FA once daily for 8 weeks
15833745|NCT04174612|Drug|Cytarabine|100 mg/m2/bid day 1-3 100 mg/m2/die day 4-7
15833746|NCT04174612|Drug|Daunorubicin|60 mg/m2/die day 1-3
15833751|NCT04174573|Other|GTO|"Forward direction activity: Balance activity in forward direction on wooden balance board (5 reps X 3 sets X 2 days in a week, for 6 weeks)
~Backward direction activity: Balance activity in backward direction on wooden balance board (5 reps X 3 sets X 2 days in a week, for 6 weeks)
~Sideways direction activity: Balance activity in sideways direction on wooden balance board (5 reps X 3 sets X 2 days in a week, for 6 weeks)"
15833752|NCT04174573|Other|GT-tDCS|"Group therapy
~Forward direction activity: Balance activity in forward direction on wooden balance board (5 reps X 3 sets X 2 days in a week, for 6 weeks)
~Backward direction activity: Balance activity in backward direction on wooden balance board (5 reps X 3 sets X 2 days in a week, for 6 weeks)
~Sideways direction activity: Balance activity in sideways direction on wooden balance board (5 reps X 3 sets X 2 days in a week, for 6 weeks)
~tDCS Left anodal and right cathodal tDCS : Anode- F3, Cathode- Right Supra orbital area, Intensity- 2mA, Duration- 30 minutes, once in a week for 6 weeks"
15833753|NCT04174560|Biological|Norovirus GII.4 Challenge Pool|Subjects will be NPO (nothing by mouth) for at least 90 minutes followed by ingestion of 60 mL of a 2% sodium bicarbonate solution by mouth. 2 minutes later, subjects will be administered Norovirus GII.4 CIN-3. Five minutes following administration of the challenge dose, subjects will be administered a 60 mL volume of a 2% sodium bicarbonate solution and then remain NPO for at least the next 90 minutes. Subjects will be observed during the 60 minutes after receipt of the challenge by a study team member to detect and treat any immediate adverse reactions.
15833754|NCT04174495|Diagnostic Test|DXA and CT-scan|DXA and CT-scan are usually performed during the following of these patients before bariatric surgery
15833755|NCT04174482|Procedure|morphological and functional evaluation of adult flat foot|Evaluations are realized by weight bearing computed tomography and by Gait analysis in the pre-operative phase and at a 6-months follow-up from the surgery with Grice technique
15833756|NCT04174456|Diagnostic Test|FDG PET|baseline and 6-month follow-up FDG PET
15833757|NCT04174443|Procedure|High-voltage pulsed radiofrequency|2 Hz of pulsed radiofrequency will be administered at a voltage of 70 V, temperature of 42 °C, pulse width of 20 ms, and treatment time of 600 s.
15833758|NCT04174443|Procedure|Low-temperature continuous radiofrequency|Low-temperature continuous radiofrequency will be performed at 60 °C, with a treatment time of 270 s.
15833759|NCT04174430|Biological|severe bronchiolitis|Prematurity (gestational age ≤36 weeks), Low birth weight, Age less than 12 weeks,Chronic pulmonary disease, particularly bronchopulmonary dysplasia (also known as chronic lung disease), Anatomic defects of the airways, Hemodynamically significant congenital heart disease, Immunodeficiency, Neurologic disease
15833760|NCT04174417|Procedure|systolic blood pressure (SBP)|"Systolic blood pressure (SBP) 80-90 mmHg remifentanil infusion was applied to Group 1 patients. In addition to remifentanil infusion, 0.002 μg.kg of glycerol trinitrate (Perlinganit) was administered as an intermittent bolus in patients who needed to achieve target blood pressure. All patients received 5-8 ml / kg / h IV infusion of balanced electrolyte solution (Isolyte-S) during the operation.
~Hemodynamic parameters (HR, SBP, OCD), BIS, SpO2 and NIRS were recorded at 5 minute intervals. At the end of the operation, 3 ml of blood was taken from the untreated arm of all patients to the HIF1a, TAS and TOS values and sent to the biochemistry laboratory"
15833761|NCT04174417|Procedure|mean blood pressure (MBP)|"For group 2, remifentanil infusion was performed with a mean blood pressure (OCD) of 50-65 mmHg. In addition to remifentanil infusion, 0.002 μg.kg of glycerol trinitrate (Perlinganit) was administered as an intermittent bolus in patients who needed to achieve target blood pressure. All patients received 5-8 ml / kg / h IV infusion of balanced electrolyte solution (Isolyte-S) during the operation.
~Hemodynamic parameters (HR, SBP, OCD), BIS, SpO2 and NIRS were recorded at 5 minute intervals. At the end of the operation, 3 ml of blood was taken from the untreated arm of all patients to the HIF1a, TAS and TOS values and sent to the biochemistry laboratory."
15833762|NCT04174404|Other|ICory-Circumcision|The ICory-Circumcision is specially developed for this study based on preliminary studies, other literature, and most importantly, the surgical pathway currently practiced in the study hospital. The ICory-Circumcision programme has two components: (1) the Buddy Healthcare mobile app (BuddyCare) that provides a comprehensive day-by-day perioperative guide for parents regarding their child's surgery with an interface for health care professionals to monitor parents' and their children's needs as well as communicate with them. (2) The Triumf Health mobile game app that provides emotional support and distraction to children. The ICory-Circumcision programme is designed to be a self-guided and healthcare professional-led. Participants will have access to BuddyCare for parents and Triumf Health from time of recruitment till 2 weeks after surgery while the healthcare professional would receive face-to-face training on how to use the BuddyCare dashboard.
15833763|NCT04174404|Other|Routine care|The routine care consists of normal consultations with the doctor, preoperative preparation, and post-operative care. During the first consultation, the child will be assessed for the need for circumcision and the doctor explains verbally to the parents about the procedure, risks, what to expect and prepare pre-operatively.
15833764|NCT04174391|Behavioral|Mediterranean diet supplemented with extra-virgin olive oil|Dietary advice on how to follow a Mediterranean diet will be received by the intervention group. The intervention will be delivered mainly by phone (1 call/month), internet and written materials. Also, there will be yearly face-to-face individual interviews and biannual group sessions. A total of 0.5l/week of EVOO for free will be received by participants of this group. In addition, advice on physical activity will be provided.
15833765|NCT04174391|Behavioral|Low-fat diet|Dietary advice on how to follow a low-fat diet will be received by the intervention group. The intervention will be delivered mainly by phone (1 call/month), internet and written materials. Also, there will be yearly face-to-face individual interviews and biannual group sessions. Allotments of commercial foods - equivalent to the extra-virgin olive oil allotment - will be received by participants of this group for free. In addition, advice on physical activity will be provided.
15833766|NCT04174378|Drug|Decapeptyl 0.2mg|IM Decapeptyl o.2 mg was given 2 days before embryo transfer
15833767|NCT04174365|Drug|Brexpiprazole|Oral tablet; take once daily
15833768|NCT04174365|Drug|Placebo|No Intervention
15833769|NCT04174352|Drug|Tamoxifen|estrogen modulator
15833806|NCT04174079|Drug|chemotherapy|patients with R0 resected T≥3 or N≥1 thoracic esophageal squamous cell carcinoma began to receive chemotherapy of docetaxel combined with nedaplatin within 8 weeks after total two-field lymph node dissection. Docetaxel 75mg/m2 day 1, nedaplatin 75mg/m2 day 1, every 21 days for 4 cycles
15833807|NCT04174066|Other|blood sample|blood sample during planned in the follow-up of patients.
15833770|NCT04174352|Diagnostic Test|FES PET/CT|Radiolabeled estrogen [18F]-fluoroestradiol (FES) in combination with Positron Emission Tomography / Computed Tomography is a molecular imaging technique for measuring pharmacodynamic effects of endocrine therapy. The injected dose of 18F-FES will be 6 mCi (185 MBq) ± 20% with a specific activity greater than 170 Ci/mmol at the time of injection for an activity dose of 6 mCi. Participant will receive baseline imaging and repeat imaging after 3-4 weeks to evaluate for FES blockade as assigned dose level.
15833771|NCT04174339|Drug|Camrelizumab|Subjects receive SHR-1210 intravenously, Dosage form: lyophilised powder, Strength: 200 mg /vial，d1
15833772|NCT04174339|Drug|Apatinib Mesylate|Subjects receive Apatinib orally, Dosage form: tablet, Strength: 250 mg/tablet，TID
15833773|NCT04174339|Drug|POF|The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days.
15833774|NCT04174326|Behavioral|Immediate intervention group|Participants will be randomized to either the immediate or delayed intervention group at baseline. Participants in both groups will receive CBT for chronic pain management sequentially, once a week during the 6 week intervention period. Participants will be followed-up at 18 weeks from baseline. Two in-between sessions practice assignments will be added to each group therapy session during the the CBT program.
15833775|NCT04174313|Diagnostic Test|CT scan|"Mechanical variables and PaO2/FiO2 were registered daily for 14 days or until initiating assisted ventilation. These data were obtained in passive mechanical conditions.
~Ventilator-induced lung injury vortex was defined as a progressive increase in driving pressure (ΔP) as Vt remained constant or even decreased.
~Refractory hypoxemia was defined as PaO2/FiO2 <100 despite the optimization of mechanical ventilation and prone positioning."
15833776|NCT04174300|Procedure|Manual Therapy|8 sessions of manual therapy (twice weekly) of 25 minutes including pressure maneuvers of about 4,5 N
15833777|NCT04174287|Drug|F-18-AV45|The study will enroll 200 patients with prodromal AD and mild AD dementia and 100 normal controls, men and women aged 55-80 years across core clinical criteria of prodromal AD and mild AD dementia based on IWG-2 criteria.
15833778|NCT04174274|Other|ventilator-associated pneumonia-developed group followed by mechanical ventilation|compliance with ventilator-associated pneumonia prevention methods and investigating the incidence of ventilator-associated pneumonia in intensive care units
15833779|NCT04174274|Other|not ventilator-associated pneumonia-developed group followed by mechanical ventilation|compliance with ventilator-associated pneumonia prevention methods and investigating the incidence of ventilator-associated pneumonia in intensive care units
15833780|NCT04174261|Drug|Ticagrelor|Preprocedural ticagrelor loading and standard dose thereafter
15833781|NCT04174261|Procedure|Remote Ischemic Preconditioning|Preprocedural remote ischemic preconditioning on the non-dominant arm
15833782|NCT04174261|Drug|Clopidogrel|Preprocedural clopidogrel loading and standard dose thereafter
15833783|NCT04174248|Other|BCSMS App|Breast Cancer Using a Self-Management Support mHealth Application
15833784|NCT04174235|Device|Ultrasound scan|A full history taking was obtained according European surveillance of congenital anomalies EURO-CAT core data. All women underwent abdominal and transvaginal US (Toshiba Xario 200 unit)
15833785|NCT04174222|Other|Moderate NMB|Neuromuscular block was maintained at train of four count 1-2.
15833786|NCT04174222|Other|Deep NMB|Neuromuscular block was maintained at train of four count 0 and post-tetanic count1-2.
15833787|NCT04174209|Behavioral|Cylinder|Patients who receive the Jackson Cross Cylinder Method
15833788|NCT04174209|Behavioral|Dial|Patients who receive the Astigmatic Dial Technique Method.
15833789|NCT04174209|Behavioral|Slit|Patients who receive the Stenopeic slit Method.
15833790|NCT04174196|Drug|CC-486|Participants will be treated with CC-486 and lenalidomide for 6 cycles
15833791|NCT04174196|Drug|Lenalidomide|Participants will be treated with CC-486 and lenalidomide for 6 cycles
15833792|NCT04174196|Radiation|Radiation Therapy|Radiation therapy will be initiated to the plasmacytoma after cycle 2
15833793|NCT04174183|Device|Closed-incision Negative-pressure Therapy - Dry dressing|A Closed-incision Negative-pressure Therapy is applied on one groin incision - A dry dressing is applied on one groin incision .
15833794|NCT04174170|Drug|Brexpiprazole|Up to 3 mg pill
15833795|NCT04174170|Drug|Sertraline|Up to 150 mg pill
15833796|NCT04174170|Other|Placebo|Pill
15833797|NCT04174157|Other|Prospective observational registry|This prospective observational registry will assess long-term outcomes of patients with a diagnosis of SMA.
15833798|NCT04174157|Drug|Zolgensma|Zolgensma will be given to patients as per normal clinical practice and clinical care will not be mandated by the protocol. As such, the decision to prescribe Zolgensma is separate from the decision to include the patient in this study
15833799|NCT04174144|Procedure|Single-level TLIF|Transforaminal interbody fusion approach, using polyaxial pedicle screws (Xia®, Stryker Spine, Allendale, NJ, USA), combined with a crescent-shaped interbody cage (T-Plus®, Pioneer Surgical Technology, Marquette, MI, USA), bilateral facet joint removal and laminectomy.
15833800|NCT04174131|Device|Restylane + Lidocaine|Restylane + Lidocaine is a HA gel generated by Streptococcus species of bacteria, chemically crosslinked with BDDE, stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL with 0.3% lidocaine. It is indicated for mid-to-deep dermal implantation for the correction of moderate to severe facial wrinkles and folds, such as NLFs.
15833801|NCT04174131|Device|Restylane® Lyft|Restylane® Lyft is a sterile gel of HA with lidocaine generated by Streptococcus species of bacteria, chemically cross-linked with BDDE (the cross linker), stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL. Lyft is intended to be used for facial tissue augmentation (Galderma Laboratories, 2014).
15833802|NCT04174118|Drug|belcesiran|belcesiran will be administered subcutaneously (SC) at dose levels planned.
15833803|NCT04174118|Drug|Placebo|Sterile normal saline (0.9% NaCL) matching volume of belcesiran doses will be administered subcutaneously (SC).
15833804|NCT04174105|Genetic|AT845|AT845 is an AAV8 vector delivering a functional copy of the human GAA gene, under the control of a muscle-specific promoter
15833805|NCT04174092|Other|completing self-questionnaires|completing self-questionnaires on quality of life, anxiety, insomnia, activity of rheumatic disease and catastrophism
15833810|NCT04174053|Device|Enteric capsule|Enteric capsule to measure body temperature will be ingested every 24 hours during aplasia. the temperature measured with this technique will be compared with auricular temperature measurement (in current practice nurse measure temperature every 4 hours during aplasia).
15833811|NCT04174040|Behavioral|Gross's Process of Emotion Regulation Model Interventions|"Interventions were based on Gross's Process Model which include the basis concepts of cognitive-behavioral therapy and carried on with five semi-structured sessions. Cognitive-behavioral theories accept the existence of a thought process (attention-perception-interpretation) that appears in the mind about the event just before the anger emerges. Therefore, anger studies with cognitive-behavioral approach generally proceed with the steps of gaining awareness about this concealed thought, identifying behavioral response and avoidance attitudes and thus regulating emotion. It consists of five 90-minute group sessions structured in this context. While being an accredited cognitive behavioral therapist, investigator have qualified to manage these approach.
~The effectiveness of these semi-structured sessions were evaluated by using:
~Pretest application of STAXI
~Taking feedback after each intervention session
~Posttest application of STAXI
~Follow-up test application of STAXI"
15833812|NCT04174040|Behavioral|Musical Rhythm Interventions|"This musical group rhythm intervention was continued with 90 minute long five sessions. The students participated in the practice together with a music expert and lead researcher. The lead researcher took on the role of observer in these sessions. Each session was continued with warming, improvisation and targeted semi-structured rhythm practices aiming anger regulation. The effectiveness of these semi-structured sessions were evaluated by using:
~Pretest application of STAXI
~Taking feedback after each intervention session
~Posttest application of STAXI
~Follow-up test application of STAXI"
15833813|NCT04174040|Behavioral|Musical Rhythm Integrated Gross's Emotion Regulation Process Interventions|"The students participated in the practice together with a music expert and lead researcher. The lead researcher ensured the integration of rhythm applications into the Process Model through cognitive-behavioral semi-structured interventions. Five semi-structured 90-minute group sessions were performed. The effectiveness of the experiment was evaluated by using:
~Pretest application of STAXI
~Taking feedback after each intervention session
~Posttest application of STAXI
~Follow-up test application of STAXI"
15833814|NCT04174014|Procedure|Recruitment manoeuvre|PEEP increment and decrement
15833815|NCT04173988|Genetic|alloCART-19|"AlloCART-19 is an allogeneic CAR-T cell product targeting CD19.
~For children with body weight ≤ 50 kg, dose range for dose escalation will be 0.5 - 5 × 10^6 CAR+ cells/kg
~For children with body weight > 50 kg, dose range for dose escalation will be 0.25 - 2.5 × 10^8 CAR+ cells."
15833816|NCT04173988|Drug|Cyclophosphamide|Chemotherapy for lymphodepletion
15833817|NCT04173988|Drug|Fludarabine|Chemotherapy for lymphodepletion
15833818|NCT04173975|Device|With knee exoskeleton|BELK is a wearable system that assists when and where the patient needs it intelligently through proper control of the system and optimized gait assistance techniques. Assisted-as-needed control allows to create a force field along a desired trajectory, proportionally applying torque only when patient deviates from the pre-programmed correct pattern. This force field control, by assisting only the segments that the patient need, produces a natural gait pattern, improving the rehabilitation process.
15833819|NCT04173962|Drug|Ketamine|administered 1 week prior to a laboratory-induced stress
15833820|NCT04173962|Drug|Midazolam|administered 1 week prior to a laboratory-induced stress
15833821|NCT04173949|Drug|Ramipril 2.5 MG|3 month of treatment with daily Ramipril 2.5 MG
15833822|NCT04173936|Behavioral|tai chi|12-week community-based tai chi program
15833823|NCT04173923|Drug|Herbal medicine|Herbal medicine will be administered in water-based decoction (120ml) and dried powder (2g) form (Ostericum koreanum,Eucommia ulmoides, canthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, aposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycinemax, Atractylodes japonica) at the physician's discretion.
15833824|NCT04173923|Procedure|Chuna manual medicine|Chuna is a Korean manual therapy directed at the spine and joints that incorporates various spinal manual medicine techniques for joint mobilization involving high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement. Chuna manual medicine will be administered to the pelvic, lumbar, thoracic, and cervical vertebrae at the physician's discretion.
15833825|NCT04173923|Procedure|Pharmacopuncture|Pharmacopuncture consisting of select herbal ingredients will be administered at Hyeopcheok (Huatuo Jiaji, EX B2), Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea) at the physician's discretion.
15833826|NCT04173923|Procedure|Acupuncture|Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
15833827|NCT04173923|Procedure|Electroacupuncture|Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
15833828|NCT04173923|Procedure|Cupping|Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.
15833829|NCT04173923|Procedure|Other intervention(s)|Patients will be allowed any other additional intervention(s) as deemed necessary regardless of type or dose, and patterns of use will be investigated and recorded as a pragmatic clinical study.
15833830|NCT04173910|Procedure|Ultrasound LPEC/Sellick|We will perform an ultrasound of the carotid artery and then apply a Sellick manoeuvre and a left paratracheal compression of the cervical esophagus respectively.
15833831|NCT04173897|Other|LIBERATE website|The LIBERATE intervention is a self-management, symptom monitoring and signposting website tailored to the supportive needs of women living with secondary breast cancer. Components include; holistic health information specific to secondary breast cancer, symptom monitoring and self-management advice, case studies, signposting to services & support and support for family & loved ones.
15833832|NCT04173884|Other|Coaching|Surgical coaching is based on a peer coaching model that has been proven to be highly effective in other disciplines and for surgeons in training. Surgical coaching can improve technical performance in one of two ways: 1) identifying new or alternative approaches to the procedure; or 2) improving surgeon technical skill, which can lead to improvements in patient outcomes. In this proposal, our primary objective is to evaluate the effectiveness of video-based collaborative learning for surgeons.
15833872|NCT04173624|Diagnostic Test|Magnetic Resonance Cholangiopancreatography|Magnetic Resonance Cholangiopancreatography (MRCP) is non-invasive method for evaluating pancreatic and biliary pathology
15833833|NCT04173884|Other|Constructive Feedback|Constructive feedback is critical for performance improvement. It is currently unknown, however, whether asynchronous constructive feedback alone, without interactive discussions with a coach, would be as acceptable and valued as formal in-person coaching. Furthermore, the effectiveness of either approach to collaborative learning in improving surgical performance and outcomes is not known.
15833834|NCT04173871|Device|Protac Myfit®|A systematic proprioceptive-tactile stimulation by the Protac MyFit® vest. The children are asked to wear the Protac Myfit® vest from the beginning of every school day and for at least two sessions for three weeks.
15833835|NCT04173858|Drug|Naloxegol|25 mg oral naloxegol once daily.
15833836|NCT04173845|Drug|Tianqi Pingchan Granule|Tianqi Pingchan Granule are given twice a day
15833837|NCT04173845|Drug|Tianqi Pingchan Granule Placebo|Tianqi Pingchan Granule Placebo
15833838|NCT04173832|Drug|Tianqi Pingchan Granule Combined With Amantadine|Tianqi Pingchan Granule and Amantadine are given to patients simultaneously
15833839|NCT04173832|Drug|Placebo Combined With Amantadine|Placebo and Amantadine are given to patients simultaneously
15833840|NCT04173819|Biological|3BNC117-LS-J|300mg
15833841|NCT04173819|Biological|10-1074-LS-J|300mg
15833842|NCT04173819|Biological|Combination 3BNC117-LS-J and 10-1074-LS-J|30mg/kg of each
15833843|NCT04173819|Biological|Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 1|Total ~300 mg (< 2.5 ml) combined of 3BNC117-LS-J and 101074-LS-J - Dosage ratios chosen will be those considered worthy of further investigation based on the safety and preliminary PK observed in groups 1-2
15833844|NCT04173819|Biological|Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 2|Total ~300 mg (< 2.5 ml) combined of 3BNC117-LS-J and 101074-LS-J - Dosage ratios chosen will be those considered worthy of further investigation based on the safety and preliminary PK observed in groups 1-2
15833845|NCT04173819|Biological|Combination 3BNC117-LS-J and 10-1074-LS-J Ratio 3|Total ~300 mg (< 2.5 ml) combined of 3BNC117-LS-J and 101074-LS-J - Dosage ratios chosen will be those considered worthy of further investigation based on the safety and preliminary PK observed in groups 1-2
15833846|NCT04173819|Biological|Placebo|0.9% Saline
15833847|NCT04173819|Biological|Placebo|Buffer Solution
15833848|NCT04173806|Other|Facebook intervention|"The intervention consists of the content of the course on telemedicine through a closed group of Facebook according to the established syllabus whose educational material is video classes, discussion forums and online questionnaires. The duration of the course will be 5 weeks, each week two classes will be uploaded to the Facebook platform in succession until the course is completed. So that the student can visualize the content progressively and continuously."
15833849|NCT04173806|Other|Control Training:|In this group the participants are exposed to the same course content and perform similar activities as the intervention group on Facebook during the same period but on the Moodle educational platform. The Moodle platform was chosen because it has been widely used in several institutions, with a large user community worldwide, with approximately 50,000 registrations in more than 200 countries and due to the many easy-to-use educational tools it offers. So it is one of the educational platforms that has demonstrated its efficiency in the medical educational field.
15833850|NCT04173793|Drug|AK102|Administered by subcutaneous injection
15833851|NCT04173793|Drug|Placebo|Administered by subcutaneous injection
15833852|NCT04173793|Drug|Statins and/or Ezetimibe|Lipid-lowering therapies
15833853|NCT04173780|Drug|Atropine 0.01%|1 drop per day in both eyes for 1 year
15833854|NCT04173780|Drug|Placebo|1 drop per day in both eyes for 1 year
15833855|NCT04173767|Device|high flow nasal cannula ventilation|High-flow nasal cannula (HFNC) ventilation therapy: supply heated & humidified air up to 60 L/min of flow; effects: positive end expiratory pressure effect, humidification.
15833856|NCT04173754|Procedure|Motion Style Acupuncture Treatment(MSAT)|Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle created in Jaseng Hospital. This treatment involves patients with musculoskeletal pain to move the part of their body actively during acupuncture treatment under physicians' observation
15833857|NCT04173741|Other|USG measurement|IVC was visualized in the subxiphoid long axis by using convex probe (5-1 MHz). Diameters of IVC was measured 2 cm caudally to the junction of hepatic vein in M-mode. IJV diameter was measured in the short axis by using linear probe (12-5 MHz) and M-mode. IJV visualized in the junction of cricothyroid membrane level and midclavicular line. Maximum and minimum diameter values were measured in the M mode. Distensibility (maximum diameter - minimum diameter / minimum diameter) and collapsibility (maximum diameter - minimum diameter / maximum diameter) indices were calculated after USG measurements were done.
15833858|NCT04173728|Dietary Supplement|Standard meal|Consumption a standard meal consisted of 75g glucose, 60g fat and 20 protein just for once.
15833859|NCT04173715|Behavioral|Older Adults Group.|Physical activity and energy expenditure quantification
15833860|NCT04173715|Behavioral|Low Physical Function Status Group|Physical activity and energy expenditure quantification
15833861|NCT04173715|Behavioral|Medium Physical Function Status Group|Physical activity and energy expenditure quantification
15833862|NCT04173715|Behavioral|High Physical Function Status Group|Physical activity and energy expenditure quantification
15833863|NCT04173702|Diagnostic Test|balance analysis|Computerized balance analysis system will use to evaluate postural sway and limits of stability at four different support surfaces.
15833864|NCT04173689|Device|Threshold IMT|7 days a week, 2 times a day 15 min each
15833865|NCT04173689|Other|breathing exercises combined with upper extremity and trunk|upper extremity and trunk exercises combined with breathing exercises for 7 days a week, 2 times a day for 15 minutes each
15833866|NCT04173676|Drug|Indocyanine Green for Injection|The sentinel lymph nodes were observed by submucosal injection of ICG
15833867|NCT04173663|Behavioral|ASSIST|The ASSIST program is a 12-week advocacy training to educate parents of youth with ASD about the adult service system. It is a group training, comprised of didactic instruction, family-sharing activities, case studies, and group discussions. The ASSIST program for the proposed study will be directed at each site by an experienced Program Facilitator from the community with knowledge about group processes, person-centered planning, and adult service systems, who will be coached by a member of the study team. The ASSIST program will be delivered in full partnership with the local disability community. In most sessions, the Program Facilitator will be aided by community content experts who present the specifics of each topic.
15833876|NCT04173598|Behavioral|Cognitive Adaptation Training for Caregivers (CAT Famille)|Family CAT manual, with a module each week to be read according to the patient's objectives and a 15-minute webcam feedback by the psychologist.
15833877|NCT04173598|Behavioral|Usual Care|Psycho-education manual, with a weekly reading module and a 15-minute webcam feedback by the psychology student.
15833878|NCT04173585|Drug|Bortezomib|Bortezomib is a small molecule dipeptide binding the catalytic site of the 26 S proteasome. It acts as a potent, reversible, and specific inhibitor of proteasomes and thus impairs the degradation of ubiquitinated proteins. It has demonstrated anti-neoplastic activity in myeloma and lymphoma. It is approved and widely used in multiple myeloma both for first line treatment and relapsed patients.
15833879|NCT04173585|Drug|Gemtuzumab Ozogamicin|Gemtuzumab Ozogamicin is a monoclonal antibody directed against the myeloid surface antigen CD33. The antibody is linked to calicheamicin which serves as cytotoxic agent. For years, gemtuzumab ozogamicin has been tested in clinical AML trials. Though withdrawn from the US market in 2010, FDA approval was granted in September 2018, EU approval in April 2018 based on encouraging results from recent clinical trials using enhanced dosing schedules.
15833880|NCT04173572|Behavioral|PACE-Life|PACE-Life Groups will occur twice per week for 15 minutes in the first two weeks, progressing to 30-minute walking sessions over the course of the intervention without changes in frequency. The intensity of virtual walks will increase throughout this intervention in a stepwise fashion to create an exercise dose response to maximize impact on CRF.
15833881|NCT04173572|Behavioral|Exercise Intervention|Data from Fitbit devices will be synced and accessed through Fitbit.com. Participants will be provided account information to view data but will be asked not to change any of the settings as the investigators will be using data for tracking steps/day and minutes spent walking.
15833882|NCT04173559|Behavioral|Activity Intervention|After 1 week of baseline activity is obtained, participants will be contacted with personalized activity goals that are 10% higher than their previous weeks' activity levels. They will also receive feedback regarding sleep if they are not averaging at least 6 hours per night or if they are waking more than twice per night. Participants will also receive weekly text reminders and encouraging feedback, and will receive additional counseling in person at regularly scheduled prenatal visits until delivery.
15833885|NCT04173520|Drug|DDA|Follow up after SVR
15833886|NCT04173507|Drug|Avelumab|Given IV
15833887|NCT04173507|Drug|Talazoparib|Given PO
15833888|NCT04173507|Drug|Talazoparib Tosylate|Given PO
15833889|NCT04173494|Drug|Momelotinib|Momelotinib tablets will be self-administered orally once daily
15833890|NCT04173494|Drug|Danazol|Danazol capsules will be self-administered orally twice daily
15833891|NCT04173494|Drug|Placebo to match momelotinib|Momelotinib placebo tablets will be self-administered orally once daily
15833892|NCT04173494|Drug|Placebo to match danazol|Danazol placebo capsules will be self-administered orally twice daily
15833893|NCT04173481|Other|Rood's Group|"ROOD'S sensory motor training
~Brushing & strokings 3-5 strokings after 30sec, joint compressions and slow stretch 10 rep of 3 sets on alternative days for consecutive 6 weeks CIMT training
~Writing, combing hairs and using spoon activity 1 hour training concentrated on affected limb along with restraint of non affected limb by cotton sling under supervision of therapist and 5 hours training in home plan 3 times a week on alternative days for consecutive 6 weeks along with conventional physical therapy."
15833894|NCT04173481|Other|Conventional Physical Therapy Group|Conventional training Proprioceptive neuromuscular facilitations (PNF) Combination of Isotonics technique 10 rep 3 sets 10 sec hold on alternative days for consecutive 6 weeks Stretching's 10 rep 3 sets on alternative days for consecutive 6 weeks Joint approximation 10 rep of 3 sets on alternative days for 6 weeks
15833895|NCT04173468|Other|Moblization with Movement|patients with group 1 will receive two techniques pertaining to MWM intervention (straight leg raised with traction and tibial Gliding) Repeat it 10 times,3 sets and 1 mint interval. .For Tibial Gliding we will asks the patient to perform 10 repetitive active knee extensions. Practice will be performed by doing 10 reps for 3 sets with 1 min interval. After this home exercises will b guided stretching of hamstrings 8 to 10 reps 20 sec hold, strengthening of Quadriceps and VMO with 10 reps and 3 sets
15833896|NCT04173468|Other|Mulligan knee taping|patient with group 2 will receive Mulligan taping technique. Tape will be applied for two days then we will change it. After this home based exercise will be guided which is stretching of hamstrings 8 to 10 reps 20 sec hold , strengthening of Quadriceps and VMO with 10 reps and 3 sets.
15833897|NCT04173455|Drug|HZ-A-018|"In the dose-escalation part, subjects will be assigned to five cohorts with increaing dose level to determine DLT and MTD during the first 28-day cycle.
~In the expansion part, subjects will be assigned to two fixed dose corhort."
15833898|NCT04173442|Drug|dupilumab|Dupilumab cohort
15833899|NCT04173429|Drug|Nadroparin calcium, warfarin|Nadroparin calcium subcutaneously every 12hs for 1 months followed by warfarin orally for 5 months. INR(international normalized ratio ) was detected every 3-4 days and adjusted carefully by 0.75mg dosage until achieve the target level of 2-3.
15833900|NCT04173416|Behavioral|Youth Opioid Recovery Support (YORS)|The Youth Opioid Recovery Support (YORS) model is an innovative wrap-around approach that attempts to address barriers to treatment engagement in this vulnerable young adult population, especially difficulties with medication adherence. Its components include: (1) Home delivery of extended release naltrexone (XR-NTX) for OUD; (2) Engagement of families in collaborative treatment planning and monitoring focusing on medication adherence; (3) Assertive outreach from the treatment team including actively tracking and communicating with youth and families by text messaging and social media to promote engagement and adherence; and (4) Contingency management to provide incentives for medication adherence.
15833901|NCT04173403|Drug|450mg AK102|AK102 Q4W
15833902|NCT04173403|Drug|300mg AK102|AK102 Q4W
15833903|NCT04173403|Drug|150mg AK102|AK102 Q2W
15833904|NCT04173403|Drug|Statins and/or Ezetimibe|Lipid-lowering therapies
15833905|NCT04173390|Drug|Pregabalin 150mg|Preemptive use of pregabalin 150 mg starting three days before surgery up to the third postoperative day
15833906|NCT04173390|Drug|Placebo oral tablet|Preemptive use of Placebo oral tablet starting three days before surgery up to the third postoperative day
15833907|NCT04173364|Drug|Ropivacaine 0.5% Injectable Solution|Injectable solution of ropivacaine 0.5%
15833909|NCT04173351|Behavioral|Education and Counseling|Following the pretests between the 28th and the 34th gestational weeks, nulliparous women in the intervention group received a presentation on childbirth preparation at a room of the obstetrics clinic. The education was completed in two sections in a single day. Each session took about 45 minutes there was a 15-minute break between the sessions. Following the education, the questions of the participants were responded and educational brochures on childbirth preparation were given to the participants. One of the researchers of this study telephoned the participant women in the intervention group one week after the childbirth education and provided counseling service about the demands and the points that the nulliparous women wondered.
15833910|NCT04173338|Drug|Cabozantinib|start at 20mg then increase by 20mg every cycle or until there's a dose-limiting toxicity.
15833911|NCT04173338|Drug|Pemetrexed|Start with 400mg/m2, then increase and maintain 500mg/m2 unless dose-limiting toxicity.
15833912|NCT04173325|Drug|Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]|PD-1 inhibitor approved by the US FDA for treatment of patients with lung cancer.
15833913|NCT04173325|Drug|Irinotecan Injection [Camptosar]|Chemotherapy drug currently FDA approved for treatment of multiple tumors, including small cell lung cancer.
15833914|NCT04173312|Combination Product|Bupivacaine infusion|Local systemic Infusion of anesthetic
15833915|NCT04173312|Combination Product|Saline|Local systemic infusion of saline
15833916|NCT04173299|Procedure|early tips|patients with early tips
15833917|NCT04173286|Procedure|antibiotherapy|< 7 days
15833918|NCT04173273|Drug|Etrasimod|Dose A taken by mouth, once daily.
15833919|NCT04173273|Drug|Etrasimod|Dose B taken by mouth, once daily.
15833920|NCT04173273|Drug|Placebo|Etrasimod matching placebo tablet taken by mouth, once daily.
15833921|NCT04173260|Drug|Deutetrabenazine 6 MG|Increasing doses of Deutetrabenazine
15833922|NCT04173247|Device|KeraStat Cream|KeraStat Cream is a non-sterile, non-implantable, emollient-based wound dressing intended to act as a protective covering in the management of a variety of skin conditions.
15833923|NCT04173247|Other|Routine Skin Care - Commercially Available Agents|Commercially available skin moisturizers from an approved list that do not interfere with radiation.
15833924|NCT04173234|Other|Aerobic Training|Aerobic training will be performed 3 days a week for 12 weeks at 60% of their maximum hearth rate with 50 minutes total duration consisting of 10 min warm up and 10 min cool down period to children in treatment group.
15833925|NCT04173234|Other|Home exercise program|Children will be given a home program including stretching, breathing, normal joint movement, body weight and mildly resistant exercises, and children will be asked to do these for 3 to 5 days a week.
15833926|NCT04173221|Other|Sublingual SDF-Measurement with communication and interpreting checklist to the treating physician|Sublingual SDF-Measurement at admission and after 24h, with communication and interpreting checklist to the treating physician
15833927|NCT04173221|Other|Sublingual SDF-Measurement without communication and interpreting checklist to the treating physician|Sublingual SDF-Measurement at admission and after 24h, without communication and interpreting checklist to the treating physician
15833928|NCT04173208|Other|Fecal microbial transplant|Fecal microbial transplant
15833929|NCT04173208|Other|Placebo|Placebo
15833930|NCT04173195|Other|Comfort Talk|A short and brief conversation based on the principles of clinical hypnosis.
15833931|NCT04173182|Diagnostic Test|Probe-based confocal laser endomicroscopy evaluation|Colonoscopy with confocal laser endomicroscopy evaluation of the peridiverticular and colonic mucosa on patients with diverticular disease
15833934|NCT04173156|Device|Labrida Bioclean|The brush bristles of the test device (Labrida BioClean®, LABRIDA, Oslo, Norway) are made of the biopolymer chitosan
15833935|NCT04173156|Device|Gracey Periodontal curettes|Regular commercially available area specific and medical grade steel Gracey periodontal curettes
15833936|NCT04173143|Device|Craniocervical flexion training with pressure biofeedback|Total 15 patients participated in this training group. Session was performed thrice in a week. Each session was givenfor approximately 20minutesPatients were asked to lie in supine hook lying position. After that Pressure biofeedback unit's air bag was clipped together and folded in three and positioned behind the neck just below the occiput. Patients were advised to perform Craniocervical flexion and practiced head nodding action to progressively target (reach the incremental targets) and hold the 5 pressure levels for 10 second between 22 mm Hg and 30 mmHg. A 2 minute second rest period was provided between each level. Minimum performance requirement was 26 mm Hg while ideal performance targets are 28 and 30 mm Hg... Patient will be re-assessed for all baseline variables after 4 weeks of training
15833937|NCT04173143|Other|Craniocervical flexion training without pressure biofeedback|Total 15 patients participated in this control group.Session was given 3 times in a week. Each session continue forapproximately 20 minutes. The patient lies in supine crook lying position. The patientwas maximally retracted the chin and asked to maintained it while the patient lifts the head and neck until the head is relatively 2 to 5 cm (1 inch) abovethe couch. The examiner places a hand under the head of patient on the table. Patients were instructed to perform10 repetitions for a hold of 20 seconds initially, increasing it by 10 seconds progressively.The entire session had a maximum of 4 sets. Patient will be re-assessed for all baseline variables after 4 weeks of training
15833938|NCT04173130|Device|Anuscope with needles|Injection of botulinum toxin into the anal sphincter with the investigational device (anuscope with needles).
15833939|NCT04173117|Dietary Supplement|Low energy meal replacement plan (12 weeks)|Low energy meal replacement plan (12 weeks)
15833942|NCT04173091|Diagnostic Test|No Intervention|No Intervention planed
15833943|NCT04173078|Behavioral|Computerized Distress Intolerance Intervention|
15833944|NCT04173078|Behavioral|Computerized Healthy Behaviors Intervention|
15833945|NCT04173065|Drug|VK2809|Capsule
15833946|NCT04173065|Drug|Placebos|Capsule
15833947|NCT04173052|Device|Testis' shocker|The device gives electrical shock ranged (1-5) milliAmpere designed to fit the testis shape for the males.
15834199|NCT04171037|Procedure|Oxygen Therapy|Receive oxygen via non-rebreather
15833948|NCT04173039|Diagnostic Test|Serum anti-CarP antibodies detection|Serum anti-CarP antibodies detection using an enzyme-linked immunosorbent assay (ELISA) from Inova Diagnostics.
15833949|NCT04173026|Other|Provider-level intervention|Provider minder is a provider-based scheduling and reminder system for stroke screening in SCD
15833950|NCT04173026|Other|Patient-level intervention|50% of centers are randomized to a single stroke screen coordinator as the point of contact for sickle stroke screen
15833951|NCT04173013|Biological|Uromune|2 sprays of solution once daily for a total of 3 months.
15833952|NCT04173000|Other|Mehealth for ADHD software with medication continuity tools|Medication continuity tools integrated within the mehealth for ADHD software will assess factors influencing medication continuity for each adolescent and recommends tools to address relevant factors. Tools include 1) a system to track outcomes and resolve uncertainty about the need for and/or benefit from medicine, 2) a module to address stigma, 3) a module to help manage side effects, and 4) reminders to take medicine and/or request refills.
15833953|NCT04173000|Other|Mehealth for ADHD software without medication continuity tools|"The mehealth for ADHD software has multiple functionalities including 1) online training regarding the American Academy of Pediatrics (AAP) ADHD guidelines; 2) an ADHD workflow wizard that guides pediatricians through the creation of an efficient office workflow to deliver quality ADHD care; 3) online collection of parent- and teacher-report ADHD rating scales for the assessment of ADHD as well as monitoring response to medication treatment; 4) integrated algorithms that automatically score rating scales in real time and provide pediatricians with assessment and treatment reports as well as immediate warnings; 5) a communication feature that allows parents, teachers, and pediatricians to communicate with each other; 6) an online pediatrician report card; and 7) a Plan-Do-Study-Act wizard that allows pediatricians to select a practice behavior to improve based on their report card and guides them through the creation of small tests of change to improve their office systems."
15833954|NCT04172987|Drug|Tirzepatide|Administered SC
15833955|NCT04172987|Drug|EE/NGM|Combination oral contraceptive administered orally
15833956|NCT04172974|Other|eHealth intervention|Modules developed for depression and anxiety based on cognitive behavioral therapy (CBT), acceptance and commitment therapy (ACT) and compassion-focused coping
15833957|NCT04172974|Other|Usual Care|Treatment according to national clinical guideline (referral to GP)
15833958|NCT04172961|Drug|nanomicellular cyclosporine 0.09%|topical ophthalmic drop prior to elective surgery for eligible patients
15833959|NCT04172961|Drug|Lifitegrast|topical ophthalmic drop prior to elective surgery for eligible patients
15833960|NCT04172948|Device|Oculus go headset/virtual reality headset|10 minute virtual reality tutorial on diaphragmatic breathing, a game in practicing diaphragmatic breathing, and two scenarios in which the patient can also practice diaphragmatic breathing.
15833961|NCT04172948|Behavioral|Diaphragmatic breathing|10 minute tutorial on diaphragmatic breathing by a medical professional.
15833962|NCT04172935|Device|Presbyopic Glasses/ Intervention Group|Immediate provision of a free pair of spherical presbyopic glasses to correct the worker's vision for optimal picking distance, astigmatism is corrected.
15833963|NCT04172922|Drug|Topical Sirolimus|Open label, topical sirolimus (1%) cream will be applied to cutaneous component of complicated vascular anomalies twice daily for 4 weeks and once daily thereafter- for the duration of study.
15833964|NCT04172909|Other|LEGO Bricks MRI|LEGO Bricks model MRI (A model of the MRI machine and adjacent control room made out of LEGO bricks) will be used by the child life specialist to prepare the child for MRI
15833965|NCT04172909|Other|Mock MRI tube|Mock MRI tube will be used by the child life specialist to prepare the child for MRI
15833966|NCT04172896|Procedure|Intraperitoneal Uterosacral Ligament Suspension|Vaginal intraperitoneal uterosacral ligament suspension performed by transfixing the ligament, intraperitoneally, in the intermediate portion (at the level of or above ischial spine plane) with three delayed absorbable 0 sutures, performed bilaterally (three sutures per side; six sutures total).
15833967|NCT04172896|Procedure|Extraperitoneal Uterosacral Ligament Suspension|Vaginal extraperitoneal uterosacral ligament suspension performed by transfixing the ligament, extraperitoneally, in the intermediate portion (at the level of or above ischial spine plane) using a suture capturing device with two delayed absorbable 0 sutures, performed bilaterally (two sutures per side; four sutures total).
15833968|NCT04172883|Other|Treatment arm|All pts are implanted with rATP enabled devices prior to the study start , the only intervention in both arms is switching on rATP and in the treatment arm programming changes done to optimize the rATP sequence delivery of therapy and prevent the patient from going into permanent or persistent AF
15833969|NCT04172870|Diagnostic Test|Molecular analysis|RT- PCR
15833970|NCT04172857|Procedure|anterior vitrectomy combined with hyaloidotomy, zonulectomy and iridectomy|First, a 23-G incision was made at the peripheral inferior temporal sector of the cornea and connected with an anterior chamber infusion cannula. Another corneal incision was made at the superior temporal sector or superior nasal sector, and Viscoat® (Bausch & Lomb, Shandong, China) was infused though the incision to fill the anterior chamber. Iridotomy was performed through the incision using Wescott scissors and toothed forceps. Hyaloidectomy and zonulectomy were performed through a peripheral iris defect using an anterior chamber approach to set up a pathway between the anterior chamber and the vitreous cavity. We repeatedly carried out vitrectomy around the pathway to reduce the risk of postoperative re-obstruction of the tunnel created.
15833971|NCT04172844|Drug|Azacitidine|75mg/m^2 Days 1-7 given IV
15833972|NCT04172844|Drug|Venetoclax|100 mg on cycle 1 day 1, 200 mg daily on cycle 1 day 2, 400 mg on cycle 1 day 3 and thereafter from cycle 1. Venetoclax is given for a minimum of 21 days and a maximum of 28 days. Administered orally.
15833973|NCT04172844|Drug|Pevonedistat|The doses for the 3 + 3 design (dose escalation phase) are listed in the arm description. The dose-expansion phase will use the maximum-tolerated dose.
15833974|NCT04172831|Drug|TNX-102 SL|Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
15833975|NCT04172831|Drug|Placebo SL Tablet|Patients will take 1 tablet of randomly assigned study drug sublingually starting on Day 1 for 2 weeks. At the Week 2 visit, all patients will have the dose increased to 2 tablets for 12 weeks.
15834004|NCT04172571|Drug|Anlotinib Hydrochloride|multi-targeted receptor TKI; oral administration; every 3 weeks as one cycle administered as 2 weeks on/1 week off
15833976|NCT04172818|Behavioral|quality of life questionnaire|Since 10 years ago, diaries are used in intensive care unit to limit these symptoms after a coma.In analogy, the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences. The psychological impact of a diary on patients hospitalized for allogenic hematopoetic stem cell transplantation and on their relatives will be evaluated.
15833977|NCT04172805|Drug|anlotinib and toripalimab|Anlotinib 12mg orally per day, two weeks on , one week off; 240 mg of toripalimab (fixed dose) every three weeks. Repeat every three weeks. Patients with disease control (CR + PR + SD) and tolerable adverse reactions continued to take medication until the researchers concluded that patients were not suitable to continue medication or the efficacy evaluation was disease progression (PD). No other antineoplastic treatment can be given during the treatment.
15833978|NCT04172792|Dietary Supplement|high-caloric fatty diet|see arm/group description
15833979|NCT04172792|Dietary Supplement|ultra-high-caloric fatty diet|see arm/group description
15833980|NCT04172792|Dietary Supplement|ultra-high-caloric carbohydrate-rich diet|see arm/group description
15833981|NCT04172779|Drug|Erlotinib Hydrochloride|Oral administration of erlotinib 25mg tablet
15833982|NCT04172766|Behavioral|Advanced|"Advanced group users will receive prompts when an acutely high headphone audio level exposure (LEQ equivalent to >97 dBA for >30 minutes) occurs. Those in the WatchOS arm will be prompted when their weekly environmental sound level (7-day LEQ equivalent to >80 dBA for >40 hrs) is high. Either prompt will occur via notification, and will request that the participant review exposure data in the Research app and answer questions related to their exposure. The survey will ask for confirmation that they reviewed the exposure data and perceive it as accuracy, whether or not they used any hearing protection (e.g., ear plugs worn at a rock concert), and any intended listening behavior change resulting from their data review. To minimize notification burden for participants, exposure notification events will occur no more than twice per month. At this same frequency, they will be asked to take an abbreviated audiogram to test for temporary threshold shifts in their hearing level."
15833983|NCT04172753|Radiation|Radiotherapy on the MR-Linac|Radiotherapy is performed on the 1.5 T MR Linac
15833984|NCT04172753|Diagnostic Test|Imaging on the MR Linac|Only imaging performed on the MR Linac
15833985|NCT04172740|Device|Radiesse (calcium hydroxylpatite)|"RADIESSE® injectable implant is a sterile, non-pyrogenic, semi-solid, cohesive implant, whose principle component is synthetic calcium hydroxylapatite (CaHA) suspended in a gel carrier of sterile water for injection, glycerin and sodium carboxymethylcellulose. RADIESSE injectable implant has a CaHA particle size range of 25-45 microns. RADIESSE is available in 1.5cc and 0.8cc pre-filled syringes.
~RADIESSE injectable implant is indicated for subdermal implantation for the correction of moderate to severe facial wrinkles and folds, such as nasolabial folds and it is also intended for restoration and/or correction of the signs of facial fat loss (lipoatrophy)."
15833986|NCT04172727|Drug|Bupivacaine Hcl 0.25% Inj|ultrasound-guided bilateral TFP block with 20 mL of 0.25% bupivacaine
15833987|NCT04172727|Drug|saline 0.9%|ultrasound-guided bilateral TFP block with 20 mL of saline 0.9%
15833988|NCT04172714|Device|SIR-Spheres microspheres|SIR-Spheres® Y-90 resin microspheres consist of biocompatible polymer resin microspheres of a median diameter of 32.5 microns (range between 20 and 60 microns) loaded with yttrium-90 (beta radiation penetrating an average of 2.5 mm in tissue to destroy tumor cells). The resin microspheres are small enough to become lodged in the arterioles within the growing rim of the tumor but are too large to pass through the capillaries and into the venous system. Since yttrium-90 has a half-life of 64.1 hours, most of the radiation (94%) is delivered to the tumor over 11 days.
15833989|NCT04172701|Drug|Long-acting Muscarinic Antagonists (LAMA)|drug
15833990|NCT04172701|Drug|Inhaled corticosteroid (ICS)/Long-acting Beta Agonists (LABA)|drug
15833991|NCT04172688|Dietary Supplement|Prebiotic oligofructose-enriched inulin|Synergy1
15833992|NCT04172688|Dietary Supplement|Placebo maltodextrin|Equicaloric dose of maltodextrin
15833993|NCT04172675|Drug|Erdafitinib|Participants will receive erdafitinib orally beginning on Cycle 1 Day 1 until 2 years of treatment have been completed, disease recurrence, intolerable toxicity, withdrawal of consent, a decision by the investigator to discontinue treatment, or study termination, whichever occurs first. Each cycle is of 28 days.
15833994|NCT04172675|Drug|Investigator Choice (Gemcitabine)|Investigator's Choice treatment will be given once weekly for at least 4 doses of induction followed by monthly maintenance for at least 6 months.
15833995|NCT04172675|Drug|Investigator Choice (Mitomycin C)|Investigator's Choice treatment will be given once weekly for at least 4 doses of induction followed by monthly maintenance for at least 6 months.
15833996|NCT04172662|Behavioral|Facilitated Music Listening|The patient gets a preparatory session with the music therapist one day before the invasive procedure, where individual assessment is made based on a biopsychosocial approach. Sequences of facilitated Music listening is provided during the pre-, peri and postoperative phase, and a closing dialog performed postoperatively. Patient-preferred music is chosen from a limited set of playlists provided on the app The Music Star.
15833997|NCT04172649|Other|Acupuncture|On the day before surgery, patients randomized to the intervention groups will receive routine postoperative analgesic care with application of 6 bilateral press tack needles (diameter of 0.15mm and length of 0.6mm for P-6 and Shenmen, diameter of 0.20mm and length of 1.2mm for SP-6, Seirin New Pyonex, Seirin Corp., Shizuoka City, Japan).
15833998|NCT04172649|Other|Acupressure|On the day before surgery, patients randomized to the intervention groups will receive routine postoperative analgesic care with application of 6 bilateral press tack placebos (knob without needle, diameter of 0.15mm and length of 0.6mm for P-6 and Shenmen, diameter of 0.20mm and length of 1.2mm for SP-6, Seirin New Pyonex, Seirin Corp., Shizuoka City, Japan).
15833999|NCT04172623|Behavioral|Real-Time Smoking Intervention|Adult smokers will use wearable technology in order to receive real-time feedback as a smoking intervention in addition to standard treatment.
15834000|NCT04172623|Behavioral|Standard Treatment|Adult smokers will receive standard outpatient tobacco treatment.
15834001|NCT04172597|Drug|Poziotinib Hydrochloride|The poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration.
15834002|NCT04172584|Behavioral|correct use of the contraceptions|know the emergency contraception and how to use
15834003|NCT04172571|Biological|AK105|Anti-PD-1 antibody; IV infusion, 200 mg Q3W
15834005|NCT04172558|Biological|OnabotulinumtoxinA|a single ICI of BTX-A 100 units one day after the penile Doppler/trimix test.
15834006|NCT04172558|Drug|Trimix|on demand ICI of Trimix
15834007|NCT04172545|Procedure|stapling|staples are fired through the gastric wall after waiting several seconds for compression without attention to blood pressure, fluids given or intra abdominal pressure, but these might have an impact on quality of stapling. therefore the conditions during stapling will be recorded during stapling.
15834008|NCT04172532|Radiation|Hypofractionated Radiation Therapy|Undergo hypofractionated radiation therapy
15834009|NCT04172532|Drug|Peposertib|Given PO
15834010|NCT04172532|Other|Placebo Administration|Given PO
15834011|NCT04172519|Other|Pre- and post prostatectomy supervised PMFT|intervention before and after surgery, supervised exercises
15834012|NCT04172519|Other|Unsupervised PMFT|intervention after surgery, unsupervised exercises
15834013|NCT04172519|Other|Supervised PMFT|intervention after surgery and supervised exercise
15834014|NCT04172506|Drug|AK105|Anti-PD-1 antibody
15834015|NCT04172493|Procedure|Hyperspectral Endoscopy (HySE)|Undergo hyperspectral endoscopy
15834016|NCT04172493|Device|White Light Endoscopy (WLE)|Undergo white light endoscopy
15834017|NCT04172480|Other|Blood sampling|Peripheral blood sampling on EDTA
15834018|NCT04172467|Other|non-interventional retrospective epidemiological observational study|non-interventional retrospective epidemiological observational study
15834019|NCT04172454|Biological|AK104|AK104, 6mg/kg, Q2W
15834020|NCT04172441|Drug|dasiglucagon|Glucagon analog
15834021|NCT04172441|Drug|Placebo|Placebo for dasiglucagon
15834022|NCT04172428|Diagnostic Test|Functional MRI (fMRI)|fMRI will be done on 3 separate MRI scanners to compare.
15834023|NCT04172415|Other|Retrospective cohort|Chart Review
15834024|NCT04172402|Drug|TS-1|Intervention is administered to patients in this Arm.
15834025|NCT04172402|Drug|Gemcitabine|Intervention is administered to patients in this Arm.
15834026|NCT04172402|Drug|Nivolumab|Intervention is administered to patients in this Arm.
15834027|NCT04172389|Procedure|vesico-vaginal fistula robot assisted laparoscopic repair|realization of O'conor technique or extra-vesical technique for vaginal vesico fistula repair in robot assisted coelioscopy
15834028|NCT04172376|Procedure|Minimally invasive puncture aspiration plus rt-PA|Stereotactic puncture aspiration to evacuate basal ganglion hematoma with use of thrombolytic agent
15834029|NCT04172376|Drug|Conservative medical treatment|Drugs for symptomatic treatment such as hemostasis and nerve nourishing.
15834030|NCT04172363|Drug|Octenisept and Serasept|Swab probes of wounds will be taken upon study inclusion and analysed for resistance on Octenisept and Serasept. If the patient indicates resistance on one of the antiseptics, he/she will receive the other antiseptic for wound dressings
15834031|NCT04172350|Other|iCareBreast|The iCareBreast BuddyCare mobile app is an interactive surgery preparation and recovery app for patients. It is a patient-centric care coordination and patient engagement mobile app that supports patients' perioperative journey. The app provides day-to-day information throughout the perioperative journey to patients from 2 weeks before surgery to 2 weeks after the surgery. Meanwhile the healthcare professional can monitor patients' use of the app. That is, the iCareBreast App provides patients with all the information about the surgery-related procedure and treatment via an efficient, user-friendly and interactive timeline. Patients will receive pop-up reminders daily for them to use the app. The objective of this app is to allow each patient to focus on caring for herself as a patient.
15834032|NCT04172350|Other|Routine care|Routine care provided by the hospital includes general information regarding pre-operation preparation and post-operative care (e.g. wound care, pain management and physiotherapy).
15834033|NCT04172337|Behavioral|Healthier Choice Symbol|The HCS is intended to improve diet quality by signaling to consumers which products are healthier options within a specific category (e.g., which are the healthier biscuits or the healthier beverages). Manufacturers must meet category-specific criteria before a product can display the HCS and an associated tagline. The labels were displayed at the bottom of the product images.
15834034|NCT04172337|Behavioral|Physical Activity Equivalent label|"For the study, we designed a simple PAE logo (Appendix Figure A1) and added a description encoded into the NUSMart user interface to ensure that participants would understand the contents of the label. Participants saw the following description whenever their cursor hovered over the PAE label: The Physical Activity Equivalent (PAE) refers to the number of minutes that a typical adult would need to jog to burn off the calories associated with one serving of the product. Previous studies have shown this labelling approach to be effective.
~The labels were displayed at the bottom of the product images."
15834035|NCT04172324|Device|HIBBOT|Hibbot is an assistive mechanical device, lightweight and portable. The mechanism of the Hibbot manages to control all degrees of freedom (3x rotation and 3x translation) at the level of the pelvis and lower trunk. The goal is to maximize a child's own muscle activity and postural control while giving as minimal support as needed.
15834036|NCT04172324|Other|Standard Care|Standard care involves the standard physiotherapy the child would get during clinical care.
15834037|NCT04172311|Other|Modified Atkins Diet|Modified Atkins diet is a type of ketogenic diet which is less restrictive
15834038|NCT04172311|Drug|Levetiracetam|Levetiracetam is a second generation anti-epileptic drug which is broad spectrum and commonly used as add-on in refractory epilepsy
15834039|NCT04172298|Other|sham electroacupuncture (EA) session|The stainless steels acupuncture needles inserted into the subcutaneous layer of Zusanli (cathode) and Shangjuxu acupints (anion) , and the needles connected to EA stimulator, but no electric discharge for 30 min.
15834040|NCT04172298|Other|Zusanli session|The acupuncture needles inserted into Zusanli (cathode) and Shangjuxu acupoints (anion), and twisting obtain qi, and the needles then connected to EA stimulator, the frequency was 2 Hz, the duration was 30 min, and the intensity was visual slightly muscle contraction.
15834041|NCT04172298|Other|Shaohai session|The methods were identical Zusanli group, but Shaohai acupoint (cathode), and 3 cm below Shaohai (anion).
15834042|NCT04172285|Behavioral|Physical activity|Home-based physical activity program
15834043|NCT04172285|Dietary Supplement|Physical activity and supplementation|Home-based physical activity program and amminoacid supplementation
15834044|NCT04172285|Other|Control|No intervention
15834183|NCT04171167|Drug|Fluticasone Propionate|three visits: 0, after washout, after FP usage
15834045|NCT04172272|Drug|Systemic multimodal analgesia administered intravenously|"Paracetamol 1 gram and ketoprofen 100 mg every 8 hours for 24 hours. Analgesia will start immediately after surgery. If the pain persists, the patient will be given rescue analgesia: tramadol 50 mg intravenously up to a maximum dose of 400 mg / 24 h and other analgesics if needed."
15834046|NCT04172272|Procedure|Transversus abdominis plane block (TAP block)|"The TAP block will be given postoperatively before waking. It will be given bilaterally in the before mentioned anatomic region (the so-called lateral TAP block) of 0.25% levobupivacin in 40 ml bilaterally. If the pain persists, the patient will be given rescue analgesia: tramadol 50 mg intravenously up to a maximum dose of 400 mg / 24 h and other analgesics if needed."
15834047|NCT04172272|Other|Combined transversus abdominis plane block (TAP block) with systemic multimodal analgesia administered intravenously|TAP block in addition to systemic, mutimodal analgesia. If such analgesia is not satisfactory, tramadol 50 mg intravenously, up to a maximum dose of 400 mg / 24h, and other analgesics will be given at the request of the patient.
15834048|NCT04172259|Drug|Doxorubicin liposome|PLD
15834049|NCT04172259|Drug|Cyclophosphamide|CTX
15834050|NCT04172259|Drug|Trastuzumab|H
15834051|NCT04172259|Drug|Docetaxel|DOC
15834052|NCT04172259|Drug|Epirubicin|EPI
15834053|NCT04172246|Drug|Zanubrutinib|Zanubrutinib at 160 mg orally twice daily
15834054|NCT04172233|Biological|AK101|AK101 is an anti-IL-12/23p40 monoclonal antibody.
15834055|NCT04172233|Biological|placebo|matching placebo
15834056|NCT04172220|Drug|Midazolam|1-2 mg of Midazolam as premedication.
15834057|NCT04172220|Procedure|PECS|"Loco-regional anesthesia: PEC I and serratus plane block with an echoguided technique.
~For the PEC I: infiltration of 10 ml of local anesthetic (Levobupivacaine 0.25% or Ropivacaine 0.5%) between the bands of the pectoralis major muscle and the small pectoralis muscle at the height of the third rib on the anterior axillary line.
~For the serratus plane block: identification of the fifth rib on the average axillary line and infusion of about 20 ml of local anesthetic (Levobupivacaine 0.25% or Ropivacaine 0.5%) between the bands of large dorsal muscle and of the anterior serratus muscle."
15834058|NCT04172220|Procedure|Opioid-free general anesthesia|"Induction with Propofol 1.5-2 mg/kg; laryngeal mask for airway management after eventual administration of Rocuronium 0.6 mg/kg. Anesthesia will be maintained with Propofol in Target-Controlled Infusion (TCI) of 6 mcg/ml, subsequently modified to maintain a Bispectral Index (BIS) value between 40 and 60.
~Fentanyl 50ug in bolus IV, in case of mean arterial pressure or heart rate increase >20%.
~In case of hypotension: 5mg ephedrine and infusion of 250 ml Lactated Ringer."
15834059|NCT04172220|Procedure|General anesthesia|"Induction with Propofol 1.5-2 mg/kg; Fentanyl 1μg/kg; laryngeal mask for airway management after eventual administration of Rocuronium 0.6 mg/kg. Anesthesia will be maintained with Propofol in TCI of 6 mcg/ml, subsequently modified to maintain a BIS value between 40 and 60.
~Fentanyl 50ug in bolus IV, in case of mean arterial pressure or heart rate increase >20%.
~In case of hypotension: 5mg ephedrine and infusion of 250 ml Lactated Ringer."
15834060|NCT04172220|Procedure|Postoperative analgesia|Paracetamol 1000 mg every 8 hours for the first 24 hours, Ketorolac 30 mg in case of pain control failure (Numeric Rating Scale- NRS>4) which can be administered every 8 hours at most (max 90 mg / 24 hours), Morphine 10-20 mg IV in 24 hours as rescue analgesia.
15834061|NCT04172207|Other|Sampling|After periodontal parameters measured, smear samples were obtained from the buccal mucosa and keratinized gingiva, and then a gingival biopsy was performed from the upper premolars.
15834062|NCT04172181|Procedure|cord blood stem cell transplantation|Unrelated cord blood stem cell selection； Reduced intensity conditioning； GVHD prevention； Infection prevention.
15834063|NCT04172168|Diagnostic Test|Heart rupture|Left ventricular free-wall ruptrue after AMI
15834064|NCT04172129|Device|Total Hip Arthroplasty|
15834065|NCT04172116|Device|Continuous glucose monitoring|see arm/group descriptions
15834066|NCT04172090|Other|Control|Normal physical activity and standard energy intake
15834067|NCT04172090|Other|SIT+E|Reduced physical activity and standard energy intake
15834068|NCT04172090|Other|SIT=E|Reduced physical activity and reduced energy intake
15834069|NCT04172064|Diagnostic Test|Myocardial perfusion scintigraphy|
15834070|NCT04172051|Behavioral|Tony Robbins Date with Destiny|DWD is a 6-day immersive transformational experience led by Tony Robbins. It will be held at the PALM BEACH, FLORIDA Convention Center from December 5th through December 10th. Subjects will be exposed to a variety of mind-body exercises and psychoeducational content including neural linguistic programming, designed to motivate, inspire, and improve the quality of people's lives.
15834071|NCT04172038|Behavioral|Physical Therapy|Physical therapy will be delivered using a guideline-concordant approach based off the Department of Defense -Veterans Affairs Low Back Pain Guidelines, focusing on risk-stratified care deliver (using the STarT Back tool as an adjunct).
15834072|NCT04172038|Behavioral|Move 2 Health (M2H)|"Participants will receive education for self-management (video and written materials) to introduce the key domains of holistic health in the Move to Health (M2H) model and their relationship to chronic LBP. Next, the participant will complete a Personal Health Inventory. The Inventory will be reviewed by the health coach and patient in order to identify specific domains for priority based on patient preference:
~Sleep
~Physical Activity
~Nutrition
~Intrinsic Well-Being (Personal Development, Spiritual Well-Being, Emotional Well-Being)
~Extrinsic Well-Being (Family/Social Relationships, Surroundings)
~Care may range from guided self-management with the researcher to a specialist referral (e.g., sleep specialist, dietician, behavioral health provider, etc.)."
15834073|NCT04172038|Behavioral|MORE Mindfulness|"Throughout the intervention, three core areas are emphasized. Activities include exercises and at-home work for participants to reinforce these core areas.
~Mindfulness
~Cognitive reappraisal
~Savoring of positive experiences"
15834074|NCT04172025|Diagnostic Test|Analysis of Bacterial Genome|genome assembly; prediction of sequence type (MLST); core genome MLST tree to rapidly compare strains within a project; core genome single nucleotide polymorphism (SNP) tree to compare all Swiss Pathogen Surveillance Platform (SPSP) strains belonging to a same species; whole genome SNP tree to compare all SPSP strains within the same species and ST;; prediction of resistance and virulence factors within pathogen submitted genomes; time trees and calculation of transmission rates, including basic reproduction number; analysis of classical epidemiological data with advanced statistical methods including machine learning.
15834184|NCT04171154|Behavioral|Expectation|writing task
15834075|NCT04172012|Biological|Labinic (R) probiotic mixture|Labinic (R) probiotic mixture containing Lactobacillus acidophilus and Bifidobacterium infantis and B. breve
15834076|NCT04172012|Other|Placebo|Placebo mixture
15834077|NCT04171999|Other|Community Rx-Hunger (CRx-H)|"The CRx-H Intervention provides dosages of health content that offer assistance for food insecurity and other health-related social needs. A caregiver randomized to the intervention will receive a hard-copy print-out of their tailored list of resources to address food insecurity. A member of our research team will deliver this list and provide a brief educational component which includes: a brief, structured script about the common problem of food insecurity in households with children and co-occuring HRSNs, review of the resource list which includes nearby, vetted resources to address these needs and coaching on how to activate resources on the list. Prior to discharge, the caregiver will receive a duplicate copy of the list of resources. After discharge, the caregiver will receive text messages at a frequency based on the Critical Time Intervention (CTI) Model, from baseline to 3 months post discharge, in order to receive ongoing support by a research team member."
15834078|NCT04171986|Drug|Mecapegfilgrastim|Mecapegfilgrastim; 6 mg, d7, q3w, total 2 cycles.
15834079|NCT04171973|Device|Driving an electric wheelchair in real condition|For the control group, 3 test circuits of pipes in real condition of increasing difficulty are tested. Patients perform 2 passes in this condition.
15834080|NCT04171973|Device|Driving an electric wheelchair in virtual condition|For the virtual reality group, the circuits have been digitized. Patients perform 2 passes in this condition.
15834087|NCT04171947|Device|Matuzalem ovule|vaginal ovule with 2 mg tea extract
15834088|NCT04171947|Device|Vehicle ovule|polyethylene glycol vaginal ovule
15834089|NCT04171921|Procedure|Robotic ventral hernia repair|Laparoscopic robotically assisted trans-abdominal pre-peritoneal epigastric or umbilical hernia repair with closure of fascial defect and non-adsorbable mesh reinforcement
15834090|NCT04171921|Procedure|Open ventral hernia repair|Standard open pre-peritoneal epigastric or umbilical hernia repair with closure of fascial defect and non-adsorbable mesh reinforcement
15834091|NCT04171908|Other|Conventional therapy|Conventional Physical therapy for the upper limb
15834092|NCT04171908|Other|Nintendo Switch Joy-Con|Conventional Physical therapy for the upper limb plus Nintendo Switch Joy-Con
15834093|NCT04171895|Other|Questionnaires|Will be filled out before and after the training so investigators can evaluate the skills learned and how they can be used them in advanced care planning. Questionnaires will be available in both paper form and electronic via REDCap.
15834094|NCT04171895|Other|Communication training Part 1 (no longer recruiting)|1.5 hour Communication Training will be delivered through videoconferencing using the WebEx or Zoom platforms. The Training consists of a 30-minute lecture watched independently, and two modules (ACP Discussions with your Loved One and ACP Discussions with the Medical Team) completed as part of a virtual meeting. The lecture will be pre-recorded by Drs. Applebaum and Parker and will be sent via REDCap to ICs prior to the training to watch idependently. REDCap will log when ICs watch the lecture so that study staff know the participant has completed this aspect of the training. For the second part of the training ICs will participate in a virtual meeting for approximately 90 minutes of experiential role-play exercises where ICs will practice skills in simulated encounters with actors trained to play patients and HCPs.
15834095|NCT04171895|Other|Enhanced usual care|"Participant will complete a survey on distress and receive feedback about distress and given a resource packet with support information and targeted referrals based on needs. The participant will also receive a physical or electronic copy of a book entitled Cancer Caregiving A to Z published by the American Cancer Society."
15834096|NCT04171895|Other|Communication training Part II|Part II The communication training developed in Part 1 will have two modules (ACP Discussions with your Loved One and ACP Discussions with the Medical Team) and consist of a 20-30 minute lecture and 90 minutes of experiential role-play exercises where ICs will practice skills in simulated encounters with actors trained to play patients and HCPs. Realistic scenarios were created and tailored according to ICs' reported concerns. After training, ICs will be coached through setting a SMART goal related to conducting ACP conversations, which emphasize Specific, Measurable, Attainable, Relevant and Time-bound steps that motivate and direct behavior change. Two weeks post training, a booster phone call will be made to ICs to check progress toward their SMART goal, address barriers with problem-solving and review skills as indicated.
15834097|NCT04171869|Other|no intervention|observational study, no intervention
15834099|NCT04171843|Genetic|PBCAR269A|Allogeneic anti-BCMA CAR T-cell
15834100|NCT04171843|Drug|Fludarabine|Fludarabine is used for lymphodepletion.
15834101|NCT04171843|Drug|Cyclophosphamide|Cyclophosphamide is used for lymphodepletion.
15834102|NCT04171843|Drug|Nirogacestat|Allogeneic anti-BCMA CAR T-cell
15834185|NCT04171154|Behavioral|Acceptance|listening
15834186|NCT04171141|Drug|PF-07062119|PF-07062119
15834187|NCT04171141|Drug|Anti-PD1|Anti-PD1 PF-06801591
15834188|NCT04171141|Drug|Anti-VEGF|Anti-VEGF IV (bevacizumab)
15834189|NCT04171128|Behavioral|antibiotic stewardship efforts|The local antibiotic team plan to implement procalcitonin use among the hospital physicians. the interventions are not ready yet.
15834192|NCT04171102|Device|ProFlor Hernia implant|Inguinal hernia repair
15834103|NCT04171830|Other|modified Hospital One-year Mortality Risk (mHOMR)|"Every inpatient will automatically be given the intervention (an mHOMR/HOMR Now! score) upon admission to hospital and considered for secondary interventions based on their score. Baseline threshold will be set as >0.21 (59% sensitivity and 90% specificity for 12-month mortality with mHOMR).
~At minimum each individual identified by the tool will receive two assessments to screen for severe symptoms and desire to engage in advance care planning (ACP):
~Edmonton Symptom Assessment System Revised: scores >6 will be flagged as severe. Clinical teams will address the symptoms as appropriate for the patient.
~4-item Advanced Care Planning Engagement Survey: Scores of 3-4 indicate readiness to discuss ACP. Clinical teams may choose to discuss ACP and goals of care themselves, activate a local ACP intervention, or distribute ACP documentation.
~Both of these assessments will be done by a member of the treating team within 72 hours of the patient's hospital admission."
15834104|NCT04171817|Drug|Chlorhexidine|The goal of this work is to assess the effect of chlorhexidine (CHX)-based interventions--specifically use of pre-session chlorhexidine shampoo for the dog and use of chlorhexidine wipes on the dog's fur--on patient exposure to hospital-associated pathogens during the sessions with the dogs
15834105|NCT04171804|Device|Transcranial direct current stimulation|Participants will receive a total of 10 stimulation sessions on 5 consecutive days (twice a day with 3-4 hours interval). During each session, 2 milliAmpers (mA) of active or sham tDCS will be applied for 20 minutes over the dorsolateral prefrontal cortex (left anodal/right anodal).
15834106|NCT04171791|Drug|ABT-199 (venetoclax)|Eligible patients will be enrolled into the study and receive venetoclax daily per the US FDA package insert guidelines of venetoclax, with dose escalation up to 400 mg. To minimize the risk of tumor lysis syndrome (TLS), and following the package insert directions for dose escalation over 5 weeks, the initial dose is 20 mg daily, and may be progressively increased as tolerated to 400 mg by week 5.
15834107|NCT04171778|Other|whole food, plant-based diet|The study diet is whole food, plant based defined as containing no animal products or refined grains or added oils, minimal use of any sweeteners, and, for the purposes of this study, on average containing no more than 15% calories from fat.
15834110|NCT04171752|Drug|elafibranor|elafibranor 120mg is a coated tablet for oral administration
15834111|NCT04171739|Drug|Itraconazole oral solution|200 mg once daily on Days 6 to 15
15834112|NCT04171739|Drug|Rifampicin Oral Capsule|600 mg once daily on Days 6 to 15
15834113|NCT04171739|Drug|Olorofim|Single oral dose on Days 1 and 11
15834114|NCT04171726|Drug|Edoxaban|A non-vitamin K antagonist (VKA) oral anticoagulant that selectively inhibits factor Xa.
15834115|NCT04171713|Behavioral|Mindfulness-Based Health Promotion + Treatment as usual|Structured and developed over eight weeks (8 sessions), participants meet weekly for an average of 2 hours to experience the techniques and conceptual learning about mindfulness and can be adapted to one or 1.5 hour sessions. to be applicable within the contexts of health, education, and organizations. Plus participation in support groups offered by the bariatric surgery clinic with capacity for 40 participants, monthly attendance and duration of 2 hours. In these meetings, there is always the presence of a surgeon, a psychologist and another invited professional (endocrinologist, nutritionist, speech therapist or dentist), who give a thematic lecture and then there is the opening space for doubts and exchange of experiences.
15834116|NCT04171713|Behavioral|Attachment-based compassion therapy + Treatment as usual|It is a program based on one of the fundamental psychological constructs that explain individuals' interpersonal relationships, attachment styles. It lasts 8 weeks in which participants meet for 2 or 2.5 hours at each meeting.
15834117|NCT04171713|Behavioral|Treatment as usual|participation in support groups offered by the bariatric surgery clinic with capacity for 40 participants, monthly attendance and duration of 2 hours. In these meetings, there is always the presence of a surgeon, a psychologist and another invited professional (endocrinologist, nutritionist, speech therapist or dentist), who give a thematic lecture and then there is the opening space for doubts and exchange of experiences.
15834118|NCT04171700|Drug|Rucaparib|Oral rucaparib will be administered twice daily. The starting dose will be 600 mg daily (BID).
15834119|NCT04171687|Drug|Clopidogrel 75mg|Clopidogrel 75 mg tablet
15834120|NCT04171687|Drug|Tegoprazan 50 mg|Tegoprazan 50 mg tablet
15834121|NCT04171687|Drug|RAPA113|RAPA113 tablet
15834122|NCT04171674|Drug|Treatment with high-dose ceftobiprole (500mg loading dose followed by 2.5g under continuos infusion).|High-dose ceftobiprole (500mg loading dose) will be administered to patients for 30 minutes followed by 2.5g under continuous infusion for 24 hours.
15834123|NCT04171661|Biological|SASS|SASS applied on chronic skin wounds as skin graft
15834124|NCT04171648|Other|Roasted Peanut Treatment|The subjects will consume 2 ounces or ~48 grams of roasted in shell peanuts a day for two weeks.
15834125|NCT04171648|Other|Boiled Peanut Treatment|The subjects will consume 2 ounces or ~48 grams of boiled peanuts a day for two weeks.
15834126|NCT04171635|Radiation|Quantitative Susceptibility Mapping (QSM) Magnetic Resonance Imaging (MRI)|Investigators will validate hepatic QSM (hQSM) using histological examination and chemical measurement of liver iron concentration (LIC). Patients will undergo clinical MRI in Aim 1. In patients with increased LIC their liver explants will undergo MRI, pathological examination, and chemical determination of the LIC.
15834127|NCT04171635|Radiation|R2* Magnetic Resonance Imaging (MRI)|Investigators will be able to validate hQSM in measuring liver iron concentration (LIC) by comparing it to this traditional MRI technique
15834128|NCT04171622|Drug|Lenvatinib|Given PO
15834129|NCT04171622|Biological|Pembrolizumab|Given IV
15834130|NCT04171609|Behavioral|Expressive writing|During this daylong expressive writing workshop intervention, the writing instructor coached participants through a series of simple writing exercises. Participation required neither any prior writing experience, nor any desire to become a writer. The practices cultivate natural abilities to express the ideas that define who you are and how you experience your life.
15834193|NCT04171089|Behavioral|Child- Safety Plan Intervention|The intervention includes recognizing and knowing the individual's warning signs for a suicidal crisis, their personal coping/distraction skills, people to contact, as well as a restriction of the means to hurt oneself.
15834194|NCT04171076|Procedure|Transcutaneous spinal cord stimulation|Theta burst stimulation at thoracic level (T5) over 2 minutes
15834131|NCT04171596|Behavioral|Primary care coordination|"A registered nurse currently employed at Duke Integrative Medicine, who is also trained as an integrative health coach, will serve in the PCC role. The intervention will flow as follows:
~The PCC will call study participants every 2 months during the 6 months (more frequently as needed) for a semi-structured phone check-in, and will track the intervention through the REDCap database. The PCC will use guiding questions to frame the call, but will also:
~Respond Ask follow-up questions Provide suggestions that are guided by the patient response and appropriateness to the individual situation and needs and scope of practice.
~Prior to the call, the PCC will review the patient chart to see if any outstanding orders, medical visits due, and review the patient health goals (known as the pre-work).
~The PCC will call the patient to provide intervention. If patient is not available, the PCC will leave a message, or contact via MyChart to see about scheduling a time to talk."
15834132|NCT04171570|Procedure|Coronary angiography and or Percutaneous coronary Intervention|Radial access punture site
15834133|NCT04171557|Behavioral|Bicycling|Total bicycling is reported in categories of: (0 - reference), (>0 to <60), (≤60 to >150), (≤150 to < 300) and (≥300) minutes/week
15834134|NCT04171544|Device|Streamline Occipito-Cervico-Thoracic Spinal Fixation System|Spinal Fixation
15834135|NCT04171531|Drug|Botox® injection|Botulinum toxin A will be prepared by dissolving 100 units of botulinum toxin A into 10 ml of injectable saline. Indigo carmine or methylene blue 0.1 ml will be added to each syringe of botulinum toxin A. The treating physician will inject a total of 10 ml of the Botox A® into approximately 15 to 20 different detrusor muscle sites under direct visualization.
15834136|NCT04171531|Device|Mid-urethral sling|"Mid-urethral Sling Procedure includes retropubic as well as transobturator full length slings. Mini-sling and single-incision sling will not be allowed due to potential risk for higher failure rate."
15834137|NCT04171518|Device|Catalys Precision Laser System|Cataract surgeons to create a precise anterior capsulotomy and/or subsequent fragmentation (phacofragmentation) of the crystalline lens using the Catalys Precision Laser System
15834138|NCT04171505|Drug|HPV vaccine|". Patients diagnosed with HSIL / CIN 2+ who met the inclusion criteria were submitted to cervical conization and subsequently enrolled in the study after signing the informed consent, approved by ethics commission.
~We will take into account the date of administration of the first dose of vaccine. The types of vaccines administered can be: Bivalent vaccine (includes genotypes 16/18), Tetravalent (includeds genotypes 6, 11, 16 and 18) both funded in the region in different years, or not funded (Nonavalent vaccine; includes genotypes: 6, 11, 16, 18, 31, 33, 45, 52 and 58). To define the time of vaccination around the conization date, the administration of the first dose of vaccine will be taken into account."
15834139|NCT04171479|Device|Epicardial mapping and/or ablation|Either catheter mapping, ablation, or mapping and ablation will be performed using an epicardial catheter approach.
15834140|NCT04171466|Other|Ciprofloxacin + Metronidazole|Participants will be instructed to take 1 capsule of Ciprofloxacin (500mg) twice daily for 7 days and 1 capsule of Metronidazole (500mg) thrice daily for 7 days. Antibiotics should be taken at least 2 hours before or 6 hours after mineral supplements containing magnesium or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc.
15834141|NCT04171466|Other|SH-DS01|SH-DS01 is a rationally defined microbial consortia consisting of 24 strains across 12 species, with polyphenolic and phenolic prebiotic bioactive compounds. Participants will be instructed to take 2 capsules daily for the duration of the trial.
15834142|NCT04171466|Other|Placebo|Placebo capsules for SH-DS01 will contain rice flour matched for color and texture in an identical outer capsule shell. Participants will be instructed to take 2 capsules daily for the duration of the trial.
15834143|NCT04171453|Drug|Lyrica CR (Pregabalin)|Lyrica CR 82.5mg, 165mg, or 330mg OD
15834144|NCT04171440|Procedure|minimally invasive pancreaticoduodenectomy|The minimally invasive pancreaticoduodenectomy is performed through small incisions using robotic-assisted technology or endoscopic techniques. Pancreaticoduodenectomy is the operation that is necessary to remove tumors of the head and neck of the pancreas, lower portion of the bile duct, and the ampulla of Vater.
15834145|NCT04171440|Procedure|open pancreaticoduodenectomy|Open pancreaticoduodenectomy is considered the current standard of care. Pancreaticoduodenectomy is the operation that is necessary to remove tumors of the head and neck of the pancreas, lower portion of the bile duct, and the ampulla of Vater
15834146|NCT04171427|Other|Lithium liposome|Cosmetic product
15834147|NCT04171427|Other|Placebo|Cosmetic product vehicle
15834148|NCT04171414|Biological|CT-P17 SC AI (adalimumab)|Subcutaneous Injection of Adalimumab 40mg once every two weeks
15834149|NCT04171401|Other|In-patient stroke rehabilitation.|An in-patient multi-disciplinary stroke rehabilitation program was performed.
15834150|NCT04171388|Drug|Azithromycin 500 mg|Azithromycin 500mg (Kern Pharma): 2g (4 tablets) at 2 time points during pregnancy: enrollment (<=24 weeks gestation), and follow-up ANC at least 4 weeks later
15834151|NCT04171388|Dietary Supplement|Multiple Micronutrient or Fortified Balanced Energy Protein Supplement|Daily multiple micronutrient (MMN) tablet (Contract Pharmacal Corp) for women with mid-upper arm circumference (MUAC) >=23 cm, OR Daily fortified balanced energy protein (BEP) supplement (DSM South Africa; Faffa Food Products): Fortified corn-soy blend (784 kcal/day) for women with MUAC <23 cm
15834152|NCT04171388|Drug|Placebo oral tablet 500 mg|Placebo 500mg (Idifarma): 2g (4 tablets) at 2 time points during pregnancy; enrollment (<24 weeks gestation), and follow up ANC at least 4 weeks later
15834153|NCT04171388|Other|Enhanced Infection Management Package (EIMP)|"ENROLLMENT VISIT: Screening for bacteriuria with urine culture, and antimicrobial susceptibility testing; Screening for chlamydia and gonorrhea with Cepheid GeneXpert; Presumptive deworming with albendazole 500mg.
~FOLLOWUP TREATMENT VISIT: For women with identified urinary tract infection or asymptomatic bacteriuria, treatment with antibiotics based on antimicrobial susceptibility patterns. For women with identified chlamydia or gonorrhea, treatment of woman (and partner) with appropriate antibiotics. Test of cure sample and retreatment of infection.
~Second deworming with albendazole at least 4 weeks after enrollment ANC visit."
15834195|NCT04171063|Device|Thoracic compressor|The intervention is the use of the thoracic compressor for the conservative treatment of pectus carinatum
15834196|NCT04171050|Drug|Local anaesthetic|Local anesthesia injections
15834197|NCT04171050|Drug|Pudendal Nerve Block plus anesthesia|Local anesthesia injections plus a pudendal nerve block
15834198|NCT04171037|Procedure|Oxygen Therapy|Receive oxygen via Optiflow THRIVE
15834154|NCT04171375|Device|trans-spinal Electrical Stimulation (tsES)|The trans-spinal pulsed-current stimulation utilizes non-invasive russian stimulation using a research grade stimulator and direct-current stimulation utilizes non-invasive constant stimulation using a medical grade stimulator. Both pulsed- and direct-current stimulation will be achieved with cutaneous cathode electrodes attached to the dorsal aspect of the back overlying at and bellow thoracic vertebrae and anode electrodes placed over the iliac crests or lower abdomen. Spinal motor evoked potentials will be induced by trans-spinal pulsed-current stimulation (parameters, 1 Hz with a 1 millisecond pulse width and monophasic waveform) to determine recruitment profiles of proximal and distal motor pools with increasing stimulation intensity ranging from 10-200 milliampere. Stimulation parameters for the therapeutic stimulation will be ranged from 5-50 Hz and 20-200 milliampere. For direct-current stimulation, the stimulation current will be kept constant at 2-2.5 milliampere.
15834155|NCT04171362|Other|Connective Tissue Massage|Connective tissue massage (CTM) is a manipulative technique that facilitates the diagnosis and treatment of a wide range of pathologies. Observation and subsequent manipulation of the skin and subcutaneous tissues can have a beneficial effect upon tissues remote from the area of treatment.
15834156|NCT04171362|Other|Education|Education patients were informed about migraine triggers, migraine prevention and coping strategies and exercise options. The exercises were demonstrated by the physiotherapist
15834157|NCT04171349|Drug|Articaine|Vial
15834158|NCT04171349|Drug|Dexmedetomidine|Vial
15834159|NCT04171336|Behavioral|Animal-assisted therapy|Six sessions of animal-assisted intervention for children and adolescents, group format. The sessions will focus on psycho-education on pain, mindfulness, defocusing, getting active, and resources. Additionally, the intervention includes two family visits.
15834160|NCT04171323|Behavioral|Cognitive Training|Participants will be completing a total of 40 computerized sessions.
15834161|NCT04171323|Behavioral|Computerized Cognitive Stimulation|Participants will be completing a total of 40 computerized cognitive stimulation sessions.
15834162|NCT04171310|Drug|SAR442168|Pharmaceutical form:oral solution Route of administration: Oral
15834163|NCT04171297|Procedure|Ultrasound evaluation of DE|To evaluate diagnostic accuracy of ultrasound for the presence of deep endometriosis.
15834164|NCT04171284|Drug|SCT-I10|200 mg, Q3W, maximum treatment up to six cycles
15834165|NCT04171284|Drug|Docetaxel|70-75mg per square meters of body surface area, Q3W, maximum treatment up to six cycles
15834166|NCT04171284|Drug|Placebo|200 mg, Q3W, maximum treatment up to six cycles
15834167|NCT04171271|Behavioral|Activating kinesthetic motor imagery training|Participants in the activating kinesthetic motor imagery training group will imagine high effort exercises (e.g. planking, boxing, jumping, squats, push-ups) in the sessions in home using the study audio-video motor imagery script for 5 times per week; 17 min per day for 2 weeks. Phone calls will be performed for support and as a reminder for the assessment (after one week).
15834168|NCT04171271|Behavioral|Relaxing kinesthetic motor imagery training|Participants in the relaxing kinesthetic motor imagery training group will imagine relaxing (low effort) exercises (e.g. breathing exercises, stretching, body awareness exercises) in home using the study audio-video motor imagery script 5 times per week; 17 min per day for 2 weeks. Phone calls will be performed for support and as a reminder for the assessment (after one week).
15834169|NCT04171258|Drug|Botulinum toxin type A injection|Experimental
15834170|NCT04171258|Drug|Botulinum Toxin Type A Injection [Botox]|Active Comparator
15834171|NCT04171245|Other|Laughie laughter prescription|Creation of a Laughie; laughing with their Laughie 3x a day
15834172|NCT04171245|Device|Sleep tracking equipment|Tracking sleep using equipment
15834173|NCT04171232|Other|Balance It|Each patient in group 1 i.e. Balance It group would be given a 15 minutes long session. Each session would start in standing position and the patient would play the game while they would be instructed to balance the objects falling from above on the imaginary bar (and an actual bar at later stages) held with their both hands, and not let those objects fall by opening their arms wide open and by staying or moving according to the target spot for the set time. This session would be repeated three times a week for two months (total 12 sessions/month).
15834174|NCT04171232|Other|Bubble Pop|Each patient in group II i.e. Bubble Pop group would be given a 15 minutes long session. Each session would start in standing position and the patient would play the game while they would be instructed to reach for the balloons coming from random directions and pop them by moving their upper limbs and even their whole body if required. They would also be instructed to avoid a specific object that would result in deduction of their overall game score. This session would be repeated three times a week for two months (total 12 sessions/month).
15834175|NCT04171232|Other|Scoop'd|Each patient in group III i.e. Scoop'd group would be given a 15 minutes long session. Each session would start in standing position and the patient would play the game while they would be instructed to hold an imaginary ice cream cone (and an actual basket designed similar to an ice cream cone in later stages) with their both hands and move to catch the ice cream scoops falling at random spots from above, one spot at a time. They would also be instructed to avoid a specific object that would result in deduction of their overall game score. This session would be repeated three times a week for two months (total 12 sessions/month).
15834176|NCT04171219|Biological|Pembrolizumab|Given IV
15834177|NCT04171219|Drug|Talabostat Mesylate|Given PO
15834178|NCT04171206|Other|Free From Abuse|Participants in the treatment arm will watch a 15-minute talk given by an adult female survivor of IPV who tells the story of her abusive relationship. After watching the video, participants will read information on 10 signs of an unhealthy relationship. The intervention will take approximately 25 minutes to complete.
15834179|NCT04171206|Other|Technology and crime|Participants in the placebo control arm will watch a 19-minute talk on technology development and crime. After watching the video, participants will read 10 facts about cyber security. The intervention will take approximately 25 minutes to complete.
15834180|NCT04171193|Drug|Isoflurane|Deep anesthesia with isoflurane to achieve burst suppression pattern for more than 80% of the time for 15 minutes measured in electroencephalogram and Bi-Spectral Index
15834181|NCT04171193|Drug|Sertraline Pill|Patients that did not respond to Isoflurane treatment, will star on sertraline to evaluate any enhancement in antidepressant efficacy after pre-treatment with isoflurane
15834182|NCT04171180|Drug|budesonide/formoterol|apply different dosage of budesonide/formoterol in two groups and evaluate the treatment effects.
15834202|NCT04171024|Device|Sham electrical stimulation|A non invasive sham diaphragm electrical stimulation using transcutaneous thoracic probes
15834203|NCT04171024|Device|Transcutaneous diaphragm electrical stimulation|A non invasive diaphragm electrical stimulation using transcutaneous thoracic probes
15834204|NCT04171011|Device|Stimulator device|The stimulator device will be used to electrically stimulate the NVB
15834205|NCT04170998|Drug|Evogliptin 5mg|Participants receive Evogliptin 5mg orally once a day
15834206|NCT04170998|Drug|Evogliptin Placebo|Participants receive placebo to match Evogliptin 5mg orally once a day
15834207|NCT04170998|Drug|Dapagliflozin 10mg|Participants receive Dapagliflozin orally once a day
15834208|NCT04170998|Drug|Metformin ≥ 1000mg|Metformin are administered at the same dose and formulation.
15834210|NCT04170972|Other|Acute exercise|One hour of acute one-legged knee-extensor exercise followed by 3 hours recovery and 2 hours insulin (1.5 mU/min/kg) stimulation.
15834211|NCT04170959|Drug|Metformin|Metformin 500 mg given 14 days before start until the end of radiation therapy. Once daily during the first 7 days, afterwards twice daily until the end of treatment.
15834212|NCT04170959|Other|No metformin|Standard of care without metformin.
15834213|NCT04170946|Other|Talazoparib in Combination with Low Dose Radiotherapy (RT)|Dose escalation model to determine the safety and MTD of talazoparib in combination with low dose RT.
15834214|NCT04170933|Procedure|Magnetic recanalization|"Establish a percutaneous transhepatic cholangio drainage (PTCD) fistula.
~Perform endoscopic sphincterotomy (EST).
~Place one magnet above the stricture through the PTCD fistula.
~Introduce another magnet below the stricture through the common bile duct with ERCP.
~Place the magnets at the appropriate point to attract each other.
~The patient will be strictly followed, and the magnets will be taken out out of the mouth by the thread connected with the magnets.
~A plastic stent will be placed in the bile duct for lasting support."
15834215|NCT04170920|Device|LifeExtend-AI|"LifeExtend-AI (LX-AI) will be piloted by adding AI- specific features to LifeExtend, an already existing healthy lifestyle behavior application produced by LifeOmic. This application includes features for tracking activity, diet, sleep, and body weight, as well as creating to-do lists and participating in closed social networking for support and encouragement. LifeExtend-AI will add features to track AI adherence and patient-reported joint pain, with alerts sent to both the participant and the healthcare team in response to these parameters. In addition, the app contains educational videos and articles, to which articles addressing management of AI- related toxicities (including exercise) will be added."
15834216|NCT04170907|Other|standardized vaping protocol|The following questionnaires will first be completed: Modified Minnesota Nicotine Withdrawal Scale, Tiffany Questionnaire on Smoking Urges-Brief total (global) craving score, Positive and Negative Affect Schedule. The assigned product will then be given to the participant, and one puff will be taken every 30 seconds (total of 10 puffs). Blood samples will be collected 15 minutes before vaping and 2, 5, 15, 30, 60, 120, and 180 minutes after the last puff. Heart rate and blood pressure will be measured 15 minutes before and 2, 10, 15, 30, 60, 120, and 180 minutes after the last puff. Post-use withdrawal, craving, reward, and satisfaction will be assessed 10 minutes and 1 and 3 hours after the last puff. Respiratory Symptoms will be assessed at baseline and 5 minutes after the last puff. Ten minutes post-use, the direct effects will also be assessed.
15834219|NCT04170881|Other|Exposed/non exposed - Epidemiology|visit of daycares and environmental measurement will be performed
15834220|NCT04170868|Other|ADHD Psycheducation|The videos will disseminate evidence-based strategies for the management of Attention Deficit Hyperactivity Disorder (ADHD). Each video, roughly two minutes, will both introduce the viewer to a single ADHD management strategy and explain how said strategy can effectively be integrated into their life.
15834221|NCT04170855|Drug|Furosemide Injection|"We will measure kidney sodium content in patient with cardiorenal syndrome. we will inject within the week of this first measurement furosemide only in patient who will be resistant to diuretics (Based on these parameters, diuretic response will be defined as:
~A reduction in fractional spot urinary sodium
~An increase in urinary volume
~A >1 kg reduction in body weight within 24 hours from diuretic administration (extrapolation of guidance on management of acute HF) and we will do another measurement of kidney sodium content after furosemide injection."
15834222|NCT04170842|Other|Music intervention|Participants will work with the music therapist to make their selections. Music therapists will provide input on how best to synchronise type, tempo and genre of music to the wound dressing procedure. As musical preference is very personal, the choice of music provided will try to strike a balance of providing what is acceptable to patients while not exposing them to music with known stimulatory effects.
15834223|NCT04170829|Biological|ChAdOx1 MERS|a replication-deficient simian adenoviral vector expressing the spike (S) protein of MERS Coronavirus.
15834224|NCT04170816|Device|Dry needling|DN and KT therapy will be applied 3 sessions in 1-week intervals
15834225|NCT04170803|Device|Dry Needling|The participant will undergo true or sham dry needling treatment with simultaneous monitoring using the NIRS head cap.
15834226|NCT04170803|Other|Sham Dry Needling|"The participant randomized to the sham group will undergo placebo dry needling which is functionally mimicking trigger point dry needling"
15834227|NCT04170790|Drug|Saxagliptin 5mg|Saxagliptin 5mg oral tablet
15834228|NCT04170790|Drug|Sildenafil 50 mg|Sildenafil 50 mg Oral Tablet
15834229|NCT04170751|Drug|16 mcg / cc of norepinephrine(group N)|In group N, 16 mcg / cc of norepinephrine was infused through the central catheter. Drug titration should be 0.05 mcg / min / kg for norepinephrine and 2 units / hr for vasopressin, until target blood pressure is reached. Drug infusion rate should not exceed 0.3mcg / min / kg for norepinephrine and 10unit / hr for vasopressin for patient's safety.
15834230|NCT04170751|Drug|0.4 unit / cc of vasopressin(group V)|In group V, 0.4 unit / cc of vasopressin was infused through the central catheter and the respective doses recorded. Drug titration should be 0.05 mcg / min / kg for norepinephrine and 2 units / hr for vasopressin, until target blood pressure is reached. Drug infusion rate should not exceed 0.3mcg / min / kg for norepinephrine and 10unit / hr for vasopressin for patient's safety.
15834232|NCT04170725|Other|Patient and Healthy Volunteers training protocol|Patients and Healthy Volunteers will undergo a 14-day endurance training protocol. No study drugs will be administered. Patients and Healthy Volunteers will be instructed regarding their training protocol. Training sessions will be undertaken on days 1, 3, 5, 7, 9 and 11 after the first examination day. Patients and Healthy Volunteers will be asked to contract their TA muscle repeatedly by pulling the right foot towards the head in a standing position while the heel remains on the ground (at 5 second intervals). In order to carry out the training they will also receive a video demonstrating the exercise. On days 1 and 3 they will do the exercise for 5 minutes, on days 5 and 7 for 10 minutes and on days 9 and 11 for 15 minutes.
15834233|NCT04170712|Other|Tampons|Collection of tampons, blood, cervical swabs, tissue and ascites
15834234|NCT04170699|Procedure|Port-a-cath replacement|Implantation of a subcutaneous venous port-a-cath
15834235|NCT04170686|Behavioral|Zemedy App for Irritable Bowel Syndrome|The Zemedy App for irritable bowel syndrome is designed to be an engaging, self-help app for people with irritable bowel syndrome. It is based on empirically supported cognitive-behavioral, and GI focused hypnotherapy interventions for IBS.
15834236|NCT04170660|Diagnostic Test|Diagnostic test|During a vascular check-up usually prescribed, an additional blood sample is taken to allow the determination of the sFlt1/PlGf ratio.
15834237|NCT04170647|Drug|Plasminogen Activators|standard dosage of 0.9 mg/kg or reduced dosage of 0.6 mg/kg, divided into a 15% bolus and an 85% venous infusion
15834238|NCT04170634|Other|Evaluation of the fracture risk using data from routine qCT (quantitative Computed Tomography) scan and numerical simulation|Assessment of the mechanical tumor bone strength by numerical simulation using qCT routine imagery of proximal femur (applying a monopodal standing load) and vertebrae (applying a uniaxial compression load).
15834239|NCT04170621|Device|Ablation|Ablation using the FARAPULSE Endocardial Multi Ablation System
15834240|NCT04170608|Device|FARAPULSE Endocardial Multi Ablation System|Ablation using the FARAPULSE Endocardial Multi Ablation System
15834241|NCT04170595|Biological|GB221,2 mg/kg|Single dose, 2mg/kg group: lyophilized powder of Coprelotamab Injection; strength 110mg/bottle; 2 mg/kg for one dose, intravenous infusion, completed for over 90 minutes
15834242|NCT04170595|Biological|GB221,6 mg/kg|Single dose 6mg/kg group: lyophilized powder of Coprelotamab Injection; strength 110mg/bottle; 6 mg/kg for one dose, intravenous infusion, completed for over 90 minutes
15834243|NCT04170595|Biological|Herceptin,6 mg/kg|Single dose group: lyophilized powder of Trastuzumab Injection; strength 440 mg/bottle; 6 mg/kg for one dose, intravenous infusion, completed for over 90 minutes
15834244|NCT04170595|Biological|GB221,8mg/kg|Single dose 8mg/kg group: lyophilized powder of Coprelotamab Injection; strength 110mg/bottle; 8mg/kg for one dose, intravenous infusion, completed for over 90 minutes
15834245|NCT04170595|Biological|GB221:2mg/kg and Capecitabi:1000mg/kg|GB221:Lyophilized powder of Coprelotamab Injection; strength 110mg/bottle; 2mg/kg, the first infusion is completed over 90 minutes. If no serious adverse reaction is observed, the subsequent infusion can be completed over 30 minutes. The administration shall be continued until disease progression or intolerable toxic reactions or ICF withdrawal of subjects. Multiple dose group; Capecitabine:1000mg/kg, orally twice daily (one dose each in the morning and evening; total daily dose of 2000 mg/m2), administration for 2 weeks followed by a 1-week rest period, as a 3-week cycle.
15834246|NCT04170595|Biological|Herceptin:2mg/kg and Capecitabin:1000mg/kg|Herceptin:Lyophilized powder of Trastuzumab Injection; strength 440 mg/bottle; 2mg/kg, the first infusion is completed over 90 minutes. If no serious adverse reaction is observed, the subsequent infusion can be completed over 30 minutes. The administration shall be continued until disease progression or intolerable toxic reactions or ICF withdrawal of subjects. Multiple dose groups; Capecitabine:1000mg/kg, orally twice daily (one dose each in the morning and evening; total daily dose of 2000 mg/m2), administration for 2 weeks followed by a 1-week rest period, as a 3-week cycle.
15834247|NCT04170569|Behavioral|Yoga|Yoga Practice and Program: Yoga practice consisted of 10 weeks. Yoga practice involved following stages; 5-minute breathing exercises in standing or sitting position, 40-minute postpartum period specific asanas and last 15- minute deep relaxation in lying position were made by the researcher.
15834248|NCT04170556|Drug|Regorafenib|Regorafenib 160 mg/day 3 weeks on and 1 week off
15834249|NCT04170556|Drug|Nivolumab|Nivolumab at the dose of 1.5 mg/kg, 3 mg/kg or 240 mg/infusion every 2 weeks. Dose will be adjusted depending on the incidence of adverse events
15834253|NCT04170530|Drug|mFOLFOXIRI|irinotecan* 135 mg/m² + oxaliplatin 68 mg/m² + leucovorin 400 mg/m² + 5-FU 2400 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle
15834254|NCT04170517|Diagnostic Test|Measurement of serum progesterone on the day of FET|Measurement of serum progesterone on the day of FET
15834255|NCT04170504|Drug|Qing Re Huo Xue (QRHX)|Qing Re Huo Xue (QRHX) XXmg bid for 24 weeks
15834256|NCT04170504|Drug|Methotrexate|Oral methotrexate 10 mg per week for 24 weeks.
15834257|NCT04170504|Drug|dummy Qing Re Huo Xue (QRHX)|dummy Qing Re Huo Xue (QRHX) XXmg bid for 24 weeks
15834258|NCT04170491|Diagnostic Test|Continuous EEG|Continuous EEGs will be performed with 21 electrodes and polygraphy (ECG and EMG) placed according to the international 10-20 system. In case of extensive neurosurgical defects, a reduced montage may be applied in patients from either group. This information will be added in CRF. The reduced montage in these cases is not expected to reduce the diagnostic accuracy and the outcome, as the neurophysiological changes are generally diffuse and will be detected by adjacent electrodes.
15834260|NCT04170465|Drug|Metformin Hydrochloride 850 mg Tablets|Oral administration of Metformin hydrochloride 850 mg tablets (1700 mg/day) daily until the completion of neoadjuvant chemotherapy cycles
15834261|NCT04170465|Drug|AC-T chemotherapy regimen|AC: (Doxorubicin 60 mg/m2 IV + cyclophosphamide 600 mg/m2 IV) for 4 cycles every 3 weeks followed by Taxol cycles (Paclitaxel 80 mg/m2 IV) once weekly for 12 weeks.
15834285|NCT04170244|Other|Skin swab|Skin will be swabbed to collect samples for bacterial analysis
15834286|NCT04170192|Procedure|Cord Blood Stem Cell Transplantation|Unrelated cord blood stem cell selection; Reduced intensity conditioning regime; GVHD prevention; Infection prevention.
15834262|NCT04170452|Procedure|liver biopsy|Pre-procedure assessment of the liver with ultrasound should be performed for planning positioning and needle entrance point. Supine, oblique, or total left lateral decubitus are the possible positioning of the patient - it is important to make sure that the patient is comfortable and can remain still in that position. Assessing if the procedure will be performed under breath held and practice this with the patient. Marking of the entrance point on the skin is advised to aid the skin cleaning and dressing. A time-out should be performed by this stage. Skin site is prepped and draped to ensure asepsis. Ocal anaesthesia is infiltrated under the skin abdominal wall/intercostal space until the liver capsule. Entrance point is created with a scalpel. Using the freehand technique the needle is advanced under ultrasound guidance during the entire course of the biopsy. The needle tip must always cross the capsule prior to deploying the cutting device.
15834263|NCT04170439|Drug|Clomiphene plus metformin plus N acetyle cysteine in arm number 1|oral adminstration of clomiphene citrate plus metformin plus N acetyl cysteine or chromium
15834264|NCT04170439|Drug|Clomiphene citrate plus metformin with chromium|oral adminstration of clomiphene citrate plus metformin and chromium
15834265|NCT04170439|Drug|clomiphene citrate plus metformin|oral adminstration of clomiphene citrate plus metformin
15834266|NCT04170426|Biological|autologous adipose derived stem cells|Culture expanded mesenchymal stem cells isolated from patient's own abdominal fat tissue
15834267|NCT04170413|Drug|CeVUS|Contrast enhanced voiding urosonography
15834268|NCT04170387|Other|Relaxometer|Day 1: signing of informed consent, medical history, physical examination, Mini-Mental State Examination (MMSE), Fibromyalgia Impairment Questionnaire revised (FIQ-R), repetition of 6 minutes relaxometer pre-set programme for 3 times Day 2: repetition of 6 minutes relaxometer pre-set programme for 3 times Day 3: repetition of 6 minutes relaxometer pre-set programme for 3 times Day 8: 6 minutes relaxometer pre-set programme once Day 10: 6 minutes relaxometer pre-set programme once, Mini-Mental State Examination Day 30: Mini-Mental State Examination (MMSE), Fibromyalgia Impairment Questionnaire revised (FIQ-R)
15834269|NCT04170374|Other|Routine medical record data collection|The study will collect routine medical record data from the electronic medical record system, other electronic databases, and paper charts.
15834270|NCT04170374|Other|Interviews with service providers|Clinicians and lay staff will be interviewed regarding the ART initiation process.
15834271|NCT04170361|Other|Conventional Chest Physiotherapy|All patients will be admitted to physiotherapy rehabilitation program including breathing exercises, modified postural drainage and percussion, lower-upper extremity mobilization exercises and posture exercises once a day during hospitalization. In addition, patients in the education group will be taught the use of Triflo ® and administered at two-hour intervals. The program will be started within the first 24 hours and blood pressure, heart rate, oxygen saturation and respiratory frequency will be recorded before and after the sessions. The values obtained from the second session of the patients will be included in the analysis.
15834272|NCT04170361|Other|Conventional Chest Physiotherapy+Incentive Spirometry|All patients will be admitted to physiotherapy rehabilitation program including breathing exercises, modified postural drainage and percussion, lower-upper extremity mobilization exercises and posture exercises once a day during hospitalization. In addition, patients in the education group will be taught the use of Triflo ® and administered at two-hour intervals. The program will be started within the first 24 hours and blood pressure, heart rate, oxygen saturation and respiratory frequency will be recorded before and after the sessions. The values obtained from the second session of the patients will be included in the analysis.In addition, patients in the education group will be taught the use of Triflo ® and administered at two-hour intervals.
15834273|NCT04170348|Drug|Daily oral vitamin D3, 3,333 IU|Oral vitamin D3, 3,333 IU, will be administered daily.
15834274|NCT04170348|Drug|Bolus oral vitamin D3, 100,000 IU|Bolus oral vitamin D3, 100,000 IU, will be administered monthly.
15834275|NCT04170348|Drug|Placebo oral tablet|Participants randomized to receive once monthly oral bolus of vitamin D3, will receive placebo on all other days of the month.
15834276|NCT04170335|Procedure|Bariatric surgery|Patients selected and consented for elective bariatric surgery will undergo standard of care preoperative mammogram, as well as inflammatory markers measurements and breast cancer risk score calculation. Post bariatric surgery the patients will have follow up mammogram, inflammatory markers, and breast cancer risk score calculation
15834277|NCT04170322|Device|thin pvc gastric tube|a thin pvc gastric tube of 40 Fr for sleeve is used to guide the surgeon
15834278|NCT04170322|Device|thick silicone gastric tube|a thick silicone gastric tube 40 Fr for sleeve is used to guide the surgeon
15834279|NCT04170309|Drug|Ceftobiprole medocaril|Participants in whom treatment with Ceftobiprole medocaril has been completed
15834280|NCT04170296|Drug|EN3835|Collagenase Clostridium Histolyticum (CCH)
15834281|NCT04170283|Drug|Zanubrutinib|Participants will receive zanubrutinib at a dose of 160 mg twice daily (for a total daily dose of 320 mg), or the last dose level received in the BeiGene parent study.
15834282|NCT04170283|Drug|Tislelizumab|Patients in Australia who participated in a parent study that involved combination therapy of zanubrutinib and tislelizumab will receive tislelizumab at a dose of 200mg every 3 weeks..
15834283|NCT04170270|Drug|Omeprazole|"Pre endoscopically: all patients will receive 80 mg omeprazole by 30 minute IV infusion.
~After performing upper endoscopy (with initial hemostasis), the patient will be randomly allocated into two groups; group A patients will receive oral omeprazole, while group B patients are intended to receive IV omeprazole.
~For patients of group A, omeprazole 40 mg will be administrated orally every 12 hours for 72 hours. Regarding group B, continuous infusion of omeprazole will be administrated at a rate of 8 mg/hour, for 72 hours."
15834284|NCT04170257|Diagnostic Test|Endoscopic examination using white light, NBI and iodine staining|Participants' esophagus will be examined by three commonly used diagnostic techniques in the order of : 1. White light endoscopy (WLE); 2. Narrow Band Imaging (NBI) and 3. Iodine Staining Endoscopy (ISE) with 1.2% Lugol's iodine solution. The required observation time is no less than 1 minute for WLE and 2 minutes for NBI and ISE. Endoscopic images of each participant are routinely captured at every 5 centimeters in the esophagus, and information is recorded in detail for each focal lesion. Biopsies are taken from all visually abnormal areas found by any one of the three techniques, histopathologic diagnoses are rendered by two pathologists according to standard criteria and discrepancies are adjudicated by consultation. The recorded endoscopic images for each biopsied lesion are read by two trained researchers and the visualized feature of lesions are decomposed into several indicators (e.g. size, shape, color, and border of lesions) .
15834287|NCT04170179|Procedure|Systemic chemotherapy|administration of oxaliplatin , fluorouracil, and leucovorin via the peripherally inserted central catheter every 3 weeks
15834288|NCT04170179|Drug|Lenvatinib|12 mg (or 8 mg) once daily (QD) oral dosing.
15834289|NCT04170179|Drug|Toripalimab|240mg intravenously every 3 weeks
15834290|NCT04170166|Procedure|Anterolateral subacromial steroid injection|Applying to the anterolateral approach arm, this group will receive their subacromial steroid injection via an anterolateral approach
15834291|NCT04170166|Procedure|Posterior subacromial steroid injection|Applying to the posterior approach arm, this group will receive their subacromial steroid injection via an posterior approach
15834292|NCT04170153|Drug|M1774|M1774 will be administered orally throughout the study.
15834293|NCT04170153|Drug|Niraparib|Niraparib will be administered orally throughout the study.
15834294|NCT04170140|Other|No intervention|Questionnaire
15834295|NCT04170127|Procedure|Irradiation of implants with 635nm laser|Irradiation of implants with 635nm laser
15834296|NCT04170114|Other|Comprehensive Respiratory Physiotherapy|"All patients will receive comprehensive respiratory physiotherapy training by the physiotherapist. All patients will undergo comprehensive respiratory physiotherapy techniques twice daily for 8 weeks.
~Comprehensive respiratory physiotherapy programme will include diaphragmatic breathing exercise, thoracic expansion exercises, incentive spirometer exercise (Triflo), oscillatory PEP (Flutter), postural drainage, coughing techniques and teaching respiratory control."
15834297|NCT04170101|Procedure|deep NMB|0,6 mg/kg LBW Rocuronium is used to facilitate intubation, and followed by an infusion of 1 mg/kg LBW/h , further adapted to keep PTC < 3
15834298|NCT04170101|Procedure|moderate NMB|0,6 mg/kg LBW rocuronium is used to facilitate intubation, not followed by an infusion or extra bolus.
15834299|NCT04170088|Drug|Tranexamic Acid|Tranexamic acid intradermal injections were used for treatment of melasma
15834300|NCT04170088|Drug|0.9% Normal Saline|Normal saline used for comparision of efficacy of tranexamic acid
15834301|NCT04170075|Behavioral|Whole Body Vibration|Undergo WBV
15834302|NCT04170062|Device|Nasal Delivery of High-Flow Air and Oxygen Therapy|They will receive high-flow air and oxygen via a dual lumen nasal cannula at rest. Participants will be administered the high-flow air and then titrated with oxygen from 0 L/min until they reach and maintain a SpO2 level of 95% for 30 seconds. They will then remain on this setting for 3 additional minutes with continuous monitoring of SpO2 levels.
15834303|NCT04170062|Device|Nasal Delivery of Oxygen Therapy|They will receive oxygen via a dual lumen nasal cannula at rest. Participants will be titrated with oxygen from 0 L/min until they reach and maintain a SpO2 level of 95% for 30 seconds. They will then remain on this setting for 3 additional minutes with continuous monitoring of SpO2 levels.
15834304|NCT04170049|Behavioral|Sensory Stimulative Activitiy ( proprioceptive intervention, music intervention )|Music intervention: Listening to soft music was found to be an effective method of relaxation, as indicated by a shift of the autonomic balance toward parasympathetic activity. Participants listen to preferred soft music for 30 minutes before sleeping. Proprioceptive intervention: The proprioceptive intervention can activate the parasympathetic nervous system through pathways of the central nervous system, providing calming effects that significantly reduce anxiety, hyperactivity and agitation in various populations.Participants do 10-minute joint compression exercise three times per day by themselves.
15834305|NCT04170036|Dietary Supplement|protein supplement|Protein supplement usage for at least three preceding months in varied amounts
15834306|NCT04170023|Drug|ALXN2050|Oral FD inhibitor
15834307|NCT04169997|Drug|IMP4927|IMP4297 tablet.The starting dose from 100mg QD
15834308|NCT04169997|Drug|Placebos|Placebos tablet.The starting dose from 100mg QD
15834309|NCT04169984|Other|Myofunctional Therapy|Isometric, isokinetic and isotonic exercises for the upper airway muscles.
15834310|NCT04169984|Other|Placebo|Exercises that do not alter the function or morphology of the upper airway.
15834311|NCT04169971|Other|Music|Played through headphones during the operation under spinal anaesthesia
15834312|NCT04169958|Other|safe mood|A tablet application that developed for this study. In addition, sensors are used to examine the possibility of using the system to assess the risk of suicide
15834313|NCT04169945|Other|Ultrasonic instrumentation|Full mouth root surface debridement
15834314|NCT04169945|Other|Air polishing with erythritol powder|Air flow PLUS
15834315|NCT04169932|Biological|CD20 CAR-T|The maximum dose was determined according to the dose escalation test. Based on the number of CART cells per kg body weight which was proved to be safe and effective, all the subjects were treated with one single dose of CD20 CART cells per treatment course. The dose escalation test was designed to evaluate the four dose levels of CD20-CART (1 × 10 ^ 6 cells/kg,2 × 10 ^ 6 cells/kg,4 × 10 ^ 6 cells/kg,8 × 10 ^ 6 cells/kg).
15834316|NCT04169919|Drug|Povidone-Iodine|Povidone-Iodine 5% eye wash
15834317|NCT04169919|Drug|Normal Saline Flush|Normal Saline eye wash
15834318|NCT04169906|Drug|Placebo|Participants will receive placebo once daily for 7 consective days
15834319|NCT04169906|Drug|TS-142, 10 mg|Participants will receive 10 mg of TS-142 once daily for 7 consective days
15834320|NCT04169906|Drug|TS-142, 20 mg|Participants will receive 20 mg of TS-142 once daily for 7 consective days
15834321|NCT04169906|Drug|TS-142, 30 mg|Participants will receive 30 mg of TS-142 once daily for 7 consective days
15834322|NCT04169893|Drug|Placebo (fasting)|Participants will receive placebo once in fasting condition
15834323|NCT04169893|Drug|Placebo (feeding)|Participants will receive placebo once after meal condition
15834324|NCT04169893|Drug|1 mg of TS-142|Participants will receive 1 mg of TS-142 once in fasting condition
15834325|NCT04169893|Drug|3 mg of TS-142|Participants will receive 3 mg of TS-142 once in fasting condition
15834326|NCT04169893|Drug|10 mg of TS-142 (fasting)|Participants will receive 10 mg of TS-142 once in fasting condition
15834327|NCT04169893|Drug|10 mg of TS-142 (feeding)|Participants will receive 10 mg of TS-142 once after meal condition
15834328|NCT04169893|Drug|30 mg of TS-142|Participants will receive 30 mg of TS-142 once in fasting condition
15834329|NCT04169880|Device|HILT|HILT will be performed with BTL 6000 High Intensity Laser (London, UK) which is a therapeutic non-invasive neodymium: yttrium aluminum garnet laser that has a pulsating waveform and 1064 nm wavelength, 12 Watt maximum power and has the ability to penetrate 12 cm.
15834330|NCT04169880|Combination Product|HILT & EXERCISE|HILT&Exercise group will receive exercise therapy right after they receive HILT. Both groups will receive treatment for 3 days a week, on alternate days and totally 10 sessions. Patients will be asked not to use analgesic medication throughout the treatment period.
15834331|NCT04169867|Biological|Collection of stool samples|Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).
15834332|NCT04169854|Drug|Lidocaine 5% patch|The Lidocaine 5% Patch will be applied to cover the marked incision site and head-holders sites for 3 consecutive preoperative days between 6:00 P.M. to 6:00 A.M.. Research assistants will be responsible for instructing patients to cover the patches correctly.
15834333|NCT04169854|Drug|Placebo patch|The Placebo Patch will be applied to cover the marked incision site and head-holders sites for 3 consecutive preoperative days between 6:00 P.M. to 6:00 A.M.. Research assistants will be responsible for instructing patients to cover the patches correctly.
15834334|NCT04169841|Drug|olaparib, durvalumab, tremelimumab|"STEP 1:
~Olaparib 300 mg BID during 8 weeks. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water. The tablets should be swallowed whole and not chewed, crushed, dissolved or divided. Olaparib tablets can be taken with or without food
~STEP 2:
~Olaparib 300 mg during 4 months as per same requirement as below. Durvalumab 1500 mg plus tremelimumab 75 mg via IV infusion Q4W, starting on Week 0, for up to a maximum of 4 doses followed by durvalumab monotherapy 1500 mg via IV infusion Q4W, starting 4 weeks after the last infusion of the combination and in response or stable after prior molecular target therapy by olaparib based on molecular sequencing."
15834335|NCT04169828|Drug|Methotrexate|Children in both the intervention and control group will receive Methotrexate dose as prescribed by the rheumatologist
15834336|NCT04169828|Drug|Ondansetron|"Children in the intervention group will be prescribed premedication with oral ondansetron.
~Children in the control group will be prescribed ondansetron ONLY if the child reports nausea/vomiting during regular treatment care with Methotrexate"
15834337|NCT04169815|Diagnostic Test|Access Immunodiagnostic Products|Access Natriuretic Peptide Assay
15834338|NCT04169802|Diagnostic Test|Retinal Health Monitoring System Visual Acuity Module|Assessment of corrected near visual acuity
15834339|NCT04169802|Diagnostic Test|Sloan letter, logarithmic near visual acuity chart (Reference Chart)|Assessment of corrected near visual acuity
15834340|NCT04169789|Dietary Supplement|Lactobacillus reuteri ATCC PTA 6475 (L. reuteri 6475)|L.reuteri high or low dose with cholecalciferol compared to cholecalciferol only.
15834341|NCT04169776|Device|Transcutaneous Auricular Vagus Nerve (taVNS) stimulation|Participants in this study will perform home transcutaneous auricular vagus nerve stimulation (taVNS) for 5 minutes a day for a 6-month period. The device that will be used is the commercially available Roscoe Medical TENS 7000 vagus nerve stimulator. The device will be attached to the Cymba Concha of the ear via an electrode ear clip. The intensity of the stimulation will be slowly increased and adjusted to individual tolerability for each treatment. TaVNS will be performed for 5 minutes daily for a period of 6 months.
15834342|NCT04169763|Drug|Cisplatin|Given IV
15834343|NCT04169763|Radiation|External Beam Radiation Therapy|Undergo EBRT
15834344|NCT04169763|Drug|Nelfinavir|Given PO
15834345|NCT04169750|Behavioral|Exergames|"The training protocol will be delivered by the Nintendo ® Wii balance board and consists of repetitions of several games selected from the Wii Fit Plus package (http:// www.wiifit.com/training/balance-games.html). Each game starts at basic level, and when a certain score is reached, patients is automatically transferred to a more advanced level. Patients will be encouraged to play the next game if they have a level progress; otherwise, 10 minutes will be allocated for each game. During the first 4 weeks of training, patients will be allowed to play only Zazen (sitting position), Table Tilt and Ski Slalom; thereafter they will add the remaining games Penguin Slide, Tightrope Walk, Balance Bubble and Soccer Heading."
15834346|NCT04169750|Behavioral|Adaptive COGNI-TRAcK|"The training protocol will be delivered by a dedicated app for mobile devices (mobile phone or tablet). The app implements three different types of exercises (each one executed for about 10 min a session), consisting in a visuo-spatial working memory task, an operation N-back task and a dual N-back task.
~The adaptive training is structured so that the exercises difficulty level will increase by one step every time the user will perform a correct exercise. On the other hand, the difficulty level will decrease by one step if the exercise is incorrect for three times in a row."
15834347|NCT04169750|Behavioral|Sham COGNI-TRAcK|The training protocol will be delivered by a dedicated app for mobile devices (mobile phone or tablet) as previously described for adaptive COGNI-TRAcK. However, the non-adaptive training (placebo-analogue intervention) consists in an algorithm implementing two low difficulty levels alternating every day regardless of the user's performance.
15834348|NCT04169737|Drug|Acalabrutinib|Given PO
15834349|NCT04169737|Biological|Obinutuzumab|Given IV
15834350|NCT04169737|Drug|Venetoclax|Given PO
15834351|NCT04169724|Behavioral|Calm Meditation|10 minutes per day of meditation via the Calm app.
15834352|NCT04169711|Drug|ARO-HIF2|Multiple doses of ARO-HIF2 by intravenous infusion
15834353|NCT04169698|Drug|Denosumab 60 mg/ml [Prolia]|full length human monoclonal antibody against the receptor activator of nuclear factor kappa-B ligand
15834354|NCT04169698|Drug|Alendronate 70Mg Tab|Bisphosphonates
15834355|NCT04169685|Procedure|bronchoscopy|during flexible bronchoscopy
15834356|NCT04169672|Drug|Surufatinib|Surufatinib is a tablet in the form of 50mg, oral, once a day.
15834357|NCT04169672|Drug|Toripalimab|Toripalimab is an injection in the form of 240mg, intravenous, once three weeks.
15834358|NCT04169659|Device|Kyphoplasty with insertion of Sctructured Titanium Microspheres|Under fluoroscophy, we introduce a transpeduncolar trocar inside the vertebral body where is performed a kyphoplasty with insertion of baloons. When the dome is cretated we introduce structured titanium microspheres until the dome is full of material.
15834359|NCT04169659|Device|Kyphoplasty with Polimethylmetacrilate (convetional surgery)|Under fluoroscophy, we introduce a transpeduncolar trocar inside the vertebral body where is performed a kyphoplasty with insertion of baloons. When the dome is cretated we introduce Polimethylmetacrilate until the dome is full of material.
15834383|NCT04169438|Other|FS2 Emulsion Moisturizer + Petrolatum|Topical FS2 white (bone) color, oil/water emulsion moisturizer.
15834384|NCT04169425|Procedure|elective diverting ileostomy|
15834360|NCT04169646|Other|Multi-component intervention|Participants' workstation ergonomics will be assessed using an observation-based ergonomics assessment checklist for office-workers adapted to Swiss guidelines. Based on the initial assessment, best practice ergonomics will be applied individually using existing infrastructure. Participants will attend health promotion information group workshops for approximately one hour per week for 12 weeks. it. Participants will receive an individual progressive exercise programme aimed at conditioning the muscles of the neck and shoulder girdle. The exercises will be performed in groups (maximum of ten per group) at the workplace in a dedicated room, for approximately one hour (3x20 minutes) per week; once per week supervised by a physiotherapist, a human movement scientist, or a health scientist, and twice per week individually. Workshop session attendance will be recorded as an indication of adherence to health promotion. Adherence to neck exercises will be recorded with the Physitrack® app.
15834361|NCT04169646|Other|Control|No intervention takes place during the control phase.
15834362|NCT04169633|Diagnostic Test|Cognitive Function Evaluation|Evaluation of cognitive function and evaluation of daily cognition
15834363|NCT04169620|Other|aquatic Ai Chi|"The sessions took place in a pool measuring 20 m x 6 m, at a depth of 110 cm. The water temperature was 30oC (with variations of less than 0.5o) and the room temperature was 27.5oC (with variations of less than 1o). The proportions of the pool were ideally suited for collective treatment.
~The sessions were designed with a gradual increase in difficulty. Initially, a recreational warm-up activity was performed, followed by 30 minutes dedicated to practicing the Ai Chi Program. At the end of the session there was a calming down activity. The exercises were performed in a specific order, until completion of the 19 possible movements."
15834364|NCT04169620|Other|control|These sessions consisted of group sessions of supervised training lasting 45 minutes each. These comprised a 10-minute warm-up that included exercises for gait, trunk mobility and exercises involving the upper and lower limbs. The central part of the sessions consisted of 30-40 minutes of strength training and aerobic exercises, both individual and in groups. Each session was performed with a specific intensity goal, in order to end with a cooling down period, comprising 20 minutes of functional exercises based on activities of daily living, balance exercises, facial muscle exercises, proprioceptive exercises, muscle relaxation and stretching.
15834365|NCT04169607|Procedure|Dynamic compliance guided individualized positive end-expiratory pressure titration strategy|"Basic ventilation: Volume-controlled ventilation (VCV) mode with positive end-expiratory pressure (PEEP) of 8cm H2O after induction of anesthesia，
~Recruitment maneuver (RM): Pressure-controlled ventilation (PCV) mode increasing PEEP from 10 to 25cmH2O in step of 5cmH2O per 30s.
~PEEP-titration maneuver: ventilation parameters reset as basic ventilation with PEEP still 25cmH2O.Decrease PEEP to 5cmH2O in step of 2cmH2O per 10 respiratory cycles to confirm the highest dynamic lung compliance (Cdy).
~After titration: A new RM will be performed and the final PEEP will be the one related to highest Cdy plus 2cm H2O.
~Randomized after the second RM. Individualized PEEP arm: maintain individualized PEEP; PEEP8 arm: maintain a fixed PEEP of 8cm H2O.
~VCV with other ventilation parameters the same as basic ventilation until extubation .
~After discharged from postoperative anesthesia care unit (60 to 90 minutes after extubation): chest CT ."
15834367|NCT04169568|Procedure|Manuel cuff blood pressure|Blood pressure will be obtained using a sphygmomanometer. Only Registered Nurses will apply BP cuff after careful inspection of the upper extremity for bruising, swelling or tenderness.
15834368|NCT04169555|Procedure|Ultrasound|"The emergency physician will perform a point of care ultrasound. If signs of expansions of the pelvicalyceal cavities are found, an early CT scan will follow"
15834369|NCT04169555|Other|Standard care|Standard clinical care of patients. In regards of the clinical evolution and of biological results, a CT scan could be performed by the physician.
15834370|NCT04169542|Other|Questionnaire Administration|Complete questionnaires
15834371|NCT04169529|Device|Reveal LINQ|Insertion of Reveal LINQ device to characterize collected data from patients with COPD.
15834372|NCT04169516|Diagnostic Test|index of microcirculatory resistance|Physiological parameters of the culprit artery after PCI were determined with the restoration of Thrombolysis in Myocardial Infarction (TIMI) 3 flow. Aortic pressure (Pa), distal intracoronary pressure (Pd), fractional flow reserve (FFR), coronary flow reserve (CFR) and index of microcirculatory resistance (IMR) were measured using a 0.014 coronary temperature and pressure-sensing guidewire (PressureWireCertus, ST. Jude Medical, MN, USA).
15834373|NCT04169503|Drug|Immune Checkpoint Modulator|identification of cases of immune-related adverse events due to immune checkpoint inhibitors. Among these cases, identification and description of those with immune checkpoint inhibitor rechallenge.
15834374|NCT04169490|Other|Placebo Cream Base Emulsion Moisturizer|Topical placebo white, oil/water emulsion moisturizer applied b.d. for 120 days
15834375|NCT04169490|Other|FS2 Emulsion Moisturizer|Topical FS2 white, oil/water emulsion moisturizer applied b.d. for 120 days
15834376|NCT04169490|Other|Active Comparator Onion Skin Extract Gel (Mederma)|Topical onion skin extract gel (Mederma) applied b.d. for 120 days
15834377|NCT04169490|Other|Active Comparator Silicone Gel (Kelo-Cote)|Topical silicone gel (Kelo-Cote) applied b.d. for 120 days
15834378|NCT04169490|Other|Active Comparator Silicone Gel (Kelo-Cote) + FS2 Emulsion Moisturizer|Topical silicone gel (Kelo-Cote) + Topical FS2 white, oil/water emulsion moisturizer applied b.d. for 120 days
15834379|NCT04169477|Device|CEFAR Primo Pro (TENS device)|"During the first month: Patients will have to test 3 sessions of TENS 1 hour/day. Depending on their arm assigned by randomization, patients will begin with c-TENS or m-TENS.
~[Cross-over] During the second month: Patients will test the other type they do not have used yet according to the following scheme: 3 sessions of 1 hour, each day.
~In this way, all patients will test successively the 2 different modes. After the end of the second month and up to the end of their participation (6 months after randomization) patients will be free to use the mode of TENS they prefer."
15834380|NCT04169464|Drug|Sofosbuvir Oral Product|to investigate the drug effect on renal function and insulin resistance
15834381|NCT04169451|Drug|Letrozole|Women will be randomized to the group with ovarian stimulation with letrozole or the group without stimulation.
15834382|NCT04169438|Other|Vehicle Cream Base Emulsion Moisturizer + Petrolatum|Topical vehicle white (bone) color, oil/water emulsion moisturizer.
15834385|NCT04169412|Diagnostic Test|Blood Collection|Blood Gas Analysis using Stat Profile pHOx® Series (nova biomedical, Waltham, U.S.) and Enzym-linked Immunosorbent Assay (ELISA) using Bio-Rad (Bio-Rad Laboratories, California, U.S.)
15834386|NCT04169399|Drug|Toripalimab|240mg intravenously every 3 weeks
15834387|NCT04169399|Radiation|Stereotactic body radiotherapy|Radiotherapy dose was 36 ~ 54Gy, divided into 6 times of irradiation, and the radiation was performed within 2 weeks.
15834388|NCT04169386|Drug|AK102|AK102 single dose administered subcutaneously
15834389|NCT04169386|Drug|Placebo|Placebo single dose administered subcutaneously
15834392|NCT04169360|Drug|ANS-6637|White, oblong 300 mg tablet
15834393|NCT04169360|Drug|Placebo oral tablet|White, oblong 300 mg tablet
15834394|NCT04169347|Drug|Oxaliplatin|2 week cycles
15834395|NCT04169334|Behavioral|Prolonged planned program for the stay at the obstetric department|A five day planned and designed program delivered to the family while at the obstetric department.
15834396|NCT04169321|Drug|Single Arm|[68Ga]-NOTA-hGZP is a PET imaging agent.
15834397|NCT04169308|Drug|Restylane-L® Filler injection|Restylane-L® Filler injection into the soft tissue of the nose
15834398|NCT04169295|Other|Gynecologists' feedback on ART-Birth rates|At the time of their fresh embryo transfer couples will receive a document with the following feedback: a photo of their transferred embryo, the number of cryopreserved embryos, the quality rating of the transferred embryo's and couple's personalized IVF-prognosis (i.e. their chance on a live birth from the current IVF-cycle, including the transfer of fresh and if available cryopreserved embryos), calculated by entering eight background characteristics and five IVF-laboratory results into a prognostic model.
15834399|NCT04169295|Other|Control group|At the time of their fresh embryo transfer couples will receive a document with the following feedback: a photo of their transferred embryo and the number of cryopreserved embryos
15834400|NCT04169282|Device|nPEP (non-invasive positive expiratory pressure) mask|Positive end expiratory pressure (PEEP) mask
15834401|NCT04169269|Drug|Enoxaparin 40 milligram/0.4 milliliter Injectable Syringe 0.4 milliliters|anticoagulant, subcutaneous injection
15834402|NCT04169269|Drug|Rivaroxaban 10 milligram Oral Tablet|anticoagulant, oral
15834403|NCT04169256|Drug|HYR-PB21|HYR-PB21 for injection 100mg, 200mg,or 400mg by single subcutaneous injection on the abdomen
15834404|NCT04169256|Drug|Liposomal bupivacaine|Liposome Bupivacaine Suspension for injection 200mg by single subcutaneous injection on the abdomen
15834405|NCT04169256|Other|Normal Saline|Normal Saline 30ml, or 40mL by single subcutaneous injection on the abdomen
15834406|NCT04169243|Behavioral|New Nordic Diet|The New Nordic Diet conforms with the Nordic Nutrition Recommendations and incorporates environmental sustainability and planetary health. It includes rapeseed oil, whole grain bread, wild fish, seafood and game, potatoes, root vegetables, cabbages, Nordic fruits and berries. A two-week menu including all daily meals has been created to ensure dietary goals of the New Nordic Diet intervention: fish and shellfish intake ≥ 3 times/w (fatty fish at least once per week), ≥ 500 g fruit, berries, vegetables and legumes daily (legumes as main protein source at least twice per week), whole-grain cereal products, rapeseed oil for cooking/dressing and three table spoons of nuts and seeds per day.
15834407|NCT04169243|Other|Control|The control women receive diet advice according to usual care, which may be a short meeting with the regular midwife or a short meeting with a dietician. From the study, they will receive a gift certificate that can be used in grocery stores.
15834408|NCT04169230|Drug|Citalopram|Single dose administration of citalopram (20mg)
15834409|NCT04169230|Drug|Placebo oral tablet|Single dose administration lactose placebo tablet
15834410|NCT04169217|Behavioral|Prehabilitation|A combination of on off workshop and mentored prehabilitation
15834411|NCT04169204|Diagnostic Test|Measurement of microcirculation|As a simple clinical test, every patient will receive the assessment capillary refill time and mottling-score. Additionally, repetitive measurements of lactate will be done. The SDF-camera (MicroVision Medical®, Amsterdam, Netherlands) will measure sublingual microcirculation at different time points (Admission and 24h).
15834412|NCT04169191|Drug|Sildenafil Citrate|Cohort 1 of 3-6 neonates: 1st dose of 2mg/kg/dose, 2nd dose of 2.5 mg/kg/dose, and subsequent doses of 2.5mg/kg/dose q12h (= 5 mg/kg/day from dose #2) Cohort 2 of 3-6 neonates: 1st dose of 2mg/kg/dose, 2nd dose of 2.5 mg/kg/dose, 3rd dose of 3mg/kg/dose, and subsequent doses of 3mg/kg/dose q12h (= 6 mg/kg/day from dose #3) dose expansion phase in up to 5-15 asphyxiated neonates
15834413|NCT04169178|Drug|HLX55|A humanized IgG2 monoclonal antibody targeting tyrosine-protein kinase MET (c-MET)
15834414|NCT04169152|Procedure|Cap-assisted endoscopic sclerotherapy|Cap-assisted endoscopic sclerotherapy (CAES) is an innovation technique for having advantages in accurately controlling the injection angle, direction, depth under direct vision of flexible endoscope.
15834415|NCT04169139|Device|MIST (minimally invasive surgical therapy)|REPaiR Periodontal Therapy
15834416|NCT04169126|Drug|F-18 PMPBB3|The study will enroll 200 patients with prodromal AD and AD dementia and 100 normal controls, men and women aged 55-80 years across core clinical criteria of prodromal AD and mild AD dementia based on IWG-2 criteria.
15834417|NCT04169113|Other|Group 1 - Opiate Tablets post Hip Arthroscopy|Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
15834418|NCT04169113|Other|Group 2 - Opiate Tablets post Hip Arthroscopy|Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
15834419|NCT04169100|Drug|Prednisone|We propose to test whether QT prolongation is reversible with moderate doses of prednisone in patients with QT interval greater than 500 msec.
15834420|NCT04169087|Other|QoR-15|The QoR-15 is the questionnaire to provide an evaluation of the postoperative quality of recovery. Patients undergoing surgery and general anesthesia are asked by the investigators to complete the QoR-15 questionnaire before and 24h after the surgery.
15834421|NCT04169074|Drug|Abemaciclib|Treatment will consist of a single neoadjuvant cycle of 10-21 days (+7 days). Abemaciclib will be administered from days 1-21 in both arms. Abemaciclib may be continued for an additional 7 days, or up to 28 days, for delays in planned surgery.
15834422|NCT04169061|Drug|Acthar|Acthar gel for subcutaneous injection
15834423|NCT04169048|Behavioral|Group training for mothers with Borderline Personality Disorder|The group programme is designed to teach mothers with BPD parenting skills and to reduce dysfunctional parenting attitudes and strategies. The components are: childrens basics needs, mindfulness, stress and stress reduction, dealing with conflicts, dealing with emotions, dysfunctional attitudes, physical contact, parenting rules, self care.
15834424|NCT04169035|Device|The BD Odon DeviceTM is a new device for AVB that has been designed by a team of midwives, doctors and engineers.|The BD Odon DeviceTM works by placing a cuff of air attached to a plastic sleeve, around the baby's head. The doctor then gently pulls on this sleeve and air cuff to assist the birth of the baby.
15834425|NCT04169035|Procedure|forceps or ventouse|"The woman is unable to have an Odon assisted birth as no Odon trained practitioner is available to assist the birth.
~Forceps is a metal instrument with two handles used to encircle a baby's head and assist in birth.
~Ventouse is a device used to help a baby be born by putting it over the baby's head and using suction (= removing air) to pull the baby out of the mother's body."
15834426|NCT04169022|Other|Sample collection|Sample collection blood and/or bone marrow
15834427|NCT04169009|Biological|Zostavax|Intradermal injection of Zostavax
15834428|NCT04169009|Biological|Shingrix|Given to subjects in Arm 4 who've never had a herpes zoster vaccine
15834429|NCT04168996|Behavioral|Individualized discharge planning|Discharge planning is designed to ensure healthcare continuity, avoid preventable poor outcomes among at-risk populations, and promote the safe and timely transfer of patient care. The individualized discharge planning is characterized to take into account the preferences, interests and clinical profile of each patient.
15834430|NCT04168983|Other|sophrology|Sophrology session provided by a nurse sophrologist in addition to the usual care during BMAB
15834431|NCT04168970|Procedure|PSGB|Percutaneous stellate ganglion block: injection of 10 mL of local anaesthetic (lidocaine 2%) at the C6 level using the anatomic technique or the echo-guided technique The anaesthetic that will be used for PSGB is lidocaine.
15834432|NCT04168957|Drug|Oraxol|"Oraxol (Oral paclitaxel + oral HM30181AK-US)
~Paclitaxel: supplied as capsules HM30181 methanesulfonate monohydrate: supplied as HM30181AK-US tablets"
15834433|NCT04168944|Drug|Lenvatinib|Patients in the lenvatinib group are given lenvatinib within 1-2 months after operation
15834434|NCT04168944|Drug|Placebo|Sugar pill manufactured to mimic Lenvatinib 10mg tablet
15834435|NCT04168944|Drug|Immunosuppressive regimen|Immunosuppressive regimen consisting of calcineurin inhibitor, mycophenolate mofetil, sirolimus or ivermus
15834436|NCT04168931|Drug|Trastuzumab|The first-line standard treatment for gastric cancer is based on fluoropyrimidine and platinum-containing chemotherapy (FOLFOX). When the tumor expresses HER2 3+ on IHC or 2+ and is confirmed by FISH, trastuzumab at the standard dose of 8 mg / kg in D1 of the first cycle is added, followed by 6 mg / kg every 2 weeks for the remaining cycles until disease progression, unacceptable toxicity. (3) We will use the same doses of trastuzumab, but HER2 positivity is determined by immunocytochemical expression and FISH in CTCs for patients with negative expression in tissue biopsy.
15834437|NCT04168918|Behavioral|Group psychological Intervention|There will be 6 sessions covering 6 topics (Understanding mental disorders, Self-stigma, Social support, Substance use and mental illness, Self-help strategies, Available mental health services). Each session will begin with welcoming, reviewing what was done in the last session and home assignments (where applicable), question-guided discussion, lecture, group sharing and home assignment
15834438|NCT04168905|Device|AOTI Inc. TWO2 topical oxygen therapy equipment|Patients will apply themselves oxygen therapy at home for 5 days a week, 90 minutes a day, rest for 2 days, and follow-up once a week. A total of 12 weeks of treatment, or recieving treatment till wound healed.
15834439|NCT04168892|Drug|150 IU of HMG in patients with age ≤ 35 years|The use of a different starting dose, based on the female age, derives from the necessity to control the effect of a variable starting dose on the primary outcome.
15834440|NCT04168892|Drug|225 IU of HMG in patients with age > 35 years|The use of a different starting dose, based on the female age, derives from the necessity to control the effect of a variable starting dose on the primary outcome.
15834441|NCT04168879|Drug|Bupivacaine 0.5% Preservative-Free Injectable Solution|1.5 ml of Bupivacaine 0.5% Preservative-Free Injectable Solution used transnasally to block the sphenopalatine ganglion
15834442|NCT04168879|Drug|normal saline|1.5 ml of normal saline is delivered transnasally to the sphenopalatine ganglion
15834443|NCT04168866|Procedure|Operative management|Surgery for computer tomography (CT)-proven complicated appendicitis with phlegmon or abscess.
15834444|NCT04168866|Other|Drainage or antibiotics|If an abscess is present and amenable to percutaneous drainage this will be performed. If there is no abscess or it is not amenable to drainage antibiotics alone will be provided.
15834445|NCT04168853|Diagnostic Test|vascular reactivity of internal thoracic arteries|"Internal thoracic arteries analysis Myography Superoxide detection and confocal microscopy Immunochemistry Quantitative real time transcription-polymerase chain reaction (RT-PCR) analysis
~Blood sampling and biochemical analysis"
15834446|NCT04168840|Diagnostic Test|Compare clinical test with ultrasound parameters|Compare various clinical test with four ultrasound parameters to predict difficult intubation.
15834447|NCT04168827|Behavioral|Questionnaire|Questionnaire completed by the parents of severe traumatized child, between 3 to 6 months after the leaving of the child out of intensive care unit
15834448|NCT04168814|Other|Observational test|Nutritional risk (NutriScore), based on weight, weight loss, tumor location, and treatment, Nutritional status (VGS, Global Subjective Assessment Valoración Global Subjetiva, in Spanish), ECOG performance status; nutritional therapy (oral nutritional supplements, enteral nutrition, parenteral nutrition, dietary advice); type of treatment: chemo, type of chemo, adjuvant, neoadjuvant, palliative, curative endocrine therapy, targeted therapy +-immunotherapy vs QQT/RT therapy; cancer site. Covid-19 diagnosis.
15834449|NCT04168801|Dietary Supplement|early oral refeeding|Once the patient had a score of 1-3 of the analogue numerical scale (ENA), he was interrogated about symptoms such as nausea or vomiting, receives diet indicated between 16 and 24 hours after admission.
15834450|NCT04168788|Other|Blood test for genetic analysis|Drawing blood to realize a genetic analysis for susceptibility to hepatic VOD.
15834451|NCT04168775|Other|Home PIFR monitoring with InCheck Dial|The In-Check G16 DIAL® (Alliance Tech Medical, Granbury TX) is a simple hand-held device that measures PIFR via a brief inspiratory maneuver.
15834452|NCT04168762|Other|Transcranial Ultrasound Magnetic Stimulation|Transcranial Ultrasound Magnetic Stimulation is a paradigm that allows for concurrent and concentric ultrasound stimulation with transcranial magnetic stimulation (TMS).
15834453|NCT04168749|Combination Product|Numeta G13|10 days
15834454|NCT04168736|Other|Feasibility and Acceptability of Genetic Counseling Materials|"To determine the feasibility and acceptability of a communication aid in sharing genetic test results with family members.
~To determine the utility of a communication aid in sharing information. To determine the impact of patient focused information sheets on patient knowledge of genetic testing."
15834455|NCT04168723|Drug|MD1003|Group A: Daily dose of 1200 mg of MD1003 from Day 1 to Day 8
15834456|NCT04168723|Drug|Moxifloxacin 400mg|Group B1: Moxifloxacin 400 mg on Day 1 Group B2: Moxifloxacin 400 mg on Day 9
15834457|NCT04168723|Drug|Placebo for MD1003|Group A: Placebo for MD1003 on Day -1 Group B1: Placebo for MD1003 on Day -1 Group B2: Placebo for MD1003 on Day -1
15834458|NCT04168723|Drug|Placebo for moxifloxacin|Group A: Placebo for moxifloxacin on Day 1 and Day 9 Group B1: Placebo for moxifloxacin on Day 9 Group B2: Placebo for moxifloxacin on Day 1
15834459|NCT04168710|Drug|ESP block with bupivacaine|Each participant randomized to the ESP block group will receive an ultrasound guided single shot injection of 20cc of 0.25% bupivacaine in the plane between the transverse process of the spine and the erector spinae muscle.
15834460|NCT04168710|Other|Saline control/sham injection|Each participant randomized to the ESP block group will receive an ultrasound guided single shot injection of 20cc of normal saline in the plane between the transverse process of the spine and the erector spinae muscle.
15834461|NCT04168697|Behavioral|Wim Hof method|8-week behavioral modification intervention instructing the participants in a combination of breathing exercises, cold exposure and meditation
15834462|NCT04168684|Behavioral|Attachment and Biobehavioral Catch-up (ABC)|Manualized intervention implemented in home with parent and child present focused on parental responsiveness
15834463|NCT04168684|Behavioral|Developmental Education for Families (DEF)|Manualized intervention implemented in home with parent and child present focused on parental enhancement of child learning
15834464|NCT04168671|Diagnostic Test|Continuous laryngoscopy during exercise test|Continuous laryngoscopy during exercise test
15834465|NCT04168658|Combination Product|Physical activity and education intervention|"At least six staff from each nursing home that assigned to the intervention group will be invited to attend two educational workshops. Participants in the intervention group will receive the following interventions.
~Face-to-face workshops: Five 1-hour educational workshops on physical activity will be delivered in months 1, 3, 5, 7 and 9 of the program held at each nursing home.
~Booklet: At the first educational workshop, each participant will be provided with a pictorial booklet.
~Exercise: The physical activity training consists of 50-60 min exercise sessions three times a week on non-consecutive days for 12 months.
~Others (newsletters, phone calls, and reminders): The intervention group will also receive newsletters containing myth dispelling information on osteoporosis and physical activity, motivational phone calls and a total of 52 SMS via mobile phones (reminders to attend workshop sessions and physical activity motivating messages) over 12 months."
15834466|NCT04168658|Behavioral|Education intervention|Participants in the control group will only receive educational materials (i.e. face-to-face workshops and booklet) and will be wait listed to receive no other interventions of this study until after the post-intervention.
15834467|NCT04168645|Behavioral|Cognitive Behavioral Therapy|Up to 4 sessions of CBT (depending on length of stay) will be provided. The first session lasts 1.5 hours and subsequent sessions are 1 hour.
15834468|NCT04168632|Other|OPTIMAT|The intervention was to serve a new school lunch menu plan as similar as possible to a baseline menu plan but 40% lower in greenhouse gas emissions, being nutritionally adequate and no more expensive.
15834469|NCT04168619|Drug|Discontinue methotrexate|According to the international guideline, patients with Roenigk grade 3a which indicate methotrexate-induced liver injury may continue methotrexate with a repeat biopsy in 6 months. In patients with Roenigk grades 3b or 4, indicate significant liver fibrosis/cirrhosis, methotrexate should be discontinued.
15834470|NCT04168619|Other|Medication depends on clinical judgement|Once discontinued methotrexate, based on subject's clinical condition and prescribe alternative treatment
15834471|NCT04168593|Procedure|Acupuncture|20 min of Acupuncture section follow by 10 min of cupping around the knee
15834472|NCT04168580|Other|V02 max test/stress test|Aerobic fitness will be determined by measuring maximal O2 consumption (VO2max) during a stationary bicycle exercise test.
15834473|NCT04168580|Other|MRI|Brown adipose tissue will be differentiated from white adipose tissue using fat fraction and T2* relaxation time maps generated from a commercially available modified 6-point Dixon (mDixon) water-fat separation method. MRI scans will be performed on a Philips 3T using axial, coronal, and sagittal slice orientations to provide anatomical reference scans in the neck and body area. Quantitative mDixon scans will be used for calculating proton density fat fraction (PDFF) maps.
15834474|NCT04168580|Other|Dual Energy X-Ray Absorptiometry (DEXA)|DEXA Scans will be performed to measure body fat and estimate muscle mass using a General Electric (GE) Lunar iDXA whole-body scanner.
15834475|NCT04168580|Other|Handgrip strength test|All participants will perform a hand grip test that will be conducted three times with 1 minute of rest between each repetition using the dominant hand of each participant. The greatest grip strength and the average of the three tests will be recorded.
15834476|NCT04168580|Other|Lower extremity performance battery|The Short Physical Performance Battery (SPPB) is a brief performance-based test that will be used to measure lower extremity performance. The SPPB consists of three tasks: five repeated timed chair stands, timed standing balance (with feet in parallel, semi-tandem, and tandem positions), and a 4-meter walk to determine usual gait speed.
15834477|NCT04168580|Other|Step Test|Each participant will be asked to complete a timed step test
15834478|NCT04168580|Other|Resting Metabolic Rate/Respiratory Quotient (RMR/RQ)|Indirect calorimetry will used at two times during the hyperinsulinemic-euglycemic clamp to measure the resting metabolic rate/respiratory quotient (RMR/RQ) and substrate utilization using a MAX II Metabolic cart (AEI Technologies, Pittsburgh, PA).
15834479|NCT04168580|Other|Hyperinsulinemic-euglycemic clamp|After an overnight 8-hour fast, an intravenous catheter will be placed in the vein for infusion of insulin and glucose. A second catheter will be placed in the vein of the contra-lateral arm for blood withdrawal.
15834480|NCT04168580|Other|Exercise Training Intervention|Older sedentary participants will undergo 8 weeks of exercise training. The exercise program will be supervised by a certified exercise physiologist and will take place at the AdventHealth Translational Research Institute (TRI) exercise training facility. Exercise compliance will be monitored for exercise training 4 days per week (32 total sessions). Aerobic training will be 30 minutes of brisk walking, jogging, cycle ergometry. Walking will be the primary mode of aerobic exercise given its widespread popularity and ease of administration across a broad segment of the older adult population. Walking will be at a moderate intensity and determined based on Heart Rate (50-70% of Maximal Heart Rate from most recent VO2max) and rating of perceived exertion using Borg's scale (ranges from 6 to 20).
15834481|NCT04168580|Other|Post-Intervention Testing|Following the exercise training intervention, participants in the OA group will participate in post-intervention testing.
15834482|NCT04168567|Diagnostic Test|Microbiome analysis|Samples from the vagina, endometrium and anus and analyzing microbiome with NGS technique.
15834483|NCT04168554|Device|Telemedicine|Patient is examined using telemedicine
15834484|NCT04168541|Other|Oral Nutrition Supplement|Product intake of oral nutrition supplement provided
15834485|NCT04168528|Drug|68GaNOTA-Anti-MMR-VHH2|Injection of the radiopharmaceutical and PET/CT imaging
15834486|NCT04168502|Drug|Glasdegib|After randomization patients in both arms will be randomized to maintenance with glasdegib vs clinical observation
15834487|NCT04168502|Drug|Gemtuzumab Ozogamicin|Both arms, before randomization, will receive induction and consolidation with Gemtuzumab ozogamicin, Daunorubicin and Cytarabine
15834488|NCT04168489|Device|active rTMS|(rTMS) is received preliminary approval because of its noninvasive and safe analgesic effect.
15834489|NCT04168489|Device|sham rTMS|The sham rTMS is inactive and similar to placebo effect.
15834490|NCT04168476|Other|Interscapular muscle release or scapular mobilization technique as described by Travell and Simons.|"Patient is sidelying with the testing side up. The auditor stands in front of the patient, reaches over the patient's shoulder to grasp the upper portion of the vertebral border of the scapula, and the other arm reaches under the patient's humerus to grasp the lower portion of the vertebral border of the scapula.
~The auditor then slowly moves the scapula into elevation/depression, internal/external rotation/abduction and adduction.
~To standardize the technique and be able to reproduce it in each participant, a set of 10 repetitions for each movement was performed in the same order."
15834491|NCT04168476|Other|Calcaneus abduction and adduction mobilization technique|Abduction and adduction mobilization of the calcaneus is carried out in the opposite side of the upper extremity measured.
15834492|NCT04168463|Device|Two Joy for All robots (one cat and one dog)|Intervention will include the opportunity to interact with the Joy for All robot animals.
15834493|NCT04168450|Other|WiSAT System, Passive Feedback|The WiSAT system is installed in the participant's wheelchair cushion and a smartphone application is installed on his/her cellphone. Participants are able to view the application as they please and they will receive no notifications from the app regarding their movement goals.
15834494|NCT04168450|Other|WiSAT System, Active Feedback|The WiSAT system is installed in the participant's wheelchair cushion and smartphone application is installed on his/her cellphone. Participants receive notifications from the app to help them meet their movement goals.
15834495|NCT04168437|Other|Health-Related Quality of Life Report|Two page report and interpretation guide based on SPADE cluster scores
15834496|NCT04168424|Other|no intervention|Completing the questionnaire for health-related resource use in the elderly population (FIMA) by the elderly people
15834497|NCT04168411|Procedure|Symptomatic Treatment|Conservative treatment methods of tuberosity fractures of the proximal fifth metatarsal
15834498|NCT04168398|Drug|Combination drug|Anticoagulation
15834499|NCT04168385|Drug|Maralixibat|"Maralixibat chloride oral solution orally twice daily (up to 1200* mcg/kg/day), and according to indication.
~*equivalent to 1140 mcg/kg/day maralixibat"
15834500|NCT04168372|Other|High fructose, fructose labeled meal|Liquid meal containing high fructose (16% of energy), labeled with 2-13C fructose
15834501|NCT04168372|Other|High fructose, pyruvate labeled meal|Liquid meal containing high fructose (16% of energy), labeled with 2-13C pyruvate
15834502|NCT04168372|Other|Low fructose, fructose labeled meal|Liquid meals containing low fructose (6% of energy), labeled with 2-13C fructose
15834503|NCT04168372|Other|Low fructose, pyruvate labeled meal|Liquid meal containing low fructose (6% of energy), labeled with 2-13C pyruvate
15834504|NCT04168359|Device|absorbable semi-barbed suture|Positioning the intrapulmonary nodules of patient in this group with a absorbable semi-barbed suture positioning device
15834505|NCT04168346|Drug|Ferric carboxymaltose|Ferric carboxymaltose iv infusion
15834506|NCT04168346|Drug|Placebos|NaCl 0.9% infusion
15834507|NCT04168333|Biological|T101 Group|"Single Dose (SD) Cohort:
~In each group, 3 of chronic hepatitis B patients will be subcutaneously injected with different dose level of T101 at 1.0E+9VP (Group1)/1.0E+10VP (Group2)/1.0E+11VP (Group 3) on D1.
~Multiple Dose (MD) Cohort:
~In each group, 9 of chronic hepatitis B patients will be subcutaneously injected with different dose level of T101 at 1.0E+10VP (Group1)/1.0E+11VP (Group2) on D1, D8, D15."
15834508|NCT04168333|Biological|Placebo Group|"Single Dose (SD) Cohort:
~3 of chronic hepatitis B patients will be subcutaneously injected with placebo on D1.
~Multiple Dose (MD) Cohort:
~6 of chronic hepatitis B patients will be subcutaneously injected with placebo on D1, D8, D15."
15834509|NCT04168320|Radiation|SBRT-PATHY (SBRT-based PArtial Tumor irradiation targeting HYpoxic segment)|Novel stereotactic high-dose partial irradiation of the hypoxic segment of bulky tumors.
15834510|NCT04168307|Device|Ankle trainer device|The ankle trainer provides passive stretch in dorsal flexion of the ankle as well as active plantar flexion.
15834511|NCT04168307|Other|Conventional physiotherapy|The patients were instructed in stretching exercises using a non-elastic band
15834512|NCT04168294|Drug|Propofol|patients in sedation group will be intravenous injected propofol in bolus
15834513|NCT04168294|Device|endoscopy|endoscopy system
15834514|NCT04168281|Diagnostic Test|Magnetic resonance imaging (MRI)|instead of PCI patients will be followed-up with MRI
15834515|NCT04168255|Procedure|Double tamponade|Double tamponade procedure in retinal detachment with PVR and inferior breaks
15834560|NCT04167956|Device|ultrasound and CT|Experimental: ultrasound combined with CT guided Active Comparator: CT guided
15834516|NCT04168242|Device|Scalp cooling Paxman Orbis II system|The experimental arm will have scalp cooling that starts 30 minutes before the chemotherapy, continues throughout the infusion of the chemotherapy, and lasts for 20-90 minutes more depending on the type of regimen.
15834517|NCT04168242|Other|Standard treatment|The control arm will not have scalp cooling before, during and after chemotherapy.
15834518|NCT04168229|Device|Mermaid 9 ITE|A Hearing aid intended to amplify sounds and deliver them to the ear with a microphone and receiver housed in an in-the-ear hardware.
15834519|NCT04168229|Device|Mermaid 9 BTE|A Hearing aid intended to amplify sounds and deliver them to the ear with a microphone and Receiver housed in a behind-the-ear hardware.
15834520|NCT04168203|Drug|Apixaban 2.5 MG|apixaban 2.5 mg orally twice daily for a duration of 12 months
15834521|NCT04168203|Drug|Placebo oral tablet|placebo oral tables twice daily for a duration of 12 months
15834522|NCT04168190|Drug|pPCV|Single 0.5 or 1.0 mL IM injection
15834523|NCT04168190|Biological|Pneumovax™23|Single 0.5 mL IM injection
15834524|NCT04168177|Procedure|PCA|Patient controlled analgesia
15834525|NCT04168177|Procedure|ESP|erector spinae plane block
15834526|NCT04168164|Other|aquatic therapy|The exercises of Ai Chi were performed in a specific order, until completion of the total possible movements.
15834527|NCT04168164|Other|Dry land therapy|sessions including exercises for gait, trunk mobility and exercises involving the upper and lower limbs
15834528|NCT04168164|Other|Combined therapy|alternate sessions of therapy on dry land and aquatic therapy with Ai Chi
15834529|NCT04168151|Other|lung recruitment protocol|lung recruitment protocol applied to postcardiac surgery hypoxic adult patients with measurement of trans alveolar pressure as an index for lung recruitment
15834530|NCT04168138|Drug|rhTPO|D: Decitabine(15mg/m2) d1-5 G: G-CSF（300ug/d） d0-9(stop using when White Blood Cell (WBC)>20*109/L) T: rhTPO(15000U/d) d3,5,7,9, d11- (Platelet>50*109/L) A: Aclarubicin(10mg/d) d3-6 C: Cytarabine(15mg Q12h) d3-9
15834531|NCT04168125|Device|Tilapia skin|Application tilapia skin as an occlusive biological dressing for palatal wound healing after free gingival graft harvesting.
15834532|NCT04168125|Device|Surgical Wound Dressing|Application surgical wound dressing as an occlusive biological dressing for palatal wound healing after free gingival graft harvesting.
15834533|NCT04168112|Drug|Dextenza|Placement of intracanalicular dexamethasone insert for post-crosslinking inflammation and pain
15834534|NCT04168112|Drug|Prednisolone Acetate|post-crosslinking eye drop prednisolone acetate given in a tapering schedule over 1 month
15834535|NCT04168099|Drug|Cefotaxime|Cefotaxime IV
15834536|NCT04168099|Drug|Gemifloxacin|Gemifloxacin oral
15834537|NCT04168086|Other|Focused Ultrasound|Low intensity focused ultrasound is sound energy stimulation at a low intensity of 1-30 W/cm2
15834538|NCT04168086|Other|Sham|The investigators will simulate focused ultrasound stimulation similar to the experimental groups but without stimulation.
15834539|NCT04168073|Other|High-sodium diet 300 mmol sodium/day|Day 7 or day 21 high-sodium diet begins for 8 days. Day 15 wash-out begins for 6 days. Pre-made meals for both the high-and low-sodium diet will be provided to each participant by the study team.
15834540|NCT04168073|Other|Low-sodium diet 10 mmol sodium/day|Day 7 or day 21 low-sodium diet begins for 8 days. Day 15 wash-out begins for 6 days. Pre-made meals for both the high-and low-sodium diet will be provided to each participant by the study team.
15834541|NCT04168060|Procedure|Crura dissection|The diaphragmatic crura, one of two tendon structures below the diaphragm, will be removed during the laparoscopic sleeve gastrectomy.
15834542|NCT04168060|Procedure|Sleeve gastrectomy|Surgical weight-loss procedure in which the stomach is reduced to about 15% of its original size, by surgical removal of a large portion of the stomach along the greater curvature.
15834543|NCT04168060|Procedure|Hiatal hernia repair|This involves tightening the opening in your diaphragm with stitches to keep your stomach from bulging upward through the opening in the muscle wall.
15834544|NCT04168047|Procedure|Barostat procedure|Pressure threshold will be measured during the barostat procedure
15834545|NCT04168047|Other|Anxiety and Depression Evaluation|Anxiety and Depression will be measured using HAD anxiety and depression scale
15834546|NCT04168047|Other|Assessment of sleep quality|Sleep quality will be measured using Pittsburg sleep quality index
15834547|NCT04168034|Behavioral|iParent2Parent Program|In addition to standard care, parents in the experimental group will receive the iParent2Parent program. The iParent2Parent program is a tailored peer mentorship program that provides modeling and reinforcement by peers (trained parents of children with JIA) to parents of children diagnosed with JIA.
15834548|NCT04168034|Behavioral|Waitlist Control|The control group will receive standard care but without the iParent2Parent program
15834549|NCT04168021|Behavioral|Leg ischemia|potential neuroprotection of ischemia/reperfusion of a peripheral organ or tissue against cerebral I/R injury
15834550|NCT04168008|Behavioral|WISH Adherence|The educational sessions will consist of an adherence-centered curriculum.
15834551|NCT04168008|Behavioral|WISH Parenting|The educational sessions will focus on parenting and baby care.
15834552|NCT04167995|Drug|Probiotic Formula lacteal forte|Active Comparator: Patient with attention deficit hyperactive disorser patients (n=40) will receive probiotic preparation once daily (Lacteol Forte; Rameda, Egypt) as sachets containing 10 billion colony forming units (CFU) of Lactobacillus fermentum and Lactobacillus delbruekii for 12 weeks .
15834553|NCT04167982|Procedure|Aminolevulinic acid photodynamic therapy|Aminolevulinic acid photodynamic therapy
15834554|NCT04167982|Drug|Oral conventional-dose isotretinoin|Conventional-dose isotretinoin
15834555|NCT04167982|Drug|Oral low-dose isotretinoin|low-dose isotretinoin
15834556|NCT04167969|Drug|(64Cu)-labeled PSMA-targeting particle tracer, or 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots|Patients will be injected with approximately 5 mCi (+/- 10%) of a copper-64 (64Cu)-labeled PSMA-targeting particle tracer, or 64Cu-NOTA-PSMAi-PEG-Cy5.5-C' dots, up to 48 hours before surgery.
15834557|NCT04167969|Diagnostic Test|PET/MRI|Imaging will be performed using the GE Signa PET/MRI.
15834558|NCT04167969|Other|Blood and urine sampling|Staff will perform the IV blood draws and collect urine samples
15834559|NCT04167969|Procedure|laparoscopic radical prostatectomy and bilateral pelvic LN dissection or a salvage lymph node dissection|Surgery will be performed within 24 h of the third PET/MRI scan.
15834561|NCT04167943|Drug|Dual cured resin modified tricalcium silicate cement|A resin based, dual cured tricalcium silicate based cement
15834562|NCT04167930|Other|electronic medical record(EMR) Data and patient survey|"Retrospective Data Collection (1) Neck Disability Index (NDI), Oswestry Low Back Disability Index(ODI), euroqol-5 dimension(EQ-5D) scores during hospitalization (2) symptom onset date, symptom onset motive, past history, accident occurrence date, accident treatmen termination agreement date, etc.
~Question items (consistent with the case record) according to the purpose of the investigation (1) General: Demographic sociological characteristics (gender, age, occupation, income, etc.) (2) Matters concerning the correlation between traffic accident agreements and symptoms"
15834563|NCT04167917|Drug|NTX-301|oral hypomethylating agent
15834564|NCT04167891|Diagnostic Test|Calculation of early prognosis score|Early prognosis score will be calculated at intensive care unit admission for each patient based on clinical and biological values as required
15834565|NCT04167878|Device|3D printed biodegradable cervical fusion cage|ACDF with 3D printed biodegradable cervical interbody fusion cage for spinal fusion procedure at one level (C2 to T1) of the cervical spine.
15834566|NCT04167878|Device|PEEK cage|ACDF with PEEK cage for spinal fusion procedure at one level (C2 to T1) of the cervical spine.
15834567|NCT04167865|Other|Exercise|Orthosis, mobilization, strengthening, posture and segmental breathing exercises
15834568|NCT04167852|Behavioral|Daily text message|Patients will receive a daily text message stating how many days they have until or since their surgery.
15834569|NCT04167852|Behavioral|Mindfulness intervention|Patients will receive a link to mindfulness meditation intervention for ten minutes.
15834570|NCT04167839|Other|Sensory diet|Sensory diets are one of the interventions occupational therapists use in school-based settings to manage manifestations of sensory processing disorder. Sensory diets are composed of exercises and multisensory activities that are tailored for children and provide them sensorimotor experiences to facilitate their participation in daily activities.
15834571|NCT04167813|Drug|Ondansetron 8mg or matched placebo|Participants will take 8-24mg/day of ondansetron or matched placebo. The dose will increase from a single daily 8mg tablet (AM) (weeks 1 and 2), to 16mg/day (8mg twice daily) (weeks 3 and 4), with a further increase to 24mg/day (8mg AM, 16mg PM) (weeks 5 and 6).
15834572|NCT04167800|Other|Exercise|Orthosis, mobilization, strengthening, posture and segmental breathing exercises
15834573|NCT04167774|Drug|Camrelizumab|Camrelizumab will be administered as a 30-minute IV infusion Q3W at a dose of 200mg (3mg/kg for underweight patients).
15834574|NCT04167774|Drug|nb-Paclitaxel|nb-Paclitaxel will be administered as a 30-minute IV infusion Q3W at a dose of 260mg/m2 for 4-6 cycles.
15834575|NCT04167761|Drug|Ertugliflozin|Consenting participants in the Ertugliflozen group will be supplied with 2-week course of medication prior to cardiac surgery. Participants will be educated on use and have blood glucose monitored during the medication course. The surgeon will then collect a small amount of fat near the heart during surgery.
15834576|NCT04167761|Drug|Glipizide|Consenting participants in the Glipizide group will be supplied with 2-week course of medication prior to cardiac surgery. Participants will be educated on use and have blood glucose monitored during the medication course. The surgeon will then collect a small amount of fat near the heart during surgery.
15834577|NCT04167748|Procedure|Preimplantation genetic testing for aneuploidy (PGT-A)|24-chromosome screening for aneuploidy in the preimplantation embryo (blastocyst stage)
15834578|NCT04167735|Device|Hearing Aid without Reverberation Canceller (RevC).|Each participant will be fitted with the 2 different Sound Changing principles on the same hearing aid, saved to 2 manual programs (ensures exact same hearing loss compensation for each intervention). Reverberation Canceller principle is a sound processing algorithm to remove reverberation from a speech signal to improve the speech intelligibility and comfort. The active comparator condition is without Reverberation Canceller principle enabled.
15834579|NCT04167735|Device|Hearing Aid Reverberation Canceller enabled (RevC_1)|Each participant will be fitted with the 2 different Sound Changing principles on the same hearing aid, saved to 2 manual programs (ensures exact same hearing loss compensation for each intervention). Reverberation Canceller principle is a sound processing algorithm to remove reverberation from a speech signal to improve the speech intelligibility and comfort. The experimental condition applies the Reverberation Canceller and is predicted to provide a benefit in reverberant room simulations.
15834580|NCT04167722|Procedure|Robotic Radical Prostatectomy|Routine NHS Radical Prostatectomy
15834581|NCT04167709|Other|Education in clinical competence in detecting signs of postpartum depression in immigrant mothers|Groupbased educational intervention aimed at nurses in the Child Health Services in strengthening clinical competence in detecting signs of postpartum depression in non-native-speaking immigrant mothers
15834582|NCT04167696|Biological|CYAD-02|CYAD-02 is a Chimeric Antigen Receptor-T (CAR-T) administered after CYFLU.
15834583|NCT04167696|Drug|ENDOXAN|administered as preconditioning chemotherapy
15834584|NCT04167696|Drug|Fludara|administered as preconditioning chemotherapy
15834585|NCT04167683|Other|No intervention|No intervention
15834586|NCT04167670|Drug|Vonoprazan|Over-encapsulated tablets administered orally.
15834587|NCT04167670|Drug|Amoxicillin|Capsules administered orally.
15834588|NCT04167670|Drug|Clarithromycin|Tablets administered orally.
15834589|NCT04167670|Drug|Lansoprazole|Over-encapsulated capsules administered orally.
15834590|NCT04167657|Drug|Sintilimab|"Sintilimab 200mg IV, every 3 weeks, until progressive disease (PD), intolerable toxicity, or at a maximum of 12 months.
~Before enrollment, patient should undergo radiation no less than dose 30Gy/5f. Sintilimab shall be started no later than 3 weeks after radiation."
15834591|NCT04167644|Diagnostic Test|Modified Rankin Scale (mRS)|Modified Rankin Scale (mRS) is a profoundly valid and reliable measure of disability and is broadly utilized for assessing stroke outcomes and degree of disability. We characterized a favorable outcome as mRS ranging from zero up to two, while unfavorable outcome ranging for 3 up to six
15834592|NCT04167631|Radiation|Multi-parametric MRI|Vesical Imaging-Reporting And Data System (VI-RADS) for predicting non-muscle invasive bladder cancer (NMIBC) using multi-parametric MRI.
15834661|NCT04167137|Drug|Atezolizumab|Administered in accordance with its recommended dose and schedule (1200 mg IV Q3W) on Day 1 of each of the 4 planned 21-day cycles.
15834662|NCT04167124|Behavioral|multi-sensor lifestyle intervention|
15834594|NCT04167605|Other|Bone metastasis|Collection of waste tissue samples during surgery and immediate immersion of the same in 10% Neutral buffered formalin. The samples will be send to the laboratory where they will be processed (decalcification, inclusion in paraffin, sectioning etc.) for subsequent analyzes.
15834595|NCT04167605|Other|Breast cancer metastatic to bone|Patients will be assisted in the recovery of samples (slides) related to surgery on primary tumor (breast cancer responsible for metastatic disease).
15834596|NCT04167592|Drug|Benzydamine Hydrochloride 0.15% Oral Rinse|Benzydamine Hydrochloride 0.15% Oral Rinse was used to gargle prior to Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure.
15834597|NCT04167592|Drug|Water|Water was used to gargle prior to Endoscopic Retrograde Cholangiopancreatography (ERCP) procedure.
15834598|NCT04167579|Device|Transcutaneous Valve Therapy|Any patient who undergoes an attempted transcutaneous aortic or mitral valve therapy procedure, with an FDA approved device.
15834599|NCT04167566|Combination Product|Artemisinin Combination Therapy ACTs|All participants will be tested using RDTs and all confirmed cases will be treated with ACTs. The ACT regimen use at each time will be the one the National Malaria Control Programme will be using at that particular moment.
15834600|NCT04167553|Drug|HM15136|In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort. In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional.
15834601|NCT04167553|Drug|Placebo|In Part 1, approximately 36 subjects, divided into 3 cohorts with 12 subjects (HM15136 group 9 subjects, placebo group 3 subjects) per cohort. In Part 2, approximately 66 subjects, in up to 4 cohort with 30 subjects for cohort 4 (HM15136 group 15 subjects, placebo group 15 subjects) and 12 subjects per cohorts 5-7 (HM15136 group 9 subjects, placebo group 3 subjects). Cohorts 6 and 7 are optional.
15834603|NCT04167527|Device|Immediate mechanical thrombectomy(iMT) using EmboTrap II Revascularization Device|Treatment initiation is defined as the date and time of arterial puncture. Femoral artery puncture will occur within 45 minutes of randomization and no longer than 90 minutes after the completion of the qualifying imaging. It must occur before 8 hours since the subject was last known well.The initial procedure will be performed using only the EmboTrap II Retriever for the first two passes, and a third pass is encouraged. Date and time of arterial puncture, revascularization, and procedure end will be recorded. It is expected that the interventional procedure will be completed within two hours of arterial access.
15834604|NCT04167527|Combination Product|Initial medical management (iMM)|Patients will receive standard medical therapy based on current AHA guidelines. For patients who are treated with intravenous tissue plasminogen activator (rtPA), the sites' post-rtPA protocol will be followed. Rescue mechanical thrombectomy (rMT) is allowed for patients initially assigned to iMM if they suffer major neurological worsening that clearly requires an intra-arterial intervention in the judgment of the treating team.
15834607|NCT04167501|Other|biological sample analysis|HPV Prevalence analysis
15834608|NCT04167488|Device|Actigraphic measurement|Physical activity assessed with actigraphic device worn during 7 days
15834609|NCT04167475|Dietary Supplement|Probiotic capsule|Each probiotic capsule contains 1 x 10^9 CFU B. longum 1714™ with corn starch and magnesium stearate. The probiotic capsules will be supplied by PrecisionBiotics Ltd.
15834610|NCT04167475|Dietary Supplement|Placebo capsule|Each placebo capsule contains corn starch and magnesium stearate. The placebo capsules will be supplied by PrecisionBiotics Ltd.
15834611|NCT04167462|Drug|BMS-986165|Specified dose on Specified Days
15834612|NCT04167462|Other|Placebo|Specified dose on Specified days
15834613|NCT04167449|Dietary Supplement|HRG80 Hydroponic Red Ginseng|Powdered root preparation of Panax ginseng standardized to 31.7 mg total ginsenosides
15834614|NCT04167449|Dietary Supplement|Conventional White Ginseng|Powdered root preparation of Panax ginseng standardized to 9.8 mg total ginsenosides
15834615|NCT04167449|Dietary Supplement|Placebo|Visually identical placebo capsule containing rice flour
15834616|NCT04167436|Other|Prehabilitation|A minimum of four weeks of prehabilitation with exercise three times a week, protein and vitamin supplements, dietitian consultation and medical optimization prior to surgery.
15834617|NCT04167410|Other|glycaemic management protocol implemented to clinic|Following the introduction of the glycaemic management protocol to the clinic, data on the patients in the intervention group was collected prospectively between June 2018 and December 2018. Data of the patients in the intervention group was collected after the patient applied to the hospital for surgery or just after the decision on surgery was taken. Patients in the intervention group whose HbA1C values exceeded 7% were referred to endocrinology specialists prior to surgery. Glycaemic management of these patients was evaluated at the department of endocrinology and medications or doses of insulin and oral antidiabetics were changed when necessary. Glycaemic management was conducted by nurses in line with the protocolConsequently, the glycaemic management of patients during the perioperative period was conducted by general surgery nurses according to the protocol.
15834618|NCT04167397|Other|Collaborative learning|Participants will be allocated to either single, dyad, triad or tetrad practice during initials skills training on an ultrasound simulator. Afterwards their competencies will be assessed with an individual transfer test on another simulator.
15834619|NCT04167384|Other|Product A|Usual brand (UB) filtered, combustible cigarette
15834620|NCT04167384|Other|Product B|Nicorette® Mint 4 mg nicotine lozenge
15834621|NCT04167384|Other|Product C|CSD1903-11, a hard nicotine lozenge, 2 mg nicotine
15834622|NCT04167384|Other|Product D|CSD1903-11, a hard nicotine lozenge, 4 mg nicotine
15834623|NCT04167384|Other|Product E|CSD1903-11, a hard nicotine lozenge, 8 mg nicotine
15834624|NCT04167384|Other|Product F|CSD1903-12, a soft nicotine lozenge, 2 mg nicotine
15834625|NCT04167384|Other|Product G|CSD1903-12, a soft nicotine lozenge, 4 mg nicotine
15834626|NCT04167384|Other|Product H|CSD1903-12, a soft nicotine lozenge, 8 mg nicotine
15834663|NCT04167111|Dietary Supplement|Cholecalciferol|Vitamin D
15834627|NCT04167371|Behavioral|Biofeedback|Three sessions by biofeedback will be performed during the first 3 weeks of the intervention period. In each session patients will be taught to control abdominal and thoracic muscular activity by providing a visual display of the abdominal and thoracic perimeter; patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period.
15834628|NCT04167371|Dietary Supplement|Placebo|Three sessions will be performed during the first 3 weeks of the intervention period. In each session abdominal and thoracic perimeter will be recorded but not shown to the patient; patients will take a pill of placebo containing 0.5 g glucose and no specific instructions will be provided. Patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period.
15834629|NCT04167358|Drug|Linerixibat|All participants will receive linerixibat.
15834630|NCT04167345|Drug|VX-814|Tablet for oral administration.
15834631|NCT04167345|Drug|Placebo|Placebo matched to VX-814 for oral administration.
15834632|NCT04167319|Other|QST and PRO measurements during treatment|We will observe the natural course of CIPN using multiple measurements
15834633|NCT04167306|Drug|Varenicline Tartrate 1 mg b.i.d|Capsules for oral use
15834634|NCT04167306|Drug|Bupropion Hydrochloride 150 mg b.i.d|Capsules for oral use
15834635|NCT04167306|Other|Placebo for varenicline|Capsules for oral use
15834636|NCT04167306|Other|Placebo for bupropion|Capsules for oral use
15834637|NCT04167293|Radiation|stereotactic body radiotherapy|Patients will receive stereotactic body radiotherapy (SBRT) using volumetric arc therapy. The prescribed dose is 30-54 Gy in 3-6 fractions over 1-2 weeks.
15834638|NCT04167293|Drug|Sintilimab|Sintilimab is administered intravenously at 200 mg every 3 weeks for up to 1 year. The first course of sintilimab will be given within 4-6 weeks after completion of SBRT.
15834639|NCT04167280|Drug|Ipratropium Metered Dose Inhaler|MDI to deliver 20mcg per puff ipratropium bromide
15834640|NCT04167280|Drug|placebo metered dose inhaler|matched MDI to deliver inactive drug
15834641|NCT04167267|Drug|DWP14012 tablet A|Period 1: DWP14012 tablet B Period 2: DWP14012 tablet A
15834642|NCT04167267|Drug|DWP14012 tablet B|Period 1: DWP14012 tablet A Period 2: DWP14012 tablet B
15834643|NCT04167254|Behavioral|Sit Down and Play|Brief health care-based program that aims to promote key parenting behaviors that promote early childhood development
15834644|NCT04167241|Diagnostic Test|Echocardiography|Before and after right pneumonectomy or bi-lobectomy patients will receive echocardiography
15834645|NCT04167228|Drug|Ceftazidime-Avibactam|Patients with complicated urinary tract infections, nosocomial pneumonia (including pneumonia associated with ventilation), complicated intra-abdominal infections or bacteremia (if the focus of infection is any of the above, the patient should be included in both groups) due to CRE, treated > 2 days with ceftazidime-avibactam.
15834646|NCT04167228|Drug|Best Available Therapy|Patients with complicated urinary tract infections, nosocomial pneumonia (including pneumonia associated with ventilation), complicated intra-abdominal infections or bacteremia (if the focus of infection is any of the above, the patient should be included in both groups) due to CRE, treated > 2 days with the best available treatment other than ceftazidime-avibactam.
15834647|NCT04167215|Procedure|superior gluteal artery flap and lumbar artery falp|Doppler ultrasound will be used to confirm location of the superior gluteal artery perforators or lumbar perforators . Flaps will be designed to allow deepithelialization and dissection . After complete sketolization of the flap it will be analyzed for viability and trimmed to achieve the desired bulk.
15834648|NCT04167215|Procedure|The gluteal pocket|pocket will be created by undermining in a plane just superficial to the gluteal muscle from the lower body lift line inferiorly extending to within 5 cm of the inferior gluteal crease. should extend only over the medial half of the buttock.
15834649|NCT04167215|Procedure|infragluteal dermal lifiting flap|dermal flap will be performed for lifting the ptotic buttocks with ill-defined infragluteal fold. This deepithelialized dermal flap allows for the creation of a well-defined stable infragluteal fold through an incision of the infragluteal fold and exposure of ischial tuberosity and anchor it to the ischial tuberosity.
15834650|NCT04167202|Procedure|Hydrogen-rich water|Hydrogen-rich water (one hydrotherapy every 4 hours)
15834651|NCT04167202|Procedure|RICE|RICE protocol
15834652|NCT04167189|Drug|Lidocaine gel|Septodont 5% oral lidocaine gel (NDC 0362-0221-10), 75 mg
15834653|NCT04167176|Procedure|Erector spinae plane block|Patients will be placed on their right side. A high-frequency linear ultrasound probe will be placed in a longitudinal parasagittal orientation 2.5-3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. A 21G 10-cm needle will be inserted using an in-plane approach in a cranial to caudal direction. The tip of the needle will be placed into the fascial plane on the deep aspect of the erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting the erector spinae muscle off the bony shadow of the transverse process on ultrasonographic imaging. A volume of 20 mL of LA mixture (10 mL of bupivacaine 0.5%, 5 mL of lidocaine 2% and 5 mL of normal saline to make a mixture totaling 20 ml.) will be injected. The same procedure will be repeated for the opposite side.
15834654|NCT04167176|Procedure|Port site infiltration|After the induction of anaesthesia, pre-incisional port-site infiltration will be performed by the same surgeon every time with 20 ml of the LA mixture. The volume will be divided equally between port sites. A total of four ports-supraumbilical, subxiphoid and two ports in the right subcostal area at mid-clavicular and anterior axillary line will be made.
15834655|NCT04167176|Device|Ultrasound machine (Mindray DP 9900 plus; Mindray Bio-Medical Electronics, Shenzhen, China)|Ultrasound will be used to identify the erector spinae muscles and to guide the LA mixture injection.
15834656|NCT04167176|Drug|Bupivacaine 0.5%|Bupivacaine 0.5% will be included in the injected LA mixture.
15834657|NCT04167176|Drug|Lidocaine 2%|Lidocaine 2% will be included in the injected LA mixture.
15834658|NCT04167163|Drug|Abaloparatide|18 month ABL treatment
15834659|NCT04167150|Dietary Supplement|tart cherry juice concentrate is a commercial product provided by King Orchards (Central Lake, MI)|Participants were instructed to reconstitute the tart cherry juice concentrate in 8 fl oz of water and consume either 1x or 2x daily for 3 months.
15834660|NCT04167137|Drug|SYNB1891|Up to four 21-day cycles of escalating doses of SYNB1891 intratumoral injection on Days 1, 8 and 15 of Cycle 1 and Day 1 of cycles 2-4.
15834664|NCT04167098|Other|PRP injection|0.5 ml Platelet-rich Plasma around A1 tendon sheath
15834665|NCT04167098|Other|Corticosteroid injection|0.5 ml methylprednisolone around A1 tendon sheath
15834666|NCT04167098|Other|Placebo injection|0.5 ml 0.9% saline around A1 tendon sheath
15834667|NCT04167085|Drug|Doxycycline|Doxycycline, 100 mg twice a day for 2 months
15834668|NCT04167085|Other|Placebo|Matching placebo, twice a day for 2 months
15834669|NCT04167072|Procedure|Stent removal|This is a procedural intervention in which the stent will be removed via endoscopy.
15834670|NCT04167059|Behavioral|Telehealth-delivered participation strategies to increase physical activity|Therapists and primary caregivers will meet online on 6 occasions at fortnightly intervals over a 12 week period. Sessions will enable the development of strategies that will aim to increase the amount the participant stands and walks. Throughout, the therapists and primary caregivers will discuss physical activity needs, determine relevant activities, modify the program as necessary and plan additional goals.
15834671|NCT04167046|Procedure|Erector spinae block|Preoperative erector spinae block.
15834674|NCT04167020|Device|High definition surface electromyography (HD-sEMG)|HD-sEMG data will be collected by Mobita 32® (TMSi) device
15834675|NCT04167007|Drug|Gemcitabine|Gemcitabine at 1000 mg/m² as intravenous (IV) infusion over 30-40 minutes on days 1, 8, and 15, followed by 1 week of rest, every 28 days
15834676|NCT04167007|Drug|FOLFOX|Oxaliplatin at 85 mg/m² given as a 2 hours IV infusion on days 1 and 15; Folinic acid 400 mg/m² (racemic form) or 200 mg/m² (L-form) in 250 ml glucose 5% solution given as a 2 hours IV infusion on days 1 and 15; and 5-FU 2400 mg/m² administered as continuous 46-hour IV infusion on days 1-3 and 15-17, every 28 days.
15834677|NCT04166994|Behavioral|Exercise and diet|IMPACT Intervention
15834678|NCT04166994|Other|No Intervention: Usual Care|No exercise or diet specialization.
15834679|NCT04166981|Procedure|Instrumented posterolateral spine fusion.|Posterolateral fusion with autologous and allogenic bone graft with supplementary pedicle screw fixation.
15834680|NCT04166981|Procedure|Non-instrumented posterolateral spine fusion.|Posterolateral fusion with autologous and allogenic bone graft.
15834681|NCT04166968|Device|Anodal transcranial direct current stimulation (A-tDCS)|Anodal tDCS will be performed for 20 minutes over the affected hemisphere with an intensity set to 2 mA
15834682|NCT04166968|Device|Cathodal transcranial direct current stimulation (C-tDCS)|Cathodal tDCS will be performed for 20 minutes over the unaffected hemisphere with an intensity set to 2 mA
15834683|NCT04166968|Device|Sham stimulation (sham-tDCS)|placebo stimulation
15834684|NCT04166968|Behavioral|Neuromotor training|conventional neuromotor treatment
15834685|NCT04166955|Behavioral|Promoting Physical Activity through mobile application|Students will be randomly assigned to either the intervention or the control group. WhatsApp groups will be formed within each study group. The control participants will have the WhatsApp group only for communications. And they will keep their usual activity for 10 weeks. The intervention participants will have the intervention WhatsApp group which will be for communication and providing the intervention materials. The intervention group will receive a brief (15-minute) orientation on exercise, and benefits of keeping a healthy life pattern. They will receive 3-4 health-promotional (Physical activity) messages per week via WhatsApp for 10 weeks; group interaction is optional without adding more messages aiming to promote physical activities from any participants.
15834686|NCT04166942|Drug|KD025|Single dose of 200 mg KD025 orally
15834689|NCT04166916|Other|Acoustic stimulation|Acoustic stimulation to modulate slow waves.
15834690|NCT04166916|Other|SHAM acoustic stimulation|This is the sham-control intervention; only the biosignal will be recorded but no acoustic stimulation will be played.
15834691|NCT04166890|Drug|Articaine / EPINEPHrine Cartridge|The day scheduled for the surgery, vital signs (pulse, blood pressure and oxygen saturation) will be recorded prior the administration of the anesthesia. A volume of 1.8 ml of 4% articaine and epinephrine 1: 100000 solution of either the test product or the reference product will be deposited slowly to proceed to the inferior alveolar nerve block (IANB), according to the table of allocation of treatments in each period. The vital signs will continue to be monitored during the procedure, and once the procedure has been completed. If the volunteer needs more anesthetic, this will be recorded and will be administrated according to the maximum permitted doses (7 mg / kg (up to 500 mg) 5 mg / kg in children 7), and immediately after the administration, the vital signs will be taken again.
15834692|NCT04166877|Drug|Magnesium Sulfate in Parenteral Dosage Form|IV bolus followed by continuous infusion for 24 hours
15834693|NCT04166877|Drug|Normal saline placebo|IV bolus followed by continuous infusion for 24 hours
15834694|NCT04166864|Device|Transcranial magnetic Stimulation|Transcranial magnetic stimulation delivered at the Subject's SCC-determined frequency. Each Subject will receive 40 pulses every 26 seconds, over 75 trains.
15834695|NCT04166851|Behavioral|PrEP campaign messages developed via open contest|PrEP campaign messages will be developed via an open contest in Baltimore.
15834696|NCT04166851|Behavioral|PrEP campaign messages developed via social marketing approach|PrEP campaign messages developed with a traditional social marketing approach.
15834761|NCT04166513|Behavioral|Semantic-Focused Speech Therapy|Participants who have difficulty retrieving an object name are given hierarchical clues or asked questions about the objects function as a way of activating the semantic network for that object, leading to eventual retrieval of the target word.
15834762|NCT04166500|Procedure|Hysteroscopy|outpatient hysteroscopy after the first menstrual cycle in the follicular phase (9-12 days).
15834763|NCT04166487|Drug|Pembrolizumab|predetermined dose, once per cycle via IV will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle.
15834697|NCT04166838|Biological|CD19 UCARTcells|This study did not set up a control group. The maximum dose was determined according to the dose escalation test. Based on the number of CART cells per kg body weight which was proved to be safe and effective, all the subjects were treated with one single dose of CD19 UCART cells per treatment course. The dose escalation test was designed to evaluate the three dose levels of CD19 UCART (1 × 10 ^ 6 cells/kg,3 × 10 ^ 6 cells/kg,5 × 10 ^ 6 cells/kg). Each CD19 UCART infusion will be carried out on day 0. Each subject was observed for at least 4 weeks after the last infusion. If there was no dose-limited toxicity (DLT), it is necessary to continue multiple treatment courses at this dose level. The detailed administration time and dose were decided by the researchers.
15834698|NCT04166825|Diagnostic Test|fibrin clot properties|Assessment of thrombin generation and efficiency of fibrinolysis.
15834699|NCT04166812|Diagnostic Test|oscillometry|assessment of peripheral airway resistance using oscillometry
15834700|NCT04166812|Diagnostic Test|multiple breath washout testing|assessment of ventilation heterogeneity using multiple breath washout testing
15834701|NCT04166812|Diagnostic Test|spirometry|assessment of lung function using spirometry
15834702|NCT04166812|Diagnostic Test|body plethysmography|assessment of lung function using body plethysmography
15834703|NCT04166812|Diagnostic Test|fractional exhaled nitric oxide|assessment of eosinophilic airway inflammation using fractional exhaled nitric oxide
15834704|NCT04166812|Diagnostic Test|transfer factor|assessment of gas transfer using single breath transfer factor for carbon monoxide
15834705|NCT04166812|Diagnostic Test|health status|assessment of health status using validated questionnaires (St. George's Respiratory Questionnaire [SGRQ], COPD Assessment Test [CAT])
15834706|NCT04166812|Diagnostic Test|computed tomography|assessment of lung structure and function using computed tomography (only in patients with clinical indication, Heidelberg site)
15834707|NCT04166812|Diagnostic Test|induced sputum|various biomarkers (subgroup of approximately 75 patients, Großhansdorf site)
15834708|NCT04166799|Device|Mepitel Film|Mepitel® Film is a thin, soft and conformable transparent film dressing with Safetac®, offering protection for vulnerable skin.
15834709|NCT04166786|Drug|Testosterone gel|Subjects receive a daily transdermal dose of 100 mg of testosterone (2 sachets of 5 g of gel) during 3 days.
15834710|NCT04166786|Drug|Ethanol Solution|Subjects receive a daily administration of 30 g of ethanol (94 mL of Vodka Absolut® diluted in 300 mL of lemon-flavoured water Fontvella®) during 3 days.
15834711|NCT04166786|Drug|Testosterone placebo (vaseline)|Subjects receive a daily transdermal dose of 5 g of pure vaseline ointment during 3 days.
15834712|NCT04166786|Drug|Ethanol placebo (lemon-flavoured water)|Subjects receive a daily administration of 394 mL of lemon-flavored-water Fontvella® during 3 days.
15834715|NCT04166760|Dietary Supplement|speWHE|25 gram of a specific whey fraction (confidential)
15834716|NCT04166760|Dietary Supplement|WHE|25 gram protein of a regular whey compound
15834717|NCT04166747|Other|Virtual Reality experience|Participants will receive virtual reality based experience and will be assessed for its influence on happiness, functional fitness components and quality of life of older age groups.
15834718|NCT04166734|Drug|Pembrolizumab|"Pembrolizumab will be continued dosed at 200 mg given every 3 weeks
~Drug: Pembrolizumab Pembrolizumab in week 1 dosed at 200 mg (prior to SBRT) and then treatment with pembrolizumab will be continued dosed at 200 mg given every 3 weeks."
15834719|NCT04166734|Radiation|Stereotactic Body Radiotherapy (SBRT)|Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#)
15834720|NCT04166721|Drug|Atezolizumab|Immunotherapy
15834721|NCT04166695|Device|Monolithic / facially veneered zirconia fixed partial denture|Participant receives one monolithic / facially veneered zirconia fixed partial denture retained by either teeth, implants or teeth and implants for the replacement of two neighbouring posterior teeth.
15834722|NCT04166695|Device|Completely veneered CoCr fixed partial denture|Participant receives one completely veneered CoCr fixed partial denture retained by either teeth, implants or teeth and implants for the replacement of two neighbouring posterior teeth.
15834723|NCT04166682|Behavioral|Home-based cardiac rehabilitation|cardiac rehabilitation done at home
15834724|NCT04166682|Behavioral|Routine care|Routine care and followup
15834725|NCT04166669|Drug|APX001|Cohort 1 Day 1: APX001 500 mg IV BID over a 3-hour infusion; Day 18: APX001 500 mg IV BID over a 3-hour infusion. Cohort 2 Day 1: APX001 1000 mg IV BID over a 3-hour infusion; Day 24: APX001 1000 mg IV BID over a 3-hour infusion.
15834726|NCT04166669|Drug|Itraconazole|Cohort 1 Days 15-30: itraconazole 200 mg oral solution QD.
15834727|NCT04166669|Drug|Rifampin|Cohort 2 Days 15-33: rifampin 600 mg oral QD.
15834728|NCT04166656|Biological|Trumenba®|Trumenba® (Pfizer): Suspension for intramuscular injection in 0.5 mL single-dose prefilled.
15834729|NCT04166656|Biological|Bexsero®|Bexsero® (GSK): available as a suspension for intramuscular injection in a prefilled syringe
15834730|NCT04166643|Behavioral|WHHIP PLUS|Worksite health promotion and occupational health and safety (total worker health)
15834731|NCT04166643|Behavioral|Education only control|Education at the start of the project
15834732|NCT04166630|Device|Clinical Electrical Stimulator|Conductive electrodes will be on the skin at each end of the tested muscle(s). Each subject will have two target muscle groups tested (extensor carpi radialis longus, and tibialis anterior). Each muscle will be stimulated at three separate stimulation frequencies (2 Hz, 4 Hz, and 6Hz) over 3 minutes each, for a total of 9 minutes of stimulation per muscle. The clinical electrical stimulator will deliver mild electrical stimulations to the muscle (20-100 mA).
15834733|NCT04166617|Other|Conventional therapy|conventional physcial therapy rehabilitation for the upper limb
15834734|NCT04166617|Other|Leap motion plus conventional therapya|leap motion plus conventional physcial therapy rehabilitation for the upper limb
15834764|NCT04166487|Drug|PEMETREXED|administered per standard practice, once per cycle via IV will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle.
15834765|NCT04166487|Drug|CARBOPLATIN|administered per standard practice once per cycle via IV will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle.
15834895|NCT04165421|Behavioral|Family intervention group|Education and Family conversations
15834735|NCT04166604|Drug|Trifluridine/Tipiracil|"after morning and evening meal,
~Days 1 through 5: 35mg/m2 (twice daily)
~Days 6 through 7: recovery
~Days 8 through 12: 35mg/m2 (twice daily)
~Day 13 through 28: recovery
~In case of first event of grade 3-4 neutropenia : patients will not have a dose reduction and will receive a secondary prophylaxis with G-CSF (filgrastim or lenograstim) during subsequent cycle: a starting 5 mg/kg/day dose of filgrastim or lenograstim as a single daily injection, for 5 days, from day 14 to day 18
~In case of secondary event of grade 3-4 neutropenia despite G-CSF secondary prophylaxis, dose adjustment of trifluridine/tipiracil will be done according to Summary of Product Characteristics (SmPC). G-CSF secondary prophylaxis will be continuing with the reduction.
~dose"
15834736|NCT04166591|Behavioral|Overheard Speech|New words are introduced with the child as a bystander rather directly taught.
15834737|NCT04166591|Behavioral|Addressed Speech|New words are introduced directly to the child by an experimenter.
15834738|NCT04166578|Drug|lignocaine|The group of 62 patients undergoing cataract surgery received Mydrane (Mydrane group) or a combination of 1% solution of lignocaine and 0.025% solution of adrenalin (reference group) as an intraocular anesthetic
15834739|NCT04166578|Procedure|Phacoemulsyfication|Phacoemulsification is a technic of cataract surgery in which the eye's internal lens is emulsified with an ultrasonic handpiece and aspirated from the eye.
15834740|NCT04166578|Procedure|Intraocular lens implantation|An intraocular lens implant is a synthetic, artificial lens placed inside the eye that replaces the focusing power of a natural lens that is surgically removed, usually as part of cataract surgery.
15834741|NCT04166578|Behavioral|Visual Analog Scale for Pain|VAS for Pain is a new tool developed to assess the pain in quantitative terms.
15834742|NCT04166578|Behavioral|Brief Pain Inventory-short form|BPI short form is a tool developed to assess the pain in quantitative terms. The BPI allows patients to rate the severity of the pain and the grade to which their pain interferes with common dimensions of feeling and function.
15834743|NCT04166578|Diagnostic Test|Best corrected visual acuity measurment|Measurement of the best vision correction that can be achieved, such as glasses, as measured on the standard Snellen eye chart. For example, if your uncorrected eyesight is 20/200, but you can see 20/20 with glasses, your BCVA is 20/20.
15834744|NCT04166578|Diagnostic Test|Slit-lamp biomicroscopy|Slit-lamp biomicroscopy allows study of ocular structures and their relationships.
15834745|NCT04166565|Drug|Daratumumab|Daratumumab 16 mg/kg will be administered by i.v. infusion. Daratumumab will be administered weekly in Cycles 1 and 2, then every 2 weeks for Cycles 3-6, and thereafter every month up to 36 months.
15834746|NCT04166565|Drug|Bortezomib|Bortezomib 1.5 mg/m2 bortezomib will be administered by a subcutaneous injection once weekly (Days 1, 8, 15 and 22) in all cycles.
15834747|NCT04166565|Drug|Cyclophosphamide|"Cyclophosphamide 300 mg/m2 will be administered as a p.o. or i.v. weekly dose (Days 1, 8, 15, and 22) in every 28-day cycle (maximum weekly dose 500 mg).
~Dexamethasone will be administered on Days 1, 2, 8, 9, 15, 16, 22 and 23 in all cycles. On daratumumab infusion days dexamethasone may be administered i.v. or p.o. approximately 1 hour before the daratumumab infusion. On days when daratumumab is not administered, dexamethasone is to be administered p.o."
15834748|NCT04166565|Drug|Dexamethasone|Dexamethasone will be administered on Days 1, 2, 8, 9, 15, 16, 22 and 23 in all cycles. On daratumumab infusion days dexamethasone may be administered i.v. or p.o. approximately 1 hour before the daratumumab infusion. On days when daratumumab is not administered, dexamethasone is to be administered p.o.
15834751|NCT04166539|Behavioral|Questionnaires|You will be asked to complete a questionnaire about your family history of neurological diseases and current and past physical thinking activities.
15834752|NCT04166539|Behavioral|Interviews|Behavioral and Memory interviews will take place with the patient.
15834753|NCT04166539|Other|Blood draw|Have a sample of blood drawn (4.2-5 tablespoons) for clinical and research tests.
15834754|NCT04166539|Radiation|Magnetic Resonance Imaging|Each MR examination takes about 45 minutes and does not require the use of needles, medication or contrast enhancement. You will lie on your back and enter the MR scanner for the study, during which time you will hear knocking noises. People with pacemakers, aneurysm clips, cochlear implants, or metal/foreign objects in their eyes are not permitted to undergo MR studies. We will review your implants and determine your eligibility.
15834755|NCT04166539|Diagnostic Test|Echocardiogram|Each echocardiogram takes about 30 minutes. This test uses sound waves to look at your heart. The person doing the test will press on your chest with a machine to obtain the pictures. The pressure may be uncomfortable. The echocardiogram will involve an image enhancement agent infusion to obtain better images.
15834756|NCT04166526|Device|FDNIRS-DCS|FDNIRS-DCS measurements will be performed at the same time as all MRI scans. Participants in Group 4 will have additional measurements before, during, and after the their scheduled transfusion.
15834757|NCT04166526|Device|MRI|Participants in Groups 1-3 will receive a single, hour-long MRI. Participants in Group 4 will receive two, one hour long MRI scans: one within a week prior to their transfusion and one within a week after their transfusion.
15834758|NCT04166513|Device|Targeted Transcranial Direct Current Stimulation|High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes, and stimulation will be applied to the targeted region.
15834759|NCT04166513|Device|Active Control Transcranial Direct Current Stimulation|High-Definition-tDCS will be delivered via a battery-driven constant direct current stimulator (Soterix) using a 4x1 montage (1 central anodal electrode and 4 cathodal electrodes) arranged in a HD-cap. The current is turned on and increased in a ramplike fashion over approximately 30 seconds until reaching a strength of no more than 2mA, with a current density equal to 0.08mA/cm2. Stimulation will be maintained no longer than 20 minutes, and stimulation will be applied to the active control region.
15834760|NCT04166513|Behavioral|Phonologic-Focused Speech Therapy|Participants are asked to generate or choose from a list phonologic information about a target picture.
15834766|NCT04166487|Drug|PACLITAXEL|administered per standard practice once per cycle via IV will be administered every 3 weeks, with 21 consecutive days defined as a treatment cycle.
15834767|NCT04166487|Diagnostic Test|InVision|Plasma draw for clinical test performed at C1D1 and C2D1; plasma draw for research testing performed at other timepoints per protocol.
15834768|NCT04166474|Drug|Dolutegravir|Dosed at 50 mg bd on 3 separate occasions with low, medium and high doses of rifampicin. Dosed at 50 mg od without rifampicin.
15834769|NCT04166461|Other|Not application, observational study|Not application, observational study
15834770|NCT04166448|Other|Fetal MRI|The MRI examination added by this research, without injection or sedation, induces no risk for the mother as for the fetus(es)
15834771|NCT04166435|Drug|Temozolomide + Olaparib|Temozolomide (75 mg/m2 orally on days 1-7 every 3 weeks) + Olaparib (150 mg orally twice daily days 1-21) in a 21-day cycle.
15834772|NCT04166422|Other|Cardiac rehabilitation program|Aerobic treatment plus strength exercises
15834773|NCT04166422|Other|Experimental intervention|Aerobic treatment plus strengh exercises plus virtual reality
15834779|NCT04166396|Dietary Supplement|Resveratrol|500 mg resveratrol, BID
15834780|NCT04166396|Dietary Supplement|NR|500 mg NR BID
15834781|NCT04166396|Dietary Supplement|Placebo|Placebo
15834782|NCT04166383|Biological|VB-111|1E13 or 0.7E13 VP via IV infusion on Day 1 of cycle 1 and continue every 6 weeks
15834783|NCT04166383|Drug|Nivolumab|240 mg of nivolumab via IV infusion on Day 1 of each cycle starting on cycle 2 and continue every 2 weeks
15834784|NCT04166370|Other|Control|The standard of care includes nutrition and health services provided to all pregnant women and mothers of children under-2 as provided by the GoB and their supporting partners. Services that should be provided include clinic-level infant and young child feeding (IYCF) counseling, growth monitoring and promotion, immunization, iron and folic acid distribution for pregnant women, ANC, safe delivery at community and referral for complications, vitamin-A supplements for postpartum women and children, deworming and management of common childhood illness.
15834785|NCT04166370|Other|Strengthened (Services and SBCC)|"Strengthening referrals to health services- Needed improvements to existing health referral networks will be assessed, identified and implemented. Peer leaders will refer PLW to nearby service delivery points.
~Improving quality of health/nutrition services- Health-related service providers will be trained and supervised on nutrition best practices.
~SBCC- Primarily target PLW. Delivered using traditional and digital channels. Text/voice messages will be sent to PLW twice per week. Family members (e.g. husband) will also be encouraged to sign up for these messages. Female community nutrition promoters will also be deployed; delivering SBCC during group meetings and in health facilities. Mothers' groups will be established, and will be led by peer leaders, mentored in the delivery of messages on nutrition behavior."
15834786|NCT04166370|Other|Strengthened (Services and SBCC) + CCT|Will include all components of the strengthened intervention and participants will receive monthly cash transfers, which is about 25% of monthly consumption expenditure among poor rural households in Bangladesh. Cash transfers will begin when a woman enrolls (at any time during her pregnancy or until 2 months after giving birth). The monthly transfer will continue until a child is 12 months of age, thereby supporting mothers during the critical period of complementary food introduction. The transfer is contingent on having had a minimum of 4 ANC visits and monthly participation in mother's group SBCC sessions.
15834787|NCT04166357|Diagnostic Test|neuromuscular ultrasound|Neuromuscular ultrasound refers to a field in medicine in which ultrasound is used to diagnosis and guide treatment for people with neuromuscular diseases. Neuromuscular ultrasound is often combined with electrodiagnosis, and particularly nerve conduction studies and EMG, to improve the accuracy of diagnosis and add anatomic information to the functional information obtained with electrodiagnosis. It has been demonstrated that neuromuscular ultrasound adds value to the diagnosis of nerve disease in over 80% of cases.
15834788|NCT04166344|Behavioral|Happyair Ecosystem|"Happyair Ecosystem is a Smart Community for the integral care of patients with chronic or rare respiratory diseases such as Asthma, COPD or Alfa-1.
~Our community provides online & offline training and resources in digital health and social care to patients, family, caregivers, healthcare professionals and researchers.
~Using our platform, all of our members will be able to connect in order to improve the health and well-being of patients, learn to manage self-care, ensure an active lifestyle, and contribute to the development of current and future research projects."
15834789|NCT04166331|Drug|Placebos|Placebo will initially be started at a dose of 2.5 µg/kg/min and subsequently titrated using incremental steps (predefined durations) of 2.5 µg/kg/min, up to a maximal dose of 10 µg/kg/min. Dose adaptation will be left at the discretion of attending physician.
15834790|NCT04166331|Drug|Dobutamine|Dobutamine will initially be started at a dose of 2.5 µg/kg/min and subsequently titrated using incremental steps (predefined durations) of 2.5 µg/kg/min, up to a maximal dose of 10 µg/kg/min. Dose adaptation will be left at the discretion of attending physician.
15834791|NCT04166318|Drug|Capecitabine|Given PO
15834792|NCT04166318|Drug|Fluorouracil|Given IV
15834793|NCT04166318|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
15834794|NCT04166318|Drug|Mitomycin|Given IV
15834795|NCT04166318|Other|Quality-of-Life Assessment|Ancillary studies
15834796|NCT04166318|Other|Questionnaire Administration|Ancillary studies
15834797|NCT04166305|Genetic|Genetic study for SCN1A c.3184 A/G and CCL2-2518G>A polymorphism:|"DNA analysis: Genomic DNA will be extracted from EDTA-anticoagulated peripheral blood (QIAamp DNA Blood mini kit,QIAGEN).
~Genotyping of SCN1A c.3184 A/G(rs2298771) polymorphism"
15834798|NCT04166292|Device|Stylage® XL Lidocaïne|"On V1 (D0), a total volume of 8 mL maximum can be used per subject on the whole face.
~On V2 (M1), a possible touch-up can be made according to the injector and subject's opinion which cannot exceed 4 ml."
15834891|NCT04165460|Other|Cognitive Restructuring|Teaching the patient to identify dysfunctional cognitions about cancer and oncological treatment that trigger maladaptive emotions and behavior. Then, focus in generating alternative thoughts through contrast with empirical reality based on the Beck Model.
15834799|NCT04166279|Other|Single rehabilitative treatment|The rehabilitation treatment, performed by a physiotherapist trained in oncological rehabilitation, was carried out with a 6-week exercise program for 12 sessions (60 minutes/session, 2/week).). The protocol included a first phase consist in low impact aerobics warming (15-20 minutes), then diaphragmatic breathing and postural exercises for the midline alignment. The awareness of abdominal breathing represents the preliminary phase for a complete psychophysical relaxation of the patient, an important prerequisite for the correct execution of subsequent mobility, stretching and strengthening exercises of spine, scapula and upper limb. Subsequently, isometric strengthening exercises for shoulder stabilizing muscles, first passively and, subsequently, with supervision, were performed. Specific exercises, for passive mobilization and stabilization of the scapula, cervical pumping and stretching of the pectoral muscles, have been performed.
15834800|NCT04166279|Other|Group rehabilitative treatment|Four-five patients for group. The rehabilitation treatment, performed by a physiotherapist trained in oncological rehabilitation, was carried out with a 6-week exercise program for 12 sessions (60 minutes/session, 2/week). The protocol included at first week mainly breathing techniques, then we introduced exercises gradually more active, according to the improvements of the execution. The exercises had the aim to improve the opening of the scapular chain and to increase the amplitude of the range of motion in order to stimulate better neuromuscular control during the movement of scapular retropulsion, to stretch the pectoral muscles following the rhythm of the breath and the tissues affected by post-surgical scars and fibrotic effects, finally to reinforcing, against gravity, the musculature of the shoulders and back.
15834801|NCT04166253|Drug|Vitamin D|Alfacalcidol oral tablets once daily
15834802|NCT04166240|Behavioral|SAFER TRACKS Intervention|SAFER Change Package delivered using a Virtual Breakthrough Series [VBTS] Collaborative supplemented with automated surveillance data on test results.
15834803|NCT04166227|Procedure|Hip Arthroscopy|Patients in the Hip Arthroscopy group will undergo arthroscopy in the supine position under general anesthesia, with all procedures performed by two subspecialty-trained hip arthroscopists. An algorithmic surgical approach will be utilized to sequentially address pathology in the central and peripheral compartments of the hip based on both preoperative imaging findings and intraoperative findings. Emphasis will be placed on labral preservation and refixation, with osseous decompression under fluoroscopic guidance.
15834804|NCT04166227|Procedure|Total Hip Arthroplasty|Patients randomized to the Total Hip Replacement (THR) group will undergo THR via a direct anterior approach. A slightly oblique skin incision measuring approximately 8 cm will be used, starting 3 cm distally and laterally to the anterosuperior iliac spine. The intervals between tensor fascia lata (TFL) and sartorius will be developed superficially, and between rectus femoris and gluteus minimus deeper. Capsulotomy will be performed. A double osteotomy of the femoral neck will be performed to facilitate removal of the head followed by traditional preparation of the acetabulum using an offset reamer and the acetabular component will be inserted. Next, the superior capsule will be released to elevate the femur to allow access to the femoral canal, followed by standard preparation by use of an offset broach and the stem will be implanted
15834805|NCT04166214|Other|Imaging using intraoral cameras|The SOPROCARE is intended for clinical practice of general dentistry, as an aid in the diagnosis of pit and fissure caries, as an aid to highlight dental plaque and gingival inflammations and as intra-oral camera to visualize anatomical details that are invisible to the naked eye or with a mirror. In CARIO mode, the camera helps the dental practitioner to highlight carious warning on pits and fissures of the occlusal side of the teeth. In DAYLIGHT mode, the camera enables you to visualize anatomical details invisible to the naked eye or with a mirror. In PERIO mode, the camera helps the dental practitioner to see the presence of dental plaque but also to highlight gingival inflammations . This mode offers to the dentist and/or hygienist a tool for an improved communication, motivation and education of his/her patients, who will then become aware of their oral health condition.
15834806|NCT04166201|Procedure|double mesh hernioplasty with modified chevrel's technique|hernioplasty done by modification of the chevrel's technique , no dissection further than 1 cm of the midline laterally, the medial flaps of the anterior rectus sheath is dissected of the anterior surface of the rectus abdominis muscle and sutured together reforming the posterior rectus sheath , one polypropylene mesh was fixed over the posterior rectus sheath and the other was tailored to raw area of the rectis abdominis muscle and sutured to the lateral free edges of the anterior rectus sheath
15834807|NCT04166188|Procedure|Lumbar erector spinae plane block|Injection of blue solution in the erector spinae plane in L4 ultrasound-guided and posterior dissection of the lumbar region.
15834808|NCT04166175|Procedure|botox injection in intersphincteric space|injection of 80 IU of botox in the intersphincteric space in 5,7,11 and 1 O'clock position
15834809|NCT04166175|Procedure|lateral internal sphincterotomy|lateral internal sphincterotomy under GA in lithotomy position
15834810|NCT04166162|Behavioral|Brief Intervention Motivational Interviewing (BIMI) Intervention|BIMI is a 15-minute brief interview in person or via video chat with participating youth. The interview will be focused on discussing the impact of drinking alcohol on one's health and how to set personal goals so that alcohol use does not become a problem. A follow up phone or video call at 3 and 6 months post initial interview will also be conducted which will track on the progress of setting and keeping personal goals.
15834811|NCT04166162|Behavioral|Tomando Buenas Decisiones (TBD) Intervention|The program is adapted from the Guiding Good Choices (GGC) program and will be conducted by a trained facilitator lasting for about 2 hours per session. The program discusses about the best ways to help one's child make good decisions with regards to avoiding alcohol, drugs, and other problem behaviors that may not be healthy to them as well as ways to have good communication and good connections within one's family.
15834812|NCT04166162|Behavioral|Social Development Strategy (SDS) Intervention|SDS is a 2 hour broad-focused environmental intervention consisting of short presentations and workshops designed to provide skills and models for positive human interaction between employees to fellow employees, employees to their children and employees to their supervisors.
15834813|NCT04166162|Behavioral|BTC Training Session|BTC training session consists of trainings, discussions and tools focused on community mobilization for the assessment and implementation of evidence-informed preventive interventions addressing community health and behavior problems. Each training session lasts about 4 hours.
15834892|NCT04165460|Other|Solving Problems|To generate alternative solutions to practical problems based on the model described by Nezu.
15834814|NCT04166149|Diagnostic Test|dd-cfDNA Blood Test|The cfDNA measurement isolated from the peripheral blood contains small amounts from the graft. The blood sample is collected in Cell-Free DNA BCT (blood collection) tubes. These are measured by their difference in SNP (single nucleotide polymorphisms) genotype to determine the ratio of donor to recipient through shotgun sequencing. Higher levels of dd-cfDNA in a patient experiencing rejection is measured as a higher percentage of the total cf-DNA.
15834815|NCT04166136|Other|Transition from the Rearfoot to the Forefoot and Midfoot|Participants in this group will perform a training aimed at the transition of foot strike pattern from the rearfoot to the forefoot and midfoot progressively. Initially a ten-minute race will be held at a comfortable warm-up speed. Then the participants in this group will run continuously at the usual treadmill speed for thirty minutes in a 12-week progressive training program. Participants will run shod and barefoot alternately. Each week the barefoot running time increased to 30 minutes.
15834816|NCT04166136|Other|Usual Treatment Group|This group will perform standard physiotherapeutic treatment performed at the Naval School. This treatment consists of the application of conventional TENS whose parameters are: alternating current, rectangular pulse, pulse duration 100μs, frequency of 100Hz for 12000 seconds. Laser therapy with an energy of 5 J at each point, irradiation area of 1cm², irradiation time of 20 seconds, 30 repetitions and total time of 6000 seconds.
15834817|NCT04166136|Other|Muscle Strengthening Group|The participants of this group will perform muscle strengthening exercises for trunk and lower limbs divided into four phases of three weeks each. The total period of the program strength will be 12 weeks. Elastos® elastic bands of weak, medium and strong intensity will be used to provide progression to the exercises. The exercises will be supervised and supervised by two physiotherapists. A Phase 1 will consist of four exercises; a phase 2, phase 3 and phase 4 will consist of five different exercises each one. In addition to the muscle strengthening le strengthening protocol, this group will have free access to the standard physiotherapeutic treatment performed at the Naval School during and after the study.
15834818|NCT04166110|Drug|Predetermined treatment duration|Antibiotic treatment duration left to the physician's judgement (following national guidelines, 7 to 14 days)
15834819|NCT04166110|Drug|Variable treatment duration|"Treatment duration vary according to stability criteria reaching time Patients will self-monitor 2 times a day (in the morning and in the evening) using a set of connected devices, to monitor their vital signs before any treatment intake.
~After at least 3 days of treatment and stability criteria obtained for the last 24 hours (i.e. 3 vital signs recording), patients will stop the antibiotic treatment."
15834820|NCT04166097|Other|Heart Smart Interventional Program|6-week program consisting of weekly didactic sessions that follow the steps outlined in the book.
15834821|NCT04166084|Other|Active ROM Exercises|Active ROM exercises programme will include hip flexion-extention, hip abduction-adduction, hip internal-external rotation, knee flexion-extention and ankle dorsi-plantar flextion exercises.
15834822|NCT04166084|Other|Trunk Stabilization Exercises Training|Trunk stabilization exercises training will be given under the supervision of a physiotherapist. This training exercises will include diphragmatic exrecises, posterior pelvic tilt exercises, abdominal streghtening exercises,
15834823|NCT04166071|Drug|Naltrexone|Half of the participants will be randomly assigned to take one dose of naltrexone (50mg, capsule form) during the experimental session
15834824|NCT04166071|Drug|Placebo|Half of the participants will be randomly assigned to take a placebo capsule during the experimental session
15834825|NCT04166058|Drug|Irritable Bowel Syndrome with Constipation (IBS-C) participants (LIN-MD-63 completers)|Participants whom are between the ages of 7-11 years old at their time of enrollment will be assigned a dose (72 μg or 145 μg) based on their weight. Randomized doses (145 μg or 290 μg) will be assigned to participants whom are 12-17 years old at the time of enrollment.
15834826|NCT04166058|Drug|Functional Constipation (FC) participants (LIN-MD-62 and LIN-MD-64 completers)|Participants whom are between the ages of 6-11 years old at their time of enrollment will be assigned a dose of 72 μg. Randomized doses (72 μg or 145 μg) will be assigned to participants whom are 12-17 years old at the time of enrollment.
15834827|NCT04166045|Device|Sham Treatment Location|The device applies transcutaneous electrical nerve stimulation to the bicep
15834828|NCT04166045|Device|Verum Treatment Location|The device applies transcutaneous electrical nerve stimulation to the hand
15834832|NCT04166006|Biological|Autologous DC vaccine|7-14×106 autologous dendritic cells loaded with autologous tumour homogenate given by intradermal injection (day 1)
15834833|NCT04166006|Drug|Interleukin-2|Autologous DC vaccine is followed by IL-2, at a dose of 3 MU, given by subcutaneous injection daily for five days (days 3-7).
15834834|NCT04165993|Drug|Concurrent chemotherapy and KN026|30 mg/kg Q3W KN026 75 mg/m2 docetaxol
15834835|NCT04165993|Drug|KN026 monotherapy|30 mg/kg Q3W KN026
15834836|NCT04165993|Drug|KN026 combination|30 mg/kg Q3W KN026 5 mg/kg Q3W KN046
15834837|NCT04165980|Device|transcranial direct current stimulation|Transcranial direct current stimulation delivers a low intensity current of up to 4 mA per session through small and circular shaped electrodes applied over the scalp. This induces a weak but focal electrical field that may modify the excitability of the underlying cortical target in a polarity and activity dependent fashion.
15834957|NCT04165057|Other|Optimal muscle tension management|including TOF monitor and reversal of neuromuscular blockade agent : sugammadex
15834838|NCT04165967|Drug|Combination of TIL Transfer with anti-PD-1 Therapy and low dose IL-2|"The study uses a personalized IMP, i.e. TIL product and in combination with IL-2 treatment and nivolumab.
~Day 0: Autologous TIL: (minimum 5 x 109 and up to a maximum of 2 x 1011 lymphocytes) administered intravenously over 20 to 30 minutes.
~Day 0: Interleukin-2 (Proleukin): 125.000 IU/kg/day s.c. for maximum 12 days as inpatients with a 2 days break after the first 4-5 doses (maximum 10 days dosing). Actual body weight will be used in calculating the dose of interleukin-2.
~Starting Day 14: Nivolumab application 240 mg i.v. over 30 minutes ever 2 weeks with a maximum to 2 years, or until disease progression or inacceptable toxicity."
15834839|NCT04165941|Biological|DRI cell therapy|Drug Resistant Immunotherapy with gamma delta modified T cells to be resistance to temozolomide will be infused into the surgical cavity following the completion of standard concurrent radiation and chemotherapy with temozolomide.
15834840|NCT04165902|Drug|compare the effects of steroid plus hyaluronic acid and destrose plus hyaluronic acid on knee osteroarthritis|compare the immediate effect (one week after 3 times of injections), short-term effects (one month and three months after 3 times of injections), and midterm effect (6 months after 3 times of injections).
15834841|NCT04165876|Device|Primary Motor Cortex Stimulation|Using the Starstim 32, HD-tDCS equipment we provide 20 minutes of 2 mA anodal stimulation of primary motor cortex (M1) using a ring-cathode configuration
15834842|NCT04165876|Device|Dorsolateral Prefrontal Cortex Stimulation|Using the Starstim 32, HD-tDCS equipment we provide 20 minutes of 2 mA anodal stimulation of dorsolateral prefrontal cortex (DLPFC) using a ring-cathode configuration
15834843|NCT04165876|Device|Multimodal Stimulation (DLPFC+M1)|Using the Starstim 32, HD-tDCS equipment we provide 20 minutes of 2 mA anodal multimodal stimulation of dorsolateral prefrontal cortex (DLPFC) and primary motor cortex simultaneously using ring-cathode configurations around the two anodes.
15834844|NCT04165876|Device|Sham stimulation|Using the Starstim 32, HD-tDCS equipment we provide sham stimulation with 30 seconds of ramping up to 2 mA intensity, then turning off for 19 minutes and then ramping down from 2 mA intensity to 0 in the last 30 seconds.
15834845|NCT04165863|Procedure|total knee replacement surgery|total knee replacement surgery
15834846|NCT04165850|Drug|Fixed dose combination Ciprofloxacin/Celecoxib|Fixed dose Ciprofloxacin and Celecoxib capsule to be taken thrice daily, total dose 909mg/day
15834847|NCT04165837|Drug|FB-101|Part A - Single Ascending Dose study Part B - Multiple Ascending Dose study
15834848|NCT04165837|Drug|Placebo|Part A - Single Ascending Dose matching placebo study Part B - Multiple Ascending Dose matching placebo study
15834849|NCT04165824|Drug|MT-1186|"An initial treatment cycle with daily dosing for 14 days, followed by a 14-day drug free period
~Subsequent treatment cycles with daily dosing for 10 days out of a 14-day period, followed by a 14 day drug free period. Treatment cycles are every 4 weeks."
15834850|NCT04165811|Other|Exercise treatment|A program consisting of aerobic dance based exercises and physical activity counseling accompanied by physiotherapists will be applied to the study group.
15834851|NCT04165811|Other|Counselling|Only physical activity counseling will be given to the subjects in this group.
15834855|NCT04165785|Device|OPT IPL|Intense pulsed light (IPL) is a non-invasive and non-laser light treatment that is FDA-approved for various conditions in dermatology. Subjects will receive a total of 4 IPL treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications of 24 IPL pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression.
15834856|NCT04165785|Device|Sham OPT IPL|Sham Optimal pulsed technology intense pulsed light IPL will be implemented with an IPL device in which all light is blocked by a filter. Subjects will receive a total of 4 sham treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications of 24 sham pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression.
15834857|NCT04165785|Procedure|MGX|Meibomian gland expression (MGX) will be implemented by squeezing the meibomian glands with the aid of stainless steel jaeger lid plate positioned in the inferior fornix space between the tarsal and bulbar conjunctiva, and a cotton swab in another side.
15834858|NCT04165772|Drug|TSR-042|Patients will be given TSR-042 at a dose of 500mg IV, over 30 minutes Q 3 weeks.
15834859|NCT04165772|Drug|capecitabine or 5-FU|Capecitabine 825mg/m2 BID concurrently with radiation per standard radiation guidelines. If patient is unable to tolerate oral medication, infusional 5-FU is an acceptable alternative.
15834860|NCT04165772|Radiation|Intensity Modulated Radiation Therapy (IMRT)|The radiation dose is 5400 cGy to the tumor and surrounding nodes 4700 cGy to the pelvis, with an integrated boost to the primary tumor and involved nodes of receiving 5400cGy in 27fx.
15834861|NCT04165746|Other|Foster Care|"Upon entry into the Child Protection System, if the child is assigned to one of the districts participating in the RCT, the court will notify the study team. Children that have been randomly assigned to Foster Care will be placed in a foster home within 48 hours of referral to the Family Court/Child Protection System.
~Children and Foster Parents will receive biweekly visits from Social Workers. Children and Foster parents will also participate in the caregiving intervention described below. Children will remain in the placement until such time as the social workers, psychologists and Family Court Judge determine that one of the following outcomes is appropriate: reunification with biological family or adoption."
15834893|NCT04165447|Behavioral|Front-of-pack labeling strategy|We designed a simple 'Lower Calorie' directive logo. We labeled the 20% of products with the lowest calories per serving within or across categories. All serving sizes used in this study were the average of the serving sizes within each category. Prior to conducting the analysis, we standardized the serving size by using the mean serving size within each subcategory. This standardization ensures that similar products are compared equally as serving sizes can be arbitrarily set by the manufacturers. The labels were displayed below the product images.
15834894|NCT04165434|Other|Concurrent Training|Strength training and interval aerobic training in the same training session
15834862|NCT04165746|Behavioral|Caregiving Intervention|During VIPP an intervenor meets with a caregiver (foster parent or caregiver at the institution) and child in the home environment. During each session, the intervenor videotapes the caregiver and child doing play-based activities. After the meeting, the intervenor reviews the videos. At the next meeting, the intervenor reviews the videos with the caregiver and provides positive, constructive feedback to the caregiver. VIPP is aimed at increasing sensitivity in parents/caregivers in order to encourage positive interactions. The guiding principles are to create a positive environment and to convey that the caregiver is the expert on their own child. VIPP has been used as an intervention in traditional families, childcare settings, foster care, and for families with children with autism. VIPP has demonstrated its effectiveness through 12 RCTs in several different countries. This will be the first time that VIPP is being used in foster and institutional care in Brazil.
15834863|NCT04165733|Diagnostic Test|Online questionnaire|Clinical psychologists in Germany currently working with patients with mental disorders
15834864|NCT04165720|Diagnostic Test|Online questionnaire|Online questionnaire via SoSciSurvey
15834865|NCT04165707|Device|Keyto device + app|Keyto is a self-monitoring and app-enhanced intervention to help individuals learn about and monitor their breath acetone (a measure of ketosis) levels to promote a very low carbohydrate diet and weight loss.
15834866|NCT04165707|Other|Weight Watchers app|The Weight Watchers app helps people to monitor their food intake, track points and provides recipe ideas to support weight loss.
15834867|NCT04165694|Procedure|Single Anastomosis Duodenal Ileal Bypass (SADI)|The purpose of the research is to study additional weight loss and resolution of comorbidities in patients who undergo revision of their sleeve gastrectomy to a Single Anastomosis Duodenal Ileal bypass (SADI). The sleeve gastrectomy which you have already undergone is now the most common bariatric procedure performed. This operation was part of a 2-stage operation known a Duodenal Switch (DS) which was a sleeve gastrectomy followed by a long bypass of the intestine that involved 2 connections. This operation has many complications such as vitamin deficiencies and potential malnutrition. The SADI procedure is a version of the DS that bypasses less of the intestine and one less connection of the small bowel.
15834868|NCT04165681|Other|Limbix Spark|5-week, self-guided mobile + VR CBT-based program for adolescent depression
15834869|NCT04165668|Other|Exposure: First on scene|To be first on scene for resuscitation at the suspected out-of hospital cardiac arrest, before EMS and first responders (fire and police services)
15834870|NCT04165655|Behavioral|Keep Achieving (KA)|The 10-week group based activity programme will consist of 10 sessions each lasting 50 minutes.
15834871|NCT04165642|Other|Laser ballon ablation for Pulmonary vein isolation|The patients indicated to AF ablation procedure will be treated with laser balloon ablation without verification of electrical isolation of pulmonary veins using implantable loop recorder and/or Holter monitoring
15834872|NCT04165629|Drug|Aspirin 300mg and Clopidogrel 300mg|Aspirin 300mg and Clopidogrel 300mg on the day of the PTA
15834873|NCT04165603|Procedure|Preoperative Infusion of Indocyanine Green|preoperatively infuse indocyanine green through peripheral vein
15834874|NCT04165590|Other|Plasmodium immunotherapy|The patient will be vaccinated with P. vivax-infected red blood cells containing approximately 0.1-1.0 × 10^7 Plasmodium parasites.
15834875|NCT04165577|Device|rTMS|1-Hz rTMS targeting frontal pole
15834876|NCT04165577|Device|sham rTMS|sham rTMS targeting frontal pole
15834877|NCT04165564|Other|Institutional standard of care|Institutional standard of care may involve the use of LungRADS (screening setting) or Fleischner criteria (either combined 2005, 2013 or 2017 guidelines)
15834878|NCT04165564|Other|Biosamples of airway and blood|Identify biomarkers in biosamples from airway and blood for the preclinical detection of lung cancer.
15834879|NCT04165551|Biological|Probiotic|Volunteers will take 1 capsule a day of the Probiotic during lunch without any restrictions on diet or lifestyle.
15834880|NCT04165551|Biological|Placebo|Volunteers will take 1 capsule a day of the Placebo during lunch without any restrictions on diet or lifestyle.
15834881|NCT04165538|Procedure|Thrombelastograph and surgical timing|Patients in the TEG group will undergo a Thrombelastograph test after admission, and the timing of operation will be determined according to the results of the test, that is, 1 day, 3 days and 5 days later respectively for patients with ADP-induced platelet-fibrin clot strength (MAADP) of > 50 mm, 30-50 mm and < 30 mm. For Non-TEG patients, the drug withdrawal time is determined by the doctor in charge according to the clinical routine, generally about one week.
15834882|NCT04165525|Device|Ablation|comparison of using an argon gas and high frequency electrical current ablation device with a standard Bovie electrosugical device without argon gas.
15834883|NCT04165512|Combination Product|bupivacaine and triamcinolone|a mixture of 4 mL 0.5% bupivacaine (marcaine) and 1 mL 40 mg triamcinolone (kenacort-a)
15834884|NCT04165499|Combination Product|Combination of Plant Extracts (BSL_EP026)|Each participant will consume 2 capsules daily, in the morning and in the evening.
15834885|NCT04165499|Combination Product|Control|Each participant will consume 2 capsules daily, in the morning and in the evening.
15834886|NCT04165486|Drug|BIIB101|Administered as specified in the treatment arm.
15834887|NCT04165486|Drug|Placebo|Administered as specified in the treatment arm.
15834888|NCT04165473|Behavioral|Training Program for Developing Social- and Personal Resources|"The training-method shows how one's own resonance can be exposed in order to live the balance between one's own needs and those of others.
~Living one's own resonance means: more quality of life, work-life balance, holistic health through living feelings and talents, live equal, respectful and loving relationships, more personal responsibility, authentic decision making find new role models in private and professional areas.
~The teaching and learning methods of the trainings and seminars are implemented according to the latest state of brain research and enable new perspectives with regard to new learning strategies, goals, enthusiasm and motivation.
~With the Kutschera-Resonanz® method we teach and learn to consciously use this unconscious reservoir so that completely new dimensions in thinking and acting open up.
~In this training program the basic tools of communication and interaction according to the Kutschera-Resonanz® method are taught and experienced by the participants."
15834889|NCT04165460|Other|Psychoeducation|Delivering systematic information about cancer, oncological treatment and efficient coping strategies.
15834890|NCT04165460|Other|Relaxation|Teaching the patient in diaphragmatic breathing retraining and passive relaxation with guided imagination.
15834896|NCT04165408|Device|Contino|The Contino® urethral insert is a self-administered licensed medical device, is inserted into the distal portion of the male urethra inhibiting the flow of urine. The Contino is self-inserted into the adult male urethra and is removed prior to urination. Much more than just a device, Contino® is an integrated solution that includes personalised fitting and support from incontinence specialists. It is made from highly specialised medical grade polymer, which has been extensively tested for biocompatibility.
15834897|NCT04165395|Device|Five-layer foam dressing|Five-layer foam dressing applied on the sacrum within 48 hours of spinal surgery
15834898|NCT04165395|Device|Heelmedix boot|Heelmedix boot will be installed alternately from one foot to the other.
15834899|NCT04165382|Other|Interventions in the guideline to infants receiving NIV|"Interventions in the guideline involve six components as
~choice of right nasal interfaces and bonnet
~use of skin protective dressing
~alternate the nasal interfaces every 6 hours;
~positioning the infants at optimal developmental body position without prone every 4-6 hours, and well supporting the devices to prevent displacement and traction
~supportive care with more new interventions
~regular assessments on infants receiving NIV for pain level and skin integrity for the areas in contacting with the nasal interfaces and devices of NIV"
15834900|NCT04165382|Other|Usual care to infants receiving NIV|Usual care includes the choice of nasal interface for NIV; use of skin protective dressing; positioning of infants without specific frequency or types of position; supportive care as to provide humidification to the ventilator circuit, to remove water condensate in the ventilator circuit, to provide oral care every 3-4 hours and avoid unnecessary nasal suctioning.
15834901|NCT04165356|Procedure|Mouth-rinse with 0.12% clorhexidine|mouthwash with 0.12% chlorhexidine twice daily compared to isotonic bicarbonated solution twice daily for the prevention of any infection associated with mechanical ventilation in patients requiring endotracheal intubation in the intensive care unit of a third level hospital.
15834902|NCT04165356|Procedure|Mouth-rinse with isotonic solution with 1.5% sodium bicarbonate|mouthwash with sotonic solution with 1.5% sodium bicarbonate twice daily for the prevention of any intection associated with mechanical ventilation
15834903|NCT04165343|Radiation|Positron Emission Tomography (PET) on EXPLORER|"Positron Emission Tomography (PET): Your blood sugar level will be checked by a finger stick before the PET scan. A small amount of radioactive tracer (approximately 0.5 teaspoons) will be injected into a vein in your arm before the imaging test. You will be asked to lay on your back on the EXPLORER scanner platform with both of your arms over the head during the duration of the test. A small amount of blood (1 tablespoon) will be collected after the test. This test will last for up to one (1) hour. This is a research test. Although the results may be available it cannot be used for clinical care. If any incidental findings are noted, it will be reported to you."
15834904|NCT04165343|Diagnostic Test|Magnetic Resonance Imaging|MRI will be performed that can measure both the liver stiffness or fibrosis by a method called MR elastography (MRE) and the amount of fat deposited in the liver by MR proton density fat fraction (MR-PDFF). You will be asked to lay on your back on the scanner platform with both of your arms over the head during the duration of the test. MRE and MRI-PDFF are Food and Drugs Administration (FDA) approved tests and the results will be available to you. This test will last up to one (1) hour.
15834905|NCT04165343|Diagnostic Test|Echocardiogram and Electrocardiogram|You will have baseline echocardiogram images and electrocardiogram (ECG) taken and will be asked to walk on a treadmill, which will increase in elevation and speed every 3 minutes until you can go no longer. This usually takes 9 to 12 minutes. Immediately after exercise, echocardiogram images and ECG will be taken again. The total time you will be in the stress lab including prep time and recovery is about 60 minutes. Wear comfortable or exercise clothing and walking/running shoes. You will be asked to not eat or drink (except for water) for 4 hours prior to the time of your test. Please drink water the day of the test so you are not dehydrated. This is an FDA approved test and the results will be available to you.
15834906|NCT04165343|Diagnostic Test|Blood test|We will order laboratory blood tests as part of this research study and up to 3 tablespoons of blood will be collected for routine clinical and other laboratory tests relevant to the study. If you are able to become pregnant, you will have a urine pregnancy test before you begin the study.
15834907|NCT04165330|Drug|AL3818|"AL3818: Part 1 - 12 mg, 10 mg, 8 mg, or 6 mg (by dosing cohort), Part 2 - RP2D (as determined from Part 1).
~Administered orally once daily on Days 1-14 per 21 day Cycle."
15834908|NCT04165330|Drug|Nivolumab Injection|Nivolumab 240 mg Administered by injection every 2 weeks (Odd Cycles: Days 1 and 15 and Even Cycles Day 8) per 21 day Cycle.
15834909|NCT04165317|Drug|PF-06801591|A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PD-L1/PD-L2.
15834910|NCT04165317|Drug|Bacillus Calmette-Guerin|Immunotherapy treatment approved by FDA for patients with high-risk non-muscle invasive bladder cancer
15834911|NCT04165304|Dietary Supplement|sugar reduction|sugar reduction in the offered drinks
15834912|NCT04165291|Behavioral|F4C|Fathers for Change (F4C) focuses on: 1) the fathering role to facilitate engagement, 2) RF to understand self, partner and children and emotion regulation skills to reduce IPV and child maltreatment. F4C focuses on understanding of emotional experiences, how they impact thinking and behaviors related to partners, co-parents and children. F4C clients will meet individually with their F4C therapist for 50 minutes per week over 16 weeks.
15834913|NCT04165291|Behavioral|BIP|The Batterer Intervention Program (BIP) is a psychoeducational intervention that will be delivered in 50- minute individual weekly sessions over 16 weeks. The intervention focuses on the impact of violence on victims, power and control tactics, and societal influences supporting men's violence toward women. The intervention includes didactics and experiential exercises including role plays to teach anger management skills.
15834914|NCT04165278|Other|hyperthermic baths|Taking hyperthermic baths
15834915|NCT04165265|Device|Constant-Care|"Constant-Care (CC) (https://ibd.constant-care.com) is a web-application and contains an education and a disease monitoring package. An algorithm is established in the disease monitoring package, which consist of two variables; fecal calprotectin (FC) and a disease activity questionnaire (validated), Simple Clinical Colitis Activity index (SCCAI) for UC. The FC is obtained through CalproSmart app (it only takes 18 min) and the questionnaire is filled out in CC. Afterwards, the data are analyzed by CC and presented in a Total Inflammatory Burden Score (TIBS) as well as a visual traffic light of disease for the patients"
15834916|NCT04165252|Diagnostic Test|Collection of vaginal, neonatal buccal and placental samples|Analysis of microbiome and mycobiota of vaginal, neonatal buccal and placental
15834920|NCT04165226|Device|Low level light therapy|Patients will be offered 8 sessions of photobiomodulation using HPL Pagani Diode 808/915nm LLLT 3.2W (Fimad Elettromedicali SRL®, Catanzaro, Italy) with the parameters adjusted individually according to the surface area to be treated. Optimum dose is 10 joules/cubic centimeters. The patients will take 2 to3 sessions / week.
15834921|NCT04165226|Device|Fractional CO2|"Patients will be offered 2 sessions of fractional carbon dioxide laser on a 4 weeks interval. Topical anesthesia with pridocaine cream will be applied under occlusion for 30 - 60 minutes before the session.
~Please update to the proper apparatus and parameters DEXA SmartXide DOT Fractional CO2 laser system 10600 nm (DEKA®, Florence, Italy) will be used with the following parameters adjusted individually to patients': power of 15-20 W, dwell time of 500-800 μs, spacing of 200-500 μm, and stack 2."
15834922|NCT04165226|Device|Combined fractional CO2 laser and low level light therapy|Combined treatment of both modalities (fractionational CO2 laser and low level light therapy). Please describe more....
15834923|NCT04165213|Behavioral|COPE online training|"The intervention being tested is PACE staff training in COPE - accomplished with the creation of self-paced online learning modules.
~The modules will include rich multimedia content and interactive assessments to keep the learner engaged and will allow for easy packaging of the content into the latest interoperability standards for such content including the latest Shareable Content Object Reference Model (SCORM) specifications, which will allow for repurposing and sharing with other institutions and will be designed using a hyperlearning model with four dimensions. The self-paced modules will be highly interactive featuring integrated multimedia content, assessments, and learner evaluations to allow PACE staff to engage with the content at a high level and practice application in simulated scenarios. Each module will require approximately 45-60 minutes/module for the learner to complete.le for the learner to complete."
15834924|NCT04165200|Diagnostic Test|Blood and feces samples|"Blood samples are going to be taken by puncturing peripheral vein extraction with 10 ml of venous blood for later biweekly to monitor in person and therefore monitor immune status with biomarkers T lymphocyte subclass CD4 and viral load. A total of four blood samples will be taken at weeks 4, 8, 12 and 24 of recruitment.
~A total of four feces samples are going to be required during the study, to evaluate the changes on the microbiota of the patient. 1 week before the patients start their HAART, the same day the patients initiate their HAART, 8 weeks after they started HAART and 24 weeks after HAART."
15834925|NCT04165187|Other|Body Awareness Therapy|Body scanning, stretch-release movements, centralization, contact with the ground, postural stability, movement flow and free breathing will be performed during sessions in lying, sitting and standing positions.
15834926|NCT04165187|Other|Home exercise program|Home exercise program will consist of joint range of motion, stretching, strengthening and proprioceptive exercises for lower extremity.
15834927|NCT04165174|Drug|Terepril monoclonal antibody; Apatinib|Terepril monoclonal antibody,240mg,ivdrip,Q3W Apatinib,250mg,po,QD
15834928|NCT04165174|Radiation|SBRT|6-10Gy/F,5-8F
15834929|NCT04165161|Diagnostic Test|search for a patent foramen ovale|Injection of a contrast solution A - In the upper cellar territory with controlled ventilation without positive tele-expiratory pressure; B - In the upper cellar territory in controlled ventilation with a positive end-to-expiratory pressure of 10cm H2O; C - In the lower cellar territory with controlled ventilation without positive tele-expiratory pressure; D - In the lower cellar territory in controlled ventilation with a positive end-to-expiratory pressure of 10cm H2O;
15834930|NCT04165148|Device|Low Impact Laparoscopy|Low Impact Laparoscopy is a minimally invasive technique that combines low pressure insufflation (with the iFS AirSeal® system) and microcoelioscopy (with specific microtrocards and laparoscopic instruments).
15834931|NCT04165148|Device|conventional laparoscopy|conventional laparoscopy
15834932|NCT04165148|Other|Visual Analog Scale (VAS) for Pain|"The patient evaluates her pain using an VAS scale on arrival in the post-interventional surveillance room, then 30 minutes, 2 hours, 4 hours, 6 hours after leaving the operating roo, at the exit of post-interventional surveillance room and at the exit of the hospital.
~The day after surgery, according to the usual practice, outpatients receive a telephone call from a Gynecologist. The assessment of their pain (with VAS scale) will be collected.
~During the usual consultation at 1 month, the patient must evaluate her pain by means of an VAS."
15834933|NCT04165148|Other|Saint-Antoine Pain Questionnaire (QDSA)|"The patient evaluates her pain using an QDSA questionnaire on arrival in the post-interventional surveillance room, then 30 minutes, 2 hours, 4 hours, 6 hours after leaving the operating roo, at the exit of post-interventional surveillance room and at the exit of the hospital.
~The day after surgery, according to the usual practice, outpatients receive a telephone call from a Gynecologist. The assessment of their pain (with QDSA questionnaire) will be collected.
~During the usual consultation at 1 month, the patient must evaluate her pain by means of an QDSA questionnaire."
15834934|NCT04165148|Other|post-operative questionnaire|The patient will fill in the antalgic intake record and the patient booklet for the collection of medical consumptions from her discharge from the hospital and during the month following the surgery.
15834935|NCT04165135|Drug|Standard of Care for Haemophilia A|There is no pre-determined studied medicinal product. Any treatment (including treatments started during the observational period) will be administered according to standard clinical practice, independently of participation in the current study, according to clinician's independent therapeutic decision.
15834936|NCT04165122|Biological|HDIT101|i.v. Infusion
15834937|NCT04165122|Drug|Valaciclovir|oral application of encapsulated Valaciclovir tablets
15834938|NCT04165122|Biological|HDIT101 placebo|i.v. Infusion
15834939|NCT04165122|Drug|Valaciclovir placebo|oral application of encapsulated Valaciclovir placebo tablets
15834940|NCT04165109|Radiation|Flutafuranol|All participants at qualifying sites will receive a single bolus intravenous injection of 8.1 mCi (300 MBq) (+/- 20%, 10μg mass dose) of flutafuranol ([18F]NAV4694). At approximately 90-minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.
15834941|NCT04165109|Radiation|Pittsburgh Compound (PIB)|All participants at qualifying sites will receive a single bolus intravenous injection of 15 mCi (555 MBq) (± 10%) of PIB. At approximately 30-minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.
15834942|NCT04165109|Radiation|MK6240|All participants at qualifying sites will receive a single bolus intravenous injection of 5 mCi (185 MBq) (± 20%) of MK6240. At approximately 90-minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.
15834958|NCT04165044|Procedure|Leukocyte and Platelet Rich Fibrin plus Coronally Advanced Flap|The Coronally advanced flap was made following the protocol described by Zucchelli et al. in 2007. (39). When the margin of the flap was able to passively extend until more coronal of the CEJ the coronal mobilization of the flap was considered satisfactory. A double L-PRF membrane was positioned at the level of CEJ, getting the stabilization with 5-0 resorbable suture. After that, the flap was coronally advanced and stabilized with interrupted sutures (5-0 resorbable) anchored to incisal contact points (mesial and distal) created with a flowable, light-curing resin material in the treated tooth. Finally, gentle pressure over the area with a moistened gauze with saline solution was performed.
15834959|NCT04165044|Procedure|Connective tissue graft plus Coronally Advanced Flap|The Coronally advanced flap was made following the protocol described by Zucchelli et al. in 2007. (39). When the margin of the flap was able to passively extend until more coronal of the CEJ the coronal mobilization of the flap was considered satisfactory. Then connective tissue graft obtained from the palate was positioned at the level of CEJ, getting the stabilization with 5-0 resorbable suture. After that, the flap was coronally advanced and stabilized with interrupted sutures (5-0 resorbable) anchored to incisal contact points (mesial and distal) created with a flowable, light-curing resin material in the treated tooth. Finally, gentle pressure over the area with a moistened gauze with saline solution was performed.
15834960|NCT04165031|Drug|LY3499446|Administered orally
15834961|NCT04165031|Drug|Abemaciclib|Administered orally
15834962|NCT04165031|Drug|Cetuximab|Administered IV
15834963|NCT04165031|Drug|Erlotinib|Administered orally
15834964|NCT04165031|Drug|Docetaxel|Administered IV
15834965|NCT04165018|Procedure|Fine-Needle Biopsy (FNB)|Fine-needle biopsy may be used to take samples of a pancreatic neoplasm.
15834966|NCT04165005|Behavioral|decentering|examined a mindfulness-based intervention focused on a decentering component, that is suitable for elders, aimed to influence on cognitive measures and psychological distress.
15834967|NCT04165005|Behavioral|guided imagery|relaxing guided imagery including breathing exercises.
15834968|NCT04164992|Device|EUSRA electrode needle connected to a radiofrequency generator (VIVA RF generator; STARmed, Seoul, S. Korea)|The operative needle (EUSRA-STARMED) is a novel monopolar 18 gauge radiofrequency ablation (RFA) electrode that is placed in the echoendoscope operative channel. It is 140 cm long with a sharp conical 1 cm tip for energy delivery. The needle is associated with an internal cooling system connected via a pump to an external cold saline solution source (0 °C) that prevents the charring of the tip and improves the ablation accuracy.
15834969|NCT04164979|Drug|Cabozantinib|Given PO
15834970|NCT04164979|Drug|Pembrolizumab|Given IV
15834971|NCT04164953|Procedure|Surgical treatment|Surgical treatment of Dupuytren's disease. Average from 2 to 4 joints per hand operated on simultaneously
15834972|NCT04164940|Other|Brief alcohol intervention|Brief alcohol intervention already implemented in daily routine by the individual hospitals.
15834973|NCT04164927|Other|Manual Lymphatic Drainage|"Lymphatic correction method was used via the KinesioTaping® to patients group.
~Standardized 30-minute Manuel Lymphatic Drainage treatment was applied to the MLD group.
~Control group received only physiotherapy treatment."
15834974|NCT04164927|Other|Kinesio Taping|Depending on the size of the leg two or three fan cut tapes were applied with light paper-off tension on the frontal, medial and lateral aspects of the limb. Kinesio taping was applied by certified Kinesio Tape practitioner once a week to Kinesiotaping group.
15834975|NCT04164927|Other|Control|Knee-based exercises were undertaken in supine (active- assisted knee flexion using a bandage, inner range quadriceps contractions, and straight-leg raises), seated (active-assisted knee flexion using the contralateral limb and inner range quadriceps contractions), and standing (hip and knee flexion, active hamstring curls, lunges on a step, hamstring stretches) postures. These exercises were undertaken in sets of 10 repetitions, 3 times daily; the physiotherapist was present to assist, as required, on 2 occasions per day for the first 3 postoperative days and then once daily from day 4 until hospital discharge.
15834976|NCT04164914|Dietary Supplement|Prebiotic|Soluble prebiotic fiber (resistant dextrin 14 g/d x 4 weeks)
15834977|NCT04164901|Drug|Vorasidenib|Vorasidenib oral film-coated tablets
15834978|NCT04164901|Drug|Matching Placebo|Matching Placebo oral tablets
15834979|NCT04164888|Drug|CIVI 007|hypercholesterolemia agent
15834980|NCT04164875|Diagnostic Test|Temperature measurement|The 'intervention' is repeated rectal temperature measurements
15834981|NCT04164862|Device|AccuVein AV400 Device Versus Ultrasound-guided Cannulation|Accuvein AV400 device versus Ultrasound guided cannulation
15834982|NCT04164849|Drug|5-aminolevulinic acid|5-aminolevulinic acid (30 mg/ml) will be added to mononuclear cells in a dose of 3 millimolar and incubated for 1 hour
15834983|NCT04164849|Procedure|Blue light photopheresis|The mononuclear cells incubated with 5-aminolevulinic acid for 1 hour will be exposed to blue light.
15834984|NCT04164849|Procedure|Transfusion|The treated cells are transferred back to the patient as a standard blood transfusion
15834985|NCT04164849|Procedure|Continuous Mononuclear Cell Collection (CMNC)|The mononuclear cells are collected using the Spectra Optia with the Continuous Mononuclear Cell Collection protocol. 90 ml of mononuclear cells will be collected and 100 ml of 0,9% saline will be added to dilute the cells before incubation with drug and photopheresis.
15834986|NCT04164849|Procedure|Red light photopheresis|The mononuclear cells incubated with 5-aminolevulinic acid for 1 hour will be exposed to red light.
15834987|NCT04164836|Diagnostic Test|rhinoscope|more suitable nose for nasotracheal intubation will be selected based on the view of rhinoscope.
15834988|NCT04164823|Device|Medical taping|For the medical taping group, a piece of Kinesio tape 5 cm in width and 7-8 cm in length will be applied right from below the navel and will reach to where the pubic hair begins, and another piece of tape 10 cm in length will be applied to make a cross shape with the first piece. A tape of 20cm in length will be placed horizontally to the lower back.
15834989|NCT04164823|Drug|Analgesic self-medication (OTC)|Participants will note the usual analgesic self-medication used to relief pain (ibuprofen, acetaminophen...).
15834990|NCT04164810|Other|Hydrotherapy|All sessions will be done by 3 physical therapists specialized in hydrotherapy under different modalities, and a pool equipped to perform this type of intervention. The most commonly used techniques in the institution are Bad Ragaz, for motor control, and the Watsu technique for relaxation and spasticity work.
15834991|NCT04164810|Other|Physical Therapy|All sessions will be done by 3 physical therapists expert in neurorehabilitation, following a physical therapy protocol, which includes stretching, aerobic excercise and muscle strengthening.
15834992|NCT04164797|Drug|endostar+chemoradiotherapy|antiangiogenic drug+chemoradiotherapy
15834993|NCT04164797|Other|chemoradiotherapy|chemoradiotherapy
15834994|NCT04164784|Behavioral|therapeutic monitoring|According to the glucose lever recorded by FreeStyle Libre H (Flash Continuous Glucose Monitoring System) ,the investigators give the intervention group instructions to adjust their diet and lifestyle to abtain a good glucose control.
15834995|NCT04164771|Other|Aerobic training and Moringa Oleifera|Aerobic exercises/training refers to any type of rhythmic, continuous physical activities that use large group of muscles like walking, running, cycling, and swimming consuming additional amount of energy while Moringa Oleifera a plant from the family Moringacea, its products are used as a health supplement introduced in Africa and south Asian countries to cure many diseases and improve health status
15834996|NCT04164758|Drug|Pimavanserin|Pimavanserin 34 mg (provided as 2×17 mg encapsulated tablets) administered orally as a single dose once daily
15834997|NCT04164758|Other|Placebo|Placebo (provided as 2 × placebo encapsulated tablets) administered orally as a single dose once daily
15834998|NCT04164758|Drug|Quetiapine|Quetiapine 25 mg (provided as 1×25 mg quetiapine encapsulated tablet and 1 × placebo encapsulated tablet), OR 50 mg (provided as 2×25 mg quetiapine encapsulated tablets), OR 100 mg (provided as 2×50 mg quetiapine encapsulated tablets) administered orally as a single dose once daily
15834999|NCT04164745|Drug|Anlotinib, oral capsule|Participants receive Anlotinib 12 mg p.o, qd on Days 1-14 of each 3-week cycle until progressive disease or unacceptable toxicity plus pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).
15835000|NCT04164745|Biological|Pembrolizumab|Participants receive Anlotinib 12 mg p.o, qd on Days 1-14 of each 3-week cycle until progressive disease or unacceptable toxicity plus pembrolizumab 200 mg via intravenous (IV) infusion on Day 1 of each 3-week cycle for up to 35 administrations (up to approximately 2 years).
15835003|NCT04164719|Drug|TNX-102 SL|Subjects will place TNX-102 SL sublingual tablets under the tongue until dissolved, and not to crush or chew them
15835004|NCT04164706|Device|HumiGard device|HumiGard is a CE marked device that delivers warmed humidified CO2 during laparoscopic surgery
15835005|NCT04164706|Other|Standard care (with sham HumiGard device)|Standard methods of keeping the patient warm whilst in theatre, including warmed IV fluids, warming blankets/forced air warming devices.
15835006|NCT04164693|Drug|Low molecular weight heparin|patients began to use low molecular weight heparin or warfarin sodium tablets.
15835007|NCT04164693|Other|non anticoagulant therapy group|no anticoagulant was used after operation.
15835008|NCT04164680|Diagnostic Test|Multimodal Neuroimaging|fludeoxyglucose (FDG-)PET/MR imaging
15835009|NCT04164667|Behavioral|Directed instruction of the combined intervention of physical activity and mindfulness meditation|By using the VA's ANNIE text messaging systems, the participant's will receive detailed guidance on the exercise and mindfulness session.
15835010|NCT04164667|Behavioral|Self-guided practice of the combined intervention of physical activity and mindfulness meditation|The participants will receive the same goals about exercise and mindfulness practice, but without the added text messages where explicit instruction will be provided
15835011|NCT04164654|Behavioral|Loneliness Intervention|28 days of engagement with the Nod app, which consists of interactive exercises drawn from cognitive behavioral therapy (e.g behavioral activation and cognitive reframing exercises), positive psychology (e.g. acts of kindness), and mindful self-compassion programs (e.g. loving-kindness meditations)
15835012|NCT04164641|Device|Noraxon myoRESEARCH™ Software Gait Analysis Evaluation and Orthotic|Physical therapy evaluation (range of motion, strength, mobility, scale). Noraxon based gait assessment on treadmill while barefoot and with instrumented inner soles. Over ground walking assessment (with wireless instrumented inner soles, observational gait analysis while climbing stairs, ramps, curbs). Noraxon gait assessment and walking on treadmill will be video recorded for assessment. Standard measure of functionality and 6 minute walk test will be conducted. Patient will be fitted with corrective orthotics, based on usual care. Physical therapy re-evaluation. Noraxon based gait assessment and foot assessment (any areas of irritation, callus formation, swelling, ulcer formation, and gait mobility irregularities will be monitored and reassessed) throughout the study.
15835013|NCT04164628|Other|Quality of life assessment|Quality of life will be assessed with Nottingham Health Profile
15835014|NCT04164615|Drug|GB221|"GB221:Lyophilized powder for injection; strength 110mg/bottle; the first administration of 8 mg/kg, intravenous drip for over 90 minutes; subsequently, the administration shall be given once every 3 weeks (one cycle), the dose is 6 mg/kg, intravenous drip for 30~90 minutes; The administration shall be continued until disease progression or presence of intolerable toxic reactions or subject's active withdrawal from clinical study.
~Capecitabine:Tablets; 500mg/tablet, 12 tablets/box; Total daily dose 2000 mg/m2, orally twice daily, one dose each in the morning and evening, administration for 2 weeks followed by a 1-week rest period, as a 3-week cycle. The administration shall be continued until disease progression or presence of intolerable toxic reactions or subject's active withdrawal from clinical study."
15835015|NCT04164615|Drug|Placebo control|"Placebo control:Lyophilized powder for injection; strength 110mg/bottle; the first administration of 8 mg/kg, intravenous drip for over 90 minutes; subsequently, the administration shall be given once every 3 weeks (one cycle), the dose is 6 mg/kg, intravenous drip for 30~90 minutes; The administration shall be continued until disease progression or presence of intolerable toxic reactions or subject's active withdrawal from clinical study.
~Capecitabine:Tablets; 500mg/tablet, 12 tablets/box; Total daily dose 2000 mg/m2, orally twice daily, one dose each in the morning and evening, administration for 2 weeks followed by a 1-week rest period, as a 3-week cycle. The administration shall be continued until disease progression or presence of intolerable toxic reactions or subject's active withdrawal from clinical study."
15835016|NCT04164589|Device|SCENAR 1NT-02.2|The neuro-adaptative regulation will be carried out in vulvo-perineal and sacral area
15835017|NCT04164576|Genetic|Transplant patients|Study the specific immunity against Polyomavirus
15835018|NCT04164563|Device|Even-Up|Orthotic shoe lift worn on contralateral foot to increase leg length
15835019|NCT04164524|Drug|Gentamycin|Gentamycin 160 mg spray applied over the mesh
15835020|NCT04164511|Dietary Supplement|2 daily standard doses of vanilla-chocolate ice cream (cryotherapy)|The patients will receive 2 daily standard doses of vanilla-chocolate ice cream (cryotherapy) for 2 weeks post-op, with amount of analgesic consumption and subjective pain levels recorded on a VAS scale.
15835021|NCT04164498|Other|music|exposure to music to investigate its effects on reducing noise adverse effects
15835022|NCT04164485|Biological|Functional collagen scaffold transplantation|Injectable collagen scaffold combined with autologous adipose-derived cells will be injected into submucosa of vocal cord and paraglottic space under the surgical microscope
15835023|NCT04164485|Biological|Autologous adipose cell transplantation|Autologous adipose-derived cells will be injected into the submucosa of vocal cord and paraglottic space under the surgical microscope
15835024|NCT04164472|Behavioral|Friend to Friend (F2F) with Coaching|Friend to Friend (F2F) with Coaching has 16 small group sessions and 8 classroom sessions as led by school staff with coaching from the Children's Hospital of Philadelphia (CHOP) research team. The program aims to improve problem solving and prosocial behaviors, and decrease aggressive behaviors.
15835025|NCT04164459|Drug|Xalost S|One drop one times a day in study eye
15835026|NCT04164459|Drug|Xalatan|One drop one times a day in study eye
15835027|NCT04164459|Drug|Taflotan-S|One drop one times a day in study eye
15835028|NCT04164446|Drug|Placebos|The placebo that will be used contains starch and glucose.
15835029|NCT04164446|Dietary Supplement|Oil Palm Phenolics|One capsule contains 250 mg OPP or 1 g OPP
15835030|NCT04164433|Device|Oral HIV Self-Test (OraQuick)|The oral HIV self-test is a device for taking a test which is painless. The user gently swipes the test swab along the upper gums once and the lower gums once. The swab is then inserted inside the test tube provided and results are ready in 20 minutes.
15835031|NCT04164420|Behavioral|Oral neuromuscular training and orofacial sensory-vibration|Oral neuromuscular training is performed by using an oral device. The device is placed pre-dentally behind closed lips, and the participant is sitting in an up-right position. The participant is the instructed to hold the device against a gradually-increasing horizontal pulling force for 5-10 s, whilst trying to resist the force by tightening the lips and pressing the head backward against a head rest.
15835032|NCT04164420|Behavioral|Orofacial sensory-vibration stimulation|All participants in the control group is given orofacial sensory-vibration stimulation by using an electrical toothbrush. Instructions is given on how to stimulate the buccinator mechanism, lips, external floor, and the tongue three times daily before a meal.
15835033|NCT04164394|Other|Placebo|Placebo treatment (maltodextrin), once daily (u.i.d)
15835034|NCT04164394|Dietary Supplement|I31 Probiotic|I31 probiotic formula (dietary supplement), consisting of 3 billion cfus of strains P. acidilactici CECT7483, L.plantarum CECT7484 and L.plantarum CECT7485, once daily (u.i.d)
15835035|NCT04164381|Device|Robotic assisted intervention|Robotic treatment of the upper limb (30 sessions, 5 times a week) using a set of 4 robotic devices: Motore (Humanware); Amadeo, Diego, Pablo (Tyromotion). The training will include motor-cognitive exercises specifically selected to train spatial attention, vision and working memory, praxis, executive function, and speed of processing.
15835036|NCT04164368|Drug|Lenalidomide combined with R-CHOP|rituximab 375 mg/m2,ivgtt D1 cyclophosphamide 750 mg/m2 iv D2 vincristine 1.4 mg/m2 [capped at 2.0 mg], iv D2 doxorubicin 50 mg/m2 iv D2 prednisone 100 mg/m2 per day PO D2-6 Lenalidomide 25mg PO QD D2-11
15835037|NCT04164355|Drug|Tadalafil 20 MG|To study retinal and choriocapillary features in patients undergoing Tadalafil 20 mg orally, on alternate days, at baseline and 1, 3, 6 months after radical prostatectomy
15835038|NCT04164342|Other|surveys|Phone interviews to pass the Brief Pain Inventory (BPI) and the Patient Health Questionnaire-2 (PHQ-2) questionnaires (this is the intervention, since questionnaires at not usually done) at 3, 6 and 12 months after ICU discharge.
15835039|NCT04164329|Drug|General anesthetic|General anesthesia (propofol, fentanyl, sevorane, remifentanyl, rocuronium)
15835040|NCT04164316|Device|Kinesio Tape|Kinesio TexTM Tape which is the original elastic therapeutic adhesive tape which is a latex-free, hypoallergenic, waterproof, porous.
15835041|NCT04164303|Other|Physical Therapist management|Physical Therapist management included joint manipulation, mobilization with movement, strengthening exercises, and grip proprioception training.
15835042|NCT04164290|Drug|Jiashen Tablets|1 tablet
15835043|NCT04164290|Drug|Jiashen Tablets|2 tablets
15835044|NCT04164290|Drug|Jiashen Tablets|4 tablets
15835045|NCT04164290|Drug|Jiashen Tablets|6 tablets
15835046|NCT04164290|Drug|Jiashen Tablets|8 tablets
15835047|NCT04164290|Drug|Jiashen Tablets|9 tablets
15835048|NCT04164290|Drug|Jiashen Tablets Placebo|1 tablet
15835049|NCT04164290|Drug|Jiashen Tablets Placebo|2 tablets
15835050|NCT04164290|Drug|Jiashen Tablets Placebo|4 tablets
15835051|NCT04164290|Drug|Jiashen Tablets Placebo|6 tablets
15835052|NCT04164290|Drug|Jiashen Tablets Placebo|8 tablets
15835053|NCT04164290|Drug|Jiashen Tablets Placebo|9 tablets
15835054|NCT04164277|Behavioral|Caregiver Component.|Facebook-based program including four new habit-formation tasks/week. Three face-to-face or virtual caregiver meetings: Meeting 1: Study orientation and healthy cooking education will be offered, and each family will receive a small bag of groceries to facilitate preparation of a recipe at home. Each caregiver will also receive an intervention cookbook containing affordable slow-cooking recipes, quick-fix recipes, and healthy snack ideas. Meeting 2: Study interveners will demonstrate how to spend less and shop healthy and how to read nutrition fact labels to promote healthy purchasing behaviors. Meeting 3: Study interveners will present healthy eating and PA community resources (e.g., farmer's markets, community gardens, nearly parks or other free or affordable PA facilities) and provide caregivers a resource booklet.
15835080|NCT04164147|Device|one of the Persona MC Retained PCL, Persona MC Sacrificed PCL and NexGen PS total knee implant|Participant are randomly allocated to receive one of the Persona MC Retained PCL, Persona MC Sacrificed PCL and the NexGen PS total knee implant for treatment of end-stage knee osteoarthritis.
15835128|NCT04163835|Drug|Twice Normal-dose Wenxin Granules|"The drugs should be taken 10 g orally each time, 3 times a day after meals, for 4 weeks.
~Ingredients: Wenxin Granules (no sucrose) 10g."
15835215|NCT04163029|Procedure|Preoperative oral care|tooth brushing and mouthwash with chlorhexidine 0,2% five day before surgery
15835055|NCT04164277|Behavioral|Caregiver-Preschooler Learning.|Preschoolers, using stickers, will create two letters each week regarding a food or activity presented in the center-based program that they liked or want to try at home. Letters will be sent by the PM privately to each caregiver via Facebook messenger on two weekdays. Caregivers will be asked to answer two Facebook multiple-choice questions related to the letters each week by Sunday midnight (e.g., what foods listed in the their child's letter did the participant provide? and what activities listed in the their child's letter did the participant's family try?). Caregiver responses to the questions will be summed to indicate caregiver responses to child requests. Each preschooler's letters will be kept in his/her intervention binder with other intervention materials to present to his/her caregiver at Meeting 3. Weekly preschooler activities, with pictures or videos, will be shared with caregivers via the Facebook private group every week.
15835056|NCT04164277|Behavioral|Center-based Preschooler Component.|"Built on previous research, preschoolers will receive weekly, age-appropriate, participatory learning co-delivered by teachers and MSU student educators. Session duration will be 20 minutes because children's normal attention span is 3-5 minutes per year of age, and 20 min/session is recommended for preschoolers. The already developed Eat & Walk My ABCs curriculum will be implemented. The curriculum includes four components: healthy eating learning, taste-testing activities, movement skill training, and fun physical activity."
15835057|NCT04164264|Drug|Propofol|At T0, a propofol infusion at a rate of 1.5 mg/kg/min will be started until apnea is achieved. Loss of consciousness will be defined clinically using loss of eyelash reflex (TLOER) and tolerance of nasal cannulae (TNC), tested every 10 sec., and by a BIS <60 for 30 sec. (TBIS). Apnea will be defined as absence of end-tidal CO2 for at least 20 seconds (TAPNEA). A saliva sample with be taken under anesthesia for genome-wide association study and principal component analysis.
15835058|NCT04164251|Other|Screening mammography|The purpose of the study was to evaluate the feasibility of securing inpatient breast cancer screening mammograms for non-adherent hospitalized women prior to hospital discharge.
15835059|NCT04164238|Drug|Toripalimab|Toripalimab Injection
15835060|NCT04164238|Drug|Paclitaxel|Paclitaxel Injection
15835061|NCT04164238|Drug|Carboplatin|Carboplatin Injection
15835062|NCT04164238|Drug|Cisplatin|Cisplatin injection
15835063|NCT04164238|Drug|5-fu|5-fu injection
15835064|NCT04164225|Behavioral|Qigong Exercise|"Participants with chronic low back pain will follow the free 5 elements Qigong healing class (estimate of 6 hours) at the Spring Forest Qigong center and then practice the 5 elements healing Qigong at home 3 times a week for 40 minutes with a freely available online video, for 12 weeks. A weekly group session (1 hour) will be conducted at the Brain Body Mind Lab with the principal investigator to address questions and demonstrate movements if needed."
15835065|NCT04164225|Behavioral|P.Volve Exercises|P.Volve exercise focuses on low impact core strengthening, core stabilization, and stretching. The program is similar in delivery as Qigong (i.e., online videos). An introductory class (estimate of 2.5h) will be given by the P.Volve team, the principal investigator, and a physical therapist who has experience with P.Volve exercises. Participants will access online videos for individual home practice in 40min/session, 3x/week for 12 weeks. Participants will receive a P.ball for some exercises, while other exercises are done with no equipment. Tailored videos will be available for those with cLBP. A weekly group session (1 hour) will be conducted at the Brain Body Mind Lab with the principal investigator to address questions and demonstrate movements if needed.
15835066|NCT04164212|Drug|Flumist Quadrivalent Nasal Product|FLUMIST QUADRIVALENT 0.2 mL dose supplied in a single-dose pre-filled intranasal sprayer
15835067|NCT04164199|Drug|Tislelizumab 200 mg, IV|Day 1 of each 21-day cycle, to be administered until disease progression, unacceptable toxicity, the start of new anticancer therapy, withdrawal of consent, study termination by the sponsor, or death, whichever occurs first.
15835068|NCT04164199|Drug|Pamiparib 20, 40, 60 mg PO Twice Daily (BID)|To be administered until disease progression, unacceptable toxicity, the start of new anticancer therapy, withdrawal of consent, study termination by the sponsor, or death, whichever occurs first.
15835069|NCT04164199|Drug|Pemetrexed 500 mg/m² IV|To be administered until disease progression, unacceptable toxicity, the start of new anticancer therapy, withdrawal of consent, study termination by the sponsor, or death, whichever occurs first.
15835070|NCT04164199|Drug|Capecitabine 1000 mg/m² PO BID|Day 1 to Day 15 of each 21 day cycle, to be administered until disease progression, unacceptable toxicity, the start of new anticancer therapy, withdrawal of consent, study termination by the sponsor, or death, whichever occurs first.
15835071|NCT04164199|Drug|Temozolomide 120, 80, 40 or 20 mg PO Once Daily (QD)|To be administered until disease progression, unacceptable toxicity, the start of new anticancer therapy, withdrawal of consent, study termination by the sponsor, or death, whichever occurs first.
15835072|NCT04164186|Other|Automatic detection and segmentation of NSCLC tumors|an automated deep learning detection and segmentation software for non-small cell lung cancer (NSCLC) that can automatically detect and segment tumors on CT scans and thus reduce the human variation.
15835073|NCT04164173|Device|EzPAP|Patient will receive 10 min EzPAP 4 times daily
15835074|NCT04164173|Device|Metaneb|Patient will receive 10 min Metaneb 4 times daily
15835075|NCT04164173|Device|Intermittent Positive Pressure Breathing (IPPB)|Patient will receive 10 min IPPB 4 times daily
15835076|NCT04164160|Other|integrated-care-model benefiting group|Patients will be called for the ﬁrst interview of the study by the healthcare professional. Their data will be automatically entered in the Salut + Social app, they will be asked to respond to the study questionnaires (ad hoc questionnaire for sociodemographic data, EuroQol-5D, Zarit questionnaire and Morisky-Green test) and will take part in the future actions to be planned for them. Patients will receive an appointment to attend their PCC at 6, 9, and 12 months after their incorporation into the program. In those follow-up, the same questionnaires will be provided together with the IEXPAC questionnaire, which evaluates the experience of the chronic patient with the new care model.
15835077|NCT04164147|Procedure|Total knee replacement|Participant will undergo total knee replacement performed via anterior parapatellar approach with either Posterior Cruciate Ligament sacrificing or retaining implant
15835078|NCT04164147|Diagnostic Test|CT scan|CT scans of the affected knee joint before and after the surgical procedure
15835079|NCT04164147|Diagnostic Test|Biomechanics|Participants will be asked to perform biomechanical assesment before and following surgery at baseline, 6-8 weeks and 6-months postoperatively
15835081|NCT04164134|Other|blood draw|"Control samples for the Rb survivor group (adult) are already available at the VUMC for the platelet study; unselected volunteers from an anti-cancer campaign. Control samples (adult) for the EV study will be collected in a blooddrive at the Essen site.
~Pediatric patients. For the pediatric Rb patients, blood draw is part of standard care (3mth-4y). The control blood samples of healthy children (12) will be drawn from healthy children, where the blood draw is already part of otherwise planned care (e.g. patients which are completely healthy besides having an unrelated problem for which surgery is required). Controls will be age-matched as much as possible."
15835082|NCT04164121|Drug|Phenlarmide Tablets|Oral administration was conducted on an empty stomach, and the drug was administered once a day on day 1 and once a day from day 8 to day 17.
15835083|NCT04164121|Drug|Placebos|Oral administration was conducted on an empty stomach, and the drug was administered once a day on day 1 and once a day from day 8 to day 17.
15835084|NCT04164108|Dietary Supplement|Intermittent Enteral Nutrition Protocol|Patients will receive total recommended nutrition divided into four equal meals, delivered at a rate of 400 cc/hr at 8:00, 12:00, 16:00, 20:00. Titration schedule will include administering 50% of volume for first two feeds, then 75%, and then 100%.
15835085|NCT04164095|Procedure|lappg|Preservation of pylorus and vagus nerve by laparoscopy
15835088|NCT04164069|Biological|Bevacizumab|Given IV
15835089|NCT04164069|Drug|Dasatinib|Given PO
15835090|NCT04164069|Drug|Fluorouracil|Given IV
15835091|NCT04164069|Drug|Leucovorin|Given IV
15835092|NCT04164069|Drug|Leucovorin Calcium|Given IV
15835093|NCT04164069|Drug|Oxaliplatin|Given IV
15835094|NCT04164069|Other|Quality-of-Life Assessment|Ancillary studies
15835095|NCT04164056|Device|deep brain stimulation|deep brain stimulation on the hippocampus or the anterior nucleus of the thalamus
15835096|NCT04164043|Behavioral|Wellness Recovery Program|12-week community-based recreation therapy
15835097|NCT04164030|Behavioral|Education and Exercise Program for Adults with Type 2 Diabetes|Eating Smart and Being Active program
15835098|NCT04164030|Behavioral|Nutrition Education plus Occupational Therapy plus Yoga|multimodal interdisciplinary approach
15835099|NCT04164017|Device|EUS-guided FNB with Syringe Suction|For each case, FNB will be performed using two punctures: one with 20mL syringe suction and another without aspiration. The order in which they will be performed will be known only by the performing physician and the nursing team at the time that FNB is proposed. This information will be concealed from the pathologist responsible for sample analysis.
15835100|NCT04164017|Device|EUS-guided FNB without Syringe Suction|For each case, FNB will be performed using two punctures: one with 20mL syringe suction and another without aspiration. The order in which they will be performed will be known only by the performing physician and the nursing team at the time that FNB is proposed. This information will be concealed from the pathologist responsible for sample analysis.
15835101|NCT04164004|Other|Kansas City Cardiomyopathy Questionnaire-12|Health status assessment will be completed using the well-validated Kansas City Cardiomyopathy Questionnaire-12 prior to or at the time of heart failure clinic visits.
15835102|NCT04163991|Drug|VIB4920|VIB4920 Dose 1 or 2 will be administered intravenously per dosing interval of 1 or 2 or 4.
15835103|NCT04163991|Drug|Placebo|Placebo will be administered intravenously per dosing interval of 1 or 3 or 5.
15835104|NCT04163978|Drug|Nitric Oxide|in situ 240mL nitric oxide releasing sinus irrigation solution
15835105|NCT04163978|Drug|Budesonide|Saline based sinus irrigation 1mg Budesinide solution
15835106|NCT04163965|Device|Capacitive ECG|Patients having a pacemaker will sit down on a seat bearing capacitive ECG electrodes during their routine heart checkup at the cardiology.
15835107|NCT04163952|Biological|Panitumumab|Given IV
15835108|NCT04163952|Biological|Talimogene Laherparepvec|Given IM
15835109|NCT04163939|Other|Vista Therapy Collar|The patient will wear the cervical collar
15835110|NCT04163939|Other|Placebo|The patient will not wear the cervical collar
15835111|NCT04163926|Procedure|Intervention Group cataract follow up|Intervention group will have cataract follow up conducted by the referring optometrist 4-6 weeks after surgery
15835112|NCT04163926|Procedure|Usual Care consultant follow up|Usual care group - Consultant led post op follow up
15835113|NCT04163913|Other|Change in User interfaces of Cirvo compression device application.|Comparison of 2 versions of the Circo user interface
15835114|NCT04163913|Other|Change in Satisfaction in use of Cirvo device|Comparison of how satisfied patients are with the Cirvo device to a different compression device (ActiveCare)
15835115|NCT04163900|Drug|NUC-1031|IV infusion in 500 mL of 0.9% sterile saline for injection given over 30 minutes
15835116|NCT04163900|Drug|Gemcitabine|IV infusion in 250 mL of 0.9% sterile saline for injection given in accordance with the package insert
15835117|NCT04163900|Drug|Cisplatin|IV in accordance with local institutional practice for biliary tract cancer, including the use of an appropriate hydration protocol
15835118|NCT04163887|Procedure|hepatectomy|Resection colorectal liver metastases using a laparoscopic approach or an open approach.
15835119|NCT04163874|Drug|Fiasp|Fiasp Insulin delivered in a basal-bolus manner.
15835120|NCT04163874|Drug|Pramlintide Acetate|Pramlintide delivered in a basal-bolus manner with a fixed ratio with insulin.
15835121|NCT04163874|Drug|Placebo|Placebo delivered in a basal-bolus manner with a fixed ratio with insulin.
15835122|NCT04163874|Device|Artificial Pancreas|Tandem insulin pump, dexcom G5 sensor, Nexus 5 cellphone running the iMAP algorithm.
15835123|NCT04163861|Diagnostic Test|2d speckle tracking echocardiography|2d speckle tracking echocardiography
15835124|NCT04163861|Diagnostic Test|serum BNP level|serum BNP level of HFpEF study subjects
15835125|NCT04163848|Other|Pollution|CO2 equivalent productions related to anesthetic gases use during general anesthesia for laparoscopic surgery
15835126|NCT04163835|Drug|Normal-dose Wenxin Granules|"The drugs should be taken 10 g orally each time, 3 times a day after meals, for 4 weeks.
~Ingredients: Wenxin Granules (no sucrose) 5g + Wenxin Granules placebo 5g."
15835127|NCT04163835|Drug|1/2 Normal-dose Wenxin Granules|"The drugs should be taken 10 g orally each time, 3 times a day after meals, for 4 weeks.
~Ingredients: Wenxin Granules (no sucrose) 2.5g + Wenxin Granules placebo 7.5g."
15835129|NCT04163835|Drug|Placebo|"The drugs should be taken 10 g orally each time, 3 times a day after meals, for 4 weeks.
~Ingredients: Wenxin Granules placebo 10g."
15835130|NCT04163822|Other|no intervention|no intervention, only observation
15835131|NCT04163809|Device|Virtual Reality with Oculus Go headset|The investigator will place the Oculus Go VR headset on the patient. VR will provide distracting, pleasant visual stimulus from the beginning of the procedure (while the patient is being cleaned and draped) and removed immediately after the regional anesthesia procedure is complete for roughly 10-20 minutes. All patients receiving VR will view the same scene.
15835132|NCT04163796|Device|UPnRIDE power wheelchair|The intervention will consist of approximately 3.5 hours per session, 3 times per week over 12 weeks. During each 3.5-hour session, subjects will be asked to stand at least 5 minutes during every 15 minutes or more as tolerated. One time each session, participants will be asked to perform the Activities of Daily Living course.
15835133|NCT04163783|Drug|[14C]-BGB-3111|20-mg capsule containing ~200 μCi of [14C]-BGB-3111,
15835134|NCT04163783|Drug|BGB-3111|Three 20-mg capsules of BGB-3111 and three 80-mg capsules of BGB-3111
15835135|NCT04163770|Device|caliberation of pacemaker|evaluation of ventricular impedence, ventricular sensing, ventricular capture threshold
15835136|NCT04163770|Device|caliberation of pacemaker|evaluation of ventricular impedence, ventricular sensing, ventricular capture threshold
15835137|NCT04163757|Dietary Supplement|crocin|2 tablets crocin per day
15835138|NCT04163757|Dietary Supplement|placebo|2 tablets placebo per day
15835139|NCT04163744|Device|Double balloon catheter|Induction of labour with double balloon catheter
15835140|NCT04163731|Other|DASI questionnaire|All patients who accept to participate will undergo a self-questionnaire of 10 minutes. Medical data of their cardiac stress test and risk factor will be collected.
15835141|NCT04163718|Drug|Umbralisib|800 mg Umbralisib will be self-administered on an outpatient basis. Umbralisib will be taken orally once daily within 30 minutes of a meal until removal from study. This treatment will be administered in 4 week (28-day) cycles.
15835142|NCT04163705|Diagnostic Test|blood sample collection|Routine Laboratory Analysis
15835143|NCT04163692|Other|Progressive relaxation exercises|"Following intructions have been performed by patients:
~Punch your hands and contract your forearm
~Punch your hands, push your elbow towards the seat
~Bend your elbows
~Push your shoulders back
~Press your knee down and pull your toes towards you
~Pull your knees towards you and push your feet down
~Tighten your hips
~Push your head back
~Lift your eyebrows
~Make wrinkles on your nose
~Tighten your teeth
~Push your chin down
~Close your eyes and think of good things."
15835144|NCT04163679|Procedure|Vaginal Preparation|"One sponge stick will be inserted into the vagina, where it will stay during the scrubbing of thighs and genitals.
~One sponge will be used to scrub the right inner thigh from mid-thigh to right labia majora. This sponge will then be discarded.
~A second sponge will be used to scrub the left inner thigh from mid-thigh to left labia majora. This sponge will then be discarded.
~A third sponge will be used to scrub the mons pubs, labia majora and minor, perineum and rectum in that order then will be discarded. This will be repeated with a fourth sponge.
~The existing sponge stick in the vagina will be rotated in the vagina twice then removed. This will be discarded.
~A second sponge stick will be inserted in the vagina, rotated twice then removed. As it is removed from the vagina, the perineum and rectum will be swabbed with the stick in that order then discarded. This will be repeated using a third sponge stick."
15835145|NCT04163666|Behavioral|Mirror therapy|The intervention will take place at the home of the participant for 6 weeks (30 days), during 60-minute sessions, 30 of which will be for mirror therapy, while the remaining 30 minutes will be for task-oriented motor learning
15835146|NCT04163666|Behavioral|Cognitive therapeutic exercise|The intervention will take place at the home of the participant for 6 weeks (30 days), during 60-minute sessions, 30 of which will be for cognoscitive therapeutic exercise, while the remaining 30 minutes will be for task-oriented motor learning
15835147|NCT04163653|Diagnostic Test|Non-contrast MRI|Classification and characterization of the lymphatic vasculature using non-contrast MRI.
15835148|NCT04163653|Diagnostic Test|Cardiopulmonary exercise test|Cardiopulmonary exercise test, measurement of VO2 and heart rate.
15835149|NCT04163640|Other|intra-ovarian platelet rich plasma injection|patients will undergo a transvaginal intra-ovarian platelet rich plasma injection
15835150|NCT04163614|Other|IBPS-Guided Ultrafiltration|Each month, the study investigator will review the average intradialytic blood pressure slope from the prior two weeks. A prespecified algorithm will be used to prescribe additional fluid removal/weight reduction based on this slope.
15835151|NCT04163588|Drug|Metolazone|Study participants receive loop diuretics plus oral metolazone at a dose of 5/10 mg once daily
15835152|NCT04163588|Drug|Loop Diuretics|Study participants receive a standard diuretic strategy (intravenous loop diuretics as recommended by current guidelines plus placebo)
15835153|NCT04163575|Biological|:Anti-CD22-CAR|Cells extracted, followed by induction chemotherapy before CD22-CAR infusion (dose escalation.)
15835154|NCT04163562|Drug|INP20|Part A: Oral INP20 administration at ascending doses once daily for 2 weeks. Part B: Two doses of oral INP20 derived from Part A once daily for 6 months.
15835155|NCT04163562|Drug|Placebo|Part A: Oral placebo administration onces daily for 2 weeks. Part B: Oral placebo administration onces daily for 6 months.
15835156|NCT04163549|Behavioral|Safe at Home|Discussion-based intervention
15835157|NCT04163536|Drug|Methylprednisolone|In the experimental group, methylprednisolone will be administered intravenously for 5 days at a dose of 1 mg/kg/day. Methylprednisolone will be provided for reconstitution and dilution in 50 ml of NaCl 0.9% solution and administered over 15 minutes, once a day.
15835158|NCT04163536|Drug|Placebos|in the control group, placebo will be administered intravenously for 5 days. Placebo will be identical (color and aspect) to experimental substance, will be provide as a 50 mL of NaCl 0.9% solution and administered intravenously over 15 minutes, once a day.
15835159|NCT04163523|Drug|Zanubrutinib|
15835189|NCT04163289|Drug|Fecal Microbiota Transplantation|Fecal microbiota transplantation is the process of administering stool samples derived from healthy donors, which have been processed and prepared into capsules. Capsules will be taken 7 days or more prior to the first treatment with nivolumab and ipilimumab, and 1 to 3 days prior to the next 2 treatments with nivolumab and ipilimumab.
15835190|NCT04163276|Diagnostic Test|18F FDG PET exam|All patients have received 18F-FDG PET/CT in nuclear medicine
15835160|NCT04163510|Behavioral|Behavioral: Parent/Child Reading Program|A 9-week parent/child reading program will help parents to identify strategies to establish literacy routines with their children, and to engage with them in enjoyable literacy activities that promote skill building while reducing negative feelings associated with reading. Three large-group sessions will be held in a central location, to build community and rapport among researchers and participants. Six individual sessions will take place in the participants' homes, to customize reading strategies and routines to each family's home setting and personal interests. Intervention sessions will be held once per week for 60-90 minute sessions.
15835161|NCT04163497|Device|ICU Diaries|To explore the effects of providing an ICU Diary in the symptoms of anxiety, depression and PTSD within patients who were hospitalized in the unit.
15835162|NCT04163484|Other|Iodinated contrast|Intra-arterial injection of iodinated contrast media during percutaneous coronary intervention
15835163|NCT04163471|Device|Radial artery mechanical compression for hemostasis|Transradial hemostasis following arterial catheterization procedures
15835164|NCT04163458|Drug|MENOPUR solution for injection in pre-filled pen, 1200 IU/1.92 mL|Solution for injection in pre-filled pen, subcutaneous administration
15835165|NCT04163458|Drug|MENOPUR powder and solvent for solution for injection, 75 IU|Solution for injection in vials (powder and diluent), subcutaneous administration
15835166|NCT04163458|Other|Placebo (for MENOPUR solution for injection in pre-filled pen)|Solution for injection in pre-filled pen, subcutaneous administration
15835167|NCT04163458|Other|Placebo (for MENOPUR powder and solvent for solution for injection)|Solution for injection in vials (powder and diluent); subcutaneous administration
15835168|NCT04163445|Device|MicroPort Orthopedics EVOLUTION Medial Pivot TKA|Subjects will have been implanted with the Microport Evolution Medial Pivot TKA
15835169|NCT04163445|Device|Depuy Synthes ATTUNE PCR TKA|Subjects will have been implanted with the Depuy Attune PCR TKA
15835170|NCT04163432|Drug|Durvalumab|Durvalumab is administered at a dose of 1500mg for patients who weigh >30 kg. If weight falls to ≤ 30 kg, weight-based dosing at 20mg/kg will be a utilized
15835171|NCT04163432|Drug|Pemetrexed|Pemetrexed dosing is adjusted for kidney function. Pemetrexed is dosed at 500mg/m2 for patients with a creatinine clearance ≥ 45 mL/min (by Cockcroft-Gault formula). If creatinine clearance is < 45 mL/min, pemetrexed is dosed at 400 mg/m2.
15835172|NCT04163432|Drug|Carboplatin|Carboplatin dosing is adjusted for kidney function.The total dose (in mg) of carboplatin will be calculated using the Calvert Formula utilizing a target AUC of 5 and a patient's GFR in mL/min.
15835173|NCT04163419|Drug|Tanezumab|Tanezumab 10 mg SC
15835174|NCT04163419|Drug|Placebo|Placebo 10 mg SC
15835178|NCT04163393|Procedure|Percutaneous Coronary Intervention|PCI with robotic assistance
15835179|NCT04163393|Device|Percutaneous Coronary Intervention using R-One assistance|PCI with robotic assistance
15835180|NCT04163380|Behavioral|Resistance Training|Participants will exercise at the mid-point of each menstrual cycle phase (EFP- day 4, LFP- day 11, ELP- day 18 and LLP- day 25 for a 28 day menstrual cycle). Training will consist of a warm up. Intensity will be set at 70% of 1RM, and the circuit training will include 7 strength exercises: leg press, rows, back squat, weighted crunches, deadlifts, bench press, and weighted squat jumps. The participant will perform 3 sets f 10 repetitions with 30 seconds of rest
15835181|NCT04163367|Behavioral|Safer Kids|A behaviorally based parent training program with the purpose to reduce or prevent child abuse.
15835182|NCT04163367|Other|Intervention as usual (IAU)|Everything that's included in the social service units' regular handling of cases; such as the formal investigation and family treatment. The units cannot offer Safer Kids as a part of IAU.
15835183|NCT04163354|Procedure|5% sodium fluoride varnish (NaF)|In the NaF varnish groups, 0.25mL (one drop) of the varnish is placed in a plastic dappen dish. A disposable microbrush is used to apply the varnish onto the second primary molars included in the study and all other teeth. The child is instructed not to eat or drink after the application of varnish for at least half an hour.
15835184|NCT04163354|Procedure|Glass ionomer sealant (GIS)|Glass ionomer sealants (GIS) is applied using the finger pressure technique described in the WHO manual for atraumatic restorative treatment (ART) (Frencken et al.; 1997). The primary second molars are cleaned by applying GC cavity conditioner with micro-applicator for 10-15 seconds, then clean with wet cotton pellets for several times. The surface will be dried with cotton pellets. GIS (GC Fuji VII) is mixed in standardized proportion with an amalgamator, then applied to the occlusal surface and slightly overfilled. A gloved finger with petroleum jelly will be used to push and rub the materials into the pits and fissures, and removing the excess. GIS will be covered and protected by a layer of petroleum jelly (Vaseline ®).
15835185|NCT04163341|Behavioral|Adapted Common Elements Treatment Approach|The intervention is a transdiagnostic cognitive behavioral therapy approach to treating any combination of depression, anxiety, post-traumatic stress, or substance use disorder that has been adapted the needs of adults with HIV and to additionally address HIV care engagement.
15835186|NCT04163328|Drug|HydroEye®|This is an omega-3 fatty acids supplement.
15835187|NCT04163315|Other|dMRI, fMRI and electrocorticography|Patients included in the study will perform the pre-operative MRI (fMRI and fMRI) with a specific High Resolution Angular Diffusion (HARDI) sequence and a functional rest sequence. The additional scan time for this specific sequence is approximately 25 minutes, with no foreseeable negative impact on the patient
15835188|NCT04163302|Biological|CD19-PD1-CART Cell|This study was a single-center, open-label, single-arm, non-randomized clinical trial, which has 3 groups by infusion dose level. Firstly, each dose group has 3 patients. The pretreatment regimen of cyclophosphamide (25mg/m2 for 3 consecutive days) and fludarabine (10mg/kg for 3 consecutive days) was given before CART cells were reinfused. CART cells were reinfused on the third day after the pretreatment. If no serious side effects emerges in the group, then the next group uses the subsequent higher dose. If serious side effects emerges in a single patients in any dose level, 3 more patients will be enrolled to the same dose level. After 9 or more patients, the investigators select the safest dose and recruit more patients for CART test to explore its effectiveness.
15835193|NCT04163250|Diagnostic Test|Urinary determination of TIMP-2/ IGFBP7|"Urinary determination of TIMP2-IGFBP7 in the an urine sample obtained within 12 hours prior to contrast administration. A single determination will be made, which will be sent to the laboratory. The doctor who treats the patient will not know the result of the test, and the treatment will not be influenced by the result.
~According to the manufacturer, 10 ml of fresh urine should be collected in a sterile container and the laboratory should centrifuge them within the time of collection.
~The result is reported as a single value calculated as the concentration of TIMP-2 (ng / mL) multiplied by the concentration of IGFBP7 (ng / mL) divided by 1000. The result is reported without units."
15835194|NCT04163237|Drug|PD-1|PD-1 (programmed death receptor 1), an important immunosuppressive molecule, is an immunoglobulin superfamily and is a membrane protein of 268 amino acid residues. It was originally cloned from apoptotic mouse T cell hybridoma 2B4.11. Immunomodulation targeting PD-1 has important implications for anti-tumor, anti-infective, anti- autoimmune diseases and organ transplant survival. Its ligand PD-L1 can also be used as a target, and the corresponding antibodies can also play the same role. PD-1 and PD-L1 bind to initiate programmed cell death of T cells, allowing tumor cells to gain immune escape.
15835195|NCT04163237|Drug|Sorafenib|Sorafenib tosylate is a novel multi- target anti-tumor drug developed by Bayer Pharmaceuticals, Germany, which acts on both tumor cells and tumor blood vessels. It has a dual anti-tumor effect: it directly inhibits tumor cell proliferation by blocking RAF/MEK/ERK-mediated cell signaling pathways, and also by inhibiting VEGFR and platelet- derived growth factor (PDGF) receptors. Blocking the formation of tumor neovascularization, indirectly inhibiting the growth of tumor cells.
15835196|NCT04163224|Device|RibFix Advantage|Class II device in the United States; consists of bridges (with locking posts) and locking caps for the thoracoscopic fixation and stabilization of ribs. These implants are manufactured from commercially pure titanium and titanium alloys. When fully assembled, the bridge plate is placed on the underside of the rib (pleural cortex); the threaded locking posts extend through pre-drilled holes in the rib, and the locking caps are fixed to the locking post on the anterior (cutaneous) side of the rib. The combined threaded locking post and cap provides for fixation of the bridge and stabilization of the fracture.
15835197|NCT04163211|Procedure|Abdominal drain|A latex-free drain (size 20F)
15835198|NCT04163198|Device|Insufflation|Patients will receive different inspiratory (Ti) and expiratory (Te) times and inspiratory flows, at a fixed insufflation and exsufflation pressure. Optimum insufflation pressure will be determined by measuring maximal inspiratory capacity.
15835199|NCT04163198|Device|Exsufflation|Patients will receive different exsufflation pressures at fixed insufflation pressure.
15835200|NCT04163185|Drug|AXS-07 (MoSEIC meloxicam and rizatriptan)|AXS-07 tablet taken once upon the earliest onset of migraine pain.
15835201|NCT04163185|Drug|Placebo|Placebo tablet taken once upon the earliest onset of migraine pain.
15835202|NCT04163172|Procedure|Surgical treatment of distal humeral fracture with elbow hemiarthroplasty|Latitude anatomical elbow hemiarthroplasty (WRIGHT -Memphis, Tennessee)
15835203|NCT04163172|Procedure|Surgical treatment of distal humeral fracture with double plating.|Double plating (Synthes - Switzerland and West Chester, Pennsylvania, United States)
15835204|NCT04163146|Diagnostic Test|Measurements of PEF and FEV1|Measurements of PEF and FEV1 at home, twice a day (07:00 - 09:00 and 19:00 - 21:00) and for a period of 3 months, using portable spirometers connected to smartphone
15835205|NCT04163133|Procedure|two days later trigger than regular timing|During ovarian stimulation, two days later of trigger after three follicles reach 17mm bilateral with contineous using of Gonadotrophin in antagonist protocol.
15835206|NCT04163120|Other|Low calorie Mediterranean ketogenic diet with phytoextracts (KEMEPHY)|The KEMEPHY diet (24-29) is a Mediterranean low calories ketogenic protocol (about 1000/1100 Kcal/day) with the use of some phytoextracts. During this protocol subjects are allowed to eat with no limits green leafy vegetables, cruciferous, zucchini, cucumbers and eggplants. The quantity of meat, eggs and fish was limited to once a day (120g of meat or 200g of fish or 1 egg) Table 1. Moreover, subjects daily consumed four food supplements and liquid herbal extracts. Food supplements are high proteins (19g/portion) and very low carbohydrate (3.5g/portion) formulas simulating the aspect and taste of common carbohydrate rich foods added with dry phytoextracts (30). Liquid herbal extracts were used for their draining /toning activity, useful to reduce some commonly reported light side effects of ketogenic diets as constipation, headache and halitosis.
15835207|NCT04163107|Drug|Hydroxychloroquine|All patients start with a 14 days run-in with monotherapy with hydroxychloroquine (HCQ) at their assigned dose level. Then they continue with 6 28-day cycles of HCQ/Carfilzomib/Dexamethasone. 3 patients at each dose level.
15835208|NCT04163107|Drug|Carfilzomib Injection|All patients start with a 14 days run-in with monotherapy with hydroxychloroquine (HCQ) at their assigned dose level. Then they continue with 6 28-day cycles of HCQ/Carfilzomib/Dexamethasone. 3 patients at each dose level.
15835209|NCT04163107|Drug|Dexamethasone|All patients start with a 14 days run-in with monotherapy with hydroxychloroquine (HCQ) at their assigned dose level. Then they continue with 6 28-day cycles of HCQ/Carfilzomib/Dexamethasone. 3 patients at each dose level.
15835210|NCT04163094|Drug|W_ova1 Vaccine|Patients will be treated with a W_ova1 vaccine that includes 3 OC TAA RNA-LPX products.
15835211|NCT04163081|Behavioral|Quit Card Intervention (QCI)|"The intervention is comprised of a behavioural incentive in the form of a gift card as well as tailored smoking cessation counseling. Eligible consenting smokers randomized to the QCI group will receive: a Quit Card (a gift card worth $300 that can be used to buy nicotine replacement therapies at any pharmacy); self-help information; and, enrollment in six months of telephone follow-up support tailored by treatment goal with a Nicotine Addiction Treatment Specialist."
15835212|NCT04163068|Other|Interview|The interview will last approximately 45 minutes, will be audio-recorded, transcribed, and analysed
15835213|NCT04163055|Device|Moleculight i:X|This device is used to visualize the bacteria in the wound. Patients do not need consume any contrast agent prior to imaging. The device does not come in contact with the wound.
15835214|NCT04163042|Behavioral|12-week videoconferencing behavioural support intervention to promote physical activity behaviour|Participants in Group A will receive six real-time, 1-on-1 60-minute sessions led by a physical activity counsellor over a 12-week period. Sessions will be delivered via videoconferencing and will aim to provide young adult cancer survivors with support as well as the knowledge, skills, and confidence to identify and overcome challenges to engaging in physical activity in order to increase physical activity behaviour and enhance patient-reported outcomes.
15835216|NCT04163016|Drug|Pharmacokinetics of certolizumab pegol|"The collection of blood samples for pharmacokinetics (PK) is considered interventional. Blood samples will be drawn at enrollment, predose every 4 weeks (Q4W), postdose every 8 weeks (Q8W) and postpartum predose and postdose.
~Study participants will be responsible for obtaining and administering commercially available approved dosing regimens of certolizumab pegol (CZP) as prescribed by each study participant's own physician."
15835217|NCT04163003|Behavioral|Targeted Approaches for Promoting Adolescent Sleep (TAPAS)|The targeted intervention is a three part sleep program, involving a 2- minute psychoeducation video, an in-person session with a clinician focusing on sleep, and web-based goal setting related to sleep behaviors. Intervention approaches to promoting adolescent sleep and reducing insufficient sleep use a motivational interviewing style, rooted in cognitive-behavioral strategies for improving sleep.
15835218|NCT04163003|Behavioral|Sleep Monitoring Only|Participants will monitor sleep with sleep diary, but they will not receive feedback or any other information on to sleep.
15835219|NCT04162990|Behavioral|Lifestyle remodeling Intervention|Participants will be received 2 phases of intervention of lifestyle remodeling, 3 months for each phase, which contained cognitive stimulating activities and physical activities.
15835220|NCT04162990|Behavioral|Does Comparator: regular treatment|Participants in this group would be treated as usual, which contained the healthy education.
15835221|NCT04162977|Behavioral|Personality-targeted Interventions|The Personality-targeted Interventions (i.e., Preventure programme) are selective substance use prevention programme designed to target known personality risk factors for substance misuse based on the evidence from cross-sectional and longitudinal studies which connect these personality risk factors to early initiation and escalation of substance misuse in adolescents. This selected personality-targeted approach targets four personality-specific motivational pathways to substance misuse: Hopelessness, Anxiety Sensitivity, Impulsivity, and Sensation Seeking. Each intervention will involve two 90-minute sessions, with an average of 6 personality-matched adolescents per group, and will be conducted using manuals that incorporate psycho-educational, motivational enhancement therapy (MET), and cognitive behavioural therapy (CBT) components and include real life 'scenarios' shared by high-risk local youth with similar personality profiles.
15835222|NCT04162964|Behavioral|Chair Yoga|8-week dyadic chair yoga program for one hour per week. Chair yoga is an effective way to offer modified yoga postures and relaxation techniques to individuals with limited mobility and/or advanced age for whom mat-based classes may not be accessible. The weekly yoga classes will be lead by a certified instructor and will include 4-10 participants (or 2-5 patient-caregiver dyads).
15835223|NCT04162951|Procedure|Ordinary approach paravertebral block|Ultrasound guided thoracic paravertebral block. At the appropriate dermatome, the needle (22-gauge, 8-10-cm, short bevelled spinal needle, or a Touhy needle if a catheter is to be placed) is inserted 2.5-3 cm lateral to the spinous process and advanced perpendicular to the skin in all planes to contact the transverse process at a variable depth (2-4 cm) depending on the build of the individual. The needle is then walked above the transverse process and gradually advanced until a loss of resistance to air or saline, or a subtle 'click' is felt as the superior costotransverse ligament is penetrated, usually within 1-1.5 cm from the superior edge of the transverse process.
15835224|NCT04162951|Procedure|Retrolaminar paravertebral block|In the retrolaminar approach to TPVB or retrolaminar block (RB), local anesthetic (LA) is injected into the retrolaminar plane to achieve a truncal sensory block like that of traditional TPVB. It has been postulated that during RB, LA spreads from the injection plane to the thoracic paravertebral space (TPVS) through the superior costotransverse ligament (SCTL). Retrolaminar block will be performed under ultrasound guidance, as a single injection.
15835225|NCT04162938|Other|Patient-Centered Electronic App|The coordinator will enter lab information to generate the patient's Fibrosis-4 score for liver fibrosis staging. With the information of liver fibrosis staging and survey responses, the app will generate individualized reports of the participant's comprehensive HCV disease progression, knowledge, and level of interest in receiving HCV care. The app will then deliver a streamlined, tailored, brief education message and include information regarding services and assistance for receiving HCV care.
15835226|NCT04162925|Behavioral|Cancer screening education for breast, colon and oral cancers|Bedside education one-on-one by showing screening video and handouts at the end of educational session for breast, colon and oral cancer. Patient who are agreeable to oral cancer screen during hospitalization perform oral cancer screening
15835227|NCT04162912|Behavioral|Motivational Interviewing tailored Advance Care Planning|The trained interventionist who is experienced in MI techniques will explore their illness experiences, emotions and beliefs about their health conditions and future care in an empathetic manner and explore their ambivalence for ACP behaviours.
15835228|NCT04162899|Drug|Drug: SHR0302|The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK-1(known as a JAK-1 inhibitor).
15835229|NCT04162886|Other|Exercise|Thrower's ten exercises will given for 8 weeks, 3 days in a week.
15835230|NCT04162873|Drug|Celecoxib|Given PO or via feeding tube
15835231|NCT04162873|Other|Placebo|Given PO or via feeding tube
15835232|NCT04162873|Other|Quality-of-Life Assessment|Ancillary studies
15835233|NCT04162873|Other|Questionnaire Administration|Ancillary studies
15835234|NCT04162860|Device|Eso-SPONGE® device|Preemptive ENP therapy will be carried out with either an Eso-SPONGE® device system (Eso-SPONGE®, B. Braun Melsungen AG, Melsungen, Germany). Eso-SPONGE® consists of an open-pored polyurethane foam fitted to a gastric tube. Secretions are then continuously evacuated using a suction pump generating a negative pressure between 75 and 100 mmHg.
15835235|NCT04162847|Device|SilverCloud Health Intervention|SilverCloud Health is a mobile mental health platform offering cognitive-behavioral therapy-based guided self-help programs for preventing and treating anxiety, depression, and eating disorders as appropriate Participants in this arm will receive the support of a coach to guide them through the program. Participants will be able to communicate with their coach within the program.
15835236|NCT04162834|Drug|Papaverine|Immediately after the renal artery declamping, papaverine 30 mg (1 ample, 1 ml) is mixed with 5 ml of normal saline (total 6 ml) and sprinkled around the renal artery.
15835237|NCT04162834|Drug|Normal saline|Immediately after the renal artery declamping, normal saline 6 ml is sprinkled around the renal artery.
15835238|NCT04162821|Drug|Hydronidone|Take hydroxynitone capsule
15835239|NCT04162795|Drug|Loratadine (Claritin, BAY76-2211)|Chewable tablet, oral, single dose
15835240|NCT04162782|Procedure|obstetric and gynaecological surgeries|surgeries for gynecologic and obstetric diseases
15835241|NCT04162769|Drug|Etrasimod|"Etrasimod Dose A tablet taken by mouth, once daily up to 12 weeks during the Double-Blind Treatment Period"
15835242|NCT04162769|Drug|Etrasimod|"Etrasimod Dose B tablet taken by mouth, once daily up to 12 weeks during the Double-Blind Treatment Period"
15835243|NCT04162769|Drug|Etrasimod matching placebo|Etrasimod matching placebo tablet by mouth, once daily up to 12 weeks during the Double-Blind Treatment Period
15835244|NCT04162769|Drug|Etrasimod|"Etrasimod Dose B tablet taken by mouth, once daily up to 52 weeks during the Open-Label Extension Period"
15835245|NCT04162756|Biological|Brexucabtagene Autoleucel (KTE-X19)|A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells/kg administered intravenously.
15835246|NCT04162756|Drug|Fludarabine|Administered per package insert
15835247|NCT04162756|Drug|Cyclophosphamide|Administered per package insert
15835248|NCT04162743|Drug|Trazodone|take trazodone 100mg before polysomnography
15835249|NCT04162743|Drug|Placebo oral tablet|take placebo oral tablet before polysomnography
15835250|NCT04162730|Other|Pressure pain threshold and behavioural data|Pressure pain threshold level of the knee region will be collected and behavioural data will be measured
15835251|NCT04162717|Behavioral|The Effect of Telephone Symptom Triage Protocols on Symptom Management, Quality of Life and Self-Care Maintenance in Patients with Cancer Who Applied Systemic Treatment|"Symptom management, quality of life and self-maintenance were assessed by scales at the first interview and 3 months later.
~Intervention group received symptom triage application with telephone, which consisted of guiding in line with symptom triage protocols. The patients who were included in the intervention were followed up by telephone on the 3rd, 7th and 10th day of after chemotherapy total of nine times during three chemotherapy cycles."
15835252|NCT04162704|Device|EpiCheck|If the EpiCheck test is positive at the time of inclusion, the test is repeated prior to the fourth and sixth instillation with Mitomycin as well as prior to the subsequent two cystoscopies. If the EpiCheck test is negative at the time of inclusion, no further tests will be performed.
15835253|NCT04162691|Diagnostic Test|Tissue|Four 4-5 mm tissues of the thymoma
15835254|NCT04162678|Procedure|Biospecimen Collection|Undergo collection of blood via HD-SCA fluid biopsy
15835255|NCT04162678|Other|Laboratory Biomarker Analysis|Correlative studies
15835256|NCT04162678|Procedure|Liquid Biopsy|Undergo collection of blood via HD-SCA fluid biopsy
15835257|NCT04162678|Other|Medical Chart Review|Review of medical chart
15835258|NCT04162665|Radiation|MR guided radiation therapy|-Image-based treatment planning and intensity modulated radiotherapy (IMRT) is permitted.
15835259|NCT04162665|Procedure|Blood for ctDNA|-Prior to start of radiation, after the completion of radiation therapy and prior to starting chemotherapy (2-4 weeks after radiation completion), at the completion of chemotherapy and prior to surgery (2-4 weeks after chemotherapy completion), and 6 months after surgery
15835260|NCT04162639|Biological|Skin allograft|Participants will receive skin allograft from either 1, 2 or 3 distinct cadavers. This skin allograft will be applied in a routine fashion, with no deviation from the typical clinical course of treatment.
15835261|NCT04162626|Other|Supportive home visits to new families|The new families are offered home visits by a public health nurse from 28 weeks in pregnancy until the child is two years old. The number of home visits depends on the families needs and wishes. They also get the usual follow up from the Child health center.
15835262|NCT04162626|Other|Treatment as usual|Follow up at the Child health center according to national regulations
15835263|NCT04162613|Other|Different measures of muscle function such as muscle strength, hop tests, postural orientation and muscle activation|"The participants will be assessed with a physical test battery at baseline including: Isokinetic knee strength, Isometric strength of trunk and lower extremity, Single-leg hop for distance, side hop, postural orientation (single leg-squat, stair descending, forward lunge, Single-leg hop for distance, side-hop), hip and ankle range of joint motion, muscular activation pattern, 3D movement analysis and proprioception test.
~At follow-up (2 years), the participants will be asked to answer a survey about new ACL injuries and return to sport/previous activity level."
15835264|NCT04162600|Biological|ChAdOx2 RabG|Single dose of ChAdOx2 RabG at different concentrations: 5 x 10^9 vp, 2.5 x 10^10 vp, 5 x 10^10 vp
15835265|NCT04162600|Biological|Inactivated Rabies Vaccine|A complete pre-exposure prophylactic course of an existing rabies vaccine, ≥2.5 international units
15835266|NCT04162587|Other|Carotid duplex+/- MRA neck|Carotid duplex and or MRA neck
15835267|NCT04162587|Other|brain MRA+/-CT angio on carotid and brain|brain MRA and or CT angiography on carotid and brain
15835268|NCT04162587|Other|MRI brain|MRI brain with diffusion to detect asymptomatic stroke
15835269|NCT04162587|Other|DSA (digital subtraction angiography)|DSA (digital subtraction angiography) in some cases to confirm diagnosis.
15835270|NCT04162574|Other|Recovery Record|Observational data will be obtained through participants entering data on disordered eating episodes, mood, and food in Recovery Record, an app to assist people in managing their eating disorder during the 30 days of the trial. In addition, participants wear an Apple Watch from which passive data (e.g., heart rate, activity, and geolocation) are collected.
15835271|NCT04162561|Behavioral|Patients with documented IHD|Assessment of patients' quality of life with the use of the Seattle Angina Questionnaire (SAQ), blood pressure levels (using the Korotkoff method, blood pressure is measured 3 times with 1-minute intervals on the hand with the higher blood pressure levels while sitting calm after a 5-minutes rest), laboratory methods (lipids, glycosylated hemoglobin levels), patients' adherence to treatment (original questionnaire), quality of patients' therapy taken at the time of visit, necessity of invasive coronary revascularization procedures (during all visits).
15835272|NCT04162535|Drug|Lidocaine 1% Injectable Solution|"Lidocaine 1% Injectable Solution Intervention Protocol for the TIVA and Lidocaine Arm
~Induction: 1.5 mg / kg i.v. bolus before induction (at the vein catch).
~Maintaining anesthesia: continuous infusion with Lidocaine 2 mg / kg / h, up to a maximum of 200 mg / h during maintenance (after IOT until waking)
~Infusion with 1% Lidocaine will be reduced to 1.0- 1.5 mg / kg / hour, max 100 mg / hour, for the first 48 hours postop"
15835273|NCT04162535|Biological|Blood extraction|The patients will donate after consent 10 ml of blood prior and after surgery for further study
15835381|NCT04161716|Device|NIRS recording|Patient has a NIRS module during their urodynamic exam.
15835274|NCT04162535|Drug|Sevoflurane|Patients will receive a general volatile anesthesia with Sevoflurane as anesthetic agent
15835275|NCT04162535|Drug|Propofol|Patients will receive a general anesthesia with Propofol as anesthetic agent
15835276|NCT04162522|Drug|Escitalopram|Participants are given escitalopram for 8 weeks. At week 8, those classified as responders will continue on escitalopram until the end of study.
15835277|NCT04162522|Drug|Brexpiprazole|Participants who are classified as non-responders are given 8 weeks add-on brexpiprazole, in addition to escitalopram, for the remainder of the study.
15835278|NCT04162509|Other|AR app|Participants will be exposed to nine different AR spider scenarios with a pre-defined length of 2 minutes for each level. Each level starts with a surface scan of the environment and the placement of the AR spider model(s) by tapping on the display. Through small text pop-ups the user is instructed to perform different tasks (e.g. looking at the spider model, approaching it, holding the hand under the model). They proceed to further levels according to a predefined exposure scheme based on SUDS for fear (scale 0=no fear to 10=maximum fear) and disgust (scale 0=no disgust to 10=maximum disgust) and the assurance of the task completed (yes/no). Users will repeat each level until their SUDS are 4 or below and have completed the task. Each exposure session is limited to approx. 30 minutes (controlled by the participants) irrespective of achieved level.
15835279|NCT04162496|Device|Restylane Refyne|Injection of Restylane Refyne with a cannula on one side of the neck and a 30 guage needle on the other side.
15835280|NCT04162483|Device|Neuroform Atlas Stent System|Stenting Assisted coiling procedure
15835281|NCT04162470|Drug|REGN3918|Subcutaneous (SC) every week (QW) over the treatment period
15835282|NCT04162457|Dietary Supplement|Stevia|Participants will be administered one of the study beverages at each one of the 4 imaging sessions.
15835283|NCT04162457|Dietary Supplement|Glucose|Participants will be administered one of the study beverages at each one of the 4 imaging sessions.
15835284|NCT04162457|Dietary Supplement|Maltodextrin|Participants will be administered one of the study beverages at each one of the 4 imaging sessions.
15835285|NCT04162457|Dietary Supplement|Water|Participants will be administered one of the study beverages at each one of the 4 imaging sessions.
15835286|NCT04162444|Diagnostic Test|Physical examination|A physical examination is a routine screening procedure used to investigate a patient's symptoms or complaints. It consists of a series of questions regarding patient medical history followed by an examination of the symptoms to determine the correct diagnosis and treatment plan.
15835287|NCT04162444|Diagnostic Test|The Ross Classification for Heart Failure in Children|The assessment is performed by pediatric cardiologist according to the classic Ross scale. One of the 4 classes of chronic heart failure is registered.
15835288|NCT04162444|Diagnostic Test|The Aristotle score|Surgical risks will be assessed by the ARISTOTLE score developed specially for the task. The calculation will be performed online, available from http://www.aristotleinstitute.org.
15835289|NCT04162444|Other|Assessment of administered specific therapy|"The data will be registered as groups of administered medicines:
~Antiplatelet agents
~Loop diuretics
~Potassium-sparing diuretics
~Angiotensin-converting enzyme inhibitors"
15835290|NCT04162444|Diagnostic Test|Multispiral computed tomography/3D echocardiography|"All patients enrolled in the study should be routinely examined with multispiral computed tomography (MS-CT) or 3D-echo before surgery and 3 years later. As a result, a 3D aortic root reconstruction will be made to assess its size and anatomy and subsequently build a 3D soft model for surgery imitation.
~At the study onset, we plan to perform MS-CT, then 3D-echo. If the correlation resulting from 3D-echo and the actual sizes will be high, the isolated 3D-echo will be preferred in the future.
~If none of the methods is available, the patients will not be enrolled in the study.
~The following data will be registered for further analysis:
~Perimeter of the aortic valve
~Diameter of the aortic valve at sinuses level
~Height of the aortic sinuses
~Morphology of the aortic valve"
15835291|NCT04162444|Diagnostic Test|Transthoracic and transesophageal echocardiography|"Transthoracic echocardiography is carried out at baseline, at discharge and then annually. It is performed in order to assess the contractile function of the heart and hemodynamic characteristics of the aortic valve and its autopericardium graft.
~Transesophageal echocardiography is carried out directly after the withdrawal of the artificial circulation when performing augmentation of the aortic valve with autopericardium in order to asses hemodynamic characteristics of the aortic neo-valve."
15835292|NCT04162444|Diagnostic Test|12-lead electrocardiogram|"Registering 12-lead electrocardiogram (ECG) is used as a tool for assessment of the regularity of the heart rhythm as well as screening and predictive tool for assessment of fibrosis and hypertrophy processes in the myocardium. The following data will be registered:
~Heart rate
~Sinus rhythm (yes/no)
~Positive R wave in leads V5-6
~Angle α less than 0
~Presence/absence of abnormal Q wave
~Presence/absence of ST-segment depression in precordial leads"
15835293|NCT04162431|Diagnostic Test|spectroscopic measurement|measurement of the tissue with spectroscopy
15835294|NCT04162431|Diagnostic Test|FNA biopsy|a fine needle aspiration (FNA) biopsy will be taken
15835295|NCT04162431|Diagnostic Test|histopathology and cytology|Histopathology and cytology will be performed on the samples
15835296|NCT04162418|Device|Temporary Spur Stent System|Treatment of qualifying infrapopliteal lesions with Temporary Spur Stent System and a commercially available, limus-base drug-coated balloon
15835297|NCT04162405|Behavioral|Tinnitus Handicap Inventory Test|A prospective cohort nonrandomized study of non-masked parallel paired groups. The data will be collected from an electronic database that is filled in during diagnostic processing. During the diagnostic processing, TSI and THI questionnaires will be filled in, a tone audiogram (TA) and DPOAE will be performed.
15835298|NCT04162392|Other|shared decision making|Patients can choose the intervention that they want. There are different physiotherapy interventions were the patients have to do physical activity during the hospital stay. The physiotherapist explains the advantages and disadvantages of each treatment before they choose.
15835299|NCT04162392|Other|control group|Patients receive a physiotherapy intervention but they do not have the opportunity to choose the treatment
15835335|NCT04162106|Device|Smoke management during laparoscopic cholecystectomy using the Ultravision™ System|The Ultravision™ System will be used during the procedure to manage smoke generated as a result of the use of diathermy.
15835336|NCT04162106|Device|Smoke management during laparoscopic cholecystectomy using the Airseal® iFS|The Airseal® iFS will be used during the procedure to manage smoke generated as a result of the use of diathermy.
15835300|NCT04162379|Drug|Oral tablet|Patients will be allocated as single group and will take oral prednisolone (sulopride10 mg) single dose every two days for 4 successive weeks then the next two weeks as washout period (stop dosing gradually by taking 5 mgs for 3 successive dosing every 2nd day over a week, then stop the oral steroid drug totally over the 2nd week of the washout period. The second period of the study will start by taking the oral prednisolone (sulopride10 mg) every fourth day for the next 4 weeks after which the patient will get another washout two weeks period (stop dosing gradually 5 mg for 3 successive dosing every 4th day then stop the drug totally).
15835301|NCT04162366|Drug|Aprocitentan 25 mg|Tablet, oral use once daily
15835302|NCT04162366|Drug|Placebo|Matching placebo tablet, oral use once daily
15835303|NCT04162353|Biological|BCMA-CD19 cCAR T cells|BCMA-CD19 cCAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy
15835304|NCT04162340|Biological|CD4 CAR T cells|CD4 CAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.
15835305|NCT04162327|Drug|IBI315|Patients will receive IBI315 until disease progression, intolerability, informed consent withdraw, or other reasons leading to treatment discontinue.
15835306|NCT04162327|Drug|IBI315|Patients will receive IBI315 RP2D until disease progression,intolerability, informed consent withdraw, or otherreasons leading to treatment discontinue.
15835307|NCT04162314|Drug|Beta-1,3/1,6-D-Glucan Ganoderma lucidum|Beta-1,3/1,6-D-Glucan capsule three times daily for 90 days
15835308|NCT04162314|Drug|Placebos|Placebos
15835309|NCT04162301|Drug|CS3002|CS3002 tablet will be orally administered daily for 3 weeks followed by 1 week off treatment, defining a treatment cycle of 28 days in duration.
15835310|NCT04162288|Other|Online Training - Shared Decision Making in Prenatal Screening|TThe intervention consisted of an online self-study training program lasting 3 hours which aims to engage SDM in a prenatal screening context. The training was divided into four main modules: 1)SDM, 2)DS prenatal screening, 3)Decision aid and 4)Communication between healthcare professionals and patients. In each module, the targeted learning objectives and the work to be carried out (e.g. readings to be made, video to be viewed, evaluation to be carried out, etc.) are presented. Various teaching methods and medias are used during this training: videos, interviews, narrated capsule, readings, links to scientific articles and complementary websites. Videos are done with experts on SDM, ethics of prenatal testing. A simulation in the end is done to put participants in context of an actual consultation with a pregnant woman and her partner. This training was designed to adapt to the learning pace of the user, is hosted on University Laval platform and needs an identification code to enter.
15835311|NCT04162288|Other|Online Training - Online Training on Prenatal Screening|The control intervention consisted of an online self-study training program lasting 3 hours which aims to provides knowledge for prenatal screening. The training has four main modules: 1)Context and history of prenatal screening(new), 2)DS prenatal screening(existing), 3)Consent in prenatal screening(new) and 4)Communication between healthcare professionals and patients(existing). In each module, the targeted learning objectives and the work to be carried out are presented. Various teaching methods and medias are used during this training: videos, interviews, narrated capsule, readings, links to scientific articles and complementary websites. Videos are done with experts on SDM, ethics of prenatal testing. For the 2 new modules, narrated capsules and reports have replaced videos of experts. There is no simulation at the end. This training was designed to adapt to the learning pace of the user, is hosted on University Laval platform and needs an identification code to enter.
15835312|NCT04162275|Drug|Finamine tablets|taken Finamine tablets orally
15835313|NCT04162275|Drug|Placebo tablets|taken Placebo tablets orally
15835314|NCT04162262|Other|Instrumental-assisted soft tissue mobilization (IASTM)|Instrumental-assisted soft tissue mobilization (IASTM) will consist of treatment focused on the plantar surfaces of foot, posterior heel, and lower leg. The IASTM will be implemented using Graston Technique Instruments by clinicians trained and certified in the technique. Each 10-minute treatment will consist of two phases: 1) six-minute static phase, which includes tissue status screening and soft tissue mobilization, and 2) four-minute dynamic tissue mobilization phase. The treatment will focus on the web spaces of each toe plantarly, the metatarsal heads, the spaces between metatarsals, the medial and lateral plantar fascia borders, plantar fascia proximal origin, the heel, and the lower leg muscle groups. The targeted soft tissues are the plantar fascia, ankle plantar flexors, heel fat pad, Achilles tendon, and the gastrocnemius-soleus complex.
15835315|NCT04162262|Other|High-Load Strength Training|Participants will perform a heel raise exercise used by Rathleff et al (2015). The exercise will be performed twice daily. While standing with the forefoot on a step, the toes will rest on a partially folded towel, placing them in a maximally dorsiflexed position. The exercise will consist of a maximum ankle plantar flexion followed by maximal dorsiflexion. The concentric plantar flexion and eccentric lowering phases will be 3 seconds, with a 2 second isometric pause in between. The exercise will be performed unilaterally if tolerated by the subject. Otherwise, a bilateral calf raise will be performed until the subject is able to perform the unilateral version. The exercise will be performed every other day and progressed throughout the trial as described by Rathleff and colleagues.
15835316|NCT04162262|Other|Plantar Flexor and Gastrocnemius Stretching|For the plantar flexor stretch (DiGiovanni et al, 2006), subjects will sit and cross the affected leg over the contralateral leg. Placing the affected side fingers on the plantar toes, distal to the metatarsophalangeal joints, they will passively dorsiflex the toes until they feel stretching in the arch of the foot. Subjects will be instructed to hold this stretch for 10 seconds and repeat it 10 times. The gastrocnemius stretch will be performed in supine with a towel placed around the distal foot and the foot actively inverted. With the knee extended, the subject will flex the hip while passively dorsiflexing the foot using the towel. This stretch will be held for 30 seconds and repeated 3 times. Subjects will be asked to perform both stretches three times each day.
15835317|NCT04162249|Other|Conventional LSI/AI-guided pulmonary veins ablation.|Conventional (low-power and long-duration) radiofrequency application.
15835318|NCT04162249|Other|High-power pulmonary veins ablation.|Experimental (high-power and short-duration) radiofrequency application.
15835319|NCT04162249|Other|Esophageal temperature monitoring|Two probes were simultaneously used: a deflectable one and a non-deflectable one.
15835320|NCT04162249|Diagnostic Test|Esophageal endoscopy|Esophageal endoscopy for acute detection of esophageal thermal lesions <72 hours after ablation.
15835321|NCT04162236|Diagnostic Test|Ecocardiographyc ultrasound|"Epidemiological data: Maternal history risk factors. First trimester scan is performed on all patients.
~Antropomethric measures
~Systemic arterial stiffness: using applanation tonometry with pulse wave analysis and pulse wave velocity.
~Carotid Intima Thickness
~Echocardiography assessment: It will be performed by a cardiologist specialized in cardiac imaging according to the usual standard protocol. High resolution images will be acquired and post-processed with dedicated software for the speckle tracking analysis. 2D echocardiography parameters to be acquired, tissue Doppler and speckle tracking software
~Markers in maternal blood: Angiogenic factor and cardiac function biomarkers: Blood samples will be collected without anticoagulant to obtain serum. sFLT-1, PlGF, High-sensitivity Troponin and NT-proBNP will be measured using automated electrochemiluminescence immunoassays."
15835322|NCT04162223|Biological|Subcutaneous fat injection of Recombivax-HB|Subcutaneous fat injection administration of licensed Hepatitis B Surface Antigen Vaccine (Recombivax-HB) on Days 0, 28, and 180.
15835323|NCT04162223|Biological|Intramuscular injection of Recombivax-HB|Intramuscular injection administration of licensed Hepatitis B Surface Antigen Vaccine (Recombivax-HB) on Days 0, 28, and 180.
15835324|NCT04162210|Drug|Belantamab mafodotin|Belantamab mafodotin will be available as powder for solution for infusion which will be administered via intravenous (IV) route. Belantamab mafodotin will be reconstituted for injection 100 mg/vial with 2.0 milliliter (mL) of water for injection with dose level of 2.5 mg/kg.
15835325|NCT04162210|Drug|Pom/dex (Pomalidomide plus low dose Dexamethasone)|Pomalidomide will available as capsule and Dexamethasone will be available as tablet which will be administered via oral route.
15835326|NCT04162197|Device|GEO|Robot-Assisted Gait Training (RAGT) The Robotic Group (RG) performs a Robot-Assisted Gait Training (RAGT) using an end-effector robotic device (G-EO system-Reha Technology-Olten, Switzerland).
15835327|NCT04162197|Device|GEO and HUNOVA|Robot-Assisted Gait Training (RAGT) and Balance Training. The Balance Group (GHG) performs a Robot-Assisted Gait Training (RAGT) using an end-effector robotic device (G-EO system-Reha Technology-Olten, Switzerland) and a Balance training using a robotic proprioceptive platform (Hunova - Movendo Technology, Italy).
15835328|NCT04162184|Behavioral|Sexual Health Initiative for Navigation and Education (SHINE) Health Educator Intervention|a brief health educator-led behavioral intervention focused on educating, identifying reproductive health needs, and linking to services if desired
15835329|NCT04162171|Radiation|Stereotactic Body Radiotherapy (SBRT) ablation of VT|"Additional imaging for SBRT planning and implementation:
~Planning CT (pCT) - CT simulator that utilizes a respiratory positioning monitoring (RPM) optical tracking system and SBRT immobilization setup to provide necessary data to allow for monitoring of the patient's deep inspiration breath-hold (DIGH) maneuver during treatment delivery.
~SBRT treatment - 30 min procedure on a TrueBeam 1 linear accelerator using SBRT fixation. Patient alignment and DIBH maneuver from the pCT will be replicated using the on-board cone-beam CT (CBCT) guidance and RPM systems."
15835330|NCT04162158|Biological|allogeneic NK cells therapy|PBMC was isolated from the peripheral blood of the donors and infused to the patient after 14 days incubation. In each cycle, patients will be infused 4.0-5.0×10'9 allogeneic NK cells. All patients in the experimental group received a total of three cycles of treatment with one month interval between each treatment.
15835331|NCT04162145|Device|Active BRIDGE device placement|The active BRIDGE device will be placed by a blinded medical provider. The severity of opioid withdrawal signs and symptoms will be assessed with the COWS, pain and cognitive functioning tests at several time points. Patients will be dosed with buprenorphine at the blinded provider's discretion. Supportive medications to help manage signs and symptoms of opioid withdrawal will NOT be allowed for one hour after the first dose of buprenorphine. Subjects will be asked to return to clinic for additional visits based on the clinic standard of care. Subjects will be reassessed using COWS, OCS and VAS at each subsequent visit, or remotely (via phone) when unrequired to return to clinic during the 5-day trial. The device will be removed at the clinic visit on Day 5 and disposed of in a sharps container. If the patient cannot come back on day 5, they will be instructed to remove the device at home and bring it back at the next clinic appointment for proper disposal.
15835332|NCT04162145|Device|Inactive BRIDGE device placement|The inactive or sham BRIDGE device will be placed by a blinded medical provider. The severity of opioid withdrawal signs and symptoms will be assessed with the COWS, pain and cognitive functioning tests at several time points. Patients will be dosed with buprenorphine at the blinded provider's discretion. Supportive medications to help manage signs and symptoms of opioid withdrawal will NOT be allowed for one hour after the first dose of buprenorphine. Subjects will be asked to return to clinic for additional visits based on the clinic standard of care. Subjects will be reassessed using COWS, OCS and VAS at each subsequent visit, or remotely (via phone) when unrequired to return to clinic during the 5-day trial. The device will be removed at the clinic visit on Day 5 and disposed of in a sharps container. If the patient cannot come back on day 5, they will be instructed to remove the device at home and bring it back at the next clinic appointment for proper disposal.
15835333|NCT04162132|Device|Smartphone app|Study procedures related to the DynamiCare Rewards intervention were conducted via smartphone. Research visits included collection of urine samples and medical exams. Participants assigned to the DynamiCare Rewards group received: 1) the app on their smartphone, 2) drug testing devices when indicated (pocket-sized breathalyzer), and a reloadable debit card for receiving the financial incentives (the PEX debit card). Global Positioning System (GPS) tracking was used to track whether patients had attended their scheduled appointments but was not used at any other times. All information was uploaded from the app onto the DynamiCare Analytics website, which treatment providers could view. The information reported was: attendance status of appointments, the status of all alcohol and drug testing, and incentives earned. Each patient's intervention period (period of time when they used the app) lasted four months from the date of their enrollment.
15835334|NCT04162119|Biological|BCMA-PD1-CART Cell|This study was a single-center, open-label, single-arm, non-randomized clinical trial, which was divided into 3 groups by infusion dose level. Firstly, each dose group has 3 patients. The pretreatment regimen of cyclophosphamide (25mg/m2 for 3 consecutive days) and fludarabine (10mg/kg for 3 consecutive days) was given before CART cells were reinfused. CART cells were reinfused on the third day after the pretreatment. If no serious side effects emerges in the group, then the next group uses the subsequent higher dose. If serious side effects emerges in a single patient in any dose level, 3 more patients will be enrolled to the same dose level. After 9 or more patients, we select the safest dose and recruit more patients for CART test to explore its effectiveness.
15835338|NCT04162054|Other|Observational study to evaluate acute cardiopulmonary effects of whole body vibration (WBV) on healthy individuals analysed in non-invasive cardiopulmonary exercise test (CPX).|Observational study to evaluate acute cardiopulmonary effects of whole body vibration (WBV) on healthy individuals analysed in non-invasive cardiopulmonary exercise test (CPX).
15835339|NCT04162028|Drug|Nebutlized Ketamine|The PK-BAN package will be opened and weight -based dose of ketamine will be administered to the patient via BAN. The medication will be delivered with a minimum time of 5 min and maximum time of 15 min.
15835340|NCT04162015|Drug|Nivolumab|nivolumab 360 mg
15835341|NCT04162015|Drug|Pemetrexed|500 mg/m^2
15835342|NCT04162015|Drug|Cisplatin or Carboplatin|cisplatin 75 mg/m2 or carboplatin AUC=5
15835343|NCT04162002|Drug|Restylane® Lyft|Filler Injection
15835344|NCT04161989|Drug|omega-3 fatty acids|. The Omega 3 plus capsule contains 1000 mg Fish Oil (contains Eicosapentaenoic acid 13% & Docosahexaenoic acid 9%) plus 100 mg Wheat Germ Oil (Linoleic acid 52- 59%) as a natural source of Vitamin E.
15835345|NCT04161989|Drug|vaginal progesterone|Prontogest 400 mg vaginal suppository contains progesterone 400 mg.
15835346|NCT04161976|Drug|LY900027|LY900027 administered to participants with T1DM using CSII.
15835347|NCT04161976|Drug|Insulin Lispro|Insulin lispro administered to participants with T1DM using CSII.
15835348|NCT04161963|Device|SD-OCT|Optical Coherence Tomography of the maculy with Heidelberg Spectralis SD-OCT
15835349|NCT04161963|Device|OCT-A|swept source Optical Coherence Tomography Angiography with Zeiss Plex Elite 9000 of the macula
15835350|NCT04161950|Other|Assessment of the safety and validity of echoendoscope|"Ultrasonic and endoscopic image quality assessment
~Device controllability assessment
~System safety assessment
~System stability assessment"
15835351|NCT04161937|Behavioral|Behavioural Intervention|Behavior intervention will comprise of combination of intensive education session, group counseling, goal setting and monitoring based on the Diabetes Prevention Program (DPP).The curriculum includes 24 sessions: 16 core sessions weekly during the first four months of the program followed by a monthly maintenance sessions.
15835352|NCT04161924|Diagnostic Test|X-ray imaging with physical grid using conventional processing|X-ray imaging with physical grid using conventional processing
15835353|NCT04161924|Diagnostic Test|X-ray imaging without physical grid using conventional processing|X-ray imaging without physical grid using conventional processing
15835354|NCT04161924|Diagnostic Test|X-ray imaging without physical grid using experimental SimGrid offline processing|X-ray imaging without physical grid using experimental SimGrid offline processing
15835355|NCT04161898|Drug|Upadacitinib|Upadacitinib will be administered as oral tablet
15835356|NCT04161898|Drug|Placebo for Upadacitinib|Placebo for upadacitinib will be administered as oral tablet
15835357|NCT04161898|Drug|Prednisolone|Prednisolone will be administered as oral tablet
15835361|NCT04161872|Drug|Uricemin|Uricemin is a nutraceutical containing quercetin, rutin, bromelain and L-carnosine
15835362|NCT04161872|Drug|Placebo|Placebo
15835363|NCT04161859|Dietary Supplement|Nutraceutical|Nutraceutical with action on glycemia, dsylipidemia or hypertension will be considered.
15835364|NCT04161846|Behavioral|Virtual Training|The intervention involves a CHW training focused on raising awareness of diabetes prevention in the community. It is delivered remotely over 10 weeks using an internet based approach.
15835365|NCT04161846|Behavioral|In Person Training|The intervention involves a CHW training focused on raising awareness of diabetes prevention in the community. It is delivered in person over 10 weeks.
15835366|NCT04161833|Dietary Supplement|OPERA|All patients were required to take an OPERA® capsule (dietary supplement where α-lipoic acid, Boswellia Serrata, methylsulfonylmethane and bromelain are combined in a single capsule) once daily,from enrollment up to sixth months.
15835367|NCT04161820|Behavioral|The effect of education and telephone follow ups based on the Chronic Care Model on self-management, quality of life and patient satisfaction in patients with ischemic stroke|The effect of education and telephone follow ups based on the Chronic Care Model on self-management, quality of life and patient satisfaction in patients with ischemic stroke Self-management, quality of life and patient satisfaction were assessed by scales at the first interview and 3 months later. Metabolic variables of the patients were obtained from the patient clinical information system at the first interview and 3 months later.
15835368|NCT04161807|Device|Nerivio|The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application.
15835369|NCT04161794|Other|multimodal|2 g EPA/DHA as fish oil, repeated dietary counselling and twice weekly 2 x exercises
15835370|NCT04161781|Drug|18F-BMS-986229 Injection|Single injection prior to scan
15835371|NCT04161781|Drug|IV 18F-BMS-986229|370 MBq administered intravenously prior to scan
15835372|NCT04161781|Diagnostic Test|PET/CT Scan|Whole-body PET/CT (80 mA)
15835373|NCT04161768|Drug|Norfloxacin|Norfloxacin 400 mg daily
15835374|NCT04161768|Drug|Itopride|Itopride 50 mg three times daily
15835375|NCT04161755|Drug|Atezolizumab|Atezolizumab will be administered 6 weeks post-tumor resection (+/- 2 weeks)
15835376|NCT04161755|Biological|RO7198457|RO7198457 will be administered 9 weeks post-tumor resection (+/- 2 weeks)
15835377|NCT04161755|Drug|mFOLFIRINOX|mFOLFIRINOX regimen will be administered 21 weeks post-tumor resection (+/- 2 weeks)
15835378|NCT04161742|Device|Nevisense|Nevisense measures electrical impedance of skin lesions and provides an output called the electrical impedance spectroscopy (EIS) score
15835379|NCT04161729|Drug|Magnesium Sulfate|Intravenous magnesium sulfate 20 mg/kg in 100ml isotonic saline 0.9% over a 15-min period before induction of anesthesia and 20 mg/kg/h by continuous i.v. infusion until surgery completion.
15835380|NCT04161729|Drug|Isotonic saline 0.9%|Isotonic saline 0.9% 100ml over a 15-min period before induction of anesthesia and thereafter continuous i.v. infusion until surgery completion in dosage identical to magnesium sulfate group.
15835382|NCT04161703|Procedure|focused ultrasound, diet and exercise|"Focused Ultra Sound using a device of Mabel6 DUO Ultra Cavitation Technology produced by DAEYANG MEDICAL CO., KOREA applied on the abdominal region which extending bilaterally from the line extending from mid-axilla to iliac crest, and above from center of diaphragm to the line extending between two iliac crests below.
~an aerobic exercise 3 to5 times/week for 12 weeks in the form of walking on treadmill for 30 minutes with moderate intensity a weight maintenance diet, which ranged from 1700 kcal to 2200 kcal/day, which was calculated in an individual basis for each subject according to his BMR, throughout the study period (12 weeks) to ensure that the reduction in the circumference was due to the treatment intervention rather than due to their weight reduction"
15835383|NCT04161703|Procedure|diet and exercise|weight maintenance diet, which ranged from 1700 kcal to 2200 kcal/day, which was calculated in an individual basis for each subject according to his BMR, throughout the study period (12 weeks) to ensure that the reduction in the circumference was due to the treatment intervention rather than due to their weight reduction. All subjects in both groups (A & B) followed an aerobic exercise 3 to5 times/week for 12 weeks in the form of walking on treadmill for 30 minutes with moderate intensity (moderate intensity = 12-14 according to Borg Scale). The beginning period will be 15 mints and increased gradually until reaching 30 mints per time.
15835384|NCT04161690|Drug|Dexketoprofen Trometamol|intravenous dexketoprofen 50mg or intrathecal
15835385|NCT04161690|Drug|Ropivacaine Hydrochloride 7.5 MG/ML|Local Infiltration Analgesia
15835386|NCT04161664|Drug|Paclitaxel and Carboplatin|6 courses of Paclitaxel 175 mg/m2 and Carboplatin AUC 5 in a 3 weekly schedule
15835387|NCT04161651|Device|eversense|eversense CGM
15835388|NCT04161638|Behavioral|Stigma Video Exposure|The participants watched a 10 minute video on a computer screen that consisted of brief clips from popular television shows that depicted women with overweight and obesity and evoked negative weight-based stereotypes (e.g., clumsy, loud, and lazy). Both the high blood pressure and normal blood pressure arms participated in this intervention.
15835389|NCT04161638|Behavioral|Neutral video exposure|The participants watched a 10 minute video on a computer screen that consisted of a series of clips depicting neutral scenes (e.g., insurance commercials). Both the high blood pressure and normal blood pressure arms participated in this intervention.
15835390|NCT04161625|Behavioral|Digital exercise program with support|"The Safe Step application includes an instruction movie on how to create and progress an individual exercise program. The exercises, presented in video format, are organized into 10 groups with a main focus on balance (3 groups), lower-limb strength (4 groups), and gait/step (3 groups). The participants choose an exercise suitable for their needs from each group to compose a program of ten exercises.
~Participants use the app to plan their exercises, set reminders, register their exercise, and view statistics. A virtual physiotherapist delivers motivational messages and feed-back. At the end of each month the participants receive an email asking them to report any falls during the past month in a short digital survey. These messages also contains a new video with general falls prevention information.
~Technical support will be provided weekly at senior meeting sites. Try-out group exercises (step 1-3) will be provided by a local wellness association (Friskis&Svettis)"
15835391|NCT04161612|Other|Demographic characteristics, duration of spinal cord injury, spinal cord injurylevel, etiology, number of intermittent bladder catheterization (IC), number of night time|Observational clinical study
15835392|NCT04161599|Drug|Cefuroxime (750mg) I.V|Extra dosage
15835393|NCT04161599|Procedure|Colonic Surgery|Colonic Surgery
15835394|NCT04161599|Drug|Cefuroxime 750mg oral|Oral prophylaxis
15835395|NCT04161599|Drug|Metronidazole 250 MG Oral Tablet [Flagyl]|Oral prophylaxis
15835396|NCT04161599|Drug|Metronidazole 1 g Intravenous|IV prophylaxis
15835397|NCT04161599|Drug|Cefuroxime 1,5 g Intravenous|IV prophylaxis
15835398|NCT04161599|Drug|Sodium picosulfate, light magnesium oxide, anhydrous citric acid 10 mg/3.5 g/10.97 g Oral|Laxative for bowel cleansing
15835399|NCT04161586|Drug|Prilocaine Hydrochloride|Spinal Prilocaine for Ambulatory Surgery
15835400|NCT04161573|Behavioral|Watching ironic stories|All the participants would be asked to watch a series of self-made stories which are figurative or literal. They have to figure out what is the real meaning of the character's statement. The whole procedure will be done with a computer.
15835401|NCT04161560|Drug|Cetuximab-IRDye800|does of Cetuximab-IRDye800
15835402|NCT04161547|Drug|CSPCHA115 100 mg; Matching placebo 100 mg|CSPCHA115 100 mg once daily in the fasted state for 7 days; Matching placebo 100 mg once daily in the fasted state for 7 days.
15835403|NCT04161547|Drug|CSPCHA115 200 mg; Matching placebo 200 mg|CSPCHA115 200 mg once daily in the fasted state for 7 days; Matching placebo 200 mg once daily in the fasted state for 7 days.
15835404|NCT04161547|Drug|CSPCHA115 400 mg; Matching placebo 400 mg|CSPCHA115 400 mg once daily in the fasted state for 7 days; Matching placebo 400 mg once daily in the fasted state for 7 days.
15835405|NCT04161547|Drug|CSPCHA115 600 mg; Matching placebo 600 mg|CSPCHA115 600 mg once daily in the fasted state for 7 days; Matching placebo 600 mg once daily in the fasted state for 7 days.
15835408|NCT04161521|Procedure|Novel Technique of Placenta Accreta in Menoufia University Hospital|"Classical CS to decrease haemorrhage from placental bed.
~Delievery of the fetus.
~At the delivery 10 UI of oxytocin IV will be injected.
~The placenta is not attempted to be delievered.
~Opening of the broad ligament via round ligament division and ligation.
~Gentle dissection of the urinary bladder from lateral to medial.
~Bilateral uterine artery clamping at low level below the placental bed .
~Gentle attempt to deliver The placenta.
~If the placenta is delievered we will do bilateral uterine artery ligation at multiple levels and multiple square compression sutures(if needed) for proper hemeostasis at the placental bed. Then closure of uterine incision.
~If the placenta is not delievered we will do segmental ressection of lower uterine segment including the placenta .
~Intraperitoneal drain insertion."
15835409|NCT04161508|Drug|Sugammadex Injection|injection of sugammadex for the reversal of neuromuscular blockade at the end of the surgery
15835410|NCT04161508|Drug|Neostigmine Injection|injection of neostigmine for the reversal of neuromuscular blockade at the end of the surgery
15835411|NCT04161495|Drug|efanesoctocog alfa (BIVV001)|Pharmaceutical form:solution for injection Route of administration: intravenous injection
15835412|NCT04161482|Drug|Furosemide 80 mg (8 mg/mL)|Furoscix will be administered as a subcutaneous infusion.
15835413|NCT04161469|Procedure|Laser closure of the anal fistula tract (FiLaC)|The FiLaC procedure was performed using a ceramic diode laser platform (12 watts, 1470-nm wavelength). The laser fiber was introduced into the fistula tract via the external orifice using the seldinger maneuver until the internal orifice was found. The fiber delivered laser energy homogenously at 3600, causing shrinkage of the fistula tract around the fiber while it was withdrawn at the speed of 1 mm/s
15835414|NCT04161469|Procedure|Internal orifice closure|Closure of internal orifice with a purse-string suture using 2-0 polyglactin suture material.
15835415|NCT04161456|Drug|Apremilast|Apremilast twice daily 30 mg
15835416|NCT04161443|Other|physiotherapy|"Treatment will be performed three sessions per week for 4 weeks with postural advice and home exercise program with daily record of home diary.
~The selected outcome measures will be taken on initial visit (pre intervention), session 6 and final session 12 (post intervention)."
15835417|NCT04161430|Drug|DBPR108; Placebo matching sitagliptin|"Phase A (Weeks 1-24): DBPR108 100 mg once daily under fasted conditions for 24 weeks; Placebo matching sitagliptin 100 mg once daily under fasted conditions for 24 weeks.
~Phase B (Weeks 25-52): Drug: DBPR108 100 mg once daily under fasted conditions for 28 weeks."
15835418|NCT04161430|Drug|Placebo matching DBPR108; Sitagliptin; DBPR108|"Phase A (Weeks 1-24): Placebo matching DBPR108 100mg once daily under fasted conditions for 24 weeks; Sitagliptin 100 mg once daily under fasted conditions for 24 weeks.
~Phase B (Weeks 25-52): Drug: DBPR108 100 mg once daily under fasted conditions for 28 weeks."
15835419|NCT04161430|Drug|Placebo matching DBPR108; Placebo matching sitagliptin; DBPR108|"Phase A (Weeks 1-24): Placebo matching DBPR108 100 mg once daily under fasted conditions for 24 weeks; Placebo matching sitagliptin 100 mg once daily under fasted conditions for 24 weeks.
~Phase B (Weeks 25-52): Drug: DBPR108 100 mg once daily under fasted conditions for 28 weeks."
15835420|NCT04161417|Other|Patients with suspected or confirmed pancreatic cancer will be be asked to provide biopsy material for molecular profiling|Patients with suspected or confirmed pancreatic cancer will be be asked to provide biopsy material for molecular profiling. This will enable patient enrolment into a currently available PRIMUS study
15835421|NCT04161404|Drug|Brand name: Andrographis paniculata (Shine Hempedu Bumi) 1000mg capsules|Andrographis paniculata or hempedu bumi capsule is a traditional medicinal product registered under Ministry of Health Malaysia for general wealth being. It is traditionally used for anti-diabetic, anti-bacterial, anti-pyretic, anti-malarial, anti-inflammatory, antidiarrhoeal and other effects.
15835422|NCT04161404|Drug|Brand name: Andrographis paniculata (Shine Hempedu Bumi) 2000mg|Andrographis paniculata or hempedu bumi capsule is a traditional medicinal product registered under Ministry of Health Malaysia for general wealth being. It is traditionally used for anti-diabetic, anti-bacterial, anti-pyretic, anti-malarial, anti-inflammatory, antidiarrhoeal and other effects.
15835423|NCT04161404|Drug|Metformin (Glucophage) 1000mg|Metformin is an oral glucose-lowering drug of the biguanides class. Drug: Period 1 Subjects
15835424|NCT04161391|Drug|TPX-0046|Oral TPX-0046 capsules
15835425|NCT04161378|Diagnostic Test|Cardiac imaging|"Transthoracic echocardiography
~Late gadolinium enhancement CMR"
15835426|NCT04161378|Diagnostic Test|Laboratory analysis|"complete blood count
~biochemistry
~hs-CRP, MMPs, IL6, NT-pro-BNP"
15835427|NCT04161365|Procedure|Direct visual urethrotomy|Urethral stricture is treated with urethrotomy under visual control
15835428|NCT04161365|Procedure|Autologous fat grafting|Autologous fat graft is gathered and injected to stricture
15835429|NCT04161339|Drug|Hydroxychloroquine|400mg/daily of hydroxychloroquine for 8 weeks
15835430|NCT04161339|Drug|Placebo oral tablet|Amido pills/daily for 8 weeks
15835431|NCT04161313|Other|Measurement of functional capacity|Functional capacity of participants will be measured with six-minute walk test.
15835432|NCT04161313|Other|pulmonary function test|It will be measured using basic spirometry and presented lung volume parameters such as FEV1,FVC,FEV1/FVC,PEF, FEF25-75
15835433|NCT04161313|Other|Functional capacity|Functional capacity of participants will be measured with six-minute walk test and sit-to-stand test
15835434|NCT04161313|Other|Peripheral muscle strength|Isometric M. Quadriceps strength will be measured using electronic hand held dynamometer in sitting position.
15835435|NCT04161313|Other|Respiratory muscle strength|Inspiratory and expiratory muscle strength has been assessed by maximal inspiratory and expiratory mouth pressures.
15835436|NCT04161300|Other|Foam Rolling (FR)|FR auto-massage will place the foam roller between their ischial tuberosity and a hard surface (i.e., the floor) with their legs held in an extended position, keeping their ankles relaxed and oriented upward. For FR in the lumbar region, participants use their weight to slide the FR through the erector of the lumbar and thoracic spine. The total approximate duration will be about 10-15 minutes.
15835437|NCT04161300|Other|Control Group (CG)|The CG did not receive any intervention.
15835438|NCT04161300|Other|Orthopaedic Manual Physical Therapy Group (OMPT)|Based on the protocol used by Espí-López et al.: a) Unspecific and bilateral lumbar thrust (L5-S1), one of each side were performed; b) Hip joint decompression, performing 25 repetitions c) Hip rotator stretch with hip and knee flexion, 15 repetitions; d) Femorotibial decompression, 25 reps. e) Quadriceps femoral muscle compression and traction, 25 repetitions; f) Opening of the internal and external femorotibial interline, 15 repetition; g) Ankle decompression, 3 repetitions; h) Posteroanterior and anteroposterior mobilization of head and base of fibula, 25 repetitions. The total duration will be approximately 10-15 minutes.
15835439|NCT04161287|Procedure|transcatheter arterial chemoembolization|The hepatocellular carcinoma patients (≤5cm）who received SBRT are devided into two groups: with TACE and SBRT alone.
15835440|NCT04161274|Procedure|Traditional method: Electrosurgery|"The patient will be prepared before this technique by removing all metal objects in his possession. The area should be disinfected with a local antiseptic, leaving the area aseptic. Afterwards, perilesional infiltrated local anaesthesia (subcutaneous or intradermal) will be applied. Once the area has been anaesthetised, excision is made with scissors cutting through the most proximal part of the skin tag pendulum and the lesion is coagulated with the handle or knife of the electrocoagulator (previously regulated with the intensity in coagulation mode). The resulting abrasion will form an eschar that will be disinfected with povidone-iodine, and a protective dressing of sterile occlusive gauze bandage will be placed.
~Indications to the patient: the project participant will be instructed to dry the area with povidone-iodine antiseptic and not to expose the area to extreme humidity or sunlight."
15835441|NCT04161274|Procedure|Traditional method: Cryotherapy|The patient should be prepared: the area should be disinfected with a local antiseptic, leaving the area aseptic. for a few minutes the tip of an Adson forceps will be introduced in a container with liquid nitrogen until freezing. It will then be applied to the most proximal part of the skin tag pendulum until it is observed that the frostbite has reached the base of the lesion and the surface becomes whitish, with a halo of 1-3 mm. When this happens, it will be excise above the frost part in the pendulum. After application, it is disinfected with povidone- iodine and covered with a protective dressing of sterile occlusive gauze plaster. It will then form an eschar. Indications to the patient: the project participant will be instructed to dry the area with povidone-iodine antiseptic and not to expose the area to extreme humidity or sunlight.
15835442|NCT04161274|Procedure|Traditional method: Silver nitrate|"The patient should be prepared: the area should be disinfected with a local antiseptic, leaving the area aseptic. Excision will be made with scissors of the skin tag cutting through the most proximal part of the skin tag pendulum, then cauterized with the tip of the silver nitrate rod, trying not to apply in the perilesional zone.
~The resulting abrasion will form an eschar that will be disinfected with povidone-iodine, and a protective dressing of sterile occlusive gauze bandage will be placed.
~Indications to the patient: the project participant will be instructed to dry the area with povidone-iodine antiseptic and not to expose the area to extreme humidity or solar rays."
15835443|NCT04161274|Procedure|Moist healing environment method|The patient should be prepared: the area should be disinfected with a local antiseptic, leaving the area aseptic. Excision will be made with scissors of the skin tag by cutting through the most proximal part of the pendulum of the skin tag, later it will be disinfected with chlorhexidine and thin hydrocolloid dressing will be placed. Indications to the patient: the project participant will be told not to touch the dressing until the next control after 3 days with the research team. In case of incidents with the dressing (fall of the dressing), the patient will be given a replacement dressing for this purpose and be able to restore it immediately. It is recommended not to expose the area to the solar rays
15835444|NCT04161261|Procedure|Electrical Stimulation|To measure the facial nerve stimulation threshold for one mid-array and one apical electrode of the implant using the pulse-train stimuli
15835445|NCT04161248|Drug|Venetoclax|"Dose Level -1: Venetoclax 200 mg/day days 4-8 cycle 1, days 1-5 cycle 2 and 3, + R-GDP
~Dose Level 1: Venetoclax 200 mg/day days 4-10 cycle 1, days 1-10 cycle 2 and 3, + R-GDP
~Dose Level 2: Venetoclax 400 mg/day days 4-10 cycle 1, days 1-10 cycle 2 and 3, + R-GDP
~Dose Level 3: Venetoclax 800 mg/day days 4-10 cycle 1, days 1-10 cycle 2 and 3, + R-GDP"
15835446|NCT04161248|Drug|RiTUXimab Injection|375 mg/m2 - Day 1, cycle 1.
15835447|NCT04161248|Drug|Rituximab SC|1400 mg fixed dose - Day 1, cycle 2 and 3
15835448|NCT04161248|Drug|Gemcitabine|1000 mg/m2 - Day 1 to day 8
15835449|NCT04161248|Drug|Dexamethasone|40 mg daily - Day 1 to day 4
15835450|NCT04161248|Drug|Cisplatin|75mg/m2 - Day 1
15835451|NCT04161235|Device|The Pulmonx Zephyr Endobronchial Valve (EBV) 5.5- LP|The Zephyr Valves are implantable bronchial valves intended to control airflow in order to improve lung function in patients with hyperinflation associated with severe emphysema and/or to reduce air leaks.
15835452|NCT04161222|Other|Experimental group|Experimental group will perform a typical warm-up of competitive football, added to a specific activation of gluteus medius and core.
15835453|NCT04161222|Other|Control group|Control group will perform a typical warm-up of competitive football
15835454|NCT04161209|Drug|Citalopram|Single dose administration of citalopram (20mg)
15835455|NCT04161209|Other|Placebo|Lactose placebo tablet
15835456|NCT04161196|Procedure|tonsil pillars suturing|The technique of suturing the faucial pillars is used routinely as part of uvulopalatopharyngoplasty, after performing the tonsillectomy, with postsurgical haemorrhage occurring rarely.
15835457|NCT04161196|Procedure|tonsillectomy without tonsil pillars suturing|tonsillectomy without The technique of suturing the faucial pillars is used routinely as part of uvulopalatopharyngoplasty, after performing the tonsillectomy, with postsurgical haemorrhage occurring rarely.
15835458|NCT04161183|Device|Extracoporeal shock wave therapy|Probe be transcutaneous applied to the region of bladder dome, right upper lateral wall, right lower lateral wall, left upper lateral wall, and left lower lateral wall with 2500 shocks, frequency of 4 pulses per second and maximum total energy flow density 0.25 millijoule/mm2 once a week for 6 weeks
15835459|NCT04161183|Device|Placebo|Probe be transcutaneous applied to the region of bladder dome, right upper lateral wall, right lower lateral wall, left upper lateral wall, and left lower lateral wall with 2500 shocks, frequency of 4 pulses per second but no energy once a week for 6 weeks
15835460|NCT04161170|Device|Digital integrated healthcare platform|Digital Integrated Healthcare Platform Utilizing AI-based Dietary Management Solution and Real-time Continuous Glucose Monitoring system
15835461|NCT04161157|Behavioral|Pathways|Goal-setting intervention to help patients identify personal values, value-consistent goals, and ways to pursue goals and address goal obstacles. Although potential refinements may occur based on aim 1 (refining procedures and content with 6 patients), Pathways is designed to consist primarily of 2 in-person sessions (~30-60 minutes) delivered when patients are in clinic for cancer treatment, with supporting phone calls and contact in between sessions.
15835462|NCT04161144|Drug|sirolimus|Rapamycin (sirolimus) is administered in three 5mg oral capsules. This administration happens once during the first visit.
15835463|NCT04161144|Drug|Placebo|Placebo is administered in three 5mg oral capsules. This administration happens once during the first visit.
15835464|NCT04161131|Behavioral|ONBOARD|Session 1: Overview; Overcoming Physical Barriers (experiential wear) Session 2: Managing CGM data (cognitive restructuring) Session 3: Social barriers (problem solving) Session 4: Trust in CGM (motivational interviewing, review of prior sessions)
15835465|NCT04161118|Drug|CTL019|IV Infusion
15835466|NCT04161105|Procedure|Dry needling|Dry needling is an invasive procedure involving inserting acupuncture needles directly into trigger points within muscles. The needle is partially withdrawn and re-inserted repeatedly to maximally stimulate the muscle and it's fibers.
15835467|NCT04161092|Procedure|Liver transplantation Ltx|Patients will be treated with Ltx at Sahlgrenska University Hospital, Göteborg, or Karolinska University Hospital, Huddinge.
15835468|NCT04161092|Other|Best alternative care|All available treatments as well as other experimental treatments are tolerated, however no cross-over to other arm will be allowed.
15835469|NCT04161079|Device|Medtentia Annuloplasty Ring (MAR)|Mitral valve repair using the MAR performed in clinical investigation 2010-040
15835470|NCT04161066|Drug|Psilocybin with guided counseling|open-label pilot study
15835471|NCT04161053|Drug|Rifaximin|Rifaximin 550 mg twice daily for 6 months
15835472|NCT04161053|Drug|Nitazoxanide|Nitazoxanide 500 mg twice daily for 6 months
15835473|NCT04161040|Behavioral|Performance-based incentives|Participants will earn $1 per minute of engagement in physical activity.
15835474|NCT04161027|Drug|Pregabalin 75mg|Pregabalin 75 mg capsule
15835475|NCT04161027|Drug|Placebos|Placebo capsule
15835476|NCT04161014|Drug|Nintedanib 150 MG [Ofev]|Nintedanib 150mg twice daily for 3 years
15835477|NCT04161001|Drug|Amlodipine/Olmesartan 10/40mg (Combination drug), Ezetimibe/Rosuvastatin 10/20mg(Combination drug)|co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg), Rosuzet Tab. 10/20mg(Ezetimibe/Rosuvastatin 10/20mg) and placebo of Olmetec Tab. 40mg(Olmesartan 40mg)
15835478|NCT04161001|Drug|Olmesartan 40mg, Ezetimibe/Rosuvastatin 10/20mg(Combination drug)|co-administration of Olmetec tab. 40mg(Olmesartan 40mg), Rosuzet Tab. 10/20mg(Ezetimibe/Rosuvastatin 10/20mg) and placebo of Sevikar tab. 10/40mg (Amlodipine/Olmesartan 10/40mg)
15835479|NCT04161001|Drug|Amlodipine/Olmesartan 10/40mg (Combination drug)|co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg, and placebo of Rosuzet Tab. 10/20mg(Ezetimibe/Rosuvastatin 10/20mg), Olmetec Tab. 40mg(Olmesartan 40mg)
15835480|NCT04160975|Behavioral|Video about safety and effectiveness of adult seasonal flu vaccination|The investigators will show subjects videos of either Black or white male actors providing scripted information on the flu vaccination. The content of the video will be the safety and effectiveness of adult seasonal flu vaccination. The videos contain one of Black or white actors playing the role of either a doctor or a layperson as well as different scripts.
15835481|NCT04160962|Procedure|lappg|Laparoscopic gastrectomy for pylorus preservation
15835482|NCT04160949|Other|No Intervention|There is no intervention for this study.
15835483|NCT04160936|Drug|Naropin Injectable Product|following PCNL under general anesthesia, patients will receive Naropin local anesthetic infiltration
15835484|NCT04160910|Drug|5-Hydroxytryptophan|Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study
15835485|NCT04160910|Drug|Placebo|Double blinded placebo controlled. 28 day dosing period followed by 3 week washout period. Then crossover to other arm of study
15835486|NCT04160897|Drug|Entecavir|entecavir naive for chronic hepatitis B patients
15835487|NCT04160897|Drug|Tenofovir Disoproxil|tenofovir disopropyl naive for chronic hepatitis B patients
15835488|NCT04160884|Procedure|Indocyanine Green Injection through Peripheral Vein|After ligation of the segmental pulmonary artery supplying the targeted segment, indocyanine is injected intravenously at a specific concentration intraoperatively.
15835489|NCT04160871|Behavioral|Family Connections|Intervention includes 12 sessions that follow a group format of 2 hours with a weekly frequency. FC program (Hoffman and Fruzzetti, 2005) is divided into six modules: 1: Updated information and research on BPD; 2: Psychoeducation on the development of BPD, available treatments and comorbidity; 3: Individual skills: self-control of emotions, mindfulness, reality acceptance skills, validation skills, etc. and skills of relationship to promote emotional well-being problem management (family skills); 4: Family skills to improve the quality of relationships in family interactions; 5: Communication skills and effective self-expression; and 6: Problem management. All modules include Practice exercises and homework. In addition, throughout the program, in order to increase social support, the FC program provides a forum where participants can stay in touch, share common problems and solutions.
15835490|NCT04160871|Behavioral|Treatment As Usual|"The intervention lasts for 3 months and includes 12 sessions that follow a group format of 2 hours and with a weekly frequency. It includes the following components: Psychoeducation about personality disorders and, specifically, BPD and how these disorders evolve. Problems associated with BPD (eg, alcohol and / or drug use, eating disorders, etc.). The importance of modeling in family members: change of attitude towards difficult situations to reduce the escalation of tension and re-establish a healthy relationship between the patient and family. The handling of problems. Crisis management: Development of safe plans for when the patient is in emotional escalation."
15835491|NCT04160858|Other|Exercise|Spinal Cord Injury Exercise Guidelines: Participants will begin at the Starting Level which is 20 mins of moderate to vigorous aerobic activity 2x/week & 3 sets of 10 repeats of strength training 2x/week. They will progress to Advanced Level which is 30 mins of moderate to vigorous aerobic activity 3x/week and 3 sets of 10 repetitions of strength training 2x/week. The intervention duration is 6 months.
15835492|NCT04160858|Other|Control|Wait-list control
15835493|NCT04160845|Procedure|cardiac surgery|cardiac surgery with hypothermic cardiopulmonary bypass
15835494|NCT04160832|Genetic|Multi-Cancer Cancer Panel|Eligible patients will receive genetic testing to determine germline cancer predisposition.
15835495|NCT04160819|Other|Assigned Interventions|Participants in the NI group received an iNIP according to energy and protein intake requirements in addition to dietary advice based on face-to-face interviews with their family members during hospitalization. After discharge, phone calls are adopted for prescribing iNIPs.
15835496|NCT04160806|Device|Transcranial direct current stimulation|Participants will receive a total of 10 stimulation sessions. During each session, 2 milliAmpers of active or sham tDCS will be applied for 20 minutes over the dorsolateral prefrontal cortex (left anodal/right anodal).
15835497|NCT04160793|Device|Genital Nerve Stimulation|Implantation the vaginal way a stimulation's electrode to the dorsal nerve of the clintoris in local anesthesia
15835498|NCT04160780|Procedure|L-PRF|sinus augmentation using L-PRf as sole graft material
15835499|NCT04160780|Procedure|L-PRF mixed with xenograft|sinus augmentation using L-PRF mixed with xenograft as sole graft material
15835500|NCT04160780|Procedure|xenograft|sinus augmentation using xenograft as sole graft material
15835501|NCT04160767|Drug|Probiotic Vivomixx|VIVOMIXX once a day for 4 months. VIVOMIXX® is a probiotic containing 8 differenct strains of bacteria: Streptococcus thermophilus DSM 24731, bifidobacteria (B. breve DSM 24732, B. longum DSM 24736, B. infantis DSM 24737) lactobacilli (L. acidophilus DSM 24735, L. plantarum DSM 24730, L. paracasei DSM 24733, L. delbrueckii subsp. bulgaricus DSM 24734). Every sachet contains 450 billions of bacteria, maltose and silicon dioxide. VIVOMIXX® will be freely given by the society MENDES S.A. - Lugano Switzerland.
15835502|NCT04160767|Behavioral|Gluten free diet|Gluten free diet will be encouraged in both arms
15835503|NCT04160767|Other|Placebo|Placebo with same taste than VIVOMIXX, containing maltose and silicon dioxide once a day for 4 months.
15835504|NCT04160754|Behavioral|Mindfulness Based Relapse Prevention|"Individuals assigned to the experimental group will receive interventions normally provided at the clinic and eight 1.5-hour group sessions of MBRP. Each sessions will occur once per week and will target a specific theme such as being aware of personal triggers, maintaining present focus, allowing or letting things be, responding to emotional and physical experiences in skillful ways, and recognizing intrusive thoughts. Each session will incorporate a mindfulness meditation technique (e.g.,SOBER breathing space and urge surfing). Participants will receive materials (e.g., recordings) with which to perform practices and meditation during the intervention phase."
15835505|NCT04160754|Behavioral|Control (CTL)|Individuals assigned to the CTL group will receive interventions provided at the clinic and up to eight CTL sessions. The CTL group will receive information (reading) and videos once per week on health behaviors (e.g., exercise, eating) and the neurobiology of addiction. This approach will reduce the possibility that intervention effects are solely due to the experimental group's receiving extra attention. In contrast to the active intervention, sessions will be educational in nature, with no motivational, cognitive, or behavioral components
15835506|NCT04160741|Other|Radiation and warm environment|"Exposure to hot environment (30°C WBGT) with radiation (800 W/m2)
~Exposure for 03:20:00:
~rest (two hours)
~work (cycling) at 100 W (one hour)
~recovery (twenty minutes)"
15835507|NCT04160741|Other|Warm environment|"Exposure to hot environment (30°C WBGT) with radiation (0 W/m2)
~Exposure for 03:20:00:
~rest (two hours)
~work (cycling) at 100 W (one hour)
~recovery (twenty minutes)"
15835508|NCT04160741|Radiation|Neutral environment with radiation|"Exposure to neutral environment (20°C WBGT) with radiation (800 W/m2)
~Exposure for 03:20:00:
~rest (two hours)
~work (cycling) at 100 W (one hour)
~recovery (twenty minutes)"
15835509|NCT04160741|Other|Neutral environment without radiation|"Exposure to neutral environment (20°C WBGT) with radiation (0 W/m2)
~Exposure for 03:20:00:
~rest (two hours)
~work (cycling) at 100 W (one hour)
~recovery (twenty minutes)"
15835510|NCT04160728|Other|Work/ rest scenario|For every hour of work, the participants were asked to take 3-10 minutes break in the shade.
15835511|NCT04160728|Other|Hydration scenario|Participants were asked to consume at least 750ml of water or ice-slushies for every hour of work
15835512|NCT04160728|Other|Clothing scenario|Participants were asked to wear different types of clothing during the work shift i.e. ventilated garments, white breathable coveralls, clothing with water submerged parts
15835513|NCT04160728|Other|"E-carts scenario"|"Participants that were involved in manual labor by carrying heavy weights were provided with e-carts (automated carrying vehicles)"
15835514|NCT04160728|Other|Business as usual scenario|No interference with the usual work day of the participants
15835515|NCT04160728|Other|Sham evaluation|Participants were monitored during a usual day of work shift while sham measurements were recorded in order for them to get familiarized with the study environment
15835516|NCT04160702|Behavioral|Motivate-The-Bystander (MTB)|MTB is a motivational interviewing intervention designed to increase bystander intervention behaviors. During MTB, participants will discuss their knowledge and experiences with bystander intervention. Participants will then create a plan to increase their bystander intervention behaviors in the future. The interviewer will utilize a variety of motivational interviewing techniques to help guide the conversation towards change (e.g., asking questions in an open-ended manner, reflecting participants' personal values).
15835517|NCT04160689|Biological|implantology|placing of implant
15835518|NCT04160676|Drug|Hydrocortisone, Ascorbic acid, Thiamine|Combination of hydrocortisone, ascorbic acid, and thiamine
15835519|NCT04160676|Drug|Normal saline|Normal saline
15835520|NCT04160663|Diagnostic Test|Carotid Ultrasound|Uses sound waves to examine the blood flow through the carotid arteries and to determine the elastic properties or stiffness of the artery.
15835521|NCT04160650|Behavioral|Educational nursing intervention on nutrition intake related chemotherapy induced side-effects' self-care among the patients with colorectal cancer|"This is an educational intervention which aims to answer the questions:
~In patients with CRC what is the effect of empowering education versus standard education on knowledge level in 4 months follow-up?
~In patients with CRC what is the effect of empowering education versus standard education on activation level related to nutrition impact side effects' self-care in 4 months follow-up?
~In patients with CRC what is the effect of empowering education versus standard education on malnutrition risk in 4 months follow-up?
~In patients with CRC what is the effect of empowering education versus standard education on QoL in 4 months follow-up?"
15835522|NCT04160637|Diagnostic Test|Immediate postoperative PTH serum sampling and cut-off value identification|The patients will undergo immediate post-thyroidectomy PTH sampling in order to establish a cut-off value for identifying patients at risk for postoperative hypocalcemia within the first 5 postoperative days.
15835523|NCT04160624|Procedure|transcatheter aortic valve replacement|Use Venus-A valve or J-Valve to perform TAVR procedure. Use cardiopulmonary bypass or cardiopulmonary bypass to provide ECLS
15835524|NCT04160611|Drug|Midazolam 7.5mg|The patient groups differ only in that respect that the intervention group will receive oral midazolam 7.5 g before oocyte aspiration.
15835525|NCT04160598|Drug|IV infusion|Control group (Placebo Group): bolus 50 ml Nacl 0.9% at the end of surgery over 20 minutes 5ml/minute infusion rate.
15835526|NCT04160598|Drug|intrathecal fentanyl|10-15mg hyperbaric bupivacaine and 30µg fentanyl intrathecally injected
15835527|NCT04160585|Other|There is no intervention.|There is no intervention.
15835528|NCT04160572|Behavioral|Morning sleep schedule|sleep right after night shifts
15835529|NCT04160572|Behavioral|Evening sleep schedule|sleep before night shifts
15835530|NCT04160559|Other|green tea|The investigators require patients to regularly drink green tea during the trial period.
15835531|NCT04160546|Drug|Ponatinib 15 MG|"Patients will receive ponatinib 15 mg/day for 104 weeks orally. Ponatinib will be self-administered by the patient on a daily schedule.
~Acetyl salicylic acid (ASA) (100 mg) will be used such auxiliary medicinal product in order to prevent vascular occlusive events related with ponatinib."
15835532|NCT04160546|Drug|Acetylsalicylic acid 100 MG|Patients will receive acetylsalicylic acid 100 mg/day for 104 weeks orally.
15835533|NCT04160520|Drug|Pramipexole|Establish proof of concept that low dose morphine in combination with pramipexole is non-inferior to standard dose morphine with respect to providing analgesia in patients presenting to the ED with pain associated with renal colic.
15835534|NCT04160520|Drug|Morphine|Establish proof of concept that low dose morphine in combination with pramipexole is non-inferior to standard dose morphine with respect to providing analgesia in patients presenting to the ED with pain associated with renal colic.
15835535|NCT04160520|Drug|Placebo oral tablet|Establish proof of concept that low dose morphine in combination with pramipexole is non-inferior to standard dose morphine with respect to providing analgesia in patients presenting to the ED with pain associated with renal colic.
15835536|NCT04160507|Other|Biorepository|To collect and store biological samples (whole blood and urine), along with relevant medical information, from adult inpatients and outpatients. Buffy coats will also be received from H3Africa Kidney Disease Research Network.
15835537|NCT04160494|Drug|D2C7-IT (6920 ng/mL via convection-enhanced delivery)|dual-specific mAB
15835538|NCT04160494|Drug|Atezolizumab (1200 mg every three weeks)|programmed cell death ligand 1 (PD-L1) blocking antibody
15835539|NCT04160494|Drug|D2C7-IT (4613.2 ng/mL via convection-enhanced delivery)|dual-specific mAB
15835540|NCT04160481|Dietary Supplement|FruitFlow|300mg tomato extract
15835541|NCT04160481|Dietary Supplement|Placebo|Maltodextrin
15835544|NCT04160455|Biological|expression of a panel|Quantify, by droplet digital PCR, the expression of a panel of 7 genes (+ GALIG) involved in autophagy2 on sub-populations (CD4+ and CD8+ lymphocytes and monocytes) after their sorting using magnetic bead cell then RNA extraction Evaluate, on a functional test (as previously described1), whether the observed expression dysregulation is associated with a deregulation of the autophagic function, whether constitutive or induced.
15835545|NCT04160442|Behavioral|Carevive CarePlanning System|Subject will complete brief survey prior to seeing provider in clinic. Utilizing the CarePlanning System, the provider will review the subject's responses directing the conversation and treatment decision will be made. A treatment careplan will be developed and given to the subject.
15835546|NCT04160429|Procedure|Biospecimen Collection|Undergo collection of sweat, saliva, and blood samples
15835547|NCT04160429|Other|Medical Chart Review|Review of medical chart
15835548|NCT04160429|Other|Questionnaire Administration|Complete questionnaire
15835549|NCT04160416|Drug|Capecitabine-Oxaliplatin-Irinotecan Combination|CAP 1,600 mg/sq.m /day (p.o. day1-10) D1-10; Oxaliplatin (OX): 68 mg/sq.m (d.i.v.) D1; Irinotecan (IRI):135 mg/sq.m (d.i.v.) D1; BEV: 5mg/kg (d.i.v.) D1; CET: 500 mg/sq.m (d.i.v.) D1; Administered every 2 weeks.
15835550|NCT04160403|Other|physical therapy intervention|NDT bases on neuroplasticity by which the brain change and reorganize itself and its processes according to practice and experience by a) facilitation of normal postural alignment and movement patterns; b) inhibition of the involvement during developmental and functional activities; and c) using sensory feedback (manual contact, visual integration, somatosensory reinforcement) for recovering function
15835551|NCT04160390|Other|Biospecimen Collection-Blood|Undergo collection of blood
15835552|NCT04160390|Other|Biospecimen Collection-Stool|Undergo collection of stool
15835553|NCT04160377|Drug|Fluvoxamine|Fluvoxamine was assigned to be the treatment for the depression patients with melancholic features or not .
15835554|NCT04160364|Other|qualitative study|qualitative research via guided interview
15835555|NCT04160351|Device|Theranova 400|medium cut-off dialyser
15835556|NCT04160351|Device|Elisio-19H|high flux dialyser
15835557|NCT04160338|Device|specular microscopy|"An informed written consent will be obtained from all patients that will be included in this study. Patients in this study will undergo specular microscopic examination of corneal endothelium before CXL procedure.
~Patients will be assigned to undergo accelerated (epithelium-off ,transepithelial ) CXL .
~Follow up specular microscopy will be done 3 months and 6 months after corneal collagen cross linking procedure ."
15835558|NCT04160325|Dietary Supplement|postoperative 3-month exclusive enteral nutrition|postoperative 3-month exclusive enteral nutrition after surgery and alter to normal food after 3 months
15835559|NCT04160325|Drug|azathioprine|azathioprine
15835560|NCT04160325|Other|normal diet|normal diet
15835561|NCT04160312|Dietary Supplement|Mitopure™ (Proprietary Urolithin A)|Fruit flavored sachet containing fixed dose of Mitopure™ (Proprietary Urolithin A)
15835562|NCT04160312|Dietary Supplement|Pomegranate Juice|100% Pomegranate juice (approximately 1 glass equivalent)
15835563|NCT04160299|Behavioral|Dance-based exergaming|Dance sessions
15835564|NCT04160286|Other|Electroconvulsive therapy|"Electroconvulsive therapy is a procedure, done under general anesthesia, in which small electric currents are passed through the brain, intentionally triggering a brief seizure.
~Repeated as deemed needed by the patients' doctor. Typically prescribed 10 times (3 times pr week)"
15835565|NCT04160273|Diagnostic Test|patient questionnaire and telephone follow-up|PDI scale is filled in before returning home and follow-up at one month and one year thanks to a telephone call during which the patient answers the PCL-S questionnaire
15835566|NCT04160260|Drug|Omadacycline|Omadacycline: PO Tablets
15835567|NCT04160247|Procedure|Immediate implant placement|Implants are placed in fresh socket
15835568|NCT04160247|Procedure|Angulated screw-retained crowns placement|To insert the restorations by angulated screw systems
15835569|NCT04160247|Procedure|Cemented crowns placement|To cement the restorations onto the implant abutment
15835570|NCT04160234|Other|web-based questionnaires|Patients will be asked to complete web-based questionnaires on a tablet computer
15835571|NCT04160221|Other|12 hours interval|Time interval between treatments
15835572|NCT04160221|Other|24 hours interval|Time interval between treatments
15835765|NCT04158622|Procedure|PnR + laser/cryotherapy|Pneumatic retinopexy plus laser/cryotherapy
15835573|NCT04160195|Biological|Anti-CD19-CAR and Anti-CD20-CAR T cells|Dose-escalation trial starting dose: 0.66 x106 CAR+ T cells/kg (weight based dosing one time)(up to a maximum dose of 10x106 CAR+ T cells/kg based on cohort) infuse on day 0
15835574|NCT04160195|Drug|Cyclophosphamide|500 mg/m2 IV infusion over 30 minutes on days -5, -4 and -3
15835575|NCT04160195|Drug|Fludarabine|30 mg/m2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4,and -3
15835576|NCT04160182|Behavioral|Energy Conservation Work Simplification Education|"The intervention will last approximately 45 minutes, and will be provided once/week for 6 weeks. The intervention is delivered live using web-cameras (e.g., Microsoft Zoom).
~Registered and licensed occupational therapists will deliver the intervention. At beginning of the intervention, the participant and interventionist prioritize the 5 most critical fatigue-related problems that they would like to solve during the intervention. Each week, the interventionist will guide the participant through a workbook to provide knowledge and examples on how to apply the knowledge to everyday fatigue-related problems. The workbook contains: (a) information regarding fatigue in breast cancer survivors, (b) knowledge regarding fatigue management strategies, and (c) worksheets to develop skills to recognize and solve fatigue-related problems. Participants will retain the workbook after study completion."
15835577|NCT04160169|Other|Counseling messages on injectable use and HIV acquisition risk|Counseling messages based on 2017 World Health Organization guidance, a review of the Strategic Communication Framework for Hormonal Contraceptive Methods and Potential HIV-related Risks, and the Family Planning Global Handbook were provided to clients expressing interest in injectables during regular family planning appointments.
15835578|NCT04160156|Device|Long term sensor|Observational study including subjects using long term sensor according to local guidelines and patients preferences
15835579|NCT04160143|Procedure|Surgical resection and stereotactic body radiation therapy (SBRT)|Surgical resection and stereotactic body radiation therapy (SBRT) are generally regarded as mutually exclusive treatment options for the local management of pulmonary malignancies. This Phase 2 prospective trial is a collaborative effort between the divisions of Thoracic Surgery and Radiation Oncology to evaluate the effects of dual treatment of pulmonary metastasis amenable to curative resection with neoadjuvant SBRT followed by surgical resection.
15835580|NCT04160130|Procedure|Transcatheter aortic valve replacement|Patients will be randomized 1:1 to receive either transcatheter aortic valve replacement (TAVI) or aortic valve replacement with a commercially available surgical bioprosthetic valve.
15835581|NCT04160117|Drug|Colchicine 0.6 mg|p.o. twice daily for 10 days after catheter ablation for atrial fibrillation
15835582|NCT04160117|Drug|Matching placebo|p.o. twice daily for 10 days after catheter ablation for atrial fibrillation
15835583|NCT04160104|Other|Questionnaire|Patients were asked to complete a questionnaire before colonoscopy. Bowel preparation was subsequently assessed by single endoscopist in each center using Boston bowel preparation quality score (BBPS). Both univariate and multivariate logistic regression models were used to identify high-risk factors associated with IBP and a predicting model with the bowel preparation score (BPS) was developed in the training cohort.
15835584|NCT04160104|Other|Questionnair|Patients were asked to complete a questionnaire before colonoscopy. The predicting modle established by the training cohort will be used to assessing the preparation of validation cohort. The result will compared with endoscopists assessment of preparation.
15835585|NCT04160091|Drug|FX006|Single intra-articular injection
15835586|NCT04160091|Drug|Normal Saline|Single intra-articular injection
15835587|NCT04160078|Behavioral|Mindfulness-based stress reduction (MBSR) Intervention|"1-hour session on sleep hygiene and 7-week follow up using a mindfulness app, an app that features guided meditation and can be used to assess adherence.
~Sleep log diary: self report of sleep records
~Wrist Actigraphy, to monitor sleep patterns. Participants will be instructed on wearing the sleep monitor (Spectrum, Philips Respironics, Murrysville, PA) on their non-dominant wrist for the next 7-weeks"
15835589|NCT04160052|Drug|Azacitidine|Given SC or IV
15835590|NCT04160052|Drug|Venetoclax|Given PO
15835591|NCT04160039|Device|Cycle ergometry|Lower extremity cycle ergometry, passive and/or active, up to 20 minutes per session, up to 5 sessions per week
15835592|NCT04160026|Drug|Monthly intermittent preventive treatment with dihydroartemisnin-piperaquine|Feasibility study to assess adherence among health providers in antenatal clinics delivering the study interventions in a routine setting and uptake and adherence among pregnant women.
15835593|NCT04160026|Drug|Monthly intermittent preventive treatment with sulfadoxine-pyrimethamine|Feasibility study to assess adherence among health providers in antenatal clinics delivering the study interventions in a routine setting and uptake and adherence among pregnant women.
15835594|NCT04160026|Drug|Monthly intermittent preventive treatment with dihydroartemisnin-piperaquine with targeted information transfer|Feasibility study to assess adherence to guidelines among health providers in antenatal clinics delivering the study interventions in a routine setting and uptake and adherence among pregnant women.
15835595|NCT04160013|Behavioral|Discipline education|Discipline education using the Play Nicely program.
15835596|NCT04160013|Behavioral|Cavity Prevention|Cavity prevention using a 2 page handout.
15835597|NCT04160000|Device|Catheter ablation|Delivery of physical energy from external energy source via percutaneously inserted electrophysiologic catheter to destroy heart tissue in the human atrium and adjoining vasculature
15835598|NCT04160000|Drug|Rate or Rhythm control antiarrhythmic drugs for atrial fibrillation|Administration of antiarrhythmic drug to achieve either rate control or restoration of sinus rhythm for management of atrial fibrillation
15835599|NCT04160000|Device|Insertion of CardioMems Hemodynamic monitor|Insertion of wireless hemodynamic monitor to provide hemodynamic data to guide heart failure therapy to achieve heart failure improvement.
15835600|NCT04160000|Drug|Empiric heart failure drug therapy|Administration of heart failure drug therapy based on clinical evaluation to achieve heart failure improvement.
15835601|NCT04159987|Other|Spinraza intrathecal injection|The aim is to monitor the evolution of the Motor Function Measure-32 for SMA type II adult patients treated with SPINRAZA® (Nusinersen).
15835602|NCT04159974|Drug|Durvalumab 50 MG/ML|IV Infusion
15835603|NCT04159974|Drug|Tremelimumab|IV Infusion, Combination with Durvalumab
15835604|NCT04159961|Drug|DWJ211|Inject the Drug into submental fat and abdominal fat via subcutaneous
15835605|NCT04159948|Dietary Supplement|Carbohydrate drink|"This is a commercially available pre-op carbohydrate drink used in enhanced recovery programmes."
15835606|NCT04159935|Device|iLux® system|Commercially available medical device intended for use by qualified eye care professionals to apply localized heat and pressure therapy to a patient's eyelids.
15835607|NCT04159922|Other|questionnaire|Bortner self questionnaire: 14 items Cohen PSS Perceived Stress scale: 10 items quality of life scale: 32 items depression scale: 14 items
15835608|NCT04159909|Device|Transcutaneous Nerve Stimulation|510(K) number: K110390 vagus nerve for 5 minutes twice a day for 4 consecutive days
15835609|NCT04159909|Device|Sham Stimulation|sham stimulation (no electrical current) for 5 minutes twice a day for 4 consecutive days
15835610|NCT04159896|Drug|Pan-VEGFR/TIE2 Tyrosine Kinase Inhibitor CEP-11981|Given PO
15835611|NCT04159896|Biological|Nivolumab|Given IV
15835612|NCT04159883|Other|strengthening exercise program for lower-extremity muscles (knee extensor and hip abductor muscles)|Simple progressive strengthening exercise program for lower-extremity muscles (knee extensor and hip abductor muscles), the program has been evident to be significantly effective in improving self-reported knee pain and function. This program included: 1) Isometric quadriceps contraction, 2) Isotonic quadriceps contraction, 3) Isotonic hamstring contraction, 4) Isotonic quadriceps contraction with resistance band, 5), straight leg raising, 6) Side-lying hip abduction, 7) Partial Squats,
15835613|NCT04159883|Other|"My Dear Knee smart phone application"|"The innovative app has been designed for Android and iPhone Operating System (iOS). The app provides guides with the Arabic language. It designed to be attractive for the older adult and easy to use. the exercises are demonstrated with colorful animated images to make easy to follow by the patients.
~The app supports features such as alerts, monitoring system by the physical therapist and remote follow-up. The app provides automatic recording of exercise adherence, including the time and the number of sessions completed for the week in the physical therapist's account."
15835614|NCT04159870|Drug|Rifaximin|Rifaximin pills 400 mg x 3/day
15835615|NCT04159870|Drug|Norfloxacin|Norlfloxacin 400 mg 1 pill/day
15835616|NCT04159857|Procedure|Fetal head extraction technique during the cesarean section|see above for the description about one-hand and two-hand fetal head extraction technique
15835617|NCT04159844|Device|URGOBD001|Application with 50% overlapping
15835618|NCT04159844|Device|URGOBD001 associated with wading|Application with 50% overlapping in association with wading
15835619|NCT04159831|Drug|LTI-01|single-chain urokinase plasminogen activator, scuPA
15835620|NCT04159831|Drug|Placebo|normal saline
15835621|NCT04159818|Drug|Nivolumab|240 mg flat-dose, every 2 weeks. From 20 weeks onwards, nivolumab will be administered every 4 weeks with a flat-dose of 480 mg starting from week 20 onwards
15835622|NCT04159818|Drug|Cisplatin|40mg/m2, weekly for two weeks
15835623|NCT04159818|Drug|Low dose doxorubicin|15mg flat dose, weekly for 8 weeks
15835624|NCT04159805|Drug|TAK-079|TAK-079 subcutaneous injection
15835625|NCT04159805|Drug|TAK-079 Placebo|TAK-079 placebo-matching subcutaneous injection
15835626|NCT04159792|Other|no intervention|No intervention
15835627|NCT04159766|Drug|NLY01|NLY01, a PEGylated form of the anti-diabetic peptide exenatide
15835628|NCT04159766|Drug|Placebo|normal saline
15835629|NCT04159753|Device|Spinal Cord Stimulator|We will record patient's experience on the 30-Day FDA approved Burst Spinal Cord Stimulator Trial (BurstDR™, Abbott Saint Jude Medical).
15835630|NCT04159740|Other|Tissue and blood collection|Tissue and swab (cells) collection for microbiome analysis. Blood collection for immune markers.
15835631|NCT04159727|Other|stool and blood analysis|High throughput sequencing and quantitative PCR
15835632|NCT04159714|Device|Air Optix contact lens|Contact lens will be placed on the surface of the patient's eye and is to be used as a bandage
15835633|NCT04159701|Drug|LY3454738|Administered IV
15835634|NCT04159701|Drug|Placebo|Administered IV
15835635|NCT04159688|Drug|Alcohol|Alcohol Challenge
15835636|NCT04159675|Biological|osteoblast biology study|Describe the in-vitro action of burosumab and vitamin D on human osteoblastogenesis from osteoblasts from patients with craniosynostosis due to HR
15835637|NCT04159662|Behavioral|Cognitive Intervention|In each of the 6 visits, participants will be completing some computerized tasks for a period of about 40 minutes. At the end of each session, there will be 10-15 minutes of bridging discussion between the research therapist and the participants. (More details about each condition will be added after study completion to protect the blinding of our participants) .
15835638|NCT04159662|Behavioral|Active Control Intervention|In each of the 6 visits, participants will be completing some computerized tasks for a period of about 40 minutes. At the end of each session, there will be 10-15 minutes of bridging discussion between the research therapist and the participants. (More details about each condition will be added after study completion to protect the blinding of our participants) .
15835639|NCT04159649|Drug|Letrozole 2.5Mg Tablet|Gonadotropins with or letrozol in fixed Gn RH antagonist IVF protocol
15835640|NCT04159649|Drug|Gonadotropins|Gonadotropins without letrozol in fixed Gn RH antagonist IVF protocol
15835641|NCT04159649|Procedure|endometrial sample in the pretreatment cycle|All participant will be exposed to mid luteal endometrial sample in the pretreatment cycle. couples will be asked to use condom in the pretreatment cycle.
15835642|NCT04159636|Other|Carbohydrate beverage|The participants in this group are allowed to drink carbohydrate until 2 hours before surgery
15835643|NCT04159623|Device|Belk Device|Knee exoskeleton with electrostimulation
15835644|NCT04159623|Other|Standard Rehabilitative treatment|Use the standard rehabilitative treatment
15835645|NCT04159610|Drug|WO3970|Application of cream to each axilla
15835646|NCT04159610|Drug|Qbrexza® (glycopyrronium) cloth, 2.4%, for topical use|Qbrexza should be applied to the clean, dry, intact skin, of your underarm areas only
15835647|NCT04159597|Drug|Upadacitinib|Upadacitinib will be administered as oral tablet.
15835648|NCT04159584|Other|Medical Music|Enrolled subjects will undergo 30 minutes of medical music listening
15835649|NCT04159571|Device|Real cTBS to the vmPFC|This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key)
15835650|NCT04159571|Device|Sham cTBS to the vmPFC|This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.
15835651|NCT04159571|Device|Real iTBS to the dlPFC|This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key).
15835652|NCT04159571|Device|Sham iTBS to the dlPFC|This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.
15835653|NCT04159558|Device|Mobile application|Experimental group will use a mobile application to help them in their self-care
15835654|NCT04159545|Other|Qualitative and quantitative interviews|Qualitative semi-structured interviews and quantitative questionnaires
15835655|NCT04159532|Dietary Supplement|MAG-EPA/MAG-DHA|monoglyceride of eicosapentaenoic acid and docosahexaenoic acid in proportion of 460:200
15835656|NCT04159532|Dietary Supplement|TG-EPA/TG-DHA|Triglyceride of eicosapentaenoic acid and docosahexaenoic acid in proportion of 460:200
15835657|NCT04159532|Dietary Supplement|EE-EPA/EE-DHA|Ethyl ester of eicosapentaenoic acid and docosahexaenoic acid in proportion of 460:200
15835658|NCT04159519|Drug|Symbicort®|Participants will receive Budesonide 400 μg/formoterol fumarate 12 μg per inhalation and Budesonide 200 μg/formoterol fumarate 6 μg per inhalation.
15835659|NCT04159519|Drug|Fasenra®|Participants received Benralizumab 30 mg/mL, 1 mL fill volume via Subcutaneous every 4 weeks for first 3 doses.
15835660|NCT04159519|Drug|Ventolin®|Participants received Salbutamol sulfate 100 μg per inhalation as needed.
15835661|NCT04159506|Behavioral|mindfulness, emotion didactics, interpersonal skills, experiential learning|mindfulness interventions involve body scanning, deep breathing, and muscle relaxation. Emotion didactics focus on emotion recognition and regulation. Interpersonal skill development looks at how to use emotion regulation to improve social functioning. Experiential learning means learning either through interactions with horses or via team-building activities.
15835662|NCT04159493|Drug|Estriol|Vaginal Application
15835663|NCT04159493|Drug|Placebo|Vaginal Application
15835664|NCT04159480|Device|Experimental - Cogito Companion|Cogito Companion
15835665|NCT04159480|Behavioral|Active Control|Use of MyCAP
15835666|NCT04159467|Other|Pelvic Floor Muscle Training|4 sets of 10 maximal perceived voluntary pelvic floor contractions sustained for 6 seconds, followed by 5 voluntary pelvic floor muscle contractions. The supervised 4 sets will be performed in 2 different positions (sitting and standing).
15835667|NCT04159454|Device|PITA|Patients will have PITA turned on to patients' existing Medtronic devices, such that patients will be RV-paced from midnight to 6 AM each night at a rate ~10 beats per minute (BPM) above patients' baseline heart rates during this time period as determined by Holter monitors.
15835668|NCT04159441|Other|None intervetion|None intervetion
15835669|NCT04159428|Diagnostic Test|HHIE-S survey score|"First, the patient will fill in the French translation of the HHIE-S questionnaire in the observation book.
~Secondly, he will perform the audiometry in silence test: for the tonal test in silence, we will test the frequencies 500, 1000, 2000 and 4000 hertz in each ear with pure tone sound. For the vocal in silence test, we will use the dissyllabic lists of words (Fournier's lists) at the intensities of 20, 30, 40, 50 and 60 decibels. This test will be in free-field conditions testing both ears.
~Thirdly, he will perform the speech in noise audiometry test that consists in repeating sentences pronounced at an equal intensity (60 decibels) while the intensity of the noise is increasing. This test will be in free-field conditions testing both ears."
15835670|NCT04159415|Drug|Placebo|Intravenous (IV) infusion loading dose or subcutaneous (SC) injection weekly (QW).
15835671|NCT04159415|Drug|Low-Dose REGN4461|IV infusion loading dose or SC injection QW.
15835672|NCT04159415|Drug|High-dose REGN4461|IV infusion loading dose or SC injection QW.
15835673|NCT04159389|Other|Mental visualization|Instruction in mental visualization by theoretical lessons and support of practice by audio guide and session of experience sharing.
15835674|NCT04159376|Diagnostic Test|PET/MR|"All patients will have a PET/CT and PET/MR study performed at the same clinical setting using a single dose of tracer administration.
~The study cohort includes 150 patients 18 years or older, having metastatic skeletal involvement on baseline PET/CT prior to treatment. Baseline studies and follow up studies of the patients referred post treatment, will be reviewed.
~The tracers will be FDG, labelled PSMA labelled Somatostatin and F-DOPA in order to assess skeletal lesions detection of all tumor types.
~Skeletal lesions will be divided into marrow-based lesions, lytic, blastic and scleroric lesions. Tracer uptake will be measured at baseline and after treatment. Metabolic PET parameters, CT appearance and MR parameters will be assessed.
~The best MR-based attenuation algorithm for detection of lesions and monitoring response will be derived."
15835675|NCT04159363|Other|An interactive Colorectal Cancer self-Management enhancement smartphone-based psychosocial intervention programme (iCanManage)|The iCanManage consists of two components: (1a) Existing functions from the BuddyCare mobile application that provide a comprehensive 29 day-by-day perioperative guide for patients who will be undergoing colorectal elective surgery; (1b) a dashboard for healthcare professionals to monitor patients and their caregivers' well-being as well as allow mutual communication; and (2) Newly developed digitalised psychosocial content (e.g., mindfulness-based activities with audio cover, video materials related to positive psychology, patient ambassadors' success stories and relevant psychoeducation) tailored for colorectal cancer patients and caregivers, with the aim of providing them emotional and psychosocial support.
15835766|NCT04158622|Procedure|PPV + laser/cryotherapy|Pars plana vitrectomy plus laser/cryotherapy
15835767|NCT04158609|Diagnostic Test|Doppler flow indices assessment|Doppler flow indices, UA-PI, MCA-PI and CPR values, assessment performed prior to induction of labor
15835676|NCT04159350|Device|Rectal Expulsion Device (RED) - Feasibility|"After a complete physical exam at bedside including a digital rectal exam, the patient is turned on their side and RED is gently inserted into the rectum. The patient is then given one minute to expel RED while remaining on their side. If the patient is unable to pass RED, the patient transfers to a commode and attempts to expel the device. If the device is not expelled, the device can be safely removed at bedside and the patient diagnosed with a biofeedback-responsive evacuation disorder.
~The RED device is manufactured by Rose Medical (Grand Rapids, MI) under GMP conditions and final assembly is performed by In2Being (Saline, MI). The device contains accepted technologies that are already in use of humans, namely biomedical grade materials."
15835677|NCT04159350|Device|Rectal Expulsion Device (RED) - Validation|"After a complete physical exam at bedside including a digital rectal exam, the patient is turned on their LEFT side and RED is gently inserted into the rectum. The patient then attempts to expel RED while remaining on their side. If the patient is unable to pass RED, the patient transfers to a commode and attempts to expel the device. If the device is not expelled, the device can be safely removed at bedside and the patient diagnosed with a biofeedback-responsive evacuation disorder.
~The RED device is manufactured by Rose Medical (Grand Rapids, MI) under GMP conditions and final assembly is performed by In2Being (Saline, MI). The device contains accepted technologies that are already in use of humans, namely biomedical grade materials."
15835678|NCT04159337|Other|The method of gene mutation detection|All samples were detected by large-panel, whereas some of which were also detected by WES.
15835679|NCT04159324|Other|optimized cross-sectoral, structured and coordinated treatment pathway that integrates a patient-centred outcome evaluation|the optimized treatment pathway includes coordinated transitions between rehabilitation phases and institutes using individual case management and portal solutions
15835680|NCT04159311|Other|Osteopathy|testing osteopathy Vs Treating osteopathy
15835681|NCT04159298|Device|Top Spin 360|The TopSpin360 is a dynamic multi-planar neuromuscular training device that has been shown to improve static and dynamic multi-planar neck strength in a healthy athletic population
15835682|NCT04159285|Behavioral|EffEKTiv 2.0 group CBT as continuation treatment after ECT in depressed patients|Group CBT with a maximum number of 8 participants. Group is half-open allowing a starting date right after completion of acute ECT treatment. Patients participate for 15 sessions, which are framed by 2 individual sessions before joining the group and one individual session at treatment end.
15835683|NCT04159285|Other|Treatment as usual|Can include continuation ECT, psychopharmacological treatment, individual psychotherapy
15835684|NCT04159272|Behavioral|Mindfulness Training|"The programme consists of 8 90-min sessions held once a week for 8 consecutive weeks. Each session consists of guided experiential mindfulness exercises, sharing of experiences of these exercises, reflections in small groups, psycho-education, and review of home practices. An overview of the core elements in each session is given in Van der Gucht et al. (2017). The in-class MT programme will be supported with a mindfulness for adolescents smartphone application to support practice at home.
~The curriculum is available in an open source platform. The training is supported by the use of homework assignments and audio material. The programme has already been piloted and reviewed in an expert group of mindfulness trainers and scientists working with youth in mental health care (Van der Gucht et al., 2017) and in refugee centres (Van der Gucht et al., 2019). The MT will be delivered by certified trainers (>3 years of experience). During the trial they will receive regular supervision."
15835685|NCT04159259|Other|Low fiber diet|Participants will be provided with a low fiber diet in the form of packed out meals and snacks for 24 days in total (days 5-14 and days 36-49)
15835686|NCT04159259|Other|Pea Fiber Bar|Participants will be provided with a low fiber diet plus 1-3 daily pea fiber bars from days 15-35
15835687|NCT04159259|Other|Low fiber diet|Participants will return to the low fiber diet for days 36-49- this phase is the same as phase 1.
15835688|NCT04159246|Device|Optical coherence tomography angiography|"Recent Optical coherence tomography angiography OCT-A will be performed to all patients before Treatment Administration.
~Examination will be performed using Optovue AngioVue® Optovue, Inc., Fremont, CA, which uses split-spectrum amplitude-decorrelation angiography algorithm, which minimizes motion noise. This system also allows quantitative analysis, since it provides numerical data about flow area and flow density maps.
~The patient will be examined before and after finishing the treatment course"
15835689|NCT04159246|Drug|Sofosbuvir (Sovaldi)|Sofosbuvir (tradename Sovaldi) is a direct acting antiviral medication used as part of combination therapy to treat chronic Hepatitis C , here it's used with Daclatasvir for 3 months
15835690|NCT04159233|Behavioral|Brief Behavioral Therapy for Insomnia (BBTI)|Participants will receive evidence-based 'Brief Behavioral Therapy for Insomnia' (BBTI), tailored to meet the needs of former football players. BBTi is a brief, efficacious treatment that focuses on modifying behaviors, rather than cognitive domains. The treatment emphasizes education, motivational tools, and specific behavioral recommendations (e.g., restricting time in bed) and will be administered through weekly phone calls with a trained sleep interventionist over 4-weeks.
15835691|NCT04159220|Procedure|Clamping of the ventilator endotracheal tube|The transport will be released in accordance with SFAR SRLF guideline. Before each disconnection from ventilator endotracheal tube will be clamped.
15835692|NCT04159194|Other|Control Diet|Players during the control trial will be instructed to maintain their normal food intake (~55% CHO) and the type and amount of ingested food will be recorded.
15835693|NCT04159194|Other|Experimental Diet|The experimental diet will be administered by the investigators after M1, daily for the next 48 hours (three main meals, i.e. breakfast, lunch, and dinner, and snacks such as energy bars and raisins), and before M2 (breakfast and lunch)
15835694|NCT04159181|Other|Lactulose|Oral solution lactulose (20g lactulose/200mL water).
15835695|NCT04159181|Other|Picoprep|Cathartic to accomplish an evacuation of the colonic content.
15835696|NCT04159181|Other|Placebo (water)|oral administration of Water (200mL).
15835697|NCT04159168|Behavioral|Facial Affect Sensitivity Training (FAST)|The FAST intervention program represents a novel computerized intervention for high-risk youth that strategically targets implicated facial affect sensitivity deficits directly via a computerized real-time automated feedback and incentive system to remediate callous-unemotional tendencies associated with behavioral dysfunction.
15835768|NCT04158596|Device|Vibration Therapy|SDX-3101 is used for drug-free treatment of CRSsNP in adults.
15835769|NCT04158583|Drug|RO7296682|RO7296682 will be administered as per the schedules specified in the respective arms.
15835698|NCT04159168|Behavioral|Implicit Gaze Training task (Active control condition)|"This computerized task was developed to target implicit training of eye gaze but not facial emotion recognition per se via real-time feedback and incentives. On each trial, a fixation cross is followed by an emotional face with eyes directed either left, straight ahead, or right (balanced across expressions), followed by a response key. The child's task is to say which direction the eyes are looking (e.g., 1 or left). Stimuli are black and white standardized photographs of men and women models from the Ekman Pictures of Facial Affect each displaying the 3 gaze directions for 6 emotion expressions."
15835699|NCT04159155|Drug|Cisplatin|Chemotherapy drug given by vein.
15835700|NCT04159155|Radiation|External Beam Radiation|Radiation therapy given outside the patient to a particular part of the body.
15835701|NCT04159155|Drug|Carboplatin|Chemotherapy drug given by vein.
15835702|NCT04159155|Drug|Paclitaxel|Chemotherapy drug given by vein.
15835703|NCT04159155|Drug|Niraparib|Oral drug
15835704|NCT04159142|Drug|Nab-paclitaxel + Carboplatin|nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and carboplatin given IV at AUC 5 on days 1 every 21 days x 6 cycles；
15835705|NCT04159142|Drug|Nab-paclitaxel + Capecitabine|Nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and capecitabine given IV at 1000 mg/m^2 bid, d1-14 every 21 days x 6 cycles；
15835706|NCT04159116|Other|Prophylactic suctioning when clinically indicated|Suctioned prophylactically when clinically indicated by copious secretions, coughing, choking or desaturatation
15835708|NCT04159090|Diagnostic Test|F18-PSMA|Patients with moderate or high risk of prostate cancer
15835709|NCT04159077|Drug|Tamsulosin Hydrochloride|"Tamsulosin HCL is an alpha blocker. It relaxes the muscles in the prostate and bladder neck, making easier to urinate. The dosage used will be 0.4 mg (administered once daily)
~Other names: Flomax"
15835710|NCT04159077|Drug|Placebos|Half of the patients will be assigned to receive placebo tablets in the same manner as the active intervention. These tablets will have no effect.
15835711|NCT04159064|Diagnostic Test|Thromboelastometry, Impedance Aggregometry|Study of coagulation changes after cardiac surgery on CPB using Minimal Extracorporeal Circulation
15835712|NCT04159051|Device|Regional Hyperthermia|Regional hyperthermia 1-2×/week to a total number of 7-10 treatments combined with salvage radiotherapy to a total dose of 70 Gy over 7 weeks
15835713|NCT04159038|Other|Intervention Group|The immediate intervention group will receive training on how to identify children at risk for developmental disabilities and how to refer to Early Intervention/Early Childhood Special Education.
15835714|NCT04159038|Other|Control group|The control group will continue usual WIC care.
15835715|NCT04159025|Device|CoreDx Pulmonary Mini-Forceps|Manufactured by Boston Scientific
15835716|NCT04159012|Device|Transcranial direct current stimulation|"A Sooma transcranial direct current stimulator, using carbon electrodes, a reusable cap (to promote reproducible electrode placement), and disposable sponges that will be soaked in normal saline.
~The anode will be positioned over the left dorsolateral prefrontal cortex (position F3 on the 10-20 the International EEG system), and the cathode will be positioned over the right dorsolateral prefrontal cortex (position F4)."
15835717|NCT04158999|Device|milk analyzer|Human Milk Sample
15835718|NCT04158999|Behavioral|Mother's nutrition values|evaluation of nutritional elements of maternal onset with Bebis Program
15835719|NCT04158986|Behavioral|Nurse-driven post-discharge intervention|"Home visits based on the concepts of Family Nursing:
~The participants will receive three home visits by a nurse who is trained in the Family Nursing principles during the first 12 weeks after discharge.
~The home visits will comprise of:
~Filling in the Chronic Liver Disease Questionnaire.
~Therapeutic conversations including drawing and review of genogram and eco-map.
~Information about- and help to initiate contact to relevant municipal offers.
~Evidence-based information based on the patient's current problems or symptoms, base-line knowledge and receptiveness.
~Follow-up telephone calls:
~• After the first 12 weeks participants will be followed-up by telephone monthly during the following 12 weeks.
~Pamphlet:
~• All participants will receive a pamphlet with brief information regarding preventive measures and early signs of decompensation as well as relevant contact details. The pamphlet will be handed out before discharge"
15835720|NCT04158973|Other|Bleeding-risk based prophylaxis strategy during hospitalization and extended pharmacological treatment after discharge|At admission, patents undergo bleeding risk assessment and receive prophylaxis according to bleeding risk. After discharge, they will undergo an extended treatment of 5mg Rivaroxaban once daily for 15 consecutive days,
15835721|NCT04158973|Other|Routine VTE prophylaxis in hospital|Patients randomized to the standard treatment (Control) group will receive routine VTE prophylaxis according to current guidelines and clinical practices, VTE risk assessment and prophylaxis if indicated during hospitalization according to current policies for hospitals in China but no further treatment prophylaxis after discharge
15835722|NCT04158960|Behavioral|Equine-assisted activities|Participants performed riding-related activities on and off of a horse once per week for 8 weeks
15835723|NCT04158960|Behavioral|GaitWay program|Participants performed riding-related activities on and off of a horse, along with brain-building activities including balance tasks, swinging, spinning, music therapy, and sensory tasks, all once per week for 8 weeks
15835724|NCT04158947|Drug|Afatinib|"Dose-escalation Phase (Phase I) - Afatinib Dose-escalation will proceed on the basis of dose limiting toxicity (DLT) during Cycle 1 starting at 20 mg/day.
~Dose level 1: 20 mg/day; Dose level 2: 30 mg/day; Dose level 3: 40 mg/day; Dose level 4: 50 mg/day.
~Dose-evaluation Phase (Phase II) - Patients will receive the highest dose of Afatinib with T-DM1 found in Phase I as study therapy"
15835725|NCT04158947|Drug|T-DM1|"Dose-escalation Phase (Phase I) - Trastuzumab emtansine (T-DM1) will be given at 3.6 mg/kg IV Day 1 every 21 days.
~Dose-evaluation Phase (Phase II) - Trastuzumab emtansine (T-DM1) will be given at 3.6 mg/kg IV Day 1 every 21 days."
15835726|NCT04158934|Biological|ADYNOVI/ADYNOVATE|Participants will receive ADYNOVI/ADYNOVATE prescribed prophylactically by physicians based on their standard clinical practice and in accordance with the national SmPC.
15835759|NCT04158648|Drug|Emicizumab|Four loading doses of emicizumab 3 mg/kg will be administered subcutaneously once a week (QW) for 4 weeks followed by participant's preference of one of the following maintenance regimens: 1.5 mg/kg QW, 3 mg/kg once every 2 weeks (Q2W), or 6 mg/kg once every 4 weeks (Q4W).
15835727|NCT04158921|Other|Control:Diabetes mobile app|The Control:Diabetes app will encourage patients to: a) predict their blood glucose level at a particular time point in the future (e.g. the next morning); then b) enter their actual blood glucose levels when that time (the next morning) comes; and c) enter reasons for the discrepancy between prediction and reality, if the prediction was significantly (e.g. > 20%) different from the actual measurement. We hypothesize that by repeatedly encouraging disassembly of blood glucose changes into individual reasons (cognitive task analysis) while providing an incentive in the form of being able to more accurately predict blood glucose levels (operant conditioning), the app will prompt the patient to learn how various internal and environmental factors affect their blood glucose. They will then be able to adjust their behavior and medications to improve their blood glucose control.
15835728|NCT04158908|Behavioral|Oncolo-GIST|"Oncolo-GIST is a brief, manualized communication intervention that guides oncologists in gist communication by itemizing 4 key steps in the process of imparting prognostic information.
~Topic covered include:
~Principles of introducing prognosis in the setting of worsened scan results
~Coupling communicating realistic prognoses with psychological support (e.g., saying average life-expectancy is months… with emphasizing that the oncology team will always provide care for you)
~Addressing informational needs and psychological reactions
~Applying proven techniques for supporting patients who are reluctant to discuss prognosis.
~The 4-step guide will include brief video-clips of demonstrating each talking point with a standardized patient, including ideal scenarios, common pitfalls to avoid, and how to respond to patient reactions that are particularly challenging, such as responding to optimism, death anxiety, and reliance on faith."
15835729|NCT04158895|Other|Routine medical record data collection|The study will collect routine medical record data from the electronic medical record system, other electronic databases, and paper charts.
15835730|NCT04158882|Other|Routine medical record data collection|The study will collect routine medical record data from the electronic medical record system, other electronic databases, and paper charts.
15835731|NCT04158856|Drug|Pyrotinib|400mg po every day
15835732|NCT04158856|Drug|Trastuzumab|Trastuzumab is administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg every 21 days
15835733|NCT04158843|Procedure|Radical resection|Radical resection is performed, and the cutting edge is negative.
15835734|NCT04158843|Radiation|Radical radiotherapy|Radical local radiotherapy is feasible (cumulative radiotherapy dose is greater than or equal to 50Gy).
15835735|NCT04158843|Other|Palliative treatment|Including palliative internal fixation, radiotherapy, systemic chemotherapy, endocrine therapy or targeted therapy
15835736|NCT04158830|Drug|Aspirin 81 mg Enteric Coated Tab - 1 tablet|take one (1) 81 mg tablet each evening
15835737|NCT04158830|Drug|Aspirin 81 mg Enteric Coated Tab - 2 tablets|take two (2) 81 mg tablets each evening
15835738|NCT04158817|Drug|68Ga-Labeled PSMA|All participants in the study will be injected with 68Ga-THP-PSMA at a dose of 2.11 MBq/kg in a single dose injection.
15835739|NCT04158817|Drug|Non-labeled PSMA|Patient will be injected with microdose (<100 ug) of THP-PSMA
15835740|NCT04158804|Diagnostic Test|procalcitonin|accuracy of procalcitonin as a diagnostic marker in guiding antibiotic therapy in patients with a lower respiratory tract infection
15835741|NCT04158791|Procedure|pars plana vitrectomy with epimacular membrane removal and internal limiting membrane peeling|25-gauge pars plana vitrectomy with a solution of 0.15% trypan blue, 0.025% brilliant blue G, 4% polyethylene glycol (MembraneBlue Dual) assisted ERM/ILM removal performed by a single surgeon (GV); no air-fluid exchange was performed during surgery. In phakic eyes, phacoemulsification with intraocular lens implantation was performed at the time of vitrectomy.
15835742|NCT04158778|Drug|MDMA|Two sessions of MDMA-assisted psychotherapy will take place (session 3 & 7) within the 10 week course of psychotherapy. An initial dose of 125mg MDMA will be followed by an optional dose of 62.5mg 2 hours later.
15835743|NCT04158778|Other|Psychotherapy|Two sessions of MDMA-assisted psychotherapy will take place (session 3 & 7) within the 10 week course of psychotherapy.
15835744|NCT04158765|Other|DNeasy Tissue Kit (QIAGEN Inc., Mississauga, Ontario, Canada) and PCR- based assay (TRAPeze Telomerase Detection Kit; Millipore, Billerica, MA).|DNA will be extracted from sperm using the DNeasy Tissue Kit and Telomerase activity in samples will be measured using a PCR- based assay.
15835745|NCT04158752|Drug|Galcanezumab|Injection of study drug at 3 timepoints (day 30, day 60, day 90)
15835746|NCT04158739|Drug|Cytarabine|Given IT
15835747|NCT04158739|Biological|Flotetuzumab|Given IV
15835748|NCT04158726|Behavioral|modified Geriatric Assessment (mGA)|The mGA, administered via patient self-report on a touchscreen computer, as well as the real-time use and utility by clinicians and the correlation of mGA results on treatment decision-making.
15835749|NCT04158713|Drug|Intermittent Preventive Therapy with Dihydroartemisinin-Piperaquine|Monthly DP fixed dose of 3 tablets (40 mg of dihydroartemisinin and 320 mg of piperaquine) daily for three days until delivery. All participants will (continue to) receive daily cotrimoxazole (CTX) (one double-strength tablet of 160mg of sulfamethoxazole and 800mg of trimethoprim) and anti-retroviral drugs.
15835750|NCT04158700|Drug|LY3200882|LY3200882 administered orally
15835751|NCT04158700|Drug|Pembrolizumab|Pembrolizumab administered IV
15835752|NCT04158687|Drug|CTP-692|CTP-692 taken orally
15835753|NCT04158687|Drug|Placebo|Placebo taken orally
15835754|NCT04158674|Drug|Levosimendan|Levosimendan 2.5mg/ml, solution to be diluted for infusion Dilution in a 500ml bag of 5% Glucose The product is administered as a continuous infusion for 24 hours at an initial rate of 0.2 µg/kg/min
15835755|NCT04158674|Drug|Cernevit|mixture of 12 vitamins The dilution of the treatment is done in a 500ml bag of 5% Glucose The product is administered as a continuous infusion for 24 hours at an initial rate of 0.2 µg/kg/min
15835756|NCT04158661|Procedure|thymectomy (robotic-assisted thoracoscopic, minimally-invasive thymectomy)|preferring one unilateral access and placing three trocars between 3rd and 5th intercostal space in a triangular configuration, with a goal of an en bloc resection of all mediastinal tissue that could anatomically contain gross or microscopic thymus (or both).
15835757|NCT04158661|Procedure|thymectomy by means of median sternotomy (transsternal)|with a goal of an en bloc resection of all mediastinal tissue that could anatomically contain gross or microscopic thymus (or both).
15835758|NCT04158661|Procedure|no thymectomy (control)|routine medical care
15835770|NCT04158570|Procedure|Percutaneous Nephrolithotomy|"Application of different stone scoring systems :
~Guy's scoring system (GSS).
~Seoul renal stone complexity scoring system (S-ReSC).
~S.T.O.N.E. nephrolithometry scoring system.
~CROES Nomogram. These scoring systems will be applied on each patient and correlate the predictive values with the real results to know which one of the above scoring systems better predict the outcomes."
15835771|NCT04158531|Device|ECoG sensing and stimulation|Implant electrodes and a sensing+stimulation device, and use this for suppression of seizure activity
15835772|NCT04158518|Radiation|Toxicities reduced treatment|"Drug: docetaxel and cisplatin (Induction chemotherapy) Patients receive docetaxel (75 mg/m2 d1) and cisplatin (25mg/m2 d1-3) every 3 weeks for 3 cycles before IMRT.
~Omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR).
~Radiation: IMRT Intensity modulated-radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4 Gy to the primary tumor."
15835773|NCT04158518|Radiation|Conventional treatment|"Drug: docetaxel and cisplatin (Induction chemotherapy) Patients receive docetaxel (75 mg/m2 d1) and cisplatin (25mg/m2 d1-3) every 3 weeks for 3 cycles before IMRT.
~Concurrent cisplatin chemoradiotherapy delivered when responses to induction chemotherapy are less than 50% Partial Response(PR).
~Radiation: IMRT Intensity modulated-radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4 Gy to the primary tumor."
15835774|NCT04158505|Other|non-interventional|This prospective, observational study will be conducted according to each site's routine clinical practice
15835775|NCT04158492|Diagnostic Test|real-time multiplex PCR|Patients will be randomly assigned to receive experimental diagnosis (comprehensive molecular testing added to routine microbiological testing) AND standard diagnosis microbiological procedures
15835776|NCT04158492|Diagnostic Test|Standard diagnostic procedures|Patients who will undergo only the standard microbiological diagnostic procedures: blood cultures, Gram stain and culture sputum when possible, Gram and pleural fluid culture when appropriate, urine determination of the pneumococcal and Legionella pneumophila serogroup antigens type 1. A serological study will be carried out for the etiological agents of atypical pneumonia in the acute and convalescent phases of the infection.
15835777|NCT04158479|Device|ECMO|ECMO for circulatory and/or respiratory support
15835778|NCT04158466|Device|Kalifilcon A Daily Disposable Contact Lenses|Contact lens
15835779|NCT04158466|Device|Biotrue ONEday Daily Disposable Contact Lenses|Contact lens
15835780|NCT04158453|Drug|AUT00201|Oral dose of AUT00201
15835781|NCT04158453|Drug|Placebo|Oral dose of placebo
15835782|NCT04158440|Drug|4cycles(Toripalimab IV 240mg + platinum-based doublet chemotherapy)+13 cycles(Toripalimab IV 240mg); Biological: Toripalimab|Biological: Toripalimab 240 mg by IV infusion every 3 weeks (Q3W), given on cycle day 1;Drug: Cisplatin 75 mg/m^2 by IV infusion Q3W, given on cycle day 1;Drug: Corboplatin AUC 5 by IV infusion Q3W, given on cycle day 1;Drug: Pemetrexed 500 mg/m^2 by IV infusion Q3W, given on cycle day 1. Given only to participants with nonsquamous NSCLC.Drug:Paclitaxel 175 mg/m^2 by IV infusion Q3W;Drug:Docetaxel 60-75 mg/m^2 by IV infusion Q3W
15835783|NCT04158440|Drug|4cycles(Placebo + platinum-based doublet chemotherapy)+13 cycles(Placebo )|Biological: Placebo by IV infusion every 3 weeks (Q3W), given on cycle day 1;Drug: Cisplatin 75 mg/m^2 by IV infusion Q3W, given on cycle day 1;Drug: Corboplatin AUC 5 by IV infusion Q3W, given on cycle day 1;Drug: Pemetrexed 500 mg/m^2 by IV infusion Q3W, given on cycle day 1. Given only to participants with nonsquamous NSCLC.Drug:Paclitaxel 175 mg/m^2 by IV infusion Q3W;Drug:Docetaxel 60-75 mg/m^2 by IV infusion Q3W
15835784|NCT04158427|Procedure|Faecal transplantation|Faecal transplantation from a healthy donor via colonoscopy
15835785|NCT04158427|Procedure|Placebo faecal transplantation|Placebo faecal transplantation containing patient's own feces via colonoscopy
15835786|NCT04158414|Diagnostic Test|PET/MR scan|500 cancer patients referred to PET-CT assessment will undergo PET/MR scan as well, and the net data will be compared. The overall data will be investigated in groups and subgroups of patients that share similar clinical characteristics and represent cancer patients in different time points during the natural history of their disease. Data analysis will be performed both visually and quantitatively using different MR and PET parameters according to the patient group. Specific populations will be detailed in the next sections per malignancy.
15835787|NCT04158401|Device|Pregnolia|The Pregnolia measurement device (CE Mark for commercialization in the EU) will be used to measure the cervical stiffness (Pcl) on all subjects.
15835788|NCT04158388|Other|Mediterranean-diet enriched with a higher dose of tryptophan and magnesium|That gruop eaten at both breakfast and dinner from walnuts (3-5 units), as food with high values of tryptophan and magnesium
15835789|NCT04158388|Other|Isocaloric diet|That group eaten isocaloric diet plan based on Mediterranean diet.
15835790|NCT04158388|Other|Manual therapy|That group received moderate pressure digital manual therapy.
15835791|NCT04158388|Other|Placebo therapy|That group was treated with a US (in off mode) without conductive gel.
15835792|NCT04158375|Behavioral|Resistance Exercise|Resistance (RE) training will be performed 4 days per week using a combination of upper and lower body exercises at 8-12 repetitions per set. Participants will complete 2 progressing to 4 sets of 8 to 12 repetitions per exercise, with 1 minute rest between sets. Participants will warmup for 5 minutes on a treadmill, cycle ergometer or elliptical at ~50% VO2 peak then begin resistance training. Resistance will be performed 4 days per week with lower body exercise on Monday and Thursday, and upper body on Tuesday and Friday. Wednesdays are a rest day. Participants will begin at 2 sets per exercise on weeks 1 and 2, then 3 sets for week 3, and 4 sets for weeks 4 to 12.
15835793|NCT04158362|Drug|Paclitaxel injection|Paclitaxel is administrated at the dose of 80 mg/m² as a 1-hour intravenous infusion every week (i.e., D1, D8 and D15) of a 3-week cycle
15835794|NCT04158362|Drug|Capecitabine tablets|Capecitabine is given orally at a dose of 2000 to 2500 mg/m² daily for 14 days followed by a 7-day rest period every 3 weeks
15835795|NCT04158362|Drug|Letrozole 2.5mg|Letrozole is administered orally at 2.5 mg/day continuous for patients nonsteroidal aromatase inhibitor naïve or relapsing >1 year after the end of adjuvant endocrine therapy.
15835796|NCT04158362|Drug|Anastrozole 1mg|Anastrozole is administered orally at 1 mg/day continous for patients nonsteroidal aromatase inhibitor (NSAI) naïve or relapsing >1 year after the end of adjuvant endocrine therapy.
15835857|NCT04157933|Drug|009-A0|Inhaled placebo via Staccato aerosol, Dose 0 (placebo) each day for first 5 days, then 3 doses Dose 0 (placebo) q 2 hr on Day 6
15835797|NCT04158362|Drug|Fulvestrant Prefilled Syringe|Fulvestrant is administered at the dose of 500 mg intramuscular on D1-D15-D29 (as a loading dose), and then 500 mg every 28 days (as a maintenance dose) for patients relapsing on adjuvant or less than one year after completion of adjuvant NSAI.
15835798|NCT04158362|Drug|Abemaciclib|Oral 150 mg BID continuous
15835799|NCT04158349|Drug|Oxaliplatin|Subjects will be accrued in cohorts of 3 to 6 subjects per dose level starting at Dose Level 0 (85 mg/m2). Escalation will continue as described in the protocol until DLT stopping rules are met or the highest dose level is reached.
15835800|NCT04158349|Drug|mFOLFIRI|mFOLFIRI is a standardized chemotherapy regimen utilizing 5-fluorouracil, leucovorin, and irinotecan administered on day one of a 14-day cycle. 5-Fluorouracil, leucovorin, and irinotecan should be prepared and administered per the package insert and local institutional guidelines.
15835801|NCT04158336|Drug|ZN-c3|ZN-c3 is a study drug
15835802|NCT04158323|Device|Airway Management in patients with a anticipated difficult airway|survey of anesthesists and intensive care physician of the perfomans with the flexible endoscope in patients with a anticipated difficult airway
15835803|NCT04158297|Device|ESWL vs SOPIL|To compare the efficacy of single operator pancreatoscopy (SOP) with intracorporeal lithotripsy (SOPIL) to extracorporeal shock wave lithotripsy (ESWL) for the treatment of main pancreatic duct stones (MPDS) in patients with chronic pancreatitis.
15835804|NCT04158271|Device|Prone Position|In a randomized order we evaluate techniques for securing the airway in paralyzed patients in prone position
15835805|NCT04158271|Device|Laryngeal tube|In a randomized order we evaluate techniques for securing the airway in patients with a failed laryngeal tube
15835806|NCT04158271|Device|Endotracheal tube Leackage|In a randomized order we evaluate techniques for securing the airway in paralyzed patients with a endotracheal tube and a cuff leackage
15835813|NCT04158245|Drug|18F-fluciclovine PET Scan|The use of 18F-fluciclovine PET scanning will allow a more sensitive assessment of mCRPC patients at the initiation of systemic therapy and changes observed in 18F-fluciclovine PET will correlate better with the serologic changes in PSA, allowing superior disease monitoring, as compared to conventional imaging modalities. In addition, 18F-fluciclovine PET will detect heterogeneity in disease response and thus identify potential lesions amenable to targeted therapy.
15835814|NCT04158232|Other|Method|treatment of mature teeth with apical periodontitis
15835815|NCT04158219|Behavioral|Behavioral activation for health and depression (BA-HD)|Consistent with successful BA manuals, we plan to conduct up to 10 sessions of treatment over 12 weeks (the recommendation will be at least 8 sessions; scheduling of sessions will be flexible and conform to patient preference). The initial two sessions will be about 50 minutes long and later sessions will be 20-30 minutes long. Sessions can be done on site or over the phone; home visits will be offered for sessions 1-2 if a participant cannot travel. Treatment sessions will use behavioral activation techniques to assess participant values and link these values to behavior change. Goal-setting will focus on sequential, idiographic behavior change (tobacco use, medication adherence, physical activity, and diet) and be accompanied by educational materials and commercially available tools (e.g. activity trackers, pillboxes).
15835816|NCT04158206|Other|Maternal voice|Recording in the intensive care unit quiet and separate consultation room. For infants in the 'maternal voice group,' mothers were asked to tape what the mother wants to say to their babies and read of a child book from the independent publish, 'Xiao Qi's yellow persimmon' which talk about the mother who has a premature infants how to take caring of their baby. After reviewing the quality of the recording, the mother's voice recordings are compiled for 13 minutes with Sound Organizer. 2 , and the volume of the sound standard according to the American Academy of Pediatrics guidelines is 60 decibels in the incubator.
15835817|NCT04158193|Other|acupuncture|Subjects in acupuncture group will be received acupuncture treatment by inserting LI11, SJ5, SJ9, SJ13, SJ10, HT3, PC2, LI4, and LI15 on the affected limb and RN12, RN9, RN6, RN4, SP9, SP6. Needles will be remained for 30 minutes each time after DeQi sensation, one time a day，three times a week, the treatment will be lasted for 7 weeks.
15835818|NCT04158193|Other|sham acupuncture|"Subjects in control group will be treated with non-acupoint shallow needling, points will be selected 1 cm at the radial direction from acupoint LI11, SJ5, SJ9, SJ13, SJ10, LI4, HT3, PC2, LI4, LI15; 2 cm at the left of acupoint RN12, RN9, RN6, RN4; 1 cm at the tibial direction from SP9, SP6.
~The needling manipulation is the same as that of the acupuncture group, but only the superficial skin of points are punctured. The depth of needling is less than 0.5 cm, and no manipulation will be performed after puncturing the skin. Needles will be remained for 30 minutes each time,one time a day，three times a week, the treatment will be lasted for 7 weeks."
15835819|NCT04158180|Diagnostic Test|Questionnaire|A battery of questionnaires will be propose to the participants
15835820|NCT04158167|Drug|oxytocin|24 International units of oxytocin or palcebo will be given intranasally. The order of administration will be counterbalanced
15835858|NCT04157933|Drug|009-B1 (active --> placebo) crossover|Up to 2 doses (Dose 3) ; minimum of 2 hrs between doses, on Day 1, followed by Up to 2 doses (placebo) ; minimum of 2 hrs between doses, on Day 2
15835859|NCT04157933|Drug|009-B2 (placebo --> active) crossover|Up to 2 doses (placebo) ; minimum of 2 hrs between doses, on Day 1, followed by Up to 2 doses (Dose 3) ; minimum of 2 hrs between doses, on Day 2
15835821|NCT04158154|Other|Evidence-based hypertension treatment|The intervention has been adapted based on a local needs' assessment including exploration of health care workers and patient's knowledge, attitudes, and behaviors related to HTN, causes, consequences, and treatment. Implementation pathways have been developed with particular attention to overcoming modifiable barriers to HTN treatment and control across capability, intentional, and system domains using CFIR. Sites will randomly be assigned to receive either: Step 1 amlodipine 5mg; Step 2 amlodipine 5 mg + losartan 50 mg (as 2 separate pills); Step 3 amlodipine 10 mg + losartan 100 mg (as 4 separate pills); Step 4 amlodipine 10/losartan 100/HCTZ 25 (as 2 single pill combo) or Step 1 amlodipine 5mg; Step 2 amlodipine 5 mg + losartan 50 mg (as 1 single pill combo); Step 3 amlodipine 10 mg + losartan 100 mg (as 2 single pill combo); Step 4 amlodipine 10/losartan 100/HCTZ 25 (as 2 single pill combo).
15835822|NCT04158141|Drug|Carboplatin|Given IV
15835823|NCT04158141|Drug|Cisplatin|Given IV
15835824|NCT04158141|Procedure|Decortication|Undergo decortication
15835825|NCT04158141|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
15835826|NCT04158141|Drug|Pemetrexed|Given IV
15835827|NCT04158141|Drug|Pemetrexed Disodium|Given IV
15835828|NCT04158141|Radiation|Pencil Beam Scanning|Undergo PBS
15835829|NCT04158141|Procedure|Pleurectomy|Undergo pleurectomy
15835830|NCT04158141|Other|Quality-of-Life Assessment|Ancillary studies
15835831|NCT04158141|Other|Questionnaire Administration|Ancillary studies
15835832|NCT04158128|Other|non-intervention|non-interventional, prospective cohort study
15835833|NCT04158115|Other|Entire Spine Mobilization|8 sessions of Following: -Entire Spinal Mobilization of all spinal segment from C0 to C1 to L5 to S1 (10 reps × 3 sets), - Moist heat: 10 to 15 minutes, - Soft tissue Mobilization, - Exercises : (Knee to chest, Bridging. Hamstrings Stretching, TA stretching)
15835834|NCT04158115|Other|Segmental Mobilization|"8 sessions of following -Segmental Mobilization: All lumbar segment from L1 to L2 to L5 to S1 (10 reps × 3 sets) - Moist heat: (10 to 15 minutes), -Soft tissue Mobilization
~- Exercises: (Knee to chest, Bridging. Hamstrings Stretching, TA stretching)"
15835835|NCT04158102|Drug|Bupivacaine liposome injectable suspension|Single dose of Bupivacaine liposome injectable suspension 266 mg in 20 mL
15835836|NCT04158089|Behavioral|Babies and Moms connected through Love, Openness, and Opportunity (BLOOM)|"Participants will be randomly assigned into one of two groups for the BLOOM intervention; the control group will receive treatment as usual. Participants assigned to the treatment group will receive texted attachment exercises to complete from home. The intervention will take place over a 2-week period. Participants in the Attachment Exercises group will receive a text every day with an activity designed to increase feelings of attachment (e.g., read a children's book; sign a nursery rhyme; picture giving your baby a baby; tell your baby a story, etc.)."
15835837|NCT04158076|Drug|Ezetimibe/Rosuvastatin|PO, Once daily(QD), 8weeks
15835838|NCT04158076|Drug|Telmisartan|PO, Once daily(QD), 8weeks
15835839|NCT04158076|Drug|Telmisartan/Amlodipine 80 Mg-5 Mg ORAL TABLET|PO, Once daily(QD), 8weeks
15835840|NCT04158063|Behavioral|Dual Task Training|"In total 12 Dual Task conditions will be performed in which 3 cognitive tasks are combined with 4 motor tasks:
~Cognitive tasks:
~Titrated digit span backwards
~Auditory vigilance with alphabets
~Subtracting by 7
~Motor tasks:
~Walking at self-selected speed
~Walking while carrying a cup of water
~Walking while stepping over obstacles
~Walking crisscross"
15835841|NCT04158063|Other|Single Mobility Training|standard routine training
15835842|NCT04158050|Drug|IL5 Antagonist or anti-IL5R-antibody or Omalizumab|mepolizumab, reslizumab, benralizumab and omalizumab in severe asthma
15835843|NCT04158037|Behavioral|mHealth App|The app uses smartphones' global positioning software (GPS) that recognizes a user's location to within 15 feet. The app will construct a customizable geofence (e.g., 3 miles) around a gambler's favored gambling venue (e.g., casino, gas station). If the individual crosses the fence boundary his or her phone will raise the alarm with a personalized motivational message.
15835844|NCT04158024|Other|Erector Spinae Plane Block|The ESPB is a fascial plane block performed by injecting local anesthetic between the erector spinae muscle and the transverse process. Its proposed mechanism of action is via blockade of the dorsal and ventral rami of the thoracic spinal nerves and sympathetic fibers.
15835845|NCT04157998|Drug|normal saline|intrvenous administration of 10ml normal saline preoperative
15835846|NCT04157998|Drug|Metoclopramide 10mg|intrvenous administration of 10mg metoclopramide diluted in 10ml normal saline preoperative
15835847|NCT04157985|Drug|Continue PD-1/PD-L1 Inhibitors treatment|Continued treatment with PD-1/PD-L1-1 inhibitor
15835848|NCT04157985|Other|Discontinue PD-1/PD-L1-1 inhibitor|Discontinued treatment with PD-1/PD-L1-1 inhibitor
15835849|NCT04157972|Device|SIMEOX|SIMEOX is a device generating a succession of gentle depression at the mouth.
15835850|NCT04157972|Device|PEP|A PEP device (Pari-PEP) will be used to provoke a positive expiratory pressure while exhaling, thereby stabilizing the airways during expiration.
15835851|NCT04157959|Drug|SHR4640 dose1|Tablet,dose1,QD
15835852|NCT04157959|Drug|Febuxostat dose2|Tablet,dose2,QD
15835853|NCT04157946|Diagnostic Test|CT|"Patients with ARDS were included. We excluded patients with emphysema, asthma, pneumothorax, or serious conditions of instability: oxygen saturation ≤ 88%; severe shock, ventricular arrhythmia, or myocardial ischemia.
~To allow comparison between groups, patients were ventilated in volume control under similar conditions of tidal volume (TV; 6 ml/kg-PBW), plateau pressure (PPlat 30 cmH2O), respiratory rate (18 bit/min) and constant flow. PEEP was adjusted to reach objective PPlat.
~Transpulmonary pressures (TP) were measured and a chest CT scan performed during an expiratory and inspiratory pause. Global and regional volumes of lungs were measured using specific software (Volume Analysis Software,Toshiba, Japan). Three regions were identified: basal (from the diaphragm to the carina), middle (from the carina to the aortic arch) and apical (above the aortic arch)."
15835854|NCT04157933|Drug|009-A1|Inhaled apomorphine via Staccato aerosol, Dose 1 (low dose) each day for first 5 days, then 3 doses Dose 1 (low dose) q 2 hr on Day 6
15835855|NCT04157933|Drug|009-A2|Inhaled apomorphine via Staccato aerosol, Dose 2 (middle dose) each day for first 5 days, then 3 doses Dose 2 (middle dose) q 2 hr on Day 6
15835856|NCT04157933|Drug|009-A3|Inhaled apomorphine via Staccato aerosol, Dose 3 (high dose) each day for first 5 days, then 3 doses Dose 3 (high dose) q 2 hr on Day 6
15835883|NCT04157751|Drug|Placebo to Empagliflozin|Film-coated tablet
15835860|NCT04157920|Device|Transcatheter Aortic Valve Implantation with ACURATE NEO/TF|Transcatheter implantation of the heart valve device ACURATE NEO/TF in patients suffering from severe aortic stenosis and are candidates for this operation
15835861|NCT04157920|Device|Transcatheter Aortic Valve Implantation with Medtronic Evolut R/Pro|Transcatheter implantation of the heart valve device Medtronic Evolut R/Pro in patients suffering from severe aortic stenosis and are candidates for this operation
15835862|NCT04157907|Behavioral|Mentalization based therapy|Mentalization based therapy is a specialized treatment for patients with borderline personality disorder. The treatment program combines individual and group therapy, as well as psychoeducation
15835863|NCT04157894|Other|Standard long-lasting insecticidal net|Interceptor® (BASF) contains a pyrethroid insecticide
15835864|NCT04157894|Other|Chlorfenapyr insecticide treated net|Interceptor® G2 (BASF) is an ITN containing two active ingredients: Alpha-cypermethrin, a pyrethroid insecticide, and chlorfenapyr, a pyrrole insecticide.
15835865|NCT04157894|Other|Piperonyl butoxide long-lasting insecticidal net|PermaNet®3.0 (Vestergaard) contains deltamethrin, a pyrethroid insecticide, and piperonyl butoxide, an insecticide synergist.
15835866|NCT04157881|Drug|RABEprazole 20 Mg Oral Delayed Release Tablet|Absorption of APO-Dabigatran measured with and without influence of rabeprazole
15835867|NCT04157881|Drug|APO-Dabigatran 150mg|Absorption of APO-Dabigatran post single dose
15835868|NCT04157868|Drug|rhBNP|rhBNP intra-coronary injection 1.5 ug/kg loading dose, with intravenous injection 0.0075-0.01 ug/kg/min persistent for 72 hour.
15835869|NCT04157868|Drug|Control|Saline intra-coronary injection 0.15ml/kg loading dose, with same intravenous injection speed for 72 hour.
15835870|NCT04157855|Procedure|Abdominal Plane Block(s) with depot Steroids|APB Steroids treatment: under real time ultrasound guidance, a 100 mm needle is introduced into the specified plane (subcostal TAP for upper abdomen pain, posterior TAP for lower abdomen pain or TQL for flank and lower abdominal pain). Normal saline (10 ml) is used to open the fascial plane (saline hydrodissection). Then 40 mg of depomedrone diluted in 10 ml of 0.25% levo-bupivacaine is injected into the plane. . A total of 80 mg of depomedrone (steroid) will be used.
15835871|NCT04157842|Procedure|total hip replacement with subtrochanteral osteotomy|applying subtrochanteral osteotomy during the operation to release the tension of vessels and nerve
15835872|NCT04157842|Procedure|total hip replacement with no osteotomy|just total hip replacement
15835873|NCT04157829|Device|Scintilling lamp|Lamp with a standardized scintilling
15835874|NCT04157829|Device|Classic lamp|Lamp without a scintilling
15835875|NCT04157816|Other|Face-to-Face Training|This intervention is a traditional classroom-based (face-to-face) training program for non-specialist health workers offering instruction for the delivery of the Healthy Activity Program (HAP) in primary care settings. HAP is an evidence-based brief psychological treatment for depression. The classroom instruction follows the HAP manuals and is facilitated by an experienced counselor with certification as a Master Trainer, meaning that they have significant experience delivering HAP to patients with depression in clinical settings and also training other health workers in the delivery HAP. The total duration of classroom instruction is 6 days.
15835876|NCT04157816|Other|Digital Training|This 4-week digital training program for non-specialist health workers is accessed through a smart phone app and offers instruction in the delivery of the Healthy Activity Program (HAP) in primary care settings. HAP is an evidence-based brief psychological treatment for depression. The digital training covers the same content as the Face-to-Face training. The course includes 16 modules with video lectures, role-play videos, graphics, slide presentations, quizzes, and assessment questions. Participants also receive low-intensity support to enhance their learning experience and sustain engagement, including: 1) access to an automated 'Help Line' that participants can call any time with questions about the program; 2) weekly automated messages sent through the mobile app to encourage participants; and 3) automated messages and phone calls to participants who show prolonged periods of inactivity in the mobile app to offer technical support and help them complete the training program.
15835877|NCT04157816|Other|Coaching Support|Individualized remote coaching is a form of high-intensity support that will be used to help sustain participant engagement in the digital training program and promote success in progressing through the course. Each week, a Coach will phone participants and offer encouragement and support related to the course. The phone call will last no more than 60 minutes. The Coach will be someone who has successfully completed the course, and therefore can offer first hand knowledge of the content. During the coaching session, the coach will review the participants' progress through the course, offer praise and encouragement, discuss any challenges or questions related to the course content, and review the participants' goals and plans for the upcoming week. Each participant will receive a maximum of 4 remote coaching sessions (1 per week over the 4-week training program).
15835878|NCT04157803|Diagnostic Test|Acetic acid % spray|"If during a videcolonoscopy a polyp is found with suspicion of tubular, tubulovillious or Serrated adenoma, the endoscopist will proceed to stain it using diffuser and acetic acid at a concentration of 3%. The presence or not of the aceto-whitening reaction will be evaluated, understanding it as the persistence of white staining of the polyp at one minute or three minutes, standing out from the surrounding mucosa.
~In case of positive staining it will be considered homogeneous if the staining is uniform on the surface of the polyp or heterogeneous if it is done irregularly."
15835879|NCT04157790|Other|CARE score|CARE score calculation
15835880|NCT04157777|Other|Perineum massage with olive oil|"Descriptive form used for data collection included questions about women's sociodemographic features, medical and obstetric history and previous and present birthsof women participated in the study.
~The Reeda Scale The scale is consisted of five parameters of healing: Redness, Edema, Ecchymosis, Discharge Approximation.
~Pregnant women who came to the delivery room and met the criteria were randomly selected and assigned to experimental and control group according to age and educational status.
~There was not any change in the birth process of the delivery room during data collection and the pregnant women received routine care and treatments.
~REEDA scale was administered by other midwives who worked at the puerperal room where pregnant women stayed after birth and did not know their groups because those who gave vaginal birth were early discharged from the hospital as they could answer only the first three parameters of REEDA scale."
15835881|NCT04157764|Device|HomeChoice Claria APD machine with SHARESOURCE|HomeChoice Claria APD machine with SHARESOURCE software. SHARESOURCE is a software can telemonitor patients' compliance
15835882|NCT04157751|Drug|Empagliflozin|Film-coated tablet
15835884|NCT04157738|Drug|Rapid-Acting Insulin|Prior to discharge, all subjects will receive a regimen that includes a Meal-time insulin and carbohydrate regimen (number of units of insulin, number of carbohydrates, and/or ICR)
15835885|NCT04157738|Drug|Long acting insulin|Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)
15835886|NCT04157725|Drug|mild stimulation protocol: oral Clomiphene Citrate|Group A (mild stimulation protocol) will receive oral Clomiphene Citrate (Clomid®) 150 mg/day for 5 days (starting on the 2nd of menses), followed by FSH/HMG (human menopausal gonadotropins) at a daily dose of 150-225 IU starting from the 6th day of the menstrual cycle. GnRH antagonist (Cetrotide®, Merck-Serono, Switzerland) 0.25 mg subcutaneously daily will be started once a dominant follicle becomes ≥14 mm until the day of final follicle maturation. Once 3 leading follicles reach 18mm in diameter, final follicle maturation will be triggered using HCG (Choriomon® 10,000 IU) in the presence of 14 or less pre-ovulatory follicles or GnRH agonist (Triptorelin-Gonapeptyl® 0.3mg single dose) in the presence of 15 or more follicles. The choice of the starting FSH/HMG daily dose will be tailored to BMI: 150 IU/d for BMI less than 25 and 225IU/d for BMI 25 and above.
15835887|NCT04157725|Drug|Conventional Stimulation Protocol: will receive FSH/HMG|Group B (conventional stimulation protocol) will receive FSH/HMG (human menopausal gonadotropins) at a daily dose of 150-225 IU starting on the 2nd day of menses. GnRH antagonist (Cetrotide®, Merck-Serono, Switzerland) 0.25 mg subcutaneously daily will be started once a dominant follicle becomes ≥14 mm until the day of final follicle maturation. Once 3 leading follicles reach 18mm in diameter, final follicle maturation will be triggered using HCG (Choriomon® 10,000 IU) in the presence of 14 or less pre-ovulatory follicles or GnRH agonist (Triptorelin-Gonapeptyl® 0.3mg single dose) in the presence of 15 or more follicles. The choice of the starting FSH/HMG daily dose will be tailored to BMI: 150 IU/d for BMI less than 25 and 225IU/d for BMI 25 and above.
15835888|NCT04157712|Drug|ALZ-801 or matching placebo|
15835889|NCT04157699|Drug|TDF tablet|TDF tablet 300mg QD
15835890|NCT04157699|Drug|QL-007|QL-007 tablet
15835891|NCT04157686|Drug|MT10109L|MT10109L will be injected into either the GL, LCL, or both the LCL and GL.
15835892|NCT04157673|Behavioral|Episodic Future Thinking introduced at 6 weeks|This intervention involves participants engaging in episodic future thinking in order to improve their medication adherence and overall prospective thinking ability. This intervention will be introduced following a 6-week baseline period.
15835893|NCT04157673|Behavioral|Episodic Future Thinking introduced at 8 weeks|This intervention involves participants engaging in episodic future thinking in order to improve their medication adherence and overall prospective thinking ability. This intervention will be introduced following a 8-week baseline period.
15835894|NCT04157673|Behavioral|Episodic Future Thinking introduced at 10 weeks|This intervention involves participants engaging in episodic future thinking in order to improve their medication adherence and overall prospective thinking ability. This intervention will be introduced following a 10-week baseline period.
15835895|NCT04157660|Procedure|Oxygen application|Oxygen application Supplemental oxygen via mask
15835896|NCT04157660|Procedure|Sham room air|Room air will be applied via mask
15835897|NCT04157647|Device|CytoSorb|The hemadsorption filter will be included in the CPB circuit between the oxygenator and the venous reservoir. After cardiac surgery, the use of the filter will be continued till 24 hours after the end of surgery.
15835898|NCT04157647|Device|Control|No hemadsorption filter or other treatment will be included in the CPB circuit
15835899|NCT04157634|Diagnostic Test|Prognostication model|In a prospective cohort of children hospitalized in a PICU, developement a model based on biomarkers, HRV, and a computerized classifier output, to predict long-term neurological outcome after a moderate or severe TBI in children aged 0 to 18 years.
15835900|NCT04157621|Device|Active taVNS|Patients will be masked to transcutaneous stimulation of the auricular branch of the vagus nerve at the tragus
15835901|NCT04157621|Device|Sham Stimulation|Sham stimulation involves identical perceptual threshold finding and stimulation parameters as active stimulation, with the exception of stimulation target. Sham stimulation will be delivered to the left earlobe, a target believed to have little to no vagal nerve innervation.
15835902|NCT04157608|Device|Habitual Prosthesis|Habitual baseline prosthesis prescribed by participant's clinician.
15835903|NCT04157608|Device|Energy-Harvesting Mesofluidic Impulse Prosthesis|e-MIP is an experimental lower limb ankle-foot prosthesis.
15835904|NCT04157595|Other|Reproductive Genetic Carrier Screening|Carrier screening for approximately 1300 genes associated with severe autosomal recessive and X-linked recessive conditions affecting children will be performed on each member of the couple. A combined result will be issued indicating whether the couple has a 'low' or 'increased' risk of having a child with a genetic condition
15835905|NCT04157582|Other|Pilates training|"Pilates warm-up training (5 minutes) consisted of Breathing, the Chest stretch, the Toy soldier, Upper extremity PNF patterns, and Roll down.
~Pilates mat training performed in 5 different positions (30 minutes).
~One leg stretch, Hundreds, the Double leg stretch, Scissors, the Shoulder bridge, Oblique preparation, and the Hip twist were performed in the supine position(Fig.7).
~Clare, the Side kick, Arm openings, the Lower lift, Leg lifts, and the Side bend were performed in the side-lying position.
~Swan dive, the One leg kick, Swimming, the Breast stroke preparations, the Breast stroke performed in the prone position(Fig.8).
~Half roll back, Oblique roll up were performed in the sitting position.
~Swimming was performed in the kneeling position.
~The Pilates cool down training (5 minutes) were the Spine stretch, Saw, Chest stretch, Toy soldier. (Cruz et al .,2011)"
15835906|NCT04157582|Other|Conventional physical therapy|"Gentle manual stretching exercises for (elbow flexors, wrist flexors , hamstring and calf muscle).
~Strengthening Exercises for ( elbow extensors, wrist extensors and dorsiflexors)
~Balance training (Wobble board training) :
~Patient will stand on squared then circled wobble board while it moves within parallel bars in front of mirror with hand support(with repetition 10times)
~Patient will stand on squared then circled wobble board while it moves within parallel bars in front of mirror without hand support(with repetition 10times)."
15835947|NCT04157244|Behavioral|Tailored music listening intervention|The music intervention consists of listening to preferred soothing music at bedtime for 30 minutes every night for four weeks (28 sessions total). This theory based caregiver-assisted intervention builds on the evidence-based protocol of using individualized music to decrease agitation in nursing home residents. It also accounts for sleep-inducing properties of music.
15835907|NCT04157556|Other|Yo-Yo Intermittent Recovery Test Level 1|"The test is a standard test battery with progressively increasing speeds. After every 40-m run (2x20 m), active rest is performed by walking or jogging at a distance of 10 m (2x5 m). for 10 seconds. Participants are trying to adjust their speed according to incoming audio signals.The test is terminated when the participants can not reach the signal twice. The test ends in 10-20 minutes depending on the level of participants.
~Reference Bangsbo, J., Iaia, F. M., & Krustrup, P. (2008). The Yo-Yo intermittent recovery test. Sports medicine, 38(1), 37-51.
~Krustrup, P., Mohr, M., Amstrup, T., Rysgaard, T., Johansen, J., Steensberg, A., ... & Bangsbo, J. (2003). The yo-yo intermittent recovery test: physiological response, reliability, and validity. Medicine & Science in Sports & Exercise, 35(4), 697-705."
15835908|NCT04157543|Other|electroacupuncture|acupuncture with electricity
15835909|NCT04157530|Device|wang-bu-liu-xing|wang-bu-liu-xing applied on the surface of Jinming and Qiuhou acupoints
15835910|NCT04157530|Device|acupuncture|acupuncture applied to Qingming and Qiuhou with Der-qi
15835911|NCT04157530|Device|Electroacupuncture|acupuncture, but the needles of Qinming and Qiuhou connected to the electroacupuncture machine after Der-qi, the frequencies of stimulus were 6 Hz, the intensity of stimulus was minimal visible muscle twitch
15835914|NCT04157504|Other|Physical function assessment|Physical function assessment is a tool to evaluate mobility levels of patients
15835915|NCT04157491|Drug|anlotinib and anti PD-1 antibody|Anti-PD-1 antibody administered by intravenous (IV) infusion on Day 1 of each 21-day cycle plus Anlotinib 12 mg administered orally (PO) once daily (QD) Day1-Day14 during each 21-day cycle.
15835916|NCT04157478|Drug|Anlotinib Hydrochloride|Anlotinib hydrochloride will be given with a daily dose of 12 mg for 14 days of a 21-day cycle up to 2 cycles, initiated on the first day of radiation therapy and followed by adjuvant treatment with the same dosing schedule until patients have disease progression or intolerable toxicities.
15835917|NCT04157478|Radiation|Radiation therapy|Radiation therapy will be delivered in daily fractions of 2 Gy given 5 days a week for a total of 60 Gy.
15835918|NCT04157478|Drug|Temozolomide|Temozolomide will be administered at a daily dose of 75 mg/m2 until the completion of radiation therapy. Four weeks after the completion of radiation therapy, patients will be given with adjuvant chemotherapy with temozolomide at a dose of 150-200 mg/m2 for 5 days of a 28-day cycle for a total of 6 cycles.
15835919|NCT04157465|Other|Treatment strategy trial|"Participants will be randomly allocated in a 1:1 ratio after meeting eligibility criteria to either early empiric or pre-emptive strategy of treatment with antifungals. The antifungal treatment initiation will be at the time of allocation in the empiric group. The treatment initiation rules in the pre-emptive group will include
~Fungal Biomarkers positivity (Beta-D Glucan>150 pg/ml, Galactomannan index>1.0)
~Mycological evidence of fungal infection on fungal cultures from a non-sterile site
~Radiological evidence of fungal infection
~Other Investigations suggestive of fungal infection viz. endophthalmitis, vegetations suspicious of fungal infection, Vegetations on echocardiography with negative blood cultures for bacteria that is non-responsive to appropriate antibiotics, refractory culture-negative spontaneous bacterial peritonitis
~Treatment duration will be guided by serum biomarkers (BDG and GM) and fungal cultures."
15835920|NCT04157452|Procedure|flexible ureteroscopy|flexible ureteroscopy is used to removed the stone. If a double-J stent was inserted pre-operatively, it was removed at the beginning of surgery. Rigid ureteroscopy was routinely used for ureteral dilatation before fURS. A 0.035 mm guidewire was advanced through the urethral and ureteral meatuses to the renal pelvis under direct rigid ureteroscope vision. A 14-Fr ureteral access sheath (Cook Medical, Bloomington, IN) was then passed over the wire to the ureteropelvic junction, and 7.5-Fr fURS (Flex-X2, Karl Storz, Germany) was performed through the sheath. Intrarenal pressure was stabilized by a pressure-sensitive pump (Shenda Medical, China). Holmium: yttrium-aluminum-garnet laser was used to fragment the stones. After lithotripsy, 6-Fr double-J stent was routinely inserted in all cases for 2-4 weeks.
15835921|NCT04157439|Other|Control Group|"Hot fermentation was applied for 10 mints Sustain pressure on trigger point was applied with thumb for 3secs hold and 2 sec release (till pain is reduced).
~Self-stretches of cervical muscles (10 reps× 1set) For home plan cervical muscles stretching and postural care was guided"
15835922|NCT04157439|Other|Experimental Group|"Hot fermentation was applied for 10 mints. Integrated Neuromuscular Inhibition Technique [sustain pressure, Post Isometric Relaxation (PIR) and SCS]. Sustain pressure was applied on trigger points using thumb for 3 sec hold and 2 mints release (till pain is reduced).
~Post isometric stretch (MET) was given with 4 repetitions (6-10sec hold). Strain counter strain was given in which upper trapezius shortened position was maintained by slight flexion, same side bending, opposite rotation and shoulder abduction for 90 sec and repeats this procedure till the pain is reduced to 3 out of 10.
~Self-stretches for cervical muscles were done at the end of session to maintain the gained ranges (10 reps×1 set) For home plan cervical muscles stretching and postural care was guided"
15835923|NCT04157426|Other|Percutaneous electrolysis|Ultrasound-guided percutaneous electrolysis in the active myofascial trigger point of the levator scapulae muscle
15835924|NCT04157426|Other|Dry needling|Ultrasound-guided dry needling the active myofascial trigger point of the levator scapulae muscle
15835925|NCT04157400|Device|Intraoperative Parameter Testing|"Step 1: Recording and stimulation of spinal potentials during insertion of epidural spinal stimulator paddle
~Once the epidural paddle is placed, study procedures will begin by connecting the terminals of the paddle to an electrophysiological recording device for signal amplification and filtering. Using this recording setup, motor evoked potential (MEP) and somatosensory evoked potential (SSEP) protocols will be performed to determine motor and sensory thresholds, respectively. Next, the surgical procedure will resume and after the implantable pulse generator (IPG) has been placed, study procedures will begin again and include activation of both low-frequency tonic stimulation (LFTS) and high-frequency burst stimulation (HFBS) patterns from the inserted paddle while recording EMG signals."
15836004|NCT04156789|Diagnostic Test|Home sleep apnea testing|Sarcoidosis patients and control subjects will undergo one night of home sleep apnea testing using ApnoeaLinkTM Plus device (ResMed Corporation, Poway, Calif). The device records the patient's nasal respiratory pressure signal as a surrogate of nasal flow, respiratory movements by a thoracic impedance belt, and finger pulse oximetry. The results of the sleep study will be scored automatically with dedicated software (ResMed Corporation, Poway, Calif), and manually reviewed to ensure data accuracy.
15835926|NCT04157400|Device|Proprioception Testing During Stimulation|"Step 3: Proprioception testing
~The research team will investigate the perceived change in knee joint angle and direction of movement reported by the subject in a Threshold to Detect Passive Movement (TTDPM). The TTDPM protocol will begin with the subject sitting in the Biodex testing seat, with the non-tested leg hanging freely and the tested leg strapped to the rotating arm of the dynamometer at the lower shank. The subject will be blinded as to the mode and intensity of stimulation: HFBS, LFTS, or no stim. The TTDPM will consist of at least 10 trials for each stimulation condition chosen based on SCM outcomes. The subject has control of a kill-switch that immediately halts movement of the rotating arm, which is to be activated once the subject perceives movement OR if the subject begins to feel any pain or discomfort throughout the task."
15835927|NCT04157400|Device|Gait Analysis During Stimulation|"Step 4: Body weight support and treadmill (BWST) testing
~Similar to step 2, LFTS and HFBS patterns will be compared by systematically testing each individual contact on the paddle while investigating for changes in stepping speed, pattern and EMG moduling complexity. Regarding EMG module analysis, muscle activity will be recorded bilaterally via surface EMG from lower extremity musculature. Furthermore, subjects will also have active LED markers placed over their clothes in order to track whole body kinematics throughout this portion of the study.
~To optimize capture of steady state data on the treadmill, each subject will walk for approximately 10 sec prior to the 30 sec of data collection (40 sec per trial). This will allow capture of at least 10 consecutive steady state gait cycles (depending on cadence) per each amplitude selection for each stimulation delivery technique, which will be defined by parameters found during walking SCM."
15835928|NCT04157387|Other|Cyriax inferior capsular stretching + Manual Therapy|Electro-therapy 10mins Manual therapy : Kalternbon grade 1 and 2 Mobilization : Inferior glide (10x3), posterior glide, (10 reps x 3 sets), anterior glide (10 reps x 3 sets), Active ROM exercises : 10 reps x 3 sets Home plan include :, wall walking exercises, pendulum exercises ,towel stretch exercises, Cross Body Adduction (10reps x 2 sets ,each) Cyriax inferior capsular stretching
15835929|NCT04157387|Other|Manual therapy|"Before starting capsule stretching technique, Analgesic short-wave diathermy may be given for 10 minutes.
~Kalternbon grade 1 and 2 Mobilization : Inferior glide (10x3), posterior glide, (10 reps x 3 sets), anterior glide (10 reps x 3 sets), Home plan include :, wall walking exercises, pendulum exercises ,towel stretch exercises, Cross Body Adduction (10reps x 2 sets ,each)"
15835930|NCT04157374|Other|Action Observation training|They have to watch a video showing a person carrying out exercises (12 exercises: 3 of stretching, 3 of core stability, 3 of mobilization and 3 of functional). then they have to practice them. The observation of the exercises and their performance last 8 minutes (4 minutes for observation and 4 minutes for practice). They have to repeat the exercises 5 times per week for 3 weeks.
15835931|NCT04157374|Other|Active Exercises|Execution of exercises: 3 of stretching, 3 of core stability, 3 of mobilization and 3 of functional activity. Patients of the control group recieve a brochure with the same exercises the patients of the experimental group received through the video. They will be asked to read the exercise 3 times and to practice it for 4 minutes. They have to repeat the exercises 5 times per week for 3 weeks.
15835932|NCT04157361|Diagnostic Test|Collection of breath condensate|Breath condensate will be collected from the patients involved in study.
15835933|NCT04157348|Biological|Benralizumab|30 mg/mL solution for injection in a single accessorized prefilled syringe (APFS) will be administered subcutaneously (SC)
15835934|NCT04157348|Biological|Mepolizumab|3x100 mg vials of powder for solution for injection reconstituted into 3 separate 1 mL syringes for administration on each dosing occasion. Injection volume per syringe is 1 mL. Mepolizumab active solution will be administered subcutaneously (SC)
15835935|NCT04157348|Biological|Placebo to Mepolizumab|Matching placebo: 0.9% sodium chloride, solutions for injection in 1mL syringes (3 syringes will be used on each dosing occasion). Injection volume per syringe is 1mL. Placebo to Mepolizumban will be administered subcutaneously (SC)
15835936|NCT04157348|Biological|Placebo to Benralizumab|Matching placebo solution for injection in APFS, 1 mL fill volume. Placebo solution will be administered subcutaneously (SC)
15835937|NCT04157335|Biological|Benralizumab 30 mg|"Benralizumab is 30 mg/ml solution for injection in accessorized pre-filled syringe, 1 ml fill volume.
~Benralizumab 30 mg subcutaneously will be injected every 4 weeks for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks thereafter (Weeks 16, 24, 32, 40 and 48)."
15835938|NCT04157335|Biological|Matched placebo|"Matching placebo solution for injection in accessorized pre-filled syringe. 1 ml fill volume.
~Matching placebo subcutaneously will be injected every 4 weeks for the first 3 doses (Weeks 0, 4 and 8) and every 8 weeks thereafter (Weeks 16, 24, 32, 40 and 48)."
15835939|NCT04157322|Diagnostic Test|prospective single arm biomarker (plasma cell-free DNA hydroxymethylation) study|Blood draw
15835940|NCT04157296|Behavioral|Cognitive behavioral therapy (CBT)|The CBT intervention will consist of 12 weekly 60 minute sessions of the manualized therapy, adapted from the Coping Cat program, for the treatment of pediatric anxiety disorders.
15835941|NCT04157296|Behavioral|computerized cognitive training (CCT)|CCT intervention will consist of approximately 30 minutes of CCT games prior to each CBT session, to engage cognitive control capacity prior to receipt of CBT. The CCT games will be designed to target focused attention, response inhibition, working memory and multiple simultaneous attention to constitute a general executive function training, and activate neural systems associated with executive function/cognitive control. Difficulty of the games will be titrated individually and by session to avoid boredom and progressively activate the functional systems underlying cognitive control.
15835942|NCT04157283|Diagnostic Test|MRI brain, visual evoked potential, Cerebrospinal Fluid, Sexual dysfunction measure, Depressive symptoms assessment and Multiple Sclerosis Quality of Life-54(MSQOL-54)|"Neurophysiological Evaluation:
~Visual Evoked Potential (VEP).
~Imaging Evaluation:
~Conventional MRI.
~Cerebrospinal Fluid (CSF):
~Sexual dysfunction measure: through the international index of erectile function (IIEF), female sexual function questionnaire (SFQ) and the sexual Quality of life male and female version (SQoL) (American Psychiatric Association, 1994).
~Depressive symptoms assessment through The BDI (The Beck Depression Inventory) which is the most common instrument measuring the severity of depression.
~Fatigue symptoms were evaluated through fatigue subscale of Multiple Sclerosis Quality of Life-54(MSQOL-54)."
15835943|NCT04157270|Device|Penumbra System|Penumbra System
15835944|NCT04157257|Drug|TDF tablet|TDF tablet 300mg QD
15835945|NCT04157257|Drug|Entecavir Tablet|Entecavir tablet 0.5mg QD
15835946|NCT04157257|Drug|QL-007|QL-007 tablets 200mg BID
15835948|NCT04157231|Other|Acute stroke care Intervention arm|"Training and education of the site staff about the treatment protocol for the different components of the management plan will be provided on two occasions. The aim of these sessions will be to educate stroke champions and other site staff on the management protocols. Available training resources will be accessed (including online materials) and simulation training will be used. New skills such as dysphagia assessment will be emphasized based on existing knowledge and competencies. After training, staff will have another assessment (Post-test) in order to determine whether they have been adequately trained and are able to adhere to the essential acute stroke care management plan. A standardised Power Point presentation and accompanying handouts will be made available for further use in the ward.
~Refresher training will be provided monthly during the intervention."
15835949|NCT04157218|Device|HIFU device (Doublo, HIRONIC Co., Sungnam, Korea)|The areas treated with HIFU will include: The forehead, temples, and malar area, cheeks and submental area .
15835950|NCT04157218|Device|Threads used in this study are absorbable Aptos|The threads will be inserted to the cheeks
15835951|NCT04157205|Diagnostic Test|Non-invasive ECG imaging - CardioInsight test|"Consent session
~Fitting of ECGi vest and CT scan of the chest
~Supervised exercise test and Valsalva maneuvre
~Programmed stimulation via ICD (selected participants)
~Blood tests - genetics"
15835952|NCT04157192|Other|Real acupuncture|The patient will be treated for migraine with real acupuncture.
15835953|NCT04157192|Other|Sham acupuncture (placebo group)|Sham acupuncture is used as a control in scientific studies to test the efficacy of acupuncture in the treatment of various disorders, in this case, migraine. In this study, the subjects will not know whether they are getting true acupuncture or not. In the placebo group, the acupuncture needles will not actually be inserted into the skin. Placebo needles consisting of a sliding tube and a retractible needle are applied to the acupunture reference point (marked by a pastille stuck on the skin). The patient should not be able to feel the difference between real acupuncture and sham acupuncture.
15835954|NCT04157179|Other|Carbon Dioxide|Participants inhale carbon dioxide while in magnetic resonance imaging scan to measure cerebrovascular reactivity
15835955|NCT04157166|Diagnostic Test|to record a whole body 3D of 25 minutes in camera VERITON-CT ™|The procedure of recording of 25 minutes in camera VERITON-CT ™ including the registration whole body 3D coupled to a scanner low dose (CT) will be added to conventional recording followed by complementary images SPECT/CT
15835956|NCT04157153|Device|Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold|Subjects with symptomatic coronary artery disease who qualify for percutaneous coronary intervention (PCI) will be treated with a sirolimus eluting resorbable coronary Magnesium scaffold
15835957|NCT04157140|Drug|Anlotinib|12mg, continuous oral 2 weeks stop for 1 week, 21 days for a treatment cycle.
15835958|NCT04157140|Device|TACE+RFA|TACE first, followed by RFA within day7（+/-3days）
15835959|NCT04157127|Biological|Autologous DC vaccine|Autologous DC vaccine given as 3 doses every 14 days. Dosage is cohort-dependent.
15835960|NCT04157114|Drug|MAP4343|Subjects will receive daily oral doses of MAP4343 for 6 weeks in conjunction with 6 weeks of manual-guided counseling
15835961|NCT04157114|Drug|Placebo|Subjects receive matched placebo for 6 weeks in conjunction with 6 weeks of manual-guided counseling
15835962|NCT04157114|Behavioral|Standardized behavioral counseling|Subjects receive manually-guided counseling 1 time per week for a 6 week duration
15835963|NCT04157101|Behavioral|Health Coaching|The 12-session remote health coaching intervention assists Veterans in developing and maintaining health behaviors that meet their life goals. Veterans begin by discussing their symptoms, the impact of their symptoms, and their beliefs about Pain-CMI. Next, the Veteran identifies discrepancies between where they are and where they want to be for 5 lifestyle factors. The first half of treatment focuses on providing education about the 5 lifestyle factors. Veterans are introduced to behavior change/health coaching principles. The major focus is on behavior change and development of long-term healthy habits. During the last session, Veterans develop a long-term plan to maintain behavioral changes after the 12-week program and identify the skills that they can utilize moving forward.
15835964|NCT04157101|Behavioral|Supportive Psychotherapy|"Our control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week (A time when I felt stressed was . ) in order to help identify experiences for discussion in session. The control consists of 12 weekly sessions delivered via telephone or video and will be delivered by bachelor's, or master's level providers."
15835967|NCT04157075|Drug|Bupivacaine|Bupivicaine injection into uterosacral ligaments prior to colpotomy
15835968|NCT04157062|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|During the rTMS session, an electromagnetic coil is placed against the subjects scalp. The electromagnet painlessly delivers a magnetic pulse that stimulates nerve cells in the region of the brain involved in memory and thinking.
15835969|NCT04157036|Drug|Ibuprofen|Subject will take 800mg Ibuprofen 45 minutes prior to anesthetic delivery
15835970|NCT04157036|Drug|Methylprednisolone|Subject will take 40mg Methylprednisolone 45 minutes prior to anesthetic delivery
15835971|NCT04157023|Device|Simulator-based Training of Direct Ophthalmoscopy|A digital simulator is used to teach the skills of direct ophthalmoscopy
15835972|NCT04157010|Drug|Tocilizumab|
15835973|NCT04157010|Drug|Methotrexate|
15835974|NCT04156997|Other|No intervention is involved in this study|No intervention is involved in this study
15835975|NCT04156984|Drug|Golimumab Prefilled Syringe|See arm description
15835976|NCT04156971|Dietary Supplement|Omega 3|
15835977|NCT04156971|Behavioral|stage-based lifestyle modification intervention|
15835978|NCT04156958|Drug|Fruquintinib|Fruquintinib will be administered orally at a dose of 5 mg/d, 3 weeks on, 1 week off (4 weeks as a cycle) until progression, unacceptable toxicity, or withdrawal unless toxicity not relieved after dose adjustment.
15836042|NCT04156529|Behavioral|ESRL position|Semi-elevated right lateral (ESRL) position was given during tube feeding
15836043|NCT04156516|Behavioral|HEART|sexual health intervention
15835979|NCT04156945|Behavioral|Behavioural intervention|An online tailored behavioural intervention. The intervention will be developed as part of the project and will be based on the principles of the Information-Motivation-Behavioural Skills (IBM) model for behavioural change. It will consist of four interactive text-based modules, and demonstration and modelling videos addressing information, motivation, and behavioural skills. The intervention will be offered on a website and able to be used on PCs as well as any mobile device. It will be provided to the participants after randomization at month 6 and available for a total period of 18 months.
15835980|NCT04156945|Diagnostic Test|HCV RNA home-based test|An additional patient-initiated home-based HCV testing service. The service offers a maximum of 4 free-of-charge HCV-RNA tests, which involves HCV testing using self-sampled dried blood spots (DBS). The DBS obtained from a finger stick will be used for HCV-RNA testing in the laboratory. DBS test kits, along with instructions and package materials for returning the test kits with the self-collected DBS sample will be provided to the participants after randomization at month 6 and available for use for a total period of 18 months.
15835981|NCT04156932|Procedure|uterine artery closure|Interruption the uterine blood flow by closing the uterine artery at its cervical-isthmic part or at its origin.
15835982|NCT04156919|Behavioral|fooya!™|fooya!™ is a science/evidence-based AI-enabled neuromodulation and Cognitive Behavior Therapy (CBT) technology. fooya!™ has been shown to deliver statistically significant outcomes concerning food choices during randomized-controlled clinical trials conducted at the Baylor College of Medicine's Children's Nutrition Research in the United States of America as well as India. In the game, children make several decisions with split-second timing, such as food choices, destroying bad/unhealthy food robots using the bad foods that are thrown at the player, and saving themselves. If the children collect good/healthy foods, they are in fit-zone for a while, which shields them from bad food robots.
15835983|NCT04156919|Other|WordSearch|We will have an active control group that will play a WordSearch game. The intention is to have the children play a familiar video game through the same modality (IPAD) that is unrelated to diet or lifestyle choices.
15835984|NCT04156906|Biological|D+ RH genotype matched red cell units for transfusion|Chronically transfused patients with SCD and anti-D will receive D+ RH genotyped matched red cell units for transfusion in addition to standard C, E, and K antigen matching and being hemoglobin S negative, which is the Children's Hospital of Philadelphia institutional standard of care for patients with SCD. RH genotyping of donor units will be performed by the New York Blood Center (NYBC) Immunogenetics laboratory.
15835985|NCT04156893|Biological|Red cell units that are genotype matched at the RHD and RHCE loci|Patients will be provided with red cell units that are C, E, and K antigen matched (standard of care for patients with SCD) and genotype matched at the RHD and RHCE loci.
15835986|NCT04156880|Other|mammography|standard mammography including craniocaudal (CC) and mediolateral oblique (MLO) views
15835987|NCT04156867|Device|Dynesys|discectomy with Dynesys
15835988|NCT04156854|Diagnostic Test|Quantitated Blood Volume Analysis|Measurement of total blood volume, composed of red blood cell mass (RBCM) and plasma volume (PV) by administering low dose iodinated I-131 labeled albumin intravenously then taking blood samples at timed increments.
15835989|NCT04156841|Diagnostic Test|mapping agent|according to different tracer methods, patients are divided into the implementation of a single mapping agent and implementation of combination of blue dye and radiotracer agent.
15835990|NCT04156841|Procedure|neoadjuvant chemotherapy|Patients were divided into two groups based on whether they were receiving neoadjuvant chemotherapy.
15835991|NCT04156828|Drug|Copanlisib|Given IV
15835992|NCT04156828|Drug|Gemcitabine|Given IV
15835993|NCT04156828|Drug|Carboplatin|Given IV
15835994|NCT04156828|Drug|Dexamethasone|Given PO
15835995|NCT04156828|Biological|Rituximab|Given IV
15835996|NCT04156828|Biological|Pegfilgrastim|Given SC
15835997|NCT04156815|Radiation|1,565nm NAFL|1,565nm M22-ResurFx NAFL can deliver additional benefits to existing acne scar and skin texture. Patients were first treated by the 1,565nm M22-ResurFx NAFL on inflammatory papules and boxcar atrophic scars using round or rectangle light spots with similar sizes of individual lesional papules or scars. The energy fluence was 60 mJ and spot density was 150 spots/cm2. A whole face pass treatment was followed using hexagon or rectangle light spots with fluences of 40-45 mJ, density of 200 spots/cm2 and no overlap on light spots. The end points of the treatment were appearance of localized erythema, edema and bruise on treated areas.
15835998|NCT04156815|Drug|Oral isotretinoin|Oral isotretinoin has remained the most effective medication for moderate-to-severe AV.Subjects received oral isotretinoin (Xingyi Yan'an Pharmaceutical, Shanghai, China) (1mg/kg/d for the first 2-4 weeks and 0.5mg/kg/d for the next 12-14 weeks) for a total of 16 weeks. Serum triglycerides, cholesterol and levels of liver enzymes were monitored every month during oral isotretinoin medication.
15835999|NCT04156815|Other|Pricking blood therapy|Pricking blood therapy (PBT) is a modified acupuncture strategy that is adapted to treat inflammatory related diseases. It has been shown to be effective in treatment of many chronic and acute inflammatory conditions including vasomotor rhinitis, acute herpes zoster and acute gouty arthritis,suggesting a potential efficacy for AV as well. At the end point of each session of laser treatment, an acupuncture practitioner performed a PBT in the areas within 1.5 cm radius of the five facial acupoints (Yintang, Zhukong, Sun, Yingxiang, Cuanzhu) (Figure 1). These areas usually appeared intensive erythema. A facial sheet mask was used to clean the face after PBT, and the face was cooled by air cooler for 10 minutes.
15836000|NCT04156802|Device|Real iTBS to the mPFC|This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key)
15836001|NCT04156802|Device|Sham iTBS to the mPFC|This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.
15836002|NCT04156802|Device|Real iTBS to the MC|This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key).
15836003|NCT04156802|Device|Sham iTBS to the MC|This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.
15836044|NCT04156516|Behavioral|HealthyMinds|Growth mindsets of personality and mental health
15836005|NCT04156776|Other|Muscle Energy Technique|Muscle energy technique was repeated 4 times per session every day for 3 days a week for 4 weeks after the application of moist heating pad for 30 minutes before each session.
15836006|NCT04156776|Other|Active Isolated Stretching|"The patient was asked to sit in an upright seated position and flex his/her knees 12 to 18 inches. Patient was asked to tuck the chin, exhale, and firmly contract the abdominal muscles as he/she curls their body forward. He/she was also guided not to bounce or make rapid movements at the end range of the active motion. Then, he was asked to move back to the starting position and repeat the same procedure for 8 to 10 times. Stretch on the end range was not more than 2 seconds.
~This technique was repeated 10 times per session every day for 3 days a week for 4 weeks after the application of moist heating pad for 30 minutes before each session."
15836007|NCT04156776|Other|Conventional Treatment|Conventional physical therapy treatment includes the application of moist heating pad for 30 minutes on lower back/ lumbar region prior to the intervention to both groups.
15836008|NCT04156750|Drug|LY3556050|Administered orally.
15836009|NCT04156750|Drug|Placebo|Administered orally.
15836010|NCT04156750|Drug|Iohexol|Administered IV.
15836011|NCT04156750|Drug|Metformin|Administered orally.
15836012|NCT04156737|Device|TECNIS Symfony plus IOL Model ZHR00V|IOL replaces the natural lens removed during cataract surgery
15836013|NCT04156737|Device|Trifocal Intraocular lens|IOL replaces the natural lens removed during cataract surgery
15836014|NCT04156724|Device|Helmet vetilation|We will apply non-invasive positive pressure ventilation via a helmet as interface
15836015|NCT04156711|Procedure|Remote Ischemic Preconditioning (RIPC)|Cycles of forearm ischemia and reperfusion by the inflation of a blood-pressure cuff over the systemic blood pressure for brief periods
15836016|NCT04156698|Drug|Docetaxel|Docetaxel is a chemotherapy drug.
15836017|NCT04156698|Drug|Cisplatin|Cisplatin is a chemotherapy drug.
15836018|NCT04156698|Drug|Capecitabine|Capecitabine is a chemotherapy drug.
15836019|NCT04156698|Drug|Camrelizumab|Camrelizumab is a humanized anti-PD1 IgG4 monoclonal antibody.
15836020|NCT04156698|Drug|Apatinib|Apatinib is a selective VEGFR2 inhibitor.
15836021|NCT04156685|Drug|Part A, Reference (D635 10/500mg, Astrazeneca)|Once a day. Under fasting condition
15836022|NCT04156685|Drug|Part A, Reference (D635 10/500mg, Astrazeneca)|Once a day. Under fasting condition
15836023|NCT04156685|Drug|Part B, Reference (D635 10/500mg, Astrazeneca)|Once a day. Under fed condition
15836024|NCT04156685|Drug|Part B, Reference (D635 10/500mg, Astrazeneca)|Once a day. Under fed condition
15836026|NCT04156646|Drug|Balovaptan|Balovaptan will be administered after a high-fat, high-calorie meal (Treatment A), after a 10-hour fast (Treatment B), and after a 10-hour fast with esomeprazole 40 mg (Treatment C)
15836027|NCT04156646|Drug|Esomeprazole|Esomeprazole will be administered once daily for 6 days and with a single dose of balovaptan 1 hour after the fifth esomeprazole dose
15836028|NCT04156633|Diagnostic Test|conventional identification method: biochemical profiling or MALDI-TOF MS|Identification of bacteria in positive blood cultures with MALDI-TOF MS from a subculture usually one day after the signal for a positive blood culture appears (from 2016 to 2018)
15836029|NCT04156633|Diagnostic Test|new identification method: Biofire FilmArray© BCID panel|The Biofire FilmArray© BCID Panel is performed directly from the positive blood culture without the need of subculture to reach single bacterial colonies (from 2018 and 2019)
15836030|NCT04156633|Diagnostic Test|new identification method: metagenomic WGS|shotgun metagenomic approach allows to sequence the whole genome (WGS) of pathogens and thereby potentially detect every potential pathogen and also resistance and virulence gene (from 2018 and 2019)
15836031|NCT04156620|Drug|Secukinumab|The subjects will receive secukinumab 6 mg/kg i.v. at randomization (Baseline (BSL) visit), followed by the administration of secukinumab 3 mg/kg i.v. every four weeks starting at Week 4 through Week 48 (exposure through Week 52)
15836032|NCT04156620|Drug|Placebo|The subjects will receive i.v. placebo at randomization (BSL visit), Weeks 4, 8, and 12 , followed by the administration of secukinumab 3 mg/kg i.v. at Week 16 and every four weeks through Week 48 (exposure through Week 52)
15836033|NCT04156607|Other|Kinesio taping|For the fascia technique, one part of the band which were divided by 4 fans is adhered on Achilles tendon to the heel with a 0% stretch. Then the plantar fascia was stretched by the examiner and the toes were extended (ankle dorsiflexion, toe extension) and the divided part of the band was applied toward the metatarsal heads with paper-off technique (5-15%).
15836034|NCT04156607|Other|Sham taping|''I'' bant were cut from the middle point of the Achilles tendon to the metatarsal heads. The band was applied from the Achilles tendon to the metatarsal heads without any stretching of plantar fascia and band.
15836035|NCT04156581|Drug|Bupivacaine|Bupivacaine is administered typically to reduce sensation in an area. It acts as a nerve block for surgical procedures.
15836036|NCT04156581|Drug|Dexamethasone|Dexamethasone is a corticosteroid that reduces inflammation.
15836037|NCT04156581|Other|Saline|Saline is a mixture of NaCl and water that can be used as a placebo.
15836038|NCT04156568|Drug|INH、RFT|6INH 10mg/kg 3INH+RFT 15mg/kg
15836039|NCT04156555|Drug|Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet|Oral amoxicillin-clavulanate 1 g twice a day for total of 6 doses
15836040|NCT04156542|Behavioral|Basic School Lunchroom Nudges|"The intervention consists of three components: 1) serving fresh fruit in attractive bowls in at least two locations on the lunch line; 2) providing descriptive names for the vegetables; and 3) increasing amount of plain milk availability by 10% and placing it in front of the chocolate milk. For the vegetable naming intervention, researchers first developed, printed, and laminated descriptive vegetable name cards (2x4). Some examples included Savory Collard Greens, and [School Mascot] Salad. Cafeteria staff affixed name cards to the serving line sneeze-guards in front of the vegetables for the day. For the fruit intervention, we purchased and delivered two ceramic bowls to the intervention school. The cafeteria staff filled the bowls and put them in different locations on the lunch line. For the milk intervention, cafeteria staff increased the amount of plain milk available by 10% and placed plain in front of chocolate milk in the coolers."
15836041|NCT04156529|Behavioral|ESU position|Semi-elevated supine (ESU) position was given during tube feeding
15836045|NCT04156503|Other|Palm olein vs Lard|A 5-hour postprandial feeding intervention with 2-weeks washout in between. Blood samples will be collected at hour 0 (baseline) before test meal, and hour 3, 4 and 5 after consumption of test meal.
15836046|NCT04156490|Other|No intervention is planned, this will be a purely retrospective trial.|Osmotic Therapy
15836047|NCT04156477|Dietary Supplement|Ketone ester|Intake of weight adjusted drink of a ketone ester
15836048|NCT04156477|Dietary Supplement|Glucose|Isocaloric and - volumetric taste adjusted drink
15836049|NCT04156477|Dietary Supplement|Tap water|Isovolumetric taste adjusted tap water (placebo)
15836050|NCT04156464|Drug|Phenobarbital|Phenobarbital loading dose followed by a taper will be given to control acute alcohol withdrawal syndrome
15836051|NCT04156464|Drug|Lorazepam|Ativan will be given according to our institutional alcohol withdrawal protocol to control acute alcohol withdrawal syndrome
15836052|NCT04156451|Procedure|Fluid resuscitation and furosemide administration (bolus and continuous) with central venous pressure target 8 - 10 mmHg|Crystalloid loading or furosemide administration with the CVP target 8-10 mmHg is reached in septic shock patients
15836053|NCT04156451|Procedure|Fluid deresuscitation and furosemide administration (bolus and continuous) with central venous pressure target 0 - 4 mmHg|active fluid removal with furosemide bolus and continuous or crystalloid loading until the CVP target 0-4 mmHg is reached in septic shock patients
15836054|NCT04156438|Device|Low tidal volume ventilation|Conventional ventilation strategy for patient with ARDS
15836055|NCT04156438|Device|Airway pressure release ventilation|Experimental ventilation protocol for patients with ARDS
15836056|NCT04156425|Drug|Escitalopram+golimumab|Escitalopram will be administered at 10-20 mg/d during the acute phase. Golimumab will be administered at the dose of 50mg every month during the acute phase.
15836057|NCT04156425|Dietary Supplement|Escitalopram+Calcium Tablet|Escitalopram will be administered at 10-20 mg/d during the acute phase. Calcium tablet will be administered at 2000mg/d during the acute phase.
15836058|NCT04156425|Drug|Escitalopram|Escitalopram will be administered at 10-20 mg/d during the acute phase.
15836059|NCT04156412|Device|Implant test procedure|Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy
15836060|NCT04156399|Other|Acupuncture|All subjects will receive a standardized 18 needle acupuncture protocol.
15836061|NCT04156386|Dietary Supplement|Recovery animal (20g whey) protein supplement|Animal protein supplement consumed post exercise to aid recovery of muscle function following strenuous exercise.
15836062|NCT04156386|Dietary Supplement|Recover vegan (26g pea) protein supplement|Vegan protein supplement consumed post exercise to aid recovery of muscle function following strenuous exercise.
15836063|NCT04156386|Dietary Supplement|Placebo (32g maltodextrin)|Placebo consumed post exercise to aid recovery of muscle function following strenuous exercise.
15836064|NCT04156373|Behavioral|Fuerte|Fuerte is a prevention program targeting youth at risk for psychological trauma who are recent immigrants to the United States. The program is evidence-informed using cognitive-behavioral principles and the Attachment, Regulation, and Competency (ARC) model for treating psychological trauma.
15836065|NCT04156347|Drug|Episcleral Topotecan|Transscleral Topotecan
15836066|NCT04156334|Procedure|Extraction of teeth in general anaesthesia using either computer-controlled intraosseous anesthesia device or carpule for local anaesthesia|QuickSleeper 5 with DHT needles or carpule with periapical/nerve block needles will be used to administer local anaesthetic before teeth extraction in general anaesthesia.
15836067|NCT04156321|Dietary Supplement|Moringa fry|"School Tiffin:
~Each of the adolescent girls will receive fresh Moringa leaves (150 gram) cooked in a traditional manner as Sajna shak (stir-fried)/ bora with rice and concentrated dal once daily for 5 days during tiffin time. Sajna Stir fry and bora will be given on every alternative day. Standard questionnaire will be used to measure the compliance of food. As we are serving the food in school premises during tiffin period, it would be both unethical and socially unacceptable if few of the students from a section receive the meal. Therefore, all the students from selected section/sections will receive the daily meal. However, we will only collect information from the selected study participants who would give consent to participate in the study Each of the combination of tiffin meal will supply 411 calories in the both arm ."
15836068|NCT04156308|Other|Osteopathic Manipulative Treatment (OMT) - Temp1|A total of 3 techniques selected from a list of 7 available techniques common to all centers will be applied in each session. The choice of techniques will be based on the results of the examination performed, the particularities of the patient and the clinical experience of the osteopath. In each session the techniques can change under the criteria of the osteopath. However, they will always be 3 and always within the list of available techniques.
15836069|NCT04156308|Other|Combined Exercises|A home-based pattern of combined exercises based on stretching, active anti-resisted exercises and joint mobility exercises focused on the cervico-dorsal and scapulo-thoracic regions. Whose clinical effectiveness has shown significant positive changes in pain levels and cervical functionality
15836070|NCT04156282|Procedure|knot burial technique|surgical suturing intervention
15836071|NCT04156282|Procedure|classical closure|surgical suturing intervention
15836072|NCT04156269|Biological|BCMA-CS1 cCAR T cells|BCMA-CS1 cCAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.
15836073|NCT04156256|Biological|CD123-CD33 cCAR T cells|CD123-CD33 cCAR T cells transduced with a lentiviral vector to express two distinct units of anti-CD123 and CD33 CARs.
15836074|NCT04156243|Biological|CD19 CARvac T cells|CD19 CARvac T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.
15836075|NCT04156230|Drug|[18F]GP1 positron emission tomography/computed tomography|A radioactive dose of 250 MBq of the study drug with a total quantity of ≤ 10 µg will be administered as slow intravenous bolus injection over up to 60 seconds. PET/CT examinations will be performed at 120 ± 15 min after the administration of [18F]GP1.
15836076|NCT04156217|Biological|EBV-TCR-T cells|EBV-TCR-T cells are prepared via lentiviral infection. patients with EBV emias or EBV positive PTLD will be enrolled, and donor derived EBV-TCR-T(HLA-A*1101\0201\2402) cells will be intravenously infused with a escalated dose of 0.1-1×106 EBV-TCR-T cells. The EBV DNA copies and EBV-TCR-T cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14, day 28).
15836077|NCT04156204|Other|Medication Event Monitoring System (MEMS)|AYA kidney recipients will receive a Medication Event Monitoring System (MEMS) via medication bottle and cap system
15836078|NCT04156204|Drug|Once-Daily Tacrolimus extended release|AYA kidney recipients will receive once daily tacrolimus XR 1-10mg daily
15836079|NCT04156191|Drug|ARQ-151 cream 0.15%|ARQ-151 cream 0.15% applied to atopic dermatitis lesions once a day for 28 days
15836080|NCT04156191|Drug|ARQ-151 cream 0.05%|ARQ-151 cream 0.05% applied to atopic dermatitis lesions once a day for 28 days
15836081|NCT04156178|Biological|CD20-CD19 cCAR T cells|CD20-CD19 cCAR T cells administered to patients, will be either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy
15836082|NCT04156165|Dietary Supplement|VLCD-Active|Lighter life formula products supplied to subjects, four sachets pr day. Dietetic advise given regularly.
15836083|NCT04156165|Other|Maintenance-Active|Weight loss maintenance diet with high protein and low glycemic index and load, high in fiber and whole grain, daily including 150 g minced beef.
15836084|NCT04156165|Dietary Supplement|VLCD-Control|Lighter life VLCD products
15836085|NCT04156165|Other|Maintenance-Control|Weight loss maintenance diet with moderate protein and low glycemic index and load, high in fiber and whole grain, daily including 25 g minced beef.
15836086|NCT04156152|Other|DEENSIBILIZING TOOTHPASTE BASED ON NANOCRISTALS OF HYDROXIAPATITA / 5% POTASSIC NITRATE / SODIUM MONOFluORPHOSPHATE 1450 PARTS PER MILLION|The toothpastes will be delivered by the researchers and will be applied with a manual toothbrush, with soft bristles and straight handle, by the patient.The 2nd, 3rd, 4th session (2nd, 4th, 6th week of follow-up) will be the application of tests and reinforcement of oral hygiene instruction. In the 5th session (8th week of follow-up) the pastes will be requested to verify compliance.
15836087|NCT04156152|Other|5% POTASSIC NITRATE / SODIUM FLUORIDE 1426 PARTS PER MILLION TOOTHPASTE|The toothpastes will be delivered by the researchers and will be applied with a manual toothbrush, with soft bristles and straight handle, by the patient.The 2nd, 3rd, 4th session (2nd, 4th, 6th week of follow-up) will be the application of tests and reinforcement of oral hygiene instruction. In the 5th session (8th week of follow-up) the pastes will be requested to verify compliance.
15836088|NCT04156139|Device|HFNC|The gas flow rate was set at 45~55 L/min. The inhaled oxygen concentration will be dynamically adjusted to maintain SpO2 ≥ 92%. The temperature will be set at 37 °C.
15836089|NCT04156139|Device|NPPV|The PEEP is initially set as 5 cm H2O, the inspiratory pressure is 10 cm H2O, and the target tidal volume is 6-8 ml/kg.
15836090|NCT04156126|Other|Blood Collection|Blood Collection
15836091|NCT04156113|Other|Yo-Yo intermittent recovery test (level 1)|The Yo-Yo intermittent recovery test (level 1) will be administered once.
15836092|NCT04156100|Drug|AGEN1223|AGEN1223 is a bispecific antibody.
15836093|NCT04156100|Drug|AGEN1223 and balstilimab|AGEN1223 is a bispecific antibody and balstilimab an anti-PD-1 Monoclonal Antibody.
15836094|NCT04156087|Drug|Durvalumab 50 MG/ML|"Combination of Durvalumab (fixed dose of 1500 mg) and Tremelimumab (fixed dose of 75 mg) will be given 2 weeks before surgery.
~Minimally invasive surgical microwave ablation (MIS-MWA) of the pancreatic tumor will be performed two weeks after the first dose of Durvalumab and Tremelimumab After 4 doses of Durvalumab and Tremelimumab, only Durvalumab 1500mg is provided q4w until disease progression.
~Systemic gemcitabine will be started 6 weeks after MIS-MWA. Gemcitabine will be given at a dose of 1000 mg /m² body surface, once a week for 3 weeks, followed with a week of rest."
15836095|NCT04156087|Drug|Tremelimumab|"Combination of Durvalumab (fixed dose of 1500 mg) and Tremelimumab (fixed dose of 75 mg) will be given 2 weeks before surgery.
~Minimally invasive surgical microwave ablation (MIS-MWA) of the pancreatic tumor will be performed two weeks after the first dose of Durvalumab and Tremelimumab After 4 doses of Durvalumab and Tremelimumab, only Durvalumab 1500mg is provided q4w until disease progression.
~Systemic gemcitabine will be started 6 weeks after MIS-MWA. Gemcitabine will be given at a dose of 1000 mg /m² body surface, once a week for 3 weeks, followed with a week of rest."
15836096|NCT04156087|Drug|Gemcitabine|"Combination of Durvalumab (fixed dose of 1500 mg) and Tremelimumab (fixed dose of 75 mg) will be given 2 weeks before surgery.
~Minimally invasive surgical microwave ablation (MIS-MWA) of the pancreatic tumor will be performed two weeks after the first dose of Durvalumab and Tremelimumab After 4 doses of Durvalumab and Tremelimumab, only Durvalumab 1500mg is provided q4w until disease progression.
~Systemic gemcitabine will be started 6 weeks after MIS-MWA. Gemcitabine will be given at a dose of 1000 mg /m² body surface, once a week for 3 weeks, followed with a week of rest."
15836097|NCT04156087|Procedure|Minimally Invasive Surgical Microwave Ablation (MIS-MWA)|Minimally invasive surgical microwave ablation (MIS-MWA) of the pancreatic tumor will be performed two weeks after the first dose of Durvalumab and Tremelimumab
15836098|NCT04156074|Dietary Supplement|Vitamin D enriched (20 mcg/day) olive oil emulsion drink|Vitamin D enriched (20 mcg/day) olive oil emulsion drink. 30 mL drink daily
15836099|NCT04156074|Dietary Supplement|Vitamin D enriched (20 mcg/day) coconut oil emulsion drink|Vitamin D enriched (20 mcg/day) coconut oil emulsion drink 30 mL drink daily
15836100|NCT04156074|Dietary Supplement|Placebo coconut oil emulsion drink|Placebo coconut oil emulsion drink 30 mL drink daily
15836101|NCT04156074|Dietary Supplement|Vitamin D supplement (20 mcg/day)|Vitamin D supplement (20 mcg/day) Pill consumed daily
15836102|NCT04156061|Other|Delivery of CT scan results|Method of results delivery - verbal or visual.
15836103|NCT04156035|Drug|Lamotrigine|Orally; 300 mg
15836104|NCT04156035|Drug|Ketamine|Intravenously; 0.12 mg/kg during the first minute followed by a continuous infusion of approximately 0.31 mg/kg/h over approx. 40 min
15836105|NCT04156035|Drug|Placebo Pretreatment|Lamotrigine Placebo
15836106|NCT04156035|Drug|Placebo Infusion|Ketamine Placebo
15836107|NCT04156022|Other|Dystonia Coalition is an observational study.|This is not an interventional study.
15836108|NCT04156009|Other|Activated Lavender Elequil aromatabs® (#372)|Activated Lavender aromatherapy tablets wrapped in tape
15836109|NCT04156009|Other|Unactivated Lavender Elequil aromatabs® (#372)|Unactivated Lavender aromatherapy tablets wrapped in tape
15836110|NCT04155996|Device|data collection|Patients will receive a full data acquisition set with CGM sensors, an activity tracker and a smartphone application in which they can log daily events.
15836111|NCT04155983|Drug|Ropivacaine|The drug will be administered in the same dosage in both arms. The location of the injection will vary by arm.
15836112|NCT04155970|Other|Manual therapy|Manual therapy, which includes spinal manipulation; spinal mobilisation; light massage; and trigger point therapy.
15836113|NCT04155970|Other|Evidence-informed home management booklet|The home management booklet includes advice on posture, over the counter pain medication, cold and heat packs. The booklet also includes a section on patient reassurance and where to seek help from a medical professional in an emergency.
15836114|NCT04155957|Other|Rapid Recovery Rehabilitation Programme|"Usual intervention at Hospital Clínic de Barcelona for post-operative rehabilitation of TKA patients. Participants, already at home after hospital discharge, must perform 5 different exercises 4 times a day (twice in the morning, twice in the afternoon).
~Participants are also encouraged to walk and stretch their legs. Domiciliary visits by a physiotherapist start at approximately 2 weeks after the surgery to help participants do the exercises."
15836115|NCT04155957|Device|ReHub|"Participants use a telerehabilitation platform, ReHub, as a guide to perform the TKA rehabilitation exercises of the Rapid Recovery Rehabilitation Programme intervention.
~The exercise plan in ReHub is carried out by a site physiotherapist on the first day after discharge by using ReHub to acquire the participant's movement pattern with a wearable inertial sensor that transmits data to the platform.
~The wearable inertial sensor participants must wear tracks movement while they do the TKA rehabilitation exercises. Movement is analysed and feedback is given in real time. At the end of each exercise, participants can select if they have felt pain in a scale from 1 to 10. A physiotherapist monitors the participants' progress remotely."
15836116|NCT04155931|Other|body temperature measurement|Postoperative analgesic and antiemetic requirements, nausea and vomiting were observed in the recovery room at 6, 12 and 24 hours
15836117|NCT04155918|Drug|Group 1: AR882 Alone and in Combination with Febuxostat (FBX)|AR882 + Febuxostat, AR882 alone, Febuxostat alone
15836118|NCT04155918|Drug|Group 2: AR882 Alone and in Combination with Allopurinol (ALLO)|AR882 + Allopurinol, AR882 alone, Allopurinol alone
15836119|NCT04155905|Procedure|fistulotomy and marsupialization of wound edges|after defining the fistulous track it was laid open (marsupialization) was done together with marsupialization of the wound edge with vicryl 3\0 sutures
15836120|NCT04155905|Procedure|fistulotomy|after defining the fistulous track it was laid open (marsupialization)
15836121|NCT04155879|Drug|Colchicine Tablets|Administration of Colchicine at a dose of 0.5mg 2x a day for six months.
15836122|NCT04155879|Procedure|Cardioversion|Electrical or pharmacologic restoration of sinus rhythm
15836123|NCT04155866|Other|Measurement of muscle activation.|Measurement of lower-limb muscle activation during walking for healthy participants.
15836124|NCT04155853|Procedure|Interposition Arthroplasty|A typical Wagner incision will be used at the thenar skin one centimeter distal to the radial styloid. The interval between the abductor pollicis longus and the extensor pollicis brevis will be developed, while protecting the dorsal sensory branches of the radial nerve. A longitudinal capsulotomy will be performed and after identifying the carpometacarpal and scaphotrapeziotrapezoid joints, the trapezium will be excised. Then, the empty space will be filled with a roll of fascia lata and fixed with a K-wire. The 1.4 millimeter K-wire will be introduced two centimeters distally to the metacarpal base and into the body of the trapezium. In case of scaphotrapeziotrapezoid joint arthritis, debridement and osteophyte excision of the scaphotrapezoid joint will be performed. In the end of the procedure, the capsule and the skin will be sutured, and a thumb spica will be placed to all patients.
15836125|NCT04155853|Procedure|Hematoma and Distraction Arthroplasty|A typical Wagner incision will be used at the thenar skin one centimeter distal to the radial styloid. The interval between the abductor pollicis longus and the extensor pollicis brevis will be developed, while protecting the dorsal sensory branches of the radial nerve. A longitudinal capsulotomy will be performed and after identifying the carpometacarpal and scaphotrapeziotrapezoid joints, the trapezium will be excised. Then, the empty space will be stabilized with a K-wire without interposition of any material. The 1.4 millimeter K-wire will be introduced two centimeters distally to the metacarpal base and into the body of the trapezium. In case of scaphotrapeziotrapezoid joint arthritis, debridement and osteophyte excision of the scaphotrapezoid joint will be performed. In the end of the procedure, the capsule and the skin will be sutured, and a thumb spica will be placed to all patients.
15836126|NCT04155840|Drug|Copanlisib|Given IV
15836127|NCT04155840|Biological|Rituximab|Given IV
15836128|NCT04155840|Drug|Bendamustine|Given IV
15836129|NCT04155827|Other|SIT|Sprint interval training of 4*4, with 30 seconds of all out workout followed by 4 minutes of active recovery for 4 cycles.
15836130|NCT04155814|Drug|Iron Sucrose Injection|USP 100 mg/5 mL (20 mg/mL), solution for IV injection, 100 mg unit dose strength
15836131|NCT04155814|Drug|Venofer Injection|(Iron Sucrose 20 mg/mL), solution for IV injection, 100 mg unit dose strength
15836132|NCT04155801|Dietary Supplement|Salix Probiotic Blend|Oral capsule. The probiotic strains comprise the Salix Probiotic Blend include 3 strains of Bifidobacterium lactis (Bl-04®, Bi-07®, HN019) and 2 strains of lactobacillus (Lactobacillus acidophilus [NCFM]® and Lactobacillus paracasei [Lpc-37]®).
15836133|NCT04155788|Behavioral|Food Exposure|Participants will complete a meal exposure using one of their feared foods.
15836134|NCT04155775|Other|Computer electronic health record alert (Best Practice Alert - BPA)|Upon ordering platelets in patients with recent platelet count >50,000, a pop-up within the electronic health system will recommend to not continue with transfuse product order and provide clinical exceptions to continue. Importantly, the alert does not trigger in operating areas, emergency medicine treatment areas, for certain specialties like neurosurgery or for massive transfusion orders.
15836135|NCT04155762|Other|Pin Suspension System (a prosthetic suspension system)|Participants used the PSS for three months following fabrication and adjustment of the prosthesis, and a prosthetic training period.
15836136|NCT04155762|Other|Vacuum-Assisted Suspension System (a prosthetic suspension system)|After PSS, participants employed the VASS for three months after a similar training period.
15836137|NCT04155749|Drug|CART-ddBCMA|Chimeric Antigen Receptor T cells
15836175|NCT04155450|Other|Moist Heat|Moist Heating for 10 minutes at lumbar spine in prone position using moist heat packs, heated via hydro-collator.
15836198|NCT04155242|Diagnostic Test|Assessment of the panel of molecular biomarkers: IM-SCORE, TFF3 protein expression, methylation panel, p53 mutation|Molecular analysis of the specimen obtained by Cytosponge or endoscopic biopsies - TFF3 protein expression, methylation panel, p53 mutation. Endoscopic biopsies will be assessed for the presence of IM (according to the IM-score).
15836138|NCT04155736|Behavioral|Renew|Renew is a behavioral health self-management app/too that focuses on three core activities: 1) in vivo exposure (to help participants approach safe situations they have been avoiding that they want to feel comfortable in), 2) expressive writing (to help participants emotionally process trauma memories), and 3) Self-Care exercises (designed to promote behavioral activation, social connectedness and relaxation; includes a breathing relaxation tool). Users have access to psychoeducation via a whiteboard video and short texts as well as Motivation content (quotes, videos, images, and songs) related to confronting challenges and overcoming fears. For each exercise that is completed, the user earns points that are connected to levels and visually reinforcing images (i.e., a growing tree).
15836139|NCT04155710|Biological|IOV-2001|Adoptive cell therapy (ACT) manufactured from peripheral blood lymphocytes (PBL). The final investigational product is a cryopreserved cell suspension.
15836140|NCT04155710|Drug|Low dose IL-2|6 doses of subcutaneous (SC) LD-IL-2 (9 MIU every 8-12 hours) will follow the infusion of IOV-2001
15836141|NCT04155710|Drug|High dose IL-2|6 doses of IV HD-IL-2 (600,000 IU/kg Q8-12H will follow the infusion of IOV-2001
15836142|NCT04155710|Drug|IL-2|6 doses of IL-2 will follow the infusion of IOV-2001
15836143|NCT04155697|Drug|2% Chlorohexidine Gluconate soap|Participants will wash hands for 30 seconds with 2% Chlorohexidine Gluconate soap.
15836144|NCT04155697|Drug|62% ethyl alcohol-based hand sanitizer|Participants will apply 62% ethyl alcohol-based hand sanitizer for 30 seconds
15836145|NCT04155671|Drug|POF|Paclitaxel plus Oxaliplatin plus Leucovorin plus 5-FU
15836146|NCT04155671|Drug|FOLFOX plus PAC(ip)|FOLFOX plus intraperitoneally paclitaxel
15836147|NCT04155658|Other|Experimental Toothpaste containing 1450ppm SMFP|Experimental Toothpaste containing 1450ppm SMFP
15836148|NCT04155658|Other|Toothpaste containing 1450ppm SMFP|Toothpaste containing 1450ppm SMFP
15836149|NCT04155658|Other|Toothpaste with no fluoride|Toothpaste with no fluoride
15836150|NCT04155645|Drug|AZD8233 subcutaneous injection|Randomized subjects will receive SC dose of AZD8233 (dose 1, dose 2, and dose 3) injection.
15836151|NCT04155645|Drug|Placebo|Randomized subjects will receive SC dose of placebo injection.
15836152|NCT04155632|Drug|N-acetylcysteine|N-acetylcysteine (NAC) is a medication that is used to treat paracetamol (acetaminophen) overdose, and to loosen thick mucus in individuals with cystic fibrosis or chronic obstructive pulmonary disease. It has a long-established safety record in adults and children, with FDA approval since 1963. The side effects most commonly noted in people who take NAC by mouth include diarrhea, nausea, vomiting, and headache. These side effects are usually mild and go away even with continued use of NAC by mouth. There is also a risk of a skin reaction, such as flushing, itching, or rash. A meta-analysis of studies evaluating long-term oral treatment with NAC for prevention of chronic bronchitis found that NAC was well tolerated, with generally mild, most commonly gastrointestinal adverse effects that did not require treatment interruption.
15836153|NCT04155632|Device|Theta-burst stimulation (TBS)|Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected.
15836154|NCT04155619|Behavioral|No change in meal timing|Participants will eat within an ≥11-hour daily period (no change in meal timing habits).
15836155|NCT04155619|Behavioral|No change in light exposure|Participants will not change their light exposure habits.
15836156|NCT04155619|Behavioral|Early Time-Restricted Feeding|Participants will eat within an 8-hour daily period early in the day, starting within 2 hours of waking up.
15836157|NCT04155619|Behavioral|Timed Light Therapy|Participants will use bright light therapy for 60 minutes between 6 am - 3 pm, blue light-blocking glasses for one hour before bedtime, and blackout curtains at night.
15836158|NCT04155606|Device|microsurgery; endovascular interventions|microsurgery: surgical resection of the aneurysm endovascular interventions: coiling, stenting or both
15836159|NCT04155580|Drug|ASTX660|Capsule for oral administration
15836160|NCT04155580|Drug|ASTX727|Tablet for oral administration
15836161|NCT04155567|Drug|TAK-123|TAK-123 infusion
15836162|NCT04155554|Drug|Bictegravir/emtricitabine/tenofovir alafenamide|Switch patients from dolutegravir/lamivudine/abacavir to bictegravir/emtricitabine/tenefovir alafenamide to study neuropsychiatric side effects and neurocognitive function
15836163|NCT04155554|Drug|Dolutegravir/lamivudine/abacavir|Continuing dolutegravir/lamivudine/abacavir to study neuropsychiatric side effects and neurocognitive function
15836164|NCT04155541|Drug|dacomitinib hydrate|The usual adult starting dosage for oral use is 45mg of dacomitinib hydrate once daily. The dose should be reduced appropriately according to the patient's condition.
15836165|NCT04155528|Other|Music therapy|The intervention is listening to selected prerecorded music, specific Raga, on the individual CD player.
15836166|NCT04155515|Drug|TG-2349|TG-2349 400mg
15836167|NCT04155515|Drug|DAG181|DAG181 200mg
15836168|NCT04155515|Drug|Ribavirin|Ribavirin 1000mg/1200mg
15836169|NCT04155489|Procedure|blood transfusion|In the restrictive blood transfusion group, if the hemoglobin value is less than 8 g /dL or if there are suspected symptoms of anemia such as dizziness or chest pain, headache, low on energy, blood transfusion is started. in the liberal transfusion group, If the hemoglobin value is less than 10 g /dL, blood transfusions begin.
15836170|NCT04155476|Drug|Nitroglycerin Topical Product|application of NG topical to dorsals pedis and posterior tibial arteries.
15836171|NCT04155463|Other|Organic Diet|Participants will receive 7 days-worth of organic food. Organic food is certified through the USDA's National Organic Program as produced without the use of synthetic pesticides, including glyphosate.
15836172|NCT04155463|Other|Conventional Diet|Participants will receive 7 days-worth of conventionally grown (non-organic) food.
15836173|NCT04155450|Other|Extension Biased External Limb Loading Exercises|"Begin in the quadruped position and progress the intensity by
~Flexing one upper extremity
~Extending one lower extremity with a leg slide
~Extending one lower extremity by lifting it off the mat
~Flexing one upper extremity while extending contralateral lower extremity and then alternate to opposite extremities.
~Progress to prone position:
~Extending one lower extremity
~Extending both lower extremity"
15836174|NCT04155450|Other|McKenzie Extension Exercise Protocol|"Static:
~Lying Prone
~Lying prone in extension
~Sustained extension
~Posture correction
~Dynamic:
~Extension in lying
~Extension in lying with clinician overpressure
~Extension mobilization
~Extension in standing"
15836176|NCT04155437|Behavioral|Health Facility Level Interventions|"Intensified counseling on maternal dietary diversity and quality using job aids
~Counseling on purpose of IFA supplementation, managing side effects, and importance of adherence to daily consumption
~Distribution/prescription of IFA tablets at each ANC visit
~Use of pill card/reminders for pregnant women and their spouses
~Monthly IFA tablet stock monitoring to assure sufficient supplies
~Measurement of weight gain during each ANC visit and advise on healthy weight gain
~Checks for functioning scales and use of monitoring sheets
~Intensified counseling on early initiation of breastfeeding and exclusive breastfeeding using job aids
~Reminder on importance of early ANC attendance and 4+ visits"
15836177|NCT04155437|Behavioral|Community Level Interventions|"Advocacy among community leaders (traditional and religious leaders, local associations, etc.) about ANC
~Gatherings among grandmothers, husbands, and other influencers about ANC and their roles
~Promotion of ANC service utilisation and the importance of early ANC visit during the first trimester.
~Early identification of pregnant women
~Support women's group discussions
~2-3 home visits per pregnant woman by community health workers (Agent de santé a base communautaire; ASBC) which will include counseling on diet quality, breastfeeding, importance on adherence to daily IFA consumption and side effect management, etc."
15836178|NCT04155437|Behavioral|Health System Level Interventions|"Training on nutrition interventions during ANC for all ANC providers and community health workers
~Semi-annual supervision by the Regional Health Directorate (Direction Regionale de la Santé; DRS)
~Quarterly supportive supervision of health facility staff by the health district management team
~Monthly supportive supervision of ASBCs
~Monthly review between health facilities and ASBCs
~Training and use of data registers
~Training and use of mother's cards to record up to 8 ANC visits and nutrition services
~Training on data utilization to improve coverage and quality"
15836179|NCT04155424|Drug|Eculizumab|Following a weight-based weekly dose of eculizumab during an induction phase, participants will receive weight-based doses of eculizumab every 2 weeks during the Primary Treatment Period and Extension Treatment Period.
15836180|NCT04155411|Drug|Dasatinib|70 mg of Dasatinib orally daily for 12 months
15836181|NCT04155398|Procedure|EUS elastography|A forward view radial echoendoscope or a forward oblique view linear echoendoscope would be used to perform focused luminal examination of varices and EUS elastography for measurement of liver stiffness and spleen stiffness.
15836182|NCT04155385|Other|Measurement|The measurement system collects information about patients' treatment progress and goals in key areas that are associated with long-term clinical outcomes (e.g., substance use, craving, coping skills, self-efficacy, life satisfaction, depression). Patients complete the measure up to once per week for up to six months.
15836183|NCT04155385|Other|Feedback|The feedback system is a web-based dashboard that displays current and historical results in each of the outcome and goal domains that is measured; it is available to addiction treatment clinicians who are working with patients enrolled in the study.
15836184|NCT04155372|Procedure|Different Fluid Ingestion Rate|The participants ingested sports drink in a volume equivalent to 150% of BW loss, in 30 min, 60 min, or 90min.
15836185|NCT04155346|Behavioral|Exercise, nutritional optimization, and psychoeducation|Multimodal prehabilitation including exercise, nutrition, and stress-management delivered via a facility-based or home-based model
15836186|NCT04155333|Device|Transcranial direct current stimulation|Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation that stimulates the brain through the application of a low-intensity electrical current, typically ranging from 1 to 2 milliamps (mA), via electrodes placed on an individual's scalp. During the active stimulation sessions, 2 mA of stimulation will be applied for 30 minutes. During the sham stimulation session, 2 mA of stimulation will be applied over the course of 90 sec, the electrodes will remain in place for the 30 minute duration.
15836187|NCT04155320|Behavioral|IMPART|Subjects receive counseling about partner notification and are assisted in identifying all their partners and choosing a notification method for each partner. Subjects have the option to: 1) disclose their HIV status to their partner(s) by themselves (self-tell), 2) disclose their HIV status to their partner(s) with a healthcare provider present (tell together), or 3) have their partner(s) notified confidentially by a disease notifier (anonymous provider referral), who will locate partners, notify them of potential HIV exposure, and offer them HIV testing. Partners with an initial reactive HIV screening test will be referred to care and treatment services.
15836188|NCT04155320|Behavioral|Standard Care|Subjects receive counseling about partner notification and are assisted in identifying all their partners and choosing a notification method for each partner. Subjects are responsible for contacting and notifying their partner(s) on their own. Subjects have the option to: 1) disclose their HIV status to their partner(s) by themselves (self-tell) or 2) disclose their HIV status to their partner(s) with a healthcare provider present (tell together). Subjects may decide which partners to notify and may choose the same or a different method for each partner.
15836189|NCT04155307|Device|Anal EndoFLIP®|Anal EndoFLIP® measure to evaluate anal compliance
15836190|NCT04155307|Diagnostic Test|Anal Manometry|Anal Manometry done in standard care
15836191|NCT04155307|Diagnostic Test|Defecography|Defecographydone in standard care
15836192|NCT04155307|Diagnostic Test|Electromyogram|Electromyogram done in standard care
15836193|NCT04155281|Other|urine analysis|New Psychoactive Substances research in urine at admission in unit care
15836194|NCT04155268|Behavioral|Flotation-REST|Floating in a specialized device (float pod or float cabin) used to attenuate sensory input.
15836195|NCT04155268|Behavioral|Dark Room|Participants will lay on an air mattress in a dark room with no cell phone and reduced sensory input.
15836196|NCT04155255|Other|MyBFF@school|
15836197|NCT04155242|Diagnostic Test|Cytosponge test|The Cytosponge will be administered by the study nurse prior to the participant having the endoscopy, usually as part of the same visit to hospital. The capsule along with the string is swallowed by drinking a small glass of water. The participant is asked to hold the Cytosponge in situ for 5 minutes. The sponge contained within expands and is then drawn back by the research nurse up the oesophagus by the attached string, collecting cells as it moves upwards. This device received a letter of no objection by the MHRA for use in the BEST pilot trial (LRQ 0939857) but it is not CE marked. Cytosponge and research endoscopic biopsies will be couriered to the Fitzgerald laboratory, at the MRC Cancer Cell Unit on a regular basis. The specimens will be processed in conjunction with the Cambridge University Hospitals' NHS Foundation Trust tissue bank which is accredited to GLP standards.
15836274|NCT04154722|Drug|Meropenem Injection|inj meropenum for 10 days
15836199|NCT04155242|Diagnostic Test|Oesophagogastroduodenoscopy|"Endoscopy will be carried out with white light and NBI with optical magnification or near focus to inspect oesophagus and GOJ.
~NBI magnification will be used to assess systematically the mucosal pit pattern at the GOJ and to look for light blue crest (LBC) sign.
~Targeted biopsies will be taken from either areas with LBC or irregular pit pattern on NBI, followed by random biopsies as per clinical standard. A maximum of 6 biopsies will be taken at the GOJ (maximum 4 targeted and 4 random.. During the first 2 post RFA follow up, at discretion of the endoscopists, neo-suqamous biopsies can be taken in line with local policies.
~Argon plasma coagulation ablation is allowed in a single island up to 5mm or up to 3 islands <3mm within the study endoscopy as long as this does not represent an obstacle to GOJ biopsies."
15836200|NCT04155229|Other|Default settings for opioid prescriptions (acetaminophen/hydrocodone, oxycodone, acetaminophen/oxycodone)|"For each of the arms, the investigators modified the default setting for the dispense quantity of study opioids on the electronic medical record settings for discharge prescriptions.
~Study drugs include acetaminophen 325mg + hydrocodone 5mg, acetaminophen 325mg + hydrocodone 7.5mg, acetaminophen 325mg + hydrocodone 10mg, oxycodone 5mg, acetaminophen 325mg + oxycodone 5mg, acetaminophen 325mg + oxycodone 10mg."
15836201|NCT04155216|Behavioral|Relaxation and guided imagery program|Listening to a relaxation and guided imagery program for 25 minutes during hemodialysis treatments.
15836202|NCT04155203|Drug|Mupirocin Calcium|mupirocin cream
15836203|NCT04155203|Drug|Mupirocin Calcium|Reference mupirocin cream
15836204|NCT04155203|Drug|Vehicle|vehicle control cream
15836205|NCT04155190|Drug|Patidegib Topical Gel, 2%|Patidegib Topical Gel, 2%
15836206|NCT04155190|Drug|Patidegib Topical Gel, Vehicle|Patidegib Topical Gel, Vehicle
15836207|NCT04155177|Procedure|training for french ambulatory caesarean section|"The participant will be first invited to consult a theoretical support and a video treating on FAUCS.
~After that, he will be asked to be the first assistant, in a FAUCS procedure with one of the two senior surgeons assigned for the study.
~In a second step, the trainee will have to perform all the steps of the FAUCS, assisted by one of the two senior surgeons . During each surgery, Operative time will be measured, while an evaluation on four stages according to the Zwisch model of supervision will performed by the senior surgeons .
~Once, the two seniors agree on the highest level assessment for the resident, he will be allowed to operate alone FAUCS procedures and will be evaluated by the measurement of operating times, the neonatal outcomes and the occurrence or not of complications.
~finally, total number of FAUCS procedures required for each resident in order to master the technique will be determined."
15836208|NCT04155164|Drug|Metformin|Participants will receive Metformin at 1000mg for 12 months.
15836209|NCT04155164|Drug|Placebos|Placebo group will take Placebo at 1000mg for 12 months.
15836210|NCT04155151|Other|6 minute walk test|A test of fitness that requests the participant to walk as far as they can at their own pace in 6 minutes, the distance walked in those 6 minutes is recorded.
15836211|NCT04155138|Device|Naida Hearing Aid|hearing aid
15836212|NCT04155138|Device|Naida Contralateral Routing of Sound Device|This is a device that routes sound to the non-cochlear implanted ear.
15836213|NCT04155125|Drug|efepoetin alfa|The administration interval and initial dosage for subjects who are randomly assigned to subcutaneous efepoetin alfa will be starting from 4 μg/kg BW once per 2 weeks, then titrated based on Hb level during study period.
15836214|NCT04155125|Drug|Mircera|The starting dosage of Mircera arm will be 0.6 μg/kg BW per 2 weeks based on prior data in similar study populations with subsequent titration to achieve targeted Hb range. During the correction treatment period, the dosage of study drug will be adjusted to achieve a Hb level range within 10 - 12 g/dL and an increase ≥1.0 g/dL versus the individual patient's baseline Hb level. During the extension period, Hb levels should be maintained between 10 and 12 g/dL.
15836215|NCT04155112|Other|Exercise|energy deficit by increased physical activity
15836216|NCT04155112|Other|Mediterranean diet|energy deficit by dieting
15836217|NCT04155099|Biological|RBX7455|RBX7455 is a preparation of live intestinal microorganisms (active drug) purified from stool donations obtained from healthy, screened donors, mixed with preservative, lyophilized, and put into capsules. The capsules are taken orally (i.e., by mouth). After ingestion, these freeze-dried microorganisms can reconstitute and proliferate in the gut.
15836218|NCT04155099|Biological|Placebo|Capsule with cellulose filler
15836219|NCT04155086|Biological|the detection of the risk of fetal trisomy 21 by blood tests : free fetal DNA circulant analysis|The detection of the risk of fetal trisomy 21 by blood tests by 2 tests : free fetal DNA circulant analysis and first trimester serum screening
15836220|NCT04155073|Behavioral|smoking cessation, early COPD detection, electronic visit|electronic visits (e-visits) for smoking cessation and early detection of chronic obstructive pulmonary disease (COPD)
15836221|NCT04155073|Other|Treatment As Usual|Information about the state quitline and about the importance of quitting smoking and a recommendation to contact one's PCP to schedule a medical visit to discuss quitting smoking
15836222|NCT04155047|Combination Product|Glyocopyrrolate Inhalation Solution administered by Magnair|glycopyrrolate Inhalation Solution 25mcg, single dose
15836223|NCT04155047|Drug|Placebo administered by Magnair|Placebo Inhalation Solution
15836224|NCT04155034|Procedure|Magnetic Resonance Imaging|Undergo MRI
15836225|NCT04155034|Radiation|Prophylactic Cranial Irradiation|Undergo PCI
15836226|NCT04155008|Drug|Dexamethasone|If the patient's prognosis is extremely poor (less than 12 weeks expected survival, based on discussion with the patient's treating physicians) and there is no additional disease modifying therapy planned, the patient will be prescribed 4mg dexamethasone (which is FDA approved), once daily, to be taken orally in the morning.
15836227|NCT04155008|Drug|Dronabinol|If the patient has a history of marijuana use or has tried it in the past and had a positive experience with it, then the patient will be prescribed dronabinol (which is FDA approved) 2.5mg, twice daily before meals.
15836228|NCT04155008|Drug|Mirtazapine|If the patient does not have any history of marijuana use, mirtazapine will be prescribed. If the patient is under the age of 70, then the patient would be prescribed 15mg of mirtazapine (which is FDA approved), once daily, to be taken orally at bedtime. For geriatric population (if the patient is over the age of 70), then the patient would be prescribed 7.5mg of mirtazapine, once daily to be taken orally at bedtime.
15836275|NCT04154722|Drug|Azithromycin Powder|syp azithromycin for10days
15836229|NCT04155008|Behavioral|Nutrition Intervention|"Nutrition intervention will be in accordance with the Academy of Nutrition and Dietetics guidelines. The intervention will involve purposefully planned action(s) designed with the intent of changing a nutrition-related behavior, risk factor, environmental condition, or aspect of health status"
15836230|NCT04154995|Diagnostic Test|Venipuncture|Blood testing at 3, 6 and 12 months
15836231|NCT04154995|Diagnostic Test|Ultrasound Quadriceps Muscles|Ultrasound measurement of quadriceps muscle mass and health
15836232|NCT04154982|Drug|Acetyl cysteine|1200 mg of NAC are intravenously administrated 1 hour prior to carrying out CAP.
15836233|NCT04154969|Other|Physiotherapy including Vestibular rehabilitation|vestibular exercise (VOR TX1)
15836234|NCT04154969|Other|conventional Physiotherapy|conventional Physiotherapy
15836235|NCT04154956|Drug|tusamitamab ravtansine|Pharmaceutical form: Concentrate for solution for intravenous infusion Route of administration: intravenous (IV) infusion
15836236|NCT04154956|Drug|Docetaxel|Pharmaceutical form: Concentrate for solution for intravenous infusion Route of administration: IV infusion
15836237|NCT04154943|Drug|Cemiplimab|Intravenous (IV) infusion every 3 weeks (Q3W)
15836238|NCT04154930|Device|Restylane-L®|Intradermal injection
15836239|NCT04154917|Other|HOME|HOME's focus is on the person's functional ability, safety and transition from hospital to home. HOME will be delivered by a community-based clinician (OT who will be involved in the hospital discharge planning) trained by the PI. Training will include two sessions covering assessment of functional ability, goal setting and home safety. The clinician will keep a record of recommendations provided, length of home visit and any adverse events during the intervention. Twice over the course of the study, the PI leader will observe the clinician conducting HOME interventions to assess adherence to the study protocol using a fidelity checklist. The HOME intervention comprises 4 phases, which are described in the arms section.
15836240|NCT04154904|Other|Exercise|Subjects will be randomized to complete either aerobic, high intensity interval training, or resistance exercise videos twice weekly at home.
15836241|NCT04154891|Genetic|Trio Whole Genome Sequencing|WGS trio analysis will be performed using the genome data of the index case in addition to the genome data of his parents. This analysis will follow a consensus protocol that contains 3 obligatory steps: first of all, de novo variants (SNV, CNV and others SV) will be examined in the whole genome data set; then, a SNV/CNV/other SV analysis will be performed under a AR or X linked Mendelian mode hypothesis in the whole genomic regions of a OMIM extended list (that contains all genes already involved in human genetic diseases). Finally, analysis will focus on inherited pathogenic variants under an AD mode hypothesis (analysis of variations already reported as pathogenic in clinVar or HGMD pro; CNV or truncating variation in OMIM genes, etc). When these 3 steps analysis is completed then variants of interest identified at each step will be recorded until examination by a specific multidisciplinary meeting.
15836242|NCT04154891|Genetic|Simplex Whole Genome Sequencing|This analysis will be performed using only the index case following a similar strategy than the one used for the WGS trio
15836243|NCT04154891|Genetic|Current French Reference strategy|Actual ANPGM recommendations defined by the following analysis: Fra-X + chromosomal microarray analysis + 44GPS
15836244|NCT04154865|Other|Hypercapnia|Eligible subjects will undergo transcranial Doppler assessment before and after hypercapnia exposure.
15836245|NCT04154865|Device|Transcranial Doppler|A transcranial Doppler ultrasound probe will be used to assess middle cerebral artery velocity to quantify cerebral blood flow at various time points throughout the study visit.
15836246|NCT04154865|Device|Cycle ergometer|A cycle ergometer will be used to acutely increase cerebral blood flow.
15836247|NCT04154865|Other|Cognitive Tests|A battery of cognitive tests will be completed by the subject.
15836248|NCT04154852|Drug|Adalimumab|
15836249|NCT04154852|Drug|Methotrexate|
15836250|NCT04154852|Drug|Placebo|Placebo to replace adalimumab
15836251|NCT04154852|Drug|Folic Acid|
15836252|NCT04154826|Drug|Recombinant human interleukin-7|weekly intra-muscular (IM) administration
15836253|NCT04154813|Drug|Topiramate|The initial dose of 25mg/d is rapidly increased to the target dose (100mg/d) or below the maximum tolerable dose if the patient can tolerate it.
15836254|NCT04154813|Drug|Fluoxetine|Fluoxetine was increased from 20mg/d to the target dose (60mg/d) or below the maximum tolerable dose within 2 weeks.
15836255|NCT04154813|Behavioral|cognitive behavioral therapy (CBT)|CBT psychotherapy, once a week for three months.
15836256|NCT04154813|Behavioral|dialectical behavior therapy (DBT)|DBT psychotherapy,once a week for three months.
15836257|NCT04154800|Drug|BMS-986209|Oral administration
15836258|NCT04154800|Drug|Placebo|Oral administration
15836259|NCT04154787|Drug|LNP023|Investigation of low and high LNP023 doses
15836260|NCT04154787|Drug|Rituximab|Comparison of rituximab dose
15836261|NCT04154774|Drug|Apalutamide|Apalutamide will be administered orally.
15836262|NCT04154761|Procedure|Resection of inferior vena cava and reconstruction|Resection of inferior vena cava and reconstruction with primary repair, resection with autologous or prosthetic patch repair, and circumferential resection with graft replacement
15836263|NCT04154748|Device|Argon Plasma Coagulation 90W power|
15836264|NCT04154748|Device|Argon Plasma Coagulation 60W power|
15836265|NCT04154748|Drug|Omeprazole 120 mg|
15836266|NCT04154748|Drug|Omeprazole 40 mg|
15836267|NCT04154735|Drug|Fludarabine|A chemotherapy medication commonly used in the treatment of leukemia and lymphoma
15836268|NCT04154735|Drug|Cyclophosphamide|A medication used as chemotherapy and to suppress the immune system
15836269|NCT04154735|Drug|Mesna|A medication used in those taking cyclophosphamide or ifosfamide to decrease the risk of bleeding from the bladder
15836270|NCT04154735|Drug|Alemtuzumab|A protein that kills the immune cells that are thought to be causing Crohn's; it is commonly used in the treatment of leukemia and lymphoma
15836271|NCT04154735|Drug|G-CSF|A glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream
15836272|NCT04154735|Drug|Rifaximin|An antibiotic used to treat irritable bowel syndrome and relapsing C. difficile infection; it inhibits DNA-dependent RNA polymerase
15836273|NCT04154735|Drug|Tacrolimus|A medication which suppresses the immune system and inhibits T-lymphocytes; commonly used to lower the risk of organ rejection following transplant
15836276|NCT04154709|Biological|CTA101|Universal CD19-directed CAR-T cells by a single infusion intravenously will be given in escalating doses.
15836277|NCT04154696|Procedure|Liver transplantation of a graft after assessment by normothermic perfusion|Liver transplantation of a graft after assessment by normothermic perfusion
15836278|NCT04154683|Device|Cellvizio®|use of the Cellvizio® optical biopsy
15836279|NCT04154670|Biological|MGTA-145|MGTA-145 will be given intravenously
15836280|NCT04154657|Procedure|conductance catheter measurement|biventricular parallel conductance catheter measurement at rest and stress conditions, + CMR at rest and stress
15836281|NCT04154644|Device|CryoPop|The new CryoPop device will be tested on women with abnormal cytology. Benchmark testing occurred in the previous study and CryoPop was found to be non-inferior to standard cryotherapy device (MedGyn) in woman with normal cytology.
15836282|NCT04154631|Behavioral|Standard Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)|TranS-C is a psychosocial treatment designed to improve sleep and circadian functioning. It is a modular, psychosocial, skills-based approach. In this study, two version of TranS-C will be tested: Standard and Adapted.
15836283|NCT04154631|Behavioral|Adapted Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)|The Adapted version was derived from Standard TranS-C. It was developed to improve the fit of the treatment with the CMHC context.
15836284|NCT04154631|Other|Usual Care Delayed Treatment|Usual care in the partner CMHCs typically starts with a case manager who co-ordinates care and refers each client for a medication review and to various rehabilitation programs (e.g., health care, housing, nutrition, finding a job, peer monitoring).
15836285|NCT04154618|Device|Continuous wireless vital sign monitoring|Infants will receive wireless vital sign monitoring throughout their birth hospitalization.
15836286|NCT04154605|Device|ClariFix cryotherapy|Bilateral freeze ablation of nasal tissue using the ClariFix device.
15836287|NCT04154605|Device|Sham ClariFix cryotherapy|Bilateral sham ablation procedure using the ClariFix device.
15836288|NCT04154592|Other|Humeral Head Depressor Muscle Co-Activation Training- Experimental Group|In addition to the conservative treatment, humeral head depressor muscle co-activation training will be applied for 14 weeks. Participants in the coactivation group will perform the glenohumeral exercises while recruiting the pectoralis major, latissimus dorsi, and teres major muscles. To achieve this, voluntary recruitment of the pectoralis major, latissimus dorsi, and teres major will be taught prior to the demonstration of the glenohumeral exercises using visual feedback provided by EMG Biofeedback. When recruitment is correctly executed (50% of the maximum voluntary contraction signal), it should be maintained while performing the glenohumeral exercises. This will be confirmed by visualizing EMG signals during the exercise training session. During each appointment with the therapist, participants will be evaluated on their capacity to achieve the exercises while performing co-activation.
15836289|NCT04154592|Other|Control Group|"The American Society of Shoulder and Elbow Therapists' consensus statement on rehabilitation following arthroscopic rotator cuff repair will be used as guideline for rehabilitation of patients (Thigpen, C. A., Shaffer, M. A., Gaunt, B. W., Leggin, B. G., Williams, G. R., & Wilcox III, R. B. (2016). The American Society of Shoulder and Elbow Therapists' consensus statement on rehabilitation following arthroscopic rotator cuff repair. Journal of shoulder and elbow surgery, 25(4), 521-535.).
~Individuals in the control group will use shoulder straps for 6 weeks after arthroscopic shoulder surgery. These patients will be referred to physiotherapy clinics 6th week. Patients between 6 and 20 weeks (a total of 14 weeks) will be admitted to the rehabilitation program according to the guideline mentioned above."
15836290|NCT04154579|Behavioral|HeRe We Arts|Art Therapy interventions to promote health, resilience & well-being will discussed; & experiences such as key chain making, collaging on journal covers, creating sculpture garden will be utilized. Music therapy interventions such as lyric discussion, singing, instrument playing, & music-assisted relaxation techniques will be utilized; & discussion of use of music to elicit positive physical & emotional responses will be held. Drums Alive (drumming & movement) will be used to promote physical activity. Art appreciation will include discussion of public art forms. Journaling will include different techniques for journaling, writing poetry, etc. Theater games such as Password, Press Conference, Props Only, & Draw What You Hear will be utilized. Chair yoga will be introduced as a form of exercise. Education will be provided on the various topics.
15836291|NCT04154579|Behavioral|HeRe We Ed|Educational components and some experiential components will be utilized to educate the participants on health, resilience, well-being, nutrition, healthy eating, weight management, eating disorders, obesity, exercise, physical activity, sleep hygiene and the importance of sleep, mental health, stress management, the importance of improving life satisfaction, holistic approaches, wellness, integrative medicine, complementary and alternative medicine, chronic illness, chronic pain, methods for dealing with chronic versus acute illnesses, changing behaviors and/or maintaining healthy behaviors in order to promote health and stay out of the hospital, and navigating the healthcare system. Specific experiential components will include Chair Yoga and Stress Management Techniques.
15836292|NCT04154566|Other|Aerobic Exercises|Aerobic exercise refers to exercise that involves or improves oxygen consumption by the body. It is the type of activity that uses large muscle groups. Its performance is in a continuous and rhythmic way with a main goal to make the heart and lungs work harder than they do when the person at rest
15836293|NCT04154553|Diagnostic Test|Buccal swab|Pharmacogenetic panel testing is conducted by Stratipharm with the DNA of the buccal swab. TaqMan® polymerase chain reaction is proceeded to express the genetic information. Stratipharm is a product offered by Humatrix Aktiengesellschaft (AG). It consists of a laboratory analysis of approximately 100 pharmacological relevant genetic variations (polymorphisms) in over 30 different genes, which code for transport proteins, metabolizing enzymes, or drug targets.
15836294|NCT04154553|Diagnostic Test|EDTA Blood sample (4.9mL)|Genetic testing of potentially relevant genetic variants using the DNA extracted from the EDTA blood sample.
15836295|NCT04154553|Diagnostic Test|Serum sample (7.5mL)|blood sample to determine the actual levels of the compound in patients on medication assumed to be associated to an observed ADR (phenotype).
15836296|NCT04154553|Other|communication of test results|Certified study pharmacist evaluates and communicates clinically relevant test results to the subject and to the responsible physician
15836297|NCT04154553|Other|unstructured interview|One and six months after the communication of test results, the study center will make a phone call to the patient for an unstructured interview in order to gather information about potential outcomes
15836299|NCT04154527|Other|Pelvic Floor and Abdominal Exercises|two repetitions of each exercise, during exhalation phase
15836300|NCT04154514|Device|A functional electrical stimulation device for post-stroke rehabilitation|Most of the FDA-approved commercial FES devices deliver therapy that targets specific kinematic impairment in the step cycle (e.g., foot drop). Our device will be unique in that it can stimulate many muscles around multiple joints for a more comprehensive and naturalistic restoration of lower-limb motor functions.
15836301|NCT04154501|Drug|CNTX-6016|Oral Dose CNTX-6016
15836302|NCT04154501|Other|Other: Placebo|Oral Dose Placebo
15836303|NCT04154488|Drug|Mavorixafor|Mavorixafor capsules will be administered per dose and schedule specified in the arm.
15836304|NCT04154475|Dietary Supplement|yogurt diet|500 g yogurt/day
15836305|NCT04154475|Dietary Supplement|dairy diet|500 g non-yogurt dairy products
15836306|NCT04154475|Dietary Supplement|standard diet|500 g soya-yogurt
15836307|NCT04154462|Other|Scribes|Section 507 of the MISSION Act of 2018 mandates a two-year pilot of medical scribes in VA specialty clinics and emergency departments. Medical scribes assist health care providers by helping to administratively expedite an episode of care through the recording of patient information and updating patient records. Scribes are trained but non-licensed professionals, often deployed in emergency departments and outpatient clinic settings, that observe and document patient encounters but do not participate in clinical care.
15836308|NCT04154449|Drug|Intranasal insulin|Surgical group Received intranasal insulin, the second group surgical Received placebo and the third group is non surgical do not receive anything.
15836309|NCT04154436|Other|Sodium Bicarbonate (NaHCO3) Plus Solution|Alkaline Solution
15836310|NCT04154436|Other|Water (H2o)|Alkaline Solution
15836311|NCT04154423|Other|Glow! Group Prenatal Care|Glow! is an enhanced group prenatal care model that offers co-located social services provided by established community programs with independent funding streams targeting low-income families. The Glow! group prenatal care model pairs a trained facilitator with a licensed prenatal care practitioner from a practice site to provide billable prenatal care to the practice's own patients. Over the course of 8-10 sessions, 10-12 women (within a 6- week gestational age range) receive prenatal medical care, risk assessments, and social support, and gain knowledge and skills related to pregnancy, birth, and parenting.
15836312|NCT04154423|Other|Individual Prenatal Care with CPSP|Comprehensive Perinatal Services Program (CPSP) is a state-funded program for Medi-Cal eligible families to receive enhanced care and service coordination. Participants assigned to CPSP individual care may participate in the CPSP assessments with a Comprehensive Perinatal Health Worker at their prenatal care site, where individual prenatal care will be provided
15836313|NCT04154410|Other|Analgesia Nociception Index|Non invasive finger tip monitoring before during and 5 minutes after cannulation
15836314|NCT04154410|Other|algiscan|Portable videopupillometer to measure pupillary light reflex (PLR), variation coefficient of pupillary diameter (VCPD), pupillary diameter (PD) fluctuations before, during and 5 minutes after cannulation
15836315|NCT04154397|Device|cerebellar transcranial stimulation|Feedforward-based training benefits from a dynamic postural task by application of cerebellum transcranial electrical stimulation (ctDCS) of different modes (direct current vs. noise vs. sham) were administered using a one-channel direct current stimulator (NeuroConn DC-Stimulator PlusTM) with study mode enabled for single blinding. Following the baseline trial of posture tracking, participants of three groups were seated in a chair for 20 min to receive either active or sham cerebellar tDCS prior to the posture tracking and transfer test phases.
15836316|NCT04154384|Behavioral|Pain Management Strategies|The Life Care Specialist (LCS) teaches evidence-informed behavioral interventions and will work with the patient to develop personalized pain management strategies focused on behavioral education, including progressive muscle relaxation (PMR), the Community Resiliency Model (CRM®), motivational interviewing, and reflective listening.
15836317|NCT04154384|Behavioral|Life Care Specialist (LCS) Intervention|The Life Care Specialist (LCS) uses a two-arm approach to education by initially assessing participants general understanding of opioids upon which targeted education is tailored and applied and secondly, building a longitudinal relationship with each patient to increase the saliency of administered opioid education during postoperative follow-up. Information includes proper disposal, common symptoms of opioid use, signs of dependence and overdose and use of naloxone. Information is disseminated orally with adjunct physical resource guides including visual representations and literature.
15836318|NCT04154384|Other|Clinical Coordination with Referrals|The Life Care Specialist (LCS) can help arrange a referral for the participant, should a medical or social issue be identified during LCS intervention, including mental health services, addiction medicine services, housing insecurity referrals, food insecurity referrals, and amputee support. When giving referrals, the LCS works closely with physicians and nurses to make sure that the participant is a good fit for the referral program.
15836319|NCT04154371|Device|Electromyography-controlled virtual and augmented reality using serious gaming|Surface electrodes and a tracking marker are placed on the subject's affected upper extremity. Electrodes are placed on active muscle sites along the affected extremity determined by palpation. Electrodes are connected to an electromyography recording device, and signal acquisition and processing software are used to record EMG signals and display feedback. Myoelectric signals are used to control a virtual limb on the screen. The intervention consists of different steps: virtual reality, augmented reality, and serious gaming, which the participant must control with their muscle activity, record by EMG, in their affected limb.
15836320|NCT04154358|Diagnostic Test|HPV testing|will perform HPV testing with self-collected specimen
15836321|NCT04154345|Other|Exercise therapy (exercising into pain)|The intervention consists of 12 weeks of progressive loaded exercises, three times per week. There are 9 sessions of supervised physiotherapy treatment, lasting 30 minutes, while the rest of the sessions is conducted as home exercises. There are 4 strengthening exercises, in which the pain allowed ranges between 4 and 7 on a verbal NPRS
15836322|NCT04154332|Other|Sample collection|Blood, urine, and placental samples will be collected from each person enrolled in this study.
15836323|NCT04154319|Behavioral|HPV Vaccination|Mothers assigned to this arm participated in educational/behavior change sessions to promote HPV vaccination among their unvaccinated 9-12 year old daughters
15836324|NCT04154319|Behavioral|Healthy Eating|Mothers and daughters assigned to this arm received education on healthy eating and how to appropriately interpret nutrition labels
15836329|NCT04154280|Diagnostic Test|PET/MR scan|"The PET will be performed with 68Ga-PSMA tracer.
~The 3 tesla magnet of the MRI will be used with sequence allowing MRS acquisition, additional sequences will include T2-weighted contrast and diffusion weighted contrast.
~Images will be analyzed visually and quantitatively. Quantitative analysis will include MR parameters such as DWI apparent diffusion coefficient (ADC) and PET quantitative metabolic data such as standard uptake values (SUV) or Ki (in case dynamic PET protocol will be applied). In addition, content relationship between metabolic entities detected will be extracted.
~Quantitative data will be correlated to clinical and pathological data to check accuracy, specificity and sensitivity."
15836330|NCT04154267|Procedure|Percutaneous renal biopsy.|The biopsy will be performed with a 16 Gauge semi-automatic needle gun for renal biopsy under real-time ultrasound control. After the procedure will be done ultrasound control
15836331|NCT04154254|Diagnostic Test|PET/MR|The PET will be performed with one of the following tracers: 18F-FDG, 18F-DOPA or 18F-flutemetamol (Vizamyl). Proper tracer will be determined by the physician according to the condition. Patients that will agree, will be asked to perform two scans each with different tracer. The 3 tesla magnet of the MRI should allow acquisition of several contrasts within a reasonable time frame. The protocol will include T1 and T2-weighted images, perfusion and diffusion images. Images will be analyzed visually and quantitatively. Quantitative analysis will include MR parameters such as DWI apparent diffusion coefficient (ADC) and PET quantitative metabolic data such as standard uptake values (SUV), metabolic tumor volume (MTV), and total lesion glycolysis (TLG). Hidden image parameters will also be extracted for texture analysis purposes. Quantitative data will be correlated to clinical and pathological data to check accuracy, specificity and sensitivity.
15836332|NCT04154241|Diagnostic Test|PET/MR scan|"The PET will be performed with (68Ga)-labeled somatostatin analogue since it was proven to be superior to other NET PET tracers in terms of lesion detection and sensitivity [11] [12]. The 3 tesla magnet of the MRI should allow acquisition of several contrasts within a reasonable time frame. The protocol will include T1 and T2-weighted images, diffusion-weighted images with multiple b values and apparent diffusion coefficient (ADC) maps.
~All images will be analyzed with big data tools such as radiomics and texture analysis in order to integrate all image parameters and different contrasts into individual tumor status. Then, accuracy, sensitivity and specificity will be evaluated by correlation of this data collection and analysis method with histological biomarkers (for example, Ki67 level) and treatment results."
15836333|NCT04154228|Diagnostic Test|PET/MR scan|"Patients will undergo 18F-FDG PET/CT scans before therapy initiation, interim after 2/3 treatment cycles and end of treatment after therapy completion, as part of their routine evaluation, as well as additional follow-up scans, as clinically indicated and requested by referring physicians. Given signed written informed-consent forms, patients will undergo at each time point, immediately after completion of PET/CT, a PET/MR scan, following the same single injection of 18F-FDG. Standard preparation and acquisition protocols for FDG PET imaging will be employed.
~PET/MR imaging will include conventional sequences as T1, T2, diffusion weighted imaging, and advanced vascular imaging (DCE-MRI)."
15836334|NCT04154215|Diagnostic Test|PET-CT FDG brain scan|"Scans will be performed in Discovery MI PET/CT scanner (by GE). Dynamic FDG PET scan start immediately after a bolus injection of 18F-FDG (0.1 mCi/kg) 5. Dynamic PET scan protocol of 30 min will be follow by a static scan protocol with a duration of 8 min combined with a low dose CT scan.
~The radiation exposure of the patients is equal to the radiation exposure during the routine PET-CT FDG brain scan. The only discomfort to the patient is a longer scan duration.
~After the scan is concluded the patient will be released with no restrictions. Each of the acquired PET images will undergo visual assessment. In addition, quantification of the image data using Standardized Uptake Values (SUV) and kinetic model. The correlation between the clinical information, visual assessment and quantitative parameters will be tested. Sensitivity and accuracy of the quantification methods will be calculated."
15836335|NCT04154202|Other|Bone Scan|Bone Scan: three-phase planar Bone Scan and a SPECT/CT [perfusion, blood pool and SPECT/CT of the relevant region of interest (ROI), and a whole-body planar late bone scan].
15836340|NCT04154176|Other|CAM, Nu-DESC|Two trained raters, who are blinded and have no access to each other's evaluation, administer the CAM and Nu-DESC questionnaires in each shift, during the first postoperative day after the discharge from the post-anaesthesia care unit, independently. The two assessments are completed within 60 minutes of each other. If the research team set the diagnosis of POD, the appropriate treatment will be initiated, according to the Hospital's protocol
15836343|NCT04154150|Drug|Intravenous ketamine|Single subanesthetic infusion of ketamine (0.5mg/kg)
15836344|NCT04154150|Behavioral|Cognitive training|8 sessions of computer-based cognitive training
15836345|NCT04154150|Behavioral|Sham Training|8 sessions of computer-based sham training
15836394|NCT04153747|Diagnostic Test|Daily 30-seconds ECG|Transtelephonic daily 30-seconds single lead electrocardiogram
15836395|NCT04153734|Drug|Pembrolizumab|Pembrolizumab at 200 mg (day 1) will be administered to patients with non-squamous cell carcinoma at 3-week intervals. To those with squamous cell carcinoma, Pembrolizumab at 200 mg (day 1) will be administered at 3-week intervals until disease progression or intolerable toxicity. Pembrolizumab administration should be continued for 2 years involving induction and maintenance therapies or until the 35th course.
15836435|NCT04153422|Drug|Gammagard IVIG|Immune Globulin Infusion 10% (Human)
15836346|NCT04154137|Other|Questionnaire|Enrolled patients will fill out a modified version of a previously validated written questionnaire, including two different sections. The first comprises basic demographic information, including age, sex and ethnicity, and a screening section for symptoms consistent with irritable bowel syndrome (IBS) in accordance with the Rome III criteria, also including their past gastrointestinal, allergic and psychiatric history. The second section enquires for self-reported gluten-related symptoms. Participants will be also asked for their use of a gluten-free diet and if they had seen a healthcare professional for their symptoms. A reported diagnosis of celiac disease and wheat allergy in the population group is defined by those who had a doctor diagnosis of celiac disease and wheat allergy and are also taking a gluten-free diet.
15836347|NCT04154124|Diagnostic Test|PET/MR scan|whole-body PET/CT scan and pelvic PET/MR scan (MR protocol will include three plane fast spin echo T2 weighted, DWI and dynamic contrast enhanced imaging). The ad interim assessment will use a pelvic PET/MR scan only (without PET/CT), to avoid the radiation associated with whole body CT. In the staging and post-nT assessment, the addition of PET/MR to the standard use of PET/CT adds no radiation exposure.
15836348|NCT04154111|Device|Real cTBS to the vmPFC|This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil--double blinded using the Universal Serial Bus (USB) key
15836349|NCT04154111|Device|Sham cTBS to the vmPFC|This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.
15836350|NCT04154111|Device|Real iTBS to the dlPFC|This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key).
15836351|NCT04154111|Device|Sham iTBS to the dlPFC|This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.
15836352|NCT04154098|Device|Scapula orthosis assistance|Participants are elevating their arm while their scapula is assisted by the scapula orthosis
15836353|NCT04154098|Procedure|Manual scapula assistance|Participants are elevating their arm while their scapula is assisted by a trained personnel
15836354|NCT04154098|Other|No assistance|Participants are elevating their arm without being assisted
15836355|NCT04154098|Other|Functional Test|Participants perform a functional test once without (NO) and once with (OA) the orthosis
15836356|NCT04154085|Other|Psychotherapy|Group psychotherapy
15836357|NCT04154072|Drug|NLY01|exenatide and polyethylene glycol (PEG)
15836358|NCT04154072|Drug|Vehicle|Saline (Sodium Chloride)
15836359|NCT04154059|Other|Intervention Group|Patients will receive a physical therapy intervention for strengthening, stretching and functional training of ankle and foot.
15836360|NCT04154046|Procedure|Tenotomy(cutting) of flexor tendons is performed with needle|"Patient is placed in seated posture with feet elevated. The toe(s) with hammer, mallet or claw toe deformity is anesthetized by a digital toe block with 1-5 ml of 1% lidocaine administered for each toe. The toe digital block is administered through a plantar approach, at the web level of the deformed toe(s), with a 0,6 mm diameter and 30mm long needle.
~After anesthetizing the toe(s) the plantar aspect of the toe at web level is disinfected with an alcohol based disinfectant twice.
~Both the long and short flexors are then severed with a 1.2mm diameter and 40mm long needle through a plantar approach, immediately proximal to the web level of the toe.
~After the procedure a dry gauze bandage is applied and the patients treated foot/feet is/are elevated for 20 minutes to achieve haemostasis, and the bandage is checked for bleeding before discharge."
15836361|NCT04154033|Drug|Naltrexone|Topical naltrexone cream (1%)
15836362|NCT04154033|Other|Placebo Cream|Topical placebo cream
15836364|NCT04154007|Diagnostic Test|kidney function tests - urine output|"AKI was classified based on the worst of either creatinine or urine output criterion as follows:
~Stage I 1.5-1.9 times baseline OR ≥0.3 mg/dl increase in the serum creatinine, OR urine output <0.5 ml/kg per hour for 6 to 12 hours.
~Stage II 2.0-2.9 times baseline increase in the serum creatinine OR urine output <0.5 ml/kg per hour for ≥12 hours.
~Stage III 3.0 times baseline increase in the serum creatinine OR increase in serum creatinine to ≥4.0 mg OR urine output of <0.3 ml/kg per hour for ≥24 hours, OR anuria for ≥12 hours OR the initiation of renal replacement therapy."
15836365|NCT04153994|Procedure|Erector Spinae Plane Blockade|The ESPB is fascial plane block performed by injecting local anesthetic between the erector spinae muscle and the transverse process. Its proposed mechanism of action is via blockade of the dorsal and ventral rami of the thoracic spinal nerves and sympathetic fibers.
15836366|NCT04153981|Drug|Insulin Glargine|Administered SC
15836367|NCT04153968|Dietary Supplement|β-cryptoxanthin|"Phase 1:
~2.0mg of [13C14]β-cryptoxanthin, 1.0mg of [13C10]β-carotene and 0.4mg [2H6]retinyl acetate are given in sunflower oil at Time 0.
~Phase 2:
~1.5mg of [13C14]β-cryptoxanthin, 0.75mg of [13C10]β-carotene, 0.4mg [2H6]retinyl acetate are given in sunflower oil along with 0.25mg β-carotene and 0.5mg β-cryptoxanthin from maize are given at Time 0.
~Then, 0.75mg of [13C14]β-cryptoxanthin, 1.5mg of [13C10]β-carotene, and 0.4mg [2H6]retinyl acetate are given in sunflower oil along with 0.5mg β-carotene and 0.25mg β-cryptoxanthin from maize are given on day 21."
15836368|NCT04153955|Behavioral|Mobilization|Any movement out of bed
15836369|NCT04153942|Behavioral|Mobilization|Any movement out of bed
15836396|NCT04153734|Drug|Cis Platinum|In patients with non-squamous histology, cisplatin (75 mg/m2) will be administered every 3 weeks until 4 cycles with pemetrexed and pembrolizumab.
15836397|NCT04153734|Drug|Carboplatin|In cisplatin-intolerable patients, carboplatin (AUC=6) will be administered every 3 weeks until 4 cycles with pemetrexed and pembrolizumab.
15836398|NCT04153734|Drug|Pemetrexed|In patients with non-squamous histology, pemetrexed (500 mg/m2) will be administered every 3 weeks until progression or 2 years after initiation (35 cycles) with pembrolizumab.
15836399|NCT04153734|Drug|nab paclitaxel|In patients with squamous histology, nab-paclitaxel (100 mg/m2, day 1, 8, 15, tri-weekly) will be administered until 4 cycles with pembrolizumab.
15836373|NCT04153916|Device|Neurotrigger eye blinking stimulator|"Phase 1 - The first stage is composed of a one-time participation for about three hours and involves:
~Verifying compliance of the patients with the research inclusion and exclusion criteria
~Completion of the study clinical report form (CRF) for this stage
~Placement of the single use mini-electrodes that will be adhered to the facial skin near the non-blinking eye and coupled to the Neurotrigger stimulator to elicit eyelid closure.
~Participants may be enrolled to the second phase up to one year from the first phase visit In the second stage the duration of the participation is about three weeks (six days a week) and includes daily use of the device for up to 10 hours a day. During nights the patient will continue is standard pattern of either eye closure or leaving the eye open, as the patient used to do prior to the study.
~This stage will involve a patient with a partner that is designated to support the patient closely during the placement and adjustment of the system"
15836374|NCT04153903|Other|OCT, coronary angiography, FFR|Coronary images by OCT and angiography and FFR values will be registered.
15836375|NCT04153890|Behavioral|FamPALcare|"Intervention participants will receive standard care plus five weekly coaching sessions with telephone follow-up to reinforce HF palliative home care. FamPALcare intervention will be delivered by community-based nurses. FamPALcare intervention involves coaching patients and family caregivers in advanced HF home care and supporting EOLPC discussions.
~The standard care group will receive routine HF care and instruction at university hospital or at clinic appointments. All patients can be referred for supportive care and heart failure care per national HF guidelines."
15836376|NCT04153877|Other|Kinesiotape|Kinesio-tape® is an elastic, hypoallergenic, cotton-fiber tape with acrylic heat-activated backing and is widely used within sports.
15836377|NCT04153864|Behavioral|Brief Behavioral Activation Treatment|A manualized 6-8 session BA treatment delivered individually to each participant.
15836378|NCT04153851|Procedure|neurectomy of nasopalatine nerve|Severing of nerurovascular bundle and pushing the nasopalatine canal content nasally and insertion of bone graft in the canal. Dental implant will be inserted in the central incisor location
15836379|NCT04153838|Other|Cognitive test administration|Specifically chosen cognitive tests will be administered to all participants twice; with an approximate 12 month gap between initial testing and follow-up testing.
15836380|NCT04153825|Device|Transcutaneous Electrical Nerve Stimulation|Electrodes are placed around painful regions determined by the patient as patients are in the sitting position with the knees extended. The device is set at pulse duration of 50 to 80 μs; pulse frequency of 50 to 100 Hz; low-intensity (paraesthesia, not painful). The patient wears TENS for a 20-minute duration for each knee.
15836381|NCT04153825|Device|Interferential Current|Electrodes are placed diagonally around the painful areas defined by the patient, with the patient in the sitting position with the knees extended. The device is set at carrier frequency 4000 Hz, amplitude modulated frequency (AMF) 100 Hz, scanning frequency 50 Hz, scanning mode 1: 1 s. The patient wears ICF for a 20-minute duration for each knee.
15836382|NCT04153825|Other|Hydrocollator hot-pack|The hot-pack (at a surface temperature of almost 42 °C) is administered on knees while patients are in sitting position with the knees extended. Every session includes 20 minutes of hot-pack for each knee.
15836383|NCT04153825|Device|Sham transcutaneous Electrical Nerve Stimulation|Electrodes are placed around painful regions determined by the patient as patients are in the sitting position with the knees extended.TENS unit in place but not turned on.The patient wears TENS for a 20-minute duration for each knee.
15836384|NCT04153825|Device|Sham interferential Current|Electrodes are placed diagonally around the painful areas defined by the patient, with the patient in the sitting position with the knees extended. IFC unit in place but not turned on.The patient wears ICF for a 20-minute duration for each knee.
15836385|NCT04153812|Device|vagus nerve stimulation|Vagus nerve stimulation (VNS) is a new technique for stimulating the left cervical vagus nerve through implanted lead and a programmable pulse generator.
15836386|NCT04153799|Biological|CXCR5 modified EGFR Chimeric Antigen Receptor Autologous T cells|The first dose group: 0.5 × 10^6/kg CAR positive T cells; The second dose group: 1.58 × 10^6 / kg CAR positive T cells; The third dose group: 5 × 10^6/kg CAR positive T cells. The above dose allows a 20 % error; For subjects with body weight greater than 60 kg, the number of cells can only be calculated according to 60 kg of body weight.
15836387|NCT04153786|Other|Temporary changes in an already-implanted medical device (biventricular pacemaker)|"During the patient's routine clinic visit, investigators will adjust the patient's pacemaker to four different settings and monitor for any changes in the function of the LVAD.
~The pacemaker will be set to each new setting for 2-5 minutes. After this, the pacemaker will be returned to its original / pre-existing setting, and the patient will leave the clinic with no overall changes to the settings of either the pacemaker or LVAD.
~However, if investigators find that one of the four pacemaker settings results in a clear improvement in the LVAD function, the patient will be given the option of resetting their pacemaker to that new setting before leaving the clinic. In either case, the LVAD settings will not be altered at all. The adjustments will be made by the regular device staff who routinely see the patients and maintain their devices during their regular follow-up clinic visits."
15836388|NCT04153773|Diagnostic Test|OCT|"The degree of physical disability was assessed by using the Expanded Disability Status Scale (EDSS). The EDSS score ranges from 0 to 10 in 0.5 unit increments that represent higher levels of disability.
~Neurocognitive functions were evaluated using the Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) that includes the following tests:
~Symbol Digit Modalities Test (SDMT) that is used for assessment of information processing speed.
~California Verbal Learning Test - 2nd edition (CVLT-II) .
~Brief Visuospatial Memory Test-Revised (BVMT-R)
~OCT assessment was performed by spectral domain-optical coherence tomography to assess the retinal nerve fiber layer thickness and macular volume in humans .
~Each eye for every patient was assessed by measuring the thickness of RNFL and GCC, respecting presence or absence of the previous history of optic neuritis (ON)."
15836389|NCT04153760|Drug|Aspirin 81 mg|Aspirin 81 mg p.o. daily
15836390|NCT04153760|Drug|Placebo|Placebo p.o. daily
15836391|NCT04153747|Other|High-power and short-duration radiofrequency ablatio (70 W / 9-10 s)|Pulmonary veins electrical isolation: high-power and short-duration ablation
15836392|NCT04153747|Other|Low-power (25-40 W) radiofrequency ablation guided by lesion size index (LSI) and ablation index (AI) values|Pulmonary veins electrical isolation: low-power ablation.
15836393|NCT04153747|Other|Esophageal endoscopy|Esophageal endoscopy to detect postablation esophageal thermal lesions.
15836400|NCT04153721|Behavioral|Name Digital Solution|"The digital solution offers a pre-operative program of information (pathology, treatment modalities, protocols to be followed) and training (stress management, psychological support, optional: nutritional preparation, physical exercise, reduction of alcohol and tobacco consumption).
~In the post-operative phase, patients must daily assess their state of health (temperature, weight, wound, nausea / vomiting, urine / stool) and well-being (physical, moral, sleep, pain), from day 1 to day 7 after discharge, to facilitate the detection of complications by the medical team"
15836401|NCT04153708|Behavioral|Retrieval patients lost to follow-up with positive HCV antibodies without RNA request or positive RNA by phone call.|Patients assigned to strategy 1 will be called to schedule an appointment with the hepatologist over a period of 14 days.
15836402|NCT04153708|Behavioral|Retrieval patients lost to follow-up with positive HCV antibodies without RNA request or positive RNA by mail letter|Patients assigned to strategy 2 will receive an invitation letter with an appointment with the hepatologist over a period of 14 days.
15836403|NCT04153695|Other|Music Therapy|to listen flamenco music during 30 minuts per day during 2 weeks
15836404|NCT04153682|Diagnostic Test|Rapid Diagnostic Testing|Automated microbiological diagnostic device based on multiplex PCR analysis, allowing detection of multiple pathogens and resistance markers in one hour from invasive and non-invasive respiratory samples
15836405|NCT04153682|Diagnostic Test|Antimicrobial stewardship|After clinical examination, routine biological tests will be performed. This includes blood culture, direct examination and culture of invasive or noninvasive respiratory samples, urinary antigen tests for Legionella and Pneumococcus, Influenza PCR on nasopharyngeal swabs (during the influenza season).
15836406|NCT04153669|Behavioral|Exercise-NMES|Exercise-NMES
15836407|NCT04153669|Behavioral|Exercise-No NMES|Exercise-No NMES
15836408|NCT04153656|Other|Reading and studying Spiritual Flow|The Wellbeing Inventory will be administered to subjects and they will be compensated upon completion of the survey. Two months after the first survey, the Wellbeing Inventory will be administered to subjects and they will be compensated upon completion of the survey.
15836409|NCT04153643|Procedure|Arthroscopic Partial Meniscectomy|Surgical treatment for meniscus tear
15836410|NCT04153630|Biological|mesenchymal stem cells derived from bone marrow (BM-MSCs)|Procedure: Haploidentical MSCs derived from bone marrow administered by intravenous injection with a dose of 2-3x106 cells / Kg
15836411|NCT04153617|Dietary Supplement|Control honey|Control honey defined as orange blossom honey. Intake daily for 3 months (40 g/day)
15836412|NCT04153617|Dietary Supplement|Modified honey with soluble fiber and polyphenols|Honey modified with soluble fiber and polyphenols, with same organoleptic conditions as control honey. Intake daily for 3 months (40 g/day)
15836413|NCT04153604|Drug|doxycycline|a tetracycline antibiotic that fights bacteria in the body.
15836414|NCT04153565|Drug|Pembrolizumab|Participants will receive PBZ at 200 mg/m2 IV every 3 weeks (Q3W) until disease progression, or until participant has received 35 administrations of PBZ (approximately 2 years)
15836415|NCT04153565|Drug|Pemetrexed|Participants will receive PMX @ 500 mg/m2 IV on Day 1 of each cycle up to 4-6 cycles where each cycle = 3 weeks
15836416|NCT04153565|Drug|Cisplatin|Participants will receive CIS @ 75 mg/m2 IV on Day 1 of each cycle up to 4-6 cycles where each cycle = 3 weeks
15836417|NCT04153552|Dietary Supplement|HLNatural, Inc. Upset Stomach Relief|Supplement to take with mild to moderate indigestion. The degree of your indigestion pre and post will be recorded
15836418|NCT04153539|Behavioral|Walking along a busy road|The intervention group will walk along a busy road and be exposed to traffic-related air pollution for 4.5 hours (from 13:00 to 17:30), while alternating 15-minute walking and 30-minute rest periods.
15836419|NCT04153539|Behavioral|Walking in a traffic-free park|The control group will walk in a traffic-free park for 4.5 hours (from 13:00 to 17:30), while alternating 15-minute walking and 30-minute rest periods.
15836420|NCT04153526|Procedure|Blood sampling|Blood samples will be obtained during routine clinical visits. Ideally, two 9mL blood samples (or equivalent volume) will be collected into EDTA or other appropriate blood collection tube at each time point except at baseline, where three EDTA 9mL tubes and one of 2.6mL (for study of whole blood) will be collected.
15836421|NCT04153526|Procedure|Surplus Tumour Tissue sample collection from surgery|In surgical patients, lung tumour samples and normal lung tissue will be obtained from surplus tissue removed at the time of surgery. No extra procedures (biopsies or surgeries) are requested for the study.
15836422|NCT04153526|Other|Collection or archival tumour tissue (If available)|Where available surplus tumour and normal tissue from archival tissue will be collected for analysis.
15836423|NCT04153513|Drug|Lanolin|Lanolin will be applied by hand in a thin layer to the nipple and areola after every breast feed (approximately every 2 to 3 hours) for a maximum of 7 days or until the symptoms of pain and signs of nipple damage have ceased (if noted before 7 days).
15836424|NCT04153513|Other|Mother's milk|After each breast feed (approximately every 2 to 3 hours), a few drops of breast milk will be applyed to the nipple and areola by hand and allow them to air dry. The treatment will last for up to 7 days or until the symptoms of pain and signs of nipple damage have ceased (if noted before 7 days).
15836425|NCT04153500|Other|Anatomy class with Pelvic+ methodology|Teaching of female pelvis anatomy using a interactive training model (Pelvic+ methodology)
15836426|NCT04153487|Drug|Ascorbic Acid Injectable Product|Intermittent Intravenous Infusion of Ascorbic Acid (Vitamin C) 2.5 gm / 6 hours for 96 hours
15836427|NCT04153487|Drug|Placebo|Placebo saline / 6 hours for 96 hours
15836428|NCT04153474|Procedure|large-bore nephrostomy tube (LBNT)|large-bore 22 french nephrostomy tube (LBNT)
15836429|NCT04153474|Procedure|small-bore nephrostomy tube (SBNT)|small-bore 14 french nephrostomy tube (SBNT)
15836430|NCT04153461|Procedure|MINI-PERCUTANEOUS NEPHROLITHOTOMY|MINIPERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 15 FR, LASER DUSTING OF THE STONE, NEPHROSTOMY TUBE 12 FIXATION
15836431|NCT04153461|Procedure|STANDARD PERCUTANEOUS NEPHROLITHOTOMY|PERCUTANEOUS NEPHROLITHOTOMY USING NEPHROSCOPY 24 FR, ULTRASOUND OR LITHOCLAST DISINTEGRATION OF THE STONE AND FORCEPS EXTRACTION OF THE FRAGMENTS, NEPHROSTOMY TUBE 22 FIXATION
15836432|NCT04153448|Other|Measurement of functional capacity|Functional capacity of participants will be measured with six-minute walk test and sit-to-stand test
15836433|NCT04153435|Drug|Calcium Chloride|Calcium chloride 5 mmol
15836434|NCT04153435|Drug|Sodium chloride 0.9%|Placebo
15836436|NCT04153422|Drug|Placebo|0.9% NaCl prepared as the calculated dose equivalent volume to IVIG.
15836437|NCT04153409|Drug|LAT8881|Two 30 mg capsules of LAT8881
15836438|NCT04153409|Drug|Placebo|Two capsules of placebo
15836439|NCT04153396|Drug|The Treatment group|The local infiltration solution in the treatment group will consist of betamethasone and ropivacaine. For local infiltration, a total of 30 ml solution will be prepared for each group, which will include 0.5ml of compound betamethasone injection(betamethasone propionate 5mg and betamethasone sodium phosphate 2mg per 1ml) added to 14.5ml of saline and 15ml of 1% ropivacaine. The surgeon will perform wound infiltration after induction of anesthesia and before surgery. A total of 10 ml of solution will be injected into each level. The study solution will be injected into the subcutaneous tissue, paravertebral muscles, along with the posterior area around the spinous process, lamina, transverse process and the facet joints, along both sides of the planned incision. The epidural space and intrathecal space will not be infiltrated.
15836440|NCT04153396|Drug|The Control group|The local infiltration solution in the control group will consist of ropivacaine. For local infiltration, a total of 30 ml solution will be prepared for each group, which will include 15ml of ropivacaine added to 15 ml of saline for the Control group. The surgeon will perform wound infiltration after induction of anesthesia and before surgery. A total of 10 ml of solution will be injected into each level. The study solution will be injected into the subcutaneous tissue, paravertebral muscles, along with the posterior area around the spinous process, lamina, transverse process and the facet joints, along both sides of the planned incision. The epidural space and intrathecal space will not be infiltrated.
15836441|NCT04153383|Drug|Milrinone Injection|giving IV milrinone: 50 mcg/kg loading dose by IV push over 10 minutes, then 0.375-0.75 mcg/kg/min IV
15836442|NCT04153370|Device|Airtraq|airtraq video laryngoscope was used for intubation of the infant
15836443|NCT04153370|Device|glidescope|glidescope video laryngoscope was used for intubation of the infant
15836444|NCT04153370|Device|c-mac|c-mac video laryngoscope was used for intubation of the infant
15836445|NCT04153357|Device|airtraq|device entering the oral cavity till visualization of the endotracheal tube entering the vocal cords
15836446|NCT04153357|Device|glidescope|device entering the oral cavity till visualization of the endotracheal tube entering the vocal cords
15836447|NCT04153357|Device|c-mac|device entering the oral cavity till visualization of the endotracheal tube entering the vocal cords
15836448|NCT04153344|Other|Electro-oculogram|Electrophysiological recording of changes in electrical potential across the retinal pigmentary epithelium during successive periods of dark and light adaptation, according to ISCEV standards. Results will comprise dark trough value and light/dark (Arden) ratio.
15836449|NCT04153344|Other|Full-field electroretinogram|Electrophysiological recording of retinal function. Results will comprise amplitudes and latencies of each electroretinography response (dark-adapted 0.01, dark-adapted 3.0, dark-adapted 10.0, dark-adapted 3.0 oscillatory potentials, light-adapted 3.0, light-adapted 3.0 flicker).
15836450|NCT04153331|Other|Nasal swab|Patient included in emergency with a nasal swab
15836451|NCT04153318|Device|full-field optical coherence tomography|Pancreatic tissue sample obtained by EUS-FNB will be used for FFOCT imaging. The Images will be sent to trained pathologists for diagnosis. The same tissue sample will be sent to the pathology department for routine histological examination. Compare the diagnoses made by the 2 different methods.
15836452|NCT04153292|Device|SAPIEN M3 valve and dock|During the procedure a SAPIEN M3 dock and a SAPIEN M3 valve will be implanted via transseptal approach.
15836453|NCT04153279|Biological|CMV-TCR-T cells|Patients with CMV emias or CMV disease will be enrolled, and donor derived CMV-TCR-T(HLA-A*1101\0201\2402) cells will be intravenously infused with a escalated dose of 0.1-1×106 CMV-TCR-T cells. The CMV DNA copies and CMV-TCR-T cell proliferation will be monitored in the scheduled time (day 0, day 4, day 7, day 10, day 14,day 28).
15836454|NCT04153266|Other|No intervention is planned for this study|No intervention was/is planned for this study. The study is questionnaire-based (observational).
15836455|NCT04153253|Drug|Aflibercept Injection [Eylea]|"Three monthly based intravitreal injections were given followed by PRP if the hemorrhage was sufficiently cleared.Intravitreal injection was done in sterile operating room, after sterilization and toweling with application of sterile speculum, Betadine 5% drops was instilled into the conjunctiva and kept for two minutes followed by wash with balanced salt solution. Injection of 2mg /0.05m aflibercept was given 4 mm from the limbus in phakic eyes and 3.5 mm in pseudophakic with compression by sterile cotton tip on the site of injection, Paracentesis was done in cases of very high IOP following injection. At the end of procedure check of visual acuity was done (to be at least light perception).
~PRP was done if the hemorrhage is sufficiently cleared after the third injection."
15836456|NCT04153253|Procedure|Vitrectomy|Was done under local peribulbar anesthesia. After sterilization and toweling, wash with diluted betadine 5% was done. Insertion of three 23 valved cannulas beginning with the lower temporal one for infusion, clearance of anterior vitreous was done followed by core vitrectomy, peripheral vitrectomy , removal of posterior hyaloid aided by triamcinolone staining , trimming and removal of any vascular epicenters followed by vitreous base shaving with 360 scleral indentation, endolaser treatment was done for all eyes followed by fluid air exchange, 20% SF6 was used only if there is active significant bleeding during surgery or if there is intraoperative retinal tears, removal of cannulas was done at the end of surgery. All eyes received combination of topical steroid and antibiotic eye drops as postoperative treatment.
15836457|NCT04153240|Device|The Night Shift™ Sleep Positioner (Advanced Brain Monitoring, USA)|The Night Shift™ Sleep Positioner (Advanced Brain Monitoring, USA) has been developed for adult patients with positional OSA, and snorers. Worn on the back of the neck, it begins to vibrate when the patient starts to sleep in the supine position and increases in intensity until the patient changes.
15836458|NCT04153227|Diagnostic Test|Bone mineral density (BMD)|Bone mineral density (BMD) measured by Dual-energy X-ray absorptiometry (DXA).
15836459|NCT04153214|Behavioral|cycling|Participants will have a portable pedal machine under their desk and will use it 60minutes per day
15836460|NCT04153201|Drug|Hydroxychloroquine|Hydroxychloroquine 200 mg daily for patients weighing < 60 kg, hydroxychloroquine 400 mg daily for patients weighing >= 60 kg
15836461|NCT04153188|Device|The Vbeam® Prima System|3 monthly Vbeam® Prima PDL treatments with a 3-day washout of topical Oxymetazoline HCL 1% cream before each treatment.
15836462|NCT04153188|Drug|Oxymetazoline HCL 1% Cream|Daily application of Oxymetazoline HCL 1% cream for the 6-month study.
15836463|NCT04153175|Combination Product|ICV delivery of CT-010 via an implantable pump and a cranial port and dual lumen catheter (CIC)|Subjects will be implanted with a drug delivery pump and catheters leading to the ICV space allowing delivery of CT-010.
15836464|NCT04153175|Combination Product|Placebo delivery via an implantable pump and a cranial port and dual lumen catheter (CIC)|Subjects will be implanted with a drug delivery pump and catheters leading to the ICV space allowing delivery of a placebo (saline).
15836465|NCT04153162|Device|Stereotactic body radiation therapy|Stereotactic body radiation therapy delivered to reduce LVOTO in patients with HCM
15836468|NCT04153136|Drug|Sacubitril-Valsartan 49-51Mg Oral Tablet|By mouth twice daily
15836469|NCT04153136|Drug|Placebo oral tablet|Placebo oral tablet By mouth twice daily
15836470|NCT04153123|Drug|Epinephrine|
15836471|NCT04153110|Device|Anodal cerebellar and cathodal spinal tDCS|10 sessions of anodal cerebellar and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks)
15836472|NCT04153110|Device|Sham cerebellar and sham spinal tDCS|10 sessions of sham cerebellar and sham spinal transcranial direct current stimulation (5 days/week for 2 weeks)
15836473|NCT04153084|Drug|Polyethylene Glycol 4000 with electrolytes|The high volume electrolytes PEG will be administered at a 4 mg/kg dose the day before the procedure in 4-8 hours.
15836474|NCT04153084|Drug|PEG-3350 with electrolytes|The low volume electrolytes PEG will be administered at a 4 mg/kg dose the day before the procedure in 4-8 hours.
15836475|NCT04153084|Drug|Sodium picosulfate|"The Sodium picosulfate will be administered the day before the procedure at different doses depending on the patient´s age:
~From 1 to 2 years old: ¼ sachet reconstituted in ¼ glass of water/juice in the afternoon (15:00 h) and ¼ sachet reconstituted in ¼ glass of water/juice 6 hours later (21:00 h)
~From 2 to 4 years old: ½ sachet in ½ glass of water/juice in the afternoon and ½ sachet in ½ glass of water/juice at night.
~From 4 to 9 years old: 1 sachet in 1 glass of water/juice in the afternoon and ½ sachet in ½ glass of water/juice at night.
~Of 9 years old and older: 1 sachet in the afternoon and 1 sachet at night."
15836476|NCT04153071|Device|OPUS system|Each subject will have a single cutaneous treatment of their lower abdomen, with variable treatment parameters. Punch biopsies will be obtained from each treatment section, for in-vivo histological evaluations.
15836477|NCT04153058|Procedure|Robotic Assisted AEG Radical Gastrectomy|Robotic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma
15836478|NCT04153058|Procedure|Laparoscopic Assisted AEG Radical Gastrectomy|Laparoscopic Assisted Radical Gastrectomy for Advanced Siewert II/III Esophagogastric Junction Adenocarcinoma
15836479|NCT04153045|Device|Radiograph interpretation for pulmonary abnormalities|"The pulmonary abnormalities detected by xrAI and included in the definition of abnormality are as follows: any linear scar or fibrosis, atelectasis, consolidation, abscess or cavity, nodule, pleural effusion, severe cases of emphysema and COPD (mild cases with hyperinflation but not significant emphysema are not flagged), pneumothorax.
~Participants in the treatment group will interpret 500 images presented alongside the results of xrAI's processing in a dark room and asked to categorize each image into one of the following categories: lungs are clear, at least one pulmonary abnormality is present, not sure.
~Participants in the control group will be asked to interpret the same 500 images as the treatment group but without xrAI's analysis."
15836480|NCT04153032|Drug|Diltiazem|DTZ is a calcium channel blocker for the treatment of chronic anal fissure
15836481|NCT04153032|Drug|Mebo|Moist exposed burn ointment (MEBO) is a tropical Chinese medicine composed of sesame oil and herbal plants that is clinically used for the treatment of burn wound.
15836482|NCT04153019|Other|Psychoeducational and rehabilitative intervention|Psycho-educational session: 3 weekly face-to-face consultations between a dyads and trained nurses, helping them to cope with cancer cachexia strengthening dyadic coping resources; 2) Rehabilitation program: 3 sessions with physiotherapists including educational component for patients self-management on physical activity and goal-setting, personalized program of exercises stretching and relaxation + 3 home sessions per week, self-managed by dyads.
15836483|NCT04153006|Device|POC troponin analysis.|Point-of-care (POC) high sensitive troponin I (HS cTnI) analysis in whole blood, plasma and capillary whole blood with the Minicare® device.
15836484|NCT04152993|Device|NeuroPace® RNS® System|All the subjects in this study will receive the experimental treatment. The treatment consists in a surgery to implant the Responsive Neurostimulation (RNS) device in the amygdala bilaterally. Subsequent programming of the RNS aims to reduce fear-related signals.
15836485|NCT04152980|Drug|Pentoxifylline|The intervention consists of intravenously administered pentoxifylline. Pentoxifylline , a methylxanthine, is an off patent drug for neonates and currently registered for peripheral artery disease treatment in adults. Pentoxifylline acts as a cyclic adenosine monophosphate(cAMP)-phosphodiesterase inhibitor that suppresses tumor necrosis factor alfa (TNF-α) and modulates important parts of the inflammatory response and also reduces the production of other inflammatory cytokines, such as IL-1α, IL-6, and IL-8.
15836488|NCT04152954|Device|Radiofrequency ablation of cervical medial branches|Radiofrequency ablation of cervical medial branches
15836489|NCT04152941|Drug|Olaparib|Patients with histologically confirmed ovarian cancer, primary peritoneal cancer and / or fallopian-tube cancer treated with olaparib in a real life-setting, between May 2014 to March 2017, whatever the line of therapy
15836582|NCT04152148|Biological|1000mg BAT4306F|Phase 1 dose titration study from BAT4306F 500mg to 1000mg, then choose a proper dose for amplification study based on DLT result
15836627|NCT04151771|Other|Usual outpatient pulmonary rehabilitation|The control group will perform outpatient pulmonary rehabilitation as established.
15836490|NCT04152928|Diagnostic Test|PET/MR scan|The patient will be positioned in the PET/MR with the field of view of the PET including the abdomen, and IV administration of 68Ga-DOTATATE will take place, with initiation of dynamic PET simultaneous with start of IV injection. Dynamic PET imaging will consist of 22 time frames of increasing durations (6 x 10, 3 x 20, 3 x 60, 5 x 180, and 5 x 300 s). The dynamic PET examination will be followed by a whole-body PET/MR scan ranging from the proximal femur to the base of the skull (3 min per bed position) starting at 60 min after injection. MR will be used for attenuation correction of the PET images of the abdomen/pelvis and whole-body. MR protocol will include three plane fast spin echo T2 weighted, DWI, DCE and ASL. The addition of PET/MR to the standard use of PET/CT adds no radiation exposure.
15836491|NCT04152915|Drug|Semaglutide|Increasing doses of semaglutide administered s.c. (subcutaneouly, under the skin) once weekly for 7 weeks
15836492|NCT04152902|Other|Objective outcome|The final outcome of surgical therapy was assessed according to a semi-quantitative scale graded as excellent, good, fair and poor, according to quantitative grades for dysphagia, reflux symptoms and oesophagitis
15836493|NCT04152902|Other|Quality of life|SF-36 Questionnaire
15836494|NCT04152889|Drug|Camrelizumab|Camrelizumab, 200 mg solution intravenously for 30 min in first day every 3 weeks. Repeated every 21 days. 21 days for a cycle.
15836495|NCT04152889|Drug|S-1|Tegafur-gimeracil-oteracil potassium: 80 - 120 mg bid orally in 14 days, followed by 7 days off. Rrepeated every 21 days. 21 days for a cycle.
15836496|NCT04152889|Drug|Docetaxel|Docetaxel: 40 mg/m^2 solution intravenously for 1 hour in first day every 3 weeks. Repeated every 21 days, 21 days for a cycle, from second cycle to seventh cycle.
15836497|NCT04152863|Biological|V937 IV|Administered as an IV infusion of 1 X 10^9 TCID50
15836498|NCT04152863|Biological|V937 ITu|Administered as an ITu injection of 3 X 10^8 TCID50
15836499|NCT04152863|Drug|Pembrolizumab|Administered as an IV infusion of 200 mg
15836500|NCT04152850|Behavioral|Lifestyle Medicine|Lifestyle intervention with components including physical activity, diet, relaxation/mindfulness, sleep and Traditional Chinese Medicine
15836501|NCT04152837|Drug|Lixivaptan|Oral vasopressin V2 antagonist
15836502|NCT04152824|Behavioral|Resilience-Supportive Leadership Training (RESULT)|Leaders will receive a training addressing supportive supervisor behaviors and resilience
15836503|NCT04152811|Behavioral|Cooking Matters for Diabetes|Each Cooking Matters course is made up of 6, 2-hour, weekly classes with 15 participants. The curricula is based on the Dietary Guidelines for Americans, MyPlate, the American Diabetes Association Standards of Medical Care in Diabetes 2017 and Medical Nutrition Therapy Evidence Based Guide for Practice/Nutrition Protocol as the foundation for basic nutrition guidelines, then builds upon these ideas using the collective groups' needs and interest to provide interactive lessons to teach cooking, food safety and food resource management with emphasis placed on blood sugar management.
15836504|NCT04152811|Other|Usual Diabetes Care|Usual Diabetes Care
15836505|NCT04152798|Procedure|Laparoscopic hiatal hernia repair with ProGrip™ mesh|Suturing of the right and left diaphragmatic crura using 3 to 4 interrupted nonabsorbable stitches with additional reinforcement of crura repair with ProGrip™ mesh
15836506|NCT04152798|Procedure|Laparoscopic primary posterior crural repair|Posterior cruroraphy will be performed with 3 to 4 interrupted non-absorbable sutures
15836507|NCT04152785|Behavioral|Information regarding GHG and/or nutrition|Participants will have to select a meal from a menu.
15836508|NCT04152772|Device|transcranial direct current stimulation|Active tDCS will consist of 15 minutes of 2 mA intensity once, either applied during or after extinction learning.
15836509|NCT04152759|Drug|Drug: BAT2506 injection Other Names: Simponi(EU-licensed)|"Drug: BAT2506 injection Each subject will receive single subcutaneous injection of 50 mg BAT2506 Injection or Simponi(EU-licensed).
~Other Names:
~Simponi(EU-licensed)"
15836510|NCT04152746|Other|Periostin level|The serum periostin levels were planned to compare between the serum samples that were obtained from the two groups. The evaluation of the periostin levels of adenoid tissue and normal healthy mucosa were also planned.
15836511|NCT04152733|Device|High flow nasal cannula|Oxygen is supplied via high flow nasal cannula. Heated air (2L/kg/min) is administered using Optiflow device (Fisher and Paykel Healthcare, Auckland, New Zealand).
15836512|NCT04152720|Device|Foley catheter|"If the subject is enrolled in this clinical trial, the test and control devices will be applied at baseline. All subjects will receive a urinary catheter at the site of the artificial bladder and the urethra after surgery, and temporary urinary replacement should be selected by the investigator at each institution in preparation for the possibility of postoperative blockage of the urinary catheter.
~After surgery, urine analysis and culture are performed on the 4th and 7th day, and urine analysis and culture are performed before the urethral catheter removal on the 14th (2 weeks) and the urethral catheter is removed. At this time, the urethral catheter tip is cut about 5-8 cm and cultured."
15836513|NCT04152707|Device|Splendor X|The Splendor X has two wavelengths in one system: Nd:YAG (1064nm) and Alexandrite (755nm).
15836514|NCT04152694|Other|Ceftaroline levels in CRRT|Levels of ceftaroline measured in patients receiving CRRT
15836515|NCT04152681|Drug|Apatinib|Apatinib with a dosage of 250mg once daily for 4 weeks, in the absence of unacceptable toxicity or severe deterioration.
15836516|NCT04152668|Procedure|Titanium curette.|Implant debridement.
15836517|NCT04152668|Procedure|Ultrasonic|Implant debridement.
15836518|NCT04152668|Procedure|Air-polishing|Implant debridement and polishing.
15836519|NCT04152655|Drug|Idebenone|30mg tablets three times a day
15836520|NCT04152655|Drug|Placebo oral tablet|placebo tablets three times a day
15836521|NCT04152642|Device|Marketed Dry Mouth Rinse|relieves dry mouth symptoms by physically coating oral mucosal surfaces.
15836522|NCT04152642|Other|Water control|negative control
15836523|NCT04152642|Device|Experimental Dry Mouth Rinse|relieves dry mouth symptoms by physically coating oral mucosal surfaces.
15836524|NCT04152629|Drug|Methylphenidate Hydrochloride|CR Methylphenidate Hydrochloride given once daily (25 mg, 35 mg, 45 mg, 55 mg, 70 mg, 85 mg or 100 mg)
15836525|NCT04152629|Drug|Lisdexamfetamine Dimesylate|Lisdexamfetamine Dimesylate given once daily (10 mg, 20 mg, 30 mg, 40 mg, 50 mg or 60 mg)
15836626|NCT04151771|Other|Low-load blood flow restriction training|The intervention group will perform the exercises of the lower limbs using LL-BFRT with an occlusion pressure of 70% of arterial occlusion pressure with low training loads (30% of the 1 repetition maximum).
15836526|NCT04152616|Other|Instrumental evaluation of posture|"After a time of installation of the Optitrack® device's and two accelerometers (one placed on the subject's trunk facing the sternum fixed with a headband and the second at the level of the head also held with a headband), the subject will perform an evaluation of the balance sitting on the sensor pad; the movements of the head and trunk will be analyzed by the Optitrack® device and by the two accelerometers.
~The subject will perform 4 30-second tests, two with eyes open and two with eyes closed. A rest period may be taken between each assessment depending on the subject.
~During these evaluations, a physiotherapist will be present to avoid the risk of falling.
~After a rest period of 30 minutes, a new assessment of the sitting posture will be carried out to assess the reproducibility of the tools (sensor pad, accelerometers, Optitrack®)."
15836527|NCT04152603|Behavioral|Intervention to demonstrate respect|This intervention will be designed based on outcomes from interviews and focus groups that will identify specific actions with the potential to demonstrate respect in the recruitment and consent process. Potential interventions include but are not limited to: research staff training, messaging related to inclusivity, messaging related to voluntariness, additional ethical oversight or other autonomy protections, and guidelines for researchers about study design.
15836528|NCT04152590|Device|Uincare|Interactive digital healthcare system
15836529|NCT04152577|Drug|R2-combination chemotherapy|"R2-CHOP/CHOPE/DA-EPOCH/HD MTX
~R2-CHOP :
~lenalidomide 25mg/d po D1-10; Rituximab：375mg/m2，ivgtt，D0 Cyclophosphamide 750mg / m2 d1, doxorubicin 70mg / m2 or Doxorubicin liposome 30-40 mg / m2 d2, vincristine 1.4mg / m2 or vindesine 3mg / m2 d2, prednisone 100mg d1-5
~R2-DA-EPOCH:
~lenalidomide 25mg/d po D1-10; Rituximab：375mg/m2，ivgtt，D0 Epirubicin 15mg／m２ ,d1-4; Etoposide 50mg／m２ ,d1-4; Vincristine 0.4mg/ ｍ２ ，d1-4; Cyclophosphamide 750mg/ ｍ２ , d５; Prednisone 60mg/m２/d, d1-5;
~R2-HD MTX:
~lenalidomide 25mg/d po D1-10; Rituximab：375mg/m2，ivgtt，D0； MTX 3.5g／ｍ２,ｄ1"
15836530|NCT04152577|Drug|R-combination chemotherapy|"R-CHOP/CHOPE/DA-EPOCH/HD MTX
~R-CHOP :
~Rituximab：375mg/m2，ivgtt，D0 Cyclophosphamide 750mg / m2 d1, doxorubicin 70mg / m2 or Doxorubicin liposome 30-40 mg / m2 d2, vincristine 1.4mg / m2 or vindesine 3mg / m2 d2, prednisone 100mg d1-5
~R-DA-EPOCH:
~Rituximab：375mg/m2，ivgtt，D0 Epirubicin 15mg／m２ ,d1-4; Etoposide 50mg／m２ ,d1-4; Vincristine 0.4mg/ ｍ２ ，d1-4; Cyclophosphamide 750mg/ ｍ２ , d５; Prednisone 60mg/m２/d, d1-5;
~R-HD MTX:
~Rituximab：375mg/m2，ivgtt，D0； MTX 3.5g／ｍ２,ｄ1"
15836531|NCT04152564|Procedure|levo-bupivacaine infusion via Thoracic epidural catheter|The epidural catheter will be placed via a paramedian approach as close as possible to the surgical procedure via the inter-vertebral space (from T7 to T10) so that the affected dermatomes of the surgical wound would receive the benefits of bupivacaine infusion
15836532|NCT04152564|Procedure|levo-bupivacaine infusion via preperitoneal catheter|At the end of surgery and after the closure of the peritoneal layer, the catheter will be allocated above the peritoneum within the musculofascial layer and secured to the skin with an occlusive dressing
15836533|NCT04152551|Drug|Risedronate Oral Tablet|Oral bisphosphonate
15836534|NCT04152538|Other|not intervention but investigation|possible differences in quadriceps muscular activity
15836535|NCT04152525|Other|Psychoeducation|The mindfulness-based education programme that was conducted by the researcher and aimed at increasing self-efficacy in substance addicts was conducted within eight sessions, 2 days a week for 4 weeks.
15836536|NCT04152512|Behavioral|Questionnaire administration|Questionnaire administration (4 different forms: pre-treatment, 3-4 months after treatment, 1 year after treatment, 2-5 years (yearly) after treatment
15836537|NCT04152499|Drug|SKB264|SKB264 is an Antibody Drug Conjugate (ADC) targeting TROP2 expressing cancer cells.
15836538|NCT04152486|Biological|Ad26.ZEBOV, MVA-BN-Filo vaccine|"Ad26.ZEBOV: a monovalent vaccine expressing the full-length glycoprotein (GP) from Ebola virus (EBOV) Mayinga. The vaccine is produced in the human cell line PER.C6®.
~MVA-mBN226B: further referred to as Modified Vaccinia Ankara (MVA)-BN®-Filo. This is a multivalent vaccine expressing the EBOV GP, the Sudan virus (SUDV) GP, the Marburg virus (MARV) Musoke GP, and the Taï Forest virus (TAFV, formerly known as Côte d'Ivoire ebolavirus) nucleoprotein (NP). The EBOV GP expressed by MVA BN Filo has 100% homology with the one expressed by Ad26.ZEBOV."
15836539|NCT04152473|Drug|Proglumide|oral CCK receptor antagonist
15836540|NCT04152460|Device|Viscalor Bulk (VOCO,Cuxhaven)|Viscalor Despenser (Preheating dispenser for composite Viscalor Bulk Caps)
15836541|NCT04152460|Other|Grandioso x-tra|Nanohybrid Bulk Resin Composite
15836542|NCT04152447|Device|VR device|Patients use a VR device
15836543|NCT04152434|Drug|Erenumab Auto-Injector|Assess synergy of add on medication to Erenumab
15836544|NCT04152421|Other|Software use|"The patient will connect to a computerized platform to access the program. The program consists of 5 modules (lessons), each lasting approximately 40 minutes. Each module or lesson includes pedagogical assessments and explanations of the problem(s) in question, illustrations, testimonies, tips, exercises and recommended activities."
15836545|NCT04152408|Device|FiberSense System|FiberSense system, a novel CGM system, based on a fiber-optical sensor placed through the dermis of the patient.
15836546|NCT04152395|Other|EVAR|Patients undergoing EVAR
15836553|NCT04152369|Procedure|Anti-microbial prophylaxis for an endourological procedure or ESWL|anti-microbial prophylaxis according to urine culture results
15836554|NCT04152356|Drug|PD-1|PD-1 (programmed death receptor 1), an important immunosuppressive molecule, is an immunoglobulin superfamily and is a membrane protein of 268 amino acid residues. It was originally cloned from apoptotic mouse T cell hybridoma 2B4.11. Immunomodulation targeting PD-1 has important implications for anti-tumor, anti-infective, anti-autoimmune diseases and organ transplant survival. Its ligand PD-L1 can also be used as a target, and the corresponding antibodies can also play the same role. PD-1 and PD-L1 bind to initiate programmed cell death of T cells, allowing tumor cells to gain immune escape.
15836625|NCT04151784|Other|Healthy Control|The second group will be recruited as a control group consisting of healthy adult participants through purposive convenience sampling at other collaborating UAB sites. The principal investigator will collect self-report responses through a questionnaire packet given to anyone willing to participate in the study
15836555|NCT04152356|Drug|Sorafenib|Sorafenib tosylate is a novel multi-target anti-tumor drug developed by Bayer Pharmaceuticals, Germany, which acts on both tumor cells and tumor blood vessels. It has a dual anti-tumor effect: it directly inhibits tumor cell proliferation by blocking RAF/MEK/ERK-mediated cell signaling pathways, and also by inhibiting VEGFR and platelet-derived growth factor (PDGF) receptors. Blocking the formation of tumor neovascularization, indirectly inhibiting the growth of tumor cells.
15836556|NCT04152343|Device|RFA Physics Library -- a Planning and Guidance Platform (PGP)|Research software used to support liver RFA of HCC lesions >2cm
15836557|NCT04152330|Other|Early stimulation protocol on neuropsychomotor development of children with congenital heart disease|A parent guidance booklet will be prepared. It will contain a specific program of stimulation activities for each stage of development in simple language and with illustrations. Subdivided into 4 areas: Cognition, Language, Broad Motor, and Fine Motor. The duration will be 6 months, with intervention at 30 days and 3 months. Parents will attend 2 individual meetings, where they will receive information and clarifications on the application of the booklet. Parents will be advised about the capabilities and limitations of their babies according to the congenital heart disease the child has, as well as what is expected within the typical development for that age group, and the importance of early stimulation activities in each child. one of 4 development areas. They will be informed about the need for that stimulus for the baby's development, as well as possible doubts about the stimulus.
15836558|NCT04152317|Drug|Misoprostol 200mcg Tab|In the misoprostol 200mcg group there will be one tablet of 200mcg and three identical tablets in shape, size and color without pharmacological properties. These four tablets will be single dose administered via vaginal route for each participant.
15836559|NCT04152317|Drug|Misoprostol 800mcg Tab|In the misoprostol 800mcg group there will be four tablets of 200mcg. These four tablets will be single dose administered via vaginal route for each participant.
15836560|NCT04152304|Other|Sinex program (neuromuscular training program)|The SINEX program is a three months neuromuscular training program aiming to increase neuromuscular stability of the shoulder
15836561|NCT04152291|Dietary Supplement|Ethyl-Eicosapentaenoic Acid (E-EPA)|3,9 grams of EPA is added to participants' normal diet.
15836562|NCT04152278|Diagnostic Test|cervicovaginal culture and qPCR for chlamydial trachomatis and wadallia chondrophila|three cervicovaginal swabs were obtained: one was used for a smear test of vaginal fluid pH evaluation and direct microscopy, the second swabs, cultured for aerobic and anaerobic bacteria and yeasts, the third was eluted in 2-sucrose-phosphate (2SP) based transport medium. Placental samples from the study group were cultured for aerobic and anaerobic bacteria. Placenta sample and 2SP medium were stored at -80°C until their analysis by real time PCR (qPCR)
15836563|NCT04152265|Procedure|colonoscopy|colonoscopy
15836564|NCT04152265|Other|questionnaires|complete the two questionnaires (Food Frequency Questionnaire (FFQ) and the questionnaire of The World Health Organization Quality of Life (WHOQOL-BREF)
15836565|NCT04152265|Other|demographic data collections|completing the demographic questionnaire
15836566|NCT04152265|Other|anthropometric data collections|For the determination of anthropometric data will be used a professional body mass composition analyser (Seca,Hamburg, Germany)
15836567|NCT04152265|Procedure|Collecte the biological samples|blood and faeces collections
15836568|NCT04152252|Other|Real time feedback|Real-time feedback on chest compression depth, chest compression rate and recoil available to EMS while performing CPR. Feedback is delivered as visual text, numeric and graphical presentations on the defibrillator with audio tones for rate.
15836569|NCT04152252|Behavioral|Post-event debriefing|Structured oral post-event debriefing based on objective performance data from the resuscitation attempt. The debriefing is conducted as hot/immediate self-directed debriefing session with a maximum length of 10 minutes.
15836570|NCT04152239|Procedure|Motorized spiral enteroscopy (MSE)|Endoscopic Procedures MSE is a 1.6m enteroscope equipped with a single-use short spiral overtube propelled by a user-controlled motor contained in the handle of the endoscope. The endoscopist controls the left-right and up-down movements by the usual manuvers while the forward or backward advancement of the enteroscope would be contolled by a foot pedal that activates the spiral overtube rotation. Antegrade MSE, retrograde MSE, or combined antegrade and retrograde MSE would be performed as clinically indicated for diagnostic +/- therapeutic procedures.
15836571|NCT04152226|Drug|J. Lividum|Investigational Product
15836572|NCT04152213|Behavioral|Low GI diet|This educational session will cover information on obesity, complications of obesity, the benefit of weight loss, the glycemic index and its associated low GI diet, a food-exchange table including high- to low-GI foods, and self-decision in food choices. The dietary advice will be based on the standard food pyramid for the conventional Chinese diet as promoted by the Hong Kong Department of Health, with an emphasis on the selection of low-GI products. Practical tips will be given such as the selection of low-GI rice and rice products, the impact of cooking methods (including cooking time, cooking conditions, and cooking liquid volume) on rice GI, intervention to reduce the GI of rice, and listing low-GI food options and meal plans.
15836574|NCT04152187|Other|Inspiratory muscle training|The treatment group will receive inspiratory muscle training.
15836575|NCT04152174|Procedure|Combined extracorporeal blood purification|Patients receive combined extracorporeal blood purification: CRRT in CVVHDF mode with AN 69 ST set (Baxter) and hemoadsorption with Cytosorbents Corp. CytoSorb adsorber.
15836576|NCT04152174|Procedure|CRRT|Patients receive CRRT in CVVHDF mode with AN 69 ST set (Baxter)
15836577|NCT04152161|Biological|BCG vaccine SSI|Participants will receive a single 0.1 milliliter (mL) volume of BCG vaccine SSI, administered intradermally in deltoid region of the upper arm.
15836578|NCT04152161|Biological|Placebo|Participants will receive a single 0.1 mL volume of normal saline, administered intradermally in deltoid region of the upper arm.
15836579|NCT04152148|Biological|500mg BAT4306F|Phase 1 dose titration study from BAT4306F 500mg to 1000mg, then choose a proper dose for amplification study based on DLT result
15836580|NCT04152148|Biological|750mg BAT4306F|Phase 1 dose titration study from BAT4306F 500mg to 1000mg, then choose a proper dose for amplification study based on DLT result
15836581|NCT04152148|Biological|900mg BAT4306F|Phase 1 dose titration study from BAT4306F 500mg to 1000mg, then choose a proper dose for amplification study based on DLT result
15836583|NCT04152135|Procedure|vena cava inferior diameter measurement|Ultrasound equipment with convex probe will be used to measure IVC diameters of the patients in supine position.The IVC sagittal section is described with the probe in the area of subxiphoid. IVC diameters at the junction point of the IVC and right atrium (2cm caudal) are standardized measurement.
15836584|NCT04152122|Diagnostic Test|The dynamic stereopsis test|The characteristics of preoperative dynamic stereopsis in 83 intermittent exotropia patients and its associations with clinical features were analysed, and the prognosis was followed up on the 1st day and 2nd, 6th and 12nd months postoperatively.
15836585|NCT04152109|Procedure|Laying on hands with Spiritual connection|Laying on hands with spiritual connection by mediators intended to heal the patient
15836586|NCT04152096|Drug|Rheosorbilact®|Administered intravenously (with speed 40-60 drip per minute) at a dose of 600 to 1,000 ml (10 to 15 ml/kg body weight per 24 hours) for 3 days.
15836587|NCT04152096|Drug|Ringer lactate|Administered intravenously (with speed 40-60 drip per minute) at a dose of 1,000 to 2,500 ml (15 to 40 ml/kg body weight per 24 hours) for 3 days.
15836588|NCT04152083|Drug|Eptinezumab|Injection for IV administration
15836589|NCT04152083|Drug|Placebo|Injection for IV administration
15836590|NCT04152070|Other|No intervention|There was no intervention to be administered, only collection of data through various tests and questionnaires.
15836591|NCT04152057|Drug|Pyrotinib Maleate Tablets|400mg/d,po qd,q3w, 4 cycles
15836592|NCT04152057|Drug|Albumin Paclitaxel|125mg/m2,ivggt,d1,q3w,4 cycles.
15836593|NCT04152057|Drug|Trastuzumab|The first week load dose 4mg / kg, followed by 2mg / kg per week, d1,ivggt,q3w,4 cycles.
15836594|NCT04152044|Other|Observation of different types of obesity and liver pathology in patients undergoing and oesophagectomy|Patinets undergoing surgery
15836595|NCT04152031|Other|Prompting|Participants receive medication reminders on a smartphone. The reminders are generated through machine learning algorithms that automate the process of medication prompting according to successful medication contexts that occurred in the past.
15836596|NCT04152018|Drug|PF-06940434|PF-06940434 is given intravenously (IV) every 2 weeks in a 28 day cycle. Multiple dose levels will be evaluated
15836597|NCT04152018|Drug|PF-06801591|PF-06801591 will be administered subcutaneously on Day 1 of each 28 day cycle.
15836598|NCT04152005|Other|Observation|Evaluation of ET-1 level and correlation of ET-1 levels with periodontal and cardiovascular disease
15836599|NCT04151966|Diagnostic Test|Blood sample collection|Blood sample collection for markers of myocardial injury
15836600|NCT04151953|Diagnostic Test|Blood sample collection|Blood sample collection for markers of myocardial injury
15836601|NCT04151940|Procedure|Positron Emission Tomography|Undergo PET/CT scan
15836602|NCT04151940|Procedure|Computed Tomography|Undergo PET/CT scan
15836603|NCT04151940|Drug|Chemotherapy|Receive standard of care chemotherapy
15836604|NCT04151940|Biological|Immunotherapy|Receive standard of care immunotherapy
15836605|NCT04151940|Radiation|Radiation Therapy|Undergo standard of care radiation therapy
15836606|NCT04151927|Device|Normobaric Hypoxia|Low oxygen exposure to mimic ~8500 feet elevation.
15836607|NCT04151927|Device|Normobaric Normoxia|Normal oxygen exposure to mimic ~1000 feet elevation (sham comparator).
15836608|NCT04151901|Other|Resistance Exercise Rehabilitation|Following disuse, the REHAB groups (M-REHAB, F-REHAB) will complete monitored resistance exercise rehabilitation sessions using an isokinetic dynamometer at a similar relative load at each rehab visit.
15836609|NCT04151901|Other|Walking-based rehabilitation|Following disuse, the CON groups (M-CON, F-CON) will complete 30 minutes of monitored walking at a moderate intensity at each rehab visit.
15836610|NCT04151888|Device|Foley catheter|Thin sterile tube will be inserted in choana
15836611|NCT04151875|Device|Extraction orthodontic treatment|orthodontic treatment with teeth extraction
15836612|NCT04151875|Device|Non-extraction orthodontic treatment|Non-extraction orthodontic treatment
15836613|NCT04151862|Device|tight eye bandage|sterile eye pad made of 100% cotton
15836614|NCT04151862|Device|Soflex Soft Contact Lens|Therapeutic contact lenses (TCL)
15836615|NCT04151849|Drug|GLP-1 receptor agonist|Treatment with GLP-1 agonist for up to 1 year.
15836616|NCT04151849|Drug|SGLT2 inhibitor|Treatment with SGLT2 inhibitor for up to 1 year
15836617|NCT04151836|Other|Exercise education|"weekly telephone or mobile application LINE consultations concerning exercise. we discussed whether participants' exercise fulfilled the prescribed intensity, duration, or frequency and whether the participants experienced any adverse effects."
15836618|NCT04151823|Drug|Vitamin D3|2 ml per day SMART D3 MATRIX Smartfarma S.r.l. Via San Vittore 40 - 20123 MILAN: 2 mL of product will give 1600 UI/die of VIT D3.
15836619|NCT04151823|Drug|Immunofos|Postbiotics will be given at the dose of 80 mg/day. immunofos from Lactobacillus paracasei CNCM I-5220).
15836620|NCT04151823|Other|Promotion of physical activity|Promotion of physical activity will be encouraged at t0, t1, t2
15836621|NCT04151823|Other|Healthy food habits promotion|Promotion of healthy food habits will be encouraged at t0, t1, t2
15836622|NCT04151810|Drug|CDP1|"Single-dose Phase: Cohort 1:400mg/m2;Cohort 2: 500mg/m2;Cohort 3: 750mg/m2;
~Multi-dose Phase:Cohort 1 Dosing regimen is the first administration of 400mg/m2, followed by 250mg/m2/W;Cohort 2,3 Dosing regimen is the first administration of 500mg/m2, followed by 500mg/m2/2W."
15836623|NCT04151797|Other|Medication therapy management|"The intervention is in the form of a pharmacist-led medication review aimed at detecting potentially inappropriate prescribing. It includes:
~Data collection on comorbidities, medication and laboratory results.
~A pharmacist's evaluation of the prescriptions based on the patient's conditions and on the current recommendations for clinical practice.
~A detailed feedback to the geriatrician.
~A written report addressed to the attending physician"
15836624|NCT04151784|Other|Pulmonary Group|Data collection will be obtained on the day an individual has an appointment at the pulmonary clinic. After patients meet with their pulmonary physicians, the physicians will inform them about the study and explain that participation is voluntary. If a patient agrees, the researcher will provide copies of the questionnaires and again clarify that participation is voluntary. The workflow of the clinic will not be interrupted while the researcher conducts the study, and he will only ask participants to fill out the questionnaires if they have enough time to participate.
15836628|NCT04151758|Drug|Docosahexaenoic Acid Supplementation|Docosahexaenoic Acid (DHA) will be given at the dose of 500 mg/day (2 ml per day DHA RICH OIL 25% aroma mandorla FoodAR Limbiate, Italy;50% DHA oil obtained from Schyzochitrium sp ; Martek Biosciences Corporation, Columbia, Maryland, USA) to all participants of the study. DHA 2 ml will provide about 16 kcal of energy.
15836629|NCT04151758|Other|Promotion of physical activity|All participants will underwent a visit at t0, t1 and t2 in which physical activity will be promoted according to Italian dietary guidelines for childhood obesity.
15836630|NCT04151758|Other|Promotion of healthy food habits|All participants will underwent a visit at t0, t1 and t2 in which healthy food habits will be promoted according to Italian dietary guidelines for childhood obesity.
15836631|NCT04151745|Procedure|external pacemaker switched off|When a hemodynamically stable state is achieved, the external pacemaker will be switched off for 30 minutes. Hemodynamic parameters will be acquired directly prior to switching off, 15 respectively 30 minutes after switching off, and 15 minutes after switching back on. To gain insight in the natural course of stunning, this routine will be repeated the next morning.
15836632|NCT04151732|Behavioral|Physical activity, alcohol, tobacco|Physical activity, alcohol, tobacco - selfreported in the 1990's
15836633|NCT04151732|Other|Hormonal factors|Hormonal factors - selfreported in the 1990's
15836634|NCT04151732|Other|Cardiovascular disease|Cardiovascular disease - selfreported in the 1990's
15836635|NCT04151732|Other|Anthropometric measures|Height, length, BMI
15836636|NCT04151719|Drug|Methylnaltrexone bromide (MNTX)|Methylnaltrexone bromide will be administered per dose and schedule specified in the respective arm.
15836637|NCT04151706|Drug|CD8+ Memory T Cell Infusion|Allogeneic phenotypic CD8+ memory T cells from HLA matched donors infused at the time of hematopoietic cell transplantation
15836638|NCT04151706|Drug|Thiotepa|5 mg/kg/day: IV for 2 consecutive days (days -6 to -5)
15836639|NCT04151706|Drug|Fludarabine|25 mg/m2/day: IV for 5 consecutive days (days -6 to -2)
15836640|NCT04151706|Radiation|Hyperfractionated TBI|Administered in 11 fractions of 125 cGy over 4 days (Total dose of 1375 cGy)
15836641|NCT04151706|Drug|Busulfan|6 mg/kg/dose Q24h IV. Infused over 3 hours. 1 dose per day x 4 consecutive days x 3.6 mg/kg/dose = 14.4 mg/kg
15836642|NCT04151706|Drug|Cyclophosphamide|60 mg/kg/dose Q24h IV. Infused over 2 hours. 1 dose per day x 2 consecutive days x 60 mg/kg/dose = 120 mg/kg
15836643|NCT04151693|Behavioral|CBT-based group therapy for patients with chronic fatigue syndrome (CFS)|Goal is to relief patients anxiety and offer to learn better coping skills in situation where patients functioning in everyday life is difficult.
15836644|NCT04151680|Drug|Intermittent administration of dabigatran, rivaroxaban, apixaban, or edoxaban|Patients will receive intermittent treatment with a novel oral anticoagulant drug
15836645|NCT04151680|Drug|Chronic administration of dabigatran, rivaroxaban, apixaban, or edoxaban|Patients will receive chronic treatment with a novel oral anticoagulant drug
15836646|NCT04151667|Drug|Daratumumab Injection|Patient will receive daratumumab (1800 mg in 15 ml) administered by manual subcutaneous injections weekly for the first 8 weeks, every other week for the next 16 weeks and every 4 weeks after.
15836647|NCT04151667|Drug|Dexamethasone Oral|The dexamethasone starting dose will be 20 mg PO once a week. Commercial dexamethasone will be used. Dexamethasone is often supplied in 4 mg tablets. Accordingly, patients will take 5 (4 mg tablets) one day of the week prior to the administration of daratumumab if this corresponds to a daratumumab dosing days. In non daratumumab dosing days, dexamethasone will be taken by the patient at home, usually in the morning with breakfast.
15836648|NCT04151667|Drug|Lenalidomide Pill|"Lenalidomide will be given orally on days 1-21 of a 28 days cycle. The starting dose of lenalidomide will be based on the patient creatinine clearance per the package insert.
~Specifically patients with a creatinine clearance ≥ 50 ml/min will receive 25 mg of lenalidomide PO Days 1-21. Patients with a creatinine clearance ≥ 30 but less than 50 ml/min will receive 10 mg of lenalidomide.
~Patients with a creatinine clearance < 30 ml/min are not eligible but patients who experience a deterioration in the renal function during screening or treatment may continue on lenalidomide therapy as long as the risk / benefit profile is deemed acceptable, that study therapy is in the best interest of the patient and after discussion with the study principal investigator / sponsor."
15836649|NCT04151667|Drug|Bortezomib Injection|Bortezomib will be given weekly subcutaneously in an effort to decrease the toxicity of the therapy. Specifically patients will receive a starting dose of bortezomib of 1.3 mg/m^2 Days 1,8,15 of a 28 day cycle. Bortezomib will be administered in the cancer center per standard of care procedures.
15836650|NCT04151654|Other|Footwear Assessment Score|It was assessed using the Sharpened Romberg test and Single Leg Stance test for static balance. It was assessed Berg Balance Scale for dynamic balance, and Timed Up and Go test for functional performance. Balance and performance tests were done with and without footwear in all individuals.
15836651|NCT04151641|Dietary Supplement|MNGDPF|Standardized mangosteen extract in dry powder form
15836652|NCT04151641|Dietary Supplement|MNGEF|Standardized mangosteen extract in encapsulated form
15836653|NCT04151628|Device|Lithotripsy|Deliver Lithotripsy to the target vessel prior to placing a coronary stent
15836654|NCT04151602|Behavioral|Smoked illicit drug use|The exposure of interest is current smoked illicit drug use, particularly methamphetamine and/or methaqualones
15836655|NCT04151589|Behavioral|ANGEL Intervention Package and Toolbox|The interventional measures include emergency work flow management app on smartphone, specialized training, assessment of quality improvement outcomes and feedback on a regular basis, patient-centred management frame based lean six-sigma, and other specialised approach.
15836656|NCT04151576|Other|aromatherapy massage|aromatherapy massage
15836657|NCT04151563|Biological|nivolumab|Specified dose on Specified days
15836658|NCT04151563|Biological|ipilimumab|Specified dose on Specified days
15836659|NCT04151563|Drug|cabozantinib|Specified dose on Specified days
15836660|NCT04151563|Biological|docetaxel|Specified dose on Specified days
15836661|NCT04151563|Biological|ramucirumab|Specified dose on Specified days
15836662|NCT04151563|Drug|lucitanib|Specified dose on Specified days
15836777|NCT04150679|Procedure|hepaticojejunostomy without access loop|ROUX en Y hepaticojejunostomy without access loop
15836664|NCT04151537|Behavioral|Personal Activity Intelligence|The intervention group is provided with a PAI monitor (wristband) with a user interface (app) to track their own PAI level and are instructed to obtain at least 100 PAI on a weekly basis.
15836665|NCT04151537|Behavioral|Physical Activity Guidelines|The control group is recommended to follow national PA guidelines, meaning 150 minutes of moderate-intensity PA or 75 minutes of vigorous-intensity PA, or a combination there of. The control group is provided with a PAI monitor (wristband) without any user interface and are thus blinded to track their own PAI level.
15836666|NCT04151511|Procedure|Continuous Erector Spinae Plane Block|"Continuous Thoracic Epidural Thoracic Epidural Analgesia
~Continuous Erector Spinae Plane Block"
15836667|NCT04151498|Behavioral|Reengagement and Assessment Mobile Program|Participants will participate in mobile clinic visit that will include an educational interview, adherence counseling, and standard blood draws for HIV reengagement. The goal of this intervention is to motivate participants to become reengaged in traditional HIV care by making an in person clinic appointment.
15836668|NCT04151498|Other|Qualitative Interview|Qualitative interview about barriers and facilitators to HIV care, and experience at most recent clinic visit.
15836669|NCT04151485|Behavioral|Mind/Body Program for Fertility (Domar et al., 2011)|see Arm Description
15836670|NCT04151485|Behavioral|Fertility Support Program|see Arm Description
15836671|NCT04151472|Drug|Placebo|Placebo oral tablet, three times a day
15836672|NCT04151472|Drug|90mg Idebenone|Idebenone 30 MG Oral Tablet, three times a day
15836673|NCT04151472|Drug|270mg Idebenone|Idebenone 90 MG Oral Tablet, three times a day
15836674|NCT04151459|Drug|Metformin|Use Metformin for 3 months to treat PCOS
15836676|NCT04151433|Procedure|Comparison between 2 different laparoscopic techniques in conservative surgical treatment of endometriomas (both arms are existing and accepted surgical strategies).|cf. different arms
15836677|NCT04151420|Other|Remote monitoring tool (infections questionnaire) validation|"There will be no treatment intervention in the current study (no drugs will be used). Instead, patients are enrolled in a routine care eHealth care-pathway with myIBDcoach. MyIBDcoach (MijnIBDcoach, Dutch, Sananet Care B.V., Sittard, The Netherlands, https://www.mijnibdcoach.nl) is a web-based platform for home-monitoring and patient- provider communication in patients with IBD.
~Patients already using the myIBDcoach will be informed on this study. Patients will be asked to continue routine care including monitoring of PROs through the myIBDcoach. When a patient completes the infections disease questionnaire for the first time, this will be regarded as the starting point (T=0) for this patient. Patients will complete the questionnaire every three months after the starting point as part of their routine follow-up. Results from these questionnaires will be stored electronically and will be analyzed alongside medical records of GP's and drug delivery data from pharmacies."
15836678|NCT04151407|Drug|Drug 601|Drug is a kind of recombinant anti-VEGF humanized monoclonal antibody injection.
15836679|NCT04151394|Procedure|Duodenojejunostomy|Resection of duodenal lesions and reconstruction by duodenojejunostomy
15836680|NCT04151381|Drug|Aminophylline|"the control group (n =15 ) the patients will receive 20 ml of normal saline IV ,20 minutes before induction of general anesthesia .
~Amiopphylline 2mg:(n = 15) the patients will receive 2 mg/kg intravenous (IV) aminophylline diluted in 20 ml normal saline 20 minutes before induction of general anesthesia .
~Aminophylline 4mg: (n = 15) the patients will receive 4 mg/kg intravenous (IV) aminophylline diluted in 20 ml normal saline 20 minutes before induction of general anesthesia .The study drugs will be given by an anesthetist unaware of the study protocol."
15836681|NCT04151368|Procedure|Robotic Nipple-Sparing Mastectomy (RNSM)|RNSM will be performed by previously described method using 3 cm extra-mammary axillary incision along the mid-axillary line in the axillary fossa. We will use Da Vinci Si Surgical System® (Intuitive Surgical, Sunnyvale, CA).
15836682|NCT04151355|Drug|Atorvastatin 20mg|atorvastatin (20 mg once daily)
15836683|NCT04151342|Drug|Cancer treatment with tyrosine kinase inhibitors (TKIs)|Observing cancer patients who have received or are currently receiving tyrosine kinase inhibitors (TKIs) for their cancer treatment.
15836684|NCT04151342|Other|Patient-reported outcomes (PROs)|Prospectively enrolled participants will be provided with survey packets comprised of different PRO instruments at the initial/baseline visit, at 3 month follow up intervals and at the time when treatment/therapy is changed.
15836685|NCT04151329|Biological|BAT1306 and BAT8001 2.4mg/kg|Phase 1 dose titration study of BAT1306 and BAT8001 2.4mg/kg , then choose a proper dose for amplification study based on DLT result
15836686|NCT04151329|Biological|BAT1306 and BAT8001 3.6mg/kg|Phase 1 dose titration study of BAT1306 and BAT8001 3.6mg/kg , then choose a proper dose for amplification study based on DLT result
15836687|NCT04151316|Procedure|crown preparation|includes tooth preparation
15836688|NCT04151316|Procedure|vertical preparation|type of vertical preparation on the tooth that accepts the crown
15836689|NCT04151316|Procedure|horizontal preparation|type of horizontal preparation on the tooth that accepts the crown
15836690|NCT04151303|Procedure|Cervical cerclage|Cervical cerclage and cervical cerclage removal
15836691|NCT04151277|Drug|FOLFOX-A|Patients will recieve nab-paclitaxel, oxaliplatin, Folinic Acid and 5-FU in a 14 day cycle
15836692|NCT04151277|Drug|Gemcitabe and Abraxane|Patients will receive gemcitabine and nab-paclitaxel 3 weeks out of 4
15836693|NCT04151277|Drug|G-CSF|Patients in the FOLFOX-A arm will also receive daily G-CSF as primary prophylaxis for all cycles. This will be given as per local site policy for 14 day chemotherapy regimens
15836694|NCT04151264|Device|Hypotension probability index (HPI)|The intervention group is managed with the HPI parameter to detect and possibly prevent hypotension during anaesthesia.
15836695|NCT04151251|Behavioral|Patient Empowerment|Group to receive a 5 minute video about typical hospital sleep disruptions and what they can do to prevent them, as well as a brochure outlining the importance of sleep
15836696|NCT04151251|Other|Sleep Kit|Patients receive a small pouch that includes an eye mask, ear plugs, and headphones, all to be used to aid in falling/staying asleep
15836697|NCT04151238|Behavioral|Exercise intervention for cancer patients to increase physical activity during chemotherapy|The duration of the exercise intervention is eight (8) weeks. There will be guided endurance and muscle power training two (2) time weekly. The participants will also be provided with one training program per week for use at home.
15836698|NCT04151225|Drug|GSK2330811|GSK2330811 will be available as SC injection with a unit dose strength of 150 mg/mL. GSK2330811 will be available in single-use pre-filled syringe.
15836699|NCT04151225|Drug|Placebo|Placebo will be available as SC injection of 0.9 percent saline solution. It will be available as single-use pre-filled syringe.
15836700|NCT04151212|Drug|BAT5906 injection|Signal dose escalation starting from 0.3mg. Route of administration: intravitreal injection
15836701|NCT04151199|Other|Endurance Training|Participants randomized to EE training engage in three school-based or center-based (PERC) EE training sessions each week for approximately 12 weeks; each session lasting roughly 70 min with a 45-50 minutes of a stimulus phase and the remaining time being used to warm-up and cool down.
15836702|NCT04151186|Biological|TM4SF1- and EpCAM-positive chimeric antigen receptor T-cell therapy|"Specification: 30 mL-100 mL, cell density of about (1-10) x10^6 cells/ml in each bag, number of T-cells about (1-10) x10^8 cells.) 300 ml for each infusion.
~Storage: The prepared CAR T-cells are cryopreserved in a preserving medium . This product is manufactured under the current good manufacture practices (cGMP) conditions, with restrictions on chemical components, free from animal- or human-derived components and confirming to the United States Pharmacopeia (USP)<71> and <85> regulations.
~Preservation: The frozen CAR T-cells are preserved in the liquid nitrogen transfer tank.
~Usage: The frozen CAR T-cells are preserved at low temperature and transferred to the bedside. The cells are thawed by 36 degrees centigrade to 38 degrees centigrade. water bath. The frozen cells are gently massaged until complete thawing. Then they are transfused back to the patients intravenously. The transfusion will be finished within 5-10 min."
15836703|NCT04151173|Procedure|laparoscopic aspiration/electrocoagulation|laparoscopic aspiration/electrocoagulation of ovarian endometrioma
15836704|NCT04151173|Procedure|laparoscopic cystectomy|laparoscopic cystectomy of ovarian endometrioma
15836705|NCT04151160|Diagnostic Test|Point of care ultrasound measurements|i. Ultrasound images will be obtained using a commercial, high frequency, linear Philips ultrasound probe attached to small, portable tablet. This tablet will have the capability of transferring the saved images to the secure MuscleSound cloud-based server.
15836706|NCT04151147|Procedure|Concentrated Growth Factor (Test group)|The patients' blood was collected in 9 ml glass tubes and immediately centrifuged to prevent coagulation in special centrifuge device. The CGF program was set up as follows: accelerated for 30 seconds so as to reach 2700 rpm, rotated for 2 minutes, then reduced to 2400 rpm, then rotated again for 4 minutes and accelerated to 2700 rpm, rotated for 4 minutes, then accelerated to 3000 rpm for 3 minutes, and decelerated for 36 seconds to stop. The middle layer in the tube was separated by the ''Buffy coat'' containing the CGFs fibrin gel using forceps and scissor. Then, this fibrin gel was inserted in the extraction cavity.
15836707|NCT04151147|Procedure|Non-Concentrated Growth Factor (Control group)|Third molar extraction was performed under local anesthesia. Following the extraction, the socket was sutured and natural healing process was observed. This side was considered as a control group.
15836708|NCT04151134|Diagnostic Test|Step serial sectioning histological processing|Step serial sectioning histological processing
15836709|NCT04151121|Behavioral|MBCT (Mindfulness Based Cognitive Therapy)|MBCT is recognized behavior therapy for patients with recurrent depression. The program will be adapted for patients with chest pain.
15836710|NCT04151108|Other|Development of a risk assessment tool based on clinical and functional measures and systemic biomarkers|Blood tests, frailty (CSHA Clinical Frailty Scale) and risk of pressure ulcers (Braden Score), Early Warning Score (EWS), sarcopenia (SARC-F), malnutrition (SNAQ), cognitive status, comorbidity (Charlson comorbidity Index), polypharmacy, muscle strength, and body composition (BIA)
15836711|NCT04151108|Other|Development of a risk assessment tool for loss of muscle mass and physical function based on clinical and functional measures and systemic biomarkers|Blood tests, frailty (CSHA Clinical Frailty Scale), Early Warning Score (EWS), cognitive status, sarcopenia (SARC-f), malnutrition (SNAQ), comorbidity (Charlson comorbidity Index), polypharmacy, physical function, physical performance, and body composition (BIA)
15836712|NCT04151095|Other|BFR Exercise Training|Participants will complete exercise training on a recumbent bike placed on a 45 degree incline (BFR).
15836713|NCT04151095|Other|CTL Exercise Training|Participants will complete exercise training on a recumbent bike placed on flat ground (CTL).
15836714|NCT04151082|Drug|Methylprednisolone|Given IV
15836715|NCT04151082|Drug|Prednisone|Given PO
15836716|NCT04151082|Other|Quality-of-Life Assessment|Ancillary studies
15836717|NCT04151082|Other|Questionnaire Administration|Ancillary studies
15836718|NCT04151069|Other|Procedure A|Up-dosing nut drink at home
15836719|NCT04151069|Other|Procedure B|Up-dosing nut drink at the hospital
15836720|NCT04151069|Other|Control group|Strict avoidance of tree nut consumption
15836721|NCT04151043|Behavioral|Suggestions|Verbal suggestions or no suggestions about treatment outcome
15836722|NCT04151043|Device|Deep brain stimulation|Regulation of deep brain stimulation intensity
15836723|NCT04151030|Procedure|PEG placement|Push PEG placement
15836724|NCT04151017|Other|Autologous fibrin glue|Conjunctival graft fixation with autologous fibrin glue
15836725|NCT04151017|Other|Suture|Graft fixation using 10.0 mononylon
15836726|NCT04151004|Other|Incremental cycling test (ICT)|Incremental cycling test to volitional exhaustion
15836727|NCT04151004|Other|Constant load cycling test (CET)|Constant load cycling test to volitional exhaustion.
15836728|NCT04151004|Other|Incremental respiratory muscle test (IncRMET)|Incremental respiratory muscle test to volitional exhaustion.
15836729|NCT04151004|Other|Incremental quadriceps muscle test (IncQMT)|Incremental quadriceps muscle test to volitional exhaustion.
15836730|NCT04151004|Other|Respiratory muscle training like interventions|Three different respiratory muscle training like interventions that are usually used for respiratory muscle trainings.
15836731|NCT04150991|Other|Fiber intervention|Each subject will supplement his/her normal dietary intake with 35 grams of dietary fiber daily for three consecutive weeks.
15836732|NCT04150991|Other|Placebo treatment|Each subject will supplement his/her normal dietary intake with an 18.53-g maltodextrin placebo daily for three consecutive weeks.
15836733|NCT04150978|Other|High Protein Polymeric Formula|Component: 22.4% protein from total calorie Preparation of Peptisol: 5 spoons of Peptisol powder diluted in 200 ml warm water to have 250 ml Peptisol (equal to 250 kcal). Given as written in the group descriptions
15836734|NCT04150978|Other|Oligomeric Formula|Component: Component: 22.4% protein from total calorie Preparation: 5 spoons of Peptamen powder diluted in 165 ml warm water to have 200 ml Peptamen (equal to 200 kcal). Given as written in the group descriptions
15836735|NCT04150978|Drug|5% Dextrose|500 ml of 5% Dextrose administered to a peripheral vein.
15836736|NCT04150965|Drug|Elotuzumab, pomalidomide, dexamethasone|Study Patients with relapsed Multiple Myeloma will receive: Elotuzumab, Pomalidomide, and Dexamethasone Starting in Phase 2 Cycle 1 Day 1 forward. Each cycle is 28 days long.
15836737|NCT04150965|Drug|Anti-LAG-3|"Patients with relapsed Multiple Myeloma will receive: Anti -LAG-3 single agent for Cycle 1. Each Cycle is 28 days
~Cycle 2 forward patients will receive Anti-LAG-3 in combination with pomalidomide and dexamethasone from Cycle 2 forward. Each cycle is 28 days long."
15836738|NCT04150965|Drug|Anti-LAG-3 + Pomalidimide + Dexamethasone|Patients with Relapsed & Refractory Multiple Myeloma will receive: Anti-LAG-3 in combination with pomalidomide and dexamethasone from Cycle 2 forward. Each cycle is 28 days.
15836739|NCT04150965|Drug|Anti-TIGIT|"Patients with relapsed Multiple Myeloma will receive: Anti -TIGIT single agent for Cycle 1.
~Each cycle is 28 days."
15836740|NCT04150965|Drug|Anti-TIGIT + Pomalidimide + Dexamethasone|Cycle 2 and beyond patients will receive Anti-TIGIT in combination with pomalidomide and dexamethasone from Cycle 2 forward. Each cycle is 28 days..
15836741|NCT04150952|Other|HRV-based training|Intervention based on HRV-guided training for the performance improvement of athletes. Pre-competitive HRV, subjective effort perception, anxiety and mood will also be analysed.
15836742|NCT04150952|Other|TRAD training|Traditional endurance training
15836743|NCT04150939|Procedure|Core Biopsy|Undergo core biospy
15836744|NCT04150939|Procedure|Cryosurgery|Undergo cryoablation
15836745|NCT04150939|Drug|Immunotherapeutic Agent|Receive standard of care immunotherapy
15836746|NCT04150926|Other|Black currant|"The effect of black currant puree will be compared with black currant-quinoa product, quinoa base and with liquid with glucose, fructose and sucrose
~Experimental: Black currant and quinoa product
~Active Comparator: Quinoa base Meal study comparing the effect of black currant puree with liquid with glucose, fructose and sucrose, black currant and quinoa product and quinoa base"
15836747|NCT04150926|Other|Black currant-quinoa product|The effect of black currant puree will be compared with black currant-quinoa product
15836748|NCT04150926|Other|Quinoa base|The effect of black currant puree will be compared with quinoa base
15836749|NCT04150913|Drug|Anakinra|Subcutaneous, dosage per protocol. Day 0 through Day 6.
15836750|NCT04150913|Drug|Axicabtagene Ciloleucel|Once, intravenous infusion, dosage per protocol
15836751|NCT04150900|Drug|Bavituximab|Bavituximab is a chimeric (human/mouse) monoclonal antibody (mAb) derived from murine mAb 3G4 that targets phosphatidylserine (PS) after binding to β2-glycoprotein 1 (β2-GP1).
15836752|NCT04150900|Drug|Pembrolizumab|Pembrolizumab is a highly selective humanized mAb designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
15836753|NCT04150887|Drug|Cusatuzumab|Cusatuzumab will be administered as a dose of 10mg/kg or 20mg/kg intravenously.
15836754|NCT04150887|Drug|Azacitidine|Azacitidine will be administered 75 mg/m^2 subcutaneously or intravenously.
15836755|NCT04150887|Drug|Venetoclax|Venetoclax will be administered orally and the dose will ramp-up to 400 mg.
15836756|NCT04150874|Diagnostic Test|Lumason®|Hepatic artery embolization using standard of care radioembolization and assessment of tumor and hepatic parenchymal perfusion kinetics before, during and after treatment with standard of care iodinated contrast (at the time of Y90 radioembolization treatment) and standard of care follow-up with multiphase CT or MRI with the addition of study agent Lumason microbubbles for contrast-enhanced ultrasound (which will be performed concurrently with standard evaluation).
15836757|NCT04150861|Drug|Follitropin Delta|Solution for Injection, subcutaneous administration
15836758|NCT04150848|Behavioral|Goal-Focused Emotion Regulation Therapy (GET)|Six sessions delivered individually over 8 weeks
15836759|NCT04150848|Behavioral|Individual Supportive Psychotherapy (ISP)|Six sessions delivered individually over 8 weeks
15836760|NCT04150835|Drug|Xingnaojing injection|Xingnaojing injection (20 ml)+0.9% diluted sodium chloride injection 250ml, IV (in the vein), every 12 hours for 10 days.
15836761|NCT04150835|Drug|Xingnaojing placebo injection|Xingnaojing placebo injection (20 ml)+0.9% diluted sodium chloride injection 250ml, IV (in the vein), every 12 hours for 10 days.
15836762|NCT04150835|Other|Standard care|Guidelines-based standard care for acute ischemic stroke.
15836763|NCT04150822|Other|Registry and Saliva sample|Non-interventional registry with saliva sample collected for DNA analysis
15836764|NCT04150809|Other|No intervention|There is no intervention for this study
15836765|NCT04150796|Procedure|Ventral Hernia Repair|Participants will undergo robotic ventral hernia repair according to the assigned treatment arm.
15836766|NCT04150783|Procedure|Surgical repair for nasal obstruction|Patient reported quality of life questionnaires
15836767|NCT04150770|Drug|infliximab|
15836768|NCT04150757|Drug|Intranasal ketamine|Patients with vaso-occlusive episode and sickle cell disease in moderate to severe pain determined at triage will receive intranasal ketamine while awaiting IV placement.
15836769|NCT04150744|Combination Product|radiofrequency ablation|take advantage of RFA to destroy hepatocellular carcinoma by high temperature
15836770|NCT04150731|Radiation|16α-18F-fluor-17β-estradiol|16α-18F-fluor-17β-estradiol PET/CT scan
15836771|NCT04150718|Behavioral|slow-wave disruption|A tone will be played through a speaker mounted over the bed that disrupts subjects while they are in slow-wave sleep. The tone will not be loud enough to wake up.
15836772|NCT04150705|Device|FDG PET/MRI|-All patients will undergo a simultaneous list mode PET and MR acquisition beginning 55-65 minutes after administration of FDG according to a standard weight-based scale.
15836773|NCT04150692|Biological|Dara-SC|-Subcutaneous daratumumab and hyaluronidase-fihj
15836774|NCT04150692|Procedure|Blood for research assessments|-Cycle 1 Day 1, Cycle 3 Day 1, and at progression or end of study (whichever is first)
15836775|NCT04150692|Procedure|Bone marrow for research assessments|-Cycle 1 Day 1, Cycle 3 Day 1, and at progression or end of study (whichever is first)
15836776|NCT04150679|Procedure|duodenojejunostomy access loop|ROUX en Y hepaticojejunostomy with duodenojejunal anastomosis as permanent access
15836778|NCT04150666|Dietary Supplement|Hydration|the same with arm descriptions
15836779|NCT04150653|Device|Multiphase scan CT, non-invasive vascular ultrasound elastography by ultrasound (NIVE)|Multiphase scan CT, non-invasive vascular ultrasound elastography by ultrasound (NIVE)
15836780|NCT04150640|Drug|Nal-IRI|chemotherapy drug
15836781|NCT04150640|Drug|Oxaliplatin|chemotherapy drug
15836782|NCT04150640|Drug|5-FU|chemotherapy drug
15836783|NCT04150640|Drug|Trastuzumab|chemotherapy drug
15836784|NCT04150627|Other|deep breathing|Deep breathing maneuver to increase parasympathetic nerve activity
15836785|NCT04150614|Drug|Granisetron Transdermal Patch|Antiemetic
15836786|NCT04150614|Drug|Intravenous Dexamethasone|Antiemetic
15836787|NCT04150614|Drug|Ondansetron|ondansetron
15836788|NCT04150601|Device|SIMEOX|SIMEOX is a device generating a succession of gentle depression at the mouth.
15836789|NCT04150601|Device|PEP|A PEP device (Pari-PEP) will be used to provoke a positive expiratory pressure while exhaling, thereby stabilizing the airways during expiration.
15836790|NCT04150601|Other|Spontaneous Exhalation|A slow vital capacity maneuver will be performed according to the guidelines, from total lung capacity to residual volume
15836791|NCT04150588|Drug|Efrin drops|The amount that the eyelid rise after Erin drops before surgery
15836792|NCT04150575|Drug|HLX10+Albumin-Bound Paclitaxel|HLX10: 4.5 mg/kg/3w+Albumin-bound paclitaxel: 260 mg/m2/3w.Albumin-bound paclitaxel may be used for up to 6 cycles, and HLX10 for up to 2 years.
15836793|NCT04150562|Drug|rhIL-15|rhIL-15 will be administered by continuous intravenous infusion (CIV) at a starting dose of 2 mcg/kg/day for the first dose level followed by a second dose level of 4mcg/kg/day on days 1-5 of the 28-day cycle of each of four cycles.
15836794|NCT04150562|Biological|Avelumab|avelumab (800mg by IV) will be administered on days 8 and 22 of the 28- day cycle for four cycles
15836795|NCT04150549|Biological|Fecal Microbial Transplants|Healthy donor stool will be processed and placed into capsules.
15836796|NCT04150549|Biological|Fecal Microbial Transplants|Participants stool will be processed and placed into capsules.
15836797|NCT04150536|Drug|Lidocaine topical system 1.8%|
15836798|NCT04150523|Other|Survey|The study will involve a 22 question online survey, administered through the online survey platform conjoint.ly. Conjoint.ly is a web-based survey tool used to conduct survey research, evaluations and other data collection activities. Participants will complete a conjoint.ly survey and choose between treatment (antibiotic vs no antibiotic) scenarios.
15836799|NCT04150497|Biological|UCART22|Allogeneic engineered T-cells expressing anti-CD22 Chimeric Antigen Receptor given following a lymphodepleting regimen
15836800|NCT04150484|Other|Mediterranean diet, physical exercise and mindfulness workshops|a group of dietary intervention, physical exercise and mindfulness and another control group, and a longitudinal follow-up was carried out for 6 months from the beginning of the intervention.
15836801|NCT04150471|Other|RQ-PCR(Real-time Quantitative Polymerase chain reaction) RNA Analysis|Conventional Q-RT-PCR every 3 months
15836802|NCT04150458|Drug|18F-fluorocholine PET/CT.|18F-fluorocholine positron emission tomography / computed tomography
15836803|NCT04150445|Behavioral|Internet treatment for overweight and obese patients|The behavioral treatment is provided via the Internet and comprises 12 modules that the patient follows for 6 months. The treatment modules include self-monitoring, goal setting, relapse prevention, psycho-education about nutrition, eating behavior, physical activity, sleep and stress management. Each module ends with one or more exercises to be completed before the next module is activated.
15836804|NCT04150432|Device|Edmon|New device for exhaled propofol concentration measurements
15836808|NCT04150406|Dietary Supplement|Flexofytol|Curcuma extract
15836809|NCT04150406|Other|Placebo|placebo
15836810|NCT04150393|Drug|MaaT033 capsule|Oral capsule
15836813|NCT04150367|Drug|Isoniazid|Solution for injections, 100 mg/ml, 5 ml. Participants will get the dosage according to the instruction for use.
15836814|NCT04150367|Drug|Rifampicin|Participants will get the dosage according to the instruction for use.
15836815|NCT04150367|Drug|Ethambutol|Participants will get the dosage according to the instruction for use.
15836816|NCT04150367|Drug|Rifampicin|Participants will get the dosage according to the instruction for use.
15836817|NCT04150367|Drug|Isoniazid|. Participants will get the dosage according to the instruction for use.
15836818|NCT04150367|Drug|Ethambutol|Participants will get the dosage according to the instruction for use.
15836819|NCT04150354|Behavioral|Cogito Companion|During the course of the study, the research application (Cogito Companion) will be installed on participants' mobile phone. The application on the participants' phone will be recording data about their behavior. Participants will also be asked to complete bi-weekly surveys via the app.
15836820|NCT04150341|Drug|TD-8236|The study drug will be administered by inhalation in the morning for 14 days during each period. A washout period of at least 21 days will exist between subsequent periods.
15836821|NCT04150341|Drug|Placebo|The placebo will be administered by inhalation in the morning for 14 days during each period. A washout period of at least 21 days will exist between subsequent periods.
15836822|NCT04150315|Diagnostic Test|Proteome analysis|Evaluation of specific protein levels in tissue and plasma.
15836823|NCT04150302|Other|Exploratory interviews|Exploratory interviews to generate an interview guide
15836824|NCT04150302|Other|Semi-directive interviews|Semi-directive interviews to collect qualitative data that will be used for questionnaire item generation
15836825|NCT04150302|Other|Delphi Process|Cotation of newly developed items pertinence on a 4 points likert scale.
15836826|NCT04150302|Other|Think aloud interviews|Debriefing session for the newly developed items: final possibility to adjust the tool before validating the psychometric proprieties of the questionnaire.
15836827|NCT04150302|Other|Psychometric validation|Psychometric properties study
15836829|NCT04150276|Procedure|ZEEP during awakening|ZEEP will be established 2 min prior to the start of emergence preoxygenation and awakening.
15836830|NCT04150276|Procedure|PEEP during awakening|PEEP will be maintained throughout emergence preoxygenation and awakening.
15836831|NCT04150263|Procedure|Intraocular lens (IOL) ab externo scleral suture fixation|traditional IOL scleral suture fixation
15836832|NCT04150263|Procedure|Modified IOL ab externo scleral suture fixation|Modified IOL scleral suture fixation
15836833|NCT04150250|Drug|iOWH032|Anti-secretory synthetically manufactured small molecule designed to inhibit the cystic fibrosis transmembrane conductance regulator chloride channel.
15836834|NCT04150250|Drug|Placebo|Oral tablets matching iOWH032 on taste, appearance, dissolution time with the same excipients but no active ingredients.
15836835|NCT04150250|Other|V. cholerae Challenge|Freshly-harvested, wild-type Vibrio (V.) cholerae El Tor Inaba strain N16961,10^6 cfu suspended in 30 mL of sodium bicarbonate solution ingested orally.
15836836|NCT04150250|Drug|Antibiotics|"Antibiotic therapy may include:
~Ciprofloxacin 500 mg, twice daily;
~Azithromycin 500 mg, once daily (for those persons who are allergic to fluoroquinolones);
~Doxycycline 300 mg, once daily (for those persons who are allergic to fluoroquinolones)"
15836837|NCT04150237|Other|Simulation training in gastroscopy|Simulation-based training with virtual reality simulation at a Simbionix GI-mentor II endoscopy simulator and procedure training on a phantom.
15836838|NCT04150224|Drug|PBTZ169 640 mg OD|Two administrations once a day with a wash-out period: food effect
15836839|NCT04150224|Drug|PBTZ169 640 mg BiD|Twice a day fasted; 1 day of administration
15836840|NCT04150224|Drug|PBTZ169 960 mg SD|Once a day fasted
15836841|NCT04150224|Drug|PBTZ169 1280 mg SD|Once a day fasted
15836842|NCT04150224|Drug|PBTZ169 1280 mg MD|Once a day after meal, 14 doses
15836843|NCT04150211|Dietary Supplement|Polyherbal Exten(d) vs Placebo|Supplementation during 4 weeks
15836844|NCT04150198|Device|TEP/IRM|All participants will have a PET / MRI examination including: i) a 30-minute PET scan, 80 minutes after intravenous injection of 240 MBq of 18F-AV1451 ± 10% ii) a ZTE sequence (for attenuation correction of PET images), a 3D T1 anatomical sequence, a diffusion MRI, a functional MRI at rest (total duration: 45 minutes). These acquisitions will be made during the same exam session on a hybrid PET / MRI camera allowing simultaneous acquisitions. This visit lasts about 3 hours.
15836845|NCT04150185|Procedure|Donor hepatectomy|
15836846|NCT04150172|Drug|Rebamipide SR 150mg|Test drug
15836847|NCT04150172|Drug|Rebamipide IR 100mg|Reference Drug
15836848|NCT04150159|Dietary Supplement|FMD Arm|ProLon Fasting Mimicking Diet Plan
15836849|NCT04150146|Drug|Rebamipide SR 150mg after high-fat meal|Test Drug
15836850|NCT04150146|Drug|Rebamipide SR 150mg under fasting condition|Reference Drug
15836851|NCT04150133|Other|Low Residue Diet|Variable cohort will eat 3 low residue meals on the day prior to their planned colonoscopy
15836852|NCT04150120|Device|e-health device with application|In this project we focus on eHealth solutions for patients and/or their families in situations where they could benefit from enhanced communication options with specialist staff. In this design space we use a model where a 4G-enabled tablet computer is lent to the families for the length of the study, thus avoiding economic requirements on the families and keeping the equipment uniform. The tablets run an application that enables multiple forms of direct and bi-directional communication in real-time with specialist staff at the hospital. For the staff, the technical situation is different; here we have in earlier demonstrators used web-based solutions accessed with existing computer equipment.
15836853|NCT04150107|Drug|ORMD-0801|Oral Insulin Capsules
15836854|NCT04150094|Other|Pelvic floor muscle training (PFMT)|Participants will be firstly evaluated and orientated about pelvic floor muscles and pelvic floor muscle training. They will be clarified about the role of pelvic floor muscles in continence mechanisms and will be orientated to perform 8 weeks of PFMT without stimulus, coming once a week to a session supervised by physiotherapist and will be encouraged to perform the exercises at home during the other week days.
15836855|NCT04150094|Other|Pelvic floor muscle training + intravaginal vibratory stimulus|Participants will be firstly evaluated and orientated about pelvic floor muscles and pelvic floor muscle training. They will be clarified about the role of pelvic floor muscles in continence mechanisms and will be orientated to perform 8 weeks of PFMT with intravaginal vibratory stimulus. They will need to come once a week to a session supervised by physiotherapist to use the vibration device and will be encouraged to perform the exercises at home during the other week days.
15836856|NCT04150081|Procedure|Surgery or Endoscopic treatment|All the patients in the cohort will receive surgery o local (endoscopic) treatment, in some cases additional surgical treatment will be performed after an endoscopic primary treatment. This decision will have been taken based on daily clinical practice and does not represent a study intervention.
15836862|NCT04150055|Behavioral|Mindfulness Coach|Mindfulness Coach is an mHealth delivered mindfulness therapy.
15836863|NCT04150042|Drug|Melphalan|Intravenous melphalan (to be given in conjunction with the other listed drugs).
15836864|NCT04150042|Drug|BCNU|Intravenous BCNU (to be given in conjunction with the other listed drugs).
15836865|NCT04150042|Drug|Vitamin B12B|Intravenous vitamin B12b (to be given in conjunction with the other listed drugs).
15836866|NCT04150042|Drug|Vitamin C|Intravenous vitamin C (to be given in conjunction with the other listed drugs).
15836867|NCT04150042|Drug|Ethanol|Intravenous ethanol (to be given in conjunction with the other listed drugs).
15836868|NCT04150042|Device|Autologous Hematopoietic Stem Cells|After each cycle of chemotherapy, participants will receive an autologous hematopoietic stem cell infusion.
15836869|NCT04150029|Drug|MBG453|Solution for intravenous infusion
15836870|NCT04150029|Drug|Venetoclax|Tablet for oral administration
15836871|NCT04150029|Drug|Azacitidine|Solution for subcutaneous injection or intravenous infusion
15836872|NCT04150016|Procedure|percutaneous coronary intervention|Percutaneous coronary intervention (PCI), also known as coronary angioplasty, is a nonsurgical procedure that improves blood flow to your heart.PCI requires cardiac catheterization, which is the insertion of a catheter tube and injection of contrast dye, usually iodine-based, into your coronary arteries. Doctors use PCI to open coronary arteries that are narrowed or blocked by the buildup of atherosclerotic plaque. PCI may be used to relieve symptoms of coronary heart disease or to reduce heart damage during or after a heart attack.
15836873|NCT04150003|Behavioral|Pulmonary Rehabilitation program|Structured rehabilitation program of directed exercises
15836874|NCT04150003|Other|Usual care|Usual care for patients who had suffered a Pulmonary Embolism
15836875|NCT04149990|Drug|Valsartan+ sacubitril|Treatment with Entresto(valsartan+sacubitril)
15836876|NCT04149990|Drug|Placebo Oral Tablet|Matching placebo treatment
15836877|NCT04149977|Behavioral|Physical Therapy with pressure cuff|6 weeks of physical therapy will have similar exercises to standard therapy however the patients will use a cuff around the affected leg during the exercises.
15836878|NCT04149977|Behavioral|Physical Therapy with placebo pressure cuff|6 weeks of physical therapy will have similar exercises to standard therapy however the patients will use a pressure cuff around the affected leg during the exercises. The pressure cuff will have 50% of the pressure that will be considered effective.
15836879|NCT04149964|Drug|Acetaminophen 325 mg Oral Tablet|Standard of Care Acetaminophen 325 mg every 6 hours as needed for pain
15836880|NCT04149964|Drug|Acetaminophen 650 mg Oral Tablet|Acetaminophen 650 mg scheduled every 6 hours round the clock for pain
15836881|NCT04149964|Drug|OxyCODONE 5 mg Oral Tablet|Oxycodone 5 mg every 4 hours as needed for breakthrough pain
15836882|NCT04149964|Drug|Acetaminophen/Hydrocodone 325 mg/7.5 mg oral tablet|Acetaminophen 325 mg/ Hydrocodone 7.5 mg oral tablet every 4 hours as needed for breakthrough pain
15836883|NCT04149951|Device|Vestal Device|Vestibular nerve stimulator
15836884|NCT04149951|Device|Placebo device|Sham nerve stimulator
15836885|NCT04149938|Drug|Lidocaine topical system 1.8%|
15836886|NCT04149938|Drug|Lidocaine patch 5%|
15836887|NCT04149925|Device|AEON Endostapler|Surgery with AEON Endostapler
15836888|NCT04149925|Device|Echelon Flex Powered Stapler|Surgery with Echelon Flex Powered Stapler
15836889|NCT04149912|Diagnostic Test|Online questionnaire|Online questionnaire via SoSciSurvey
15836890|NCT04149899|Drug|Study Treatment 1 WB007|Dosed for 14 days in both eyes
15836891|NCT04149899|Drug|Study Treatment 2 WB007|Dosed for 14 days in both eyes
15836892|NCT04149899|Drug|Study Treatment 3 WB007|Dosed for 14 days in both eyes
15836893|NCT04149899|Drug|Timolol 0.5%|Dosed for 14 days in both eyes
15836894|NCT04149886|Procedure|cardiac ganglion plexus ablation(cardioneuroablation)|Cardiac ganglion plexus ablation in the left atrium will be performed before implanting permanent pacemaker in patients with sick sinus syndrome.
15836895|NCT04149886|Device|Permanent pacemaker implantation|DDD permanent pacemaker will be implanted in the paticipants.
15836896|NCT04149873|Procedure|MIE|MIE
15836897|NCT04149860|Drug|Lu AF87908|Lu AF87908 concentrate for solution for infusion IV, single dose
15836898|NCT04149860|Drug|Placebo|concentrate for solution for infusion IV
15836899|NCT04149847|Procedure|inguinal hernia repair|patients 18 years and above presenting with primary inguinal hernia
15836900|NCT04149834|Procedure|Group A (Test): Patients will receive NIPSA|patients received Non- incised papilla surgical approache
15836901|NCT04149834|Procedure|Group B (Control): Patients will receive M-MIST|patients received Modified Minimally Invasive Surgical Technique
15836902|NCT04149821|Drug|Umbralisib|"Lead-in cycle of 28 days (Cycle -1) of umbralisib monotherapy, 800mg oral daily
~Continued 800mg oral daily dosing in all subsequent cycles (combination therapy cycles 1-6, then continued monotherapy cycle 7 and beyond)"
15836903|NCT04149821|Drug|Ublituximab|-Co-administered on days 1 and 2 (dose split over days 1 and 2), 8, 15 of cycle 1 then on day 1 for subsequent cycles 2-6
15836904|NCT04149808|Device|Mepilex Ag (burn dressing)|Dressing for low to medium exuding burns and wounds.
15836905|NCT04149808|Device|Xeroform Dressing|Standard of care dressing for low to medium exuding burns and wounds.
15836906|NCT04149795|Diagnostic Test|Online questionnaire|Online questionnaire via SoSciSurvey
15836907|NCT04149782|Other|Routine medical record data collection|The study will collect routine medical record data from the electronic medical record system, other electronic databases, and paper charts.
15836908|NCT04149769|Device|Indego Exoskeleton|Regular dosing of Indego Exoskeleton walking.
15836909|NCT04149756|Other|observation of weight after 6months|"This study is an observational study for 96 people who have completed the previous weight loss program.
~We will check the body composition and lipid profile of the participants who voluntarily visit after 6months after the end of the study. ."
15836910|NCT04149743|Diagnostic Test|Standard of Care with Hemotag|Comparison of outcomes
15836911|NCT04149717|Dietary Supplement|Energy Drink Ingredients and Exercise|"Subject will ingest 500 mL of one of three test solutions:
~A) sucrose (150g) B) sucrose (150g); caffeine (400 mg) C) sucrose (150g); caffeine (400 mg); taurine (4,000 mg); carnitine (400 mg) 3. 30 min later, subject will exercise on a treadmill using the Bruce Protocol maximum exercise test (https://www.aopa.org/go-fly/medical-resources/health-conditions/heart-and-circulatory-system/bru...). For one additional session, subjects will receive test solution C without exercise.
~4. Each stage will last 3 minutes. Stage 1 = 1.7 mph at 2% Grade Stage 2 = 2.5 mph at 4% Grade Stage 3 = 3.4 mph at 6% Grade Stage 4 = 4.2 mph at 8% Grade Stage 5 = 5.0 mph at 10% Grade Stage 6 = 5.5 mph at 12% Grade Stage 7 = 6.0 mph at 14% Grade Stage 8 = 6.5 mph at 15% Grade Stage 9 = 7.0 mph at 15% Grade. The test will end when subjects reach exhaustion.
~5. 1, 2, and 4 hrs following ingestion, HR, BP, and EKG will be recorded."
15836912|NCT04149704|Behavioral|ACP video decision aid|10 minute video decision aid describing the goals-of-care options
15836913|NCT04149704|Other|Usual Care-|Verbal description of the three types of care
15836914|NCT04149691|Drug|CPL304110|CPL304110 is to be administered orally as hard gelatine capsules once daily in 28-day cycles.
15836915|NCT04149678|Drug|Ozanimod|Ozanimod
15836916|NCT04149678|Drug|Cyclosporine|Cyclosporine
15836917|NCT04149665|Device|simple blind observation|Device that measures continuously the angle of bed by mechanical Ventilation to assess the time the bed is above 35°.
15836918|NCT04149652|Diagnostic Test|Lung Elastosonography|Bedside lung ultrasound integrated with lung elastosonography, performed by using the convex probe of an Esaote Mylab Seven ultrasound system (Esaote, Genova, Italy), equipped with the strain elastography module ElaXto©.
15836919|NCT04149639|Dietary Supplement|NeuroQ|Supplement includes phosphatidylserine, coffee fruit, curcumin, ginkgo, gotu kola, and propolis active ingredients inside a veggie capsule.
15836920|NCT04149626|Drug|Dexmedetomidine|Sedation using dexmedetomidine (initial bolus dose followed by continuous infusion)
15836921|NCT04149626|Drug|Midazolam|Sedation using midazolam (initial bolus dose followed by continuous infusion)
15836922|NCT04149626|Drug|Remifentanil|Sedation using remifentanil (initial bolus dose followed by continuous infusion)
15836923|NCT04149600|Procedure|Patients scheduled to undergo aortic valve replacement or aortic surgery at BIDMC will be approached for participation in this study.|Adult patients undergoing aortic valve replacement (AVR) and/or aortic resection will be enrolled.
15836925|NCT04149574|Drug|nivolumab|Specified Dose on Specific Days
15836926|NCT04149574|Other|Placebo|Specified Dose on Specific Days
15836927|NCT04149574|Biological|Bacillus Calmette-Guérin (BCG)|Intravesicular
15836928|NCT04149561|Other|communication skill measurement with self report questionnaire|Demographic information form, Communication Function Classification System, Functional Communication Classification System, The Gross Motor Function Classification System and Manual Ability Classification System will be filled in for the patients.
15836929|NCT04149548|Diagnostic Test|ultrasound|Obstetric ultrasound to pregnant women
15836930|NCT04149535|Device|Sentinel® Cerebral Protection System|cerebral embolic protection system
15836931|NCT04149522|Device|Mepitel Film®|As a part of this research study, Mepitel Film® will be placed prior to a participant's first radiation treatment, and will be removed one week following the end of treatment. The Film will be placed by the physician or his/her designee to cover approximately one-half of the breast divided in the cephalo-caudal plane. The film will remain in place until one week following the completion of radiotherapy. Any loss of film applied will be replaced as needed. Application of the Film is done by research personnel clinically trained in its application procedures.
15836932|NCT04149496|Combination Product|in vitro maturation of oocytes|Immature oocytes (rather than mature oocytes) are harvested as in IVF. These oocytes are allowed to mature in the laboratory before fertilization
15836933|NCT04149483|Drug|Atorvastatin|One with the intervention (atorvastatin, 20mg OD), 30 patients for this arm.
15836934|NCT04149483|Drug|Placebos|One with the intervention (Placebo, 20mg OD), 30 patients for this arm.
15836935|NCT04149470|Drug|Omeprazole 20mg BID|High dose PPI therapy (Omeprazole 20mg twice daily)
15836936|NCT04149457|Other|Computerized Plasticity-Based Adaptive Cognitive Training|Thirty minutes of training on computerized exercises that targets visual processing speed, memory, attention and alertness.
15836937|NCT04149457|Other|Commercially available computerized training|Thirty minutes of training on computerized, casual video games.
15836938|NCT04149444|Drug|Trifluridine/Tipiracil|Oral medication
15836939|NCT04149431|Drug|Derinat|desoxyribonucleate sodium
15836940|NCT04149418|Other|Yogurt|Low-fat flavored yogurt
15836941|NCT04149418|Other|Control food|Low-fat flavored soy pudding
15836942|NCT04149405|Procedure|Phase 1 periodontal therapy|Scaling and root planning with ultrasonic and hand instruments under local anesthesia.
15836943|NCT04149405|Drug|Bisphosphonate therapy|Using aclasta: intravenous infusion of 5 mg of zoledronic acid once a year
15836944|NCT04149392|Device|Continuous Glucose Monitor|Patients with diabetes hospitalized for heart failure or acute myocardial infarction will have a continuous glucose monitor (CGM) placed on the day of discharge. The participants will go home with the device and keep it for 6-14 days until they return to clinic for follow up visit. At this time the device will be removed, the information regarding glucose levels during those days will be downloaded and based on the download, a PharmD will have the option of increasing or decreasing insulin doses by a maximum of 10% to reduce hypoglycemia and/or hyperglycemia. The goal will be to adjust medications, if needed, to target blood sugars between 90-250mg/dl greater than 80% of the time.
15836945|NCT04149379|Drug|Hyperbaric oxygen|20 sessions of hyperbaric therapy in a pressure chamber at 2,4 absolute atmospheres, 90 minutes per day of breathing 100% medical oxygen through an own mask. Table 14/90.
15836946|NCT04149366|Device|Retainer|Orthodontic retainer
15836947|NCT04149353|Diagnostic Test|PET/MR|Patient will be scheduled for a pre-treatment PET/MR and proceed to neoadjuvant chemotherapy per the direction of the medical oncologist. Within four weeks after completion of chemotherapy the patient will undergo a post-treatment PET/MR, and proceed for curative intent surgery if they are still surgical candidates.
15836948|NCT04149340|Drug|Cataract surgery|Patient's satisfaction and surgeon's satisfaction was assessed by four Lickert's scales, ranging from one to four. hemodynamic parameters before incision, 10 min post-incision and at the end of the surgery
15836949|NCT04149327|Drug|amoxicillin 500 mg + metronidazole 500 mg|500 mg amoxicillin and 500 mg metronidazole to be taken every 8 hours for 7 days
15836950|NCT04149327|Procedure|non-surgical periodontal and peri-implant treatment|"Patients are instructed on how to perform proper oral hygiene measures using an electric toothbrush, interdental brushes (to be used in combination with Corsodyl® gel) and floss (Oral-B® superfloss or Meridol® floss, at implants only).
~Patients will receive full-mouth mechanical cleansing of both implants and remaining dentition using ultrasonic instruments (EMS®) and hand instruments (scalers and curettes) in one or multiple sessions (max. 4). Prior to each session patients will rinse their mouth using 0.12% chlorhexidine + 0.05% cetylpyridinium chloride without alcohol during 30 seconds. At the final session all previously cleaned areas will be re-examined and cleaned."
15836951|NCT04149314|Other|HPI based hemodynamic optimization algorithm|Interventional patients will be treated by a HPI-based hemodynamic optimization protocol including HPI, Stroke volume, cardiac index and mean arterial pressure.
15836952|NCT04149301|Diagnostic Test|3D gait analysis|Children will have their walking measured in the gait laboratory to record their kinematics and kinetics along with electromyography (EMG) from key muscle groups.
15836953|NCT04149301|Diagnostic Test|MRI scan|The children will have two MRI scans taken - one with the foot loaded and one with no load applied.
15836954|NCT04149288|Dietary Supplement|High-polyphenol olive oil|High-polyphenol olive oil will be provided to study participants to consume at home. Participants will be asked to consume 40 mL each day for 2 weeks.
15836955|NCT04149288|Dietary Supplement|Low-polyphenol olive oil|Low-polyphenol olive oil will be provided to study participants to consume at home. Participants will be asked to consume 40 mL each day for 2 weeks.
15836956|NCT04149275|Drug|Cabozantinib|Treatment with oral Cabozantinib once daily
15836957|NCT04149275|Drug|Ipilimumab|IV administration of Ipilimumab on 21 day cycles
15836958|NCT04149275|Drug|Nivolumab|IV administration of Nivolumab on 21 day cycles, followed by Nivolumab maintenance on 28 day cycles
15836959|NCT04149262|Drug|Fiasp|Fiasp® used in a MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter
15836960|NCT04149262|Drug|Novorapid|Novorapid® used in a MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link transmitter
15836961|NCT04149262|Device|640G pump|MiniMed 640G system equipped with SmartGuardTM technology and accompanied with EnliteTM Sensor and GuardianTM 2 Link
15836962|NCT04149249|Other|Computer-Assisted Intervention Video Doctor|Complete CONNECT: participants will undergo in-person assessment questions and follow-up assessment questions. They will view and participate in the interactive Video Doctor about Smoking Cessation.
15836963|NCT04149249|Other|Computer-Assisted Intervention no Video Doctor|Individuals who are randomized to the control group will undergo the same assessment questions and all follow up assessments like the intervention group. Instead of viewing and participating in the interactive Video Doctor about Smoking Cessation, they receive a handout containing smoking cessation resources.
15836964|NCT04149223|Other|Evidence-based standardized Cirrhosis order set|Standardized order sets for guidance in ascites, varices, hepatic encephalopathy, infections, and medication reconciliation (optimizing HE medication, medication prophylaxis, withdrawal of non-indicated proton pump inhibitors).
15836965|NCT04149210|Drug|Fluorometholone 0.1% Oph Susp|fluorometholone 0.1% one drop twice daily for four weeks, beginning with one drop just before trachomatous trichiasis surgery on the upper lid.
15836966|NCT04149210|Drug|Artificial Tears|Artificial tears (placebo) given one drop twice daily for four weeks, beginning with one drop just prior to trachomatous trichiasis surgery on the upper lid.
15836967|NCT04149171|Drug|with red blood cells (RBC), Tranexamic acid (TXA) and Fibrinogen Concentrate (FC),administration of Crystalloids and TXA.|The treating physician must have evaluated the patient's eligibility and approved the patient's enrolment in the trial prior to blood samples extraction and RBC, TXA and Fibrinogen Concentrate administration. The experimental and control arms will be determined according to the medical emergency system units with RBC, TXA and Fibrinogen Concentrate administration capacity which will be the H2 helicopter unit ,fast intervention vehicle and G409 ambulance (Advanced Life Support). The medical emergency system units are activated according current protocols based on distance, severity and weather conditions.
15836968|NCT04149171|Drug|conventional treatment|standard treatment based on crystalloid fluid and tranexamic acid (TXA)
15836969|NCT04149158|Dietary Supplement|Placebo|
15836970|NCT04149158|Dietary Supplement|Sinetrol® Xpur|
15836971|NCT04149145|Drug|M4344+Niraparib|The first phase will be a 3+3 design of fixed dose Niraparib by mouth (PO) every day (QD) and M4344 will be escalated from 100-200 mg PO QD (28-day cycle). There will be a 4-week lead in with niraparib only.
15836972|NCT04149145|Drug|M4344+Niraparib|In the second phase eligible patients will receive combination Niraparib + the determined dose of M4344 from the first phase.
15836973|NCT04149132|Device|pulse photoplethysmography (PPG)|PPG and systolic blood pressure recording will be performed every two hours for three consecutive days. PPG reading will last two minutes and peaks of NO productions will be captured. Day 1 is considered the day of signing the informed consent followed by the first recording. On the first PPG recording of the same days i.e. on days 1, 2 and 3 the investigators will collect blood from the patients
15836974|NCT04149132|Diagnostic Test|Measurements of nitric oxide (NO) and malondialdehyde (MDA)|On the first PPG recording of the same days i.e. on days 1, 2 and 3 the investigators will collect blood from the patients. NO will be measured in serum samples by the Griess reaction. MDA that is considered an index of oxidant status will be measured in serum samples by the thiobarbiturate assay and analysis by high-performance liquid chromatography (HPLC)
15836975|NCT04149119|Device|Attractive Target Sugar Baits (ATSB)|Within the intervention area, a total of four ATSB station will be deployed (external wall). ATSB stations will be monitored by community health workers through weekly visit and all stations will be replaced 6months after deployment.
15836976|NCT04149106|Drug|Sulfadoxine pyrimethamine + Amodiaquin|Monthly dose of SPAQ over three days for SMC
15836977|NCT04149106|Drug|Dihydroartemisinin piperaquin|Monthly dose of DHAPQ for SMC
15836978|NCT04149093|Diagnostic Test|Calretinin staining|"A paraffin-embedded hematoxylinphloxin-safran sections will be performed on tissue specimens of proximal resection margins to evaluate the presence or absence of ganglion cells.
~Immunohistochemistry (IHC) will then be done on paraffin-embedded sections for calretinin staining."
15836979|NCT04149080|Procedure|SIM + polypropylene membrane|After tooth extraction the socket will be filled with 1.2% simvastatin gel and covered with polypropylene membrane, which will be intentionally exposed.
15836980|NCT04149080|Procedure|Placebo|After tooth extraction the socket will be filled with gel and covered with polypropylene membrane, which will be intentionally exposed.
15836981|NCT04149067|Drug|Dapagliflozin|Evaluation of the effectiveness and safety of the Dapagliflozin treatment.
15836982|NCT04149067|Drug|Sitagliptin|Evaluation of the effectiveness and safety of the Sitagliptin treatment.
15836983|NCT04149054|Behavioral|"Mobile health app called Hola Bebe"|For the pilot, all participants received a mobile app that contained 6 interactive audio/written modules in Spanish and English on the following topics: healthy eating; physical activity; portion control; eating healthy while eating out; eating out in Chinese, Italian, Mexican restaurants; and eating out in fast food restaurants. As noted above, the mobile app was customizable to include personalized activity reminders/notifications, and tailored action plans, along with videos for easy at-home exercises and user-friendly, easy-to-follow recipes.
15836984|NCT04149041|Diagnostic Test|ultrasound|POCUS is applied to adult patients in an emergency department.
15836985|NCT04149028|Procedure|PRP injection inside the ovary by laparoscoy. The injection volume is 2 ml|intraovarian injection of 2 mml of PRP by laparoscopic guide
15836986|NCT04149015|Drug|paclitaxel ,oxaliplatin,fluorouracil|A 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and leucovorin (400 mg/m2), administered simultaneously over a 2-hour infusion period. Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating every 14 days for 4 cycles.
15836987|NCT04149002|Behavioral|Intervention Arm Weekly IP3 text messages|Subjects will be provided with a pre and post intervention survey, in addition to a narrated Powerpoint presentation focusing on the logistics of their IP3. Subjects will also receive weekly automated text messages to encourage adherence to the need for their IP3.
15836988|NCT04149002|Other|Active Control Arm General pregnancy text messages|Subjects will be given pre and post pre questionnaires, in addition to a narrated Powerpoint presentation about the Clinic. Subjects will also be sent weekly text messages with general pregnancy information.
15836989|NCT04148989|Other|Code Sepsis protocol (full implementation)|Implementation of a coordinated, structured, multidisciplinary team-based protocol for initial evaluation and treatment of ED patients with suspected sepsis.
15836990|NCT04148976|Dietary Supplement|Placebo|A mixture of maltodextrins and calcium caseinate divided into 30g individual packets.
15836991|NCT04148976|Dietary Supplement|Dietary portfolio|A mixture of functional foods divided into 30g individual packets.
15836992|NCT04148963|Drug|Inhaled loxapine|Inhaled Loxapine 9.1 mg, may repeat x 1 or 2 after 2 hours
15836993|NCT04148963|Drug|Inhaled placebo|Inhaled placebo, may repeat x 1 or 2 after 2 hours
15836994|NCT04148950|Other|Kinesio Tape|
15836995|NCT04148950|Other|Compression Stockings|
15836996|NCT04148950|Other|Exercise Program|
15836997|NCT04148937|Drug|LY3475070|Administered orally
15836998|NCT04148937|Drug|Pembrolizumab|Administered IV
15836999|NCT04148924|Other|Questionnaire|"Patients complete a questionnaire for assess their symptoms like anxiety and depression.
~These questionnaires contains:
~socio-demographic characteristics : sex, age, type and stage of cancer, performans status
~ESAS : Edmonton Symptom Assessement Scale is a validated tool for assessment of several symptoms
~HADS - A : Hospital Anxiety and Depression scale includes 2 subscales which assess anxiety (HADS-A) and depression (HADS-D)
~BEDS : Brief Edimburg depression Scale is s a relevant scale for assess depression in palliative care patients.
~Questions on the assessment, the treatment and difficulties in management of anxious and depressive symptoms.
~The evaluation will be realized in the first days of hospitalization (72 hours)."
15837000|NCT04148924|Other|Medical staff questionnaire|"Questionnaire is different from caregivers. The evaluation will be realized in the first days of hospitalization (72 hours).
~Physicians, nurses and caregivers complete another questionnaire. The physician questioned will be the doctor of unit having received the patient, or the doctor of the mobile team of palliative care having admitted the patient in the unit.
~These questionnaires contains:
~socio-demographic characteristics : sex, age, type and stage of cancer, performans status
~ESAS : Edmonton Symptom Assessement Scale is a validated tool for assessment of several symptoms"
15837003|NCT04148898|Drug|Osimertinib|Treatment of LM With osimertinb
15837004|NCT04148898|Drug|Bevacizumab|Treatment of LM With osimertinb combined with bevacizumab
15837005|NCT04148885|Drug|nab-paclitaxel|Patients firstly receive nab-paclitaxel 100 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.
15837006|NCT04148885|Drug|carboplatin|Patients secondly receive carboplatin AUC=5 (iv, 30 minutes) on days 1 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.
15837007|NCT04148872|Other|Neuromuscular Retraining Therapy (4 months)|Neuromuscular retraining is an intervention where facial therapists utilize voluntary input to access improved movement patterns in patients with synkinesis.
15837008|NCT04148872|Drug|Chemodenervation (4 months)|A neurotoxin that temporarily reduces muscle activity and minimizes the effects of uncoordinated muscle.
15837009|NCT04148872|Other|Neuromuscular Retraining + Chemodenervation|Participants will receive both interventions for the last 4 months of their time on study.
15837010|NCT04148859|Procedure|amnioreduction|The amniotic fluid is drained via needle, which is stubbed in the abdomen wall, connected to a tube into a plastic bag. The amniotic fluid pressure will be measured by a water manometer. A T-shape connector will be connected to the tube on one side, and to a short tube on the other side. The height of the fluid within the short tube will indicate the pressure. All the fluid will be drained to the plastic bag. The pressure and the blood flow of the fetuses will be measured during the procedure, depends on the drainage rate.
15837011|NCT04148846|Drug|Dypirone|Dipyrone 2g, 6 / 6h for 7 days, orally or intravenous
15837012|NCT04148846|Procedure|Sphenopalatine block|The sphenopalatine block will be performed with the patient in the supine position, with neck extended. Following topical anesthesia of the nasal vestibules with one application of 10% lidocaine spray and one application of 2% lidocaine gel in each nostril, two long cotton swab applicators embedded in 2% lidocaine jelly, one in each nostril, will be introduced. They will be advanced at a 45-degree angle to the floor of the nose until resistance is encountered, indicating that the swab is in the posterior nasopharyngeal wall, superior to the middle nasal concha. It will be held in this position for 5 minutes and then removed. Thereafter, a 14 gauge, non-cutting, teflon blunt catheter will be introduced into each nostril at a 45 ° angle to the hard palate until it touches the posterior wall of the nasopharynx. For it will be applied 2ml of 0.375% Ropivacaine, on each side, slowly.
15837013|NCT04148846|Drug|Ketoprofen|Ketoprofen 100 mg, 12 / 12h for 5 days, orally or intravenous
15837014|NCT04148846|Drug|Gabapentin|Gabapentin 300 mg 8 / 8h for 7 days orally
15837015|NCT04148846|Drug|Dexamethasone|Dexamethasone 4mg 8 / 8h for 48h orally
15837016|NCT04148846|Drug|Theophylline|Theophylline 200mg, 12 / 12h, for 5 days, orally
15837017|NCT04148846|Dietary Supplement|Espresso coffee|Espresso coffee 20ml, 5x / day, for 7 days
15837018|NCT04148833|Drug|LDE-Paclitaxel|LDE-Paclitaxel at the dose of 175 mg/m2 IV each 21 days for 6 weeks
15837019|NCT04148833|Drug|LDE-Placebo|LDE-Placebo at the dose of 175 mg/m2 IV each 21 days for 6 weeks
15837020|NCT04148820|Drug|Aspirin, Atorvastatin, Perindopril|Cardiovascular drugs will be administered all together every day at the same time
15837021|NCT04148807|Behavioral|Progressive Walking with Gait Retraining|A progressive walking program with gait retraining will be performed on a treadmill at self-selected comfortable walking speed wearing an inertial measurement unit (IMU) on the medial aspect of the distal tibia. The (vertical) peak positive acceleration (PPA) of the tibia is a measure of tibial shock. Subjects will be provided real-time audio feedback to reduce PPA by 20% of their average peak PPA. During retraining sessions, a faded feedback approach will be used. Feedback will be provided continuously during the first four sessions and will be faded over the last 4 sessions. Walking time will increase over the 8 sessions.
15837022|NCT04148807|Behavioral|Progressive Walking Program|A progressive walking program will also be performed on a treadmill where subjects will walk at a self-selected comfortable speed with the same walking times per session as the retraining group without any feedback or retraining cues.
15837023|NCT04148794|Behavioral|echo-assisted advanced life support|"Integrated point-of-care ultrasound skill in to the setting of resuscitation, and critical condition patients.
~Educate the participants to use these protocols and monitoring if there were improvement of patient's outcomes"
15837024|NCT04148781|Drug|Fampridine SR|Fampridine-SR 10 mg twice daily for 8 weeks
15837025|NCT04148768|Device|Inferential therapy|Interferential therapy(IFT) utilises two of these medium frequency currents, passed through the tissues simultaneously, where they are set up so that their paths cross & they literally interfere with each other - hence another term that has been used in the past but appears to be out of favour at the moment - Interference Current Therapy. This interaction gives rise to an interference current (or beat frequency) which has the characteristics of low-frequency stimulation.
15837026|NCT04148768|Device|short wave diathermy|SWD: Technical specification of Generator frequency: 27.12 MHz, ± 0.6% Output power: continuous High-Frequency max. 400 W, pulsed High-Frequency max. 1000 W (peak) Pulse duration: ca. 400 µs Pulse repetition frequency: 15-200 Hz adjustable in 10 steps Mains supply: 230-240 V / 50 Hz Mains voltage variation: approx. ± 10% Current consumption: approx. 6 Ampere (at 230 V)
15837027|NCT04148755|Procedure|Endoscopic ultrasound guided fine needle aspirate|All patients are going to have an EUS guided elastography with FNA of solid pancreatic lesions
15837028|NCT04148742|Drug|DZD9008|Daily dose of DZD9008, except for cycle 0 of Part A, in which a single dose of DZD9008 is administrated. Starting dose of DZD9008 is 50 mg once daily. If tolerated, subsequent cohorts will test increasing doses of DZD9008.
15837029|NCT04148729|Drug|ESP block|Ultrasound guided ESP block will perform with 15 ml bupivacaine+ 5 ml lidocaine at the T10 level bilaterally. 0.1 microgram morphine (IV) and diclofenac sodium 75 mg intramuscularly will perform for postoperative analgesia.
15837030|NCT04148729|Drug|Control Group|In this group Ultrasound guided ESP block will not perform. Postoperative analgesia will provide with 0.1 microgram morphine (IV) and diclofenac sodium 75 mg intramuscularly.
15837031|NCT04148716|Procedure|additional biopsies|additional biopsies during a fibroscopy planned in the care
15837032|NCT04148703|Other|Follow up post Pacemaker implantation in office|All patients will be implanted with a single or dual chamber pacemaker according the implantation guidelines and will be followed by in-office follow-up
15837033|NCT04148703|Other|Follow up post Pacemaker implantation by home monitoring|All patients will be implanted with a single or dual chamber pacemaker according the implantation guidelines and will be followed by home monitoring
15837034|NCT04148690|Other|Group antenatal care (GANC)|Group antenatal care (GANC) is a service delivery model where women with pregnancies of similar gestational age are brought together for antenatal care (ANC), incorporating information sharing and peer support.
15837035|NCT04148690|Other|Standard antenatal care|Routine antenatal care as recommended by th Ministry of Health of Tanzania
15837036|NCT04148677|Dietary Supplement|Protoves M1®|A combination of two alkaloid, Protopine and Nuciferine (Protoves-M1 ®)
15837037|NCT04148664|Procedure|Catheter ablation with Standard RF ablation settings|"Standard RF ablation settings (n=30):
~Maximum 35W for 20-40 seconds, per operator standard."
15837038|NCT04148664|Procedure|Catheter ablation with High Power Short Duration RF ablation settings|"High power short duration RF (n=30):
~Maximum 50 Watts for 5-15 seconds, per operator standard."
15837039|NCT04148651|Device|The CO2RE® System|The CO2RE® system is a fractional CO2 laser that is FDA-cleared under a 510(k) K181523 for laser incision, excision, ablation and/or vaporization and of soft tissue in gynecology (GYN) for the treatment of leukoplakia (vulvar dystrophies).
15837040|NCT04148612|Diagnostic Test|Opti-Me|Opti-Me algorithm provides the likelihood of response to the 3 treatment options: SSRIs, SNRIs or TMS in MDD patients.
15837041|NCT04148599|Drug|dexmedetomidine infusion|a loading dose of 1µg/kg of dexmedetomidine (precedex) made to 50 ml using normal saline will be given over 10 minutes followed by infusion of dexmedetomidine with a dose of 0.5µg/kg/hour till the end of surgery.
15837042|NCT04148599|Drug|lidocaine infusion|a loading dose of 1.5 mg/kg of lidocaine made to 50 ml using normal saline and given over 10 minutes followed by infusion of lidocaine with a dose of 1.5 mg/kg/hour till the end of surgery.
15837043|NCT04148599|Drug|Placebos|50 ml of normal saline given over 10 minutes followed by saline infusion intraoperatively at a rate of 10 ml/hour till the end of surgery.
15837044|NCT04148586|Other|Whole Breast Irradiation|Whole Breast Irradiation after CBS in females with DCIS and early stage breast cancer
15837045|NCT04148573|Drug|NFX88 - 1|3 times a day
15837046|NCT04148573|Drug|NFX88 - 2|3 times a day
15837047|NCT04148573|Drug|NFX88 - 3|3 times a day
15837048|NCT04148573|Drug|PLACEBO - 4|3 times a day
15837049|NCT04148560|Other|Tests of the validity of the RFPM and SmartIntake app.|Participants who enroll will be trained in using the RFPM/SmartIntake app and a food record and will complete the Food Intake Assessment Preference Survey. They will also use both methods to estimate intake during a simulated lab-based meal (they will not eat during this simulated meal). They will be dosed with DLW at this visit and will use the RFPM for the subsequent 1-2 days to get accustomed to using the method, with the following three days comprising the data collection period.
15837050|NCT04148547|Device|Sooma transcranial direct current stimulation device|This group received brain training through transcranial direct current for 20 minutes.
15837051|NCT04148547|Device|Placebo Sooma transcranial direct current stimulation device|This group received sham brain training through transcranial direct current for 20 minutes. The current is active for 15 seconds and then switches off until the intervention is finished.
15837052|NCT04148534|Drug|Muscle Relaxants, Non Depolarizing|compare the operating condition of two different levels of muscle relaxation on facial nerve monitoring using transcranial motor evocked potential in CPA surgery
15837053|NCT04148521|Behavioral|Behavioral Health - Virtual Patient Navigation|Patients are identified by a clinician in the ED as needing psychiatric evaluation and a referral is made to a tele-psych provider for a virtual consult. Patients can be enrolled to the intervention arm based on a randomization scheme that randomly allocates days that navigators are available. The psychiatrist will make a recommendation to admit or discharge the patient. For patients that have a discharge recommendation on days that BH-VPN is available, patients will be offered the BH-VPN program. Enrolled patients are followed for up to 45 days. On days where the navigator is available, all patients who meet eligibility criteria will be considered exposed to the intervention.
15837054|NCT04148508|Behavioral|Tailored Emotional Competence Self-help|The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion. Interventions are personalised to the individual based on emotional competence skills. Intervention is in addition to self-monitoring in the app. Intervention components include selection of 2 from 4 of : targeting worry and rumination; increasing emotional knowledge and perception skills; improving achievement appraisals including attribution retraining and growth mindset; improving social appraisals including positive interpretations of ambiguous social events
15837055|NCT04148508|Behavioral|Cognitive-behavioural Approach|The active interventions are all entirely self-help and provide psycho-education, tips, advice and strategies for well-being promotion, based on cognitive-behavioural principles such as increased activity and challenging negative thinking. Interventions are generic and common to all participants. Intervention is in addition to self-monitoring in the app.
15837056|NCT04148508|Behavioral|Self-monitoring|Self-monitoring app that involves monitoring emotions and emotional events over time within the app and being able to review emotion over time
15837057|NCT04148495|Drug|placebo of acetaminophen IV|"Mophine IV: Initial loading dose of 0.1 mg/kg (ensuring that the maximum dose of 10 mg is not exceeded) followed by bolus of 0.05 mg/kg every 10 minutes (taking care not to exceed the maximum dose of 5 mg) as reported by the recommandation of experts of the french society of urgency care.
~Placebo of acetaminophen IV: Sodium chloride 0.9%"
15837058|NCT04148495|Drug|acetaminophen IV|"Mophine IV: Initial loading dose of 0.1 mg/kg (ensuring that the maximum dose of 10 mg is not exceeded) followed by bolus of 0.05 mg/kg every 10 minutes ((taking care not to exceed the maximum dose of 5 mg) as reported by the recommandation of experts of the french society of urgency care.
~Acetaminophen IV: 1 g"
15837059|NCT04148482|Other|Dietary intervention|To investigate whether individuals with divergent genetic susceptibility have different food preferences and have differential post-prandial glycemic and metabolomics responses to a standardized or an election meal.
15837060|NCT04148469|Procedure|Dry needling|Dry needlin is a manual therapy technique used for miofascuial pain syndrom treatment. The patient will be supine, in a confortable position. The therapist localizes the trapezius trigger point number 2 and then performes the needling until 2 REL are obtenined. The patient will remain supine during 15 minutes.
15837061|NCT04148469|Procedure|Transcutaneous Nerve Stimulation.|Transcutaneous Nerve Stimulation (TENS) is a current used for pain treatment. The needle will be used as the negative pole and a adhesive patch 2 centimeters lateral will be the positive pole. The frecuency selected will have 2 Hz with pulses of 120 microseconds. The currente will be applied for 15 minutes.
15837062|NCT04148469|Procedure|Placebo needling|No active technique is performed with the placebo needling. Patient will be supine and a placebo needle willb be performed. The patient will remain supine for 15 minutes.
15837063|NCT04148456|Procedure|Covered Endovacular Reconstruction of Aortic Bifurcation|"The occlusive lesion is then passed, either subintimal or endoluminal, using crossing wires and catheters.
~After gaining re-entry into the lumen of the aorta, angiography will be confirmed proper positioning for those with a subintimal passage.
~A 10-12 mm V12 LD balloon expandable ePTFE covered stent (Atrium Medical, Maquet Getinge Group, Hudson, NH) will be expanded in the distal aorta approximately 20 mm above the bifurcation through the 9 Fr sheath.
~The proximal 2/3 part of the aortic stent will be flared with a larger balloon, usually 16 mm, thereby creating a funnel shaped covered stent. Subsequently, two 8 mm V12 balloon expandable ePTFE covered stents (Atrium Medical, Maquet Getinge Group, Hudson, NH) will be placed proximally in the distal 1/3 of the aortic stent, and then simultaneously deployed distally into the common iliac arteries creating a tight connection with the first aortic stent, thereby creating the new aortic bifurcation."
15837064|NCT04148443|Other|Preoxygenation|participants will receive 3 minutes of preoxygenation before intubation
15837065|NCT04148443|Other|Preoxygenation (longer)|participants will receive 5 minutes of preoxygenation before intubation
15837066|NCT04148430|Drug|Anakinra|100mg subcutaneous
15837067|NCT04148417|Device|Solo+ Tympanostomy Tube Device|The Solo+ Tympanostomy Tube Device is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure
15837068|NCT04148404|Procedure|Normothermic group|"Normothermic group (NT group) included patients will undergo CABG under warm bypass using warm blood cardioplegia (Normothermic CBP).
~Hypothermic group (HT group) included patients will undergo CABG under cold bypass using cold blood cardioplegia (Hypothermic CBP)."
15837069|NCT04148391|Drug|Placebo Oral Capsule|Matching placebo capsules.
15837070|NCT04148391|Drug|NYX-458|NYX-458 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
15837071|NCT04148378|Other|No intervention|There is no intervention for this study.
15837072|NCT04148352|Drug|Dupilumab|Dupilumab injected every 2 weeks for 18 weeks
15837073|NCT04148352|Other|Placebo|Placebo injected every 2 weeks for 18 weeks
15837074|NCT04148339|Other|No Intervention|There is no intervention for this study.
15837075|NCT04148326|Other|No Intervention|There is no intervention for this study.
15837076|NCT04148313|Other|No Intervention|There is no intervention for this study.
15837218|NCT04147208|Drug|GLS4|Administered GLS4 120 mg orally three times daily in fed state
15837077|NCT04148287|Drug|APX001|Day 1: APX001 1000 mg IV BID over a 3-hour infusion Days 2-3: APX001 600 mg IV QD over a 3-hour infusion Days 4 - 42: APX001 600 mg IV QD over a 3-hour infusion or APX001 800 mg QD oral.
15837078|NCT04148274|Other|No intervention|There is no intervention for this study.
15837079|NCT04148261|Drug|Hydrocortisone Acetate (CORT)|Participants will receive a single dose of hydrocortisone at a dosage of 0.65 mg/kg
15837080|NCT04148261|Drug|Epinephrine Sulfate (EPI)|Participants will receive a continuous infusion of epinephrine at a dosage of 80 ng/kg/min
15837081|NCT04148261|Drug|Placebo (PLB)|Participants will receive a placebo
15837082|NCT04148248|Other|No intervention|There is no intervention for this study
15837083|NCT04148235|Other|No Intervention|There is no intervention for this study
15837084|NCT04148222|Other|No intervention|There is no intervention for this study
15837085|NCT04148209|Drug|PF-07081532|Participants will receive single ascending doses PF-07081532
15837086|NCT04148209|Drug|Placebo|Participants will receive placebo
15837087|NCT04148196|Other|Progressive muscle relaxation exercise|The CD on relaxation exercises developed by the Turkish Psy-chological Associationwas used.In the second of CD 27-min section; relaxation exercises are explained to the accompaniment ofrunning water sounds and verbal instructions. Progressive relaxation technique includes stretching and relaxing the bigmuscle groups (hands, arms, neck, shoulders, face, chest, abdomen,hip, feet andfingers) in the human body on purpose. When steps ofProgressive Relaxation Exercises are analyzed, it is observed thatlearning how to take correct and deep breaths is the most impor-tant step towards learning relaxation. In addition, taking correct breaths is used as a part of the exercise among all relaxation exercises.Steps of Progressive Relaxation Exercise:- breathing exercises- lower extremity exercises- upper extremity exercises- exercise of respiratory muscles. Elderly individuals will receive PMR exercise twice a week under the guidance of an investigator for eight weeks.
15837088|NCT04148183|Drug|Metformin group|We add treatment with Metformin (850 mg/day), treatment was administered for 8 weeks
15837089|NCT04148183|Drug|Rosiglitazone group|we add Rosiglitazone (4 mg/day), treatment was administered for 8 weeks
15837090|NCT04148183|Drug|Placebo oral tablet|We add Placebo, treatment was administered for 8 weeks
15837091|NCT04148170|Procedure|Endodiathermy Probe and Intubation Versus Intubation|children suffer from congenital nasolacrimal duct obstruction will have probing with endodiathermy probe and then intubation with bicanlicular silicon tube
15837092|NCT04148144|Other|No intervention included|No intervention included
15837093|NCT04148118|Biological|BW-1010: 50 µg - sprayer - IN|"20% Nanoemulsion and 50 µg recombinant protective antigen administered intranasally by Aptar Bidose Sprayer (400µL).
~Two doses administered 4 weeks apart."
15837094|NCT04148118|Biological|BW-1010: 50 µg - pipette - IN|"20% Nanoemulsion and 50 µg recombinant protective antigen administered intranasally by pipette (400µL).
~Two doses administered 4 weeks apart."
15837095|NCT04148118|Biological|BW-1010: 100 µg - sprayer - IN|"20% Nanoemulsion and 100 µg recombinant protective antigen administered intranasally by Aptar Bidose Sprayer (400µL)
~Two doses administered 4 weeks apart"
15837096|NCT04148118|Biological|BW-1010: 100 µg - pipette - IN|"20% Nanoemulsion and 100 µg recombinant protective antigen administered intranasally by pipette (400µL).
~Two doses administered 4 weeks apart."
15837097|NCT04148118|Biological|Saline (Placebo) - sprayer - IN|"Saline (negative control) administered intranasally by Aptar Bidose Sprayer (400µL).
~Two doses administered 4 weeks apart."
15837098|NCT04148118|Biological|Saline (Placebo) - pipette - IN|"Saline (negative control) administered intranasally by pipette (400µL).
~Two doses administered 4 weeks apart."
15837099|NCT04148118|Biological|BioThrax (positive control) - SC|"BioThrax licensed vaccine administered subcutaneously (500µL).
~Three doses administered 2 weeks apart."
15837100|NCT04148105|Drug|Cilostazol 100 MG|The addition of 100 mg cilostazol, twice daily for 14 days, to the standard treatment regimen of 60 mg nimodipine every 4 hours for 21 days and the standard aneurysmal subarachnoid treatment pathway
15837101|NCT04148105|Other|Placebo|The standard treatment regimen of 60 mg nimodipine every 4 hours for 21 days and the standard aneurysmal subarachnoid treatment pathway
15837102|NCT04148092|Drug|ripretinib|orally administered solid dosage form
15837103|NCT04148079|Other|physical therapy|low frequency currents (galvanic or TENS), medium frequency currents (interferential) and high frequency currents (short wave diathermy), all combined with an individualized exercise program and massage therapy
15837104|NCT04148066|Diagnostic Test|ctDNA blood sample|every six weeks during treatment and upon radiological progression blood will be drawn to analyse ctDNA with Avenio ctDNA (Expanded panel) to detect all known EGFR TKI resistance mechanisms.
15837105|NCT04148053|Diagnostic Test|TB-antigen responsive T cell markers|A blood test including a series of T cell markers which are responsive to TB antigens
15837106|NCT04148040|Procedure|G-POEM|Per-oral pyloromyotomy (POP), also named as gastric per-oral endoscopic myotomy (G-POEM), for treating infantile hypertrophic pyloric stenosis (IHPS) has the following steps: mucosal incision, creation of submucosal tunnel, full-thickness pyloromyotomy, closure of the mucosal entry.
15837107|NCT04148027|Other|Treatment recommendation by emergency department physicians|Standard treatment after admission in the emergency department from a team of residents in internal medicine, neurology and general surgery.
15837108|NCT04148027|Other|Treatment recommendation by telemedical geriatric co-evaluation|Treatment recommendation from a board-certified geriatrician linked for co-evaluation by means of video transmission
15837109|NCT04148014|Behavioral|An Adjunctive Emotion Regulation Skills Training|The adjunctive emotion regulation skills training is delivered in a group format once a week during 5 weeks to young adults with eating disorders together with treatment as usual
15837110|NCT04147988|Other|screening and diagnostic assessment DONALD T unit list|Screening and diagnostic assessment of the group of people awaiting assessment, and thus test the feasibility of a screening and diagnosis procedure for autism in adults without intellectual disabilities
15837111|NCT04147975|Diagnostic Test|RaPID/BSI Test|RaPID/BSI Test
15837112|NCT04147962|Device|intense pulsed light (usual practice)|collection data : parameters used for each treatment session: duration of treatment session and intensity of intense pulsed light
15837113|NCT04147949|Drug|AV-101|Oral capsules taken twice daily for 14 days
15837114|NCT04147949|Drug|Placebo|Oral capsules taken twice a day for 14 days
15837117|NCT04147923|Dietary Supplement|Floradapt Mature Immune Defense + Multivitamin|The product consists of two L. plantarum strains, KABP XXXX and KABP XXXX with a combined strength of >1 x 10^9 CFU. Participants will also consume a multivitamin.
15837118|NCT04147923|Dietary Supplement|Placebo + Multivitamin|No active ingredients + a multivitamin supplement
15837119|NCT04147910|Drug|KW-6356|Single oral dose of KW-6356
15837120|NCT04147897|Device|FOCUS|FOCUS is a self management mHealth application for people with serious mental illness.
15837122|NCT04147871|Drug|ADV7103|Each dose of ADV7103 contains a fixed ratio of 1/3 of ADV7103-CK (potassium citrate) and 2/3 of ADV7103-BK (potassium bicarbonate) based on the mass of active substances.
15837123|NCT04147871|Drug|Placebo|"Placebo is a combination of 2 mm green coated lactose granules and 2 mm white coated lactose granules.
~Each dose of placebo contains a fixed ratio of 1/3 of green granules and 2/3 of white granules."
15837124|NCT04147858|Drug|NYX-2925|NYX-2925 administered orally
15837125|NCT04147858|Drug|Placebo|Placebo administered orally
15837126|NCT04147845|Other|Fractional Carbon Dioxide Laser|"The ablative fractional CO2 laser is delivered to the patients' scalp. The fractional ablative method is applied immediately before the topcial medication.
~Laser treatment will be given to the affected area, and immediately after the treatment, the treatment solution will be dropped on the treated area and spread evenly"
15837127|NCT04147845|Other|Microneedling using dermapen|"Microneedling is performed using Dermapen. This creates pin point bleeding or mild erythema which will be considered as the end point.
~The treatment solution will be applied on each lesion twice, before and after performing microneedling."
15837128|NCT04147845|Other|Triamcinolone Acetonide|triamcinolone solution (10 mg/ml) will be dropped on the treated area and spread evenly
15837129|NCT04147845|Other|Platelet-rich plasma|The applied PRP will be spread over the whole affected area
15837131|NCT04147819|Drug|BAY2701439|Intravenous (IV) injection on Day 1 of each cycle.The duration of each cycle will be 6 weeks (42 days).
15837132|NCT04147819|Drug|BAY2701438|Intravenous (IV) injection on Day 1 of each cycle and 1 hour before the start of administration of BAY2701439. The duration of each cycle will be 6 weeks (42 days).
15837133|NCT04147806|Radiation|IGRT 45 Gy in 5 fractions of 9 Gy|Administration of 9 Gy in five consecutive days, to a total dose of 45 Gy radiation
15837134|NCT04147806|Radiation|IGRT 24 Gy single dose|Administration of a single dose of 24 Gy in one session
15837135|NCT04147806|Drug|Dexamethasone|4 mg by mouth on treatment days only
15837136|NCT04147806|Drug|Tamsulosin|0.4 mg by mouth daily starting the day of simulation and until 2 weeks post-treatment.
15837137|NCT04147780|Procedure|Sentinel node biopsy|Sentinel node biopsy, radiotracer (mandatory) and blye dye (optional). Scintigraphy.
15837138|NCT04147767|Dietary Supplement|Cholesterol Reducing Strawberry Yogurt Drink (Tesco Ltd)|"Ingredients: Skimmed Milk, Strawberry Juice from Concentrate (5%), Plant Sterols Ester (3.4%)***, Sugar, Maize Starch, Flavourings, Colour (Anthocyanins), Starter Culture including Bifidobacterium (Milk), Thickener (Carob Gum), Sweetener (Sucralose), Milk Proteins.
~*** Equivalent to 2% Free Plant Sterols"
15837139|NCT04147767|Dietary Supplement|Low Fat Strawberry Yogurt Drinks (Morrisons Ltd)|Ingredients: Yogurt (Milk), Water, Sugar, Strawberry Purée (1%), Modified Maize Starch, Carrot Concentrate, Flavouring, Acidity Regulator (Citric Acid), Vitamin C, Colour (Paprika Extract), Sweetener (Sucralose), Vitamin D, Vitamin B6.
15837140|NCT04147754|Procedure|Epidural anesthesia|Preoperative epidural anesthesia at physician discretion
15837141|NCT04147754|Procedure|Intrathecal morphine|Preoperative intrathecal morphine at physician discretion
15837142|NCT04147754|Procedure|Erector spinae block|Preoperative erector spinae block at physician discretion
15837143|NCT04147741|Dietary Supplement|Pre-Workout Supplement|"One week familiarisation, one-week training, two weeks washout period and one-week training.
~15 Minutes before every training, the Pre-Workout Arm (PRE-W) will take a Supplement shake, consisting of some ingredients (Multi-Ingredient, explained before) and the Placebo Comparator Arm (CHO) will drink a Placebo shake, consisting of Maltodextrin."
15837144|NCT04147741|Other|Resistance Training|-Resistance Training days (Monday-Wednesday-Friday): Before training starts, Tensiomyography and Energy Feeling will be assessed (Energy Level, Fatigue Level, Feeling of Alertness, and Feeling of Focus on the task). Immediately after finishing, Tensiomyography and Performance (Vertical Jump, Overhead Medicine Ball Throw, and Maximal Mid-Tigh Pull Isometric Strength) will be assessed. Training Protocol: 10 minutes of standardized warm-up, Strength Circuit training using free weights (Parallel Squat; Bench Press; Alternate Box Set-Ups; Shoulder Press; Alternate Lunges; Up-right Row; Hip-Thrust; Squat on Isoinertial Fly-Wheel or Drop Jump). The participants will have to perform 16 repetitions of each exercise, with 30 seconds rest and 3 minutes rest after every set. If they can complete 16 repetitions easily, 2,5 to 5 kg will be added for the next set. Also, whole-body Perceptual Response will be assessed using the 0-10 OMNI-RES Scale, after every set and 15 minutes after finishing.
15837145|NCT04147741|Other|Endurance Training|- Endurance Training days (Tuesday-Thursday): Energy Feeling Questionnaire will be implemented before training. The training will consist of 30 minutes cycling at their Fatmax Intensity (~60% Vo2max) on a Cycloergometer (estimated during familiarisation week). Also, the Heart Rate will be recorded during the whole training. Besides, Perception of Effort will be assessed using the 6-20 version of the Borg Scale every 5 minutes during training and 15 minutes after it has been completed.
15837146|NCT04147728|Drug|Anlotinib|Anlotinib is a novel multi-target tyrosine Kinase inhibitor that inhibits VEGFR2/3, FGFR1-4, PDGFD α/β, c-Kit and Ret.
15837147|NCT04147728|Radiation|Stereotactic Radiosurgery|Stereotactic Radiosurgery as the initial treatment of non small cell lung cancer patients with limited brain metastases
15837152|NCT04147702|Other|Balance analysis|Balance analysis is assessment method to estimate deterioration of postural control.
15837153|NCT04147689|Device|DESIRIAL® PLUS|"DESIRIAL® PLUS is a cross-linked hyaluronic acid gel to restore volume by filling the labia majora, to rehydrate and to add tone and tension to the area of connective tissue.
~The baseline injection is performed at V1, with a maximum volume to be injected per labium of 2 ml. The exact volume will be determined by the physician in order to reach optimal volume correction.
~One optional touch-up injection of DESIRIAL® PLUS is allowed at V2 (4 weeks after Baseline), with a maximum volume to be injected per labium of 1 ml. No other touch-up injections are allowed until the end of the study."
15837154|NCT04147663|Other|describe the management of the adult population suffering from suspected seizure by the emergency structures|For 3 consecutive days, all patients with suspected epileptic seizures (assessed by the Emergency medical assistance service ( SAMU), paramedical team and the emergency unit) will be included in the study. With the use of questionnaries, information will be collected from patients or witnesses by the SAMU, the paramedical team or physicians of the emergency unit. A 7-day follow-up will be carried out by the principal investigator (PI) of each center.
15837155|NCT04147650|Drug|0.05% Voclosporin Ophthalmic Solution (VOS)|0.05% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
15837156|NCT04147650|Drug|0.10% VOS|0.10% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
15837157|NCT04147650|Drug|0.20% VOS|0.20% VOS, in both eyes (OU) twice a day (BID) over 12 weeks
15837158|NCT04147650|Drug|Vehicle Ophthalmic Solution|Vehicle Ophthalmic Solution, in both eyes (OU) twice a day (BID) over 12 weeks
15837159|NCT04147637|Combination Product|FreeStyle Libre with MiaoMiao|Use of FreeStyle Libre with MiaoMiao Bluetooth adjunct and mobile device application to enable calibration and alarms
15837160|NCT04147637|Device|FreeStyle Libre alone|Use of standard FreeStyle Libre with Libre Link app and mobile phone scanning
15837161|NCT04147624|Drug|Souvenaid|Souvenaid is an oral beverage that contains a vitamin mixture (Vitamin A, B1, B2, B3, B5, D) plus three main active ingredients: omega-3 fatty acids, uridine monophosphate, and choline.
15837162|NCT04147624|Other|Placebo|The Placebo used in this study is an oral beverage vitamin mixture containing Vitamins A, B1, B2, B3 and B5.
15837163|NCT04147611|Device|BAHA|Participant's pediatric bone conduction hearing device.
15837164|NCT04147611|Device|Wireless Audio Streaming Accessory|Cochlear Corporation's Mini Microphone 2+ Wireless Audio Streaming Accessory is an accessory used to transmit speech and sound. It consists of a microphone and a transmitter that transfers the signal to a receiver that's connected to a hearing device.
15837165|NCT04147611|Device|Digital Adaptive RM System|Sonova's Roger Digital Adaptive RM system is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid.
15837166|NCT04147611|Device|Hearing Aid|Participant's unilateral hearing aid with contralateral plug.
15837167|NCT04147598|Other|LFD|Participants will receive daily prepared food trays to achieve a diet with approximately 10% of total fat, 1-5% of calories from saturated fat, and 5-9% of MUFA and PUFA. This diet will contain an approximate ratio of 1:1 of omega-6/omega-3 fatty acids.
15837168|NCT04147598|Other|SAD|Participants will receive daily prepared food trays to achieve a diet with approximately 35-40% of calories from fat, 10-11% of saturated fats, and 25-29% would be mono-unsaturated (MUFA) and PUFA. This diet will contain a 20-30:1 ratio of omega-6/omega-3 fatty acids, representing the current SAD.
15837169|NCT04147585|Other|Intermittent Reduced Calorie Diet (IRCD)|Three cycles of a 5-day Intermittent Reduced Calorie Diet over three months.
15837170|NCT04147572|Drug|Placebo Tiotropium inhalation powder type A|Placebo inhalation from inhaler A
15837171|NCT04147572|Drug|Placebo Spiriva capsule|Placebo inhalation from HandiHaler
15837172|NCT04147572|Drug|Placebo Tiotropium inhalation powder type B|Placebo inhalation from inhaler B
15837173|NCT04147572|Device|Substudy Placebo Tiotropium Easyhaler|Substudy placebo inhalation
15837174|NCT04147572|Device|Substudy Placebo Spiriva® via HandiHaler|Substudy placebo inhalation
15837175|NCT04147559|Device|Total Hip Arthroplasty Implant|Single study group either newly or previously implanted with the PROFEMUR® Preserve Classic Femoral Stem combined with other Wright Medical Technology (WMT) or MicroPort Orthopedics Inc (MPO) THA components including acetabular shells, liners and femoral heads.
15837176|NCT04147546|Diagnostic Test|Additional screening using ultra sensitive RDTs|At each ANC visit, study nurses will perform an HS-RDT for participants in the intervention arm
15837177|NCT04147546|Drug|Dihydroartemisinin-piperaquin|All pregnant women with a positive HS-RDT will be treated with a full course of dihydroartemisinin-piperaquine (DP) over 3 days. The first dose of DP will be administered under direct observation at the antenatal care clinic (ANC) and the subsequent doses of the intervention in days 2 and 3 will be taken unsupervised at home
15837178|NCT04147546|Other|Reminders|Before each scheduled ANC visit, reminders using SMS or phone call will be used. This is order to increase ANC attendance
15837179|NCT04147533|Drug|Imatinib withdrawal|withdrawal of imatinib after previous two-step dose reduction: during the first 6 months after study entry, the dose of imatinib is 50% of the standard dose (200 mg daily), during the second 6 months after study entry, the dose of imatinib is 200 mg every other day; 12 months after study entry, imatinib is discontinued, the patient is followed in line with the aims of the trial
15837180|NCT04147533|Drug|Dasatinib|withdrawal of dasatinib after previous two-step dose reduction: during the first 6 months after study entry, the dose of dasatinib is 50% of the standard dose (40 mg daily; tablets containing 50 mg are not available on the market), during the second 6 months after study entry, the dose of dasatinib is 40 mg every other day; 12 months after study entry, dasatinib is discontinued, the patient is followed in line with the aims of the trial
15837181|NCT04147533|Drug|Nilotinib|withdrawal of nilotinib after previous two-step dose reduction: during the first 6 months after study entry, the dose of nilotinib is 50% of the standard dose (200 mg every 12 hours), during the second 6 months after study entry, the dose of nilotinib is 400 mg every other day; 12 months after study entry, nilotinib is discontinued, the patient is followed in line with the aims of the trial
15837182|NCT04147520|Behavioral|Brief Motivational Interview|Single (60 min) session discussion of alcohol use and associated experiences.
15837217|NCT04147221|Drug|Imipenem-relebactam|After receipt of imipenem-relebactam, participants will have six blood samples collected over 6 hours for determination of imipenem and relebactam concentrations.
15837183|NCT04147507|Other|Passive Music Therapy|Music group (N=15) will receive listen to music therapy passively for 20 minutes/day, 5 days/week for 4 weeks, along with lifestyle modifications. Music therapy will be provided via headphones in an isolated quiet non-disrupted room, with room temperature maintained between 20-22 degree Celsius and having medium light intensity. Participants would be instructed to listen to music with eyes closed in sitting position, back supported in comfortable position on a chair. The participants will be given 5 minutes' rest in sitting position before and after each music therapy session.
15837184|NCT04147507|Behavioral|Control|Control group (N=15) would receive only lifestyle modification. Handout of lifestyle modification according to the Seventh Joint National Committee (JNC VII) report guidelines will be given to all participants. Participants would be instructed to not participate in any form of physical activity and to focus only on two components from the guideline which includes practice the DASH eating plan (diet rich in fruits and vegetables, low fat dairy or unsaturated fat) and limit the daily sodium intake (less than 100 mmol per day).
15837185|NCT04147494|Procedure|Computed Tomography|Undergo PET/CT scan
15837186|NCT04147494|Radiation|Gallium Ga 68 FAPi-46|Given IV
15837187|NCT04147494|Radiation|Gallium Ga 68-labeled PSMA-11|Given IV
15837188|NCT04147494|Procedure|Positron Emission Tomography|Undergo PET/CT scan
15837189|NCT04147481|Other|Group Abdominal Nerve Block with local anesthetics|surgical under general anesthesia combined with transversus abdominis plane block (TAPB) and/or rectus sheath block (RSB) with 0.2% ropivacaine
15837190|NCT04147481|Other|Group Abdominal Nerve Block with saline|surgical under general anesthesia combined with transversus abdominis plane block (TAPB) and/or rectus sheath block (RSB) with not 0.2% ropivacaine but 0.9% saline.
15837191|NCT04147468|Other|Virtual Reality|For the VR intervention, we focus on using our developed VR gaming platform called Super Pop VR, a VR system that can be individualized to the movement capabilities of the participant. The research team will travel to the family to conduct the intervention to ensure the treatment adherence. The participants will be asked to move their arms to 'pop' as many virtual objects as possible.
15837192|NCT04147468|Other|Functional Strength Training|For the functional strength training, participants will receive repetitive progressive resistance exercise during goal-directed functional activity with the participants focus on the activity being performed. The research team will also go to the family to conduct the FST intervention.
15837193|NCT04147455|Behavioral|Adapted RealConsent|The program is a novel, theory-driven, evidence-based serial drama and educational program tailored to young men and delivered in six episodes via the web. Participants will view six 30-minute modules designed to prevent sexual violence in young men
15837194|NCT04147455|Behavioral|Health Education Control Condition|Participants will view six 30-minute web-based serial drama modules designed to promote health.
15837195|NCT04147442|Device|Hearing aid with fine-tuned and standard programs|A digital, wireless hearing aid is programmed specifically to each subject's hearing loss and fitted with both a program that is fine-tuned for their specific music playing as well as the standard music program that uses pre-determined settings.
15837196|NCT04147429|Behavioral|Early Literacy Intervention|Similar to the standard Reach out and Read model, parents will be given a high-contrast board book, Cluck and Moo, and education about the importance of and how to engage with newborns in early shared reading behaviors. This will include instructive information for families about using books to stimulate newborns through pictures and spoken words.
15837197|NCT04147416|Drug|HSK3486 0.1-0.2 /0.3 mg / kg group|Administered with HSK3486 at a loading dose of 0.1-0.2 mg/kg via intravenous pump. Then HSK3486 shall be administered immediately at an initial maintenance dose of 0.3 mg/kg/h respectively.
15837198|NCT04147416|Drug|Propofol 0.5-1.0/1.5 mg/kg group|Administered with Propofol at a loading dose of 0.5-1.0mg/kg via intravenous pump. Then Propofol shall be administered immediately at an initial maintenance dose of 1.5 mg/kg/h respectively.
15837199|NCT04147390|Drug|prescribe topical 0.03 % tacrolimus|prescribe topical 0.03 % tacrolimus 3 times a day for 12 months
15837200|NCT04147390|Drug|prescribe mycophenolate mofetil(MMF)|MMF orally 1 g twice daily for the first 6 months and then 1 g daily for the next 6 months
15837201|NCT04147377|Behavioral|behavioral intervention based on sensory cues|Patients will receive behavior intervention training that includes how to apply visual and auditory cues to freezing of gait in real clinical practice.
15837202|NCT04147364|Other|no intervention|only retrospective reviews for medical records
15837203|NCT04147351|Drug|Atezolizumab Injection; bevacizumab Injection|a PD-L1 inhibitor; anti-angiogenesis
15837204|NCT04147338|Drug|Guselkumab|Guselkumab will be administered subcutaneously.
15837205|NCT04147325|Drug|Antiretroviral Therapy|ART will be administered chosen by the investigator according to country/ local standards/ guidelines/ available ARV for current treatment guidelines for rapid initiation.
15837206|NCT04147312|Drug|Fufang E'Jiao Jiang|Fufang E'Jiao Jiang, 20milliliters(mL) once, 3 times a day, continuous intervention for 21 days each cycle, and use 2 cycles
15837207|NCT04147312|Drug|placebo containing low-dose fufang E'Jiao Jiang|placebo containing low-dose Fufang E'Jiao Jiang, 20mL once, 3 times a day, continuous intervention for 21 days each cycle, and use 2 cycles
15837208|NCT04147286|Drug|Atorvastatin 40mg|12 weeks of 40 mg atorvastatin therapy per os
15837209|NCT04147286|Drug|Placebo oral tablet|Identical placebo
15837210|NCT04147273|Device|Determination of postprandial glucose response by continuous glucose measurement after consuming different carbohydrate containing foods|"One day prior to the study beginning, participants were equipped with a CGM system (FreeStyle Libre®, Abbott Diabetes Care, Alameda, CA, USA). This CGM system provides glucose recordings every 15 min over a period of 14 days. The glucose data were downloaded manually by a scan with a handheld device.
~On the second day of the study, participants consumed portions of these three test products containing 50 g of available carbohydrate on 3 separate days without a washout period. The products were tested in random order at the same time of the morning after a 10 h overnight fast. Venous blood samples were collected at 0, 15, 30, 45, 60, 75, 90, 105 and 120 min postprandial by inserting an intravenous cannula into a forearm vein. Capillary blood samples were obtained through finger pricking. Blood glucose levels in these samples were measured with a high quality SMBG system (ContourXT/Contour next, Ascensia Diabetes Care, Leverkusen, Deutschland, Germany)."
15837211|NCT04147260|Drug|BI 730357|Film-coated tablet
15837212|NCT04147260|Drug|Placebo to match BI 730357|Film-coated tablet
15837219|NCT04147208|Drug|RTV|Administered RTV 100 mg orally three times daily in fed state
15837220|NCT04147208|Drug|ETV|Administered orally ETV 0.5 mg once daily in fasted state
15837223|NCT04147182|Drug|Hypertonic Saline 3%|3% and 5% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, hypertonic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. The pH may have been adjusted with hydrochloric acid. It contains no antimicrobial agents.
15837224|NCT04147169|Behavioral|Focused end-of-life conversations to promote connections among patients, family members and clinicians.|All eligible patients and families who were invited to participate in wish elicitation and implementation. For family interviews, criterion sampling was used. For the clinician focus groups, criterion sampling was used, based on involvement in the care of a 3WP patient. For the manager/hospital administrator interviews, purposive sampling was used, based on relevant leadership positions. Investigators employed qualitative and quantitative methods to collect and analyze data. Quantitative data include characteristics of patients, families and clinicians, questionnaire responses from families who agree to interviews, and clinicians who agree to focus groups, respectively, types of wishes elicited and implemented, and their cost. Qualitative data was obtained through individual family interviews, inter-professional clinician focus groups, project team field notes, additional ideas about the costs and benefits of the project from manager interviews, and analysis of project documents.
15837225|NCT04147156|Procedure|Epley's Maneuver|Treatment with Epley's Maneuver in the ROTUNDUM-chair
15837226|NCT04147156|Procedure|Semont Maneuver|Treatment with the Semont Maneuver in the ROTUNDUM-chair
15837227|NCT04147156|Procedure|360 degree vertical rotation|Treatment with 360 degree vertical rotation in the ROTUNDUM-chair
15837228|NCT04147143|Other|Documentation|Retrospective chart review of patients who have already completed treatment with cabozantinib after nivolumab or nivolumab plus ipilimumab before inclusion.
15837229|NCT04147130|Other|MultiPAP Plus|Complex intervention incorporating previous MultiPAP intervention (based on the ARIADNE principles with two main components: 1) Training of general practitioners and 2) Patient-centered clinical interview) And it adds a clinical-decision support system to help structured treatment-plan review.
15837230|NCT04147130|Other|Usual care|Patients will receive the usual clinical care based on current clinical practice guidelines.
15837231|NCT04147117|Device|Cervical pessary|Cervical pessary is a silicone ring with a smaller diameter to be fitted around the cervix and a larger diameter to fix the device to the pelvic floor. It modifies the direction of the cervix to the posterior vaginal wall.
15837232|NCT04147104|Device|Low flow ECCO2R|"Treatment with a medical device called ECCO2R. The device consists of a drainage cannula placed in a large central vein, a membrane lung (artificial gas exchanger), and a return cannula into the venous system. Blood is pumped through the membrane lung, and CO2 is removed by diffusion. A flowing gas known as sweep gas containing little or no CO2 runs along the other side of the membrane, ensuring a diffusion gradient from blood to the other side, hence promoting CO2 removal."
15837233|NCT04147104|Device|Invasive mechanical ventilation|Invasive mechanical ventilation deviceto support acute respiratory failure and facilitate exhalation via an endotracheal tube or tracheotomy.
15837234|NCT04147091|Other|ApaCare & Repair|Initial cariuos lesions were treated.
15837235|NCT04147078|Biological|DC vaccine subcutaneous administration|subcutaneous administration
15837236|NCT04147065|Drug|Duration of eradication regimen|14 day eradication regimen
15837237|NCT04147052|Behavioral|iSLEEPms|Participants randomized to iSLEEPms complete daily online sleep diary forms and weekly online educational modules. Modules focus on typical elements of CBT-I, adapted for individuals with MS: education about sleep in MS, sleep restriction, and stimulus control; sleep hygiene and relaxation; and cognitive restructuring around sleep and coping with MS. Sleep diaries are scored each week, and feedback is provided to participants to guide adjustments to their recommended bedtimes and wake times. Telephone support is available to provide clarification around module content.
15837238|NCT04147039|Behavioral|MINISTOP 2.0|The MINISTOP 2.0 is a behavioural change program aiming to promote healthier diet and physical activity among 2.5-year-old children. The program consists of features such as information, monitoring and feedback (dietary key variables, physical activity, screen time) and it is built around 13 themes during the 6-month period.
15837239|NCT04147026|Device|SinnoTest®|"The selection of the biotherapy is carried out based on the recommendations of SinnoTest®. This test categorizes the bDMARDs based on the probability of response. It will allow to prescribe both original molecules, as well as biosimilars, in an equivalent way.
~In the SinnoTest® arm, the investigator prescribes the treatment defined as the most effective by SinnoTest®, except in case of contraindication. If contraindicated, the investigator prescribes the second-choice treatment (if any) of SinnoTest® in terms of efficacy."
15837240|NCT04147026|Other|Biotherapy prescription without SinnoTest® software|The rheumatologist will use the current guidelines of rheumatoid arthritis to choose the more adapted biotherapy treatment to the patient
15837241|NCT04147013|Drug|Celecoxib|Patients will receive celecoxib 200 mg PO BID for 7 days post endoscopic sinus surgery, starting on the evening of the day of surgery.
15837242|NCT04147013|Drug|Placebo|Patients will receive placebo PO BID for 7 days post endoscopic sinus surgery, starting on the evening of the day of surgery.
15837243|NCT04146987|Procedure|Rotator cuff repair surgery|Patients will undergo open rotator cuff repair or arthroscopic rotator cuff repair
15837244|NCT04146961|Device|Alcon PanOptix or PanOptix Toric IOL|Patients who previously underwent cataract surgery with the Alcon PanOptix or PanOptix Toric IOL in both eyes.
15837245|NCT04146948|Other|no intervention|no intervention in this study
15837246|NCT04146935|Drug|Burosumab Injection [Crysvita]|Burosumab/Crysvita SC injection monthly
15837247|NCT04146922|Other|Step down to oral antimicrobial therapy|Step down from intravenous to oral antimicrobial therapy to complete the intended course of treatment.
15837248|NCT04146922|Other|IV antimicrobial therapy|No step down from intravenous to oral antimicrobial therapy to complete the intended course of treatment.
15837280|NCT04146662|Diagnostic Test|Faecal immunochemical test|Faecal immunochemical test (FIT) and urine volatile organic compounds (VOC) analysis.
15837249|NCT04146909|Diagnostic Test|Hyperinsulinemic-euglycemic clamp|After an overnight fast and an equilibration period lasting 2 hours, the 2-step euglycemic-hyperinsulinemic clamp study will be performed. A primed-continuous infusion of regular insulin will be given at 8 mU/(m2 × min) during the first 2 hours, and increased to 40 mU/(m2 × min) for the subsequent 2 hours. Plasma glucose levels will be measured every 5 min, and a variable glucose infusion will be initiated to maintain levels at ∼90 mg/dl. Plasma samples will be drawn at baseline and throughout the infusion period for measurement of isotope enrichment, insulin, NEFA, glycerol turnover, and additional hormones which may be altered with lactation. Approximately 160 mL of blood will be drawn at this visit.
15837252|NCT04146883|Drug|Antibiotics|Post-procedural one-day iv cefazolin then 3-day prophylactic cephalexin
15837253|NCT04146870|Other|not have|not have
15837254|NCT04146857|Other|Normoxia|Nap in hypoxia chamber at 20.9% oxygen (36 m asl)
15837255|NCT04146857|Other|Hypoxia 1|Nap in hypoxia chamber at 15.0% oxygen (simulates 2660 m asl)
15837256|NCT04146857|Other|Hypoxia 2|Nap in hypoxia chamber at 12.8% oxygen (simulates 4000 m asl)
15837257|NCT04146831|Drug|Sintilimab|Sintilimab: intravenous, 200mg, every 3 week. Course of treatment: Stop the treatment until clinical or radiographic progression occurs.
15837258|NCT04146818|Behavioral|Adapted Tango Dancing|Treatment will include sessions of Adapted Tango (90 min per week for a total of 6 months) together with sessions of comprehensive cognitive intervention (90 min per week for a total of 6 months) consisting in music therapy, engagement in social activities, cognitive training and psycho-education.
15837259|NCT04146818|Behavioral|Control|Sessions of psycho-education and advice on healthy life-style (once per month for a total of 6 months)
15837260|NCT04146805|Drug|BLD-0409|For each cohort in both study parts, 8 subjects will be randomized in a 6:2 ratio to active (BLD-0409) : control (matched placebo). Study drug will be administered orally once a day, with an option to evaluate twice daily dosing (BID) in Part 2 MAD cohort(s).
15837261|NCT04146805|Drug|Control: Placebo|Subjects will be randomized in a 6:2 ratio to control (matched placebo). Study drug will be administered orally once a with an option to evaluate twice daily dosing (BID) in Part 2 MAD cohort(s).
15837262|NCT04146792|Behavioral|body acceptance program|Complete 3 writing exercises over the course of week. Each writing exercise will take approximately 15 minutes to complete
15837263|NCT04146792|Behavioral|writing creatively program|Complete 3 writing exercises over the course of week. Each writing exercise will take approximately 15 minutes to complete
15837264|NCT04146779|Behavioral|Yoga Video|A guided practice that includes gentle stretching of the jaw, neck and shoulders. It lasts approximately 25 minutes.
15837265|NCT04146779|Behavioral|Posture and Strengthening Video|The strengthening video directs patients through a sequence of isometric exercises to strengthen neck, shoulder and core muscles that are critical for good posture and musculoskeletal integrity. The patient may opt to do the strengthening exercises standing, sitting or with their back on the floor depending on their strength. The video lasts 20 minutes.
15837266|NCT04146779|Behavioral|Relaxation Video|The relaxation video uses meditative techniques to quiet and calm the mind. The video lasts 15 minutes
15837267|NCT04146779|Behavioral|Breath Work Video|The breath work video will guide patients through a series of abdominal and chest breathing exercises. The video lasts 15 minutes.
15837268|NCT04146779|Behavioral|Satisfaction Survey|Participants will complete a questionnaire addressing satisfaction with the yoga program.
15837269|NCT04146779|Behavioral|Guided Yoga Session|Instructor guided yoga session twice a week
15837270|NCT04146779|Behavioral|Written Yoga Instructions|Introduction to Yoga and Yoga poses
15837271|NCT04146766|Combination Product|eHealth|The study was randomized (wait-list-control), and it was estimated that 60 subjects were randomly assigned to the immediate treatment group and the wait-list-control group. The two groups were tested for baseline before intervention in the eHealth. After the first questionnaire evaluation, the experimental group was involved in the eHealth for three months, and after three months, the experimental group and the waiting intervention control group were post-tested. To assess the effectiveness of the two groups before and after the eHealth . Control group that waits for intervention in the fourth month from the beginning of the fourth month to the end of the sixth month
15837272|NCT04146740|Other|Structured Exercise for Experimental (Structured Exercise) Group|"Structured aerobic exercise regime of moderate intensity by using stationary cycle (3-5 MET) 10 min, brisk walk 10 min.
~The combination of Stabilization exercise (10 repeatitions) and PFM training ( 20 repeatitions set).
~Relaxation therapy including Mitchells physiological relaxation technique (10 repetitions) along with deep breathing exercises."
15837273|NCT04146740|Behavioral|Control treatment for both groups|Medical and dietary interventions like insulin in addition of the postural education and back care from Physical Therapist.
15837274|NCT04146714|Other|Substance use questionnaire|Screening questionnaire about substance use based on the Detection of Alcohol and Drug Problems in Adolescents (DEP-ADO) survey.
15837275|NCT04146714|Other|Physical activity questionnaire|Screening questionnaire about physical activity, based on the short version of the International Physical Activity Questionnaire (IPAQ).
15837276|NCT04146701|Other|Blood draw|venous blood withdraw (ca. 40ml)
15837277|NCT04146688|Other|Music Balance Board|The SSM is measured with an innovative tool (Music Balance Board) developed at the University of Ghent (Belgium) and specially designed to record the movements of the elderly in a natural and comfortable position This chair is equipped with a tablet and sensors that record the movements of the hand and body during the SSM to a musical sequence. The analysis will focus on the difference between the participant's striking and the beat of the music measured using this chair.
15837278|NCT04146675|Device|TRICOT JERSEY VANISE DOUBLE FACE|"Short sleeve t-shirt : TRICOT JERSEY VANISE DOUBLE FACE  THERMOLACTYL EVOLUTION  with ceramic fibers.
~A Tinetti test will be performed while wearing the T-shirt, as well as an evaluation of the equilibration on posturography platform under static conditions and an assessment of dynamic equilibrium and locomotion in motion analysis."
15837279|NCT04146675|Device|TRICOT JERSEY SIMPLE|Short sleeve t-shirt : TRICOT JERSEY SIMPLE The comparator T-shirt has the same weight, the same appearance, and will be used by patients in the same way and under the same conditions as the T-shirt with ceramic fibers.
15837281|NCT04146649|Procedure|Arthrocentesis|Patients will receive a joint arthrocentesis to remove fluid from the joint.
15837282|NCT04146636|Diagnostic Test|e-LIFT|Diagnostic procedure: elastography devices, blood tests (e-LIFT), liver biopsy if necessary (elstometry ≥ 8 kPa and < 15 kPa)
15837283|NCT04146623|Biological|CodaVax-H1N1 influenza vaccine|CodaVax-H1N1, a live attenuated vaccine (LAIV) strain based on the A/California/07/2009 (H1N1) influenza virus, administered once intranasally via a sprayer at a dose of 8 x10^5 plaque forming units (PFU).
15837284|NCT04146623|Biological|Normal Saline Placebo|Saline (0.9%) administered intranasally via sprayer
15837285|NCT04146610|Drug|an antibody drug conjugate|Multiple dose grouping
15837286|NCT04146597|Other|Neural mobilization|Neural mobilization (NM) is a physiotherapy method aimed at restoring the dynamic balance between the relative movement of neural tissues and surrounding mechanical interfaces, and different techniques are used for the treatment of various compression syndromes as well as other pain conditions, such as back and neck pain (Basson et al., 2017; Ellis and Hing, 2008). The main techniques used are neurodynamic sliders and neurodynamic tensioners, with the tensioning techniques being considered the more aggressive approach, in which the increase in nerve length occurs (Silva et al., 2014). The neurodynamic sliders techniques are gentle maneuvers as they involve nerve lengthening at one joint and simultaneous reduction in its length at an adjacent joint in order to produce sliding movements of neural structures relative to adjacent tissues (Efstathiou et al., 2015).
15837287|NCT04146584|Device|Sofwave Treatments|The device used in this study will be the SofWave system manufactured by SofWave Medical ltd. The SofWave device is an ultrasonic system combined with an inherent cooling system that generates High Intensity non-focused Ultrasonic pulses (HIUS), causing a controlled thermal damage by elevating the temperature to 60-70°C in the dermis layer while sparing the epidermal layer using surface cooling. Each patient would receive 2 Sofwave treatments on the face and/or the neck.
15837288|NCT04146571|Drug|Ensartinib|Oral, ALK inhibitor
15837289|NCT04146558|Drug|Individualized internal ayurvedic treatment|"All possible internal preparations will be administered for a period of 12 months.
~All administered preparations with its dosage and duration will be documented All preparations will be subjected to lab test for clearing heavy metal and pesticide content before the administration"
15837290|NCT04146558|Other|External ayurvedic treatment|Application of warm external oil (Ayyapala kera tailam) on affected parts twice daily
15837291|NCT04146545|Behavioral|Community Rx-Caregiver Resources|A tailored list of resources addressing health-related social needs (HRSN) for caregivers and access to an online community resource finder.
15837292|NCT04146532|Drug|Aspirin 500 MG|Single 500mg aspirin capsule.
15837293|NCT04146532|Drug|Placebo|Single 500mg placebo capsule.
15837294|NCT04146519|Biological|Autologous mesenchymal stem cells|Autologous mesenchymal stem cells
15837295|NCT04146519|Other|Placebo|Saline solution
15837296|NCT04146506|Other|Muscle stretching exercises|Muscle stretching exercises consisting of static stretching exercises of the knee flexors
15837297|NCT04146493|Diagnostic Test|Blood samples for Heparin-binding protein measurement|Blood samples before and after given heparin
15837298|NCT04146480|Diagnostic Test|F18-NaF PET/CT|"The scan will be performed on the Discovery 690 Nuclear Medicine Camera. On the day of the scan, the patient will be admitted to the Office of Nuclear Medicine and will be admitted to administrative. Prior to the scan, the subject will undergo a brief interview by a physician or nurse and a 22 G Prefill will be installed on him, through which a 5 millikiric (mCi) of 18 F-NaF will be injected.
~4. An hour after the injection, the PET / CT scan, which will last about 10 minutes, during, the patient is required to lie down and breathe normally.
~5. Upon completion of the scan, will be released without any restrictions."
15837299|NCT04146467|Device|Renuvion APR Device|The Renuvion APR Handpiece is a sterile, single use electrosurgical (monopolar) device intended to be used in conjunction with compatible generators for the percutaneous delivery of radiofrequency energy and/or helium plasma for cutting, coagulation and ablation of soft tissue. Radiofrequency energy is delivered to the handpiece by the generator and used to energize the electrode. When helium gas is passed over the energized electrode, a helium plasma is generated for soft tissue cutting, coagulation or ablation. The Renuvion APR Handpiece has a non-extendable electrode to generate helium plasma.
15837300|NCT04146454|Other|Smartphone-based balance exercises|A smartphone-based wearable telerehabilitation system will provide video and audio instructions on how to perform in-home dynamic weight-shifting balance exercises (i.e., physical therapists' recommended dynamic balance exercises).
15837301|NCT04146441|Combination Product|SonoVue|1,0 ml SonoVue 8ul/ml dispersion is given 9 times at 3,5 minute intervals 9 times, a total dosage of 9 ml. The experimental treatment lasts for 31,5 minutes every treatment day. Administered by authorized site personnel only
15837302|NCT04146441|Drug|Chemotherapy|FOLFIRINOX Regime according to Norwegian national guidelines
15837303|NCT04146428|Behavioral|clinician-mediated JASPER|JASPER is a developmentally anchored behavioral intervention that assumes that communication develops from social interactions in which specific social engagement strategies, symbolic representations, and early communication forms are modeled and naturally reinforced by the adult's responses to the child. The adult referred in this condition is the clinician/therapist.
15837304|NCT04146428|Behavioral|parent-mediated JASPER|JASPER is a developmentally anchored behavioral intervention that assumes that communication develops from social interactions in which specific social engagement strategies, symbolic representations, and early communication forms are modeled and naturally reinforced by the adult's responses to the child. The adult referred in this condition is the parent.
15837305|NCT04146415|Diagnostic Test|Spect scan with mTc99-PYP|. About forty-five minutes after the injection mTc99-PYP , flanner and SPECT-CT mappings will be performed and then the patient will move to the CZT camera and undergo another photograph.
15837306|NCT04146402|Drug|SCT-I10A+chemo|SCT-I10A, 200 mg intravenous (IV) on Day 1 of each 3-week cycle Standard chemotherapy: Cisplatin+5-FU
15837307|NCT04146402|Drug|Placebos+chemo|Placebo, 200 mg intravenous (IV) on Day 1 of each 3-week cycle Standard chemotherapy: Cisplatin+5-FU
15837308|NCT04146376|Other|Use of a postpartum diary and additional blood draws|"A diary will be used to capture postpartum hemorrhage (PPH), Wilate and tranexamic acid use, other drug use, bleeding episodes, and treatment schedules.
~Several blood draws additional to what is expected for routine clinical care will also be taken."
15837382|NCT04145778|Other|non interventionnal study|non interventionnal study
15837309|NCT04146376|Drug|VWF replacement therapy with Wilate|This study design uses on-label Wilate for VWF replacement therapy for delivery and the postpartum period in VWD patients whose VWF levels are <100% in the third trimester of pregnancy
15837310|NCT04146376|Drug|Tranexamic acid|This study design uses tranexamic acid for prophylaxis for postpartum hemorrhage for all women with VWD
15837311|NCT04146376|Other|Use of a postpartum diary and additional blood draws.|"A diary will be used to capture postpartum hemorrhage (PPH), tranexamic acid use, other drug use, bleeding episodes, and treatment schedules.
~Several blood draws additional to what is expected for routine clinical care will also be taken."
15837312|NCT04146363|Biological|Lebrikizumab|Subcutaneous injection
15837313|NCT04146363|Other|Placebo|Subcutaneous Injection
15837314|NCT04146350|Procedure|PPV+/-Cat|pars plana vitrectomy+/-cataract
15837315|NCT04146350|Procedure|PPV+/-Cat+Gas|pars plana vitrectomy+/-cataract+gas tamponade
15837316|NCT04146350|Procedure|PPV+ILM+/-Cat+/-Gas|pars plana vitrectomy+internal limiting membrane peeling+/-cataract+/-gas tamponade
15837317|NCT04146350|Procedure|PPV+ILM+/-Cat+/-Oil|pars plana vitrectomy+internal limiting membrane peeling+/-cataract+/-silicone oil tamponade
15837318|NCT04146350|Procedure|PSR|posterior scleral reinforcement
15837319|NCT04146350|Procedure|PSR+ PPV+ILM+/-Cat+/-Oil （or Gas）|posterior scleral reinforcement+pars plana vitrectomy+internal limiting membrane peeling+/-cataract+/-silicone oil tamponade (or gas)
15837320|NCT04146350|Procedure|Gas|gas tamponade alone
15837321|NCT04146337|Biological|FMT|Fecal microbiota in frozen capsules
15837322|NCT04146324|Drug|nivolumab|Administered as adjuvant therapy as per the market authorization in Australia
15837323|NCT04146311|Drug|Hypertonic saline|A bolus injection (0.25 ml) of hypertonic saline (5%) into the left infrapatellar fat pad.
15837324|NCT04146311|Drug|isotonic saline|A bolus injection (0.25 ml) of isotonic saline (5%) into the left infrapatellar fat pad.
15837325|NCT04146311|Other|Motor training|All the subjects recruited need to have a short-term motor task training at home. 30 times a session, totally 2 sessions a day for 6 days
15837326|NCT04146298|Drug|Cyclophosphamide|Cyclophosphamide will be administered prior to cell infusion.
15837327|NCT04146298|Drug|Fludarabine|Fludarabine will be administered prior to cell infusion.
15837328|NCT04146298|Biological|Mutant KRAS G12V-specific TCR transduced autologous T cells|After preconditioning regimen, T cells will be infused to the patient intravenously in the Patient Care Unit over approximately 30 to 50 minutes.
15837329|NCT04146298|Drug|Anti-PD-1 monoclonal antibody|During the treatment, anti-PD-1 monoclonal antibody will be administered if needed.
15837330|NCT04146285|Drug|BAT4406F|"Open-label dose escalation starting from 20mg.
~Route of administration: intravenous infusion."
15837331|NCT04146272|Device|Hearing Aid Mermaid Current|The current hearing aid used to treat hearing loss.
15837332|NCT04146272|Device|Hearing Aid Mermaid New|The new hearing aid used to treat hearing loss with an upgraded feedback cancellation system.
15837333|NCT04146272|Device|Power Hearing Aid Current|The current power hearing aid used to treat strong hearing loss.
15837334|NCT04146272|Device|Power Hearing Aid New|The new power hearing aid used to treat strong hearing loss with an upgraded feedback cancellation system.
15837335|NCT04146259|Drug|calcium carbonate and alphacalcidol|treatment for hypocalcemia
15837336|NCT04146246|Diagnostic Test|G6PD assay|A test for G6PD deficiency.
15837337|NCT04146233|Other|Point of care gastric ultrasound|Point-of-care gastric ultrasound will be performed using a low-frequency curvilinear ultrasound probe to assess stomach contents (empty vs. not empty, liquid vs. solid, gastric volume).
15837338|NCT04146220|Drug|Prednisolone|Patients of the low and the high dose groups recieved prednisolone in different dose for initial 4 weeks, then tapered gradually. Both groups received pulse I/V methylprednisolone 500 mg/day daily for initial 3 days and monthly cyclophosphamide infusion 750-1000 mg/m2 body surface area.
15837339|NCT04146207|Drug|SHR0302|SHR0302 po QD
15837340|NCT04146207|Drug|Prednisone|Prednisone 1mg/kg/d po
15837341|NCT04146194|Other|None. This is a non-interventional observational study.|None. This is a non-interventional observational study.
15837342|NCT04146181|Drug|PD-1|SCT-I10A, 200 mg intravenous (IV) on Day 1 of each 3-week cycle.
15837343|NCT04146168|Diagnostic Test|Ultrasound|Closure of previously treated veins (with Venaseal) will be assessed via ultrasound.
15837344|NCT04146155|Drug|Liraglutide+standard-of-care treatment|"Liraglutide is available if pre-filled pens (6 mg/ml) as a solution for injection (Victoza®). One ml of solution contains 6 mg of Liraglutide (human glucagon-like peptide-1 analogue produced by recombinant DNA technology in Saccharomyces cerevisiae). One pre-filled pen contains 18 mg Liraglutide in 3 ml.
~Liraglutide is added to existing standard-of-care treatment containing one or more oral anti-hyperglycemic agents or insulin or a combination of these agents with the exception of other incretin and SGLT2i therapies in accordance with local clinical practice guidelines."
15837345|NCT04146155|Other|standard-of-care treatment|Standard-of-care treatment including: metformin should be given as the first line therapy as long as it is tolerated and not contraindicated; other agents, including sulfonylureas or glucosidase inhibitor or insulin, should be added to metformin .Glycemic control will be managed by the investigators in accordance with local clinical practice guidelines by the adjustment of concomitant glucose-lowering agents or the addition of new antidiabetic medications with the exception of incretin and SGLT2i therapies. This approach expect to yield similar glycemic control in the two study groups.
15837346|NCT04146142|Procedure|Transperineal prostate biopsy with or without antibiotic prophylaxis|As described above.
15837347|NCT04146129|Drug|CDX-0159|Single dose of one of four dosages of CDX-0159
15837348|NCT04146129|Drug|Normal saline|Single infusion of normal saline
15837349|NCT04146116|Drug|intranasal povidone-iodine|povidone-iodine USP, 10% w/w antiseptic
15837350|NCT04146103|Drug|Novex|Novex® made of Pumpkin Seed Extract 550mg, Soy Germ Isoflavonoids 50 mg and Cranberry 50mg. The dose is 2 tablets/day taken orally.
15837351|NCT04146090|Other|Low-pressure pneumoperitoneum|Pneumoperitoneum will be maintained in 10 mmHg
15837352|NCT04146090|Other|Standard pressure pneumoperitoneum|Pneumoperitoneum will be maintained in 14 mmHg
15837383|NCT04145765|Other|correlation|the subjects completed the questionnaires
15837599|NCT04144023|Biological|Granulocyte-Macrophage Colony-Stimulating Factor|Given intradermally
15837353|NCT04146064|Other|Breathprint analysis and patient-reported outcomes|"Breathprint analysis: Patients will be providing breathprint samples into the eNose device at baseline and every 12 weeks thereafter as long as on immunotherapy treatment.
~Questionnaires will be completed at the same timepoints."
15837354|NCT04146051|Drug|Descartes-08|Autogolous T-cells expressing a chimeric antigen receptor directed to BCMA
15837355|NCT04146038|Drug|Azacitidine|Given IV
15837356|NCT04146038|Drug|Decitabine|Given IV
15837357|NCT04146038|Drug|Salsalate|Given PO
15837358|NCT04146038|Drug|Venetoclax|Given PO
15837359|NCT04146025|Behavioral|Nature Coach Intervention|"Home visit. During the 1-hour home visit, the coach will (a) provide education about the health benefits of nature, (b) identify nearby nature targets for the participant to visit, (c) complete a pre-commitment contract based on individualized weekly nature goals, and (d) brainstorm barriers and solutions to reaching the goals.
~Personalized weekly text messages. Texts will serve as reminders of goals set with the Nature Coach, as well as encouragement to meet the goals. The context of text messages with change slightly based on individual participants, the goals they set, and the barriers they identify.
~Goal feedback- At the end of each week, participants will receive a progression badge via text message that shows the amount of days and time they spent in nature, and how this matched up to the goal set with the Nature Coach."
15837360|NCT04146012|Device|Artegraft® Collagen Vascular Graft™ (Artegraft)|The Artegraft is intended for use distal to the aorta as a segmental arterial replacement, as an arterial bypass, as an arteriovenous shunt where more conventional methods have proven inadequate, or as an arterial patch graft.
15837361|NCT04145999|Procedure|PRP application|The study participant will receive topical anesthesia with lidocaine ointment (50mg/g). After 5 minutes the face will be cleaned with 0.5% alcohol chlorhexidine solution. The newly obtained platelet-rich plasma activated with 10% calcium chloride packed in a 5mL syringe will be applied to the face using a 30G needle in the frontal, lateral periorbital, nasogenian sulcus, bilateral malar region and an infra-auricular point. 0.1ml per cm2 will be injected, totaling 43 points. Only one application of PRP will be performed at the defined points.
15837362|NCT04145999|Other|Placebo PRP application|Blood collection will be performed normally, the time between collection and application of saline will be the same as the PRP protocol, but in this case, the blood will be discarded, only a sample to quantify the number of platelets will be sent for analysis.
15837363|NCT04145999|Radiation|Photobiomodulation|Photobiomodulation will be applied with a Cosmedical LED face mask (São Paulo, Brazil) containing 92 red LEDs. The applications will occur in the experimental periods of 0, 3, 7, 14, 21 and 28 days after the application of PRP or placebo.
15837364|NCT04145999|Other|Placebo Photobiomodulation|Participants will not be aware of whether or not they have received the PBM application as they will be using eye protection and the researcher will position the equipment at the irradiation locations on all participants. The characteristic sound of the device will be triggered by recording in the placebos groups for the PBM. The placebo applications will occur in the experimental periods of 0, 3, 7, 14, 21 and 28 days after the application of PRP.
15837365|NCT04145934|Behavioral|ADSTEP|ADSTEP is a training program of six weekly one-on-one sessions with a physical therapist intended to reduce falls among people who use a hand-held walking aid, such as a cane or a walker. ADSTEP focuses on training in the use of the walking aid, and includes gait evaluation, walking aid selection and fitting, and progressive task-oriented training with the walking aid.
15837366|NCT04145921|Procedure|ERAS for MIS-THA|enhanced recovery after surgery (ERAS) pathway for minimally-invasive surgery of total hip arthroplasty (MIS-THA)
15837367|NCT04145921|Procedure|conventional MIS-THA|conventional pathway for minimally-invasive surgery of total hip arthroplasty (MIS-THA)
15837368|NCT04145908|Procedure|midline mesh reinforcement|augmentation of midline closure by nonabsorbsble mesh
15837369|NCT04145895|Other|Postoperative activity restrictions|Recommendations for return to full activity including return to school, sports, exercise, etc.
15837370|NCT04145882|Procedure|additional osteotomies|varisation osteotomy, supination osteotomy or both
15837371|NCT04145869|Procedure|Cholangiography|All patients will be subjected to intraoperative fluorescent and concommitant X-ray cholangiography
15837372|NCT04145856|Dietary Supplement|I31 probiotic|I31 probiotic formula (dietary supplement), consisting of 3 billion cfus of strains P. acidilactici CECT7483, L.plantarum CECT7484 and L.plantarum CECT7485, once daily (u.i.d)
15837373|NCT04145856|Combination Product|I31 probiotic combined to Alverine/Simethicone|"I31 probiotic formula (dietary supplement), consisting of 3 billion cfus of strains P. acidilactici CECT7483, L.plantarum CECT7484 and L.plantarum CECT7485, once daily (u.i.d)
~Antispasmodic/antifoam drug, consisting of Alverine Citrate 60 mg and Simethicone 300 mg, thrice daily (t.i.d)"
15837374|NCT04145856|Other|Placebo|Placebo treatment (maltodextrin), once daily (u.i.d)
15837375|NCT04145843|Procedure|endoscopic retrograde cholangiopancreatography|ERCP is a procedure that enables the physician to examine the pancreatic and bile ducts and remove gallstones.
15837376|NCT04145830|Device|Ultrasound Cyclo Plasty (UCP)|Cyclocoagulation using High Intensity Focused Ultrasound
15837377|NCT04145817|Genetic|BRIDGES gene panel testing|"The Breast and Ovarian Analysis of Disease Incidence and Carrier Estimation Algorithm-BOADICEAV5/PLUS predicts lifetime and age-specific breast cancer (BC) risks on the basis of family history, all known BC genes test-results, common single nucleotide polymorphisms (SNPs) combined in a PRS, and other non-genetic risk factors. This model is developed within the BRIDGES consortium."
15837378|NCT04145817|Genetic|Breast cancer risk polygenic risk score (PRS)|"The Breast and Ovarian Analysis of Disease Incidence and Carrier Estimation Algorithm-BOADICEAV5/PLUS predicts lifetime and age-specific breast cancer (BC) risks on the basis of family history, all known BC genes test-results, common single nucleotide polymorphisms (SNPs) combined in a PRS, and other non-genetic risk factors. This model is developed within the BRIDGES consortium."
15837379|NCT04145817|Behavioral|Questionnaires|Self-administered questionnaires for counselees to evaluate Psychosocial Aspects of Hereditary Cancer (PAHC), Breast Cancer risk perception adequacy, risk communication within the family and cancer risk management choice,
15837380|NCT04145804|Device|Medtronic Minimed 670G insulin pump|It is an insulin pump to deliver insulin to the patient and associated with a sensor to monitor the glucose levels of the patient. The new feature in this device is the automode algorithm which regulates insulin delivery to the patient automatically to keep glucose levels within target.
15837381|NCT04145791|Other|Ice|ice packs
15837384|NCT04145752|Procedure|Nurse-led femoral nerve block|The nurse perform a femoral nerve block in the emergency department in patients diagnosed with a hip fracture (x-ray)
15837385|NCT04145739|Other|Rehabilitation protocol|The rehabilitation treatment was performer in single session, lasted 60 minutes for session, 2 times a week, carried-out a 6-week exercises program for a total of 12 sessions, by a physiotherapist trained in oncologic rehabilitation, who started with a first phase of at least 15-20 min of low-impact aerobics warm-up. The second phase consisted in diaphragmatic breathing and postural exercises for the midline alignment in a supine position. Finally the patient continued in front of the mirror with exercises for the recovery of shoulder joint, isometric reinforcement exercises for the recovery of strength of shoulder stabilizer muscles. In the presence of lymphedema an additional weekly lymph drainage session was performed for a total of 10 sessions.
15837386|NCT04145713|Dietary Supplement|Probiotic mixture|The experimental intervention will consist in administrating a high-dose multi-strain probiotic (SIVOMIXXTM) for 30 days in addition to hypothermic therapy. The administration of probiotics will begin during the first 24 hours of hypothermia, at the dose of 1 capsule open in 5 millilitre of water. It will be administered daily for 30 days, either via nasogastric tube or orally.
15837387|NCT04145713|Other|Placebo|The comparison intervention will consist in administrating placebo for 30 days in addition to hypothermic therapy. The administration of placebo will begin during the first 24 hours of hypothermia, at the dose of 1 capsule open in 5 millilitre of water. It will be administered daily for 30 days, either via nasogastric tube or orally.
15837391|NCT04145687|Drug|Metformin|Metformin 500mg tid
15837392|NCT04145674|Drug|d-Dextromethadone|Patients will take a total of 2 Tablets (one Tablet from each bottle of the kit), once daily at 6 pm over a period of 10 days
15837393|NCT04145674|Other|Placebo|Patients will take a total of 2 Tablets (one Tablet from each bottle of the kit), once daily at 6 pm over a period of 10 days
15837394|NCT04145661|Device|Hearing aids programmed conventionally.|All participants will wear their hearing aids programmed in this way for around six weeks.
15837395|NCT04145661|Device|Hearing aids programmed with compression activated.|All participants will wear their hearing aids programmed in this way for around six weeks.
15837396|NCT04145635|Device|Aortix System|Aortix is a circulatory support device for chronic heart failure patients on medical management who have been hospitalized for acute decompensated heart failure (ADHF) with worsening renal function.
15837397|NCT04145622|Drug|DS-7300a|A total anti-B7H3 antibody and MAAA-1181a
15837398|NCT04145609|Behavioral|Multidisciplinary team (MDT) care and Acute kidney disease (AKD) clinic|Multidisciplinary team (MDT) care: NPDS care model Acute kidney disease (AKD) clinic: layered approach
15837399|NCT04145596|Drug|HSK3486|HSK3486，Initially 0.4 mg/kg was administered as a 1 minute bolus, followed immediately by a constant infusion dose of 0.4 mg/kg/h administered as a 30 minute infusion via infusion pump.
15837400|NCT04145583|Drug|HSK3486|Sequence 1: Intravenously infuse 0.4 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.
15837401|NCT04145583|Drug|voriconazole +HSK3486|Sequence 2: voriconazole：Day 1,400mg，BID；Day 2--Day 6,200mg，BID；200 mg of voriconazole were taken orally in the morning on an empty stomach of Day 7; followed by 1 min intravenous infusion of 0.4 mg/kg HSK3486 30 min later.
15837402|NCT04145570|Drug|Erlotinib HCl 150 mg|"Concentrations of erlotinib were measured from the samples collected over a 72 hour interval after receiving either Erotinib generic or Tarceva original. Later, after 14 days, a crossover was took place with the same measures.
~dosing in each period."
15837403|NCT04145570|Drug|Tarceva®|Tarceva® 150 mg
15837404|NCT04145557|Device|diode laser 980nm|Procedure: Periodontal therapy with laser Scaling, root planning, oral hygiene instruction and diode laser 980nm treatment of periodontal pockets
15837405|NCT04145557|Device|scaling root planing|scaling and root planing
15837406|NCT04145544|Device|Implantation of the ArtiFascia®|"Following are the general instructions for use for the ArtiFascia®:
~Cut the ArtiFascia® to the required shape under aseptic conditions
~Apply ArtiFascia® to the damaged area
~Suture the ArtiFascia® in place
~Suture bites should be taken 2-3 millimeters from the edges of the implant. Either a running suture or interrupted stitches' technique may be used, depending on clinical conditions or surgeon's decision.
~Important Note: If clinically possible, do not use dural adhesive or sealants as it is an uncontrolled variable, that can influence the results."
15837407|NCT04145544|Device|Implantation of other commercial suturable dural substitute|Implantation of the commercial suturable dural substitute will be according to clinical discretion of the physician, and in compliance with each specific device instructions for use. Detailed instructions are in the instructions for use
15837410|NCT04145518|Drug|Naproxen Sodium|Participants will be randomized to take either a placebo pill or a single 550 mg naproxen sodium pill.
15837411|NCT04145505|Procedure|COLORECTAL CANCER SURGERY|SENTINEL NODE DETECTION
15837412|NCT04145492|Drug|Vitamin K2|Patients will take 90 ug of vitamin K2
15837413|NCT04145492|Drug|Cholecalciferol (inactive vitamin D)|Patients will take 10 ug of vitamin inactive vitamin D
15837414|NCT04145492|Drug|Vitamin K2 and Cholecalciferol|Patients will take 90 ug of vitamin K2 (MK-7) in addition 10 ug of vitamin inactive vitamin D
15837415|NCT04145479|Behavioral|physical activity|exercise
15837416|NCT04145466|Behavioral|High-fat diet|"The high-fat diet will consist of ~40% energy from fat and ~45% from carbohydrates. Protein will be 15% of energy.
~All participants will be assigned an energy intake target that will result in a daily deficit of ~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed"
15837417|NCT04145466|Behavioral|High-carbohydrate diet|"The high-carbohydrate diet will consist of ~20% of energy from fat and ~65% from carbohydrates. Protein will be 15% of energy.
~All participants will be assigned an energy intake target that will result in a daily deficit of ~750 kcal, though no energy intake targets below 1,100 kcal/d (women) and 1,300 kcal/day (men) will be prescribed"
15837600|NCT04144023|Biological|Multi-epitope HER2 Peptide Vaccine H2NVAC|Given intradermally
15837421|NCT04145440|Drug|MOR202|9 doses of MOR202 will be administered as an intravenous infusion over 6 treatment cycles at 28-days each, weekly in C1 and every 4 weeks C2-6.
15837422|NCT04145427|Behavioral|Control|"Initial Weight Loss consultation
~1.5 hour session on how to do implement healthy diet and then have a 2-week follow-up class. Information on how to maintain a healthy combination protein, fat and vegetables daily will be provided provided.
~4 lifestyle coaching sessions
~Monthly visits for behavioral and dietary coaching as well as medication management."
15837423|NCT04145427|Behavioral|LCD|"Initial Weight Loss consultation
~1.5 hour session on how to do implement healthy diet and then have a 2-week follow-up class. Information on how to maintain a LCD will be provided provided.
~4 lifestyle coaching sessions
~Monthly visits for behavioral and dietary coaching as well as medication management."
15837424|NCT04145414|Device|MRI|Reproductiblitity test assessed with MRI for cerebrospinal fluid movements
15837425|NCT04145401|Device|Revision Knee implants|Primary knee arthroplasty or a revision knee that requires a revision procedure.
15837428|NCT04145375|Drug|ZEN003694|Up to 120mg
15837429|NCT04145375|Drug|Enzalutamide|160mg
15837433|NCT04145336|Device|5cm 5-Fr PDS|High-risk patients receive 5cm 5-Fr PDS
15837434|NCT04145336|Device|7cm 5-Fr PDS|High-risk patients receive 7cm 5-Fr PDS
15837435|NCT04145336|Drug|Indomethacin|All patients without contraindications should be administrated with rectal indomethacin within 30 min before ERCP.
15837436|NCT04145323|Diagnostic Test|ICG microangiography|Indocyanine Green (ICG) is a FDA approved dye which preferentially bind to exposed phospholipids in the membranes of necrotic cells, thus acting as a biomarker for necrotic tissue.
15837437|NCT04145310|Drug|BOL-DP-o-04 + SCO|sublingual drops
15837438|NCT04145310|Drug|Placebo + SCO|sublingual drops
15837439|NCT04145297|Drug|Ulixertinib|"Ulixertinib will be provided as 150 mg capsules and will be self-administered twice daily by mouth at the assigned dose level.
~Ulixertinib Dose Level 0 300 mg PO BID, Dose Level 1 (starting dose) 450 mg PO BID, Dose Level 2 600 mg PO BID,
~Medication will be administered in 28-day cycles"
15837440|NCT04145297|Drug|Hydroxychloroquine|Hydroxychloroquine will be provided as 200 mg tablets and will be self-administered by mouth twice daily. Fixed Dose 600mg POBID. Medication will be administered in 28-day cycles
15837441|NCT04145271|Device|Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA)|Resuscitative Endovascular Balloon Occlusion of the Aorta (REBOA) is a minimally invasive damage control procedure for life-threatening abdominal and/or pelvic haemorrhage. It involves temporary occlusion of the aorta with an endovascular balloon, providing proximal control to the site of vascular injury whilst supporting cerebral and myocardial perfusion
15837442|NCT04145258|Drug|Aspirin|Two tablets of aspirin 100 mg per day from inclusion (D-0) to end of Week-8 (W-8)
15837443|NCT04145258|Drug|Placebo of aspirin|Two placebo tablets with the same appearance of aspirin 100 mg per day from inclusion (D-0) to end of Week-8 (W-8)
15837444|NCT04145258|Drug|WHO TBM treatment|2 months of (R-H-Z-E) + 7 months of (R-H)
15837445|NCT04145258|Drug|Intensified TBM treatment|2 months of (HDR-L-H-Z-E) + 7 months of (R-H), with HDR=high-dose rifampicin and L=linezolid
15837446|NCT04145245|Drug|Levocarnitine|Levocarnitine syrup- oral supplementation about 1500 mg/day for 10 weeks
15837447|NCT04145232|Biological|Collection of biopsy (FFPE), blood (PBMC) and stool|Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).
15837448|NCT04145219|Biological|Sublingual allergy immunotherapy tablet|For daily administration (1 tablet per day)
15837449|NCT04145219|Other|Placebo|For daily administration (1 tablet per day)
15837450|NCT04145206|Behavioral|Flamenco dance|evaluation of ankle injuries in the flamenco dancers
15837451|NCT04145193|Drug|Standard of Care - mFOLFOX6|Parts of mFOLFOX6 are: Oxaliplatin 85 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Folinic acid (leucovorin) 400 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Fluorouracil (5-FU) 400 mg/m2 IV bolus on Day 1 then 2,400 mg/m2 over 46 to 48 hours IV infusion Q2W (Day 1-2 of every 14-day cycle).
15837452|NCT04145193|Drug|E1 - mFOLFOX and durvalumab|"Parts of mFOLFOX6 are: Oxaliplatin 85 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Folinic acid (leucovorin) 400 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Fluorouracil (5-FU) 400 mg/m2 IV bolus on Day 1 then 2,400 mg/m2 over 46 to 48 hours IV infusion Q2W (Day 1-2 of every 14-day cycle).
~Durvalumab 1500 mg IV, Q4W (Day 1 of every other 14-day cycle)"
15837453|NCT04145193|Drug|E2 - mFOLFOX6, durvalumab and oleclumab|"Parts of mFOLFOX6 are: Oxaliplatin 85 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Folinic acid (leucovorin) 400 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Fluorouracil (5-FU) 400 mg/m2 IV bolus on Day 1 then 2,400 mg/m2 over 46 to 48 hours IV infusion Q2W (Day 1-2 of every 14-day cycle).
~Durvalumab 1500 mg IV, Q4W (Day 1 of every other 14-day cycle) Oleclumab 3,000 mg IV Q2W x5 then Q4W (Day 1 of every 14-day cycle through cycle 4 then Day 1 of every other 14-day cycle)"
15837454|NCT04145193|Drug|E3 - mFOLFOX6, durvalumab and monalizumab|"Parts of mFOLFOX6 are: Oxaliplatin 85 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Folinic acid (leucovorin) 400 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Fluorouracil (5-FU) 400 mg/m2 IV bolus on Day 1 then 2,400 mg/m2 over 46 to 48 hours IV infusion Q2W (Day 1-2 of every 14-day cycle).
~Durvalumab 1500 mg IV, Q4W (Day 1 of every other 14-day cycle) Monalizumab 750 mg IV, Q2W (Day 1 of every 14-day cycle)"
15837455|NCT04145180|Other|Manual therapy|40 minutes of physiotherapy, based on manual therapy sessions over 6 weeks. Three times a week.
15837456|NCT04145154|Other|Application of platelet rich plasma in chronic wounds of diabetic origin|Application of plasma rich in autologous growht factors after advanced healing
15837457|NCT04145128|Drug|AG881|AG-881 tablets.
15837460|NCT04145102|Other|hesperidine|used for antibacterial and reminerlization assesment
15837461|NCT04145102|Other|propolis|used for antibacterial and reminerlization assesment
15837462|NCT04145102|Other|silver diamine fluoride|used for antibacterial and reminerlization assesment
15837463|NCT04145089|Device|Glidescope video laryngoscopy/ C-MAC video laryngoscopy|usage of said devices according to manual
15837464|NCT04145076|Drug|Placebo|Two oral doses of placebo.
15837465|NCT04145076|Drug|Citalopram|Single oral dose of citalopram (20mg) and single oral dose of placebo.
15837466|NCT04145076|Drug|Tianeptine|Single oral dose of tianeptine (12.5mg) and single oral dose of placebo.
15837467|NCT04145063|Other|no stent|following uretroscopy, no stent will be placed
15837468|NCT04145050|Other|Carbohydrate dosing|The purpose of this study is to examine effects of different carbohydrate doses during marathon simulation in elite wheelchair racers.
15837469|NCT04145037|Drug|AVR-RD-02|AVR-RD-02 Drug product: active substance is autologous CD34+ enriched hematopoietic stem cells (HSCs) that have been genetically modified ex vivo with a lentiviral vector (LV) to contain a ribonucleic acid (RNA) transcript that, after reverse transcription, results in codon-optimized, complementary deoxyribonucleic acid (cDNA) that, upon its integration into human genome, encodes for functional human glucocerebrosidase (GCase).
15837470|NCT04145011|Device|Cooled Radiofrequency|Delivery of energy to ablate sensory nerves via cooled radiofrequency probe (18g, 4mm active tip)
15837471|NCT04145011|Device|Standard Radiofrequency|Delivery of energy to ablate sensory nerves via non-cooled standard radiofrequency probe (22g, curved 10mm active tip)
15837472|NCT04144998|Diagnostic Test|central sensitization inventory (questionnaire)|T.G. Mayer, R. Neblett, H. Cohen, et al. The development and psychometric validation of the central sensitization inventory Pain Pract, 12 (2012), pp. 276-285
15837473|NCT04144985|Other|Visual analog scale (VAS) of pain to evaluate the discomfort participants experience.|Eyelid retraction was performed with one of the three methods (eyelid speculum, unimanual eyelid retraction or cotton tipped applicator assisted eyelid retraction) and participants were then asked to rate their discomfort during the procedure with a visual analog scale (VAS) of pain.
15837474|NCT04144972|Device|Medtronic Summit RC+S|The investigators will perform DBS versus sham (randomized) to evaluate efficacy of stimulation for analgesia. Closed-loop DBS will be compared to open-loop DBS in a patient blinded, randomized fashion after initial, efficacy evaluation.
15837475|NCT04144959|Device|Indigo Aspiration System|Indigo Aspiration System
15837476|NCT04144933|Drug|Acetaminophen, Gabapentin|975 mg, 300 mg
15837477|NCT04144933|Drug|Acetaminophen, Gabapentin|975 mg, 300 mg
15837478|NCT04144933|Drug|Lidocaine 1% Injectable Solution, Dexmedetomidine, Ketamine|1.5 mg/kg, 0.5 mcg/kg, 0.5 mg/kg
15837479|NCT04144933|Drug|Dexamethasone, Ondansetron|6 mg, 4 mg
15837480|NCT04144933|Drug|Sevoflurane, Lidocaine 2% Injectable Solution, Ketamine, Dexmedetomidine, Magnesium Sulfate|Dose titrated to effect, 1.5 mg/kg/hr, 0.15 mg/kg/hr, 0.3 -1 mcg/kg/hr (titrated to effect), 30 mg/kg bolus over 30 minutes
15837481|NCT04144933|Drug|Lidocaine 1% Injectable Solution, Sufentanil|0.5 mg/kg, 0.25-0.5 mcg/kg (titrated to effect)
15837482|NCT04144933|Drug|Sevoflurane, Sufentanil|Dose titrated to effect, As needed (dose at anesthesiologist's discretion)
15837483|NCT04144920|Behavioral|CS: Continuous sitting|Participants were asked to sit continuously throughout the duration of the lab visit.
15837484|NCT04144920|Behavioral|HFLD: HIgh frequency, low duration standing breaks|Participants were asked to interrupt their sitting time every 15 minutes using 2.5-minute standing breaks.
15837485|NCT04144920|Behavioral|LFHD: Low frequency, high duration standing breaks|Participants were asked to interrupt their sitting time every 60 minutes using 10-minute standing breaks.
15837486|NCT04144907|Dietary Supplement|Phenylalanine intake|Oral consumption of eight hourly experimental meals- Includes 4 tracer-free experimental meals containing a mixture of free amino acids, calories from a flavored liquid and protein-free cookies and 4 labeled amino acid experimental meals.
15837487|NCT04144894|Diagnostic Test|Shear Wave Elastography|Advanced ultrasound technique
15837488|NCT04144881|Diagnostic Test|coronary computed tomography|patients randomized in this arm will perform computed coronary tomography 6 months after the index percutaneous revascularization on unprotected left main artery
15837489|NCT04144868|Other|Normobaric Oxygen|
15837490|NCT04144855|Drug|TQB3474 injection|This is a kind of heat shock protein (HSP90) inhibitor.
15837491|NCT04144842|Biological|ATOR-1017|ATOR-1017 is a human monoclonal antibody targeting 4-1BB (CD137)
15837492|NCT04144829|Procedure|HIFU|Intravaginal HIFU procedure, lengths 1.5, 3 and 4.5 mm - 200, 200 and 100 impulses respectively
15837493|NCT04144829|Procedure|Fibrin|Injection of 2ml platelet-rich fibrin from centrifuged for 5 min patient's blood under the urethra
15837494|NCT04144816|Other|Not applicable (no intervention)|Not applicable (no intervention)
15837495|NCT04144803|Diagnostic Test|Cerebral near-infrared spectroscopy|Nonin H500 one-channel near-infrared spectroscopy monitor on forehead of the patient from before induction of anesthesia to arrival to hospital
15837496|NCT04144790|Dietary Supplement|ferrous sulfate|Although established guidelines do not currently exist for iron supplementation for children, studies have demonstrated effectiveness of a 3-month treatment regimen of 5mg/kg per day of orally-administered ferrous sulfate in reducing PLMS and subjective RLS symptoms and in increasing serum ferritin levels. Ferrous sulfate 80 mg/day resulted in improvement of ADHD symptoms in iron-deficient children.
15837497|NCT04144777|Dietary Supplement|Solarplast|Subjects will take one capsule of Solarplast (100mg) daily for 45 days.
15837555|NCT04144283|Behavioral|NAP|"For experiment 1, the NAP group will undergo a post-learning 2-hour diurnal sleep opportunity (i.e. 'nap') without cues.
~For experiment 2 the NAP+TMR group will undergo a post-learning 2-hour diurnal sleep opportunity (i.e. 'nap') with auditory TMR. The learning related sounds will be presented to participants at 140% of their minimal auditory detection threshold during stage 2 and stage 3 of NREM sleep."
15837498|NCT04144764|Other|Workplace-based exercise|Participants will have to perform 10-week of workplace-based exercise programme which consist of 5 sessions of 10 minutes per week. The workplace-based exercise programme will consist of general stretching and strengthening exercise using resistance tubing for both the neck and upper limb. Specific rotator cuff and scapular muscles strengthening exercise were also included to enhance glenohumeral and scapular kinematics (Appendix). Each participant will receive a set of elastic resistance tubing that comprise red (2kg), green (3kg) and blue (4kg). The exercise programme will be taught by physiotherapist during their baseline assessment. They will be asked to train at the workplace during workdays (Monday to Friday), five times a week during the 10-week intervention. The program built on the principle of progressive overload.
15837499|NCT04144764|Other|Ergonomic advice and education|Participants will receive ergonomic training and education on how to adjust their workstations to reduce the ergonomic risk factors when using computers.
15837500|NCT04144751|Other|Blood Sample Collection|Subjects participating in the study will have blood drawn at enrollment.
15837501|NCT04144738|Diagnostic Test|mt-sDNA 2.0 screening test|Stool samples will be collected by the subject for the mt-sDNA screening test.
15837502|NCT04144738|Diagnostic Test|FIT test|Stool samples will be collected by the subject for the FIT test.
15837503|NCT04144738|Procedure|Colonoscopy|Subjects will undergo a screening colonoscopy.
15837504|NCT04144712|Drug|Caffeine Citrate|study rate of occurrence of Apnea of Prematurity between the 2 groups
15837505|NCT04144686|Other|Physiotherapy Rehabilitation|Participants will be randomly allocated, using a random number generator, to a 12-week supervised customised exercise group incorporating VRT programme without (Group A) or with cognitive DT exercises (Group B).
15837506|NCT04144673|Other|Silver Hydrosol|Silver quantity will be 7 doses per day, with 50 mcg per dose.
15837507|NCT04144673|Other|Placebo|Placebo water with no active ingredients
15837508|NCT04144660|Device|Extracorporeal Membrane Oxygenation|Use of ECMO for circulatory / hemodynamic support of peripartum of pregnant patients who developed cardiogenic shock.
15837509|NCT04144647|Other|Single testing session|"All participants that meet the inclusion criteria, will have to attend the research laboratory at Centre for Human and Applied Physiological Sciences, Shepherd's House, Guy's Campus, King's College London, SE1 1UL to be assessed in a single testing session.
~The testing session will require them to complete some questionnaires regarding balance confidence, psychological state, sleep and physical function and to undertake some simple tests of cognitive function. They will also undertake a brief dynamic balance assessment and the dual-task gait test. The dual-task component involves two cognitive tasks (a numeracy and a literacy task) or auditory task. The gait test will be performed separately and then together with each of two cognitive tasks or auditory task.
~On the day, after the testing, each participant will, also, be provided a physical activity monitor (accelerometer-AX3) to wear on their wrist for 24 hours a day, seven days a week without taking it off."
15837510|NCT04144634|Other|Strengthening exercises|The intervention group will receive 2 supervised exercise sessions a day. The exercise consists of progressive resistance training based around the movement of standing up/sitting down.
15837511|NCT04144634|Other|Stretching exercises|The intervention group will receive 2 supervised exercise sessions a day. The exercise consists of gentle stretching of upper limbs and lower limbs.
15837512|NCT04144621|Procedure|ICSI|Intracytoplasmic sperm injection of female partner oocytes with ejaculated sperm selected by density gradient centrifugation
15837513|NCT04144608|Drug|treprilumab combination with platinum-containing dual-drug chemotherapy|Nab-paclitaxel/pem +cisplatin +PD-1(Nab-paclitaxel260mg/m2 D1 Cisplatin 75mg/m2 D1 or carboplatin,determined by the investigator AUC)PD-1 200mg D1
15837514|NCT04144595|Diagnostic Test|2 hour 75 g Oral glucose tolerance test|In pregnant women between 24 and 34 weeks of gestational age, plasma glucose was recorded after an overnight fast. Following consumption of 75 g glucose in 200 mL water over 10 min, the equivalent 1 hour and 2 hour values was recorded
15837515|NCT04144582|Drug|Sintilimab Combined With Docetaxel Monotherapy|Sintilimab 200mg i.v q3w , Docetaxel 75mg/m2 i.v q3w
15837516|NCT04144569|Drug|PD-1 Combined With Pyrotinib|PD-1 Combined With Pyrotinib
15837517|NCT04144556|Other|Nintendo Wii and conventional physical therapy|"This group of patients will receive, in addition to the exercise program described below, a virtual rehabilitation program through Nintendo Wii. This program will include upper limb training and lower limb balance training. Participants will choose the games they want to perform the session with. Wii Fit (balance games) will be used for the treatment of the lower limbs, and Wii Sports (bowling, golf and tennis games) will be used for the treatment of the upper limbs."
15837518|NCT04144556|Other|Conventional Physical therapy|A warm-up period using a stationary bicycle, mobility exercises in supine position, active-assisted/passive kinesiotherapy of the lower and upper limbs, strengthening exercises in sitting position, balance, stability and coordination exercises and walking re-education exercises.
15837519|NCT04144543|Other|White Noise|The white noise was initiated 50 cm away from the baby, with the decibel meter set to an average of 55 decibels. The baby was exposed to white noise for 2 minutes before the procedure.
15837520|NCT04144543|Other|Facilitated Tucking|The baby's arms and legs were held in flexed positions close to the midline of the torso in sidelying position, so the baby was able to move his/her extremities. The baby was held in facilitated tucking position for one minute before the procedure.
15837521|NCT04144543|Other|White Noise+Facilitated Tucking|The baby was exposed to white noise for 1 minute before the procedure. The white noise was initiated 50 cm away from the baby, with the decibel meter set to an average of 55 decibels. At the second minute, when the white noise still continued to play, facilitated tucking was performed at the same time and the baby continued to listen to the white noise for 1 minute while in facilitated tucking position.
15837524|NCT04144504|Device|Retrievable metallic stenting|Use of retrievable metallic stents for the treatment of biliary anastomotic stricture after liver transplantation
15837525|NCT04144504|Device|Plastic stenting|Use of plastic stents
15837556|NCT04144283|Behavioral|WAKE|For experiment 1, the WAKE group will undergo a post-learning 2-hour period of quiescent wakefulness without cues.
15837601|NCT04144023|Procedure|Therapeutic Conventional Surgery|Undergo standard of care surgery
15837526|NCT04144491|Dietary Supplement|Probiotic|"Probiotics are defined by the Food and Agricultural Organization (FAO)/WHO as live microorganisms, which when consumed in adequate amounts, confer a health benefit on the host. Lactobacillus rhamnosus GG (LGG) is the most documented probiotic bacteria, with many proven unique characteristics and therewith associated health benefits. No adverse effects of the consumption of LGG in healthy infants have been reported. The Lactobacillus rhamnosus yoba containing yoghurt drink, which is locally produced and subsequently consumed by resource-poor communities in rural Uganda has been described. The strain used in this intervention is a generic variant of LGG, called Lactobacillus rhamnosus yoba 2012. LGG is consumed as part of food all over the world, and is not a drug.
~100ml of yoghurt containing Lactobacillus rhamnosus yoba 2012 will be consumed 5 days per week, for 9 weeks."
15837527|NCT04144491|Dietary Supplement|Placebo|100ml of custard will be consumed 5 days per week, for 9 weeks.
15837528|NCT04144478|Other|Web based education|Web based education
15837529|NCT04144465|Drug|NORADRENALIN|DRUG THAT IS IMPROVING TISSUE AND ORGAN PERFUSION
15837530|NCT04144465|Drug|PHENYLEPHRINE|DRUG THAT IS IMPROVING TISSUE AND ORGAN PERFUSION
15837531|NCT04144452|Other|Patient Education Session|The intervention of Patient Education will be designed individually according to the patient's need who have undergone lumbar microdiscectomy procedure through MIS. The basic purpose of the educational session will be to inform the participants about their pre operative and current back condition and discuss methods to care for their back. The session will be given for one hour and face to face interaction will be ensured twice a week. Initially the post operative education plan and instructions will be formulated, reviewed and finalized by the operating surgeon.
15837532|NCT04144452|Other|Therapeutic Exercise plus educational session|Therapeutic exercises include strength and endurance training and mat exercises. Strengthening exercises of the trunk extensors will be initiated first and then endurance exercises will be targeted. Mat exercises will be performed to strengthen the back and lower musculature. Treatment will be given twice a week for almost three months. Individualized educational sessions will be performed in the same way as conducted in the other group. Progression of the exercises and the rest periods will be incorporated according to the status of patient.
15837533|NCT04144439|Drug|GABA|Gamma amino butyric acid
15837534|NCT04144426|Behavioral|Normal diet|Participants will receive either a 2000 calorie or a 2500 calorie diet at normal meal times
15837535|NCT04144426|Behavioral|Modified diet|Participants will receive either a 2000 calorie or a 2500 calorie diet with a single meal shift, breakfast is moved to an hour before bedtime.
15837536|NCT04144413|Drug|Open-label Ikervis|NOVA22007, IKERVIS® is a sterile, ophthalmic cationic oil-in-water emulsion containing 1mg/ml CsA.
15837537|NCT04144413|Drug|Masked Ikervis|NOVA22007, IKERVIS® is a sterile, ophthalmic cationic oil-in-water emulsion containing 1mg/ml CsA.
15837538|NCT04144413|Other|Vehicle Comparator: Masked Vehicle|Vehicle of IKERVIS® - sterile, ophthalmic cationic oil-in-water emulsion containing no active substance.
15837539|NCT04144400|Behavioral|Direction Check App|Direction Check is a simple, inexpensive app that builds resilience through balanced values to target the everyday personal and occupational stressors faced by military populations.
15837540|NCT04144400|Behavioral|Direction Check App (Time Management Version)|Direction Check (Time Management Version) is a simple, inexpensive app that builds resilience through time management exercises to target the everyday personal and occupational stressors faced by military populations.
15837541|NCT04144387|Procedure|Myelogram|Two additional myelograms will be performed comparing to standard of care.
15837542|NCT04144374|Drug|Omadacycline|Omadacycline will be administered 200 mg IV once daily on day 1 followed by omadacycline 300 mg by mouth once daily for 2-4 doses.
15837543|NCT04144374|Procedure|Microdialysis Catheter Insertion|A 20 kilodalton microdialysis probe (63 MD catheter; MDialysis Inc., N. Chelmsford, MA) will be inserted into the subcutaneous tissue at the margin of the wound (patient group) or in the thigh tissue (healthy volunteers). The probe will be left in place for the final dose and all tissue sampling procedures thereafter. This probe is perfused with a physiologic solution to collect interstitial fluid samples. The probe will then be removed after completion of sample collection.
15837544|NCT04144361|Procedure|sleeve with plication|sleeve with plication
15837545|NCT04144361|Procedure|sleeve without plication|sleeve without plication
15837546|NCT04144348|Biological|mRNA-1653|sterile liquid for injection
15837547|NCT04144348|Biological|Placebo|sterile liquid for injection
15837548|NCT04144335|Biological|N-803 and bNAbs|Treatment will consist of N-803, VRC07-523LS, PGT121, and haNK, with N-803 given for 3 cycles of 9 weeks/cycle. N-803 will be given every 3 weeks (3 doses/cycle) and bNAbs will be given every 9 weeks.
15837549|NCT04144335|Biological|haNK™ Cells|Treatment will consist of N-803, VRC07-523LS, PGT121, and haNK, with N-803 given for 3 cycles of 9 weeks/cycle. N-803 will be given every 3 weeks (3 doses/cycle), bNAbs will be given every 9 weeks, and haNK cells administered on the same day as each infusion of N-803.
15837550|NCT04144322|Device|Zimmer T3 Short Ex Hex With Discrete Crystalline Deposition|Placement of a short implant
15837551|NCT04144322|Device|Zimmer T3 with DCD Ex Hex Parallel Walled implants|Placement of a long implant with sinus lift and bone graft
15837552|NCT04144309|Procedure|Electroacupuncture (EA) and Auricular Acupressure (AA)|"EA: Ten points will be used, including GV24 (Shenting), GV20 (Baihui), EX-HN1 (Sishenchong), PC6 (Neiguan), CV12 (Zhongwan), CV4 (Guanyuan), ST25 (Tianshu), ST36 (Zusanli), SP6 (Sanyinjiao), KI3 (Taixi).
~AA: Vaccaria seeds will be embedded by acupuncturists on three auricular points (Shenmen, Sympathetic and Heart) and maintained between EA treatments."
15837553|NCT04144309|Procedure|Sham Electroacupuncture (SE) and Sham Auricular Acupressure (SA)|"SE: The sham acupuncture treatment procedure, including the acupoint selection principle, sterilization procedure and treatment schedule, will be the same as in the acupuncture treatment group, except that sham points 1 to 2 cm exterior and inferior to the real points will be used, and no needle penetration or electric stimulation will be performed.
~SA: Three sham auricular points in the helix region (HX7, HX8, HX9) will be selected. Instead of Vaccaria seeds, soft Junci Medulla (1 to 2 mm in length, dyed black) will be used to mimic real AA with no pressure."
15837554|NCT04144296|Diagnostic Test|Study procedure|"Measurement of the flow rate of supplemental oxygen
~Measurement of the peripheral arterial saturation (SpO2) by pulse oximetry
~Taking of an ABG sample (ABG1) from the arterial line
~Taking of capillary blood gas analysis from the earlobe and from the finger tip
~Taking of an a second ABG (ABG2) from the arterial line"
15837557|NCT04144270|Other|Evaluation of muscle mass and muscle function|Included patients have their muscle mass and muscle function evaluated before start on and after completion of oncological treatment.
15837558|NCT04144257|Drug|[F-18]PBR06|PET radiopharmaceutical. Subjects will undergo [F-18]PBR06-PET (microglial activation).
15837559|NCT04144257|Drug|[C-11]Methylreboxetine|PET radiopharmaceutical. Subjects will undergo [C-11]MRB-PET (norepinephrine transporter binding).
15837560|NCT04144244|Other|MicroFluidic Sperm Sorting Chips|sperm selection of IUI treatment
15837561|NCT04144244|Other|Gradient-Density Centrifugation|sperm selection of IUI treatment
15837562|NCT04144231|Behavioral|iCBT-I|Internet-Based Cognitive Behavioral Therapy for Insomnia (ICBT-I) with the support of a therapist, delivered by mobile application (HUS iCBT-I)
15837563|NCT04144231|Behavioral|GCBT-I|Cognitive Behavioral Group Therapy for Insomnia (GCBT-I)
15837564|NCT04144218|Drug|Lacosamide|The experimental group will be given oral lacosamide supplementation on the basis of the original antiepileptic drugs.
15837565|NCT04144218|Drug|Placebo oral tablet|The control group will be given oral placebo supplementation on the basis of the original antiepileptic drugs.
15837566|NCT04144205|Other|Change of the fraction of inspired oxygen|"After the stabilization of cardiopulmonary bypass, in the first half of patients, fraction of inspired oxygen would be set at 0.5 and maintained for 5 minutes (T0), then it would be changed to 1.0 and maintained for 5 minutes (T1). Again, fraction of inspired oxygen would be resumed to be 0.5 and maintained for 5 minutes (T2).
~In the other half of patients, the direction of change in fraction of inspired oxygen will be reversed as follows. It will be set at 1.0 and maintained for 5 minutes (T0), then changed to 0.5 and maintained for 5 minutes (T1), and finally to 1.0 and maintained for 5 minutes (T2)."
15837567|NCT04144192|Drug|Lidocaine patch 1.8%|
15837568|NCT04144192|Drug|Lidocaine 5% patch|
15837569|NCT04144192|Drug|Lidocaine 2% Injectable Solution|
15837570|NCT04144179|Biological|Quadrivalent RIV with H3 strain 1|Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular
15837571|NCT04144179|Biological|Quadrivalent RIV with H3 strain 2|Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular
15837572|NCT04144179|Biological|Quadrivalent RIV with H3 strain 3|Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular
15837573|NCT04144179|Biological|Quadrivalent RIV with H3 strain 4|Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular
15837574|NCT04144179|Biological|Quadrivalent RIV with 2018-2019 NH H3 strain|Pharmaceutical form: Pre-filled single-dose vial Route of administration: Intramuscular
15837575|NCT04144166|Device|capillary refill index (CRI)|a waveform analysis method using a pulse oximeter to assess peripheral perfusion
15837576|NCT04144153|Combination Product|Opioid Free Total Intravenous Anesthesia|Total intravenous anesthesia with propofol and dexmedetomidine hydrochloride and ketamine hydrochloride
15837577|NCT04144153|Combination Product|Total Intravenous anesthesia with opioid|Total Intravenous anesthesia with opioid
15837579|NCT04144127|Behavioral|Soccer|"Soccer drills and other fitness routines (two 1-hour sessions per week)
~In person education in Life's Simple 7 to help improve life through Lifestyle changes: smoking status, physical activity, weight, diet, blood glucose, cholesterol, and blood pressure."
15837580|NCT04144127|Behavioral|mHealth|It is an online platform is accessible on a smartphone application (IOS or Android) or desktop, to help patients monitor their physical activity (PA) data weekly and receive messages for behavior change support and reminders for data synchronization. The study team will send two short text messages twice weekly: one message will be focused on a weekly goal for minutes of moderate-to-vigorous PA; and the second will be based on one of the AHA's Life's Simple 7, including lifestyle messages so the participants can improve through lifestyle changes, helping to achieve ideal cardiovascular health.
15837581|NCT04144114|Dietary Supplement|ProHydrolase®|Subjects received 250mg of ProHydrolase® with 25g whey protein mixed together in a drink
15837582|NCT04144114|Dietary Supplement|Whey protein|Subjects received 25g of whey protein powder mixed to together in a drink
15837583|NCT04144114|Dietary Supplement|Placebo|Placebo
15837584|NCT04144101|Drug|Etoricoxib|Etoricoxib 60 mg QD Oral
15837585|NCT04144101|Drug|Aceclofenac|Aceclofenac 100 mg BID Oral
15837586|NCT04144088|Drug|Wu Ling San|assigned to Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Wu Ling San for a period of 4 weeks.
15837587|NCT04144088|Drug|Yin-Chen Wu Ling San|assigned to Yin-Chen Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Yin-Chen Wu Ling San for a period of 4 weeks.
15837588|NCT04144088|Drug|Placebo|1/10 Wu Ling San assigned to Placebo (n =20) and were instructed to take 4.5 gm 2 times per day of Placebo for a period of 4 weeks.
15837589|NCT04144075|Behavioral|Mindful Self-Compassion Program|It is a protocolized training program in mindfulness and self-compassion skills. It has a duration of 8 weekly group sessions of about two hours and 45 minutes and a silent retreat of 4 hours.
15837590|NCT04144075|Behavioral|Cognitive Behaviour Therapy Group|It is a control intervention designed for the development of a control group suitable for comparison with experimental groups.
15837591|NCT04144075|Other|Treatment as usual|It is variable according to the clinical and personal characteristics of the patient, the most common components will be described.
15837592|NCT04144062|Other|CAD/CAM crowns|CAD/CAM crowns
15837593|NCT04144049|Drug|MT921|Subcutaneously administered, 0.2ml per injection, at most 50 injections per treatment session.
15837594|NCT04144049|Drug|Placebo|Subcutaneously administered, 0.2ml per injection, at most 50 injections per treatment session.
15837595|NCT04144036|Biological|Neihulizumab, 3 mg/kg|The doses for the 3 + 3 design (dose escalation phase) are listed in the arm description. The dose-expansion phase will use the maximum-tolerated dose.
15837596|NCT04144036|Drug|Neihulizumab, 6 mg/kg|The doses for the 3 + 3 design (dose escalation phase) are listed in the arm description. The dose-expansion phase will use the maximum-tolerated dose.
15837597|NCT04144036|Drug|Neihulizumab, 9 mg/kg|The doses for the 3 + 3 design (dose escalation phase) are listed in the arm description. The dose-expansion phase will use the maximum-tolerated dose.
15837598|NCT04144036|Drug|Neihulizumab|This arm will receive the Maximum Tolerated Dose determined in the Drug Escalation phase.
15837602|NCT04143997|Diagnostic Test|A clinical Transthoracic echocardiogram|A previously clinically completed transthoracic echocardiogram will be utilized to assess for diastolic dysfunction in the presence of normal systolic function for patients with previously diagnosed peripartum cardiomyopathy.
15837603|NCT04143984|Drug|Induction chemotherapy|Induction chemotherapy with the regimen of gemcitabine plus nedaplatin.
15837604|NCT04143984|Radiation|Carbon-ion radiotherapy|Accelerated carbon-ion beam with pencil beam scanning technique.
15837605|NCT04143984|Drug|Camrelizumab|An anti-PD-1 antibody.
15837606|NCT04143971|Other|intermittent fasting diet|intermittent fasting diet
15837607|NCT04143971|Other|low calorie diet|continuous low calorie diet
15837608|NCT04143958|Drug|agalsidase beta (GZ419828)|Pharmaceutical form:Powder for concentrate for solution for infusion Route of administration: Intravenous (IV) infusion,
15837609|NCT04143958|Drug|agalsidase alfa|Pharmaceutical form:concentrate for solution for infusion Route of administration: Intravenous (IV) infusion
15837610|NCT04143945|Drug|Semaglutide (administered by DV3396 pen)|Subjects will receive 1 single dose of semaglutide 0.25 mg on 1 day
15837611|NCT04143945|Drug|Semaglutide (administered by PDS290 pen)|Subjects will receive 1 single dose of semaglutide 0.25 mg on 1 day
15837612|NCT04143919|Diagnostic Test|NYHA assessment|The New York Heart Association (NYHA) functional classification of HF
15837613|NCT04143919|Procedure|Serum NT-proBNP concentration|Subjects with NYHA score ≥ II will undergo a rapid, on site serum NT-proBNP test on the same day of the visit. Roche CARDIAC proBNP+ test, using the Cobas h 232 device, is a quantitative immunological test for the determination of NT-proBNP in heparinized venous blood.
15837614|NCT04143919|Diagnostic Test|Transthoracic Ecocardiogram|Subjects with a serum NT-proBNP result of ≥ 125 pg/mL at Visit 1 will be referred to a study cardiologist for a transthoracic echocardiogram to assess LVEF and relevant structural heart disease
15837615|NCT04143906|Drug|Vinorelbine|injection
15837616|NCT04143906|Drug|Gemcitabine|injection
15837617|NCT04143906|Drug|Carboplatin|injection
15837618|NCT04143893|Device|Mechanical circulatory support|Patients with cardiogenic shock who underwent MCS
15837619|NCT04143893|Drug|Optimal medical treatment|Patients with cardiogenic shock who received optimal medical treatment including vasopressor
15837620|NCT04143880|Drug|Progesterone|intramuscular injection intranasal administration
15837621|NCT04143880|Other|saline|intramuscular injection intranasal administration
15837622|NCT04143867|Device|Nolix Device|For temporary management of SUI
15837623|NCT04143854|Drug|MBA-P01(Botulinum toxin A)|Intramuscular injection; Dose varies by group
15837624|NCT04143854|Drug|Placebo|Intramuscular injection; normal saline
15837625|NCT04143841|Device|Viveye OMNS treatment|The Viveye OMNS treatment ( ~30 min) will be applied once, during the treatment visit only
15837626|NCT04143841|Device|Viveye OMNS sham treatment|The Viveye OMNS sham treatment ( ~30 min) will be applied once, during the treatment visit only
15837627|NCT04143828|Behavioral|mobile mindfulness programme|"The mobile mindfulness programme adheres to a standardized protocol developed from the MBSR curriculum (Kabat-Zinn, 1990). The program consists of six modules. Each module consists of a short movie (talking head) explaining the content and two audiofiles to guide experiential mindfulness meditation exercises. Participants can follow the different modules based on their own time-schedule.
~Key objectives are: (1) to increase awareness of one's present moment experience; (2) to teach an attitude of openness and acceptance (non-judging) toward one's experience."
15837628|NCT04143815|Drug|MBA-P01 (Botulinum toxin A)|Intramuscular injection, dose varies by groups
15837629|NCT04143815|Drug|Placebo|Intramuscular injection
15837630|NCT04143802|Drug|LY3437943|Administered SC
15837631|NCT04143802|Drug|Dulaglutide|Administered SC
15837632|NCT04143802|Drug|Placebo|Administered SC
15837633|NCT04143789|Drug|AP-002|Dose escalation
15837634|NCT04143776|Procedure|Abdominal reconstruction|No restrictions are set on surgical procedures or anaesthetic management.
15837635|NCT04143763|Other|Ecological Momentary Intervention (EMI)|Using the messaging function of mobile devices, EMI offers a framework to deliver health information to the target population, corresponding to each individual's demands in terms of type (e.g., photo, text and/or voice message), timing, duration, and frequency of the messages, which are different to the features from other interventions
15837636|NCT04143750|Drug|[14C]Vicagrel|Take a suspension of 20 mg vicagrel ,containing about 120 μCi [14C]Vicagrel, in fasting within 5 minutes
15837637|NCT04143737|Behavioral|Healthy lifestyle intervention|38 women participated in the intervention group which was located in a community center in Zur-Baher neighborhood. The intervention consisted of 20 weekly sessions on nutrition, physical activity, stress management skills, and self-monitoring. All taught by professional facilitators (nutritionists, exercise trainers, health coaches, and psychotherapists). Baseline data was collected
15837638|NCT04143724|Drug|ACE-536|Up to 6 participants will start with luspatercept at 0.75mg/kg and the Dose Review Team (DRT) will evaluate all toxicities of each participant after Cycle 1 and determine whether or not to enroll the next cohort at the next planned dose level
15837639|NCT04143724|Drug|ACE-536|Up to 6 participants will start with luspatercept at 1.0mg/kg and the Dose review team (DRT) will evaluate all toxicities of each participant after Cycle 1 and determine whether or not to enroll the next cohort (Expansion Cohort)
15837640|NCT04143724|Drug|ACE-536|Up to 30 participants will start with luspatercept (at the Recommended Dose (RD) determined by the Dose Review Team (DRT)). Overall safety data from all cohorts in part A (Cohorts 1, 2 & 3) will be assessed before Part B (Cohorts 4 & 5) can be initiated
15837641|NCT04143724|Drug|ACE-536|Up to 6 participants will start with luspatercept at 1.0mg/kg and the Dose Review Team (DRT) will evaluate all toxicities of each participant after Cycle 1 and determine whether or not to enroll the next cohort at the next planned dose level
15837642|NCT04143724|Drug|ACE-536|Up to 6 participants will start with luspatercept at 1.25 mg/kg and the Dose Review Team (DRT) will evaluate all toxicities of each participant after Cycle 1.
15837643|NCT04143711|Drug|DF1001|Immunotherapy agent targeting NK cells.
15837644|NCT04143711|Drug|Nivolumab|Anti-PD-1 immunotherapy agent
15837645|NCT04143711|Drug|Nab paclitaxel|A chemotherapy treatment combining paclitaxel with albumin
15837646|NCT04143698|Device|endoscopic retrograde cholangiopancreatography|The duodenoscope will be passed to the duodenum in the standard fashion. Once the papilla has been identified in the duodenum, cannulation of the desired duct will be performed in the standard fashion, with the type of accessories used left to the discretion of the individual endoscopist performing the procedure. If cannulation is considered difficult, advanced cannulation techniques can be used per standard of care at the discretion of the individual endoscopist. The types of accessories used will be left to the discretion of the individual endoscopist and will be dependent on procedure indication and personal preference. Cross-over to the alternate duodenoscope type can be performed at any time if the desired technical maneuver cannot be performed with the designated duodenoscope.
15837647|NCT04143685|Drug|Misoprostol|Oral administration of cytotec every 4 hours until a maximum of 6 doses
15837648|NCT04143685|Drug|Oxytocin|Intravenous infusion of Pitocin through an IVAC until delivery
15837649|NCT04143672|Device|Electronic digital pressure algometer|"Evaluation of pain threshold using an algometer is conducted one day before surgery.
~The pressure of the plunger of algometer is applied vertically to the patient's right thenar muscle belly at a speed of 10 N/sec by the tester. Then the tester removes the algometer when the patients start to feel pain and record the pressure recorded on the algometer."
15837650|NCT04143672|Diagnostic Test|Pain sensitivity questionnaire|Evaluation of pain threshold using the Korean-version pain sensitivity questionnaire is conducted one day before surgery.
15837651|NCT04143659|Biological|levonorgestrel butanoate (LB) injection|"The initial formulation of the investigational product (IP) is LB Injectable Suspension at a concentration of 40 mg/2 mL (20 mg/mL). Each vial contains 2 mL at 20mg/mL for a total of 40 mg. This formulation will only be used for dosing groups A and B with the injections completed as 40 mg IM (2 mL) or 40 mg SQ (2 mL).
~The second formulation of the investigational product (IP) is LB Injectable Suspension is a concentration of 140 mg/2 mL (70 mg/mL). Each vial contains 2 mL at 70 mg/mL for a total of 140 mg. This formulation will only be used for dosing groups B2, C and D with the injections completed as 40 mg SC (0.57 mL), 80 mg IM (1.14 ml), and 80 mg SQ (1.14 mL)."
15837652|NCT04143646|Behavioral|Web-based prevention program|"Telemetric control of risk factors, e-learning, contacts by e-mails/apps. If no response telephone calls.
~In a substudy evaluation of disclosure of genetic risk."
15837653|NCT04143633|Other|Low FODMAP diet|The diet will be in accordance to the baseline energy expenditure calculated by Harris-Benedict whit 55% of carbohydrates, 25% of lipids and 20% of proteins, divided in five meals. The distribution of carbohydrates depends on the content of fodmaps on each food.
15837654|NCT04143633|Other|Standard diet|The diet will be in accordance to the baseline energy expenditure calculated by Harris-Benedict whit 55% of carbohydrates, 25% of lipids and 20% of proteins, divided in five meals. Cruciferous vegetables, fruits and condiments will be eliminated and a normal content of fodmap.
15837655|NCT04143620|Procedure|Procedure|Triple procedure
15837656|NCT04143607|Drug|ASK120067|The initial dose of ASK120067 160 mg twice daily can be reduced to 80 mg twice daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
15837657|NCT04143607|Drug|Placebo Gefitinib 250 mg|The initial dose of Placebo Gefitinib 250 mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
15837658|NCT04143607|Drug|Gefitinib|Gefitinib (250 mg orally, once daily) , in accordance with the randomization schedule. Following objective disease progression according to RECIST1.1, as per investigator assessment, patients who were randomized to Standard of Care arm may have the option to receive open-label ASK120067 (crossover to active ASK120067).
15837659|NCT04143607|Drug|Placebo ASK120067|The initial dose of Placebo ASK120067 160 mg once daily can be reduced to Placebo ASK120067 80 mg twice daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
15837666|NCT04143581|Drug|Empagliflozin 10 MG|Empagliflozin 10 mg/die for 28 days
15837667|NCT04143568|Other|Observation|Evaluation of endothelial progenitor cells level and correlation of endothelial progenitor cells level with periodontal and cardiovascular disease
15837668|NCT04143555|Procedure|endoscopic submucosal injection of indocyanine green before laparoscopic gastrectomy|Indocyanine green was injected under endoscope within 24 hours before operation. Four points(0.5ml/point,1.25mg/ml) were evenly injected in four quadrants at the edge of the tumor. The injection method was direct submucosal injection and 0.5ml saline + 0.5ml indocyanine green solution + 0.5ml saline (sandwich method). The imaging effect was evaluated by indocyanine green fluorescence imaging system during the operation. The effect was divided into grade0 and Grade1. Grade1: The imaging of the tumor and the corresponding lymphatic drainage area in the injection area both were ideal. Grade 0: not up to grade 1, classified into tumor body and drainage area without imaging, only tumor body imaging, and even though tumor body and regional lymph drainage area imaging, the contrast agent in the gastric wall was too diffuse or even overflowing, which seriously interfered with the observation of lymph drainage area imaging.
15837669|NCT04143542|Procedure|trunk blocks|Comparison of trunks blocks and control groups for Postoperative Analgesia in Abdominal Surgery
15837670|NCT04143529|Behavioral|Personalized acceptance-based mindfulness exercise|The mindfulness intervention will be a video-flash found at http://www.pixelthoughts.co. In this exercise patients are asked to write down a concern or worry, and watch it get put into perspective within a 60 seconds time frame.
15837671|NCT04143529|Behavioral|Brief educational pamphlet|The control condition will be educational information on pain and stress that patients will read over within 60 seconds
15837763|NCT04142762|Drug|ABI-H2158|ABI-H2158 tablets
15837672|NCT04143516|Diagnostic Test|[18-F]- FDG - PET|Patients will undergo a limited non-contrast CT and first injection PET to localize the lesion
15837673|NCT04143516|Procedure|Thermal ablation (TA)|Standard ablation with the intent to create a radius of ablation at least 10 mm larger than the largest lesion diameter in order to achieve a minimum of 5 mm ablation margin around the tumor. Any radiographically-identified and biopsy-confirmed residual tumor will be treated on site with immediate ablation. This repeat ablation is not standard of care but will be performed as described for the initial ablation (in the same procedure session) and follow up will be resumed.
15837674|NCT04143516|Diagnostic Test|PET/CT Scan|Eligible patients will undergo PET/CT -guided thermal ablation as per standard IR guidelines. All patients will undergo PET/CT again, within approximately 6 weeks (+/- 2 weeks) of thermal ablation to evaluate for CN in the target tumor(s) or any sign of residual tissue enhancement, representing viable residual tumor and incomplete treatment.
15837675|NCT04143490|Other|Exercise|60 minutes of continuous exercise at 65% VO2peak and drink ingestion
15837676|NCT04143477|Drug|peficitinib|Oral
15837677|NCT04143464|Behavioral|Kyphosis-specific exercise class and kyphosis-specific exercise videos|"The kyphosis-specific exercise is based on the protocol published by Katzman and team in 2016. It includes warm-up, back muscle strength training, spine mobility training, spine alignment training, and stretching. The class will last around 60 minutes.
~The exercise videos have the same content as the kyphosis-specific exercise class. The participants are asked to practice everyday at home following the videos."
15837678|NCT04143451|Biological|Vaxigrip tetra|quadrivalent influenza vaccine
15837679|NCT04143451|Biological|Fluzone high-dose|high-dose trivalent influenza vaccine
15837680|NCT04143451|Drug|Aldara 5% Topical Cream|imiquimod cream
15837681|NCT04143451|Drug|Aqueous cream BP|inactive aqueous cream
15837682|NCT04143438|Procedure|EOS 3D imaging protocol pre- and post-surgery|Patients will undergo a EOS 3D Imaging protocol before and 6 months after undergoing patello-femoral surgery. This protocol is already used routinely in the hospital before every patello-femoral surgery.
15837683|NCT04143425|Diagnostic Test|3-Tesla conventional magnetic resonance imaging|T1-weighted, T2-weighted, fluid-attenuated inversion recovery, and contrast-enhanced T1-weighted imaging
15837684|NCT04143425|Diagnostic Test|Advanced imaging without contrast use|Diffusion-weighted imaging, amide proton transfer-weighted imaging, electrical properties tomography, and 2hG-magnetic resonance spectroscopy
15837685|NCT04143425|Diagnostic Test|Dynamic susceptibility contrast-weighted imaging|Cerebral blood volume and vessel architectural imaging parameters
15837686|NCT04143412|Drug|Tritace (Ramipril 10 mg)|Stratified randomized clinical trial
15837687|NCT04143399|Procedure|holmium laser enucleation of the prostate|cystoscopic transurethral enucleation of the prostate using Holmium laser (Versa pulse 100W; Lumenis; Germany)
15837688|NCT04143399|Procedure|Bipolar resection of the prostate|cystoscopic transurethral resection of the prostate using bipolar energy
15837689|NCT04143373|Procedure|warm saline irrigation|The objective of this research was to compare the effect of irrigation during impacted mandibular third molar surgery, with normal saline of 25 ± 2 ° C and 37 ± 1 ° C for control and experimental sides, respectively.
15837690|NCT04143360|Device|New Closed Drainage Device|For the first group, a new closed drainage device was adopted.
15837691|NCT04143360|Device|Traditional closed drainage device|For group 2, conventional closed drainage device was used.
15837692|NCT04143347|Other|No Intervention|
15837693|NCT04143334|Diagnostic Test|Conventional survey|
15837694|NCT04143321|Drug|Empagliflozin 25 MG|after washout period and EST and SAQ patients gave 25 mg Empagliflozin daily in experimental group
15837695|NCT04143308|Other|Simultaneous training of walking and cognitive group|"Device:
~SWATCH system (App & controller)
~Wearable technology Fitness wristband & APP"
15837696|NCT04143308|Other|Cognitive training group|"Device:
~SWATCH system (App)
~Wearable technology Fitness wristband & APP"
15837697|NCT04143308|Other|Treatment as usual group|Keep treatment as usual
15837698|NCT04143295|Drug|Diiodothyropropionic acid|Drug Administration
15837699|NCT04143282|Drug|Metformin plus chemotherapy|determine the effect of metformin along with standard chemotherapy
15837700|NCT04143282|Drug|Chemotherapy|standard chemotherapy
15837701|NCT04143269|Device|Non-invasive transcutaneous vagus nerve stimulation|Bilateral stimulation 4 times per day for 7 days (period 1) and 2 times per day for 8 weeks (period 2). The two periods are separated by a 2 weeks wash-out period.
15837702|NCT04143269|Device|Sham vagus nerve stimulation|"Bilateral stimulation 4 times per day for 7 days (period 1) and 2 times per day for 8 weeks (period 2). The two periods are separated by a 2 weeks wash-out period.
~The sham device produces a slight vibrating sensation, but do not provide any vagal nerve activation"
15837703|NCT04143256|Other|JUUL ENDS 5% Virginia Tobacco|JUUL ENDS Virginia Tobacco 5% nicotine strength
15837704|NCT04143256|Other|JUUL 3% Virginia Tobacco ENDS|JUUL ENDS Virginia Tobacco 3% nicotine strength
15837705|NCT04143256|Other|JUUL 5% Mint ENDS|JUUL ENDS Mint 5% nicotine strength
15837706|NCT04143256|Other|JUUL 3% Mint ENDS|JUUL ENDS Mint 3% nicotine strength
15837707|NCT04143256|Other|JUUL 5% Menthol ENDS|JUUL ENDS Menthol 5% nicotine strength
15837708|NCT04143256|Other|JUUL 3% Menthol ENDS|JUUL ENDS Menthol 3% nicotine strength
15837709|NCT04143256|Other|JUUL 5% Mango ENDS|JUUL ENDS Mango 5% nicotine strength
15837710|NCT04143256|Other|JUUL 3% Mango ENDS|JUUL ENDS Mango 3% nicotine strength
15837711|NCT04143256|Other|US Cigarette, Non-menthol - Marlboro Gold King Size|US Cigarette, Non-menthol - Marlboro Gold King Size
15837712|NCT04143256|Other|US Cigarette, Menthol - Newport King Size|US Cigarette, Menthol - Newport King Size
15837713|NCT04143243|Behavioral|ACT on Life|1 day group workshop of ACT plus ERS
15837714|NCT04143243|Behavioral|Education, Resources, and Support|1 day group workshop of Education, Resources, and Support
15837715|NCT04143230|Other|Screening for PC by means of two different screening tools|Screening of chronically ill patients admitted to an Internal Medicine Unit from the Emergency Department, for palliative care need, using of both the SIAARTI/NCCN screening tool (EST), and the Simplified Screening Tool (SST), derived from the first instrument.
15837716|NCT04143217|Drug|SPN-812|SPN-812 200 to 600 mg/day
15837764|NCT04142762|Drug|Itraconazole|Itraconazole capsules
15837717|NCT04143204|Other|Oral nutritional intake|The exposure are oral nutritional intake and all nutritional intake during early life (28 days), and insulin-like growth factor 1, leptin, Ghrelin, and C-peptide in serum at corrected age 40 gestational weeks.
15837718|NCT04143191|Drug|Sorafenib|Sorafenib is one of tyrosine kinase inhibitors. The initial dosage is 400mg orally, twice daily.
15837719|NCT04143191|Procedure|Transarterial chemoembolization|TACE including conventional TACE (cTACE) and DEB-TACE. Treatment choices are according to the specific condition of each patient and the experience of interventional radiologists.
15837720|NCT04143178|Other|Expressive Writing|The expressive writing is a form of writing therapy developed primarily by James W. Pennebaker in the late 1980s consisting of writing about stressful and traumatic experience for 15-20 min for 3 consecutive days, including one's thoughts and feelings. The expressive writing allows people to express and process emotions, feelings, and thoughts related to the life events and consequent changes and this may favor a mental reorganization of the negative events, a greater expression and regulation of the emotions related to them. This intervention could provoke social, emotional, and consequently, psychophysical changes as is showed in patients with chronic diseases and cancer. In the present study, to all participants in the writing group, 5 days after the transplant, has been asked to write for 3 consecutive days, 20 minutes each days about their deepest emotions and feelings related to the chronic failure, the transplant and their expectations after that.
15837721|NCT04143178|Other|Neutral Writing|Five days after the transplant, to the control group participants has been asked to write for 3 consecutive days 20 minutes a day on an assigned neutral theme (eg. describe 1 object in the room) as objectively as possible, without mentioning their emotions or thoughts related to it.
15837722|NCT04143165|Drug|Epidural block with lidocaine and triamcinilone|caudal epidural injections with 1% lidocaine hydrochloride (xylocaine AstraZeneca) 9 mL mixed with 1 mL of triamcinolone 40 milligrams (Kenacort Bristol Myers Squip)
15837723|NCT04143126|Behavioral|Cognitive Enhancement Therapy|An 18-month comprehensive, small group approach for the remediation of cognitive deficits in neurodevelopmental disorders consisting of individual sessions and 45 group training sessions in social cognition that are integrated with approximately 60 hours of computer assisted training in attention, memory, and problem solving skills.
15837724|NCT04143126|Behavioral|Enriched Supportive Therapy|An 18-month intervention that uses individual supportive therapy to help patients learn about schizophrenia, manage their emotions and stress, improve their social skills, and cope with everyday problems. Participants will learn about the impact of stress on their lives, and how to identify their own early cues of distress and apply effective coping strategies.
15837725|NCT04143113|Other|Decision Aid|Shared decision making tool
15837726|NCT04143100|Other|Survey|For our primary analysis (multiple regression) scores on the GAD-7, BAI and PHQ-9 will be used to predict dialysis adherence, as defined as minutes reduced (total dialysis prescribed -total actual time on machine) while controlling for age and gender.
15837727|NCT04143087|Drug|withdrawal TKIs or halve TKIs|Stop TKIs or treated by half TKIs
15837728|NCT04143074|Behavioral|multidisciplinary behavioral intervention|behavioral intervention - 4 visits with each of the specialist team (pediatrician, dietician, psychologist, physical activity specialist), (4 visits x 4 specialists). Each specialist ap. 30 min time. Wisits in 0-3m-6m-12m time frame. Visits focused on behavioral intervention - motivation for change and basic tools (dietician, physical activity specialist, psychologist) to implement change in nutrition and physical activity based on individual reediness for change (based on Prochaska model).
15837729|NCT04143061|Biological|Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine|Pharmaceutical form: solution for injection; Route of administration: intramuscular, 0.5 mL
15837730|NCT04143061|Biological|Meningococcal polysaccharide (serogroups A,C,Y and W-135) diphtheria toxoid conjugate vaccine|Pharmaceutical form: sterile aqueous solution; Route of administration: intramuscular, 0.5 mL
15837731|NCT04143061|Biological|Meningococcal polysaccharide (serogroups A, C, Y and W-135) vaccine|Pharmaceutical form: reconstituted solution for injection; Route of administration: intramuscular, 0.5 mL
15837732|NCT04143048|Other|DNA extraction of tumer tissue samples and high-throughput sequencing of small panels|DNA extraction of stromal tumor tissues and high-throughput sequencing of small panels were performed, and the relationship between the mutation spectrum of each sample and the corresponding patient clinical data (staging) was analyzed
15837733|NCT04143048|Other|DNA extraction of tumer tissue samples and blood sample and high-throughput sequencing of small panels|DNA extraction and small panel sequencing were performed for the two types of samples of the patients respectively, and the DNA sequencing results of the two types of samples were compared, and the clinical data of the corresponding patients were referenced to evaluate the consistency of the results of peripheral blood cfDNA and tissue gDNA for the gene detection of gastrointestinal stromal tumor
15837734|NCT04143048|Other|DNA extraction of tumer tissue samples and blood sample and high-throughput sequencing of small panels|DNA extraction and small panel sequencing were conducted for each patient sample. Based on the indicator results of the previous mutant spectrum for each stage of gastrointestinal stromal tumor, the clinical stage classification of patients and the benign and malignant nodules were determined by the mutant spectrum, and compared with the real clinical data of patients
15837736|NCT04143022|Device|acupuncture press needle|Press needle will be applied to acupoints at Jin's 3-tongue point ( EX-HN21 and the two extra channel points, 0.8 individual cun lateral to both sides of EX-HN21) and EX-HN25 in group A and at EX-CA1, EX-CA5 and EX-CA6 in group B. Each subject will start first course and receive the treatment 2 times a week for 4 weeks (8 times in total). Then, it takes 2-week washout period and make group A and group B crossover. Second course begins after 2-week washout period with the same treatment times as the first course.
15837737|NCT04143009|Behavioral|Adapted Friendship Bench|In the AFB intervention, the existing Friendship Bench intervention protocol will be adapted to address the unique needs of HIV-infected women. This will include integrating problem solving therapy- based ART adherence support into existing counseling sessions and providing opportunities for participants to address HIV-specific concerns, such as stigma, disclosure, mother-to-child HIV transmission or other issues women identify during counseling sessions. AFB will include 4 individual prenatal counseling session and 2 group postnatal counseling sessions. No specific retention support will be provided, but participants may identify barriers to engagement in HIV care to address during their pre- or postnatal counseling sessions.
15837738|NCT04143009|Behavioral|Enhanced Friendship Bench|EFB will include all elements of AFB, but will additionally integrate retention strategies to support engagement in care for HIV-infected women with PND. To provide additional social support for participants, one support session will be added to the AFB at which participants will be invited to bring a person of her choice who can be a support to her in managing both her HIV and/or depression. To assist women with receiving their medication during late pregnancy and postpartum, a trained psychosocial counselor will also conduct up to six home visits in the EFB arm. At each home visit, counselors will be able to deliver a participants' medications and conduct a counseling session.
15837739|NCT04143009|Other|Enhanced Standard Care (Control)|Standard care for mental health in public facilities in Malawi includes options for basic supportive counseling by the primary provider or nurse, medication management by the primary provider, referral to the clinic psychiatric nurse or mental health clinic, or in more severe cases referral to the psychiatric units at tertiary care hospitals. For this study, standard care will be enhanced by a trained study research assistant who will provide mental health evaluation; brief supportive counseling; information, education, and support on common mental disorders; and (if indicated) facilitation of referral to the clinic's psychiatric nurse or mental health clinic. The study research assistant will have up to 3 follow-up contacts with the participant to assess whether she has followed up on recommended referrals or treatment plans and to assess whether any further outreach is indicated.
15837740|NCT04142996|Device|Theta burst stimulation|Cool B70 coil (left DLPFC) and Cool B65 active/placebo coil (right DLPFC), with X100 MagPro rTMS Device (Magventure A/S, Farum, Denmark)
15837741|NCT04142983|Biological|Adacel|0.5 mL, Intramuscular
15837742|NCT04142970|Drug|HSK3486|HSK3486，Initially 0.4 mg/kg was administered as a 1 minute bolus, followed immediately by a constant infusion dose of 0.4 mg/kg/h administered as a 30 minute infusion via infusion pump.
15837743|NCT04142957|Other|COPD Pal|'COPD Pal' aims to allow people with COPD to track and manage their condition. It enables patients to log symptoms (e.g. COPD assessment Test), wellness (e.g. quality of life such as EQ-5D), and medications, to help them become more engaged in their own care.
15837744|NCT04142944|Device|Dexcom G6 with alert|Dexcom G6 CGM device with the predictive hypoglycaemia alert function
15837745|NCT04142944|Device|Dexcom G6 without alert|Dexcom G6 CGM device without the predictive hypoglycaemia alert function
15837746|NCT04142931|Combination Product|ImmunicomAIAC|filtration through the ImmunicomAIAC followed by Nivolumab Administrated IV starting C2.
15837747|NCT04142918|Other|Immunostaining|Immunostaining of oral mucosa/gingiva samples
15837748|NCT04142892|Drug|Onapristone|50 mg given orally (PO), twice a day (BID), in a continuous schedule (QD) during 3 weeks (+/-3 days)
15837749|NCT04142879|Device|Viz Device Software|Viz uses artificial intelligence to automatically detect, triage and notify stroke specialists of suspected large vessel occlusion (LVOs) and computed tomography angiogram (CTA) imaging. Viz includes functionality to automatically process computed tomography perfusion (CTP) images. Additionally, Viz includes a mobile non-diagnostic image viewer and HIPAA-compliant secure messaging.
15837750|NCT04142866|Device|Anodal transcranial direct current stimulation|2 milliamps (mA) of stimulation is induced between two 5 cm x 7 cm saline soaked sponges where one sponge (anode) is placed on the scalp over the targeted cortical region and the other (cathode) is placed on the right side of the forehead. Ramping up of the current to 2 milliamps (mA) occurs over 30 seconds to allow participants to habituate to the tingling sensation. In the active tDCS condition, stimulation continues for the first 20 minutes of the 60-minute treatment session, and then ramps back down to 0 milliamps (mA).
15837751|NCT04142866|Device|Sham transcranial direct current stimulation|2 milliamps (mA) of stimulation is induced between two 5 cm x 7 cm saline soaked sponges where one sponge (anode) is placed on the scalp over the targeted cortical region and the other (cathode) is placed on the right side of the forehead. Ramping up of the current to 2 milliamps (mA) occurs over 30 seconds to allow participants to habituate to the tingling sensation. In the sham tDCS condition, the current is only on for 30 seconds before it is ramped back down to 0 milliamps (mA), although the electrodes are still worn for 20 minutes.
15837752|NCT04142866|Behavioral|Speech-Language Therapy (SLT)|Therapy provided is Verb Network Strengthening Treatment (VNeST). Therapy sessions last for 60 minutes and are provided twice weekly for 8 weeks. Active or sham tDCS is delivered during the first 20 minutes of therapy. The therapist is blinded to stimulation condition (active or sham).
15837753|NCT04142853|Other|Training intervention + Dance intervention|Training intervention + Dance intervention
15837754|NCT04142840|Drug|Dexmedetomidine|a selective α-2 adrenoceptor agonist which is widely used as an adjuvant to general anesthesia
15837755|NCT04142840|Drug|Propofol|a short -acting medication that result in a decreased level of consciousness and lack of memory for events,widely used including the starting and maintenance of general anesthesia.
15837756|NCT04142827|Device|High Flow Humidification|myAirvo2 gives at home for long therapy treatment
15837757|NCT04142814|Procedure|T-PEP|"First of all, a corrugated tube for ventilation is assembled: in one end with an antibacterial filter for ventilation and then an inflation system (like Auxiliary Manual Breathing Unit - AMBU); in the other end with a connector and then a one-way PEP Valve. The latter holds a junction for the tracheal cannula and a pressure gauge. A Venturi Resistor is placed in the expiratory part of the PEP Valve.
~After connection to the tracheal cannula, the disostructive maneuver is manually executed by a respiratory physiotherapist."
15837758|NCT04142814|Procedure|IPV|IPV is delivered via a commercial device that can be set by frequency, duration of inspiratory time, inspiratory-expiratory ratio and positive end-expiratory pressure, based on patients characteristics and clinical needs. It is connected to the patient's tracheal cannula via a Mount catheter. The air supplied is sterile, due to the presence of an antibacterial filter present in the device.
15837759|NCT04142801|Device|MeMo web application|The patient betwenn 2 consultation could use the application MeMo. MeMo is a web application that can thus be used on any web browser (computer or tablet). On tablet, the application can be installed on home screen to look like a native app, and used offline.
15837760|NCT04142801|Other|Control group|the patient have the classical follow up at the memory center (consultation)
15837761|NCT04142788|Drug|Patiromer|Patiromer (8.4g/day to 25.2g/day) and spironolactone (up to 200mg/day) or eplerenone (up to 50mg/day if spironolactone not acceptable). Treatments should be titrated to maintain serum potassium close to the target of 4.5mmol/L.
15837762|NCT04142775|Other|complication versus no complication|development of ICH
15837767|NCT04142762|Drug|Ethinyl Estradiol / Levonorgestrel|Ethinyl Estradiol / Levonorgestrel tablets
15837768|NCT04142762|Drug|Esomeprazole|Esomeprazole capsules
15837769|NCT04142762|Drug|Placebo matching oral contraceptive|Placebo matching Ethinyl Estradiol / Levonorgestrel tablets
15837770|NCT04142749|Drug|Oltipraz|Total 90mg, By mouth, TID
15837771|NCT04142749|Drug|Placebos|Total 90mg, By mouth, TID
15837772|NCT04142736|Other|Prone Position|The best-fitting and most-tolerated oxygen interface will be used in the prone position--this could be different from patient to patient, and different from what is used in the supine position, and could differ between patients but also institutions (i.e., depending on the availability of masks with or without a reservoir bag and with or without the Venturi system, HFNO, CPAP or NIV). The patient will be placed in the prone position for at least 2 hours, which may be prolonged if the patient is comfortable or interrupted if the patient presents any criteria for prone position discontinuation. After the prone position period, the patient will be rotated to the semi-recumbent supine position for at least 2 hours and a maximum of 4 hours. This 2-hour time frame will depend on nursing availability, need for hygiene, complementary explorations, or diet.
15837773|NCT04142723|Biological|blood withdraw|venous blood sampling
15837774|NCT04142710|Device|Telemedicine: tablet and possibly tools to perform measurements|Users of telemedicine can answer simple questions about their health condition and/or perform measurements related to their health (e.g., blood pressure, blood sugar, oxygen saturation, weight) via a tablet or a similar device. The results are transferred from the measuring devices to the tablet so that users can easily see them and track their own results over time. The results are transmitted digitally to a follow-up service. The follow-up service contacts the patient in case of signs of deterioration or when measurements lie outside what is normal values for the individual. The follow-up service provides medical support and guidance based on the patient's needs and plan for follow-up, and will, in consultation with the patient, assess whether this should contact their GP/emergency room.
15837775|NCT04142697|Behavioral|Heading direction adaptation|Will adapt subject's perceived heading direction using exposure to visual environments that include rotation and situations where visual and inertial heading direction are systematically offset.
15837776|NCT04142671|Other|Individualised gait modification intervention|An individualised gait modification intervention to reduce knee joint loading. Knee joint loading will be presented in real-time during treadmill walking. A 10% reduction of each patients baseline knee loading will be used as a target threshold along with visualisation of the history of 5 previous steps. Patients are encouraged to determine their own gait modification strategy that is most efficient for them. Previous examples of gait modifications that mechanically reduce knee loading will be presented to them.
15837777|NCT04142658|Drug|Apixaban 5 MG|"For patients that do NOT meet the following criteria
~age ≥ 80 years
~weight ≤ 60 kilograms
~creatinine ≥ 1.5 mg/dL (133 micromol/L)"
15837778|NCT04142658|Drug|Apixaban 2.5 MG|"For patients that meet at least 2 of the following criteria
~age ≥ 80 years
~weight ≤ 60 kilograms
~creatinine ≥ 1.5 mg/dL (133 micromol/L)"
15837779|NCT04142658|Drug|Warfarin|Active Control Intervention
15837780|NCT04142658|Device|On-X Aortic Mechanical Valve|Inclusion Criterion: Implantation of an On-X mechanical valve in the aortic position at least 3 months (90 days) ago.
15837781|NCT04142645|Device|OptiMEDs|"The OptiMEDs intervention is a multi-faceted intervention combining:
~an ICT platform:
~automatic and secure capture of individual prescribing information from the electronic medication administration records in the nursing home
~a tool for structured nurse observations of side effects, derived from the existing Pharmanurse application (20) (used to list potential medication side effects, based on the individual medication chart of the nursing home residents) to support monitoring of medication safety by nurses.
~an electronic decision support tool for the appraisal of potentially inappropriate medication (explicit criteria of misuse and underused of medication, based on existing lists of explicit criteria (PIMs)), use of medication with anticholinergic properties and medication inappropriate in view of the limited life expectancy.
~a multidisciplinary medication review with the input of GPs, trained community-pharmacists and nurses."
15837782|NCT04142632|Procedure|clinical and paraclinical examination|Physical examination of the penis, ultrasonography of the bladder end the testis, Biological sample for endocrine assessment
15837784|NCT04142606|Other|fetal MRI|The MRI examination added by this research, without injection or sedation, induces no risk for the mother as for the fetus (s)
15837785|NCT04142554|Drug|Parsaclisib|Parsaclisib tablets (1.0, 2.5 or 5 mg) are administered orally daily for up to 14 days
15837786|NCT04142541|Device|Neuroguard® IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection (Neuroguard IEP System)|The Neuroguard® IEP 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection is indicated for improving the carotid luminal diameter in patients with clinically significant carotid artery stenosis and for the simultaneous capture and removal of embolic material during angioplasty and stenting.
15837787|NCT04142528|Device|ParkinPal|Wear and periodic recording of motion data during daily wear
15837788|NCT04142515|Other|no intervention|no intervention
15837789|NCT04142502|Drug|Propofol|Propofol as a sedation drug
15837790|NCT04142502|Drug|Dexmedetomidin|Dexmedetomidine as a sedation drug
15837791|NCT04142489|Other|solar irradiation and biopsies|the minimum erythematous dose (DEM) will be calculated using a solar irradiator on the scalp (study area) and on a forearm (control area). On D2 (D1+24h) a solar irradiation corresponding to 2 DEM will be performed on a region of the scalp (studied area), as well as on a forearm (control area). A 3mm biopsy will be performed 15mn after irradiation in these 2 regions to study DNA damage. At D4 (D2+48h) a 2nd biopsy of 3 mm will be performed to study the repair of induced DNA damage.
15837792|NCT04142476|Other|interview|interviews with patient's pharmacist to motivate in the hormonotherapy's compliance.
15837826|NCT04142229|Device|iAPS|The AID system (iAPS) is comprised of an insulin pump, a Dexcom G6 continuous glucose monitoring sensor, and a smart phone that contains the algorithm and communicates with the other devices.
15837827|NCT04142229|Other|Sensor-Augmented Pump|Subjects will use their home insulin pump and a Dexcom G6 continuous glucose monitoring sensor.
15837828|NCT04142216|Dietary Supplement|Chewing Gum|The patients will chew one piece of regular chewing gum six times in a day and feeling of thirst for ten minutes for three months.
15837793|NCT04142463|Other|Care pathway|A care pathway is a complex intervention for the mutual decision-making and organisation of care processes for a well-defined group of patients during a well-defined period. Care pathways can be used to optimise care processes when problems arise on communication, coordination, standardisation and monitoring of care for a specific group of patients. A care pathway for patients treated with OACD, should therefore consist of all relevant sustainable interventions that cover the continuum of the medicines' pathway with the aim to support self-management (e.g. consultations with doctors, contact moments with nurses, telephone follow-up, ...). The role of each stakeholder in the different interventions should be well-described including communication strategies between HCPs from primary and secondary care.
15837794|NCT04142450|Device|CoolSculpting® System|Each participant underwent a single treatment session that was comprised of timed segments of cooling followed by 2 minutes of manual massage.
15837795|NCT04142437|Drug|larotrectinib(Vitrakvi, BAY2757556)|In the study, patients treated under local standard of care clinical practice; all decisions in terms of diagnostic procedures, treatments, management of the disease, and resource utilization are fully dependent on mutual agreement between the patient and the attending physician, without interference by the study initiator or study protocol
15837796|NCT04142424|Drug|AZD2693|Subjects will receive SC injection of AZD2693 as per the arms they are randomized.
15837797|NCT04142424|Drug|Placebo|Subjects will receive SC injection of placebo matched to AZD2693, as per the arms they are randomized.
15837798|NCT04142411|Drug|Insulin|Ultrasound guided perineural injection therapy (PIT)
15837799|NCT04142411|Drug|Sodium Hyaluronate|Ultrasound guided perineural injection therapy (PIT)
15837800|NCT04142411|Device|Ultrasound|Philips Neuromuscular Ultrasound
15837813|NCT04142359|Biological|BCG in Combination with N-803|BCG in Combination with N-803
15837814|NCT04142359|Drug|N-803 alone|N-803 alone
15837815|NCT04142346|Behavioral|Sitting + moderate intensity breaks|Participants will be followed in a randomized crossover trial undertaken at Faculty of Human Kinetics between April and August 2019. Participants will attend to the laboratory on twelve separate occasions: visit 1 (day 1), baseline assessments for body composition; visit 2 (day 2), cardiorespiratory fitness assessment; visit 3 (day 3), OGTT and the first randomized experimental protocol; visit 4 (day 4), follow-up OGTT; visit 5 (4-6 days after the first experimental protocol), OGTT and the remaining experimental protocol; visit 6 (day following the previous experimental protocol), follow-up OGTT. An additional 6 visits will be performed following the same rational, after a 2-week period of detraining, where participants will be instructed to refrain from structured exercise. The follow-up assessments for body composition and cardiorespiratory fitness will be accomplished after the protocols.
15837816|NCT04142333|Genetic|GIA|Patients receive a secure GIA link from their provider and then are able to send their relatives the link to GIA through texting, email, and/or Facebook messenger. Once a relative clicks on the provided link, GIA's platform is structured as a decision tree, allowing family members to construct a personalized conversation about their family member's test results. This can be done either on a smartphone or computer. GIA provides basic genetics education and risk assessment and connects family members with local genetic counseling resources to continue this conversation and/or go forward with genetic testing. At the end of the conversation, the family member has the option of having a transcript sent to them via email for their reference. The objective of the current study is to evaluate the application of GIA for cascade testing in newly identified high risk breast and gynecologic mutation carriers.
15837817|NCT04142320|Device|closed-loop rTMS|Delivers patterned magnetic stimulation in closed-loop fashion
15837818|NCT04142320|Device|open-loop rTMS|Delivers patterned magnetic stimulation in open-loop fashion
15837819|NCT04142320|Device|sham rTMS|Delivers placebo magnetic stimulation
15837820|NCT04142307|Device|Biofeedback Training|Microperimeter biofeedback training as described provides to the patient a variable frequency sound and a luminous stimulus that vary according to the eyes position, thus guides the oculomotor control and fixation stability accordingly.
15837821|NCT04142307|Device|Sham - simulated BT|The simulated biofeedback training for Group B involves the following: each session includes presentation of a C10-2 microperimetry program. The procedure involves presentation of a standard LED fixation target (FT) consisting of a small red circle of about 0.76° diameter. Initially the participant will be instructed to stare at the FT circle. Following this stage the participant will be guided to look at the FT and simultaneously to be aware of any flashing lights in the periphery of vision. As performing this task, the participant will actively control the eye movements and similar to computer games, the patient has to identify targets in the peripheral field of vision and respond by pressing a button.
15837822|NCT04142294|Dietary Supplement|Histidine|ingestion of encapsulated high quality histidine for four continuous weeks followed by a washout period of 3 weeks
15837823|NCT04142255|Biological|FMT|FMT administration starts on the first week of enrollment. Age-based dose of FMT is taken once a day for the first three days of the first week. Then once a week for 3 weeks.
15837824|NCT04142242|Biological|Meningococcal Polysaccharide (serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine|Pharmaceutical form: Solution for injection; Route of administration: Intramuscular
15837825|NCT04142242|Other|Blood sample|Blood sample for assessment of antibody persistence.
15837829|NCT04142203|Other|23 h surgery|Patients were treated in 23 surgical unit
15837830|NCT04142190|Drug|ELONVA|Elonva is a solution for injection that contains the active substance corifollitropin alfa. It is available as a pre-filled syringe (100 and 150 micrograms).Elonva is used in women who are undergoing fertility treatment to stimulate the development of more than one mature egg at a time in the ovaries.
15837831|NCT04142190|Drug|PUREGON|Puregon contains the active substance follitropin beta. fertilisation). Puregon is administered to stimulate the ovaries to produce more than one egg at a time
15837838|NCT04142164|Other|MacInfo presentation|Presentation about intravitreal drug injection
15837839|NCT04142164|Other|Placebo presentation|Placebo presentation
15837840|NCT04142151|Drug|Sanchitongshu|SanchiTongshu capsule produced by Chengdu Huashen Group Co., Ltd.
15837841|NCT04142151|Drug|Aspirin|Aspirin produced by Bayer Co., Ltd.
15837842|NCT04142151|Drug|Clopidogrel|Clopidogrel produced by Shenzhen Salubris Co., Ltd.
15837843|NCT04142151|Drug|placebo of Sanchitongshu|SanchiTongshu palcebo capsule contained dark brown muscovada sugar and the same inactive excipient (starch). Produced by Chengdu Huashen Group Co., Ltd.
15837844|NCT04142138|Other|DASH|DASH diet is based on low salt, high potassium components, and is comprised of mainly fruits and vegetables. During hospitalization we will collect laboratory data of blood and urine, and follow participants clinically by measuring blood pressure.
15837845|NCT04142125|Drug|Rivaroxaban 2.5 Mg Oral Tablet bid|Pts will receive rivaroxaban + aspirin
15837846|NCT04142125|Drug|Acetylsalicyclic acid 81 mg tablet qd|Pts will receive ASA
15837847|NCT04142112|Device|Ohana IVF Sperm Preparation Kit (OHB035)|The Ohana IVF Sperm Preparation Kit (OHB035) contains media for processing sperm through a series of timed steps prior to insemination with oocytes.
15837848|NCT04142112|Device|Standard IVF Preparation Kit (OHB037)|The Standard IVF Sperm Preparation Kit (OHB037) contains media for processing sperm per the traditional steps prior to insemination with oocytes.
15837849|NCT04142099|Behavioral|skin to skin contact 60 min group|Newborns are exposed to maternal and child skin within five minutes of birth for 60 min.
15837850|NCT04142099|Behavioral|skin to skin contact 20min group|Newborns are exposed to maternal and child skin within five minutes of birth for 20 min.
15837851|NCT04142086|Biological|Yellow fever vaccine (produced on serum-free Vero cells), Dosage 1 vYF vaccine|Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous
15837852|NCT04142086|Biological|Yellow fever vaccine (produced on serum-free Vero cells), Dosage 2 vYF vaccine|Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous
15837853|NCT04142086|Biological|Yellow fever vaccine (produced on serum-free Vero cells), Dosage 3 vYF vaccine|Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous
15837854|NCT04142086|Biological|Yellow fever vaccine|Pharmaceutical form: Powder and diluent for suspension for injection Route of administration: Subcutaneous
15837855|NCT04142060|Drug|Enzalutamide|Patients will be dispensed with oral enzalutamide 160 mg (four 40 mg capsules) as a self-administered single oral daily dose, continuously.
15837890|NCT04141761|Dietary Supplement|Visbiome|This group will receive Visbiome probiotic in powder form.
15837857|NCT04142021|Diagnostic Test|Coronary computed tomography angiography|Surgery planning done based solely on coronary computed tomography angiography.
15837858|NCT04142008|Device|Walk with Me app|For 10 weeks the subjects will use a mobile application (Walk with Me). The aim of this study is to investigate the usability of the mobile application, as well as investigating if the mobile application effects walking
15837859|NCT04141995|Drug|Digoxin|Tablet, Oral: Generic: 0.125 mg, 0.25 mg
15837860|NCT04141995|Drug|5Fluorouracil|5-FU will be given as a 46 hour continuous IV infusion
15837861|NCT04141995|Drug|Calcium Leucovorin|IV injection over 90 minutes
15837862|NCT04141995|Drug|Irinotecan|IV administration over 90 minutes
15837863|NCT04141995|Drug|Oxaliplatin|IV administration
15837864|NCT04141982|Diagnostic Test|T-Cell SelectTM Kit|The T-Cell Select kit is intended for the isolation of mononuclear immune cells from whole blood, using positive selection via a magnetic bead-based cell separation system, for use in the T-SPOT.TB assay.
15837865|NCT04141969|Dietary Supplement|RLP|RLP nutraceutical
15837866|NCT04141969|Other|Placebo|Inert brown powder
15837867|NCT04141956|Other|High-Flow Nasal Cannula|Incidence of nasal High Flow Nasal Cannula (HFNC) Oxygen therapy in patients admitted to intensive care.
15837868|NCT04141943|Other|Virtual reality|The patients who are allocated to the VR arm will receive information about radiotherapy via virtual reality.
15837869|NCT04141930|Drug|Baloxavir Marboxil|Individuals willing and able, will receive a weight-based oral dose of baloxavir within 48 hours of symptom onset
15837870|NCT04141917|Combination Product|Point-of-care molecular testing and treatment of influenza|Eligible individuals will be tested on site with a point-of-care molecular influenza test and, if positive, offered antiviral treatment with baloxavir for those aged ≥12 years, or oseltamivir for those aged <12 years; pregnant; breastfeeding; liver disease; or are immunosuppressed. Follow-up nasal swabs and symptom diaries will be collected from participants 2 or 3 days after receiving the antiviral, and again 5, 6, or 7 days after receiving.
15837871|NCT04141904|Drug|Tofacitinib 5 MG [Xeljanz]|Tofacitinib 5mg capsules twice a day for 7-10 days
15837872|NCT04141904|Other|Placebo|Placebo capsules twice a day for 7-10 days
15837873|NCT04141891|Behavioral|Driving Decision Aid|Healthwise DDA
15837874|NCT04141891|Behavioral|Older Drivers Website|National Institute on Aging (NIA) Older Drivers Website
15837875|NCT04141878|Behavioral|Aerobic Exercise|Participants will follow a structured program that includes exercise 3 times per week for about 30 minutes each time. The type of aerobic exercise may vary, but will primarily focus on walking tutorials.
15837876|NCT04141878|Behavioral|Diet Skills|Participants will attend weekly classes focused on incorporating heart healthy foods into their existing diets. Calories will be restricted, and portion control will be taught with the goal of losing body weight. Hands-on skills will be taught for preparing healthy home-cooked meals by professional chefs.
15837877|NCT04141865|Device|Xen|Xen microstent implantation
15837878|NCT04141865|Device|Aqueous shunt|Aqueous shunt implantation
15837879|NCT04141852|Device|Implantation of VasQ device|"The VasQ external support device (Laminate Medical Technologies, Israel) is a novel Nitinol implant, externally surrounding and supporting the vein and hugging the artery near the junction site, without being in contact with the blood flow."
15837880|NCT04141839|Behavioral|Safer Bars|Safer Bars, a primary perpetration prevention program based on a bystander intervention model and the theory of planned behavior. Bar staff are trained to recognize and respond to sexual aggression and its precursors among patrons.
15837881|NCT04141826|Dietary Supplement|Hydrolysed whey|500 mL solution of 25 gram hydrolysed whey per day during 4 weeks
15837882|NCT04141826|Dietary Supplement|Intact whey|500 mL solution of 25 gram intact whey per day during 4 weeks
15837883|NCT04141826|Dietary Supplement|Caseinate|500 mL solution of 25 gram casein ate per day during 4 weeks
15837884|NCT04141787|Drug|Ceftriaxone|"Participants with methicillin-sensitive deep-seated staphylococcal infections eligible for treatment on home IV will be randomly assigned to a treatment group of ceftriaxone or standard therapy/usual antibiotics with either cloxacillin, cefazolin or daptomycin. The treatment with one of the three standard therapies/usual antibiotics will be left to the discretion of the treating Infectious Disease doctor, in line with current standards of practice."
15837885|NCT04141787|Drug|Usual Antibiotics (Cloxacillin, Cefazolin, Daptomycin)|"Participants with methicillin-sensitive deep-seated staphylococcal infections eligible for treatment on home IV will be randomly assigned to a treatment group of ceftriaxone or standard therapy/usual antibiotics with either cloxacillin, cefazolin or daptomycin. The treatment with one of the three standard therapies/usual antibiotics will be left to the discretion of the treating Infectious Disease doctor, in line with current standards of practice."
15837919|NCT04141488|Other|experimantal group|Control Group
15837891|NCT04141761|Other|Placebo|This group will receive a placebo in powder form.
15837892|NCT04141748|Device|Symphonie Aqua SystemTM|a water filled cylinder that can be pressurized around the residual limb to support body weight
15837893|NCT04141748|Procedure|Hand Casting|plaster of Paris or fiberglass bandages are wrapped around the residual limb
15837894|NCT04141735|Diagnostic Test|ultrasound|no intervention
15837895|NCT04141722|Behavioral|Overnight sleep|Participant sent home to sleep overnight wearing PSG.
15837896|NCT04141722|Behavioral|Wake|Participant sent to go about normal daily routine, instructed not to nap, drink caffeine, or engage in strenuous exercise.
15837897|NCT04141709|Radiation|local ablative radiotherapy|"Within the scope of the study, irradiation with two irradiation schemes is possible (the scheme applied is recorded in the CRF):
~Scheme A 3*10 Gy (once a day, 2-3 days a week)
~Scheme B 25*2 Gy (once a day, 5 days a week) The decision which irradiation scheme (3*10 Gy or 25*2 Gy) to use is made by the treating physician based on the anatomical position, the size of the metastases and the expected normal tissue load. Hypofractionated irradiation in three fractions is only possible if the limit values for the risk organs are adhered to. Radiotherapy should be performed with photons."
15837898|NCT04141696|Drug|Ketamine|Given intravenously over 40 minutes
15837899|NCT04141696|Drug|Midazolam|Given intravenously over 40 minutes
15837900|NCT04141683|Diagnostic Test|Stress Echocardiography|Dynamic stress echocardiography using a cycle ergometer on a semi supine exercise table.
15837901|NCT04141683|Diagnostic Test|Pressure volume loop analysis|Pressure volume loop analysis unsing conductance catheter measurements during right heart catheterization.
15837902|NCT04141683|Procedure|Tricuspid valve repair or replacement|Tricuspid valve repair or replacement using a surgical or interventionale approach according to local heart team recommendation and patients' preference.
15837903|NCT04141670|Drug|S48168|A novel oral small molecule which is designed to repair leaky RYR1 channels
15837904|NCT04141657|Other|Pharmacogenetic test|Buccal swabs are a relatively non-invasive way to collect deoxyribonucleic acid (DNA) samples for testing. A buccal swab will be performed to collect DNA from the cells on the inside of a subject's cheek for phenotyping of CYP3A4.
15837905|NCT04141644|Drug|Ipilimumab|Cohort 1: Osi 40 mg or 80 mg daily; Ipi 3 mg/kg every 3 weeks Cohort 2: Osi 40 mg or 80 mg daily; Ipi 1 mg/kg every 3 weeks
15837906|NCT04141644|Drug|Osimertinib|Cohort 1: Osi 40 mg or 80 mg daily; Ipi 3 mg/kg every 3 weeks Cohort 2: Osi 40 mg or 80 mg daily; Ipi 1 mg/kg every 3 weeks
15837907|NCT04141631|Drug|EPO (600UI/Kg, sub-cutaneous) and Ferric Carboxymaltose (FCM) (20 mg/kg in 250 mL of saline solution 0.9% over 15 min)|"EPO (600UI/Kg, sub-cutaneous) and Ferric Carboxymaltose (FCM) (20 mg/kg in 250 mL of saline solution 0.9% over 15 min) will be administered if
~Hb < 12g/dL the day before surgery
~Hb ≥ 7g/dL AND ScvO2 > 65% in postoperative ICU stay
~Postoperative Transfusion will be guided by ScvO2 values :
~if Hb ≤ 8 g/dL AND ScvO2 ≤ 65% or if Hb < 7g/dL independently of ScVO2 value"
15837908|NCT04141605|Device|SherpaPak Cardiac Transport System|"The Paragonix SherpaPak Cardiac Transport System (SherpaPak CTS) is an ultraportable hypothermic preservation and transport system intended for use with donor hearts. The device is a legally marketed, FDA cleared medical device in the United States and CE Marked medical device in the European Union.
~The SherpaPak CTS consists of multiple components: 1) outer transport shipper which contains within various non-ice based temperature controlled packaging elements, 2) an inner and outer hard shell assembly which provides a rigid barrier enclosure in which the heart is immersed and suspended in a cold storage solution cleared for use in storing and transporting donor hearts, 3) a data logger that monitors and displays the temperature of the cold storage solution in which the heart is stored during transport, and 4) four size heart connectors designed to accommodate various size aortic stem diameters by which donor hearts are attached."
15837909|NCT04141592|Procedure|Bariatric Surgery|Already clinically indicated surgical procedures
15837910|NCT04141579|Drug|Evolocumab 140 MG/ML [Repatha]|Evolocumab (also known as Repatha, formerly referred to as AMG 145) is a human monoclonal immunoglobulin G2 (IgG2) that specifically binds to proprotein convertase subtilisin/kexin type 9 (PCSK9) preventing its interaction with the low-density lipoprotein receptor (LDLR). The inhibition of PCSK9 by evolocumab leads to increased LDLR expression and subsequent decreased circulating concentrations of low-density lipoprotein cholesterol (LDL-C).
15837911|NCT04141566|Procedure|Perineal pseudocontinent colostomy|"The procedure is performed in 2stages: as a usual APR starting by a laparoscopic approach esnsuring a complete mesorectal excision,then a perineal approach ensuring an extended excision of the entire internal and external sphincter complex, allowing the excision of the specimen.
~8to10cm of tof the colon is resected and harvested as a free graft, stripped of its meso and epiploics , then from its mucosa and placed in an antibiotic solution for 10min. This graft is wrapped snugly around the end of the colon 2-3 cm from its distal end for 1 and a half round. Absorbable 3.0 Sutures are taken to hold it in place. The end of the colon is brought out as a stoma in the perineum.
~Colonic irrigations are started from the third day according to the protocol previously reported. Patients and one of their family members are daily educated and assisted while performing colonic irrigations by specialized nurses."
15837912|NCT04141566|Procedure|Permanent left iliac colostomy|After a usual laparoscopic APR, the perineal wound is closed and a permanent left iliac colostomy is performed
15837913|NCT04141553|Drug|Diltiazem Injection|Randomization to one of to active comparator groups
15837914|NCT04141540|Genetic|Molecular analyses|Comparaison of the molecular profil between two monozygotic twins carrying a deletion 22q11.2
15837915|NCT04141527|Procedure|Spinal analgesia|Spinal analgesia (SA) was provided by a resident or specialist anaesthesiologist with the patient in a sitting or a recumbent position. A pencil-point needle, primarily 27 G (0.4 mm), otherwise 25 G (0.5 mm), was used for transdermal intrathecal administration of 2.0 ml of sufentanil 5 µg/ml (Sufenta®, Janssen-Cilag AB, Solna, Sweden) at low-lumbar level. Blood pressure was recorded before, immediately after, and at five-minute intervals for 20 minutes after the block. Any decrease in systolic pressure to <100 mmHg or a decrease >20% from the baseline level despite infusion of crystalloid was defined to indicate maternal hypotension.
15837916|NCT04141514|Other|therapeutic fasting|fasting limited to daily 250 kcal during 3 days (day before chemotherapy, the D day of the chemotherapy and the day after chemotherapy)
15837917|NCT04141501|Drug|Psilocybin|single dose of psilocybin (25mg). orally in form of a capsule
15837918|NCT04141501|Drug|Placebo oral capsule|single dose of mannitol (100%)
15837920|NCT04141475|Dietary Supplement|Physiomance acide lipoïque gold|1 capsule of 300 mg in the morning outside a meal and 1 capsule of 300 mg in the evening outside a meal during 12 weeks
15837921|NCT04141475|Dietary Supplement|Placebo - Physiomance acide lipoïque gold|1 capsule of 300 mg in the morning outside a meal and 1 capsule of 300 mg in the evening outside a meal during 12 weeks
15837922|NCT04141462|Genetic|blood sample|blood test
15837923|NCT04141449|Other|Potlako intervention|Combined provider, patient, and health system intervention to expedite cancer diagnosis and care.
15837924|NCT04141449|Other|Enhanced care|Provider education and limited patient counseling.
15837925|NCT04141436|Behavioral|Interventions Based on Hypnofertility|Affirmation Visualization Imagination Relaxation
15837926|NCT04141436|Other|Routine clinical procedure|Routine clinical procedure
15837927|NCT04141423|Drug|Tregopil|Insulin Tregopil is recombinant human insulin modified by a single amphiphilic oligomer covalently linked via an amide bond to lysine at position 29 of the B-chain. This alters the physicochemical characteristics of the molecule, leading to enhanced stability and resistance to intestinal degradation following oral administration.
15837928|NCT04141410|Drug|Levosimendan|Use of Levosimendan in cardiogenic shock during sepsis
15837929|NCT04141410|Device|Echocardiography|Use of global longitudinal strain in cardiogenic shock during sepsis
15837930|NCT04141397|Genetic|Initiation of POG-related WGTA|POG-related WGTA generally involves collecting biopsy samples, applying whole-genome and transcriptome sequencing, and using bioinformatics analysis to interpret sequence data and inform clinical decision-making.
15837931|NCT04141397|Genetic|Usual care|Usual care, not involving the initiation of POG-related WGTA
15837932|NCT04141384|Device|Modular Interactive Tiles System, MITS|The modular robotic brick system was developed by Danish scholar Prof. Henrik Hautop Lund in collaboration with the University of Siena in Italy to develop a new tool. The system uses the design principles of different levels of daily life activities, combined with the way of cognitive games, Lego toys can combine different game concepts, with a set of individual or multi-person activity programs with hands or feet, provide a set Modular floor tiles for stroke patients and the elderly.
15837933|NCT04141371|Drug|Molar Sodium Lactate|daily 3-hour infusion of sodium molar lactate during the vasospasm period
15837934|NCT04141371|Drug|physiological serum|daily saline infusion over 3 hours during the vasospasm period
15837935|NCT04141358|Diagnostic Test|Advanced ultrasound measurements|"Clinical interventions and procedures:
~Consent at 0 week
~Clinical data collection at 0 week
~Strain for native artery at 0 week
~Young's modulus for native artery at 0 week
~Intimal medial thickness for native artery at 0 week
~Ultrasound blood volume flow measurement at 0 week
~Vessel diameter at 0 week
~Blood pressure at 0 week
~BMI at 0 week
~Intra-operative blood volume flow measurement at AVF surgery time
~Strain for native artery at 6 weeks
~Young's modulus native artery at 6 weeks
~Intimal medial thickness native artery arteries at 6 weeks
~Ultrasound blood volume flow measurement at 6 weeks
~Vessel diameter at 6 weeks
~Blood pressure at 6 weeks
~BMI at 6 weeks"
15837936|NCT04141345|Diagnostic Test|cardiopulmonary exercise test|Patients performed an upright graded bicycle exercise using a personalized protocol or performed a motorized treadmill exercise using a modified Bruce protocol. Peak VO2 and peak respiratory exchange ratio (RER) were defined as the highest 30-second average value obtained during exercise. The anaerobic threshold (AT) was determined by V-slope method. The VE(minute ventilation)/VCO2 (carbon dioxide production) at AT was calculated as the average VE/VCO2 for 1 minute during AT and immediately after AT. If AT could not be determined, the lowest VE/VCO2 was determined by averaging the three lowest consecutive 0.5-minute data points.
15837937|NCT04141332|Diagnostic Test|EEG was recorded by EEG Machines|EEG was recorded by EEG Machines
15837938|NCT04141319|Drug|Ketorolac|30ml of local infiltration solution containing 60mg ropivacaine
15837939|NCT04141319|Drug|Ropivacaine|30ml of local infiltration solution containing 6mg ketorolac
15837940|NCT04141319|Drug|Epinephrine|30ml of local infiltration solution containing 0.1mg epinephrine
15837941|NCT04141306|Other|Administrative data|Evaluation of month and year of birth, sex, referent doctor and surgeon
15837942|NCT04141306|Other|Clinical data|Evaluation of diagnostic circumstances, vital status at last follow up
15837943|NCT04141306|Other|Histological data|Evaluation of Pathology report of thyroid surgery
15837944|NCT04141306|Other|Imaging data|Evaluation of scintigraphy, MRI, scan
15837945|NCT04141306|Other|Biological data|Evaluation of thyroglobulin, antithyroglobulin antibodies
15837946|NCT04141306|Other|Further treatment|Evaluation of surgery, radiotherapy, targeted therapy
15837947|NCT04141293|Procedure|alveolar recruitment|Alveolar recruitment is a procedure to re-expand collapsed lung regions with the transient increment in transpulmonary pressure.
15837948|NCT04141254|Other|Debriefing and educative components|The patient will receive early debriefing and enhanced educative components added to a standardized visit at one month
15837949|NCT04141254|Other|Without debriefing and educative components|Patient will receive a standardized visit alone (without debriefing and enhanced educative components ) at one month
15837950|NCT04141241|Drug|Ecklonia cava Phlorotannin|Drugs that have been administered prior to participation in this study that are not expected to affect the results of this study will be accepted at the investigator's discretion.
15837951|NCT04141215|Biological|BIOBank bone paste|BIOBank bone paste (PPT322)
15837952|NCT04141215|Biological|BIOBank cortico-cancellous bone powder|BIOBank cortico-cancellous bone powder (PPT6)
15837953|NCT04141189|Procedure|weekly|fetal surveillance frequency
15837954|NCT04141189|Procedure|bi-weekly|fetal surveillance frequency
15837955|NCT04141176|Device|Spiri+|CPAP Spiri+ will be weared during one night for each included patient.The validation of the CPAP Spiri+ algorithm will be in the first 10 patients and appreciation of overall clinical efficacy on the 10 last OSAS.
15837956|NCT04141163|Drug|Metformin|Metformin, 1,1 dimethylbiguanide, or systematic (IUPAC) name N,N-dimethylimidodicarbonimidic diamide, is an oral anti-diabetic medicine approved in the US by the FDA in 1994. It is marketed alone under the names metformin (generic), Glucophage XR, Riomet, Fortamet, Glumetza, Obimet, Gluformin, Dianben, Diabex, and Diaformin and in combination with other drugs under the names Actoplus Met, Metaglip, Glucovance, Janumet, Kombiglyze XR, and PrandiMet
15837957|NCT04141163|Drug|Placebo oral tablet|No therapeutic effect
15838063|NCT04140201|Drug|Simvastatin 40mg|Drugs that lower lipid level
15837958|NCT04141150|Drug|[18F]APN-1607|In this study, all patients will receive one injection of [18F]APN-1607, a PET radiopharmaceutical selective for fibrillar tau. For the injection, subjects will receive a target dose of 7 mCi IV as a bolus injection. [18F]APN-1607 injection will be followed by a 10 ml saline flush.
15837959|NCT04141137|Device|TricValve® System|The TricValve® Delivery System (catheter) with already pre-mounted biological heart valve is inserted from the femoral vein to access the inferior vena cava (IVC) and superior vena cava (SVC) of the heart under fluoroscopy guidance. The appropriately sized TricValve® is released at the implantation site and positions itself as per the anatomy - self expanding frame.
15837960|NCT04141124|Other|breathing exercise/HRV-biofeedback|5 min of relaxing breathing, coupled with biological feedback.
15837961|NCT04141124|Other|Relaxing Breathing|5 minutes of relaxing breathing guided by a computer helping to follow inspiration and expiration.
15837962|NCT04141124|Other|Control|5 minutes of reading fictitious biological medical results
15837963|NCT04141111|Device|Continuous Glucose Monitoring (CGM)|"On each visit (baseline, 4, 8, and 12 months), participants received an iPro2 CGM device (MiniMed Medtronic), placed according to the manufacturer's standard procedure. The iPro2 was used each time for 7-days. During this period, patients were asked to perform 4 SMBG measurements daily for calibration (fasting, lunch, dinner, and before bed). Patients received a diary to register food intake, physical activity and medication, SMBG values, and any diabetes-related event (extra consultations, phone calls, etc) in the previous 4 months.
~Each time, CGM data was interpreted by an expert clinician, and a report was delivered, within one week, to the respective healthcare team. This report was discussed together by the patient and one member of the healthcare team, either in consultation or by phone, agreeing on any necessary therapeutic changes. If necessary, extra consultations for nutrition, nursing, or education, were scheduled, to address specific needs identified during rCGM review."
15837964|NCT04141098|Device|All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device.|All patients meeting all inclusion criteria and no exclusion criteria will be considered for nucleus replacement surgery following a review by the Medical Advisory Board. Any patient meeting any of the three intraoperative exclusion criteria will receive an alternative standard of care therapy.
15837965|NCT04141085|Other|Endometrial biopsy|All groups will undergo a mock frozen embryo transfer cycle with an endometrial biopsy being performed as opposed to an embryo transfer
15837966|NCT04141072|Diagnostic Test|Shrunken Pore Syndrome|eGFR Cystatin C ≤ 60% of eGFR Creatinine
15837967|NCT04141059|Dietary Supplement|Oligopin|Oligopin capsules composition is :100 mg Oligopin®, 150 mg Maltodextrin, 1.5 mg Mg stearate.
15837968|NCT04141059|Dietary Supplement|Placebo|Placebo capsules composition is: 250 mg Maltodextrin and 1.5 mg Mg stearate
15837969|NCT04141046|Device|XCSITE100 Stimulator - Individualized theta-tACS|20 second ramp-in and ramp-out with 40 minutes of stimulation for a total of 2440 seconds of stimulation
15837970|NCT04141046|Device|XCSITE100 Stimulator - Individualized alpha-tACS|20 second ramp-in and ramp-out with 40 minutes of stimulation for a total of 2440 seconds of stimulation
15837971|NCT04141046|Device|XCSITE100 Stimulator - Active Sham|20 seconds of ramp-in to 40 seconds of 10 Hz tACS with a ramp out of 20 seconds for a total of 80 seconds of stimulation
15837972|NCT04141033|Diagnostic Test|assessment of neopterin levels|neopterin is a macrophage biomarker used for diagnosis of active periodontitis and the response to treatment
15837973|NCT04141020|Procedure|Microsurgical clipping|Standard of care microsurgical clipping of an unruptured cerebral artery aneurysm.
15837974|NCT04141020|Procedure|Endovascular treatment|Standard of care endovascular treatment of an unruptured cerebral artery aneurysm.
15837975|NCT04141020|Drug|Sirolimus|Daily oral Sirolimus 2 mg tablets, adjusted as necessary per treating physician.
15837976|NCT04140994|Device|rTMS device|Participants will participate in 1 session of neuronavigated (TMS Navigator, Localite, Schloss Birlinghoven, D-53757, Sankt Augustin, Germany ) iTBS (patterned form of TMS) coupled with motor learning.
15837977|NCT04140981|Device|ultrasounography|in preoperative period, airway ultrasounagraphy for all patients will be made
15837978|NCT04140968|Drug|Utrogestan|300mg Utrogestan (1 tablet 100mg + 1 tablet 200mg) in the second and third menstrual cycle daily from cycle day 15 to 26.
15837979|NCT04140955|Procedure|Tapering plan and telephone counselling|Before discharge, a tapering plan is made in collaboration between the patient and one of the investigators. The telephone counselling will include guidance of the patient and/or adjustments of the tapering plan if needed.
15837980|NCT04140942|Behavioral|Virtual Reality Job Interview Training|Participants will engage in training related to preforming well during a job interview as well as repeated job interview practice with a virtual hiring manager. Participants will receive feedback and tips on improving skills throughout training.
15837981|NCT04140942|Behavioral|Services as usual|Study participants will be receiving Vocational Village services as usual that may include but is not limited to vocational skill training, daily living skill training, and social skill training.
15837982|NCT04140929|Other|Oral Health Tool Box|Please see, description of the intervention group
15837983|NCT04140916|Device|Midline catheter|Peripherally inserted short intravenous catheter
15837984|NCT04140916|Device|PICC-line catheter|Peripherally inserted long intravenous catheter
15837985|NCT04140903|Drug|Early transition to oral antibiotics|Patients will be treated with an oral antibiotic regimen (e.g. amoxicillin + metronidazole) based upon pharmacokinetic and pharmacodynamic properties of the drugs, pathogen susceptibility, and any existing drug allergies or interactions
15837986|NCT04140903|Drug|Standard treatment of intravenous antibiotics|Patients will continue standard intravenous antibiotic therapy for brain abscess (e.g. 3rd generation cephalosporin + metronidazole) according to international guidelines and pathogen susceptibility patterns.
15837987|NCT04140890|Behavioral|Habit Formation|Treatment sessions consist of 12 weekly health coaching sessions at participants' home. During the intervention period, an occupational therapist will help the participant to commit to developing new simple habits (dietary habits or physical activity habits) in each 60-minute session.
15837988|NCT04140890|Behavioral|Education|In the education group, participants will receive newsletters containing general healthy aging materials over 12 weeks. A trained research assistant will call participants to verify receipt of the newsletter, and answer their questions about the materials. Each phone call will last ~15 minutes.
15837989|NCT04140877|Device|Visu|An experimental (test) virtual reality display
15837990|NCT04140851|Dietary Supplement|Dietary fiber intervention|Dietary intervention
15837991|NCT04140851|Dietary Supplement|Normal diet|Normal diet
15837992|NCT04140838|Behavioral|Acceptance and Commitment Therapy (ACT)|Group treatment protocol of 8 weekly 90 minute sessions. Session 1: Presentation of the general concept of ACT therapy. Session 2: Value analysis I. Session 3: Value analysis II. Session 4: Value analysis III. Session 5: Values and feelings. Session 6: Taking a direction. Session 7: Dare and change. Session 8: Ready to act with ACT.
15837993|NCT04140838|Behavioral|Behavioral Activation Therapy for Depression (BATD)|"Group treatment protocol of 8 weekly 90 minute sessions. Session 1: Collection of information regarding areas of activity and interaction contexts.
~Session 2: Identification of information related to depressive behaviours. Session 3 Obtaining complementary information regarding the characteristics of the history of patient interactions and any contexts.
~Session 4: Explanation of the hypotheses of problematic behaviour, its maintenance and change throughout the intervention.
~Session 5: Once the 10 target activities have been identified, a record is made to track and their progress weekly.
~Session 6: Discussion of what was obtained from the records in general and of the satisfaction obtained, and explanation of the contexts and reinforcers.
~Session 7: Psycho-education Session 8: New behaviours, the goals achieved and the maintenance of the weekly activity are inquired about."
15837994|NCT04140838|Other|Treatment as Usual (TAU)|Standard pharmacological treatment usually provided to patients suffering chronic pain and mild-moderate depression.
15837995|NCT04140825|Device|Resmon PRO FULL|Measurement of lung impedance by the Forced Oscillation Technique
15837996|NCT04140812|Diagnostic Test|mass spectrometry (LC-MS/MS)|Blood collection (5 drops) during newborn-screening (36-72h after birth) or postnatal hospitalization (<36h after birth). The blood sample will then be examined using mass spectrometry (LC-MS/MS) for 125 proteins.
15837997|NCT04140799|Device|vocal cord ultrasonography|assess vocal cord motion and recurrent nerve function by Transcutaneous laryngeal Ultrasonography in patients scheduled for anterior cervical spine surgeries
15837998|NCT04140786|Drug|Gentamicin Sulfate, Injectable|10mg/kg prepared from commercially available stock (typically Kabi Pharmaceuticals) by licensed pharmacists.
15838001|NCT04140760|Other|Symprove|A liquid probiotic
15838002|NCT04140760|Other|Symprove placebo product|An inert placebo
15838003|NCT04140734|Device|Spacer Graft|In this prospective, randomized clinical trial, patients who will already be undergoing lower eyelid retraction repair with a spacer graft will randomly be assigned via a randomization web-site to receive 1 of 3 spacer grafts: hard palate, autologous auricular cartilage, and porcine acellular dermal matrix (Enduragen). Both the patient and the surgeon will know which of the three possible grafts are being used.
15838004|NCT04140721|Drug|Placebo oral tablet|Placebo pill identical to moxonidine administered for 4 weeks
15838005|NCT04140721|Drug|Moxonidine Pill|Moxonidine pill administered for 4 weeks
15838006|NCT04140708|Behavioral|Exercise--Rock Steady Boxing class|Rock Steady Boxing is a class designed specifically for those with Parkinsonism and movement difficulty using explosive and fine tuned movements as well as cognitive learning skills.
15838007|NCT04140695|Drug|Tradipitant|BID
15838008|NCT04140695|Drug|Placebo|BID
15838009|NCT04140682|Device|PAV+ mode|PAV+ mode by using Puritan-Bennett 840 ventilator
15838010|NCT04140682|Device|PSV mode|PSV mode by using Puritan-Bennett 840 ventilator
15838011|NCT04140669|Device|Automated Myocardial Performance Index (MPI)|Automated Myocardial Performance Index will be performed using Samsung HERA W10 prior too fetal surgical interventions, during surgery, and following surgery.
15838012|NCT04140656|Other|Plantar sensitive exercises|"Plantar sensitive exercises:
~40 minutes / 3 days per week / 8 weeks Warm up exercise (5 minute) Walking on different 4 different textured floors and hot floor (15 minute) Trying to recognize small objects with the soles of the feet (5min) Seated work with barbed ball and balance pad (5min) Massage to the sole of the foot with different textured fabrics (5min) Cooling exercise (5 min)"
15838013|NCT04140656|Other|Textured insole|"Textured insole group.
~Plantar sensitive exercises with insole 40 minutes / 3 days per week / 8 weeks (all exercises will be done with insoles) Warm up exercise (5 minute) Walking on flat ground (15 minute) Exercise with roller under the sole of the foot (5 minute) Seated work with barbed balance pad (5 min) Dorsi flexion and plantar flexion and hip flexion exercises (5min). Cooling exercise (5 min)"
15838014|NCT04140643|Device|Ozonated water delivering device effects on the oral health of pregnant women|Oral Hygiene instructions and use of an ozonated water delivering device in pregnant women for a period of 75 days.
15838015|NCT04140643|Behavioral|Oral hygiene instructions|Oral Hygiene instructions
15838016|NCT04140630|Other|No intervention|No intervention; 1 week observational study
15838017|NCT04140617|Behavioral|Exposure to aerosol of electronic cigarette|Exposure to aerosol of electronic cigarette (30 min)
15838018|NCT04140604|Other|Lactobacillus salivarius AP-32|Infants will be given the content of one capsule (mixed in infant formula or breast milk) twice daily (morning and evening) for 15 weeks.
15838019|NCT04140604|Other|Bifidobacterium lactis CP-9|Infants will be given the content of one capsule (mixed in infant formula or breast milk) twice daily (morning and evening) for 15 weeks.
15838020|NCT04140604|Other|Placebo|Infants will be given the content of one capsule (mixed in infant formula or breast milk) twice daily (morning and evening) for 15 weeks.
15838021|NCT04140591|Drug|Proton-pump inhibitor|PPI: Pariet EC 20mg/QDAC
15838022|NCT04140591|Drug|Propranolol+Proton-pump inhibitor|Propranolol 10mg BID initially and titrate dosage every week to achieve 25% drop of heart rate (keep heart rate>55 or systemic blood pressure >90mmHg) PPI: Pariet EC 20mg/QDAC
15838023|NCT04140578|Drug|Ertapenem|inject from iv drip before endoscopic cyanoacrylateinjection obliteration
15838024|NCT04140539|Biological|OTL-101|Autologous CD34+ cell enriched population that contains hematopoietic stem and progenitor cells (HSPCs) transduced ex vivo using a lentiviral vector (LV) encoding the human adenosine deaminase (ADA) gene.
15838025|NCT04140526|Drug|ONC-392|ONC-392 will be given by intravenous infusion, once every 21 days (Q3W).
15838026|NCT04140526|Drug|Pembrolizumab|Pembrolizumab will be given intravenous (IV) infusion at 200 mg/cycle, once every 21 days (Q3W).
15838027|NCT04140526|Drug|Osimertinib|Osimertinib will be given orally 80 mg, once a day.
15838028|NCT04140513|Radiation|Fludeoxyglucose F-18|Given via injection
15838029|NCT04140513|Procedure|Positron Emission Tomography|Undergo dPET
15838031|NCT04140487|Drug|Azacitidine|Given IV
15838032|NCT04140487|Drug|Gilteritinib|Given PO
15838033|NCT04140487|Drug|Venetoclax|Given PO
15838034|NCT04140474|Device|Archimedes procedure|All patients will initially have a scanner necessary for planning by the Archimedes system of the tunneling path. each patient will then undergo a general anesthesia as for any bronchoscopy. Then start the Archimedes procedure itself to reach the SPN
15838035|NCT04140461|Drug|Amphotericin B|The trial group and the control group received AmB 0.5mg/kg for 4 weeks and 0.7mg/kg for 2 weeks respectively.
15838036|NCT04140461|Drug|Flucytosine|The trial group and the control group received 100mg/kg for 4 weeks and for 2 weeks respectively.
15838037|NCT04140448|Drug|Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]|Intravitreal injection of Ranibizumab 0.5 MG/0.05 ML
15838038|NCT04140448|Device|Ultra-wide Fluorescein Angiography|Ultra-wide-field Fluorescein Angiography can clearly observe the peripheral retina
15838039|NCT04140435|Device|EUS-guided through-the-needle microbiopsy forceps (Moray)|"EUS-TTNB procedure technique. An endosonographer of each institution will perform the EUS procedures. Cysts morphology will be recorded and then punctured by using a 19-gauge EUS-FNA needle. Then the through-the-needle microbiopsy forceps (Moray) will be inserted through the needle into the cystic lumen. Microbiopsies will be obtained from the cyst wall randomly and from mural nodules or septae when observed. The open jaws of the forceps will be pushed onto the cyst wall, closed and pulled back to cause visible tenting. Two bites per pass will be obtained. Then the forceps will be removed and the specimen placed in formalin vials. The procedure will be repeated 2 times, or until 2 visible specimens are obtained. After completion of biopsies, the cyst fluid will be completely aspirated and sent for CEA, amylase, glucose and cytology analyses. If a mural nodule is visualized on EUS, it will be accessed separately by using the 19-gauge needle for EUS-FNA cytology."
15838040|NCT04140422|Other|Hyperosmolar eye drops|Application of one preservative-free hyperosmolar eye drop, when waking up and one eye drop 30 min later to one eye by the investigators
15838041|NCT04140422|Other|Placebo|Application of one preservative-free lubricating eye drop, when waking up and one eye drop 30 min later to the fellow eye by the investigators
15838042|NCT04140409|Drug|Sandostatin|All patients will be treated with octreotide LAR intramuscular injections at maximum doses of 60 mg every 4 weeks or a frequency up to 30 mg octreotide LAR each 2 weeks. Change of dose or frequency is left at the discretion of the investigator until symptom control is obtained.
15838043|NCT04140396|Drug|Saline infusion|Normal saline infusion at 10mL/hour
15838044|NCT04140396|Drug|Lidocaine infusion|Lidocaine infusion at 1.0mg/kg/hr
15838045|NCT04140383|Procedure|Cataract Surgery|Cataract surgery was performed by using phacoemulsification technique, routinely. But other techniques for instance extra or intracapsular cataract extraction (ECCE, ICCE) techniques were performed when needed. Phacoemulsification technique was performed by 2 experienced surgeon (G.A. and E.C.) under topical anesthesia, thorough limbal incision. Foldable single piece hydrophobic acrylic intraocular lens (IOL) was inserted in the bag. In the presence of complications related to anterior or posterior capsules, 3 pieces IOL was preferred. When ECCE technique was chosen, single piece polymethyl methacrylate IOL was inserted.
15838046|NCT04140370|Other|There is no intervention|There is no intervention
15838047|NCT04140344|Other|Text Message Group|The intervention group will receive automated text messages every day for the first week, and every other day for the second week post-operatively. The text messages will follow a series of pre-defined standardized scripts (Appendix 3) with embedded hyperlinks to a video from the providers with further advice. The patient is directed not to respond to the text messages, but to call for any questions or concerns. The text message group will receive a 30-day post-operative phone call to evaluate: number of ED visits, hospital readmissions, and to re-administer the questionnaires completed at baseline visit. Other data to be collected may include the following: number of phone calls to provider, MyChart messages to provider, pain medications, and new problems like pain and infection.
15838048|NCT04140331|Device|Accelerometer|Patient will wear the accelerometer for 7 consecutive days to measure the level of physical activity.
15838049|NCT04140318|Drug|sintilimab|Sintilimab 200mg, iv, 30-60min, q3w;
15838050|NCT04140318|Drug|nab-paclitaxel|Nab-paclitaxel: 125 mg/m2 iv d1、d8, q3w
15838051|NCT04140305|Drug|RPC-1063|Oral capsule
15838052|NCT04140292|Drug|Photodynamic therapy (PDT)|"PDT is a technique that combines a photosensitizing drug and an intense light source to kill tumor cells
~Noninvasive fluorescence dosimetry may be performed on up to 6 lesions. Levulan Kerastick will be applied to each lesion and left to incubate for 30 minutes. Blue light (Blu-U device, 20 J/cm2, 33 minutes) will be administered."
15838053|NCT04140292|Drug|Vitamin D3|"D3 pills (10,000 IU each) to be taken daily at home, beginning at either day -5 or day -14, as per their assignment
~Participants will receive a 5-day or 14-day supplementation of Vitamin D10,000 IU depending on their baseline Vitamin D 25 Hydroxy result"
15838054|NCT04140279|Drug|Latanoprostene Bunod|Ophthalmic solution
15838055|NCT04140279|Drug|Placebo|Ophthalmic solution, no active ingredient.
15838056|NCT04140266|Drug|Dapivirine (DPV) Vaginal Ring (VR)-004|Vaginal ring containing 25 mg of DPV
15838057|NCT04140266|Drug|Truvada Tablet|Oral tablet containing 200 mg emtricitabine (FTC)/300 mg tenofovir disoproxil fumarate (TDF)
15838058|NCT04140253|Behavioral|Pelvic floor muscle training (PFMT) with lumbopelvic stabilization|"Pelvic floor muscle training (PFMT) with lumbopelvic stabilization.
~Educating of probands about anatomy, physiology, and pelvic floor muscles functions
~Training of pelvic floor muscles in different position
~Training of pelvic floor muscles with lumbopelvic stabilization
~Exercise 5 times a week for 20-30 minutes a day, after initial training with a physiotherapist."
15838059|NCT04140240|Behavioral|intervention group|Parallel Assignment a experimental design with pre test and post test
15838060|NCT04140227|Drug|NOV03|100% Perfluorohexyloctane
15838061|NCT04140214|Drug|Hypertonic saline|Nebulized hypertonic saline solution (6%)
15838062|NCT04140214|Drug|Carbocysteine 750 MG|Carbocisteine tablet
15838066|NCT04140188|Diagnostic Test|Senti-Scint (99mTc- pertechnetate combined with human albumin)|Senti-Scint will be injected via intradermal route to the breast with history of previous NSM.
15838067|NCT04140162|Drug|Daratumumab|"Induction: 16 mg/kg actual body weight IV weekly (weeks 1-8; total of 8 doses) then every 2 weeks (weeks 9-24; total of 8 doses).
~Consolidation: 16 mg/kg actual body weight IV every four weeks (weeks 25-36)
~Maintenance: 16 mg/kg actual body weight IV every eight weeks (weeks 37-88)"
15838068|NCT04140162|Drug|Lenalidomide|"Induction: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 1-24)
~Consolidation: 25 mg PO once daily, on days 1-21 of each 28-day cycle (weeks 25-36)
~Maintenance: 10 mg PO once daily, on days 1-21 of each 28-day cycle until progression or intolerance
~Maintenance: 10 mg PO once daily, on days 1-21, weeks 37+ until progression"
15838069|NCT04140162|Drug|Bortezomib|Consolidation: 1.5 mg/m2 SQ on day 1, 8, 15 and 22 of each 28-day cycle (weeks 25-36)
15838070|NCT04140162|Drug|Dexamethasone|Induction and Consolidation: 40 mg (or reduced dose of 20 mg) PO or IV weekly
15838071|NCT04140149|Behavioral|Living with Hope|12-week, CBT-based, psychoeducational skills class
15838072|NCT04140136|Dietary Supplement|Tocotrienols|Tocotrienols as a potent antioxidant to modulate oxidative stress and inflammatory response
15838073|NCT04140136|Dietary Supplement|Placebo|The placebo is similar in appearance, but does not contain tocotrienols and consist of palm oil
15838074|NCT04140123|Drug|ZSP1601|ZSP1601 tablets be taken orally for 28 days.
15838075|NCT04140123|Drug|ZSP1601 Placebo|Subjects will receive matching placebo of ZSP1601
15838076|NCT04140110|Other|Intensive BP lowering|The aim is to achieve a systolic BP level of <120mmHg within 1 hour after randomisation and to maintain this BP level for the next 72 hours (or until hospital discharge or death if this should occur earlier).
15838077|NCT04140097|Other|Prospective monitoring of a large variety of parameters|Patients will be recruited during an inpatient pulmonary rehabilitation program. This setting offers a unique opportunity to study the phenomenon of an acute exacerbation of the Chronic Obstructive Pulmonary Disease prior to the first visible clinical sign and further on to have a follow up of the underlying mechanisms. All COPD patients that are referred to the reference center for a rehabilitation program will be included after providing written informed consent. Prospectively, a wide range of measurements will be collected. If a patient develops an acute exacerbation there will be a comprehensive diagnostic assessment to differentiate between pulmonary, cardiac or cardio-pulmonary reasons for the exacerbation. The clinical diagnosis of an AECOPD will be made by a pulmonologist according to criteria of international guidelines within the first 24h of clinical symptoms suggestive of an exacerbation.
15838078|NCT04140084|Device|Real-life clinical meetings|Study coordinators will identify potentially eligible parent/patient dyads and adult patients based on a chief complaint related to head trauma recorded at the time of ED registration and communication with treating clinicians in realtime. After using the decision aid with their health professional, a cognitive interview session will then be organized with the dyads of participants (parents/patients and clinicians) to address any usability issues. These interviews will be audio recorded and transcribed verbatim for content analysis and future reference. This process will allow to identify any conceptual barriers and unanticipated user needs. Written consent form will be signed by participants.
15838079|NCT04140058|Drug|Ondansetron|ondansetron was administered 20 minutes prior to spinal anesthesia.
15838080|NCT04140058|Drug|Normal saline|Placebo of 10 mL normal saline was administered.
15838081|NCT04140045|Other|Water intake|Water intake will be manipulated in both arms to create a hypohydrated state and a euhydrated state, post-exercise
15838082|NCT04140032|Behavioral|Multi-level preschool obesity control intervention|The multi-level intervention is a preschool-based program that integrates healthy nutrition and physical activity policies and practices into preschool operations via the Sesame Street Healthy Habits for Life curriculum. In addition to the curriculum, the intervention includes coaching sessions to enhance teacher lesson planning to routinely include nutrition and physical activity; as well as assist preschool site directors with implementing policy changes and parent engagement sessions.
15838083|NCT04140019|Diagnostic Test|CMR|Early CMR with adenosine stress/rest perfusion before invasive coronary angiography.
15838084|NCT04140006|Drug|ALN Gel|Flapped surgery for insertion of dental implant with topical application of ALN gel
15838085|NCT04140006|Drug|BMP Gel|Flapped surgery for insertion of dental implant with topical application of BMP gel
15838086|NCT04140006|Drug|Mixed Gel|Flapped surgery for insertion of dental implant with topical application of mixed gel of ALN and BMP
15838087|NCT04140006|Drug|Control|Flapped surgery for insertion of dental implant without topical application of any gel
15838088|NCT04139993|Biological|RBX7455|To evaluate intratumoral immunomodulatory effects of RBX7455 in operable breast cancer patients, tumor tissue samples from the diagnostic biopsy prior to RBX7455 and surgical specimen after RBX7455 treatment will be utilized.
15838089|NCT04139980|Other|Virtual Reality (VR)|Each VR session is 30 minutes long. Participants are able to pause or discontinue at any time. Each participant will receive one VR sessions five times per week over the course of a two-week period.
15838090|NCT04139967|Radiation|Short course radiation therapy|25 Gray in 5 fractions over 5-7 days
15838091|NCT04139954|Other|There is no intervention in the study|There is no intervention in the study
15838092|NCT04139941|Diagnostic Test|Test for HCV antibodies with an RDT|Fingerstick whole blood, plasma and serum of each participant is tested with three investigational HCV RDTs and one reference HCV RDT. Plasma is also used for testing with the composite reference standard, HCV viral load and genotyping. All participants are also tested for HIV with an HIV RDT.
15838093|NCT04139928|Dietary Supplement|Picometer-ionic form of magnesium chloride|Single-dose (300 mg) of the picometer-ionic form of magnesium chloride
15838094|NCT04139928|Dietary Supplement|Magnesium citrate or magnesium oxide|Single-dose (300 mg) of magnesium citrate or magnesium oxide
15838095|NCT04139928|Dietary Supplement|Placebo|Placebo
15838096|NCT04139915|Drug|Dactolisib|TORC1 inhibitor
15838097|NCT04139915|Drug|Placebo|Placebo capsule
15838144|NCT04139512|Procedure|guided surgery|placement of implant with local anesthesia using full guided surgery protocol versus free- hande one
15838145|NCT04139512|Procedure|conventionnel implant placement|placement of dental implant with conventionnal freehand technic
15838673|NCT04135274|Diagnostic Test|Neutrophil to lymphocyte ratio|Neutrophil to lymphocyte ratio
15838098|NCT04139902|Drug|Dostarlimab (TSR-042) (singly)|"If patients are randomized to Dostarlimab (TSR-042) alone, during the Pre-operative Phase, 500mg will be administered through an IV over 30 minutes, on Cycle 1 Day 1, and then again on Cycle 2 Day 1.
~Surgery will occur 1-4 weeks after completion of the pre-operative phase.
~During the Post-operative phase, Dostarlimab (TSR-042) 500mg will be administered through an IV over 30 minutes for 4 cycles every 3 weeks (Cycles 3-4), and then 1000mg will be administered through an IV over 30 minutes every 6 weeks (Cycles 5-10) for approximately 48 weeks."
15838099|NCT04139902|Drug|Dostarlimab (TSR-042) and TSR-022 (combination)|"If patients are randomized to the combination, Dostarlimab (TSR-042) and TSR-022, during the Pre-operative Phase, Dostarlimab (TSR-042) 500mg and TSR-022 300mg will be administered through an IV over 30 minutes on Cycle 1 Day 1 and then again on Cycle 2 Day 1.
~Surgery will occur 1-4 weeks after completion of the pre-operative phase.
~During the Post-operative Phase, Dostarlimab (TSR-042) 500mg will be administered through an IV over 30 minutes for 4 cycles every 3 weeks (Cycles 3-4) and then 1000mg will be administered through an IV over 30 minutes every 6 weeks for 6 doses (Cycles 5-10) for approximately 48 weeks."
15838100|NCT04139889|Diagnostic Test|Confocal Laser Endomicroscopy|"Confocal laser microendoscopy (CLE) as a new non-invasive imaging technique can be used for optical biopsy, which can perform real-time microscopic information of tissue in vivo at cellular level with resolutions up to 1μm and magnifications up to 1000 times. CLE is now being increasingly used with very promising results in gastroenterology, especially in the diagnostic investigation of Barret's esophagus, stomach cancer, colorectal cancer and various lesions of the biliary tract. With an intravenous injection of fluorescein, probe-based CLE (pCLE: GastroFlex probe with the Cellvizio laser system, Mauna Technologies, Paris, France) allows us to view the interstitial spaces, cells, and small capillaries in a window of 240 μm and to a depth of 60 μm."
15838101|NCT04139876|Procedure|Open Haemorrhoidectomy|Patient operated in the lithotomy position. The external components are grasped by clamps using gentle traction. Diathermy is used for dissection and hemostasis. The skin is incised midway to one-third of the distance from the top of the pedicle, thus, minimizing the skin excision. The subdermal fascia continuing into a submucosal fascia covering the internal anal sphincter is identified as are fibers passing between the hemorrhoid (H) and this fascia. The H is dissected free from the underlying internal sphincter in this plane, leaving the sphincter unharmed. The anal mucosa is incised at the transition from anal mucosa to hemorrhoidal mucosa and only anal mucosa overlying the H is excised. Only the caudal part of the H is excised. With the H held with gentle traction it is divided at the anal orifice. There will thus be a residual part of the H intra-anally with its caudal end 1-2 cm proximal to the anal orifice.
15838102|NCT04139876|Procedure|LigaSure Hemorrhoidectomy|Patient is operated in the lithotomy position. The main haemorrhoidal (H) masses are identified and delineated. The H are prolapsed out from the anal canal with Allis clamps or similar pick up forceps. Tension is applied to visualise the junction between the nodule and the mucosal wall (internal) or the perianal tissue (external). A small V-shaped anodermal seal is performed by applying the LigaSure (LS) forceps close to the edge of each pile. The seal is then transacted with scissors along the line of coagulum. Care should be taken to limit the amount of tissue removed to minimize the stricture risk. Repeated applications of the device are performed and the excision is continued into the anal canal, lifting the pile from the internal anal sphincter to the level of the vascular pedicle that is finally sealed by LS and divided.
15838103|NCT04139863|Diagnostic Test|aMMP-8 chairside test|No test
15838104|NCT04139850|Drug|Discontinuation of antiviral treatment in chronic hepatitis B cohort patients|For the selective patients in the cohort with long-term antiviral therapy and with conditions such as HBeAg negative or loss more than one year, antiviral therapy is able to be discontinued with an intensive inspection who agreed to the process. If there are need of this intervention, another multicenter IRB approval will be taken.
15838105|NCT04139837|Behavioral|Health screening, community health talks or activities on frailty|Screening for frailty using the FRAIL scale to categorize participant's status as robust, prefrail and frail. A series of community health talks or activities on frailty will be provided to each category of participants for the prevention or management of frailty.
15838106|NCT04139824|Drug|Xanthine Oxidase Inhibitor|LC350189 200mg qd
15838107|NCT04139824|Drug|nonsteroidal anti-inflammatory drug|Naproxen 500mg BID
15838108|NCT04139811|Other|Pars Plana Vitrectomy|vitrectomy with and without ILM peeling
15838109|NCT04139798|Drug|NOV03|100% Perfluorohexyloctane
15838110|NCT04139798|Drug|Placebo|Saline solution (0.6% sodium chloride solution)
15838111|NCT04139785|Other|Moodbuster|"Moodbuster intervention comprises three elements: (1) a web-based interface providing the patients access to CBT therapies, (2) a web-based portal for the trial co-ordinator and researchers, where they can view participation, amend modules and send login codes, (3) a mobile phone component which enables daily EMA monitoring of mood state, cognitions, activities, social interaction, and sleep.
~The mobile application will be used to capture EMA data."
15838112|NCT04139772|Drug|Docetaxel|Docetaxel 75 mg/m2 intravenous (iv) infusion every 3 weeks plus oral prednisone 5 mg twice daily for a maximum of 10 cycles.
15838113|NCT04139772|Drug|Abiraterone Acetate or Enzalutamide|"Patient will receive Abiraterone or Enzalutamide based on previous treatment.
~Abiraterone given orally at the dose of 1000 mg daily plus oral prednisone 5 mg twice daily until progression or unacceptable toxicity. One course of therapy corresponds to four weeks of treatment.
~Enzalutamide given orally at the dose of 160 mg daily until progression or unacceptable toxicity. One course of therapy corresponds to four weeks of treatment."
15838114|NCT04139759|Other|hand massage|In the hand massage group (n = 28), hand massage was applied to the hand without fistula for 8 minutes, 3 times a week, for 4 weeks.
15838115|NCT04139759|Other|foot massage|Foot massages were applied to both feet of the patients in the foot massage group (n = 28), 3 times a week, for 4 weeks and patting and kneading movements were repeated 3-4 times.
15838116|NCT04139746|Procedure|Scleral Buckling|Limbal 360 degrees peritomy of the conjunctiva was performed and the four recti muscles were isolated with 4 silk threads 4-0. A width-2 mm silicone encircling band was placed and sutured with 5-0 mersilene on the 4 quadrants of the sclera. Anterior chamber paracentesis was performed, draining about 0.3 mL of aqueous humour, and a buckle (220, 501, 506, or 516; Mira, Waltham, MA, USA) was sutured over the break. In all cases, the drainage puncture was executed at a distance of 11 mm from the limbus, in the area of greatest amount of subretinal fluid. Soon after the drainage puncture, a balanced salt solution (BSS) injection was performed in order to compensate the escape of the subretinal fluid.
15838117|NCT04139746|Procedure|Drainage-Injection-Pneumoretinopexy|According to the location of the sub-retinal fluid, a quadrant-flap of conjunctiva was opened. Indirect ophthalmoscopy evaluation was also used intraoperatively to localize the break and the subretinal fluid drainage site: in this area a vicryl 6-0 thread was passed through the sclera, about 9-10 mm posteriorly from the limbus, to facilitate the surgical maneuvers. The drainage puncture was performed 11 mm posteriorly from the limbus, having attention not to perform it directly above the site of the retinal break. In detail, a 2 mm radial sclera incision was created with a 15° disposable knife. The incision was cautiously deepened down to the choroid, which was finally perforated by a lachrymal dilator having a blunt tip. Soon after beginning the subretinal fluid drainage, an injection of BSS was performed in the opposite quadrant of the sclera (4 mm from the limbus) in order to allow an optimal spillage of the subretinal fluid and to flatten the retina.
15838118|NCT04139733|Procedure|Prone positon|Prone position within 6 hours after randomization. Prone position for at least conservative hours per days during a minimum of 5 days.
15838119|NCT04139733|Procedure|Supine positon|Conventional supine position ventilation, no prone position.
15838120|NCT04139720|Behavioral|e-book|sexual harassment prevention via education e-book
15838121|NCT04139707|Device|Caring4Dementia|A mobile application administered for 30 days, which provides people caring for a person living with dementia with a useful and intuitive tool targeting communication skills.
15838122|NCT04139707|Other|White Paper|The White Paper group will receive a white paper (hard copy and electronically) on the principles of communicating efficiently with persons living with dementia.
15838123|NCT04139694|Dietary Supplement|Food plan with cinnamon supplementation|cinnamon twice daily plus follow Cardiometabolic diet
15838124|NCT04139694|Behavioral|Food plan without cinnamon supplementation|Cardiometabolic diet only
15838125|NCT04139681|Drug|A. Vogels Sore Throat lozenges|5 times 1 A. Vogels sore throat lozenges daily for 4 days
15838126|NCT04139668|Drug|Naltrexone 380 MG [Vivitrol]|Three 4ml intramuscular injections of naltrexone 380mg (Vivitrol) administered over 12 weeks (one injection every 4 weeks)
15838127|NCT04139668|Behavioral|Motivational Enhancement Therapy and Cognitive Behavioral Therapy|Weekly Motivational Enhancement Therapy and Cognitive Behavioral Therapy (MET/CBT), based upon the Brief Counselling for Marijuana Dependence Manual published by the Substance Abuse and Mental Health Services Administration (SAMHSA), for 12 weeks
15838128|NCT04139655|Drug|Colchicine 0.6 mg|Oral colchicine given at 0.6 mg 1 hour prior to surgery, then 0.6 mg twice daily starting on the night after surgery for 7 days or until discharge from hospital, whichever occurs earlier. For patient under 60kg in body weight, daily dose will be 0.6 mg once daily. Medical and surgical management of the participant will be carried out under each institute's standard clinical practice.
15838129|NCT04139655|Drug|Placebo oral tablet|Placebo oral tablet given at 0.6 mg 1 hour prior to surgery, then 0.6 mg twice daily starting on the night after surgery for 7 days or until discharge from hospital, whichever occurs earlier. For patient under 60kg in body weight, daily dose will be 0.6 mg once daily. Medical and surgical management of the participant will be carried out under each institute's standard clinical practice.
15838130|NCT04139642|Device|SimpleSway|"During the 9-month period each practitioner who receives the balance + weight device is asked to provide anonymous feedback via a kiosk regarding if the balance data influenced clinical decision making after every patient. The kiosk has four marked buttons indicating a 4-point Likert Scale, so the practitioner just presses one of the four buttons to indicate their agreement with the statement, The balance measurement influenced my clinical decision making with this patient. After 9 months, the devices are switched so that every practitioner who had a weight only device receives balance + weight device and vice versa. After the second 9-month period concludes all devices will be retrieved by study personnel, and participants will be asked to complete surveys regarding their experience and attend group feedback sessions regarding their experiences."
15838131|NCT04139629|Diagnostic Test|antichlamydial antibody test|At the first day of stimulation blood analyses for IgG, IgA and IgM (ELISA) to major chlamydial antigens (anti-C.trachomatis), major outer membrane protein (MOMP) and plasmid-encoded protein (pgp3) will be performed for patients found eligible for the study.
15838132|NCT04139629|Drug|treatment of infertility with ART|COS in gonadotropin-releasing hormone (GnRH) antagonist protocol with IVF/ICSI, fresh ET and, if no pregnancy occurred, frozen/thawed ET (for all embryos resulting from this COS) will be performed.
15838133|NCT04139603|Other|Lumbopelvic kinesio taping|"Kinesio tapes applied to the lumbopelvic region will stay 3 days. They will be removed from the site, and the skin will be checked and cleaned, and then reapplied for the next 3 days.
~An ergonomic education program will be given after the baseline measurements, and will last for 45-60 minutes. A brochure including ergonomic principles with images will also be provided."
15838134|NCT04139603|Other|Abdominal supported lumbopelvic kinesio taping|"Kinesio tapes applied to the lumbopelvic region and abdominal area will stay 3 days. They will be removed from the sites, and the skin will be checked and cleaned, and then reapplied for the next 3 days.
~An ergonomic education program will be given after the baseline measurements, and will last for 45-60 minutes. A brochure including ergonomic principles with images will also be provided."
15838135|NCT04139603|Other|Placebo tapng|"Placebo tapes (just like Kinesio tapes) applied to the lumbopelvic region without any tension will stay 3 days. They will be removed from the site, and the skin will be checked and cleaned, and then reapplied for the next 3 days.
~An ergonomic education program will be given after the baseline measurements, and will last for 45-60 minutes. A brochure including ergonomic principles with images will also be provided."
15838136|NCT04139590|Device|Panda|
15838137|NCT04139590|Device|Visual Analogue Scale - Original|
15838138|NCT04139577|Biological|Fecal Microbiota Transplant|FMT- Oral Study Drug, predetermined dosage and timings, up to 2 cycles
15838139|NCT04139564|Device|EaseVRx headset|EaseVRx is a virtual reality therapy intended to treat chronic pain
15838140|NCT04139564|Device|Active control VR sham program|VR, 2d visual wildlife scenes similar to some EaseVRx content
15838141|NCT04139538|Procedure|orthodontic treatment|Malocclusion will be treated with orthodontic appliances (fixed or removable)
15838142|NCT04139525|Biological|unfractionated heparin|A bolus of 30 I.U./kg at the start of hemodialysis, followed by 18 I.U./kg per every hour of hemodialysis.
15838143|NCT04139525|Biological|8% trisodium citrate|8% trisodium citrate in the dose of 150 ml/h.
15838674|NCT04135261|Drug|HBM4003|Intravenous (IV) administration
15838146|NCT04139499|Procedure|Drug-induced sleep endoscopy (DISE)|DISE involves administering anesthetic to a patient to simulate a sleep state, and then visualizing the upper airway using transnasal flexible endoscopy. Sites of obstruction at key locations including the adenoids, soft palate, lateral oropharynx, tongue base, and epiglottis can be identified.
15838147|NCT04139499|Procedure|High-resolution manometry (HRM):|After the necessary clinical information has been obtained (if obstruction is occurring at those levels and, if so, to what degree), a flexible high-resolution manometry (HRM) catheter will be passes through the contralateral nostril to record pressure along the length of the pharynx at those same sites.
15838148|NCT04139486|Procedure|combined EMBOTRAP II or III and Contact Aspiration|refer to title
15838149|NCT04139486|Procedure|Contact Aspiration alone|refer to title
15838150|NCT04139473|Procedure|Hepaticojejunostomy / Duct-to-duct anastomosis|
15838151|NCT04139460|Device|CRT-D|After randomization, devices will be implanted as soon as possible (within 2 weeks). The ICD will be programmed with anti-tachycardia pacing and shock therapy as per common praxis.
15838152|NCT04139460|Device|CRT-P|After randomization, devices will be implanted as soon as possible (within 2 weeks).
15838153|NCT04139434|Drug|LP-108|For the dose escalation phase, LP-108 will be given once daily at the following dose levels: 100 mg QD, 200 mg QD, 400 mg QD, 600 mg QD, 800 mg QD, 1000 mg QD.
15838154|NCT04139434|Drug|LP-108|For the dose expansion phase, LP-108 will be given once daily dose at the Recommended Phase 2 Dose (RP2D).
15838155|NCT04139421|Behavioral|Shinrin-Yoku|Shinrin-Yoku is a traditional Japanese practice of getting in touch with nature through walking in the forest in a relaxed way using all five senses.
15838156|NCT04139408|Device|Disposable Pulmonary Surgical Marker|The subjects will undergo Marker placement procedure, within 24h before VATS.
15838157|NCT04139395|Drug|68Ga-Citrate PET/MRI|Participants will be injected intravenously (IV) with 370 MBq of 68Ga Citrate. 45 -60 minutes after the radiopharmaceutical IV administration, whole body data acquisition at the PET/MRI suite will begin.
15838158|NCT04139395|Drug|67Ga-Citrate SPECT|67Ga-Citrate will be used as the radiotracer for a regular medical care SPECT scan
15838159|NCT04139395|Device|Positron Emission Tomography|Imaging with 68Ga-Citrate PET/MRI
15838160|NCT04139395|Device|Magnetic Resonance Imaging|Imaging with 68Ga-Citrate PET/MRI
15838161|NCT04139395|Device|SPECT|Imaging with 67Ga-Citrate radiotracer. SPECT scan will be conducted as part of regular medical care.
15838162|NCT04139382|Other|Telephone Consultation|A telephone consultation comprising clinical history, contraception planning, explanation of medical method of abortion
15838163|NCT04139382|Other|Face-to-Face Consultation|A face-to-face consultation comprising clinical history, contraception planning, explanation of medical method of abortion
15838164|NCT04139356|Procedure|Deep breaths|Patients will undergo a 6 minutes protocol. Baseline: 1 minute normal breaths. Intervention: 1 minute with 10 deep breaths, 1 each 6 secs. Pulse-oxymetry will be continuously recorded.
15838165|NCT04139330|Drug|NPC-06|Infuse NPC-06 intravenously
15838168|NCT04139304|Drug|Cyclophosphamide|Given IV
15838169|NCT04139304|Biological|Daratumumab|Given IV
15838170|NCT04139304|Drug|Doxorubicin|Given IV
15838171|NCT04139304|Drug|Doxorubicin Hydrochloride|Given IV
15838172|NCT04139304|Drug|Etoposide|Given IV
15838173|NCT04139304|Drug|Prednisone|Given PO
15838174|NCT04139304|Drug|Vincristine|Given IV
15838175|NCT04139304|Drug|Vincristine Sulfate|Given IV
15838176|NCT04139291|Other|Complex decongestive therapy phase 1|Complex decongestive therapy-phase 1 program consist of meticulous skin and nail care, manuel lymphatic drainage, compression bandages, and remedial exercises. All patients will receive manual lymphatic drainage for three times a week (Monday-Wednesday-Friday) during 4 weeks, 50 minutes a day (a total of 12 sessions) by a trained lymphatic massage therapist.
15838177|NCT04139278|Other|Observational|Observational retrospective study
15838178|NCT04139265|Diagnostic Test|biologic analysis (ferritinemia, transferrin saturation coefficient)|Each patient will follow a blood test in order to compare between ferritinemia and transferrin saturation coefficient in iron deficiency diagnosis
15838179|NCT04139252|Other|No intervention|No intervention
15838180|NCT04139239|Diagnostic Test|Coma Recovery Scale-revision|Patients were assessed by Coma Recovery Scale-revision to detect the DOC patients enrolled by clinicians.
15838181|NCT04139226|Drug|CC-11050|CC-11050
15838182|NCT04139213|Drug|buprenorphine/naloxone oral product|To treat opioid use disorder, buprenorphine/naloxone will be provided by a study pharmacist under a collaborative pharmacy practice agreement on a weekly or monthly basis, unless the care plan specifies greater frequency of pharmacy visit. The median expected dose of buprenorphine/naloxone (sublingual film or tablet) is 8 to 24 mg daily, and may be adjusted per the collaborative pharmacy practice agreement.
15838183|NCT04139213|Drug|injectable naltrexone|To treat opioid use disorder, injectable naltrexone will be provided by a study pharmacist under a collaborative pharmacy practice agreement on a monthly (injectable naltrexone) basis. The expected dose of injectable naltrexone will be approximately 380 mg. Injectable naltrexone will be dispensed and prepared by the pharmacist but administered by nursing staff for the pilot study.
15838184|NCT04139213|Other|Pharmacy maintenance addiction care|Patients randomized to the pharmacy study arm and on a stable dose of buprenorphine/naloxone or naltrexone will receive maintenance care at the pharmacy for up to three months. Patients will visit for check-ins with a pharmacist on a monthly, weekly, or more frequent basis, depending on the individual treatment plan. Patients on buprenorphine/naloxone will be dispensed their medication at study visits, whereas patients taking injectable naltrexone will be dispensed it monthly by the pharmacist. All patients will visit the pharmacy at least monthly for addiction care (assessment, toxicological testing).
15838185|NCT04139213|Drug|oral naltrexone|To augment care for patients receiving injectable naltrexone for the treatment of OUD and treat cravings that may arise before their scheduled injection, patients prescribed injectable naltrexone may be provided a several day supply of oral naltrexone by a study pharmacist under a collaborative pharmacy practice agreement. The expected dose of oral naltrexone will be approximately 25-50 mg daily.
15838246|NCT04138758|Drug|LABA/ICS|Long-acting beta2-agonist and Inhaled corticosteroids (LABA and ICS)
15838188|NCT04139187|Other|Combined training with power and strength exercises|"The training will be compose by power and strength exercises and divided in two days. One day with the exercises: vertical jumps, box jumps, sit-ups, back-extension and guided squat. The second with half squat jumps, high straight jumps, bounding jumps, drop jumps and sprint. Both days will be started with warm up on treadmill running lasting 5 minutes at 6.5-7.5 km/h.
~The training protocol includes 20 sessions with 2 sessions per week during 10 weeks (2 weeks to adaptation and others 8 to training with progression of load after 4 weeks)."
15838189|NCT04139174|Procedure|first premolar extraction and complete canine retraction.|measurements on panoramic radiograph will be done after first premolar extraction and complete canine retraction.
15838190|NCT04139161|Procedure|Q-Factor Intervention|The intervention period will consist of 12 training sessions across four consecutive weeks, with three training sessions held per week. If pain is not increased or reduced and Rating of Perceived Exertion is ≤12, the participant will progress to the next bout. If pain is increased from the pre-bout pain score, participants will repeat the bout, at the same workrate and Q-Factor settings. Following this fashion, participants will progress through three increasing Q-Factors for each given workrate; Q-Factor 1 (Q1, 192mm), Q2 (234mm), Q3 (276mm). After completing bouts of all three Q-Factors for a given workrate, workrate will be increased by 20 Watts and bouts at each Q-Factor will be repeated. For each training session, participants will complete bouts of cycling until 1) the maximum number of bouts (4 bouts) has been accomplished, 2) self-reported Rating of Perceived Exertion >12, indicating a transition to moderate physical activity, or 3) self-reported pain >5.
15838191|NCT04139148|Device|Ture Transcranial Direct Current Stimulation (tDCS)|Ture 1-2 mA current of tDCS intervention in patients' binary brain DLPFC areas(20 mm).
15838192|NCT04139148|Device|Sham Transcranial Direct Current Stimulation (tDCS)|Sham tDCS intervention in patients' binary brain DLPFC areas(20 mm).
15838193|NCT04139135|Drug|HLX10|neoadjuvant treatment phase：HLX10（4.5mg/kg/3w IV） +SOX, adjuvant treatment phase：HLX10（4.5mg/kg/3w IV）
15838194|NCT04139135|Drug|Placebos|neoadjuvant treatment phase：placebos（4.5mg/kg/3w IV） +SOX, adjuvant treatment phase：SOX
15838195|NCT04139122|Drug|SJP-0132|SJP-0132 is administered as an eye drop
15838196|NCT04139122|Drug|Placebo|Placebo is administered as an eye drop
15838197|NCT04139083|Procedure|LSC mesh suspension|Long mesh, a synthetic T-shaped mesh (Gynemsh, Ethicon, San Lorenzo, Puerto Rico), is delivered into the pelvic cavity. Bilateral mesh arms are extracted outside trocar wounds bilaterally to stabilize mesh position. The center piece is fixed to the cervix with 5mm ProTack screws (Covidien, New Haven, Connecticut). Fixation is strengthened with Stratafix 2-0 sutures (Ethicon, Norderstedt, Germany), followed by Tisseel fibrin sealant (Baxter, Deerfield, Illinois) for better hemostasis among surrounding tissues. An extraperitoneal tunnel is created along the left round ligament until reaching 2cm medial to the anterior superior iliac spine (ASIS). One arm of the long mesh is pulled out along the tunnel underneath round ligament and fixed with the fascia of oblique abdominis. The same procedure is repeated for the contralateral side. Bilateral round ligaments and the mesh arms are sutured continuously with Stratafix 2-0.
15838198|NCT04139083|Procedure|TVM|Transvaginal mesh kit is delivered into the pelvis via vagina route.
15838199|NCT04139070|Drug|Bleomycin|Electroporation in combination with systemically administered bleomycin
15838200|NCT04139057|Drug|EBV-specific TCR-T cell with anti-PD1 auto-secreted element|Patients were pre-conditioned with chemotherapy and infused with EBV-specific TCR-T cells with anti-PD1 auto-secreted element
15838201|NCT04139044|Procedure|Balance Exercise Training for Stable Ankle|Balance and hop stabilization exercises were administered for 30 minutes of each exercise session.
15838202|NCT04139044|Procedure|Balance Exercise Training for Unstable Ankle|Balance and hop stabilization exercises were administered for 30 minutes of each exercise session.
15838203|NCT04139031|Device|Ultrasonographic measurement of corrected flow time in carotid artery|Corrected carotid artery flow time is measured using 6-13 MHz linear probe on a portable ultrasound machine. On the two-dimensional image, the optimal image of the long-axis view is obtained at the left common carotid artery. The sample volume is placed on the center of the lumen, 2 cm proximal to the bulb, and a pulsed wave Doppler examination was performed while the Doppler beams were adjusted to ensure < 60° of angle for the best signal. Then, cardiac cycle time and carotid flow time is measured. Carotid flow time is measured between the upstroke of the flow tracing and the dicrotic notch, and it is corrected for pulse rate by dividing flow time by the square root of the cardiac cycle time to calculate corrected carotid artery flow time (flow time/√cycle time).
15838204|NCT04139018|Drug|Timolol Gel|Timolol nasal gel 0.1% will be prepared with a poloxamer gel (combination of poloxamer 188 and 407; pH adjusted to 4.5-6.5) and 0.5 ml applied to each nostril twice daily. The total daily dose would amount to 2 mg.
15838205|NCT04139018|Drug|Placebo Gel|Placebo gel is prepared with poloxamers and no active ingredients.
15838206|NCT04139005|Behavioral|Awareness|The program foundation targets attention and awareness skills that are integral to many conceptions of mindfulness.
15838207|NCT04139005|Behavioral|Connection|The Connection module targets skills underlying social connection, which refers to the sense of having close and positively experienced relationships with others in the social world.
15838208|NCT04139005|Behavioral|Insight|The Insight module targets skills underlying dynamic self-inquiry and experiential self-knowledge.
15838209|NCT04138992|Drug|bevacizumab|bevacizumab will be used during neoadjuvant and concurrent chemoradiotherapy
15838210|NCT04138992|Drug|DDP|DDP will be used during neoadjuvant and concurrent chemoradiotherapy
15838211|NCT04138992|Drug|Docetaxel|used in neoadjuvant chemotherapy
15838212|NCT04138992|Radiation|radiotherapy|standard treatment includes pelvic external beam radiation and brachytherapy
15838213|NCT04138979|Drug|cyclophosphamide|First use of chemotherapy after breast cancer
15838214|NCT04138966|Device|Nol-Index|Multiparametric monitor that studies that establishes an index as a surrogate to nociception
15838215|NCT04138966|Device|Skin Conductance|Measures skin conductance as a surrogate to nociception
15838216|NCT04138953|Device|Transcranial Magnetic Stimulation (TMS)|"Transcranial magnetic stimulation, also known as repetitive transcranial magnetic stimulation, is a noninvasive form of brain stimulation in which a changing magnetic field is used to cause electric current at a specific area of the brain through electromagnetic induction.
~It will be used to create a 'virtual lesion,' disrupting neural activity in a specific brain region to identify whether it is causally involved in a specific behavioral process."
15838217|NCT04138953|Other|Sham TMS|Sham Transcranial Magnetic Stimulation (TMS) over premotor cortex
15838218|NCT04138940|Behavioral|Script Training|Participant uses a computer program to practice scripts with a virtual therapist.
15838219|NCT04138927|Drug|Fostamatinib disodium|Fostamatinib is supplied in two (2) dosage strengths: 100 mg and 150 mg.
15838220|NCT04138914|Device|Focal Cryotherapy|Ablation of the cancer focus within the prostate using cryotherapy
15838221|NCT04138901|Procedure|Ultrasound guided subcostal transversus abdominis plane block (TAPB)|At the end of surgery, an anesthesiologist will perform bilateral subcostal TAP block with 0.375% ropivacaine 15ml at each site under ultrasound guidance.
15838222|NCT04138901|Drug|Ropivacaine 0.75% Injectable Solution|0.375% ropivacaine is injected to the transversus abdominis plane via 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)
15838223|NCT04138901|Device|21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)|0.375% ropivacaine is injected to the transversus abdominis plane via 21G 100 mm stimulator needle (Echoplex®, Vygon, Ecouen, France)
15838224|NCT04138888|Drug|Olmesartan Medoxomil/Hydrochlorothiazide 40 Mg/25 Mg film-coated tablets for oral use|Olmesartan Medoxomil/Hydrochlorothiazide is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 40 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.
15838225|NCT04138888|Drug|Olmetec® Plus 40 Mg/25 Mg film-coated tablets for oral use|Olmetec® Plus is manufactured by Daiichi Sankyo Europe GmbH, Germany. Each tablet contains 40 mg of olmesartan medoxomil and 25 mg of hydrochlorothiazide.
15838226|NCT04138875|Drug|Rituximab|Rituximab is dosed at 375mg/m2 as an intravenous infusion. No adjustments are necessary for hepatic or renal impairment. Dosing will be done on baseline weight and height, however in patients who experience a >10% change in weight dosing will be readjusted.
15838227|NCT04138875|Drug|Brentuximab Vedotin|Brentuximab vedotin is to be given as intravenous infusion at a dose of 1.2mg/kg during induction and 1.8mg/kg with each cycle. Dose reductions to 1.2mg/kg are allowed at investigator discretion.
15838228|NCT04138875|Drug|Bendamustine|Bendamustine is to be given intravenously at a dose of 90mg/m2 on day 1 and day 2 of each high risk cycle. Dose reductions to 60mg/m2 are allowed at investigator discretion.
15838229|NCT04138862|Behavioral|Product Labelling and Sensory modifications|the beverages varied in the label that was attached (no label or a 'Healthier Choice' label) and the sensory matching of the calorie reduction (sensory matched, reduced or enhanced).
15838230|NCT04138849|Drug|BBT-877 single dose|Oral capsule, single dose.
15838231|NCT04138849|Drug|Placebo single dose|Oral capsule, single dose.
15838232|NCT04138836|Drug|BBT-877|BBT-877 oral capsule.
15838233|NCT04138836|Drug|Midazolam|Midazolam oral syrup.
15838234|NCT04138836|Drug|Itraconazole|Itraconazole oral capsule.
15838235|NCT04138836|Drug|Esomeprazole|Esomeprazole oral capsule.
15838236|NCT04138823|Drug|BI 891065|Tablets
15838237|NCT04138823|Drug|BI 754091|Solution for infusion
15838238|NCT04138810|Other|VCE|Videoconference conducted according to a standard script which reviews the following key aspects of post-operative care: bowel functions, voiding functions, presence of vaginal bleeding, pain control, diet status, ambulatory status and any additional concerns. Standard post-operative instructions and precautions are reviewed as well.
15838239|NCT04138810|Other|Survey|Measure of satisfaction regarding post-op visit.
15838240|NCT04138797|Procedure|Electrophysiological exploration|Electrophysiological exploration is performed, as part of the routine care, after the Biosemi high density ECG, the same day or maximum 4 days later. It is performed in interventional rhythmology room, under fluoroscopic control. After local anesthesia, one or more introducers are placed in the femoral vein allowing the introduction of catheters. These catheters allow recording of the HV interval
15838241|NCT04138797|Device|ECG Biosemi|Non invasive ECG monitoring for HV measurement using high density Biosemi device. This device use 256 skin electrodes. At the same time and with the same system, a chest pressure sensor can record the patient's breathing movements.
15838242|NCT04138784|Other|Individualized comprehensive rehabilitation program|The program general contents were pain education, joint protection techniques, general care lifestyle habits, which were complemented by a problem-based session. The program plan was designed to fit patients' goals, priorities, and lifestyles after an initial interview.
15838243|NCT04138784|Other|Aquatic training|Patients received a 45 min-water exercise program which included balance and proprioception activities, isometric exercise, flexibility exercises, core stabilization exercises and aerobic/endurance exercises. All sessions were developed in groups and addressed by a qualified professional.
15838244|NCT04138771|Device|An artificial intelligence system for postoperative management of cataract patients|This system can detect multiple postoperative complications of cataract patients and then provide a management strategy.
15838245|NCT04138758|Drug|Tiotropium bromide + Olodaterol|Tiotropium bromide + Olodaterol
15838247|NCT04138745|Other|Transverse Thoracic Plane Block|A bilateral plane block in the transverse thoracic space
15838248|NCT04138732|Behavioral|Improve health behaviors of medical personel|This arm will receive the intervention treatment aimed to help improve their health behaviors, as determined by employee-based steering committee. Interventions will target nutrition, physical activity and stress reduction
15838249|NCT04138719|Drug|Nab-paclitaxel + Carboplatin|nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and carboplatin given IV at AUC 5 on days 1 every 21 days x 6 cycles;
15838250|NCT04138719|Drug|Nab-paclitaxel + Epirubicin|nab-paclitaxel given IV at 125 mg/m^2 on days 1, 8 and epirubicin given IV at 75 mg/m^2 on days 1 every 21 days x 6 cycles；
15838251|NCT04138706|Drug|Vancomycin|Extension of initial vancomycin regimen for the treatment of C. diff from 14 days to 28 days (i.e. an additional 14 days of vancomycin treatment)
15838252|NCT04138706|Drug|Placebos|Initial vancomycin treatment (x14 days) will be followed by 14 days of placebo.
15838253|NCT04138693|Device|G-PUR® 2x 2.0 g oral suspension|Cohort 1: 2 g G-PUR® powder mixed with 100 ml water in an opaque drinking bottle will be orally administered before and immediately after 204Pb intake
15838254|NCT04138693|Device|G-PUR® 1x 2.0 g oral suspension|Cohort 2: 2 g G-PUR® powder mixed with 100 ml water in an opaque drinking bottle will be orally administered before 204Pb intake and 100 ml water (placebo) in an opaque drinking bottle immediately after 204Pb intake
15838255|NCT04138693|Device|Placebo oral suspension|Cohort 3: 100 ml of water in an opaque drinking bottle will be orally administered immediately before and after 204Pb intake
15838256|NCT04138680|Behavioral|Active Biofeedback|"The active biofeedback session will be done within the 7T MRI. It will include a pre-training run, 3 training runs, and a post-training run. Each run will be comprised of MOTIVATE and REST trials. During each MOTIVATE trial, subjects will be instructed to generate a heightened state of motivation. Participants will be encouraged to identify strategies that are personally relevant or useful and to monitor the efficacy of the strategies. Subjects will simultaneously view a progress bar on the screen during MOTIVATE trials that represents their VTA activity and they will be trained to try to increase the level of the bar by motivating themselves. For the active VTA biofeedback group, the progress bar will be updated every second to accurately convey level of VTA signal activation. During REST trials, all subjects will be instructed to count backwards. During the post-training 'test' run, subjects will be instructed to use the strategies they found to be most effective."
15838257|NCT04138680|Behavioral|Sham Biofeedback|The sham biofeedback session resembles the active condition, however, the thermometer seen during the MOTIVATE trials will represent yoked sham values.
15838258|NCT04138667|Other|complex decongestive therapy|Complex decongestive therapy-phase 1 program consist of meticulous skin and nail care, manuel lymphatic drainage, compression bandages, and remedial exercises. All patients will receive manual lymphatic drainage for three times a week (Monday-Wednesday-Friday) during 4 weeks, 50 minutes a day (a total of 12 sessions) by a trained lymphatic massage therapist.
15838259|NCT04138654|Dietary Supplement|Processed meat product|300 grams per day during 2 weeks
15838260|NCT04138654|Dietary Supplement|White meat wash-out|300 grams per day during 2 weeks
15838261|NCT04138654|Dietary Supplement|Processed meat products enriched with natural compounds|300 grams per day during 2 weeks
15838262|NCT04138654|Dietary Supplement|Drinking water containing nitrate up to acceptable daily intake level (ADI = 3.7 mg/kg bw) in combination with 300 grams of processed meat, white meat or processed meat enriched with natural compounds|3.7 mg nitrate/kg bw per day plus 300 grams of meat for 1 week
15838263|NCT04138641|Drug|Cangrelor|Cangrelor intravenous
15838264|NCT04138628|Drug|Atezolizumab|The study drug will be given according to current recommendations as systemic treatment every third week for 12 months or until progression. Treatment will be initiated within 28 days of detection of ctDNA.
15838265|NCT04138615|Drug|Morphine|Subjects will receive Morphine while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.
15838266|NCT04138615|Other|Placebo|Subjects will receive saline while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.
15838267|NCT04138602|Device|BTL Emsella|Subjects will be asked to sit on the device and the height will be adjusted until the subject's feet are on the floor. The active treatments are individualized, since some subjects will be more sensitive than others. The Emsella Chair will be turned on and the setting gradually increased to the subject's sensory threshold; the maximum sensation the subject can tolerate. The setting will then be decreased slightly and stay unchanged for the remainder of the treatment time. The treatment threshold should be increased with every treatment until the subject reaches 100%.
15838268|NCT04138602|Device|Sham BTL Emsella|Sham subjects will be seated on the device in the same manner as the active treatment group. The sham treatment will provide some sensation without active HIFEM technology. The programming for the sham treatment will have an amplitude limitation, with the setting below the therapeutic level ( < 10 % power).
15838269|NCT04138537|Other|OB volume|The mean OB volume was calculated in cubic millimeters and compared between the two groups.
15838270|NCT04138537|Other|CCCRC test|CCCRC test was done for olfactory function assessment and compared between the two groups.
15838271|NCT04138524|Other|SAFIR©|Early Supportive intervention for families of patients with acquired brain injuries.
15838272|NCT04138511|Device|ECOFISIO|The ECOFISIO application is focused on sports pathologies and contains relevant written and digital information about ultrasound imaging and managing as well as diagnosis of sport injuries.
15838273|NCT04138498|Drug|Dexmethylphenidate 5 Mg Oral Capsule, Extended Release|Reference listed drug (RLD) for comparative BA evaluation
15838274|NCT04138498|Drug|Dexmethylphenidate 6.25 mg Tablet|Experimental drug for comparative BA evaluation
15838275|NCT04138498|Drug|Dexmethylphenidate 40 Mg Oral Capsule, Extended Release|Reference listed drug (RLD) for comparative BA evaluation
15838276|NCT04138498|Drug|Dexmethylphenidate 50 mg Tablet|Experimental drug for comparative BA evaluation
15838277|NCT04138485|Biological|IgPro10|10% liquid formulation of human immunoglobulin for IVIG
15838278|NCT04138485|Biological|Placebo|0.5% human albumin solution stabilized with 250 mmol/L L-proline
15838279|NCT04138472|Drug|dexmedetomidine|intravenous dexmedetomidine 0.06mg/kg in 100ml normal saline 0.9% over 10minutes.
15838280|NCT04138472|Drug|fentanyl|intravenous fentanyl at 2mcg/kg in 100ml saline over 10 minutes in induction room.
15838675|NCT04135235|Drug|TAF|Propofol tenofovir fumarate
15838281|NCT04138472|Drug|lidocaine|intravenous lidocaine 1.5mg/kg in 100ml saline over 10 minutes in induction room.
15838282|NCT04138459|Other|Not an interventional study. This is a qualitative, explorative study of recovery orientation of community mental health services|"Explore recovery orientation of mental health services in a municipality through:
~Qualitative, in-depth interviews with service users and mental health professionals and
~Observational fieldwork"
15838283|NCT04138446|Other|Altitude exposure in climate chamber|Altitude exposure in a climate chamber will consist of hypobaric hypoxia similar to the conditions found at 3000m asl and 5000m asl.
15838284|NCT04138433|Device|Real tDCS|Anodal tDCS 2 ma
15838285|NCT04138433|Device|Sham tDCS|Sham tDCS 2 ma
15838286|NCT04138420|Drug|Bevacizumab Injection|Three monthly intravitreal injections of bevacizumab (1.25 mg/0.05 mL)
15838287|NCT04138407|Other|seated Tai Chi|Seated Tai Chi is a redesigned short form of traditional Tai Chi, can be practiced in a chair or wheelchair
15838288|NCT04138407|Other|Usual rehabilitation exercise|Regular rehabilitation exercise used in participating hospital
15838291|NCT04138381|Drug|Selinexor|oral selinexor given once weekly (Cohort A), oral selinexor given BIW (Cohort B)
15838292|NCT04138381|Drug|Imatinib|imatinib 400 mg, once daily (Cohort A)
15838293|NCT04138368|Behavioral|dyadic psychotherapeutic intervention|Mothers and infants will be treated with dyadic psychotherapy focused on interactions, emphasizing eye contact, body language, empathy, and social reciprocity, using the principles of Interaction Guidance Therapy (Sameroff et al., 2004). Dyadic psychotherapy will be administered one time a week during the 8-week trial period, at the subject's home. Each session, approximately 90 minutes long, will include videotaping mother-infant interaction, watching the last session's interaction as a part of video-feedback technique, and discussing main issues in the mother-infant relationship. In addition, each session will begin and end with a- 5-minute episode of affectionate touch and gaze synchrony between the mother and her infant.
15838294|NCT04138368|Behavioral|supportive intervention|Supportive therapy: mothers will receive psychoeducational knowledge regarding the infants' development. The treatment will be administered one time a week during the 8-week trial period, at the subjects' home.
15838295|NCT04138355|Other|Extracorporeal shock wave therapy|ESWT was conducted using the Duolith SD-1® device (StorzMedical, Tägerwilen,Switzerland) with an electromagnetic cylindrical coil source for the focused shock wave. ESWT was performed around the primary treatment site at 100 impulses/cm2, an energy flux density(EFD) of 0.05 to 0.30 mJ/mm2, frequency of 4Hz, and 1000 to 2000 impulses were administered at 1-week intervals for 4 sessions.
15838296|NCT04138342|Drug|Quantum dots coated with veldoreotide|The active group will receive Quantum dots coated with veldoreotide in different topical dosage forms as an anti-cancer drug.
15838297|NCT04138342|Drug|Topical approved placebo|The placebo group will receive topical FDA approved in different dosage forms as a negative control drug.
15838298|NCT04138329|Procedure|Lichtenstein Technique|In this group was used the Lichtenstein technique for inguinal repair
15838299|NCT04138329|Procedure|Onstep Technique|In this group was used the Onstep technique for inguinal repair
15838300|NCT04138316|Drug|Candesartan|Treatment with Candesartan
15838301|NCT04138303|Other|Exercise Protocol|The exercise protocol consists of a nine-week progressive intense-conditioning program involving six consecutive days (Monday-Saturday) of one-hour exercises and one-day rest weekly for a total of 54 days of exercise. Exercises are performed in person as a group with other participating subjects and lead by certified instructors. Exercises will involve a variety of activities ranging from running, cycling, whole-body functional movements, power movements, and open-chain weight lifting with barbells and resistance bands.
15838302|NCT04138303|Other|Calorie-Restrictive Low Carbohydrate Diet (CR-LC)|Consists of weekly nutrition plans, counseling and monitoring by on-site registered dietitians and nutritionists for nine weeks. CR-LC consists of caloric and macronutrient restrictions. Caloric restrictions involves a 40% deficit from calculated total daily energy expenditure. Macronutrient restriction involves a high protein, low carbohydrate diet (35% protein, 25% carbohydrate and 40% fat).
15838303|NCT04138303|Other|Ancestral Diet (AD)|Consists of weekly nutrition plans, counseling and monitoring by on-site registered dietitians and nutritionists for nine weeks. AD consists of consuming only whole foods and avoiding processed foods. Emphasis will be on food quality with no caloric or macronutrient restrictions.
15838304|NCT04138290|Device|Predictix Antidepressant Software tool|Predictix Antidepressant is a stand-alone software tool based on a patients' genetic panel, clinical, demographic and behavioral inputs, intended to support a clinician in choosing the most suitable antidepressant treatment/s for an individual patient diagnosed with Major Depressive Disorder.
15838305|NCT04138277|Drug|AT2221|Participants received ATB200 co-administered with AT2221 (Miglustat)
15838306|NCT04138277|Biological|ATB200|Enzyme Replacement Therapy via intravenous infusion
15838307|NCT04138264|Other|Preoperative opioid counseling|preoperative counseling consists of education with a brief multi-media presentation in the preoperative area on the day of surgery using a handheld tablet. The message of the preoperative counseling consisted of: 1) Background on the opioid epidemic including basic facts and consequences, 2) Description of risk factors for opioid abuse and how to consume opioids safely, 3) Information on the specific opioid the patient was prescribed and the anticipated amount and duration of use postoperatively, 4) Encouraging the use of non-opioid therapy prior to taking the prescribed opioids or quickly transitioning to non-opioid medications postoperatively, and 5) Contact information and instructions to call if the patient experienced any adverse events and/or if additional pain medication is needed.
15838308|NCT04138251|Drug|Empagliflozin|oral administration of Empagliflozin
15838309|NCT04138238|Device|Supraflex Cruz Sirolimus-eluting Stent|Patient implanted with at least one Supraflex Cruz sirolimus-eluting stent as a part of planned clinical care
15838310|NCT04138212|Drug|Paclitaxel, Cisplatin|Paclitaxel 175mg/m2 plus Cisplatin 75mg/m2, q21d, 2 cycles
15838311|NCT04138212|Radiation|neoadjuvant chemoradiation therapy|Paclitaxel 50mg/m2 plus Carboplatin AUC=2, q1w, 5 cycles; 41.4Gy, 1.8Gy/d*23
15838312|NCT04138186|Device|2.0g G-PUR®, oral administration|tid for 12 weeks
15838313|NCT04138186|Device|Placebo, oral administration|tid for 12 weeks
15838314|NCT04138173|Behavioral|Tele coaching intervention|"A.Education about the importance of PA. During a one-to-one interview with the coach motivation, self-efficacy, barriers, favorite activities and strategies to become more active are discussed.
~B. Step counter providing direct feedback.
~C.A smartphone with a project-tailored application. The application provides automated coaching by displaying an activity goal (number of steps) and feedback on a daily basis. The feedback comes with a graphical presentation. Patients' targets are automatically revised weekly.
~D.Telephone contacts triggered in the case of non-compliance with wearing the step counter, failure to transmit data or failure to progress. Coaches are alerted by a note at the coaches' backend to take contact with the patient if needed."
15838315|NCT04138160|Other|5:2 Intermittent energy restriction|Substantial (70%) energy restriction for 2 non-consecutive days/week interspersed with normal energy intake (isoenergetic) on the remaining 5 days of the week.
15838316|NCT04138160|Other|Continuous energy restriction|20% energy restriction each day relative to the energy requirement.
15838317|NCT04138147|Procedure|Superficial cervical plexus with auriculotemporal nerve blocks|Superficial cervical plexus block using 10 ml bupivacaine 0.5%. Auriculotemporal nerve block using 3 ml bupivacaine 0.5%.
15838318|NCT04138147|Procedure|Cervical retrolaminar with auriculotemporal nerve blocks|Cervical retrolaminar block using 10 ml bupivacaine 0.5%. Auriculotemporal nerve block using 3 ml bupivacaine 0.5%.
15838319|NCT04138121|Device|Ultrasound|Ultrasound scan of the cricothyroid membrane
15838320|NCT04138108|Other|Psychoeducation|The parents of each child were educated as couples and each training session lasted 45-60 minutes for each family. Approximately the first five minutes of the training were used for warm-up, 25 minutes were used for basic ADHD knowledge and the last 15 minutes were catechetic and conducted interactively. The psychoeducation included discussion about the causes, symptoms and signs of ADHD, the course and characteristics of the disease according to age, the treatment process, the drugs used in the treatment and their side effects, correct and incorrect information about drugs, the other symptoms which can coexist with ADHD and their treatment, and what the parents can do about these issues.
15838321|NCT04138095|Device|Virtual Reality|Participants will have access to an Oculus Quest Virtual Reality Headset every second day as an alternative to opioids for pain management and benzodiazepines for anxiety management
15838322|NCT04138082|Other|Exposition to high-dB soundtrack|Already stated
15838323|NCT04138069|Other|PLB+Aerobic Bicycling|"Combination of Breathing control and Purse lips breathing technique for 5 minutes at the start of session.
~Purse lips breathing with aerobic bicycling for 8 minutes"
15838324|NCT04138069|Other|Aerobic Bicycling|"Breathing control for 5 minutes at the start of session.
~Aerobic bicycling for 8 minutes"
15838325|NCT04138056|Biological|RSVPreF3 formulation 3|One dose of RSVPreF3 formulation 3 vaccine administered intramuscularly in the left or in the non-dominant arm.
15838326|NCT04138056|Biological|RSVPreF3 formulation 2|One dose of RSVPreF3 formulation 2 vaccine administered intramuscularly in the left arm.
15838327|NCT04138056|Biological|Boostrix-ex-US|One dose of the dTpa (Ex-US formulation) vaccine administered intramuscularly in the right arm.
15838328|NCT04138056|Biological|Boostrix-US|One dose of the dTpa vaccine (US formulation) administered intramuscularly in the right arm.
15838329|NCT04138056|Drug|Placebo|One dose of placebo (NaCl solution) administered intramuscularly in either the left or the right arm.
15838330|NCT04138043|Drug|Placebo|Placebo is 0.9 percent sodium chloride solution. It will be administered as SC injection to abdomen by study personnel. Three injections will be used to match active doses.
15838331|NCT04138043|Drug|GSK2330811|GSK2330811 will be available as SC injection 150 mg/mL.
15838332|NCT04138030|Procedure|Conventional Endoscopic Mucosal Resection|Use of injected chromogelofusine solution to raise a lesion prior to polypectomy snare closed over a polyp with electrocautery
15838333|NCT04138030|Procedure|Cold Snare Endoscopic Mucosal Resection|Use of injected chromogelofusine solution to raise a lesion prior to polypectomy snare closed over a polyp without electrocautery
15838334|NCT04138017|Device|ViviGen|A cellular bone matrix which includes viable osteoblasts within a corticocancellous and demineralized bone carrier, represents a unique alternative to autograft or existing products which utilize mesenchymal stem cells.
15838335|NCT04138004|Drug|polyethylene glycol in combination with lubiprostone|2-litre polyethylene glycol split-dose in combination with one 24 mcg tablet of lubiprostone
15838336|NCT04138004|Drug|polyethylene glycol alone|4-litre polyethylene glycol split-dose
15838337|NCT04137991|Device|Nol-Index guided analgesia|Monitor that indicates the level of nociception-antinociception balance
15838338|NCT04137991|Other|Standard Analgesia|Administration of remifentanil based guided by heart rate, blood pressure, and experience
15838339|NCT04137978|Drug|ADV7103|Patients receive ADV7103 twice a day at optimal dose.
15838340|NCT04137978|Drug|Standard of Care|Cohort of patients with cystinuria, matching-pair for age category to the patients of ADV7103 Cohort, will receive their own alkalinising treatment (SoC) taken at the usual dose and frequency and will follow their usual first intention treatment (hydration and diet) for a 2-year-period.
15838341|NCT04137952|Behavioral|size of error visual feedback|The strategies are expected to enhance opportunities of error experience and motor exploration via modified visual feedback, underlying facilitations of attentional resource and error-related neural networks.
15838342|NCT04137939|Device|smart exercise system|The smart exercise system contains an upper extremity ergometer (UEE) and a lower extremity ergometer (LEE). The revolutions per minute (RPM) of the ergometer are instructed to maintain in 55-65. The resistance of UEE is set from level 1 at the first session, and adjusted by rating of perceived exertion (RPE) of each user after each end of the session. The resistance of LEE is set from level 2 at the first session, and adjusted by rating of perceived exertion (RPE) of each user after each end of the session.
15838343|NCT04137926|Diagnostic Test|MicRNAs battery|for MCI due to AD diagnosis
15838344|NCT04137913|Behavioral|Musical arts intervention|A 6-week group music class that incorporates listening, theory, performance, and creation of music.
15838345|NCT04137900|Drug|TAB004|Recombinant humanized IgG4κ monoclonal antibody specific to BTLA for injection
15838346|NCT04137900|Drug|Toripalimab|a human IgG4k monoclonal antibody that specifically binds to the programmed death 1 (PD-1)
15838347|NCT04137887|Biological|Quadrivalent Influenza Vaccine (split virion, inactivated) High-Dose (QIV-HD)|Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: Intramuscular
15838348|NCT04137887|Biological|Standard-Dose Inactivated Influenza Vaccine Quadrivalent, Northern Hemisphere strains (QIV-SD)|Pharmaceutical form:Suspension for injection in pre-filled syringe Route of administration: Intramuscular
15838349|NCT04137874|Diagnostic Test|eSTROKE model|The eSTROKE model includes an electronic learning module, a full day course with practical teaching of National Institute of Health Stroke Scale and a mobile application which will be used for communication with in-hospital stroke physician
15838350|NCT04137874|Other|Control|Conventional prehospital care
15838351|NCT04137861|Other|Bioceramics|root repair material
15838352|NCT04137848|Procedure|Osteopathic Manipulative Treatment (OMT)+ Multidisciplinary Intensive Rehabilitation Treatment (MIRT)|OMT: 4-week manual therapeutic program with a weekly session of osteopathic examination and manipulation of somatic disfunctions in ambulatory setting. MIRT: 4-week physical therapy with 4 daily sessions (1 hour each), 5days/week, in a hospital setting. The first session comprises cardiovascular warm-up activities, relaxation, muscle stretching, exercises to improve the range of motion of different joints, exercises to improve the functionality of the abdominal muscles, and postural changes in the supine position. The second session includes exercises to improve balance and gait using stabilometric platform,treadmill plus, crossover and cycloergometer. The third and fourth pertain occupational and speech therapy.
15838353|NCT04137848|Procedure|Sham Osteopathic Manipulative Treatment (SOMT)+ Multidisciplinary Intensive Rehabilitation Treatment (MIRT)|"SOMT: 4-week of sham osteopathic therapeutic program with a weekly session of osteopathic examination and manipulation in ambulatory setting.
~MIRT: 4-week physical therapy with 4 daily sessions (1 hour each), 5days/week, in a hospital setting. The first session comprises cardiovascular warm-up activities, relaxation, muscle stretching, exercises to improve the range of motion of different joints, exercises to improve the functionality of the abdominal muscles, and postural changes in the supine position. The second session includes exercises to improve balance and gait using stabilometric platform,treadmill plus, crossover and cycloergometer. The third and fourth pertain occupational and speech therapy."
15838354|NCT04137835|Device|Showmotion|Each healthy volunteers will wear sensors at the interested joint and do the measurement.
15838355|NCT04137822|Biological|IMM-101|IMM-101 10mg/mL, a suspension of heat-killed whole cell M. obuense in borate-buffered saline. The treatment regimen with IMM-101 is one dose given every 2 weeks for three doses followed by 4 weeks rest, then one dose is given every 2 weeks for a further three doses. Subsequent doses are given every 4 weeks.
15838356|NCT04137809|Device|AMBLE|Treadmill walking while wearing AMBLE device; three times a week for two weeks; 45-60 minutes per session.
15838357|NCT04137783|Other|no intervention|there is no intervention in this study, only observation.
15838358|NCT04137770|Other|Ice pack and ketorolac|Scheduled IV ketorolac will be administered and ice packs will be applied to the surgical site
15838359|NCT04137757|Other|Lower Body Negative Pressure|Lower body negative pressure will be applied.
15838360|NCT04137757|Other|Sham Pressure|Noise will be turned on but no pressure will be applied.
15838361|NCT04137744|Procedure|AXILLARY REVERSE MAPPING|subcutaneous injection of 1to 2 ml methylene blue 15 minutes before the procedure, identification of blue LN and lymphatic vessels
15838362|NCT04137731|Device|Interferential Current Therapy|IFC treatment after Total Knee Arthroplasty
15838363|NCT04137718|Other|nonIntervention|nonIntervention
15838364|NCT04137705|Other|Multiparametric MRI|A standardised MRI protocol that provides a number of quantitative metrics on liver and other organs relevant to type 2 Diabetes - pancreas, kidneys, spleen and aorta
15838365|NCT04137692|Other|Red Blood Cell Transfusion|The procedure will be performed as an outpatient according to protocols established for sickle cell anemia patients. Two IVs are placed for the purposes of transfusion, one for draw and one for return. Patients will undergo isovolemic hemodilution-red cell exchange (IHD- RBCx) with up to 10 units of red cell antigens (Rh group, Kell, Duffy, Kidd blood group antigens) matched normal donor red cells to replace a target of 70% of the patient's red cells with donor red cells.Total time of procedure: approximately 150 minutes.
15838366|NCT04137679|Radiation|Definitive Radiochemotherapy|Radiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day
15838367|NCT04137679|Procedure|Neoadjuvant Radiochemotherapy followed by surgery|Concurrent Radiochemotherapy: Radiotherapy,IMRT, 40Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day; Receive radical surgery 4 to 6 weeks later.
15838368|NCT04137653|Drug|nab-Paclitaxel+carboplatin|Nab-P (Abraxis BioScience, LLC., Mclrose Park, IL, USA; drug license No. H20091059), 125 mg/m2, intravenous drip for 30 minutes once, on days 1 and 8, 21 days as a session for a total of 6 sessions; at the same time, carboplatin (Qilu Pharmaceutical Co., Ltd., Jinan, Shandong Province, China; drug license No. Guoji Zhunzi H20020181), AUC=2 mg•min/mL, intravenous drip for 120 minutes once, on days 1 and 8, 21 days as a session for a total of 6 sessions.
15838369|NCT04137653|Drug|Paclitaxel+carboplatin|Paclitaxel (Yangtze River Pharmaceutical Co., Ltd., Taizhou, Jiangsu Province, China; drug license No. Guoyao Zhunzi H20053001), 125 mg/m2, intravenous drip for 30 minutes once, on days 1 and 8, 21 days as a session for a total of 6 sessions; at the same time, carboplatin, AUC=2 mg•min/mL, intravenous infusion for 120 minutes once, on days 1 and 8, 21 days as a session for a total of 6 sessions.
15838370|NCT04137640|Drug|palbociclib combined with letrozole|Endocrine group will receive palbociclib combined with letrozole: palbociclib (Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany; license number: H20180040) 125 mg/d, every 28 days as a cycle (medication for 3 consecutive weeks and withdrawal for 1 week); letrozole (Novartis Pharma Schweiz AG, Stein, Switzerland; license number: H20140149) 2.5 mg/d, for 6 consecutive months.
15838424|NCT04137172|Procedure|aparoscopic IIPOM hernioplasty with intracorporeal repair using proline 0 versus stratifix PDS|"Group II:
~Using PDS 0, a stratifix suture (STRATAFIX™ Symmetric PDS™ Plus Knotless Tissue Control Device) versus proline 1 , used to repair and plicate the defect then mesh fixation"
15838558|NCT04136132|Other|Biological collection|The biological collection will also include samples of blood samples collected before or after surgery but also samples frozen and/or paraffin-embedded tissue sections.
15838676|NCT04135235|Drug|TDF|Dipirofurate fumarate tenofovir
15838371|NCT04137640|Drug|epirubicin combined with cyclophosphamide and sequential docetaxel|Chemotherapy group will receive epirubicin combined with cyclophosphamide and sequential docetaxel: epirubicin (Pfizer Wuxi Pharmaceutical Plant, Wuxi, China; license number: GYZZ H20000496), 90 mg/m2, intravenously, for 120 minutes, once every four weeks, totally four times; cyclophosphamide (Baxter Oncology GmbH, Halle, Germany; license number: H20160468), 600 mg/m2, once every four weeks, totally four times; sequential docetaxel (Sanofi-aventis Deutschland GmbH, Frankfurt am Main, Germany; license number: GYZZ J20150083) 75 mg/m2, intravenously, for 120 minutes, once every four weeks, totally four times.
15838372|NCT04137627|Drug|Melatonin 20 MG Oral Capsule|The administration of Melatonin 20 mg in addition to neoadjuvant chemotherapy to observe the antioxidant and onco-static effect.
15838373|NCT04137627|Drug|Placebo oral capsule|The administration of placebo capsule in addition to neoadjuvant chemotherapy
15838374|NCT04137614|Procedure|Drug coated balloon (DCB)|Drug coated balloon (DCB）is a new type of PTA, which could improve the re-stenosis rate significantly.
15838375|NCT04137614|Procedure|Digital substraction angiography (DSA)|DSA was used to evaluated the stenosis of renal artery
15838376|NCT04137588|Drug|Antiangiogenesis Agents|antiangiogenesis agents plus chemotherapy as first line treatment
15838377|NCT04137588|Drug|Immune checkpoint inhibitor|immune checkpoint inhibitor plus chemotherapy as first line treatment
15838378|NCT04137575|Behavioral|ConquerFear-Group|The intervention consist of one 1½-hour individual session in which a psychologist will conduct an oral psychological assessment, and five 2-hour group sessions. The key goals of the intervention are to: a) teach strategies for controlling worry and excessive threat monitoring; b) modify underlying unhelpful beliefs about worry; c) develop appropriate monitoring and screening behaviors; d) educate about follow-up care and empirically-supported behavioral change (e.g., weight loss, exercise, etc.) to improve overall survival; e) address existential changes brought about by a cancer diagnosis; f) promote goal-setting. Each session is accompanied by home-based practice of skills learned in session and home reading to consolidate skill acquisition. Four trained psychologists (MSc) will perform the therapy. The intervention will be delivered on Zoom, a secure online platform.
15838379|NCT04137575|Behavioral|Relaxation Training|The control group will receive one 1½-hour individual session and participate in five 2-hour group sessions. Patients will receive guided progressive muscle relaxation training. The intervention will be delivered on Zoom, a secure online platform.
15838380|NCT04137562|Biological|ADSTEM Inj.|Two 5mL of the following study drug is pre-mixed with 320mL of 0.9% normal saline is injected intravenously twice for the duration of the study. Treatment group: ADSTEM Inj. 0.5x10^8 cells/5mL
15838381|NCT04137562|Other|Placebo|330mL of 0.9% normal saline is injected intravenously twice for the duration of the study.
15838382|NCT04137536|Drug|anti-EGFR-bispecific antibody armed activated T-cells|"Phase I:
~First 3 participants, twice weekly infusions of 10^10 EGFR BATs infusions
~If there is toxicity in 0 or 1 of 3 participants, 3 additional participants will be added to the dose level of up to 10^10.
~If >/= 2 of 6 participants experience DLTs, then the dose will be reduced to 7.5 x 10^9 per infusion
~If only 0 or 1 participants has toxicity in the first 6, then the study will proceed to enroll in the expansion cohort
~Expansion cohort:
~- 8 infusions of 7.5 x 10^9 or 10^10 EGFR BATs in 22 evaluable participants (including the 6 participants treated at the maximum tolerated dose in Phase I)"
15838383|NCT04137510|Device|Percutaneous coronary intervention|It's a non-surgical procedure that uses a catheter to place a stent into a coronary blood vessel in order to open up the vessel.
15838384|NCT04137497|Diagnostic Test|The Coma Recovery Scale-Revised and the Nociception Coma Scale-Revised (NCS-R)|All enrolled DOC patients were evaluated at least five times over one week by two trained professionals using the Chinese version of the CRS-R. During the evaluation of the patient's consciousness level, the NCS-R was used to evaluate the pain response of all patients in random order at least once, and the best behavioral response (i.e., the highest score) of each subscale was recorded during resting, noxious, and physiotherapy conditions, respectively, according to the NCS-R guidelines.
15838386|NCT04137445|Other|Baby Foods|Commercially available baby foods
15838387|NCT04137445|Other|Foods from the home|Caregiver will provide participant with usual foods from the home
15838388|NCT04137432|Drug|Oxytocin nasal spray|Intranasal administration of 24 international units oxytocin.
15838389|NCT04137432|Drug|Placebo|The placebo nasal sprays contains identical ingredients except for the peptide itself.
15838390|NCT04137419|Dietary Supplement|Probiotic lozenges|Probiotic strains
15838391|NCT04137419|Other|Placebo|Similar to ProlacSan lozenges in taste in colour
15838392|NCT04137393|Combination Product|brushing|mechanical and chemical plaque removal
15838393|NCT04137380|Drug|Mirikizumab - IV|Administered IV
15838394|NCT04137380|Drug|Mirikizumab - SC|Administered SC
15838395|NCT04137380|Drug|Placebo - IV|Administered IV
15838396|NCT04137380|Drug|Placebo - SC|Administered SC
15838397|NCT04137367|Behavioral|Affective bias modification|In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the active condition, the probe appears at the location of the most positive stimuli of each pair in 87 % of trials (encouraging a positive affective bias). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.
15838465|NCT04136925|Other|questionnaire|questionnaire before and after race
15838466|NCT04136912|Drug|Definity|Perflutren will be administered in split doses using the dosing range and administration type IV bolus) within the perflutren prescribing information. When administered as a bolus, the package insert recommends 10 uL/kg patient weight administered within 30-60 seconds, followed by a 10mL saline flush with a second dose of 10 uL/kg patient weight 30 minutes following the first dose, if needed.
15838559|NCT04136119|Other|questionnaire|survey exploring practice of vitamin and micronutrient supplementation
15838803|NCT04134130|Drug|Testosterone Undecanoate|One dose 1000 mg testosterone once, after 3 weeks.
15838398|NCT04137367|Behavioral|Sham Affective bias modification|In the Affective bias modification (ABM) procedure, paired stimuli (e.g. a negative and a positive facial expression) are presented on a laptop screen, followed by one or two probes (dots) appearing in the spatial location of one of the stimuli. Participants are then required to press one of two buttons as quickly as possible to indicate the number of dots in the probe. Stimuli presentation time is 50% 500 ms and 50 % 1000 ms (evenly distributed throughout the task). In total, the ABM will comprise 90 trials of paired images of faces of different valences. In the sham condition, the probe appears at the location of the most positive stimuli of each pair in 50 % of trials (no contingency between facial expressions shown and the probe location). Participants will do ABM in their homes (approx. 5 min.) twice a day for two weeks (28 sessions) using laptop computers provided by us.
15838399|NCT04137354|Other|Intermittent placebo iron supplement|Placebo iron supplements are also three tablets containing the same ingredients as for iron tablets and will be given to the children on a weekly basis for the whole duration of the intervention (i.e. the school year of 9 months)
15838400|NCT04137354|Other|Intermittent iron supplement|Three iron tablets containing 42 mg of elemental iron will be provided to the children on a weekly basis for the whole duration of the intervention (i.e. the school year of 9 months)
15838401|NCT04137354|Other|Placebo Vitamin A|Children will receive in a colorful Eppendorf tube 400 micro-liter of corn oil stabilized with vitamin A twice during the intervention period of 9 months, at baseline (after enrollment) and at mid-line (4.5 months).
15838402|NCT04137354|Other|High-dose Vitamin A supplement|Children will receive in a colorful Eppendorf tube 400 micro-liter of oil-based preparation of retinyl palmitate that contains the equivalent of 100,000 IU (110μmol) of vitamin A and stabilized with 20IU of vitamin E twice during the intervention period of 9 months, at baseline (after enrollment) and at mid-line (4.5 months).
15838403|NCT04137341|Drug|GLPG1972 - A|Film-coated tablet, formulation A
15838404|NCT04137341|Drug|GLPG1972 - B|Film-coated tablet, formulation B
15838405|NCT04137341|Drug|GLPG1972 - C|Film-coated tablet, formulation C
15838406|NCT04137328|Drug|Liraglutide|0.6mg/day in the first week, if there is no obvious discomfort, 1.2mg/day in the second week, subcutaneous injection, lasting for 3 months
15838407|NCT04137328|Drug|insulin|Add or adjust insulin (when basic insulin is preferred for those who do not use insulin, such as those who have already used insulin, adjust the dosage or program according to the condition, inject subcutaneously) for 3 months
15838408|NCT04137315|Device|Blood measurement|Single fingerprick to measure haemoglobin and haematocrit measurements using a potential haemoglobin home monitoring system.
15838409|NCT04137302|Drug|Hydrocortisone administration|Hydrocortisone administration with collection of blood, urine and saliva samples before (1 week), during (5 days) and after (1 week) the 2 treatments
15838410|NCT04137289|Drug|BI 905711|BI 905711
15838411|NCT04137276|Drug|vitamin C, vitamin B1|vitamin C 1,5 g/6 hours IV + thiamine 200 mg/12 hours for 3 days
15838412|NCT04137276|Drug|vitamin B1|thiamine 200 mg/12 hours for 3 days
15838413|NCT04137263|Other|DOSE formulation|over-the-counter topical
15838414|NCT04137250|Procedure|Hamstring|The intervention will consist of make an incision on the medial side of the proximal portion of the leg approximately 3 centimeters to dissect by planes until the tendons of the hamstrings are located, which will be removed surgically with specialized instruments and the wound will be closed, for later These tendons be used as an autograft for the reconstruction of the anterior cruciate ligament
15838415|NCT04137250|Procedure|Quadriceps tendon|orThe intervention consisted in making an incision in the anterior aspect of the distal portion of the thigh of approximately 3 centimeters to dissect by planes until locating the membranous portion of the quadriceps tendon, from which will be removed a portion of surgical way with specialized instruments and the Wound will be closed, for later this tendon to be used as an autograft for the reconstruction of the anterior cruciate ligament.
15838418|NCT04137211|Behavioral|Prolonged sitting with social break|Participants are required to sit for three hours (reading is permitted), with a toilet break in between. Every thirty minutes participants will have a short social break. Test day begins at 7:30 with pretest measures, followed by the intervention at about 9:00, which will end around 12:00, with subsequent posttest measures.
15838419|NCT04137211|Behavioral|Prolonged sitting with walk break|Participants are required to sit for three hours (reading is permitted), with a toilet break in between. Every thirty minutes participants will have a physical activity break, where they will perform a brisk walk for about three minutes on a treadmill at a predetermined speed and grade based on the fitness test performed during the familiarization session. Test day begins at 7:30 with pretest measures, followed by the intervention at about 9:00, which will end around 12:00, with subsequent posttest measures.
15838420|NCT04137211|Behavioral|Prolonged sitting with simple resistance activities|Participants are required to sit for three hours (reading is permitted), with a toilet break in between. Every thirty minutes participants will have a physical activity break, where they will perform simple resistance activities following a video for about three minutes. Test day begins at 7:30 with pretest measures, followed by the intervention at about 9:00, which will end around 12:00, with subsequent posttest measures.
15838421|NCT04137198|Drug|Sufentanil|intranasal administration of Sufentanil Forte 0,5mcg/kg as first dose and 0,3mcg/kg as titration doses
15838422|NCT04137185|Drug|Recombinant Human Thyroid Stimulating Hormone for Injection|rhTSH was dissolved in 1.2 mL of sterile water for injection to obtain a solution containing 0.9 mg/mL rhTSH.
15838423|NCT04137172|Procedure|laparoscopic (IPOM) hernioplasty without repair|"Under general anesthesia, supine position, lateral visiport 12mm was inserted at the left anterior axillary line . Other two 5mm ports were inserted under vision. A 30-degree optics were used. Adhesiolysis was done . The contents of hernia were reduced . The borders of the defect were illuminated and outlined. The abdominal wall was marked from outside for measurement of defect size and for corners fixation of mesh with 5cm away from defect edge. Defect with axis from 9 to 12 cm is considered big defect.
~Group I:
~Proline (1) sutures were applied at the corners of the mesh introduced into the peritoneal cavity. Endoclose passed at the marked site from abdominal wall, sutures hanged and tied subcutaneously, completion of mesh fixation using secure strap ."
15838553|NCT04136184|Drug|Inotersen|Inotersen by subcutaneous injection
15838425|NCT04137172|Procedure|laparoscopic IPOM hernioplasty with transfacial closure using PDS LOOP 0|The PDS loop sutures were prepared by cutting the needles, keeping two detached ends and one blind end. A small curved supraumbilical incision was done. The endoclose passed through upper border of incision penetrating the abdominal wall above the defect, hanging the blind end of the PDS Loop to outside. It passed through the lower border of the wound crossing the defect. It hanged one detached end of the PDS Loop suture to outside, passed again through lower border of incision to catch the other detached end. The two ends were hanged not tied to avoid incision closure. The process is repeated by passing 1-2 cm lateral or medial to the previous sutures, then blind ends were divided. Lastly, all sutures are tied. Mesh was fixed as before.
15838426|NCT04137159|Other|Functional Electrical Stimulation rowing exercise|Full-body aerobic exercise
15838427|NCT04137146|Device|Sacral Nerve Stimulation|"Implantation of a sacral nerve neurostimulation system: A single electrode (Interstim® model 3889-28; Medtronic, Minneapolis, MN) was inserted bilaterally into the sacral foramen (S3), connected to an internal pulse generator (Medtronic Interstim
~® II 3058)"
15838428|NCT04137133|Diagnostic Test|collection|bronchial secretions, blood, stools, superficial skin sample, dental plaque sample and urine
15838429|NCT04137120|Drug|Aflibercept (BAY86-5321, Eylea)|Intravitreal injection of aflibercept as scheduled by treating physician
15838430|NCT04137107|Drug|Oxaliplatin|Given standard of care oxaliplatin
15838431|NCT04137107|Drug|Duloxetine Hydrochloride|Given PO
15838432|NCT04137107|Drug|Duloxetine|Given PO
15838433|NCT04137107|Other|Quality-of-Life Assessment|Ancillary studies
15838434|NCT04137107|Other|Questionnaire Administration|Ancillary studies
15838435|NCT04137107|Other|Placebo|Given PO
15838436|NCT04137094|Behavioral|Persuasive Health Communication Intervention|A persuasive health communication intervention will be performed
15838437|NCT04137081|Behavioral|App-based mindfulness training|Unwinding Anxiety is an app-based mindfulness training program which includes a progression through 30+ daily modules. Each module's training is delivered via short video tutorials and animations (~10 min/day). Each training builds on the previous one; modules are 'locked' so that they can only be viewed at a pace of 1/day (previous modules can be reviewed at any time). A built-in self-assessment is taken after every seven modules to ensure key concepts are learned before moving on with automated suggestions on which modules to repeat based on self-assessment results. User-initiated guided practices range from short exercises (30 seconds) to manage anxiety the moment it arises to formal guided meditations (up to 15 minutes), and can be accessed at any time.
15838438|NCT04137068|Behavioral|Reduced Activity or Maintain habitual activity|Participants reduce their activity level to <5,000 steps/day and <50 % of baseline steps.
15838439|NCT04137055|Drug|ZSP0678-10mg|ZSP0678 tablet administered orally under fasted condition
15838440|NCT04137055|Drug|ZSP0678-30mg|ZSP0678 tablets administered orally under fasted condition
15838441|NCT04137055|Drug|ZSP0678-60mg|ZSP0678 tablets administered orally under fasted condition
15838442|NCT04137055|Drug|ZSP0678-120mg|ZSP0678 tablets administered orally under fasted condition
15838443|NCT04137055|Drug|ZSP0678-180mg|ZSP0678 tablets administered orally under fasted condition
15838444|NCT04137055|Drug|ZSP0678-240mg|ZSP0678 tablets administered orally under fasted condition
15838445|NCT04137055|Drug|ZSP0678-320mg|ZSP0678 tablets administered orally under fasted condition
15838446|NCT04137055|Drug|ZSP0678|ZSP0678 tablets administered orally under fasted or fed condition
15838447|NCT04137055|Drug|ZSP0678-Dose 1|ZSP0678 tablets administered orally once daily for 14 Days
15838448|NCT04137055|Drug|ZSP0678-Dose 2|ZSP0678 tablets administered orally once daily for 14 Days
15838449|NCT04137055|Drug|ZSP0678-Dose 3|ZSP0678 tablets administered orally once daily for 14 Days
15838450|NCT04137055|Drug|ZSP0678 Placebo|Participants will receive placebo matching to ZSP0678 orally.
15838451|NCT04137042|Drug|Saline|Intraoperative fluid therapy is administrated by using 0.9% saline
15838452|NCT04137042|Drug|Balanced crystalloid|Intraoperative fluid therapy is administrated by using balanced crystalloid
15838453|NCT04137029|Drug|Formoterol|The participants will receive inhalation of formoterol 12 micrograms
15838454|NCT04137029|Drug|Tiotropium Bromide|The participants will receive inhalation of tiotropium bromide 18 mkg once
15838455|NCT04137029|Diagnostic Test|metacholine test|The participants will receive inhalation of metacholine once
15838456|NCT04137016|Other|Mobile application|
15838457|NCT04137003|Other|Rouge et Or Program|It is a detailed, structured and precise training program. It is used from the third-month post ACL surgery to the sixth month.
15838458|NCT04137003|Other|CHU intervention guide|From the third month to the sixth month, it outlines the progression to have in the training without precise information on exercises, parameter or frequency.
15838459|NCT04136990|Procedure|Isolated ACL reconstruction|Isolated ACL reconstruction using the bone-patellar tendon autograft.
15838460|NCT04136990|Procedure|ACL + LEAT reconstruction|ACL reconstruction using the bone-patella-tendon-bone autograft combined with LEAT using the mini Lemaire technique.
15838461|NCT04136977|Device|Eustachian tube dilation|Unilateral or bilateral balloon dilation of the Eustachian tube using the FDA-cleared XprESS ENT Dilation System
15838462|NCT04136964|Other|Neck COMI|Patients will be asked to fill a questionnaire booklet consisting of five patient-reported outcome measures twice within 14 days.
15838463|NCT04136951|Other|PREVENT clinical decision support|PREVENT clinical decision support tool consideres five patient risk factors as significant predictors of patient's priority for the first homecare nursing visit: (a) Presence of wounds (either surgical or pressure ulcers); (b) a documented comorbid condition of depression; (c) need for assistive equipment, assistive person, or both for toileting; (d) number of medications; and (e) number of comorbid conditions. Each risk factor was assigned a specific score based on the logistic regression weights. For instance, for a wound (e.g., pressure ulcer, vascular ulcer), the patient received a score of 15 points. For each additional co-morbid condition, one point was added to the final score. Summing the scores for the factors generated a cumulative score. The optimal cut-off point was established based on the regression model performance statistics, indicating that patients with a score greater than 26 points are a high priority for the first nursing visit.
15838464|NCT04136938|Other|Social marketing campaign|A social marketing campaign of prevention workshop sessions will be performed.
15838467|NCT04136912|Device|Acoustic Angiography|"Acoustic angiography imaging involves a research ultrasound scanner as well as conventional b-mode ultrasound to guide the location of the imaging. The conventional ultrasound will be conducted just prior to the acoustic angiography for localization. Imaging will be performed within the package insert guidelines for ultrasound system mechanical index (a measurement of output power) when imaging perflutren contrast agent (less than 0.8).
~Acoustic angiography imaging will be performed by trained medical personnel using mild compression to eliminate motion. Total imaging time is estimated to be less than 15 minutes."
15838468|NCT04136899|Other|Dukes scale|collection of questionnaires
15838469|NCT04136886|Drug|Cisplatin|cisplatin is to give from the first Day of radiation therapy D1,D22 Q3W for 2 cycles Radiation: IMRT IMRT is to give 60Gy in 27 fraction
15838470|NCT04136886|Radiation|IMRT|Radiation: IMRT IMRT is to give 60Gy in 27 fraction
15838471|NCT04136873|Drug|CVL-231|CVL-231
15838472|NCT04136873|Drug|Matching Placebo|Placebo matching CVL-231
15838473|NCT04136847|Device|SkinPen Precision|Surgical instrument motors and accessories/attachments/Hydrogel
15838474|NCT04136834|Biological|PT01 (Pegtomarginase)|PT01 (Pegtomarginase) breaks down arginine in the blood stream, reducing the supply of arginine and stopping the cancer cells from growing. Normal cells can continue to make their own arginine inside the cell, so PT01 targets the rapidly growing cancer cells.
15838475|NCT04136821|Dietary Supplement|Oceanix|Ingredient contains highly active antioxidant enzymes, including superoxide dismutase (SOD), as well as essential fatty acids, vitamins, amino acids and minerals.
15838476|NCT04136821|Other|Resistance Training|6 weeks of supervised and programmed whole body resistance training, performed 3-5 times per week.
15838477|NCT04136808|Drug|enfortumab vedotin (EV)|Participants will receive an intravenously (IV) administered dose once weekly for the first 3 weeks of every 4-week cycle (i.e., on days 1, 8, and 15)
15838478|NCT04136782|Drug|Albumin-bound paclitaxel combined with carboplatin|Albumin-bound paclitaxel combined with carboplatin: Albumin-bound paclitaxel (Abraxis BioScience, LLC., Mclrose Park, IL, USA; certificate number: H20091059) will be intravenously administered at 125 mg/m2 for 30 minutes on days 1 and 8 of each 21-day session of treatment. There will be six 21-day sessions of treatment. At the same time, carboplatin (Qilu Pharmaceutical Co., Ltd., Jinan, Shandong Province, China; National Drug Approval Number: H20020181) will be intravenously administered at AUC = 2 mg•min/mL for 120 minutes on days 1 and 8 of each 21-day session of treatment. Carboplatin must be hydrated for 3 days before use to prevent nephrotoxicity.
15838479|NCT04136782|Drug|Epirubicin combined with docetaxel|Epirubicin (Pfizer Pharmaceutical (Wuxi) Co., Ltd., China; National Drug Approval Number: H20000496) will be intravenously administered at 90 mg/m2 for 120 minutes on day 1 of each 21-day session of treatment. At the same time, docetaxel (Sanofi-aventis Deutschland GmbH, Frankfurt am Main, Germany; National Drug Approval Number: J20150083) will be intravenously administered at 75 mg/m2 for 120 minutes. Drug administration will be performed once every other 3 weeks for four times.
15838480|NCT04136769|Procedure|Visceral Debranching|Visceral debranching is defined as a vascular reconstruction with the aim of ensuring a sufficient arterial blood flow to the mesentery and liver after the subsequently planned tumor resection, which usually comprises ligation of the gastroduodenal artery or other relevant collateral vessels. All open vascular procedures can be employed for visceral debranching. Examples are aorto-visceral or iliaco-visceral bypasses using autologous vein or an allogeneic graft, or re-insertion of the superior mesenteric artery or celiac trunk into the aorta.
15838484|NCT04136743|Device|Lipogems|The Lipogems system (Lipogems International SpA, Milan, Italy) is designed to isolate autologous, micro-fragmented adipose tissue without enzymes or other additives. It uses mild mechanical forces to break down adipose tissue that is extracted from the patient into a form that can be injected into the tendon lesion and other degenerated tissues in a sterile and safe manner. The resulting product is rich in pericytes and mesenchymal stromal cells, retained within an intact stromal vascular niche, that is ready for use in clinical applications.
15838485|NCT04136743|Drug|Dexamethasone|Triamcinolone Acetonide is a corticosteroid, which is a class of drugs that are commonly prescribed for shoulder pain. They work to reduce pain by limiting inflammation. They are typically injected into the subacromial space with or without ultrasound guidance.
15838486|NCT04136730|Behavioral|Home-based|Resistance exercise carried out unsupervised at home
15838487|NCT04136717|Other|Washout period|During this period the patients will breath spontaneously oxygen titrated using the FreeO2 device with a SpO2 target set at 90%. The period duration is 30 minutes.
15838488|NCT04136717|Device|NIV - FreeO2|"During this period the patients will receive NIV using FreeO2 device for oxygen titration with a SpO2 target set at 90%. Initially, the inspiratory pressure will be set to obtain a tidal volume between 6 to 8 mL/Kg of predictive body weight and positive end-expiratory end pressure (PEEP) at 5 centimeters of water (cmH2O).
~After NIV initiation, the parameters can be adjusted to improve patient comfort. The period duration is 30 minutes."
15838489|NCT04136717|Device|Nasal High flow Oxygen therapy - FreeO2|During this period the patients will receive NHFOT using the FreeO2 device for oxygen titration with a SpO2 target set at 90%. The high flow device will be set at 30 lpm.The period duration is 30 minutes.
15838490|NCT04136717|Other|CPAP - Oxygen constant flow|During this period, the patients will have their own CPAP with oxygen adjusted by hospital staff according to hospital protocol. The period duration is 15 minutes.
15838491|NCT04136717|Other|CPAP - FreeO2|During this period, the patients will have their own CPAP with oxygen adjusted using the FreeO2 device. SpO2 target will be set at 90% The period duration is 60 minutes.
15838492|NCT04136704|Procedure|Sleeve gastrectomy|Laparoscopic sleeve gastrectomy
15838493|NCT04136691|Other|simulation training|Burn patient scenario was performed with the intervention group.
15838494|NCT04136678|Other|walking training|15 minutes of conventional walking training 15 minutes of treadmill backward walking training 15 minutes of treadmil forward walking training
15838495|NCT04136665|Other|Physical Activity Adapted program|6-month APA home program, supervised by videoconferencing in post-cancer for children / AYA treated for leukemia
15838496|NCT04136652|Procedure|CO2 laser- treatment (DEKA SmartXide2 Laser System, MonaLisa Touch|women will receive a series of three treatments using a fractional (pulsed) CO2 laser system (SmartXide2 MonaLisa Touch, DEKA M.E.L.A Srl, Florence, Italy), each performed in an outpatient setting without analgesia. A tubular laser-probe is inserted in the vaginal canal until reaching the vaginal vault. A burst of laser pulses is transmitted through the probe and deflected at 90degrees in four directions towards the vaginal wall, then rotated 45degree for a second burst of pulses. Guided by markings on the probe, it is withdrawn 4mm and the procedure is repeated until reaching the introitus. Treatment parameters include power 30W, dwell time 1000us, 1000um spacing, using normal scan mode, with Smartstack setting for 1 at first application and 3 for the next two applications.
15838497|NCT04136639|Other|Miswak|sticks
15838498|NCT04136639|Other|Grape Seed Extract Mouthwash|Mouthwash
15838499|NCT04136639|Other|fluoride|mouthwash
15838500|NCT04136626|Device|Perspectives OCD|The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work) and behavioral skills (e.g., exposure and response prevention).
15838501|NCT04136626|Device|The Health and Well-Being Program|The website includes 12 modules related to general health and well-being (e.g., sleep and nutrition). Each module contains educational information and questions about an indvidual's experience with the given topic.
15838502|NCT04136613|Device|Copper Intra uterine contarceptive device ( Cu-T 380A)|Insertion of the Cu-T 380A during cesarean delivery immediately after placental removal.
15838503|NCT04136600|Drug|EGFR antibody and Chemotherapy|"Drug: Cetuximab Cetuximab: 500 mg/m2 iv on Day 1 of cycle every 3 weeks, until disease progression.
~Other Names:
~Erbitux Drug: Nimotuzumab Nimotuzumab: 400mg iv on Day 1 of cycle, every week, until disease progression
~Drug: Fluoropyrimidine 5-fluorouracil (5-FU): 2,400 mg/m2/day iv in first 46 hours of cycle, every two weeks for 12 cycles
~Other Names:
~5-Fu Drug: Capecitabine Capecitabine: 1000 mg/m2 po twice daily for 14 days every 3 weeks, for 6 cycles
~Other Names:
~Xeloda Drug: S-1 S-1: 60mg for BSA>1.5, 50 mg for 1.5>BSA>1.25 , 40mg for BSA<1.25 po twice daily for 14 days every 3 weeks, for 6 cycles
~Other Names:
~S-1 Drug: Oxaliplatin Oxaliplatin: 85 mg/m2 iv on Day 1 of cycle, every 2 week for 12 cycles with 5-Fu; Oxaplatin: 130 mg/m2 iv on Day 1 of cycle, every 3 week for 6 cycles combined with S-1 or Capecitabine;"
15838504|NCT04136600|Drug|Chemotherapy|"Drug: Fluoropyrimidine 5-fluorouracil (5-FU): 2,400 mg/m2/day iv in first 46 hours of cycle, every two weeks for 12 cycles
~Other Names:
~5-Fu Drug: Capecitabine Capecitabine: 1000 mg/m2 po twice daily for 14 days every 3 weeks, for 6 cycles
~Other Names:
~Xeloda Drug: S-1 S-1: 60mg for BSA>1.5, 50 mg for 1.5>BSA>1.25 , 40mg for BSA<1.25 po twice daily for 14 days every 3 weeks, for 6 cycles
~Other Names:
~S-1 Drug: Oxaliplatin Oxaliplatin: 85 mg/m2 iv on Day 1 of cycle, every 2 week for 12 cycles with 5-Fu; Oxaplatin: 130 mg/m2 iv on Day 1 of cycle, every 3 week for 6 cycles combined with S-1 or Capecitabine;"
15838505|NCT04136587|Other|Colonic fluid collection during endoscopy for analysis of the bacterial secretome|Colonic content will be collected by suction during routine colonoscopy including the residual fluid in the colon and stool contents and also suction of washing fluid (sterile physiologic H2O solution)
15838506|NCT04136561|Device|Midline catheter|Midline catheter placed in patients with existing standard of care CVC
15838507|NCT04136548|Drug|Fentanyl|Subjects will receive 75 ug Fentanyl while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.
15838508|NCT04136548|Other|Placebo|Subjects will receive saline while the effects of this drug on tolerance to a hemorrhagic insult will be assessed.
15838509|NCT04136535|Drug|Pemetrexed|Pemetrexed，500mg/m²，ivgtt ，d1，q3w
15838510|NCT04136535|Drug|Carboplatin|Carboplatin，AUC 5.0，ivgtt，d1，q3w，
15838511|NCT04136535|Drug|Anlotinib|Anlotinib ，12 mg，po，qd，d1-14，q3w；
15838512|NCT04136522|Procedure|conventional pancreaticoduodenectomy|In this subgroup, the surgeon will perform pancreaticoduodenectomy without isolation of superior mesenteric artery and dissection of nerve plexus and lymph node around superior mesenteric artery.
15838513|NCT04136522|Procedure|total mesopancreas excision including superior mesenteric artery first approach|In this subgroup, the surgeon will identify and isolate superior mesenteric artery before pancreatic transection, they dissect soft tissues including nerve plexus and node around superior mesenteric artery.
15838514|NCT04136509|Procedure|sinus floor elevation|sinus floor elevation with the lateral technique
15838515|NCT04136509|Procedure|bone core biopsy|After 6 month healing time reentry took place and bone core biopsy samples were collected from the augmented bone of the maxillary sinuses with a trephine drill. Biopsy samples were collected from the sites where the dental implants were to be placed.
15838516|NCT04136509|Device|dental implant placement|During reentry after bone biopsy dental implants were placed.
15838517|NCT04136509|Diagnostic Test|Cone Beam Computed Tomography scans (CBCT)|Preoperative CBCT scans are carried out before dental implant placement, 6 months after sinus floor elevations. Postoperative CBCT scans are taken 3 years after sinus floor augmentations.
15838518|NCT04136496|Device|Black-Eye Ink|There are two proposed studies utilizing the Ink during differing timepoints.Both will identify patients with breast cancer, with a biopsied metastatic axillary lymph node(LN) with a tissue marker clip placed, as is current practice. In Study A, 0.5mL of Black Eye Ink will be placed in the metastatic LN after neoadjuvant therapy. In Study B, 0.5mL of Black Eye Ink will be placed before neoadjuvant therapy. In both studies, the LN containing the tissue marker clip will be the one to have the radioactive seed and Ink inserted. The seed will still be inserted, in the event the dye is not well-visualized. In both studies, the surgeon will attempt to find the LN by direct visualization and then confirm the appropriate LN has been removed by using the Gamma probe and intra-operative radiographs. If the seed is not within the tattooed node, the LN containing the seed will also be removed. All lymph nodes injected with Ink will be removed by the surgeon;no Ink-injected node remains in body.
15838554|NCT04136171|Drug|AKCEA-TTR-LRx|ACKEA-TTR-LRx by subcutaneous injection
15838555|NCT04136171|Drug|Placebo|Matching placebo by subcutaneous injection
15838556|NCT04136145|Drug|Belimumab for IV|Belimumab will be available as white to off-white lyophilized cake at a unit dose strength of 400 mg to be reconstituted and diluted in normal saline to obtain 200 mg per dose.
15838557|NCT04136145|Drug|Belimumab for SC|Belimumab will be available as clear to opalescent, colorless to pale yellow sterile solution at unit dose strength of 200 mg/milliliter (mg/mL) for SC injection in a single-use, prefilled syringe contained within an auto-injector device.
15838519|NCT04136483|Behavioral|CBT-I|The theoretical framework is cognitive-behavioral therapy that includes sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive interventions and relaxation. The intervention has been adapted to adolescents by reducing the amount of psychoeducational information and the interventions related to changing cognitions. It involves six weekly face-to-face individual sessions with a therapist, supported by a participant workbook that contains information, work- sheets, and at-home tasks. Clinical psychologists or graduate clinical psychologists in training delivered the intervention sessions under supervision by the first author. Parents/care-givers were given information about the components, but did not take active part of the intervention.
15838520|NCT04136470|Biological|Collection of stool, blood (PBMC) and biopsy (FFPE)|Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).
15838521|NCT04136457|Other|Endurance training|Subjects perform a period of endurance training
15838522|NCT04136457|Other|Resistance training|Subjects perform a period of resistance training
15838523|NCT04136457|Other|Sprint training|Subjects perform a period of sprint training
15838524|NCT04136444|Drug|Padsevonil|Padsevonil will be administered in predefined dosages.
15838525|NCT04136431|Other|Programed cryotherapy and continuous passive motion|The intervention group started to use a CPM machine and applied programed cryotherapy intermittently within one hour while returning to the ward on the day of surgery.
15838526|NCT04136431|Other|Unrogramed cryotherapy and continuous passive motion|A CPM machine and cryotherapy were not applied on the day of surgery while returning to the ward
15838527|NCT04136418|Device|COPDPredict mobile App|An App on a mobile device is used by the patient to track the status of their COPD and inform the patient's care team
15838528|NCT04136418|Other|Usual care|Patients self-manage their COPD using prescribed medication in accordance with basic guidance information
15838529|NCT04136392|Device|ABIOMED, Inc. hemodynamic support devices|ABIOMED, Inc. hemodynamic support technology are the smallest and least invasive percutaneous ventricular support blood pumps available on the market. They are routinely used in clinical practice in a variety of clinical scenarios to support patients in prophylactic or emergent settings.
15838530|NCT04136379|Diagnostic Test|INR monitoring using a CoaguChek POC device|INR monitoring using a CoaguChek POC device
15838531|NCT04136366|Drug|ADX-2191 (intravitreal methotrexate 0.8%)|ADX-2191 (intravitreal methotrexate 0.8%) injected 13 times over 16 weeks upon completion of pars plana vitrectomy
15838532|NCT04136366|Other|Standard surgical care procedure|Standard surgical care performed upon completion of pars plana vitrectomy
15838537|NCT04136340|Other|In-person in clinic follow-up visit|Patient will be seen in-person (i.e. an IR/NV or AFX visit) in the clinic by a Supportive Care Specialist for at least 3 follow-up visits over 14 weeks. Any patients randomized to the in-person group who experience an extraordinary burden and/or are physically unable to attend their in-person visits will be able to be seen by their Supportive Care Service clinician via a home telemedicine visit (patients will return to their original group assignment if possible).
15838538|NCT04136340|Other|Telemedicine follow-up visit|"i. Patients will be seen by video telemedicine at home by a Supportive Care Specialist for at least 3 follow-up visits over 14 weeks.
~ii. Patients will have access to a clickable link that will initiate a video telemedicine call to the clinician's office. The clinical team will be responsible for answering such calls and for ensuring the clinician and the patient connect and begin the actual visit."
15838539|NCT04136327|Drug|GLPG1972 film-coated tablets|single oral dose of GLPG1972
15838540|NCT04136327|Drug|[14C]-GLPG1972 solution for infusion|a 15-minute IV infusion [14C]-GLPG1972
15838541|NCT04136327|Drug|[14C]-GLPG1972 oral solution|single oral dose of [14C]-GLPG1972
15838542|NCT04136314|Behavioral|Decision-Framed Survey|Survey will ask all subjects for will be asked to indicate basic demographic information, such as age, sex, race, and education level. Also, subjects will indicate whether they have been diagnosed with psoriatic arthritis. Importantly, patients will complete the survey questions anonymously, and no direct patient identifiers or HIPPA-protected information will be collected. Subjects will then be asked to indicate their preference for a hypothetical injectable medication after exposure to [A] a gain-framed message or [B] a loss-framed message.
15838543|NCT04136301|Other|Informative Video group|Informative Video group before labor in nulliparous women
15838544|NCT04136288|Device|MoreNova|Shockwave therapy delivered to the genital area with low dose shocks
15838545|NCT04136275|Biological|CAR-37 T cells|CAR-37 is an investigational treatment that uses the participant own immune cells, called T cells, to try to kill the cancerous cells
15838546|NCT04136262|Drug|Tripterygium wilfordii Hook F (TwHF)|Oral Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks.
15838547|NCT04136262|Drug|Methotrexate|Oral methotrexate 10 mg per week for 24 weeks.
15838548|NCT04136262|Other|Dummy Tripterygium wilfordii Hook F (TwHF)|Oral dummy Tripterygium wilfordii Hook F 20mg thrice daily for 24 weeks.
15838549|NCT04136249|Dietary Supplement|Over physical activity|105/5000 resistance training combined with nutritional monitoring on maximum strength of knee extensors
15838550|NCT04136236|Diagnostic Test|The diagnosis of Artificial Intelligence and endoscopist|When suspected esophageal mucosal lesion is observed using pCLE, endoscopist and AI will make a diagnosis independently. In addition, the endoscopist can not see the diagnosis of AI.
15838551|NCT04136197|Diagnostic Test|Manual palpation for incidence determination|The patients are positioned in a sitting and prone lying posture. Trigger points are discrete, local, hypersensitive spots located in a taut band of muscles. Palpation of the trigger point will cause elicitation pain over the affected area and radiation of pain toward a zone of reference and a local twitch response.
15838552|NCT04136184|Drug|AKCEA-TTR-LRx|AKCEA-TTR-LRx by subcutaneous injection
15838560|NCT04136106|Drug|IL-2|IL-2 is a medicine which can use in autoimmune disease, infection or cancer with different dose. Low-dose IL-2 preferentially used in autoimmune disease, such as SLE. Our enrolled SLE patients will divided into two groups depend on whether use IL-2 or not, combined with corticosteroid and immunosuppressor.
15838561|NCT04136093|Other|the MED|The MED diet will be composed of the basis food items traditional for the Mediterranean region i.e. olive oil, nuts, vegetables, fruits, and fish and this diet will be given an ad libitum approach. The MED diet will be giving a higher proportion of fat, at least 40% of the total energy, with 20% of the total energy from MUFAs, and less proportion of carbohydrates. To ensure the assumed supply of MUFAs and polyunsaturated fatty acids (PUFAs), the participants will be asked to daily intake 60 g (6 spoons) of extra virgin olive oil and 30 g (6 pieces) walnuts.
15838562|NCT04136093|Other|the DASH|The DASH diet will be giving a higher proportion of carbohydrates, at least 60% of total energy and less fat. The DASH diet will be composed wholegrain cereal products, fruit, vegetables, low-fat dairy products, fish, seafood, poultry, beans, seeds and nuts and will be recommending eating of the traditional polish food items for example oatmeal, rye bread, barley groats, apples, plums, etc. and reducing the supply of salt, sweets, sugars, fats especially saturated fats and red meat. In our study, the DASH diet will be given an ad libitum approach. The sufficient supply of carbohydrates and β glucans in the DASH diet will be ensured by daily consumption at least 50g oatmeal and 50g of barley groats.
15838563|NCT04136093|Other|Control diet|"The control group will only receive oral dietary recommendations based on the Harvard model Healthy Eating Plate, that recommend to eat a half of plate of vegetables and fruit, a quarter of plate of whole grains products, and a quarter of plate of protein products for one meal."
15838564|NCT04136080|Other|vasopressors|control the mean arterial pressure with vasopressors
15838565|NCT04136067|Drug|NNC0268-0965|One daily dose of 1.5, 4.0 or 6.0 nmol/kg administered s.c. (subcutaneously, under the skin) for 6 days
15838566|NCT04136067|Drug|insulin glargine|One daily dose of 3.0 nmol/kg administered s.c. for 6 days
15838567|NCT04136054|Behavioral|Adjusted group CBT-i for Anxiety and Affective disorders|Adjusted group CBT-i for Anxiety and Affective disorders. CBT-i includes sleep scheduling/sleep compression, stimulus control, relaxation, cognitive interventions and sleep hygiene advice. Adjustments include the relationship between sleep and the psychiatric conditions at hand and and working with motivational enhancement techniques to increase adherence to treatment.
15838568|NCT04136054|Other|Care as usual wait-list control group|Usual care at the clinic. This entails managing pharmacological treatment for the psychiatric problems and/or sleep problems. The clinic also provides different group treatments, for instance mindfulness groups and CBT groups for symptoms of worry and depression, and individual therapy.
15838569|NCT04136041|Device|Smartphone Application|The experimental group will watch movies using the Smartphone application for at least 10 min a day for 5 weeks.
15838570|NCT04136028|Drug|Kineret|Kineret at a dose of 8 mg/kg per day subcutaneously daily, every day at the same time
15838571|NCT04136015|Drug|Dasatinib 100 MG|The CML-CP patients with early(3m to 6m) molecular response failure on imatinib,Conversion dasatinib group or Imatinib group
15838572|NCT04135989|Device|Percutaneous coronary intervention with implantation of amphilimus-eluting stents for coronary artery disease.|Implantation of polymer-free, amphilimus-eluting, drug-eluting stents
15838573|NCT04135989|Device|Percutaneous coronary intervention with implantation of everolimus-eluting stents for coronary artery disease.|Implantation of biodegradable-polymer, everolimus-eluting, drug-eluting stents
15838574|NCT04135989|Drug|Personalized DAPT duration|Duration of dual antiplatelet therapy according to DAPT score for 3- or 6- months in patients with low DAPT score (stable CAD or ACS, respectively) or for 24-months in patients with high DAPT score
15838575|NCT04135989|Drug|Standard DAPT duration|Duration of dual antiplatelet therapy for 12 months.
15838576|NCT04135937|Drug|Bupropion|Smoking cessation pharmacotherapy prescribed in accordance with package insert.
15838577|NCT04135937|Drug|Varenicline|Smoking cessation pharmacotherapy prescribed in accordance with package insert.
15838578|NCT04135937|Behavioral|Cognitive Behavioral Therapy|Behavioral intervention; modules include identifying reasons for quitting, setting a quit date, breathing relaxation technique, identifying smoking triggers, identifying social support, and education about relapse prevention
15838579|NCT04135937|Drug|Nicotine Replacement Therapy|Participants may be prescribed single-formulation NRT (i.e., nicotine patch) or dual NRT (patch + rescue method such as nicotine gum, inhaler, or lozenges).
15838580|NCT04135937|Behavioral|Relapse Prevention Text Messaging|Participants will be invited to utilize SmokefreeVET, a mobile text messaging service for military Veterans trying to quit smoking. The 6- to 8-week program provides 24/7 encouragement, advice, and tips to help smokers quit smoking and stay quit.
15838581|NCT04135924|Other|Rehabilitation|physical exercise and respiratory muscle training
15838582|NCT04135898|Drug|SIBP-04|3mg/kg, infusion in 90 minutes
15838583|NCT04135898|Drug|Bevacizumab|3mg/kg, infusion in 90 minutes
15838584|NCT04135885|Drug|Folic Acid|The patient was continuously taking 7 ml of a brown sugar aqueous solution containing a certain amount of folic acid for 7 days before surgery (0.3 mg/d for children with 1-3 years old and 0.4 mg/d for children aged 4 to 5, once a day). After the operation, the PAED scores were performed every 10 minutes during the recovery of the child, at the time of extubation, and within 30 minutes after extubation. The PAED scores of all the children were performed by the same measurer. (The total score is 0~20 points, and the score ≥10 points is defined as the recovery period).
15838585|NCT04135885|Drug|Placebos|Patients in the placebo group received 20 ml of an aqueous solution of brown sugar with the same concentration as the intervention group on the 7th day before surgery. After the operation, the PAED scores were performed every 10 minutes during the recovery of the child, at the time of extubation, and within 30 minutes after extubation. The PAED scores of all the children were performed by the same measurer. (The total score is 0~20 points, and the score ≥10 points is defined as the recovery period).
15838586|NCT04135872|Other|strengthened nuitritional treatment|improving nutritional status by nasal feeding for dysphagia or iv. albumin when serum albumin level lower than 35g/L
15838627|NCT04135586|Other|Exercise training|Exercise program for 24 weeks (with neo-adjuvant treatment), with two sessions per week including both moderate-to-intense aerobic and resistance training. The intensity of each type of exercise will range between 65% and 100% of the maximum score in the Rated Perceived Exertion (RPE) scale.
15838587|NCT04135859|Behavioral|Physical Activity Lifestyle Intervention|Coaches work with participants on three elements of behaviors change: (1) changing attitudes towards physical activity; (2) increase perceptions of other people's approval of physical activity for the participants; (3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance accompanied by promoting appropriate goal-setting.
15838588|NCT04135859|Behavioral|Physical Activity Monitoring|A physical activity monitor (Fitbit) will be provided to both groups.
15838589|NCT04135846|Drug|Doxazosin|16 mg or maximum tolerated dose (MTD)
15838590|NCT04135846|Drug|Placebo|Matching placebo
15838591|NCT04135833|Drug|BPI-7711|BPI-7711 60 mg
15838592|NCT04135833|Drug|BPI-7711|BPI-7711 180 mg
15838593|NCT04135833|Drug|Itraconazole|Itraconazole 200 mg
15838594|NCT04135833|Drug|Rifampicin|Rifampicin 600 mg
15838595|NCT04135820|Drug|BPI-7711|BPI-7711 180 mg
15838596|NCT04135807|Combination Product|Microdevice|"Placement of 1-3 microdevices (depending on the size of the tumor) before tumor resection is started.
~The microdevices will dwell in the tumor tissue for a time window of 2-4 hours to allow time for tissue effects of the drugs (Temozolomide, Lomustine, Irinotecan, Carboplatin, Lapatinib, Osimertinib, Abenaciclib, and Everolimus) released by the microdevice reservoirs. The drugs used in this study will only include drugs already used systemically for the treatment of gliomas."
15838597|NCT04135781|Drug|nab paclitaxel|nab paclitaxel （120mg/m2；iv；d1，8）
15838598|NCT04135781|Drug|Tegafur|S-1 （<1.25 m2, 40 mg; 1.25 to ≤1.5 m2, 50 mg; and ≥ 1.5 m2, 60 mg；po；d1-14 bid）
15838599|NCT04135781|Drug|Oxaliplatin|Oxaliplatin（130mg/m2 , iv, d1）
15838600|NCT04135781|Drug|Capecitabine|Capetabine（1000 mg/m2 po, d1-14 bid ）
15838601|NCT04135768|Procedure|Wrist joint haematoma washout|After plating of the distal radius is performed, a small incision is made on the wrist joint capsule. This is the portal for fluid efflux. An intravenous cannula is used to puncture the wrist joint capsule adjacent to the first incision and normal saline is infused through this cannula into the wrist joint. The infusion continues until the fluid efflux from the first portal is clear and no longer blood stained. This will be the point at which the washout is considered to be complete.
15838602|NCT04135768|Procedure|Volar locking plate insertion of the distal radius|An anatomical locking plate is applied to the distal radius fracture using screws
15838603|NCT04135755|Other|no drug intervention|no drug or treatment intervention
15838604|NCT04135742|Device|Transcranial Alternating Current Stimulation|Transcranial alternate current stimulation (tACS) is a method of alternative current stimulation that can modulate neural activity by imposing local oscillatory activity.
15838605|NCT04135742|Behavioral|Cognitive Training|Cognitive training includes memory, reasoning, processing speed and role playing, etc.
15838606|NCT04135716|Diagnostic Test|Colonoscopy with assistance of Endo.Angel|Patients in exposed group will receive colonoscopy with assistance of Endo.Angel,a real-time quality monitoring system based on computer vision,which is used to monitor the velocity of insertion of the endoscope, record the time of insertion and withdrawal of the endoscope, and remind endoscopists of the blind areas caused by intestinal segment slipping.
15838607|NCT04135716|Diagnostic Test|Colonoscopy without assistance of Endo.Angel|Patients in non-exposed group will receive colonoscopy without assistance of Endo.Angel.
15838608|NCT04135703|Behavioral|Risk Prevention Services + Housing|opioid and related prevention services in addition to 6 months of rental assistance
15838609|NCT04135703|Behavioral|Risk Prevention Services Only|opioid and related prevention services for 6 months
15838610|NCT04135690|Procedure|Hepatic arterial infusion chemotherapy|administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks
15838611|NCT04135690|Drug|Toripalimab|240mg intravenously every 3 weeks
15838612|NCT04135690|Drug|Sorafenib|400mg bid po
15838613|NCT04135677|Drug|Rivaroxaban|Drug: Rivaroxaban 10mg Duration of treatment: 3 months(3months for DAPT afterwards)
15838614|NCT04135677|Drug|Rivaroxaban|Drug: Rivaroxaban 20mg Duration of treatment: 3 months(3months for DAPT afterwards
15838615|NCT04135677|Drug|DAPT|Drug: Aspirin 100mg and clopidogrel 75mg Duration of treatment:6 months
15838616|NCT04135664|Procedure|esophagectomy|esophagectomy with at least two-field (thoracic-abdominal) lymphadenectomy
15838617|NCT04135664|Combination Product|chemoradiation|concurrent chemotherapy and radiotherapy
15838618|NCT04135664|Other|active surveillance|No further adjuvant therapy
15838619|NCT04135651|Procedure|Paratracheal pressure|To apply paratracheal pressure, the thumb was placed over the left side of the trachea cephalad to the clavicle and medial to the sternocleidomastoid muscle.
15838620|NCT04135651|Procedure|Cricoid pressure|To apply cricoid pressure, the crocoid cartilage was compressed with a single-handed three-finger maneuvre towards the vertebral bodies.
15838621|NCT04135638|Procedure|Cover Group|"Cover when the ILM flap is everted over the MH gap in a single layer"
15838622|NCT04135638|Procedure|Fill Group|"Fill when the ILM is folded into multiple layers within the MH"
15838623|NCT04135625|Behavioral|Integrated nutrition and agricultural (INA) trainings|Monthly INA training session to help increase knowledge about nutrition and chicken husbandry and help to increase resiliency on a household level.
15838624|NCT04135625|Behavioral|Ceremonial Gifting of Livestock|Egg laying chickens will be presented as a gift to the child by a community champion (their religious leader or village chief)) during a gifting ceremony
15838625|NCT04135612|Other|Smartphone based communication|Each patient will document each evening her lactation performance during the day, and the App will generate a daily report transmitted by email every evening to our computerized research database. Every evening the patient will receive via email an individualized feedback from our team regarding her lactation. This feedback could include: reassurance and positive feedback and lactation tips in attempt to optimize specific obstacles.
15838626|NCT04135599|Device|transcranial direct current stimulation|Transcranial direct current stimulation (tDCS) is a non-invasive, safe and easy-to-operate neuro-electrophysiological technique, which becoming an emerging therapeutic option for many mental disorders.It can modulate cortical excitability of target brain region, neuron plasticity and brain connections. Previous studies suggest that tDCS could reduce cue-induced craving and improve cognition in drug addiction.
15838628|NCT04135586|Other|Control|Yoga + educational program
15838629|NCT04135560|Drug|PF-07038124 and Vehicle|PF-07038124 0.06% and vehicle Ointment BID applied to 1% Body Surface Area (BSA)
15838630|NCT04135560|Drug|PF-07038124 or vehicle|PF-07038124 0.01% or vehicle Ointment QD applied to 10% BSA
15838631|NCT04135560|Drug|PF-07038124 or vehicle|PF-07038124 0.01% or vehicle Ointment BID applied to 10% BSA
15838632|NCT04135560|Drug|PF-07038124 or vehicle|PF-07038124 0.03% or vehicle Ointment BID applied to 10% BSA
15838633|NCT04135560|Drug|PF-07038124 or vehicle|PF-07038124 0.06% or vehicle ointment BID applied to 10% BSA
15838634|NCT04135560|Drug|PF-07038124 or vehicle|PF-07038124 safe concentration or vehicle ointment BID applied to 20% BSA
15838635|NCT04135560|Drug|PF-07038124 or vehicle|PF-07038124 safe concentration or vehicle BID applied to 10% BSA
15838636|NCT04135547|Device|intra-osseous access vs. intra-venous access|EZ-IO®: The Arrow® Intraosseous Vascular Access System from Teleflex IV-catheter: form local qualified manufactures
15838637|NCT04135534|Drug|group A|mutonpain 0.05 mg/kg
15838638|NCT04135534|Drug|group B|mutonpain 0.1 mg/kg
15838639|NCT04135534|Drug|group C|mutonpain 0.2 mg/kg
15838640|NCT04135521|Drug|Intraperitoneal chemotherapy|Intraperitoneal or intravenous dose-dense platinum/taxane chemotherapy
15838641|NCT04135508|Drug|BAT1406|40mg/0.8ml
15838642|NCT04135508|Drug|Humira|40mg/0.8ml
15838643|NCT04135495|Drug|ELX-02|ELX-02 is a small molecule, new chemical entity being developed for the treatment of genetic diseases caused by nonsense mutations. ELX-02 is a eukaroyotic ribosomal selective glycoside (ERSG)
15838644|NCT04135482|Other|colonic tissue biopsy|colonic tissue biospy of patients with severe crohn's disease using colonoscopy
15838645|NCT04135469|Other|Referral for tax preparation services|Printed materials will be provided with contact information for tax preparation services at BMC and other sites in the city.
15838646|NCT04135469|Other|Navigator assisted tax preparation services at BMC|A study navigator will assist the participant in accessing the BMC located tax preparation services.
15838647|NCT04135456|Drug|Mannitol|When the neurosurgeon starts the skin incision, 20% mannitol administered through the venous catheter with fulldrip in 5-10 minutes. Neurosurgeons evaluate the degree of brain relaxation after dura opening in 4 point scale (1=bulging brain, 2=firm brain, 3=satisfactorily relaxed, 4=perfectly relaxed).
15838648|NCT04135443|Behavioral|3T Tune in! Turn on! Turn up!|A sex positive multimedia interactive mobile app delivered HIV/STI intervention developed for use by YBMSM ages 14-17. The program employs a theory based approach to address essential knowledge, perceptions of risk, peer norms, attitudes and skill with two primary goals: (1) To reduce HIV/STI the program emphasizes partner reduction, avoidance of concurrent partners, condoms and HIV/STI tests; and (2) To improve sexual health and relationships.
15838649|NCT04135443|Behavioral|General Health App|The control group will download a mobile app that addresses general health behaviors, specifically drinking more water.
15838650|NCT04135430|Other|Survey|practice of an updated questionnaire at D0, D2 and D7
15838651|NCT04135417|Biological|HAV|Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access.
15838652|NCT04135404|Other|health-related telephone surveys|The Behavioral Risk Factor Surveillance System (BRFSS) is a health-related telephone surveys that collect state data about United States residents regarding their health-related risk behaviors, chronic health conditions, and use of preventive services (Secondary-data analysis).
15838653|NCT04135391|Behavioral|Aerobic exercise training|All recruited subjects underwent 36 times of moderate-intensity continuous training (MICT) at 60% of peak oxygen consumption (VO2peak) for 30 mins, and 10or had high-intensity interval training (HIIT) at alternative 80% and 40% VO2peak with the same training times and duration.
15838654|NCT04135378|Drug|ascorbic acid|Study Group :- ascorbic acid ( 500 mg per day) for one week before presentation
15838655|NCT04135378|Other|placebo|:- included 30 students given placebo for one week before presentation.
15838656|NCT04135365|Behavioral|neurocognitive assessment|Observational study therefore there are no interventions
15838657|NCT04135365|Behavioral|neuroimaging assessment|Observational study therefore there are no interventions
15838658|NCT04135352|Drug|200 mg of pembrolizumab|Participants receive 200 mg of pembrolizumab intravenously Q3W for a maximum of 35 21-day cycles.
15838659|NCT04135352|Biological|V938|Participants receive V938 intratumorally in cycles 1-7. Each cycle is 21 days.
15838660|NCT04135339|Other|Eccentric exercise|The exercise session will consist of 3 sets of 15 reps, 3´´ per rep, with 30'' rest between sets, of the previous treated gastrocnemius muscle (by DN). Each rep will be a pure eccentric contraction.
15838661|NCT04135339|Other|Concentric exercise.|The exercise session will consist of 3 sets of 15 reps, 3´´ per rep, with 30'' rest between sets, of the previous treated gastrocnemius muscle (by DN). Each rep will be a pure concentric contraction.
15838662|NCT04135339|Other|Isometric exercise.|The exercise session will consist of 3 sets of 15 reps, 3´´ per rep, with 30'' rest between sets, of the previous treated gastrocnemius muscle (by DN). Each rep will be a pure isometric contraction.
15838663|NCT04135326|Other|Quality-of-Life Assessment|Ancillary studies
15838664|NCT04135326|Other|Questionnaire Administration|Ancillary studies
15838665|NCT04135326|Procedure|Transcranial Direct Current Stimulation|Undergo tDCS
15838666|NCT04135313|Drug|Capecitabine|2000 mg/m2, bid, per os, days 1-14
15838667|NCT04135313|Drug|Oxaliplatin|130 mg/m2 iv day 1
15838668|NCT04135313|Drug|Capecitabine|825 mg/m2, bid, per os, only on days of radiation (Monday through Friday)
15838669|NCT04135313|Radiation|Radiotherapy|Pelvic radiotherapy dose: 44 Gy on regional nodes, 54 Gy on primary tumor in 2 Gy fractions
15838670|NCT04135313|Procedure|Rectal cancer surgery|Laparoscopic or open total mesorectal excision or extralevator abdominoperineal resection
15838671|NCT04135300|Genetic|Single dose intravenous injection of BBM-H901|Single dose intravenous infusion of BBM-H901, an adeno-associated viral (AAV) vector designed to drive expression of the human factor IX (hFIX) transgene in liver. The dose of BBM-H901 will be 5x10'12 vg/Kg.
15838672|NCT04135287|Drug|GLP-1 receptor agonist|The main objective of the study is to determine the relationship between the increase in glucose-stimulated insulin secretion and decrease in HbA1c caused by GLP-1 RA therapy in poorly controlled T2DM patients. We also will identify a cut point of an increase in beta cell function which produces a clinically meaningful decrease in HbA1c.
15838677|NCT04135222|Diagnostic Test|Measurements of gingiva thickness|Measurements were performed at upper canines and incisors in thirty periodontally healthy patients. The CBCT/CAD technology along with the PDIP software were used to measure crestal (CGT in mm ), supracrestal (SGT in mm) and free gingival thickness (FGT in mm ) as well as alveolar crest-gingival margin (AC-GM) and cemento-enamel junction (AC-CEJ) distance and the TLPAC localized 2, 4 and 8mm apically than the edge of the AC. Width of keratinized tissue (WKT) were measured using a periodontal probe. For each patient, the periodontal phenotype was evaluated on the basis of coronal width/length (CW/CL in percentages) ratio of both upper central incisors. For each tooth, the gingival phenotype was assessed on the basis of the GT measurement( in mm).
15838678|NCT04135209|Diagnostic Test|Optical coherence tomography angiography OCTA|Macular scanning using regular structural OCT as well as microvasculature analysis using OCTA
15838679|NCT04135196|Other|voluntary forearm loading task|voluntary task, consisting of leaning onto the palm of the hand until a target force is reached. Each loading bout consists of 100 loading cycles, which takes approximately 2 minutes to complete. The task is performed 4 times per week during the intervention period.
15838680|NCT04135183|Procedure|changes of Pneumonia Severity Score|assessing effectiveness of CAP treatment by using continuous pneumonia severity score
15838681|NCT04135170|Combination Product|ALBC vs plain bone cement|The patients undergoing full-cemented primary total knee arthroplasty are allocated to either ALBC or plain bone cement and compare the effectiveness of ALBC use vs pain bone cement bone cement without antibiotic) with respect to revision due to PJI one year after primary TKA surgery.
15838682|NCT04135157|Procedure|Pectoralis nerve block II|PECS II block will be performed 30 min. before general anesthesia.
15838683|NCT04135157|Procedure|Erector spine plane block|ESP block will be performed 30 minutes before general anesthesia.
15838684|NCT04135157|Other|Control|Only general anesthesia will be performed.
15838685|NCT04135144|Other|Group 1 (printed materials)|Exercises were given at least 3 times a week for 10 weeks and 1 set per day for a total of 6 weeks. individuals; normal joint movement exercises; neck flexion, lateral flexion, rotation, extension and retraction movements, isometric exercises; neck flexion, extension, lateral flexion and rotation movements and stretching exercises; neck lateral flexion, neck rotation and flexion movements were given.
15838686|NCT04135144|Other|Group 2 (video phone reminder)|Exercises were given at least 3 times a week for 10 weeks and 1 set per day for a total of 6 weeks. individuals; normal joint movement exercises; neck flexion, lateral flexion, rotation, extension and retraction movements, isometric exercises; neck flexion, extension, lateral flexion and rotation movements and stretching exercises; neck lateral flexion, neck rotation and flexion movements were given.
15838687|NCT04135131|Other|pilates mat exercises and home exercises|Patients with low back pain were randomized into pilates (group 1) or home exercise group (group 2) 3 times/week for 8 weeks. Pilates mat exercise program comprised three sessions a week for 8 weeks (Monday, Wednesday, and Friday), with each session being scheduled for 1 h (5-min warm-up, 50-min exercise, and 5-min cooling) and each set comprising 10 repetitions. The home exercise program included the pelvic tilt in the supine position, hamstring stretch, hip flexors and lumbar extensor stretch, bridge, strengthening the abdominal muscles, cat/camel exercises in the crawl position, leaning on the forearms in the prone position, strengthening the back extensors, and crossed-arms/legs lift exercises.
15838688|NCT04135105|Other|Normal hearing group|Observational
15838689|NCT04135092|Biological|Individual Patient TCR Transduced PBL|Day 0: Cells will be infused at a dose not to exceed .5e11 in 400 mL IV on the Patient Care Unit over 20-30 minutes (2-4 days after the last dose of fludarabine).
15838690|NCT04135092|Drug|Cyclophosphamide|Days -7 and -6: Cyclophosphamide 60 mg/kg/day x 2 days IV in 250 mL D5W infused simultaneously with mesna 15 mg/kg/day over 1 hour x 2 days.
15838691|NCT04135092|Drug|Fludarabine|Days -7 to -3: Fludarabine 25 mg/m2 /day IVPB daily over 30 minutes for 5 days.
15838692|NCT04135092|Drug|Aldesleukin|Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 4 days (maximum 10 doses).
15838693|NCT04135092|Drug|Pembrolizumab|Pembrolizumab 2 mg /kg IV over approximately 30 minutes on Day -2 and then every 3 weeks until time of disease progression.
15838694|NCT04135053|Biological|Lyophilised Neisseria lactamica|Previously lyophilised Neisseria lactamica will be reconstituted and intranasally given to participants
15838695|NCT04135040|Dietary Supplement|L-Amino Acid|8 different lysine intakes (L-Amino Acid and food) will be tested for 8 hours each.
15838696|NCT04135027|Other|no interventions|no interventions
15838697|NCT04135014|Drug|Midazolam|oral midazolam 0.5mg.kg-1 approximately 30-40 minutes before surgery using a computer-generated random number table.
15838698|NCT04135014|Drug|Dexmedetomidine|intranasal dexmedetomidine 2µg.kg-1 approximately 30-40 mins before surgery using a computer-generated random number table.
15838699|NCT04135014|Drug|Midazolam and Dexmedetomidine|oral midazolam 0.5mg.kg-1 and intranasal dexmedetomidine 1ug.kg-1 approximately 30-40 mins before surgery using a computer-generated random number table.
15838700|NCT04135001|Behavioral|HBM Training|A computer-based training to reduce hostile bias and interpersonal conflict as a mechanism to improve trust and cohesion within an operational military unit across the deployment cycle. The computer training is based on the Go/No-Go task (Fillmore et al., 2006) and Lexical Decision Task (Lepore & Brown, 2002). The training reduces HAB by affecting two cognitive mechanisms: prime seeking non-hostile concepts when presented with ambiguous cues and conditioning inhibition in response to hostile cues. Thus, the training induces a non-hostile attribution bias while simultaneously training the inhibition of hostile attribution bias and aggressive behavior in response to ambiguous cues.
15838701|NCT04135001|Other|Placebo Training|Volunteers in the placebo condition will be told to complete the fragments with the first word that comes to mind. This placebo still exposes volunteers to the training stimuli and computer task, but does not train inhibition or selectively prime non-hostility, which are the hypothesized mechanisms of the training.
15838702|NCT04134988|Other|Medimoov|The Medimoov game platform (created by NaturalPad©) is a physio-gaming medical device, which comes in the form of functional and postural rehabilitation software. Associating movement capture and videogames, Medimoov contributes to the older adults' motivation and engagement and offers adapted physical activities.
15838804|NCT04134117|Biological|Tisagenlecleucel|One time single predetermined dose level CAR-positive T cells will be utilized based on the FDA approved product label.
15838703|NCT04134988|Other|Standard psychomotor therapy|Psychomotor therapists are among the professionals recommended by the French national health authority. They intervene on psychomotor dimensions of falls, namely the motor, sensory and cognitive aspects.
15838704|NCT04134975|Procedure|Spine surgery|surgery with pedicle screw placement between L1 and S1
15838705|NCT04134962|Diagnostic Test|3D Imaging FAO measurement and Clinical evaluation of the hindfoot alignment|"The Cone Beam under load is used for the diagnosis and monitoring of the foot and ankle. It has a CE marking for this purpose.
~The images obtained by the Cone Beam under load (Ped Cat) will be analysed using the TALAS mathematical algorithm tool to measure the FAO.
~The internal software of the Cone Beam under load will also be used to obtain a radiographic image corresponding to a 2D projection on which the tibio-calcaneal angle can be measured."
15838706|NCT04134949|Behavioral|Cognitive Behavior Therapy|consists of eight weekly treatment sessions of 45 to 60 minutes.
15838707|NCT04134949|Behavioral|Mindfulness-Based Cognitive Therapy|consists of eight weekly treatment sessions of 45 to 60 minutes.
15838708|NCT04134936|Drug|Tafasitamab|Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) in addition to R-CHOP
15838709|NCT04134936|Drug|Tafasitamab plus lenalidomide|Six 21-day cycles of tafasitamab (12 mg/kg intravenously, on Day 1, 8 and 15) plus lenalidomide (starting dose 25 mg orally, on Day 1-10) in addition to R-CHOP
15838710|NCT04134923|Drug|[11C] Pittsburgh Compound-B (PIB)|Participants will receive a single intravenous bolus injection of 6.0 - 20.0 mCi (222-740 MBq) of the investigational radiotracer [11C] PIB. Participants will then undergo a [11C] PIB PET/CT scan conducted in the Center for Clinical Imaging Research (CCIR) facility.
15838711|NCT04134910|Procedure|Physical Therapy|Subjects will be prescribed a 6-week physical therapy regimen consisting of one 45 minute in office visit per week, and home exercises performed daily. The in-office visits with a physical therapy provider will consist of the application of manual therapy, particularly high-velocity, low amplitude thrust mobilization in the anterior/posterior direction of the lumbar spine. In office visits will also include supervised repeated motion of the lumbar spine into extension (McKenzie therapy, 3 sets of 10 repetitions, in prone and standing positions) Patients will be instructed to complete these repeated extension exercises at home daily for the 6 week period.
15838712|NCT04134897|Drug|Capecitabine|2000 mg/m2, bid, per os, days 1-14, 4 cycles
15838713|NCT04134897|Drug|Oxaliplatin|130 mg/m2 iv day 1, 4 cycles
15838714|NCT04134897|Drug|Capecitabine|825 mg/m2, bid, per os, only on days of radiation (Monday through Friday)
15838715|NCT04134897|Radiation|Radiotherapy|Pelvic radiotherapy dose: 44 Gy on regional nodes, 50 Gy on primary tumor
15838716|NCT04134897|Procedure|Rectal cancer surgery|Laparoscopic or open total mesorectal excision
15838717|NCT04134897|Radiation|Radiotherapy|Pelvic radiotherapy dose: 25 Gy in 5 Gy fractions
15838718|NCT04134884|Drug|Talazoparib|Talazoparib will be taken on days 4-21, 6-21 or 1-21 at a dose level of 0.25, 0.5, 0.75 or 1.0 mg depending on cohort assignment
15838719|NCT04134884|Drug|ASTX727|ASTX727 will be taken on days 1 and 3, days 1,3,5 or days 1 through 5 of the 28 day cycle at doses of 10 mg:100 mg or 15 mg:100 mg depending on cohort assignment
15838720|NCT04134871|Behavioral|Group walk and one to one coaching|Participants will be invited to attend a group education session, weekly group walks and fortnightly coaching sessions
15838721|NCT04134858|Other|The nurse-led health coaching program|The intervention was based on the customized nurse-led health-coaching program. The program consisted of an individual health-coaching nurse, health-coaching sessions and a written action plan according to each participant´s individual needs.
15838722|NCT04134845|Drug|Dantrolene/Ryanodex|muscle relaxant
15838723|NCT04134845|Drug|Placebo|Controlled placebo of saline administered Intravenous; 1 mg/kg IV over 3 minutes, one time dose
15838724|NCT04134793|Procedure|radiofrequency ablation|bipolar radiofrequency ablation by ablation forceps
15838725|NCT04134767|Behavioral|Health Linkage|Research staff will: 1) help participants set goals and reduce their health risks by helping them to reflect on personal drug use, sexual relationships, and their consequences in the context of personal values and goals; 2) help link participants to services that they need and want; 3) offer participants the option of HIV and hepatitis C testing, provide the test result, and provide post-test counseling; and 4) provided participants nasal spray naloxone (Narcan) to carry with them in case they encounter someone who has an opioid overdose or in case they have an opioid overdose and a friend can use the naloxone to respond.
15838726|NCT04134767|Behavioral|Overdose Education|Participants will complete a 10-minute overdose education training video on preventing, recognizing, and responding effectively to an opioid OD.
15838727|NCT04134754|Other|6% Carbon dioxide/50% oxygen/balance nitrogen mixture|In the hypercapnic ventilatory response (HCVR) test, the subject will rebreathe a gas mixture that has 6% carbon dioxide and 50% oxygen. This test has been performed for decades for research and clinical purposes. The effects of carbon dioxide inhalation are short lived and do not cause long term consequences. the hypercapnic ventilatory response (HCVR), we will have you
15838728|NCT04134741|Other|Kinetic Control|"The Kinetic Control training included a functional examination of motor disorders and individual training. The KC training included active exercises, active exercises with torso muscle resistance and exercises involving lower limbs.
~The duration of one training was 20-30 minutes."
15838729|NCT04134728|Biological|GSK3196165 (Otilimab)|GSK3196165 solution in vial/pre-filled syringe (PFS) to be administered SC.
15838730|NCT04134728|Biological|Sarilumab|Sarilumab solution in PFS to be administered SC.
15838731|NCT04134728|Drug|Placebo to GSK3196165/ Sarilumab|Placebo sterile 0.9 percentage (%) weight by volume (w/v) sodium chloride solution in vial/PFS to be administered SC.
15838732|NCT04134728|Drug|csDMARDs|Stable dose of csDMARD(s) as SoC.
15838733|NCT04134715|Drug|PF-06826647|100 mg tablet
15838734|NCT04134715|Drug|Oral Contraceptive (OC)|OC in the form of 1 PORTIA (30 µg EE and 150 µg LN) or equivalent tablet
15838735|NCT04134702|Other|Acupuncture|Acupuncture and ear acupuncture using indwelling fixed needles, that will remained in situ several days after surgery until the patients will experience pain
15838736|NCT04134689|Device|DOT Selfie Intervention|This comprises a smart phone, the VDOT App, a prepaid weekly internet bundle and text message medication reminders
15838737|NCT04134689|Other|In-person DOT|Directly observed TB treatment by a health-worker either in a patient's home or at an agreed upon location within the community.
15838738|NCT04134676|Drug|Conditioned Media|Conditioned Media represents the complete regenerative milieu of cell-sourced secretome and vesicular elements. The soluble components of the secretome may be separated from the microvesicle fraction by centrifugation, filtration, polymer precipitation-based methodologies, ion exchange chromatography and size-exclusion chromatography. Both of these components may be capable of independently triggering regeneration and repair as well as of mediating the de novo organogenesis of tissue-engineered organs ex vivo.
15838739|NCT04134663|Drug|vasoconstrictor and oxytocin treatment|intransal administration of vasoconstrictor and oxytocin
15838740|NCT04134663|Drug|vasoconstrictor's placebo and oxytocin treatment|intransal administration of vasoconstrictor's placebo and oxytocin
15838741|NCT04134663|Drug|vasoconstrictor and oxytocin's placebo treatment|intransal administration of vasoconstrictor and oxytocin's placebo
15838742|NCT04134650|Combination Product|Linagliptin + metformin|Linagliptin-Metformin 2.5/1700mg daily plus a lifestyle modification program based on nutritional assesment, physical activity prescription and general counseling
15838743|NCT04134650|Drug|Metformin|Metformin 1700mg daily plus a lifestyle modification program based on nutritional assesment, physical activity prescription and general counseling
15838744|NCT04134637|Device|ultrasound|in the PIFB group linear ultrasound (Philips clear vue350,Philips healthcare,Andover MAO1810,USA,Machine Identification number:1385,Nile medical center,service@nilemed.net) probe will be used.
15838745|NCT04134637|Drug|Bupivacaine Hydrochloride 5 MG/ML|twenty milliliters of a solution of 0.25% bupivacaine in the PIFB group
15838746|NCT04134624|Other|Sepsis care bundle|Initiation of sepsis care bundle in prehospital setting, including collection of blood cultures, administration of antibiotics, and initiation of IV fluids
15838747|NCT04134611|Device|Hyaluronic acid injection|Injection of Hyaluronic acid in knees of those who has degenerative changes after arthroscopic treatment of lateral patellar compression syndrome
15838748|NCT04134611|Device|No injection of Hyaluronic acid|No injection of Hyaluronic acid was done
15838749|NCT04134598|Radiation|Partial Breast Irradiation (PBI)|Irradiation of volume's portion of the residual breast (index quadrant).
15838750|NCT04134598|Drug|Endocrine Therapy (ET): letrozole, anastrozole, exemestane, tamoxifen|Adjuvant endocrine therapy as per local policy (letrozole/anastrozole/exemestane/tamoxifene for 5-year or switch schedules aromatase inhibitors/tamoxifen for 5-year).
15838751|NCT04134585|Other|semi-structured interviews|Semi-structured interviews will be performed to determine representations of physical activity, reluctance/motivation to participate in physical activity sessions and facilitators who can help them overcome these barriers.
15838752|NCT04134559|Drug|Pembrolizumab|Pembrolizumab will be administered every 3 weeks, at predetermined dose with 21 consecutive days defined as a treatment cycle.
15838753|NCT04134546|Procedure|CBD exoloration|Early versus late intervention after biliary tract injury post cholecystectomy
15838754|NCT04134533|Other|Gross Motor Function Measurement|These instruments will be used for determine the gross motor functional level and quality of life of the children with cerebral palsy and anxiety, depression levels of caregivers.
15838755|NCT04134520|Device|ProLung System|Non-invasive bioconductance measurements
15838756|NCT04134494|Device|Ablative Fractional 2940 nm Laser|"Treatment visit 1, month 0: On the first pass, the depth of the laser will be from 300 to 500 microns, or the thickness of 3 to 5 sheets of paper; the depth will be based on the biopsy that was used to diagnosis the lichen sclerosus. On the second pass, the depth will be 50 microns deeper than the first pass and the hand piece rotated 45˚.
~Treatment visit 2, month 1: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚.
~Treatment visit 3, month 2: The first pass of the laser will be the same depth as the second pass from the last visit. The second pass will be 50 microns deeper and the hand piece rotated 45˚."
15838757|NCT04134468|Drug|Pegvorhyaluronidase alfa|IV infusion
15838758|NCT04134468|Drug|Abraxane|IV infusion
15838759|NCT04134468|Drug|Gemcitabine|IV infusion
15838760|NCT04134455|Procedure|Mesh reinforcement|Once the surgery is over. The closure is made with the 4: 1 rule, then an onlay mesh is placed that exceeds 3 cm on each side the wound is fixed with suture.
15838761|NCT04134455|Procedure|RTL reinforcement|Once the surgery is finished, the ared is reinforced by placing a longitudinal suture parallel to the edge of the wound 0.5 cm, then the wound is closed with a 4: 1 rule but the suture enters lateral to the reinforcement suture
15838762|NCT04134442|Drug|Bupivacaine Liposome Injection [Exparel]|"Standard pre-operative and post-operative medical regimen including standing acetaminophen 650mg q6hours, gabapentin 300mg q8hours and as needed oxycodone every 4 hours (unless there are contraindications due to liver function, kidney function, age, or current therapy as currently determined by APS anesthesiologist)
~Pre-operative ultrasound guided ISNB with a 20ml mixture consisting of 10ml of 0.5% bupivacaine with epinephrine 1:200,000, and 10ml of BL 1.33%"
15838763|NCT04134442|Drug|Standard Therapy|"Standard pre-operative and post-operative medical regimen including standing acetaminophen 650mg q6hours, gabapentin 300mg q8hours and as needed oxycodone every 4 hours (unless there are contraindications due to liver function, kidney function, or age as currently determined by acute pain service (APS) anesthesiologist)
~Preoperative, ultrasound guided ISNB with a bupivacaine mixture: 20ml 0.5% bupivacaine and epinephrine 1:200,000."
15838764|NCT04134429|Device|Everion|The Everion® device, by Biovotion, Zurich, is a on-skin wearable device measuring health data.
15838765|NCT04134416|Drug|Donepezil|Donepezil shall be administered at the times stipulated in the study design as follows: one 5 mg tablet at night for 4 weeks and then one 10 mg tablet at night until the end of the trial (week 10).
15838766|NCT04134416|Behavioral|Intensive-Language Action Therapy|All patients participating in the study will receive in weeks 9 and 10 daily three and a half hours of ILATplus therapy. This therapy consists of 30 minutes of specific repetition training (tailored and reinforced by the therapist) before starting with classic ILAT for 3 hours/day during 10 consecutive days.
15838805|NCT04134104|Procedure|Surgery for Colorectal malignant diseases either LAR or APR|Patients following LAR or APR were observed for the Bowel, Bladder, and Sexual Dysfunction
15838806|NCT04134091|Drug|LPCN 1144 Formulation A|Oral LPCN 1144 Formulation A capsule, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose)
15839763|NCT04126187|Device|Panoptix|Panoptix trifocal intraocular lens (IOL)
15838767|NCT04134416|Device|Transcranial direct current stimulation|Transcortical direct current stimulation (tDCS) will be applied using a STARSTIM neurostimulation device (Neuroelectrics, Barcelona). Each participant will receive either anodal or sham 20-minute sessions while receiving ILATplus. In the sham stimulation, the same helmet and electrode that is used in the active stimulation will be placed but, in this case, we will apply only a slight current at the beginning and end of the session with the objective of simulating the effects that are experienced with the active stimulation without producing significant cortical stimulation. The active electrode will be placed in the region of the lower right frontal rotation and the reference electrode in the extraencephalic zone (left clavicle). Combined rehabilitation sessions (ILATplus/tDCS) will be conducted, as indicated above, in weeks 9 and 10 of the trial.
15838768|NCT04134403|Drug|STASIS|Hydrocortisone sodium succinate, 50 mg, every 6 hours, 7 days or until ICU discharge Thiamine, 200 mg, every 12 hours, 4 days or until ICU discharge Ascorbic acid, 1,500 mg, every 6 hours, 4 days or until ICU discharge
15838769|NCT04134390|Drug|Cabozantinib|Subjects will receive cabozantinib 40mg p.o. as long as they continue to experience clinical benefit or until unacceptable toxicity, the need for alternative anticancer treatment, or other reasons for treatment discontinuation
15838770|NCT04134377|Other|Protein Food Snack|The intervention is 6-months using a food snack with control being three months prior to and three months after-study invention whereby serum albumin levels will be collected monthly. If patients are participating in a supplement program, they will be maintained throughout all ten months of the study so long as the criteria for the supplement program (enrollment and discontinuation) is still being met.
15838771|NCT04134364|Drug|Sodium alginate|3 days oral administration of sodium alginate after gastric biopsy
15838772|NCT04134351|Other|Bronchial challenge test|Bronchial challenge test with sphingosine-1-phosphate
15838773|NCT04134338|Other|To evaluate the effect of wound infection on costs|the degree of costs that is required for trating wound infection
15838774|NCT04134325|Biological|Nivolumab|Nivolumab administered at 240mg every two weeks or 480 mg every four weeks as per standard of care after treatment with CD30.CAR T cells
15838775|NCT04134325|Biological|Pembrolizumab|Pembrolizumab administered at 200 mg every three weeks or 400 mg every six weeks as per standard of care after treatment with CD30.CAR T cells
15838776|NCT04134312|Biological|MVA-BN-Brachyury|MVA-BN-Brachyury will be administered intravenously every three weeks with three administrations in total at the dose indicated by the enrolled cohort.
15838777|NCT04134299|Dietary Supplement|AXA4010|The study will initiate with approximately eight (8) adult subjects (≥18 y/o) with SCD (Cohort 1). Each subject will receive AXA4010 twice a day (BID) for 12 weeks. Safety and tolerability will be monitored, and study procedures will be performed. Analysis of safety, tolerability and laboratory assessments at week 12 would be performed. Based on the 12-week observations from at least three subjects in Cohort 1, subsequent Cohorts 2 and 3 in Part II may be initiated.
15838778|NCT04134273|Drug|CLPG Topical Gel 1%|Clindamycin Phosphate Topical Gel 1% (Taro Pharmaceuticals U.S.A, Inc.)
15838779|NCT04134273|Drug|Clindamycin|Clindamycin Phosphate topical gel 1%
15838780|NCT04134273|Drug|Placebo|Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)
15838781|NCT04134260|Drug|Abiraterone Acetate|Given PO
15838782|NCT04134260|Drug|Apalutamide|Given PO
15838783|NCT04134260|Drug|Hormone Therapy|Receive hormone therapy
15838784|NCT04134260|Drug|Prednisone|Given PO
15838785|NCT04134260|Other|Quality-of-Life Assessment|Ancillary studies
15838786|NCT04134260|Other|Questionnaire Administration|Ancillary studies
15838787|NCT04134260|Radiation|Radiation Therapy|Undergo pelvis and prostate bed radiation therapy
15838788|NCT04134247|Drug|PD-1 combined with chemotherapy|"PD-1 200 mg，d1; Rituximab 375mg/m2，d0（ the same as the chemotherapy group）
~The chemotherapy chooses one of the following:
~GDP：Gemcitabine 800-1000mg/m2, d1、8; Cisplatin 25mg/m2, d1-3; Dexamethasone 40mg, d1-4; GemOx：Gemcitabine 800-1000mg/m2, d1、8; Oxaliplatin 130mg/m2，d1; DA-EPOCH：Epirubicin 15mg／m２ ,d1-4; Etoposide 50mg／m２ ,d1-4; Vincristine 0.4mg/ ｍ２ ，d1-4; Cyclophosphamide 750mg/ ｍ２ , d５; Prednisone 60mg/m２/d, d1-5; ICE: Ifosfamide 1g/m２，d1-4; Cisplatin 25mg/m２, d1-4; Etoposide 60 mg／m２，d1-4; DICE: Ifosfamide 1 g／m２，dl-d4; Cisplatin 25mg/m２, d1-4; Etoposide 60 mg／m２，d1-4; Dexamethasone 10-20mg，d1-4; High dose MTX（Central recurrence）：MTX 3.5g／ｍ２,ｄ1; Hyper CVAD（B）：MTX 1g／ｍ２, d1; Cytarabine 2-3g／ｍ２, q12h, d2-3"
15838789|NCT04134247|Drug|chemotherapy|"Rituximab 375mg/m2，d0（ Except for patients who relapsed within12 months after the last application of rituximab）
~The chemotherapy chooses one of the following:
~GDP：Gemcitabine 800-1000mg/m2, d1、8; Cisplatin 25mg/m2, d1-3; Dexamethasone 40mg, d1-4; GemOx：Gemcitabine 800-1000mg/m2, d1、8; Oxaliplatin 130mg/m2，d1; DA-EPOCH：Epirubicin 15mg／m２ ,d1-4; Etoposide 50mg／m２ ,d1-4; Vincristine 0.4mg/ ｍ２ ，d1-4; Cyclophosphamide 750mg/ ｍ２ , d５; Prednisone 60mg/m２/d, d1-5; ICE: Ifosfamide 1g/m２，d1-4; Cisplatin 25mg/m２, d1-4; Etoposide 60 mg／m２，d1-4; DICE: Ifosfamide 1 g／m２，dl-d4; Cisplatin 25mg/m２, d1-4; Etoposide 60 mg／m２，d1-4; Dexamethasone 10-20mg，d1-4; High dose MTX（Central recurrence）：MTX 3.5g／ｍ２,ｄ1; Hyper CVAD（B）：MTX 1g／ｍ２, d1; Cytarabine 2-3g／ｍ２, q12h, d2-3"
15838790|NCT04134221|Diagnostic Test|Ultrasound assessment|Ultrasound assessment of internal carotid artery blood flow
15838791|NCT04134208|Procedure|Computed Tomography|Undergo PET-CT scan
15838792|NCT04134208|Drug|Fluciclovine F18|Given IV
15838793|NCT04134208|Procedure|Positron Emission Tomography|Undergo PET-CT scan
15838794|NCT04134195|Device|Transcranial direct current stimulation|2mA stimulation for 20 minutes
15838795|NCT04134182|Drug|Nivolumab|3 mg/kg intravenously every 2 weeks during 16 weeks
15838796|NCT04134182|Drug|Ipilimumab|1 mg/kg intravenously every 3 weeks for four doses
15838797|NCT04134169|Other|Not applicable(observational study)|Not applicable(observational study)
15838798|NCT04134156|Procedure|sleeve gastrectomy|5-port sleeve gastrectomy
15838799|NCT04134156|Procedure|one anastomosis gastric bypass|5-port one anastomosis gastric bypass
15838800|NCT04134143|Biological|ExpressGraft-C9T1 Skin Tissue|A round patch of experimental skin tissue that the doctor applies over the ulcer
15838801|NCT04134130|Drug|Degarelix 120 MG [Firmagon]|Two doses of degarelix, 240 mg, subcutaneously once, at study start.
15838802|NCT04134130|Drug|Gonal F RFF Pen 900 UNT Per 1.5 ML Pen Injector|Gonal-f 300 IU subcutaneously 3 times per week for 5 weeks.
15838807|NCT04134091|Drug|LPCN 1144 Formulation B|Oral LPCN 1144 Formulation B capsule, total daily dose of 450 mg testosterone undecanoate administered as BID (225 mg testosterone undecanoate per dose)
15838808|NCT04134091|Drug|Placebo|Oral matching placebo capsule administered as BID
15838809|NCT04134078|Drug|inhaled nitric oxide|Inhaled nitric oxide at 40 ppm will be administered upto 24 hours post ROSC in patient who developed in hospital cardiac arrest
15838810|NCT04134065|Drug|Vitamin D|patients with refractory Crohn disease and a serum 25(OH)D concentration <75 nmol/L were prescribed oral liquid vitamin D supplementation over 12 weeks using a specific protocol with dose adjusted 4-weekly to aim for a target level of 100e125 nmol/L.
15838811|NCT04134065|Drug|Placebo oral capsule|the capsule contain nothing
15838812|NCT04134052|Drug|ketamine sedation versus midazolam sedation|Sedation with ketamine 5-20 mcg / kg / hr in infusion in 100ml Na Cl solution 0.9% during surgery and the second midazolam group 5 mcg- 35 mcg / kg / hr in infusion in 100ml Na Cl solution 0.9% will be administered during surgery
15838813|NCT04134039|Device|Polyurethane (PU) condom|A minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to couples to be used during vaginal intercourse over a 4 week period, the assessment period. Couples will repeat the assessment period each of the 2 condom types.
15838814|NCT04134039|Device|Natural Rubber Latex (NRL) condom|A minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to couples to be used during vaginal intercourse over a 4 week period, the assessment period. Couples will repeat the assessment period each of the 2 condom types.
15838815|NCT04134026|Drug|HIF-PHI|Drug will be dosed orally three times a week.
15838816|NCT04134026|Drug|Epoetin Alfa|The drug will be dispensed per the package insert or the country-specific product labeling.
15838817|NCT04134013|Dietary Supplement|Combination: Nutrition AND Chiropractic Adjustment|LBP chiropractic adjustment per protocol, nutrition counseling/ 4 Nutrient offerings (Vitamin Booster, Shake + 2 other offerings)
15838818|NCT04134013|Other|Chiropractic Adjustment: Spinal Manipulation Therapy|LBP chiropractic adjustment per protocol
15838819|NCT04134000|Drug|Atezolizumab|1200 mg IV q3w until recurrence of disease, disease progression (e.g., muscle-invasive or metastatic UBC), symptomatic deterioration (i.e., uncontrollable pain secondary to disease or unmanageable ascites, etc.) attributed to disease progression as determined by the investigator, Intolerable toxicity related to atezolizumab, including development of an immune-mediated adverse event determined by the investigator to be unacceptable given the individual patient's potential response to therapy and severity of the event, any medical condition that may jeopardize the patient's safety if he or she continues on study treatment, use of another non-protocol anti-cancer therapy or pregnancy.
15838820|NCT04134000|Drug|BCG|1 or 1/2 instillation per week until recurrence of disease, disease progression (e.g., muscle-invasive or metastatic UBC), symptomatic deterioration (i.e., uncontrollable pain secondary to disease or unmanageable ascites, etc.) attributed to disease progression as determined by the investigator, Intolerable toxicity related to atezolizumab, including development of an immune-mediated adverse event determined by the investigator to be unacceptable given the individual patient's potential response to therapy and severity of the event, any medical condition that may jeopardize the patient's safety if he or she continues on study treatment, use of another non-protocol anti-cancer therapy or pregnancy.
15838821|NCT04133987|Biological|Tetravalent live attenuated dengue vaccine admixture TV005|The admixtures of the candidate vaccines each contain 4 live attenuated dengue viruses, each of a different serotype.
15838822|NCT04133987|Biological|Placebo|PLASMA-LYTE A Injection pH 7.4 (Multiple Electrolytes Injection, Type 1, USP) is a sterile, nonpyrogenic isotonic solution in a single dose container for intravenous administration.
15838823|NCT04133974|Behavioral|methadone induced memory retrieval-extinction procedure|Drug memory is not invariably stable and can be induced transiently labile again by drug-related cues or drug itself, which is termed as 'reconsolidation'. Previously we and other groups have demonstrated that extinction coincided with reconsolidation weakened the drug memory and decreased drug craving and relapse. In the present study, we tried to interfere the methadone-induced heroin addiction memory reconsolidation by extinction given at different times following methadone administration.
15838824|NCT04133961|Drug|Phenylephrine|Phenylephrine infusion 0.3ml/kg/hour (equivalent to 0.5mcg/kg/min, phenylephrine dilution is 100mcg/ml in 20ml syringe)
15838825|NCT04133961|Drug|Normal saline|Normal saline infusion 0.3ml/kg/hour (normal saline in 20ml syringe)
15838826|NCT04133948|Drug|Domatinostat|"Patients in arm B and C will receive domatinostat 200 mg BID, days 1-14 q3weeks.
~Patients in arm D will start with once daily (OD) dosing scheme of domatinostat 200mg, d1-14 q3wks. Based on safety data of the first 5 patients in this arm, the next patients will be treated with either a higher dosing scheme (200mg BID, d1-14, q3wks), a lower dosing scheme (100mg OD, d1-14, q3wks) or the same dosing scheme (200mg OD, d1-14, q3wks)."
15838827|NCT04133948|Drug|Nivolumab|2 courses nivolumab 240 mg q3weeks
15838828|NCT04133948|Drug|Ipilimumab|2 courses ipilimumab 80 mg q3weeks
15838829|NCT04133935|Procedure|Laparoscopic Obturator Urethropexy|Suspending the periurethral vaginal tissue to the obturator internus fascia bilaterally via sutures, creating a support for the bladder neck compartment.
15838830|NCT04133935|Procedure|Burch Urethropexy|Suspending the periurethral vaginal tissue to Cooper's ligament bilaterally via sutures, creating a support for the bladder neck compartment
15838831|NCT04133922|Drug|GLP-1|glucagon-like peptide 1
15838832|NCT04133922|Drug|Insulin|we are using to replace basal insulin and to raise insulin concentrations during the insulin clamp
15838833|NCT04133922|Drug|Dextrose 20 % in Water|We are using Dextrose to maintain Euglycemia during the insulin clamp
15838834|NCT04133909|Drug|Placebo|Placebo is a 0.9% sodium chloride solution. It will be administered as a subcutaneous (SC) injection delivered once every 4 weeks using a pre-filled safety syringe.
15838835|NCT04133909|Biological|Mepolizumab|Mepolizumab is a sterile liquid formulation. It will be administered as a SC injection (100 mg/mL) delivered once every 4 weeks using a pre-filled safety syringe.
15838836|NCT04133896|Diagnostic Test|IL-6, Clusterin, Irisin Level|Blood samples to determine levels of Circulating IL-6, Clusterin and Irisin
15838837|NCT04133883|Procedure|Ultrasound, Haemophilia Joint Health Score|Systematic joint examinations of ankles, knees and elbows
15838838|NCT04133857|Other|aerobic exercise|aerobic exercise HIIT : High intensity interval training SSMIT : Steady state moderate intensity training
15838839|NCT04133844|Biological|Blood sample|Blood sample collection from a peripheral catheter at ECMO initiation (H0), then 2h, 6h, 12h, 24h and daily from day 2 to day 7 or at ECMO discontinuation
15838840|NCT04133831|Other|Total Survival|"The overall or total survival rate at each center is displayed in the table of outcome statistics.
~Total survival is computed from survival rates of both transplant and waitlist patients: [(number of patients surviving after transplant at end of year + number of patients alive on waitlist at end of year)] / [number of patients alive on waitlist at start of year]."
15838841|NCT04133831|Other|Stratified Transplant Survival|"The transplant survival rate in the table of outcome statistics is stratified into two groups: (i) patients who received excellent donor organs and (ii) patients who received less than optimal donor organs.
~Stratified transplant survival is computed from survival rates of transplant patients who received each quality category of organ.
~excellent transplant survival = [number of patients surviving after transplant with excellent organ]/[number of patients for whom excellent organ was accepted for transplant] marginal transplant survival = [number of patients surviving after transplant with marginal organ]/[number of patients for whom marginal organ was accepted for transplant]"
15838842|NCT04133818|Behavioral|Multidisciplinary education and exercise therapy program|"Multidisciplinary program: one and a half day of education and exercise therapy about low back pain :
~Lectures and explanations about low back pain
~Physical activity
~Relaxation"
15838843|NCT04133805|Dietary Supplement|viscous fiber|ex. barley b-glucan, oat b-glucan, konjac glucomannan, psyllium, guar gum, and pectin
15838844|NCT04133792|Drug|Simvastatin 40mg|40 mg orally daily for 5 years.
15838845|NCT04133792|Drug|Placebo oral tablet|40 mg orally daily for 5 years.
15838846|NCT04133779|Procedure|neurological examination, Kurtzke EDSS, Barthel scale, ecocolor-Doppler|For the subjects diagnosed with MS (group A), who did not need to be in a period of clinical relapse of the disease (at least 30 days from the last clinical relapse), the duration and the form of the disease was indicated (CIS, RR, SP or PP). The Investigator has submitted these subjects to a neurological examination which included the standard neurological examination, the Kurtzke EDSS (Kurtzke Expanded Disability Status Scale) comprising the functional systems of Kurtzke and the Barthel scale. After completing the selection phase following the previous examinations, the subjects were directed towards the qualified practitioner for the ecocolor-Doppler examination which was performed in blind.
15838847|NCT04133779|Procedure|neurological evaluation, ecocolor-Doppler|For the subjects affected by OND and ONDi, as in the groups C and D respectively, the Investigator has performed, beside the anamnesis and the physical examination, a specific neurological evaluation which included the compilation of the Barthel scale for the disability evaluation. After completing the selection phase following the previous examinations, the subjects were directed towards the qualified practitioner for performing the ecocolor-Doppler examination which was performed in blind.
15838848|NCT04133779|Procedure|medical history, vital signs, ecocolor-Doppler|For the healthy subjects (HC) of the group B, the Investigator has solely performed the medical history and a check of the vital signs, reporting the demographic and clinical data of the subjects. After completing the selection phase following the previous examinations, the subjects were directed towards the qualified practitioner for the ecocolor-Doppler examination which was performed in blind.
15838849|NCT04133766|Behavioral|Community Based Nutrition Package (CNBP)|The Community-Based Nutrition Package (CBNP) is a multi-level intervention that comprises: advocacy and training for government stakeholders and employees; selection and training of master trainers who then cascade the training at provincial level; and selection and training of community-level Nutrition Mobilizing Teams. The Nutrition Mobilizing Teams then organize a 2-day community mobilization session in the catchment areas of each health post to develop a community nutrition plan, which is then implemented by community health workers and two additional volunteers under the mentorship of the Nutrition Mobilizing Teams and with the support of the community members that participated in the community mobilization session.
15838850|NCT04133753|Behavioral|Facilitator-Based Intervention|Facilitators interact in person with patients, family, and clinicians both during and following the patient's ICU stay for 3 months. In-person contacts include visits to patients' homes and/or care facilities; phone contacts include calls to patients, families and clinicians. Patients and families have access to facilitators through phone and email. Facilitators may attend clinic visits with patients. In addition to checking directly with patients/families during regular contacts, facilitators also access the electronic health record to ensure they have accurate information about appointments and treatment plans and to document key points for the clinical team. Facilitators encourage referral to inpatient or outpatient palliative care services when needs are identified.
15838851|NCT04133740|Drug|Oxygen|Liberal versus conservative oxygen therapy.
15838852|NCT04133727|Behavioral|Use of an ageing suit|The simulation suit consists of a pair glasses which simulates narrowing of visual field; a pair of gloves ; a vest ; elbow and knee wraps and sand bags worn on the wrists and ankles
15838853|NCT04133727|Other|Polypharmacy workshop|Participants will conduct a full medication review for older adults within 1 hour and develop a medication list which can be used for counselling of older adults
15838854|NCT04133714|Device|multi-channel tDCS|multi-channel transcranial direct current stimulation, tDCS
15838855|NCT04133714|Device|single-channel tDCS|single-channel transcranial direct current stimulation
15838856|NCT04133701|Behavioral|Time-Restricted Feeding|After baseline measurements have been completed, participants will enroll in a time-restricted feeding intervention. Participants will be asked to restrict the time in which they eat each day to 10 hours, fasting for the remaining 14 hours. Participants will also be asked to finish their last meal of the day at least 2 hours prior to bedtime.
15838858|NCT04133675|Device|BTL Emsella|The Emsella Chair is a novel high-intensity focused electromagnetic (HIFEM) technology for the treatment of SUI, in addition to other pelvic floor related disorders. HIFEM technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercises over 28 minutes. The treatment paradigm consists of 3 different phases. The phases consist of an intense stimulation of the pelvic floor muscles (PFM), which consists of stimlulation and relaxation. The repetition of the phases and focused electromagnetic energy delivery leads to pelvic floor stimulation, adaptation, and remodelation.
15838895|NCT04133363|Procedure|Ridge preservation using L-PRF/FDBA|Atraumatic tooth extraction following by socket grafting using L-PRF/FDBA
15838896|NCT04133363|Procedure|Ridge preservation using L-PRF|Atraumatic tooth extraction following by socket grafting using L-PRF
15838859|NCT04133675|Device|Sham BTL Emsella|Sham subjects will be positioned on the device in the same manner as the active treatment group. The sham treatment will be provide some sensation without active HIFEM technology. The programming for the sham treatment will have an amplitude limitation, with the setting below therapeutic level (<10% power).
15838860|NCT04133662|Behavioral|Sleep Manipulation Protocol|A structured sleep duration intervention will be taught to patients
15838861|NCT04133649|Drug|AAV-hTERT|subjects will receive a single LGT (AAV-hTERT) treatment via IV administration
15838862|NCT04133636|Drug|JNJ-68284528|Participants in cohort A,B,C, D, E and F will receive JNJ-68284528 intravenously.
15838863|NCT04133636|Drug|Lenalidomide|Some participants in cohort D and all participants in cohort E will also receive lenalidomide capsules orally.
15838864|NCT04133636|Drug|Daratumumab|Participants in cohort E will also receive daratumumab subcutaneous (SC) injection.
15838865|NCT04133636|Drug|Bortezomib|Participants in cohort E will also receive bortezomib subcutaneously.
15838866|NCT04133636|Drug|Dexamethasone|Participants in cohort E will also receive dexamethasone orally or intravenously.
15838867|NCT04133623|Drug|Ketorolac|Administration of ketorolac 0.5 mg/kg up to 10 mg, one single dose at the enrollment. This group will receive also a placebo indistinguishable from the ibuprofen.
15838868|NCT04133623|Drug|Ibuprofen|Administration of ibuprofen 10 mg/kg up to 600 mg, one single dose at the enrollment. This group will receive also a placebo indistinguishable from the ketorolac.
15838869|NCT04133610|Diagnostic Test|Self-sampling using digene HC2 DNA Collection Device|All women will undergo a clinician-collected cervical swab and self-collected cervicovaginal swab.
15838870|NCT04133610|Diagnostic Test|Self-sampling using Evalyn Brush|All women will undergo a clinician-collected cervical swab and self-collected cervicovaginal swab.
15838871|NCT04133597|Device|social media stimuli (Line app)|social media stimuli (Line app) with texting messages or calls
15838872|NCT04133584|Biological|EV71 +SIV|Give 2 doses of EV71 +SIV, get 2 blood samples before the first dose and 28-43 days after the last dose.
15838873|NCT04133584|Biological|EV71|Give 2 doses of EV71 , get 2 blood samples before the first dose and 28-43 days after the last
15838874|NCT04133584|Biological|SIV|Give 2 doses of SIV , get 2 blood samples before the first dose and 28-43 days after the last
15838875|NCT04133571|Drug|0.05% Lidocaine|0.05% lidocaine with normal saline as a bladder irrigation solution after transurethral surgery intravenous pethidine to decrease CRBD if needed
15838876|NCT04133558|Other|tracheal aspirate during routine care|tracheal aspirate during routine care
15838877|NCT04133532|Drug|Metoprolol|metoprolol 50 mg daily for three months
15838878|NCT04133519|Device|Arm 1 - Active behavioral Treatment Arm (Regulora; Gut-Directed Hypnotherapy Software as a Medical Device - SaMD)|The active treatment consists of 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks (SaMD). Since subjects in both the active and comparator treatment arms receive a behavioral treatment, the subjects are blinded to active treatment.
15838879|NCT04133519|Device|Arm 2 - Active Comparator behavioral treatment arm (MR-1; Muscle Relaxation, Software as a Medical Device - SaMD)|The comparator treatment consists of an identical treatment platform, scheduling platform, and reminder platform as the Active Treatment Arm, but in place of Gut-Directed Hypnotherapy there is a comparator relaxation treatment administered on an identical schedule: 7 unique video/audio recordings administered via a mobile application every other week for 12 weeks.
15838880|NCT04133506|Drug|Aspirin 300mg|see earlier (only half of healthy volunteers receive aspirin)
15838881|NCT04133493|Device|Kerecis Omega3 Wound|"The intervention group will receive, in addition, a fish skin graft (KerecisTM Omega3 Wound) secured with Steristrips, sutures or staples, covered with a nonadherent dressing (Adaptic, Systagenix, Yorkshire, UK or equivalent), the product bolstered down to the wound bed with a foam dressing (HydraFoam, DermaRite) and hydrogel as needed to retain adequate moisture balance and padded with stretch gauze and self adherent wrap as needed.
~The wound will be dressed by the site investigator 1 day a week."
15838882|NCT04133493|Device|Fibracol|The Standard of Care Group will receive Fibracol covered with DSD. Change three times per week
15838883|NCT04133480|Drug|GWP42003-P|oral solution of 100 milligrams per milliliter (mg/mL) cannabidiol (CBD)
15838884|NCT04133467|Other|scalp block|intravenous acetaminophen according to the body weight, plus intravenous tramadol 1 mg/kg)
15838885|NCT04133454|Drug|AAV-hTERT|subjects will receive a single LGT (AAV-hTERT) treatment via IV and IT administration
15838886|NCT04133428|Drug|Sacubitril-Valsartan|"Evaluation of the Sacubitril-Valsartan treatment effectiveness.
~As there are three possible doses, during the first 30 days of treatment 3 evaluations will be carried out (every 10 days) for dose titration based on safety and tolerability as well as a blood test the 30rd day of treatment.
~Afterwards the patient will be evaluated after 3 and 6 months of treatment with a blood test and in the final visit (6 months) an echocardiography will be carried out and the final clinical evaluation will be made."
15838887|NCT04133415|Radiation|Lattice stereotactic body radiation therapy|-As long as radiotherapy fields do not overlap, treatment of up to 4 other tumor sites are allowed
15838888|NCT04133415|Procedure|Peripheral blood|-Before treatment, immediately after radiotherapy completion, 14 days after radiotherapy, and 30 days after radiotherapy
15838889|NCT04133389|Other|Growth mindset of personality educational intervention|This is a brief online educational intervention that teaches growth mindset of personality. The intervention includes pictures, text, videos, and questions administered through Qualtrics survey software.
15838890|NCT04133389|Other|Growth mindset of athletic ability educational intervention|This is a brief online educational intervention that teaches growth mindset of athletic ability. The intervention includes pictures, text, videos, and questions administered through Qualtrics survey software.
15838891|NCT04133376|Other|Electronic Hookah Inhalation (+ nicotine)|Participants will be instructed to inhale a typical 30-minute session of e-hookah containing nicotine
15838892|NCT04133376|Other|Electronic Hookah Inhalation (- nicotine)|Participants will be instructed to inhale a typical 30-minute session of e-hookah not containing nicotine
15838893|NCT04133376|Other|Sham Inhalation|Participants will be instructed to inhale a 30-minute sham session
15838894|NCT04133363|Procedure|Ridge preservation using L-PRF/FDBA layered technique|Atraumatic tooth extraction following by socket grafting using L-PRF/FDBA layered technique
15838897|NCT04133350|Behavioral|Active Patient Engagement|The APE intervention will be delivered through a patient-facing application and website called myAir, which provides patients with access to their own usage data, educational tips, and coaching.
15838898|NCT04133337|Drug|Apatinib|Apatinib Mesylate Tablets
15838899|NCT04133337|Drug|SHR-1210|Camrelizumab for Injection
15838900|NCT04133324|Diagnostic Test|C-reactive protein|C-reactive protein at postoperative days four and two.
15838901|NCT04133311|Drug|DE-130A|Latanoprost 50 microg/ml eye drops emulsion, eye drops emulsion in single-dose containers
15838902|NCT04133311|Drug|Xalatan®|Latanoprost 50 microg/ml eye drops solution, eye drops in 2.5 ml dropper containers
15838903|NCT04133298|Procedure|Tunneling with laser de-epithelized gingival graft|After the administration of local anesthesia, the dimension of the needed graft will be marked by a #15c blade and then diode laser de-epithelization will take place. The de-epithelized area will be then harvested using a # 15c blade. The donor site will be covered by cyanoacrylate tissue adhesive dressing .
15838904|NCT04133298|Procedure|Tunnelingwith subepithelial connective tissue graf|After administration of local anesthesia. A single incision will be made to the bone in a horizontal direction 3mm apical to the gingival margin of the maxillary teeth. The length of the incision will be determined by the dimensions of the graft required. A partial-thickness dissection will be then made within the single incision aiming to harvest an average thickness of two mm subepithelial connective tissue. Then, the graft will be carefully elevated from the palate with the use of the blade. Primary closure will be obtained using 4-0 polyglycolic acid
15838905|NCT04133259|Drug|Recombinant anti-programmed death-1 (PD-1) humanized monoclonal antibody|Treatment of CHB patient with HLX10
15838906|NCT04133259|Drug|Nucleoside/nucleotide analogues|Treatment NAs for chronic hepatitis B subject to achieve adequate HBV viral suppression
15838907|NCT04133246|Behavioral|Focus group|Groups of 6 to 10 patients and spouses led by the psychologist about their parenthood lasting 2 hours
15838908|NCT04133246|Behavioral|Individual interview|Interview led by the psychologist about the patient's parenthood
15838909|NCT04133233|Drug|ILT101|Treatment administration consists in a first course of five-day treatment (induction), followed by a single injection every week for 4 weeks (maintenance; from Week 3 to Week 6)
15838910|NCT04133233|Drug|Placebos|Treatment administration consists in a first course of five-day treatment (induction), followed by a single injection every week for 4 weeks (maintenance; from Week 3 to Week 6)
15838911|NCT04133194|Drug|Mesalazine|1600 mg Asacol [mesalazine]
15838912|NCT04133194|Drug|Mesalazine|800 mg Asacol [mesalazine]
15838913|NCT04133181|Device|3D guide|Use of a 3D guide in endodontic surgery
15838914|NCT04133181|Device|Mock guide|Use of a mock guide in endodontic surgery
15838915|NCT04133168|Device|POLARx™ Cardiac Cryoablation System|"The POLARx Cardiac Cryoablation System is intended for ablation and electrical mapping of the pulmonary veins for pulmonary vein isolation (PVI) in the ablation treatment of patients with paroxysmal atrial fibrillation (PAF).The system consists of the following devices and components:
~POLARx™ Cryoablation Catheter
~POLARMAP™ Catheter
~POLARSHEATH™
~SMARTFREEZE™ Console
~Diaphragm Movement Sensor (DMS)
~Related Accessories"
15838916|NCT04133155|Drug|nab paclitaxel plus gemcitabine|Nab-paclitaxel 125 mg/m2 weekly for 3 weeks, every 4 weeks Gemcitabine 1000 mg/m2 weekly for 3 weeks, every 4 weeks
15838917|NCT04133142|Procedure|peripheral nerve block, inter fascial nerve block|regional anaesthesia by Inter fascial block, peripheral nerve block. The type of block would be the most appropriate to cover the dermatomes involved in the Herpes according to the mapping done with the higher ratio benefit risks. The choice of the block will be done by an anesthesiologist expert in regional anaesthesia techniques. local anesthetic will be ropivacaine 0.5% posology according to the type of block
15838918|NCT04133129|Behavioral|Low Volume-High Intensity Interval Training|On a treadmill, a 2 minute warm-up will be followed by 2 bouts of 4 minutes at an intensity between 85% and 95% of Maximum Heart Rate (HRmax) interspersed by a 2 minutes recovery bout at 70% of heart rate max, followed by a 3 minutes Cool Down
15838919|NCT04133129|Behavioral|Moderate Intensity Continuous Training|On a treadmill,a 2-minute warm-up will be followed by 45 minutes at 65%-75% of Heart Rate max followed by 3 minutes cool down.
15838920|NCT04133116|Drug|LY3471851|Administered SC
15838921|NCT04133116|Drug|Placebo|Administered SC
15838922|NCT04133103|Procedure|first ambulation at 4 hour after operation|Two groups were conducted for first ambulation at 4 or 24 hours aftër operation
15838923|NCT04133090|Procedure|Autogenous block bone graft|Vertical and horizontal osteotomies were performed by means of a 6-mm diameter separation disc under copious irrigation with saline.The harvested bone graft was immediately placed in sterile saline solution to prevent dehydration. Sharp edges around the block graft were rounded under saline irrigation using a 4-mm round bur. The screw holes were properly made on both the recipient site and the block graft using a 1.3 mm drill. The graft was firmly fixed with 1.3 mm screws and a compatible driver. The periphery of the graft and the underlying gap between the screws and the recipient site, were covered with a mixture of particulate allograft and sterile saline solution to minimize resorption and to improve the adaption of the graft. All augmentation sites were covered by L-PRF membrane and flap closure was effected with 4/0 silk suture.
15838924|NCT04133090|Procedure|i-PRF enriched allograft material+ screw tent pole technique|The i-PRF preparation was performed as follows: the blood sample collected in an 8 ml, non-coated plastic tube without anticoagulant was immediately centrifuged at a protocol of 2700 rpm for 2 min. After centrifugation, the liquid autologous fibrin material which comprised the 1 mL upper layer of the tube was collected, using a disposable syringe. The screw holes were made on the recipient site using a 1.3 mm drill. 7 mm long screws were fixed 2mm or 4mm higher than on the recipient site to provide the desired augmentation distance and stabilized by a compatible driver. i-PRF was mixed with allograft material in a sterile metal box. Polymerization was done in 3 to 5 minutes, then this material was applied to the underlying gap between the screws and the recipient site.All augmentation sites were covered by L-PRF membrane and flap closure was effected with 4/0 silk suture.
15838925|NCT04133077|Biological|blood samples collection|Serology and genetic analyses will be performed in patients blood samples
15838926|NCT04133064|Device|Pivot Breath Sensor|The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.
15840083|NCT04123392|Drug|Decitabine|Decitabine was administered at 20mg/m2/day on days -14 and -10.
15838927|NCT04133051|Drug|Quadratus Lumborum Block Using Bupivacaine 0.2%|"Ultrasound guided transmuscular approach for quadratus lumborum block using an 18 gauge Touhy's epidural needle to insert the catheter. Normal saline 5 mL will be used to identify that plane. A volume of 20 ml of 0.25% of Bupivacaine bolus will be injected in that plane just over QL. This will be followed by epidural catheter insertion to facilitate continuous infusion. A similar procedure will be performed on the other side. A continuous infusion of 0.2% Bupivacaine at 5 ml/h will be administered to the patient.
~This transmuscular quadratus lumborum (TQL) block, has been suggested to be a simple and perhaps safer alternative to the anterior approach as was described for the original QL block"
15838928|NCT04133051|Drug|Epidural Analgesia Using Bupivacaine 0.25%|"With Patients placed in sitting position, puncture site will be identified at (T8-9, T9-10, or T10-11) intervertebral spaces. Using aseptic conditions, an 18G Tuohy epidural needle will be used to insert epidural catheter as appropriate.
~Induction of epidural analgesia with 10-15 ml bupivacaine 0.25% preoperatively with top up doses of 5-7 ml bupivacaine 0.25% or equivalent administered judiciously till we achieve analgesic level of T4 to L1. The calculated top up doses will be administered each hour using bupivacaine 0.25% or by using a continuous infusion syringe pump for equivalent doses"
15838929|NCT04133038|Other|Questionnaire|Parent(s) answering questionnaires about his child's phobic and selective eating behaviour.
15838930|NCT04133025|Other|Vestibular Rehabilitation|Vestibular Exercises and Software in vestibular rehabilitation
15838931|NCT04133012|Other|Samplings|"blood samples
~rectal biopsies
~nodes biopsies
~cutaneous fat tissues biopsies
~semen sample"
15838932|NCT04132999|Behavioral|Family-informed intervention|Multiple face-to-face visits, telephone calls and-person visits with the PAP psychologist and team
15838933|NCT04132999|Behavioral|Standard Clinical Care|Support which is given as part of the standard clinical care for patients who are currently prescribed PAP.
15838935|NCT04132960|Drug|DS-8201a|Anti-HER2-antibody drug conjugate (ADC)
15838936|NCT04132908|Dietary Supplement|Dietary Supplement: nutraceutical|Subjects will consume two capsules at breakfast and dinner for ten weeks.
15838937|NCT04132908|Dietary Supplement|Placebo|Subjects will consume two capsules at breakfast and dinner for ten weeks.
15838938|NCT04132895|Other|observational only, no interventions are prescribed in protocol.|"Treatment will be given as per usual standard of care.
~No treatments are specified by this protocol."
15838939|NCT04132882|Drug|Sodium Thiosulfate (STS)|
15838940|NCT04132869|Behavioral|Sports Readiness Intervention|Sixth graders will participate in a 6 month after-school program in which each daily session will last 90 minutes, 60 minutes of which will be moderate to vigorous physical activity. Two sports tracks will be offered during each 8-week season, and children will choose which they prefer. Coaches will be trained through a one day capacity building session and will receive online training throughout the program. Coaches will integrate sports readiness/physical activity programming, nutrition and healthy eating, and social emotional learning into the program with a focus on habit formation. A text-based platform will be utilized to encourage habits learned in the active portion of the program during June and July as well as on weekends during the intervention. Parents will be sent fliers weekly summarizing concepts addressed, and will be invited to cooking classes to watch students compete.
15838941|NCT04132856|Other|Psychosocial Navigator|Services of psychosocial navigator
15838942|NCT04132856|Other|Communication of Summary Profile|Both patient/caregiver dyad and HCPs will receive a summary of the PAT results and levels of depression and anxiety.
15838943|NCT04132843|Drug|Gadobenate Dimeglumine|Given IV
15838944|NCT04132843|Drug|Gadobutrol|Given IV
15838945|NCT04132843|Procedure|Magnetic Resonance Imaging|Undergo MRI
15838946|NCT04132817|Biological|Nivolumab|specified dose on specified days
15838947|NCT04132817|Biological|Ipilimumab|specified dose on specified days
15838948|NCT04132817|Drug|Nab-paclitaxel|specified dose on specified days
15838950|NCT04132791|Other|placebo after awakening + aspirin before bedtime|determine the difference in major adverse cardiovascular events between the group with aspirin after awakening and placebo before bedtime and the group with placebo after wakening and aspirin before bedtime.
15838951|NCT04132791|Other|aspirin after awakening + placebo before bedtime|determine the difference in major adverse cardiovascular events between the group with aspirin after awakening and placebo before bedtime and the group with placebo after wakening and aspirin before bedtime.
15838952|NCT04132778|Device|AsthmaTuner|Conventional treatment was defined as non-digital self-management using paper individual treatment plans, which contained treatment adjustments of prescribed medications according to symptoms of controlled, partly controlled or uncontrolled asthma, along with instructions according to national guidelines.
15838953|NCT04132765|Other|Drooling Impact Scale|A scale with 10 items which are scored with visual analog scale from1 to 10. Drooling impact increases with increased scores.
15838954|NCT04132765|Other|Drooling Frequency and Severity Scale|In this scale, parents or care givers were asked to rate the severity and frequency of drooling, classifying severity of drooling using a 5-level domain ranging from 1 (dry) to 5 (profuse drooling). The frequency of drooling was classified using a 4-level domain ranging from 1(no drooling) to 4 (constant drooling)
15838955|NCT04132765|Other|The Caregiver Priorities and Child Health Index of Life with Disabilities (CPCHILD™)|A quality of life scale that measure caregivers' perspectives on the health status, comfort, well being, and ease of caregiving of children with severe developmental disabilities. CPCHILD consists of 36 items distributed over six sections representing the following domains: (1) Personal Care (eight items); (2) Positioning, Transfer, and Mobility (eight items); (3) Communication and Social Interaction (seven items); (4) Comfort, Emotions, and Behaviour (nine items); (5) Health (three items); and (6) Overall Quality Of Life (one item). For the sections which involve the performance of skills, the degree of difficulty of accomplishing each task or activity was rated on a 7-point ordinal scale anchored by 0 ('No problem at all') to 6 ('Impossible').
15838987|NCT04132583|Drug|Deflox®|Participants received a single oral dose of 50 mg Deflox® tablet in either treatment period 1 or 2 under fasting conditions.
15838956|NCT04132765|Other|Drooling Quotient (DQ)|DQ is a semi-quantitative method that assesses the presence of newly formed saliva on the lips every 15 seconds with 40 observations in 10 minutes, expressed as a percentage based on the ratio between the number of observed drooling episodes and the total number of observations.
15838957|NCT04132765|Other|Patient and caregiver visual analog scale (VAS) for drooling|Patients will be asked to score their children's drooling severity on a visual analog scale (0-100 mm, 0 none to 100 severe)
15838958|NCT04132765|Other|Functional Oral Intake Scale (FOIS)|Functional Oral Intake Scale (FOIS) which is a 7-point ordinal scale document the functional level of oral intake of food and liquid.
15838959|NCT04132765|Other|number of bibs daily used|Parents will be asked their children's number of bibs daily used.
15838960|NCT04132765|Other|number of hospital admissions per year related to respiratory infections|Parents will be asked their children's number of hospital admissions per year related to respiratory infections.
15838961|NCT04132765|Other|Gross Motor Function Classification System (GMFCS)|The GMFCS describes self-initiated movement and use of assistive devices (walkers, crutches, canes, wheelchairs) for mobility during an individual's usual activity.
15838962|NCT04132765|Other|Manual Ability Classification System (MACS)|The MACS is also a simple, five-point ordinal classification system and was designed for use in children ages 4-18 years. The MACS is a validated measure in cerebral palsy that can be used to classify a child's typical use of both hands and upper limbs.
15838963|NCT04132765|Other|Communication Function Classification System (CFCS)|The CFCS is a simple, five-point ordinal classification system that assesses everyday communication (not optimal communication) of children with cerebral palsy.
15838964|NCT04132765|Other|Eating and Drinking Ability Classification System (EDACS)|EDACS is a measure to assess eating and drinking ability for children with CP, ages 3 and older. This classification is a simple five-point ordinal system.
15838965|NCT04132752|Other|Motivation|Families were called via phone weekly and all questions were answered. Parents were motivated through phone.
15838966|NCT04132739|Behavioral|Diet|The Nutrition Intervention will consider the participants' food preferences and concerns for managing glycemic control and maintaining muscle-mass. Each topic will be presented interactively and the participants will be encouraged to attend 2 times/week (attendance will be logged). The topics will be presented as a combination of evidenced-based materials for older adults with type 2 diabetes. We anticipate 3 sessions/topic during the 6-month intervention and will modify the topics and time to fit the needs of our audience. The lessons and materials will be offered in English and Spanish. The food quality change will be measured using a Food Frequency Questionnaire validated in Hispanic populations. The goals are to increase the participants' self-efficacy (belief and self-confidence) that they have the tools necessary to manage diabetes and reduce mobility impairments.
15838967|NCT04132739|Behavioral|Exercise|The Exercise Intervention will involve 30-minute exercise sessions based on the Otago Exercise Program. The exercises involve lower and upper limb strengthening, balance training and a walking plan. The participants will receive illustrations of the exercises to do. Each participant will exercise for 30 minutes, 2x/week during supervised sessions in the facilities and be encouraged to do the exercises by themselves on days the group sessions are not offered. We will also teach self-monitoring for signs of low-blood glucose to ensure safety. Progression will be done every two weeks during the first 2 months, once at month 3, and once at month 6 by increasing intensity and/or difficulty and the walks by increasing continuous walking time and walking speed without compromising safety.
15838968|NCT04132739|Behavioral|Diet and exercise|A combination of the diet and exercise interventions following the same procedures previously described.
15838969|NCT04132726|Other|Massage therapy|Massage therapy performed by a physiotherapist
15838970|NCT04132726|Other|non-effective treatment|non-effective treatment
15838971|NCT04132713|Drug|Capecitabine 150Mg Oral Tablet|Advanced breast cancer patients with first-line medication
15838972|NCT04132700|Device|Q-NRG Metobolic Cart Device|ICU pateints will be measured using the Q-NRG device for up to 30 mins. These measurements will take place every other day while the patients are in the ICU. Then they will occur a minimum of 3 times a week until discharge.
15838973|NCT04132687|Procedure|autologous blood patch therapy|use autologous blood as blood patch therapy in persistent air leak
15838974|NCT04132674|Drug|Bictegravir/emtricitabine/tenofovir alafenamide|Taking one oral tablet of B/F/TAF once-daily for 72 weeks
15838975|NCT04132661|Drug|Bisacodyl 5 milligram|one single dose
15838976|NCT04132661|Drug|Placebo oral tablet|one single dose
15838977|NCT04132648|Drug|Curcumin|Oral supplement one time at 2,000 mg
15838978|NCT04132648|Other|Placebo|Oral supplement one time at 2,000 mg
15838979|NCT04132635|Device|artificial dermis|artificial dermis will be used after fully debridement of the wound
15838980|NCT04132635|Other|growth factor|growth factor
15838981|NCT04132622|Drug|Levothyroxine Sodium|Levothyroxine Sodium Tablets (50 ug, calculated by Levothyroxine Sodium ), produced by Merck KGaA, Darmstadt.
15838982|NCT04132622|Drug|Traditional therapy|including steroids, vitamin C, hemodialysis and blood perfusion.
15838983|NCT04132609|Behavioral|Cognitive bias modification|: In CBM, the task presentation and timing is the same as attentional bias, except the probe always replaces the neutral word. It ensures that: 1) the duration of CBM and control training should not differ; 2) CBM and control participants receive equal practice on the motoric aspects of the task; and 3) CBM and control participants are exposed to the same word cues. Based on previous data, duration of CBM and control trainings will be about 10 minutes.
15838984|NCT04132609|Behavioral|Standard attentional bias|"the standard attentional bias task, a drug or pain-related word is presented next to a neutral word for 500ms. Subsequently, a probe (i.e., a q or p) replaces the drug/pain word or the neutral word at an equal rate. The participant's task is to indicate the location of the probe as quickly as possible by pressing q or p. Attentional bias is calculated from the difference in reaction times (i.e., neutral cue minus drug/pain cue) to indicate the location of the probe, with higher values indicating greater attentional bias. For all tasks, opioid and pain words will be presented in separate blocks in counterbalanced order. Neutral words paired with opioid or pain words will be matched for length and frequency of use in the English language."
15838985|NCT04132596|Device|Transcutaneous spinal cord stimulation|Electrical stimulation of the spinal cord via transcutaneous hydrogel electrodes
15838986|NCT04132596|Other|Activity Based Therapy|Physical therapy
15838988|NCT04132583|Drug|Cataflam DD®|Participants received a single oral dose of 50 mg Cataflam DD® tablet in either treatment period 1 or 2 under fasting conditions.
15838989|NCT04132570|Drug|Budesonide|Participants will self-administer 2 nasal sprays of Budesonide (64 mcg/spray) once daily up to 10 +\- 3 Days.
15838990|NCT04132570|Other|Placebo|Participants will self-administer 2 nasal sprays of matching placebo once daily up to 10 +\- 3 Days.
15838991|NCT04132557|Drug|Methylphenidate|Methylphenidate is common ADHD medications in the United States. This is a non-interventional study and no drug will be given as part of this study. Analysis will be performed from data taken from three United States (US) health care databases and one US electronic health record database.
15838992|NCT04132557|Drug|Lisdexamfetamine|Lisdexamfetamine is common ADHD medications in the United States. This is a non-interventional study and no drug will be given as part of this study. Analysis will be performed from data taken from three US health care databases and one US electronic health record database.
15838993|NCT04132557|Drug|Atomoxetine|Atomoxetine is common ADHD medications in the United States. This is a non-interventional study and no drug will be given as part of this study. Analysis will be performed from data taken from on three US health care databases and one US electronic health record database.
15838994|NCT04132557|Drug|Amphetamine|Amphetamine is common ADHD medications in the United States. This is a non-interventional study and no drug will be given as part of this study. Analysis will be performed from data taken from on three US health care databases and one US electronic health record database.
15838995|NCT04132557|Drug|Dextroamphetamine|Dextroamphetamine is common ADHD medications in the United States. This is a non-interventional study and no drug will be given as part of this study. Analysis will be performed from data taken from on three US health care databases and one US electronic health record database.
15838996|NCT04132544|Other|standardized gerontological evaluation (EGS)|Evaluation (EGS): initially, the patient benefits from a complete EGS and a complete fall balance realized by an IDEG (initial visit V0) in the 7 working days following the intervention of the SAMU for fall. This assessment is based on the EGS (Rubenstein LZ, 1984) and the assessment of risk factors for falls (HAS, INPES).
15838997|NCT04132544|Other|Proposal for a personalized intervention plan (PIP)|"A PIP containing personalized recommendations to improve the patient's state of health, treatment and environment as well as risk factors for falls is proposed during the multi-professional consultation and discussed by telephone with the attending physician (pre-arranged telephone appointment). with the latter).
~The PIP validated by the attending physician is delivered and explained to the patient by the IDEG in the week following the CPR during the V1 visit to the patient's home."
15838998|NCT04132544|Other|Follow-up|"Four follow-up visits at 6, 12, 18 and 24 months (V2, V3, V4, V5) are performed at the patient's home. During these visits, the IDEG reassesses the person from the gerontological point of view and from the point of view of risk factors for falls.
~A mail containing the elements of interest is sent to the attending physician after each visit. The patient is also contacted by telephone by the IDEG at 2, 4, 9, 15 and 21 months of follow-up to maintain a link, identify possible difficulties and encourage him / her to apply the PIP recommendations."
15838999|NCT04132544|Other|Usual care|"The patients included in the control group will benefit from the usual care as well as documentation on general recommendations to be put in place to prevent falls and to age in good health [series of brochures published by INPES for the elderly. They are informed by telephone of their home group by the IDEG. The documents are sent by mail to the patient's home address."
15839000|NCT04132531|Procedure|Bariatric (weight loss) surgery|Surgical intervention for weight reduction, whereby the stomach is resected and the gastrointestinal tract is rerouted in the case of Roux-en-y gastric bypass, or the stomach is only resected in the case of sleeve gastrectomy.
15839001|NCT04132518|Device|Sculptra|Initial injection and optional 3 injections with Sculptra in Midface.
15839002|NCT04132505|Drug|Binimetinib|Given PO
15839003|NCT04132505|Drug|Hydroxychloroquine|Given PO
15839004|NCT04132479|Drug|Clarithromycin 500mg|1000mg taken orally every 12 hours for 5 days
15839005|NCT04132479|Drug|Amoxicillin 500mg|1000mg taken orally every 12 hours for 5 days
15839006|NCT04132479|Drug|Tinidazole 500mg|500mg taken orally every 12 hours for 5 days
15839007|NCT04132479|Drug|Rabeprazole 20mg|20mg taken orally every 12 hours for 5 days
15839008|NCT04132479|Drug|Clarithromycin 500mg|1000mg taken orally every 12 hours for 14 days
15839009|NCT04132479|Drug|Amoxicillin 500mg|1000mg taken orally every 12 hours for 14 days
15839010|NCT04132479|Drug|Tinidazole 500mg|500mg taken orally every 12 hours for 14 days
15839011|NCT04132479|Drug|Rabeprazole 20mg|20mg taken orally every 12 hours for 14 days
15839012|NCT04132466|Device|Defibrillation using the ASSURE wearable cardioverter defibrillator therapy delivered via a waveform delivery test system|defibrillation using a 170 joule biphasic truncated exponential waveform designed for the ASSURE wearable cardioverter defibrillator
15839013|NCT04132453|Device|Arterial catheterization kit|Invasive monitoring of blood pressure via catheterization of the radial artery, displaying a continuous pressure waveform
15839014|NCT04132453|Device|GE Datex-Ohmeda Finger Clip Pulse Oximeter Sensor|PPG based, fingertip mounted sensor, that measures the oxygen level (oxygen saturation) of the blood and generates a waveform
15839015|NCT04132453|Device|NIBP Cuff (GE Healthcare)|A blood pressure cuff is used to measure blood pressure. The cuff has an inflatable rubber bladder that is typically fastened around the arm. A pressure meter indicates the cuff's pressure.
15839016|NCT04132440|Other|Interview|Complete interview
15839017|NCT04132440|Other|Questionnaire Administration|Complete questionnaire
15839018|NCT04132427|Combination Product|vancomycin, magnesium citrate, microbiota|10 days of oral vancomycin, then 1 day of oral magnesium citrate, , then 4 days of high-dose oral microbiota, followed by 12 weeks of low-dose oral microbiota
15839019|NCT04132427|Combination Product|placebo vancomycin, real magnsium citrate, placebo microbiota|10 days of oral placebo vancomycin, then 1 day of oral real magnesium citrate, , then 4 days of high-dose oral placebo microbiota, followed by 12 weeks of low-dose oral placebo microbiota
15839020|NCT04132414|Diagnostic Test|NIRS open|Treatment according to protocol in phases of cerebral hypoxia.
15839080|NCT04131907|Device|Optilume Sham Device|21 Fr sheathed Optilume™ BPH Prostatic Pre-dilation Catheter (modified to prevent inflation)
15839081|NCT04131894|Biological|autogenous dentin graft|
15839021|NCT04132401|Diagnostic Test|algorithm|The diagnostic capacity of the algorithm will be compared with that of the family medicine physicians and with retina specialists. The reference will be a blinded double reading conducted by the retina specialists
15839022|NCT04132388|Other|Electronic Reporting|"The electronic reporting intervention consists of reporting the experience with the treatment (whether the treatment was taken, the efficacy of the treatment, and any issues that have come up) at weekly intervals for 6 weeks, then every 4 weeks thereafter.
~Subjects will return for evaluation at 12 & 26 weeks (or end of study). At each visit the subject will be scored for disease severity and adverse events. The assessor of these measures will be blinded to treatment group assignment. At the baseline and at the end of therapy visit (26 weeks), all subjects will complete a HS self-assessment questionnaire, treatment satisfaction questionnaire and physician trust survey. Pregnancy tests will be completed on females of childbearing potential at the baseline visit."
15839023|NCT04132388|Drug|Adalimumab|Subjects will be instructed to take Humira according to the labelled dosing regimen. Treatment will be for 26 weeks
15839024|NCT04132375|Drug|INM004|"The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. Each vial contains 25 mg protein/mL. Therefore, each subject must receive 0.16 mL/kg.
~The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 24 h between doses."
15839025|NCT04132375|Drug|Placebo|"The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. Each vial contains 25 mg protein/mL. Therefore, each subject must receive 0.16 mL/kg.
~The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 24 h between doses."
15839026|NCT04132362|Behavioral|Personalised music listening|People will be sequentially recruited to discover their favourite music playlist, monitor their emotional responses to specific songs and explore the impact of listening to the music, on their behavioural and psychological symptoms. This will be done through a one hour music listening session, to discover the top 10-20 songs they respond to. It will then be followed by multiple shorter music listening sessions, initiated by the dementia resident themselves or their carer, where they listen to their favourite songs during their day, before difficult moments of care or during visits with their families.
15839027|NCT04132362|Behavioral|Using fMRI to investigate the effect of listening to personalised music evoking positive emotional response on brain activation|12 of the recruited participants, who have symptoms and signs of mild to moderate dementia will be invited to take part in this sub-study. Using an amended version of a previously employed fMRI paradigm, each study participant will be presented inside the MRI scanner with short 30 second epochs of music (identified as evoking a positive or neutral emotional response) in a block design. Each 30 second epoch of music will be followed by a 16 second period when participants will be asked to rate subjective changes in their affective state using a computerised visual analogue scale. Epochs of positive emotional stimuli will alternate with epochs of neutral emotional stimuli in a counterbalanced order of presentation in 2 runs of 10 epochs each (5 positive and 5 neutral in each run).
15839028|NCT04132349|Drug|Ulipristal Acetate 5 mg|Ulipristal acetate (from Cenexi manufacturer, France) at daily dose of 5mg in 3 consecutive months course
15839029|NCT04132336|Drug|Naproxen sodium/Caffeine (BAY2880376)|Tablet, oral, single dose
15839030|NCT04132336|Drug|Naproxen sodium (Aleve)|Tablet, oral, single dose
15839031|NCT04132336|Drug|Caffeine|Tablet, oral, single dose
15839032|NCT04132336|Drug|Placebo|Tablet, oral, single dose
15839033|NCT04132323|Procedure|Sclerotherapy|Examination, photographing, inclusion in the study, signing of informed consent, randomization, diameter measurement, sclerotherapy according to the randomization group
15839034|NCT04132310|Other|N/A This is an observational study.|This is an observational study.
15839035|NCT04132297|Behavioral|Asthma Academy|The Asthma Academy is a one hour virtual training that includes providing information about asthma, asthma medications, communicating with healthcare providers and navigating healthcare resources.
15839036|NCT04132297|Behavioral|Telehealth Visit|The telehealth Visit will be conduct by a trained Doctor of Nurse Practice (DNP) student via a scheduled meeting through zoom on the participant's smart phone or computer. The visit will last about one hour wherein participant will be asked about their asthma knowledge and will be given information about asthma.
15839037|NCT04132284|Behavioral|DBT-Based Parenting Intervention|The intervention will consist of 8-10 individual parent sessions, to be completed within one week after the teen completes the IOP program. Sessions will be 1 hour in length and will be offered weekly. Therapists may see parents more than once a week if needed, as long as the total number of sessions does not exceed 10. Sessions will follow the standard agenda used for DBT skills training: 1) mindfulness practice, 2) homework review, 3) teaching of a new skill; 4) practice of the new skill; and 5) assignment of new homework (Linehan, 1993). The intervention will utilize the Middle Path module of the DBT Skills Manual for Adolescents (Rathus & Miller, 2015), which was created by the developers of DBT for adolescents and includes both instructions for therapists and handouts for clients.
15839038|NCT04132284|Behavioral|Treatment as Usual|No parenting intervention provided beyond standard practices in DBT IOP program.
15839039|NCT04132271|Other|Personalized diet|Modified texture and volumen diet according to the OD specifications
15839040|NCT04132271|Other|Control|Nutritional Recommendations according to the OD specifications
15839041|NCT04132258|Other|survey|(presence of certain antecedents, weight, height, current or past existence of inflammatory rhinitis) and a second by the specialist doctor (pathology at the origin of the start of biotherapy, year of beginning of treatment, previous biotherapies over the last 3 years).
15839042|NCT04132245|Behavioral|behavioral intervention|Families were randomized to a 14-week family based obesity prevention intervention or a 14-week general health intervention
15839043|NCT04132245|Behavioral|Obesity prevention intervention trial|Families were randomized to a 14-week obesity prevention intervention or a 14-week general health intervention
15839044|NCT04132232|Diagnostic Test|knowledge of expired maternal carbon monoxide and fetal carboxyhemoglobin levels|Will use the Smokerlyzer® device at each visit and be provided information on exhaled carbon monoxide and fetal carboxyhemoglobin. Risks of adverse perinatal outcomes related to maternal carbon monoxide and fetal carboxyhemoglobin level will be provided.
15839082|NCT04131894|Biological|platelet rich fibrin (PRF)|
15839083|NCT04131868|Behavioral|Typical sleep opportunity|Typical sleep opportunity with consistent sleep timing for 1 week
15839045|NCT04132219|Behavioral|eHealth Intervention|Every week, each dyad member will receive a tailored text message that provides a new fun fact or that encourages them to log-on to the website to access findings of new research and how the results might apply to them. They will be directed to specific pages in the Web-based program and asked to select strategies from a list that they will practice during the upcoming week. Graphic displays of their progress will be provided along with SCT-based feedback. They will be directed to the website to record their behavioral goals for the upcoming week. Tips also will be provided for effective communication to enhance couple efficacy. All usage will be tracked to assess adherence.
15839046|NCT04132206|Other|stool sampling|Participants will provide two stool samples: one collected the day of inclusion and a second, six months later
15839047|NCT04132180|Other|Early Mobilization|Range of motion exercises of the upper extremity will be performed under the guidance of the physical therapy team starting on post-operative day 1.
15839048|NCT04132180|Other|Late Mobilization|The patient's grafted upper extremity will be immobilized using an elbow flexion blocking splint until post-operative day 5.
15839049|NCT04132167|Procedure|perturbation training|exercises for body stability in different positions (bridge, sitting, quadrupedal, half- kneeling, kneeling, standing, monopodalic) performed with visual biofeedback; transfers training performed in front of a mirror; ambulation training with courses drawn on the ground in a straight line and with more complex tracks with visual controlin particular using the protocols seated balance/strength training, standing bal- ance/weight-bearing training, mobility training and closed-chain training;
15839050|NCT04132154|Procedure|Convective Forced-Air Active Warming|Underbody Blanket Model 585 of the 3M BairHugger Series
15839051|NCT04132141|Other|Virtual Reality Headset with curated content|clinicians will wear VR immersive headset for up to 15 minutes during their break
15839052|NCT04132128|Other|carbohydrate counting|taught how to count carbohydrates in their diet with their personal tool
15839053|NCT04132115|Drug|Piperacillin/tazobactam|Therapeutic drug monitoring (TDM) of this antibiotic plasma concentration
15839054|NCT04132115|Drug|Meropenem|Therapeutic drug monitoring (TDM) of this antibiotic plasma concentration
15839055|NCT04132115|Drug|Daptomycin|Therapeutic drug monitoring (TDM) of this antibiotic plasma concentration
15839056|NCT04132115|Drug|Ceftobiprole|Therapeutic drug monitoring (TDM) of this antibiotic plasma concentration
15839057|NCT04132115|Drug|Linezolid|Therapeutic drug monitoring (TDM) of this antibiotic plasma concentration
15839058|NCT04132115|Drug|Vancomycin|Therapeutic drug monitoring(TDM) of this antibiotic plasma concentration
15839059|NCT04132115|Drug|Fluconazol|Therapeutic drug monitoring (TDM) of this antifungal plasma concentration
15839060|NCT04132115|Drug|Acyclovir|Therapeutic drug monitoring (TDM) of this antiviral plasma concentration
15839061|NCT04132115|Drug|Gentamicins|Therapeutic drug monitoring (TDM) of this antibiotic plasma concentration
15839062|NCT04132115|Drug|Amikacin|Therapeutic drug monitoring (TDM) of this antibiotic plasma concentration
15839063|NCT04132115|Drug|Ganciclovir|Therapeutic drug monitoring (TDM) of this antiviral plasma concentration
15839064|NCT04132102|Drug|Afatinib|Afatinib is a member of the second generation TKIs, which binds irreversibly to the erbB family of receptors. Afatinib will be administrated orally with the starting dose of 40 mg tablets, once per day. If patients can't tolerate drug related AEs with 40mg, patients can receive 30mg once per day after AEs recovered to Grade 0-1.
15839065|NCT04132089|Behavioral|capABILITY|All participants utilized the designed capABILITy application. The application consisted of education material and persuasive messaging. There were two types of messaging components named facilitators and sparks. This created three groups consisting of: control, facilitators and sparks. Participants spent 1 month in each group (total duration of the study was three months).
15839066|NCT04132063|Drug|Generic levetiracetam|Generic levetiracetam tablet as the same dose as original levetiracetam tablet at the switching date
15839067|NCT04132050|Drug|R788|Oral administration
15839068|NCT04132050|Drug|Placebo|Oral administration
15839069|NCT04132037|Other|data record|At each protocol's visit, clinical and urinary data will be recorded and the answers of the questionnaires will be also reported
15839070|NCT04132024|Behavioral|Cognitive Behavioral Therapy for Insomnia (CBT-I)|CBT-I has a specific protocol with behavioral targets that differ significantly from standard CBT. This approach focuses on implementing sleep restriction and stimulus control interventions which are fully deployed during the first session. 5 CBT-I sessions will be delivered over the course of 8 weeks. Key recommendations include: 1) reduce time in bed; 2) get up at the same time every day; 3) do not go to bed unless sleepy; 4) do not stay in bed awake for more than 15 minutes; and 5) avoid napping. Participants are also taught relaxation strategies and cognitive therapy addresses arousal and catastrophizing.
15839071|NCT04132011|Drug|Extended Release Opioid Formulation, Shortened Intervals|Extended release opioid, individualized total daily dose, dosing interval is less than every 12 hours
15839072|NCT04132011|Drug|Extended Release Opioid Formulation, Standard intervals|Extended release opioid, individualized total daily dose, dosing interval is every 12 hours
15839073|NCT04132011|Drug|Placebo oral tablet|Lactose pill manufactured to mimic extended release opioid formulation
15839074|NCT04131985|Procedure|Erector Spina Block|After the C7 spinous protrusion is prepared as sterile as T10, the erector spina muscle is seen at the T7 level on the same side as the hernia with the convex probe and block is applied with 0.25% bupivacaine (20 cc).
15839075|NCT04131972|Device|REGENERA|REGENERA breast implant
15839076|NCT04131959|Device|CytoSorb 300 mL device|Intra-operative CytoSorb hemoadsorption of ticagrelor during cardiopulmonary bypass
15839077|NCT04131946|Other|Community-Based (Intervention Arm)|Community dispensed FIT
15839078|NCT04131920|Device|handheld ultrasound: Philips Lumify integrated tele-ultrasound powered by Reacts collaborative platform|Patients receive training by the physical therapist to operate a handheld ultrasound (HHUS) including proper probe placement. Subjects will be tested on their knowledge at the HTC to demonstrate proficiency, and will then repeat the testing at home via tele-ultrasound.
15839079|NCT04131907|Device|Optilume BPH Catheter System|The Optilume™ BPH, Prostatic Dilation DCB Catheter is a dilation catheter used to exert radial force to dilate the prostatic urethra resulting in a commissurotomy. The distal end of the catheter has a semi-compliant inflatable double lobe balloon that is coated with a proprietary coating containing the active pharmaceutical paclitaxel.
15839084|NCT04131868|Behavioral|Extended sleep opportunity|Extended sleep opportunity by 90 min per night with consistent sleep timing for 1 week
15839085|NCT04131855|Other|Pumice prophylaxis|Pumicing the teeth is the recommended prophylaxis to be used prior to the application of the self etch primer by the manufacturer - 3M Unitek Transbond Plus Self Etch Primer which will be used in the experiment.
15839086|NCT04131855|Other|No pumice prophylaxis|Pumice prophylaxis will not be used as per manufacturers instructions.
15839087|NCT04131842|Other|External focus of attention visual feedback|Patients will receive external focus of attention visual feedback during the impairment-based rehabilitation program.
15839088|NCT04131842|Other|External focus of attention auditory feedback|Patients will receive external focus of attention auditory feedback during the impairment-based rehabilitation program.
15839089|NCT04131842|Other|Internal focus of attention video feedback|Patients will receive internal focus of attention visual feedback during the impairment-based rehabilitation program.
15839090|NCT04131842|Other|No feedback|Patients will receive no feedback during the impairment-based rehabilitation program.
15839091|NCT04131829|Drug|Fluoxetine - immediate treatment|Following the Baseline assessment, OCD subjects will be randomized to receive either immediate fluoxetine monotherapy or delayed fluoxetine, after a 6-week placebo lead-in.
15839092|NCT04131829|Drug|Fluoxetine - delayed treatment|Following the Baseline assessment, OCD subjects will be randomized to receive either immediate fluoxetine monotherapy or delayed fluoxetine, after a 6-week placebo lead-in.
15839093|NCT04131816|Behavioral|HeartHome|The HeartHome program is an expanded home-based cardiac rehabilitation program that combines nurse home visits with telephone and electronic supports for participants that allows them to engage in cardiac rehabilitation activities at home.
15839094|NCT04131803|Drug|Bifico combined with chemotherapy plus targeted therapy|Bifico combined with chemotherapy plus targeted therapy
15839095|NCT04131803|Drug|chemotherapy plus targeted therapy|chemotherapy plus targeted therapy
15839096|NCT04131790|Behavioral|Tele-Behavioral Activation|Five 1-hour sessions of BA delivered by a trained interventionist via video-conferencing
15839097|NCT04131790|Behavioral|Tele-Friendly Visiting|Five 1-hour FV sessions delivered by a trained interventionist via video-conferencing
15839098|NCT04131777|Device|Radiofrequency (RF) catheter|A catheter introduced into the lung lesion via a bronchoscope, used to deliver radiofrequency (RF) energy for the purpose of ablation
15839099|NCT04131764|Diagnostic Test|Reflex (Brightlamp Inc., Purdue University)|The Reflex pupillometer is a mobile based application that provides a quantitative way to monitor pupillary activity and responsiveness. It uses the mobile phone as a source of light and records pupillary response, as well as analyzes and compiles the data. It produces quantitative measures such as latency, minimum and maximum pupil diameter, maximum and average constriction velocity, dilation velocity, and 75% recovery time.
15839100|NCT04131751|Diagnostic Test|Next generation sequencing|we will investigate the sensitivity and specificity of next generation sequencing as a diagnostic tool in ascites infections.
15839101|NCT04131738|Drug|Baricitinib|Baricitinib may be taken without regard to food. It should be taken at the same time every day.
15839102|NCT04131725|Device|Cardiac Performance System (NSR)|Device: Cardiac Performance System Participants will be asked to wear the Cardiac Performance System, a non-invasive sensor device on their upper abdomen. The Cardiac Performance System monitoring device will continuously monitor cardiac function. The device will be worn at the time when Pulmonary Artery Catheter procedures are conducted.
15839103|NCT04131712|Other|Massage|A custom-made cyclic compressive loading (CCL) device will be used to apply a mechanical load to the left thigh of the participants. Massage application using a 35 Newton load will be applied for 15 minutes every other day over the course of 7 days for a total of four massages.
15839104|NCT04131699|Device|Cardiotronic ICON continuous non-invasive cardiac output monitor.|cardiac index, cardiac output & stroke volume measured and recorded with every change in intrathoracic pressure.
15839105|NCT04131660|Device|AVAPS-AE mode during NIV|NIV will be setup in AVAPS-AE mode, with a Trilogy ventilation device (Respironics, Murrysville, PA). The range of positive expiratory pressure will be set between 4 and 14 cmH2O. The range of inspiratory pressure support will be set between 14 and 24 cmH2. The target tidal volume will be set to achieve 8 to 10 mL/kg of ideal body weight (Size (m) * Size (m) * 23).
15839106|NCT04131660|Device|S/T mode during NIV|"NIV will be setup in ST mode, with a Trilogy ventilation device (Respironics, Murrysville, PA).
~The physician will decide the level of positive expiratory pressure and of pressure support."
15839107|NCT04131647|Other|Weight Maintenance|Following a 12-week weight loss and exercise program, subjects will participate in a weight maintenance program of Heart Healthy nutrition, walking, and resistance band exercise
15839108|NCT04131647|Other|Weight Maintenance + Intermittent Fasting|Following a 12-week weight loss and exercise program, subjects will participate in a weight maintenance program of Heart Healthy nutrition, walking, resistance band exercise and intermittent fasting (2 small meals per day) one day per week for 24 weeks.
15839109|NCT04131634|Radiation|Stereotactic Ablative Radiation|A stereotactic relocalization system that relies upon stereoscopic radiographs, implanted fiducials, or near real-time CT based verification will be used.Investigators will have the discretion to choose from biologically equivalent dose levels using 1, 3 or 5 fractions. All active lesions need to be addressed by local therapy
15839110|NCT04131621|Biological|Nivolumab/Ipilimumab|Immune checkpoint inhibitor combination
15839111|NCT04131608|Diagnostic Test|CBC ,Serum ferritin ,HBA1C|Diabetic patients will be applied to CBC, HBA1C and serum ferritin
15839112|NCT04131595|Biological|MVA-BN-WEV Dose 1|1 x 10^7 Inf.U MVA-BN-WEV vaccine
15839113|NCT04131595|Biological|MVA-BN-WEV Dose 2|1 x 10^8 Inf.U MVA-BN-WEV vaccine
15839114|NCT04131595|Biological|MVA-BN-WEV Dose 3|2 x 10^8 Inf.U MVA-BN-WEV vaccine.
15839115|NCT04131582|Combination Product|Linagliptin + metformin and Empagliflozin + metformin|Linagliptin-Metformin 2.5/850mg once daily, Empagliflozin-Metformin 12.5/850mg one daily plus a lifestyle modification program based on nutritional assesment, physical activity prescription and general counseling
15839116|NCT04131582|Drug|Metformin|Metformin 850mg twice daily plus a lifestyle modification program based on nutritional assesment, physical activity prescription and general counseling
15839117|NCT04131569|Diagnostic Test|ESBL-E fecal carriage screening according to routine care|ESBL-E fecal carriage screening according to routine care
15839118|NCT04131556|Drug|Maribavir|Participants in both part 1 and part 2 of the study will receive maribavir tablet or suspension orally depending upon the treatment sequence allocation for a total of 7 and 10 days respectively.
15839119|NCT04131543|Drug|Cabozantinib 20 MG|Cabozantinib will be administered orally at a (starting) dose of 60 mg once daily. The drug is taken continuously over a period of 28 days (4 weeks), which constitutes one treatment cycle. In all subjects, dose reductions (40mg 20mg) and delays to manage toxicity.
15839120|NCT04131543|Drug|Cabozantinib 40 MG|Cabozantinib will be administered orally at a (starting) dose of 60 mg once daily. The drug is taken continuously over a period of 28 days (4 weeks), which constitutes one treatment cycle. In all subjects, dose reductions (40mg 20mg) and delays to manage toxicity.
15839121|NCT04131543|Drug|Cabozantinib 60 MG|Cabozantinib will be administered orally at a (starting) dose of 60 mg once daily. The drug is taken continuously over a period of 28 days (4 weeks), which constitutes one treatment cycle. In all subjects, dose reductions and delays to manage toxicity. Cabozantinib should be taken in fasting condition with no food for at least 2 hours before and 1 hour after taking the tablets. A high fat meal significantly increased the median tmax to 6 hours from 4 hours (fasted). The treatment will be continued until disease progression, intolerable toxicity, patient refusal or Investigator's decision or any criterion for withdrawal from the trial or trial drug is fulfilled.
15839122|NCT04131530|Diagnostic Test|The diagnosis of Artificial Intelligence and endoscopist|When the colon mucosa is observed using pCLE, endoscopist and AI will make a diagnosis independently. In addition, the endoscopist can not see the diagnosis of AI.
15839123|NCT04131517|Drug|Padsevonil|Study Medication: Padsevonil Dosage formulation: Oral tablets; 400 mg BID (Part 1) and 200 mg BID (Part 2)
15839124|NCT04131517|Drug|Microgynon 30®|Study Medication: Microgynon 30® Dosage formulation: Oral tablets Dose: Ethinyl estradiol 30 µg + levonorgestrel 150 µg
15839125|NCT04131504|Drug|Infliximab|No standard dosing regimen will be used and the dose will be determined by the treating physician
15839126|NCT04131504|Drug|Adalimumab|No standard dosing regimen will be used and the dose will be determined by the treating physician
15839127|NCT04131491|Procedure|Lumbar puncture|Lumbar puncture for AD biomarker fluid analysis
15839128|NCT04131478|Genetic|Pharmacogenetic testing|Pharmacogenetic testing for TNF alfa
15839129|NCT04131465|Diagnostic Test|Home HIV self-testing|Offer of 3 OraQuick HIV self-test kits
15839130|NCT04131465|Diagnostic Test|Home HIV rapid testing|Offer of HIV rapid testing with Alere Determine HIV-1/2
15839131|NCT04131465|Diagnostic Test|Home HIV self-testing and rapid testing|Offer of 3 OraQuick HIV self-test kits and HIV rapid testing with Alere Determine HIV-1/2
15839132|NCT04131452|Other|Filling out the forms including IDAS-II, BAI, SF-36 and FSFI|Participants will fill out certain validated forms including the expanded version of the inventory of depression and anxiety symptoms (IDAS-II), Beck Anxiety inventory (BAI), Short Form Survey (SF-36) and Female Sexual Function Index (FSFI).
15839134|NCT04131426|Drug|Remune|Remune is intended for the dietary management of disease related malnutrition especially in patients with precachexia or cachexia due to cancer or COPD
15839135|NCT04131426|Other|EXCAP©®|EXCAP©® is a home-based low-to-moderate intensity program that employs a tailored walking prescription and total body resistance exercises
15839136|NCT04131413|Drug|pNGVL4aCRTE6E7L2|The dose escalation will start from the lowest dose level of 0.3 mg. This dose cohort will consist of 3 participants and a monitoring period of one week after the final dose mandated. If there are 0 participants in the 0.3 dose level cohort that experience dose limiting toxicities (DLT), a new cohort of 3 participants will be vaccinated at the 1.0 mg dose level. If there are 0 participants in the 1.0 mg dose level that experience DLT, then a new cohort of 3 participants will be vaccinated at the 3.0 mg dose level. If there is 1 participant experiencing DLTs, an additional cohort of 3 subjects will be enrolled and treated at the current dose level. If there are 2 or more participants experiencing DLTs in the 3 or additional cohort of 3 vaccinated at the current dose level, then the next lower dose level will be determined as the Maximum Tolerated Dose (MTD).
15839137|NCT04131400|Diagnostic Test|Visual Acuity Testing and Retinal Imaging|All clinical and para- clinical tests including visual acuity assessment, perimetry, optical coherence tomography (OCT), enhanced depth- OCT, OCT angiography, color fundus, autofluorescence and infrared fundus photography will be performed
15839138|NCT04131387|Device|LIPUS-1|After installing the disposable treatment head coat, the pelvic floor muscles, ligaments, etc. were treated with an ultrasonic therapeutic apparatus; after the treatment, the disposable treatment head coat was removed. Treated twice a week for 6 weeks.
15839139|NCT04131387|Device|LIPUS-2|The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.
15839140|NCT04131374|Behavioral|Reminiscence Therapy|Virtual reality scenarios will be used to delivered reminiscence therapy with each caregiving dyad (i.e. person living with dementia; family member).
15839141|NCT04131361|Other|Ultrasound-guided Inferior vena cava diameter dependent colloid challenge versus routine crystalloid strategy Fluid replacement|The inferior vena cava largest and smallest diameters will be measured proximal to the opening of the hepatic veins in the longitudinal axis with the M-mode using a 8-2 MHz curved array ultrasound probe placed longitudinally in the subcostal region.
15839142|NCT04131348|Procedure|botulinum toxin type A|From to December 2016 to December 2018, a single-center prospective comparative study was performed in 80 patients with LMIH at our tertiary center.
15839143|NCT04131335|Drug|AEONTM Repair|Lubricating eye drops
15839144|NCT04131335|Other|Routine post-operative eye drops used.|Dexamethasone 0.1% eye drops QDS for 4 weeks Chloramphenicol 0.5% eye drops QDS for 1 week
15839145|NCT04131322|Drug|Amgevita 40Mg Solution for Injection|Adalimumab 40Mg Solution for Injection
15839146|NCT04131322|Drug|HUMIRA 40Mg Solution for Injection|Adalimumab 40Mg Solution for Injection
15839173|NCT04131062|Behavioral|Electronic Consent (iPad)|Participants who receive the intervention will be consented using an electronic app presented via iPad and developed according to the Sage eConsent framework.
15839174|NCT04131049|Other|High GI calculated by CC (CHGI)|This test meal with high GI were served as a breakfast after 8-hours fasting and participants were asked to consume the meal in full, within 20 min.
15840084|NCT04123392|Drug|Busulfan (BU)|Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.
15839147|NCT04131309|Drug|Daratumumab|As of Protocol Amendment 1, all new subjects are dosed with daratumumab subcutaneous injection (SC) co-formulated with recombinant human hyaluronidase rHuPH20. Subjects who already began treatment with daratumumab intravenous (IV) infusion (i.e., prior to Am 1) switch to SC on the next administration date according to the protocol schedule. Subjects receive daratumumab IV at a dose of 16 mg/kg and daratumumab SC at a fixed dose of 1800 mg for the first 8 weeks (Cycles 1 and 2) of treatment and then every 2 weeks for 4 cycles (Cycles 3 to 6) and then every 4 weeks until progression of disease (according to MOD-PFS), unacceptable toxicity or subsequent therapy, for a maximum of 2 years in total. All treatment cycles are 4 weeks (28 days) in length.
15839148|NCT04131309|Drug|Bortezomib Injection|Subjects who do not achieve either a hematologic VGPR or better, OR a hematologic PR with a major organ response by Cycle 4 Day 1 may receive at Investigator's discretion, in addition to daratumumab, bortezomib at a dose of 1.3 mg/m2 weekly for a maximum of 6 cycles as a subcutaneous injection
15839149|NCT04131309|Drug|Dexamethasone oral tablet|Subjects who do not achieve either a hematologic VGPR or better, OR a hematologic PR with a major organ response by Cycle 4 Day 1 may receive at Investigator's discretion, in addition to daratumumab low dose dexamethasone at a maximum total dose of 20 mg weekly.
15839150|NCT04131296|Diagnostic Test|influenza screening|positive influenza screening
15839151|NCT04131283|Drug|Epinephrine|Vasoconstrictor solution is applied on the surface of the attached gingiva and on the gingival sulcus.
15839152|NCT04131270|Behavioral|Planning + Education|"Planning: Participants will fill in the planning forms that efer to replacing sedentary behavior with physical activity.
~The following behavior change techniques are included in the planning intervention protocol: action planning, barrier identification, prompting self-talk, relapse prevention/coping planning. Applications of all behavior change techniques would include references to planning."
15839153|NCT04131270|Behavioral|Education|The education would include extended sedentary behavior and physical activity education, delivered face-to-face by the experimenters. The education includes: (1) the behavioral guidelines, tailored to age and health status of the participants, (2) the examples of exercises and their metabolic equivalent, and (3) the education about ways to break sedentary behavior with active breaks.
15839154|NCT04131257|Behavioral|Nurse-led Continuum of Care|This will be a nurse-led community level prevention program for individuals with diabetes and pre-diabetes, where participants in intervention group will receive nurse-led continuum of care while control group will receive usual diabetic care.
15839155|NCT04131244|Procedure|In vitro activation of primordial follicles by PTEN inhibitor and AKT stimulator|After laparoscopic unilateral oophorectomy, ovarian medulla would be dissected from cortex. After fragmentation of 2 cm square ovarian cortex into smaller pieces they would be incubated PTEN inhibitor and AKT stimulator for 48 hours. Finally we will auto graft these fragments beneath to the fallopian tube peritoneal surface.
15839156|NCT04131231|Drug|microparticles packaging methotrexate (MPs-MTX)|50ml, intrapleural infusion, day5,6,7,8
15839157|NCT04131231|Drug|recombinant human interleukin-2(rhIL-2)|50ml, intrapleural infusion, day5,8,11
15839158|NCT04131218|Drug|Sugammadex|Each patient received a single dose administration of sugammadex 2mg/kg according to the ideal body weight (IBW) at reappearance of the second twitch of the train-of-four (TOF).
15839159|NCT04131205|Diagnostic Test|Magnetic Resonance Imaging|We will assess the role of magnetic resonance (MR) in mHE diagnosis with emphasis on multimodal imaging technique
15839160|NCT04131192|Drug|Z650|250 or 300 or 200 mg/d, starting on the 2nd day, once a day, continuous administration, or about half an hour after a meal
15839161|NCT04131192|Drug|Gemcitabine|Gemcitabine will be administered intravenously at 1000 mg/m2 on Days 1, 8, of a 21-day cycle ，for 4-6 cycles
15839162|NCT04131179|Behavioral|Youth Culturally Adapted Manual Assisted Psychological Therapy (Y-CMAP)|"Y-CMAP is a manual assisted brief psychological intervention based on the principles of Cognitive Behaviour Therapy (CBT), including 8-10 sessions delivered over three months.
~This intervention includes evaluation of the self-harm attempt, psycho education, crisis skills, problem solving and simple cognitive techniques to manage emotions, negative thinking,relapse prevention strategies and training on anger management and assertiveness."
15839163|NCT04131166|Behavioral|Mediterranean diet|A Mediterranean-type diet will be consumed for 4 to 8 weeks in the weight stable state with all meals provided.
15839164|NCT04131166|Behavioral|Low-carbohydrate, ketogenic diet|A low-carbohydrate, ketogenic diet will be consumed for 4 to 8 weeks in the weight stable state with all meals provided.
15839165|NCT04131166|Behavioral|Low-fat diet|A low-fat diet will be consumed for 4 to 8 weeks in the weight stable state with all meals provided.
15839166|NCT04131166|Other|Annual follow-up testing for 5 years|Annual follow-up testing with no restrictions on dietary intake during periods between annual testing.
15839167|NCT04131153|Procedure|"three-step radiofrequency ablation"|"After destroying the main blood supply of the tumor, extracting the blood in the tumor, reducing the blood flow in the tumor and shrinking the tumor volume, the remaining tumor was then treated with radiofrequency ablation, namely the three-step radiofrequency ablation with one block, two inhalation and three damages."
15839168|NCT04131153|Procedure|radiofrequency ablation|Conventional radiofrequency ablation
15839169|NCT04131127|Device|Sentinel Device|Sentinel Device used during TAVI in a Low Risk Patient
15839170|NCT04131101|Behavioral|Community Organizing|The intervention will be community organizing and will consist of engaging tenants, health providers, legal service staff, social service agencies and advocacy organizations (e.g. ACORN). Each building team will identify initial priorities and then invite all building members to discuss and to finalize, as well as a plan for change. Building teams will engage in advocacy to TCHC and its representatives, and other city departments as appropriate. Engaging in advocacy will consist of a wide range of activities but essentially means presenting evidence (e.g. personal experiences, data) to policymakers and decision makers to affect change.
15839171|NCT04131088|Other|Follow up of midlines|The follow-up data to be collected will be recorded on a monitoring logbook that will follow the patient (Appendix 4). The latter will be involved in the follow-up of his data insofar as he will be able to solicit the various professionals performing care on his midline in order to aim at the exhaustiveness of the filling of the book.
15839172|NCT04131075|Procedure|Coronary Angiography and Multimodal Coronary Physiology Study (FFR, CFR, HMR)|Coronary Angiography according to clinical indication and Multimodal Coronary Physiology Study (FFR, CFR, HMR) for functional assessment of intermediate coronary lesions
15839231|NCT04130594|Other|placebo|placebo
15839175|NCT04131049|Other|Low GI calculated by CC (CLGI)|This test meal with low GI were served as a breakfast after 8-hours fasting and participants were asked to consume the meal in full, within 20 min.
15839176|NCT04131049|Other|High GI calculated by FII (FHGI)|This test meal with high GI were served as a breakfast after 8-hours fasting and participants were asked to consume the meal in full, within 20 min.
15839177|NCT04131049|Other|Low GI calculated by FII (FLGI)|This test meal with low GI were served as a breakfast after 8-hours fasting and participants were asked to consume the meal in full, within 20 min.
15839178|NCT04131036|Other|assessment of joint health and bone density|We propose to study longitudinal joint and bone density changes in patients with severe Hemophilia A.
15839179|NCT04131023|Behavioral|Breezing Metabolic Rate Tracking|Metabolism (indirect calorimetry) data were collected every two weeks over 13 weeks of gestation across the second trimester (weeks 13-27) and the values obtained were provided to the participant without health education.
15839180|NCT04131010|Device|single operator video cholangioscopy|The technique provides digital imaging with a higher resolution and improved maneuverability compared to the legacy fiberoptic system. In addition, the working channel was enlarged to a diameter of 1.3 mm. Retrospective data showed an overall technical success rate for single-operator video pancreatoscopy (SOVP) guided treatment of pancreatic stones of 95%
15839181|NCT04130997|Biological|Ublituximab|Ublituximab (TG-1101) is a recombinant chimeric monoclonal antibody targeting CD20, available as a 25 mg/mL concentrate for intravenous use, supplied by TG Therapeutics, Inc.
15839182|NCT04130984|Device|EZ-IO|The insertion site locates at 1 cm medial tibial tuberosity. EZ-IO (U.S. Teleflex® Corporation) will be used with an adult 15G needle. Pull out the needle when having a sense of frustration, withdraw the bone marrow with the syringe, bolus 20 mL of normal saline to open intramedullary path and begin drug resuscitation at the same time. The retention time of IO route should be less than 24 h, and venous access should be established after winning rescue time as soon as possible to continue treatment.
15839183|NCT04130971|Other|No intervention, just observation|No intervention, just observation of the differences between groups and within patients.
15839184|NCT04130958|Device|Intermittent Theta Burst Transcranial Magnetic Stimulation (Active)|iTBS-TMS is a noninvasive neuromodulation technique that uses a powerful magnet to induce focal electrical currents in target brain regions.
15839185|NCT04130958|Device|Intermittent Theta Burst Transcranial Magnetic Stimulation (Sham)|The sham version of iTBS-TMS involves placing the magnet over the same target brain region but the device will not be turned on during the treatment. There will be two electrodes placed on the scalp that mimic the sensation of iTBS-TMS but does not induce focal electrical currents.
15839186|NCT04130945|Other|erector spina plane block, cost analysis|in preopererative period, ESP block is going to utilise for postoperative analgesia for patients who undergo laparoscopic procedure and cost analysis will make after the end of 24 hour of operation
15839190|NCT04130906|Device|Intermittent Theta Burst Stimulation|iTBS will be delivered to the left dorsolateral prefrontal cortex (DLPFC) at 80% of resting motor threshold using standard stimulation parameters; triplet-bursts will be delivered at high frequency (50 Hz) with an inter-burst interval of 200 ms. Each TBS train will last 2 seconds and consists of 10 triplet-bursts (30 pulses). Each iTBS session will involve 10 TBS trains repeated every 10 seconds for 190 seconds, with a total number of 600 pulses delivered during each session.
15839191|NCT04130906|Device|Sham Intermittent Theta Burst Stimulation|Sham stimulation will be delivered left dorsolateral prefrontal cortex (DLPFC) using the same parameters as real iTBS however, a sham coil will be used. The sham coil makes the same noise and creates a similar sensation on the scalp as the real coil but does not produce a magnetic field.
15839192|NCT04130893|Behavioral|stimulation of G13 then G15|Study participant randomized into arm A will undergo a stimulation of point G13 at session N°2, then stimulation of point G15 at session N°3.
15839193|NCT04130893|Behavioral|stimulation of G15 then G13|Study participant randomized into arm B will undergo a stimulation of point G15 at session N°2, then stimulation of point G13 at session N°3.
15839194|NCT04130880|Diagnostic Test|Turkish Montreal Children's Hospital Feeding Scale|The Turkish version of the Montreal Children's Hospital Feeding Scale, and the Behavioral Pediatrics Feeding Assessment Scale will be completed.
15839195|NCT04130867|Procedure|pHRM|Pharyngeal high--resolution manometry (pHRM) provides direct and objective measurement of pressure changes in the pharynx that characterize basic mechanisms of swallowing.
15839196|NCT04130867|Procedure|VFSS|Videofluoroscopic Swallow Study (VFSS) enables real-time visualization of bolus flow during swallow movement.
15839197|NCT04130854|Drug|APX005M, mFOLFOX, and Radiation Therapy 5Gy x 5 days|"APX005M 0.3mg/kg intravenously on day 3 of radiation and on day 3 of cycles 1-5 of mFOLFOX
~Short course radiation therapy 5 Gy x 5 days
~Oxaliplatin 85mg/m2 intravenous day 1 of each cycle
~Leucovorin 400mg/m2 IV Day 1 of each cycle
~5-FU 2400 mg/m2 continuous infusion over 46 hours of each cycle"
15839198|NCT04130854|Drug|mFOLFOX and Radiation Therapy 5Gy x 5 days|"Short course radiation therapy 5 Gy x 5 days
~Oxaliplatin 85mg/m2 intravenous day 1 of each cycle
~Leucovorin 400mg/m2 IV Day 1 of each cycle
~5-FU 2400 mg/m2 continuous infusion over 46 hours of each cycle"
15839199|NCT04130841|Procedure|Internal Limiting Membrane Peeling|After removal of the epiretinal membrane, indocyanine green staining will be used to determine the internal limiting membrane (ILM) peeled off with the epiretinal membrane. (Group 1: spontaneous ILM peeling) If it is confirmed that the internal limiting membrane is not peeled together, the investigators determine whether the active Internal limiting membrane peeling is performed by 1:1 randomization immediately during surgery. (Group 2: Active ILM peeling, Group 3: no ILM peeling) The outcomes of the three groups will be compared.
15839200|NCT04130828|Drug|Ferrous Fumarate|Ferrous fumarate 200 mg PO PC
15839201|NCT04130815|Drug|Inhaled furosemide|4ml of 10mg/ml solution of furosemide nebulized with small and large droplet sizes and inhaled with different breathing patterns
15839202|NCT04130802|Drug|OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL|OCS-01 eye drops
15839203|NCT04130802|Drug|Placebo|Vehicle eye drops
15839378|NCT04129463|Device|Conventional trabeculotomy|Conventional trabeculotomy in Buphthalmous using rigid Hans trabeculotome
15839204|NCT04130789|Other|compare data patterns by data-driven algorithms to determine sepsis|compare data patterns by data-driven algorithms including machine learning and multi-dimensional modelling to reliably determine sepsis
15839205|NCT04130789|Other|compare data patterns by data-driven algorithms to predict sepsis-related mortality|compare data patterns by data-driven algorithms including machine learning and multi-dimensional modelling to to predict sepsis-related mortality
15839206|NCT04130776|Diagnostic Test|Measurement of four prostate-specific kallikreins for the 4Kscore Test when serum stored uncentrifuged|The 4Kscore Test helps clarify the biopsy decision-making process by determining a patient specific probability for finding aggressive, Gleason score 7 or higher prostate cancer upon biopsy. These are the aggressive prostate cancers that always require medical treatment or intervention. The 4Kscore Test relies on the measurement of four prostate-specific kallikreins in the blood: Total PSA, Free PSA, Intact PSA, and Human Kallikrein 2 (hK2). The blood test results are combined in an algorithm with patient age, digital rectal exam (nodules, no nodules), and prior negative biopsy (yes, no) to give physicians a personal score for each patient. The 4Kscore Test predicts the risk percent score from <1% to >95% of a man having aggressive cancer in a prospective biopsy.
15839207|NCT04130763|Biological|FMT capsule|FMT capsules administration starts in the first week of enrollment. Capsules are taken for three consecutive days in the first week. From week 2, anti-PD-1 therapy will be administrated in combination with the maintenance dose of FMT treatment once every two weeks for up to 6 times.
15839208|NCT04130750|Combination Product|treatment of drug screening|Patients in experimental group will receive a drug screening in vitro to select sensitive chemotherapy drug. And neoadjuvant chemotherapy will be performed according the results of drug screening.
15839209|NCT04130737|Device|TORUS Stent Graft System|The TORUS Stent Graft is an intravascular prosthesis intended to improve blood flow in the area in which it is implanted and the TORUS Stent Graft Delivery System is a standard pin-and-pull delivery system used to implant the SG in the desired area. Use of the TORUS Stent Graft allows for improving blood flow in the peripheral vasculature.
15839210|NCT04130724|Diagnostic Test|Blood ketone testing|Ketone testing will be done using a blood beta-hydroxybutyrate (BHB) test at least five (5) times per day.
15839211|NCT04130724|Diagnostic Test|Breath ketone testing|Ketone testing will be done using a breath acetone (BrAce) test at least five (5) times per day.
15839212|NCT04130711|Other|Visual virtual Conditions|"The objective is to evaluate if certain virtual visual conditions can increase the illusion of movement induced by the tendon vibration of the upper limb.
~Thirty healthy volunteers and 20 post-stroke subjects will test 3 different situations of vibration applications, with no EEG Neurofeedback session. It will be applied to the subject (healthy and post-stroke) according to a randomized order a vibrator for a few minutes on his non-dominant (or deficit) hand hidden from view, with a screen representing a static virtual hand, then a vibrator on his hand hidden with a screen representing an animated virtual hand, then a vibrator on his hand hidden with a screen representing an empty background."
15839213|NCT04130711|Other|Standard EEG|Twenty healthy volunteers test 3 separate electroencephalographic recording conditions without Neurofeedback. It will be applied to the subject an EEG headset recording brain activity during the application of vibration stimulation producing the illusion of movement on the non-dominant hand or during a task Mental imagery of the upper limb, or during the joint application of vibratory stimulation and a mental imaging task on the affected upper limb in a randomized order.
15839214|NCT04130711|Other|Neurofeedback Training Stroke Patients|The post-stroke subject is evaluated on clinical tests (FMA, ARAT, MAL, NHPT, Finger Tapping test) during the first visit. Then, he performs 12 sessions of NFB (on his deficit member) lasting 45 minutes, spread over 6 weeks, depending on the feedback modality that has been drawn randomly (visual or visuo-vibratory). A second visit after the first NFB session and a third visit after the last NFB session evaluates the motor skills of the trained upper limb (FMA, ARAT, MAL, NHPT, Finger Tapping test) and a satisfaction questionnaire is given to the subject for evaluate tolerance and satisfaction with the feedback modality assigned. Evaluation of changes of EEG sensorimotor rhythms at the end of the program.
15839215|NCT04130698|Behavioral|Distress Tolerance|The group-level intervention is comprised of one 2-hour weekly group sessions with overweight smokers to learn skills and strategies consistent with distress tolerance intervention to quit smoking and lose weight.
15839216|NCT04130698|Drug|transdermal nicotine patch|Participants will use the patch for 8 weeks as outlined by the recommended usage for steps 1-3 going from 21mg for 4 weeks, 14mg for 1 week, and 7mg for 1 week.
15839217|NCT04130698|Behavioral|Active Health Control|The group-level intervention is comprised of one 2-hour weekly group sessions with overweight smokers to learn skills and strategies consistent with psychoeducation intervention to quit smoking and lose weight.
15839218|NCT04130685|Diagnostic Test|Allosure Test|Venous Blood Draw
15839219|NCT04130672|Procedure|Hot nasal packing with hot saline irrigation for hemostasis after adenoidectomy|After hot packing nasopharyngeal irrigation with 50 C saline
15839220|NCT04130672|Procedure|Cold nasal packing with cold saline irrigation for hemostasis after adenoidectomy|After cold packing nasopharyngeal irrigation with 22 C saline
15839221|NCT04130659|Device|Marial® + PPI (generic omeprazole)|Marial®: 1 stick of Marial® twice a day after meals from day 1 to 28 Omeprazole 20 mg cps: once a day from day 1 to 28
15839222|NCT04130659|Other|PPI alone (generic omeprazole)|Omeprazole 20 mg cps: once a day from day 1 to 28
15839223|NCT04130646|Device|Transcranial Magnetic Stimulation|transcranial magnetic stimulation delivers magnetic pulses to the brain through the scalp/skull
15839224|NCT04130646|Device|transcutaneous auricular vagus nerve stimulation (taVNS)|non-invasive vagus nerve stimulation delivers electricity to the ear
15839225|NCT04130633|Drug|Placebo|Placebo vapor (distilled water)
15839226|NCT04130633|Drug|THC|Pure THC vapor
15839227|NCT04130633|Drug|Alpha-Pinene|Pure alpha-pinene vapor
15839228|NCT04130620|Diagnostic Test|Applied Kinesiology|An Applied Kinesiology muscle test will be supplemented by a single blood draw for validation.
15839229|NCT04130607|Other|Conceptual teaching|"The present study is designed to contrast two instructional methods - explicit instruction in likelihood ratios and pretest/posttest probabilities versus implicit instruction based on presentation of multiple cases. These will be compared to a no intervention control group."
15839230|NCT04130594|Biological|BVRS-GamVac|a vector vaccine for the prevention of the Middle East respiratory syndrome, lyophilisate for the preparation of a solution for intramuscular administration
15839232|NCT04130581|Other|Transcranial Magnetic Stimulation (TMS)|TMS is a safe and non-invasive technique, which involves the generation of brief magnetic pulses applied to the head through a coil. The magnetic pulses pass through the scalp and skull and induce weak electric currents in the neural tissue directly underneath the coil. When TMS is applied in repetitive, patterned trains of pulses (rTMS), it can induce cortical plasticity specifically in the targeted brain region.
15839233|NCT04130568|Diagnostic Test|INO survey|Garvin's Learning organisation tool
15839234|NCT04130555|Device|CELLIS Rectopexy (Porcine Acellular Dermal Matrix, PADM)|Biological membrane used in Laparoscopic Ventral Rectopexy (LVR) or robotic assisted rectopexy
15839235|NCT04130542|Biological|LVGN6051|IV infusion once every 3 weeks (Q3W).
15839236|NCT04130529|Behavioral|Adjusted group CBT-i for Bipolar disorder|CBT-i includes sleep scheduling/sleep compression, stimulus control, relaxation, cognitive interventions and sleep hygiene advice. In addition components targeting circadian rhythm problems and problems with very high or very low levels of activity are included.
15839237|NCT04130529|Other|Sleep lectures|Lectures on the topic of sleep.
15839238|NCT04130516|Drug|LNS8801 -Small molecule, orally bioavailable, selective agonist of GPER|LNS8801 -Small molecule, orally bioavailable, selective agonist of GPER
15839239|NCT04130516|Biological|Pembrolizumab - anti-PD-1 antibody|pembrolizumab- anti-PD-1 antibody
15839240|NCT04130503|Device|PAP|Positive airway pressure (PAP) treatment of obstructive sleep apnea (OSA).
15839241|NCT04130503|Behavioral|HLE|All patients (randomized and non-randomized) will receive a healthy lifestyle education (HLE) intervention focused on secondary stroke prevention.
15839242|NCT04130477|Device|Tunnel attachments and light Nickel Titanium wire|Tunnel attachments planned virtually and light Nickel Titanium wire
15839243|NCT04130477|Device|Clear Aligner therapy|Clear Aligner therapy
15839244|NCT04130464|Drug|Ropivacaine Infusion from ON-Q Pump|Infusion of 0.2% ropivacaine at 8 mL/hour for 72 hours
15839245|NCT04130464|Drug|Ropivacaine + Ketorolac Infusion from ON-Q Pump|Infusion of 0.2% ropivacaine + 30 mg ketorolac at 8 mL/hour for 72 hours
15839246|NCT04130464|Drug|Normal Saline Infusion from ON-Q Pump|Infusion of 0.9% normal saline at 8 mL/hour for 72 hours
15839247|NCT04130451|Drug|PYODINE AND TALC SLURRY|"pyodine Povidone-iodine is a broad spectrum antiseptic for topical application in the treatment and prevention of wound infection. It may be used in first aid for minor cuts, grazes, burns, abrasions and blisters.
~TALC a white, grey, or pale green soft mineral with a greasy feel, occurring as translucent masses or laminae and consisting of hydrated magnesium silicate"
15839248|NCT04130438|Drug|Nebivolol|The intervention to be tested is oral beta blocker (nebivolol 2.5 mg) vs. calcium channel blocker (Diltiazem-SR 120 mg) vs. placebo. Once enrolled, baseline data will be gathered and subjects will be randomly assigned to a treatment arm. Subjects will be instructed to take their assigned study drug once a day for 30 days.
15839249|NCT04130438|Drug|Diltiazem|The intervention to be tested is oral beta blocker (nebivolol 2.5 mg) vs. calcium channel blocker (Diltiazem-SR 120 mg) vs. placebo. Once enrolled, baseline data will be gathered and subjects will be randomly assigned to a treatment arm. Subjects will be instructed to take their assigned study drug once a day for 30 days.
15839250|NCT04130438|Other|Placebo|The intervention to be tested is oral beta blocker (nebivolol 2.5 mg) vs. calcium channel blocker (Diltiazem-SR 120 mg) vs. placebo. Once enrolled, baseline data will be gathered and subjects will be randomly assigned to a treatment arm. Subjects will be instructed to take their assigned study drug once a day for 30 days.
15839251|NCT04130425|Device|Hely & Weber MTC Fracture Brace|Prefabricated muenster orthosis
15839252|NCT04130425|Device|Thermoplastic orthosis|Muenster orthosis fabricated out of thermoplastics and secured with Velcro
15839253|NCT04130425|Device|Delta cast orthosis|Muenster orthosis fabricated out of Delta Cast and secured with Velcro
15839254|NCT04130412|Procedure|open release|Open release of lateral retinaculae
15839255|NCT04130399|Radiation|Stereotactic Body Radiation Therapy (SBRT)|Patients will receive 5 fractions of SBRT delivered over a five-day period. Treatment may be delivered over 2 weeks, provided that the patient receives at least 2 fractions per week.
15839256|NCT04130399|Drug|FOLFIRINOX|Participants in this trial will receive neoadjuvant and adjuvant FOLFIRINOX chemotherapy for 6 cycles (1 cycle = 14 days) per routine guidelines
15839257|NCT04130386|Behavioral|Motivational Interviewing|Participants receiving MI
15839258|NCT04130386|Behavioral|e-education|Participants receiving e-education
15839259|NCT04130373|Procedure|Autologous fat grafting procedure|Surgical intervention based on the injection of autologous fat grafting after radical or conservative breast surgery and breast reconstruction.
15839260|NCT04130373|Procedure|Breast reconstruction|Breast reconstructive procedures after oncological radical or conservative breast surgery
15839261|NCT04130360|Behavioral|Problem-solving|The steps of problem-solving are explained to the participants. Then, they are presented two conflictive situations and they are asked to apply the problem-solving steps to find a solution. Once they finish, they are asked to apply the steps in a conflictive situation they have experience in the last month. In the end, they are reminded of the steps and encouraged to practice them in their daily conflicts.
15839262|NCT04130334|Procedure|After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea|After mechanical trephination, horizontal meridian of donor's cornea sutured to horizontal meridian of recipient cornea
15839263|NCT04130334|Procedure|: After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea|: After mechanical trephination, horizontal meridian of donor's cornea sutured to vertical meridian of recipient cornea
15839264|NCT04130321|Dietary Supplement|Camu camu|3 capsules of camu camu powder (500 mg / capsule) daily during 12 weeks
15839265|NCT04130321|Dietary Supplement|Placebo|3 capsules of placebo daily during 12 weeks
15839266|NCT04130308|Other|Retrun to run protocol|Progressive return to run protocol for patients after ACL-R
15839267|NCT04130295|Other|Wearable intensive nerve stimulator|The wearable device consists of 2 leads that provide biphasic, with alternating lead phase, asymmetrical rectangular current at a pulse duration of 0.28 msec, a randomly varying pulse frequency between 60-100 Hz, with a maximum intensity of 100mA.
15839268|NCT04130282|Biological|Pfs25-IMX313/Matrix-M1|3 doses of 10µg Pfs25-IMX313 in 50 µg Matrix-M1 on days 0, 28 and 56
15839269|NCT04130269|Other|No intervention|Questionnaires, lab-run
15839270|NCT04130256|Device|Electronic Pill Bottle|Electronic bottles that can beep and blink to send medication use reminders, record medication use data, and upload medication use data to a secure server.
15839271|NCT04130243|Other|Blood test|Withdrawal of (extra) blood to measure serum biomarkers with a blood test
15839272|NCT04130230|Drug|Neostigmine|Neostigmine continuous infusion plus standard therapy for sepsis and septic shock.
15839273|NCT04130230|Drug|Standard therapy|Standard therapy for sepsis and septic shock
15839274|NCT04130217|Procedure|addition of positive end expiratory pressure in ventilated patients|patients will be intraoperatively mechanically ventilated with PEEP of 5 cmH2O.
15839275|NCT04130217|Procedure|addition of positive end expiratory pressure and recruitment maneuver in ventilated patients|patients will be intraoperatively mechanically ventilated with PEEP of 5 cmH2O and intermittent four times of RM consisting of maintaining airway pressure 40 cmH2O for 40 sec.
15839276|NCT04130204|Drug|DYV700|Topical Transdermal Delivery Lotion with Actives
15839277|NCT04130204|Other|Placebo|Topical Transdermal Delivery Lotion without Actives
15839278|NCT04130178|Drug|Nerve block|block of the digital nerves in rheumatoid arthritis patient
15839279|NCT04130178|Drug|Saline injection|subcutaneous saline injection
15839280|NCT04130165|Other|Matched donor human milk|Milk from donor mothers will be sorted according to their secretor status. This milk will be provided to infants in the intervention (experimental) arm.
15839281|NCT04130152|Drug|Palbociclib|Palbociclib 125 mg once daily, day 1 to day 21, followed by 7 days off treatment in a 28-day cycle
15839282|NCT04130152|Drug|Letrozole|Letrozole: oral, 2.5 mg per day continuously. during the 28-day cycle.
15839283|NCT04130139|Other|oocyte pick up simulator|oocyte pick up simulation
15839284|NCT04130126|Behavioral|Taking cold showers|Showering behaviour
15839285|NCT04130100|Biological|Low Dose of Mesenchymal stem cell|Mesenchymal stem cell injection
15839286|NCT04130100|Biological|High Dose of Mesenchymal stem cell|Mesenchymal stem cell injection
15839287|NCT04130100|Drug|Sodium Hyaluronate|Sodium Hyaluronate injection
15839288|NCT04130087|Drug|Selegiline Hydrochloride 10 MG|Single 10mg tablet of Selegiline Hydrochloride
15839289|NCT04130087|Drug|Placebo|Single Placebo Tablet, identical appearance to experimental tablet.
15839290|NCT04130074|Device|duplex doppler ultra sound and CT|graded compression US done in different positions then take MSCT with contrast on abdomen to compare with
15839291|NCT04130061|Biological|Human Amniotic Membrane|Epicardial application of human amniotic membrane during cardiac surgery
15839292|NCT04130048|Diagnostic Test|Ultrasound Elastography|Ultrasound elastography aims to assess the stiffness of a tissue, submitting it to an ultrasound impulse.
15839293|NCT04130022|Device|Point-of-Care Ultrasound|Portable ultrasonography done at the bedside.
15839294|NCT04130009|Procedure|Tourniquet use|Use of Tourniquet in The TKA
15839295|NCT04129996|Drug|camrelizumab in combination with nab-paclitaxel and famitinib|camrelizumab in combination with nab-paclitaxel and famitinib for triple negative breast cancer
15839296|NCT04129983|Combination Product|Drugs and Stimulation|60 cases of sudden deafness were inquired about their medical history and examined by hearing and cranial magnetic resonance. They were randomly divided into two groups and given different treatments. The hearing test was repeated every 7 days. One month and three months after the treatment, the hearing examination was reexamined.
15839297|NCT04129970|Device|Intermittent Theta Burst Stimulation|iTBS will be delivered to the left dorsolateral prefrontal cortex (DLPFC) at 80% of resting motor threshold using standard stimulation parameters; triplet-bursts will be delivered at high frequency (50 Hz) with an inter-burst interval of 200 ms. Each TBS train will last 2 seconds and consists of 10 triplet-bursts (30 pulses). Each iTBS session will involve 10 TBS trains repeated every 10 seconds for 190 seconds, with a total number of 600 pulses delivered during each session.
15839298|NCT04129957|Procedure|Placement of dental implants|All the included patients underwent the placement of at least one implant in either upper jaw, or lower jaw, or both.
15839299|NCT04129944|Drug|UBX0101|Investigational drug intra-articular injection
15839300|NCT04129944|Other|Placebo|Placebo intra-articular injection
15839301|NCT04129931|Drug|MCT|Mix 1-2 packets, as instructed by a physician, into liquid or food three times daily
15839302|NCT04129931|Drug|Clazakizumab|12.5 mg subcutaneous injection given once every 4 weeks for 16 weeks. Lab driven dose reductions will be made based on safety lab data. If criteria are met for dose reduction, the participant will be reduced to a 6.25 mg dose.
15839303|NCT04129931|Drug|Broncho-Vaxom|7 mg taken orally once a day, on an empty stomach, for 16 weeks
15839304|NCT04129931|Drug|Imatinib Mesylate|Two 100 mg tablets orally once a day with a meal and an 8 oz glass of water for 2 weeks. If the drug is well tolerated, participants will titrate up to four 100 mg tablets once a day with a meal and an 8 oz glass of water for 14 weeks. Safety labs will be collected at each study visit to monitor the tolerability of each participant.
15839305|NCT04129931|Drug|Cavosonstat|50 mg capsule orally twice a day for 16 weeks.
15839306|NCT04129931|Other|Placebo|"MCT Matching Placebo: MCT matching placebo packets. Mix 1-2 packets, as instructed by a physician, into liquid or food three times daily
~Clazakizumab Matching Placebo: 12.5 mg subcutaneous saline injection given once every 4 weeks for 16 weeks.
~Broncho-Vaxom Matching Placebo: 7 mg matching placebo taken orally once a day on an empty stomach for 16 weeks
~Imatinib Matching Placebo: Two 100 mg placebo tablets orally once a day with a meal and an 8 oz glass of water for 2 weeks. Then four 100 mg placebo tablets once a day with a meal and an 8 oz glass of water for 14 weeks.
~Cavosonstat Matching Placebo: 50 mg matching placebo capsule orally twice a day for 16 weeks."
15839307|NCT04129918|Behavioral|light and sound modification (earplugs and eye masks)|In the experimental group，the patients used earplugs and eye masks during nighttime sleep.
15839308|NCT04129905|Biological|BNP blood sample test|Performed during normal recommended follow-up of the HCM patients.
15839309|NCT04129905|Diagnostic Test|Electrocardiogram|Performed during normal recommended follow-up of the HCM patients.
15839310|NCT04129905|Diagnostic Test|Holter ECG|Performed during normal recommended follow-up of the HCM patients.
15839311|NCT04129905|Diagnostic Test|Echocardiography|Performed during normal recommended follow-up of the HCM patients. Echocardiography at rest and during exercise.
15840202|NCT04122287|Drug|Levofloxacin|levofloxacinn-tetracycline-containing quadruple regimens
15839312|NCT04129905|Diagnostic Test|Air venous plethysmography|Performed specifically for the research. Non invasive, and non painful test evaluating different parameters of venous filling by inflation of an armband around the leg, upright positioning, flexion-extension of the leg. Total duration estimated at 30-45 minute.
15839313|NCT04129905|Diagnostic Test|Upper member arterial Doppler echography with analysis of FMD|Performed specifically for the research. Measurement of the evolution of brachial artery diameter before and after inflation of a armband during 5 minutes. Non invasive and non painful test, duration 30 minutes.
15839314|NCT04129905|Biological|Endothelial function biomarkers|Performed specifically for the research. Blood sample test, 5 minutes.
15839315|NCT04129892|Behavioral|"In Favor of My Resilient Self Academic course"|Assessing the effect of an academic course on student's emotional resilience.
15839316|NCT04129879|Procedure|ABC technique|The intraperitoneal use of methylene blue diluted isotonic sodium chloride solution to visualize endometriotic lesions
15839317|NCT04129866|Behavioral|M-IBM|"In this paradigm, an ambiguous word or two-word phrase related to ASCC is followed by a sentence that resolves the word-sentence meaning as threatening or benign. For example, participants are presented with an ambiguous word or two-word phrase for 1 second. On half the trials the combination of the word/phrase and sentence creates a benign meaning (as in the previous example). On the other half of trials this combination creates an anxious-threat meaning Participants are required to judge the relatedness of the word/phrase and the sentence. Participants are given feedback during training such that judging the anxious-threat combinations to be unrelated and the benign combinations as being related would produce a correct response. In contrast, if participants produce an incorrect response they see incorrect."
15839318|NCT04129866|Behavioral|Control-IBM|Placebo IBM where sentences are not related to anxious threat meaning of cue word.
15839319|NCT04129853|Device|Cyberlegs Xleg|Sit to stand, Stair Climbing, Slope walking, L-test, Hallway walking with the current vs. cyberlegs xleg and cyberlegs vs power knee
15839320|NCT04129840|Other|dual combination|Participants will be started on a dual therapy with half dose of CCB and an ARB. If needed, a) the dose of the CCB will be increased at 4 weeks, and b) the dose of the ARB at 8 weeks, if blood pressure remains uncontrolled ((if target blood pressure is not achieved at this time point (target blood pressure defined as clinic BP </=130/80mmHg in patients <65years and </=140/90mmHg in patients >65years)
15839321|NCT04129840|Other|triple combination|Participants will be started with low dose (1/4) triple combination treatment with CCB, TZD and ARB. If uncontrolled after 4 weeks, dosages of all drugs will be doubled. If after 8 weeks still uncontrolled dosage will be increased to full dose of all three drugs ((if target blood pressure is not achieved at this time point (target blood pressure defined as clinic BP </=130/80mmHg in patients <65years and </=140/90mmHg in patients >65years)
15839322|NCT04129840|Other|Standard of care|Participants will be started on regular dose of CCB with a) addition of TZD at 4 weeks, if needed, b) increase of dose of TZD after 8 weeks, if needed (if target blood pressure is not achieved at this time point (target blood pressure defined as clinic BP </=130/80mmHg in patients <65years and </=140/90mmHg in patients >65years)
15839323|NCT04129827|Other|Clinical, self-reported psychological and biomechanical assessments|"medical check up
~active and passive Range Of Motion (ROM)
~anterior drawer test
~knee's alignment
~modified cincinnati rating system questionnaire (mCRSQ)
~tegner lysholm knee scoring scale (TLKS)
~Tegner Activity Level Score (TALS)
~self-reported psychological questionnaires
~Tampa Scale of Kinesiophobia (TSK)
~ACL Return to Sport after Injury (ACL-RSI) score
~biomechanical tests
~Stability test: to balance on one/two legs on a free to move disc for 30s
~Jump test: i) a maximize jump with both legs; ii) a maximize jump with only one leg; three consecutive jumps; iv) jump coordination path where the patient had to perform a forward-backward-forward jump and a sideway jump on one leg
~Coordination test: a square hurdle was used for the quick test, where the patient had to step in and out with both feet for a total of 15-rep as quickly as possible
~fatigue test: to rise and sit from a chair for 30-rep as quickly and safely as possible"
15839324|NCT04129814|Procedure|Non surgical periodontal therapy|single session full-mouth scaling and root planing
15839325|NCT04129801|Other|Isokinetic Dynamometer|Participants then executed two series of four uninterrupted repetitions of Ext and Flex of both legs, first with the dominant member and subsequently with the non-dominant member, at an angular velocity of 60o/s, with a 60-second interval between series.
15839326|NCT04129801|Other|Bioimpedance|Bioimpedance The BC measurements as FM (% and kg), FFM (% and kg), will be obtained by the indirect noninvasive method of electrical bioimpedance (BIA) 230, 2.0, (Biospace Seoul, Korea). Those evaluated will be standing and positioned on the platform electrodes, barefoot and with their arms extended with their hands on the two supports (electrodes).
15839327|NCT04129788|Drug|Bisacodyl 5 milligram|three doses taken, one per day on three consecutive days
15839328|NCT04129788|Drug|Placebo oral tablet|three doses taken, one per day on three consecutive days
15839331|NCT04129762|Other|Diet without NCS|"A standard diet in terms of macronutrients will be calculated.
~55% Carbohydrates
~20% protein
~25% Lipids The energy calculation will be done with the Harris Benedict formula and a diet with equivalents will be made and then a menu distributed in 5 meals, lasting 7 days.
~The menu will not contain products with NCS."
15839332|NCT04129762|Other|Diet with NCS|"A standard diet in terms of macronutrients will be calculated.
~55% Carbohydrates
~20% protein
~25% Lipids The energy calculation will be done with the Harris Benedict formula and a diet with equivalents will be made and then a menu distributed in 5 meals, lasting 7 days.
~The menu will contain products with NCS."
15839333|NCT04129749|Procedure|Real-Time Analysis Interactive Lab|The Real-Time Analysis Interactive Lab uses an instrumented treadmill, a motion capture system (Vicon System), an electromyographic system as well as a virtual environment is projected on a 180 ° screen. This equipment allows patients to walk spontaneously or at prescribed speeds to a standstill in a virtual and secure virtual reality environment.
15839334|NCT04129736|Drug|Teriflunomide 14 MG|Blood and cerebrospinal fluid is obtained from teriflunomide treated patients with multiple sclerosis
15839335|NCT04129723|Other|Stopping biological therapy|Stopping biological therapy The primary endpoint is clinical relapse at 12 months
15839574|NCT04127851|Drug|Cyclosporine Ophthalmic Emulsion 0.05%|Cyclosporine / one drop / twice daily in both eyes
15839336|NCT04129710|Drug|Ibrutinib|Ibrutinib 560 mg/day daily (starting dose) between days 4 and 28 of each cycle for six cycles. Then Ibrutinib is continued until disease progression, intolerable toxicity, death or up to two years.
15839337|NCT04129710|Drug|Lenalidomide|Oral lenalidomide 25mg/day between days 4 and 24 of each cycle for six cycles. Then lenalidomide is continued until disease progression, intolerable toxicity, death or up to two years.
15839338|NCT04129710|Drug|Methotrexate|Methotrexate 3.5 g/m2 (0.5 g/m2 in 15 min + 3 g/m2 in 3-hr infusion) on day 1
15839339|NCT04129710|Drug|Rituximab|Rituximab 375 mg/m2 conventional infusion on day 1
15839340|NCT04129710|Drug|Etoposide|Etoposide 250 mg/m2 over 3 hours on day3
15839341|NCT04129710|Drug|PEGylated recombinant human granulocyte colony|PEGylated recombinant human granulocyte colony 100 ug/kg subcutaneous injection on day 5.
15839342|NCT04129697|Drug|Dexamethasone or Methylprednisolone|steroids
15839343|NCT04129684|Other|Probiotics|subgingival delivery and lozenges
15839344|NCT04129671|Genetic|No intervention was applied|No intervention was administered
15839345|NCT04129658|Behavioral|Educational outreach visit|Two-four hours of discussion between a cardiologist and the primary care physicians at the PHCC encompassing evidence-based treatment guidelines and counseling upon specific patient cases and their diagnose and treatment for congestive heart failure.
15839346|NCT04129645|Device|URS|"URS is a permanent ureteral stent made of nitinol and covered by a polymer, that is indicated to open strictures in the ureter.
~Study patients who has strictures in the ureter, will be implanted with the URS for long term opening of the stricture."
15839347|NCT04129632|Behavioral|IEPF Wellness Tool|A daily 5 minute mindfulness exercise over 28 days
15839348|NCT04129619|Drug|ORP-101|Oral tablet
15839349|NCT04129619|Drug|Placebo|Oral tablet
15839350|NCT04129606|Diagnostic Test|Computed tomographic cystography|CT cystogram performed after the procedure by the injection of 400mL of 1/4 saline-diluted contrast solution (meglumine ioxitalamate) with low-pressure infusion (60 cm gravity pressure) through the Foley catheter.
15839351|NCT04129593|Behavioral|Self Awakening - Natural Waking|subjects in this arm will be assigned to natural waking and self awaking conditions on Saturday and Sunday. they will be counterbalanced equally between Saturday: natural waking, Sunday: self awakening and Saturday: self awakening, Sunday: natural waking.
15839352|NCT04129593|Behavioral|Snooze - Natural waking|subjects in this arm will be assigned to snooze and natural waking conditions on Saturday and Sunday. they will be counterbalanced equally between Saturday: snooze, Sunday: natural waking and Saturday: natural waking, Sunday: snooze.
15839353|NCT04129580|Device|reSET-O app|The reSET-O app, owned by Pear Therapeutics, Inc., is designed to work as cognitive behavioral therapy, adjunctive to medication assisted treatment, for opioid use disorder. The app provides psychoeducation related to opioid use and dependence, coping skills, and skills to avoid relapse,
15839354|NCT04129567|Other|Humidified oxygen|Delivering humidified oxygen at 15 liters per minute through the nose in a blinded fashion using a nasal cannula.
15839355|NCT04129567|Other|Dry oxygen|Delivering dry oxygen at 15 liters per minute through the nose in a blinded fashion using a nasal cannula.
15839356|NCT04129567|Other|Humidified air|Delivering humidified air at 15 liters per minute through the nose in a blinded fashion using a nasal cannula.
15839357|NCT04129567|Other|Dry air|Delivering dry air at 15 liters per minute through the nose in a blinded fashion using a nasal cannula.
15839365|NCT04129541|Other|Same Day Discharge|Patients in the planned same day discharge (SDD) cohort will be discharged from the PACU once they meet standard discharge criteria.
15839366|NCT04129541|Other|Overnight Hospitalization|Patients in the planned overnight hospitalization (OH) group will be discharged on post-operative day 1 once they meet standard discharge criteria.
15839367|NCT04129528|Drug|CFZ533|First dose is administered via intravenous infusion, subsequent doses are administered subcutaneously.
15839368|NCT04129528|Other|Placebo|Placebo for active drug
15839369|NCT04129515|Device|NovoTTF-200A|•NovoTTF-200A will be applied continuously, with 21 consecutive days defined as a treatment cycle
15839370|NCT04129515|Drug|Pembrolizumab|Pembrolizumab will be administered once every 3 weeks, with 21 consecutive days also defined as a treatment cycle
15839371|NCT04129502|Drug|TAK-788|TAK-788 capsule
15839372|NCT04129502|Drug|Pemetrexed|Pemetrexed IV infusion
15839373|NCT04129502|Drug|Cisplatin|Cisplatin IV infusion
15839374|NCT04129502|Drug|Carboplatin|Carboplatin IV infusion
15839375|NCT04129489|Drug|Cannabidiol|Synthetic Cannabidiol, dissolved in pharmaceutical grade olive oil at a concentration of 5% will be administered orally
15839376|NCT04129476|Behavioral|Cooperative Education Program based on Precede-Proceed Model|The study population is pregnant women in Gonabad city between 30 and 35 weeks of gestation. In the experimental group, the training program was based on the PRECEDE-PROCEDURE model, including training on anatomy and prenatal physiology, prenatal and postnatal care, prenatal and postnatal mental health, as well as prenatal and postnatal events, and Mothers' feelings and attitudes, as well as postpartum problems and strategies will be discussed. The training period is 60 minutes in 4 consecutive sessions. Predisposing, reinforcing and enabling factors inventory, General health questionnaire (GHQ), Edinburgh depression inventory Will be filled Before the intervention, immediately after the intervention and 4 to 6 weeks after the intervention.
15839377|NCT04129463|Device|Subscleral Trabeculectomy (SST) with Iris incarceration|Subscleral Trabeculectomy with Iris Incarceration using iris forceps and scissors
15839379|NCT04129450|Other|Group medical visits with mindfulness-based stress reduction|Eight weekly 90 minute sessions of mindfulness-based stress reduction in group medical visits
15839380|NCT04129450|Other|Usual PCP care|Usual one on one PCP care for chronic lower back pain
15839381|NCT04129437|Drug|Ibuprofen|Weight based ibuprofen dosing
15839382|NCT04129437|Procedure|Osteopathic manipulative treatment|Low velocity osteopathic manipulative treatment
15839383|NCT04129424|Device|Insulin pump (Microtech, Equil®)|Those patients of different types of diabetes mellitus were assigned to different groups, those groups were classified by the time to reach target blood glucose .
15839384|NCT04129411|Device|RFA|Radiofrequency ablation of selectively targeted thyroid nodule to treat papillary thyroid cancer.
15839385|NCT04129398|Drug|Letermovir tablet|A single 240 mg tablet or two 240 mg tablets letermovir administered orally, once daily for 28 weeks
15839386|NCT04129398|Drug|Letermovir IV|IV solution of 240 mg (one vial) or 480 mg (2 vials) letermovir in 250 mL infused over 60 minutes, once daily for 28 weeks
15839387|NCT04129385|Procedure|20 degree Trendelenburg position|The patients in the intervention group will be placed in trendelenburg position postoperatively.
15839388|NCT04129372|Behavioral|New Foods Take Time|New Foods Take Time is a series of 5 classroom lessons focused on increasing children's willingness to try fruits and vegetables.
15839389|NCT04129359|Behavioral|FamilieTrivsel|FamilieTrivsel is a modular internet-based low-cost and brief psychoeducation intervention based on the Robusthed (Resilience) programme (RP). Mentalisation approaches are used to increase resilience and ability to handle the challenges of life. The programme is licence free and can be used with low or high intensity and it can be combined with any other interventions. RP provides simple explanations and tools that can be used to discover, understand and regulate one's own thoughts and feelings by activating mental and physical resources and it provides examples and exercises that may promote communication about mental states between parents and the child. The content has been developed to include video-based training sessions based on different stages of pregnancy and early childrearing. RP appears suitable for use in general practice, where the GP sees young parents regularly and thus can direct patients towards components of the programme when need appears greatest.
15839390|NCT04129359|Other|enhanced care as usual|Structured assessments of maternal mental health, child neurodevelopment and parent-child interaction in routine preventive health care in general practice
15839391|NCT04129346|Behavioral|Fit2ThriveMB App|The Fit2thriveMB app will encourage participants to increase their physical activity. Participants will be provided with educational information on physical activity and effective behavior change strategies for incorporating more physical activity into their daily lives to increase their step count. Participants will be prompted each morning to report the intensity of their symptom burden (0 to 10). Based on their symptom rating and their previous day's step counts, participants will be provided with three different options or levels of goals for that day to either increase or decrease 10-20% or remain constant.
15839392|NCT04129346|Behavioral|Fitbit|The Fitbit measures PA intensity, steps, and heart rate and syncs directly with the smartphone and will automatically sync with the Fit2ThriveMB app and provide Fitbit data to the study team in real-time.
15839393|NCT04129346|Behavioral|Physical Activity Coaching Calls|Participants will receive weekly coaching calls which will: a) provide feedback on the previous week's symptom burden and progress on PA goals; b) review personalized goals and strategies for increasing PA for the next week; c) provide instruction on effective behavioral change techniques
15839394|NCT04129346|Behavioral|Healthy Living Coaching Calls|Participants will receive weekly calls that will cover health and well-being topics for instance: symptom and stress management, healthy diet, hydration, sun safety, sleep hygiene, and meditation.
15839395|NCT04129346|Behavioral|Cancer.net app|Cancer.net app content includes information about health and well-being, treatment guidelines specific to cancer type, symptom tracking and medication tracking
15839396|NCT04129333|Other|Hypnosis|"The hypnosis session :
~Creation of the therapist-patient link
~Choice of a theme and the preferred sensory channel by the patient
~Collection of the theme chosen by the patient
~Orientation in the here and now.
~Induction
~Realization of the gesture and hypnosis
~At the end of the procedure, reassociation of the patient in the here and now"
15839397|NCT04129333|Other|No hypnosis|No hypnosis
15839398|NCT04129320|Biological|enoblituzumab|anti-B7-H3 antibody
15839399|NCT04129320|Biological|MGA012|anti-PD-1 antibody
15839400|NCT04129320|Biological|MGD013|PD-1 X LAG-3 bispecific DART protein
15839401|NCT04129307|Behavioral|Motor imagery|This group will perform motor imagery training in combination with physical practice on motor learning of different motor tasks.
15839402|NCT04129307|Behavioral|Double time motor imagery|This group will perform motor imagery training by doubling the intervention time to the motor imagery group in combination with physical practice on motor learning of various motor tasks.
15839403|NCT04129307|Behavioral|Action observation|This group will perform action observation training in combination with physical practice on motor learning of various motor tasks.
15839404|NCT04129294|Drug|NS-089/NCNP-02|"NS-089/NCNP-02 for Infusion is packaged as 50 mg/mL with 3 mL per vial. Study dosages will be infused over a 1 hour period at the following dose levels.
~[Part 1] NS-089/NCNP-02 is administered at dose levels 1 and 3 in Cohort 1 and at dose levels 2 and 4 in Cohort 2.
~Dose level 1: 1.62 mg/kg once weekly for 2 weeks; Dose level 2: 10 mg/kg once weekly for 2 weeks; Dose level 3: 40 mg/kg once weekly for 2 weeks; Dose level 4: 80 mg/kg once weekly for 2 weeks [Part 2] Based on the results from Part 1, two dosages are selected as study dosages in Part 2. Each selected dose are administered once a week for 24 weeks."
15839405|NCT04129281|Procedure|Surgery|Surgery acconding to clinical practice
15839406|NCT04129268|Other|Cycle ergometry exercise at 60% VO2max|Participants visit the lab on four occasions to complete (i) no exercise; (ii) 175kcal exercise; (iii) 350kcal exercise; (iv) or 700kcal exercise (randomised).
15839407|NCT04129255|Drug|Octreotide Acetate|administration every 28 days
15839408|NCT04129242|Device|Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) + Task Specifc Training|A closed-loop taVNS system that delivers taVNS with upper-limb rehabilitation training in a chronic stroke population.
15839443|NCT04128943|Other|symptom questionnaire|"A weekly filled in symptom questionnaire for reported symptoms of AA and/or PNH (yes/no, grade, date). Grading according to current grading systems (Common Terminology Criteria for Adverse Events,CTCAE).
~Data collection and processing via the ePRO application by Kaiku Health Ltd"
15839409|NCT04129229|Device|LinguaFlex Tongue Retractor (LTR)|The LinguaFlex Tongue Retractor (LTR) is a small, flexible, implanted tongue retaining device that prevents the backward movement of the tongue during sleep. The LTR's flexible shaft and a nubbed tether passes through the center of the tongue beneath the tongue blade (frenulum area) and connects to a disc (head) that rests on the external surface of the tongue base mucosa. Underneath the tongue, on the external surface of the frenulum, a small anchor secures the shaft that can be adjusted to tension the LTR to maximize therapeutic effect and maintain comfort.
15839410|NCT04129216|Drug|Tamoxifen Citrate|10mg administered daily. Patients take this drug for 2-6 weeks
15839411|NCT04129216|Drug|Letrozole|2.5mg is administered daily. Patients take this drug for 2-6 weeks
15839412|NCT04129216|Drug|Exemestane|25mg is administered daily. Patients take this drug for 2-6 weeks.
15839413|NCT04129216|Diagnostic Test|Blueprint|studies the genomics of the tumor and tumor behavior
15839414|NCT04129216|Diagnostic Test|Mammaprint|studies the genomics of the tumor
15839415|NCT04129203|Device|Versi Retriever thrombectomy|Mechanical thrombectomy using Versi Retriever
15839416|NCT04129190|Biological|Glucose|Oral Intake of Glucose
15839417|NCT04129177|Other|Implementation of a bundle of surgical infection preventive measures|A bundle of six preventative measures is recommended to the VINCat hospitals. Bundle measures were: systemic and oral antibiotic prophylaxis, mechanical bowel preparation (MBP), laparoscopic surgery, maintenance of normothermia, and the use of a double-ring wound retractor.
15839418|NCT04129164|Drug|VIB4920|Intravenous Dose 1.
15839419|NCT04129164|Drug|Placebo|Intravenous dose matched to VIB4920.
15839420|NCT04129151|Drug|Palbociclib|Oral, per protocol pre determined dosage, once a day for 21 days
15839421|NCT04129151|Drug|Ganitumab|-Intravenous, per protocol predetermined dosage, twice per cycle
15839422|NCT04129138|Other|Survey Administration|Complete survey
15839423|NCT04129125|Device|Zoom Reperfusion System|Thrombectomy
15839424|NCT04129112|Drug|We do not modify the normale general anesthesia delivery. We note the concentration of propofol at the effector site of body movementsand awakening|Propofol in our hospital is routinely delivered by Targeted Controlled Infusion (TCI) pumps. We note the concentration of propofol at the effector site of body movements and awakening
15839425|NCT04129099|Biological|GC022F|GC022F is the CAR-T cell immunotherapy targeted CD19 and CD22. The subjects will receive GC022F as one dose. The dosage ranges from 6×10^4 to 1.5×10^5 CAR+T/Kg.
15839426|NCT04129086|Drug|Ketamine plus usual care|Bolus of .35 mg/kg Infusion start @ 0.15 mg/kg/hr; titrate range is 0.1 - 0.25 mg/kg/hr for 24 to 48 hours after admission and each subsequent major surgery plus multi-modal pain therapy considered as standard of care. Standard of care medications include Acetaminophen 1000 mg po q6 hours, Naproxen 500 mg po q12 hours, Gabapentin 300 mg po q8 hours and Lidocaine patch q 12 hours.
15839427|NCT04129086|Drug|Usual Care|Standard of care medications include Acetaminophen 1000 mg po q6 hours, Naproxen 500 mg po q12 hours, Gabapentin 300 mg po q8 hours and Lidocaine patch q 12 hours.
15839428|NCT04129073|Other|Intensive care treatment|Intensive care treatment; Utilization of neuroprognostication tools
15839429|NCT04129060|Drug|Cholinergic antagonist|The cholinergic antagonist drug mecamylamine will be administered as a a 20 mg oral pill and matching placebo
15839430|NCT04129047|Drug|Omnichroma (one shade universal) composite by Tokuyama|Omnichroma is a single shade composite that is intended to have a color blending potential. It eliminates the shade matching procedures and makes it easier to avoid individual errors in shade matching in composite restorations.
15839431|NCT04129047|Drug|A microhybrid composite Z250 (3 M ESPE, St. Paul, MN, USA|a multiple shade universal composite that needs prior shade selection procedure
15839432|NCT04129034|Device|Neurolyser XR|Non-Invasive Thermal Ablation of the Medial Branch Nerves
15839433|NCT04129021|Device|High-resolution retinal imaging through adaptive optics|The protocol consists of performing retinal imaging using full-field optical coherence tomography. The participant is asked to put his forehead against the temple supports and his chin on a chin rest. The subject will be asked to fix a test pattern in the form of a cross. The pattern is positioned according to the desired eccentricity with respect to the fovea. The actual acquisition lasts a few seconds, possibly repeated to cover the field of the desired eye. The acquisition protocol depends on the subjects, their pathology and the system used; the area examined will be modified on a case by case basis. The total duration of each exam can be estimated at less than half an hour, with frequent breaks.
15839434|NCT04129021|Device|High-resolution retinal imaging through holographic systems|The protocol consists of performing retinal imaging using a laser Doppler holography. For each system, the participant is asked to put his forehead against the temple supports and his chin on a chin rest. The subject will be asked to fix a test pattern in the form of a cross. The pattern is positioned according to the desired eccentricity with respect to the fovea. The actual acquisition lasts a few seconds, possibly repeated to cover the field of the desired eye. The acquisition protocol depends on the subjects, their pathology and the system used; the area examined will be modified on a case by case basis. The total duration of each exam can be estimated at less than half an hour, with frequent breaks.
15839435|NCT04129008|Drug|Indobufen and aspirin mimetic|Day 1 to 84±7: The first time: indobufen 100mg + aspirin mimetic; The second time: indobufen 100mg
15839436|NCT04129008|Drug|Aspirin and indobufen mimetic|Day 1 to 84±7: The first time : aspirin 100mg+ indobufen mimetic; The second time: indobufen mimetic
15839437|NCT04128995|Procedure|Bariatric Surgery|Vertical Sleeve Gastrectomy and Advanced Medical Therapy that could include metformin, GLP-1 agonist, SGLT-2 inhibitor, or basal insulin
15839438|NCT04128995|Drug|Advanced Medical Therapy|Use of combination medical therapy that could include metformin, GLP-1 agonist, SGLT-2 inhibitor, or basal insulin
15839439|NCT04128982|Procedure|mobilization of the larynx|Check the intubation conditions during laryngoscopy without external mobilization of the larynx, with Sellick manoeuvre or with low paratracheal esophagal compression in 2 groups: patient in dorsal decubitus or Rapid Airway Management Positioner.
15839440|NCT04128969|Dietary Supplement|CS+|Oral carnitine supplementation
15839441|NCT04128969|Dietary Supplement|CS-|Placebo
15839442|NCT04128956|Drug|Aspirin 100mg|Aspirin® cardio (CH) or Aspirin® protect (DE, AT) Film coated tablets Acetylsalicylic acid 100 mg Once daily oral intake for 6 months
15839573|NCT04127851|Drug|TJO-018|TJO-018 / one drop / 6 times daily in both eyes
15839444|NCT04128943|Other|recording of vital signs|Record function for vital parameters (blood pressure, temperature and pulse); Data collection and processing via the ePRO application by Kaiku Health Ltd
15839445|NCT04128943|Other|European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30 questionnaire|The EORTC QLQ-C30 incorporates nine multi-item scales: five functional scales (Physical, Role, Cognitive, Emotional and Social Functioning); three symptom scales (Fatigue, Pain and Nausea/Vomiting); and a Global Health Status/QoL scale. Six single item scales are also included (Dyspnoea, Insomnia, Appetite Loss, Constipation, Diarrhoea and Financial Difficulties). All of the scales range in score from 0 to 100. A high score for a functional scale represents a high/healthy level of functioning whereas a high score for a symptom scale or item represents a high level of symptomatology or problems.
15839446|NCT04128943|Other|interview|Interview with the patients and responsible medical team by phone or during hospital visit about functional problems regarding the application (duration: 15-30 min) to avoid incorrect use of the application, at week 3 and month 3 and month 6
15839447|NCT04128930|Device|PAP titration at home|Fixed CPAP or APAP titration at home
15839448|NCT04128917|Drug|Tegoprazan|Tegoprazan 50 mg or 100 mg/Clarithromycin/Amoxicillin BID peroral
15839449|NCT04128917|Drug|RAPAE01|RAPAE01/Clarithromycin/Amoxicillin BID peroral
15839450|NCT04128904|Procedure|IVF|"Fertilisation with standard in vitro fertilisation (IVF). For details please see Project Description."
15839451|NCT04128904|Procedure|ICSI|"Fertilisation with intracytoplasmic sperm injection (ICSI). For details please see Project Description."
15839452|NCT04128891|Drug|Sacubitril-Valsartan|Cardiomagnetic Resonance Imaging
15839453|NCT04128878|Drug|Sotalol|The primary goal of the study will be to evaluate the change in endothelial function seen after initiating anti-arrhythmic medical therapy. Testing will be performed at baseline prior to the 1st dose of anti-arrhythmic therapy and again 1-3 months later at outpatient follow-up visit. We will record the resting flow (RF), biological zero (BZ) and peak flow (PF) as perfusion units (PU). Specifically, we will assess arterial stiffness and vasodilation in response to acetylcholine iontophoresis, nitroprusside iontophoresis, local thermal hyperemia and reactive hyperemia. Laser speckle contrast imaging will be employed to evaluate the microvasculature. SphygmoCor (arterial tonometry) will be used to assess macrovasculature.
15839454|NCT04128878|Drug|Dofetilide|Same as described above with sotalol.
15839455|NCT04128852|Device|MagnetOs Putty|MagnetOs Putty has a CE-mark (2115660CE01) as well as FDA 510(k) clearance (K171563/K181958).
15839456|NCT04128826|Other|Resistance Training|Using the cable machine, shoulders will be flexed to 180° for both (PROM & FROM) groups throughout the training; FROM would train with full elbow extension (complete elbow flexion to extension) whereas PROM will train with partial elbow extension from 60° to 110°. A total of 8 sessions, 2 sessions/week for 4 weeks will be carried out by both groups. CON group will not participate in training protocol.
15839457|NCT04128813|Device|Vertical whole body vibration|A neuromuscular treatment using two types of whole body vibration platforms, a rotational and a vertical platform.
15839458|NCT04128800|Drug|Apatinib S-1|apatinib 250 mg PO qd; S-1 40 mg PO in the morning and 60 mg PO in the evening; 14 days in combination, 21 days in a cycle.
15839459|NCT04128787|Drug|AG881 Formulation 1|AG881 uncoated tablets
15839460|NCT04128787|Drug|AG881 Formulation 2|AG881 film-coated tablets
15839461|NCT04128787|Drug|Omeprazole|Omeprazole capsules
15839463|NCT04128761|Behavioral|Scarcity Narrative|Participants are presented with a hypothetical scarcity narrative and asked to read and consider the scenario.
15839464|NCT04128761|Behavioral|Neutral Narrative|Participants are presented with a hypothetical neutral narrative and asked to read and consider the scenario.
15839465|NCT04128748|Drug|Liposome-encapsulated Daunorubicin-Cytarabine|Given IV
15839466|NCT04128748|Drug|Quizartinib|Given PO
15839467|NCT04128722|Drug|Sirolimus Oral Liquid Product 1mg/mL|0.5 mL to 1 mL according to the size of the lesion, once daily, on lingual microcystic lymphatic malformation
15839468|NCT04128709|Device|Urodynamics Testing|The non-invasive device connects to the end of urinary catheter that the patient uses for routine daily catheterization. Once urine flows into the device the patient presses a single button in order to obtain a pressure measurement which is recorded and stored in the device along with the time and date. The measurement(s) can later be transmitted wirelessly to a smart phone that contains an app for the device.
15839469|NCT04128696|Drug|feladilimab|feladilimab is available as an intravenous infusion.
15839470|NCT04128696|Drug|Pembrolizumab|Pembrolizumab is available as an intravenous infusion.
15839471|NCT04128696|Drug|Placebo|Placebo is available as an intravenous infusion.
15839472|NCT04128683|Drug|amisulpride|Dopamine D2 antagonist to test how it affects brain response and behavior to prediction error and reversal tasks during functional magnetic resonance imaging (fMRI).
15839473|NCT04128683|Drug|bromocriptine|Dopamine D2 receptor agonist test how it affects brain response and behavior to prediction error and reversal tasks during functional magnetic resonance imaging (fMRI).
15839474|NCT04128670|Device|Kinesiotape|Tape will be applied to the biceps muscle of the nondominant arm from approximately the shoulder to the elbow for up to 72 hours. For the KT group taping will be applied with a lymphatic application method according to the guidelines recommended by Kenzo Kase. This type of application is known to improve blood and lymphatic circulation which enhances the removal of metabolic products. It is recommended that the application of the tape for lymphatic correction be applied for 24-72 hours. The tape will be applied with a tension of 10-20%.
15839475|NCT04128657|Diagnostic Test|MA_LARS|Validation of the MA_LARS and MA_Wexner
15839476|NCT04128644|Behavioral|Thoughts & health|12 sessions of Thoughts & Health. Baseline questionaires and follow up assessments
15839477|NCT04128644|Other|Treatment as Usual|Baseline questionnaires and follow up assessments, intervention as usual, Student Health
15839478|NCT04128618|Device|CyMedica e-vive NMES|Neuromuscular Electrical Stimulation (NMES) therapy
15839479|NCT04128605|Procedure|Suprascapular nerve block (SSNB)|"SSNB is performed using ultrasound guidance by skilled interventionist under ultrasound guidance.
~Skin area at posterior shoulder is first infiltrated with Lidocaine 1%. Then, a mixture of 5 mls of Bupivacaine, 5 mls Lidocaine 1% and 10 mls of saline are injected at posterior shoulder towards suprascapular notch surrounding suprascapular nerve."
15839480|NCT04128605|Procedure|Intraarticular shoulder steroid injection (IAS)|"IAS is performed using ultrasound guidance by skilled interventionist under ultrasound guidance.
~Skin area at posterior shoulder is first infiltrated with Lidocaine 1%. IAS is performed by injecting 40 mg of Triamcenolone Acetonide along with 2 ml of Lidocaine 1% into glenohumeral articular space"
15839481|NCT04128592|Device|diagnosing noisy breathing in infants and toddlers|breath sampling and nasal mucus sampling to analyze biomarkers and breath sound analysis to diagnose noisy breathing.
15839482|NCT04128579|Drug|Itolizumab [Bmab 600]|EQ001
15839483|NCT04128566|Procedure|walking stress test|walk for 30 minutes on a treadmill with either one of the three loading conditions (reduced load = 80% Bodyweight (BW), normal load = 100% BW, increased load = 120% BW). The order of experimental condition will be applied in randomized order determined by block randomization, and the same self-selected walking speed will be used for all conditions.
15839484|NCT04128553|Behavioral|Intervention motivational interview group|Motivational interviewing (MI) a client-centered, goal-oriented method for enhancing intrinsic motivation to change by exploring and resolving ambivalence. Motivational interviewing is underpinned by a series of principles that emphasise a collaborative therapeutic relationship in which the autonomy of the patient is respected and the patient's intrinsic resources for change are elicited by the therapist.
15839485|NCT04128540|Drug|Fentanyl|fentanyl infusion at a dose of (1 μg/kg/hour) after induction of anesthesia and to be continued all through the whole operation.rescue analgesia by a bolus of (Fentanyl 1mcg/kg) will be given to the patients in either group, if either systolic blood pressure or heart rate increased more than 20% of the baseline readings.
15839486|NCT04128540|Procedure|Erector spinae plane block|"ultrasound guided erector spinae plane block by injecting 0.4ml/kg (1:1 solution of bupivacaine 0.25% and lidocaine 1%). This will be performed at the same side of the planned thoracotomy under strict aseptic precautions.A high frequency 12 MHz linear ultrasound transducer will be placed in a longitudinal orientation 3 cm lateral to the T3 spinous process corresponding to the T2 transverse process.
~Three muscles; trapezius, rhomboids major, and erector spinae will be identified superior to the hyperechoic transverse process.
~Using in-plane approach a 25 G needle will be inserted in caudal-cephalic direction, until the tip is deep to erector spinae muscle.
~Correct needle tip location will be confirmed by injecting 3 mL of normal saline and visualizing the linear LA spread in the fascial plane between the erector spinae muscle and the transverse process.."
15839487|NCT04128527|Device|Placement of laryngeal mask|All participants are experienced in placement of laryngeal masks and placement will be performed according to standard clinical practice.
15839488|NCT04128514|Device|Panoptix Toric|Cataract surgery and IOL implantation
15839489|NCT04128501|Drug|Azacitidine|Given SC
15839490|NCT04128501|Drug|Venetoclax|Given PO
15839491|NCT04128488|Other|Abdominal MR Imaging|Imaging to evaluate visceral adipose tissue and hepatic lipid content
15839492|NCT04128488|Other|Cardiac MRI/MRS|Imaging to evaluate cardiac function and structure
15839493|NCT04128488|Other|Oral Glucose Tolerance Testing|Blood testing to evaluate changes in glucose and insulin in response to oral glucose load
15839494|NCT04128488|Other|Whole Body, Lumbar Spine, and Hip DEXA Imaging|Imaging to evaluate fat and lean body mass as well as bone mineral density
15839495|NCT04128475|Other|N/A - observational study.|N/A - observational study.
15839496|NCT04128462|Drug|MNK-6105|L-Ornithine Phenylacetate for IV infusion
15839497|NCT04128462|Drug|Placebo|Matching placebo for IV infusion
15839498|NCT04128462|Drug|Standard of Care|Lactulose ± rifaximin as SoC treatment for overt HE should be administered per the clinical judgement of the investigator and usual institutional practice.
15839499|NCT04128449|Dietary Supplement|docosahexaenoic acid|5 dragees every 24 hours
15839500|NCT04128449|Dietary Supplement|Placebo|5 dragees every 24 hours
15839501|NCT04128436|Other|Taking blood samples for analyzing progesterone levels|As part of standard in vitro fertilization treatment, Crinone gel will be used starting the next morning following the oocyte pick-up (OPU) as a luteal phase support. On the trigger day, on the day OPU+2/3 (early luteal phase) and on the embryo transfer day (OPU+5, mid luteal phase) blood samples will be taken from patients for evaluating the progesterone levels. Blood samples will be collected at the 6th hour following the morning dose of vaginal progesterone gel. No other intervention will be done to the patients.
15839503|NCT04128397|Device|traditional stimulation site transcranial magnetic stimulation（TMS）|before TMS treatment , do fMRI to confirm stimulation site
15839504|NCT04128397|Device|precise stimulation site TMS|The stimulation site include left supplementary motor area, right supplementary motor area, left primary motor area, right primary motor area , left superior parietal lobule, right superior parietal lobule.
15839505|NCT04128384|Diagnostic Test|Limited electrophysiologic study including measurements of HV- and AH-intervals pre- and post-TAVR|For the purpose of obtaining intracardiac measurements, the quadripolar diagnostic catheter used as temporary pacemaker wire (5F, Woven, Boston Scientific) during TAVR was retracted from the apex and positioned at the His bundle to measure HV- and AH-intervals.
15839506|NCT04128371|Biological|Nucala (mepolizumab)|Mepolizumab is a fully humanized monoclonal antibody (IgG1, kappa mAb) supplied as 100 mg of lyophilized powder in sterile, single-dose vials. Mepolizumab 100 mg vials will be reconstituted with 1.2 ml sterile water for injection (according to the product labeling) and secondarily diluted in 100-250 ml of 0.9% normal saline (NaCl) for infusion (to a final concentration of 0.3-7.5 mg/ml).
15839507|NCT04128358|Diagnostic Test|Serological assay for blood born viral hepatitis|Qualitative PCR for patients with hepatitis C antibody positive
15839508|NCT04128358|Diagnostic Test|Quantitative microbiological test for HCV|Quantitative PCR in those with proven HCV infection
15839509|NCT04128345|Device|Use of navigation system|Feasibility assessment of using an integrated navigation system incorporating advanced diffusion MRI, volumentric tumour representation and intraoperative ultrasound
15839510|NCT04128332|Radiation|Pre-operative stereotactic ablative body radiotherapy|Stereotactic ablative body radiotherapy is a highly focused radiation treatment that gives an intense dose of radiation concentrated on a tumour, while limiting the dose to the surrounding tissues.
15839511|NCT04128319|Drug|T-Guard|Patients will receive 4 doses of T-Guard treatment, administered intravenously as four 4-hour infusions at least two calendar days (no less than 40 hours) apart. Each dose consists of 4 mg/m^2 Body Surface Area (BSA).
15839512|NCT04128306|Behavioral|Behavioral task|In the task, participants will see an object approaching toward them. During its movement, the object disappears, and the participants have to press a button to indicate when they estimate the object to contact with them. The motion parameters of the ball will be varied. The pre and post-surgery phases will test the participants in a long duration version of the task, approximately 30 minutes. The per surgery phase will be made of a 5 minutes version of the task, and the participants will receive a direct cortical stimulation for 4 seconds, at an intensity of 1 to 10 milliampere (mA), in the premotor ventral area, or posterior parietal cortex or somesthetic associative areas.
15839513|NCT04128306|Procedure|Awake surgery|"The patient is first anesthetized for opening the scalp and skull, then awake. During this waking phase, the surgeon passes a few quick and simple tests to the patient, visual (for example, line bisection), language (for example, repeating a list of words) etc. While doing this task, the neurosurgeon disrupts the functioning of certain brain regions by direct electrical stimulation of the cortex in order to identify the regions whose dysfunction will have an impact on the current task.
~During the operation, the areas involved in the construction of the peri-personal space will be stimulated by direct electrical stimulation, for a duration of 4 seconds at an intensity of 1 to 10 mA. These areas are:
~Ventral premotor cortex (with the exception of the primary motor cortex controlling the dominant hand, so as not to interfere with the motor response of the patient)
~Posterior parietal cortex
~Associative somesthetic areas"
15839514|NCT04128306|Other|Neurological assessment|The Mini Mental State Evaluation, which generally assesses the cognitive state of an individual through his 6 subtests testing both working memory, episodic and semantic praxies as well as spatio-temporal orientation capacity.
15839515|NCT04128306|Other|Neurological assessment|The Wechsler Adult Intelligence Scale was selected for two of its subtests: The Subtest Codes checking the processing of information, visuo-constructive abilities but also attention. The subtest Cubes evaluates the capacities of visuospatial and constructive organizations as well as the referencing of the space in relation to the subject.
15839516|NCT04128306|Other|Neurological assessment|The State-Trait Anxiety Inventory, consisting of two self-administered questionnaires: Questionnaire A, measuring the state of anxiety of the person on the present moment and B measuring anxiety as a character trait of the person
15839517|NCT04128306|Other|Neurological assessment|The Verbal Fluences test, in its oral version. Categorial and lexical fluences make it possible to quickly realize a possible lack of the word of the person as well as disturbances of working memory or the capacity of inhibition.
15839518|NCT04128306|Other|Neurological assessment|The board of the Corsi cubes that evaluates the non-verbal visual-spatial working memory of the participants with a reminder location that tests the visuo-spatial notebook and a reminder to who tests the central administrator of the working memory.
15839519|NCT04128306|Other|Neurological assessment|The neurocognitive naming test was chosen to verify correct access to both semantic memory and lexicon, as well as to test the early visual process of image processing necessary for our task.
15839520|NCT04128306|Other|Neurological assessment|Benton lines are commonly used to determine possible deficits in the localization of isolated objects or judgment of line direction.
15839521|NCT04128306|Other|Neurological assessment|The patient will finally pass a depression assessment test, answering Beck's questionnaire.
15839522|NCT04128293|Drug|GSK3640254 Tablet|GSK3640254 tablets will contain mesylate salt with a unit dose of 100 mg (2x100 mg) and will be administered orally.
15839523|NCT04128293|Drug|GSK3640254 Capsule|GSK3640254 capsules will contain mesylate salt with a unit dose of 100 mg (2x100 mg) and will be administered orally.
15839524|NCT04128280|Procedure|TUDP|a surgery: transurethral dilation of prostate with a columnar balloon
15839525|NCT04128280|Procedure|TUIB|a surgery: transurethral incision of bladder neck
15839526|NCT04128267|Device|IPC-1000|Delivers pressure to thumbnail for five seconds at a time
15839527|NCT04128267|Device|Magnetic resonance imaging|Scan of brain using Magnetic resonance imaging
15839528|NCT04128267|Other|Correlative Studies|Administration of questionnaires via computer
15839529|NCT04128254|Drug|Apixaban Oral Tablet|Apixaban is a kind of oral anticoagulant drugs used to prevent venous thromboembolism
15839530|NCT04128228|Behavioral|8-week outpatient treatment|All patients will receive outpatient treatment for alcohol use disorder for 8 weeks. There will be two appointments each week for individual therapy sessions using cognitive behavioral therapy combined with stress management.
15839531|NCT04128215|Behavioral|Control Period|Subjects will complete an 8-week control period of normal lifestyle, followed by the 8-week exercise period.
15839532|NCT04128215|Behavioral|Exercise Period|Subjects will complete an 8-week non-weight-bearing all-extremity high intensity interval training (NWA-HIIT). NWA-HIIT will consist of 4x4-min bouts at 90% of maximal heart rate (HRmax) interspersed by 3x3-min bouts at 70% of HRmax. A 10-min warm-up and 5-minute cool-down at 70% of HRmax will be included.
15839533|NCT04128202|Behavioral|Sunnyside|The Sunnyside intervention is an online intervention (an interactive website with didactic material and interactive tools) targeting skills to manage mood during and after pregnancy. The Sunnyside intervention will consist of 6weeks of online lessons during pregnancy and booster sessions at 2 weeks, 4 weeks, and 6 weeks postpartum. Each lesson takes approximately 10 minutes to complete.
15839534|NCT04128202|Behavioral|Sunnyside Plus|Sunnyside Plus will build upon the Sunnyside intervention, plus include additional education and support to promote breastfeeding. Breastfeeding education and skills will be provided during the 6weeks of online lessons during pregnancy; each lesson takes approximately 10 minutes to complete. Breastfeeding support will continue through 6 weeks postpartum. This postpartum support will involve weekly online lessons(each taking approximately 10 minutes to complete), text support messages(3 sent during weeks 1 and 2, 2 sent during weeks 3 and 4, 1 sent during weeks 5 and 6), and video support calls with a Lactation Educator (LE)provided on an as-needed basis(exception: at least 1 video call is required during both week 1 postpartum and week 2 postpartum).
15839535|NCT04128189|Biological|Shingrix|Both arms receive standard 2 doses of Shingrix. Transplanted subjects may receive 3rd dose.
15839536|NCT04128176|Drug|Rituximab combined with Omalizumab|Rituximab 1000 mg will be administered by IV infusion 6 months after the patient's initial cycle of rituximab (received in the screening period).Omalizumab (300 mg) will be administered subcutaneously every 2 weeks starting on Day 1 until week 24 (primary endpoint) and again until week 52 (secondary endpoint).
15840203|NCT04122287|Drug|tinidazole|tinidazole-tetracycline-containing quadruple regimens
15839537|NCT04128163|Drug|QL1206|"subcutaneous injection of 60 mg（60mg:1ml）, Q6M, twice for one year.
~Dietary Supplement: Elemental Calcium Oral, at least 500 mg Dietary Supplement: Vitamin D Oral, 1000 IU"
15839538|NCT04128163|Drug|Placebos|"subcutaneous injection of（1ml）, Q6M, twice for one year.
~Dietary Supplement: Elemental Calcium Oral, at least 500 mg Dietary Supplement: Vitamin D Oral, 1000 IU"
15839539|NCT04128137|Drug|Fludrocortisone|50 µg/day during one week then augmentation of 50 µg each weeks until a maximum dose of 200 µg/day. And a maintenance phase of 4 weeks at a stable dose
15839540|NCT04128137|Other|Placebo|50 µg/day during one week then augmentation of 50 µg each weeks until a maximum dose of 200 µg/day. And a maintenance phase of 4 weeks at a stable dose
15839541|NCT04128124|Other|processing signals of airway pressure and airway flow to calculate entropy|processing of previously recorded data from a dedicated software of airway pressure and airway flow in order to calculate entropy
15839542|NCT04128098|Other|Evaluation|"Functional tests: 400-meter walking test, 200-meter brisk walking test, Sorensen test, Shirado test, measurement of maximum isometric force of extensors/back flexors.
~3D analysis of locomotion and posture
~Test of the flexion-relaxation phenomenon of the lumbar erector muscles"
15839543|NCT04128098|Other|Questionnaires|Self-questionnaires: Oswestry, Québec, SF-12, VAS pain, HAD, pain dramatization questionnaire, physical activity questionnaires, VAS and GPE satisfaction, FABQ, GPE functional status and EPICES score.
15839544|NCT04128098|Other|Rehabilitation care program|"Personalized global exercises (aerobics) on ergometers
~Muscle strengthening with resistance
~Balneotherapy
~Learning health skills related to their condition (therapeutic education)
~Personal and group motivational interviews
~Nutritional advice
~Relaxation session"
15839545|NCT04128085|Drug|TQB3804|A kind of tyrosine kinase inhibitor.
15839546|NCT04128072|Drug|Mogamulizumab|• Patients will receive mogamulizumab 1.0 mg/kg IV over at least 1 hour on Days 1, 8, 15 and 22 of the first 28 day treatment cycle (C1) and on Days 1 and 15 of subsequent 28 day cycle (C2).
15839547|NCT04128072|Radiation|Total Skin Electron Beam Therapy (TSEB)|"After completion of C2, patients will be administered TSEB at a dose of 12 Gy in 8 fractions (4 fractions per week). TSEB will start 28 days (window of + 7 days) after mogamulizumab (C2 D1).
~In case of toxicity from mogamulizumab, the maximum delay permitted for the start of TSEB is 2 weeks.
~If recovery to at least grade 1 from toxicity exceeds the 2 weeks interval, please contact the medical monitor.
~Mogamulizumab is stopped during TSEB administration."
15839548|NCT04128072|Drug|Mogamulizumab (subsequent cycles post TSEB)|"• Mogamulizumab will be restarted at a dose of 1.0 mg/kg IV on Days 1, 8, 15 and 22 for cycle 3. Subsequent cycles will be administered as for C2.
~Treatment with mogamulizumab will be continued until disease progression (PD) or the occurrence of another withdrawal criterion."
15839549|NCT04128059|Drug|BVRS-GamVac-Combi|"BVRS-GamVac-Combi, a combined vector vaccine for the prevention of Middle East respiratory syndrome, lyophilisate for the preparation of a solution for intramuscular administration"
15839550|NCT04128059|Other|placebo|placebo
15839551|NCT04128046|Procedure|PRFM injection|Using a 27-gauge microcannula, a total of 4 mL of PRFM was injected intradermally into the mid-cheek and NLF (2 mL for each site) on one side of the face.
15839552|NCT04128046|Procedure|Saline injection|Using a 27-gauge microcannula, a total of 4 mL of saline was injected intradermally into the mid-cheek and NLF (2 mL for each site) on the contralateral side of the face.
15839553|NCT04128033|Other|Puncture of the RP6 point|"Puncture of RP6 San Yin Jiao point, located just behind the posterior edge of the tibia 3 cm above the end of the inner malleolus."
15839554|NCT04128033|Other|Puncture of the placebo point|"Puncture of a placebo point outside the meridian, with no effect"
15839555|NCT04128020|Drug|Nivolumab|Nivolumab
15839556|NCT04128020|Drug|Azacitidine|Azacitidine
15839557|NCT04128007|Drug|ARQ-154 foam 0.3%|experimental
15839558|NCT04128007|Drug|ARQ-154 vehicle foam|experimental
15839559|NCT04127994|Other|Comparing 3 versus 6 meals in type 2 diabetes patients|We will compare a 3 meals regimen versus a 6 meal regimen in patients with type 2 diabetes and overweight or obesity, to analyze which of the regimens have better outcomes in glycemic variability
15839560|NCT04127981|Diagnostic Test|18F-FDG PET + Dexa Scan|18F-FDG PET will be compared with Dexa Scan result within and between arms.
15839561|NCT04127968|Drug|Vitamin A|Children in intervention group will receive 50,000 IU vitamin A after being randomized.
15839562|NCT04127968|Drug|Oil|Children in control group will receive equal volume of oil.
15839563|NCT04127955|Other|Theory of Planned Behavior based Physical Activity Intervention|"Health education: The first component of intervention consisted of one session 30 minutes educational lesson relation to physical activity.
~Group walking: The format of the 15-minute group walking session included 5 minutes of warm-up, 5 minute moderate intensity walking, 5 minute cool-down.
~Counseling (individually tailored): The nurse received training about motivational interview technique for use in their physical activity counseling with participants. Using pedometers and step diary to set goals and monitor progress.
~Pedometer: pedometer will be used objective physical activity assessment. Measurement of physical activity levels, wearing a pedometer (Omron HJ321E) on a belt over one hip, all day for 7 days, removing for bathing and sleeping. A diary is also provided to record step count. The pedometer will be used for baseline and outcome measurement of step-counts for the trial."
15839564|NCT04127942|Procedure|platelet-rich plasma injection therapy of TMD|The administer injected 1cc PRP in the superior temporomandibular disk joint space by ultrasound guidance.
15839565|NCT04127929|Other|Restoration of cavities using glass carbomer material (GCP Dental)|Detection of caries then restoration of cavities
15839566|NCT04127929|Other|Restoration of cavities using nanocomposite resin (Tokuyama Estelite Posterior)|Detection of caries then restoration of cavities
15839567|NCT04127916|Drug|Bendamustine|To investigate the efficacy and safety of bendamustine plus rituximab in patients with mantle cell lymphoma.
15839568|NCT04127903|Other|the Length of Right Main Stem Bronchus|The distance between the carina and the proximal margin of the right upper lobe orifice on the coronal plane measured by computerised tomography
15839569|NCT04127890|Dietary Supplement|ELO Water|oxygen-enriched water
15839570|NCT04127890|Dietary Supplement|Placebo drinking water|bottled drinking water
15839571|NCT04127877|Device|NICAS|Electric regional bio impedance device
15839572|NCT04127864|Procedure|Colorectal cancer surgery|All participants will undergo surgery for colorectal cancer.
15839575|NCT04127851|Drug|TJO-018 + Cyclosporine Ophthalmic Emulsion 0.05%|TJO-018 one drop 6 times daily & Cyclosporine one drop twice daily in both eyes
15839576|NCT04127838|Behavioral|Low Vision Occupational Therapy|Occupational therapy may include methods to effectively modify environments (such as addition of task lighting), training in the use of assistive technology (such as voice activated devices), teaching new skills (such as sensory substitution) and prevention of accidents and injury (such as home safety modifications).
15839577|NCT04127825|Procedure|Acute Normovolemic Hemodilution (ANH)|Acute normovolemic hemodilution (ANH) is a method of blood conservation used to reduce the amount of donor blood transfused. It involves removing blood from appropriate patients immediately after the induction of anesthesia, replacing the volume lost with colloids (e.g. 5% albumin), then storing and returning this blood to the patient at the completion of the surgical procedures.
15839578|NCT04127812|Behavioral|Savor the Flavor|A series of five interactive classroom lessons focused on mindfulness in eating.
15839579|NCT04127799|Other|Hospital-Community-Family-Care Management Platform Online|Subjects with Hospital-Community-Family-Care Management Platform online and those with the clinic follow up. In the program, participants were educated on the use of smart health-tracking devices and mobile application (APP) to collect and upload comprehensive data elements related to the risk of AF self-care management. They were also instructed to send text messages, view notifications, and receive individualized guidance on the mobile APP. The general practitioners viewed index of each participant on mobile APP and provided primary care periodically, and cardiologists in regional central hospital offered remote guidance and management if necessary. Outcomes assessed included accomplishments of the program, usability and satisfaction, engagement with the intervention, and changes of AF-related health behaviors.
15839580|NCT04127799|Other|Subjects with AF conventional treatment|Subjects with standardized treatment according to latest guidelines via conventional visit.
15839581|NCT04127786|Biological|Purified vero rabies vaccine - serum free VRVg-2|Pharmaceutical form: Freeze-dried Route of administration: Intramuscular
15839582|NCT04127786|Biological|Purified inactivated rabies vaccine (Verorab)|Pharmaceutical form:Freeze-dried Route of administration: Intramuscular
15839583|NCT04127786|Biological|Purified inactivated rabies vaccine (Imovax rabies)|Pharmaceutical form: Freeze-dried Route of administration: Intramuscular
15839584|NCT04127773|Device|oro gastric tube|According to clinical need, an orogastric tube will be inserted at birth using the group method in VLBW infants in whom an umbilical catheter has been placed. An X-ray chest will be performed according to routine clinical practice to assess the position of the umbilical catheter. On the same X-ray the position of the gastric tube will be assessed by a radiologist blinded to the method used for orogastric tube placement.
15839585|NCT04127760|Radiation|radiotherapy|Radiotherapy would start within 2 months after the operation, and 5 days of radiotherapy is performed every week. The dose of each radiotherapy is 1.8 Gy for 6 weeks, and the total dose is 54 Gy.
15839586|NCT04127747|Drug|Standard dose of rituximab|Patients in this group will accept RTX 500mg treatment on the first day and on the 6th, 12th,18th and 24th month after that.
15839587|NCT04127747|Drug|Individualized dose of rituximab|Patients in this group will accept RTX 500mg treatment on the first day of admission. Patients will be followed-up every 3 months, and will receive one RTX 500mg treatment, if CD19 B cell count ≥ 1%, or dsDNA titer increased (dsDNA antibody positive, and increased more than 100% compared with the previous time), or complement C3 level decreased (lower than normal value, and decreased more than 50% compared with the previous time).
15839588|NCT04127734|Procedure|The efficacy of various interventions for anastomotic leakage after rectal cancer resection are investigated|Investigated interventions comprise conservative, radiological, endoscopic and surgical (including stoma formation) interventions
15839589|NCT04127721|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo ASCT
15839590|NCT04127721|Drug|Busulfan|Given IV
15839591|NCT04127721|Drug|Fludarabine|Given IV
15839592|NCT04127721|Drug|Itacitinib|Given PO
15839593|NCT04127721|Drug|Methotrexate|Given IV
15839594|NCT04127721|Drug|Tacrolimus|Given IV and PO
15839595|NCT04127708|Biological|acupuncture|acupuncture group and control group
15839596|NCT04127695|Drug|ABBV-0805|ABBV-0805 administered by IV infusion.
15839597|NCT04127695|Drug|Placebo ABBV-0805|Placebo ABBV-0805 administered by IV infusion.
15839598|NCT04127682|Other|Antibiotic KAP questionnaire|• Self-administered questionnaire will be used and containing following Physician information (age, sex, place of work, specialty, years of experience, place of work, and post graduate studies and trainings), Practice information (number of days for outpatient's practice/week, average number of patients /day and average percentage of children with ARIs/day), Antibiotic prescription practice (using of guidelines and causes of prescribing antibiotics in acute URIs), Knowledge about antibiotic resistance and attendance of any conference or educational activities concerned with antibiotic use during the last year, Attitude as regard antibiotic prescription.
15839599|NCT04127669|Drug|OSU 6162|The active ingredient of OSU6162 is the S-enantiomer with the chemical name (S)-3-[3-(methylsulfonyl)phenyl]-1-propylpiperidine hydrochloride. The substance is a white powder with a melting point of 177-182°C. Solubility in water is > 2000 mg/ml. Current laboratory code used is OSU6162-HCl. In trial protocol, OSU6162-HCl is shortened to OSU6162.
15839600|NCT04127669|Drug|Placebo oral tablet|Circular coated tablet (with identical appearance to active treatment tablets 15 mg).
15839601|NCT04127656|Other|Amino Acid-Based Experimental Study Formula|Amino acid-based study formula; feed ad libitum
15839602|NCT04127630|Procedure|mobilization of the larynx|we aim to asses with an magnetic resonance imaging the compressibility of the oesophagus with LPEC
15839603|NCT04127617|Other|Osteopathic Manipulative Treatment|"Osteopathic treatment
~Dural system:
~L5-S1 decompression; sacred decompression among the iliacs; occipital-sphenoid approach; decongestion of occipital condyles
~Fascial system:
~fascial techniques in the abdominal region: right hypochondrium, epigastrium, left hypochondrium, right side, mesogastrium, left side, right iliac area, hypogastrium, left iliac area; relationship with corresponding vertebral levels (eg, hypogastrium); fibro scar adhesions treatment.
~Biomechanical system:
~diaphragm rebalancing with respect to anatomical insertions; passive mobilization of dysfunctional areas. Nursing education as described in Standard Treatment"
15839730|NCT04126343|Drug|Padsevonil|"Pharmaceutical form: Film-coated tablet
~Route of administration: Oral use
~Study participants will receive padsevonil in a pre-specified dosing sequence during the Treatment Period"
15839604|NCT04127617|Other|Nursing Educational Care|"Nursing education
~assessment of the best personal evacuation strategy concerning the quality of life, individual resources, and level of autonomy;
~assessment of the correct execution of the identified evacuation manoeuvre (digital stimulation, manual removal, reflex stimulation, transanal irrigation, use of micro-enemas or suppositories;
~identification of the best postural strategies during evacuation;
~nutrition and proper hydration education;
~education in completing the evacuation diary;
~colonic massage training;
~verification of the correct hiring of any previously prescribed laxative drugs."
15839605|NCT04127604|Behavioral|Integrated Treatment Adherence Program for Veterans (ITAP-VA)|Psychosocial support and treatment to improve treatment adherence, symptoms, and functioning.
15839606|NCT04127604|Behavioral|Safety Assessment and Follow-up Evaluation (SAFE)|Measurement-based care assessment and evaluation.
15839607|NCT04127591|Other|exosome|Collect exosomes in peripheral blood of patients and extract miRNAs from them.
15839608|NCT04127578|Biological|PR001|Participants will receive a single dose of PR001, administered intra cisterna magna
15839609|NCT04127578|Drug|Methylprednisolone|1-2 IV pulses administered as concomitant medication
15839610|NCT04127578|Drug|Sirolimus|Loading dose, followed by maintenance dose, followed by dose tapering; administered as concomitant medication
15839611|NCT04127578|Drug|Prednisone|Administered orally as concomitant medication, followed by dose tapering
15839612|NCT04127578|Drug|Rituximab|Single IV pulse administered as concomitant medication.
15839613|NCT04127552|Procedure|Adrenalectomy|Adrenalectomy accordint to 2016 ESE guidelines
15839615|NCT04127526|Other|Connection to Environment with Cognitive Therapy (CONNECT)|8 sessions of strategies to reduce dissociation. Flexible, toolbox approach including but not limited to grounding strategies using objects, therapy oils and naming objects in the room.
15839616|NCT04127513|Drug|Ammonium Lactate|12% ammonium lactate moisturizing cream
15839617|NCT04127513|Drug|Urea|10% urea moisturizing cream
15839618|NCT04127500|Drug|dexmedetomidine|dexmedetomidine
15839619|NCT04127461|Device|Medtronic endoscope|The endoscope is a minimally invasive tool used to remove veins from the leg traditionally used for CABG.
15839620|NCT04127448|Other|Exergaming Training Group|"Training was given using X-box 360 Kinect. Dr. Kawashima's brain and body exercise game comprising of multiple cognitive games out of which 4 selected games were played by the participants. These games were Traffic control (participants have to guide the colored cars into their matching colored tunnels by using their arms), balloon buster (players pop numbered balloons in order from the lowest to the highest), pop till u drop, (match the color that appears on screen with the balloon of same color) and strike a pose (participant have to remember the poses shown and then copy them after few seconds). Games were played for 10 minutes initially then the duration was gradually increased to 30 minutes each session for 3 days/week and duration of 6 weeks. The session included 5-minute warm up, 20-minute interactive gaming, and 5-minute cool down."
15839621|NCT04127448|Other|Aerobic Exercise Group|Session of 30-35 minutes, 3 days a week for 6 weeks was given using treadmill (model no TMX58 220). Time and intensity was gradually increased over the duration of 6 weeks. Starting from 10 minutes in 1st week, every 5 minutes was added to aerobics phase to each week until patient reached to 35 minutes in week 6 maintaining the intensity of 40-60% of heart rate reserve (%HRR).
15839622|NCT04127409|Other|Control Chicken-meat|
15839623|NCT04127409|Other|Control Eggs|
15839624|NCT04127409|Other|Omega-3-PUFA Enriched Chicken-meat|
15839625|NCT04127409|Other|Omega-3PUFA Enriched Eggs|
15839626|NCT04127396|Drug|Lenvatinib Pill|Lenvatinib capsules will be administered orally, once daily in continuous 28-day cycles. Body weight (BW)>60 kilograms(kg)-Lenvatinib 12 mg (taken as three 4-mg capsules); BW<60kg-Lenvatinib 8 mg (taken as two 4-mg capsules)
15839627|NCT04127396|Procedure|Transarterial chemoembolization(TACE)|TACE will be performed one day after oral administration of lenvatinib . TACE with either cTACE or DEB-TACE can be used, depending on the condition of center.
15839628|NCT04127396|Drug|Sorafenib|Sorafenib capsules will be administered orally, 400 mg twice daily (BID) oral dosing.
15839629|NCT04127396|Procedure|Transarterial chemoembolization(TACE)|TACE will be performed one day after oral administration of Sorafenib. TACE with either cTACE or DEB-TACE can be used, depending on the condition of center.
15839630|NCT04127383|Device|Assessment of Burden of Chronic Conditions (ABCC)-tool|The tool consists of a questionnaire, a visualisation using balloons, and treatment advice. A patient completes the questionnaire before consultation. The questionnaire measures the experienced burden of the chronic condition(s), and several risk factors. The questionnaire consists of a generic part and disease-specific parts. The generic questionnaire will be combined with any amount of disease-specific questionnaires (i.e. COPD, asthma, diabetes type 2 and heart failure), to form a single personalised scale and balloon chart for each individual patient. Outcomes of the questionnaire are visualised using balloons. The healthcare provider opens the visualisation during consultation. A balloon represents a domain, and the colour and height indicate a score on that domain. If a patient and healthcare provider select a balloon by clicking on it, treatment advice is shown by means of pop-ups. Based on the discussion following treatment advice, personal care plans can be determined.
15839631|NCT04127370|Procedure|Bariatric Surgery|The Role of Bariatric Surgeries in Management of Nonalcoholic Fatty Liver Disease
15839657|NCT04127045|Procedure|HA-Group|In the older patient, the chance that the head of the femur is damaged in this way is higher. It is generally felt that for these displaced fractures, patients will do better if some of the components of the hip are replaced. In some cases, this can mean a replacement of the ball, or head of the femur (hemiarthroplasty).
15839757|NCT04126200|Drug|Belantamab mafodotin|Belantamab mafodotin will be administered
15839758|NCT04126200|Drug|GSK3174998|GSK3174998 will be administered
15839632|NCT04127357|Procedure|1450 ppm fluoride toothpaste brushing x Resin sealing (FluroShield, Dentsply, Brazil).|"After randomization of the children, the selected molars were allocated through a randomized sequence list in 2 groups: A. Brushing with 1450 ppm fluoride toothpaste, donated by the researcher; B. Resin Sealing (FluroShield, Dentsply, Brazil).
~The teeth included in the second group (group B) underwent a second randomization: B1. With absolute isolation; B2. With relative isolation. For the group with absolute isolation, topical anesthesia and local papillary infiltration were performed for subsequent staple placement. Relative isolation was performed with cotton rollers and moisture control suction. The sealant selected was the opaque fluroshield to facilitate visualization upon visual examination during reevaluations and was applied following the manufacturer's standards. The teeth were clinically and radiographically followed at 6 and 12 months and two sessions of motivation reinforcement were performed through video and brush change at 3 and 9 months."
15839633|NCT04127344|Behavioral|Music Therapy Intervention|Patients randomized to a music therapy intervention will receive an individualised music therapy intervention. The sessions will last 10-20 minutes and they will be done by music therapist and musician.
15839634|NCT04127331|Device|Point-of-Care Ultrasound|Portable ultrasonography done at the bedside.
15839635|NCT04127318|Behavioral|Pedaling Group|Participants will pedal at low-moderate intensity using a stationary pedal ergometer concurrent to their immunotherapy infusion (30 minutes).
15839636|NCT04127305|Other|No Intervention|No Intervention
15839637|NCT04127292|Behavioral|Emotional Self Awareness (ESA) Individual Feedback|Virtual Human Interaction (VHI) to train outpatient clinicians in emotional self-awareness (ESA) and receive clinician-focused, comprehensive feedback in ESA
15839638|NCT04127279|Biological|Cream|"The enriched cream is self-administered and contains a blend of 4 essential oils, namely Juniperus phoenicea gum extract, Copaifera officinalis resin, Aniba rosaeodora wood oil and Juniperus virginiana oil.
~The placebo cream is devoid of the essential oils"
15839639|NCT04127253|Device|Sooma transcranial direct current stimulation device plus Brain training tools|This group will carry out an observation training of actions and motor imagery in combination with the stimulation of the transcranial direct current.
15839640|NCT04127253|Device|Placebo Sooma transcranial direct current stimulation deviceplus Brain training tools|This group will carry out an observation training of actions and motor imagery in combination with the placebo stimulation of the transcranial direct current, where it will be acrtivo during 15 seconds and then it will be turned off during the rest of the intervention.
15839641|NCT04127253|Behavioral|Brain training tools in isolation|This group will act as a control, they will only carry out the training of action observation and motor imagery.
15839642|NCT04127240|Other|DASH diet containing daily intakes of red meat|Each participant was randomized to consume 3 or 6 ounces of red meat as a part of the DASH dietary pattern for 12-weeks.
15839643|NCT04127227|Drug|sintilimab,pegaspargase,gemcitabine,oxaliplatin|"All patients enrolled in the study will accept sintilimab with P-GemOx (pegaspargase, gemcitabine and oxaliplatin) regimenas their first-line therapy.
~Stage IV patients with localized disease will be treated with consolidative RT. Patients with CR or PR will receive sintilimab maintenance therapy"
15839644|NCT04127214|Other|ITA Integrated Treatment|The ITA Model combines outpatient intervention (mainly psychotherapy), day hospital care and hospitalization as a function of patients' characteristics. Case conceptualization of the psychological processes of patients is formulated and revised within a team including psychologists, psychotherapists, psychiatrists, nutritionists, physicians, nurses, and social workers. The major emphasis of the ITA model is on psychological interventions which include individual psychotherapy, family therapy and/or guidance, and group therapy of various formats and contents (e.g., drug abuse, mindfulness, emotion work) tailored to the needs of each patient. However, when required, drugs are prescribed adjusting type of medication and dosage to the need of the patient.
15839645|NCT04127201|Behavioral|en_línea|This is an online adaptation of the LEARN program. A self-help weight control program developed by Kelly Brownell in 2004.
15839646|NCT04127201|Behavioral|Group therapy|This is a traditional behavioral weight control program
15839647|NCT04127175|Device|Volpara|This tool represents a physics-based model which extract pixel-wise information from the FFDM or DBT images, and combine it with metadata information from the DICOM header and appropriate linear attenuation coefficients of both adipose and glandular tissue.
15839648|NCT04127149|Diagnostic Test|Ultrasound scan|The group uses an ultrasound device for the consultation.
15839649|NCT04127136|Behavioral|Multi-disciplinary obesity management therapy|In twenty weeks, trainings by the physician, dietitian, psychologist and physiotherapist are conducted about medical information about obesity, using the technology to aid weight loss, what, when, how and why to eat, nutrition groups, ration management, water consumption, self-awareness, stress management, obesity and the association between the psychological processes, warming up and mobilization, correct stance and posture, and adequate physical activity. In addition to group meetings, in monthly individual meetings, the progress of the patients are evaluated.
15839650|NCT04127110|Drug|Lorlatinib|Lorlatinib is administered orally at the daily dose of 100 mg (four tablets of 25 mg).
15839651|NCT04127097|Other|cartoon group|The children in the groups were distracted by watching cartoon 2 minutes before treatment, until the process was over
15839652|NCT04127084|Drug|SGLT2 Inhibition|Dapagliflozine 5-10 mg once daily tablet treatment or Empagliflozin10 mg once daily tablet treatment or Canagliflozin 100 mg once daily tablet treatment
15839653|NCT04127071|Procedure|Ultrasound-guided Needle Aspiration Procedure|The intervention under investigation utilizes an ultrasound-guided needle to less invasively drain an abscess.
15839654|NCT04127071|Procedure|Incision and Drainage (I&D)|The current standard procedure to drain an abscess of purulent material.
15839655|NCT04127058|Drug|Iloperidone|Oral Tablet
15839656|NCT04127045|Procedure|IMN-Group|Most intertrochanteric fractures are managed with an intramedullary nail, which allows for impaction at the fracture site. The intramedullary nail is placed directly into the marrow canal of the bone through an opening made at the top of the greater trochanter. A lag screw is then placed through the nail and up into the neck and head of the hip. As with the compression hip screw, sliding of the lag screw and impaction of the fracture take place.
15839697|NCT04126681|Drug|Imatinib, Dasatinib or Nilotinib|Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines.
15839658|NCT04127032|Behavioral|PSP Wellbeing Course|A tailored ICBT intervention will be delivered to public safety personnel who report symptoms of depression, anxiety, or posttraumatic stress. Clients will choose whether they prefer weekly therapist support, twice-weekly support, or monitored optional support. The intervention is designed to be completed in 8 weeks, but clients will be able to extend their treatment by an additional 8 weeks (i.e., up to 16 weeks in total).
15839659|NCT04127019|Drug|Paclitaxel|Paclitaxel chemotherapy (injection)
15839660|NCT04127019|Drug|Docetaxel|Docetaxel chemotherapy (injection)
15839661|NCT04127019|Drug|Cyclophosphamide|Cyclophosphamide chemotherapy (injection)
15839662|NCT04127019|Drug|Epirubicin|Epirubicin chemotherapy (injection)
15839663|NCT04127019|Drug|5-fluorouracil|5-fluorouracil chemotherapy (injection)
15839664|NCT04126993|Drug|Camrelizumab,|Camrelizumab+ Apatinib test group: intravenous injection once every three weeks, Apatinib 500 mg is administered orally daily, until disease progression or untolerable toxicity.
15839665|NCT04126993|Drug|Apatinib|Apatinib single drug control group: Apatinib 500 mg is administered orally daily, until disease progression or untolerable toxicity.
15839666|NCT04126980|Behavioral|Rates of readmission and reoperation|All patients were then followed-up for 180 days after the indexed surgery of lumbar fusion. All-causes of re-hospitalization and re-operations for lumbar spine fusion, were analyzed at 30, 60 and 180 days for comparison between the ED group and the comparison group.
15839667|NCT04126967|Diagnostic Test|NGS patients|The next generation sequencing technique (NGS) was used to monitor the minimal residual lesions after allogeneic hematopoietic stem cell transplantation
15839668|NCT04126954|Other|Serum PTH concentrations results|To compare serum PTH concentrations results in patients with primary or secondary hyperPTH resulting from phosphocalcic pathology before and three months after initiation of cinacalcet therapy.
15839669|NCT04126941|Other|Serum calcium concentrations results|To compare serum calcium concentrations results in patients with hypoparathyroidism before and three months after initiation of teriparatide therapy
15839670|NCT04126928|Diagnostic Test|Screening using DMFT and PUFA, orthopantomogram is taken and assessed using PAI, comprehensive clinical examination to diagnose pulpal and periapical conditions.|
15839671|NCT04126915|Genetic|Whole Exome Sequencing|Whole Exome Sequencing of the patient's primary tumor, metastases
15839672|NCT04126902|Other|interleukin-6, presepsin and pentraxin-3|measurements and compare
15839673|NCT04126889|Other|questionnaire survey|questionnaire survey
15839674|NCT04126876|Drug|Tilsotolimod|Intradermal, single injection of 1 ml (8 mg) Tilsotolimod (IMO-2125) at the primary melanoma excision site, one week prior to sentinel node biopsy (SNB).
15839675|NCT04126876|Drug|Saline (0.9% sodium chloride)|Intradermal, single injection of 1 ml plain saline (0.9% sodium chloride) at the primary melanoma excision site, one week prior to sentinel node biopsy (SNB).
15839676|NCT04126837|Other|Diagnosis and treatment|Monocentric, Prospective and Biomedical Research excluding Health Product
15839677|NCT04126824|Drug|Triamcinolone|40 mg triamcinolone administered as a Superior Hypogastric Nerve Block (SHNB)
15839678|NCT04126824|Drug|Bupivacaine|0.5% bupivacaine (20 mL) administered as a Superior Hypogastric Nerve Block (SHNB).
15839679|NCT04126824|Other|Iohexol contrast|The appropriate amount of contrast to enable visualization of the nerve block under fluoroscopy given as a Superior Hypogastric Nerve Block (SHNB) will be administered.
15839680|NCT04126811|Drug|Apatinib Mesylate, Pirarubicin, Ifosfamide|Apatinib 500mg, orally, once a day. One cycle every 4 weeks. Pirarubicin 75mg/m2 D1, intravenous infusion for 1-2 hours; every 4 weeks. Ifosfamide 2g/m2/d D1-D5, intravenously for 4-6 hours, 1 cycle every 4 weeks.
15839681|NCT04126811|Drug|Apatinib Mesylate|Apatinib 500mg, orally, once a day. One cycle every 4 weeks.
15839682|NCT04126811|Drug|Pirarubicin, Ifosfamide|Pirarubicin 75mg/m2 D1, intravenous infusion for 1-2 hours; every 4 weeks. Ifosfamide 2g/m2/d D1-D5, intravenously for 4-6 hours, 1 cycle every 4 weeks
15839683|NCT04126798|Other|Behavioural|Assessment of the 2BALANCE protocol: dual-task protocol consisting of a motor task, cognitive task, and motor-cognitive dual-tasks
15839684|NCT04126785|Other|High Intensity Interval Exercise in Heated Water-Based|High intensity interval exercise will perform at controlled heated water-base (30 e 32 ºC). Subject will be submerged at the xiphoid process level. The session will consist in 4 min walking (warm-up) at 9 level of rate perceived exertion (RPE) scale, followed by 21 min of HIIE, alternating 1 min of jogging/running at 15-17 (hard-very hard) level with 2 min of walking at 9-11 (very light-fairly light) level of RPE.
15839685|NCT04126785|Other|Continuous Moderate Exercise in Heated Water-Based|Continuous moderate exercise will perform at controlled heated water-base (30 e 32 ºC). Subject will be submerged at the xiphoid process level. The session will consist in 4 min walking (warm-up) at 9 level (light) of RPE, followed by 26 min of MICE, walking at 11-13 (fairly light)level of RPE.
15839686|NCT04126785|Other|Control Group|CON session will perform at controlled heated water-base (30 e 32 ºC). Subject will be seated in a chair and submerged at the until xiphoid process level for 30 min.
15839687|NCT04126759|Device|P0.3|Subjects will perform daily measurements on the IMD (Prototype 0.3) for 35 days.
15839688|NCT04126733|Drug|Regorafenib (Stivarga, BAY73-4506)|Regorafenib administered as oral tablets given every day for 3 weeks of each 28 days treatment cycle (i.e., 3 weeks on, 1 week off)
15839689|NCT04126733|Biological|Nivolumab (Opdivo)|Administered on day 1 of every treatment cycle.
15839690|NCT04126720|Dietary Supplement|topical corticosteroids and vitamin E suplements|
15839691|NCT04126720|Drug|Topical corticosteroid and placebo capsules|
15839692|NCT04126707|Drug|[14C] HQP1351|Orally, single dose of 30mg
15839693|NCT04126694|Behavioral|CBT with smartphone application SenseSupport|SenseSupport intervention system used as an augment to a 12 week in-person CBT treatment for transdiagnostic binge eating pathology
15839694|NCT04126681|Drug|HQP1351|HQP1351 is a new, bioavailable inhibitor against BCRABLWT and a broad spectrum of BCR-ABL mutants including BCR-ABLT315I
15839695|NCT04126681|Drug|Hydroxyurea or Interferon-based therapy|Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines.
15839696|NCT04126681|Drug|Homoharringtonine|Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines.
15839698|NCT04126668|Drug|CM082 with fed or fasting|The two groups of subjects were given an equal dose of CM082 tablet (200 mg) after a single cross-over fasting or high-fat high-calorie diet in two different test cycles to examine the effect of food on the pharmacokinetics of CM082.
15839699|NCT04126655|Drug|Arfolitixorin|Per operative administration of 5-FU with Arfolitixorin or Calciumfolinate
15839700|NCT04126642|Behavioral|Assessment only group|Individuals randomized to this group will receive radiation therapy as usual plus baseline, follow-up, and EMA assessments.
15839701|NCT04126642|Behavioral|Intervention group|Individuals randomized to the intervention group will complete the same measures (in person and daily EMAs) as the assessment only group, but will additionally receive messaging that is tailored to patient responses on EMAs.
15839702|NCT04126616|Diagnostic Test|chest Magnetic Resonance Imaging (MRI) using Gadolinium-based contrast agent|chest MRI will be performed at rest and after moderate exercise
15839703|NCT04126603|Drug|Semaglutide|0.25mg/week for week 0 - 4 , then increasing to 0.5mg/week for weeks 5 - 8, then 1 mg/week for week 9 - 24 weeks
15839704|NCT04126603|Drug|Placebos|Placebo injection
15839705|NCT04126590|Biological|KN044|"The modified phase I 3 + 3 study design was used in dose escalation from low dose to high dose to determine the MTD.Sequential assignment of Patient cohorts to one of five dose levels of KN044: 0.03mg/kg,0.3 mg/kg,1 mg/kg,3 mg/kg,6 mg/kg,10 mg/kg."
15839706|NCT04126577|Biological|blood samples|4 blood samples of 6 ml each: one before the surgical incision, one after the operation, one 4h after the operation and the last 24h after the operation.
15839707|NCT04126564|Behavioral|Inner Engineering Online|Inner Engineering Online (IEO) is a web based intervention administered by the Isha Foundation, a not-for-profit, global, volunteer-based organization.The Inner engineering online program is a holistic tool for promoting well-being that teaches individuals how to mindfully and effectively respond to daily stressors using yogic sciences. The program offers guided meditation and yoga practices to promote harmonizing mind-body-emotion, and energy of the individual while simultaneously promoting mindfulness, joy, and vitality. It includes seven modules of 90 minutes each, discussing meditations & yoga.
15839708|NCT04126564|Behavioral|Reading a book/ journal|Reading a book regularly promotes knowledge enhancement, reduces stress and enhances memory among other benefits. For the purpose of this study, we advocate reading any book/ journal of participants choice routinely.
15839709|NCT04126551|Other|Methylation status|Participants will be recruited, and muscle biopsies will be obtained for methylation analyses and measuring mitochondrial function
15839710|NCT04126538|Drug|pirfenidone capsule|In the patient group, pirfenidone capsule was taken orally once for 400mg
15839711|NCT04126538|Drug|pirfenidone capsule|Healthy subjects took pirfenidone capsule 400mg once orally
15839712|NCT04126525|Drug|Pyrotinib|dual HER2 blockade in the neoadjuvant setting
15839713|NCT04126512|Other|PDA ligation|PDA ligation was performed at bedside, if a local cardiac surgery team was available, or in the case this service was not available, infants were referred to off-site specialist paediatric cardiac surgical services, where PDA ligation was performed.
15839714|NCT04126486|Other|Zio®XT Monitor|A Zio® XT monitor will be affixed to the participant's chest
15839715|NCT04126473|Drug|ELX-02|ELX-02 is a small molecule, new chemical entity being developed for the treatment of genetic diseases caused by nonsense mutations. ELX-02 is a eukaryotic ribosomal selective glycoside (ERSG).
15839716|NCT04126460|Drug|Toripalimab|Toripalimab is a type of PD-1 antibody
15839717|NCT04126434|Device|mask|facemask
15839718|NCT04126421|Device|Prosthesis component (acetabular cup) E1 cup|Semented acetabuar cup With E1 cup
15839719|NCT04126421|Device|Prosthesis component (acetabular cup) Marathon cup|Semented acetabuar cup With Marathon cup
15839720|NCT04126408|Device|gammaCore|The intervention consists of a transcutaneous non-invasive stimulation of the cervical branch of the vagus nerve (nVNS) using gammaCore, an FDA approved device for the treatment of migraine and cluster headache. This will be compared to the sham device, which is the same device which will not provide stimulation to the nerve. Stimulation frequency will be identical to the frequency used in previous nVNS studies for the treatment of migraine headache.
15839721|NCT04126395|Diagnostic Test|Movement Assessment Battery for Children 2(M-ABC-2)|The M-ABC-2 is a motor performance test for children aged 3 trough 16 years of age. We will use Dutch-Flemish norms.
15839722|NCT04126395|Diagnostic Test|Developmental Coordination Disorder - Questionnaire (DCD-Q)|The DCD-Q is a brief parent questionnaire designed to screen for the presence of DCD in children aged 5 trough 15 years of age. We will use Dutch norms.
15839723|NCT04126395|Diagnostic Test|Social Responsiveness Scale 2 (SRS-2)|The SRS-2 is a parent questionnaire designed to identify social impairments associated with ASD in children 4 trough 18 years of age. We will used Dutch norms.
15839724|NCT04126395|Other|Retrospective Video Analysis|Retrospective video analysis will be used to explore motor development in children with DCD, DCD+ASD and controls.
15839725|NCT04126382|Procedure|Intubate-Surfactant-Extubate(INSURE)|Infants are given an endotracheal intubation, with manual lung inflation in order to keep the oxygen supply，and the surfactant(kelisu,China Resources Shuanghe Pharmaceutical) was slowly instilled into the airway through the tracheal tube, and the tracheal tube was removed for non-invasive NCPAP(nasal continuous positive airway pressure)-assisted breathing.
15839726|NCT04126382|Procedure|less invasive surfactant administration(LISA)|Infants are spontaneously breathing with nasal CPAP(continuous positive airway pressure) support without manual lung inflation and surfactant(kelisu,China Resources Shuanghe Pharmaceutical) is administered through vocal cords via a smaller catheter.
15839727|NCT04126369|Other|mindfulness intervention|The mindfulness program is conducted in a group session of up to 10 people. Each session lasts 2 hours. A total of 12 sessions will be conducted by a practitioner who is specifically trained in this type of programme.
15839728|NCT04126369|Other|psycho educative programme|The psycho-educational control intervention will follow the same format and structure as the mindfulness meditation intervention in terms of group format, session duration and frequency. This is a therapeutic education programme developed for several years in the neurology department of the university hospital of Lyon and Grenoble. The program follows the repository recommended by the french league against epilepsy.
15839729|NCT04126356|Procedure|mobilization of the larynx|Check the intubation conditions during laryngoscopy without external mobilization of the larynx, with Sellick manoeuvre or with low paratracheal esophagal compression.
15839731|NCT04126343|Drug|Moxifloxacin|"Pharmaceutical form: Film-coated tablet
~Route of administration: Oral use
~Study participants will receive moxifloxacin once during the Treatment Period"
15839732|NCT04126343|Drug|Placebo|"Pharmaceutical form: Film-coated tablet
~Route of administration: Oral use
~Study participants will receive placebo in a pre-specified sequence during the Treatment Period to match padsevonil and maintain the blinding"
15839733|NCT04126330|Dietary Supplement|Probiotic, Omega-3, Vitamin D supplement|"The first supplement we would like to assess is named VNP and is composed by Omega-3 Active and vitamin D. It contains a total of 1100 mg fish oils: 640 mg Omega-3 and with 300 mg eicosapentaenoic acid (EPA), 220 mg docosahexaenoic acid (DHA) plus 200 IU Vitamin D per daily dose (2 capsules).
~The second supplement we investigate is four-strain probiotics combination based on the commercially available formulation HOWARU® by DuPont; two capsules containing 10 billion CFU total (supplied by Pfizer but manufactured by Danisco, DuPont). The probiotic specific composition, contains equal amounts of each strain per capsule (1.25 x 109 CFU each): Bifidobacterium lactis Bi-07, Lactobacillus paracasei Lpc-37, Lactobacillus acidophilus NCFM, Bifidobacterium lactis Bl-04. One capsule contains 5 billion CFU (Swedish milliards)."
15839734|NCT04126330|Dietary Supplement|Placebo|Placebo generated for probiotic and omega-3/vitamin D supplements
15839737|NCT04126304|Drug|Azithromycin|If the diagnosis is common cold, acute bronchitis or post-infection cough ，treated with non-macrolides when the mycoplasma colloidal gold test is negative, treated with azithromycin when colloidal gold test is positive.
15839738|NCT04126304|Drug|non-macrolides antibiotics|If the diagnosis is community-acquired pneumonia with negative mycoplasma antibody-granule agglutination, non-macrolides are used for treatment
15839739|NCT04126304|Diagnostic Test|Mycoplasma detection|"common cold, acute bronchitis or post-infection cough :MPlgM colloidal gold detection;Pharyngeal swab MP-RNA PCR, mutated gene detection at 2063 and 2064 site of macrolide-resistant 23S rRNA II region detection
~community-acquired pneumonia:mycoplasma antigen antibody particle agglutination detection ;Sputum MP-RNA PCR, mutated gene detection at 2063 and 2064 site of macrolide-resistant 23S rRNA II region detection"
15839740|NCT04126304|Other|Data collection|"Common cold:On enrollment, day 3 and day 7, scores were collected based on the Canadian acute respiratory diseases and influenza scale (CARIFS scale), success rate of initial treatment, antimicrobial conversion rate, intravenous rehydration rate, pneumonia conversion rate, re-visit rate, and hospitalization rate.
~Acute bronchitis :on enrollment, day 3, and day 7, the Likert 7 subscale was used to score the cough severity questionnaire, collect the success rate of initial treatment, antimicrobial conversion rate, intravenous rehydration rate, pneumonia conversion rate, re-visit rate, and hospitalization rate.
~Post-infection cough:on the day after outpatient visit, day 3, day 7, and day 14, the cough severity questionnaire (Likert 7 subscale) was used to score the success rate of initial treatment, antimicrobial conversion rate, intravenous rehydration rate, pneumonia conversion rate, re-visit rate, and hospitalization rate."
15839741|NCT04126304|Other|Data collection|Acquisition of children hospitalized time, heating time, mixed infection, drug (azithromycin, tetracycline, quinolone) dose and use time, pulmonary complication (pleural effusion, atelectasis, necrotizing pneumonia, interstitial pneumonia, occlusive bronchitis, occlusive bronchiolitis, lung, emphysema, lung abscess, bronchiectasis, transparent), pleural puncture/drainage, bronchoscope, oxygen time, into the ICU, mechanical ventilation time, surgery, and deaths and re-visit, hospitalization, surgery and death within 30 days after discharge
15839742|NCT04126291|Behavioral|Evaluation of whiteboard videos|Participants will be provided an internet link via email to access the videos and questionnaires through REDCap (Research Electronic Data Capture), and responses will be tracked. Before viewing, participants will complete a pre-questionnaire to collect demographic and practice data and ratings of perceived self-efficacy/confidence and knowledge in talking about weight-related issues. This pre-questionnaire only needs to be completed once. Participants will then be asked to watch each video. Immediately after watching each video, participants will rate their perceived self-efficacy/confidence and knowledge to help elucidate outstanding educational gaps. For those who consent to do a follow up questionnaire four-six months later, they will be sent an email link to complete a satisfaction questionnaire and rate their perceived self-efficacy/confidence and change in practice to help elucidate outstanding educational gaps.
15839743|NCT04126278|Drug|Barbotage|Administered as per standard of care
15839744|NCT04126278|Drug|Dexamethasone|4 mg of dexamethasone
15839745|NCT04126265|Device|Artificial intelligence assisted colonoscopy|The colonoscopy is connected to the real-time polyp detection system. If the polyp is detected by enteroscopy, the alarm will be given.
15839746|NCT04126252|Drug|Sildenafil Citrate 50Mg Tab|The Group A received sildenafil citrate 50 mg on demand for a period of max 3 months.
15839747|NCT04126252|Behavioral|Cognitive Behavioral Psychotherapy|The Group B received cognitive behavior psychotherapy for a period of max 3 months.
15839748|NCT04126252|Combination Product|Combined or Integrated Therapy|The Group C received the combined therapeutic approach for a period of max 3 months.
15839749|NCT04126252|Other|Placebo|The Group D received no treatment or placebo for a period of max 3 months.
15839750|NCT04126239|Other|Online survey - questionnaire|Online survey - questionnaire
15839751|NCT04126226|Other|Speech-language guidance|Speech-language guidance for speech enhancement and on food management in terms of consistency, volumes, utensils and temperature, beyond the care for safe and efficient swallowing.
15839752|NCT04126226|Other|Speech therapy exercises for swallowing|Use of lip exercises and facial muscles, laryngeal elevation maneuver and airway protection technique, 5 repetitions 3 times a day for a month.
15839753|NCT04126226|Other|Speech therapy exercises for speech|Use of over-articulation technique and glottal firmness exercise, 5 repetitions 3 times a day for a month.
15839754|NCT04126213|Biological|RSVPreF3 formulation 2|One single dose of RSVPreF3 vaccine administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.
15839755|NCT04126213|Biological|RSVPreF3 formulation 3|One single dose of RSVPreF3 vaccine administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.
15839756|NCT04126213|Drug|Placebo|One single dose of placebo (NaCl solution) administered intramuscularly in the deltoid region of the non-dominant arm on Day 1.
15839764|NCT04126174|Device|femtosecond laser system arcuate corneal incision|Corneal arcuate incision made either with a blade (manual) or femtosecond laser system.
15839765|NCT04126174|Other|Manual LRI|Manual LRI
15839766|NCT04126161|Procedure|CT|standard of care CT prior to primary hip replacement
15839767|NCT04126161|Device|Ultrasound|Ultrasound scan together with standard of care CT prior to primary hip replacement
15839768|NCT04126135|Drug|Cytisine|Subjects will take a 25-day course of Cytisine tablets started during the 4 days before the quit date. They will be asked to reduce smoking during this time.
15839769|NCT04126135|Drug|Nicotine Replacement Therapy (NRT)|Subjects are asked to completely stop smoking on their quit day and use a daily NRT patch for 25 days.
15839770|NCT04126122|Diagnostic Test|Ultrasonography to assess fetus and mother|to assess fetal growth and maternal outcome
15839771|NCT04126109|Other|questionaire|A questionaire will be offered to every parents
15839772|NCT04126096|Diagnostic Test|Skin Testing beta-lactams|Percutaneous skin prick followed by Intradermal Injections of NMBAs at increasing concentrations compared with an established positive and negative control.
15839774|NCT04126070|Drug|Androgen Deprivation Therapy|Given per standard care for duration of study. Regimens include Leuprolide (Lupron Depot) intramuscularly every 3 months, Goserelin acetate (Zoladex) subcutaneously every 4 weeks, or degarelix (Firmagon) subcutaneously every month per standard of care.
15839775|NCT04126070|Drug|Nivolumab|Given once per every 3 weeks for cycle 1-6 intravenously and then every 4 weeks during subsequent cycles, at predetermined dosage; up to 28 cycles total.
15839776|NCT04126070|Drug|Docetaxel|Given once every 3 weeks intravenously at pre determined dosage for cycle 1-6.
15839777|NCT04126057|Device|SightGlass Vision DOT Spectacle Lenses|Subjects randomized to test vs control, left eyes and right eyes
15839778|NCT04126044|Drug|PF-06439535 (CN)|This is the test drug Pfizer biosimilar of bevacizumab-EU.
15839779|NCT04126044|Drug|bevacizumab - EU|This is the reference drug bevacizumab sourced from EU
15839782|NCT04126018|Diagnostic Test|MRI with strain measurement|CMR measurements of left and right ventricular systolic function strain and myocardial fibrosis
15839783|NCT04126018|Diagnostic Test|Echocardiography|Doppler, PISA, VCA, volumetric method as performed during echocardiography
15839784|NCT04125992|Procedure|distal radial artery access in coronary angiography and angioplasty|"The patient grasps his thumb towards the palm to bring the radial artery up to the surface. The left hand is set on the right side of the groin toward the operator, who stands on the right side, with the dorsal surface of hand upwards.
~Afterward, the access site is disinfected, lidocaine HCL is SC injected for local anesthesia. Subsequently, the distal radial artery is palpated to find the point of the strongest pulse. Later, at a 45-degree angle, the artery is punctured with a 21-gauge needle and a 0.018 soft, flexible, metallic wire is then inserted in the needle. Through the sheath, 200 micrograms of Nitroglycerin is given. A 5000 unit of unfractionated heparin is administered through the IV line. A weight-adjusted dose of heparin is further added if PCI is needed. Then, a 0.035 wire is introduced in the sheath with other required instruments such as the intracoronary device and the catheters. After pulling out the sheath, a compression device, Safe Guard, is used for hemostasis."
15839785|NCT04125992|Procedure|Forearm radial artery access in coronary angiography and angioplasty|"The right hand is set in the anatomical position, with the anterior surface of arm face upwards.
~Afterward, the access site is disinfected, lidocaine HCL is SC injected for local anesthesia. Subsequently, the forearm radial artery is palpated to find the point of the strongest pulse. Later, at a 45-degree angle, the artery is punctured with a 21-gauge needle and a 0.018 soft, flexible, metallic wire is then inserted in the needle. Through the sheath, 200 micrograms of Nitroglycerin is given. A 5000 unit of unfractionated heparin is administered through the IV line. A weight-adjusted dose of heparin is further added if PCI is needed. Then, a 0.035 wire is introduced in the sheath with other required instruments such as the intracoronary device and the catheters. After pulling out the sheath, a compression device, TR band, is used for hemostasis."
15839786|NCT04125979|Other|In minimally invasive surgery，Vagus nerve preservation|In minimally invasive surgery for lung cancer, the experimental group retained the pulmonary branches of vagus nerve
15839787|NCT04125979|Other|In minimally invasive surgery，Vagus nerve is not preserved|In minimally invasive surgery for lung cancer, the control group did not retain the vagus nerve.
15839788|NCT04125953|Device|Andullation|Andullation is a horizontal vibration technique with stochastically modulated vibrations, build-in in a mattress.
15839789|NCT04125953|Other|Placebo|Placebo Andullation
15839790|NCT04125940|Dietary Supplement|Resync|The product known as Resync contains a blend of nitrate-rich foods including beetroot, red spinach, turmeric, ginger root, and aronia berry extracts. Resync is sold commercially and marketed as an ergogenic aid and/or exercise recovery aid.
15839791|NCT04125940|Dietary Supplement|Resync + Collagen|17g Collagen + 2g Resync + 1g Carbohydrate
15839792|NCT04125940|Other|Placebo|12oz water + food coloring
15839793|NCT04125927|Drug|Mercaptamine|Patients will be treated with 1 drop in each eye 4 times a day, at the same dose and regimen than the one indicated in adults and children from 2 years of age.
15839794|NCT04125914|Behavioral|Behavioral Dietary Intervention|Record food intake
15839795|NCT04125914|Other|E-mail|Receive e-mails
15839796|NCT04125914|Behavioral|Exercise Intervention|Undergo exercise
15839797|NCT04125914|Other|Internet-Based Intervention|Join Facebook page
15839798|NCT04125914|Other|Questionnaire Administration|Ancillary studies
15839799|NCT04125914|Behavioral|Telephone-Based Intervention|Receive telephone coaching
15839800|NCT04125914|Other|Text Message|Receive text messages
15839872|NCT04125186|Diagnostic Test|Testing of EpiNP baseline survey, bladder diary and a qualitative interview|This part briefly reviews the usability of the EpiNP survey and bladder diary. The feedback obtained after qualitative interview will be used to refine and finalize the instructions sent to the participants in the main part.
15839801|NCT04125901|Other|Pain Neuroscience Education and Exercise|The incorporation of the exercise in this group will be gradual, in order to decrease the education component and increase the exercise component (up to 45/60 minutes). The 1st session will be only PNE and will last approximately 45 minutes. In the 2nd session, there will be 30 minutes of PNE and the remaining 15 minutes of exercise. In the following 4th and 6th sessions, 15 minutes of each session will be used to clarify doubts and emphasize PNE concepts and strategies. The 8th session will include exercises only. In WhatsApp sessions, in addition to the video with the exercises, participants will receive activities about the PNE.
15839802|NCT04125901|Other|Exercise|The exercise group will perform exercises in all sessions (45 minutes of exercise in face-to-face sessions). In WhatsApp sessions, participants will receive a video with exercises to perform at home.
15839803|NCT04125888|Drug|Allergy immunotherapy (AIT)|Immunotherapy for different types of allergies
15839804|NCT04125875|Diagnostic Test|Electrogastrogram(EGG)|Heart Rate Variability
15839805|NCT04125875|Diagnostic Test|Heart Rate Variability(HRV)|Heart Rate Variability
15839806|NCT04125862|Diagnostic Test|MRI-based Neuroimaging|During evoked pain fMRI, noxious pressure and heat stimuli will be applied in the two anatomical sites noted above. During fMRI data acquisition, a total of 5 pressure stimulations and 5 heat stimulations will be delivered. Both types of pain stimuli will be applied in a 36/17-sec off/on cycle. The off-condition will correspond to a baseline temperature of 35C and the on condition will match the subject-specific and site-specific 7/10 pressure and heat pain thresholds defined during QST procedures. VAS pain ratings associated with evoked pain stimulation will be collected at the end of each scan. The investigators will also explore the structural properties of the CNS by implementing high-resolution anatomical MRI (gray matter volumes) and diffusion tensor imaging (white matter pathway integrity). All CNS imaging will take approximately 50-60 minutes to complete
15839807|NCT04125862|Diagnostic Test|Non-contrast MRI|Musculoskeletal imaging of the affected lower extremity. Patients will be allowed to watch a movie during data acquisition. The following MRI procedures will be completed in order to identify soft tissue lesions in active or painful regions. Fast spin echo (FSE) T2 fat saturated, T1 weighted MRI, FSE proton density MRI, Short-TI Inversion Recovery (STIR), Diffusion weighted MRI (DW-MRI) and 3D Double Echo Steady State (DESS) will be collected. All musculoskeletal MRI will take approximately 30 minutes to complete.
15839808|NCT04125862|Diagnostic Test|18F-FDG-PET/CT|Data will be collected 30 min after the intravenous administration of 18F-FDG with an expected average dose of approximately 200 MBq. CT data will be collected at a low-dose to minimize radiation exposure. Patients will be positioned supine head-first with arms on the side. The investigators project whole body data to be collected, but in some cases, the field of view may be limited to the patient's skull to below the knees. The data acquisition period is expected to last between 15-30 minutes and total radiation dose will be ~3-4 mSv.
15839809|NCT04125862|Diagnostic Test|18F-NaF-PET/CT|Data will be collected 30 min after the intravenous administration of 18F-NaF with an expected average dose of approximately 200 MBq. CT data will be collected at a low-dose to minimize radiation exposure. Patients will be positioned supine head-first with arms on the side. The investigators project whole body data to be collected, but in some cases, the field of view may be limited to the patient's skull to below the knees. The data acquisition period is expected to last between 15-30 minutes and total radiation dose will be ~3-4 mSv.
15839810|NCT04125849|Procedure|Thoraco-laparoscopic esophagectomy|Thoraco-laparoscopic esophagectomy surgery
15839811|NCT04125849|Procedure|Mediastinoscopy-assisted transhiatal esophagectomy|Mediastinoscopy-assisted transhiatal esophagectomy surgery
15839812|NCT04125836|Drug|CAM2029 (octreotide subcutaneous depot)|Octreotide subcutaneous depot for monthly injections in acromegaly patients
15839813|NCT04125823|Behavioral|Video game-based physical activity training|"Based on the physical levels of the patients, appropriate games will be selected and video game based physical activity training will be started. Video games will be played with Xbox One with a motion sensor (Microsoft) and a 52'' Liquid Crystal Display. Depending on the prognosis of the patients, the grades and types of games will be changed.
~Sessions will be performed by a physiotherapist for 45 minutes once a day during the hospital stay."
15839814|NCT04125823|Behavioral|Conventional physiotherapy program|"A conventional physiotherapy program including balance, upper extremity, and core stabilization exercises will be implemented.
~Sessions will be performed by a physiotherapist for 45 minutes once a day during the hospital stay."
15839815|NCT04125810|Biological|Probiotic|Probiotic
15839816|NCT04125810|Other|Placebo|Placebo
15839817|NCT04125797|Other|Application of adhesive|Adhesive will be placed on the subjects skin below the bra. Placement of the adhesive will be randomized.
15839818|NCT04125771|Diagnostic Test|Diclofenac + HBB with hysteroscopy|Giving Diclofenac + HBB with hysteroscopy
15839819|NCT04125771|Diagnostic Test|Diclofenav + placebo|Giving Diclofenac + placebo with hysteroscopy
15839820|NCT04125758|Behavioral|Mindfulness training|Brief audio recordings discussing mindfulness or guided mindfulness practices.
15839821|NCT04125758|Behavioral|Tracking time spent on mobile device|Participants will record each day how much time they estimate they spent on their smart phone in the past 24 hours.
15839822|NCT04125745|Drug|CXA-10|Each subject will receive oral CXA-10 at the dose of 300 mg once daily for 12 weeks
15839823|NCT04125732|Biological|AdVEGFXC1|AdVEGFXC1 at one of 4 doses
15839824|NCT04125719|Biological|PVSRIPO|Intralesional injection of PVSRIPO
15839825|NCT04125719|Drug|Nivolumab|Nivolumab infusion
15839826|NCT04125706|Drug|Minocycline Topical|Minocycline will be delivered locally in the periodontal pocket
15839827|NCT04125706|Drug|Metronidazole Topical Gel|Metronidazole will be delivered locally in the periodontal pocket
15839828|NCT04125693|Drug|Rogaratinib (BAY1163877)|Participants will be treated with investigational drug following the treatment schedule and dosing instructions from the feeder-study protocol.
15839829|NCT04125693|Drug|Combination drug|Any other drug specified in the protocol of the completed Bayer clinical trials that is used in combination with rogaratinib. Not all patients receive combination therapy.
15839873|NCT04125186|Other|No other intervention|No other intervention
15839874|NCT04125173|Other|Pneumoperitoneum pressure = 15mmHg|Randomized pneumoperitoneum 1
15839875|NCT04125173|Other|Pneumoperitoneum pressure = 12mm Hg|Randomized pneumoperitoneum 2
15839876|NCT04125173|Other|Pneumoperitoneum pressure = 10mmHg|Randomized pneumoperitoneum 3
15839830|NCT04125680|Behavioral|ESL Health Literacy Classes|The intervention will last 8-weeks, and the first and last classes will be devoted to survey assessments. Participants will be asked to reflect on their health knowledge and behaviors, and how they have changed since starting the program. The curriculum administered during the classes will use pedagogies for health literacy as a practice. It will focus on skills needed to learn about lead exposure in the ESL classroom: (1) vocabulary; (2) grammar; and (3) identifying risk factors, symptoms and preventive strategies. A focus on health literacy as practice will include personal engagement using language in context: (1) role-play interactions about lead exposure prevention; (2) discussing views about risk, and how to talk about it with peers and family members; (3) identifying sources of reliable health information; and (4) learning to ask for support and resources.
15839831|NCT04125654|Device|mNGS for pathogen detection|This assay is a metagenomic test undertaken by BGI Genomics Co., Ltd. for comprehensive detection of viruses, bacteria, fungi, and parasites in clinical samples.
15839832|NCT04125628|Behavioral|Exercise with cooling|The exercise training session involved head cooling and neck wraps. Participants followed a 40-minute continuous cycling where they performed an incremental sub-maximal exercise protocol beginning at 45 W, increasing 10 W every 10 min for a total of four stages on a semirecumbent cycle ergometer in a 20oC room. Before and after the completion of the condition each participant performed a variety of functional ability tests. The evaluation of the core temperature and the assessment of the patient's quality of life also was performed
15839833|NCT04125628|Behavioral|Exercise without cooling|The exercise session performed without cooling. Participants followed a 40-minute continuous cycling where they performed an incremental sub-maximal exercise protocol beginning at 45 W, increasing 10 W every 10 min for a total of four stages on a semirecumbent cycle ergometer in a 20oC room. Before and after the completion of the session each participant performed a variety of functional ability tests. The evaluation of the core temperature and the assessment of the patient's quality of life also was performed.
15839834|NCT04125615|Behavioral|Protected Time Intervention|Participants were assigned two hours of protected, non-clinical time by the chief resident of the service. Chief residents were instructed to assign this time when clinical learning opportunities were lowest. Each participant acted as their own control and was on the intervention phase of the study for the first or last 6 weeks of a quarterly rotation. Residents were concurrently assigned to the same phase of the study (intervention versus control). Participants were not specifically limited in what they could do during their non-clinical time, but they were encouraged to use this time in a way they felt would decrease their own personal burnout and increase their well-being, whether this be performing work-related administrative duties previously done on personal time or fulfilling obligations that are integral to personal health and well-being that can only be completed during normal business hours.
15839835|NCT04125602|Other|High fat low carbohydrate diet|Throughout the 6-day intervention, participants are provided with a high fat, low carbohydrate diet (HF-LCD), including a 3-day diet in which the percentage of fat, protein and carbohydrate is 60%, 15% and 25% respectively while the three macronutrients in the other 3-day diet account for 70%, 15% and 15% respectively. The sequencing of the two diets will be randomized.
15839836|NCT04125602|Other|Low fat high carbohydrate diet|Throughout the 6-day intervention, participants are provided with a low fat, high carbohydrate diet (LF-HCD), including a 3-day diet in which the percentage of fat, protein and carbohydrate is 20%, 15% and 65% respectively while the three macronutrients in the other 3-day diet account for 10%, 15% and 75% respectively. The sequencing of the two diets will be randomized.
15839837|NCT04125589|Behavioral|Speaking Activity|Participants will engage in a speaking activity where they are given a topic to speak about.
15839838|NCT04125589|Behavioral|Talking Activity|Participants will engage in a talking activity where they may talk about a topic of their choice.
15839839|NCT04125576|Diagnostic Test|magnetic resonance imaging(MRI)|magnetic resonance imaging(MRI) will be used to evaluate cerebral blood volume(CBV) of pain network
15839840|NCT04125563|Drug|Capsicum Oleoresin|The soft gel capsules used in the study are easily digested in the stomach and contain standardised doses of 0,4 mg Capsicum oleoresin with the main component capsaicin (8-methyl-N-vanillyl-6-nonenamide) (from chili extract).
15839841|NCT04125563|Drug|Placebos|Soft gel capsules filled with placebo - sorbitol and colorant.
15839842|NCT04125550|Drug|Propofol|2-3 mg/kg propofol will be administered for anesthesia induction. 10 mg/ kg/h propofol infusion will be administered for the maintenance of anesthesia.
15839843|NCT04125550|Drug|Sevoflurane|sevoflurane inhalation (2-8%) will be administered for anesthesia induction. 2% sevoflurane inhalation will be administered for the maintenance of anesthesia.
15839844|NCT04125537|Behavioral|IHI Breakthrough Collaborative Model|Staff participants participate in a quality improvement/collaborative learning model that includes three in-person learning sessions, and three activity sessions during which staff teams at each site use quality improvement processes to implement best practices from the change package. Technical assistance, education, and quality improvement coaching are provided to the site staff teams throughout the project.
15839845|NCT04125524|Diagnostic Test|Terahertz metamaterials|A diagnostic test used to identify specific tumour markers will be carried out on serum samples using terahertz metamaterials.
15839846|NCT04125511|Drug|68Ga-FAPI|Intravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-FAPI. Tracer doses of 68Ga-FAPI will be used to image lesions of IgG4-RD by PET/CT.
15839847|NCT04125498|Other|Osteopathic treatment|Manual treatment that aims to release myofascial tensions
15839848|NCT04125498|Other|Placebo treatment|Similar to OMT without pressure
15839849|NCT04125498|Other|Self-massage|Women will be instructed to perform self-massage at home once a day for 5 minutes.
15839851|NCT04125459|Procedure|Joint Biopsy|a synovial biopsy of a joint that has been affected by a gout attack
15839877|NCT04125160|Device|Continuous glucose monitoring|Continuous glucose monitoring over 16 days
15839878|NCT04125160|Diagnostic Test|Glycaemic markers|Measurement of HbA1c, glycated albumin and fructosamine.
15839879|NCT04125147|Device|Experimental: Montage Bone Hemostat|Use of Montage bone hemostat on the cut surfaces of bone at the osteotomy site
15839880|NCT04125134|Drug|Preservative-free Refresh Optive Advanced Lubricant Eye Drops|over the counter artificial tear
15839881|NCT04125121|Drug|Sevoflurane-propofol|General anaesthesia with a maintenance phase of two hours duration with either sevoflurane or propofol.
15839852|NCT04125433|Behavioral|Peer Integrated Care Services|The project employs a two level intervention to include Peer Support Specialist (PSS) and Community Health Advocate (CHA). Contact and engagement with participating members will be through both direct intervention in the emergency department as well as in the community for prevention visits and follow up. Peers and Community Health Advocates will address Behavioral and Social Determinants of Health (SDoH) concerns through a coordinated intervention supported by a common IT Medicaid member tracking platform. This research project will determine the feasibility of deploying a single shared IT platform that will include referral, appointment completion, and intervention outcome data. Project staff will develop a relationship with the members improving member access and engagement with community-based services. The project will determine the impact on total cost of care through redirecting study participants to community resources rather than return visits to the emergency department.
15839853|NCT04125407|Other|Sensorimotor foot orthoses|The interventional group will receive one customized pair of sensorimotor insoles and will be instructed for their using on a daily bases for the period of 3 months. The duration of using the insoles was established as 1 hour at the day after receiving the insoles. After that, the insoles' tolerance will be assessed based on the email correspondence and further adjustments of insole will be consulted with manufacturer if necessary. Recommended progression in time of using the insoles was established as +1 hour per each day (if possible) with no maximal limit. After 3 weeks, control examination will take place for the control of subjective effect of insoles. Consulting will be offered to the participants through the duration of research. Participants will not undergo any other supplementary treatment (physiotherapy, …) focusing on the flatfoot deformity.
15839854|NCT04125394|Device|hypertonic Sodium chloride (NaCl 5%) eye drops solution in single-dose|Ophthalmic solution of hypertonic sodium chloride (NaCl 5%) without preservatives in single-dose container
15839855|NCT04125381|Other|Exposure to Arsenic by drinking water|People residing in municipalities with Arsenic drinking water concentrations over legal threshold (10 µg/L), were considered as exposed.
15839856|NCT04125368|Behavioral|A&T Interventions|"Intensified counselling on dietary diversity and quality during pregnancy.
~Strengthened government distribution and promotion of IFA supplementation with counseling about its importance, how to manage side effects, and reminders about subsequent supplies.
~Weight-gain monitoring with messaging to mothers about healthy diet and adequate rest; excess weight gain as a danger sign.
~Intensified counseling on importance, benefits, and how-tos of early initiation of breastfeeding and exclusive breastfeeding."
15839857|NCT04125355|Other|Reflexology|Foot reflexology massage for 3 consecutive days and 60 minutes per day.
15839858|NCT04125355|Other|Placebo|Placebo for 3 consecutive days and 60 minutes per day. This intervention only include touch to the foot, it doesn't include deep stimulation.
15839859|NCT04125342|Device|Preventive Conditioned NIV Therapy after planned extubation|Conditioned NIV during 48 hours following extubation.
15839860|NCT04125342|Device|Preventive HFOT after planned extubation|HFOT set according to patients tolerance during 48 hours following extubation
15839861|NCT04125329|Drug|Human umbilical cord mesenchymal stem cells|Human umbilical cord mesenchymal stem cells were given to each diabetic nephropathy subject once a month, peripheral intravenous injection, a total of three times
15839862|NCT04125316|Other|Observation, no intervention|Observational study, no intervnetion
15839863|NCT04125303|Behavioral|brief motivational psychoeducational therapy|The brief motivational psychoeducational therapy (BMPT) it lasted an average of 90 min and followed the following structure: (i) brainstorming the concepts of health, lifestyle, and substance-use prevention; (ii) analysis of a work accident at an international rock group concert, which was used to generate (iii), a debate on consumer habits (30 min); (iv) discussion of the substance types and classifications known by the participants; (v) Prochaska and DiClemente's stages of change and (vi), the consequences of drug use (50 min); and finally, (vii) a true/false quiz used to discuss myths and beliefs about drugs (10 min).
15839864|NCT04125277|Other|FES-PET scan, and possibly one additional visit for an FDG-PET|One visit to either the UMCG or Amsterdam UMC-location VUMC is required for the FES-PET scan, and possibly one additional visit for an FDG-PET. A FES- or FDG-PET scan plus low dose CT will each induce an extra radiation burden of about 6.1 mSv (210 MBq injected for an average patient of 70 kilogram body weight).
15839865|NCT04125264|Device|Intense Therapeutic Ultrasound|Application of 1000 pulses, until 5000 joules (5 joules per pulse), during approximately 15 minutes, with the possibility of 5 minutes rest, depending on the tolerance of the patient.
15839866|NCT04125251|Behavioral|Life Skills Building Training|The Life Skills Building intervention is a curriculum based on 10-12 sessions. The sessions will include the skills essential for family harmony and improving overall mental health of the participants
15839867|NCT04125238|Behavioral|Episodic Future Thinking|Participants will generate descriptions of vivid positive future events.
15839868|NCT04125238|Behavioral|Control Episodic Thinking|Participants will generate descriptions of vivid positive recent past events.
15839869|NCT04125199|Dietary Supplement|supplement consumption|"Composition of the Experimental Product: Concentrated oil of Tridocosahexaenoin-AOX® * (350 mg per capsule), α-tocopherol and coating agent (gelatin). Each capsule is 700 mg, of which 500 mg is oil.
~Placebo composition: Olive oil (each capsule is 700 mg).
~Number of capsules: 6 per day, for any of the two products. The dose taken daily is 2.1 g / day for DHA.
~Supplementation Period: Each group completed two 10-week consumption periods for each of the products, with an intermediate washing period of 4 weeks (28 days)."
15839870|NCT04125186|Diagnostic Test|Baseline EpiNP survey|The survey takes approximately 20 to 30 minutes to complete, and consists of the following: Short Form Health Survey version 2.0 (SF-12v2.0); Lower Urinary Tract Symptoms (LUTS) Tool; Patient Perception of Bladder Condition (PPBC); Self-report Medical History and Current Medication Form; Nocturia Impact Diary (NID); Disease-Specific Healthcare-Seeking Behavior and Treatment; Epworth Sleepiness Questionnaire (ESS); Patient Reported Outcome Measurement Information System Fatigue-Short Form version 1.0 (PROMIS F-SFv1.0); Patient Health Questionnaire (PHQ-8); Work Productivity and Activity Index (WPAI-SHP); Sexual health questions; lifestyle and sociodemographic questions; additionally, only men will complete the International Prostate Symptom Score (IPSS).
15839871|NCT04125186|Diagnostic Test|Bladder diary|It consists of four components: measurement of waist and neck circumference, daily voiding diary (to assess voiding patterns, including frequency, volume, associated urgency, and incontinence episodes over a 24-hour period), NID (to assess nocturia impact), and assessment of morning sleepiness for 3 consecutive days and nights (including the morning of the fourth day).
15839882|NCT04125108|Other|pulmonary rehabilitation|Pulmonary rehabilitation programs were designed to include both 30 minutes resistance and 30 minutes aerobic exercises. Eight basic resistnace exercises were used incorporating, bench press, leg press, leg curl, leg extension, toe raises, biceps curl, triceps curl, shoulder press. Additionally each exercise training session also included aerobic conditioning exercises ona treadmill or cycle ergometer. Aerobic exercise training was carried out 5 days per week, with each session lasting 30 minutes. All exercise sessions were preceded by a 5-minutes warm up period on a treadmill set.
15839883|NCT04125082|Drug|Afrezza Inhalant Product|Participants will be titrated from usual pre-meal insulin plus basal to Afrezza® inhaled insulin plus basal, and will continue on treatment for 14 weeks.
15839884|NCT04125069|Procedure|Coronary Artery Bypass Graft (CABG)|Mitochondrial function will be studied on cardiac tissue collected intraoperatively at the time of placement of the ECC cannulas by the surgeon. Fragments from auricle dissection of the right atrium of the patient will be requalified as sample residues, and will be used immediately by the surgeon to measure mitochondrial respiration (measurement of oxygen consumption by oxygenation and permeability test of the external mitochondrial membrane by the addition of cytochrome C in the oxygen chamber).
15839885|NCT04125056|Drug|Hydronidone Capsule(Specification: 30 mg / grain）|Test group
15839886|NCT04125056|Drug|Hydronidone Capsule(Specification: 15 mg / grain）|Control group
15839887|NCT04125043|Diagnostic Test|Direct ophthalmoscope|Red reflex test
15839888|NCT04125030|Other|Validation of questionnaires|Participants will complete i) the RAS (24 items, 5-point Likert scale), ii) the CM (23 items, 5-point Likert scale), and the iii) the RSA for consumers (32 items, 5-point Likert scale). These participants have already completed these other measures (clinical recovery): iv-Anxiety: Anxiety State-Trait Anxiety Inventory Form Y6 (STAI-Y6) (6 items); v- Depression: Depression Patient Health Questionnaire (PHQ-9) (9 items) ; vi- Alcohol Dependence: Alcohol Use Disorders Identification Test (AUDIT-10) (10 items) ; vii- Drug Dependence: Drug Abuse Screening Test (DAST-10) (10 items) ; viii- Psychosis : Psychosis Screening Questionnaire (PSQ 12 items) ; ix- Social functioning : World Health Organization Disability Assessment Schedule (WHODAS 2.0) (12 items).
15839889|NCT04125017|Device|ICSI with laser pulse|Using laser pulse before ICSI
15839890|NCT04125017|Device|ICSI with micro needle technique|Using micro needle technique before ICSI
15839891|NCT04125004|Device|Samsung Virtual Reality Headset|Patients will pick a game or feature from the virtual reality headset to use during their procedure
15839892|NCT04124991|Drug|Durvalumab|Radioembolization with Yttrium-90 Microspheres
15839893|NCT04124991|Radiation|Radioembolization|Radioembolization with Yttrium-90 Microspheres
15839894|NCT04124978|Device|mandibular advancement device|use of prefabricated adjustable mandibular advancement device to improve OSA
15839895|NCT04124965|Drug|Rozanolixizumab|Rozanolixizumab will be administered by subcutaneous infusion in dosage regimen 1 or 2.
15839896|NCT04124952|Device|Panoptix|Alcon Acrysof(R) Panoptix(R) intraocular lens (IOL)
15839897|NCT04124939|Drug|OnabotulinumtoxinA 100 UNT|"BOTOX for injection is an acetylcholine release inhibitor and a neuromuscular blocking agent indicated for:
~• Treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and frequency, in adults who have an inadequate response to or are intolerant of an anticholinergic medication."
15839898|NCT04124926|Drug|Vonoprazan|Over-encapsulated tablet administered orally with approximately 240 mL water, 30 minutes prior to the morning meal.
15839899|NCT04124926|Drug|Lansoprazole|Over-encapsulated capsule administered orally with approximately 240 mL water, 30 minutes prior to the morning meal.
15839900|NCT04124913|Drug|Dydrogesterone 10 MG Oral Tablet|Oral dydrogesterone 10 mg tablet three times a day for luteal phase support
15839901|NCT04124913|Drug|Progesterone Vaginal Gel [Crinone]|Vaginal progesterone gel 90 mg once a day for luteal phase support
15839902|NCT04124887|Drug|Sodium Fluoride|Sodium Fluoride varnish was applied to the targeted teeth at baseline, one and three months.
15839903|NCT04124887|Drug|Tricalcium Phosphate|Varnish with Tricalcium Phosphate was applied to the targeted teeth at baseline, one and three months.
15839904|NCT04124887|Drug|Xylitol-coated calcium and phosphate|Varnish with Xylitol-coated calcium and phosphate was applied to the targeted teeth at baseline, one and three months.
15839905|NCT04124887|Drug|Casein phosphopeptide amorphous calcium phosphate|Varnish with Casein phosphopeptide amorphous calcium phosphate was applied to the targeted teeth at baseline, one and three months.
15839906|NCT04124874|Other|There will be no intervention|There will be no intervention
15839907|NCT04124861|Drug|Drug free, IS monotherapy and GC combined with IS|Follow-up intervals: Every 3 months (3th, 6th, 9th, 12th, 15th, 18th month).
15839908|NCT04124835|Other|Swiss Ball|"Top narrow (DeLee Plan -5 to -1 or Hodge Plan 1-3) Retroversion, lateralization and pelvic circumference exercises with abducted hips and external rotation will be encouraged. Exercises according to fetal positioning: Four ball-assisted supports and / or biped stance with anterior trunk inclination with asymmetrical opening of lower limbs with the aid of the ball. The hips will be in abduction and external rotation.
~Lower Narrow (DeLee Plan +1 to +5 or Hodge Plan 3-4) Pelvic anteversion, tilt, and circumference exercises with abducted hips and internal rotation will be encouraged. Exercises according to fetal positioning: Four ball-assisted supports and / or biped stance with anterior trunk inclination with asymmetrical opening of lower limbs with the aid of the ball. The hips will be in abduction and internal rotation."
15839909|NCT04124835|Other|Control Grup|Habitual Care of the Service.
15839910|NCT04124822|Drug|Piroxicam 20 mg|Piroxicm is from oxicam family of anti inflammatory drug that inhibits prostaglandin synthesis and effectively lower pain threshold levels
15839911|NCT04124822|Drug|prednisolone 20 mg|prednisolone is from steroid family of anti inflammatory drug that inhibit arachidonic acid and effectively lowers the pain
15839912|NCT04124809|Device|laser assisted collapse|Apply 1-2 pulses of laser using the Saturn between 2 adjacent trophectoderm cells away from the inner cell mass in the blastocysts
15839913|NCT04124796|Other|Semi-structured interviews|Based on an interview grid previously built, the interviews will investigate the factors governing the decision to consult and methods of intervention to reduce the time to consult.
15839914|NCT04124783|Device|Cooling Bolero|A vest filled with a new material (not ice or a gel) that provides controlled cooling by absorbing heat
15839915|NCT04124770|Other|Movement|Re-positioning of neck
15839916|NCT04124757|Other|Deep neuromuscular block|Deep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count
15839917|NCT04124744|Other|Health Champions intervention|Health Champions are trained volunteers who will support service users with their physical health goals over 9 months, meeting once a week
15839918|NCT04124744|Other|Control group-treatment as usual|Participants will receive treatment as usual from their Community Mental Health Team
15839919|NCT04124731|Drug|sintilimab plus anlotinib|Sintilimab 200 mg administered intravenously (IV) on Day 1 of each 21-day cycle plus anlotinib capsules 12 mg given orally in fasting conditions, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21
15839920|NCT04124731|Drug|Chemotherapy|"Pemetrexed combined with platinum regimen (non-squamous cell carcinoma): pemetrexed 500mg/m2, intravenous infusion on the first day of each cycle, cisplatin 75mg/m2 or carboplatin AUC 5, intravenous infusion on the first day of each cycle, 1 cycle every 3 weeks (Q3W), 4 cycles in total. Patients who did not progress after 4 cycles received maintenance monotherapy with pemetrexide at the same dose as before.
~Gemcitabine combined with platinum regimen (squamous cell carcinoma): gemcitabine 1250mg/m2, intravenous infusion on day 1 and day 8 of each cycle, cisplatin: 75mg/m2 or carboplatin: AUC 5, intravenous infusion on day 1 of each cycle, 1 cycle every 3 weeks (Q3W), 4-6 cycles in total."
15839921|NCT04124718|Genetic|high caries experience|DNAs were obtained from epithelial cells in buccal mucosa and were extracted with Genomic DNA Isolation Kit
15839922|NCT04124705|Drug|Armour® Thyroid|Oral administration once daily
15839923|NCT04124705|Drug|Synthetic T4|Oral administration once daily
15839924|NCT04124692|Device|Sculptra Aesthetic new dilution|Treatment of cheek wrinkles
15839925|NCT04124679|Other|Transcutaneous Electrical Acupoint Stimulation|patients received Transcutaneous Electrical Acupoint Stimulation for 30 mins on the acupoints
15839926|NCT04124666|Biological|Granulocytes|Granulocytes cross-matched for ABO-Rh and CMV; bioactivity of anti-cancer ability meets the criteria.
15839927|NCT04124653|Drug|PF-06842874|Single dose administration of PF-06842874
15839928|NCT04124653|Drug|Placebo|Single dose administration of placebo
15839929|NCT04124653|Drug|Relative Bioavailability|Relative bioavailability assessment of modified-release formulation
15839930|NCT04124640|Other|Patients' data (baseline characteristics, clinical and outcomes) from routine care visits|Use of a standardized scale to collect clinical and patient-centered data, to assess the effectiveness of Libicare in real life in female 45-65 years old. Patients' data (baseline characteristics, clinical and outcomes) will be collected according to sites routine care.
15839931|NCT04124627|Procedure|Ultrasound guidance in addition to radiographic guidance|Patients that will be operated will receive ultrasound guidance in addition to radiographic guidance, that is gold standard
15839932|NCT04124614|Drug|Brexpiprazole|Up to 3 mg pill
15839933|NCT04124614|Drug|Sertraline|Up to 150 mg pill
15839934|NCT04124614|Other|Placebo|Pill
15839935|NCT04124601|Radiation|Chemoradiotherapy|Capecitabine tablet with fractionated radiotherapy
15839936|NCT04124601|Drug|Ipilimumab|Infusion
15839937|NCT04124601|Drug|Nivolumab|Infusion
15839938|NCT04124588|Device|Nexpowder (Hemostatic powder)|Nexpowder generates gelation-effects when the powder comes into contact with water, forms a physical barrier to control hemorrhage, preserve ulcer sites and thereby demonstrates its effective hemostatic performance. Hydrogels, which turned into gel-formation through water contacts in the gastrointestinal tract protect the wound sites for over 24 hours, are subsequently detached from the lesion, and completely excreted from the patient body system within 3 days.
15839939|NCT04124588|Device|Conventional Technique|Argon Plasma Coagulation, Coagulation including Forcep, Hemoclipping, Band Ligation, Epinephrine or Absolute Alcohol Injecction can be used as standard-of-care hemostatic treatment(s).
15839940|NCT04124562|Other|Nitrous Oxide|Nitrous Oxide use ratio in Turkey's hospitals
15839941|NCT04124549|Other|Usual care with sham intervention|Patients in the control group received usual care and were advised to do sham exercise such as stretch legs and arms about 15 minutes during the first 2 HD hours.
15839942|NCT04124549|Other|Intradialytic Combined Exercise|Each session consisted of a 5-minute warm-up, cool-down and 30-minute cycling at a Rating of Perceived Exertion (RPE) of 12-14. The machine has two exercise types including aerobic exercise and resistance exercise. Patients were asked to perform aerobic exercise 20-min and resistance exercise 10-min in the first stage. Every four weeks is divided into a stage. And the time of aerobic exercise and resistance exercise were personally adjusted per stage to maintain the personalized target RPE. In the following stages, aerobic exercise was continued 15-min for the second stage, 10-min for the third and the forth stage, 15-min for the fifth stage and 20-min for the last stage. And the time for resistance exercise was adjusted for the total exercise time. The resistance of exercise also progressive increased in order to adapt the target RPE. It was accessible to patients of different ages, gender, cultures and ethnicities.
15839943|NCT04124536|Behavioral|HIV self-testing with partner notification.|HIV self-test kits are oral swabs. Partner notification will be offered to all women in the intervention arm, regardless of HIV status.
15839944|NCT04124510|Drug|Brand Name: Flutiform K-haler|Brand Name: Flutiform K-haler Generic name: Fluticasone/formoterol dosage form: oral inhalation
15839945|NCT04124497|Drug|Daratumumab|"Daratumumab 16 mg/kg intravenously at following schedule:
~cycle 1 and 2: days 1, 8, 15, and 22
~cycle 3 through 6: days 1, and 15
~from cycle 7 until disease progression: day 1."
15839946|NCT04124497|Drug|Pomalidomide|4 mg once daily on days 1-21
15839947|NCT04124497|Drug|Dexamethasone|Oral or intravenous dexamethasone 40 mg/day (≤ 75 years old) or 20 mg/ day (>75 years old) on days 1, 8, 15 and 22
15839948|NCT04124484|Drug|DBPR108 tablet(50mg), Placebo matching DBPR108 tablet(100mg)|One DBPR108 tablet(50mg) administered orally once a day + Two Placebos matching DBPR108 tablet(100mg) administered orally once a day for 12 weeks
15839949|NCT04124484|Drug|DBPR108 tablet(100mg), Placebo matching DBPR108 tablet(50mg), Placebo matching DBPR108 tablet(100mg)|One DBPR108 tablet(100mg) administered orally once a day + One Placebo matching DBPR108 tablet(100mg) administered orally once a day + One Placebo matching DBPR108 tablet(50mg) administered orally once a day for 12 weeks
15839950|NCT04124484|Drug|DBPR108 tablet(100mg), Placebo matching DBPR108 tablet(50mg)|Two DBPR108 tablets(100mg) administered orally once a day + One Placebo matching DBPR108 tablet(50mg) administered orally once a day for 12 weeks
15839951|NCT04124484|Drug|Placebo matching DBPR108 tablet(100mg), Placebo matching DBPR108 tablet(50mg)|Two Placebos matching DBPR108 tablet(100mg) administered orally once a day + One Placebo matching DBPR108 tablet(50mg) administered orally once a day for 12 weeks
15839953|NCT04124458|Device|Radiofrequency ablation|In radiofrequency ablation arm, sensory brunch of occipital nerve will be burn with max allowable temperature: 42 degrees Celsius, real temperature: 41 degrees Celsius, power=65 volts, two cycles of 180 second.
15839954|NCT04124445|Procedure|Pulsed Radiofrequency Ablation|"Radiofrequency ablation, also called rhizotomy, is a nonsurgical, minimally invasive procedure that uses heat to reduce or stop the transmission of pain. Radiofrequency waves ablate, or burn, the nerve that is causing the pain, essentially eliminating the transmission of pain signals to the brain."
15839955|NCT04124432|Drug|Cannabis|Cannabis will be smoked
15839956|NCT04124432|Drug|Nicotine|Nicotine will be smoked or vaporized
15839957|NCT04124419|Device|Treatment with Evolve System|EMS and RF Treatment
15839958|NCT04124406|Device|Cologuard|multi-target stool Deoxyribonucleic Acid (MT-sDNA) screening test
15839959|NCT04124393|Procedure|Colon Polypectomy|Polyp search and resection will be performed entirely during the withdrawal phase in both WE and CO2 groups. Insertion inspection and polypectomy will not be performed. All polyps in the proximal colon, defined as cecum, ascending colon, hepatic flexure, and transverse colon, will be removed irrespective of their size and appearance.
15839960|NCT04124380|Behavioral|Imaginal Exposure|Six 50 min, twice weekly video telehealth sessions will be provided based on prolonged exposure therapy for PTSD. This brief intervention includes psycho-education and focuses on imaginal exposure only based on Zoellner et al., (2016).
15839961|NCT04124380|Behavioral|Alcohol Skills Training|Six 50 min, twice weekly video telehealth sessions will be provided based on content from the alcohol skills training program and CBT protocols. Each session includes teaching skills and practice, focusing on mitigating rewarding aspects of alcohol, addressing cravings, and increasing other natural rewards.
15839962|NCT04124380|Behavioral|Supportive Telehealth|The supportive counseling intervention, modeled after Litz et al. (2007), will ask participants to self-monitor their experience of weekly symptoms and complete weekly online writing about daily non-trauma related concerns and hassles. Participants will talk with a therapist on the telephone twice per week.
15839963|NCT04124367|Drug|Cerebrolysin|30 ml once daily (+70 ml 0.9% saline)
15839964|NCT04124367|Device|non-invasive brain stimulation|2 mA/35 cm² for 2x20 minutes, once daily
15839965|NCT04124367|Drug|Placebo|100 ml once daily 0.9% saline
15839966|NCT04124367|Device|sham intervention|0 mA/35 cm² for 2x20 minutes, once daily Run-in phase consisting of ramp-up (10 seconds), stimulation (10 seconds), and ramp-down (10 seconds).
15839967|NCT04124354|Behavioral|Physical Activity|Participants will attend 3 treadmill walking sessions/week for 8 weeks (24 total)-exercising at 60-75% of their heart rate (HR) reserve monitored using Polar FT1 HR monitors. All walking sessions will take place using treadmills within the West Bank Office Building on the UMN-Twin Cities campus. Each walking session will be 30 min long during intervention weeks 1-4 and 45 min each during weeks 5-8. This exercise dose is equivalent to that employed in the only two human studies of exercise and the gut microbiome in addition to the dosage observed necessary to yield meaningful cardiometabolic changes. After the 4th- and 8th-weeks of the intervention, participants in both study groups will again undergo outcome assessments
15839968|NCT04124341|Device|Epidural Prefrontal Cortical Stimulation (EpCS)|Prior to surgery, subjects will undergo a high resolution structural scan to identify anatomical landmarks for rostral anterior and lateral prefrontal cortex. Following identification of target areas, EpCS quad leads will be projected over the anterior and lateral prefrontal cortex.Subjects will be kept in the hospital for a minimum of 72 hours for observation during which the investigators will obtain a high resolution spiral CT scan without contrast to confirm lead placements post- operatively and rule out any intra-cranial bleeds. Patients will receive analgesics which they may continue as an outpatient on as needed basis. During this 2-3 weeks recovery period, the attention to pain control and mood is critical. The research team will contact patients at least twice per week to check on their status.
15839969|NCT04124328|Procedure|ALINE + VoM infusion|In patients assigned to the ALINE + VoM infusion group, extended ablation will be performed according to the ALINE criteria. Additionally, the vein of Marshall will be infused with ethanol.
15839970|NCT04124328|Procedure|ALINE only|In patients assigned to the ALINE only, extended ablation will be performed according to the ALINE criteria.
15839971|NCT04124315|Other|Accelerometry|Patients will be given accelerometers at this visit and informed on how to use them (e.g., wear on the ankle during waking hours, upright, etc).
15839972|NCT04124315|Other|Daynamica app|Participants will be asked to record location/activity on the app in order to characterize activity patterns both inside and outside of the hospital SET setting.
15839973|NCT04124302|Drug|Insulin Glulisine|A kind of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial.
15839974|NCT04124302|Drug|Insulin Aspart|A kind of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial.
15839975|NCT04124302|Drug|Insulin Lispro|A kind of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial.
15839976|NCT04124289|Other|Pain measurement using 3 scales|Patients will assess their pain after surgery using three different pain scales.
15839977|NCT04124276|Dietary Supplement|Lycium barbarum polysaccharide|Experimental groups take Lycium barbarum polysaccharide (LBP) (300mg/day) for 6 weeks
15839978|NCT04124276|Dietary Supplement|Placebo|Placebo control group takes placebo (300mg/day) for 6 weeks.
15839979|NCT04124263|Other|Educational short message texts|Educational messages for patient engagement
15839980|NCT04124263|Other|Adherence short message texts|Reminder messages of medication use time
15839981|NCT04124250|Other|Observational|Mass Drug Administration with a single co-administered dose of Ivermectin, DEC and Albendazole performed by Provincial and National Health Departments annually for two years
15839982|NCT04124224|Other|Unidos|The investigators will collaborate with our community partners to implement and evaluate a Community-Clinical Linkage (CCL) model in which Community Health Workers (CHWs) connect individuals to social determinant and community health services and build sociocultural resilience through CHW-facilitated individual and group support. As a public health practice-based study that incorporates evidence-based strategies, the investigators seek to establish Unidos effectiveness in Arizona counties with the highest percentage of Latinos of Mexican origin (Yuma, Pima, Santa Cruz, and Maricopa). Unidos CHWs, based in local health departments, will use evidence-based strategies to address three elements that are important in addressing chronic disease risk: 1) health promotion resources and programs; 2) individual and group-based social support; and 3) leveraging community resources to address social determinants of health.
15839983|NCT04124211|Biological|Fecal Microbiota Transplantation (FMT)|FMT will be performed through transendoscopic enteral tubing (TET) within one week during treatment period
15839984|NCT04124198|Radiation|Intensity-Modulated Radiation Therapy (IMRT)|Accelerated or hyper-fractionated radiotherapy
15839985|NCT04124198|Drug|Cisplatin|Concurrent weekly cisplatin 40 mg/sqm to fit patients
15839986|NCT04124198|Drug|Nimorazole.|Concurrent nimorazole
15839987|NCT04124198|Procedure|Transoral Robotic Surgery (TORS) with neck dissection|Robotic-assisted resection of the primary oropharyngeal tumour and ipsilateral selected neck dissection of lymph node levels II-IV. Patients with a primary base of tongue cancer or with significant involvement of tongue base or the soft palate defined as above 1 cm, will be offered a bilateral neck dissection of levels II-IV.
15839988|NCT04124185|Diagnostic Test|Ocular assessments|Complete ocular examination, Axial length and corneal curvature, Optical Coherence Tomography, Visual acuity, Contrast sensitivity
15839989|NCT04124172|Device|Real rTMS (Magstim)|See arm description
15839990|NCT04124172|Device|Sham rTMS|See arm description
15839991|NCT04124146|Radiation|MRI for some patients according functionnal tests results|Depending on the results obtained on the evaluation criteria, additional examinations could be prescribed (imaging) for subjects with an unsatisfactory functional score. There is therefore a potential change in the usual care.
15839992|NCT04124133|Device|dressing with hyaluronic acid|Application of ialuset cream or gauzepad (hyaluronic acid)
15839995|NCT04124107|Device|multiparametric MRI and 68Ga-PSMA PET/MRI|All participants will undergo multiparametric MRI examination. If mpMRI is unfavorable for prostate cancer, participants will undergo 68Ga-PSMA PET/MRI examination
15839996|NCT04124107|Procedure|Prostate biopsy|Participants with unfavorable mpMRI but favorable 68Ga-PSMA PET/MRI will undergo both 68Ga-PSMA PET/MRI-ultrasound-fusion targeted biopsy and transperineal ultrasound guided 12-core systematic biopsy
15839997|NCT04124094|Drug|Test Product (Fluticasone propionate and salmeterol xinafoate inhalation powder/Respirent Pharmaceuticals)|Fluticasone propionate 100 mcg and salmeterol xinafoate 50 mcg inhalation powder/Respirent Pharmaceuticals
15839998|NCT04124094|Drug|Reference Product (SERETIDE DISKUS® 100/50 inhalation powder/GSK)|2 inhalations in one study period
15839999|NCT04124094|Other|Activated Charcoal suspension|oral suspension before and after inhalation of study Investigational Products
15840000|NCT04124081|Drug|Hydronidone capsules& Entecavir capsules|take the Hydronidone capsule and then the entecavir capsule, and then take the last two together
15840001|NCT04124068|Other|Hydrogen peroxide teeth whitening gel|Hydrogen peroxide teeth whitening gel with concentrations ranging between 6% - 30%
15840002|NCT04124068|Device|GLO Brilliant Teeth Whitening Device|Intra-oral mouthpiece connected to a battery in order to generate light and heat to effect the whitening treatment.
15840003|NCT04124068|Device|GLO Lit Teeth Whitening Device|Intra-oral mouthpiece connected to a battery in order to generate light and heat to effect the whitening treatment.
15840004|NCT04124068|Device|GLO Science Professional Teeth Whitening Device|Intra-oral mouthpiece connected to a battery in order to generate light and heat to effect the whitening treatment.
15840005|NCT04124055|Diagnostic Test|Therapeutic drug monitoring (TDM)|Saliva and dried blood spot samples are collected. Based on the measured drug concentration the dose can be adjusted
15840007|NCT04124029|Device|No Intervention is used for this study but all subjects will be asked to complete EEG testing and an MRI scan.|No intervention will be used.
15840008|NCT04124029|Procedure|No intervention is used for this study but all subjects will be asked to complete a venous blood draw procedure and a lumbar puncture procedure.|No intervention will be used.
15840009|NCT04124016|Dietary Supplement|Inulin|Powder of inulin fractions dissolved into 250 ml of water
15840010|NCT04124016|Dietary Supplement|green tea extract|Powder of green tea extract dissolved into 200 ml of water
15840011|NCT04124016|Dietary Supplement|grape seed|Powder of grape seed extract (rich in di-hydroxylated flavan-3-ol monomers) dissolved into 200 ml of water
15840012|NCT04124016|Dietary Supplement|grape seed extract|Powder of grape seed extract (rich in di-hydroxylated flavan-3-ol oligomers) dissolved into 200 ml of water
15840013|NCT04124003|Drug|rosuvastatin|Specified dose on specified days
15840014|NCT04124003|Drug|BMS-963272|Specified dose on specified days
15840015|NCT04123990|Diagnostic Test|Iron status testing|Iron status testing
15840077|NCT04123444|Drug|Isotonic saline|Continuously infusion for 72 hours.
15840078|NCT04123431|Device|Total Hip Replacement|Primary elective total hip replacement
15840079|NCT04123418|Biological|WVT078|WVT078 will be administered IV (intravenously) in a dose escalation schedule
15840080|NCT04123418|Drug|WHG626|WHG626 will be administered orally in a dose escalation schedule
15840016|NCT04123951|Other|Home-based Exercise|Patients in the home-based exercise arm will complete a 12 week home-based aerobic and resistance exercise training programme. There will be a 2 week period prior to this in which patients will complete up to 6 supervised sessions in order to learn about the home-based exercise training. There will be a 4 week return visit and an optional 8 week return visit in order to reassess fitness and aid the patients with any questions or queries they may have and to aid them in progressing their exercise.
15840017|NCT04123938|Other|Pea Protein|Soluble pea protein
15840018|NCT04123938|Other|Whey Protein|Whey protein concentrate
15840019|NCT04123938|Other|Maltodextrin|Non-protein isocaloric comparator
15840020|NCT04123925|Drug|Nivolumab|Locally advanced colon cancer must be documented at screening (within 21 days prior to initiation of study treatment) and re-assessed prior surgery by spiral or multidetector computed tomography (CT) scan Postoperatively, standard adjuvant chemotherapy will be administered in pathological III-stage and at investigator discretion in pathological II-stage at high risk
15840021|NCT04123912|Behavioral|Kinesio Taping - Functional Movement Power Training|Subjects assigned to the Kinesio Taping - Functional Movement Power Training (KT-FMPT) group will receive FMPT concurrent with KT. The FMPT protocol was developed by the research team with reference to common physiotherapeutic exercises for children with motor disabilities.9 It comprises 5 functional movement exercises and 6 lower-limb power/resistance training exercises using weights or resistance bands.
15840022|NCT04123912|Behavioral|Jogging with placebo taping|Subjects assigned to the control group will receive no FMPT or KT, but participate in a jogging intervention with placebo tape applied on their calf muscles and removed after the intervention.
15840023|NCT04123899|Drug|IGAD→GSTD|"Drug: IGAD First Period: Single oral administration of 1 tablet of Gaster®D Tab 20mg (Famotidine) (Unchanged Manufacturer, Announced Reference Drug)
~Other: Washout period 7 days
~Drug: GSTD Second Period: Single oral administration of 1 tablet of Gaster®D Tab20mg (Famotidine) (Changed Manufacturer)"
15840024|NCT04123899|Drug|GSTD→IGAD|"Drug: GSTD First Period: Single oral administration of 1 tablet of Gaster®D Tab20mg (Famotidine) (Changed Manufacturer)
~Other: Washout period 7 days
~Drug: IGAD Second Period: Single oral administration of 1 tablet of Gaster®D Tab 20mg (Famotidine) (Unchanged Manufacturer, Announced Reference Drug)"
15840025|NCT04123886|Drug|SCB-313|SCB-313 Intrapleural injection, once daily. Single dose on Day 1 in Cycle 0 followed by 7-day safety assessment, then dose on Day 1,2,3 in Cycle 1 followed by 21-day observation .
15840026|NCT04123873|Drug|Paracetamol|1g x 4 p.o.
15840027|NCT04123873|Drug|Ibuprofen (400 mg x 4)|400mg x 4 p.o.
15840028|NCT04123873|Drug|Dexamethasone|24mg IV x 1 after induction om anaesthesia
15840029|NCT04123873|Drug|Placebo oral tablet (x 4)|p.o. x 4
15840030|NCT04123873|Drug|Placebo IV (x 1)|IV x 1
15840031|NCT04123860|Other|ultrasonic hydrodynamic maxillary sinus lift buccal pad fat|ultrasonic hydrodynamic maxillary sinus lift and buccal fat pad as grafting material followed by immediate implant
15840032|NCT04123860|Other|ultrasonic hydrodynamic maxillary sinus lift platelet rich fibrin|ultrasonic hydrodynamic maxillary sinus lift and platelet rich fibrin as grafting material followed by immediate implant
15840033|NCT04123847|Other|Standing and Stepping|Participants will have at least 80 sessions of stand and step training with the assistance of trainers over-ground, or in a harness on a body weight supported treadmill.
15840034|NCT04123847|Device|Standing, Stepping and Voluntary Movement with spinal cord Epidural Stimulation|Participants will be have at least 80 sessions of stand and step training with epidural stimulation, with the assistance of trainers over-ground, or in a harness on a body weight supported treadmill. Voluntary movement with epidural stimulation will be completed in the supine or seated position.
15840035|NCT04123834|Procedure|Patella tendon & bone block autograft + press-fit femoral technique|Implantless Arthroscopic ACL reconstruction using press-fit femoral technique The investigator's study uses the press-fit graft fixation technique by Edgar Michael. A midline skin incision was made that extends from inferior pole of patella up to anterior tibial tuberosity. Patella tendon with tibial tuberosity bone block were harvested, patella bone was left intact. The tendon was fixed together with non-absorbable suture.
15840036|NCT04123834|Procedure|Arthroscopic ACL reconstruction|Arthroscopic ACL reconstruction with implant (using hamstring autograft fixed with bioscrew and endo-button)
15840037|NCT04123834|Device|Hamstring tendon autograft + implant fixation|Arthroscopic ACL reconstruction with implant (using hamstring tendon autograft fixed with bioscrew and endo-button)
15840038|NCT04123821|Device|Nasopharyngeal airway|A disposable nasopharyngeal airway of appropriate size will be selected for patients allocated to the intervention group with 5L/min oxygen through nasal cannula
15840039|NCT04123808|Device|IpsiHand Treatment|The IpsiHand system utilizes a Brain-Computer Interface (BCI) as a control for a robotic hand orthosis donned on the affected upper extremity as participants are guided through a rehabilitation program on a tablet. Participants will complete 16-32 weeks of home therapy with the IpsiHand system. Motor function of their impaired upper extremity will be evaluated at baseline, at 4-week intervals, and 3 months post no-device use, to track progress.
15840040|NCT04123795|Drug|Certolizumab pegol|"Certolizumab Pegol
~Pharmaceutical Form: Solution for injection in pre-filled syringe
~Route of Administration: Subcutaneous use
~Other Names:
~Cimzia
~CDP870
~CZP"
15840041|NCT04123795|Drug|Placebo|"Placebo
~Pharmaceutical Form: Solution for injection in pre-filled syringe
~Route of Administration: Subcutaneous use
~Other Names:
~-PBO"
15840042|NCT04123782|Device|F-ESW Treatment|The biological principles on which is based Focused Shockwave Treatment (F-ESWT) is has been demonstrated mostly in terms of improvement of Platelet Derived Growth Factor (PDGF), Vascular Endothelial Growth Factor (VEGF), Fibroblast Growth Factor (FGF), Insulin Growth Factor-1 (IGF-1) and Transforming Growth Factor b1 (TGF-b1).
15840043|NCT04123782|Device|Placebo F-ESW Treatment|Very low concentration of F-ESW.
15840044|NCT04123769|Drug|Hydronidone|First take Hydronidone capsule, single-dose and then Multiple-dose
15840045|NCT04123756|Behavioral|standardized exercise therapy for knee OA patients|Standardized exercise therapy for 6-8 weeks (two times per week).
15840046|NCT04123743|Drug|Trigonella foenum-graceum extract topical cream|Topical cream containing Trigonella foenum-graceum extract
15840047|NCT04123743|Other|Facial Wash|Wardah brand facial wash
15840048|NCT04123743|Other|Sunscreen Cream|Parasol sunscreen cream SPF 33
15840049|NCT04123743|Other|Placebo|Placebo topical cream
15840050|NCT04123730|Other|Fixed-dose compared to variable oxygen flow supplementation during walking|"At day 1 the patients will perform Walk A and Walk B in a random order:
~Walk A: The patients will perform a Endurance Shuttle Walk Tests (ESWT) with the fixed-dose (FOT). O2matic will monitor pulse rate and saturation continuously during the test.
~Walk B: The patients will perform a Endurance Shuttle Walk Tests (ESWT) with a variable oxygen flow (AOT) depending on the saturation. O2matic will monitor pulse rate and saturation continuously during the test, and adjust oxygen flow depending on the saturation.
~At day 2 the patients will perform two 6 minutes walking (MWT) test in random order:
~Walk C: A 6 MWT with FOT Walk D; A 6 MWT with AOT"
15840051|NCT04123717|Drug|Intravenous Ibuprofen|The treatment phase consists of assignment to a study arm, either IV Ibuprofen, IV Paracetamol, IV paracetamol-Ibuprofen, or PO ibuprofen, and administration of the appropriate medication. The IV medications will be administered over a 15-minute period. The safety of infusion of IVIbuprofen in just 10 minutes has been established, and to infuse over 15 minutes to ensure that IV Paracetamol and IV Ibuprofen have equal infusion times. For IV paracetamol-Ibuprofen, the IV paracetamol-Ibuprofen will be administered as a sequential infusion of IV Ibuprofen over 15 minutes, followed by a flush of the IV line, followed immediately by IV paracetamol infusion over 15 minutes. Oral ibuprofen will be administered as a syrup or tablet based on patient weight and parental preference.
15840052|NCT04123704|Drug|Sitravatinib|sitravatinib capsule
15840053|NCT04123691|Device|pulse oximetry monitoring|pulse oximetry monitoring as per routine clinical practice
15840054|NCT04123678|Device|Deep Ensemble for the Recognition of Malignancy (DERM)|AI-based decision support tool
15840055|NCT04123665|Drug|Stannous fluoride|In this arm, participants will apply a full ribbon of dentifrice ( 0.454% w/w stannous fluoride) to the bristles of a study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) and record on their study diary completed brushings.
15840056|NCT04123665|Drug|Sodium monofluorophosphate|In this arm, participants will apply a full ribbon of negative control dentifrice (1000 ppm fluoride as SMFP to the bristles of a study toothbrush and brush their teeth in their usual manner for one timed minute twice daily (morning and evening) and record on their study diary completed brushings.
15840057|NCT04123652|Drug|Lidocaine Hydrochloride 2% Intravenous Solution, DIN 02421992|"An intravenous will be started. • Lidocaine - initial dose of 5.0 mg/kg +/- 1.0 mg/kg (based on actual weight, up to maximum dose 600 mg) over 45 minutes, followed by increases of 0.5 mg/kg each infusion based on tolerability of side effects, not to exceed 7 mg/kg or 600 mg.
~• Ketamine - initial dose of 0.1 mg/kg (based on actual weight) over 45 minutes (rounded to nearest 5 mg, up to maximum 15 mg), increased by 0.1 mg/kg (rounded to nearest 5 mg) each infusion based on tolerability of side effects During the infusion patient will be monitored by another MD for BP, PR, PO2. Patients will not be allowed to drive for 24 hours."
15840058|NCT04123639|Procedure|PTA|Percutaneous transluminal angioplasty
15840059|NCT04123626|Drug|QR-1123|unilateral IVT injection
15840060|NCT04123626|Other|Sham procedure|Sham procedures (i.e. no penetration of the globe) closely mimic the active injection and serve to mask subjects to treatment assignment
15840061|NCT04123613|Drug|DM199|A pharmaceutical formulation comprised of recombinant human tissue kallikrein-1 (rhKLK-1) that is being developed as an injectable protein drug
15840062|NCT04123600|Device|Origin Stem and Logical Cup|The Origin Stem is a straight, tapered, HA coated cementless femoral stem, and the Logical Cup is a porous coated acetabular cup mated with a cross-linked polyethylene liner. The components are used as part of a total joint replacement prosthesis.
15840063|NCT04123587|Drug|discontinuation of Sulfonylureas|"Discontinuation of sulfonylurea, alternative drug administration.
~If there is a significant increase in blood glucose, it is considered as a sulfonylurea-dependent patient. Discontinue the alternative drug and resume the sulfonylurea, and monitor for 12 weeks or until stabilization of blood glucose at short intervals.
~if blood glucose levels are within optimal range after replacement of sulfonylureas with other agents, the patient is regard as non-SU-dependent"
15840064|NCT04123574|Drug|Talabostat Mesylate|"BXCL701 tablets dosage strengths include 0.2mg and 0.05mg tablets for oral administration.
~Patients are to self-administer the prescribed number of BXCL701 tablets for a total daily dose of 0.6 mg. BXCL701 should not be taken on an empty stomach.
~Daily blood pressure monitoring will be performed during the dosing period. Administration of at least 1L of intravenous (IV) fluids is required on Day 1.
~On days when pharmacokinetic (PK) assessments are being performed, BXCL701 should be administered at the study center and should be administered at (approximately) the same time of day on each treatment day."
15840065|NCT04123561|Drug|TLC599|TLC599 is a proprietary (Bioseizer) lipid formulation containing DSP (active ingredient)
15840066|NCT04123561|Drug|DSP|Dexamethasone sodium phosphate (DSP) is a glucocorticoid widely used in the treatment of joint pain such as gout, osteoarthritis and rheumatoid arthritis via IA injection.
15840067|NCT04123561|Other|Normal Saline|0.9% normal saline
15840068|NCT04123548|Biological|StrataGraft skin tissue|StrataGraft skin tissue is delivered as a single topical application to no more than 3 separate burn sites, totaling up to approximately 1000 cm^2 of treatment area using no more than 10 tissues.
15840069|NCT04123535|Device|ExAblate 2000/2100 Magnetic Resonance-guided Focused Ultrasound (MRgFUS)|The ExAblate 2100 MRgFUS system (InSightec, Inc., Dallas, Texas, USA) is a noninvasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue and bone.14-16 The ExAblate combines a focused ultrasound surgery (FUS) delivery system and a conventional diagnostic 3T Magnetic Resonance (MR) scanner. The ExAblate systems provide a real-time therapy planning algorithm, thermal dosimetry, and closed-loop therapy control. The ExAblate transducer device is an integrated component of the MR table
15840070|NCT04123522|Procedure|anterior approach|anterior approach
15840071|NCT04123522|Procedure|posterior appraoch|posteiror appraoch
15840072|NCT04123496|Device|rTMS|Device: Repetitive Transcranial Magnetic Stimulation (rTMS) MagVenture MagPro TMS System would be utilized to deliver 3-minute sessions of intermittent theta burst to left dorsolateral prefrontal cortex.
15840073|NCT04123483|Drug|EnBrace HR Softgel|Prescription folate prenatal supplement with other dietary ingredients; one multiphasic soft gelatin capsule 1x/day for 8 week study
15840074|NCT04123470|Genetic|delolimogene mupadenorepvec|LOAd703 is an oncolytic adenovirus encoding TMZ-CD40L and 4-1BBL
15840075|NCT04123470|Biological|atezolizumab|Atezolizumab is an anti-PD-L1 antibody
15840076|NCT04123444|Drug|Iloprost|Continuously infusion for 72 hours. treatment dose 1 ng/kg/min
15840085|NCT04123392|Drug|Cyclophosphamide (CY)|Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
15840086|NCT04123379|Drug|Nivolumab|q4w, dosed twice before surgery and three times following recovery from surgery by injection
15840087|NCT04123379|Drug|BMS-813160|300mg oral twice a day for 28 days
15840088|NCT04123379|Drug|BMS-986253|2400mg once by injection
15840091|NCT04123340|Diagnostic Test|Additional intraprocedural pre-ablation CT-scan|In 20 patients, besides de regular post-RFA scan, a pre-RFA contrast enhanced dual phase CT-scan will be acquired to investigate the feasibility of quantitative ablation assessment.
15840092|NCT04123314|Drug|Psilocybin|Dosing at the first session will be 15 mg/70 kg. For the second session participants will either remain at the initial dose, or increase to 25 mg/70 kg at the discretion of the study team.
15840093|NCT04123301|Device|Active Theta Burst Stimulation (TBS)|Each session will be comprised of ACTIVE TBS: first, continuous inhibitory stimulation (cTBS) in the right dorsolateral prefrontal cortex followed by intermittent excitatory stimulation (iTBS) in the left dorsolateral prefrontal cortex.
15840094|NCT04123301|Device|Sham Theta Burst Stimulation (TBS)|The sham-TBS sessions will be performed using an identical coil that produces SHAM Stimulation: first, sham continuous inhibitory stimulation (cTBS) in the right dorsolateral prefrontal cortex followed by sham intermittent excitatory stimulation (iTBS) in the left dorsolateral prefrontal cortex.
15840095|NCT04123288|Drug|ACT-709478|1 film-coated minitablet contains 2 mg of ACT-709478
15840096|NCT04123288|Drug|ACT-709478|1 hard capsule contains 10 mg of ACT-709478.
15840097|NCT04123275|Other|No intervention wil be done. Patient characteristics and the standard care before and after withdrawal of life-sustaining treatment in all potential cDCD donors, will be studied. .|
15840098|NCT04123262|Drug|Tamoxifen 20 mg|Tamoxifen 20mg orally will be given once daily to participants with water
15840099|NCT04123249|Drug|Propofol|Group Propofol was given propofol 4mg/kg/h intravenous pumping to assist sedation
15840100|NCT04123249|Drug|Sevoflurane|Group Sevoflurane was given sevoflurane inhalation maintenance (concentration of 2% to 3% and mixed with 50% oxygen and air) to assist sedation；
15840101|NCT04123236|Other|Age 0-18|Patients under 18 years of age
15840102|NCT04123236|Other|Age 18-26|Patients over18 years of age
15840103|NCT04123236|Other|Girls|Girls
15840104|NCT04123236|Other|Boys|Boys
15840105|NCT04123223|Behavioral|Cognitive Remediation|Cognitive remediation (CR) is a behavioral treatment designed to address neurocognitive deficits through task practice and/or strategy acquisition.
15840106|NCT04123223|Behavioral|Computer Games|Sham placebo treatment
15840107|NCT04123210|Dietary Supplement|Vitamin A supplement|
15840108|NCT04123210|Dietary Supplement|Placebo|
15840109|NCT04123197|Other|Stress Challenge|The stress challenge will assess how different parts of the body react to stress. Participants will be given no specific details about the contents of the test before administration.
15840110|NCT04123171|Diagnostic Test|Neuroimaging studies|Complementary exams are not invasive and will be performed in enrolled individuals who sign a comprehensive informed consent form
15840111|NCT04123158|Diagnostic Test|Ultrasound|"Intervention: Diagnostic Test Ultrasound Ultrasound investigating the following characteristics: Maximum size of the lesion ≥ 8cm; Largest diameter rapid growth (Growth >30% per year); Irregular margins of the lesion; Presence of irregular cystic areas; Absence of acoustic shadow; Color Score 4; Cooked aspect; ]"
15840112|NCT04123158|Diagnostic Test|MRI|"Diagnostic Test: MRI; MRI investigating the following carachteristics:
~TARGET LESION Maximum diameter; Borders; Signal intensity on T2WI; Heterogeneity on T2WI; Cystic alteration(s); Cystic alteration(s) borders; Hemorrhage; T2 dark area(s); Flow voids; Signal intensity on DWI(b-1000); ADC value; ≥ 1,23 Signal intensity on contrasted images Intensity [relative to myometrium] (Hyper- / Hypo- / Iso- intense) Heterogeneity (Homogeneous / Heterogeneous) Unenhanced area(s) Presence (Present / Absent) Location (Central / None or non-central) 1 Tumour - myometrium contrast ratio on T2WI [SItumour - SImyometrium / SImyometrium]"
15840113|NCT04123145|Diagnostic Test|Iron status testing|Iron status testing
15840114|NCT04123132|Other|Kinesiophobia|The presence of kinesiofobia in patients with metabolic syndrome
15840115|NCT04123119|Biological|Rotavirus vaccine|An exploratory and observational cohort study following infants receiving two standard doses of live, attenuated, oral Rotarix™ administered at 6 & 10 weeks.
15840116|NCT04123106|Procedure|ESP block|ESP block bilaterally performed at the level of the surgical site prior to surgery.
15840117|NCT04123106|Procedure|Wound infiltration|Wound infiltration performed at the surgical site at the end of surgery.
15840118|NCT04123093|Device|Noxsano Bandage (Healthy Volunteers)|Healthy volunteers will wear the study device (Noxsano Bandage) for 3 consecutive days (up to 72 hours), followed by weekly visits for 4 weeks of observation for tolerance, side effects, and/or adverse reactions.
15840119|NCT04123093|Device|Noxsano Bandage (Wound Care)|Wound care subjects will have weekly study device (Noxsano Bandage) applications to a specific ulceration. For subjects that exhibit any reduction in wound surface area, this application will occur until the wound is healed, or for up to 3 months (whichever occurs first). For subjects that do not exhibit any reduction in wound size at 2 months, application will stop and standard treatment protocols will be pursued. At the conclusion of the treatment window (up to 3 months), subjects will be followed every 3 months for 12 consecutive months for observation of late side effects or adverse reactions (3 months of active treatment, 12 months of follow-up observation, 15 months total).
15840120|NCT04123080|Device|Endoscopic band ligation assisted polypectomy|A conventional upper endoscope loaded with a band ligator was inserted in the colon and was advanced to the site of the pedunculated polyp. After approaching the lateral side of the stalk and grasping the mid-portion of the stalk using a tripod grasper. Then, the rubber band was released from the cap to ligate the stalk. Thereafter, we performed polypectomy of the remaining stalk just above the ligation by extending the electrosurgical snare.
15840121|NCT04123067|Drug|Pioglitazone 45 mg|45mg Pioglitazone daily for three subsequent days, initiated within 12h of stroke symptom onset
15840122|NCT04123067|Drug|Placebo oral tablet|placebo daily for three subsequent days, initiated within 12h of stroke symptom onset
15840293|NCT04121520|Other|Questionnaire|"Comprehensive perioperative assessment
~Questionnaire administration"
15840123|NCT04123054|Device|Mobile App|Participants will use the mobile app to log their daily basal dose and calculate their meal doses by entering their sensor glucose value (and amount of meal carbohydrates if applicable) using the built-in bolus calculator.
15840124|NCT04123054|Device|Mobile App + Basal-Bolus Optimization Algorithm|Participants will use the mobile app to log their daily basal dose and calculate their meal doses by entering their sensor glucose value (and amount of meal carbohydrates if applicable) using the built-in bolus calculator. In addition, participants will receive weekly app notifications with personalized recommendations for insulin parameter adjustments made by the optimization algorithm.
15840125|NCT04123041|Other|JUUL ENDS, Combustible cigarette, comparator e-cigarette, Nicorette gum|JUUL ENDS and comparator e-cigarette will be used for 5 minutes ad libitum, one combustible cigarette will be used ad libitum, Nicorette gum will be used for 30 minutes ad libitum
15840126|NCT04123028|Other|observatory|observation for 1 year period
15840127|NCT04123002|Other|Miswak chewing sticks|Chewing stick are routinely used by this population
15840128|NCT04122989|Other|MS-SUPPORT|MS-SUPPORT is a shared decision making tool designed to be used by patients and providers.
15840129|NCT04122976|Drug|Darolutamide(Nubeqa, BAY1841788)|The decision on the dose and duration of treatment is solely at the discretion of the treating physician, based on the recommendations written in the local product information.
15840130|NCT04122963|Procedure|High power CLOSE-guided PVI ablation|CLOSE-guided PVI ablation with 45 Watt and stricter stability criteria (3 mm for 3 seconds)
15840131|NCT04122963|Procedure|Standard CLOSE-guided PVI ablation|Standard AF ablation according to the CLOSE-protocol
15840132|NCT04122950|Behavioral|Exergaming|The participants in the Exergaming group will use the PlayPulse exergame for 45 minutes a minimum of three times per week for 8 weeks. Between 8 and 12 weeks the exergaming group will be provided with free access to the exergame but without the two mandatory exergaming sessions
15840133|NCT04122937|Procedure|Cytoreductive surgery|Partial removal of peritoneal tissue involved by neoplastic invasion
15840134|NCT04122924|Other|Abdominal muscle training|The intervention starts 6-12 months postpartum and will last for three months with weekly follow-up through an exercise app. Before commencing the home-based program, women in the intervention group will have an individual session in how to perform the program with a physiotherapist. The intervention consists of a 10 min 5 days a week exercise program, including the following exercises; headlift, crunch and twisted crunch. General principles for strength training are followed: 3 sets of 8-12 contractions close to maximum. The participants will be provided with a smartphone app (Athlete Monitoring) to be reminded to exercise and to register adherence.
15840135|NCT04122911|Drug|Temozolomide|pharmacological
15840136|NCT04122898|Other|Pelvic Floor Muscle Training|The intervention will consist of a home-based PFM training program with weekly follow-up by phone by a physiotherapist. Before commencing PFM training, the gymnasts in the intervention group will have an individual session with a physiotherapist including thorough teaching on how to perform a correct PFM contraction (inward lift of the pelvic floor assessed with suprapubic 2D ultrasound) and instructions on how to perform the training program. The athletes will be offered at least one individual follow-up session with the same physiotherapist during the intervention period. The program will consist of 3 sets of 8-12 maximum contractions per day. An electronic app (Athlete monitoring) will be used to assess adherence to the program. The athletes will be asked to register their training sessions in a personal account. A reminder to adhere to the program will be sent by phone. The training period will be 3 months and the exercises will take approximately 10 minutes per day to perform.
15840137|NCT04122885|Combination Product|PIPAC with oxaliplatin|Oxaliplatin 92 mg/m2 BSA, applied as an aerosol for 30 min under normothermic conditions at 12-15 mmHg pressure
15840138|NCT04122885|Procedure|Cytoreductive surgery and Hyperthermic IntraPeritoneal Chemotherapy|If complete cytoreduction possible (CC-0). Application time 60 min, T 41-43 °C
15840139|NCT04122859|Device|Zip Skin Closure Device|The device is a CE-marked, single use, sterile medical device that is designed to provide closure speed superior to sutures, while resulting in a suture-like cosmetic outcome. It adheres to the skin adjacent to an incision or laceration by use of pressure-sensitive skin adhesives.
15840140|NCT04122846|Behavioral|Emotional Awareness and Expression Therapy|"Very much based on Unlearn your pain by Howard Schubiner."
15840141|NCT04122833|Other|Next generation sequencing|observational study
15840142|NCT04122820|Diagnostic Test|Diagnostic of specific learning disabilities or of Developmental Coordination Disorder|Speech therapy assessment, or occupational therapy. In case of pathological disorder, search for a sensory disorder, and therapeutic management. If the pathological disorder persists for more than six months, elimination of a secondary etiology.
15840143|NCT04122807|Procedure|Cardiac catheter ablation|Cryoablation
15840144|NCT04122781|Device|Novel K-wire fixation devices|The patients received surgery using novel K-wire fixation devices
15840145|NCT04122768|Behavioral|Multi-component physical activity tele coaching intervention|"A.Education about the importance of PA. During a one-to-one interview with the coach motivation, self-efficacy, barriers, favorite activities and strategies to become more active are discussed.
~B. Step counter providing direct feedback.
~C.A smartphone with a project-tailored application. The application provides automated coaching by displaying an activity goal (number of steps) and feedback on a daily basis. The feedback comes with a graphical presentation. Patients' targets are automatically revised weekly. The aim is to progressively increase the PA during the 12 weeks period and maintain afterwards.
~D.Telephone contacts triggered in the case of non-compliance with wearing the step counter, failure to transmit data or failure to progress. Coaches are alerted by a note at the coaches' backend to take contact with the patient if needed."
15840146|NCT04122768|Behavioral|Light coaching intervention|"A. Education about the importance of PA. During a one-to-one interview with the investigator, patients will receive a personal goal (expressed in steps/day), based on their individual exercise capacity.
~B.A step counter providing direct feedback.
~C.A smartphone with a project-tailored application. The application receives the step data of the patient and asks on a weekly basis about the patient's change in medication. The application does provide a graph showing the steps the patient took and presents a general activity plan including their personal goal (which stays the same throughout the entire intervention period)."
15840147|NCT04122755|Drug|ALA-1000|Blood sample for PK analysis are collected before and post single injection of ALA-1000 (Day1) according to the schedule of procedures. Subjects remain in the residential phase through Day21 for safety assessment.
15840148|NCT04122755|Drug|buprenorphine sublingual film|ALA-1000 injection after 7 days of buprenorphine sublingual film dosing. Blood sample for PK analysis are collected before and post sublingual buprenorphine dosing on Day-1
15840149|NCT04122742|Procedure|skin biopsy for the primary fibroblast culture and a 15 ml blood sample (3 unnamed samples of 5ml) in each of the 4 SRT patients included.|Performed with a 3 mm diameter punch under local anesthesia. The procedure can be done in a consultation office respecting a strict asepsis.
15840150|NCT04122742|Other|Generation of Induced Pluripotent Stem Cells (iPSC) from fibroblasts obtained by skin biopsy|induced Pluripotent Stem Cells (iPSC) production of patients with CREBBP mutation and differentiation into cortical neurons and pyramidal neurons
15840151|NCT04122742|Other|Histone acetylation profiles of cells of SRT patients with CREBBP mutations|Study of acetylome by liquid chromatography coupled with tandem mass spectrometry (LC-MS / MS) Validation of specific acetylation targets by ChIP-Sequencing
15840152|NCT04122742|Other|Functional involvement of identified epigenetic alterations|Transcriptome analysis with RNA-Seq Generation of isogenic iPSC clones by correction of CREBBP mutations in SRT patients by CrispR-Cas9.
15840153|NCT04122742|Biological|Culture of lymphoblastoid line from blood sample|Achievement of a ficoll Culture of lymphoblasts and conservation Establishment of lymphoblastoid line and conservation
15840154|NCT04122716|Drug|Liraglutide|"Daily injections (3mg) with weight consultations starting at dose of 0.6 mg injections with 0.6 mg increments weekly until 3.0 mg is achieved. For subjects who do not tolerate the fast weekly up-titration of 0.6 mg study drug until the 3mg, the titration procedure can be prolonged with up to three weeks for each up-titration.
~Subjects who do not tolerate the 3mg dose may in special circumstances stay at 2.4 mg, however the overall aim is to reach 3 mg for all study subjects.
~The dosage and up-titration follow the recommendations from the summary of product characteristics."
15840155|NCT04122716|Behavioral|Exercise|"150 min of moderate intensity, 75 min of vigorous intensity, or an equivalent combination of moderate and vigorous intensity exercise per week in accordance with WHO recommendations.
~Exercise prescription will be performed under strict control of the scientific personnel.
~There will be aerobic exercise and will include 4 sessions per week after the ramp-in period.
~2 sessions per week will be performed under supervision of the staff and 2 sessions will be performed individually but monitored by the staff.
~Supervised sessions include structured exercise with a duration of 45 min. Of this 30 min will comprise of interval-based spinning session and 15 min circuit training program focusing on large muscle groups.
~Individual exercise includes aerobic exercise and general physical activity (e.g brisk walking and cycling to work).
~Participants will use heart rate monitors during sessions."
15840156|NCT04122703|Device|percutaneous tibial nerve stimulation (PTNS)|The PTNS treatments will be given in 30 min sessions. The PTNS treatment consists of inserting a 34-gauge needle electrode approximately 5 cm cephalad to the medial malleolus and, as well as placing a PTNS surface electrode on the ipsilateral calcaneus. To keep the electrode placement consistent with the sham treatment, 2 inactive transcutaneous electrical nerve stimulation (TENS) surface electrodes are also added, 1 placed under the little toe and 1 on the top of the foot. The PTNS lead set is connected to the Urgent PC stimulator, and a current level of 0.5 to 10 mA at 20 Hz is delivered until the flexion of the big toe is observed or the patient reports a radiating sensation at the sole of the foot.
15840157|NCT04122703|Device|Sham procedure|The sham treatment, involves simulating the sensation of the PTNS needle insertion at the same location using a Steritberger placebo needle. This is a blunt tip needle which simulates the sensation of a needle prick when touched to the skin, however, the blunt tip retracts into the handle when pressed into the skin. This creates the illusion of the needle entering the skin, without breaking the skin's surface. An inactive PTNS surface electrode is also placed on the ipsilateral calcaneus. The two TENS surface electrodes, placed in the same location as the PTNS treatment, are active and deliver stimulation mimicking the sensory effects of the PTNS. However, since no electrode needles were inserted near the tibial nerve, there will be no tibial nerve stimulation
15840158|NCT04122690|Behavioral|PDAE|Participants with PD will dance the follower role only and will dance with new partners (individuals without PD) every 15-20 minutes, a widely practiced method considered by the dance teaching community to enhance learning. Participants will engage in partnering exercises on how to interpret motor goals through touch, exercises to develop understanding of temporal relationship of movement to music, novel step introduction, connecting previously learned and novel step elements. Frequent repetition and musical stereotypes may foster implicit learning or muscle memory (i.e., motor learning, or procedural memory that involves consolidating a specific motor task into memory through repetition). Participants will not be required to memorize specific step patterns but will learn new steps in each class
15840159|NCT04122690|Behavioral|WAE|The participants will receive equal contact and monitoring from study staff. WAE participants will report to the same facility and interact with the same interventionist and assistants. The participants will participate in sessions focused on at least 60 minutes of walking with breaks ad libitum, and 1/2 hour balance and stretching. The investigators have a designated, safe and non-cluttered area for walking. WAE will also take place in groups, with research volunteers and assistants to ensure that PDAE and WAE participants both receive a socially engaging intervention
15840160|NCT04122677|Device|Anterior Cruciate Ligament Reconstruction|Reconstruction of the Anterior Cruciate Ligament using an interference screw.
15840161|NCT04122664|Device|RayOne® Hydrophobic lens 800C|Patients will receive a monofocal, aspheric, hydrophobic acrylic intraocular lens: the RayOne® Hydrophobic lens 800C
15840162|NCT04122664|Device|RayOne® Hydrophilic lens 600C|Patients will receive a monofocal aspheric, hydrophilic acrylic intraocular lens: the RayOne® Hydrophilic lens 600C.
15840163|NCT04122651|Procedure|'Off the shelf' toric lens|'Off the shelf' toric lens (either 2.00D or 4.00D) and combined limbal relaxing incisions and/or off-axis inttaocular lens rotation
15840164|NCT04122651|Procedure|Tailored Toric lens|Fully targeted toric intraocular lens correction for corneal astigmatism
15840167|NCT04122599|Drug|Melatonin|Melatonin for prevent post stroke delirium
15840168|NCT04122586|Drug|Tongxieyaofang(granule)|Take this granule twice a day,one bag for each time,one hour after a meal,for 4 weeks
15840169|NCT04122573|Diagnostic Test|Coronary angiography|Acute chest pain patients, suspected acute coronary syndrome, are diagnosed by coronary angiography.
15840170|NCT04122573|Diagnostic Test|CT angiography of aorta|Acute chest pain patients, suspected acute aortic dissection, are diagnosed by gold standard of CTA.
15840171|NCT04122573|Diagnostic Test|CT angiography of pulmonary arteries.|Acute chest pain patients, suspected acute pulmonary embolism, are diagnosed by gold standard of CTA.
15840172|NCT04122573|Diagnostic Test|Electrocardiogram|All patients with acute chest pain will subject to ECG examination within 10 minutes of admission, which can quickly screen ST-segment elevation myocardial infarction.
15840173|NCT04122573|Diagnostic Test|Cardiac Troponin|Dynamic changes of cardiac troponin I and/or T will be used in the diagnosis of acute myocardial infarction
15840174|NCT04122560|Drug|Fluconazole 200mg tab|PO dose of 400mg
15840175|NCT04122560|Drug|Fluconazole 2 MG/ML|IV dose of 400mg
15840176|NCT04122547|Drug|Roflumilast|Active drug
15840177|NCT04122547|Drug|Placebo|Placebo one tablet oral od
15840178|NCT04122534|Behavioral|Somatic Mindfulness Training|Educational and experiential training to reduce occupational-based secondary trauma.
15840179|NCT04122521|Diagnostic Test|MRI|MRI
15840180|NCT04122495|Dietary Supplement|Probiotic|Oral administration of B. lactis M8 at 10 log CFU/day for 4-weeks
15840181|NCT04122495|Dietary Supplement|Placebo|Oral administration of maltodextrin daily for 4-weeks
15840182|NCT04122482|Behavioral|Psychoeducation Course|The investigators are assessing the efficacy of the accommodations course. Specifically, the investigators will evaluate the impact on requesting and receiving accommodations for anxiety and/or depression, employee knowledge of accommodations, and employee self-stigmatizing attitudes. The investigators will also assess if the course helps improve comfort level of disclosing a mental health diagnosis and rates of disclosure in the workplace.
15840183|NCT04122469|Radiation|Stereotactic Body Radiotherapy|A previous study found that in four of the five metastatic GI patients, SBRT increased the duration of effective systemic therapy with no significant additional toxicities. There have been small number of case reports in lung and renal cancers, which suggest the potential for improvement in progression free survival. The purpose of this study is to evaluate the safety, and efficacy of SBRT in this patient population
15840184|NCT04122456|Radiation|Ultraviolet B Radiation|One skin punch biopsy will be taken to the laboratory for exposure to ultraviolet B radiation. After 1-hour incubation, the biopsies will be bisected in half.
15840185|NCT04122456|Other|No Ultraviolet B Radiation|One skin punch biopsy will be taken to the laboratory and will be kept as a non-irradiated control.
15840186|NCT04122443|Drug|Acetaminophen|Acetaminophen 650mg
15840187|NCT04122443|Drug|Oxycodone|Oxycodone 10mg
15840188|NCT04122430|Other|Review of Health Information|
15840189|NCT04122417|Other|The Effect Of Therapeutic Touch Training Given To Mothers With Preterm Babies On Attachment Level And The Responses The Baby|The study was carried out as randomized experiment to determine the effect of Yakson or Gentle Human Touch method practiced by mothers to preterm newborns on the maternal attachment level and the baby's responses.
15840190|NCT04122404|Diagnostic Test|LF-LAM|Open label multi-center stepped wedge cluster-randomized controlled trial with implementation of LF-LAM. All clusters (i.e. HIV/ART clinic attached wards) start with standard of care and are then randomized to switch to the intervention phase at predefined time points.
15840191|NCT04122391|Other|sound level volume|Noise level during cardiac arrest
15840192|NCT04122378|Other|acupuncture|The acupuncture will be provided by the licensed acupuncturist using standard methods.
15840193|NCT04122365|Other|Chest Wall Mobilization Program|Soft tissue therapy and joints mobilization
15840194|NCT04122365|Other|Control|Routine limbs exercises and education
15840195|NCT04122352|Other|Ischemic compression|Ischemic compression was performed 3 times ; after the initial evaluation, after the first week evaulation and after the second week evaulations.
15840196|NCT04122352|Other|Exercises (Rocabodo's 6x6 exercises and posture exercises)|Rocabodo's 6x6 exercises exercise was shown to be administered for 4 weeks. After the first week evaluation, posture exercises are added to the exercise programs of the patients.
15840197|NCT04122339|Drug|MAX-10181|"Part 1: Dose escalation, MAX-10181 once or twice daily with dose modifications based on tolerability criteria.
~Part 2: Dose expansion, Recommended doses from Part 1."
15840198|NCT04122326|Behavioral|Workstation Modification|Participants are asked to work in a sequence of workstation setups for ten minutes each. The sequence include 1. sitting with workstation adjusted by the participant, 2. sitting with workstation adjusted to promote proper posture, 3. sitting with workstation adjusted to promote unnatural posture, 4. standing with workstation adjusted by the participant, 5. standing with workstation adjusted to promote proper posture, and 6. standing with workstation adjusted to promote unnatural posture. After the sequence of setups, the participant allowed to adjust the workstation in either sitting/standing to work in 60 minutes in their own desired position.
15840199|NCT04122313|Other|Evaluation of Dupuytren's Disease Treatment|There are no study interventions. The study interaction will be asking the patients to complete an additional outcome questionnaire and allow a medical record review.
15840200|NCT04122300|Drug|Euphrasia Officinalis Preparation|At inclusion, before the start of the therapy, a bacterial/viral and chlamydial conjunctival swab is conducted. Afterwards, both eyes of neonates are washed four times a day (i.e., every six hours) with NaCl 0.9%. Subsequently, a drop of Euphrasia is placed into the lower conjunctival sac of each eye, and followed by a lacrimal sac digital massage. If no ocular discharge is apparent for over 24 hours, the therapy is stopped. In case of worsening of symptoms or a positive swab without any improvement of symptoms an antibiotic therapy is initiated: tobramycin (Tobrex 0.3% eye drops, Novartis Pharma Switzerland). An additional swab is performed at 96 hours (i.e. at the end of the study).
15840201|NCT04122300|Drug|Placebo|At inclusion, before the start of the therapy, a bacterial/viral and chlamydial conjunctival swab is conducted. Afterwards, both eyes of neonates are washed four times a day (i.e., every six hours) with NaCl 0.9%. Subsequently, a drop of placebo is placed into the lower conjunctival sac of each eye, and followed by a lacrimal sac digital massage. If no ocular discharge is apparent for over 24 hours, the therapy is stopped. In case of worsening of symptoms or a positive swab without any improvement of symptoms an antibiotic therapy is initiated: tobramycin (Tobrex 0.3% eye drops, Novartis Pharma Switzerland). An additional swab is performed at 96 hours (i.e. at the end of the study).
15840204|NCT04122274|Behavioral|NCAA education sheet|A fact sheet that includes information about basic signs and symptoms of a concussion as well as steps to take if an individual sustains a concussion and reinforces the need to report the injury.
15840205|NCT04122274|Behavioral|Sham Intervention|An approximately 7-minute video that includes information about basic sports nutrition facts.
15840206|NCT04122274|Behavioral|Decision-based interactive concussive education platform|A platform grounded in theoretical frameworks including the socioecological model and theory of planned behavior. It includes a short video to provide an overview of key lessons, a short quiz, and additional resource links that conclude the module.
15840209|NCT04122248|Other|standard radiographic imaging|standard radiographic imaging
15840210|NCT04122235|Other|LETSGO follow-up|Nurse-led follow-up in 50% of the consultations Access to the LETSGO-app
15840211|NCT04122222|Biological|Influenza vaccine|A single standard dose of inactivated trivalent influenza vaccine: Influvac® vaccines (Abbott, the Netherlands), intramuscularly.
15840212|NCT04122209|Other|HIIE-First|Multiple exercise bout during the same day; HIIE first followed by continuous exercise
15840213|NCT04122209|Other|Continuous-First|Multiple exercise bout during the same day; Continuous exercise first followed by HIIE
15840216|NCT04122183|Other|iManage (my hearing loss)|An internet-based decision coaching guide to help an individual decide if they wish to visit an audiologist.
15840217|NCT04122170|Drug|Ticagrelor Oral Tablet - Pre-Treatment|Ticagrelor 90 mg oral tablet; administered as 180 mg (2 × 90 mg tablet) loading dose plus 90 mg every 12 hours for 4 additional doses.
15840218|NCT04122170|Drug|Aspirin (ASA) Oral Tablet - Pre-Treatment|Aspirin 81 mg oral tablet; administered daily between Day -7 to the morning before receiving study medication on Day 1, for a total of 8 tablets only.
15840219|NCT04122170|Drug|PB2452 Infusion|"PB2452 18 g Intravenous Infusion over a 16 hour duration
~In subjects with potential drug interaction from concomitant use of moderate or strong CYP3A inhibitors with ticagrelor, the active treatment period may be 24 hours and 10 min if receiving the 36 g infusion."
15840220|NCT04122170|Drug|Placebo (0.9% Sodium chloride) infusion|0.9% Sodium chloride Intravenous Infusion over a 16 hour duration
15840221|NCT04122144|Behavioral|ENHANCED -SPS intervention|a) Enhanced VL counseling: Explanation of VL & Importance of VL suppression,assessment of adherence, counseling based on VL result and schedule for next VL testing and the role of VL and the MTCT risk; b).Standardized peer mother support: includes training of peer mothers on mandatory enhanced VL counseling during the routine peer counseling and education, follow up of mothers and continued adherence counseling and disclosure support and bi-weekly phone calls to mothers to provide VL counseling and follow up
15840222|NCT04122131|Diagnostic Test|Immunohistochemistry|Immunohistochemical analysis of biomarker in post-surgical sample
15840223|NCT04122118|Other|Medical Chart Review|Review of medical chart
15840224|NCT04122118|Other|Educational Intervention|Receive pharmacist-led education
15840225|NCT04122118|Other|Survey Administration|Ancillary studies
15840226|NCT04122105|Drug|Sildenafil|The intervention group will receive standard care in all capacities with the exception of sildenafil administration. The first dose (50mg) will be given 1-hour prior to the surgery. Patients will be given Sildenafil twice daily up to 3 days post-transplant.
15840227|NCT04122092|Diagnostic Test|The level of plasma cfDNA CINs|The extracted cfDNA from PB will be analyzed by UCAD to determine the level of CINs
15840228|NCT04122066|Drug|sofosbuvir \daclatsvir|study the effect of the new oral antihepatitis C drugs on the respiratory system
15840229|NCT04122053|Behavioral|Intervention group with genotype information|Results of genotyping will be translated into personalised dietary recommendations. Subjects will be informed about their genotypes from the beginning of the study. The importance of personalised recommendations will be explained.
15840230|NCT04122053|Behavioral|Control group without genotype information|Subjects will receive personalised dietary recommendations, but at the beginning they will not be informed about their genotypes and the meaning of personalisation. Information about their genotype will be given to the participants at the and of study.
15840231|NCT04122040|Drug|Roxithromycin 300 MG|Roxithromycin 300 mg oral per day
15840232|NCT04122040|Drug|Placebo|Placebo one table oral once dialy
15840233|NCT04122027|Other|Cerebral oximeter|Near infra-red spectroscopy, NIRS
15840234|NCT04122014|Other|Progressive balance training|Progressive balance training program
15840235|NCT04122014|Other|Normal daily activities|Usual daily activities
15840236|NCT04122001|Device|Active HD-tDCS|Stimulation will be delivered by a battery-driven constant current stimulator. The electrical current will be administered to a pre-specified region of the brain (angular gyrus). The stimulation will be delivered at an intensity of 2 milliamperes (mA) (estimated current density 0.04 mA/cm2; estimated total charge 0.048 Coulombs/cm2) in a ramp-like fashion for a maximum of 20 minutes.
15840237|NCT04122001|Device|Sham|Current will be administered in a ramp-like fashion but after the ramping the intensity will drop to 0 mA. Current under the Sham condition will last for a maximum of 30 seconds.
15840238|NCT04122001|Other|Word List Learning Intervention (WordLLI)|Participants will receive a word list learning intervention (WordLLI) of semantically related and unrelated word lists. Word lists are presented across 10 trials, with an additional trial after a 10-minute delay to assess delayed recall. Immediately following verbal presentation of word lists during each trial, participants will be instructed to recall as many of the words from the list as possible. Participants may use the written modality as a strategy during recall. Word lists include 12 words matched based on psycholinguistics attributes (e.g., imageability, frequency). This task is designed to help participants improve memory via enhancing list learning capabilities.
15840294|NCT04121507|Drug|High dose chemotherapy before allogeneic stem cell transplantation (alloSCT)|High-dose therapy (HDT) prior to alloSCT will consist of FTC
15840239|NCT04121988|Diagnostic Test|MRI|"1 mm slice thickness with deep learning based reconstruction algorithm applied to the following sequences:
~Coronal T2 weighted imaging
~Dynamic contrast enhanced T1 weighted imaging
~Coronal contrast enhanced T1 weighted imaging"
15840240|NCT04121975|Radiation|Radiotherapy|Radiotherapy was administered in 1.8-2.0 Gy fractions 5 times weekly to a total dose of 45-50 Gy.
15840241|NCT04121975|Drug|Endostar|30 mg/d was administered on days 1-5 every two weeks for 4 cycles.
15840242|NCT04121975|Drug|Cisplatin|30-40 mg/m2 was administered day 1, 8, 15, 22 and 29.
15840243|NCT04121962|Behavioral|Peer Mentor|Participants will be trained to be Peer Mentors and promote home-based testing to their social network
15840244|NCT04121962|Behavioral|Website only|Participants will be given instructions on how to use the project website to request kits to test for HIV at home and collect specimens for lab testing.
15840245|NCT04121949|Device|CADScor®System|The CADScor®System is a low cost, low resource-demanding, non-invasive, radiation-free device using highly advanced analysis of sounds originating from blood flow turbulence in the coronary circulation and myocardial motion. Heart sound recordings are obtained transcutaneously during a 3 minutes recording period with a microphone mounted at the IC4. A CAD-score on a scale from 0 to 99 is estimated immediately after the recording with a fully automated algorithm. The algorithm measures eight acoustic properties and the resulting acoustic score is combined with the clinical risk factors gender, age, and hypertension. The entire procedure lasts approximately 10 minutes.
15840246|NCT04121936|Other|There will be no intervention|There will be no intervention
15840247|NCT04121923|Device|Belun Ring Pulse Oximeter|Belun Ring Pulse Oximeter allows measurement and analysis of oximetry, pulse rate, photo-plethysmography (PPG), and accelerometer signals from the proximal phalanx of index finger. Total sleep time (Ring-TST) and respiratory event index (Ring-REI) are estimated
15840248|NCT04121910|Drug|Savolitinib|On Study Day 1 and Study Day 18, savolitinib will be administered as single dose after a high-fat, high-calorie breakfast
15840249|NCT04121910|Drug|Itraconazole|Twice daily on first day of dosing (Study Day 15) followed by once daily for 4 days (Study Day 16 - Study Day 19) administered 1 hour before any breakfast (and 1 hour before dinner on Study Day 15)
15840250|NCT04121897|Other|Therapist Education and Massage for Parents of Extremely Preterm Infants|"TEMPO includes these components:
~Early Parent Education Session
~Weekly Parent Education Sessions
~Infant Massage Parent Education Sessions
~Discharge Parent Education Session
~Parent Education Post-Discharge
~Bi-weekly emails (or texts)
~2 Month Follow-up Massage Review Session"
15840251|NCT04121884|Behavioral|Accelerated Resolution Therapy|"The ART protocol first uses the technique of imaginal exposure to elicit physiological reactions associated with patient recall from beginning to end (verbally or non-verbally) of a traumatic/distressing experience. As physiological reactions emerge, the participant is directed to focus their attention on the specific body-centric reactions while laterally performing smooth pursuit eye movements which are achieved by tracking the clinician's hand which oscillates from left-to-right at a short distance from the participant's eyes. Then the participant is directed to imagine a positive way in which they prefer to recall their experience(s), including emphasis on replacing negative images in the brain with positive images. This technique is based on the process of memory reconsolidation, which allows for adding of positive material to the recall of negative, highly emotional past experiences."
15840252|NCT04121871|Other|No intervention|Not required
15840253|NCT04121858|Other|Brain Safe App|The Brain Safe app includes the medication list, a personalized risk calculator, multimedia educational content, and a conversation starter/doctor's report.
15840254|NCT04121858|Other|Attention Control App|The attention control app, called Med Safe, includes only the medication list feature.
15840255|NCT04121845|Device|Coronary Sinus Reducer device|Coronary sinus reducer device (Neovasc, Richomnd, Canada) implantation in the coronary sinus. The procedure is performed in the cardiac catheterization laboratory through right internal jugular vein.
15840256|NCT04121845|Other|Sham procedure|Puncture of the right internal jugular vein and simulation of the CSR implantation procedure.
15840257|NCT04121832|Device|Biofeedback training treatment in Fibromyalgia, a pilot study|The selected sample will undergo 10 total Biofeedback Training sessions, once a week. Each session will last 45 minutes. The total duration of the treatment will be 10 weeks
15840258|NCT04121832|Other|Control (treatment as usual)|The sample will be treated only with standard therapies without the use of biofeedback training for 10 weeks
15840259|NCT04121819|Drug|Cytarabine|cytarabine 100mg/m2 d1-5 subcutaneous
15840260|NCT04121806|Other|UC intervention diet|The treatment diet has been designed based on the literature with the goal of influencing the biodiversity and density of the microbiome. All food through the duration of the 8 week dietary intervention period of the study will be provided to the treatment arm study participants.
15840261|NCT04121793|Device|Kinesia 360 and Smartphone sensors|Data will be recorded from the Kinesia 360 system and smartphone sensors using the AWARE Framework.
15840262|NCT04121780|Biological|Growth Hormone|"Daily self-injections by subjects:
~1-year double-blind phase; 6-month open-label extension for those who received placebo during the double-blind phase"
15840263|NCT04121780|Other|Placebo|"Daily self-injections by subjects:
~1-year double-blind phase"
15840264|NCT04121767|Drug|Edoxaban|oral edoxaban 60mg once daily for 3 months
15840265|NCT04121767|Drug|Warfarin|oral warfarin once daily for 3 months according to prothrombin time
15840266|NCT04121741|Other|Singing with Music Therapist|Music therapy sessions will begin with vocal and breathing warm-up exercises for about 10 minutes. The Music Therapist will play the songs (chosen from a list by the subject) to sing along to and will alter the characteristics of the music (volume, tempo, level of support) to ensure a successful experience for subjects and motivate them to put forth more effort into singing the song. The music therapist will continue to coach throughout the 30-minute session, reminding subjects of strategies practiced and how to implement those strategies while singing. Music therapy sessions will be led by Erica Flores, MT-BC, WMTR, Owner of Healing Harmonies Music Therapy, or a member of her team. Erica and her team of MTs were trained in Neurological Music Therapy.
15840267|NCT04121741|Other|Singing with Guided Video|The videos will include a vocal warm-up (10 minutes long). The subject will then have the option to select and sing two songs (10 minutes each), with offerings in four music genres including Folk, Pop, Country, and a Hymn. Each piece will vary in tempo, melodic contour, and rhythm. The total duration of singing via this format will be 30 minutes.
15840268|NCT04121741|Other|Control Arm|30 minute rest period, no singing will take place during this arm. During this rest period a member of the study team will assist the subject in a hearing test using headphones, a tablet, and a trumpet app. This is done to asses the current hearing level of the subject.
15840269|NCT04121728|Drug|Ginkgo biloba extract|Symfona® commercial standardized Ginkgo biloba extracts are used in this study, at a rate of 2 capsules of 120 mg per day for 170 days.
15840270|NCT04121728|Drug|Placebo|The placebo is presented in the form of capsules of identical mass, color and shape to those of the study product. It is composed of lactose, the excipients present in Symfona® 120 mg and colorants. The dosage is identical to that of the investigational product.
15840271|NCT04121715|Device|Fastigial Nucleus Stimulation|Select mode 3, frequency 136, intensity below 90, ratio 1.0-2.0, based on the patient's no discomfort. The main pole is attached to the bilateral mastoid, and the auxiliary pole is attached to the bilateral internal cave. Non-invasive introduction of bio-electricity into the cerebellar nucleus for stimulation
15840272|NCT04121715|Drug|Standard treatment|"Refer to the Guidelines for Rational Use of Coronary Heart Diseases.rational selection of antiplatelet drugs, statins, etc. according to the patient's condition"
15840273|NCT04121702|Procedure|Cardiac Rehabilitation|Implementation of a physical exercise program (PEP) with tele-monitoring
15840274|NCT04121689|Dietary Supplement|Milk Protein Concentrate|The macronutrient composition and energy of the milk protein beverage provided to participants is 38 g protein (3.46 g leucine), 4.17 g carbohydrate, and 1.4 g fat. The milk protein met all chemical and bacteriologic specifications for human consumption. The L-[1-13C]phenylalanine and L-[1-13C]leucine enrichments in the milk protein concentrate averaged 38.3 and 10.8 mole percent excess (MPE), respectively.
15840275|NCT04121676|Drug|AGEN2373|An Anti-CD137 Monoclonal Antibody
15840276|NCT04121676|Drug|AGEN2373|An Anti-CD137 Monoclonal Antibody
15840277|NCT04121676|Drug|Balstilimab (AGEN2034)|Balstilimab (AGEN2034) A fully human monoclonal Anti-PD-1 Antibody. (AGEN2373) An Anti-CD137 Monoclonal Antibody
15840278|NCT04121663|Device|Total arthroscopic rotator cuff repair|The equivalence of the two devices was compared by using control and experimental instruments during the operation
15840279|NCT04121650|Behavioral|Collaborative Problem Solving|CPS is an approach for understanding and reducing challenging behavior in youth. Under CPS, caregivers are taught to understand and identify the specific neurocognitive skill deficits that underlie their child's challenging behavior. Then the caregivers are taught to interact with the child in a way that solves chronic behavior problems while building the lagging neurocognitive skills to avoid future problems.
15840280|NCT04121637|Other|Aerobic Exercise|"Each exercise session;
~5 min warm-up = 30% of VO2 max
~20 min exercise = 50-60% of VO2 max
~5 minutes cooling in the form. The goal of aerobic exercise is to increase physical capacity, which is represented by maximum oxygen uptake (VO2max) and mechanical power generated during exercise. Training programs should be conducted at least 2 to 3 times per week (60-80% maximum work rate or 60% VO2max) for 30 to 60 minutes at moderate concentrations. These programs are effective in increasing aerobic capacity and power output in MS."
15840281|NCT04121637|Other|Frenkel coordination exercises|Patients will be given Frenkel Coordination exercises (4 different exercises 4-5 repetitions depending on the individual's functional and motor status) 3 times a week for 6 weeks. 1 minute break between each exercise set
15840282|NCT04121624|Device|novel mobile phone application for blood pressure monitoring.|Comparative blood pressure measurement with the smartphone application and the non-invasive reference method (upper arm cuff).
15840283|NCT04121611|Drug|Unfractionated heparin|"Intravenous unfractionated heparin (UFH) infusion within 6 hours of EVT with target activated partial thromboplastin time (aPTT) 64-86
~Anticoagulation to continue for minimum of 48 hours (can be maintained on UFH aPTT 64-86 or transitioned to low-molecular weight heparin (LMWH) Enoxaparin 1mg/kg)"
15840284|NCT04121611|Drug|Acetylsalicylic Acid (ASA)|"Acetylsalicylic Acid (ASA) 325mg PO/PR/NG loading dose < 2 hours of EVT completion
~ASA 81mg PO OD maintenance dose"
15840285|NCT04121598|Other|Observational|Observational data will be obtained through self-report measures, parental report measures, cognitive assessments, and a semi-structured interview.
15840286|NCT04121585|Device|Total Hip Arthroplasty|Total Hip Arthroplasty using the SL-PLUS™ hydroxylapatite coated cement free hip stem
15840287|NCT04121572|Device|Nasal cannula capnography|Capnography: a continuous wave form of the CO2 level with the digital reading of CO2 level at end of expiration
15840288|NCT04121559|Behavioral|A&T Interventions|"Classroom sessions/lessons related to nutrition, dietary diversity, healthy food choices and hand washing.
~School assemblies and discussions facilitated by Health Extension Workers (HEWs) related to nutrition, dietary diversity, healthy food choices and hand washing.
~Kids club activities addressing nutrition, dietary diversity, healthy food choices and handwashing.
~Parent-teacher association meetings, HEW-led community discussions, and other community gatherings to inform and encourage parents about adolescent nutrition, dietary diversity, importance of breakfast before school and healthy snacks, and handwashing.
~Workshop on the adolescent nutrition interventions above for school principals, science teachers, HEWs, supervisors, and woreda officers.
~Monthly/biweekly supportive supervision on adolescent nutrition activities for schools and HEWs by school supervisors or woreda health/education office."
15840289|NCT04121546|Behavioral|Telecare Intervention|Patients will meet with a care coordinator to decide upon an opioid tapering schedule and fill out baseline measures. A 6 week positive psychology intervention will also be introduced in which patients will practice different techniques each week over 6 weeks, and will then practice incorporating a single technique into daily practice for the remaining 6 weeks. During the first 6 weeks, patients will have weekly check in meetings with a care manager to report on any withdrawal symptoms. These meetings will space to ever other week during the remaining 6 weeks. Possible treatment adjustments will be discussed between the care coordinator and primary investigator at weekly meetings. At the completion of the 12 week study, patients will complete 12 week measures.
15840290|NCT04121533|Dietary Supplement|Placebo|Placebo supplement for vitamin D (cholecalciferol), glucosamine sulfate, and omega-3 fatty acids. Supplement was taken orally every day for 84-days.
15840291|NCT04121533|Dietary Supplement|Vitamin D (cholecalciferol)|Vitamin D (cholecalciferol). Supplement was taken orally every day for 84-days.
15840292|NCT04121533|Dietary Supplement|Glucosamine sulfate and omega-3 fatty acids|Glucosamine sulfate and omega-3 fatty acids supplement was taken orally every day for 84-days.
15840295|NCT04121507|Procedure|Bone marrow histology|Bone marrow histology at staging and restaging is only mandatory if the bone marrow was initially involved
15840296|NCT04121507|Diagnostic Test|clinical and laboratory parameters|During staging and restaging examinations, all clinical and laboratory parameters relevant for therapy.
15840297|NCT04121507|Diagnostic Test|PET-CT or CT|Metabolic CR in a PET-CT scan after the last cycle of therapy prior to planned SCT. Consists preferably of a PET-CT or a CT scan according to local practice and other appropriate diagnostic procedures with respect to the sites of primary involvement.
15840298|NCT04121494|Biological|ChadOx1 85A - aerosol|Aerosol administration through the Omron MicroAIR NE-U22 nebuliser
15840299|NCT04121494|Biological|ChadOx1 85A - IM|Intramuscular administration
15840300|NCT04121481|Dietary Supplement|Clinical Investigation on Enhanced Sports Nutrition and Performance Activities by Prodovite VMP35 Supplement|Assess the Sports Nutrition efficacy of Prodovite VMP35 against the Placebo sample
15840301|NCT04121481|Dietary Supplement|Broad Spectrum Safety|Benefits in Sports Nutrition
15840302|NCT04121468|Drug|Metformin|Each tablet contains 500mg of metformin hydrochloride
15840303|NCT04121468|Other|Placebo|Each tablet contains no active drug ingredient
15840304|NCT04121455|Drug|Olaptesed pegol|Olaptesed pegol continuous administration for 26 weeks
15840305|NCT04121455|Radiation|Radiotherapy|Radiotherapy in weeks 1-6; cumulative dose of 60 Gy in 2 Gy fractions
15840306|NCT04121442|Biological|Isunakinra|Isunakinra is a recombinant protein that binds to the IL1R1 and potently blocks IL-1 alpha and IL-1 beta signaling
15840307|NCT04121442|Biological|PD-(L)1 Inhibitor|Monoclonal antibody targeting PD-1 or PD-L1
15840308|NCT04121429|Other|Observation|No intervention will be performed
15840309|NCT04121416|Drug|Oxycodone 10mg|induction with 0.3mg/kg of oxycodone in general anesthesia
15840310|NCT04121416|Drug|Sufentanil|induction with 0.3 µg/kg of Sufentanil in general anesthesia
15840311|NCT04121403|Biological|Rituximab|Biosimilar rituximab concentrate for solution for infusion
15840312|NCT04121403|Drug|Cladribine|Mavenclad oral cladribine tablets
15840313|NCT04121390|Behavioral|Newborn Parenting Class|Newborn Parenting Class designed by Mount Sinai Parenting Center. The class is 1-hour long and taught be pediatric attending and residents to all families who deliver well babies at Mount Sinai.
15840314|NCT04121377|Other|Resistance training|"Weekly sessions introducing resistance exercises and monitoring the patients acceptability. The exercises are isometric contractions, seated heel-rise and elastic band. The patient register the amount of exercise in a home exercise journal. To protect the tendon while doing range of motion of the foot, dorsiflexion is restricted beyond neutral (0 degrees of dorsiflexion). The load on the strength exercises will progress from isometric contraction without external load to strengthening exercises with 10-20 RM (RM: Repetition Maximum). Each strength exercise can progress with added weight or stronger elastic band. The Borg scale is used to guide the patient to progress or regress the load in each exercise. The recommended level being easy to hard (2-5/10). It is emphasised that the exercises must not cause sudden or severe pain in the tendon, but muscle soreness is to be expected."
15840315|NCT04121364|Device|Tetranite|Dental Adhesive for increased implant stability
15840316|NCT04121351|Other|Singing participation|Participants will follow a 15 minute protocol consisting of the components of a Singing for Lung Health class, and a short period walking on a treadmill.
15840317|NCT04121338|Procedure|Celiac ganglion block|The celiac ganglion block will be performed under CT guidance and with the patent under moderate sedation. With the patient prone the back will be prepped and draped sterility. Under CT guidance two 22 gauge needles will be placed with the tips on either side of the celiac artery. This is the location of the celiac ganglia. Liposomal bupivacaine will then be injected in that location. Maximum dose is 133 mg for 75 kg person. For lower weight patients, dose will be weight based. Then patient will be observed for 1-2 hours post procedure and then discharged to home
15840318|NCT04121338|Drug|Liposomal bupivacaine|Liposomal bupivacaine will then be injected in that location. Maximum dose is 133 mg for 75 kg person. For lower weight patients, dose will be weight based.
15840319|NCT04121325|Device|Enterra|To measure validated and subjective pain scores among patients with an existing GES device, and who have a trial of new settings directed at abdominal pain and compare their pain scores to each patient baseline symptoms, done with their previous GES settings.
15840320|NCT04121312|Behavioral|Facilitation Intervention|"See arm description"
15840321|NCT04121299|Drug|Carvedilol|Carvedilol 40mg Extended Release Once Daily
15840322|NCT04121299|Drug|Amlodipine|Amlodipine 10mg Once Daily
15840323|NCT04121286|Drug|JAB-3312|JAB-3312 will be supplied as 0.25 mg and 1.0 mg capsules.
15840324|NCT04121273|Biological|CAR-T cell immunotherapy|"Patients enrolled will recieve three different doses of the CAR-T cell every two weeks as follows:
~Dose 1: 1x10^7/m2
~Dose 2: 3x10^7/m2
~Dose 3: 1x10^8/m2
~The cell numbers are calculated according to CAR-positive T cells."
15840325|NCT04121260|Drug|Daratumumab|Participants will receive dose 1 daratumumab with 30,000 U (2000 U/mL) with rHuPH20 SC injection.
15840326|NCT04121247|Other|nonpharmacological approaches to parents of children with sickle cell disease training program|use of non-pharmacological approaches in children with sickle cell disease, parent education
15840327|NCT04121234|Other|"Exposure:  being admitted to HDU with a red code to OEWS"|High Dependency Unit, a set of predefined variables was assessed at hospital admission, HDU admission and at discharge from HDU with the aim to investigate epidemiology, clinical outcomes and risk factors for mortality in critically-ill parturients admitted to an obstetric HDU in a high volume, urban resource-limited maternity hospital
15840328|NCT04121221|Drug|GA Depot|Long acting intramuscular injection of glatiramer acetate, once every 4 weeks
15840329|NCT04121221|Other|Placebo|IM injection once every 4 weeks
15840330|NCT04121208|Drug|JNJ-40346527|Active study drug
15840331|NCT04121208|Other|Placebo|Non-active study drug
15840364|NCT04120909|Device|Cardiac resynchronization therapy|Biventricular pacing according to current standards.
15840365|NCT04120896|Behavioral|Karate group|Children in the karate group will receive the basic Goju Ryu Karate training that includes basic stances (dachi), punching (zuki), blocking (barai) and kicking techniques (keri), form training (kata), supervised sparring (kumite), and conditioning exercises (for warm up and cool down).
15840332|NCT04121195|Drug|Dose escalation|The trial will enrol virologically suppressed HIV infected volunteers who are stable on ATV/r and 2 NRTI containing ART following stringent screening to rule out evidence of renal, hepatic or gastrointestinal dysfunction which may affect the PK evaluation. A steady-state PK (PK1) sample collection shall be done on day 7 (+/-3) after enrolment. RIF will be added at standard dose (600 mg once daily) with a further PK evaluation 14 days later (PK2); due to the potential risk of sub therapeutic PI concentrations and emergence of HIV drug resistant strains, these individuals will be given DTG 50 mg twice daily for the duration of the dose-escalation study. ATV/r dose will be increased in a single step to the total modelled dose (PK3), given as twice daily doses. Once at maximum ATV/r dose, RIF will be increased to 1200 mg once a day for a further seven days (PK4). RIF will then be stopped, ATV/r stepped down to 300/100mg once a day and DTG continued for a further one week.
15840333|NCT04121182|Other|On-line training|"Nursing teams randomized in the intervention group will benefit from an intervention in the form of a specific training online on the prevention of pneumonia and their management in the nursing home This training focuses on prevention, and management during the infectious period (the false food route and the management of pneumonia)."
15840334|NCT04121182|Other|Usual practice|Nursing home with usual practice : The act of comparison is defined by the usual care, as they are performed in the nursing home at the time of the study. No restrictions are placed on residents or caregivers of any kind in the care of the resident.
15840335|NCT04121169|Drug|IM-01|Antibodies react with C. difficile toxin, C. difficile bacteria and spores; neutralizes the toxin and inhibit the growth of spores and vegetative forms of C. difficile
15840336|NCT04121156|Device|HD-tDCS treatment|2 milli Amp dose of HD-tDCS treatment for for 20 minutes, for 5 consecutive twice daily sessions
15840337|NCT04121156|Device|sham (placebo) HD-tDCS|Participants will receive sham (placebo) HD-tDCS for 20 minutes, for 5 consecutive twice daily sessions
15840338|NCT04121143|Biological|IL-17A Antagonist|SHR-1314 subcutaneous injection
15840339|NCT04121143|Biological|Placebos|placebo subcutaneous injection to maintain consistency and to prevent blindness
15840340|NCT04121130|Device|F-ESWT Group|3 F-ESWT sessions, 1 per week (0,10 mJ/mm2; 2000 impulses; 5 Hz) in the most painful tender and/or trigger points of the upper trapezius muscle.
15840341|NCT04121130|Device|sham F-ESWT|3 sham F-ESWT sessions, 1 per week (0,01 mJ/mm2; 2000 SW; 5 Hz) in the most painful tender and/or trigger points of the upper trapezius muscle.
15840342|NCT04121117|Other|Chronic obstructive pulmonary disease screening|"To verify the tobacco withdrawal, the patients will make a cooximetry.
~For the detection of a possible obstructive pattern a measurement of the ventilatory capacity will be make using the COPD-6 device and for the confirmation of COPD diagnosis and the assesment of the airflow obstruction severity a spirometry will be make.
~The patients will also complete the COPD-PS questionnaire."
15840343|NCT04121104|Other|SCS is switched off|Spinal cord stimulator is switched off for 12 hours
15840344|NCT04121104|Other|SCS is switched on|Spinal cord stimulator is on
15840345|NCT04121091|Drug|Pramipexole Pill|Add-on pramipexole
15840346|NCT04121078|Drug|TAK-906|TAK-906 capsule.
15840347|NCT04121078|Drug|Rifampin|Rifampin infusion.
15840348|NCT04121065|Procedure|Blood withdrawal|Blood withdrawal of maximum 60 ml performed to each enrolled patient during the study for primary and secondary endpoints evaluation.
15840349|NCT04121052|Drug|JNJ-64417184|Participants will receive single dose of JNJ-64417184 as oral tablet.
15840350|NCT04121039|Drug|Apatinib|Apatinib (500 mg qd p.o.) until disease progression or intolerable toxicity or refused by the patients.
15840351|NCT04121039|Drug|POF|The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days.
15840352|NCT04121026|Other|External validation of the PAANTHER TB treatment decision algorithm|"The PAANTHER algorithm will be used for a TB treatment decision by site clinicians in all children enrolled in the study. The PAANTHER algorithm and prediction score was designed as a guiding tool for empirical TB treatment decision in HIV-infected children with presumptive TB. The proposed score includes:
~history of contact
~suggestive TB symptoms
~tachycardia
~chest radiography
~abdominal ultrasound
~Xpert MTB/RIF Ultra. A score of >100 is highly predictive of TB. In children with a score >100, anti-TB treatment will be initiated immediately. In children with a score of <100, TB treatment will not be initiated except in those with severe/life-threatening conditions for whom TB treatment decision could be made at the discretion of the site clinician. TB could be definitely ruled out after further assessment and decision made as to what treatment the children should receive in accordance with existing national protocols, along with clinical follow-up."
15840353|NCT04121013|Other|mothership|Randomized controlled study: allocation to active or no intervention arm will be done accordingly to the design temporal sequence
15840354|NCT04121000|Procedure|VIDEO ASSISTED THOTACOSOPIC SURGERY|VATS
15840355|NCT04120987|Drug|Lifitegrast 5% Ophthalmic Solution|BID OU
15840356|NCT04120974|Behavioral|Optimal insulin injection|subjects receive training in optimal injection technique.
15840357|NCT04120961|Drug|prolonged continuous use of bivalirudin|prolonged continuous use of bivalirudin 4 hours after elective PCI (dose: 0.75 mg/kg bolus plus 1.75 mg/kg per hour)
15840358|NCT04120961|Drug|bivalirudin use during ePCI|bivalirudin use during ePCI (0.75 mg/kg bolus plus 1.75 mg/kg per hour)
15840359|NCT04120948|Device|Waterlase Express Laser System|10-minute treatment with the Waterlase Express (Biolase, Irvine CA). The dorso-posterior surface of the tongue is treated with the laser in 10 passes of 60 seconds each with 10 seconds of rest in between. Laser settings were 60μs pulse width, 4W, 40Hz, 10% air and 5% water irrigation. An MC12 sapphire laser tip (Biolase, Irvine CA) is held 3mm away from the tongue in a constant sweeping motion during treatment with passes overlapping passes in alternate direction, side to side motion and front to back motion with laser fluence on the tongue surface calculated at 3J/cm2. The settings were non ablative and non thermal.
15840360|NCT04120948|Device|Tongue scraper|mechanical scraping of the dorso-posterior surface of the tongue
15840361|NCT04120935|Other|Observation|Prospective Observation of standard clinical practice.
15840362|NCT04120922|Other|calcium carbonate|See arm description
15840363|NCT04120922|Other|sevelamer carbonate|See arm description
15840444|NCT04120311|Drug|Episcleral Dexamethasone|Sustained Release Episcleral Dexamethasone
15840366|NCT04120896|Behavioral|Kung fu group|Children in the Ving Tsun kung fu group will receive the basic Wong Shun Leung style Ving Tsun training that includes basic stances (ma), footwork (bu), punching (quan), kicking (jie) techniques and conditioning exercises (for warm up and cool down).
15840367|NCT04120883|Drug|Hydroxychloroquine lower dose|The participants weight will be measured and converted to kilograms. The participants will receive 4 mg/kg/day. At the first follow-up visit (4 months) weight will be re-measured and the study drug dosing will be adjusted accordingly if the dosing has changed. Participants receiving 100 mg daily will be instructed to ingest one 200 mg tablet every other day. Participants receiving 200 mg daily will be instructed to ingest one 200 mg tablet daily. Participants receiving 300 mg daily will be instructed to alternate days ingesting two 200 mg tablets and one 200 mg tablet. Participants receiving 400 mg daily will be instructed to ingest two 200 mg tablets daily.
15840368|NCT04120883|Drug|Hydroxychloroquine higher dose|"The start of intervention for treatment arm 2 of the study will be delayed until preliminary safety of the drug is established with the 6 patients in treatment arm 1 at the first follow-up visit (4 months).
~The participants in this group will receive 5 mg/kg/day. At the first follow-up visit (4 months) weight will be re-measured and the study drug dosing will be adjusted accordingly if the dosing has changed. Participants receiving 100 mg daily will be instructed to ingest one 200 mg tablet every other day. Participants receiving 200 mg daily will be instructed to ingest one 200 mg tablet daily. Participants receiving 300 mg daily will be instructed to alternate days ingesting two 200 mg tablets and one 200 mg tablet. Participants receiving 400 mg daily will be instructed to ingest two 200 mg tablets daily."
15840369|NCT04120870|Drug|Etomidate Injection 0.2 mg/kg|The induction agent of rapid sequence intubation is etomidate. 0.2 mg/kg
15840370|NCT04120870|Drug|Ketamine injection 2 mg/kg|The induction agent of rapid sequence intubation is ketamine. 2 mg/kg
15840371|NCT04120857|Behavioral|Gentle Stretching|60 minutes fo gentle stretching twice weekly for 8 weeks
15840372|NCT04120844|Behavioral|Motivational interviewing (MI)-based patient empowerment program (PEP)|Motivational interviewing (MI) is a collaborative, patient-centered counseling approach that aims to elicit behavior change. Counselors use empathy and other techniques to create an atmosphere to help patients to explore the discrepancies between the goals and their current behavior. The focus of MI is to find and resolve the ambivalence, improve patients' perception of the importance of behavior change, and support them to make the change. MI provides a structural framework with guiding principles that can be easily followed by the primary care doctors. Program content was further informed by the Hospital Authority Patient Empowerment Program in Hong Kong. The education program consisted of four modules, held once a week, that each lasted approximately 1½ to 2 hours. They were grouped under the following four broad headings: Knowing Diabetes, Diabetes Self-Care, Healthy Diet and Physical Exercise.
15840373|NCT04120844|Behavioral|Traditional lecture style health education|The control group received traditional lectures that consisted solely of conveying healthcare information to patients. In order to minimize intervention bias, the control group lectures were standardized and adapted into four modules, namely knowing diabetes, healthy diet, physical exercises, and how to use medication correctly, which were similar topic headings, durations and frequencies to those of the intervention group. Each lecture was 1 hour and was provided by one of four health professionals (a pharmacist, dietician, endocrinologist or nurse) who had never received any prior training in MI. We consciously avoided the inclusion of elements of self-reflection and motivation in these lectures.
15840374|NCT04120831|Drug|Abatacept Injection|Drug
15840375|NCT04120818|Procedure|secondary IOL implantation|reopened the fibrotic, closed capsular bag and achieve IOL placement
15840376|NCT04120818|Procedure|primary IOL implantation|lensectomy and anterior vitrectomy and primary IOL implantation
15840377|NCT04120805|Device|Hemostatic Agent|Patients undergoing robotic-assisted laparoscopic partial nephrectomy with the use of hemostatic agents by a surgeon
15840378|NCT04120805|Other|No Hemostatic Agent|Patients undergoing robotic-assisted laparoscopic partial nephrectomy without the use of hemostatic agents by a surgeon
15840379|NCT04120792|Behavioral|Simultaneous exercise and cognitive training|Participants in this arm will engage in a 12-week intervention that combines physical exercise and cognitive tablet-based training. This intervention involves use of an exercise bicycle while engaging in cognitive tasks on a tablet computer three times per week.
15840380|NCT04120792|Behavioral|Exercise training|Participants in this arm will engage in a 12-week exercise intervention that involves use of an exercise bicycle three times per week.
15840381|NCT04120792|Behavioral|Cognitive Training|Participants in this arm will engage in a 12-week intervention that involves cognitive tablet-based training three times per week.
15840382|NCT04120792|Behavioral|Neutral video|Participants in this arm will engage in a 12-week intervention that involves watching neutral videos on a tablet computer three times per week.
15840383|NCT04120779|Device|The EMPOWER-SUSTAIN e-Health Self-Management Intervention|Multifaceted chronic disease management strategies involving web-based self-management intervention mobile apps based on chronic care model and persuasive technology theory to improve patient activation and self-management behaviours among patients with metabolic syndrome.
15840384|NCT04120766|Drug|Nicorandil|20 mg po qd
15840385|NCT04120766|Drug|Placebo|Matching tablet
15840386|NCT04120753|Drug|OLOMAX 20/5/5mg|Tablets, Oral, QD
15840387|NCT04120753|Drug|OLOMAX 20/5/10mg|Tablets, Oral, QD
15840388|NCT04120753|Drug|Olmesartan 20 mg/Amlodipine 5 mg|Tablets, Oral, QD
15840389|NCT04120714|Device|Active tDCS|active D.C. transcranial stimulation (delivers a low current (1 to 2 mA)) for 10 to 30 minutes, during 5 sessions
15840390|NCT04120714|Device|Placebo tDCS|inactive DC transcranial stimulation (delivering a non-significant current at the beginning and end of the stimulation, simulating active stimulation) for 10 to 30 minutes, during 5 sessions
15840391|NCT04120714|Other|Questionnaires|"visual analogue scale (VAS)
~impulsivity scale: Barratt Impulsiveness Scale - version 11 (BIS-11)
~Decision-making scales: Iowa Gambling Task (IGT) and Balloon Analogue Risk Task (BART)
~Go-No go test
~HAM-D scale
~SF-12 quality of life scale"
15840393|NCT04120688|Device|3D generated tooth replica|3D generated tooth replicas are compared to conventional procedure
15840394|NCT04120675|Dietary Supplement|Early Harvest Extra Virgin Olive Oil|Participants will take 3 tablespoons on a daily basis
15840395|NCT04120662|Procedure|Intramedullary screw fixation|A Kirschner wire was introduced in the proximal tuberosity under anteroposterior and lateral fluoroscopic control, following the bone axis and passing through the fracture line; a cannulated compressor screw in a diameter between 45 - 55 mm in the more satisfactory position to achieve the optimal fragments compression.
15840396|NCT04120662|Device|Focused Shock Wave Treatment|3 weekly session, one per week, of focused shock waves, using an electrohydraulic device.
15840397|NCT04120649|Procedure|hysterectomy|total hysterectomy, bilateral salpingo-oopherectomy (based on the age of the patient), pelvic and para-aortic lymphadenectomy, and peritoneal washings
15840398|NCT04120636|Drug|Episcleral Celecoxib|Sustained Release Transscleral Celecoxib
15840399|NCT04120623|Drug|Dapagliflozin 10 MG|Dapagliflozin 10 MG combined with Insulin Aspart infused by continuous subcutaneous insulin infusion ( CSII).
15840400|NCT04120623|Drug|Insulin Aspart|Insulin Aspart is infused through continuous subcutaneous insulin infusion ( CSII)
15840401|NCT04120610|Diagnostic Test|FlowMet-R|FlowMet-R is a noninvasive blood flow measurement.
15840402|NCT04120610|Diagnostic Test|ABI|Ankle Brachial Index is a ratio-metric blood pressure measurement in the ankle and arm.
15840403|NCT04120610|Diagnostic Test|TBI|Ankle Brachial Index is a ratio-metric blood pressure measurement in the toe and arm.
15840404|NCT04120597|Drug|Zishen Qingre Lishi Huayu Granules|The treatment group used Zishen Qingre Lishi Huayu Granules, including Zhimu（Anemarrhena asphodeloides Bge.）, Shengdi（Rehmannia glutinosa Libosch.）, Maidong（Ophio pogon japonicus (L.f) KerGawl.） , Bixie（Dioscorea septemloma Thunb.）, Huanglian（Coptis chinensis Franch.）, Zhuling（Polyporus umbellatus（Pers.）Fries）, Xuanshen（Scrophularia ningpoensis Hemsl.）, Zelan（Lycopus lucidus Turcz. Var. Hirtus Regel）, Danshen（Salvia miltiorrhiza Beg.）， Gancao（Glycyrrhiza uralensis Fisch.）. Subjects take the drug from the first day of inclusion. Take 1 pack each time, bid, for 3 months.
15840405|NCT04120597|Drug|Placebo|"The treatment group used Caramel pigment、 Ku Ding Cha Extracts、Maltodextrin、Starch and 5% Zishen Qingre Lishi Huayu Granules .
~Subjects take the drug from the first day of inclusion. Take 1 pack each time, bid, for 3 months."
15840406|NCT04120584|Device|Forma Eye Applicator|"Eligible subjects will receive up to 3 treatments (2-3 weeks interval) with the Forma Eye Applicator according to the study protocol.
~The subject will return for 3 follow up visits: four weeks (4wk FU), 12 weeks (12wk FU), twenty-four weeks (24wk FU) after the last treatment."
15840407|NCT04120571|Other|Sleep Audiological Intervention Device (SleepAID)|subtle sound stimulation in phase with the slow oscillations
15840408|NCT04120571|Other|sham control|no noise
15840409|NCT04120558|Other|Qualitative interviews and focus groups|"Semi-structured interviews will be undertaken with at least 24 and up to as many as 36 through knee and above knee amputees. A topic guide will be used to interview participants about perceived functional ability, body image, adapting post amputation and overall quality of life. A sampling frame will be used to ensure a range of views are sought (e.g. both men and women with through and above knee amputations; and with different mobility levels). Thematic analysis will be used to analyse the data. Focus group discussions will be informed by the findings of the interviews.
~The themes that emerge from the semi-structured interviews will be further explored using focus groups and allow for comparison of the experiences between through knee and above knee amputees."
15840410|NCT04120558|Other|Functional mobility tests and questionnaires|"Function in sitting and sit-and-reach will be assessed in non-ambulatory (wheelchair users) individuals. An overall score for each sitting activity will be recorded and the distance reached will be calculated.
~Walking, timed-up-and-go, L-test, balance in sitting and standing, seated activities will be assessed in ambulatory (prosthetic using) individuals. The time taken, distance walked, distance reached, and the overall scores for each activity will be compared between the two groups. Fear of falls and confidence levels when performing tasks will be investigated using two questionnaires.
~The EQ-5D-5L and SF-36 will be issued to the non-ambulatory and ambulatory participants to complete when attending the testing session.
~The Locomotor Capability Index - 5 (LCI-5), Activities-specific Balance Confidence Scale (ABC-UK) and Houghton scale of prosthetic use in people with lower-extremity amputations"
15840411|NCT04120545|Device|Microcurrents|"The electrodes will be placed with the help of gloves and adapted socks for 1 hour, twice a week, until 10 intervention sessions are completed. In addition, depending on the session, an adhesive electrode will be placed at the level of C7, L3 or S1.
~Characteristics of microcurrents: pulsed monophasic rectangular wave with a pulse of 1.3 s and pause of 300 ms, voltage 3 mV and intensity 0.5 μA."
15840412|NCT04120545|Device|Placebo Microcurrents|The same protocol described for the experimental group will be applied, but microcurrents device which will be previously manipulated and tested with an oscilloscope so that they do not emit electrical currents
15840413|NCT04120532|Behavioral|Perioperative Rehabilitation|Physical therapist will be consulted one day before and after the operation (OP) day. On the day before the OP day, they focus on education, including how to get up from bed and stand up from a chair. Five rehabilitation exercises are also demonstrated: 1) ankle flexion and extension, 2) knee flexion and extension, 3) hip joint abduction and adduction, 4) hip joint flexion and extension, and 5) drawing-in maneuver. The participants will be required to repeat each component to confirm that they can do it correctly. Each exercise is suggested to be done 10 times per day following MI-TLIF, and the number will be recorded 3 days (pre-OP day, post-OP day, and post-OP day 2).
15840414|NCT04120519|Drug|thalidomide combined with dexamethasone and cyclophosphamide|TCD
15840415|NCT04120506|Drug|VPRIV|Safety, pharmacokinetics, and efficacy of rapid intravenous infusion of velaglucerase alfa (VPRIV) in adult patients with type 1 Gaucher disease
15840416|NCT04120493|Genetic|intra-striatal rAAV5-miHTT|One time MRI-guided stereotaxic infusion of rAAV5-miHTT into the brain
15840417|NCT04120493|Other|Imitation (sham) surgery|Simulated surgical procedure with skin incisions only; no intrastriatal injections and no burr holes through the skull
15840445|NCT04120298|Behavioral|Supervised exercise|An individualised exercise programme supervised by a trained instructor
15840446|NCT04120285|Behavioral|remote internet-based cognitive behavior therapy (eCBT)|Provide access to online psychotherapy program to participants in rural WV areas at no expense to them.
15840447|NCT04120272|Procedure|Spine surgery|Eligible Surgeries: lumbar spine fusion surgery, posterior cervical spine fusion surgery, or anterior cervical spine fusion surgery
15840448|NCT04120259|Drug|Metformin Oral Tablet|A biguanide drug used as a first line therapy for Diabetes MellitusType 2
15840418|NCT04120480|Diagnostic Test|Pharmacogenomic test|The RightMed test is an end-to-end solution which includes sample collection, PGx testing services, data analysis, and clinical interpretation that helps prescribers select treatments based on evidence-driven predictions of patient drug response and tolerance. Genetic components of an individual's drug response are well established and often included on FDA medication labels. The RightMed test has incorporated existing evidence to classify the risk and likelihood of an antidepressant working for different patients. Patient results for each medication can fall into one of three categories: 1) Green - use as directed; 2) Yellow - use with caution; and 3) Red - adjust dose or choose alternative mediation.
15840419|NCT04120467|Other|Dance|"One group will receive a 60-minute dance class weekly over a 6 weeks period. A physiotherapist - dance teacher will lead the classes, supported by at least one volunteer.
~The class structure will consist of five components: warm up (10 minutes), technical exercises (10 minutes), improvisation (15 minutes), a short routine (15 minutes) and a cool down/feedback time (10 minutes). Dance exercises will be targeting flexibility, balance, endurance, upper and lower limbs functions, interaction between dancers, perception and memory. Using choreography or short routine, the class will include repeating the dance moves - which fosters memorization - and also the additional challenge of remembering a sequence of moves.
~Given the great variability of each participant's functional ability, the complexity and the intensity of the dance exercises will progress according to each participant's capacity, in order to fulfill an appropriate challenge at moderate treatment intensity."
15840420|NCT04120467|Other|Standard rehabilitation|The control group will have conventional rehabilitation as usually planned in the rehabilitation center: 45 to 60 minutes of physiotherapy per day integrating sensory stimulation, motor activation, strengthening, coordination, balance and exercise training. Patients also receive 45 to 60 minutes of occupational therapy per day.
15840421|NCT04120454|Biological|Pembrolizumab|Given IV
15840422|NCT04120454|Biological|Ramucirumab|Given IV
15840423|NCT04120441|Behavioral|Group Mentoring/Intervention|Study participants randomized to intervention will be enrolled in a Y in Central Maryland group mentoring program that meets weekly over a three month period. Parents will participate in three parenting sessions.
15840424|NCT04120428|Other|Aquatic exercise training program|The intervention will be performed in a pool in which the water surface line will remain in the imaginary line of the xiphoid process. Each season will last 50 minutes and will be divided in 3 phases as (1) warm-up (15 minutes), (2) main part (30 minutes) and (3) cool-down (5 minutes).
15840425|NCT04120415|Biological|Vaccine and vedolizumab (Entyvio)|"Vaccine and vedolizumab infusion (Entyvio):
~0.5ml of MVA HIV-B (1 x 108 pfu/ml) will be administered intramuscularly in the deltoid muscle of the non-dominant upper arm at weeks 0 and 8. Participants will be observed after the injection.
~Vedolizumab (300mg) is administered as an intravenous infusion (255 ml) over 30 mins in the dominant arm at weeks 10,12,16,20,24,28 and 32. After infusion, the line should be flushed with 30ml of normal saline. Participants will be observed throughout and after the infusion."
15840426|NCT04120415|Biological|Placebo vaccine and vedolizumab infusion (Entyvio)|"Placebo Vaccine:
~The placebo for MVA HIV-B to be used is a solution composed of S08 buffer (as for the MVA vaccine) that will be intramuscularly in the deltoid muscle of the non-dominant upper arm at weeks 0 and 8. Participants will be observed after the injection.
~Vedolizumab infusion (Entyvio):
~Vedolizumab (300mg) is administered as an intravenous infusion (255 ml) over 30 mins in the dominant arm at weeks 10,12,16,20,24,28 and 32. After infusion, the line should be flushed with 30ml of normal saline. Participants will be observed throughout and after the infusion."
15840427|NCT04120415|Biological|Placebo vaccine and placebo infusion|"Placebo Vaccine:
~The placebo for MVA HIV-B to be used is a solution composed of S08 buffer (as for the MVA vaccine) that will be intramuscularly in the deltoid muscle of the non-dominant upper arm at weeks 0 and 8. Participants will be observed after the injection.
~Placebo infusion (Entyvio):
~255ml Sodium Chloride (NaCl) 0.9% bag administered as an intravenous infusion over 30 mins in the dominant arm at weeks 10,12,16,20,24,28 and 32. Participants will be observed throughout and after the infusion."
15840428|NCT04120402|Drug|EP-104IAR 25 mg|Single 5 mL intra-articular injection
15840429|NCT04120402|Drug|Vehicle|Single 5 mL intra-articular injection
15840430|NCT04120389|Device|bandage contact lenses(PureVision; Bausch & Lomb Inc., Rochester, NY)|wear an bandage contact lenses for a week after Complicated and Combined cataract surgery.
15840431|NCT04120389|Procedure|phacoemulsification|underwent standard phacoemulsification through a 2.8-mm clear corneal temporal incision and intraocular lens
15840432|NCT04120376|Behavioral|Contraception Counseling|Each participant will receive a 10 minute confidential contraception counseling session with an Advanced Practice Provider in the Emergency Department
15840433|NCT04120363|Drug|Testosterone Undecanoate|single intramuscular injection of 750 mg testosterone undecanoate
15840434|NCT04120363|Drug|Sesame Oil|single intramuscular injection of 3 ml sesame oil solution
15840435|NCT04120350|Drug|Methotrexate|3.5g/m2 intravenous infusion for 4 hours in d1, every 21 days for 1 cycle. 6 cycles will be prescribed as protocol
15840436|NCT04120350|Drug|Rituximab|375mg/m2 intravenous infusion d1, every 21 days for 1 cycle. 6 cycles will be prescribed as protocol
15840437|NCT04120350|Drug|Lenalidomide|"In phase 1b study, a 3+3 design dose- escalation will be taken. 3 levels should be tested, 15/20/25mg orally d1-14, every 21 days for 1 cycle. 6 cycles will be prescribed as protocol.
~[update 02-Jun-2020: the phase Ib trial has finished,and no MDT was obsevered in 25mg group. So the recommanded phase II dose was 25mg.] In phase II study, 25mg daily is considered as an experiment dose for the induction cycles.
~In both phase Ib and II study, the does of lenalidomide maintenance is fixed to 25mg orally d1-21 every 28 days for 1 cycle. The duration of maintenance is 2 years."
15840438|NCT04120337|Device|RemovAid device + lidocaine patch|The RemovAid device incises the skin and grasps the implant for removal. A lidocaine patch will be used prior to incision.
15840439|NCT04120337|Procedure|Standard technique + lidocaine injection|Using scalpel, tweezers, and forceps to remove a subdermal implant. A lidocaine injection will be used prior to incision.
15840440|NCT04120337|Device|RemovAid device + lidocaine injection|The RemovAid device incises the skin and grasps the implant for removal. A lidocaine injection will be used prior to incision.
15840441|NCT04120324|Other|Eligible for Same Day Discharge|Preoperative Physiotherapy and Anesthesia Criteria met.
15840442|NCT04120324|Procedure|Primary Single Joint Total Hip Arthroplasty|Total Hip Replacement Surgery
15840443|NCT04120324|Other|Discharge Same Day|Postoperative criteria for Same Day Discharge met.
15840449|NCT04120259|Dietary Supplement|Vinegar|A common herbal/dietary supplement used for centuries as an anti bacterial, cleaning,cooking, anti diabetic agent, to name a few uses.
15840452|NCT04120233|Drug|Placebo|Matched placebo administered orally
15840453|NCT04120233|Drug|MW151, 10mg|10 mg MW151, 1 x 10mg capsule administered orally
15840454|NCT04120233|Drug|MW151, 20mg|20 mg MW151, 1 x 20mg capsule administered orally
15840455|NCT04120233|Drug|MW151, 40mg|40 mg MW151, 2 x 20mg capsule administered orally
15840456|NCT04120233|Drug|MW151, 80mg|80 mg MW151, 1 x 80mg capsule administered orally
15840457|NCT04120233|Drug|MW151, 160mg|160 mg MW151, 2 x 80mg capsule administered orally
15840458|NCT04120220|Other|Heavy Cream|Participants will receive a meal in the form of a fruit-containing shake containing 30 g of fat prepared with heavy cream.
15840459|NCT04120220|Other|Soybean Oil|Participants will receive a meal in the form of a fruit-containing shake containing 30 g of fat prepared with soybean oil.
15840460|NCT04120207|Behavioral|Home-based Pilates|The Home-based Pilates group will complete two Pilates classes at home, twice weekly, for a period of eight weeks.
15840461|NCT04120207|Other|Delayed-start Pilates|The Delayed-start group will maintain their regular daily activities, and be provided with a copy of the Pilates DVD following the intervention, for their own use.
15840462|NCT04120194|Biological|NanoFlu|Investigational quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
15840463|NCT04120194|Biological|Fluzone Quadrivalent|Licensed quadrivalent seasonal influenza vaccine for the 2019-20 Northern hemisphere influenza season.
15840464|NCT04120181|Other|There is no intervention.|There is no intervention.
15840465|NCT04120168|Genetic|Laboratory Tests|"Acid Alpha IgGlucosidase alpha enzyme test for Late Onset Pompe Disease and gene sequencing test from the same sample in samples with low enzyme activity
~Genetic Analysis for DMD (only in boys): Detection of dystrophin gene for duplication and deletion with MLPA (Multiplex-ligation dependent probe amplification) and re-screening for other mutations by gene sequencing in patients without MLPA deletion / duplication."
15840466|NCT04120155|Procedure|Dissection of the Inferior Pulmonary Ligament|Patients will be categorized into two groups: the division group ,who will receive the division of the inferior pulmonary ligament, and the preservation group, who will not.For the dissection group, we will dissect the inferior pulmonary ligament during the surgery.
15840467|NCT04120155|Procedure|Preservation of the Inferior Pulmonary Ligament|Patients will be categorized into two groups: the division group ,who will receive the division of the inferior pulmonary ligament, and the preservation group, who will not.For the preservation group, we will preserve the inferior pulmonay ligament during the surgery.
15840468|NCT04120142|Other|Pulmonary rehabilitation+IMT|The experimental group receives inspiratory muscle training and aerobic exercise.
15840469|NCT04120142|Other|Pulmonary rehabilitation|The Active Comparator group received only aerobic exercise.
15840470|NCT04120129|Device|TMS|Transcranial Magnetic Stimulation (TMS) is a noninvasive brain stimulation technique which produces short pulsatile magnetic fields (similar to that of an MRI) via two extracranial, figure 8-shaped electric coils which can induce a small, temporary, electric current in the brain currently approved and used for depression.
15840471|NCT04120129|Device|sham TMS coil|The sham TMS does cause some stimulation to the participant so that the participants get the sensation of treatment without any cortical excitation that TMS delivers. The sensation experienced is similar to the muscle twitching or finger tapping experienced by TMS participants.
15840476|NCT04120103|Behavioral|Doll therapy|The patient will then be given the doll to be used in the research by the caregiver and the researcher. Intervention group (accepting the baby) will be evaluated in terms of interaction with the baby, communication with employees and other patients and participation in daily life activities for 60 days. In addition, the agitation symptoms of the patients during the 60 days they spend with the baby will be evaluated by CMAI and cognitive level by MMSE.
15840477|NCT04120103|Other|Routine nursing care|The nursing care provided by the institution was applied to the dementia patients in the routine nursing care group. Routine nursing care group interventions in the institution; Monitoring of life signs, application of drug treatments, participation in social activities such as listening to music, reading prayer, initiatives such as assisting patients in performing daily living activities.
15840478|NCT04120090|Drug|low dose ruxolitinib|The dose for adult patients(Age>=14 years) is generally 10 mg twice daily. For children(Age<14 years ,weight >=25kg),the dose was generally 5mg twice daily. For children(Age<14 years, weight <25kg), the dose was generally 2.5mg twice daily.
15840479|NCT04120090|Drug|high dose ruxolitinib|The dose for adult patients(Age>=14 years) is generally 20mg twice daily. For children(Age<14 years ,weight >=25kg),the dose was generally 10mg twice daily. For children(Age<14 years, weight <25kg), the dose was generally 5mg twice daily
15840480|NCT04120077|Dietary Supplement|EyePromise DVS, EyePromise DVS plus EyePromise EZTears|Placebo Comparator: American Association of Diabetes Educators (AADE) certified Diabetes Self-Management Education (DSME) with placebo nutritional supplements
15840481|NCT04120064|Drug|Cholecalciferol|Large, one time dose of 300,000 IU oral cholecalciferol or daily 5,000 IU oral cholecalciferol
15840482|NCT04120051|Dietary Supplement|Fermented canola-seaweed|A daily sachet with 5 gram FCS-granulate for 6 weeks
15840483|NCT04120051|Other|Placebo|A daily sachet with 5 gram rye cereal for 6 weeks
15840484|NCT04120038|Device|Self-Management for Amputee Rehabilitation using Technology [SMART]|Participants will complete a 6-week tablet-based education program for individuals with LLA that will provide them with self-management education.
15840485|NCT04120025|Behavioral|Diaphragm Training|training on isolated abdominal breathing with proper effort and hold time to promote strengthening
15840521|NCT04119739|Drug|Ibuprofen|Oral tablets
15840714|NCT04118036|Drug|Pembrolizumab|intravenously over 30 minutes every 21 days (+/- 3 days)
15840486|NCT04119999|Device|Mandibular Advancement Device|Mandibular advancement device (MAD) has been a novel method in the management of snoring and OSA. For mild to moderate sleep apnea, MADs have been a boon. A guideline published by American Academy of Sleep Medicine stated that MAD was indicated as first-line therapy for mild OSA and a second-line therapy for moderate to severe OSA
15840487|NCT04119999|Device|Continuous Positive Airway Pressure|Continuous positive airway pressure (CPAP) is a form of positive airway pressure ventilator, which applies mild air pressure on a continuous basis to keep the airways continuously open in people with OSA
15840488|NCT04119986|Device|drug coated balloon|Balloon/vessel diameter ratio 0.8-1.0, 8-12 ATM (atmosphere), lasting for >30 seconds.
15840489|NCT04119986|Device|drug eluted stent|with regular techniques
15840490|NCT04119973|Other|standard treatment|standard medical treatment
15840491|NCT04119960|Device|Aided read with InferRead Lung CT.AI|Radiologists read chest CT scans with the aid of InferRead Lung CT.AI
15840492|NCT04119947|Drug|SY-009|The study will be initiated in healthy subjects at a 0.5mg dose that is the maximum recommended starting dose(MRSD) . Doses will be escalated in subsequent dosing process, after appropriate review of safety data. The subsequent planned doses are 2,5, 10, 20, 40mg successively. The increment of the dose escalation may be reduced, a lower dose may be administered following data review.
15840493|NCT04119934|Behavioral|Smoking Cessation Intervention Tool|A personalized smoking cessation infographic is provided to the physician alongside the patient's regular spirometry report.
15840494|NCT04119921|Drug|prescription topical ketorolac in group 1|topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval.
15840495|NCT04119921|Drug|prescription artificial tear in group 2|artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval.
15840496|NCT04119921|Drug|prescription topical ketorolac in group 2|artificial tear every 6 hour in the first interval and then topical ketorolac every 6 hour as a placebo in the second interval.
15840497|NCT04119921|Drug|prescription artificial tear in group1|topical ketorolac every 6 hour in the first interval and then artificial tear every 6 hour as a placebo in the second interval.
15840498|NCT04119908|Device|Sublingual videomicroscopy|Measurement of sublingual capillary density by video microscopy
15840499|NCT04119908|Biological|blood sample|Collection of citrate tubes of 5 mL at baseline and at 36 months
15840500|NCT04119895|Other|Neuromuscular electrical stimulation and core stabilization exercise|"In NMES group, the amplitude of the electrical current will be set at the highest level subject can tolerate.
~The lumbar stabilization mode of the device will be used. This mode consists of three phases; warming, contraction and recovery phases. The duration will be set to 35 minutes. In the first 2 minutes (warming phase), frequency is 6 Hz. Contraction phase includes consecutive cycles of contractile frequency of 40 Hz for 6 seconds and the rest frequency of 4 Hz for 12 seconds, lasting a total of 30 minutes. The last 3 minutes (recovery phase) frequency is 3 Hz. The ramp up time is 2 seconds and the ramp down time is 1 second"
15840501|NCT04119895|Other|Sham neuromuscular electrical stimulation and core stabilization exercise|In sham NMES group, the amplitude of the electrical current will be set at a minimum level which does not stimulate any contraction.
15840502|NCT04119882|Diagnostic Test|Blood collection|New biomarker test
15840503|NCT04119869|Other|iaya|The iaya app is a smartphone application intervention that -through a variety of approaches, such as exercises aimed at identifying and changing thoughts and behaviors, imagery, and relaxation- seeks to enhance coping with the emotional impact of cancer.
15840504|NCT04119856|Other|Affiliation with the outgoing lung team|"The work of the outgoing lung team takes place in the patient's home and involves the following:
~The outgoing lung team teaches the patients, relatives and primary care staff about symptoms, treatments and instructions related to COPD.
~The patients, relatives and primary care staff can contact the outgoing lung team by telephone day and night.
~The patients report symptoms and measurements to the outgoing lung team using telemedicine as patient reported outcomes.
~The outgoing lung team initiates appropriate treatment by telephone or a home visit. The outgoing lung team always consults a doctor from the Department of Respiratory Diseases and Allergy before initiating treatment.
~The outgoing lung team initiates acute consultations at Department of Respiratory Diseases and Allergy based on patient reported outcomes, home visit or telephone call."
15840505|NCT04119843|Drug|Mangoral|800 mg manganese chloride [II] tetrahydrate, 500 mg L-alanine, and 800 IU vitamin D3
15840506|NCT04119830|Biological|Pembrolizumab|Given IV
15840507|NCT04119830|Other|Questionnaire Administration|Ancillary studies
15840508|NCT04119830|Drug|Rintatolimod|Given IV
15840509|NCT04119817|Dietary Supplement|Mucosave® capsules|400 mg/day of Mucosave® capsules for a period of 8 weeks, once a day.
15840510|NCT04119817|Dietary Supplement|Placebo|400 mg/day of placebo capsules for a period of 8 weeks, once a day.
15840511|NCT04119804|Diagnostic Test|cellular neural networks-genetic algorithm|Cellular neural networks-genetic algorithm applied to conventional radiographs of hip implants with a well-established diagnosis of loosening. The study is not intended to use a software without a CE mark as a medical device, or to use the software as a tool to diagnose or prevent human disease, according to Directive 93/42 / European Economic Community. The study will evaluate if the software, properly calibrated, is able to recognize with adequate accuracy infections already diagnosed with validated methods.
15840512|NCT04119791|Other|wild rice|30 grams of wild rice in the form salad, snack bar and soup
15840513|NCT04119778|Behavioral|Aerobic Exercise, Tai chi|They are aerobic and mind-body exercise respectively.
15840514|NCT04119765|Biological|Blood sampling|blood sampling will be used to perform oxalemia and FGF23 quantitative analysis
15840515|NCT04119765|Biological|Urine sampling|urine sampling will be used to measure glycolate urinary rate (glycolaturia) and to perform urinary inflammation markers quantitative analysis
15840516|NCT04119765|Procedure|Pulse Wave Velocity (PWV) measurement|PWV will be measured thank to the Complior® device
15840517|NCT04119765|Procedure|central pressure measurement|central pressure will be measured thank to the Complior® device
15840518|NCT04119752|Dietary Supplement|Curcumin powder|10g of curcumin powder
15840519|NCT04119752|Dietary Supplement|Placebo|1g of sucralose
15840520|NCT04119739|Other|Median nerve neural mobilization|Manual therapy maneuver performed in the upper limb.
15840522|NCT04119726|Behavioral|Usual Text Messages|Regular messages about prevention and cure of CHD will be sent to both groups four times a week. The short texts will be selected from the guidelines in China to avoid misinformation. There are also some pictures or videos that help patients change their behaviour.
15840523|NCT04119726|Behavioral|Personalized reminders|Personal information, life behavior and risk factors will be registered when patients are enrolled. According to the baseline information, personalized knowledge will be sent to patients in the intervention group. Besides, patients will receive drug information and regular medication adherence reminders daily according to patients' baseline prescription drugs and modifications.
15840524|NCT04119726|Behavioral|Internet-based counselling|"The internet-based counselling is the key module of social media in the intervention group. The consultation content mainly includes the feedback of coronary heart disease secondary prevention drug compliance, the feedback of risk factor level control, the feedback of life and behaviour habits, the feedback of adverse events, the feedback of health education knowledge improvement, the reminders of data upload, behaviour change, and health education learning.
~When the patient has questions or discomfort during the medication, they can consult the applet and the applet will perform internet-based answers on the large database built by cardiologists. Meanwhile, social media will upload the question of consultation and report to the doctor according to individual differences in disease. If the patient is not satisfied with the auto-response, the patient can further consult his doctor and the doctor's response will be collected to improve the auto-response database"
15840525|NCT04119700|Procedure|Muco-muscular endorectal advancement flap after fistulectomy|After fistulectomy muco-muscular flap of the rectal wall will be mobilized. The muscular defect is sutured with separate interrupted sutures (Vicryl / Polysorb 2/0, 0/0, 3/0). The muco-muscular flap is fixed to the anoderm without tension by interrupted sutures (Vicryl / Polysorb 4/0). The wound of the perianal area is not sutured.
15840526|NCT04119700|Procedure|Primary sphincter reconstruction after fistulectomy|Fistulectomy will be performed. The affected gland is visualized and removed. If there are secondary extensions, they are excised also. Sphincter defect with stitches (suture material Vicryl / Polysorb 2/0, 0/0, 3/0) with restoration of the anal canal profile (suturing of the anodermal-skin border). The skin is not suturing.
15840527|NCT04119687|Biological|FX201|FX201, humantakinogene hadenovec, is a novel interleukin-1 receptor antagonist (IL-1Ra) gene therapy for IA administration that is being developed for the treatment of patients with OAK.
15840528|NCT04119674|Biological|Anlotinib|Anlotinib With STUPP Regimen
15840529|NCT04119674|Drug|Temozolomide Capsule|Anlotinib With STUPP Regimen
15840530|NCT04119661|Device|Max-i-Probe|Using Max-i-Probe as endodontic needle during syringe irrigation
15840531|NCT04119661|Device|NaviTip|Using NaviTip as endodontic needle during syringe irrigation
15840532|NCT04119648|Behavioral|CAMS-4Kids|The Collaborative Assessment and Management of Suicidality (CAMS-Jobes, 2006; 2016) is an evidence-based, therapeutic framework for addressing suicide risk in the adult population. CAMS-4Kids, the research intervention used in this study, is a 10-session developmentally-sensitive adaptation of CAMS for children ages 5 - 11 years old.
15840533|NCT04119622|Drug|Toripalimab|toripalimab 240 mg d1; q3w, up to two cycles.
15840534|NCT04119622|Drug|oxaliplatin|oxaliplatin 130 mg/m2 QD, d1,q3w, up to two cycles
15840535|NCT04119622|Drug|capecitabine|apecitabine 1000 mg/m2 BID, d1-d14 ,q3w, up to two cycles
15840536|NCT04119596|Diagnostic Test|16S rRNA gene sequencing|Taking a stool sample for gut microbiome DNA sequencing
15840537|NCT04119596|Genetic|DNA-microarray genotyping|Taking a saliva sample for genotyping
15840538|NCT04119583|Device|U-shape Automatic Electric Toothbrush|The U-shape Automatic Electric Toothbrush will be applied for 30-45 seconds on the teeth of both arches without the use of toothpaste.
15840539|NCT04119583|Other|Usual home toothbrushing procedure|Usual home toothbrushing procedure either with manual or electric toothbrush without the use of toothpaste.
15840540|NCT04119583|Other|Conventional Electric Toothbrush|The Conventional Electric Toothbrush will be applied for 2 minutes on the teeth of both arches without the use of toothpaste.
15840541|NCT04119570|Behavioral|CKD Report Card|The CKD Report Card is a handout based on a NKDEP Educational Sheet that includes basic information about kidney disease and spaces where patient can record information about their own kidney disease
15840542|NCT04119557|Drug|LY3471851|Administered SC
15840543|NCT04119557|Drug|Placebo|Administered SC
15840544|NCT04119544|Other|Conventional rehabilitation|upper limb rehabilitation involving submaximal passive amplitude stretching movements, inhibition postures, active efforts assisted of varying difficulty, target approach exercises with or without elbow support and gripping tasks, adapted to the upper limb's paresis abilities. The patient will be encouraged to gradually dispense with the assistance provided by the therapist or any technical assistance (suspension...) and thus to carry out the exercises in free active as soon as possible.
15840545|NCT04119544|Device|Intensive Visual Simulation|"First week: observation, mentalization and then attempt to perform the movements on the screen.
~Second and third weeks: production of analytical movements of wrist flexion/extension, pronation/supination, finger flexion/extension, thumb opposition.
~From the 4th week until the end: depending on the patient's motor capacities, continuation of the work of the previous 2 weeks or introduction of more functional work with object manipulation, gripping work.
~Conventional rehabilitation upper limb rehabilitation involving submaximal passive amplitude stretching movements, inhibition postures, active efforts assisted of varying difficulty, target approach exercises with or without elbow support and gripping tasks, adapted to the upper limb's paresis abilities. The patient will be encouraged to gradually dispense with the assistance provided by the therapist or any technical assistance (suspension...) and thus to carry out the exercises in free active as soon as possible."
15840546|NCT04119518|Device|CSEM Pulse Watch|Comparison of CSEM Pulse Watch with a gold standard oscillometric device Spacelabs OnTrak Ambulatory Blood Pressure monitor.
15840599|NCT04119037|Procedure|Cordotomy|Undergo cordotomy
15840600|NCT04119037|Drug|Morphine|Given via injection
15840601|NCT04119037|Other|Questionnaire Administration|Ancillary studies
15840602|NCT04119037|Procedure|Sham Intervention|Undergo fake cordotomy
15840603|NCT04119024|Drug|Cyclophosphamide|Given IV
15840547|NCT04119492|Behavioral|CO-OP Treatment Group|"Cognitive Orientation to Occupational Performance (CO-OP) is a cognitive approach to solving functional motor problems (Polatajko et al., 2001). Therapists teach children a global problem-solving strategy (Goal-Plan-Do-Check) as means to develop specific strategies for overcoming motor problems; the strategies are determined after a dynamic performance analysis by the therapist to determine where the breakdown is in performing the task. Occupational therapists trained in CO-OP will see children for one hour, once weekly for 10 weeks. Parents or caregivers will be encouraged to attend treat¬ment sessions so therapists can instruct them how to facilitate strategy use between treatment sessions. Children will select 3 functional motor goals to be addressed during treatment."
15840548|NCT04119466|Behavioral|Stabilizing training|The training will include the activation of the lumbar multifidus muscle (m. multifudus) and the transverse abdominal muscle (m. transversus abdominis). The performance of the individual stages of the training will be based on Richardson's methodology. One session will comprise 4 sets in which the patient will be asked to do pelvic tilts (draw-in) with simultaneous full exhalation, thus activating the aforementioned muscle groups in different positions: a) prone b) supine with lower extremities flexed c) quadruped d) standing back to the wall. The subjects will perform 3 series consisting of 10 repeats, each of which will last ca. 10 seconds.
15840549|NCT04119453|Drug|Rivoceranib|Rivoceranib will be supplied as 100 mg and 200 mg film-coated tablets for oral (PO) administration
15840550|NCT04119440|Biological|MVA-MERS-S_DF1 - Low Dose|Administrations of the low dose via the intramuscular route
15840551|NCT04119440|Biological|MVA-MERS-S_DF1 - High Dose|Administrations of the high dose via the intramuscular route
15840552|NCT04119440|Other|Placebo|Administrations of placebo via the intramuscular route
15840553|NCT04119427|Device|ultrasonic therapeutic apparatus 1|After installing the disposable treatment head coat, the transplanted kidney was treated with an ultrasonic therapeutic apparatus; after the treatment, the disposable treatment head coat was removed. Patients were treated twice a week for 6 weeks.
15840554|NCT04119427|Device|ultrasonic therapeutic apparatus 2|The placebo was treated with an ultrasound therapy device and used in the same manner as the test group.
15840555|NCT04119414|Behavioral|Spear and Shield (S&S) Program|The S&S Program is a comprehensive sexual risk reduction intervention consisting of 4 weekly 90-minute manualized group sessions conducted by a trained Community Health Center (CHC) facilitator.
15840556|NCT04119414|Behavioral|Like Father Like Son (LFLS) Program|The LFLS Program is a private 2 90-minute session conducted by a trained CHC facilitator. The sessions will be focused on exploring issues relevant to parental decision making related to voluntary medical male circumcision (VMMC) and early infant male circumcision (EIMC). Session 1 will be conducted antenatal and Session 2 will be immediately post-partum.
15840557|NCT04119401|Procedure|doppler-guided hemorrhoidal artery ligation|"Ligation: a lubricating gel is applied to the tip of the Transanal Hemorrhoidal Dearterialization device and, with the patient in the lithotomy position, the proctoscope is introduced into the anal canal. The terminal branches of the superior rectal artery are detected by the doppler signal 2-3 cm above the dentate line. The tip of the instrument is gently tilted and the arteries are ligated with a Z-shaped stitch using 2:0 braided polyglycolic acid suture inserted using a special needle-holder through an aperture in the operating proctoscope.
~Mucopexy: after the haemorrhoid artery ligation, the suture is continued with three to five sutures applied 5 mm apart, making sure that the last is at least 5 mm above the dentate line. The suture is then tied to create a hemorrhoidopexy. The procedure is repeated after all detected artery ligations."
15840558|NCT04119401|Procedure|Finger-guided hemorrhoidal artery ligation|"Ligation: the exact placement of all terminal branches of the superior rectal artery are found by intraoperative palpation at anal clock 2-3cm above the anorectal junction. Then arteries are ligated with Z-shaped suture using 2:0 braided polyglycolic suture.
~Mucopexy is then performed in the same technique as in comparative group"
15840559|NCT04119388|Other|Adapted sports practices|Adapted sports practices for 30 minutes twice a week
15840560|NCT04119375|Behavioral|Keheala Mobile Health Platform and Behavioral Interventions|"Keheala is a mobile health company that delivers powerful behavior change interventions from the social sciences across basic feature phones or smartphones to address the nonmedical drivers of disease, which exist away from health facilities.
~The intervention includes automated reminders, remote self-verification of doses, accessible TB information and individualized follow-up."
15840561|NCT04119375|Behavioral|Social and Behavior Change Communication (SBCC)|Automated reminders, remote self-verification of doses and accessible TB information. All interactions are behaviorally-informed but do not include regular adherence support/follow-up from study team members as the Keheala intervention does.
15840562|NCT04119375|Behavioral|SMS Reminder|Patients receive a single daily SMS message to take their medication.
15840563|NCT04119375|Other|Standard of Care|The standard-of-care protocol in Kenya includes diagnosis, the provision of medications - typically administered for a 1-2 week period at which point patients are expected to return to the clinical site - periodic on-the-ground follow-up by community health volunteers (CHVs)(at the discretion of local clinicians and CHVs) and nutritional support, as is sometimes provided.
15840564|NCT04119362|Other|Quality of live questionnaires|EORTC-Q30 questionnaire, additonal questionnaire on worries about quality of life impairments and on physical condition every 8 weeks. No additional visits will be carried out for questionnaires. Questionnaires will be handed out to patients during routine visits.
15840565|NCT04119362|Other|Optional translational project|Collection of archival tumor material for future translational projects. No biopsy will be performed in the context of this registry. Only tumor samples obtained in the context of standard of care and after explicit informed context will be used.
15840566|NCT04119349|Behavioral|Extra counseling|Participants will be given an extra 15-minute prenatal counseling before their first-trimester scan. The extra counseling, which is the intervention in the experimental group, consists of an explanation of all screening techniques for chromosomal abnormalities, including the first trimester combined test, cfDNA testing, invasive testing, and no screening at all.
15840567|NCT04119336|Drug|Nivolumab|Given intravenously once per cycle
15840568|NCT04119336|Drug|Ixazomib|Given orally on days 1, 8, 15.
15840569|NCT04119336|Drug|Dexamethasone|Given orally on days 1, 8, 15, 22
15840570|NCT04119336|Drug|Cyclophosphamide|Given intravenously on days 1, 8, 15.
15840604|NCT04119024|Drug|Fludarabine Phosphate|Given IV
15840571|NCT04119310|Other|Lumbar-thrust mobilization|The intervention group will receive passive spinal rotational grade V thrust-mobilization, based on Maitland's approach. The intervention will be performed with the subject in right sidelying and left sidelying. The operator's palpating hand is placed over the L2-3 intervertebral space, and the other hand bends both legs of the participant up to the range at which the L2-3 midposition is found. The participant is then asked to straighten the lower leg and hook the upper leg over it with the upper leg's knee positioned over the side of the plinth. While the lower component is kept still, the participant's trunk is rotated until the hip starts to lift off from the plinth. The bottom hand and uppermost hand rest under a pillow and the chest wall, respectively. With the starting position settled, the operator stands behind the participant, takes up the slack within the spine and then provides a grade V thrust- mobilization while stabilizing the uppermost shoulder.
15840572|NCT04119310|Other|Sham thrust-mobilization|Subjects are positioned in right sidelying. The experimenter holds both knees with one arm while placing their opposite hand on the participant's lumbar spine. The experimenter performs 1 min of ﬂexion and extension passive range of motion without reaching physiological end range in either direction of movement. This is repeated with the subject in left sidelying.
15840573|NCT04119297|Other|Routine care|"Routine care was applied to the periorbital area by clinical nurses.
~Periorbital edema, upper and lower eyelid ecchymosis of the patients were evaluated on the 3rd and 9th hours after craniotomy, and on the 1st, 2nd and 3rd days (twice daily) using the Kara & Gokalan's Scale"
15840574|NCT04119297|Other|Cold gel pack|"Cold application was applied to the periorbital area for 20 minutes per hour beginning 3rd hour following craniotomy, except from 10pm-7 am, and for three days using gel pack cooled to -14ºC.
~Periorbital edema, upper and lower eyelid ecchymosis of the patients were evaluated on the 3rd and 9th hours after craniotomy, and on the 1st, 2nd and 3rd days (twice daily) using the Kara & Gokalan's Scale"
15840575|NCT04119297|Drug|Heparinoids Topical Cream|"Heparinoid cream was applied to the periorbital area once at 3rd and 9th hours following craniotomy, and 4 times daily in the following 3 days.
~Periorbital edema, upper and lower eyelid ecchymosis of the patients were evaluated on the 3rd and 9th hours after craniotomy, and on the 1st, 2nd and 3rd days (twice daily) using the Kara & Gokalan's Scale"
15840576|NCT04119284|Device|Anterior body tether (ABT)|To insert the ABT in patients to correct AIS.
15840577|NCT04119271|Other|Breathe Easy at Home Kit Products|HEPA filtered upright vacuum cleaner, HEPA-filtered Air Purifier, Hypoallergenic latex free mattress cover, box spring cover, and two pillow covers, Healthier alternative to most household cleaners, Non- toxic glue type pest control devices for rodent control and a combination of safe products to locate and kill roaches.
15840578|NCT04119258|Behavioral|Cognitive-behavioral therapy|Cognitive-behavioral therapy including both behavioral and cognitive interventions.
15840579|NCT04119245|Device|I-gel supraglottic airway device|After induction of general anesthesia, we will measure the Oropharyngeal leak airway pressure during controlled ventilation in supine and in positions after insertion of I-gel.
15840580|NCT04119232|Behavioral|Social incentives-based program|Individual participants will use a wearable device to monitor daily step counts, set a step goal, and receive automated daily feedback on step goal attainment. Participants will be placed on a team of 3 randomly assigned participants and receive the social incentives intervention.
15840581|NCT04119219|Procedure|Intravitreal injection|Intravitreal injection to the regimen pro re nata.
15840582|NCT04119193|Device|Novel smartphone application for blood pressure measurement|Continuous blood pressure measurements will be compared between the new application and the reference method (invasive radial arterial line) during 5 minutes of recordings.
15840583|NCT04119180|Drug|Ketamine 50 MG/ML|Ketamine injectable solution in a concentration of 50.0 mg/mL via oral route; dose of 4.0 mg/kg maximum 100.0 mg
15840584|NCT04119180|Drug|Midazolam Hcl 2Mg/Ml Syrup|Midazolam oral solution in a concentration of 2.0 mg/mL via oral route; dose of 0.5 mg/kg, maximum 5.0 mg when associated with ketamine;
15840585|NCT04119180|Procedure|Protective stabilization|The legal guardian or accompanying person appointed by the legal guardian should sit in the dental chair with the child and contain leg and arm movements. A dental assistant keeps the child's head contained during care.
15840586|NCT04119154|Diagnostic Test|Contrast Microhalography (CEM)|Fine needle aspirates evaluated by CEM device
15840587|NCT04119141|Diagnostic Test|X ray imaging|"Acquisition:
~140 kVp,
~1/2 mAs/kg,
~Pitch: 1.35,
~Rotation time: 0.5 sec.
~Reconstruction:
~I70f filter, 3 iteration loops,
~Cutting thickness 1 mm/0.7 mm
~Fenestration: C -600/W 1600
~Field of view (Size, x & y coordinates) identical on both acquisitions."
15840588|NCT04119128|Device|Active Transcranial Direct Current Stimulation|Subjects will undergo 5 sessions of tDCS of up to 2mA, at 20 minutes per session, 1x per day. During active stimulation, the current will be active for the full 20 minutes.
15840589|NCT04119128|Device|Sham Transcranial Direct Current Stimulation|Subjects will undergo 5 sessions of tDCS, at 20 minutes per session, 1x per day. For sham tDCS, electrodes will be placed the same way as in the intervention group, for 20 minutes. However, the stimulator will deliver 2mA of current for only 30s. The current will not be active for the rest of the 20 minutes.
15840590|NCT04119115|Device|CT-V|CT-V is a newer computed tomography scan which is more comprehensive and tracks movement of the lungs.
15840591|NCT04119115|Other|Metabolites|Metabolites are compounds which can be measured in biospecimens and may indicate a disease or biological process.
15840592|NCT04119102|Drug|Duobrii|duobrii applied daily for 4 weeks followed by every other day for 4 weeks.
15840593|NCT04119089|Other|Gastric ultrasound|"A first gastric ultrasound will be performed in the supine and the right lateral (RLD) decubitus position, allowing a qualitative analysis of the gastric contents (empty, liquid, solid, solid-liquid). The antral area will also be measured in both positions. The volume of gastric fluid content will be calculated according to the following formula: volume (ml) = -7,8 + (0,035 x antral area in RLD (mm²)) + 0,127 x age (month).
~This examination will be immediately followed by the aspiration of gastric contents through the nasogastric tube used for enteral feeding, into 50-ml syringes, by a nurse blinded to the result of the first ultrasound examination. A second antral ultrasound examination will then be performed, by the same investigator blinded to the volume aspirated.
~The occurrence of regurgitation and / or vomiting occurring within the 12 hours before and after the examination will be recorded."
15840594|NCT04119076|Other|Classroom-based physical activity|
15840595|NCT04119076|Other|Control Group|
15840596|NCT04119063|Device|powered orthosis|Novel powered leg brace to provide assistance during walking.
15840605|NCT04119024|Biological|IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells|Given IV
15840606|NCT04119024|Drug|Recombinant Interleukin-2|Given SC
15840607|NCT04119011|Biological|Probiotic|(Lactobacillus acidophilus, lactobacillus casei, lactobacillus lactis) and Bifidobacterium (Bifidobacterium bifidum, bifidobacterium longum, bifidobacterium infantis) lactose, sugar, milk powder, oligosaccharides, ascorbic acid, citric acid, maltodextrin, and orange flavor
15840608|NCT04119011|Other|Placebo|lactose, sugar, milk powder, oligosaccharides, ascorbic acid, citric acid, maltodextrin, and orange flavor
15840609|NCT04118998|Behavioral|Abduction Loading|The intervention for the experimental group entails practicing reaching with abduction loading.
15840610|NCT04118998|Behavioral|Supported Reaching|The intervention for the active comparator entails practicing reaching while supported.
15840611|NCT04118985|Behavioral|Cognitive rehabilitation and health behavior change intervention|Cognitive rehabilitation and health behavior change intervention in a group-based program intervention compared to self-implementation of techniques without these interventions
15840612|NCT04118985|Behavioral|Self-implementation|Self-implementation of cognitive rehabilitation and health behavior change recommendations
15840613|NCT04118972|Behavioral|Mirror exposure and text prompt responses|Participants in the active interventions have three weekly mirror exposure sessions that are either guided with specific instructions as to where to look and how (only in functionality condition)
15840614|NCT04118946|Biological|platelet enriched plasma|PRP is prepared via a two-step centrifugation preparation of a blood sample, which is cured with an anticoagulant. Then either with be applied through urethral catheter in one arm or via submucos injection in anther one.
15840615|NCT04118933|Drug|JS001|JS001 240mg, Q3W
15840616|NCT04118920|Drug|Topic insulin (4 units)|N=6: 100 U/ml; 4 units of insulin per application; 40 microliters per drop
15840617|NCT04118920|Drug|Topic insulin (20 units)|N=6: 500 U/ml; 20 units of insulin per application; 40 microliters per drop
15840618|NCT04118907|Device|multiple sensory stimulation|The patients were recruited to record their medical history, and the hearing level, tinnitus indicators, vestibular function and tinnitus disability indicators were tested. Then the patients were randomly divided into six groups. They received the corresponding stimulation 20 minutes a day, 5 days a week for 3 weeks. After the last stimulation, the above tests were repeated immediately, one week later and three months later.
15840619|NCT04118894|Device|Foot and Ankle Devices|Wright devices used in foot and ankle procedures
15840620|NCT04118881|Other|Ear Acupuncture|Auricular Acupuncture (AA) is a micro-system of acupuncture and moxibustion initiated by Chinese and French doctors. All acupoints are distributed in the ear. In the treatment of perioperative patients, ear needle is far away from the surgical wound and its minimally invasive and tolerable position has obvious advantages over body needle.AA can regulate the function of corresponding organs at acupoints. The theoretical basis of TCM is holistic concept and syndrome differentiation and treatment.AA can prevent and treat perioperative nausea and vomiting. A number of randomized controlled trials and retrospective studies have confirmed that AA has obvious advantages in preventing nausea and vomiting in perioperative period compared with routine prevention, and its possible mechanism is ear-directed stimulation of the ear branch of vagus nerve, thereby enhancing gastrointestinal motility and accelerating gastric emptying.
15840621|NCT04118868|Combination Product|Pembrolizumab administered using the Sofusa® DoseConnect™|pembrolizumab will be administered intralymphatically using the Sofusa® DoseConnect™ device
15840622|NCT04118855|Drug|Toripalimab|3mg/kg, IV (in the vein) on on day 1 of 3-week, 6-week and 9-week for a total of 3 doses prior to partial nephrectomy or radical nephrectomy
15840623|NCT04118855|Drug|Axitinib|5 mg by mouth twice each day for 12 weeks prior to nephrectomy
15840624|NCT04118842|Drug|Savolitinib|Patients will receive a single dose on Study Day 1 and Study Day 20. Savolitinib will be administrated after a high fat, high calorie breakfast to reduce the risk of adverse events.
15840625|NCT04118842|Drug|Rifampicin|Patients will receive Rifampicin once daily on Study Day 15, 16, 17, 18, 19, 20 and 21. Rifampicin will be administered 1 hour before breakfast.
15840626|NCT04118829|Drug|Perampanel|"For group 1 the PER dose will be administered 2-14 hours prior to sample collection. They will be administered a single dose of PER (8 mg, 12 mg or 16 mg) followed by 4 mg/day for 14 days starting on postoperative day 1 (if continued prophylaxis with PER is needed).
~It is anticipated that patients in group 2 will have the daily dose of PER in these individuals will range from 4 - 12 mg/day."
15840627|NCT04118816|Diagnostic Test|Polysomnography|overnight polysomnography recording at least six hours
15840628|NCT04118816|Diagnostic Test|Multiple sleep latency test|daytime naps at least four to five naps to evaluate daytime sleepiness and narcolepsy
15840629|NCT04118816|Other|Continuous positive airway pressure|continuous positive airway pressure treatment for sleep-disordered breathing
15840630|NCT04118803|Device|ICD replacement or upgrade|Currently, it is common for patients to survive beyond their initial prophylactic ICD generator. It is unclear whether further benefit related to inappropriate shocks or ATP is derived from long-term device therapy, particularly if there has been a change in the patient's cardiovascular condition.
15840631|NCT04118790|Other|Clinical Assessment|"Medical history and details of the vascular incident will be collected from the patient and the medical journal. (Duration: 1hr)
~Neuropsychological measures collected using test measures and questionaries (duration approx 45-60 min)."
15840632|NCT04118790|Procedure|MRI scan|1. MRI scan session, which includes Structural, Quantitative, Functional and Diffusion MRI sequences. (maximum duration: 90 min).
15840633|NCT04118777|Drug|Ropivacaine|0.2 % Ropivacaine will be continuously administered intraperitoneally at a rate of 6 mL/hr
15840639|NCT04118725|Diagnostic Test|Pulmonary function test|Diaphragmatic electromyography with measurement of transdiaphragmatic pressure in cases of dyspnea and/or abnormal pulmonary function test (maximum inspiratory pressure and/or lying/seating low vital capacity ratio)
15840640|NCT04118699|Drug|Rifaximin oral tablet|Patients with chronic idiopathic intestinal pseudo-obstruction (CIIPO) or patients with chronic intestinal pseudo-obstruction (CIPO), secondary to systemic scleroderma, are administered investigational product (rifaximin) for 4 weeks
15840641|NCT04118699|Drug|Placebo oral tablet|Patients with chronic idiopathic intestinal pseudo-obstruction (CIIPO) or patients with chronic intestinal pseudo-obstruction (CIPO), secondary to systemic scleroderma, are administered placebo for 4 weeks
15840642|NCT04118686|Other|CoRe software training plus non-invasive brain stimulation techniques (anodical tDCS / rTMS)|CT program with Computerized cognitive training (CoRe) plus stimulation that modulates cortical activities by delivering strong magnetic pulses to the cortex through the scalp (rTMS) and weak electrical currents to the scalp to modulate neuronal transmembrane potential towards hyperpolarization or depolarization (tDCS).
15840643|NCT04118686|Other|CoRe software training plus sham non-invasive brain stimulation (sham tDCS/ sham rTMS)|CT program with Computerized cognitive training (CoRe) plus sham stimulation
15840644|NCT04118673|Behavioral|Lifestyle Prescription (LRx)|Standard care during consultations with the addition of a physical lifestyle prescription
15840645|NCT04118660|Other|Tissue Banking|Blood, tissue, and fluid collection
15840646|NCT04118647|Drug|Wu-Chu-Yu tang|Wu-Chu-Yu tang at a rate of 3.0 g three times per day for 28 days.
15840647|NCT04118621|Device|chest ultrasound|detection of postoperative pulmonary complications after cardiothoracic surgery
15840648|NCT04118608|Other|No intervention|No intervention
15840649|NCT04118595|Behavioral|Educational Video|Educational Video: Development of the original video was funded by the John A. Hartford Foundation and used a systematic approach that included a review of literature and current pain management guidelines and input from emergency physicians, geriatricians, and experts in pharmacology, physical therapy, and risk communication. The video offers information about the pharmacologic management of acute musculoskeletal pain (MSP) and recovery-promoting behaviors. Each video section is followed by a multiple-choice question to promote interaction and reinforce learning. The actress for the 13-minute video is a 56-year-old mixed-race woman who presents herself as a healthcare provider. The video script was developed for a grade level 5.5 and will be shown to the patient within 24 hours of the acute care visit. A link to the video is emailed or texted to the patient.
15840650|NCT04118595|Behavioral|Telecare|Telecare will be provided via a protocol-guided phone call from a nurse care manager 48-72 hours after discharge from the ED or orthopedic urgent care. The call is designed to support patient decision-making regarding analgesics and behaviors following the content presented in the video. Topics covered in the call will include discussion of goals and priorities the patient has for their pain management, current prescriptions and analgesic use (and adjustments if needed), non-pharmacologic methods of pain management, warnings about potential side effects, current healthcare utilization, and open-ended questions to address additional patient care needs. Conversations will be guided by a shared decision making framework in which the nurse suggests pain management options, discusses their pros and cons, and actively elicits feedback from the patient. The telecare call is designed to last 15 minutes.
15840651|NCT04118595|Behavioral|Correspondence with Primary Care Provider|Following the telecare conversation, a note will be sent directly to the patient's primary care provider using a secure email or an electronic message that includes: 1) The date, time, location and reason for the index visit; (2) Results of diagnostics studies; (3) Discharge prescriptions/ recommendations; (4) A summary of and link to the video, explaining the emphasis on patient knowledge and SDM; (5) A summary of the telecare conversation; and (6) Encouragement for follow-up. PCPs will be asked to confirm receipt of this message.
15840652|NCT04118582|Other|Body composition and resting metabolic rate analisys|
15840653|NCT04118569|Behavioral|Narrative Intervention|Research staff conducts an open-ended, audio-recorded interview with the patient about their illness and how this illness has affected their psycho-social-spiritual well-being. The investigators will use the interview transcription to create a meta-narrative, which is then uploaded to the electronic medical record and the patient's primary nurse is notified that it is available to read.
15840654|NCT04118556|Biological|Decidua Stroma Cells (DSC)|"Placenta-derived Decidua Stroma Cells. The product consists of a viable allogeneic DSCs frozen in 5% of human serum albumin (HSA) in sodium chloride (NaCl) 0.9% and 10% dimethylsulfoxide (DMSO), that is thawed and immediately diluted in 40 mL sodium chloride (NaCl) 0.9% prior to infusion. That will give a final concentration of 2.2% HSA and 2% DMSO.
~DSC will be infused when steroid-refractory acute GVHD after allogenic stem-cell transplantation has been diagnosed. Two doses, one week apart, will be given to all patients. Additional doses will be used depending on response."
15840655|NCT04118556|Drug|Best available Treatment (BAT)|The BAT in this study will freely be identified by the Investigator prior to patient randomization and may include treatments such as: extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), etanercept, vedolizumab, ruxolitinib or infliximab. Dose and frequency will depend on label (where approved) and institutional guidelines for various BAT.
15840656|NCT04118543|Other|Intervention Group|Each participant assigned to this intervention arm will start with a progressive cardiovascular warm-up for 10mins. The main exercise session will consist of resistance and cardiovascular based exercises targeting the whole body, which will last for 35-40mins. A cool-down period will follow lasting 5-10mins.
15840657|NCT04118543|Other|Sham-Exercise Group|Each participant assigned to this intervention arm will start with a warm-up for 10mins, which will be controlled in order to reduce any cardiovascular training effects. The sham-exercise sessions will consist of stretching, coordination and balance activities and very low-level cardiovascular activities that mimic the types of exercise done in the intervention group. This will last for 35-40mins, followed by a 5-10min cool-down.
15840658|NCT04118530|Other|HSCT Patients|Prospective, observational review of incidence of AF/AFL through Carelink remote monitoring and safety of implantation of device in this population of patients through review of standard of care follow up visits post HSCT implant
15840659|NCT04118517|Other|Using intrinsically labelled bean protein to assess bioavailability of amino acids in healthy adults|The intervention comprises a test meal of intrinsically deuterium labelled stewed common bean with rice. The meal is mixed with a reference protein (Universally labelled 13C-spirulina, 12 mg/kg) and 13C6-Phenylalanine (0.05mg/kg) which is divided into equal mini meals and fed hourly over 8 hours. Protein in the total meal provides 15% of the energy intake with the labelled bean contributing >50% of the protein.
15840660|NCT04118504|Device|Mobile application|Lifestyle intervention on through mobile application
15840661|NCT04118491|Device|hyperbaric oxygen and sham hyperbaric oxygen|see arm descriptions
15840662|NCT04118478|Behavioral|multi-component phased training program|The experimental group will develop a program that consists of three progressive phases with the predominance of one physical quality over the others. The first phase will have as its main objective to develop strength, through exercises with overload and in turn, it will be subdivided into 3 blocks of 3 weeks each: Neuromuscular adaptation, muscular power, muscular resistance. The second phase will have as its main objective to develop cardiorespiratory capacity through intermittent gait training and, in turn, will be subdivided into 3 blocks of 3 weeks each: Static gait, dynamic gait and dynamic gait with changes of direction. The last phase will have as its main objective to develop balance and flexibility, by strengthening the stabilizing muscles and range of motion. In turn, this phase will be subdivided into 3 blocks of 3 weeks each: Balance / static flexibility, balance / dynamic flexibility and balance / flexibility with a double task.
15840663|NCT04118465|Procedure|external cephalic version|external cephalic version
15840664|NCT04118452|Behavioral|Telephone-based early childhood developmental care coordination|The 211LA care coordinator will review developmental screening results and provide referral recommendations to the family and use 211LA's extensive resource directory and agency relationships to identify appropriate referrals. The 211LA care coordinator will provide a report to the clinical provider containing recommendations for follow-up and a care coordination plan. The report will be scanned into the EMR by clinic staff and be available for provider review. The 211LA care coordinator will also make all recommended referrals and will call the family monthly until 1) children begin receiving services, 2) families refuse services, or 3) children are deemed ineligible by service providers.
15840665|NCT04118439|Other|Motor Imaginery and Action Observation|A set of tasks done with the shoulder, first with an Action Observation perspective and then asked to perform this tasks with motor imaginery
15840666|NCT04118426|Radiation|Cognitive testing|"Patients will have their cognitive function tested by the use of standardized cognitive test and fill in questionnaires.
~Cognitive function will be assessed by standardized cognitive tests: Hopkins verbal learning test (HVLT), Trail Making Test part A and B (TMT A and TMT B), Pased Auditory Test (PASAT), Wechsler Adult Intelligence Scale coding and digit span (WAIS-IV), Controlled Oral Word Association Test (Cowat) and STROOP colour and word test (STROOP)
~Questionnaire include; Quality of life; EORTC QlQ-C30 (QlQ-C30), FACIT-Fatigue Scale (Version 4) (FACIT), Pittsburg Sleep Quality Index (PSQI), Hospital Anxiety and Depression Scale (HADS), Patient's Assessment of Own Functioning Inventory (PAOFI)."
15840667|NCT04118413|Other|erector spinae plane block|Erector espine plane block will be administrated bilaterally to this group at low thoracic level (Th11).
15840668|NCT04118400|Procedure|NIV-NAVA|NAVA mode during Non-invasive ventilation
15840669|NCT04118400|Procedure|Nasal CPAP or NIMV mode|Nasal CPAP or NIMV mode during Non-invasive ventilation
15840670|NCT04118387|Drug|Acetazolamide + supplemental oxygen + PAP therapy|Every participant will undergo measurement of the apneic threshold. The apneic threshold (AT) can be determined by inducing central apnea using non-invasive ventilation (NIV) or eliminating central apnea using supplemental CO2. The requisite change to induce central apnea is referred to as the CO2 reserve, which can be positive or negative. The central apnea index and the apneic threshold will be measured while participants receiving medication or oxygen (or both). In addition, participants will get PAP therapy during all the conditions.
15840671|NCT04118387|Drug|Zolpidem + PAP therapy|The central apnea index and the apneic threshold will be compared under two conditions: zolpidem or placebo. In addition, participants will get PAP therapy during both the conditions.
15840672|NCT04118387|Drug|Buspirone + PAP therapy|The central apnea index and the apneic threshold will be compared under two conditions: buspirone or placebo. In addition, participants will get PAP therapy during both the conditions.
15840673|NCT04118374|Other|Standard Carb Diet|Approximately 50% of caloric intake will come from carbohydrate consumption.
15840674|NCT04118374|Other|Low Carb Diet|Approximately 25% of caloric intake will come from carbohydrate consumption.
15840675|NCT04118361|Diagnostic Test|HINTS Test|"The HINTS test is a clinical test composed of 3 oculomotor examinations:
~Search for high-frequency vestibulo-ocular reflex during a passive head impulse test
~Highlighting of spontaneous nystagmus: it must be sought without, then with Frenzel glasses because they allow to temporarily interrupt the ocular fixation.
~Vertical divergence
~This test is performed at the patient's bedside in about 3 minutes. Presence of at least one of the three items of central locator value is sufficient to diagnose a central cause of VAS, including normal early brain imaging."
15840676|NCT04118361|Diagnostic Test|STANDING Algorithm|The STANDING algorithm consists of clinical elements that can be evaluated in about 10 minutes at the patient's bedside: two oculomotor examinations (Head Impulse Test and detection of a nystagmus), detection of ataxia and the practice of release maneuvers.
15840677|NCT04118348|Behavioral|Best Practice Alert|An Epic screen pops up for a provider during an eligible 9-11 year-old patient's visit. A prompt requires that the provider respond, either confirming the prescription of a lipid panel or opting out with an acknowledgment/reason for declining the test.
15840678|NCT04118348|Behavioral|Health Maintenance Topic|An Epic health maintenance topic appears for a provider during an eligible 9-11 year-old patient's visit. The HMT will be highlighted for enhanced visibility, until or unless action is taken.
15840679|NCT04118335|Other|Black Mulberry Syrup|The individuals in the intervention group gargled with 5 ml black mulberry syrup and waited average one minute and then swallow it.
15840712|NCT04118049|Other|BiopHreshTM vaginal probiotic supplement (Good Clean Love, Inc. Eugene, OR) and RestoreTM gel.|BiopHreshTM is a vaginal probiotic supplement that is offered over the counter and contains four different lactobacilli strains (L. crispatus, L. gasseri, L. jensenii, and L. rhamnosus). RestoreTM is a moisturizing personal lubricant that has been on the market for three years. Participants will use 1 probiotic capsule with RestoreTM gel nightly three times weekly.
15840680|NCT04118322|Other|aromatherapy (peppermint oil)|"The patients in the intervention group received routine medical treatment program and were asked to put one drop of peppermint oil upon lips following chemotherapy administration. Before peppermint oil application; the researcher theoretically and practically provided a training of 8-10 minutes about the use of peppermint oil and the patients were requested to apply this oil three times a day according to Oil Practice Guide (See Fig. 2) in the morning (09:00), at noon (15:00) and in the evening (21:00).
~Aromatherapy essential oil used was a mixture of English peppermint (Mentha piperita; 3%) and sweet almond oil (30 ml)"
15840681|NCT04118309|Behavioral|Exercise|
15840682|NCT04118309|Other|Placebo|
15840683|NCT04118296|Drug|Anti-Acne Preparations for Topical Use|Combination of anti acne cream that contain active substances such as Clindamycin 3%, Dexamethasone 0.05% and Tretinoin 0.05%
15840684|NCT04118283|Behavioral|Cognitive Behavioral Therapy for Chronic Pain|Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) will be conducted in accordance with the Cognitive Behavioral Therapy for Chronic Pain: Therapist Manual and the VA Evidence-Based Practice (EBP) roll-out training. CBT-CP consists of a 12-session protocol, including an initial assessment session (BL assessment; Session 1), 10 content-specific sessions (pain education, goal-setting, cognitive and behavioral skill building; Sessions 2-11), and a booster session scheduled approximately one month after the final CBT-CP session (Session 12). Participants randomized to the CBT-CP condition (n = 30) will complete one 60-minute individual session per week. Each CBT-CP session will be led by a trained study interventionist using a manualized curriculum, following a basic structure including review of previous session material, introduction of new information or skills, and discussion of how to implement learned material into a home action plan.
15840685|NCT04118283|Behavioral|Health and Wellness|Health & Wellness was developed by VISN 5 MIRECC investigators and consists of psychoeducation on topics related to physical and emotional wellbeing. Its structure is similar to CBT-CP (10 weekly individual 60-minute sessions, no booster session). Each Health & Wellness session will be led by a trained interventionist using a manualized curriculum that includes review of previous session material, introduction of new information, and discussion of a range of health-related topics (physical activity/exercise, nutrition/healthy eating, managing medications and side effects, and addictive behaviors (e.g., substance use, gambling, eating) that do not include pain. Typical sessions include discussion of the impact of the topic on overall health and well-being, identifying benefits and challenges to improving or maintaining health in that area, and strategies to address challenges in that area.
15840686|NCT04118270|Device|Afib 2gether TM Mobile Application|The Afib 2gether mobile app determines a patient's stroke risk through a series of questions that the patient will answer in the app.
15840687|NCT04118257|Dietary Supplement|Sugary beverage: Fruit juice|Participants consumed 100% fruit juice (~710mL) daily for three weeks, along with their habitual diets.
15840688|NCT04118257|Dietary Supplement|Sugary beverage: Soda|Participants consumed soda (~710mL) daily for three weeks, along with their habitual diets.
15840689|NCT04118257|Dietary Supplement|Control: Water|Participants consumed water (~710mL) daily for three weeks, along with their habitual diets.
15840690|NCT04118244|Diagnostic Test|lung recruitment maneuver|The ventilator was switched to pressure control ventilation, inspiratory time was increased to 50%, the peak inspiratory pressure gradient (above PEEP) was set at 15cm H2O, and PEEP was progressively increased to obtain a stepwise increase of peak inspiratory to 20, 25, and 30 cm H2O every three breaths. The final recruiting pressure of 30 cm H2O was applied for six breaths.
15840691|NCT04118231|Other|Dry needling|Group 1: Dry needling Group 2: static stretching Group 3: IASTM
15840692|NCT04118218|Other|Rhizolysis pain analysis|"Definition of the subgroup of good clinical outcome after rhizolysis (called effective rhizolysis) by lumbar VAS or lower extremity pain VAS or Oswestry index decreased at 6 weeks after rhizolysis.
~The efficiency criterion based on the decrease in the dolorimeter or the Oswestry index corresponds to a decrease of at least 50% [1, 2, 3, 4]."
15840693|NCT04118192|Procedure|Tumour bed core biopsy|Collection of up to 8 core biopsies across 4 zones of the whole tumour bed to detect residual cancer post neo-adjuvant treatment
15840694|NCT04118179|Other|Blood sample collection|A blood sample (1 tube) will be collected for the analysis of the CR signature.
15840695|NCT04118166|Drug|Ipilimumab|Ipilimumab 1 mg/kg, injection
15840696|NCT04118166|Procedure|Cryoablation|Cryoablation of the tumors occur between investigational agent treatment Cycles 1 and 2, and will be performed according to standard procedures
15840697|NCT04118166|Drug|Nivolumab|Nivolumab 3 mg/kg, injection
15840698|NCT04118153|Drug|Abatacept|Abatacept will be administered by subcutaneous injections weekly for 3 months. Dosing is according to body weight at screening visit and will be administered as follows: up to 25 kg receive 50 mg (0.4 mL); 25 to <50 kg receive 87.5 mg (0.7 mL), and > 50 kg receive 125 mg (1.0 mL) per dose.
15840699|NCT04118140|Other|Somatic Acupressure|Daily self-acupressure (details of the intervention protocol will be determined by three systematic reviews and the systematic reviews are in progress) plus usual care (an education booklet)
15840700|NCT04118140|Other|Sham acupressure|Same dose as the true acupressure group but on the sham acupoints plus usual care (an education booklet)
15840701|NCT04118140|Other|Usual care|Usual care only (an education booklet)
15840702|NCT04118127|Drug|2mg conventional tablet, once-weekly tablets|In each cohort, subjects will receive a brexpiprazole 2 mg conventional tablet on Day 1of Period 1, the QW formulation on Day 1 of Period 2 and 3, as single and multiple dose in a fasted state.
15840703|NCT04118114|Drug|PRL3-zumab|IV administration every 2 weeks
15840704|NCT04118101|Drug|ESPB block|A total of 25 ml bupivacaine 0.5% will be injected into the ESP.
15840705|NCT04118101|Other|control|no ESPB will be given.
15840707|NCT04118075|Drug|PT-CY-FK +/-ATG|GVHD prophylaxis: PT-CY followed by tacrolimus for all patients. low-dose ATG for patients with unrelated or haplo-identical transplantation.
15840708|NCT04118062|Behavioral|Questionnaires|Questionnaires
15840709|NCT04118062|Behavioral|Semi-structured individual interviews|Semi-structured individual interviews
15840710|NCT04118062|Other|Focus Group|Focus Group
15840711|NCT04118062|Other|DELPHI Consensus Method|DELPHI Consensus Method
15840713|NCT04118049|Other|Standard Care|Standard care arm is standard care for pessary use. Pessary maintenance will be performed standardly by their provider.
15840716|NCT04118023|Diagnostic Test|7 Tesla Magnetic Resonance Imaging Test|MAGNETOM Terra - 7T MRI Scanner by Siemens Healthineers. Each patient enrolled will undergo the study imaging test prior to planned diagnostic knee arthroscopy.
15840717|NCT04118010|Drug|Vitamin D3|High-dose vitamin D3 50,000 IU /week for 12 weeks
15840718|NCT04118010|Drug|Placebo vitamin D3|Matching to Vitamin D3 placebo capsules for 12 weeks
15840719|NCT04118010|Drug|Inulin|Chicory-derived prebiotic inulin 12 g/day for 12 weeks
15840720|NCT04118010|Drug|Placebo Inulin|Corn-derived maltodextrin 12g/day as the prebiotic placebo for 12 weeks
15840721|NCT04117971|Other|Questionnaire|The study will involve structured questionnaire asking questions about knowledge, attitude, and practice of child abuse diagnosis and reporting among dentists.
15840723|NCT04117945|Biological|Cetuximab|Given IV
15840724|NCT04117945|Drug|Irinotecan|Given IV
15840725|NCT04117945|Biological|Panitumumab|Given IV
15840726|NCT04117945|Drug|Regorafenib|Given PO
15840727|NCT04117932|Drug|Ustekinumab|Ustekinumab (90 mg subcutaneously at weeks 0, 4, 16), in association with topical superpotent corticosteroid (10-30 g per day during the first 4 weeks, then every other day during 4 weeks).
15840728|NCT04117919|Drug|paper mulberry leaf|Topical steroids+paper mulberry leaf The botanical origin of paper mulberry leaf is Broussonetia papyrifera (L.) Vent.
15840729|NCT04117919|Drug|Triamcinolone (Encort-A) 0.1%15g/Tube|only Topical steroids
15840730|NCT04117906|Behavioral|STAGE training for anxiety|STAGE is a brief, online, self-help course designed to target anxiety through providing training in perspective broadening and self-distancing.
15840731|NCT04117893|Drug|Duloxetine|Participants will start on duloxetine 30 mg per day for one week and then titrated up to duloxetine 60mg per day for 23 weeks.
15840732|NCT04117893|Drug|intra-articular injection of corticosteroid and hyaluronic acid|Participants will receive a 3.5 ml intra-articular injection of 30mg of hyaluronic acid plus 10mg of triamcinolone acetonide.
15840733|NCT04117880|Drug|Ataluren|Oral
15840734|NCT04117867|Behavioral|Patiens with intraoperative hypotension|In this study, we will use four previously defined thresholds for intraoperative hypotension: two absolute thresholds (MAP less than 50 mmHg and MAP less than 60 mmHg) and two relative thresholds to the baseline MAP (a decrease of 30% or more and a decrease of 40% or more). A definition of baseline value most frequently reported was the arterial blood pressure before the induction of anesthesia. Therefore, the baseline MAP used in calculating the relative thresholds is defined as the mean MAP of all available blood pressure measurements before induction of anesthesia in the operating room.
15840735|NCT04117841|Other|Observational|All groups will undergo observational data collection. No interventions will be made to patient care.
15840736|NCT04117828|Dietary Supplement|Dates|Phoenix dactylifera, commonly known as date or date palm is a flowering plant species in the palm family, Arecaceae. Dates are the fruit of the date palm tree, which is grown in many tropical regions of the world. Dates provide a wide range of essential nutrients, and has certain protective effects on health of individuals.
15840737|NCT04117815|Device|Paxman Scalp Cooling System|"All patients who accomplish inclusion criteria and do not exhibit any contraindication undergo scalp cooling with the following conditions:
~Minimum 30 minutes pre-infusion cooling
~Cooling for the duration of chemotherapy infusion
~Minimum 90 minutes post-infusion cooling Scalp cooling is performed within the study group at each CT session."
15840738|NCT04117815|Other|Alopecia Assessments|"Patients (study group and reference group) will be assessed at the following time Points:
~Baseline
~at the half-way Point of the cyles
~at the last CT cycle
~3 months after completion of Treatment
~6-9 months after treatment completion
~The assesments include the following
~Photographs of the head, which are evaluated using the CTCAEv4.0
~Questionnaire including the NCI- PRO-CTCAE-ITEMS, EORTC QLQ-C30, EORTC QLQ-B23, Body Image Scale, PRO-CTACAEs and Hairdex questionnaire"
15840739|NCT04117802|Other|Maple syrup|Substitution of refined sugar by an equivalent quantity of maple syrup (5% of daily energy intake) in the participant diet. A dietitian will help study subjects to target added sugar sources in their usual diet and suggest ways to substitute it with maple syrup.
15840740|NCT04117802|Other|Placebo|Substitution of refined sugar by an equivalent quantity of maple-flavored sucrose syrup (5% of daily energy intake) in the participant diet. A dietitian will help study subjects to target added sugar sources in their usual diet and suggest ways to substitute it with the placebo (sucrose syrup).
15840741|NCT04117789|Behavioral|Therapist-guided internet-delivered cognitive behavior therapy for depression in adolescents|Participants will be assigned to a 10 weeks internet-delivered cognitive behavior therapy program with therapist support via an internet platform.
15840742|NCT04117789|Behavioral|Self-guided internet-delivered cognitive behavior therapy for depression in adolescents|Participants will be assigned to a 10 weeks internet-delivered cognitive behavior therapy program without therapist support via an internet platform.
15840743|NCT04117789|Other|Treatment as usual|Participants randomized to TAU, will be referred to the local CAMH's or primary care unit for children and youths and will be free to receive any treatment, either psychosocial, medical or the combination of both.
15840744|NCT04117776|Other|Skin microbiological sampling (wash with 2% Chlorhexidine Gluconate)|3 microbiological samples, per application of agar on skin, after 24h of a first wash with 2% Chlorhexidine Gluconate : 1h before the second wash with the same washing product and then 1 to 2 h after, and 20 to 23h after this second wash.
15840745|NCT04117776|Other|Skin microbiological sampling (wash with mild soap)|3 microbiological samples, per application of agar on skin, after 24h of a first wash with mild soap : 1h before the second wash with the same washing product and then 1 to 2 h after, and 20 to 23h after this second wash.
15840746|NCT04117763|Drug|Empagliflozin 25 MG|Empagliflozin once daily, for three months
15840747|NCT04117750|Dietary Supplement|cholecalciferol (vit D3)|42,000 IU oral vitamin D per week and 500 mg calcium carbonate
15840748|NCT04117737|Other|Virtual reality combined with anti-gravity treadmill|"The system is composed of three major parts: the treadmill, the antigravity system and the virtual reality system.
~The treadmill is the base of the device. It is a rounded and concave structure that permits to walk in all direction. For simulate anti-gravity, a harness and pulley system allow to regulate the weight. Finally, the virtual reality system enables participants to simulate an experience of daily life."
15840749|NCT04117724|Other|Survey|Patients will be asked to complete a 4 question survey assessing adherence. Follow up via patient's preferred method of contact will be conducted after the patient's intended antibiotic completion date and covariates for antibiotic regimens will be recorded including antibiotic type, number of doses, antibiotic duration, reason for non-adherence, pills remaining, and number of other medications.
15840750|NCT04117711|Drug|AT-007|AT-007 will be administered once daily before breakfast. Up to 4 different dose cohorts in part A; up to 4 dose cohorts in part B, up to 2 dose cohorts for part C, and up to 3 dose cohorts for part D will be enrolled in the study. The starting dose in Part A will be 0.5 mg/kg as a single dose. Subsequent doses in Part A and all doses in Parts B, C, and D will be based on the results of previous cohorts and/or previous parts of the study. Part B will start after all subjects in Part A have completed the study. Cohort C1 will be conducted simultaneously with Cohort B3 and using the same dose as Cohort B2. The dose for Cohort D1 will not be higher than the dose for Cohort B2. The second and third cohorts in Part D (D2 and D3) will not start until after all subjects in Cohorts B3 and B4, respectively, have completed the study and the dose levels will not be higher than those for Cohorts B3 and B4, respectively.
15840751|NCT04117711|Drug|Placebo|Matching placebo capsules will be administered once in the morning before breakfast
15840752|NCT04117698|Drug|Antitubercular treatment (RIFATER ©)|"Treatment of ocular inflammation by antitubercular treatment  add-on of local corticosteroid therapy comprising:
~RIFATER © (Isoniazid + Rifampicin + Pyrazinamide) + Ethambutol (13.5-20 mg / kg / day) for 2 months then RIFINAH © (Isoniazid + Rifampicin) for 4 months
~associated with a treatment similar to the control group."
15840753|NCT04117698|Drug|Ethambutol|Ethambutol
15840754|NCT04117698|Drug|RIFINAH ©|RIFINAH ©
15840755|NCT04117685|Other|Observational|All groups will undergo observational data collection. No interventions will be made to patient care.
15840756|NCT04117672|Dietary Supplement|Salovum|Active egg yolk powder
15840757|NCT04117672|Dietary Supplement|Placebo egg yolk powder|Normal egg yolk powder
15840758|NCT04117659|Other|withdrawal of oral medication (phosphodiesterase-5 inhibitor) in pretreated patients|discontinuation of the oral medication with a phosphodiesterase-5 inhibitor
15840759|NCT04117646|Other|Sinus and nasal quality of life survey questionnaire (SN-5)|Subjects respond to the translated questionnaire twice at 15 days apart.
15840760|NCT04117633|Device|Laparoscopy|Laparoscopic Procedures for Rectopexy
15840761|NCT04117620|Other|Pediatric Vestibular Symptom Questionnaire|Subjects respond to the translated questionnaire twice with 15 days interval
15840762|NCT04117607|Other|Placebo|5% Dextrose Injection, USP, a sterile, nonpyrogenic solution of dextrose in water for injection. The solution has the osmolarity of 252 mOsmol/L, which is slightly hypotonic. This solution contains no bacteriostat, antimicrobial agent or added buffer.
15840763|NCT04117607|Drug|Rezafungin|Rezafungin, 100 mg/mL, is a sterile liquid product supplied in single-dose vials containing 1.0 mL of extractable volume. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredient is mannitol.
15840764|NCT04117607|Drug|Rezafungin|Rezafungin, 200 mg/vial, is a sterile product supplied as a white to pale yellow lyophilized powder in single-dose glass vials for reconstitution with Sterile Water for Injection, United States Pharmacopeia (USP). The reconstituted product is diluted in 0.9% Sodium Chloride Injection, USP for IV infusion. The active pharmaceutical ingredient is rezafungin acetate, a water-soluble amorphous acetate salt. The inactive ingredients include excipients of mannitol, polysorbate 80, and histidine.
15840765|NCT04117594|Diagnostic Test|WB-MRI|Whole body MRI with diffusion-weighted imaging (DWI)
15840766|NCT04117581|Dietary Supplement|Vitamin D3|5000 IU (125 μg) vitamin D3 capsules daily over 12 weeks (84 days)
15840767|NCT04117581|Other|Placebo|Inert filler capsules daily over 12 weeks (84 days)
15840768|NCT04117568|Other|Blood sampling|Blood sampling at 3-5 occasions per admission
15840769|NCT04117555|Diagnostic Test|Pupil response to light stimuli|Objective and accurate measurement of pupillary responses to light stimuli
15840770|NCT04117542|Other|Observational|Observational data will be obtained through participant self-response, parental response, cognitive performance, and neural imaging.
15840771|NCT04117529|Other|Blood sample|Collection of 2 blood sample : The first one at the inclusion in the study, the second one between 6 months and 9 months after the inclusion. The sample consists of 2 tubes of EthyleneDiamineTetraAcetic (EDTA) of 7 mL.
15840772|NCT04117516|Procedure|Open surgery|"Open carpal tunnel release will be performed, in the theatre, with tourniquet, under local anesthesia and sedation, through a short longitudinal volar classical approach of the hand, that allows to visualize the complete division of the ligament."
15840773|NCT04117516|Procedure|Percutaneous surgery|Percutaneous carpal tunnel release will be performed, ambulatory, with a percutaneous scalpel, through a short transverse volar approach, 1-2cm proximal to the wrist, under Wide Awake Local Anesthesia with No Tourniquet.
15840774|NCT04117490|Other|Epiitalis|Two capsules twice daily 30 mins before meals (breakfast & dinner).
15840775|NCT04117490|Other|Placebo|Two capsules twice daily 30 mins before meals (breakfast & dinner).
15840776|NCT04117477|Drug|Xylitol|Xylitol dental wipes
15840777|NCT04117477|Other|Placebo|Placebo dental wipes
15840778|NCT04117464|Behavioral|Behavioral activation therapy|Behavioral activation therapy administered on a group basis (maximum 6 people) over 8 weekly sessions of 90 minutes.
15840779|NCT04117464|Behavioral|Acceptance and Commitment Therapy|Acceptance and Commitment Therapy administered on a group basis (maximum 6 people) over 8 weekly sessions of 90 minutes.
15840780|NCT04117464|Behavioral|Cognitive-Behavioral Therapy|Cognitive-Behavioral Therapy on a group basis (maximum 6 people) over 8 weekly sessions of 90 minutes.
15840781|NCT04117464|Other|Wait List Group|No psychological intervention
15840782|NCT04117451|Other|Propolis|Investigating the impact of propolis mouthwash on oral and cardiovascular health
15840783|NCT04117438|Other|no intervention|There is no intervention. We are just asking breast cancer patients what their food story is.
15840784|NCT04117425|Biological|biological collection|"Blood collection at each trimester of pregnancy, delivery and post partum visit or at medical interruption.
~Collection of saliva at each trimester of pregnancy and post partum visit. Collection of cord blood and amniotic fluid at delivery or at medical interruption."
15840785|NCT04117412|Other|Exercise|Same participants will undergo different one bout of exercise protocols
15840786|NCT04117399|Other|Pulmonary rehabilitation|The experimental group receives inspiratory muscle training and aerobic exercise. The Active Comparator group received only aerobic exercise group received only aerobic exercise.
15840787|NCT04117386|Diagnostic Test|HPV genotyping assay using HPV GenoArray Diagnostic Kits (Hybribio Ltd., Sheung Wan, Hong Kong)|HPV genotyping assay using HPV GenoArray Diagnostic Kits (Hybribio Ltd., Sheung Wan, Hong Kong) for swab sample collected from pterygium and normal conjunctiva and also for urine collected in Colli-PeeTM device (Novosanis, Belgium)
15840788|NCT04117386|Diagnostic Test|Bio-Plex® 200 system (Bio- Rad, Hercules, CA)|Bioplex was use for measure cytokine IL-6, IL-18 and VEGF from tears collected from Schirmer strip
15840789|NCT04117360|Other|Orthognathic surgery and Orthodontics|This study is observational. All subjects identified to participate will be undergoing orthognathic jaw surgery and orthodontic treatment.
15840790|NCT04117347|Device|Light therapy A via the Re-Timer®|Subjects will conduct light treatment in the mornings at home.
15840791|NCT04117347|Device|Light therapy B via the Re-Timer®|Subjects will conduct light treatment in the mornings at home.
15840792|NCT04117347|Device|Light therapy C via the Re-Timer®|Subjects will conduct light treatment in the mornings at home.
15840793|NCT04117334|Other|Bracing|
15840794|NCT04117308|Procedure|Classic information|The team delivers to each patient a unique and standardized information brochure including a definition of fetal active movements, and the need to consult if the patient perceives less the movements of her fetus.
15840795|NCT04117308|Procedure|Information by detailed brochure on the fetal active movements account|Delayed single and standardized explanatory card on fetal movements (definition, interests of their follow-up, technique of movements on fetuses, table to fill during the follow-up noting the number of active movements physical feelings at 3 times of the day, managing the decrease in the number of active fetal movements).
15840796|NCT04117295|Device|Carmat Total Artificial Heart|Heart replacement therapy
15840797|NCT04117282|Other|gait training|training for improving the quality of gait through adjusting gait cycle phases time and improving the functional level and independence during gait
15840798|NCT04117269|Device|External shoe lift|Height compensation will be made with cork or EVA (polyurethane + Ethylene Vinyl Acetate) depending the characteristics of the shoe. It will be made by the same orthophaedic technician. The prescription of the heigh of the lift will be made with the patient in a barefoot standing position, a calibre will be used to mark the femoro-tibial joint in both lower limbs in order to rule out the asymmetry. After this, the patient will shod the offloading device in the ulcerated feet and their conventional footwear in the other foot (with the use of their own foot orthosis). 5 millimeters splints will be added under the non affected footwear until the previous mark in both limbs been balanced. The difference in the heigh between limbs will be assessed measuring all the splints used previously
15840799|NCT04117256|Device|Direct Current Stimulation|20 minutes of direct current stimulation using an intensity of 1.5mA and electrode size of 6x4cm
15840800|NCT04117256|Device|Sham DCS|20 minutes of sham stimulation. Subjects will be stimulated during the first 30 seconds. After that, a ramp down of 10 seconds and then the stimulator is turned-off.
15840801|NCT04117243|Drug|Misoprostol|patients will be given 400 microgram misoprostol (2 tablets - Cytotec, Pfizer, G.D. Searle LLC) sublingually immediately before starting skin incision (n=115)
15840802|NCT04117243|Drug|Tranexamic acid|patients will be given 1 gm (10 ml) TXA (Kapron, Amoun, Egypt) diluted in 20 ml of Glucose 5% (administered as intravenous infusion over 5 minutes, at least 15 minutes prior to skin incision) (n=115)
15840803|NCT04117243|Drug|Oxytocin|patients will receive an intravenous bolus of 5 IU oxytocin (Syntocinon, Novartis, Basel, Switzerland) and 20 IU oxytocin in 500 mL lactated Ringer's solution (infused at a rate of 125 mL/h) following the delivery of the baby (n=115)
15840804|NCT04117217|Diagnostic Test|Labs drawn|We will collect blood samples/biomarkers at the time of enrollment.
15840805|NCT04117204|Other|Fruits and Vegetables|Fruits and Vegetable delivery, once a week for 12 weeks.
15840806|NCT04117191|Dietary Supplement|Doctor's Best L-Tryptophan|2g tryptophan loading once
15840807|NCT04117178|Drug|Donepezil|Adjustment of treatment with donepezil according to serum level.
15840808|NCT04117178|Drug|Memantine|Adjustment of treatment with memantine according to serum level.
15840809|NCT04117178|Diagnostic Test|Measurement of serum level of anti-dementia drug|"Participants allocated to the intervention arm are requested to inform the sponsor of any side effects up to 2 months after prescription of the anti-dementia drug. If so, they will have their treatment adjusted according to the serum level. Participants in the intervention group not experiencing side effects will have their treatment adjusted after 6 months based upon serum levels of the drug in question.
~Participants allocated to the standard of care arm follow the usual routines of the dementia clinic but are requested to have the serum level of the prescribed drug and CYP2D6-genotype measured after 12 month."
15840810|NCT04117165|Diagnostic Test|Biotherapy Prescription with SinnoTest® software|The rheumatologist will use the SinnoTest® software to give the best biotherapy to the patient according to the results of the software.
15840811|NCT04117165|Drug|Patient Current Care|The rheumatologist will use the french guidelines of rheumatoid arthritis to choose the more adapted biotherapy treatment to the patient.
15840812|NCT04117152|Other|Latent class mixed modeling|To identify CAV trajectories after heart transplantation using a contemporary unsupervised trajectory-based approach known as latent class mixed modeling
15840813|NCT04117139|Diagnostic Test|PET/MRI|A PET/MRI of the Head and Neck region is done for all patients included in the project.
15840814|NCT04117126|Behavioral|Prompted voiding|"Monitoring: This involves asking the incontinent individual, at regular intervals, if he or she needs to use the toilet. The care provider may look for behaviours that the client needs to be toileted (e.g., restlessness, agitation, disrobing), and take the client to the toilet at regular intervals specific to their schedule, rather than routinely every two hours.
~Prompting: This process includes prompting the person to use the toilet at regular intervals, and encourages the maintenance of bladder control between prompted voiding sessions.
~Praising: This important step is the positive reinforcement of dryness and appropriate toileting, and is the response from the care provider to the individual's success with maintaining bladder control."
15841148|NCT04114513|Dietary Supplement|Pectin|BANG & BONSOMER GROUP OY, white powder 5 weeks intervention
15840815|NCT04117100|Procedure|Polypectomy or myotomy|Advanced therapeutic endoscopy can replace surgery for treatment of benign and malign GI diseases and the aim of this registry-based study to improve quality related to advanced therapeutic endoscopy because the trial will provides a quantitative method to assess advanced therapeutic practise at the CHUM and may identify practices of low quality (possible intervention) or high quality (desired). Advanced therapeutic endoscopy procedures included for this registry-based study are EMR, ESD, Assessment of polypectomy quality for colorectal adenomas/polyps, Radio Frequency Ablation (RFA) and Argon Plasma Ablation (APC), and Per Oral endoscopic Myotomy (POEM).
15840816|NCT04117087|Drug|KRAS peptide vaccine|"KRAS peptide vaccine will be administered on days 1, 8, 15 and 22. Five boost vaccinations with will be administered at 8 week intervals (on weeks 13, 21, 29, 37, and 45).
~Drug: 1.8 mg KRAS peptide vaccine + 0.5mg Poly-ICLC"
15840817|NCT04117087|Drug|Nivolumab|"Nivolumab 3mg/kg will be administered as a 30 minute IV infusion (-10min/+15min) every 3 weeks for four doses. In the boost phase 480 mg flat dose will be administered every 4 weeks beginning C5D1.
~Drug: 3mg/kg IV, 480 mg IV"
15840818|NCT04117087|Drug|Ipilimumab|"Ipilimumab (1 mg/kg) will be administered as a 30 minute IV infusion (-10min/+15min) every 6 weeks for two doses.
~Drug: 1mg/kg IV"
15840819|NCT04117074|Drug|Liposomal bupivacaine|Surgical site infiltration with 20 mL liposomal bupivacaine prior to laparotomy closure.
15840820|NCT04117074|Other|Thoracic epidural analgesia (bupivacaine)|Perioperative bupivacaine based thoracic epidural placed preoperatively.
15840821|NCT04117061|Procedure|Observation|Patient after primary investigation is observed for 8-12 hours, (instead of being send directly to CT scan), after observation repeated clinical evaluation, laboratory tests and ultrasound examination are done , if final diagnosis stays unclear the patient is refered to CT scan.
15840822|NCT04117048|Device|LabPad® point-of-care|All at home INR measurements will be performed by the nurse using the LabPad® point-of-care
15840823|NCT04117035|Procedure|Gamma Knife Radiosurgery (GKRS) personalised procedure|Personalised GKRS treatment
15840824|NCT04117035|Procedure|GKRS standard care|Standard GKRS treatment
15840825|NCT04117022|Dietary Supplement|DVS supplementation|Oral supplement. Each subject will be given the carotenoid supplement of DVS formula. The DVS formula consists of vitamins C, D3 and E (d-α tocopherol), zinc oxide, eicosapentaenoic acid, docosahexaenoic acid, α-lipoic acid (racemic mixture), coenzyme Q10, mixed tocotrienols/tocopherols, zeaxanthin, lutein, benfotiamine, N-acetyl cysteine, grape seed extract, resveratrol, turmeric root extract, green tea leaf, and Pycnogenol (patented French Maritime Pine Bark extract, sp Pinus pinaster, Horphag Research, Geneva, Switzerland). Supplements bottles will be labelled with a unique identification number for each subject and supplied by ZeaVision, LLC, Chesterfield, Missouri, USA. To assure that the participants do not have any issues with the vitamin supplement and to ensure adequate adherence to schedule of vitamin intake the participants will get regular phone calls from the study investigators (once every two weeks).
15840826|NCT04117009|Drug|Remifentanil 2 MG|Once the participants transferred to operating room, electrocardiography, noninvasive blood pressure, pulse oximetry, and respiratory rate will be recorded. An increase or decrease from the baseline value of 30% in mean arterial pressure will be treated with iv boluses of (5 mg) ephedrine or glyceryl trinitrate (25 micg). All the participants will undergo a baseline transthoracic echocardiographic evaluation to assess the systolic and diastolic function of the left ventricle before the infusion of the study drug. Then the patients will be given oxygen by a face mask at a rate of 5-6 L/min, and Remifentanil infusion will be started using a target controlled infusion pump to reach a target plasma concentration of 2 ng/mL. Once the target concentration is reached, second echocardiographic evaluation to assess the systolic and diastolic function will be performed. Potential side effects of Remifentanil will be monitored.
15840827|NCT04117009|Diagnostic Test|Echocardiographic evaluation|Transthoracic echocardiographic examination will be performed in the spontaneously breathing patients right before the surgical procedure.
15840828|NCT04116996|Device|DEEP BRAIN STIMULATION|NEUROMODULATION
15840829|NCT04116983|Device|Deep Ensemble for the Recognition of Malignancy (DERM)|An AI-based diagnosis support tool
15840830|NCT04116970|Procedure|Bronchoscopy|Undergo bronchoscopy with EBUS-TBNA
15840831|NCT04116970|Procedure|Ultrasound-Guided Transbronchial Needle Aspiration|Undergo bronchoscopy with EBUS-TBNA
15840832|NCT04116957|Device|RTLS current tag|Validate location system performance against manual observation of nursing activity
15840833|NCT04116957|Device|RTLS tag revised|Test a next-generation RTLS tag for healthcare process validation
15840834|NCT04116944|Behavioral|Resistance exercise training|The ecologically-valid resistance exercise training was designed according to World Health Organization and American College of Sports Medicine guidelines. The eight-week, twice-weekly intervention was designed to be performed at a moderate intensity. The resistance of each exercise was such that when participants could successfully complete 2 sets of 12 repetitions at a certain load, the resistance was increased incrementally up to 5% for the following session. Exercise sessions were scheduled with at least one day of rest between sessions. The eight exercises included the barbell squat, barbell bench press, hexagon bar deadlift, dumbbell shoulder lateral raise, barbell bent over rows, dumbbell lunges, dumbbell curls, and abdominal crunches.
15840835|NCT04116944|Other|Wait-list|Participants randomized to the delayed-start wait-list condition completed questionnaires once-weekly. The investigator sent a weekly email to the participant providing links to the questionnaires. Participants that completed the eight-week wait-list condition were offered the eight weeks of RET either immediately upon completion, or later at a time of their convenience while the trial was ongoing. Each participant randomized to the eight-week wait-list also completed two 30-minute bouts of seated quiet rest in an empty room at weeks one and eight.
15840836|NCT04116931|Drug|Switch ticagrelor to clopidogrel|Switch ticagrelor to clopidogrel with 600 mg loading dose (LD)/75 mg maintenance dose（MD）12/24 hours after the last MD of ticagrelor
15840837|NCT04116905|Behavioral|Intensive Lifestyle Intervention|The lifestyle intervention is implemented with individual supervision sessions and is aimed at achieving and maintaining at least a 15% decrease in weight from baseline. It is implemented during a 12-month period with the most intensive application during the first 4 months. To help participants achieve and maintain weight loss, partial diet replacement with very low calorie diet, strengthend exercise strategies. Mobile phone applications (apps) will be used to manage metabolic syndrome during weight loss program. Optional medications on metabolic syndrome will be utilized based on a preset algorithm and participant progress.
15840838|NCT04116905|Behavioral|Conventional Treatment|Participants assigned to conventional treatment and education are offered metabolic syndrome management and social support every 1 month, aimed at achieving and maintaining a 5% decrease in weight in 1 year. Mobile phone applications (apps) will also be used in the weight loss program.
15840839|NCT04116892|Procedure|the Cover group|The internal limiting membrane around the MH was left to cover the hole
15840840|NCT04116892|Procedure|the Fill group|The internal limiting membrane around the MH was left to fill the hole
15840841|NCT04116892|Procedure|the peeling group|the internal limiting membrane was discarded
15840842|NCT04116853|Behavioral|ADAPTIVE Extended-Care Program|Each extended-care intervention phone call will be initiated by the interventionist, and will begin with a brief check-in followed by a discussion of any barriers experienced by participants in meeting their weight maintenance goals. Each call will end with a formal goal setting session. Calls are expected to last for approximately 10-20 minutes.
15840843|NCT04116853|Behavioral|STATIC Extended-Care Program|Each extended-care intervention phone call will be initiated by the interventionist, and will begin with a brief check-in followed by a discussion of any barriers experienced by participants in meeting their weight maintenance goals. Each call will end with a formal goal setting session. Calls are expected to last for approximately 10-20 minutes.
15840844|NCT04116840|Drug|MT1002 for injection|Study drug will be administered by an intravenous bolus dose followed by an infusion of 4 hours.
15840845|NCT04116827|Drug|Tamoxifen Oral Tablet|Patients who are scheduled for application of tamoxifen and goserelin
15840846|NCT04116814|Diagnostic Test|wall-to-lumen ratio measurement|wall-to-lumen ratio measurement in patients with renal insufficiency
15840847|NCT04116801|Procedure|microsurgical resection|resection of cerebral metastases by microsurgery
15840848|NCT04116788|Device|Artefact IRM assessment|IRM
15840849|NCT04116775|Biological|Fecal microbiota transplant|A total of 100 mL of a mixture of stool and saline will be transplanted via endoscopy once.
15840850|NCT04116775|Drug|Pembrolizumab|Pembrolizumab 200 mg administered as a 30 minute infusion every 3 weeks.
15840851|NCT04116775|Drug|Enzalutamide|Daily oral dose.
15840852|NCT04116762|Device|TissuePatchDS-P™|The therapy to be used in the intervention arm is TissuePatchDS-P™. This is a preformed, standard-sized artificial adhesive that will be used between the parotid tissue and subcutaneous tissue. It can be cut to an appropriate size for the defect. The intention of this installation is to seal and close the potential space that is created with removal of superficial parotid tissue
15840853|NCT04116762|Device|Surgical Drain|A surgical drain used in superficial parotid surgery is a thin polyvinylchloride (PVC) tube, with perforations at the end, which is placed at the end of the procedure before the surgical wound is closed in the cavity created following removal of parotid tissue. The tube is connected to a closed vacuum system attached to a plastic bottle outside of the patient's body which acts to remove the fluid that collects after an operation.
15840854|NCT04116749|Other|Water|Drink water freely until 2 hours before anesthesia.
15840855|NCT04116736|Device|ACUVUE® OASYS with Transitions™|JJVC Marketed Contact Lens
15840856|NCT04116736|Device|Silicone Hydrogel Contact Lens|Any reusable spherical silicone hydrogel brand that is approved and marketed in the country conducting the study.
15840857|NCT04116723|Device|Flexible brace|Participants will be invited to undergo a fitting session of a flexible brace. After the fitting session, participants will join a two-hours wear trial of the flexible brace. Participants are required to wear the brace for two-hours and undergo assessments before and after the wear trial. The measurement outcomes of the assessment include 1) X-ray scan, 2) 3D body scan, 3) garment pressure, and 4) questionnaire.
15840858|NCT04116710|Biological|HS-110 (viagenpumatucel-L)|Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
15840859|NCT04116710|Biological|HS-130|Vaccine derived from irradiated human lung cancer cells expressing the co-stimulatory fusion protein OX40L-Ig
15840860|NCT04116697|Other|Acupuncture|Acupuncture is a form of alternative medicine in which thin needles are inserted into the body.
15840861|NCT04116697|Other|Aromatherapy|Aromatherapy is a form of alternative medicine in which you will inhale aromatic plant extracts and essential oils.
15840862|NCT04116684|Device|Withings Digital Blood Pressure Monitor|This is a home digital blood pressure monitor that can transmit recordings via a user's smartphone.
15840863|NCT04116671|Device|Neuromechanical Gait Assist|A hybrid powered knee orthosis combined with surface muscle stimulation to assist walking.
15840864|NCT04116658|Biological|Multiple dose of EO2401|Multiple dose administration of EO2401 coadministered with or without nivolumab (and bevacizumab, US only) during the priming phase
15840865|NCT04116645|Other|genital and rectal swab|6. Swabs for GBS culture should be obtained, ideally before digital examination or use of lubricants, from both the lower vagina (vaginal introitus) and rectum (insert swab through the anal sphincter) to achieve maximum sensitivity. Either two swabs (one for each site) or a single swab can be used; one swab is more cost saving. The swabs will be obtained by the patient herself after appropriate instruction or by the provider healthcare, as studies have shown equivalent sensitivity between the healthcare provider and the patient herself.
15840866|NCT04116632|Drug|BMS-963272|Single dose with varying frequency among groups
15840867|NCT04116632|Drug|Placebo|Specified dose on specified days
15840868|NCT04116619|Other|Guided Imagery Laboratory Session|"On days 1, 2 and 3 of the study, subjects will come to the research testing rooms and be provided with lunch before beginning the laboratory session. After a 40-minute adaptation period, two blood samples will be drawn before imagery (BASELINE). After the second blood draw, a 5-minute baseline period will follow to assess continuous pulse rate, BP, and HRV assessments. The subject and research staff conducting the sessions will be blinded to the order and content of the imagery condition. In each recording, the subjects will listen to the scripts over headphones and will vividly imagine the described situation, 'as if' it were happening right now, for 5 minutes. The research nurse will take a blood draw immediately after the imagery (IMAGERY). After that, three recovery blood draws will be performed at 15-minute intervals (RECOVERY). We will analyze the total of six blood samples for levels of cortisol."
15840869|NCT04116606|Drug|Active JNJ-54175446|JNJ-54175446 is a novel, potent, selective, and brain-penetrant antagonist of the adenosine triphosphate (ATP)-gated P2X7 channel.
15840870|NCT04116606|Drug|Placebo|Matching placebo containing the same excipients
15840871|NCT04116593|Behavioral|Nutrition education|Our intervention will be school based nutrition education.Nutrition education session will be delivered using audio-visual techniques (audio-visual presentation).Components of eight educational sessions will include overview of 16 food groups of individual dietary diversity score (IDDS) chart, detail description of 16 food groups presenting dietary diversity, overview of basic food components, importance of consuming diversified foods, strategies to select a diversified meal and remove monotony in food, proper timing and frequency of taking meals during 24 hours, selecting diversified meal in low expense, consequences of absence or scarcity of dietary diversity in meal.
15840872|NCT04116580|Other|RAAP - for Raw Apple in connection with re-contact with the raw apple according to an Ultra-Rush protocol|
15840873|NCT04116554|Drug|0.25% bupivacaine.|20 mL of 0.25% bupivacaine and the same procedure will be repeated on the other side
15840874|NCT04116554|Device|0.9%saline|20 ml of 0.9%saline will be injected on each side
15840875|NCT04116541|Drug|HDM201|HDM201 120mg, Every 3 weeks, Per os
15840876|NCT04116541|Drug|Ribociclib|Ribociclib 200mg/day, once daily 2 weeks on/1 week off, Per os
15840877|NCT04116541|Drug|Cabozantinib|Cabozantinib, 60 mg /day, continuous, Per os
15840878|NCT04116541|Drug|Alectinib|Alectinib, 600mg twice daily, Per os
15840879|NCT04116528|Drug|Ketamine|0.5mg/kg
15840880|NCT04116528|Drug|Buprenorphine|Buprenorphine (0.2-0.8mg/day) or Placebo orally dissolving tablet
15840881|NCT04116528|Drug|Placebo oral tablet|Buprenorphine or Placebo orally dissolving tablet
15840882|NCT04116515|Behavioral|Xbox / active video games|The investigators would expect children to play active video games as a way to reduce their sedentary activities and increase their moderate and vigorous physical activities.
15840883|NCT04116515|Behavioral|Animated cartoon narratives|The investigators would expect the animated cartoon narratives to motivate children to play more active video games as a way to reduce their sedentary activities and increase their moderate and vigorous physical activities.
15840884|NCT04116515|Behavioral|Standard clinical care|Each clinic will provide standard clinical care to the participants.
15840885|NCT04116502|Drug|Ruxolitinib|10mg of ruxolitinib twice daily (bd)
15840886|NCT04116502|Drug|Hydroxycarbamide|Via standard hospital mechanisms
15840887|NCT04116502|Drug|Interferon-Alpha|Any formulation, via standard hospital mechanisms
15840888|NCT04116489|Other|Forest walk|Participants will be provided with an educational program about the forest and take a guided forest walk.
15840889|NCT04116489|Other|Wildlife rehabilitation|Participants will be provided with education on wildlife rehabilitation and assist with wildlife care such as feeding baby animals.
15840890|NCT04116489|Other|Wildlife sanctuary observation|Participants will be provided an educational program on wildlife care and accompany park game keepers during animal feeding and will observe iconic wildlife.
15840891|NCT04116489|Other|Bird feeding and watching|Participants will learn about bird identification and safe bird feeding. Bird feeders will be provided at the Soldier On facility for home bird feeding after study conclusion.
15840892|NCT04116476|Drug|MT-7117|Single Dose of MT-7117
15840893|NCT04116463|Behavioral|Chronic Disease Self-Management Program (CDSMP)|
15840894|NCT04116463|Behavioral|Financial Self-Management Program (FSMP)|
15840895|NCT04116450|Procedure|Glaucolight illuminated microcatheter.|To study circumferential trabeculotomy for congenital glaucoma using Glaucolight illuminated microcatheter.
15840896|NCT04116437|Drug|Zanubrutinib|Zanubrutinib (BGB-3111) will be orally administered at a dose of 160 mg twice daily or 320mg once daily until disease progression, unacceptable toxicity, treatment consent withdrawal, or study termination.
15840897|NCT04116424|Other|nurse training of the patient|visit + telephone follow-up
15840898|NCT04116424|Other|neurologist accompaniement|presentation during consultation by neurologist
15840899|NCT04116411|Drug|Valganciclovir Tablets|Valganciclovir treatment of glioblastoma
15840900|NCT04116411|Drug|Temozolomide 120 mg|Chemotherapy
15840901|NCT04116411|Radiation|Radiotherapy 60 Gy|Radiation therapy
15840902|NCT04116411|Drug|Placebo oral tablet|Placebo treatment of glioblastoma
15840903|NCT04116398|Drug|Dexamethasone with 2 loading doses followed by PRN regimen.|"Loading dose with 2 systematic intravitreal injections (IVI) of ozurdex at the baseline and 12 weeks.Followed by a PRN regimen with strict retreatment criteria (already used and published in the Prediamex study, Bellocq,Kodjikian et al Ophthalmology Retina 2017)
~Retreatment criteria: Reduction in VA ≥ 5 ETDRS Letters; and/or CSMT ≥ 275 microns by OCT-Cirrus® or ≥ 285 microns by OCT Spectralis®; and/or increase of CSMT > 50 microns; and/or onset of recurrent retinal cysts; and/or residual edema considered by the practitioner to be clinically significant.
~Minimal time limit between two IVI : 3 months
~Visits: monthly during 1 year (to check efficacy and safety) and then for the 2nd-year only at Month18 (M18) and Month 24 (M24)"
15840904|NCT04116385|Diagnostic Test|Quantra System|Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
15840905|NCT04116372|Behavioral|Digital Health Online Platform|"The website has 10 lessons that the participant will gain access to on a weekly basis. Lesson titles are as follows:
~Lesson 1 - Benefits of Physical Activity on Chronic Disease Lesson 2 - Mental benefits of Physical Activities Lesson 3 - Increasing Self Confidence for Physical Activities Lesson 4 - Learning about your Emotions Lesson 5 - Building Social Support Lesson 6 - Building Physical Activity Opportunity Lesson 7 - Goal Setting and Planning Lesson 8 - Self Monitoring Lesson 9 - Habit Lesson 10 - Identity"
15840906|NCT04116359|Drug|Cisplatin|Given IV
15840907|NCT04116359|Drug|Etoposide|Given IV
15840908|NCT04116359|Drug|Etoposide Phosphate|Given IV
15840909|NCT04116359|Drug|Molibresib|Given PO
15840910|NCT04116359|Drug|Molibresib Besylate|Given PO
15840911|NCT04116346|Other|Oral intake allowed|Oral intake (food and fluids) allowed up to the time of the procedure
15840912|NCT04116333|Device|Endotracheal tube introducer|Use of endotracheal tube introducer with the Macintosh laryngoscope on a manikin during continuous chest compressions with mechanical compression device.
15840913|NCT04116333|Device|Macintosh laryngoscope|Use of the Macintosh laryngoscope on a manikin during continuous chest compressions with mechanical compression device.
15840914|NCT04116320|Device|Echopulse|The Echopulse device delivers focused ultrasound ablation (FUSA) therapy. FUSA is a technology that delivers continuous high-intensity focused ultrasound to ablate tissue.
15840916|NCT04116320|Drug|Standard of Care PD-1 Therapy|PD-1 therapy FDA approved for use on a 3-week schedule will be used per standard of care.
15840917|NCT04116307|Dietary Supplement|Polymethylsiloxane|
15840918|NCT04116307|Dietary Supplement|Lactobacillus reuteri|
15840919|NCT04116294|Other|Computer-assisted prescription|The intervention is based on a computer-assisted prescription: when a PAR will be ordered, an alert will arise and explain the recognized indications for this examination and ask a confirmation for the prescription. This is a non-blocking system: physicians will be able to prescribe PAR even if the PAR is not appropriate.
15840920|NCT04116281|Other|Rehabilitation after breast cancer surgery|All participants are going to receive physical therapy intervention after breast cancer surgery at least removal drenaige. After that, will be randomized in two groups: Group 1 are going to receive a physical therapy program supervised by a physiotherapist; Group 2 are going to receive some instructions about the same program to perfomr at home without supervision. Both groups are going to receive 3 and 6 months of rehabilitation program.
15840921|NCT04116255|Other|Mandibular oral occlusal splint|The panoramic open-mouth and close-mouth radiographs of the first group(splint group) were taken, and intraoral and extraoral examinations were performed by an experienced dentist that also examined the radiographs. The upper jaw of the patients was measured with an alginate impression material, to obtain a hard plaster model. Then, using these models, a vacuum plate machine made a customized mandibular oral occlusal splint suitable for each patient's teeth. The suitability of the splints was checked and confirmed by the dentist on the first and seventh days of use. The patients were asked to use these splints at night (for at least six hours) throughout the study.
15840922|NCT04116255|Other|Temporomandibular joint Exercises|This program was created by combining patient training and a home exercise program. The exercise program consisted of slow passive and active mouth opening and closing exercises, isometric masseter exercises, mouth stretching exercises, and resistant mouth opening and closing exercises. Each exercise set was administered twice a day, and each movement was undertaken for 10 seconds and repeated 15 times. The training was given by an experienced physical medicine and rehabilitation expert over approximately 45 minutes. The exercise program was demonstrated for the patients in front of a mirror, and each exercise was performed by a set of patients under the supervision of a doctor. A training document including the written exercise program was to the patients in the exercises group.
15840923|NCT04116242|Other|blood sampling for research purpose|blood sampling for research purpose (about 30ml) taken by venepuncture or from intravenous catheters if already in place
15840924|NCT04116242|Other|clinical data collection|clinical data collection in order to document the stage of disease, the presence of infection and existing complications of cirrhosis (ascites, hepatic encephalopathy, renal dysfunction, pulmonary dysfunction) and concomitant disease. These data will be collected for clinical reasons as highly important in the context of patients with cirrhosis and possible decompensation or liver failure and will therefore not require additional time
15840925|NCT04116242|Other|Health-related Questionnaires|Health-related Questionnaires (Questionnaire_CLD) regarding sleep characteristics (Pittsburgh sleep Quality index, PSQI), daytime sleepiness (Epworth sleepiness scale, ESS), anxiety and depression (Hospital Anxiety and Depression Scale, HADS) and quality of life (EQ-5D-5L)
15840926|NCT04116242|Other|Sampling other biological materials (e.g. liver biopsies, liver resections, ascites, urine, gut biopsies)|Other biological material (e.g. liver biopsies, liver resections, ascites, urine, gut biopsies) will only be investigated if sampled for clinical reasons and if excessive material is available that is not needed for clinical purpose.
15840927|NCT04116229|Procedure|Oral glucose tolerance test|After 8 hours fasting overnight, an intravenous catheter is placed in the arm or hand for blood draws. Participants drink 75 grams of an oral glucose drink after baseline blood samples are drawn. More blood draws occur at 10, 20, 30, 60 and 120 min post-glucose drink.
15840928|NCT04116229|Behavioral|Cognitive testing|For approximately 40 minutes, participants are assessed for cognitive function using computer-based tests available from the NIH Toolbox Cognitive Battery (Weintraub et al., 2013), including attention and executive functioning, episodic memory, working memory, language, processing speed, and immediate recall.
15840929|NCT04116229|Procedure|Magnetic resonance imaging|Magnetic resonance imaging (MRI) scans will be performed in a 3 Tesla MRI scanner over 1.5 hours. Participants will be asked to lay down flat on their backs and to try to stay still throughout the MRI scan. The participant will wear MRI-safe headphones to block out noise due to the MRI scans. Participant comfort will be verbally checked on throughout the scan and the participant will be provided with a 'squeeze ball' to signal the MRI technician that they want to get out of the scanner immediately.
15840930|NCT04116216|Combination Product|High frequency repetitive transcranial magnetic stimulation|The sessions will be performed five times a week for two weeks. The individuals will be performed the following protocol: first the coil center will be positioned over Cz for the first 1000 pulses. Then the coil will be moved to C4 and C3, where 1000 pulses will be delivered to each hemisphere. The intensity will be set to 100% of the motor threshold. The high frequency stimulation will be delivered at 10 Hz, offered in 20 50-pulse trains, with 30-second train intervals. The low frequency will be performed at 1 Hz. After rTMS, patients will be submitted to 40 minutes of physical therapy protocol.
15840931|NCT04116216|Combination Product|Low frequency repetitive transcranial magnetic stimulation|The sessions will be performed five times a week for two weeks. The individuals will be performed the following protocol: first the coil center will be positioned over Cz for the first 1000 pulses. Then the coil will be moved to C4 and C3, where 1000 pulses will be delivered to each hemisphere. The intensity will be set to 100% of the motor threshold. The high frequency stimulation will be delivered at 10 Hz, offered in 20 50-pulse trains, with 30-second train intervals. The low frequency will be performed at 1 Hz. After rTMS, patients will be submitted to 40 minutes of physical therapy protocol.
15840932|NCT04116216|Combination Product|Sham repetitive transcranial magnetic stimulation|For sham stimulation, the stimulator positioned behind the patient will be turned off immediately after the determination of RMT, however, the coil will remain positioned over the patient's scalp (Cz, C3 and C4). A computer equipped with speakers will play an audio recording with the characteristic rTMS sound and no stimulation will be induced in the brain.
15840933|NCT04116203|Drug|Metformin|Manufacturer's standard 500 mg. Submission Control No.:128147
15840934|NCT04116203|Combination Product|Fish Oil and Metformin|Combo of 2 other arms
15841006|NCT04115644|Drug|Marcaine (placebo)|Group 1 (control): will receive an injection of 5 cc 0.25% Marcaine without epinephrine
15840935|NCT04116203|Dietary Supplement|Fish Oil|NPN: 80028808 Licence Holder: WN Pharmaceuticals Ltd Dosage Form: Capsule, soft Recommended Route of Administration: Oral
15840936|NCT04116190|Behavioral|Telerehabilitation|Short inpatient multidisciplinary rehabilitation followed by home-based telerehabilitation and a short evaluation period at the end of it.
15840937|NCT04116190|Behavioral|Conventional inpatient rehabilitation|Multidisciplinary inpatient rehabilitation, no adjustments due to the study.
15840938|NCT04116177|Device|Deep brain stimulation|Stimulation using VerciseTM system
15840939|NCT04116164|Drug|111In-DOTA-h11B6|4-6 mCi 111In labeled to 2 mg DOTA-h11B6; 0, 8 or 18 mg additional h11B6.
15840940|NCT04116151|Combination Product|Cosmetic cream (Alantel (R): aloe vera, chamomile and thime)|Application on the affected skin of the cream to be tested
15840941|NCT04116151|Combination Product|Placebo|Harmless moisturizing substance
15840942|NCT04116138|Dietary Supplement|Salovum|Egg yolk powder enriched for anti secretory factor
15840943|NCT04116125|Procedure|Radiotherapy|Adjuvant radiotherapy on axillary region
15840944|NCT04116112|Drug|Nicardipine|In the event where SBP values are above the randomly assigned target, intravenous nicardipine will be initiated at 2.5 mg/hr to lower the SBP. If SBP is still not reduced to below assigned target after 15 minutes, nicardipine dose will be increased by 2.5 mg/hr every 15 minutes until the target SBP or a maximum dose of 15 mg/hr is reached.
15840945|NCT04116112|Drug|Labetalol|If SBP is above target despite maximum nicardipine infusion for 30 minutes, 10-20 mg of intravenous labetalol will be added every 15 minutes.
15840946|NCT04116112|Drug|Hydralazine|If SBP remains unresponsive for 1 hr despite the use of maximum doses of nicardipine and labetalol, a Hydralazine will be added at the treating physician's discretion. Incidence of the latter scenario is anticipated to be exceedingly rare.
15840947|NCT04116099|Other|Conservative care|May include graduated compression, MLD performed by a licensed therapist, self-MLD, and instruction on exercise and skin care.
15840948|NCT04116099|Device|Flexitouch Plus|Flexitouch Plus treatment.
15840949|NCT04116086|Diagnostic Test|Prostate Biopsy Test|see earlier information
15840950|NCT04116073|Drug|INCMGA00012 (PD-1 antibody)|"Treatment of INCMGA00012 will be administered every 4 weeks (28 days) while patient is on study. Intravenous administration of INCMGA00012 (500 mg) will occur on Day 1 of each 28 day cycle.
~Drug: 500 mg is to be administered as a 30 minute IV infusion (-5/+15 min)"
15840951|NCT04116060|Dietary Supplement|Dietary Nitrate|Oral dietary nitrate supplementation with (0,12 mmol/kgBW sodium-nitrate)
15840952|NCT04116060|Dietary Supplement|Control|Placebo Comparator: Dietary sodium-chloride dissolved in water (0,12 mmol sodium-chloride/kgBW/day)
15840953|NCT04116047|Drug|Cisplatin|
15840954|NCT04116047|Drug|Durvalumab|
15840955|NCT04116047|Procedure|Radiotherapy|
15840956|NCT04116047|Procedure|Dose-escalated radiotherapy|
15840957|NCT04116034|Device|alfapump DSR system|Infusion of sodium free Dextrose 10% into peritoneal cavity to remove sodium and fluid using principles of peritoneal dialysis, sodium and ultrafiltrate will be evacuated to the bladder by the alfapump
15840958|NCT04116021|Other|PECS block|Ultrasound-guided PECS block before surgical incision with 30 mL bupivacaine 0.5 %
15840959|NCT04116021|Other|Local infiltration|Wound infiltration at the end of surgery with with 30 mL bupivacaine 0.5 %
15840960|NCT04116008|Other|Standard Pain Followup and Monitorization|Numeric Rating Scale (NRS) pain score will be recorded from recovery room followed by 2.-4.-6.-12.-24.hours. Intravenous meperidine administration at 0.5 mg / kg rescue analgesia was determined in patients with a NSR score of 4 and over in the postoperative collection room. It is planned that the patient will continue to follow the hourly NRS score in ward. Intramuscular diclofenac will be administered in this period if NRS 4 and if it is over, intravenous 0.5 mg / kg meperidine will be administered if NRS score is 4 or more after 2 hours. Salvage analgesic needs and times will be noted in detail, and the use of rescue analgesics, as well as NRS scores at designated hours, will be kept in a statistical evaluation.
15840961|NCT04115995|Diagnostic Test|Dynamic infrared thermography (DIRT) and indocyanine green fluorescence angiography (ICG-FA)|DIRT and ICG FA are used intraoperatively to evaluate perfusion of the perforators and the anastomosis. Both technique are compared in their ability to visualize perfusion.
15840962|NCT04115982|Drug|Cholecalciferol|One vial every 15 days during 2 months
15840963|NCT04115982|Drug|Placebos|One vial every 15 days during 2 months
15840964|NCT04115956|Drug|Melphalan-Flufenamide (Melflufen)|Treatment consist of i.v. melflufen on Day 1 of each 28-day cycle.
15840965|NCT04115956|Drug|Dexamethasone|Dexamethasone 40 mg (20 mg at investigator's discretion) administered on Days 1 and 2 of each 28-day cycle.
15840966|NCT04115943|Other|Treatment protocol for neck pain|The protocol to be used in the study is in accordance with the latest guidelines for the treatment of neck pain associated with limited mobility for patients in the chronic phase. The followed techniques will be performed: i) manual therapy - manipulation or mobilization of the upper cervical spine, manipulation or mobilization of the cervical, cervicothoracic and thoracic regions, manual cervical traction, release of the cervical muscles and muscles of the scapulothoracic region; ii) exercises - strengthening and resistance exercises for the muscles of the scapular girdle, coordination, proprioception and postural training of the cervical and scapulothoracic regions.
15840967|NCT04115943|Other|Protocol for release of tongue muscles|. The aim is the relaxation of the suprahyoid muscles (mylohyoid, geniohyoid, digastric and stylohyoid) as well as the cervical fascia of the anterior region and soft tissues of the region of the pharynx and larynx.
15840968|NCT04115930|Device|Physical Activity measurement:|7 days measurement with Active style Pro HJA-350IT device
15840969|NCT04115917|Device|Schocket scleral depressor|Scleral Depression on eye with Schocket scleral depressor
15840970|NCT04115917|Device|Cotton tipped applicator|Scleral Depression on eye with cotton tipped applicator
15840971|NCT04115904|Procedure|Ibuprofen for post operative pain|All treatment sessions were approximately 45 minutes in length to allow for acceptable time for completionof treatment and retreatment in one or two visits. Allthe clinical procedures were performed by the author.Following local anesthesia with 2% lidocaine with1:100,000 epinephrine (Septodont Saint-Maur desFossés, France) and rubber dam isolation the toothwas disinfected with 5.25% NaOCl (Ultra bleach,Bentonville, AR, USA).
15840972|NCT04115891|Other|Anxiety scale|Anxiety Face Image Scale (FIS) assessment in a separate room with face to face interview.
15840973|NCT04115891|Other|Pain scale - 1|Face, Legs, Activity, Cry, Consolability (FLACC), to assess objective operational pain after anesthesia injection and tooth extraction
15840974|NCT04115891|Other|Pain scale - 2|Wong Baker Pain Rating scale (WBS), to assess subjective operational pain after anesthesia injection and tooth extraction
15840975|NCT04115891|Behavioral|Inhalation|lavender oil inhalation in a separate room for 3 minutes prior to interventions
15840976|NCT04115878|Drug|Atomoxetine and oxybutynin (ato-oxy)|Low dose ato-oxy will include 0.5 mg/kg/day of atomoxetine (max 40 mg) in combination with 5 mg oxybutynin High dose ato-oxy will include 1.2 mg/kg/day atomoxetine (max 80 mg) and 5 mg oxybutynin
15840977|NCT04115865|Device|Endotracheal sonde or laryngeal mask|Healthy subjects ; requiring general anesthesia with endotracheal or endobuccal device
15840978|NCT04115852|Behavioral|fmri|functional magnetic resonance imaging
15840979|NCT04115839|Drug|Filgotinib|Tablets will be administered orally once daily with or without food.
15840980|NCT04115839|Drug|Placebo to match filgotinib|Tablets administered orally once daily with or without food.
15840981|NCT04115826|Procedure|Per-oral Pancreatoscopy-guided Lithotripsy|Per-oral Pancreatoscopy-guided lithotripsy will be administered for a maximum of 4 sessions (1 hour max per session). Either electrohydraulic lithotripsy or laser lithotripsy will be allowed during the session at the discretion of the endoscopist.
15840982|NCT04115826|Procedure|Extracorporeal Shock-Wave Lithotripsy|ESWL will then be performed with the patient in either slight left or right lateral decubitus with shock waves entering the body from the ventral side. The shockwaves will be focused first on the most distally located stone within the main duct and then on other calculi moving from the head towards the body. If a stent has been inserted during preceding ERP then this may also serve as a guide to target main pancreatic duct stones by ESWL. A total of one hour of ESWL at a rate of 60-120 shocks/minute will be delivered in one treatment session.
15840983|NCT04115813|Behavioral|Project YES! Youth Engaging for Success|Participants in the intervention were offered once a month one-on-one meetings and group meetings with their assigned youth peer mentors over approximately six months. The participant's caregiver could also attend up to 3 caregiver support groups held at the clinic (every other month). In addition, intervention participants in the children's hospital were assessed (clinical and psycho social factors) for physical transition to an adult clinic. After midline data collection, the intervention arm went into a maintenance phase, meeting with the youth peer mentor every other month (3 times). Participants in the comparison arm after midline started the Project YES! intervention as described above. Primary analysis was conducted using midline data.
15840984|NCT04115800|Drug|Liposomal Sirolimus|Subconjunctival injections of liposomal sirolimus in patients with conventional treatment with moderate and severe dry deye disease
15840985|NCT04115774|Drug|bisphosphonates|Since this is an observational study, the investigators collect general information on bisphosphonates treatment/impact
15840986|NCT04115761|Biological|autologous dendritic cells|The total 10 doses (1 mL/dose; 2±0.5 × 10^7 cell/dose) of ADCV01 will be administered to patients assigned to the investigational group. The ADCV01 will be administered to the bilateral subaxillary subcutaneous regional lymph nodes (half of volume about 0.5 mL of ADCV01) once weekly for the first 4 doses, and the following 2 treatments will be administered bi-weekly. The last 4 treatments will be administered every 4 weeks.
15840987|NCT04115748|Drug|Filgotinib|Tablets administered orally once daily with or without food
15840988|NCT04115748|Drug|Adalimumab|Injection administered subcutaneously once every 2 weeks
15840989|NCT04115748|Drug|Placebo to match filgotinib|Tablets administered orally once daily with or without food
15840990|NCT04115748|Drug|Placebo to match adalimumab|Injection administered subcutaneously once every 2 weeks
15840991|NCT04115722|Other|IBD ACTIVIT|Effect of IBD disease and activity of disease on coagulation parameters
15840992|NCT04115709|Device|Beacon Caresystem device with advice|Beacon Caresystem device provides ventilator settings advice to Doctors
15840993|NCT04115709|Device|Beacon Caresystem device without advice activated|Beacon Caresystem device does not give ventilator settings advice
15840994|NCT04115696|Device|Percutaneous placement of biodegradable biliary stents|The bening biliary strictures stents used in this register are made of polydioxanone (PPDX) (Ella-DV biliary stent, ELLACS, Hradec Králové, Czech Republic). The stents are implanted using a percutaneous transhepatic cholangiography using the standard micropuncture technique. Before stent implantation, balloon bilioplasty may be performed.
15840995|NCT04115683|Other|Dual Task Training|45 minutes of dual task training consisting of motor activities (walking, balance... etc.) with combination of cognitive activities (spelling words, image description, nomination, word generation, counting... etc.) at sime time.
15840996|NCT04115683|Other|Single Task Training|45 minutes of single task training consisting of same motor activities (walking, balance... etc.)
15840997|NCT04115670|Behavioral|Group of educational intervention on the neurophysiology of pain and physical exercises|"The physiotherapist of the institution will execute the intervention on the group:
~3 first pedagogical sessions on the neurophysiology of pain, distributed: 1 group session, 1 individual session at home, 1 in a personal interview format. These 3 sessions will last 2 weeks to be completed.
~Afterward, the protocol of physical exercise training will begin, supervised by the same physiotherapist who carried out the three initial sessions. There will be 15 sessions of specific and individualized physical exercise, in small groups of maximum 5 people. The duration of this part will be 10 weeks, so that from week 1 to 5 is 2 times per week, and from week 6 to 10 just 1 time per week."
15840998|NCT04115670|Behavioral|Control group|The control group will follow its normal course of activity
15840999|NCT04115657|Other|Starch 1|Consumption of milk tea with sucrose and boba pearls made from tapioca starch
15841000|NCT04115657|Other|Starch 2|Consumption of milk tea with sucrose and boba pearls made from high amylose
15841001|NCT04115657|Other|Starch 3|Consumption of milk tea with sucrose and boba pearls made from kithul flour
15841002|NCT04115657|Other|Starch 4|Consumption of milk tea with sucrose and boba pearls made from sago flour
15841003|NCT04115657|Other|Sugar 1|Consumption of milk tea with pure palatinose and boba pearls made from tapioca starch
15841004|NCT04115657|Other|Sugar 2|Consumption of milk tea with blend of sucrose and palatinose and boba pearls made from tapioca starch
15841005|NCT04115644|Drug|Ketorolac|Group 2 (ketorolac): will receive an injection of 3 cc 0.25% Marcaine without epinephrine and 2 cc ketorolac 30 mg/ml
15841007|NCT04115644|Drug|Kenalog|Group 3 (kenalog): 4 cc 0.25% Marcaine without epinephrine and 1 cc triamcinolone.
15841008|NCT04115631|Drug|Acalabrutinib|Given PO
15841009|NCT04115631|Drug|Bendamustine|Given IV
15841010|NCT04115631|Drug|Bendamustine Hydrochloride|Given IV
15841011|NCT04115631|Drug|Cytarabine|Given IV
15841012|NCT04115631|Biological|Rituximab|Given IV
15841013|NCT04115618|Radiation|Simultaneous integrated boost intensity-modulated chemoradiotherapy|Using IMRT technology, two fields are irradiated synchronously, prescription radiation dose: 50.4 Gy/28F in PTV-C, 1.8 Gy per fraction; 63 Gy/28F in PTV-G, 2.25 Gy per fraction. Six times of concurrent DP week regimen chemotherapy: cisplatin 20mg/m2 qw plus docetaxel 20mg/m2 qw.
15841014|NCT04115605|Device|Altis Single Incision Sling|Minimally invasive system including permanently implantable synthetic suburethral sling for the surgical treatment of female Stress Urinary Incontinence
15841015|NCT04115592|Other|Cocoa butter|Consumption of cocoa butter made with chocolate confectionery
15841016|NCT04115592|Other|Cocoa butter oleogel|Consumption of cocoa butter oleogel made with chocolate confectionery
15841017|NCT04115592|Other|Sal seed oil|Consumption of sal seed oil made with chocolate confectionery
15841018|NCT04115592|Other|Sal seed oleogel|Consumption of sal seed oleogel made with chocolate confectionery
15841019|NCT04115579|Other|Biscuit 1 Control|Consumption of control biscuit of a higher glycaemic index at one session during breakfast and afternoon snack
15841020|NCT04115579|Other|Biscuit 2 Test|Consumption of test biscuit of a lower glycaemic index at one session during breakfast and afternoon snack
15841021|NCT04115553|Diagnostic Test|MRI examination|Subjects will be placed in supine position. The systematic use of a headset will reduce the noise inherent to the machine. Standard MRI examination using a 32-channel head coil consists of angiographic, morphological and phase-contrast 2D flow sequences. The flow planes are set perpendicularly to the structure axis (blood or CSF regions). The velocity measured in the pixels inside the region of interest allow the calculation of a mean flow rate as well as the volume displaced during a cardiac cycle.
15841022|NCT04115553|Diagnostic Test|ECG|A cardiac synchronization system using peripheral ECG allows the synchronization with the subject's heart rate.
15841023|NCT04115540|Device|TENS penile nerve stimulation|The electrode pads of the transcutaneous electrical nerve stimulation (TENS 7000) will be placed at the base of the penis (and perineum) to stimulate the penile nerves.
15841024|NCT04115527|Procedure|Extended Lymphadenectomy|Lymph node dissection includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 16 17a 17b lymph nodes
15841025|NCT04115527|Procedure|Standard Lymphadenectomy|Lymph node dissection includes No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b lymph nodes
15841026|NCT04115514|Drug|Liothyronine Sodium (T3) (modified formulation)|Liothyronine Sodium (T3), 5-10-25-50µg instilled directly into the airways in a total volume of 10 ml (T3+0.9% sodium chloride). Progressive dosing every 24 hours for total 96 hours.
15841027|NCT04115501|Other|Fraction of Inspired Oxygen|Fraction of Inspired Oxygen during cardiac surgery, including cardiopulmonary bypass
15841028|NCT04115488|Biological|Intravenous (IV) infusions|Intravenous (IV) infusions of a dose of 300mg, every 4 weeks with a total of 12 doses
15841029|NCT04115475|Device|Multispectral Optoacoustic Tomography (MSOT)|Non-invasive transcutaneous imaging of subcellular muscle components
15841030|NCT04115462|Drug|Morphine|A 20 mg tablet of morphine
15841031|NCT04115462|Drug|Placebo oral tablet|Matching tablet of placebo
15841032|NCT04115462|Drug|Histamine|Histaminergic itch will be evoked by a 1% histamine solution. A droplet of histamine solution will be placed on the predetermined area on the forearm, and the SPT lancet will be pierced through the histamine with 120 g of pressure for 1-2 seconds.
15841033|NCT04115462|Drug|Cowhage (Mucuna Pruriens)|25 spicules will be inserted in the centre of the predefined skin area on the forearm. The spicules will be gently rubbed for 15-20 seconds in circular motion to facilitate epidermal penetration
15841034|NCT04115462|Drug|isotonic saline|A droplet of saline (0.9%) as vehicle control will be placed on the predetermined area on the forearm and the lancet will be pierced through the droplet.
15841035|NCT04115462|Drug|Histamine|Histaminergic itch will be evoked by a 1% histamine solution. A droplet of histamine solution will be placed on the predetermined area on the mandibular area, and the SPT lancet will be pierced through the histamine with 120 g of pressure for 1-2 seconds.
15841036|NCT04115462|Drug|Cowhage (Mucuna Pruriens)|25 spicules will be inserted in the centre of the predefined skin area on the mandibular area. The spicules will be gently rubbed for 15-20 seconds in circular motion to facilitate epidermal penetration
15841037|NCT04115449|Drug|Dexmedetomidine|Injection dexmedetomidine 1 mcg /kg will be infused over a period of ten minutes
15841038|NCT04115449|Drug|normal saline|Normal Saline as a placebo will be infused over a period of ten minutes
15841039|NCT04115423|Drug|Tocilizumab|A humanized monoclonal antibody against the interleukin-6 receptor, which is mainly for the treatment of rheumatoid arthritis.
15841040|NCT04115423|Drug|Tumor Necrosis Factor Inhibitor (etanercept, infliximab, adalimumab, and golimumab)|Tumor Necrosis Factor inhibitors (TNFi) are a group of medicines that suppresses the physiologic response to TNF, a protein involved in early inflammatory events. We will include etanercept, infliximab, adalimumab, and golimumab as TNFis since these drugs are commercialized in Korea.
15841041|NCT04115410|Drug|PD-1 inhibitor|PD-1 inhibitors are a group of checkpoint inhibitors being developed for the treatment of cancer. PD-1 and PD-L1 are both proteins present on the surface of cells. Immune checkpoint inhibitors such as these are emerging as a front-line treatment for several types of cancer. The investigators will include nivolumab, pembrolizumab, and atezolizumab as PD-1 inhibitors as these drugs are reimbursed by health authority of South Korea.
15841042|NCT04115410|Drug|Chemotherapy Drugs, Cancer|Chemotherapy is a type of pharmacotherapy for cancer, that uses one or more anti-cancer drugs as part of a standardized chemotherapy regimen. The investigators will include cytotoxic chemotherapy and tyrosine kinase inhibitors (epidermal growth cell receptor (EGFR) and anaplastic lymphoma kinase (ALK) inhibitors).
15841043|NCT04115397|Drug|Zoledronic Acid|Treating seropositive individuals with musculoskeletal symptoms with one infusion zolendronic acid as compared to placebo
15841044|NCT04115397|Drug|Placebo|Placebo
15841102|NCT04114942|Behavioral|Constant Coach|20 weeks of didactic training and 10 weeks of internship, with coaching throughout.
15841045|NCT04115384|Drug|Novolin-R insulin|Insulin (Novolin-R) 20 IU/IN (0.1ml/10 units IN in each nostril), twice per day, once in the morning and again in the evening (at least 8 hours between doses) for 4 weeks.
15841046|NCT04115371|Behavioral|Intervention|Geriatric assessment and care coordination provided by a multidisciplinary team in the emergency department including transitional care nurses, social workers, pharmacists, occupational therapists, and physical therapists.
15841047|NCT04115358|Procedure|Hyaluronic acid: Gengigel teething|Applying of 0,54% hyaluronic acid for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crowns and composite filling material.
15841048|NCT04115358|Procedure|Formocresol Buckley formula: Formacresol|Applying of 1/5 diluted formocresol for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crowns and composite filling material.
15841049|NCT04115358|Procedure|Ferric sulfate: ViscoStat|Applying of 20% ferric sulfate for one minute to the orifice of root canals of the primary molars, then sealing the chamber with zinc oxide eugenol cement and completing the restoration with stainless steel crowns and composite filling material.
15841050|NCT04115345|Biological|REACT - renal autologous cell therapy|Renal Autologous Cell Therapy (REACT) is made from expanded autologous selected renal cells obtained from each individual subject's kidney biopsy. To manufacture REACT, biopsy tissue from each enrolled subject will be sent to Twin City Bio LLC, in whose facilities renal cells will be expanded and SRC selected. SRC will be formulated in a gelatin-based hydrogel at a concentration of 100 x 106 cells/mL, packaged in a 10 mL syringe, and shipped to the clinical site.
15841051|NCT04115332|Biological|bio-feedback training|The aim of this study was to explore the abused PW nurses who receiving bio-feedback training as an intervention improve, and change of physiological indicators before and after intervention (3 months later), which included Respiratory Rate (RR), skin conduction (SC), heart rate variability (HRV), and resilience.
15841052|NCT04115319|Drug|SEP363856|SEP-363856, 50mg, 75mg, 100mg, flexibly dosed once daily capsule
15841053|NCT04115319|Drug|quetiapine XR|quetiapine XR, 400, 600, 800 mg, flexibly dosed once daily capsule
15841054|NCT04115306|Drug|PMD-026|Oral RSK1-4 inhibitor
15841055|NCT04115293|Drug|zilucoplan (RA101495)|Daily subcutaneous (SC) injection
15841056|NCT04115293|Drug|Placebo|Daily subcutaneous (SC) injection
15841057|NCT04115280|Diagnostic Test|Primary Hyperaldosteronism diagnostic|blood sample to obtain the aldosterone to renin ratio
15841058|NCT04115267|Radiation|Radiotherapy|Combined modality
15841059|NCT04115254|Radiation|MR-guided Linac|Radiation will be delivered on an MR-guided Linear Accelerator
15841060|NCT04115241|Device|Actigraph|Actigraphs are non-invasive, wearable devices that measure activity levels using an accelerometer
15841061|NCT04115241|Other|Grip strength test|The purpose of this test is to measure the maximum isometric strength of the hand and forearm muscles
15841062|NCT04115228|Device|Implantation and neuromodulation therapy|The study device is an autonomous permanent implant for neuromodulation targeting the posterior tibial nerve. It does not require an external power source or charger.
15841063|NCT04115215|Behavioral|Physical exercise (PE)|This arm includes 10 sessions of multi-component exercise sessions (including aerobic, resistance, flexibility, dual-tasking) of 1 hour/week of functional group exercise, directed to foster empowerment for subsequent continuation of exercise in community-dwelling older adults referred by primary care to a geriatrician and an expert physical therapist. Participants will receive a leaflet with instructions to perform five strength-based exercises and instructors will recommend participants to perform the exercises and walk at least 15 minutes daily.
15841064|NCT04115215|Device|Transcranial current stimulation (tCS)|This arm includes 1 application/week for 10 weeks during PE, through an adapted commercial helmet. Transcranial current stimulation (tCS) is a neural stimulation technique based on electrical stimulation of selected parts of the brain with direct or alternated electrical current (tDCS or tACS) of very low intensity of 1,5 milliamps (mA), using one or more electrodes placed on the skull. tCS is non-invasive (no surgical procedures) and it is painless, as applied in the proposed protocols.
15841065|NCT04115215|Other|Control|Participants of similar profile, randomized to the control group, will undergo weekly 30 minutes educational sessions on healthy aging, including relevant aspects of nutrition, self-care, physical activity, plus measurement of blood pressure, heart rate and peripheral oxygen Hb saturation. These participants will be offered to join the PE program after the 6-months follow-up (end of the study).
15841066|NCT04115202|Procedure|lumbar arthrodesis|two approaches anterior versus posterior, optimally by leaving physicians free to use them as they do daily without modifying their procedures
15841067|NCT04115189|Drug|Sunitinib|Patients to receive Sunitinib as first line therapy for mRCC
15841068|NCT04115163|Drug|Gemcitabine|Given IV
15841069|NCT04115163|Drug|Nab-paclitaxel|Given IV
15841070|NCT04115137|Device|pelvic varicose veins plug embolization|pelvic varicose veins plug embolization
15841071|NCT04115124|Behavioral|Participatory Action Research|The research will employ a Participatory Action research quasi-experimental pre-post test study design .
15841072|NCT04115111|Drug|Durvalumab|Durvalumab in monotherapy as second line treatment
15841149|NCT04114513|Dietary Supplement|Beta-glucan|Tate & Lyle, white powder 5 weeks intervention
15841079|NCT04115085|Procedure|Hand therapy (18 treatments)|18 treatments (ea. 20 Min) within 9 weeks
15841080|NCT04115085|Procedure|Therapeutic ultrasound (18 treatments)|18 treatments (ea. 10 Min) within 9 weeks
15841081|NCT04115085|Procedure|Combined hand therapy and therapeutic ultrasound (18 treatments)|18 treatments (ea. 30 Min) within 9 weeks
15841082|NCT04115072|Drug|Praziquantel 600Mg Oral Tablet x 5|Five doses of Praziquantel 40 mg/kg
15841083|NCT04115072|Drug|Praziquantel 600Mg Oral Tablet x 1|Single dose of Praziquantel 40 mg/kg
15841084|NCT04115059|Drug|Dasatinib|Oral, daily, dosing per protocol, once a day for cycle
15841085|NCT04115046|Device|ShearWave Elastography (SWE) in Endoscopic Ultrasound (EUS)|ShearWave Measurement is a software option available on the ARIETTA 850 that uses transient pulses to generate shear waves in the body. The tissue's elasticity is directly deduced by measuring the speed of wave propagation.
15841086|NCT04115046|Device|FibroScan|manufactured by Echosens
15841087|NCT04115046|Device|ALOKA ARIETTA 850 -|manufactured by Hitachi Healthcare - included on the system is the ShearWave measurement software
15841088|NCT04115033|Device|Alpha-stim|The device for both groups is the Alpha-stim, a FDA-approved device similar to the Military Field Stimulator (MFS/Neuro-Stim System), a cranial electrical stimulation (CES) device.
15841089|NCT04115020|Drug|Naltrexone|Naltrexone 4.5 mg oral suspension
15841090|NCT04115020|Drug|Placebo|Placebo oral suspension
15841091|NCT04115007|Radiation|Stereotactic Body Radiotherapy (SBRT)|"Definition of standard of care (prior to randomization):
~Radiotherapy to the prostate in de novo metastatic patients Long-term Androgen Deprivation Therapy (ADT) with or without intermittent treatment. Additional therapy with abiraterone acetate or docetaxel following tumor board meeting.
~With the following radiotherapy modalities:
~SBRT is delivered using the following regimen: 30 Grays (10 Gy x 3 fractions) for axial and appendicular bones and lymph node metastases if present. In case the dose cannot be safely delivered while maintaining a safe dose to the organs at risk, an alternate regimen (35 Gy in 5 fractions of 7 Gy) can be used.
~In de novo metastatic patients: Prostate and seminal vesicle external beam radiotherapy using either 74-80 Gy with conventional fractionation (in fractions of 2 Gy) or using a hypofractionated regimen delivering 60 Gy (20 fractions of 3 Gy)."
15841092|NCT04115007|Drug|Standard of care|"Definition of standard of care (prior to randomization):
~Radiotherapy to the prostate in de novo metastatic patients Long term ADT with or without intermittent treatment. Additional therapy with abiraterone acetate or docetaxel following tumor board meeting."
15841093|NCT04114994|Diagnostic Test|Boston Cognitive Assessment (BoCA)|"The Boston Cognitive Assessment (BoCA) is a self-administered online test intended for longitudinal cognitive monitoring. BoCA uses random not-repeating tasks to minimize learning effects. BoCA was developed to evaluate the effects of treatment in longitudinal clinical trials and available gratis to individuals and professionals.
~BoCA includes eight subtests in the following domains: Memory/Immediate Recall, Memory/Delayed Recall, Executive function/ Visuospatial, Executive function/ Mental rotation, Attention, Mental math, Language/Prefrontal Synthesis, and Orientation. The maximum total score is 30. Higher score indicates better cognitive performance.
~After BoCA is completed, the domain scores and total score are provided immediately. Users will also receive an email with the link to the full report with progress charts."
15841094|NCT04114981|Radiation|Single Fraction Stereotactic Radiosurgery|Undergo SSRS
15841095|NCT04114981|Radiation|Fractionated Stereotactic Radiosurgery|Undergo FSRS
15841096|NCT04114981|Procedure|Quality-of-Life Assessment|Ancillary studies
15841097|NCT04114981|Other|Questionnaire Administration|Ancillary studies
15841098|NCT04114968|Other|GP-based screening or HPV self-sampling|Women in the intervention group will receive an invitation for HPV-based cervical cancer screening by either 1) scheduling an appointment for a cervical cytology by the GP or 2) collect a cervico-vaginal sample themselves in their own home using a self-sampling kit.
15841099|NCT04114955|Behavioral|Manas por Manas|Manas for Manas works at both the group- and individual-levels to increase self-care and reduce the negative health impacts of stigma, including: 1) a group-level, peer-led intervention, which first demonstrated efficacy with trans women in the US as 'Sheroes' and has been successfully adapted for Brazil, and 2) an individual-level peer navigation program.
15841100|NCT04114942|Behavioral|Never Coach|20 weeks of didactic training and 10 weeks of internship, but no coaching.
15841101|NCT04114942|Behavioral|Internship Only Coach|20 weeks of didactic training with no coaching and 10 weeks of internship with coaching.
15841103|NCT04114929|Other|Threshold-based Training|Specific ventilatory markers determined from a cardiopulmonary test and the correlating heart rate will be used to determine exercise intensity
15841104|NCT04114929|Other|Standard Care|Using the standard care cardiac rehabilitation guidelines exercise will be based on estimated heart rate maximum followed by the karvonan method to calculate 40-70% heart rate reserve
15841105|NCT04114916|Dietary Supplement|Apigenin, luteonin, grapefruit extract and citrolive|Two capsules daily at breakfast and dinner.
15841106|NCT04114916|Dietary Supplement|maltodextrina|Two capsules daily at breakfast and dinner.
15841107|NCT04114890|Drug|Tenofovir Disoproxil Fumarate|Tenofovir Disoproxil Fumarate 300 mg once daily and will continue until one month after delivery
15841108|NCT04114877|Behavioral|Attentional retraining (AR)|Cognitive bias modification (CBM) procedures are interventions aimed at changing the impulsive (automatic) processes that underlie unhealthy behaviors such as smoking. AR is the most commonly used CBM intervention in the study of addiction-related attentional bias. The idea behind AR is to reduce attentional bias and therefore minimize exposure to drug cues, because attention to such stimuli may provoke craving and undermine cessation attempts.
15841109|NCT04114877|Behavioral|Visual probe (VP)|The visual probe (VP) task can measure attentional bias for drug-related cues. In the typical VP task, a pair of pictures or words (e.g. one smoking-related and one neutral) is briefly presented simultaneously side by side on a computer screen. After the pictures disappear, a probe stimulus (e.g. a small dot) is presented in the location that had been occupied by one of the pictures (or words), and participants are required to press a key as quickly as possible in response to the probe. Attentional bias for drug-related cues is detected by a faster response to a probe that replaces a drug-related stimulus (vs. a neutral stimulus), since attention will have been preferentially allocated to that area of visual display. The traditional VP task only assesses attentional bias, and does not modify it in any way.
15841110|NCT04114864|Behavioral|Psycho-educational sessions|"Participants of clusters allocated to the ME-WE intervention group will complete a programme based on seven weekly sessions of approximately 2 hours each, plus a follow-up meeting after 3 months from the end of the programme. All sessions maintain a similar structure (objectives, ice-breaker, central activity/ies, and final activity). At the end of some sessions, participants will be asked to do some exercises at home, between one meeting and the next one, in order to keep what has been done during the previous session fresh in their minds.
~Contents of sessions will be as follows: (1) Getting to know each other; (2) The Advisor: dealing with annoying thoughts; (3) The Noticer: being in connection with our feelings; (4) The Discoverer: growing and thriving; (5) Values: connecting to meaning and vitality; (6) Developing a flexible self-view and self-compassion; (7) Building strong social networks."
15841111|NCT04114851|Device|NoL|NoL active
15841112|NCT04114825|Biological|RV001V|RV001V consists of the peptide RV001 and the adjuvant Montanide ISA 51. RV001 Vaccine 0.1 mg/mL (RV001V).
15841113|NCT04114825|Other|Placebo|Placebo consist of the vaccine vehicle and the adjuvant Montanide ISA 51. Placebo
15841114|NCT04114812|Other|Blended learning|In the intervention group, students will be given access to an e-learning platform that contains five e-learning modules. They will attend individual small group tutoring sessions, with a maximum of 4 students per group. They will be able to book these sessions at a dedicated web platform. They will have 16 weeks in which to complete the 5 e-learning modules and 16 hours of practical training. Progress will be monitored and supported by regular follow-up messages and calls by the study team. Students must hand in the logbook with tutors' signatures when they enter the exam. All students within the blended learning group that completed 5 hours of e-learning as well as 16 hours of peer-tutoring and passed a predefined total score in the test directly after the intervention will receive a course certificate. Students not fulfilling all of these criteria will have the possibility to complete the program and/or re-do the test after the end of the study.
15841115|NCT04114812|Other|Standard course|In the standard course or control group, students will participate in a 2.5-day course in abdominal ultrasound, comprising 5 hours of lectures and 16 hours of ultrasound training in small groups, with a maximum of 4 students per group. The course will be held in an ultrasound training centre in Bern. All students within the standard course group that participated in the whole 2.5 day course and passed a predefined total score in the test directly after the intervention will receive a course certificate. Students not fulfilling all of these criteria will have the possibility to complete the program and/or re-do the test after the end of the study.
15841116|NCT04114799|Procedure|Hemodynamic management based on invasive fluid responsiveness parameters|In case of hypotension (reduction of MAP for more than 15% of individual blood pressure) the SPV value more than 8% will be used as a trigger for the bolus of 2 ml/kg of Plasmalyte (Baxter)
15841117|NCT04114799|Procedure|Hemodynamic management based on noninvasive cardiac output and SVV measurement|In case of hypotension (reduction of MAP for more than 15% of individual blood pressure) the systemic vascular resistance (SVR) value will be used to trigger norepinephrine infusion. In patients with low SVR norepinephrine infusion will be started. In patients with high SVR value either fluid bolus (in patient with SVV value above 8%), or dobutamine infusion (in patients with SVV value below or equal 8%) will be used.
15841118|NCT04114786|Device|3D-printed mask|After patient is enrolled to the study, patients will have CT Sim. MR Sim (used to create 3D printed mask for intervention arm only) CT sim repeat (for intervention arm only) before start of radiation Patients will be asked to fill out a questionnaire after each CT Scan, and during the first and last week of radiation treatment
15841119|NCT04114786|Device|Thermoplastic mask|Patients will undergo standard of care simulation, planning and treatment with conventional workflow using thermoplastic mask.They will complete the tolerability questionnaire after CT-sim, and towards the end of the first and last week of treatment.
15841145|NCT04114526|Other|Nicotine Replacement Therapy|"CHAs meet with all interested residents to discuss taking steps towards quitting. The CHAs follow a four step program with all participant 1) get to know the resident and their smoking, 2) Assess what the resident is ready to do to take steps towards quitting, 3) discuss using nicotine replacement therapy (NRT) in the form of patches, gum or lozenges, 4) set one goal for taking steps towards quitting. CHAs will attempt to follow up with participants after the initial encounter. There is no limit on the number of times the CHA may talk with the participants. Some follow interactions will be brief encounters in the neighborhood, while others will be at scheduled. All contacts with each participant will be tracked.
~We will provide up to 6 weeks of NRT patches, gum and lozenges to participants who are interested in using NRT to help them quit."
15841120|NCT04114773|Other|SCARF (Survivors of Cardiac Arrest Rehabilitation focused on Fatigue)|"The intervention will be delivered by a multidisciplinary team. There will be individual testing and feedback on physical capacity and cognitive ability. Group sessions will include education on the consequences of cardiac arrest, promotion of techniques to ameliorate these consequences, for example, increasing physical activity or energy conservation. Additional sessions will cover psychological reactions; family life; work life; intimacy; and existential considerations.
~Participants will have a course information book with a physical activity training diary and problem-solving therapy worksheets to use at home for 12-weeks. They will receive one phone call from the clinical team during this period. The 2-day return stay will revisit the subjects from the first 5-day stay.
~Participating survivors who have a relative that wishes to attend will be included in all the group sessions and individual feedback but will not take part in the physical capacity or cognitive ability tests."
15841121|NCT04114760|Device|patchy-type wireless ECG|This device consists of a single patchy and save the ECG result as a Potable Document Format. Also can transfer to hospital using wifi-network.
15841122|NCT04114760|Device|defibrillator ECG|This device is essential equipment in ambulance. For 12-lead ECG examination the connector need to replace for specific cable.
15841123|NCT04114747|Other|Starting at high or low blood pressure|Using norepinephrine, patients will receive high or low blood pressure to start with and after measurements cross to receive the other blood pressure target
15841124|NCT04114734|Behavioral|Park Rx|Participants will be advised to visit a specific park at a specific frequency and duration
15841125|NCT04114708|Diagnostic Test|Anterior cruciate ligament Reconstruction (ACLR)|All patients will undergo an anatomic ACLR via a standardized fashion using BTB autograft.
15841126|NCT04114708|Diagnostic Test|ACLR with lateral extra-articular tenodesis (LET)|All LETs will be performed in a standardized fashion using the modified Lameire technique. All patients will undergo an anatomic ACLR via a standardized fashion using BTB autogaft graft.
15841127|NCT04114682|Other|Multi parametric MRI scan|There will be no intervention to the standard of care these patients receive. However, consented participants will be asked to make two study visits where a multiparametric MRI scan will be performed - these visits will be defined as visit 2 and visit 3. An optional echocardiogram may be included at Visit 2.
15841128|NCT04114669|Behavioral|Control Condition|3 in-person study visits, approximately one hour each. These will take place at baseline, 6 months, and 12 months.
15841129|NCT04114669|Behavioral|Regret Lottery|"Delivered by the Way to Health platform, installed on a smartphone and communicates with participants via text message.Participants are eligible to receive a potential cash reward if they are adherent with their antihypertensive medication the day before, which is monitored via electronic monitoring device (EMD) from AdhereTech. Each participant is assigned a 2-digit number for the trial, and each day the Way to Health platform randomly generates a 2-digit number. Participants will receive a prize if both digits match (1 in 100 chance) and will receive a prize of lesser value if one digit matches (18 in 100 chance). If they are not adherent with their medication, but would have won if they were adherent, they receive a text message that they would have won (regret component)."
15841130|NCT04114656|Drug|Placebo|Placebo will be available as intravenous (IV) infusion of normal saline (0.9 percent [%] sodium chloride solution).
15841131|NCT04114656|Drug|GSK3858279|GSK3858279 will be available as IV infusion and the dose level to be administered is 3 mg per kilogram (kg).
15841132|NCT04114643|Biological|Prothrombin Complex Concentrate|Octaplex will be administered when the blood bank receives an order for coagulation factor replacement
15841133|NCT04114643|Biological|Frozen Plasma|Frozen Plasma will be administered when the blood bank receives an order for coagulation factor replacement
15841134|NCT04114630|Drug|erenumab 70mg/mL|Unit dose: 70 mg/mL single-dose., prefilled erenumab autoinjectors. 140 mg dose = 2 x 70 mg/mL, single dose, prefilled erenumab autoinjectors
15841135|NCT04114617|Other|Starch-thickened liquids|Thickener added in amounts required to reach slightly thick, mildly thick, moderately thick and extremely thick consistencies, as defined by the International Dysphagia Diet Standardisation Initiative flow test.
15841136|NCT04114617|Other|Xanthan-gum thickened liquids|Thickener added in amounts required to reach slightly thick, mildly thick, moderately thick and extremely thick consistencies, as defined by the International Dysphagia Diet Standardisation Initiative flow test.
15841137|NCT04114617|Combination Product|Barium concentration|Commercially available barium products diluted to different concentrations (i.e., 20% w/v, 40% w/v) through the addition of water
15841138|NCT04114617|Other|Food consistency|Commercially available food products in different consistencies: Carr's Table Water crackers, Squish gummy candies, baby carrots
15841139|NCT04114604|Other|Starch-based thickened liquids|Barium will be thickened to slightly, mildly, moderately and extremely thick consistences as defined by the International Dysphagia Diet Standardisation Initiative flow test.
15841140|NCT04114604|Other|Xanthan-gum thickened liquids|Barium will be thickened to slightly, mildly, moderately and extremely thick consistences as defined by the International Dysphagia Diet Standardisation Initiative flow test.
15841141|NCT04114591|Procedure|anterior resection|The distance from anal verge, preoperative radiotherapy and presence of stoma were analysed
15841142|NCT04114578|Other|Echocardiography|Echocardiography has become routinely used in the diagnosis, management, and follow-up of patients with any suspected or known heart diseases. It is one of the most widely used diagnostic tests in cardiology. It can provide a wealth of helpful information, including the size and shape of the heart (internal chamber size quantification), pumping capacity, and the location and extent of any tissue damage. An echocardiogram can also give physicians other estimates of heart function, such as a calculation of the cardiac output, ejection fraction, and diastolic function (how well the heart relaxes). The acquisition usually takes about 30 minutes.
15841143|NCT04114552|Other|questionnaires|"6 weeks after the trauma,during the call, an oral questionnaire will be proposed to collect data on patients' management since they have left the emergency department.
~After the call, socio-demographic characteristics, trauma mechanism, medics management will be extracted from the patient's medical records"
15841144|NCT04114539|Drug|Ecopipam|Ecopipam HCl 12.5-, 37.5-. 50-, 75- and 100-mg tablets; 2 mg/kg/day target dose; oral administration daily in evenings.
15841146|NCT04114513|Dietary Supplement|Maltodextrin|NOVAPRODUKT, white powder 5 weeks intervention
15841147|NCT04114513|Dietary Supplement|Inulin|BENEO-Orafti, white powder 5 weeks intervention
15841150|NCT04114513|Dietary Supplement|Galactooligosaccharides|FrieslandCampina, white powder 5 weeks intervention
15841151|NCT04114500|Diagnostic Test|serum estradiol and progesterone|blood sample for measuring serum estradiol and progesterone level on the same day of FET
15841152|NCT04114487|Other|dual task balance training|The studies were planned to be 2 times a week for 12 weeks. The 20-minute Dual Task balance training program is planned to be composed of two sections of 10 minutes. In the first 10 min section, the individual will exercise with the multi-task mode of CogniBoard on the balance ball. . Stroop study will be performed on the balance ball in the second 10 minutes of the exercise.
15841153|NCT04114474|Diagnostic Test|TRANSTHORACIC ECHOCARDIOGRAPY|TTE (Vivid I echocardiography machine General Electric Healthcare, Milwaukee, WI, USA) with a 3S-RS (1.5-3.6 MHz) transthoracic probe). was done by professional anesthesiologist following the :Hemodynamic Echocardiography Assessment in Real Time ( HEART) protocol. According to the clinical findings of TTE patients may be either free or have one or more of the following haemodynamic states normal, empty, vasodilated ,left ventricular systolic or diastolic failure, left ventricular systolic and diastolic failure, and right ventricular failure, valve stenosis or regurgitation of at least moderate severity
15841154|NCT04114461|Drug|HL-TOF tab. 5mg|HL-TOF
15841155|NCT04114461|Drug|Xeljanz tab. 5mg|Xeljanz
15841156|NCT04114448|Other|Therapeutic exercise|Patients will perform an exercise protocol specifically designed for patients with hemophilia that will include exercises focused on improving range of movement, strength, flexibility, balance and coordination as well as diaphragmatic breathing at the start and at the beginning of each session.
15841157|NCT04114448|Other|Usual physical therapy care|Patients will undergo usual physical therapy treatment for hemophiliacs, based on affected self and gentle joint mobilization and stretching of muscles involved in the affected joints.
15841158|NCT04114435|Other|Echocardiography|Diagnostic test which uses ultrasound waves to make images of the heart chambers, valves and surrounding structures
15841159|NCT04114422|Other|Seven-day preoperative exercise training program|The preoperative exercise training program will be supervised by a physiotherapist and will comprise aerobic exercise on a treadmill as well as strengthening exercises for the upper and lower limbs. The protocol will include 7 daily sessions of 60 minutes in duration. The treadmill exercise will start with a 5-minute warm-up and will progress to 30 minutes of exercise with a speed corresponding to 70% of the maximum speed reached in the incremental shuttle walk test. It will finish with a 5-minute cool down period. Participants will also perform three strengthening exercises for the lower limbs (hip flexion, knee flexion and extension) and three for the upper limbs (shoulder flexion, elbow flexion and extension). The initial strengthening exercises intensity will be set at 60% of 1RM and will be progressively increased. Patients will perform 3 sets of 8 to 12 repetitions for each exercise.
15841160|NCT04114396|Drug|Anti-IL5 Antibody|Asthma group: Anti-IL5 treatment Control group: No biologic.
15841161|NCT04114396|Procedure|Bronchoscopy|Optional for both arms
15841162|NCT04114383|Other|D3-Creatine|30mg D3-Creatine to measure muscle mass
15841163|NCT04114383|Other|Deuterium Oxide|D2O provided to measure muscle protein synthesis
15841164|NCT04114383|Other|D3-3-methylhistidine|D3-3-methylhistidine is provided to measure muscle protein breakdown
15841165|NCT04114370|Drug|18F-fluciclovine|Prior to beginning PET imaging, 18F-fluciclovine will be administered as an intravenous bolus injection followed by a 10mL saline flush. 18F-fluciclovine will be injected through a cannula (or indwelling catheter) in an antecubital vein or another vein that will provide access. The administration site will be evaluated pre- and post-administration for any reaction. Documentation of administration to a participant will be recorded or as part of the scan upload, including date, prescription number, dose activity (as measured at time of administration), total volume, and start/stop time of administration.
15841166|NCT04114357|Drug|Acetylated and Butyrylated High Amylose Maize Starch|Participants will be instructed to consume HAMS-AB in two divided doses at breakfast and dinner
15841167|NCT04114344|Procedure|TAPP|Trans Abdominal Pre Peritoneal approach
15841168|NCT04114344|Procedure|TEP|Total Extra Peritoneal approach
15841169|NCT04114331|Other|Manual therapy and exercise|Manual therapy consisting of soft tissue and joint mobilization to gain mobility. Therapeutic exercise was active motion and resisted motion to gain motor control and motor coordination in the new range.
15841170|NCT04114318|Other|Dual-task cognitive-cycling training|Cognitive and cycling training simultaneously for dual-task cognitive-cycling training; stationary bicycle exercise training for single-task cycling training
15841171|NCT04114305|Behavioral|ECD Intervention|"Modeled on the Early Learning Resource Unit's Family & Community Motivator home visiting program and Philani Mentor Mothers home visiting program in South Africa. Program provided stimulation in 5 domains: cognitive, receptive and expressive language, gross and fine motor skills, also covered topics in maternal and child health, nutrition and social services.
~Comprised primarily of home visits beginning during pregnancy and continuing until the child was 18 months. ECD MM taught the parent/caregiver about ages and stages of growth, helped facilitate responsive parenting and early learning opportunities for their children, demonstrated use of toys and books to stimulate the child, provided families with picture books, and taught caregivers to create toys and books for their child. Community parenting information play groups and educational talks on ECD at the clinic supplemented home visits."
15841172|NCT04114292|Drug|Tauroursoursodeoxycholic acid, brand name Tudcabil|Dosed in capsules containing 250 or 500mg of TUDCA for a total dose of 1.75-2g/day
15841173|NCT04114279|Procedure|Performance of laparoscopic duodenal atresia repair|completion of laparoscopic duodenal atresia repair in a surgical simulator
15841205|NCT04113967|Other|Biodanza program|Biodanza is a form of intervention aimed at promoting health and well-being through the promotion of self-expression and self-regulation through interaction through music and dance. The music accompanied by the movement of the body induces some experiences that present the ability to modify the organism itself both at an organic level, as affective-motor and existential. This intervention constitutes a means for the correct development of human qualities, whose purpose is to integrate the potentials of bond, health and harmony, as well as to develop new alternatives for the life of each individual.
15841206|NCT04113954|Drug|Mepivacaine Injection|Injection of 0.375% mepivacaine in nerve block
15841207|NCT04113954|Drug|Mepivacaine Injection|Injection of 1.5% mepivacaine in nerve block
15841208|NCT04113941|Drug|Neuronox|intradetrusor injection
15841209|NCT04113941|Drug|Placebo|intradetrusor injection
15841174|NCT04114266|Other|Questionnaires on Urinary Incontinence-, Sex Function- and Quality of Life (ICIQ-UI-SF, ICIQ-FLUTSsex, ICIQ-LUTSqol, PGI-I)|"Artificial Urinary Sphincter Surgery (Robot-assisted, Laparoscopic, Open, or other) for Female Stress Urinary Incontinence due to intrinsic sphincter deficiency is according to standard practice. Patients scheduled for this type of surgery will be asked to participate in this Registry.
~At baseline and follow-up, the patients will be required to fill in Questionnaires, i.e. ICIQ -Urinary Incontinence - Short Form (ICIQ-UI-SF), ICIQ Female Sexual Matters associated with Lower Urinary Tract Symptoms ( ICIQ-FLUTSsex), ICIQ Lower Urinary Tract Symptoms Quality of Life (ICIQ-LUTSqol), Patient Global Impression of Improvement-I (PGI-I) which are commonly used in daily practice to assess urinary incontinence, sexual function and quality of life. During the yearly visits, patients will not be required to come for a clinical visit as the questionnaires and a Follow-up form can be completed by post, e-mail or phone call."
15841175|NCT04114253|Diagnostic Test|Quantra System|Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
15841176|NCT04114240|Drug|Xybilun|Erectil dysfunction, Viagra generic (sildénafil)
15841177|NCT04114227|Behavioral|Acceptance and Commitment Therapy adapted for Cystic Fibrosis (ACT with CF)|Subjects learn new ways to manage uncomfortable experiences and feelings and to engage in positive behaviors
15841178|NCT04114227|Behavioral|Supportive Psychotherapy (Treatment as Usual Control)|Subjects talk about their experiences to date in a cohort of adult Cystic Fibrosis patients.
15841179|NCT04114201|Procedure|PSI|Implantation of a Total Knee Arthroplasty patient-specific instrumentation using Zimmer® NexGen Solutions (Zimmer Biomet, Warsaw, IN).
15841180|NCT04114201|Procedure|Conventional|Implantation of a Total Knee Arthroplasty with conventional using Zimmer® NexGen Solutions (Zimmer Biomet, Warsaw, IN).
15841181|NCT04114188|Drug|Antithymocyte Immunoglobulin (Rabbit)|1st kidney transplant recipients (low risk: PRA/cPRA < 20%, no DSA) will receive short rATG induction (2x1.5 mg/kg) given perioperatively and on first postoperative day. All patients will receive one shot Infliximab mAb at day 2. Since POD1, maintenance IS consists of Tac and tapered steroids therapy.
15841182|NCT04114175|Other|Exercise BE|Basic exercises related to amputation will be applied
15841183|NCT04114175|Other|Exercise BE+SS|Basic exercises related to amputation + Spinal stabilization exercises will be applied
15841184|NCT04114149|Device|TENS (transcutaneous electrical nerve stimulation)|TENS as first line of treatment. If insufficient pain relief, i.e. postoperative pain intensity according to NRS (numeric rating scale) ≥ 3 after two treatment sessions à 1 minute, the patient receives conventional treatment with iv opioids.
15841185|NCT04114149|Drug|iv opioid|Conventional treatment with iv opioid if postoperative pain intensity according to NRS (numeric rating scale) ≥ 3.
15841186|NCT04114136|Drug|Nivolumab or Pembrolizumab (dependent upon approved indication)|Anti-PD-1 mAb (monoclonal antibody)
15841187|NCT04114136|Drug|Metformin|Acts directly or indirectly on the liver to lower glucose production, and acts on the gut to increase glucose utilisation, increase GLP-1 and alter the microbiome.
15841188|NCT04114136|Drug|Rosiglitazone|A member of the thiazolidinedione class of antidiabetic agents, improves glycemic control by improving insulin sensitivity. Rosiglitazone is a highly selective and potent agonist for the peroxisome proliferator-activated receptor-gamma (PPARγ).
15841189|NCT04114110|Other|RTLS data|data extraction from RTLS
15841190|NCT04114097|Drug|Betnovate, betamethasone dipropionate ointment 0.1% and placebo|Explore the systemic effects of Betnovate
15841191|NCT04114097|Drug|Protopic, tacrolimus ointment 0.1%|Compare the systemic effects of Betnovate to Protopic
15841192|NCT04114084|Procedure|Bone Marrow Aspirate and Biopsy|The aspirate sample obtained for research at the time a standard-of-care biopsy is taking place will be approximately 40cc. Bone marrow aspiration removes bone marrow fluid and cells through a needle placed into the bone. Usually this sample is taken from the back of the pelvic bone, but it may also be taken from the sternum or the front of the pelvic bone. A bone marrow biopsy removes bone with the marrow inside and is done prior to the aspirate. Each biopsy and aspirate procedure takes approximately 15 minutes total. Bone marrow aspirate may be collected in a separate tube for research or collected from the standard-of-care specimen with left-over aspirate not otherwise needed for clinical purposes, or from previous procedures.
15841193|NCT04114071|Behavioral|TOSS Feasibility + Fitbit Community = Reduced Obesity in Older Black Women|See arm description
15841194|NCT04114058|Drug|liposomal bupivicaine|local field infiltration
15841195|NCT04114058|Procedure|Fascia iliaca blockade|fascia iliaca compartment blockade
15841196|NCT04114045|Dietary Supplement|Experimental:Whey protein|Each participant in the protein group received 2 protein drinks immediately following exercise. The supplement was given using a relative quantity of whey protein isolate (0.3g/kg) and was chocolate flavoured.
15841197|NCT04114045|Dietary Supplement|Active Comparator: Isoenergetic control - Carbohydrate|Each participant in the carbohydrate group received 2 drinks immediately following exercise. The supplement was given using a relative quantity of maltodextrin (0.3g/kg), non-caloric chocolate flavouring was added to mask the drinks contents.
15841198|NCT04114045|Other|Placebo|Each participant in the water group received 2 drinks immediately following exercise. The water was provided in a similar volume using the same non-caloric chocolate flavouring as the other drinks.
15841199|NCT04114019|Diagnostic Test|Vaginal tactile imager|Vaginal elasticity evaluation using a vaginal tactile imager
15841200|NCT04113993|Drug|Bazedoxifene Acetate|Oral Bazedoxifene dosed at 40 mg daily for 12 weeks
15841201|NCT04113993|Drug|Placebo|Identically packaged placebo capsule daily
15841202|NCT04113980|Other|music group|The children in the groups were distracted by music 2 minutes before venipuncture, until the process was over
15841203|NCT04113980|Other|kaleidoscope group|The children in the groups were distracted by kaleidoscope 2 minutes before venipuncture, until the process was over
15841204|NCT04113980|Other|video group|The children in the groups were distracted by watching video 2 minutes before venipuncture, until the process was over
15841210|NCT04113928|Dietary Supplement|Broccoli & mustard seed soup|200ml acute feed
15841211|NCT04113928|Dietary Supplement|Broccoli soup|200ml acute feed
15841212|NCT04113915|Drug|triple therapy|Effect of treatment on immunity to obtain infection with hepatitis B&C
15841213|NCT04113915|Drug|Steroids|Oral or parenteral steroid therapy for ITP
15841214|NCT04113902|Behavioral|Health Education|the adolescent girls and their mothers who participated in the intervention group were given health education twice in the first interview and in the fifth week. Follow-up continued for 12 weeks. The adolescent girls and their mothers in the control group received routine clinical practice. The effects of health education were evaluated with Human Papilloma Virus Knowledge Scale and Health Belief Model Scale for Human Papilloma Virus and its Vaccination.
15841215|NCT04113889|Drug|Metformin (1000 mg daily), Pioglitazone (30 mg daily), Acetyl-L-carnitine (3 gm daily)|72 patients with PCOS receiving metformin, pioglitazone and Acetyl L-Carnitine 500 mg, 15 mg and 1.5 gm BD daily respectively.
15841216|NCT04113889|Drug|Metformin, pioglitazone and placebo|72 patients with PCOS receiving metformin, pioglitazone and placebo 500 mg, 15 mg and placebo BD daily respectively.
15841217|NCT04113863|Drug|all-trans retinoic acid|Vesanoid will be supplied orally at the total dosage of 45mg/m2/d (two daily administrations of 22.5 mg/m2 each). Treatment will last 28 days
15841218|NCT04113863|Drug|Anastrozole 1mg|Anastrozole will be administered orally at the dosage of 1 mg/die.
15841219|NCT04113850|Device|Mobile Acoustic startle Reflex monitoring System (MARS)|Acoustic startle testing
15841220|NCT04113837|Dietary Supplement|food range|"The food range is comprised of:
~sausages (1100 g per week) eggs (3 eggs per week), 100 g mushrooms per day, one bread per week, bread rolls, 100 ml ice cream per week, 3x 70 g pasta per week"
15841221|NCT04113824|Procedure|trapezuis motion style acupuncture treatment|Motion Style Acupuncture Treatment(MSAT) is a therapeutic technique using acupuncture needle created in Jaseng Hospital. This treatment involves patients with musculoskeletal pain to move the part of their body actively during acupuncture treatment under physicians' observation
15841222|NCT04113824|Procedure|other Korean medical treatment|acupuncture treatment, chuna, pharmacoacupuncture, Korean herbal medicine
15841223|NCT04113811|Device|Biomedical TATO3® Microwave needle thermoablation device (Koelis, Grenoble, France)|In this study, we plan to investigate oncological outcome of fusion-guided microwave needle therapy using transperineal (TP) approach
15841224|NCT04113798|Other|Day 1 Assessments|Structured clinical interview to assess trauma history and mental health diagnoses, as well as a screening EKG to assess safety to engage in exercise testing (lasts 3-4 hours)
15841225|NCT04113798|Other|Day 2 Fear Learning|Participants undergo a standard fear conditioning procedure, in which they learn that one of two geometric shapes (circles or triangles) predict the occurrence of a noxious stimulus (mild electrotactile stimulation). Day 2 lasts about 1 hour.
15841226|NCT04113798|Other|Day 3 Fear Extinction|Participants undergo a fear extinction procedure, in which participants learn that the geometric shapes no longer predict a noxious stimulus (i.e., safety learning). Blood samples will be drawn immediately before exercise, and immediately following.
15841227|NCT04113798|Behavioral|Moderate Intensity Exercise|The moderate-intensity aerobic exercise session will consist of a 5 minute warm-up of light intensity activity (40-60% maximum heart rate; MHR) on a treadmill followed by walking or running at a moderate intensity (i.e., between 70-75% MHR) for 30 minutes on Day 3
15841228|NCT04113798|Behavioral|Low Intensity Exercise|Control participants will maintain light-intensity activity (i.e., walking at ~50% of MHR) for the full duration of 30 minutes.
15841229|NCT04113798|Other|Day 4 Recall of Fear Extinction|During Day 4, recall of the fear extinction memory is tested. Visits on Day 4 occur ~24 hours following Day 3, and lasts about 30 minutes.
15841230|NCT04113785|Device|Klassic Knee System|At present, all TKA available for surgeons to use are asymmetric where there is a distinct femoral and tibial component for the left knee and a distinct femoral and tibial component for the right knee. The Klassic knee system is a symmetrical knee implant, where the same femoral and same tibial component can be used for either the right or left knee
15841231|NCT04113772|Drug|Nitisinone|Measure bio equivalency/efficacy of nitinosine and orfadin
15841232|NCT04113772|Drug|Orfadin|Orfadin
15841237|NCT04113733|Other|Sample Collection|Tissue biopsies will be performed at the time of colonoscopy along with blood and stool sample collection.
15841238|NCT04113720|Drug|Levobupivacaine hydrochloride|levobupivacaine 0.25%
15841239|NCT04113720|Drug|Levobupivacaine Hydrochloride + Dexmedetomidine|Levobupivacaine plus Dexmedetomidine
15841240|NCT04113707|Behavioral|Motor lab activity|fitness, gross motor, fine motor, and motor coordination activities
15841241|NCT04113694|Device|Extended Infusion Set|Each subject is asked to wear each Extended Wear Infusion Set for at least 174 hours.
15841269|NCT04113447|Other|observational|observational
15841270|NCT04113421|Diagnostic Test|Contrast-enhanced chest CT|A single follow-up contrast-enhanced chest CT to compare off-line with the contrast-enhanced chest CT done at baseline for the diagnosis of PE.
15841271|NCT04113408|Other|FABIR sequence|The FABIR sequence with a duration of 8 minutes is added to the imaging protocol.
15841272|NCT04113395|Other|sequences T1 FE|T1 TSE and T1 TFE sequences with a duration of 6 minutes are added to the imaging protocol.
15841306|NCT04113135|Other|Control|Participants in this group will receive education related to MS as well as SMART goal setting, journaling, and guided meditation.
15841242|NCT04113681|Procedure|Geniculate Artery Embolization|"Conscious sedation : midazolam and fentanyl
~Local anesthesia : Lidocaine 2% subcutaneous
~Retrograde or anterograde common femoral artery access - 4Fr introducer
~Sub-therapeutic anticoagulation (heparin 2000 IU IA)
~Lower extremity arteriography
~Selective and supra-selective catheterization of geniculate arteries supplying painful region of the knee
~If abnormal arterial blushes are demonstrated selective and supra-selective embolization will be performed with Embozene microspheres (100 microns to 200 microns) - cold saline or ice-packs sac to be applied to overlying skin if significant cutaneous arteries are demonstrated at angiography.
~Angiographic end-points: embolization of abnormal blush while preserving the parent vessel
~Arteriotomy closure (manual compression or closure device)"
15841243|NCT04113668|Drug|BMS-986165|Specified Dose on Specified Days
15841244|NCT04113668|Drug|diflunisal|Specified Dose on Specified Days
15841245|NCT04113655|Biological|Pertagen (aP BioNet)|"Pertagen (aP BioNet) was produced with a recombinant B pertussis strain that was genetically inactivated by the introduction of mutations (Arg9Lys and Glu129Gly) in the ptx operon of the S1 gene. Each 0.5 mL dose of Pertagen (aP BioNet) contained 5 µg PTgen, 5 µg FHA, and 0.3 mg as aluminium cation.
~The study vaccine was presented in a single-dose prefilled syringe. Each subject was received one intramuscular injection in the non-dominant deltoid region in parent protocol TDA202."
15841246|NCT04113655|Biological|Boostagen (TdaP BioNet)|"Boostagen (TdaP BioNet) was produced with a recombinant B pertussis strain that was genetically inactivated by the introduction of mutations (Arg9Lys and Glu129Gly) in the ptx operon of the S1 gene. Each 0.5 mL dose of Boostagen (TdaP BioNet) contained 5 µg PTgen, 5 µg FHA, and 0.3 mg as aluminium cation. TDaP dose additional contained at least 7.5 Lf tetanus toxoid and at least 2.0 Lf diphtheria toxoid.
~The study vaccine was presented in a single-dose prefilled syringe. Each subject was received one intramuscular injection in the non-dominant deltoid region in parent protocol TDA202."
15841247|NCT04113655|Biological|Adacel|"Comparator vaccine, Adacel (Sanofi-Pasteur, North York, ON, Canada) was produced chemically inactivated pertussis toxin. Each 0.5 mL dose of Adacel (as comparator vaccine) contained 2.5 µg PTchem, 5 µg FHA, 3 µg pertactin, 5 µg fimbriae types 2 and 3, 5.0 Lf tetanus toxoid, 2.0 Lf diphtheria toxoid and 0.33 mg as aluminium cation.
~The study vaccine was presented in a single-dose prefilled syringe. Each subject was received one intramuscular injection in the non-dominant deltoid region in parent protocol TDA202"
15841248|NCT04113642|Other|ultrasonographic measurement of abdominal muscle thickness at four positions|Thickness of transversus abdominis, internal oblique and external oblique muscles were evaluated using ultrasound at rest and during abdominal hollowing, bridge, and bridge with isometric arm extension.
15841249|NCT04113629|Device|HCV point of care machine|Xpert HCV Assay performed on the GeneXpert point of care machine
15841250|NCT04113616|Drug|KRT-232|KRT-232 is an experimental MDM2 inhibitor anti-cancer drug taken by mouth.
15841251|NCT04113616|Drug|Cytarabine|Cytarabine is an anti-cancer chemotherapy drug taken via injection.
15841252|NCT04113616|Drug|Decitabine|Decitabine is an anti-cancer chemotherapy drug taken via injection.
15841253|NCT04113603|Diagnostic Test|Urinary malignancy|Single bolus three phase CTU
15841254|NCT04113590|Procedure|Laparoscopic Assisted Transvaginal Cholecystectomy|Perform transvaginal cholecystectomy while obtaining safe access under laparoscopic visualization
15841255|NCT04113577|Other|usability survey|usability survey composed of subpart: System Usability Scale, questions about global ergonomics of the app, questions about eronomics of the exerecices, question about global satisfaction.
15841256|NCT04113564|Drug|Remimazolam|
15841257|NCT04113551|Drug|MPH (Concerta)|MPH (Concerta) is approved for the indications of ADHD and Narcolepsy in Japan. This is a non-interventional study and no drug will be given as part of this study. Analysis will be performed from data taken from Japan medical data center (JDMC) database.
15841258|NCT04113551|Drug|MPH (Ritalin)|MPH (Ritalin) is approved for the indication of ADHD in Japan. This is a non-interventional study and no drug will be given as part of this study. Analysis will be performed from data taken from JDMC database.
15841259|NCT04113551|Drug|Atomoxetine (ATO)|Atomoxetine (ATO) is approved for the indication of ADHD in Japan. This is a non-interventional study and no drug will be given as part of this study. Analysis will be performed from data taken from JDMC database.
15841260|NCT04113551|Drug|Guanfacine (GFC)|Guanfacine (GFC) is approved for the indication of ADHD in Japan. This is a non-interventional study and no drug will be given as part of this study. Analysis will be performed from data taken from JDMC database.
15841261|NCT04113538|Drug|Aflibercept|Intraocular injection of 2 ml (40mg/ml)
15841262|NCT04113525|Device|MyoRegulator™ System|Paired transcutaneous spinal and peripheral nerve stimulation
15841263|NCT04113512|Other|Jalaneti|Sterilised and lukewarm isotonic salt water using neti pot was poured into one nostril, so that it leaves through the other. The procedure is then repeated on the other side, and the nose is dried by bending forward and by rapid yoga breathing
15841264|NCT04113499|Procedure|Direct Endoscopic Intervention|"The necrotic collection is first identified using a linear echoendoscope. A Hot AXIOS stent is utilized in all patients for EUS-guided drainage of the necrotic collection. The necrotic material is sent for gram stain and culture with sensitivities.
~For endoscopic necrosectomy, in patients allocated to direct endoscopic necrosectomy group, endoscopic necrosectomy is performed during the same session as the index endoscopic drainage. It is performed using a therapeutic gastroscope and various accessories (see below for further details) for 90 to 120 minutes."
15841265|NCT04113499|Procedure|Step-up Endoscopic Intervention|"The necrotic collection is first identified using a linear echoendoscope. A Hot AXIOS stent is utilized in all patients for EUS-guided drainage of the necrotic collection. The necrotic material is sent for gram stain and culture with sensitivities.
~In patients allocated to the step-up endoscopic interventions group, endoscopic necrosectomy is not performed at the time of the index intervention, however it is performed when clinically indicated during the follow-up period (6 months from index intervention)."
15841266|NCT04113486|Other|Blood test|About 4 ml of blood draw
15841267|NCT04113473|Other|Yoga Therapy|"An hour of yoga therapy included loosening exercise (sukshma vyayama), yoga postures (asana), yoga breathing (pranayama), relaxation (shavasana) and meditation.
~Each participant were given handouts to follow home practice sessions everyday for twice a day for at least 15 minutes."
15841268|NCT04113460|Other|Yoga|Yoga@work program included physical movements, yoga posture, breathing exercise, pranayama and yoga chants. Session with trainer was conducted on worksite once a week for an hour.
15841275|NCT04113369|Device|TENS|30 minutes of conventional antalgic TENS to non-paretic forearm
15841276|NCT04113369|Procedure|Conventional rehabilitation|40 minutes of lower limb training and 20 minutes of upper extremity training for stroke
15841277|NCT04113369|Device|EMS|20 minutes of EMS to non-paretic forearm with 5 minutes of pre and post warm-up
15841278|NCT04113356|Diagnostic Test|Cardiovascular Magnetic Resonance Imaging|Cardiovascular magnetic resonance imaging will be performed within the first week after ST-elevation myocardial infarction and in a defined subgroup 4 months, 12 months and 10 years thereafter.
15841279|NCT04113343|Drug|Remimazolam|Remimazolam via oral administration
15841280|NCT04113343|Other|Alcohol|Alcohol
15841281|NCT04113317|Drug|G-CSF (Filgrastim)|Contains 0,59 mg of acetate, 0,04 mg of polysorbate 80, 0,035 mg of sodium, 50 mg of sorbitol
15841282|NCT04113304|Behavioral|Parenting Young Children Check-up (PYCC)|The PYCC intends to motivate parents to learn behavioral parenting strategies to reduce child disruptive behavior.
15841283|NCT04113291|Other|DASH Diet|12 Weeks of isocaloric DASH diet <2300 mg Na/day using meals (lunch, dinner, snacks) prepared by the Wake Forest Clinical Research Metabolic Kitchen under the direction of a registered dietician (RD). Participants will prepare their own breakfast from a menu.The subjects will be instructed to drink no more than three caffeinated beverages and no more than two alcoholic beverages per day.
15841284|NCT04113291|Other|Usual diet|12 weeks usual diet <2300 mg Na/day
15841285|NCT04113278|Genetic|FGL2 immunohisyochemistry|Correlation between FLG2 expression and progression free survival and overall surviv
15841286|NCT04113265|Device|SUNEKOS ® Body|SUNEKOS ® Body is a medical device (class III). The study product was injected at level of the inner thighs, knees and arms by needle (29 G) using the interstitial fluid technique (IFT)
15841287|NCT04113252|Other|Possible Incentive for Tablet Return|Subjects who return completed diary will have the possibility to receive money for returned opioid tablets.
15841288|NCT04113252|Other|Incentive for Completed Diary|Subjects who return completed diary will receive a gift card.
15841289|NCT04113252|Behavioral|Coaching|Subjects will receive coaching prior to starting pain medication.
15841290|NCT04113239|Diagnostic Test|16S rRNA gene sequencing|Taking a stool sample for gut microbiome DNA sequencing
15841291|NCT04113239|Genetic|DNA-microarray genotyping|Taking a saliva sample for genotyping
15841292|NCT04113226|Drug|Rituximab|patients ≥ 75 years old with relapsed Diffuse large B-cell lymphoma will be treated with classical Rituximab-based chemotherapy or Rituximab plus Lenalidomide.
15841293|NCT04113226|Drug|Lenalidomide 20 MG|patients ≥ 75 years old with relapsed Diffuse large B-cell lymphoma will be treated with Rituximab plus Lenalidomide. Four 28-days cycles of oral Lenalidomide (20 mg / d for 21 days) and Rituximab 375mg/m2 on day 1 and day 21. After this induction phase, patients achieving at least stable disease were given lenalidomide maintenance therapy (20 mg for 21 days) until progression
15841294|NCT04113226|Other|Comprehensive Geriatric Assessment (CGA)|A comprehensive geriatric assessment (CGA) is recommended by the Société Internationale d'Onco Gériatrie (SIOG) in order to assess all geriatric facets (comorbidity, functional impairment, nutritional status, mental and psychological status, environment,…) on which treatment may impact.
15841295|NCT04113226|Other|Activities of daily living (ADL) scale|Activities of daily living (ADL) comprise the basic actions that involve caring for one's self and body, including personal care, mobility, and eating. The Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. Clients are scored yes/no for independence in each of the six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.
15841296|NCT04113213|Behavioral|Lifestyle Prescription (LRx)|Lifestyle prescription, based on the UK WP10 medicinal prescription form. Includes advice and guidance regarding physical activity, diet, smoking and alcohol consumption.
15841297|NCT04113200|Dietary Supplement|MerMed One|A 1 kcal per ml enteral feed containing an alginate.
15841298|NCT04113200|Dietary Supplement|Nutricomp Soy Fibre|A 1kcal per ml enteral feed not containing alginate.
15841299|NCT04113187|Drug|Propranolol treatment|40 mg twice a day (morning and evening), per os, during three months
15841300|NCT04113187|Drug|Placebo|per os, twice a day (morning and evening) during three months
15841301|NCT04113174|Other|Decision Analytic Modelling|Prognostic models will be translated into a framework to guide clinical decision making by identifying relevant thresholds of predicted risk, above which implementation of our stated interventions is warranted.
15841302|NCT04113161|Other|Standard Care|Standard care will consist of 1) community-based screening and referral conducted by HomeGrown St. Louis (HomeGrown StL) network members and supported by HomeGrown StL coordinator; and 2) monthly contacts by a case manager, who will track attendance in mental health services and provide referrals upon request.
15841303|NCT04113161|Other|Child Behavioral Health Navigator (cbhN)|CbhNs will engage in a series of contacts in person and by phone/text to coordinate needed appointments at mental health care sites, as well as a range of human service support organizations (e.g. housing, food, financial, legal assistance). Over time, contact may decrease as the youth/family make ongoing connection with mental health care and other resources. However, over the course of the study (twelve months), twice per month check-ins will be routine between cbhNs and families. In addition, the cbhN will be expected to actively engage with the range of service providers and mental health resources as needed and preferred by the family. These contacts include telephone linkage calls, in-person advocacy meetings and at time, accompanying the youth and families to meetings at each organization.
15841304|NCT04113148|Other|Physiological measurements from heel|Measurements of blood flow, tissue oxygen saturation, temperature, pressure
15841305|NCT04113135|Other|Yoga|Participants will be lead through a series of yoga poses by a licensed physical therapist with advanced training in yoga. Participants in this group will also receive education related to MS as well as SMART goal setting, journaling and guided meditation. Modifications will be offered as needed.
15841307|NCT04113122|Diagnostic Test|Skin biopsy|A 4 mm skin biopsy will be performed at the upper leg of the patient. Before the skin biopsy local anesthesia is applied subcutaneously. In these skin biopsies senescent cells will be detected by p16, p21 and yH2Ax staining. Furthermore, we will measure platinum levels in the skin biopsies.
15841308|NCT04113122|Diagnostic Test|Subcutaneous fat biopsy|"An abdominal subcutaneous fat biopsy will be performed 7-10 cm on the right side of the umbilicus. Before the fat biopsy local anesthesia is applied subcutaneously. An amount of 30 mg fat tissue will be collected using needle aspiration.
~In these fat biopsies senescent cells will be detected by p16, p21 and yH2Ax staining. Furthermore, we will measure platinum levels (ICP-MS), adipocytokines (leptin, adiponectin, interleukin-6, PAI-1, TNF-α), p53 activation indirectly by measuring p21 or mdm2 expression using immunohistochemistry, microRNA regulation of insulin signaling in adipose tissue: miR-103, miR-107, miR-29."
15841309|NCT04113109|Drug|LCZ 696|Treatment with LCZ696 is unblinded in this study. After the two acute study days, subjects will be provided LCZ696 50 mg bid for two weeks. At the end of those two weeks subjects will report to the Clinical Research Center (CRC) for a dose escalation visit. If their tolerance, blood pressure, potassium, and eGFR meet escalation criteria they will be given LCZ696 100 mg bid for three weeks. (If they do not meet escalation criteria they will be continued on LCZ696 50 mg bid.) After three weeks, they will return to the CRC for the next escalation visit. If they meet criteria for escalation they will be given LCZ 200 mg bid for ten days. (If they do not meet escalation criteria they will be continued on the highest tolerated dose).
15841310|NCT04113109|Drug|Icatibant|Icatibant will be given intravenously at 100 µg/kg over one hour followed by 20 µg/kg/hr during each study day.
15841311|NCT04113109|Drug|placebo|Placebo (vehicle) will be given at the same rate as icatibant.
15841312|NCT04113109|Drug|Para-aminohippurate|Para-aminohippurate (PAH) will be given at a dose of 8 mg/kg loading dose followed by a 12 mg/min steady-state infusion during each study day.
15841313|NCT04113109|Drug|Iohexol|Iohexol will be given as 5 mL of iohexol solution (3.235 g iohexol) intravenously on each study day.
15841314|NCT04113096|Drug|Dibenzyl trisulphide capsules|20 mg once daily for 6 months
15841315|NCT04113096|Drug|Dibenzyl trisulphide capsules|20 mg once daily for 6 months
15841316|NCT04113096|Drug|Dibenzyl trisulphide capsules|20 mg once daily for 6 months
15841317|NCT04113096|Drug|Dibenzyl trisulphide capsules|20 mg once daily for 6 months
15841318|NCT04113096|Drug|Stage IV Breast Cancer Placebo|20 mg once daily for 6 months
15841319|NCT04113096|Drug|Stage IV: Colon Cancer Placebo|20 mg once daily for 6 months
15841320|NCT04113096|Drug|Cervical Cancer Stage IV Placebo|20 mg once daily for 6 months
15841321|NCT04113096|Drug|Cancer of the Prostate Placebo|20 mg once daily for 6 months
15841322|NCT04113083|Other|Blood sampling for cholestanol analysis|Blood sampling will be performed by Düzen Laboratories group for cholestanol
15841323|NCT04113070|Device|Anthropometric measuring|To divide participants into overweight and obesity and non-overweight group according to their weight status, height (H), weight (W) and waist circumference (WC) will be measured with a uniform tool, which has been calibrated. When measuring the height, the subjects are required to take off their shoes and stand in an upright position. To measuring weight, the subjects are required to wear close-fitting clothes and bare feet. Subjects are required to take the standing position to measure waist circumference horizontally at the mid-point of line between the lower margin of the ribs and the upper margin of the ilium. All those data will be kept one decimal place. Anthropometric measuring will be taken at baseline and follow-up periods.
15841324|NCT04113070|Other|Growth environment evaluation|The information of children' growth environment, including family environment, physical activities, dietary and sleep habits, will be collected by parent-report questionnaire at baseline and follow-up periods.
15841325|NCT04113057|Other|Remote Coaching|In patients randomized to the remote coaching arm, study staff will provide feedback on home-based supplemental exercise based on heart rate and walking distance measurements from the LIVMOR health monitoring system.
15841326|NCT04113044|Other|All treatments will remain the standard (routine) care procedures based on individual clinician's judgment and the patient characteristics.|All treatments will remain the standard (routine) care procedures based on individual clinician's judgment and the patient characteristics.
15841327|NCT04113031|Behavioral|Flywheel squats versus free weight high load squats for explosive actions in football|Over the course of the interventions, all players in all three groups will be instructed to adhere to their two-three weekly football practices and preseason matches of their team (~one weekly match). The flywheel group performes squat resistance exercise in using a flywheel device, and the barbell free weight group performes squat resistance exercise using an Olympic barbell and weights.
15841328|NCT04113018|Drug|Carfilzomib, lenalidomide, dexamethasone (KRd) + Daratumumab|Experimental
15841329|NCT04113005|Drug|Desmopressin|To evaluate the safety and tolerability of Desmopressin in CRPC subjects starting Docetaxel treatment. Additionally, CTCs will be collected before and after Desmopressin/Docetaxel treatment to evaluate therapeutic efficacy.
15841330|NCT04112992|Procedure|Any treatment that is used for a defect of any long bone|Any treatment that is used for a defect of any long bone. All treatments are based on individual clinician's judgement and the patient characteristics. The registry does not dictate any specific treatment.
15841331|NCT04112979|Behavioral|Music|45 dB SL, normalized, high-frequency sampled W.A. Mozart Symphony n°4 in D K19 and n°5 in B-flat K22 (from Mozart Symphonies Vol. I - Adam Fisher, Dacapo Records, Frederiksberg C., Denmark, 2013)
15841332|NCT04112979|Behavioral|Mother's lap|45 dB SL, normalized and filtered, high-frequency sampled heartbeat sound, 75 bpm tempo, looped
15841333|NCT04112979|Behavioral|Soundproof earplugs|Disposable foam earplugs with a noise attenuation of at least 30 dB
15841334|NCT04112966|Procedure|14 sessions of manual lymphatic drainage technique|Early manual lymph drainage including 14 sessions of manual lymphatic drainage technique in the three months following surgery and health education for lymphedema prevention including verbal instructions and written materials.
15841335|NCT04112966|Other|the health education|The health education for lymphedema prevention.
15841336|NCT04112940|Other|Starch-based Thickened Liquids|Barium will be thickened to slightly, mildly, moderately and extremely thick consistences as defined by the International Dysphagia Diet Standardisation Initiative flow test.
15842318|NCT04104984|Drug|Tocolytic Agents|a medication is given to prevent uterine contraction
15841337|NCT04112940|Other|Xanthan-gum Thickened Liquids|Barium will be thickened to slightly, mildly, moderately and extremely thick consistences as defined by the International Dysphagia Diet Standardisation Initiative flow test.
15841338|NCT04112914|Behavioral|Post-concussion education for families|An educational resource for families will be developed based on the CDC guidelines for returning to daily activities, school, and sports, adapted with stakeholder feedback to meet the learning needs of low health literacy parents. An implementation toolkit will be developed, adapting the AHRQ RED Toolkit, to support communication about the educational resource and other best-practices for communication with families, including low health literacy families.
15841339|NCT04112901|Device|Microprocessor-controlled knee joints|Any type of microprocessor-controlled knee joints will be considered; this includes those controlling stance phase only (e.g. Compact C-Leg), swing phase only (e.g. Smart IP), both swing and stance phases (e.g. Reho knee), or power generating knees (e.g. POWER knee Ossur).
15841340|NCT04112901|Device|Non-microprocessor-controlled knee joints|Any non-microprocessor-controlled knee joints such as prosthesis incorporating hydraulic, polycentric, pneumatic mechanisms, friction or locked knees.
15841341|NCT04112888|Combination Product|Collagen|Patients will receive 3 to 5 collagen infiltrations in the scar once per week. Patients with episiotomy will receive 3 collagen infiltrations while patients who underwent a cesarean section will receive 5 collagen infiltrations. The infiltration will be done by tunneling technique, that is, it will be applied along the scar, placing the needle almost tangential to the entire length of the area, then it will be injected and at the same time the needle will be removed. Infiltrations will be carried out intradermally, previously performing asepsis in the area to be infiltrated. 2 ml syringes will be used to infiltrate the episiotomy scars (we will use 1 vial of 2 ml ) and 5 ml for cesarean scars (2 vials of 2 ml ) and sterile needles of 30G, 13mm.
15841342|NCT04112888|Procedure|Rehabilitation sessions|Patients will receive the conventional treatment of 8 rehabilitation sessions with massage therapy techniques, muscle stretches and fascial work. The rehabilitation sessions will always be carried out by the same physiotherapist specialized in pelvic floor. There will be two sessions per week for four weeks. The sessions will last 45 minutes.
15841343|NCT04112875|Dietary Supplement|L-arginine|Handled powdered supplement to be mixed with water, has orange flavor for oral use.
15841344|NCT04112875|Dietary Supplement|Maltodextrin|hydrolysis of cornstarch or starch as a white powder to be mixed with water, has orange flavor for oral use.
15841345|NCT04112862|Other|sodiumlactate|intravenous sodiumlactate 600mmol/L
15841346|NCT04112849|Diagnostic Test|Measurement of S3 heart sound|S3 heart sound to be measured by Nanowear Congestive Heart Failure Management System device.
15841347|NCT04112823|Drug|Dexamethasone 4mg|Dexamethasone 4mg + metoclopramide 10mg, intravenously
15841348|NCT04112823|Drug|Dexamethasone 16mg|Dexamethasone 16mg + metoclopramide 10mg, intravenously
15841349|NCT04112810|Drug|Tildrakizumab|100 mg will be injected subcutaneously on Day -1, Day 28 ± 3, Day 112 ± 7, Day 196 ± 14, and Day 280 ± 14.
15841351|NCT04112771|Drug|Penehyclidine hydrochloride|Penehyclidine hydrochloride was administered before anesthesia induction.
15841352|NCT04112771|Other|No penehyclidine hydrochloride|Penehyclidine hydrochloride was not administered before anesthesia induction.
15841353|NCT04112758|Other|High-intensity interval training|2 times weekly for 5 weeks Circuit training with 4 stations
15841354|NCT04112745|Other|Static magnet|Static magnet with 2,000 Gauss
15841355|NCT04112745|Other|Placebo|Polyvinyl chloride resin material black jewelry
15841356|NCT04112732|Dietary Supplement|Multivitamin|Multivitamin
15841357|NCT04112732|Other|Placebo|Placebo
15841358|NCT04112719|Other|supine position|The patient will be placed in a supine position. Changes in cardiac output will be measured.
15841359|NCT04112719|Other|15 degrees lateral tilt|The patient will be placed in 15 degrees lateral tilt position. Changes in cardiac output will be measured.
15841360|NCT04112719|Other|30 degrees lateral tilt|The patient will be placed in 30 degrees lateral tilt position. Changes in cardiac output will be measured.
15841361|NCT04112706|Drug|CPP-ACP|CPP-ACP WAS APPLIED AFTER TOOTH BLEACHING
15841362|NCT04112693|Procedure|Esophageal biopsies during Peroral Endoscopic Myotomy (POEM)|"In total, 14 biopsies are performed with a pediatric biopsy forceps belonging to the study center: 3 biopsies at 3-6 cm above cardia, contralaterally from POEM, of which 2 are placed in nitrogen and 1 in formol for histopathological analysis; 3 biopsies at the cardia, contralaterally from POEM, of which 2 are placed in nitrogen and 1 in formol for histopathological analysis; 4 biopsies of the muscularis propria (exposed during POEM) at 3-6 cm above cardia, of which 3 are placed in nitrogen and 1 in formol for histopathological analysis; 4 biopsies of the muscularis propria at the cardia, of which 3 are placed in nitrogen and 1 in formol for histopathological analysis; The biopsies intended for histopathological analysis will be analyzed in FFOCT before histopathological analysis. The FFOCT analysis take place for the patient inclued after than 10 november 2020.
~The biopsies are taken by the gastroenterologist who performs the POEM and is assisted by an endoscopy-specialized nurse."
15841363|NCT04112680|Behavioral|Debunking Misinformation through Audio Dramas|The audio dramas (one drama of 4 episodes per intervention group), aim to debunk misinformation about an infectious disease. The content of the two dramas differ in the two groups; in intervention group 1, the drama will state the misinformation and provide a plausible alternative, delivered through a trusted source, in line with world views. In intervention group 2, the audio drama will avoid mentioning the misinformation and instead only state the correct information about the infectious disease
15841364|NCT04112680|Behavioral|Control group audio jingles|The control group will receive audio jingles about exclusive breastfeeding
15841365|NCT04112667|Other|Normal Macular Health|This group of participants will have function assessed using rod- and cone-mediated tests (rod-mediated dark adaptation, 2 color dark adapted perimetry, cone-mediated perimetry, photopic and mesopic acuity, photopic and mesopic contrast sensitivity). Age-related macular degeneration status will be determined by multi-modal imaging.
15841366|NCT04112667|Other|Early Macular Degeneration|This group of participants will have function assessed using rod- and cone-mediated tests (rod-mediated dark adaptation, 2 color dark adapted perimetry, cone-mediated perimetry, photopic and mesopic acuity, photopic and mesopic contrast sensitivity). Age-related macular degeneration status will be determined by multi-modal imaging.
15841367|NCT04112667|Other|Young Normals|This group of participants will have function assessed using rod- and cone-mediated tests (rod-mediated dark adaptation, 2 color dark adapted perimetry, cone-mediated perimetry, photopic and mesopic acuity, photopic and mesopic contrast sensitivity). Age-related macular degeneration status will be determined by multi-modal imaging.
15841368|NCT04112654|Procedure|Conventional pressure laparoscopy|Conventional pressure laparoscopy using conventional insufflator AirSeal®
15841369|NCT04112654|Procedure|Low pressure laparoscopy|Low pressure laparoscopy using pressure-controlled insufflator AirSeal®
15841370|NCT04112641|Drug|Nicotinamide riboside|Daily oral ingestion of 1 g/day NIAGEN in capsule form for 84 days; two capsules in the a.m. and two capsules in the p.m.
15841371|NCT04112641|Drug|Placebo capsules|Daily oral ingestion of placebo in capsule form for 84 days; two capsules in the a.m. and two capsules in the p.m.
15841372|NCT04112615|Device|Blood measurement|Single fingerprick to measure haemoglobin and haematocrit measurements using a potential haemoglobin home monitoring system.
15841373|NCT04112602|Other|Sputum|Sputum will be collected after a respiratory physiotherapy session, scheduled as part of routine care.
15841374|NCT04112602|Other|Tracheal aspiration|Tracheal aspirations will be collected in intubated patients (intubation for surgery under general anesthesia).
15841375|NCT04112589|Drug|Quizartinib|Quizartinib at different doses in the phase I (40mg-14 days; 60mg-14 days; 60mg-7days, 40mg-7days). RP2D in the phase II part.
15841376|NCT04112589|Drug|Fludarabine|30 mg/m2 intravenous days 1 to 4 of the cycle
15841377|NCT04112589|Drug|Cytarabine|2 g/m 2 intravenous days 1 to 4 (1 g/m2 in patients older than 59) of the cycle
15841378|NCT04112589|Drug|Idarubicin|10 mg/ 2 intravenous days 1 to 3 of the cycle
15841379|NCT04112589|Drug|glycosylated G-CSF|daily dose of 300 mcg/m 2 , from day -1 until day 5 of the cycle
15841380|NCT04112576|Device|Wearable cardiac monitor|Participants will be fitted with a wearable cardiac monitor placed on the skin that measures physiologic signals.
15841381|NCT04112563|Procedure|exploration in white light (WLI)|Exploration of the right colon done in white light (WLI)
15841382|NCT04112563|Procedure|Exploration in LCI|Exploration of the right colon in linked color imaging (LCI)
15841383|NCT04112550|Drug|Methadone Hydrochloride|FDA approved medication to treat pain
15841384|NCT04112550|Drug|Oxycodone-Acetaminophen|FDA approved medication to treat pain
15841385|NCT04112524|Device|App|"Alleye® Test Alleye® Test is a mobile medical software application indicated for the detection and characterization of metamorphopsia. For the mean Alleye score (±standard deviation (SD) deviations of dots from an ideal line are calculated for each eye.
~AMD-A Metamorphopsia Detector® Is based on the Amsler grid. The software uses the concept of a negative image: a distorted image can be straightened by moving the mouse. Degree and dimension of distorted lines or scotoma are transformed into indices."
15841386|NCT04112498|Drug|relatlimab|Specified dose on Specified days
15841387|NCT04112498|Drug|nivolumab|Specified dose on Specified days
15841388|NCT04112498|Drug|rHuPH20|Specified dose on Specified days
15841389|NCT04112485|Procedure|Microdiscectomy|
15841390|NCT04112472|Device|EYESTAR 900|EYESTAR 900 is an optical biometry device used to create a geometrical representation of the eye by means of optical interferometry. The intervention are optical, non-contact examinations with the investigational device EYESTAR 900 and comparative device(s). Results of the examinations serve to compare the performance data of the investigational device with those of the comparative devices.
15841391|NCT04112459|Other|prolonged mechanical ventilation|No intervention will be applied in this study
15841392|NCT04112446|Drug|Saroglitazar magnesium|On Day 1, subjects will receive a single oral dose of [14C]-saroglitazar magnesium
15841393|NCT04112433|Device|PURE EP 2|Enrolled patients receiving cardiac ablation treatment using the current standard of care with additional monitoring and intracardiac electrogram signal collection via the PURE EP 2 system.
15841394|NCT04112420|Diagnostic Test|Trans-esophageal echocardiography|"The department registers an unplanned admission of a patient to the intensive care unit. The indication is verified again by the intensive care physician.
~In this case, the patient is then admitted to the intensive care unit, supervised by an intensive care physician, orientated and initiated therapeutic and diagnostic measures.
~As part of the planned transthoracic cardiac ultrasound examination, it is then selected whether the patient is suitable according to the patient's will and the inclusion or exclusion criteria.
~After clarification, time to think and consent, the examination is then carried out according to the protocol by approved doctors of the Clinic for Anesthesia, intensive care and pain therapy. Followed by digital storage for the finding.
~After the subsequent operation, the investigator determines whether knowledge of detected pathologies would have an effective influence on the anesthesiological procedure or not."
15841395|NCT04112407|Device|Blue Light Phototherapy|Phototherapy in the blue light spectrum
15841396|NCT04112407|Drug|Benzyl Peroxide|Benzyl peroxide wash to be used preoperatively during showering to the operative shoulder site.
15841397|NCT04112407|Other|Control|Standard surgical site preparation with no P. acnes pretreatment
15841398|NCT04112394|Other|local anesthetic injection|A linear ultrasound transducer will be place in a longitudinal parasagittal orientation about 3 cm lateral to spinous process. Local anesthetic mixture will be injected bilaterally into the fascial plane on the deep aspect of erector spinae muscle. Standard perioperative and postoperative analgesia protocol will be given and postoperative pain levels will be determined by Numerical rating scale (NRS).
15841399|NCT04112394|Other|Standard perioperative and postoperative analgesia protocol.|Standard perioperative and postoperative analgesia protocol will be given consisting of paracetamol 1 gr IV and tenoxicam 20 mg IV initiated after induction of anesthesia. At the end of the operation patients will receive contramal 1 mg/kg IV before extubation. Postoperative pain levels will be determined by Numeric Rating Scale (NRS) system, 20 minutes intervals in the first hour and at 2th, 6th, 12th and 24 th hour. For the first hour in the postoperative care unit, tramadol 50 mg IV will be given for rescue analgesia with minimum 20 minutes between doses, in patients showing a NRS ≥ 4. Paracetamol 1 g / 12 hour will be given during ward follow-up. In the ward in patients showing a NRS ≥ 4 tramadol 50 mg IV will be given for analgesia.
15841955|NCT04107779|Other|Switch from UB of Combustible Cigarette to JUUL 5% Mint ENDS|JUUL 5%, ENDS for 6-days in confinement
15841401|NCT04112368|Drug|Estradiol Transdermal Patch 0.1 mg/24 hrs|Estradiol transdermal patch delivering 0.1 mg/24 hour administered by affixing to skin for 14 days starting on day 7 after ovulation
15841402|NCT04112368|Drug|Oral Micronized Progesterone 200mg|100 mg oral micronized progesterone taken orally twice daily for 14 days starting day 7 after ovulation (200mg total per day)
15841403|NCT04112368|Drug|Inactive Clear Patch|Matching placebo patch administered by affixing to skin for 14 days starting on day 7 after ovulation
15841404|NCT04112368|Drug|Placebo capsule|Matching placebo capsules administered twice daily for 14 days starting day 7 after ovulation
15841405|NCT04112355|Other|Blood Collection|Blood draw
15841406|NCT04112342|Device|India Ink measurement|The India ink we propose to use in this study consists of 20-50 μL of Carlo Erba India ink injected in subcutaneous or submucosal tissue. This ink (referred to herein as Carlo Erba ink or CE ink or India ink) is based on a paramagnetic black pigment: purified and depyrogenated charcoal manufactured by Carlo Erba that is prepared as a sterile ink using the protocol developed at the lab of Bernard Gallez. The India ink will be injected subdermally into the tumor.
15841407|NCT04112342|Device|SPOTChip measurement|The SPOTChip is made in the form of a thin, circular in shape, disc/film having a diameter of 6-mm. After placing the SPOTChip on the tumor, it is covered with an oxygen barrier material secured to the skin by an FDA approved medical transfer adhesive.
15841408|NCT04112329|Behavioral|Exergaming|will use the PlayPulse exergame for 45 minutes a minimum of two times per week for 8 weeks.
15841409|NCT04112316|Drug|liothyronine or placebo|Each treatment period of liothyronine or placebo will be approximately 8 weeks in duration, with weekly titration of study drug for four weeks, followed by a maintenance dose for 4 weeks, then 2-week washout before crossing over to receive the alternate therapy - placebo or LT3.
15841410|NCT04112303|Drug|SOF/VEL|400/100 mg tablets administered orally once daily
15841411|NCT04112277|Drug|Cumulative morphine consumption|morphine equivalent [mg] 24 hours after the procedure
15841412|NCT04112264|Procedure|Monopolar radiofrequency ablation|a radiofrequency cannula is advanced under USG guidance towards the nerve. The final position will be confirmed by using nerve stimulator with elicitation of paraesthesia along the area of knee joint supplied by that respected genicular nerve by stimulation at 50 Hz current of <0.5 mV. The motor stimulation will be negative at all instances. For each genicular nerve, two conventional RF lesions are done for 120s at 80° of temperature using the Neurotherm 1100 RF generator.
15841413|NCT04112264|Procedure|Bipolar radiofrequency ablation|Two radiofrequency cannula are advanced under USG guidance towards the nerve. The final position will be confirmed by using nerve stimulator with elicitation of paraesthesia by stimulation at 50 Hz current of <0.5 mV. The motor stimulation will be negative at all instances. For each genicular nerve, two conventional RF lesions are done for 120s at 80° of temperature using the Neurotherm 1100 RF generator.
15841414|NCT04112251|Dietary Supplement|Cocoa Flavonols Supplement|Whose total capsule content of 500 mg of cocoa flavonoids, 50 mg correspond to (-) - epicatechin per capsule, with a total dose of this compound being 100 mg/day.
15841415|NCT04112225|Behavioral|Happify|An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction.
15841416|NCT04112212|Drug|Vedolizumab-800CW|Intraveniously administration of vedolizumab-800CW.
15841417|NCT04112212|Device|Fluorescence endoscopy and spectroscopy|Molecular Fluorescence Endoscopy platform A flexible fluorescence fiber-bundle is attached to a fluorescence camera platform to enable the detection of fluorescence signals. The fluorescence fiber-probe is inserted through the standard working channel of the standard clinical endoscope.
15841419|NCT04112186|Behavioral|Behavioral group therapy #1|Participants will participate in an 8-weeks of group therapy that uses psychological principles including mindfulness training, and could help decrease cravings for heroin and increase general well-being.
15841420|NCT04112186|Behavioral|Behavioral group therapy #2|Participants will participate in an 8-weeks of group therapy that uses psychological principles (but not including mindfulness training) and could help decrease craving for heroin and increase general well-being.
15841421|NCT04112173|Behavioral|perturbation-based fall-recovery training|Participants will attempt to recover from treadmill-induced balance perturbations as they walk or stand. The size of the perturbations is progressively challenging and dependent upon participant performance.
15841422|NCT04112160|Drug|Ketorolac|IM injection of either normal saline or Ketorolac
15841423|NCT04112160|Drug|normal saline|normal saline
15841424|NCT04112147|Drug|Antroquinonol capsule 100mg|Patients will receive 12-week of 50mg BID Antroquinonol
15841425|NCT04112147|Drug|Antroquinonol capsule 200mg|Patients will receive 12-week of 100mg BID Antroquinonol
15841426|NCT04112147|Drug|Placebo oral capsule|Patients will receive 12-week of 100mg BID Antroquinonol placebo
15841427|NCT04112121|Behavioral|Meeting with a Chaplain coupled with Biblical Readings|
15841428|NCT04112108|Procedure|PTMC|percutaneous mitral ballooning with Inoue balloon
15841429|NCT04112095|Drug|Norgestrel 0.075 mg tablets|"All subjects enrolled in the use phase of this open-label study will be given the opportunity to purchase and take one Norgestrel 0.075 mg tablet daily up to 24 weeks.
~Subjects will use the investigational product based on their understanding of the directions on the outer packaging called the Drug Facts Label and information inside the product packaging called the Consumer Information Leaflet."
15841430|NCT04112082|Behavioral|Mobile Neurofeedback|Home-based neurofeedback training (downtrain theta, uptrain beta; training site: Cz) 4 times weekly for a 40 of total sessions over the ten-week training period. Session duration of 21 minutes for the first 20 sessions to 30 minutes for the last 20 sessions. Positive visual and auditory feedback when brainwaves are within the desired range.
15841458|NCT04111848|Drug|Ketamine|"Patients will be assigned into 2 groups (each of 45):
~Ketamine group (group K): will receive a bolus of 0.5 mg/kg ketamine during induction of anaesthesia diluted in 100 ml normal saline, followed by ketamine infusion 0.12 mg/kg/hour continued till 24 hours after surgery. The infusion pump concentration will be 0.6mg/ml and the rate of infusion will be 0.2 ml/kg/hour."
15841956|NCT04107779|Other|Switch from UB of Combustible Cigarette to JUUL 3% Mint ENDS|JUUL 3%, ENDS for 6-days in confinement
15841431|NCT04112082|Other|Treatment as Usual|Treatment plan as part of regular care at the ADHD clinic, which may include pharmacological intervention, cognitive behavioral therapy (CBT), a combination of pharmacological intervention and CBT, or no intervention. Care will often include pharmacological intervention, with the specifics (e.g., type of medication, dosage) determined by psychiatrist recommendation considering such factors as response to previous interventions, participant characteristics, and practical constraints. Most pharmacological interventions will be stimulants (e.g., methylphenidate) with various release mechanisms. Each participant will receive an individualized dose titration and follow-up plan, including clinic visits as needed (generally 1-2 visits over the 10-week intervention period); interventions may be switched in accord with clinical judgment.
15841432|NCT04112069|Device|iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog|iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog
15841433|NCT04112069|Other|Usual Care|Usual care
15841434|NCT04112056|Dietary Supplement|Drink the study formula (NAN Comfort producted by Nestle Deutschland AG)|It is same as that stated in arm description.
15841435|NCT04112043|Behavioral|Walking Exercise|Participants randomized to this intervention 3 days/week of supervised, center-based walking exercise.
15841436|NCT04112043|Drug|Nicotinamide Riboside (NR)|Participants randomized to this intervention will receive 1,000 mg/day of NR.
15841437|NCT04112030|Diagnostic Test|Digital image analysis|
15841438|NCT04112017|Device|YVOIRE Y-Solution 360|Hyaluronic acid
15841439|NCT04112004|Other|Collecting sodium reports and outcome measures|
15841440|NCT04111991|Behavioral|Usual Care|Usual care in the NCH in the Complex Concussion Clinic involves assessment and treatment with a neurologist for medical management of concussion, weekly sessions with an athletic trainer for exercise therapy, and physical therapy sessions depending on need
15841441|NCT04111991|Behavioral|C-STEP (Cognitive Behavioral Therapy)|The C-STEP intervention involves 4 primary components: psychoeducation, activity management, sleep hygiene, and relaxation training
15841442|NCT04111978|Drug|Letrozole 2.5mg|Aromatase inhibitor
15841443|NCT04111978|Other|Placebo|Placebo tablet of Femara
15841444|NCT04111965|Drug|Nanodrop®|minimum to meet 1 drop 4 times a day, both eyes
15841445|NCT04111965|Drug|Systane Balance|minimum to meet 1 drop 4 times a day, both eyes
15841446|NCT04111952|Device|CO2 laser|A single session of CO2 vaginal laser treatment
15841447|NCT04111952|Device|Sham laser|A single session of sham laser treatment.
15841448|NCT04111939|Other|Communities That HEAL|The Communities That HEAL (CTH) intervention is a community-engaged intervention designed to increase the adoption of an integrated set of evidence-based practices delivered across healthcare, behavioral health, justice, and other community-based settings. It includes 3 components: community engagement to assist key stakeholders in applying evidence-based practices to addressing their opioid crisis, a menu of evidence-based practices for communities to select and implement, and a communications campaign to build demand for evidence-based practices to address overdose and opioid use disorder.
15841449|NCT04111939|Other|Wait-list control|Communities in the wait-list control condition will continue usual care during the first 30 months of the trial. At month 31, Wave 2 communities will begin receiving the CTH intervention.
15841450|NCT04111926|Drug|Dexmedetomidine|A loading dose of dexmedetomidine (0.6 μg/kg) was administered during a 10-minute period before anaesthesia induction, followed by a continuous infusion at a rate of 0.5 μg/kg/hr till 1 hour before the end of surgery.
15841451|NCT04111926|Drug|Placebo|Volume-matched normal saline was administered in the same rate for the same duration as in the intervention group.
15841452|NCT04111913|Drug|Anlotinib Hydrochloride|anlotinib once daily on days 1-14 of 21days cycle.
15841453|NCT04111900|Behavioral|Sleep/Circadian Friendly|This intervention attempts to improve sleep and prevent circadian rhythm dysregulation among patients admitted to the medical intensive care unit (MICU). Patients within his arm will be asked to try to keep their TV off and limit their telephone use from 10pm-7am, as well as limit the amount of visitors in their room as much as possible between those hours. Patients will also be offered ear plugs and eye masks if they wish to use at night to aid in helping them sleep, if deemed medically safe to do so. Additionally nurses will be asked to bathe patients either before 10pm or after 7am, to limit their conversations in the patient's room at night, and try as much as possible to limit blood draws and waking patients during those hours as is medically safe. Nurses will also be instructed to lower the blinds in the room at 10 pm and raise them up at 7am to help with patients sleep/wake cycle.
15841454|NCT04111887|Behavioral|Group-based therapy|College students with depressive symptoms will be randomized to one of three conditions: 1) a cognitive behavioral prevention intervention, 2) a cognitive behavioral prevention intervention with counter-attitudinal elements or 3) an educational brochure control. We will test if the additional of counter attitudinal elements produces intervention effects when delivered to participants with sub threshold depressive symptoms.
15841455|NCT04111874|Behavioral|Cognitive Behavioral Teletherapy LTA|Participating families will receive a copy of the book 'Helping Your Anxious Child, 2nd Edition', as well as the companion parent and child workbooks, to use at home and in session with the therapist. During each of the four videoconferencing sessions, therapists will serve to provide encouragement and support as the parent works through the program independently.
15841456|NCT04111874|Behavioral|Cognitive Behavioral Teletherapy STA|Participating families will also receive a copy of the book 'Helping Your Anxious Child, 2nd Edition', as well as the companion parent and child workbooks, to use at home and in session with the therapist. During each of the ten videoconferencing sessions, therapists will guide the parent through the implementation of the program, including explaining materials, assisting to develop planned therapy activities with the child, and problem-solving as needed.
15841457|NCT04111861|Other|Singing|To investigate whether singing can help people to manage their chronic pain the applicants, working together with people with chronic pain, have developed a singing intervention, Singing for Chronic Pain (SCP). The development of the programme has been supported by Snape Moultings, an international centre for the arts which offered the team a residency to develop the programme (https://snapemaltings.co.uk/music/residencies/). The model takes a holistic approach using voice and singing, movement, sound, mindfulness and breath work to provide opportunities to connect body, voice, breath and mind. This is important given that people often use body dissociation as a way to cope with physical pain
15841957|NCT04107779|Other|Switch from UB of Combustible Cigarette to JUUL 5% Menthol ENDS|JUUL 5%, ENDS for 6-days in confinement
15841459|NCT04111848|Drug|ketamine and magnesium|Ketamine and magnesium group (group KM): will receive a bolus of 0.5 mg/kg ketamine added to 50mg/kg magnesium sulfate diluted in 100 ml normal saline over 30 minutes after induction of anaesthesia, followed by ketamine infusion 0.12 mg/kg/hour added to 8mg/kg/hour of magnesium sulfate continued till 24 hours after surgery. Each ml of the administered infusion will contain 0.6mg ketamine and 40mg magnesium and the rate of infusion will be 0.2 ml/kg/hour.
15841460|NCT04111835|Diagnostic Test|Offering an alternative cervical cancer screening method - hrHPV molecular testing.|"Women randomized to this screening strategy group will take a hrHPV molecular test.
~hrHPV-positive - reflex LBC:
~Abnormal reflex LBC (ASC-US or worse) -> colposcopy
~Normal reflex LBC -> repeat LBC in 6 months
~Positive - colposcopy
~Negative - rescreen in 3 years
~HPV-negative - rescreen in 5 years"
15841461|NCT04111822|Drug|red blood cells transfusion, tranexamic acid (TXA) and fibrinogen concentrate|Phase III, randomized, multicenter, open-label and parallel group pilot study, which aims to study mortality at 28 days of admission in patients with septic shock treated with usual management and patients treated with ascorbic acid, thiamine and hydrocortisone added to usual driving
15841462|NCT04111822|Drug|on crystalloid fluid and Tranexamic acid|Resuscitation with crystalloids, Performing culture battery, antibiotic therapy
15841463|NCT04111809|Biological|Blood and urine collection|collected 10 mL of blood and 15 mL of urine every 2 months until 12 months
15841464|NCT04111796|Other|nature based solution for stress reduction|participation in nature activities: 30 min stress management in nature and group activity (walking, cycling)
15841465|NCT04111783|Device|POU protocol ultrasound|The evaluation method performed a preoperative examination of the patient within 10 minutes by a heart scan and a standard scan of the face, a large vascular scan under the xiphoid, a body cavity scan, and a standard scan of the face and a lung scan. Preparation, providing anesthesia and surgeons with a fast, comprehensive and accurate preoperative judgment with important clinical and social significance.
15841466|NCT04111770|Device|IVUS guided Percutaneous Coronary Intervention|Pre-procedural IVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent.
15841467|NCT04111770|Device|QCA guided Percutaneous Coronary Intervention|QCA will be used to determine lesion characteristics
15841468|NCT04111757|Device|Technolas® TENEO 317 Model 2|LASIK eye surgery
15841469|NCT04111744|Other|Preoperative Exercise Training|Patients undergoing CABG and randomized to the Training Group complete six sessions of aerobic endurance training prior CABG surgery
15841470|NCT04111744|Other|Optimal medical therapy|Standard medication for stable CAD
15841471|NCT04111731|Procedure|Cryoballoon pulmonary vein isolation|Catheter ablation using cryoballoon pulmonary vein isolation. Utilisation of a 'cold balloon' (Cryoenergy or cryoballoon ablation) to freeze the bases of the 4 pulmonary veins to achieve electrical isolation.
15841472|NCT04111731|Procedure|Radiofrequency pulmonary vein isolation|Catheter ablation using radiofrequency energy to achieve pulmonary vein isolation. Radiofrequency energy is delivered through the tip of a catheter to make tiny burns (ablation lesions) around the outlines of the 4 pulmonary veins at their bases
15841473|NCT04111731|Procedure|Repeat electrophysiological study|All participants will receive a repeat electrophysiological study 2 months after the index procedure during which radiofrequency catheter ablation guided by ultra-high density mapping will be used to identify regions of reconnection that need re-isolation; other tests will be carried out including testing for arrhythmia inducibility
15841474|NCT04111731|Procedure|Left atrial posterior wall isolation|The left atrial posterior wall will be isolated in Group 2 participants (those who received radiofrequency ablation at the index procedure) during the repeat electrophysiological study in 2 months
15841475|NCT04111718|Biological|Platelet-rich plasma (PRP)|Autologous platelet-rich plasma which will be derived from blood drawn from the patient.
15841476|NCT04111718|Behavioral|Viewing of preparation|The patient will receive a description of the preparation process and will view the preparation in the centrifuge.
15841477|NCT04111705|Drug|Lorlatinib|100 mg once daily
15841478|NCT04111679|Other|Music|Participant selected music, applied using noise cancelling headphones
15841479|NCT04111666|Biological|AL101|Active dose of AL101
15841480|NCT04111666|Other|Placebo|Saline solution administered as a single infusion as palcebo.
15841481|NCT04111653|Other|Mud therapy|Application of sludge poultice
15841482|NCT04111640|Other|CoRe software|Computer-supported cognitive training (CT)
15841483|NCT04111640|Other|Control Group|Paper and pencil cognitive training (paper-and-pencil CoRe version)
15841484|NCT04111627|Behavioral|Aerobic exercise|Participants with symptomatic knee osteoarthritis and depressive symptoms will be enrolled in a progressive walking program designed to reduce pain and disability and improve psychosocial health.
15841485|NCT04111627|Drug|Duloxetine|Duloxetine is an FDA-approved selective serotonin and norepinephrine reuptake inhibitor antidepressant approved for the treatment of neuropathic pain in symptomatic knee osteoarthritis as well as depression in adults. Participants with symptomatic knee osteoarthritis and depressive symptoms will receive duloxetine to decrease pain and depression severity to enhance their ability to engage in aerobic exercise.
15841486|NCT04111614|Drug|Tofacitinib tablet|Single dose of tofacitinib 5 mg tablet
15841487|NCT04111614|Drug|Tofacitinib Oral Solution|Single 5 mL dose of tofacitinib oral solution (1 mg/mL)
15841488|NCT04111601|Device|Blue light imaging|Advanced virtual chromoendoscopy
15841489|NCT04111588|Other|Diagnostic Amino acid PET/MRI examination|Diagnostic Amino acid PET/MRI examination
15841490|NCT04111575|Behavioral|Music Therapy|Music Therapy
15841491|NCT04111562|Procedure|Cranioplasty|Bone grafts
15841492|NCT04111549|Other|Home-based telehealth GOALS|Goal Oriented Attentional Self-Regulation (GOALS) is a manualized cognitive training intervention for problems with attention and executive control that has been shown to improve cognitive, emotional, and functional outcomes in civilians and Veterans with history of TBI, including Veterans 65 and older, and healthy older adults. It will be delivered to aging Veterans with history of TBI via in-home video telehealth.
15841650|NCT04110353|Other|Wound dressings: ciVAC dressings|Closed incision VAC dressings to be placed on closed wounds post operatively, after open operations on the bowel. To be changed at day 7 or sooner if clinically indicated.
15841958|NCT04107779|Other|Switch from UB of Combustible Cigarette to JUUL 3% Menthol ENDS|JUUL 3%, ENDS for 6-days in confinement
15841493|NCT04111549|Other|In-person GOALS|Goal Oriented Attentional Self-Regulation (GOALS) is a manualized cognitive training intervention for problems with attention and executive control that has been shown to improve cognitive, emotional, and functional outcomes in civilians and Veterans with history of TBI, including Veterans 65 and older, and healthy older adults. It will be delivered to aging Veterans with history of TBI in person.
15841494|NCT04111536|Drug|liothyronine or placebo|Each treatment period of liothyronine or placebo will be approximately 8 weeks in duration, with weekly titration of study drug for four weeks, followed by a maintenance dose for 4 weeks, then 2-week washout before crossing over to receive the alternate therapy - placebo or LT3.
15841495|NCT04111523|Drug|SY-007|A single dose of SY-007 or placebo injection(1mg-45mg)
15841496|NCT04111510|Drug|Tumor infiltrating lymphocytes (TIL) LN-145|"The TIL autologous therapy with LN-145 is comprised of the following steps:
~Tumor resection to provide the autologous tissue that serves as the source of the TIL cellular product;
~LN-145 investigational product production at a central Good Manufacturing Practice (GMP) facility;
~A 7-day nonmyeloablative lymphodepletion (NMA-LD) preconditioning regimen (hospitalization per institution standards);
~Infusion of the autologous LN-145 product on Day 0 (during inpatient hospitalization);
~Intravenous (IV) interleukin-2 (IL-2) administrations for up to six doses maximum (during inpatient hospitalization)."
15841497|NCT04111497|Drug|Glasdegib|Given PO
15841498|NCT04111484|Other|Adrenomedullin|Adrenomedullin is a naturally found in the human body and has strong vasoactive properties.
15841499|NCT04111484|Other|Saline|Placebo
15841500|NCT04111471|Drug|Prebiotics|Enrolled patients will receive 10 grams of inulin daily for 21 days
15841501|NCT04111471|Drug|Placebos|Enrolled patients will receive 5.6 grams of placebo powder daily for 21 days
15841502|NCT04111458|Drug|BI 1701963|Tablet
15841503|NCT04111458|Drug|Trametinib|Tablet
15841504|NCT04111445|Drug|ADG116|IV infusion at Day 1 of each cycle
15841505|NCT04111432|Biological|Concomitant administration of EV71vaccine with EPI vaccines|The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.# the MMR vaccine was manufactured by Shanghai Institute of Biological Products Co.,Ltd.; the Live attenuated Japanese encephalitis vaccine was manufactured by Chengdu Institute of Biological Products Co.,Ltd.
15841506|NCT04111432|Biological|Single injection of EPI vaccine|The MMR vaccine was manufactured by Shanghai Institute of Biological Products Co.,Ltd.; the Live attenuated Japanese encephalitis vaccine was manufactured by Chengdu Institute of Biological Products Co.,Ltd.
15841507|NCT04111432|Biological|EV71 Vaccine only|The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.
15841508|NCT04111419|Drug|Amlodipine/Atorvastatin 5 Mg-20 Mg ORAL TABLET|amlodipine/atorvastatin (5/20mg tablet) once a day
15841509|NCT04111419|Drug|Amlodipine/Atorvastatin 5 Mg-10 Mg ORAL TABLET|amlodipine/atorvastatin (5/10mg tablet) once a day
15841510|NCT04111419|Drug|Allisartan Isoproxil|allisartan (240mg/tablet) once a day
15841511|NCT04111406|Drug|Current practice|Epidural insertion and epidural drug administration depend on anesthetist in charge
15841512|NCT04111406|Drug|Protocol based|"Epidural insertion and epidural drug administration depend on anesthetist in research team using protocol based
~insertion at mid-level of surgical insertion
~insertion depth is 3-5 cm in space, not more than 5 cm
~using benzoin tincture and transparent dressing to fix catheter
~test dose with 2%xylocaine with adrenaline 1:200,000 3ml If not cover desired dermatome: 2% lidocaine with adr added 3 ml every 5 min (up to 2 times)
~After induction and patients' hemodynamic are stable. Load 2 mg morphine with 0.0625% bupivacaine + morphine 0.02 mg/ml 3 ml then continuous infusion with rate according to initial local anesthetic requirement for incisional area coverage"
15841513|NCT04111393|Procedure|transoral specimen extraction|transoral specimen extraction during laparoscopic gastric resection
15841514|NCT04111380|Drug|cisplatin and nab-paclitaxel|Nab-paclitaxel, 130mg/m2, d1,d8, Cisplatin, 20mg/m2, d1-3 ,3week, 4-6 cycles.
15841515|NCT04111367|Drug|Seraprevir|Subjects will receive oral tablets of Seraprevir 100 mg, twice a day from Day 1 up to Week 12，the other group will receive the same dose for 24 weeks.
15841516|NCT04111367|Drug|Sofosbuvir|Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12,the other group will receive the same dose for 24 weeks.
15841517|NCT04111354|Device|Pacemaker implantation|Pacemaker implantation
15841518|NCT04111341|Drug|TCM (Gan-Lu-Yin)GLY|TCM Gan-Lu-Yin 6g in the morning TCM Jia-Wei-Xiao-Yao-San, Ye-Jiao-Teng, Suan-Zao-Ren 8g in the evening for 12 weeks
15841519|NCT04111341|Drug|PLACEBO|TCM Placebo 6g in the morning TCM Placebo 8g in the evening for 12 weeks
15841520|NCT04111328|Drug|intravenous sufentanil|The PCA pumps contain sufentanil . And the pump is connected to participants intravenously .
15841521|NCT04111328|Drug|subcutaneous sufentanil|The PCA pumps contain sufentanil. And the pump is connected to participants subcutaneously.
15841522|NCT04111328|Drug|intravenous hydromorphone|The PCA pumps contain hydromorphone. And the pump is connected to participants intravenously .
15841523|NCT04111328|Drug|subcutaneous hydromorphone|The PCA pumps contain hydromorphone. And the pump is connected to participants subcutaneously.
15841524|NCT04111328|Drug|intravenous sufentanil and dexmedetomidine|The PCA pumps contain sufentanil and dexmedetomidine. And the pump is connected to participants intravenously .
15841525|NCT04111328|Drug|subcutaneous sufentanil and dexmedetomidine|The PCA pumps contain sufentanil and dexmedetomidine. And the pump is connected to participants subcutaneously.
15841526|NCT04111328|Drug|intravenous hydromorphone and dexmedetomidine|The PCA pumps contain hydromorphone and dexmedetomidine. And the pump is connected to participants intravenously.
15841527|NCT04111328|Drug|subcutaneous hydromorphone and dexmedetomidine|The PCA pumps contain hydromorphone and dexmedetomidine. And the pump is connected to participants subcutaneously
15841528|NCT04111315|Drug|Metamizole Sodium|Novalgin® Oblong tablets 0,5 g 2-2-2
15841529|NCT04111315|Drug|Ibuprofen 600 mg|Ibufen-L® tablets 500 mg 2-2-2
15841530|NCT04111315|Behavioral|Patient education|Leaflet and phone call
15841531|NCT04111302|Other|IV-PCA|IV-PCA contains dezocine 10mg, sufentanil 100ug, metoclopramide 20mg and normal saline are prepared into 100ml solution and pumped evenly at the speed of 2ml/h.
15841532|NCT04111302|Other|IV-dezocine|IV-dezocine contains dezocine 5mg and 250ml normal saline are made into solution and injected intravenously twice a day for 3 consecutive days after surgery.
15841533|NCT04111302|Other|IV-PCA+AA|IV-PCA contains dezocine 10mg, sufentanil 100ug, metoclopramide 20mg and normal saline are prepared into 100ml solution and pumped evenly at the speed of 2ml/h. And selecting the auricular points TF4, AH6a, HX2, HX5, CO4, AT4 and cowherb seeds will be attached to each auricular point after the auricle skin is disinfected. The participants will be asked to press the cowherb seeds against the auricular points every 2 hours during waking hours; each point is stimulated for one minute. Auricular points are pressed unilaterally, and the cowherb seeds will be replaced with new ones every 2 days, alternating from left to right.
15841534|NCT04111302|Other|IV-dezocine+AA|IV-dezocine contains dezocine 5mg and 250ml normal saline are made into solution and injected intravenously twice a day for 3 consecutive days after surgery.And selecting the auricular points TF4, AH6a, HX2, HX5, CO4, AT4 and cowherb seeds will be attached to each auricular point after the auricle skin is disinfected. The participants will be asked to press the cowherb seeds against the auricular points every 2 hours during waking hours; each point is stimulated for one minute. Auricular points are pressed unilaterally, and the cowherb seeds will be replaced with new ones every 2 days, alternating from left to right.
15841535|NCT04111289|Drug|-Administration of tirofiban (25 ug/kg bolus and 0.15 ug/kg/min maintenance infusion)|"After consenting for primary PCI ,the patient will be assigned to one arm ( either upstream high bolus dose IV before going to cath lab or selective downstream administration according to operator discretion )
~Administration of tirofiban (25 ug/kg bolus and 0.15 ug/kg/min maintenance infusion)
~Randomization will be performed by Microsoft Excel where random order will be generated for the study population"
15841536|NCT04111276|Device|Breg Osteoarthritis Brace gait fluoroscopy|Gait under fluoroscopy surveillance with brace
15841537|NCT04111276|Other|Gait fluoroscopy without brace|Gait under fluoroscopy surveillance without brace
15841538|NCT04111276|Diagnostic Test|JointVue ultrasound|JointVue ultrasound procedure to reconstruct 3D femoral and tibial bones
15841539|NCT04111276|Diagnostic Test|Computer Tomography|Computer Tomography scan limited to the study knee and will image 6 inches distal on the tibia and 6 inches proximal on the femur
15841540|NCT04111263|Dietary Supplement|FP|Fiber and polyphenol blend
15841541|NCT04111263|Dietary Supplement|Placebo|Matched placebo
15841542|NCT04111263|Other|High altitude|Simulated high altitude in altitude chamber using hypobaric hypoxia
15841543|NCT04111263|Other|Sea level|Sea level environment in altitude chamber
15841544|NCT04111250|Procedure|Maxillary sinus augmentation|Raise the sinus membrane to graft bone substitute to augment the sinus cavity allowing implants placement.
15841545|NCT04111237|Behavioral|Two Finger technique|two finger method for chest compression provuision
15841546|NCT04111237|Behavioral|Two Thumb Technique|Two thumb technique
15841547|NCT04111224|Diagnostic Test|pentraxin 3 marker|Assess the role of pentraxin3 (PTX3) in the early diagnosis of ventilator-associated pneumonia (VAP).
15841548|NCT04111198|Radiation|Cardiac MRI|Cardiac MRI
15841549|NCT04111185|Device|Receive Blood Volume Analysis Guided Treatment|The health care team will be given the results of the blood volume analysis along with guidance on how to provide treatment based on the analysis
15841550|NCT04111172|Biological|Adenovirus 5/F35-Human Guanylyl Cyclase C-PADRE|Given as intramuscular injection
15841551|NCT04111159|Drug|HSK3486|Subjects < 65 years old:Initial dose of 0.4 mg/kg followed by 0.15 mg/kg if needed;Subjects ≥ 65 years old:75% of the dose for subjects < 65 years old.
15841552|NCT04111159|Drug|Propofol|Subjects < 65 years old:Initial dose of 2 mg/kg followed by 0.75 mg/kg if needed;Subjects ≥ 65 years old:75% of the dose for subjects < 65 years old.
15841553|NCT04111133|Drug|Betablocker + ivabradine|Use of maximum tolerated dose of carvedilol and ivabradine to achieve therapeutic heart rate reduction (THR) to 55-65 beats per minute
15841554|NCT04111133|Drug|Betablocker|Use of maximum tolerated dose of carvedilol to achieve targeted heart rate reduction (THR) to 55-65 beats per minute (responder) or inability to reach THR (non responder) with maximum dose of carvedilol, maintaining a minimum MAP of 70 mmHg.
15841555|NCT04111120|Diagnostic Test|SONOCLOT, coagulation factor assays for VIII/X, XIII, TPA/ PAI|Coagulation assessment using heparinase treated SONOCLOT
15841556|NCT04111107|Drug|Investigational Agent|Treatment will be administered on an inpatient or outpatient basis based on the type of medication selected. The investigatory will administer the drug as directed in the FDA approved label.
15841557|NCT04111107|Other|Supportive Care Regimens|Supportive care regimens will vary depending on the type of drug that will be administered at the treating investigator's discretion.
15841558|NCT04111107|Diagnostic Test|Next Gen Sequencing Report|1) Next Gen Sequencing report obtained as Standard of Care within the past 12 months of enrollment date will be used. If more than one report exists in this time period, the most recent report will be used.
15841559|NCT04111094|Diagnostic Test|No intervention|No intervention
15841560|NCT04111081|Other|Auricular pressure|Select related auricular points: Shenmen(TF4), sympathetic(AH6a), rectum(HX2), anus(HX5), stomach(CO4), subcortical(AT4). The auricle skin of the patient was disinfected 24 hours after the operation, and wanghuoxing seed will be used for stimulation. Ask patients press every two hours for one minute at each point. When the pain is severe, do pressure compressions at each point for 2 minutes once hour.
15841561|NCT04111081|Other|Shame auricular pressure|Select unrelated auricular points: eye(LO5), occipital(AT3), tonsil(LO7,8,9), lower auricular root(R3), dorsum auricular kidney(P5) and dorsum auricular lung(P2). The auricle skin of the patient was disinfected 24 hours after the operation, and wanghuoxing seed will be used for stimulation. Ask patients press every two hours for one minute at each point. When the pain is severe, do pressure compressions at each point for 2 minutes once hour.
15841562|NCT04111068|Device|anodal tDCS Active Stimulation|a weak electric current is applied to the head through electrodes to affect the cortical excitability of the targeted cells in the brain.
15841563|NCT04111068|Device|anodal tDCS Sham/Placebo Stimulation|The tDCS machine will be used as in active stimulation, except the electrical current will not be applied.
15841564|NCT04111055|Device|Closed-loop system|the CLV system will correct hypotension by automated adjustment of norepinephrine.
15841565|NCT04111042|Device|stenting|stenting procedure in patients diagnosed malignant large bowel occlusion
15841566|NCT04111029|Diagnostic Test|Cell Free DNA|Pre and post procedure plasma cell free DNA will be assessed for response to locoregional therapy
15841567|NCT04111016|Behavioral|Integrated child stimulation, nutrition, lead, arsenic, WASH intervention|The content of the intervention curriculum was developed considering the needs of the specific ages of the children attending the group, as well as the feasibility of delivering the package in the community. The pregnancy module encompasses information on significance of prenatal care for child development, physiological symptoms and solutions, maternal diet, education on kangaroo mother care (KMC), breast feeding, thinking healthy, hygiene, and lead and arsenic prevention. The curriculum for lactating mothers focuses on specialized messages for 4 age groups of children: 0-5 months, 6-11 months, 12-18 months and 19-24 months. The overall package includes information regarding WASH, psychosocial stimulation, nutrition, maternal mental health, lead and arsenic. As research evidence showed that psychosocial stimulation provided for 10 or 12 months can significantly improve child development, the psychosocial stimulation component is included in every fortnightly session.
15841568|NCT04111003|Procedure|local anesthesia|administering local anesthesia in the region of the planned restorative procedure
15841569|NCT04111003|Procedure|Tooth restored using SFRC filling|Restoration of an endodontivally treated molar using a shor-fiber base filling and veneering composite
15841570|NCT04111003|Procedure|Tooth restored using Ceramic indirect endocrown|Restoration of an endodontically treated molar using a ceramic indirect restoration
15841571|NCT04110977|Device|mobile application (reminder app)|This app will remind the patients four times a day to perform skin and mouth care. Instructions are given how to properly perform skin and mouth care. The patients may postpone each required care procedure for up to 2 hours. Finally, the patients are asked to state for each procedure whether or not they performed it. To increase the patients' motivation, they will earn points for each successfully performed care procedure.
15841572|NCT04110964|Drug|AAV-hTERT|subjects will receive a single LGT (AAV-hTERT) treatment via IV administration
15841573|NCT04110951|Behavioral|Pranayama Breathing Technique|Yogic Breathing Technique
15841574|NCT04110951|Behavioral|Relaxation technique|Progressive relaxation technique
15841575|NCT04110925|Genetic|Genetic Mutations|DNA sequencing for mutations to be obtained by bloodwork within 6 months of diagnosis, or by accessing diagnostic bone marrow aspirate slides.
15841576|NCT04110925|Other|Inflammatory and lipid markers|Bloodwork to be done for lipid profile, c-reactive protein (CRP), and multiplex chemokine/cytokine analysis.
15841577|NCT04110925|Other|Computed Tomography (CT) of the heart|Sunnybrook Patients with no history of cardiovascular disease [ex: past/present coronary artery disease (CAD), peripheral vascular disease (PVD), angina, myocardial infarction (MI), stroke, transient ischemic attack (TIA), or stents], not pregnant, and able to undergo CT will receive a CT of the heart to look for and quantify any occult coronary artery disease.
15841578|NCT04110912|Other|This is a registry and no interventions are taking place.|
15841579|NCT04110899|Other|Application of paratracheal force|An esophageal stethoscope is inserted into the upper esophagus under the application of different paratracheal force in anesthetized and paralyzed patients.
15841580|NCT04110886|Drug|HSK21542|Single dose, injection, starting dose of 0.2ug escalating up to 20ug
15841581|NCT04110886|Drug|Placebo|Single dose, injection matching placebo
15841582|NCT04110873|Drug|Antroquinonol Capsule 50mg|patients will receive Antroquinonol 50mg per day (QD) on Day 1 for 12 weeks
15841583|NCT04110873|Drug|Antroquinonol Capsule 100mg|patients will receive Antroquinonol 100mg per day (QD) on Day 1 for 12 weeks
15841584|NCT04110873|Drug|Placebo oral capsule|patients will receive placebo per day (QD) on Day 1 for 12 weeks
15841585|NCT04110860|Drug|voriconazole gel once daily|voriconazole is incorporated into a nanoemulsion intermediate gel state then applied on the affected areas once daily
15841586|NCT04110860|Drug|voriconazole gel twice daily|voriconazole is incorporated into a nanoemulsion intermediate gel state then applied on the affected areas twice daily
15841587|NCT04110860|Drug|placebo|the same procedure as before is used to prepare the nanoemulsion intermediate gel but the active ingredient, voriconazole, is not added then applied twice daily in the same manner
15841588|NCT04110847|Drug|JING CEIH SHERN YUAN EXTRACT PILL|Oral use, 3#BID
15841589|NCT04110834|Drug|itraconazole gel once daily|itraconazole is incorporated into a nanoemulsion intermediate gel state then applied on the affected areas once daily
15841590|NCT04110834|Drug|itraconazole gel twice daily|itraconazole is incorporated into a nanoemulsion intermediate gel state then applied on the affected areas twice daily
15841591|NCT04110834|Drug|placebo|the same procedure as before is used to prepare the nanoemulsion intermediate gel but the active ingredient, itraconazole, is not added then applied twice daily in the same manner
15841592|NCT04110808|Drug|hypotensive anaesthesia using Nitroglycerine|"effect of hypotensive anaesthesia using Nitroglycerine vs Phentolamine on Event related potentials, quantitative Electroencephalograghy and cognitive function
~Phentolamine group (30 patients): Patients will receive hypotensive anesthesia with phentolamine infusion via syringe pump by adding 20 mg (2ml) of Phentolamine to 48 ml of normal saline making it to final concentration of 0.4 mg/ml at the rate of 0.1-2 mg/min according to the patients desired target blood pressure.
~Nitroglycerine group (30 patients): Patients will receive hypotensive anesthesia with nitroglycerine infusion via syringe pump by adding 5mg (5ml) of Nitroglycerin to 45ml of normal saline making it to final concentration of 100μg/ml at the rate of 0.5- 10 μg/kg/min according to the patients desired target blood pressure."
15841593|NCT04110795|Other|No Intervention|No Intervention
15841594|NCT04110782|Other|Radium223|55 kBq/ Kg
15841595|NCT04110769|Diagnostic Test|next generation sequencing|the investigator will compare genetic mutation between responder and non-responder using next generation sequencing examination.
15841596|NCT04110769|Diagnostic Test|following next generation sequencing|The patient will be examined next generation sequencing before changing palliative chemotherapy for non-responders.
15841651|NCT04110340|Drug|Ciprofloxacin|"Adults: Ciprofloxacin 500mg orally twice daily (or 400mg IV twice daily for those who cannot take oral medication) for 10 days;
~Children:Ciprofloxacin 15mg/kg twice daily (max 500mg per dose) orally (or 10mg/kg IV twice daily for those who cannot take oral - maximum dose 400mg) for 10 days.
~Patients who begin intravenous therapy may switch to oral administration once they are able to swallow or once deemed clinically appropriate by the treating physician."
15841959|NCT04107779|Other|Switch from UB of Combustible Cigarette to JUUL 5% Mango ENDS|JUUL 5%, ENDS for 6-days in confinement
15842319|NCT04104971|Diagnostic Test|blood tests , abdominal US and doppler|
15841597|NCT04110756|Behavioral|ChangeGradients|In the proposed intervention, adolescents at the UCSF clinics who endorse alcohol use on the Health e-Check screen, a 5-minute confidential risk behavior module, will be randomly assigned to either the CHANGEGRADIENTS Intervention or Comparison (no intervention). The CHANGEGRADIENTS system will generate behavior change narrative episodes that are tailored to the adolescent (e.g. level of alcohol use) while also universally addressing a core set of topics related to health behavior change. Shortly following the clinic visit, through 4 weekly, 20 minute episodes, adolescent participants will interact with the CHANGEGRADIENTS health behavior change environment outside of clinic. Adolescents will complete a brief alcohol screening-past 7-day use-at the beginning of each episode. At the end of the final episode, the system will produce an individualized adolescent report that summarizes use of the CHANGEGRADIENTS modules as well as self-reported alcohol use since clinic visit baseline.
15841598|NCT04110743|Device|EXPLORER PET/CT|Intervention: PET/CT using different protocols
15841599|NCT04110730|Device|3D Printed Upper-limb Prosthesis|The fingers and thumb were made of polylactic acid polymer manufactured using industrial 3D printers. The palm, socket, forearm brace, and leveraging structure were made of polylactic acid which has properties similar to thermoplastic that facilitate post manufacturing adjustments. Elastic cords placed inside the dorsal aspect of the fingers provided passive finger extension. Finger flexion was driven by non-elastic cords along the palmar surface of each finger and was activated through 20-30 degrees of wrist or elbow flexion.
15841600|NCT04110730|Behavioral|Home Intervention|An occupational therapy student will perform 3 home visits a week and will direct a training protocol that consists of completing three trials of a series of 6 block building activities (i.e., block-stacking) for each hand separated by 30 seconds of rest (a total of 18 block building activities per hand). The block stacking activity consists in building a 4 block train, 3 cube bridge, 4 block wall, 3 block tower, 6 block steps, and 6 block pyramid. All subjects including the control group will perform the same home training protocol.
15841601|NCT04110717|Device|Vestal Device|Vestibular nerve stimulator
15841602|NCT04110717|Device|Control Device|Control Device
15841603|NCT04110717|Behavioral|Hypocaloric Diet|Hypocaloric diet
15841604|NCT04110704|Procedure|Insertion of transvaginal cerclage|Transvaginal cerclage is inserted in women with a high risk of preterm birth. However it is unknown whether this alongside cervical length monitoring improves the incidence of preterm birth. The cerclage is inserted under regional analgesia.
15841605|NCT04110678|Drug|NeuroEPO|NeuroEPO [CIMAB S.A, Havana, Cuba]
15841606|NCT04110665|Drug|Tramadol|Tramadol 100 mg tablet
15841607|NCT04110665|Drug|Nefopam 20 MG/ML|120 mg for 24 hours
15841608|NCT04110665|Drug|Morphine Sulfate|Tablet 10mg
15841609|NCT04110665|Drug|Oxycodone 20mg|release
15841610|NCT04110652|Other|pulmonary rehabilitation program|"The pulmonary rehabilitation program consisting of inspiratory muscle training, manual hyperinflation. chest wall mobilization, rib-cage compression, cough function training, postural drainage and secretion removal will be applied to patient group.
~The program will be conducted by physical therapists for 30-45 minutes daily during ICU stay.
~The exercise intensity will be increased gradually over the course. Each patient's performance during the exercise sessions will be recorded and reported regularly."
15841611|NCT04110639|Device|Intracranial pressure (ICP) monitor|The investigators' hypothesis is that by utilizing an intracranial pressure (ICP) monitor to detect the presence or absence of waveforms in the femoral head, investigators could reliably assess the perfusion levels within the femoral head and possibly reduce the incidence of osteonecrosis.
15841612|NCT04110639|Other|Standard of Care|10 patients with minimally displaced femoral neck fractures (Garden 1) which will be pinned in situ without manipulation
15841613|NCT04110626|Other|Questionnaires|The questionnaires are completed at the 3 survey times (T0, T1 and T2) by all pupils involved. Collected data are quantitative
15841614|NCT04110626|Other|Non-directive Interviews|The interviews are conducted with 80 pupils/year randomly selected (i.e. 2 per class and 8 per establishment/year). Collected data are qualitative
15841616|NCT04110600|Other|Coffee effect on early gastric motility|this group 100ml coffee after two hours
15841617|NCT04110600|Other|Efficacy pepper mint oil on motility|This group 100me pepper mint oil after 2 hours
15841618|NCT04110587|Biological|Hyaluronic Acid|1 mL Hyaluronic Acid Injection (20 mg/mL, 7000 KDa) at the end of arthroscopy .
15841619|NCT04110587|Procedure|Temporomandibular Joint Arthroscopy|Lysis and Lavage
15841620|NCT04110587|Drug|Antibiotic therapy|Amoxicillin / Clavulanic Acid, 1g I.V. (Intraoperative); as well as Amoxicillin / clavulanic acid, 500/125 mg / 8h / 5 days by mouth (Post-operative).
15841621|NCT04110587|Drug|corticosteroid|Dexamethasone, 4 mg I.V. (Intraoperative)
15841622|NCT04110587|Drug|Antiinflammatories|Diclofenac 100 mg / 12h / 5 days by mouth (Post-operatively).
15841623|NCT04110587|Drug|Analgesics|Metamizol 575 mg / 8h by mouth (Post-operatively)
15841624|NCT04110587|Other|Exercise program|Home exercise program
15841625|NCT04110561|Device|Use of the Atalante exoskeleton|A session basically includes a stand up, walks over a distance of 10 meters, exercises, U-turns and a sitting
15841626|NCT04110548|Procedure|Emotion Regulation Task|"Participants are instructed to complete the emotion assessment after Look or Decrease the neutral or negative pictures. The Decrease asks the participants to use cognitive reappraisal or mindfulness strategies to decrease the intensity of emotion, whereas the Look asks the participants to look naturally at the picture. First, the look or decrease is displayed on the computer for 2 s. Then, a neutral or negative picture is presented on the screen for 7s. Finally, participants will rate the intensity of their emotion for 4s. Then, they have 1s-3s to relax before the next trial. In the meantime, Skin conductance activities will be recorded using a constant voltage with 1-cm 3 AgAg/Cl electrodes attached to the medial phalanx surfaces of the middle and index fingers of the nondominant hand."
15841677|NCT04110119|Drug|diclophenac sodium (75 mg, IM) and thiocolchicoside (4 mg, IM)|Single intramuscular injection of mixture of two commercial drugs (Analgesic-anti-inflammatory and myorelaxant) at the specified dosages
15841678|NCT04110119|Other|Chiropractic Treatment|High speed and low amplitude spinal manipulation techniques are applied to the case group.
15841679|NCT04110106|Other|no intervention|All participants were evaluated with the PDQ-39, and the severity of PD was recorded according to the H&Y scale by a neurologist.
15841627|NCT04110548|Procedure|Craving Regulation Task|"Participants are instructed to complete the craving assessment after Look or Decrease the neutral or gaming pictures. The Decrease asks the participants to use cognitive reappraisal or mindfulness strategies to decrease the intensity of craving, whereas the Look asks the participants to look naturally at the picture. First, the look or decrease is displayed on the computer for 2 s. Second, a neutral or gaming picture is presented on the screen for 7s. Third, participants rate the intensity of their craving for 4s. Then, they have 1s-3s to relax before the next trial. In the meantime, Skin conductance activities will be recorded using a constant voltage with 1-cm 3 AgAg/Cl electrodes attached to the medial phalanx surfaces of the middle and index fingers of the nondominant hand."
15841628|NCT04110535|Drug|Remimazolam|IV administration over 1 minute
15841629|NCT04110535|Drug|Midazolam|IV administration over 1 minute
15841630|NCT04110535|Other|Saline|IV administration over 1 minute
15841631|NCT04110522|Other|Direct to patient PsA Screening Questionnaire|Patients randomized to an intervention group will be asked to complete and score the 5-item Psoriasis Epidemiology Screening Tool (PEST) questionnaire. Those patients with an elevated score (PEST ≥3 out of 5) will be advised to complete a rheumatologic evaluation for PsA.
15841632|NCT04110496|Drug|RTX-134|RTX-134 is a cellular therapy containing AvPAL
15841633|NCT04110483|Procedure|Thulium fiber laser en-bloc resection of non-muscle-invasive bladder cancer|After cystoscopy and determining tumor topography, a circumferential incision around the tumor is made in the visually intact bladder mucosa (approximately 10 mm from the edges of the tumor). It allows for accurate morphological evaluation of the surgical margin. After that, the incision is continued deeper into the muscular layer. Having identified the layer, the surgeon resects the base of the tumor with the muscular layer using traction and incisions of the muscle fibers. Making incisions in the muscular layer requires precision, a full bladder and adequate guidance with visualization techniques. Traction may be employed with the help of the tip of the resectoscope or working element. After complete tumor resection, local hemostasis was performed.
15841634|NCT04110483|Procedure|Transurethral resection of non-muscle-invasive bladder cancer|After cystoscopy and determining tumor topography, a step-by-step resection of a tumor is done. Firstly, visible tumor is resected, then resection continues to the apparently normal mucosa on the border of the tumor, than resection of the muscle layer at the base of the tumor is performed until normal muscle fibers are visible.
15841635|NCT04110470|Diagnostic Test|X-ray|Patients will receive standard radiographs post-operative day one or two in hospital, as well as radiographs in clinic at two and six weeks.
15841636|NCT04110470|Diagnostic Test|No-Xray|These patients will not have routine post-operative in hospital radiographs, or radiographs in clinic at two weeks, unless clinically indicated.
15841637|NCT04110457|Procedure|spinal decompression|spinal surgery by decompression or fixation
15841638|NCT04110444|Drug|Sildenafil|oral sildenafil t.d.s for high-risk pregnancies
15841639|NCT04110431|Procedure|Left bundle branch pacing|Successful LBBP was defined as (1) LBBP lead is located at 1.5-2cm from His-bundle towards right ventricular apex; (2) Paced QRS morphology of right bundle branch delay(CRBBD) in lead V1; (3) Stimulus to the peak of R wave in V5 and V6 QRS wave, which represents left ventricular activation time(Stim-LVAT), is less than 100ms and constant at high and low output pacing; (4) Unipolar pacing threshold<1.5V/0.5ms; (5) Recording P potential when narrow QRS escape rhythm or CRBBB escape rhythm(not essential).
15841640|NCT04110431|Procedure|Biventricular pacing|Implantation of a LV pacing lead is attempted using the standard-of-care technique first.
15841641|NCT04110418|Drug|Methylene Blue|"Methylene Blue group (Group MB):will receive IV MB initiated with a first loading dose ( 1 mg/kg over 30 minutes ) then continuous IV infusion( 0.15 mg/kg per hour for up to 24 hours)
~Terlipressin Group (Group TP) Terlipressin will be initiated with a loading dose ( 2 μg/kg intravenous over 30 minutes ) followed by continuous IV infusion starting by 2 μg/kg/h escalating up every 15 minutes up to 20 μg/kg/h"
15841642|NCT04110405|Behavioral|Stepped Care|This stepped care model involves three steps. Step 1 is a peer and nurse co-led 8-session group based upon BRIDGES. Step 2 is peer or nurse led 6-session individual meetings based upon Interpersonal Psychotherapy. Step 3 is primary care physician led medication treatment with Amitriptyline.
15841643|NCT04110405|Behavioral|Standard of Care plus Healthy Lifestyle|Standard outpatient care supplemented with literature on healthy lifestyles will serve as an enhanced control condition. In each clinic, non-specialty mental health care is available in the form of counseling from doctors or nurses along with psychiatric medication management. Given the difficulties faced by women in Tajikistan, ethical responsibility compels us to enhance the control condition by having nurses distribute written materials on healthy eating, physical fitness, and personal hygiene, at a reading level which will be widely accessible.
15841644|NCT04110392|Dietary Supplement|Chaya (Cnidoscolus chayamansa)|Chaya Water Beverage of Chaya will be prepared as follows: 40 g of Chaya leaves will be treated with a commercial brand disinfectant following the manufacturer's instructions for use, then added 1L of purified water and mixed in blender. Finally, 500 mL of it will be placed in bottles. Participants will be instructed to consume 1 bottle per day for 6 weeks. 7 bottles will be delivered at each visit, which will be consumed during the week; participants will be instructed to keep the water refrigerated until it is consumed.
15841645|NCT04110379|Behavioral|Virtual Reality (VR)|All the dental procedures that will be done will be explained to the child using tell-show-do technique. VR glasses will be introduced to the child using tell-show-do technique and he will be given a choice of cartoon episodes to select from according to his own interest and age appropriate to view during the dental treatment. The child will be given five minutes to get familiar with the VR glasses before starting the dental treatment.
15841646|NCT04110379|Behavioral|Conventional Behavior Management Techniques|Conventional behavior management techniques will be done to relieve the child's dental anxiety during the dental treatment such as : tell-show-do technique, distraction, and positive reinforcement, according to the child's behavior.
15841647|NCT04110366|Biological|Live attenuated influenza vaccine|Vaccination with live attenuated influenza vaccine (LAIV)
15841648|NCT04110353|Other|Wound dressings: Conservative dressings|Conservative dressings to be placed on closed wounds post operatively, after open operations on the bowel. To be changed at day 7 or sooner if clinically indicated.
15841649|NCT04110353|Other|Wound dressings: Prevena dressings|Prevena dressing to be placed on closed wounds post operatively, after open operations on the bowel. To be changed at day 7 or sooner if clinically indicated.
15841652|NCT04110340|Drug|Streptomycin|"Control arm adults: streptomycin 1g twice daily for three days, followed by ciprofloxacin 500mg orally twice daily (or ciprofloxacin 400mg twice daily by IV for those unable to take orally) for an additional 7 days.
~Control arm children: streptomycin 15mg/kg twice daily for three days followed by ciprofloxacin 15mg/kg twice daily (max 500mg per dose) orally (or 10mg/kg IV twice daily for those who cannot take oral - maximum dose 400mg) for 7 additional days.
~Patients who begin intravenous therapy may switch to oral administration once they are able to swallow or once deemed clinically appropriate by the treating physician."
15841653|NCT04110327|Device|MicroStent|Treatment of arterial stenosis or occlusion with the MicroStent Perihperal Vascular Stent System
15841654|NCT04110314|Behavioral|Portal Reminders for Influenza Vaccination: Gain-framed|Patients receive gain-framed reminder/recall messages via the patient portal to get an influenza vaccination.
15841655|NCT04110314|Behavioral|Portal Reminders for Influenza Vaccination: Loss-framed|Patients receive loss-framed reminder/recall messages via the patient portal to get an influenza vaccination.
15841656|NCT04110314|Behavioral|Pre-commitment prompt|Patients receive a pre-commitment prompt asking about their intention to get an influenza vaccination
15841657|NCT04110301|Drug|Recombinant Humanized Monoclonal Antibody MIL62 Injection|1000mg /dose for 12 cycles(28 days) and a total of 11 doses :the first Cycle(Day1,Day15), the 2nd-8th Cycles(Day 1 every cycle);the 9th-12nd Cycles (One dose every two cycles).
15841658|NCT04110301|Drug|Lenalidomide|Dose on days 2-22 every 28 days x 12 cycles: the starting dose is 10-mg ; Adjusted dose according to the tumor response or toxicity reaction
15841659|NCT04110288|Drug|Paclitaxel|Paclitaxel to treat peripheral arterial disease
15841660|NCT04110288|Device|Non-drug coated Device Treatment|
15841661|NCT04110275|Drug|Recombinant human tissue-type plasminogen activator derivative|Recombinant human tissue-type plasminogen activator derivative(rPA,chemical name: Reteplase,brand name:Ruitongli) 18mg/10ml/stick, provided by AngDe Biotech Pharmaceutical Co.,LIMITED(LTD)
15841662|NCT04110275|Drug|Recombinant human tissue-type plasminogen activator|Recombinant human tissue-type plasminogen activator(rt-PA,chemical name:Alteplase,brand name: Actilyse)50mg/stick,provided by Boehringer Ingelheim Pharma Gesellschaft mit beschrankter Haftung(GmbH)&Co,
15841663|NCT04110262|Other|High dietary sodium intake|Twenty five day feeding period of high dietary sodium (3400 mg/day)
15841664|NCT04110262|Other|Low dietary sodium intake|Twenty five day feeding period of low dietary sodium (2300 mg/day)
15841667|NCT04110236|Behavioral|PriCARE|PriCARE is a group caregiver training program designed to improve child behaviors, caregiver-child relationships, parenting capacity, and reduce caregiver stress. Sessions occur in the primary care clinic or virtually. PriCARE uses the 3 P skills (Praise, Paraphrase and Point-out-Behavior). The training starts with skills on giving attention to children's positive, pro-social behaviors, while ignoring minor misbehaviors. The second part of the training teaches skills for giving effective commands in order to set age-appropriate limits and increase compliance. PriCARE includes a stress education section that contextualizes the use of these skills with the types of behaviors and problems exhibited by many children living with psychosocial adversity and familial stress. Caregivers are encouraged to practice the skills with their child in between sessions. Since PriCARE's initial and successful pilot, the intervention has been enhanced in order to increase engagement and effectiveness.
15841668|NCT04110236|Behavioral|Positive Discipline Module|The PriCARE Positive Discipline Module is a pilot group caregiver training program designed to teach caregivers positive discipline techniques, including appropriate timeout procedures. The sessions are offered in the primary care setting or virtually. This training will supplement the content of the main PriCARE intervention and provide caregivers with skills for addressing difficult behaviors not reduced through positive attention and strategic ignoring. This module will be offered to a subset of CHOP participants who were randomized to the intervention arm, successfully completed the main study interviews, and attended at least 4 out of the 6 PriCARE sessions.
15841669|NCT04110223|Genetic|next generation sequence|targeted NGS of patients' pretreatment tumor biopsy samples using a 474-gene panel, which covers cancer- and radio-sensitivity-related mutations and SNPs.
15841670|NCT04110210|Drug|Bilateral Ultrasound-Guided Erector Spinae Plane Block|Following skin sterilization and local anesthetic infiltration of the superficial tissues, an echogenic 22-G block needle is inserted in-plane to the ultrasound beam in a cranial-to-caudal direction until contact was made with the transverse process. Correct location of the needle tip in the fascial plane deep to erector spinae muscle is confirmed by injecting 0.5-1 ml saline and seeing the fluid lifting the erector spinae muscle off the transverse process while not distending the muscle. A total of 20ml bupivacaine 0.25% are then injected into the ESP. The procedure is repeated on the contralateral side.
15841671|NCT04110210|Drug|Morphine Consumption|After operation, patients will be transferred to post anesthesia care unit (PACU) for complete recovery and monitoring. The pain VAS scores between the studied groups will be registered every 4 hours for 24 hours postoperatively. A standard postoperative analgesia regimen will be prescribed as paracetamol 1gm every 6 hours and ketorolac 30mg every 8 hours in the first 24 hours postoperatively. Morphine 2.5 mg will be given as a rescue analgesic dose if visual analogue score was ≥ 3 or when patient suffering from pain between the assessment intervals in both groups not exceeding 0.1 mg/kg in a period of 6 hours. Metoclopramide 0.15 mg/kg IV will be prescribed for patients complaining of nausea or vomiting.
15841672|NCT04110184|Other|Systemic lupus erythematosus disease activity index (SLEDAI)|The SLEDAI score ranges between 0 and 105, and scores ≥8 represent active disease
15841673|NCT04110145|Drug|Linaclotide|Single dose, once daily at approximately the same time each day, 30 minutes before any meal
15841674|NCT04110145|Drug|Placebo|Single dose, once daily at approximately the same time each day, 30 minutes before any meal
15841675|NCT04110132|Procedure|Ganglion impar block with Bupivacaine.|"Bupivacaine group; Ganglion Impar will be blocked using G25 Quinqe spinal needle using Bupivacaine 0.5% 10ml.
~Postoperative VAS will be measured each 1 for the first 6 hours then at 9 and 12 hours postoperative."
15841676|NCT04110132|Procedure|Ganglion impar block with normal saline|Saline group; Ganglion Impar will be blocked using G25 Quinqe spinal needle using Normal Saline 10ml Postoperative VAS will be measured each 1 for the first 6 hours then at 9 and 12 hours postoperative.
15842481|NCT04103684|Drug|Dexamethasone|0.6mg per kg perday for 5 days
15841680|NCT04110093|Drug|Regorafenib and PD-1 inhibitor|All Colorectal cancer patients received regorafenib (80mg qd d1-d21,q4w) and PD-1 inhibitor. The patients could receive one type of PD-1 inhibitors according to oneself circumstance consideration including nivolumab (3mg/kg, ivgtt, q2w), Carelizumab (200mg, ivgtt, q3w), Sintilimab (200mg, ivgtt, q3w), Toripalimab(240mg ivgtt, q3w).
15841681|NCT04110080|Procedure|multimodal pain management|Regional anesthesia techniques, specifically rectus sheath and transabdominal plane blocks, for pain management will be performed.
15841682|NCT04110080|Other|goal directed fluid management|Intraoperatively fluids will be administered based on hemodynamic parameters, in addition to clinical judgement.
15841683|NCT04110080|Other|preoperative carbohydrate loading|Patient's nutrition will be optimized preoperatively by administering carbohydrate drinks, and limiting fasting time.
15841684|NCT04110080|Procedure|Donor nephrectomy|All patient will have laparoscopic nephrectomy procedure with transplant surgery.
15841685|NCT04110080|Procedure|regional anesthesia|transabdominal plane and rectus sheath nerve block
15841686|NCT04110067|Other|Small Incision Lenticule Extraction (SMILE) with Visumax (Carl Zeiss Meditec, Jena)|Creation of a corneal tissue disk called lenticule and extraction through a minimally invasive incision, utilizing only a femtosecond laser
15841687|NCT04110054|Drug|S-600918|Tablets for oral administration
15841688|NCT04110054|Drug|Placebo to S-600918|Tablets for oral administration
15841689|NCT04110041|Behavioral|Aerobic Exercise|Thrice-weekly aerobic exercise sessions lasting ~45 minutes, for 12 consecutive weeks.
15841690|NCT04110028|Drug|Nicotinamide riboside|Nicotinamide riboside in different doses
15841691|NCT04110028|Drug|Placebo|Placebo
15841692|NCT04110015|Device|virtual visual field|Patients with identified conditions will be invited to do a virtual visual field test with virtual reality headsets.
15841693|NCT04110002|Behavioral|Injury Prevention Program|
15841694|NCT04109989|Device|HominisTM Surgical System|Trans-vaginal gynecological procedures
15841695|NCT04109976|Drug|Bimekizumab|Study participants will receive bimekizumab at pre-specified time points.
15841696|NCT04109963|Device|Remote ischemic conditioning|Remote ischemic conditioning therapy to the upper arm will be delivered by an automated device (RIC VCI) manufactured by Seagull Aps (Denmark).
15841697|NCT04109950|Drug|SEP-363856|SEP-363856 25mg, 50mg, 75mg, 100mg tablet flexibly dosed once daily
15841698|NCT04109937|Radiation|External beam radiation therapy|The post-operative radiation will cover entire prosthesis/surgical fixation device and will consist of the dose fractionation of: 20 Gy in 5 fractions or 30 Gy in 10 fractions.
15841699|NCT04109924|Drug|Irinotecan|Given IV
15841700|NCT04109924|Biological|Bevacizumab|Given IV
15841701|NCT04109924|Drug|Trifluridine and Tipiracil Hydrochloride|Given PO
15841702|NCT04109911|Dietary Supplement|Fermented oyster extract|Fermented oyster extract 1,200 mg/day for 12 weeks
15841703|NCT04109911|Dietary Supplement|Placebo|Placebo
15841704|NCT04109898|Device|Supraglottic airway device (I-gel) insertion|Modified I-gel insertion technique believed to be easier and non traumatic in anaesthetised patients.
15841705|NCT04109885|Drug|Paracervical injection|1.5 mL of 0.5% bupivacaine will be will be injected bilaterally in the paraspinal musculature of the cervical spine.
15841706|NCT04109885|Drug|prochlorperazine and diphenhydramine.(Standard Treatment)|Intravenous administration of prochlorperazine and diphenhydramine.
15841707|NCT04109872|Drug|Lenalidomide|Lenalidomide effectiveness and tolerability data analysis, that will be retrospectively collected until the 30 of April 2018.
15841708|NCT04109859|Drug|Saline|When using saline, if found mean arterial pressure <65mmHg, Cardic Output>4L/min, Sequential Vascular Response<800 (dyne×sec)/cm, starting dose of norepinephrine 0.04ug/min/kg
15841709|NCT04109859|Drug|Methylene Blue|Patients in the methylene blue group were given methylene blue before anesthesia and continued intraoperative pumping
15841710|NCT04109846|Other|Non-euploid embryo transfer|Other than choice of embryo for transfer, all other medical interventions will be at discretion of treating provider
15841711|NCT04109846|Other|Euploid Transfer|Standard of Care Protocol
15841712|NCT04109833|Drug|ABT|any antibiotic therapy in the first week of life
15841713|NCT04109820|Dietary Supplement|MitoQ|Oral; 20mg once a day for 14 days
15841714|NCT04109807|Other|Ozone|ozone exposure
15841715|NCT04109807|Other|FA|Filtered air exposure
15841716|NCT04109794|Procedure|E-CTG|Envelope connective tissue graft
15841717|NCT04109781|Procedure|Microscope assisted discectomy|Microdiscectomy
15841718|NCT04109768|Behavioral|nutrition and activity|16 sessions; nutrition 8; activity 8- 45 minutes to improve health and nutrition literacy
15841719|NCT04109755|Drug|Pembrolizumab|5x5 Gy radiotherapy in 1 week, 4 cycles of Pembrolizumab (200 mg every three week), surgery
15841720|NCT04109742|Drug|phosphatidylcholine-curcumin complex supplement|a dietary curcumin supplement given at two different doses
15841721|NCT04109742|Drug|Placebo curcumin capsule|matching placebo to active curcumin capsules
15841722|NCT04109729|Drug|Nivolumab|"Nivolumab 480mg IV every 4 weeks for up to 2 years
~• Radium-223 55 kBq/kg IV q4 weeks for 6 cycles total"
15841723|NCT04109716|Behavioral|Interpersonal Psychotherapy - Adolescent Skills Training|This is an indicated group depression prevention consisting of 2 individual pre-group sessions, 8 weekly group session, and up to 6 individual booster sessions. IPT-AST will be delivered predominately through telehealth.
15841724|NCT04109716|Behavioral|Services as usual|Services as usual is expected to be brief periodic sessions (in person or remote) with the school counselor or services in the community.
15841725|NCT04109703|Device|High Level Pulsed Heat delivered by Generation 5 devices from Soovu Labs Inc.|The Soovu Labss Inc. battery powered device is a one inch diameter heating pod that attaches to the user via a ring system. The device may be programmed to deliver a wide variety of treatment algorithms. Control of the devices are through a phone-based bluetooth connection. For this study the treatment algorithm used for subjects in this arm (experimental) used a temperature that was ramped from skin temperature to a peak temperature of 45° C and cycled for 30 minutes.
15841829|NCT04108754|Other|microangiopathic burden|to determine the value of the global microangiopathic burden on the prediction of early stroke risk in a homogeneous cohort of TIA.
15842554|NCT04103021|Device|Port-A-Cath|Totally implanted central venous access device
15841726|NCT04109703|Device|Low Level (37 degrees C) delivered by the control device Generation 5 devices from Soovu Labs Inc.|The Soovu Labs Inc. battery powered device is a one inch diameter heating pod that attaches to the user via a ring system. The device may be programmed to deliver a wide variety of treatment algorithms. Control of the devices are via a phone-based bluetooth connection. For this control arm of the study the treatment algorithm held a steady temperature of 37 degrees C for a 30 minute period.
15841727|NCT04109690|Drug|CPX-351|Patients in both Phase I and II can receive a maximum of two induction and six consolidation cycles on an inpatient or outpatient basis per local hospital standard of care.
15841728|NCT04109664|Procedure|laparoscopic sleeve gastrectomy|The greater omentum is carefully dissected from the stomach at a distance of 2cm for the patients with AR, and 6cm for patients with AP. The omental dissection was performed using 5mm-abdominal ligature (Ligasure®, Metronic-Covidien, Minneapolis, USA), from the antrum towards the angle of His. Transection from the omentum is continued until the left crus has been identified. All sleeves are transected using 36 French orogastric tubes. Green cartridges (4.8 mm staple height) are used for the first firing and blue cartridges (3.5 mm) for the rest. Neither oversewing sutures to the staple line nor staple line reinforcement products are used. Homeostatic metallic clips are used for bleeding at the staple line. If bleeding persists and cannot be controlled, an interrupted suture is performed at the point of bleeding. A leak test with methylene blue is performed to the gastric remnant to assess the integrity of the suture line.
15841729|NCT04109651|Other|Nursing intervention|"Nursing Intervention: This intervention was planned based on Meleis' Transition Theory. So it includes individual counseling and training.
~In the Health Promotion Monitoring Program; three training modules and one reminder module were implemented and telephone counseling was provided. Various training tools were used in these trainings. Three different power point presentations were made during the training sessions. Illustrated printed training material was used. At the end of the training, training booklet was given to the participants."
15841730|NCT04109638|Device|Endonovo SofPulse|The active device emits PEMF signal whereas the placebo device does not emit a PEMF signal. The active device is on for 15 minutes at a time, every two hours, for 10 days.
15841731|NCT04109625|Diagnostic Test|Démonstrateur MAGIA|test of capillary blood with the demonstrator at two time and 2 measures and 2 finger by subject.
15841732|NCT04109599|Behavioral|PlaySmart|Participants will play the developed PlaySmart game over a 6-month period.
15841733|NCT04109586|Behavioral|Personalized nutritional therapy|Dietitian led assessment and individual nutritional therapy during inpatient rehabilitation with follow-up the first year after injury
15841734|NCT04109573|Procedure|high resolution anal manometry|functional studies before and after anal laser ablation
15841735|NCT04109547|Drug|Oral semaglutide|Tablets to be taken once-daily for 26 weeks
15841736|NCT04109547|Drug|Placebo|Tablets to be taken once-daily for 26 weeks
15841737|NCT04109534|Diagnostic Test|Bronchial allergen provocation (BAP)|Nebulized Dermatophagoides farina administered at following doses: 10AE, 20 AE, 40 AE, 80 160 AE, etc… until the FEV1 decreases 20% below the initial FEV1-value
15841738|NCT04109534|Diagnostic Test|Nasal provocation test (NPT)|Dermatophagoides farina will be administered in both nostrils
15841739|NCT04109534|Diagnostic Test|Methacholine test|Nebulized metacholine will be administered at following doses: 0,01mg, 0,1mg, 0,4mg, 0,8mg und 1,6mg until the FEV1 decreases 20% below the initial FEV1-value
15841740|NCT04109534|Diagnostic Test|Peak nasal expiratory flow (PNIF)|Comparison of peak nasal expiratory flow (PNIF) after NPT between groups
15841742|NCT04109508|Drug|Oral semaglutide|Oral semaglutide current formulation and oral semaglutide new formulation, each in 3 different strengths, administered once daily during 6 treatment periods, each lasting 12 weeks
15841743|NCT04109495|Other|Smart phone application(NOOM)|The study population included first diagnosis of pancreatic cancer patients within 3 months of pancreatic cancer center visit, and randomly assigned to the use of Noom user group and non-use group. A total of 40 patients, 20 from each group, were used to examine nutritional status(PG-SGA), blood index analysis, and quality of life(EORTC QLQ) at 0, 4, 8, and 12 weeks. At the same time, the patients voluntarily record meals and receive feedback using Noom. The purpose and contents of this study are explained in detail to the subjects, and written consent is obtained. The questionnaire items included gender, age, weight, type of diagnosed digestive disease, treatment method, nutritional supplement, oral status and intake of oral supplement foods, and past medical history. To assess the nutritional status using laboratory data, blood(about 8ml) is collected for each visit.
15841744|NCT04109495|Other|Non-user|The patients dose not use Noom application. A total of 40 patients, 20 from each group, were used to examine nutritional status (PG-SGA), blood index analysis, and quality of life (EORTC QLQ) at 0, 4, 8, and 12 weeks. The purpose and contents of this study are explained in detail to the subjects, and written consent is obtained. The questionnaire items included gender, age, weight, type of diagnosed digestive disease, treatment method, nutritional supplement, oral status and intake of oral supplement foods, and past medical history. To assess the nutritional status using laboratory data, blood (about 8ml) is collected for each visit. At each visit, you will be assessed nutritional status and quality of life through the PG-SGA and EORTC QLQ.
15841830|NCT04108741|Device|C-Mill augmented reality treadmill training|PD Patients will be randomized to treadmill training with augmented reality or to treadmill training with random number generation or to treadmill training for 3 weeks at 5 days a week for 30 minutes.
15841831|NCT04108728|Diagnostic Test|BRIEF SCORE AT INCLUSION|BRIEF SCALE evaluation
15841960|NCT04107779|Other|Switch from UB of Combustible Cigarette to JUUL 3% Mango ENDS|JUUL 3%, ENDS for 6-days in confinement
15841745|NCT04109482|Biological|MB-102|"The study drug, MB-102 consists of adoptively transferred T cells that are genetically modified using a self-inactivating (SIN) lentiviral vector to express a CD123-specific, CD28-costimulatory chimeric antigen receptor (CAR) as well as a truncated human epidermal growth factor receptor (EGFRt) (CD123.CD28.CD3ζ.EGFRt+T cells) derived from autologous leukapheresis which is administered after a lymphodepletion regimen.
~Single dose of MB-102 up to 600 x 10 6 CART-T+ cells (Day 0) as defined by Phase 1 will be administered."
15841746|NCT04109482|Drug|Fludarabine|"Fludarabine 30 mg/m2/day IV (3 days) on days -5, -4, and -3
~A 20% dose reduction (24 mg/m2/day IV (3 days) on days -5, -4, and -3) is required for patients with moderately impaired renal function (creatine clearance ≤ 70 mL/min)."
15841747|NCT04109482|Drug|Cyclophosphamide|Cyclophosphamide 300 - 500 mg/m2/day IV (3 days) on days -5, -4, and -3
15841748|NCT04109469|Device|Shark Screw® transplant|Application of a Shark Screw® transplant for osteosynthesis or arthrodesis in hand- or foot surgery
15841749|NCT04109456|Drug|IN10018|100 mg, orally once daily continuously
15841750|NCT04109456|Drug|Cobimetinib|60mg , orally once daily from day 1 to day 21 in a 28-day cycle
15841751|NCT04109443|Behavioral|Young Men & Media Program|The online sexual health media literacy website includes content about (1) male anatomy; (2) HIV/STI prevention; (3) overall sexual health; and (4) sexually explicit online media (SEOM) literacy.
15841752|NCT04109443|Behavioral|Available websites on safe sex and preventing STIs|Available websites (such as by the CDC) that provide information about sexual health and preventing sexually transmitted infections (STIs) including HIV.
15841753|NCT04109417|Procedure|osteotomy filled with PRP-gel and covered with PRP-biomembrane|
15841754|NCT04109417|Procedure|osteotomy site following the surgical intervention was left empty|
15841755|NCT04109391|Biological|TX05 (trastuzumab)|Subjects will receive up to 13 cycles of adjuvant treatment.
15841756|NCT04109391|Biological|Herceptin (trastuzumab)|Subjects will receive up to 13 cycles of adjuvant treatment.
15841757|NCT04109378|Procedure|Surgical procedures( conventional laparoscopic and NOSE technique) for the treatment of colorectal DIE|For conventional laparoscopic and NOSE techniques a 4-port approach is used. The rectum is skeletonized. The distal rectum is closed using an endoscopic linear stapler. The mobilized rectum with the specimen is retrieved through a small suprapubic incision. The anvil of a conventional circular stapler is introduced in the proximal colon after placement of a purse string suture. A circular stapled colorectal anastomosis is fired. In case of NOSE, both the proximal sigmoid colon and the proximal rectum are tied off laparoscopically with a nonabsorbable suture. A transverse colotomy is performed in healthy tissue using a harmonic scalpel to deliver the anvil from a circular stapler introduced through the anus. The specimen is extracted transrectally in a specimen retrieval bag. Proximal part of the anastomosis is completed by suturing the anvil in place with a laparoscopic suture. The distal rectum is closed using a linear stapler. End-to-end anastomosis is made using the circular stapler
15841758|NCT04109365|Diagnostic Test|Electrical Epidural Stimulation Test (EST)|EST measures sensory/motor responses
15841759|NCT04109339|Drug|Oxytocin|During the laparoscopic hysteromyomectomia operation, different doses of oxytocin was used with different routs.
15841760|NCT04109326|Other|APAD|"8 PA sessions supervised at the hospital centers and 44 unsupervised home sessions, to be performed twice a week.
~6 consultations for nutrition education to teach the principles of well balanced diet, to foster weigh control during treatment, and to induce appropriate feeding behaviors after treatment."
15841761|NCT04109313|Drug|LOU064|selected dose of LOU064 taken orally twice a day (morning and evening) from day 1 to week 52 of the Treatment period.
15841762|NCT04109300|Genetic|HLADQA1*05A>G screening|DNA will be extracted from whole blood collected from subjects in both arms using the MagNA Pure Compact instrument (Roche, Laval, Quebec, Canada). A custom TaqMan allelic discrimination assay (Applied Biosystems, Carlsbad, CA) will be used to determine the presence of wild-type and/or variant alleles in the class II HLA gene region at rs2097432 mapped to the HLA-DQA1*05 region in infliximab-exposed IBD subjects. Genetic data will be used to determine whether or not one of methotrexate or azathioprine should be applied to the patient in the experimental arm.
15841763|NCT04109300|Other|Standard of Care|The treating physician will use clinical judgement to determine need for the addition of one of methotrexate or azathioprine to infliximab therapy.
15841764|NCT04109287|Device|REVITIVE® device|The REVITIVE® device applies neuromuscular electrical stimulation to the soles of the feet, causing the muscles of the leg to contract and relax, thus improving blood circulation through the legs.
15841765|NCT04109274|Behavioral|Exercise|Exercise component: Aerobic exercise, using recumbent bikes, delivered within the cancer institution. Participants will take part in up to 30-minutes of moderate intensity (50-70% HRmax or 4-6/10 on Rate of Perceived Exertion scale)6 exercise for eight sessions during chemotherapy. An exercise specialist with experience in cancer rehabilitation will supervise the exercise component.
15841766|NCT04109274|Behavioral|Self-Management|Eight SM modules will be delivered to participants. They will be viewed on an iPad prior to or after the exercise component. The goal of these modules is to aid participants in developing physical activity goals and action plans to continue with between sessions, with an overarching goal of helping them reach exercise guidelines for cancer survivors and the Canadian Physical Activity Guidelines
15841767|NCT04109274|Behavioral|Booster Sessions|Four booster sessions will be provided to participants in this group. These will occur at 2, 4, 6, and 8 months post intervention completion. An assessor trained in behavioural counselling will provide booster sessions by phone and will discuss the individuals physical and emotional condition, current exercise level, accomplishment of previously set goals and action plans, and perceived barriers to participation in exercise. The assessor will use facilitation strategies to aid participants in devising strategies to overcome barriers and set realistic goals and action plans.
15841768|NCT04109261|Drug|Palbociclib|Palbociclib administration in breast cancer patients included in a compassionate use programme. Patients were treated according to the standard of care
15841852|NCT04108559|Other|Control Group|Routine third molar extraction will be performed. No extra procedures will be done after surgery.
15841961|NCT04107779|Other|Switch to Dual-use of JUUL 5% and UB of Combustible Cigarette|Combination use of JUUL 5% (Virginia Tobacco, Mint, Menthol or Mango flavored) and usual brand combustible cigarettes for 6-days in confinement
15841962|NCT04107779|Other|Tobacco/Nicotine Abstention|No smoking for 6-days in confinement.
15841963|NCT04107779|Other|Usual Brand of cigarettes|Continue smoking UB for 6-days in confinement.
15841769|NCT04109235|Other|High-Intensity Interval Training Physical Activity (PA) Advice|This PA intervention will be primarily self-directed by the patients themselves. Each participant will receive a 1-page double-sided handout detailing their PA protocol. Participants in this arm will receive a High-Intensity-Interval-Training (HIIT) handout (developed based on research from Dr. Martin Gibala) detailing their PA recommendations. Participants will be instructed to follow their PA protocol, while noting down which days they completed the PA using a log booklet provided to them by Dr. Fernando (their family physician). Participants will be provided with the phone number for Justine Horne who is a lifestyle coach and co-investigator on this trial. If participants have questions about their PA protocol, Justine will respond to these over the phone.
15841770|NCT04109235|Other|Population-Based Physical Activity (PA) Advice|This PA intervention will be primarily self-directed by the patients themselves. Each participant will receive a 1-page double-sided handout detailing their PA protocol. Participants in this arm will receive a CSEP handout (page 4&5 from: http://csep.ca/CMFiles/Guidelines/CSEP_PAGuidelines_0-65plus_en.pdf) detailing their PA recommendations.Participants will be instructed to follow their PA protocol, while noting down which days they completed the PA using a log booklet provided to them by Dr. Fernando (their family physician). Participants will be provided with the phone number for Justine Horne who is a lifestyle coach and co-investigator on this trial. If participants have questions about their PA protocol, Justine will respond to these over the phone.
15841771|NCT04109222|Biological|Fluzone Quadrivalent vaccine, no preservative (0.5-mL), 2019-2020 formulation|Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
15841772|NCT04109222|Biological|Fluzone High-Dose vaccine, 2019-2020 formulation|Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
15841773|NCT04109209|Behavioral|Psychosocial Intervention Group|The intervention will consist of six one-on-one sessions (45 minutes each). Complete 3 questionnaires: Baseline, 11 weeks, 16 weeks
15841774|NCT04109209|Behavioral|Usual Care Group|"Caregivers randomized to the usual care arm will be referred to the brain tumor clinic social worker or other appropriate cancer center resources upon request from the caregiver, patient or clinician
~•Complete 3 questionnaires: Baseline, 11 weeks, 16 weeks"
15841775|NCT04109196|Behavioral|Cognitive Processing Therapy|Cognitive Processing Therapy is an evidence-based treatment for PTSD that will be delivered intensively twice per day over the course of five days.
15841776|NCT04109183|Drug|The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.|The subjects were randomized to the treatment group of 3TC or different doses of FNC. The background drugs were EFV and TDF.
15841777|NCT04109157|Diagnostic Test|20-minute pad test|Our 20-minute modified pad test was described previously proposed first by Hahn and Fall and modified by Sand and Ostergard. Each patient's bladder was emptied with a transurethral catheter and filled to the SD amount of sterile water for test. The catheter was removed, and then the patient returned to a standing position with a pre-weighed perineal pad placed on the underwear. The patient was asked to cough 10 times, bear down 10 times, do 10 deep knee bends, jump up and down on the spot 10 times, wash her hands under cold water for 1 minute, walk up and down five stairs 10 times, walk in the hall for 10 minute, and then return for removal of the pad. The pad was then weighed and the net weight was calculated by subtracting from the original dry weight to achieve a measure of the total urine loss during the 20 minute exercise. The pad weight was measured in grams and the accuracy of the scale was 1 gram. The positive pad weight result was defined as more than 1 gram of leakage.
15841778|NCT04109144|Biological|Fresh Frozen Plasma (FFP)|FFP will be used as a substitute for albumin during the 2nd of 3 total paracentesis being monitored
15841779|NCT04109144|Biological|Albumin|Albumin will be used during the 1st and 3rd paracentesis
15841780|NCT04109144|Procedure|Large Volume Paracentesis (LVP)|All participants who have this procedure, meet eligibility criteria and who consent
15841781|NCT04109131|Other|Samples collection: Plasma|"At baseline
~Part A:
~TNBC/ HER2+ BC: once a year
~NSCLC/SCLC: every 4 months
~Melanoma: every 6 months
~Part B:
~o As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis
~Part C:
~o Every 3 months (+/- 1 month)"
15841782|NCT04109131|Other|Samples collection: CSF|Part B: Mandatory CSF sampling at CNS diagnosis when clinically possible unless medically contra-indicated - As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis Part C: Additional CSF sampling in case CSF sampling is performed for routine clinical practice
15841783|NCT04109131|Other|Samples collection: Non-CNS Metastatic Tumour Tissue|Part B: Highly recommended non-CNS metastatic tumour tissue collection (1FFPE and 1 FT) at CNS metastases diagnosis (Part B) (NB: Bone lesions are excluded) - As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis
15841784|NCT04109131|Other|Brain MRI|"Part A:
~Brain MRI at inclusion is allowed within 45 days before enrolment
~Brain MRI pre-CNS diagnosis (Part A) : HER2 BC/TNBC: once a year; NSCLC/SCLC: every 4 months; Melanoma: every 6 months (+/- 1 month)
~Part B:
~o As close as possible to the diagnosis of CNS metastases and no later than 6 weeks after diagnosis
~Part C:
~o Brain MRI post-CNS diagnosis (Part C): every 3 months (+/- 1 month window)"
15841785|NCT04109118|Behavioral|Distress Tolerance - Benzodiazepine Discontinuation (DT-BD)|Distress Tolerance - Benzodiazepine Discontinuation (DT-BD) is a psychosocial intervention. It is paired with a benzodiazepine taper. The aim of the psychosocial intervention is to improve individuals' ability to tolerate distress in order to assist benzodiazepine discontinuation in patients treated with OAT. There will be 3 sessions between therapist and participant prior to the start of the benzodiazepine taper. The taper for both the intervention and control conditions occurs over 9 weeks and involves weekly meetings with a benzodiazepine prescriber during which a gradual benzodiazepine dose reduction will take place. The DT-BD intervention combines elements of existing psychosocial interventions. Specifically, interoceptive exposure techniques will be paired with elements of acceptance and commitment therapy (ACT) and relapse prevention (RP).
15841887|NCT04108273|Behavioral|Waitlist|Will undergo two magnetic resonance imaging (MRI) sessions separated by a 12 week wait period. Will then undergo OST treatment
15841888|NCT04108260|Drug|Albutrepenonacog Alfa 1 UNT [IDELVION]|Clinical data will be collected from patients who suffered from hemophilia B, and switch from other FIX products to Idelvion as prophylaxis, prevention of bleeding (e.g. surgery) or treatment of bleeding.
15841889|NCT04108247|Drug|Abiraterone+SHR3162|Participants will receive Abiraterone combined with SHR3162 orally
15841890|NCT04108234|Drug|HR071603|HR071603 monotherapy ,nasal spray
15841786|NCT04109118|Drug|BZD discontinuation protocol|All participants will undergo BZD discontinuation. Once the starting BZD dose is determined by prescription monitoring and/or self-report, we will maintain participants on this dose until the start of the BZD taper. Participants will see a study physician weekly to receive their BZD medication for the week until the taper is completed. BZD discontinuation in this study will consist of a gradual BZD taper in dose over 8 weeks. The taper will be flexible in that the study physician will utilize clinical judgement to lengthen the taper if necessary, depending on the severity of the participant's withdrawal symptoms. Anchor points will be set (33% reduction in dose after 2 weeks, 50% mid-treatment, 100% by week 8) to emphasize the time-limited nature of the taper.
15841787|NCT04109105|Other|NHS-PEG coated collagen patch|Analysis of the number and seriousness of leaks in the ileocolic anastomosis after using a NHS-PEG coated collagen patch reinforcement.
15841788|NCT04109092|Drug|E7766|E7766, solution, intravesically.
15841799|NCT04109040|Device|slit lamp|diagnostice device to examine anterior segment of the eye and for fundus examination
15841800|NCT04109027|Behavioral|BrainStrong-GSR|Goal-directed State Regulation Training (GSR)
15841801|NCT04109027|Behavioral|BrainStrong-OPT|Optimization of Brain Functioning (OPT)
15841802|NCT04109014|Other|FASTLANE II|"The intervention will consist of nine weekly hour-long individual counseling sessions. The FL II sessions utilize a combination of Cognitive Behavioral Therapy (CBT) and Motivational Interviewing (MI) to reduce sexual risk behaviors and mental health symptoms. Thus, individuals develop a toolbox for mood self-management to improve emotional self-regulation and reduce maladaptive coping mechanisms to minimize drug and sex risk behavior. Participants will be considered as completing the FASTLANE Intervention upon completion of the nine weeks of sessions."
15841803|NCT04108988|Behavioral|InvestiDate|Participants will be randomly assigned to play either InvestiDate (n=40), or the non-health related attention and time control condition multiplayer videogame (n=40).
15841804|NCT04108988|Other|Non-Health Related Video Game|Participants will be randomly assigned to play either InvestiDate (n=40), or the non-health related attention and time control condition multiplayer videogame (n=40).
15841805|NCT04108975|Procedure|Rectus muscle reapproximation during CS|Reapproximation by 3 interrupted simple sutures or 3 vertical mattress sutures.
15841806|NCT04108975|Procedure|Rectus muscle non reapproximation during CS|During CS rectus muscle non reapproximation will be done.
15841807|NCT04108962|Drug|Fasenra, 30 Mg/mL Subcutaneous Solution|Anti-IL5 receptor alpha monoclonal antibody
15841808|NCT04108949|Behavioral|Tuning in to Kids|A psychosocial intervention focusing on emotion socialization and emotion coaching.
15841809|NCT04108949|Behavioral|Treatment as usual|See description included in arm/Group description.
15841810|NCT04108923|Device|Ligasure|the vessel sealing device ( ligasure covidien ) which seals vessels by fusing the inner layers of the vessel wall
15841811|NCT04108923|Procedure|Conventional vessel ligation|Conventional vessel ligation either tying and /or clipping of blood vessels
15841812|NCT04108910|Diagnostic Test|Guidance UTI|
15841813|NCT04108897|Drug|Doxycycline|The investigators will administer doxycycline to rosacea patients according to the dose of patients' assigned study arm.
15841814|NCT04108897|Drug|Ivermectin Topical|1% topical ivermectin.
15841815|NCT04108884|Device|App measurement|App measurement twice a day in the first two weeks after enrollment and twice a week (on different days) from the third week onward and whenever patients feel palpitations
15841816|NCT04108884|Device|14 day Holter ECG|14 day moblie patch Holter ECG for AF confirmation
15841817|NCT04108871|Procedure|Prostate Biopsy|Samples of tissue are removed from the prostate for histopathological diagnosis of prostate cancer through the use of a needle with the assistance of transrectal ultrasound.
15841821|NCT04108845|Biological|15-Valent Pneumococcal Conjugate Vaccine|3/1 dose(s) according to age of subjects. Single intramuscular dose contains 0.5ml 15-Valent Pneumococcal Conjugate Vaccine.
15841822|NCT04108832|Drug|TCM OA2|Usage: 3g twice daily
15841823|NCT04108832|Drug|PLACEBO|Usage: 3g twice daily
15841824|NCT04108819|Dietary Supplement|Ketogenic Diet|Subjects will undergo ketogenic diet at a 2.5:1 (fat: carb + protein) ratio for a 2-week period.
15841825|NCT04108806|Procedure|Endovascular therapy|Ballon dialtation of the diseased artery
15841826|NCT04108793|Other|Physiotherapy exercises|The intervention group will receive an extended home-based rehabilitation program twice a week continued for 3 months (12 weeks) after discharge funded by the study.
15841827|NCT04108780|Device|T-tube|T shaped tube used as stent after CBD exploration
15841828|NCT04108767|Behavioral|Answer to standardized questionnaires in quality of life, health, lifestyle and behaviors|"The cross-sectional study will be conducted in all students in health sciences in 3rd year enrolled at the University Claude Bernard Lyon 1 (UCBL) and participating at the required medical consultation at the college Health Department of UCBL, over a period of 9 months.
~The self-questionnaires will be completed by the students during the mandatory medical preventive visit at the university health center.
~All dimensions investigated by the questionnaire are usually questioned by the caregivers during the consultation as part of the usual follow-up of students."
15841832|NCT04108715|Procedure|Erector spina plain block for mastectomy analgesia|After giving general anesthesia, patient is positioned in lateral decubitus with the surgical side up, An erector Spina plain block is performed with inserting block needle (Pajunk, Geisingen, Germany) in-plane under ultrasound control until needle tip hits the transverse process, a volume of 0.3 ml/kg of bupivacaine 0.25% (Marcaine, Astra Zeneca Pharmaceuticals) is injected. Pain management assessment and analgesic consumption will be provided through patient-controlled analgesia (PCA) for 24 hours. The PCA pump is programmed to deliver 1 mg morphine bolus per press with a lockout interval of 10 min. Pain scores will be measured using eleven points numerical rating scale NRS (0 to 10) and opioids consumption will be documented at 0, 1, 4, 8 and 24 hours. Time of admission to post-anesthesia care unit PACU is considered 0 hours. Any opioid equivalents given during the first 24 hours to manage breakthrough pain will be documented
15841833|NCT04108715|Procedure|Deep serratus anterior plane block|After giving general anesthesia, the patient is positioned in lateral decubitus, with the surgical side up. The upper arm is abducted and elevated above the head level. A block needle is introduced in-plane, targeting the plane deep to the serratus anterior muscle, and a bolus of 0.3 ml/kg bupivacaine 0.25% is injected through ultrasound guidance. Pain management assessment and analgesic consumption will be provided through patient-controlled analgesia PCA for 24 hours. The PCA pump is programmed to deliver 1 mg morphine bolus per press with a lockout interval of 10 min. Pain scores will be measured using eleven points numerical rating scale NRS (0 to 10), and opioids consumption will be documented at 0, 1, 4, 8 and 24 hours. Time of admission to PACU is considered 0 hours. Any opioid equivalents given during the first 24 hours to manage breakthrough pain will be documented
15841834|NCT04108702|Device|Virtual reality heart|"Patients will either sit or stand while wearing a head mounted display (HMD, Oculus Rift). A 360° video, showing a neutral body from the back in a neutral room, will be projected onto the HMD.
~We will record the patients' ECG throughout the entire experiment. Raw data (ECG) are acquired with Arduino and in-house software will detect, in real time, the peak of each R-wave from the recorded ECG data and trigger an additional visual stimulus (e.g. a flashing outline surrounding the virtual body) that flashes on and off SYNCHRONOUSLY with respect to the participant's heartbeat. The silhouette surrounding the virtual body flashes for a duration of 100ms and with a sinusoidal opacity."
15841835|NCT04108702|Device|Virtual reality control|"Patients will either sit or stand while wearing a head mounted display (HMD, Oculus Rift). A 360° video, showing a neutral body from the back in a neutral room, will be projected onto the HMD.
~We will record the patients' ECG throughout the entire experiment. Raw data (ECG) are acquired with Arduino and in-house software will detect, in real time, the peak of each R-wave from the recorded ECG data and trigger an additional visual stimulus (e.g. a flashing outline surrounding the virtual body) that flashes on and off ASYNCHRONOUSLY with respect to the participant's heartbeat. The silhouette surrounding the virtual body flashes for a duration of 100ms and with a sinusoidal opacity."
15841836|NCT04108702|Other|Standard therapy|Standard multimodal out-patient therapy program (psychological support, physiotherapy, ergotherapy).
15841837|NCT04108689|Behavioral|I-ACT|An internet-based behavioral psychotherapy intervention to enhance athletic performance in elite ice hockey players.
15841838|NCT04108676|Drug|Fluzoparib|PARP inhibitor
15841839|NCT04108676|Drug|Omeprazole|proton pump inhibitor
15841840|NCT04108663|Behavioral|Effect of tDCS on cognitive control task performance|Added verum or sham tDCS while working on a cognitive control task.
15841841|NCT04108650|Other|Fit & Strong! group|Consistent with the original format of F&S!, the classes met three times per week for 90 minutes each for 8 weeks (24 sessions in total). Each class session consisted of 60 minutes of exercise and 30 minutes of health education. The exercise protocol included 10 minutes of warm-up and cool-down exercises, 20 minutes of low-intensity aerobic exercises, and 20 minutes of lower extremity strengthening exercises. The health education program focused on symptom management and behavioral strategies to increase physical activity and commitment to lifestyle change.
15841842|NCT04108637|Procedure|penicillin allergy assessment pathway|"Summary of penicillin allergy assessment pathway :
~Stage-1 PAAP in Primary Care - Clinical History. Screening, questionnaire and antimicrobial history will be undertaken in primary care Stage-2 Skin Test(ST) in hospital clinic (this may not be needed for all participants) Stage 3 Oral Challenge Test (OCT) in hospital clinic Testing will involve half a day in clinic and then a three-day post clinic course of oral antimicrobial therapy, without a reaction"
15841843|NCT04108624|Other|Screening Phase|This will identify subjects who are MRD (minimal residual disease) negative and eligible for the discontinuation phase.
15841844|NCT04108624|Device|Discontinuation Phase|Patients will undergo discontinuation of their maintenance therapy if they are MRD negative by PET/CT (Positron Emission Tomography/Computed Tomography), flow cytometry and next generation sequencing
15841845|NCT04108611|Procedure|hemodiafiltration with endogenous re infusion (HFR)|hemodiafiltration with endogenous re infusion (HFR) for cases 2
15841846|NCT04108598|Other|Quality of life questionnaire|No intervention will be administered, select sites will administer a quality of life questionnaire
15841847|NCT04108585|Procedure|HFO therapy|HFO therapy from mechanical ventilation
15841848|NCT04108585|Procedure|CPAP therapy|CPAP therapy from mechanical ventilation
15841849|NCT04108572|Behavioral|Infant feeding|Verbally delivered pre-specified infant feeding message. The messages focus on appropriate milk feeding and establishing complementary feeding and solid food introduction in relation to timing and practical guidance around processes of feeding and provision of additional infant-feeding resources including information leaflet, a magnet, an infant bib and access to an informational website.
15841850|NCT04108559|Procedure|Kinesiologic Tape Group|A mucoperiosteal flap will be raised, a conventional rotary handpiece will be used under irrigation for removing the third molar.Primary wound closure will be accomplished using 3-0 silk sutures.The kinesiologic tape will be prepared individually for each patient; it will be cut into three equal strips (approximately 1.6 cm in width) and placed between the clavicle and the tragus-commissura line. The patients will be invited after one week for removing the sutures.
15841851|NCT04108559|Procedure|Drain Group|A mucoperiosteal flap will be raised, a conventional rotary handpiece will be used under irrigation for removing the third molar.Primary wound closure will be accomplished using 3-0 silk sutures. A plastic non-customised drain tube (2-cm long, 2-mm diameter) will be inserted into a vertical incision between the first and second molars and sutured to the vestibular mucosa. The patients will be invited after one week for removing the sutures.
15841891|NCT04108234|Drug|placebo|placebo,nasal spray
15841853|NCT04108546|Device|Electroacupuncture device|The technical characteristics of the device will be: power supply with alkaline batteries (4 pieces), 6V voltage, 6 independently regulated channels, symmetrical biphasic rectangular pulse, excitation from pen type electrode 0.48mA, with high 0.32mA + / -25% & low 0.16mA +/- 25%. Three preset programs to avoid tolerance effect: program 1) 1-6Hz, program 2) 30-100Hz, program 3) 2-100Hz. Low frequencies (2Hz) cause release of endorphins in the brain and enkephalins in the spinal cord, high frequencies (30-100Hz) cause release of dynorphins in the spinal cord, while medium frequencies (15Hz) cause simultaneous release of endorphin and dynorphin. At low frequencies slow diffuse analgesia is achieved with a long duration of analgesic effect, while at high frequencies rapid local analgesic effect of short duration is achieved.
15841854|NCT04108546|Drug|Epidural analgesia|Ropivacaine (Naropeine) 0.2%, 5-7% ml, and Fentanyl 25mcg
15841855|NCT04108533|Behavioral|Text-Based Support|Text-based breastfeeding support as described in arm/group descriptions
15841856|NCT04108520|Other|Exercise|Exercise with respiratory training
15841857|NCT04108507|Procedure|posterior branch block of spinal nerve|posterior branch block of spinal nerve during Percutaneous kyphoplasty(PKP) operation
15841858|NCT04108494|Procedure|Type of omentectomy|Partial omentectomy with preservation of the greater omentum at >3 cm from the gastroepiploic arcade.Control group with total omentectomy.
15841861|NCT04108468|Drug|Golimumab|Simponi
15841862|NCT04108468|Drug|Methotrexate|Methotrexate
15841863|NCT04108455|Other|Specimens Collected|Serum will be collected from patients at multiple times during pregnancy for later analysis.
15841864|NCT04108442|Behavioral|Traditional|Surgeons (rather than individual subjects) will be randomized to traditional Postoperative follow-up modality groups. They will adhere to this form of postoperative follow-up for all of their surgical patients (subjects) for one month.
15841865|NCT04108442|Behavioral|Virtual|Surgeons (rather than individual subjects) will be randomized to virtual postoperative follow-up modality group. They will adhere to that form of postoperative follow-up for all of their surgical patients (subjects) for one month.
15841866|NCT04108429|Behavioral|IntelliCare for College Students|Participants will receive access to the IntelliCare system, which consists of apps with a variety of resources, including lessons and tools designed to teach skills for mood management. It is suggested that participants utilize the mobile phone tools every day
15841867|NCT04108416|Procedure|Cleft lip and palate repair|The intervention is the currently used cleft lip and palate repair technique at the University Hospital Basel and University Childrens Hospital Basel
15841868|NCT04108403|Other|Pain Inducing Massage|A pain inducing massage (pain intensity = 50/100) will be applied for 60 seconds, 4 times.
15841869|NCT04108403|Other|Pain Free Massage|A pain free massage (pain intensity = 0/100) will be applied for 60 seconds, 4 times.
15841870|NCT04108403|Other|Positive Expectation Instructional Set|Participants will be instructed that the massage is effective for some people with neck pain.
15841871|NCT04108403|Other|Negative Expectation Instructional Set|Participants will be instructed that the massage is ineffective for some people with neck pain.
15841872|NCT04108390|Other|Dry needling|For this intervention, the physiotherapist will be placed a needle in the gluteus medius trigger point from 8 to 15 times.
15841873|NCT04108377|Drug|Roflumilast|Roflumilast capsule
15841874|NCT04108377|Drug|Placebo|Sugar pill manufactured to mimic look of Roflumilast capsule
15841875|NCT04108364|Behavioral|Voice adaptive training for aphasia|Training with the VoiceAdapt tablet-based therapy app 25 hours (1 hr/day x 5 days/week x 5 weeks)
15841876|NCT04108351|Other|Road-tracking test|Driving with simulator program for SDLP measurement
15841877|NCT04108351|Other|Car-following test|Intervention Description: Driving with simulator program for DCV measurement
15841878|NCT04108351|Other|Harsh-braking test|Driving with simulator program for BRT measurement
15841879|NCT04108338|Other|Trial setting|Study results from clinical trials usually have been found not work efficiently in clinical practice. This outcome disparity may be caused by different pragmatic features of medical environment, also known as study setting such as trial setting and real-world setting, in which biases inherent to clinical trial design restrict its applicability even though all confounding factors are avoided.
15841880|NCT04108325|Drug|YY-20394|Each treatment cycle is comprised of 28-day consecutive of YY-20394, 80mg QD (days 1 to 28). Upon completion of each cycle, patients may continue to receive oral YY-20394 tablets if there are benefit from the treatment and the toxicity is tolerable.
15841881|NCT04108312|Diagnostic Test|Anatomical MRI Scan|T1-weighted (T1w) magnetization prepared rapid gradient echo (MPRAGE) sequence (TR=8.776 milliseconds, TE=3.656 milliseconds, flip angle=8°, matrix=320x320, 0.8mm3 resolution) and T2-weighted (T2w) CUBE sequence (TR=61.803 milliseconds, TE=3200 milliseconds, flip angle=8°, matrix=320x320, 0.8mm3 resolution)
15841882|NCT04108299|Behavioral|Wait-list control group|For patient participants, they will continue to receive the standard of usual care for their T2D at the CBWCHC during the course of our study. For family/friend participants, they will continue to receive their routine care with their own doctors during the study. At the end of the study, the wait-list control group (both patient and family/friend participants) will be provided the opportunity to receive the counseling videos delivered to them via SMS links.
15841883|NCT04108299|Behavioral|SMS intervention|2-3 SMS-based diabetes videos will be sent to patients each week for 12 weeks (each video within 10 minutes in duration) to both patients and their family members. Patients and their family members will receive the same intervention videos, including basic information about T2D, importance of diabetes self-management at home, behavioral techniques, and family-oriented sessions. BrainShark will be used to determine whether participants view these,videos. For participants who miss 3 consecutive videos, the study team will follow-up with a phone call to identify barriers to watching the video and remind them to review the video.
15841884|NCT04108286|Device|1-DAY ACUVUE MOIST|TEST
15841885|NCT04108286|Device|DAILIES AQUA COMFORT PLUS|CONTROL
15841886|NCT04108273|Behavioral|Organizational Skills Training|Will undergo two magnetic resonance imaging (MRI) sessions: one within 2 weeks prior to OST treatment and one within 2 weeks of completion of the OST treatment.
15841892|NCT04108221|Procedure|laparoscopy or laparotomy withTransversusAbdominis Plane Block|"The US-TAP is performed by the anesthetist under ultrasound control after the end of the procedure of laparoscopy or laparotomy. Under sterile conditions, the anesthetist identifies the oblique abdominal muscles externally, obliquely internally and transversely by ultrasound. A 20 ml needle of 0.5% ropivacaine is injected.
~The surgical TAP (c-TAP) block is performed by the surgeon at the end of the procedure of laparoscopy or laparotomy.The needle and the product used are identical to those of the us-TAP block. The positioning of the needle is in the plane of the fascia between the internal oblique muscle and the transverse muscle, identified by a significant loss of resistance."
15841893|NCT04108208|Drug|Apalutamide|Apalutamide 240 mg (4*60 mg tablets) will be administrated orally once daily.
15841894|NCT04108208|Drug|Placebo|Matching placebo will be administered orally.
15841895|NCT04108208|Drug|Androgen-deprivation Therapy (ADT)|Participants will continue to receive ADT with gonadotrophin-releasing hormone agonists (GnRHa) who have not been surgically castrated.
15841896|NCT04108195|Drug|Daratumumab|Participants will receive daratumumab.
15841897|NCT04108195|Drug|Talquetamab|Participants will receive talquetamab.
15841898|NCT04108195|Drug|Teclistamab|Participants will receive teclistamab.
15841899|NCT04108195|Drug|Pomalidomide|Participants will receive pomalidomide.
15841900|NCT04108169|Procedure|Left atrial appendage occlusion surgery|CABG according to indications in the current guidelines on myocardial revascularization including surgical closure of left atrial appendage
15841903|NCT04108143|Device|MonitorMe|MonitorMe replaces the users existing telephone and for the majority of time is used as their ordinary telephone. At a known and set time of day for 4 weeks, participants will receive an automated MonitorMe telephone call. The participant answers a health and well-being automated script by pressing key pad numbers. At the same time vital signs data are collected. The responses and vital signs data, together with confidence values are then transmitted via telephone lines to an electronic patient record.
15841904|NCT04108130|Other|Preoperative Education|Brochure and video about relevance of postoperative pulmonary complications, postoperative mobilization and use of incentive spirometry.
15841905|NCT04108130|Procedure|Intraoperative PEEP Individualization|PEEP will be set by maximizing respiratory system compliance along a decremental PEEP titration following an incremental recruitment maneuver.
15841906|NCT04108130|Other|Individualization of Neuromuscular Blockade|Administration of neuromuscular blocking agents and their reversal will be done based on established protocol.
15841907|NCT04108130|Procedure|Postoperative Incentive Spirometry|Patients will be encouraged to adhere to incentive spirometry to be started 2 hours after surgery and maintained until patient freely ambulates. Supervision will be provided 3 times/day for continuous education and management of barriers to optimal performance.
15841908|NCT04108130|Behavioral|Postoperative Ambulation|Patients will be encouraged to adhere to prescription of early ambulation.
15841909|NCT04108117|Procedure|Robotic nipple sparing mastectomy|Robotic nipple sparing mastectomy means nipple sparing mastectomy performed using robotic surgical systems.
15841910|NCT04108104|Drug|Cyproheptadine|3-month treatment
15841911|NCT04108104|Drug|Alpress LP|3-month treatment
15841912|NCT04108091|Drug|Treatment for TTR amyloidosis|The usual adult dose is 80 mg of Tafamidis Meglumine orally once daily. The dose may be reduced if not tolerated.
15841913|NCT04108078|Behavioral|Health Policy Pllus (HP+)|HP+ is a stigma-reduction intervention that is designed to reduce stigmatizing attitudes and beliefs among all workers (clinical and non- clinical) in a healthcare facility.
15841914|NCT04108078|Behavioral|Many Men Many Voices (3MV)|3MV is a group-level HIV prevention intervention designed specifically for use with Black men who have sex with men (MSM). It is a 7- session intervention that is facilitated by trained peers. The intervention has previously been adapted and used with MSM in Ghana.
15841915|NCT04108078|Behavioral|HIV Education, Empathy and Empowerment (HIVE3)|The HIVE3 is a telephone-based peer support intervention. It utilizes trained peers, who are also MSM, to provide emotional, informational and affirming support via text message or phone. The intervention was developed specifically for use with MSM in Ghana and demonstrated acceptability and feasibility in a preliminary study in Ghana.
15841918|NCT04108039|Drug|GnRh antagonist|In the antagonist cycle, LH suppression will be accomplished by subcutaneous (SC) injections of 0.25 mg of Cetrorelix or Ganirelix starting in the presence of follicles >14mm or E2 levels >400 pg/ml and continuing until ovulation triggering to avoid LH surge in COS
15841919|NCT04108039|Drug|Micronized progesterone|Micronized progesterone protocol to avoid LH surge in COS, from stimulation day 1 and continuing until ovulation triggering.
15841920|NCT04108026|Drug|Durvalumab|1500 mg IV every 4 weeks
15841921|NCT04108013|Drug|SHR-1210|In the experimental group, 200mg SHR-1210 was given in the first day of each cycle, Carboplatin was given in the first day of each cycle, Paclitaxel-albumin was given in the first and eighth day of each cycle, with intravenous drip.
15841922|NCT04108013|Drug|Carboplatin and Paclitaxel-albumin|In the control group, Carboplatin was given in the first day of each cycle, Paclitaxel-albumin was given in the first and eighth day of each cycle, with intravenous drip.
15841953|NCT04107779|Other|Switch from UB of Combustible Cigarette to JUUL 5% Virginia Tobacco ENDS|JUUL 5%, ENDS for 6-days in confinement
15841954|NCT04107779|Other|Switch from UB of Combustible Cigarette to JUUL 3% Virginia Tobacco ENDS|JUUL 3%, ENDS for 6-days in confinement
15841923|NCT04108000|Behavioral|SPIRIT-Dementia|"The interventionist will begin the SPIRIT-dementia session by assessing the patient's and surrogate's cognitive, emotional, and spiritual/religious representations of the patient's illness, prognosis, and end-of-life care. Individualized information will be provided about the effectiveness of life-sustaining treatment for people with end-organ failure, and the patient will examine their values about life-sustaining treatment at the end of life. The interventionist will help the surrogate prepare for end-of-life decision-making and for the emotional burden of decision-making. A Goals-of-Care document will be completed at the end of the session. The delivery of SPIRIT-dementia incorporates enhanced consent techniques, such as reducing information load by proceeding in manageable segments, offering repetition of material, opportunity for rehearsal, and using targeted questioning to verify adequate comprehension prior to eliciting preferences for goals of care."
15841924|NCT04108000|Behavioral|Usual Care|As required by Centers for Medicare and Medicaid Services (CMS) written information on advance directives is provided to a patient on the first day of dialysis, and a social worker reviews this information with patients and encourages them to complete an advance directive.
15841925|NCT04107987|Dietary Supplement|Reglicem|Reglicem is a nutraceutical containing Berberine, Curcumin, Inositol, Banaba, and Chromium Picolinate
15841926|NCT04107987|Other|Placebo|Placebo
15841927|NCT04107974|Device|Gastropexy.|Two T-fasteners for G-tube insertion (gastropexy).
15841928|NCT04107974|Procedure|Non-Gastropexy|Insertion of G-tube in absence of T-fasteners.
15841929|NCT04107961|Biological|Vaccine|Single intramuscular injection into the deltoid region
15841930|NCT04107961|Other|Placebo|Single intramuscular injection into the deltoid region
15841931|NCT04107948|Other|physical activity program|"Two weekly exercise sessions at the university hospital of St-Etienne for 1 month then relay outside in a sports association or club certified Sports Health in the Loire (42), Haute-Loire (43) or Ardèche (07) for 2 months."
15841932|NCT04107948|Other|Advice and recommendations of physical activity at home|Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy).
15841933|NCT04107935|Behavioral|TREAT-ON|"TREAT-ON is a DE-driven self-management and support program that is delivered primarily through a real-time telemedicine videoconferencing platform. Like the usual care intervention, high risk patients with DM receiving care in underserved practices will be identified by a nurse practice-based manager (PCBM) and referred to a DE for self management services. Participants will complete an initial face-to-face visit with the DE to assess needs and develop a self-management treatment plan and goals. Via telemedicine videoconferencing, follow-up visits will be delivered by the DE to participants in their homes. Follow-up visits will be used to evaluate and support progress towards meeting and sustaining self-management goals and outcomes."
15841934|NCT04107935|Behavioral|Usual Care|"A retrospective control group will be formed from individuals who have previously participated in a program called the Diabetes High Risk Initiative. In this program, patients receiving care in underserved practices are identified by a nurse PBCM to be at high risk for DM complications and/or unplanned care and referred to a DE for self management services delivered through primary care. Patients typically participate in one face-to-face visit with the DE to assess needs and develop self-management goals and then one to two follow-up encounters (generally conducted by telephone) with the PBCM or DE."
15841935|NCT04107922|Dietary Supplement|Glicoset|Patients will take a nutraceutical containing Ilex Paraguariensis, White Mulberry and Chromium Picolinate
15841936|NCT04107922|Other|Placebo|Patients will take placebo
15841937|NCT04107909|Procedure|laparoscopic cholecystectomy|"Both four port and three port LC is performed With the patient in supine position, with the surgeon and assistant on the left side and the monitor on the right side. Head up and right up position is employed during surgery in both the groups. Pneumoperitoneum of 12mmHg is created using open Hassan's method through the umbilical port.
~In 3 port a 5.5 mm umbilical visiport for 5 mm lens 30 degree A second 10 mm trocar is placed inferior to the sternum at the midline, while the third 5mm trocar is placed 4-5cm inferior to the right costal margin on the right midclavicular line. For the four port LC, additional 5mm port is placed in the sub costal region at the anterior axillary line. Posterior dissection and delineation of The Calot's triangle is done. Then, the cystic artery and cystic duct are identified, isolated, doubly clipped and divided. The gallbladder is removed through the umbilical port using a 10mm gallbladder extractor."
15841938|NCT04107896|Drug|Silodosin|Cap silodosin
15841939|NCT04107896|Drug|Tamsulosin|Cap tamsulosin
15841940|NCT04107883|Biological|fresh frozen plasma|perform plasma transfusion in different phases during perioperation
15841941|NCT04107883|Diagnostic Test|blood sample|get blood samples at several specific points in time during perioperation
15841942|NCT04107870|Behavioral|Virtual Reality Exposure Therapy sessions|Female adolescents aged 13 to 18 are proposed virtual reality exposure therapy sessions, accompanied by a cognitive and behavioral therapy (CBT) therapist, to work on their body representations
15841943|NCT04107870|Behavioral|Psychomotor therapy sessions|Psychomotor therapy sessions are proposed to female adolescents aged 13 to 18 years, ac-companied by a psychomotor therapist, to work on their body representations.
15841944|NCT04107857|Behavioral|ELEVATE enhancement to electronic health record (EHR) to improve cessation counseling offer|"Brief advise to quit smoking
~Referral to Missouri/Illinois Quitlines, Smokefree.TXT, or smokefree.gov"
15841945|NCT04107857|Behavioral|ELEVATE enhancement to electronic health record (EHR) to improve smoking cessation medication offer|-Nicotine replacement therapy, varenicline, bupropion, or combination therapy (not provided by study)
15841946|NCT04107857|Behavioral|Data Driven Feedback reports|-Feedback reports will be based on data
15841947|NCT04107844|Diagnostic Test|Novel facilitating agility dual-task test combined with already known tests|We will investigate if a combination of a novel Dual-task test combined with already known tests can identify more athletes, not ready to return to play, although symptoms of concussion have stopped.
15841948|NCT04107831|Other|Pulmonary rehabilitation|Pre-post test design
15841949|NCT04107805|Drug|BI 1323495|Tablet
15841950|NCT04107805|Drug|Placebo|Tablet
15841951|NCT04107805|Drug|Midazolam|Oral administration
15841952|NCT04107792|Behavioral|parental sense of competence workshop|The intervention will be a two-hour parent education workshop that provides education and teaches parent-mediated strategies for managing children's behaviours associated with SPIs.
15841964|NCT04107766|Device|Microwave Ablation|Patients who meet the eligibility criteria will undergo microwave ablation (MWA) with the NEUWAVE Microwave Ablation System with or without Ablation Confirmation of at least one soft-tissue liver lesion, in accordance with the study site's standard-of-care (SOC) practices.
15841965|NCT04107753|Behavioral|Brief counseling based on the 5As model|"It is a structured brief counselling perfomed by nurse who takes clinical care of the patient and it is performed as follow:
~ASK: every patient should be asked whether he/she is or is not a smoker;
~ADVICE: the patient is advised to quit in a strong, clear and personalized way;
~ASSESS: the patient is asked if he/she would like to quit and the strenght of his/her dependence is assessed.
~ASSIST: The smoker interested in quitting are assisted in their attempts, for example by helping them to define a quit date, by advising them about strategies against withdrawal symptoms and by providing them information material; patients are asked whether they want to be contacted by the CTT.
~ARRANGE: this step is only addressed to the patients who have started a treatment in the CTT and is expected to prevent or treat eventual relapses."
15841966|NCT04107740|Drug|C-Trelin OD Tab(5mg Taltirelin Hydrate)|BID, 10mg per day, for 24 weeks
15841967|NCT04107740|Drug|Placebo|BID for 24 weeks
15841968|NCT04107727|Drug|Quizartinib|"Induction: oral quizartinib (dose defined in safety run-in phase) 14 days (8-21) (dose will be halved with strong CYP3A inhibitor), up to 2 cycles of 35 days.
~Consolidation: oral quizartinib (dose defined in safety run-in phase) 14 days (6-19) (dose will be halved with strong CYP3A inhibitor), up to 4 cycles of 35 days.
~Maintenance: oral quizartinib 60mg/day (dose will be halved with strong CYP3A inhibitor), up to 12 cycles of 28 days."
15841969|NCT04107727|Drug|Placebo oral tablet|"Induction: oral placebo (dose defined in safety run-in phase) 14 days (8-21) (dose will be halved with strong CYP3A inhibitor), up to 2 cycles of 35 days.
~Consolidation: oral placebo (dose defined in safety run-in phase) 14 days (6-19) (dose will be halved with strong CYP3A inhibitor), up to 4 cycles of 35 days.
~Maintenance: oral placebo 60mg/day (dose will be halved with strong CYP3A inhibitor), up to 12 cycles of 28 days."
15841970|NCT04107727|Drug|Cytarabine|"Induction: Cytarabine continuous IV infusion, 200 mg/m2 (days 1-7), up to 2 cycles of 35 days.
~Consolidation: Cytarabine IV infusion, 1,5-3 g/m2 (days 1, 3, 5), up to 4 cycles of 35 days."
15841971|NCT04107727|Drug|Idarubicin|Induction: Idarubicin IV infusion 12 mg/m2 (days 1-3), up to 2 cycles of 35 days.
15841972|NCT04107714|Behavioral|STC|"The peer-led and web-based group program contains four lessons plus one booster session:
~Lesson 1: Consider the pros and cons of disclosing: Participants reflect on their experience of self-stigma and weight their pros and cons of (non-)disclosing their child's mental illness.
~Lesson 2: Different ways to disclose: Participants learn about different ways to disclose and their respective pros and cons. Afterwards participants discuss possible responses they might experience and develop strategies to cope with.
~Lesson 3: Communication about disclosure between parents and their child: Participants discuss pros and cons of (non-)disclosure for their children and how to negotiate whether to disclose or not.
~Lesson 4: Telling your story: Participants learn how to tell their own story.
~In a booster session, participants discuss their experiences with disclosure or non-disclosure."
15841973|NCT04107688|Other|Control|Subjects will use plain water as an oral rinse twice a day for 3 days.
15841974|NCT04107688|Other|CPE|Subjects will use a cranberry-derived oral rinse twice a day for 11 days.
15841975|NCT04107675|Drug|Liposomal Cyclosporine A|Liposomal Cyclosporine A is administered with the PARI L-CsA eFlow Nebulizer.
15841976|NCT04107675|Drug|Liposomal Placebo|Liposomal Placebo is administered with the PARI L-CsA eFlow Nebulizer.
15841977|NCT04107662|Device|Tbit system|Suspected traumatic brain injury with head CT
15841978|NCT04107649|Behavioral|Telephonic Active Coaching (Motivational Interviewing) + Financial Incentives|As part of TAC(MI)+FI, participants speak with a health coach at Brigham and Women's Hospital once a week via telephone for weeks 5-13 following surgery, and once every other week for weeks 14-31 after surgery. Participants in this arm can receive financial rewards for achieving weekly physical activity goals, as well as bonus rewards for achieving goals multiple weeks in a row. Over the course of this 6-month long TAC(MI)+FI intervention period, these participants are able to receive up to $680 for meeting physical activity goals, and up to $180 in bonus rewards.
15841979|NCT04107649|Behavioral|Wrist based activity tracker wear|Participants who receive this intervention are eligible to receive $5/week for wearing a wrist-based activity tracker daily for 48-weeks ($240 total), beginning 6-weeks after surgery. Activity tracking data will be collected on a weekly basis.
15841980|NCT04107649|Behavioral|Phone calls to provide information about general well being|From weeks 5-13 after surgery, participants receive weekly calls to provide educational information about improving general well-being. These calls occur once every other week for weeks 14-31 following surgery.
15841981|NCT04107649|Other|Basic Study Activities|Basic study activities begin two-weeks before TKR and end approximately 24-months after TKR. Basic study activities include: two in-person visits at the local clinic site (2 weeks before TKR and 32-weeks after TKR), completing 6 surveys, and wearing an ActiGraph activity tracker (waist-worn) for five one-week periods throughout the study (2-weeks before-TKR, 32-weeks post-TKR, one-year post-TKR, 18-months post-TKR, two-years post-TKR). All participants will wear a wrist-worn activity tracker simultaneously with the ActiGraph 2-weeks before-TKR. All participants will be eligible to receive up to $235 for completing these activities over the course of two years.
15841982|NCT04107636|Procedure|Vacuum assisted biopsy|First, the tumor will be removed under local anesthesia using the VAB system with US guidance, through a small skin incision (<0.5 cm). A localization marker will be placed in the biopsy cavity, to help determine the cavity location.
15841983|NCT04107636|Procedure|conventional lumpectomy|After 3 weeks, the breast conserving surgery is performed, excising the VAB excision cavity and a ≥1 cm of surrounding tissue, as deemed appropriate by the attending breast surgeon. A sentinel node biopsy will be performed in the same procedure.
15841985|NCT04107610|Device|I-PAS|I-PAS is a portable, head-mounted display goggle system with integrated eye tracking technology. I-PAS records eye movements in response to visual and auditory stimuli.
15841986|NCT04107597|Other|Core stabilization exercises|Twelve specific exercises following a standard protocol aiming at an intersegmental stabilization of the spine and strengthening and stabilization of specific muscle groups. The exercises are performed under instruction and supervision by a physiotherapist twice per week for 45 minutes
15841987|NCT04107597|Other|Core stabilization exercises and paced breathing training|Twelve specific exercises following a standard protocol aiming at an intersegmental stabilization of the spine and strengthening and stabilization of specific muscle groups. The exercises are performed under instruction and supervision by a physiotherapist twice per week for 45 minutes. In addition, the participants practice paced breathing training (before and during the CSE sessions as well as 15 minutes twice per day at home) which has a modulating effect on the autonomic nervous system
15841988|NCT04107597|Other|Myofascial trigger point release|A standard protocol of 12 myofascial and trigger point release grips followed by so-called roll-down maneuvers and manual rhythmical oscillation, applied to specific muscles and muscle groups. The treatment is applied twice per week for 45 minutes
15841989|NCT04107597|Other|Myofascial trigger point release and paced breathing training|A standard protocol of 12 myofascial and trigger point release grips followed by so-called roll-down maneuvers and manual rhythmical oscillation, applied to specific muscles and muscle groups. The treatment is applied twice per week for 45 minutes. In addition, the participants practice paced breathing training (before and during the MTPR sessions as well as 15 minutes twice per day at home) which has a modulating effect on the autonomic nervous system
15841990|NCT04107571|Procedure|A type of operation for coranary heart disease patients.|A type of operation for coranary heart disease patients.
15841991|NCT04107558|Device|Virtual Reality|Subjects will undergo painful stimuli without HVR followed by a session with HVR. Subjects are their own control
15841992|NCT04107545|Behavioral|athletes|Control of body temperature using the bodyCap temperature monitor that records body temperature for up to 48h (three times)
15841993|NCT04107532|Other|Virtual Reality Therapy and Imagination Exposure Therapy|Virtual Reality Therapy and Imagination Exposure Therapy
15841994|NCT04107519|Behavioral|Goal-Directed Resilience Training|This pilot study seeks to test the efficacy of a resilience skills training intervention for former football players who experience chronic pain. Between 20 to 48 eligible and consented participants from the Atlanta area will be identified (with a goal of 40 completing the study). They will undergo a pre-training test session and will then be randomized to either the Immediate GRIT (ImT) training intervention or the Delayed Training (DeT) control. The immediate (ImT) group will be trained for 4 weeks with 2 biweekly sessions. At the end of GRIT training they will be post-tested. The delayed (DeT) group wait during these 4 weeks and do not receive training. At the end of the 4-week waiting period, they will also be post-tested. At this point, they will be offered GRIT training for 4 weeks with 2 biweekly sessions. At the end of their training, they will be given a second post-testing. This process will then be repeated for two additional groups of 5-12 lmT and 5-12 DeT participants.
15841995|NCT04107506|Behavioral|Filming Interactions to Nurture Development|FIND is a brief home-based video coaching intervention which involves feedback provided by the coach to the caregiver using brief film clips derived from video of caregiver-child interaction collected in the home. The coaching focuses on showing caregivers instances in which they are engaging in developmentally-supportive interactions during coaching sessions. FIND is delivered over 10 weekly home visits lasting 30-45 minutes. The process begins with an initial visit in which the coach provides an overview, records 10-15 minutes of caregiver-child interaction, then introduces the concept of serve and return. The video is edited to show brief clips in which the caregiver is engaged in the first of five specific caregiver-based components of serve and return. The next week, the FIND coach reviews the edited clips in detail with the caregiver. Sessions continue, alternating between filming and coaching sessions until all five components have been covered sequentially.
15841996|NCT04107506|Behavioral|The Healthy Toddler Program|HTP, the active control intervention, consists of weekly home visits alternating between (a) coaching sessions covering one of five domains of child development (Motor, Cognitive, Language, Play, and Social-Emotional and (b) observation sessions that will include a review of the prior coaching session and an observation and discussion of the caregiver-child interaction. This intervention will consist of 10 home visits each lasting 25-30 minutes. The coach will not engage in any filming or video coaching, but will be able to discuss caregiving concerns. HTP materials are adapted from the Partners for a Healthy Baby curriculum developed by Florida State University's Center for Prevention and Early Intervention Policy.
15841997|NCT04107493|Device|Portable Oxygen Cylinder|A POC is a medical device that is indicated for patients who require supplemental oxygen, including COPD patients
15841998|NCT04107493|Device|Mobi|ResMed's variant of POC
15841999|NCT04107480|Procedure|Endoscopic trans-sphenoidal adenoma resection|"Neurosurgical consultation consists of at least one consult with a neurosurgeon and at least one consult with an endocrinologist with relevant experience. If the multidisciplinary team (MDT) agrees the patient is a good surgical candidate, the patient is asked consent for surgery, as is a custom part of preoperative requirements. When the patient decides not to have the surgery, (s)he will receive standard medical treatment, but will continue study follow up in the intervention group.
~Surgery only takes place if both the MDT and the patient agree to it and should then be planned within three months after randomization. Surgery is performed by one or two trained neurosurgeons in the hospital where the counseling took place. A standard, semi-protocolled, endoscopic trans-sphenoidal surgical resection of the prolactinoma is performed according to standard practice."
15842000|NCT04107480|Drug|Dopamine Agonists|"The treating physician adheres to the treatment protocol in general, but has freedom to choose treatment to his/her ideas how to deliver best care.
~Current first line treatment consists of a dopamine agonists: cabergoline (currently the most used), bromocriptine or quinagolide. All dopamine agonists are taken orally, and the dosage may be raised based on its effect. It is usually titrated to achieve a normal or suppressed prolactin level and restoration of the gonadal axis. Dopamine agonist treatment is discontinued after 2 years of treatment, unless a normal prolactin level cannot be achieved. The dopamine agonist is restarted when prolactin levels rise after the medication is discontinued.
~In standard care, surgical treatment is reserved for patients who don't tolerate medication, or whose adenoma fails to show a sufficient response. Patients in the control group with an intolerance for dopamine agonists or an insufficient response may be offered surgery as part of standard care."
15842001|NCT04107454|Device|Active microablative fractional CO2 laser designed as SmartXide Touch C60, CO2 laser system for MonaLisa Touch, DEKA, Florence|Active application of laser radiation on the vulvar skin. The laser setting is: Power 24 W, exposure time 400 microsec, density 6,4 %, pulse energy 23,2 mJ, fluenz 1,18J/cm2, emission mode DP, DOZ Dwell 400, DOT spacing 1000.
15842099|NCT04106726|Drug|Ivermectin cream 1%|Apply topically to the face once daily for 84 consecutive days.
15842002|NCT04107454|Device|Sham microablative fractional CO2 laser designed as SmartXide Touch C60, CO2 laser system for MonaLisa Touch, DEKA, Florence|Sham application of laser radiation on the vulvar skin. Laser setting is a sham dose:power 0, 5 W, exposure time 400 microsec, DOT spacing 1000
15842003|NCT04107441|Drug|AX-8 Part 1|5, 10, 20, and 40 mg AX-8 orally disintegrating tablets (ODTs), up to 80 mg/day split over 2 time points, 8 hours apart (i.e. Dose 1: 0 hour and Dose 2: + 8 hours). AX-8 ODTs will be administered orally and will be dissolved on the back of the tongue while the subject is in a sitting position. The subjects will be instructed not to suck, chew or swallow the tablet, i.e. to allow it to dissolve on the back of the tongue without any further intervention.
15842004|NCT04107441|Drug|AX-8 Part 2|5 and 40 mg AX-8 orally disintegrating tablets (ODTs), 45 mg/day split over 2 time points, 8 hours apart (i.e. Dose 1: 0 hour and Dose 2: + 8 hours). AX-8 ODTs will be administered orally and will be dissolved in the mouth while the subject is in a sitting position. The subjects will be instructed to actively move the tablet around in their mouth (i.e. active oral manipulation of the tablet) until it is fully dissolved.
15842005|NCT04107428|Drug|Somatostatin|A bolus of 5cc of saline containing 500 mcg of somatostatin will be administered intravenously after graft reperfusion (after portal and arterial anastomosis) over a 2 minutes period, followed by a continuous infusion of 250 mcg per hour of somatostatin (infusion rate 2.5 cc/hour) for 10 days.
15842006|NCT04107428|Drug|Placebo|A bolus of 5cc of saline will be administered intravenously after graft reperfusion (after portal and arterial anastomosis) over a 2 minutes period, followed by a continuous infusion of 2.5 cc of saline/hour for 10 days.
15842007|NCT04107415|Other|yoga|A total of 12 yoga sessions, 2 sessions a week for 6 weeks, was applied to the patients in the experimental group.
15842008|NCT04107402|Other|Assessment of coagulopathy, Platelets activation and Platelets-Neutrophils interplay|Blood sample Urine Sample Pulmonary, hepatic and cardiac tissue from biopsy and autopsy
15842009|NCT04107389|Behavioral|Art Psychotherapy, Art Therapy|Art Therapy is a form of psychotherapy, based upon the premise of utilising art materials as a form of expression and communication; the roots of the theoretical approach lie in a psychodynamic approach to working with the unconscious.
15842010|NCT04107389|Behavioral|Wait List|Wait list control group. Participants randomised to Wait List group or Intervention group.
15842011|NCT04107376|Diagnostic Test|Retroviewing endoscopy|The colon is inspected with a new retroviewing endoscope
15842012|NCT04107363|Procedure|Oropharyngeal aspiration before changing the position of the patient|"Patients in the experimental group underwent oropharyngeal aspiration prior to each position change in addition to routine nursing care (Endotracheal aspiration in case of indication and oropharyngeal aspiration in the follow-up; routine and non-routine position changes every 2 hours during the day and 4 hours during the night; oral care).
~Patients in this group underwent oropharyngeal aspiration at least 9 times in 24 hours with a pressure of 100-120 mmHg for 10 seconds prior to routine (2 hours a day, 4 hours a night) and non-routine position changes. After the oropharyngeal aspiration was completed, the patient's position was changed."
15842013|NCT04107363|Other|Control group:|The patients in the control group received routine nursing care in the unit. (Endotracheal aspiration in case of indication and oropharyngeal aspiration in the follow-up; routine and non-routine position changes every 2 hours during the day and 4 hours during the night; oral care).
15842014|NCT04107350|Device|whole-body vibration|10 minutes WBV exercise in standing position; amplitude 2mm,; frequency 4-10Hz; resting interval: 3 minutes rest.
15842015|NCT04107337|Other|Vocal work session with straw exercises|"Voice assessment: A questionnaire on the subject's voice biography will be sent to the subject at the moment of inclusion.
~Vocal exercises during 10 minutes : (1 minute) Checking the posture ; (1 minute) Control of the management of breath in the straw ; (1 minute) Phonation in the straw ; (2 minutes) Make a siren in the straw ; (4 minutes) Vocalizations in the straw on the arpeggio of Rossini.
~This working session will be preceded and followed by the same 10-minutes voice assessment focusing on aerodynamic parameters."
15842016|NCT04107337|Other|Vocal work session with open mouth exercises|"Voice assessment: A questionnaire on the subject's voice biography will be sent to the subject at the moment of inclusion.
~Vocal exercises during 10 minutes : (1 minute) Checking the posture ; (1 minute) Control of the management of breath on a [f] with open mouth ; (1 minute) Phonation on the vowel [a] with open mouth ; (2 minutes) Make a siren on the vowel [a] with open mouth ; (4 minutes) Vocalizations on the vowel [a] on the arpeggio of Rossini with open mouth.
~This working session will be preceded and followed by the same 10-minutes voice assessment focusing on aerodynamic parameters."
15842017|NCT04107324|Procedure|ARAPS|In a previous experimental study on rats, the investigators have shown that PVE combined with radiofrequency ablation (RFA), hereafter called Associated Radiofrequency Ablation and Portal Vein Ligation for Staged Hepatectomy (ARAPS), can induce accelerated growth of the FLR
15842018|NCT04107324|Procedure|PVE|Portal vein embolisation
15842019|NCT04107298|Device|SUNDANCE™ Drug Coated Balloon|Angioplasty procedure with a sirolimus-coated, percutaneous transluminal angioplasty (PTA) balloon catheter
15842020|NCT04107285|Behavioral|neurocognitive evaluations|The test battery consists of validated and reliable measures of attention, executive functions and memory.
15842021|NCT04107285|Diagnostic Test|brain MRIs|Patients will undergo baseline and follow-up research MRIs in the same scanner at MSKCC (3 Tesla scanner (GE, Discovery 750W, USA) with a GEM HNU 24-channel head coil) (total scan duration=15 minutes).
15842022|NCT04107285|Other|Blood samples|Blood samples will be collected at each time point (Day -1, day 0, day 1, day 3, day 5, day 7, day 10, day of neurotoxicity onset, and 3-4 months post- CART).
15842023|NCT04107272|Device|Real repetitive transcranial magnetic stimulation|"The real rTMS will be delivered over M1 (hand representation) of dual hemispheres with 10 trains of 10 Hz pulses for 10 seconds, with a total of 1,000 pulses per hemisphere. The real rTMS intensity will be set as 80% resting motor threshold and the interval between each train of pulses will be set as 50 seconds. The real rTMS will be delivered as daily session for five consecutive days, followed by two fortnightly maintenance sessions during the follow-up period after the completion of five daily sessions. The real rTMS will be delivered by designated physical therapists using figure-of-8 shaped coil."
15842024|NCT04107272|Device|Sham repetitive transcranial magnetic stimulation|The sham rTMS of this study will be delivered with the same active coil angled 90-degree way from the scalp. The intensity of sham rTMS will be set at lowest stimulator output that can generate similar noise to the real rTMS. The sham rTMS will be delivered in the same manner and duration with real rTMS.
15842025|NCT04107259|Diagnostic Test|Blood sample|Ten ml of venous blood was collected from all participants in the early morning after an overnight 12 hour fast by venipuncture of the antecubital vein into sterile tubes. Plasma and sera were separated immediately and were stored at -70 C until biochemical analyses.
15842026|NCT04107246|Device|use of the KaliJAR box|"KaliJAR® : validated device for single-dose eye drops collection. the patient will be asked to discard each single dose of eye drops in the KaliJAR box. The patient returns with the KaliJAR box at each consultation as part of normal practice. The KaliJAR box will be emptied at each consultation by the doctor and then returned to the patient.
~No further examination or visit."
15842027|NCT04107233|Behavioral|Audit and Feedback|Charts for enrolled physicians will be audited and they will receive feedback, consisting of tailored reports and one-on-one meeting with colleague to review at baseline, 3 months and 6 months
15842028|NCT04107220|Drug|Sacubitril/Valsartan|Effect of Sacubitril/Valsartan on BNP and NT-proBNP
15842029|NCT04107207|Dietary Supplement|Ginger Kombucha|Craft Ginger Kombucha, a fermented black tea
15842030|NCT04107207|Dietary Supplement|Ginger Water|Placebo
15842031|NCT04107194|Drug|Pantoprazole 40mg|Proton pump inhibitor
15842032|NCT04107194|Drug|Amoxicillin 1000 MG|Antibiotic
15842033|NCT04107194|Drug|Clarithromycin 500mg|Antibiotic
15842034|NCT04107194|Drug|Metronidazole|Antibiotic
15842035|NCT04107194|Drug|Tetracycline 125 MG|Antibiotic
15842036|NCT04107194|Drug|Bismuth Subcitrate|Antibiotic adjuvant
15842037|NCT04107194|Drug|Rifabutin 150 MG|Antibiotic
15842038|NCT04107194|Drug|Levofloxacin 500mg|Antibiotic
15842039|NCT04107181|Device|"Introducer calla device"|The research introducer will be used after the patient consents prior to the annual pap smear.
15842040|NCT04107181|Behavioral|Interviews only|Healthy volunteer interviews
15842041|NCT04107168|Drug|Nivolumab|A human immunoglobulin G4 (IgG4) monoclonal antibody, which binds to the programmed death-1 receptor (PD-1).
15842042|NCT04107168|Drug|Pembrolizumab|A human immunoglobulin G4-kappa (IgG4-kappa) monoclonal antibody that targets PD-1.
15842043|NCT04107168|Drug|Ipilimumab|A human immunoglobulin G1 (IgG1) monoclonal antibody raised against cytotoxic T lymphocyte antigen-4 (CTLA-4).
15842044|NCT04107168|Drug|Durvalumab|A human immunoglobulin G1-kappa (IgG1-kappa) monoclonal antibody that binds to programmed death ligand 1 (PD-L1).
15842045|NCT04107168|Drug|Tremelimumab|A fully human monoclonal antibody raised to target cytotoxic T lymphocyte-associated antigen 4 (CTLA-4).
15842046|NCT04107168|Drug|Atezolizumab|A humanised IgG1 monoclonal antibody raised to target programmed death-ligand 1 (PD-L1).
15842047|NCT04107168|Drug|Bevacizumab|A humanised IgG1 monoclonal antibody raised to target vascular endothelial growth factor (VEGF).
15842048|NCT04107155|Dietary Supplement|Weight Management Formulation|Saffron extract and Gynostemma extract with hesperidin
15842049|NCT04107155|Dietary Supplement|Placebo|Placebo
15842050|NCT04107155|Other|Handout with Suggestions for Healthy Eating and Overall Health|Suggestions for Healthy Eating and Overall Health
15842051|NCT04107155|Other|Handout with Suggestions for Healthy Eating and Overall Health|Suggestions for Healthy Eating and Overall Health
15842052|NCT04107142|Biological|Adoptive Cell Transfer of NKG2DL-targetting Chimeric Antigen Receptor-grafted Gamma Delta T cell|Adoptive Cell Transfer of Haploidentical / Allogeneic NKG2DL-targeting Chimeric Antigen Receptor-grafted γδ T Cells (CTM-N2D)
15842053|NCT04107129|Procedure|Endometrial Biopsy|An endometrial biopsy is the removal of a small piece of tissue from the endometrium, which is the lining of the uterus. Endometrial tissue will be tested for BCL6 and SIRT1 Biomarkers
15842054|NCT04107129|Other|Euploid embryo transfer|Patients undergoing IVF and Preimplantation genetic testing will undergo delayed euploid frozen embryo transfer per clinical protocol and standard of care.
15842055|NCT04107129|Diagnostic Test|Blood sample|Estradiol and Progesterone levels in the blood will be checked
15842056|NCT04107116|Behavioral|Program participants|The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk.
15842057|NCT04107116|Other|Usual Care|Usual care as provided by local oncologists
15842058|NCT04107103|Drug|Combination Product: Nivolumab with Pemetrexed|Nivolumab 3 mg/kg IV q.2 weekly in combination with pemetrexed 500mg/m2 q.6weekly. Treatment with nivolumab will continue every 14-days, and pemetrexed treatment will continue every 42-days. Treatment continues until disease progression or toxicity resulting in treatment discontinuation or until 2 years of treatment.
15842059|NCT04107090|Other|lung recruitment maneuver|Lung recruitment maneuver done for ventilated preterm neonates diagnosed with respiratory distress syndrome
15842060|NCT04107090|Other|tracheal IL-6 level|tracheal IL-6 level was measured before and after recruitment maneuver
15842061|NCT04107090|Other|US guided lung recruitment maneuver|Lung recruitment maneuver done for ventilated preterm neonates diagnosed with respiratory distress syndrome guided by lung ultrasound
15842062|NCT04107077|Drug|Cisplatin|Laparoscopic HIPEC will be performed at a maximum of two (2) times spaced approximately 6 weeks apart. The dosing of the drugs will be the same during each administration but adjusted if needed based on lab work. The typical dosages are 200mg of Cisplatin
15842063|NCT04107077|Drug|Mitomycin|Laparoscopic HIPEC will be performed at a maximum of two (2) times spaced approximately 6 weeks apart. The dosing of the drugs will be the same during each administration but adjusted if needed based on lab work. The typical dosages are 30mg of Mitomycin C.
15842064|NCT04107064|Behavioral|NaW|Participants will receive assistance with finding employment, onboarding, training, and so on.
15842065|NCT04107064|Behavioral|NaW-DS|Participants will receive assistance with onboarding and training 6 months after the initiation of their employment.
15842067|NCT04107038|Procedure|General Endotracheal Anesthesia|Participants receive general endotracheal anesthesia for the procedure, as well as analyzing the information from their transesophageal echocardiography per routine clinical care.
15842068|NCT04107038|Procedure|Monitored anesthesia care|Participants receive monitored anesthesia care for their procedure.
15842069|NCT04107025|Other|HELP|Individual counseling were given to each intervention group participant. They were assisted with safety, emotional and mental support and referrals for health and financial assistance. Participants were also given handout to manage anxiety and panic situations during the legal procedures.
15842070|NCT04107012|Device|Orthodontic treatment with clear aligner|Included orthodontic treatment with clear aligner (eon Aligners)
15842071|NCT04106999|Drug|Dexmedetomidine|Drug infusion will be delivered intra-operatively
15842072|NCT04106999|Drug|Placebos|Normal Saline will be infused as a control drug
15842073|NCT04106986|Combination Product|Pulsed electromagnetic field and Progressives resistance exercise|"The pulsed electromagnetic field treatment consist of 30 minutes pulsed electromagnetic field with 50 Hz pulses
~The progressive resistance exercise training consist of 45 minutes of progressive resistance exercise protocol as the following:
~The PRE session begun with warm-up exercises that included riding a stationary ergometer for 5 minutes followed by stretching exercises for the hamstrings, quadriceps and gastrocnemius muscles. After this, subjects performed non-weight bearing (open chain) and weight bearing (closed chain) quadriceps exercises.
~The amount of resistance and number of repetitions for each exercise are based on a modification of the daily adjustable progressive resistance exercise (DAPRE) program that was described by Knight eta al."
15842074|NCT04106986|Other|PRE|"The progressive resistance exercise training consist of 45 minutes of progressive resistance exercise protocol as the following:
~The PRE session begun with warm-up exercises that included riding a stationary ergometer for 5 minutes followed by stretching exercises for the hamstrings, quadriceps and gastrocnemius muscles. After this, subjects performed non-weight bearing (open chain) and weight bearing (closed chain) quadriceps exercises.
~The amount of resistance and number of repetitions for each exercise are based on a modification of the daily adjustable progressive resistance exercise (DAPRE) program that was described by Knight eta al."
15842075|NCT04106960|Other|No Intevention Used|N/A as in the study does not have intervention in place. It is exploring the relationships between the social and physical features of the environment and participation through using standardized outcome measures.
15842076|NCT04106947|Other|Questionnaires|Questionnaires
15842077|NCT04106921|Other|Universal Health Coverage Mode|"In the intervention arm, the CHW's household list will appear differently within the app in the following ways:
~The CHW will be able to filter and order households by the date of the most recent home visit.
~A color-coded visual icon will display the number of home visits in the past month for each household.
~A red exclamation mark will be displayed for every household that has not reached 2 visits in the past month (default at the start of every month).
~Text displayed below each household showing the date of last visit will turn red if more than 30 days have passed since last visit. When more than 60 days have passed since the most recent visit, the text displayed below each household showing the date of last visit will be changed to date of last visit is unknown in red.
~The family profile will also contain the date of last visit, and the visits they have received in that month"
15842078|NCT04106908|Biological|Eqwilate|Eqwilate® is a new generation, albumin-free, high-purity, double virus-inactivated, freezedried concentrate of VWF and FVIII
15842079|NCT04106895|Drug|Fibryga|Fibryga
15842080|NCT04106882|Drug|Ketones|Supplement administered mid-scan.
15842081|NCT04106882|Drug|Glucose|Supplement administered mid-scan.
15842082|NCT04106869|Other|Hyperventilation|"Ventilatory settings will be the following:
~6-8 ml/kg and Respiratory rate adjusted to the required ETC02 (<35 mmHg) PEEP in order to ensure a driving pressure (P plateau- PEEP) below 15 mmHg."
15842083|NCT04106869|Other|Hypoventilation|"Ventilatory settings will be the following:
~6-8 ml/kg and Respiratory rate adjusted to the required ETC02 (40-45 mmHg) PEEP in order to ensure a driving pressure (P plateau- PEEP) below 15 mmHg."
15842084|NCT04106856|Radiation|Hypofractionated Radiation Therapy|Undergo hypofractionated radiation therapy
15842085|NCT04106856|Drug|Losartan|Given PO
15842086|NCT04106856|Drug|Losartan Potassium|Given PO
15842087|NCT04106856|Other|Quality-of-Life Assessment|Ancillary studies
15842088|NCT04106856|Other|Questionnaire Administration|Ancillary studies
15842089|NCT04106843|Drug|Lutetium Lu 177 Dotatate|Given IV
15842090|NCT04106830|Drug|Intravenous steroid|This study does not limit treatment methods.patients commonly use high-dose intravenous steroid therapy (HD-S) during acute stage. The HD-S treatment course referred to intravenous administration of 1 g of glucocorticoid daily for 3 consecutive days and continuous dose 240 mg reduction for 60mg oral administration. Immunomodulatory therapies are necessary for the remission stage. The treatment methods include: Azathioprine (start at 50 mg per day, add 50 mg per week to 2 mg/kg.d); Mycophenolate Mofetil (The initial dose was 0.25g bid, add 0.5g per week to 0.75g bid); and Rituximab (500 mg on the 1st day, the 15th day, then 500mg per half year).
15842091|NCT04106817|Biological|Live, wild-type A/California/H1N1 2009 influenza virus|Live, wild type influenza A virus that was inoculated and manufactured in allantoic fluid of SPF embryonated hen eggs
15842092|NCT04106804|Drug|Abatacept 125 MG/ML|Patients will receive weekly abatacept (Orencia®) s.c. Abatacept in the dose regimen given in the label for RA and PsA for six months
15842093|NCT04106791|Device|closed-loop system for vasopressor administration|The closed-loop system' goal is to keep MAP within 5 mmHg of the predefined target MAP.
15842094|NCT04106778|Drug|DMT310|Topical Powder
15842095|NCT04106778|Drug|Placebo|Placebo Topical Powder
15842096|NCT04106752|Dietary Supplement|Caffeine|Provide caffeine supplements with or without meal before exercise
15842097|NCT04106739|Device|Drug Relief V(version) 2.0 Auricular Percutaneous Electrical Neural Field Stimulation (PENFS)|"This is a Small electronic circuit board with a minimal number of electronic components in it, which is powered by three zinc-air batteries. Each battery consists of 1.4v of charge. From this charge, the circuit produces a maximum voltage of 3.4V under no load condition.
~The produced Voltage is driven as output by using the three stimulation wires, and the fourth insulated wire acts as a ground. The wires are Bio-compatible and do not have any impact when in contact with the human skin. The wire is attached with a needle to transfer the produced voltage into the nerves of the human ear. The sterilized needle (Titanium) is attached at the end of the wire through a snap fit ring. All the materials used are gone through necessary safety and performance testing including bio-compatibility and sterility testing, wherever necessary."
15842098|NCT04106726|Drug|Soolantra® Ivermectin cream 1%|Apply topically to the face once daily for 84 consecutive days.
15842100|NCT04106726|Drug|Placebo for Ivermectin cream 1%|Apply topically to the face once daily for 84 consecutive days.
15842101|NCT04106713|Behavioral|Individual Psychotherapy|The individual therapy program will differ in orientation according to therapist and session notes will be coded according to the Comparative Psychotherapy Process Scale. Therapy sessions take place approximately once every fortnight, with 8 sessions in total, according to the agreed-upon schedule.
15842102|NCT04106713|Behavioral|Internet-delivered Cognitive Behavioural Therapy (iCBT)|"The iCBT program (clinician follow-up with the therapist and 4 online modules) will be administered for 8 weeks. The four modules: 1) psychoeducation about emotions, including a functional nature of emotions; 2) alteration of antecedent cognitive misappraisals; 3) prevention of emotional avoidance; and 4) modification of emotion-driven [behaviours] (EDBs), are adapted from The Unified Protocol (UP) for transdiagnostic treatment of emotional disorders. UP is a CBT consisting of four overarching themes- increasing emotional awareness, facilitating flexibility in appraisals, identifying and preventing [behavioural] and emotional awareness, and situational and interoceptive exposure to emotion cues."
15842103|NCT04106713|Behavioral|Group Cognitive Behavioural Therapy (group CBT)|The group CBT program (for e.g. PsychUp) will be conducted over 8 weeks, with weekly 2-hour sessions. Each group consists of 4-8 patients and are facilitated by two practicing clinical psychologists and one clinical psychologist in training. Sessions are structured such that each session, except the first, begins with a brief review of previous session material and a collaborative review of homework. This is followed by introduction of new material and completion of any in-session exercises, with sessions concluding with homework assignment. Specific treatment content is similarly adapted from UP. Session 1 begins by covering psychoeducation on the CBT model of pathological depression and anxiety and the role of avoidance in maintenance of symptoms. Sessions 2 to 7 covers goal-setting, cognitive reappraisal and development of adaptive emotional coping strategies through situational emotion-focused exposures. Session 8 ends with a discussion on relapse prevention.
15842104|NCT04106700|Drug|Apixaban 2.5 MG|Apixaban will be started simultaneously with anti myeloma treatment on day 1 of cycle 1 of VTD, and continues for 4 to 6 months depending on the number of induction cycles administered to the patient
15842105|NCT04106687|Procedure|Ultrasound Guided Caudal Block|Postoperative pain procedure
15842106|NCT04106687|Procedure|Sacral Erector Spinae Block|Postoperative pain procedure
15842107|NCT04106674|Procedure|Open reduction internal stabilisation (ORIF)|Treatment allocated to surgical or non-surgical group. Implant choice pragmatic, surgeons choice.
15842108|NCT04106661|Other|Tai Chi|Physical activity requiring slow, controlled whole body movement and weight shifting.
15842109|NCT04106635|Procedure|Paratracheal pressure|To apply paratracheal pressure, the thumb was placed over the left side of the trachea cephalad to the clavicle and medial to the sternocleidomastoid muscle.
15842110|NCT04106635|Procedure|Cricoid pressure|To apply cricoid pressure, the cricoid cartilage is compressed by 30N force with a single-handed three finger maneuvre towards the vertebral bodies.
15842111|NCT04106622|Procedure|electrophysiological study|"To assess whether the AP is of high risk or not, for all patients the AERP of the AP will be determined by one of the following ways:
~The cycle length at which abrupt and complete loss of pre-excitation occurs during exercise test. If this didn't happen, the patient will be subjected to invasive electrophysiologic study..
~The Antegrade refractory period of the AP is measured during EPS as the shortest cycle length with one-to-one conduction over the AP by incremental atrial stimulation after which the QRS becomes narrow or no conduction occurs due to block of the impulse in the AP.
~The shortest pre-excited R-R interval during spontaneous or induced AF."
15842112|NCT04106609|Other|Supervised, individualized exercise oncology program|The study intervention is a supervised, individualized exercise oncology program described in previous literature2,3,12 and provided by Maple Tree Cancer Alliance, a non-profit organization providing exercise training to individuals with cancer (https://www.mapletreecanceralliance.org/). This organization was founded in 2011 and currently operates in 9 hospitals serving Ohio and Pennsylvania, offering free exercise programs and nutritional guidance to approximately 500 patients annually to help relieve side effects related to cancer treatment.
15842113|NCT04106609|Other|Current standard of care|Resource guide with various options available to cancer survivor. Within this guide are tips for healthy eating and pictures of standard exercises to improve fitness.
15842115|NCT04106570|Other|fatiguability of the knee extensors|fatiguability of the knee extensors (in N.m) measured with a dynamometer.
15842116|NCT04106557|Drug|Gaboxadol|OV101 versus placebo once daily at bedtime for 12 weeks
15842117|NCT04106557|Drug|Placebo|Matching placebo capsules to OV101 capsules.
15842119|NCT04106505|Behavioral|Biofeedback training via app on smartphone|Biofeedback training as described in biofeedback arm.
15842120|NCT04106505|Behavioral|Sham-biofeedback training via app on smartphone|Sham-biofeedback training as described in sham-biofeedback arm.
15842121|NCT04106492|Drug|SQ3370|SQ3370 consists of 2 components: SQL70, a protodrug-activating biopolymer, and SQP33, a protodrug of Doxorubicin
15842122|NCT04106479|Device|NIRS evaluation|NIRS will be used for measurement of cerebral and renal saturation.
15842123|NCT04106466|Device|Medtronic Summit RC+S DBS system|Open label active Deep Brain Stimulation (DBS)
15842124|NCT04106453|Procedure|navigated microwave ablation|the laparoscopic microwave ablation in the pig liver is performed with the CasOne-Spot system
15842125|NCT04106453|Procedure|ultrasound guided navigation|the laparoscopic microwave ablation iin the pic liver is performed with ultrasound guidance
15842126|NCT04106440|Behavioral|Application Use|Use applications after initial diagnosis to share information with study team.
15842127|NCT04106427|Device|continuous theta burst stimulation (cTBS)|"cTBS stimulation of 17 mins over right inferior parietal lobe (IPL) with two 44 s stimulations separated by 15 mins, 10 sessions in total (5 per week). intensity will be 100% of resting motor threshold at 30 Hz.
~administered in weeks 1 and 2 of the trial"
15842128|NCT04106427|Device|placebo cTBS|"Placebo stimulation of 17 mins over right IPL with two 44 s stimulations separated by 15 mins, 10 sessions in total (5 per week). intensity will be 0% of resting motor threshold at 30 Hz.
~administered in weeks 1 and 2 of the trial"
15842129|NCT04106427|Behavioral|social cognitive remediation therapy (SCRT)|16 sessions of group SCRT will be scheduled within 8 weeks, comprising 6-8 participants per group with 2 therapists. Duration of group sessions will be 60-90 mins. The content will follow the manual of SCRT and we will add a short intervention to practice the use of co-speech gestures at each session
15842130|NCT04106427|Behavioral|Sham group therapy|Group activities in closed groups of 6 participants. Schedule of two sessions per week for 8 weeks. Two therapists are guiding different leisure activities, e.g. group walks, going to museums/movies, games.
15842131|NCT04106414|Drug|Nivolumab|Nivolumab 480 mg every 4 weeks.
15842132|NCT04106414|Drug|BMS- 986205|BMS-986205 100 mg every 4 weeks.
15842133|NCT04106401|Other|carbon-monoxide rebreathing|Inhaled carbon monoxide (CO) administrated as a bolus into a rebreathing circuit serves as a marker to tag circulating hemoglobin molecules and to calculate total hemoglobin mass (Hbmass). The change in blood CO concentration from pre- to postadministration (delta carboxyhemoglobin concentration) and the dose of administrated CO allows for Hbmass determination. The other blood compartments (total red blood cell volume, plasma volume and total blood volume) are derived from Hbmass, hematocrit and/or hemoglobin concentration.
15842134|NCT04106401|Other|venous blood sampling|venous blood sampling at rest to evaluate blood viscosity, erythropoiesis and iron metabolism
15842135|NCT04106401|Other|physical activity monitoring|recording of physical activity by actimetry
15842136|NCT04106401|Other|apnea-hypopnea index and nocturnal oxygenation|recorded by ambulatory sleep recording device
15842137|NCT04106401|Other|24-hour blood pressure|recorded by ambulatory device
15842138|NCT04106388|Behavioral|Virtual Behavioral Health Integration|The virtual behavioral health integration program, implemented in primary care settings, is a structured mental illness treatment program that includes both behavioral treatment and counseling components aimed at reducing cost of care, developing and sustaining adaptive coping strategies, and improving short term acute care utilization.
15842139|NCT04106375|Behavioral|Online mindfulness based cognitive therapy intervention|MBCT is based on Mindfulness-Based Stress Reduction (MBSR), combining principles of cognitive therapy (CT) with those of mindfulness meditation to prevent depression relapse. Both MBSR and MBCT use contemplative practices, including sitting meditation, body scan and walking meditation, as core methods to teach awareness of negative thoughts and emotions with the aim of disengaging from pervasive patterns of ruminative self-centered mentation. Participants will be given an initial orientation session and then complete an online 8-week MBCT program. Each week participants will take part in one 2-hour online group session and will complete homework assignments anticipated to take 15-30 minutes per day to complete. Additionally, weekly phone coaching will be offered based on the modified tele-coach manual developed by Mohr and colleagues (Duffecy et al. 2010).
15842140|NCT04106362|Biological|Cetuximab|Given IV
15842141|NCT04106362|Drug|Cisplatin|Given IV
15842142|NCT04106362|Other|Quality-of-Life Assessment|Ancillary studies
15842143|NCT04106362|Other|Questionnaire Administration|Ancillary studies
15842144|NCT04106362|Radiation|Radiation Therapy|Undergo radiation therapy
15842145|NCT04106336|Device|rTMS|Repetitive transcranial magnetic stimulation (rTMS) will be done for cannabis addict
15842146|NCT04106310|Device|High-flux dialyzer|a dialyzer meeting the definition of high-flux
15842147|NCT04106310|Device|Theranova dialyzer|a middle cut-off dialyzer
15842148|NCT04106297|Drug|GLPG3970 oral solution|GLPG3970 for oral administration
15842149|NCT04106297|Drug|Placebo oral solution|Placebo for oral administration
15842150|NCT04106297|Drug|GLPG3970 capsule|GLPG3970 for oral administration
15842151|NCT04106271|Other|dyadic pain management program|a dyadic pain management program for older adults and their informal caregivers is developed as intervention. The program will be conducted at community activity center face-to-face combined with digital-based activities and the program will include 4 sessions, weekly 1 hours. Each session will be classified into three stages, including 10 minutes for watching videos and group discussion, 20 minutes for theoretical knowledge and coping skills and 20 minutes for exercising together. Last 10 minutes of each session is to wrap up and Q & A. There will be a brief introduction of program and self-introduction of participants at the beginning of the first session. One exercise book is given to each pair and researchers have a 4-week follow-up.
15842152|NCT04106258|Drug|Hemoporfin PDT|Photodynamic therapy is performed using hemoporfin under general anesthesia. Hemoporfin（5mg/kg）is infused for 20 minutes, followed by light illumination at 10 minutes from the start of infusion. Different light dose of PDT is applied to the patients.
15842153|NCT04106245|Behavioral|Behavioral Intervention|Participate in PACK Health
15842154|NCT04106245|Other|Survey Administration|Complete survey
15842155|NCT04106232|Other|No change in procedure except for specimen collection throughout procedure|Stool specimens will be taken before and during the HyGIeaCare procedure. Microbiome comparisons will be made across all specimens
15842156|NCT04106219|Drug|LY3295668 Erbumine|Administered orally.
15842157|NCT04106219|Drug|Topotecan|Administered IV.
15842158|NCT04106219|Drug|Cyclophosphamide|Administered IV.
15842159|NCT04106206|Drug|LY3372689|Administered orally
15842160|NCT04106206|Drug|Placebo|Administered orally
15842161|NCT04106193|Other|Blended Facilitation|Blended facilitation consists of an External Facilitator and Internal Facilitator to support adoption of intimate partner violence screening practices for WVs treated in primary care.
15842162|NCT04106193|Other|Implementation as usual|Implementation as usual refers to traditional, site-initiated support for screening practices to detect intimate partner violence among WVs treated in primary care.
15842163|NCT04106193|Other|Toolkit|All study arms will feature a toolkit meant to guide sites' adoption of intimate partner violence screening among WVs treated in primary care.
15842164|NCT04106180|Drug|GM-CSF|Patients will receive GM-CSF 125μg/m2 daily for 14 consecutive days after completing SBRT treatment.
15842165|NCT04106180|Drug|Sintilimab|Patients will receive Sintilimab 200 mg every 3 weeks up to 2 years after completing SBRT treatment.
15842166|NCT04106180|Radiation|SBRT|Patients will receive SBRT for one previously unirradiated primary or metastatic lesion (size: 1-5cm). 24 Gy in 3 fractions (8Gy/Fx) administered once-daily for 3 consecutive days.
15842215|NCT04105816|Device|892.1550 Ultrasonic pulsed doppler imaging system|Use of the ultrasound to measure quadriceps volume
15842168|NCT04106154|Behavioral|Kinesiology Support|12 week physical activity group led by Kinesiologist. The intervention will be used to increase confidence in the participants by providing physical activity education and a variety of activities.
15842169|NCT04106141|Other|6 weeks changing of archwire|changing the archwire after 6 weeks instead of 4 weeks
15842170|NCT04106141|Other|4 weeks changing of archwire|changing the archwire every 4 weeks
15842171|NCT04106128|Diagnostic Test|ultrasound examination|Measuring the thickening fraction by diaphragmatic ultrasound of acute diaphragmatic dysfunction in patients admitted for acute respiratory distress
15842172|NCT04106115|Drug|Durvalumab|1500 mg IV infusion every 4 weeks for up to 7 doses
15842173|NCT04106115|Biological|S-488210/S-488211|S-488210/S-488211 is given as a 1 mL subcutaneous (SC) injection of S-488210/Montanide emulsion and a 1 mL SC injection of S-488211/Montanide emulsion starting the day after first dose of durvalumab and continuing weekly for 6 doses and then every 2 weeks for a further 9 doses
15842174|NCT04106102|Device|Transcramial Direct current stimulation|Two sessions of 5 stimulations will be made on patient with obsessive-compulsive disorder
15842175|NCT04106102|Device|Placebo|Two sessions of 5 stimulations will be made on patient with obsessive-compulsive disorder without direct current. They xwill just wear electrodes.
15842177|NCT04106076|Biological|UCART123|Allogeneic engineered T-cells expressing anti-CD123 Chimeric Antigen Receptor
15842178|NCT04106063|Other|KID SSQ12 questionnaire|During a face to face interview (maximum 15 minutes), the child will complete a short questionnaire (KID SSQ12 questionnaire) to assess his auditory difficulties
15842179|NCT04106050|Drug|BIIB095|Administered as specified in the treatment arm.
15842180|NCT04106050|Drug|BIIB074|Administered as specified in the treatment arm.
15842181|NCT04106050|Drug|Placebo|Administered as specified in the treatment arm.
15842182|NCT04106050|Drug|Lidocaine|Administered as specified in the treatment arm.
15842183|NCT04106037|Other|Data extraction from medical files|Data extraction from medical files
15842184|NCT04106024|Drug|Anlotinib|Anlotinib 12mg.qd ,taken for 2 weeks and discontinued for 1 week, namely 3 weeks (21 days).
15842185|NCT04106011|Drug|Gabapentin|Titration of gabapentin will be standardized as 300mg QHS and increased by 300mg every 3 days until taking 1200mg TID or maximum tolerable dose. Subjects will undergo cognitive evaluation prior to initiation of the medication, at 1 week (when titrated to approximately 900mg/day), 3 weeks (when titrated to approximately 2100mg/day), and at 6 weeks (when titrated to 3600mg/day or maximum tolerable dose).
15842186|NCT04106011|Diagnostic Test|BTACT|Cognition measure: Brief Test of Adult Cognition by Telephone
15842187|NCT04106011|Diagnostic Test|BPI|Pain severity and interference at baseline using the Brief Pain Inventory
15842188|NCT04106011|Diagnostic Test|HADS|Assessment of depression and anxiety with the Hospital Anxiety and Depression Scale
15842189|NCT04106011|Diagnostic Test|SLP9|Assessment of Sleep
15842190|NCT04106011|Diagnostic Test|NPSI|Assessment of neuropathic components
15842191|NCT04105998|Drug|Oxytocin|Oxytocin 10 IU
15842192|NCT04105998|Drug|Placebo|Placebo
15842193|NCT04105985|Drug|Kovanaze Nasal Spray|Intra-nasal local anesthetic
15842194|NCT04105985|Drug|Articaine Injection|Local anesthetic
15842195|NCT04105972|Drug|ELX/TEZ/IVA|FDC tablet for oral administration.
15842196|NCT04105972|Drug|TEZ/IVA|Fixed-dose combination (FDC) tablet for oral administration.
15842197|NCT04105972|Drug|IVA|Mono tablet for oral administration.
15842198|NCT04105959|Drug|RIST4721|RIST4721 oral solution
15842199|NCT04105959|Drug|Placebo|Placebo oral solution
15842200|NCT04105946|Drug|Dexmedetomidine|dexmedetomidine administration intraoperatively in combination with other drugs used in OFA
15842201|NCT04105946|Drug|Remifentanil|remifentanil administration intraoperatively in combination with other drugs used in TIVA
15842202|NCT04105933|Other|CS-CBT|Culturally sensitive Cognitive Behavioural Therapy was delivered individually, focused on potential cultural beliefs and attitudes that might collide with core values of CBT.
15842203|NCT04105933|Other|CBT|CBT was delivered at an individual level, dealing with thoughts, feelings and behaviours in the present. Thoughts are identified and then challenged, to make them more objective and rational.
15842204|NCT04105920|Device|Hyaluronic acid arm|Patients included in this arm, will have, before insertion of brachytherapy seeds in the prostate, an injection of hyaluronic acid between the prostate, rectum, and pudendal arteries
15842205|NCT04105907|Device|GentleWave|Subject teeth will receive a partial root canal treatment with the Sonendo GentleWave system followed by extraction of the tooth and histological evaluation of the tooth
15842206|NCT04105894|Device|MSCT of nose and PNs|MSCT of nose and PNs axial, coronal and sagittal cuts without contrast to evaluate the state of the sinuses at the beginning of evaluation and after 2 months duration of medical treatment for GERD
15842207|NCT04105894|Diagnostic Test|Swab from nasal and oral mucous discharge to evaluate presence of HCL and pepsin|Swab from nasal and oral mucous discharge to evaluate presence of HCL and pepsin at the at the beginning of evaluation and after 2 months duration of medical treatment for GERD
15842208|NCT04105894|Drug|medical treatment of GERD t|medical treatment of GERD only for 2 months as described by gastroenterology department
15842209|NCT04105881|Dietary Supplement|Investigation|Cross sectional intervention
15842211|NCT04105842|Device|Delfilcon A|Participants wear delafilcon A contact lenses on a daily disposable basis.
15842212|NCT04105829|Other|Bond-a braid|Stainless steel lingual retainer application
15842213|NCT04105829|Other|EverStick-Ortho|Fiber reinforced lingual retainer
15842214|NCT04105829|Other|Ribbond|Fiber reinforced lingual retainer
15842216|NCT04105816|Diagnostic Test|Thigh circumference measurement|Tape measure used to measure thigh circumference of all participating patients in the study at the same visit in which they receive ultrasound measurements of thigh muscles.
15842217|NCT04105790|Behavioral|Cognitive Behavioural Therapy with Mindfulness classes|The standard CBTm protocol is comprised of four 90-minute classes offered virtually via videoconferencing once a week for four consecutive weeks. The classes cover topics including mindfulness, cognitive therapy principles, behaviour therapy principles, managing anger, assertiveness, problem solving, goal setting, and evidence-based self-help resources. They are lecture-based but also involve experiential elements, such as mindfulness activities and practice of cognitive therapy strategies. Participants are assigned daily homework between each class to practice the strategies taught in session.
15842218|NCT04105777|Device|Parenteral Nutrition Bag Eurotube|7-,8- or 9-chamber bags for individualized parenteral nutrition compounding.
15842219|NCT04105777|Device|Parenteral Nutrition 2/3 chamber Bag|Premixed 2/3-chamber bags which are eventually completed with other supplements shortly before administration by infusion into the bag.
15842220|NCT04105764|Drug|Rocuronium|DEEP block to PTC 1-3
15842221|NCT04105764|Drug|Rocuronium bromide|MODERATE block to TOF1-2
15842222|NCT04105751|Device|Novel Communication System|Small hand held device that aids in answering questions. Used in conjunction with a tablet computer.
15842223|NCT04105725|Behavioral|Brief Motivational Intervention+Substance-Free Activity Session|A dialogue with the individual of their own experiences with alcohol use and related problems, as well as academic/career goals and personal interests.
15842224|NCT04105725|Other|Alcohol + Nutrition Education Session|Education on alcohol, alcohol metabolism in the body, and alcohol overdose, as well as education on food groups and recommendations for a balanced diet.
15842225|NCT04105712|Behavioral|Dietary Change (low in highly processed foods)|For post-dietary change, food is provided for 3 days (participants provide own food and do food journals the other 2 days to confirm adherence). University of Michigan's Nutrition Obesity Research Center (NORC)'s Metabolic Kitchen prepares the food. Low HP food diet is based on prior methods where participants are placed on an isocaloric diet composed of 5% or less of calories from added sugar and 10% or less of overall calories from total sugar. No foods that meet the criteria for a HP food (defined by Kant and colleagues) that corresponds to: sweeteners (sugar, candy, etc); carbonated and non-carbonated beverages (fruit drinks, sweetened / diet beverages, etc.); baked / dairy desserts (cookies, ice cream, etc.); salted snacks (potato chips, etc.) and fast foods (pizza, cheeseburgers, etc.) are included in diet portions. The overall macro nutrient composition of the diet will be approximately 20-25% of kcal from protein, 30-35% of kcal from fat, and 40-50% of kcal from carbohydrates.
15842226|NCT04105699|Device|Blood sampling|Daily blood sample which will be taken for the PSP measurement using the abioSCOPE as well as another daily sample taken for central analysis of biomarkers of inflammation, infection and/or sepsis (including but not limited to C-reactive protein [CRP] and Procalcitonin [PCT]).
15842227|NCT04105686|Other|Control Infant Formula|Ready to feed infant formula, feed ad libitum
15842228|NCT04105686|Other|Experimental Infant Formula|Ready to feed infant formula, feed ad libitum
15842229|NCT04105673|Other|Clinical examination and survey|Children will be seen during an one consultation. A clinical examination and survey are realized.
15842232|NCT04105647|Behavioral|Lifestyle-integrated exercise|The experimental group will receive a face-to-face group session and a package of instant messages related to lifestyle-integrated exercise and physical activity. The lifestyle-integrated exercise is modified from Zero-time exercise. It focuses on four exercise domains that patients with lung cancer could be done at home, including breathing, balance, aerobic, strength, stretching exercises
15842233|NCT04105647|Behavioral|Healthy living information|The control group will receive a face-to-face group session and a package healthy living instant messages, but not related to lifestyle-integrated exercise and physical activity.
15842234|NCT04105634|Drug|FNOS|The imaging drug used for this group is called 18F-NOS, it is an experimental imaging drug that has not yet been approved by the Food and Drug Administration (FDA) for use except in a research study. Subject will not receive the results or feedback from the study participation, the images may be reviewed with subject or her/his doctor upon request but will not be used to make decisions about subject medical care.
15842235|NCT04105634|Drug|Florbetaben|The imaging drug used for this group is called Florbetaben, it is an FDA approved radioactive PET tracer used to image amyloid plaques in the body. Although not yet FDA approved for this purpose, it has already been used clinically to image amyloid in other parts of the body. Subject will not receive the results or feedback from the study participation, the images may be reviewed with subject or her/his doctor upon request but will not be used to make decisions about subject medical care.
15842236|NCT04105608|Dietary Supplement|High-fiber vegetarian meal|The intervention consisted in the administration of a high fiber vegetarian meal prepared by our research group staff.
15842237|NCT04105608|Dietary Supplement|Mediterranean-like meal|The intervention consisted in the administration of a Mediterranean-like meal prepared by our research group staff.
15842238|NCT04105595|Device|Septal defect closure|Device closure of atrial septal defect
15842239|NCT04105582|Biological|Neo-antigen pulsed Dendritic cell|Patients that have already finished their conventional treatment (chemotherapy and/or surgery) will be vaccinated with dendritic cells pulsed with synthetic peptide
15842240|NCT04105569|Procedure|Stent-Induced Biofilm Overgrowth|Customized acrylic dental (sextant) stent will be used during brushing for 21 days to influence reversible gingival tissue inflammation.
15842241|NCT04105556|Other|Nursing Care Based on Kolcaba's Comfort Theory|In this study, nursing care based on Kolcaba's Comfort Theory, which continues throughout the perioperative period, was applied to children and their parents.
15842242|NCT04105543|Drug|CLR 131|CLR 131 is a radiopharmaceutical dosed intravenously over a period of approximately 30 minutes, dose will be based on total body surface area calculated from actual body weight and height
15842243|NCT04105530|Device|Anodal tDCS treatment|The Anodal intervention excites neuronal activity. For condition one, the anode will be attached to the left frontal region (Fp1) and the cathode will be attached to the right neck. The intervention involves a direct current of 1 mA applied for 20 minutes.
15842244|NCT04105530|Device|Cathodal tDCS treatment|The Cathodal intervention inhibits or reduces neuronal activity. We propose that the use of the cathodal tDCS to the superior temporal gyrus in survivors of childhood ALL may facilitate the inhibition of over connected motor-sensory and auditory neural networks. For condition two, the cathode will be attached to the left temporal region (T3) and the anode will be attached to the right neck. The intervention involves a direct current of 1 mA applied for 20 minutes.
15842245|NCT04105530|Device|Sham treatment|The sham procedure provides the same small current during ramp up to imitate the intervention, but the current is discontinued after ramping up and no intervention is provided. Sham will be applied for 20 minutes. Stimulation will start 5 minutes before testing and continue throughout completing the NIH Toolbox Cognitive Battery at each trial.
15842246|NCT04105530|Other|NIH Toolbox List Sorting Working Memory Test|List Sorting is using information processing and storage. Performance tends to peak in early adulthood and then decline across the life span. This task assesses working memory and requires the participant to sequence different visually- and orally-presented stimuli. The list scoring task takes approximately 7 minutes to administer. List Sorting is scored by summing the total number of items correctly recalled and sequenced on Lists-1 and -2, which can range from 0-26.
15842247|NCT04105530|Other|NIH Toolbox Flanker Inhibitory Control and Attention Test|The Flanker tests inhibitory control and attention and the capacity for new learning and information processing novel situations. This performance also reaches a peak in early adulthood and tends to decline across the life span. A total of 40 trials require 4 minutes. Scoring is based on both accuracy and reaction time, which will we evaluate individually as well as in combination. The raw scores are converted to a scale score with a mean of 100 and SD of 15. Higher scores indicate higher executive function.
15842248|NCT04105530|Other|Grooved Peg Board Test|The Grooved Peg Board test measures visual-motor coordination and motor speed. Additionally, it is cognitively challenging and has been associated with attention, perceptual speed and non-verbal reasoning. Performance is better in the dominant/preferred hand and tends to improve in childhood and decline with advancing age. The test consists of placing metal pegs with ridges along onside in matching slots as quickly as possible. The score is the time in seconds required to compete the array with each hand. Longer times reflect worse performance. Times are compared to normative data that is organized by ethnicity, age, gender and education. The test takes approximately 5 minutes to complete.
15842249|NCT04105530|Other|Buschke Selective Reminding Test|This selective reminding task purports to distinguish verbal memory into short-term and long-term components. Scores are organized by short- and long-term storage and retrieval with normative scores organized by age and gender. The task requires participants to remember a list of orally-presented words and recall them with selective reminders of the words that they didn't recall. The test will last 5-10 minutes and is available in four different versions, thus reducing rehearsal effects.
15842250|NCT04105504|Drug|Glutathione|Oral glutathione capsule (500 mg), were taken once daily by the subjects.
15842251|NCT04105504|Drug|Placebo oral tablet|Placebo oral capsule were taken once daily by the subjects.
15842252|NCT04105491|Device|IInvisalign® Aligners|Clear aligner orthodontic treatment
15842253|NCT04105478|Procedure|Shoulder arthroplasty|Patients suffering from severe glenohumeral osteoarthritis are treated surgically by a total shoulder arthroplasty
15842254|NCT04105465|Device|PlasmaJet|The PlasmaJet device is used following groin node dissection on the side randomised to receive it as per protocol specifications
15842255|NCT04105426|Dietary Supplement|Antioxidants|one multivitamin and multimineral tablet with 500 mg grape seed extract once a day and one tablet of alpha-lipoic acid (300 mg ALA) twice a day for 3 months.
15842256|NCT04105426|Dietary Supplement|Placebo|one placebo tablet three times per day for 3 months.
15842257|NCT04105413|Diagnostic Test|Blood culturs|CBC, Blood culture and CRP
15842258|NCT04105387|Procedure|Early Tracheostomy Change|The treatment group will have the first tracheostomy change on postoperative day 4 by an Otolaryngology physician (attending or fellow) on the study team.
15842259|NCT04105374|Drug|Extended Release Flucytosine|Given PO
15842260|NCT04105374|Device|NovoTTF-100A Device|Receive Optune device
15842261|NCT04105374|Other|Quality-of-Life Assessment|Ancillary studies
15842262|NCT04105374|Other|Questionnaire Administration|Ancillary studies
15842263|NCT04105374|Radiation|Radiation Therapy|Undergo radiation
15842264|NCT04105374|Drug|Temozolomide|Given PO
15842265|NCT04105374|Procedure|Therapeutic Conventional Surgery|Undergo standard of care surgery
15842266|NCT04105374|Biological|Vocimagene Amiretrorepvec|Given via intracranial injection
15842267|NCT04105361|Procedure|Posterior neurectomy|Cut of posterior nasal nerve
15842268|NCT04105348|Diagnostic Test|HbA1c|patients with raised investigations will be included in group 1 patients with normal investigations will be included in group 2
15842269|NCT04105335|Drug|MTL-CEBPA|Intravenous administration
15842270|NCT04105335|Drug|Pembrolizumab|Intravenous administration
15842271|NCT04105322|Other|Kinesio Taping|The kinesio tape is adhesive and it does not contain drug substance. After the patients were randomized to the groups, kinesio tape will be applied to the relevant region.
15842272|NCT04105309|Behavioral|Implementation Intentions|"Implementation intentions aid in pre-planning and habitualization of behaviors, as they serve to identify the when, where, and how of behaviors leading to goal attainment. Often taking the form of If/when situation x arises, then I will do y!, implementation intentions can be conceptualized in two parts, namely, an environmental or internal retrieval cue and a goal-directed behavioral response. Implementation intentions are effective because they 1) create a strong association between a retrieval cue and a goal-aligned behavior, increasing the likelihood that the goal-aligned behavior will be retrieved and utilized when the cue is encountered, and 2) increase attention for and cognitive accessibility of the retrieval cue, increasing opportunities for goal-aligned action ."
15842273|NCT04105309|Behavioral|Fluency Training|Fluency training is a learning strategy that requires an individual to perform a skill or demonstrate knowledge repeatedly for both accuracy and response rate; the goal is to enhance automaticity of the response and promote endurance and retention of skills and knowledge over time and in the face of distractors. Participants completed 1 minute fluency training protocol 4 times throughout the study.
15842274|NCT04105309|Behavioral|Text Messages|SMS reminders sent to phone of implementation intentions 16 times throughout the study.
15842275|NCT04105309|Behavioral|Goal Intentions|Intentions to complete a goal that do not specify a plan about how to do so (compared to implementation intentions, that do)
15842276|NCT04105296|Device|EKSO+ES|6 months of exoskeleton training with epidural stimulation.
15842277|NCT04105283|Biological|Tc99m-MAA|Tc99m-MAA is a particle that is used to assess blood flow distribution and has a similar size to the particles that are utilized for arterial delivery of radiation therapy, also called radioembolization. Tc99m-MAA is currently used to estimate radiation dosimetry prior to arterial radiotherapy administration for liver malignancies.
15842278|NCT04105270|Drug|Oral Restorative Microbiota Therapy (RMT) Capsules|Patients with PD-L1 TC expression will receive sixteen doses of oral RMT capsules weekly
15842279|NCT04105270|Drug|Durvalumab 1500 mg IV|Patients with PD-L1 TC expression receive durvalumab 1500 mg IV every 4 weeks (Q4W) until disease progression or for a maximum of two years from the 1st dose of durvalumab
15842280|NCT04105270|Drug|Cisplatin/pemetrexed or Carboplatin/pemetrexed|Patients with PD-L1 TC receive cisplatin/pemetrexed or carboplatin/pemetrexed given every 3 weeks (Q3W) for 4 cycles followed by pemetrexed maintenance given Q3W
15842281|NCT04105270|Other|Placebo|Sixteen doses of oral placebo capsules given weekly
15842282|NCT04105257|Diagnostic Test|All patients|Comparison of the results of the CTP with MRI
15842283|NCT04105244|Behavioral|Resourcefulness Training©|The intervention includes self-help and help-seeking skills.
15842284|NCT04105231|Drug|Cannabidiol|Cannabidiol oral suspension
15842285|NCT04105231|Drug|Risperidone|Risperidone, encapsulated tablet.
15842286|NCT04105218|Behavioral|Exercise|Participants will perform 4 study visits over 1-3 months. The 1st study visit is a screening visit, during which eligibility will be determined. During the 2nd visit, resting metabolic rate (RMR) and body composition will be measured. Participants will also perform a submaximal exercise test. Prior to each condition, habitual sleep/wake patterns will then be measured for 1 week. Participants will then perform each of the 2 study conditions (evening exercise and control) in randomized order with at least a 1-week washout period between conditions. Females will be studied during the luteal phase to control for potential confounding effects of hormonal variations across the menstrual cycle.
15842287|NCT04105205|Drug|Apramycin injection|30-min infusion
15842288|NCT04105205|Drug|Placebo injection|30-min infusion
15842289|NCT04105192|Dietary Supplement|dietary supplement consumption|Consumption of the product under study for 84 days, plecebo or experimental product
15842290|NCT04105179|Device|Zimmer NexGen LPS-Flex|Patients will be randomly assigned to 1 of 2 devices
15842291|NCT04105179|Device|Smith & Nephew Journey II|Patients will be randomly assigned to 1 of 2 devices
15842292|NCT04105166|Biological|RP-L301|Autologous genetically modified CD34+ hematopoietic stem cells containing the corrected PKD gene
15842293|NCT04105140|Drug|Oxytocin|intranasal administration of oxytocin (24 IU)
15842294|NCT04105140|Drug|Placebo|intranasal administration of placebo (24 IU)
15842295|NCT04105127|Device|orthodontic - Anterior resin builds-ups|After lower brackets placement, resin builds-ups are added on the palatal aspect of the upper central incisors. Both central incisors are customarily bonded to broadly distribute the occlusal forces. Builds-ups are removed when the overbite was considered adequate to prevent lower brackets detachment.
15842296|NCT04105127|Device|orthodontic - Posterior resin builds-ups|After lower brackets placement, resin builds-ups are added on the supporting cusps of first or second upper/lower molars. Builds-ups are removed when the overbite was considered adequate to prevent lower brackets detachment.
15842297|NCT04105114|Drug|Buspirone|Oral Buspirone 7.5mg - 10mg daily during the treatment phase.
15842298|NCT04105114|Device|Non-invasive Spinal Cord Stimulation|A non-invasive transcutaneous electrical spinal cord stimulator, which can be used a multiple spinal locations.
15842299|NCT04105114|Device|Ekso Bionics Exoskeleton|This robotic exoskeleton is designed to assist people with neurological injuries for balance, standing, and stepping overground.
15842300|NCT04105114|Device|Gravity Neutral Device|This device is used to train and assess non-weight bearing stepping movements. When using the device, participants will be lying on their side with their legs suspended off the end of a table supported by small slings that are anchored securely to the apparatus.
15842301|NCT04105114|Device|Body Weight Supported Treadmill Training|Participants will be supported by a special harness while they are stepping on a treadmill. Trained technicians or therapists will be assist the trunk and legs during stepping as needed.
15842302|NCT04105114|Device|Rolling Walker|A standard rolling walker will be used for balance support and stability during stepping overground.
15842303|NCT04105101|Device|Industrial passive shoulder exoskeleton|Both exoskeleton types are passive shoulder exoskeletons. The goal is to compare the human response to the simulated industrial tasks between the different exoskeleton conditions.
15842306|NCT04105049|Other|Observation of psychological aspects|Motivational, socioeconomic, family, stress, and other aspects are tested.
15842307|NCT04105036|Other|Data Collection|Telephone interview questionnaire, in-home face-to-face interview, and data from the Collection Site
15842308|NCT04105023|Dietary Supplement|genistein|Administered orally once every 12 hours
15842309|NCT04105023|Dietary Supplement|Placebo|Administered orally once every 12 hours
15842310|NCT04105010|Drug|AZD4205|AZD4205 will be administered orally as capsules. AZD4205 treatment will be continued until disease progression or intolerant adverse reactions
15842311|NCT04104997|Drug|5% GLH8NDE|5% GLH8NDE as eye drops
15842312|NCT04104997|Drug|Placebos|Placebo as eye drops
15842313|NCT04104984|Device|transvaginal ultrasound|a transvaginal ultrasound is done to patient to determine cervical length
15842314|NCT04104984|Drug|Progesterone Vaginal Suppository|a progesterone vaginal suppository to prevent preterm labour
15842315|NCT04104984|Procedure|cervical cercalage|Mcdonald's cervical cercalage . a stitch taken around the cervix to prevent preterm labour
15842316|NCT04104984|Other|digital vaginal exam|vaginal examination to detect short cervix
15842317|NCT04104984|Device|abdominal ultrasound|use abdominal ultrasound to measure cervical length
15842320|NCT04104958|Genetic|qRTPCR (mRNA level).|RNA extraction and RT-qPCR Protein extraction and western blotting ELISA assay
15842321|NCT04104945|Radiation|De-intensified chemoradiotherapy|Radiotherapy to a dose of 60 Gy to the primary tumour and involved lymph nodes and 54 Gy to subclinical regions at risk in 30 fractions. Reduced volume of elective nodal radiation.
15842322|NCT04104932|Procedure|Open reduction and internal fixation|Open reduction and internal fixation
15842323|NCT04104919|Drug|Brivoligide Injection 660 mg/6 mL|Single preoperative intrathecal injection
15842324|NCT04104919|Drug|Placebo 6 mL|Single preoperative intrathecal injection
15842325|NCT04104906|Other|motor control training|The volunteers of the motor control group will initiate the exercises on a stable and rigid basis. These will be progressed with adding an unstable base as the volunteer gains motor learning (between the fourth and fifth week of the protocol). For the motor control group, two sets of 10 repetitions will be performed keeping in isometry for ten seconds each repetition.
15842326|NCT04104906|Other|The exercise group|the protocol of strengthening and will have five elastic bands with different resistances available (extra-light, light, moderate, strong and extra-strong) for elbow flexion exercises progression, medial rotation and lateral rotation of the shoulder and scapular retraction.
15842327|NCT04104893|Drug|Pembrolizumab|Pembrolizumab is a programmed death receptor-1 (PD 1)-blocking antibody. Pembrolizumab is a humanized monoclonal IgG4 kappa antibody with an approximate molecular weight of 149 kDa. Pembrolizumab is produced in recombinant Chinese hamster ovary (CHO) cells.
15842328|NCT04104880|Device|Continuous positive airway pressure (CPAP)|Adults previously diagnosed with obstructive sleep apnoea will receive a three-month CPAP intervention
15842329|NCT04104867|Drug|Itopride|the patients are instructed to take one pill of Itopride at 8.00 AM, 12.00 AM, 4.30 PM respectively before the dat of colonoscopy. Lastly, they are instructed to take the fourth pill at 6.00 AM on the day of colonoscopy.
15842330|NCT04104867|Drug|Domperidone|the patients are instructed to take one pill of Domperidone at 8.00 AM, 12.00 AM, 4.30 PM respectively before the dat of colonoscopy. Lastly, they are instructed to take the fourth pill at 6.00 AM on the day of colonoscopy.
15842331|NCT04104867|Other|Placebo|the patients are instructed to take one pill of placebo at 8.00 AM, 12.00 AM, 4.30 PM respectively before the dat of colonoscopy. Lastly, they are instructed to take the fourth pill at 6.00 AM on the day of colonoscopy.
15842332|NCT04104854|Device|drug coated balloon|Balloon/vessel diameter ratio 0.8-1.0, 8-12 ATM (atmosphere), lasting for >30 seconds
15842333|NCT04104841|Behavioral|Behaviorally Enhancing Adolescents' Mood in Schools|8-session modified behavioral activation intervention
15842334|NCT04104841|Behavioral|Usual Care|Referral to school mental health provider, social worker, or community care.
15842335|NCT04104828|Biological|Allergovit|Grass/tree-allergen extract with aluminium adjuvant for treatment of allergic rhinitis
15842336|NCT04104828|Biological|Polvac|Grass/tree-allergen extract with MCT adjuvant for treatment of allergic rhinitis
15842337|NCT04104828|Biological|Pollinex Quattro|Grass/tree-allergen extract with MCT-MPLA adjuvant for treatment of allergic rhinitis
15842338|NCT04104815|Other|Experimental Thickener|Use to thicken liquids
15842339|NCT04104802|Device|MRI|"All patients included will benefit from both methods of assessing anatomical relationships between the facial nerve and the parotid tumor:
~1) New medical imaging technique evaluated: 3 Tesla Parotidic MRI High Resolution with Specific Sequences and Gadolinium Injection 2) Standard Gold: Intraoperative Exam"
15842340|NCT04104789|Drug|Kovanaze Nasal Spray|Intra-nasal local anesthetic
15842341|NCT04104789|Drug|Articaine Injection|Local anesthetic
15842342|NCT04104776|Drug|CPI-0209|CPI-0209 alone
15842343|NCT04104776|Drug|Irinotecan|CPI-0209 in combination with irinotecan
15842344|NCT04104763|Behavioral|study of osteofibrous dysplasia features|obtain long term follow-up in patients with osteofibrous dysplasia, to assess natural history of the disease, late results of treatment and in particular the potential and risk of progression to adamantinoma.
15842345|NCT04104750|Other|assessment scales (BFI, QLQ, TESS)|the patient's Fatigue will be measured during the treatment period with antiblastic drugs and part of the followup period. To this end the BFI scale validated in Italian will be used (Mendoza et al 1999; Catania et al, 2013) which includes 9 items with a score for each of 0 to 10 and a consequent total score from 0 to 90. The measurement will take place in 4 times: the day of enrollment, 6 months, 12 months and 24 months after enrollment.the quality of life of patients measured by the EORTC QLQ C-30 scale (Aaronson et al, 1993) and the level of autonomy measured by the TESS scale (Davis et al, 1996) in 4 steps: the enrollment day , at 6 months, at 12 months and at 24 months from enrollment.
15842346|NCT04104737|Device|Spire Medical Health Tag|"Collect data to validate the respiratory rate performance of the Medical Health Tag developed by Spire Health. The Medical Health Tag respiratory rate will be evaluated during non-motion conditions over the range a range of 5-50 breaths per minute via Reference EtCO2.
~A FDA cleared, GE Healthcare S5 Multi-parameter monitoring system with End Tidal Carbon Dioxide (EtCO2) and 3- lead ECG will be used for the Respiratory and Pulse Rate References."
15842347|NCT04104724|Other|Self-help|self-help materials - cognitive behavioural and compassion-focused; psychoeducation, practical help re. attending cervical cancer screening
15842348|NCT04104711|Other|Home visits, health education|
15842349|NCT04104698|Diagnostic Test|Quantitative EEG|"Both groups will undergo evaluation of depression severity using Beck Depression Inventory Scale-II (Arabic Version)
~Both groups will be assessed for psychological & cognitive contributes respectively using:
~A. Connor and Davidson Scale for resilience (Arabic Version) B. The scale of Islamic Religiosity Attitude (SIRA)
~Both groups will do Quantitative EEG (qEEG) to detect electrical, functional and brain mapping changes {Using Neurovirtual BW III, Florida, USA)
~The quantitative analysis of EEG will focus on the following functions:
~Histogram, Topography, Spectrum Analysis, Spectral Differences, Propagation, Positional Diagram, Medium Amplitude, Ranges of Absolute Frequencies, Ranges of Relative Frequencies, CSA, Spectrum, and CSA Compressed."
15842350|NCT04104685|Combination Product|FCD105|Experimental combination
15842351|NCT04104685|Drug|3% Minocycline Foam|Active Comparator
15842352|NCT04104685|Drug|0.3% Adapalene Foam|Active Comparator
15842353|NCT04104685|Other|Vehicle Foam|Placebo
15842354|NCT04104672|Drug|AB680|AB680 is a Cluster of Differentiation (CD)73 Inhibitor.
15842557|NCT04102995|Drug|Sepranolone injection high dose|Subcutaneous (SC) administration
15842355|NCT04104672|Drug|Zimberelimab|Zimberelimab is a fully human immunoglobulin G4 (IgG4) monoclonal antibody targeting human PD-1.
15842356|NCT04104672|Drug|Nab-paclitaxel|Nab-paclitaxel is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.
15842357|NCT04104672|Drug|Gemcitabine|Gemcitabine is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.
15842358|NCT04104659|Drug|MK 6240|"PET tracer, [18F]MK-6240 (an[18F]tau imaging agent,CerveauTechnologies)that has high affinity for the human phosphorylated tau deposits in AD brain offers new opportunities to investigate tau pathology.(Hostetler, Walji et al. 2016, Lohith, Bennacef et al. 2016, Walji, Hostetler et al. 2016, Lohith, Bennacef et al. 2017, Neelamegam, Yokell et al. 2017).We will evaluate this imaging agent in individuals from families with a known Autosomal Dominant Alzheimer's Disease (ADAD) mutation.
~The planned dosage for [18F]MK-6240 is a single intravenous bolus injection of 185 MBq (5.0 mCi) in a large peripheral vein followed by a 10 mL normal saline (0.9% NaCl) flush."
15842359|NCT04104646|Drug|CHF6563|Sublingual CHF6563 administration at starting dose of 10 µg/Kg q8
15842360|NCT04104646|Drug|Morphine|Oral morphine administration at starting dose of 0.07 mg/Kg q4
15842361|NCT04104646|Drug|CHF6563 matched placebo|Sublingual CHF6563 matched placebo administration
15842362|NCT04104646|Drug|Morphine matched placebo|Oral morphine matched placebo administration
15842363|NCT04104633|Procedure|Blood samples|30 ml of blood collection
15842364|NCT04104607|Drug|CC-1, PSMAxCD3|Infusion of CC-1 over 24 hours for 7 days with possible intra-patient dose-escalation
15842365|NCT04104594|Diagnostic Test|Sniffin Stick Test|"The test consists of odorous rods that are presented to the patient's nose. It consists of 3 parts different, with 3 sets of corresponding sticks: an olfactory threshold test, an olfactory discrimination test and an olfactory identification test.
~The final score, out of 48, is the sum of the olfactory threshold, discrimination and identification scores. Normal test values are defined as greater than the tenth percentile of the general population, so the test result is compared to reference values on a chart to determine whether the patient is normosmic, hyposmic or anosmic."
15842366|NCT04104594|Other|numerical evaluation scale for olfaction|numerical rating scale from 0 (no smell) to 10 (perfect smell)
15842367|NCT04104594|Other|numerical evaluation scale for nasal obstruction|numerical rating scale from 0 (no freedom of the nasal passages) to 10 (maximum nasal freedom)
15842368|NCT04104594|Other|nasal outcome test|"list of symptoms and social/emotional consequences of rhino-sinusitis. 16 questions that the patient must code from no problem to serious problem over the last 15 days"
15842369|NCT04104594|Biological|dosage of 17 cytokines|dosage of 17 cytokines : G-CSF, GM-CSF, IFN-γ, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12 (p70), IL-13, IL-17A, MCP-1 (MCAF), MIP-1β,TNF-α
15842370|NCT04104581|Other|Control Refined Grain Diet|Subjects will be fed the average American diet except it will be free of whole grains
15842371|NCT04104581|Other|Low Whole Grain Oat Diet|Subjects will be fed the average American diet with addition of a low level of whole grain oats
15842372|NCT04104581|Other|High Whole Grain Oat Diet|Subjects will be fed the average American diet with addition of a high level of whole grain oats
15842373|NCT04104581|Other|Low Whole Grain Wheat Diet|Subjects will be fed the average American diet with addition of a low level of whole grain wheat
15842374|NCT04104581|Other|High Whole Grain Wheat Diet|Subjects will be fed the average American diet with addition of a high level of whole grain wheat
15842375|NCT04104568|Behavioral|iSupport for dementia - European-Portuguese version|iSupport for dementia, European-Portuguese version consists in an online self-help training and support program developed by the World Health Organization to to provide education, skills training and support to informal caregivers of people with dementia and culturally adapted to Portugal by the Institute of Biomedical Sciences Abel Salazar and CINTESIS. Framed as a multi-component intervention, iSupport is grounded in problem-solving and cognitive behavioral therapy techniques. The program comprises 23 lessons on dementia and caregiver support distributed by 5 modules: 'Introduction to dementia'; 'Being a carer'; 'Caring for me'; 'Providing everyday care' and 'Dealing with behavior changes'. The education plan can be personalized by the caregiver and each lesson includes interactive exercises with immediate feedback; and positive messages as well as 'skills certificates' are displayed when lessons are completed.
15842376|NCT04104568|Other|e-book (comparator)|The e-book contains information on relevant topics for dementia and caregiving, including basic information about dementia; practical tips on managing dementia; the changing needs of a person with dementia; dealing with care provision; caring for oneself (the caregiver) and finding emotional support; dealing with the death of the care receiver; relevant legislation (e.g. advance directives); how to get help; and how to reach the national Alzheimer's Association.
15842377|NCT04104555|Other|Birthday card|Birthday card sent to participants in the post
15842378|NCT04104555|Other|Birthday card plus nudge|Birthday card plus nudge sent to participants in the post
15842379|NCT04104555|Device|Prefabricated orthoses|Prefabricated insole
15842380|NCT04104555|Device|Custom orthoses|Custom made orthoses
15842381|NCT04104555|Other|Pen|Pen included in the participant OSTRICH recruitment pack
15842382|NCT04104555|Other|Signposting to multimedia|Signposting to multimedia information in the patient information sheet which is sent to participants in the post as part of the OSTRICH recruitment pack.
15842383|NCT04104555|Other|Pen and signposting to multimedia|Pen and signposting to multimedia information in the patient information sheet which is sent to participants in the post as part of the OSTRICH recruitment pack.
15842384|NCT04104555|Other|Usual supportive care - exercises and footwear advice (the comparator)|Active comparator
15842385|NCT04104542|Behavioral|Mindfulness based stress reduction|on-line training on the website = www.palousemindfulness.com
15842386|NCT04104542|Behavioral|Healthy Lifestyle|Diet and Exercise
15842387|NCT04104529|Other|Biological collection|The biological collection will also include samples of blood samples collected before and during treatment.
15842388|NCT04104503|Drug|Lu AF11167|Lu AF11167 - 2 mg modified release tablets (reference formulation), up to 5 prototype MR tablet formulations (test formulations)
15842389|NCT04104503|Drug|[14C]-Lu AF11167|single iv microdose administered as a 15 minutes infusion
15842390|NCT04104503|Drug|Lu AF11167 MR tablet prototype formulation selected from part A or 1 mg modified release tablet (reference formulation)|Single oral dose
15842391|NCT04104477|Other|Range of Motion Tasks|Participants will perform range of motion (thumb only) to evaluate fine and gross motor function.
15842392|NCT04104477|Other|Strength Tasks|Participants will perform strength (pinch and grip) tests to evaluate fine and gross motor function.
15842394|NCT04104438|Drug|Basiliximab 20 MG|Basiliximab induction followed by tacrolimus, corticosteroids and mycophenolic acid with a switch to everolimus by post operative day 30
15842395|NCT04104412|Biological|human umbilical cord mesenchymal stem cell|2*10^7
15842396|NCT04104399|Drug|XC101-D13H|XC101-D13H supplied as 0.4, 0.8, 1.6 or 3.2 mg dose, administered in capsules
15842397|NCT04104399|Drug|Placebo|Placebo supplied as matching capsules
15842398|NCT04104386|Other|Telomere Disclosure Impact|Participants were either provided or not provided information about their personal telomere length and how they compared to the rest of the sample.
15842399|NCT04104373|Other|Observational Cohort|
15842400|NCT04104360|Dietary Supplement|Galacto-oligosaccharides|During this period subjects will receive 7.2 grams of Vivinal GOS supplements three times daily for four weeks
15842401|NCT04104360|Dietary Supplement|Maltodextrin|During this period subjects will receive 7.2 grams of maltodextrin supplements three times daily for four weeks
15842402|NCT04104347|Other|Metacognitive training (MCT)|Metacognitive Training (MCT) was first developed in Germany in 2007 by Steffen Moritz and Todd Woodward (Moritz & Woodward, 2007) targeting positive psychotic symptoms of patients with schizophrenia. MCT aims to change cognitive biases leading to delusional beliefs and consists of ten group sessions focused on different topics (Modules) as follows: Attributional Style (Module 1), Jumping to Conclusions (Modules 2 and 7), Changing Beliefs (Module 3), Empathy (Modules 4 and 6), Memory (Modules 5), Depression and Self-Esteem (Module 8) and two additional modules, namely Self-Esteem (Module 9) and Stigma (Module 10). Modules 8 (Self-Esteem), 9 (Self-Esteem) and 10 (Stigma) can be delivered together as one session so the intervention totals eight weekly group (3-10 participants) sessions. The MCT manual is available at: http://www.uke.de/mkt and was directly supervised by Steffen Moritz.
15842403|NCT04104347|Other|Support group|Controls will attend eight weekly support groups. Seven group sessions will focus on the following topics: 1) basic activities of daily living (BADL), 2) instrumental activities of daily living (IADL), 3) physical health, 4) press-based work, 5) psychoeducation on emotions, 6) psychoeducation on illness, 7) social and family relationships. One additional session will give participants some time to openly raise general issues and concerns which were not discussed during the above sessions. Controls will be encouraged to attend these group sessions from which they are likely to benefit. While not an intervention as such, this should turn into enough incentive to reach similar attendance rates in both arms of the RCT.
15842404|NCT04104334|Drug|Remifentanil infusion, desflurane titration and fluid infusion will be guided by NOL index, BIS index and Flotrac EV1000 system respectively|NOL index will guide the administration of remifentanil to keep the index between 5-25, and the desflurane will be titrated to keep a BIS index between 45 and 55. Cardiac output and stroke volume variation will be measured by the Flotrac EV1000 system. Patients will receive 250ml fluid challenges with a recommended solution as required, in order to achieve a maximal value of stroke volume
15842405|NCT04104334|Drug|Remifentanil infusion and desflurane titration will be guided by anesthesia usual practices|Desflurane will be administered to keep MAC at 1, and remifentanil infusion rate will be adapted to the mean arterial blood pressure to keep it between 65 and 100, according to anesthesia usual practices
15842408|NCT04104295|Diagnostic Test|Ultrasound following X-ray|A short (less than 10 minutes) ultrasound (US) scan of the abdomen within 2 hours of the routine X-ray (XR). The performer will be a physician who received a focused training on relevant US views, blinded to the XR image and report.
15842409|NCT04104269|Diagnostic Test|Heart rupture|Free wall rupture and Ventricular septal rupture
15842410|NCT04104256|Behavioral|Nudge #1: Alert highlighting the safety/potential harms to patients of undergoing pre-op tests|"Nudge 1:
~UCLA Ophthalmologists and Anesthesiologists ADVISE AGAINST routine pre-op testing.
~UCLA Pre-op Eval and Planning Center (PEPC) will order any needed labs on the day of surgery.
~Routine pre-op tests are inappropriate.
~Routine pre-op tests do NOT increase patient safety and go AGAINST local and national guidelines Hard stop before allowing the ordering of a pre-op test where physicians must provide accountable justification: EXPLAIN WHY GOING AGAINST GUIDELINES"
15842411|NCT04104256|Behavioral|Nudge #2: Alert highlighting the financial harms to the patient experiencing pre-op tests|"Nudge #2:
~UCLA Ophthalmologists and Anesthesiologists ADVISE AGAINST routine pre-op testing.
~UCLA Pre-op Eval and Planning Center (PEPC) will order any needed labs on the day of surgery.
~Routine pre-op tests are inappropriate.
~Routine pre-operative tests can increase the patient's out-of-pocket costs without improving the safety or medical outcomes of cataract surgery and go AGAINST local and national guidelines
~Nudge includes hard stop before allowing the ordering of a pre-op test where physicians must provide accountable justification: EXPLAIN WHY GOING AGAINST GUIDELINES"
15842412|NCT04104256|Behavioral|Nudge #3: Alert highlighting potential psychological harms to the patient of experiencing pre-op tests|"Nudge 3:
~UCLA Ophthalmologists and Anesthesiologists ADVISE AGAINST routine pre-op testing.
~UCLA Pre-op Eval and Planning Center (PEPC) will order any needed labs on the day of surgery.
~Routine pre-op tests are inappropriate.
~Routine pre-operative tests can cause aggravation and psychological stress for the patient without improving the safety or medical outcomes of cataract surgery and go AGAINST local and national guidelines
~Hard stop before allowing the ordering of a pre-op test where physicians must provide accountable justification: EXPLAIN WHY GOING AGAINST GUIDELINES"
15842413|NCT04104256|Other|Usual Care|Patients will receive usual care from their physicians.
15842414|NCT04104243|Other|Men-Tailored DPP (Power-Up)|Evaluating whether a diabetes prevention program (DPP) tailored for men (Power-Up) will show better or similar percent weight loss and retention than a standard mixed-gender DPP
15842415|NCT04104217|Behavioral|Music therapy|Music therapy sessions may last 20-60 minutes, with length and frequency to be determined mutually (generally 1-3 times per week). Music therapy sessions are done at the patient's bedside, where the music therapist plays live music on a guitar, keyboard, harp, or percussion instrument, sometimes as accompaniment to singing.
15842555|NCT04103008|Diagnostic Test|Speckle tracking echocardiography|assess left ventricular function on admission and after 40 days
15842416|NCT04104217|Behavioral|Interviews|Each interview will be conducted in person in a private setting (with the exception of caregivers, who have the option to conduct interviews over the phone if it is not feasible to take place in the hospital). Each interview will follow a semi-structured interview guide and will ask for consent to audio record the interviews .
15842417|NCT04104204|Drug|Intrathecal morphine|0.5% Iso/Hyperbaric bupivacaine 2-3 ml add morphine 0.1 mg for spinal anesthesia
15842418|NCT04104204|Drug|Ultrasound guided supra-inguinal fascia iliaca block|Ultrasound guided supra-inguinal fascia iliaca block with 0.25% bupivacaine 40 ml and 0.5% Iso/Hyperbaric bupivacaine 2-3 ml without spinal morphine for spinal anesthesia
15842419|NCT04104191|Device|L-1000AF System|The L-1000AF System is a wrist worn system that analyzes pulse rate data. The system identifies atrial fibrillation rhythms.
15842420|NCT04104178|Drug|Clindamycin|Investigating whether a significantly higher number of MRSA throat carriers succeed in becoming MRSA free, when using Clindamycin on top of our general recommended topical treatment of Mupirocin nasal ointment + chorhexidin baths
15842421|NCT04104178|Drug|Placebo|Placebo
15842422|NCT04104165|Device|Foley Catheter|Foley catheter used for treatment of urinary retention
15842423|NCT04104152|Other|CSD1902-11|A 2.4% nicotine ENDS product
15842424|NCT04104152|Other|CSD1902-12|A 2.4% nicotine ENDS product
15842425|NCT04104152|Other|CSD1902-13|A 2.4% nicotine ENDS product
15842426|NCT04104152|Other|CSD1902-14|A 2.4% nicotine ENDS product
15842427|NCT04104152|Other|CSD1902-21|A 5.0% nicotine ENDS product
15842428|NCT04104152|Other|CSD1902-22|A 5.0% nicotine ENDS product
15842429|NCT04104152|Other|CSD1902-23|A 5.0% nicotine ENDS product
15842430|NCT04104152|Other|CSD1902-24|A 5.0% nicotine ENDS product
15842431|NCT04104139|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo 3D-CRT
15842432|NCT04104139|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
15842433|NCT04104139|Drug|Trifluridine and Tipiracil Hydrochloride|Given PO
15842434|NCT04104126|Other|Standard of Care Physical Therapy|Will receive standard of care physical therapy
15842435|NCT04104126|Other|Blood flow restriction|Blood flow restriction therapy is a blood pressure cuff placed around the desired limb with a handheld device that controls the pressure exerted by the cuff. The cuff is placed around the desired limb before a specific exercise, the physical therapist determines the appropriate pressure and time, and the patient completes the exercise as they normally would. The monitor determines the limb occlusion pressure and has an automatic timer that will deflate after the specified time has elapsed.
15842436|NCT04104113|Other|Modified Xiang Bei Yang Rong Tang|Modified Xiang Bei Yang Rong Tang is a combination of 15 herbal components and it is available in granules form to be dissolved in hot water for consumption
15842437|NCT04104113|Other|Placebo|Placebo granules contain 5% XBYRT, colourant, bitterant and 95% starch filler
15842438|NCT04104087|Procedure|tunneling technique with sub epithelial connective tissue graft or deepithelialized free gingival graft.|enhancing papillary hight and treating gingival recession RT2 by performing tunneling technique with sub epithelial connective tissue graft or deepithelialized free gingival graft.
15842439|NCT04104074|Radiation|Radiotherapy|"Arm 1: The single radiotherapy dose was 200cGy, once a day, and the total dose was 5000cGy.
~Arm 2: the single dose of radiotherapy was 300 cGy, once a day, and the total dose was 3000 cGy."
15842440|NCT04104074|Drug|Sintilimab|Sintilimab is a PD-1 inhibitor, intravenously, at a dose of 200 mg, once every 3 weeks
15842441|NCT04104061|Other|iron profile|blood test
15842442|NCT04104022|Behavioral|Prolonged Exposure Therapy|Within the general population, prolonged exposure therapy (PET) is a widely-used, empirically-supported and manualized therapy that is regarded as a first-line cognitive-behavioral treatment for posttraumatic stress disorder (PTSD). PET is designed to disrupt the cycle of anxiety and avoidance that characterizes PTSD via sustained imaginal and in-vivo exposure exercises that deliberately and systematically expose patients to painful memories and current, real-life trauma reminders that were previously avoided, yet not inherently harmful. Overall, PET has well-documented efficacy for reducing PTSD symptom severity in both civilian and veteran populations. PET is effective for reducing PTSD symptoms regardless of whether it is delivered remotely or face-to-face. Recent data also suggest that PET can improve PTSD symptoms without exacerbating substance use or craving among patients with substance use disorders when PET and substance use disorder treatment are delivered concurrently.
15842443|NCT04104022|Behavioral|Attendance-based monetary incentives|Participants will earn vouchers that have monetary value for attending scheduled PET appointments. Each consecutive attended session will increase the voucher amount so that each consecutively attended appointment is worth an incrementally higher dollar amount. To support completion of the full 12-week PET protocol, we will also incorporate additional strategically-placed bonuses into the reinforcement schedule with the goal of maximizing the percentage of subjects who complete the full 12-session protocol. First, to support consistent (vs. sporadic) attendance, participants will receive a bonus for every two consecutive sessions attended. Second, to support completion of the full PET protocol, participants will receive an additional bonus upon completion of Session 12.
15842444|NCT04104009|Other|Education|"Following the randomization process, group education of pregnant women will be conducted through four one-hour meetings.
~Education program: teaching about the basics of childbirth physiology, visit to the maternity ward with the aim of reducing the fear of childbirth, applying the deep inhale and exhale exercise in the first birth stage, applying the classical music listening technique that will continue until the end of pregnancy daily (in the evenings before bedtime) (for 15 minutes), teaching and applying techniques for successful breastfeeding, maternal and infant health care after delivery. The training program will be implemented so that after 4 workshops a 5-week break will be taken. At the end of the program, the educator arranges with the respondents a weekly telephone check (for the sake of communication quality) to inform them of adherence to the agreed classical music listening.Pregnant women who do not meet expectations will be excluded from the study."
15842445|NCT04104009|Other|No education|In the control group there will be no education, no breathing exercises and no listening to classical music.
15842446|NCT04103996|Diagnostic Test|Ultrasound|Sonographic measurements (diaphragm, abdominal muscle, and quadriceps thickness) will be acquired when listed for lung transplantation. Sonographic measurements will be recorded on a daily basis for up to 1 week after transplantation (while the patient remains intubated).
15842558|NCT04102995|Drug|Placebo injection|Subcutaneous (SC) administration
15842447|NCT04103996|Diagnostic Test|Respiratory function measurements|Maximal expiratory pressure (MEP) and maximal inspiratory pressure (MIP) will be acquired after listing for lung transplantation. After transplant, MIP will be recorded once patients are eligible for a trial of spontaneous breathing and weekly thereafter. MEP will also be recorded at ICU discharge.
15842448|NCT04103983|Device|Sensory retraining device|Participants will be given a device to keep at home and will be asked to use it for 90 minutes each day, as one block, or as multiple shorter sessions of 10 minutes minimum duration. Participants will be asked to use their device on 15 of the 21 days. They will asked to spread out the use of the device over the 21 days. Participants are asked to record device use in a diary.
15842449|NCT04103970|Behavioral|Graded Activity and Pain Education (GAPE)|"GAPE is based on a cognitive behavioral perspective that human behavior is affected by behavioral, cognitive and affective factors, this include the patient's perception of and response to pain. The perspective is a psycho-social perspective which amplify and interact with the individual patient's pathology.
~The overall theoretical perspective in GAPE is that fear of movement and/or lack of self-efficacy for exercise can potentially lead to disuse and sedentary behavior, a perspective modified from the fear-avoidance model. In this modified version the patients´ and the physiotherapists´ former experiences, knowledge, and beliefs are factors influencing on the patients´ experience of pain and thereby their self-efficacy for exercise and fear of movement."
15842450|NCT04103944|Procedure|Core Decompression|10 patients will be randomized chosen in this group
15842451|NCT04103944|Procedure|Osteonecrotic Repair Device|10 patients will be randomized chosen in this group
15842452|NCT04103931|Behavioral|"Treatment Choices for Aortic Stenosis Decision Aid"|"A decision aid, titled Treatment Choices for Aortic Stenosis, produced by the American College of Cardiology that contains information for patients deciding between TAVR and surgery to treat their aortic stenosis."
15842453|NCT04103918|Device|Jalucomplex|Jalucomplex is an injectable intradermal gel containing sodium salts derived from hyaluronic acid.
15842454|NCT04103905|Drug|Recombinant Humanized Monoclonal Antibody MIL62 Injection|The patients confirming to the eligibility criteria will be assigned to the 5 dose groups (200mg, 400mg, 800mg, 1000mg, and 1500mg, respectively) based on the sequence of inclusion. Each patient received an intravenous infusion of MIL62 on Days 1, 8, and 15 of Cycle 1 and on Day 1 of Cycles 2-8 for a maximum of 8 cycles and 10 infusions. Each cycle was 21 days.
15842457|NCT04103879|Biological|ECT-001-CB (UM171-Expanded Cord Blood Transplant)|"Conditioning: High dose TBI (1320 cGy TBI + Fludarabine 75 mg/m2 + Cyclophosphamide 120 mg/kg) or Intermediate Intensity regimen (400 cGy TBI + Fludarabine 150 mg/m2 + Cyclophosphamide 50 mg/kg + Thiotepa 10 mg/kg).
~Single UM171-Expanded CB transplant (CD34+: 2.5-50x10E5/kg, CD3+>1x10E6/kg)
~Immunosuppression: Tacrolimus/MMF"
15842458|NCT04103866|Device|Juvederm Voluma|Juvederm will be used in various parts of the foot to increase collagen volume and decrease high pressures of stress typically seen as people age. It will serve to promote the following: foot cushioning due to tissue atrophy, increase comfort when walking, decrease gait peak pressures which will decrease stress on bones and soft tissue and heal calluses, skin lesions, etc. It will also decrease the patient need for balancing and offloading by the use of an in-shoe orthotic device that requires a closed shoe system. Many people complain of pain walking barefoot, in high heels and sandals where orthotics are not effective.
15842459|NCT04103853|Drug|Proxalutamide|Stage1:Dose esclation. Stage2:the expansion cohort where one or no DLT takes place in planned study cohort.
15842460|NCT04103840|Other|Testing stool mycobiota|Both cohorts of SAH and their family controls will be tested for fecal mycobiota
15842461|NCT04103827|Other|usability assessment|"Usability of Le Qoos will be assessed using a validated usability questionnaire"
15842462|NCT04103814|Drug|magnesium-cannabidiolic acid cream|Patients will receive Mg-CBDa (magnesium-cannabidiolic acid) cream for topical treatment of hallux rigidus or hallux valgus.
15842463|NCT04103814|Drug|Placebo cream|Patients will receive placebo cream (neutral emollient containing no active agent) for topical treatment of hallux rigidus or hallux valgus. The ingredients of the placebo cream are as follows: Butyrospermum parkii (shea butter), caprylic/capric triglycerides medium-chain triglycerides (MCT oil), food coloring to match the CBD oil. There will be 345 grams of shea butter and 62ml MCT oil per batch.
15842464|NCT04103801|Dietary Supplement|Sucrose|Participants in the intervention group were given 2 ml dose of 50% sucrose solution and participants in the placebo group were given 2 ml dose of sterile water. Both groups were administered slowly over 30 seconds sublingually via needle-less syringe immediately prior to the immunization injections.
15842465|NCT04103788|Dietary Supplement|95% Curcuminoid Powder|1200 mg curcuminoids
15842466|NCT04103788|Dietary Supplement|BIOCURC|400 mg curcuminoids
15842467|NCT04103775|Behavioral|Cognitive Remediation|See Cognitive Remediation Arm description.
15842468|NCT04103775|Behavioral|Active Control|See Active Control Arm description.
15842469|NCT04103762|Procedure|laparoscopic cholecystectomy|laparoscopic cholecystectomy
15842470|NCT04103762|Diagnostic Test|systematic intraoperative cholangiography|systematic intraoperative cholangiography in both groups (use of Indocyanine Green in ICG group and Iomeron in the CPO group)
15842471|NCT04103749|Device|Exalt Model D Single-Use Duodenoscope|Subjects will have a clinically indicated per standard of care ERCP or other duodenoscope-based procedure performed with the Exalt single use duodenoscope study device.
15842472|NCT04103736|Dietary Supplement|Beet It Sport Shot|Source of naturally occurring dietary nitrates
15842473|NCT04103736|Dietary Supplement|Nitrate-depleted placebo|Placebo
15842474|NCT04103723|Procedure|Preoperative premedication|Every patient with or without a preoperative premedication with midazolam before surgery.
15842475|NCT04103697|Drug|Capecitabine|2000 mg/m2, bid, per os, days 1-14, 4 cycles
15842476|NCT04103697|Drug|Oxaliplatin|130 mg/m2 iv day 1, 4 cycles
15842477|NCT04103697|Drug|Capecitabine|825 mg/m2, bid, per os, only on days of radiation (Monday through Friday)
15842478|NCT04103697|Radiation|Radiotherapy|Pelvic radiotherapy dose: 44 Gy on regional nodes, 50 Gy on primary tumor
15842479|NCT04103697|Procedure|Rectal cancer surgery|Laparoscopic or open partial or total mesorectal excision (based on exact tumor location and surgeons discretion)
15842480|NCT04103684|Drug|Methylprednisolone|30mg per kg per day for 5 days followed by course of oral prednisolone
15842482|NCT04103671|Procedure|Prompt panretinal photocoagulation|Study eyes that receive panretinal photocoagulation (prompt PRP eyes at baseline) should have 1200 to1600 burns with a spot size on the retina of approximately 500 microns given over 1 to 3 sittings and completed within 4 weeks of initiation
15842483|NCT04103671|Procedure|25G Pars-plana vitrectomy|Study eyes that receive standard 25G Pars-plana vitrectomy that remove all the vitreous, without laser or Silicone oil tamponade, but filled with perfusion fluid. Surgery should be completed within 4 weeks after randomization.
15842484|NCT04103658|Radiation|Near-infrared heating|Same as the arm/group description. The NIR heating group will have the non-melanoma skin cancer lesion excised based on the lesion borders established from application of NIR heat at a distance of 20cm for 10 minutes.
15842485|NCT04103645|Drug|Vactosertib|This drug is a TGF-Beta receptor type 1 inhibitor, by inhibiting phosphorylation of the ALK5 substrates SMAD2 and SMAD3. This inhibition could promote regeneration of normal human stem cells and proliferation of erythroid progenitors to treat the underlying hypoproliferative anemia in advanced MPNs.
15842486|NCT04103632|Diagnostic Test|EVH test|"Spirometry
~Skin prick test
~Peripheral blood test
~FeNO measurement"
15842487|NCT04103619|Device|AccuTite|Subjects will undergo treatment with AccuTite
15842488|NCT04103619|Device|AccuTite + Morpheus 8|Subjects will undergo treatment with AccuTite and Morpheus 8
15842489|NCT04103606|Device|GGBI: Positive Body Image (Mobile App)|Brief, game-like, training exercise for challenging body image disorder symptoms and associated psychological features
15842490|NCT04103593|Behavioral|exercise training|12-weeks of high-intensity functional circuit exercise that will be broadcasted from the Salem VAMC to older Veterans living with HIV in the Atlanta and Baltimore VAMCs
15842491|NCT04103580|Behavioral|Photo elicitation|Caregivers are taught to use photos to illustrate various feelings and meanings
15842492|NCT04103567|Other|Biological collection|Fecal samples collected at different times : during inclusion consultation with surgeon, after neoadjuvant treatment and before surgery.
15842493|NCT04103554|Drug|Sacubitril-Valsartan|Sacubitril-Valsartan 24/26 mg BID, 49/51 mg BID, 97/103 mg BID
15842494|NCT04103554|Drug|Standard of care|standard of care used for treating BP
15842495|NCT04103541|Behavioral|IP-Colombia|The IP-Colombia program is a multi-component intervention carried out in the context of therapeutic camp, based on EDMR therapies and mindfulness-based interventions. Alongside the interventions, activities are done to facilitate healthy lifestyles, empathy, [and] the recognition and expression of emotions through exercise, art workshops, musical creation, dance and theater.
15842496|NCT04103528|Other|morning surgery|31 patients will be operated on between 8:00 and 12:00 in the morning.
15842497|NCT04103528|Other|afternoon surgery|31 patients will be operated on between 14:00 and 18:00 in the afternoon.
15842498|NCT04103515|Device|Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty|Zimmer-Biomet Posterior Cruciate Retaining total knee arthroplasty
15842499|NCT04103515|Device|Zimmer-Biomet Posterior Stabilizing total knee arthroplasty|Zimmer-Biomet Posterior Stabilizing total knee arthroplasty
15842500|NCT04103502|Device|MicroPort Medial Pivot TKA|Subjects will have been implanted with the MicroPort Medial Pivot TKA
15842501|NCT04103502|Device|DePuy Attune PCR TKA|Subjects will have been implanted with the DePuy Attune PCR TKA
15842502|NCT04103489|Drug|Eculizumab|Participants will receive eculizumab at diagnosis of HELLP syndrome. Participants will receive a maximum of 4 doses.
15842503|NCT04103476|Combination Product|Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg|Oral bazedoxifene 20 mg / conjugated estrogens 0.45 mg
15842504|NCT04103476|Other|Placebo|Placebo
15842505|NCT04103463|Other|Interactive stepping exercise|An exercise intervention based on the principle of square stepping exercise
15842506|NCT04103463|Other|Home exercise|Home exercise
15842507|NCT04103450|Drug|Vibegron|oral administration
15842508|NCT04103437|Diagnostic Test|Maximal incremental running test|"Maximal incremental running test with measures of metabolic, spatio-temporal parameters and video recording with camera in the frontal plane.
~video recording of frontal view, metabolic and spatio-temporal measures of three (self-selected speed, + and - 20 percentage of self-selected speed) 6 minutes running test monthly (12 months) follow-up questionnaire"
15842509|NCT04103437|Diagnostic Test|Metabolic and movement analysis of running|Running analysis of three six minutes running test (self-selected speed, + and - 20% of the self-selected speed) by video recording with camera in the frontal plane, and acquisition of the metabolic and spatio-temporal parameters
15842510|NCT04103437|Other|Questionnaires|Monthly follow-up questionnaire (12 months) about training habits and injuries
15842511|NCT04103424|Behavioral|Short-term Exercise Training|Participants will perform 2-weeks of supervised exercise training on a stationary bike.
15842512|NCT04103411|Other|24h-Ambulatory Blood Pressure|Effect of High Intensity Interval Training compared to Hydrochlorothiazide on ambulatory Blood Pressure.
15842513|NCT04103398|Combination Product|TACE+sorafenib|The initial dose of sorafenib is 400mg BID and the drug therapy will last till outcome events happen or the trial ends. TACE will start one day following oral sorafenib. Either conventional TACE (cTACE) or drug-eluting beads TACE (dTACE) is optional. TACE will be performed via injecting chemotherapy drugs (oxaliplatin 200mg, raltitrexed 4mg, epirubicin 20mg in cTACE or 70mg in dTACE) and embolizing agents (gelatin sponge or microsphere) into blood vessels that help tumor grow.
15842514|NCT04103398|Procedure|TACE|Either conventional TACE (cTACE) or drug-eluting beads TACE (dTACE) is optional. TACE will be performed via injecting chemotherapy drugs (oxaliplatin 200mg, raltitrexed 4mg, epirubicin 20mg in cTACE or 70mg in dTACE) and embolizing agents (gelatin sponge or microsphere) into blood vessels that help tumor grow.
15842515|NCT04103385|Behavioral|RISE (Reconnecting to Internal Sensations and Experiences)|The overarching goal of RISE is to increase interoception by reconnecting people with their internal sensations
15842516|NCT04103385|Behavioral|RISE (Reconnecting to Individual Strength and Energy)|Aims to reduce life stressors and improve physical health
15842517|NCT04103372|Other|Surveillance 6 monthly|6 monthly surveillance
15842518|NCT04103372|Other|Radiotherapy and surveillance|as per local policy
15842519|NCT04103372|Other|surveillance 3 montly|3 monthly surveillance
15842520|NCT04103359|Other|Physiological tests to measure fatigue level|Physiological tests to measure fatigue level
15842556|NCT04102995|Drug|Sepranolone injection low dose|Subcutaneous (SC) administration
15842521|NCT04103346|Other|air filtration with air purifier with hepa filter|long-term (4 week) air filtration with the Holmes HAP8650B-NU-1 air purifier in the residence of low-income seniors impacted by roadway pollutants.
15842522|NCT04103346|Other|sham|air purifier running with air filter removed
15842523|NCT04103333|Procedure|Lumbar Puncture|Administered as specified in the treatment arm.
15842524|NCT04103333|Procedure|Blood Collection|Administered as specified in the treatment arm.
15842525|NCT04103320|Other|Using different survey to evaluate pain|Survey will be at different time of the IVF protocol (at the first medical appointment in the medically assisted department, after stimulation, after oocytes retrieval, after embryo transfer, one month after the IVF protocol)
15842526|NCT04103307|Procedure|Dialysis cooling|Cooling the blood in the CRRT circuit during delivery
15842527|NCT04103294|Dietary Supplement|cowpea variety #1|two most popular varieties of cowpea currently consumed in the selected geographic area
15842528|NCT04103294|Dietary Supplement|cowpea variety #2|two most popular varieties of cowpea currently consumed in the selected geographic area
15842529|NCT04103281|Other|Sepsis|Sepsis patients in the ICU with a breathing tube
15842530|NCT04103268|Other|sepsis|patients in the ICU with infection called sepsis
15842531|NCT04103255|Other|High frequency and intensive prevention program|This study is a 4 week randomized controlled trial (RCT)
15842532|NCT04103242|Other|16s rRNA gene sequencing|High-throughput sequencing of the microbial 16s rRNA subunit to define the abundance of microbial phyla and genera
15842533|NCT04103229|Procedure|The use of different types and volumes of solutions to inflate the catheter balloon|In catheterization procedure, catheter balloon was inflated according to the type and amount of fluid appropriate to the group to which the patient was assigned.
15842534|NCT04103216|Other|Nitazoxanide with Lactobacillus Reuteri DSM 17938|Nitazoxanide with probiotics
15842535|NCT04103216|Other|Nitazoxanide|Nitazoxanide with placebo
15842536|NCT04103203|Diagnostic Test|PathoRobot/ Patho-Doc Test result|Test results of the new diagnostics will be available to the treating physician.
15842537|NCT04103190|Device|cerebral MRI|"Patients who agree to participate in the study will perform a 3T multi-parametric MRI with advanced spectroscopic imaging techniques and standard protocol.
~A neurological consultation will take place during the inclusion visit as well as a questionnaire and a control MRI at 1 year and 2 years +/- 1 month."
15842538|NCT04103177|Other|Chair based exercises in the dialysis environment|"Each participant will be given an educational / information booklet. It will include when the right time to engage in Physical Activity. The Chair-based Exercise Program will be the focus of the exercise intervention with written step- by-step instructions with demonstrative image of the exercises. Further details included in this booklet will include, information regarding the benefits of exercise including walking and safety measures in undertaking the exercises.
~Sports Exercise Instructor led Chair-based Exercise Programme Patients will be given Sports Exercise Instructor led training on how to perform the chair-based exercises, for 6 weeks. This will be delivered during one of the patients' dialysis sessions. The Instructor will deliver a short 10 minute session to patients and deliver safety instruction.
~Motivational interviewing Motivational interviewing will consist of discussion to encourage the participant without coercion and help them develop goals."
15842539|NCT04103164|Device|Cutera excel V™ Laser|The Cutera® excel V laser is manufactured by Cutera, Inc. This laser with 532 nm KTP and 1064 nm Nd:YAG wavelengths has received 510(k) clearance by the U.S. Food and Drug Administration (FDA) to market the device for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue 510(k) number 022226. The 532 nm wavelength is indicated for the coagulation and hemostasis of benign vascular and cutaneous lesions in dermatology including, but not limited to, benign vascular lesions like angiomas, hemangiomas, port wine stains, venous anomalies and telangiectasia; benign pigmented lesions like nevi, lentigines, chloasma, café-au-lait; verrucae; skin tags; keratoses; plaques. The Cutera® excel V laser has also obtained the European CE Mark. The system was tested to ensure compliance with federal laser performance standards as applicable.
15842540|NCT04103151|Device|Single lead ECG|Heart Rate Variability will be monitored using a single lead electrocardiogram
15842541|NCT04103138|Device|Sedline EEG sensor placement|Patients will have Sedline EEG sensor placed before or immediately after induction.
15842542|NCT04103138|Device|Sedline EEG monitoring|Anaesthesia depth will be guided by EEG characteristics in addition to routine clinical parameters
15842543|NCT04103125|Device|Janesse® is a sterile, injectable, non-pyrogenic, re-absorbable medical product made of reticulated hyaluronic acid of non-animal origin, produced via bacterial fermentation.|The subjects will receive at baseline the first IMD by the Investigator in accordance with the CIP
15842544|NCT04103112|Device|Graduated compression stocking|"Compression stockings have been used safely in the UK for about 50 years. They contain an elastic fibre designed to fit tightly around the legs. These specialist stockings are tighter around the ankle, with the level of compression gradually decreasing up the garment.
~The pressure created by the stockings helps blood flow up the leg, allowing blood to flow freely to the heart and not pool in the leg which can result in pain and swelling."
15842545|NCT04103099|Dietary Supplement|HLNatural Immune|Vitamin C, Echinacea, Ivy Extract, Zinc, Ginger and Turmeric in a powder form mixed with water
15842546|NCT04103086|Drug|Aromatherapy|"Free aromatherapy (70% menthol and 30% propanediol) will be provided for 6 months. All participants will receive the standard inhalation method training before hospital discharge.
~The aromatherapy will be given twice daily, one treatment in the morning and one in the evening. At each treatment, 4 deep steady inhalations will be performed, and 10 seconds per inhalation is optimal."
15842547|NCT04103086|Drug|Placebo|Free placebo (10% menthol and 90% propanediol) will be provided for 6 months. The specific method is the same as aromatherapy
15842548|NCT04103060|Drug|Cerdulatinib 0.37% gel|Cerdulatinib 0.37% gel applied topically twice daily for 6 weeks
15842549|NCT04103060|Drug|Vehicle gel|Vehicle gel applied topically twice daily for 6 weeks
15842550|NCT04103047|Other|SAD|The patients who have an SAD inserted as part of their normal Anaesthetic plan will be consented prior to their Anaesthetic and then have a questionnaire to fill out post operatively.
15842551|NCT04103034|Drug|BT200|BT200 is a PEGylated synthetic RNA oligonucleotide
15842552|NCT04103034|Drug|Desmopressin|Sterile solution for injection
15842553|NCT04103034|Drug|Placebo|Sterile saline for injection
15842559|NCT04102982|Drug|Camrelizumab|Patients will be treated with camrelizumab alone.
15842560|NCT04102982|Other|Camrelizumab plus microwave ablation|In the group, microwave ablation will be administrated to the primary tumors, followed by camrelizumab.
15842561|NCT04102969|Behavioral|Benson Relaxation Technique|Benson relaxation technique will be performed two times a day for 10 minutes during the study period ( two months) for the intervention group.
15842562|NCT04102969|Other|Nutrition Package Session|A nutrition package session will be given to the control group.
15842563|NCT04102956|Drug|Kallikrein|HUK has been approved by China's State Food and Drug Administration as a state category I new drug for the treatment of stroke patients. Based on the available evidence, HUK injection ameliorates neurological deficits and improves long-term outcomes.
15842564|NCT04102943|Drug|tacrolimus tablet|"Orally, twice a day in the morning and night
~After first dose 0.1mg/kg, check the blood concentration of tacrolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 7~12ng/ml for 0 to 3months and then at 5~8ng/ml for 3 to 6months of study treatment."
15842565|NCT04102943|Drug|tacrolimus capsules|"Orally, twice a day in the morning and night
~After first dose 0.1mg/kg, check the blood concentration of tacrolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 7~12ng/ml for 0 to 3months and then at 5~8ng/ml for 3 to 6months of study treatment."
15842566|NCT04102917|Diagnostic Test|QFR assessment|The quantitative flow ratio (QFR) is a novel angiography-based method for noninvasive functional assessment of intermediate coronary lesions.
15842567|NCT04102904|Other|Observational|Patients will be asked to donate a semen sample which will be analysed and compared with their eventual diagnosis.
15842568|NCT04102891|Other|Microbiota modulation diet|The Collect&Go shopping carts of the 400 participants will be adapted by replacing food products by healthier alternative ones based on the Flemish food-based dietary guidelines and the microbiota modulation diet guidelines for the control and study arm respectively. Based on these guidelines, and the habitual dietary pattern and level of food literacy of the participant, personalized dietary advice will be provided. A dietitian helpline will be available for further nutritional issues as well.
15842569|NCT04102878|Drug|Topical Anesthetic|Topical anaesthetic drops (proxymetacaine 0.5% and tetracaine 1%) applied
15842570|NCT04102878|Procedure|Transconjunctival anaesthetic|Local anaesthetic (50/50 mixture of bupivacaine 0.5% / lidocaine 2% with adrenaline 1:200 000) administered to the eyelid via the transconjunctival route
15842571|NCT04102878|Procedure|Transcutaneous anaesthetic|Local anaesthetic (50/50 mixture of bupivacaine 0.5% / lidocaine 2% with adrenaline 1:200 000) administered to the eyelid via the transcutaneous route
15842572|NCT04102878|Other|Patient comfort questionnaire|The patient will be asked to rate the level of pain during each local anaesthetic injection on a 0-10 scale
15842573|NCT04102878|Other|Facial photograph|The patient will have a photograph taken following the anaesthetic injections to document the presence or absence of bruising
15842574|NCT04102878|Procedure|Eyelid surgery|Eyelid surgery will be performed as per the plan from their preoperative appointment
15842575|NCT04102865|Device|Negative Pressure Wound Therapy|Single use disposable negative pressure system. The system is capable of delivering up to 80 mm Hg negative pressure to a wound or surgical incision site and managing low to moderate levels of exudate or fluid generated by the wound or incision. The therapy may be administered for up to 1 week.
15842576|NCT04102852|Dietary Supplement|Lactobacillus rhamnosus GG ATCC 53103|probiotic administration at two different doses for 1 month
15842577|NCT04102839|Other|Interview|Qualitative Interview
15842578|NCT04102826|Device|Functional electrical stimulation (FES)|Functional electrical stimulation combined with mobile arm support to restore upper limb function.
15842580|NCT04102800|Drug|Benralizumab|subcutaneous injection
15842581|NCT04102787|Other|cardiac educational program|"Love your Heart is a Heart Foundation program (2016), the Arabic version will be used as the educational program in this study. The programme has been adopted from relevant articles in the evidence- based literature. The program is a guide to support recovery and good heart health. It includes the following: anatomy and physiology of the heart, causes, symptoms and risk factors of CAD, healthy diet, physical activity, weight management, and risk factors management."
15842582|NCT04102774|Device|Over-night treatment with myAIRVO2|"Gas flow will be set between 20 and 30 l/min, according to patient's comfort, and administrated via nasal canula.
~Temperature will be set at 37°C. If the patient was already in nocturnal oxygen therapy FiO2 will be set according to the prescription."
15842583|NCT04102761|Procedure|Intradiscal PRP & BMC Injections|The intervention to be studied is the intradiscal delivery of autologous Platelet Rich Plasma (PRP) or bone marrow concentrate (BMC) into the nucleus pulposus of the disrupted disc(s).
15842584|NCT04102748|Procedure|I-incision, M-flap and conventional implant exposure techniques|Implant uncovering in the second stage using 3 different exposure techniques
15842585|NCT04102735|Device|Under-the-nose facemask|Patients with acute hypercapnic respiratory failure that need noninvasive ventilation and are randomized in the experimental group will receive the AF541 facemask used with the under-the-nose cushion.
15842586|NCT04102735|Device|Over-the-nose facemask|Patients with acute hypercapnic respiratory failure that need non-invasive ventilation and are randomized in the comparator group will receive the AF541 facemask used with the over-the-nose cushion.
15842587|NCT04102722|Device|MUST device|Imaging with MUST device
15842588|NCT04102709|Device|Health Tag|Health Monitoring Device
15842589|NCT04102696|Drug|Aromatherapy|"Free aromatherapy (70% menthol and 30% propanediol) will be provided for 6 months. All participants will receive the standard inhalation method training before hospital discharge.
~The aromatherapy will be given twice daily, one treatment in the morning and one in the evening. At each treatment, 4 deep steady inhalations will be performed, and 10 seconds per inhalation is optimal."
15842590|NCT04102696|Drug|Placebo|Free placebo (10% menthol and 90% propanediol) will be provided for 6 months. The specific method is the same as aromatherapy.
15843345|NCT04096313|Diagnostic Test|HbA1c, Lipids, UACr|compare diagnostic tests to reference methods
15842591|NCT04102683|Behavioral|Therapeutic recreation activity program|The experimental recreation program, which consisted of two sessions per week and lasted approximately 1 hour each session, lasted for 8 weeks between March 2019 and May 2019 for the adolescents in the experimental group. The Therapeutic Recreation Activity Program, which consists of 16 sessions, is organized according to the self-determination and entertainment development model. This model aims to provide individual development and prosperity by creating an entertaining environment with therapeutic recreation. According to the degree of enjoyment, activity improves freedom of choice, preferences and ability to express oneself. Pleasure is a feeling that the participant feels deeply during therapeutic recreation. Provides entertainment experience. Pleasure increases individual motivation to participate, as well as making the best use of physical, social and emotional conditions.
15842592|NCT04102670|Device|Ultherapy|Subjects will be treated with Ultherapy, which is a microfocused ultrasound, on the lower face, neck, and chest.
15842593|NCT04102670|Device|Xeomin|Vertical neckbands, also known as platysma bands, will be injected with Xeomin to relax the bands.
15842594|NCT04102670|Device|Belotero Balance|Horizontal necklace lines will be filled using Beletero Balance.
15842595|NCT04102670|Device|Dilute Radiesse|The chest area will be injected with dilute Radiesse to stimulate collagen.
15842596|NCT04102670|Other|Neocutis Micro Firm Face and Neck Cream|Neocutis Micro Firm Face and Neck Cream will be provided to subjects for topical use at home.
15842597|NCT04102657|Other|Intermittent Fasting|Participants will be instructed to limit their daily food consumption to an 8-hour period in the day of their choosing. For the 16-hour fasting period, subjects are to eliminate caloric intake.
15842598|NCT04102657|Other|Free-Living Diet|Participants will maintain their current daily food consumption with no caloric restriction. Patient must not have participated in a specialized diet or weight loss program within 2 weeks of enrollment.
15842599|NCT04102657|Other|Left Arm Exercise|Participants will complete a 20-minute period of rest followed by a 20-minute unilateral arm exercise on the left arm. In the middle of the study, participants will switch to the right arm to complete their unilateral arm exercises.
15842600|NCT04102657|Other|Right Arm Exercise|Participants will complete a 20-minute period of rest followed by a 20-minute unilateral arm exercise on the right arm. In the middle of the study, participants will switch to the left arm to complete their unilateral arm exercises.
15842601|NCT04102644|Other|Observation|Documentation of course and outcome of hospitalization, labor, delivery, and postpartum period
15842602|NCT04102631|Diagnostic Test|colonoscopy with assistance of Endo.Angel|Patients in exposed group will receive colonoscopy with assistance of Endo.Angel,a real-time quality monitoring system based on computer vision,which is used to monitor the velocity of insertion of the endoscope, record the time of insertion and withdrawal of the endoscope, and remind endoscopists of the blind areas caused by intestinal segment slipping.
15842603|NCT04102631|Diagnostic Test|colonoscopy without assistance of Endo.Angel|Patients in non-exposed group will receive colonoscopy without assistance of Endo.Angel.
15842604|NCT04102618|Biological|Pelareorep|4.5 × 10e10 TCID50 administered intravenously on Days 1, 2, 8 & 9
15842605|NCT04102618|Drug|Letrozole|Oral dose of 2.5 mg/day starting on Day 3 for 13 days
15842606|NCT04102618|Drug|Atezolizumab|1200 mg administered intravenously on Day 3
15842607|NCT04102618|Drug|Trastuzumab|8mg/kg administered intravenously or 600mg subcutaneously on Day 3
15842608|NCT04102605|Device|Nunap Vision|Participants receive visual perceptual training using the Nunap Vision software
15842609|NCT04102605|Device|Nunap Vision-C|Participants receive sham training using the Nunap Vision-C software
15842610|NCT04102592|Other|Permethrin-treated Lesu (baby wrap)|0.5% permethrin application
15842611|NCT04102592|Other|Untreated Lesu (baby wrap)|Matching untreated lesu
15842612|NCT04102579|Drug|Valbenazine|vesicular monoamine transporter 2 (VMAT2) inhibitor
15842613|NCT04102579|Drug|Placebo|non-active dosage form
15842614|NCT04102566|Drug|Ibuprofen 600 mg|We'll be adding ibuprofen while trying to limit oxycodone use while hospitalized. Patients will not be discharged with a narcotic.
15842615|NCT04102566|Behavioral|Education|We'll be adding education to patient's post-operative instructions to aid in their pain control management.
15842616|NCT04102553|Drug|F-18-PSMA-1007|Patients will receive F-18-PSMA-1007 PET/CT and F-18-Fluorocholine PET/CT in randomized order.
15842617|NCT04102553|Drug|F-18-Fluorocholine|Patients will receive F-18-PSMA-1007 PET/CT and F-18-Fluorocholine PET/CT in randomized order.
15842618|NCT04102540|Other|Infographic intervention|Information visualizations (infographics) will be used to teach participants about HIV during study visits immediately following their normal clinic visits.
15842619|NCT04102527|Other|Questionnaires|"Patients have to complete the study questionnaires every 2 months :
~Digestive Functional Score of Neurological Patients
~Bowel Function Index
~Severity score for constipation
~Bristol Scale
~Constipation assessment scale
~Estimate scale of risk of constipation"
15842620|NCT04102514|Behavioral|Real-time Group Video|Dyads in the RGV arm will be asked to complete three 45 min sessions that include aerobic, resistance, and balance/coordination exercises delivered by a trained health coach via Zoom® software on an iPad during mos. 0-6, and 1 session/wk. during mos. 7-12 to groups of 5-8 dyads in their home along with being provided written materials regarding exercise and physical activity from the National Institute on Aging and brief (15-20 min) FaceTime meetings (0-6 mos.= 2/mo.; 7-12 mos.= 1/mo.) with the heath coach to discuss progress, provide support and receive additional guidance on how to increase MPA.
15842621|NCT04102514|Behavioral|Enhanced Usual Care|Dyads in the EUC arm, will be given a recommended exercise plan to follow on their own along with being provided written materials regarding exercise and physical activity from the National Institute on Aging and brief (15-20 min) FaceTime meetings (0-6 mos.= 2/mo.; 7-12 mos.= 1/mo.) with the heath coach to discuss progress, provide support and receive additional guidance on how to increase MPA.
15842622|NCT04102501|Drug|RT001|RT001 is encapsulated 9-cis, 12-cis-11,11-D2-linoleic acid ethyl ester, which is a site specific (C11) di-deutero synthetic homologue of LA ethyl ester. Each capsule contains 960 mg of RT001.
15842623|NCT04102501|Drug|Placebo|The placebo product is composed of encapsulated USP safflower oil. The placebo capsules are identical in appearance and size to RT001.
15842624|NCT04102488|Procedure|Six-step hand hygiene technique with an application time of 30 seconds|Six-step hand hygiene technique with an application time of 30 seconds
15842625|NCT04102488|Procedure|Six-step hand hygiene technique with an application time of 15 seconds|Six-step hand hygiene technique with an application time of 15 seconds
15842626|NCT04102488|Procedure|Three-step hand hygiene technique with an application time of 30 seconds|Three-step hand hygiene technique with an application time of 30 seconds
15842627|NCT04102488|Procedure|Three-step hand hygiene technique with an application time of 15 seconds|Three-step hand hygiene technique with an application time of 15 seconds
15842628|NCT04102475|Other|Eatline|"After discharge from a first hospitalization:
~Phone calls at 15 days, 1, 2, 4 and 9 months by a trained psychologist. The phone interview will be guided by the same standardized frame, which was developed by a group of experts and tested with a group of patients. The purpose of this intervention is to provide a therapeutic and motivational approach, with positive reinforcement and reassurance.
~Added to treatment as usual (TAU): outpatient visits (at least monthly consultations) or scheduled hospitalizations
~6- and 12-month assessments as an outpatient interview with an assessor who is blind to condition"
15842629|NCT04102475|Other|Control|"After discharge from the first hospitalization:
~No specific phone calls
~TAU: outpatient visits (at least monthly consultations) or scheduled hospitalizations
~6- and 12-month assessments as an outpatient interview with an assessor who is blind to condition"
15842630|NCT04102462|Drug|BI 764198|Capsules
15842631|NCT04102462|Drug|Matching placebo|Capsules
15842632|NCT04102449|Drug|Apremilast|Single arm receiving Apremilast and ultrasound examinations
15842637|NCT04102410|Other|Sprints|"Two sprints of 8 seconds on a cycle ergometer will be performed for determine Force/Velocity Profile (FVP).
~Realized at inclusion and 2 months after."
15842638|NCT04102410|Other|Vertical jumps|"Two vertical jumps will be performed. Height of theses vertical jumps will be measured by application My jump 2 to determine muscle power.
~Realized at inclusion and 2 months after."
15842639|NCT04102410|Other|Questionary Short Form-12 (SF-12)|"Questionary Short Form-12 (SF-12) will be performed to evaluate quality of life. It is composed of 12 questions.
~Realized at inclusion and 2 months after."
15842640|NCT04102410|Device|activity actigraph|"Activity actigraph will be wearing by patient during 7 consecutive days. It measures the level of physical activity and the sedentary lifestyle of patients.
~Realized at inclusion and 2 months after."
15842641|NCT04102410|Other|Program composed of two 2 training strategies|"Program composed of two 2 training strategies according to the initial Force/Velocity Profile (FVP) will be realized at the inclusion.
~There are :
~Strategy experimental-speed: speed training strategy for subjects with a force-speed profile (PFV) in favour of force
~Strategy experimental-force: force training strategy for subjects with a force-speed profile (PFV) in favour of speed."
15842642|NCT04102410|Other|Program of usual practice|Program composed of training in force and speed independently of the initial Force/Velocity Profile (FVP).
15842643|NCT04102397|Procedure|Vojta therapy after standard therapy|Vojta Therapy ~20 minutes/session: Application of the Reflex Creeping complex, activating several stimulus points on the facial and the nuchal sides (Figure 3a), and then the activation of the Reflex Rolling complex in both the supine position and with the patient lying on his or her side, alternating between nuchal and facial stimulation and guiding from the head.
15842644|NCT04102397|Procedure|Standard therapy|"~50 minutes/session:
~TENS Current (20 minutes, phase duration=0.10 microseconds, frequency=50 Hz). The intensity applied depended on the patient's tolerance for the treatment (Figure 2a).
~Pulsating ultrasound (5 minutes around the shoulder, frequency=1MHz, intensity=1 W/cm2) (Figure 2b).
~Kinesiotherapy. In stages: at first assisted (with isometric exercises), then free, and finally, with resistance, usually with elastic bands (Figure 2c).
~Cryotherapy (5 minutes)."
15842645|NCT04102384|Other|e-PRO App|The e-PRO app is designed to further facilitate the delivery of PRO instruments in a convenient manner to participants. Through its computing capability, and user-friendly interface, the e-PRO app can collect data and implement complex scoring requirements, thus supporting the delivery of self-administered survey questionnaires.
15842646|NCT04102371|Drug|Lactated Ringer|"LR is a sterile, nonpyrogenic balanced solution used for fluid and electrolyte replenishment via intravenous or intraosseous administration. Each 100 mL of LR contains 600 mg sodium chloride (NaCl), 310 mg of sodium lactate (C3H5NaO3), 30 mg of potassium chloride (KCl), and 20 mg of calcium chloride (CaCl2 · 2H20) with an approximate potential of hydrogen (pH) of 6.5 (6.0 to 7.5)."
15842647|NCT04102371|Drug|Normal Saline|"Normal saline solution is an unbalanced crystalloid solution containing 154 mEq/L of sodium and 154 milliequivalent (mEq/L) of chloride."
15842648|NCT04102371|Drug|Plasma-lyte|PL is a sterile, nonpyrogenic isotonic solution in a single dose container for intravenous administration. Each 100 mL contains 526 mg of Sodium Chloride, USP (NaCl); 502 mg of Sodium Gluconate (C6H11NaO7); 368 mg of Sodium Acetate Trihydrate, USP (C2H3NaO2•3H2O); 37 mg of Potassium Chloride, USP (KCl); and 30 mg of Magnesium Chloride, USP (MgCl2•6H2O). It contains no antimicrobial agents. The pH is adjusted with sodium hydroxide. The pH is 7.4 (6.5 to 8.0).
15842649|NCT04102358|Procedure|Medial approach infraclavicular block with single injection|infraclavicular blocks performed with single injection
15842650|NCT04102358|Procedure|Medial approach infraclavicular block with triple injection|infraclavicular blocks performed with triple injection
15842651|NCT04102345|Other|Lavender Aromatherapy|Commercially available lavender essential oil and diffuser.
15842652|NCT04102345|Drug|Zolpidem|Physician directed, pre-prescribed. Study team does not prescribe zolpidem.
15842653|NCT04102332|Device|Safe Infusion Device|Safe infusion device is a different method than usual infusion practices (neutral solvent-purged infusers)
15842654|NCT04102319|Diagnostic Test|serum hepcidin|it is a serum marker
15842655|NCT04102306|Other|reliability and validity construct of the TMIQ|comparison of the TMIQ to the gold-standard questionnaire (KVIQ) and test-retest
15842656|NCT04102293|Procedure|NSK Endo motor Endomate|Rotary instrumenation used in pulp therapy
15842657|NCT04102293|Procedure|manual K-files|manual instrumentation used in pulp therapy
15842658|NCT04102280|Device|Dialyser|Three consecutive treatment weeks and one follow-up week per patient. Each treatment week includes three hemodiafiltration HDF sessions and is assigned to one type of dialyzer: FX P600 Fresenius Medical Care, comparator Xevonta Hi 15 (B. Braun) and comparator Elisio 150H (Nipro)
15842659|NCT04102267|Drug|Bupivacaine liposome injectable suspension|Liposomal bupivacaine 266 mg via injection
15842660|NCT04102267|Drug|Bupivacaine HCl without epinephrine via continuous infusion|Bupivacaine HCl 300 mg via continuous infusion
15842661|NCT04102254|Procedure|ANT recording and stimulation|In this study, the investigator aims to perform sEEG recordings during simultaneous ANT recording and stimulation to better understand the following: 1) how the ANT is involved in various seizure types; 2) which cortical regions are modulated by established ANT stimulation patterns; and 3) how novel ANT stimulation patterns modify epileptogenic cortical activity.
15842662|NCT04102241|Drug|15mg Hemay005|Hemay005 is a small molecule PDE4 inhibitor.
15842663|NCT04102241|Drug|Placebos|Placebos are the same as drugs, but contain no Hemay005.
15842664|NCT04102228|Device|1Hz inhibitory rTMS|20 minutes of 1Hz (1200 pulses) repetitive transcranial magnetic stimulation (rTMS) applied by Magstim Rapid 2 stimulator equipped with an airfilm figure-8 coil
15842665|NCT04102228|Device|1Hz sham rTMS|20 minutes of 1Hz (1200 pulses) repetitive transcranial magnetic stimulation (rTMS) applied by Magstim Rapid 2 stimulator equipped with an airfilm figure-8 sham coil.
15842666|NCT04102228|Behavioral|Multi-Modality Aphasia Therapy (M-MAT)|Participants receive 3.5 hours of intensive speech therapy in small groups delivered by a blinded speech language pathologist and therapy assistant. The objective of M-MAT is to improve word production through shaping of responses (ie. Gradually increasing complexity of spoken targets towards eventual mastery) and social-mediated repetitive practice. Therapists use game-based interactive tasks and rich multi-modal cueing (gestures, written words, drawing, reading words) to improve spoken production and oral communication.
15842667|NCT04102215|Device|HEARO|Robotic system for otological procedures
15842668|NCT04102215|Device|OTOPLAN|Otological surgical planning software
15842669|NCT04102202|Drug|BOL-DP-o-05|BOL-DP-o-05
15842670|NCT04102202|Drug|Placebo|Placebo
15842673|NCT04102176|Other|stopping nucleos(t)ide therapy|patients taking nucleoside(t)ide therapy will stop treatment
15842674|NCT04102176|Other|Continue nucleos(t)ide analogue|Continue nucleos(t)ide analogue
15842675|NCT04102150|Drug|Valemetostat Tosylate|Once a day, 200 mg, oral administration
15842676|NCT04102137|Biological|Pertagen (aP BioNet)|"Pertagen (aP BioNet) was produced with a recombinant B pertussis strain that was genetically inactivated by the introduction of mutations (Arg9Lys and Glu129Gly) in the ptx operon of the S1 gene. Each 0.5 mL dose of Pertagen (aP BioNet) contained 5 µg PTgen, 5 µg FHA, and 0.3 mg as aluminium cation.
~The study vaccine will be presented in a single-dose prefilled syringe. Each subject will be received one intramuscular injection in the non-dominant deltoid region."
15842677|NCT04102137|Biological|Boostagen (TDaP BioNet)|"Boostagen (TDaP BioNet) was produced with a recombinant B pertussis strain that was genetically inactivated by the introduction of mutations (Arg9Lys and Glu129Gly) in the ptx operon of the S1 gene. Each 0.5 mL dose of Boostagen (TDaP BioNet) contained 5 µg PTgen, 5 µg FHA, and 0.3 mg as aluminium cation. TDaP dose additional contained at least 7.5 Lf tetanus toxoid and at least 2.0 Lf diphtheria toxoid.
~The study vaccine will be presented in a single-dose prefilled syringe. Each subject will be received one intramuscular injection in the non-dominant deltoid region."
15842678|NCT04102137|Biological|Adacel|"Comparator vaccine, Adacel (Sanofi-Pasteur, North York, ON, Canada) was produced chemically inactivated pertussis toxin. Each 0.5 mL dose of Adacel (as comparator vaccine) contained 2.5 µg PTchem, 5 µg FHA, 3 µg pertactin, 5 µg fimbriae types 2 and 3, 5.0 Lf tetanus toxoid, 2.0 Lf diphtheria toxoid and 0.33 mg as aluminium cation.
~The study vaccine will be presented in a single-dose prefilled syringe. Each subject will be received one intramuscular injection in the non-dominant deltoid region."
15842679|NCT04102124|Drug|SHR3680|Tablet. Specifications of 80mg
15842680|NCT04102124|Drug|SHR3162|Tablet. Specifications of 10mg、40mg、50mg and 100mg
15842681|NCT04102124|Drug|SHR3680(Placebo)|Tablet. Specifications of 80mg
15842682|NCT04102124|Drug|SHR3162(Placebo)|Tablet. Specifications of 10mg、40mg、50mg and 100mg
15842687|NCT04102085|Other|no intervention|no intervention
15842688|NCT04102072|Diagnostic Test|Trendelenburg Maneuver|In the Trendelenburg position, the body is laid supine with the feet higher than the head by 15-30 degrees. The venous return increases in the trendelenburg position which in turn increases the stroke volume.
15842689|NCT04102072|Diagnostic Test|dobutamine stress test|Dobutamine was infused intravenously at the initial dose of 2.5 ug/kg/min. Echocardiography was performed after 5-10 minutes of continuous infusion, and hemodynamic data were recorded.
15842690|NCT04102033|Drug|Eltrombopag|Thrombopietic agent approved for its efficacy in chronic immune thrombocytopenia in pediatric patients
15842691|NCT04102020|Drug|Venetoclax|Tablet: Oral
15842692|NCT04102020|Drug|Azacitidine|Subcutaneous (SC) or intravenous (IV) injection
15842693|NCT04102020|Drug|Placebo for Venetoclax|Tablet; Oral
15842694|NCT04102020|Drug|CC-486|Tablet; Oral
15842695|NCT04102007|Drug|Risankizumab|Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS).
15842696|NCT04101994|Device|Virtual cycling training|Virtual cycling training is a convenient and easy approach for muscle strengthening.
15842697|NCT04101994|Device|Repetitive transcranial magnetic stimulation|Intermittent theta burst stimulation produces short TBS trains intermittently to facilitate cortical excitability.
15842698|NCT04101994|Device|Transcranial electric stimulation|TES is a constant current with low intensity delivered to the skull through surface electrodes.
15842699|NCT04101981|Procedure|oocytes retrieval|The oocytes retrieval was performed after 34-36 hours from hCG administration . The collection of cumulus-oocyte complexes and FFs were performed via transvaginal ultrasound-guided aspiration with a needle of 18 gauge of diameter. The three major diameter follicles were identified by intraoperative ultrasound and FF of each follicle was collected in its own test tube.
15842700|NCT04101968|Diagnostic Test|PET scan|3 PET scans to analyze the dopamine metabolism, acetylcholine and tau protein deposition in the brain.
15842701|NCT04101968|Diagnostic Test|neuroQWERTY|Analysis of free-text typing in a computer and/or a touch-screen device.
15842702|NCT04101955|Procedure|Incisionless Threaded Carpal Tunnel|ultra-minimally invasive thread carpal tunnel release
15842703|NCT04101955|Procedure|Standard Mini-Open Carpal Tunnel|open surgical carpal tunnel release
15842704|NCT04101942|Behavioral|Internet-based CBT|The experimental group will go through active internet-based treatment which is delivered on a safe internet platform. Treatment is divided into four modules, each containing homework assignments. Participants in experimental group will be assigned a therapist that they can contact through a message system in the platform and expect answer within 36 hours.
15842705|NCT04101929|Drug|Apatinib|Patients receive Apatinib 250mg po qd , Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity，death or begin a novel therapeutic.
15842706|NCT04101929|Drug|S-1 capsule|Patients receive S-1 capsule According to the body surface area <1.25m2 60mg/d, 1.25 ~ 1.5 m2 80 mg/d, > 1.5m2 100mg/d po bid, taking 7 days, stopping for 7 days, 28 days for 1 cycle, Treatment repeats until the disease recurrence or unacceptable toxicity，death or begin a novel therapeutic.
15842707|NCT04101929|Drug|Irinotecan|"Patients receive Irinotecan According to the body surface area of 180 mg/m2, ivgg/90min, once every two weeks. Continuous chemotherapy until the criteria for discontinuation of the drug are met (eg, progression of the disease, intolerance of adverse reactions, or withdrawal of informed consent by the patient).
~Because the toxicity of apatinib or irinotecan or tigeol in the chemotherapy regimen meets the withdrawal criteria, the drug can be discontinued alone and the exact duration of the trial treatment recorded."
15842708|NCT04101916|Device|Paired associative stimulation|Paired associative stimulation (PAS) administered several times per week for 12 weeks to upper limbs. PAS comprises transcranial magnetic stimulation (eXimia magnetic stimulator, Nexstim Ltd, Helsinki, Finland) and peripheral nerve stimulation (given with Dantec Keypoint® electroneuromyography device (Natus Medical Incorporated, Pleasanton, CA, USA)).
15842709|NCT04101916|Device|Sham paired associative stimulation|Sham transcranial magnetic stimulation and sham peripheral nerve stimulation.
15842710|NCT04101903|Diagnostic Test|The 6-week Hip Checklist|Comprehensive 9-item structured guide for correct diagnosis of developmental dysplasia of the hip. Used in paper and electronic format. Seeks to improve the ability of doctors in evaluating infants hips.
15842711|NCT04101890|Drug|Diaper care with Theraworx|Theraworx foam formulation to be used as a preventive and treatment agent for diaper rashes
15842712|NCT04101877|Drug|Bevacizumab Injection|25 mg/ml
15842713|NCT04101877|Drug|Aflibercept Injection|40 mg/ml
15842714|NCT04101864|Procedure|Electromagnetic navigation|Acetabular component placement in total hip arthroplasty will be performed wit the help of electromagnetic image-less navigation system.
15842715|NCT04101864|Procedure|Freehand|In the control group acetabular components in total hip arthroplasty will be placed with the help of the freehand technique.
15842716|NCT04101851|Procedure|omission of SLNB|After radiologic complete remission at the end of NAST all patients will be treated with breast-conserving surgery alone without any axillary surgery.
15842717|NCT04101838|Drug|Fluzone|inactivated seasonal influenza vaccine
15842718|NCT04101838|Drug|Flucelvax|inactivated seasonal influenza vaccine
15842719|NCT04101838|Drug|Fluzone High-Dose|inactivated seasonal influenza vaccine
15842720|NCT04101838|Drug|Fluad|inactivated seasonal influenza vaccine
15842721|NCT04101825|Device|Auralya|Hyaluronic Acid-Dermal Filler
15842722|NCT04101812|Drug|pegylated liposomal doxorubicin (PLD)|PLD is an anthracycline topoisomerase II inhibitor that is encapsulated in liposomes for intravenous use.
15842723|NCT04101812|Drug|PD-1|PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands and PD-L1.
15842724|NCT04101799|Behavioral|For Our Children's Sake|Parental support with the aim to support positive parenting and promote healthy child development. Conducted in group-format with weekly 2.hour sessions conducted by trained group leaders according to a programme manual.
15842725|NCT04101799|Other|Active control|Participating in everyday activities that may include parenting activities in the control prisons
15842726|NCT04101786|Other|Hip adductors exercise variations|The participants will perform different exercise variations targeting hip adductors in randomized order.
15842727|NCT04101773|Procedure|RBL versus sutured mucopexy versus haemorrhoidectomy.|All 3 interventions are part of Dutch usual care, and serve as each other's control.
15842728|NCT04101760|Drug|Long-acting granulocyte colony stimulating factor|Patients will accept long-acting granulocyte colony stimulating factor at 48 hour after the chemotherapy
15842729|NCT04101760|Drug|Short-acting granulocyte colony stimulating factor|Patients will accept short-acting granulocyte colony stimulating factor followed regular or prophylactic patterns
15842730|NCT04101734|Device|Double Lumen Endotracheal Tube.|Intubation was performed with Double Lumen Endotracheal Tube.
15842731|NCT04101734|Device|Double Lumen Video Endotracheal Tube.|Intubation was performed with Double Lumen Video Endotracheal Tube.
15842732|NCT04101721|Drug|aflibercept|Administered IVT
15842733|NCT04101721|Procedure|laser photocoagulation|Transpupillary conventional laser will be administered according to standard local procedures.
15842734|NCT04101708|Drug|Lansoprazole, Amoxicillin|high dose dual regimen
15843346|NCT04096287|Biological|PNT001|PNT001 diluted in 5% dextrose
15842735|NCT04101708|Drug|Lansoprazole, Amoxicillin,Clarithromycin and Bismuth subcitrate|half-dose clarithromycin-containing bismuth quadruple regimen
15842736|NCT04101695|Device|tDCS|Ybrain tDCS System (Ybrain, Korea) is used for anodal stimulation of cerebellar hemisphere. Anode of tDCS is placed over right cerebellar hemisphere (3cm lateral from the occipital protuberance) and cathode over the on right buccinator muscle.
15842737|NCT04101682|Drug|Bupivacaine|Administered by an anesthesiologist or certified nurse anesthetist, under ultrasound guidance a catheter placed overlying the nerve sheath. This catheter is then connected to a device with a reservoir that administers local anesthetic at a set rate.
15842738|NCT04101669|Device|EndoBarrier Liner|The EndoBarrier System is provided as a single-use, sterile device and consists of an EndoBarrier Liner preloaded, packaged and sterilized within the EndoBarrier Delivery System. The EndoBarrier Delivery System is utilized to deliver the EndoBarrier Liner to the proximal small intestine. The EndoBarrier Liner is removed using the EndoBarrier Retrieval System. The EndoBarrier System incorporates no pharmacological, biological tissue or blood products.
15842739|NCT04101669|Other|Sham|Patient receives upper endoscopy but no treatment
15842740|NCT04101643|Drug|evolocumab|Eligible patients receive subcutaneous injections of evolocumab 420 mg
15842741|NCT04101630|Behavioral|Activity Monitoring|Monitoring with FitBit
15842742|NCT04101617|Behavioral|Oral Health education including printed educational material|Printed and online educational materials were developed and provided to pediatricians so they can share relevant information about caries control to parents of toddlers. A previous interview was performed to pediatricians as focus groups to know how they are doing their evaluations and what do they take into account during the children visits in order to identify where to focus for the training what it is necessary to change. After that pediatricians were trained to give oral health recommendations. So, to the intervention group, the pediatricians will give these recommendations to the parents and also they will give them a printed educational material previously developed for the project.
15842743|NCT04101604|Other|Collection of blood samples|Collection of blood samples for DNA extraction and genetic characterization, and for identification of peripheral blood biomarkers using single-cell transcriptomics and mass cytometry.
15842744|NCT04101578|Drug|Symptomatic Treatment, Steroids, Immunosuppressive Agents, Plasma Exchange(PE), Intravenous Immunoglobulin(IVIg)|Treatment regimens are determined according to the physician's judgment and preferences of the patients.
15842745|NCT04101565|Behavioral|Text4Father|Receipt of twice-weekly texts that include resource links and instructions to support behavior change (e.g., videos, infographics) and start mid-pregnancy and continuing through 2 months of age.
15842746|NCT04101552|Procedure|socket shield technique with xenophobic graft particulate and without the use of graft|the jumping gap between the implant and the shield is grafted by xenograft particulate and the control group is not grafted
15842747|NCT04101539|Device|OPTIMA-guided catheter ablation|Patients in the experimental arm will undergo supplemental ablation of OPTIMA-identified sites hypothesized to support/perpetuate chronic atrial fibrillation.
15842748|NCT04101539|Device|Standard PVI|Standard PVI for AF.
15842749|NCT04101526|Behavioral|Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference|Six sessions of Spanish-language Cognitive-Behavioral Therapy for Insomnia (CBT-I) delivered via videoconference. Sessions address topics such as sleep education, sleep hygiene, sleep compression, sleep restriction, stimulus control, relapse prevention, and cognitive restructuring.
15842750|NCT04101500|Drug|Compound Ipratropium Bromide Solution(C1) for Inhalation|The patient's condition and basic condition were the same in the experimental group and the control group.
15842751|NCT04101500|Drug|Compound Sodium Chlolate and Aminophylline Tablets(C2)|Applied only to the experimental group.
15842752|NCT04101500|Drug|Placebo Tablets|Applied only to the control group.
15842753|NCT04101487|Other|Cash Transfer|Monthly cash transfers
15842754|NCT04101487|Other|Cash Transfers and Nutrition Education|Cash transfers every month and structured nutrition education provided at household level by community health assistants based on a nutrition education handbook
15842755|NCT04101474|Drug|Ketamine|Ketamine is a high-affinity, noncompetitive N-methyl-D- aspartate (NMDA) glutamate receptor antagonist it has been used in anesthesiology for more than 50 years the time course of antidepressant response to ketamine is characterized by an initial reduction in depressive symptoms within 2 h
15842759|NCT04101448|Other|prevalence|percentage of bronchectasis in COPD and its effect as prognostic measure
15842760|NCT04101435|Biological|AdimFlu-S (QIS)|This was an open study to demonstrate the use of AdimFlu-S (QIS) (2016-2017 season) vaccine in young subjects aged between 3 years old to 17 years old. All subjects were divided into two subgroups. That were subjects aged 3 to 8 years old, who received 2 doses of 0.5 mL vaccine separated by 4 weeks, and subjects aged 9 to 17 years old, who received one dose of 0.5 mL vaccine.
15842761|NCT04101422|Behavioral|Augmented Reality 1|Participants will use an Augmented Reality (AR) application on smart phones. The AR application will create simulated examples of AR stimuli (cigarettes, lighters, ashtrays) and non-smoking related stimuli (pens, notebook, eraser).
15842762|NCT04101422|Behavioral|Augmented Reality 2|Participants will use an Augmented Reality (AR) application on smart phones. The AR application will create simulated examples of smoking related AR stimuli (cigarettes, lighters, ashtrays) as well as non-smoking images (pens, notebook, etc.). They will also be presented with real smoking (e.g., ashtray) and non-smoking (e.g., pencil) items. Their urge to smoke rating following each presentation will be compared for AR images vs. vivo items, and smoking-related vs. non-smoking related.
15842763|NCT04101422|Behavioral|Augmented Reality 3|Participants will use an Augmented Reality )AR) application on smart phones in locations and situations where they typically smoke. the application will create simulated examples of AR stimuli (cigarettes, lighters, ashtrays). Participants will have a goal of using application at least 5 times per day for 7 days. Usage and rating data will be collected in real-time.
15842902|NCT04100161|Procedure|Active rehabilitation|Progressive rehabilitation following a muscle strain injury for 3 months
15843044|NCT04099069|Procedure|anesthesia|patient was insert trachial intubation or rigid bronchoscopy with ventilation under general anesthesia
15842764|NCT04101422|Behavioral|Augmented Reality 4|Participants will use an Augmented Reality (AR) application on smart phones. The AR application will create simulated examples of AR stimuli (cigarettes, lighters, ashtrays) as well as non-smoking images (pens, notebook, etc.) Their urge to smoke rating following each presentation will be compared from baseline urge to smoke. The post-test urge to smoke will be compared between control group and extinction group.
15842765|NCT04101409|Other|Decision aids|Shared decision making with decision aids
15842766|NCT04101396|Dietary Supplement|diabetic diet|Patients with gestational diabetes will be seen by the dietitian to be taught diet modification
15842767|NCT04101383|Drug|RinGlar®|Single subcutaneous administration of RinGlar® in dose 0.6 Units/kg
15842768|NCT04101383|Drug|Lantus®|Single subcutaneous administration of Lantus® in dose 0.6 Units/kg
15842769|NCT04101370|Drug|Bosentan 125 mg|Single administered dose of Bosentan (125 mg tablet immediate release) in a fasting condition
15842770|NCT04101370|Drug|Tracleer 125Mg Tablet|Single administered dose of Tracleer® (125 mg tablet immediate release) in a fasting condition
15842771|NCT04101357|Drug|BNT411|intravenous
15842772|NCT04101357|Drug|Atezolizumab|intravenous
15842773|NCT04101357|Drug|Carboplatin|intravenous
15842774|NCT04101357|Drug|Etoposide|intravenous
15842775|NCT04101344|Other|Two fiber-blend snack and four fiber-blend snack|All subjects will complete a 47-day, multi-phase feeding study to evaluate the effect of two snack prototypes containing two different fiber blends on gut community structure and features of host biological state (plasma proteome/ metabolome).
15842776|NCT04101331|Drug|AFM13|weekly intravenous infusions of 200mg
15842777|NCT04101318|Device|New Stoma Baseplat based on the Sensuro Mio product line.|New Stoma Baseplate based on the Sensuro Mio product line. New Baseplate is not named at this point, but has a new protective layer.
15842778|NCT04101305|Diagnostic Test|IsoPic|Biomimetic circulating epithelial cell enrichment followed by epithelial cell detection and single cell DNA sampling and sequencing
15842779|NCT04101292|Other|Characterization of tumor tissue by fluorescence|"HSI Imaging of the resected specimen, from the serum and the mucous side
~FF-OCT imaging of the tumor and the healthy tissue biopsies
~Local application of Bevacizumab-IRDye800CW and visualization with the Surgvision Explorer system
~Standard anti-VEGF Immunohistochemistry and pathology"
15842780|NCT04101279|Procedure|surgical management of stress urinary incontinence with midurethral tension free tape.|Standard protocol for the surgical treatment of stress urinary incontinence using a transobturator approach.
15842781|NCT04101279|Procedure|surgical management of stress urinary incontinence with synthetic tape with tension control mechanism.|Standard protocol for the surgical treatment of stress urinary incontinence using a transobturator approach. A absorbing gasket attached to the middle of the tape provides tension control.
15842782|NCT04101266|Other|Interscalene block|30 minutes before anaesthesia induction interscalene nerve block will be applied with ultrasound guidance with %0,25 bupivacain 20 cc .The sham block consisted of after patients were placed in the lateral decubitus position skin preparation, ultrasound scanning of the suprascapular region, and a dry-needling, all performed to preserve patient blinding in the ISB group patients.
15842783|NCT04101266|Other|suprascapular and infraclavicular nerve block|30 minutes before anaesthesia induction suprascapular with %0,25 bupivacain 10 cc .and infraclavicular nerve block with %0,25 bupivacain 10 cc will be applied with ultrasound guidance
15842784|NCT04101253|Procedure|new screening procedure with small variations in electrode positioning|"Every ICD patient will undergo the standard screening process. Initial screening will be performed as usually performed by physician or Boston Scientific technical support. In case of one or more vector satisfying screening criteria, patient will be assigned in screening success group. In case of failure, a pre-determined electrode positioning protocol will be done with variation of para-sternal and axillary electrodes. Positioning variations will be left to the discretion of the operator cardiologist."
15842785|NCT04101227|Drug|AD04 (ondansetron)|AD04 (ondansetron) 0.33 mg, orally (p.o.) twice a day (BID)
15842786|NCT04101227|Drug|Matching placebo|Matching placebo to AD04 (ondansetron), orally (p.o.) twice a day (BID)
15842787|NCT04101227|Device|Companion Diagnostic for Genetic Testing|Companion Diagnostic for Genetic Testing
15842788|NCT04101227|Behavioral|Brief Psychological Counseling|Brief Psychological Counseling
15842789|NCT04101214|Other|Dry needling|Dry needling into spastic muscle
15842790|NCT04101214|Other|Sham dry Needling|Sham dry needling into spastic muscle
15842791|NCT04101201|Dietary Supplement|µSmin® Plus|µSmin® Plus is a new Micronized Diosmin Formulation for oral administration. Diosmin is extremely well tolerated and safe to use. Diosmin is safe for most people when used short-term for up to 6 months. During the 8 weeks of the clinical investigation, the subject will administer 1 tablet of µSMIN® Plus (corresponding to 450 mg of micronized diosmin) or placebo per day.
15842792|NCT04101201|Other|Placebo|It will be supplied by the Sponsor in an amount enough for the duration of the study. The subject will administer 1 tablet per day
15842793|NCT04101188|Other|Moderate Potassium/Low Sodium Diet|Consumption of 10 days of a diet moderate in potassium and low in sodium.
15842794|NCT04101188|Other|Moderate Potassium/High Sodium Diet|Consumption of 10 days of a diet moderate in potassium and high in sodium.
15842795|NCT04101188|Other|High Potassium/High Sodium Diet|Consumption of 10 days of a diet high in potassium and high in sodium.
15842796|NCT04101175|Procedure|Evaluation of the procedure of abortion|Observational study using questionnaires
15842797|NCT04101162|Diagnostic Test|shear waves elastography; liver biopsy|Diagnostic accuracy in a new ultrasound software compared to histology for Non Alcoholic Fatty liver disease (NAFLD) and Non Alcoholic Steato Hepatitis (NASH)
15842798|NCT04101149|Other|No intervention|No intervention.
15842799|NCT04101136|Drug|Atorvastatin - placebo controlled clinical trial|The participants will get the medication supply every month along with the refill of antiretroviral drugs. The drug and placebo tablets will be administered to patients by a staff member who are privy to the treatment. In the end of every month, each participant should return the unused pills every month
15842800|NCT04101123|Other|Non-Interventional|Non-Interventional
15842801|NCT04101110|Other|Renal biopsy|Kidney biopsy will be done to understand the nature and degree of structural kidney damage
15842802|NCT04101084|Other|Therapy|Rocking sessions in a safe rocking chair for 2 hours daily for six weeks
15842803|NCT04101071|Other|Modular ketogenic feed|Dietician prescribed, and consisting of Betaquik® (from Vitaflo, Nutritional company) to provide medium chain triglycerides), Renapro Shot® (protein), Maxijul® (carbohydrate) and multivitamins according to nutritional need (energy and protein requirements) based on clinical status of the participant. Ketogenic feed to be given continuously via nasogastric tube for 10 days
15842804|NCT04101071|Other|Standard feed|Standard Enteral feed. Dietician prescribed based on clinical status of the participant, as per individual Trust protocols. Standard feed to be given continuously via nasogastric tube for 10 days
15842805|NCT04101045|Diagnostic Test|Oral Glucose Tolerance Test|Each participant consumes a dinner scaled to his/her energy needs which is prepared by the metabolic kitchen. Dinner will be provided beforehand if patient does this portion at home. The participant consumes the first of three doses of D2O. Two additional doses of D20 are given at on day 1 and on day 2. The total D2O given (3 ml per kg of body water) is designed to raise body deuterium levels to 0.3% and is administered as described above to maintain steady state until the end of the study. At the HRU, an IV catheter will be inserted in order to collect blood to assess DNL. Blood draws begin during the fasting state to assess basal rates of DNL and then for six hours after the consumption of a glucose/fructose beverage (75g glucose and 25g fructose ) to assess postprandial rates of DNL. Blood draws will be taken 15 minutes before ingestion of the sugar beverage, then for every half hour for 6 hours.
15842806|NCT04101032|Behavioral|eBEfree|Contextual interventions based on promoting acceptance,mindfulness and self-compassion abilities
15842807|NCT04101019|Drug|Lidocaine|Intervention will include the SPGB block which will be performed by placing the patient supine with the neck extended and 1.5 ml of 5% lidocaine will be dripped into one or two nostrils.
15842808|NCT04101019|Drug|Saline Solution|Intervention will include the SPGB block which will be performed by placing the patient supine with the neck extended and 1.5 ml of saline will be dripped into one or two nostrils.
15842809|NCT04100993|Other|No intervention used|No intervention used
15842810|NCT04100980|Other|No Intervention|There is no intervention for this study
15842811|NCT04100954|Device|Reinforced prosthesis|Implementation of a reinforced prosthesis during a medical consultation or under local anesthesia, after removal of the former prosthesis, in case of intraprothetic leakage.
15842812|NCT04100954|Device|Standard prosthesis|Implementation of a standard prosthesis during a medical consultation or under local anesthesia, after removal of the former prosthesis, in case of intraprothetic leakage.
15842813|NCT04100941|Diagnostic Test|standard suction|After the needle is inserted in the mass, removing the stylet before performing EUS-FNA. Then attach a 10mL syringe to the end of needle. 20 times of for-backward Suction was applied after the lesion was punctured.
15842814|NCT04100941|Diagnostic Test|slow pull|After the needle is inserted in the mass, slowly pull the stylet out while performing EUS-FNA with 20 times for-backward.
15842815|NCT04100941|Diagnostic Test|wet suction|After removing the stylet, the needle was flushed with 5mL of saline solution to replace the column of air with saline. A 10mL syringe was attached to the end of the needle. 20 times of for-backward Suction was applied after the lesion was punctured.
15842816|NCT04100928|Other|dental students|WEMWBS and a questionnaire included demographic details and social background, lifestyle behaviors was applied to the participants.
15842817|NCT04100915|Other|No Intervention|There is no intervention for this study
15842818|NCT04100902|Drug|ODACTRA 12 SQ-HDM Sublingual Tablet|Subjects are randomized to either HDM-AIT or Placebo for 24 weeks of therapy
15842819|NCT04100902|Drug|Placebo sublingual tablet|Subjects are randomized to either HDM-AIT or Placebo for 24 weeks of therapy
15842820|NCT04100889|Other|No Intervention|There is no intervention for this study.
15842821|NCT04100876|Genetic|Global DNA methylation will be quantified in the DNA samples by colorimetry|Global DNA methylation will be quantified in the DNA samples by colorimetry
15842822|NCT04100863|Other|No Intervention|There is no intervention for this study.
15842823|NCT04100850|Other|Aquatic Exercises|twice a week, lasting 50 minutes, for two months.
15842824|NCT04100850|Other|Watsu|twice a week, lasting 50 minutes, for two months.
15842825|NCT04100824|Procedure|stellate ganglion block by transcranial doppler|stellate ganglion block is a block of sympathetic ganglion
15842826|NCT04100824|Drug|Nimodipine|Nimodipine 60mg every 4h
15842827|NCT04100798|Procedure|Entire Papilla Preservation technique|A minimally invasive technique that allow access to the intrabony defect without affecting the interdental papilla related to it
15842828|NCT04100798|Procedure|Modified Minimally invasive Surgical Technique|a minimally invasive technique that allow access to the intrabony defect area from the buccal aspect through a horizontal incision below the papilla without elevating it.
15842829|NCT04100785|Behavioral|Internet-delivered Cognitive Behavioural Therapy|The iCBT programme comprised on 6 online modules. Module 1 provided an introduction to the symptoms of depression, its causes and information on CBT. Module 2 covered problem-solving strategies. Module 3 provided information on problematic thought patterns and beliefs in depression. Module 4 entailed identifying problematic thought patterns and using various techniques to counter problematic thoughts. Module 5 covered pleasurable activities scheduling to help increase activity levels.
15842830|NCT04100772|Biological|13-Valent Pneumococcal Polysaccharide Conjugate Vaccine（CRM197,TT）|0.5mL,Intramuscular other name:PCV13i
15842831|NCT04100772|Biological|13-Valent Pneumococcal Polysaccharide Conjugate Vaccine|0.5mL,Intramuscular other name:Prevnar
15842832|NCT04100759|Drug|Sildenafil 50 mg Oral Tablet|Sildenafil 50 mg Oral Tablet
15842833|NCT04100746|Procedure|supramalleolar osteotomy|surgical intervention by using low tibial osteotomy
15842834|NCT04100733|Diagnostic Test|Xpert Bladder Cancer Monitor|Xpert Bladder Cancer Monitor detects mRNA fragments from 5 genes frequently overexpressed in non-muscle invasive bladder cancer.
15842835|NCT04100733|Diagnostic Test|Flexible cystoscopy (WL/NBI) and urinary cytology|Adhering to current danish guidelines for follow-up of non-muscle invasive bladder cancer.
15842836|NCT04100720|Device|Cardiovalve Transfemoral Tricuspid Valve|The Cardiovalve Transfemoral Tricuspid Valve System is intended for use in patients with severe, symptomatic Tricuspid regurgitation
15842929|NCT04100005|Other|No intervention|There is no intervention for this study.
15843347|NCT04096287|Drug|Placebo|5% dextrose
15842837|NCT04100707|Procedure|Genicular block was applied|This procedure is performed with ultrasound and / or fluoroscopy, sterile staining and covering of painful knee to the middle of thigh and leg, localization of superomedial, superolateral, inferomedial genicular nerves are tested and then conventional radiofrequency is applied to all 3 nerve regions
15842838|NCT04100694|Drug|MCLA-128|
15842839|NCT04100681|Device|Active FlowOx™|Treatment is done by the patient at home for about 2 hours per day. Recommended to be 1 hour in the morning and 1 hour in the afternoon.
15842840|NCT04100681|Device|Sham FlowOx™ (Placebo)|Treatment is done by the patient at home for about 2 hours per day. Recommended to be 1 hour in the morning and 1 hour in the afternoon.
15842841|NCT04100668|Device|Sensifree's Alpha sensor|RF based, wrist mounted sensor, that acquires a high fidelity signal originating at the radial artery, and constructs a pressure waveform
15842842|NCT04100668|Device|Arrow® arterial catheterization kit (Teleflex)|Invasive monitoring of blood pressure via catheterization of the radial artery, displaying a continuous pressure waveform
15842843|NCT04100668|Device|GE Datex-Ohmeda Oxy-F Finger Clip Pulse Oximeter Sensor|PPG based, fingertip mounted sensor, that measures the oxygen level (oxygen saturation) of the blood and generates a waveform
15842844|NCT04100655|Drug|GM-CSF|3ml GM-CSF gel will be irrigated into the uterine cavity immediately when hysteroscopy is complete. Then same dose gel will be given every other day twice
15842845|NCT04100655|Drug|17-ß estradiol|A hormone replace treatment by 17-ß estradiol (6mg per day) follows next cycle to prepare for embryo transfer
15842846|NCT04100642|Drug|Hemay808|topical apply
15842847|NCT04100642|Drug|Placebo|topical apply
15842848|NCT04100629|Behavioral|digital support: text messages|In this study, the text messages are intended to be one-directional, from the PI to the participant. Participants are not expected to reply. If participants reply to any of the text messages, the PI will screen the content and only reply if it is a question regarding the study or a request to seek counseling. Additionally, participants will be instructed by the PI to access their Smartphones to read texts while on a break, after their shift, or when not at work; participants will be instructed to not use Smartphones to read texts while working. A series of four text messages will be sent to all study participants (experimental and control groups) by the PI every Monday, Wednesday, Friday, and Saturday (M, W, F, S) at 1pm for six weeks, for a total of 24 different texts for each group.
15842849|NCT04100616|Other|No intervention|There is no intervention for this study
15842850|NCT04100603|Other|No Intervention|There is no intervention for this study
15842851|NCT04100590|Drug|Cannabis|Smoked active cannabis (7% THC) vs. placebo inactive cannabis (0% THC)
15842852|NCT04100577|Other|Today Not Tomorrrow Pregnancy and Infant Support Program|The Today Not Tomorrow Pregnancy and Infant Support Program (TNT-PISP) is a collaborative community-based support group uniquely designed to serve black women and infants through once monthly group sessions delivered prenatally and in the immediate postpartum period.
15842853|NCT04100564|Device|Supraglottic airway device|Initial advanced airway management with a supraglottic device
15842854|NCT04100564|Other|Standard airway management|Initial advanced airway management with standard care method
15842855|NCT04100538|Behavioral|health coach|"The health-coaching program includes (1) my file, (2) lesson, (3) self-assessment, and (4) interaction modules. My file allows participants recording their disease history. The lesson includes knowledge of fibromyalgia, stress and relaxation, emotion and positive thinking, sleep hygiene, communication skills, and exercise. The self-assessments includes symptom diary, exercise and general diary. The interaction encourages participants interacting with peers and the health coach. Participants can share practical advices, strategies, real-life examples or questions via texts or photos in share garden. Participants can connect to the health coach via contact with health coach. The coach will provide comments or responses approximately 10-30 min for each time. The coach will monitor each participant's lesson list and attendance for each lesson. The health coach will also guide the participants to create their own tailored programs according to participants' predominant symptom subtypes."
15842856|NCT04100525|Behavioral|Neuropsychological testing intervention plus follow up|Neuropsychological testing for women experiencing significant fatigue, mood, or cognitive symptoms. Feedback type and case management services varied depending on randomized group.
15842857|NCT04100512|Device|Oscillating Positive Expiratory Pressure Device|Aerobika® Oscillating Positive Expiratory Pressure (OPEP) device is a drug-free, easy to use, hand-held device with a proprietary pressure-oscillation dynamic that provides intermittent resistance and creates positive pressure and oscillations simultaneously. The Aerobika® OPEP device opens weak or collapsed airways to mobilize and assist mucociliary clearance to the upper airways where it can be coughed out.
15842858|NCT04100512|Device|Incentive spirometry|An incentive spirometer is a device that measures how deeply you can inhale (breathe in). It helps you take slow, deep breaths to expand and fill your lungs with air. The incentive spirometer is made up of a breathing tube, an air chamber, and an indicator.
15842859|NCT04100499|Device|ESAR (Endosutured Aneurysm Repair)|EndoAnchors adjunctive therapy for EVAR and TEVAR
15842860|NCT04100486|Other|Standing-Squatting-Standing Test|The participant will begin by actively standing for one minute, followed by a transition to a squat for one minute, and one last transition to one minute of standing.
15842861|NCT04100486|Other|Deep Breathing Test|The participant will be asked to lay down for seven minutes and take long, controlled breaths at a rate within 4 to 10 breaths per minute.
15842862|NCT04100486|Other|Cold Pressor Test|The participant will be asked to immerse their hand into ice water (1- 10°C) for up to three minutes, followed by removal of the hand from the bath and continuation for recording for a further three to five minutes. The participant will be informed that he or she can remove his or her hand at any point if there is discomfort.
15842863|NCT04100486|Other|Cold Face Test|The cold stimulus will be applied with refrigerated gel-filled compresses places on the forehead and cheeks of the participant for one minute.
15842864|NCT04100486|Other|Valsalva Maneuver|The participant will be asked to inhale deeply, pinch his or her nose, close his or her mouth, and forcibly exhale, while bearing down with tight chest and stomach muscles, for approximately 10 to 15 seconds. The sensors will continue recording as the participant recovers to normal breathing over the next one minute.
15843413|NCT04095689|Drug|L-NMMA|pan-NOS inhibitor
15842865|NCT04100486|Device|Transcutaneous Auricular Vagus Nerve Stimulation (taVNS)|The participant will receive electrical stimulation applied to their ear for five minutes. The threshold for stimulation will be determined before the test begins at a level that may elicit sensation (tickling, vibrating, pricking), but no pain. There is a possibility that the participant will receive sham stimulation, or inactive stimulation, for this test.
15842866|NCT04100473|Drug|Inhaled Human Insulin|Dance 501 administered using the Dance 501 Inhaler
15842867|NCT04100473|Drug|Insulin Lispro (Humalog U-100)|Lispro
15842868|NCT04100460|Dietary Supplement|7.25 grams of Arabinoxylan leaf fiber extract|Participants are given 7.25 grams of Arabinoxylan daily
15842869|NCT04100460|Dietary Supplement|14.5 grams of Arabinoxylan leaf fiber extract|Participants are given 14.5 grams of Arabinoxylan daily
15842870|NCT04100460|Dietary Supplement|Control - No Arabinoxylan|Participants are given no Arabinoxylan
15842871|NCT04100447|Drug|Tranexamic Acid|A total of 700 mL of study drug should be completely consumed orally 2-12 hours prior to surgery as a split dose; 350 mL 6-12 hours prior to surgery and the remaining 350 mL 2-6 hours prior to surgery.
15842872|NCT04100434|Drug|Evolocumab|Patients were randomly assigned of the ratio of 1:1 using a computer-generated random number and divided into two treatment groups: the statin alone therapy and the evolocumab plus statin therapy.
15842873|NCT04100408|Other|Biospecimen Collection|Undergo saliva or buccal mucosa collection
15842874|NCT04100408|Other|Laboratory Biomarker Analysis|Correlative studies
15842875|NCT04100408|Other|Questionnaire Administration|Ancillary studies
15842876|NCT04100395|Device|sonoclot|Sonoclot Analyzer is best described as a microviscometer. The electronics are sensitive to any resistance to motion that the oscillating probe encounters as it moves within the test sample.
15842877|NCT04100382|Device|Laser and SLA|Patients will be randomized into two groups, control group for SLA implants, and study group will receive the Laser treated implants. Implants will be placed classically in the posterior maxillary region and their stability will be measured by ISQ device at the placement. Measurements will be taken again at 2, 4, 6, 8 , 10 and 12 weeks.
15842878|NCT04100369|Diagnostic Test|laboratory|Arm
15842879|NCT04100356|Other|Exercise|Exercise program - indoor bicycle interval exercise, duration 60 min 3x week
15842880|NCT04100356|Other|Normal Diet|Normal diet recommended by the health authorities
15842881|NCT04100356|Other|LCHF Diet|LCHF Diet, a modified Atkins diet with high percentage of fat and very low percentage of karbohydrates
15842882|NCT04100330|Biological|Ficlatuzumab|Ficlatuzumab is a selective recombinant humanized hepatocyte growth factor (HGF) inhibitory immunoglobulin G subclass 1 monoclonal antibody which blocks the MET tyrosine kinase receptor.
15842883|NCT04100330|Drug|Cytarabine|Cytarabine is a chemotherapy agent. Chemotherapy agents are medications that kill cancer cells.
15842884|NCT04100304|Diagnostic Test|resection|CT volumetry,liver function,biopsy before resection
15842885|NCT04100291|Other|Faecal microbiota transplantation|FMT by daily enema with donor faeces
15842886|NCT04100291|Other|Placebo|Placebo by daily enema with placebo mixture
15842887|NCT04100278|Behavioral|Shared Care diabetes management|After the inclusion visit, the patients will be randomized to Shared Care group or traditional therapy group. Compared to conventional diabetes education in the traditional therapy group, the Shared Care group provides patients with online services and continuous diabetes management and education through a mobile application. It also addresses that it is important for patients to meet regularly with diabetes multidisciplinary team for better results. The total observation period is 3 years for each patient. The visits will be done every 3 months.
15842888|NCT04100265|Device|Panel 1 - High risk for postoperative ileus (VIPUN Gastric Monitoring System)|The VIPUN Gastric Monitoring System prototype 0.3 comprises a nasogastric balloon catheter which is connected to an extracorporeal pressure sensor and data acquisition system. The device is placed during surgery.
15842889|NCT04100265|Device|Panel 2 - Postoperative ileus arm with investigational device (VIPUN Gastric Monitoring System)|The VIPUN Gastric Monitoring System prototype 0.3 comprises a nasogastric balloon catheter which is connected to an extracorporeal pressure sensor and data acquisition system. The device is placed upon the manifestation of clinical signs of postoperative ileus.
15842890|NCT04100252|Other|AFI via transabdominal ultrasonography|AFI via transabdominal ultrasonography was performed at the time of diagnosis.
15842891|NCT04100239|Behavioral|Mindfulness-based stress reduction (MBSR)|MBSR is designed to complement any existing medical treatments, and focuses on the development of mindfulness meditation practice to alleviate psychological distress. MBCL is designed as a follow-up intervention to MBSR and aims to help individuals to turn towards suffering and developing a kind attitude to the self.
15842892|NCT04100226|Dietary Supplement|Vitamin D3 (1.25 (OH)2 cholecalciferol)|"Vitamin D 3 in a dose of 200.000 IU intramuscular injection every 2 weeks for 3 months for Vitamin D deficient interstitial lung disease patients and every month for 3 months for vitamin D insufficient interstitial lung disease patients.
~calcium supplementation in form of ca carbonate 600 mg oral capsule once daily for 3 months for all patients."
15842893|NCT04100213|Behavioral|Trier Social Stress Test|The TSST-G is a psychological paradigm which combines high levels of social-evaluative threat and uncontrollability in a group setting. The TSST-G will proceed in groups of three to five participants (from the same diagnostic group). The TSST-G consists of three phases: a briefing; the psychological test itself, followed by a debriefing phase. Each phase will last 40, 20 and 60 minutes, respectively. The briefing and debriefing of the TSST-G will be conducted by experienced psychotherapists. The TSST-G itself will be conducted by personal unknown to the participants.
15842894|NCT04100200|Dietary Supplement|Mixed berries|Strawberry and red raspberry
15842895|NCT04100200|Dietary Supplement|FOS|Fructo-oligosaccharide
15842896|NCT04100200|Dietary Supplement|Control|Placebo similar in color to mixed berry supplement without any polyphenols
15842897|NCT04100200|Dietary Supplement|Combination|Mixed berry composite + FOS
15842898|NCT04100187|Biological|Anti-CD19-CAR|Cells extracted, followed by induction chemotherapy before CD19-CAR infusion (dose escalation.)
15842899|NCT04100174|Radiation|focal brachytherapy boost to SBRT|As above
15842900|NCT04100161|Dietary Supplement|Protein supplementation|Daily dose of 40 g whey protein for 3 months
15842901|NCT04100161|Dietary Supplement|Carbohydrate supplementation|Daily dose of 40 g maltodextrin for 3 months
15842903|NCT04100148|Device|SyncAV programmed ON|For those subjects randomized to SyncAV programmed ON, sites will measure QRS duration with the subject's intrinsic rhythm (pacing OFF), at BiV pacing nominal settings, with various SyncAV programmed offsets, and at LV first 30 ms, RV first 30 ms and LV-only pacing with optimal SyncAV offsets. The site will then program the subject's device using the SyncAV offset that provided the narrowest QRS duration.
15842904|NCT04100148|Device|Fixed AV delay|For those subjects randomized to the fixed AV delay arm, sites will measure QRS duration with the subject's intrinsic rhythm (pacing OFF) and at BiV pacing nominal settings. Sites will then program the subject's device using BiV pacing nominal settings.
15842905|NCT04100135|Device|Actual device PFO closure|Actual PFO closure with the GORE® CARDIOFORM Septal Occluder
15842906|NCT04100135|Drug|Thienopyridine (clopidogrel or prasugrel)|Thienopyridine tablets (clopidogrel or prasugrel) administered for 6 months following device procedure
15842907|NCT04100135|Device|Sham device PFO closure|Sham (simulated) device PFO closure with result of no device implantation and no PFO closure
15842908|NCT04100122|Procedure|Blood drawing|Blood drawn will be done once using 15 mL of blood volume (Serum or plasma samples will be collected during the routine follow up of level of sIgE to wheat or during the oral food challenge test which intravenous insertion routinely prepared in case of the emergency reaction occurred). The specimen will be transferred to the Icahn School of Medicine at Mount Sinai, New York, USA for Laboratory processing (Luminex-based peptide assay)
15842909|NCT04100109|Dietary Supplement|Polylactose|Polylactose 15 g/day
15842910|NCT04100109|Other|Placebo|Cellulose 15 g/day
15842911|NCT04100096|Drug|Brexpiprazole|Tablet
15842912|NCT04100096|Other|Placebo|Tablet
15842913|NCT04100083|Drug|Spironolactone 50 MG|"Study visit timeline: initial visit [consent and enrollment followed by baseline exam (0 months), 3 months, 6 months, and follow up at 7 months, with optional treatment extension period for up to one year of total treatment during which patients will follow up every 3 months
~The drug will be taken via oral tablets once daily for a duration of 6 months. Patients will be instructed to continue any current treatment regimen for hidradenitis suppurativa that was initiated at least 4 weeks prior to their enrollment in the study. Patients will be instructed to avoid potassium supplements and foods containing high levels of potassium, including salt substitutes, which could potentially lead to hyperkalemia. They will be instructed to avoid medications listed in the exclusion criteria."
15842914|NCT04100083|Drug|Spironolactone 100mg|"Study visit timeline: initial visit [consent and enrollment followed by baseline exam (0 months), 3 months, 6 months, and follow up at 7 months, with optional treatment extension period for up to one year of total treatment during which patients will follow up every 3 months
~The drug will be taken via oral tablets once daily for a duration of 6 months. Patients will be instructed to continue any current treatment regimen for hidradenitis suppurativa that was initiated at least 4 weeks prior to their enrollment in the study. Patients will be instructed to avoid potassium supplements and foods containing high levels of potassium, including salt substitutes, which could potentially lead to hyperkalemia. They will be instructed to avoid medications listed in the exclusion criteria."
15842915|NCT04100083|Drug|Spironolactone 200 mg|"Study visit timeline: initial visit [consent and enrollment followed by baseline exam (0 months), 3 months, 6 months, and follow up at 7 months, with optional treatment extension period for up to one year of total treatment during which patients will follow up every 3 months
~The drug will be taken via oral tablets once daily for a duration of 6 months. Patients will be instructed to continue any current treatment regimen for hidradenitis suppurativa that was initiated at least 4 weeks prior to their enrollment in the study. Patients will be instructed to avoid potassium supplements and foods containing high levels of potassium, including salt substitutes, which could potentially lead to hyperkalemia. They will be instructed to avoid medications listed in the exclusion criteria."
15842916|NCT04100070|Behavioral|Monitoring of the patients|"Follow-up of the patients during the 12 months study periods including :
~visits with the diabetologist/pediatrician
~contacts with the service provider (nurses' visits) (more in intensive group)
~personalized monitoring of glycemic data transferred to the diabetologist/pediatrician for each visit (only in intensive group)"
15842917|NCT04100057|Behavioral|Cognitive Behavioral Therapy for Insomnia (CBT-I)|CBT-I improves sleep through a combination of behavioral interventions (stimulus control (SC), sleep restriction (SR)), cognitive therapy (CT) as well as additional components such as mindfulness training and sleep hygiene education. SC is an intervention that re-establishes the connection between the bed/bedroom with sleep to help develop a more consistent sleep/wake pattern. SR leads to higher quality sleep by reducing excessive time spent in bed to the actual amount of sleep, thereby creating mild sleep deprivation and increasing the homeostatic sleep drive. Like CT for other disorders, CT for insomnia targets maladaptive thoughts and cognitions that may interfere with sleep.
15842918|NCT04100057|Behavioral|Desensitization Therapy for insomnia (DT-I)|"DT-I is a quasidesensitization treatment presented as a means of eliminating the conditioned arousal, which prolongs nocturnal awakenings. DT-I has been validated as an active-placebo control condition. Therapists help each DT-I recipient develop a chronological 12-item hierarchy of common activities he/she does on awakening at night (e.g., opening eyes, clock watching). Therapists also help them develop 6 imaginal scenes of themselves engaged in neutral activities (e.g., reading the newspaper). Each session, DT-I recipients are taught to pair neutral scenes with items on the 12-item hierarchy so, by the end of the sixth session, all hierarchy items have been practiced with therapist assistance. Each session, the exercise is tape recorded and the patient is given this tape locked in a player. The patients are told to practice their exercises at home once each day, no less than 2 hours before bedtime, but to avoid using the tape or exercise during sleep periods."
15842919|NCT04100044|Other|Exercise Counseling|Meet with physical therapist
15842920|NCT04100044|Behavioral|Exercise Intervention|Receive personalized home exercise intervention
15842921|NCT04100044|Other|Questionnaire administration|Ancillary studies
15842922|NCT04100044|Other|Quality-of-Life Assessment|Ancillary studies
15842923|NCT04100031|Device|bandage contact lenses|wear bandage contact lensesfor a week after cataract surgery.
15842924|NCT04100031|Procedure|phacoemulsification|underwent standard phacoemulsification through a 2.8-mm clear corneal temporal incision and intraocular lens
15842930|NCT04099992|Behavioral|Mindfulness-based stress reduction (MBSR)|Mindfulness-based stress reduction (MBSR) is delivered in 8 weekly 2.5-hour group sessions and one day-long retreat that occurs after the 6th session. MBSR teaches to become more aware of thoughts, feelings, and sensations, and to skillfully respond to stressors. Each of the sessions includes education about mindfulness and stress; experiential mindfulness practice, and discussion of participants' experiences with mindfulness practice. Participants learn formal mindfulness practices (e.g., meditation, yoga, body scan, body scan) as well as informal such as awareness of breath, thoughts, or emotions, and mindfulness of daily activities. Participants will receive digital audio (MP3) downloads with guided MM practices, a home practice manual, and handouts with each week's assignments. Daily home practice will consist of 40-45 minutes of recorded practice. Participants will log their daily practice. If a participant misses a class, it is possible to make up the class on a different day.
15842931|NCT04099992|Behavioral|Health enhancement program (HEP)|"8-week health enhancement program (HEP) is designed to provide a structurally parallel, active control intervention to MBSR with health benefits in their own right, while omitting any components of mindfulness. HEP matches MBSR in structure and content, and in parallel to MBSR, consists of music therapy, nutritional education, posture and balance movements, walking and stretching. Work with all practices with group discussion and exercises during an all-day spa day will match the all-day retreat in MBSR. HEP participants will meet with a health educator in a group setting for 8 weekly 2.5-hour sessions. Participants will receive MP3 downloads on an MP3 player with recordings of health education topics, a home listening manual, and weekly handouts with each week's listening assignments. Participants will listen to these MP3 recordings daily for 40-45 minutes and log their daily adherence."
15842932|NCT04099992|Device|Transcutaneous Vagus Nerve Stimulation (tVNS)|Transcutaneous Vagus Nerve Stimulation (tVNS) is delivered using gammaCore (Electrocore), a multi-use, hand-held, rechargeable portable device consisting of a rechargeable battery, signal generating and amplifying electronics, and a button for operator control of the stimulation intensity. Conductive gel is applied to the stainless steel round discs on the device and placed vertically on the skin overlying the vagus nerve under the angle of the mandible, between the trachea and sternocleidomastoid muscle. A low-voltage electrical signal is delivered consisting of 5-kilohertz (kHz) sine wave series for 1 ms and repeated every 40 ms, with a maximum delivery of 24 V and 60 milliampere (mA) output. Stimulation amplitude is adjusted by the user and is increased until there is a vibration and slight muscle contraction in the lower face or neck. Stimulation is delivered for 2 minutes on the left side of the neck, and 2 minutes on the right side of the neck, for a total 4 minutes per one dose.
15842933|NCT04099992|Device|Sham-transcutaneous Vagus Nerve Stimulation (tVNS)|Sham stimulation will be delivered using a sham device that is identical in appearance and function, but programmed to produce a lower frequency biphasic signal that can be felt by the participant without actually stimulating the vagus nerve.
15842934|NCT04099979|Other|No Intervention|There is no intervention for this study
15842935|NCT04099966|Drug|alpha beta depletion|donor cells will be collected and subsequently undergo α/β CD3+/CD19+ cell depletion.
15842936|NCT04099953|Diagnostic Test|Hand grip, joint range of motion , functional level of the upper extremity, physical activity levels|Hand grip force with Jamar Hand Dynamometer, joint range of motion with Baseline Digital Goniometer, functional level of the upper extremity with the Shoulder-Arm and Hand Problems Questionnaire(DASH), physical activity levels with International Physical Activity Questionnaire Short Form(IPAQ-short form) and physical functions with Human Activity Profile (HAP) were evaluated.
15842937|NCT04099940|Behavioral|Virtual Reality Avatar Therapy (VRAT)|The Virtual Reality Avatar Therapy (VRAT) is a Cognitive Behavioral Intervention, delivered through Virtual Reality.
15842938|NCT04099940|Behavioral|Assertiveness Training Program (ATP)|The Assertiveness Training Program (ATP) is a Cognitive Behavioral Intervention, delivered as group therapy.
15842939|NCT04099927|Drug|SHR0410|SHR0410 monotherapy,given intravenously
15842940|NCT04099901|Drug|Anakinra|Subjects will be treated with a daily dose of 300 mg anakinra, intravenously, starting on day -2, until day +12 (day 0 is day of SCT).
15842941|NCT04099901|Drug|Placebos|Subjects will be treated with a daily dose of placebo, intravenously, starting on day -2, until day +12 (day 0 is day of SCT).
15842942|NCT04099888|Drug|Fimaporfin and Gemcitabine|PCI treatment consists of IV administration of Amphinex solution for injection (investigational product) at 0.22 mg/kg dose of fimaporfin, followed 4 days later by a standard dose of gemcitabine infusion (1000 mg/m²) and intraluminal laser light application. Up to 2 PCI treatments will be given.
15842943|NCT04099888|Drug|Gemcitabine/Cisplatin chemotherapy|Up to 8 cycles of gemcitabine/cisplatin combination chemotherapy will be administered.
15842944|NCT04099875|Diagnostic Test|ultrasound|Ultrasound is a type of imaging. It uses high-frequency sound waves to look at organs and structures inside the body.
15842945|NCT04099862|Procedure|ERCP|Endoscopic retrograde cholangiopancreatography (ERCP)
15842946|NCT04099862|Procedure|EUS-BD|Endoscopic UltraSound Biliary Drainage
15842947|NCT04099849|Dietary Supplement|Diet-ZnBfR: Zinc biofortified rice-based diet|Diet-ZnBfR: Zinc biofortified rice-based diet
15842948|NCT04099849|Dietary Supplement|Diet- CR: Conventional rice-based diet|Diet- CR: Conventional rice-based diet
15842949|NCT04099849|Dietary Supplement|CR + Zn: Conventional rice-based diet plus zinc fortificant (Diet-CR+Z).|CR + Zn: Conventional rice-based diet plus zinc fortificant (Diet-CR+Z).
15842950|NCT04099836|Drug|Atezolizumab|1200 mg IV
15842951|NCT04099836|Drug|Bevacizumab|15 mg/kg IV
15842952|NCT04099823|Other|MRI screening form|Participants will be asked to complete a MRI screening form to check for the presence of metallic implants and materials. People with pacemakers, aneurysm clips, and cochlear implants, or metal/foreign objects in their eyes cannot have an MRI and will not be able to participate in the study.
15842953|NCT04099823|Diagnostic Test|Urine pregnancy test|Pre-menopausal females will be asked if they think they may be pregnant. If yes, a urine pregnancy test will be performed.
15842954|NCT04099823|Diagnostic Test|MR brain|"You will be asked to lie down on the bed of the MRI scanner. Then a MRI coil/antenna will be placed over your head. This will allow us to get clearer pictures of the tissue of interest. The MRI machine makes loud knocking sounds. Because of this you will be asked to wear earplugs. You will receive a squeeze ball alarm in case you need urgent help. We will be able to talk with you and hear you during the MRI exam. The entire MRI scan will last about 45-60 minutes. The MR exam will include standard clinical images as well as the CSF flow imaging."
15842955|NCT04099810|Diagnostic Test|three-dimensional echocardiography|"A focused echocardiographic exam will be performed. In details will be acquired:
~high frame rate imaging clips acquired in a static position with attention to endocardial border optimization, minimum of 3 beats recorded with 'Acquire 2', of: a. Left ventricle 2c/3c/4c; b. left ventricle SAB, SAX-M, SAX-A; c. right ventricular focused apical view.
~Full volumes: a. 3d left ventricular apical acquisition; b. right ventricular apical acquisition; c. subcostal right ventricular acquisition."
15842956|NCT04099797|Genetic|(C7R)-GD2.CART cells|"Dose Level 0: 1 x 10^7 GD2.CART cells single transduced without C7R with lymphodepletion chemotherapy
~Dose Level 1: 1 x 10^7 C7R-GD2.CART cells with lymphodepletion chemotherapy
~Dose Level 2: 3 x 10^7 C7R-GD2.CART cells with lymphodepletion chemotherapy
~Dose Level 3: 1 x 10^8 C7R-GD2.CART cells with lymphodepletion chemotherapy"
15842957|NCT04099797|Drug|Cyclophosphamide|Patients at all dose levels will receive lymphodepletion chemotherapy. They will receive 2 daily doses of cyclophosphamide (500mg/m2/day) finishing at least 24 hours before T-cell infusion. The drug will be given intravenously (through an IV needle).
15842958|NCT04099797|Drug|Fludarabine|Patients at all dose levels will receive lymphodepletion chemotherapy. They will receive 3 daily doses of fludarabine (30mg/m2/day) finishing at least 24 hours before T-cell infusion. The drug will be given intravenously (through an IV needle).
15842959|NCT04099784|Other|Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3|Ages & Stages Questionnaires®, Third Edition (ASQ®-3) is a developmental screening tool designed for use by early educators and health care professionals. It relies on parents as experts, is easy-to-use, family-friendly and creates the snapshot needed to catch delays and celebrate milestones.
15842960|NCT04099784|Other|Physical development and General Health|Physical development and General health examination
15842961|NCT04099784|Other|Developmental Red flags|Developmental Red flags Questionnaires
15842962|NCT04099771|Drug|Ketamine|Ketamine infusion
15842963|NCT04099758|Behavioral|Mindfulness of the breath meditation|A 10-minute mindfulness of the breath meditation practice
15842964|NCT04099758|Behavioral|Audio-recording control|10 minute non-fiction audio-recording delivered online
15842965|NCT04099745|Device|CGM|Continuous Glucose Monitoring System
15842966|NCT04099745|Device|FGM|Flash glucose monitoring System
15842967|NCT04099732|Drug|Rosuvastatin|Tablet
15842968|NCT04099732|Drug|BI 1358894|Tablet
15842969|NCT04099732|Device|Dabigatran etexilate|Capsule
15842970|NCT04099706|Procedure|Autologous Fat Grafting / Fat Transplant|See arm descriptions.
15842971|NCT04099680|Procedure|Partial thickness recipient bed|Flap will be separated by sharp dissection and elevated toward apical direction, leaving the periosteum covering the bone, and the elevated pedicle flap will be incised and removed.
15842972|NCT04099680|Procedure|Full thickness recipient bed|Full-thickness (mucoperiosteal) flap will be raised on the recipient bed to establish a denuded bone area. Two bone screws will be placed at the most apical border of the denuded bone.
15842973|NCT04099680|Device|Bone screw (FDA approved bone screw)|Two bone screws placed at the most apical border of the denuded bone after osteotomy.
15842974|NCT04099680|Procedure|Periosteal sutures|Interrupted periosteal sutures placed at the 4 corners of each graft, and mesial and distal surfaces to engage the graft at an equidistance from the graft corners.
15842975|NCT04099680|Procedure|Sling sutures|Crossed sling sutures placed over the graft engaging the fixed crestal/lingual KT coronally and the periosteum apically.
15842976|NCT04099680|Procedure|Sling sutures around screws|Crossed sling sutures placed over the graft engaging the fixed crestal/lingual KT coronally and each is apically looped around the corresponding apically positioned screw.
15842977|NCT04099667|Drug|rimabotulinumtoxinB|IM injection on Day 1
15842978|NCT04099667|Drug|Placebo|IM injection on Day 1
15842979|NCT04099654|Other|Core-Stabilization Exercise|A program consisting of core stabilization exercises and physical activity counseling accompanied by physiotherapists will be applied to the study group.
15842980|NCT04099654|Other|Counseling of physical activity|Only physical activity counseling will be given to the subjects in this group.
15842981|NCT04099641|Drug|Bavituximab|Bavituximab IV infusion
15842982|NCT04099641|Drug|Pembrolizumab Injection|Pembrolizumab IV Infusion
15842983|NCT04099628|Diagnostic Test|Rapid diagnostic test (RDT); Serological and molecular tests on DBS|"The population of low to zero prevalence HAT foci will be actively screened for HAT by taking a blood sample for performing 3 rapid diagnostic tests (RDT) and for preparing dried blood spots to perform 4 serological and molecular high throughput reference tests. If at least one of the RDTs, serological or molecular reference tests is positive, parasitological examination is performed twice. The combined results of parasitological examinations serve as reference standard.
~Other Names:
~rHAT Sero-Strip (Coris Bioconcept, Belgium) SD Bioline HAT 1.0 (Standard Diagnostics Korea) HAT Sero-K-Set (Coris Bioconcept, Belgium) Immune trypanolysis: presence of antibodies ELISA: on native LiTat 1.3 + LiTat 1.5 variant surface glycoprotein (VSG) LAMP T. brucei Detection Kit (Eiken) RT-PCR: Trypanozoon 18S, Tbg Trypanosoma gambiense specific glycoprotein (TgsGP)"
15842984|NCT04099615|Procedure|Somatosensory Evoked Potentials|We stimulate both median nerves at wrist by means of surface adhesive electrodes. We apply square wave electrical pulses of 0.2 ms duration at a frequency of 5.7Hz. SEPs are recorded in a referential fashion from the C3' and C4' positions and from a reference electrode at Fpz or Cz' electrodes(international 10-20 system) with needle electrodes. The target signal is the presence of N20 response ipsilateral to the stroke site and, if present, measure amplitude and latency comparing with the contralateral if present. SEPs are registered during the whole procedure.
15842985|NCT04099602|Other|Baby Massage|Received baby massage and bilirubin levels were measured twice daily by the transcutaneous bilirubin meter for 5 days
15842986|NCT04099589|Drug|Toripalimab|Gemcitabine/Cisplatin plus Toripalimab
15843006|NCT04099407|Other|Standard of care|All participants will require to adhere to a standard of care including nutritional support, quarterly medical evaluation to review lab results and adjust medications, bi-annual Fibrotest, FibroScan and liver ultrasound, and annual upper-gastrointestinal endoscopy.
15843007|NCT04099394|Behavioral|Behavioral Health|Ten, group-based classes lasting one hour each that teaches symptom management and promotes physical activity.
15843163|NCT04097938|Drug|Placebos|Placebo oral suspension
15843164|NCT04097938|Drug|GLPG3667 capsules|GLPG3667 capsules
15842987|NCT04099576|Other|physiotherapy and education|Hot-pack, ultrasound, trancutaneus nerve electrical stimulation (TENS) and home program exercises were applied or given to the individuals within the physiotherapy program. In addition to physiotherapy, therapeutic neuroscience education were applied to experimental group. One-to-one speech sessions focusing on pain neurophysiology were organized twice a week for three weeks. Each session lasted 40 minutes. The Therapeutic neuroscience education program included nociception, ion channel neurophysiology, central and peripheral sensitization, methods to help reduce sensitization, neuroplasticity, psychosocial factors involved in the transition from acute pain to chronic pain and behavioral, cognitive responses to pain.
15842988|NCT04099576|Other|Physiotherapy alone|Hot-pack, ultrasound, trancutaneus nerve electrical stimulation (TENS) and home program exercises were applied or given to the individuals within the physiotherapy program.
15842989|NCT04099563|Drug|PF-04965842|"For this study, the investigational product is PF-04965842 (provided as 100 mg tablet).
~PF-04965842 100 mg tablets will be provided by Pfizer. Investigational product will be presented to the participants in individual dosing containers"
15842990|NCT04099550|Device|RT-CGM|The group was monitored blood glucose initial 1-week with a RT-CGM.
15842991|NCT04099550|Other|SMBG|The group was monitored self-monitoring blood glucose (SMBG) at least 2 times a day for initial 1-week.
15842992|NCT04099537|Behavioral|Computerized cognitive training|Participants are trained to approach or avoid stimuli of skin using a joystick. Participants are to pull or push the joystick toward or away when skin stimuli are present. Thus, behaviorally, there may be an increase, decrease, or no change in approach tendencies towards skin.
15842993|NCT04099524|Device|tDCS|tDCS (LPG/C3-anode, orbitofrontal cortex/Fp2-cathode) will be administered for 4 weeks (1 session per weekday for 2 weeks, and then 2 sessions per week for 2 weeks, for a total of 14 sessions). All subjects will receive anodal tDCS stimulation for 20 minutes per session, on C3 and the cathode electrode on Fp2 using 10/20 EEG system. tDCS will be applied with a pair of 35 cm2 single-use sponges soaked in approximately 4mL of saline solution on each side (~8mL per sponge) connected to the stimulator. During the 20-minute tDCS session, we will use online tDCS design (i.e., a subject will simultaneously work on the visual attention-oriented task.
15842994|NCT04099511|Behavioral|Usual Care Occupational Therapy-Outpatient|The control group in the proposed study will receive usual care occupational therapy services. The dosage between the experimental group and usual care will be identical with each group receiving ten 45- minute treatment sessions. The treating therapists will be unfamiliar with the experimental group intervention to avoid contamination. Each therapist will be instructed to provide care in the same manner as they typically provide in day-to-day practice for patients with similar characteristics as those in the study. The therapists will be encouraged to provide home action plans to participants. Usual care services will be monitored through a log of number of sessions, time spent in each session, and what activities were the focus of each session. The therapists will be instructed that they can address any participant goals they wish other than transfer goals identified by the participant.
15842995|NCT04099511|Behavioral|Cognitive Orientation to daily Occupational Performance|The Cognitive Orientation to daily Occupational Performance (CO-OP) approach was developed within the field of occupational therapy and is a performance-based, problem-solving approach to address activity performance limitations. Subjects will be taught to use the global problem-solving strategy of Goal-Plan-Do-Check: identifying a specific goal (Goal), outlining a practical plan for reaching that goal (Plan), accurately performing the plan (Do), and analyzing whether the plan led to achievement of the goal and altering the plan accordingly (Check). The Goal-Plan-Do-Check process will be iteratively applied to each of the activity goals. Therapists will use guided discovery to allow the subject to self-identify their own potential solutions within an activity (develop the plan). The therapists will be instructed that they can address any participant goals they wish other than transfer goals identified by the participant.
15842996|NCT04099498|Behavioral|Online Program: Healthy Eating Promotion with Self-regulation|Online-Intervention group
15842997|NCT04099498|Behavioral|Enhanced Online Program: Healthy Eating Promotion with Self-regulation|Enhanced-online-Intervention Group
15842998|NCT04099485|Other|Electronic Health Record Best Practice Advisory|The AFDST is a decision support tool that is embedded in our electronic health record system. Currently, this is a passive tool that requires the clinician to launch the tool if an analysis is desired. The experimental arm of this study will add a best practice advisory (BPA) that will trigger when a clinician is in the medical record of an AF patient who might gain substantial benefit (survival and quality of life) if treatment were changed from the current anticoagulation plan, which might be no anticoagulant therapy.
15842999|NCT04099472|Behavioral|Delirium Education, Prevention, and Management|"Patients and families will have a choice of either watching a 6-minute video or reading an educational booklet with a competent research assistant on the signs of delirium, risk factors, and prevention and management strategies.
~Caregivers will practice identifying delirium with the Sour Seven questionnaire, using previously validated case vignettes of hypothetical ICU patients. Family members will also complete a daily checklist of non-pharmacological interventions (ie. orientation, mobility, and environmental cues).
~Delirium detection by family caregivers will be assessed by the Sour Seven Questionnaire and communicated to the bedside nurse."
15843000|NCT04099472|Behavioral|Standard Care|Patients and families will receive standard care, which is an informational pamphlet on ICU delirium upon admission.
15843001|NCT04099446|Other|Non-interventional|There is no intervention for this study
15843002|NCT04099433|Dietary Supplement|Vivomixx|Individuals in the interventional arm will undergo daily oral intake of probiotic supplement
15843003|NCT04099433|Other|Placebo|Individuals in the placebo arm will undergo daily oral intake of placebo supplement
15843004|NCT04099420|Behavioral|Lifestyle counseling|An in-depth analysis of the lifestyle of Italian and Spanish university students will be carried out for the first time, with assessment of the frequency of self-medication and use of drugs and supplements/nutraceuticals. The composition of the oral microbiota in relation to eating habits will be determined for the first time. The results of this study will be useful for designing promotion programs for the correct use of drugs/supplements and for healthy diets and lifestyles in university students
15843005|NCT04099407|Drug|Pirfenidone|Treatment consist of 600 mg tablets of a prolonged-released formulation of Pirfenidone. Patients are instructed to take medication orally, every 12 h, after breakfast and dinner.
15843043|NCT04099082|Other|samples|blood sample nasal swab
15843008|NCT04099394|Behavioral|Health Education|Ten, group-based classes lasting one hour each that teaches topics related to aging and health (e.g., blood pressure control, maintaining healthy bones, cancer screening, immunizations).
15843009|NCT04099381|Biological|ASD CB-MNC infusion low level HLA compatibility.|CB-MNC infusion from different donors. One dose consists of 2-15х10^7 cells per 1 kg of patient weight for each infusion. The protocol includes 2 infusions with an interval of 6-x months. HLA compatibility of the cord blood is 3 or fewer by A, B, DRB1 loci.
15843010|NCT04099381|Biological|ASD CB-MNC infusion high level HLA compatibility.|CB-MNC infusion from different donors. One dose consists of 2-15х10^7 cells per 1 kg of patient weight for each infusion. The protocol includes 2 infusions with an interval of 6-x months. HLA compatibility of the cord blood is 4 or more by A, B, DRB1 loci.
15843011|NCT04099381|Other|Standard therapy.|The standard therapy can include drugs, special psychology training etc.
15843012|NCT04099368|Behavioral|Musical pitch training|Crossover design with one group receiving musical training as rehabilitation, second group receiving visual training first as a control rehabilitation.
15843015|NCT04099342|Device|FEAST|FEAST with standard electrode configuration and current flow
15843016|NCT04099342|Device|FEAST RP|FEAST with standard electrode configuration and reversed current flow
15843017|NCT04099342|Device|FEAST RC|FEAST with standard current flow and reversed electrode configuration
15843018|NCT04099329|Behavioral|Pre-game Safety Huddles|Coaches will be trained to lead Pre-game Safety Huddles by the RA with the study using a multi-media tool we have developed. Huddles will be brief (1-2 minutes) and will primarily focused on 1) encouraging concussion reporting and 2) encouraging good sportsmanship
15843019|NCT04099316|Device|Eccentric exercise|Eccentric exercise with Eccentron electronic device. Exercise intervention: The exercise intervention is performed to twice a week (Total 8 weeks). Exercise intensity is gradually increased to the number of times by divided into two stages (1-4 weeks; 1st stage),(5-8 weeks; 2nd stage).
15843020|NCT04099316|Device|Conventional resistance exercise|Leg press exercise with leg press machine. Exercise intervention: The exercise intervention is performed to twice a week (total 8 weeks). Exercise intensity is gradually increased to the number of times by divided into two stages (1-4 weeks; 1st stage), (5-8 weeks; 2nd stage).
15843021|NCT04099303|Biological|Diphtheria,Tetanus and Acellular Pertussis (Three Components) Combined Vaccine, Adsorbed|0.5 mL, Intramuscular Other Name: DTcP
15843022|NCT04099303|Biological|Diphtheria and Tetanus Combined Vaccine, Adsorbed|2mL, Intramuscular Other Name: DT
15843023|NCT04099303|Biological|Diphtheria-tetanus-acellular pertussis vaccine|0.5 mL, Intramuscular Other Name: DTaP
15843024|NCT04099303|Biological|Diphtheria,tetanus,pertussis(acellular,component),poliomyelitis(inactivated) vaccine(absorbed) and Haemophilus influenzae type b conjugate vaccine|0.5 mL, Intramuscular Other Name: PENTAXIM
15843026|NCT04099277|Drug|LY3435151|Administered IV
15843027|NCT04099277|Drug|Pembrolizumab|Administered IV
15843028|NCT04099264|Other|Personalized music|Patients in the intervention group will listen to personalized music from the Musicare application
15843029|NCT04099264|Other|Audio Books|Patients in the active comparator group will listen to audio books
15843030|NCT04099251|Biological|Nivolumab|Specified dose on specified days
15843031|NCT04099251|Other|Placebo|Specified dose on specified days
15843032|NCT04099238|Drug|Oral anticoagulant|Oral anticoagulants may comprise vitamin K antagonists (VKA) and non-vitamin K antagonist oral antagonists (NOAC).
15843033|NCT04099225|Diagnostic Test|Multiple breath washout (MBW) testing|Lung clearance index (LCI), acinar (Sacin) and conductive (Scond) ventilation heterogeneity were derived from triplicate SF6-MBW measurements. Global ventilation heterogeneity was calculated for the 2.5% (LCI2.5) and 5% (LCI5) stopping points.
15843034|NCT04099199|Diagnostic Test|Click Sexual Health Test|The Click Diagnostics device is a single-use (disposable), fully integrated, rapid, compact, device containing a polymerase chain reaction (PCR)-based nucleic acid amplification test (NAAT) for accurate, qualitative detection and differentiation of deoxyribonucleic acid (DNA) for Neisseria gonorrhea (NG), Trichomonas vaginalis (TV), and Chlamydia trachomatis (CT) organisms.
15843035|NCT04099186|Procedure|catheter directed hydro-mechanical fragmentation of pulmonary embolism|A(6)F multipurpose catheter will be advanced over a guide wire under fluoroscopic guidance and used to measure right heart and pulmonary artery pressures, then mechanical catheter fragmentation will be done using a pigtail catheter. The catheter will be quickly spun manually so as to fragment the central thrombus and establish initial flow into pulmonary artery , then 200 ml saline will be injected via power injector to aid fragmentation of thrombus
15843036|NCT04099173|Behavioral|Brief Mindfulness Based Intervention|This intervention will consist of four, 45 minute individual mindfulness training sessions (one session per day, over a range of 12 subsequent days) provided by a trained mindfulness facilitator.
15843037|NCT04099160|Other|Evaluation|The Turkish version of the Revised Neurophysiology of Pain Questionnaire will be applied to patients with chronic spinal pain at the beginning of the study and a week later. The Visual Analogue Scale and the Short Form-36 (SF-36) questionnaire will be applied to patients only at the beginning of the stuy.
15843038|NCT04099147|Other|This is an observational study.|This is an observational study. No intervention is planned outside of usual clinical practice.
15843039|NCT04099121|Device|Ultrasound Imaging|3D ultrasound of the pelvic floor and vaginal cavity will be obtained by using a commercial ultrasound system.
15843040|NCT04099108|Combination Product|Combined cycle ergometry and bolus amino acid supplementation|A 4-hour bolus amino acid supplement administered within 30 minutes after a 30-minute in-bed cycling session.
15843041|NCT04099095|Behavioral|Immediate Appointment|The participant will meet the British Red Cross link worker and decide upon a course of action requiring the use of local services appropriate for the participant
15843042|NCT04099095|Behavioral|Delayed Appointment|After a period of delay (control) the participant will meet the British Red Cross link worker and decide upon a course of action requiring the use of local services appropriate for the participant
15843045|NCT04099056|Device|Transcranial Magnetic Stimulation (TMS)|Participants will be seated comfortably in a chair and asked to complete simple computer tasks. Either during, or just before any of the tasks, participants will receive either repetitive transcranial magnetic stimulation (rTMS) or single pulse TMS. During this, the researchers place a small plastic coil next to the participant's head. The coil will then generate a magnetic pulse, and stimulation will occur during presentation of the visual stimuli on which subjects will conduct behavioral or cognitive tasks.
15843046|NCT04099043|Device|Cascade Continuous Glucose Monitoring System|Continuous Glucose Monitoring for 15 days
15843047|NCT04099017|Other|Mulligan Joint mobilization|"This study ARM will received Mulligan joint mobilization and concomitant therapies in this group.
~The following are the brief detail of therapy
~Mulligan joint mobilization in Non-weight bearing (NWB) to weight-bearing (WB) 6 -10 Reps and 3 sets/ session.
~Procedural detail:
~Joint mobilization will be performed in sagittal, frontal and transverse direction, following glide will be preferred will depend on patient adherence to the joint mobilization. Mobilization will be progress from NWB to WB according to patient compliance 27
~Knee strengthening Type of exercise: Knee Isometric Strengthening exercises. Intensity: 10 reps Frequency: At 1st week one set of all knee exercise will be performed then it will be progressed to 2 sets at 3 weeks, and these exercises will be progressed to three sets until the 6 weeks
~Kinesiotaping:"
15843048|NCT04099017|Other|Trunk stabilization group|"This study ARM will received Trunk stabilization exercises and concomitant therapies in this group.
~The following are the brief detail of therapy:
~Trunk stabilization Area: Trunk Type of exercise: Stabilization exercise Intensity: 6-8 reps Frequency: 3 sets per session and 30 second duration break between sets
~Procedural detail:
~i. modified supermen extension exercise ii. Back bridge: iii. Unilateral back bridge:
~Iv. lateral step up:
~Knee strengthening Area: Knee Joint Type of exercise: Knee Isometric Strengthening exercises. Intensity: 10 reps Frequency: At 1st week one set of all knee exercise will be performed then it will be progressed to 2 sets at 3 weeks, and these exercises will be progressed to three sets until the 6 weeks
~Procedural detail:
~i. Isometric quadriceps exercise: ii. Straight leg raising (SLR) exercise:
~Kinesiotaping:"
15843049|NCT04099017|Other|Knee strengthening group|"This study ARM will received Knee strengthening exercises and concomitant therapies in this group.
~The following are the brief detail of therapy:
~Knee strengthening Area: Knee Joint Type of exercise: Knee Isometric Strengthening exercises. Intensity: 10 reps Frequency: At 1st week one set of all knee exercise will be performed then it will be progressed to 2 sets at 3 weeks, and these exercises will be progressed to three sets until the 6 weeks
~Procedural detail:
~i. Isometric quadriceps exercise ii. Straight leg raising (SLR) exercise:
~Kinesio-taping:
~Muscle stretch method will be applied which involves one Y and two I straps: The Y-shaped tape base will be affixed over the top of patella then pulls up his/her knee to its maximum bending capacity then both end of Y strip is placed around the patella ending on the tibial tuberosity. Then reinforcing I-tape will be affixed at the origin and insertion of MCL and LCL. Tape will be change in every session."
15843050|NCT04098991|Drug|Levothyroxine|All participants will be treated for their hypothyroidism according to the standard of care as reflected in recent guidelines from the American Thyroid Association.
15843051|NCT04098978|Other|Pharmacist Drug Therapy Management|Patients will be seen by pharmacist for collaborative drug therapy management.
15843052|NCT04098965|Other|Pysiotherapy techniques|manual therapy techniques, postural re-education and muscle strengthening
15843053|NCT04098965|Other|physician treatment|hygienic-dietary recommendations, Kegel exercises and pain relievers
15843054|NCT04098952|Other|Control group|The treatment techniques used will be: ischemic compression in the trigger point of the masseter and myofascial technique for the decompression of the temporals.
15843055|NCT04098952|Other|Experimental group|In addition to the treatment techniques applied to the other group, an electric massage will be performed with interferential currents at the level of the cervical region.
15843056|NCT04098939|Diagnostic Test|Diaphragm evaluation|Ultrasound and radiographic evaluation of diaphragm function
15843057|NCT04098926|Radiation|Dose-integrated accelerated EBRT in pN0 breast cancer|WBI: 5 x 5.7Gy Thoracic wall: 5 x 5.7Gy R0 boost: 5 x 6.5Gy R1 boost: 5 x 6.9Gy
15843058|NCT04098926|Radiation|Dose-integrated accelerated EBRT in pN+ breast cancer|WBI: 5 x 5.7Gy Thoracic wall: 5 x 5.7Gy R0 boost: 5 x 6.5Gy R1 boost: 5 x 6.9Gy Lymph node region: 5 x 5.4Gy
15843059|NCT04098913|Behavioral|Reduced screen-based media use|Participants must remove all recreational screen-based media use beyond 3 hours/week. This includes all recreational screen-based media use inside and outside the household. As a tool to comply with the intervention the families will hand-over all portable screen-based media devices. In return, each participant who own a smartphone will receive a regular cell-phone which can only make phone calls and send text messages. For a maximum of ½ an hour a day, adult participants may use screen-based media for necessary contact/errands. If one of the adult participants can not hand over their smartphones due to daily use for work purposes we will install an app tracking screen use on these devices.
15843060|NCT04098900|Diagnostic Test|Click Sexual Health Test|The Click Device is a single-use (disposable), fully integrated, rapid, compact, device containing a polymerase chain reaction (PCR)-based nucleic acid amplification test (NAAT) for accurate, qualitative detection and differentiation of deoxyribonucleic acid (DNA) for Neisseria gonorrhea (NG), Trichomonas vaginalis (TV), and Chlamydia trachomatis (CT) organisms.
15843061|NCT04098887|Radiation|Lattice stereotactic body radiation therapy|For Lattice SBRT, the daily prescription dose will be 20 Gy to be delivered to the PTV_2000 with a simultaneous integrated boost of 66.7 Gy to be delivered to the PTV_6670 over 5 fractions (4 Gy and 13.2 Gy to the PTV_2000 and PTV_6670, respectively).
15843062|NCT04098874|Drug|Bupropion Extended Release Oral Tablet|12 weeks postpartum of blinded study medication
15843063|NCT04098874|Drug|Placebo oral tablet|12 weeks postpartum of blinded placebo
15843064|NCT04098861|Drug|Latanoprost/Timolol|Latanoprost/Timolol Fixed Combination
15843065|NCT04098848|Other|Cycling exercise|Intradialytic cycling exercise for 30 minutes a time
15843066|NCT04098835|Behavioral|ASCEND|ASCEND is a behavioral intervention that combines computer-based cognitive exercise, strategy coaching with a neuropsychologist, and homework exercises in order to improve attention, working memory, and cognitive control after stroke.
15843165|NCT04097925|Drug|Doravirine|Doravirine 100 mg tablet
15843166|NCT04097925|Drug|Descovy|Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet
15843167|NCT04097912|Drug|Acetylsalicylic Acid (Aspirin, BAYE4465)|75-100mg
15843067|NCT04098822|Device|Virtue male sling|The Coloplast Virtue® Male Sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male SUI resulting from in-trinsic sphincter deficiency (ISD). The sling is manufactured from polypropylene and is sold for single use only. The device is a quadratic sling and consists of a knitted monofilament polypropylene mesh. The body of the device provides surface area for supporting the bulbous urethra.
15843068|NCT04098809|Device|16 French urinary catheter|16 French urinary catheter
15843069|NCT04098809|Device|20 French urinary catheter|20 French urinary catheter
15843070|NCT04098796|Drug|Anti-PD-1 antibody|Sintilimab will be administered 200 mg intravenous drip, every 3 weeks. Anti-PD-1 antibody will be administered until the disease progresses or lasts for two years.
15843071|NCT04098796|Drug|XELOX|Oxaliplatin 130 mg/m2, intravenous drip, d 1; Capecitabine 1000mg/ kg, twice a day, orally, d1-14; Every 21 days. XELOX 6-8cycles，followed by capecitabine monotherapy, the course of treatment is determined by the investigators according to clinical practice.
15843072|NCT04098783|Other|Home visit, health education|
15843073|NCT04098770|Biological|Allogeneic Adoptive Immune Therapy|A dose (2-3 times) of AAIT was added on conventional treatment for advanced AIDS patients
15843074|NCT04098757|Dietary Supplement|Migratens|2 sachets/day: 800 mg of α-Lipoic acid, 450 mg of magnesium bisglycinate, 300 mg of L-Tryptophan, 20 mcg of Vitamin D3, 2.4 mg of Vitamin B2, 25 mg of Niacin, 150 mg of Coenzyme Q10. Patients who receive Migratens food supplementation have to take 2 sachets / day for 12 weeks. The supplement will be prescribed as usual and the assumption of the same will be recorded by partecipants in the appropriate daily; if the subject does not continue the indication the data collected up to that moment will be considered.
15843075|NCT04098744|Drug|Artesunate vaginal insert|Artesunate formulated as vaginal inserts, 200mg
15843076|NCT04098744|Drug|Placebo vaginal insert|Placebo for artesunate vaginal inserts
15843077|NCT04098718|Drug|Benralizumab|100mg sub cut once only
15843078|NCT04098718|Drug|Prednisolone|30mg tablet daily for 5 days
15843079|NCT04098705|Other|Introduction of the World Health Organization Triage Scale|"The intervention will comprise implementation of a new triage and patient flow system facilitated through staff training and clinical redesign.
~The three-tier World Health Organization Triage Scale (WHOTS) will be used as the triage instrument. This tool, developed collaboratively by the WHO, International Committee of the Red Cross (ICRC) and Médecins Sans Frontières (MSF), incorporates features of the South African Triage Scale but has been modified for application in a wide variety of RL settings. WHOTS documents are provided in the research protocol."
15843080|NCT04098692|Drug|Derazantinib capsule|300 mg derazantinib oral administration (3x100 mg capsules)
15843081|NCT04098692|Drug|[14C]-Derazantinib solution for infusion|100 μg [14C]-derazantinib intravenous administration
15843082|NCT04098692|Drug|[14C]-Derazantinib capsule|300 mg [14C]-derazantinib oral administration (3x100 mg capsules)
15843083|NCT04098666|Drug|Placebo oral tablet|Placebo tablet identical to metformin, up to 4 tablets a day
15843084|NCT04098666|Drug|extended release metformin|Metformin extended release 500 mg tablets, up to 4 tablets a day
15843085|NCT04098653|Drug|Decitabine|Decitabine was administered at 20mg/m2/day on days -14 and -10.
15843086|NCT04098653|Drug|Busulfan (BU)|Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.
15843087|NCT04098653|Drug|Cyclophosphamide (CY)|Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
15843088|NCT04098640|Genetic|FoundationOne CDx|FoundationOne CDx will be performed using archival tumor tissue
15843089|NCT04098627|Behavioral|Laughter Therapy|Once weekly 30-minute long group laughter therapy session for 8 weeks
15843090|NCT04098614|Behavioral|Recovery Coach Intervention|Participants randomized to the intervention arm are linked to a recovery peer coach while they are in the hospital. Recovery peer coaches are provided to the participant by Faces and Voices of Recovery (FAVOR) - Greenville. Recovery coaches are Certified Peer Support Specialists (CPSS), individuals who have firsthand experience in successful recovery and are trained in using recovery-oriented tools to help peers overcome addiction. FAVOR offers immediate access to a personal coach, a local center, and assistance to off-site intervention and recovery resources in the community. They provide twice weekly contact with participants.
15843091|NCT04098601|Behavioral|Recovery Coach Intervention|Participants randomized to the intervention arm are linked to a recovery peer coach while they are in the hospital. Recovery peer coaches are provided to the participant by Faces and Voices of Recovery (FAVOR) - Greenville. Recovery coaches are Certified Peer Support Specialists (CPSS), individuals who have firsthand experience in successful recovery and are trained in using recovery-oriented tools to help peers overcome addiction. FAVOR offers immediate access to a personal coach, a local center, and assistance to off-site intervention and recovery resources in the community. They provide twice weekly contact with participants.
15843092|NCT04098588|Behavioral|BEAST|See Arm Description
15843093|NCT04098588|Behavioral|Descriptive Feedback|See Arm Description
15843094|NCT04098575|Drug|Empagliflozin|drug
15843095|NCT04098562|Drug|LL37|cream
15843096|NCT04098562|Procedure|Standard Wound Care|Standard wound debridement
15843097|NCT04098549|Other|Rapid lowering of plasma glucose|Rapid lowering of plasma glucose using hypoglycemic clamp technique
15843098|NCT04098549|Other|Slow lowering of plasma glucose|Slow lowering of plasma glucose using hypoglycemic clamp technique
15843099|NCT04098536|Behavioral|Diesel exhaust|Exposure to diesel exhaust fumes
15843100|NCT04098523|Diagnostic Test|Duplex ultrasound|A one-time carotis and abdominal aorta duplex ultrasound will be performed on-site by a skilled site staff to determine the prevalence of, and risk factors associated with, CAS and AAA. A diameter measurement will be performed of the abdominal aorta as well as a determination of the carotid arteries.
15843101|NCT04098510|Dietary Supplement|MitoQ|Subjects ingest 8x20 mg MitoQ capsules
15843130|NCT04098276|Behavioral|WeWomen Plus technology based intervention|The WeWomen Plus intervention is a technology based (online, text and phone)culturally tailored intervention designed to reduce the risk of future intimate partner violence or a homicide, improve mental health and increase empowerment of abused immigrant women.
15843131|NCT04098263|Biological|LMN-101|variable heavy chain-derived binding protein designed to bind and inhibit flagellin filament protein of Campylobacter jejuni, delivered in whole spray-dried, encapsulated spirulina biomass
15843102|NCT04098497|Behavioral|Mobile intervention|"The mobile intervention in this study consists of two components: 1) self-monitoring and 2) an ACT-based microintervention.
~Self-monitoring: twice daily, participants will complete self-reports of mania, depression, medication adherence, and activity through the mobile app Lorevimo.
~Microintervention: The microintervention will consist of one of 84 prompts that aim to target one of 6 processes targeted in ACT (contacting the present moment, defusion, acceptance, self-as-context, values, and committed action). At each time-point, participants have a 50% chance of receiving a microintervention question along with the daily self-monitoring assessments."
15843103|NCT04098484|Other|Control Trial|Participants will abstain from exercise throughout a 3-month period
15843104|NCT04098484|Other|Exercise Trial|Participants will execute a 3-month exercise training program
15843105|NCT04098471|Procedure|transanal local excision following radiotherapy|transanal local excision following radiotherapy
15843106|NCT04098458|Behavioral|NDURE|NDURE consists of 6 key functions including (1) Improve patient knowledge about guidelines for timely PORT and associated care processes; (2) Minimize the burden of travel for HNSCC care; (3) Improve communication between patients and providers regarding intentions and goals for timely, guideline-adherent PORT; (4) Enhance coordination of care between healthcare teams during care transitions and about treatment sequelae; (5) Track referrals to ensure timely scheduling of appointments and patient attendance across fragmented healthcare systems; (6) Restructure the organization to clarify roles and responsibilities for care processes associated with PORT delivery to avoid duplication and gaps in care. Direct contact between the NDURE navigator and patient occurs via three clinic-based, face-to-face NDURE sessions lasting 30-60 minutes each at the pre-surgical consult, hospital discharge, and first postoperative visit.
15843107|NCT04098432|Drug|Nivolumab|Nivolumab 3 mg/kg intravenously every two weeks untill disease progression or unacceptable toxicity
15843108|NCT04098432|Radiation|Stereotactic radiotherapy|The prescribed dose will be 32 Gy in four fractions in four weeks (8 Gy per one fraction).
15843109|NCT04098419|Behavioral|Science for Life|The implementation for both school years will follow the same procedures with different cohorts. Sixteen adolescents will be recruited through existing after-school programs at each location (32 total each year). College interns will facilitate food literacy lessons after school once per week with high school-aged adolescents. Beginning in January, adolescents will participate in training led by project staff and college interns to become competent cross-age teachers for garden-enhanced nutrition curricula. This training will consist of instruction in utilization of inquiry-based teaching practices and will be followed by adolescents practicing facilitating the curricula in teaching pairs. Up to 32 younger youth participants at each location (up to 64 total each year) will be recruited from local elementary schools while adolescents complete the cross-age teaching training. With mentorship from college interns, adolescents will facilitate curricula in pairs with younger youth.
15843110|NCT04098406|Drug|CNM-Au8|CNM-Au8 is a dark red/purple-colored liquid formulation consisting of a stable suspension of faceted clean surfaced elemental gold nanocrystals in buffered deionized water with a nominal concentration of 0.5 mg/mL of gold. The formulation is buffered by sodium bicarbonate present at a concentration of 0.546 mg/mL. There are no other excipients. The drug product is formulated to be taken orally and will be provided in single dose 60 mL HDPE containers.
15843111|NCT04098406|Drug|Placebo|Placebo is liquid with identical color and taste
15843112|NCT04098393|Drug|Busulfan 3.2 mg/kg/day|Busulfan 3.2 mg/kg/day, with dose adjustments made according to pharmacokinetic (PK) levels.
15843113|NCT04098393|Drug|Fludarabine|Fludarabine (25mg/m2/ day) administered on days -6, -5, -4, -3, and -2.
15843114|NCT04098393|Drug|Melphalan|Melphalan (70mg/m2/day) administered on days -6 and -5.
15843115|NCT04098393|Drug|Antithymocyte globulin (ATG)|ATG will be given based on a dynamic nomogram based on the patient's absolute lymphocyte count at the start of conditioning and can result in 2 or 3 days of ATG administration.
15843116|NCT04098393|Drug|Busulfan 0.8 mg/kg|Busulfan 0.8 mg/kg every 6 hours x 10 doses, with dose adjustments made according to PK levels.
15843117|NCT04098393|Procedure|Allogeneic hematopoietic cell transplantation (Allo-HCT)|Allogeneic hematopoietic cell transplantation following the conditioning regimen.
15843118|NCT04098380|Procedure|Small Bite|the bites will be applied with a bite width of 5 mm and inter-suture spacing of 5 mm
15843119|NCT04098380|Procedure|Larger bite|the bites will be applied with a width of 10 mm and inter-suture spacing of 10 mm
15843120|NCT04098367|Device|VIVITY|Extended vision intraocular lens intended for primary implantation for the visual correction of aphakia in adult patients with less than 1.00 diopter of preoperative corneal astigmatism in whom a cataractous lens has been removed by extracapsular cataract extraction.
15843121|NCT04098367|Device|SYMFONY|Extended range of vision intraocular lens indicated for primary implantation for the visual correction of aphakia in adult patients with less than 1.0 diopter of pre-existing corneal astigmatism in whom a cataractous lens has been removed.
15843122|NCT04098367|Device|AT LARA|Extended depth of focus intraocular lens indicated for implantation for the visual correction of aphakia in patients with and without presbyopia in whom a cataractous lens has been removed by extracapsular cataract extraction.
15843123|NCT04098354|Diagnostic Test|home BP telemonitoring system .|home BP telemonitoring system whereby a patient pushes a single button on a home BP monitor to initiate measurement, and data are auto-transmitted via Bluetooth to an Android smartphone and relayed to a secured web portal for review.
15843124|NCT04098341|Diagnostic Test|IGRA blood test used as a tool for opt-out screening for latent Tuberculsis infection|All eligible pregnant migrants will be offered an opt-out screening IGRA blood test for latent Tuberculosis infection
15843125|NCT04098315|Other|REGISTER CREATION|Build a national registry of patients with HIV-1 infection and documented resistance to the 4 classes of antiretroviral drugs.
15843126|NCT04098302|Drug|Dutasteride Capsules|1 mg/day oral dutasteride (2 x 0.5 mg capsules)
15843127|NCT04098302|Drug|Placebo Capsules|Placebo capsules with matching appearance as Dutasteride Capsules
15843128|NCT04098289|Procedure|Hysteroscopic septum resection|Hysteroscopic septum resection, using a 26 French continuous-flow resectoscope with monopolar energy and electrolyte-free distension medium.
15843129|NCT04098289|Procedure|In vitro fertilization|Fertilization of oocytes with the spermatozoa of the partner, after induction of ovulation and capacitation of the sperm, using fertilization in vitro and embryo transfer (FIVET) or intracytoplasmic sperm injection (ICSI).
15843136|NCT04098185|Device|CT|Non-contrast Multidetector Computed Tomography will be done for all patients using 16 or 64 MDCT scanner. Standard scanning parameters of chest CT are used with slice thickness 5 mm, 120kv and automated mAs.The evaluation of pleural effusion attenuation will be done using the average measure of 3 slices with greatest amount of fluid. A region of interest (ROI) is placed for measurement of Hounsfield unit values, where pleural fluid is observed to be most intense and the density values of the pleural fluid and of the aorta are quantitatively measured in the same section with taking care not to involve adjacent ribs, lung parenchyma or areas of pleural thickening.
15843137|NCT04098172|Device|Pressure Guidewire|Fractional Flow Reserve measurement
15843138|NCT04098159|Device|duplex ultrasound|regular duplex follow up every three months with subsequent intervention either diagnostic venography , angioplasty or surgery according to the type of the lesion
15843139|NCT04098146|Procedure|Surgical Resection and Reconstruction|"One stage reconstruction: Osseous reconstruction is performed in the same surgery of the tumor/mandibular resection. It is also known as immediate or primary reconstruction.
~Second stage reconstruction: Osseous reconstruction is performed after the tumor/mandibular resection surgery as an independent surgery. After the mandibular resection a temporary alloplastic bridging might be put in place. It is also known as delayed or secondary reconstruction."
15843140|NCT04098133|Other|data collection for demographic data|data collection for demographic data (age, gender, hospital admission and discharge date, length of stay, hospitalization prior to current hospital stay (acute care facilities, long-term healthcare centres, nursing homes), discharge destination, outcome, cause of death, travel history, previous exposure to antibiotics and proton pump Inhibitors)
15843141|NCT04098133|Other|data collection for clinical data|data collection for clinical data (comorbidities, Charlson Comorbidity Index, immunosuppressive treatment, date of diagnosis of CPB, days between hospital admission and diagnosis of CPB, type of consecutive infection, indwelling vascular hardware, urinary catheterization, surgical therapies)
15843142|NCT04098133|Other|data collection for treatment data|data collection for treatment data (antibiotic therapy, immunosuppressive therapy, concomitant medication)
15843143|NCT04098133|Other|data collection for microbiological data|data collection for microbiological data (species of CPB, type of sample, date of sample, history of colonization or infection with any antibiotic resistant pathogen)
15843144|NCT04098107|Device|Throwing Device|The Innovative Design Labs ( IDL) PhySens will be used to monitor the physical motions of subjects during standard sports-related actions (e.g. throwing a baseball). For this test, the PhySens Carrier will be attached via clothing rivets to a fabric sleeve or strap made of compliant materials commonly used in clothing and wearable products (e.g. nylon, spandex, neoprene).
15843145|NCT04098081|Drug|galeterone|Therapeutic
15843146|NCT04098081|Drug|Gemcitabine|Therapeutic
15843147|NCT04098068|Drug|MK-3475 (an Antibody That Blocks Negative Signals to T Cells)|MK-3475 (an Antibody That Blocks Negative Signals to T Cells) 200 mg/kg flat dose every 21 days
15843148|NCT04098055|Device|Custom-Made Foot Orthoses|The foot orthoses were custom made using phenolic foam molds of the feet. They consisted of a polypropylene layer of 2 mm from heel to just proximal to the metatarsal heads, an upper sheet of 30 Shore A polyethylene foam.
15843149|NCT04098055|Device|Placebo|The insole made using phenolic foam molds of the feet. They consisted of an upper sheet of 30 Shore A polyethylene foam.
15843150|NCT04098042|Device|Scaffold|implantation of a Magmaris scaffold
15843151|NCT04098029|Biological|Low HLA group CBU infusion|CB-MNC (Cord Blood Mononuclear Cells) infusion from different donors. One dose consists of 2-15х10^7 cells per 1 kg of patient weight for each infusion. The protocol includes 2 infusions with an interval of 6-x months. HLA compatibility of CB is 3 or fewer by A, B, DRB1 loci.
15843152|NCT04098029|Biological|High HLA group CBU infusion|CB-MNC (Cord Blood Mononuclear Cells) infusion from different donors. One dose consists of 2-15х10^7 cells per 1 kg of patient weight for each infusion. The protocol includes 2 infusions with an interval of 6-x months. HLA compatibility of CB is 4 or more by A, B, DRB1 loci.
15843153|NCT04098029|Other|Standard therapy|The standard therapy can include drugs, special psychology training, etc.
15843154|NCT04098016|Behavioral|Digital Intervention|Participants will receive: 1) tailored behavior change goals, 2) self-monitoring with tailored feedback, 3) skills training.
15843155|NCT04098003|Drug|Rosuvastatin|rosuvastatin 20 mg daily or placebo for eight weeks
15843156|NCT04098003|Drug|Placebo|Matched placebo control
15843157|NCT04097990|Other|blood sample|a 5 cc blood sample will be taken after a 12-hour fast for separation of triglycerides from the serum and for checking fatty acid levels
15843158|NCT04097977|Other|An educational support model called RENEW (Rehabilitation for Empowerment, Natural Support, Education and Work) targeting young people with mental health difficulties.|"An educational support model called RENEW (Rehabilitation for Empowerment, Natural Support, Education and Work).
~Intervention The RENEW-S intervention consists of two key elements: collaborative networking and a youth group.
~Network meetings The RENEW-S network meetings is fundamental for this approach. First meeting between the young person and the facilitator is about what the young person can expect, and information about the principles and ideas behind RENEW-S. The RENEW-S process consists of 4 general phases: 1) a mapping process 2) the development of a team to support goal attainment 3) implementing the plans 4) preparation for exiting RENEW.
~Youth group The group is structured around the same agenda each time, starting with a presentation round, followed by an activity within the topic of the day, and finishing with sharing experiences of the activity in plenum. The young people can find inspiration regarding themes and exercises in the RENEW manual."
15843161|NCT04097951|Drug|Combinations|Montelukast and Bepotastine Combination
15843162|NCT04097938|Drug|GLPG3667 oral suspension|GLPG3667 oral suspension
15843168|NCT04097899|Other|implementation of antimicrobial stewardship comprehensive care bundle program on ventilator associated pneumonia patients|"Construction of a comprehensive care bundle educational program. This program consisted of many elements: Antimicrobial stewardship programs, VAP bundles and infection control policy implementation and the investigators studied the impact of this program on:
~Antibiotics cost.
~Appropriates of antibiotic use (initiation, duration & time of discontinuation).
~Rate of resistance
~Clinical outcome, infection rate &length of stay."
15843169|NCT04097886|Other|Morning Exercise|moderate intensity exercise (70% VO2 max) each morning for 5 days
15843170|NCT04097886|Other|Evening Exercise|moderate intensity exercise (70% VO2 max) each evening for 5 days
15843171|NCT04097873|Other|Diaphragm ultrasonography reeducation plus inspiratory training|Diaphragm biofeedback reeducation plus inspiratory training during 6 weeks
15843172|NCT04097873|Other|Isolated inspiratory training|Isolated high-intensity inspiratory muscle training during 8 weeks
15843173|NCT04097860|Behavioral|Text message including biomarker of breast pumping adequacy|The intervention group will be sent one message that includes general information pertinent to all mothers expressing BM for their infants and one personalized real-time biomarker based message which will include the sodium level contained in the BM since the previous message, the number of times pumped on those days and will either congratulate the participant on how well the participant is pumping BM for the infant or how many more times per day the participant needs to pump to decrease the BM sodium level and increase BM production
15843174|NCT04097847|Drug|Pentoxifylline-Tocopherol-Clodronate|the aim of this retrospective study is to analyze from patient records the impact of the PENTOCLO protocol on maxillofacial osteoradionecrosis at Brest Hospital University, France.
15843175|NCT04097821|Drug|Ruxolitinib|5 mg tablets for oral use
15843176|NCT04097821|Drug|Siremadlin|10 mg, 20 mg, or 40 mg capsules for oral use
15843177|NCT04097821|Drug|Crizanlizumab|100 mg/mL concentrate for infusion for intravenous use
15843178|NCT04097821|Drug|Sabatolimab|100 mg/mL or 400 mg/4 mL concentrate for infusion for intravenous use
15843179|NCT04097821|Drug|LTT462|100 mg capsule for oral use
15843180|NCT04097821|Drug|NIS793|700 mg/7 mL concentrate for intravenous use
15843181|NCT04097808|Dietary Supplement|collagen peptides|Collagen peptides will be orally administered and pharmacokinetic parameters will be assessed up to 6 hours after study product intake.
15843182|NCT04097795|Other|Prehabilitation|According to our definition, prehabilitation consists of exercise therapy during at least 2 weeks. This is combined with optimalisation of the patients' nutritional status at least 2 weeks before surgery.
15843183|NCT04097782|Behavioral|Antenat education|Antenatal education group The primiparous pregnant women assigned to the intervention group participated in education classes in groups of 8-10 people. Pregnant women were given structured antenatal education twice a week for two weeks (240 minutes). The total education time was 16 hours. Each session comprised 150 minutes presentation of theoretical knowledge, 45 minutes warm-up and stretching exercises, and 45 minutes relaxation exercises.
15843184|NCT04097769|Drug|HX009|During study treatment, subjects will receive HX009 treatment via IV infusion once every 2 weeks at doses of 0.1, 0.3, 1, 2, 3, 5, and 7.5 mg/kg.
15843185|NCT04097756|Drug|LX-039 tablets|orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, or study termination
15843186|NCT04097743|Behavioral|Coping Statement|Daily practice of coping statement
15843187|NCT04097730|Drug|Moxifloxacin Ophthalmic|Topical moxifloxacin 0.5% is a fluoroquinolone antibiotic that is used to treat bacterial infections. This is standard therapy for bacterial keratitis. Immediately after CXL/sham CXL and repeat culture, all participants will receive topical moxifloxacin drops every 1 hour for 2 days, and then every 2 hours while awake until resolution of the epithelial defect.
15843188|NCT04097730|Drug|Difluprednate Ophthalmic|Difluprednate 0.05% is a corticosteroid used to reduce inflammation in the eye. Participants will receive one drop of 0.05% difluprednate four times daily beginning 24 hours after the initiation of antibiotics for 1 week, decreased by 1 drop weekly for a total of 4 weeks of steroid therapy.
15843189|NCT04097730|Drug|Riboflavin Ophthalmic|All participants will receive a 30 minute loading dose of topical 0.1% riboflavin and 20% dextran T500 drops every 2 minutes. For participants randomized to corneal cross-linking(CXL), this will be followed by exposure to UV-A light at a wavelength of 365 nm with an irradiance of 3 mW/cm2 for 30 minutes for a total dose of 5.4 J/cm2 (UV lamp: PESCHKE Meditrade GmbH, Hueneberg, Switzerland for India; Avedro KXL System, Waltham, MA, USA for USA). During irradiation patients will continue to receive topical riboflavin at 5-minute intervals. For those randomized to sham CXL, this experience is simulated however the light will be shined adjacent to the patient, careful to avoid exposure to the cornea.
15843190|NCT04097730|Other|Topical Placebo|Participants randomized to topical placebo will receive topical placebo on the same medication schedule as difluprednate: one drop of 0.05% difluprednate four times daily beginning 24 hours after the initiation of antibiotics for 1 week, decreased by 1 drop weekly for a total of 4 weeks of placebo therapy. Placebo will be the vehicle used in difluprednate.
15843191|NCT04097717|Behavioral|"My Decision tubal sterilization decision aid"|"The My Decision tubal sterilization decision aid is a web-based decision aid designed to help women make informed decisions about tubal sterilization."
15843192|NCT04097717|Other|Usual Care|Usual medical care will vary among participants.
15843193|NCT04097691|Drug|GLUCOSE 10%|subcutaneous glucose 0.5 ml per site around subcutaneous nerves
15843194|NCT04097678|Other|Retained Surgical Sponge|A surgical sponge will be intentionally placed in the surgical field prior to final imaging and then removed. Postoperatively, images will be assessed for the presence or absence of a retained surgical sponge.
15843195|NCT04097665|Device|indocyanine green angiography|All patients treated with expanded flaps will be assessed by surgeons, and the possible area of necrosis will be marked based on clinical experience. This area will be further divided into perfusion units (1*1 square centimeter for each), and the center of each perfusion unit will be marked. Then all patients will receive ICGA after the complete transfer of flap to the recipient site. For ICGA, a 2ml bolus of indocyanine green (2.5mg/ml) was injected through the patient's intravenous line. The detector/camera of the SPY imaging system should place over the flap at approximately 30cm for fluorescence image acquisition. The fluorescence value will be recorded afterwards.
15843196|NCT04097652|Biological|UMC119-06|Cohort 1: Low does of UMC119-06；Cohort 2: Medium does of UMC119- 06；Cohort 3: High does of UMC119-06
15843197|NCT04097626|Other|nutrition education|The experimental group will receive nutrition education once during the study. It will occur at the beginning of the second week. This will consist of a 30-minute interactive lecture and a 15-minute question-and-answer session. The information covered will be basic nutrition principles for good health and to support regular exercise.
15843198|NCT04097626|Other|no nutrition education|This group will not receive nutrition education.
15843199|NCT04097613|Drug|Povidone-Iodine|Povidone Iodine solution 5% (0.5% available iodine) by 3MTM has been specially formulated as a nasal antiseptic. They have shown topical application to be clinically safe, tolerable and to be rapidly bacteriocidal against aerobic gram positive and gram- negative bacteria including methicillin resistant Staphylococcus aureus, methicillin resistant Staphylococcus epidermidis, vancomycin resistant Enterococcus faecium and Enterococcus faecalis (VRE) and yeast (3M study 05-011100,05-011017, 05-011322).
15843200|NCT04097613|Drug|Budesonide|Budesonide is is provided in nebules (1mg/2cc). Patients will place two nebules of budesonide into the 250mls of saline.
15843201|NCT04097600|Drug|Oral semaglutide|Oral semaglutide current formulation and oral semaglutide new formulation, each in 3 different strengths, administered once daily during 6 treatment periods, each lasting 12 weeks
15843202|NCT04097587|Behavioral|experimental group|This program was carried out for 50 min/week over 8 weeks to empower parents with knowledge and self-efficacy about children's screen use, and motivate them to monitor and change their children's screen behaviors. Teaching strategies included lectures, group discussions, reflection, role playing, and peer sharing (Table 1). Topics included 1) parents' and children's screen use, 2) the relationship between network equipment and children's internet use, 3) the positive and negative effects of excessive screen use on children's physical and psychological development, 4) limiting screen use at mealtimes and bedtime, 5) strategies for screen-related devices, 6) alternative activities to screen use, such as board games and outdoor activities, 7) setting a target of appropriate screen times, and 8) encouraging the signing of a contract between parents and children to limit screen time. We also provided parents with a handbook of the course content.
15843203|NCT04097587|Other|control group|received standard school classes and usual activities offered at the kindergarten. Briefly, kindergarten activities included daily learning activities, outdoor activities, breakfast, lunch, snacks, and nap time.
15843204|NCT04097574|Drug|NPO-13: l-menthol|20 mL/site
15843205|NCT04097561|Biological|Belimubab|Belimumab 10 mg/kg once every 2 weeks for 3 doses, and then once every 4 weeks for 5 doses, delivered via 1-hour intravenous (IV) infusion.
15843206|NCT04097548|Behavioral|CenteringPregnancy|Pregnant women whose due dates are in the same month will receive ten 2-hour group prenatal care sessions according to the standard curriculum provided by the Centering Healthcare Institute.
15843207|NCT04097535|Other|PET/MRI|Imaging scan
15843208|NCT04097522|Other|Neurofeedback|During the neurofeedback intervention, participants will be shown visual representations of their own brain activity in real-time. Over a number of sessions participants will teach themselves to increase this brain activity, in order to increase their own pain resilience levels.
15843209|NCT04097509|Biological|AFG application on palatinal wound healing|9 ml venous blood collected from the patient was transferred to the tube without any anticoagulants. In the protocol, venous blood collected in the tube was centrifuged for 2 minutes at 2700 rpm (approximately 692 g) in a special centrifuge (Medifuge, Silfradent, Italy) to obtain two layers: the lower layer of red blood cells and the upper layer of AFG. The AFG at the top of the tube was collected by means of an injector and transferred to the metal godet. It was held for 15-20 minutes for polymerization. After polymerization occurred, the polymerized AFG in the metal gum was applied to the wound surface in the donor site . No suture or tissue glue was used. Adhesive properties of AFG were utilized.
15843210|NCT04097509|Biological|i-PRF application on palatinal wound healing|10 ml venous blood collected from the patient was transferred to the tube without any anticoagulants. Based on G force, collected venous blood were centrifuged at 2300 rpm (about 241 g) in a centrifuge (PC-O2, Process for PRF, Nice, France) for 3 minutes to obtain two layers: The two layers are the lower layer of red blood cells and the upper layer of i-PRF. The i-PRF at the top of the tube was collected with a syringe and transferred to the metal godet. It was held for 20-25 minutes for polymerization. After the polymerization, the polymerized i-PRF was applied to the wound surface in the donor site. No suture or tissue glue was used. Adhesive properties of AFG were utilized.
15843211|NCT04097509|Other|control|no application
15843212|NCT04097496|Behavioral|Act Out! Intervention|Data included in the description of the intervention arm.
15843213|NCT04097483|Behavioral|Telephone Intervention Group|Nurse-led, telephone-based, and psychoeducational intervention centered on motivational interviewing and cognitive behavioral therapy for adherence and depression.
15843214|NCT04097470|Drug|Decitabine|Decitabine dosage 20mg/m2 i.v.
15843215|NCT04097470|Drug|Midostaurin|Midostaurin 50 mg b.i.d.
15843216|NCT04097457|Behavioral|"Parent training for disruptive behaviors manual (Bearss, Johnson, Handen, Butter, Lecavalier, Smith & Scahill, 2018)"|"The intervention is a short term parent training program based on behavioral principles, which can be delivered by trained therapist. The manual includes eleven core sessions, home visit session, follow-up telephone booster sessions and seven supplemental sessions, designed to be delivered individually to parents in an outpatient setting.
~The protocol will be administered to groups of 3-4 parents, with a quantitative pretest-post test design evaluated at five time points, including a follow up at one month post intervention. The protocol will be administered in various community and educational locations, such as schools and community centers"
15843217|NCT04097444|Biological|Bevacizumab|Given IV
15843218|NCT04097444|Drug|5-fluorouracil|Given IV
15843219|NCT04097444|Drug|Leucovorin calcium|Given IV
15843220|NCT04097444|Drug|Irinotecan hydrochloride|Given IV
15843221|NCT04097444|Drug|Oxaliplatin|Given IV
15843222|NCT04097444|Drug|Capecitabine|Given PO
15843223|NCT04097431|Behavioral|Response Blocking|Physically preventing the response (i.e., precursor) from occurring.
15843224|NCT04097418|Behavioral|Aerobic training compared to conventional motor training|"Aerobic training: aerobic training by treadmill at moderate intensity. Each treatment will consists of 35 minutes of training, administered 3 times per week, for 8 weeks.
~Conventional motor training: 15 minutes of passive mobilization of upper and lower limbs and spine, 5 minutes of stretching of the upper and the lower limbs and 10 minutes of balance training, administered 3 times per week, for 8 weeks."
15843225|NCT04097405|Drug|D-0120|Randomized, Double-Blind, Placebo-Controlled, Multiple Dose and Dose Escalation of D-0120 or Placebo
15843226|NCT04097405|Drug|Placebo oral tablet|Randomized, Double-Blind, Placebo-Controlled, Multiple Dose and Dose Escalation of D-0120 or Placebo
15843227|NCT04097392|Other|Experimental|Diaphragm biofeedback reeducation plus inspiratory training during 6 weeks
15843228|NCT04097392|Other|Active comparator|Isolated high-intensity inspiratory muscle training during 8 weeks
15843229|NCT04097379|Drug|LRX712|LRX712 intra-articular injections
15843230|NCT04097379|Drug|Placebo|Placebo intra-articular injections
15843231|NCT04097366|Diagnostic Test|ABUS|Automated whole breast ultrasound (ABUS) is undertaken with a large transducer panel placed on the breast in three positions. Resultant images are combined to make a 3D image of the breast.
15843232|NCT04097366|Diagnostic Test|CESM|A high kV and a low kV image is taken in two standard views of each breast following the intravenous injection of an iodinated contrast agent.
15843233|NCT04097366|Diagnostic Test|ABB-MRI|ABB-MRI is a shorter version of breast MRI. Standard T1W pre and post contrast images are acquired. A MIP and post-contrast T1 weighted image are read.
15843234|NCT04097353|Behavioral|Harvesting Hope for Kids (HH4K)|Weekly meetings at university-based farm
15843235|NCT04097353|Behavioral|Surviving Strong for Kids (SS4K)|Enhanced usual care
15843238|NCT04097327|Other|Ectoin Dermatitis Cream 7% (EHK02)|Application of Ectoin Dermatitis Cream in accordance with the instructions for use
15843239|NCT04097314|Drug|Zibotentan|10mg OD Zibotentan
15843240|NCT04097314|Drug|Placebo oral tablet|Placebo
15843241|NCT04097301|Drug|MLM-CAR44.1 T-cells, cyclophosphamide and fludarabine from -5 to -3|Single intravenous infusion
15843242|NCT04097288|Drug|Citalopram 40mg|Single dose
15843243|NCT04097288|Drug|Reboxetine 8 mg|Single dose
15843244|NCT04097288|Drug|Placebo oral tablet|Single dose
15843245|NCT04097288|Drug|Placebo oral tablet|Single dose
15843246|NCT04097275|Other|Skin biopsy|The biopsy will be performed by means of punch biopsy (diameter 2.5 mm) under local anesthesia on a forearm. The skin biopsy will be transferred to sterile cell culture Dulbecco's Modified Eagle Medium (DMEM) 1% Penicillin 1% Streptomycin 1% Gentamycin medium 10% FBS.
15843247|NCT04097275|Other|Withdraw of blood|"Blood will be collected in:
~1 x Ethylene Diamine Tetraacetic Acid (EDTA) tube (7.5 ml) - for further leucocytes extraction that are a potential backup for new iPS cell lines generation
~1 x Citrate Phosphate Dextrose Adenine (CPDA) tube (8.5 ml) - for EBV-transformed lymphoblastoid cell lines generation
~1 x Dried Blood Spot DBS-filtercard, called CentoCard® - for quality control confirmatory genetic testing"
15843248|NCT04097262|Other|Own-Price Elasticity|The price of fruit will be 75%, 100%, or 125% of the reference price, but the price of other foods will remain the same.
15843249|NCT04097262|Other|Cross-Price Elasticity|The price of fruit will remain the same, but the price of other foods will be 75%, 100%, or 125% of the reference price.
15843252|NCT04097210|Diagnostic Test|POC|
15843253|NCT04097197|Behavioral|Brief educational intervention|same as before
15843254|NCT04097184|Device|Neurostimulation with non-implanted electrodes|Neurostimulation with non-implanted electrodes
15843255|NCT04097171|Other|Diet|Participants will consume each diet for 14 days in a crossover design.
15843256|NCT04097158|Other|Sample Collection|The investigators will be collecting blood, urine, and spinal fluid samples.
15843257|NCT04097145|Device|Edwards PASCAL System|Transcatheter tricuspid valve repair with the Edwards PASCAL System in patients on optimal medical therapy
15843258|NCT04097145|Drug|Optimal Medical Therapy|Optimal Medical Therapy alone in patients with tricuspid regurgitation
15843259|NCT04097132|Device|echocardiography|echocardiography for left atrial diameter, size ,Ejection Fraction Holter for detection of paroxusmal AF
15843260|NCT04097119|Dietary Supplement|Dietary supplementation|Subjects receive a specific dietary supplementation designed to support HDL function daily for 12 weeks
15843261|NCT04097106|Dietary Supplement|Synbiotic|Synbiotic dietary supplement in capsule form
15843262|NCT04097093|Other|No intervention|No intervention
15843263|NCT04097080|Drug|NBTX-001|Active drug group will receive 6 doses of NBTX-001 given three times a week.
15843264|NCT04097080|Drug|Standard of Care|Placebo group will receive reconstituted air given three times a week.
15843265|NCT04097067|Radiation|Radiation Therapy|Low dose radiotherapy with 20 Gy (10x2Gy)
15843266|NCT04097054|Procedure|Augmented preoperative planning|The study investigates the impact of augmented preoperative planning on OR time variance in complex and rare visceral surgical procedures.
15843267|NCT04097041|Procedure|Tympanomastoidectomy|Patient undergoes tympanomastoidectomy (approx 2 hour operation on ear and mastoid) where a local soft tissue flap is transferred to cover the sigmoid sinus, a cartilage and perichondrial graft is taken from the tragus to cover the jugular bulb).
15843306|NCT04096638|Drug|SB 11285|SB 11285 2mg lyophilized powder for IV infusion
15843307|NCT04096638|Drug|Atezolizumab|1680 mg every 4 weeks
15843308|NCT04096625|Device|Active tDCS|Active tDCS will be delivered at 2mA for 20 minutes.
15843309|NCT04096625|Behavioral|Assertiveness Training Program (ATP)|The Assertiveness Training Program (ATP) is a cognitive-behavioural therapy delivered in group sessions.
15843268|NCT04097041|Procedure|Non-Surgery|"Screening performed at outpatient clinic after consultation for management of venous pulsatile tinnitus. Consent and formal recruitment into study performed at preoperative visit or at audiological visit.
~The masking device is a hearing aid that provides sound that is aimed to negate the internal sound from the pulsatile tinnitus. Almost all hearing aid can be converted to a masking device for tinnitus. It is externally worn on the ear and provides sound at a desired volume. The benefits of wearing the masking device are that it may reduce the volume of the pulsatile tinnitus. As it is worn on the external ear and is not invasive there are minimal risks but potential risks could include irritation of the external ear and discomfort from wearing."
15843269|NCT04097028|Drug|Trifluridine and Tipiracil Hydrochloride|Given PO
15843270|NCT04097028|Drug|Oxaliplatin|Given IV
15843271|NCT04097015|Device|Alpha-Stim M|Alpha-Stim M with and Ocular Interface and a Spinal Interface
15843272|NCT04097002|Biological|ORCA-010|The investigational new drug ORCA-010 is a novel and improved oncolytic adenovirus based on the adenovirus serotype 5 (Ad5) genome. ORCA-010 replicates specifically in cancer cells and not in normal tissue cells. Its replication has been shown in a wide variety of cancer cell types, and it is not limited to prostate cancer.
15843273|NCT04096989|Other|Traditional Chinese medicine regimen-based lifestyle mobile health APP|The Experimental group receives TCM regimen-based lifestyle mobile health application intervention.
15843274|NCT04096989|Other|Lifestyle mobile health APP|Sham comparator group receives mobile health application, but there is no traditional Chinese medicine information.
15843275|NCT04096976|Other|logistic regression|To identify associations between factors listed in Table 1 and hospital survival, we used logistic regression
15843276|NCT04096963|Device|The WATCHMAN FLX Delivery System|WATCHMAN FLX Delivery System permit device placement in the LAA via femoral venous access and crossing the inter-atrial septum into the left atrium
15843277|NCT04096950|Biological|MT-3921 Low dose|MT-3921 Low dose, intravenous, single dosing
15843278|NCT04096937|Other|Focus groups|Focus groups will be conducted with adult stakeholders and with youth in Appalachia. Feedback from the focus groups will guide cultural tailoring of the Journey of Hope in Appalachia intervention for use in a later phase.
15843279|NCT04096924|Device|Guidewire for echo-guided interventions|Under echocardiography guided treatment of ASD with a novel interventional guidewire
15843280|NCT04096924|Device|Cook lunderquist guidewire|Subjects with ASD treated with amplatzer using the Cook lunderquist guidewire.
15843281|NCT04096911|Drug|Sintilimab|Sintilimab 200 mg intravenously every 3 weeks
15843282|NCT04096911|Drug|quadrivalent HPV vaccine|The first dose of quadrivalent HPV vaccine intramuscularly at the day before the first dose of Sintilimab ，the second and third doses of quadrivalent HPV vaccine intramuscularly at the 60th and 180th days respectively
15843283|NCT04096898|Device|Senofilcon A contact lens|Senofilcon lenses will be tested in moderate to severe dry eye patients to determine their efficacy in reducing discomfort associated with dry eye.
15843284|NCT04096885|Diagnostic Test|Blood and urine samples, skin and stool swabs|Blood samples will be collected before surgery, on the first postoperative day and after 3-8 weeks. Urine samples will be collected after surgery and after 3-8 weeks. Stool and skin swabs will be collected before surgery.
15843285|NCT04096846|Diagnostic Test|laboratory investigation|detection of serum level of methotrexate and serum level of vitamin D
15843286|NCT04096833|Other|Virtual Reality Group|Participants are from 3 to 14 years old who attend a pediatric primarey health care of the Fuensanta Health Center (Valencia) for immunization by vaccine.
15843289|NCT04096781|Behavioral|SDMT|The intervention involves a clear pathway centered on the use of a web-based decision tool. This tool aims to support the shared decision-making process for anticoagulation for stroke prevention in atrial fibrillation. This web-based tool will be used both by the participants as well the physician responsible for atrial fibrillation decision making.
15843290|NCT04096781|Behavioral|Usual Care|The participants will receive usual care.
15843291|NCT04096768|Drug|Dexmedetomidine|Comparing Dexmedetomidine + Ketamine versus Dexmedetomidine + Placebo for sedation in ICU patients
15843292|NCT04096768|Drug|Ketamine|Comparing Dexmedetomidine + Ketamine versus Dexmedetomidine + Placebo for sedation in ICU patients
15843293|NCT04096755|Diagnostic Test|Procedure|serum and urine samples will be taken for analysis
15843294|NCT04096742|Drug|tretinoin 0.05% lotion (Altreno)|Altreno topical lotion
15843295|NCT04096742|Other|Vehicle|Lotion not containing active ingredient (tretinoin)
15843296|NCT04096729|Other|compression stockings|patients will be prescribed compression therapy for varicose veins of the legs using compression stockings
15843298|NCT04096703|Procedure|Pneumatic dilation|The patients randomized to the pneumatic dilation cohort will undergo an initial pneumatic dilation with a 30mm Rigiflex (Boston Scientific). If the Eckardt score four weeks after initial dilation is > 4, then the patient will be scheduled for a second dilation with a 35mm Rigiflex balloon (Boston Scientific).
15843299|NCT04096690|Drug|Pegaspargase|Pegaspargase 3750IU administered by intramuscular injection on Day 1 of each 21-day cycle for 6 cycles in induction treatment
15843300|NCT04096690|Drug|Anti-PD-1 monoclonal antibody|Anti-PD-1 antibody 200mg administered intravenously (IV) on Day 2 of each 21-day cycle for 6 cycles in induction treatment Anti-PD-1 antibody 200mg administered intravenously (IV) on Day 1 of each 21-day cycle for up to 28 cycles in maintenance treatment
15843301|NCT04096677|Procedure|hysteroscpy|
15843302|NCT04096664|Device|SIMEOX|Use without obligation, in autonomous and at home of the bronchial clearance device: SIMEOX
15843303|NCT04096651|Other|gait recordings|gait recordings
15843304|NCT04096651|Other|brain magnetic resonance imaging|brain magnetic resonance imaging
15843305|NCT04096651|Other|oculomotor movement recordings|oculomotor movement recordings
15843310|NCT04096625|Device|Sham tDCS|Sham tDCS, after 40 seconds of stimulation (2mA), a small current pulse was delivered every 550 msec (110 muA over 15 msec).
15843311|NCT04096612|Procedure|Orbital decompression combined with MPT|Orbital decompression combined with MPT
15843312|NCT04096599|Other|Xylitol toothpaste|At-home preventive measures + xylitol-containing (25%) toothpaste
15843313|NCT04096599|Other|Fluoride toothpaste|At-home preventive measures + fluoride (1000 ppm F) toothpaste
15843314|NCT04096586|Other|Red juice|To determine the effects of red juice on satiety and gut health
15843315|NCT04096586|Other|Watermelon juice|To determine the effects of watermelon juice on satiety and gut health
15843316|NCT04096573|Drug|LC51-0255|LC51-0255
15843317|NCT04096573|Drug|Placebo|Placebo
15843318|NCT04096560|Drug|TAK-994|TAK-994 tablets.
15843319|NCT04096560|Drug|Placebo|TAK-994 placebo-matching tablets.
15843320|NCT04096547|Drug|Rivaroxaban|rivaroxaban for stroke prevention of atrial fibrillation
15843321|NCT04096534|Procedure|Normotonic partial nephrectomy|partial nephrectomy performing with avoidance of hypotension: mean blood pressure more or equal 65 mm Hg
15843322|NCT04096534|Procedure|Hypotonic partial nephrectomy|partial nephrectomy performing with using of medical hypotension; avoidance of hypertension: mean blood pressure less than 65 mmHg
15843323|NCT04096508|Behavioral|Music listening|Patients sit comfortably in a chair for 20 min listening music before the procedure.
15843324|NCT04096482|Device|Peregrine Drivable ENT Scope|Peregrine, developed by 3NT Medical, is a single-use disposable handheld endoscope, which is thinner and more flexible than other endoscopes. The endoscope includes a camera at its end and a working channel. The thin endoscope provides a means to visualize the nasal cavity and paranasal sinus space and to deliver irrigation to treat the sinus ostia (drainage openings) and spaces within the paranasal sinus cavities
15843325|NCT04096482|Device|Standard 30° 4mm Endoscope|The Standard 30° 4mm endoscopic sinus evaluation is the standard procedure that would normally be used to evaluate the condition of each participant.
15843326|NCT04096469|Behavioral|Motivational Interviewing|The motivational interviewing strengthens the motivation and commitment to achieve a specific change through the induction and exploration of the reasons for modifying behavior. All this within an atmosphere of acceptance and compassion. It is about extracting the possible solutions to the change that is faced from the individual and his environment and not from the professional. This strategy is achieved by looking for the patient to feel motivated, and to express their problem and thus create discrepancy so that they evaluate their actions and reflect on the changes they should make.
15843327|NCT04096469|Behavioral|Traditional Education|Traditional education refers to the normal care given to breast cancer survivors. That is, they receive recommendations about their physical activity and diet but without any motivational approach.
15843328|NCT04096443|Biological|Fecal microbial transplant (FMT)|Oral fecal microbial transplant capsules
15843329|NCT04096430|Behavioral|ENGAGE approach (child-oriented goal-setting)|See description of experimental arm.
15843330|NCT04096417|Drug|Pemigatinib|Given PO
15843331|NCT04096417|Other|Quality-of-Life Assessment|Ancillary studies
15843332|NCT04096404|Genetic|Genotype- based personalised advice|Following allocation to groups participants will receive appropriate dietary and physical activity advice based on their genotype via email
15843333|NCT04096404|Behavioral|Non genetic personalised advice|Following allocation to groups participants will receive appropriate dietary and physical activity advice based on their reported intake, BMI and activity via email
15843334|NCT04096391|Device|Flowonix Prometra® II Programmable Infusion System|The Flowonix Prometra® II Programmable Infusion System consists of an implanted infusion pump and catheter, and external components including a clinician programmer, refill and catheter access port kits, the PTC™(a subject operated controller).
15843335|NCT04096391|Drug|Pain Medicine|Injections, spinal cord stimulation, peripheral nerve stimulation, pain medication, etc.
15843336|NCT04096378|Behavioral|EMBRace Intervention Group|The EMBRace intervention will consist of five weekly sessions (weeks 2 - 6) that will be facilitated by EMBRace-trained therapists. Throughout the 8-week intervention, families will be scheduled for 2-hour blocks with sessions being administered to each parent and adolescent for 90 minutes (individually for 30 minutes, 15-minute break, and 45-minutes session with parent and adolescent together). The sessions will cover research-based types of Racial Socialization, including cultural pride, preparation for bias, and attentiveness and balance towards societal racism. Parents and youth will also learn and practice five literacy skills to process and manage the stress of racial encounters including the ability to recognize racial discrimination, accurately appraise the stress of self and others, reduce one's stress, engage instead of avoid, and finally resolve toward healthy outcomes.
15843337|NCT04096378|Behavioral|EMBRace Waitlist Group|The waitlist group will be asked to complete a pretest and posttest while the treatment group goes through the EMBRace intervention. During this time, the waitlist group will not have any additional requirements and will not be given any form of comparative treatments. Upon the completion of the treatment from the intervention group, the waitlist group will be consented for entry into the intervention arm of the study and will follow the procedures for the intervention group above.
15843338|NCT04096365|Device|Subcostal Temporary Extracardiac Pacing Lead|The StealthTrac Lead is designed to facilitate extracardiac temporary ventricular pacing and sensing. The distal end of the StealthTrac Lead is designed to reside within the connective tissue of the anterior mediastinum outside the pericardium. The StealthTrac Lead is delivered using the MACH I Delivery Tool, which is designed to facilitate insertion of the StealthTrac Lead through a small skin incision parallel to the sternum, without the need for fluoroscopic guidance.
15843339|NCT04096352|Behavioral|Direct Method|Learning effective vocal skills using speech therapy exercises and virtual reality simulations.
15843340|NCT04096352|Behavioral|Indirect Method|Information on voice function and voice hygiene.
15843341|NCT04096339|Other|Colonoscopy followed by EGD|Colonoscopy is done first followed by EGD
15843342|NCT04096339|Other|EGD followed by Colonoscopy|Esophagoduodenoscopy (EGD) is done first followed by Colonoscopy
15843343|NCT04096326|Drug|AGN-151586|Participants will receive 5 injections (1 in the procerus, 2 in each of the bilateral corrugators). Up to 5 cohorts will be enrolled in this study.
15843344|NCT04096326|Drug|Placebo|Participants will receive 5 injections (1 in the procerus, 2 in each of the bilateral corrugators) of placebo matched AGN-151586
15843348|NCT04096274|Behavioral|Leadership for Organization Change and Implementation (LOCI)|LOCI is a leadership training and coaching program designed to support leaders and foster a climate that implements and sustains use of evidence based practices.
15843349|NCT04096274|Behavioral|Leadership web-based seminars|A set of 4 leadership training web-based seminars will be provided that cover topics ranging from effective leadership, to giving effective feedback.
15843350|NCT04096261|Diagnostic Test|Diagnostic Test|Diagnostic Test: Contrast agentenhanced MRI using Gadovist by using the contrast agent Gadovist we aim to visualize the blood-brain barrier. Furthermore, we aim to measure a newly developed biomarker of the blood-brain barrier in the cerebro-spinal fluid. And sleep quality measurement with a polysomnography.
15843351|NCT04096235|Other|RAM Nasal Cannula|The RAM Nasal Cannula is a means of providing CPAP and Bi-PAP to infants 28-42 weeks gestation to prevent nasal septal erosion.
15843352|NCT04096209|Device|autograft mixed with xenograft bone|"Eligible patients will be randomized in equal proportions between control group (immediate implant placement without bone grafts in the jumping gap) and study group (immediate implant placement with a mixture of Xenograft and autogenous bone placed in the jumping gap).
~All patients will be evaluated by proper history taking and thorough clinical and radio graphical examination and assessed according to the inclusion and exclusion criteria.
~Patients of both groups will be subjected to Cone beam Computed tomography (CBCT).
~Primary impression will be taken, a study model will then be poured and then waxing up will be performed.
~Patients will be instructed to rinse with chlorhexidine 0.1% mouthwash. Articaine 4% (1:100,000) local anesthesia will be given to the patient. Atraumatic extraction of the tooth or remaining root using No. 15c lancet and periotome"
15843353|NCT04096196|Behavioral|Safe City game|The game intervention uses a game-based learning approach to teach players how to recognize and remove injury hazards from different homes and sports areas. It also highlights the need to pay attention to traffic and safety facilities to prevent injuries in a real-world environment. Players will create their own avatar to assume the duties of safety inspectors in the game. Point, level and reward systems will be included to increase player motivation to engage in the game.
15843354|NCT04096196|Other|Health education|All students in the health education group will receive a comprehensive package on safety information. The information package includes both printed and electronic promotional materials regarding safety and a comprehensive list of relevant website and information sources. The information from these relevant websites and information sources are similar to those used in setting the safety case scenarios for the Safe City game. As a result, both intervention arms will have comparable accessibility to safety-related information and the major contrast between the two groups will be the method of presentation (game-based learning vs traditional health promotion approach, i.e. unidirectional information package).
15843355|NCT04096183|Other|Ventilation of healthy volunteers|Ventilation of healthy volunteers in different clinical situations
15843356|NCT04096170|Drug|IV lidocaine|Patients randomized to the IV lidocaine group will receive a 100 mg lidocaine bolus on induction then an infusion of 1.5 mg/kg/hr prior to incision. This infusion will continue throughout operation and into the PACU for 1 hour OR until the 2gm/250 mL D5W bag has been infused, whichever occurs first.
15843357|NCT04096170|Drug|Placebo|o Patients randomized to the placebo group will receive D5W solution (as this is the carrier for lidocaine) at the same volume and rate as the IV lidocaine.
15843358|NCT04096157|Drug|Isavuconazonium sulfate IV|Intravenous (IV) via nasogastric (NG) tube
15843359|NCT04096157|Drug|Isavuconazonium sulfate capsules|Oral
15843360|NCT04096144|Drug|Neuromuscular Blocking Agents|Neuromuscular agents will be used to block muscle function for the safety and efficiency of the procedure. At the procedure's conclusion, neuromusclar agents such as Neostigmine or Sugammadex will be used to reverse the neuromuscular reversal.
15843361|NCT04096131|Procedure|cataract surgery|phacoemulsification
15843362|NCT04096105|Drug|CC-93538|a single dose CC-93538 SC
15843363|NCT04096092|Other|No intervention|No intervention
15843364|NCT04096066|Drug|Carfilzomib|"20 mg/m2 IV on day 1 of cycle 1 enhanced to 56 mg/m2 on days 8, and 15 of cycle 1;
~56 mg/m2 IV on days 1, 8 and 15 in cycles 2-12;
~56 mg/m2 IV on days 1 and 15 from cycle 13 and onwards."
15843365|NCT04096066|Drug|Lenalidomide|- 25 mg orally on days 1-21 of each cycle.
15843366|NCT04096066|Drug|Dexamethasone|"- 40 mg orally on days 1, 8, 15 and 22 of each cycle. Each cycle is to be repeated every 28 days. Patients that achieve at least a VGPR within the first year of study treatment and in sustained MRD negativity (MRD negative at least at 10-5 after 1 and 2 years of therapy) will stop carfilzomib administration after 2 years and will continue with lenalidomide and dexamethasone treatment until disease progression or intolerance to the therapy. Other patients will continue carfilzomib administration until disease progression or intolerance.
~For patients >75 years of age, the dose of dexamethasone is 20 mg/day on Days 1, 8, 15 and 22 of each treatment cycle."
15843367|NCT04096053|Other|TEACHH|See arm/group description.
15843368|NCT04096040|Device|μCor|μCor consists of the following components: A) Patch B) Sensor C) Charger D) Data transmission device (Gateway) E) Server Once activated, the wearable Sensor automatically acquires ECG, RF readings, heart rate, respiration rate, activity, and posture measurements.
15843369|NCT04096027|Drug|Cabergoline Pill|0.5 mg cabergoline pill taken orally
15843370|NCT04096014|Dietary Supplement|Ensure Enlive|The subjects in the intervention group will receive two Ensure Enlive supplements per day for 180 days.
15843371|NCT04096014|Other|Standard Of Care|The subjects in the Standard of care group will continue to receive the standard clinical therapy.
15843372|NCT04096001|Device|Woebot-SUDs (W-SUDs)|Woebot-SUDs (W-SUDS), an artificially intelligence-powered conversational agent on a smartphone app, eliminates most current SUDs treatment barriers while simultaneously leveraging technology to enhance user experience and engagement. W-SUDs expands and refines existing SUDs treatments by adapting skills from cognitive behavioral therapy, motivational interviewing, and dialectical behavior therapy.
15843373|NCT04095988|Procedure|Allogeneic microbiota reconstitution|gastroscopic microbiota Infusion (Verum)
15843374|NCT04095988|Procedure|Placebo-Allogeneic microbiota reconstitution|gastroscopic saline Infusion (placebo)
15843375|NCT04095975|Dietary Supplement|Baking Soda|Standard baking soda that can be bought from stores.
15843376|NCT04095975|Dietary Supplement|LithoLyte|LithoLyte is considered a medical food and consists of: potassium citrate, magnesium citrate, sodium bicarbonate, and erythritol.
15843377|NCT04095962|Other|Exercise|The MT program will be conducted for 6 months, twice a week in 60 minutes sessions. Sessions will be divided in warm-up (10 minutes, including slow walk, postural and mobility exercises for general activation, and stretching exercises), specific training (35-45 minutes, including balance/coordination training, strength and aerobic exercises) and cool down (5 minutes with breathing and stretching exercises for the main worked joints and muscles) following the main guidelines recommended by the American College of Sports Medicine [18] and the WHO [19].
15843378|NCT04095949|Dietary Supplement|Artichokes|Approximately 200 g of cooked artichokes
15843379|NCT04095936|Drug|Romiplostim|Subcutaneous administration of 0 to 20ug/kg for 6 months
15843380|NCT04095923|Behavioral|Social media game|Participants will engage in weekly challenges that require them to take photographs of interesting things they discover during their walks. They will post and discuss these photographs with other participants on a private social media page. They will track their steps using a wearable activity monitor and receive brief standard self-regulatory counseling.
15843381|NCT04095923|Behavioral|Standard self-regulation|Participants will track their steps using a wearable activity monitor and receive brief standard self-regulatory counseling.
15843382|NCT04095910|Behavioral|Planet Nutrition program|"- Nutritional education sessions: The study team previously worked on the development of a handbook called Planet Nutrition which contains around 26 topics of nutrition and health. Interns from the Nutritional Sciences Degree of the University of Sonora implemented the sessions. 2 classes of 1 hour were given weekly, adding 18 sessions in total, during regular school hours. The program contemplates the establishment of different objectives.
~- Physical activity: The classes were designed and implemented by interns from the Bachelor of Physical Culture and Sport from the University of Sonora along with a teacher from the study team. 3 weekly sessions of 1 hour were provided. The activities were held on the schoolyard court during normal school hours, independent of the physical activity classes of the school.
~- Indirect family participation: Six information brochures with different nutrition and health topics were sent to parents."
15843383|NCT04095897|Procedure|Pecs II Block|Peripheral nerve block - Regional anesthesia : Pectoral Nerve block type 2
15843384|NCT04095884|Procedure|blood sampling|observational study and no intervention will be given. only blood samples collected and treated with iron supplements
15843385|NCT04095871|Other|Observational study|No intervention, patients record the time of CISC
15843386|NCT04095858|Drug|CD24Fc|IV infusion: 480 mg at Day -1, 240 mg at Day 14, 240 mg at Day 28.
15843387|NCT04095858|Drug|Placebo|IV infusion, 100 ml at Day -1, Day 14, and Day 28.
15843388|NCT04095858|Drug|Methotrexate|IV, 15 mg/m^2/dose at Day 1, then 10 mg/m2/dose at Day 3, 6, 11.
15843389|NCT04095858|Drug|Tacrolimus|Begin on day -3. IV [0.03 mg/kg/day] or PO [0.045 mg/kg/dose] dosing is permitted
15843390|NCT04095845|Device|CO THA|Replacement of arthritic hip with artificial implant using CT-based navigation and conventional technique
15843391|NCT04095845|Device|Mako THA|Replacement of arthritic hip with artificial implant using mako robotic-arm assist
15843392|NCT04095832|Procedure|Epidural anesthesia|Epidural anesthesia using standardized technique
15843393|NCT04095819|Procedure|Middle Meningeal Artery procedure|Seal off the blood supply to the middle meningeal artery to prevent growth of the Subdural Hematoma
15843394|NCT04095819|Procedure|Traditional Surgery|Drainage of Subdural Hematoma using Craniotomy or Burr Hole
15843395|NCT04095806|Other|Stroke (exposure)|stroke case definition (exposure) listed in inclusion/exclusion criteria section
15843397|NCT04095780|Other|Advanced oral hygiene care programme|"Brush teeth with standardized power tooth brush twice a day.
~Rinse mouth with chlorhexidine twice a day.
~Oral hygiene education"
15843398|NCT04095780|Other|Oral hygiene instruction|Oral hygiene education
15843399|NCT04095767|Device|Neurothrombectomy|Intra-arterial recanalization therapy or mechanical thrombectomy (MT) is a therapeutic option for patients who are not candidates for t-PA or in whom t-PA has failed. MT is performed by means of various devices (Merci Revive, Penumbra, etc.). There are currently two major approaches to MT: the so-called stent retrievers (used with or without a balloon catheter), and catheters used for direct aspiration (manual with syringe or by aspiration pump via distal access catheters [DACs]). Moreover, both techniques can be combined. MT may be performed following IV t-PA, as a stand alone therapy, or in conjunction with IA thrombolysis.
15843400|NCT04095754|Procedure|Head-Up Position|Anti-Trendelenburg Position
15843401|NCT04095754|Drug|Dexmedetomidine|Controlled hypotension: All patients will receive dexmedetomidine 1mcg. Kg-1 loading dose over 10 min just before induction, followed by continuous infusion of 0.4 mcg.kg-1hr-1
15843402|NCT04095754|Drug|Induction and maintenance of anaesthesia|"Induction of anaesthesia: fentanyl 1 μg.Kg-1, propofol 1.5-2 mg.kg -1 titrated to loss of verbal response, atracurium 0.5 mg. Kg-1 to facilitate endotracheal intubation.
~Maintenance:Anaesthesia will be maintained using isoflurane 1 % in oxygen and air mixture 1:1 and atracurium 0.1 mg. Kg-1 every 20 mim."
15843403|NCT04095741|Diagnostic Test|Questionnaires|Filling in questionnaires of general functioning and symptomes of anorexia nervosa and autism spectrum disorders will demanded to children and their parents. The children all have a history of anorexia nervosa.
15843404|NCT04095728|Dietary Supplement|Brain Octane Oil|Participants will complete a 7-day dose escalation period, and then consume 2 servings of the study product (1 serving = 1 tablespoon) for 21 days.
15843405|NCT04095728|Other|Placebo|Participants will complete a 7-day dose escalation period, and then consume 2 servings of the study product (1 serving = 1 tablespoon) for 21 days.
15843406|NCT04095715|Other|Haemostasis consultation|Haemostasis consultation
15843407|NCT04095715|Biological|Standard management of patients suspected of thrombopathy|Standard management of patients suspected of thrombopathy
15843408|NCT04095702|Other|Weighted Pacifier|The weighted pacifier is a standard of care pacifier with a weighted, breathable star attachment to help keep the pacifier from popping out of the neonates mouth during non-nutritive suck.
15843409|NCT04095702|Other|Non-Weighted Pacifier|The non-weighted pacifier is a standard of care pacifier that a neonate would receive if they were not part of this study.
15843410|NCT04095689|Drug|Docetaxel|Microtubule-targeting drug (inhibits microtubule depolymerization)
15843411|NCT04095689|Drug|Pembrolizumab|Programmed cell death-1 (PD-1) inhibitor
15843412|NCT04095689|Drug|IL-12 gene therapy|Adenoviral-mediated IL-12
15843414|NCT04095676|Procedure|VATS group|VATS procedure with drainage, including rinse with NaCl
15843415|NCT04095676|Procedure|Drain and intrapleural therapy group|Drainage with pigtail and Intrapleural therapy
15843416|NCT04095663|Procedure|Partial Colectomy|Most partial colectomies are performed using a laparoscopic approach, when possible, and surgeons sometimes use a temporary, protective stoma if the re-connection is considered high risk.
15843417|NCT04095663|Other|Medical Management|"Patients will be offered a varying combination of tools from the best medical management toolbox (diet and exercise, fiber supplementation/probiotics, and rifamycin/mesalazine) depending on what they have already tried. Based on the evidence-based best medical toolbox clinicians will be asked to consider rifamycin (dose/frequency) for those with AUD who are not responding to diet and exercise and mesalazine (dose/frequency) for those with lingering symptoms who are not responding to diet and exercise."
15843418|NCT04095650|Behavioral|STEPS (Seniors using Technology to Engage in Pain Self-management)|Participants will meet with a community health worker (CHW) at a one-hour in-person study orientation session. At this session, they will be introduced to the program, learn how to use the online modules and associated materials, and schedule six weekly telephone sessions with the CHW. Participants will be given a wearable physical activity tracker to use throughout the course of the program. They can choose to report daily step counts by automatically syncing to an app or via text message. Each week during the study period, participants will engage with content on the website, have a session with the community health worker, track their daily steps, and set and work toward pain-management goals.
15843419|NCT04095637|Device|Medial knee arthroplasty|Surgical intervention where the medial portion of the knee is replaced by an artificial metal and polyethylene implant
15843420|NCT04095624|Behavioral|Spinal Fusion Preoperative Opioid Taper|Guided weekly opioid pain medication reduction via telephone calls prior to elective spinal fusion surgery.
15843421|NCT04095624|Other|Non-taper Control|Weekly phone calls prior to elective spinal fusion surgery, without opioid pain medication reduction recommendation or guidance.
15843422|NCT04095611|Procedure|SPAIRE|To perform the hip surgery called hemiarthroplasty surgeons need to cut through some muscles to expose the hip joint and perform the partial replacement. Currently this often performed using a technique which involves cutting muscles and tendons from the side of the hip and this is called the lateral approach. SPAIRE is a modified technique that accesses the surgical area through a different route.
15843423|NCT04095611|Procedure|LATERAL|surgery in adults with a displaced intracapsular hip fracture requiring hemiarthroplasty, the standard lateral approach.
15843424|NCT04095598|Diagnostic Test|Comparative Ankle Tomography with Stress Maneuvers|All diagnostic imaging exams and FAAM questionnaire will be applied in a standard way in both groups.
15843425|NCT04095585|Genetic|chromosomal microarray analysis (CMA) and whole exome sequencing (WES)|"The investigator evaluated the following hypotheses:
~i) atypically large 7q11.23 deletions including additional genes; ii) rare pathogenic variants in genes located within the deletion, in particular GTF2I iii) additional pathogenic copy number variants (CNVs) or rare intragenic pathogenic variants located in other chromosomal regions with various inheritance patterns (autosomal recessive, X-linked, de novo autosomal dominant); given the small number of patients recruited, we focused on rare exonic variants considered to be pathogenic according to the criteria of the American College of Medical Genetics and Genomics (ACMG)"
15843426|NCT04095572|Drug|intravesical instillation with HA-CS|intravesical instillation with HA-CS (Ialuril Prefill®, IBSA Farmaceutici Italia Srl, Lodi, Italy)
15843427|NCT04095572|Drug|intravesical instillation of sterile purified water|intravesical instillation of sterile purified water (packed and labelled according to Good Manufacturing Practice at IBSA Farmaceutici Italia Srl in Lodi, Italy to provide adequate blinding)
15843428|NCT04095559|Diagnostic Test|multipolar mapping catheter|mapping of the left atrium will be performed in sinus rhythm using the IntellaMap Orion multipolar mapping catheter (Boston Scientific).
15843429|NCT04095559|Diagnostic Test|multielectrode circular catheter|mapping of the left atrium will be performed using the multielectrode circular catheter (Lasso, spacing 2-6-2 mm, Biosense Webster)
15843430|NCT04095559|Diagnostic Test|irrigated ablation catheter|mapping of the left atrium will be performed using the irrigated ablation catheter (IntellaNav Mifi OI)
15843431|NCT04095546|Other|routine psychotherapy for Borderline Personality Disorder (BPD)|Routine psychotherapy as treatment for patients with Borderline Personality Disorder
15843432|NCT04095533|Other|Tibialis anterior muscle cross-sectional area assessment by ultrasound|"Assessed using bedside ultrasound with repeat assessments every second day up to 2 weeks of ICU admission, or until discharge from ICU to yield an overall rate of muscle area decline reported as a %/day average muscle atrophy rate.
~Tibialis anterior cross-sectional area assessments will be assessed by measurement ultrasound to both legs with portable bedside ultrasound. The cross sectional area will be measured in cm^2 at 5 cm distal to the lateral eminence of the tibial tuberosity along the muscle belly. Image processing will be performed at the bedside using features available on the ultrasound device. Muscle boundaries will be marked on the device and the cross-sectional area (computed from the perimetral contour of the muscle section) will be determined. This process will be repeated for two times for each leg."
15843433|NCT04095533|Other|Muscle strength assessment|Assessed using clinical bedside evaluation every second day with the Medical Research Council Sum Score. This is a clinical assessment of strength of 6 different muscle groups (shoulder abductors, elbow flexors, wrist extensors, hip flexors, knee extensors, and ankle dorsiflexors) on each side of the body and recorded as a score between 0 (flaccid) and 5 (full strength).
15843434|NCT04095520|Procedure|Laser Etching|Before the restorations, cavities will be etched Er:Cr YSGG laser with 4W output power, water pressure 95% and air pressure 60% with MGG6 tip with the spot size of 600 µm will be used.
15843435|NCT04095520|Procedure|Phosphoric acid etching|Before the restorations, cavities will be etched with %37 phosphoric acid for 15 seconds.
15843436|NCT04095507|Diagnostic Test|uterocervical angle|uterocervical angle is the angle between lower segment of uterus and cervix
15843437|NCT04095494|Behavioral|Nitrous oxide use|In order to evaluate the perception of the Nantes health students we wish to place an anonymous survey concerning their training, their knowledge of the legislative framework governing the use of EMONO and their personal and professional experience around nitrous oxide.
15843438|NCT04095481|Device|Obalon Navigation/Touch System|The NTS Compatible Obalon Balloon System does NOT require the use of radiographic verification prior to the inflation of the intragastric balloon
15843439|NCT04095468|Radiation|Preoperative Radio(Chemo)Therapy|Preoperative radiotherapy +/- chemotherapy, then surgery (total mesorectal excision) or watch-and-wait
15843440|NCT04095455|Procedure|pectoral nerves block group|ultrasound guided block of nerve supply of surgical site
15843441|NCT04095455|Drug|Ketamine plus magnesium group|Patients received 40 mg/kg of magnesium sulphate infusion in 100cc normal saline, as a bolus dose, in addition to 0.2mg/kg of ketamine as a bolus dose, 15 min before the induction of general anesthesia. This was followed by intraoperative continuous infusion of 10 mg/kg/h of magnesium sulphate combined with infusion of 0.1mg/kg/h ketamine that was started before skin incision and continued until completion of skin closure via infusion pump (Atom Syringe Pump S-1235).
15843442|NCT04095455|Drug|Control group|Normal saline infusion with similar rate and volume to KM infusion was used as a placebo.
15843443|NCT04095442|Drug|Cepacol|Twice-daily use of Cepacol per the manufacturer's guidelines
15843444|NCT04095442|Drug|Tom's Natural Mouthwash|Twice-daily use of Tom's Natural Mouthwash per the manufacturer's guidelines
15843445|NCT04095429|Behavioral|Expect Respect|Expect Respect is a 24 session curriculum designed to support middle school students to increase skills in emotion regulation, relationship skills, communication, and positive bystander intervention behaviors.
15843446|NCT04095429|Behavioral|Enhanced Usual Care|Participants will be connected via a warm referral to available individual behavioral health supports and resources in their community that can support them.
15843447|NCT04095416|Device|ACE compression wrap|Bilateral lower extremity ACE compression wraps
15843448|NCT04095403|Other|Tarp Assisted Cooling|Body cooling utilizing a tarp and water
15843449|NCT04095403|Other|passive cooling|Supine rest.
15843450|NCT04095390|Drug|Pyrotinib|400 mg
15843451|NCT04095390|Drug|SHR6390|125mg
15843452|NCT04095390|Drug|Letrozole|2.5mg
15843453|NCT04095390|Drug|Capecitabine|500mg
15843454|NCT04095377|Other|No intervention, this is a retrospective study.|No intervention, this is a retrospective study.
15843458|NCT04095351|Diagnostic Test|Pulmonary function test|Spirometry or plethysmography, measurement of diffusion capacity
15843459|NCT04095351|Diagnostic Test|Imaging|Thoracic ultrasound, HRCT as scheduled within routine clinical examinations, echocardiography
15843460|NCT04095351|Biological|Blood sampling|Standard laboratory test for CTDs as part of routine clinical examination
15843461|NCT04095338|Other|traditional rehabilitation|Each session will include 50 minutes of traditional physical rehabilitation therapy
15843462|NCT04095338|Other|virtual reality games intervention|Each session will include 30 minutes of traditional physical rehabilitation therapy followed by 20 minutes of robotic training by Tymo system (Tyromotion, Austria), a wireless platform for the balance and the postural control training that simulates floor walking and stairs climbing. Tymo system is connected to a screen and provides virtual reality games, adaptable to the functional capacity of the patient. Through the games proposed, the physiotherapist will decide to work in a dimension (antero-posterior or medio-lateral dimension) or in two dimensions (combining the antero-posterior and medio-lateral movements).
15843463|NCT04095338|Other|robotic treadmill intervention|Each session will include 30 minutes of traditional physical rehabilitation therapy followed by 20 minutes of robotic training by Walker view (TecnoBody, Italy), a treadmill equipped with a sensorized belt with eight load cells and a 3D camera.to detect length, speed and symmetry of the pace and load, range of the trunk, hips and knees. Patients will be asked to walk at a comfortable speed, while the physiotherapist will be able to work on different parameters such as step length, load distribution, and step height. The setting will take place taking into account the clinical conditions of each patient, customizing the intervention. The Walker View will offer visual and auditory feedback to the patient, so as to correct gait in real time.
15843464|NCT04095325|Device|Ultrasound guided erector spinae block|Group 2 (n: 50): those who underwent ESP block after propofol atropine induction and maintained with only 1 mg / kg / h propofol in anesthesia maintenance
15843465|NCT04095312|Procedure|Revo-i robotic surgery system (Model MSR-5100)|for evaluating the clinical safety and effectiveness of the automated robotic robot, Revo-i Surgical Robot System (Model MSR-5100), used for general HBP surgery
15843466|NCT04095312|Procedure|Revo-i robotic surgery system (Model MSR-5100)|for evaluating the clinical safety and effectiveness of the automated robotic robot, Revo-i Surgical Robot System (Model MSR-5100), used for general Uro surgery
15843467|NCT04095312|Procedure|Revo-i robotic surgery system (Model MSR-5100)|for evaluating the clinical safety and effectiveness of the automated robotic robot, Revo-i Surgical Robot System (Model MSR-5100), used for general colorectal surgery
15843468|NCT04095299|Radiation|50.4 Gy to the tumor and elective volume|Standard radiotherapy
15843469|NCT04095299|Radiation|62 Gy to the clinical tumor volume and 50.4 Gy to the elective volume|Experimental radiotherapy
15843470|NCT04095299|Drug|Capecitabine 825 mg/m2 twice daily on weekdays|Standard chemotherapy
15843471|NCT04095286|Drug|AMB new formulation (1 mg)|AMB tablets will be available at a unit dose strength of 1 mg. Participants will orally administer 5 tablets of 1 mg unit dose.
15843472|NCT04095286|Drug|Reference AMB (5 mg)|AMB reference tablet will be available as film-coated tablet at unit dose strength of 5 mg. Participants will orally administer 1 tablet of 5 mg unit dose
15843475|NCT04095260|Other|Pre-season strength and conditioning program|The structured physical performance assessment will include functional movement testing, motor coordination testing, joint mobility screen, muscle strength testing, and agility performance testing. These measures will assess the effectiveness of pre-season strength and conditioning program to reduce musculoskeletal impairments and increase resistance to injury.
15843476|NCT04095247|Device|Vagus nerv stimulator|pulse triggered autostimulation
15843477|NCT04095234|Procedure|Acupuncture|Acupuncture, a therapy of traditional Chinese medicine (TCM), involves penetrating the skin with thin, solid, metallic needles that are manipulated by hand or electrical stimulation. If the patient has an electronically charged device, they will not receive TENS stimulation.
15843478|NCT04095234|Procedure|Massage|Massage, which involves the manual manipulation of muscles and other soft tissue areas of the body, is one of the earliest known forms of pain relief.
15843479|NCT04095221|Drug|Prexasertib|"DOSE LEVELS FOR PATIENTS > 21 YEARS OF AGE, Dose Level -1, prexasertib 105 mg/ m2 once every 14 days in 28 day cycles Dose Level 0, 60 mg/m2 prexasertib once every 21 days Dose Level 1, (STARTING) 80 mg/m2 prexasertib once every 21 days Dose Level 2, 105 mg/m2 prexasertib once every 21 days Dose Level 3, 105 mg/m2 prexasertib once every 21 days
~DOSE LEVELS FOR PATIENTS ≤ 21 YEARS OF AGE Dose Level -1, prexasertib 150 mg/ m2 once every 14 days in 28 day cycles, Dose Level 0, 60 mg/m2 prexasertib once every 21 days, Dose Level 1, (STARTING) 80 mg/m2 prexasertib once every 21 days, Dose Level 2, 150 mg/m2 prexasertib once every 21 days, Dose Level 3, 150 mg/m2 prexasertib once every 21 days"
15843480|NCT04095221|Drug|Irinotecan|15 mg/m2 IV daily x 10 days in 21 day cycles
15843481|NCT04095208|Drug|Association of Nivolumab + Relatlimab|"A treatment cycle consists of 4 weeks.
~Nivolumab will be administered as a 30-minutes intravenous infusion, on Days 1 and 15 of each cycle (every 2 weeks) - [240 mg].
~Relatlimab will be administered as a 60-minutes intravenous infusion, on Days 1 and 15 of each cycle (every 2 weeks) - [80 mg]."
15843482|NCT04095208|Drug|Nivolumab|"A treatment cycle consists of 4 weeks.
~Nivolumab will be administered as a 30-minutes intravenous infusion, on Days 1 and 15 of each cycle (every 2 weeks) - [240 mg]."
15843483|NCT04095195|Radiation|MRCP|"Subjects fulfilling the radiological follow-up criteria will be submitted to MRCP or EUS according to the pancreatologist's prescription"
15843484|NCT04095195|Procedure|Endoultrasonography|"Subjects fulfilling the radiological follow-up criteria will be submitted to MRCP or EUS according to the pancreatologist's prescription"
15843485|NCT04095182|Drug|Zebinix 400mg|Zebinix 400mg group is administered with two Zebinix 200mg tablets per day. (Single dose: Day 1, Multiple dose: Day5~11)
15843486|NCT04095182|Drug|Placebo for Zebinix 400mg|"Placebo for Zebinix 400mg group is administered with two placebo for Zebinix 200mg tablets per day.
~(Single dose: Day 1, Multiple dose: Day5~11)"
15843487|NCT04095182|Drug|Zebinix 800mg|Zebinix 800mg group is administered with a Zebinix 800mg tablet per day. (Single dose: Day 1, Multiple dose: Day5~11)
15843488|NCT04095182|Drug|Placebo for Zebinix 800mg|"Placebo for Zebinix 800mg group is administered with a placebo for Zebinix 800mg tablets per day.
~(Single dose: Day 1, Multiple dose: Day5~11)"
15843489|NCT04095182|Drug|Zebinix 1600mg|Zebinix 1600mg group is administered with two Zebinix 800mg tablets per day. (Single dose: Day 1, Multiple dose: Day5~11)
15843490|NCT04095182|Drug|Placebo for Zebinix 1600mg|"Placebo for Zebinix 1600mg group is administered with two placebo for Zebinix 800mg tablets per day.
~(Single dose: Day 1, Multiple dose: Day5~11)"
15843491|NCT04095169|Diagnostic Test|Complement C3d test (blood sample)|Evaluation of C3d levels in EDTA samples from participants
15843492|NCT04095156|Diagnostic Test|In vitro assays.|Biochemical and flow-cytometry analysis of specimen collected.
15843493|NCT04095143|Diagnostic Test|Portal vein flow|Doppler assessment performed on day 0, 3 and 7.
15843494|NCT04095143|Diagnostic Test|Intra-renal flow|Doppler assessment performed on day 0, 3 and 7.
15843495|NCT04095143|Diagnostic Test|Hepatic vein flow|Doppler assessment performed on day 0, 3 and 7.
15843496|NCT04095143|Diagnostic Test|Pulmonary B-lines|Ultrasound assessment of performed on day 0, 3 and 7.
15843497|NCT04095143|Diagnostic Test|Dimensions of the inferior vena cava|Ultrasound assessment of performed on day 0, 3 and 7.
15843498|NCT04095143|Diagnostic Test|Left ventricular function|Ultrasound assessment of performed on day 0, 3 and 7.
15843499|NCT04095143|Diagnostic Test|Right ventricular function|Ultrasound assessment of performed on day 0, 3 and 7.
15843500|NCT04095130|Diagnostic Test|23Na Magnetic resonance imaging|Measurement of skin sodium content by non-invasive 23Na Magnetic resonance imaging.
15843501|NCT04095117|Procedure|Epidural block|"Epidural catheter will be inserted at the L3-L4 or L4-L5 interspace in obese subjects scheduled for surgery on the lower extremities under epidural anesthesia.
~The sagittal abdominal diameter, BMI and skin to epidural space distance will be recorded."
15843502|NCT04095104|Drug|Phentermine|Phentermine tablet
15843503|NCT04095104|Drug|Immediate Release Topiramate|Topiramate tablet
15843504|NCT04095104|Drug|Placebo for Phentermine|Compounded tablet to mimic phentermine 8mg tablet
15843505|NCT04095104|Drug|Placebo for Immediate Release Topiramate|Compounded tablet to mimic immediate release topiramate 25mg tablet
15843506|NCT04095091|Device|4D Planar US Transducer|This 4D planar US transducer is being developed and validated to provide a novel image-guidance technique to directly track tumor motion during radiation therapy that is coupled to a pre-treatment calibration training image set consisting of a simultaneous 4D ultrasound and 4D magnetic resonance imaging (MRI) acquisition.
15843507|NCT04095078|Device|SIMEOX|Use without obligation, in autonomous and at home of the bronchial clearance device: SIMEOX
15843508|NCT04095065|Behavioral|itMatters|Increase knowledge related to STIs, STI risk, alcohol impairment, condom use, alcohol use behavior tracking skill, testing & treatment knowledge. Correct misperceptions regarding approval (injunctive norms) and prevalence (descriptive norms) of alcohol misuse & sexual risk taking.
15843509|NCT04095065|Behavioral|itMatters and itMatters Sexual Violence Prevention|Increase knowledge related to STIs, STI risk, alcohol impairment, condom use, alcohol use behavior tracking skill, testing & treatment knowledge. Correct misperceptions regarding approval (injunctive norms) and prevalence (descriptive norms) of alcohol misuse & sexual risk taking. Additionally, increased knowledge related to sexual violence (prevalence, key definitions, individual rights and responsibilities, laws) and increased knowledge, efficacy, and intentions to use bystander behaviors during moments of sexual violence.
15843510|NCT04095065|Behavioral|itMatters Well-being and itMatters Sexual Violence Prevention|Increase knowledge related to sleep, including biological effects of sleep and sleep hygiene. Increase knowledge related to time management, including important definitions, sleep management strategies, and effective time management routines. Additionally, increased knowledge related to sexual violence (prevalence, key definitions, individual rights and responsibilities, laws) and increase knowledge, efficacy, and intentions to use bystander behaviors during moments of sexual violence.
15843511|NCT04095065|Behavioral|itMatters Well-being|Increase knowledge related to sleep, including biological effects of sleep and sleep hygiene. Increase knowledge related to time management, including important definitions, sleep management strategies, and effective time management routines.
15843512|NCT04095052|Dietary Supplement|Methyl Folate|1,000 mcg methyl folate and Microcrystalline Cellulose in a capsule
15843513|NCT04095052|Dietary Supplement|Placebo|Microcrystalline Cellulose capsule
15843514|NCT04095039|Procedure|Hemodialysis|Patients in both arms will undergo hemodialysis to remove phosphate from the blood; however, patients in the Hi Arm will only be titrated down to no lower than 6.5mg/dl
15843515|NCT04095013|Drug|Bupivacaine, fentanyl|Group A: hyperbaric Bupivacaine 10mg with fentanyl 10micrograms,
15843516|NCT04095013|Drug|Bupivacaine, dexmedetomidine|Group B: hyperbaric Bupivacaine 10 mg with dexmedetomidine5 micrograms
15843517|NCT04095000|Behavioral|FACE-TC SP|The current FACE-TC protocol consists of three weekly 60 to 90-minute sessions in a dyadic format facilitated by a trained/certified interviewer. If our community partners recommend otherwise, this structure could change. Each session is followed by a 10-minute assessment, using process measures to assess participants' ratings of the quality of communication and satisfaction.
15843518|NCT04095000|Behavioral|Treatment as Usual|Treatment as Usual comparison condition will also be assessed and measures administered at the same time intervals.
15843519|NCT04094987|Device|inter-fascial pressure|The pressure between the fascia and the pressure line added to the catheter tip will be measured.
15843520|NCT04094974|Device|ANSiscope|Heart rate variability will be assessed using ansiscope before surgery
15843521|NCT04094961|Drug|Ixazomib|Oral, administered four times per cycle
15843522|NCT04094961|Drug|Pomalidomide|Oral, administered 14 times per cycle
15843523|NCT04094961|Drug|Dexamethasone|Oral, fixed dose administered 8 times per cycle
15843524|NCT04094948|Drug|Clenbuterol|20 mcg spiropent tablets will be overencapsulated (two 20 mcg tablets per capsule)
15843525|NCT04094948|Drug|Placebos|dextrose-filled capsules
15843526|NCT04094922|Behavioral|Swedish PTSD Coach smartphone app|Self-help smartphone app targeted towards posttraumatic stress that includes psychoeducation, rating/monitoring of distress, lists of support and treatment resources, and strategies for coping with distress.
15843527|NCT04094909|Drug|Rh-endostatin|"Squamous NSCLC: Rh-endostatin+Pembrolizumab+carboplatin or cisplatin +[nab]-paclitaxel during the treatment. Rh-endostatin+Pembrolizumab during the maintenance period.
~Non-squamous NSCLC: Rh-endostatin+Pembrolizumab+carboplatin or cisplatin +pemetrexed during the treatment. Rh-endostatin+Pembrolizumab + pemetrexed during the maintenance period."
15843528|NCT04094896|Drug|TCHP|Both TCHP (docetaxel/carboplatin/trastuzumab/Pertuzumab) and EC followed by THP(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab/Pertuzumab)regimens as Neoadjuvant Treatment for HER2-Positive Breast Cancer have been recommended by NCCN guideline. It is unknown which regimen is better. This study is to evaluate the efficacy and safety ofTCHP (docetaxel/carboplatin/trastuzumab/Pertuzumab) and EC followed by THP(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab/Pertuzumab)regimens as Neoadjuvant Treatment in HER2- Positive breast cancer. The endpoint of pathologic complete response is used as a surrogate marker for survival. Safety and tolerability assessed by number of grade 4 toxicities and hospitalizations.
15843529|NCT04094883|Biological|Meningococcal Group B Vaccine|All participants will receive the 4CMenB vaccine, 0.5 mL, at entry (Day 0) and at week 5.
15843530|NCT04094870|Drug|Sertraline|daily SSRI (Sertraline 25mg)
15843531|NCT04094870|Behavioral|Interpersonal therapy|11 sessions over a 24-week period
15843532|NCT04094857|Drug|HBN-1|Intravenous infusion
15843533|NCT04094844|Other|Wearable activity sensor|Caregivers and patients in both arms of the study will have a Fitbit wearable activity sensor to track activity and sleep.
15843534|NCT04094844|Behavioral|Roadmap 2.0 information system|Caregivers and patients download the Roadmap 2.0 app on their mobile phones
15843535|NCT04094844|Other|Survey administration|Caregivers and patients will be asked to respond to survey questions at 3 timepoints.
15843536|NCT04094844|Behavioral|Roadmap 2.0 information system with Positive Activities|Caregivers and patients download the Roadmap 2.0 app on their mobile phones. Caregivers and patients will be instructed on how to operate Roadmap 1.0 on an iPad (inpatient only) and Roadmap 2.0 on a mobile phone (inpatient and outpatient). Caregivers download the Positive Activities app onto their mobile phone to use freely throughout inpatient and outpatient (through day 120 post-transplant). Caregiver may also use an electronic tablet provided by the study team during the patient's hospital stay.
15843537|NCT04094831|Other|Health education|The intervention group will receive health education through CKD campaign and mHealth technology. During the half day CKD campaign, health education materials (leaflet and short textbook and recording notebook) will be provided to the study participants. A nephrologist will facilitate the campaign and contents (Annex-3) of the text book and leaflet (Annex-4) will be discussed. Important message from the text book (such as stage, risk factor, preventive measures) will be used to develop the leaflet. In addition,Basic health education information about CKD is included in the contents to help patients gain knowledge, awareness, and improve their behaviors. Discussion on basic kidney diseases, risk factors, and preventive measures of CKD is performing by CHWs over a mobile phone call to the study patients. The patients have the liberty to discuss their health-related issues with the CHWs over a period of 10 minutes
15843538|NCT04094818|Diagnostic Test|HostDx Sepsis|Blood collection for mRNA analysis, Procalcitonin and CRP determination, molecular analysis of nasopharyngeal swab collection
15843539|NCT04094805|Drug|Rocaltrol|Rocaltrol 0.25 μg daily for 1 month; HD-DXM (orally at 40 mg daily for 4d )
15843540|NCT04094805|Drug|Dexamethasone|HD-DXM (orally at 40 mg daily for 4d )
15843541|NCT04094792|Device|Happify Breather App|Subjects in the intervention group will be cued to breathe at 6 breaths per minute and will receive real time heart rate variability biofeedback. As they increase HRV, screen elements will become more visually appealing.
15843542|NCT04094779|Other|Usual relation care|When a patient begins to agitate, he will be isolated from the group to establish a dual relationship where the caregiver will try through his relational approach to calm the agitation.
15843543|NCT04094779|Other|"Flash activity breath of fresh air"|When a patient begins to agitate , he will be isolated from the group and the patient leave from the unit to walk outside with the caregiver.
15843544|NCT04094766|Drug|Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy|Patients will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of CAR-T cells. After a pre-treatment lymphodepletion therapy, patients will receive the Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy by intravenous injection.
15843545|NCT04094753|Diagnostic Test|Blood Sample|A sober blood sample is taken to observe the following parameters: creatinin, ureum, sodium, potassium, osmolality, HDL cholesterol, LDL cholesterol, triglycerides)
15843546|NCT04094753|Diagnostic Test|Renal Function Profile|A Renal Function Profile is a 24 hour-urine collection in which urine samples are collected at fixed time points every 3 hours, starting 3 hours after the first morning void. Daytime samples were taken at 10:00-11:30 (U1), 13:00-15:30 (U2), 16:00-17:30 (U3), 19:00-20:30 (U4), and 22:00-23:30 (U5). The nighttime samples were taken at 1:00-2:30 (U6), 4:00-5:30 (U7) and 7:00-8:30 (U8). The volume of each sample, and of each micturition in between, was noted to calculate the 24h, daytime and nighttime urine volume and diuresis rate.
15843547|NCT04094753|Diagnostic Test|Frequency Volume Chart|Every patient complets a frequency volume chart during 24 of 72 hours
15843548|NCT04094753|Diagnostic Test|Cystometry|This technique provide the most precise measurement of bladder and urethral sphincter behaviour during bladder filling and during voiding.
15843549|NCT04094753|Diagnostic Test|Questionaires|"Patients have to fulfill the following questionaires
~ICIQ-Fluts for female participants or ICIQ-Mluts for male participants
~TILBURG FRAILTY INDICATOR
~SF-36 Quality of Life score
~N- QOL"
15843550|NCT04094753|Diagnostic Test|Flow rate measurement + Observation of the post-void residual urine volume|A measurement of the urinary flow rate is observed to collect the maximum Q/s. Afterwards an observation of the PVR is done using ultrasound.
15843551|NCT04094753|Diagnostic Test|Clinical Examination|Clinical examination of the genital region. For women, coeles are described using the POPQ
15843552|NCT04094740|Device|Jet Injector without A Needle|Patients in the experimental group will use a needle - free jet injector to inject insulin, which delivers insulin at a high velocity into subcutaneous tissue and dispenses insulin over a larger area than a syringe.
15843553|NCT04094727|Drug|Presumptive treatment with Artemether-lumefantrine (AL)|All eligible HRPs will be presumptively treated with artemether-lumefantrine (AL) at two timepoints, separated by at least one month. All individuals who have provided informed consent, meet eligibility criteria, are not pregnant or breastfeeding, and who do not have symptoms associated with severe malaria or another severe illness, will be offered an age-appropriate course of AL (age-specific blister packages). AL is currently the first line drug used for uncomplicated malaria in Namibia, and has been used previously in northern Namibia for focal mass drug administration and has no severe adverse effects and is well-tolerated, with high adherence and acceptability in this context. AL requires two daily doses for three consecutive days, for a total of six doses. The first antimalarial dose will be delivered by directly observed therapy (DOT) and subsequent doses will be left with the subject, with instructions to self-administer them.
15843554|NCT04094727|Other|Enhanced vector control|"The mop up indoor residual spraying (IRS) campaign will be targeted to farms and cattle posts/kraals in intervention areas in December 2019 to fill gaps from the routine spray campaign (September to November 2019) and utilize the same insecticides and protocols as the national campaign. The team will spray each unsprayed structure with the recommended solution of dichloro-diphenyl-trichloroethane (DDT) for traditional structures and/or Actellic for modern structures, tarps and tents.
~Alternative vector control interventions, including LLINs (long-lasting insecticide treated bed nets), sprayed tents/tarps and topical repellents will be distributed to eligible HRPs between November and January 2020 during one round."
15843555|NCT04094701|Other|Control Group Regimen|Norco (hydrocodone-acetaminophen) 5mg-325mg, 30 total pills. This is the standard of care prescribing procedure for pain management after hip arthroscopy.
15843556|NCT04094701|Other|Opioid reduced regimen|Tylenol extra strength (1000 mg, three times daily for 10 days following surgery), Gabapentin (300 mg at night for 10 days following surgery) and Norco (hydrocodone-acetaminophen) 5mg-325mg, 5 total pills
15843557|NCT04094688|Drug|Bevacizumab|Given IV
15843558|NCT04094688|Drug|Oxaliplatin|Given IV
15843559|NCT04094688|Drug|Leucovorin Calcium|Given IV
15843560|NCT04094688|Drug|Fluorouracil|Given IV
15843561|NCT04094688|Drug|Irinotecan Hydrochloride|Given IV
15843562|NCT04094688|Drug|Irinotecan|Given IV
15843563|NCT04094688|Dietary Supplement|Cholecalciferol|Given PO
15843564|NCT04094688|Other|Quality-of-Life Assessment|Ancillary studies
15843565|NCT04094688|Other|Questionnaire Administration|Ancillary studies
15843566|NCT04094675|Drug|Sirolimus|Use of sirolimus 2 mg by mouth daily for 1 year
15843567|NCT04094662|Drug|Mirogabalin|Mirogabalin tablets for oral administration
15843568|NCT04094662|Drug|Placebo|Matching placebo tablets for oral administration
15843569|NCT04094649|Device|Ultrasound Vagus Nerve Stimulation (DECIMA)|This is a single-site, double-blind, randomized, prospective, sham-controlled, crossover early feasibility study to determine whether ultrasound Vagus Nerve Stimulation (uVNS) inhibits postprandial hyperglycemia in humans.
15843570|NCT04094636|Behavioral|In-bed cycling|Patients will daily perform 30 min of supervised in-bed cycling
15843571|NCT04094636|Behavioral|Exercise booklet|Patients will daily perform 30 min of supervised physical training with exercises from the exercise booklet
15843572|NCT04094623|Other|Dialectical behavior therapy|15 patients in a group are treated by 2 psychotherapist by DBT including mindfulness skills, distress tolerance skills, emotional regulation skills and interpersonal effectiveness skills.
15843573|NCT04094623|Other|Social support group therapy|15 patients in a group are treated by 2 psychotherapist by SSGT.(Giving support to each other.)
15843574|NCT04094610|Drug|Oral repotrectinib (TPX-0005)|Oral repotrectinib (TPX-0005)
15843575|NCT04094597|Drug|Lactoferrin|lactoferrin is given orally in comparsion to placebp
15843576|NCT04094597|Drug|Placebos|placebp is given in 2 ml saline
15843577|NCT04094584|Drug|Vivitrol (Extended Release Naltrexone)|Monthly Injection of 380mg Extended-Release Naltrexone
15843578|NCT04094571|Device|Functional Electrical Stimulation (FES) Control Protocol|To measure the delay, the motor will take the tricycle crank to pre-specified angles and then hold that position while various combinations of the quadriceps femoris and the gluteal muscle groups are stimulated in study participants.
15843579|NCT04094571|Device|Functional Electrical Stimulation (FES) Angle Protocol|To determine the effect of the crank angle on the FES delay and the muscle control effectiveness, the crank is positioned at a pre-specified angle, with various muscle groups being stimulated while holding this position. The motor then takes the crank to another angle and the process is repeated.
15843580|NCT04094558|Device|Ingestible capsule|Participants will swallow capsule and undergo X-rays to establish transit.
15843581|NCT04094532|Drug|Bupivacaine|Ultrasound guided 20 ml % 0.250 bupivacaine injection to transverse thoracic muscle plane bilaterally
15843582|NCT04094532|Drug|Saline|Ultrasound guided 20 ml % 0.9 saline injection to transverse thoracic muscle plane bilaterally
15843583|NCT04094519|Drug|enzalutamide|oral
15843584|NCT04094519|Drug|enzalutamide Placebo|oral
15843585|NCT04094519|Drug|digoxin|oral
15843586|NCT04094519|Drug|rosuvastatin|oral
15843588|NCT04094493|Drug|vit D|preoperative intra muscular vit D injection
15843589|NCT04094480|Device|polymeric non absorbable clips|a method to secure appendicular stump
15843590|NCT04094480|Other|endoloops|a method to secure appendicular stump
15843591|NCT04094467|Drug|Cetrorelix|0.25 mg subcutaneous injection daily for 6 days
15843592|NCT04094467|Drug|Leuprolide Acetate|0.1 mg subcutaneous injection daily for 12 days
15843593|NCT04094454|Device|special tampon with a diameter of 28mm|patients will use a special tampon with extended vaginal dilatation (diameter 28mm) during radiotherapy
15843594|NCT04094454|Device|standard tampon with a diameter of 12-13mm|patients in Arm B will use a normal commercially available tampon (diameter 12-13mm) during radiotherapy
15843596|NCT04094415|Drug|Semaglutide|Patients will be treated with commercially available semaglutide in a prefilled pen injector (FlexTouch® variant) according to routine local clinical practice at the discretion of the treating physician. Other anti-hyperglycaemic treatments will be prescribed at the physician's discretion.The decision to initiate treatment with semaglutide is at the treating physician's discretion, and clearly separated from the decision to include the patient in the study.
15843597|NCT04094402|Other|None. It is an observational study|None. It is an observational study
15843598|NCT04094389|Other|Orthotic continuous wear group|"Performed exclusively for research purposes, participants will be assigned at entrance to the study to either wear the orthotic continuously, only during waking hours, or only while sleeping. There will be three participants in each of the three groups.
~Participants in the continuous wear group will be instructed to wear their orthotic continuously around the clock as tolerated with removal for hygiene and home exercise program (HEP) performance. Consistent with standard of care for the treatment of trigger finger with an orthotic, all nine of the participants will be instructed to wear their orthotic for at least six weeks, as tolerated, with continuation of orthotic wear up to 10 weeks if their triggering has not completely abated."
15843599|NCT04094389|Other|Orthotic wear during waking hours only group|"Performed exclusively for research purposes, participants will be assigned at entrance to the study to either wear the orthotic continuously, only during waking hours, or only while sleeping. There will be three participants in each of the three groups.
~Participants in the waking hours only group will be instructed to wear their orthotic during all waking hours as tolerated, with removal for hygiene, HEP performance, but not at night while sleeping. Consistent with standard of care for the treatment of trigger finger with an orthotic, all nine of the participants will be instructed to wear their orthotic for at least six weeks, as tolerated, with continuation of orthotic wear up to 10 weeks if their triggering has not completely abated."
15843600|NCT04094389|Other|Orthotic wear only while sleeping group|"Performed exclusively for research purposes, participants will be assigned at entrance to the study to either wear the orthotic continuously, only during waking hours, or only while sleeping. There will be three participants in each of the three groups.
~In the night-wear group, participants will be told to wear their orthosis only at night. Consistent with standard of care for the treatment of trigger finger with an orthotic, all nine of the participants will be instructed to wear their orthotic for at least six weeks, as tolerated, with continuation of orthotic wear up to 10 weeks if their triggering has not completely abated"
15843601|NCT04094376|Other|receiving operation during the day or at night|eighty-four patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were randomly assigned to receive operation in the Day Group (8:00-12:00) and the Night Group (18:00-22:00)
15843602|NCT04094363|Other|Product A|Usual Brand, filtered combustible cigarette
15843603|NCT04094363|Other|Product B|CSD1902-11, an electronic nicotine delivery system
15843604|NCT04094363|Other|Product C|CSD1902-21, an electronic nicotine delivery system
15843605|NCT04094363|Other|Product D|4mg Nicotine gum
15843606|NCT04094350|Other|ACF with a seed-and-recruit model|The intervention will take place for 12 months. In the intervention clusters, potential seeds - TB survivors, people living with HIV, and household contacts of people with TB - will be approached by the research team. Seeds will be trained and act as recruiters in the community to refer presumptive TB cases to the attached health centers. The research team will work with staff at the health centers to facilitate screening and enrollment of recruits who are diagnosed with TB to care. New people with TB who have the potential to be a recruiter will be invited and trained to recruit their peers in the community who may have TB for TB screening. Seeds will be trained to identify people who may have TB and equipped with health promotion skills to impart knowledge and practices about TB. We will follow-up all people with TB referred by seeds for six months from the treatment initiation.
15843607|NCT04094350|Other|ACF targeting household and neighborhood contacts|In this arm, community health volunteers will recruit household contacts of people with TB and TB survivors diagnosed during the preceding two years. Immediate neighbors (10 nearest households) of the index cases (people with TB) who are symptomatic will also be invited by the community health volunteers to the screening session. Next nearest households within the same village will be approached if the number of presumptive TB cases in the 10 nearest households is low. The one-off screening session will be held at the nearest health center on specific days. Presumptive TB cases will be screened for symptoms on-site, and chest x-ray (CXR) will be taken. Sputum samples from presumptive TB cases with abnormal (CXR) will be collected for GeneXpert testing. Test results will be communicated to the newly diagnosed people with TB, and they will be referred to the health centers for treatment and follow-up.
15843639|NCT04094051|Drug|Ibrutinib|In the retrospective period, clinical information of approximate 500 patients with CLL/SLL prior to the study initiation will be collected retrospectively through chart review. There will be one time follow-up to collect data on disease progression, survival status and patient-reported outcomes.
15843640|NCT04094038|Drug|Olimel N12|A mixture of glucose, lipids, amino acids.
15843608|NCT04094350|Other|ACF targeting the older population using mobile screening units|The outreach team will conduct training and sensitization of the target population of the activities. The schedule of a one-off screening session will be made known to the communities in the districts before the screening day. Each person who visits the screening session will be screened. Demographic information and presence of TB symptoms will be collected at registration by a trained staff. A chest x-ray will then be performed on-site for all persons exhibiting TB symptoms and all elderly aged 55 and above regardless of symptoms. When CXR findings are abnormal, sputum samples will be collected for GeneXpert testing on-site as well. Test results will be communicated to the participants on the spot or via phone calls, and people with TB will be referred for treatment and follow-up at the health center where screening is conducted or a center of their choice. Should the health center of their choice do not fall within the selected sites, follow-up will be conducted via phone calls.
15843609|NCT04094350|Other|Passive case finding|Passive case finding (PCF) strategy is a default setup in the national health system. PCF relies on the self-presentation of presumptive TB cases to the health centers to be diagnosed with TB.
15843610|NCT04094337|Behavioral|Internet-assisted treatment|Internet-assisted treatment
15843611|NCT04094324|Behavioral|Questionnaires|4 questionnaires will be answered via iPads
15843612|NCT04094311|Biological|Tisagenlecleucel|A single intravenous (i.v.) infusion of CAR-positive viable T cells.
15843613|NCT04094298|Drug|FX006 Injection|One injection of extended release triamcinolone. 32 milligram injection of the extended release triamcinolone in a 75:25 ratio of polylactic-co-glycolic acid (PLGA) microspheres to drug load of 25%. The drug product is reconstituted with diluent containing an isotonic, sterile aqueous solution of sodium chloride, carboxymethylcellulose sodium and polysorbate-80 to form a suspension prior to injection.
15843614|NCT04094285|Drug|SAUERSTOFF|"SAUERSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria
~Dose:
~min. 95.5%, breathing for 30 minutes"
15843615|NCT04094285|Drug|STICKSTOFF|"STICKSTOFF medizinisch, Messer GmbH, Industriestrasse 5, 2352 Gumpoldskirchen, Austria
~Dose:
~88% with 12% oxygen, breathing for 30 minutes"
15843616|NCT04094272|Diagnostic Test|transthoracic doppler-echocardiography (TTE)|Transthoracic doppler-echocardiography (TTE) in patients with a new diagnosis of HCV before and after treatment with DAA medication.
15843617|NCT04094259|Behavioral|Questionnaire.|patients will respond to a specific questionnaire regarding the use of alternative medicine
15843620|NCT04094233|Dietary Supplement|Beetroot extract|Ingestion of 600mg beetroot extract two hours before strength exercise (75% 1RM).
15843621|NCT04094233|Other|Placebo|Ingestion of 600mg starch two hours before strength exercise (75% 1RM).
15843622|NCT04094220|Procedure|Lateral lumbar interbody fusion|LLIF is an indirect decompression technique, and does not directly remove the disc or osteophyte protruding into the spinal canal. Its decompression effect is not as thorough as traditional posterior decompression surgery. Usually, posterior decompression is required for patients who have unsuccessful indirect decompression.
15843623|NCT04094207|Drug|Placebo oral tablet|Placebo tablets PLUS Risperidone 2 mg tablet up to 6 mg/day
15843624|NCT04094207|Drug|Pentoxifylline|Pentoxifylline tablet PLUS Risperidone 2 mg tablet up to 6 mg/day
15843625|NCT04094194|Other|Nordic diet|Healthy dietary pattern that is consumed in Nordic countries
15843626|NCT04094168|Drug|DEL NIDO CARDIOPLEGIA|"Del Nido components: Plasmalyte 148 (1000 ml), NaHCO3 8.4% 1M (13 ml), MgSO4 0,5 M (16,5 ml), Mannitol 20% (16,3 ml), KCl 2 M (13 ml), Lidocaine 2% (6,5 ml).
~Electrolytic composition (l000 ml): Na+ 153 mEq, K+ 31 mEq, Cl - 124 mEq, Mg2+ 19,5 mEq, NaHCO3 13 mEq, Acetate 27 mEq, Sulfate 16,5 mEq, Gluconate 23 mEq."
15843627|NCT04094168|Drug|COLD BLOOD BASED CARDIOPLEGIA|Cardibraun components: Electrolytic composition (1000 ml): Na+ 185,8 mmol, K+ 24,1 mmol, Cl- 192,8 mmol, Acetate 23 mmol, Fosfate 0,97 mmol, Citrate 6,32 mmol.
15843628|NCT04094155|Diagnostic Test|retinal vascular analysis|Retinal fundoscopy over a 3 week period in stationary patients after aneurysmatic subarachnoid hemorrhage
15843629|NCT04094142|Drug|Acalabrutinib|"Acalabrutinib, lenalidomide, rituximab will be given as described in the Arms decriptions. Day 1 to day 28 is considered one cycle, and cycles will be repeated every 4-weeks, for 6 cycles.
~After 6 cycles, maintenance of acalabrutinib 100mg bid will be administered up to 1 year for subjects whose best responses- to the regimen are partial response or complete remission."
15843630|NCT04094129|Dietary Supplement|Wismemo|Multi-strain probiotic supplement includes Lactobacillus reuteri GMNL-89, Lactobacillus paracasei GMNL-133 and Lactobacillus plantarum GMNL-141.
15843631|NCT04094129|Dietary Supplement|Placebo|placebo
15843632|NCT04094116|Procedure|ear wax syringing without pre ear oil treatment|Active Comparator: ear wax syringing with pre ear oil treatment Sham Comparator: ear wax syringing without pre ear oil treatment
15843633|NCT04094103|Dietary Supplement|Active strawberry powder|Participants will drink a strawberry beverage with active ingredients once a day during the 4-week intervention period.
15843634|NCT04094103|Dietary Supplement|Placebo strawberry powder|Participants will drink a strawberry placebo beverage once a day during the 4-week intervention period.
15843635|NCT04094103|Dietary Supplement|Mixed strawberry powder|Participants will drink a mixed strawberry beverage with active ingredients and placebo once a day during the 4-week intervention period.
15843636|NCT04094090|Combination Product|PXL-330 Platinum device for crosslinking with Peschke riboflavin solution|Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea
15843637|NCT04094077|Drug|AGuIX|2 IV injections (100 mg/Kg/injection) at day 4 and day 8 + Strereotactic Radiation from day 8 to day 15 as per standard practice.
15843638|NCT04094064|Device|Continuous Glucose Monitor|Use of a continuous glucose monitor during study period.
15843641|NCT04094038|Drug|Glucose IV|Glucose 5%
15843642|NCT04094025|Drug|dATS|d-Amphetamine Transdermal System
15843644|NCT04093999|Procedure|Sensory nerve coaptation|A recipient sensory nerve branch of the 11th-12th intercostal nerve was reattached to a donor nerve in the chest area. The anterior cutaneous branch of the second or third intercostal nerve was used as the donor nerve. Direct, end-to-end nerve coaptation was performed.
15843645|NCT04093986|Other|Chart Review|Medical records or data available from previous clinical care prior to June 20, 2019 about pregnancy and breastfeeding outcomes, both for babies with hydroxyurea exposure and other babies by these same women.
15843646|NCT04093986|Other|Survey|Women who choose to participate directly and provide information in survey format will receive a brief survey and the option to upload their medical records (if available) into Cincinnati Children's maintained REDCap database.
15843647|NCT04093973|Diagnostic Test|bicycle stress echocardiography|Study subjects will perform supine bicycle exercise with echocardiography performed before, during, and after exercise. Definity (perflutren microbubble contrast agent) will be used as needed to enhance echo images.
15843648|NCT04093960|Dietary Supplement|Lactobacillus plantarum PS128|10 mg qd of escitalopram qd plus 300mg bid of Lactobacillus plantarum PS128 to enhance antidepressive effect
15843649|NCT04093947|Other|Observational study|Observational and prospective study
15843650|NCT04093934|Behavioral|Psychosocial stimulation|Children will receive fortnightly sessions of psychosocial stimulation and nutritional support for one year during the study period.
15843651|NCT04093921|Behavioral|MET-based therapy|see previous
15843652|NCT04093921|Behavioral|Standard Care|To include all recommended outpatient treatments
15843653|NCT04093908|Other|Prediction of motor outcome after STN DBS based on preoperative variables|Generating individual probabilities for motor response based on preoperative variables
15843654|NCT04093895|Drug|PerioSept(r)|Scaling and root planing followed by 3% PerioSept(r) administration
15843655|NCT04093882|Diagnostic Test|Contrast agent enhanced MRI using Gadovist|By using the contrast agent Gadovist we aim to visualize the blood-brain barrier. Furthermore, we aim to measure a newly developed biomarker of the blood-brain barrier in the cerebro-spinal fluid.
15843656|NCT04093869|Behavioral|Coping Skills Training combined with Exercise (CSTEX)|The CSTEX condition has two integrated components: the CST component will systematically train patients in the use of coping skills for stress reduction and promote key transplant-specific health behaviors. The exercise component of the intervention will progressively increase participants exercise and promote daily physical activity through motivational interviewing strategies.
15843657|NCT04093869|Behavioral|Standard of Care plus Education (SOC-ED)|The SOC-ED condition provides support and enhanced post-transplant education. Participants will be given detailed educational information about post-transplant care, the importance of medication adherence, and maintenance of physical activity.
15843658|NCT04093843|Device|TMS|NeuroStar TMS Therapy
15843659|NCT04093830|Device|hearing aid|hearing aid can be used in their non- implanted ear with residual hearing
15843660|NCT04093817|Device|cardio pulmonary bypass machine|cardio pulmonary bypass machine is a machine that work to compensate for the function of the heart and the lungs in the operation
15843661|NCT04093804|Device|Glenosphere size for Reverse Shoulder Arthroplasty|Two randomized study groups will be formed with the consented patients (experimental and control). All patients will undergo reverse shoulder arthroplasty by the Principal Investigator. The experimental group patients will receive a 36mm glenosphere and the control group will receive a 32mm glenosphere. All other procedures during the surgery are identical between groups.
15843662|NCT04093791|Behavioral|"Collective Intervention G"|"The steps are:
~Listening/establishing relationship. This step is characterized by listening and understanding the critical points from the new mothers. The operator maintains a nonjudgmental approach encouraging the women to describe the need for behavioral change.
~Analysis. The situation must be carefully evaluated, considering the discomfort and emotional distress. The stress situation will be described in a subjective way and they will assign a grade of discomfort for each problem.
~Assessment. The operator will carry out a multidimensional evaluation of the mothers within the dyad. The operator will evaluate the strategies implemented by the mothers to face problems and the reasons of the failures.
~Summary and goal of the intervention. The problems detected by the operator will be explained and summarized to the participants. The operator explores ways to implement change."
15843663|NCT04093791|Behavioral|"Individual Intervention I"|"The steps are:
~Listening/establishing relationship. This step is characterized by listening and understanding the critical points from the new mother. The operator maintains a nonjudgmental approach encouraging the woman to describe the need for behavioral change.
~Analysis. The situation have be carefully evaluated, considering the discomfort and emotional distress. The stress situation will be described in a subjective way, and she will assign a grade of discomfort for each problem.
~Assessment. The operator will carry out a multidimensional evaluation of the mothers within the dyad. The operator will evaluate the strategies implemented by the mother to face problems and the reasons of the failures.
~Summary and goal of the intervention. The problems detected by the operator will be explained and summarized to the participants. The operator explores ways to implement change."
15843664|NCT04093778|Other|Low dose high frequency training and Safe Delivery Phone Application|The intervention period is a 9-month period where we will facilitate a quality improvement cycle using Low Dose High Frequency training with the Safe Delivery App as an anchor point and facilitate the integration into clinical practice through our Safe Delivery Focal Points at each hospital. All staff in maternity, paediatric wards and outpatient clinics will receive training and be encouraged to use the Safe Delivery App on a weekly basis.
15843665|NCT04093765|Diagnostic Test|Ultrasensitive Rapid Diagnostic Test (URDT)|"Investigation will consist in 1 URDT.
~For P. falciparum URDT positive:
~collection of 3x1cm dried blood spots on filter paper
~administration of a supervised antimalarial treatment course to individuals for which a P. falciparum will have been detected by URDT.
~Specifically in group 1, a population list will be collected in each village prior to MSAT campaign and all participants will undergo:
~collection of a 200 µL-aliquot of capillary blood for each participant to the screening during the MSAT intervention.
~1 URDT + collection of a 200µL-aliquot of capillary blood for each participant to the follow-up survey at M12."
15843666|NCT04093765|Drug|Antimalarials|"A safe, recommended treatment of P. falciparum malaria will be administered to URDT positive individuals based on participant's characteristics:
~The standard regimen for participants without known antimalarial allergy, not pregnant and not breastfeeding, will be a 3-day supervised weight-adjusted DP course and a single low dose PMQ. The single low dose PMQ will be administered on the first day.
~Pregnant women and in their 2nd or 3rd trimester, and breastfeeding mothers, will receive a DP course but no PMQ.
~Pregnant women in their first trimester will receive an oral course of quinine+clindamycin (7 days).
~Individuals with known drug allergy to piperaquine will be treated with AL (+/- sld PMQ as per their pregnancy/breastfeeding status)
~Specific/complex cases will be assessed by a medic and referred to a health facility for treatment if necessary."
15843667|NCT04093752|Drug|Tirzepatide|Administered SC
15843668|NCT04093752|Drug|Insulin Glargine|Administered SC
15843669|NCT04093739|Device|G7 Freedom Constrained Liners|Patients that have been implanted with the G7 Freedom Constrained Liners to repair hip malfunction and/or disease.
15843670|NCT04093726|Other|lollipop|chewing lollipop for 20min
15843671|NCT04093713|Procedure|A novel technique to block the inferior alveolar nerve block using Mepivecaine with Levonordefrin|blocking the inferior alveolar nerve using extroral landmarks
15843672|NCT04093700|Device|SureLock All-Suture Anchor|Subjects that have been implanted with the SureLock All-Suture Anchor to repair the glenoid labrum
15843673|NCT04093687|Other|Endoscopist's training|"The training session will be divided into two parts: theoretical and practical. Trainees will be blinded to the criterion of being chosen due to their performance status.
~During the first, theoretical part, the body of research on the phenomenon of colonoscopy pain will be presented. Aspects on how to deliver a painless colonoscopy (patient characteristics, insertion technique, endoscope characteristics, non-technical skills, additional manoeuvres) will be discussed. This part will be based on the findings from Phase I.
~The second, practical part of the training, will consist of a one-day session of 7 colonoscopies. Participants will be matched with each other. Each participant, will perform one colonoscopy with an oversight of a matched partner, then in turn oversee the colonoscopy of another participant. The rest of the participants will observe a live transmission of each colonoscopy in a separate room, with a commentary from study coordinator."
15843674|NCT04093674|Procedure|de-epithelized (DE) SCTG|subepithelial connective tissue grafts
15843675|NCT04093648|Genetic|TEGAR T cells|"Five different dosing schedules will be evaluated. Three to six patients will be evaluated on each dosing schedule. The following dose levels will be evaluated:DL1: 1x10^7/m2 DL2: 3x10^7/m2 DL3: 1x10^8/m2 DL4: 3x10^8/m2 DL5: 1x10^9/m2 If DLTs are observed on DL1, patients will be enrolled on DL0 at 3x10^6/m2 dose.
~The first patient on each dose level has to be 28 days post-CAR T cell infusion before the second patient can be enrolled. The doses are calculated according to the actual number of GPC3-CAR transduced T cells."
15843676|NCT04093648|Drug|Cytoxan|Cyclophosphamide will be given at a dose of 500 mg/m2/day for 3 days given intravenously
15843677|NCT04093648|Drug|Fludarabine|Fludarabine will be given at a dose of 30 mg/m2/day for 3 days given intravenously
15843678|NCT04093635|Device|Negative Pressure Wound Therapy|VAC was applied by placing sterile pads in two layers with a 16Fr Ryle's tube placed between the two layers and then the wound was sealed by a sterile transparent polyurethane sheet. The tube was connected to a wall-mounted suction device and the pressure will be set at -125 mmHg Mode of NPWT. This dressing will be changed every 72 hrs
15843679|NCT04093622|Genetic|Genetically engineered NK cells|No study drug is administered in this study. Subjects who received lentivirus-mediated genetically engineered NK Cells in a previous trial will be evaluated in this trial for long-term safety and efficacy.
15843680|NCT04093609|Genetic|XIST gene deletion|detection of XIST gene deletion by fluorescence in situ hybridization
15843681|NCT04093596|Genetic|ALLO-715|ALLO-715 is an allogeneic CAR T cell therapy targeting BCMA
15843682|NCT04093596|Biological|ALLO-647|ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
15843683|NCT04093596|Drug|Fludarabine|Chemotherapy for lymphodepletion
15843684|NCT04093596|Drug|Cyclophosphamide|Chemotherapy for lymphodepletion
15843685|NCT04093596|Drug|Nirogacestat|a small molecule, selective, reversible, noncompetitive inhibitor of γsecretase (GSI) that increases BCMA target density on the surface of multiple myeloma cells.
15843686|NCT04093583|Procedure|Exodontia|Atraumatic exodontia followed by simple suture
15843687|NCT04093583|Drug|Alveolar ridge preservation with a PRP (PRGF-Endoret)|Filling of the alveolus with PRGF clot and fibrin plug.
15843688|NCT04093583|Device|Preparation of PRGF using Endoret technology|Preparation of PRGF using Endoret technology following manufacturer instructions
15843689|NCT04093570|Drug|ASTX727|Form: Tablet Route of Administration: Oral
15843690|NCT04093557|Other|Orton Score|Significant a priori predictors of poor prep included: male gender, COPD, diabetes with end-organ damage, severe neurologic disease, constipation medication use, and tricyclic antidepressant use. Proprietary web-based weighted scoring model allows screening clinician to predict which bowel prep would be best for patient depending on which risk factors patients have.
15843691|NCT04093557|Other|Typical Standard of Care|Clinician usual practice of prescribing bowel preps to patient
15843692|NCT04093544|Device|Deep brain stimulation|Steered stimulation using directional leads
15843693|NCT04093531|Drug|Ustekinumab|Up to 15 subjects will receive an infusion loading dose of 6 mg/kg of ustekinumab at baseline, and 90 mg of ustekinumab subcutaneously at week 4, week 12 and week 20. Subjects will be followed for 24 weeks.
15843694|NCT04093518|Drug|Estradiol|2 transdermal patches to be changed twice a week for the duration of 16 weeks
15843695|NCT04093518|Drug|Placebo|2 transdermal patches to be changed twice a week for the duration of 16 weeks
15843696|NCT04093505|Drug|Gemtuzumab Ozogamicin 147|Induction therapy: Gemtuzumab Ozogamicin 3mg/m² on days 1,4 and 7
15843697|NCT04093505|Drug|Gemtuzumab Ozogamicin 1|Induction therapy: Gemtuzumab Ozogamicin 3mg/m² on day 1
15843698|NCT04093505|Drug|Glasdegib|Consolidation & Maintenance therapy Glasdegib 100mg on days 4 to 27
15843699|NCT04093505|Drug|Placebo Oral Tablet|Consolidation & Maintenance therapy Placebo 100mg on days 4 to 27
15843752|NCT04093154|Device|wearing the virtual headset|watching the application by wearing virtual glasses to the child/adolescent
15843753|NCT04093141|Procedure|IRE|in situ irreversible electroporation
15843754|NCT04093128|Other|herbal tea intervention|herbal tea intervention for 7 weeks
15843702|NCT04093479|Other|blood samples|blood samples will be taken repeatedly
15843703|NCT04093466|Drug|CX1003|Oral dose A 4-day single dose period, followed by a period of daily-dose in continuous 28-day treatment cycle (the 1st cycle) or 21-day treatment cycles (the 2nd cycle and beyond) Dosage range: 25 mg, 50mg, 75mg, 100mg
15843704|NCT04093453|Other|Placebo (Sodium Chloride)|Participant receive Placebo (Sodium Chloride)
15843705|NCT04093453|Other|Exercise|1 hour exercise
15843706|NCT04093453|Dietary Supplement|Sodium Propionate|Participant receive Sodium Propionate
15843707|NCT04093440|Other|lifestyle modification|nutrition counselling, diet and physical exercise monitoring, smoking cessation, and medication optimization
15843708|NCT04093427|Other|softSTOPP|Non-invasive ventilation device setting in prismaVENT 30 device enabling an inverse pressure ramp after therapy end
15843709|NCT04093414|Device|Select Secure pacing lead|A Select Secure pacing lead is placed in the bundle of His or Left bundle branch area based upon randomization
15843710|NCT04093401|Other|individualized risk assessment|Individualized risk assessment of developing a second basal cell carcinoma
15843711|NCT04093388|Diagnostic Test|Self-PAP|A single cohort of 250 patients will be recruited from among those who need a Papanicolaou (Pap) smear for routine cervical cancer screening, to perform a self-administered Pap smear immediately prior to the traditional Pap smear. Blinded assessment of both tests will be then conducted.
15843712|NCT04093388|Diagnostic Test|Traditional Pap smear|A single cohort of 250 patients will be recruited from among those who need a Papanicolaou (Pap) smear for routine cervical cancer screening, to perform a self-administered Pap smear immediately prior to the traditional Pap smear. Blinded assessment of both tests will be then conducted.
15843713|NCT04093375|Procedure|Radical Prostatectomy|Radical prostatectomy with or without androgen deprivation therapy
15843714|NCT04093375|Other|Radical Radiotherapy|Radical Radiotherapy with adjuvant androgen deprivation therapy
15843715|NCT04093362|Drug|TAS-120|TAS-120 is an oral FGFR inhibitor
15843716|NCT04093362|Drug|Cisplatin/Gemcitabine|Cisplatin/Gemcitabine is currently 1st line standard of care
15843717|NCT04093349|Genetic|SPK-3006|adeno-associated viral (AAV) vector
15843727|NCT04093310|Device|Word Catheter|Use of the Word catheter to remove the Bartholin's abscess
15843728|NCT04093310|Procedure|Incision-drainage|Incision-drainage to remove the Bartholin's abscess
15843729|NCT04093297|Procedure|Tricuspid Annuloplasty|Patients will undergo repair of tricuspid regurgitation
15843730|NCT04093284|Device|The needle-free jet injector|Continuous insulin therapy for 9 days
15843731|NCT04093271|Dietary Supplement|Rest-ZZZ|A dietary supplement containing melatonin, valerian root, chamomile, passion flower, GABA, hawthorn berry, and lemon balm
15843732|NCT04093271|Drug|Active Comparator - Diphenhydramine HCl|DIN 02229960 encapsulated for blinding purposes
15843733|NCT04093271|Other|Placebo|No active ingredients
15843734|NCT04093258|Device|Dailies Total 1® Multifocal Contact Lenses|TEST
15843735|NCT04093258|Device|Air Optix® Multifocal Contact Lenses Plus HydraGlyde®|CONTROL
15843736|NCT04093245|Behavioral|GEM nurse|hospital-based geriatric emergency nurse (GEM nurse) specialist to support patients during the post-discharge transition period
15843737|NCT04093245|Behavioral|pre- and post-hospitalization medication list reconciliation|pre- and post-hospitalization medication list reconciliation for elderly
15843738|NCT04093245|Behavioral|systematic discharge summaries|systematic discharge summaries given to patients and/or caregiver, and sent to their family physician
15843739|NCT04093245|Behavioral|medical follow-up appointment|a planned follow-up appointment with their family physician
15843740|NCT04093245|Behavioral|follow-up phone call|a systematic follow-up phone call for discharged patients
15843741|NCT04093245|Other|Wiki-based Knowledge tools|access to wiki-based patient-oriented KT tools
15843742|NCT04093245|Other|Telemonitoring service|access to a community-based telemonitoring service
15843743|NCT04093232|Drug|Hymovis|All subjects will receive 2 ultrasound guided Hymovis injections and the goal of the study is to correlate responsiveness to subjects unique SF biomarker panel results before the first Hymovis injection and identify potential mechanism of action of those OA patients who receive the greatest benefit.
15843744|NCT04093219|Drug|IV acetaminophen|use of IV tylenol for pain
15843745|NCT04093219|Other|Placebo|Volume of the placebo (saline) will match that of IV acetaminophen at 100ml 0.9% NaCl
15843746|NCT04093206|Dietary Supplement|EpiCor and Vitamin C|One daily dose
15843747|NCT04093206|Dietary Supplement|Vitamin C|One daily dose
15843748|NCT04093193|Procedure|Debridement|Debridement or cleaning of the sinuses post-operatively has been described as a regular post-surgery procedure .
15843749|NCT04093180|Procedure|Intensive Neurophysiological Rehabilitation System|Intensive Neurophysiological Rehabilitation System (INRS) is a multicomponent approach that consists of different treatment modalities.
15843750|NCT04093180|Procedure|Activity and care as usual|Control group continues usual activity and care while staying in the waiting list.
15843751|NCT04093167|Drug|Pembrolizumab|200mg IV 2 mg/kg IV 400 mg IV 4 mg/kg IV
15843755|NCT04093115|Drug|CX1106|administration of CX1106 at 740 mg/m2 as a 24-hour continuous infusion for 5 days (120 h, d1-5), 21 days per cycle, no more than 6 cycles
15843756|NCT04093102|Diagnostic Test|biomarkers|bio-markers testing will be made to all suspected OSA patients(CRP, Hba1C,uric acid, ESR, plasma fibrinogen, pentraxin3), and to control cases.
15843757|NCT04093089|Device|Bionode IOP Lowering System|Patients wearing Bionode spectacles and customized contact lens and will receive stimulation at 50 Hz, 100 µs, up to 150 µA for 2 hours.
15843758|NCT04093089|Device|Bionode IOP Lowering System|Control: No stimulation
15843762|NCT04093063|Other|Micro-stellated Icosahedron|A portable, inexpensive microsurgery training model that requires the following materials for completion. a stereoscopic dissecting microscope, two jeweler style forceps, a pair of curved-tip micro scissors , 1 meter of monofilament nylon thread, 0.5 meter of polyimide microtubule material , one 15 cm metal ruler, a scalpel blade (#15), and double-sided tape. For a microsurgically-naive subject, a total of 20 hours are required to complete this model.
15843763|NCT04093050|Drug|Vasostrict Injectable Product|Vasostrict® (vasopressin injection, USP)
15843764|NCT04093037|Diagnostic Test|Time #1: Non Invasive Break-Up Time (NIBUT)|"A LacryDiag examination without dye will be realized. All measurements are made without contact. It's calculates the Non Invasive Break-Up Time (NIBUT), Tear Meniscus (TM) height (in millimeters) and number of Meibomian Gland.
~These are different pictures taken with LacryDiag and analyzed."
15843765|NCT04093037|Diagnostic Test|Time #2: MicroInstillation Break-Up Time (MIBUT) + Oxford score|"The MicroInstillation of fluorescein Break-Up Time (MIBUT) will be calculated by manual MIBUT and LacryDiag MIBUT.
~The Oxford score will be calculated. It's used to clinically determine the severity of dry eyes with minimum score at 0 (none) and maximum score at 5 (very severity)."
15843766|NCT04093037|Diagnostic Test|Time #3: Standard Break-Up Time (SBUT)|The Standard Break-Up Time (SBUT) with fluorescein macroinstillation will be calculated by manual SBUT and LacryDiag SBUT.
15843767|NCT04093037|Diagnostic Test|Time #4: Schirmer test|The Schirmer test will be performed. It consists of applying the end of a small strip of blotting paper behind the lower eyelid and examining the strip after 5 minutes.
15843768|NCT04093037|Diagnostic Test|Satisfaction questionnaire to the patient|A satisfaction questionnaire to the patient will be completed at the end of the participation at the study.
15843769|NCT04093024|Drug|Nintedanib (Ofev®)|Capsule
15843770|NCT04093024|Drug|Placebo|Capsule
15843771|NCT04093011|Procedure|Congenital Heart Disease Surgery|Patients with congenital heart disease will undergo congenital heart disease surgery.
15843772|NCT04092998|Procedure|Thermocautery circumcision|Histopathological changes from thermocautery circumcision
15843773|NCT04092985|Device|iECG recording|iECG tracings will be recorded simultaneously, starting and ending at the same time as the standard 12-lead ECG, using the built-in sensors of a smart watch (Apple Watch Series 4) with the ECG application
15843774|NCT04092972|Other|Atherectomy|Straub Rotarex S atherectomy and drug-coated balloon DCB. Predilation of the lesion with a predefined ballon (180 sec, Passeo-18). Thus, no direct DCB will be conducted. All DCB lengths (40mm to 200 mm) and Diameters (3mm to 7mm) are eligible for the Trial as long as used in the superficial femoral artery (SFA).
15843775|NCT04092972|Other|POBA and DCB|Standard predilation (POBA) and DCB. Predilation of the lesion with a predefined ballon (180 sec, Passeo-18). Thus, no direct DCB will be conducted. All DCB lengths (40mm to 200 mm) and Diameters (3mm to 7mm) are eligible for the Trial as long as used in the superficial femoral artery (SFA).
15843776|NCT04092959|Behavioral|Walking|Subjects in this group perform exercise consisting of walking for 30 - 60 min at 40% - 60% HRR intensity 3-5 d•wk-1 for 3 months . Each training includes 5 min warm-up and 5 min cool-down, and the exercise should start after meals for 1 hour . Heart rate is monitored by sports bracelet . Subjects using β- blockers will not use heart rate to monitor exercise intensity , but RPE scores . And RPE( Borg scale) scores are ranged from 11-13.
15843777|NCT04092959|Behavioral|Chinese square dancing group|Chinese square dances have been selected from 24 sets of square dances jointly launched in 2015 and 2017. According to the age and physical health status of the subjects, six dance pieces of are selected as the repertoires of the intervention in this study. Subjects in this group perform exercise consisting of Chinese square dances for 30-60 min at 40% - 60% HRR intensity 3-5 d•wk-1 for 3 months. Each training includes 5 min warm-up and 5 min cool-down , and the exercise should start after meals for 1 hour. Make the subjects step for 30 s to 1 min between each track to adjust the heart rate. Heart rate is monitored by sports bracelet. Subjects using β-blockers will not use heart rate to monitor exercise intensity, but RPE scores. And RPE( Borg scale) scores are ranged from 11-13.
15843778|NCT04092959|Behavioral|Control group|Walking group , Chinese square dancing group and control group are given the same health education brochures or health education lectures once a month . Specific contents of the brochure or lecture include : type 2 diabetes , hypertension related medical knowledge and the significance of intervention treatment ; prevention of type 2 diabetes , hypertension nutrition and exercise recommendations ; basic knowledge of scientific exercise and its matters needing attention .
15843779|NCT04092946|Device|Digital intervention|"Individuals included will be offered a program based on three pillars: education, cognitive-behavioural therapy (CBT) and therapeutic exercise.
~The therapeutic exercise component will be delivered in the form of exercise sessions to be performed independently by the individual at home using SWORD Phoenix. These programs will have a duration of between 8 and 12 weeks, according to the condition, following pre-defined protocols. These protocols can be adapted to the needs, performance and progress of each individual by their assigned physical therapist. Individuals will be asked to perform at least 3 exercise sessions per week, in different days, but will not be excluded in case of lower adherence.
~In addition to the exercises, the individuals will also have access to educational articles written by the clinical team, as well as to a CBT program delivered through a combination of written articles and pre-recorded audio sessions."
15843841|NCT04092413|Device|Dermoscope|It is a non invasive tool that permits the visualization of morphological features that are not visible to the naked eye thus representing a link between macroscopic dermatopathology .
15843780|NCT04092920|Device|laser and SLA|"ligible patients will be randomized to 2 groups control group will receive SLA surface treated implant to replace badly broken tooth immediately after extraction and a study group will receive laser surface treated implant to replace badly broken tooth immediately after extraction.
~atraumatic extraction will be performed and socket will be examined for presence of bone dehesince or fenestration if no, implant will be placed immediately and a implant primary stability will be measured using an ISQ unit and recorded as base Line reading .
~gingival former will be attached to the implant and removed at 2 ,4,8,12 week intervals to record ISQ readings."
15843781|NCT04092907|Drug|HBM9036 0.25% Ophthalmic Solution|Ophthalmic Solution
15843782|NCT04092907|Drug|placebo|Ophthalmic Solution
15843783|NCT04092894|Drug|Suvorexant 20 mg|Administration of oral Suvorexant 20 mg
15843784|NCT04092894|Drug|Placebo oral tablet|Administration of oral placebo (same non-identifiable form as active comparator)
15843785|NCT04092881|Device|Laser|Application of four laser sessions one month apart using short pulsed mode of 1064 nm Nd-YAG laser (Fotona XP® - Accelera mode) using parameters (fluence 20-40 J/Cm2, pulse duration= 0.25 ms and spot size 3-5 mm) for one side.
15843786|NCT04092881|Device|Laser|Application of four laser sessions one month apart (in the same day after Nd-YAG session) using 10600 nm ablative fractional CO2 laser (Deka SmartXide DOT®) using -parameters (fluence 17-20 J/Cm2, pulse duration 700-1000 µs, spacing 600-700 µm and stacking 1-2) on the other. Sessions are separated by one month interval plus three months for clinical follow up.
15843787|NCT04092868|Other|Blood samples PK/ PD protamine|PK/ PD protamine
15843788|NCT04092842|Device|Silicone prosthesis|Silicone prosthesis
15843789|NCT04092842|Procedure|Usual practice|Usual surgery
15843790|NCT04092829|Procedure|FROZEN EMBRYO TRANSFER IN SUBSTITUTED CYCLE|The intervention group will be prepared with hormone replacement therapy with estrogens according to usual clinical practice. Frozen embryos will be transferred after ten doses of exogenous progesterone.
15843791|NCT04092816|Behavioral|FAMILY Intervention|The FAMILY intervention involves 2-3 study visits with a specially-trained intervention facilitator. Study visits are manualized and complemented by patient education materials.
15843792|NCT04092803|Other|Virtual Reality|The system includes a VR headset with VR software already loaded in to it.
15843793|NCT04092790|Device|Virtual Gate Device (VGD)|A VGD will be applied to one randomly-assigned lower limb. The VGD will be operated constantly (apart from times that the patient is being bathed or undergoing investigations or procedures) providing intermittent stimulations for a maximum of 10 days.
15843794|NCT04092777|Behavioral|Strong Minds|The proposed intervention integrates cognitive behavioral therapy techniques combined with mindfulness exercises and promotion of behavioral activation through pleasant activities and developing supportive relationships. The intervention is led by CHWs and organized into 10 sessions, tailored to the participant using a collaborative approach, to improve mood symptoms, augment self-reported functioning, and increase self-reported quality of care among participants with moderate to severe symptoms of depression and/or anxiety. It is complemented by a care manager that links participant to services for needs related to social determinants of health (i.e. education, housing). The intervention has been tailored for delivery by CHWs in Spanish, Mandarin, Cantonese, and English.
15843795|NCT04092777|Other|Enhanced Usual Care|Participants in this arm will receive a booklet about anxiety and depression in Spanish, English, or Mandarin/Cantonese. The Care Manager will call the participant 4 times over the course of 6 months to administer the PROMIS depression (8 item) and anxiety (7 item) short forms, a suicide questionnaire, and a question about medication side effects to mimic the administration schedule in the intervention group. With patient's permission, the care manager will inform the PCP about screening and other assessments and determine if participants should be referred to mental health or substance services and removed from control group given symptom severity.
15843796|NCT04092764|Device|Electroacupuncture|Participants will receive electroacupuncture for 30 minutes once per week for a total of 3 weeks. The acupoints will be stimulated by the electroacupuncture machine with alternating frequencies in order to induce endorphins at different points in the nervous system. Frequencies between 2 Hz and 100 Hz will be utilized. Sterile single-use needles will be placed at Ba Feng, four points on the dorsum of each foot between the digits. KI2 (Rang Gu), a point located at the soles of the feet and SP-4 (Gongsun) will also be needled per recommendation of our acupuncturist. A total of 12 needles will be used per participant.
15843797|NCT04092764|Device|NeuroMetrix|The NeuroMetrix is a point-of-care conduction device that will be used to measure peripheral neuropathy
15843798|NCT04092764|Device|Rydel-Seiffer tuning fork|The level of periphal neuropathy will be measured by vibration detection using a Rydel-Seiffer graduated tuning fork placed on the dorsum of the right great toe between the nail and the distal interphalangeal joint. The two arms of the 128 Hz tuning fork are fitted with calibrated weights at the ends, and as the amplitude decreases, the intersection of the triangles moves upward on the weight. This test will be performed three times and a mean of the scores calculated. Vibration sensation is lost sooner in CIPN, which means that lower scores are associated with increased CIPN
15843799|NCT04092751|Drug|PRA|Single oral 20-mg dose of PRA on Day 1 AM
15843800|NCT04092751|Drug|SCY-078 plus PRA|Twice daily (BID), every 12 hours (Q12H) oral doses of SCY-078 750 mg on Day 1 and Day 2; and on Day 3 a single AM dose of oral SCY 078 750 mg followed by a single 20-mg dose of PRA administered one hour later
15843801|NCT04092738|Behavioral|Walk@WorkApp-Diab|The intervention (Walk@WorkApp-Diab), based on an mHealth program, consists on replacing sedentary job tasks for active ones, during 13 weeks. The intervention group will download the mHealth program into their personal cellphones
15843802|NCT04092725|Drug|DAB|Single oral 150-mg dose of DAB on Day 1 AM.
15843803|NCT04092725|Drug|SCY-078 plus DAB|Twice daily (BID), every 12 hours (Q12H) oral doses of SCY-078 750 mg on Day 1 and Day 2; and single oral AM doses of SCY-078 750 mg on Day 3 and Day 4. On Day 3 a single 150-mg dose of DAB will be administered one hour after the AM dose of SCY-078.
15843804|NCT04092712|Drug|[14C]-CTP-543|Single dose of radiolabeled CTP-543 (approximately 75 μCi) administered as an oral solution
15843805|NCT04092699|Device|semiautomatic software|semiautomatic segmentation is as accurate as the direct volume of maxillary sinus and as well as the manual segmentation.
15843809|NCT04092673|Drug|eFT226|eFT226 is a novel small-molecule, investigational drug being developed by eFFECTOR Therapeutics as an anticancer therapy. eFT226 is a potent and selective inhibitor of eIF4A1-mediated translation and selectively regulates the translation of a subset of mRNAs based on sequence specific recognition motifs in their 5'-UTR. eIF4A1 inhibition by eFT226 downregulates expression of receptor tyrosine kinases and KRAS, leading to decreased signaling through the PI3K/AKT and MAPK pathways. Preclinical efficacy testing of eFT226 demonstrates activity across models of solid tumor cancers with amplifications in HER2, FGFR1/2 and mutations in KRAS (including breast, NSCLC and CRC).
15843810|NCT04092660|Behavioral|Behaviour change Intervention Based on Health Action Process Approach Model|"The Behaviour change intervention based on the Health Action Process Approach model entails delivering interventions in a staged manner. Following are the intervention that will be delivered along with the time point of the delivery.
~Health Pamphlet at the initial screening
~Sleep Apnoea video highlighting the negative consequences at the day of the fitting of the appliance
~Counseling involving motivational interviewing for both the participant and the participant's partner at the day of fitting of the appliance and follow up visits.
~Booster phone calls in between the follow-up visits"
15843811|NCT04092660|Device|Mandibular Advancement Appliance (MAA) or Anti-snoring mouth guard|"Patients with mild-to-moderate sleep apnoea are treated with Mandibular Advancement Appliances [MAA] also known as Anti-snoring mouth guards or Oral appliances. These are best made to fit and use the teeth to hold them in place during sleep. They work by moving (in a gradual fashion) the bottom jaw forward, opening the airway at the back of the throat.
~Both the arms- Intervention arm and Standardized arm will be given the anti-snoring mouth guard. The usage of the device will be measured subjectively by providing a sleep diary to the participants to record the hour of the usage and objectively by downloading the data from a micro sensor chip embedded in the device."
15843812|NCT04092647|Drug|Ashwagandha|Ashwagandha 500 mg po BID
15843813|NCT04092647|Drug|Placebo|Placebo 500 mg po BID
15843814|NCT04092634|Device|Dual mobility implant|Patients that are eligible and consent to the study will be randomized to receive either a dual mobility implant or a traditional single-bearing hip implant. This group is for the dual mobility implant
15843815|NCT04092634|Device|Traditional, Single-bearing hip implant|Patients that are eligible and consent to the study will be randomized to receive either a dual mobility implant or a traditional single-bearing hip implant. This group is for the dual mobility implant
15843816|NCT04092621|Drug|Amiodarone in Parenteral Dosage Form|Amiodarone IV
15843817|NCT04092621|Drug|Amiodarone Pill|Amiodarone tablet
15843818|NCT04092621|Procedure|Direct Current Cardioversion (DCC)|Convert arrhythmia back to sinus rhythm
15843819|NCT04092621|Drug|Rate-control therapy|one or combination of the following: Amiodarone, beta blockers or non-dihydropyridine calcium channel blockers, digoxin
15843820|NCT04092608|Procedure|GDFT|The titration of fluid will be based on stroke volume variation. The goal is to maintain this variable < 13% during surgery with multiple mini fluid challenge of 100 ml of balanced crystalloid.
15843821|NCT04092608|Procedure|LOW CVP (restrictive group)|Goal = CVP < 7mmHg and only 2 ml/kg/h max during surgery.
15843822|NCT04092595|Drug|PF-06651600|PF-06651600: 200 mg dose provided as four 50 mg oral tablets
15843823|NCT04092595|Drug|Rosuvastatin|10 mg oral tablet
15843824|NCT04092582|Drug|MTPS9579A|MTPS9579A IV infusion will be administered at the randomization visit (Week 2), Week 6, and every 4 weeks through Week 46.
15843825|NCT04092582|Drug|Placebo|Placebo matching MTPS9579A will be administered at the randomization visit (Week 2), Week 6, and every 4 weeks thereafter through Week 46.
15843826|NCT04092569|Behavioral|Pre-medical consultation structured diabetes self-care education programme|"The findings of integrative review revealed positive effects of DSME in improving glycemic control and promoting self-care among people with type 2 diabetes.
~An evidence-based protocol is developed based on these findings to generate a DSME program for newly referred patients to SOPCs and before their first medical consultation to improve glycemic control and enhance self-care of people with type 2 diabetes in Hong Kong. The investigator will ensure that this study is conducted in compliance with ICH-GCP and in compliance with the Declaration of Helsinki."
15843827|NCT04092556|Device|transcranial direct current stimulation|tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability.
15843828|NCT04092530|Behavioral|LINCC intervention - enable co-schedule feature|Clinics will offer postpartum contraception appointments earlier and the opportunity to co-schedule these appointments with their infant's next well-baby visit
15843829|NCT04092517|Other|Control Corn Soya Diet|Ingredients (% by weight): Maize (78.30); Whole soya beans (20.00); Vitamin/Mineral FBF-V-13 (0.20); Dicalcium Phosphate anhydrous (1.23); Potassium chloride (0.27)
15843830|NCT04092517|Other|Test Corn Moringa Diet|Ingredients (% by weight): Maize (78.30); Moringa (20.0)
15843832|NCT04092491|Other|blood sample|"1 blood sample during a consultation carried out as part of a medical follow-up:
~2 PAXgene RNA tubes of 2 ml each
~1 dry tube for creatinine and IgA assay
~1 tube of NFs (5ml)"
15843833|NCT04092478|Other|Spinal Anesthesia Position|The patient positions during the spinal anesthesia
15843834|NCT04092465|Procedure|Pulmonary parenchyma resection, lobectomy, pneumonectomy, sleeve lobectomy, extended lobectomy/pneumonectomy|Resection of the downstaged locally advanced NSCLC through formal thoracotomy
15843835|NCT04092452|Drug|PF-06650833|400 mg QD
15843836|NCT04092452|Drug|PF-06700841|45 mg QD
15843837|NCT04092452|Drug|PF-06826647|400 mg QD
15843838|NCT04092452|Drug|Placebo|placebo
15843839|NCT04092439|Dietary Supplement|Watermelon Juice|100% Watermelon Juice
15843840|NCT04092426|Other|opthalmologic examination|opthalmologic examination : Refraction Best corrected visual acuity Intraocular pressure Slit lamp examination
15843842|NCT04092400|Device|Micro-invasive Glaucoma Surgical Devices|Safety and efficacy of Micro-invasive Glaucoma Surgical Devices
15843843|NCT04092387|Other|Cigarettes with varying nicotine content|1) Altering the nicotine content of the tobacco research cigarettes
15843844|NCT04092387|Other|E-Cigarettes|1) Altering the availability of e-cigarettes; 2) Altering option to personalize the e-liquid in the e-cig conditions
15843845|NCT04092374|Procedure|Locking compression plates|Fixation of sternal fracture using locking compression mechanism
15843846|NCT04092361|Device|optical coherence tomography|It generates cross sectional images by analyzing the time delay and magnitude change of low coherence light as it is backscattered by ocular tissues. An infrared scanning beam is split into a sample arm and a reference arm. As the sample beam returns to the instrument it is correlated with the reference arm in order to determine distance and signal change via photodetector measurement. The resulting change in signal amplitude allows tissue differentiation by analysis of the reflective properties, which are matched to a false color scale. As the scanning beam moves across tissue, the sequential longitudinal signals, or A-scans, can be reassembled into a transverse scan yielding cross-sectional images, or B-scans, of the subject. The scans can then be analyzed in a variety of ways providing both empirical measurements (e.g. RNFL or retinal thickness/volume) and qualitative morphological information.
15843847|NCT04092348|Other|complete blood count|"total RNA is isolated from fresh blood samples
~RNA is converted into complementary DNA c.DNA
~cDNA is then analysed by quantitatine Real Time PCR(qRT-PCR) to evaluate the relative expression levels of FoxO3a, PU.1 genes and TATA-binding protein (TBP) ,as an endogenous control gene."
15843848|NCT04092322|Device|Actical accelerometers (Philips Respironics)|patients with stroke will be evaluated by using PASE scale and accelerometer results (accelerometer will be held from Monday to Friday
15843849|NCT04092322|Other|PASE|Physical Activity Scale for Elderly
15843850|NCT04092309|Drug|ACE inhibitor, Sacubitril-Valsartan|Search for Protective effect after chemotherapy and bone marrow transplantation
15843851|NCT04092296|Other|resin infiltration|using infiltrant resin intervene proximal caries
15843852|NCT04092296|Other|remineralization|using fluoride to remineralize proximal caries
15843853|NCT04092296|Other|sham|replace resin with water
15843862|NCT04092257|Procedure|VIA and thermocoagulation|Participants will self-collect a vaginal brush for hr-HPV testing. HPV-positive women and every 10th consecutive HPV-negative woman will complete same-day VIA with colposcopically-directed cervical biopsy and ECC (if lesion seen), and thermocoagulation if ablation-eligible by colposcopy. If no lesion is seen on colposcopy, the woman will have a cervical pap smear and ECC collected, and no thermocoagulation will be performed. Finally, women who are suspicious for cancer at VIA will undergo colposcopically-directed cervical biopsies.
15843863|NCT04092244|Diagnostic Test|CTHRC1 biomarker|its a biomarker detected in the serum of the patients
15843864|NCT04092231|Behavioral|Early speech perception test|The early speech test is one of the closed-set response speech discrimination tests,using object identification technique.It was carefully designed for estimation of speech perception abilities in very young children who have extremely low verbal abilities
15843865|NCT04092218|Other|Questionnaire|"Data will be obtained through a written questionnaire to determine the type of parenting style of parents or caregivers.
~The collected data will be saved and tabulated on computer and finally statistically analysed."
15843866|NCT04092205|Drug|Emeramide|Lipophilic, membrane passing Metal chelator and anti oxidant
15843868|NCT04092179|Drug|Enasidenib|Enasidenib is a drug that blocks a protein called isocitrate dehydrogenase (IDH) 2 from working. The family of IDH proteins have been indicated in the development of leukemia. By blocking IDH2, enasidenib may help stop cancer cells from growing. It is believed that the drug may be more useful in patients with a change (mutation) in their IDH 2 protein. The IDH2 gene (substances in the body that contain instructions for the proper development and function of cells) makes IDH2 proteins. As such, only patients with IDH 2 mutated gene are eligible for this study. Enasidenib is currently approved for the treatment of IDH2 mutated AML.
15843869|NCT04092179|Drug|Venetoclax|Venetoclax is a drug that blocks a protein called B-cell lymphoma (BCL2) protein from working. BCL2 is a protein that helps control whether a cell lives or dies and is thought to help cancer cells to live. Blocking BCL2 is believed to help kill cancer cells. Venetoclax is currently approved for the treatment of type of blood cancer called chronic lymphocytic leukemia (CLL) who have received prior treatment.
15843870|NCT04092166|Other|Stationary Bike|Participants will use a stationary bike machine that also engages the arms and use . This will be performed for 6 minutes, 3 times a week for a total of 8 weeks).
15843871|NCT04092153|Device|Total knee arthroplasy|Surgical implantation of prosthetic knee using robotic-arm assist
15843872|NCT04092140|Device|ultrasound|easy new non invasive tool
15843873|NCT04092127|Other|Video Record|Video Record of the premature infant face before and during the RetCam screening of retinopathy of prematurity
15843960|NCT04091360|Drug|Ensifentrine 100mcg|"Single doses of RPL554 inhaled via pressurised metered dose inhaler:
~Doses are - 100mcg"
15843961|NCT04091360|Drug|Ensifentrine 300mcg|"Single doses of RPL554 inhaled via pressurised metered dose inhaler:
~Doses are - 300mcg"
15843962|NCT04091360|Drug|Ensifentrine 1000mcg|single doses of RPL554 inhaled via pressurised metered dose inhaler: Doses are - 1000mcg
15844550|NCT04086576|Device|DRIVESAFE Evoc|DRIVESAFE Evoc branded smartphone-paired breathalyzer
15843874|NCT04092114|Other|Control|Standard of care (SOC) HIV prevention services in line with the South African DoH (Department of Health) PrEP (Pre-exposure Prophylaxis) rollout program that include daily oral TDF/FTC (tenofovir disoproxil fumarate/emtricitabine). In addition, risk reduction counseling, IPV (Intimate Partner Violence) screening using the VAWS (WHO Violence Against Women Survey) with referrals for counseling, medical care, or shelter assistance, among other care options, if needed and an informational packet regarding HIV prevention services for themselves and male partners will be offered
15843875|NCT04092114|Behavioral|CHARISMA Intervention|"SOC (Standard of Care) per control arm plus provider-administration of HEART and provider-administration of CHARISMA counseling modules, as applicable:
~Module A: General Partner Communication and Relationship Skills
~Module B: Partner Disclosure and Communication around PrEP Use
~Module C: Responding to Intimate Partner Violence and Safety Planning"
15843876|NCT04092101|Other|Cigarettes with varying nicotine content|1) Altering the nicotine content of the tobacco research cigarette
15843877|NCT04092101|Other|E-Cigarettes|1) Altering the availability of e-cigarettes; 2) Altering option to personalize the e-liquid in the e-cig condition
15843878|NCT04092088|Device|tDCS-r|The transcranial stimulation will be applied by a constant current device (tdcs) with an intensity of 2 mA for 20 minutes (the set will be turned on for 20 minutes).
15843879|NCT04092088|Device|TENS-r|Conventional TENS will be applied for 20 minutes. The cathode will be placed on the carpal ligament, and the anode electrodes on the palmar area of the hand, with a layer of conductive gel applied to the area (the set will be turned on for 20 minutes)..
15843880|NCT04092088|Device|tDCS-s|The transcranial stimulation will be applied by a constant current device (tdcs) with an intensity of 2 mA for 20 minutes (the set will be turned off after 30 seconds).
15843881|NCT04092088|Device|TENS-s|Conventional TENS will be applied for 20 minutes. The cathode will be placed on the carpal ligament, and the anode electrodes on the palmar area of the hand, with a layer of conductive gel applied to the area (the set will be turned off after 30 seconds).
15843882|NCT04092075|Device|RF-utilizing powered toothbrush|RF-utilizing Powered toothbrush
15843883|NCT04092075|Device|Control placebo with no RF|Placebo control, toothbrush with no RF
15843884|NCT04092062|Device|ToothWave|RF-utilizing powered toothbrush for teeth whitening
15843885|NCT04092062|Device|powered toothbrush|regular powered toothbrush with no RF
15843886|NCT04092049|Other|lollipop|chewing lollipop for 10 minutes
15843887|NCT04092036|Device|Optic Nerve Sheath Diameter (ONSD) measurement by ultrasound|"ONSD measurements will be performed in the supine patient. Ultrasound gel will be applied over the closed upper eyelid. The ultrasound probe will be placed on the temporal area of the eyelid. Then the probe will be angled in order to display the entry of the optic nerve into the globe.
~ONSD will be measured 3 mm behind the globe in the transverse plane perpendicular to the optic nerve. For each optic nerve three measurements will be made. The ONSD corresponds to the mean of the six values which will be obtained from each patient (three measurements for each eye)."
15843888|NCT04092023|Other|nursing education|Participants will be recruited to attend 2 group sessions; each group will have 10-12 participants and each session will be lasted for 120 minutes. Two subsequent phones follow up to participants will be arranged.
15843889|NCT04092010|Behavioral|Problem-solving education (PSE)|PSE will be offered to mothers with low baseline depressive symptoms (the first, preventive step of the SCI). PSE participants will have their symptoms assessed at each session and will convert to Engagement Sessions if they meet pre-specified 'step up' criteria.
15843890|NCT04092010|Behavioral|Engagement sessions|Engagement sessions will be offered to mothers with greater depressive symptoms to link them to formal mental health services (the second, referral step of the SCI)
15843891|NCT04092010|Behavioral|Usual care|Normal services provided children and their mothers in Head Start
15843892|NCT04091997|Diagnostic Test|serum Eliza assay|laparoscopy and biopsy of lesions in endometriotic patients and seum ELIZA assay of microphage migration inhibitory factor
15843893|NCT04091984|Diagnostic Test|Prospera|No Interventions, this is an observational study.
15843894|NCT04091971|Drug|Ketamine|See arm description.
15843895|NCT04091958|Procedure|Pectoralis myo-glandular flap reconstruction.|Tumorectomy with surgical margin will be evaluated with frozen-section examination. Reconstruction starts with mobilization of skin flaps. The sternal head of the pectoralis major muscle will be disconnected from its insertion at the humerus. The muscle fibers will be mobilized off the chest wall. The pectoralis major receives dual blood supply. The pectoral branches of the thoraco-acromial artery enter the superior part of the muscle and the perforator branches of the internal mammary artery enter the medial part of the muscle. According to the location of the defect in the breast, the muscle will be mobilized based on one vascular pedicle. The muscle flap may consist of all or some segmental fibres of the sternal head of the pectoralis major muscle. In all cases, the muscle flap connection to the overlying breast parenchyma is kept intact and the clavicular head of the pectoralis major muscle is undisturbed. Closure of the cavity in layers over suction drain will follow.
15843896|NCT04091945|Drug|LT3001 Drug Product|Active comparator
15843897|NCT04091945|Drug|Placebo|Placebo comparator
15843898|NCT04091932|Drug|Pembrolizumab|Monthly usage of Pembrolizumab (2mg/kg weight) for 3 months.
15843899|NCT04091919|Diagnostic Test|2D- Transthoracic Echocardiography (TTE)|2D- Transthoracic Echocardiography (TTE) derived Tissue Doppler and Strain imaging
15843900|NCT04091906|Device|Peripheral blood mononuclear cell apheresis|Peripheral blood mononuclear cell donation for tumor immunotherapy study of UCAR-T cells
15843901|NCT04091893|Behavioral|Usual care/wait list|Individuals in this group can continue with their usual care (but receive no museum-based intervention)
15843902|NCT04091893|Behavioral|Art Rx|Individuals in this group participate in a specialized tour of an art museum
15843903|NCT04091893|Behavioral|Artful Meditation|Individuals in this group participate in a meditation and art appreciation program at an art museum
15843904|NCT04091880|Biological|EV71 vaccine and influenza vaccine|simultaneously administrated with EV71 vaccine and influenza vaccine
15843905|NCT04091880|Biological|EV71 vaccine|administrated with EV71 vaccine only
15843906|NCT04091880|Biological|influenza vaccine|administrated with influenza vaccine only
15843963|NCT04091360|Drug|Ensifentrine 3000mcg|"Single doses of RPL554 inhaled via pressurised metered dose inhaler:
~Doses are - 3000mcg"
15843907|NCT04091867|Drug|sEphB4-HSA with chemotherapy|sEphB4-HSA is a fusion protein combining the soluble extracellular EphB4 domain with albumin that targets the ephrin B2 receptor, which is thought to mediate resistance to EGFR-targeted therapy, and acts as a radiosensitizer by enhancing DNA damage and promoting apoptosis. Concurrent chemotherapy drug (either cisplatin or carboplatin): Per treating physician discretion, and treatment plan is based per NCCN guidelines. These can be administered in tri-weekly or weekly doses during the radiation period. The participant will receive the first infusion on Day 15 (+/- 3 days).
15843908|NCT04091867|Drug|Cetuximab|Loading dose 400 mg/m2 on D9 Concurrent dose 250mg/m2 weekly D15± 3 day window
15843909|NCT04091867|Radiation|Radiation Therapy|6930 cGy IMRT starting D15-D18
15843910|NCT04091854|Drug|HMS5552|To observe the progress of diabetes mellitus after 52 or 28 weeks of HMS5552 treatment for type 2 diabetes mellitus
15843911|NCT04091841|Drug|protein supplement|Three sachet of protein supplement to be mixed in with water used daily.
15843912|NCT04091841|Other|Carbo Mass|Three sachet of Carbo Mass supplement to be mixed in with water used daily.
15843913|NCT04091815|Other|Type of anaesthesia|Two different types of anesthesia general vs combined (spinal and general)
15843914|NCT04091802|Procedure|interdental papilla reconstruction with L-PRF|interdental papilla reconstruction with single layer of L-PRF versus multiple layers of L-PRF
15843915|NCT04091789|Drug|Pure Femme Tablets|A sublingual tablet containing 30 mg of cannabidiol (CBD), 1 mg tetrahydrocannabinol (THC), 97 mg palmitoylethanolamide (PEA), and a 0.2 mg combination of myrcene, beta-caryophyllene, humulene, linalool, and limonene and peppermint oil.
15843916|NCT04091776|Radiation|CT scan|"Quantitative CT scan to measure localized osteoporosis and detection of cortices comminution.
~Blinded surgeon decision as regard to replace or to fix using DHS or PFN (depending on x-rays data only).
~Pathological assessment of osteoporosis in retrieved bone in patients whom hip replacement was decided.
~Assessment of fixation failure in fixed fractures if occurred.
~Fixation failure is defined as:
~5.1. Lag cut through 5.2. Lag cutout 5.3. Z-effect (lag penetration) 5.4. Non-union (within 6 months) 5.5. Loss of reduction with progressive varus deformity 5.6. Femoral fracture 5.7. Intra-operative fracture of lateral wall or anterior cortex"
15843917|NCT04091763|Drug|Polidocanol Injectable Foam|"Two distinct periods were considered: intervention and follow-up. During the intervention period patients were observed at 3-week intervals (minimum of 3 weeks and maximum of 9 weeks depending on the number of instrumental treatments performed). The required number of sessions of any of the office-based treatments (maximum of 3 sessions) was determined by clinical and anoscopy response (if after the treatment the participant scored zero points in the Sodergren scale or the anoscopy did not reveal significant hemorrhoidal disease, there was no place for additional instrumental therapy and the patient started the follow-up period.
~If there was therapeutic failure at the end of the third session or if there was a significant complication (moderate or severe) the patient's participation in the study ended and he was referred for treatment with other type of office-based procedure or surgery."
15843918|NCT04091763|Device|Rubber band ligation|"Two distinct periods were considered: intervention and follow-up. During the intervention period patients were observed at 3-week intervals (minimum of 3 weeks and maximum of 9 weeks depending on the number of instrumental treatments performed). The required number of sessions of any of the office-based treatments (maximum of 3 sessions) was determined by clinical and anoscopy response (if after the treatment the participant scored zero points in the Sodergren scale or the anoscopy did not reveal significant hemorrhoidal disease, there was no place for additional instrumental therapy and the patient started the follow-up period.
~If there was therapeutic failure at the end of the third session or if there was a significant complication (moderate or severe) the patient's participation in the study ended and he was referred for treatment with other type of office-based procedure or surgery."
15843919|NCT04091750|Drug|Nivolumab|"Induction: 3mg/kg IV every 3 weeks x 4 cycles
~Maintenance: 480mg IV every 4 weeks for up to 92 weeks"
15843920|NCT04091750|Drug|Ipilimumab|Induction: 1mg/kg IV every 3 weeks x 4 cycles
15843921|NCT04091750|Drug|Cabozantinib|Induction and Maintenance: 40mg PO daily
15843922|NCT04091737|Biological|Autologous enriched CD34+ cell fraction that contains CD34+ cells transduced with lentiviral vector encoding human γ-globinG16D and short-hairpin RNA734|"Cryopreserved formulated autologous enriched CD34+ cell fraction that contains CD34+ cells transduced with lentiviral vector encoding human γ-globinG16D and short-hairpin RNA734 in a bag for infusion
~Plerixafor to mobilize hematopoietic stem cells prior to each apheresis
~Single dose melphalan before administration of CSL200"
15843923|NCT04091711|Device|ReX-C system|Oral oncolytic medications are dispensed to patients via ReX-C system
15843924|NCT04091698|Drug|Co-Enzyme Q10 mucoadhesive tablets|will receive topical co enzyme q10 in the form of mucoadhesive tablets 3 times daily for 3months.
15843925|NCT04091685|Device|Gamma camera imaging|Use gamma camera in detection of renal cortical defects
15843926|NCT04091672|Device|Autografting with RECELL overspray|Autografting more widely meshed than the pre-specified grafting plan with RECELL overspray, along with Telfa™ Clear and Xeroform™ wound dressings
15843927|NCT04091672|Procedure|Conventional Autografting|Autografting according to the pre-specified grafting plan, along with Telfa™ Clear and Xeroform™ wound dressings
15843928|NCT04091659|Other|Virtual Reality Education|Virtual Reality Education (Intervention): The experimental group of libraries will receive the virtual reality simulation, which is guided by the NLN Jeffries Simulation Theory, and lasts 9 minutes. The virtual reality education is based on scenes and dialogue conducted during the hybrid high-fidelity simulation, from a script developed using the existing hybrid simulation on opioid overdose intervention. This virtual reality education is an educational intervention.
15843929|NCT04091659|Other|Standard Education|Standard Educational (Control): The public health department's training includes printed handouts on how to administer naloxone and youtube videos on how to spot signs and symptoms of overdose and administer naloxone. Additionally, staff are on hand to provide one on one verbal educational trainings to local community members voluntarily seeking education.
15843930|NCT04091646|Drug|ARQ-154 foam 0.3%|experimental
15843931|NCT04091646|Drug|ARQ-154 vehicle foam|experimental
15843964|NCT04091360|Drug|Ensifentrine 6000mcg|"Single doses of RPL554 inhaled via pressurised metered dose inhaler:
~Doses are - 6000mcg"
15843965|NCT04091360|Drug|Placebos|"Single doses of Placebo inhaled via pressurised metered dose inhaler:
~Doses are - Placebo"
15844551|NCT04086576|Device|BACtrack Vio|BACtrack Vio branded smartphone-paired breathalyzer
15843932|NCT04091633|Behavioral|WHO School Mental Health Program|World Health Organization (WHO) School Mental Health Program (SMHP) is a manual based multi-component, multi-tiered and evidence-informed intervention for common mental health problems in school going children. SMHP is designed to be introduced into the normal classroom and school setting by trained teachers. The intervention has a universal component which takes a whole school approach that aims to promote mental health among all school children. It includes basic counseling skills for teachers, core values of mental health promoting schools and other health promoting efforts that impact upon mental health and can be administered to all students in school and classroom settings. The manual also contains targeted intervention strategies on anxiety, separation anxiety/ school refusal, post-trauma, depression, suicide, ADHD, autism, psychosis, conduct problems and substance use problems that can be implemented by teachers in classroom settings.
15843933|NCT04091633|Behavioral|Enhanced School Mental Health Program (eSMHP)|Informed by the results of pilot implementation, a number of content and delivery adaptations have been made to the School Mental Health Program (SMHP) to address the implementation challenges to scale-up of program in Pakistan. The adapted version of the intervention is called Enhanced School Mental Health Program (eSMHP). Enhancements to conventional SMHP have occurred at two levels: A) Content enhancements, such as a collaborative care model for engaging parents/primary caregivers, strategies for teacher's well-being, and adaptation and operationalization of particular clinical intervention strategies and B) Technological enhancements which include adaptation of the training manual for delivery using an online training platform, and a 'Chat-bot' to aid the implementation of intervention strategies in classroom settings.
15843934|NCT04091620|Procedure|Transanal Total Mesorectal Excision|As above
15843935|NCT04091620|Procedure|Robotic Total Mesorectal Excision|As above
15843936|NCT04091607|Other|Music Therapy|Subject will listen to Music using provided ear buds or headphones.
15843937|NCT04091594|Device|Flexible orthotic|Participants will receive the SIAFO to wear
15843938|NCT04091594|Device|Standard orthotic|Participants will received the standard AFO to wear
15843939|NCT04091581|Drug|Systane Complete|Systane Complete will be instilled and rate of evaporation assessed before and after.
15843940|NCT04091555|Dietary Supplement|HLNatural Tension|Understand the impact of the supplement on Tension Headaches
15843941|NCT04091542|Device|Optiflow/Ventilator|Participants will have 2 days with optiflow, 2 days with ventilator.
15843942|NCT04091529|Device|RADIOFREQUENCY ABLATION OF UTERINE MYOMAS|The ablation device consisted of an radiofrequency (RF) energy generator (STARmed, RF generator VRS01) and an electric pump for the continuous cooling of the electrode tip. The RF generator to which the electrode (STARmed Gyeonggi-Do, Korea) is connected displays simultaneously the temperature of the electrode tip, the tissue impedance characteristics, the power and the ablation time. A 35 cm long 18Gauge internally cooled electrode with an exposed tip of 10 mm or a variable exposed tip was used
15843943|NCT04091516|Behavioral|Low-fat plant-based diet|Participants will follow a diet that consists of whole grains, vegetables, legumes, and fruits, with no restriction on energy intake. Animal products and added oils will be excluded. Except for light refreshments and tastings at the group sessions, no meals will be provided. Participants will handle their own food preparation and purchases, with guidance from the education team, with no restriction on energy intake.
15843944|NCT04091503|Drug|Intranasal Modified Temozolomide|"Intranasally Modified Temozolomide is administered to patients at a dose of 75/150/200 mg / M2 for five days continuously. After the 5-day course, patients do not take treatment for two days, and they will be examined on an outpatient basis (blood tests, kidney and liver tests, visually mucous membranes of the mouth, nasal cavity, olfactory rapid tests, including the University of Pennsylvania test, etc.).
~After 30 days after the first intranasal administration of Modified Temozolomide (IM-TMZ), all patients undergo an MRI of the brain with perfusion and ultrasound of the abdominal cavity as an outpatient, after which the results are evaluated"
15843945|NCT04091490|Drug|Nivolumab|Combination of 2 cycles of Nivolumab as a monotherapy with 4 cycles of high-dose chemotherapy (DHAP chemoregimen) with Nivolumab
15843946|NCT04091464|Behavioral|Backward Walking Training|Training will consist of BW training on both a treadmill and overground. All participants will receive 1x/week training with a trained member of the research team, who will progress the participant week-to-week and ensure safety. Treadmill speed will be determined by baseline BW walking speed and incrementally increased with each training week to subject tolerance. Participants will follow a home exercise program for the remainder of the week that includes BW, backward stepping, and functional exercises that incorporate BW movements.
15843947|NCT04091464|Behavioral|Forward Walking Training|Training will consist of FW training on both treadmill and overground. All participants will receive 1x/week training with a trained member of the research team, who will progress the participant week-to-week and ensure safety. Treadmill speed will be determined by baseline FW walking speed and incrementally increased with each training week to subject tolerance. Participants will follow a home exercise program for the remainder of the week that includes FW, forward stepping, and functional exercises that incorporate FW movements.
15843948|NCT04091451|Biological|Herpes Zoster subunit (HZ/su) vaccine (GSK1437173A)|2 doses of the HZ/su vaccine in a 0,2 Months schedule, administered intramuscularly
15843949|NCT04091451|Drug|Placebo|2 doses of the placebo in a 0,2 Months schedule, administered intramuscularly
15843950|NCT04091438|Drug|TAK-925|TAK-925 IV infusion.
15843951|NCT04091438|Drug|TAK-925 Placebo|TAK-925 placebo-matching IV infusion.
15843952|NCT04091425|Drug|TAK-925|TAK-925 IV infusion
15843953|NCT04091425|Drug|Placebo|TAK-925 placebo-matching IV infusion
15843954|NCT04091412|Drug|Butylphthalide Soft Capsules|The first class national new drug for the Treatment of Mild to Moderate Acute Ischemic Stroke; Long-term application can improve collateral circulation.
15843955|NCT04091399|Drug|Stamatological tamponade Contipro|The drug is composed from the Hyaluronic acid and Octenidine dihydrochloride. It is designed to perform comparatively in pain alleviation and to promote healing of the alveolar osteitis while avoiding the side effects.
15843957|NCT04091373|Combination Product|cotadutide multidose pen injection|SC injection in the upper arm
15843958|NCT04091373|Combination Product|cotadutide multidose pen injection|SC injection in the lower abdomen
15843959|NCT04091373|Combination Product|cotadutide multidose pen injection|SC injection in the thigh
15843966|NCT04091347|Behavioral|DAPPER|The DAPPER program is person directed and will consist of 8 nurse visits during which the nurse assesses each participant for pain, depression and frailty and then implements a manualized individually tailored intervention. Participants will be randomized into either the intervention or the wait list control group. Once the intervention group has completed the intervention group's visits, the wait list control group will begin the waitlist control group's visits. All participants will all be offered the same information and format of nurse visits. The nurses will systematically tailor the content of the visits to the participants' risk profile and goals based on protocols. All participants will be assessed at the start of the study, at 12 weeks and 24 weeks.
15843967|NCT04091334|Device|Focused ultrasound of the lungs (FLUS) and focused cardiac ultrasound (FoCUS)|"FLUS: Scanning 8 zones of the front and lateral of the thorax. Record number of B-lines, consolidations, pneumothorax, pleural effusions.
~FoCUS: Scan the heart in different views and record the ejection fraction, size of the right side of the heart, pericardial effusion, tricuspid annular plane systolic excursion (TAPSE), inferior vena cava (IVC) diameter, and IVC collapsibility Index (IVC-CI)."
15843968|NCT04091334|Other|Standard care|Standard care and evaluation and monitoring
15843969|NCT04091308|Other|Usual Care|Usual care involves physiotherapeutic rehabilitation in an unknown format, and will, therefore, be monitored closely and described accordingly.
15843970|NCT04091308|Other|Usual Care with Protein Supplementation|The intake of protein supplementation (ARLA PROTINO) will be consumed by participants in the form of protein-enriched yogurts for easy consumption two times daily, with each bottle containing 14 g of protein.
15843971|NCT04091308|Other|Individualized Physical Exercise Training with Protein Supplementation|Besides getting prescribed individualized physical exercise training programs, this group will consume protein supplementation (ARLA PROTINO) in form of protein enriched yogurts for easy consumption, two times daily, with each bottle containing 14 g of protein.
15843972|NCT04091295|Drug|DeltaRex-G|Intravenous infusions of DeltaRex-G for treatment of advanced pancreatic cancer and sarcoma that have failed standard therapies
15843973|NCT04091282|Other|No intervention|No intervention
15843974|NCT04091269|Device|automatic adjustmen of inspiratory triger and cycling-off based on waveform and PSV with fixed Esence|The ventilators have a compunter drived funcation of automatic adjustmen of inspiratory triger and cycling-off based on waveform, IntelliCycleTM 2.0.
15843975|NCT04091256|Other|Single arm clinical study|Participants will be treated with desensitizing toothpaste containing zinc-carbonate hydroxyapatite nanocrystals (Zn-CHA) for 8 weeks.
15843976|NCT04091243|Drug|Romosozumab|Experimental drug for the treatment of glucocorticoid induced osteoporosis
15843977|NCT04091230|Device|TRUSbx|Trans Rectal UltraSound guided Prostate Biopsy
15843978|NCT04091217|Drug|Atezolizumab|Atezolizumab 1200 mg will be administered intravenously every 3 weeks.
15843979|NCT04091217|Drug|Bevacizumab|Bevacizumab 7.5 mg/kg will be administered intravenously every 3 weeks.
15843980|NCT04091204|Drug|Olaparib tablets|Olaparib is given orally at the dose of 300 mg bid continually as maintenance therapy after a platinum based chemotherapy
15843981|NCT04091191|Dietary Supplement|Meta19.01|A specialized nutraceutical containing plant extracts, vitamins and fish oil
15843982|NCT04091178|Dietary Supplement|VITAMIN D|ORAL SOLUTION (2 ml) at 100.000 UI
15843983|NCT04091165|Other|My Plate Calorie Tracker|"My Plate Calorie Tracker is a user-friendly weight management, calorie record application, available for smart phone devices. Users have the option to input items manually (i.e., calories, carbohydrates, fats, and proteins), select from a list of popular food items, or scan barcodes on the food packaging. In addition to food entries, users can also enter daily water intake and physical activities. Once an account is created, data entered into the mobile application can be sync'd to the My Plate Calorie Tracker website."
15843984|NCT04091152|Other|usability assessment|"Usability of ardoiz will be assesse using a validated usability questionnary"
15843985|NCT04091139|Behavioral|Unified protocol for adolescents (UP-A)|"The Unified Protocol (UP) is an emotion-focused, cognitive-behavioural intervention that is developed to target core temperamental characteristics underlying anxiety and depressive disorders. The goal of the UP is to help patients to cultivate a greater willingness to experience uncomfortable emotions and to reduce maladaptive emotion response tendencies, so as to lessen the intensity and frequency of uncomfortable emotions. Ehrenreich and colleagues modified from the original UP and developed the UP for adolescents (UP-A).
~A Chinese treatment protocol would be developed based on the UP-A. Contents of the treatment includes motivational enhancement, psychoeducation of emotion, avoidance and emotion driven behaviours, interoceptive exposure, cognitive reappraisal, emotion awareness training and emotion exposure. It consists of 10 to 12 individual sessions for the adolescents, and 4 to 6 sessions for parents or guardians."
15843986|NCT04091139|Behavioral|Treatment as usual (TAU)|TAU participants will receive usual clinical psychological service provided in the clinic (i.e. treatment as usual) in the first 12 weeks, before they start receiving same individual treatment program based on UP-A.
15843987|NCT04091126|Drug|Belantamab mafodotin|Selected doses of belantamab mafodotin will be administered as intravenous infusion.
15843988|NCT04091126|Drug|Bortezomib|Bortezomib will be administered subcutaneously or intravenously 1 hour after the belantamab mafodotin infusion.
15843989|NCT04091126|Drug|Lenalidomide|Lenalidomide will be administered as 25 or 10 mg orally, depending upon renal function.
15843990|NCT04091126|Drug|Dexamethasone|Dexamethasone will be administered orally as 20 mg in cycles 1-8 and 40 mg in Cycle 9 onwards.
15843991|NCT04091100|Procedure|Electroacupuncture|An electrical current of 2 mA and 60 Hz was administered using the Enraf Nonius Sonoplus 492 (OPTOMED) device for 20 minutes. All the treatments were performed for 2 sessions per week for 3 weeks. Both groups were given a home program involving neck stretching and posture exercises. The exercises were to be performed at least two times a day in two sets of fifteen repetitions.
15843992|NCT04091100|Procedure|Myofascial Release|longitudinal stretching, friction massage and pinching technique, All the treatments were performed for 2 sessions per week for 3 weeks. Both groups were given a home program involving neck stretching and posture exercises. The exercises were to be performed at least two times a day in two sets of fifteen repetitions.
15843993|NCT04091087|Drug|crisaborole ointment|crisaborole ointment
15843994|NCT04091087|Other|vehicle ointment|vehicle ointment
15843995|NCT04091074|Drug|Ticagrelor|Half of patients undergoing carotid stenting take ticagrelor+aspirin
15843996|NCT04091074|Drug|Clopidogrel|Other half ofpatients undergoing carotid stenting take clopidogrel+aspirin
15843997|NCT04091074|Procedure|Carotid stenting|Patients with carotid stenosis will undergo carotid stenting
15843998|NCT04091061|Drug|PF-06865571 100 mg|PF-06865571 in 100 mg oral tablet will be administered on Day 1
15844000|NCT04091035|Other|To describe the incidence of disease and evaluate risk factors|Se above
15844001|NCT04091022|Drug|Solaraze and Vaniqa|Solaraze-topical diclofenac 3% and Vaniqa-topical eflornithine hydrochloride Cream, 13.9% applied to bilateral arms for one year
15844002|NCT04091009|Drug|Buprenorphine|"Participants will be randomly assigned to be maintained on their daily dose of buprenorphine or to have their buprenorphine reduced to 16mg on the day before surgery.
~Participants in the reduced group will then be prescribed 8mg buprenorphine daily from the day of surgery until transitioned back to their regular dose of buprenorphine when postoperative surgical pain has subsided"
15844003|NCT04091009|Drug|Buprenorphine/naloxone|"Participants will be randomly assigned to be maintained on their daily dose of buprenorphine/naloxone or to have their buprenorphine/naloxone reduced to 16mg on the day before surgery.
~Participants in the reduced group will then be prescribed 8mg buprenorphine daily from the day of surgery until transitioned back to their regular dose of buprenorphine when postoperative surgical pain has subsided"
15844004|NCT04090996|Diagnostic Test|Dual TAsk|"Motor assessment includes:
~posturographic examination in Single-task (ST) and Double-task (DT)
~an analysis of ST and DT walking;
~Timed Up and Go (TUG) performances in real (rTUG) and imagined (iTUG) versions;"
15844005|NCT04090983|Behavioral|Cognitive-behavioral therapy (Hesslinger protocol)|Cognitive-behavioral therapy in a group format focusing on improving symptoms of ADHD, specifically by using skills in counteracting hyperactivity and impulsiveness, and promoting mindful awareness.
15844006|NCT04090983|Behavioral|Cognitive-behavioral therapy (CADDI protocol)|Cognitive-behavioral therapy in a group format focusing on improving inattentive symptoms of ADHD, specifically by using skills in organizing, executing, and completing activity, and promoting mindful awareness.
15844007|NCT04090970|Device|Briagen|Natural complex carbohydrate wound dressing for skin wounds
15844008|NCT04090957|Drug|Estetrol oral tablet|Estetrol oral tablet will be administered orally once daily.
15844009|NCT04090957|Drug|Placebo oral tablet|Placebo oral tablet will be administered orally once daily.
15844010|NCT04090944|Procedure|the fiberoptic laryngoscope (KARL STORZ 11301BN1, Germany) for confirmation of LMA position|-The position of LMA will be assessed by another anesthetist (blinded assessor) using the fiberoptic laryngoscope (KARL STORZ 11301BN1, Germany) per the grading licensed by Aoyama et al.
15844011|NCT04090931|Procedure|Orthodontic treatment|leveling and aligning stage in orthodontics
15844013|NCT04090905|Diagnostic Test|Holter monitoring|Cardiac rhythm monitoring before, during and at least 72 hours after abdominal surgery
15844014|NCT04090892|Procedure|selective percutaneous muscle release|Children will be evaluated before and two times after they undergo a selective percutaneous myofascial release. Investigators make no determination about the need for the surgery or which muscles are released, nor do they participate in the surgery. The investigators are assess outcomes on gait and motor function.
15844015|NCT04090879|Other|Either normal nicotine content cigarettes (15.8mg/g) or reduced nicotine content cigarettes (0.4mg/g)|1) Altering the nicotine content of the tobacco research cigarette
15844016|NCT04090879|Other|E-Cigarettes|1) Altering the availability of e-cigarettes; 2) Altering option to personalize the e-liquid in the e-cig condition
15844017|NCT04090866|Other|PET/MRI|Positron Emission Tomograph/Magnetic Resonance Imaging - participants will undergo PET/MRI prior to initiation of pulmonary vasodilator therapy and again 4-6 months after initiation of therapy
15844018|NCT04090853|Device|Venus Bliss|The investigational device (Venus Bliss™) is a non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1064 nm diode laser applicators (60 mm x 60 mm). A belt is included to allow the operator to secure the laser applicators on the lipolysis treatment area, allowing hands free operation. The device uses vacuum assisted radiofrequency (RF) and PEMF (pulsed electromagnetic field) technology which has been shown in clinical studies to be safe and effective in body circumferential reduction and skin tightening.
15844019|NCT04090840|Behavioral|Intermittent Fasting|Time restricted eating for 8 hours per day, with 16 hour fast. During the daily fast, patients are encouraged to drink water, black coffee, or green tea without sugar, cream, milk, or sweeteners.
15844020|NCT04090827|Other|Nurse-led transition intervention and access to the iHeartChange website|"Elements of the transition interventions include: (i) introduction to transition and its importance, (ii) creation of a MyHealth Passport, (iii) review diagram of participant's cardiac anatomy, (iv) discussion of 3 potential future cardiac complications (v) iHeartChange website (vi) discussion of the concept of self-management (vii) discussion and promotion of communication skills by the adolescent with their healthcare team via the GLADD technique (Give, Listen, Ask, Decide, Do) (viii) a 3-sentence summary about their CHD (ix) ongoing text/email support from RN"
15844021|NCT04090814|Device|HeatTens (HV-F311-E)|(1) 2~108 Hertz (modulation program inside); (2) 100 microseconds (pulse duration)
15844022|NCT04090801|Drug|Topical minoxidil 5% in 90% ethanol and 5% propylene glycol|
15844023|NCT04090801|Drug|Topical minoxidil 5% in pure ethanol alone|The treatment will be continued twice daily.for six months with regular visits at 3 months intervals.
15844024|NCT04090801|Other|Placebo (Ethanol)|The treatment will be continued twice daily.for six months with regular visits at 3 months intervals.
15844025|NCT04090788|Dietary Supplement|dried bitter-gourd supplements|intervention with 2.4g/d dried bitter-gourd supplements
15844026|NCT04090788|Dietary Supplement|dried cucumber supplements|reference intervention with 2.4g/d dried cucumber supplements
15844027|NCT04090775|Drug|Opdivo Injectable Product|"Opdivo (nivolumab): PD-1 inhibitor antibody
~Injectable 10mg/mL, only 1 mL injected."
15844028|NCT04090775|Drug|Yervoy Injectable Product|"Yervoy (ipilimumab): Anti-CTLA-4 antibody
~Injectable 5mg/mL, only 1 mL injected."
15844552|NCT04086576|Device|Drinkmate|Drinkmate branded smartphone-paired breathalyzer
15844029|NCT04090775|Drug|Cytoxan|"Cytoxan (cyclophosphamide): Chemotherapy agent
~Both Injectable and Oral low dose:
~Injectable 250mg/m2, only 1 mL injected. Oral low dose cyclophosphamide: option of either 50mg once daily pill or 25mg twice daily pill for two weeks on, then two weeks off, then two weeks on again."
15844030|NCT04090775|Procedure|Cryosurgical freezing (cryosurgery)|Cryosurgery, also known as cryoablation, for prostate cancer works by freezing the cancer cells inside the prostate gland. Cryoablation will release intact antigens to prime the immune system.
15844031|NCT04090762|Behavioral|Conditional cash transfer|Pregnant women receive cash payments conditioned on their use of prenatal services and use of a health facility for child birth.
15844032|NCT04090762|Behavioral|Risk information provision|Pregnant women who exhibit characteristics associated with a greater risk of a poor birth outcome - these will be identified from the medical and epidemiological literature - will be informed that they possess these characteristics.
15844033|NCT04090749|Behavioral|Caregiver-Support|intervention incorporating 5 individualized, nurse-led, home-based sessions, with telephone check-ins and text reminders, according to participant preference. Caregiver-Support will help caregivers articulate statements of purpose in life, set goals to address fatigue and caregiver burden, provide instrumental support through a benefits check up and promote identification and increased connection with the caregiver's social network.
15844034|NCT04090736|Drug|Pevonedistat|Pevonedistat 20 mg/m2 intravenous on days 1, 3, and 5 (28-day cycles)
15844035|NCT04090736|Drug|Azacitidine|Azacitidine 75 mg/m2 subcutaneous on a 5-on/2-off [weekend]/2-on schedule (28-day cycle). Intravenous for patients who have non-tolerated local reactions
15844036|NCT04090723|Behavioral|CBI-CC with peer navigation|Computer delivered brief alcohol intervention enhanced with information of HIV infection, HIV risk, and comorbid mental health disorders
15844039|NCT04090697|Drug|Oxandrolone|Oxandrolone 2.5mg tabs will be suspended in multi-chain triglyceride (MCT) oil and administered buccally.
15844040|NCT04090684|Drug|Fixed dose combination Ciprofloxacin/Celecoxib|Fixed dose Ciprofloxacin and Celecoxib capsule to be taken twice daily, total dose 748mg/day
15844041|NCT04090671|Diagnostic Test|Multidimensional Dyspnea Profile|The Multidimensional Dyspnea Profile measures the intensity of dyspneic breathing discomforts. It tests five sensory qualities that describe the patient's dyspnea in its respective intensity. Additionally it includes five potential reactions. The MDP is designed to refer to a specific event of time.
15844042|NCT04090658|Biological|RSV_PreF3 Vaccine (GSK3844766A) adjuvanted with AS01B|Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the non-dominant arm preferably.
15844043|NCT04090658|Drug|Placebo|Two doses administered intramuscularly at Days 1 and 61 in the deltoid region of the non-dominant arm preferably.
15844044|NCT04090645|Device|TheraSphere|TheraSphere® is delivered into the liver tumor through a catheter placed into the hepatic artery. The hepatic artery provides the main blood supply to the tumor in the liver, whereas the portal vein supplies blood to normal liver parenchyma. TheraSphere® is embolized within the tumor and exerts a local beta radiation radiotherapeutic effect with a relatively limited concurrent injury to surrounding normal tissue.
15844045|NCT04090632|Diagnostic Test|Closed Kinetic Chain Upper Extremity Stability Test|Each patient receive the same intervention, the CKCUEST. The CKCUEST is a functional test which assess shoulder's stability. Patient is in push-up position, with 91 cm between his hands. His body is straight and his foots are squeeze. patient has to touch his hand with his other one and returns in the initial position. Then, patient repeats this movement with his other hand, etc, during 15 secondes. The CKCUEST score is the movement's number performed.
15844046|NCT04090619|Other|Questionnaire Administration|Complete questionnaires
15844047|NCT04090606|Other|FTC Method Smoking Regimen|cigarettes are smoked by drawing 35 mL puff volumes over 2 s, with 60 s interval between puffs and no blocking of filter ventilation holes
15844048|NCT04090606|Other|Massachusetts Method Smoking Regimen|45-mL puffs drawn over 2 s, with 30 s interval between puffs and 50% blocking of filter ventilation holes
15844049|NCT04090606|Other|Health Canada Intense Smoking Regimen|55-mL puff volumes of 2-s duration, with 30 s interval between puffs and 100% blocking of filter ventilation holes
15844050|NCT04090593|Other|Patient Education 101: Mobile Health Education Tool|Intervention is interactive, mobile (tablet-or-smart-phone delivered), educational module that patients engage with during hospital admission.
15844051|NCT04090580|Diagnostic Test|Continuous glucose monitoring|"Subjects enrolled will be randomized 1:1 to either receive a daily dosage of dapagliflozin 10 mg and 2000 mg metformin for 12 weeks (n=18) or 2000 mg metformin (n=18). Patients who do not tolerate metformin at 2000mg dose will be downtitrated to 1500 mg daily. In case patients do not tolerate 1500 mg daily, they will be excluded.
~Both groups will be monitored for 7 days using either iPro™ CGM system (Medtronic, Northridge, CA) or Dexcom G6 CGM (Dexcom Inc, San Diego, CA). Basal continuous glucose monitoring will start at week 1 (first visit), and removed at day 7 and final continuous glucose monitoring will start at week 11 and removed 7 days after (final visit)."
15844052|NCT04090567|Drug|Cediranib|Given PO
15844053|NCT04090567|Drug|Ceralasertib|Given PO
15844054|NCT04090567|Drug|Olaparib|Given PO
15844055|NCT04090554|Device|Cytosponge™|The device consists of a spherical mesh enclosed in a gelatine capsule and attached to a string. The capsule is swallowed and allowed to reach the stomach . In the stomach the capsule is left for up to 5 minutes where it dissolves allowing the sponge to expand to its full size. It is then withdrawn using the suture, and as it does so collects cells from the lining of the oesophagus.
15844056|NCT04090541|Other|Rigid Tape|Non-Elastic Tape
15844057|NCT04090541|Other|Kinesiology Tape|Tape can be elongate only one direction
15844058|NCT04090541|Other|Biomechanical Tape|Tape can be elongate only two direction
15844093|NCT04090216|Device|Primary Percutaneous Coronary Intervention|Primary PCI will be done for patients with STEMI in both groups of patients
15844059|NCT04090528|Biological|pTVG-HP|pTVG-HP is a plasmid DNA, produced in E. coli, that encodes the complementary deoxyribonucleic acid (cDNA) for human prostatic acid phosphatase (PAP).
15844060|NCT04090528|Biological|pTVG-AR|pTVG-AR is a plasmid DNA
15844061|NCT04090528|Drug|Pembrolizumab|Pembrolizumab is a human programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with multiple different types of cancer.
15844062|NCT04090515|Behavioral|Project Health|This intervention involves a one-hour group meeting for six consecutive weeks.
15844063|NCT04090515|Other|Educational Video Control|This intervention involves a one-hour educational video control viewing for six consecutive weeks.
15844064|NCT04090502|Other|Dry needling in hamstring muscle trigger points|Participants with nonspecific mechanical low back pain will be assessed for the hamstring muscle. Subsequently, the most sensitive areas associated with the shortening of the muscle will be located and the technique will be applied to this area.
15844065|NCT04090502|Other|Dry needling in hamstring muscle not trigger points|Participants with nonspecific mechanical low back pain will be assessed for the hamstring muscle. Subsequently, the most sensitive areas associated with the shortening of the muscle will be located and the technique will be applied out of this area.
15844066|NCT04090476|Other|Exercise|During each of the exercise sessions the LSVT Big daily exercises will be performed along with functional tasks and gait/balance tasks. The functional tasks and gait/balance tasks will change weekly to monthly and all activities will be modified to the participant's mobility level.
15844067|NCT04090463|Radiation|Intraoperative radiotherapy|"IORT will be delivered as follows:
~Radical resection --> delivery of 10-15 Gy to the tumor bed
~Non radical resection --> delivery of 15-20 Gy to the tumor in situ"
15844068|NCT04090450|Radiation|chemo-radiotherapy|The study will not have a direct intervention. It will recruit patients who have had chemo-radiation as part of their standard of care treatment for rectal cancer.
15844069|NCT04090437|Procedure|Catheter ablation procedure|Catheter ablation procedure using Acutus mapping system
15844076|NCT04090398|Drug|Paclitaxel|Given IV
15844077|NCT04090398|Radiation|Radium Ra 223 Dichloride|Given IV
15844078|NCT04090385|Device|Transcranial Direct Current Stimulation|Participants will receive 15 sessions of Transcranial Direct Current Stimulation (tDCS) for 20 minutes each at 2 mA intensity, 5 times a week. The current will be delivered via saline-embedded sponge surface electrodes using a battery-powered neurostimulator (TCT-Research, Trans Cranial Technologies, Hong Kong). A small active specific electrode (5x5 cm) will be used to prevent coverage of adjacent areas, resulting in a current density of 0.08 mA / cm². These parameters are within the safe limits established in previous human studies.
15844079|NCT04090372|Device|evaluation of pre-op planning using Traumacad|The study will be compare pre-op planning with standard condition or with TraumaCad
15844080|NCT04090359|Device|Dual Mobility Implant|Patients in this intervention will receive a dual mobility implant
15844081|NCT04090359|Device|Conventional, single-bearing implant|Patients in this intervention will receive a conventional, single-bearing implant
15844082|NCT04090346|Procedure|Fecal Microbiota Transplant|Fecal Microbiota Transplant (FMT) is a procedure to replace beneficial bacteria which has been killed or suppressed in the colon.
15844083|NCT04090333|Other|Standard withdrawal therapy|All painkillers are abruptly stopped for a 2 months period.
15844084|NCT04090320|Device|CATERPILLAR™ Arterial Embolization Device|Placement of the CATERPILLAR™ Arterial Embolization Device for patients requiring arterial embolization in the peripheral vasculature.
15844085|NCT04090307|Behavioral|TLC Group Prenatal Care|TLC will start in the late first trimester or early second trimester and run for ~6-10 sessions. Groups of 2-10 consented women, with two or more GDM risk factors, will meet under the supervision of an obstetric provider (nurse practitioner or MD) and co-facilitator (health educator, nutritionist, or nurse) for two-hour sessions. A major focus of TLC will be education, and much of each visit will be spent on pregnancy, exercise/nutrition education, and behavioral health.
15844086|NCT04090294|Drug|Roflumilast|"Roflumilast is a phosphodiesterase (PDE) type 4 inhibitor will be prescribed for three month for the study group. the patients will then be assessed for improvement regarding exacerbation frequency , performance and pulmonary function test.
~patients will receive Roflumilast 500 Mcg. Tablet once daily for three months"
15844087|NCT04090281|Genetic|CYP2C19 genotyping|Upon hospital discharge, patients will undergo CYP2C19 genotyping to guide initial P2Y12 inhibitor selection. At 14 days, post discharge, patients will undergo on treatment platelet reactivity phenotyping to further guide deescalation of P2Y12 inhibitor therapy
15844088|NCT04090268|Other|Sport Therapy|Children and adolescent with malignant hemopathies will attend a 3 days/weekly combined training
15844089|NCT04090255|Procedure|Renal puncture|The use of a needle for entering pelvicalyceal system of the kidney and put a guide wire for further pcn
15844090|NCT04090242|Device|BD Diabetes Care Application (for mobile devices) PLUS use of BD Nano Pen Needle|Subjects in the Intervention Group will be instructed to use the DC-App and switch from their current pen needle to the BD Nano 2nd Gen Pen needle during their participation in the study. The app is intended to be used as a patient education tool and data logger to augment the diabetes care team.
15844091|NCT04090229|Drug|ASLAN004|Subcutaneous injections of ASLAN004 100 mg/mL will be administered into the thigh or abdomen, except for the 2 inches (5 cm) around the navel.
15844092|NCT04090229|Drug|ASLAN004 Placebo|Subcutaneous injections of ASLAN004 Placebo will be administered into the thigh or abdomen, except for the 2 inches (5 cm) around the navel.
15844336|NCT04088344|Dietary Supplement|isocaloric diet|a 7-day isocaloric diet
15844094|NCT04090203|Drug|Boiled Peanut Powder|Oral Immunotherapy will be administered utilizing a powder derived from boiled peanuts. Treatment will begin with an initial escalation day in which dosing is begun at 0.1 mg peanut protein and escalated to a final dose of 6 mg peanut protein. Doses are ingested orally. The subjects will continue daily oral ingestion of doses at home and return for updosing every 2 weeks to a final maintenance dose of 300 mg peanut protein. The subjects will continue daily oral ingestion of the peanut product for a minimum duration of 28 days before undergoing exit DBPCFC. At the conclusion of the study, patients will be offered continued maintenance therapy off study in line with current specialty standards.
15844095|NCT04090190|Drug|Oxybutynin, Solifenacin, Tolterodine, Sanctura or Toviaz|Study participants will be evaluated for urgency urinary incontinence and will be offered treatment with a standard of care anticholinergic medication for 6 weeks. All study participants will fill out the UDI-6 and two day bladder diary at baseline before starting anticholinergic medication treatment. Participants will then provide a urine sample and blood draw to be assessed for urinary microbiome and inflammation. Anticholinergic medication will be taken daily for 6 weeks and the same procedures (UDI-6 questionnaire, bladder diary, urine sample except the blood draw for assessment) will be performed at the 6-week time period.
15844096|NCT04090177|Behavioral|TEAM Wheels|A 1-month, peer-led, eHealth training program (TEAM Wheels) for individuals transitioning to manual wheelchair use to improve satisfaction with activity participation and related rehabilitation outcomes.
15844097|NCT04090138|Dietary Supplement|Setria performance blend|Oral capsules
15844098|NCT04090138|Dietary Supplement|Placebo|Oral capsules
15844099|NCT04090125|Behavioral|PAS Intervention|The PAS program will be initiated during the final usual care PT visits. The PAS content will be included within the last two routine PT visits (Sessions 1 and 2). Session 1 will emphasize the importance of PA in TKA recovery, work with participants to establish SMART goals regarding overall PA and provide community-based and other resources to support overall PA. Session 2 will include balance exercise content to improve joint loading symmetry and home exercises will be assigned. Then, PAS participants will receive a follow-up phone call after 4 weeks (to assist with activity progression and problem-solving) and an additional in-person visit after 8 weeks (to visually monitor exercise performance and re-assess proportional weight-bearing ability).
15844100|NCT04090125|Behavioral|Attention Control|This will include usual in-person post TKA PT followed by 2 additional contacts (Session 1 and 2) with the physical therapist. Session 1 (phone) will review recovery benchmarks, assessment of participants' daily activities and reminders about symptoms that should trigger contacting a medical professional. Session 2 (in-person) will involve physical performance tests and comparison to appropriate normative values.
15844101|NCT04090112|Drug|10% lidocaine sprayed|four puffs of 10% lidocaine sprayed at the cuff of ETT and four puffs at laryngeal inlet
15844102|NCT04090112|Drug|2% lidocaine intravenous|15 mg/kg of 2% lidocaine intravenous injection prior to extubation
15844103|NCT04090099|Other|Erector spina plane block|While the patient is in the sitting position, an area containing 2 cm lateral of the T5 spinous process will be cleaned with povidone iodine. A high frequency ultrasound linear probe covered with a sterile sheath will be placed 2 cm to the side of the T5 spinous process, first to the right or left. After demonstrating the T5 transverse process and the erector spinae muscle on top, the 22-gauge, 80 mm insulated Quincke-type needle will be inserted into the skin at an angle of about 30 degrees from the cranial to the caudal, using an in-plane technique. When the transverse process is touched, the needle is withdrawn and after a negative aspiration test with 0.5 mL of normal saline and after a hypo-echogenic display and hydrodissection, a local anesthetic solution will be applied to the fascia under the erector spinae muscle.
15844104|NCT04090086|Drug|JNJ-53718678|JNJ-53718678 suspension will be administered orally as per assigned treatment sequence.
15844105|NCT04090086|Drug|JNJ-64417184|JNJ-64417184 tablet will be administered orally as per assigned treatment sequence.
15844106|NCT04090073|Procedure|Electroacupuncture|As above
15844107|NCT04090073|Other|Fast-track Perioperative program|As above
15844108|NCT04090060|Behavioral|Practice Self-/Companion Exams|300 men and 50 couples will be randomized and encouraged to practice anal exams at home before Visit 2. Practice results will be elicited by staff. They will return for Visit 2 (six months after Visit 1). At Visit 2, they will complete a pre- and post-visit computer assisted self-interview. They will receive written instructions. After completing an anal self-exam or anal companion exam at home, they will record the results. At the clinic, they will have a Digital Anal Rectal Exam (DARE) by a clinician who will give the subject his results.
15844109|NCT04090060|Behavioral|Control Arm|300 individuals and 50 couples will be randomized to this arm. Following Visit 1, they will neither be encouraged nor discouraged from practicing self- or companion exam. They will return for Visit 2 (six months after Visit 1). They will receive written anal exam instructions. They will then complete the self- or companion exam at home, and record the results. At the clinic, they will receive a clinician DARE. Clinicians will give DARE results. Persons will take a post-exam computer-assisted self-interview. Persons in this arm (control) will be asked if they have performed exams between visits.
15844110|NCT04090047|Drug|PF-06700841|PF-06700841 oral tablets in 5mg and 25mg provided for a 30mg dose
15844111|NCT04090047|Drug|Itraconazole|200 mg oral solution administered as 20 milliliters(mL) (10 mg/mL)
15844113|NCT04090021|Drug|Esomeprazole 40mg|Use in a drug combination for H. pylori eradication
15844114|NCT04090021|Drug|Clarithromycin 500mg|Use in a drug combination for H. pylori eradication
15844115|NCT04090021|Drug|Metronidazole 500 mg|Use in a drug combination for H. pylori eradication
15844116|NCT04090021|Drug|Amoxicillin 1000 MG|Use in a drug combination for H. pylori eradication
15844117|NCT04090021|Drug|Levofloxacin 500mg|Use in a drug combination for H. pylori eradication
15844118|NCT04090021|Drug|Rifabutin 150 MG|Use in a drug combination for H. pylori eradication
15844119|NCT04090008|Drug|PRP gel|The PRP gel is applied on the ulcer twice per week
15844120|NCT04090008|Drug|Saline dressing|Normal saline is used for dressing of the ulcer twice a week
15844121|NCT04089995|Other|data collection|No intervention
15844122|NCT04089982|Drug|Varenicline|Chantix
15844123|NCT04089982|Drug|Placebo oral tablet|Placebo
15844126|NCT04089956|Other|No interventation|A retrospective cohort Observational study with no intervention
15844127|NCT04089943|Procedure|Revascularization operation|Participants will be randomized into an endovascular or open bypass procedure.
15844128|NCT04089943|Other|Control group|Healthy non-PAD participants will be recruited for the study.
15844129|NCT04089930|Diagnostic Test|Immunogenicity|anti-VZV IgG titer and cell-mediated immunity (VZV-stimulated T cell spots)
15844130|NCT04089917|Device|Q Aspiration Catheter|The Q Aspiration Catheter is indicated for use in the removal of fresh, soft emboli and thrombi in the neurovascular system.
15844131|NCT04089904|Drug|Pembrolizumab Injection|Patients will receive 3 cycles of pembrolizumab at 200mg intravenously on day 1 of a 3 week cycle. After 3 cycles the patients will undergo surgery
15844132|NCT04089878|Procedure|Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration|Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration
15844133|NCT04089878|Other|Standard Medical Treatment|Antibiotics, nutrition and supportive treatment
15844134|NCT04089865|Drug|Tranexamic Acid|Tranexamic acid (TXA) is an antifibrinolytic medication used to reduce bleeding in a variety of medical settings. Patients will be randomized to receive either oral or intravenous tranexamic acid.
15844135|NCT04089852|Drug|Nitrous oxide gas for inhalation|All inhaled gases will be administered via nasal mask using a portable nitrous oxide/oxygen (N2O/O2) machine. Environmental safety will be maintained with an N2O scavenger system and Porter Miniature Vacuum System. The treatment group will receive inhaled N2O/O2. The N2O will be gradually up-titrated to a goal ratio of 70/30 N2O/O2 and will be administered as outlined in the treatment arm description.
15844136|NCT04089852|Drug|Oxygen Gas for Inhalation|All inhaled gases will be administered via nasal mask using a portable nitrous oxide/oxygen (N2O/O2) machine. The control group will receive inhaled O2 alone. Control group participants will receive 100% O2 for two minutes prior to speculum placement. Inhaled oxygen will be administered continuously throughout the procedure as outlined in the control arm description.
15844137|NCT04089839|Other|Non-Interventional|Non-Interventional
15844138|NCT04089813|Drug|Metformin|Patients use metformin to control blood sugar
15844139|NCT04089800|Other|Mobile phone based multimedia application|The investigators shall develop a multimedia mobile health application using Java programming language, while the database that hosts multimedia messages shall be developed using SQlite. It shall be an offline (stand-alone) application following user-centered design approaches that involve incorporating input from pregnant women as prospective users. Pregnant women shall be provided with solar chargers to supplement electricity charging. The application has three major functionalities, appointment reminder function, calling function and the multimedia (Video and audio) function.
15844140|NCT04089787|Other|Intervention|Shortened antibiotic treatment of 5 days
15844141|NCT04089787|Other|Control|Antibiotic treatment of 7 days or longer at the discretion of the treating physician
15844142|NCT04089774|Behavioral|Adapted Physical Activity (APA)|Supported by an Adapted Physical Activity (APA), at the rate of 3 sessions per week supervised by the association SCO STE MARGUERITE, spread over 12 months
15844143|NCT04089761|Device|Nerivio|Nerivio™ is an FDA-authorized remote electrical neuromodulation (REN) device for the acute treatment of migraine with or without aura in patients 18 years old or above who do not have chronic migraine. The device delivers transcutaneous electrical stimulation to the upper arm to induce conditioned pain modulation (CPM) that activates a descending endogenous analgesic mechanism. The treatment is self-administered and controlled by a smartphone application.
15844144|NCT04089748|Combination Product|neoadjuvant chemotherapy with cisplatine|Tumors from patient having muscle invasive bladder cancer who benefit from neoadjuvant chemotherapy with cisplatine
15844145|NCT04089735|Drug|APP13007, 0.05%|APP13007 eye drop, 0.05%
15844146|NCT04089735|Drug|APP13007, 0.1%|APP13007 eye drop, 0.1%
15844147|NCT04089735|Drug|APP13007 Placebo, 0.05%|APP13007 eye drop, placebo 0.05%
15844148|NCT04089735|Drug|APP13007 Placebo, 0.1%|APP13007 eye drop, placebo 0.1%
15844149|NCT04089722|Drug|Deoxycholic Acid|The active ingredient in KYBELLA® is synthetic deoxycholic acid. Deoxycholic acid is a naturally occurring molecule in the body that aids in the breakdown and absorption of dietary fat.
15844150|NCT04089709|Behavioral|Well-arm Exercise|Patients randomized to the treatment arm will perform these exercises on the contralateral arm once daily for 3 months: wrist flexion and extension, ball or sock squeeze, wrist curls and biceps curls. Participants allocated to this study arm will be provided a print out of the exercises with detailed explanations and pictures of each exercise.
15844151|NCT04089696|Device|ExSprion|The primary objective is the validation of the ExSpiron© non-invasive monitor in patients diagnosed with ALS.
15844152|NCT04089683|Other|Swab stick|Swab sticks collected from Web Spaces, Scrub, Anterior Nares
15844153|NCT04089670|Behavioral|Online Acceptance and Commitment Therapy Intervention|"The intervention includes 8 modules (i.e, Away Moves, Letting Go of Control, Noticing Hooks, Stepping Back, Your Values, How You Want to Act, Goal Setting, and Making Commitments). Away Moves and Letting Go of Control, helps establish creative hopelessness, where one abandons futile struggles against negative internal experiences and accepts new solutions. These two modules also help identify experiential avoidance and focus on acceptance. Noticing Hooks and Stepping Back focus on defusion, self as context, and mindfulness. While, mindfulness is overtly addressed in the module Stepping Back it is weaved through each module. Your Values and How You Want to Act focus on helping participants identify their values. Goal Setting and Making Commitments focus on committed action. Each module ends with a practice assignment which participants are asked to engage in over the next week."
15844154|NCT04089657|Drug|Apatinib Mesylate|Apatinib 500mg qd, oral, taken half an hour after a meal
15844155|NCT04089657|Drug|Sintilimab|Sintilimab 200mg intravenously on day 1
15844156|NCT04089644|Device|closed-loop system|"Hypotension will be corrected by an automated system for vasopressor administration.
~Fluids will be given using a goal directed strategy (EV1000 Monitor, Edwards Lifesciences, Irvine, CA, USA)"
15844157|NCT04089644|Device|Manual adjustment|"Vasopressor agents will be manually adjusted (standard practice).
~Fluids will be given using a goal directed strategy (EV1000 Monitor, Edwards Lifesciences, Irvine, CA, USA)"
15844158|NCT04089631|Drug|Capecitabine|6 months capecitabine, in combination with oxaliplatin 3 to 6 months capecitabine
15844159|NCT04089618|Behavioral|MBLM|Complex 8 week Mind-Body program.
15844160|NCT04089605|Drug|dexamethasone implant|intravitreal dexamethasone implant injections in vitrectomized patients with DME
15844161|NCT04089605|Drug|Ranibizumab|intravitreal ranibizumab injections in vitrectomized patients with DME
15844162|NCT04089592|Drug|Dexmedetomidine|intravenous dexmedetomidine 0.6mcg/kg in 100ml normal saline 0.9%
15844163|NCT04089592|Drug|Fentanyl|intravenous fentanyl at 2mcg/kg in 100ml saline
15844164|NCT04089579|Biological|Cord Tissue Mesenchymal Stromal Cells|Human Umbilical Cord Tissue Derived Mesenchymal Stromal Cells (hCT-MSC), isolated and expanded from umbilical cord tissue from allogeneic unrelated donors. One dose of 6x10e6 cells/kg administered intravenously.
15844165|NCT04089579|Other|Placebo Infusion|Placebo comparative infusion
15844167|NCT04089553|Drug|AZD4635|Capsule
15844168|NCT04089553|Drug|Oleclumab|Oleclumab is supplied as a solution for infusion after dilution. The solution contains 50 mg/mL oleclumab in 25 mM histidine/histidine HCl, 240 mM sucrose, 0.03% (w/v) polysorbate 80.
15844169|NCT04089553|Drug|Durvalumab|Durvalumab will be supplied as a solution for infusion after dilution. The solution contains 50 mg/mL durvalumab, 26 mM histidine/histidine HCl, 275 mM trehalose dihydrate, and 0.02%(w/v) polysorbate 80.
15844170|NCT04089540|Procedure|New intubation method|
15844171|NCT04089540|Procedure|Conventional intubation method|
15844172|NCT04089527|Drug|CC-95775|CC-95775
15844173|NCT04089514|Drug|Adalimumab|Administered as specified in the treatment arm
15844174|NCT04089501|Diagnostic Test|Stool collection|Stool will be collected from subjects who have been diagnosed with IBD or whom small intestinal, colonic or ileocolonic and have signed consent for the control group. Stool will be self-collected or through routine colonoscopy procedure.
15844175|NCT04089501|Diagnostic Test|Biopsy collection|3 additional biopsies (for research purposes) will be taken from patients who undergo colonoscopy as per standard of care
15844176|NCT04089488|Other|Medical Chart Review|Correlative studies
15844177|NCT04089488|Other|Survey Administration|Respond to surveys
15844178|NCT04089475|Device|Dermoscope|Dermoscopy is a noninvasive diagnostic tool that permits the visualization of morphological features that are not visible to the naked eye thus representing a link between macroscopic clinical dermatology and microscopic dermatopathology.
15844179|NCT04089462|Behavioral|"Five sessions per period - Two sessions per period"|"Period 1: 5 exercise sessions on 5 consecutive days (4 min anaerobic exercise and 30 min aerobic exercise per session)
~Period 2: 2 exercise sessions within a 5-day period (10 min anaerobic exercise and 75 min aerobic exercise per session)"
15844180|NCT04089462|Behavioral|"Two sessions per period - Five sessions per period"|"Period 1: 2 exercise sessions within a 5-day period (10 min anaerobic exercise and 75 min aerobic exercise per session)
~Period 2: 5 exercise sessions on 5 consecutive days (4 min anaerobic exercise and 30 min aerobic exercise per session)"
15844181|NCT04089449|Drug|PRT811|PRT811 will be administered orally
15844182|NCT04089436|Diagnostic Test|CSF sampling|CSF sampling by lumbar puncture
15844183|NCT04089436|Diagnostic Test|Blood sampling|Blood sampling by blood test
15844184|NCT04089436|Diagnostic Test|Nasopharyngeal and rectal sampling|Nasopharyngeal and rectal sample by swabbing
15844185|NCT04089423|Device|Fujifilm SILVAMP TB LAM|Fujifilm SILVAMP TB LAM detects the presence of lipoarabinomannan (LAM) in urine with a visually read lateral flow test that uses silver amplification.
15844186|NCT04089410|Device|Hyperthermic Fitness Treatment (HFT)|The Hyperthermic Fitness Treatment uses Alfa Basic capsule, an ergonomic camera in which a participant may take a lying position and undergo hyperthermia procedures (infrared heating with intracapsule temperature increase up to 80 degrees C◦), the head being outside the camera blown by cool air with a built-in ventilator. HFT is comparable to dry sauna bathing. Core body temperatures will be raised to 37.5-38.5°C◦. Recommended duration of one HFT session is 40 min. All the HFT group participants while undergoing sessions in the Cocoon will be dressed in bathing suits.
15844187|NCT04089410|Device|Placebo Hyperthermic Fitness Treatment|Attenuated heating with less heat set (20-30 degrees C◦). This results in no increase of core body temperature. The participant will still feel heat and will see similar lighting and hear similar sounds as those occurring during actual HFT, and will be in the capsule for the same period of time.
15844188|NCT04089410|Other|Physical Examination|"Resting hearth rate (HR), Systolic and Diastolic blood pressure (SBP and DBP) values are measured twice in supine position using an automatic tonometer after 5 min of rest.
~Body mass (BM) and height are measured to calculate Body Mass Index. Body composition is assessed with the use of portable body-impedance-meter for the whole body impedance-analysis.
~Body core temperature, Blood pressure (BP) and Heart rate (HR) are measured before and right after each session. Arterial oxygen saturation (SpO2) and HR is monitored continuously by the use of a pulse oximeter, attached to the index fingertip of non dominant hand."
15844189|NCT04089410|Other|Assessment of Cardiorespiratory Fitness|An assessment of exercise tolerance and cardiorespiratory fitness (ET, CRF) is carried out with the use of Cardiopulmonary Exercise Test - CPET). Testing is carried out using a gas analyzer and an Intertrack treadmill. Evaluation of gas exchange parameters conducted according to a given program - Cardiopulmonary load testing.
15844190|NCT04089410|Other|Autonomic Balance, Orthostatic and Hypoxic tolerance|"Evaluation of Autonomic balance is assesed using Heart Rate Variability (HRV) analysis. The HRV test relies on a 5-min RR interval (time in milliseconds between two R waves of the electrocardiogram complex) recorded at rest for 5 min supine (SU) followed of 5 min resting time. Measurement of the interval duration between two R waves of the cardiac electrical activity are performed with a HR monitor.
~Orthostatic tolerance is assessed after ANS balance assessment by HRV analysis to continue RR intervals registration for 3 min after participant was asked to stand up taking a vertical position near the couch.
~The individual sensitivity to hypoxia is determined by conducting a 10-minute hypoxic test (HT) - breathing through a facial mask by a gas mixture with 11% of O2, with minute-by-minute monitoring of HR and hemoglobin saturation by oxygen (SaO2). Arterial blood pressure is recorded before and after HT."
15844191|NCT04089410|Other|Psychological Testing|"Medical Outcomes Study Short-Form 36-Item Health Survey (SF-36), which is a self-completed quantity of health-related QoL.
~Participants are asked to complete the Pittsburgh Sleep Quality Index (PSQI), a retrospective self-report measure assessing their quality of sleep during the last three weeks preceding the study.
~Anxiety level is estimated by using State and Trait Anxiety Scales (SA and TA) developed by Ch. Spielberger
~Subjective Ratings of Thermosensation and Pain.Participants rate their comfort, thermosensation, and pain by fixing results in visual-analogous scale (VAS) while passing each of HFT treatment."
15844192|NCT04089410|Other|Measurement of Blood Markers|Periferal venous blood (10 ml) sumples of the fastest (overnight fast) study subjects are withdrawn by a qualified laboratory technician via aseptic technique from the antecubital vein in the sitting position, using sterile needles and are collected. Serum BDNF, HGH, HSPs (60, 70, 90) concentrations are determined.
15844193|NCT04089397|Device|Light Therapy|Five weeks of light therapy, with 3 weekly sessions of 30 minutes, to be performed between 8:00 to 10:00, the days of dialysis
15844194|NCT04089384|Other|Control Group|Will receive individualized dietary plan - alimentary reeducation and micropore containing a point made with a black gel pen that will be placed in the ear
15844195|NCT04089384|Other|Auriculotherapy Group|Will receive individualized diet plan - diet reeducation and auricular therapy method with strategic points for obesity
15844196|NCT04089384|Other|Placebo group|Will receive individualized diet plan - diet reeducation and sham points, points not indicative for the proposed treatment).
15844197|NCT04089371|Device|ReUnion Total Shoulder Arthroplasty (TSA)|The ReUnion RFX System includes a Reversible Fracture Stem (RFX Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended for cemented use only.
15844198|NCT04089371|Device|ReUnion Reverse Shoulder Arthroplasty (RSA)|The ReUnion RFX System includes a Reversible Fracture Stem (RFX Stem) that can utilize either the ReUnion Total Shoulder Arthroplasty (TSA) or ReUnion Reverse Shoulder Arthroplasty (RSA) humeral and glenoid components and is indicated for use as a hemi, total or reverse shoulder replacement. The ReUnion RFX stem is intended for cemented use only.
15844205|NCT04089345|Drug|Ustekinumab|All patients will receive intravenously (IV) ustekinumab ~6mg/kg at baseline and subcutaneously (SC) ustekinumab 90mg every 8 weeks thereafter until Week 48.
15844206|NCT04089332|Other|Oral Glucose Tolerance Test|Eligible subjects will undergo MRI scanning before and after oral glucose tolerance test.
15844207|NCT04089332|Device|3 Tesla MRI|A 3 Tesla MRI will be used to assess brain structure, quantify cerebral blood flow and capture cerebral vessel structure at designated time points throughout the study visits.
15844208|NCT04089332|Device|Intravenous Catheter|A blood sampling IV catheter will be used to draw blood samples at specific time points throughout each study visit to measure concentrations of glucose and insulin.
15844209|NCT04089332|Other|Cognitive Tests|A battery of cognitive tests will be completed by the subject.
15844210|NCT04089319|Other|Music recording|Participants will listen to music for 45 minutes while they rest with acupuncture needles in place.
15844211|NCT04089319|Other|Mindfulness recording|Participants will listen to a recording of mindfulness for 15 minutes and then listen to music for 30 minutes while they rest with acupuncture needles in place.
15844212|NCT04089280|Dietary Supplement|Sanprobi Barrier-multispecies probiotic|"Multi-strain probiotic Sanprobi Barrier (Bifidobacterium lactis W52, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus lactis W19, Lactobacillus lactis W58, Lactobacillus acidophilus W37, Bifidobacterium bifidum W23, Lactobacillus salivarius W24) or placebo. Patients will be randomized to one of the two products (A or B) each containing probiotic/placebo and administered for 12 weeks. After 12 weeks of supplementation, the probiotic/placebo product A or B will be discontinued and reintroduced again after next 4 weeks - patients will be switched to the other A or B group of probiotic/placebo arm. Patients will be administered with 4 capsules per day for 24 weeks (12 weeks for group A probiotic/placebo and 12 weeks for group B probiotic/placebo allowing 4 weeks washout between the group assignment)."
15844213|NCT04089280|Other|Placebo Comparator|Carrier material of Sanprobi Barrier-multispecies probiotic product, not containing bacterial strains,similar appearance as the probiotic
15844214|NCT04089267|Drug|TPO|
15844215|NCT04089254|Behavioral|Inpatient Psychiatry|Inpatient hospitalization to treat and stabilize suicidal thoughts and behavior.
15844216|NCT04089254|Behavioral|Outpatient Crisis Intervention Clinic|Outpatient psychiatric clinic that provides crisis intervention to treat and stabilize suicidal thoughts and behavior.
15844217|NCT04089241|Other|Contrast 3D Ultrasound|an ultrasound examination which will include a 3D reconstruction and thereafter CEUS will be performed using SONOVIEW contrast agent
15844218|NCT04089228|Other|Kinesiotaping|Total of 4 sessions on upper trapezius trigger points on alternate days.
15844219|NCT04089228|Other|Integrated Neuromuscular Inhibition Technique|Sustain Pressure. Strain Counter-strain (for 90 sec) Passive Isometric Relaxation (PIR) (6-10 sec hold, 4 reps)
15844220|NCT04089215|Biological|CD19-targeted Chimeric Antigen Receptor (CAR) T Cells|JWCAR029 be administered at dose level: 1 x 10^8 CAR+T cells and 1.5 x 10^8 CAR+T cells
15844221|NCT04089202|Other|eConsult|Completion of electronic consult utilizing data collected from flash glucose monitoring
15844222|NCT04089202|Other|Standard of care|Care by the Endocrinologist is provided as would typically be done, taking into account patient factors and preferences.
15844223|NCT04089189|Drug|IMP4297|IMP4297 100mg PO QD
15844224|NCT04089176|Drug|Carbetocin|carbetocin 100 mcg + RLS solution 10 ml injected directly into the vein over 2 min
15844225|NCT04089176|Drug|oxytocin|oxytocin 20 IU diluted in 1000 ml of RLS solution administered intravenously at rate 120 ml/hr x 8 hr
15844337|NCT04088344|Dietary Supplement|Hypercaloric diet|A 7-day hypercaloric diet supplemented with carbohydrate-rich food (+ 50% of the subject's energy needs).
15844226|NCT04089163|Biological|Toca 511|Toca 511 consists of a purified retroviral replicating vector encoding a modified yeast cytosine deaminase (CD) gene. The CD gene converts the antifungal drug, flucytosine (5-fluorocytosine; 5-FC) to the anticancer drug 5-fluorouracil (5-FU) in cancer cells that have been infected by the Toca 511 vector.
15844227|NCT04089163|Drug|Toca FC (extended-release formulation of flucytosine)|Toca FC is an extended-release formulation of flucytosine and is supplied as 500 mg tablets
15844233|NCT04089137|Behavioral|ASAP (Alcohol and Sexual Assault Prevention)|This is an integrated social norms-based personalized feedback intervention for college students targeting alcohol misuse and sexual assault.
15844234|NCT04089124|Procedure|surgery of zone 2 cut flexor repair|we will repair tendon of FDP. use 6 strand technique using PDS 4/0 core suture - vicryl 5/0 running suture
15844235|NCT04089111|Other|Minute volume target of 100%|Patients will be ventilated to reach minute volume target of %100 (100 ml per ideal body weight).
15844236|NCT04089111|Other|Minute volume target to reach PaCO2 less than 45% (high tidal volume)|Patients will be ventilated to reach minute volume target associated with PaCO2 less than 45%.
15844237|NCT04089098|Diagnostic Test|passive leg raising versus mini volume challenge|Blood samples will be collected and ultrasound evaluation of renal perfusion conducted in study participants immediately before conducting passive leg raising (PLR). PLR will then be carried out on study participants, followed by MVC. PLR- and/or MVC-responsive patients will receive a further 700 ml fluid immediately after the MVC. Renal perfusion will be further assessed 1 and 24 hours after the MVC.
15844238|NCT04089085|Behavioral|STRONGer Together|STRONGer (Successes/Strengths, Triggers, Remember your medications, Ongoing communication, Never give up!, Gratitude) Together is an asthma educational and cognitive behavioral skills intervention for children between 8 - 12 years of age. The intervention is implemented in small groups in 30-minute sessions.
15844239|NCT04089072|Drug|Methylene Blue|"Prior to the initiation of the randomized treatment, the subject will have received 2 vasopressors ( norepinephrine and vasopressin), they will be initiated on IV hydrocortisone . Once the patient is unable to maintain a mean arterial pressure of >65mmHg and the hydrocortisone has been administered there will be an addition of a third-line vasopressor.
~Patients enrolled in the intervention group will receive ProvayBlue® and Patients enrolled in the control group will receive Phenylephrine infusion as a third line vasopressor in the treatment of septic shock."
15844240|NCT04089072|Drug|Phenylephrine|"Prior to the initiation of the randomized treatment, the subject will have received 2 vasopressors ( norepinephrine and vasopressin) already , they will be initiated on IV hydrocortisone . Once the patient is unable to maintain a mean arterial pressure of >65mmHg and the hydrocortisone has been administered there will be an addition of a third-line vasopressor.
~Patients enrolled in the intervention group will receive ProvayBlue® and Patients enrolled in the control group will receive Phenylephrine infusion as a third line vasopressor in the treatment of septic shock."
15844241|NCT04089059|Device|Cordella™ Pulmonary Artery Sensor System|"The Cordella PA Sensor System (CorPASS) is intended to measure, record, and transmit pulmonary artery pressure (PAP) data from NYHA Class III heart failure patients at home to clinicians for assessment and patient-centered heart failure management and comprises of seven subsystems that operate together to take daily Pulmonary Artery Pressure (PAP) readings at a patient's home and transmit the results to a care provider for evaluation.
~Cordella Sensor
~Cordella Delivery System
~myCordella Patient Reader
~Reader Dock
~Cordella Calibration Equipment (CalEQ)
~myCordella Hub
~Cordella Data Analysis Platform (CDAP)"
15844242|NCT04089059|Device|Cordella™ Pulmonary Artery Sensor System|"The Cordella PA Sensor System (CorPASS) is intended to measure, record, and transmit pulmonary artery pressure (PAP) data from NYHA Class III heart failure patients at home to clinicians for assessment and patient-centered heart failure management and comprises of seven subsystems that operate together to take daily Pulmonary Artery Pressure (PAP) readings at a patient's home and transmit the results to a care provider for evaluation.
~Cordella Sensor
~Cordella Delivery System
~myCordella Patient Reader
~Reader Dock
~Cordella Calibration Equipment (CalEQ)
~myCordella Hub
~Cordella Data Analysis Platform (CDAP)"
15844243|NCT04089046|Behavioral|TEAM-UP for Teens|TEAM-UP for Teens pairs school-based directly observed therapy (DOT) of daily preventive asthma medications with specialist care and ongoing self-management support using live, real-time telemedicine through school.
15844244|NCT04089046|Behavioral|Enhanced Care (EC)|Teens in the EC group will receive a symptom assessment and asthma education materials at baseline, and their PCPs will be contacted by facsimile or email to recommend DOT of preventive asthma medication through school as well as referral to an asthma specialist. Systematic reminders will be sent to the family and PCPs to schedule recommended healthcare visits and consider specialist referral at the same intervals as the TEAM-UP group's virtual visits.
15844245|NCT04089033|Procedure|Pneumatic Retinopexy|The PnR technique is performed as per the PIVOT trial under local anaesthetic. First, patients will undergo a thorough scleral-depressed peripheral retinal examination to identify all pathologic features. Second, laser retinopexy will be applied to all breaks, lattice degeneration, or both in the attached retina before gas injection. Third, breaks in the detached retina will be treated with cryotherapy before gas injection or (preferably) laser retinopexy 24 to 48 hours after gas injection, with additional laser retinopexy applied at any point per surgeon discretion. Finally, anterior chamber paracentesis will be used to express as much fluid as safely possible (generally 0.3ml), followed by intravitreal injection of 100% SF6 (ideally 0.6 ml). Patients will be positioned face down for 6 hours and then raise their head 30 degrees every hour (steam roll) and then positioned to the responsible break.
15844338|NCT04088344|Other|Liquid meal|
15844246|NCT04089033|Procedure|Pars Plana Vitrectomy|For PPV, a standard 3-port PPV (23 or 25-gauge) will be performed, including posterior hyaloid detachment, core vitrectomy and 360 peripheral vitreous shave. Subretinal fluid will be drained either through the peripheral break or through a posterior retinotomy with use of heavy liquid to assist with appropriate drainage at the discretion of the responsible surgeon. A complete air-fluid exchange will be performed. Endolaser Retinopexy or transconjunctival cryopexy will be performed to treat any retinal pathology, including lattice degeneration and breaks in the attached and detached retina. A iso-expansible concentration of SF6 or C3F8 gas will be injected at the completion of the surgery. Choice of gas will be at the discretion of the responsible surgeon. Patients will be positioned immediately face down for the first 24 hours and then according to the position of the responsible break.
15844247|NCT04089020|Behavioral|Support for walking to school|5 modules that address psychosocial skills, with ongoing text messaging.
15844248|NCT04089007|Device|SOmNI app|In addition to allowing users to track sleep behaviours across the four-week intervention period, the SOmNI app will also provide messaging via alerts and tips to outline the importance of sleep to health, suggest optimal sleep timing/duration, and suggest sleep promotion strategies. Daily review questions in the app will help the participants link changes in sleep behaviours to changes in health outcomes. As well, when goals related to sleep extension are met, the SOmNI rewards program awards points to the participant and these points can then be redeemed in $5 increments to a maximum of $40 for gift certificates.
15844249|NCT04089007|Other|Control group|The research assistant will advise the participant to increase the amount of nighttime sleep achieved but will not give any sleep hygiene advice or instructions for moving their bedtime earlier.
15844250|NCT04088994|Other|AOT Pathological Model Experimental Group|The children will participate in a rehabilitation intervention based on the observation of unimanual and bimanual actions performed by a model with the same degree of motor impairment, but an improvement on the participant's current abilities.
15844251|NCT04088994|Other|AOT Healthy Model Control Group|The children assigned to the healthy group will participate in a rehabilitative protocol based on the AOT observing unimanual and bimanual actions performed by a healthy model
15844252|NCT04088981|Behavioral|Dietary intervention|low-fat vegan diet and a portion controlled diet.
15844253|NCT04088968|Behavioral|Prehabilitation|Patients screened positive for minimun 1 SNAP factor will be offered enrollment in the study and have an individualized plan for the prehabilitation intervention.
15844254|NCT04088955|Other|DigiMeds|Digitized Capecitabine
15844255|NCT04088942|Other|High-intensity smoking cessation intervention|"Varenicline for 12 weeks - Day 1-3: 0.5 mg daily. Dag 4-7: 0.5 mg two times daily. Thereafter 1 mg 2 times daily.
~Group-sessions in 6 months:
~Preparation phase: 5 sessions Day 1-14: 5 sessions Day 15-30: 5 sessions Day 31-60: 5 sessions Day 61-90: 5 sessions Day 90-180: 5 sessions c) Hotline and scheduled phone consultations:
~A hotline is established which the high-intensity group can call.
~Weekly calls to all patients in the project for 26 weeks. Call for 5-10 min. If the patient has not had relapse, there will be called week 34 and week 42. If the patient has had relapse, calls continue until relapse-free for 10 weeks, then week 34 and week 42.
~d) Buddy-arrangement: i. Patients who have completed the program and have become smoke-free, are matched with new ones in the program. A meeting frequency of approx. every 7-14 days. The first patients are matched with patients from pulmonary medical outpatient clinic who have ceased smoking."
15844256|NCT04088942|Drug|Low-intensity smoking cessation intervention|Varenicline prescribed for 12 weeks - Day 1-3: 0.5 mg daily. Dag 4-7: 0.5 mg two times daily. Thereafter 1 mg 2 times daily.
15844257|NCT04088929|Drug|CBD|A water-soluble sublingual tablet containing 20 mg of cannabidiol (CBD) and 0.1 mg of a proprietary blend of terpenes.
15844258|NCT04088903|Drug|Daratumumab|>Daratumumab 16 mg/kg intravenous weekly for 8 weeks and then every other week for 2 doses.
15844259|NCT04088890|Drug|Fludarabine|Fludarabine 30 mg/m2
15844260|NCT04088890|Drug|Cyclophosphamide|Cyclophosphamide 500 mg/m2
15844261|NCT04088890|Drug|CD22 CAR|Autologous T cells transduced with lentiviral vector (CD22.BB.Z) Chimeric Antigen Receptor (CD22 CAR). Autologous CD22 CAR T cells will be administered intravenously at Dose Level 1 in subjects with ALL. Autologous CD22-CAR T cells will be administered in 3 escalating doses (Dose Level 1, 2, and 3) in subjects with aggressive B-cell NHL to determine MTD/RP2D
15844262|NCT04088877|Behavioral|Exercise|The participants will attend the exercise facility at Wellspring two times a week. Sessions are completed under the supervision of an exercise physiologist and the duration of each session ranges from 1.0 - 1.5 hours. Each session includes a warm up on an aerobic exercise machine, a full body progressive RET program followed by balance and stretching exercises.
15844263|NCT04088877|Behavioral|Art Sculpting Class|The sculpting program will take place once a week for 2 hours over an 8-week period. Sessions will be themed around body image and facilitated by an artist and registered psychologist who will lead the group in art techniques and self-reflection, respectively. Each group session will focus on a theme related to body image, and the participants will have the opportunity to reflect through their art and social interactions with one another.
15844264|NCT04088864|Drug|Fludarabine|Fludarabine is a purine antagonist antimetabolite
15844265|NCT04088864|Drug|Cyclophosphamide|Cyclophosphamide is a nitrogen mustard derivative alkylating agent
15844266|NCT04088864|Drug|Autologous CD22 CAR T|Autologous T cells transduced with lentiviral vector (m971BBZ) Chimeric Antigen Receptor (CD22 CAR)
15844267|NCT04088851|Drug|Metformin|Type 2 Diabetics with prescribed Metformin therapy (1 g / day) will pause the medication for 2 weeks and then continue the anti-diabetic treatment again. Aim is to measure the gluconeogenic precursor fluxes with and without metformin therapy.
15844268|NCT04088838|Other|Pain tracking app|In this study no clinical interventions are made. Patients scheduled for surgery will be treated according to the standard of care. All patients enrolled will have an application installed to track their pain symptoms through short daily and weekly questionnaires.
15844269|NCT04088825|Other|CONUT screening system|"CONUT has been working from june of 2010 and it has detected risk of malnutrition in 32% of the evaluated patients. The method collects information from databases of Admission Service (affiliation, age, date) and Laboratory (albumin, cholesterol, total lymphocytes) and generates, in the report of analytical results, alert information about each patient's nutritional risk and also nutritional recommendations based on the risk identified."
15844339|NCT04088344|Radiation|PET imaging|
15844340|NCT04088344|Other|perfusions of stable tracers|
15844270|NCT04088812|Other|Placebo meat derivative + Placebo satiating compound|Subjects will consume 60 g of meat derivative placebo in a brunch type meal with 25 g of the satiating compound placebo diluted in water
15844271|NCT04088812|Other|Placebo meat derivative + Satiating compound|Subjects will consume 60 g of meat derivative placebo in a brunch type meal with 25 g of the satiating compound diluted in water
15844272|NCT04088812|Other|Experimental meat derivative + Placebo satiating control|Subjects will consume 60 g of the experimental meat derivative in a brunch type meal with 25 g of satiating compound placebo diluted in water
15844275|NCT04088773|Diagnostic Test|blood biomarkers|biomarkers to distinguish fibrotic vs non-fibrotic CD lesions
15844276|NCT04088773|Diagnostic Test|stool biomarkers|fecal biomarkers of inflammation, mucosal inflammation
15844277|NCT04088773|Diagnostic Test|MRI imaging|MRI imaging to detect bowel wall fibrosis and to detect inflamed, non-fibrotic from inflamed, fibrotic bowel
15844278|NCT04088760|Drug|TCRαβ+/CD19+ depleted allogeneic hematopoietic stem cell transplant (HSCT)|The majority of TCRαβ+ T cells and CD19+ B cells will be removed from the allogeneic graft utilizing the CliniMACS® immunomagnetic selection device (Miltenyi Biotec). The depletion process involves two phases; cell labeling (phase 1) and the automated immunomagnetic depletion process (phase 2). The CD34+ dose may be adjusted by the need to not exceed the TCRαβ+CD3+ dose threshold.
15844279|NCT04088747|Diagnostic Test|Ultrasound Imaging|B-mode ultrasound pictures of the upper Trapezius were collected from both left and right sides.
15844280|NCT04088734|Drug|ABO-102|Single dose of ABO-102 (scAAV9.U1a.hSGSH) administered by intravenous injection through a peripheral limb vein at a dose of 3 X 10^13 vg/kg
15844281|NCT04088721|Biological|AD17002|LTh(αK) as immunomodulator
15844282|NCT04088721|Other|Formulation Buffer|Formulation buffer
15844283|NCT04088708|Other|Aerobic Exercise Training|Each session will last 20 to 60 minutes depending on the stage of progression (shorter duration in the first few weeks). Sessions will occur on nonconsecutive days of the week. Moderate-intensity, continuous aerobic exercise will be used to target large muscle groups (e.g., legs) with the principal goal of increasing cardiorespiratory fitness. Exercise intensity will be gradually increased. To mitigate stagnation and support continued improvement of cardiorespiratory fitness, high-intensity interval exercise will be added in later weeks of the intervention.
15844284|NCT04088708|Other|Attention Control|The flexibility/toning control condition will be delivered using the same frequency as the aerobic condition (i.e., 3 times per week) and use light resistance bands of least difficulty. The flexibility/toning sessions will last about 40 minutes, be led by trained exercise specialists. Flexibility/toning activities will target the head/neck, shoulder, elbow/forearm, hand/wrist, trunk/hip, and ankle/foot. The progression of activities over the 10-week period will involve performing additional exercises and sets along with using progressively thicker elastic resistance bands (i.e., Thera-bands) that provide minimal resistance.
15844285|NCT04088695|Other|Video through a web page|Participants will see a video about blood donation.
15844286|NCT04088695|Other|Informative text|Participants will see a brief text about blood donation.
15844287|NCT04088682|Behavioral|Quality improvement strategies and tools|Quality improvement strategies and tools
15844288|NCT04088669|Other|Home-based Pulmonary Rehabilitation|Patients will admit a home-based pulmonary rehabilitation program for 8 weeks, with a minimum of 3 days per week and one session of this is under the supervision of a physiotherapist. The pulmonary rehabilitation program includes stretching exercises, strengthening exercises for upper and lower extremities, breathing exercises and aerobic exercises (walking). All of these exercises will be equipped with equipment that the patients can easily provide at home. In addition, patients will be provided with a pedometer and exercise diary.
15844289|NCT04088669|Other|Education and Recommendations|The control group will be given a training session on the course of the disease and the correct inhaler use and will be given booklets on breathing exercises, aerobic exercises (walking) and physical activity recommendations for a minimum of 2-3 days per week for 8 weeks. Patients will be given a pedometer and exercise diary.
15844290|NCT04088656|Other|Systems Analysis and Improvement Approach for Hypertension Screening and Treatment Optimization|The Systems Analysis and Improvement Approach to Optimize the Hypertension Care Cascade for People Living with HIV (SAIA-HTN) is a five-step systems analysis and iterative improvement cycle intervention which will be implemented by study nurses and district managers in intervention facilities. Components of the intervention include joint care cascade analysis, patient flow mapping and continuous quality improvement, aimed to incrementally improve hypertension screening, diagnosis, treatment and care in the HIV+ population at intervention health facilities.
15844291|NCT04088643|Device|transcranial alternating current stimulation|The alternating current is administered through medical grade conductive pads that are produced specifically for the Nexalin technology. The pads are places on the forehead and behind each ear, and are connected to the Nexalin device with thin cables. Intervention will be implemented with a tACS device with 4Hz frequency and a peak-to-peak amplitude of 15mA, 30 one-hour sessions in 3 weeks (21 days).
15844292|NCT04088643|Device|sham stimulation|Electrodes will also be put on patient's forehead and behind each ear. The sham stimulator has the exactly same appearance with the true stimulator. Participants and operators cannot determine whether the stimulator is true based on its appearance or patients' feelings. However, when the device is started, no current flows through the electrodes. Participants in this controlled group will also receive sham stimulations with 30 one-hour sessions in 21 days.
15844293|NCT04088630|Drug|Fingolimod 0.5 mg|A single dose of 0.5 mg oral fingolimod within 24 hours of symptom onset
15844294|NCT04088630|Drug|Placebo|A single oral placebo pill within 24 hours of symptom onset
15844295|NCT04088630|Other|Standard of care|Standard of care protocol for the treatment of spontaneous ICH
15844341|NCT04088344|Device|Indirect calorimetry|
15844296|NCT04088617|Dietary Supplement|Ketone monoester|Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior a 2-hour high carbohydrate mixed meal tolerance test.
15844297|NCT04088617|Dietary Supplement|Placebo|Acute ingestion of a taste-matched placebo prior a 2-hour high carbohydrate mixed meal tolerance test.
15844298|NCT04088604|Drug|LY01610 ( Irinotecan hydrochloride liposome injection )|Part1-Dose Escalation and Part1-Dose Extension : subjects take LY01610;
15844299|NCT04088604|Drug|LY01610 ( Irinotecan hydrochloride liposome injection ) with 5-Fu（Fluorouracil Injection）|Part2-Dose Escalation and Part2-Dose Extension : subjects take LY01610 with 5-Fu;
15844300|NCT04088604|Drug|Irinotecan Hydrochloride Injection（CAMPTO®）|Irinotecan Hydrochloride Injection（CAMPTO®） pharmacokinetics comparative study
15844303|NCT04088578|Other|Training|Controlling movement of an object on computer screen by adjusting muscle activity.
15844304|NCT04088578|Other|Vagus Nerve Stimulation|Recruits the auricular branch of the vagus nerve which activates brain structures that release chemicals mediating cortical plasticity.
15844305|NCT04088578|Other|Sham Stimulation|Sub-threshold stimulation that does not activate neural structures.
15844306|NCT04088565|Other|Paired-Associative Stimulation (PAS)|Simultaneous activation of connections in motor cortex via stimulation to the nerves and brain.
15844307|NCT04088565|Other|Vagus Nerve Stimulation (VNS)|Recruits the auricular branch of the vagus nerve which activates brain structures that release chemicals mediating cortical plasticity.
15844308|NCT04088565|Other|Sham Stimulation|Sub-threshold stimulation that does not activate neural structures.
15844311|NCT04088539|Behavioral|AWARD advice|Ask about smoking history, Warn about the high risk of smoking, Advise to quit as soon as possible, Refer to the smoking cessation services, and Do it again (if the smokers refused to set quit date)
15844312|NCT04088539|Behavioral|Video-based health education|Educational videos on smoking and health will be developed to improve the knowledge of CSD smokers. The videos aim to raise their awareness on these important health topics and acquire effective cessation methods. The effectiveness of the educational videos will be evaluated by pre- and post-tests through a self-administered survey that assess the changes in knowledge related to smoking hazards, benefits of quitting, and methods to quit smoking.
15844313|NCT04088526|Combination Product|intervention group|Through effective intervention combined with drugs and dietary guidance within 3 to 6 months, all the observation markers including blood pressure and laboratory results will reach the target target value.
15844314|NCT04088513|Drug|Aspirin|This group will receive a 100 mg/day aspirin plus clopidogrel placebo for 90 days.
15844315|NCT04088513|Drug|Clopidogrel|This group will receive a 75 mg/day clopidogrel plus aspirin placebo for 90 days.
15844316|NCT04088500|Biological|Nivolumab|Specific dose on specific days
15844317|NCT04088500|Biological|Ipilimumab|Specific dose on specific days
15844318|NCT04088487|Behavioral|New in Town-Interner Intervention for Migrants|New in Town is an internet intervention for migrants that aims at increasing social self-efficacy. Exercises in the intervention are based on the principles of Cognitive Behavioral Therapy and relate to four sources of self-efficacy beliefs-mastery experiences, vicarious experiences, verbal persuasions, and emotional and physiological states (Bandura, 1997).
15844319|NCT04088474|Dietary Supplement|Vigiis 101-LAB|examined the effects of the Vigiis 101-LAB capsules (5 billion CFU/day)
15844320|NCT04088474|Dietary Supplement|Placebo|Maltodextrin was used as a placebo
15844321|NCT04088461|Drug|Linagliptin / Metformin Oral Tablet|Linagliptin 2.5 mg + Metformin 850 mg twice daily plus a lifestyle modifications program
15844322|NCT04088461|Drug|Metformin|Metformin 850 mg twice daily plus lifestyle modifications program
15844323|NCT04088448|Drug|Placebo oral tablet|Fluoxetine 20 mg capsule plus Placebo tablet administered once daily after food
15844324|NCT04088448|Drug|Metformin|Fluoxetine 20 mg capsule plus Metformin 1000 mg extended release tablet administered once daily after food
15844325|NCT04088435|Radiation|Intraoperative radiotherapy|The IORT component of this treatment is being delivered as per standard clinical practice. 20 Gy in one fraction will be delivered at the time of lumpectomy.
15844326|NCT04088422|Procedure|peripheral blood collection|peripheral blood collection at treatment start, interm PET/CT, end of treatment PET/CT, one-year and two-year follow-up and or progression or relapse
15844327|NCT04088409|Drug|Baricitinib|Administered orally
15844328|NCT04088409|Drug|Adalimumab|Administered SC
15844331|NCT04088383|Other|Amnios™ RT|Acellular human allograft
15844332|NCT04088383|Other|Saline|Sterile saline
15844333|NCT04088370|Other|Blood Draw|Blood Draw Only
15844334|NCT04088357|Drug|TolaSure Topical Gel|TolaSure topical gel is applied to skin punch biopsies daily for the first seven consecutive days, then three times a week, defined as every two to three days, until closure.
15844335|NCT04088357|Drug|Topical Vehicle Gel|TolaSure Vehicle Gel is applied topically to skin punch biopsies daily for the first seven consecutive days, then three times a week, defined as every two to three days, until closure.
15844342|NCT04088331|Device|AMS 800 Artificial Urinary Sphincter|The AMS 800 Artificial Urinary Sphincter (AUS) is an implantable, fluid filled, solid silicone elastomer device used to treat stress urinary incontinence due to reduced urethral/bladder outlet resistance (intrinsic sphincter deficiency). It is designed to restore the natural process of urinary control. The device simulates normal sphincter function by opening and closing the urethra under the control of the patient.
15844343|NCT04088318|Drug|OQL011|OQL011 is an ointment containing active ingredient.
15844344|NCT04088318|Drug|Vehicle Ointment|Vehicle ointment is an ointment containing no active ingredient.
15844345|NCT04088305|Drug|Dose|Dosage of Vancocin decided by a serum trough concentration, instead of decided by attending physician
15844346|NCT04088292|Drug|Alteplase 20 Mg Powder for Solution for Injection Vial|Low dose alteplase delivered IV or bu Ultrasound Assisted Thrombolysis device
15844347|NCT04088292|Device|Ultrasound assisted Thrombolysis|Ultrasound assisted thrombolysis (USAT)
15844348|NCT04088279|Diagnostic Test|MRI|Oxygen enhanced and fourier decomposition MRI
15844349|NCT04088266|Combination Product|16 mg buprenorphine with 4 mg naloxone sublingual film|CASSIPA®
15844350|NCT04088253|Procedure|umbilical herneal repair|reduction of the herneal content an repair of the defect with IPOM
15844351|NCT04088240|Dietary Supplement|DPA enriched n-3|4 g/d DPA enriched n-3 concentrate (~980 mg DPA, 380 mg EPA, 1720 mg DHA)
15844352|NCT04088240|Dietary Supplement|n-3 control|4 g/d n-3 control (~980 oleic acid, 380 mg EPA, 1720 mg DHA)
15844353|NCT04088240|Dietary Supplement|Placebo|"4 g/d placebo control (light olive oil)"
15844354|NCT04088227|Drug|Experimental Group|Patients will receive platelet rich plasma injection two times prior to surgery.
15844355|NCT04088227|Other|Control Group|Patients will have their knee aspirated at their initial physician visit and at the time of surgery.
15844356|NCT04088214|Procedure|Arthroscopic lateral soft tissue release|The arthroscopic lateral soft tissue release is performed using an inside-out approach via the 1MTPJ arthroscopy.
15844357|NCT04088201|Device|Glucose measurements|We will not conduct an intervention, but will obtain measurements from a continuous, non-invasive glucose sensor, and compare with those from a glucometer.
15844358|NCT04088188|Drug|Cisplatin|Given IV
15844359|NCT04088188|Drug|Gemcitabine|Given IV
15844360|NCT04088188|Drug|Ivosidenib|Given PO
15844361|NCT04088188|Drug|Pemigatinib|Given PO
15844362|NCT04088175|Other|JUUL ENDS - Virginia Tobacco 5% nicotine strength|JUUL ENDS - Virginia Tobacco 5% nicotine strength
15844363|NCT04088175|Other|JUUL ENDS - Virginia Tobacco 3% nicotine strength|JUUL ENDS - Virginia Tobacco 3% nicotine strength
15844364|NCT04088175|Other|JUUL ENDS - Menthol 5% nicotine strength|JUUL ENDS - Menthol 5% nicotine strength
15844365|NCT04088175|Other|JUUL ENDS - Menthol 3% nicotine strength|JUUL ENDS - Menthol 3% nicotine strength
15844366|NCT04088175|Other|JUUL ENDS - Mint 5% nicotine strength|JUUL ENDS - Mint 5% nicotine strength
15844367|NCT04088175|Other|JUUL ENDS - Mint 3% nicotine strength|JUUL ENDS - Mint 3% nicotine strength
15844368|NCT04088175|Other|JUUL ENDS - Mango 5% nicotine strength|JUUL ENDS - Mango 5% nicotine strength
15844369|NCT04088175|Other|JUUL ENDS - Mango 3% nicotine strength|JUUL ENDS - Mango 3% nicotine strength
15844370|NCT04088162|Device|Postoperative Negative Pressure Wound Therapy KCI NANOVA|
15844371|NCT04088149|Drug|GXNPC1|Autologous ADSCs
15844372|NCT04088136|Behavioral|Everyday Metacognitive Memory Intervention|Provides training in use of techniques and procedures to enhance proactive self-regulatory control over everyday memory demands, including strategies for learning information, planning for meeting everyday goals, and monitoring of efficacy of goal pursuit.
15844373|NCT04088136|Behavioral|Memory Strategy Control Intervention|Trains use of standard mnemonic techniques such as imagery and sentence generation for learning new associations and organizational and distinctiveness-based strategies for learning sets of items (e.g., word lists).
15844375|NCT04088110|Drug|Pyrotinib|Pyrotinib were administered 400 mg orally daily. Oral administration within 30 minutes after breakfast, and continuous administration for 21 days for 1 cycle.
15844376|NCT04088110|Drug|Trastuzumab|Trastuzumab were administered every 3 weeks intravenously (8 mg/kg loading doses followed by 6 mg/kg maintenance doses).
15844377|NCT04088110|Drug|Aromatase Inhibitors|The investigator chose an aromatase inhibitor (either anastrozole, letrozole or exemestane 1 mg/2.5 mg/25 mg), once daily, oral.
15844378|NCT04088097|Behavioral|Cognitive-Behavioral Therapy for Adolescent Binge/Loss-of-Control Eating|Cognitive-behavioral therapy (CBT) developed for adolescents with binge eating or loss-of-control eating.
15844379|NCT04088097|Other|Control Condition|Educational and informational materials on adolescent health and nutrition.
15844380|NCT04088084|Dietary Supplement|palmitoylethanolamide (PEA) 600 mg|PEA 600 mg was added to topical therapy
15844381|NCT04088071|Device|Catheter ablation|Ablation RF technologies (e.g., THERMOCOOL SMARTTOUCH®, THERMOCOOL SMARTTOUCH® SF).
15844382|NCT04088058|Drug|GXHPC1|autologous ADSCs
15844383|NCT04088045|Device|Autologous platelet rich plasma and 5% dextrose solution injections.|"One group of patients will receive autologous platelet rich plasma injection into the knee joint and pes anserinus complex. The other group will receive both PRP injections into the knee joint and pes anserinus complex, and prolotherapy of 5% dextrose solution to the genicular nerves.
~Dextrose solutions are injected to the genicular nerves."
15844384|NCT04088032|Drug|Abemaciclib, durvalumab and aromatase inhibitor|Subjects will receive standard therapy with an aromatase inhibitor (exemestane, anastrozole, or letrozole), combined with the experimental treatment of abemaciclib and durvalumab
15844408|NCT04087772|Behavioral|Mental Health Enhanced Positive Behavioral Interventions and Supports (PBIS-MH)|Mental health-enhanced Positive Behavioral Interventions and Supports (PBIS-MH) integrates mental health into the three core elements of PBIS. 1) School-based mental health clinicians are included on leadership teams. 2) Data from teacher and student perceived school climate, as well as universal screening for aggression and mental health difficulties, are used to inform intervention decision-making. 3) Evidence-based mental health prevention and intervention practices are layered into PBIS' three-tiered continuum.
15844385|NCT04088019|Drug|Fixed drug combination (FDC) of ATT and Oral steroid|"In the first two week, patients receive FDC of ATT only. Oral steroid start to be given in week three.
~The ATT regiment is continued for up to 6 months or more, in accordance with WHO guidelines. In the first two months the antibiotic combination given consisted of isoniazid (INH), rifampicin, pyrazinamide, and ethambutol. The next four months or continuation phases, the ATT given is rifampicin and isoniazid.
~The following dosage and administration of oral steroids will be given to patients, according to guidelines from the American Journal of Ophthalmologists (Douglas A. Jabs et al, 2000):
~Initial dose: 1mg/kg/day, with maximum adult oral dose 60-80 mg/kg and maintenance dose less than or equal to 10 mg/day. The tapering schedule: Over 40 mg/day, decrease by 10 mg/day every 1-2 weeks, 40-20 mg/day, decrease by 5 mg/day every 1-2 weeks, 20-10 mg/day, decrease by 2.5 mg/day every 1-2 weeks, 10-0 mg/day, decrease by 1 to 2.5 mg/day every 1-4 weeks."
15844386|NCT04088006|Device|Injection of STYLAGE® HydroMax|"STYLAGE® HydroMax is a hyaluronic acid injectable gel intended to improve skin moisturization and elasticity of the face and neckline area in this study.
~A total of 3 injection sessions will be performed one month apart for each subject.
~At each injection session, 1 mL of product will be injected in the mid to deep dermis of one cheek and another 1 mL in one site of neckline area for each subject."
15844387|NCT04087993|Drug|Polyglucoferron|intravenous administration
15844388|NCT04087993|Drug|Ferric carboxymaltose|intravenous administration
15844389|NCT04087993|Drug|Ferrous Sulfate|oral administration
15844390|NCT04087980|Device|Poseidon System|Multicenter Pilot Study of the Poseidon System for the Ablation of Prostate Tissue Utilizing Sterile Water Vapor in Patients with Intermediate Risk Localized Prostate Cancer
15844391|NCT04087967|Drug|Decitabine plus HAAG regimen|"Decitabine:20mg/m2/d,d1~5, intravenous infusion; Homoharringtonine:1mg/d,d3~16,intravenous infusion; Aclarubicin:10mg/d, d3~d10, intravenous infusion; Cytarabine:10mg/m2,q12h,d3-16, subcutaneous injection;
~Granulocyte colony-stimulating factor (G-CSF):
~50-300μg/d (when WBC counts are less than 20×10^9/L ),subcutaneous injection;"
15844392|NCT04087967|Drug|Idarubicine plus Cytarabine regimen|Idarubicine :12mg/m2, d1-3, intravenous infusion; Cytarabine :100mg/m2, d1-7, 24-hours continuous intravenous infusion
15844393|NCT04087954|Behavioral|Stigma reduction program|"Participants in the intervention group received treatment as usual, supported with stigma reduction program booklets each fortnight for 26 weeks. The stigma reduction program includes three modules; psychoeducation, cognitive behavioural therapy and social skills training. The program aims to enhance patient understanding of Schizophrenia and foster communication skills which supposed to increase self-confidence and strengthen communication networking with society.
~Psychoeducation module purposes at introducing about the concepts of schizophrenia, providing patient with essential information about schizophrenia, including nature of disease, sign/symptoms, treatment strategies, side effects of medication. Social Skills Training (SST) module purposes at fostering communication skills among patient diagnosed with schizophrenia. This assists the participants to be re-integrated in the society and build a harmonious atmosphere in the community."
15844394|NCT04087941|Biological|VM-202|VM202 is a DNA plasmid that contains novel genomic cDNA hybrid human hepatocyte growth factor (HGF) coding sequence (HGF-X7) expressing two isoforms of HGF, HGF 728 and HGF 723.
15844395|NCT04087928|Device|FMV_flex|Fisiocomputer EVM (Endomedica, Italy) for application of FMV to flexor muscles of the upper limb (brachial biceps and carpal flexors).
15844396|NCT04087928|Device|FMV_ext|Fisiocomputer EVM (Endomedica, Italy) for application of FMV to extensors muscles of the upper limb (triceps brachial and carpus extensors).
15844397|NCT04087915|Drug|Evolocumab|Participants received evolocumab 140 mg Q2W or 420 mg QM subcutaneous injections according to their own preference
15844398|NCT04087889|Biological|HB-adMSCs|Culture-expanded, adipose-derived mesenchymal stem cells donated by first blood relative
15844399|NCT04087876|Drug|derazantinib|derazantinib will be administered orally
15844400|NCT04087863|Other|Not applicable(observational study)|Not applicable(observational study)
15844401|NCT04087850|Behavioral|Making Socially Accepting Inclusive Classrooms|Using a consultation model, study staff members met with teachers approximately twice per month and observed them an additional two times per month. The goal was to help teachers implement practices that create a socially accepting classroom climate for children.
15844402|NCT04087837|Device|bougie|The endotracheal tube is used in the bougie mode under the direct view of the electronic imaging laryngoscope.
15844403|NCT04087837|Device|Nasogastric(NG) tube|The endotracheal tube is used in the NG tube mode under the direct view of the electronic imaging laryngoscope.
15844404|NCT04087824|Device|AI assisted recognition of colonic segments|After receiving standard bowel preparation regimen, patients go through colonoscopy under the AI monitoring device. The whole withdrawal process is monitored by AI associated recognition system. Key colonic segments include ileocecal valve, ascending colon, transverse colon, descending colon, sigmoid colon and rectum. When typical anatomic sites are detected, the AI device will automatically captured relevant images and report the name of each segment on the screen. The operating endoscopy expert will give the final answer and judge the performance of AI, which is set as a golden standard. Then all the AI captured images will be reviewed by human group, which consists of three to five experienced endoscopic physicians.
15844405|NCT04087811|Device|Superion® Indirect Decompression System (IDS)|Superion® Indirect Decompression System (IDS) (Superion® implant)
15844406|NCT04087798|Behavioral|Control-EDI|Patients in the control group will receive Control-EDI from their primary care provider during clinic visit. Subsequent patient CKD education and follow-up will be provider dependent. Patients will be called and reminded of their study visits at 1, 6, 12 months to complete study measures, BP checks, and give urine and blood samples (baseline and 12-month visit only).
15844407|NCT04087798|Behavioral|Intervention-EDI and health coaching|"Patients in the intervention group will receive a personalized Intervention-EDI from their primary care provider during visit, which will include their most recent BP, their urine protein level and most recent eGFR. There is also a space for their provider to type in a sentence about specific goals for the patient.
~Health coaches will conduct a baseline call and 4-6 coaching calls, based on patient's needs, over an 11-month period. There are 4 topic areas related to blood pressure and CKD that will be the focus of the calls. Coaches will also have pre-determined and vetted educational resources to provide patients if needed. Additionally, patients will be called and reminded of their study visits at 1, 6, 12 months to complete study measures, BP checks, and give urine and blood samples (baseline and 12-month visit only)."
15844409|NCT04087772|Behavioral|Racial/Ethnic Discrimination Interventions (RED)|Racial/Ethnic Discrimination Interventions are a set of components to address multiple forms of school-based racial and ethnic discrimination. 1) Unintentional bias training for school personnel, involving teaching participants to conceptualize prejudice as well as strategies to reduce bias. 2) Unintentional bias training for students that is delivered in a classroom in a developmentally appropriate lesson format. 3) Vulnerable Decision Point process: Leadership teams are trained to reduce disparities in school discipline by a) using disaggregated student discipline data to identify particular settings or practices that are drivers for racial/ethnic disproportionality in a school and b) using iterative problem-solving to address these drivers. 4) Teacher stress reduction training where they are provided with strategies to reduce stress.
15844410|NCT04087759|Drug|Bedaquiline (Test formulation)|Participants will receive bedaquiline orally.
15844411|NCT04087759|Drug|Bedaquiline (Reference formulation)|Participants will receive bedaquiline orally.
15844412|NCT04087746|Drug|Aflibercept|Intra-vitreal injection of AVEGF AFLIBERCEPT in group I
15844413|NCT04087746|Drug|Ranibizumab|Intra-vitreal injection of AVEGF Ranibizumab in group 2
15844414|NCT04087733|Drug|OZODROP|3 days before the cataract surgery (T0), two conjunctival swabs will be taken from the patients enrolled in the study, one in the eye to be operated and one in the control eye, who will be kept at a controlled temperature (+ 2 / + 7 ° C) and sent to the laboratory within 24 hours. Than, starting on the day of collection, the patients will instill the OZODROP® eye drops in the eye to be used (2 drops 4 times a day, 1 drop every 4 hours: 9:00 am, 1:00 pm, 5:00 pm: 00, h21: 00), while the contralateral eye will be treated with a saline solution and it will serve as a control. Immediately before the cataract surgery (T3), the patients enrolled in the study will again receive two conjunctival swabs, one in the eye to be operated and one in the control eye. The last OZODROP® instillation will be carried out 10 minutes before the withdrawal. For the microbiological evaluation, the conjunctival swabs taken at T0 and T3 will be sent to the Microbiology laboratory
15844415|NCT04087720|Biological|Pegloticase|Participants will receive 8 mg pegloticase by IV infusion every 2 weeks from Day 1 through Week 22
15844416|NCT04087707|Drug|Step 1: TS-142|Non-elderly participants will receive 20 mg of TS-142 once daily for 7 consective days
15844417|NCT04087707|Drug|Step 2: TS-142|Elderly participants will receive 20 mg of TS-142 once daily for 7 consective days
15844418|NCT04087707|Drug|Step 2: Placebo|Elderly participants will receive placebo once daily for 7 consective days
15844419|NCT04087694|Procedure|Microdecompression|comparative surgical treatment
15844420|NCT04087668|Procedure|Monitored Anesthesia Care|MAC was induced and maintained via the continuous infusion of propofol AND remifentanil using a target-controlled infusion (TCI) pump. The appropriate level of sedation was 65 to 80 points on BIS. The adjunctive sedatives (eg, fentanyl, midazolam) was at the discretion of the anesthesia team.
15844421|NCT04087668|Procedure|General Anesthesia|Induction was done with propofol (2 mg/kg) , cis-atracurium (0.15 mg/kg) , and fentanyl (5μg/kg). After orotracheal intubation, general anesthesia was maintained with sevoflurane (1-1.3MAC) , propofol (3mg/kg/h), remifentanil (0.05-0.2 ug/kg/min) and repetitive doses of 0.1mg atracurium per kilogram were administered. After the procedure was completed, neostigmine mixed with atropine was used as a reversal agent for the neuromuscular blockade, and the patient was extubated when the recovery from anesthesia was confirmed.The BIS was 45 to 60 points .
15844422|NCT04087668|Procedure|Induction Without Neuromuscular Blockade|Anaesthesia was induced with propofol (2 mg/kg), remifentanil(3 ug/kg) and 2% lidocaine (1 mg/kg). Nasotracheal intubation was performed 60 s after the administration. After intubation, general anesthesia was sevoflurane (1-1.3MAC) , propofol (3mg/kg/h), remifentanil (0.05-0.2 ug/kg/min). After the procedure was completed, the patient was extubated when the recovery from anesthesia was confirmed.The BIS was 45 to 60 points .
15844423|NCT04087655|Behavioral|Exercise|Eight weeks of interval exercise training
15844424|NCT04087642|Diagnostic Test|Intraoperative Crede manoeuver|In this group, both tests will be performed but the intraoperative Crede manoeuver will determine if a mid-urethral sling is placed concomitantly. If the test is positive, a sling will be placed. If the test is negative, no sling will be placed.
15844425|NCT04087642|Diagnostic Test|Preoperative prolapse reduction cough stress test|In this group, both tests will be performed but the preoperative prolapse reduction cough stress test will determine if a mid-urethral sling is placed concomitantly. If the test is positive, a sling will be placed. If the test is negative, no sling will be placed.
15844426|NCT04087629|Device|StrataCTX® gel|Gel forming flexible wound dressing for the prevention and treatment of radiation dermatitis
15844427|NCT04087616|Behavioral|ICBIT|The intervention consists of 9 modules delivered over 9 weeks comprise of age-appropriate texts and descriptive diagrams, animations, films of clinicians demonstrating techniques such as competing response exercising.
15844428|NCT04087616|Behavioral|waiting list|Participants initially assigned to the wait list received no psychosocial intervention for 9 weeks. Following post-WL assessment, all participants chose to receive ICBIT.
15844429|NCT04087603|Behavioral|Weekend Morning Bright Light & Early Bedtime|
15844430|NCT04087590|Drug|Formoterol-glycopyrronium co suspension (PT003)|Formoterol-glycopyrronium co suspension (PT003) in a Metered Dose Inhaler, 2 puffs twice daily
15844431|NCT04087577|Other|conventional physical therapy|includes electrical stimulation for denervated muscles, and soft tissue massage, joint range of motion exercises to maintain the flexibility of the affected joint, muscle or connected tissues, sensory relearning
15844432|NCT04087577|Other|mirror therapy|mirror therapy
15844433|NCT04087564|Other|music intervention|"The music intervention (Unwind), developed by the investigators collaborators at the Sync Project, is a machine learning protocol that generates specific sounds and phrases of music that are stitched into a music track in response to user-reported pain, anxiety and catastrophizing scales. Unwind is delivered via a web application on a smart phone.
~Participants will also listen to white noise and their favorite music throughout the study session"
15844434|NCT04087551|Other|Developing the list of items for BRFES|The finalized list of items will be discussed by two researchers who will combine similar items generated by the two focus groups to complete the Balance Recovery Falls-Efficacy Scale. The list of items has been developed by a group of community-dwelling older adults who had demonstrated an understanding of near-falls and will be able to articulate the use of balance recovery strategies used in near-fall experiences.
15844545|NCT04086602|Drug|IZD334|Active Drug
15844435|NCT04087538|Diagnostic Test|Troponin T and I|Does the use of troponin T or I increase the number of patients referred to coronary angiography
15844436|NCT04087525|Drug|HIP1701|Vildagliptin
15844437|NCT04087525|Drug|HGP1809|Vildagliptin
15844438|NCT04087512|Other|Training on perturbation treadmill|Perturbations into different directions are induced during static and dynamic tasks on a treadmill. Perturbations include announced and unannounced perturbations. Intensity and number of perturbations increases over the course of the intervention based on judgement of participant. Intervention duration: 6 weeks, 3 sessions a week, each session approx. 30 minutes.
15844439|NCT04087512|Other|Exercises of dynamic stability under unstable conditions|The mechanisms of dynamic stability recovery are trained under unstable conditions. Different unstable undergrounds are used to stand on, perform lunges or jumps. Additionally, balance is challenged by different restrictions (e.g. decreased base of support, closed eyes) or therapist-applied perturbations. Intervention duration: 6 weeks, 3 sessions a week, each session approx. 45 minutes.
15844440|NCT04087499|Device|Acupuncture|acupuncture treatment on selected acupoint
15844441|NCT04087486|Diagnostic Test|Implementation of a behavioural test for patients with TBI|"The following data will be collected: (1) sociodemographic variables (2); clinical and psychological data; (3) functional tests (neuropsychological testing, TEM version CRR and TEM-PRO).
~On day one, patients will undergo standard neuropsychological tests and questionnaires listed hereafter, which are commonly used in the clinical practice at the CRR.
~The Patient Competency Rating Scale (PCRS)
~TEM (Multiple errands test)
~GREFEX
~5 POINTS TEST
~TAP 2.3
~Behavioral Assessment of the Dysexecutives Syndrome (BADS)
~On day two, the patients will perform the TEM-PRO test ambulatory in our vocation rehabilitation unit.
~Predictors variables will be collected before testing: Sociodemographic: age, sex, education, marital status, mother language, time since TBI, severity of the TBI (moderate or severe), type of lesion (contusion, diffuse axonal injury grade 1-3, ischemic or other complications), history of TBI, stroke or meningitis."
15844442|NCT04087460|Biological|Protein based pneumococcal vaccine(Low dose)|0.2mL,Intramuscular other name:PBPV
15844443|NCT04087460|Biological|Protein based pneumococcal vaccine placebo(Low dose)|0.2mL,Intramuscular other name:PBPV placebo
15844444|NCT04087460|Biological|Protein based pneumococcal vaccine(Middle dose)|0.5mL,Intramuscular other name:PBPV
15844445|NCT04087460|Biological|Protein based pneumococcal vaccine placebo(Middle dose)|0.5mL,Intramuscular other name:PBPV placebo
15844446|NCT04087460|Biological|Protein based pneumococcal vaccine(High dose)|1.0mL,Intramuscular other name:PBPV
15844447|NCT04087460|Biological|Protein based pneumococcal vaccine placebo(High dose)|1.0mL,Intramuscular other name:PBPV placebo
15844448|NCT04087447|Procedure|Thyroidectomy|Thyroidectomy
15844449|NCT04087434|Device|Brain Gauge Prospective and Healthy Control|The Brain Gauge is a brain health assessment system that takes advantage of the well-documented relationship between the sensory nerves in the fingers and the projection of those nerves to corresponding regions in the brain. The system is composed of a test device (the Brain Gauge) that uses novel fingertip vibration patterns to probe cortical complexity and utilize that complexity to gain more sensitive and specific detection of compromised neural function.
15844450|NCT04087421|Device|Qufora Irrisedo Cone System|The system works by connecting a tube from a water bag to a cone. The cone is placed into the rectum and the prescribed water volume is pumped into the rectum. When the water has been installed the valve is closed and the cone removed. Residual water and stool will then flow into the toilet.
15844451|NCT04087421|Drug|"Glycerol OBA"|Rectal suppository. Stimulates the rectum and softens and loosens stool.
15844452|NCT04087408|Drug|Effect of adding gonadotropins releasing hormone agonist to progesterone for luteal phase support in assisted reproductive technique )antagonist cycles(: a randomized controlled trial|"Ovarian stimulation will be initiated from the day 2 of the menstrual cycle using gonadotropins 150-450 IU
~doses will be adjusted according to ovarian response. Once the leading follicle will reach a size of 14 mm, co-treatment with a GnRH antagonist will initiated and continued up until at least three follicles reached a size of 17-18 mm.
~Trigger will be done using HCG followed by OPU 36 h later.
~Retrieved oocytes will be fertilized by ICSI.
~LPS, using micronized P (400 mg/day) vaginally beginning on the day of oocyte retrieval.
~GnRH agonist 0.1 mg will be given 6 days after OPU for the study group.
~Blood sampling will be performed for progesterone within 24 h following the GnRH agonist 0.1 mg
~Quantative BHCG will be performed 14 days after OPU."
15844453|NCT04087395|Device|RHA®4 with new anesthetic agent|A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 23 mg/g and 0.3% w/w of new anesthetic agent in a physiologic buffer.
15844454|NCT04087395|Device|RHA®4-Lidocaine|A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 23 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
15844455|NCT04087382|Device|thrombectomy|Transfemoral a microcatheter with its distal end was positioned a few millimeters beyond the distal aspect of the clot, the guide wire was exchanged by Solitaire stent device. The device was held in place when 3 mm was out of the microcatheter. The microcatheter was slowly pulled back to deploy the TR or ST device over the clot.
15844456|NCT04087382|Other|non intervention group|medical treatment (Asprin, statin, nootropic drug)
15844457|NCT04087369|Other|Bundled NCD WHO PEN Intervention|In the intervention includes the planned roll-out of the World Health Organization's Package of essential noncommunicable disease interventions (WHO PEN) for primary care in low resource settings by the Government of Nepal, Ministry of Health and Population. In addition, this intervention will include three evidence-based components: 1) non-communicable disease (NCD) care integration using mid-level practitioners (MLPs) and community healthcare workers (CHWs); 2) clinical decision support (CDS) tools to ensure quality care in accordance with best practices; and 3) training and supervision of MLPs to provide motivational interviewing (MI) techniques for modifiable risk factor optimization, with a specific focus on tobacco and alcohol use.
15844458|NCT04087356|Genetic|Blood draw|Blood samples are collected for genetic analysis, looking specifically at serum lipids and the inflammatory biomarker hs-CRP.
15844546|NCT04086602|Drug|Placebos|Placebo to Match
15844547|NCT04086589|Other|Observational study without intervention|Observational study without intervention
15844459|NCT04087343|Behavioral|Meals plus exercise|Patients will receive 12 weeks of meals on wheels meal delivery consisting of 3 meals per day during the weekdays with 6 frozen meals to cover the weekends.They will also receive an exercise kit on the first visit by the meal delivery driver with 2 tennis balls,2 1-pound hand weights, and one towel.Every week,the driver will give them 3 exercises from the National Institute on Aging's Go4Life Workout-to-Go book,1 exercise from each of 3 categories:strength/endurance, balance, and flexibility. They will be asked to do the 3 exercises every day.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
15844460|NCT04087343|Behavioral|Meals only|Patients will receive 12 weeks of an enhanced meals on wheels (MOW) in-person meal delivery consisting of 3 meals per day (1 shelf-stable, 1 hot, and 1 frozen) during the weekdays (Monday through Friday) with 6 frozen meals at the end of the week to cover the weekends.The meal delivery drivers will ask daily questions about physical activity and any potential injuries and the participants will be asked to track their own weekly exercise and physical activity as well as their monthly progress on a standardized log. All participants will also be asked to wear a fitness activity tracker which will monitor heart rate, activity level, and sleep habits for the duration of the study.
15844461|NCT04087330|Other|Group 1 Experimental group|"Stretching exercises for Achilles tendon, hamstrings, hip flexors and adductors of lower limbs, upper abdominal and pectoralis muscles.
~Facilitation of postural reactions, including: facilitation of righting, equilibrium and protective reactions from sitting on ball.
~Facilitation of standing and weight shift. Facilitation of standing balance by tilting the child from standing to different directions (forward, back-ward and side-way) using a balance board.
~Gait training: by forward, backward, and side-way walking between parallel bars.
~Whole body vibration."
15844462|NCT04087330|Other|Group 2 Control group|"Stretching exercises for Achilles tendon, hamstrings, hip flexors and adductors of lower limbs, upper abdominal and pectoralis muscles.
~Facilitation of postural reactions, including: facilitation of righting, equilibrium and protective reactions from sitting on ball.
~Facilitation of standing and weight shift. Facilitation of standing balance by tilting the child from standing to different directions (forward, back-ward and side-way) using a balance board.
~Gait training: by forward, backward, and side-way walking between parallel bars."
15844463|NCT04087317|Drug|Paracetamol 500 Mg Oral Tablet|The drug will be administrated when the woman arrive to the maternity unit, and every 6 hours thereafter, for first 24 hours following delivery.
15844464|NCT04087317|Drug|Ibuprofen 400Mg Tab|The drug will be administrated when the woman arrive to the maternity unit, and every 6 hours thereafter, for first 24 hours following delivery.
15844465|NCT04087317|Drug|Paracetamol 500 Mg Oral Tablet|The drug will be administrated after a maternal request, by at least 6 hours apart between dosages.
15844466|NCT04087317|Drug|Ibuprofen 400 mg|The drug will be administrated after a maternal request, by at least 6 hours apart between dosages.
15844467|NCT04087304|Behavioral|Risk Status Optimization|Assessment of risk factors putting surgical candidates of total hip and knee arthroplasty at higher risk of complication, and promoting risk factor optimization, thereby decreasing associated risk.
15844468|NCT04087291|Other|Chiropractic Care|"Chiropractic interventions:
~Patient education.
~Passive interventions, such as spinal manipulation and myofascial therapies which include thrust type (high velocity-low amplitude) spinal manipulation for the low back, non-thrust manipulation (joint mobilization), and use of manually held instruments, such as an Activator. Myofascial therapies are also commonly used, such as myofascial release and trigger point therapy.
~Transitional interventions, such as therapeutic exercise.
~Recommendations for active interventions, such as general exercise and mind-body therapies.
~Self-management advice, which refers to advice given to build the capacity of a person to self-monitor, control, and/or reduce the impact of a condition over time."
15844471|NCT04087265|Diagnostic Test|Transabdominal ultrasound|Transabdominal ultrasound will be performed 30 minutes before colonoscopy
15844472|NCT04087252|Biological|tumor neoantigen|tumor neoantigens
15844473|NCT04087239|Other|HIV|
15844474|NCT04087226|Device|PTFE Retraction Cord|Polytetrafluoroethylene (PTFE) Retraction cord will be gently applied in gingival sulcus with minimal pressure. The intervention will be applied for three minutes in gingival sulcus, followed by a two stage addition silicone impression.
15844475|NCT04087213|Device|HemoCare™ Hemodialysis System|The HemoCare™ Hemodialysis System is intended for hemodialysis treatment, including short daily and nocturnal hemodialysis, of renal failure patients. The HemoCare™ Hemodialysis System is intended for use in chronic dialysis facilities, self-care dialysis facilities, or the home setting. All treatments must be prescribed by a physician and administered by a trained operator. Treatments must be performed under the supervision or assistance of a medical professional or a care partner who has been trained and deemed competent in the use of the device by the prescribing physician.
15844476|NCT04087187|Drug|Treatment A|Subject will be given AZD5718 Dose A tablet once daily
15844477|NCT04087187|Drug|Treatment B|Subjects will be given AZD5718 Dose B tablet once daily
15844478|NCT04087187|Drug|Treatment C|Subjects will be given AZD5718 Dose C tablet once daily
15844479|NCT04087174|Drug|Capivasertib|Patients will receive multiple oral dose of capivasertib.
15844480|NCT04087174|Drug|Enzalutamide|Patients will receive 160 mg oral dose of enzalutamide.
15844481|NCT04087174|Drug|Abiraterone|Patients will receive 1000 mg oral dose of abiraterone.
15844482|NCT04087161|Other|Nephrocheck bed side testing of AKI|Usage of Nephrocheck system to assess AKI after open TAAA repair
15844483|NCT04087135|Other|direct laryngoscopy|Participants will intubate the hemoptysis cadaver model in simulation with direct laryngoscopy MacIntosh blade.
15844484|NCT04087135|Other|videolaryngoscopy McGrath|Participants will intubate the hemoptysis cadaver model in simulation with videolaryngoscopy using McGrath and the short curved blade (XBlade)
15844548|NCT04086576|Device|Alcohoot|Alcohoot branded smartphone-paired breathalyzer
15844485|NCT04087135|Other|videolaryngoscopy McGrath with suction|Participants will intubate the hemoptysis cadaver model in simulation with videolaryngoscopy using McGrath and the short curved blade (XBlade) and a suction they will advanced directly before the optic of the camera.
15844486|NCT04087122|Device|Esophageal warming device (Attune Medical, Chicago, IL|Prospective, single center pilot stud
15844487|NCT04087109|Other|Electronic decision support for deprescribing (MedSafer tool)|During the intervention phase, MedSafer will provide users with individualized and prioritized deprescribing opportunities: a) identifying the medication, b) explaining why that medication is potentially inappropriate and c) providing instructions on how to safely stop/taper the medication. The user will review these opportunities and appropriate candidate medications for deprescribing can then be tapered or stopped directly in the EMR. Patients or proxy will also receive educational medications brochures (EMPOWER) from the research assistant or staff at the nursing home, as applicable to the medications they are taking (PPI, sedative-hypnotic, antipsychotic, antihistamine, sulfonylurea, NSAID, opioid/narcotic).
15844488|NCT04087096|Drug|Denosumab|Denosumab will be administered at postoperative months 1, 7, and 13
15844489|NCT04087096|Drug|Placebo|Placebo will be administered at postoperative months 1, 7, and 13
15844490|NCT04087096|Drug|Zoledronic Acid|Zoledronic Acid 5mg will be administered intravenously at postoperative month 19
15844491|NCT04087083|Other|Technological intervention arm|Each session will include 30 minutes of traditional physical rehabilitation therapy followed by 20 minutes of robotic training (G-EO system, Reha Technology, Switzerland), an end-effector technology that simulates floor walking and stairs climbing (up and down)
15844492|NCT04087083|Other|Control arm|Each session will include 50 minutes of traditional physical rehabilitation therapy
15844493|NCT04087070|Device|Biosignal measurements|"Following parameters will be measured by non-invasive electrocardiogram (ECG), photoplethysmograph (PPG), and an accelerometer on the chest and will be used to estimate the biosignal derived blood pressure.
~PAT(time between R peak of ECG and beginning of the pulse of PPG)
~PEP(time between R peak of ECG and peak of accelerometer signal)
~PTT(PAT-PEP)"
15844494|NCT04087057|Other|Interview|Participate in interview
15844495|NCT04087057|Other|Medical Chart Review|Patients' medical records are reviewed
15844496|NCT04087057|Behavioral|Questionnaire|Complete questionnaires
15844497|NCT04087044|Device|Computerized Rotational Head Impulse Test ( crHIT)-Vertical|"Oculo-Motility and Positional Testing,
~Caloric Testing"
15844498|NCT04087031|Other|control arm|Each session will include 50 minutes of traditional physical rehabilitation therapy
15844499|NCT04087031|Other|virtual reality games|Each session will include 30 minutes of traditional physical rehabilitation therapy followed by 20 minutes of robotic Tymo system (Tyromotion, Austria), a wireless static and dynamic platform, for evaluating and rehabilitating posture.
15844500|NCT04087031|Other|robotic treadmill|Each session will include 30 minutes of traditional physical rehabilitation therapy followed by 20 minutes of robotic Walker View (TecnoBody, Italy) a treadmill equipped with a sensorized belt with eight load cells and a 3D camera
15844502|NCT04087005|Other|hominis placental pharmacopuncture|Hominis placental pharmacopuncture is human placental extract, which has been used in traditional Korean medicine to treat chronic diseases, including frailty, cough, anorexia, and fatigue, by enhancing the body's resistance.
15844503|NCT04086992|Other|Remote monitoring|Caregivers will be able to monitor blood pressure from home and upload in a cloud-based application on a hand-held tablet. In addition, this technology will administer surveys to the caregiver to assess for therapy side effects and adherence. Nurse-led telemedicine visits will also be utilized. The healthcare team will be able to monitor these parameters remotely.
15844504|NCT04086979|Behavioral|Parental Friendship Coaching|In this condition, therapists instructed parents in ways to coach their children to display better friendship behaviors using skills teaching, role play, active practice, and homework. This is a 10 week group intervention.
15844505|NCT04086979|Behavioral|Coping with ADHD through Relationships and Education|In this condition, the therapist provided parents with psychoeducation about ADHD and friendship difficulties, and encouraged them to apply this information to their child and to support one another with tips about how to address these problems. This is a 10 week group intervention.
15844507|NCT04086953|Diagnostic Test|6-minute walk test|This test is carried out in a 30-meter long walking corridor with two cones placed at the ends of the course and representing the turning zones
15844508|NCT04086953|Diagnostic Test|Walk-Time Limit Tes|Endurance test where the patient must walk at the same speed during the whole test (time limit). The test is carried out in a corridor 10 meter long.
15844509|NCT04086953|Diagnostic Test|Incremental shuttle walk test|Incremental walking test suitable for patients with chronic respiratory diseases. To perform this test, it is necessary to have a 10-meter walking corridor. The walking speed is dictated by a sound signal previously recorded. Every minute, the time between each beep is decreased and therefore the walking speed increased. The increment is 0.17m / sec every minute. Shifting to a higher speed is indicated by a triple beep. At most, the ISWT includes 12 speed levels.
15844510|NCT04086953|Diagnostic Test|Endurance shuttle walk test|"Constant load endurance running test performed on the same 10 meter run as the ISWT.
~The patient is walking at a constant speed imposed by the audio beeps as for the ISWT. The objective of this test is to maintain the imposed walking speed as long as possible. The speed is calculated from the ISWT."
15844511|NCT04086953|Diagnostic Test|Respiratory Functional Assessment|Forced vital capacity, total lung capacity, forced expiratory volume measured during the first second of forced expiration, and carbon monoxide diffusion capacity will be measured by plethysmographic examination and spirometry.
15844512|NCT04086940|Drug|Esmolol|preventive
15844513|NCT04086927|Device|Unna Boot|The unna boot is a zinc coated compression dressing
15844514|NCT04086914|Procedure|Nerve Block|This group will receive a nerve block consisting of 20mL of 5mg/mL ropivicanine and 0.1mL of 10mg'mL dexamethasone.
15844549|NCT04086576|Device|BACtrack Mobile Pro|BACtrack Mobile Pro branded smartphone-paired breathalyzer
15844515|NCT04086901|Radiation|Radiotherapy dose escalation|Flour-Deoxy-Glucose /Positron Emissions Tomografi (FDG-PET) scans will be used to identify and delineate the tumour sub-volumes with the highest tracer uptake to guide the dose-escalation. The dose to the Gross tumor volume (GTV) will be escalated to a high dose while clinical target volume (CTV) and planning target volume (PTV) will be treated with standard dose.
15844516|NCT04086875|Behavioral|Focus Group|Participate in focus group
15844517|NCT04086875|Other|Text Message|Receive text messages
15844518|NCT04086875|Other|Best Practice|Receive usual care
15844519|NCT04086875|Other|Questionnaire Administration|Ancillary studies
15844520|NCT04086862|Procedure|Therapeutic ultrasound|A commercially available ultrasound machine will provide 5 minutes of ultrasound at 0.4 watt/cm^2 and 100% duty cycle sequentially to each masseter muscle.
15844521|NCT04086849|Diagnostic Test|Radiomic, pathomic, and clinical markers|This is a non-interventional study.
15844522|NCT04086836|Device|TAVR|Patient recieving a TAVR
15844523|NCT04086823|Drug|RZL-012|Subcutaneous injection to the submental fat area
15844524|NCT04086823|Drug|Placebo|Placebo
15844525|NCT04086810|Drug|DCCR|Once daily oral administration
15844526|NCT04086797|Dietary Supplement|IQP-AE-103|1980 mg
15844527|NCT04086797|Dietary Supplement|Placebo|Placebo
15844528|NCT04086771|Behavioral|Navigation|Weekly phone-calls, personal messages, and American Cancer Society Pap test and mammography test reminder post card
15844529|NCT04086771|Other|Information only|American Cancer Society breast and cervical cancer screening information and Pap test and mammography test reminder post card
15844530|NCT04086758|Drug|zolbetuximab|Zolbetuximab will be administered as a 2-hour intravenous infusion
15844533|NCT04086732|Procedure|High-frequency electrical stimulation|High-frequency stimulation will be applied on the volar forearm (6-10 cm distal to the cubital fossa). To avoid any confounding effect of handedness, the arm onto which HFS will be applied twice (dominant vs nondominant) will be counterbalanced across participants. HFS will consist of 12 trains of 42 Hz electrical pulses lasting 1 s each. The time interval between each train will be 10 s. The intensity of stimulation will be milliampere. Electrical pulses will be delivered to the skin using a specifically-designed electrode designed: the cathode consists of 16 blunt stainless-steel pins with a diameter of 0.2 mm protruding 1 mm from the base. The 16 pins are placed in a circle with a diameter of 10 mm. The anode consists of a surrounding stainless-steel ring having an inner diameter of 22 mm and an outer diameter of 40 mm. This procedure induces secondary pinprick hyperalgesia (an increase in pinprick sensitivity in a large area of the skin).
15844534|NCT04086719|Drug|BMS-986165|Oral administration of tablet BMS- 986165
15844535|NCT04086719|Drug|Pyrimethamine|Oral administration of Pyrimethamine in combination with BMS-986185
15844536|NCT04086706|Procedure|Retroflexion in the Right Colon|Prospective evaluation of an every day technique (retroflexion) used in our department for many years. The protocol of ascending colon examination encompassed 2 phases: A first phase (1) divided in Forward view (1a) videlicet insertion from the right flexure to the caecum followed by a second forward view (1b) namely withdrawal till the right flexure and reinsertion to the caecum maintaining the endoscope straight and a second phase (2, Retroflexion) with U-turn of the colonoscope in the caecum till the right flexure and then redressing to the forward view and reinsertion to the caecum.
15844537|NCT04086693|Device|Standard IV dressing|Polyurethane and clear tape dressing used to secure peripheral IV
15844538|NCT04086693|Device|Standard IV dressing plus a tissue adhesive peripheral IV securement device|Polyurethane dressing with clear tape plus a tissue adhesive peripheral IV securement device used to secure peripheral IV
15844539|NCT04086667|Other|Spinal manipulation|Spinal manipulation: The patient is placed in the side-position and a standard manipulation lumbar-roll technique will be applied at the indicated segment dependent on the subgroup indication.
15844540|NCT04086654|Diagnostic Test|International Trauma Interview (ITI) for ICD-11 PTSD and Complex PTSD - German version|The ITI consists of 18 items and for each symptom, standardized questions as well as probes are presented. A trained professional rates both symptom frequency and intensity, which are converted into an overall index of symptom severity. A diagnosis of PTSD/CPTSD is established by applying the ICD-11 diagnostic rules. It takes approximately 30-60 minutes to administer.
15844541|NCT04086641|Device|Crossover foot|A prosthetic foot that features an extended strut (keel) that attaches to the posterior proximal aspect of the prosthetic socket.
15844542|NCT04086641|Device|Energy Storing Foot|A prosthetic foot that features a short strut (keel) that attaches to the distal aspect of the prosthetic socket.
15844543|NCT04086615|Device|NMES and exercise supplemented with high BFR|"The BFR-NMES-Exercise training consists of 20-min sessions performed concurrently with NMES and exercise in the clinic 2x a week for a total of 18 in-clinic sessions. Using the Delfi PTS Personalized Tourniquet System for Blood Flow Restriction at 80% of LOP, the participant performs 4 exercise sets of 60 repetitions (5 seconds ea) for 5 minutes, with a 1-minute BFR deflation between sets. The standard exercise rehabilitation protocol for PFPS combines open chain and closed chain quadriceps strengthening exercises: active straight leg raises, quadriceps straightening, step up, and squats. NMES training consists of 20-minute sessions: a 2-min warm-up, 15-min work-out, and a 3-min cool down using the KneeHAB® XP Multipath stimulation system which changes the current pathways between the electrodes for preset periods within each pulse, allowing for higher stimulation intensities that maximizes muscle fibre recruitment and minimizes muscle fatigue."
15844544|NCT04086615|Device|NMES and exercise supplemented with low BFR|"The BFR-NMES-Exercise training consists of 20-min sessions performed concurrently with NMES and exercise in the clinic 2x a week for a total of 18 in-clinic sessions. Using the Delfi PTS Personalized Tourniquet System for Blood Flow Restriction at 20mmHG venous pressure (no blood flow restricted), the participant performs 4 exercise sets of 60 repetitions (5 seconds ea) for 5 minutes, with a 1-minute BFR deflation between sets. The standard exercise rehabilitation protocol for PFPS combines open chain and closed chain quadriceps strengthening exercises: active straight leg raises, quadriceps straightening, step up, and squats. NMES training consists of 20-minute sessions: a 2-min warm-up, 15-min work-out, and a 3-min cool down using the KneeHAB® XP Multipath stimulation system which changes the current pathways between the electrodes for preset periods within each pulse, allowing for higher stimulation intensities that maximizes muscle fibre recruitment and minimizes muscle fatigue."
15844553|NCT04086576|Device|Floome|Floome branded smartphone-paired breathalyzer
15844554|NCT04086576|Device|Intoxilyzer 240|Intoxilyzer 240 police grade breathalyzer
15844555|NCT04086563|Other|Action observation|look at a clip of a hand doing neurodynamic exercises.
15844556|NCT04086563|Other|Mirror therapy|With a mirror glasses on, do the neurodynamic exercises with the non-dominant hand while the patient is looking at the dominant hand
15844557|NCT04086563|Other|Neurodynamic exercises|active movement of the dominant hand. Do neurodynamic exercises.
15844558|NCT04086563|Other|Strength|Execute a short strength training for the dominant hand
15844559|NCT04086550|Device|LIQOSEAL|Adjunctive bioresorbable patch
15844560|NCT04086550|Device|DuraSeal, Adherus|synthetic absorbable sealants
15844561|NCT04086537|Diagnostic Test|hepcidin levels and BMPR2 expression|Samples will be collected in the three groups. Hepcidin levels will be measured in serum using ELISA and BMPR2 expression will be assessed as previously described using real time-qPCR
15844562|NCT04086524|Other|Binocular cartoon treatment at home|see arm description.
15844563|NCT04086524|Other|Patching|see arm description
15844564|NCT04086524|Other|Binocular cartoon treatment in office|see arm description.
15844565|NCT04086498|Other|Mediterranean diet|The group received a plan for a isocaloric Mediterranean Diet
15844566|NCT04086498|Other|KEMEPHY|The group received a plan for a ketogenic mediterranean with herbal extracts diet
15844567|NCT04086498|Other|KD|The group received a plan for a low carbohydrate ketogenic diet
15844572|NCT04086472|Biological|MK-1654|Single dose of MK-1654 administered via IV infusion.
15844573|NCT04086472|Other|Placebo|Placebo (0.9% sodium chloride, USP sterile saline) administered via IV infusion.
15844574|NCT04086472|Biological|RSV-A Memphis 37b|Approximately 4Log10 plaque-forming units (PFU)/mL RSV-A virus inoculation strain Memphis 37b administered via intranasal inoculation.
15844575|NCT04086459|Device|Repetitive transcranial magnetic stimulation|Those receiving experimental treatment will receive 20 sessions of rTMS, stimulation protocol included 20 sessions within 30 days (once a day, 5 days/week, 4 weeks, 10 Hz frequency, pulse intensity 100% of the resting motor threshold, 50 pulses per train, inter train pause of 10 s, 40 stimulation trains, 2000 pulses/ session)
15844576|NCT04086446|Device|high-definition transcranial direct current stimulation|The tDCS device will deliver a direct current of 1.5mA during 20 minutes. Cathode electrode will be localized in front of the right OFC on the Fp2 point according to the EEG international reference. Four anode electrodes will be placed around FP2 (i.e. Fpz, AFz, AF4, AF8)
15844577|NCT04086446|Device|Sham tDCS|The same procedure will be applied except that the tDCS device will only deliver a current stimulation for the first and last 15 seconds.
15844578|NCT04086433|Device|gastric tissue resection|human stomach specimens will be resected with the surgical staplers for pressure testing and staple malformation assessment
15844579|NCT04086420|Behavioral|Mindfulness|Received instructions to exercise at moderate intensity while listening to an audio-recorded mindfulness-based physical activity intervention
15844580|NCT04086420|Behavioral|Heart-Rate|Given a heart rate monitor, told to exercise within the moderate intensity range (64-76% of estimated maximum heart rate)
15844581|NCT04086407|Device|Dual-axis inclinometer attached to the subject's forehead with tape|This is the first clinical trial in the industry to address OSA symptom severity and snoring as a direct function of head pitch and roll angle. The head pitch and roll angle can be used with high consistency to predict OSA symptom severity. The apnea equation is based on the gravitational crush forces of the mass of the tongue and nearby tissue on the upper air way and is valid for most OSA sufferers.
15844582|NCT04086394|Procedure|Pectoral Nerve Block|Patients who were given 20 cc of 0.25% Marcaine as part of the pectoralis nerve block
15844583|NCT04086394|Procedure|Surgery without Nerve Block|Patient's underwent indicated procedure without regional pectoralis nerve block
15844584|NCT04086381|Dietary Supplement|Creatine monohydrate|5 grams of creatine monohydrate, four times daily, for 9 consecutive days.
15844585|NCT04086381|Dietary Supplement|placebo cellulose|oral ingestion of placebo containing 20 gram cellulose daily
15844586|NCT04086368|Device|Adolescent Lateral Entry Femoral Nail|The use of an less invasive implant that has the same accuracy.
15844587|NCT04086368|Device|Pediatric LCP Hip Plate System|Open approach to the femur where the osteotomy and osteofixation with plate and screws are preformed
15844588|NCT04086355|Other|oromotor exercises and neuromuscular electrical stimulations|treatment study group with occupational exercises and electrical stimulation
15844589|NCT04086342|Drug|CHI-902|A standardized cannabis extract in MCT oil administered in oral liquid (oil) form.
15844590|NCT04086342|Drug|Placebo|Placebo is a vehicle oil that will match CHI-902.
15844591|NCT04086329|Device|Nanosensor|"The purpose of the study is to test a device called a nanosensor, which measures oxygen levels (a proxy of mitochondrial function) in muscle. The nanosensor has not been tested in humans nor has it been approved by the FDA.
~The study nanosensor measures 1.8 mm width x 6 mm length x 0.3 mm depth. Placement of the sterilized nanosensor involves a small incision for manual placement of the nanosensor in muscle forearm tissue."
15844592|NCT04086303|Other|LSST test|LSST test: Scapular mobility testing Upper Extremity test: Upper extremity agility and endurance testing Y Balance test: Balance and Coordination testing Sit and Reach Test: Assessment of flexibility
15844593|NCT04086290|Procedure|RARP|Radical prostatectomy + extended pelvic lymph node dissection
15844594|NCT04086290|Radiation|SBRT|Stereotactic body radiotherapy to osseous lesions
15844595|NCT04086290|Drug|ADT|six month of neo-adjuvant/concomitant medical castration therapy using a gonadotropin-releasing hormone antagonist or agonist.
15844857|NCT04084210|Other|Placebo Patch|Placebo patch containing no nicotine.
15844596|NCT04086277|Procedure|Continuous Intrapartum Support|Received the usual obstetric care plus continuous intrapartum support that was provided by a Bachelor of Nursing and Obstetrics who received prior training by a professional doula.
15844597|NCT04086264|Drug|Azacitidine|IMGN632 in combination with azacitidine
15844598|NCT04086264|Drug|IMGN632|IMGN632 in combination with azacitidine
15844599|NCT04086264|Drug|Venetoclax|IMGN632 in combination with venetoclax
15844600|NCT04086251|Other|Gaido|Patients will participate for up to 21 days. Over the course of the study, 25-100 patients will be enrolled.
15844601|NCT04086238|Drug|Decitabine|Capsules containing a combination of decitabine and THU
15844602|NCT04086212|Drug|Icodextrin, xylitol and carnitine solution for peritoneal dialysis|Patients will receive a long dwell exchange for three days.
15844603|NCT04086212|Drug|EXTRANEAL 7.5G/100Ml Peritoneal Dialysis Solution|Patients will receive a long dwell exchange for three days.
15844604|NCT04086199|Procedure|Lumbar discectomy|Lumbar discectomy either by an anterior extraperitoneal approach or by a posterior midline approach.
15844605|NCT04086186|Procedure|Liposomal Bupivacaine Peri-articular Injection|A 20mL solution of 266mg of liposomal bupivacaine (Exparel) was mixed with 40mL of normal saline, which was then infiltrated consistently in the posterior capsule, medial and lateral side of the arthrotomy, patella tendon, quadriceps tendon, quadriceps musculature, and subcutaneous soft tissue.
15844606|NCT04086186|Procedure|Adductor canal block|Anesthesiologist performs preoperative adductor canal block using 15mL of 0.5% Bupivacaine HCl
15844607|NCT04086173|Dietary Supplement|Probiotics|Probiotics will be administered at night and will consist of 4 capsules
15844608|NCT04086173|Other|Placebo|Placebo
15844609|NCT04086160|Device|Transcranial direct current stimulation device (Soterix Medical, New York, NY)|Transcranial direct current stimulation (tDCS) is a non-invasive intervention, which applies low-amplitude direct electric currents to the brain through scalp electrodes. The real (2mA) or sham tDCS intervention will be given for a total of eight sessions in four weeks with 20 minutes per session.
15844612|NCT04086134|Other|Fruit Products|Fruit Products with the potential to improve constipation-related outcomes
15844613|NCT04086121|Drug|Spesolimab|Solution for SC injection
15844614|NCT04086108|Dietary Supplement|Tomato|A maximum of 1 kilo pureed tomatoes, containing 1 gram of GABA.
15844615|NCT04086108|Dietary Supplement|GABA supplement|1 gram of GABA dissolved in water.
15844616|NCT04086108|Dietary Supplement|Glutamate supplement|A maximum of 8 grams glutamate, adjusted to amount of glutamate given in the tomato arm. Dissolved in water.
15844617|NCT04086095|Device|Neofact application aid|The Neofact application aid is a specifically for the LISA procedure designed guide of a soft catheter and replaces the Magill forceps. Catheter (3.5 Fr.) and guide are already combined and packed together sterile. The catheter tip is marked in black (1cm).
15844618|NCT04086082|Device|Markerless Image Guidance|Single arm trial using implanted markers to determine the feasibility of Markerless Image Guidance using Intrafraction Kilovoltage X-ray Imaging
15844619|NCT04086069|Device|Sit-to-stand trainer|The sit-to-stand trainer device is an exoskeleton that enables standing-up movement resembling the movement of a healthy person. It consists of three sub-systems: a foldable chair, a lever for body orientation and a triggering mechanism. It includes a support for feet with adjustable height. The device offers partial support to the patient while standing up. The patient will exercise with the device for 10 sessions (one per day), standing up for up to 30 times per session.
15844620|NCT04086056|Other|NIRS monitoring|Regional cerebral oxygen saturation (rScO₂) will be collected by NIRS monitoring before anesthesia induction, during surgery and after extubation, in children with craniosynostosis.
15844621|NCT04086043|Device|Endovascular Denervation|multi-electrode catheter-based endovascular denervation
15844624|NCT04086017|Other|Reiki therapy|Reiki is a complementary health approach where trained providers place their hands lightly on or just above a person, in discrete positions, with the goal of facilitating the person's own healing response. A Reiki practitioner will perform the initial teaching and instruct the caregivers how to perform a simple 10-minute Reiki and self-Reiki session.
15844625|NCT04086004|Other|Group I Experimental Motor Imagery|The experimental group will receive dual task balance training for 30 minutes/day with additional mental imagery for 10 minutes/day, three days/week, for a period of eight weeks
15844626|NCT04086004|Other|Dual task training|group will receive dual task balance training for 40 minutes for three days/ week for eight weeks
15844627|NCT04085991|Drug|131I-PSMA-1095 Radioligand Therapy (RLT)|Intravenous injection of 100 mCi of 131I-PSMA-1095, Q8 weeks up to a maximum of 4 doses.
15844628|NCT04085965|Behavioral|Boys and Girls Club summer day camp|Daily camp activities included sports, games, obstacle courses, swimming and boating, summer learning and arts and crafts. Lunch was served daily via the USDA's Summer Food Service Program.
15844629|NCT04085952|Procedure|dermal graft (ARCUS repliform) for anterior colporrhaphy|At the time of surgery patients were randomized to anterior colporrhaphy with dermal graft augmentation
15844630|NCT04085952|Procedure|suture based anterior colporrhaphy|At the time of surgery patients were randomized to anterior colporrhaphy with a suture based repair
15844631|NCT04085939|Other|Online survey|Anonymous survey using the online survey tool, JotForm
15844632|NCT04085926|Device|Sealed therapeutic shoe|Off-the-shelf therapeutic shoe and custom-made insole
15844633|NCT04085926|Device|Total contact cast|Custom-made total contact cast
15844634|NCT04085913|Drug|Lidocaine Epinephrine|Preincision injection, as is current practice
15844635|NCT04085913|Drug|Bupivacaine Hydrochloride-EPINEPHrine|Preincision injection
15844789|NCT04084691|Other|Physical exercice - workout|standardized physical activity (bodybuilding) lasting 30 minutes and having a warm-up portion of 5 minutes
15844636|NCT04085913|Drug|Lidocaine Epinephrine, Bupivacaine Hydrochloride-EPINEPHrine|Preincison injection of lidocaine and epinephrine and a postincision injection of Exparel
15844637|NCT04085887|Drug|Panitumumab-IRDye800|Panitumumab-IRDye800 is an imaging agent prepared as a drug-dye compound from panitumumab (Vectibix), a fully-humanized IgG2 monoclonal anti-epidermal growth factor receptor (EGFR) antibody, and IRDye800CW dye. Panitumumab-IRDye800 delivered intravenous (IV).
15844638|NCT04085887|Device|Pinpoint-IR9000 endoscopic/handheld device|"Novadaq intraoperative camera capable of exciting and detecting near infrared (NIR) dyes. Imaging will be performed on subjects during both during surgery (in vivo) and/or on the resected tissues while at the back table in the surgery suite (ex-vivo)."
15844639|NCT04085887|Device|Explorer Air camera|"Surgvision intraoperative camera. Imaging will be performed on subjects during both during surgery (in vivo) and/or on the resected tissues while at the back table in the surgery suite (ex-vivo)."
15844640|NCT04085887|Device|PDE-NEO-II|"Hamamatsu Photonics KK intraoperative camera. Imaging will be performed on subjects during both during surgery (in vivo) and/or on the resected tissues while at the back table in the surgery suite (ex-vivo)."
15844641|NCT04085874|Behavioral|Promotion of Food-based recommendations|Prolonged contact through weekly home visits and monthly group meeting for 12 weeks
15844642|NCT04085874|Behavioral|Nutrition counseling from standard health services care|once nutrition counselling from health services
15844643|NCT04085861|Behavioral|Mental health literacy in dancers|Receive a designed informative intervention (3 workshops of 90min each) aimed at improving their knowledge and skills on proper recovery, performance nutrition, and mental health literacy.
15844644|NCT04085861|Behavioral|Mental health literacy in dance teachers|Receive a designed informative intervention (3 workshops of 60min each) aimed at improving their knowledge and skills on how to identify and deal with mental health- and nutritional issues in dancers.
15844645|NCT04085848|Other|music therapy|4 music therapy sessions during a period of time of 48 hours. Each session lasts 30 minutes.
15844646|NCT04085822|Device|SMA-001|Intra-dermal injection of SMA-001 and control device.
15844647|NCT04085809|Other|AmLactin® Rapid Relief|AmLactin® Rapid Relief, BID application for 14 days. AmLactin is an over-the-counter cosmetic.
15844648|NCT04085796|Other|ICCI|Intentional Compassionate Communication Intervention
15844649|NCT04085783|Procedure|PRP|Platelet Rich Plasma
15844650|NCT04085770|Drug|Alfacalcidol 1 MCG Oral Capsule|2 mcg of oral Bone Care© soft gelatin capsules once daily with food starting from the day of admission till the end of hospital stay
15844651|NCT04085757|Drug|long interval dinoprostone|A small envelope including two labeled plastic bags (A & B) (each bag containing either 1 dinoprostone tablet(3mg) or 1 identically appearing placebo tablet) will be packaged in sequentially numbered sealed envelopes. In long interval dinoprostone group, bag (A) contains dinoprostone tablet and bag (B) contains placebo tablet. After signing the informed consent, the sequentially numbered sealed envelopes will be opened (according to the sequence of attendance of the patient) by the study nurse. Tablets in bag (A) will be inserted 12 hours before office hysteroscopy and tablets in bag (B) will be inserted 3 hours before office hysteroscopy.
15844652|NCT04085757|Drug|short interval dinoprostone|A small envelope including two labeled plastic bags (A& B) (each bag containing either 1 dinoprostone tablet(3 mg) or 1 identically appearing placebo tablet) will be packaged in sequentially numbered sealed envelopes. In short interval dinoprostone group, bag (A) contains placebo tablet and bag (B) contains dinoprostone tablet. After signing the informed consent, the sequentially numbered sealed envelopes will be opened (according to the sequence of attendance of the patient) by the study nurse. Tablets in bag (A) will be inserted 12 hours before office hysteroscopy and tablets in bag (B) will be inserted 3 hours before office hysteroscopy.
15844653|NCT04085744|Drug|Lidocaine 10% Spray|lidocaine will be apply on the cuff
15844654|NCT04085744|Drug|Mometasone nasal spray|mometasone spray will be applied on the cuff
15844655|NCT04085731|Procedure|Catheter ablation|Driver-guided catheter ablation of persistent atrial fibrillation
15844657|NCT04085692|Behavioral|Low-Dose, High-Frequency Simulation-Based Training|"Twelve weeks of LDHF training
~The simulation-based training sessions take place at the EMDC, at extra workstations set-up as ordinary EMD workstations in an out-of-the-way area. Before each session, the EMD is informed about the simulation call and receives instructions concerning technical differences from a regular call. The instructor acts as a standardised caller, guided by a computer program. This program, the Danish version of Resuscitation Quality Improvement for Telecommunicators (Laerdal Medical AS, Stavanger, Norway), is a training program for DA-CPR based on the simulation platform Laerdal Learning Application. This modified version of the RQI-T program has, one test scenario, one data collection scenario and six different cardiac arrests scenarios as well as a feedback checklist based on the Danish dispatcher protocol Danish Index for Emergency Care.
~Each simulation session takes approximately 20 minutes, including introduction and feedback"
15844658|NCT04085679|Other|Multidisciplinary Mobile Unit (MMU)|MMU is called in case of urgent clinical situations involving patients residing in nursing home
15844659|NCT04085666|Drug|CDX 6114|CDX-6114 for oral administration is formulated in phosphate buffer, which also includes mannitol and poloxamer.The vehicle solution provided is identical to the CDX-6114 oral solution except for the active drug.
15844660|NCT04085666|Other|Matching Placebo|The placebo oral dosing solution will also be supplied as an approximately 240 mL oral solution and will be made up of the phosphate buffer diluent and the caramel flavoring.
15844661|NCT04085653|Drug|alpelisib|"Alpelisib will be provided as 50 mg, 125mg and 200 mg film coated tablets as individual patient supply, and will be dosed on a flat scale of mg/day not to be adjusted to body weight or surface area.
~In Adult patients, alpelisib will be administered at a starting dose of 250 mg orally once daily on a continuous dosing schedule and can be adjusted for toxicity per the recommendations in this treatment plan.
~In Pediatric patients, alpelisib will be administered at a maximum starting dose of 50 mg orally once daily on a continuous dosing schedule and can be interrupted for toxicity per the recommendations in this treatment plan; no dose reductions are allowed."
15844858|NCT04084197|Drug|HIP1402|Tamsulosin (HanmiTams Capsule) 0.4mg
15844662|NCT04085640|Other|Obturator nerve block with ropivacaine 0.2%.|20 milliliters of ropivacaine 2 mg/mL will be injected in the interfacial plane between the pectineus and external obturator muscles.
15844663|NCT04085640|Other|Obturator nerve block with isotonic saline|20 milliliters of isotonic saline will be injected in the interfacial plane between the pectineus and external obturator muscles.
15844664|NCT04085627|Drug|Valsartan and Amlodipine Tablets|1 tablet contains Valsartan 80mg& Amlodipine 5mg
15844665|NCT04085614|Device|PCI with Dynamic Coronary Roadmap|Standard of care PCI with Dynamic Coronary Roadmap
15844666|NCT04085614|Device|PCI without Dynamic Coronary Roadmap|Standard of care PCI without Dynamic Coronary Roadmap
15844667|NCT04085601|Drug|APL-2|Complement (C3) Inhibitor
15844668|NCT04085575|Drug|Acide Tranexamique|Recruited patients were randomly before the operation by generating random numbers with Microsoft Excel 2007. They were assigned in two groups: 1 g of intra-articular tranexamic acid (TXA) and 2 g of intra-articular tranexamic acid.
15844669|NCT04085562|Drug|Bisoprolol Fumarate 5-10 mg|Bisoprolol as antihypertensive drug in patients on hemodialysis
15844670|NCT04085562|Drug|Amlodipine 5-10 mg|Amlodipine as antihypertensive drug in patients on hemodialysis
15844671|NCT04085549|Device|Berry Oil Cream|Cream containing berry and plant oils and humectants; a medical device product in development
15844672|NCT04085549|Other|Reference Cream|Commercial refence cream not containing berry and plant oils.
15844673|NCT04085536|Procedure|Dental and medical treatment|If the dental cause of sinusitis is objective, if necessary, dental treatment combined with medical treatment will be carried out.
15844674|NCT04085523|Drug|TransCon CNP|TransCon CNP drug product is a lyophilized powder in a single-use vial containing either TransCon CNP 3.9 mg CNP-38/vial or TransCon CNP 0.80 mg CNP-38/vial. Prior to use, the lyophilized powder is reconstituted with sterile water for injection and administered by subcutaneous injection via syringe and needle.
15844675|NCT04085523|Drug|Placebo for TransCon CNP|Weekly subcutaneously injection of placebo.
15844676|NCT04085523|Drug|sWfI Placebo for TransCon CNP|Weekly subcutaneously injection of placebo.
15844677|NCT04085510|Device|Contrast-enhanced mammogram|Contrast-enhanced mammography (CEM) is a new FDA-approved exam that is similar to magnetic resonance imaging (MRI) in depicting breast cancers due to increased and leaky blood vessels. Contrast-enhanced mammography is used as an adjunct following mammography and/or ultrasound examinations to localize a known or suspected lesion.
15844678|NCT04085497|Other|Treatment|KT application: KT application includes 2 stages. The banding in the first step is directed to the patellar tendon in order to absorb the load of the knee. The second step is directed directly on the medial plica to benefit from its analgesic effect. For the first step, an I-band is measured from the top of the patella to the tuberositas tibia. I-band is 6 cm wide and 5 mm thick. This I-band is cut into Y-band. First, the part of the band above the patella is pasted with 10% tension. Then the patient's knee is flexed to maximum flexion and the tails of the band are pasted around the patella with 0% tension. The tails of the band are combined together on the tuberositas and completed. For the second step, 4 I-bands 8 cm long and 1.5 cm wide are prepared. The middle of the I-bands is attached to the medial plica with a 0% tension, giving a star shape.
15844679|NCT04085484|Dietary Supplement|More concentrated parenteral nutrition solution|This study is a single-center retrospective observational study comparing two cohorts of very low birth weight (VLBW, birth weight < 1500 grams) infants who received parenteral nutrition (PN) either before or after a concentrated PN regime was implemented into clinical use. Both PN regimes were based on standardized PN solutions.
15844680|NCT04085471|Diagnostic Test|CTHRC1 biomarker level in rheumatoid arthritis|measurment of levels of CTHRC1 in patients diagnosed as RA
15844683|NCT04085432|Other|Self administered questionnaire and Clinical evaluation|Self administered questionnaire and clinical evaluation
15844684|NCT04085419|Drug|Denosumab 60 MG/ML Prefilled Syringe [Prolia]|denosumab 60 mg subcutaneously every 6 months
15844685|NCT04085419|Drug|Zoledronic Acid|zoledronic acid 5 mg intravenously once a year
15844686|NCT04085406|Device|Deep Brain Stimulation of the Subgenus Cingulate Cortex|The Abbott Infinity DBS device will be surgically implanted in the bilateral subgenual cingulate cortex to provide electrical stimulation to this region.
15844687|NCT04085393|Drug|GRANISETRON EXTENDED RELEASE INJECTION (GERSC)|GERSC is a new, subcutaneously (SC) administered polymeric formulation of granisetron that was developed to provide slow, controlled, and sustained release of granisetron to prevent both acute and delayed CINV associated with MEC and HEC. Due to the prolonged efficacy, GERSC may potentially improve CINV in the acute and delayed periods and the single dose regimen may improve patient adherence to antiemetic therapy
15844688|NCT04085367|Drug|MAL 16.8% cream|Two treatments of DL-PDT
15844689|NCT04085354|Drug|Multi-Vitamin Tablets|The distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used. Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse.
15844690|NCT04085354|Drug|Dapoxetine|The distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used. Group 2 was given on-demand 30 mg dapoxetine 1-2 h before intercourse.
15844691|NCT04085354|Drug|Dapoxetine and folic acid.|The distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used. Group 3 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg folic acid.
15844725|NCT04085133|Diagnostic Test|Gene Xpert Chest x ray and MSCT chest|Sputum sample for T.B will be done using gene expert device and chest xray and high resolution ct to evaluate bronchectasis
15844826|NCT04084431|Radiation|Radiation|WBRT will be applied in 10 fractions with single doses of 2 Gy (Arm 1) to the whole brain
15844692|NCT04085354|Drug|Dapoxetine and vitamin B12|The distribution of the patients among the four groups was based on randomized coded cards, so the patients were unaware of the type of the drugs used. Group 1 was given placebo in form oral multivitamin tablet 1 h before intercourse. Group 4 was given on-demand 30 mg dapoxetine 1-2 h before intercourse and daily oral supplementation of 0.5 mg vitamin B12
15844693|NCT04085341|Drug|GB-102|Intravitreal injection of GB-102
15844694|NCT04085315|Drug|Osimertinib|Osimertinib is a medication used to treat non-small-cell lung carcinomas with a specific mutation. It is a third-generation epidermal growth factor receptor tyrosine kinase inhibitor. Patients will be receiving full dose osimertinib (80 mg PO daily) as part of the patient's current standard of care.
15844695|NCT04085315|Drug|Alisertib|Alisertib is an orally available selective aurora A kinase inhibitor. Alisertib will be administered to eligible patients in combination with osimertinib at doses ranging from 20 mg to 50 mg PO twice daily on days 1-3, 8-10, and 15-17 of a 28-day cycle. The starting alisertib dose for Cohort 1 will be 30 mg twice daily (dose level 1).
15844696|NCT04085302|Device|Digital Behaviour Change Intervention|14 days
15844697|NCT04085289|Drug|Galcanezumab|Administered SC
15844698|NCT04085289|Drug|Placebo|Administered SC
15844699|NCT04085276|Drug|JS001|JS001 240mg, i.v., q3w; Other name: Toripalimab
15844700|NCT04085276|Drug|Nab-Paclitaxel|Nab-Paclitaxel 125 mg/m2, i.v., d1, d8, q3w
15844701|NCT04085276|Drug|Placebo|Placebo, i.v., q3w;
15844702|NCT04085276|Drug|Nab-Paclitaxel|Nab-Paclitaxel 125 mg/m2, i.v., d1, d8, q3w
15844703|NCT04085263|Procedure|Control group|The patients in this group will receive sham rhomboid intercostal and subserratus plane.
15844704|NCT04085263|Procedure|Rhomboid intercostal and subserratus plane block group|The patients in this group will be receive real ultrasound-guided rhomboid intercostal and subserratus plane.
15844705|NCT04085250|Other|Neoadjuvant therapy|The neoadjuvant therapy before radiotherapy comprised of Docetaxel 60 mg/m2 for 1 hour + Cisplatin 75 mg/m2+Nivolumab 360 mg, once every 3 weeks (Q3W), for a total of 2 cycles.
15844706|NCT04085250|Other|Chemotherapy concurrent with radiotherapy|Docetaxel 25 mg/m2 for 1 hour +Cisplatin 25 mg/m2, once a week (QW)
15844707|NCT04085250|Radiation|Radiotherapy|Hypofractionated radiation technique was used to deliver a definitive radiation dose
15844708|NCT04085250|Drug|Nivolumab|Nivolumab consolidation (360 mg) via iv infusion once every 3 weeks (Q3W)±3 days after the neoadjuvant therapy and concurrent chemo-radiotherapy. Administration of nivolumab will commence on Day 1 following randomisation to Nivolumab after confirmation of eligibility and will continue on a Q3W schedule for a maximum duration of 12 months.
15844709|NCT04085250|Other|Observation|Observation after the neoadjuvant therapy and concurrent chemo-radiotherapy.
15844710|NCT04085237|Drug|Ropivacaine injection|30ml of 0.375% ropivacaine with 5mcg/ml of epinephrine will be injected into the fascial plane on the anterior spinae muscle.
15844711|NCT04085237|Other|Sham|Saline will be used at the same amounts as the ropivacaine arm.
15844712|NCT04085224|Drug|Somatropin|LG Somatropin
15844713|NCT04085198|Procedure|Light physics enhanced 'no-touch' hysteroscopy|The light source used in hysteroscopy provides an illumined environment during the imagination with these techniques. During hysteroscopy, the light reflecting from the adjacent tissue appears bright, however, this reflection is weaker in farther tissue and these structures appear dark. This information will be used in determining the route from the vaginal introitus to the uterine cavity during the hysteroscopy.
15844714|NCT04085198|Procedure|Standard hysteroscopy|Anatomical structures as illumined by the light source of the camera will be used to find the route from the vaginal introitus to the uterine cavity
15844715|NCT04085185|Drug|IBI110|Several dose levels will be evaluated for IBI110 administered as a single agent and in combination with Sintilimab. IBI110 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit. Those who discontinue treatment with single-agent IBI110 may receive combination treatment with IBI110 plus Sintilimab. Combination treatment may continue until disease progression or loss of clinical benefit.
15844716|NCT04085185|Drug|IBI110|IBI110 will be given with RP2D. IBI110 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit.
15844717|NCT04085185|Drug|IBI110+ Sintilimab|"IBI110: Several dose levels will be evaluated for IBI110 in combination with Sintilimab. IBI110 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit.
~Sintilimab: Sintilimab will be given as 200 mg via IV infusion on Day 1 of each 21-day cycle in combination with IBI110. Combination treatment may continue until disease progression or loss of clinical benefit."
15844718|NCT04085185|Drug|IBI110+ Sintilimab|"IBI110: IBI110 in combination with Sintilimab will be given with RP2D. IBI110 will be given via intravenous (IV) infusion on Day 1 of each 21-day cycle until disease progression or loss of clinical benefit.
~Sintilimab: Sintilimab will be given as 200 mg via IV infusion on Day 1 of each 21-day cycle in combination with IBI110. Combination treatment may continue until disease progression or loss of clinical benefit."
15844719|NCT04085172|Drug|Guanfacine hydrochloride (TAK-503)|In both Part A and Part B of the study participants aged 6 to 12 years will receive a dose of 1 to 4 mg and aged 13 to 17 years will receive a dose of 5 to 7 mg TAK-503 oral tablets once daily for 52 weeks.
15844720|NCT04085172|Drug|Atomoxetine hydrochloride|Participants in Part A of the study will receive Atomoxetine hydrochloride oral capsule once daily for 52 weeks.
15844721|NCT04085172|Other|Placebo|In Part A participants aged 6 to 12 years will receive a dose of 1 to 4 mg and aged 13 to 17 years will receive a dose of 5 to 7 mg placebo matched to TAK 503 oral tablets once daily for 18 weeks and placebo matched to atomoxetine hydrochloride oral capsules at once daily for 18 weeks.
15844722|NCT04085159|Biological|Antigen-specific T cells CART/CTL and DCvac|Antigen-specific T cells CART/CTL and DCvac cells to treat cancer
15844765|NCT04084821|Other|none - observation only|Observational retrospective cohort to describe data validity; and Data reliability; and Completeness of the data
15844726|NCT04085120|Procedure|0.75 % Ropivacaine/ 4mg/mL dexamethasone injection|Distal glossopharyngeal nerve in the neck will be blocked by using 0.75 % Ropivacaine/ 4mg/mL dexamethasone injection
15844727|NCT04085120|Procedure|10% lignocaine injection|Distal glossopharyngeal nerve in the neck will be blocked by using 10% lignocaine injection
15844728|NCT04085107|Behavioral|Face-to-face interviews|243 PwMCI will receive two face-to-face interviews to complete two sets of questionnaires, of which 30 participants will be recruited attend a 1-hour semi-structured interview.
15844729|NCT04085094|Dietary Supplement|high-salt diet (V1) and low salt diet (V2)|Before the first visit, the participant will follow a five-day high salt diet (addition of 6g/day of salt to their regular diet followed at home). Before the second visit (V2), the participant will follow for five days a low-salt diet, according to dietary instructions followed provided during the screening visit.
15844730|NCT04085094|Diagnostic Test|Contrast-enhanced ultrasound (CEUS)|Renal ultrasound with use of a contrast product (SonoVue®), perfusion rate 0.015ml/kg/min. Four destruction-reperfusion sequences are performed in order to measure the Perfusion Index (PI) of the renal cortex.
15844731|NCT04085094|Diagnostic Test|functional MRI|Measurement of renal oxygenation with the Blood Oxygenation Level Dependant-MRI technique (BOLD-MRI) on Siemens Prisma 3T scanner before and 15minutes after 0.03mg/kg of IV furosemide. Assessment of the amount of salt stored in the skin and muscles with the 23Na MRI technique.
15844732|NCT04085094|Other|Pilocarpine test|Assessment of sweat salt and potassium concentrations in healthy volunteers according to slat intake. Two electrodes are placed on the forearm. The electric current between the two electrodes will induce perspiration which will be collected with the Macroduct system.
15844733|NCT04085081|Other|E-mail|Receive brief motivational text or email messages
15844734|NCT04085081|Behavioral|Exercise Intervention|Receive personalized walking program plus strength exercises
15844735|NCT04085081|Other|Quality-of-Life Assessment|Ancillary studies
15844736|NCT04085081|Other|Questionnaire Administration|Ancillary studies
15844737|NCT04085081|Behavioral|Telephone-Based Intervention|Receive intervention coaching sessions via telephone
15844738|NCT04085081|Other|Text Message|Receive brief motivational text or email messages
15844739|NCT04085068|Other|cranioscaral treatment|dural release
15844740|NCT04085055|Diagnostic Test|Solid pancreatic mass lesion biopsy|The needle will be used to puncture the lesion and remove a piece of tissue from the mass for histological diagnosis.
15844741|NCT04085042|Device|PIVC pack|The PIVC pack is a sterile container that includes inside all the need devices to perform peripheral catheterization. The pack is color-coded to inform healthcare professionals about the catheter caliber inside.
15844742|NCT04085016|Device|Keratograph 5M, Oculus, Wetzlar, Germany|
15844743|NCT04085003|Procedure|Endovascular repair or Open surgery|The outcomes of different types of repair will be obtained for intact and ruptured abdominal aortic aneurysm
15844744|NCT04084990|Device|S9 VPAP Adapt|Auto-titrated positive airway pressure
15844745|NCT04084977|Diagnostic Test|Antibody detection|detecting anti bodies against D1, D2 receptor, tubolin Lysoganglioside
15844746|NCT04084964|Other|Home-hospitalisation platform for heart failure|The primary objective of the INTERREG NWE-Chance project is the development of an integrated home-hospitalisation platform and the assessment of the feasibility of a home hospitalisation strategy for heart failure patients.
15844747|NCT04084951|Biological|SQZ-PBMC-HPV|antigen presenting cell therapy; therapeutic vaccine consisting of peripheral blood mononuclear cells (PBMCs) manufactured with immunogenic epitopes of HPV16
15844748|NCT04084951|Drug|Atezolizumab|programmed cell death ligand 1 (PD-L1) blocking antibody
15844749|NCT04084951|Drug|Ipilimumab|cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) blocking antibody
15844750|NCT04084951|Drug|Nivolumab|programmed cell death 1 (PD-1) blocking antibody
15844751|NCT04084938|Procedure|Prostate operation or prostate artery embolization|As described above.
15844752|NCT04084912|Drug|Dexamethasone Sodium Phosphate|intravenous injection of one ampoule dexamethasone Sodium phosphate 2 ml 8 mg
15844753|NCT04084912|Drug|Saline Solution|intravenous injection of one ampoule saline
15844754|NCT04084899|Device|Continuous Positive Airway Pressure therapy|Standard treatment with continuous positive airway pressure
15844755|NCT04084873|Behavioral|PBrE|PbRE is a word reading task implementing through an App developed for smartphones. The patient will choose emotional positive and negative words related to personal and clinical characteristics.
15844756|NCT04084873|Behavioral|PBrE-Control|Participants are exposed to several neutral words. These words do not have any emotional content and there are no reasons to think that they have any effect over the emotional regulation.
15844757|NCT04084873|Behavioral|Control|Participants do not receive the intervention.
15844758|NCT04084860|Drug|CI-581a|CI-581a during weeks 1 and 6 at 0.71 mg/kg
15844759|NCT04084860|Drug|CI-581b|CI-581b during weeks 1 and 6 at 0.0125 mg/kg
15844760|NCT04084860|Behavioral|MBRP|MBRP will help with maintaining use reduction/abstinence.In this trial, 3 sessions will occur in the first 2 weeks following the second infusion (weeks 6 and 7), while one session a week will be administered in the latter 5 weeks (weeks 8 through 12).
15844761|NCT04084860|Behavioral|MET|MET may help with goal setting and enhancing engagement with MBRP. In this trial, a standard 5-week MET platform will be provided to individuals randomized to receive behavioral treatment, with an additional session after each infusion (7 sessions total).
15844762|NCT04084847|Dietary Supplement|berberis vulgaris=barberry|10 grams of barberry powder will be consumed daily for 8 weeks.
15844763|NCT04084847|Dietary Supplement|Placebo|Placebo powder
15844764|NCT04084834|Other|Exercise|Participants will be offered to take part in a 5-hour Learning and Mastery-course at Diakonhjemmet Hospital, receiving information about the osteoarthritis disease, symptoms and the importance of exercise and physical activity. Participants will then be given a weekly web-based exercise program (12 weeks) consisting of three aerobic exercise sessions per week. The exercise program consists of five levels, and the participants will each week be guided to the most appropriate level based on their measured physical fitness level and the weekly exercise diary. The participants will at initial assessment at Diakonhjemmet Hospital be instructed to use Borgs scale to adjust exercise level. Based on the weekly exercise diary the participants will also get motivational messages by email.
15844827|NCT04084431|Other|OSC|optimal supportive Care (OSC) alone
15844766|NCT04084808|Dietary Supplement|Solution ingestion|Subjects will be required to ingest 1 liter of the experimental solution, spread over the 45 minutes of exercise. A first ingestion of 167 mL of solution will be made at rest, right before starting warmup, and another dose (167 mL) after it. Four additional doses of 167 mL will be ingested immediately after the first four 3-minute bouts at 95% of Maximal Aerobic Power. A final dose (167 mL) will be ingested after the last effort.
15844767|NCT04084808|Behavioral|Cognitive flexibility|"Subjects will be required to undergo the Stroop task. They will have to answer as quickly as possible, with push buttons, to a colour stimulus, following specific rules, and get the highest possible number of right answers. The flexibility block will show a pre-signal on a screen in front of the subject (a square or a cross will be shown). The form presented will indicate if the subject must use the colour of the writing, or the word written. Each block will consist of 50 trials, 25% of which switching the condition of answer. During this test, reaction time in milliseconds (ms) as well as the number of right answers will be measured.
~This test will be measured before the exercise protocol, during the 3-minutes exercise bouts, and every 15 minutes during the 45 minutes following exercise."
15844768|NCT04084808|Procedure|Brain oxygenation|"Optic imagery (Near-infrared spectroscopy, or NIRS) is a non-invasive technique allowing a fine investigation of the inner workings of the brain. It allows discrimination of oxygenated hemoglobin from deoxygenated hemoglobin, which informs on the coupling between blood flow and oxygen consumption inside the brain. To measure brain oxygenation with NIRS, optodes will be installed on the subject's skin without glue or transmission gel.
~[ Time Frame: During Stroop's task (i.e.before the exercise protocol, during the 3-minutes exercise bouts, and every 15 minutes during the 45 minutes following exercise). ] Measured with near-infrared spectroscopy (NIRS)."
15844769|NCT04084808|Other|Palatability|Subjects will be asked to fill out a short form on the palatability of the solution ingestion, after ingesting the first solution and at the end of exercise, after ingestion the last solution.
15844770|NCT04084808|Procedure|Blood glucose|Blood glucose will be measured with a puncture on the tip of a finger to get a droplet of blood.
15844771|NCT04084808|Behavioral|Perceived exertion|Perceived exertion will be assessed using 3 scales : Borg (RPE), and DP-15 scale for mental effort (Delignières, Brisswalter, & Legros, 1994). These scales will be administrated at the end of each 3 minute high intensity bout.
15844772|NCT04084808|Behavioral|High Intensity Interval Training bouts|6 3-minute bouts at 95% of maximal aerobic power will be done on a bike. Each bout will be separated by 3 minutes of passive recovery. The last bout will be followed by 45 minutes of rest.
15844773|NCT04084795|Behavioral|Eye Movement Desensitization and Reprocessing therapy|"EMDR is a psychotherapeutic approach using a standardized 8-phase protocol to alleviate the distress associated with traumatic memories, facilitating the access to and processing of traumatic memories. Patients will receive 20 individual EMDR sessions of 60 minutes each using the standard protocol, as well as a specific pain protocol and the fibromyalgia protocol. EMDR is an integrative psychotherapy that uses standardized protocols and elements of cognitive-behavioral, interpersonal, and body-centered therapies, as well as dual stimulation (e.g., side-to-side eye movements).
~The current standard protocol includes eight phases:
~Patient history. Patient preparation. Patient assessment. Memory desensitization. Installing the positive cognition. Body scan. Closure. Reevaluation."
15844774|NCT04084795|Other|Multifocal transcranial Current Stimulation|MtCS represents a promising intervention option, given its capacity to modulate cerebral excitability in a simple, safe manner. F3 anodal; AF3, FC1, FC3, FC5, F5, return montage will be used with the anode over the left DLPFC. Half of the patients will receive active stimulation and the other half sham stimulation. Active stimulation will consist of 1mA MtDCS for 20 minutes applied immediately before EMDR sessions. The same protocol and montage will be used for sham stimulation.
15844775|NCT04084782|Device|Fungal Nail Treatment Kit|The treatment kit consists of 5 disposable nail files to be used to remove the top layer of the infected nail at various times throughout the use of the product and a liquid formulation and brush applicator.
15844776|NCT04084769|Biological|Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine MenACYW Conjugate vaccine|Pharmaceutical form: Solution for injection Route of administration: IM
15844777|NCT04084769|Biological|Meningococcal Group B vaccine (Trumenba®)|Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM
15844778|NCT04084769|Biological|Meningococcal group B vaccine (Bexsero®)|Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM
15844779|NCT04084756|Behavioral|Couples Crisis Response Plan|The CCRP is a single session therapist-facilitated suicide prevention intervention conducted with a dyad
15844780|NCT04084756|Behavioral|Mental Health Education|The Mental Health Education session is a single session therapist-facilitated mental health psychoeducation session conducted with a dyad
15844781|NCT04084743|Other|Virtual reality intervention|Virtual reality intervention includes: Maze game software
15844782|NCT04084743|Other|Dual task intervention|The intervention combined both motor and cognitive training which includes, walking 10 meter (1) Free walking (2) Walking carrying an emptying tray (3) Walking carrying a tray with 4 empty glasses (4) Digit calculations (Counting forward and backward, addition, subtraction, multiplication and division) during walking.
15844783|NCT04084743|Other|Conventional physiotherapy|"Gait training in parallel bar
~Balance activities which includes, a. Forward direction activity b. Backward direction activity c. Sideways direction activity"
15844784|NCT04084730|Radiation|Accelerated Partial Breast Irradiation|Treatment will consist of APBI delivered using external beam RT techniques to a dose of 24 Gy in 3 fractions of 8.0 Gy delivered on consecutive weekdays
15844785|NCT04084717|Drug|Crizotinib|"Crizotinib is an orally administered, chemotherapy drug that works by blocking ALK, MET and ROS1 receptor tyrosine kinases from working.
~Participants will receive crizotinib, orally (by mouth), at a dose of 250 mg, twice per day, every day of each 28 day cycle."
15844786|NCT04084704|Device|Cingal|Cingal will be administered by fellowship-trained physicians through ultrasound-guided injection using a 21-gauge needle into the joint space of the hip under sterile conditions. The needle track will be anesthetized with local anesthetic.
15844787|NCT04084691|Other|Physical exercice - moderate intensity|standardized physical activity (moderate intensity) lasting 30 minutes and having a warm-up portion of 5 minutes
15844788|NCT04084691|Other|Physical exercice - high intensity|standardized physical activity (high intensity) lasting 30 minutes and having a warm-up portion of 5 minutes
15844790|NCT04084691|Other|Normal meal|- Hyperlipidic meal Energy supply: 800 kcal Distribution of macronutrients: proteins: 15% +/- 5; carbohydrates: 40% +/- 5; lipids: 45 +/- 5 Choice of foods determined with the dietician taking into account the patient's tastes and products available on the market The same meal will be taken before the 3 sessions concerned.
15844791|NCT04084691|Other|Normalized meal|"- Hyperglucidic meal Energy supply: 800 kcal Macronutrient distribution: protein 15% +/- 5; carbohydrates 60% +/- 5; lipids 25 +/- 2 Choice of foods determined with the dietician taking into account the patient's tastes and products available on the market.
~The same meal will be taken before the 3 sessions concerned."
15844792|NCT04084691|Other|Fasting|non meal in the hour before exercise
15844795|NCT04084665|Drug|Guselkumab|Guselkumab
15844796|NCT04084652|Dietary Supplement|Mycoprotein ingestion|The ingestion of mycoprotein
15844797|NCT04084639|Dietary Supplement|Mycoprotein Ingestion|Ingestion of various doses of mycoprotein compared to placebo control
15844798|NCT04084626|Drug|PD1 antibody|2mg/kg ivgtt on day 1(age<18 years); 200mg ivgtt on day 1(age >=18 years).
15844799|NCT04084626|Drug|lenalidomide|5mg orally once a day（age<18years) ,day 1-14; 10mg orally once a day(age>=18years), day 1-14.
15844800|NCT04084600|Other|Kinesiotherapy Protocol|Kinesiotherapy Protocol is an specific exercise based treatment designed to strengthening, gaining range of motion and stretching the muscles.
15844801|NCT04084600|Other|Manual Therapy Protocol|Manual therapy protocol: is a manual treatment intended to the release of fascias and soft tissues.
15844802|NCT04084600|Other|Traditional Massage|Traditional Massage is a gentle and superficial massage.
15844803|NCT04084587|Device|Retimax Vision Trainer|The Retimax Vision Trainer is an innovative method that aims to increase visual function in patients with eye diseases of various origins and nature, allowing the patient to exploit and optimize their residual visual potential. It is aimed at patients with visual impairments of different origins and severity, such as campimetric deficits, low vision of central origin, degenerative retinal diseases, amblyopia. (1,2) It consists of a device for recording bioelectrical responses evoked during the perception of structured visual stimuli and the control of the same by the patient through a sound biofeedback mechanism. This results in an increase in visual capacity, exploiting neuronal plasticity through the activation of alternative neuronal circuits.
15844804|NCT04084574|Behavioral|DASH diet counseling|Culturally-appropriate, disease-sensitive counseling intervention to enhance DASH diet adherence in Blacks with CKD compared to standard of care condition
15844805|NCT04084561|Behavioral|HRHA|participants will be asked to consider a hypothetical scenario in which genetic test results reveal that: 1) they carry genotypes that place African American smokers at a particularly high (~50%-80%) risk for the development of lung cancer, and 2) their genetic profile reflects a particularly high concordance with African heritage (~90%).
15844806|NCT04084561|Behavioral|LRLA|participants will be asked to consider a scenario in which genetic test results reveal that: 1) they are at normal (~7%-10%) risk for the development of lung cancer, and 2) their genetic profile reflects a particularly low concordance with African heritage (~10%).
15844807|NCT04084561|Behavioral|HRLA|"participants will receive High Risk, Low Ancestry (HRLA) hypothetical"
15844808|NCT04084561|Behavioral|LRHA|"participants will receive Low Risk, High Ancestry (HRLA) hypothetical"
15844809|NCT04084548|Drug|Lidocaine and ketamine|Perioperative lidocaine and ketamine infusion (see below for dosages and timings)
15844810|NCT04084548|Drug|Lidocaine|Perioperative lidocaine infusion (1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hour based on actual body weight; the bolus and infusion will be started after anesthesia induction and before surgical incision, and continued until 1 hour after transfer from the operating room to the PACU)
15844811|NCT04084548|Drug|Ketamine|Perioperative ketamine infusion (0.5 mg/kg bolus followed by an infusion of 0.3 mg/kg/hour based on actual body weight; the bolus and infusion will be started after anesthesia induction and before surgical incision, and continued until 1 hour after transfer from the operating room to the PACU)
15844812|NCT04084548|Drug|Placebo|Perioperative placebo infusion (normal saline)
15844813|NCT04084535|Other|High intensity interval training|Participants will perform 3 HIIT sessions per week, involving 10 min of intense exercise within a time commitment of 30 min per session, including warm-up, recovery between intervals and cool down.
15844814|NCT04084535|Other|Inspiratory muscle training|Participants will perform 3 inspiratory resistance training sessions per week, involving 30 min per session, including warm-up, recovery between intervals
15844815|NCT04084522|Dietary Supplement|Saturated Fat- Desi Ghee (Clarified Butter)|Desi Ghee which is also known as clarified butter contains around 70% of saturated fat. in India it is one of the important culinary items which promotes longevity and protects against various diseases, attributing numerous health benefits. Ghee consumption has also significant hypolipidemic and hypocholesterolemic effects.
15844816|NCT04084522|Dietary Supplement|Soyabean Oil|Soyabean Oil consists of around 84% of unsaturated fat and is the most widely used source of unsaturated fat used in the area.
15844817|NCT04084496|Drug|Folfirinox|Patients will receive mFOLFIRINOX every 2 weeks: Oxaliplatin 65 mg/m2 IV over 3 hours on Day 1; Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; Leucovorin(l-LV) 200 mg/m2 IV over 2 hours on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion.
15844818|NCT04084483|Drug|K-161|K-161 alternate dosage
15844819|NCT04084483|Other|Placebo (Vehicle)|Placebo solution
15844820|NCT04084470|Dietary Supplement|Different types of bread|Three-arm randomized cross-over study. All subjects start with a run-in period of 3 days, thereafter they will receive two different types of bread in a randomized order for 3 consecutive days, with a wash-out period of 11 days in between. After each period, biological samples will be collected.
15844821|NCT04084457|Dietary Supplement|Wild Blueberry powder|Powdered extract obtained from wild blueberries. A daily administration of 27g wild blueberry powder will be administered.
15844822|NCT04084457|Dietary Supplement|Placebo|Identical formulation as the treatment matched for fibre and vitamin C
15844823|NCT04084444|Drug|T8 tablet 0.5mg|Immune regulation, inhibition of acute nonspecific inflammation and chronic inflammation.
15844824|NCT04084444|Drug|T8 tablet 1mg|Immune regulation, inhibition of acute nonspecific inflammation and chronic inflammation.
15844825|NCT04084444|Drug|Placebo|Blank control.
15844828|NCT04084418|Other|Control Diet|Participants will be provided with a two-week menu to be consumed 3 times for each intervention, for a total of 6 weeks per intervention. For the Control diet, the diet will provide 50% of energy from CHO, 15% from protein, and 35% from lipids. Menu will be adapted to the participant's food preferences and usual caloric intake by a dietitian. Participants will be asked to limit their alcohol intake in both interventions. During this phase, participants will also have to wear a pedometer and use the Pezio: Achieve the Guidelines! mobile application to help the research assistant track their daily steps remotely.
15844829|NCT04084418|Other|VLCHF Diet|Participants will be provided with a two-week menu to be consumed 3 times for each intervention, for a total of 6 weeks per intervention. For the Experimental diet, the diet will provide 10% of energy from CHO, 15% from protein, and 75% from lipids. During the Experimental diet, participants will be provided with a multivitamin to reduce risk of deficiencies due to restrictions on fruits and grain products. Menu will be adapted to the participant's food preferences and usual caloric intake by a dietitian. Participants will be asked to limit their alcohol intake in both interventions. During this phase, participants will also have to wear a pedometer and use the Pezio: Achieve the Guidelines! mobile application to help the research assistant track their daily steps remotely.
15844830|NCT04084405|Other|Pulmonary rehabilitation|The experimental group receives inspiratory muscle training and aerobic exercise. The Active Comparator group received only aerobic exercise.
15844831|NCT04084392|Other|Bridge Clinic|Referral to the Bridge Clinic for temporary outpatient addiction treatment while the bridge clinic identifies an outpatient addiction treatment provider to accept the patient for long term treatment.
15844832|NCT04084392|Other|Usual Care|Referral to an outpatient provider for addiction treatment.
15844833|NCT04084366|Drug|OBI-999|For the dose-escalation phase, OBI-999 will be administered on Day 1 of each 21-day cycle, for up to 35 cycles.
15844834|NCT04084366|Drug|OBI-999|For the dose-expansion phase, OBI-999 will be administered on Day 1 of each 21-day cycle, for up to 35 cycles.
15844835|NCT04084353|Other|Intrapartum fetal monitoring training and quality improvement project|Intrapartum fetal monitoring training
15844836|NCT04084340|Procedure|Real transcranial direct current stimulation + therapeutic exercises for urinary incontinence|"Real transcranial direct current stimulation associated with therapeutic exercises for urinary incontinence
~tDCS: 20 minutes, 2mA, motor supplementary area anode and supraorbital cathode (ipsilateral to the dominant lower limb).Technique based on the application of weak, direct electrical current to the brain through relatively large electrodes that are placed over the scalp, in which anodal and cathodal stimulation increases and decreases cortical excitability, respectively."
15844837|NCT04084340|Procedure|Sham transcranial direct current stimulation + therapeutic exercises for urinary incontinence|"Sham transcranial direct current stimulation + therapeutic exercises for urinary incontinence
~tDCS: 20 minutes (30 seconds ON), 2mA, motor supplementary area anode and supraorbital cathode (ipsilateral to the dominant lower limb).Technique based on the application of weak, direct electrical current to the brain through relatively large electrodes that are placed over the scalp, in which anodal and cathodal stimulation increases and decreases cortical excitability, respectively."
15844838|NCT04084327|Other|stastical analysis|1-Clinical examination data-Complete Blood Count (CBC).Bone Marrow Aspiration (BMA)-Bone Marrow Biopsy (BMB). (if available)-Immunophenotyping results (IPT).Cytogenetic results
15844840|NCT04084301|Procedure|High CPB flow|Target CPB flow 2.9 L/min/m2 throughout the CPB period
15844841|NCT04084288|Other|Acupuncture|Ipsilateral Auricular Trauma Protocol (ATP) acupuncture at eight ear points (Hypothalamus, Amygdala, Hippocampus, Prefrontal Cortex, Point Zero, Shen Men, Insula, Vagus) with 30Hz electrostimulation at two of those points (Shen Men and Hypothalamus). Acupuncture needles will be left in place and stimulated for 60 min and then removed
15844842|NCT04084275|Behavioral|breastfeeding education|
15844843|NCT04084275|Behavioral|personal hygiene education|In this training, the puerpera was informed about personal hygiene to prevent infection.
15844844|NCT04084275|Behavioral|nutrition education|In this training, the amount of nutrients that breastfeeding women should take daily was explained.
15844845|NCT04084275|Behavioral|fatigue education|In this training, suggestions were made to prevent the negative effects of fatigue
15844846|NCT04084275|Behavioral|sleep education|In this training, suggestions were offered the puerperants for better sleep. Strategies to improve sleep quality were explained.
15844847|NCT04084275|Behavioral|pilates exercises education|In this study, pilates exercises exclusively for postpartum women were selected from two reference books, Fitness Professional's Handbook and Guide Women's and Fitness Health, which include 13 movements: Bridging, Hundred, Roll Up, One Leg Circle (both ways), Rocker with close legs,Single Straight Leg Stretch, Double Leg Stretch, Spine Stretch Forward, Single Leg Kick, Side Kick up and down, Side Kick circles, Rest position (stretch and relaxation) and Curling. The trainings were provided by the investigator during home visits to the puerpera in the intervention group and the pilates exercises by the investigator who was also a pilates trainer. An appropriate setting was prepared at the homes of puerpera so that they could do the pilates exercises easily.
15844848|NCT04084262|Device|Intramedullary Nail|Subjects undergo a Lapidus Arthrodesis procedure combined with a supinating reduction technique to create a multi-plane correction of hallux valgus
15844849|NCT04084249|Diagnostic Test|ctDNA-analysis|Minimally-invasive blood-based analysis of circulating tumor DNA (ctDNA).
15844850|NCT04084249|Other|Intensified Follow-up Schedule|PET/CT-scans every 3. month
15844851|NCT04084236|Device|electrical stimulation|electrical stimulation
15844852|NCT04084236|Device|Sham|no stimulation
15844853|NCT04084223|Other|Ultrasound|"An Ultrasound exam (not performed in routine care) will be performed at Baseline, 1, 3 and 6 months for protocol.
~All patients will also have CRP dosage (for DAS28 assessment), RAPID-3 and PROs (performed in routine care but analyzed for the study)."
15844854|NCT04084210|Device|Juul Electronic cigarette|The juul e-cigarette pods contain 0.7 ml nicotine by volume / 5% nicotine by weight.
15844855|NCT04084210|Other|Very Low Nicotine Cigarettes|These very low nicotine cigarettes (VLNCs) consist of reduced nicotine cigarettes containing 0.03 mg of nicotine; these VLNCs were obtained from National Institute on Drug Abuse (NIDA's) Drug Supply Program (NOT-DA-14-004).
15844856|NCT04084210|Drug|Active Nicotine Patch|Active nicotine patches, with dosing based on the package insert (>10 cigs/day = 21 mg patch and <11 cigs/day = 14 mg patches).
15844862|NCT04084171|Device|Tandem t:slim X2 with Control-IQ Technology + Dexcom G6|Subjects will use the Tandem t:slim X2 with Control- IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor [CGM].
15844863|NCT04084158|Drug|Toripalimab injection (JS001)|Toripalimab injection (JS001) is a humanized IgG4 monoclonal antibody against the programmed death-1 (PD-1) receptor, blocks the interaction of PD-1 with its ligands and promotes T cell activation in preclinical studies.
15844864|NCT04084158|Drug|Paclitaxel, Albumin-Bound|Paclitaxel
15844865|NCT04084158|Radiation|Radiotherapy|PTV 50.4Gy/28 fractions, PGTV 61.6Gy/28 fractions, once a day, 5 days a week.
15844866|NCT04084158|Drug|Platinum-Based Drug|carboplatin
15844867|NCT04084132|Procedure|Pulmonary valve replacement|Surgical implantation of an adult-sized (≥ 18 mm) homograft or Contegra graft as right ventricle-to-pulmonary artery conduit under cardiopulmonary bypass through a sternotomy.
15844868|NCT04084119|Other|hypopressive abdominal exercise|Participants will perform an hypopressive abdominal exercise program consisting of 18 sessions (6 weeks), 3 times a week, 30 minutes each session.
15844869|NCT04084119|Other|general strengthening exercise|Participants will perform a general strengthening exercise program consisting of 18 sessions (6 weeks), 3 times a week, 30 minutes each session.
15844870|NCT04084106|Drug|Phenoxymethylpenicillin|Oral administration
15844871|NCT04084106|Drug|Amoxicillin|Oral administration
15844872|NCT04084106|Drug|Amoxicillin-clavulanic acid|Oral administration
15844873|NCT04084093|Device|Surfactant Gel|This device is helps in the creation of an optimal moist wound healing environment that aids in protecting healthy tissues and provides an environment conductive to autolytic debridement. The device is 100% water-soluble, biocompatible, and non-ionic. The dressing is a surfactant based gel.
15844874|NCT04084080|Biological|Red Blood Cell|Red blood cell exchange transfusions will be performed every 3-6 weeks to maintain a target post-transfusion hemoglobin S level of <20% and a pre-transfusion hemoglobin S of <30%.
15844875|NCT04084080|Other|Standard of care|NHLBI/ASH/ATS Expert Panel recommended guidelines
15844876|NCT04084067|Drug|Indocyanine Green|IV
15844877|NCT04084054|Diagnostic Test|Ultrasound|Ultrasonic measurement of the optic nerve sheath diameter
15844878|NCT04084041|Device|Simeox|Airway clearance device
15844879|NCT04084041|Other|CCPT|Conventional chest physiotherapy
15844880|NCT04084028|Behavioral|Active Cooking Classes|6 cooking classes will be held every week for 6 consecutive weeks. The lessons are patterned after Dr. Amy Trubek's cooking pedagogy and will be tailored for those cooking for themselves for the first time. Classes begin with a brief lecture on the day's topic. Students will work in teams of 2 in the foods lab to actively practice skills and cook a meal. Students receive recipes and information sheets that cover pantry supplies, grocery lists, knife skills and cooking equipment. All students attend a 2 hour kitchen intensive demonstration as an orientation.
15844881|NCT04084028|Behavioral|Meal Kits|Students receive 6 weeks of home delivered meal kits. Meal kits include ingredients and detailed instructions for 3 meals, which each serve two people. Students may select meals from a list of 18 options that include vegan, vegetarian, and gluten free options.
15844882|NCT04084028|Behavioral|Recipes|Students are emailed a set of recipes once a week for 6 weeks. Recipes include options for breakfast, lunch, dinner, and snacks. Recipe sets include vegan, vegetarian, and gluten-free options. This intervention was cancelled by COVID-related disruptions and did not take place.
15844883|NCT04084015|Device|Axillary Impella®|All enrolled patients will undergo surgical placement of Impella® via axillary artery within 48 hours after peripheral VA ECMO initiation and be managed with early extubation and ambulation strategy
15844884|NCT04084002|Other|physical activity measurement|Physical activity will be measured via accelerometer and self reported questionnaire (Physical activity scale for elderly)
15844885|NCT04083989|Other|Integrative medicine-based multimodal treatment|Multimodal inpatient treatment program based on anthroposophic medicine, including individual and group psychotherapy, family therapy, art therapies and specific nursing applications such as embrocations, rhythmical massage and oil dispersion baths.
15844886|NCT04083976|Drug|Erdafitinib|Participants will receive erdafitinib oral tablets.
15844887|NCT04083963|Drug|Carboplatin|Low dose weekly carboplatin (AUC 2) will be combined with weekly paclitaxel for 12 weeks.
15844888|NCT04083963|Drug|Paclitaxel|Paclitaxel will be given weekly along with carboplatin for 12 weeks.
15844889|NCT04083963|Drug|Doxorubicin|Dose dense doxorubicin will be administered in combination with cyclophosphamide for 4 cycles after weekly carboplatin/paclitaxel.
15844890|NCT04083963|Drug|Cyclophosphamide|Does dense cyclophosphamide will be in combination with doxorubicin for 4 cycles after weekly carboplatin/paclitaxel.
15844891|NCT04083950|Biological|Vivotif Typhoid Oral Vaccine|One capsule is swallowed on alternate days, e.g. days 15, 17, 19, and 21, for a total of 4 capsules.
15844892|NCT04083950|Drug|Aspirin (Positive Control)|Three tablets (325 mg aspirin in each tablet or 975 mg total) are swallowed on days 2 and 3.
15844893|NCT04083937|Radiation|Hypofractionated radiotherapy with photons|hypofractionated radiotherapy with photons (total dose 57.0 Gray in 19 fractions)
15844894|NCT04083937|Radiation|Hypofractionated radiotherapy with protons|hypofractionated radiotherapy with protons (total dose 57.0 Gray relative biological effectiveness (RBE) in 19 fractions)
15844895|NCT04083937|Radiation|Normofractionated radiotherapy with photons|normofractionated radiotherapy with photons (total dose 70.0 Gray in 35 fractions)
15844896|NCT04083924|Other|Basic cardiac ultrasound training with Butterfly iQ handheld ultrasound|Pre-training online module of the American society of Echocardiography and hands-on training of basic cardiac ultrasound with Butterfly iQ handheld ultrasound.
15844897|NCT04083911|Drug|Decitabine, Homoharringtonine, Aclarubicin, Cytarabine and G-CSF|"Decitabine:20mg/m2/d, d1~5, intravenous infusion; Homoharringtonine:1mg/d,d3~9,intravenous infusion; Aclarubicin:10mg/d, d3~d6, intravenous infusion; Cytarabine:10mg/m2,q12h,d3-9, subcutaneous injection;
~Granulocyte colony-stimulating factor:
~50-300μg/d (when WBC counts are less than 20×10^9/L ),subcutaneous injection;"
15844898|NCT04083898|Biological|Isatuximab|Isatuximab will be administered on a 28-day cycle
15844899|NCT04083898|Drug|Bendamustine|Bendamustine will be administered on a 28-day cycle as follows
15844900|NCT04083898|Drug|Prednisone|Prednisone will be administered on a 28-day cycle as follows
15844901|NCT04083885|Other|Virtual Reality|Participants will be provided with a virtual reality training program, personalized with respect to their abilities, endurance, needs and treatment goals. They will be trained to use the program and it will be installed in their home or provided at their long-term care facility. Participants will be suggested to perform VR 3-5 times a week. Sessions will be 20-30 minutes long, depending on tolerance.
15844902|NCT04083872|Drug|Reference drug|D744 Cap. 1 Cap., single oral administration under fasting condition
15844903|NCT04083872|Drug|Test drug|CKD-385 64 mg formulation I Tab. 1 Tab., single oral administration under fasting condition
15844904|NCT04083859|Other|mPATH-Lung|A web-based program that determines patients eligibility for lung cancer screening (LCS), informs them of LCS, presents them with personalized risk-benefit information, helps them make a screening decision, and helps them schedule a LCS clinic appointment.
15844905|NCT04083859|Other|Lung health video|Web-based video about guideline recommended exercise for lung health
15844906|NCT04083846|Drug|Reference drug|D744 Cap. 1 Cap., single oral administration under fed condition
15844907|NCT04083846|Drug|Test drug 1|CKD-385 64 mg formulation I Tab. 1 Tab., single oral administration under fed condition
15844908|NCT04083846|Drug|Test drug 2|CKD-385 64 mg formulation II Tab. 1 Tab., single oral administration under fed condition
15844909|NCT04083833|Drug|Tetrodotoxin|A single TTX dose in a dose ascending study
15844910|NCT04083833|Drug|Placebos|matching placebo comparator
15844911|NCT04083820|Drug|semaglutide|Patients will be treated with commercially available semaglutide in a prefilled pen injector (FlexTouch® variant) according to routine local clinical practice at the discretion of the treating physician. Other anti-hyperglycaemic treatments will be prescribed at the physician's discretion.
15844912|NCT04083807|Biological|TISSEEL Lyo|The dose to be applied is governed by variables including the type of surgical intervention, the size of the affected area and the mode of intended application, and the number of applications.. The guideline for sealing surfaces is one package of Tisseel Lyo 2 ml (i.e. 1 ml sealer protein solution plus 1 ml thrombin solution) is sufficient for a surface of at least 10 cm2.
15844913|NCT04083807|Procedure|Manual compression with surgical gauze pads|Surgical 4x4 inches gauze pads
15844914|NCT04083794|Other|Laboratory based assessments|physical maneuvers to assess physiological responses in bone blood flow
15844915|NCT04083781|Drug|Concizumab|Concizumab will be administered daily subcutaneously (s.c., under the skin). When patients are randomised to concizumab prophylaxis they will receive a loading dose of 1.0 mg/kg concizumab at visit 2a (week 0: arm 2, 3 & 4) or visit 9a (week 24: arm 1) followed by an initial daily dose of 0.20 mg/kg concizumab from treatment day 2. Within an initial 5-8-week dose adjustment period on 0.20 mg/kg concizumab, the patients can be increased or decreased in dose to 0.25 mg/kg or 0.15 mg/kg concizumab. A potential dose adjustment will take place at visit 4a.1 (week 6: arm 2, 3 & 4) or 9a.3 (week 30: arm 1) and will be based on the concizumab exposure level measured at the previous visit 4a (week 4) or 9a.2 (week 28). Patients who have concizumab exposure levels of 200-4000 ng/mL will stay at 0.20 mg/kg concizumab. Patients in arm 1 will continue on-demand treatment with their usual bypassing product until visit 9a (week 24: end of main part for arm 1).
15844916|NCT04083768|Device|15° and 30° wedge sponges|After the spinal anesthesia is completed, the wedge sponge is placed between the patient's pelvis and ribs and the wedge is removed before the skin is cut.
15844917|NCT04083755|Drug|Ferric Carboxymaltose Injection [Injectafer]|1000mg intravenous
15844918|NCT04083755|Other|no treatment or oral iron supplementation|No treatment or treatment oral with iron supplementation if iron-deficiency anemia
15844919|NCT04083729|Procedure|Percutaneous Mitral Commissurotomy|Percutaneous mitral commissurotomy is performed by experienced interventional cardiologists using the Inoue balloon or multitrack technique. During the procedure, conventional hemodynamic parameters are monitored. A successful immediate result is defined as a mitral valve area > 1.5 square cm with less than moderate to severe mitral regurgitation.
15844920|NCT04083716|Drug|ABI-H2158 Reference Formulation|ABI-H2158 tablets Reference Formulation
15844921|NCT04083716|Drug|ABI-H2158 Test Formulation|ABI-H2158 tablets Test Formulation
15844922|NCT04083703|Procedure|Interbody cage insertion in lumbar disc prolapse|Discectomy alone versus interbody cage insertion in treatment of lumbar disc proapse
15844923|NCT04083690|Device|Reprogramming of CRT Device Settings to Optimal Electrical Synchrony|Reprogramming of CRT device to maximize the benefit based on the ECG CRT optimization information.
15844924|NCT04083677|Device|SONAR|A curved low- frequency (2-5 MHZ) probe and (simens ACUSON x 300) ultrasound system will be used. All patient will be first scanned in the supine position, followed by the right lateral decubitus (RLD) position. The gastric antrum was identified in a sagittal scanning plane in the epigastrium immediately inferior to xiphoid and superior to umbilicus. The liver anteriorly and the aorta, inferior vena cava and pancreas posteriorly were used as anatomical reference points.
15844925|NCT04083664|Diagnostic Test|NGAL and Hepcidin|Both NGAL and hepcidin are elevated inchronic kidney disease,not only through iron metabolism, but both are also associated with inflammationand may be related to anemia
15844926|NCT04083651|Drug|Methylnaltrexone bromide|Methylnaltrexone bromide will be administered per dose and schedule specified in the respective arm.
15844927|NCT04083651|Drug|Placebo|Placebo matching to methylnaltrexone bromide will be administered as mentioned in the respective arm.
15844928|NCT04083638|Diagnostic Test|IFAB|Intestinal Fatty Acid Binding Protein will be taken from all participants before the tx and after the tx
15844929|NCT04083625|Drug|carbetocin 100 mcg|a 10 cm syringe containing 100 mcg carbetocin just before skin incision of myomectomy.
15844930|NCT04083625|Drug|placebo|a 10 cm syringe normal saline IV given just before skin incision of myomectomy.
15844931|NCT04083612|Procedure|Venapuncture|Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of ixekizumab
15844932|NCT04083612|Other|Patient questionnaires|The study participant will complete the Dermatology Quality of Life Index (DLQI) and EQ5D5L questionnaires at each study visit.
15844933|NCT04083599|Biological|GEN1042|GEN1042 administered intravenously every 21 days (1Q3W).
15844934|NCT04083599|Drug|Pembrolizumab|Pembrolizumab administered intravenously every 21 days (1Q3W).
15844969|NCT04083352|Dietary Supplement|Pruvit Ketomax Ketone Salt|6-week supplementation with ketone salts
15844935|NCT04083599|Drug|Cisplatin|Cis-/carboplatin + 5FU administered intravenously in combination with GEN1042 + pembrolizumab 1Q3W for 6 cycles followed by GEN1042 +pembrolizumab 1Q3W.
15844936|NCT04083599|Drug|Carboplatin|Cis-/carboplatin + 5FU administered intravenously in combination with GEN1042 + pembrolizumab 1Q3W for 6 cycles followed by GEN1042 +pembrolizumab 1Q3W.
15844937|NCT04083599|Drug|5-FU|Cis-/carboplatin + 5FU administered intravenously in combination with GEN1042 + pembrolizumab 1Q3W for 6 cycles followed by GEN1042 +pembrolizumab 1Q3W.
15844938|NCT04083599|Drug|Gemcitabine|a: GEN1042 1Q3W+ gemcitabine + nab-paclitaxel 2Q3W for a total of 8 cycles; b: GEN1042 + pembrolizumab 1Q3W+ gemcitabine + nab-paclitaxel 2Q3W for 8 cycles followed by GEN1042 + pembrolizumab 1Q3W
15844939|NCT04083599|Drug|Nab-Paclitaxel|a: GEN1042 1Q3W+ gemcitabine + nab-paclitaxel 2Q3W for a total of 8 cycles; b: GEN1042 + pembrolizumab 1Q3W+ gemcitabine + nab-paclitaxel 2Q3W for 8 cycles followed by GEN1042 + pembrolizumab 1Q3W
15844940|NCT04083599|Biological|GEN1042|GEN1042 administered intravenously every 21 days (1Q3W) as per the recommended Phase 2 dose (RP2D) from monotherapy dose escalation.
15844941|NCT04083586|Other|All investigations; laboratory and radiological, needed for diagnosis|mri brain, ct brain, drug screening
15844942|NCT04083573|Other|application of medical augmented reality glasses|Endoscopic images from medical monitor and medical augmented reality glasses will be collected and reviewed. Outcomes from both series of images will be compared
15844943|NCT04083560|Drug|Vit B12|Vitamin B12 250mcg
15844944|NCT04083547|Diagnostic Test|iCellate|New method of circulating tumour cell detection and capture.
15844945|NCT04083534|Drug|REGN5459|Administered by intravenous (IV) infusion
15844946|NCT04083521|Dietary Supplement|Bacillus subtilis DE111®|Subjects were administered a dose of Bacillus subtilis at levels of 1x10^9 CFU once a day for 90-days.
15844947|NCT04083508|Other|Mosquito bites|Successful feeding of 5 infected P. vivax mosquitoes
15844948|NCT04083495|Biological|ATLCAR.CD30 T cells|Autologous T Lymphocyte Chimeric Antigen Receptor cells targeted against the CD30 antigen at dose of 2 × 10^8 CAR-T/m^2 with a maximum dose of 5 × 10^8 CAR-T cells
15844949|NCT04083495|Drug|Bendamustine|70 mg/m^2 administered IV for 3 days for lymphodepletion 2-14 days prior to first cell infusion
15844950|NCT04083495|Drug|Fludarabine|30 mg/m^2 administered IV for 3 days for lymphodepletion 2-14 days prior to first and second cell infusion
15844951|NCT04083495|Drug|Cyclophosphamide|300 mg/m^2 administered IV for 3 days for lymphodepletion 2-14 days prior to second cell infusion and 2-14 days prior to the first cell infusion for subjects who have previously had hypersensitivity to bendamustine
15844952|NCT04083482|Procedure|continous venovenous hemofiltraion|CVVH
15844953|NCT04083469|Behavioral|Peer-Led Peer-Elected Intervention|The intervention will be given to students by a peer opinion leader that the students in the audience elected. The intervention is a version of CATCH My Breath curriculum that has been modified to facilitate peer leadership.
15844954|NCT04083469|Behavioral|Adult-Led Intervention|The intervention will be given to students by an adult. The intervention is a version of CATCH My Breath curriculum that has been modified to match the Peer-Led Intervention curriculum but is able to be administered by an adult.
15844955|NCT04083469|Behavioral|Peer-Led Non-Elected Intervention|The intervention will be given to students by a peer opinion leader that was elected by other students. The intervention is a version of CATCH My Breath curriculum that has been modified to facilitate peer leadership.
15844956|NCT04083456|Behavioral|Walking Biobehavioral Intervention|Each walking biobehavioral training session includes self-monitoring, tailored feedback, identification of barriers and facilitators, problem solving, action planning and encouragement. Self-monitoring of walking behavior will occur with participant use of the FitBit sensor and software, reviewed with the interventionist at each session. Tailored feedback from the FitBit sensor, as well as feedback from the interventionist, will detail progress over time and be compared to baseline data. Barriers and facilitators of reaching activity goals will be discussed with emphasis on problem solving to take advantage of facilitators and minimize/remove participant-specific barriers. Action planning will be based on weekly step goals set collaboratively by the interventionist and participant, based the FitBit data. Finally, encouragement will be provided by the interventionist by putting progress or lack of progress in perspective of the efforts made by the participant.
15844957|NCT04083456|Other|Attention Control|Attention control sessions will include a brief review of the conventional home-exercises, a summary of all healthcare visits and falls, and interventionist-delivered education on safety topics (e.g., fall prevention, wound care, assistive device use). Outpatient therapists will provide home-based exercises to ensure that the participant receives adequate training and demonstrates safe performance prior to home use. The CTL interventionist will assess and discuss the safe performance of each home-based exercise with CTL group participants. Exercises in the CTL group will only be progressed by the outpatient physical therapist and not during the telehealth sessions.
15844958|NCT04083443|Other|Additional blood sampling|Blood samples will be taken to assess antimicrobial drug concentrations and microbial DNA blood counts. Per patient, at least 5 and up to 15 samples for drug concentrations and at least 3 and up to 6 samples for DNA counts are taken for a duration of up to 3 days.
15844960|NCT04083417|Drug|Phenoxymethylpenicillin|tablet PcV 1000 mg x 3 for 10 days
15844961|NCT04083417|Other|No antibiotic treatment|No prescription of antibiotics
15844962|NCT04083378|Procedure|Ablation Therapy|Undergo standard of care ablation
15844963|NCT04083378|Procedure|Image-Guided Therapy|Undergo software-aided imaging (Morfeus)
15844964|NCT04083378|Other|Quality-of-Life Assessment|Ancillary studies
15844965|NCT04083378|Other|Questionnaire Administration|Ancillary studies
15844966|NCT04083365|Drug|Capecitabine|chemoradiation therapy with 825 mg/m2 twice daily capecitabine every day for 5 weeks
15844967|NCT04083365|Drug|Radiotherapy|5040 cGy radiotherapy for 5 days per week for 5 weeks
15844968|NCT04083365|Drug|Durvalumab|One week after the end of CT/RT patients will be treated with 1500 mg IV Q4W durvalumab for 3 administrations
15844970|NCT04083352|Dietary Supplement|Placebo|Placebo was taken for 6-weeks and was calorie and flavor matched to the ketone salt supplement.
15844971|NCT04083339|Drug|AT-001|"AT-001 will be administered as 3 capsules twice daily, before breakfast and before dinner.
~At present AT001 is the sole name for the active substance. No INN/genetic name is available to date"
15844972|NCT04083339|Drug|Placebo|Matching placebo will be administered as 3 capsules twice daily, before breakfast and before dinner
15844973|NCT04083326|Device|Digital Patient Journey Solution|Patients in the intervention arm are provided with a digital patient journey solution used on a mobile device. The application is intended to be used during the whole care path. The patient can familiarize him-/herself to the phases of care through visual timeline representation of the care path, get information on how to prepare for a surgery, receive reminders, fill in questionnaire forms, communicate with the care personnel via messaging functionality and video calls, and search information from frequently asked questions. The application contains information about the preparation, forms for anamnesis, anesthesia and treatment follow-up, information videos and pictures, and timely and individually-tailored reminders, e.g., on when to stop eating and drinking before the surgery. In addition, the application provides instructions on how to arrive to the treatment unit and comprehensive guidance for wound care and rehabilitation at home after the operation.
15844974|NCT04083313|Device|Technique used for closing the appendiceal stump|In all patients, laparoscopic appendectomy is performed, only difference is the way of managing appendiceal stump
15844975|NCT04083287|Other|Erector spinae plane block (Group E)|"Patients will be administered A 400 mg dose of ibuprofen every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.
~Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores at rest and during cough will be recorded at postoperative 1, 2, 4, 8, 16, 24 and 48 hours. If the VAS score will be ≥ 4, 0.5 mg/ kg meperidine IV will be administered. Sedation level will be assessed with a 4-point sedation scale (0 = awake, eyes open, 1 = sleepy but responding to verbal stimulus, 2 = sleepy and hard to evoke, 3 = sleepy, not aroused by shaking). The first time of the use of rescue analgesic, intraoperative and postoperative opioid consumption, side effects such as nausea, vomiting, itching and block related complications will be recorded."
15844976|NCT04083287|Other|Interscalen brachial plexus block (Group I)|"Patients will be administered A 400 mg dose of ibuprofen every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.
~Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores at rest and during cough will be recorded at postoperative 1, 2, 4, 8, 16, 24 and 48 hours. If the VAS score will be ≥ 4, 0.5 mg/ kg meperidine IV will be administered. Sedation level will be assessed with a 4-point sedation scale (0 = awake, eyes open, 1 = sleepy but responding to verbal stimulus, 2 = sleepy and hard to evoke, 3 = sleepy, not aroused by shaking). The first time of the use of rescue analgesic, intraoperative and postoperative opioid consumption, side effects such as nausea, vomiting, itching and block related complications will be recorded."
15844977|NCT04083274|Other|Erector spinae plane block (Group E)|"Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
~Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores at rest and during cough will be recorded at postoperative 1, 2, 4, 8, 16, 24 and 48 hours. If the VAS score will be ≥ 4, 0.5 mg/ kg meperidine IV will be administered. Sedation level will be assessed with a 4-point sedation scale (0 = awake, eyes open, 1 = sleepy but responding to verbal stimulus, 2 = sleepy and hard to evoke, 3 = sleepy, not aroused by shaking). The first time of the use of rescue analgesic, intraoperative and postoperative opioid consumption, side effects such as nausea, vomiting, itching and block related complications will be recorded."
15844978|NCT04083274|Other|Sham block group (Group S)|"Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
~Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores at rest and during cough will be recorded at postoperative 1, 2, 4, 8, 16, 24 and 48 hours. If the VAS score will be ≥ 4, 0.5 mg/ kg meperidine IV will be administered. Sedation level will be assessed with a 4-point sedation scale (0 = awake, eyes open, 1 = sleepy but responding to verbal stimulus, 2 = sleepy and hard to evoke, 3 = sleepy, not aroused by shaking). The first time of the use of rescue analgesic, intraoperative and postoperative opioid consumption, side effects such as nausea, vomiting, itching and block related complications will be recorded"
15844979|NCT04083261|Other|DNA Genotek Oragene 600|Saliva-based DNA sample collection kit
15844980|NCT04083248|Behavioral|Feasibility group|Same as arm description
15844981|NCT04083235|Drug|Irinotecan Liposomal Injection|Irinotecan liposome injection is irinotecan in the form of the sucrosofate salt, encapsulated in liposomes for i.v. infusion. It is supplied in sterile, single-use vials containing 10 mL of irinotecan liposome injection at a concentration of 4.3 mg/mL free base equivalent (FBE).
15844982|NCT04083235|Drug|Oxaliplatin|Oxaliplatin injection, USP is supplied in single-dose vials containing 50 mg, 100 mg or 200 mg of oxaliplatin as a sterile, preservative-free, aqueous solution at a concentration of 5 mg/mL.
15844983|NCT04083235|Drug|5Fluorouracil|Fluorouracil injection, USP is a colorless to faint yellow, aqueous, sterile, nonpyrogenic injectable solution available in 50 mL and 100 mL pharmacy bulk package. Each mL contains 50 mg fluorouracil in water for injection, USP.
15844984|NCT04083235|Drug|Leucovorin|Leucovorin Calcium for Injection is supplied in vials ranging from 50-500 mg and available as an injectable solution or lyophilized powder for reconstitution.
15844985|NCT04083235|Drug|Nab-paclitaxel|Nab-paclitaxel is a lyophilised powder containing 100 or 250 mg of paclitaxel formulated as albumin-bound particles in single-use vials for re-constitution. Each mL of the reconstituted formulation will contain 5 mg/mL paclitaxel.
15844986|NCT04083235|Drug|Gemcitabine|Gemcitabine for injection is a lyophilised powder for solution for infusion, with each single use vial containing 200 mg, 1 g or 2 g of gemcitabine.
15844987|NCT04083222|Drug|IONIS-AGT-LRx|IONIS-AGT-LRx administered subcutaneously
15844988|NCT04083222|Drug|Placebo|Placebo matching IONIS-AGT-LRx solution administered subcutaneously
15844989|NCT04083209|Behavioral|Opioid counseling|The formal opioid counseling will involve reading the recommendations for postoperative opioid use established by the Pennsylvania Orthopedic Society.
15844990|NCT04083196|Biological|11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha)|Injection vaccine produced by ChinaVaccineSerum ,containing HPV antigen protein, 270μg/1ml/bottle
15844991|NCT04083196|Biological|Placebo|Placebo
15844992|NCT04083183|Biological|Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10|Given IV
15844993|NCT04083183|Drug|Fludarabine|Given IV
15844994|NCT04083183|Drug|Cyclophosphamide|Given IV
15844995|NCT04083183|Biological|Lapine T-Lymphocyte Immune Globulin|Given IV
15844996|NCT04083183|Radiation|Total-Body Irradiation|Undergo TBI
15844997|NCT04083183|Procedure|Hematopoietic Cell Transplantation|Undergo hematopoietic cell transplantation
15844998|NCT04083183|Drug|Mycophenolate Mofetil|Given PO or IV
15844999|NCT04083183|Drug|Sirolimus|Given PO
15845006|NCT04083157|Biological|Intradermal hepatitis B vaccine with imiquimod|Intradermal hepatitis B vaccine with topical imiquimod pretreatment
15845007|NCT04083157|Biological|Intramuscular hepatitis B vaccine with aqueous cream|Intramuscular hepatitis B vaccine with topical aqueous cream pretreatment
15845008|NCT04083144|Device|Deep Repetitive Transcranial Magnetic Stimulation (Active)|Active deep rTMS (10 Hz) using the H-coil to target the bilateral insula
15845009|NCT04083144|Device|Deep Repetitive Transcranial Magnetic Stimulation (Sham)|Sham deep rTMS using the H-coil. The sham coil is built into the same helmet as the active coil. It mimics the active coil with regards to acoustics and scalp sensations.
15845010|NCT04083144|Drug|Varenicline|12 week course treatment of varenicline (0.5 mg/1 mg) using the standard dosage schedule for smoking cessation (Day 1-3: 0.5 mg daily; day 4-7: 0.5 mg twice a day; day 8-end of treatment: 1 mg twice a day).
15845011|NCT04083118|Diagnostic Test|clinical evaluation, blood markers, pulse wave analysis, 18F sodium fluoride PET/CT and PET/MRI|Patients will receive a structured clinic history, examination, blood sampling, pulse wave analysis, pulse wave velocity, 18F-sodium fluoride PET/CT, 18F-sodium fluoride PET/MRI with detailed cardiac magnetic resonance imaging and magnetic resonance imaging of the aorta
15845012|NCT04083118|Diagnostic Test|Repeat 18F sodium fluoride PET/MRI|as per first study visit but without the PET/CT
15845013|NCT04083105|Drug|Nitrous Oxide|Nitrous oxide will be given prior to determine if it reduces pain from intranasal midazolam administration. Nitrous oxide is a minimal sedation drug used as an inhaled gas to reduce anxiety and produce anxiolysis and analgesia during dental procedures.
15845014|NCT04083105|Drug|Midazolam|Intranasal midazolam will be given after nitrous oxide administration.
15845015|NCT04083079|Drug|PEG-rhG-CSF|Patients will be given PEG-rhG-CSF for primary/secondary prevention each cycle.
15845016|NCT04083079|Drug|rhG-CSF|Patients will be given rhG-CSF for either primary/secondary prevention or treatment once any neutropenia each cycle.
15845017|NCT04083066|Drug|rituximab in combination with methotrexate, cytarabine and dexamethasone|"Rituximab 375mg/m2D0 is soluble in 0.9% NS concentration 1mg/ml, micro pump is pumped in 4h HD-methotrexate 3.5g/m2 D1 dissolved in 0.9% NS intravenous drip HD-cytarabine 1g/m2 Q12H D2-3 Dissolved in 250ml 5% GS intravenously
~Dexamethasone 40mg D1-5 is dissolved in 100ml 5% GS intravenous drip (21 days is a cycle)"
15845018|NCT04083053|Procedure|Perianal Exam|Perianal Exam is part of anal cancer screening. The perianal skin is also examined under magnification and, less commonly, perianal biopsies are obtained.
15845019|NCT04083053|Procedure|high-resolution anoscopy (HRA) with biopsy|The HRA exam involves insertion of a plastic anoscope 4-6 cm into the anal canal, with use of 5% acetic acid and Lugol's iodine to highlight abnormal lesions for biopsy. The entire squamocolumnar junction is visualized during the exam, which lasts between 5 and 20 minutes.
15845020|NCT04083040|Procedure|transcatheter aortic valve implantation|"Tilt angle.
~Depth of implantation of the valve.
~Type of the valve.(Medtronic core valve self expandable valve ,Edwards sapient balloon expandable valve"
15845021|NCT04083027|Device|MRI|Breast MRI
15845022|NCT04083014|Drug|combination of a single dose anti-CD20 antibody and bortezomib|Relapsed and refractory warm AIHA patients receive treatment of combination of a single dose anti-CD20 antibody and bortezomib twice during three months interval.
15845023|NCT04083001|Device|OTR4132MD|"According to Regulation (EU) 2017/745(MDR), OTR4132-MD is an implantable medical device, for short term use which is specifically intended for use in direct contact with systemic circulation system.
~OTR4132-MD is by definition intended to come into contact with the patient when being injected. It is administered through intra-arterial injection, in an one-shot dose and the majority of the product is eliminated within 24 hours."
15845024|NCT04082988|Diagnostic Test|18F-FDG PET-CT|18F-FDG PET-CT scan
15845025|NCT04082975|Drug|NVP-1203|Oral dose for 7 days
15845026|NCT04082975|Drug|NVP-1203-R|Oral dose for 7 days
15845027|NCT04082975|Drug|NVP-1203 placebo|Oral dose for 7 days
15845028|NCT04082975|Drug|NVP-1203-R placebo|Oral dose for 7 days
15845029|NCT04082962|Drug|Dexamethasone intravitreal implant|Ozurdex™ is an intravitreal implant containing dexamethasone 0.7 mg in the NOVADUR® solid polymer drug delivery system (NOVADUR™ system contains poly (D,L-lactide-co-glycolide) PLGA intravitreal polymer matrix, which slowly degrades to lactic acid and glycolic acid.). Ozurdex™ is preservative-free. It is supplied in a foil pouch with a single-use plastic applicator.
15845064|NCT04082728|Drug|Placebo oral tablet|Patients in the placebo group will be instructed to take a placebo orally three times a day for four days. All patients will be instructed to take ibuprofen 600 mg orally three times a day for four days and 1000 mg paracetamol orally four times a day during the entire study period.
15845085|NCT04082585|Behavioral|Total Health Improvement Program|The Total Health Improvement program is a 13 week community based nutrition program designed to assist participants in improving their physical and emotional well being. The program focuses on a plant based diet and increased physical activity.
15845086|NCT04082572|Biological|Pembrolizumab|Given IV
15845030|NCT04082949|Biological|autologous fibrin glue application as an adjunct to nonsurgical periodontal treatment of chronic periodontitis|The purpose of this study was to investigate effects of autologous fibrin glue (AFG) which was an injectable platelet concentration, on clinical parameters in the nonsurgical treatment of chronic periodontitis.Seventy-two quadrants from 18 patients included in the study and divided into 2 random split-mouth groups. Control group included 631 sites (SRP+Placebo) and AFG group included 682 sites (SRP+AFG). Both groups divided into two subgroups according to initial pocket depth (PD:5-6mm and PD≥7mm).The test group was administered AFG using a blunt dental injector in the subgingival region, as an adjunct to SRP Clinical periodontal parameters including PD, clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were collected at the 1st, 3rd, and 6th months.
15845031|NCT04082949|Other|placebo application as an adjunct to nonsurgical periodontal treatment of chronic periodontitis|Seventy-two quadrants from 18 patients included in the study and divided into 2 random split-mouth groups. Control group included 631 sites (SRP+Placebo) and AFG group included 682 sites (SRP+AFG). Both groups divided into two subgroups according to initial pocket depth (PD:5-6mm and PD≥7mm).The control group was administered placebo as an adjunct to SRP.Clinical periodontal parameters including PD, clinical attachment level (CAL), bleeding on probing (BOP), gingival index (GI) and plaque index (PI) were collected at the 1st, 3rd, and 6th months.
15845032|NCT04082936|Drug|IGM-2323|Subjects with r/r B-cell NHL will receive IGM-2323 via IV infusion.
15845033|NCT04082936|Drug|IGM-2323|Subjects with r/r B-cell NHL will receive IGM-2323 via IV infusion.
15845034|NCT04082923|Other|Liquid meal|Four-hour liquid mixed meal test
15845035|NCT04082923|Other|Solid meal|Four-hour solid mixed meal test
15845036|NCT04082910|Drug|Metoprolol|Metoprolol for patients undergoing CRS after CAR T cells infusion.
15845037|NCT04082910|Drug|anti-TNFα antibody|Metoprolol plus anti-TNFα antibody for patients in prophylactic group.
15845038|NCT04082897|Drug|Obinutuzumab 25 MG/ML [Gazyva]|Obinutuzumab will be administered from C1 to C8
15845039|NCT04082897|Drug|Atezolizumab 60 MG/ML [Tecentriq]|Atezolizumab will be administered iv from C1 to C18
15845040|NCT04082897|Drug|Venetoclax Oral Tablet|Venetoclax will be administered from day 15 cycle 1) until day 21 of cycle 35
15845041|NCT04082884|Behavioral|Very Low Carbohydrate Diet|A very low carbohydrate diet (VLCD), is defined as limiting carbohydrate intake to 11% of total daily caloric intake.
15845042|NCT04082871|Other|Medication management review|The researcher screened each completed an MMR template and verified that all information in each patient template was complete. A classification system was then used to identify the TRPs which either actually or potentially interfered with the clinical outcomes for each patient.[19] This system was explained in detail and applied successfully in many previous studies.[10, 14, 20] The researcher then identified TRPs for each patient in both groups using evidence-based medicine. The TRPs including unneeded drug treatment, untreated condition/s, efficacy/effectiveness issues, safety issues, inadequate knowledge, inappropriate adherence to pharmacological therapy, inappropriate adherence to self-care activities and miscellaneous problems.
15845043|NCT04082858|Drug|Ketamine|A sub-anaesthetic dose of ketamine will be administered in twice-weekly infusions
15845044|NCT04082858|Drug|Midazolam|A sub-anaesthetic dose of midazolam will be administered in twice-weekly infusions
15845045|NCT04082845|Other|Education|Web-based patient education
15845046|NCT04082832|Drug|Cu(II)ATSM|oral suspension
15845047|NCT04082832|Drug|Placebos|oral suspension
15845048|NCT04082819|Device|Contec CMS50EW|Participants' blood pressure will be measured 3 times with the wearable finger pulse oximeter at their study visit.
15845049|NCT04082819|Device|Sphygmomanometer|Participants' blood pressure will be measured 4 times manually with a blood pressure cuff at their study visit.
15845050|NCT04082806|Drug|GHB|50 mg/kg GHB at one experimental night
15845051|NCT04082806|Drug|Trazodone|1.5 mg/kg trazodone at one experimental night
15845052|NCT04082806|Drug|Placebos|placebo oral solution (placebo for GHB) and placebo pills (placebo for trazodon)
15845053|NCT04082793|Combination Product|Photobiomodulation therapy with mandibular exercises|Low-level laser therapy (BMI 1005 Laser 2200) Wavelength: 658 nm Power: 100 MW Energy density: 4J/cm2 Dose administered: 4J Mode: Pulsed Site of application: Over bilateral Temporomandibular joint Number of sessions: 3 sessions/week on alternating days for 12 minutes each, for 4 weeks Mandibular mobilization exercises Side to side movement of the jaw Forward jaw movement Tongue up Goldfish exercise (Partial opening) Goldfish exercise (Full opening) Exercise duration: 6 repetitions X 2 sets X 4 times a day Mandibular Stabilization exercises Exercise duration: 5 repetitions X 3 sec. Hold X 4 times a day
15845054|NCT04082793|Combination Product|Sonophoresis with mandibular exercises|"Ultrasound (BM1-1039) Ultrasonic massage with Diclofenac gel Frequency: 1.0 MHz Mode: Continuous Intensity: 0.8 to 1.5 W/cm2
~Site of application: Over bilateral Temporomandibular joint Number of sessions: 3 sessions per week on alternating days for 8 minutes each, for 4 weeks Mandibular mobilization exercises Side to side movement Forward jaw movement Tongue up Goldfish exercise (Partial opening) Goldfish exercise (Full opening) Exercise duration: 6 repetition X 2 sets X 4 times a day Mandibular Stabilization exercises Exercise duration: 5 repetitions X 3 sec. Hold X 4 times a day"
15845057|NCT04082767|Drug|Precedex|Precedex, dexmedetomidine hydrochloride, IV, 4mcg/mL, infusion duration determined by the clinical care team
15845058|NCT04082767|Drug|Midazolam|Midazolam, IV, 5mg/mL (for patients more than 10kg), 1mg/mL (for patients 2-10kg), infusion duration determined by the clinical care team
15845059|NCT04082754|Biological|Human beta common receptor antagonist monoclonal antibody|Human beta common receptor antagonist monoclonal antibody
15845060|NCT04082754|Drug|Placebo|0.9% sodium chloride, same volume and same duration as CSL311
15845061|NCT04082741|Drug|BMS-986318|Specified dose on specified days
15845062|NCT04082741|Other|Placebo|Placebo Matching BMS-986318
15845063|NCT04082728|Drug|Metamizole|Patients in the experimental group will be instructed to take metamizole 1000 mg orally three times a day for four days. All patients will be instructed to take ibuprofen 600 mg orally three times a day for four days and 1000 mg paracetamol orally four times a day during the entire study period.
15845087|NCT04082559|Other|Arm 1- Antibiotics treatment|Patients with active disease will be randomized and will receive a prescription antibiotic regimens
15845065|NCT04082715|Drug|carbidopa/levodopa and celecoxib|Every patient of this arm will get one bottle of carbidopa/levodopa and one bottle of celecoxib. At treatment initiation, Carbidopa/Levodopa will be taken once daily for 3 days, then twice daily for 3 days, and then thrice daily over one week and then continue on that dose for the duration of the treatment period (12 weeks total). At the last treatment visit (end of the treatment period), patients will begin tapering off the medication as follows. S/he will start with carbidopa/levodopa twice daily for 3 days and then once daily for 3 days before discontinuing it completely.Celecoxib will remain constant once daily for patients of this arm throughout the treatment period, but it will not be given during the tapering down at the end of the treatment period(12 weeks total).
15845066|NCT04082715|Drug|placebo1 and celecoxib|Every patient of this arm will get one bottle of placebo1 and one bottle of celecoxib. At treatment initiation, placebo1 will be taken once daily for 3 days, then twice daily for 3 days, and then thrice daily over one week and then continue on that dose for the duration of the treatment period (12 weeks total). At the last treatment visit (end of the treatment period), patients will begin tapering off the medication as follows. S/he will start with placebo1 twice daily for 3 days and then once daily for 3 days before discontinuing it completely. Celecoxib will remain constant once daily for patients of this arm throughout the treatment period, but it will not be given during the tapering down at the end of the treatment period(12 weeks total).
15845067|NCT04082715|Drug|placebo1 and placebo2|Every patient of this arm will get one bottle of placebo1 and one bottle of placebo2. At treatment initiation, placebo1 will be taken once daily for 3 days, then twice daily for 3 days, and then thrice daily over one week and then continue on that dose for the duration of the treatment period (12 weeks total). At the last treatment visit (end of the treatment period), patients will begin tapering off the medication as follows. S/he will start with placebo1 twice daily for 3 days and then once daily for 3 days before discontinuing it completely. placebo2 will remain constant once daily for patients of this arm throughout the treatment period, but it will not be given during the tapering down at the end of the treatment period(12 weeks total).
15845068|NCT04082702|Behavioral|Faith-enhanced diabetes prevention program|The faith-enhanced curriculum was faith-based and developed using CBPR approaches. The Faith-DPP condition included delivery of the DPP. The group intervention was delivered by one to two trained peers from the church and consisted of 16 weekly group meetings followed by 6 bi-monthly or monthly maintenance sessions. The faith enhanced curriculum included five strategies: 1) a mini sermon (~15 min in length) delivered by a pastor (head pastors were required to deliver at least one per month), first lady, or church leader (pastor associate, deacon, elder, etc.), 2) a memory verse, 3) in class or take-home faith activity (application of faith principles), 4) promises to remember, and 5) scripture and prayer integrated into participant curriculum and facilitator materials. These five faith enhancements were developed by the CAB to enhance the DPP's weekly learning objectives, which resulted in faith components specifically linked to each week of DPP content.
15845069|NCT04082702|Behavioral|Standard diabetes prevention program|The S-DPP condition was faith-placed, a secular program (the DPP) held at an faith-based organization. This condition received the same diabetes prevention program (DPP) as the Faith-DPP, but did not receive any faith enhancements or pastor involvement.
15845071|NCT04082676|Drug|Hyperbaric bupivacaine spinal|In this group patient will receive intrathecal hyperbaric bupivacaine based on patients height and weight according to Harten chart with 10 μg of fentanyl (0.1 ml)
15845072|NCT04082676|Drug|Hyperbaric bupivacaine spinal|In this group will receive intrathecal hyperbaric bupivacaine based on patients height (0.06mg/cm) with 10 μg of fentanyl (0.1 ml)
15845073|NCT04082663|Device|Dental Mouthpiece|Participants will complete motor tasks with and without the dental mouthpiece during the in-person baseline visit. They will also be asked to wear the mouthpiece for one month, and complete sleep and quality of life questionnaires before and after wearing the mouthpiece.
15845074|NCT04082650|Drug|vitamin D|4000IU per day
15845075|NCT04082650|Other|Placebo|The same doses with vitamin D
15845076|NCT04082637|Behavioral|Mindful Awareness in Body-oriented Therapy|A mind-body intervention designed to teach interoceptive awareness skills for emotion regulation and self-care. Delivered individually in 75 minute sessions once a week for 8 weeks.
15845077|NCT04082624|Behavioral|Nutrition condition|Received nutritional information in in-person PowerPoint presentations.
15845078|NCT04082624|Behavioral|Affective condition|Received information about affective benefits of less sitting in the workplace in in-person PowerPoint presentations.
15845079|NCT04082624|Behavioral|Instrumental condition|Received information about instrumental benefits of less sitting in the workplace in in-person PowerPoint presentations.
15845080|NCT04082624|Behavioral|Self-regulation condition|Learned how to self-regulate behavior to sit less in the workplace in in-person PowerPoint presentations.
15845081|NCT04082611|Behavioral|Data-Driven Clinical Recommendations|Data-driven clinical recommendations. Participants will receive routine care with data-driven, personalized, multi-modal clinical recommendations by a study physician based on study assessments and clinical lab values and be monitored and re-assessed for a period of 12 months.
15845082|NCT04082611|Behavioral|Coached Data-Driven Clinical Recommendations|Data-driven multi-modal lifestyle intervention with coaching. Participants will receive coached routine care with data-driven, personalized, multimodal recommendations. MMIC participants will receive an intensive multi-modal intervention with health coaching, support and resources to carry out these recommendations. This additional intervention services include: 13 personal, data-driven brain health coaching sessions (with an RDN), 7 personal dietary counseling sessions (with an RDN), 33 group-based cognitive and physical exercise classes (CogFit) with a certified personal trainer and a computer-based neurocognitive program at home and be monitored and re-assessed for a period of 12 months.
15845083|NCT04082598|Drug|Amoxicillin Clavulanate|tooth extractions are performed for all groups and antibiotics prescribed according to the allocation to the different arms
15845084|NCT04082598|Dietary Supplement|Bifidobacterium longum and Lactoferrin|
15845088|NCT04082559|Other|Arm 2- Antibiotics treatment|Patients with active disease will be randomized and will receive a prescription antibiotic regimens
15845089|NCT04082559|Other|Arm 1- Combination therapy (Antibiotics + diet)|Patients with active disease receiving a prescription for the antibiotic regimen defined as favorable in the antibiotics according to aim 1 , and randomized into one of two dietary interventions: Mediterranean diet (MED) or the specific carbohydrate diet (SCD).
15845090|NCT04082559|Other|Arm 2- Combination therapy (Antibiotics + diet)|Patients with active disease receiving a prescription for the antibiotic regimen defined as favorable in the antibiotics according to aim 1 , and randomized into one of two dietary interventions: Mediterranean diet (MED) or the specific carbohydrate diet (SCD).
15845091|NCT04082559|Other|Arm 1- Nutritional prevention|Patients in clinical remission will be recruited to a dietary prevention study
15845092|NCT04082559|Other|Arm 2- Nutritional prevention|Patients in clinical remission will be recruited to a dietary prevention study
15845093|NCT04082559|Other|Arm 3- Nutritional prevention|Patients in clinical remission will be recruited to a dietary prevention study
15845094|NCT04082546|Procedure|Surgical unroofing of muscle-briged coronary artery|Medical therapy with beta-blockers or calcium-channels blockers
15845095|NCT04082533|Drug|Hydrocortisone|Patients will be receiving 100 mg intravenous hydrocortisone every 8 hours, starting in the holding area roughly 2 hours prior to first incision.
15845096|NCT04082533|Drug|Dextrose 5% in water (D5W)|Patients will be receiving a matched volume of D5W every 8 hours, starting in the holding area roughly 2 hours prior to first incision.
15845097|NCT04082520|Radiation|Gallium Ga 68-DOTATATE|Given IV
15845098|NCT04082520|Drug|Lutetium Lu 177 Dotatate|Given IV
15845099|NCT04082520|Procedure|Magnetic Resonance Imaging|Undergo PET/MRI
15845100|NCT04082520|Procedure|Positron Emission Tomography|Undergo PET/MRI
15845101|NCT04082520|Other|Quality-of-Life Assessment|Ancillary studies
15845102|NCT04082520|Other|Questionnaire Administration|Ancillary studies
15845103|NCT04082507|Diagnostic Test|Serum alpha-fetoproteine|Midtrimesteric serum alpha-fetoprotein mesurment with 2D US and 3D power Doppler with MS US scan .
15845104|NCT04082494|Device|Music via internet and noise canceling headphones|Optional music via internet and noise canceling headphones will be offered.
15845105|NCT04082494|Other|Beverages|Beverages will be optionally offered (with and without sugar, warm or cold).
15845108|NCT04082468|Diagnostic Test|Blood sample collection for coagulation profile|Factor VIII Activity Level, Factor VIII Antigen Level, Interleukin 6, vWF Antigen Level, Thrombin Activity, Protein C Activity, Protein C Antigen Level, CRP, PT/PTT/INR ,T & B lymphocyte panel at above time points
15845109|NCT04082455|Radiation|carbon ion radiotherapy|carbon ion radiotherapy
15845110|NCT04082442|Drug|Evolocumab|420 mg evolocumab.
15845111|NCT04082442|Drug|Placebos|Matching placebo.
15845113|NCT04082416|Biological|Placebo plus standard therapy|"Standard therapy comprises any of the following (alone or in combination):
~corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive and immunomodulator therapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,Tacrolimus ,ciclosporin )"
15845114|NCT04082416|Biological|RC18 160 mg plus standard therapy|Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive and immunomodulator herapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,Tacrolimus ,ciclosporin )
15845115|NCT04082403|Procedure|Training on Suction Assisted Laryngoscopy and Airway Decontamination|Education on Suction Assisted Laryngoscopy and Airway Decontamination, via 30 minute teaching session, followed by practical demonstration of techniques.
15845116|NCT04082403|Procedure|No Training on Suction Assisted Laryngoscopy and Airway Decontamination Provided|No Training on Suction Assisted Laryngoscopy and Airway Decontamination provided to trainees
15845117|NCT04082390|Dietary Supplement|RELEASE|Dietary supplement
15845118|NCT04082390|Dietary Supplement|Placebo|Placebo
15845119|NCT04082377|Procedure|Recruitment maneuver with tidal volume (RM TV)|"The ventilation protocol consisted of volume controlled mechanical ventilation, FiO2 0.4, inspiratory-to-expiratory (I:E) ratio at 1:2, and respiratory rate (RR) set to normocapnia (end-tidal CO2 partial pressure between 35 and 40mmHg, TV 6 mL/kg PBW and 5 cmH2O PEEP.
~RMs were conducted under volume controlled ventilation with initial settings of a limit of peak inspiratory pressure at 40cmH2O, TV at 6 mL/kg PBW (PBW = 50.0+0.905*((height in cm)-152.4) for men, and = 45.5+0.905*((height in cm)-152.4) for women) Brower, et al. 1999, RR at 7 breaths/min, PEEP at5 cmH2O, and I:E ratio at1:1. The TV was then increased by steps of 4 mL/kg PBW until plateau airway pressure (Pplt) was 40 cmH2O, after which 3 breaths were allowed. Finally, the limit of peak inspiratory pressure, TV, RR, and I:E ratio were reset at values equal to those preceding the RM."
15845120|NCT04082377|Procedure|Recruitment maneuver by PEEP (RM PEEP)|The ventilation protocol consisted of volume controlled mechanical ventilation, FiO2 0.4, in RMs was conducted under pressure controlled ventilation so ventilation technique will be changed, pressure-control mode will be started and inspiratory time is increased to 50% (inspiratory: expiratory ratio will be set to 1:1). Peak airway inspiratory pressure (Ppeak) will be initially set to 20 cmH2O for three breaths, and then PEEP will be increased in steps from 5 to10 cmH2O for five breaths, from 10 to 15 cmH2O for seven breaths, from 15 to 20 cmH2O for ten breaths while Ppeak increased to 40 cmH2O and will be maintained for three more breaths. Following ARM, volume control will be re-established using Vt 6 mL/kg and step-wise reductions in PEEP from 20 to 15 cmH2O for three breaths,and then to 5 cmH2O until the end of recruitment maneuver
15845126|NCT04082351|Dietary Supplement|Nanotechnology structured water ( Magnalife)|Nanotechnology structured water ( Magnalife), is given as dietary supplement to the patients to drink it according to their weight .
15845127|NCT04082351|Dietary Supplement|ordinary water|Ordinary bottled water
15845128|NCT04082338|Behavioral|VPN|"The intervention will be delivered through virtual patient navigation (VPN) toolkit system (a web/mobile application). The system includes education modules on HBV management, CHB patient success stories and virtual patient navigation clinical support for overcoming barriers.
~In addition to the VPN, each participant will receive 5 text messages; one message once a week for 5 weeks on HBV management for every 6 months in the 18-month study period."
15845129|NCT04082338|Behavioral|TM|Receive TM on HBV management respectively once a week for 5 weeks for every 6 months in the 18-month study period.
15845130|NCT04082325|Drug|Lu AF88434|Lu AF88434, single oral solution Starting dose will be 0.2 mg, actual doses for following cohorts will be defined based on results from preceding dosing group(s).
15845131|NCT04082325|Drug|Lu AF99722 14C spiked dosage ([14C]-radiolabelled Lu AF88434)|Oral solution
15845132|NCT04082325|Drug|Lu AF99723 14C spiked dosage ([14C]-radiolabelled Lu AF88434)|Oral solution
15845133|NCT04082325|Drug|Placebo|Placebo to Lu AF88434 oral solution, single dose
15845134|NCT04082312|Other|No intervention|No intervention
15845135|NCT04082286|Other|Yttrium-90 labelled monoclonal antibody against CD66|
15845136|NCT04082273|Device|Femtosecond Laser for Cataract Surgery|Cataract Surgery on study eye according to conventional procedure, with the exception of three steps (Capsulotomy, Lens Fragmentation and Clear Corneal Incisions) which are performed with a Femtosecond Laser in the laser treatment group. Equipment uesd for measurements is the same for both groups and in line with the normal equipment used for the conventional cataract treatment
15845137|NCT04082273|Other|Conventional Cataract Surgery|Cataract surgery will be performed conventionally, this means the clear corneal incisions will be performed manually by a blade, the capsulorhexis will be performed manually by a hook, and the lens extraction will be done by phacoemulsification
15845138|NCT04082260|Drug|Alemtuzumab Injection [Lemtrada]|"Administration of 2 courses of alemtuzumab at an interval of 1 year. Course 1: Intravenous infusion of 12 mg alemtuzumab per day on 5 consecutive days.
~Course 2: Intravenous infusion of 12 mg alemtuzumab per day on 3 consecutive days."
15845139|NCT04082247|Behavioral|The education and training of early childhood educators and their intervention on children|"A 24-week cluster randomized trial will be developed, with the childcare being the randomization unit. Training sessions will be conducted for all early childhood educators in the intervention group. The control group will receive the Portuguese standard education and at the end of the intervention this group will also receive the initial training given to the intervention group, so that they can later also implement the intervention. At the end of the intervention, all early childhood educators and parents/guardians will have access to the intervention outcomes."
15845224|NCT04081480|Drug|Valacyclovir|PK curve collection to determine acyclovir exposure after administration of valacyclovir oral solution
15845225|NCT04081467|Other|Bed rest|10-day of complete bed rest
15845226|NCT04081454|Behavioral|Workshop|one-day (6 hour) program to help children and their parents or caregivers learn how to better manage chronic pain
15845140|NCT04082234|Behavioral|Partnering to Achieve School Success (PASS)|Individualized parent training program delivered at child's primary care provider office. Providers use engagement and motivation strategies during each session to reinforce help-seeking behavior and family empowerment, and encourage family adherence to recommended strategies. Also includes regular communication between pass provider and PCP and development of a problem-solving partnership between parents and teachers to address school problems. Families are supported in between sessions by a Community Health Partner who contacts families to promote attendance and implementation of strategies and assist in resolving barriers to treatment. The intervention is up to 12 sessions over the course of 16 weeks depending on caregiver goals.
15845141|NCT04082234|Other|Treatment as Usual (TAU) plus Family Education|Caregivers will work with their primary care physician to address their child's ADHD. Primary care physicians have been trained in and informed of American Academy of Pediatrics guidelines for treating ADHD. Treatment may include strategies to educate families about ADHD and evidence-based treatments, refer families to community mental health agencies that deliver evidence-based behavioral programming (other than PASS), engage families in shared decision making, titrate medication, and monitor treatment effects. In addition, families will have access to integrated behavioral health services that are typically offered at their child's primary care office.
15845142|NCT04082221|Other|no intervention|no intervention
15845143|NCT04082208|Device|High Flow nasal cannula|Administration of high flow nasal cannula during ERCP procedure
15845144|NCT04082208|Device|Low Flow nasal cannula|Administration of low flow nasal cannula during ERCP procedure: standard care
15845145|NCT04082195|Other|Fooya mobile game|An application that incorporates the science and technology of immersive gaming, neuropsychology and cognitive behavior therapy in a mobile health game to target early childhood nutrition literacy and health promotion in a fun and exciting way.
15845146|NCT04082195|Other|Uno board game|A popular board game which is not a mobile app.
15845147|NCT04082182|Biological|Dendritic cell immunotherapy|Intravenous infusions of MIDRIX4-LUNG DCs every 2 weeks, using an intra-patient dose escalation scheme progressing along the following range: 10 x10E6 DCs (minimal dose), 20 x 10E6 DCs, 40 x 10E6 DCs, 80 x 10E6 DCs, 100 x 10E6 DCs (maximal dose), until exhaustion of the batch or occurrence of grade ≥3 toxicity event
15845148|NCT04082182|Biological|Antigen-specific DTH|Intradermal injection of 1 x 10E6 MIDRIX4-LUNG DCs at baseline and after completion of all i.v. DC vaccination rounds. This is used for assessment of induction of antigen-specific immune responses as part of in vivo immunomonitoring (delayed-type hypersensitivity cutaneous reaction as test read-out)
15845149|NCT04082182|Biological|Control DTH|Intradermal injection of 1 x 10E6 MIDRIX-CTRL DCs at baseline and after completion of all i.v. DC vaccination rounds. This is used for assessment of background (i.e. non-antigen-specific) reactivity (delayed-type hypersensitivity cutaneous reaction as test read-out)
15845150|NCT04082156|Device|electrical stimulation|electrical stimulation
15845151|NCT04082156|Device|Sham|no stimulation
15845152|NCT04082143|Device|Allograft mucosal enhancement with dental implant|implant placement with allograft mucosal enhancement
15845153|NCT04082143|Device|No allograft mucosal enhancement at time of dental implant placement|implant placement without allograft mucosal enhancement
15845154|NCT04082130|Procedure|(XCM)+(CAF)|The description of this intervention has been already given before.
15845155|NCT04082130|Procedure|(SCTG)+(CAF)|The description of this intervention has been already given before.
15845156|NCT04082117|Behavioral|Educational video|Educational genetic counseling video
15845157|NCT04082104|Diagnostic Test|Stuttering Severity Instument version 3|Riley's Stuttering Severity Instrument is used for the objective assessment of severity and in other examinations of stuttered speech. Current versions of the instrument measures three parameters: 1) stuttering frequency; 2) duration of selected stutters; 3) observed physical concomitants.
15845158|NCT04082091|Behavioral|SELECT mHealth Program|"Individuals will be screened via the telephone, using a mobile-based algorithm that prompts questions about hypertension, risk of Diabetes Mellitus, use of smokeless tobacco and smoking, level of physical activity, and main nutritional choices. These questions are based on tools that have been validated in studies undertaken in this population and will be directly administered by trained research staff of Aga Khan University. Screening will prompt triage into three categories: high - referred to the conveniently located integrated medical center for a medical teleconsultation and fasting glucose test; medium - receive fasting glucose test and BP measurement; and low risk. All subjects in each category will be enrolled in an e_Prescription intervention for lifestyle change tailored to their individual risk profile."
15845159|NCT04082065|Other|conventional physical therapy|hot pack for 15 minutes Myofacial release (10 minutes) and Stretching of hamstrings and Piriformis (5 reps each with 2 second hold)
15845160|NCT04082065|Other|cyriax lumber manipulation group|Hot Pack, Myofacial Release, stretching of hamstrings and Piriformis (five reps each with 2 seconds hold) and Cyriax Lumbar Manipulation Techniques
15845161|NCT04082052|Behavioral|Single Session Interventions|A single session intervention either active (for self-dislike) or placebo (feelings disclosure)
15845162|NCT04082039|Other|convetional PCA method unsing only 1-channel|Ch-1 (flow 2 ml/hr with bolus 2ml/30min lock-out): fentanyl 16 µg/kg, ketorolac 2 mg/kg, ondansetron 12 mg (total volume 100 ml with normal saline); Ch-2 (flow 2ml/h): 100ml normal saline only (for blinding)
15845163|NCT04082039|Other|utilizing 2-channel|Ch-1 (flow 2 ml/hr with bolus 2ml/30min lock-out): fentanyl 16 µg/kg (total volume 100 ml with normal saline; Ch-2 (flow 2ml/h fixed): ketorolac 2 mg/kg, ondansetron 12 mg (total volume 100 ml with normal saline)
15845164|NCT04082026|Behavioral|Early Adolescent Skills for Emotions EASE)|"EASE is conducted in 7 weekly group sessions with adolescents. EASE sessions help adolescents:
~Identify their feelings and body reactions
~Practice breathing exercises
~Get active: Make a plan to positively change their actions
~Manage their problems"
15845187|NCT04081805|Procedure|LASER|The patient will use intravaginal estriol, daily for 2 weeks and them twice a week for 3 months . Each 30 days, the patients will have an appointment when will be checked the weight of the estriol tube to verify the correct use.vulvar application of LASER, to postmenopausal genitourinary syndrome. The patient will be in gynecological position, after remove of vaginal secretion, with gauze and under topic anesthesia, the LASER will be applied, according to the protocol of the manufactured.
15845311|NCT04080817|Other|Speech therapy|standard logopedic speech therapy. Same frequency & intensity as in the other interventions
15845165|NCT04082013|Other|Hamstring Flexibility|"The active knee extension test has been proposed as the gold standard for assessment of hamstring flexibility, as it utilizes readily available equipment and offers a quick, reliable, and low-cost alternative for measurement of hamstring flexibility (Connor et al; 2015).
~The subject will be instructed to maintain 90° hip flexion in the supine position.
~Then asked to actively extend the knee joint.
~The degree of achieving active knee extension will be measured using a universal goniometer.
~The average of three active knee extension measurements will be used as the hamstring muscle length for the data analysis (Dong-Kyu Lee, et al; 2018).
~the procedures will be done with opposite-leg flexed, then repeated with opposite-leg extended."
15845166|NCT04082000|Drug|BOL-DP-o-04|BOL-DP-o-04
15845167|NCT04082000|Drug|Placebo|Placebo
15845168|NCT04081987|Device|non-invasive monitoring|Comparing blood pressure (diastolic & systolic), heart and respiration rates, blood oxygen level and body temperature measurement using the BiPS non-invasive monitor to an arterial line.
15845169|NCT04081974|Other|Distal leg perfusion|On arrival in the operating room, oximeter pads of a NIRO-200NX (NIRO,Hamamatsu® , Japan) NIRS monitor will be placed on the muscles of the calf bilaterally. Lower extremity NIRS is an added monitoring tool as it is currently not being used in our institutional clinical management. Neither anesthetic nor surgical plans will be altered by the study and are left to the discretion of the attending consultant. Also, perfusion goals may not be altered to the results of the leg NIRS. Therefore, the NIRS display will be covered in the operating room throughout the surgery.
15845170|NCT04081961|Device|Anamed OEM device; Air Next mobile spirometry device|Anamed OEM (Original Equipment Manufacturer) device - physical activity and vital signs monitoring; Air Next mobile spirometry device
15845171|NCT04081948|Other|Erector spinae plane block (Group E)|"Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
~Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores at rest and during cough will be recorded at postoperative 1, 2, 4, 8, 16, 24 and 48 hours. If the VAS score will be ≥ 4, 0.5 mg/ kg meperidine IV will be administered. Sedation level will be assessed with a 4-point sedation scale (0 = awake, eyes open, 1 = sleepy but responding to verbal stimulus, 2 = sleepy and hard to evoke, 3 = sleepy, not aroused by shaking). The first time of the use of rescue analgesic, intraoperative and postoperative opioid consumption, side effects such as nausea, vomiting, itching and block related complications will be recorded."
15845172|NCT04081948|Other|Sham block group (Group S)|"Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
~Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores at rest and during cough will be recorded at postoperative 1, 2, 4, 8, 16, 24 and 48 hours. If the VAS score will be ≥ 4, 0.5 mg/ kg meperidine IV will be administered. Sedation level will be assessed with a 4-point sedation scale (0 = awake, eyes open, 1 = sleepy but responding to verbal stimulus, 2 = sleepy and hard to evoke, 3 = sleepy, not aroused by shaking). The first time of the use of rescue analgesic, intraoperative and postoperative opioid consumption, side effects such as nausea, vomiting, itching and block related complications will be recorded."
15845173|NCT04081935|Device|Virtual Reality|virtual reality (VR) as a distracting intervention could reduce pain and fear during an IV placement for school-age children in the emergent department.
15845174|NCT04081922|Procedure|Erector spinae plane block|Using ultrasound, place the needle in the erector spinae fascia plane at T7-8 level. Then, 0.25% ropivacaine 0.5 ml is injected to confirm the needle location. After checking the location, 0.25% ropivacaine 0.5 ml/kg is administered. This procedure is repeated at contralateral side.
15845175|NCT04081909|Drug|Fentanyl，Remifentanil|Patients in OBA ,anesthesia induction will receive fentanyl 2ug/kg ,propofol 1% 2-3mg/kg, rocuronium 0.6-1mg/kg. Anesthesia maintenance with 1.5-2% sevoflurane, propofol 1% 3-6mg/kg/hr , remifentanil of 0.1- 0.2ug/ kg/ min.
15845176|NCT04081909|Drug|Ketamine,Dexmedetomidine|Patients in OFA,anesthesia induction will receive ketamine 1 mg/kg ,propofol 1% 2-3mg/kg, rocuronium 0.6-1mg/kg. Anesthesia maintenance with 1.5-2% sevoflurane, propofol 1% 3-6mg/kg/hr , dexmedetomidine of 0.4-0.8ug/ kg/ hr.
15845177|NCT04081896|Other|Exercise|"Exercise prescribed to participants includes personalized spine-specific strengthening exercises targeting the core musculature (i.e. Multifidus, Erector Spinae, Transversus Abdominus, Obliques, and Rectus Abdominus). The in-clinic exercise program recommends a minimum of 20 visits at 2 visits/week, with a goal of 24 total visits over a 12-week period. Exercise is progressed by 5-10% of their exercise load once they are able to do >20 repetitions. If they are able to reach >10 repetitions but <20 repetitions their exercise load remains the same. If they are unable to reach 10 repetitions their exercise load is decreased 5-10% at their next visit. For each visit, pain and medication usage will be documented, and the strengthening protocol will be progressed as described above.
~The online exercise program includes non-machine based home exercises targeting the same muscles of interest, and are personalized to each participant based on their home resources and comfort level."
15845178|NCT04081883|Other|Biosensor algorithm|The biosensor DIABLO responses will be compared to the measurements of standard CGMS, using blood glucose measures every 10 minutes by taking interstitial fluid from Diabetes Type 1 (DT1) patients with an internal or external insulin pump.
15845179|NCT04081870|Diagnostic Test|3D power doppler US|Three D power Doppler US was done for every woman at the day after HCG administration. Ovum pick up was done after 35 hours following HCG administration.
15845180|NCT04081857|Drug|HGP1810|HGP1810: Vildagliptin/Metformin
15845181|NCT04081857|Drug|HCP1704|HCP1704: Vildagliptin/Metformin
15845182|NCT04081844|Drug|HCP1306|Ezetimibe 10mg / Rosuvastatin 20mg (Rosuzet)
15845183|NCT04081844|Drug|HGP0904|Amlodipine 5mg(Norvasc)
15845184|NCT04081844|Drug|HGP0608|Losartan 100mg(Cozaar)
15845185|NCT04081831|Drug|Acetylsalicylic Acid (Aspirin, BAYE4465)|Follow clinical administration
15845186|NCT04081818|Other|Nutritious Mushrooms|The Intervention group will consume antioxidant rich and Vitamin D2-enhanced mushrooms as a snack daily for 3 months.
15845222|NCT04081506|Other|Individualized perfusion targets|Targeting +/-5mmHg of the optimal mean arterial pressure
15845223|NCT04081493|Other|Low-load blood flow restricted exercise|"Leg press and knee extension exercise 3 times per week for 8 weeks. Repetition scheme: 30-15-15-until exhaustion interspaced by 30 sec rest. 5 min free-flow rest between exercises"
15845188|NCT04081805|Procedure|Micro Ablative Radiofrequency|Use of Linly™ equipment to perform ambulatory intravaginal and vulvar application of fractionated microablative radiofrequency, to postmenopausal genitourinary syndrome. The patient will be in gynecological position, after remove of vaginal secretion, with gauze and under topic anesthesia, the radiofrequency will be applied, according to the protocol of the manufactured
15845189|NCT04081805|Drug|Promestriene|The patient will perform self application of this vaginal promestriene daily for 2 weeks and after that the applications will occur twice a week.
15845190|NCT04081792|Procedure|Antibiotic therapy|Postoperative randomizations regarding the duration of systemic antibiotics
15845191|NCT04081779|Other|Survivorship Care Plan|Receive patient-generated SCP
15845192|NCT04081779|Other|Educational Intervention|Receive telephone-based educational counseling session
15845193|NCT04081779|Other|Questionnaire Administration|Ancillary studies
15845194|NCT04081766|Behavioral|SUGAR Handshake|"An interactive patient counselling session delivered by a pharmacist which mainly focuses on medication-related instructions towards preventing hypoglycaemia in addition to recommendations about hypoglycemia early recognition, causes, and treatment. The SUGAR Handshake is individualised according to shared decision making and each participant's characteristics.
~Components of the SUGAR Handshake intervention will be covered under five main domains:
~Signs and symptoms of hypoglycemia.
~Understanding the underlying causes of hypoglycaemia such as misuse of anti-diabetic medications.
~Good glycaemic control and self-monitoring, which mainly includes instructions on handling the anti-diabetic medications.
~Acknowledgement by the patient
~Recap and summary
~The pictogram contains the main recommendations for easy recall by the participant. Moreover, the intervention will be reinforced by a phone call at week 6 of the inclusion visit."
15845195|NCT04081753|Device|Remote monitoring of temperature|The patient will be set up with a remote monitoring device for temperature recording and the temperature will monitored remotely
15845196|NCT04081727|Device|Zip-stitch(TM)|The Zip-stitch™ system is comprised of a handheld applicator and clip loading tool compatible with standard 10mm trocars and laparoscopic surgical equipment as well as a set of bio-absorbable poly p dioxanone (PDO) clips. This system was developed specifically for closure of the vaginal cuff during laparoscopic hysterectomy as a replacement for traditionally cumbersome laparoscopic suture techniques.
15845197|NCT04081714|Drug|CNM-Au8|CNM-Au8 is a dark red/purple-colored liquid formulation consisting of a stable suspension of faceted clean surfaced elemental gold nanocrystals in buffered USP water with a concentration of up to 0.5 mg/mL of gold. The formulation is buffered by sodium bicarbonate present at a concentration of 0.546 mg/mL. There are no other excipients. The drug product is formulated to be taken orally and will be provided in single dose HDPE containers.
15845198|NCT04081701|Diagnostic Test|Ga68-DOTATATE-PET/MRI|"In patients with meningioma who are undergoing surgical planning, subjects will undergo a PET scan at the time of their pretreatment or preoperative standard of care MRI exam, prior to surgery performed for research purposes. Instead of the standard of care MRI exam, subjects will undergo a dedicated hybrid Gallium-68-DOTATATE PET/MRI.There will be up to two follow-up with Ga68-DOTATATE PET/MRI scans performed as standard of care.
~In patients with SSTR-positive CNS tumors that are non-meningioma, MRI is often performed to assess extent of disease. Subjects may be asked to undergo a PET scan for research purposes at the time of their standard of care MRI. Instead of the standard of care MRI exam, they may be asked to undergo a dedicated hybrid Gallium-68-DOTATATE PET/MRI."
15845199|NCT04081688|Drug|Atezolizumab 1200 MG in 20 ML Injection|Given IV every 3 weeks (cycle is 21 days)
15845200|NCT04081688|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT between cycle 1 and cycle 2 (each cycle is 21 days)
15845201|NCT04081688|Drug|Varlilumab 3 mg/kg|Given IV every 3 weeks (cycle is 21 days)
15845202|NCT04081675|Device|Ankle Foot Orthosis (AFO)|Thermoplastic orthotic device spanning the calf, ankle and foot.
15845203|NCT04081662|Behavioral|compACT Intervention|"The mobile intervention in this study consists of two components: 1) self-monitoring and 2) an ACT-based microintervention.
~Self-monitoring: twice daily, participants will complete self-reports of distress, depressive symptoms, and activity through the mobile app Lorevimo.
~Microintervention: The microintervention will consist of one of 84 prompts that aim to target one of 6 processes targeted in ACT (contacting the present moment, defusion, acceptance, self-as-context, values, and committed action). At each time-point, participants have a 50% chance of receiving a microintervention question along with the daily self-monitoring assessments."
15845204|NCT04081636|Procedure|Systematic Transrectal biopsy (TR-Bx)|Through the rectum
15845205|NCT04081636|Procedure|Targeted Transrectal biopsy (TR-Bx)|Through the rectum
15845206|NCT04081636|Procedure|Systematic Transperineal biopsy (TP-Bx)|Through the perineal skin
15845207|NCT04081636|Procedure|Targeted Transperineal biopsy (TP-Bx)|Through the perineal skin
15845208|NCT04081623|Device|Raydiant Oximetry Sensing System|The investigational device is used to record fetal pulse signals.
15845209|NCT04081610|Drug|lagricel ofteno multidose|"Dosage: 1 drop 4 times a day per 7 days, both eyes
~Route of administration: Ophthalmic"
15845210|NCT04081610|Drug|lagricel ofteno single dose|"Dosage: 1 drop 4 times a day per 7 days, both eyes
~Route of administration: Ophthalmic"
15845211|NCT04081597|Drug|Star-101|Administered orally
15845212|NCT04081597|Drug|Placebo|Administered orally
15845213|NCT04081584|Device|ISS Device|The ISS Device (commercial and prototype) is used to measure tissue light scattering.
15845214|NCT04081558|Device|Electronic patient reported outcomes tool|Electronic patient reported outcomes
15845215|NCT04081545|Drug|Opioid Anesthetics|see arm/group description
15845216|NCT04081545|Drug|Non Opioid Analgesics|see arm/group description
15845217|NCT04081532|Procedure|surgical removal of superficial peritoneal endometriosis|In the active comparator group patients will have endometriosis lesions removed by ablation or excision. Patients randomised to no surgical treatment arm will not have lesions removed and will only be given diagnosis on whether endometriosis was found or not.
15845218|NCT04081519|Device|active rTMS over DLPFC|15 sessions of active rTMS over DLPFC
15845219|NCT04081519|Device|Add-on active rTMS over DLPFC|15 additional sessions of active rTMS over DLPFC
15845220|NCT04081519|Device|Add-on active rTMS over LPC|15 additional sessions of active rTMS over LPC
15845221|NCT04081519|Device|Add-on sham rTMS|15 additional sessions of sham rTMS over DLPFC or LPC
15845227|NCT04081454|Behavioral|Education|The parent program includes psychoeducation regarding pain in the context of adolescent development, didactic and vignette-based practice of an adaptive parent communication response style (i.e., reflective listening), and concrete tools for setting up behavior plans to scaffold an adolescent's return to function for school, sleep, daily activities, and exercise. All parents are provided with a take-home workbook inclusive of neuroscience and psychoeducational materials as well as a list of resources to further solidify the information they learned.
15845228|NCT04081441|Device|Inyenyeri clean cookstove and fuel system|The Inyenyeri cooking systems includes a tier 4 clean cooking system with biomass pellets that are purchased through the unconditional cash transfer program in the refugee camp
15845229|NCT04081441|Behavioral|I-ACT (Individual, Agency-Centered Training) workshop|The I-ACT (Individual, Agency-Centered Training) empowerment workshop consists of behavioral exercises drawn primarily from positive psychology, that provide the tools to foster a growth mindset by allowing participants to understand the link between their thoughts, beliefs, and past actions to their future actions. Conducted in a workshop setting, this locally adapted version of the I-ACT curriculum consists of two days for women and a 1 day workshop for their male partners (as applicable)
15845230|NCT04081428|Radiation|Stereotactic Body Radiotherapy|Daily collection of breath and blood before and after each of the 5 radiotherapy treatment sessions. Before and after daily cone beam CT image collection
15845231|NCT04081402|Biological|HU-014|Hutox Inj(Clostridium botulinum type A)
15845232|NCT04081402|Biological|Botox Inj|Botox Inj(Clostridium botulinum type A)
15845233|NCT04081389|Drug|Celecoxib|Given PO
15845234|NCT04081389|Drug|Cyclophosphamide|Given IV
15845235|NCT04081389|Drug|Doxorubicin|Given IV
15845236|NCT04081389|Drug|Doxorubicin Hydrochloride|Given IV
15845237|NCT04081389|Drug|Paclitaxel|Given IV
15845238|NCT04081389|Biological|Recombinant Interferon Alfa-2b|Given IV
15845239|NCT04081389|Drug|Rintatolimod|Given IV
15845240|NCT04081376|Drug|Hydromorphone Hydrochloride|4 mg of hydromorphone hydrochloride (equivalent to 3.56 mg of hydromorphone) administered orally in a single dose.
15845241|NCT04081363|Drug|Centanafadine|Extended-release capsule
15845242|NCT04081350|Drug|LY3471851|Administered SC
15845243|NCT04081350|Drug|Placebo|Administered SC
15845244|NCT04081337|Drug|Tirzepatide|Administered SC
15845245|NCT04081337|Drug|Placebo|Administered SC
15845246|NCT04081324|Drug|Lasmiditan|Administered orally
15845247|NCT04081324|Drug|Placebo|Administered orally
15845248|NCT04081311|Device|comparing interdental floss to water flosser around dental implants|to determine the effectiveness in reducing the bleeding on probing (BOP) index around dental implants
15845249|NCT04081298|Behavioral|Health Education|Attend nutrition and PA classes, and cooking sessions
15845250|NCT04081298|Other|Physical Activity|Participate in physical activities
15845251|NCT04081298|Other|Health Promotion and Education: Text Messages|Receive motivational text messages
15845252|NCT04081298|Other|Health Promotion and Education: Web Site|Given access to nutrition website
15845253|NCT04081298|Other|Medical Device Usage and Evaluation: FitBit|Wear a FitBit
15845254|NCT04081298|Other|Medical Device Usage and Evaluation: Actigraph|Wear an actigraph
15845255|NCT04081298|Other|Quality-of-Life Assessment|Ancillary studies
15845256|NCT04081298|Other|Questionnaire Administration|Ancillary studies
15845257|NCT04081272|Drug|Sodium Chromate Cr51|Sodium Chromate Cr 51 will be used to perform a red blood cell recovered study 24 hours post-transfusion.
15845258|NCT04081259|Drug|LY3214996|LY3214996 is an extracellular signal-regulated kinase (ERK) inhibitor that is being developed as a treatment for patients with advanced cancer. ERK inhibitors stop the signal that a cancer cell receives telling it to grow.
15845259|NCT04081246|Device|Bipolar transurethral modified en bloc resection of bladder tumour|Olympus TURis Bipolar HF-resection electrode (Model: WA22306D)
15845260|NCT04081233|Procedure|surgical stabilization|Surgical procedure utilizing any commercially available internal rib fixation system
15845261|NCT04081233|Procedure|Usual care|Usual care typically consists of breathing exercises and pain control,often including opioids
15845262|NCT04081220|Drug|IMG-7289|Single starting dose with individualized dose titrations throughout
15845263|NCT04081207|Behavioral|AAC for Language Recovery (AAC-LaRc)|iPads will be programmed with a personalized communication application (app) and a structured 4-step intervention will be employed to instruct patients how to cue themselves during anomic events via pictures, text, or speak buttons.
15845264|NCT04081181|Procedure|Microwave ablation|CT_guided Microwave ablation is a minimally invasive technique that kill the insitu lung cancer cells, produce large volumes of cellular necrosis with reduced procedure time .According to the preoperative CT image of the patient , we will determine the focal position of the lesion ,it's size and it's relationship with adjacent organs to choose the optimal puncture point , puncture path and proper microwave antenna and to set the power and time of ablation.Then under the guidance of CT , the tip of antenna will be sent into the focus by puncture with ablation power of 60_80 W .according to tumor size , the ablation time will be determined.Needle track coagulation will be done to prevent seeding of malignant cells. After ablation a CT scan will be done immediately to observe the size ,shape and relation to nearby organ of the lesion and to determine if there is pneumothorax
15845265|NCT04081168|Device|Stereotactic Body Radiotherapy|Patients will undergo Stereotactic Body Radiotherapy (SBRT)
15845266|NCT04081168|Device|Microwave Ablation|Patients will undergo Microwave Ablation (MWA)
15845267|NCT04081116|Other|Symmetric settings (high pressures/fast rate)|Describes settings on the MI-E device
15845268|NCT04081116|Other|Asymmetric settings (Pi<Pe/Ti>Te)|Lower insufflation pressures at longer times
15845269|NCT04081116|Other|Preinclusion settings|Settings in use at start of study
15845270|NCT04081103|Drug|NEXAGON High Dose Concentration|Applied under a bandage contact lens and to the fornices of the eye.
15845271|NCT04081103|Drug|NEXAGON Low Dose Concentration|Applied under a bandage contact lens and to the fornices of the eye.
15845272|NCT04081103|Drug|NEXAGON Vehicle|Applied under a bandage contact lens and to the fornices of the eye.
15845273|NCT04081090|Behavioral|Brain HQ Cognitive Modules|Online personalized cognitive therapy modules to address and improve neuroplasticity.
15845274|NCT04081077|Drug|Bedaquiline|Bedaquiline is a diarylquinoline class antimicrobial which blocks the proton pump for ATP synthase of mycobacteria. This in turn blocks the ATP production required for cellular energy production and leading to cell death.
15845275|NCT04081077|Drug|Pretomanid|Pretomanid is an nitroimidazole class antimicrobial which interferes with cell wall biosynthesis in mycobacteria. It may have other mechanisms of action as well in non-replicating mycobacteria.
15845276|NCT04081077|Drug|Moxifloxacin|Moxifloxacin is an 8-methoxyquinolone class antimicrobial that is a potent inhibitor of DNA gyrase and topoisomerase IV in bacteria
15845277|NCT04081077|Drug|Linezolid|Linezolid, an oxazolidinone class antimicrobial which works by inhibiting ribosomal protein synthesis. It is approved for Gram-positive bacterial infections, and is increasingly being used for drug resistant TB disease.
15845278|NCT04081077|Drug|Clofazimine|Clofazimine (Cfz) is a lipophilic riminophenazine licensed for treatment of leprosy. Its mechanism(s) of action remains unclear, but existing evidence suggests production of reactive oxygen species within Mycobacterium tuberculosis is one mechanism.
15845279|NCT04081064|Behavioral|10-week exercise programme based on aerobic interval and resistance training|The intervention will take place over 10 weeks. Participants will complete three sessions per week; each sessions will be scheduled at least 24 hours apart. Two sessions per week will consist of aerobic interval exercise and resistance training, and one session per week will consist of aerobic interval exercise only.
15845280|NCT04081051|Other|diagnostic algorithm+Point of care rapid diagnostic tests+ Behavior change ( assessed together as a single package of interventions)|Diagnostic algorithm utilizing pathogen specific and non-pathogen specific point of care, rapid diagnostic tests, behavioral change intervention for healthcare workers
15845281|NCT04081038|Diagnostic Test|Brush biopsy|Brush biopsy will be performed by dentists and dental hygienists
15845282|NCT04081025|Other|EpiWux|A cross-sectional and longitudinal study including a questionnaire and a clinical examination
15845283|NCT04081012|Drug|N-acetyl cysteine|Patients will receive a 4-dose schedule of 600 mg diluted in 50 ml of 0.9% saline intravenously every 12 hours starting 24 hours before pulmonary endarterectomy or balloon pulmonary angioplasty.
15845284|NCT04081012|Drug|Placebo|The placebo group will receive a similar volume of normal saline as a placebo at the same time intervals.
15845285|NCT04080999|Device|r-TMS|The interventions have a total administration time of 75 minutes per day.For TMS stimulation, the coil will be positioned tangentially on the target area. Each r-TMS session will last 15 minutes and will be administered every other day (e.g. Monday-Wednesday-Friday, Monday-Wednesday-Friday, Monday). The visual scanning treatment involves the presence of a therapist, who administers various visual scanning tasks, used to increase patient's awareness and to teach strategies to improve spatial exploration abilities (Pizzamiglio et al.,1992).Trainings include three increasing levels of difficulty (9 possible combinations). Each level of difficulty will be exercised until the patient reaches a level of accuracy of 75%. The CCT will be carried out in 50 minutes sessions for 5 days a week within 15 days (11 sessions in total). On the days when the r-TMS is also administered, the administration of the CCT will immediately follow the brain stimulation.
15845286|NCT04080999|Device|SHAM|Device: SHAM Stimulation and Visual Scanning training. In the control group, the coil of the r-TMS will be positioned at 90° on the target area, thus no specific cortical modulation will be implemented (SHAM stimulation). For the SHAM group, the CCT protocol will be administered with the same modalities and time frame as detailed for the intervention group.
15845287|NCT04080986|Procedure|Double Sequential Defibrillation|Defibrillation using pad placement in anterior-posterior position
15845288|NCT04080986|Procedure|Vector Change Defibrillation|Defibrillation using two defibrillators, one with pad placement in anterior-posterior position and the other with pad placement in anterior-anterior position delivering two rapid sequential shocks.
15845289|NCT04080973|Diagnostic Test|CT scan|non contrast spiral CT of the urinary tract including the bony structures of the spine and pelvis
15845290|NCT04080973|Diagnostic Test|24 hour urine collection|24 hours collection of urine and measurement of the concentration of calcium, phosphorous, uric acid, oxalate and citrate
15845291|NCT04080960|Behavioral|Lifestyle modification education|Lifestyle modification education and goal setting
15845292|NCT04080947|Drug|Control group|patients received matching-image placebo once daily at bedtime for 12 weeks.
15845293|NCT04080947|Drug|Montelukast group|patients received montelukast (10-mg chewable tablet) once daily at bedtime for 12 weeks.
15845294|NCT04080934|Behavioral|Swimming|Patients will participate in 8 weeks of the swimming program, which involves three weekly swimming sessions of 30 minutes minimum.
15845295|NCT04080921|Combination Product|Stem cell transplantation|Transplantation of Autologous Bone Marrow Mononuclear Cells
15845296|NCT04080908|Drug|Ferumoxytol injection|Two doses of ferumoxytol injection will be administered intravenously 3-8 days apart.
15845297|NCT04080895|Drug|Artemether-lumefantrine|Artemether-lumefantrine on Day 0, 1 and 2 Washout period: more than 6 weeks
15845298|NCT04080895|Drug|Amodiaquine|Amodiaquine on Day 0, 1 and 2 Washout period: more than 6 weeks
15845299|NCT04080895|Drug|Artemether-lumefantrine|Artemether-lumefantrine on Day 0, 1 and 2 Washout period: more than 6 weeks
15845300|NCT04080895|Drug|Artemether-lumefantrine + Amodiaquine|Artemether-lumefantrine + Amodiaquine on Day 0, 1 and 2
15845301|NCT04080882|Biological|AbobotulinumtoxinA dose 1|Treatment of platysmal bands
15845302|NCT04080882|Other|Placebo|Treatment of platysmal bands
15845303|NCT04080882|Biological|AbobotulinumtoxinA dose 2|Treatment of platysmal bands
15845304|NCT04080882|Biological|AbobotulinumtoxinA dose 3|Treatment of platysmal bands
15845305|NCT04080869|Drug|retinyl palmitate|topical retinyl palmitate loaded ethosomes
15845306|NCT04080869|Drug|Tretinoin|topical tretinoin
15845307|NCT04080843|Drug|Anlotinib Hydrochloride|Anlotinib Hydrochloride is a capsule in the form of 8 mg ,10 mg and 12 mg, orally, once daily, 2 weeks on/1 week off.
15845308|NCT04080843|Drug|Capecitabine|Capecitabine is a capsule in the form of 500 mg, orally, 850 mg/m2, twice daily, 2 weeks on/1 week off.
15845309|NCT04080843|Drug|Oxaliplatin|Oxaliplatin 130 mg/m2,D1
15845310|NCT04080817|Device|Neolexon|Application (Neolexon) on Tablet. Same frequency & intensity as in the other interventions
15845312|NCT04080817|Other|Self training|Same frequency & intensity as in the other interventions
15845316|NCT04080791|Device|Virtual Reality (VR) System|The participants will undergo daily 30-minute sessions for 8 days of Virtual Reality (VR) with a VR system using commercially available default programs in addition to traditional intensive therapy regimen provided during inpatient rehab.
15845317|NCT04080791|Procedure|Standard of care|Control group participants will receive the traditional daily 30-minute intensive therapy regimen provided during acute inpatient rehabilitation stroke treatment protocol.
15845318|NCT04080778|Device|MST|MST will be performed with the MagPro XP (120 V) device under anesthesia 2-3 times a week up to 15 sessions.Treatment is performed by magnetic stimulation of both hemispheres inducing a focal stimulation above vertex, using a serial of pulse trains with a frequency of at least 25 Hz but up to 100 Hz for 4-6 s (up to 10 s), which is sufficient to induce a tonic clonic seizure.
15845319|NCT04080778|Device|ECT|ECT will be performed with MECTA 5000Q, 4th generation ECT devices provided by MECTA Corporation under anesthesia 2-3 times a week up to 15 sessions.For initial procedure Seizure Threshold (ST) will be estimated by empiric titration in the first session of each participant. ST will be then determined as by the manufacturer of ECT Device by the titration schedule for the initial titration session.The subsequent treatment sessions were dosed at 6 times the charge of the seizure threshold.
15845320|NCT04080765|Behavioral|HIV-ASSIST|HIV-ASSIST is an online interactive patient-based tool that allows for individualized HIV treatment recommendations through the synthesis of patient-specific factors with existing guidelines and evidence.
15845321|NCT04080765|Behavioral|DHHS guidelines|This is the Department of Health and Human Services HIV/AIDS Treatment Guidelines.
15845322|NCT04080752|Drug|JNJ-61393215|JNJ-61393215 will be administrated orally.
15845323|NCT04080752|Drug|Placebo|Matching placebo will be administered orally.
15845324|NCT04080739|Drug|ropivicaine 0.2%|2-8 cc/hr of 0.2% ropivicaine given as a regional block via US-guided ipsilateral sciatic nerve block for fibula free flap patients or US-guided infraclavicular brachial plexus nerve block for forearm free flap patients.
15845325|NCT04080726|Drug|HIP1601|Oral esomeprazole
15845326|NCT04080726|Drug|HGP1705|Oral Nexium Tab
15845327|NCT04080726|Drug|HIP1601 Placebo|Oral Placebo
15845328|NCT04080726|Drug|HGP1705 Placebo|Oral Placebo
15845329|NCT04080713|Drug|Budesonide|Budesonide 9 mg prolonged release tablet
15845330|NCT04080700|Procedure|Distal radial approach|Operator puncture the distal radial artery with open needle or venipuncture catheter needle for coronary angiography and percutaneous coronary intervention.
15845331|NCT04080687|Device|Ankle-foot orthosis|Ankle-foot orthosis of any type (unilateral or bilateral, standard or carbon fiber, for support or correction)
15845332|NCT04080674|Other|Feed-back controlled deep brain stimulation|Feed-back controlled deep brain stimulation
15845333|NCT04080661|Procedure|Venapuncture|Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of secukinumab.
15845334|NCT04080661|Other|Patient questionnaires|The study participants will complete the Dermatology Quality of Life (DLQI) and EQ-5D-5L questionnaire at each study visit.
15845335|NCT04080648|Procedure|Venapuncture|Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of guselkumab.
15845336|NCT04080648|Other|Patient questionnaires|The study participant will complete the dermatology quality of life index (DLQI) and EQ-5D-5L questionnaire at each study visit
15845337|NCT04080635|Procedure|Venapuncture|Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of brodalumab
15845338|NCT04080635|Other|Patient questionnaires|The study participant will complete the Dermatology Quality of Life Index (DLQI) and EQ5D5L
15845339|NCT04080622|Drug|Selenium|Selenium 300 µg/day (IV infusion)
15845340|NCT04080622|Drug|Placebos|NaCl 0,9% (IV infusion)
15845341|NCT04080609|Drug|Dorzagliatin|GKA currently under clinical development
15845342|NCT04080596|Drug|Dorzagliatin|GKA for T2DM currently under clinical development
15845343|NCT04080570|Other|Remote Visit|After an initial in-home visit, the physician will see home hospitalized patients by facilitated video.
15845344|NCT04080557|Other|Surgery|All patients treated electively for an abdominal aortic aneurysm (AAA) by open repair and patients undergoing emergency treatment for a ruptured AAA between 2013 and 2018.
15845345|NCT04080544|Drug|[18F]AV-1451|The subject will receive up to a target dose of 370 megabecquerel (MBq) as a single IV bolus of [18F]AV-1451.
15845346|NCT04080544|Procedure|Positron Emission Tomography|Approximately 80 minutes after injection subjects will be placed in the UTSW PET/CT scanner for a 20-minute brain scan.
15845347|NCT04080531|Biological|Pneumococcal 13-valent Conjugate Vaccine|Given IM
15845348|NCT04080531|Biological|Trivalent Influenza Vaccine|Given IM
15845349|NCT04080518|Drug|Dapagliflozin 10 MG [Forxiga]|24 Hour Urine Collection, Sodium (23Na) MRI and Magnetic Resonance (MR) spectroscopy scan, Blood collection for metabolomic and osmolyte analysis
15845350|NCT04080505|Drug|SSKI- Potassium Iodide|1g/mL, 2 drops orally 3 times a day for 7 days before surgery
15845351|NCT04080492|Other|QOL Survey|The Cardiac Quality of Life (QOL) survey measures health status in five domains: global, physical, emotional, social, and spiritual health. It also includes questions that assess self-efficacy and resilience. The global section asks about your overall quality of life and satisfaction with health. The physical section asks about symptoms and difficulty performing day-to-day tasks. The emotional section asks about depression, anxiety, and stress. The social section asks about social support and relationships. The spiritual section asks about the spiritual outlook on the burden of heart disease. Responses on a 5-level scale.
15845352|NCT04080479|Diagnostic Test|Quadriceps Muscle Layer Fitness|The QMLF examination will be performed in all study subjects, with both bolus and continuous enteral feeding.
15845353|NCT04080479|Diagnostic Test|Muscle Strength|All study subjects, with both bolus and continuous enteral feeding, will undergo measurement of the muscle strength using dynamometer.
15845354|NCT04080479|Diagnostic Test|Acute Physiology and Chronic Health Evaluation|All study subjects, with both bolus and continuous enteral feeding, will undergo the APACHE evaluation.
15845355|NCT04080479|Diagnostic Test|Sequential Organ Failure Assessment|All study subjects, with both bolus and continuous enteral feeding, will undergo the SOFA assessment.
15845356|NCT04080479|Diagnostic Test|Nutritional Risk Screening|All study subjects, with both bolus and continuous enteral feeding, will undergo the NSR screening.
15845357|NCT04080479|Diagnostic Test|Energy and Protein Intake|The amount of energy and protein supplied to the study subjects will be observed daily in all study subjects, with both bolus and continuous enteral feeding, the percentage of the planned daily intake will be analyzed.
15845358|NCT04080466|Radiation|Low-dose CT Scan|"Low dose computed tomography, also known as qCT, is sensitive to the mineral content within bone tissue, and can assess bone mineral density, a strong predictor of bone strength and stiffness, which can influence the health of the cartilage. Participants will undergo a low dose CT scan of both hips.
~Participants in the Cam Group will undergo this scan once as part of their standard of care. Participants in the Control Group will undergo this scan once as part of the study."
15845359|NCT04080466|Other|Blood/Urine Collection|"Collection of blood and urine allows the researchers to look for a biomarker in the blood and urine that might help to predict the evolution of disease/hip osteoarthritis. Identifying a marker in the blood and urine that could be used for early detection of individuals with cam deformity that are at-risk of hip degeneration could greatly improve patient care.
~Participants in the Cam Group will undergo the blood and urine collection twice; once before surgery and once 2-years post-operative. Participants in the Control Group will undergo a blood and urine collection once as part of the study."
15845360|NCT04080466|Other|Patient Reported Questionnaires|"The purpose of the questionnaires is to assess how much trouble the participant is having with their hip and how it affects their quality of life.
~Participants in the Cam Group will complete the questionnaires twice; once before surgery and once 2-years post-operative. Participants in the Control Group will complete the questionnaires once as part of the study."
15845361|NCT04080466|Radiation|EOS Scan|"The EOS® uses a new imaging technique that allows precise measurement of the hip and pelvis geometry and structure. This innovative x-ray technique exposes participants to 2-10 times less radiation than a routine x-ray and can capture multiple images at once.
~Participants in the Cam Group will undergo the EOS scan twice; once before surgery and once 2-years post-operative. Participants in the Control Group will undergo the scan once as part of the study."
15845362|NCT04080466|Radiation|PET-MRI|"Positron emission tomography combined with magnetic resonance imaging (PET-MRI) is a technology that allows physicians to examine bone and cartilage at the molecular level.
~Participants in the Cam Group will undergo the scan twice; once before surgery and once 2-years post-operative. Participants in the Control Group will undergo the scan once as part of the study."
15845363|NCT04080466|Other|Motion Analysis|"Motion analysis is the study of how joints move and which muscles fire during specific movements. In the lab, participants will be asked to perform movements that they might do during a typical day or when exercising.
~Participants in the Cam Group will undergo the Motion Analysis session twice; once before surgery and once 2-years post-operative. Participants in the Control Group will undergo the Motion Analysis session once as part of the study."
15845364|NCT04080466|Radiation|3T MRI|"Participants will undergo a 3-Tesla (3T) Magnetic Resonance Imaging (MRI) of both hips.
~Participants in the Cam Group will undergo this scan once as part of their standard of care. Participants in the Control Group will undergo this scan once as part of the study."
15845365|NCT04080453|Other|Septic shock|Plasma concentration in CD154, beta thromboglobulin, platelet factor 4, platelet microparticles, soluble CD62, RANTES, GRO-alpha, HMGB-1, monocyte Dnases signal, circulating free DNA and DNase1 and DNase1L3 activities will be studied and compared at inclusion (Day 0), Day 1 and Day 5.
15845366|NCT04080453|Other|Systemic Inflammatory Response Syndrome|Plasma concentration in CD154, beta thromboglobulin, platelet factor 4, platelet microparticles, soluble CD62, RANTES, GRO-alpha, HMGB-1, monocyte Dnases signal, circulating free DNA and DNase1 and DNase1L3 activities will be studied and compared at inclusion (Day 0), Day 1 and Day 5.
15845367|NCT04080440|Procedure|Extubation readiness clinical score|"After treatment of the acute neurological condition, elligibility for a spontaneous breathing trial will be assessed 2 times a day.
~In the intervention group, after a successful spontaneous breathing trial in unconscious patients, the score will be evaluated.
~If the score is >9, extubation has to be completed"
15845368|NCT04080440|Procedure|Standard of care|"After treatment of the acute neurological condition, elligibility for a spontaneous breathing trial will be assessed 2 times a day.
~In the control group, after a successful spontaneous breathing trial in unconscious patients, the extubation will be achieved according to the standard of care"
15845369|NCT04080427|Drug|Placebo capsule|Placebo is administered just prior to weekly exposure sessions by the oral route and contains only dextrose in opaque capsules.
15845370|NCT04080427|Drug|Dronabinol 7.5 milligram oral capsule|Dronabinol (7.5mg) is administered just prior to weekly exposure sessions by the oral route and is placed in an opaque capsule with dextrose filler.
15845371|NCT04080414|Behavioral|Home-based high-intensity interval training|Participants will be instructed to complete four, high-intensity interval training workouts per week at home, for the duration of the 12-week trial. Participants will be provided with detailed instructions on how to complete each workout.
15845372|NCT04080414|Behavioral|Home-based moderate-intensity continuous exercise|Participants will be instructed to complete five, moderate-intensity continuous exercise workouts per week at home, for the duration of the 12-week trial. Participants will be provided with detailed instructions on how to complete each workout.
15845373|NCT04080401|Device|Game-based rehabilitation exercise|4 games (exercises) on operated limb, for 3 sessions daily, until outpatient physiotherapy review visit.
15845374|NCT04080401|Other|Conventional brochures of rehabilitation exercise|4 exercises on operated limb, 30 reps each, for 3 sessions daily, until outpatient physiotherapy review visit.
15845375|NCT04080388|Diagnostic Test|Lung Impedance Device|The non-invasive lung impedance device enables assessment of the level of pulmonary congestion and can be an indication for additional anti-congestive treatment.
15845376|NCT04080388|Drug|Anti-congestive treatment|Continuation of in-hospital anti-congestive treatment
15845377|NCT04080375|Drug|Dinoprostone 3 mg|the patient will take one vaginal tablet of 3 mg dinoprostone 1 hour before surgery
15845378|NCT04080375|Drug|placebo|the patient will take one vaginal tablet of placebo 1 hour before surgery
15845379|NCT04080362|Device|MitralStitch|With transesophageal echocardiographic guidance,implanting ePTFE sutures as artificial neochordae or ege-to-ege repair using MitralStitch System
15845380|NCT04080349|Drug|Dinoprostone 3 mg|1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the study nurse 3 hours before IUD insertion.
15845381|NCT04080349|Drug|Misoprostol 200Mcg Tab|1 vaginal tablet of misoprostol (200 mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion.
15845382|NCT04080349|Drug|placebo|one tablet of placebo inserted by the study nurse 3 hours before IUD insertion
15845383|NCT04080336|Drug|Dinoprostone|1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the study nurse 3hours before IUD insertion.
15845384|NCT04080336|Drug|Misoprostol|1 vaginal tablet of misoprostol (200mcg) (Misotac®; Sigma Pharma, SAE, Egypt) inserted by the study nurse 3 hours before IUD insertion.
15845385|NCT04080336|Drug|placebo|one tablet of placebo inserted by the study nurse 3 hours before IUD insertion.
15845386|NCT04080323|Drug|Dinoprostone 3 mg|1 vaginal tablet of 3mg dinoprostone 60 minutes before surgery
15845387|NCT04080323|Drug|placebo|1 vaginal tablet of placebo 60 minutes before surgery
15845388|NCT04080310|Drug|Efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statin|"This study is a multicenter, randomized, open-label, parallel, phase IV trial. The study is planned to include 272 patients with clinical ASCVD requiring optimal statin therapy.
~After enrollment, subjects are randomized into two groups in a 1:1 manner. patients in combination therapy group(rosuvastation 10mg and ezetimibe 10mg daily) will be provided a fixed-dose single pill comibation and patients in the intensive statin group will receive rosuvastatin 20mg daily."
15845389|NCT04080297|Drug|oral capsule of Q-122|
15845390|NCT04080284|Drug|Niraparib|Study treatment will be administered orally Q day continuously. Up to three capsules of 100mg strength will be taken at each dose administration. Initiation dose will be defined per current FDA guidelines for Niraparib treatment in ovarian cancer. Dose interruption (no longer than 28 days) will be allowed. Dose reduction will be allowed based on treatment side effects. Dose reductions to 2 capsules daily (200mg) and subsequently to 1 capsule daily (100mg) will be allowed. No further dose reductions will be allowed. The timing of efficacy or safety evaluations should not be affected by dose interruptions or reductions.
15845391|NCT04080271|Device|18F-FDG PET/CT|18F-fludeoxyglucose positron emission tomography/computed tomography
15845392|NCT04080258|Other|Osteopathic manipulative therapy (OMTh)|"The Osteopathic Manipulative Therapy includes both evaluation and treatment. The evaluation is semi-structured, two osteopaths will assess the presence of somatic dysfunctions which have to include the hyoid-pharyngeal, laryngeal, temporo-mandibular and lingual areas.
~The therapy is based on the treatment of somatic dysfunctions with different approaches that include: the balanced ligamentous tension technique, the myofascial release, the visceral manipulation, and the balanced membranous tension technique. The OMTh lasts for 45 minutes of which 15 of evaluation and 30 of treatment."
15845393|NCT04080258|Other|Light Touch Therapy (LTT)|The Light Touch Therapy is a sham treatment consistent with the OMTh one during the phase of evaluation. The treatment retains the same areas used for osteopathic approach but avoids prolonged touch in any area of the body by moving the hands every few seconds and by flattening and softening the surface of the hands in order to minimize focal areas of force.
15845395|NCT04080232|Device|lung MRI|lung MRI (1.5T Siemens Aera) using the following sequences: 3D Fast gradient-echo pulse sequences with ultra-short echo time (UTE), acquisitions at end-inspiration breath hold, end-expiration breath hold, and free-breathing using an echonavigator positioned on the diaphragm, acquisitions using routine pulse sequences (SSFP, T2FSE) and the administration of oxygen during the MRI: O2 will be administered at 15L/min during 6 minutes.
15845396|NCT04080206|Drug|188-0551 Spray|Applied topically twice daily for two weeks
15845397|NCT04080206|Drug|RLD|Applied topically twice daily for two weeks
15845398|NCT04080193|Behavioral|Smartphone-based interventional trial|According to the SIRs the 12-week intervention will contain exercises from three out of six different key modules (e.g. self-efficacy, impulsivity). The remaining modules will be implemented as mini-modules during the end of the intervention phase. The study will be designed gender-sensitive instead of gender-dichotomous. This means that treatment contents will be individualized based on gender-related SIRs and not biological sex. Participants choose between two different styles of presentation for each module and the contents can be deepened within specific exercises.
15845399|NCT04080180|Behavioral|Contingency Management|Contingency management (CM) is a behavioral method that employs external rewards for target behavior. For this study, participants will receive gift cards for adhering to Medication-Assisted Treatment (attending physician visits and adhering to buprenorphine-naloxone as determined by urine toxicology panel) during their first four visits while randomized to this condition. Participants will draw a gift card from a fishbowl each visit they are adherent. Gift cards range from $25-$100.
15845400|NCT04080180|Behavioral|Brief Motivational Intervention plus Substance Free Activities Session|Brief Motivational Intervention plus Substance Free Activities Session (BMI+SFAS) is an intervention that uses Motivational Interviewing and Behavioral Economics strategies to increase the salience of delayed rewards by eliciting personal goals, developing opioid-free activities, and engaging in reward bundling and episodic future thinking. Participants will be offered a menu of substance free activities that has been developed in pilot work. Activities will be discussed, and participants will be asked to engage in selected activities as homework. Engagement in substance free activities will be assessed at each subsequent visit. Mindfulness components will also be included in the intervention.
15845420|NCT04079998|Device|Procellera®|Application of Procellera® dressing.
15845421|NCT04079998|Other|Standard of Care|Application of standard of care dressings as prescribed.
15845497|NCT04079322|Other|Meal|Participants will consume a meal containing a stable iron isotope following exercise or rest.
15845498|NCT04079309|Behavioral|Lavender/Orange|A diffuser containing 120 ml water and 0.3 ml lavender oil / 0.3 ml orange oil will be set into the parents' perioperative waiting rooms to mist at least 1 hour before the parent arrive.
15845401|NCT04080167|Behavioral|InCharge Health mobile application|"The InCharge Health app features include: Daily reminders; Ability to customize content of message and time of day when the message comes; Symptom tracker to monitor daily pain and mood; 7-day streak that tracks daily adherence; Graphing adherence against pain symptoms; Communication feature allowing the patient to connect to the clinic and a health partner; Link to discussion forum where communication to other patients can occur; Education bank that provides information about SCD and hydroxyurea. Participants can delay daily push notifications. If hospitalized, participants may stop notifications. A special feature of the app is to set up a health partner, who may be a person the participant may choose from his/her contact list and who will receive notifications if it had been <4 hours since not documenting the use of hydroxyurea. The app healthy partner will be encouraged to message the participant to remind him/her to take the medication."
15845402|NCT04080167|Behavioral|HU Toolbox mobile application|The HU Toolbox app includes algorithms for hydroxyurea use and is ready for immediate use on Apple and Android operating systems. In addition, it has the NHLBI guidelines adapted for pediatrics (guidelines/recommendations separated by age) and for adults (guidelines/ recommendations separated by organ system, laboratory, or physical exam finding). The HU Toolbox app includes the ability to search guidelines for key words and add notes. Algorithms are also included as PDF documents that can be printed out or emailed. Finally, a contact list of local SCD specialists and important contacts is included, so providers can easily contact SCD experts and expect an answer in 24 hours or less. The HU Toolbox app is easily updated with all data and resources stored on a cloud-based server that can provide instant up-to-date information to those using the app.
15845403|NCT04080154|Drug|Anlotinib|12mg orally (p.o.) every day (qd) for 2 weeks of every 3 week cycle (i.e. 2 weeks on, 1 week off)
15845404|NCT04080141|Diagnostic Test|Multiple psychometric questionnaire|At the time of first contact (T0) only women were subjected to Hamilton's rating scale for depression (HRSD or HAM-D), Hamilton's rating scale for anxiety (HRSA or HAM-A), Beck Depression Inventory (BDI-II). At the follow up after 1 year from the first examination (T1) they were subjected to a questionnaire with multiple psychometric tests for mother and her partner. The female version included Post-traumatic stress disorder checklist (PCL-5), Iowa Personality Disorder Screen (IPDS), Beck Depression Inventory (BDI-II), Connor-Davidson Resilience Scale 10 (CD-RISC 10) and Short-Form Questionnaire on childhood trauma (CTQ-SF). The male version included Post-traumatic stress disorder checklist (PCL-5), Iowa Personality Disorder Screen (IPDS), Connor-Davidson Resilience Scale 10 (CD-RISC 10) and Short-Form Questionnaire on childhood trauma (CTQ-SF).
15845405|NCT04080141|Procedure|Clinical psychiatric examination|At the time of first contact (T0) only women were subjected to psychiatric clinical examination
15845406|NCT04080128|Device|Contact lenses|Depending on the results of the BLINK Study either a single vision spherical contact lens or a multifocal contact lens.
15845407|NCT04080115|Behavioral|Attention Training Technique|ATT will be administered through a customized Expiwell smartphone application that will be downloaded onto participants' cell phones at the first laboratory session (T2). For the purposes of the proposed study, participants need to complete the intervention once a day, for the six days between their lab sessions; signals will begin the day after their T2 session and they will be notified up to a maximum of five times per day to complete their daily session. The ATT sessions are comprised of three phases. The first is a 5-minute phase during which the participant is instructed to attend to specific sounds in the recording and disregard other sounds. The subsequent 5-minute phase includes instructions to rapidly switch their attention between sounds in the recording. The final phase is a dual attention task lasting 2 minutes wherein the participant is instructed to pay attention to multiple sounds in the recording at once. In total, each session of ATT lasts 12 minutes.
15845408|NCT04080115|Behavioral|Sham intervention control condition|The sham control condition consists of the same 12 minutes of simultaneous sounds as the ATT technique, but will not include any verbal instruction, thus isolating the effects of intentional orientation of attention.
15845409|NCT04080102|Other|High Intensity Interval Training|Exercise
15845410|NCT04080102|Dietary Supplement|Essential Amino Acid|Oral ingestion of a powdered dietary supplement
15845411|NCT04080102|Other|High intensity interval training and essential amino acid supplement|Exercise and dietary supplement
15845412|NCT04080089|Combination Product|Surgical treatment, drug therapy, remote cognitive training|"Surgical treatment：Children with OSAHS who had surgical indications and informed consent from the parents underwent tonsillectomy and adenoidectomy.
~drug therapy：For children whose parents only agree to receive medical treatment, montelukast sodium tablets are given for 6 months to reduce the inflammatory response of adenoids, tonsils, etc.
~remote cognitive training:For children whose parents did not agree to undergo surgery or medication, the cognitive function was evaluated at the time of enrollment, and cognitive training was performed. Individualized training programs were developed according to the cognitive assessment system, and cognitive function was evaluated again after one course of treatment."
15845413|NCT04080076|Drug|Acthar 80 UNT/ML Injectable Solution|ACTHar 80 Units SQ 42 x Week
15845414|NCT04080076|Drug|Oral Tab Tacrolimus|Oral Tab Tacrolimus (1.0 mg PO BID) in combination with ACTHar 80 Units SQ 42 X week
15845415|NCT04080063|Other|adapted physical activity|The study begins with an evaluation of physical strenght and cognitive and psychometric assessment.Then, a personalized care will be offered in terms of adapted physical activity. The evaluation protocol will be performed again to measure the impact of physical activity three months after the first assessment.
15845416|NCT04080050|Drug|Single intravenous (IV) dose of human Low Density Lipoprotein Receptor (LDLR) Gene Therapy|No investigational product will be administered in this study. All participants have previously received a one-time intravenous infusion of RGX-501 in a separate clinical trial
15845417|NCT04080037|Other|Quality IQ Patient Simulations|"Online patient cases designed to simulate typical patients seen in a primary care practice. In each case, providers will answer multiple-choice questions about their preferred course of action to work-up, diagnose and treat patients in the primary care setting. After each question, providers will receive evidence-based feedback, including references, on the appropriateness of each of their care decisions. Feedback will be supported with relevant reference to evidence-based guidelines, with a specific focus on the CDC opioid guidelines.
~Cases will cover typical primary care patients presenting with acute and chronic pain, who may or may not be already taking opioid medication."
15845418|NCT04080024|Drug|SN132D|Novel manganese-based macromolecular MRI contrast agent
15845419|NCT04080011|Device|NP-PWD|Application of NP-PWD device.
15845422|NCT04079985|Other|Animal-assisted therapy|The sessions were held in the primary care centre, and had specific objectives agreed in advance by the research team. The sessions had the following schedule: Session 1, lower extremities in sitting position; Session 2, upper extremities in sitting position; Session 3, cervical spine in sitting position; Session 4, dorsal spine in sitting position; Session 5, lumbar spine in sitting position; Session 6, Static Standing and Upper Extremities; Session 7, Static Standing; Sessions 8, 9, 10 and 11, Dynamic Standing; and Session 12, Safety Reinforcement.
15845423|NCT04079972|Behavioral|personalized lifestyle intervention|Based on genotype of SNPs potentially relevant to weight control, tailored lifestyle guidance to facilitate weight loss will be provided.
15845424|NCT04079972|Behavioral|general lifestyle intervention|Regardless of individuals' genetic make-up, general lifestyle guidance to facilitate weight loss will be provided.
15845425|NCT04079959|Procedure|endometrial biopsy|. Endometrial samples are obtained using a biopsy catheter as follows: the Pipette is inserted through the cervical os and advanced gently until resistance is felt. The inner piton of the device is then withdrawn to create suction, and the endometrial sample is obtained by moving the pipette up and down approximately 2-3 cm within the uterine cavity. The device is rotated 360° to ensure adequate coverage of the area.
15845426|NCT04079946|Procedure|Total Mesocolic Excision with Central Vessel Ligation|sharp dissection of the anatomical layers and the dissection of the visceral plane from the parietal one . In addition a central division of the feeding arteries at their origins is performed at the level of superior mesenteric artery for tumors of the right colon and at the level of inferior mesenteric artery or the aorta for tumors of the left colon .this allows for removal of the maximum number of lymph nodes possible.
15845427|NCT04079946|Procedure|conventional surgery of cancer colon|removal of the tumor with no ligation of the vessel centrally or removal of the whole mesocolon
15845428|NCT04079933|Other|Oral tobacco-derived nicotine product (OTDN)|
15845429|NCT04079907|Dietary Supplement|Ketone|This intervention will take their respective supplement for 14 days, then will be followed for up to 1 year during routine clinic visits.
15845430|NCT04079907|Dietary Supplement|Placebo|This intervention will take their respective supplement for 14 days, then will be followed for up to 1 year during routine clinic visits.
15845431|NCT04079894|Other|Standard Movement Protocol|Participant walking, cycling and sitting according to a pre-specified protocol.
15845432|NCT04079894|Device|Accerelerometer Monitoring|7 days of accelerometer monitoring in participants home-environment.
15845433|NCT04079881|Drug|Insulin|to give pre-prandial and post-prandial insulin (will use patient insulin dose patient use at home) to patients with T1D and evaluate the response of post-prandial glucagon and post-prandial hyperglycemia.
15845434|NCT04079868|Behavioral|Bone Health Service Model|Patients in PACTs randomized to the BHS model will have osteoporosis screening, education, and follow-up handled centrally by the bone health team.
15845435|NCT04079855|Other|Diet composition 1|A diet with a specified macronutrient composition different from arms 2, 3, and 4.
15845436|NCT04079855|Other|Diet composition 2|A diet with a specified macronutrient composition different from arms 1, 3, and 4.
15845437|NCT04079855|Other|Diet composition 3|A diet with a specified macronutrient composition different from arms 1, 2, and 4.
15845438|NCT04079855|Other|Diet composition 4|A diet with a specified macronutrient composition different from arms 1, 2, and 3 based on the current information about the US macronutrient composition.
15845439|NCT04079829|Other|Observational retrospective cohort to describe data validity; and Data reliability; and Completeness of the data|No interventions
15845440|NCT04079803|Drug|Placebo oral tablet|Oral placebo tablet
15845441|NCT04079803|Drug|Simufilam 100 mg tablet|Simufilam 100 mg oral tablet
15845442|NCT04079803|Drug|Simufilam 50 mg oral tablet|Simufilam 50 mg oral tablet
15845443|NCT04079790|Drug|Gepotidacin|Tablets containing gepotidacin mesylate with a unit dose of 750 mg will be administered orally with 240 milliliter (mL) of water.
15845444|NCT04079790|Drug|Placebo|Tablets containing unit dose of placebo matching of gepotidacin will be administered orally with 240 mL of water.
15845445|NCT04079777|Drug|Clinical treatment|Liquid Resuscitation, Anti-infection
15845446|NCT04079751|Procedure|Neutral Mechanical Alignment|Hip-knee-ankle angle of 180° ± 3°.
15845447|NCT04079751|Procedure|Anatomical Alignment|Restoring a patient's pre-diseased limb alignment
15845448|NCT04079738|Drug|TAK-659|TAK-659
15845449|NCT04079738|Drug|Ixazomib|Ixazomib
15845450|NCT04079725|Procedure|Combined trabeculotomy-trabeculectomy with mitomycin c|Combined trabeculotomy-trabeculectomy with mitomycin C Will be done in all cases then histopathological examination of iris tissue to detect the nature of the disease
15845454|NCT04079699|Diagnostic Test|Liquid Biopsy|Measuring biomarkers in blood and urine samples
15845455|NCT04079699|Diagnostic Test|Standard biopsy|Histological examination of tissue biopsies
15845456|NCT04079686|Drug|Cephazolin|Patients undergoing reduction mammaplasty will receive 1g of cephazolin intravenously anesthetic induction and postoperatively every 6 hours, for 24 hours.
15845457|NCT04079686|Other|Sterile saline|Patients undergoing reduction mammaplasty will receive 1g of cephazolin intravenously anesthetic induction and intravenous sterile saline postoperatively, every 6 hours, for 24 hours.
15845460|NCT04079660|Diagnostic Test|Capillary blood glucose blood draw|Capillary blood glucose (CBG), HbA1c, fructosamine, albumin, BUN, and creatinine values will be obtained from a blood draw as a standard of care
15845461|NCT04079647|Drug|Immunotherapy|Patients receive immunotherapy for cancer treatment
15845462|NCT04079634|Device|Esophageal warming|Use of EnsoETM for esophageal warming to limit injury during atrial fibrillation ablation procedure
15845463|NCT04079634|Device|Control|Standard temperature probe monitoring
15845464|NCT04079621|Drug|primaquine|Primaquine regimen over 7 days (0.5mg/kg/day for 7 days)
15845465|NCT04079608|Behavioral|FLASH curriculum|High School FLASH is a 15-session comprehensive sexual health curriculum designed for classroom settings in grades 9 to 12. The basis of High School FLASH is a public health approach to behavior change. The primary strategy used in the FLASH curriculum for preventing teen pregnancy, sexually transmitted diseases (STDs), and sexual violence is to address student behaviors and attitudes. To this end, FLASH uses a harm reduction and behavior change framework, implements best practices as outlined in the research on effective programs, addresses risk and protective factors for program goals, and rests on the theory of planned behavior. The instructional approach of High School FLASH employs key concepts in every lesson, which enables teachers to hone in on the risk and protective factors outlined in the curriculum logic model.
15845466|NCT04079608|Behavioral|Sexual Health Education for Adolescents|Sexual Health Education for Adolescents is a five-session knowledge-based sexual health curriculum designed for classroom settings. The lessons cover the reproductive system, pregnancy, birth control, abstinence, human immunodeficiency virus (HIV) and other sexually transmitted diseases (STDs), and healthy relationships. The goal of the curriculum is to increase student knowledge in all content areas. The primary strategy employed by Sexual Health Education for Adolescents is to address the cognitive learning domain. The curriculum aligns to national health education standards and is intended to be implemented by classroom teachers. The lessons can be delivered according to the schedule that works best for schools (e.g., twice a week, once a week, every days) within a school semester.
15845467|NCT04079595|Device|Head immobilization mask|Immobilization
15845468|NCT04079582|Other|Dialysate magnesium formulation of 1.5 mEq/L (0.75 mmol/L).|(Dialysate magnesium concentration currently used in Canada and the United States)
15845469|NCT04079582|Other|Dialysate magnesium formulation of ≤1.0 mEq/L (≤0.5 mmol/L).|(Dialysate magnesium concentration currently used in Canada and the United States)
15845470|NCT04079569|Behavioral|Tobacco|Quit Smoking For a Healthy Family - This is a family-based psycho-education intervention using lay health worker (LHW) outreach. LHW will be trained to recruit smoke-family dyads and provide education and information about tobacco and health, and smoking cessation resources through 2 small-group education sessions and 2 individual phone calls over a 2-month period.
15845471|NCT04079569|Behavioral|Healthy Living|"In this comparison arm, participants will receive the same number of contacts on the same schedule and in the same format (2 small group sessions and 2 telephone calls). The comparison LHWs will receive training about Healthy Living focusing on nutrition and physical activity education. Participants will also receive the Smoking Cessation Resource Handout."
15845472|NCT04079556|Behavioral|Tobacco LHW|Quit Smoking For a Healthy Family - This is a family-based psycho-education intervention using lay health worker (LHW) outreach. LHW will be trained to recruit smoke-family dyads and provide education and information about tobacco and health, and smoking cessation resources through 2 small-group education sessions and 2 individual phone calls over a 2-month period.
15845473|NCT04079543|Other|NPO past midnight|NPO after midnight (solids and liquids), except for a sip of water with medication.
15845474|NCT04079543|Other|NPO|No solids after midnight. Clear liquids up to 2 hours prior to procedure. Patients can take medications with a sip of water.
15845475|NCT04079530|Drug|K-877 IR 0.2 mg/day|K-877 IR 0.1 mg tablet
15845476|NCT04079530|Drug|K-877 CR 0.4 mg/day|K-877 CR 0.4 mg tablet
15845477|NCT04079530|Drug|K-877 CR 0.8 mg/day|Two K-877 CR 0.4 mg tablet
15845478|NCT04079517|Drug|Tamoxifen|A registered SERM drug, Tamoxifen.
15845479|NCT04079504|Procedure|Ligation of indirect hernia sac|Indirect inguinal hernia sac will be separated from the spermatic cord and contents of the sac will be reduced before ligating it at the deep inguinal ring.
15845480|NCT04079504|Procedure|Non-ligation of Indirect Inguinal hernia sac|the indirect inguinal hernia sac will be separated from the spermatic cord and reduced/inverted in to the peritoneal cavity through the deep inguinal ring along with its contents.
15845481|NCT04079491|Other|questionnaire survey|A web-based questionnaire will be send by the trade union for dental hygienists
15845482|NCT04079478|Other|AI|Artificial intellignece colonoscopy
15845483|NCT04079465|Device|O2matic|O2matic controls oxygen supply with a closed-loop feedback from a pulse oximeter. The aim is to maintain SpO2 within a predefined target interval according to guidelines for the specific condition causing hypoxemia, with the lowest possible supplementation of oxygen.
15845484|NCT04079452|Drug|Doravirine|Doravirine 100 mg tablet
15845485|NCT04079452|Drug|Descovy|Tenofovir alafenamide 25 mg / emtricitabine 200 mg tablet
15845486|NCT04079439|Behavioral|Physical activity with tailored e-health support|The planned e-health intervention will contain several elements: A motivating smartphone app registers indoor- and outdoor activity as well as activity from the use of an ergometer-bike. For recording of outdoor activity commercial wrist-born accelerometers will be used. The app-solution will be motivating and result in a reward after a predefined level of activity.
15845487|NCT04079426|Other|Sampling of Blood and bronchoalveolar lavage|Multiplex assays for pro- and anti-inflammatory markers and incubation of immune cells isolated from serum and bronchoalveolar lavage fluid of patients with ARDS.
15845488|NCT04079413|Drug|GP40071|GP40071, 100 per milliliters (U/mL) (dose range of 1 unit to 80 units) self-administered by SC injection, immediately (within 5-10 minutes) before meal intake.
15845489|NCT04079413|Drug|NovoRapid® Penfill®|NovoRapid® Penfill®, 100 per milliliters (U/mL) (dose range of 1 unit to 80 units) self-administered by SC injection, immediately (within 5-10 minutes) before meal intake.
15845490|NCT04079387|Device|ENDOTRACHEAL TUBE + STYLET|"The experimental group consists in intubating the trachea with an endotracheal tube + stylet with a straight-to-cuff shape and a bend angle of 25° to 35°"
15845491|NCT04079387|Device|ENDOTRACHEAL TUBE ALONE|intubating the trachea with an endotracheal tube alone
15845492|NCT04079374|Drug|Etanercept|Subcutaneous injections
15845493|NCT04079374|Drug|Enbrel|Subcutaneous injections
15845494|NCT04079361|Diagnostic Test|Blood samples|Bood samples during prenatal and postnatal visits
15845495|NCT04079348|Device|Oasis ECM|The patient will undergo harvesting of a split-thickness skin graft using a dermatome set at standard depth with the subsequent application of Oasis Extracellular Matrix to their donor site wound.
15845496|NCT04079348|Other|standard wound care|The patient will undergo harvesting of a split-thickness skin graft using a dermatome set at standard depth with the subsequent application of standard wound care to their donor site wound.
15845500|NCT04079283|Diagnostic Test|Clinical|Clinical: A diagnostic model incorporating clinical variables (Age, Pathological diagnosis, level of serum tumor biomarkers etc.)
15845501|NCT04079283|Diagnostic Test|Semantic|Semantic: A diagnostic model incorporating semantic radiological features (shape, location, border, density etc.)
15845502|NCT04079283|Diagnostic Test|Radiomic|Radiomic: A diagnostic model incorporating quantitative radiomic features (histogram, texture, morphology etc.)
15845503|NCT04079270|Other|Nutrition intervention|The diet recommendations will be provided by a certified dietitian. Participants will be asked to document their food intake and daily activities including exercise and sleep using a dedicated smartphone app throughout the intervention period.
15845504|NCT04079257|Other|Blood collection for measurement of eculizumab peak concentrations|collection of blood
15845505|NCT04079244|Behavioral|Video game|"Children receive a tablet with a video game at their arrival on the unit until the introduction of the anesthesia mask.
~The video game used is Le Héros C'est Toi, a game specially developed for the unit. The game recreates the hospital environment and includes mini-games geared to children."
15845506|NCT04079244|Behavioral|Animated cartoon|"Children receive a tablet with an animated cartoon at their arrival on the unit until the introduction of the anesthesia mask.
~The cartoon used is L'âge de glace, an animated cartoon geared to children."
15845507|NCT04079231|Drug|Brolucizumab|Intravitreal Injection
15845508|NCT04079231|Drug|Aflibercept|Intravitreal injection
15845509|NCT04079218|Drug|Estradiol Vaginal Insert|Using a pre-loaded single-use plastic applicator, participants will insert one 10 microgram estradiol tablet intravaginally daily for 2 weeks and then one tablet twice weekly for the remainder of the study for a total of 12 weeks.
15845510|NCT04079205|Device|Wearable Device(exoRehab)|rehabilitation program for patients after Anterior Cruciate Ligament Reconstruction using Wearable Device (exoRehab)
15845511|NCT04079205|Behavioral|Home rehabilitation program|rehabilitation program for patients after Anterior Cruciate Ligament Reconstruction
15845512|NCT04079192|Device|Biolimus A9 Drug Coated Balloon|A non-surgical procedure that uses a catheter to place a semi-compliant angioplasty drug coated balloon to open up coronary arteries that have been narrowed by atherosclerosis. The balloon is inflated to treat the stenosis and transfer the drug to arterial wall, and then is deflated and withdrawn.
15845513|NCT04079192|Device|SeQuent Please Paclitaxel Drug Coated Balloon|A non-surgical procedure that uses a catheter to place a semi-compliant angioplasty drug coated balloon to open up coronary arteries that have been narrowed by atherosclerosis. The balloon is inflated to treat the stenosis and transfer the drug to arterial wall, and then is deflated and withdrawn.
15845514|NCT04079179|Drug|Cobimetinib|All groups will receive the same intervention. Cobimetinib will be given orally at a maximum dose of 60mg daily for 21 days on, then 7 days off, in a 28-day treatment cycle for a total of 12 cycles (approximately 12 months).
15845515|NCT04079166|Biological|SCIB1 administered with a small, hand-held electroporation device (TriGrid™ delivery system version 2.0 [TDS-IM v2.0]).|"The plan for this research study is for SCIB1 to be given for up to 85 weeks, in combination with pembrolizumab according to the current label.
~After receiving the first dose of SCIB1, the patient will receive SCIB1 at 4, 7, 13 and 25 weeks, then every 12 weeks up to Week 85. Pembrolizumab treatment will be started 1 week after the first dose of SCIB1 and given every 6 weeks.
~Pembrolizumab will be given by an infusion into the patient's vein. This normally takes about 30 minutes to complete.
~On each occasion, SCIB1 will be given by two injections into a muscle in a different limb, e.g. one into the upper arm and the other into the thigh. Instead of a normal needle and syringe, a small, hand-held electroporation device (TDS-IM v2.0) will be used to inject SCIB1 into the muscles."
15845516|NCT04079166|Device|Electroporation device (TDS-IM v2.0).|The small, hand-held electroporation device (TDS-IM v2.0) that will be used to administer SCIB1 for up to 85 weeks.
15845517|NCT04079153|Device|Mandibular advancement Appliance|Advances the mandible at desired range at a fixed vertical dimension
15845518|NCT04079140|Drug|Dinoprostone|1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) self-inserted by the patient 12 hours before IUD insertion.
15845519|NCT04079140|Drug|placebo|one tablet of placebo self-inserted by the patient 12 hours before IUD insertion.
15845520|NCT04079127|Device|Patients who met the inclusion/exclusion criteria to receive the Avenir Müller stem.|Consecutive cohort of patients enrolled at every site who received the Avenir Müller stem.
15845521|NCT04079114|Device|Patients who received the Stafit Acetabular System|Patients, suffering from severe hip pain and disability, requiring primary total hip arthroplasty with high risk of dislocation, who meet the inclusion/exclusion criteria.
15845522|NCT04079101|Drug|BIIB104|Administered as specified in the treatment arm.
15845523|NCT04079101|Drug|Placebo|Administered as specified in the treatment arm.
15845524|NCT04079088|Drug|Placebo|Administered as specified in the treatment arm.
15845525|NCT04079088|Drug|BIIB061|Administered as specified in the treatment arm.
15845526|NCT04079088|Biological|Interferon-beta1|Stable dose as prescribed by the physician.
15845527|NCT04079088|Drug|Glatiramer acetate|Stable dose as prescribed by the physician.
15845528|NCT04079075|Other|Cognitive training|"This comprises training using using the cogweb software, both in person and remotely:
~i) in person training: 30-minute sessions, supervised by a trained nurse, twice weekly .
~ii) remote training: unsupervised 30-minute sessions, to be performed at home at the participants will."
15845529|NCT04079075|Behavioral|Physical activity|This is based on 60-minute sessions including aerobic, resistance, agility/balance and flexibility exercises, directed by a physical education teacher and supervised by a nurse, twice weekly.
15845530|NCT04079075|Behavioral|Nutrition education|"This is based on monthly 180-minute sessions, directed by a nutritionist, comprising:
~i) Presentation and discussion of healthy and easy to cook recipes by the nutritionist; ii) Preparation of healthy meals by the participants, followed by a period of social interaction between the participants while consuming the meals prepared."
15845531|NCT04079075|Behavioral|Adaption to memory loss|This is based on monthly 30-minute sessions, directed by a psychologist or a nurse, who will provide strategies that participants may use in their daily life to cope with memory loss.
15845558|NCT04078841|Dietary Supplement|ReaLife+ (RLP)|RLP is a dietary supplement containing Acetogenins, vitamin, mineral and amino acids.
15845559|NCT04078841|Other|Inert Brown powder|Brown powder Inert brown powder to look similar to RLP
15845532|NCT04079075|Diagnostic Test|Diagnosis of hearing impairment|Before implementing the sessions of cognitive training, physical activity, nutrition education and adaption to memory loss, an audiologist will perform an audiogram to all participants. Those with auditive performance inferior to the reference values will be referred for a medical appointment with an otolaryngologist.
15845533|NCT04079062|Biological|ONO-4685|Single ascending dose of ONO-4685 will be administered by intravenous continuous infusion at the designated speed.
15845534|NCT04079062|Biological|Placebo|Placebo will be administered by intravenous continuous infusion at the designated speed.
15845535|NCT04079062|Biological|KLH|KLH 1 mg per dose will be subcutaneously administered. In addition, all subjects will be administered placebo after KLH administration.
15845536|NCT04079062|Biological|KLH, ONO-4685|Part C will be conducted in a study design that ONO-4685 will be administered within the dose range, for which the safety has been confirmed in Part A, after administering KLH in the dose regimens selected according to the investigation result in Part B.
15845537|NCT04079062|Biological|KLH, placebo|Part C will be conducted in a study design that placebo will be administered within the dose range, for which the safety has been confirmed in Part A, after administering KLH in the dose resimens selected according to the investigation result in Part B.
15845538|NCT04079049|Procedure|Surgical intervention|Surgical intervention by liver resection, ablation or stereotactic body radiotherapy as complement to oncological treatment
15845539|NCT04079049|Drug|Control|Oncological treatment in control group
15845540|NCT04079023|Procedure|Sleeve Gastrectomy|Subtotal vertical gastrectomy
15845541|NCT04079010|Procedure|BFR|Blood flow restriction (BFR) training is a non-invasive technique that uses wraps, bands, or inflated blood pressure cuffs to change blood flow within targeted muscles. Occlusion pressure of the femoral artery will be determine before each training session using the Delfi Personalize Tourniquet System for Blood Flow Restriction (2.0) which has embedded ultrasound technology to continually measure the blood flow and with auto-adjust the pressure. The target percent of occlusion is 50% of total blood flow while completed a prescribed resistance training regimen 4 times per week.
15845542|NCT04079010|Dietary Supplement|Arginine|"The BFR+Arg group will consume Arginine supplement daily throughout the course of the study. Supplements were manufactured by Kyowa, a US-based cGMP-compliant contract manufacturing facility independently audited and pre-qualified by the quality compliance firm, Obvium*Q, LLC (Dallas, TX). Manufacturing batch records for production of each of the supplements were maintained by the manufacturer and finished supplements were independently assayed for identity, purity, potency, and composition using appropriate USP, AOAC, or BAM methods at the independent, analytical laboratory, Dyad Labs (Salt Lake City, UT), prior to approval for release and consumption of the supplements by participants.
~Each serving of the supplements were formulated to contain 3,000 mg L-Arginine (ARG; Kyowa). Each supplement also contained the inert and non-insulinotropic excipient ingredients, microcystalline cellulose and silicon dioxide."
15845543|NCT04079010|Dietary Supplement|Placebo Pill|"The CON and BFR groups will consume placebo pill daily throughout the course of the study. Supplements were manufactured by Kyowa, a US-based cGMP-compliant contract manufacturing facility independently audited and pre-qualified by the quality compliance firm, Obvium*Q, LLC (Dallas, TX). Manufacturing batch records for production of each of the supplements were maintained by the manufacturer and finished supplements were independently assayed for identity, purity, potency, and composition using appropriate USP, AOAC, or BAM methods at the independent, analytical laboratory, Dyad Labs (Salt Lake City, UT), prior to approval for release and consumption of the supplements by participants.
~Each serving of the supplements were formulated to contain 3,000 mg Maltodextrin placebo (PLA; MALTRIN-M100; Grain Processing Corporation; Muscantine, IA). Each supplement also contained the inert and non-insulinotropic excipient ingredients, microcystalline cellulose and silicon dioxide."
15845544|NCT04078997|Other|nasopharyngeal swab|A nasopharyngeal swab will be collected from consenting individuals by inserting a commercially-available dacron swab to the nasopharynx, gently rotating before removing.
15845545|NCT04078984|Other|Experimental|"Daily measures of End Inspiratory Pressure with respiratory synchronisation optimised by use of EAdi
~Daily spontaneous breathing trial using low levels of pressure support
~Pplat, Respiratory System Compliance, Driving Pressure, PEEP, Tidal Volume will be monitored daily as well as clinical and other routine ventilatory data. Data concerning initial severity of ARDS, and duration of ARDS, controlled mechanical ventilation, sedation and neuromuscular blockade and date of first spontaneous breathing trial will be collected. A weaning test will be conducted daily."
15845546|NCT04078971|Other|Western diet|Subjects in this intervention will follow a normal western diet
15845547|NCT04078971|Other|ketogenic diet|Subjects in this group will follow a low carbohydrate ketogenic diet
15845548|NCT04078958|Dietary Supplement|Salmon fishmeal|Salmon fishmeal with high protein content
15845549|NCT04078958|Dietary Supplement|Whey|Whey with high protein content
15845550|NCT04078932|Behavioral|Violence Prevention Conversation Script to Discuss Safely Navigating Police Encounters|A conversation script to facilitate conversations on safely navigating police encounters as anticipatory guidance and violence prevention strategy. The conversation script will be created using expert recommendations from existing resources and using recommendations (determined from focus groups) from black male youth and their caregivers. The script will be patient-centered.
15845551|NCT04078919|Dietary Supplement|Nut consumption|daily consumption of 20 percent of daily calories intake from nuts (pistachio, almond and peanuts)
15845552|NCT04078919|Other|Low calorie diet|Low calorie diet
15845553|NCT04078906|Other|n3-LCPUFA enriched Intravenous Lipid Emulsion|To start from D0 at 1g/kg/day and increase by 1 g/kg daily till reaching 3 g/kg/day.
15845554|NCT04078893|Other|telephone recruitment|using telephone to recruit inactive donors on two different methods
15845555|NCT04078880|Dietary Supplement|Sucrosomial iron plus ascorbic acid|A number of 41 subjects are supplemented with 30 mg of iron plus 70 mg of ascorbic acid daily for 30+/-5 days before orthopedic surgery.
15845556|NCT04078867|Procedure|tricuspid valve repair|Tricuspid valve repair during mitral valve replacement for rheumatic heart disease using suture (DeVega) repair or ring annuloplasty
15845557|NCT04078854|Behavioral|Diabetes education|Both presentations are identical in educating patients how to control diabetes and the risk of future amputations in diabetes, but the experimental arm presentation will also include information regarding sexual dysfunction in diabetes.
15845560|NCT04078828|Procedure|Pelvic floor Reconstruction|Pelvic floor Reconstruction after laparoscopic anterior resection and double-stapling technique anastomosis were finished.
15845561|NCT04078802|Procedure|VNOTES/VH|same as above
15845562|NCT04078776|Other|No intervention|There is no intervention in this study
15845563|NCT04078763|Behavioral|Rehabilitation protocol with visual-auditory feedback|The rehabilitation protocol with visual-auditory feedback is based on 8 sessions, over a period of 1 month, with 2 sessions per week. Each session lasts 45 minutes. During a session, the participant has to localize a sound around him, at hand. For this, he has to direct his head (which acts as a pointer) to the place where he seems to get the sound. Then, he validates his answer using the joystick placed in his hand. Regardless of the answer given (exact or incorrect), the subject will always have a visual-auditory feedback
15845564|NCT04078763|Behavioral|Rehabilitation protocol with visual feedback|The rehabilitation protocol with visual feedback is based on 8 sessions, over a period of 1 month, with 2 sessions per week. Each session lasts 45 minutes. During a session, the participant has to localize a sound around him, at hand. For this, he has to direct his head (which acts as a pointer) to the place where he seems to get the sound. Then, he validates his answer using the joystick placed in his hand. Regardless of the answer given (exact or incorrect), the subject will only have a visual feedback.
15845565|NCT04078763|Behavioral|SPHERE protocol|"Data from spatial sound perception will be recorded in three dimensional space (azimuth, elevation, and depth). First, the pointing error will be computed separately for azimuth, elevation, and depth, in terms of constant error (absolute and signed) and variable error. Then, these separate errors will be combined into a cumulative error 3d-D, hence summarizing all three space dimensions, and taking into account absolute and variable error in one measure. This lasts 10 minutes and the result is expressed by the 3d-D value"
15845566|NCT04078763|Behavioral|French Matrix Test|This test assesses the intelligibility threshold defined as the noise level (in decibels) for which the subject can repeat 50% of the words heard (in dichotic listening), resulting in an Speech Recognition Threshold (SRT) value. This test lasts 10 minutes.
15845567|NCT04078763|Behavioral|Speech Spatial and Qualities of Hearing Scale (SSQ15) questionnaire|15 items questionnaire (each answer to questions is quoted between 0 and 10) resulting in a global SSQ 15 score. It takes 10 minutes to fill the questionnaire.
15845568|NCT04078750|Behavioral|Tailored medication adherence plan|Comparison of mean daily medication adherence between intervention and control groups over 3 months, as measured by MEMS caps.
15845569|NCT04078737|Drug|Ticagrelor and Aspirin|"Day of randomization:
~Day1:Ticagrelor 180mg; placebo of clopidogrel 300mg; aspirin 75-300mg (open label) Day2-21st: Ticagrelor 90mg bid/day; placebo of clopidogrel 75mg; aspirin 75mg (open label) Day 22nd-3 months:Ticagrelor 90mg bid/day; placebo of clopidogrel 75mg"
15845570|NCT04078737|Drug|Clopidogrel and Aspirin|"Day of randomization:
~Day 1: Clopidogrel 300mg; placebo of ticagrelor 180mg; aspirin 75-300mg (open label) Day2-21st: Clopidogrel 75mg/day; placebo of ticagrelor 90mg bid/day; aspirin 75mg (open label) Day 22nd-3 months:Clopidogrel 75mg; placebo of ticagrelor 90mg bid/day"
15845571|NCT04078724|Dietary Supplement|5-HTP|5-HTP that have Good Manufacturing Practice certification will be used and participants will be suggested to be take the 5-HTP supplementation at bedtime.
15845572|NCT04078724|Other|Without 5-HTP|Subject will not take 5-HTP
15845573|NCT04078711|Drug|Losartan 100Mg Tab|100Mg Tab, qd, po, 6 months
15845574|NCT04078711|Drug|Qianyangyuyin 20g Granule|20g, Granule, bid, po, 6 months
15845575|NCT04078711|Drug|placebo|Similar granule manufactured to mimic qianyangyuyin granule, 20g, Granule, bid, po, 6 months
15845576|NCT04078698|Device|Immunoadsorbers GLOBAFFIN®, LIGASORB® and IgEnio®|Documentation of the treatment with one of the immunoadsorbers GLOBAFFIN®, LIGASORB® or IgEnio® depending on the patient's underlying disease
15845577|NCT04078685|Procedure|Standard catheter ablation|Radiofrequency catheter ablation using a standard ablation catheters: not equipped with contact-force sensing
15845578|NCT04078685|Procedure|Contact Force-sensing-based catheter ablation|Radiofrequency catheter ablation using a Contact-Force-sensing ablation catheter
15845579|NCT04078672|Procedure|NOTAL-OCT V3.0|AMD and DR patients
15845580|NCT04078659|Drug|Propofol infusion|Following induction of anaesthesia, propofol infusion will be started 75 mcg/kg/min for the first 10-15 minutes, then a maintenance infusion of propofol (50 mcg/kg /min)
15845581|NCT04078659|Drug|Magnesium Sulfate infusion|Before induction of anaesthesia, Magnesium Sulfate infusion will be started at 40 mg/kg in 100 ml saline over 10 minutes as the loading dose then Magnesium sulfate infusion 10-15 mg/kg/hr started immediately after induction of anaesthesia
15845582|NCT04078659|Drug|Lidocaine|Patients will receive iv lidocaine 1.5 mg/kg before induction of anaesthesia
15845583|NCT04078659|Drug|Fentanyl|Patients will receive fentanyl 1-2 mcg/kg before induction of anaesthesia
15845584|NCT04078659|Drug|Propofol|Patients will receive propofol in a dose of 1-2 mg /kg
15845585|NCT04078659|Drug|Atracurium|Patients will receive 0.6 mg /kg iv atracurium over 60 sec, to facilitate tracheal intubation
15845586|NCT04078659|Procedure|Mechanical Ventilation|Patients lungs will be ventilated using the volume controlled mechanically ventilated with 40% oxygen in the air with positive end-expiratory pressure (PEEP) of 5 cmH2O, tidal volume 500 ml and Respiratory Rate of 12 per minute
15845587|NCT04078646|Other|Intervention with soy protein isolate|"Test meals will be served to the subjects, containing soy protein isolate:
~350 mL carrot/tomato juice (50:50, v/v), with 30 g added soy protein, plus 5 ml peanut oil
~as morning test meal, served together with 40 g toasted bread and 20 g of cream-cheese plus 10 g margarine."
15845588|NCT04078646|Other|Intervention with whey protein|"Test meals will be served to the subjects, containing soy protein isolate:
~350 mL carrot/tomato juice (50:50, v/v), with 30 g added whey protein isolate, plus 5 ml peanut oil
~as morning test meal, served together with 40 g toasted bread and 20 g of cream-cheese plus 10 g margarine."
15845589|NCT04078646|Other|Intervention without protein addition|"Test meals will be served to the subjects, containing soy protein isolate:
~350 mL carrot/tomato juice (50:50, v/v), plus 5 ml peanut oil
~as morning test meal, served together with 40 g toasted bread and 20 g of cream-cheese plus 10 g margarine."
15845590|NCT04078633|Behavioral|Hand hygiene interventions|Interventions are commonly used physical props for handwashing and commonly used hygiene promotion activities.
15845673|NCT04078022|Other|Placebo|0.5 mL of normal saline is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29.
15845591|NCT04078620|Diagnostic Test|Survey for drug drug interactions on medscape and lexicomp applications|Survey for drug drug interactions on Medscape and Lexicomp interaction checker applications
15845592|NCT04078607|Behavioral|Rapid Visual Information Processing task|A series of numbers appeared on a computer screen at a rate of one per minute. Each participant was required to identify any series of three consecutive odd or even numbers by hitting the space bar on the keyboard. The task lasted 15 minutes and included a 1-minute practice session before food being served. Participants were instructed to eat at will while completing the computer task.
15845593|NCT04078607|Behavioral|None or Control condition|Participant were instructed to eat at will during a 15-minute duration.
15845594|NCT04078594|Other|sepsis e-alert|At 2-each month interval, the e-alert will be activated in five new randomly selected wards, until all wards eventually will have active alert
15845595|NCT04078581|Other|Questionnaire and fecal sample collection|Questionnaire and fecal sample collection in order to select donors for FMT.
15845596|NCT04078568|Drug|IVIG|IVIG at a single dose of 2 g/kg, with the maximum dose of 60g
15845597|NCT04078568|Drug|Aspirin|Aspirin 30 mg/kg in oral per day (given in 3 divided doses), then 3 to 5 mg/kg per day when fever subsides for 3 days and C-reactive protein (CRP) is normal. Aspirin will be continued for at least 6 weeks after onset of illness.
15845598|NCT04078568|Drug|Prednisolone|Intravenous methylprednisolone 1.6 mg/kg per day (given in 2 divided doses, with the maximum dose 60mg of prednisolone ) for 3 days, then changed to oral prednisolone 2 mg/kg when fever subsides for 3 days. If CRP is normal, the oral dose will be reduced every 5 days from 2 mg/kg to 1 mg/kg to 0.5 mg/kg (tapered over 15 days). Then prednisolone will be discontinued.
15845599|NCT04078555|Drug|ENERGI-F703 GEL|"The study medication will be applied twice daily until the end of 84 days or up to the visit confirmation of complete ulcer closure, whichever comes first.
~The estimated amount of study medication applied to the ulcer area is 0.25 cm (about 0.11 g) in length per cm2 of ulcer size."
15845600|NCT04078555|Drug|ENERGI-F703 GEL matched vehicle|"The study medication will be applied twice daily until the end of 84 days or up to the visit confirmation of complete ulcer closure, whichever comes first.
~The estimated amount of study medication applied to the ulcer area is 0.25 cm (about 0.11 g) in length per cm2 of ulcer size."
15845601|NCT04078529|Other|5 day falls prevention training|Intensive training on balance, gait re-education, functional activities, backwards chaining and postural control, completed at 0 and 12 weeks.
15845602|NCT04078529|Other|Home exercise programme|A modified version of the Falls Management Exercise programme (FaME) provided in written or audio format and completed over 12 weeks.
15845603|NCT04078529|Other|Environmental Assessment|Use of the Homefast assessment tool to reduce risk of falls at home.
15845604|NCT04078516|Diagnostic Test|Perception Threshold Tracking (PTT)|low-current electrical stimulation of both large- and small nerve fibers.
15845605|NCT04078516|Diagnostic Test|Axon-flair mediated respons|Laser-doppler examination of small blood vessels in the peripheral skin.
15845606|NCT04078516|Diagnostic Test|Heart rate variability|4 measurements of heart rate.
15845607|NCT04078516|Diagnostic Test|Quantitative Sensory Testing (QST)|Seven tests measuring 13 parameters including heat- and cold-detection and pain thresholds, mechanical pain treshold, mechanical detection threshold, pressure pain treshold and vibration threshold.
15845608|NCT04078516|Diagnostic Test|Peripheral blood pressure and transcutaneous oxygen tension|Ankle/brachial index, toe/brachial index, TcpO2.
15845609|NCT04078516|Diagnostic Test|Magnetic Resonance Imaging (MRI)|MRI-scans of peripheral nerves and the central nervous system. Blood oxygen level dependent (BOLD) MRI.
15845610|NCT04078516|Diagnostic Test|Questionnaires|Questionnaires for detecting painful neuropathy
15845611|NCT04078516|Diagnostic Test|Corneal Confocal Microscopy /CCM)|Confocal microscopy of the cornea measuring NBD, NFD, NFL
15845612|NCT04078477|Other|Body positioning|Comparison lateral tilt bed to standard patient´s body positioning in the bed.
15845613|NCT04078464|Other|Mindfulness Training Alone|Participants will lie down and listen to a pre-recorded guided mindfulness meditation for 36 minutes.
15845614|NCT04078464|Other|Acute Physical Activity Alone|Physical activity will include a 6 minute stretching session, 1 minute transition to treadmill, 3 minute warm up at a participant chosen pace on the treadmill, 20 minutes of walking at a moderate pace at target heart rate, 3 minute cool down at 2.0-2.5 mph, 1 minute transition off treadmill and 2 minutes of stretching.
15845615|NCT04078464|Other|Acute Physical Activity and Mindfulness Training Together|Participants will listen to a pre-recorded mindfulness meditation which will guide them through a 6 minute stretching session, 1 minute transition to treadmill, 3 minute warm up at a participant chosen pace on the treadmill, 20 minutes of walking at a moderate pace at target heart rate, 3 minute cool down at 2.0-2.5 mph, 1 minute transition off treadmill and 2 minutes of stretching.
15845616|NCT04078451|Procedure|preserve the main cystic artery|The experimental group preserve the main cystic artery, and the control group cut off the main cystic artery
15845617|NCT04078438|Device|neurofeedback augmentation|"Neurofeedback training was performed using a Neurocybernetics EEG Biofeedback system (Neurocybernetics Inc., Encino, CA, USA). The neurofeedback protocol was determined by the neurofeedback team, which included 3 psychiatrists, in consideration of the patient's main symptoms.
~The neurofeedback augmentation group was asked to participate in 12 weeks of combined therapy of medication and 12-24 sessions of neurofeedback training. Patients in the neurofeedback augmentation group received sensorimotor rhythm (SMR) beta or beta training for 30 minutes, and then alpha/theta (A/T) training for 30 minutes in each session.
~To reduce the impact of confounding factors, the medication-only (treatment as usual, TAU) group visited at the same schedule as neurofeedback augmentation group and received psychotherapy placebo sessions. The medication-only (treatment as usual, TAU) group maintained the same medication use as that before the study."
15845618|NCT04078438|Drug|treatment as usual|The neurofeedback augmentation group and the medication-only group maintained the same medication use as that before the study.
15845619|NCT04078438|Other|psychotherapy placebo sessions|To reduce the impact of confounding factors, the medication-only (treatment as usual, TAU) group visited at the same schedule as neurofeedback augmentation group and received psychotherapy placebo sessions instead of neurofeedback training sessions. These sessions included psychological assessment and supportive psychotherapy.
15845672|NCT04078022|Biological|SF2a-TT15 Shigella Vaccine|0.5 mL of the vaccine is administered via an intramuscular injection into the deltoid muscle on Study Day 1 and Study Day 29.
15845620|NCT04078425|Drug|Aldosterone Antagonists|aldosterone antagonist will be applied to patients of heart failure with preserved ejection fraction, level of the drug will be sampled before administration of the drug and follow up will be sampled after one month
15845621|NCT04078399|Drug|Azacitidine combined with interferon preemptive treatment|Azacitidine combined with interferon preemptive therapy for prevention and treatment of recurrence of allogeneic transplantation of myeloid tumors (AML/MDS/MPN) in the blood system
15845622|NCT04078386|Biological|Placebo|Patients received the test group Placebo weekly administered subcutaneously for 24 times.
15845623|NCT04078386|Biological|RC18 240 mg|Arm Description:Patients received the test group RC18 240mg weekly administered subcutaneously for 24 times.
15845624|NCT04078386|Biological|RC18 160 mg|Patients received the test group RC18 160mg weekly administered subcutaneously for 24 times.
15845625|NCT04078373|Behavioral|Immediate urination|Patients with decreased cognitive ability will be taught to immediately go to the toilet upon feeling the urge to urinate and to be independent in urinating.
15845626|NCT04078373|Behavioral|Bladder diary|Patients with normal cognitive abilities will be instructed to go to the toilet every 2-3 hours regardless of the urge to urinate
15845627|NCT04078360|Behavioral|AMBIT (Alcohol use disorders- mobile based Brief Intervention treatment) intervention|"The intervention will consist of participants receiving messages and/IVR calls not more than twice or thrice a week on their mobile phone for a duration of 8 weeks. Messages/IVR calls will be sent through VIAMO's technology platform. Each week messages will be focussed on specific content areas derived from the formative research of the study. Some of the components of the intervention include:
~Self awareness messages
~Self reflection messages
~Motivational messages
~Messages on safe drinking, alcohol reduction, drinking management, risk management, craving management and drinking alternatives.
~Health education messages
~Personalized feedback and information
~Help-seeking resources
~Goal setting messages"
15845628|NCT04078360|Behavioral|Face to face Brief Intervention|The intervention will consist of the participants receiving the BI based on the WHO Mental Health Gap Action Programme (mhGAP) intervention from a trained researcher. The BI will be conducted over a single session (5-10 mins).
15845629|NCT04078360|Behavioral|BI leaflet intervention|The intervention will consist of an educational BI leaflet consisting of health information on alcohol consumption, and tips to manage and reduce drinking.
15845630|NCT04078347|Procedure|Paravertebral block at T4 and T5 level|Paravertebral block is performed at T4 and T5 level under realtime ultrasound guidenance with 10ml of 0.5% ropivacaine for each block, respectively.
15845631|NCT04078334|Other|MATCH|In the first days of hospitalization, the physiotherapist determines the score linked to the patient's mobility profile using of a decisional tree. The PA program has 2 or 3 exercises to be done with or without supervision 3 times per week day during hospitalization. These daily exercises are prescribed by the doctor and taught by the physiotherapist.
15845632|NCT04078334|Other|PATH|In the days prior to discharge, the physiotherapist determines the patient's mobility profile using the decisional tree. When returning home after hospitalization, each PA program includes a daily walk as well as 3 or 4 exercises that can be completed in a 12 to 20 minutes timeframe. These daily exercises are prescribed by the doctor and taught by the physiotherapist in 2 sessions.
15845633|NCT04078334|Other|PATH 2.0|"In the first days of hospitalization, the physiotherapist determines the score linked to the patient's mobility profile using of a decisional tree. The PA program has 2 or 3 exercises to be done with or without supervision 3 times per week day during hospitalization. These daily exercises are prescribed by the doctor and taught by the physiotherapist.
~In the days prior to discharge, the physiotherapist determines the patient's mobility profile using the decisional tree. When returning home after hospitalization, each PA program includes a daily walk as well as 3 or 4 exercises that can completed in a 12 to 20 minutes timeframe. These daily exercises are prescribed by the doctor and taught by the physiotherapist in 2 sessions."
15845634|NCT04078321|Other|Mollii ®|The garment claims to have a 48 hours lasting effect of an hour of treatment. The garment should be worn for at least 1 hour every other day. All participants receive individually tailored garments and individually tailored appropriate training towards specific goals set in connection to study start. The garment is used in the home environment and the family is responsible for documentation of use in a diary. Measurements is performed following an ABAB design for four weeks. Measurement performed at 12 occasions during the four weeks are; spasticity, physical function, pain, sleep and adherence. Standardized protocols for the intervention are provided to involved physical therapists.
15845635|NCT04078308|Biological|Intravenous Injection of autologous mesenchymal stem cells|Intravenous injection 1 millions of bone-marrow derived autologous Mesenchymal Stem Cells (MSCs) per kg of patient's body weight in each dose, weeks 0 & 3
15845636|NCT04078308|Other|Intravenous injection of placebo|Intravenous injection of normal saline (sodium chloride 0.9%)
15845637|NCT04078295|Drug|E7389-LF|E7389-LF Intravenous infusion.
15845638|NCT04078295|Drug|Nivolumab|Nivolumab Intravenous infusion.
15845639|NCT04078282|Behavioral|Intervention group|see above
15845640|NCT04078269|Biological|Dendritic cell immunotherapy|Intravenous infusions of MIDRIXNEO-LUNG DCs every 2 weeks, using an intra-patient dose escalation scheme progressing along the following range: 10 x10E6 DCs (minimal dose), 20 x 10E6 DCs, 40 x 10E6 DCs, 80 x 10E6 DCs, 100 x 10E6 DCs (maximal dose), until exhaustion of the batch or occurrence of grade ≥3 toxicity event
15845641|NCT04078269|Biological|Antigen-specific DTH|Intradermal injection of 1 x 10E6 MIDRIXNEO-LUNG DCs at baseline and after completion of all i.v. DC vaccination rounds. This is used for assessment of induction of antigen-specific immune responses as part of in vivo immunomonitoring (delayed-type hypersensitivity cutaneous reaction as test read-out)
15845642|NCT04078269|Biological|Control DTH|Intradermal injection of 1 x 10E6 MIDRIX-CTRL DCs at baseline and after completion of all i.v. DC vaccination rounds. This is used for assessment of background (i.e. non-antigen-specific) reactivity (delayed-type hypersensitivity cutaneous reaction as test read-out)
15845643|NCT04078256|Other|Proprioceptive exercise program|Group A will carry out two sessions of proprioceptive training per week, in a total of 8 weeks, during the pre-season period (September-October). Each session will last approximately 30 minutes and will include 6 exercises. The execution of the exercises will be supervised by a physiotherapist and a national trainer of athletics.
15845644|NCT04078256|Other|Usual training routine|The subjects of the control group (group B) will be informed so that they do not include any change in their usual training routine.
15845645|NCT04078243|Device|CardioMEMS HF System|The CardioMEMS HF System is the first and only FDA-approved wireless heart failure monitor. The system is a safe, reliable way to help your patients manage their heart failure.
15845646|NCT04078230|Procedure|Extend LymphAdenectomy|Expanded lymph node dissection for right liver tumors included stations 12, 8, and 13, and stations 12, 1, 3, 7, and 8 for left liver tumors
15845647|NCT04078217|Device|Jintronix|Participants will perform an exercise program at home through a telerehabilitation platform called Jintronix.
15845648|NCT04078217|Other|Booklet|Home-based exercise program using a paper booklet (not the technology).
15845649|NCT04078204|Drug|Butylphthalide Soft Capsules|The experimental group will receive the Butylphthalide Soft Capsules during the 24-month intervention period. After the 24-month intervention,The experimental group will receive Butylphthalide Soft Capsules for the 6-month open treatment period.
15845650|NCT04078204|Drug|placebo Soft Capsules|The placebo group will receive the Placebo Soft Capsules during the 24-month intervention period. After the 24-month intervention,The placebo group will receive Butylphthalide Soft Capsules for the 6-month open treatment period.
15845651|NCT04078191|Drug|Tc 99m tilmanocept|Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
15845652|NCT04078178|Dietary Supplement|Niagen|Vitamin B3
15845653|NCT04078165|Device|Zero-Gravity|Free-floating, suspended personal radiation protection
15845654|NCT04078165|Device|Conventional radiation protection|Standard lead shields and aprons
15845655|NCT04078152|Drug|Durvalumab|IV infusion q4w with 1500mg durvalumab until progressive disease
15845656|NCT04078139|Drug|The MP/RP group|Miscible liquid of methylprednisolone and ropivacaine in this study will be peri-incisional scalp infiltration with 40mg methylprednisolone, 10 ml 1% ropivacaine and 10 ml normal saline miscible liquids for participants who will undergo elective craniotomy. The local infiltration solution containing will be infiltrated along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigator.
15845657|NCT04078139|Drug|The RP group|Miscible liquid of ropivacaine in this study will be peri-incisional scalp infiltration with 10 ml 1% ropivacaine and 10 ml normal saline miscible liquids for participants who will undergo elective craniotomy. The local infiltration solution containing will be infiltrated along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigator.
15845658|NCT04078126|Combination Product|BFF|Treatment with budesonide and formoterol furmate MDI (metered-dose inhaler)
15845659|NCT04078126|Combination Product|Symbicort Turbuhaler|Treatment with budesonide and formoterol furmate DPI (dry-powder inhaler)
15845660|NCT04078113|Other|Pupillometer|Measurements of pupillary dilatation with pupillometer to administer or not analgesia
15845661|NCT04078100|Procedure|Transseptal approach.|surgical approach to the mitral valve through the Fossa Ovalis by way of the right atrium.
15845662|NCT04078087|Drug|Non obese|After standard anesthesia monitoring, Administration of oxygen was performed for 3 minutes with 10 L/min fresh gas flow of 100% oxygen. After oxygen administration, 25% of (2 mg/kg) total propofol dose was injected over 3-5 seconds (Propofol Lipuro 1%, B. Braun Melsungen AG, Germany). The patients were observed and asked immediately whether they had pain in the arm, its VAS score, type of pain (burning, parathesia or other) and its onset was documented (to differentiate early or late type of pain).
15845663|NCT04078087|Drug|Obese.|After standard anesthesia monitoring, Administration of oxygen was performed for 3 minutes with 10 L/min fresh gas flow of 100% oxygen. After oxygen administration, 25% of (2 mg/kg) total propofol dose was injected over 3-5 seconds (Propofol Lipuro 1%, B. Braun Melsungen AG, Germany). The patients were observed and asked immediately whether they had pain in the arm, its VAS score, type of pain (burning, parathesia or other) and its onset was documented (to differentiate early or late type of pain).
15845664|NCT04078074|Device|Maxillary OSS|Maxillary OSS will be a night guard for the top teeth. Digital impressions will be taken at the first appointment. After delivery appointment the patient will take home a sleep test monitor and bruxism monitor to record respiration and muscle activity during sleep.This will be a 2 night sleep study (Night A will be without splint and Night B will be with splint). Therefore, the patient will sleep with the mouth guard one night and the monitoring device two nights. Subjects will also undergo cone beam computed tomography (CBCT) airway imaging with and without splint.
15845665|NCT04078074|Device|Mandibular OSS|Mandibular OSS will be a night guard for the bottom teeth.Digital impressions will be taken at the first appointment. After delivery appointment the patient will take home a sleep test monitor and bruxism monitor to record respiration and muscle activity during sleep.This will be a 2 night sleep study (Night A will be without splint and Night B will be with splint). Therefore, the patient will sleep with the mouth guard one night and the monitoring device two nights. Subjects will also undergo CBCT airway imaging with and without splint.
15845666|NCT04078074|Device|Modified farrar splint|Modified farrar splint will be a night guard for the top teeth that positions and maintains the lower jaw in a more forward position.Digital impressions will be taken at the first appointment. After delivery appointment the patient will take home a sleep test monitor and bruxism monitor to record respiration and muscle activity during sleep. This will be a 2 night sleep study (Night A will be without splint and Night B will be with splint). Therefore, the patient will sleep with the mouth guard one night and the monitoring device two nights. Subjects will also undergo CBCT airway imaging with and without splint.
15845667|NCT04078061|Behavioral|MABA|Adaptive, modular, behavioral intervention.
15845668|NCT04078061|Behavioral|EIBI|Early Intensive Behavioral Intervention
15845669|NCT04078048|Dietary Supplement|Antioxidants (Vitamin C, E )|For eight weeks, Vitamin C group was intervened with tablet vitamin c 500 mg once a day ,vitamin E group was intervened with Tablet vitamin E 600 I U twice a day.
15845670|NCT04078035|Behavioral|Socio-evaluative speech task, then Control|First session: 5-minute speech task designed to induce physiological arousal in a laboratory setting. Second Sessions: 5-minute rest period.
15845671|NCT04078035|Behavioral|Control, then Socio-evaluative speech task|First session: 5-minute rest period. Second session: 5-minute speech task designed to induce physiological arousal in a laboratory setting
15846181|NCT04073745|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15845674|NCT04078022|Biological|S. flexneri 2a strain 2457T Challenge Agent|Each participant will drink 120 mL of sodium bicarbonate buffer solution. Approximately 1 to 2 minutes later, the participant will ingest approximately 1500 cfu of S. flexneri 2a strain 2457T suspended in 30 mL of the bicarbonate buffer solution.
15845675|NCT04078009|Diagnostic Test|Aquagen|To compare the clinical allergic response after direct installation of an aqueous solution of Aquagen Timothy Grass pollen extract via nasal allergen challenge with the clinical allergic response after direct installation of an aqueous solution of Grazax Timothy Grass lyophilisate tablets via nasal allergen challenge in grass pollen allergic individuals.
15845676|NCT04078009|Diagnostic Test|Grazax|To compare the clinical allergic response after direct installation of an aqueous solution of Aquagen Timothy Grass pollen extract via nasal allergen challenge with the clinical allergic response after direct installation of an aqueous solution of Grazax Timothy Grass lyophilisate tablets via nasal allergen challenge in grass pollen allergic individuals.
15845677|NCT04077996|Device|Peritonitis treatment placed in APD|Antibiotic treatment of peritontiis placed in bags of Automated peritoneal dialysis.
15845678|NCT04077996|Device|Peritonitis treatment with one exchange in CAPD|Antibiotic treatment of peritontiis placed in one bag of Continuos ambulatory peritoneal dialysis per 6 hours each day.
15845679|NCT04077983|Drug|combined therapy using nab-paclitaxel and gemcitabine chemotherapy|"Day1 nab-paclitaxel 125mg/m2, Day8 nab-paclitaxel 125mg/m2
~Day1 gemcitabine 1000mg/m2, Day8 gemcitabine 1000mg/m2
~Three weeks is a course of treatment with a total of 4 courses."
15845680|NCT04077970|Biological|Intrauterine flushing of follicular fluid with granulosa cells|All patients in case and control groups will receive GnRH agonist protocol. Ovarian stimulation will be carried out when pituitary desensitization is achieved and is continued until the day of hCG administration. COCs aspiration will be performed 34-36h after hCG injection. Clear Follicular Fluids (without blood cells) which contain COCs will be used. After explaining the procedure and taking informed consent from the patients: Endometrial flushing after oocyte retrieval with 2 ml of clear FF plus granulose cells will be performed by an IUI catheter. The control group included 70 women who would not have FF endometrial flushing. In both groups, embryo transfer will be carried out 2-3 days later. Luteal phase support will be started the day after ovum pick up by the vaginal administration of progesterone daily for 16 days and will continued for up to12 weeks if pregnancy occurred. Pregnancy was diagnosed by measurement of β-hCG level and later was confirmed by Transvaginal sonography.
15845681|NCT04077957|Drug|Methotrexate|Methotrexate 10mg per week will be the background therapy in participants in Group 1. Experimental.
15845682|NCT04077957|Drug|Sulfasalazine|Sulfasalazine 2.25g per day will be the background therapy in participants in Group 1. Experimental.
15845683|NCT04077957|Drug|Hydroxychloroquine|Hydroxychloroquine 0.2g per day will be the background therapy in participants in Group 1. Experimental.
15845684|NCT04077957|Drug|Etanercept (50mg per week, for 4 weeks)|Participants in Group 1. Experimental who satisfied the criteria for high disease activity (ASDAS≥2.1) at every follow-up point will receive etanercept (50mg per week, for 4 weeks) in the next 4 weeks.
15845685|NCT04077957|Drug|Etanercept (50mg per week, for 2 weeks)|Participants in Group 1. Experimental who satisfied the criteria for low disease activity (2.1>ASDAS≥1.3) at every follow-up point will receive etanercept (50mg per week, for 4 weeks) in the next 2 weeks.
15845686|NCT04077957|Drug|Etanercept (50mg per week)|Participants in Group 2. Positive Control will receive etanercept (50mg per week, for 12 weeks) for 48 weeks.
15845687|NCT04077944|Diagnostic Test|maternal serum concentration of trace elements and heavy metals levels|The maternal serum levels of trace elements and heavy metals in both groups were measured using an inductively coupled plasma-mass spectrometry (ICP-MS)
15845688|NCT04077931|Other|exercises|Walking on treadmill with fixed 0% grade inclination
15845689|NCT04077918|Dietary Supplement|protein diet|100 CHD patients will be recruited and randomized into 2 groups with an additional animal or plant protein 18g per day
15845690|NCT04077905|Drug|Pegylated liposomal doxorubicin|35mg/m² ivgtt on day 1
15845691|NCT04077905|Drug|Etoposide|100mg/m² ivgtt on day 1
15845692|NCT04077905|Drug|Methylprednisolone|2 mg/kg ivgtt or PO days 1 to 3, 0.75 mg/kg ivgtt or PO days 4 to 7, 0.25 mg/kg ivgtt or PO days 8 to 10, 0. 1 mg/kg ivgtt or PO days 11 to 14,
15845693|NCT04077892|Drug|budesonide|SAR patients received treatment of a combination of budesonide and montelukast tablet or only intranasal budesonide randomly for 14 days
15845694|NCT04077879|Drug|ASP1617|Oral
15845695|NCT04077879|Drug|Placebo|Oral
15845696|NCT04077866|Drug|Temozolomide|Temozolomide is an FDA-approved drug that is given to patients
15845697|NCT04077866|Biological|B7-H3 CAR-T|B7-H3-targeting CAR-T cells derived from patient own peripheral blood mononuclear cells will be given to patients via intracerebral injection though an Ommaya catheter
15845698|NCT04077853|Drug|17 Hydroxyprogesterone Capronate|Intramuscular injection 250 mg
15845699|NCT04077827|Drug|Propofol|Patients will be divided into 2 groups. The TIVA group (N = 23) will be administrated intravenous anesthesia (propofol-remifentanil), while to the DES group (N = 23) volatile anesthetics (desflurane-remifentanil)
15845700|NCT04077814|Device|Foot Drop Stimulatio - Neuro Orthosis|Walkaide is the Foot drop stimulator (FDS) on the peroneal nerve provides active dorsiflexion of muscle during the swing phase of gait.
15845701|NCT04077814|Device|Transcranial direct brain stimulation|Transcranial direct brain stimulation on motor cortex
15845702|NCT04077801|Diagnostic Test|diagnostic test|diagnostic test
15845703|NCT04077788|Other|muscle energy technique|"Muscle energy technique:
~Application of MET for bone of pelvis:
~I) Pubis:
~Cranial Os pubis.
~Caudal os pubis.
~II) ileum:
~Anterior ileum.
~Posterior ileum.
~External Rotation (In flare) Lesion.
~Internal Rotation (Out flare) Lesion.
~III) sacrum:
~Forward torsion of sacrum.
~Backward torsion of sacrum.
~Muscle energy technique for specific muscles of pelvis and spine:
~Stretch of the Psoas Major.
~Stretch of the paravertebral muscle.
~Stretch of the piriforms."
15845704|NCT04077775|Diagnostic Test|assesment|assesment
15845705|NCT04077762|Procedure|Radial Access|Radial Access
15845706|NCT04077762|Procedure|State-of-the-art femoral access with 18 gauge needle|State-of-the-art femoral access with 18 gauge needle
15845707|NCT04077762|Procedure|State-of-the-art femoral access with 21 gauge needle|State-of-the-art femoral access with 21 gauge needle. For patients randomized to micropuncture (21G) the micropuncture wire must be advanced under fluoroscopy to avoid inadvertent wiring of side-branches.
15845708|NCT04077749|Biological|Femdophilus probiotic|Lactobacillus rhamnosus (GR-1®) and reuteri (RC-14®) species, which is offered as an over the counter probiotic capsule sold under the brand name of Femdophilus dissolved in 50 mL normal saline at room temperature.
15845709|NCT04077749|Other|Normal Saline|50 mL normal saline at room temperature
15845710|NCT04077736|Drug|Interleukin-2|low dose interleukin-2 injected subcutaneously, at a dose of 1 million IU five days per week for 4 weeks (day1-5, 8-12, 15-19, 22-26) and then once a week for 8 weeks (day33, 40, 47, 54, 61, 68, 75, 82). Then all patients were followed up for 3 months
15845715|NCT04077710|Radiation|Radioactive Iodine-125 Seeds Implantation|The radioactive Iodine-125 seed can release low dose of irradiation persistently which kills tumors cell and causes less damage to normal tissue at the same time. The treatment was performed under CT monitoring. 3D-printing template includes information on the path of the implantation needle, characteristics of the surface of the therapy area of the patient, and positioning and orientation effects which can make the operation more accurate.
15845716|NCT04077697|Diagnostic Test|RT-PCR for influenza|influenza real time polymerase chain reaction (RT-PCR) from a nasopharyngeal swab or bronchoalveolar lavage (BAL) fluid.
15845717|NCT04077684|Drug|Interleukin-2|IL2 (0.2 MIU, 0.5 MIU or 1 MIU) : placebo = 1:1:1:1
15845718|NCT04077671|Biological|CHF6467 active|CHF6467, is mutated form of the human Nerve Growth Factor (NGF).
15845719|NCT04077658|Behavioral|HeartMath|HeartMath is a program where individuals learn heart rate variability biofeedback. Essentially, they learn breathing exercises that reduce their heart rate. The HeartMath program will be administered via an application on the smartphone and ear monitor.
15845720|NCT04077658|Behavioral|Waitlist Control|Standard of Care Migraine Treatment
15845721|NCT04077645|Behavioral|Sun salutations|This group will be asked to participate in 25 minutes of low-to-moderate intensity Yoga. This acute session will include engaging in sun salutations, breathing exercises and relaxation. Sun salutations involves performing 10 postures in a particular sequence, and then repeating that sequence. Some of the positions include bending over and touching one's toes, and lying belly-down on the ground and pushing up from ground while arching backwards. The activity will begin as a low intensity activity for the first 5 minutes, and the intensity will be gradually increased. Participants' heart rate will be measured before and after the intervention. The intervention will be delivered by a video displayed on a tablet device. An orientation session in the beginning will familiarize participants with the activity.
15845722|NCT04077645|Behavioral|Aerobic exercise|This group will be asked to walk on the treadmill for the same amount of time (i.e. 25 minutes) at a moderate intensity (50-70% of their maximum heart rate). Participants will receive an initial 5-minute orientation and then begin at a self-selected speed for the first 5 minutes. Heart rate will be measured and monitored by an undergraduate research assistant. Speed will be increased after 5 minutes if participants have not reached the moderate zone. If participants still have not reached the target heart rate zone by the 10-min mark, the incline of the treadmill will be increased by a 5% grade until the zone is reached.
15845723|NCT04077645|Behavioral|Seated rest|This group will be watching educational videos for the same amount of time as the intervention groups. An orientation session of 5 minutes will be held in the beginning. Participants will be watching videos on general health related topics, such as healthy eating, while being seated in a quiet room, free of distractions.
15845724|NCT04077632|Device|Transcranial direct current stimulation|tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).Technique based on the application of weak, direct electrical current to the brain through relatively large electrodes that are placed over the scalp, in which anodal and cathodal stimulation increases and decreases cortical excitability, respectively.
15845725|NCT04077619|Behavioral|Modern pain neuroscience approach|Modern pain neuroscience approach. The modern pain neuroscience approach includes 3 sessions (1 group and 2 individual sessions) of therapeutic pain neuroscience education followed by 15 individual sessions of dynamic and functional cognition-targeted exercise therapy and stress management techniques. In addition, participants will be instructed to perform a daily set of home exercises. The exercises will be performed in a time-contingent way. The 18 sessions will be spread over a period of 16 weeks.
15845726|NCT04077619|Behavioral|Usual care physiotherapy|Usual care evidence-based physiotherapy The usual care evidence-based physiotherapy includes 3 sessions (1 group and 2 individual sessions) of neck school followed by 15 individual sessions of graded and active exercise therapy focusing on strength, flexibility, endurance, and ergonomic principles. In addition, participants will be instructed to perform a daily set of home exercises. The exercises will be performed in a symptom-contingent way. The 18 sessions will be spread over a period of 16 weeks.
15845727|NCT04077606|Other|ceramo-metallic crown prepartion|tooth will be prepared to receive ceramo-metallic crowns
15845728|NCT04077606|Other|full anatomical monolithic zirconia crown|tooth will be prepared to receive monolithic zirconia crowns
15845729|NCT04077593|Device|RRate Mobile app|Test respiratory rate with RRate application
15845730|NCT04077580|Drug|Methenamine Hippurate 1000 MG|Methenamine and placebo is taken 1 tablet morning and evening for 180 days
15845731|NCT04077567|Drug|TS-152|30mg,80mg
15845732|NCT04077554|Genetic|gene expression|determination of VEGF gene expression, VEGF gene polymorphism and serum leptin concentration
15845733|NCT04077541|Behavioral|internet platform|The trauma care bundles combined with the internet platform.
15845734|NCT04077515|Drug|Sirolimus(0.8mg/m2)|The initial use of sirolimus is 0.8mg/m2 administered twice daily.After two weeks of taking the drug, blood concentrations are measured and adjusted appropriately to maintain the targeted blood concentration.
15845986|NCT04075292|Drug|Rituximab|Rituximab: 375 mg/m2 IV infusion on Day 1 of Cycle 1. 500 mg/m2 IV infusion on Day 1 for each of subsequent cycles (Cycles 2-6)
15845735|NCT04077515|Drug|Sirolimus(0.7mg/m2)|The initial use of sirolimus is 0.7mg/m2 administered twice daily.After two weeks of taking the drug, blood concentrations are measured and adjusted appropriately to maintain the targeted blood concentration.
15845736|NCT04077502|Device|Repetitive Transcranial Magnetic Stimulation|Repetitive Transcranial Magnetic Stimulation
15845737|NCT04077489|Procedure|cataract surgery|To measure the MT in congenital cataracts before and after the cataract extraction with IOL implantation surgery
15845738|NCT04077476|Behavioral|Online Yoga + Facebook|Each week, the research team will post a prompt for discussion to encourage participation. Prompts will be developed in the beginning stages of the project based on data from the current R34 study and with guidance from consultant Waibel. Participants will be encouraged to post about their experiences with the intervention and stillbirth (emotional support), share resources, (informational support), and offer feedback and advice (appraisal support). Participants will not be required to adhere to certain criteria for engagement (e.g., number of posts, etc.), other than their weekly log in. This is to account for different types of engagement when using social networking as a means of support (e.g., posting, just reading); the benefits of each type of engagement are person-specific. The page will be moderated by members of the research team, who will post prompts and ensure content is updated and appropriate. No members can be added to the group without approval from the research team.
15845739|NCT04077476|Behavioral|Online Yoga|Participants will complete a series of videos covering basic poses and safety techniques, tracked using the Wistia plugin software. Once complete, they will be able to access the library of pre-selected classes (range in time from 10-90 minutes). Participants will be asked to complete at least 60 minutes of yoga per week; participants may choose any classes to yield 60 minutes. Preliminary data from the current R34 study suggests 60 minutes is a feasible amount of time for yoga participation. There is no upper limit to the number of minutes participants can complete.
15845740|NCT04077463|Drug|Lazertinib|Lazertinib will be administered orally.
15845741|NCT04077463|Drug|Amivantamab|Amivantamab will be administered as an intravenous (IV) infusion.
15845742|NCT04077463|Drug|Carboplatin|Carboplatin will be administered as IV infusion.
15845743|NCT04077463|Drug|Pemetrexed|Pemetrexed will be administered as IV infusion.
15845744|NCT04077450|Behavioral|Online Heart-Focused Breathing Intervention|Participants will receive an online standardized HeartMath© heart-focused breathing intervention.
15845745|NCT04077437|Behavioral|Behavioral: Psychotherapy|Standardized non-directive psychotherapy performed by therapist team.
15845746|NCT04077437|Drug|MDMA|Administration of 80 to 120 mg MDMA during three sessions of MDMA-assisted psychotherapy, followed by a supplemental half-dose of 40 or 60 mg MDMA offered 1.5 to 2 hrs after the initial dose, respectively.
15845747|NCT04077437|Drug|Placebo|Administration of placebo during three sessions of MDMA-assisted psychotherapy.
15845748|NCT04077424|Biological|Fluzone-High Dose Quadrivalent|Seasonal influenza vaccination with FDA approved vaccines for this age group.
15845749|NCT04077424|Biological|Fluad|Adjuvanted (MF59) inactivated influenza vaccine
15845750|NCT04077424|Biological|Flublock|Recombinant hemagglutinin vaccine
15845751|NCT04077411|Other|Observational|This is an observational study with no interventions.
15845752|NCT04077398|Drug|Ropivacaine 0.5% Injectable Solution|There will be two groups, in order to compare two different sets of volumes with the same amount of drug. we will try to identify if it is better one volume over the other in terms of pain control and consume of opioids, as well the presence or absence of motor weakness.
15845753|NCT04077385|Behavioral|Retrieval-extinction (R-E) Training|The retrieval-extinction (R-E) training intervention will occur on two consecutive days and consist of (a) retrieval of high calorie food cue-reward associative memories and (b) 60-min extinction training for high calorie foods. During the 5-min of retrieval, participants will observe 30 high calorie food images (e.g., cakes, cookies, muffins, hamburgers, french fries, potato chips, pizza). Images will be presented in E-Prime for 8-s each (2-s delay between images). After the 5-min of retrieval and a 10-min rest period, participants will engage in 60-min of extinction training for high calorie foods consisting of 12, 5-min high calorie food cue sequences: 6 image sequences and 6 real food sequences. The real foods will consist of a small portion of high calorie snack foods such as a single M&M or potato chip.
15845754|NCT04077385|Behavioral|Extinction Training|The extinction control group will engage in two consecutive days of intervention consisting of (a) retrieval of memories not associated with high calorie foods and (b) 60-min extinction training for high calorie foods. During the 5-min of retrieval, participants will observe 30 non-food-related neutral images (e.g., office supplies, tools). Images will be presented in E-Prime for 8-s each (2-s delay between images). After the 5-min of retrieval and a 10-min rest period, participants will engage in 60-min of extinction training for high calorie foods consisting of 12, 5-min high calorie food cue sequences: 6 image sequences and 6 real food sequences. The real foods will consist of a small portion of high calorie snack foods such as a single M&M or potato chip. The 60-min extinction training is the same as the extinction training received by participants in the R-E training intervention.
15845755|NCT04077372|Behavioral|Serious Illness Conversation Guide (SICG)|The Serious Illness Conversation Guide (SICG) is a structured communication template designed to provide effective tool in initiating advanced care planning discussion with patients.
15845756|NCT04077372|Behavioral|Quality of Life (QOL) survey|Quality of life survey by questionnaire (FACT-G) given every three months
15845757|NCT04077359|Diagnostic Test|CT|the CT consist of four phases; non-enhanced, corticomedullary, nephrographic and excretory phase.
15845758|NCT04077346|Device|Biostim-5 transcutaneous spinal stimulator|"Transcutaneous spinal stimulation (TcStim): The 5-channel stimulator capable of generating (41) pain-free biphasic rectangular waveform of 0.3- to 1.0-ms pulses with a frequency of 5-10 kHz will be used to stimulate at single or multi-site spinal levels.
~TcStim will be delivered in combination with activity based locomotor training in 5 - 10 minute of stimulation at sub-motor threshold daily (5x/week) for 60 sessions"
15845759|NCT04077346|Other|Transcutaneous Spinal Stimulator + Activity Based Locomotor Training|Participants will receive a combination of Activity-based locomotor training (AB-LT)+TcStim daily (5x/week) for 60 sessions and will consist of a minimum of 55-60 min on the TM for facilitated standing/stepping followed by 30 min of activities off TM in sitting, standing, or stepping.
15845987|NCT04075292|Drug|Chlorambucil|Chlorambucil: 0.5 mg/kg body weight orally on Day 1 and Day 15 of Cycles 1-6
15845760|NCT04077333|Procedure|Minimal Invasive surfactant administration|Participants enrolled spontaneously breathing preterm infants born between 26.1 and 31.9 weeks' gestational age with signs of respiratory distress syndrome. Preterm infants of the MISA (Minimal invasive surfactant administration) group were assigned to receive surfactant (Calf pulmonary surfactant, Double-Crane Pharmaceutical Co., China) via a 5Fr nasogastric tube with an ophthalmic surgery straight forceps during CPAP/NIPPV-assisted spontaneous breathing.
15845761|NCT04077320|Behavioral|Memory Self-Efficacy Training|The intervention will consist of a six-week cognitive behavioral intervention integrating the four pillars of self-efficacy, Mastery, Social Modeling, Coaching, and Physiological Responses (West et al. 2008). Each week will comprise of a 1.5 hour session which focuses on an educational component, discussions and active learning practice activities to apply lesson material. Additionally, participants will be given take home exercises to practice outside a classroom setting. The sessions will be conducted in small groups of 4-6 people.
15845762|NCT04077320|Behavioral|General Education|The active control intervention will be a general education class consisting of real world knowledge and factual information on various topics unrelated to memory. This intervention will follow the same format as the memory self-efficacy training arm. One 1.5 hours session every week for 6 weeks, in small groups.
15845763|NCT04077307|Drug|Karonudib|Dose escalation of administration with Karonudib. Three different dose cohorts are planned.
15845764|NCT04077294|Other|Cardiac risk stratification using preoperative BNP measurement, followed by postoperative cardiac monitoring|Patients undergoing non-cardiac surgery risk stratified using BNP measurements according to CCS guidelines.
15845765|NCT04077294|Other|Use of traditional perioperative cardiac risk stratification only|Patients undergoing non-cardiac surgery risk stratified using tools other than BNP measurement such as revised cardiac risk index (RCRI).
15845766|NCT04077281|Other|Medication Coordinated care|"Clinical Pharmacology & Toxicology consult
~CPT team completes detailed circle of care communication
~Telemedicine followup by CPT team (approximately 48 hrs post-discharge & 1 week to1 month post-discharge)"
15845767|NCT04077268|Other|GOS-E|Call at 7 days, patients add a brain trauma to know their sequeals
15845768|NCT04077255|Drug|Anti-EGFR antibody in combination with weekly paclitaxel|Intravenous GC-1118 in combination with weekly paclitaxel for EGFR-amplified cancer cancers as a second-line therapy
15845769|NCT04077242|Diagnostic Test|"Hysteroscopic Fallopian tube assessment using the Parryscope technique"|A small amount of air is introduced into the iv tubing by inverting the drip chamber to create air bubbles. When air enters the uterine cavity, a single large air bubble or stream of air bubbles traversing the ostia is considered indicative of tubal patency. At least 10 seconds of intracavitary evaluation is typically performed before air bubble entry to allow pressure equilibration if a hydrosalpinx is present [10]. At least 30 seconds of observation per ostia is performed if patency is not observed.
15845770|NCT04077242|Diagnostic Test|"Hysteroscopic Fallopian tube assessment using the Tubal flow technique"|"a positive flow is defined as the observation of saline directly traversing the ostia, endometrial structures floating toward the ostia, or air bubbles traversing the ostia."
15845771|NCT04077229|Behavioral|Intervention arm: Text Message Intervention|Participants will receive a combination of messages promoting both psychological well-being and education /support around health behavior adherence, such as physical activity or diet. In the first part of the study, participants will receive 28 fixed text messages that alternate between physical activity and PP (Positive Psychology) messages. In the second part of the study, participants will first receive a set of 14 pre-selected daily messages that contain a broad range of attributes to allow sufficient participant feedback to clearly identify preferences. After the first 14 messages, new messages will be selected based on the prior preferences of participants.
15845772|NCT04077216|Dietary Supplement|Extra Virgin Olive Oil (EVOO)|This study used the FDA approved Doña Elena Extra virgin olive oil, which is readily available in local supermarkets. Its free acidity expressed as oleic acid was found to be 0.26%, comparable with the International food standards.15
15845773|NCT04077203|Behavioral|Biofeedback / No biofeedback|Biofeedback / No biofeedback
15845774|NCT04077190|Device|Adipose-derived stem cells|5cc adipose derived stem cells.
15845775|NCT04077190|Device|cortisone injection|cortisone injection
15845776|NCT04077177|Behavioral|Male Athlete Body Project|Participants who meet eligibility criteria and consent to the study will be randomized to one of two conditions: intervention condition (i.e., Male Athlete Body Project) or an assessment only control condition. The intervention groups will take place at IIT. Participants who accept randomization to condition will complete baseline questionnaires after randomization (immediately prior to Session 1 in the intervention condition and after being randomized to the assessment only control condition). Questionnaires will be repeated immediately post-intervention (intervention condition)/after a 3-week interval (control). All participants will be asked to complete the questionnaires again, 4 weeks after the previous round of questionnaires. The 3, 80-minute group sessions will be separated by 1 week.
15845777|NCT04077164|Other|No intervention, observational only.|No intervention, this study will use self-report information regarding health, social, and behavioral factors for each member of the couple.
15845778|NCT04077151|Behavioral|PrEP Demonstration Project|In phase 2, a culturally, developmentally, and gender-affirmative intervention to increase uptake of and adherence to PrEP among TW and TM youth will be developed by incorporates the PK data from phase 1 and data gathered from focus groups and in-depth interviews with young transgender women and transgender men. During phase 3, this intervention will be given to the experimental arm and tested versus a standard-of-care control group.
15845779|NCT04077125|Drug|Rifaximin|to investigate changes in cerebral, splanchnic hemodynamics and endothelial function in cirrhotic patients with MHE after 15 days of rifaximin therapy (1200 mg/d)
15845780|NCT04077112|Behavioral|Parent Child Interaction Therapy|Behavioral parent training program targeting parent-child relationship
15845807|NCT04076826|Drug|Propofol or Midazolam|Propofol and/or Midazolam will be used according to Hospital guidelines to maintain sedation as per Richmond Agitation-Sedation Scale (RASS) sedation range specified by the treating clinician.
15845808|NCT04076826|Diagnostic Test|Blood sampling|In all participants, we will collect blood samples for measurement of neuronal and systemic biomarkers of inflammation at randomization (baseline), at day 1, day 2 and day 3 after randomization.
15845782|NCT04077086|Device|Spectacles|Intervention group children in middle school Years 1 and 2 will receive spectacles at the beginning of the academic year (September 2021). Assuming that the relevant effects of treatment (glasses wear) on the main study outcome are complete once examinations determining high school attendance are finished at the end of Middle School Year 3, Intervention participants will have undergone either 22 months (September 2021 to July 2023 for those recruited in Year 2) or 34 months (September 2021 to July 2024 for those recruited in Year 1) of treatment by the endpoint of the trial.
15845783|NCT04077073|Device|ReIn-Hand|ReIn-Hand assists the hand opening
15845784|NCT04077073|Device|Robot|Robot supports the shoulder load
15845785|NCT04077060|Diagnostic Test|NIPT|"Women randomized in the intervention group will be offered cfDNA screening, along with an early detailed anatomy scan, including nuchal measurement, at 11-13 weeks of gestation. cfDNA analysis will include a simultaneous microarray-based assay of non-polymorphic (chromosomes 13, 18, 21, X and Y) and polymorphic loci to estimate chromosome proportion and fetal fraction. NIPT will be performed at the time of randomization or after if gestational age at randomization < 9 6/7 weeks of gestation.
~Women in both groups will be given oral counseling by obstetricians and will be counseled about test procedures, reporting time, test sensitivity and specificity, and the necessity to confirm abnormal screening results with invasive testing."
15845786|NCT04077060|Diagnostic Test|combined screening|Control group includes the standard of care. In our department, first-trimester risk assessment is performed routinely at 11-13 weeks of gestation by FTCS as per standard of care. FTCS includes crown-rump length, NT measurements, and a detailed ultrasound examination based on ISUOG guidelines. All operators who perform this examination are certified by the UK Fetal Medicine Foundation (FMF). A specific risk for aneuploidy is not calculated if NT measurement is >3.5 mm or if fetal anomaly is identified. These cases are deemed to be at a very high risk for chromosomal abnormalities and are offered invasive testing.
15845787|NCT04077047|Other|iEngage (tentative title)|The intervention is a network-based, social support intervention to improve ALWH retention in HIV care and ART adherence. The specific intervention will be developed during Aim 2 of the study and uses qualitative findings, along with data from Aim 1, to develop an interventions that integrates participant feedback and borrows components from two existing interventions: Masivukeni and LIFECommunity.
15845788|NCT04077034|Dietary Supplement|Probiotic Formula Bacillus subtilis DE111®|Probiotic Formula Bacillus subtilis DE111®, 1 billion colony forming units (CFU) per day for 8 weeks
15845789|NCT04077034|Dietary Supplement|Placebo comparator|Placebo comparator, once a day for 8 weeks
15845790|NCT04077021|Drug|CCW702|Investigational immunotherapy for prostate cancer
15845791|NCT04077008|Procedure|unilateral drainage of Bilaterally Obstructed Kidneys|drainage of obsructed kidneys by PCN or jj
15845792|NCT04077008|Procedure|bilateral drainage of Bilaterally Obstructed Kidneys|drainage of obsructed kidneys by PCN or jj
15845793|NCT04076995|Other|Water Intake|Increased water intake during the 11 h protocol
15845794|NCT04076982|Dietary Supplement|mung bean protein|Participants were instructed to consume the test foods in the morning hours and to keep a record of the days the foods were consumed on a study calendar which was returned to investigators at the final visit and used to track protocol adherence.
15845795|NCT04076982|Other|control biscuit|Participants were instructed to consume the test foods in the morning hours and to keep a record of the days the foods were consumed on a study calendar which was returned to investigators at the final visit and used to track protocol adherence.
15845796|NCT04076969|Behavioral|Integrated educational session|The educational session aimed to correct the pregnant women diatery habits and enhance the degree of compliance to the iron treatment and follow up instruction.
15845797|NCT04076956|Device|Anterior Cruciate Ligament Reconstruction|Reconstruction of the Anterior Cruciate Ligament using an interference screw
15845798|NCT04076943|Drug|Roxadustat (FG-4592)|Roxadustat will be dosed orally three times a week.
15845799|NCT04076930|Drug|angiotensin-converting enzyme inhibitor (ACEI) and angiotensin receptor blocker (ARB)|The use of ACEI/ARB within a 90-day after the date of PD initiation (exposure ascertainment window period).
15845800|NCT04076904|Diagnostic Test|transvaginal us with 2D and 3D SHG|transvaginal us is made to all women with SHG
15845801|NCT04076891|Drug|RZL-012|The dosing regimen will be a single dose treatment injection of RZL-012 in multiple sites.
15845802|NCT04076878|Device|Mollii|The Mollii method is provided in a tight fitting, whole body suit with multiple electrodes that can be set individually. The Mollii method uses low frequencies and low intensities that evokes sensory input but does not directly elicit muscle contractions. The theoretical background of this treatment method primarily refers to the concept of reciprocal inhibition, i.e. that sensory input from a muscle may inhibit the activation of an antagonistic muscle through the activation of the disynaptic reciprocal Ia inhibitory pathway.
15845803|NCT04076865|Drug|EMLA (lidocaine) +Itch (Histamine and cowhage)|"Cutaneous anaesthesia: will be topically induced by using EMLA cream 5%, a local anaesthetic cream consisting of equal parts of lidocaine and prilocaine (1g contains 25 mg of lidocaine and 25 mg of prilocaine, AstraZeneca A/S, Albertslund, Denmark).
~Histamine: To deliver histamine, standard allergy skin prick test (SPT) lancets are applied.
~Cowhage: Cowhage spicules are 1-2 mm in length and have diameter of 1-3 um at their tip, once inserted into the epidermis, the spicules evoke a moderate sensation of itch and to a lesser extent sensations of burning and stinging pain."
15845804|NCT04076852|Other|Administration of questionnaires|"According to clinical practice, the following questionnaires are administered:
~Y-GTSS
~Y-BOCS or cY-BOCS"
15845805|NCT04076839|Behavioral|Goal Management Training|Goal Management Therapy is a structured, short-term, present-oriented cognitive remediation program with emphasis on mindfulness and practice in planning and completion of goal-oriented behaviors. The primary objective of GMT is to train patients to interrupt ongoing behavior through the resumption of executive control in order to define goal hierarchies and monitor performance in achieving goals. Sessions include instructional material, interactive tasks, discussion of patients' real-life deficits, and homework assignments.
15845806|NCT04076826|Drug|Dexmedetomidine|Dexmedetomidine infusion will be commenced in accordance with the hospital's local sedation protocol, without a loading dose, at a rate of 0.1 - 1.4 mcg/kg/hour to maintain sedation as per Richmond Agitation-Sedation Scale (RASS) sedation range specified by the treating clinician. Infusion will be continued until sedation is no longer clinically indicated up to a maximum of 7 days after enrolment.
15845809|NCT04076800|Procedure|Acupuncture|Acupuncture treatment will include use of somatic points (SP6; ST36; KI3; CV4; CV12; TE5; LI4; LI11; YinTang; ST28; BL23; BL22; BL20; BL13) and auricular points (most tender point on palpation with pressure feelers of 400 gr on Stomach, Endocrine, Spleen, Kidney, Hungry, Shen man and Pancreas auricular points).
15845810|NCT04076787|Drug|Sunitinib|patients who received sunitinib as first line therapy for mRCC
15845811|NCT04076774|Device|Wondaleaf Female Condom|Wondaleaf: Wondaleaf is an ultra thin (of 0.02 mm) polyurethane female/male condom (16x8cm) that has folded extended adhesive shields (front 18x18cm, back 18x10cm), which at unfolding covers the entire external genitalia to prevent direct skin contact and exchange of body fluid between sexual partners during intercourse. Insertion of the condom body into the vagina is through use of a small medical grade cotton tissue packed inside the foil package. This is inserted into the end of the condom body and used to push the condom into the vagina. Each condom is individually packaged without prior lubrication. However, lubricant is expected to be used at donning the condom and during sexual intercourse. The lubricant will be supplied in separate packets together with the condom. Unlike latex, polyurethane condoms are unlikely to cause any allergic reaction and are much stronger than conventional latex condoms
15845812|NCT04076774|Device|FC2 Female Condom|FC2: The FC2 is a second-generation female condom manufactured by the Female Health Company (Chicago, IL). The FC2 has US FDA approval and has been granted the CE Mark (Conformité Européenne) of the European Union. The FC2 is the only female condom that has been pre-qualified by the World Health Organisation. The device is similar in design to the FC1, but is made from a synthetic polymer (nitrile) film that is softer and more elastic than the polyurethane of the earlier device. The condom is designed as a loose-fitting pouch that lines the vagina. It has two flexible rings. The outer ring at the open end is rolled from the nitrile material. The outer ring remains outside the vagina and covers the external genitalia during intercourse. An internal polyurethane ring is removable and serves as the insertion mechanism and anchors the device within the vagina. FC2 measures 180mm in length and 80mm in lay-flat width. The device is pre-lubricated with dimethicone.
15845814|NCT04076748|Drug|Sufentanil|The intervention is intranasal Sufentanil adminstration, then IV morphine as soon as possible.
15845815|NCT04076748|Drug|EMONO|In the control group, patients will receive EMONO then IV morphine as soon as possible.
15845816|NCT04076735|Procedure|Distal femoral replacement|The distal portion of the femur (up to two thirds) is excised and replaced by a endoprosthesis incorporating a hinged total knee replacement.
15845817|NCT04076735|Procedure|Surgical Fixation (ORIF)|A trained orthopaedic surgeon uses open or minimally invasive reduction techniques and achieves stable fixation with internal fixation devices (plates/screws or intramedullary nail) to restore structural integrity and alignment of the distal femur
15845818|NCT04076722|Behavioral|Stress reactivity stimuli|An evaluated speech task delivered to participants after baseline testing.
15845819|NCT04076709|Procedure|goal directed anaesthesia|Deep neuromuscular blockade (PTC 1-2) Nociception level index (NOL) target 10-25
15845820|NCT04076696|Device|Scatter corrected s-DCT|All patients will have a breath held s-DCT scan in an anterior-posterior direction
15845821|NCT04076683|Device|Algodrep|Algorithm computing the volume of blood to be transfused and the interval between apheresis which are necessary to maintain an individual objective of HbS percentage.
15845822|NCT04076670|Other|Psychological intervention for family caregivers of patients at the end of life|The intervention protocol is a structured programme within the framework of counselling, that aims to reduce anxiety and depression symptoms, as well as symptoms of burden (overburden).
15845823|NCT04076657|Behavioral|Brock String Therapy|Oculomotor exercise to improve binocular vision function
15845824|NCT04076657|Behavioral|Standard of Care|patient engages in normal behavior to manage vision issues, such as breaks with reading and screen use
15845825|NCT04076644|Device|TMS treatment|TMS using either a standard 10hz 20min or 3 min theta burst protocol
15845826|NCT04076618|Device|Vest|Weighted Vest worn > or = 8 hours per day
15845827|NCT04076618|Behavioral|Resistance Exercise Training|Structured exercise training 3 days a week
15845828|NCT04076618|Behavioral|weight loss program|a 24-week intensive phase (with weekly dietary classes) followed by a 27-week transition phase (with biweekly dietary classes)
15845829|NCT04076579|Drug|Olaparib|Olaparib taken by mouth twice daily
15845830|NCT04076579|Drug|Trabectedin|Trabectedin administered intravenously (IV) every 21 days
15845831|NCT04076566|Device|alfapump system|active implantable device for treatment of malignant ascites
15845832|NCT04076553|Behavioral|CBT|Participants will complete 12 sessions of CBT
15845833|NCT04076553|Behavioral|ICT|"Participants will complete 4 weeks of daily inhibitory control trainings and booster ICT trainings following CBT treatment in weeks 5-12"
15845834|NCT04076540|Drug|AZD4041|Administration by Oral syringe
15845835|NCT04076540|Drug|Placebo|Administration by Oral syringe
15845836|NCT04076527|Drug|UDCA|Routine data is collected for UDCA therapy.
15845837|NCT04076527|Drug|Ocaliva|Routine data is collected for OCA therapy.
15845838|NCT04076514|Procedure|central neck dissection|dissection of central cervical lymph node grope in low grade papillary thyroid cancer
15845839|NCT04076501|Procedure|Oxygen application|Oxygen application Supplemental oxygen via mask
15845840|NCT04076501|Procedure|Sham room air|Room air applied via mask
15845841|NCT04076488|Other|Dividat Fit|tablet based, remote assisted home-training
15845842|NCT04076475|Device|neuromuscular electrical stimulation|Participants will receive muscular electrical stimulation on quadriceps muscle and abdominal muscles for 30 min/day for 10 days
15845843|NCT04076462|Drug|CAM2029 (octreotide subcutaneous depot)|Octreotide subcutaneous depot for monthly injections in acromegaly patients
15845844|NCT04076462|Drug|Matching placebo|Matching placebo for CAM2029
15845845|NCT04076436|Other|Drug: Intravenous fosfomycin|"Patients will be visited on days 1 (Day of the urine and blood culture taking), 2, 5, 7, 14, on the test of cure and on day 30.
~Visit on day 1: First day of treatment. Basal data collection.
~Visit on day 2: Blood collection to fosfomycin levels calculation.
~Visits on days 5, 7, 14, on the test of cure (day 21): Clinical evolution data, Urocultures and Adverse effects.
~Visit on day 30: Assess mortality"
15845846|NCT04076436|Other|Drug: Intravenous quinolone or beta-lactam|"Patients will be visited on days 1 (Day of the urine and blood culture taking), 5, 7, 14, on the test of cure and on day 30.
~Visit on day 1: First day of treatment. Basal data collection.
~Visits on days 5, 7, 14, on the test of cure (day 21): Clinical evolution data, Urocultures and Adverse effects.
~Visit on day 30: Assess mortality"
15845847|NCT04076423|Drug|Dual Therapy|DTG + 3TC
15845848|NCT04076423|Drug|Triple therapy|BIC / FTC / TAF
15845849|NCT04076410|Device|Z1 lens|CE marked device
15845850|NCT04076410|Device|Experimental Lens 1|CE marked device
15845851|NCT04076410|Device|Experimental Lens 2|CE marked device
15845852|NCT04076410|Device|Experimental Lens 3|CE marked device
15845853|NCT04076410|Device|Experimental Lens 4|CE marked device
15845854|NCT04076397|Procedure|autologous transplant reinjection|The patient is placed under loco-regional anesthesia. After sterilization of the upper limb and abdomen, the fat is removed at a fold by micro-incision by the Coleman method. The fat is decanted and micro-reinjected into the pulp of the patient's finger with 2 or 3 punctiform incisions. The quantity of fat injected is 2 to 3 mL. Incision of the abdomen and fingers is closed by points at monocryl 4/0. Finally, a fatty dressing is performed on the finger. Patients will benefit from nursing care every 2 days
15845855|NCT04076397|Other|desensitization|Patients will have to stimulate the pulp of your finger on a daily basis
15845856|NCT04076384|Behavioral|Guided Self-Determination|Structured team-based consultations
15845857|NCT04076384|Behavioral|Standard care|Standard consultations
15845858|NCT04076371|Drug|olanzapine-sertraline combination|the patient was prescribed low-dose olanzapine (7.5-10mg/day) combined with low-dose sertraline (50-100mg/day)
15845859|NCT04076371|Drug|only olanzapine|the patient was prescribed moderate to severity dose of olanzapine (12.5-20mg/day)
15845860|NCT04076371|Drug|risperidone-sertraline combination|the patient was prescribed low-dose risperidone (2-3.5mg/day) combined with low-dose sertraline (50-100mg/day)
15845861|NCT04076371|Drug|only risperidone|the patient was prescribed moderate to severity dose of risperidone (4-6mg/day)
15845862|NCT04076371|Drug|paliperidone-sertraline combination|the patient was prescribed low-dose paliperidone (3-4.5mg/day) combined with low-dose sertraline (50-100mg/day)
15845863|NCT04076371|Drug|only paliperidone|the patient was prescribed moderate to severity dose of paliperidone (6-9mg/day)
15845864|NCT04076371|Drug|ziprasidone-sertraline combination|the patient was prescribed low-dose ziprasidone (60-100mg/day) combined with low-dose sertraline (50-100mg/day)
15845865|NCT04076371|Drug|only ziprasidone|the patient was prescribed moderate to severity dose of ziprasidone (120-160mg/day)
15845866|NCT04076358|Behavioral|Tab-CBI|Participants receive a tablet preloaded with Tab-CBI application and an accelerometer.
15845867|NCT04076345|Diagnostic Test|Prespesin assay on PATHFAST analyser|"Collection of parental non-opposition by the doctor taking care of the child. Addition of an additional 500μl tube to the usual blood sampling as part of the protocol for the management of children under 3 months of age with fever. This blood test contains CRP, PCT, NFS, Hemoculture.
~There is no additional venipuncture. This blood sample is taken by the nurse after parental non-opposition. Transfer of the sample to the laboratory. In the laboratory, centrifugation of the sample, taking the plasma alone which will be frozen.
~Delayed assay of presepsin, in series, after thawing of samples. Collection of data and analyzes by the principal investigator in collaboration with the statistician methodologist.
~The immunoassay of presepsin with PATHFAST is based on chemiluminescence."
15845868|NCT04076332|Other|Decision aid|Decision aid is a tool that helps patients become involved in decision making on choosing treatment plans. Decision aid provides information about the options and outcomes, and by clarifying personal values.
15845869|NCT04076319|Behavioral|CAPABLE: Community Aging in Place-Advancing Better Living for Elders|"CAPABLE is a client-directed home-based intervention that consists of time-limited services from an occupational therapist, a nurse, and a handyman working collaboratively with the older adult client. In most cases, the OT makes 6 visits, the RN makes 4 visits, and a handyman makes 1 to 2 visits to make any modifications to a person's home during a 6-month period. The first visits for the OT and RN are usually 90 minutes each and the later ones are usually an hour each. Visits are spaced to enable older adults to practice new strategies learned in the previous visit. There should be a clear conclusion/graduation, with the older adult understanding how to use their new skills and apply them to future situations."
15845870|NCT04076306|Other|iSTEP exercise testing|iSTEP 10 minute step test, up and down on a commercial standard 3-height adjustable step Undertaking the 10m-MSWT 20-30 minutes Procedure takes place on testing track at Great Ormond Street Hospital; a 5 minute walk from the Haemophilia Centre. One of the research team accompanies the family with child to the track and will accompany them back to the Centre once testing is finished. Muscle Myometry 10 minutes, carried out by one of the research team at the end of the physiotherapy clinical assessment in the Haemophilia Centre. Wearing of accelerometer (activity/ step counter)7 days Device will be set up and provided at the end of the testing on the day of attendance at clinic. They will be instructed to wear this throughout the week at home when they are awake (at least 8 hours). Haemophilia Joint Health Score (HJHS) - a standardised outcome measure of joint health in people with Haemophilia, undertaken by the Clinical Specialist Physiotherapists in Haemophilia.
15845871|NCT04076293|Drug|HM15912|The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).
15845872|NCT04076293|Drug|Placebo|The study will be conducted in approximately 5 sequential dosing cohorts, enrolling 8 subjects per cohort. Subjects will be randomized to HM15912 or placebo in a ratio of 6:2 (6 active, 2 placebo).
15845873|NCT04076280|Behavioral|Sodium Watcher Program-Hypertension|The Sodium Watcher Program -Hypertension intervention consists of 14 weeks of education [4 weekly education sessions (45 minutes)followed by 5 bi-weekly sessions 5-20 minutes] that will be held at the dyads' preferred time delivered to their homes using a video conferencing program through an iPad.
15845874|NCT04076280|Behavioral|Usual Care|Participants in the usual care group receive their routine medical and nursing care for hypertension that consists of a recommendation to follow a sodium restricted diet and take medications as ordered. Usual care consists of recommendations to follow a sodium restricted diet, but without explicit skills training including instructions on gradual adaptation to sodium restricted diet, follow-up of progress or provision of monitoring.
15845875|NCT04076267|Other|Tool assessing symptoms validation|Comparison between 2 tools evaluating the symptoms of patients with advanced cancer: the ESAS12-F and the EORTC QLQ C30 to assess if the ESAS12-F well evaluates the symptoms and if it is easy to complete. The objective is to validate the ESAS12-F, which is easier and shorter than the well validated EORTC QLQ C30
15845876|NCT04076254|Drug|Albumins|albumin 5%
15845877|NCT04076254|Drug|Fluid|Ringer Lactate
15845878|NCT04076241|Other|Osteopathic manipulative treatment|The investigators applied six different OMT techniques including rib raising, diaphragm release, suboccipital decompression, first rib mobilization, mediastinum mobilization and thoracic inlet myofascial release. Rib raising is used to increase the mobility of the rib cage and to reduce vasoconstriction by regulating sympathetic tone. Diaphragm release is used to increase diaphragm movement. Suboccipital decompression involves traction of the base of the skull. We aim to improve respiration with mobilization of the first rib which is associated with sternum, sympathetic truncus and important vascular structures. Thoracic inlet is an important structure resisting intrathoracic pressure changes during respiration. Finally, the goal of the mediastinum mobilization is to increase the mobility of the rib cage by providing relaxation in the tension of the facial tissues.
15845879|NCT04076241|Other|Yoga respiratory training|Nadishodhana pranayama (Alternate nostril breathing), Ujjayi pranayama (Psychic breath) and Bhramari pranayama (Humming bee breath) were used for the study. Nadishodhana is one of the most common yoga breathing exercises and involves breathing through one nostril while closing the other one. The patients performed 2 sets of 8 breathing cycles with a resting time of 2 minutes between the sets. Ujjayi Pranayama involves soft contraction of laryngeal muscles and the partial closure of the glottis. The patients performed 2 sets of 10 breathing cycles per session with an inspiration:expiration phase as 1:2. Bhramari Pranayama includes a nasal humming sound during exhalation to create slight vibrations on the laryngeal walls, and the inner walls of the nostrils. The patients applied 2 sets of 10 breathing cycles per session with a respiration rate of 3-4/min.
15845880|NCT04076228|Drug|Pembrolizumab|pembrolizumab is a PD-1 inhibitor. Treatment and follow up will be performed at Kiang Wu Hospital in their clinical oncology center. Clinically pathological related information will be recorded.
15845881|NCT04076215|Behavioral|Stressogenic stimulus|Participants will be exposed to an anxiety-provoking stimulus for 15-20 minutes, in a controlled setting
15845882|NCT04076215|Device|Biobeat smart watch and adhesive biosensor patches.|Physiological and biochemical measures will be obtained using the Biobeat smart watch and adhesive biosensor patches.
15845883|NCT04076202|Device|Cementless Vanguard DD RP|Patients treated with the Cementless Vanguard DD RP knee implant
15845884|NCT04076189|Procedure|Endotracheal suctioning|Procedure includes: Endotracheal intubation-Suctioning-Endotracheal intubation again and initiation of positive pressure ventilation
15845885|NCT04076189|Procedure|No endotracheal suctioning|Procedure includes: immediate initiation of positive pressure ventilation without intubation and tracheal suctioning
15845886|NCT04076176|Dietary Supplement|CGMP protein substitute|PKU sphere is a powdered, low phenylalanine protein substitute, containing a balanced mix of casein glycomacropeptide (CGMP) isolate, essential and non-essential amino acids, carbohydrate, vitamins, minerals, trace elements and the omega-3 long chain polyunsaturated fatty acid (LCP); docosahexaenoic acid.
15845887|NCT04076176|Dietary Supplement|L-amino acid protein substitute|Patient may choose from a list of products, specified in the protocol, that are nutritionally comparable to PKU Sphere.
15845888|NCT04076163|Other|serious game|a serious game was performed by the investigators in order to enhance the critical appraisal practice of students
15845889|NCT04076150|Device|Transcatheter Aortic Valve (TAV) Implantation With The Optimum TAV System|Treating patients with severe symptomatic aortic stenosis via transcatheter aortic valve implantation by implanting the Optimum TAV inside the native diseased valve via a the Precision Catheter. The Optimum TAV and Precision Catheter together are the Optimum TAV System.
15845890|NCT04076137|Other|Targeted T-cell armed with bispecific antibody (Decitabine)|In this study, 10 patients eligible for the study were clinically screened for intravenous infusion of targeted activated T cells,every participant has a unique identification number and emergency letter which have the information of group.
15845891|NCT04076124|Device|Active rTMS-DLPFC|Participants in the rTMS active stimulation group will receive 4-week 10 Hz 120% of RMT to left DLPFC. Left side DLPFC will be targeted by MRI-neuronavigation system. Stimulation will be delivered to the L-DLPFC using a Magstim stimulator.
15845892|NCT04076124|Device|Active iTBS-DLPFC|Participants in the intermittent TBS(iTBS) active stimulation group will receive 4-week three-pulse 50-Hz bursts administered every 200 milliseconds (at 5 Hz) at an intensity of 80% active motor threshold (MT) to left DLPFC. Left side DLPFC will be targeted by MRI-neuronavigation system. Stimulation will be delivered to the L-DLPFC using a Magstim stimulator.
15845893|NCT04076124|Device|Sham TBS-DLPFC or Sham rTMS-DLPFC|Half of the patients in the sham group received 4-week the same iTBS parameter stimulation (sham-iTBS), and the other half received the same rTMS parameter stimulation using a sham coil (sham-rTMS), which also improved the blinding process.
15845894|NCT04076098|Drug|Minocycline Hydrochloride|Administration of Periocline gel into the periodontal pockets will be carried out until it overflows the pockets
15845895|NCT04076085|Other|exercise|Stretching exercise for warmup, All arm exercise with and without weights as tolerated by the patients. Similarly lower limb exercise in different positions like lying standing as tolerated by the patients
15845896|NCT04076072|Device|Utravit High-Speed 10000 cpm Beveled Probe|This is a prospective, randomized controlled trial comparing the Ultravit High-Speed Beveled Probe with the current Alcon vitrector probe in a cohort of patients undergoing routine vitrectomy surgery.
15845897|NCT04076072|Device|standard vitrector probe- Alcon (non-beveled) Ultravit 7500 cpm|This is a prospective, randomized controlled trial comparing the Ultravit High-Speed Beveled Probe with the current Alcon vitrector probe in a cohort of patients undergoing routine vitrectomy surgery.
15845898|NCT04076059|Drug|Enzalutamide|Oral
15845899|NCT04076059|Drug|Placebo|Oral
15845900|NCT04076059|Drug|Androgen deprivation therapy (ADT)|All participants will be required to maintain ADT during study treatment, either using luteinizing hormone-releasing hormone (LHRH) agonist/antagonist or having a history of bilateral orchiectomy.
15845901|NCT04076033|Other|functional compressive bandage|"The functional compressive bandage is being performed with the volunteer sitting with the upper limb homolateral to the surgery supported by a support. After hydration of the limb, a cotton mesh is being used to prevent friction of the 1 cm density foam band being wrapped around the limb. No therapeutic procedure is being performed prior to functional compressive bandage.
~The bandage of the limb is being performed with 5 cm, 10 cm, 15 cm elastic cotton bandages from the fingers to the axillary region in four layers."
15845902|NCT04076020|Behavioral|Relational agent/AliveCor Kardia - Intervention Group|Use of the relational agent and Kardia daily for 120 days.
15845903|NCT04076020|Behavioral|Usual Care|Use of the WebMD app daily for 120 days.
15845904|NCT04076007|Dietary Supplement|Beetroot juice|
15845905|NCT04076007|Dietary Supplement|Nitrate depleted beetroot juice|
15845906|NCT04075994|Behavioral|Relational Agent and heart rate and rhythm monitor|Use of the Relational Agent and heart rate and rhythm monitor daily for 120 days.
15845907|NCT04075994|Behavioral|Usual Care|Use of the WebMD app and heart rate and rhythm monitor daily for 120 days.
15845908|NCT04075981|Drug|Botulinum Toxin Type A Injection [Xeomin]|Before the main stage of the surgery, botulinum toxin will be injected into the entire visible area of the 4 major epicardial fat pads, during extra corporal circulation and before aortic cross clamping in order to reduce the time of ischemia.
15845909|NCT04075981|Other|Drug placebo|All patients from the control group will receive placebo. Before the main stage of the surgery, during extra corporal circulation and before aortic cross clamping, the placebo will be injected into the entire visible area of the 4 major epicardial fat pads as follows (1 mL at each fat pad).
15845910|NCT04075968|Other|Cognitive exercise|Cognitive exercise will be applied
15845911|NCT04075968|Other|Home exercise|Home exercise will be applied
15845912|NCT04075955|Drug|Zyprexa® (OLANZapine 5MG)|"Olanzapine 5mg orally at bedtime for 4 days (starting the day before the chemotherapy)
~Ondansetron 16mg orally pre-chemotherapy on day 1
~Dexamethasone 12mg orally pre-chemotherapy on day 1
~Dexamethasone 8mg orally twice a day for 6 doses (starting on the morning of day 2)"
15845913|NCT04075955|Drug|Emend® (Aprepitant)|"Aprepitant 125mg orally pre-chemotherapy on day 1, then 80mg orally once daily on days 2 and 3
~Ondansetron 16mg orally pre-chemotherapy on day 1
~Dexamethasone 12mg orally pre-chemotherapy on day 1
~Dexamethasone 8mg orally once daily for 3 doses (starting on the morning of day 2)"
15845914|NCT04075942|Procedure|Atrophic Anterior Maxillary Ridges|Use of modified cortical shell technique grafted with customized Xenograft bone shell
15845915|NCT04075929|Other|Training effects on aerobic output|The cyclists were allowed to perform ad libitum low intensity (LIT) in addition to high intensity (HIT) sessions that were determined to each group. The cyclists completed 12 supervised HIT sessions during the intervention period, three HIT sessions per week with at least 48 hours between each HIT-session. All HIT sessions were performed as supervised group training sessions. Each HIT session started with an individual 30 minutes' warm up at low intensity (55-70% HRmax) interspersed by freely chosen progressive sprints. For all groups the power output during the recovery periods was 50 % of the power output used during work intervals. The cyclists in all groups were instructed to perform each interval session at their maximal sustainable intensity. Each session ended with 15-20 minutes' cool down (55-70% HRmax). All HIT sessions were supervised and performed in groups on the University of Agder's (UiA) premises at Spicheren fitness center in Kristiansand.
15845916|NCT04075916|Drug|Epclusa|All patients will receive 12 weeks of sofosbuvir/velpatasvir as per the FDA label.
15845917|NCT04075903|Behavioral|Storytelling|"A health literacy-appropriate and culturally-adapted intervention delivered on a tablet computer containing storytelling to improve patient gout knowledge and approaches to prevent flares, destigmatize gout, and enhance readiness to adopt available long-term treatments for gout including medications, diet, and exercise, or ii) usual gout care (control state)."
15845918|NCT04075890|Device|transcranial Direct Current Stimulation (tDCS)|tDCS is a non-invasive brain stimulation method by which constant low direct current can be delivered to the sculpt for changing the excitability of neuronal structure adjunct to the stimulating electrode.
15845919|NCT04075877|Behavioral|FOCUS|See prior section.
15845921|NCT04075838|Other|Recovery group|The researchers designed a recovery group suited to Taiwanese with mental illness, according to content of the PTR (Ridgway et al., 2002) and recovery-related literature (Davidson et al., 2005; Ridgway, 2001)
15845922|NCT04075825|Biological|Darvadstrocel|Allogenic eASCs 5 million cells/ml - suspension for injection Cx601 received in previous ADMIRE-CD II study. No drug administration in this study.
15845923|NCT04075812|Device|Neuromuscular Stimulator|
15845924|NCT04075799|Other|high-intensity interval training|The HIIT protocol consists of 8 weeks using stair climbing three times per week. The warm-up will consist of 2 minutes of ascending and descending the stairs at a comfortable pace. The high-intensity intermittent exercise will comprise 6-12 x 30-seconds bouts of ascending at an all-effort. A 30- seconds walking recovery will occur between the exercise bouts. Post-exercise the subject will walk during a 2-minute cool down. Every session will last between 10 to 15 minutes. The number of bouts (6-12) will be increased progressively over the weeks. The first (week 1) and final week (week 8) of the exercise program will be monitored by a trained exercise physiologist. During supervised visits, heart rate and rating of perceived exertion (OMNI scale) will be measured at the end of each bout and after active recovery. Subjects will have the option to request further monitoring if desired.
15845925|NCT04075786|Other|Survey|Each participant will be shown 40 (forty) 3D ultrasound images of uterus of normal women without infertility and 40 (forty) infertile women with uterus with narrowing in the middle third diagnosed by hysteroscopy + 3D ultrasound and associated infertility (T, Y or I shaped).
15845926|NCT04075773|Behavioral|Expressive Writing|The participants are asked to write for a period of time about specific concepts so that they think carefully and cognitively process the information they are generating.
15845984|NCT04075305|Radiation|Radiation therapy|Radiation therapy on the CE marked and FDA approved MR-Linac
15845927|NCT04075760|Procedure|Coils + Cyanoacrylate Group + beta-blocker|"EUS-combined coiling and cyanoacrylate injection into the feeder vessel of GOV II and IGV I
~Patients with Gastric Varices GOV II or IGV I that have never bleed and are of high-risk GV according to Baveno VI consensus will be prophylactically obliterated via the EUS-guided coiling and cyanoacrylate injection. Patients will also be on beta-blocker therapy as indicated in the other group."
15845928|NCT04075760|Drug|beta blocker therapy|A beta-blocker (propranolol) was started at a dose of 20 mg twice daily. The principle of incremental dosing was used to achieve the target heart rate for propranolol. The dose was increased every alternate day to achieve a target heart rate of 55/min or to the maximal dose to 360 mg/day if the medication was well tolerated and the systolic blood pressure was > 90 mm Hg. On the occurrence of intolerable adverse effects, systolic blood pressure < 90 mm Hg or pulse rate < 55/min, the dose of the medication was decreased step-wise, and eventually stopped if these adverse events persisted. Reintroduction of the medication was attempted if cessation of the medication did not result in improvement of the reported side-effect.
15845929|NCT04075747|Drug|CPX-351|Up to 2 induction and 2 consolidation courses will be offered
15845930|NCT04075747|Drug|Venetoclax|Will be administered over specified duration during induction and consolidation courses
15845931|NCT04075747|Drug|Midostaurin|Will be administered over specified duration during induction and consolidation courses
15845932|NCT04075747|Drug|Enasidenib|Will be administered over specified duration during induction and consolidation courses
15845933|NCT04075734|Behavioral|Managing Your Health: Self-Management + Peer Mentoring|"The online educational component consists of 5 self-management educational modules:
~(1) Understanding Your Survivorship Care Plan; (2) Managing Your Healthcare; (3) Family and Significant Other Involvement in Your Healthcare; (4) Emotions about Your Health and Follow-Up Care; (5) Staying Healthy.
~Participants will be matched with a peer mentor and complete a total of six calls. The first call is to build a rapport and identify the participant's self-management strengths, weaknesses, and goals. The next five calls align with the topic of each module, which the mentee is expected to complete prior to their scheduled call."
15845934|NCT04075721|Drug|M3258|Participants will receive M3258 in a protocol-defined dose escalation scheme in Part A and M3258 at a dose and regimen defined and considered to be safe by safety monitoring committee (SMC) in Part B until disease progression.
15845935|NCT04075721|Drug|Dexamethasone|Participants will receive dexamethasone at a cumulative dose of 40 milligrams per week along with M3258 in Part B until disease progression.
15845936|NCT04075682|Other|Inserts with efficacy messages|Four rotating inserts (i.e., small, printed messages) with messages about cessation benefits (i.e., response efficacy) and tips to quit (i.e., self-efficacy messages) will be placed inside cigarette packs.
15845937|NCT04075682|Other|Pictorial warnings on packs|Four rotating pictorial warnings illustrating the harms of smoking will be printed on labels that will placed on and cover approximately 50% of the cigarette packs.
15845938|NCT04075669|Diagnostic Test|Multiplex Strip PCR|Corneal scraping from patients will have its DNA extracted and eluted in the buffer. The DNA than mixed with the primer strips tube and be analyzed in Real-Time PCR machine. According to the record information from the hospital, the pathogen that usually found from endophthalmitis, keratitis, corneal ulcer diseases in our hospital is Pseudomonas sp., Staphylococcus aureus, Staphylococcus epidermidis, Acinetobacter sp., Pseudomonas aeruginosa, Acanthamoeba sp., Aspergillus fumigatus, Aspergillus flavus, Fusarium sp., and Candida albicans. And based on the report from Zhao et al (2014) Herpes Simplex Virus may be detected from patients with keratitis. Therefore in this study, we are trying to detect all of the pathogens simultaneously using the real-time PCR assay from patients corneal scraping who experience eye infections as mention above.
15845939|NCT04075656|Behavioral|Standard of Care|Participants will be provided a folder of educational material on NS, including general information on symptoms, treatments, and possible complications; healthy diet for children taking corticosteroids; and low sodium diet. Site research staff will demonstrate how to check urine for protein with test strips, and educate patients on the definitions of disease relapse and remission. Urine test strips and urine protein logs will be provided to ensure that each participant can check their urine daily for protein. Participants will be instructed to check their urine daily for protein and call their provider within 1 business day for relapses and remissions.
15845940|NCT04075656|Behavioral|UrApp|Caregivers/parents will download UrApp at the baseline visit. UrApp contains instructional videos to guide users. The telephone number of the patient's provider will be entered into UrApp and participants will be able to call their providers directly through UrApp. The email address of the Emory study staff will also be entered. UrApp will automatically e-mail test results to the research staff when elected by the users. Participants will be asked by study staff, and reminded by the app, to call their providers and send urine testing results to the study staff whenever there is a relapse or remission. When the study staff receives alerts of a relapse/remission via UrApp, the information will be communicated to the treating physician within 1 business day.
15845941|NCT04075643|Drug|Reference drug|D935 Cap. 1 Cap., single oral administration under fasting condition
15845942|NCT04075643|Drug|Test drug|CKD-385 Tab. 1 Tab., single oral administration under fasting condition
15845943|NCT04075617|Device|electronic habit reminder|Habit reminder in the form of wrist watch with music that display as reminder is one of recent innovations for cessation of the habit in short time and the child accepts it and it's comfortable
15845944|NCT04075617|Other|palatal crib|Fixed palatal crib is commonly used and recommended for treating thumb/finger sucking habit.
15845945|NCT04075604|Biological|Nivolumab|Specified Dose on Specified Days
15845946|NCT04075604|Drug|Anastrozole|Specified Dose on Specified Days
15845947|NCT04075604|Drug|Palbociclib|Specified Dose on Specified Days
15845948|NCT04075591|Device|iDesign Refractive Studio with STAR S4 IR® Excimer laser System|Surgeons will perform wavefront-guided monovision LASIK for the treatment of myopic subjects with presbyopia based upon measurements obtained with an iDesign Refractive Studio.
15845949|NCT04075578|Drug|OnabotulinumtoxinA / Botox®, Allergan Ltd, Irvine, CA, United-States|Botox® intradetrusor injections, with a rigid cystoscope, under local anaesthesia performed by Lidocaïne 2% diluted in 30ml of bicarbonate 14‰. 20 injections of 0,5ml each will be heterogeneously administrated into the bladder wall, sparing the trigone
15845985|NCT04075292|Drug|Acalabrutinib|acalabrutinib 100 mg twice daily orally
15846351|NCT04072354|Drug|SEP-363856 75mg|SEP-363856 75mg tablet dosed once daily
15845950|NCT04075565|Behavioral|Terrestrial altitude|Terrestrial altitude: The volunteers are in an SAC hut at an altitude of 3000 m. By means of this exposure the psychophysiological effect under hypobaric and hypoxic conditions is determined. The subjects spend the night in this SAC hut and the measurements are repeated the next day.
15845951|NCT04075565|Behavioral|Cloud 9|"Cloud 9 is a solid, certified product that complies with European Directives on Electromagnetic Compatibility, Machine Directive, Air Pressure Equipment and Low Voltage Equipment (89/336 / EEC, 91/368 / CEE, 93/68 / CEE, 97/23 / EC, EN61010-1 All directives are in writing in the Supplements to this Ethics Application.
~Simulated height: The subjects are in the laboratory of our institution and are connected to the Cloud 9 by means of a mask. Subjects are exposed to a simulated altitude of 3530m under normobaric conditions. By means of this intervention the psychophysiological effect under normobaric and hypoxic conditions is determined."
15845952|NCT04075552|Behavioral|Pre Meal Presentation|Pre-Meal Presentation. In the Pre-Meal Presentation (PMP) condition, school staff delivered the plate of vegetable pieces prior to students regularly scheduled lunchtime (about 5 min). Like baseline, no programmed consequences were provided for student interaction or consumption of the vegetables.
15845953|NCT04075552|Behavioral|Pre Meal Presentation + Modeling|"Similar to the prior condition, each participant will be offered a plate containing target foods for 4 min. Once the plate has been delivered to each participant, a staff person will model eating the food. The model will have an identical plate of food. Within six feet of students oriented towards the model (i.e., the students will be facing the model), the model will pick up one piece of food, say Yum, this looks good in a loud and excited tone, eat it, and then deliver a soft prompt to the participants to try it (e.g., You should try this!). Staff will avoid giving a firm/hard demand (e.g., Eat the food). Repeat this for four pieces of food, alternating between the two target foods, with about 10-20 sec between each bite. Repeat the model as necessary based on the room arrangement, such that each students contacts the model within six feet while oriented towards the model."
15845954|NCT04075552|Behavioral|Pre Meal Presentation + Token Economy|Similar to prior condition, expect each participant can earn tokens for eating food items. Tokens can be exchanged for small prizes (e.g., pencil or sticker) at the end of a session.
15845955|NCT04075539|Other|Home-based cycling program|"Usual care (i.e. standardized prescription of 6 sessions of outpatient physiotherapy), and
~1 supervised session of cycling aimed at explaining how to use the connected ergometric bicycle and at designing a personalized home-based cycling program
~a 12-month home-based cycling program using connected ergometric bicycles which intensity and dose are self-determined
~3 phone or email contacts with a care provider to deliver positive feedbacks and encouragements"
15845956|NCT04075539|Other|usual care|A prescription of 6 sessions of outpatient physiotherapy
15845957|NCT04075526|Drug|Povidone iodine|To create the dilute solution, a staff member will draw up 17.5 mL of 10% povidone iodine with a syringe and mix it with 500 mL of normal saline, resulting in a dilution of 0.35% povidone iodine solution for use before wound closure.
15845958|NCT04075526|Drug|Vancomycin powder|2 grams of vancomycin powder will be applied to the wound and will be distributed so that approximately 1 gram is administered deep to the fascia and 1 gram superficial to the fascia
15845959|NCT04075526|Other|Conventional|No additional steps in management are required for the control arm of the study besides lavage with 1 L of isotonic sodium chloride solution without antibiotics. No vancomycin powder or dilute povidone iodine lavage would be utilized in this cohort
15845960|NCT04075513|Drug|Insulin glargine, 300 U/ml|"Pharmaceutical form:solution for injection in a prefilled pen
~Route of administration: subcutaneous injection"
15845961|NCT04075513|Drug|Insulin degludec, 100U/ml|"Pharmaceutical form:solution for injection in a prefilled pen
~Route of administration: subcutaneous injection"
15845962|NCT04075513|Drug|Background therapy: Rapid acting insulin analogs|Route of administration: subcutaneous injection
15845963|NCT04075500|Device|24-h Holter monitoring|Patients will be randomized to either receive 24-h Holter monitoring or receive one of the two modes for prolonged ECG recording (interventional arms). There are two interventional arms. Patients will either undergo 28-day ECG recording using a commercially available Holter recorder that can function as a non-invasive ECG patch or receive an implantable cardiac device (REVEAL LINQ).
15845965|NCT04075474|Device|silver diamine fluoride|38% SDF on primary upper anterior teeth
15845966|NCT04075474|Device|sodium fluoride|5% NaF on primary upper anterior teeth
15845967|NCT04075461|Procedure|Arthroplasty|Arthroplasty is commonly used for a displaced femoral neck fracture.
15845968|NCT04075461|Procedure|Internal fixation|Internal fixation is commonly used for undisplaced femoral neck fracture
15845969|NCT04075448|Other|Control|100 grams breakfast cereal
15845970|NCT04075448|Other|50 g Walnut|50 grams walnuts mixed with 50 gram breakfast cereal.
15845971|NCT04075435|Drug|high CBD/low THC sublingual solution|Hemp derived solution to be administered sublingually twice daily.
15845972|NCT04075422|Drug|Bezlotoxumab Injection [Zinplava]|Treatment with bezlotoxumad according to the routine clinical practices
15845973|NCT04075409|Drug|Padsevonil|Padsevonil will be administered in predefined dosages.
15845974|NCT04075396|Drug|Lazertinib|Participants will receive Lazertinib tablets once daily.
15845975|NCT04075383|Procedure|immediate dental implant|Replacement of a lost tooth with a titanium screw retained in the alveolar bone in the same session of tooth extraction.
15845976|NCT04075383|Procedure|immediate-delayed dental implant|Replacement of a lost tooth with a titanium screw retained in the alveolar bone 8 weeks after tooth extraction.
15845977|NCT04075370|Other|Neuropsychological Testing|Measure cognition function and cognitive reserve in patients before, during and after radiation therapy using cumulative scores of Hollingshead Index, North American Adult Reading Test, HVLT-R, TMT A&B and COWA over time.
15845978|NCT04075357|Other|Amniotic membrane transplantation|Amniotic membrane was located over median nerve during surgery of CTS, prior of closing.
15845979|NCT04075344|Other|Multimodal Infection control programme|12 weekse educational programme with 6 sessions, 45 minutes per session will be provided to experimental group RCHEs staff
15845980|NCT04075331|Drug|Mepolizumab|Mepolizumab 100mg subcutaneous injection
15845981|NCT04075331|Drug|Placebo|Saline solution for subcutaneous injection
15845989|NCT04075253|Behavioral|VO2 peak testing|Exercise on treadmill starts with ~4km/h at 0% inclination before inclination is increased to 4% and speed kept unchanged. Inclination will then be increased with two percent approximately after each minute until exhaustion.
15845990|NCT04075240|Drug|Rivaroxaban 10 MG and acetylsalicylic acid 81 mg|Starting post op, rivaroxaban (5 days) followed by aspirin (9 days for TKA; 30 days for THA)
15845991|NCT04075240|Drug|acetylsalicylic acid 81 mg|Starting post op, aspirin for 9 days for TKA and 30 days for THA
15845992|NCT04075227|Drug|0.2% loteprednol etabonate|Use topical 0.2% loteprednol etabonate eyedrop every 4-6 hours for 4 weeks. After that, the regimen was gradually decreased until cessation at 3 months.
15845993|NCT04075227|Drug|0.1% dexamethasone|Use topical 0.1% dexamethasone eyedrop every 4-6 hours for 4 weeks. After that, the regimen was gradually decreased until cessation at 3 months.
15845994|NCT04075214|Device|transcutaneous auricular neurostimulation (tAN)|Phoenix tAN system
15845995|NCT04075201|Biological|One dose of investigational vaccine|One dose of investigational hepatitis B vaccine (10μg/0.5ml) developed by Sinovac Research & Development Co., Ltd.
15845996|NCT04075201|Biological|One dose of control vaccine|One dose of control hepatitis B vaccine (10μg/0.5ml) manufactured by Dalian Hissen Bio-pharmInc.
15845997|NCT04075201|Biological|Three doses of investigational vaccine|Three doses of investigational hepatitis B vaccine (10μg/0.5ml) developed by Sinovac Research & Development Co., Ltd. on the schedule of month 0,1,2
15845998|NCT04075201|Biological|Three doses of control vaccine|Three doses of control hepatitis B vaccine (10μg/0.5ml) manufactured by Dalian Hissen Bio-pharmInc.
15845999|NCT04075188|Drug|Aflibercept Injection|Patients will be treated with combined therapy to determine the synergy of this treatment, causing anti- Vascular Endothelial Growth Factor (anti-VEGF) to block neovascular exudation and photodynamic therapy to close aneurismal vessel and reduce choroidal vascular congestion.
15846000|NCT04075175|Drug|S315|Human monoclonal antibody against Diphtheria Toxin
15846001|NCT04075175|Drug|0.9% Sodium Chloride (NaCl)|Placebo 0.9% Sodium Chloride (NaCl)
15846002|NCT04075149|Drug|Spironolactone|Spironolactone is an androgen-receptor commonly used (off-label) for hyperandrogenism in girls and women. It is used in this study to determine if androgen blockade can improve ovulation rates in girls with androgen excess, who often have low rates of ovulation in the years following menarche. The spironolactone dose will be as follows: If ≤ 60 kg, 50 mg twice daily; if > 60 kg, 100 mg twice daily.
15846003|NCT04075136|Drug|Ranibizumab|Intravitreal injection 0.5 MG Per 0.05 ML Injection.
15846004|NCT04075136|Device|Photodynamic laser treatment (PDT)|PDT light dose of 50 J/cm2 of neovascular lesion administered at an intensity of 600mW/cm2. A Visudyne infusion will be administered for the PDT portion of the treatment at a dose of 6mg/m2 body surface area. PDT will be administered at half-fluence - measured by time, i.e. 42 seconds as opposed to full-fluence which is 83 seconds.
15846005|NCT04075136|Drug|Triamcinolone Acetonide|Intravitreal injection of 0.5ml-2mg
15846006|NCT04075136|Drug|verteporfin|Visudyne infusion will be administered for the PDT portion of the treatment at a dose of 6mg/m2 body surface area.
15846007|NCT04075123|Other|CPAP|The two NRS strategies being compared will be initiated at the time of first extubation (NRS support practices prior to initial intubation will be as per local unit guidelines and practices) and all subsequent extubations (if applicable) until 32 weeks PMA. For instance, a unit adopting post-extubation NCPAP strategy will initiate this mode following the initial and all subsequent extubations until 32 weeks PMA whereas centres adopting post-extubation NIPPV will initiate NIPPV following initial and all subsequent extubations until 32 weeks PMA.
15846009|NCT04075097|Behavioral|Aerobic exercise|1 session
15846010|NCT04075097|Behavioral|Iyengar yoga|1 session
15846011|NCT04075071|Behavioral|Teacher-Child Interaction Training - Universal|Teacher-Child Interaction Training - Universal (TCIT-U) is an empirically-supported classroom-based intervention designed to strengthen teacher-child relationships, reduce and prevent child behavior problems, and promote social-emotional skills. TCIT-U is based in behavioral and attachment principles and was developed as a modification of Parent-Child Interaction Therapy (PCIT), an evidence-based treatment with well-established support for decreasing disruptive child behaviors and parental stress with children ages two to seven years old. In TCIT-U, teachers of children, preschool through second grade, are taught and coached in skills to manage challenging classroom behaviors and improve the quality of relationships. TCIT-U is delivered to teachers through group didactic training and live individualized coaching.
15846012|NCT04075058|Radiation|Hypofractionated Radiation therapy|
15846013|NCT04075045|Behavioral|Wellth Smartphone App|Patients will receive the app that provides reminders to adhere to their self-care regimen and ability to track their daily adherence via photos of the self-care related items (medications, blood pressure cuff, meals).
15846014|NCT04075045|Behavioral|Targeted Incentives|Participants may earn up financial rewards tied to their adherence. The rewards are only usable at pharmacies.
15846015|NCT04075045|Behavioral|Non-Restricted Incentives|Participants may earn up financial rewards tied to their adherence. The rewards are only usable at most stores, except for prohibited purchases such as alcohol, tobacco, or firearms, and is not redeemable for cash.
15846016|NCT04075032|Dietary Supplement|Pomegranate extract|Pomegranate extract consumption (900 mg/day) for 4 weeks
15846017|NCT04075032|Other|Placebo|Placebo (microcrystalline cellulose) consumption (900 mg/day) for 4 weeks
15846018|NCT04075019|Behavioral|The Raising Healthy Children intervention, including teacher training, child skill development, and parent training|
15846019|NCT04075006|Drug|Ketamine|standard of care plus Ketamine infusion at a fixed rate of 0.12 mg/kg/hr (2 µg/kg/min) in the first 24 hours followed by 0.06 mg/kg/hr (1 µg/kg/min) in the second 24 hours, then discontinued
15846020|NCT04074993|Drug|Brigatinib|Subject will be treated with Brigatinib 90mg/day for 1 week and then 180mg/day PO daily. A Cycle will be defined as 28-days. Treatment will be continued until disease progression or unacceptable toxicity.
15846021|NCT04074980|Diagnostic Test|Venous and Fingerstick blood draws|Fingerstick sampling to collect blood from subjects Venepuncture to collect blood samples from subjects
15846022|NCT04074980|Diagnostic Test|Venous blood draw|Venepuncture to collect blood samples from subjects
15846023|NCT04074967|Drug|Phase Ib ARRY-614 + nivolumab|ARRY-614 continuously in 4-week cycles (± 3 days). Nivolumab will be dosed according to FDA-approved dosing schedule.
15846024|NCT04074967|Drug|Phase Ib ARRY-614 + nivolumab+ipilimumab|ARRY-614 continuously in 4-week cycles (± 3 days). Nivolumab will be dosed according to FDA-approved dosing schedule. Ipilimumab therapy will be dosed according to FDA-approved dosing schedule.
15846025|NCT04074967|Drug|Phase II ARRY-614 + nivolumab|"Recommended Phase II dose of ARRY-614 (to be determined) daily in 4-week cycles (± 3 days).
~Nivolumab will be dosed according to FDA-approved dosing schedule."
15846026|NCT04074967|Drug|Phase II ARRY-614 + nivolumab+ipilimumab (melanoma)|"Recommended Phase II dose of ARRY-614 (to be determined) daily in 4-week cycles (± 3 days).
~Nivolumab will be dosed according to FDA-approved dosing schedule. Ipilimumab therapy will be dosed according to FDA-approved dosing schedule."
15846027|NCT04074967|Drug|Phase II ARRY-614 + nivolumab+ipilimumab (RCC)|"Recommended Phase II dose of ARRY-614 (to be determined) daily in 4-week cycles (± 3 days).
~Nivolumab will be dosed according to FDA-approved dosing schedule. Ipilimumab therapy will be dosed according to FDA-approved dosing schedule."
15846028|NCT04074954|Procedure|Cataract surgery|Patients will receive cataract surgery
15846029|NCT04074941|Other|Dietary intervention|Intervention include low sodium or usual sodium diet
15846030|NCT04074928|Biological|QIVc|Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains.
15846031|NCT04074928|Biological|Comparator QIV|Comparator Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains.
15846032|NCT04074915|Other|Placebo mouth rinse|Normal saline
15846033|NCT04074915|Drug|Chlorhexidine mouth rinse|Chlorhexidine gluconate
15846034|NCT04074915|Drug|Test group|Chamomile mouth rinse
15846035|NCT04074902|Device|Ultrasonography|Mindray dp1100 plus.
15846036|NCT04074889|Dietary Supplement|(Microbial cell preparation) Probiotics|Lactobacillus acidophilus (107mg), Lactobacillus casei subsp (107mg), Lactobacillus lactis (107mg), Bifidobacterium bifidum (107mg), Bifidobacterium infantis (107mg) and Bifidobacterium longum (107mg)
15846037|NCT04074889|Other|Placebo|Placebo sachet with no microbial cell preparation
15846038|NCT04074876|Device|Pulmonary echography|"Pulmonary echography during preoperative evaluation for patients undergoing urgency orthopedic surgery for femur fracture.
~Pulmonary ultrasound will evaluate the presence of one of four patterns defined by Lung Ultrasound Score in the 6 fields for each hemithorax of the patient (2 anterior, 2 lateral and 2 posterior). Each region is defined by axillary lines (anterior and posterior) and then is divided into 2 subregions (superior and inferior), thus defining the 6 fields. For a comprehensive exam, all intercostal spaces in the setting of each field will have to be examined by sliding the probe along them . A score will be used for each field that will have this definition:
~0: normal pattern (A-lines)
~1: multiple B lines (at least 3 for field), well defined.
~2: B lines coalescent
~3: consolidation of any dimension"
15846039|NCT04074863|Procedure|Darrach|Surgical treatment of painful DRU osteoarthritis with resection of distal ulna
15846040|NCT04074863|Procedure|Prosthesis|Surgical treatment of painful DRU osteoarthritis with distal ulna replacement with Herbert implant
15846041|NCT04074837|Drug|NNI-362|NNI-362 small molecule in liquid suspension.
15846042|NCT04074837|Drug|Placebo|Placebo liquid suspension
15846043|NCT04074811|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|The investigators will use the Figure of 8 coil, which affects ~10cm2 of cortical surface. The active condition will deliver stimulation at 110% of resting motor threshold (RMT). To determine RMT, the protocol will be: 10 trials of single-pulse TMS on the scalp position of the abductor pollicis brevis muscle (which controls thumb flexion); RMT is the lowest TMS power setting yielding visible motor contraction on >50% of trials.
15846044|NCT04074798|Behavioral|assessment of hyperventilation, postural control and psychological behavior|assessment of hyperventilation, postural control and psychological behavior
15846045|NCT04074785|Drug|Abemaciclib|Abemaciclib 150 mg po bid
15846046|NCT04074785|Drug|Bevacizumab|Bevacizumab 10 mg/kg IV every 2 weeks, then continue treatments for 2 cycles
15846047|NCT04074759|Biological|FPT155|A soluble CD80 fusion protein
15846048|NCT04074759|Biological|pembrolizumab|An anti-PD1 antibody
15846049|NCT04074746|Biological|Anti-CD30/CD16A Monoclonal Antibody AFM13|Given IV
15846050|NCT04074746|Drug|Cyclophosphamide|Given IV
15846051|NCT04074746|Drug|Fludarabine|Given IV
15846052|NCT04074746|Drug|Fludarabine Phosphate|Given IV
15846053|NCT04074746|Biological|Genetically Engineered Lymphocyte Therapy|Given AFM13-NK cells IV
15846054|NCT04074733|Diagnostic Test|Patient undergoes a ULD scan|"The following doses will be applied:
~6 mGy.cm for the extremities 50 mGy.cm for the dorsal spine 130 mGy.cm for the lumbar spine 130 mGy.cm for the pelvis"
15846055|NCT04074733|Diagnostic Test|Patient undergoes a standard X-ray|"The following doses will be applied:
~For the pelvis : front view and profile for the hip. For the dorsal spine : front and profile. For the lumbar spine : front and profile For the extremities : front and profile"
15846056|NCT04074733|Diagnostic Test|Patient undergoes a classic-dose scan|"The following doses will be applied:
~6 mGy.cm for the extremities 50 mGy.cm for the dorsal spine 130 mGy.cm for the lumbar spine 130 mGy.cm for the pelvis"
15846057|NCT04074720|Procedure|Tissue Sample collection|Tissue sample collected following standard of care procedure patient was already scheduled to have
15846058|NCT04074720|Other|Blood Sample Collection|A one time sample of blood will be collected on day of standard of care procedure
15846059|NCT04074720|Other|Rectal Swab|optional rectal swab may be collected on day of standard of care procedure
15846100|NCT04074382|Other|Online Questionnaires|We will use online questionnaires to complete research into functional outcomes after trauma
15846352|NCT04072354|Drug|Placebo|Placebo tablet dosed once daily
15846060|NCT04074707|Dietary Supplement|Labeled iron solution (60mg and 120mg Ferrous Sulfate)|3 doses of 60mg iron as FeSO4 are given on 3 consecutive days (e.g., days 1-3); 3 doses of 120mg iron as FeSO4 are given on one consecutive and one alternate day (e.g., days 20, 21, 23); 3 doses of 120mg iron as FeSO4 are given on one consecutive and one 3rd day (e.g., days 37, 38, 41). Iron doses are labeled with 4mg of a stable isotope in 100ml deionized water (57Fe, 58Fe or 54Fe). Participants will be randomly assigned to start with daily, alternate-day or every-third day dosing.
15846061|NCT04074694|Procedure|Sialoendoscopy|Sialoendoscopy
15846062|NCT04074681|Behavioral|Gambling Internet-based Protocol|Gambling Internet-based protocol is a multimedia interactive and self-help program for problem and pathological gamblers, which will allow individuals to learn and practice adaptive ways to cope with this problem. The main therapeutic modules included in this program are: 1) Motivational for change; 2) Psychoeducation; 3) Stimulus control (e.g. self-prohibition and blocking of usual gambling websites with therapist confirmation) and responsible return of debts; 4) Cognitive restructuring; 5) Emotion regulation; 6) Planning of significant activities; 7) Coping skills and exposure with response prevention; 8) Relapse prevention.
15846063|NCT04074668|Drug|Aminohippurate Sodium Inj 20%|Diagnostic aid/agent used to measure effective renal plasma flow (ERPF)
15846064|NCT04074668|Drug|Iohexol Inj 300 milligrams/milliliter (mg/ml)|Diagnostic aid/agent used to measure glomerular filtration rate (GFR)
15846065|NCT04074668|Radiation|PET/CT Scan|Imaging used to visualize the kidneys and quantify renal metabolic activity
15846066|NCT04074668|Procedure|Renal Biopsy|Minimally invasive outpatient procedure to obtain renal tissue after ultrasound visualization.
15846067|NCT04074655|Device|Driving Simulator in a Virtual Reality Environment|Driving simulator in virtual reality environment is a game with the several level of difficulty and the goal of improving the cognition level of participants in general and their spatial cognition in particular. Moreover this game, will have a positive effect on its users' mood as well.
15846068|NCT04074642|Procedure|Neurosurgery|adenoma removal
15846069|NCT04074629|Diagnostic Test|Diagnosis, skin volatile organic compounds (VOCs)|"The skin related VOCs will be collected by off-line method using Polydimethylsiloxane (PDMS) patches from different body locations for sensor system and\or GC-MS analysis"
15846072|NCT04074603|Device|The needle-free jet injector|Continuous insulin therapy for 2 weeks
15846073|NCT04074603|Device|Conventional insulin pen|Continuous insulin therapy for 2 weeks
15846076|NCT04074577|Diagnostic Test|Standard technique First|colonoscopy without automated polyp detection software
15846077|NCT04074577|Diagnostic Test|combination technique First|automated polyp detection software
15846078|NCT04074564|Combination Product|MASCT-I,PD1 Antibody,Apatinib|"Multi-antigen autoimmune cell injection (MASCT-I) is an adoptive cellular immunotherapeutic product being developed by Heng Ruiyuan.
~PD1 antibody is a blocking antibody of human programmed death receptor-1 (PD-1). It can bind to PD-1 receptor, block its interaction with PD-L 1 and PD-L2, release PD-1 pathway mediated inhibition of immune response, including anti-tumor immune response.
~Apatinib is a small molecule targeted anti-angiogenesis drug. It can highly selectively compete for ATP binding sites of endothelial growth factor R-2, block downstream signal transduction and inhibit neovascularization in tumor tissues."
15846079|NCT04074551|Drug|HCP1701|HCP1701
15846080|NCT04074551|Drug|Losartan|Losartan
15846081|NCT04074551|Drug|Amlodipine|Amlodipine
15846082|NCT04074551|Drug|Rosuvastatin and Ezetimibe|Rosuvastatin and Ezetimibe
15846083|NCT04074512|Drug|Copper Histidinate|Restoring Copper Histidinate levels normally found in the blood to assist in the maintenance of copper homeostasis.
15846084|NCT04074499|Other|No intervention|There is no intervention.
15846088|NCT04074473|Drug|propranolol|Propranolol 10mg BID initially and titrate dosage every week to achieve 25% drop of heart rate (keep heart rate>55 or systemic blood pressure>90mmHg)
15846089|NCT04074473|Procedure|Esophageal varice ligation|Esophageal variceal ligation every 3-4 weeks to achieve variceal eradication under endoscopy
15846090|NCT04074473|Other|DC propranolol|Patients randomized to banding ligation group discontinue propranolol after eradication of esophageal varices.
15846091|NCT04074460|Drug|Propofol|General Anaesthesia
15846092|NCT04074460|Drug|isoflurane, sevoflurane or desflurane|General Anaesthesia
15846093|NCT04074434|Device|Study Watch|Study Watch is a miniaturized physiological data monitoring and data collection device for continuous recording of physiological and environmental data
15846094|NCT04074421|Drug|Rifaximin|A non-aminoglycoside intestinal antibiotic, 400mg, twice one day for 2 weeks.
15846095|NCT04074421|Drug|Probiotic Formula|A probiotic called Enterococcus faecium, 500mg, triple one day for 4 weeks.
15846096|NCT04074421|Drug|Placebo oral tablet|Placebo oral tablet that has no therapeutic effect
15846097|NCT04074408|Procedure|stereotactic surgery|stereotactic aspiration surgery
15846098|NCT04074408|Biological|hUMSCs|single intracavitary infusion 1 day after stereotactic aspiration surgery
15846099|NCT04074408|Biological|placebo|single intracavitary infusion 1 day after stereotactic aspiration surgery
15846101|NCT04074382|Other|Qualitative Interviews|We will undertake qualitative interviews (remote or face to face) to shed more light on reasons for functional outcomes after trauma
15846102|NCT04074369|Diagnostic Test|CRISPR-based Test|CRISPR-based Test performed on sputum or BALF in TB suspects.
15846103|NCT04074356|Other|Clinical measure questionnaires|Collection of patient reported symptoms and perception of health
15846104|NCT04074356|Diagnostic Test|EESG|Use of silver-silver chloride cutaneous electrogastrogram (EGG) electrodes to get myoelectrical readings
15846105|NCT04074356|Diagnostic Test|MESG|MESG measures spatiotemporal properties of magnetic fields from the esophageal slow wave and allows characterization of the propagation of the slow wave in addition to evaluation of its frequency and power distribution
15846106|NCT04074356|Diagnostic Test|High resolution manometry (HRM)|Dysphagia subjects will have undergone standard of care HRM to determine placement in the achalasia or hypercontractile/spastic disorder arms
15846107|NCT04074343|Drug|TAS-102|Given PO
15846108|NCT04074343|Drug|Irinotecan|Given IV
15846109|NCT04074330|Drug|TAK-981|TAK-981 intravenous infusion.
15846110|NCT04074330|Drug|Rituximab|Rituximab intravenous infusion.
15846111|NCT04074317|Drug|PRAM9|SC injection
15846112|NCT04074317|Drug|Regular Insulin + Pramlintide|Separate SC injections
15846113|NCT04074317|Drug|Regular Insulin|SC injection
15846114|NCT04074304|Other|I-HoME|A multi-component technology-based care intervention.
15846115|NCT04074265|Drug|Ropivacaine injection|Injection containing a mix of the above medications will be performed while the patient is still under general anesthesia, following wound closure, and will be injected evenly between the deep and superficial tissues in an extra-articular pattern (no injection of the synovium or capsule).
15846116|NCT04074265|Drug|normal saline|Injection containing normal saline will be performed while the patient is still under general anesthesia, following wound closure, and will be injected evenly between the deep and superficial tissues in an extra-articular pattern (no injection of the synovium or capsule).
15846117|NCT04074252|Device|Lofstrand Crutches|Device: Set of Lofstrand Crutches
15846118|NCT04074252|Device|Axillary Crutches|Device: Set of Axillary Crutches
15846119|NCT04074239|Other|Video triage|The operator at the Medical Helpline will offer the parent who's calling regarding the sick child to assess the child on video, as compared to the routine way; on the telephone.
15846120|NCT04074226|Procedure|Erector Spinae Plane block|The Erector Spinae Plane (ESP) block is a new block first described in 2016 which blocks terminal branches of the lower thoracic and lumbar nerve roots. It is performed by injection of local anesthetic in the fascial plane below the erector spinae muscle group.
15846121|NCT04074226|Procedure|Quadratus Lumborum Block|Ultrasound-guided QL block has been reported to provide effective analgesia in patients undergoing lower abdominal surgical procedures, including in patients undergoing abdominal hysterectomy. Ultrasound guidance offers a number of advantages, including the ability to visualize the anatomy, perform real-time navigation, and direct observation of local anesthetic spread. The QL block is performed via ultrasound-guided injection of local anesthetic in the fascial planes above or below the QL muscle
15846122|NCT04074213|Drug|Clozapine|Clozapine treatment
15846123|NCT04074200|Procedure|Open Inguinal Hernia Repair|With the patient under anesthesia, a single incision is made in the groin area. The hernia defect may be closed, as per the operating surgeon's standard of care (SOC). Mesh may be used to repair the hernia, as per SOC. The specific open approach may vary due to surgeon preference and patient characteristics. After the repair, the patient will be prescribed a 5 day supply of pain medication, as per SOC.
15846124|NCT04074200|Procedure|Laparoscopic Inguinal Hernia Repair|With the patient under general anesthesia, several small incisions are made in the groin area. Ports are placed, the abdomen is insufflated, and laparoscopic instruments as well as a laparoscope (a lighted scope used to visualize the hernia) are inserted to complete the repair. The hernia defect may be closed, as per the operating surgeon's standard of care (SOC). Mesh may be used to repair the hernia, as per SOC. The specific laparoscopic approach may vary due to surgeon preference and patient characteristics. After the repair, the patient will be prescribed a 5 day supply of pain medication, as per SOC.
15846125|NCT04074200|Device|Robotic-Assisted Inguinal Hernia Repair|With the patient under general anesthesia, several small incisions are made in the groin area. Ports are placed, the abdomen is insufflated, and the da Vinci Robotic Surgical System (Intuitive) is docked to the patient and used to complete the procedure. The hernia defect may be closed, as per the operating surgeon's standard of care (SOC). Mesh may be used to repair the hernia, as per SOC. The specific robotic-assisted approach may vary due to surgeon preference and patient characteristics. After the repair, the patient will be prescribed a 5 day supply of pain medication, as per SOC.
15846126|NCT04074187|Drug|Caplacizumab (ALX-0081)|Pharmaceutical form:Lyophilized powder for solution for injection Route of administration: IV (first dose), SC (all subsequent doses)
15846127|NCT04074187|Drug|Plasma exchange (PE)|Pharmaceutical form:Plasma (e.g. fresh frozen plasma) Route of administration: Plasma exchange
15846128|NCT04074187|Drug|Corticosteroid treatment (Methylprednisolone or prednisolone)|Pharmaceutical form:Solution for injection or Tablet Route of administration: IV or Oral
15846129|NCT04074187|Drug|Immunosuppressive treatment (eg, rituximab)|Pharmaceutical form:Solution for injection (depending on product) Route of administration: IV (depending on product)
15846130|NCT04074174|Drug|NNC0174-0833|NNC0174-0833 administered s.c. (subcutaneously, under the skin) once weekly for 12 weeks
15846131|NCT04074174|Drug|Oral contraceptive (OC) tablets|1 tablet daily on days 1-8 and days 79-86
15846132|NCT04074174|Drug|Acetaminophen|Single dose of acetaminophen as part of a standardised meal on day 1 and day 79
15846133|NCT04074161|Drug|Semaglutide|Dose gradually increased to 2.4 mg administered once weekly for 68 weeks
15846134|NCT04074161|Drug|Placebo (semaglutide)|Administered once weekly for 68 weeks
15846135|NCT04074161|Drug|Liraglutide|Dose gradually increased to 3.0 mg administered once daily for 68 weeks
15846136|NCT04074161|Drug|Placebo (liraglutide)|Administered once daily for 68 weeks
15846137|NCT04074148|Behavioral|Diabetes Prevention Education Program|An educational lifestyle modification program, offering 4 sessions of 30 minutes theory and 30 minutes practice each, total duration 6 months
15846138|NCT04074148|Behavioral|Diabetes Prevention Education brochure|An educational lifestyle modification brochure
15846139|NCT04074135|Drug|68-Gallium DOTATATE|68-Gallium DOTATATE, to be used in yearly PET/CT research scans
15846140|NCT04074122|Diagnostic Test|Adenosine and epinephrine, isoprenaline provocation|High-resolution electromechanical mapping at baseline and after provocative measures.
15846141|NCT04074109|Combination Product|Teleyoga|the yoga protocol will be delivered via a tablet computer to groups of participants
15846142|NCT04074109|Behavioral|In-person yoga|the yoga protocol will be delivered by a yoga instructor in the room to group of participants
15846143|NCT04074096|Radiation|Stereotaxic radiosurgery (SRS)|For patients randomised to arm B only: Upfront SRS of all lesions ≥5 mm in diameter (or ≥3 mm if other cerebral metastases >5 mm).
15846144|NCT04074096|Drug|Binimetinib Oral Tablet|All patients: binimetinib 45 mg PO BID.
15846145|NCT04074096|Drug|Encorafenib Oral Capsule|All patients: encorafenib 450 mg PO QD
15846146|NCT04074096|Drug|Pembrolizumab|All patients: pembrolizumab 200 mg IV Q3W
15846149|NCT04074070|Other|Ultrasound examination|Ultrasound examination of joints, tendons and entheses.
15846150|NCT04074057|Other|Conventional Cardiac Rehab Classes|conventional weekly CR programme lasting 8-12 sessions.
15846151|NCT04074057|Device|Heart Track|"Key components of Heart-Track are a heart rate sensor, a mobile app and a remote monitoring portal. The Heart-Track mobile app is synchronized/ connected to Polar heart rate sensor through bluetooth in order to provide continous heart rate monitoring when subjects are exercising. This is to ensure safety and exercise effectiveness."
15846152|NCT04074044|Behavioral|BHmApp|Use of BHmApp for bladder education and training in pregnancy
15846153|NCT04074031|Device|Transcranial Ultrasound Therapy (Exablate® 4000 Type 1.1)|The Exablate® 4000 Type 1.1 model designed for noninvasive ablation of brain tissue is an MRI-guided transcranial ultrasound system (MRgFUS). The goal of the Exablate Neuro system is to precisely guide the focus of the ultrasound energy on the target region. The focused ultrasound energy is then repeatedly transmitted to the target until the desired result is achieved. Targeting is performed using MRI acquired during treatment. The treatment process is constantly monitored by closed-loop thermal feedback in real time, under the supervision of the treating physician. Once targeting is complete, the treatment outcome is confirmed by MRI sequences immediately after treatment. The Exablate Neuro is compatible with Siemens 3 Tesla MRI.
15846154|NCT04074018|Other|Self-rehabilitation program|facial self-rehabilitation for a duration of 6 months
15846155|NCT04074018|Other|Conventional rehabilitation program|Conventional facial rehabilitation for a duration of 6 months
15846156|NCT04073992|Behavioral|cognitive behavioral treatment of insomnia|A behavioral modification program consisting of 8 clinic sessions focused on sleep hygiene, stimulus control, sleep restriction, and cognitive restructuring.
15846157|NCT04073979|Device|Mistral implantation|Mistral implant is implanted in the Tricuspid valve
15846158|NCT04073953|Drug|RPQ|The study will compare the individual enantiomers of Primaquine -R-(-)-PQ, S-(+)-PQ, and Placebo.
15846159|NCT04073953|Drug|SPQ|The study will compare the individual enantiomers of Primaquine -R-(-)-PQ, S-(+)-PQ, and Placebo.
15846160|NCT04073953|Drug|Placebo|The study will compare the individual enantiomers of Primaquine -R-(-)-PQ, S-(+)-PQ, and Placebo.
15846161|NCT04073940|Behavioral|Targeted Ballet Program|All classes will be offered in a set schedule convenient for all participants. Classes will be taught by the PI, who has extensive dance training expertise. The targeted ballet program consists of an initial period of dance movements while sitting in chairs (20min), followed by exercises holding onto the ballet barres mounted to the walls in the Neuroscience of Dance on Health and Disability Laboratory (20min), followed by locomotive dance movements (20min). The dance moves are based on the Ballet I Syllabus of the Royal Academy of Dancing and the Cecchetti Council of America, designed for eight-year-old students with no necessary previous training in ballet.
15846162|NCT04073927|Dietary Supplement|Sodium butyrate|"Sodium butyrate Class: Fatty acids Ingredients (100 g): Na-butyrate (50 g), acylglycerol (mono- di, -triacylglycerol; 42 g), bee wax (5 g), sodium alginate E401 (2 g), emulsifier (0.5 g).
~The capsules contain granulated sodium butyrate and are coated with a sodium alginate membrane."
15846163|NCT04073914|Behavioral|Type 1 Teamwork Program|Psychoeducational web program
15846164|NCT04073901|Other|Endocrowns|Adhesive monoblock restoration for pulpotomized primary molars
15846165|NCT04073888|Procedure|Semen collection|Semen collection for seminogram and spermocytogram
15846166|NCT04073875|Diagnostic Test|18F-GP1|18F-GP1 PET-CT scan
15846167|NCT04073862|Other|Stepped-Care TF-CBT|SC-TF-CBT will be administered to children meeting the inclusion criteria of the study. The treatment aims to improve daily function for trauma-exposed children and their families by way of stress-mastery exercises, coping skills and gradual exposure.
15846168|NCT04073849|Drug|EPOGEN® (epoetin alfa)|Active drug
15846169|NCT04073849|Other|Normal Saline|Placebo
15846170|NCT04073823|Device|Flexitouch Plus|Flexitouch Plus full arm and core treatment
15846171|NCT04073823|Device|Flexitouch Plus FT with software modification|Flexitouch Plus full arm and trunk/chest treatment
15846172|NCT04073810|Diagnostic Test|PET imaging|Coronary 68Ga-DOTATATE PET-MRI or PET-CT at baseline and 3 months
15846173|NCT04073810|Diagnostic Test|Coronary CT angiography|CTCA at baseline and 2 years
15846174|NCT04073797|Drug|PCSK9 inhibitor|PCSK9 inhibitor
15846175|NCT04073797|Diagnostic Test|68Ga-DOTATATE PET-MRI|68Ga-DOTATATE PET-MRI at baseline and 12 weeks
15846176|NCT04073784|Drug|Gemcitabine combined with Aptinib and Toripalimab|"Gemcitabine injection, gemcitabine 1000mg/m2, Day 1 and Day 8 of each 21 day, maximum 6 cycles.
~Apatinib for oral administration, 250mg, once a day. Apatinib maintenance.
~Toripalimab injection, 240mg, Day 1 each 21day. Toripalimab maintenance."
15846177|NCT04073771|Device|Continuous renal replacement therapy with oXiris|Continuous renal replacement therapy with oXiris in patient with septic shock
15846178|NCT04073758|Drug|Dexmedetomidine|Comparing effects of remifentanil versus dexmedetomidine
15846179|NCT04073745|Other|Quality-of-Life Assessment|Ancillary studies
15846180|NCT04073745|Other|Questionnaire Administration|Ancillary studies
15846182|NCT04073719|Dietary Supplement|Apple Cider Vinegar|Will drinking apple cider vinegar increase urinary citrate levels to a greater degree than other beverages and which beverages produce the most significant effects compared against one another.
15846183|NCT04073719|Dietary Supplement|Other Beverage|To what degree do other high citrate beverages impact urinary citrate output.
15846184|NCT04073706|Procedure|TH BSO with SNB Note: If participants (≤45 years of age) wish to retain their ovaries a BSO may be omitted.|"Removal of uterus, tubes and ovaries with a sentinel node biopsy. A tracer dye (ICG) is injected into the surroundings of the primary tumour, it is transported via local lymphatic channels towards the draining lymphatic basin, and the first node that the tracer reaches is called the sentinel node. These one or two nodes are thought to be first involved with cancer spread."
15846185|NCT04073706|Procedure|TH BSO without retroperitoneal node dissection Note: If participants (≤45 years of age) wish to retain their ovaries a BSO may be omitted.|Removal of uterus, tubes and ovaries without retroperitoneal node dissection
15846186|NCT04073693|Dietary Supplement|Branched chain amino acids (BRCA)|They were with BRCA during the day apart of following the standard recommendations
15846187|NCT04073680|Drug|Serabelisib|Subjects will be dosed with Serabelisib on 3 consecutive days a week in a 28 day cycle until tumor progression. in combination with Canagliflozin 300mg, both are oral medications
15846188|NCT04073680|Drug|Canagliflozin 300mg|All subjects will be dosed with 300 mg canagliflozin in combination with serabelisib
15846189|NCT04073667|Behavioral|Exercise|"Specific Exercises:
~a. Exercises for cervical flexors: Objectives are summarized below:
~To increase the endurance and strength of cervical flexors. b. Exercises for cervical extensors:
~Training of craniocervical extensors and rotators with the cervical spine in the neutral position, c. Axiocapular muscles;
~Teaching the correct scapular position, D. Postural correction exercises;
~Teaching the neutral spine position from the first treatment session, 2) Sensorimotor Exercises:
~a. Joint position sense:
~Participants are trained to point their heads in different directions with the help of an illuminated band that is attached to the head with the eyes open at the beginning.
~b. The sense of cervical movement, c. Oculomotor control exercises, 3) Balance and coordination exercises;
~a. Balance training starts with static balance exercises and continues with dynamic balance exercises and walking exercises with different difficulty."
15846190|NCT04073654|Procedure|Placement of dental implants (surgical procedure)|The two study implants have to be placed in the same surgical session according to similar procedures. Implants will be placed in the planned anatomic sites by using a flapless or a miniflap approach. Implants sites will be prepared based on the bone density, and according to the manufacturers's instruction by using the 122 Taper kit (Osstem Implant).
15846191|NCT04073641|Other|No intervention|No intervention
15846192|NCT04073628|Device|Lighting Intervention|Lighting Intervention consisting of a cool or warm light source.
15846193|NCT04073615|Drug|Rivoceranib|Rivoceranib will be supplied as 100 mg and 200 mg film-coated tablets for oral administration.
15846194|NCT04073615|Drug|Trifluridine/Tipiracil|Trifluridine/tipiracil will be supplied as 15 mg trifluridine/6.14 mg tipiracil and 20 mg trifluridine/8.19 mg tipiracil tablets for PO administration.
15846195|NCT04073602|Drug|RC48-ADC|The eligible patients will be treated with RC48-ADC, an antibody-drug conjugate, 2.0 mg/kg, once every two weeks until investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first).
15846196|NCT04073589|Biological|ARGX-113 with rHuPH20|subcutaneous administration of efgartigimod with recombinant human hyaluronidase PH20 (rHuPH20)
15846197|NCT04073576|Device|AHCL|Closed loop algorithm contained in the MiniMed™ 670G 4.0 pump to be used in the study; includes a modified proportional integrative derivative (PID) model, with insulin feedback, an auto correction bolus feature and additional safety features.
15846198|NCT04073576|Device|SAP+PLGM|Sensor Augmented Pump (SAP) Therapy Mode with Predictive Low Glucose Management (PLGM), contained in the the MiniMed™ 670G 4.0 pump to be used in the study.
15846199|NCT04073563|Device|Infuse™ Bone Graft (Infuse™)|(Recombinant human bone morphogenetic protein-2 (rhBMP-2)/absorbable collagen sponge (ACS))
15846200|NCT04073563|Device|Capstone™ Spinal System and Medtronic posterior Fixation Systems|Capstone™ Spinal System and Medtronic posterior fixation systems
15846201|NCT04073550|Drug|Anlotinib|A multi-target receptor tyrosine kinase inhibitor.
15846202|NCT04073550|Drug|Placebos|Anlotinib blank analog capsule.
15846203|NCT04073550|Drug|Topotecan|A topoisomerase I inhibitor.
15846204|NCT04073537|Drug|Anlotinib|A multi-target receptor tyrosine kinase inhibitor.
15846205|NCT04073537|Drug|Placebos|Anlotinib blank analog capsule.
15846206|NCT04073537|Drug|Paclitaxel|Paclitaxel 175 mg/m^2 IV on Day 1 of each 21-day cycle.
15846207|NCT04073537|Drug|Carboplatin|Carboplatin area under the concentration curve (AUC) 5 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle.
15846208|NCT04073524|Other|Nature-Body-Mind-Community|The Nature-Body-Mind-Community (NBMC) approach has been developed in a pilot project over 2014-2018. The 'Wild man Programme' consists of the following main elements: 1. Nature environments and nature experiences, 2. Mind relaxation and meditation, 3. Body awareness and 4. Fire talks, storytelling and community spirit.
15846209|NCT04073524|Other|Treatment as usual|Treatment as usual consist of the rehabilitation offered by the hospital or municipality for the specific condition e.i. cancer, diabetes, COPD, anxiety, depression and stress
15846210|NCT04073511|Drug|Eungyosan|This drug is a commercially available drug, manufactured according to the Preparation of granules, General rule of formulation, Korean Pharmacopoeia. Dosage is 1 packet, 2.3g, 3 times daily, 6.9g total daily dose. The total duration of administration is up to 8 days.
15846211|NCT04073511|Drug|Samsoeum|This drug is a commercially available drug, manufactured according to MFDS regulations and the Preparation of granules, General rule of formulation, Korean Pharmacopoeia. 3.37g of a packet, 3 times a day, the total daily dose is 10.11g. Total duration of administration is up to 8 days.
15846212|NCT04073511|Drug|Placebo|It is composed of lactose carb, corn starch, caramel pigment, and ginseng flavor powder. It is brown granule and made to be recognized as Korean medicine. Take a total of 9.0g, 3.0g each, three times a day. The total duration of administration is up to 8 days.
15846213|NCT04073498|Drug|SerpinPC|Administered as IV infusion (over 30 minutes) or SC injection (abdomen) according to cohort dosing instructions.
15846214|NCT04073498|Drug|Placebo|Matching placebo administered by SC injection according to cohort dosing instructions.
15846215|NCT04073485|Procedure|Microwave ablation|Ultrasonogram is performed to identify the fibroid or adenomyoma. A trocar needle is placed into the lesion under local anesthesia. The MWA procedure is performed using appropriate microwave power and application time are selected to provide sufficient ablation coverage to the target lesion.
15846216|NCT04073472|Drug|mesenchymal stem cells (MSCs)|Allogeneic bone marrow derived mesenchymal stem cells (MSCs) direct injection to an ileal pouch fistula in the setting of Crohn's disease of the pouch
15846217|NCT04073459|Biological|DTwP-HepB-Sabin IPV-Hib|Intramuscular injection into the anterolateral area of the thigh
15846218|NCT04073459|Biological|Pentavalent vaccine and Salk IPV|Intramuscular injection into anterolateral area of the thigh
15846219|NCT04073446|Device|Spinal Cord Stimulation|Patients eligible for SCS
15846220|NCT04073433|Drug|MDMA|120 mg MDMA
15846221|NCT04073433|Behavioral|Psychotherapy|Non-directive psychotherapy conducted during MDMA-assisted psychotherapy session
15846224|NCT04073407|Dietary Supplement|AXA1957|Amino acids, food study
15846225|NCT04073407|Dietary Supplement|Placebo|placebo
15846226|NCT04073394|Behavioral|Diet Intervention|Mayo Clinic Diet
15846227|NCT04073381|Combination Product|Prehabilitation Program|This is a 4 week prehabilitation program which uses both exercise and nutrition. Exercise will be prescribed at least 6 days a week. Three days a week , for 45 mins, participants will be asked to perform body, leg and arm exercises against light resistance while wearing pneumatic blood flow restriction arm and leg bands. minutes. On the alternate days participants will walk approximately 15 minutes while wearing the leg bands that restrict blood flow. Additionally, a nutrition supplement cocktail will be provided and should be taken every day within 1 hour after completing each exercise session. The 4 Week Nutrition (Sports Drink) Supplement Cocktail: will include whey protein (25 g/day), creatine monohydrate (8 g/day), and L-citrulline (5 g/day). The supplement mixture will be provided in daily packages by the investigators (nutrition supplements are not regulated by the FDA)
15846228|NCT04073368|Dietary Supplement|AXA1957|Amino acids, food study
15846229|NCT04073368|Dietary Supplement|AXA1125|Amino acids, food study
15846230|NCT04073368|Dietary Supplement|Placebo|Amino acids, food study
15846231|NCT04073355|Behavioral|Physical Activity|Smartphone-delivered physical activity intervention
15846232|NCT04073342|Genetic|Gene expression of inflammatory mediator (Interleukin 8) and recognition receptor of Toll like receptor (TLR4).|Ileal tissue from both group will be tested for gene expression of inflammatory mediator (Interleukin 8) and recognition receptor of Toll like receptor (TLR4).
15846233|NCT04073329|Other|post operative measure of reduction|measurement was used to grade quality of reduction according to Matta's system . In accordance with prior studies, adequate (or anatomic) reductions with 0-1 mm of displacement were compared to inadequate (imperfect or poor) reductions with > 1 mm displacement . For the CT-based method, postoperative pre-digital (prior to 2000) and digital CT images were independently assessed in the axial, sagittal, and coronal planes, and residual gap and step displacement were measured along the articular surface at the level of the weight-bearing dome. Adequate reductions on postoperative CT were defined as < 1 mm step and < 5 mm gap displacement and inadequate reductions as ≥ 1 mm step and/or ≥ 5 mm gap displacement.
15846234|NCT04073316|Drug|Rivaroxaban 20 MG|Rivaroxaban intake, 20mg/day
15846235|NCT04073316|Drug|Warfarin|Warfarin intake, with target INR range between 2 and 3
15846236|NCT04073303|Biological|Botulinum Toxin Type A|Day 1 Administration of bilateral intramuscular injections into the masseter
15846237|NCT04073303|Other|Placebo|Day 1 Administration of bilateral intramuscular injections of placebo (normal saline) into the masseter
15846238|NCT04073290|Drug|Rifaximin 550 milligram Oral Tablet [XIFAXAN]|Rifaximin 550 milligram b.i.d. 72 hours before TIPS placement till 3 months post-TIPS
15846239|NCT04073290|Drug|Placebo oral tablet|Placebo b.i.d. 72 hours before TIPS placement till 3 months post-TIPS
15846240|NCT04073290|Drug|Lactulose 667 milligram/milliliter Oral Solution|Lactulose based on soft stool frequency, 72 hours before TIPS placement till 3 months post-TIPS
15846241|NCT04073277|Device|SCF-N-treated needles|The SCF-N-treated needles were used for acupuncture at LI 4 (Hegu) and LI 11 (Quchi) acupoints in the experimental groups..
15846242|NCT04073277|Device|Untreated needles|he untreated needles were used for acupuncture at LI 4 (Hegu) and LI 11 (Quchi) acupoints in the control groups.
15846243|NCT04073264|Procedure|monofilament|In the intervention group,monofilament absorbable suture,will be used.
15846244|NCT04073251|Dietary Supplement|KalobaTuss children|Syrup, dosage: 5 ml for 4 times a day for 8 days.
15846245|NCT04073251|Dietary Supplement|Placebo|Syrup, dosage: 5 ml for 4 times a day for 8 days.
15846246|NCT04073238|Device|Low-level Red-light Therapy|In addition to wearing single vision spectacle lens with power for correcting distance refraction, low-level red-light therapy is performed twice per school day at home with an interval of at least 4 hours, each treatment lasting 3 minutes.
15846247|NCT04073225|Device|MindPod Dolphin|"The immersive video game being tested in this study is called Bandit the Dolphin, developed by neurologist Dr. John Krakauer, and engineers in the Brain, Learning, Animation, and Movement Lab at Johns Hopkins. Bandit the Dolphin provides an oceanic environment in which the individual's arm movements control a simulated dolphin. The neuromotor effects of this game have been designed to be used in the clinical setting to rehabilitate arm and hand function following stroke. The game has further been modified to a Microsoft Kinect-based system and piloted for play in non-laboratory settings among community-dwelling adults. The game offers a unique combination of skilled arm movements plus varying levels of cognitive challenge. In this way, the individual's arms are challenged the same way the legs would be when walking in a complex, outdoor environment. Importantly, the participant plays while standing, thus engaging the whole body in this novel multi-sensorial experience."
15846248|NCT04073225|Device|Hand Bike|The control intervention in this study is a hand bike, a single-component upper-arm aerobic exercise device. This arm is innovative in its own right, by evaluating the benefits of upper arm aerobic activity on cognitive and physical health given that the vast majority of physical interventions focus on lower-extremity walking and biking exercise.
15846249|NCT04073212|Other|Dry Needling|Dry needling directly to the long head of the biceps tendon. The DN will be performed with disposable stainless-steel needles (.3 X 40mm; Seirin; Weymouth, MA) inserted into the skin over the most painful and/or thickened areas of the tendon, confirmed with palpation. Prior to insertion of the needle the overlying skin will be cleaned with alcohol. The needle will be inserted into the tendon. The technique will be a fast-in and fast-out technique described by Chiavaras et al.26 for 20-30 repetitions per session in up to 3 areas. An eccentric-concentric exercise program of the biceps muscle/tendon will follow each DN session and will be performed daily for the course of treatment and will be performed as described by McDevitt et al.
15846250|NCT04073212|Other|Heavy Slow Load Exercise|Eccentric exercise protocols have been found to be an effective treatment for tendinopathies of the upper and lower extremities and recent evidence supports heavy slow resistance training (including the addition of a concentric phase) as having better outcomes over eccentric exercise alone. Patients will use 1-5 pound weights to perform slow and controlled concentric and eccentric exercise to biceps muscle.
15846251|NCT04073212|Other|Rotator cuff and scapular stabilization exercise program|Both groups will be treated with a stretching and strengthening program. The rotator cuff and scapular stabilization strengthening and flexibility program used in this study has 3 phases and patients progress in phases based on their ability to perform a number of exercises using theraband or body weight resistance.
15846252|NCT04073212|Other|Soft tissue mobilization|Both groups will receive soft tissue mobilization to the anterior shoulder.
15846253|NCT04073199|Procedure|Long Lever Group|"the physiotherapist wears the limb passively towards flexion, external rotation and abduction until the physiotherapist has perception of stretch of the tissues (sensation terminal elastic firm according to the concept of Orthopaedic Manual Therapy for the soft tissue treatment) The patient's own weight stabilizes the proximal segment, in case that the scapula is not stable, the physiotherapist fixes with his free hand the scapula.
~The technique will be performed two days a week, at intervals of 20 seconds of technique and 20 rest periods for ten reps (estimated time per session is 7 minutes approximate)."
15846254|NCT04073199|Procedure|Short Lever Group|"It consists of a stretch made by the physiotherapist, with the patient in supine position, with the extremity to be treated in a submaximal position of flexion and external rotation (fixed by the arm and body of the physiotherapist) and realizing the stretch a through the scapula in the medial and caudal dorsal direction.
~The technique will be performed two days per week, at intervals of 20 seconds of technique and 20 rest periods for ten reps (estimated time per session is 7 minutes approximate)"
15846255|NCT04073186|Device|ACUVUE® OASYS with Transitions™|JJVC Marketed Contact Lens
15846256|NCT04073173|Procedure|INSURE|Patients will be intubated by endotracheal tube, exogenous surfactant (Poractant alfa) will be administered and then they will be extubated.
15846257|NCT04073173|Procedure|LISA|Surfactant (Poractant alfa) will be directly delivered into the lungs via a fine bore catheter inserted into the trachea and then patients will be extubated.
15846258|NCT04073173|Drug|Analgesic, Opioid|Remifentanil (0.5-2 micrograms/kg/dose)
15846259|NCT04073160|Drug|Tremelimumab|Tremelimumab and durvalumab will be administered in combination during cycles 1 and 2. Tremelimumab will be administered intravenously at a dose of 75 mg on cycle 1 day 1 and cycle 2 day 1. Cycles are 4 weeks long.
15846260|NCT04073160|Drug|Durvalumab|"Tremelimumab and durvalumab will be administered in combination during cycles 1 and 2. Durvalumab will be administered intravenously at a dose of 1500 mg on cycle 1 day 1 and cycle 2 day 1. Cycles are 4 weeks long.
~Eligible subjects may go on to receive a combination of durvalumab and bladder radiation during cycles 3 and 4. Durvalumab will be administered intravenously at a dose of 1500 mg on cycle 3 day 1 and cycle 4 day 1.
~At the completion of radiation, eligible subjects may continue to receive durvalumab for a maximum of one year from the date of their initial dose. Durvalumab will be administered intravenously at a dose of 1500 mg on the first day of each cycle."
15846261|NCT04073160|Radiation|Bladder radiation|During the durvalumab cycles 3 and 4, eligible subjects will receive 6.5 weeks of radiation to the bladder. Radiation will be administered at a dose of 64 Gy in daily 2 Gy fractions.
15846262|NCT04073160|Drug|Intravesicular Therapy|Subjects will receive intravesicular therapy, if clinically indicated during cycles 5 and beyond of durvalumab administration. Intravesicular therapy will consist of BCG, gemcitabine, mitomycin or a similar drug, depending on institutional standards and treating provider's discretion.
15846263|NCT04073147|Drug|Venetoclax|Venetoclax per os
15846264|NCT04073147|Drug|Obinutuzumab|ObintuzumabIV
15846265|NCT04073134|Biological|Evolocumab|Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.
15846266|NCT04073134|Drug|Placebo|Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.
15846267|NCT04073121|Device|Luminor DCB and Angiolite DES|Patient to undergo angioplasty with Luminor DCB and Angiolite DES
15846268|NCT04073108|Diagnostic Test|tuberculin test|tuberclin test used to diagnose tuberculosis as cause of fever of unknown origin
15846269|NCT04073095|Other|Erector spinae plane block (Group E)|"Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period.A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
~Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores at rest and during cough will be recorded at postoperative 1, 2, 4, 8, 16 and 24 hours. If the VAS score will be ≥ 4, 0.5 mg/ kg meperidine IV will be administered. The first time of the use of rescue analgesic, intraoperative and postoperative opioid consumption, side effects such as nausea, vomiting, itching and block related complications will be recorded."
15846316|NCT04072666|Behavioral|Suicide Prevention Pathway (SPP)|The standardised care approach involves a Suicide Prevention Pathway (SPP) modelled on the Zero Suicide Framework, utilising comprehensive chronological assessment of suicide events (CASE) (Shea, 2009) to elicit suicidal intent, the prevention orientated risk formulation (Pisani, Murrie, & Silverman, 2016), brief interventions conducted with the consumer during their initial assessment prior to the treatment setting (Stanley et al., 2016), Safety Planning Intervention, Counselling on Access to Lethal Means (CALM), brief patient/carer information, rapid, structured follow up, safe transitions of care and caring contacts (Fleischmann et al., 2008). The SPP is supported by a blended learning course with online and face-to-face training for staff.
15846270|NCT04073095|Other|modified-thoracolumbar interfascial plane block (Group T)|"Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period.A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
~Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores at rest and during cough will be recorded at postoperative 1, 2, 4, 8, 16 and 24 hours. If the VAS score will be ≥ 4, 0.5 mg/ kg meperidine IV will be administered. The first time of the use of rescue analgesic, intraoperative and postoperative opioid consumption, side effects such as nausea, vomiting, itching and block related complications will be recorded."
15846271|NCT04073069|Drug|The DR group|Miscible liquid of diprospan and ropivacaine in this study will be peri-incisional scalp infiltration with 0.5 ml diprospan, 15 ml 1% ropivacaine and 14.5 ml normal saline miscible liquids for participants who will undergo elective craniotomy. The local infiltration solution containing will be infiltrated along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigator.
15846272|NCT04073069|Drug|The R group|Miscible liquid of ropivacaine in this study will be peri-incisional scalp infiltration with 15 ml 1% ropivacaine and 15 ml normal saline miscible liquids for participants who will undergo elective craniotomy. The local infiltration solution containing will be infiltrated along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigator.
15846273|NCT04073056|Drug|Bupivacaine|Bupivacaine Hcl 0.25% Inj
15846274|NCT04073043|Behavioral|Telephone Coaching|Access to Telephone Coaching for a period of 12 weeks
15846275|NCT04073017|Dietary Supplement|Enterade®|Participants will drink an 8 ounce bottle of Enterade® twice a day for 4 weeks
15846276|NCT04073017|Other|Functional Assessment of Chronic Illness Therapy for Patients with Diarrhea (version 4.0)|Ancillary studies
15846277|NCT04073004|Behavioral|Rapid Resolution Therapy|psychotherapy that includes trance states
15846278|NCT04072991|Other|dietary therapy|participants will undertake a four week diet as part of their IBS treatment
15846279|NCT04072978|Device|Intraocular lens implantation|Implantation of an intraocular lens using either an anterior chamber IOL or a scleral fixated IOL using the modified Yamane technique.
15846280|NCT04072965|Other|balance training|Thirty five females with CAI will be recruited from the Faculty of Physical Therapy, Cairo University by announcements to participate in this study. The participants will be randomly assigned into three groups; (A) Cross Education will receive single leg balance training for the non affected side (n=10), (B) Traditional training will receive single leg balance training for the affected side (n=10), (C) control group will receive no intervention (n=15).
15846281|NCT04072952|Drug|ARV-471|Parts A and B: ARV-471 administered QD or BID for 28 day cycles.
15846282|NCT04072952|Drug|ARV-471 in combination with palbociclib (IBRANCE®)|Part C: Daily oral dosages of ARV-471 for 28 days in combination with palbociclib (IBRANCE®) for 21 days
15846283|NCT04072939|Other|Patients having had a lens surgery|Dilated fundus exam
15846284|NCT04072926|Drug|BioRoot|Influence of biomaterial BioRoot on periapical healing
15846285|NCT04072913|Other|Vaginal samples (biopsies + vaginal smear)|Two types of samples are envisaged: tissue (large biopsies, coin of conization or hysterectomy) to affirm the diagnosis and detect the matrix metalloproteinases and their tissue inhibitors by immunohistochemistry; cell sample (monolayer smear type) to evaluate the expression of oncogenic Human papillomavirus.
15846286|NCT04072900|Drug|Peptide|4 x 3 mg all the peptides given on days 84，87，91，98，105，133，and 161
15846287|NCT04072900|Drug|Anti-PD-1|3mg/kg, ivgtt, Q2w
15846288|NCT04072900|Drug|rhGM-CSF|3μg/kg given on Days 81，82，83，95，96，97，102，103，104，130，131，132，158，159，and 160
15846289|NCT04072900|Drug|Imiquimod 5% Topical Cream|topical application on the injection site 6 hours before each NeoAntigen peptides injection
15846292|NCT04072874|Drug|Experimental topical (Curaleish Topical)|Curaleish is a formulation in lotion and cream. Curaleish lotion and Curaleish cream will be applied topically by each participant in all lesion until day 28 or 42, depending on the regimen to be evaluated. Study staff will be closely observing the safety assessment. The application until Day 28 or 42 will continue, even if the lesion has shown 100% re-epithelization before day 28 or day 42.
15846293|NCT04072861|Drug|SnPP Protoporphyrin|Escalating doses of SnPP Protoporphyrin
15846294|NCT04072835|Drug|Etripamil NS|Patients will be provided with an ambulatory Cardiac Monitoring System (CMS) to help document PSVT episodes. The CMS will be self-applied by the patient, when PSVT symptoms begin. Patients will self-administer etripamil NS if vagal maneuver is ineffective. After an episode of PSVT where drug is administered, the patient will return to the investigative site for a study visit and will be given the option to continue in NODE-303 and manage subsequent episodes of PSVT with etripamil NS.
15846295|NCT04072822|Drug|Anakinra and Zinc|Anakinra is indicated for reduction in signs and symptoms and slowing the progression of structural damage in moderately to severely active rheumatoid arthritis. It has been previously studied in AH. Zinc is a nutritional supplement. Zinc supplementation reverses the clinical signs of zinc deficiency in participants with alcoholic liver disease.
15846296|NCT04072822|Drug|Prednisone|Prednisone is indicated for numerous conditions including inflammatory disease. Corticosteroids, such as prednisolone, are considered standard of care in alcoholic liver disease.
15846297|NCT04072822|Drug|Placebos|Matching placebo
15846298|NCT04072809|Other|No intervention|This study does not involve any interventions.
15846299|NCT04072796|Behavioral|Questionnaires|Short Form-36 (SF-36), Barthel Index (BI), Functional Ambulation Category (FAC), Mini-Mental Test (MMT) and Beck Depression Inventory (BDI) questionnaires
15846317|NCT04072653|Procedure|SLNB is spared|SLNB is spared in patients with negative preoperative axillary assessment(including LymphPET and other imaging examinations)
15846318|NCT04072640|Drug|Voriconazole 200mg|Induction treatment with voriconazole( 400mg/d)+5FC (100mg/kg/d) for 14 days;
15846300|NCT04072783|Diagnostic Test|MRI,DTI, functional MRI|"Patients will undergo testing with Pre- and and post-surgical MRI. The protocol will be Sagittal T1, Axial inversion recovery, T2, fluid-attenuated inversion recovery, susceptibility weighted image, diffusion weighted images, diffusion tensor imaging, resting state fMRI, sagittal 3D GRE / FFE or 3D T1 VIBE and tractography.
~Once patients are identified, surgery is planned.The standard of care procedures fall into two categories based on age of presentation, clinician judgement and family preference all other things being equal. Both the endoscopic-assisted craniectomy and open CVR are standard of care procedures. Patients self-select into these groups. None of the surgery nor any aspect of it is experimental.
~Patients are routinely examined for neurodevelopment pre- and post-operatively as part of American Cleft Palate Craniofacial Association guidelines.The Vineland Adaptive Behavior Scales are used up to and including age 4."
15846301|NCT04072770|Dietary Supplement|Pea|Proteins are intrinsically enriched with 15N and 2H. There are incorporated into mashed potatoes and the test meal is formulated to supply 30 g of pea protein per volunteer.
15846302|NCT04072770|Dietary Supplement|Casein|Proteins are intrinsically enriched with 15N and 2H. There are incorporated into mashed potatoes and the test meal is formulated to supply 30 g of pea protein per volunteer.
15846303|NCT04072757|Behavioral|Intervention Group|"Session One: Loving Food That Loves You Back - Food as Fuel
~connection nutrition and health Session Two: Myth busting: Fruits and Vegetables - delicious and affordable
~seasonal fruits & vegetables in the diet Session Three: No Time to Cook! Making nutritious meals that are fast and easy
~quickly make delicious/nutritious meals using minimal ingredients Session Four: Don't Eat Food You Can't Pronounce Except Quinoa; Eat Quinoa
~choose healthier foods Session Five: Taste Bud Rehab
~reduce foods high in sugar and salt.Mind-body connection Session Six: Batch & One Ingredient Cooking
~making large quantities to freeze; one ingredient cooking Session Seven: Sweet Tooth? Healthy Desserts
~prepare healthier desserts Session Eight: Family Meal Practices
~healthy eating habits in children Session Nine: Snacks as Mini Meals
~make nutritious snacks to keep energy up all day Session Ten: Revamp Your Favorite Recipe
~healthy up favorite recipes"
15846304|NCT04072757|Behavioral|Control Group|"The control group will not receive vouchers or nutrition education/skill building but will be exposed to any standard Griffin Hospital worksite offerings. A mini program (2 -4 hours) workshop will be offered to participants in the control group, and all intervention materials will be provided."
15846305|NCT04072744|Device|Heartfelt measurements|"The measurements taken using the Heartfelt device do not require contact with the participant. For the measurements to take place, the participant will simply walk in the field of view of the device. As the device(s) will have been installed at a location allowing the best view of where the participant goes in an out of bed, the participant is not expected to change anything to their routine.
~The device can also take measurements in the dark, so if the participant walks in front of the device in the dark, this information will also be captured.
~The Heartfelt device is a CE (European Conformity) marked product. Neither the participant, or the medical team will be able to see the data collected by the Heartfelt device during the study. They will be blinded to the data until each participant has completed the study. At that point they can choose to review the data from participant individually or wait until all the data from all participants is available."
15846306|NCT04072744|Device|Connected weighing scales|"The participant will be instructed to use those scales for the period of the study, as often as directed by their healthcare professional. The weighing scales display weight so that the participants can record the weight in their own heart failure records.
~The participant will be able to see the weight readings on the weighing scales during the study.
~The scales will communicate with the Personal Computer (PC) contained in the Heartfelt device and the data will be sent to the Heartfelt server through an encrypted link."
15846307|NCT04072731|Other|pathologic|All the enrolled patients were treated with whole resection and diagnosed by the Pathology Department based on the pathological evidence.
15846308|NCT04072718|Radiation|Radiotherapy|34 Gy/10#/2wk to the PTV and 40Gy/10#/2 Wk to the PTV SIB with IGRT using Rapid arc technique.
15846309|NCT04072705|Drug|General principles of care and judgement of researcher|Because our study will be performed by observational design, there will be no intervention for our study. Because it is a registry-based study, overall decision making for medications will be performed according to the general principles of care and judgement of researcher.
15846310|NCT04072692|Other|Hybrid rehabilitation training|Hybrid rehabilitation training is modified tendon gliding exercise with median nerve mobilization.
15846311|NCT04072692|Other|Traditional rehabilitation training|Traditional rehabilitation training uses traditional physiotherapy, such as splint, therapeutic ultrasound and electrotherapy.
15846312|NCT04072692|Other|Wearable anti-bowstringing orthosis (WABO)|WABO is a custom-designed orthosis to restrict the bowstringing effect of the flexor tendon in the carpal tunnel.
15846313|NCT04072679|Drug|Sintilimab+IBI305|It includes dose escalation and dose expansion stage. 6-9 subjects will be enrolled in dose escalation stage for the safety and efficacy evaluation. Then select specific dose of IBI305 +Sintilimab 200mg/kg, expand to 36-39 patients for the further safety and efficacy study.The study treatment lasts up to 24 months.
15846314|NCT04072666|Behavioral|Attempted Suicide Short Intervention Program (ASSIP)|The first session is based on a narrative interview with the consumer relating the personal story of how the point of attempting suicide was reached, videorecorded with consent. The second session involves the therapist and consumer watching the session together to reactivate the consumer's mental state during the crisis in a safe environment. Automatic thoughts, emotions, psychological pain and stress, and contingent behaviour are discussed. A psycho-educative handout is given to consumers. The third session involves discussing the handout. A credit card size leaflet is provided, with long term goals, individual warning signs and safety strategies listed, in addition to a card with crisis phone numbers. The sessions are followed by letters sent over 24 months (Michel, Valach & Gysin-Maillart, 2017).
15846315|NCT04072666|Behavioral|Cognitive Behavioural Therapy (CBT)|The intervention incorporates skills development and emphasises internal self-management. Therapy focuses on the identification of internal, external and/or thematic triggers for suicidal thinking and behaviours, as well as factors that maintain the desire to suicide, using thought records and/or chain analyses. Therapy aims to challenge distortions and misconceptions, including core beliefs that interfere with the motivation to initiate the process of problem solving and distress tolerance, by working on acceptance of emotional and/or physical pain. The final phase of treatment focuses on relapse prevention. CBT can challenge maladaptive beliefs, improve problem solving skills and social competence.
15846319|NCT04072640|Drug|amphotericin B deoxycholate (0.4-0.5mg/kg/d)|Induction treatment with 0.4-0.5mg/kg/d of Amphotericin B-deoxycholate +5FC(100mg/kg/d) for 28 days
15846320|NCT04072640|Drug|Amphotericin B-deoxycholate (0.7-1.0mg/kg/d)|Induction treatment with 0.7-1.0mg/kg/d of Amphotericin B-deoxycholate +5FC(100mg/kg/d) for 14 days
15846321|NCT04072601|Drug|Placebo oral tablet|Lactose monohydrate 50 mg, potato starch 45 mg, Gelatine 1,2 mg, Magnesium stearate 0,5, Talc 4,5 mg
15846322|NCT04072601|Drug|Atorvastatin 10mg|Tablet, can be adjusted to 2 tablets if tolerated
15846326|NCT04072562|Drug|AZD7594|"Treatment A: The study drug is a nebulizer suspension with strength 2.8 mg/mL using 2 mL in the device. The study drug is administered via oral inhalation.
~Treatment B: The study drug is a nebulizer suspension with strength 6.3 mg/mL using 2 mL in the device. The study drug was administered via oral inhalation.
~Treatment C: The study drug is an inhalation powder. The study drug was administered via oral inhalation."
15846327|NCT04072549|Behavioral|Free Summer Programming|The summer day camps are not singularly focused, such as sport camps or academic only camps. Rather, the camps provide indoor and outdoor opportunities for children to be physically active each day, provide enrichment and academic programming, as well as provide breakfast, lunch, and snacks. To standardize programming, the schools operate their camps on the same daily schedules which are developed by the same district-level personnel, with identical programmatic content delivered across all schools. The schools also provide the same meals to all children enrolled. The meals adhere to the Summer Food Service Program nutrition guidelines and are reimbursed through existing federal food programs.
15846328|NCT04072536|Device|Electric wheelchair with activated assistance module|This evaluation will be carried out in 3 standardized test circuits of increasing difficulty, one week apart. At each session, the patient will perform the circuit 6 times, including 3 with activated assistance
15846329|NCT04072536|Device|Electric wheelchair with assistance module not activated|This evaluation will be carried out in 3 standardized test circuits of increasing difficulty, one week apart. At each session, the patient will perform the circuit 6 times, including 3 with no activated assistance
15846330|NCT04072510|Behavioral|Self-esteem group|"The intervention will comprise of 6 sessions of group self-esteem therapy which uses a cognitive behavioural approach. The therapy has been manualised into a 76 page treatment protocol and will be administered by Assistant Psychologists employed at Newbridge House receiving weekly supervision from a Clinical Psychologist. The self-esteem group is based on Melanie Fennel's cognitive behavioural model of low self-esteem addressing thoughts, feeling and behaviours. The group aims to improve self-esteem and build positivity.
~The sessions are structured and laid out in the following overview:
~Week 1, Session 1: What is self-esteem and an introduction to CBT Week 2, Session 2: How might low self-esteem develop? Week 3, Session 3: Negative automatic thoughts Week 4, Session 4: Challenging negative automatic thoughts Week 5, Session 5: Creating new coping strategies Week 6, Session 6: Building positivity"
15846331|NCT04072510|Behavioral|Treatment as Usual|Treatment as usual refers to the standard inpatient treatment programme at Newbridge House which includes: individual therapy, occupational therapy, drama therapy, family therapy, dietetic support, nursing support, yoga and medication prescribed by a consultant psychiatrist.
15846332|NCT04072497|Biological|One shot of the zoster vaccine|One shot of the zoster vaccine (with live virus >=4.3 LgPFU per dose)
15846333|NCT04072497|Biological|One shot of the varicella vaccine|One shot of the varicella vaccine (with live virus >=3.3 LgPFU per dose)
15846334|NCT04072497|Biological|one shot of placebo|one shot of placebo with no live virus
15846335|NCT04072484|Other|Mild hypoxia|The subject will breathe a gas mixture containing 15% oxygen instead of 21% oxygen.
15846336|NCT04072471|Drug|Zurampic®|non-interventional study where patients are exposed to Zurampic® plus a xanthine oxidase inhibitor (allopurinol or febuxostat) during the normal course of clinical practice
15846337|NCT04072471|Drug|Control group: xanthine oxidase inhibitor monotherapy|non-interventional study where patients are exposed to xanthine oxidase inhibitor monotherapy (allopurinol or febuxostat) during the normal course of clinical practice
15846338|NCT04072458|Drug|L-Bcl-2 antisense oligonucleotide|There will be 2 planned dose levels, 20, and 40 mg/m^2. Successive cohorts of eligible patients with will be treated with BP1002. BP1002 is given as an intravenous infusion, twice weekly, as 8 doses per 28-day cycle. Cycles may be repeated every 4 weeks.
15846339|NCT04072445|Drug|Irinotecan|Given IV
15846340|NCT04072445|Drug|Irinotecan Hydrochloride|Given IV
15846341|NCT04072445|Drug|Trifluridine and Tipiracil Hydrochloride|Given PO
15846342|NCT04072432|Drug|Iron sucrose|single FeS infusion
15846343|NCT04072406|Other|Mindfulness meditation|Participants assigned to either condition who do not have a personal electronic device for listening to meditations or completing survey will receive a loaned device from the study team.
15846344|NCT04072406|Other|Usual care packet|Participants assigned to either condition who do not have a personal electronic device for listening to meditations or completing survey will receive a loaned device from the study team.
15846345|NCT04072393|Procedure|Home-based cardiac rehabilitation|-Patients will be evaluated by the clinical team at The Heart Care Institute (HCI). They will receive a heart rate monitor, blood pressure monitor, and weight scale that they will take home with them. They will receive training on how to use the heart rate monitor and blood pressure monitor. They will receive training on how to record their exercises and weights in the teleHeart application by an exercise physiologist from HCI. Within 6 weeks of completion of standard of care radiation therapy or cytotoxic chemotherapy (whichever is last), they will be prescribed a course of home-based CR by a cardiologist at HCI and be instructed on the regimen by an exercise physiologist from HCI.
15846346|NCT04072380|Drug|SUVN-G3031|SUVN-G3031 Tablets
15846347|NCT04072380|Drug|Placebo|Placebo Tablets
15846348|NCT04072367|Device|NeVa Stent Retrievers|thrombus removal
15846349|NCT04072367|Device|Solitaire Stent Retrievers|thrombus removal
15846350|NCT04072354|Drug|SEP-363856 50mg|SEP-363856 50mg tablet dosed once daily
15846353|NCT04072341|Drug|Propolis Period (Green Propolis 250mg/day)|Randomized, cross-over, open-label. Patients will go through two 4 week periods with 1 week washout between them. During the intervention period will use 250mg of green Propolis per day. In the control period they will only follow standard treatment for their comorbidities.
15846354|NCT04072341|Other|Control Period|In the control period they will only follow standard treatment for their comorbidities.
15846355|NCT04072328|Drug|Propofol|Propofol will be given 0.5 mg/kg bolus initially, and can be administered additionally after a least 30 secs if necessary.
15846356|NCT04072328|Drug|Midazolam|midazolam with propofol
15846357|NCT04072315|Drug|PLN-74809|PLN-74809
15846358|NCT04072315|Radiation|Knottin tracer|Radiotracer
15846359|NCT04072302|Drug|KAF156|100 mg tablet, 20 mg tablet, 50 mg tablet
15846360|NCT04072302|Drug|Placebo|100 mg tablet, 20 mg tablet, 50 mg tablet
15846361|NCT04072289|Device|Visumax spherocylindrical treatment|treatment of low cylinder (<0.75D)
15846362|NCT04072276|Biological|EV71 vaccine|EV71 vaccine with Adjuvant AlPO4 and the placebo (Adjuvant AlPO4 only) were randomly administrated to subject in CT-EV-21 study
15846363|NCT04072263|Biological|Tumor Infiltrating Lymphocytes (TIL)|Adoptive cell therapy using Tumor-Infiltrating Lymphocytes (TIL) i.v.
15846364|NCT04072263|Drug|Interferon Alfa 2A|Interferon alpha (IFNα) s.c., may work as a low toxic preconditioning regimens that creates the space required for the infused TIL but that it also supports the TIL by sustaining their persistence and indirectly their function, by upregulation of HLA class I on tumor cells and decreasing the numbers of regulatory T cells.
15846365|NCT04072263|Drug|Carboplatin|chemotherapy i.v.
15846366|NCT04072263|Drug|Paclitaxel|Chemotherapy i.v.
15846367|NCT04072250|Procedure|hepatectomy|Hepatectomy for patients with recurrent intrahepatic cholanigocarcinoma
15846368|NCT04072237|Biological|MarzAA (marzeptacog alfa [activated])|Single intravenous dose and ascending doses of subcutaneous injection of MarzAA (Coagulation Faction VIIa Variant)
15846369|NCT04072211|Biological|Engerix-B|Hepatitis B vaccine administered through intramuscular injection at 0, 1, and 6 months
15846370|NCT04072198|Drug|Nivolumab|240 mg every 2 weeks for 8 cycles followed by maintenance
15846371|NCT04072198|Drug|Bevacizumab|5 mg/kg every 2 weeks for 8 cycles followed by maintenance
15846372|NCT04072198|Drug|Irinotecan|165 mg/m2 every 2 weeks for 8 cycles
15846373|NCT04072198|Drug|Oxaliplatin|85 mg/m2 every 2 weeks for 8 cycles
15846374|NCT04072198|Drug|Leucovorin|200 mg/m2 every 2 weeks for 8 cycles
15846375|NCT04072198|Drug|fluoruracil|3200mg/m2 every 2 weeks for 8 cycles
15846376|NCT04072185|Other|Physical activity|TThe intervention group will participate in a group physical activity program for 4 months. It will consist of 60 minutes of walking sessions 2 days a week. The sessions will be directed by two referents of each primary care center. Also once a month, coinciding with the walk, you will visit some sociocultural municipal equipment to promote a community connection.
15846377|NCT04072172|Device|Mole Freckle Pen|Insulated micro steel needle use current: 5V / 1A of 5-speed free adjustment.5
15846378|NCT04072159|Behavioral|Community Pharmacists Vaccinating Against Cancer|Upon completing informed consent, parents of children who have received Dose 1 of the HPV vaccine at the recent clinical visit will be invited to participate in the study. Upon completing the demographic form and pre-test survey for the study, they will be randomized to intervention or control group. Participants in the intervention group will be asked to complete the additional vaccine doses with their community pharmacist. A provider from the participating clinic will electronically prescribe the HPV vaccine dose. Participants in the control group will be scheduled to return to the clinic (based on the vaccine schedule) to complete the vaccine series. The research team will conduct a follow-up survey six months after baseline for each participant. A sample (n=30) of intervention and control group participants will be invited to participate in an in-depth interview to gauge both parents' and children's' acceptability of this intervention.
15846379|NCT04072146|Drug|OC-01|Cross over bioavailability study
15846380|NCT04072146|Drug|Chantix|Cross over bioavailability study
15846381|NCT04072133|Behavioral|Meditative Movement|Intervention will be taught by a certified Tai Chi Easy (TCE) group practice leader. The TCE movements will be repeated in differing sequences and time-frames during the course of the study. The variety and combination of the exercises will begin easy and progress to more advanced movements and/or intensities as the study progresses and participants become more experienced and comfortable with the routine. Participants spend one hour in class each week for a total of eight weeks.
15846382|NCT04072107|Drug|sintilimab|Investigate whether capecitabine would be able to improve prognosis in patients at high risk groups
15846383|NCT04072107|Drug|Capecitabine|Investigate whether capecitabine would be able to improve prognosis in patients at intermediate risk groups
15846384|NCT04072094|Procedure|Minimally Invasive Locking Plate Fixation|Patients randomized to the Minimally Invasive Locking Plate Fixation arm will be treated with plate fixation. The plate may be applied in a percutaneous fashion. Any combination of locked and/or non-locked screws may be used.
15846385|NCT04072094|Procedure|Intramedullary Nail Fixation|Patients randomized to the Intramedullary Nail Fixation arm will be receive a standard locked intramedullary nail fixation. The nail must use at least one static interlock proximal to and one static interlock distal to the fracture site. The nail may be placed with a reamed technique.
15846386|NCT04072081|Device|Drug-coated balloon|Treatment of in suit coronary lesions with drug-coated balloon
15846387|NCT04072081|Device|Drug-eluting stent|Treatment of in suit coronary lesions with drug-eluting balloon
15846388|NCT04072068|Drug|Edoxaban|Every patient will receive every day edoxaban orally once a day. Edoxaban therapy will start after at least 5 days of lead-in with low-molecular-weight heparin, as per clinical practice. Edoxaban will be administered at dosage of 60 mg/day. In case of patients with body weight ≤60kg or with renal failure (creatinine clearance between 15 and 50 ml/min) or that are treated with P-gp inhibitors (cyclosporine, dronedarone, erythomycin, ketoconazole), dosage will be 30 mg/day. Patients will be treated for 6 up to 12 months with edoxaban, as per medical decision.
15846389|NCT04072055|Device|MOTO Medial|MOTO medial unicompartmental knee system
15846390|NCT04072042|Drug|Apatinib monotherapy|patients will receive Apatinib 250mg tablet by mouth, bid.
15846426|NCT04071665|Procedure|Modified lateral lumbar interbody fusion|Modified lateral lumbar interbody fusion
15846391|NCT04072029|Procedure|Phacoemulsification with intraocular lens implantation|Phacoemulsification (2.2mm coaxial, viscoelastic shield, experienced surgeon) with intraocular lens implantation (acrylic hidrophobic)
15846392|NCT04072016|Device|Beacon Aqueous Microshunt|The Beacon Aqueous Microshunt (BAM) is an implantable device intended to reduce intraocular pressure (IOP) in patients with refractory glaucoma by shunting aqueous humor from the anterior chamber to the surface of the eye.
15846393|NCT04072003|Device|intravascular ultrasound (IVUS)|use IVUS in the procedure
15846394|NCT04072003|Other|coronary angiography|Coronary angiography is required for all PCI procedure.
15846395|NCT04071990|Behavioral|FB-CBGT|CBGT for OCD patients, with Involvement of family members (partner, parent, sibling, ...)
15846396|NCT04071990|Behavioral|CBGT|CBGT for OCD patients, without involvement of family members
15846397|NCT04071977|Drug|Combined antioxidant therapy|It consists of a tablet with lutein (10 mg), astaxanthin (4 mg), Zeaxanthin (1 mg), vitamin C (L-ascorbic acid 180 mg), vitamin E (DL-alpha tocopherol 30 mg), zinc (zinc oxide 20 mg), copper (copper sulfate 1 mg), taken once a day for 12 months
15846398|NCT04071977|Other|Placebo|It consists in a capsule with 100 mg of magnesium oxide
15846399|NCT04071951|Behavioral|Pharmacist-led Hospital Discharge Care Intervention|"Pharmacists will address medication reconciliation, medication adherence, and polypharmacy issues as appropriate. Pharmacists will rely most on their prior training, but study investigators will also encourage the use of documentation templates with reminders, Beers list, deprescribing, motivational interviewing, the Medication Adherence and Literacy tool, and post-discharge phone calls.
~Pharmacists will assess patient needs and customize accordingly. All patients will receive one discharge counseling visit and one post-discharge phone call, but pharmacists will find that some patients need further phone calls, interventions, referrals, or other interactions. Some or all of the pharmacist activities may take place over the phone."
15846400|NCT04071938|Other|Teaching to GPs|Educational modules on bladder, bowel and skin-care, and pain management will be provided to participating GPs by Spinal Cord Injury specialists
15846401|NCT04071938|Other|Site visits to GP practices|Visits by specialized nurses to the participating GPs at their practices to support the establishment of specialized care on-site
15846402|NCT04071925|Procedure|Urethroplasty|Open reconstructive surgery to restore urethral patency in case of urethral stricture disease.
15846403|NCT04071899|Other|Scale vaidation|It's just filling a scale in order to validate it in French
15846404|NCT04071886|Behavioral|Mindfulness-Based Training|Mindfulness-Based Training comprises of mindful walking, body scanning and raisin meditation exercise. Participants will receive a guided session of mindfulness meditation, and will be asked to finish at least 30 minutes of Mindfulness-Based Training every day as homework as well as keep a diary describing their experiences and reflections. An expert in mindfulness practice will offer feedback and answer any questions online.
15846405|NCT04071886|Behavioral|Relaxation Training|Participants will listen to a 15-minute Relaxation Training tape twice a day.
15846406|NCT04071873|Diagnostic Test|Point-of-care HIV testing|Participants will undergo an HIV 1/2 antibody point of care test (Oraquick) and receive pre- and post-test counselling.Participants with positive tests will be referred to the HIV clinic for Western Blot confirmation, and linkage to care.
15846407|NCT04071873|Behavioral|HIV testing education|Participants will be provided with education on community based HIV resources.
15846408|NCT04071847|Device|Deep Brain Stimulation (DBS)|Deep brain stimulation therapy involves the delivery of electrical signals to targeted structures in the brain to modulate neural circuit activity, and has been used successfully for the treatment of various types of movement disorders, including Parkinson's disease (PD), disabling or essential tremor, and dystonia
15846409|NCT04071834|Diagnostic Test|ELISA|Detection of blood orphanin and norepinephrine in patients
15846410|NCT04071821|Drug|cetirizine HCl Gummy|cetirizine HCl 10mg in a gummy formulation
15846411|NCT04071821|Drug|Zyrtec tablet 10mg|cetirizine HCl 10mg tablet
15846412|NCT04071808|Diagnostic Test|ELISA Test|The levels of orphanin and norepinephrine in blood of diabetic patients with painless myocardial ischemia requiring interventional therapy and diabetic patients without interventional therapy were measured.
15846413|NCT04071795|Behavioral|Opt-Out Reminder|half will receive a clinical reminder that includes a standing NRT order and a referral to cessation counseling that will automatically generate unless the provider actively opts-out
15846414|NCT04071795|Behavioral|Opt-In Reminder|Half of the psychiatrists will receive a reminder that encourages the psychiatrist to offer cessation medications and referral to cessation counseling to patients interested in quitting
15846416|NCT04071769|Drug|Hyperpolarized 129 Xenon Gas Comparing Idiopathic Pulmonary Fibrosis (IPF) Treatment|Whether magnetic resonance imaging (MRI) using inhaled hyper-polarized 129 Xenon gas can help visualize impaired lung function to detect changes over time in Idiopathic Pulmonary Fibrosis (IPF) patients receiving approved IPF treatments
15846417|NCT04071756|Drug|Topical Tazarotene|This medicine works by making the skin less inflamed and reducing the thickness and pain from lesions of the skin
15846418|NCT04071756|Other|Placebo|A substance that has no therapeutic effect, used as a control in testing new drugs
15846419|NCT04071743|Device|gammaCore Sapphire|non-invasive vagus nerve stimulator
15846420|NCT04071743|Device|sham gammaCore Sapphire|sham gammaCore Sapphire
15846421|NCT04071730|Dietary Supplement|Immulina Dietary Supplementation|Immulina Dietary Supplementation is a highly standardized extract derived from various preparations of Spirulina, a cyanobacterium, marketed as a dietary supplement and has been utilized in several clinical studies describing its immunopotentiating properties.
15846422|NCT04071717|Behavioral|NIRS neurofeedback|Neurofeedback as a treatment for people which can be interpreted as a way to increase behavioral inhibition. A method to assess brain activity is functional near-infrared spectroscopy (NIRS), measuring hemodynamic correlates of neural activity.
15846423|NCT04071717|Behavioral|Sham NIRS neurofeedback|Sham NIRS neurofeedback
15846424|NCT04071691|Diagnostic Test|PET-MRI|SST2 PET-MRI scan
15846425|NCT04071678|Behavioral|Careful examination during endoscopic procedures to identify lesions|When the AI model alarms, check carefully to confirm the lesion
15846427|NCT04071652|Device|Mistral implantation|Mistral implant is implanted in the Tricuspid valve
15846428|NCT04071639|Drug|Haloperidol 2Mg Tab|Haloperidol take 0.5mg~2mg three time a day.
15846429|NCT04071639|Drug|Risperidone 1Mg Tab|Risperidone take 1mg once at night.
15846430|NCT04071639|Drug|Zoloft 50Mg Tablet|Zoloft take 50mg once in the morning.
15846431|NCT04071639|Drug|Idebenone|Idebebone take 30mg three times a day.
15846432|NCT04071639|Drug|Deutetrabenazine Oral Tablet [Austedo]|The recommended starting dose of Austedo is 6 mg administered orally once daily, and dose may be increased at weekly intervals in increments of 6 mg per day to a maximum recommended daily dosage of 48 mg.
15846433|NCT04071626|Drug|Ertugliflozin 5 mg|Ertugliflozin 5 mg once a day for 12 weeks
15846434|NCT04071626|Drug|Placebo oral tablet|Placebo oral tablet once a day for 12 weeks
15846437|NCT04071600|Drug|Neuropeptide Y|Intranasal
15846438|NCT04071600|Other|Placebo|intranasal
15846439|NCT04071587|Device|Brain Computer Interface training|Training with RecoveriX system.
15846440|NCT04071587|Behavioral|Control|Standard physiotherapy and occupational therapy according to clinical routines.
15846441|NCT04071574|Drug|Human Chorionic Gonadotropin (hCG)|Administration of hCG (10.000IU) for ovulation triggering
15846442|NCT04071574|Drug|Gonadotropins|Administration of Menotropin (hMG / FSH and LH at a 1:1 ratio) (150-225IU/day)
15846443|NCT04071574|Drug|GNRH-A Triptorelin|Administration of Triptorelin (0.1mg/day)
15846444|NCT04071574|Drug|GnRH antagonist|Administration of cetrorelix (cetrotide) or ganirelix (orgulatron) (0.25mg/day)
15846445|NCT04071561|Other|Posterior retroperitoneal adrenalectomy (PRA)|Minimally invasive adrenalectomy procedure
15846446|NCT04071561|Other|Lateral transperitoneal adrenalectomy (LTA)|During posterior retroperitoneal adrenalectomy, the failure to progress or the difficulty of creating or maintaining a pneumoperitoneum are reasons why conversion occurs.
15846447|NCT04071548|Other|HIIT Exercise|"HIIT exercise bike protocol
~3 minute warm up
~Intervals of 10x 60 sec of 80-95% of heart rate reserve Heart rate reserve = Max Heart rate - Resting Heart rate § Max heart rate = 220-age
~10x60 second Recovery period
~5 minute cool-down"
15846448|NCT04071535|Device|sudoscan、nerve conduction tests|To evaluate sudomotor nerve and macrofibropathy.
15846449|NCT04071522|Other|no intervention|no intervention
15846450|NCT04071509|Device|Percutaneous Lung Biopsy|Patients will undergo the usual biopsy procedure with a fine needle inserted through a larger guide needle, under CT guidance; at the end of the biopsy, the MIPP-Kit will be introduced through the same guide needle. The guide needle and the MIPP Kit will be retracted together slowly, whilst injecting BioGlue in appropriate amounts along the whole track, from the lesion to the skin.
15846451|NCT04071496|Other|Blood samples|1 dry tube of 5 ml, 3 citrated tubes of 5 ml, 1 tube citrate dextrose acid of 7 ml
15846452|NCT04071483|Procedure|Cervical transforaminal epidural steroid injection|Cervical transforaminal epidural steroid injection is a useful option in the diagnosis and treatment of cervical radicular pain.
15846453|NCT04071470|Behavioral|Storytelling|Couples in the storytelling intervention will receive 3 storytelling sessions- the couple can include any family or friends who they feel could support them during their treatment. Stories will include stories of couples who are supportive, those who experience difficulties, and families who do/do not support their use of PrEP
15846454|NCT04071470|Drug|PrEP|Patients at risk of HIV acquisition will be provided PrEP medications and counseling in ANC
15846455|NCT04071457|Drug|Lenalidomide|Commercially available intervention
15846456|NCT04071457|Drug|Daratumumab/rHuPH20|SWOG-Held IND
15846457|NCT04071444|Other|Baduanjin program|The entire program continued for 6 months (December, 2018 to July, 2019), and the intervention was performed for 60 min 3 times per week; particular attention was paid to the disease characteristics of the patients with chronic schizophrenia and to preventing excessive fatigue. Every session began with a 20-min warm-up, followed by 20 min of Baduanjin program, and ended with a cool-down session. The participants were instructed, with the assistance of a video, to practice Baduanjin program in a group by two authors who are experienced in the psychiatric nurses and had been trained in this program.
15846458|NCT04071431|Other|Result masking|"The quality control system randomly shows the RFQ result to the endoscopists and keep 50% of the RFQ results are not known (deliberately showing N/A) by the endoscopists before and during the endoscopy."
15846459|NCT04071418|Radiation|3D-printing Template-assisted CT-guided I-125 Seeds Implantation|(1) positioning and preoperative plan design;(2) 3D printing template design and production;(3) reset and seeds implantation;(4) intraoperative optimization;Postoperative dose verification.Dosimetric parameters include: dose D90 and D100 reaching a certain percentage target volume; Target volume V100, V150 and V200 reaching a certain percentage of prescribed dose;And the dose of organs at risk: Dmean, D2cc, d0.5cc, d0.1cc. Regular follow-up was conducted after treatment.
15846460|NCT04071405|Other|Non-intervention|Non-intervention observational study
15846461|NCT04071392|Procedure|Hysterosalpingogram (HSG)|An infusion pump delivered saline via balloon catheter under continuous pressure monitoring. After one minute, investigators withdraw the fluid and recorded volumes in and out. Subjects then undergo hysterosalpingogram (HSG) for evaluation of tubal patency.
15846462|NCT04071379|Biological|Recombinant Hepatitis B + DTP-HB-Hib|1 dose of 0.5 ml Recombinant Hepatitis B + 3 dose of 0.5 ml of DTP-HB-Hib
15846463|NCT04071379|Biological|Hep B + Pentabio (registered)|1 dose of 0.5 ml Recombinant Hepatitis B (registered) + 3 dose of 0.5 ml of Pentabio (registered)
15846464|NCT04071366|Drug|Itacitinib|Itacitinib 200 mg once daily for 30 days.
15846465|NCT04071366|Drug|Immune effector cell therapy|Participants will receive IEC therapy that is approved by the health authority in the country where the study is being conducted for any approved hematologic indication.
15846466|NCT04071353|Drug|Interferon|Interferon combined with ribavirin antiviral therapy
15846467|NCT04071353|Drug|ribavirin|Interferon combined with ribavirin antiviral therapy
15846468|NCT04071353|Drug|DAAs|DAAs antiviral treatment
15846469|NCT04071340|Device|non-contrast MSCT|non-contrast multi-slice computed tomography
15846470|NCT04071340|Device|Abdominal ultrasonography|Abdominal ultrasonography
15846471|NCT04071340|Diagnostic Test|Urine analysis|Urine analysis
15846472|NCT04071340|Diagnostic Test|Urine culture|Urine culture
15846473|NCT04071301|Device|TENA SmartCare Change Indicator|"Each participating subject will be provided with a Change Indicator and absorbent products for the duration of the investigation. Nine types of absorbent products will be used to collect real-life measurement data in order to assess the mathematical algorithms involved in the TENA SmartCare Change Indicator. Each participating subject will be allocated to the type(s) that are considered most suitable.
~Gateways will be placed in the resident's rooms as well as in common areas, this to enable full measurement registration."
15846474|NCT04071288|Procedure|total laparoscopic hysterectomy and simultaneous incontinence surgery with benign causes|total laparoscopic hysterectomy and simultaneous incontinence surgery with benign causes; Burch colposuspension and mid-urethral sling operations for stress urinary incontinence
15846475|NCT04071275|Device|transcranial Direct Current Stimulation (tDCS)|tDCS is a non-invasive technique that allow the administration of low currents directly to the scalp. The currents affect the cortex, and result in changes to the membrane potential of neurons in the stimulated area. This in turn affects the tendency of those neurons to generate action potentials.
15846476|NCT04071275|Other|Mirror therapy|Mirror therapy is a behavioral technique that proven useful for the treatment of phantom pain, yet the analgesic effects are unfortunately moderate and not long lasting. The assumed underlying mechanism of mirror therapy treatment is the induction of neuronal plasticity in the opposite direction than the abnormal reorganization of the cortex (due to the amputation), and by that relive pain.
15846477|NCT04071262|Drug|Abemaciclib|Administered orally
15846478|NCT04071262|Drug|Abiraterone Acetate|Administered orally
15846479|NCT04071262|Drug|Prednisolone|Administered orally
15846480|NCT04071236|Drug|Avelumab|Given IV
15846481|NCT04071236|Drug|Peposertib|Given PO
15846482|NCT04071236|Other|Quality-of-Life Assessment|Ancillary studies
15846483|NCT04071236|Other|Questionnaire Administration|Ancillary studies
15846484|NCT04071236|Radiation|Radium Ra 223 Dichloride|Given IV
15846485|NCT04071223|Drug|Cabozantinib S-malate|Given PO
15846486|NCT04071223|Other|Quality-of-Life Assessment|Ancillary studies
15846487|NCT04071223|Other|Questionnaire Administration|Ancillary studies
15846488|NCT04071223|Radiation|Radium Ra 223 Dichloride|Given IV
15846489|NCT04071210|Dietary Supplement|Probiotic tablet|Probiotic tablet twice a day for 12 weeks
15846490|NCT04071210|Dietary Supplement|Placebo tablet|Placebo tablet twice a day for 12 weeks
15846491|NCT04071197|Device|Gastostomy-biliary tube|gastrostomy followed by ERCP with nasobiliary stent placement in the CBD with its distal end been exit from the previously performed gastrostomy instead of the nostril
15846492|NCT04071197|Device|External biliary diversion, internal biliary diversion and nasobiliary tube|All biliary diversion modalities other than gastrobiliary tube
15846493|NCT04071184|Drug|Alofanib|Five dose cohorts and expanded cohort will be included
15846494|NCT04071171|Drug|CVVH with Phoxilium® in the first 48h after randomization|After randomization into the Phoxilium®-group, CVVH will be initiated with Phoxilium® as a replacement fluid and maintained for 48h, respectively until the crossover. Anticoagulation is delivered as pre-filter RCA with Regiocit® (Gambro Lundia AB, Sweden). For antagonisation of Regiocit®, a calcium solution (calcium chloride, with or without magnesium chloride) will be used post-filter.
15846495|NCT04071171|Drug|CVVH with Biphozyl® in the first 48h after randomization|After randomization into the Biphozyl®-group, CVVH will be initiated with Biphozyl® as a replacement fluid and maintained for 48h, respectively until the crossover. Anticoagulation is delivered as pre-filter RCA with Regiocit® (Gambro Lundia AB, Sweden). For antagonisation of Regiocit®, a calcium solution (calcium chloride, with or without magnesium chloride) will be used post-filter.
15846496|NCT04071171|Drug|CVVH with Phoxilium® in the second 48h after randomization (after previous 48h with Biphozyl®)|48h post randomization, respectively after the cross-over CVVH will be continued with Phoxilium® for another 48h. Anticoagulation is delivered as pre-filter RCA with Regiocit® (Gambro Lundia AB, Sweden). For antagonisation of Regiocit®, a calcium solution (calcium chloride, with or without magnesium chloride) will be used post-filter.
15846497|NCT04071171|Drug|CVVH with Biphozyl® in the second 48h after randomization (after previous 48h with Phoxilium®)|48h post randomization, respectively after the cross-over CVVH will be continued with Biphozyl® for another 48h. Anticoagulation is delivered as pre-filter RCA with Regiocit® (Gambro Lundia AB, Sweden). For antagonisation of Regiocit®, a calcium solution (calcium chloride, with or without magnesium chloride) will be used post-filter.
15846498|NCT04071158|Biological|RSV Vaccine|RSV vaccine
15846499|NCT04071158|Biological|Tdap|Tetanus, Diphtheria, and Acellular Pertussis Vaccine
15846500|NCT04071158|Biological|Placebo|Normal saline solution for injection (0.9% sodium chloride injection)
15846501|NCT04071119|Drug|Oxytocin nasal spray|Participants administer the oxytocin (40 IU) twice a day for 5 - 7 days
15846502|NCT04071119|Drug|Placebo|Participants administer the placebo (40 IU) twice a day for 5 - 7 days
15846503|NCT04071106|Drug|Turmeric Extract|Patient will apply the treatment twice daily for 12 weeks and will be assessed clinically and by dermoscope weekly and by histopathology every 4 weeks
15846504|NCT04071106|Drug|Turmeric Extract in Olive oil|Patient will apply the treatment twice daily for 12 weeks and will be assessed clinically and by dermoscope weekly and by histopathology every 4 weeks
15846505|NCT04071106|Drug|Petrolatum|Patient will apply the treatment twice daily for 12 weeks and will be assessed clinically and by dermoscope weekly and by histopathology every 4 weeks
15846506|NCT04071106|Device|NB-UVB|Patients will receive 2 sessions of NB-UVB phototherapy and will be assessed clinically and by dermoscope weekly and by histopathology every 4 weeks
15846507|NCT04071106|Drug|calcipotriol/ Betamethasone|Patient will apply the treatment twice daily for 12 weeks and will be assessed clinically and by dermoscope weekly and by histopathology every 4 weeks
15846589|NCT04070300|Behavioral|Interval exercise|Aerobic interval training during 12 weeks 3 times a week: 4 x 4 minutes intervals at an intensity of 90-95% of VO2 peak and active breaks of 3 minutes between intervals.
15846508|NCT04071093|Other|Home Telemonitoring System (HTS)|The HTS consists of an App that daily collects measurements of weight, blood pressure, heart rate and symptoms (checklist of symptoms questions). The HTS processes the data and generates and sends an alert to the physicians if a risk situation occurs (measurements are outside of normal ranges). The App has also an educational functionality that allows learning about lifestyle, self-care and healthy habits for HF patients. For this purpose, the application: a) has a section that answers frequent questions, b) has a question and answer game about HF, and c) sends educational messages to the patients every day.
15846509|NCT04071080|Drug|fluorescein sodium|Fluorescein sodium in 500mL Gatorade
15846510|NCT04071080|Drug|Placebo|500mL Gatorade
15846511|NCT04071054|Diagnostic Test|Carnation Ambulatory Monitor (CAM)|7-day detection of arrhythmias with Carnation Ambulatory Monitor (CAM)
15846512|NCT04071041|Drug|Albumin Human|Administration of albumin 20%, 20g in 100ml (Albutein Instituto Grifols, S.A. Can Guasch 2, Parets del Vallès, 08015 Barcelona, Spain) intravenously every 12 hours for 4 days or until death, discharge or clinical stability if occurring before.
15846513|NCT04071028|Procedure|warm-water footbath|"All the participants in the intervention group were arranged to stay in an air-conditioned, quiet room from 5:30 to 6:30 p.m. on their menstruation days 1 and 2. After sitting quietly for 20 minutes, the participants in the footbath group received legs soaking from the heel to the Sanyinjiao (SP6) acupoint (above the ankle) 24 in 42 ℃ water with air bubbles and vibration given to the soles for 20 minutes, whereas the participants in the control group kept on sitting quietly without legs soaking during the additional 20-minute period."
15846514|NCT04071015|Device|Non-invasive monitoring|Comparing blood pressure measurement using the Biobeat non-invasive monitor to arterial line.
15846515|NCT04071002|Other|12 weeks physical therapy programme|The programme include contrast bath, bandage, massage, active exercises, resistive exercises.
15846516|NCT04070989|Device|THA|Pinnacle Acetabular Shell (Sector, Gription, no screws), AltrX Polyethylene Liner and Corail Femoral Stem
15846517|NCT04070976|Radiation|Hypofractionated therapy|All patients will be treated with an external beam of 37.5 Gray in 15 fractions (2.5 Gray / fraction). They will be treated once a day, 5 days a week. If photon energy 6 MV or 10 MV is used, the patient should be treated with a 4-field technique using the anterior/posterior field and 2 lateral fields. The specification of the dose is in terms of a dose to a point at or near the center of the target volume. For all field dispositions, the dose specification point is the common isocenter of all beams.
15846518|NCT04070976|Radiation|Standard therapy|All patients will be treated with external beam radiotherapy with 50 Gray in 25 fractions (1.8-2 Gray / fraction). They will be treated once a day, 5 days a week. If photon energy 6 MV or 10 MV is used, the patient should be treated with a 4-field technique using anterior/posterior fields and 2 lateral fields. The specification of the dose is in terms of a dose to a point at or near the center of the target volume. For all field dispositions, the dose specification point is the common isocenter of all beams.
15846519|NCT04070963|Other|HbA1C|To take additional blood test of HbA1C once patient consented to the study
15846520|NCT04070950|Other|Questionnaires|Two self-questionnaires
15846521|NCT04070937|Diagnostic Test|vestibular test 1|videonystagmography
15846522|NCT04070937|Diagnostic Test|vestibular test 2|video head impulse test
15846523|NCT04070937|Diagnostic Test|vestibular evoked myogenic potentials|vestibular evoked myogenic potentials to measure the function of otolith organs
15846524|NCT04070937|Diagnostic Test|audiometry|tonal liminar audiometric thresholds
15846525|NCT04070937|Diagnostic Test|CT and MR imaging of temporal bone|Ct and MR imaging of temporal bone
15846526|NCT04070937|Genetic|p.P51S mutation|analysis of presence of p.P51S mutation in COCH
15846527|NCT04070924|Other|Bandaid|Bandaid dressing
15846528|NCT04070924|Other|Conventional bulky soft tissue dressing|Conventional bulky soft tissue dressing
15846529|NCT04070911|Other|WATER|ORAL WATER
15846530|NCT04070911|Other|ICE APPLICATION|ICE APPLICATION
15846531|NCT04070898|Procedure|Remove urinary catheter after surgery|Remove bladder catheter after surgery
15846532|NCT04070885|Procedure|Blood sample|A dry tube of 7 ml of blood, two 4 ml EDTA tubes, a 4 ml heparinized tube and an 8.5 ml ACD-A tube will be collected from the patient.
15846533|NCT04070885|Procedure|Urine sample|The urine will be taken from three 15 ml tubes.
15846534|NCT04070872|Procedure|3D laparoscope|For laparoscopic camera system, a 10-mm ENDOEYE FLEX 3D Deflectable Videoscope (Olympus Corp., Germany) was used in the 3D group.
15846535|NCT04070872|Procedure|2D laparoscope|For laparoscopic camera system, a 10-mm 30º IDEAL EYES Laparoscope (Stryker, Kalamazoo, MI, USA) camera was used in the 2D group.
15846536|NCT04070859|Procedure|Internal Fixation of Glenoid Fractures|Internal Fixation via (Paltes & Screws, Tension bands. etc)
15846537|NCT04070846|Drug|[14C] LC350189|Carbon-14 labelded LC350189
15846538|NCT04070833|Dietary Supplement|Vitamin D|Dietary Supplement: Vitamin D-3 (cholecalciferol), 2000 IU Other Name: cholecalciferol
15846539|NCT04070833|Drug|Fish oil|Drug: Omega-3 fatty acids (fish oil) Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA])
15846540|NCT04070833|Dietary Supplement|Vitamin D placebo|Vitamin D placebo
15846541|NCT04070833|Drug|Fish oil placebo|Fish oil placebo
15846542|NCT04070794|Drug|Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fasting)|Fasting conditions: Each subject will receive a single dose of fixed dose combination Zemimet® SR Tab. 50/1000 mg with 240±2 mL of 20% glucose solution in drinking water after an overnight fasting for at least 8 hours.
15846543|NCT04070794|Drug|Gemigliptin/Metformin Hydrochloride Sustained Release 50/1000 mg(Fed)|Fed conditions: Each subject will receive a single dose of fixed dose combination Zemimet® SR Tab. 50/1000 mg with 240±2 mL of 20% glucose solution in drinking water at 30 minutes after the start of standardized HFHC breakfast.
15846544|NCT04070781|Drug|Itacitinib|"Itacitinib is a novel, potent, and selective inhibitor of the Janus Kinase (JAK) family of protein tyrosine kinases (TYKs) with selectivity for Janus Kinase 1 (JAK1). Itacitinib is an investigational product.
~Itacitinib 200 mg daily in 28-day long cycles"
15846717|NCT04069299|Diagnostic Test|Positron Emission Tomography (PET) Scan|PET scan is an imaging test using radioactive tracers.
15846792|NCT04068740|Procedure|Surgical treatment of valvular heart disease|Valve replacement or repair
15846545|NCT04070781|Drug|Tocilizumab|"Tocilizumab is a biologic medication currently approved to treat adults with moderately to severely active rheumatoid arthritis (RA), adults with giant cell arteritis (GCA), and children ages two and above with Polyarticular Juvenile Idiopathic Arthritis (PJIA) or Systemic Juvenile Idiopathic Arthritis (SJIA). Tocilizumab blocks the inflammatory protein interleukin 6 (IL-6). This improves joint pain and swelling from arthritis and other symptoms caused by inflammation.
~Tocilizumab 4 or 8mg/kg cycle 1 day 1 every 4 weeks in 28-day cycles"
15846548|NCT04070755|Drug|FMX-101|
15846549|NCT04070742|Drug|FMX101|
15846550|NCT04070729|Other|Placebo gel|Localized subgingival application
15846551|NCT04070729|Drug|Hyaluronic acid gel|Localized subgingival application
15846552|NCT04070729|Biological|Platelet rich fibrin|Localized subgingival application
15846553|NCT04070716|Procedure|3D laparoscope|For laparoscopic camera system, a 10-mm ENDOEYE FLEX 3D Deflectable Videoscope (Olympus Corp., Germany) was used in the 3D group.
15846554|NCT04070716|Procedure|2D laparoscope|For laparoscopic camera system, a 10-mm 30º IDEAL EYES Laparoscope (Stryker, Kalamazoo, MI, USA) camera was used in the 2D group.
15846555|NCT04070703|Behavioral|The Go for Exercise & Healthy Aging Project|Exercise and Cognition
15846556|NCT04070690|Procedure|Concentration of dialysate bicarbonate|Adjust the dialysate bicarbonate concentration
15846557|NCT04070677|Combination Product|Ziverel|Patients in treatments with radiotherapy alone (RT) or radiochemotherapy (RT-CH) with acute radiation-induced esophagitis grade 2 or superior according to the most recent CTCAE will received support treatment with ZIVEREL®
15846558|NCT04070625|Other|Communication book group|Communication book
15846559|NCT04070625|Other|Control group|Simple speech therapy
15846560|NCT04070612|Other|Blood sample|A blood sample of 2 times 2 to 5 ml additional maximum
15846561|NCT04070599|Biological|Collection of biological samples|A collection of biological samples will be carried out, with the remainders of the immunological samples taken on dry tube: the serum of the patients, taken at the initial diagnosis, will be kept frozen at -20 ° C.
15846562|NCT04070586|Device|4DCBCT images|Images are acquired and assessed offline
15846563|NCT04070573|Drug|acetylsalicylic acid|High risk pregnant women will be treated with daily aspirin during pregnancy.
15846564|NCT04070560|Procedure|Intact cord (≥ 180 seconds) resuscitation|Resuscitation performed in near proximity to the mother with umbilical cord uncut
15846565|NCT04070560|Procedure|Early (≤ 60 seconds) cord clamping|Resuscitation performed at a designated area after umbilical cord is cut
15846566|NCT04070547|Device|Transcutaneous vagal nerve stimulation|Non-invasive stimulation provided by transcutaneous electrical nerve stimulation device 4hours a day at 25Hz, 250 μs pulse width placed on tragus.
15846567|NCT04070547|Device|Sham stimulation|Sham stimulation will be performed using electrodes 4 hours a day placed on earlobe.
15846569|NCT04070521|Other|Observational EEG Monitoring|Subjects will be monitored with electroencephalogram (EEG) after arriving to the Emergency Department with suspected overdose
15846570|NCT04070495|Drug|KW-6356|A single oral dose will be administered at Day 1 and 15
15846571|NCT04070495|Drug|Clarithromycin|400mg, oral tablet (2 x 200mg), twice daily (BID), Day 8-28
15846572|NCT04070495|Drug|Rifampicin|600mg, oral tablet (4 x 150mg), once daily (QD), Day 8-21
15846573|NCT04070482|Other|Tenofovir exposure in utero and during breastfeeding|Exposed in utero and during breastfeeding to Tenofovir-containing antiretroviral drugs
15846574|NCT04070469|Drug|Amoxicillin|dosage of plasma concentration of amoxicillin
15846575|NCT04070456|Other|Tablet-based SDH tool|A tablet-based SDH tool, which integrates responses into the EpicCare electronic health record (EHR).
15846576|NCT04070443|Drug|Ponatinib|30mg/day; 6 months. Dose adaptation procedures are planned in case of toxicity.
15846577|NCT04070443|Drug|Imatinib|400 mg/day; at least 30 months (M7 to M36), then depending of MR4.5 . Dose adaptation procedures are planned in case of toxicity.
15846578|NCT04070430|Other|2 weeks of partial weight bearing on crutches|Following surgery, patients will be instructed by their surgeon to use crutches for 2 weeks, and will follow-up normally, as any patient would. Their crutch use will not impact the quality or style of their postoperative care in any manner. At their 6-week, 6-month, 12-month, and 24 months postoperative visit, the mHHS and NAHS scores will be collected and stored in a secure data system, REDCAPS.
15846579|NCT04070430|Other|4 weeks of partial weight bearing on crutches|Following surgery, patients will be instructed by their surgeon to use crutches for 4 weeks, and will follow-up normally, as any patient would. Their crutch use will not impact the quality or style of their postoperative care in any manner. At their 6-week, 6-month, 12-month, and 24 months postoperative visit, the mHHS and NAHS scores will be collected and stored in a secure data system, REDCAPS.
15846580|NCT04070417|Behavioral|Lifestyle Medicine|Lifestyle intervention with components including physical activity, diet, relaxation/mindfulness, sleep and socialisation
15846581|NCT04070391|Dietary Supplement|vitamin B6|oral administration
15846582|NCT04070391|Other|control|oral administration
15846583|NCT04070378|Drug|Daratumumab Injection|Daratumumab SC 1800 mg (daratumumab 1800 mg with rHuPH20 30,000 units) subcutaneous infusion
15846584|NCT04070365|Device|FLEX Vessel Prep System followed by angioplasty|Eligible Arteriovenous Fistula (AVF)/Arteriovenous Graft (AVG) will be treated with the FLEX Vessel Prep system followed by angioplasty.
15846585|NCT04070352|Drug|Fidaxomicin|patients who are receiving fidaxomicin are enrolled into the study, blood is obtained for analysis, EMR and outcome data collected regarding their CDI
15846586|NCT04070339|Other|transfontanelle ultrasound|cerebral blood flow investigation using transfontanelle ultrasound
15846587|NCT04070326|Drug|Lanadelumab|Participants will receive 150 mg dose of lanadelumab every 2 or 4 weeks, depending on the participants age, over the 52-week treatment period.
15846588|NCT04070313|Drug|S-1|Eligible patients will receive S-1 orally 80-120 mg/day (depending on patient's body surface area (BSA)) on day 1 to 28 in a 6-week cycle.
15846793|NCT04068740|Diagnostic Test|Virtual treatment|Virtual valve replacement or repair surgery
15846590|NCT04070287|Combination Product|SMART Pack|The SMART pack is a re-branded and repackaged box for HIV self-testing kits. The intervention aims to promote distribution of HIVST kits through in institutions, vocational centers, and social media platforms. The intervention would also include a referral systems, where participants provided with the HIV self-testing kits are provided with information with youth-friendly health facilities for uptake of testing for sexually transmitted infections. The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the SMART pack and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Yaba local government area in Lagos state.
15846591|NCT04070287|Combination Product|Luv Box|"The Luv box is packaged in two colors: blue and pink. The LUVBox would be made available in supermarkets, on-line stores, mini-marts, pharmacies, neighborhood stores and markets, for easy accessibility in hard to reach areas. The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the Luv Box and the location where the pack can be obtained for individuals who are interested.For this pilot study, the intervention will be implemented in Yaba in Lagos state."
15846592|NCT04070287|Combination Product|Bili Vibes|The HIV self-testing kits will be available for interested individuals at the community youth events. These events and information the HIV self-testing kits will be on flyers that would be promoted at community centers and schools. For this pilot study, the intervention will be implemented in Ngenevu/Bunker communities in Enugu state.
15846593|NCT04070287|Combination Product|BeterDoc|"The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the BeterDoc Safety Kits and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Ibadan, Dugbe and Agbowo in Oyo state."
15846594|NCT04070287|Combination Product|IUNGO|The intervention would be promoted using flyers at community events and schools. The flyers will provide information on the HIV self-testing kits and the location where the pack can be obtained for individuals who are interested. For this pilot study, the intervention will be implemented in Akure South, Orita-Obele, Ipinsa, Ilara Mokin and Ijare in Ondo state.
15846595|NCT04070274|Procedure|different types of surgery platforms|58 patients with lateral calcaneus surgeries are divided into the control group of 29 patients and the experimental group with 29 patients. The traditional lateral method and calcaneus lateral surgery platforms are separately applied in the groups.
15846596|NCT04070261|Other|iOS application usability test|user tasks, questionnaires, semi-structured interviews
15846597|NCT04070248|Other|No intervention|No intervention
15846598|NCT04070235|Drug|SH229 tablets|SH229 400 mg was provided in 4 tablets, 100mg each；SH229 600 mg was provided in 6 tablets , 100mg each；SH229 800 mg in was provided in 8tablets , 100mg each。
15846599|NCT04070235|Drug|Daclatasvir dihydrochloride|Daclatasvir dihydrochloride was provided in a single tablet of 60 mg.
15846600|NCT04070222|Other|Hysteroscopy|"Three groups of patients will be enrolled: Natural labour group, Cesarean scar group and Cesarean with diverticulum (PCSD) group;
~Hysteroscopy will be carried out for uterine cavity examine and the specimen collection for further microflora analysis and inflammation marker detection;
~ART will be carried out with standard protocol and the clinical outcome will be recorded;
~The primary outcome of the study is the comparation of species and communities of uterine microflora and inflammatory markers of the female uterus among three groups. The secondary outcome is biochemical pregnancy rate, clinical pregnancy rate, embryo implantation rate and live birth rate."
15846601|NCT04070209|Drug|Darolutamide (BAY1841788)|Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg.
15846602|NCT04070209|Radiation|SBRT|SBRT will consist of 2-5 fractions of highly targeted radiation therapy delivered every other day. The radiation component will be completed in 4-10 days.
15846603|NCT04070196|Diagnostic Test|Periplex|Periplex test strip will be used to examine the PD effluent for peritonitis, in addition to the routine leucocyte testing of PD effluent
15846604|NCT04070183|Behavioral|POST Facilitation|Advanced steps is initiated as a component of quality end-of-life care for frail elders and those whose death in the next 12 months would not be unexpected. The AS planning conversation is focused on goals of care to make timely, proactive, and specific end-of-life decisions. Ideally, these decisions are converted into medical orders that can be followed throughout the continuum of care. The Physician Orders for Life-Sustaining Treatment (POLST) program is the nationally recognized model for this stage of planning.
15846605|NCT04070183|Behavioral|Home Safety Evaluation|Nurse evaluation and education on how to improve safety at home for community dwelling older adults (examples of education and evaluation includes fall risks, fire and carbon monoxide (CO) detectors, transferring safety (e.g. in and out of the tub, bed, etc.) and others.
15846606|NCT04070170|Device|Low-level Laser Therapy|Low-level laser therapy is applied on premolars that will be extracted for treatment plan reasons
15846607|NCT04070170|Procedure|Orthodontic force|Mechanical loading is applied on premolars that will be extracted for treatment plan reasons and in canines for tooth movement
15846608|NCT04070157|Drug|Lofexidine|Lofexidine 0.18 mg tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.
15846609|NCT04070157|Drug|Placebo|Matching placebo tablets. Dosing will begin with 1 tablet administered every 5-6 hours, up to 4 times day. The dose may be titrated but not to exceed 4 tablets 4 times a day.
15846610|NCT04070144|Device|IQ-Tip(tm) system|Physician performs therapeutic or diagnostic lumbar puncture using Injeq IQ-Tip(tm) system
15846611|NCT04070131|Other|Horse-Assisted Rehabilitation|One hour weelky session of hippotherapy.
15846612|NCT04070118|Procedure|Measure niche thickness with ultrasound|in patients with previous cesarean section who applied to the emergency department with pain and underwent surgery; Measure niche thickness before operation
15846613|NCT04070105|Device|Compliant Adaptive Energy Storage and Return Foot|The primary concept of the CAESAR foot is to capture the energy at heel strike and then store it to be released at a later time when it can provide additional propulsive forces during walking. Each transtibial amputee will wear the CAESAR foot and perform various tasks in the lab.
15846614|NCT04070105|Device|Conventional Prosthetic Foot|This is a commercial prosthetic foot that has been prescribed to the individual
15846615|NCT04070079|Drug|Tenofovir Alafenamide|TAF 25mg once daily orally, for 48 weeks
15846616|NCT04070066|Other|Digital didactic environment|Students assigned to this group will receive access to a digital didactic environment where they will have at their disposal the exchange transfusion guide and a complete video explaining the indications, the preparation of supplies and the newborn for the procedure, the management of medical devices required and a step-by-step description of the exchange transfusion technique. Finally, the student will see an integrated clinical case. This video will be developed by the neonatology and paediatric medical education teaching team in the simulation laboratory of the university using neonatal high-fidelity simulators, a simulated mother and the necessary medical equipment and supplies.
15846617|NCT04070066|Other|• Simulated scenario|The educational intervention will be developed with the students, led by the neonatology teacher, in the simulation laboratory. For the training, neonatal high-fidelity simulators, clinical history and paraclinical exams, necessary supplies for the procedure, a simulated mother, a professional nurse and a nursing assistant will be available. Training will take place in individual skill stations (identification of indications, communication, management of medical devices and procedures) and in integrated clinical scenarios.
15846618|NCT04070053|Other|TheraPPP Pathway|"TheraPPP Steps:
~Step 1. All mechanically ventilated patients will have a height measured and documented. Step 2. Screening for HRF. Step 3. Initiate Lung Protective Ventilation (LPV). Step 4. Paralysis. Step 5. Prone Positioning."
15846619|NCT04070040|Drug|Camrelizumab|Camrelizumab(SHR-1210) 200mg, once every 2 weeks, each 4 weeks is 1cycle.
15846620|NCT04070027|Procedure|Total Hip Arthroplasty|Total hip arthroplasty following standard procedures.
15846621|NCT04070027|Other|Progressive Resistance Training|"Progressive resistance training based on available evidence on patients with hip osteoarthritis and designed in accordance with the American College of Sports Medicine (ACSM) recommendations for progression models in resistance training aiming at inducing muscle hypertrophy and increasing muscle strength and power."
15846622|NCT04070001|Drug|400 Mg Ibuprofen|1-dose 400-mg ibuprofen 1-hour before elastomeric separator placement
15846623|NCT04070001|Device|laser application|A single irradiation of laser after elastomeric separator placement
15846624|NCT04070001|Other|placebo tablets|Placebo lactose tablets 1-hour before elastomeric separator placement
15846625|NCT04069988|Behavioral|Baduanjin program|This exercise program aimed to increase patient participation and control their metabolic parameters and body mass index through Baduanjin program. The entire program continued for 6 months (March to October 2016), and the intervention was performed for 60 min 3 times for 12-weeks; particular attention was paid to the disease characteristics of the patients with chronic schizophrenia and to preventing excessive fatigue. Every session began with a 20-min warmup, followed by 20 min of Baduanjin program, and ended with a cool-down session. The participants were instructed, with the assistance of a video, to practice Baduanjin program in a group by two authors who are experienced in the psychiatric nurses and had been trained in this program.
15846626|NCT04069975|Other|Sedation|The group of patients who did endoscopies with or without sedation. (This is a choice of themselves)
15846627|NCT04069962|Behavioral|CGA coordination by geriatric team including intensive patient coaching and follow-up|In the intervention group, the CGA including geriatric recommendations for interventions will be coordinated by the geriatric team and will be complemented with patient coaching. This intervention aims to support patient empowerment by improving self-efficacy and supporting self-management of existing age-related problems before systemic therapy or occurring during systemic therapy, and includes an individual counselling session at start of systemic therapy to discuss the recommendations with the patient and to determine their priorities.
15846628|NCT04069949|Drug|sorafenib; toripalimab|Stage I: cohort A: sorafenib 400 mg qd+ toripalimab 240 mg d1; q3w cohort B: sorafenib 400 mg bid, toripalimab 240 mg d1; q3w Stage II: According to the expansion dose based on stage I, subjects are enlarged to 39.
15846629|NCT04069936|Biological|MILs™ - NSCLC|To evaluate the safety of MILs™ - NSCLC alone in subjects with locally advanced and unresectable or metastatic NSCLC
15846630|NCT04069936|Biological|nivolumab|To evaluate the efficacy of MILs™ - NSCLC in combination with nivolumab in subjects with locally advanced and unresectable or metastatic NSCLC
15846631|NCT04069936|Drug|tadalafil|To evaluate the efficacy of MILs™ - NSCLC in combination with nivolumab with or without tadalafil in subjects with locally advanced and unresectable or metastatic NSCLC
15846632|NCT04069923|Other|Magnesium-based Bone Void Filler|Given intraoperatively
15846633|NCT04069910|Other|Quality-of-Life Assessment|Ancillary studies
15846634|NCT04069910|Other|Questionnaire Administration|Ancillary studies
15846635|NCT04069910|Radiation|Stereotactic Radiosurgery|Undergo SRS/SRT
15846636|NCT04069910|Procedure|Therapeutic Conventional Surgery|Undergo standard of care surgery
15846637|NCT04069897|Drug|Botulinum toxin type A|Botulinum toxin 25 Allergan units in 0.5 ml Sodium Chloride (NaCl) 0.9 % Braun. Two injections, one in each side of the face, and targeting the sphenopalatine ganglion.
15846638|NCT04069897|Drug|placebo|0.5 ml Sodium Chloride (NaCl) 0.9% Braun. Two injections, one in each side of the face, and targeting the sphenopalatine ganglion.
15846639|NCT04069884|Radiation|regional nodal irradiation|external-beam radiotherapy (XRT)
15846640|NCT04069884|Radiation|WBI|Whole Breast Irradiation
15846641|NCT04069884|Radiation|chestwall XRT|chestwall irradiation
15846642|NCT04069871|Device|trans-cutaneous electrical nerve stimulation.|• Patients assigned to the EMS group received daily EMS sessions of both lower extremities starting from the second day for 5days.
15846643|NCT04069871|Device|Sham TENS|Patients in the control group will receive sham TENS.
15846644|NCT04069858|Drug|Switching to Generic Entecavir (Baracle®)|switching to Baracle® 1 mg (generic drug) in chronic hepatitis B patients taking Baraclude® 1 mg (brand drug)
15846645|NCT04069845|Drug|liposomal doxorubicin|intravenous liposomal doxorubicin
15846646|NCT04069832|Behavioral|Single-Session Consultation|A single, goal-directed consultation session based on Solution-Focused Brief Therapy (SFBT). SFBT is an evidence-based therapy approach that is primarily focused on the client's present problems and their immediate future. When using SFBT in a single-session the aim of the intervention becomes empowering the client to take the smallest possible steps towards their desired future.
15846718|NCT04069286|Drug|Oral Aroeira/ Amoxicillin/ Claritromycin|Oral Aroeira (Schinus terebinthifolius Raddi, 640mg/tablet) 1 tablet, twice day, 12/12 hours + Amoxicillin 2 tablets of 500mg, twice day, 12/12 hours, + Claritromycin, 1 tablet of 500mg, twice day, 12/12 hours, for 14 days.
15846647|NCT04069819|Drug|Cilostazol 50 MG Oral Tablet|Escitalopram,Selective serotonin reuptake inhibitor- Cilostazol, a selective phosphodiesterase 3 (PDE3) inhibitor, acts as an antiplatelet agent and has been widely approved for treatment of intermittent claudication with peripheral arterial disease and for secondary prevention of ischemic stroke.
15846648|NCT04069819|Drug|Escitalopram|Escitalopram 20 mg tablet once daily for 6 week
15846649|NCT04069819|Drug|Placebo|placebo
15846650|NCT04069806|Dietary Supplement|preoperative oral carbohydrate, preOp|Patients in the experimental arm will receive oral carbohydrate preparation at 2 hours prior to planned caesarian section.
15846651|NCT04069793|Device|Commercially available device|A commercially available and registered with the FDA prosthesis equipped with a powered single-degree of freedom wrist and powered hand.
15846652|NCT04069793|Device|Non FDA registered device|An experimental, non FDA registered prosthesis equipped with a multi function wrist and a powered hand.
15846653|NCT04069780|Procedure|Intravitreal injection (4mg/0.1ml)|"Injection will be performed in the operating room under complete sterile conditions Under topical anaesthesia. Intravitreal injection (4mg/0.1ml) of triamicinolone acetonide will be done using a 30-31 gauge needle at a distance of 3.5 mm from the limbus in aphakic or pseudophakic patients, and 4 mm in phakic patients. The needle will be then removed with application of cotton tipped applicator over the entry site.
~-IOP monitoring will be done at 15, 30 and 60 minutes following injection in all groups."
15846654|NCT04069780|Procedure|Superachoroidal injection (4 mg/0.1ml)|"Injection will be performed in the operating room under complete sterile conditions Under topical anaesthesia. Suprachoroidal injection (4mg/0.1ml) of triamcinolone acetonide will be done using a custom-made 30-31 gauge needle with a sleeve to prevent further penetration of the needle into the vitreous cavity. Injection will be done at approximately 4 mm from the limbus.
~IOP monitoring will be done at 15, 30 and 60 minutes following injection in all groups.
~UBM assessment will be done 24 hours following injection to confirm targeting of the suprachoroidal space."
15846655|NCT04069780|Procedure|Suprachoroidal injection (2mg/0.1ml)|"njection will be performed in the operating room under complete sterile conditions Under topical anaesthesia. Suprachoroidal injection (2mg/0.1ml) of triamcinolone acetonide will be done using a custom-made 30-31 gauge needle with a sleeve to prevent further penetration of the needle into the vitreous cavity. Injection will be done at approximately 4 mm from the limbus.
~IOP monitoring will be done at 15, 30 and 60 minutes following injection in all groups.
~UBM assessment will be done 24 hours following injection to confirm targeting of the suprachoroidal space."
15846656|NCT04069767|Procedure|ICoreDIST|"The intervention consists of exercises that demand enhancement of dynamic trunk stability and functional movements, combined with the following:
~Optimised alignment and adaptation to the base of support and often using an unstable reference point for the trunk (therapeutic ball) or the distal body parts.
~Enhanced somatosensory integration of hands, feet and face, including reduced influence of vision to enhance somatosensory integration.
~Proximal stability prior to selective task-oriented movement of limbs, head, eyes.
~Inclusion of dual tasks (motor/motor and motor/cognitive) in exercises and activities such as walking indoors, out-doors and climbing stairs.
~Specific hands-on interactions or other adaptations to optimise alignment and neuromuscular recruitment.
~Exercises combining core activation and moderate increase in heart rate: in lying, sitting, standing and walking."
15846657|NCT04069767|Procedure|Standard Care|According to national guidelines for stroke care, every patient in Norway will receive in-patient rehabilitation, home-based and out-patient based physiotherapy.
15846658|NCT04069754|Behavioral|Adapted Passport to Freedom|5 weekly, 90 minute group sessions that cover topics such as mindfulness, health, healthy relationships, family matters, and reflections.
15846659|NCT04069741|Other|Decision Aid|A website that contains information about de Quervain's tenosynovitis and the options for treatment
15846660|NCT04069741|Behavioral|Toolkit for de Quervain's|A website that offers 4 sessions of mind-body skills to help manage pain from de Quervain's tenosynovitis
15846661|NCT04069728|Other|Explanation with 3D printed fistula model|Explanation of fistula and surgery using a 3D printed model of an anal fistula that depicts the anatomy of the anal canal, the path of the anal fistula and its relation to anatomic structures.
15846662|NCT04069728|Other|Standard explanation|Explanation of fistula and treatment using words, diagrams and MRI images as per consultant choice. Standard clinical care.
15846663|NCT04069715|Dietary Supplement|Farlong NotoGinseng™ (Farlong Ginseng Plus® Panax Notoginseng extract)|A product made of highly concentrated pharmaceutical grade notoginseng root extract, and containing high potency bioactive components, notoginsenoside, ginsenoside Rb1, Rg1, Rd, Re and Rb2.
15846664|NCT04069715|Other|Placebo|Turmeric 0.4%, Rice Flour 76.6%, Magnesium stearate 23%, capsule shell (gelatin) 61 mg
15846665|NCT04069702|Behavioral|VR Blue|VR Blue provides patients with an immersive computer-generated environment that can reduce pain, tension and distress.
15846666|NCT04069689|Drug|EPX-100 (Clemizole Hydrochloride)|EPX-100 (Clemizole Hydrochloride)
15846667|NCT04069689|Drug|Placebos|Placebo to match EPX-100
15846668|NCT04069676|Other|EEG|EEG, ECG and EDR record during a behavioral task
15846669|NCT04069663|Other|No interventional study|Retrospective data analysis
15846670|NCT04069650|Procedure|Free flap|Free flap reconstruction of the oral cavity
15846671|NCT04069637|Combination Product|Growth-sparing instrumentation and titanium levels|Patients with growth-sparing instrumentation as treatment for early onset scoliosis, will have their titanium (serum and urine) levels tested, to evaluated if they have elevated titanium levels compared to a control group.
15846719|NCT04069286|Drug|Omeprazole/ Amoxicillin/ Claritromycin|Omeprazole 1 tablet of 20mg, twice day, 12/12 hours + Amoxicillin 2 tablets of 500mg, twice day, 12/12 hours, + Claritromycin, 1 tablet of 500mg, twice day, 12/12 hours, for 14 days.
15846675|NCT04069611|Other|Probiotic|Subjects in the test group will take two probiotic lozenges per day for 3 months (one in the morning and one in the afternoon after brushing their teeth), starting after the last session of SRP. Lozenges will contain L. reuteri (2 x 108 colony forming units/tablet of strains ATCC 55730 and ATCC PTA 5289; Sunstar GUM Periobalance).
15846676|NCT04069611|Other|Placebo|Subjects assigned to the placebo group will take lozenges exactly like the test ones but without bacteria.
15846677|NCT04069611|Procedure|Scaling and root planing|Mechanical debridement with US and curettes of hard and soft plaque deposits
15846678|NCT04069598|Diagnostic Test|Statin intolerance test|Statin intolerance test
15846679|NCT04069585|Device|RHA®1 with new anesthetic agent|A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w of new anesthetic agent in a physiologic buffer.
15846680|NCT04069585|Device|RHA®1-Lidocaine|A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
15846681|NCT04069572|Device|Vibrotactile Stimulation|Application of VCR stimulation to the belly and back of patients with pelvic pain, functional abdominal pain, or low back pain or to the temporal region for patients with migraine.
15846682|NCT04069572|Device|Sham Stimulation|Low-frequency sham of VCR stimulation
15846683|NCT04069559|Other|To develop nursing students' attitudes towards refugees program which based on contact hypothesis.|In the first three weeks, education were given to the intervention group about refugees. Students watched a film on the theme of migration. After than the students contacted refugees in three different centers ( an immigrant health center, a school and a civil Society Organization) each of them for a total of nine weeks and two days a week.
15846684|NCT04069546|Device|remote ischemic conditioning|RIC is a physical strategy performed by an electric device with cuffs placed on the unilateral arm and inflated to 180 mmHg for 5-min followed by deflation for 5-min, the procedures are performed repeatedly for 5 times.
15846685|NCT04069533|Biological|RP-L102|CD34+ enriched cells from subjects with Fanconi anemia subtype A transduced ex vivo with lentiviral vector carrying the FANCA gene
15846688|NCT04069494|Other|questionnaires|Two questionnaires in patients and another two questionnaires in carer.
15846689|NCT04069481|Other|Dance|One-hour class, twice a week. Classes include dance warm up exercises, various dance movements and choreography that include coordinated whole body movements through space synchronized to music.
15846690|NCT04069481|Other|Mindfulness meditation and Exercise|One hour class, twice a week. Classes include upper and lower extremity stretching and resistance exercises and mindfulness meditation, that includes body scan technique and breathing exercises.
15846691|NCT04069468|Device|TheraSphere|Participants will receive treatment with TheraSphere in accordance with Instructions for Use
15846692|NCT04069455|Other|Electronic Patients Reported Outcomes|ePRO is a application which is web based and accessible from home or mobile device, for patients to complete symptom reports and receive severity-based advice
15846693|NCT04069442|Other|This is a non-interventional study|This is a non-interventional study
15846694|NCT04069429|Radiation|Computerized Tomography scan|imaging scan from a person's eyes to their thighs
15846695|NCT04069429|Radiation|Single Photon Emission Computed Tomography scans|imaging scan taken during, and after, the administration of the radioactive agent
15846696|NCT04069429|Drug|Technetium Tc 99M|subjects are administered radioactive heparin as part of study participation.
15846697|NCT04069429|Radiation|Planar Images|2 dimensional imaging - whole body planar scans
15846698|NCT04069429|Procedure|Esophagogastroduodenoscopy|esophagogastroduodenoscopy with tissue biopsies
15846699|NCT04069416|Procedure|living donor liver transplantation|liver graft from a living donor
15846700|NCT04069403|Other|Automated Reports on prescription patterns for their patients|de-identified aggregate reports
15846701|NCT04069390|Device|CARDIOSKIN - Short record|A short record (max 2H15) is performed with Cardioskin
15846702|NCT04069390|Device|Cardioskin - long record|A long record (max 8H) is performed with Cardioskin
15846703|NCT04069390|Device|Neuronaute - long record|A long record (max 8H) is performed with Neuronaute
15846704|NCT04069390|Device|Neuronaute -short record|A short record (max 2H15) is performed with Neuronaute
15846705|NCT04069377|Device|LUCAS™ 2 Chest Compression System|LUCAS is a portable device designed to rule out the problems encountered during manual chest compression, capable of performing standard and continuous chest compressions at a depth of 4-5 cm and at least 100 times per minute.
15846706|NCT04069377|Other|Manuel chest compressions by human efforts|In this way chest compressions will be handled by humans themselves.
15846707|NCT04069364|Behavioral|TinnitusTipps|Self-helf tips for managing chronic tinnitus will be given via smartphones.
15846708|NCT04069351|Dietary Supplement|High-calorie mass gainer supplement|A high-calorie mass gainer supplement will be provided to all participants to promote weight gain.
15846709|NCT04069351|Other|Resistance Training|All participants will complete a 6-week supervised resistance training program.
15846710|NCT04069338|Procedure|Lithotripter|Patients receive standard of care treatment for their urolithiasis using one of two lithotripter machines
15846711|NCT04069325|Drug|simiaowan|pills, 6g twice daily (BID), oral, 12 weeks
15846712|NCT04069325|Drug|placebo|pills, 6g twice daily (BID), oral, 12 weeks
15846713|NCT04069325|Drug|febuxostat|tablets, 40 mg once daily (QD), oral, 12 weeks
15846714|NCT04069312|Drug|Roflumilast|Prescription for Roflumilast (250 mcg/day x 4 weeks, then 500 mcg/day or alternate regimen) x 6 to 36 months
15846715|NCT04069312|Drug|Azithromycin|Prescription for Azithromycin (250 mg/day, or 500 mg three times per week, or alternate regimen) x 6 to 36 months
15846716|NCT04069299|Drug|68Ga-DOTATATE|The NETspot kit is 2 vials, Vial 1 contains 40 mcg dotatate, 5 mcg 1,10phenanthroline; 6mcg gentisic acid and 20 mg mannitol. Vial 2 contains 60 mg formic acid, 56.5 mg sodium hydroxide and water for injection
15846723|NCT04069260|Drug|ELX-02|ELX-02 is a small molecule, new chemical entity being developed for the treatment of genetic diseases caused by nonsense mutations. ELX-02 is a eukaryotic ribosomal selective glycoside (ERSG).
15846724|NCT04069247|Behavioral|ECBT-I|The eCBT-I will be delivered through a mobile application (eSleep) with a personal password.
15846725|NCT04069247|Behavioral|HE|The HE will be delivered in control though a mobile application (eSleep) with a personal password.
15846726|NCT04069234|Drug|Ticagrelor|ticagrelor 60 mg BID for 30 days
15846727|NCT04069234|Drug|Clopidogrel|clopidogrel 75mg OD for 30 Days
15846728|NCT04069221|Drug|Single oral dose of 800 mg OZ439|Single oral dose of 800 mg OZ439
15846729|NCT04069221|Drug|Single oral dose of 400 mg OZ439|Single oral dose of 400 mg OZ439
15846730|NCT04069221|Drug|Single oral dose of cobicistat|Single oral dose of 150 mg cobicistat
15846731|NCT04069221|Drug|iv infusion of [14C]-OZ439|15-minute 10-mL iv infusion of 100 μg [14C]-OZ439
15846732|NCT04069208|Drug|Idarubicin and cytarabine induction|Idarubicin 14mg/m2 for 3 days cytarabine 100mg/m2 every 12 hour for 7 days
15846733|NCT04069195|Dietary Supplement|DHA supplement|Patient's will be randomized to recieve either DHA or 50:50 corn oil/soybean oil supplement as a once daily supplement to be taken from enrollment through delivery of their infant
15846734|NCT04069195|Dietary Supplement|Corn Oil: Soybean Oil|Patient's will be randomized to recieve either DHA or 50:50 corn oil/soybean oil supplement as a once daily supplement to be taken from enrollment through
15846735|NCT04069182|Behavioral|Behavioral Activation Therapy|Behavioral Activation Therapy (BAT) has its origins in Cognitive Behavioral Therapy. In BAT, the patient monitors his emotions and daily activities, as a behavioral element. It seeks to increase the number of pleasant activities and increase interactions with the environment. The BAT considers positive reinforcement as the main intervention strategy. The treatment focuses on helping patients to systematically increase contact with their life's reward sources and solve their problems through procedures that focus on activation and on processes that inhibit it such as escape, avoidance behaviors and ruminant thoughts. It is a brief treatment consisting of 10 to 12 sessions spaced weekly (one hour per session), the first sessions are an explanation of the treatment and depression. Subsequent sessions are based on a collaborative work where the therapist and the patient work together to find activities that are according to the needs of the patient.
15846736|NCT04069169|Drug|Lidocaine|Intervention group (A) will receive P-IVLT in addition to the standard multimodal analgesia. P-IVLT will consist of 1 mg/kg bolus at start of anesthesia (T0), followed by 2 mg·kg-1·hr-1 infusion for 8 hours (T1), then continued at 1 mg·kg-1·hr-1 infusion thereafter and postoperatively until T0 + 48 hours (T2).
15846737|NCT04069169|Drug|Saline Solution|Control group (B) will receive a placebo (0.9% sodium chloride also known as normal saline), made to mimic the intervention protocol described above, in addition to the standard multimodal analgesia.
15846738|NCT04069156|Device|LVAD Implant|Subjects will undergo Heartmate 3 LVAD implant prior to randomization
15846739|NCT04069156|Drug|Aspirin 100mg|Subjects will be randomized to either Placebo or Aspirin post implant.
15846740|NCT04069156|Drug|Placebo oral tablet|Subjects will be randomized to either Placebo or Aspirin post implant
15846741|NCT04069143|Diagnostic Test|18F-BMS-986327|Imaging Agent
15846742|NCT04069130|Drug|400 mg of BIA 5-1058|1 x 400 mg capsule Oral, Fasted
15846743|NCT04069117|Drug|letrozole 2.5mg (Femara; Novartis Pharma Services, Basel, Switzerland)|letrozole /antagonist protocol
15846748|NCT04069091|Behavioral|'Enjoy your Bump' online self-help intervention|"The intervention employs elements of cognitive behavioral therapy: empathic, clear and sensitive communication with women and their families, problem self-formulation of solutions to problems, behavioral activation, identification and changing negative automated negative thoughts, addressing low confidence, and promoting problem- solving and relapse prevention.
~The Enjoy your Bump intervention will be adapted to the Finnish culture and healthcare setting."
15846749|NCT04069078|Drug|Hyoscine Butylbromide 20 Mg/mL Solution for Injection Ampoule|Patients will receive IV study solution which is hyoscine butylbromide 20 mg in 1 ml one minute after spinal anaesthesia
15846750|NCT04069078|Other|Normal saline|Patients will receive 1 ml of IV normal saline as a placebo one minute after spinal anesthesia
15846751|NCT04069065|Drug|Conversion to Once-daily Tacrolimus|"Orally, once-daily in the morning
~The first dose is converted to approximately 100% of the existing daily dose, taking into account the subject's blood concentration, after which the investigator check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 3~10ng/ml."
15846752|NCT04069052|Drug|Nitric Oxide|Gaseous pulmonary vasodilator, SoKinox (nitric oxide) flowed into a mask and breathed in.
15846753|NCT04069052|Drug|Placebo|Room air (placebo) flowed into a mask and breathed in.
15846754|NCT04069026|Drug|BAY2416964|Oral application of study drug daily in a predefined dose escalation scheme.
15846755|NCT04069026|Drug|BAY2416964|Oral application of study drug daily at the dose defined in the dose escalation scheme to determine the recommended phase 2 dose (RP2D).
15846756|NCT04069013|Procedure|PCNL|Patients receive standard of care treatment for their urolithiasis using one of two surgical procedures, either standard PCNL or Mini-PCNL
15846789|NCT04068766|Drug|Normal saline|The paracervical injection with 10 mL of normal saline was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.
15846790|NCT04068753|Drug|Niraparib|Niraparib: 200 mg, oral, once daily, days 1-21
15846791|NCT04068753|Drug|dostarlimab|dostarlimab: 500 mg IV, every three weeks for 4 cycles followed by 1000 mg every six weeks for up to two years
15846883|NCT04067856|Drug|Bevacizumab Injection|Intravitreal injection
15846757|NCT04069000|Behavioral|Mindfulness-based social-emotional learning program|Grade 3 teachers implement MindUP in their classrooms over the academic year. MindUP is a manualized program informed by cognitive-developmental neuroscience, contemplative science, positive psychology, and social-emotional learning. The curriculum consists of 15 sequential lessons taught in 10-15 minute chunks and cross-curricular extension activities. There are four lesson units: Getting Focused (introduction to brain structure and function, the core practice, and how focused awareness affects brains and feelings), Sharpening Your Senses (focus on internal experiences such as mindful smelling and tasting), It's All About Attitude (focus on cognitive experiences such as positive mindset, perspective-taking, and practicing gratitude), and Taking Action Mindfully (performing acts of kindness to others and building positive relationships). An essential component is the core practice, a focused breathing exercise and mindfulness practice that is implemented three times daily.
15846758|NCT04069000|Behavioral|Regular grade 3 program|Grade 3 teachers are expected to implement activities to achieve a number of pre-specified social-emotional learning outcomes that are identified by the Ministry of Education. Educators have leeway over how they achieve these curriculum expectations and they will report on a weekly basis regarding their implementation of social-emotional learning activities.
15846759|NCT04068987|Diagnostic Test|MRI parametric mapping|Magnetic resonance (MR) sequences (T1 mapping, T2 mapping, T2* mapping, ECV mapping) to determine the MR signal characteristics of the body
15846760|NCT04068974|Drug|Camrelizumab (SHR-1210)|Anticancer T-cell activity is regulated by multiple suppressive mechanisms, including tumour-expressed programmed cell death ligand 1 (PD-L1) signalling to the T-cell inhibitory receptor (programmed death protein 1 [PD-1]). Monoclonal antibodies like SHR-1210 that can block this pathway.
15846761|NCT04068974|Drug|Apatinib|Apatinib is an oral small-molecule tyrosine kinase inhibitor that selectively binds to and inhibits VEGF receptor 2.
15846762|NCT04068961|Other|Genetic analyzes|Analysis by CGH array, homozygotic cartography and candidate gene sequencing
15846763|NCT04068948|Drug|Meperidine|This intervention assesses a child's behavioral outcome for dental procedural sedation in combination with midazolam and hydroxyzine. Children participating in the study will randomly be assigned to receive either a drug regimen of midazolam+hydroxyzine, or midazolam+hydroxyzine+meperidine.
15846764|NCT04068948|Drug|Hydroxyzine|This intervention is given to children for a sedative effect. Children participating in the study will randomly be assigned to receive either a drug regimen of midazolam+hydroxyzine, or midazolam+hydroxyzine+meperidine.
15846765|NCT04068948|Drug|Midazolam|This intervention is given to children for a sedative effect. Children participating in the study will randomly be assigned to receive either a drug regimen of midazolam+hydroxyzine, or midazolam+hydroxyzine+meperidine.
15846766|NCT04068935|Procedure|fracture immobilization after reduction of displaced finger fractures|After closed reduction of a displaced finger fracture, fracture immobilization with either Buddy taping or Splint immobilization
15846767|NCT04068922|Behavioral|Resilience Intervention|Resilience skills training including: pleasant activities, hope/goal-setting, pain acceptance, positive events/reappraisals, and self-efficacy.
15846768|NCT04068896|Biological|NGM120|NGM120 Dose 1
15846769|NCT04068896|Biological|NGM120|NGM120 Dose 2
15846770|NCT04068896|Biological|NGM120|NGM120 Dose 3
15846771|NCT04068896|Biological|NGM120|NGM120 Dose 4
15846772|NCT04068896|Biological|NGM120|NGM120 Dose 5
15846773|NCT04068896|Biological|NGM120|NGM120 Dose 6
15846774|NCT04068896|Other|Placebo|Placebo
15846775|NCT04068883|Other|Q collar|An externally-worn medical device that applies mild jugular compression
15846776|NCT04068870|Behavioral|Contraceptive management program|The contraceptive management program will consist of two components: (1) the World Health Organization's contraception protocol and (2) incentivized visits.
15846777|NCT04068857|Device|rTMS|Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique that received FDA clearance for use in treatment resistant major depressive disorder in 2008 and has become commonly used in clinical practice. rTMS utilizes the application of a repetitively pulsed magnetic field over the scalp to induce an electric field within a discrete area of the cerebral cortex. This electric field results in altered ion flow across the neuronal cellular membrane and ultimately changes in neuronal polarization. rTMS enables investigators to manipulate brain activity in a targeted cortical region as well as downstream connectivity within an associated neuronal circuit. High frequency (HF) rTMS leads to facilitatory effects on brain excitability. Previous studies have demonstrated that administration of as little as a single train or a small number of trains are able to produce an immediate increase in cortical excitability.
15846778|NCT04068844|Behavioral|Exercise training|Exercise training, either whole body or isolated single leg
15846779|NCT04068831|Drug|Talazoparib|1 mg talazoparib daily
15846780|NCT04068831|Drug|Avelumab|800 mg avelumab every 2 weeks
15846781|NCT04068805|Behavioral|Happify|An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction.
15846782|NCT04068792|Other|RSV Mobile Application|Participants will not receive any intervention in observational phase of this study. Participant's respiratory symptoms will be captured by RSV mobile application installed in participant's caregiver/parent mobile phone.
15846783|NCT04068792|Drug|Placebo|Participants in each Age Group (1,2,3) will receive matching placebo (volume placebo to match the calculated volume of the JNJ-53718678 dose) orally twice daily for 7 days.
15846784|NCT04068792|Drug|JNJ-53718678 2.5 mg/kg|JNJ-53718678 will be administered to Age Group 1 twice daily for 7 days.
15846785|NCT04068792|Drug|JNJ-53718678 3 mg/kg|JNJ-53718678 will be administered to Age Group 2 twice daily for 7 days.
15846786|NCT04068792|Drug|JNJ-53718678 4.5 mg/kg|JNJ-53718678 will be administered to Age Group 3 twice daily for 7 days.
15846787|NCT04068766|Device|Paracervical block|The paracervical injection with 10 mL of 0.5% bupivacaine plus 1:200,000 epinephrine or normal saline was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.
15846788|NCT04068766|Drug|5% bupivacaine|The paracervical injection with 10 mL of 0.5% bupivacaine plus 1:200,000 epinephrine was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.
15846794|NCT04068727|Behavioral|Clinical Pharmacist Intervention|The Intervention Clinical Pharmacist(s) will provide the components of the intervention to all intervention study subjects, including: conducting initial consultations, providing patient education, conducting follow-up phone consultation, fielding safety net access line inquiries, and corresponding with the patient's clinical care team.
15846795|NCT04068714|Procedure|Type of aneurysm repair|In open surgery repair group, aneurysm repair was performed by open surgery including aortobifemoral bypass, aorto-bi-iliac bypass and tubular aortic bypass. In endovascular repair (EVAR group), aneurysm correction was performed by percutaneous approach, femoral cutdowns and aorto-uni-iliac EVARs with femorofemoral bypass.
15846796|NCT04068701|Other|MaNMT Biofeedback|neuromuscular training intervention that incorporates biofeedback training
15846797|NCT04068688|Behavioral|Early Start Denver Model (ESDM)|"Twelve one hour sessions, skill is introduced by Help is in your hands Community ESDM videos. Session skills include specific strategies caregivers can use to increase their child's attention to people and their child's communication; strategies to identify, create and use joint activity routines to engage with and teach their child; in addition to ways to use the ABCs of learning to teach their child new behaviors. Help is in your hands Community ESDM materials also provide video examples of other caregivers using the session skill with their child. The early childhood development practitioner then coaches the caregiver in the session skill, in at least two activities. The goal of coaching was to provide enough support for the caregiver to experience success in implementing the new skill with their child. Coaching is followed by caregiver reflection and a discussion of generalization of the new skill across various daily activities, using a daily activities visual aid."
15846798|NCT04068675|Behavioral|Group pre-operative counseling|Enrolled patients will participate in a group pre-operative counseling session on the online conferencing platform BlueJeans® prior to their surgery. The sessions will not replace any portion of the pre-operative standard counseling and is designed to review and re-enforce the counseling already provided. The sessions will not review or discuss the specifics of any one individual's cancer or surgery. Rather the counseling session will focus on the universal instructions provided to all patients undergoing major surgery for a known or suspected gynecologic malignancy. The sessions will be led by a physician on a weekly basis with a minimal of three (3) enrolled patients per session and last approximately one (1) hour.
15846799|NCT04068662|Behavioral|Pregnant Moms' Empowerment Program|The Pregnant Moms' Empowerment Program is a five session group therapy program designed for pregnant women with a recent history of exposure to intimate partner violence. One session is administered each week with a duration of 2 hours each, for a total of ten contact hours across the course of the intervention. Intervention topics includes safety planning, social support, resilience, psychoeducation about intimate partner violence, cognitive and behavioral strategies for remediating distress, infant sleep and breastfeeding, responsive parenting, and co-parenting.
15846800|NCT04068662|Behavioral|Nondirective Support Group|Participants in the non-directive support group condition participate in groups of the same size and with the same total contact time as women in Intervention 1. In contrast to the structured, manualized content delivered as a part of the Pregnant Moms' Empowerment Program, however, group leaders in this condition facilitate open conversation on topics that women identify together as a group.
15846801|NCT04068649|Radiation|Palliative Radiation Therapy|Undergo palliative RT
15846802|NCT04068649|Other|Quality-of-Life Assessment|Ancillary studies
15846803|NCT04068649|Other|Questionnaire Administration|Ancillary studies
15846804|NCT04068649|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15846805|NCT04068636|Procedure|Radioactive tracer injection via flexible endoscopy and SPECT scan for visualization of lymph nodes.|Flexible endoscopy will be performed by one of two experienced head and neck surgeons. Inspection of larynx and pharynx will be performed to determine the extensions of the tumor in all directions. After local anesthesia, 2-4 peritumoral injections of Tc-99m-nanocolloïd will be given. Ten minutes after injection of Tc-99m-nanocolloïd a SPECT scan will be performed.
15846806|NCT04068623|Other|Blood sample|Blood samples will be collected at 12 months after radiation therapy and at the time of first metastatic recurrence
15846807|NCT04068610|Drug|Standard of Care|"Parts of FOLFOX are: Oxaliplatin 85 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Folinic acid (leucovorin) 400 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Fluorouracil (5-FU) 2400 mg/m2 administered by continuous IV infusion over 46 to 48 hours Q2W (Day 1-2 of every 14-day cycle). Note: 5-FU will be administered as infusion only.
~Bevacizumab 5 mg/kg IV infusion Q2W (Day 1 of every 14-day cycle)"
15846808|NCT04068610|Drug|Experimental|Parts of FOLFOX are: Oxaliplatin 85 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Folinic acid (leucovorin) 400 mg/m2 IV infusion Q2W (Day 1 of every 14-day cycle), Fluorouracil (5-FU) 2400 mg/m2 administered by continuous IV infusion over 46 to 48 hours Q2W (Day 1-2 of every 14-day cycle). Note: 5-FU will be administered as infusion only. Bevacizumab 5 mg/kg IV infusion Q2W (Day 1 of every 14-day cycle) Durvalumab 1500 mg IV Q4W Oleclumab 3000mg IV Q2W x 4 then Q4W
15846809|NCT04068597|Drug|CCS1477|Oral
15846810|NCT04068584|Other|Smart Angel|Patient issued with a tablet with the Smart Angel application to monitor clinical signs and symptoms
15846811|NCT04068571|Behavioral|I-PUSH|Innovative partnership for universal and sustainable healthcare
15846812|NCT04068558|Device|VNI-NAVA/sNIPPV|Ventilation of the child in NIV-NAVA for 2 hours then ventilation of the child in sNIPPV for two hours. The ventilation periods consist of one hour of wash-out and one hour of data collection
15846813|NCT04068558|Device|sNIPPV/VNI-NAVA|Ventilation of the child in sNIPPV for 2 hours then ventilation of the child in NIV-NAVA for two hours. The ventilation periods consist of one hour of wash-out and one hour of data collection
15846814|NCT04068545|Device|Device: Thoraguard Surgical Drainage System|Fluid drainage following thoracic surgery
15846815|NCT04068532|Drug|Placebo|Administered as specified in the treatment arm.
15846816|NCT04068532|Drug|BIIB104|Administered as specified in the treatment arm.
15846817|NCT04068519|Drug|Tislelizumab|200 milligrams intravenously on Day 1 during each 21-day cycle
15846818|NCT04068506|Drug|Gabapentin 600 mg Tab|Gabapentin 600 mg Tab is a drug of choice for treating postoperative pain.
15846819|NCT04068493|Behavioral|Enhanced Project Health|A dissonance-based obesity intervention consisting of eight weekly groups sessions (1.5 hours).
15846820|NCT04068467|Other|Smartphone App|The application consists of content areas focused on mental health.
15846821|NCT04068467|Other|Waitlist Control|Waitlist control
15846822|NCT04068454|Device|Virtual reality device|Functional exercises will be done by virtual reality group
15846823|NCT04068454|Other|EBM rehabilitation exercises|scapular exercises will be done
15846824|NCT04068441|Other|no intervention|No intervention
15846825|NCT04068415|Other|Constipation risk assessment scale|questionnaires
15846826|NCT04068402|Device|Vivio System|The Vivio System is an electronic auscultatory device and optical sensor, plus software application intended to provide support to the physician in the evaluation of heart sounds in patients. The product will analyze the acoustic signals of the heart and signals from a captured arterial (carotid) waveform. The analysis procedure will identify and analyze specific heart sounds and arterial waveform features captured by the Vivio device, to devise a scoring system for severe aortic stenosis.
15846827|NCT04068389|Procedure|Pulmonary Tissue Collection|Pulmonary Tissue Collection
15846828|NCT04068376|Other|Control excercise|Each session will be for 60 minutes, 3 days a week, for 24 weeks. The make-up of each session is 1) 5 minutes of warm-up; 2) 30 minutes of moderate-to-strong intensity aerobic exercise, 3) 5 minutes of aerobic cool-down, 4) 20 minutes of balance-stretching exercise; and 5) 5 minutes of cool-down stretching (this times does not count as activity).
15846829|NCT04068376|Other|"Mind and Movement for Cognitive Health in the Older Adult"|The T1-GR will consist of 60-minute training sessions delivered three days a week during a 24-week period. Each session will be guided by a health profesional certified to coach SSE. The make-up of each session is: 1) 5 minutes of warm-up; 2) 30 minutes of moderate-to-strong intensity aerobic exercise, 3) 5 minutes of aerobic cool-down, 4) 20 minutes of double-task exercise (mat); and 5) 5 minutes of cool-down stretching (this times does not count as activity).
15846830|NCT04068376|Other|Double-task exercise by older adults and their caregivers|"In the case of T2-GR, older adults and their caregivers will participate in the same SSE program led by a coach for 12 weeks; older adults will then be asked to continue SSE at home under the supervision and with the active participation of their caregivers for another 12 weeks. They will be asked to practice SSE for 60 minutes, three times a week, and to reach a ≥65% heart rate increase. In the field of sports, the people who perform the above-mentioned activities are called pacers, and they supervise physical activity through active accompaniment of older adults."
15846831|NCT04068363|Other|non interventional|non interventional study
15846832|NCT04068350|Other|Pain questionnaire|Pain questionnaire, 3 months after surgery
15846833|NCT04068337|Procedure|Aortic root replacement with Freestyle biological prosthesis with and without hemiarch replacement|Aortic root replacement with Freestyle biological prosthesis. Some patients receive additional hemiarch replacement performing an open anastomosis to the aortic arch under antegrade cerebral perfusion through axillary artery. Comparison with patients, who were cannulated and perfused systemically
15846834|NCT04068324|Dietary Supplement|New Care No Nil Per Os|"The product name NoNPO is from South Korean company Well life. It contains carbohydrate and is frequently used in preoperative fasting patients in order to alleviate patients' discomfort resulting from empty stomach and thirst. It is also known to decrease insulin resistant."
15846835|NCT04068311|Other|Geriatric Screening tools|Lean Six Sigma implementation in the Emergency Department of nurse-driven geriatric screening tools and protocols for patients with fall risk, delirium, and high risk scores.
15846836|NCT04068285|Other|Aerobic Exercise|Participants will be making aerobic exercise
15846837|NCT04068272|Drug|Bosentan|Eyedrop
15846838|NCT04068272|Drug|Placebo|Ophthalmic eyedrop with the exact same excipient of the drug arm without the active compound
15846839|NCT04068259|Drug|PBI-4547|PBI-4547 tablet
15846840|NCT04068259|Other|Placebo|Placebo tablet
15846841|NCT04068246|Drug|Metformin|1000 mg of Metformin table taken orally daily plus Methotrexate 7.5 mg weekly
15846842|NCT04068246|Drug|Placebo|Placebo tablet plus plus Methotrexate 7.5 mg weekly
15846843|NCT04068233|Other|Pacemaker stimulation mode|Echocardiographic indices are measured during AV asynchronous and AV synchronous pacemaker stimulation.
15846844|NCT04068220|Other|intraoperative FVEPs monitoring|During the surgery, a pair of goggles (similar to the swimming goggles) will be placed on patient's closed eyes. The goggles equipped with red LEDs will apply no pressure or minimal pressure on patient's closed eyes. Patient's left eye then right eye will be stimulated with flashing red light emitted by the goggles. Two subdermal needle electrodes will be placed under the skin behind patient's ears, and one subdermal needle electrode will be placed under the skin above the bridge of patient's nose. The two electrodes placed behind patient's ears, will record intraoperative flash visual evoked potentials (FVEPs) resulted from red light stimulation of patient's visual pathway through the eyes and the electrode above the bridge of the nose will record, at the same time, the activity of each eye's retina.
15846845|NCT04068207|Drug|Minocycline|Tab. Minocycline 100mg po per day for 24 weeks
15846846|NCT04068194|Drug|Avelumab|Given IV
15846847|NCT04068194|Radiation|Hypofractionated Radiation Therapy|Undergo hypofractionated RT
15846848|NCT04068194|Drug|Peposertib|Given PO
15846849|NCT04068181|Drug|Talimogene laherparepvec|"On day 1 the first dose of talimogene laherparepvec will be up to 4.0 mL of 10^6 PFU/mL by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions with or without image ultrasound guidance. The second dose of up to 4.0 mL of 10^8 PFU/mL talimogene laherparepvec will be administered 21 days after the initial dose.
~Subsequent doses of up to 4.0 mL of 10^8 PFU/mL talimogene laherparepvec will be given every 3 weeks."
15846850|NCT04068181|Drug|Pembrolizumab|Pembrolizumab will be administered intravenously at a fixed dose of 200 mg every 3 weeks.
15846851|NCT04068155|Device|DaRT- Diffusing Alpha-emitters Radiation Therapy|Seed(s) loaded with Radium-224 for local intratumoral irradiation with the destructive power of alpha particles
15846884|NCT04067843|Procedure|Photodynamic treatment|Photosensitiser application, followed by fluorescence photography Photodynamic therapy (PHT) (1x) over 15 minutes
15846885|NCT04067830|Other|Best Practice|Receive usual care
15846886|NCT04067830|Procedure|Laparoscopic Surgery|Undergo laparoscopic surgery
15846887|NCT04067830|Other|Quality-of-Life Assessment|Ancillary studies
15846888|NCT04067830|Other|Questionnaire Administration|Ancillary studies
15846889|NCT04067830|Device|Respiratory Muscle Training Device|Use power lung device to complete RMT
15846890|NCT04067830|Procedure|Video-Assisted Thoracic Surgery|Undergo video-assisted thoracic surgery
15846852|NCT04068142|Other|Peer Supporter Safety Planning|The rationale for testing a peer-delivered intervention in the ED relies on the following evidence: a) a peer is an individual with lived experience who is now supporting other mental health patients in crisis; b) the experience of a mental health patient in the ED often shapes the perception of the health system, and may influence willingness to seek future care; c) peers may provide more empathetic care than providers without lived experience, which may positively impact patients; d) peer-based programs for patients with serious mental illness that do not involve safety planning are at least as good as non-peer based programs at preventing hospitalizations and promoting engagement in care, with the most promising interventions involving self-management or peer-navigator roles; and e) existing evidence from high-quality studies is scarce, but in moderate-low quality studies has indicated that peers are no less effective than mental health workers
15846853|NCT04068129|Device|photoscreen|Determine amblyopia risk factors
15846854|NCT04068116|Procedure|Primary per-cutaneous coronary intervention|Patients presenting with ST-elevation myocardial infarction will undergo primary per-cutaneous coronary intervention including balloon angioplasty & coronary stent deployment as needed +/- post-conditioning (for post-conditioning arm) making 4 cycles of repeated occlusion & reperfusion 30-second each by inflation/deflation of an appropriately sized PTCA (percutaneous transluminal coronary angioplasty) balloon
15846855|NCT04068103|Drug|Capecitabine|Given PO
15846856|NCT04068103|Drug|Fluorouracil|Given IV
15846857|NCT04068103|Drug|Leucovorin|Given IV
15846858|NCT04068103|Drug|Leucovorin Calcium|Given IV
15846859|NCT04068103|Drug|Oxaliplatin|Give IV
15846860|NCT04068103|Other|Patient Observation|Undergo active surveillance
15846861|NCT04068090|Other|Patient Questionnaires|FACT-Ntx, EORTC-CIPN20
15846862|NCT04068090|Other|Blood Collection|biomarker analysis
15846863|NCT04068077|Device|ApolloVue™ S100 image system, Viper1-S003|The device is an in vivo non-invasive optical coherence tomography and will be used to obtain at least 6 medical images of normal and lesional skin, respectively, for experimental group.
15846864|NCT04068064|Procedure|EABM training|"The training aims at associating gaming pictures with negative words and pictures of healthy activities with positive words. Gaming pictures are always presented with a pair of negative words. Pictures of healthy activities are always presented with a pair of positive words. Each picture is presented with a fixed pair of words. Participants will be instructed to select one word to get the most monetary reward. Specifically, in response to each gaming picture, selecting one word will have a 70% chance to get a monetary reward and the other word will have a 30% chance to get a monetary reward. A similar rationale applies to the pictures of healthy activities. The reward setting will help consolidate target associations.
~Each training session includes 300 times/trials of each type of association, presented in pseudorandom way. The whole training includes 6 training sessions. Participants will receive one training session every days."
15846865|NCT04068064|Procedure|sham training|In the control group, neutral words instead of emotional words are used. All other settings are the same with those in the intervention group
15846866|NCT04068051|Drug|AXS-07|AXS-07 (MoSEIC meloxicam and rizatriptan) taken by mouth for the acute treatment of migraine.
15846867|NCT04068025|Other|Assigned Interventions|"Information: In the information step of the bladder training program given through the IMB model, training was given about pelvic floor muscle exercises, bladder program formation, and lifestyle change. The training was conducted face-to-face by the nurse researcher for about 15-20 min, and the training booklet was given to the patients.
~Motivation: The patients in the intervention group were interviewed by the nurse researcher by phone or face-to-face in the 1st, 3rd, and 6th months after the training. The patients were motivated by providing information and counseling on the necessary issues. This process was carried out using motivational interviewing principles. Patients were given positive behavioral feedback and encouraged to control urinary incontinence.
~Behavioral Skills: Behavioral skills related to urinary incontinence were evaluated 6 months after the training,together with their effects on urinary incontinence symptom score and quality of life."
15846868|NCT04068012|Other|Ventilator protocol|open loop ventilator management by a computer based protocol
15846869|NCT04067999|Drug|Semaglutide|Patients will be treated with commercially available semaglutide in a prefilled pen injector (FlexTouch® variant) according to routine local clinical practice at the discretion of the treating physician. Other anti-hyperglycaemic treatments will be prescribed at the physician's discretion.The decision to initiate treatment with semaglutide is at the treating physician's discretion, and clearly separated from the decision to include the patient in the study.
15846870|NCT04067986|Drug|Camrelizumab|"Camrelizumab One course will last 28 days.Intravenous injection at a dose of 200 mg, q2w
~One course will last 28 days. Oral administration at a dose of 250 mg/d"
15846871|NCT04067986|Drug|Apatinib|Apatinib One course will last 28 days.Oral administration at a dose of 250 mg, qd
15846872|NCT04067960|Procedure|Biospecimen Collection|Undergo collection of saliva
15846873|NCT04067960|Other|Genetic Testing|Undergo pharmacogenomics testing
15846874|NCT04067960|Other|Quality-of-Life Assessment|Ancillary studies
15846875|NCT04067960|Other|Questionnaire Administration|Ancillary studies
15846876|NCT04067947|Drug|XG005|XG005 Tablet
15846877|NCT04067947|Drug|Placebos|Placebo Tablet
15846878|NCT04067934|Behavioral|Jumping Exercise programme|Four weeks of three jumping-based exercise sessions per week. These sessions will involve basic jumping movements, with approximately 50-100 jumps per session; incorporating 20-30 minutes of exercise.
15846879|NCT04067908|Other|2 tubes of 5ml during the blood collection and 2 swabs during vaginal sampling|The samples taken during this study are taken at the same time as those taken in routine during the diagnosis of threat of premature labor. There are added 2 tubes of 5ml during the blood collection and 2 swabs during vaginal sampling.
15846880|NCT04067895|Procedure|epiphysiodesis|All patients undergo surgical treatment of leg lengths discrepancies or primordial gigantism. Human bone graft screws will be used to stop the distraction of the growth plate.
15846881|NCT04067882|Other|Genetic signature|The RNA will be extracted from the tumor sample with a special kit and a q-PCR will be performed. In order to quantify the genetic expression, the comparative method called Cycle threshold or Crossing point will be used.
15846882|NCT04067869|Procedure|Blood samples|Blood sample containing 3 ethylene-diamine-tetra-acetic acid tubes (7ml), 3 dry tubes (7ml) and 5 citrated tubes, ie 9 tubes
15846891|NCT04067817|Drug|norepinephrine|patient who was received the treatment of norepinephrine
15846892|NCT04067817|Drug|Phenylephrine|patient who was received the treatment of phenylephrine
15846893|NCT04067804|Behavioral|Dynamic Adaptation Process|The Dynamic Adaptation Process draws from implementation science frameworks and methods, including the Exploration, Preparation, Implementation, and Sustainment model, to organize planning and implementation activities. The Dynamic Adaptation Process is a structured methodology designed to integrate new interventions within complex systems, such as schools.
15846894|NCT04067791|Dietary Supplement|Prolonged-Release Melatonin|4.47 mg melatonin in a bi-layer prolonged-release capsule
15846895|NCT04067791|Dietary Supplement|Immediate-Release Melatonin|4.47 mg melatonin in a standard release bi-layer capsule
15846896|NCT04067778|Diagnostic Test|Intervention Group|Standard colonoscopy with targeted biopsies only
15846897|NCT04067778|Diagnostic Test|Control Group|Standard colonoscopy with random AND targeted biopsies
15846898|NCT04067765|Behavioral|Alcohol cue|Participants will undergo a validated in-scanner alcohol cue exposure protocol involving passive viewing of images of alcohol beverages (beer, wine, liquor)
15846899|NCT04067765|Behavioral|Neutral cue|Participants will undergo a validated in-scanner alcohol cue exposure protocol involving passive viewing of images of neutral beverages (water, soft drinks, juice).
15846900|NCT04067752|Other|high dialysate sodium concentration (138 mEq/L)|high dialysate sodium concentration (138 mEq/L)
15846901|NCT04067752|Other|Low dialysate sodium concentration|low dialysate sodium concentration (132 mEq/L)
15846902|NCT04067739|Other|non interventional study|non interventional study
15846903|NCT04067726|Drug|Denosumab|Denosumab is commercially available and will be provided at no cost to participants.
15846904|NCT04067726|Drug|Placebo|Placebo will be made available as 1 mL sterile, non-pyrogenic water solution in a single-use prefilled syringe.
15846905|NCT04067726|Drug|Calcium|-Participants will be instructed to take calcium (600 mg) daily for 12 months between baseline examination and 12- month mammographic breast density examination.
15846906|NCT04067726|Drug|Vitamin D3|Participants will be instructed to take vitamin D3 (800 IU) supplements daily for 12 months between baseline examination and 12- month mammographic breast density examination.
15846907|NCT04067726|Procedure|Core needle biopsy|Baseline and 12 months
15846908|NCT04067726|Procedure|Blood draw|Baseline and 12 months
15846909|NCT04067700|Procedure|Invasive coronary treatment|Coronary artery bypass surgery or percutaneous coronary intervention.
15846910|NCT04067687|Other|Palliative home visit|a 3-month home visit, providing two-way communication between a trained health worker and patients with or without their parents were conducted as the intervention (report by proxy or self-report). Interventions were given in 6 sessions (1 session every 2 weeks) focusing on problems solving education, symptoms management, self-care, communication, decision making, and long-term care plan assistance.
15846911|NCT04067674|Biological|Blood sampling|Blood sampling for biomarker measurement
15846912|NCT04067661|Behavioral|CHIP|The couples-based HIV prevention intervention consists of four couples counseling sessions focused on relationship skills to decrease HIV risk behaviors.
15846913|NCT04067661|Behavioral|Control|Enhanced standard of care, which includes information and referrals on HIV risk and prevention.
15846914|NCT04067648|Drug|Sufentanil Injection|three doses of sufentanil was intravenously given during anesthesia induction
15846915|NCT04067622|Device|Exersides|A novel arm restraint which permits arm mobility but prohibits hands from reaching oral/nasal endotracheal and feeding tubes or intravenous lines.
15846916|NCT04067609|Drug|Dexamethasone|subjects will receive a single administration of either 0.1 mg/kg of intravenous dexamethasone in 90mL of normal saline
15846917|NCT04067609|Other|placebo|100mL of normal saline (placebo)
15846918|NCT04067596|Procedure|epiphysiodesis|"The procedure consists of sterilizing the growth cartilage of the various localizations (distal femur and proximal tibia).
~Under general anesthesia under scopic control, the growth cartilage will be approached from both sides in order to curse the growth zone.
~This procedure is monitored throughout the procedure with iterative X-rays, to ensure complete curettage of the growth cartilage. The average duration of the intervention is 1 hour and a half.
~At the end of the procedure, there will be on each limb, 2 operative scars on each side of the knee, 8 scars in all.
~Closing will be done with resorbable stitches A simple dressing will be applied to each scar and a Zimmer splint in extension will be installed postoperatively to limit the painful mobilizations in acute phase."
15846919|NCT04067583|Other|Physician questionnaire|This is a one-time cross-sectional survey of physicians, conducted electronically; there are no in person visits
15846920|NCT04067570|Radiation|SBRT|Stereotactic body radiation therapy, or SBRT, is a cancer treatment that delivers extremely precise, very intense doses of radiation to cancer cells while minimizing damage to healthy tissue
15846921|NCT04067557|Diagnostic Test|molecuar test of BV|diagnosis of BV
15846922|NCT04067544|Device|Acupuncture|"The manualized acupuncture treatment (AT) intervention will be designed by Dr. Budhathoki and Dr. Taylor-Swanson and administered by Dr. Budhathoki and members of Huntsman acupuncture team. Ten sessions of AT will be delivered: twice per week for 2 weeks, thereafter once per week for six weeks, with a total of 9 treatments during a two-month course. Each session will last 45-60 minutes, with acupuncture needles retained 30-40 minutes. A minimum of 8 treatments must be received by each participant with no more than 9 days' gap between treatments permitted. Concurrent medications are allowed as prescribed and will be tracked in the study and analyzed as potential confounders.
~Participants in the study will undergo study interview and fMRI at the following two time points: within 9 days after baseline following enrollment and within one week of acupuncture treatment completion."
15846923|NCT04067531|Drug|treatment of BV with first Deqularum and then direkt after with vaginal clindamycin|All patients will get the same treatment
15846924|NCT04067518|Biological|Pegaspargase|Pegaspargase : powder for solution for injection, IV (administered by 1 to 2 hours of drip infusion), dose determination : if BSA ≥0.6 m2: 2500 IU/m2 every 14 days if BSA <0.6 m2: 82.5 IU/kg every 14 days
15846925|NCT04067505|Drug|Rivaroxaban|Dose: 15mg twice daily for three weeks, then 20mg once daily until six months after the operation. Application: oral
15846926|NCT04067505|Drug|Warfarin|Dose: 3mg for 5 days after the operation, later 0.75mg to 18mg depending on INR (2.0-3.0) until 6 months Duration: 6 months Frequency: once daily Application: oral
15846927|NCT04067505|Drug|Nadroparin|Dose: 1mg/kg Duration: 5 days after the operation Frequency: twice daily Application: subcutaneous
15846928|NCT04067492|Drug|RPH - 104|solution for subcutaneous administration 40 mg/mL, 2 mL in the 4-mL glass vial
15846929|NCT04067492|Drug|Voltaren®|Enteric-coated tablets, 25 mg and 50 mg
15846930|NCT04067479|Dietary Supplement|Amino Acids|Oral bolus of essential amino acids
15846931|NCT04067466|Dietary Supplement|Fiber product|Fiber product with inulin, maltodextrin, gum guar and plum powder.
15846932|NCT04067466|Dietary Supplement|Control product|Placebo product with maltodextrin and plum powder
15846933|NCT04067453|Other|Fatiguing contractions|10 sustained external anal sphincter contractions with maximal voluntary contraction of 20 seconds followed by 10 seconds of resting.
15846934|NCT04067440|Diagnostic Test|Microbial Swab|Swabs will be taken from peritoneum and jejunum (intraoperatively), rectum, and stool
15846935|NCT04067427|Other|Mental training|App-based mental training
15846936|NCT04067414|Biological|BZ019|"Subjects will be enrolled in three dose-groups:
~Dose 1: 1×10^6/kg CAR+ cells; Dose 2: 3×10^6/kg CAR+ cells; Dose 3: 6×10^6/kg CAR+ cells."
15846937|NCT04067401|Behavioral|Wingman Connect|Wingman-Connect combines group and individual skill training. Group exercises build cohesion, belonging and shared purpose, and promote value of healthy unit, giving and receiving support. Individual skills promote the ability to thrive during transitions, manage stressors and meet career goals, and decrease barriers to utilizing organizational resources (family, health). The training has a total of 22 modules comprised of specific learning objectives and activities. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills.
15846938|NCT04067401|Behavioral|Stress Management|Stress management training reviews the basics of the hypothalamic-pituitary-adrenal axis stress-response system; common experiences of stress (physiological, cognitive, emotional); the impact of chronic stress on the brain and other domains of health; how exercise reduces harmful effects of stress; and relaxation techniques that have been shown to reduce stress and adverse effects of stress on health. Additional modules review the physiological stress response and effects of stress on health; introduces how cognition influences stress responses; common cognitive distortions/attributions are reviewed that affect stress including strategies to strengthen protective cognitive responses. Six months of text messages (1-2 per week) to reinforce and extend program concepts and skills.
15846939|NCT04067388|Other|Rapid Evaporative Ionisation Mass Spectrometry (REIMS)|Use of iKnife instrument during standard operative practice
15846940|NCT04067375|Other|Clinical data collection.|The following clinical data will be collected; maternal baseline characteristics, delivery related data, neonatal outcome, neonatal bleeding signs.
15846941|NCT04067362|Other|food containing dietary fiber|commercially available chicory root flour and chicory root fiber
15846942|NCT04067349|Other|Ergometry|"Patients underwent a preoperative ergometry to assess their physical fitness prior to their planned liver resection.
~Bicycle stress testing was performed preoperatively and 1 and 6 months postoperatively."
15846944|NCT04067323|Dietary Supplement|Soya bean oil|Participants will consume soya bean oil together with yogurt in lunch daily meals and be monitored side effects and diarrhea. Then they will be evaluated anthropometric index, body compositions and blood lipid profile after 2 months (T1) and 4 months (T2) intervention. This product is composed of 12% total energy intake of participants.
15846945|NCT04067323|Dietary Supplement|MCT oil|Participants will consume MCT oil together with yogurt in lunch daily meals and be monitored side effects and diarrhea. Then they will be evaluated anthropometric index, body compositions and blood lipid profile after 2 months (T1) and 4 months (T2) intervention. This product is composed of 12% total energy intake of participants.
15846946|NCT04067310|Other|Spray skin protector|Patients will use spray skin protector treatment from the randomization day until the last day of radiotherapy.
15846947|NCT04067310|Other|moisturizer containing in its composition calendula officinalis|Patients will use conventional preventive treatment from the randomization day until the last day of radiotherapy.
15846948|NCT04067297|Other|Lipid management toolbox|The intervention toolbox will include: 1) community-level report cards on lipid management (developed using an updated version of the 2016 CANHEART 'big data' registry of ~10.9 million adults created through linkage of 19+ population health databases) to distribute to family physicians, 2) printed and electronic patient education materials on cholesterol screening and management, 3) a new online clinical decision aid to facilitate shared decision-making between patients and their family physicians regarding statin utilization, 3) patient educational videos, and 4) physician educational videos and material.
15846949|NCT04067284|Behavioral|Nutrition education|"Nutrition Education on
~Continued breastfeeding until two years of age
~Food groups
~Balanced diet
~Introduction to locally available nutritious and low-cost foods
~Amount and frequency of complementary feeding
~Safe water, and
~Handwashing with soap before feeding"
15846950|NCT04067284|Dietary Supplement|Nutrition education+Homemade yogurt supplementation|"Nutrition Education on
~Continued breastfeeding until two years of age
~Food groups
~Balanced diet
~Introduction to locally available nutritious and low-cost foods
~Amount and frequency of complementary feeding
~Safe water, and
~Handwashing with soap before feeding
~The homemade yogurt supplementation will start a week after beginning of 6 months of age once the child is introduced to solid foods of the mother's choice. The yogurt will be supplied to the mothers every day at time of feeding."
15846951|NCT04067284|Other|Usual care|No intervention/ control group
15846952|NCT04067271|Other|Analyze changes in intestinal microbiome|Descriptive Analysis
15846953|NCT04067258|Diagnostic Test|EDI-OCT|"EDI-OCT (enhanced depth imaging spectral domain optical coherence tomography) wiil be performed in all study participants.
~Three sets of measurements in the macular (horizontal and vertical) and peripapillary area will be averaged."
15846974|NCT04067115|Other|3'-Deoxy-3'-18F Fluorothymidine (18F-FLT) Imaging|Some patients will receive PET scans with the use of 18F-FLT, a radioactive tracer, performed at the National Institute of Health.
15846975|NCT04067102|Drug|Albumin bound (nab)-paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide|Paclitaxel for injection (albumin binding)260mg/m2，I.v., d1；carboplatin AUC=5, I.v., d1； 21 days in one cycle, 4 cycles in total.Continue the protocol when evaluated as CR/PR/SD at the second cycle, Terminate the protocol paclitaxel (albumin binding) combined with carboplatin when evaluated as PD at the second cycle，and use the EC protocol in advance or decide the next treatment
15846954|NCT04067245|Device|Tetrasodium EDTA catheter lock solution|Home parenteral nutrition patients who meets inclusion criteria is to receive tetrasodium edta catheter lock solution. Patient will receive standard catheter lock solution of heparin/saline for 1 month, followed by tetrasodium EDTA catheter lock solution using withdrawal method for 1 month and followed by tetrasodium EDTA catheter lock solution using flush method for 1 month. In total, patient will stay in the study for 3 months. A phone call will be conducted before the start of the study to give instruction to patient regarding the use of catheter lock solution. Time taken to connect and disconnect TPN will be recorded by patients, twice a month on first and last mondays of the month for 3 months. A survey regarding the ease of use of catheter lock solution will be conducted at the end of each month via phone by nurse coodinator.
15846955|NCT04067232|Diagnostic Test|4D-CT-scan|Both forearms of the subjects with posttraumatic forearm impairment are scanned with a 4D-CT scanning technique, during forearm rotation.
15846956|NCT04067219|Procedure|DXA (dual-energy x-ray absorptiometric) measurement|DXA, evaluation of muscular function and muscle strength; neurocognitive tests; non invasive analysis of mechanical skin properties; food frequency questionnaire; laboratory assessment (25 hydroxy vitamin D, calcium/phosphate metabolism, bone remodelling markers, T cell activation).
15846957|NCT04067206|Other|RECORDED MOTHER'S VOICE|The mothers of the babies were given voice recorders and asked to record their voice in a comfortable room saying whatever they wanted to their baby. Each mother recorded her voice for 3-5 minutes. The voice recorder was placed at the baby's foot five minutes before the procedure and then played to the baby during the procedure.The sound level was adjusted to 50 decibels using the Benetech Digital Sound Level Meter for the mother's voice and white noise groups.
15846958|NCT04067206|Other|White Noise|"The white noise was started five minutes before the heel lance and was played to the baby during the procedure. Dr. Harvery Karp's The Happiest Baby, which consists of only intrauterine sounds, was used. The speakers were placed at a distance of about 30 cm from the foot of the neonate. The sound level was adjusted to 50 decibels using the Benetech Digital Sound Level Meter for the mother's voice and white noise groups."
15846959|NCT04067206|Other|MiniMuff|MiniMuffs placed on their ears five minutes before the procedure to reduce the environmental noise. Latus MiniMuffs - Neonatal Noise Attenuators have been developed for newborns and premature babies. MiniMuffs protect the sensitive ears of the premature and provide a safe environment for healthy development.
15846960|NCT04067193|Other|usability survey|usability survey composed of subpart: System Usability Scale, questions about ergonomic, questions about design, question about global satisfaction.
15846961|NCT04067180|Other|allogeneic stem cell transplantation with a haplo-identical family donor graft|"The graft should preferably be bone marrow, but peripheral stem cells are also acceptable.
~Pre-conditioning: thiotepa 5 mg/kg/day for two days (day -6, -5), busulfan at 3,2 mg/kg/day (i.v.) and fludarabine at 50 mg/m2 (i.v.) for three consecutive days (day -4, -3, -2). Intravenous busulfan can be replaced by orally administered busulfan at a dose of 4 mg/kg/day on 3 consecutive days (day -4, -3, -2).
~GVHD prophylaxis: cyclophosphamide 50 mg/kg day +3 and +5, cyclosporin A and mycophenolate mofetil."
15846962|NCT04067180|Other|allogeneic stem cell transplantation with a matched unrelated donor graft|"Patients are treated according to the standard conditioning protocols developed for URD SCT at each participating center, with a recommendation to use Flu+Bu (fludarabine + busulfan, with a total Bu dose of 8-16 mg/kg body weight orally, or 6,4-12,8 mg/kg i.v.) or Bu+Cy (busulfan + cyclophosphamide, with a dose of Cy not exceeding 50 mg/kg x 2).
~The standard GVHD prophylaxis at the center should be applied."
15846963|NCT04067167|Other|WB-EMS (Sham-intervention)|"Whole-Body Electromyostimulation (WB-EMS):
~WB-EMS with low-threshold stimulation during a study period of 12 weeks combined with standard nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted Protein intake/day: 1.2 - 1.5 g per kg bodyweight)
~patients perform simple exercises during the stimulation period following a video tutorial
~time-effort per session: ~20 min
~2 training sessions per week"
15846964|NCT04067167|Other|WB-EMS|"Whole-Body Electromyostimulation (WB-EMS):
~WB-EMS during study period of 12 weeks combined with standard nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted Protein intake/day: 1.2 - 1.5 g per kg bodyweight)
~WB-EMS stimulation protocol: Frequency of 85 Hz, pulse duration of 0.35 ms, stimulation period of 6 sec, resting period of 4 sec;
~patients perform simple exercises during the stimulation period following a video tutorial
~time-effort per session: ~20 min
~2 training sessions per week"
15846965|NCT04067167|Other|Free WB-EMS|"Whole-Body Electromyostimulation (WB-EMS) using a mobile system:
~WB-EMS during study period of 12 weeks combined with standard nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted Protein intake/day: 1.2 - 1.5 g per kg bodyweight)
~WB-EMS stimulation protocol: Frequency of 85 Hz, pulse duration of 0.35 ms, stimulation period of 6 sec, resting period of 4 sec;
~patients perform simple exercises during the stimulation period following a video tutorial
~time-effort per session: ~20 min
~2 training sessions per week"
15846966|NCT04067167|Other|Flexi band resistance training|"Flexi band resistance Training:
~Training during study period of 12 weeks combined with standard nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted Protein intake/day: 1.2 - 1.5 g per kg bodyweight)
~patients perform resistance exercises using flexi bands
~flexi band exercises are conceptualized to activate similar muscle groups as EMS exercise
~time-effort per session: ~20 min
~2 training sessions per week"
15846967|NCT04067154|Diagnostic Test|ALPE|Measurement of CT scan at PEEP of 5, 20 and 45 cm H2O Measurement of gas exchange by model-based method and FiO2 titration at PEEP of 5 and 20 cm H2O
15846968|NCT04067141|Device|somofilcon A|Contact Lens
15846969|NCT04067141|Device|nelfilcon A|Contact Lens
15846970|NCT04067128|Behavioral|Health coaching|Brief telephonic intervention consisting of up to three phone calls
15846971|NCT04067115|Drug|Trabectedin 1 MG [Yondelis]|Patients with Ewing sarcoma will be administered trabectedin intravenously. Cycles are 21 days.
15846972|NCT04067115|Drug|Irinotecan|Patients with Ewing sarcoma will be administered inirotecan intravenously. Cycles are 21 days.
15846973|NCT04067115|Diagnostic Test|tumor biopsy|Tumor tissue samples will be collected collected at two timepoints. The first biopsy will be prior to treatment. If a biopsy is not possible archival tissue may be submitted. A second tumor biopsy will be taken fro consenting patients when possible after the first administration of Trabectedin to evaluate the effect on the tumor cells.
15847679|NCT04061369|Other|High fat meal|Meal consisting of conventional foods that is high (60% of energy) in fat calories.
15846976|NCT04067102|Drug|paclitaxel combined with carboplatin followed by epirubicin and cyclophosphamide|Paclitaxel 175mg/m2, I.v., d1； Carboplatin injection AUC 5, I.v., d1； 21 days in one cycle, 4 cycles in total.Continue the protocol when evaluated as CR/PR/SD at the second cycle, Terminate the protocol paclitaxel (albumin binding) combined with carboplatin when evaluated as PD at the second cycle，and use the EC protocol in advance or decide the next treatment protocol by the researcher
15846977|NCT04067089|Procedure|TAVR - Transcatheter aortic valve replacement|TAVR - Transcatheter aortic valve replacement with Acurate Neo bioprosthesis (Boston Scientific) using minimalist approach
15846978|NCT04067089|Procedure|Surgical aortic valve replacement|Surgical aortic valve replacement
15846979|NCT04067076|Other|Self-administered evaluation questionnaire|Smartphone app with MeMind questionnaires
15846980|NCT04067063|Other|Self-administered evaluation questionnaire|Smartphone app with MeMind questionnaires
15846981|NCT04067050|Device|comfilcon A asphere|Contact Lens
15846982|NCT04067050|Device|Spectacles|Habitual spectacles
15846983|NCT04067037|Drug|Camrelizumab|30mg, Intravenous administration on day 1 and day 15 of each 4-week cycle until disease progression or unacceptable toxicity develops, up to 6 cycles.
15846984|NCT04067037|Drug|Epirubicin|35mg/m2, Intravenous administration on day 1 and day 15 of each 4-week cycle until disease progression or unacceptable toxicity develops, up to 6 cycles.
15846985|NCT04067037|Drug|Vincristine|1.4mg/m2, Intravenous administration on day 1 and day 15 of each 4-week cycle until disease progression or unacceptable toxicity develops, up to 6 cycles.
15846986|NCT04067037|Drug|Dacarbazine|375mg/m2, Intravenous administration on day 1 and day 15 of each 4-week cycle until disease progression or unacceptable toxicity develops, up to 6 cycles.
15846987|NCT04067024|Procedure|Local anesthesia made by surgeon|infiltration with local anesthetics
15846988|NCT04067024|Procedure|Regional anesthesia group|Pecs block I and Supraclavicular nerf block
15846989|NCT04067011|Drug|Ciprofloxacin 500Mg Tablet|Ciprofloxacin 500mg administered by mouth every 12 hours. The antibiotic will be administered orally on Study Days 4-9, 22-24 and 31-37.
15846990|NCT04067011|Drug|Doxycycline 100Mg Tablet|Doxycycline 100mg administered by mouth every 12 hours. The antibiotic will be administered orally on Study Days 2-9, 22-24 and 32-38.
15846991|NCT04067011|Biological|AV7909|0.5mL AVA and 0.25mg CPG 7909 per 0.5mL dose.The vaccine will be administered intramuscularly on Study Days 8 and 23.
15846992|NCT04066998|Other|Tears sampling|Tears sampling
15846993|NCT04066998|Other|Lashes sampling|Lashes sampling
15846994|NCT04066985|Behavioral|Growth Mindset Online Single-Session Program|30minute self-administered program for youths
15846995|NCT04066985|Behavioral|Self-Kindness Online Single-Session Program|30minute self-administered program for youths
15846996|NCT04066985|Behavioral|Supportive Therapy Online Single-Session Program (Control)|30minute self-administered active comparator program for youths
15846997|NCT04066972|Other|Body-weight supported treadmill training in a room cooled to 16°C|A total of 30 training sessions will be conducted in 10 weeks for 30 minutes per session and 3 times per week in a cool room (16⁰ C) on a treadmill that is equipped with safety straps to prevent falls. A pneumatic harness system will be used to provide 10% body-weight support during training sessions. The participants will start exercising on the treadmill at 80% of their self-selected walking speed with 1% incline and will increase as per their tolerance (will progress weekly based on 40-65% heart rate reserve). Heart rate, perceived fatigue and rating of perceived exertion will be monitored continuously during exercise sessions. Initial training will commence with intermittent rest periods [1 to 5 minutes] as requested by the participants and will be progressed to a maximum of 30-minute continuous treadmill walking.
15846998|NCT04066959|Behavioral|Motivational Enhancement System (MES)|MES is a brief eHealth intervention delivered via an internet-based software application. MES is grounded in the Motivational Interviewing framework and the Information-Motivation-Behavioral Skills model of health behavior change. The goal of MES is to increase motivation to complete daily diabetes care tasks. MES consists of two 20-minute sessions that integrate psychoeducation with motivation-enhancing therapeutic exercises and behavioral goal setting.
15846999|NCT04066959|Behavioral|Question Prompt List (QPL)|A QPL is a list of questions related to the physical and psychosocial aspects of diabetes and treatment that youth may want to ask their physicians during a clinic visit. The theoretical foundation for the QPL resides in social-cognitive theory which posits that behavioral performance is a function of self-efficacy and behavioral expectations. Thus, the goal of a QPL is to increase self-efficacy and active participation in clinical care. QPL is completed within 14-days of a diabetes clinic visit and results in a personalized set of questions for youth to bring to their clinic visit.
15847000|NCT04066959|Behavioral|Text Message Reminders (TXT)|TXT is a behavioral support strategy composed of one-way text message reminders to promote daily diabetes care task completion. TXT is supported by social cognitive theory which suggests that consistent task completion leads to perceptions of control and supports goal attainment. TXT may also foster a stronger relationship with diabetes care providers through greater communication and satisfaction. Youth will receive daily reminders to complete key diabetes care tasks.
15847001|NCT04066946|Device|Microcurrent therapy|Micro current therapy is a therapy to treat humans / animals using electric current with amperages flowing in the μA range. The device offers 2 treatment methods: manual treatment, which requires manual input corresponding to the mentioned parameters, and automatic treatment which, depending on the clinical picture and the currently measured resistance between the electrodes, allows the device to automatically change the mentioned parameters. For this study the investigators use an automatic treatment with predefined settings. This automatic programme consists of a variation of 20 different frequency settings during 17 minutes. This programme is repeated one time which leads to a total treatment time of 34 minutes. The intensity setting for the treatment is between 200 and 350 µA. The treatment is applied 5x per week in the first 6 weeks. The treatment is stopped after six weeks.
15847002|NCT04066946|Other|Standard of care|"Standard of Care consists of:
~During the first two weeks:
~Histoacryl glue to close the surgical incisions.
~Suture strips to keep the wound closed.
~Isobetadine Dermicum as anti-septic treatment
~Dry wound dressings during the first 2 weeks.
~Tubigrip
~From two weeks until three months:
~• Hydration with hydrating crème 2x per day (not within 4 hours before microcurrent treatment.
~From three months onwards:
~• Silicone gel sheet."
15847680|NCT04061369|Other|High fat liquid meal|Liquid meal that is high (60% of energy) in fat calories.
15847003|NCT04066933|Combination Product|A2M enriched plasma|Plasma enriched for alpha2macroglobulin (A2M-PPP) was produced by a centrifugation and filtration process developed by Cytonics Corporation. Initially, 7 milliliters of Anticoagulant Citrate Dextrose Solution A, ubiquitous surface protein (USP) was drawn into a 60 cc syringe and then an additional 38 cc of autologous blood was drawn up through an antecubital vein. Two syringes were prepared in this manner and then centrifuged at 4000 rpm (1280G) for 4 minutes. The supernatant plasma fraction was then transferred to a roller pump system that circulates the fluid through a proprietary filter having a high molecular weight cutoff designed to trap larger molecules including alpha 2 macroglobulin (720 kDa).
15847004|NCT04066920|Drug|IBER salvage chemotherapy followed by ibrutinib maintenance therapy|Induction therapy with IBER (up to 6 cycles) [ Ibrutinib 560 mg/d on D1-21 + Rituximab 375 mg/m2 on D1 (on D1/8/15 in C1) + Ifosfamide 3.75 g/m2 on D2 + Etoposide 100 mg/m2 on D2-4 ], followed by ibrutinib 560 mg/d maintenance therapy for up to 6 months
15847005|NCT04066907|Other|Integrated Disease Management|Multidisciplinary intervention comprising of patient education, self management strategies and medication optimization
15847006|NCT04066894|Procedure|Explantation|Undergo lead removal
15847007|NCT04066894|Other|Quality-of-Life Assessment|Ancillary studies
15847008|NCT04066894|Other|Questionnaire Administration|Ancillary studies
15847009|NCT04066894|Device|Sacral Nerve Stimulator|Undergo sacral nerve stimulator implantation
15847010|NCT04066894|Device|Sacral Nerve Stimulator Battery|Undergo sacral nerve stimulator battery implantation
15847011|NCT04066894|Procedure|Therapeutic Conventional Surgery|Undergo sacral nerve stimulator implantation
15847012|NCT04066881|Biological|Vaccine Group A: DNA-HIV-PT123 and AIDSVAX® B/E (weeks 0,4,24,48)|"DNA-HIV-PT123 HIV vaccine includes three DNA plasmids that encode clade C ZM96 Gag, clade C ZM96 Env, and CN54 Pol-Nef.
~AIDSVAX® B/E is a bivalent HIV gp120 glycoprotein encompassing both subtype B (MN) and subtype E (A244) proteins that are adsorbed onto 600mcg of aluminum hydroxide gel suspension as adjuvant."
15847013|NCT04066881|Biological|Vaccine Group B: DNA-HIV-PT123 and CN54gp140+MPLA-L (weeks 0,4), then MVA and CN54gp140+MPLA-L (weeks 24,48)|"DNA-HIV-PT123 (see above)
~CN54gp140+MPLA-L. Recombinant CN54gp140 is a HIV-1 envelope protein from the clade C strain 97/CN/54 isolate, which comprises a sequence of 634 amino acids. MPLA is a non-toxic version of LipoPolySaccharide (LPS), which is isolated from the LPS lipid A region of Salmonella Minnesota R595 and retains the immune-stimulatory properties of LPS, but exhibits low toxicity.
~MVA-CMDR (Modified Vaccinia Ankara-Chiang Mai Double Recombinant) is a non-replicating, highly attenuated strain of Vaccina virus that has been genetically engineered to express the HIV-1 genes envgp160 CM235 Subtype E and gag and pol CM240 Subtype A (integrase-deleted and reverse transcriptase non-functional)."
15847014|NCT04066881|Biological|Vaccine Group C: Saline placebo (weeks 0,4,24,48)|Sodium Chloride (NaCl) for injection, 0.9%
15847015|NCT04066881|Drug|Control PrEP:TDF/FTC once daily (weeks 0-26)|Each tablet of Truvada contains 245mg of tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC), both of which are nucleot/side analogue HIV-1 reverse transcriptase inhibitors.
15847016|NCT04066881|Drug|Experimental PrEP:TAF/FTC once daily (weeks 0-26)|Each tablet of Descovy contains 25mg of tenofovir alfenamide (TAF) and 200mg of emtricitabine (FTC), both of which are nucleot/side analogue HIV-1 reverse transcriptase inhibitors.
15847017|NCT04066868|Other|Patient-reported outcomes assessment|Patient-reported outcomes are electronically assessed using EORTC QOL measures
15847018|NCT04066868|Other|CTCAE rating|CTCAE Ratings are conducted by clinicians
15847019|NCT04066868|Other|PRO data is displayed|PRO data is displayed right next to the CTCAE rating
15847020|NCT04066842|Other|Observation|Evaluation of Vitamin D levels and correlation of Vitamin D levels level with periodontal and cardiovascular disease
15847021|NCT04066829|Behavioral|Default setting intervention|All patients in the treatment group (patients undergoing tonsillectomy at Mott by pediatric otolaryngology attendings) will have clinicians who are exposed to the new default settings.
15847022|NCT04066816|Other|Walnuts|Participants will consume 2 ounces of walnuts for 21 days
15847023|NCT04066803|Drug|MTX|MTX group would be intervened by incremental MTX and folic acid，while the control group would be intervened by incremental original DMARDs they already used（including Leflunomide，Hydroxychloroquine,Sulfasalazine,Azathioprine,Tripterygium glycosides and Total glucosides of paeony)
15847024|NCT04066803|Drug|Folic Acid|MTX group would be intervened by folic acid，while the control group would be not intervened by folic acid
15847025|NCT04066803|Drug|DMARDs|including Leflunomide，Hydroxychloroquine,Sulfasalazine,Azathioprine,Tripterygium glycosides and Total glucosides of paeony
15847026|NCT04066790|Drug|Pyrotinib|Pyrotinib 400 mg taken orally everyday, every 3 weeks, for 4 cycles.
15847027|NCT04066790|Drug|nab-Paclitaxel|Nab-paclitaxel 100mg/m2 by intravenous (IV) infusion on day1, day8 and day15, every 3 weeks, for 4 cycles.
15847028|NCT04066790|Drug|Trastuzumab|Trastuzumab IV infusion in 3-week cycles. Neoadjuvant treatment: 8 milligrams per kilogram (mg/kg) loading dose for Cycle 1, followed by 6 mg/kg for Cycles 2-4. Adjuvant treatment: 8 mg/kg loading dose for Cycle 9, followed by 6 mg/kg for remaining cycles till completion of 1 year trastuzumab
15847029|NCT04066790|Drug|EC chemotherapy|epirubicin 90 mg/m2, and cyclophosphamide 600 mg/m2 by intravenous (IV) infusion every 3 weeks 4 cycles (Cycles 5-8)
15847030|NCT04066790|Procedure|Surgery|All participants who are eligible for surgery will undergo surgery and have their pathologic response evaluated.
15847031|NCT04066777|Procedure|alcohol septal ablation|injection of 1-4 mL of 96% ethanol into a septal perforator of the left anterior coronary artery to produce a myocardial infarction
15847032|NCT04066764|Drug|Rivaroxaban|15mg twice daily for 3 weeks after operation, later 20mg once daily until 3 months after the filter is removed. Application: oral
15847033|NCT04066764|Drug|Warfarin|3mg for 5 days after the operation, later 0.75mg to 18mg depending on INR (2.0-3.0) until until 3 months after the filter is removed. Frequency: once daily Application: oral
15847034|NCT04066764|Drug|Nadroparin|Dose: 1mg/kg Duration: 5 days after the operation Frequency: twice daily Application: subcutaneous
15847035|NCT04066751|Drug|Ivacaftor|Ivacaftor will be supplied as a tablet for oral administration, film-coated, 150 mg
15847036|NCT04066738|Diagnostic Test|Cardiac MRI with gadolinium contrast|Imaging of left ventricular scar and coronary sinus venous system
15847844|NCT04059965|Other|Usual Care|Patients will receive standard, protocolized care in their respective anticoagulation clinics
15847037|NCT04066738|Diagnostic Test|3D reconstruction and location of coronary sinus venous system relative to myocardial scar|Three dimensional mapping of coronary sinus venous system with Abbott Precision mapping system and Biotronik Vision wire Merge with MRI images of CS and myocardial scar
15847038|NCT04066738|Diagnostic Test|Acute haemodynamic measurements during CRT implant|Advancement of pressure wire to LV cavity via femoral/radial arterial access. Real time measurement of LV-dP/dTmax during conventional CRT and MPP after consecutive placement of LV lead in two different CS branches (peri-infarct region and remote myocardium)
15847039|NCT04066725|Drug|Aspirin 81 mg|Participants will be given ASA 81 mg orally once daily for a total of 60 days
15847040|NCT04066725|Drug|Aspirin 325mg|Participants will be given ASA 325 mg orally once daily for a total of 60 days
15847041|NCT04066725|Drug|Placebo oral tablet|Participants will be given placebo orally once daily for a total of 60 days
15847042|NCT04066712|Drug|LC350189 200 mg|Study drug in capsule form, take two capsules of LC350189 100mg, by oral, once daily, from Day 1 through 7
15847043|NCT04066699|Procedure|Percutaneous localization of suspicious lung lesion(s) using electromagnetic navigation and tools.|Transthoracic localization of suspicious lung lesion(s) in preparation for subsequent resection.
15847044|NCT04066673|Diagnostic Test|Stanford-Binet Intelligence Scale, 5th Edition|The SB5 is a descendent of the very first intelligence measure ever created. It tests general intellectual ability, and the Fifth Edition affords the ability to report Full Scale, Abbreviated, Nonverbal, and Verbal IQ scores
15847045|NCT04066660|Dietary Supplement|Oligo Fucoidan|4.4 g oligo fucoidan powder, oral, BID
15847046|NCT04066660|Dietary Supplement|Placebo|4.4 g placebo powder, oral, BID
15847047|NCT04066647|Drug|Dexamethasone 4mg|1 mg IV dexamethasone will be pushed and miRNA levels will be checked at baseline just before injection and then at 15, 30, 45, and 60 minutes after injection.
15847048|NCT04066634|Device|Vivio System|The Vivio Analysis Software is an analysis software that assists in identifying suspected systolic murmurs associated with aortic stenosis. The Vivio Analysis Software is used with the Vivio System, a non-invasive device used for the detection and amplification of sounds from the heart and arteries.
15847049|NCT04066621|Drug|Ceftriaxone Sodium and Sulbactam Sodium for Injection|daily dose was 75 mg/kg by weight, 1-2 times ivgtt per day, 4 to 14 days
15847050|NCT04066595|Drug|Cabozantinib|60 mg cabozantinib oral daily. When dose reduction is necessary, it is recommended to reduce to 40 mg daily, and then to 20 mg daily.
15847051|NCT04066582|Device|ApolloVue™ S100 image system, Viper1-S003|The device is an in vivo non-invasive optical coherence tomography and will be used to obtain at least 6 medical images of normal and lesional skin, respectively, for experimental group.
15847052|NCT04066569|Other|Performed 3 diagnostic tests (2 OGTT tests with 75 g of Glucose and 1 placebo test with 375 mg of Aspartam|"After inclusion, the study will include the sequential realization of 3 dynamic GH secretion tests, separated by a period of 24 hours to 30 days. Each subject will have two OGTT tests (oral administration of 75 g of glucose in 100 mL of water) and a placebo test (oral administration of 375 mg of aspartame in 100 mL of water). The order of the three tests (2 OGTT and 1 placebo) in acromegalic patients will be randomized.
~The tests will be performed under the same conditions"
15847053|NCT04066569|Other|Performed 2 diagnostic tests (2 OGTT tests with 75g of Glucose)|"After inclusion, the study will include the sequential realization of 2 dynamic GH secretion tests, separated by a period of 24 hours to 30 days. Each subject will have two OGTT tests (oral administration of 75 g of glucose in 100 mL of water).
~The tests will be performed under the same conditions (fasting, semi-recumbent position, start of the test at 9 am) and will include a measurement of blood glucose, GH, insulinemia at -15, 0, 30, 60, 90, 120 min after ingestion of glucose or placebo."
15847054|NCT04066556|Other|Brain CT imaging|"The investigators will analyzed the CT image that was performed in patients with hyperacute stroke. The CT protocol includes CT thrombus, collateral, core images. The investigators also obtain detailed history and laboratory and imaging result for comorbidity. The comorbidity index protocol is based on the Charlson comorbidity index.
~Cut-off values in thrombus volume and Hounsfield unit according to non-contrast CT images
~Cut-off values in areas of irreversible changes according to non-contrast CT images
~Cut-off values in occlusion sites and collateral scores according to CT angiographies
~Cut-off values of consolidated CT imaging index including clot, core, and collateral score
~Cut-off values of comorbidity index
~Medical care expenses according to comorbidity index in patients who received intravenous thrombolytic treatment and/or endovascular recanalization treatments."
15847055|NCT04066543|Device|TACE|The modified Seldinger puncture was used to puncture the cutaneous-femoral artery, insert the catheter and perform hepatic artery angiography. The location, morphology and blood supply of liver tissue lesions were comprehensively understood. The use of chemotherapeutic drugs and the dosage of iodized oil as the embolic agent were determined according to the general situation. The catheter was injected into the supply vessel of the tumor, and 5-FU and adriamycin were injected according to the situation. The embolic agent was injected with iodized oil as carrier, mixed with chemotherapeutic drugs at the same time, and then assisted with gelatin sponge for embolization. Antiemetic drugs were given before treatment and hepatoprotective drugs were given after operation. Until the disease progresses.
15847056|NCT04066543|Drug|Anlotinib Hydrochloride|Anlotinib hydrochloride capsule, according to the recommended dose, po, qd, continuous oral 2 weeks stop for 1 week, 3 weeks for a cycle.
15847057|NCT04066530|Drug|AD-203|AD-203 administered two times daily for two weeks
15847058|NCT04066530|Drug|Mucosta tab.|Mucosta tab. administered three times daily for two weeks
15847059|NCT04066517|Procedure|SBRT|Multimodal-imaging guided SBRT for VT ablation.
15847060|NCT04066504|Drug|sonidegib|Sonidegib 200 mg orally taken once daily (dose modifications according to the approved local country prescribing information are permitted)
15847061|NCT04066491|Drug|Bintrafusp alfa|Participants will receive Bintrafusp alfa intravenously at a dose of 2400 milligram (mg) once every 3 weeks (Q3W) until confirmed disease progression, death, unacceptable toxicity, study withdrawal or for 2 years after the first onset of Complete Response (CR).
15847062|NCT04066491|Drug|Placebo|Participants will receive Bintrafusp alfa matched Placebo intravenously once every 3 weeks (Q3W) until confirmed disease progression, death, unacceptable toxicity, study withdrawal or for 2 years after the first onset of CR.
15847063|NCT04066491|Drug|Gemcitabine|Gemcitabine will be received intravenously at a dose of 1000 milligram per meter square (mg/m^2) on Day 1 and Day 8 of 21- day cycle, for 8 cycles every 3 weeks (Q3W).
15847064|NCT04066491|Drug|Cisplatin|Cisplatin will be received intravenously at a dose of 25 mg/m^2 on Day 1 and Day 8 of 21-day cycle, for 8 cycles every 3 weeks (Q3W).
15847065|NCT04066478|Drug|Dehydroepiandrosterone|75mg Dehydroepiandrosterone daily
15847066|NCT04066478|Drug|Placebo|Placebo
15847067|NCT04066452|Diagnostic Test|Bone-cardiac scintigraphy with Tc-DPD (or similar: Tc-PYP or Tc-HMDP).|Bone-cardiac scintigraphy with Tc-DPD (or similar: Tc-PYP or Tc-HMDP) to evaluate the degree of cardiac uptake from 0 to 3 degrees.
15847068|NCT04066452|Diagnostic Test|Proteinogram and serum immunoglobulins. Light chains free in serum -Freelite-. Immunofixation in serum and urine|Analysis to rule out the presence of monoclonal protein in blood and urine.
15847069|NCT04066439|Other|specimen|Immunohistochemistry analysis
15847070|NCT04066426|Drug|naproxen sodium+codeine phosphate, naproxen sodium+dexamethasone, naproxen sodium, paracetamol|NSAID, steroid, opioid, paracetamol and combinations of this drugs can be used in temporomandibular disorders.
15847071|NCT04066413|Other|Standard infant formula|Standard infant formula
15847072|NCT04066413|Other|Infant formula supplemented with HMO|Infant formula supplemented with HMO
15847073|NCT04066400|Other|Nutritional Intervention|Dietary Counselling
15847074|NCT04066374|Device|Peripheral Nerve Stimulation|Medtronic Intellis Spinal Cord Stimulation Device to be implanted in thoracic cavity to treat postoperative acute pain.
15847075|NCT04066361|Other|Chatbot|Interactive text chat designed to mirror the educational components of a traditional genetic counseling visit
15847076|NCT04066361|Other|Video Education|Brief video designed to mirror the educational components of a traditional genetic counseling visit
15847077|NCT04066348|Biological|Etanercept|To treat blast or noise induced tinnitus
15847078|NCT04066348|Other|Saline|Placebo
15847079|NCT04066322|Procedure|system treatment and surgery|to patients with PR/SD after system treatment, investigator assess the tumor is resectable, and participants decide to receive Synchronous resection of primary tumor and metastasis. after surgery, the investigator decide further treatments.
15847080|NCT04066322|Other|system treatment|to patients with PR/SD after system treatment, investigator assess the tumor is resectable, and participants decide to continue take system treatment.
15847081|NCT04066309|Device|Neodent GM Helix Implant|4.0x10 mm Neodent GM Helix Implants will be placed 2mm subcrestally (in relation to the buccal bone plate) in the posterior region of the maxilla, under local anesthesia and with adequate bone bed preparation, as recommended by the manufacturer, using the guided surgery technique.
15847082|NCT04066309|Device|GM Customizable Healing Abutment|Customizable healing abutments will be placed at the time of implant placement.
15847083|NCT04066309|Device|GM Pro PEEK Abutment|Placement of temporary single prostheses (early loading), over temporary abutments.
15847084|NCT04066309|Device|GM Exact Titanium Base|Insertion of the final abutment (Titanium Base and Zirconia Coping), following the digital workflow.
15847085|NCT04066296|Drug|Liposomal bupivacaine|Injection of either liposomal bupivicaine or standard local anesthetic during surgical procedure.
15847086|NCT04066270|Diagnostic Test|video nystagmography|routine test battery applied to all cochlear implant candidates
15847087|NCT04066257|Drug|Tegoprazan|Tegoprazan 50 mg tablet
15847088|NCT04066257|Drug|Metronidazole|Metronidazole 250 mg tablet
15847089|NCT04066257|Drug|Tetracycline|Tetracycline hydrochloride 250 mg capsule
15847090|NCT04066257|Drug|Bismuth|Tripotassium bismuth dicitrate 300 mg tablet
15847091|NCT04066244|Drug|BLZ945|Investigational drug
15847092|NCT04066231|Device|VIPUN GMS|Motility is measured for 4 hours with the VIPUN Gastric Monitoring System (GMS).
15847093|NCT04066231|Drug|Erythromycin Lactobionate|"Test model: Erythromycin has gastroprokinetic properties. The primary aim of this investigation is to validate the ability of the VIPUN GMS to discriminate between normal and pharmacologically-enhanced fasting gastric motility in healthy adults.
~Erythromycin Lactobionate infusion: 200 mg i.v. infusion over a period of 20 minutes. Note: Erythromycin is not labeled as a gastroprokinetic agent in Belgium."
15847094|NCT04066218|Other|Interviews|"Participation will serve as verbal consent.
~Qualitative PRA will call participant to schedule either phone or in person interview. If via phone, the study PRA performing the interview, will remind them to find a private space to speak.
~REDCap link will be sent for PROMIS SexFS Brief.
~PRA will perform semistructured interview and guide Think-Aloud to complete the PROMIS SexFS Brief.
~Participants will not submit responses to PROMIS SexFS Brief responses after completing the tool."
15847096|NCT04066192|Drug|Brexpiprazole|Brexpiprazole will be used in .5mg, 1mg, 2mg, and 4mg doses as described in the study arms.
15847097|NCT04066192|Drug|Placebo|A medically inert placebo medication will be used as described in the study arms.
15847098|NCT04066179|Drug|Gcsf|Granulocytes-Colony Stimulating Factor 300 mcg for 7 days followed by 300 mcg every 3 days
15847099|NCT04066179|Drug|Prednisolone|Prednisolone 40 mg for initial 7 days
15847100|NCT04066166|Diagnostic Test|Palpation|All healthy subjects palpated
15847101|NCT04066140|Other|No intervention|No Intervention. Observational Study.
15847102|NCT04066127|Device|Non-ischemic heart preservation (NIHP)|The device is a miniaturized and fully automated heart-lung machine, housed in a portable device (weight 32 kg), that enables transportation between hospitals. The reservoir is filled with 2.5 liters of the perfusion solution plus approximately 500 mL compatible washed and leucocyte-filtered red blood cells from the hospital blood bank. The NIHP system software is adjusted to maintain a mean blood pressure of 20-25 mmHg in the aortic root, giving a coronary flow between 150 mL/min and 250 mL/min.
15847103|NCT04066127|Device|Standard ischemic cold static storage (SCS)|The device is a cool box that enables transportation between hospitals. The heart is stored on ice slush in the box at a temperature of approximately 4-8 °C.
15847104|NCT04066114|Biological|lulizumab pegol|25 mg subcutaneously (SC) on Day 1 post transplantation then 12.5 mg SC weekly through day 77 (Week 11)
15847105|NCT04066114|Biological|antithymocyte globulin (rabbit)|1.5 mg/kg intravenously (IV) on Day 0 (day of transplantation) and the day following (Day 1)
15847106|NCT04066114|Drug|methylprednisolone|500 mg (IV) on Day 0 (day of transplantation), 250 mg (IV) on Day 1 and 125 mg (IV) on Day 2
15847107|NCT04066114|Biological|tocilizumab|8 mg/kg (IV) on Day 2 post transplantation followed by 162 mg (SC) every 2 weeks through day 168 (Week 24)
15847108|NCT04066114|Drug|Prednisone|"Beginning on Day 3 post transplantation, taken orally: 60 mg daily
~Days 4 through 10: 30 mg daily
~Days 11 through 17: 20 mg daily
~Days 18 through 24: 10 mg daily
~After Day 24: continued taper of dose to final maintenance dose of 5 mg, per protocol"
15847109|NCT04066114|Drug|everolimus|Initial dose of 0.75 mg taken orally twice daily on Day 14 days after transplantation. Dose will be titrated to target trough levels 3-8 ng/mL.
15847110|NCT04066114|Biological|belatacept|5 mg/kg (IV) every 4 weeks starting on Day 84 (Week 12) and continuing through Day 364 (Week 52)
15847111|NCT04066114|Drug|mycophenolate mofetil|"An option for participants who do not tolerate everolimus: to be switched to either
~mycophenolate mofetil 1000 mg administered orally twice daily or
~mycophenolic acid"
15847112|NCT04066114|Drug|mycophenolic acid|"An option for participants who do not tolerate everolimus: to be switched to either
~mycophenolic acid 720 mg taken orally twice daily or
~mycophenolate mofetil"
15847113|NCT04066101|Genetic|high caries risk|DNAs were obtained from epithelial cells in buccal mucosa and were extracted with Genomic DNA Isolation Kit Genotyping for a variant was carried out on a Roche Applied Science LightCycler® 480 (Roche Diagnostics GmbH, Mannheim, Germany) with real-time polymerase reaction of Taqman
15847114|NCT04066101|Other|caries activity|"Dental caries lesions of all patient scored as initial, moderate or advanced caries
~Initial lesion; clinically detectable lesion Moderate; visible signs of enamel breakdown Advanced; enamel was fully cavitaed"
15847115|NCT04066088|Other|Placebo|Placebo will be administered same times as GXR
15847116|NCT04066088|Drug|Guanfacine extended release (GXR)|The starting dose for all subjects will be 1 mg per day. If the medication is well-tolerated, the dose can be raised to 2 mg until day 28 and increased to 3mg for the remaining 4 weeks in the trial. The dose schedule will not be fixed; the treating clinician can delay a planned increase or lower the dose to manage adverse effects. At week 8, the study will be unblinded and subjects will continue treatment for 8 more weeks.
15847117|NCT04066075|Behavioral|Low Vision Rehabilitation|Low Vision Rehabilitation for use of magnification devices for near reading tasks
15847119|NCT04066036|Other|This is an observational study only.|This is an observational study only.
15847120|NCT04066023|Drug|C213 Microneedle System|The C213 System is a proprietary disposable patch and a reusable applicator. The zolmitriptan-coated titanium microneedle array (3 cm^2 array) is attached to a 5 cm^2 adhesive patch.
15847121|NCT04066023|Drug|Placebo|The C213 System is a proprietary disposable patch and a reusable applicator. The placebo patch is a single use, 3 cm^2 Placebo (intracutaneous microneedle) system that contains no active ingredients.
15847122|NCT04066010|Other|Mobile application (BP-n-Me)|"The mobile app consisted of a series of features including (1) calendar reminders of when to take medications and the patient's antihypertensive medication regimen (2) a Call your Pharmacist button specific to patient's pharmacy, (3) a BP log in which the patient could enter blood pressure values that were automatically compared to goal values, (4) counseling points for lifestyle and adherence factors individually tailored to each patient and (5) lifestyle and medication adherence surveys."
15847123|NCT04065997|Device|HeartWare Ventricular Assist Device|The HVAD is an implantable centrifugal rotary blood pump that is implanted in the pericardial space and is designed to provide up to 10 L/min of blood flow from the left ventricular to the aorta. The HVAD System is comprised of three major components: the HVAD (pump) with inflow and outflow conduits, a Controller (microprocessor unit that controls the operation of the HVAD), and power sources (AC and DC power adapters that provide power to the Controller and implanted HVAD).
15847125|NCT04065971|Drug|2LHERP®|The treatment schema consists in taking the content of one capsule a day, 15-30 minutes before breakfast, on an empty stomach, sequentially, according to capsules' numerical order: 1 through 10. When capsule number 10 is taken, capsule 1 of the next blister should be taken on the next day to continue the treatment. The duration of treatment will be 6 months of continuous intake of the content of 1 capsule/day.
15847126|NCT04065971|Drug|Placebo|The treatment schema consists in taking the content of one capsule a day, 15-30 minutes before breakfast, on an empty stomach, sequentially, according to capsules' numerical order: 1 through 10. When capsule number 10 is taken, capsule 1 of the next blister should be taken on the next day to continue the treatment. The duration of treatment will be 6 months of continuous intake of the content of 1 capsule/day.
15847127|NCT04065958|Behavioral|Yoga-mindfulness|Body-mind therapy
15847128|NCT04065958|Behavioral|Patient education and physiotherapy|Lectures and physiotherapy
15847129|NCT04065945|Other|Completion questionnaires/providing biological samples|Participant completes baseline interview at enrollment, then completes questionnaires and provides biological samples at each scheduled study visit.
15847130|NCT04065932|Drug|BMS-986165-01|Participants will receive BMS- 986165 -01 in prototype formulation
15847131|NCT04065932|Drug|BMS-986165 Tablet|Participants will receive BMS-986165 in tablet form.
15847132|NCT04065932|Drug|Famotidine|Participants will receive a previously dosed BMS-985165-01 Prototype Tablet at the same dose level following administration of famotidine
15847133|NCT04065919|Drug|Liposomal bupivacaine|20mL EXPAREL+40mL bupivacaine 0.25% infiltrated into 5th intercostal space
15847134|NCT04065919|Drug|0.25% Bupivacaine with epinephrine|0.25% Bupivacaine with epinephrine at 1cc/kg total dose infiltrated into 5th intercostal space
15847135|NCT04065906|Behavioral|NIRS neurofeedback|Neurofeedback as a treatment for ADHD can be interpreted as a way to increase behavioral inhibition. A method to assess brain activity is functional near-infrared spectroscopy (NIRS), measuring hemodynamic correlates of neural activity.
15847136|NCT04065906|Drug|Methylphenidate or Tomoxetine|Methylphenidate is the first line drug of ADHD Tomoxetine is the second line drug of ADHD
15847137|NCT04065893|Procedure|Catheter ablation of ventricular arrhythmia|PVC or VT ablation
15847138|NCT04065893|Drug|Intensified medical therapy|Dosage increase / new onset of Betablocker / medical antiarrhythmic medication according to guideline and clinical practice
15847139|NCT04065880|Other|TachoSil®|topical absorbable fibrin sealant patch applied directly on the lung area with air fistula.
15847140|NCT04065880|Other|Neoveil®|bioabsorbable soft-tissue reinforcement material applied on the normal shape of the lung at the end of the operation.
15847141|NCT04065867|Behavioral|ICT activities|Family interventions using ICT to promote family communication, sharing happiness with family members, and well-being in the community.
15847142|NCT04065854|Behavioral|Intervention|Assessment, tailored strength and balance exercise programme, activity analysis and risk enablement advice, and assessment for environmental hazards. Tailored adherence support and supervision.
15847143|NCT04065841|Drug|Tropifexor|Tropifexor is a highly potent, specific and orally available non-bile acid agonist of the bile acid receptor FXR.
15847144|NCT04065841|Drug|Licogliflozin|Licogliflozin is a selective and potent inhibitor of the sodium glucose co-transporters (SGLTs) 1 and 2
15847145|NCT04065841|Other|Placebo|licogliflozin placebo + tropifexor placebo
15847146|NCT04065815|Other|Resistance Training|"Conventional Resistance Training:
~Nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted protein intake/day: 1.2 - 1.5 g per kg bodyweight) during a study period of 12 weeks combined with a resistance training program consisting of five exercises: exercises (chest, upper/lower back, abdominals, legs)
~1 set per exercise
~time-effort per session: ~20 min
~2 training sessions per week"
15847147|NCT04065815|Other|WB-EMS|"Whole-Body Electromyostimulation (WB-EMS):
~Nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted protein intake/day: 1.2 - 1.5 g per kg bodyweight) during a study period of 12 weeks combined with WB-EMS training:
~Stimulation protocol: Frequency of 85 Hz, pulse duration of 0.35 ms, stimulation period of 6 sec, resting period of 4 sec; patients perform simple exercises during the stimulation period following a video tutorial
~time-effort per session: ~20 min
~2 training sessions per week"
15847148|NCT04065815|Other|High-intensity interval training (HIIT)|"HIIT:
~Nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted protein intake/day: 1.2 - 1.5 g per kg bodyweight) during a study period of 12 weeks combined with high-intensity interval training (HIIT):
~supervised cycle-ergometer training at at 80-95% HRmax
~time-effort per session: ~15 min
~2 training sessions per week"
15847149|NCT04065815|Other|Combined HIIT and Resistance Training (Combi)|"HIIT combined with conventional Resistance Training:
~Nutritional therapy (individualized, protein-rich nutritional therapy and counseling; targeted protein intake/day: 1.2 - 1.5 g per kg bodyweight) during a study period of 12 weeks combined with a combined HIIT and resistance training program:
~HIIT:
~supervised cycle-ergometer training at at 80-95% HRmax
~time-effort per session: ~15 min
~1 training session per week
~Resistance Training:
~five exercises: exercises (chest, upper/lower back, abdominals, legs)
~1 set per exercise
~time-effort per session: ~20 min
~1 training session per week"
15847150|NCT04065802|Radiation|Stereotactic Radioablation|External, non-invasive radiation delivery to scar regions of heart to treat ventricular arrhythmias
15847151|NCT04065789|Drug|Carfilzomib|Carfilzomib on Days 1, 8, 15, of cycle numbers 1-9 and Days 1 and 15 only of cycle numbers 10-18, at a dose of 20 mg/m2 on day 1 of cycle 1; at dose of 56 mg/m2 on all subsequent once weekly dosing days. The quadruple regimen treatment will be administered for 18 cycles.
15847152|NCT04065789|Drug|Daratumumab|Daratumumab : 16 mg/Kg weekly for 8 weeks, then every 2 weeks for 16 weeks, and then every 4 weeks thereafter. The quadruple regimen treatment will be administered for 18 cycles.
15847153|NCT04065789|Drug|Lenalidomide|Lenalidomide (25 mg), administered on days 1-21 of 28-day cycle.In frail patients, Lenalidomide dose will be reduced according to 15 mg . The quadruple regimen treatment will be administered for 18 cycles.
15847154|NCT04065789|Drug|Dexamethasone|Patients will be treated with IV or oral dexamethasone (20 mg for fit and INT-FIT, 10 mg for frail), administered on Days 1-2, 8-9, 15-16, and 22-23 of each 28-day cycle for cycles 1-2 followed by weekly 20 mg dexamethasone on subsequent cycles; In frail patients, dexamethasone will be reduced to 10 mg . The quadruple regimen treatment will be administered for 18 cycles.
15847155|NCT04065776|Radiation|Hippocampal-avoidance proton therapy|Hippocampal-avoidance proton therapy
15847156|NCT04065763|Other|Ultrasound assessment of dural sac dimension|Dural sac dimension is assessed using ultrasonography in the lateral decubitus position for spinal anesthesia.
15847157|NCT04065737|Drug|Sintilimab|"Sintilimab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells.
~other name: IBI308"
15847158|NCT04065724|Other|Physical training as resistance and aerobic training.|
15847159|NCT04065711|Device|Soliton's Rapid Acoustic Pulse (RAP)|Treatment for the temporary improvement in the appearance of cellulite.
15847160|NCT04065698|Drug|RV521|Single doses of RV521 administered as the drug in capsule formulation when fed and as the dry powder blend formulation dispersed in water when fed and whilst fasting, each on a separate dosing day.
15847161|NCT04065685|Other|serious game named Go Wish|"The nurse led intervention Go Wish is composed of 36 cards presenting statements of personal needs, values, and beliefs about end-of-life care. The aim is to decide about what to put into the patient's file as care options and the subsequent appointments to name a potential surrogate or to elaborate ADs.
~Patient and relative (if participating) will meet their nurse twice:
~Session 1: patient the cards in three piles and to rank the ten most important. Session 2 without relative: the nurse reiterates the wishes of care and treatments previously expressed and links them to the state of health and symptoms of the patient and the current treatments and their possible evolution.
~Session 2 with a relative: the relative sort the cards based on his/her beliefs about the patient's expectation.
~Session 3 with a relative: the nurse bring together the patient and his/her relative to discuss the priorities selected independently, identify, and explore the similarities and differences."
15847162|NCT04065685|Other|usual care|Standardized information on anticipated directives (ADs): the imad nurse are trained to promote AD to clients to help nurses to describe and explain ADs, to identify and to mobilize the required interview condition to promote ADs to clients to facilitate and initiate discussion on ADs
15847163|NCT04065672|Drug|Low-dose IL-2|One million units of rhIL-2 was administered subcutaneously five days every week for 4 weeks and then twice a week for 8 weeks. All patients were followed up for 3 months after treatment.
15847164|NCT04065646|Other|Mobile|
15847165|NCT04065633|Drug|P3-Fast|200 mg (2 × 100 mg) PF-04965842 Phase 3 tablet formulation under fasted conditions
15847166|NCT04065633|Drug|Comm-Fast|200 mg PF-04965842 commercial tablet formulation under fasted conditions
15847167|NCT04065633|Drug|Vari-Fast|200 mg PF-04965842 variant tablet formulation with slower dissolution under fasted conditions
15847168|NCT04065633|Drug|Comm-Fed|200 mg PF-04965842 commercial tablet formulation under fed conditions
15847169|NCT04065620|Diagnostic Test|ambulatory blood pressure measurement|24-hour ABPM will be made using validated devices, following ABPM device should be programmed to take measurements every 30 minutes . Patients will be instructed in their use. Periods of activity and rest will be pre-determined in short windows: for Asian and European Countries daytime period will be defined between 10:00 and 8:00 pm; and night-time period between 00:00 am and 6:00 am. For Latin American Countries daytime period will be defined between 08:00 and 06:00 pm; and night-time period between 00:00 am and 6:00 am. For Africa daytime period will be defined between 08:00 and 06:00 pm; and night-time period between 11 PM and 5 AM In addition, the duration of ABPM (hours), the percentage of valid readings, and the mean SBP/DBP values during periods of activity, rest and in 24 hours will be recorded. Records with a duration <24 hours, those without one good reading per hour and those with <70% of satisfactory readings will be excluded
15847170|NCT04065607|Procedure|Reopen the abdomen to check missed pathology or abdominal washouts|Re opening of the abdomen once the patient is stabilized after 24-48 hours to check the missed injury after damaged control surgery in trauma and to control the sepsis in fecal peritonitis due to abdominal tuberculosis or typhoid perforation
15847171|NCT04065594|Procedure|PRP dressing|PRP dressing gel dressings for treatment of chronic ulcer
15847172|NCT04065594|Procedure|conventional ordinary dressing|conventional ordinary dressing for treatment of chronic ulcer
15847173|NCT04065581|Drug|Acarbose/Metformin FDC(BAY81-9783)|Single dose: 50 mg acarbose/500 mg metformin tablet, oral
15847174|NCT04065581|Drug|Glucobay|Single dose: 50 mg tablet, oral
15847175|NCT04065581|Drug|Glucophage|Single dose: 500 mg tablet, oral
15847176|NCT04065568|Device|DISKO-tool|The training program will be based on the initial assessments of functioning and disability and the patients' performance of the test exercises. Type and number of exercises per session, level of difficulty and number of repetitions (including proportion of repetitions to the right and left side of the body) will be set. The set training program is thereafter introduced and evaluated during the first follow-up by video communication with the patients.
15847177|NCT04065555|Drug|TAK-981|Intratumoral microdose injection by the CIVO device.
15847178|NCT04065555|Biological|Cetuximab|Intratumoral microdose injection by the CIVO device.
15847179|NCT04065555|Biological|Avelumab|Intratumoral microdose injection by the CIVO device.
15847180|NCT04065555|Combination Product|TAK-981 + Cetuximab|Intratumoral microdose injection by the CIVO device.
15847181|NCT04065555|Combination Product|TAK-981 + Avelumab|Intratumoral microdose injection by the CIVO device.
15847182|NCT04065529|Combination Product|Gelatin tannate (GT) + oral rehydration solution (ORS) + Zinc supplementation|Gelatin tannate (GT) + oral rehydration solution (ORS) + Zinc supplementation
15847183|NCT04065529|Combination Product|placebo + ORS + Zinc supplementation|placebo + ORS + Zinc supplementation
15847184|NCT04065516|Procedure|ARAT technique|After an initial endoscopic evaluation, ARAT technique will be performed with marking, submucosal elevation at esophagogastric junction and then ablation with 100-120w of 270-300 degrees at esophagogastric junction, once the application of the therapy is performed mucosal lavage and immersion technique will be made to corroborate integrity and continuity of the gastrointestinal tract and rule out immediate complications.
15847185|NCT04065503|Biological|Probiotic Strains|A commercial product containing L. helveticus R0052, L. casei HA-108, B. breve HA-129, and B. longum R0175 and S. thermophilus HA-110 be given to healthy adults across a 10-week open label pilot study.
15847186|NCT04065490|Device|Valeda PBM treatment|The Valeda Light Delivery System
15847187|NCT04065490|Device|Valeda Sham treatment|The sham mode of the Valeda Light Delivery System.
15847188|NCT04065477|Behavioral|computer-based cognitive rehabilitation (CBCR)|Program designed to improve strategic cognitive domains (e.g., complex attention, working memory)
15847189|NCT04065464|Device|Ava Fertility Tracker|All women aged 18 to 40 years using Ava Fertility Tracker to track their cycles.
15847190|NCT04065451|Drug|Epinephrine|Epinephrine in the submucosal injection fluid
15847191|NCT04065438|Device|LIPOSORBER® LA-15|"LIPOSORBER® LA-15 is a blood purification therapy; selectively removes apoprotein B-containing lipoproteins such as LDL from circulating blood and rapidly reduces the plasma cholesterol level. It was originally developed for prevention of coronary atherosclerosis progression in patients with serious hyperlipidemia such as familial hypercholesterolemia.
~In the late 1980's, LDL-A was used to improve dyslipidemia in Nephrotic Syndrome, initially to prevent organ damage. LDL-A was found to improve both the dyslipidemic condition and clinical symptoms (proteinuria and hypoproteinemia)."
15847192|NCT04065412|Procedure|Conventional laryngeal handshake technique|The conventional laryngeal handshake technique is performed with the non-dominant hand, identifying the hyoid bone and thyroid laminae, stabilizing the larynx between thumb and middle finger, and moving down the neck to palpate the cricothyroid membrane with the index finger.
15847193|NCT04065412|Procedure|Modified laryngeal handshake technique|The modified laryngeal handshake is performed with the non-dominant hand, stabilizing the trachea between thumb and middle finger from the suprasternal notch and moving up the neck to palate the cricoid cartilage and cricothyroid membrane with the index finger.
15847194|NCT04065399|Drug|SNDX-5613|SNDX-5613 orally
15847195|NCT04065399|Drug|cobicistat|Phase 1 Arm C patients will receive 150 mg cobicistat daily.
15847228|NCT04065126|Behavioral|Brief psycho-education|Two brief lectures with psycho-educational components, soon after baseline assessment and in connection to follow-up assessment.
15847198|NCT04065373|Device|ivWatch Model 400 with SmartTouch and fiber optic sensor|The ivWatch Model 400 with SmartTouch or fiber optic sensor monitored tissue at common IV sites over a 24 hour period.
15847199|NCT04065360|Behavioral|Group Cognitive behavioural family intervention (CBFI)|four-week, four-session CBT-based family intervention programme
15847200|NCT04065360|Behavioral|Usual group psychoeducation|Treatment as usual in the institution studied
15847201|NCT04065347|Device|Digital Pill|Digital Pill over encapsulating tenofovir alafenamide ART
15847202|NCT04065334|Behavioral|High dose training|4 x 4 minutes of high intensity workload on treadmill and 4 repetitions x 4 sets of high intensity workload in hack squat
15847203|NCT04065334|Behavioral|low dose training|1 x 4 minutes of high intensity workload on treadmill and 2 repetitions x 4 sets of high intensity workload in hack squat
15847204|NCT04065321|Procedure|PET-CT examination|All patients in the control group will undergo PET-CT examination after operation, and will reexamination once every 4 months in 2 years, every 6 months in 3-5 years, and every year in more than 5 years.
15847205|NCT04065321|Procedure|Peripheral blood detection|All patients in the trial group will be followed up after operation, and will reexamination once every 4 months in 2 years, every 6 months in 3-5 years, and every year in more than 5 years. Peripheral blood will be collected for detection of circulating tumor cells at each follow-up. If circulating tumor cells are abnormal (number of circulating tumor cells ≥ 2 or CD133 ≥ 1), PET-CT will be performed immediately.
15847206|NCT04065308|Drug|Drug Combinations|"Daratumumab plus DCEP,combination therapy is administered total of three cycles,every 4weeks(28 days).
~Daratumuamb 16mg/kg body weight in 500mL (the first dose,16mg/kg body weight in 1000mL) Weeks 1 to 8: weekly Weeks 9-24 : every 2 weeks if ASCT ineligible or PR but Plasmacytoma response <CR: every 2 weeks for 12weeks and then every 4 weeks for 8weeks (Total of 8 times, additional administration of daratumumab) if ASCT eligible: From 6 to 12 weeks after ASCT, administration of daratumumab is initiated within 12 weeks of ASCT and twice a month for 12 weeks and then every a months for 8 weeks. (Total of 8 additional administration of daratumumab after ASCT)
~dexamethasone :40mg/day D1-4, intravenous
~cyclophosphamide: 400mg/m2 D1-4, intravenous
~etoposide: 40mg/m2 D1-4, intravenous
~cisplatin : 7mg/m2 D1-4, intravenous Pegteograstim: 6mg once, SC on day 5 or 6 of each 28-day cycle"
15847207|NCT04065295|Drug|BI 1356225|Oral Dose
15847208|NCT04065295|Drug|Placebo|Oral dose
15847209|NCT04065282|Drug|Sintilimab|3 cycles before radical surgery
15847210|NCT04065282|Drug|Oxaliplatin|85mg/m2 Q3W, 3 cycles perioperation
15847211|NCT04065282|Drug|Capecitabine|1000mg/m2 bid po D1~14 Q3W, 3 cycles perioperation
15847212|NCT04065269|Drug|AZD6738|ATR inhibitor
15847213|NCT04065269|Drug|Olaparib|PARP inhibitor
15847214|NCT04065256|Other|Personalized music|Personalized music intervention will be conducted by research nurse independently. Firstly, the music preference will be confirmed by using predesigned music list. After confirming the music preference, participants will receive a music session for forty minutes through headphone and MP3 player.
15847215|NCT04065256|Other|Personalized music plus earplug|Personalized music intervention will be conducted by research nurse independently. Firstly, the music preference will be confirmed by using predesigned music list. After confirming the music preference, participants will receive a music session for forty minutes through headphone and MP3 player. In addition, participants will be worn earplug during night time sleep for decreasing the noise until next morning.
15847216|NCT04065243|Other|Overfeeding diet|Two weeks of overfeeding
15847217|NCT04065243|Other|Isocaloric diet|Two weeks of isocaloric weight maintenance
15847218|NCT04065230|Drug|Tenofovir Alafenamide Fumarate tablets|Eligible hepatitis B pregnant women are given TAF antiviral therapy (25mg, oral, 1/day) at 24-28 weeks of gestation until one month after delivery.
15847219|NCT04065217|Procedure|Diode laser 980-nm|Before starting the laser session, cosmetics or makeup were removed and the skin was cleaned. The area was anesthetized by the application of as EMLA lotion (lidocaine 2.5% + prilocaine 2.5%) [ONLY MEDICAL; CAT No. R331/72394/P001] 20 minutes before the session. During the procedure, the laser probe was held perpendicular to the lesion and a guide beam was used to direct the application. The patient wore protective eye goggles [CE; DIR 8001100L4]. After the session, cool air was applied to the whole region. Each patient received a maximum of six sessions, delivered at two-week intervals. Patients reported itchiness and erythema during the session.
15847220|NCT04065191|Other|High-intensity interval training|Heart rate based high-intensity interval training
15847221|NCT04065178|Behavioral|Level of activity|"Inpatients will be asked if they are willing to wear a heart rate tracking fitness watch during their stay. They will be asked quality of life questions on a questionnaire that will take approximately 30 minutes to answer at admission and discharge. At the end of the study they will return the Fitbit Charge 2 to the study coordinator or their nurse.
~Your rehabilitation plan of care will not change in any other way."
15847222|NCT04065165|Drug|Telotristat Ethyl|250 mg TID orally
15847223|NCT04065165|Drug|Lanreotide|120 mg Q4W deep subcutaneous injection in the superior external quadrant of the buttock or in the upper outer thigh
15847224|NCT04065152|Drug|Talimogene laherparepvec|Talimogene laherparepvec
15847225|NCT04065139|Drug|Pressurized intraperitoneal aerosol chemotherapy (PIPAC)|After insufflation of a 12 mmHg of capnoperitoneum at 37°C, two balloons safety trocars (10 and 12mm) are inserted into the abdominal wall. Injection of Doxorubicin (2.1 mg/m2 in 50 ml NaCl 0.9%) and Cisplatin (10.5 mg/m2 body surface in 150 ml NaCl 0.9%) with a flow rate of 0.7ml/s, the therapeutic capnoperitoneum is maintained for 30 min at body temperature.
15847226|NCT04065139|Drug|Standard chemotherapy|Patient will receive standard poly chemotherapy proposed by the oncologist or any new standard validated during the study, until progression or toxicity.
15847227|NCT04065126|Behavioral|Physical activity intervention|Ten sessions (two hours each) with physical activity and psycho-educational components.
15847229|NCT04065113|Procedure|Middle Meningeal Artery Embolization with polyvinyl alcohol particles (PVA)|Seal off blood supply to the middle meningeal artery to prevent growth of subdural hematoma
15847230|NCT04065113|Procedure|Drainage of Subdural Hematoma|Drainage of subdural hematoma via burrhole or craniotomy
15847231|NCT04065100|Diagnostic Test|Sebum test|Measuring sebum in newborn
15847232|NCT04065087|Biological|GX-I7|Investigational drug
15847233|NCT04065087|Other|Placebo|Placebo drug
15847234|NCT04065074|Drug|FX006 32 mg|Extended-release 32 mg FX006 IA injection
15847235|NCT04065061|Dietary Supplement|Erinacine A-enriched Hericium Erinaceus Mycelia|
15847236|NCT04065061|Dietary Supplement|Placebo|Placebo supplement was given to the participants.
15847239|NCT04065035|Other|Topical Body Firming Moisturizer|Moisturizer composed of a patent-pending blend of botanical extracts, bioavailable peptides, antioxidants, and a prebiotic innovation
15847240|NCT04065035|Other|Body Cleanser|Body cleanser to be used by study participants
15847241|NCT04065035|Other|Sunscreen|Sunscreen to be applied after application of moisturizer
15847242|NCT04065035|Other|Placebo Moisturizer|Placebo moisturizer is the vehicle control of the topical body firming moisturizer
15847243|NCT04065022|Device|tACS at tremor frequency|tACS applied between the stimulation electrodes at tremor frequency
15847244|NCT04065009|Drug|Ropivacaine|Experimental drug will be administered intraperitoneally
15847245|NCT04065009|Drug|Saline Solution|Placebo will be administered intraperitoneally
15847246|NCT04064996|Other|Routine rehabilitation program patient education|"Patient education
~All the patients were assessed with Wagner Classification, Diabetic Neuropathy Symptom (DNS) score, Diabetic Neuropathy Examination (DNE) score, Visual Analogue Scale (VAS), Leeds assessment of neuropathic symptoms and signs (LANSS), hand-held dynamometer, range of motion measurements, Semmes-Weinstein monofilament, two point discrimination test, circumference measurements, Foot and Ankle Ability Measure(FAAM), 6-minute walk test (6MWT) before and after the treatment."
15847247|NCT04064996|Other|Routine rehabilitation program + foot exercise training|"In addition to the patient education , foot exercise training will be performed. Patients will be applied exercise training consisted of aerobic, strengthening, sensory training and stretching exercises for 3 days/week, 8 weeks.
~All the patients were assessed with Wagner Classification, Diabetic Neuropathy Symptom (DNS) score, Diabetic Neuropathy Examination (DNE) score, Visual Analogue Scale (VAS), Leeds assessment of neuropathic symptoms and signs (LANSS) ,hand-held dynamometer,range of motion measurements, Semmes-Weinstein monofilament, two point discrimination test,circumference measurements, Foot and Ankle Ability Measure(FAAM), 6-minute walk test (6MWT) before and after the treatment."
15847248|NCT04064983|Biological|HB-adMSCs|Hope Biosciences autologous adipose-derived mesenchymal stem cells
15847249|NCT04064970|Behavioral|patient acceptable symptom state (PASS)|The Severity Index for Urinary Incontinence, which documents incontinence frequency and severity, pelvic floor distress, patient global impression of severity and improvement, physical function, depression, sleep disturbance, anxiety, global health and ability to participate in social roles and activities.
15847250|NCT04064957|Biological|HB-adMSCs|
15847251|NCT04064944|Device|blood purification equipment|The subjects enrolled in this study will undergo blood purification treatment, and will be randomized into either immunoadsorption group or plasma exchange group, and the following indicators will be evaluated: (1) changes in EDSS scores and visual acuity before and after treatment; (2) changes in AQP4-IgG levels; (3) the safety of immunoadsorption treatment.
15847252|NCT04064931|Diagnostic Test|Detection of niacin and other vitamins in plasma|Detection of niacin and other vitamins in plasma
15847253|NCT04064918|Other|Netarsudil 0.02% QD|This is a randomized, single-center, investigator-masked, 2-period, 8-week treatment study with washout and crossover between treatment periods. There will be 2 treatments in this study: netarsudil 0.02% QD and timolol maleate 0.5% BID.
15847254|NCT04064918|Other|Timolol maleate 0.5% BID|This is a randomized, single-center, investigator-masked, 2-period, 8-week treatment study with washout and crossover between treatment periods. There will be 2 treatments in this study: netarsudil 0.02% QD and timolol maleate 0.5% BID.
15847255|NCT04064905|Biological|mRNA-1893|Zika vaccine
15847256|NCT04064905|Other|Placebo|0.9% sodium chloride
15847257|NCT04064892|Behavioral|Exercise Intervention|The intervention will use peer mentors, motivational interviewing, and technology (Fitbit, Fitbit Coach App, & Fitbit message board) to support behavior change. All participants will receive phone or video calls from their peer mentors every other week, and interact with their peer mentor and other participants through a private Fitbit message board at least weekly. Peer mentors will use Fitbit data to identify participants who need additional support to increase their activity.
15847258|NCT04064879|Other|AD-SVF|Intravenous, intra-articular, and soft tissue injection delivery of SVF. Target regions include forehead, temporal, and suboccipital regions.
15847259|NCT04064866|Device|High yield pure PRP|"The investigational product is hemocyte autograft derived from the subject's own blood. Subjects with a clinical diagnosis of discogenic pain had a discogram with ¼ cc to ½ cc of contrast injected by hand (leaving up to ½ cc contrast in the needle lumen and connecting tube); any concordant pain will be noted. Subjects received the injectant delineated by coordinator-provided randomization. Subjects were awake for the entirety of study treatment procedure.
~All subjects had blood drawn (50 cc) from any access site and double-centrifuged using the EmCyte Hemocyte Autograft system; the first spin separated the buffy coat, the second spin and subsequent siphoning separated a purified platelet sample."
15847260|NCT04064866|Other|Placebo|Placebo injections will have saline placed in centrifuges and run for the duration required for PRP preparation. 3cc of saline will be placed in 3 cc syringes with opaque tape around the barrel to cover the fluid chamber. 1-2 cc of saline will be injected into the nucleus pulposus of each treatment level disc under fluoroscopy for lumbar; 0.5-1 cc for thoracic and 0.5-1 cc for cervical.
15847261|NCT04064866|Device|ProPlaz PPC|Trademarked name of an FDA-cleared product
15847262|NCT04064840|Drug|IVF: Decapeptyl and hCG|When at least three follicles reach 18 mm in diameter, recombinant hCG 0.25mg and decapeptyl 0.2mg will be injected subcutaneously.
15847263|NCT04064840|Drug|FET: Decapeptyl|On the day of FET, decapeptyl 0.1 mg will be injected subcutaneously.
15847264|NCT04064840|Drug|IVF: hCG and normal saline|When at least three follicles reach 18 mm in diameter, recombinant hCG 0.25mg and normal saline will be injected subcutaneously.
15847265|NCT04064840|Drug|FET: Normal Saline|On the day of FET, normal saline will be injected subcutaneously.
15847266|NCT04064827|Drug|Paricalcitol|Paricalcitol oral solution (2.5 mcg/mL) will be administered with an oral dispenser
15847269|NCT04064788|Other|Consecutive Modified Constraint-Induced Movement Therapy|Consecutive mCIMT group received 6 hours per day mCIMT sessions for consecutive 10 days. Accompanied by a physiotherapist in 1 hour of the 6-hour restriction period, the family was guided within the remaining period and the activities were adapted to daily life.
15847270|NCT04064788|Other|Traditional physiotherapy|Traditional physiotherapy within a specific program
15847271|NCT04064788|Other|Intermittent Modified Constraint-Induced Movement Therapy|Intermittent mCIMT group received mCIMT session 6 hours per day for 10 days, spread over 5 weeks (two days per week). Accompanied by a physiotherapist in 1 hour of the 6-hour restriction period, the family was guided within the remaining period and the activities were adapted to daily life.
15847272|NCT04064775|Behavioral|Smart snacking intervention|The smart snacking intervention aimed to examine whether peer-led nudging on social media influenced adolescents to reduce their self-reported ideal portion sizes for a variety of HED snacks and SSBs. In intervention 2, participants were randomly allocated to the intervention or control condition, and their ideal portion sizes were assessed through a survey at baseline and intervention end.
15847273|NCT04064762|Device|Paired Vagus Nerve Stimulation|Stimulation of the vagus nerve that is paired with Prolonged Exposure Therapy.
15847274|NCT04064749|Behavioral|Text messages|The brief intervention includes providing feedback on the individual's gambling score; providing an educational fact about the relationship between problem gambling and financial well-being; talking with the individual about the 'pros' and 'cons' of gambling with suggested strategies that could potentially reduce their gambling behaviors; and concluding with an action oriented closing question. Participants in the intervention group will also receive up to five text messages a week for one month.
15847275|NCT04064723|Device|Randomization between prosthetic components|Patients are randomized between two types of stem components and two types of cup components in total hip arthroplasty. Thus randomized between 4 different groups.
15847276|NCT04064710|Procedure|Vertebral Body Augmentation|Use allograft tissue in patients with one or two level, thoracic or lumbar T6-L5, vertebral compression fractures.
15847277|NCT04064710|Device|Manual Surgical Instruments|Lenoss Medical manual surgical access and cavity creation instruments will be used when implanting the allograft tissue.
15847278|NCT04064697|Drug|Valganciclovir|The experimental intervention consists of taking the treatment Valganciclovir 900 mg morning and evening for 3 weeks
15847279|NCT04064684|Drug|Budesonide|Enrolled patients will be treated with Pulmicort Respules®, Budesonide inhalation suspension [57], at a dose of 0.5 mg, nebulized twice daily through the mechanical ventilator.The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit. The maximum length of treatment will be 10 days.
15847280|NCT04064684|Drug|Placebo|Enrolled patients will be treated with normal saline.The medication will be administered to the patient by the respiratory therapist with the single-patient-use medication nebulizer attached to the mechanical ventilator circuit. The maximum length of treatment will be 10 days.
15847281|NCT04064671|Other|Implantation of the Zephyr ZSI 475 FTM erectile implant|Until recently, all penile implants were manufactured for erectile dysfunction in biological males and thus presumed the presence of two corpora cavernosa. In 2016 however, the Swiss company, Zephyr Surgical Implants (ZSI), created a 3-piece inflatable erectile device specifically for female-to-male transsexuals: the Zephyr ZSI 475 FTM. This prosthesis has a realistic gland shape, only one cylinder, and a specific anchorage device made of titanium and silicone to anchor the system to the pubic bone of the patient. These specific features could potentially address the aforementioned issues with implanting erectile devices in the neophallus and hopefully lead to better surgical outcomes in these particular patients.
15847282|NCT04064658|Procedure|Remote ischemic preconditioning|Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by a sphygmomanometer placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.
15847283|NCT04064658|Procedure|Sham remote ischemic preconditioning|Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by a sphygmomanometer placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.
15847284|NCT04064658|Procedure|Encephaloduroarteriosynangiosis|Encephaloduroarteriosynangiosis is an indirect revascularization surgery of moyamoya disease
15847285|NCT04064645|Device|Measurement of respiratory rate with DUT and comparison with reference|"The subject will follow the paced breathing app, once a stable Respiration Rate at the natural rate (without the breathing app) is captured. The breathing pattern on the app will be set to begin near the normal Respiration Rate of the subject and continue to go down by five intervals until reaching the Respiration Rate of 5 bpm. After that, we will pick back up at the rate above the subject's normal Respiration Rate and continue upwards until reaching 50 bpm or as high as the subject can tolerate up to 50 bpm.
~The respiratory rate will be monitored simultaneously with an EtCo2 (Reference) and the BORA BAND™ wristband monitoring system, Device Under Test. These data will be continuously recorded electronically. Additional study notes that describe conditions of the test as well as deviations, device issues and any adverse events will be recorded in written documentation."
15847286|NCT04064632|Drug|Rilpivirine + darunavir/cobicistat|Switch to a dual ART
15847287|NCT04064619|Drug|Solifenacin Succinate 5 MG|gradual weaning of drug vs. stopping
15847383|NCT04063813|Behavioral|Active Comparator: Sedentary trial|
15847923|NCT04059367|Drug|NNC9204-1177|Increasing doses of NNC9204-1177 administered s.c. (subcutaneously, under the skin) in the stomach area once-weekly for 11 weeks
15847288|NCT04064593|Diagnostic Test|Polygraphy|"The polygraphy consists of recording during sleep, respiratory flow by mean of a nasal cannula, respiratory movement by mean of a thoracic belt with inductance plethysmography, blood oxygenation and heartbeats by a fingertip transcutaneous oxymetry.
~Starting and ending of the recording will be programmed based on patient interview regarding usual sleep hours.
~Polygraphy data are anonymized before being sent to the Cloud and therefore to the core lab.
~Polygraphic data will be scored in centralized manner.
~Results of the polygraphy will be sent to the cardiology department with advice for treatment and follow-up.
~If necessary, the core-lab will provide tele-counseling regarding SDB management."
15847289|NCT04064580|Other|diagnostic test|performing a capnography examination
15847290|NCT04064567|Behavioral|PrEP-LINK|CHW will assist with healthcare and social service navigation and will utilize adherence counseling techniques. As per the model our intervention is based upon (the national Transitions Clinic Network [TCN]), our CHW has a history of incarceration. Participants randomized to the intervention group, the CHW will assist individuals with employment, housing (if needed), referrals to mental health or substance use treatment, keeping track of medical appointments and medication adherence.
15847291|NCT04064567|Other|Enhanced Standard of Care|Participants will receive education about PrEP and referral to a community PrEP provider which exceeds the standards of care these individuals would otherwise receive.
15847292|NCT04064554|Device|BCG vaccination with MicronJet600|BCG vaccination with MicronJet600
15847293|NCT04064554|Device|BCG vaccination with conventional needle|BCG vaccination with conventional needle
15847294|NCT04064541|Other|Virtual Visit|Virtual Visit
15847295|NCT04064528|Dietary Supplement|Amino Acids|10 g bolus of essential amino acids
15847296|NCT04064515|Diagnostic Test|Blood Assayed for CTCs|All study participants will have 15 mL of blood drawn for the purpose of the study.
15847297|NCT04064502|Diagnostic Test|CHRONIC ANKLE INSTABILITY AND ASSOCIATED FACTORS:|Questionnaire including sociodemographic information, general medical condition, history of orthopedic surgery, pain intensity, and the number of painful areas of the foot.
15847298|NCT04064489|Other|TRIPscore|TRIPcast score calculation
15847299|NCT04064476|Drug|Paliperidone Palmitate|This is a observational study, to see the effect of paliperidone palmitate on schizophrenia patient with violence risk. The intervention is determined by clinical practice in real world setting, only schizophrenia patient with violence risk and treated with Paliperidone Palmitate will be invited to join the observational study.
15847300|NCT04064463|Behavioral|Standard care|standard treatment for substance use disorders, along with sample monitoring
15847301|NCT04064463|Behavioral|Contingency management|Participants can earn reinforcement for attending group and abstinence from alcohol
15847302|NCT04064437|Diagnostic Test|Clinical tests|The investigators perform the following clinical tests: vibration threshold test, monofilament test, and height, weight and waist circumference measurement in every participant.
15847303|NCT04064437|Diagnostic Test|Clinical tests|The investigators perform the following clinical tests: height, weight and waist circumference measurement in every participant.
15847304|NCT04064437|Diagnostic Test|Biochemical tests|The investigators perform blood and urine tests in every participant.
15847305|NCT04064437|Diagnostic Test|DXA scan|The investigators perform a dual energy x-ray absorptiometry (DXA scan or osteodensitometry) in every participant.
15847306|NCT04064437|Diagnostic Test|AGE Reader|The investigators perform a skin AGE (advanced glycation end products) measurement with the AGE Reader machine in every participant.
15847307|NCT04064424|Other|Prevention video advertisement|Skin Cancer Prevention videos
15847308|NCT04064424|Other|Prevention images for advertisement|Skin Cancer Prevention images
15847309|NCT04064424|Other|No Advertisement|No skin cancer prevention videos or images were advertised.
15847310|NCT04064411|Combination Product|abaloparatide solid microstructured transdermal system|abaloparatide 300 μg applied to the thigh for 5 minutes once daily for 12 months
15847311|NCT04064411|Combination Product|abaloparatide-SC|abaloparatide 80 μg injected into the abdomen once daily for 12 months
15847312|NCT04064398|Procedure|Aspiration of gastric residuals|Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
15847313|NCT04064385|Device|FES Cycling|Stimulation parameters will be 450μs, 40Hz, and up to 140mA, these values will be changed if needed based on individual response. For example, stimulation to the gluteal muscles often may to be decreased to prevent autonomic dysreflexia. To receive correct stimulation parameters, stimulation intensity will be chosen to ensure a palpable muscle contraction and sensor tolerance. Each session will include a 2-minute warm-up and 2-minute cool-down of passive cycling. The unit automatically delivers enough stimulation to maintain a speed of 30 rotations per minute (rpm). Where this is not achieved, the leg cycle will assist the stimulated movement to maintain a speed of 30 rpm.
15847314|NCT04064372|Behavioral|Mindful response to adversity brief training|Participants will attend a group training session, led by a professional instructor, about responding to adversity with an approach of mindfulness, equanimity, and non-judgment, which will include a description of the skills, a writing and sharing activity focused on the proposed approach, and a practice session. Following the training, participants will be instructed to practice the skills that they just learned during a group version of a standard stress-induction task called the Trier Social Stress Task (the TSST-G).
15847315|NCT04064372|Behavioral|Strengths-based response to adversity brief training|Participants will attend a group training session, led by a professional instructor, about responding to adversity with an approach of strengths-based, narrative self-analysis, which will include a description of the skills, a writing and sharing activity focused on the proposed approach, and a practice session. Following the training, participants will be instructed to practice the skills that they just learned during a group version of a standard stress-induction task called the Trier Social Stress Task (the TSST-G).
15847316|NCT04064359|Drug|OBT076, a CD205-directed antibody-drug conjugate|Intravenous (IV) infusion of OBT076 every 3 weeks.
15847412|NCT04063540|Drug|Placebos|Treatment by Amiloride vs placebo in crossover
15847413|NCT04063527|Drug|adjuvant chemotherapy|combination of paclitaxel and carboplatin
15848519|NCT04054557|Behavioral|Behavioral Intervention|Use smart pill bottle
15847319|NCT04064333|Device|Slow-Stream Expiratory Muscle Strength Training|All participants will receive an initial visit for training on the therapy protocol, use of a weekly therapy log to track breaths, and use and maintenance of the EMST device. This will constitute the first EMST session and will be included in the therapy log as Week 1, Day 1. Each participant will have a minimum of seven weekly check-in visits from the research assistant and/or a member of the research team, where the EMST150 resistance will be recorded and adjusted to maintain training at 75% of their maximum load, as measured using the EMST150 device instruction manual. During these check-in visits, participants will provide their completed weekly therapy log and receive a new log.
15847320|NCT04064320|Behavioral|Lullaby intervention|Listening to lullabies, and accompanied by lullabies touching their abdomen and think about their babies of hospitalized women with high-risk pregnancy
15847321|NCT04064294|Drug|Intravenous Infusion|Intravenous levodopa given 1.0 to 1.5 mg/kg/hr from 0930 - 1130 on a single visit day.
15847322|NCT04064281|Other|the healthy Cantonese diet|After a 1-week run-in period, the intervention group will eat the healthy Cantonese diet for 4 consecutive weeks. Free meals will be provided 3 times a day (breakfast, lunch, dinner). The actually intake of every meal for all subjects will be recorded to estimate their nutrients intake. All subjects will be advised to avoid eating other food, but they should inform researchers of what they eat if they eat food that we will not provide.
15847323|NCT04064281|Other|the typical Cantonese diet|After a 1-week run-in period, the control group will still eat the typical Cantonese diet for 4 consecutive weeks. Free meals will be provided 3 times a day (breakfast, lunch, dinner). The actually intake of every meal for all subjects will be recorded to estimate their nutrients intake. All subjects will be advised to avoid eating other food, but they should inform researchers of what they eat if they eat food that we will not provide.
15847324|NCT04064268|Dietary Supplement|Whey|45 g whey + 20 g maltodextrin
15847325|NCT04064268|Dietary Supplement|3-OHB + Whey|50 g ketone + 45 g whey + 20 g maltodextrin
15847326|NCT04064255|Other|Practical Body Image (session 1 - 7)|Practical body image therapy
15847327|NCT04064255|Other|Practical Body Image (session 8 - 14)|Twice weekly mirror exposure plus ending session
15847328|NCT04064242|Drug|CMK389|single i.v. dose every 4 weeks
15847329|NCT04064242|Drug|Placebo|single i.v. dose every 4 weeks
15847330|NCT04064229|Device|The ivWatch Model 400 with SmartTouch and fiber optic sensor|The ivWatch Model 400 with SmartTouch or fiber optic sensor monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected.
15847331|NCT04064216|Procedure|Laparoscopic surgery|Patients that will undergo robot assisted laparoscopic surgery and conventional laparoscopic surgery for benign gynecologic disorders will answer 4 questionnaires to assess patient satisfaction, quality of life and cosmesis
15847332|NCT04064203|Other|Oral glucose tolerance test|50 grams OGTT
15847333|NCT04064203|Other|Clamp experiment|insulin-induced hypoglycaemic clamp followed by an 50 grams OGTT
15847334|NCT04064190|Drug|Vactosertib(TEW-7197)/ Durvalumab|Vactosertib (PO) in combination with Durvalumab (IV) every 4 weeks
15847335|NCT04064177|Device|NICAS cardiac output monitor|Non-invasive continuous cardiac output monitoring device using total body bioimpedance.
15847336|NCT04064164|Behavioral|Speeko for Elderspeak|Speeko for Elderspeak is a communication feedback IOS application.
15847337|NCT04064151|Behavioral|My Guide|12-week long health promotion Smartphone application
15847338|NCT04064138|Procedure|Peritoneal block|At the beginning of surgery, immediately after insertion of the first port 2 mg/kg lidocaine and 25mg/kg magnesium sulfate and 1/200 000 epinephrine in a total volume 50 ml (completed with saline .9%) will be given intra-peritoneal 10 min before the surgeon proceeds . At the end of the surgery another similar lidocaine-magnesium-epinephrine injection will be instillated before removal of the last port and the drain will be kept closed for 30 min.
15847339|NCT04064138|Procedure|Ultrasound guided erector spinae plane block|Before general anesthesia, ESPB will be performed under ultrasound guidance. The linear ultrasound transducer will be placed in a longitudinal parasagittal orientation 3 cm lateral to the T9 spinous process. The erector spinae muscles will be identified superficial to the tip of the T9 transverse process. The patient's skin will be anesthetized with 3 mL of 2% lidocaine. A 21 gauge 10cm needle will be inserted using an in plane superior to inferior. The tip of the needle will be placed into the facial plane on the deep aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process on ultrasonographical imaging. The calculated dose of lidocaine (2mg/kg) with 150 mg MgSo4 and 1/200 000 epinephrine will be injected on each side.
15847340|NCT04064138|Other|General anesthesia|General anesthesia
15847341|NCT04064125|Drug|FMX-101|
15847342|NCT04064112|Procedure|S-BLR|Surery of slanted bilateral LR recession for CI-IXT patients
15847343|NCT04064112|Procedure|C-BLR|Surery of conventional bilateral lateral rectus recession for CI-IXT patients
15847344|NCT04064099|Device|Custom-fitted sports mouthguard|Pressure dual laminated technique will be used to fabricate the mouthguards. Ethylene-vinyl acetate (EVA) thermoplastic sheets of 3 mm in thickness with 125 mm diameter (Dentsply International Raintree Essix, Court East Sarasota, USA) will be used. Two 3 mm sheets pressure-laminated together should form an even thickness of 4 mm mouthguard. The design of the mouthguards takes into consideration of the following limits: (i) the labial borders of the mouthguard were extended to within 2 mm of the vestibular reflection, (ii) the palatal margins were trimmed to the cervical area of the palatal surface of the upper teeth, (iii) enclosing the maxillary teeth to the distal surface of the first molars.
15847345|NCT04064086|Other|Comprehensive Pre-ESRD Patient Education (CPE)|Structured education session/s
15847346|NCT04064086|Other|Provision of the freely available resources for Kidney Disease Education|freely available resources
15847347|NCT04064073|Drug|DWP16001|Tablets, Oral, once daily single dose
15847348|NCT04064073|Drug|Metformin IR|Metformin IR 1000mg, Tablets, Oral, BID for 7 days
15847349|NCT04064073|Drug|DWP16001+Metformin IR|Tablets, Oral, once daily single dose DWP16001 Metformin IR 1000mg
15847448|NCT04063189|Drug|Clarithromycin Lenalidomide Dexamethasone (BiRd) Regimen|Clarithromycin 500mg，po，bid，d1-21; Lenalidomide 25mg，po，daily，d1-21 (dose according to creatinine clearance rate); Dexamethasone 20mg，po，daily，d1-2, 8-9,15-16, 22-23
15847449|NCT04063163|Drug|HLX10|HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.
15847350|NCT04064060|Drug|Luspatercept|Luspatercept (ACE-536), an erythroid maturation agent, is a recombinant fusion protein consisting of a modified form of the extracellular domain (ECD) of the human activin receptor type IIB (ActRIIB) linked to the human immunoglobin G 1 (IgG1) Fc domain. ActRIIB receptor and its ligands are members of the transforming growth factor-β (TGF-β) superfamily. Members of the TGF-β superfamily ligands, through their binding to activin receptors, are involved in modulating the differentiation of late-stage erythrocyte precursors (normoblasts) in the bone marrow. Luspatercept for injection is formulated as a sterile, preservative-free, lyophilized cake/powder. Luspatercept for injection is available in 25 mg and 75 mg vials and when reconstituted with water for injection, each consists of 50 mg/mL luspatercept in a 10 mM citrate buffer-based solution
15847351|NCT04064047|Procedure|Trans rectal ultrasound guided prostate biopsy|The investigators checked visual analogue scale of pain at different time periods: prior to probe insertion, during probe insertion. during probe manipulation in the rectum, during performance of periprostatic nerve block, during actual biopsy collection and at termination of procedure.
15847352|NCT04064047|Procedure|Trans rectal ultrasound|Performing a prostate biopsy using a transrectal ultrasound probe - the BK pro focus 2202 transrectal ultrasound and the 8808 bi-plane transrectal probe
15847353|NCT04064047|Procedure|Prostate biopsy|Prostate biopsy guided by a transrectal ultrasound with an 18 gauge needle
15847354|NCT04064047|Procedure|Periprostatic nerve block|Performing a bilateral peri-prostatic nerve block with 10 mL of 1% lidocaine (5 mL on each side)
15847355|NCT04064034|Other|Lateral Flow Assay (LFA)|Test to detect the Quiescin Sulfhydryl Oxidase 1 (QSOX1) protein
15847356|NCT04064021|Procedure|Acupunture|Patient will receive 12 acupuncture treatments over 6 weeks (2x per week)
15847357|NCT04064008|Device|PROFEMUR® Z Revision Femoral Stem|Total Hip Total Hip Arthroscopy
15847358|NCT04063995|Device|Repetitive transcranial magnetic stimulation|Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive intervention that uses magnetic fields to stimulate nerve cells to improve the symptoms of a variety of disorders, including stroke-related motor impairment.
15847359|NCT04063982|Other|none, only assessment at different time points|assessment at different time points
15847360|NCT04063969|Other|Assessment of radiation safety climate|"The rating tool contains 28 statements which cover 5 dimensions (Leadership, communication, commitment, resources, risk awareness) of the radiation safety climate. Participants are asked to indicate on a scale of 1 (completely disagree) - 3 (neutral) - 5 (completely agree) whether they agree with each statement. A composite radiation safety climate score is calculated by adding ratings on all items.
~Minimum scale score 28 - Maximum scale score 140"
15847361|NCT04063969|Other|Assessment of radiation safety behavior|The rating tool contains 2 statements which cover 2 dimensions of the radiation safety behavior. Participants are asked to indicate on a scale of 1 (completely disagree) - 3 (neutral) - 5 (completely agree) whether they agree with each statement. A composite radiation safety behavior score is calculated by adding ratings on both items Minimum scale score 2 - Maximum scale score 10
15847362|NCT04063969|Other|Assessment of radiation safety knowledge and motivation|"The rating tool contains 2 statements which cover the radiation safety knowledge and behavior. Participants are asked to indicate on a scale of 1 (completely disagree) - 3 (neutral) - 5 (completely agree) whether they agree with each statement.
~Minimum item score 1 - maximum item score 5"
15847363|NCT04063969|Other|Data collection|Collection of patient-related data points Demographic information: ASA-classification, BMI Procedure related information: Procedural time, approach, contrast usage case difficulty Radiation safety parameters: Air Kerma, DAP, fluoroscopy time
15847364|NCT04063956|Behavioral|multi-domain internet-based adaptive training program|The training paradigms include a time perception task, visual search task, rapid serial presentation task, delayed match to sample task, paired-associate recall task, attention span task, digit span task, go-no go task, Stroop task, task switching, auditory span task and n-back working memory task. Each task has several difficulty levels. The tasks are grouped in different cognitive domains including: processing speed, attention, perception, long-term memory, working memory, calculation, executive control, reasoning, and problem-solving. Participants in the cognitive training group will complete 40 min of training daily, 4 days a week for 12 weeks. When a high accuracy (80%) is achieved for each task, the level of difficulty will be upgraded for that task.
15847365|NCT04063956|Behavioral|active-control program|For the control group, tasks for processing speed and attention are included. Importantly, a fixed, primary difficulty level for all participants in the control group is set.
15847366|NCT04063943|Device|Sidus Stem-Free Shoulder|Device: Sidus Stem-Free Total Shoulder Arthroplasty System
15847367|NCT04063930|Drug|LOKELMA 5 GM Powder for Oral Suspension|Sodium zirconium cyclosilicate (a hyperkalemia treatment)
15847368|NCT04063930|Drug|Placebos|Matching placebo
15847369|NCT04063917|Device|ZENS|ZENS transcutaneous nerve stimulator (ZENS Device), a wearable and non-invasive device which stimulates nerves in the neck to reduce airway obstruction and maintain muscular tension while sleeping to reduce snoring severity.
15847370|NCT04063904|Drug|Mifepristone|One 200 mg pill (oral)
15847371|NCT04063904|Drug|Misoprostol|Two 400 mcg pills (sublingual)
15847372|NCT04063891|Device|Low-magnitude high-frequency vibration (LMHFV)|Low-magnitude high-frequency vibration (LMHFV) is a biophysical intervention that provides non-invasive, systemic mechanical stimulation and has been reported to have no adverse effect.
15847373|NCT04063891|Device|Low-magnitude high-frequency vibration (LMHFV)|Placebo group will have sham treatment by standing on the LMHFV platform for 20 minutes/day
15847374|NCT04063878|Device|Conometric Abutment and Conometric Final Cap|Conometric concept developed by Dentsply Sirona Implants for implant systems Ankylos, Astra Tech Implant System and Xive.
15847375|NCT04063865|Drug|Tacrolimus|Tacrolimus (FK / Prograf) titrated to a goal trough of 6 - 8 ng/ml
15847376|NCT04063865|Drug|Everolimus|Everolimus monotherapy - target trough levels 4 - 8 ng/ml as maintenance immunosuppression
15847377|NCT04063839|Drug|Elbasvir / Grazoprevir Oral Tablet|HCV treatment according to Norwegian guidelines
15847378|NCT04063826|Device|PET MRI|All participants will have a liver scan
15847379|NCT04063813|Behavioral|Experimental: 40 minute up trial|
15847380|NCT04063813|Behavioral|Experimental: 40 minute down trial|
15847381|NCT04063813|Behavioral|Experimental: Two 20 minute up trials|
15847382|NCT04063813|Behavioral|Experimental: Two 20 min down trials|
15847384|NCT04063787|Device|Fist Assist|"The Fist Assist device works by applying pressure to the subject's arm in the area where their arteriovenous fistula will eventually be created. The device is mobile and battery powered.
~The Fist Assist device will be assigned to each enrolled subject by randomization code. All subjects will be asked to use their assigned device twice daily, for two 2-hour sessions, once in the morning and once in the evening. Patients will apply the device to the non-dominant arm above the level of the elbow, and to keep a written log to record use, complications and any problems. They will be asked to do this for 3 months, and will come in to be evaluated via study visits at Months 3, 6, 9 and 12."
15847385|NCT04063774|Diagnostic Test|Dengue calculator|Clinical diagnostic algorithms of dengue generated by discrete and continuos Bayes formulas installed in a mobile device
15847386|NCT04063761|Device|esophageal cooling device (Attune Medical, Chicago, IL)|Prospective, single center pilot study
15847387|NCT04063748|Behavioral|Audiological rehabilitation|Experimental: tablet-based take-home auditory-cognitive training, which consists of phoneme tasks, words in quiet and in different types of noise
15847388|NCT04063748|Behavioral|Placebo Rehabilitation|Placebo: tablet-based take-home psychophysical tasks, reading (non auditory)
15847389|NCT04063735|Dietary Supplement|Cordyceps Cicadae Mycelia|Cordyceps Cicadae Mycelia supplement for 3 months
15847390|NCT04063735|Dietary Supplement|Placebo|Placebo was given to participants.
15847391|NCT04063722|Procedure|modified Benelli procedure|use of modified Benelli procedure for surgical treatment of gynecomastia
15847392|NCT04063709|Diagnostic Test|Acoustic Radiation Force Impulse (ARFI) ultrasound|ARFI imaging is an ultrasound-based, noninvasive imaging method and will be used in accordance with approved labeling.
15847393|NCT04063683|Drug|Anlotinib Hydrochloride, Paclitaxel, cisplatin|"anlotinib: 1 capsule (10mg) once a day, d1-d14 per cycle, 3 weeks for a treatment cycle.
~Paclitaxel: intravenously infused at 135mg/ m2, administered d1 per cycle, 3 weeks for a treatment cycle.
~Cisplatin: administered after paclitaxel, intravenously infused at 60-75 mg/m2, divided into d1-d3 medications per cycle; 3 weeks for one treatment cycle."
15847394|NCT04063670|Other|Video Intervention|Peri-operative video series focusing on expanded education and coping skills before and after scoliosis surgery for adolescent idiopathic scoliosis
15847395|NCT04063670|Other|Control|Routine, Standard-of-Care
15847396|NCT04063657|Procedure|External fixator|Patients will be placed in an external fixator followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.
15847397|NCT04063657|Procedure|Splinting|Patients will be placed in a short leg splint followed by open versus closed surgical stabilization of their calcaneus fracture when their soft tissue is appropriate for surgery.
15847398|NCT04063644|Device|Vis Glyc Neo|1 drop in each eye, three times a day.
15847399|NCT04063644|Device|Physiological saline solution|1 drop in each eye, three times a day.
15847400|NCT04063618|Procedure|Osteopathic Manipulative Therapy|The OMT practitioner, using a strong anatomic knowledge base, applies specific genital forces in the dysfunctional area, thus providing aid to the body's innate mechanisms of healing. During OMT, a patient's muscles, joints, and tissues are moved using techniques that include stretching, gentle pressure, and resistance.
15847401|NCT04063618|Procedure|Standard of Care Concussion Treatment|Standard of care for concussion management is cognitive rest, meaning no stimulation (or as little as possible). This mean no TV/phones/music/school/homework generally for 24 hours. After that a return to academic work is typically started. Once patient is symptom free for 24 hours, then the return to play protocol is initiated (this takes 7 total days to complete at a minimum).
15847402|NCT04063605|Other|Clinical Pilates|This exercise model focus on the awareness of the neutral position of the spine and strengthen the deep postural muscles of the spine. Training of trunk muscles is emphasized and trunk stabilization is achieved and more difficult activities are initiated and thus, body awareness is improved. There are general principles to be followed during exercises. These; The principle of concentration is respiration, central focus, control, stability and isolation. These principles are achieved by simultaneous muscle activation of muscles responsible for trunk stabilization (multifidus, diaphragm, transversus abdominis and pelvic floor muscles). In order for an exercise to become a clinical pilates exercise, trunk stabilization must be ensured and breath control should be established in each exercise.
15847403|NCT04063605|Other|Classic Physiotherapy|This exercise program will include strengthening, stretching, posture exercises, balance and gait exercises. Aim is to improve muscle strength and prevent shortness of muscles. Also, balance and gait exercise aim to improve walking capacity.
15847404|NCT04063592|Procedure|Residual limb revision|Surgical procedure involving construction of agonist-antagonist myoneural interfaces (AMIs)
15847405|NCT04063579|Diagnostic Test|Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP), cardiac catheterization|Imaging, blood tests, LV pressure measurement
15847406|NCT04063579|Diagnostic Test|Cardiac Magnetic Resonance, Echocardiogram, Blood investigation (NT-proBNP)|Imaging and Blood tests
15847407|NCT04063566|Procedure|Magnetic Resonance Imaging (MRI)|Prostate cancer screening MRI
15847408|NCT04063566|Procedure|Prostate-specific antigen (PSA) test|Blood test for PSA levels
15847409|NCT04063553|Other|Volunteers Service|"Subjects in the intervention group will receive standard physiotherapy care and an additional volunteers session once a day for at least 3 times during their stay in the hospital. The volunteer will set up the TKR exercise video for the subjects, then supervise or guide the subjects with the exercises.
~All volunteers are recruited from TTSH volunteers pool managed by Center of Health Activation (CHA). TKR volunteers are trained by the study team, including a formal classroom session and a practical and role play session. After the training, volunteers need to pass 3 assessment by the physiotherapists in order to attend to patients independently by themselves. Volunteers who are bilingual will attend to the subject alone, or else those who can only converse in Chinese/ English will pair up with another volunteer who knows another language to make sure there is no communication barrier between volunteers and patients."
15847410|NCT04063553|Other|Exercise brochure|. The control group subjects will receive only standard physiotherapy care and they will be instructed to perform 1 set of exercises daily following a brochure given. The exercises in the brochure and exercises taught by the volunteers are the same. The video and brochure are available in both English and Chinese version.
15847411|NCT04063540|Drug|Amiloride|Treatment by Amiloride vs placebo in crossover
15847414|NCT04063514|Other|Focused Ultrasound|With focused ultrasound, there is an expected accentuation of local perfusion and potential temporary opening of the blood brain barrier with the aim is to provide better delivery of therapeutic agents including medication, particulates and cellular elements for treatment of neoplastic, inflammatory and degenerative brain diseases. The present study seeks to investigate differences in perfusion between areas treated and untreated by this modality in order to further explore its use in clinical application for the treatment of brain disease.
15847415|NCT04063501|Other|Bronchoscopy|The patient will then return within a week for a research bronchoscopy to sample the upper and lower airways
15847416|NCT04063501|Other|Research Procedures|electrocardiogram, blood work (CBC, chemistry, coagulation profile and liver function tests, pregnancy test if applicable), X-ray and pulmonary function (spirometry) testing, and provide the patient with a stool collection kit.
15847417|NCT04063488|Drug|Metreleptin|This is an observational study in which the subjects will serve as their own controls. Study testing will be conducted at baseline (pre-treatment) and for 2 years, post-treatment with metreleptin.
15847418|NCT04063475|Drug|cyanoacrylate tissue adhesive beside sutures|using cyanoacrylate tissue adhesive for FGG fixation
15847419|NCT04063462|Drug|Pyrotinib|pyrotinib, single agent, 400mg p.o once daily until disease progressed
15847420|NCT04063449|Drug|endostar/PD-1 inhibitor|Antiangiogenic therapy plus immunotherapy and chemotherapy
15847421|NCT04063449|Drug|endostar|Antiangiogenic therapy plus chemotherapy
15847422|NCT04063436|Device|New nasal pillows mask with PAP therapy|Participants will be placed in the experimental arm for 14±5 days, during which they will be using the new nasal pillows mask for PAP therapy.
15847423|NCT04063423|Procedure|blood sample|Blood sample at start and at the end of the dialysis session; membrane scoring after dialysis; total cell volume measurement of dialyzer after dialysis; micro-CT of dialyzer after dialysis.
15847424|NCT04063410|Procedure|Angiography|Undergo standard of care CTA
15847425|NCT04063410|Procedure|MRI-Based Angiogram|Undergo pPCA
15847426|NCT04063410|Other|Quality-of-Life Assessment|Ancillary studies
15847427|NCT04063397|Diagnostic Test|Echocardiogram|Serial echocardiograms will be done on all patients pre-delivery, and at 3-6 months
15847428|NCT04063397|Diagnostic Test|Blood draw|Serial blood draws at same time points as echocardiograms for biomarker levels
15847429|NCT04063384|Other|alcohol beverage|Participants will be provided alcohol during study visits and changes in behavior/neural activity after consuming alcohol will be examined.
15847430|NCT04063384|Other|Placebo beverage|placebo beverage conditions.
15847431|NCT04063371|Other|Self-Administered Gerocognitive Examination (SAGE) or Electronic Self-Administered Gerocognitive Examination (eSAGE)|The Self-Administered Gerocognitive Examination (SAGE) is a reliable and valid assessment that is used to detect MCI and early dementia. It is a pen and paper assessment that has 4 interchangeable versions. The digital version of SAGE (eSAGE; commercially known as BrainTest®) is made for tablet use, consists of the identical test questions as SAGE, and is strongly associated with the validated SAGE.
15847432|NCT04063371|Other|Informant Conversation|If possible, the provider will have a conversation with an individual who knows the patient will to ascertain if a significant change (based on primary care provider opinion) occurred in the patient's cognitive skills over the previous year.
15847433|NCT04063358|Drug|Lucentis|Lucentis 0.5 MG Per 0.05 ML Injection
15847434|NCT04063345|Procedure|IVUS-guided PCI|Performing intravascular ultrasound before or/and after percutaneous intervention
15847435|NCT04063345|Procedure|Angiography-guided PCI|Performing percutaneous intervention without intravascular ultrasound guidance
15847436|NCT04063319|Other|High-fidelity simulation|The set up in the high-fidelity simulation intervention is a deteriorating patient scenario.
15847437|NCT04063306|Other|none of intervention was given|this is an observational survey and no intervention is given
15847438|NCT04063293|Biological|Platelet Rich Plasma|PRP injection into tha anal canal in patients underwent low anterior resection for rectal cancer
15847439|NCT04063267|Device|E cigarettes|Participants will be encouraged to substitute e-cigarettes for combustible cigarettes in order to reduce nicotine withdrawal symptoms
15847440|NCT04063267|Other|Nicotine Replacement Therapy|Nicotine patches and gum to last them the first week based on their baseline recorded smoking. Participants will be advised to use both a 21 mg nicotine patch and 4 mg nicotine for cravings.
15847441|NCT04063254|Radiation|Stereotactic Radiotherapy|"High Dose (Arm A): Stereotactic radiotherapy with 12 or 16 Gy in single fraction using intensity modulated radiotherapy or volumetric modulated arc therapy (VMAT or RapidArc).
~Standard-dose (Arm B): Stereotactic radiotherapy with 8 or 10 Gy in single fraction using intensity modulated radiotherapy or volumetric modulated arc therapy (VMAT or RapidArc)."
15847442|NCT04063241|Other|Health Literacy-Informed Discharge Instructions|Web-based disease-specific instruction sheets that will be printed with the research team's help. Providers will reference these instructions as they perform discharge counseling and will give parents a copy of the instructions to refer to at home.
15847443|NCT04063241|Other|Provider Training|20-minute long provider training session, including information about health literacy, advanced counseling strategies, results of prior studies, and pre-implementation data.
15847444|NCT04063228|Other|Simple Skill Group|will practice the following skills as needed: bed mobility, transfer, walking, and stairs.
15847445|NCT04063228|Other|Complex Skill Group|The program will consist of interventions at the impairments level with an emphasis on core strengthening, functional lower extremity strengthening, balance and endurance training, and at the skill acquisition level. Participants will learn pre-running skills (walking, stairs with handrail, walking backward, walking over obstacles, walking on toes, stairs without handrail, bounding), running skills (force generation in vertical plane: hopping, alternate hopping, running in place in gravity minimized position and against gravity; force generation in horizontal plane: bounding, alternate bounding, open chain movement for swing phase, running) and post running skills (running forward, backward, sideways, skipping, hopping).
15847446|NCT04063215|Biological|HB-adMSCs|Hope Biosciences autologous adipose-derived mesenchymal stem cells
15847447|NCT04063202|Other|Observation|The anonymous structured questionnaire will be self-administered by the participating students in the absence of their teachers in class-room settings.
15847450|NCT04063163|Drug|carboplatin and etoposide|chemotherapeutics
15847451|NCT04063163|Drug|placebo|placebo
15847452|NCT04063150|Biological|fIPV (0.1 mL) ID|Fractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.1 milliliter (mL) dose (fractional) by intradermal (ID) injection in lieu of the full 0.5 mL dose.
15847453|NCT04063150|Biological|fIPV (0.1mL) IM|Fractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.1 milliliter (mL) dose (fractional) by intramuscular (IM) injection in lieu of the full 0.5 mL dose.
15847454|NCT04063150|Biological|fIPV (0.2mL) IM|Fractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.2 milliliter (mL) dose (fractional) by intramuscular (IM) injection in lieu of the full 0.5 mL dose.
15847455|NCT04063150|Biological|IPV|Full dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.5 milliliter (mL) dose by intramuscular (IM) injection.
15847456|NCT04063137|Dietary Supplement|Anthocyanin fortified bread with beef patty (35% fat)|Bread is fortified at a 4% level using 25% (w/w) anthocyanin black rice extract. It is served with a beef patty (35% fat) to simulate a high-fat diet.
15847457|NCT04063124|Drug|Dasatinib + Quercetin|Intermittent D+Q administered for 2 days on/14 days off for 12 weeks (6 cycles)
15847458|NCT04063111|Device|vacuum assistant closure|Expose the open wound bed to negative pressure. This pressure removes edema or hemorrhage, mechanically pulls on the wound edges, decreases in wound surface area, improves circulation, and enhances proliferation of granulation tissue that filled the soft tissue defect.
15847459|NCT04063111|Device|CONVENTIONAL DRESSING|CONVENTIONAL DRESSING for wound of open fracture of tibia grade III B
15847460|NCT04063098|Other|Oral glucose tolerance test|Oral glucose tolerance test (OGTT) after a 72-hours standardized diet. OGTT will be performed 1 month prior to as well as 1, 3, 6, and 12 months after endoscopic sleeve gastroplasty
15847461|NCT04063085|Device|PROTAHERE Absorbable Adhesion Barrier|40 mg/ml (4%) cross-linked hyaluronan
15847462|NCT04063085|Device|Hyalobarrier Gel|Laparotomy: 40 mg/ml (4%) cross-linked hyaluronan Endoscopy: 30 mg/ml (3%) cross-linked hyaluronan
15847463|NCT04063085|Other|No treatment|No anti-adhesion agent applied
15847464|NCT04063085|Device|Seprafilm Adhesion Barrier|a hyaluronate carboxymethylcellulose-based bioresorbable membrane
15847465|NCT04063085|Device|Gynecare Interceed (TC7) Absorbable Adhesion Barrier|an oxidized regenerated cellulose absorbable membrane
15847466|NCT04063072|Procedure|ERAS protocol|In gynecological surgery, the ERAS protocol involves an accurate interview with the patient in the preoperative phase aimed at smoking and alcohol cessation, the reduction of preoperative fasting, the omission of intestinal preparation, the prophylaxis of thromboembolism, a correct antibiotic prophylaxis, the prevention of intraoperative hypothermia, prevention of volume overload, prevention of postoperative nausea and vomiting, very limited use of the nasogastric tube, early removal of the urinary catheter, multimodal analgesia to minimize opiate consumption, early postoperative mobilization and early post-operative feeding, to promote rapid recovery of gastro-intestinal functions.
15847467|NCT04063059|Behavioral|PRIDE counseling intervention|Step-by-Step program to create positive lifestyle change geared toward wellness and long term healthy living through group sessions and telephone counseling.
15847468|NCT04063046|Drug|General anesthesia|General anesthesia is induced with propofol (0.5-2mg / kg), remifentanil (4-8㎍ / kg / hr) and rocuronium (0.4 ~ 0.6 mg / kg) involving laryngeal mask(supraglottic airway device) insertion or endotracheal intubation. Anesthesia is maintained with 1.0-2.5% sevoflurane and remifentanil.
15847469|NCT04063046|Drug|Peripheral nerve block|ultrasound-guided popliteal sciatic nerve block is performed
15847470|NCT04063033|Drug|IV iron - Sodium Ferric Gluconate Complex|IV Iron will be administered 125 mg each day, to 3-5 days during hospitalisation.
15847471|NCT04063020|Behavioral|Psychological monitoring|"Discussions with the psychologist PhD student before and after every surgery times : 3 discussions.
~Before the first surgery (about 1 month before) Clinical interview Rorschach and TAT (Thematic Apperception Test) Drawing a person test Self Questionnaires : KIDSCREEN-27 and CDI Children's Depression Inventory- de Kovacs et Beck (1977)
~Before the second surgery (3 months later the first surgery) Clinical interview Drawing a person
~After the second surgery (15 months later the first surgery) Clinical interview Rorschach and TAT (Thematic Apperception Test) Drawing a person test Self Questionnaires : KIDSCREEN-27 and CDI Children's Depression Inventory- de Kovacs et Beck (1977)"
15847472|NCT04063007|Other|Ketogenic diet|The patients follow the ordinary treatment protocol for ketogenic diet
15847473|NCT04062994|Behavioral|Nudge to reduce intraoperative hypotension|Providers will be alerted if their patients are at high risk of hypotension or at increased risk of sequelae from hypotension. Intraoperatively, if patients have more than 10 minutes of hypotension an alert will be displayed on the screen.
15847474|NCT04062981|Drug|Carisbamate|An oral liquid formulation (20 mg/mL) of carisbamate (S-carisbamate)
15847475|NCT04062968|Other|Video education|"Prenatal screening video made by the Genetic Support Foundation and the Washington Department of Health, the 4.5 minute video How to Decide About Prenatal Genetic Testing, available at: https://www.geneticsupportfoundation.org/genetics-and-you/pregnancy-and-genetics/prenatal-genetic-testing-videos ."
15847476|NCT04062955|Dietary Supplement|Dietary Intervention|Receive dietary counseling
15847477|NCT04062955|Procedure|Dual X-ray Absorptiometry|Undergo DXA scan
15847478|NCT04062955|Other|Questionnaire Administration|Ancillary studies
15847479|NCT04062929|Behavioral|4-day physical activity program with behavioral intervention|Each program included 8-12 patients. During the four days, the participants had 4 collective sessions of educational information on PA and heart disease and 2 one-to-one sessions for promoting personal advice and experience on PA behavior. The participants had 6 sessions of PA and 2 food-counseling sessions.
15847480|NCT04062916|Other|BSGE pelvic pain questionnaire and VAS scores|Patients were evaluated using the BSGE pelvic pain questionnaire in terms of pre-operative and post-operative pain assessment in order to determine the effects of endometriosis surgery on the quality of life. The patients were asked to indicate their levels of dyspareunia, dysmenorrhea, and chronic pelvic pain on a VAS on the pelvic pain questionnaire.
15847481|NCT04062903|Behavioral|Immediate Appointment|The participant will meet with the MIND Cymru link worker and decide upon a course of action requiring the use of local services appropriate for the participant.
15848520|NCT04054557|Other|Educational Intervention|Receives time-specific reminders and messages
15847482|NCT04062903|Behavioral|Delayed appointment|After a period of delay (Control) The participant will meet with the MIND Cymru link worker and decide upon a course of action requiring the use of local services appropriate for the participant.
15847483|NCT04062890|Drug|Vigabatrin Pill|Oral Vigabatrin Pill
15847484|NCT04062890|Drug|Placebo oral tablet|Oral Placebo Pill
15847485|NCT04062864|Device|Pupil size|Measures the diameter of pupil before and after painful stimuli
15847486|NCT04062851|Other|No Gastric residual volume monitoring|Gastric residual volumes will not be monitored
15847487|NCT04062838|Drug|Dextrose 50|As above
15847488|NCT04062799|Other|no intervention|It is an observationa study. There is no intervention.
15847489|NCT04062786|Other|Pmsf-PVC gradient measurement|implementation of standard standard hemodynamic monitorin
15847490|NCT04062773|Behavioral|TRF|time restricted feeding group
15847491|NCT04062773|Behavioral|Normal timing of food intake|no time restricted feeding
15847492|NCT04062760|Drug|Standard diuretic therapy|The patients in this arm will be randomized to receiving oral furosemide in 2 daily divided doses at twice the intravenous dose administered during the past 24 hours. Unless serum potassium value is higher than 5 mmol/L, oral spironolactone or potassium canrenoate will be added; dose will be established based on serum creatinine value.
15847493|NCT04062760|Drug|Early sequential nephron blockade|"After 24-72 hours of an algorithm-based treatment with high-dose intravenous furosemide started at the time of hospital admission, the patients in this arm will be randomized to receiving:
~oral furosemide in 2 daily divided doses at a dose equivalent to that administered intravenously during the past 24 hours
~metolazone at a dose based on serum creatinine value
~acetazolamide at a dose based on serum creatinine value
~spironolactone or potassium canrenoate (unless serum potassium value is higher than 5 mmol/L); dose will be established based on serum creatinine value"
15847494|NCT04062747|Device|I-gel|After standard anesthesia i-Gel was placed into the patient
15847495|NCT04062747|Device|Ambu aura i|After standard anesthesia ambu aura was placed into the patient
15847496|NCT04062721|Drug|Chemotherapy|Chemotherapy (at the investigator's choice) for ≥ 2 months before RFA (with controlled disease) and resumed 4-6 weeks after RFA to achieve 6-month total duration.
15847497|NCT04062721|Procedure|Radiofrequency ablation (RFA)|Complete macroscopic ablation by RFA.
15847498|NCT04062721|Drug|In situ immunotherapy|Hydrogel combining TLR or NOD2 agonist and GM-CSF will be injected in 1, 2 or 3 distinct lesions after RFA.
15847499|NCT04062708|Drug|Durvalumab|"Preoperative Treatment:
~Non-squamous NSCLC: durvalumab 1125 mg, followed by pemetrexed 500 mg/m2 IV with cisplatin 75 mg/m2 IV, every 3 weeks, for 4 cycles
~Squamous NSCLC: durvalumab 1125 mg, followed by docetaxel 75 mg/m2 IV with cisplatin 75 mg/m2 IV, every 3 weeks, for 4 cycles
~Adjuvant Therapy:
~• 1-6 weeks after completion of radiotherapy, durvalumab 1500 mg IV every 4 weeks will be administered for 13 cycles."
15847500|NCT04062708|Procedure|Surgery|Patients will be re-evaluated following preoperative treatment to assess if patient is still medically fit to withstand surgery. Eligible patients will then undergo lobectomy, bilobectomy, sleeve lobectomy or other extended resection, or a pneumonectomy will be performed at the discretion of the attending thoracic surgeon.
15847501|NCT04062708|Radiation|Radiotherapy|4-10 weeks after surgery, patients will receive 54 Gy of radiotherapy with single daily fractions.
15847502|NCT04062695|Drug|Tofacitinib 5 MG Oral Tablet [Xeljanz]|verum tablets
15847503|NCT04062695|Drug|Placebo oral tablet|tablets containing placebo
15847504|NCT04062682|Behavioral|Healthy Diet|Receive counseling to meet guidelines for healthy dietary patterns
15847505|NCT04062669|Biological|Low dose formulation of RG SAM (CNE) vaccine (GSK3903133A)|Subjects in the low dose (Ld-) RG SAM (CNE) group will receive 2 doses of RG SAM (CNE) low dose formulation, administered intramuscularlyat Days 1 and 61.
15847506|NCT04062669|Biological|Medium dose formulation of RG SAM (CNE) vaccine (GSK3903133A)|Subjects in the medium dose (Md-) RG SAM (CNE) group will receive 1 doses of RG SAM (CNE) medium dose formulation, administered intramuscularly at Day 1.
15847507|NCT04062669|Biological|Lower dose formulation of RG SAM (CNE) vaccine (GSK3903133A)|Subjects in the Lower dose (Lrd-) RG SAM (CNE) group will receive 2 doses of RG SAM (CNE) lower dose formulation, administered intramuscularly, according to a 0, 2-month schedule (i.e. at Days 1 and 61)
15847508|NCT04062669|Biological|Lowest dose formulation of RG SAM (CNE) vaccine (GSK3903133A)|Subjects in the Lowest dose (Ltd-) RG SAM (CNE) group will receive 2 doses of RG SAM (CNE) lowest dose formulation, administered intramuscularly, according to a 0, 2-month schedule (i.e. at Days 1 and 61)
15847509|NCT04062669|Drug|Saline Placebo|Subjects in the Saline Placebo group will receive 2 doses of saline Placebo, administered intramuscularly Day 1 and 61.
15847510|NCT04062669|Biological|RabAvert|Subjects in the RabAvert Group will receive 2 doses of RabAvert vaccine, administered intramuscularly, at Days 1 and 61.
15847511|NCT04062656|Drug|Nivolumab|Nivolumab 240mg administered IV over 30 minutes Nivolumab 480mg should be administered IV over 60 minutes
15847512|NCT04062656|Drug|relatlimab|relatlimab (80mg flat dose) administered IV over 60 min
15847513|NCT04062656|Drug|Oxaliplatin|Oxaliplatin 85mg/m² IV over 1 h
15847514|NCT04062656|Drug|Docetaxel|Docetaxel 50mg/m² IV over 1 h
15847515|NCT04062656|Drug|5-Fluorouracil (5-FU)|5-fluorouracil 2600mg/m² IV over 24h
15847516|NCT04062656|Drug|Folic acid (FA)|Folic acid 200mg/m² IV over 30 min
15847517|NCT04062643|Diagnostic Test|Obesity assessment|Body mass index (BMI (kg/m2) was calculated from measurements of weight to the nearest kg and height
15847518|NCT04062630|Device|iFuse 3-D in Bedrock Configuration|Procedure in which 3 or more spinal segments are fused and concomitant pelvic fixation is performed, additionally iFuse 3-D implants are placed in a trajectory parallel to the S2AI screws.
15847519|NCT04062630|Procedure|Multilevel Lumbar Fusion surgery|Procedure in which 3 or more spinal segments are fused and concomitant pelvic fixation is performed.
15847520|NCT04062604|Other|surgery|surgical treatment of femur fracture, hip and knee alloplasty, knee arthroscopy
15847521|NCT04062591|Drug|Piroxicam group|patients will receive 0.4 mg/kg piroxicam IM
15847522|NCT04062591|Drug|Placebo|saline IM in the same dose of piroxicam
15847558|NCT04062305|Behavioral|Hand Function Test|Complete tasks that test grip strength, pinch strength, and ability to use and feel with hands
15847559|NCT04062305|Procedure|Navigated Transcranial Magnetic Stimulation|Undergo nTMS
15847523|NCT04062578|Behavioral|Physiotherapy program of lumbopelvic stabilization and strengthening of the hip region musculature|The intervention program will begin in August, along with the 2019/2020 season, and will finish at the end of the first round (5-6 months). It will be applied to CD Oliver players in three weekly sessions: preventive force, compensatory force and physiotherapy attention. During this intervention period, the SD Huesca players, control group, continued with their usual training program. They will not implement any physiotherapy program like the designed one for the study.
15847524|NCT04062565|Drug|Treprostinil Injectable Product|Injection
15847525|NCT04062565|Drug|Riociguat Pill|Tablet
15847526|NCT04062552|Other|Behavioral, Psychological or Informational Intervention|Receive ENABLE palliative care information
15847527|NCT04062552|Other|Educational Intervention|Participate in VLC group-based learning sessions
15847528|NCT04062552|Other|Educational Intervention|Participate in consultation with ENABLE/TA expert
15847529|NCT04062552|Procedure|Medical Examination|Undergo palliative care assessment
15847530|NCT04062552|Other|Quality-of-Life Assessment|Ancillary studies
15847531|NCT04062552|Other|Survey Administration|Complete surveys
15847532|NCT04062552|Behavioral|Telephone-Based Intervention|Receive monthly phone calls
15847533|NCT04062539|Device|Sentinel and Spider|Dual filter and single filter
15847534|NCT04062526|Drug|[18F]NOS|[18F]NOS is an investigational radiotracer which each subject will have one [18F]NOS positron emission tomography/computed tomography (PET/CT) scan performed.
15847535|NCT04062513|Other|Olfactive stimulation intervention with familiarization|The intervention consists of placing a pad immersed with breast milk near the preterm infant's nose during heel prick. For the familiarization stage, infants were familiarized with the odor of their mothers' milk for 9 hours before heel prick.
15847536|NCT04062513|Other|Olfactive stimulation intervention|The intervention consists of placing a pad immersed with breast milk near the preterm infant's nose during heel prick.
15847537|NCT04062513|Other|Standard care|Preterm infants will receive sucrose during heel prick.
15847538|NCT04062500|Other|Mortality and Rehospitalization rate|Mortality and Re-hospitalization of acute decompensated heart failure
15847539|NCT04062487|Device|Mixed Reality technology|combine image with real body
15847540|NCT04062474|Procedure|Epidural Intervention with TNF-α inhibitor|Epidural administration with TNF-α inhibitor
15847541|NCT04062461|Other|Multifaceted strategy based on sending text messages(SMS)|"multifaceted strategy based on sending text messages(SMS) to patients with heart failure.
~Press educational content on heart failure for the patient (symptoms of the disease, healthy habits for HF, warning signs for severity).
~The text messages are about how the patient should take your drugs (evem diuretics), measure blood pressure and weight in Kg, and about signals and symptoms (shorthbreathness during the night), and about how important is practice physical exercises and don't drink alcohol."
15847542|NCT04062461|Other|Usual outpatient care|Educational content on heart failure for the patient (symptoms of the disease, healthy habits for HF, warning signs for severity)
15847543|NCT04062448|Drug|Ibrutinib|Ibrutinib 420 mg will be administered orally.
15847544|NCT04062448|Drug|Rituximab|Rituximab 375 mg/m^2 will be administered intravenously.
15847545|NCT04062435|Drug|Drop application in the inferior fornix|See Arms
15847546|NCT04062435|Drug|Drop application on the cornea|See Arms
15847547|NCT04062396|Device|Eurosets REMOWELL 2 oxygenator|The main characteristic of REMOWELL 2 oxygenator is the presence of a filtration system for extracavitary inlet. Multilayer cascade filtration and supernatant separator leads to lipid-leukocytes depletion
15847548|NCT04062396|Device|LivaNova INSPIRE oxygenator|INSPIRE oxygenator has no filtration system for extracavitary inlet
15847549|NCT04062383|Behavioral|Positive Psychology + Motivational Interviewing|For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting.
15847550|NCT04062370|Drug|Ranibizumab|Patients will receive intravitreal injection of Ranibizumab 0.5 mg (1+PRN or 3+PRN) according to the study until month 6. Then, patients will received Ranibizumab PRN only or laser photocoagulation with Ranibizumab PRN after month 6.
15847551|NCT04062370|Device|laser photocoagulation|After month 6, patients will received Ranibizumab PRN only or laser photocoagulation with Ranibizumab PRN according the re-randomization at month 6.
15847552|NCT04062357|Drug|Lidocaine 5% spray|Group 1 (n₌75); was given on demand lidocaine 5% spray for 8 weeks (One to two applications (1-2 ml) of lidocaine 5% sprays; contain 5 -10 mg of lidocaine, in a metered dose aerosol-delivery system).
15847553|NCT04062357|Other|Placebo|Group 2 (n₌75); was given placebo in form on demand alcohol spray for 8 weeks.
15847554|NCT04062344|Other|Swab|Rectal swab before and after the drug provocation testing
15847555|NCT04062331|Device|Transcranial Magnetic Stimulation (TMS)|"By means of the magnetic stimulator we induce a cerebral electric current that is able to obtain a motor potential in the first dorsal interosseous bone of the left hand.
~The intervention procedure consists of two steps: First step: Obtaining the Motor Evoked Threshold at Rest: Each patient, regardless of to the group to which they belong will have his/her threshold evoked motor calculated at rest, by stimulation of the right motor cortex, evoking electromyographic responses in the contralateral muscles. Second step: Administration of TMS: To calculate the motive threshold as the percentage of the same to which the treatment will have to be applied, a device equipped with a coil. The treatment will be administered for 5 consecutive days, with 3 weeks of rest, between each stimulation. To complete a treatment period of 14 months. The stimulation with TMS will be carried out every day in the same time slot for 5 consecutive days every 4 weeks, during a period of 14 months."
15847556|NCT04062331|Drug|Placebos|Administration of Transcranial Magnetic Stimulation at 0 Hz (the patient will be only under drug standar therapy)
15847557|NCT04062318|Device|Online active TMS|"One single pulse or triple pulse train (3 pulses, 20ms inter-pulse interval) of TMS will be delivered per trial (at least 5 seconds apart) online, or during the tactile detection task, at less than or equal to 80% active motor threshold."
15847562|NCT04062279|Diagnostic Test|serum alpha synuclein autoantibodies, motor and non motor scales|measuring serum alpha synuclein autoantibodies by ELIZA at baseline assessment
15847565|NCT04062253|Diagnostic Test|HCV rapid test|Individuals who test positive for either HIV or HCV are offered PCR (polymerase chain reaction) testing with the xpert technology. Patients with a confirmed active infection are offered delivery and are taken into hospital.
15847566|NCT04062240|Device|BIS sensor|BIS sensors will be labeled L and R. The degree of variability between the concurrent use of the sensors will be assessed .
15847567|NCT04062214|Behavioral|SBIRT-PM|SBIRT-PM involves an initial telephone-delivered session followed by up to three calls to Veterans in a 12-week period to support Veteran engagement in multi-modal non-pharmacological pain care and to motivate those who misuse substances to change this problematic behavior. SBIRT-PM also includes coordination between the SBIRT-PM clinicians and the PACT nurse case manager after the initial session to support these patient outcomes.
15847568|NCT04062201|Drug|Bedaquiline Oral Tablet|Days 1-14: 400mg once daily for two weeks and then 200mg three times per week for weeks 3-24
15847569|NCT04062201|Drug|Linezolid Oral Tablet|Weight Group 30-33kg: 300mg daily for 24 weeks; Weight Group 33kg or more: 600mg daily for 24 weeks. Dose reduction, interruption or permanent discontinuation of this drug is allowed per protocol.
15847570|NCT04062201|Drug|Delamanid in Oral Dosage Form|100mg twice daily for 8 weeks and then 200mg daily for 16 weeks
15847571|NCT04062201|Drug|Clofazimine Oral Product|100mg daily (duration dependent on fluoroquinolone sensitivity results) duration may be up to 24 weeks
15847572|NCT04062201|Drug|Levofloxacin Oral Tablet|Weight Group 30-33kg: 15mg/kg daily; Weight Group 33-50kg: 750mg daily; Weight Group more than 50kg: 1000mg daily. Duration dependent on fluoroquinolone sensitivity results- duration may be up to 24 weeks
15847573|NCT04062201|Drug|Isoniazid Oral Product|At 10 mg/kg to a maximum dose of 600mg for 16 weeks. Weight Group 30-33kg: 300mg daily for 16 weeks; Weight Group 33-50kg: 400mg daily for 16 weeks; Weight Group more than 50kg: 600mg daily for 16 weeks If the smear is positive at week 16, Isoniazid must be extended to 24 weeks
15847574|NCT04062201|Drug|Ethambutol Oral Product|Weight Group 30-33kg: 800mg daily for 40 weeks; Weight Group 33-50kg: 800mg daily for 40 weeks; Weight Group more than 50kg: 1200mg daily for 40 weeks
15847575|NCT04062201|Drug|Pyrazinamide Oral Product|Weight Group 30-33kg: 1000mg daily for 40 weeks; Weight Group 33-50kg: 1500mg daily for 40 weeks; Weight Group more than 50kg: 2000mg daily for 40 weeks
15847576|NCT04062201|Drug|Linezolid Oral Tablet|Weight Group 30-33kg: 300mg daily for 8 weeks; Weight Group more than 33kg: 600mg daily for 8 weeks;
15847577|NCT04062201|Drug|Clofazimine Oral Product|100mg for 40 weeks
15847578|NCT04062201|Drug|Levofloxacin Oral Tablet|Weight Group 30-33kg: 15mg/kg daily for 40 weeks; Weight Group 33-50kg: 750mg daily for 40 weeks; Weight Group more than 50kg: 1000mg daily for 40 weeks
15847579|NCT04062188|Other|Telephone Interview Form|Telephone Interview Form is an original simple questionnaire developed based on the combination of Barthel Index questionnaire and simplified modified Rankin Scale questionnaire with internal rules.
15847580|NCT04062175|Drug|cephalosporin|72 women will receive single antibiotic chemotherapy(Cefazolin) 2 gm iv within 30 minutes before skin incision
15847581|NCT04062175|Drug|Azithromycin Tablets|72 women will receive combined antibiotic chemotherapy azithromycin(Azrolid) 1 gm single oral dose 2 hours before cesarean delivery +cephalosporin(Cefazolin) 2 gm iv within 30 minutes before skin incision
15847582|NCT04062162|Behavioral|Walking football training|Intervention will involve 3 sessions per week of a structured and supervised walking football program over 16 weeks. Each session will include a warm-up, followed by the practice of specific exercises where specific technical skills (pass, dribble, shot), motor skills (agility, coordination, balance) and physical fitness (cardiorespiratory and musculoskeletal capacity) will be enhanced, ending with a structured game (7x7) of walking football and a cooldown.
15847583|NCT04062149|Other|single leg stance treatment|SLS treatment following the neurodevelopmental treatment (NDT). SLS is the ability of one limb to support the body's weight in a standing position. In gait it is the foot being in contact with the ground whilst the body passes over it and this stance phase of gait accounts for 60% of the gait cycle. The treatment approach of NDT has been chosen as this is the most common physiotherapy treatment option in the UK and is the most common option in the studies above. NDT is a problem-solving approach to the assessment and treatment of individuals with disturbances of function, movement and postural control due to a lesion of the central nervous system and provides an outline of the treatment required to achieve SLS which will form the basis of the intervention of this study.
15847584|NCT04062149|Other|Usual physiotherapy|Individualised physiotherapy treatment approach, as per standard protocol, but it will not work specifically on SLS. Will be based on the neuro-developmental technique.
15847585|NCT04062136|Combination Product|stem cell transplantation|Transplantation of umbilical cord mesenchymal stem cells
15847586|NCT04062123|Drug|Dexmedetomidine|Subjects in this group will receive a intravenous infusion of this drug, during a portion of the study. Dose will be targeted to a brain effect site concentration of 0.15 ng/ml, using pharmacokinetic modelling within the STANPUMP algorithm that accounts for subject's age, gender, height, & weight.
15847587|NCT04062123|Drug|Propofol|Subjects in this group will receive a intravenous infusion of this drug, during a portion of the study. Dose will be targeted to a brain effect site concentration of 0.7 mcg/ml, using pharmacokinetic modelling within the STANPUMP algorithm that accounts for subject's age, gender, height, & weight.
15847588|NCT04062123|Drug|Fentanyl|Subjects in this group will receive a intravenous infusion of this drug, during a portion of the study. Dose will be targeted to a brain effect site concentration of 0.9 ng/ml, using pharmacokinetic modelling within the STANPUMP algorithm that accounts for subject's age, gender, height, & weight.
15847589|NCT04062123|Device|Peripheral Nerve Stimulation|Experimental acute pain stimulus will be delivered using a nerve stimulator. These painful shocks will be paired randomly with some of the experimental cues.
15847590|NCT04062123|Drug|Placebo|Crystalloid IV solution will be infused, with no active drug.
15847591|NCT04062110|Device|plaster cast|Closed Reduction of Fracture and Application of Plaster Cast
15847592|NCT04062097|Drug|Dabigatran Etexilate Oral Capsule [Pradaxa]|Dabigatran is the most frequently used direct thrombin inhibitor in secondary stroke prevention in patients with atrial fibrillation.
15847593|NCT04062097|Drug|Idarucizumab 2.5 GM/50 ML Intravenous Solution [PRAXBIND]|Idarucizumab is the current standard therapy in patients with intracranial bleeding under anticoagulation with dabigatran.
15847594|NCT04062097|Drug|Vitamin K antagonist|This drug group includes the active substances phenprocoumon and warfarin.
15847595|NCT04062084|Device|Multifunctional Cataract-assisted Retractor|Multifunctional Cataract-assisted retractor operation for cataract with subluxation of lens
15847596|NCT04062071|Other|no intervention|no intervention
15847597|NCT04062058|Radiation|SIB-IMRT|45Gy in 25 fractions using intensity-modulated radiotherapy to the radiation target
15847598|NCT04062058|Drug|S-1|40-60mg/m2(according to patient's body surface area), orally twice daily every weekday concurrently with radiotherapy treatment
15847599|NCT04062058|Drug|SOX|SOX (S-1: 40~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle)
15847600|NCT04062058|Procedure|Surgery|Surgery, preferred D2 lymphadenectomy
15847601|NCT04062045|Drug|Ropivacaine Hcl 0.2% Inj Vil 10Ml|Group A will receive the medicine through the erector spinae catheter.
15847602|NCT04062045|Drug|Saline 0.9%|Group B will receive Saline 0,9% through the erector spinae catheter.
15847603|NCT04062032|Drug|Aspirin 81 mg|ASA 81mg taken daily
15847604|NCT04062032|Drug|Aspirin 325mg|ASA 325mg taken daily
15847605|NCT04062019|Drug|Interleukin-2|low dose interleukin-2 injected subcutaneously, at a dose of 1 x 10~6 IU/m2 once every other day, for 3 months.
15847606|NCT04062006|Drug|Interleukin-2|low dose interleukin-2 injected subcutaneously, at a dose of 1 x 10~6 IU/m2 five days per week for 4 weeks (day1-5, 8-12, 15-19, 22-26) and then once a week for 8 weeks (day33, 40, 47, 54, 61, 68, 75, 82).
15847607|NCT04061993|Procedure|Strength and Sensory-Motor Training|Early postoperative strength and sensory-motor training after total hip arthroplasty. Training consists of: hip muscles strengthening (focusing on abductors); hip and pelvic stabilization exercises; ankle and knee muscles strengthening (better dissipation of impact forces and femoral inner rotation control); trunk muscles strengthening (stabilization of pelvis and lumbar spine and reduction of local loading).
15847608|NCT04061993|Procedure|Current Standard Physiotherapy|Mobilisation using a walking aid (usually two crutches, rarely a walker), deep vein thrombosis (DVT) prevention exercises, lower limb range of motion exercises and isometric strengthening program
15847609|NCT04061980|Drug|Binimetinib|Given PO
15847610|NCT04061980|Drug|Encorafenib|Given PO
15847611|NCT04061980|Biological|Nivolumab|Given IV
15847612|NCT04061967|Other|Sending of screening summon.|A Cobas PCR Female swab sample packet will be sent. Response rates will be measured.
15847613|NCT04061954|Behavioral|Comprehensive family intervention including individual sessions of FORNET|"Families in the intervention group received:
~Parents participate in a group intervention once a week for about 20 weeks, including psychoeducation on mental health and drug and alcohol abuse, anger management, family planning, parenting skills, communication skills, and dealing with couples conflicts
~Family visits to address topics as family cohesion, intra-familial communication and psychological basic need of children
~Trauma-focused therapies (FORNET), which aim also at reducing violent behaviour
~Parents receive training regarding agriculture and micro credit projects, and financial assistance
~One child per family receives a social skill training group preparing them for returning to school
~Access to schools and school material
~If needed medical assistance is provided
~If needed legal assistance is provided"
15847614|NCT04061941|Behavioral|Cognitive Assessment|Assessment on cognitive dysfunction using standardised cognitive tests
15847615|NCT04061928|Drug|PD-1|2 times PD-1 (240mg) combined with preoperative chemoradiotherapy，then another 2 times PD-1 before operation. 4 times PD-1 combined with postoperative chemotherapy.
15847616|NCT04061915|Behavioral|Infographic Intervention|A HIV self-testing infographic that utilizes a simplicity model collaboratively designed by a leadership group of HIV community members
15847617|NCT04061915|Behavioral|Paper-based HIV self-testing information|The online control arm will consist of paper-based, HIV self-testing information that the emerging adults will read.
15847618|NCT04061902|Other|Participation with enhanced patient perioperative information|Improved information and dialogue about the care goals in the fast track protocol.
15847619|NCT04061889|Other|intervention name is not applicable|Another intervention is not applicable either, due to the observational study design
15847620|NCT04061876|Drug|Ruxolitinib|Participants began oral administration of ruxolitinib at 5 mg QD;Methylprednisolone: 1mg/kg/d , iv or iv gtt for at least 5 days, then taper according to the clinical response.
15847621|NCT04061876|Drug|Corticosteroid|Methylprednisolone: 2mg/kg/d , iv or iv gtt for at least 3 days, then taper according to the clinical response. 1mg/kg/d , iv or iv gtt for at least 5 days, then taper according to the clinical response.
15847622|NCT04061863|Drug|Nivolumab|Nivolumab 360mg on D1 every 3 weeks Eribulin 1.4mg/m2 on D1, 8 every 3 weeks
15847623|NCT04061837|Device|MitralStitch|With transesophageal echocardiographic guidance,implanting ePTFE sutures as artificial chordae or ege-to-ege repair using MitralStitch Mitral Valve Repair System
15847624|NCT04061824|Drug|Olostar Tab (olmesartan/rosuvastatin FDC(fixed dose combination))|In intervention group, patients had a pill of fixed-dose combination of Olmesartan medoxomil and Rosuvastatin, rather taking separated two pills.
15847625|NCT04061824|Drug|Two separated drugs(ARB(Angiotensin Ⅱ receptor blocker) and statin)|In control group, patients had two separated pills for hypertension and dyslipidemia. One of ARBs(Valsartan, Olmesartan, Candesartan, Telmisartan, Fimasartan, Losartan and Irbesartan) and one of statins(Rosuvastatin, Atorvastatin, Pitavastatin, Simvastatin, Pravastatin, Fluvastatin and Atorvastatin/Ezetimibe).
15847626|NCT04061811|Diagnostic Test|Diagnostic biomarker study|Comparing circulating concentrations of NT-proBNP, GDF15, and neprilysin (NEP) along with NEP activity in patients with and without HF, as diagnosed by clinical parameters and post-dialysis echocardiography.
15847681|NCT04061330|Drug|Ketamine|Initial bolus of ketamine 0.3 mg/kg IV (maximum 30 mg) followed by ketamine infusion of 0.25mg/kg/hr (maximum 25mg/kg/hr) for 6 hours or until patient leaves the emergency department (ED),whichever occurs first.
15847682|NCT04061330|Drug|Morphine|Bolus doses of morphine 0.1 mg/kg (maximum 8 mg) intravenously every 2 hours for 6 hours or until patient leaves the ED, whichever occurs first.
15847924|NCT04059367|Drug|Cocktail of 5 already approved drugs|5 medicines as tablets, capsules or syrup to be taken with water on Day 1 and Day 78 of the study
15847627|NCT04061798|Drug|ACT guided heparinization|"If the ACT is <180 sec., an additional dose of heparin of 60 IU/kg is administered. If the ACT is 180-200 sec., 30 IU/kg.
~If the ACT is >200 sec., no extra heparin is given. 5 min. after every administration of heparin the ACT is measured. If the ACT is >200 sec, the next ACT measurement is performed every 30 min., until the end of the procedure or until new heparin administration is required. After each new dose of heparin, an ACT measurement is performed after 5 min. and the above- described protocol of ACT measurements will be repeated. After re-establishing blood flow and removing all clamps, the ACT is measured.
~If the ACT at closure is 200-250 sec., 2500 IU of protamine should be administered. If >250 sec., 5000 IU protamine. If 180-200 sec., 1000 IU protamine. 5 min. after the administration of protamine, the ACT is measured. The ACT should preferably be below 180 sec. If the ACT is still more than 200 sec., protamine should be administered again."
15847628|NCT04061798|Drug|5 000 IU of heparin|"A single dose of 5 000 IU of heparin is given 3-5 min before clamping of the aorta. No ACT measurements are performed, except for one ACT measurement after re-establishing blood flow and removing all clamps. Only on clarified indications extra doses of heparin or protamine are permitted, at the discretion of the attending vascular surgeon. Indications could be clot formation intravascular or in a prosthesis, excessive bleeding or prolonged operation duration. Deviations from protocol should be clearly stated with reasoning in the operative report.
~If the ACT at closure is between 200 and 250 s, 2500 IU protamine should be administered. If the ACT is higher than 250 s, 5000 IU protamine should be administered. If the ACT is between 180 and 200 s, 1000 IU protamine should be administered. Five minutes after the administration of protamine, the ACT is measured. The ACT should preferably be below 180 s. If the ACT is still more than 200 s, protamine should be administered again."
15847629|NCT04061785|Other|Judo4Balance - 12 week judo inspired exercise program|12 weeks x 45 minute judo inspired exercise in lead by instructor in a group setting.
15847630|NCT04061772|Drug|Bortezomib|Bortezomib injection
15847631|NCT04061772|Drug|Etoposide|Etoposide injection
15847632|NCT04061772|Drug|Cyclophosphamide|Cyclophosphamide injection
15847633|NCT04061772|Drug|Pharmorubicin|Pharmorubicin injection
15847634|NCT04061772|Drug|Prednisone|Prednisone tablet
15847635|NCT04061759|Other|Effectiveness of four physical therapy approaches (soft tissue manual therapy, Kinesio® Taping techniques, stabilization exercises and reflex therapy) for treating lumbar disc pathologies.|Visual analog scale (VAS) scores for pain intensity, goniometric measurements for the range of motion and hamstring flexibility, the sit and reach test for flexibility, an isokinetic evaluation for strength at 60°/sec, and a side-plank position test for trunk stabilization were measured. The functional status was evaluated with the Oswestry Disability Index. All groups were assessed at the beginning, after a four-week treatment and four weeks of follow-up.
15847636|NCT04061746|Biological|Mesenchymal Stem Cells (MSCs)|Patients in Group A will receive a single MSCs infusion
15847637|NCT04061746|Other|Placebo Infusion (Plasmalyte A with 0.5% human serum albumin)|Patients in Group B will receive a single infusion of placebo (Plasmalyte A with 0.5% human serum albumin)
15847638|NCT04061733|Device|Hydrogel injection|Hydrogel injection
15847639|NCT04061720|Behavioral|Enhanced Chronic Care|Enhanced Chronic Care involves four chronic care calls per year. Enhanced Chronic Care is designed to help participants explore their goals and concerns with regard to smoking, engage in a nondirective, supportive, motivational interventions, and provide information about evidence-based smoking treatment available to them and ways to initiate treatment (i.e., warm hand-off from a clinical provider).
15847640|NCT04061720|Behavioral|Standard Care|Standard Care involves one call per year. During the Standard Care call, participants will be encouraged to quit smoking, reminded of the cessation treatment available to them, and provided with a number to call should they become interested in treatment.
15847641|NCT04061694|Procedure|Immediate loading, fully guided surgery and 3D printed restoration|Fully guided surgery installation of single dental implants. 3D printed restorations that were immediate loaded.
15847642|NCT04061694|Procedure|Immediate loading|Only subjected to immediate loading. Conventional procedure.
15847643|NCT04061681|Behavioral|Behavioral Intervention (BIPAMS)|This 16-week behavioral intervention teaches people the skills, techniques, and strategies based on Social Cognitive Theory of behavior change for modifying and self-regulating health behaviors, including physical activity. The behavioral intervention consists of two primary components, namely a dedicated Internet website and one-on-one video chats with a behavioral coach via SkypeTM.
15847644|NCT04061668|Other|single needle path PECS I and II block group|The probe is placed inferior to the clavicle . The US probe is placed below outer third of the clavicle showing pectoralis major and minor muscles and the thoraco- acromial artery then moved infero-laterally to locate fourth rib where pectoralis major and pectoralis minor muscles will be visualised . The probe is moved toward anterior axillary line till pectoralis minor and serratus anterior muscles ise identified at 4th rib at the level of thoraco-acromial artery , the needle is inserted in plane with the probe from caudal to cranial using an inclined manner, 15mL of bupivacaine is put into the potential space between pectoralis minor muscle and serratus muscle (PECS II) then it is withdrawn to inject another 15 ml of bupivacaine in the plane between pectoralis muscles . The block will be performed with needle introduced in-plane with the ultrasound probe, and the local anesthetic injection is visualised.
15847645|NCT04061668|Other|double needle path PECS I and II block group|The US probe will be initially placed below outer third of the clavicle after skin sterilization showing pectoralis major and minor muscles and the thoraco- acromial artery then moved inferolaterally to locate fourth rib where pectoralis major and pectoralis minor muscles will be visualised, then the needle will be inserted in plane with the probe and 15mL of bupivacaine 0.25% after negative aspiration will be put into the potential space between pectoralis muscles. In the second puncture , the US probe will be moved toward anterior axillary line till pectoralis minor and serratus anterior muscles will be identified at 4th rib at the level of thoraco-acromial artery then the needle will be inserted in plane with the probe from caudal to cranial in an inclined way, 15mL of bupivacaine 0.25% after negative aspiration will be put into the potential space between pectoralis minor muscle and serratus muscle (PECS II).
15847646|NCT04061655|Drug|Iron Isomaltoside 1000|Apatients (n= 40) received single dose intravenous infusions of iron isomaltoside 1000 mg over 15 min with a maximum single dose of 20 mg/kg.
15847647|NCT04061655|Other|placebo|Patients in the placebo group (n=40)received as a single-dose of saline (Natriumklorid 9 mg/ml; Fresenius Kabi, Copenhagen, Denmark) 100 ml infused over 15 min.
15847648|NCT04061642|Device|Clinical Decision Aid|The Clinical Decision Aid is a predictive model that takes as input individual patient characteristics, called 'features', which are inputted by the physician or by patient self-report, and outputs a list of all possible treatments, with each treatment associated with a predicted efficacy (likelihood to achieve response and likelihood to achieve remission, each expressed as a percentage). The treatments, which may include any approved treatment for depression, will be ordered by efficacy and presented to the physician. Lifestyle interventions, such as exercise or mindfulness, which have an evidence base, but do not require formal regulatory approval, will also be outputted. The system will additionally produce a side effect profile for each pharmacological treatment recommended, including known side effects, modified by a prediction about which side effects may be more likely for a given individual based on their individual characteristics.
15847649|NCT04061629|Device|Cuffed ETT|Cuffed endotracheal tube.
15847650|NCT04061616|Behavioral|PASIPD-Fr|Fill-out the PASIPD-Fr self questionaire twice (2 completions at a 2-week interval)
15847651|NCT04061603|Device|Adagio AF Cryoablation System (iCLAS™)|Endovascular ablation of the left and right atrium
15847652|NCT04061590|Drug|Cisplatin|Given IV
15847653|NCT04061590|Biological|Pembrolizumab|Given IV
15847654|NCT04061590|Drug|Pemetrexed|Given IV
15847655|NCT04061590|Drug|Pemetrexed Disodium|Given IV
15847656|NCT04061590|Procedure|Therapeutic Conventional Surgery|Undergo surgery
15847657|NCT04061577|Device|Transcranial Direct Current Stimulation (tDCS)|20 minutes of Cathodal tDCS after +/- before endovascular thrombectomy (EVT)
15847658|NCT04061564|Device|Vagal nerve stimulation|The participant will be administered electrical stimulation at a level specifically set to their comfort. This will be performed using a TENS machine device.
15847659|NCT04061551|Other|EC clinic support - whole of practice interventions delivery through nurse-led model|"The primary interventions will be delivered through a team of nurses, an evaluation team and practice support team that will be working with each of the services to improved Hepatitis C service delivery.
~The EC project team will predominantly be involved in working with providers and staff at EC sites to implement key interventions that have been collated into a Primary Care Practice Toolkit, which cover three domains; patient support, provider support and practice Support. The toolkit is designed to be an educational and implementation resource that the nursing team will support services to deliver.
~Patient support to reduce the impact of hepatitis C and other blood borne viruses
~Provider support to reduce the impact of hepatitis C and other blood borne viruses
~Practice support to reduce the impact of hepatitis C and other blood borne viruses"
15847660|NCT04061538|Dietary Supplement|zinc sulfate|zinc 20mg tablets
15847661|NCT04061538|Dietary Supplement|Placebo|Sugar pill manufactured to mimic zinc 20mg tablet
15847662|NCT04061525|Procedure|Percutaneous coronary intervention with FFR measurement and intracoronary ECG registration|Measurement of fractional flow reserve (FFR), registration of intracoronary ECG and radioscopic registration of wire tip movement in the main and in the side branch in the beginning, at the end and during every step of coronary bifurcation percutaneous intervention.
15847663|NCT04061512|Drug|Dexamethasone, cyclophosphamide, rituximab|DRC Arm (chemotherapy) consists of dexamethasone, cyclophosphamide and rituximab treatment
15847664|NCT04061512|Drug|Rituximab, ibrutinib|RI Arm (chemotherapy free) consists of rituximab and ibrutinib treatment
15847665|NCT04061473|Drug|Sitagliptin 100mg|"2 tablets of sitagliptin 100 mg.
~Standardized liquid meal Standardized liquid meal (200 ml) containing: 1,650 KJ, (394 kcal), carbohydrate 50%, protein 15%, fat 35% consisting of glucose (47.2 g + 2.8 g [U-13C6]-glucose), rapeseed oil (14.1 g), whey protein (15.2 g) and 1.5 g paracetamol."
15847666|NCT04061473|Drug|Empagliflozin 25 MG|2 tablets of empagliflozin 25 mg.
15847667|NCT04061473|Other|Placebo tablet|"2 placebo tablets.
~Standardized liquid meal Standardized liquid meal (200 ml) containing: 1,650 KJ, (394 kcal), carbohydrate 50%, protein 15%, fat 35% consisting of glucose (47.2 g + 2.8 g [U-13C6]-glucose), rapeseed oil (14.1 g), whey protein (15.2 g) and 1.5 g paracetamol."
15847668|NCT04061460|Procedure|mechanical plaque control|supra and sub gingival debridment ( plaque control)
15847669|NCT04061447|Drug|susceptibility-guided therapy|rabeprazole 20mg B.I.D, amoxicillin 1000mg B.I.D, and clarithromycin 500mg B.I.D for seven days.
15847670|NCT04061447|Drug|empirical clarithromycin-based triple therapy|The eradication regimen was based on the susceptibility results of gastric PCR. If clarithromycin was sensitive, the regimen contained rabeprazole 20mg B.I.D, amoxicillin 1000mg B.I.D, and clarithromycin 500mg B.I.D for seven days. If clarithromycin was resistant and levofloxacin was sensitive, the regimen was rabeprazole 20mg B.I.D, amoxicillin 1000mg B.I.D, and levofloxacin 500mg QD for seven days. If clarithromycin and levofloxacin were both resistant, the regimen was either reverse-hybrid therapy (rabeprazole 20mg B.I.D x 14 days, amoxicillin 1000mg B.I.D, x 14 days, clarithromycin 500mg B.I.D for 7 days, and metronidazole 500mg B.I.D for 7 days) or high dose dual therapy (rabeprazole 20mg Q.I.D and amoxicillin 1000mg Q.I.D for 14 days). Owing to this open design, either reverse-hybrid therapy or high dose dual therapy was chosen by doctors' preference.
15847671|NCT04061421|Drug|ASTX727|Taken by mouth daily during days 1-5 of every 28-day cycle.
15847672|NCT04061421|Drug|Itacitinib|Taken by mouth daily during each 28-day cycle
15847673|NCT04061408|Radiation|Fractionated stereotactic radiotherapy(FSRT)|3 to 5 fractions and 8Gy per fraction will be used for breast cancer patients with 1-10 brain metastases based on the lesion number and volume.
15847674|NCT04061395|Biological|Guselkumab|See study arm description.
15847675|NCT04061382|Procedure|Venepuncture|"One study visit will be conducted by research study staff and blood sampling will be carried out.
~Up to three follow-up visits will be conducted for a percentage of participants, where additional blood samples will be collected. The blood sample will initially focus on looking at population immunity to diphtheria, group C invasive meningococcal disease and SARS-CoV-2."
15847676|NCT04061382|Procedure|Oral fluid swab|Saliva sampling will be collected during the follow-up visits. This swab will be collected either by the participant or the participants parent/guardian on the day of the visit. The saliva sampling will primarily be analysed for SARS-CoV-2 antibodies.
15847677|NCT04061369|Other|Low fat meal|Meal consisting of conventional foods that is low (20% of energy) in fat calories.
15847678|NCT04061369|Other|Moderate fat meal|Meal consisting of conventional foods that is moderate (40% of energy) in fat calories.
15847838|NCT04060004|Other|Electrotherapy + therapeutic exercise|Standard care of neck pain.
15847683|NCT04061317|Other|Frailty Assessment|"We will use validated measures to determine existence of frailty prior to interventional cardiac procedures (PRISMA-7, Edmonton and FRIED Frailty Index). We will repeat the measures at 6 weeks and 6 months post procedure. We will also collect clinical data to assess any links between frailty and clinical outcomes.
~We are also keen to understand the effects of health-related quality of life on frailty and will be collecting generic data via the SF-36 and EQ5-D."
15847684|NCT04061304|Device|Repetitive Transcranial Magnetic Stimulation|A non-invasive method of brain stimulation.
15847685|NCT04061304|Device|Sham Transcranial Magnetic Stimulation|A device designed to look, sound, and feel like a real magnetic stimulation coil without actually stimulating the brain.
15847686|NCT04061278|Drug|4 cycles of Neoadjuvant Chemotherapy With Definitive Radiotherapy|4 Cycles of Neoadjuvant Chemotherapy With Definitive Radiotherapy, instead of Concurrent Chemoradiotherapy
15847687|NCT04061278|Drug|3 cycles of Neoadjuvant Chemotherapy With concurrent chemoradiotherapy|3 cycles of Neoadjuvant Chemotherapy With concurrent chemoradiotherapy, instead of definitive radiotherapy
15847688|NCT04061265|Drug|Articaine 4%/Epi 1:100000 Inj Cart 1.7Ml|Local anesthetic agent
15847689|NCT04061265|Drug|lidocaine hydrochloride 2% and epinephrine 1:100000|Local anesthetic agent
15847690|NCT04061252|Drug|KHK4827|brodalumab 210mg Q2W, SC
15847691|NCT04061252|Drug|Placebo|Q2W, SC
15847692|NCT04061239|Drug|CPX-351|CPX-351 is a liposomal formulation with a fixed 5:1 molar ratio of cytarabine and daunorubicin. It will be administered as a 90-minute intravenous infusion.
15847693|NCT04061239|Drug|Daunorubicin|Daunorubicin is commercially available as a powder for reconstitution in 20 mg vials. In this trial, daunorubicin should be administered as an IV infusion over 60 min.
15847694|NCT04061239|Drug|Cytarabine|Cytarabine is commercially available as vials/bottles for preparation of diluted infusion solution. Cytarabine will be administrated intravenously. In this trial, cytarabine is administered as a continuous infusion.
15847695|NCT04061239|Drug|Azacitidine|Azacitidine at 75mg/m² for 7 days. Patients should receive a minimum of 2 and up to 6 cycles.
15847697|NCT04061213|Diagnostic Test|Tc-99m-DPD scintigraphy|Myocardial scintigraphy
15847698|NCT04061200|Drug|Semaglutide, 1.34 mg/mL|After informed consent, subjects will be initiated on open-label empagliflozin 25 mg or maximal tolerated dosis once daily during a run-in period of 26 weeks. Participants will be randomized and up titrated to semaglutide 1.34 mg/ml or matching placebo once weekly during the following 26 weeks in a 1:1 ratio.
15847699|NCT04061200|Other|Placebo, 1,34 mg/mL|Participants will be randomised to either semaglutide or placebo as an add on treatment after 26 weeks of intervention with empagliflozin 25 mg.
15847700|NCT04061200|Drug|Empagliflozin 25 MG|After informed consent, subjects will be initiated on open-label empagliflozin 25 mg or maximal tolerated dosis once daily during a run-in period of 26 weeks.
15847701|NCT04061174|Other|Shoulder stabilization exercises|When participants are able to do the exercise 15 repetitions without difficulty, the exercise will be advanced by modifying or adding the weight.The exercises include chin tulk exercise, shoulder closed chain weight transfer, prone and iso-abdominal exercises, push-up exercise, lower trapezius muscle strengthening exercise, dead bug exercise, ball rolling on the wall, bench press with dumbbell and internal/external rotation (IR / ER) strengthening exercises
15847702|NCT04061174|Other|Office exercises training|Information will be given in a brochure that includes the appropriate chair height and work table, sitting position, distance between eyes and monitor, and table chair dimensions.approved and standardized office-based stretching and strengthening exercises will be given for workplaces
15847703|NCT04061161|Drug|Tiotropium Bromide|Participants will be double-blind randomized for Tiotropium or Placebo treatment for 6 weeks
15847704|NCT04061148|Device|NIRSIT|NIRSIT is a device that utilizes Near Infrared Spectroscopy to provide a non-invasive measurement of frontal lobe blood oxygenation over time.
15847705|NCT04061135|Procedure|Response Inhibition and Deep Brain Stimulation in Parkinson's disease|After creation of the burr hole and prior to DBS electrode placement, 1-2 subdural strip electrodes will be placed anteriorly or posteriorly from the cranial opening. These electrodes are routinely placed using this technique for seizure mapping, with arrays of electrodes (up to 6) being placed around the perimeter of the opening.14 Subdural strips vary in length and contact size (e.g., the 6-contact Ad-Tech strip), and are currently placed predominantly for studies of sensorimotor function,13 including at our institution (IRB-140327003). Placement over prefrontal areas is performed at other institutions.11-13 The DBS surgery will then proceed according to routine practice, and following lead placement in the optimal desired location, the research task paradigm will begin.
15847706|NCT04061122|Diagnostic Test|airway epithelial smear test|all patients will be subjected to all scheduled procedures: airways epithelial smear test, measurement of VOCs in exhaled air and airways slide sample culture
15847707|NCT04061109|Drug|Recombinant Human Coagulation FVIII|A kind of Recombinant Coagulation Factor VIII Injection produced by sponsor.
15847708|NCT04061096|Diagnostic Test|Evaluation of cold test|Cold test evaluation to describe the sensitivity level of teeth due to induce the hydrodynamic forces in dentine tubules.
15847709|NCT04061096|Diagnostic Test|Evaluation of electrical pulp test|Electrical pulp test evaluation to describe the sensitivity level of teeth due to induce the nerve fibers in pulp tissue.
15847710|NCT04061096|Diagnostic Test|Evaluation of pain during the treatment|Describe the sensitivity level due to induce the hydrodynamic forces during treatment procedure.
15847711|NCT04061083|Device|Smart Cuff Manager|Participant will be attached to the smart cuff manager within 4 hours after intubation. They will remain attached during the first 48 hours of intubation in the intensive care unit
15847712|NCT04061083|Device|Manometer|Participant will be attached to the manometer within 4 hours after intubation. They will assess 3 times per day during the first 48 hours of intubation in the intensive care unit
15847713|NCT04061070|Other|Supplementation with mix of threalose plus polyphenols|The patients will be treated with a mix of trehalose plus polyphenols for 60 days
15847714|NCT04061070|Other|No Supplementation with mix of threalose plus polyphenols|The patients will not be treated with a mix trehalose plus polyphenols for 60 days
15847715|NCT04061057|Drug|Lidocaine|"Drug: 1. Lidocaine Intravenous lidocaine bolus of 1.5mg/kg immediately after anesthesia induction followed by infusion at 2.0mg/kg/hr up to 1 hr after end of surgery.
~2. Fentanyl IV infusion via PCA (patient controlled analgesia) machine of fentanyl 10 μg/ml, ramosetron 0.3 mg, normal saline, total 100 ml, infusion rate 1 ml/hr, 1 ml bolus and lockout time 7 min."
15847716|NCT04061057|Drug|Normal saline|"Drug: 1. Normal saline Intravenous normal saline bolus of immediately after anesthesia induction followed by infusion up to 1 hr after end of surgery. Volume of normal saline is equal to lidocaine.
~2. Fentanyl IV infusion via PCA (patient controlled analgesia) machine of fentanyl 10 μg/ml, ramosetron 0.3 mg, normal saline, total 100 ml, infusion rate 1 ml/hr, 1 ml bolus and lockout time 7 min."
15847717|NCT04061044|Drug|Ophthalmic Insert|Travoprost, 0.32 mg
15847718|NCT04061031|Behavioral|Parent-Child Interaction Therapy (PCIT)|A trained clinician teaches the caregiver to deliver a number of behavior modification techniques for use with the child and coaches the caregiver in the delivery of those techniques.
15847719|NCT04061031|Behavioral|Child-Centered Therapy with Parent Education|A trained clinician delivers non-directive, child-centered treatment techniques with the child while providing education to the parent based on current recommendations from the Department of Health and Human Services' Child Welfare Information Gateway.
15847720|NCT04061005|Procedure|Cold snare polypectomy|CSP, which does not include electrocautery to do a polypectomy with a snare.
15847721|NCT04061005|Procedure|Hot snare polypectomy|HSP, which uses the electrocautery to do a polypectomy with a snare.
15847722|NCT04061005|Procedure|Endoscopic margin observation method|Endoscopic margin observation method, After rinsing the polyp specimen with physiological saline, fully natural extension, fixing it to the foam board with a needle, and observing the margin with a colonoscope or a magnifying colonoscope near-focus mode to determine whether there is residual polyp tissue.
15847723|NCT04060992|Drug|Elagolix 200 MG Oral Tablet [Orilissa]|oral tablet given twice daily
15847724|NCT04060979|Drug|Nitric Oxide|Nitric Oxide given intermittently via inhalation
15847725|NCT04060979|Other|Standard Supportive treatment|Standard Supportive treatment (including oxygen)
15847726|NCT04060966|Behavioral|Cold Pressor Task|The acute stress induction is called 'Cold Pressor Task' which consists of participants submerging their dominant forear, in ice-water (0-4°C) for 3 minutes (no-stress group uses warm water,~30°C).
15847727|NCT04060953|Other|Health-Related Quality of Life Report|Subject report and interpretation guide based on SPADE cluster scores
15847728|NCT04060940|Behavioral|Emotion Regulation Therapy: 8-session version|Emotion Regulation Therapy will be administered over 8 individual sessions on a weekly basis, resulting in a total required time commitment of 9 hours over the course of 8 weeks. The initial stage of treatment focuses on psychoeducation about anxiety and depression, individual patterns of these behaviors, emotions in recent situations, and self-monitoring of worry, anxiety, and depression. The sessions focus on the development of skills that help regulate one's emotional experience (i.e., recognizing emotions when they are happening, identifying the meaning of a given emotion experience, and soothing oneself in the context of negative emotional experiences). Following the development of these skills, sessions focus on the application of somatic awareness and emotion regulation skills while imagining emotionally evocative themes. The remaining sessions focus on terminating therapy, relapse prevention, and future goals.
15847729|NCT04060940|Behavioral|Emotion Regulation Therapy: 16-session version|Emotion Regulation Therapy will be administered over 16 individual sessions on a weekly basis, resulting in a total required time commitment of 18 hours over the course of 16 weeks. The initial stage of treatment focuses on psychoeducation about anxiety and depression, individual patterns of these behaviors, emotions in recent situations, and self-monitoring of worry, anxiety, and depression. The sessions focus on the development of skills that help regulate one's emotional experience (i.e., recognizing emotions when they are happening, identifying the meaning of a given emotion experience, and soothing oneself in the context of negative emotional experiences). Following the development of these skills, sessions focus on the application of somatic awareness and emotion regulation skills while imagining emotionally evocative themes. The remaining sessions focus on terminating therapy, relapse prevention, and future goals.
15847730|NCT04060927|Device|SGRT|Surface Guided Radiation Therapy
15847731|NCT04060914|Drug|Ticagrelor 90mg|Ticagrelor 90 mg plus aspirin for 12 months
15847732|NCT04060914|Drug|Ticagrelor 90mg/60mg|1 month after treatment with ticagrelor 90 mg plus aspirin, followed by treatment with ticagrelor 60 mg plus aspirin for 11 months
15847733|NCT04060914|Drug|Clopidogrel 75mg|Clopidogrel 75mg plus aspirin for 12 months
15847734|NCT04060901|Behavioral|CCSH Intervention for Teams|"CCSH Interventions for Teams will be a six session intervention. The groups meet once per week for 60 minutes for 4 weeks, coupled with 2 booster sessions over the following 2 months. Participants will receive the CCSH interventional approach, adapted for a group setting, which follows four stages: 1) Preparing the care responder; 2) Attuning to the Relationship; 3) Accessing Compassion, and 4) Entrusting the Careseeker.
~The CCSH approach will be used to assess group dynamics, individual member sources of distress, as well as existing resources for resilience and compassion. Through the intervention, resources will then be identified and accessed in order to respond to team (and individual) sources of distress with greater resilience and increased compassion toward self and others. CCSH clinicians will utilize group process skills to encourage team communication about work-related challenges, enhance team cohesion, and enable interpersonal support among members of the team."
15847735|NCT04060888|Drug|Ustekinumab (approximately 6 mg/kg)|Participants will receive ustekinumab approximately 6 milligram per kilogram via IV route based on body weight-range.
15847736|NCT04060888|Drug|Ustekinumab 90 milligram (mg)|Participants will receive 90 mg ustekinumab via SC route.
15847737|NCT04060888|Drug|Placebo|Participants will receive placebo matching to ustekinumab IV or SC.
15847738|NCT04060875|Device|Karuna Labs Virtual Reality Software|The subjects will engage in the three therapeutic modules: laterality, motor imagery, and 'mirroring.' The decision of which module to employ will be based on the subject's readiness and comfort on a case-by-case basis. A subject visit can be expected to last 40 minutes, with enough time to complete PHQ-9, and to accustom to the virtual reality setup by playing in a non-therapeutic virtual environment should they choose to do so. Time in the virtual reality is expected to last approximately 20 minutes per session.
15847839|NCT04059991|Biological|Influenza Vaccination|Only subjects vaccinated against influenza will be enrolled. The study itself is observational
15847739|NCT04060862|Drug|Ipatasertib|Phase 1b: Ipatasertib, 300 mg starting dose administered orally once daily (PO QD) during an initial 5-7 day run-in period, then continued on Days 1-21 during the first cycle. Starting with Cycle 2, Day 1 ipatasertib will be taken orally once daily on Days 1-21 of each 28-day cycle. Phase 3: Ipatasertib, administered PO QD on Days 1-21 of each 28-day cycle at the dose confirmed in the Phase Ib portion.
15847740|NCT04060862|Drug|Placebo|Phase 3: Matching placebo, administered PO QD on Days 1-21 of each 28-day cycle at the dose confirmed in the Phase Ib portion.
15847741|NCT04060862|Drug|Palbociclib|Palbociclib, administered PO QD on Days 1-21 of each 28-day cycle.
15847742|NCT04060862|Drug|Fulvestrant|Fulvestrant, 500 mg administered as two intramuscular injections of 250 mg each on Cycle 1 Days 1 and 15 and Day 1 of each subsequent 28-day cycle.
15847743|NCT04060849|Drug|Nozin|Given via nasal single-use popswabs or single-use cotton tipped applicators
15847744|NCT04060849|Other|Best Practice|Receive standard of care
15847745|NCT04060836|Drug|Xyntha|Recombinant Coagulation Factor VIII Injection produced by Pfizer Inc.
15847746|NCT04060836|Drug|Recombinant Coagulation Factor VIII Injection|A kind of Recombinant Coagulation Factor VIII Injection produced by sponsor.
15847747|NCT04060823|Other|Easy Breathing program|Easy Breathing is a longstanding, nationally recognized program that translates asthma management guidelines into a standardized and usable format for healthcare providers. As part of the program primary healthcare providers and school health personnel (e.g., nurses, health aides) identify children at-risk for adverse asthma outcomes and provide care coordination services. Patients receive a tailored, comprehensive Asthma Treatment Plan with information regarding daily medication use and management of acute symptoms based on asthma severity.
15847748|NCT04060810|Other|MR CSF flowmetry|MR flowmetry in grey zone hydro cephalic patients followed by ventriculoperitoneal shunt
15847749|NCT04060797|Device|endovascular denervation|multi-electrode catheter-based endovascular denervation
15847750|NCT04060784|Device|Immediate implant placement and provisionalization|Failing tooth will be extracted and immediate placed endosseous implant
15847751|NCT04060771|Drug|Palonosetron|prophylaxis of postoperative nausea and vomiting
15847752|NCT04060771|Drug|Dexamethasone|prophylaxis of postoperative nausea and vomiting
15847753|NCT04060758|Drug|PA5108 Latanoprost FA SR Ocular Implant|Ocular Implant
15847754|NCT04060745|Other|cooling using a water-perfused vest|"BAT is activated by cold exposure. Each participant will have a shivering threshold test performed before entering the cooling arm. Participants will be gradually cooled (decreasing the temperature in the cooling vest by 0.6C every 15 min. until 3.8C) using a perfused cooling vest until they start to shiver. The temperature in which they start to shiver will be noted. If shivering has not occurred at 3.8C after 15 min. they will stay at the temperature for 45 min. in total or until shivering occurs. Shivering is defined by subjective perception of shivering by the participant in a numeric scale (NRS) where 0 refers to I'm not shivering and 10 refers to I'm shivering a lot and visual inspection by the investigator. The temperature used in the cooling arm will be set a few degrees above the shivering threshold test or at 3.8C if shivering did not occur.
~During cooling indirect calorimetry and OGTT will be performed and finally the DMI scan will be performed"
15847755|NCT04060745|Other|thermoneutrality|In the thermoneutrality arm participants will rest in thermoneutrality (22C) for one hour. Before the DMI scan indirect calorimetry will be performed
15847756|NCT04060732|Device|Flash Glucose Monitoring-FGM|"The Flash Glucose Monitoring-FGM is a real-time glycemic monitoring system called hybrid will be assigned to the enrolled patients at baseline until the end of follow-up after 12 months."
15847757|NCT04060719|Drug|BI 894416|tablet
15847758|NCT04060719|Drug|Rifampicin|tablet
15847759|NCT04060706|Radiation|Radical Image-Guided Radiotherapy|Questionnaires administered will monitor the clinical toxicity experienced by each patient up to 5 years post radiotherapy
15847760|NCT04060693|Device|P0.5|Investigational Medical Device collecting spectral raman data from tissue.
15847762|NCT04060667|Combination Product|Wireless physiologic monitoring|The intervention in this study is the use of a wireless monitor to perform physiologic monitoring of women undergoing emergency cesarean delivery for the first 24 hours after completion of the cesarean and send alerts to responding clinicians should vital signs fall out of a pre-specified range.
15847763|NCT04060654|Drug|Sublocade|SUBLOCADE to be administered approximately every 4 weeks per local standard of care
15847764|NCT04060641|Genetic|Geneticure for RDN Genetic Panel|This retrospective trial will include the collection of DNA using buccal swabs and the assessment of 22 genotypes for scoring to assess response to renal denervation
15847765|NCT04060628|Drug|NanoDoce (sterile nanoparticulate docetaxel) Powder for Suspension|
15847766|NCT04060615|Procedure|percutaneous coronary intervention|PCI of the chronic total occlusion of the coronary artery
15847767|NCT04060602|Behavioral|Personalized Feedback|A report comparing the participant's cannabis use to peer usage, and summarizing problems experienced and risk associated with future use.
15847768|NCT04060602|Behavioral|Education|Canada's Lower-Risk Cannabis Use Guidelines prepared by the Centre for Addiction and Mental Health which outlines methods to help reduce health risks associated with cannabis use.
15847769|NCT04060589|Other|Tissue donation|Biopsies will be performed as part of standard of care, additional cores will be performed for research. Access to standard of care prostate biopsy tissue will also be requested after standard of care reporting is complete.
15847770|NCT04060589|Other|Blood Donation|Phlebotomy will be performed prior to tissue collection following trust standard operating procedures or drawn when cannula already in situ in preparation for the prostate biopsy.
15847771|NCT04060589|Other|Urine Donation|Urine will be collected prior to prostate biopsy
15847772|NCT04060589|Other|Healthcare data linkage|Men will consent to healthcare data linkage via national databases.
15847773|NCT04060576|Procedure|Dry needling treatment with a thinner needle|We will make an application with the dry needling technique with a fine needle on the myofascial trigger points of the gastrocnemius muscle.
15847774|NCT04060576|Procedure|Dry needling treatment with a medium-sized needle|We will make an application with the dry needling technique with a medium-sized needle on the myofascial trigger points of the gastrocnemius muscle.
15847775|NCT04060576|Procedure|Dry needling treatment with a thickest needle|We will make an application with the dry needling technique with the thickest needle on the myofascial trigger points of the gastrocnemius muscle.
15847776|NCT04060563|Device|INSPIRSTAR IS02 MICROCURRENT STIMULATOR|"Investigators will use the Inspirstar microcurrent stimulator TENS device. It is an FDA 510k approved portable hand-held device used for the symptomatic relief of chronic pain. It generates low current intensity pulses in the ranges of 20μA to 400μA.
~For this study, investigators will use a treatment range of 100-300μA. Frequency specific microcurrent therapy (100-300μA microccurrent amps) with Diastasis Recti Repair protocol (8), times 2 treatments for a consistent total of 11 hours 32 minutes."
15847777|NCT04060550|Biological|Xolair|This is in vitro mechanistic study. No drug will be given in vivo to patients.
15847778|NCT04060537|Other|Laboratory analysis of samples|RNA sequencing, immunohistochemistry, immunofluorescence, and cytometry of tumour tissues
15847779|NCT04060537|Other|Application of machine learning|Using machine learning to interrogate data generated from analysis of Renal Cell Cancer tumours using RNA sequencing, immunohistochemistry, immunofluorescence, cytometry, and MRI imaging of tumours.
15847780|NCT04060511|Drug|HS-10342|HS-10342 either 25mg, 50mg, 100mg, 150mg, 200mg given orally, QD or 50mg, 100mg, 150mg, 200mg, 250mg, 275mg given orally, BID
15847781|NCT04060498|Behavioral|Mindfulness intervention|MBI-p focuses on simplicity, for both facilitators and patients; and use acceptance and embracing attitude for fear and sadness. The ultimate aims are to help patients achieve a greater sense of peace and calmness, and facilitate participants in handling everyday stress and conflicts.
15847782|NCT04060498|Behavioral|Psychoeducation intervention|Psychoeducation focuses on disseminating information about common mental disorders, psychosis (its causes, risk factors and trajectory), and methods of treatment for psychosis.
15847783|NCT04060472|Drug|albumin-bound paclitaxel + oxaliplatin|Using albumin-bound paclitaxel (125 mg/m2, d1, 8, 15, ivgtt) + oxaliplatin (80 mg/m2, d1, 8, ivgtt) with or without other chemotherapeutic drugs, 28 days /cycle, until the disease progresses or patients can not tolerate toxicity. The investigators decide the follow-up treatment plan.
15847784|NCT04060459|Drug|Paclitaxel-binding albumin|Paclitaxel-binding albumin 260 mg/m2，d1，ivgtt；cisplatin 75 mg/m2，d1，ivgtt
15847785|NCT04060446|Device|Medical Device|Smoke cigarettes with CReSSMicro topography measurement device and BioRadio device
15847786|NCT04060446|Other|Questionnaire Administration|Ancillary studies
15847787|NCT04060446|Behavioral|Tobacco Smoking|Smoke cigarettes
15847788|NCT04060433|Behavioral|Family Therapy|Swedish version of the evidence based manualized Family Therapy
15847789|NCT04060420|Other|Comprehensive sexual and reproductive health services|The intervention includes community-based and peer-led delivery of comprehensive sexual and reproductive health services and a Yathu Yathu prevention points card, which is a card that adolescents and young people can use to gain points for accessing services and use these points to redeem rewards.
15847790|NCT04060407|Drug|CD24Fc|CD24Fc will be administrated as IV infusion in a dose of 480 mg, q3w x 4, then q4w for up to 6 times.
15847791|NCT04060407|Drug|Ipilimumab|Ipilimumab will be administrated as IV infusion, q3w x 4. For metastatic melanoma, the dose will be 3mg/kg, q3w x4.
15847792|NCT04060407|Drug|Nivolumab|Nivolumab will be administrated as IV infusion. For metastatic melanoma, the dose will be 1mg/kg, q3w x 4, then 480 mg, q4w for up to 1 year.
15847793|NCT04060394|Drug|Phase I and Phase II: LAE001/prednisone + afuresertib|In the Phase I portion of the study will identify the RPD2 of the combined therapy. In the Phase II will evaluate LAE001/prednisone + afuresertib at the RP2D (Arm 1) and docetaxel/prednisone + afuresertib (Arm 2).
15847794|NCT04060381|Drug|Blood transfusion, Ibuprofen, or epinephrine, norepinephrine or dopamine|Treatment/ intervention given according to standard protocols at the Neonatal Intensive Care Unit
15847795|NCT04060368|Procedure|Endoscopic Sleeve Gastroplasty (ESG) with OverStitch® system + Lifestyle modifications|Endoscopic technique defined as a gastric restriction by means of continuous sutures of the entire gastric wall of the antrum and body, transmurally, in order to simulate a gastric sleeve, in the same way as sleeve gastrectomy surgery. Gastroplasty is performed using an endoscopic suture system (OverStitch, Apollo Endosurgery Inc., Austin, Texas, USA) inserted into a dual-channel endoscope (GIF-2T160, Olympus Medical Systems Corp., Tokyo, Japan).
15847796|NCT04060368|Procedure|Laparoscopic Sleeve Gastrectomy (LSG) + Lifestyle modifications|Minimally invasive surgical technique defined as a gastric restriction by means of an excision approximately 80% of the stomach along the greater curvature.
15847799|NCT04060342|Drug|GB1275|Oral
15847800|NCT04060342|Drug|nab-paclitaxel and gemcitabine|IV infusion
15847801|NCT04060342|Drug|pembrolizumab|IV infusion
15847802|NCT04060329|Behavioral|coopeRATE Prompt|The coopeRATE Prompt intervention is a set of two questions delivered to patients immediately before the clinical encounter that elicit their concerns and goals.
15847803|NCT04060316|Drug|GLS-1200|GLS-1200 is given as a nasal spray using an atomizer
15847804|NCT04060316|Drug|Placebo|Placebo is given as a nasal spray using an atomizer
15847840|NCT04059978|Drug|CBD|1600mg cannabidiol, single oral dose (8 ml oily solution)
15847841|NCT04059978|Drug|Placebo|Placebo p.o, single oral dose (8 ml oily solution)
15847842|NCT04059978|Drug|Remifentanil|Remifentanil 0.1 µg/kg/min i.v. for 30 min
15847843|NCT04059965|Other|Panel Management for Anticoagulation Therapy|Patients in the intervention arm will receive notifications reminding them of upcoming labs and appointments. We hypothesize this will improve adherence and therapeutic control and reduce risk for bleeds and/or strokes
15847805|NCT04060303|Procedure|Perioperative surgical care|The ENRICH-US Protocol includes perioperative counseling and education, maintaining euvolumia through limited perioperative fasting and limited intraoperative fluid resuscitation, early enteral intake and mobilization, limited use of opioids, and non-routine use of surgical drains and tubes. Elements span the pre-, intra-, and post-operative experience for patients and involve care coordination among surgery, anesthesia, and nursing providers. Though individually simple, the concomitant implementation of the combined elements results in a markedly improved patient care experience that mitigates the physiologic stress of surgery and hastens recovery.
15847806|NCT04060290|Other|Observational study|Observational study of this study, no interventions involved
15847807|NCT04060277|Drug|Letermovir|Given as SOC
15847808|NCT04060277|Biological|Multi-peptide CMV-Modified Vaccinia Ankara Vaccine|Given IM
15847809|NCT04060277|Other|Placebo Administration|Given IM
15847810|NCT04060264|Biological|BCD-148|"Active substance of BCD-148 is eculizumab - a monoclonal antibody that targets complement protein C5.
~Cycle 1 (induction therapy): 600 mg of eculizumab QW for the first four weeks; Cycle 2 (maintenance therapy): 900 mg of eculizumab at Week 5 and 900 mg of eculizumab every 14±2 days until Week 27 (inclusive) afterwards (dosing regimen for the main study period).
~QW - once weekly"
15847811|NCT04060264|Biological|Soliris|"Active substance of Soliris is eculizumab - a monoclonal antibody that targets complement protein C5.
~Cycle 1 (induction therapy): 600 mg of eculizumab QW for the first four weeks; Cycle 2 (maintenance therapy): 900 mg of eculizumab at Week 5 and 900 mg of eculizumab every 14±2 days until Week 27 (inclusive) afterwards (dosing regimen for the main study period)."
15847812|NCT04060251|Device|CyMedica e-vive™ System; CY-1000|"All the patients in Group 2 will be given the CyMedica Orthopedics e-vive system 3 weeks before the surgery. The patients will begin using the unit after their first pre-intervention measurements are taken.
~Patients will be instructed to apply the e-vive NMES Strength therapy twice a day, 5 days a week. The NMES Strength program is 20 minutes in length. Treatment intensity (adjustable from 1 to 100 in NMES programs) is required to be set at the highest tolerable limit for the patients.
~Stimulation from the garment will have the following parameters: frequency of 50 Hz; pulse duration of 5 ms; time on: 12.8 seconds; and time off: 10 seconds. The total contraction time in a 20-minute treatment will be 11 minutes. The waveform will be pulsed and asymmetrical."
15847813|NCT04060251|Other|iGetBetter telemedicine physical therapy|Group 1 patients will only use a Post-Op program from iGetBetter for the first 3 weeks after surgery. After those 3 weeks have elapsed, Group 1 patients will receive outpatient physical therapy in addition to iGetBetter, approximately twice per week for the next 6-8 weeks as all other groups.
15847814|NCT04060238|Diagnostic Test|Anomaloscope (colour vision test)|"The Heidelberg Multi Colour (HMC) Anolmaloscope (Oculus Inc., Dutenhofen/FRG) is used to differentiate between normal controls (normal trichromatopsia) and test subjects with protanopia (inherited red colour blindness)"
15847815|NCT04060225|Other|Coffee|Starbuck's brand blonde roast coffee, 20 ounces
15847816|NCT04060212|Other|Tuna fish|Six meals of tunafish (~200gms) will be consumed. Three meals will be consumed in a period of 14 days, and a subsequent 3 meals will be consumed within a 14 day period six month after the first 3 meals.
15847817|NCT04060212|Dietary Supplement|prebiotic|Prebiotin brand prebiotic will be consumed at 8grms/day for a period of 75 days. The prebiotic administration will begin with the second grouping of 3 fish meals.
15847818|NCT04060199|Drug|Viltolarsen|IV infusion
15847819|NCT04060199|Drug|Placebo|IV infusion
15847820|NCT04060186|Procedure|Balloninflation|Patient will inflate into a ballon made by a handglove 2-3times/h from 8:00-20:00 after evacuation of chronic subdural hematoma.
15847821|NCT04060173|Drug|ABP-671|ABP-671 is an investigational drug
15847822|NCT04060173|Other|Placebo|Matching placebo
15847823|NCT04060160|Other|Self- learning software that can detect acne lesions|Self- learning software that can detect acne lesions from patients who take a picture of their face every single day for 3 months with a secure mobile phone.
15847824|NCT04060160|Other|Patient reported outcomes|Collection of patient reported outcomes and clinical data via a mobile electronic case report form
15847825|NCT04060147|Drug|CILO|Tablets administered orally once daily
15847826|NCT04060134|Other|HADM|Human acellular dermal matrices are used for the repair or replacement of damaged or inadequate integumental tissue or for other homologous uses of human integument.
15847827|NCT04060108|Drug|MDMA|.75mg/kg, 1.5 mg/kg, Placebo
15847828|NCT04060095|Procedure|standardized noxious stimulus under general anesthesia.|"50 adult patients undergoing general anesthesia for any types of surgery and who have been chronically treated with β1-adrenergic antagonists for at least three months. .Induction of anesthesia will be standardized.
~At least 10 min after the post-intubation decrease of the remifentanil infusion rate, the OR team will stop any physical contact/stimulation of the patient allowing at least 3-minutes.
~At this point, the standardized electrical (tetanic) stimulation will be applied on the area of the ulnar nerve at the wrist level, at a frequency of 100 Hz and a current of 70 mA for a duration of 30 seconds, followed by 3 minutes of observation period without any other stimulation of the patient by the anesthesia or the surgical team. At the end of the observation period, the study is discontinued and the anesthesia will be conducted at the discretion of the anesthesiologist in charge of the patient."
15847829|NCT04060082|Other|Telephone Interview|Participants will be asked to answer questions about their experiences with FTD.
15847830|NCT04060069|Other|Ringer Lactate|Fluids
15847831|NCT04060043|Drug|Goserelin Acetate|The Pepti 10.8mg (goserelin acetate) implant is supplied as a cylindrical rod of biodegradable and biocompatible D, L Lactic and glycolic acids copolymer. Each implant contains goserelin acetate equivalent to 10.8mg of goserelin as well as a blend of high and low molecular weight range of D, L lactic and glycolic acids copolymer to total a weight of approximately 36.0mg per depot. The implant will be injected subcutaneously through the patient's anterior abdominal wall.
15847832|NCT04060030|Drug|Levoleucovorin Calcium|Liquid leucovorin calcium dosed by weight
15847833|NCT04060030|Other|Placebo|Placebo
15847834|NCT04060017|Drug|Levoleucovorin Calcium|Liquid leucovorin calcium dosed by weight
15847835|NCT04060017|Other|Placebo|Placebo
15847836|NCT04060004|Other|Dry needling|Dry needling is a technique used by physiotherapists.
15847837|NCT04060004|Other|Sham dry needling|Sham dry needling is a technique used by physiotherapists to compare the effects of dry needling.
15847845|NCT04059952|Procedure|Electroconvulsive Therapy|Electrical currents are passed through the brain to intentionally trigger a controlled seizure in order to produce a therapeutic change in neuro-chemistry and circuitry.
15847846|NCT04059939|Other|Reading|Small group reading instruction
15847847|NCT04059939|Behavioral|Anxiety Management|small group anxiety management skills instruction
15847848|NCT04059939|Other|Classroom Business as Usual|Classroom Business as Usual
15847849|NCT04059939|Other|Attention Control (math practice)|Attention Control (math practice)
15847850|NCT04059926|Other|insert apossing lumen metal stent|insert apossing lumen metal stent
15847851|NCT04059913|Drug|FG-4592|Roxadustat will be dosed orally
15847852|NCT04059900|Drug|STW5 (Iberogast®, BAY98-7411)|The medication was applied daily per os (orally, p.o.) from day 0 to day 28. The dosage was 20 drops three times daily before the meals.
15847853|NCT04059900|Drug|Placebo|The medication was applied daily p.o. from day 0 to day 28. The dosage was 20 drops three times daily before the meals
15847854|NCT04059887|Drug|Atezolizumab Injection [Tecentriq]|Blood sampling will be performed before and after 3rd cycle of atezolizumab for evaluation of tumor mutation burden
15847855|NCT04059874|Drug|donafenib tablets|donafenib tablets 100mg qd dose group and donafenib tablets 100mg bid dose group
15847856|NCT04059861|Diagnostic Test|Ultrasound|enrolled patients will be investigated by ultrasound two times, awake in the clinic and in narcosis before the surgery. For those with tongue cancer ultrasound will be used during the surgery to visualise the deep margin of the tumour.
15847857|NCT04059848|Combination Product|tDCS(Intelect Mobile Stimulation and Combination, DJO, France)|
15847858|NCT04059848|Combination Product|NMES(Enraf Nonius, Endomed-182, Netherlands)|
15847859|NCT04059835|Other|OptiBra study|compare two different bra after breast cancer surgery
15847860|NCT04059822|Other|Slow and deep breathing|Please see arm description
15847861|NCT04059809|Device|Photobiomodulation|Photobiomodulation will be with the Cicatrillux (Cosmedical®) LED that contains 36 red light emitters in a 10x12 cm neoprene plate with 650 nm LED wave length whose optical spot diameter is 5 mm and with an average wave length of 2 ~ 5 mw for 10 minutes that will be placed over the area that will be irradiated for 10 minutes;
15847862|NCT04059796|Device|Omega Gemini III Rev 2 Device|Eyes randomized to receive the Gemini III Rev 2 device will receive the study device in conjunction with an approved monofocal or toric IOL post cataract extraction
15847863|NCT04059796|Device|Control Eye|Control eyes will receive an approved monofocal or toric IOL post cataract extraction
15847864|NCT04059783|Drug|STW5 (Iberogast®, BAY98-7411)|The medication was applied 3 x 20 drops per day orally, before or at meals with some liquid, ideally three weeks
15847865|NCT04059770|Drug|single dose of L-AmB|(i) single IV dose of 10 mg/kg of L-AmB on day 1;
15847866|NCT04059770|Drug|2 doses of L-AmB|(ii) IV dose of 10 mg/kg of L-AmB on day 1, followed by 5 mg/kg of L-AmB on day 3;
15847867|NCT04059770|Drug|2 weeks of L-AmB|(iii) IV dose of 3 mg/kg of L-AmB for 2 weeks.
15847868|NCT04059757|Biological|Fecal Microbiota Transplantation (FMT)|1 dose = 30 capsules on day 1 of Fecal Microbiota Transplantation
15847869|NCT04059744|Device|Fun-Knee|"Portable and low cost sensors are used in the Smart Knee Sleeve. The sensor system is composed of two inclinometers and one Bluetooth transmitter.
~Fun Knee™ contains total knee replacement exercises that are gamified and supported on mobile device running on Android or iOS platforms. The mobile apps is able to capture the angle a and position data from the two inclinometers on smart knee sleeve.The free-sized knee sleeve prototypes are purchased and assembled by our collaborating vendor."
15847870|NCT04059731|Dietary Supplement|Nutrition supplement|Administration twice a day of Survimed OPD or Impact/Atempero depending on arm assigned during 5 postoperative days
15847871|NCT04059718|Behavioral|SCI Thrive Peer-Led Online Self-Management Program|6 week online course in self-management for individuals with spinal cord injuries. This was developed by a team using principles of cognitive behavioral techniques.
15847872|NCT04059705|Behavioral|Dual-Task Training|The ThinkFIT intervention will involve two days per week participation in simultaneous cognitive and motor training activities, facilitated by the SMARTFit Multisensory FItness System.
15847873|NCT04059692|Other|Cervical manipulation intervention|Cervical manipulative technique
15847874|NCT04059692|Other|Placebo intervention|Sham intervention
15847875|NCT04059679|Drug|Rivaroxaban 2.5 Mg Oral Tablet|EC aspirin (81mg qd) plus rivaroxaban (2.5 mg bid)
15847876|NCT04059679|Drug|Aspirin 81 mg|EC aspirin 81 mg qd
15847877|NCT04059666|Other|Investigational|Cow's milk-based Infant Formula with whey protein-lipid concentrate
15847878|NCT04059666|Other|Control|Cow's milk-based Infant Formula
15847879|NCT04059653|Device|Electrical stimulation|Electrical stimulation device
15847880|NCT04059653|Other|Treatment as usual|GP treatment as usual
15847882|NCT04059627|Device|Heart Track|"Description of the device: Wearable heart rate sensors are used in Heart-track, and a receiver on a smartphone app. Real-time wireless heart rate data is sent to paired mobile device with a wireless distance of up to 10m. The sensor is able to monitor a heart rate range of 30 to 240 beats per minute.
~Another component of Heart-track is a Heart-track mobile app which captures and reflect real-time heart rate from the heart rate sensor. The mobile app also includes warm-up and cool down exercises that are gamified and supported on a smart-phone running on Android or iOS platforms.
~The HR sensor will be purchased by our collaborator, Immersive Play Pte Ltd."
15847883|NCT04059614|Procedure|HFNC; COT|"HFNC: high-flow nasal cannula therapy COT: conventional oxygen therapy"
15847884|NCT04059601|Diagnostic Test|Magnetic resonance cholangiography|preoperative MRCP in acute cholecystitis before cholecystectomy
15847885|NCT04059601|Diagnostic Test|Intraoperative cholangiography|Intraoperative cholangiography in acute cholecystitis during cholecystectomy
15847886|NCT04059588|Drug|2141 V-11|intratumoral injection of 2141-V11
15847973|NCT04058899|Drug|Dexmedetomidine|sedative and might be analgesic drug
15847974|NCT04058899|Drug|Nalbuphine|agonist antagonist narcotic
15847887|NCT04059575|Other|Kinesio Taping (Performance Plus)|PP and GT taping applications were done by using kinesio taping muscle facilitation techniques to Quadriceps and Gastrosoleus muscles. I tape with a tension of 10-35% was used for muscle facilitation. All patients were assessed by an experienced physiotherapist, and the tapings were done by another experienced physiotherapist in order to provide a single blind structure of the study.
15847888|NCT04059575|Other|Kinesio taping (Gold Tex)|PP and GT taping applications were done by using kinesio taping muscle facilitation techniques to Quadriceps and Gastrosoleus muscles. I tape with a tension of 10-35% was used for muscle facilitation. All patients were assessed by an experienced physiotherapist, and the tapings were done by another experienced physiotherapist in order to provide a single blind structure of the study.
15847889|NCT04059562|Combination Product|Combination of Lonsurf® and Campto®|"Trifluridine/Tipiracil (Lonsurf®) and Irinotecan (Campto®)
~Trifluridine/Tipiracil will be administered at a dose of 25 mg/m2 / dose twice daily on days 1-5 followed by a 9-days recovery period from day 6 trough day 14 of each 14-days treatment cycle.
~Irinotecan will be administered at the same time as Trifluridine/Tipiracil (Lonsurf®) on day 1 of each cycle at a dose of 180 mg/m2 / dose."
15847890|NCT04059549|Behavioral|PartnerCHESS|"Patients randomized to the PartnerCHESS group will receive all A-CHESS services plus the following services from ABCT:
~Urge discussion. Daily EMAs will track preconditions for relapse (urges), review urge reduction options on PartnerCHESS, and encourage discussions between partners on the causes of and ways to reduce urges.
~Homework checklist. Tracks which interventions the couple is using/practicing, along with resources to help.
~Relapse plan. Monitoring and reminders of steps planned for relapse prevention. Reminders. Reminders to notice something positive in partner, of reasons to stay sober, to take meds, etc.
~Trigger identification and removal. During set-up, patient and partner enter triggers. PartnerCHESS will quiz couples on upcoming trigger events and remind them of ways to address each."
15847891|NCT04059549|Behavioral|A-CHESS|A-CHESS control group
15847892|NCT04059536|Device|Roxwood Anchoring Catheters|Anchoring catheters
15847893|NCT04059536|Drug|Acetylsalicylic Acid|Oral Tablet
15847894|NCT04059536|Drug|Heparin|Intravenous Injection
15847895|NCT04059523|Drug|S6G5T-3|once daily
15847896|NCT04059523|Drug|Retin-A® 0.1% Cream|once daily
15847897|NCT04059510|Procedure|rectovaginal swab|Self taken rectal and vaginal swab
15847898|NCT04059510|Procedure|pregnancy test|Urine pregnancy test
15847899|NCT04059510|Procedure|Menstrual cup|Menstrual cup vaginal fluid collection
15847900|NCT04059510|Procedure|Blood test|Venous blood sample
15847901|NCT04059510|Other|Focus group|Focus group responses will be audio-recorded, transcribed, and analysed by developing a coding framework and identifying emerging themes
15847902|NCT04059497|Behavioral|Exercise condition|Each participant in the intervention group can freely choose a handgrip of strength from 10 to 25kg which can be gripped with adequate grip strength. The PI will play the short video (5 minutes, www.youtube.com/watch?v=mZex2Wwy3fU) about the 10s-E for the participant, including (1) rapid grip-and-release the handgrip for at least 30 times in 10seconds in each hand, and (2) short-bout hand pushing and pulling exercises without handgrip. During the video, participants are asked to follow the 10s-E demonstrated by the medical professor. After the video, the PI will guide the participant to repeat the 10s-E for 5 times within the next 5 minutes. If participants feel pain in their hands, they can slow down the exercise. Between each exercise set, rest time for 10-20 seconds will be allowed. After practicing all these exercises, participants are asked to complete a post-intervention questionnaire
15847903|NCT04059497|Behavioral|Healthy diet condition|The control group will watch two videos on healthy diet (https://www.youtube.com/watch?v=w_u4BYV2Okc). Similar to the 10s-E condition, they will complete a post-intervention questionnaire after the two videos.
15847904|NCT04059484|Drug|Amcenestrant|"Pharmaceutical form: Capsule
~Route of administration: Oral"
15847905|NCT04059484|Drug|Fulvestrant|"Pharmaceutical form: Solution for injection
~Route of administration: Intramuscular"
15847906|NCT04059484|Drug|Anastrozole|"Pharmaceutical form:Tablets or capsules
~Route of administration: Oral"
15847907|NCT04059484|Drug|Letrozole|"Pharmaceutical form: Tablets or capsules
~Route of administration: Oral"
15847908|NCT04059484|Drug|Exemestane|"Pharmaceutical form: Tablets or capsules
~Route of administration: Oral"
15847909|NCT04059484|Drug|Tamoxifen|"Pharmaceutical form: Tablets or capsules
~Route of administration: Oral"
15847910|NCT04059471|Biological|Yellow fever vaccine, Institut Pasteur|Full dose and 500IU/dose
15847911|NCT04059458|Device|Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane)|Device: Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane) Following open flap debridement of mandibular grade II furcation defects, regenerative therapy is performed with biphasic calcium phosphate + collagen membrane.
15847912|NCT04059458|Drug|Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain)|Drug: Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain) Following open flap debridement of mandibular grade II furcation defects, regenerative therapy is performed with biphasic calcium phosphate + enamel matrix proteins.
15847913|NCT04059445|Device|Biphasic calcium phosphate (Straumann Bone Ceramic) + collagen membrane (Straumann Jason Membrane)|Regenerative therapy with biphasic calcium phosphate + collagen membrane.
15847914|NCT04059445|Drug|Biphasic calcium phosphate (Straumann Bone Ceramic) + enamel matrix proteins (Straumann Emdogain)|Regenerative therapy with biphasic calcium phosphate + enamel matrix proteins.
15847915|NCT04059432|Diagnostic Test|Tooth Wear and Musculoskeletal Disorders evaluation|"Evaluation of dental wear by BEWE (Basic Erosive Wear Examination: score 0-3) examination and Musculoskeletal disorders are listed by the NORDIC questionnaire developed by Kuorinka et al. (2001)"
15847916|NCT04059419|Behavioral|PARQVE Program|Two days of lectures about knee OA, come to the hospital at months 1, 3 and 5 after the first class to consult about nutritional habits to be improved, participate in a group therapy session with the psychologists and sessions with the physical educators.
15847917|NCT04059419|Behavioral|Geriatric Care|Remain under geriatric care as usual
15847918|NCT04059406|Drug|IONIS TMPRSS6-LRx|IONIS TMPRSS6-LRx administered subcutaneously
15847925|NCT04059354|Behavioral|Speech therapy addressing phonology and motor learning|Determine the efficacy of a newly devised intensive speech treatment plan (DS-DxTx) focusing on vowels that combines efficacious treatment approaches to use with individuals with Down syndrome. The phonological speech intervention, Phonological Cycles approach, is designed for use with children with highly unintelligible speech and the speech motor learning intervention, Script training is a functional treatment to promote phrase level productions. Both approaches are documented to be efficacious with other speech disorders. The proposed approach takes into account the multiple deficits commonly present in individuals with DS, and based on the acoustic and perceptual finding on vowels from our VTLab. Acoustic and perceptual measures will be used to assess treatment efficacy.
15847926|NCT04059341|Device|Low Intensity Extracorporeal Shockwave Therapy (LI-ESWT)|Five sessions of penile Low Intensity Extracorporeal Shockwave Therapy initiated three weeks after radical prostatectomy.
15847927|NCT04059328|Procedure|Surgical training|This was a gyn laparoscopy training and simulation course
15847928|NCT04059315|Other|surgical treatment of facial bone fracture|oral and maxillofacial injury patients admitted in our hospital. patients are getting treatment of soft and bone frature as follow soft tissue repaire, IMF, ORIF, consrvative.
15847929|NCT04059302|Behavioral|Internet-delivered Cognitive Behavioral Therapy for Insomnia|The therapy consists of 6 modules or 'cores' that are introduced on a weekly basis. The cores are designed to decrease sleep-inhibiting cognitions and behaviors, and to alter sleep-wake schedules.
15847930|NCT04059289|Other|Posterior chamber intraocular lens (IOL)|This is NOT an interventional study; the intervention (surgical procedure) has been performed PRIOR to the inclusion in this study
15847931|NCT04059276|Diagnostic Test|MRI|We will examine chronic (>3 months post stroke) patients using functional, structural, and metabolic MRI in both the brain and the spinal cord.
15847932|NCT04059276|Diagnostic Test|MRI|We will examine healthy control participants using functional, structural, and metabolic MRI in both the brain and the spinal cord.
15847933|NCT04059250|Device|Nobio composite|Nobio has developed a bactericidal composite, which does not leak out the bactericidal nano fillers
15847934|NCT04059250|Device|traditional composite|traditional composite which has no bactericidal activities
15847935|NCT04059237|Behavioral|Web based decision aid intervention|Decision aid tool (website) to assist young adult female cancer survivors in making decisions and preparing for family-building after cancer.
15847936|NCT04059224|Drug|Trametinib|Trametinib 2 mg once a day by mouth.
15847937|NCT04059224|Drug|Dabrafenib|Dabrafenib 50 mg twice a day by mouth. Dabrafenib can be uptitrated to 150 mg twice a day in case of dose-limiting trametinib-associated skin toxicity.
15847938|NCT04059211|Diagnostic Test|Urinary dipstick|Sensitivity and specificity of urinary dipstick for proteinuria in emergency departments
15847939|NCT04059198|Drug|Inarigivir soproxil|Inarigivir soproxil 400 mg tablets
15847940|NCT04059198|Drug|Tenofovir alafenamide fumarate (TAF)|Tenofovir alafenamide fumarate 25 mg tablet
15847941|NCT04059185|Other|Triple P-Level 2|Triple P-Level 2 (TPL2) consists of a brief, 30 minute, one-on-one consultation with a parenting professional followed by a phone call from that professional roughly 2 weeks later. TPL2 will be delivered on an individual level and consist of a brief, 20 to 40 minute, one-on-one parenting consultation. Parents will receive a positive parenting booklet. They also will be offered parenting tip sheets that are designed to provide basic information on the prevention and management of common behavioral, emotional and developmental problems. All materials are: 1) written in simple English; 2) understandable at a sixth grade reading level; 3) gender-sensitive; and 4) avoid technical and colloquial expression that may pose barriers from non-English speaking backgrounds. Participants will receive a follow-up phone call to check on the family's progress and offer any additional needed advice.
15847942|NCT04059185|Other|Play Nicely|"Play Nicely is a brief, multimedia, computer-based educational program. The online program uses narrated modules to enhance parenting skills and promote effective parental responses to normal aggressive behavior in young children. The parent educational module presents a hypothetical situation of one child harming another. As the module progresses the viewer is given 20 different discipline options from which to choose. Participants are encouraged to click on all the options they wish to learn more about. The different options provide ways to respond to the situation and explain that there are discipline choices that are considered Great options, Good options after others have been tried, or There are better options. The length of the program is dependent on how many of the 20 discipline options the participant chooses to learn about, but generally it can be finished in 20-40 minutes."
15847943|NCT04059185|Other|Usual care|"Our usual care control group participants receive a resource and referral list for local social services"
15847944|NCT04059172|Drug|Ibuprofen 200 mg and acetaminphen 650 mg|"For morning appliance placement: dose #1 at approximately 9:00 a.m. as appointment starts; dose #2 6 hours later (3:00 p.m- or as soon after school and close to 3 pm as possible.); dose #3 another 6 hours later (9:00 p.m.); dose #4 the following morning upon waking (approximately 24 hours from start and patient will record the time), doses #5 through #7 will be taken every morning upon waking on the second, third, and fourth days, respectively.
~For afternoon appliance placement: dose #1 at approximately 2:00 p.m. as appointment starts; dose #2 6 hours later (8:00 p.m.); dose #3 the following morning upon waking (approximately 12 hours later and patient will record the time); dose #4 6 hours later from dose #3 (approximately 24 hours from the initial dose) around 2:00 p.m. (or as soon after school as possible) doses #5 through #7 will be taken every afternoon at 2:00 p.m. on the second, third, and fourth days, respectively."
15847945|NCT04059172|Drug|Ibuprofen 200 mg|"For morning appliance placement: dose #1 at approximately 9:00 a.m. as appointment starts; dose #2 6 hours later (3:00 p.m- or as soon after school and close to 3 pm as possible.); dose #3 another 6 hours later (9:00 p.m.); dose #4 the following morning upon waking (approximately 24 hours from start and patient will record the time), doses #5 through #7 will be taken every morning upon waking on the second, third, and fourth days, respectively.
~For afternoon appliance placement: dose #1 at approximately 2:00 p.m. as appointment starts; dose #2 6 hours later (8:00 p.m.); dose #3 the following morning upon waking (approximately 12 hours later and patient will record the time); dose #4 6 hours later from dose #3 (approximately 24 hours from the initial dose) around 2:00 p.m. (or as soon after school as possible) doses #5 through #7 will be taken every afternoon at 2:00 p.m. on the second, third, and fourth days, respectively."
15847975|NCT04058899|Device|infusion pump|infusion pump for titration of fluid containing drug infusion
15847946|NCT04059172|Drug|Placebo oral tablet|"For morning appliance placement: dose #1 at approximately 9:00 a.m. as appointment starts; dose #2 6 hours later (3:00 p.m- or as soon after school and close to 3 pm as possible.); dose #3 another 6 hours later (9:00 p.m.); dose #4 the following morning upon waking (approximately 24 hours from start and patient will record the time), doses #5 through #7 will be taken every morning upon waking on the second, third, and fourth days, respectively.
~For afternoon appliance placement: dose #1 at approximately 2:00 p.m. as appointment starts; dose #2 6 hours later (8:00 p.m.); dose #3 the following morning upon waking (approximately 12 hours later and patient will record the time); dose #4 6 hours later from dose #3 (approximately 24 hours from the initial dose) around 2:00 p.m. (or as soon after school as possible) doses #5 through #7 will be taken every afternoon at 2:00 p.m. on the second, third, and fourth days, respectively."
15847947|NCT04059159|Device|Connected Catheter|Patients will use the Connected Catheter to empty the bladder during the course of treatment.
15847948|NCT04059146|Other|Pain Education and Exercise|Participants will be randomly assigned to a pain education group, following biopsychosocial model, or standard of care education, following biomedical model. The goals of the pain education intervention are for patients to 1) address fear of movement and pain catastrophizing specific to AT, 2) learn about the neurophysiology of pain, 3) develop coping skills, and 4) promote exercise participation through pacing. This program enables patients to have a conceptual change in their understanding of what causes pain, gain greater control over the psychological aspects of pain, and reduce the perceived threat of chronic pain. Participants will be given weekly online exercises to promote engagement with the material, give individual feedback to participants, and assess understanding. In person sessions with the physical therapist will reinforce self-learning and application to a home exercise program.
15847949|NCT04059146|Other|Standard Education and Exercise|The comparison group will be given education based on standard of care resources that primarily utilize a biomedical model, which assumes that AT pain is primarily caused by tissue damage. The videos, handouts, and exercises will be equivalent to the pain education group in terms of time and learning requirements.
15847950|NCT04059133|Device|DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL EvoTronTM, GA)-Sham arm|Sham treatment (shock wave probe w/o energy)
15847951|NCT04059133|Device|DUOLITH SD1-TOP focused shock wave system (STORZ MEDICAL EvoTronTM, GA)-LiESWT arm|Low intensity extracorporeal low energy shock wave treatment (shock wave probe w/ energy)
15847952|NCT04059120|Other|Experimental group whit specific stretching|The intervention involves a reality of physical, physical, different exercise, similar to the realist of high-performance athletes. However, this is the physical load, which is reduced with specific exercises of stretching and with it the factors that determine the syndrome of overtraining
15847953|NCT04059120|Other|Control group whit out specific stretching|The intervention involves a reality of physical, physical, different exercise, similar to the realist of high-performance athletes. However, this is the physical load, which is reduced less than specific exercises of stretching and with it the factors that determine the syndrome of overtraining
15847954|NCT04059107|Device|3D Printed Myoelectric Prosthetic Device|3D Printed Myoelectric Prosthetic Device
15847955|NCT04059094|Drug|BI 1265162|Inhalation solution
15847956|NCT04059094|Drug|Placebo|Inhalation solution
15847957|NCT04059081|Drug|Obinutuzumab|"Obinutuzumab is provided as single-use vials for intravenous administration only. Obinutuzumab 1000mg fixed dose will be administered Chlorambucil would be provided as oral tablet with dose of 0.5mg/kg
~Day 1 to day 28 is considered one cycle, and cycles will be repeated every 4-weeks, until 6 cycles."
15847958|NCT04059042|Behavioral|Music Listening|Participants will have pain threshold testing while listening to silence, music, or nature sounds.
15847959|NCT04059029|Procedure|Bariatric surgery|During bariatric surgery, all patients would undergo a wedge liver biopsy under laparoscopic guidance.
15847960|NCT04059016|Other|MBC4OUD|This computer software program consists of patient-completed self reports for screening and diagnosis of opioid use disorder among primary care patients and provides web-based clinical decision support to primary care providers for provision of pharmacotherapy for opioid use disorder.
15847961|NCT04059003|Drug|Taxanes or/and anthracycline-based therapy|Taxanes or/and anthracycline-based therapy will be used in this group. That is, intravenous injection of 90 mg/m2 epirubicin (trade name: Pharmorubicin, Pfizer, Shanghai, China; drug approval number: H20100155) + 135 mg/m2 paclitaxel liposome (trade name: Taxotere, Sanofi (Hangzhou) Pharmaceutical Co., Ltd., Hangzhou, China; drug approval number: J20090104), every 3 weeks as a course of treatment. The efficacy will be evaluated every 2 courses. After the 6th course, mastectomy will be performed according to the patient's conditions.
15847962|NCT04058990|Device|Device: Paclitaxel-Coated PTCA Balloon Catheter|Percutaneous Transluminal Coronary Angioplasty
15847963|NCT04058990|Device|SeQuent Please Drug Eluting Balloon Catheter with Paclitaxel|Percutaneous Transluminal Coronary Angioplasty
15847964|NCT04058977|Other|Power training|Progressive exercise protocol with focus on velocity of movement
15847965|NCT04058964|Biological|Pegylated Recombinant Human Hyaluronidase PH20|Given SC
15847966|NCT04058964|Biological|Pembrolizumab|Given IV
15847967|NCT04058951|Other|High Animal Protein Diet (HAPD)|A diet containing 2,0 g protein per kilo body weight per day from primarily animal origin. To accommodate the high protein intake, the diet is supplemented with protein powder based on beef isolate.
15847968|NCT04058951|Other|High Plant Protein Diet (HPPD)|A diet containing 2,0 g protein per kilo body weight per day exclusively from plant origin. To accommodate the high protein intake, the diet is supplemented with protein powder based on soy isolate.
15847969|NCT04058938|Behavioral|Educational handout instrument|The handout was single-paged (front and back), and was titled Pain After Surgery: What to Expect. The handout starts with information on rating pain and expectations for control of pain, not complete absence of pain, after surgery. Mutli-modal approach to pain control is then discussed, including pharmacologic and non-pharmacologic methods that may be used for pain control by the perioperative team and postoperatively.
15847970|NCT04058938|Behavioral|Control|Standard patient counseling
15847971|NCT04058925|Device|NIRS device|Application of NIRS electrode to forehead and thenar eminence.
15847972|NCT04058912|Genetic|PTEN-AKT-FOXO3 Gene Expression|In the patient and patient control groups, 0.5 mm tissue strip will be removed for pathology from the cyst wall removed during surgery. and tissue samples will be stored in phosphate buffered saline at -80 C and PTEN-AKT-FOXO3 gene expression level will be evaluated by RT-PCR analysis.
15847976|NCT04058886|Behavioral|Telephone-delivered Mindfulness|The telephone-delivered mindfulness training intervention that will incorporate the following elements: 1) training for primary caregivers (CG) and their caregiving partner (CP) in a telephone-based mindfulness training intervention; 2) groups of up to eight participants (four CG-CP pairs) plus an instructor, on a shared telephone line; and 3) training in a 8-week, modified MBSR program, which places additional emphasis on training in the following: a) mindful experiencing, including mindfulness of feelings and body sensations; b) mindful communication, including non-verbal mindfulness, mindful listening, and mindful speaking; and c) mindful compassion for self and others. Additionally, homework assignments will involve listening to exercises on a dial-in telephone line; and assignments for CG-CP dyads (e.g. mindful listening and communication practices) as well as CG mindfulness practices in the presence of care recipients (e.g. mindful eating, and mindful listening).
15847977|NCT04058873|Drug|Levonorgestrel 1.5mg|Levonorgestrel 1.5mg for pericoital use
15847978|NCT04058860|Device|NIRS monitoring|Cerebral and somatic near-infrared spectroscopy (rScO2) measurements
15847979|NCT04058860|Device|Cox monitoring|Cerebral autoregulation monitoring
15847980|NCT04058860|Device|Sublingual microscopy|Sublingual mucosal microcirculation measurements during surgery using side dark field (SDF) imaging
15847981|NCT04058847|Other|Your Heart Forecast|1 year follow up with Your Heart Forecast and a follow-up email every 2 weeks.
15847982|NCT04058834|Drug|NNC0385-0434|Healthy volunteers and patients will receive one injection s.c. (subcutaneously, under the skin)
15847983|NCT04058834|Drug|Placebo (NNC0385-0434)|Healthy volunteers will receive one injection s.c.
15847984|NCT04058821|Diagnostic Test|Novel MRI scan - 7 days post injury|"A turbo spin-echo localiser (20 seconds)
~Single-shot echo planar diffusion tensor imaging (7 minutes)
~3D constructive interference in steady state (CISS, 6 minutes)
~Phase-sensitive inversion-recovery gradient echo with cardiac gating (4 minutes)"
15847985|NCT04058821|Diagnostic Test|Novel MRI scan - 14 days post injury|"A turbo spin-echo localiser (20 seconds)
~Single-shot echo planar diffusion tensor imaging (7 minutes)
~3D constructive interference in steady state (CISS, 6 minutes)
~Phase-sensitive inversion-recovery gradient echo with cardiac gating (4 minutes)"
15847986|NCT04058821|Diagnostic Test|Functional MRI scan - 6 months post brachial plexus exploration|"Continuous whole brain echo-planar imaging
~High-resolution T1-weighted imaging of the brain
~Bilateral magnetic resonance spectroscopy (12 minutes)"
15847987|NCT04058821|Diagnostic Test|Functional MRI scan - 12 months post brachial plexus exploration|"Continuous whole brain echo-planar imaging
~High-resolution T1-weighted imaging of the brain
~Bilateral magnetic resonance spectroscopy (12 minutes)"
15847988|NCT04058808|Other|Weight Watchers|online or in a weekly wellbeing workshop, there is a fee of £12.95 per month, this is a healthy lifestyle programme based on food items having a point attached to them depending on the calorie, fat and sugar content. Each member has a specific number of points per day to use on their meals. The healthier foods have fewer points therefore you can eat more of them.
15847989|NCT04058808|Other|Slimming world|online or in a weekly class, there is a fee of £5 per week. Free foods can be consumed freely are low fat healthy options, healthy extras (bread/milk/pulses) can be consumed in moderation. Higher fat, higher calorific foods have a number of SYNS attached, each person has a set number of SYNS (sins) per week to use as they wish.
15847990|NCT04058808|Other|Leeds 'One You'|a free weekly 1 hour class (run in various places across Leeds), a variety of topics are covered, from food labels to the Eat well guide. This eating plan is based on calorie counting.
15847991|NCT04058808|Other|NHS Choices|a free on line programme that is based on restricting calories using the Eat well guide and encouraging physical activity.
15847992|NCT04058808|Other|5:2 diet|5 days of eating normal calories (2000 Female, 2500 Male) and 2 days eating restricted 500 calories (this may be amended depending on the patient).
15847993|NCT04058808|Other|Individuals own personal plan|the participant will explain in detail their own designed plan and this will be documented on the paper records.
15847994|NCT04058795|Behavioral|Cancer Distress Coach (CaDC) App|an app that provides participants with tools to manage their stress in the moment they experience it.
15847995|NCT04058795|Behavioral|CaDC + mCoaching|The CaDC app plus weekly clinician support which provides support in navigating the app, encouraging adherence to the use of the CaDC, and providing guidance in choosing treatment strategies.
15847996|NCT04058795|Behavioral|mCBT|8 mobile sessions with a therapist to receive cognitive behavioral therapy.
15847997|NCT04058782|Other|Imaging evaluation for vascular assessment|At 1month after MI, Blood sample for total blood, plasma and PBMC collection, ECG, 3D-trans thoracic echocardiography for ventriculo-arterial coupling assessment, Vascular doppler for peripheral artery disease assessment, Arterial stiffness evaluation, Bilateral transcranial doppler for HITS evaluation
15847998|NCT04058769|Device|Premedication Guide|Software with guidelines recommendations for preoperative assessment
15848000|NCT04058743|Device|TKA with nickel free components|Patients will be randomized to receive either the standard cobalt chromium components or nickel free components
15848001|NCT04058743|Device|TKA with standard cobalt chromium components|Patients will be randomized to receive either the standard cobalt chromium components or nickel free components
15848002|NCT04058730|Procedure|Laparoscopic Roux en Y Gastric by pass surgery|
15848003|NCT04058730|Procedure|Laparoscopic Sleeve Surgery|
15848004|NCT04058730|Other|Standard Medical Management|
15848005|NCT04058717|Other|Normal Nicotine Content research cigarettes|Research cigarettes with 11.6 mg nicotine/cigarette.
15848006|NCT04058717|Other|High Nicotine e-cigarette|E-cigarette containing high nicotine e-liquid
15848007|NCT04058717|Other|Very Low Nicotine Content research cigarettes|Research cigarettes with 0.2 mg nicotine/cigarette.
15848008|NCT04058717|Other|Zero Nicotine e-cigarette|E-cigarette containing zero nicotine e-liquid
15848009|NCT04058704|Drug|Icotinib|125mg Tid/375mg per day
15848010|NCT04058704|Radiation|SRS/WBRT/HA-WBRT/SMART|>3 with WBRT/HA-WBRT/SMART or 1-3 with SRS
15848011|NCT04058691|Device|Surgical repair|Open surgery
15848012|NCT04058678|Drug|Danazol/Placebo|This group will be randomized 1:1 for either inactive substance or Danazol, according to a computer-generated randomization list prepared. Women will be treated with Danazol/Placebo oral way for 3 months.
15848013|NCT04058678|Other|Without intervention|Women with normal ovarian reserve will not be treated in anyway, thus, randomization will not be necessary.
15848014|NCT04058665|Device|Floseal|Hemostatic agent
15848016|NCT04058639|Procedure|"custom felt relief"|Felt is adjusted to the wound by cutting it in different ways and layers once every week
15848017|NCT04058639|Procedure|standard relief treatment|Felt in the shape of a letter U is put around the wound once every week.
15848018|NCT04058626|Diagnostic Test|Transcutaneous pressure of oxygen (TcPO2)|Measurements will be taken from the dorsum of the foot using an automated machine equipped with Clark electrodes.
15848019|NCT04058626|Diagnostic Test|Toe Brachial Pressure Index (TBPI)|TBPI will be measured using the photoplethysmography (PPG) method, employing an infrared sensor placed on the hallux and index finger.
15848020|NCT04058626|Diagnostic Test|Podiatry Ankle Duplex scan (PAD-scan)|Podiatry ankle duplex scan (PAD-scan) involves using an ultrasound machine to visualise the anterior and posterior tibial arteries at the ankle.
15848021|NCT04058626|Diagnostic Test|Duplex Assist|Continuous Doppler device which gives visual display of arterial spectral waveform at the ankle.
15848022|NCT04058626|Diagnostic Test|Ankle Brachial Pressure Index (ABPI)|A sphygmomanometer-cuff placed at the ankle and a handheld continuous wave Doppler device will be used to measure the systolic pressure of the DPA and PTA.
15848023|NCT04058613|Drug|ALB Protein, Human|Albumin infusions will be given at a dose of 40 g twice weekly till a steady albumin level of 4.0g/dl is reached followed by 100ml of 20% albumin at least once in two weeks to maintain a steady albumin level of 4.0g/dl along with the standard medical therapy
15848024|NCT04058613|Other|placebo|placebo
15848025|NCT04058600|Behavioral|Virtual Reality Software|Patients will be exposed to a virtual reality software that simulates the hospital environment, from admission to the operating room and the recovery room.
15848026|NCT04058587|Drug|Simmitinib|"The core trial period includes 4-weeks Screening stage (28d), 7-days single administration stage, 4-weeks multiple administration stage (28d), 3-days blood collection stage of PK after multiple administration.
~The starting dose was set at 1mg/d on toxicology data. Dosing will continue uninterrupted for 28 days in multiple administration stage.
~The dose-limiting toxicity (DLT) period assessment will be from the first administration of Simmitinib tablet to the end of the first cycle (35 days)."
15848027|NCT04058574|Device|Proprioception measurement on isokinetic dynamometer|Proprioception measurement on isokinetic dynamometer using joint position sense (JPS) and the threshold to detection of passive motion (TTDPM)
15848028|NCT04058561|Device|MAGEC® Spinal Bracing And Distraction System|The magnetically controlled growth rod (MCGR) system is a remotely distractible, magnetically controlled growing rod. The remote capabilities allow for less invasive and less time-consuming outpatient distraction visits, which solves many of the problems facing current growing rod technologies. The MCGR system allows for more frequent lengthenings, and the implanted growing rods can be lengthened more often, which allows MCGR to better approximate normal spine growth compared to Traditional Growing Rods.
15848029|NCT04058548|Diagnostic Test|Sit to stand test|Participants will complete a sit to stand test in addition to a 6 minute walk test
15848030|NCT04058535|Biological|Eylea|Aflibercept
15848031|NCT04058535|Biological|ALT-L9|Aflibercept biosimilar
15848032|NCT04058522|Other|Rotator cuff rehabilitation classes|
15848033|NCT04058522|Other|Individual Physiotherapy|
15848034|NCT04058522|Drug|Triamcinolone Injection|Subacromial Injection 40mg/1ml
15848035|NCT04058509|Combination Product|Focused shockwave therapy|3 session of shockwave therapy. The wave is focused through a standoff and transmitted into the tissue. Enhanced Energy: 0.01 - 0.55mJ/mm2. Broad Frequency Range: 1 - 8Hz. 12.5 cm penetration with pinpoint focus. The patient will be treated in the lateral decubitus position. The shock wave will focus on the area of maximal tenderness, which will be treated in a circumferential pattern.
15848036|NCT04058496|Other|Blood sampling|Five Timepoints: baseline (pre-operative), ICU admission, 4 hours after ICU admission, 8 hours after ICU admission, 48 hours after ICU admission
15848037|NCT04058483|Other|Hypnotizability testing|Hypnotizability testing in-person vs. by phone. All participants will complete both conditions.
15848038|NCT04058470|Drug|Toripalimab|Toripalimab will be administered every 3 weeks in combination with R-CHOP for 6 cycles.
15848039|NCT04058470|Drug|R-CHOP Protocol|R-CHOP regimen will be administered every 3 weeks in combination with R-CHOP for 6 cycles.
15848040|NCT04058457|Device|DBS|Patients are tested pre-operatively and the post-operatively with their implanted neurostimulators ON and OFF. DBS implantation itself is part of routine care, and not part of the study.
15848041|NCT04058444|Combination Product|ERAS protocol|No routine bowel preparation Antibiotics prophylaxis PONV (Postoperative Nausea and Vomiting) prophylaxis Spinal anesthesia Post- Cesarean analgesia (Acetaminophen 1g IV q6h, Tramadol 50mg IV q6h, Quadratus lumborum Block Oral pain relief medication Pain scores every day (VAS) Hospital length of stay Patient satisfaction
15848042|NCT04058431|Other|Osteopathic Manipulative Treatment|Osteopathic manipulative treatment (OMT) is defined as the therapeutic application of manually guided forces by an osteopathic physician to improve physiologic function and/or support homeostasis that has been altered by somatic dysfunction. Somatic (body framework) dysfunction or altered function of related components is observed in the skeletal, arthrodial and myofascial structures, and their related vascular, lymphatic, and neural elements. Techniques can use a direct method where the restrictive barrier is engaged and a final activating force is applied to correct the somatic dysfunction, or an indirect method where the restrictive barrier is disengaged and the dysfunctional body part is moved away from the restrictive barrier until tissue tension is equal in one or all planes and directions
15848043|NCT04058431|Other|Control- No Intervention|This group will refrain from getting OMT while in the study.
15848044|NCT04058418|Other|Survey Administration|Completion of a short survey.
15848045|NCT04058405|Behavioral|Observational|Cross-sectional observations
15848046|NCT04058392|Biological|Camu Camu Capsules|Camu Camu powder encapsulated (500mg each). 2 capsules per day will be used for this study
15848047|NCT04058379|Radiation|CT scan|3 ct scans : D0, D1 and D3
15848048|NCT04058366|Drug|ELX/TEZ/IVA|Fixed-dose combination (FDC) tablet for oral administration.
15848049|NCT04058366|Drug|IVA|150-mg tablet for oral administration.
15848050|NCT04058353|Drug|ELX/TEZ/IVA|FDC tablet for oral administration.
15848051|NCT04058353|Drug|IVA|Mono-tablet for oral administration.
15848052|NCT04058353|Drug|TEZ/IVA|Fixed-dose combination (FDC) tablet for oral administration.
15848053|NCT04058340|Dietary Supplement|lactizole nebulization|Lactizole is generally recognized as safe: GRAS Flavor and Extract Manufacturers Association ( numer: 3773 ) Lactizole solution for nebulization was calculated based on dose-response curves; 150ppm was chosen as minimal effective (decreased sweet taste perception) and safety ( lack of FEV1 changes after nebulization)
15848054|NCT04058340|Other|Placebo|0.9% NaCl solution in nebulization
15848055|NCT04058327|Diagnostic Test|blood ammonia test, neurophysiological/psychological tests, blood markers.|Let the patients do neuropsychological/psychological tests and use blood test for ammonia and blood markers.
15848056|NCT04058327|Drug|HE drug treatments in clinical real world|record the HE drug treatments in clinical real world if doctors use them
15848057|NCT04058314|Device|Gemini IV|Eyes randomized to receive the Gemini IV device will receive the study device in conjunction with an approved monofocal or toric IOL post cataract extraction
15848058|NCT04058314|Device|Control Eye|Control eyes will receive an approved monofocal or toric IOL post cataract extraction
15848059|NCT04058301|Other|Text message information|Geographically proximate resources delivered by text message
15848060|NCT04058288|Device|High-definition Transcranial Direct Current Stimulation|Stimulation sessions will be conducted on 2 different visits separated by 2-week gap. In a crossover design, Anodal HD-tDCS will be delivered either in Active/Sham mode (during the first visit) and Sham/Active during the second visit in a 4x1 ring configuration (center electrode being Anode and the surrounding 4 electrodes being cathodes) over the affected motor area.
15848061|NCT04058275|Other|Draw blood (phlebotomy, 83 ml)|Draw 83 ml of blood
15848062|NCT04058262|Other|Meditation presential|Facilitator-guided meditation in groups or individually, in 45-minute sessions twice a week for 2 weeks, in a quiet room with controlled light and temperature, and comfortable cushions and chairs.
15848063|NCT04058262|Other|Reiki|Reiki will be performed in 45-minute sessions twice a week for 2 weeks then in a quiet room with controlled brightness and temperature.
15848064|NCT04058262|Other|Meditation (app)|Mindfulness meditation guided through 10-15 minute audio using app, to be practiced daily at home.
15848065|NCT04058262|Other|round of conversation|The Round of Conversation will take place twice a week, lasting 45 minutes, for two weeks thereafter, at the same clinic, where women will talk about their lives, their needs, how they handle reported situations and how also your skills and preferences.
15848066|NCT04058249|Device|Accelerated intermittent theta-burst stimulation over right DLPFC|"All participants will receive accelerated intermittent theta-burst stimulation to the right DLPFC. Stimulation intensity will be standardized at 90% of resting motor threshold adjust to the skull to cortical surface distance.
~Stimulation will be delivered to right-DLPFC using the Brainsway stimulator."
15848067|NCT04058236|Other|human albumin 5%|Human Albumin 5% will be given as fluid management for this group in accordance to goal directed therapy and guided by stroke volume variation of approximately 12-15%. This percentage of SVV has been validated as a threshold above which fluid administration increases stroke volume with an area under the receiver operating characteristics curve reported at 0.87. If the SVV remains more than 15% for more than 2 minutes, 250ml of fluid replacement according to patient group will be given. These boluses are given in aliquots over 30 min to avoid effects of rapid volume expansion. and the same fluid and technique will be carried out within 24 hours intra and post operatively in the Intensive Care Unit (ICU). All clinical parameters and fluids including blood that will be given will be recorded.
15848068|NCT04058236|Other|gelofusine.|Gelofusine will be given as fluid management for this group in accordance to goal directed therapy and guided by stroke volume variation of approximately 12-15%. This percentage of SVV has been validated as a threshold above which fluid administration increases stroke volume with an area under the receiver operating characteristics curve reported at 0.87. If the SVV remains more than 15% for more than 2 minutes, 250ml of fluid replacement according to patient group will be given. These boluses are given in aliquots over 30 min to avoid effects of rapid volume expansion. and the same fluid and technique will be carried out within 24 hours intra and post operatively in the Intensive Care Unit (ICU). All clinical parameters and fluids including blood that will be given will be recorded.
15848069|NCT04058223|Device|Hemorrhoidopexy|stapled hemorrhoidopexy
15848070|NCT04058210|Drug|ELX/TEZ/IVA|Fixed-dose combination tablet for oral administration.
15848071|NCT04058210|Drug|IVA|150-mg tablet for oral administration.
15848072|NCT04058197|Drug|Deferoxamine Product|Deferoxamine Intradermal Delivery Patch
15848073|NCT04058197|Other|Placebo|Placebo Patch
15848074|NCT04058171|Diagnostic Test|Treadmill walking test|Participants will be invited to walk on a treadmill at a speed of 1,2 mph for at most five minutes for both conditions (straight walking posture and inclined walking posture). Each walking posture condition will be followed by a rest time of five minutes in sitting position. Conditions were randomized in each group using a computer-generated sequence.
15848077|NCT04058145|Drug|AMD3100|AMD3100 is a drug that inhibits a chemokine CXCR4 which promotes cancer cell growth, spread, and survival and controls immune cell trafficking. Inhibiting CXCR4 expels the immune-suppressive cells out of the tumor and attract the cancer-killing immune cells into the tumor environment so that the body's immune system may be able to better attack the cancer cells.
15848078|NCT04058145|Drug|Pembrolizumab|"Pembrolizumab is thought to block a receptor called PD-1. This receptor usually acts as a brake to prevent the body's immune system from attacking cancer cells. The antibody removes the brake to allow parts of the body's immune system (usually T cells) to attack the tumor."
15848079|NCT04058132|Drug|Sildenafil Citrate 50Mg Tab|sildenafil citrate (Viagra®, Pfizer. Inc., NY, NY). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1Hpyrazolo[4,3-d]pyrimidin-5-yl)-4- ethoxyphenyl]sulfonyl]-4-methylpiperazine citrate. Sildenafil citrate is a white to off-white crystalline powder with a solubility of 3.5 mg/mL in water and a molecular weight of 666.7. For this study, we will use 50 mg tablets for the single dose studies.
15848080|NCT04058132|Device|functional Near-infrared Spectroscopy (fNIRS)|Functional Near-Infrared Spectroscopy (fNIRS): Functional near-infrared spectroscopy (fNIRS) a noninvasive technique that can measure cerebrovascular reactivity (CVR) will be used to measure regional cerebral blood flow and cerebrovascular reactivity in the brain. The device (fNRIS100, fNIR Device LLC), uses laser emission diodes (730nm and 850nm)which in a headband that is worn on the front of the scalp and forehead. Surrounding detectors a few centimeters away detect the light as it scatters through the underlying tissues. The technique is able to detect changes in the absorption spectrum of the tissue corresponding to the concentrations of oxyhemoglobin (HbO2) and deoxyhemoglobin (HbR), and indicate local perfusion changes. fNIRS will be performed twice at each study visit, once before and once about 45 minutes after single dose administration of sildenafil 50 mg.
15848081|NCT04058132|Other|Carbon Dioxide (CO2) 5%|"Carbon Dioxide (CO2) 5% mixed with room air. Both the fNIRS procedure and one Magnetic Resonance Imaging (MRI) session at visits that include imaging will be done with a hypercapnia challenge for comparison.
~CO2 (hypercapnia) challenge is similar to holding one's breath. Participant will wear a nose clip and a mouth breathing apparatus while in the MRI scanner or sitting in a chair during the fNIRS procedure.
~During the 7-minute hypercapnia procedure, participants will breathe room air and then switch to room air mixed with 5% CO2, from one to the other for one minute each."
15848082|NCT04058132|Other|Neuropsychological Assessments|TBI Neuropsychological Assessments: Study participants will be administered a set of Neuropsychological Tests designed by the NINDS Common Data Elements (CDEs) initiative for TBI, in order to provide a comprehensive and broad assessment of deficits commonly found after TBI. We anticipate that the neuropsychological battery will require approximately 1 hour to complete. The measures (pencil and paper exercises, questionnaires, and interview by the examiner) to be administered are: Glasgow Outcome Scale-Extended (GOS-E). Learning trials portion of the California Verbal Learning Test (CVLT-II): The Trail Making Tests A and B (TMT): Subsets of the Wechsler Adult Intelligence Scale (WAIS-IV) (Digit Symbol and Symbol Search): Behavioral Symptoms Inventory-18: Satisfaction with Life Scale (SWLS): Word Reading subtest of Wide Range Achievement Test (WRAT)-4: Rivermead Post-Concussion Symptom Questionnaire.
15848083|NCT04058132|Drug|Gadolinium contrast infusion|Gadolinium contrast infusion: Brain MRI with gadolinium contrast: Dynamic contrast-enhanced (DCE) MRI with intravenous gadolinium-based contrast agents (GBCAs) to measure their transfer rate between intravascular and extravascular compartments as a marker of blood-brain barrier (BBB) permeability. For the DCE sequence, the participant is injected with the contrast agent through a heplock/iv in the scanner and the sequence takes about 15 min. Half-life of gadolinium is about 1 ½ hours and 90-98% clearance from the body in 24 hours in people with normal kidney function.
15848084|NCT04058132|Procedure|Blood sample collection for research purposes|Serum and plasma (5 ml each) will be collected at at each study visit 10 m or 2 tsp. per visit or up to 40 ml or 8 tsp. over the 180 day course of the study). Samples will be collected by study personnel.
15848085|NCT04058132|Other|Structural brain Magnetic Resonance Imaging (MRI|"Structural brain Magnetic Resonance Imaging (MRI): The scanner used is a 3.0 Tesla MR (Model 750, General Electric Healthcare), which is equipped with a high-performance gradient subsystem and a 32-channel head coil (General Electric Healthcare). These scans involve lying still in a scanner for several minutes at a time which is tube shaped, using magnetism to take images of the brain. There is no radiation in MRI. The participants will have up to 3 research brain MRIs. Healthy controls will have 1 MRI session.
~Common TBI MRI techniques will be performed. Block-design BOLD fMRI during which there will be a 7 minute hypercapnia challenge will be done to assess brain blood flow and measure cerebral vascular reactivity (CVR)."
15848086|NCT04058119|Behavioral|Mind-body therapies|Sessions of body-mind therapies (yoga, qigong and pilates), oriented by certified instructors. Every sessions will be 60-minutes long, biweekly, with a total duration of 6 months.
15848087|NCT04058106|Procedure|A patient who need the cerebral artery aneurysm clipping surgery|A patient who go the propofol based total intravenous anesthesia due to intraoperative neuromonitorung for unruptured cerebral artery aneurysm clipping surgery
15848088|NCT04058093|Behavioral|Functional Training Program|"Functional training program (FTP) include:
~Functional training sessions will be oriented by graduates or masters in sport with the supervision of a sports medicine doctor;
~Group nutrition counseling, in the form of healthy cooking classes direct by nutritionists with the support of culinary students."
15848089|NCT04058080|Other|Bikram Yoga|Participants in the Bikram yoga group were asked to attend two classes per week for 8 weeks (16 classes in total) at a local affiliated Bikram yoga studio. Certified Bikram yoga teachers instructed all classes using a scripted instructional dialogue. Each 90-min class was held in a temperature-controlled room (40.6C, 40% humidity). The yoga studio regularly offered 22 class times per week, all of which were accessible to participants.
15848090|NCT04058080|Other|Aerobic Exercise|Participants in the aerobic exercise group were asked to attend two group aerobic exercise classes per week for 8 weeks (16 classes in total) at the Kingston Family YMCA. They were provided with a modified schedule of the YMCA group classes, which included only classes with a strong aerobic component and excluded those involving yoga, pilates, or cycling. Classes involving the following components were available to participants: choreography-based cardio, aerobics, light muscular conditioning, and stretching; cardio, plyometric, and strength training exercises; high intensity aerobic exercise with intermittent rest periods; circuit-based cardio and strength training exercises; stepper-based exercises; and Latin-inspired dance/fitness. Classes were 50-60 minutes in duration. Participants were able to attend any of the offered classes each week. Participants had approximately 18-22 classes in total to choose from each week.
15848091|NCT04058067|Drug|Brolucizumab|5 x every 6 weeks loading then every 12 weeks or every 8 weeks maintenance
15848092|NCT04058067|Drug|Aflibercept|5 x every 4 weeks loading then every 8 weeks maintenance
15848093|NCT04058054|Device|KeraStat® Cream|Administered 0.025 gm of KeraStat Cream per subject on day 1 of the study.
15848094|NCT04058054|Device|KeraStat Gel|Administered 0.025 gm of KeraStat Gel per subject on day 1 of the study.
15848095|NCT04058054|Device|Biafine|Administered 0.025 gm of Biafine per subject on day 1 of the study.
15848096|NCT04058054|Drug|Histamine|Administered 1 drop of Histamine Dihydrocl (6 mg/mL) per subject on day 1 of the study.
15848097|NCT04058054|Drug|Saline (0.9% NaCl)|Administered 1 drop of saline per subject on day 1 of the study.
15848098|NCT04058041|Procedure|Neural Mobilization|neural exercise Will be performed in the patients
15848099|NCT04058041|Procedure|Surgery|open or endoscopic surgery will be permed in the patients with tunnel carpal syndrome
15848100|NCT04058041|Procedure|Surgery and neural mobilization|following the surgery patients will be treat with neural mobilization exercises.
15848101|NCT04058028|Drug|Rozibafusp Alfa|Rozibafusp Alfa will be presented in 5 mL glass vial
15848102|NCT04058028|Drug|Placebo for Rozibafusp Alfa|Placebo for Rozibafusp Alfa will be presented in 5 mL glass vial
15848103|NCT04058015|Other|Stress-induced hyperglycemia|Stress-induced hyperglycemia (SIH)was defined as a serum glucose ≥ 200 mg/dL in the patients without Diabetes mellitus.
15848104|NCT04058015|Other|Diabetic hyperglycemia|Diabetic hyperglycemia (DH) which indicated a serum glucose ≥ 200 mg/dL in patients with Diabetes mellitus.
15848105|NCT04058015|Other|Diabetic normoglycemia|Diabetic normoglycemia (DN), which was defined when there was a serum glucose < 200 mg/dL in the patients with Diabetes mellitus.
15848106|NCT04058015|Other|Non-diabetic normoglycemia|Non-diabetic normoglycemia (NDN) indicating a serum glucose < 200 mg/dL in patients who were absent of Diabetes mellitus.
15848107|NCT04058002|Other|Multiprofessional treatment and Educational Program Associated (EPA+C+BCAA) with supplementation of creatine and BCAA.|17 patients will participate in two days of lectures two-months apart on the subject of knee OA, but will also come to the hospital at months 1, 3 and 5 after the first class to consult about nutritional habits to be improved; at months 4 and 6 to participate in a group therapy session with the psychologists, 7 sessions with the physical therapy team followed by 7 sessions with the physical educators team (once a week/4 weeks and once every two weeks, three times). Patients will be supplemented with creatine 5 grams and maltodextrin 100g, 30 minutes before training. At breakfast they will also ingest 5 grams of BCAA (1,200 milligrams of leucine, 600 milligrams of isoleucine and 600 milligrams of valine per dose)
15848108|NCT04058002|Other|Multiprofessional treatment and Educational Program Associated (EPA+C) with supplementation of creatine only.|17 patients will participate in two days of lectures two-months apart on the subject of knee OA, but will also come to the hospital at months 1, 3 and 5 after the first class to consult about nutritional habits to be improved; at months 4 and 6 to participate in a group therapy session with the psychologists, 7 sessions with the physical therapy team followed by 7 sessions with the physical educators team (once a week/4 weeks and once every two weeks, three times). Patients will be supplemented with creatine 5 grams and maltodextrin 100g, 30 minutes before training. At breakfast they will also ingest 5 grams of placebo.
15848109|NCT04057989|Drug|ketamine|
15848110|NCT04057976|Diagnostic Test|Probabilistic diffusion tensor tractography|Patients enrolled in this study will undergo probabilistic diffusion tensor tractography (additional MRI sequence) preoperatively in order to determine whether this it is possible to determine the course of the facial nerve.
15848111|NCT04057963|Other|Conventional plus Functional Inspiratory Muscle Training Group|functional inspiratory muscle training is an exercise program that practises gradual training of the diaphragm muscle.
15848112|NCT04057963|Other|Conventional Physiotherapy Program|conventional physiotherapy is a treatment program consisting of evidence based modalities as mobilization and specific exercises.
15848113|NCT04057950|Other|cosmetic product|Disulfure de sélénium versus placebo formula
15848114|NCT04057937|Drug|Apremilast|Apremilast
15848115|NCT04057937|Drug|Placebo|Placebo
15848116|NCT04057924|Other|abstention from CIN2 treatment and surveillance for at least 2 years|Non-interventional monocentric prospective study taking place at the Bordeaux University Hospital where women with a CIN2 meeting the eligibility criteria will benefit from abstention from treatment and surveillance for at least 2 years
15848117|NCT04057911|Device|Active NIBS|Cathodal noninvasive brain stimulation will be given for 20 mins.
15848118|NCT04057911|Device|Sham NIBS|The electrode placement will be same, but the electric current will be ramped down 5 seconds after the beginning of the stimulation
15848119|NCT04057898|Drug|MN-166|Subjects will take MN-166 for 12 months followed by a 6-month open-label extension phase.
15848120|NCT04057898|Drug|placebo|Subjects will take matching placebo for 12 months followed by a 6-month open-label extension phase.
15848121|NCT04057885|Device|Orthosensor™ VERASENSE™ Knee System|A group of patients will receive a total knee arthroplasty using the Orthosensor device
15848122|NCT04057872|Procedure|Therapeutic plasma exchange|The removed plasma is 'exchanged or replaced' with either IV fluids, albumin, and/or Fresh frozen plasma
15848123|NCT04057846|Device|EUS guided transgastric drainage|Whenever possible, randomisation and intervention shall be postponed until 4 weeks after onset of pancreatitis in line with international guidelines. All procedures in this study shall be performed by three experienced endoscopists (PNS, EFH, SN), who all have an extensive experience in endoscopic ultrasound (EUS-) guided drainage of pancreatic collections and the use of self-expanding stents. They have together performed more than 300 endoscopic, transmural drainage and debridement procedures in patients with WON since 2005. Endosonography-guided, transgastric drainage of the WONs shall be performed using a curve-linear echoendoscope (endoscope: Olympus GF-UCT180; ultrasound scanner: Hitachi Arietta 850 or Olympus EU-ME2). All collections shall be treated by single tract transmural cystogastrostomy (single-gate technique). T
15848124|NCT04057833|Drug|E-CEL UVEC|Local implantation of E-CEL UVEC cells at the supraspinatus tendon repair site
15848125|NCT04057820|Other|Finnegan Neonatal Abstinence Scoring Tool|The FNAST is a scoring system used in neonatal units to initiate and guide therapy in infants of opiate-dependent mothers.
15848126|NCT04057820|Other|Eat, Sleep, Console (ESC) care tool|The ESC care approach emphasizes parental involvement, simplifies the assessment of infants with NOWS and focuses interventions on non-pharmacologic therapies.
15848127|NCT04057807|Drug|LPS|LPS (0.4 ng/kg)
15848128|NCT04057794|Device|Lab Assay for seven genetic variants for Parkinson's Disease|Counseling provided to participant by site clinician/physician/genetic counselor.
15848129|NCT04057794|Device|Lab Assay for seven genetic variants for Parkinson's Disease|Counseling provided to participant by centralized genetic counseling group at Indiana University.
15848223|NCT04056975|Biological|Recombinant Anti-CD19m-CD3 Antibody Injection|Intravenous Infusion
15848130|NCT04057781|Procedure|Dry Needling (DN)|One to three filament needles (similar to an acupuncture needle) with no medication will be inserted into the trigger point(s) of the muscle. The needles will be repositioned a few times to make the muscle twitch (local twitch response). After several twitches occur, the researcher will leave the needles as they are, and the subject will lie on a treatment table without moving arms or head, for 10 minutes. After 10 minutes the needles are removed and discarded.
15848131|NCT04057781|Procedure|Dry needling with Intramuscular electrical stimulation (DNES)|One to three filament needles (similar to an acupuncture needle) with no medication will be inserted into the trigger point(s) of the muscle. The needles will be repositioned a few times to make the muscle twitch (local twitch response). After several twitches occur, the researcher will leave the needles as they are, and attach alligator clips to the needles to provide electrical stimulus for 10 minutes while the subject lies on a treatment table without moving arms or head. After 10 minutes, the electrical stimulus will be turned off and detached, and the needles removed and discarded.
15848132|NCT04057768|Device|Venus Viva|The Venus Viva™ fractional RF device has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.
15848133|NCT04057755|Drug|botulinum toxin A|
15848134|NCT04057755|Drug|NaCl|
15848135|NCT04057742|Diagnostic Test|AlloSure ddcfDNA assay|2.5 mL collection for Donor Derived Cell Free DNA at transplant, 3 weeks, 6 weeks, 6 months, 12 months, 24 months post-transplant for Group A, at transplant for Group B, and transplant ans 3 months for Group C
15848136|NCT04057742|Diagnostic Test|AlloMap assay|10 mL collection PAXgene blood sample at transplant, 3 weeks, 6 weeks, 6 months, 12 months, 24 months post-transplant for Group A, at transplant for Group B, and transplant ans 3 months for Group C
15848137|NCT04057742|Diagnostic Test|Inflammatory Cytokines|10 mL collection at transplant, 3 weeks, 6 weeks, 6 months, 12 months, 24 months post-transplant for Group A
15848138|NCT04057742|Diagnostic Test|Immune Cell Phenotypes|Collection of up to 1 cup of urine for per participant each study visit
15848139|NCT04057729|Drug|IMP4297|10mg/capsule.
15848140|NCT04057716|Behavioral|Sleep restriction|Participants will be asked to restrict their sleep by 1.5 hours each night for one week.
15848141|NCT04057716|Behavioral|Sleep extension|Participants will be asked to extend their sleep by 1.5 hours each night for one week.
15848142|NCT04057677|Behavioral|Bed Rest Intervention|The participant will remain in bed rest for 10 days at the clinical research unit at TRI, AdventHealth, Orlando.
15848143|NCT04057677|Behavioral|Exercise Program|During the first 4 weeks following bed rest, participants will perform a combination of aerobic and resistance exercise training with a certified exercise physiologist 3 days per week at the TRI exercise training facility.
15848144|NCT04057664|Behavioral|Learning of Coping Strategies|Group sessions with psychotherapy and physiotherapy
15848145|NCT04057638|Procedure|Combined Craniomaxillofacial and Upper Extremity Allotransplantation|Combined Craniomaxillofacial and Upper Extremity Allotransplantation
15848146|NCT04057625|Device|transthoracic ultrasound|using transthoracic ultrasound in the diagnosis and follow up of vap,measuring the largest area of consolidation according to intercostal space and the direction of the probe.
15848147|NCT04057612|Other|Esophagus temperature monitoring|Measuring core temperature by esophageal stethoscope
15848148|NCT04057612|Other|Carotid artery temperature monitoring|Measuring temperature on skin near to carotid artery using 3M™ Bair Hugger™ temperature monitoring system
15848149|NCT04057586|Procedure|Nonintubated|During surgery, patient is deeply sedated and respiration is maintained by spontaneous breath under the nasal high flow oxygen support.
15848150|NCT04057586|Procedure|Intubated|During surgery, patient received standard general anesthesia and respiration is maintained by using mechanical ventilation.
15848151|NCT04057573|Drug|Ruxolitinib cream|Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
15848152|NCT04057573|Drug|Vehicle|Vehicle cream is a topical formulation applied as a thin film to affected areas.
15848153|NCT04057547|Drug|Modified Gegen Qinlian Decoction|Modified Gegen Qinlian Decoction contains Pueraria lobata 24g, Scutellaria baicalensis 9g, Coptis chinensis 9g, artillery ginger 9g, talc 9g, roasted licorice 6g, and granules are prepared according to 10:1 production process.
15848154|NCT04057534|Behavioral|Standard therapy for AUD plus Chess-based cognitive treatment|"Behavioral: standard AUD Cognitive Behavioral Therapy (CBT) in Clinical setting.
~Patients who voluntarily submit to enter a qualified detoxification treatment program will be examined, either in-patient, out-patient, or in a day-clinic setting at the Department of Addictive Behaviour and Addiction Medicine. Additional, the experimental group receives chess based cognitive remediation treatment (CB-CRT) for 1,5 hours three times a week. The tasks of the treatment were created by our cooperation partner, the psychologist Juan Antonio Montero. He is currently successfully applying this battery as an add-on therapy. The training battery is designed to strengthen cognitive functioning in specific domains such as short-term memory, focal attention, selective attention, pattern recognition, visuospatial abilities, metacognition and also inhibition."
15848155|NCT04057534|Behavioral|Standard therapy for AUD|Behavioral: standard AUD Cognitive Behavioral Therapy (CBT) in Clinical setting. Patients who voluntarily submit to enter a qualified detoxification treatment program will be examined, either in-patient, out-patient, or in a day-clinic setting at the Department of Addictive Behaviour and Addiction Medicine.
15848156|NCT04057534|Behavioral|Standard smoking cessation therapy for TUD plus Chess-based cognitive treatment|"Behavioral: standard smoking cessation therapy for TUD in group therapy setting.
~Patients who voluntarily submit to enter a qualified smoking cessation program will be examined in an out-patient setting at the Department of Addictive Behaviour and Addiction Medicine. They receive a six-week standard therapy (one 1,5 hours group therapy per week). Additional, the experimental group receives chess based cognitive remediation treatment (CB-CRT) for 1,5 hours three times a week. The tasks of the treatment were created by our cooperation partner, the psychologist Juan Antonio Montero. He is currently successfully applying this battery as an add-on therapy. The training battery is designed to strengthen cognitive functioning in specific domains such as short-term memory, focal attention, selective attention, pattern recognition, visuospatial abilities, metacognition and also inhibition."
15848224|NCT04056962|Drug|Tacrolimus ointment|topical application of tacrolimus for treatment of superficial Kaposiform hemangioendothelioma (KHE) and tufted angioma (TA).
15848157|NCT04057534|Behavioral|Standard therapy for TUD|"Behavioral: standard smoking cessation therapy for TUD in group therapy setting.
~Patients who voluntarily submit to enter a qualified smokind cessation program will be examined in an out-patient setting at the Department of Addictive Behaviour and Addiction Medicine. They receive a six-week standard therapy (one 1,5 hours group therapy per week). Additional, the experimental group receives chess based cognitive remediation treatment (CB-CRT) for 1,5 hours three times a week."
15848158|NCT04057521|Other|Care Coordination|Comprehensive care coordination.
15848159|NCT04057508|Other|Modulation of muscle sympathetic nerve activity|Assessment of muscle sympathetic nerve signal and exposition to external non invasive modulation.
15848160|NCT04057495|Other|further fasting|2 hours of fasting
15848161|NCT04057495|Other|white bread consumption|113 grams of white bread consumption
15848162|NCT04057495|Other|mango consumption|330 grams of mango consumption
15848163|NCT04057482|Drug|D|treatment of BV with dequalinium chloride vaginal tablets
15848164|NCT04057469|Drug|Tulobuterol Hydrochloride|Participants received tulobuterol patch 7 to 8 hours before the anesthetic induction
15848165|NCT04057469|Drug|Placebo transdermal patch|Participants received placebo patch 7 to 8 hours before the anesthetic induction
15848166|NCT04057456|Other|Placebo diet|"The dietitian will assist in developing a diet that is isocaloric to the anti-inflammatory diet and healthy (for the sake of the participants' well-being, and to blind participants), while allowing many foods that are (counterintuitively) pro-inflammatory (e.g. whole wheat bread, white beans, oats, soy, eggplant, raspberries, pumpkin seeds, popcorn, etc). Occasional cheat foods are built into the placebo diet but with more pro-inflammatory options (e.g. two glasses of wine per week)."
15848167|NCT04057456|Other|Anti-inflammatory diet|"Participants will also be given a list of foods that they are allowed on the anti-inflammatory diet, and a list of foods to avoid so that they can make informed substitutions to the meals and ingredients that they are given. The study participants will be given a one-week meal plan with accompanying recipes. Occasional cheat foods are built into the anti-inflammatory diet (e.g. two bottles of beer per week)"
15848168|NCT04057456|Drug|Nabilone Capsules|Capsules will be 0.5mg nabilone. Participants will undergo an 8-week titration period by taking 1 (0.5mg) nabilone capsule per day for a one-week period. The dose will be increased on a fixed schedule by 1 (0.5mg) capsule each week to a maximum of 8 capsules/day (4mg). Dosage will be maintained if higher doses are not tolerated or if sufficient relief is obtained (at least a 2-point change on the NRS). Once the appropriate nabilone (or placebo) dosage for each participant is determined, participants will begin their respective interventions over the course of the 12-week treatment period.
15848169|NCT04057456|Other|Placebo capsules|Placebo capsules contain no active ingredient. Participants on placebo capsules will undergo the same 8-week titration period and intervention period as those on active treatment.
15848170|NCT04057443|Other|Nutritional support|Nutritional support will be given to all patients according with their nutritional body composition parameters (Nutritional assessment and sarcopenia evaluation). It could be diet counselling, oral supplemented nutrition, enteral nutrition o parenteral nutrition.
15848171|NCT04057443|Other|Physical exercise|The exercise program, designed, applied and monitored by research staff of the Physiology Unit, will have duration of 24 weeks (6 months). The program will have a mixed structure, the participants in an individual way fulfill their training and attend group sessions (8 subjects). In addition, 3 days a week should conduct sessions that will focus on the work of balance and general strength.
15848172|NCT04057443|Drug|Hematologic Drug|The patients of the control group will follow the standard treatment and follow-up according to the clinical protocol of the institution.
15848173|NCT04057430|Device|GumChucks|GumChucks® is an innovative flossing system resembling mini nunchucks. The two-handle design eliminates the need to wrap the floss around fingers, and a proper flossing technique is facilitated by the nature of its curved shaped.
15848174|NCT04057430|Device|String floss|Traditional string floss used in this study was Oral-B Glide® Pro-Health Original Floss
15848175|NCT04057417|Other|Urban Trail|A newly built urban trail that was part of a large policy/infrastructure investment from the city/province to enhance the built environment for active transport and recreational physical activity in the city of Winnipeg, Manitoba Canada between 2010 and 2012.
15848176|NCT04057404|Device|Alivecor Heart Monitor|
15848177|NCT04057391|Diagnostic Test|QT Scanner|Diagnostic test that is repeatable, non-invasive imaging tool for the early and accurate detection of breast cancer, breast abnormalities, and musculoskeletal findings. Comparing with mammography, the QT Scanner uses harmless soundwaves to screen and diagnose the breast.
15848178|NCT04057378|Device|Electroconvulsive therapy|Electrically induced convulsion under anesthesia
15848179|NCT04057365|Drug|Nivolumab|Nivolumab is believed to work by attaching to and inhibiting a specific protein in the cancer that controls parts of the immune system (the system in the body that fights off infections and diseases) by shutting down certain immune responses. The investigators believe that nivolumab will inhibit the protein, thus allowing the immune cells to recognize and destroy cancer cells.
15848180|NCT04057365|Drug|DKN-01|DKN-01 is believed to work by attaching to and inhibiting (stopping) a specific pathway in the cells that is responsible for processes such as cell growth
15848181|NCT04057352|Device|Citadel Embolization Device|The Citadel Embolization Device is intended to endovascularly obstruct or occlude blood flow in intracranial aneurysms.
15848182|NCT04057339|Behavioral|Time Restricted Feeding + Standard of Care|Participants in this arm will adhere to a daily, consistent 10-hr eating window for the course of the study as well as receive nutritional counseling from the study dietitian.
15848183|NCT04057339|Behavioral|Standard of Care|Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 10-hr eating window.
15848184|NCT04057326|Drug|Oryz-Aspergillus Enzyme and Pancreatin Tablet|2 tablets/time, 3 times daily,Oral Administration.
15848185|NCT04057326|Drug|Placebo|2 tablets/time, 3 times daily,Oral Administration.
15848186|NCT04057313|Dietary Supplement|Coffee|Coffee used will be the boiled unfiltered Arabica coffee
15848187|NCT04057300|Drug|Ticagrelor 90mg|Ticagrelor tablet
15848188|NCT04057300|Drug|Clopidogrel 75mg|Clopidogrel tablet
15848189|NCT04057300|Drug|acetylsalicylic acid (ASA) 81mg|acetylsalicylic acid tablet
15848190|NCT04057287|Other|No intervention|No intervention
15848191|NCT04057274|Other|Exercise assessment|The moderate-intensity aerobic interval exercise will be performed on a cycle ergometer under the supervision of trained staff in an exercise science laboratory. Participants will perform a 5 to 10-minute warm-up that begins by pedalling against a light resistance (60 W) and progressively increases in resistance until a target heart rate of 50-60% heart rate reserve is achieved. Participants will then complete 6 x 5-minute bouts at 60% heart rate reserve whilst maintaining a cadence of 60 rev·min-1, separated by 2.5-minutes of pedalling against light resistance (60 W). The session will finish with a cool-down at light resistance (60 W) lasting 10-minutes.
15848192|NCT04057261|Drug|Liraglutide Pen Injector [Victoza]|Increasing dose of Liraglutide: 0.6 mg/d for the first week, 1.2 mg/d for the second week aiming for a maximum of 1.8 mg/d beginning with the third week (or highest tolerated dose).Subcutaneous injection once daily via pre-filled pen
15848193|NCT04057261|Drug|Placebo|Matching Placebo once daily, subcutaneous injection via pre-filled pen.
15848194|NCT04057248|Device|Dario Blood Glucose Monitoring System|Dario Blood Glucose Monitoring System (BGMS) with Dario App and Dario digital platform
15848195|NCT04057248|Behavioral|CDE|Certified Diabetes Educator Sessions
15848196|NCT04057235|Device|FlareHawk Interbody Fusion System|Expandable lumbar intervertebral body fusion device
15848197|NCT04057222|Other|No intervention|Only propose water and wait for need to void
15848198|NCT04057209|Radiation|Single Vocal Cord Irradiation (SVCI)|The following planning aim will be pursued: full coverage of the PTV with at least 95% of the prescribed dose and a maximum (0.03 cc) PTV dose of <107%: 16 x 3.63 = 58.08 Gy in 5 fractions per week using 5 to 9 static IMRT or VMAT.
15848199|NCT04057209|Procedure|Arm A: Transoral CO2-Laser Microsurgical Cordectomy (TLM)|"The TLM has to be performed using a CO2 laser, coupled to an operative microscope, at 4-8W in ultrapulse mode. The type of cordectomy performed must be mentioned using the following classification according the classification of the European Laryngological Society.
~The type of resection chosen should provide complete removal of the primary lesion with negative margins.
~Surgery will generally be performed within 3 weeks after randomization and not more than 6 weeks after panendoscopy.
~The extent of the cordectomy must include a complete anterior, posterior, inferior and supero-lateral mucosal and deep soft tissue margin."
15848200|NCT04057196|Behavioral|Self-System Therapy for Older Adults with Advanced Lung Cancer (SST-LC)|The SST-LC is a brief structured intervention deliverable by video conference. The new SST-LC protocol will incorporate behavioral strategies designed to meet the needs of older adults with lung cancer, including examining individual and shared expectations for lung cancer care, identifying discrepancies between expectations and realistic possibilities, and modifying stress-exacerbating behaviors.
15848201|NCT04057183|Diagnostic Test|Carotid Stenotic Scan|Noninvasive determination of presence or absence of carotid artery stenosis
15848202|NCT04057170|Other|accelerated protocol and mulligan method|manual therapy technic
15848203|NCT04057157|Device|Biodesign Dural or Duraplasty Repair Grafts|Patients will receive the Biodesign Dural or Duraplasty Repair Grafts according to the Instruction for Use.
15848204|NCT04057144|Behavioral|ACT|Acceptance and commitment therapy (ACT) sessions, lead by 2 qualified therapists, using a manual based on Steven Hayes et al 1999 that was adapted to group therapy and includes all the dynamic processes of ACT.
15848205|NCT04057144|Behavioral|mindfulness exercises and audio recordings|mindfulness exercises introduced in the ACT sessions. In addition daily home meditation exercises based on the program developed by Kabat-Zinn 2005 and with help of audio recordings.
15848206|NCT04057144|Behavioral|Education program|"Self-management education program. Information given by a qualified health professional on pain and symptom management, stress, sleep, eating habits, mental health problems. Group discussions about thoughts and experiences.
~communication skills and physical activity"
15848207|NCT04057131|Drug|Firazyr|Participants with Hereditary angioedema (HAE) receiving treatment with Icatibant acetate (Firazyr) as prescribed by their physician following locally approved prescribing information.
15848208|NCT04057118|Drug|SKI-O-703|Oral administration, twice per day
15848209|NCT04057118|Drug|Placebo|Oral administration, twice per day
15848210|NCT04057092|Dietary Supplement|Dietary Supplement INergy-FLD|INergy-FLD® is an immune modulating formula containing various ingredients including L-Arginine, whey protein isolate, and omega-6 fatty acid, aimed to attenuate excessive inflammatory responses without being immunosuppressive and to replenish nutrients that are depleted in a state of surgical stress, thereby enhancing the recovery process and decreasing the risk of infection. The volume of the beverage is 250mL per serving and patients will be asked to consume 3 servings periodically per day for 5 days prior to surgery and 5 days following surgery.
15848211|NCT04057079|Combination Product|Anugel, Hydrogel sponge|A calibrated sponge impregnated with hydrogel is inserted to the rectum post hemoroidectomy.
15848212|NCT04057079|Combination Product|Gelatine Sponge|A gelatine sponge is inserted in to the rectum pos hemoroidectomy.
15848213|NCT04057066|Behavioral|Physical activity counseling|Physical activity counseling consists of two phone or video calls with a therapists, two group video calls with a therapist and a complementary e-learning course.
15848214|NCT04057066|Behavioral|Exercise|Participants will agree with their therapist on an exercise plan (endurance and resistance training) that will be made available through the studies mobile app. Frequency and duration of endurance and strength training shall be prescribed in accordance with exercise guidelines for pwMS. However, they can be adjusted according to participants prior physical activity level and their available time slots for exercise during the week.
15848215|NCT04057053|Drug|Netarsudil 0.02% Ophthalmic Solution|Use of Netarsudil 0.02% ophthalmic solution daily after surgery
15848216|NCT04057040|Drug|PTG-300|Active
15848217|NCT04057040|Drug|Placebo|Placebo
15848218|NCT04057027|Procedure|Delayed umbilical cord clamping|During the C section, infants' umbilical cord clamping will be delayed for 30-60 seconds.
15848219|NCT04057027|Procedure|Cord Milking|Umbilical cord will be milked from th distance of 20cm from mother's side to the baby, for 3-4 times.
15848220|NCT04057014|Drug|Amoxicillin|Antibiotic given at different dosages and durations.
15848221|NCT04057014|Procedure|Tooth extraction|Removal of infected tooth on first day of study, this approach does not require an antibiotic drug.
15848222|NCT04056988|Drug|Perflutren Lipid Microsphere|Perflutren lipid microsphere preparation is an ultrasound contrast agent. Ultrasound contrast agents are used to help provide a clear picture during ultrasound.
15848225|NCT04056949|Drug|Paclitaxel/Albumin-Bound Paclitaxel|Paclitaxel 175mg/m2 IV on day 1of 21 days cycle ;Number of Cycles: 4-6; or Albumin-bound paclitaxel 130mg/m2 IV on day 1 and 8 of 21 days cycle ;Number of Cycles: 4-6;
15848226|NCT04056949|Drug|IBI308|IBI308 200mg IV infusion, every 3 weeks,until disease progress or intolerable toxicity,used up to 1 year (or 16 cycles)
15848227|NCT04056936|Procedure|Frenotomy|To map the severity determining any possible consequences a tongue-tie may have for breastfeeding and infant nutrition we will follow-up a cohort of tongue-tied infants to register if the feeding, growth, thriving and speech of the infant/child is affected by a tongue-tie.
15848228|NCT04056923|Procedure|3D-printing guided|3D printed navigational template guided
15848229|NCT04056923|Procedure|CT-guided|CT-guided
15848230|NCT04056923|Drug|Indocyanine Green|The results are shown by comparison of different colors.
15848231|NCT04056923|Drug|Methylene blue|The results are shown by comparison of different colors.
15848232|NCT04056923|Procedure|Preoperative|Preoperative localization.
15848233|NCT04056923|Procedure|Intraoperative|Intraoperative localization.
15848234|NCT04056910|Drug|ivosidenib and nivolumab|"Ivosidenib will be administered orally at a dose of 500 mg (provided as 250 mg strength tablets) daily. The dose may be reduced to 250 mg for patients experiencing more than one event of Grade 2 nausea or vomiting (related or unrelated), or Grade 3 or Grade 4 adverse events.
~Nivolumab will be administered at 480 mg IV every 28 days."
15848235|NCT04056897|Biological|BCD-132, 125 mg|IV infusion every 24 weeks in combination with placebo tablet daily. The total duration of blinded therapy is 100 weeks (a total of 5 cycles of therapy BCD-132 in combination with a daily placebo)
15848236|NCT04056897|Drug|Teriflunomide|14 mg teriflunomide tablet. Per os. Daily in combination with IV placebo. The total duration of blinded therapy is 100 weeks (a total of 5 cycles of placebo IV therapy in combination with daily administration of teriflunomide)
15848237|NCT04056897|Drug|Placebo|intravenous infusion in combination with placebo tablet daily. The total duration of blinded therapy is 100 weeks
15848238|NCT04056897|Biological|BCD-132, 500 mg|IV infusion every 24 weeks in combination with placebo tablet daily. The total duration of blinded therapy is 100 weeks (a total of 5 cycles of therapy BCD-132 in combination with a daily placebo)
15848239|NCT04056884|Behavioral|SIBS intervention|SIBS is a manual-based group intervention for siblings and parents of children with chronic illness
15848240|NCT04056871|Diagnostic Test|Frailty Screening Tools|This is an observational and prospective study of patients who are going for elective surgery, thus no intervention will be given.
15848241|NCT04056845|Device|Valgus knee brace (Medex K39-OA Corrector)|Valgus knee brace given to patients as part of the conservative management for knee osteoarthritis.
15848242|NCT04056845|Other|Physiotherapy and oral analgesic (diclofenac and panadol)|Physiotherapy and oral analgesic (diclofenac and panadol)
15848243|NCT04056832|Procedure|Single Strip Pericardium|The anterior pericardium is taken in accordance with the measurements made using an aortic annulus sizer or Ismail sizer. The diameter of the annulus valve is converted to circumference of the aortic valve according as a measure of the length of the pericardium. Measurement of aortic commissure height is done by measuring the distance between the lowest point of the valve attachment to the highest point on the commissure as a measure of pericardium width. The pericardium is immersed in 0.6% glutaraldehyde solution for 10 minutes, then rinsed and soaked with saline solution 3 times for 6 minutes each. After the pericardium becomes firm it is cut to be a single strip according to the length and width in the previous measurement. It is then sutured to the aortic valve annulus.
15848244|NCT04056832|Procedure|Mechanical Prosthetic Valve|Median incision is performed at the surgical site. Sternal retractor is placed at the sternum after median sternotomy being performed. Aortic valve is measured using aortic annulus sizer. Pledgeted suture is performed for the mattress. Sutures are performed to attach the mechanical prosthetic to the aortic annulus.
15848245|NCT04056819|Biological|Allogeneic umbilical cord mesenchymal stem cells|UMSC01 cells will be one single IC infusion followed by one single IV infusion with 12 months of follow up after treatment.
15848246|NCT04056806|Drug|Terlipressin 1Mg Powder for Conventional Release Solution for Injection Vial|efficacy comparison between 2 days and 5 days
15848247|NCT04056793|Other|Optimized birthing position|The parturients will be asked to adopt a supine position with a hyperflexion of the thighs and a flat back, and to maintain the position for a duration of twenty minutes.
15848248|NCT04056780|Other|Sample collection study|Sample collection and collection of laboratory values
15848249|NCT04056754|Drug|Abiraterone Acetate|Subjects administered 4 tablets abiraterone acetate twice daily in 28-day cycle.
15848250|NCT04056754|Drug|Placebo|Subjects administered 4 tablets abiraterone acetate blank analog tablet twice daily in 28-day cycle.
15848251|NCT04056754|Drug|Prednisone|Subjects administered 5mg prednisone twice daily in 28-day cycle.
15848252|NCT04056741|Combination Product|surfactant airway device|Infants who meet eligibility criteria and have a signed consent form by their parent or guardian will be enrolled in the study. Once enrolled, the surfactant airway device placement and surfactant administration will occur as detailed in the protocol. The infant will be monitored. If the infant meets instillation failure criteria, the procedure will be repeated shortly after the initial procedure. A maximum of two (2) doses will be given during the initial procedure. If the infant meets re-dosing criteria, (s)he may receive up to two (2) additional doses through the surfactant airway device (initial procedure with 1-2 doses and up to two additional doses). If at any time the infant reaches treatment failure criteria, the infant would be intubated and receive a site-specific surfactant through an endotracheal tube. Study outcome data will be followed until discharge from the NICU.
15848253|NCT04056728|Biological|Eupenta Inj.|fully liquid pentavalent vaccine, Adsorbed Diphtheria-Tetanus-whole-cell Pertussis-Hepatitis B (rDNA [recombinant-deoxyribonucleic acid])-Haemophilus influenzae type b conjugate vaccine single dose 0.5 mL/vial The vaccine is given at 6, 10 and 14 weeks of age in infants.
15848254|NCT04056715|Device|Zio XT|ambulatory cardiac monitoring device
15848255|NCT04056702|Drug|Elexacaftor-tezacaftor-ivacaftor exposure|Once a clinical decision has been made to prescribed a patient triple combination therapy, people with CF are eligible to participate in this study.
15848256|NCT04056689|Drug|DNL151|Oral repeating dose
15848257|NCT04056689|Drug|Placebo|Oral repeating dose
15848425|NCT04055246|Dietary Supplement|Inulin|9 grams of food grade inulin added to custom made fiber bars.
15848258|NCT04056676|Procedure|Thoracic paravertebral block under ultrasound guidance|Ultrasound-guided thoracic paravertebral blocks in T2, T4 level
15848259|NCT04056676|Procedure|Intraoperative modified PEC block|Pectoral nerve block by surgeon under direct vision after total mastectomy
15848260|NCT04056676|Procedure|GA with ETT|General anesthesia with endotracheal intubation
15848261|NCT04056663|Behavioral|Health-Circuit mobile application|Health-Circuit as a collaborative tool between professionals and patient and professionals
15848262|NCT04056650|Drug|L-theanine|up to 250 mg
15848263|NCT04056650|Dietary Supplement|Caffeine supplement|50-400mg
15848264|NCT04056650|Device|N1 app|N1 App on mobile device
15848265|NCT04056637|Other|Choice of follow-up option|Participant will be given the opportunity to choose from 3 follow-up options.
15848266|NCT04056637|Device|Multi-level pregnancy test|The Multi-level pregnancy test (MLPT) strategy involves the use of the MLPT to estimate a pregnant person's baseline hCG range prior to beginning their abortion (i.e. prior to mifepristone administration). A follow-up test is then administered one week later to again estimate the woman's hCG range. A decline in hCG range reliably signifies absence of an ongoing pregnancy. Among clients ≤63 days' LMP at initiation of treatment, this strategy has shown to be highly effective: 100% of clients (n=1487/1487) with a decline in hCG range did not have an ongoing pregnancy and 100% of clients (n=21/21) with an ongoing pregnancy showed steady or increase in hCG range on their follow-up MLPT.
15848267|NCT04056624|Dietary Supplement|High carotenoid juice|Juice with high carotenoids
15848268|NCT04056624|Dietary Supplement|Placebo control - Apple juice|Juice with negligible carotenoids
15848272|NCT04056598|Diagnostic Test|Study of humoral immunity|Analysis: Surface antigen ELISA, recognition of living P. acnes bacteria via FACS, 16SRNA study of microbiome, SLST typing of P. acnes bacteria
15848273|NCT04056585|Procedure|Ultrasound guided axillary plexus block|Ultrasound guided axillary plexus block with 1.5% mepivacaine 30 ml
15848274|NCT04056585|Procedure|Intermittent pneumatic compression maneuver|Following ultrasound guided axillary plexus block, the pneumatic compression maneuver of upper arm is composed of 6 repeated inflation-deflation periods; inflation with a pressure of 200 mmHg for 30 seconds and deflation for 10 seconds each.
15848275|NCT04056572|Drug|TQ-B3139|TQ-B3139 is competitive multi-target protein kinase inhibitor of Met/ALK/ROS.
15848276|NCT04056559|Device|Adaptable mouthguards|Validate a prototype of Adaptable Intra-Oral Protections patented by Bordeaux University and Bordeaux University Hospital according to 3 levels (ventilation, comfort, cervical muscle activity).
15848277|NCT04056533|Biological|CMV CTLs|The donor derived cytomegalovirus specific T lymphocytes (CMV-CTL) will be transfused to the patients. The patients will receive CMV-CTL cells when their donors are sero-positive for CMV-DNA 21 days after transplant. The CMV-DNA levels will be monitored weekly for at least 100 days after the HAPLO. If after the initial dose of CMV-CTL cells the patient develops a viral infection, then they may be eligible to receive a CMV specific antiviral drug.
15848279|NCT04056507|Procedure|Immunolabeling|Immunolabeling of abnormalities observed by the cell study in flow cytometry.
15848280|NCT04056481|Drug|Givosiran|givosiran (ALN-AS1) administered as a subcutaneous (SC) injection
15848281|NCT04056468|Drug|Mobocertinib|Mobocertinib capsule.
15848282|NCT04056455|Drug|Mobocertinib|Mobocertinib capsule.
15848283|NCT04056442|Drug|Cannabidiol , synthetic form|Cannabidiol ( synthetic form)
15848284|NCT04056442|Drug|Placebo|Olive Oil Solution, 5%
15848285|NCT04056429|Combination Product|BHA|BHA active ingredients include beta-tricalcium phosphate and a blood-derived component. It is applied directly to the bone fracture and nearby viable bone at the time of wound closure.
15848286|NCT04056416|Device|MedBIKE|A MedBIKE will be installed into a participants home and connected to clinicians via telehealth for monitoring during exercise sessions. Sessions will be based on standardized guidelines for aerobic exercise. Heart rate, ECG, oxygen saturation and rating of perceived exertion will be monitored throughout the session.
15848287|NCT04056390|Procedure|Catheter ablation using irrigated radiofrequency current ablation or cryothermal energy|Substrate ablation in terms of voltage abatement versus electrical left atrial appendage isolation.
15848288|NCT04056364|Biological|sputum cytology|Sputum cytology refers to the examination of sputum (mucus) under a microscope to look for abnormal or cancerous cells. Sputum, or phlegm, is the fluid that is secreted by cells in the lower respiratory tract such as the bronchi and the trachea. It differs from saliva, in that it contains cells that line the respiratory passages.
15848289|NCT04056351|Diagnostic Test|Post-Operative (OP) Computer Tomography (CT)|Post-OP CT of the treated shoulder
15848290|NCT04056351|Other|Questionnaires on patient activity and comorbidities|"Shoulder activity scale (Marx)
~Parker Mobility Scale
~Barthel index
~Charlson Comorbidity Score"
15848291|NCT04056351|Other|Grip strength measurement|Grip strength will be measured using a CE marked hydraulic hand dynamometer device.
15848292|NCT04056351|Other|Non-invasive shoulder activity tracking usinig wearable sensors|Post-OP activity will be assessed via wearable CE-marked accelerometer sensors.
15848293|NCT04056338|Other|No intervention|No intervention.
15848294|NCT04056325|Drug|Moxidectin|Monotherapy, oral administration, single dose, fixed dose
15848295|NCT04056325|Drug|Ivermectin|Monotherapy, oral administration, single dose, weight dependent
15848296|NCT04056325|Drug|Placebo oral tablet|Monotherapy, oral administration, single dose, matching number of tablets
15848297|NCT04056312|Behavioral|Group Memory retraining exercises|Experimental group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group.
15848298|NCT04056312|Behavioral|Placebo controlled group memory exercise training|Placebo group will be receiving memory retraining exercises via lap top twice a week for 5 weeks. Four people in a group.
15848299|NCT04056299|Biological|AR201 Powder|AR201 powder provided in capsules (Hen Egg allergen formulation)
15848300|NCT04056299|Biological|Placebo powder|Placebo powder provided in capsules
15848301|NCT04056286|Dietary Supplement|Whey|45 g whey protein + 20 g maltodextrin
15848302|NCT04056286|Dietary Supplement|3-OHB/whey|50 g 3-OHB + 45 g whey protein + 20 g maltodextrin
15848305|NCT04056260|Procedure|ICG-NIR guided surgery|ICG 0.5mg/ml x 0.5ml x 4 sites injection through intra-operative endoscopy
15848307|NCT04056234|Procedure|Joint puncture|Patient requiring joint puncture for diagnostic or therapeutic reasons.
15848308|NCT04056221|Other|Acupuncture|Acupuncture stimulation was done manually, using single-use acupuncture needles that will be inserted on the selected acupoints (R6, E6, E2, Ig4, VC24, TA23, B2) once a week,for 8 weeks, 20 minutes sessions with 12 weeks of follow up.
15848309|NCT04056221|Other|Sham acupuncture|The sham acupuncture consists of needles that achieves no skin penetration and are holden on the points by an adhesive pad.
15848310|NCT04056208|Drug|Pistachio|Unsalted pistachios
15848311|NCT04056208|Other|Usual care|Advice and resources will be provided
15848312|NCT04056195|Drug|SKI-O-703|The SKI-O-703 capsules will contain 100 mg of drug substance.
15848313|NCT04056195|Drug|Placebo oral tablet|Placebo capsules are filled with microcrystalline cellulose.
15848314|NCT04056182|Drug|Lofexidine 0.18 MG|Lofexidine prescribed as three 0.18mg tablets taken orally 4 times daily at 4-to 6-hour intervals for 2-10 days for the management of opioid withdrawal symptoms prior to receiving Vivitrol.
15848315|NCT04056169|Drug|high-dose rosuvastatin|rosuvastatin 20 mg once a day for 6 months
15848316|NCT04056169|Drug|low-dose rosuvastatin plus ezetimibe|ezetimibe/rosuvastatin 10/5 mg once a day for 6 months
15848317|NCT04056156|Behavioral|HIV-screening advice|To increase GP's HIV-testing behavior a targeted HIV-testing advice is spread to participants through an electronic mail
15848318|NCT04056156|Behavioral|HIV-testing advice plus group-level training|To increase specific HIV-testing behavior among GPs a targeted HIV-testing advice is spread to participants through an electronic mail and an additional face-to-face group-level training is provided.
15848319|NCT04056143|Diagnostic Test|Pharmacogenomics|Subjects enrolled in this study are providing blood samples for completing a set of laboratory testing and pharmacogenomic analyses. They are requested to comply a Pharmacist interview and complete of assisted questionnaires.
15848320|NCT04056130|Drug|KBL697|"Part A: 1 day 460mg/day of KBL697 or placebo
~Route of Administration: Oral"
15848321|NCT04056130|Drug|KBL697|"Part A: 1 day 4,600mg/day of KBL697
~Route of Administration: Oral"
15848322|NCT04056130|Drug|KBL697|"Part B: 14 days
~Cohort MAD1:
~460mg/day of KBL697
~Route of Administration: Oral"
15848323|NCT04056130|Drug|KBL697|"Part B: 14 days
~Cohort MAD2:
~4,600mg/day of KBL697
~Route of Administration: Oral"
15848324|NCT04056117|Biological|Shigella 4V|Non-adjuvanted and adjuvanted Shigella 4V administrated at 4 different doses: very low, low, medium and high.
15848325|NCT04056117|Biological|MenACWY|Control vaccine administrated to adults and infants
15848326|NCT04056117|Biological|Rabies|Control vaccine administrated to children
15848327|NCT04056117|Biological|Diphtheria, Tetanus and Pertussis (DTaP)|Control vaccine administrated to infants
15848328|NCT04056117|Biological|Placebo|Control administrated to adults
15848329|NCT04056104|Diagnostic Test|SpO2 and PIx Measurement|Right upper and any lower extremity oxygen saturation (SpO2) and perfusion index (PIx) will be measured
15848330|NCT04056091|Procedure|Back rub stimulation|Immediately after birth, all infants with an expected birthweight >1500 g who have been dried and remain apneic (not crying) will receive physical stimulation (back rubs). Stimulation can be repeated at maximum two or three times for about 3-5 seconds.
15848331|NCT04056091|Procedure|Foot flicks stimulation|Immediately after birth, all infants with an expected birthweight >1500 g who have been dried and remain apneic (not crying) will receive physical stimulation (foot flicks). Stimulation can be repeated at maximum two or three times for about 3-5 seconds.
15848332|NCT04056065|Drug|Normal Saline|In addition to standard of care normal saline to be used as vehicle in the phase-II study to assess efficacy of PMZ-2010 as a resuscitative agent for hypovolemic shock
15848333|NCT04056065|Drug|Centhaquine|In addition to standard of care PMZ-2010 to be used as an experimental drug in the phase-II study to assess its efficacy as a resuscitative agent for hypovolemic shock
15848334|NCT04056052|Behavioral|Mind the Gap: Home Activity Only|The primary focus of the home activity program was based on collaborative parent-child cooking activities which the families undertook themselves at home. There were two key tasks: the first was to add one extra vegetable to the evening meal each day, the second was to select, prepare and cook one recipe from the cook book each week.
15848335|NCT04056052|Behavioral|Mind the Gap: Home Activity + cooking Workshop|The main purpose of these workshops was to provide hands-on successful food preparation and cooking experiences for the families and several opportunities to taste new vegetable-based recipes as well as promoting knowledge of cost and healthy eating. Children and their parents were then encouraged to take whatever was learned and apply it at home.
15848336|NCT04056039|Drug|Atorvastatin|Efficacy of atorvastatin 40 mg orally every 24 hours for four weeks vs colchicine with an initial dose of 0.25 mg every 8 hours, with titration in the first 3 days according to tolerance up to a maximum dose of 0.5 mg every 8 hours for four weeks in decrease of troponin I of high sensitivity
15848426|NCT04055246|Dietary Supplement|Placebo (maltodextrin)|9 grams of food grade maltodextrin - replaces inulin in fiber bars.
15848337|NCT04056039|Drug|Colchicine|Efficacy of atorvastatin 40 mg orally every 24 hours for four weeks vs colchicine with an initial dose of 0.25 mg every 8 hours, with titration in the first 3 days according to tolerance up to a maximum dose of 0.5 mg every 8 hours for four weeks in decrease of troponin I of high sensitivity
15848338|NCT04056026|Biological|Fecal Microbiota Transplant|Fecal material from a healthy family donor will be transplanted into the patient via colonoscopy
15848339|NCT04056013|Device|Vicryl Rapide absorbable suture|"In general, most laceration repair has been done with sutures on the surface of the skin that do not break down and fall off on their own, so after enough days have passed for the laceration to heal properly, the patient needs to return to the ED to have the sutures removed by cutting them off. These sutures are called nonabsorbable. Some newer sutures have been designed to slowly dissolve on their own and fall out over several days. These are called absorbable sutures. You do not normally need to return to the ED for removal as these should slowly dissolve and fall out on their own."
15848340|NCT04056000|Dietary Supplement|Caffeine|200 mg of caffeine, 60 minutes before exercise
15848341|NCT04056000|Dietary Supplement|High-carbohdyrate breakfast|Ingestion of a high-carbohydrate breakfast 60 minutes before exercise
15848342|NCT04056000|Behavioral|60-minutes of steady state exercise|See intervention name
15848343|NCT04055987|Behavioral|Visual biofeedback, auditory feedback and models|The EPG software program allows the speech clinician to model and comment upon the visual patterns during tongue/palate contact and to replay the participant's production for additional correction or reinforcement productions. Auditory feedback will be used to facilitate participant's perception of differences in production.
15848344|NCT04055974|Behavioral|Be a Mom|The Be a Mom program is a web-based self-guided cognitive-behavioral intervention targeting postpartum women. It consists of 5 weekly modules, each targeting a specific thematic content, and providing women with both information and specific therapeutic strategies (with a strong focus on cognitive-behavioral techniques) to address each thematic content. Modules are sequential.
15848345|NCT04055961|Device|Atrial Fibrillation Ablation|A procedure used to treat an irregular heart rhythm (arrhythmia)
15848346|NCT04055948|Behavioral|One-on-one teaching sessions|One-on-one teaching sessions with the caregiver during radiation treatments. (note - intervention sessions 2 & 3 delivered by phone during COVID-19)
15848347|NCT04055948|Behavioral|Telephone booster contact|Telephone booster contact 2 weeks post-treatment.
15848348|NCT04055935|Procedure|elevation of full thickness mucoperiosteal flap|A free gingival sulcular incision was done from the distal surface of maxillary second premolar to the mesial side of the maxillary canine. A releasing oblique incision was done including the interdental papilla between maxillary canine and lateral incisor extending to the mucogingival junction just beyond the attached mucosa. The flap reflection extended beyond the canine root apex. A FTMPF reflection was done with mucoperiosteal elevator. Free sulcus incision was done to allow elevation of palatal mucosa by tunneling technique on the palatal gingiva of maxillary canine.
15848349|NCT04055935|Device|low level laser therapy|LLLT was done using a diode soft laser (Epic X, BioLase, USA). It is a semiconductor diode soft laser. Active medium is In-Ga-As with 940nm wave length. LLLT protocol was using active laser tip (bleaching tip)
15848350|NCT04055909|Drug|nangibotide low dose|nangibotide 0.3 mg/kg/h
15848351|NCT04055909|Drug|nangibotide high dose|nangibotide 1.0 mg/kg/h
15848352|NCT04055909|Drug|placebo|matching placebo
15848353|NCT04055896|Other|Medication Reduction|Systematic approach to reduction in polypharmacy
15848354|NCT04055883|Drug|DA-1229|All participants are administered one tablet per day for 96 weeks
15848355|NCT04055870|Procedure|EUS-guided liver biopsy at MDMC|Endoscopic ultrasound (EUS) guided liver biopsy sampling is emerging as an alternative to the aforementioned approaches that offers several advantages, including decreased sampling variability and procedure-related complications.
15848356|NCT04055844|Drug|Decitabine|10 days of decitabine 20 mg/m2 IV daily; or, alternatively, per institution, physician, or patient preference on a 5-2-5 schedule with no weekend infusion. If a CR is achieved after 2 cycles using the 10-day schedule, subsequent cycles will change to a 5-day schedule.
15848357|NCT04055844|Drug|Ruxolitinib|Starting with day 1 of cycle 1 and continuing for up to 6 months after the end of the last cycle, patients will receive ruxolitinib 5 mg twice daily orally. Dose may be increased to 10 mg twice daily in cycles 2 through 4 if platelets improve to >100 x 10^9/L.
15848358|NCT04055844|Drug|Donor Lymphocyte Infusion (DLI)|DLI from the original donor will be infused within 10 days after the last dose of decitabine in each cycle.
15848359|NCT04055818|Drug|Nicotinamide|Oral nicotinamide (Vitamin B3) alone compared to THU Decitabine combination
15848360|NCT04055805|Behavioral|Observational Analysis|Studying the current state of the clinical approaches to bone diseases in breast cancer patients treated with adjuvant and/or hormone therapy
15848361|NCT04055792|Drug|Sintilimab|Sintilimab 200mg intravenously on day 1 of each 3-week cycle
15848362|NCT04055792|Drug|Anlotinib|Anlotinib 12mg per os on day 1-14 of each 3-week cycle
15848363|NCT04055779|Other|estimation method for arterial occlusion pressure|The patients will receive induced hypotensive anaesthesia and the tourniquet pressure will be based on the AOP.the tourniquet pressure will be determined based on the AOP which will be determined by the estimation formula (AOP=[SBP+10]/KTP) . The calculation is based on using initial SBP and tissue padding coefficient values , according to limb circumferences of the patient.After calculation of AOP, tourniquet pressures will be determined by adding a safety margin of 20 mmHg to AOP values(tourniquet pressure=AOP+20 mmHg).
15848364|NCT04055779|Other|the limb occlusion pressure|: using the ultrasound Doppler technique and the tourniquet will be inflated until the arterial pulsations disappear at the side of the operation. This pressure will be recorded as LOP.using the ultrasound Doppler technique and the tourniquet will be inflated until the arterial pulsations disappear at the side of the operation. This pressure will be recorded as LOP .the tourniquet cuff will be inflated to the pressure according to theguidelines of the Association of Perioperative Registered Nurses(AORN) which recommends that a safety margin of 40 mmHg should be added for AOP below 130 mmHg, 60 mmHg for AOP between 131 mmHg and 190 mmHg, and 80 mmHg for AOP above 190 mmHg for adult patients
15848365|NCT04055766|Device|DeepDoc AI-based Decision Support System|Patients are diagnosed by the DeepDoc within 24 hours of admission.
15848366|NCT04055753|Drug|Doxil|Doxil 50 mg/m2, as per institutional standard
15848367|NCT04055753|Drug|Doxorubicin|Doxorubicin 75 mg/m2, IV over 5-15 min OR Continuous infusion over 48-72 hours
15848368|NCT04055740|Device|IVUS Imaging|IVUS or radial-ICE (intracardiac echocardiography) is a visualization tool used in many cardiac procedures including electrophysiology procedures (catheter ablation). Its utility in identifying ILA will be assessed in this study.
15848369|NCT04055714|Device|Balloon dilation of the Eustachian tubes|Use the Aera Balloon through the nose to dilate the Eustachian tubes
15848370|NCT04055701|Other|assesment of thymus volume|assesment of thymus volume
15848371|NCT04055688|Device|Orbeye surgical videomicroscope|The ORBEYE surgical microscope is an FDA-cleared apparatus designed to facilitate operating procedures that involve fine nerves, blood vessels, and other small anatomic features by providing an enlarged stereoscopic visual field of the surgical site. The 4K 3D digital images of the ORBEYE microscope provide high-resolution stereoscopic images of the fine structures of tissue and blood vessels. As the surgical procedures are displayed on a large 55-inch monitor, the device is expected to reduce fatigue of the operator by eliminating the need for extensive viewing via microscope eyepieces for an extended period of time. The technology adopted in the ORBEYE was developed by Sony Olympus Medical Solutions, and its product design was handled by Olympus Medical Systems Corp. The ORBEYE is marketed by the Olympus Corporation.
15848372|NCT04055688|Drug|5-Aminolevulinic Acid|5- aminolevulinic acid (5-ALA) is a European Medicines Agency- and Food and Drug Administration- (FDA-) approved drug that is administered to patients 2 to 4 hours before surgery and converted preferentially by tumor cells to protoporphyrrin IX (PPIX). PPIX fluoresces red when exposed to blue light. Use of 5-ALA has previously been shown to permit surgeons to obtain a more complete tumor resection, and its use has also been associated with an increased rate of progression-free survival.(3) There are currently 2 surgical microscope systems available on the market that are equipped with a 5-ALA visualization system. These visualization systems are currently classified by the FDA as Class I-exempt accessories to Class I-cleared surgical microscopes.
15848373|NCT04055675|Diagnostic Test|Urine dipstick test|A sample of urine will be tested using a Mission Urinalysis Reagent Strip.
15848374|NCT04055649|Drug|Akt/ERK Inhibitor ONC201|Given orally (PO)
15848375|NCT04055649|Drug|Paclitaxel|Given IV
15848376|NCT04055649|Other|Questionnaire Administration|Ancillary studies
15848380|NCT04055623|Biological|Monthly autologous Treg cells infusions + 3 times per week Interleukin-2 injections|For the first 6-months of the study: T-regulatory cells taken from a patient, increased in number in a lab, and returned through monthly intravenous (IV) infusions back to same patient + 3 times per week subcutaneous Interleukin-2 injections
15848381|NCT04055623|Other|Monthly placebo infusions + 3 times per week placebo injections|For first 6-months of study: monthly placebo infusions + 3 times per week subcutaneous placebo injections
15848382|NCT04055623|Biological|Monthly autologous Treg cells infusions + 3 times per week Interleukin-2 injections|For the second 6-months of the study: all participants will receive T-regulatory cells taken from the patient, that have been increased in number in a lab, and returned through monthly intravenous (IV) infusions back to same patient (Treg cell owner) + 3 times per week subcutaneous Interleukin-2 injections.
15848383|NCT04055610|Device|Gait training using H-MEX exoskeleton|Participants will train 3 times a week for 10 weeks using H-MEX powered exoskeleton.
15848384|NCT04055597|Other|Robot and tDCS on-line|Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot for 5 times a week for 4 weeks
15848385|NCT04055597|Other|Robot and sham tDCS|Combined sham tDCS and upper extremity rehabilitation robot for 5 times a week for 4 weeks
15848386|NCT04055584|Diagnostic Test|Sputum|DNA extraction and perform a diversity of molecular diagnostic tests
15848387|NCT04055545|Other|HIIT|"5 min. warm up
~10 × 60 seconds burst
~60 seconds recovery after each burst
~Burst phase: HRR >90%
~Recovery phase: HRR btw. 30-39%
~5 min. cool down"
15848388|NCT04055545|Other|MICT|"5 min. warm up
~20 min. continuous cycling: HRR btw. 40% - 59%
~5 min. cool down"
15848389|NCT04055532|Other|Neuraceq|Neuraceq is a radioactive isotope used for Amyloid-beta-PET/CT scans.
15848390|NCT04055519|Device|Lehfilcon A contact lenses|Investigational silicone hydrogel contact lenses
15848391|NCT04055519|Device|Comfilcon A contact lenses|Commercially available silicone hydrogel contact lenses
15848392|NCT04055519|Device|Multi-purpose disinfection solution|Solution for cleaning, disinfecting, and reconditioning silicone hydrogel contact lenses
15848393|NCT04055506|Drug|BMS-986165|Dose 1
15848394|NCT04055506|Drug|Ritonavir|100 mg
15848395|NCT04055493|Drug|Ribociclib 200Mg Oral Tablet|3 x 200 MG per os
15848396|NCT04055480|Device|Closed-loop using standard rapid-acting insulin|Closed-loop using standard rapid-acting insulin
15848397|NCT04055480|Device|Closed-loop using faster insulin aspart|Closed-loop using faster insulin aspart
15848398|NCT04055467|Drug|[F18]-ASEM (3-(1,4-diazabicyclo[3.2.2]nonan-4-yl)-6-[18F]fluorodibenzo[b,d]thiophene 5,5-dioxide)|Brain imaging of alpha-7 nicotinic acetylcholine receptors
15848399|NCT04055467|Behavioral|Contingency Management|Incentive payments contingent upon provision of samples that meet criterion levels of exhaled carbon oxide and urinary cotinine at study visits
15848400|NCT04055454|Biological|MV-LASV|The MV-LASV vaccine candidate is a recombinant live attenuated viral vectored vaccine, based on the backbone of the measles Schwarz virus strain for prophylaxis of Lassa infection and will be administered in two different dose levels by intra muscular (i.m.) injection.
15848401|NCT04055454|Other|Placebo|A sterile physiological saline solution will be used as placebo to ensure blinding of the treatment with low dose MV-LASV and placebo within treatment group A. Additionally, the Placebo will be used as a control arm to enable comparison of treatment reactions within treatment groups B and C.
15848402|NCT04055428|Drug|Sacubitril, Valsartan 97-103 mg Oral Tablet|The subject will be randomized, in a double-blind manner to sacubitril/valsartan 97/103 mg twice daily for a period of 12 weeks.
15848403|NCT04055428|Drug|Valsartan 160 mg|The subject will be randomized, in a double-blind manner to valsartan 160 mg twice daily for a period of 12 weeks.
15848514|NCT04054557|Other|Telemedicine|Participate in virtual visits with oncologist
15848404|NCT04055428|Other|Intravenous Glucose Tolerance Test|An assessment of the insulin sensitivity will be done using the IVGTT, at baseline and after 12 weeks of pharmacological interventions.
15848405|NCT04055428|Dietary Supplement|Standardized Meals|Participants will consume the standardized study mixed meal for the assessment of postprandial GLP-1 response to the meal.
15848406|NCT04055428|Other|Exercise capacity VO2 maximum determination|Each participant's maximal oxygen capacity will be determined using modified Bruce treadmill protocol.
15848407|NCT04055415|Biological|adipose derived mesenchymal stem cells|The MSCs of 1×10*6/kg will be given in Central venous catheterization for injection at a total 100 ml (2) the experimental group was treated with conventional drug and adipose mesenchymal stem cell injection, and adipose MSCs were treated with central venous catheterization. The injection cycle was once every week of two times.Injection dose: 1×106 /kg.
15848408|NCT04055415|Drug|Conventional drug therapy（expectorant，bronchodilator）|Conventional drug therapy（expectorant，bronchodilator）
15848409|NCT04055402|Other|Ecological momentary assessments|The staff will help the participants in the EMA group to install and set up the EMA App. The briefing will also emphasise the role of EMA participants that they should perform their normal activities as usual instead of finding out the alcohol advertisements and PADC intentionally. Within 2 weeks after completing the baseline survey, participants in EMA group will complete 5 EMAs prompted regularly every day for 14 consecutive days. The participants will then be contacted for a follow-up survey 2 weeks after the completion of EMA.
15848410|NCT04055402|Other|Control|Completion of a baseline questionnaire and a 1-month follow-up survey.
15848411|NCT04055389|Drug|Antithrombin III|"Patients with reversal of flow or sluggish flow in the main portal vein (<15 cm/s by Doppler ultrasound exam) will be enrolled and randomized to either weekly infusions of AT-III (half-life ~4 days) at a weight-based dosage according to the following formula:
~[Desired level of AT (100%) - Subject level of AT (%)] * subject weight (kg) 1.4
~or placebo for 24 weeks of therapy."
15848412|NCT04055389|Other|Placebo|No study drug
15848413|NCT04055376|Device|GENUS device (Active Settings)|"Participants in the experimental group will use the GENUS device configured to active settings for 60 minutes daily over 6 or 9 months. After 6 or 9 months, each participant will be given an option to continue the daily usage of the GENUS device configured to active settings for additional 6 or 9 months.
~Note: Due to the COVID-19 pandemic, participants who have not yet reached the 6-month mark will have their 6 month visit postponed to 9 months."
15848414|NCT04055376|Device|GENUS device (Sham Settings)|"Participants in the control group will use the GENUS device configured to sham settings for 60 minutes daily over 6 or 9 months. After 6 or 9 months, each participant will be given an option to continue the daily usage of the GENUS device configured to active settings for additional 6 or 9 months.
~Note: Due to the COVID-19 pandemic, participants who have not yet reached the 6-month mark will have their 6 month visit postponed to 9 months."
15848415|NCT04055363|Other|HMO-supplemented infant formula|Starter Infant Formula supplemented with 1.5g/L of Human Milk Oligosaccharides
15848416|NCT04055337|Procedure|Flap sliding|"All subjects underwent the flap sliding technique, which was performed at the Alforsan Eye Centre in Assiut, Egypt. Prior to surgery, all subjects underwent corneal imaging with anterior segment optical coherence tomography to confirm the presence of striae. All surgical procedures were performed by the same surgeon 1 or 2 days following LASIK.
~Subjects were administered a topical anesthetic. Striae location and orientation were then determined after drying the corneal surface with a cellulose sponge. The sponge was used to push the LASIK flap over the stromal bed in a direction that was perpendicular to the striae. The flap was pushed from the proximal side of the striae toward the flap edge. The ultimate goal was to move striae and put the flap into its proper place. Following surgery, OCT imaging was repeated."
15848417|NCT04055311|Behavioral|CRIS - Cancer Resource Information Support|Intervention support is patient initiated and accessed as needed
15848418|NCT04055311|Behavioral|Usual Care Enhanced|Usual care is enhanced with the addition of the NCI Facing Forward brochure
15848419|NCT04055298|Device|SMASS-Triage|SMASS-Triage is a web-based symptom checker developed by In4medicine Ltd. SMASS-Triage is based on a computerized transparent neural network, which was trained with the evidence of more than 1200 studies and the expertise of various panels of specialists in the field of preclinical medical triage. SMASS-Triage provides digitalized questionnaires of 87 frequent reasons of encounters (e.g. fever, cough, abdominal pain) and their associated red flags. The triage-result of SMASS-Triage encompasses the appropriate time-to-treat (T2T) and the adequate point-of-care (PoC).
15848420|NCT04055285|Procedure|Sympathetic Renal Denervation|Catheter-based sympathetic renal denervation (RDN) using radiofrequency, ultrasound, or perivascular injection of neurotoxic agents such as alcohol has been introduced as a minimally invasive alternative treatment option for patients with resistant hypertension. RDN consists of endovascular catalysis of the kidney sympathetic nerves running in the wall of the renal arteries.
15848421|NCT04055285|Device|Implantable Loop Recorder|Implantable Loop Recorders (ILRs) are small, subcutaneously implanted devices that are able to detect and store atrial fibrillation episodes lasting longer than 2 minutes with high sensitivity (96.1-100%) and good specificity (67-85.4%) for a period of up to three years.
15848422|NCT04055272|Behavioral|Mobile text messaging intervention|Participants in the intervention arm will receive text messages to their mobile phones designed to communicate the risks of indoor tanning and motivate cessation. The intervention exposure lasts for 4 weeks with messages sent 2 days each week. It is an interactive intervention that engages participants by asking them to respond to prompts, and sending indoor tanning message content in return on message days.
15848423|NCT04055259|Behavioral|mobile Health and Wellness Coaching|Participants in the mobile health and wellness coaching (mHWC) group received text-based mHWC messages and did not return to the clinic until the end of the 6 month intervention. Messages were sent at least weekly and focused on facilitating the adoption and maintenance of health behaviors related to diet, physical activity and sleep to promote weight loss. Participants could respond via text at any time. The Nudge platform was used for all messaging.
15848424|NCT04055259|Behavioral|Usual Care|Participants in the usual care (UC) group met in-person once a month with either a pharmacist or dietician for the duration of the 6-month intervention. The focus of these sessions was on facilitating the adoption and maintenance of health behaviors related to diet, physical activity and sleep to promote weight loss. These participants were set up on the Nudge app, but they did not use the mHWC (texting) feature.
15848427|NCT04055233|Drug|Polihexanide; Serasept|"Experimental arm: irrigation of subcutaneous tissue after fascia closure with polihexanide (ten minutes).
~A single dose of perioperative antibiotics (cefuroxim alone or cefuroxim and metrodidazole in bowel surgeries) was given 30 minutes before skin incision.
~Hair removal was done with electronic clippers and preoperative skin antisepsis was performed with propanol and povidone-iodine.
~Before closure of fascia, instruments and gloves were changed. No subcutaneous suture was used. Skin was closed either with skin staples, continuous intracutaneous suture or interrupted suture.
~All surgeries were done according to the Standard Operating Procedures of the Department for General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin."
15848428|NCT04055233|Drug|NaCl; saline|"Control arm: irrigation of subcutaneous tissue after fascia closure with NaCl (one minute) A single dose of perioperative antibiotics (cefuroxim alone or cefuroxim and metrodidazole in bowel surgeries) was given 30 minutes before skin incision.
~Hair removal was done with electronic clippers and preoperative skin antisepsis was performed with propanol and povidone-iodine.
~All surgeries were done according to the Standard Operating Procedures of the Department for General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin.
~Before closure of fascia, instruments and gloves were changed. No subcutaneous suture was used. Skin was closed either with skin staples, continuous intracutaneous suture or interrupted suture.
~All surgeries were done according to the Standard Operating Procedures of the Department for General, Visceral and Vascular Surgery, Charité Campus Benjamin Franklin."
15848429|NCT04055220|Drug|Treatment by Regorafenib|Treatment for 13 cycles (12 months) maximum. During each cycle, patient will take 3 tablets, once a day, corresponding to a total of 120 mg Regorafenib, during 21 days, followed by 7 days without treatment.
15848430|NCT04055220|Drug|Treatment by Placebo|Treatment for 13 cycles (12 months) maximum. During each cycle, patient will take 3 placebo tablets, once a day, during 21 days, followed by 7 days without placebo treatment.
15848431|NCT04055207|Other|VVC|Telehealth treatment is delivered via VA-approved technology to a patient's computer or mobile device.
15848432|NCT04055194|Drug|Tranexamic acid tablets|Pregnant women with symptomatic placenta previa with previous bleeding attacks will receive tranexamic acid tablets (500mg four times daily) till delivery.
15848433|NCT04055194|Drug|Placebo oral tablet|Pregnant women with symptomatic placenta previa with previous bleeding attacks will receive placebo tablets four times daily till delivery.
15848434|NCT04055181|Device|rTMS in schizophrenia Controls|"all procedures were identical to rTMS in schizophrenia patients group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated."
15848435|NCT04055181|Device|rTMS in schizophrenia patients|10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 27-s intervals with 20s intertrain interval. 20 minutes were administered each day (Monday-Friday) for 4 consecutive weeks
15848436|NCT04055181|Device|rTMS in major depressive disorders controls|"all procedures were identical to rTMS in major depressive disorders patients group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated."
15848437|NCT04055181|Device|rTMS in major depressive disorders patients|10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 27-s intervals with 20s intertrain interval. 20 minutes were administered each day (Monday-Friday) for 4 consecutive weeks
15848438|NCT04055168|Drug|AZD6615|AZD6615 (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects.
15848439|NCT04055168|Drug|Placebo|Placebo (dose 1, dose 2, or dose 3) will be administered as a single dose to the randomized subjects.
15848440|NCT04055142|Procedure|electrocoagulation|HIV homosexuals males with High-grade anal intraepithelial neoplasia will be randomized and electrocoagulation will be performed in 2-3 sessions (session every 2 weeks)
15848441|NCT04055142|Drug|cidofovir 1% topical ointment|HIV homosexuals males with High-grade anal intraepithelial neoplasia will be randomized and they will be treated with cidofovir 1% ointment (3 times per week during 8 weeks)
15848442|NCT04055142|Drug|sinecatechins 10% topical ointment|HIV homosexuals males with High-grade anal intraepithelial neoplasia will be randomized and they will be treated with sinecatechins 10% ointment (3 times per week during 8 weeks)
15848443|NCT04055129|Other|No interventions|Observational. Data will be gathered and analyzed on ligament laxity, EMG, kinetics and kinematics during a landing and jumping activity
15848444|NCT04055116|Drug|Buffered Lidocaine|Investigator will prepare 1:10 dilution of sodium bicarbonate to 2% lidocaine with 1:100,000 epinephrine on one occasion. 8.4% Sodium Bicarbonate will be used.
15848446|NCT04055090|Genetic|Long-Term Follow-Up of Patients who Received VM202|No study drug is administered in this study. Patients who received VM202 in a previous trial will be evaluated in this trial for long-term safety and efficacy.
15848447|NCT04055090|Drug|Long-Term Follow-Up of Patients who Received Placebo|No study drug is administered in this study. Patients who received Placebo in a previous trial will be evaluated in this trial for long-term safety and efficacy.
15848448|NCT04055077|Device|Low-flow nasal oxygenation (LFNO) ASA I|Active comparator LFNO: O2 flow 5 L/min, FiO2 40%
15848449|NCT04055077|Device|Low-flow nasal oxygenation (LFNO) ASA II|Active comparator LFNO: O2 flow 5 L/min, FiO2 40%
15848450|NCT04055077|Device|Low-flow nasal oxygenation (LFNO) ASA III|Active comparator LFNO: O2 flow 5 L/min, FiO2 40%
15848451|NCT04055077|Device|High-flow nasal oxygenation (HFNO) ASA I|Experimental HFNO: O2 flow 40 L/min, FiO2 40%
15848452|NCT04055077|Device|High-flow nasal oxygenation (HFNO) ASAII|Experimental HFNO: O2 flow 40 L/min, FiO2 40%
15848453|NCT04055077|Device|High-flow nasal oxygenation (HFNO) ASA III|Experimental HFNO: O2 flow 40 L/min, FiO2 40%
15848515|NCT04054557|Other|Best Practice|Receive 4 in-office visits with oncologist
15848516|NCT04054557|Other|Questionnaire Administration|Ancillary studies
15848517|NCT04054557|Other|Quality-of-Life Assessment|Ancillary studies
15848518|NCT04054557|Other|Survey Administration|Complete electronic survey
15848454|NCT04055064|Dietary Supplement|glucose control nutritional shake, nutrition education|Participants in the treatment group were educated about improving their diet by consuming more low-fat high-quality protein sources, vegetables, complex carbohydrates and less simple carbohydrates. They were also instructed to consume two servings (474 ml) of a commercially produced Glucose Control Nutritional Shake between meals throughout the day for 12 weeks or until complete healing. The supplements provided a total of 500 kilocalories, 28 grams of high-quality protein and essential vitamins and minerals.
15848455|NCT04055038|Drug|Platinum-Based Drug|Reintroduction of platinum-based chemotherapy
15848456|NCT04055038|Drug|Conventional chemotherapy|Conventional chemotherapy
15848457|NCT04055025|Other|Placebo|Four-hour liquid solid meal tests and a subsequent ad libitum meal during saline infusion.
15848458|NCT04055025|Other|Ghrelin|Four-hour liquid solid meal tests and a subsequent ad libitum meal during acyl-ghrelin infusion.
15848459|NCT04055012|Drug|Metformin|500mg tabs of Metformin Extended Release
15848460|NCT04055012|Drug|Placebo|Placebo Tabs
15848461|NCT04054999|Drug|Hydroxocobalamin|Hydroxocobalamin (Cyanokit): 5g IV infusion over 15 minutes
15848462|NCT04054999|Drug|Methylene Blue|Methylene blue (PROVAYBLUETM), 2 mg/kg IV bolus administered over 15 minutes
15848463|NCT04054986|Diagnostic Test|F-Var3 PET/CT|Participants will undergo up to 5 serial F-Var3 PET/CT scans within 25 minutes of the injection of 18F-Var3, 30, 60, 120 and 240 minutes after injection of the 18FVar3.
15848464|NCT04054986|Other|Blood draw|Collection of blood for research tests before the injection, 30, 60, 120 and 240 min after the injection.
15848465|NCT04054973|Drug|L-arginine|6000mg of L-arginine daily for 14 days
15848466|NCT04054973|Drug|Sapropterin Dihydrochloride|800mg of Kuvan daily for 14 days
15848467|NCT04054960|Device|Active tPCS|Active anodal tPCS will be given for 20 mins to motor cortex (M1) or supplementary motor area (SMA), based on our quantitative EEG findings.
15848468|NCT04054960|Device|Sham tPCS|For the sham condition, the electrode placement will be the same, but the electric current will be ramped down 5 seconds after the beginning of the stimulation.
15848469|NCT04054960|Drug|Levodopa tablet|We will give 3 tablets of Levodopa-Carbidopa (100/25).
15848470|NCT04054947|Behavioral|Suicide Prevention Program|Structured care management to improve adherence to discharge planning.
15848471|NCT04054934|Behavioral|Reversed Circadian Rhythm|Revered day/ night sleep cycle
15848472|NCT04054934|Behavioral|Normal Circadian Rhythm|Normal day/ night sleep cycle
15848473|NCT04054921|Drug|PTG-300|PTG-300 is a hepcidin Mimetic
15848474|NCT04054895|Device|Lead placed in the His-Purkinje system in order to achieve QRS shortening.|Physiologic pacing to achieve QRS shortening. If the patient has indication of stimulation (AV block), a backup lead will be implanted in the right ventricle. All patients will have a lead placed in the right atrium (except those that have permanent atrial fibrillation).
15848475|NCT04054895|Device|Lead is placed in a tributary of the coronary sinus.|Biventricular Resynchronization Therapy is the use of a pacemaker with two endocardial leads placed in the right atrium and right ventricle. The third lead is placed in a tributary of the coronary sinus.
15848476|NCT04054882|Biological|Sabin-IPV and DTaP|simultaneously administration of Sabin-IPV and DTaP
15848477|NCT04054882|Biological|Sabin-IPV|administration of Sabin-IPV only
15848478|NCT04054882|Biological|DTaP|administration of DTaP only
15848479|NCT04054869|Other|Bio-mechanically correct manual therapy at the cervical atlanto-axial joints|Participant is seated in a firm backed chair. The treating physical therapist mobilizes both the ipsi-lateral and contra-lateral atlanto-axial spinal segments congruently to the direction of rotational loss.
15848480|NCT04054869|Other|Bio-mechanically in-correct manual therapy at the cervical atlanto-axial joints|Participant is seated in a firm backed chair. The treating physical therapist mobilizes both the ipsi-lateral and contra-lateral atlanto-axial spinal segments in-congruently to the direction of rotational loss.
15848481|NCT04054856|Device|Body Sensor Network|"The Integrated Posture and Activity NEtwork by Medit Aachen (IPANEMA) Body Sensor Network (BSN) is a wireless sensor network with several sensor nodes. A sensor node consists of a base unit equipped with different sensor modalities: Acceleration sensor, Rotation rate sensor, Air pressure sensor, Photoplethysmography (PPG, optional), Galvanic Skin Response (GSR, optional) measurement. The sensor data is transmitted via a wireless 433/868 MHz ISM band radio link to the central radio node. From there, the data is transferred via a Bluetooth connection to a laptop or PC for processing. Three sensors are attached 1) to the wrist with a flexible Velcro strap, 2) hung around the neck on a specially designed collar and 3) worn loosely in the trouser pocket without further fixation or at the belt. The respective sensors are located in a closed, ergonomically shaped housing (size 70x40x20mm^3, approx. 35g) and have no electrically conductive contact to the skin surface of the test person."
15848482|NCT04054843|Diagnostic Test|Afamin|Plasma maternal afamin levels
15848483|NCT04054830|Drug|Voltaren Ophtha 1 mg/ml, GSK|Voltaren Ophtha 1 mg/ml, eye drops used 6 times daily for the 2 first weeks, tapering to 4 drops per day for the next 4 weeks. Depending on the clinical condition of the eye, the topical anti-inflammatory treatment will be reduced with 1 daily drop per week.
15848484|NCT04054830|Drug|Monopex 1 mg/ml, Théa|Monopex 1 mg/ml, eye drops used 6 times daily for the 2 first weeks, tapering to 4 drops per day for the next 4 weeks. Depending on the clinical condition of the eye, the topical anti-inflammatory treatment will be reduced with 1 daily drop per week.
15848485|NCT04054817|Device|Lamellar keratoplasty-ABCcolla® Collagen Ophthalmic Matrix|Lamellar keratoplasty was done by removing stromal layer, ABCcolla® Collagen Ophthalmic Matrix was sutured to the defective part of the cornea.
15848486|NCT04054804|Diagnostic Test|D-Foot|A digital foot check i assessed by using the software D-Foot.
15848487|NCT04054778|Behavioral|Avatar Therapy|Participants will be offered 9 individual and weekly sessions of 1 hour, which will be administered in an individual format by a licensed psychologist or psychiatrist experienced with psychosis patients. The therapy will consist in prompting participants to enter in a dialogue with their persecutor to better regulate their emotional responses. Over the course of the therapy, the avatar's speech and tone will gradually be changed by the therapist to echo participants' improved ability to regulate their emotions. That is, the avatar will progressively change from being abusive to becoming helpful and supportive. By doing so, the therapy will seek to reinforce participants' feeling of empowerment over their voices.
15848488|NCT04054778|Behavioral|Cognitive Behavioral Therapy|Participants will be offered 9 individual and weekly sessions of 1 hour, which will be administered in an individual format by a licensed psychologist or psychiatrist trained in Cognitive Behavioral Therapy for psychosis (CBTp). The program is derived and adapted from current evidence-based treatments for hallucinations. The 9 CBTp sessions will consist of a succession of learning modules and suggested task assignments.
15848489|NCT04054765|Device|videogame|Invite Only VR videogame
15848490|NCT04054765|Other|treatment as usual|treatment as usual
15848494|NCT04054739|Device|Robot-assisted gait training|intervention with robot-assisted gait training
15848495|NCT04054739|Device|Treadmill gait training|intervention with treadmill gait training
15848496|NCT04054726|Device|Active Transcranial pulsed current stimulation (tPCS)|Active tPCS will be delivered through a pair of saline-soaked (0.9% NaCl) surface sponge electrodes (7 × 5 cm2, for the anodal cerebellar electrode; 8 × 6 cm2 for the cathodal spinal electrode). Anode will be placed on the scalp over the cerebellum area (2 cm under the inion). Cathode will be placed over the dorsal cord. Stimulation will be given for 20 mins.
15848497|NCT04054726|Device|Sham Transcranial pulsed current stimulation (tPCS)|Sham tPCS will be delivered through a pair of saline-soaked (0.9% NaCl) surface sponge electrodes (7 × 5 cm2, for the anodal cerebellar electrode; 8 × 6 cm2 for the cathodal spinal electrode). Anode will be placed on the scalp over the cerebellum area (2 cm under the inion). Cathode will be placed over the dorsal cord. The electric current will be ramped down 5 seconds after the beginning of the stimulation to make this condition indistinguishable from the experimental active stimulation.
15848498|NCT04054713|Diagnostic Test|Acetic acid chromoendoscopy|Acetic acid is prepared at a concentration of 2.5% in a 20ml syringe, it will be applied with a 7 french spray catheter compatible with a working channel 2.8mm onwards, starting the proximal application When distally performing a uniform application on the area of intestinal metaplasia and the timed time for mucous visualization in search of areas of loss of acetowhitening begins, in case of finding such area will be registered the time in which there was loss of acetowhitening, the distance at which it is located from the upper dental arch in addition to the face on which the area is located, subsequently evaluation of the glandular pattern is performed only by classifying as normal or abnormal, once this evaluation has been carried out, biopsies are directed to these areas to be sent to the pathology service.
15848499|NCT04054713|Diagnostic Test|Seattle protocol|Take random biopsies by quadrants every 2 centimeters. Biopsy of the intestinal metaplasia areas 1cm above the esophagogastric junction will be initiated, taking tissue every 2cm from the four quadrants, separating the biopsies in different bottles based on the length in which they were taken, to later be sent to the pathology service.
15848500|NCT04054700|Device|distal upper rehabilitation robot|Intervention with distal upper rehabilitation robot
15848501|NCT04054700|Device|proximal upper rehabilitation robot|Intervention with proximal upper rehabilitation robot
15848502|NCT04054687|Drug|Tranexamic Acid|Enrolled patients will be placed in one of two groups: either the group receiving a cotton pledget soaked in (0.9%) saline or (100mg/1mL) TXA. Patients will initially be asked to gently blow their nose to remove any clots. Group 1 will receive the saline soaked pledget. After fifteen minutes the pledget will be removed. If patient continues to bleed within a reevaluation period of fifteen minutes, this will be deemed a 'failure' and the examiner will pack the nose with the method of his or her choice. Group 2 will receive the TXA soaked pledget and the procedure will continue like Group 1.
15848503|NCT04054687|Other|Placebo|This group will receive pledget soaked in saline. Protocol will continue as with TXA group.
15848504|NCT04054674|Procedure|Abutments with flat occlusal scheme preparation restored by lithium disilicate crowns|Clinical trials lacks information about flat occlusal preparation design in case of endodontically treated teeth. Therefore, this is tested during preparation when compared to planer occlusal preparation while the final restoration in both arms is lithium disilicate (e.max) crowns.
15848505|NCT04054661|Diagnostic Test|SD Biosensor STANDARD G6PD Test|The SD Biosensor G6PD Analyzer is designed to measure the quantitative determination of total hemoglobin concentration and G6PD enzymatic activity in fresh human whole blood specimens based on reflectometry assays in a point-of-care setting. The test is intended to aid in the identification of people with G6PD deficiency. The test is currently not licensed for use in the US and is considered an investigational product.
15848506|NCT04054661|Diagnostic Test|Pointe Scientific Test Kit|The Pointe Scientific test kit will serve as the reference assay to assess G6PD activity. Its intended use is for the quantitative, kinetic determination of G6PD in blood at 340 nm.
15848507|NCT04054661|Diagnostic Test|HemoCue System|The HemoCue hemoglobin (Hb) 201+ system is designed for quantitative point-of-care whole blood hemoglobin determination in primary care using a specially designed analyzer, the HemoCue Hb 201+ Analyzer, and specially designed microcuvettes, the HemoCue Hb 201+Microcuvettes.
15848508|NCT04054648|Other|Bedtime administration of the participant's pre-existing antihypertensive medications|Changing the administration time of once daily blood pressure lowering medications, one at a time as tolerated, from morning to bedtime.
15848509|NCT04054635|Device|silver diamine fluoride|Antibiotic liquid with anti-caries effects. A non-restorative option to manage cavitated caries lesions. Approved for clinical use in Canada in 2017.
15848510|NCT04054609|Diagnostic Test|FAZA PET/MRI scan|PET/MRI scan using radio tracer named 18F-Fluoroazomycin Arabinoside (FAZA) pre and post standard of care endovascular treatment for critical limb ischemia patients
15848511|NCT04054596|Behavioral|SME|The treatment group (TX) will complete 8 sessions of SME (2 sessions per week for 4 weeks), de-signed to teach the concepts of SG, SL and RP and the application of these techniques in daily life. Sessions are approximately 30-45 minutes long.
15848512|NCT04054583|Other|Renovation of long-term residential care living spaces|Living spaces of the long term care facility will be renovated.
15848513|NCT04054570|Other|No intervention|No Intervention
15848521|NCT04054544|Dietary Supplement|Gluten powder 4g|Gluten powder 4g oral BID
15848522|NCT04054531|Biological|KN046|IV infusion
15848523|NCT04054531|Drug|Paclitaxel|IV infusion
15848524|NCT04054531|Drug|Pemetrexed|IV infusion
15848525|NCT04054531|Drug|Carboplatin|IV infusion
15848526|NCT04054518|Drug|Durvalumab|Durvalumab (MEDI4736) will be supplied as a 500-mg vial solution for infusion after dilution.
15848527|NCT04054505|Dietary Supplement|EZPAK|One packet with breakfast for three months
15848528|NCT04054505|Dietary Supplement|Placebo|One packet with breakfast for three months
15848529|NCT04054492|Biological|Sabin-IPV+bOPV+bOPV|202 subjects were vaccinated with 1 dose of Sabin-IPV and 2 doses of bOPV at their age of 2/3/4 months old, respectively
15848530|NCT04054492|Biological|Sabin-IPV+Sabin-IPV+bOPV|197 subjects were vaccinated with 2 doses of Sabin-IPV and 1 dose of bOPV at their age of 2/3/4 months old, respectively
15848531|NCT04054492|Biological|Sabin-IPV+Sabin-IPV+Sabin-IPV|205 subjects were vaccinated with 3 doses of Sabin-IPV at their age of 2/3/4 months old, respectively
15848532|NCT04054479|Drug|Penehyclidine|Patients receive penehyclidine 10μg/kg(up to 0.5mg, diluted with normal saline to 0.1mg/ml) after anesthesia intubation.
15848533|NCT04054479|Drug|normal saline|Patients receive 0.1ml/kg normal saline(up to 5ml) after anesthesia intubation.
15848534|NCT04054466|Behavioral|Nursing Counseling in the change of Alcohol Consumption Behavior in patients receiving HAART|"It is a health intervention, performed by the nurse with the purpose of providing support or support to the patient's health care. The main objective of counseling is to improve adherence to treatment in patients who receive HAART but also consume alcoholic beverages.
~The components of the differentiated counseling according to the levels of consumption are consolidated according to the recommendations given by the World Health Organization (WHO) after the application of the AUDIT:
~Social consumption (sometime in life, in the last year or in the last month) = mainly education about consumer risks, its application will be bi-monthly."
15848535|NCT04054466|Behavioral|Habitual Counseling|Regular counseling provided to patients receiving HAART, based on education and guidance to comply with antiretroviral treatment
15848536|NCT04054453|Combination Product|Intra-partum care bundle invoking 4 elements|Care bundle involving all the 4 elements
15848537|NCT04054427|Device|IOL implantation experimental|Implantation of trifocal IOL POD L GF consisting of hydrophobic material
15848538|NCT04054414|Drug|Normal Saline along with standard treatment|The arm is for active comparison for PMZ-1620 (sovateltide), an endothelin-B receptor agonist. PMZ-1620 has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in cerebral ischemic stroke patients. Normal saline (vehicle) with standard treatment will be provided.
15848539|NCT04054414|Drug|PMZ-1620 along with standard treatment|PMZ-1620 (sovateltide) is an endothelin-B receptor agonist. PMZ-1620 has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in cerebral ischemic stroke patients.
15848540|NCT04054388|Behavioral|LINE re-education|
15848541|NCT04054375|Drug|Prednisone|Subjects will be asked to take weekly GC oral prednisone dosed based on weight (1mg/kg for patients who weigh less than or equal to 70 kg and 0.75 mg/kg for patients who weigh more than 70 kg). Subjects will also be instructed to take their weekly prednisone on Mondays after their last meal between 7 and 9 PM
15848542|NCT04054362|Drug|Paclitaxel protein bound|paclitaxel protein bound and gemcitabine with or without cisplatin until stable or progressive disease at which point paricalcitol will be introduced
15848543|NCT04054362|Drug|Cisplatin|paclitaxel protein bound and gemcitabine with or without cisplatin until stable or progressive disease at which point paricalcitol will be introduced
15848544|NCT04054362|Drug|Gemcitabine|paclitaxel protein bound and gemcitabine with or without cisplatin until stable or progressive disease at which point paricalcitol will be introduced
15848545|NCT04054362|Drug|Paricalcitol|paclitaxel protein bound and gemcitabine with or without cisplatin until stable or progressive disease at which point paricalcitol will be introduced
15848546|NCT04054349|Other|Low FODMAP diet|The low FODMAP diet group reduced the intake of FODMAP(fermentable oligosaccharides, disaccharides, monosaccharides, and polyols)
15848547|NCT04054336|Behavioral|Inhibit AAT|Participants receive an Ipad, on which the app is installed. They are instructed to train for a period of three weeks for at least 15 minutes a day.
15848548|NCT04054336|Behavioral|classical AAT|Participants receive an Ipad, on which the app is installed. They are instructed to train for a period of three weeks for at least 15 minutes a day.
15848549|NCT04054336|Behavioral|Control Group|Participants receive an Ipad, on which the app is installed. They are instructed to train for a period of three weeks for at least 15 minutes a day.
15848550|NCT04054323|Behavioral|Physical Activity Intervention|The physical activity intervention will include basic skill training during which the participant will be instructed on the use of (1) the activPAL physical activity device for the tracking of time spent sitting, standing, and walking, (2) tools to monitor exercise intensity, including ratings of perceived exertion, (3) an exercise calendar for setting a specific schedule for the completion of the home exercise program using the exercise videos posted on our website, (4) use of the exercise equipment that will be used in the home program (Therabands), and (5) strategies for reduction of sedentary behavior that target prolonged sitting and encourages frequent activity breaks. Duration of intervention is 6 months.
15848551|NCT04054310|Diagnostic Test|Liver Multi Scan|MRI to create cT1, T2* and PDFF images of patients liver.
15848552|NCT04054297|Behavioral|High GI/SFA diet|Subject will adhere to a 2 week high GI/SFA diet.
15848553|NCT04054297|Behavioral|Low GI/SFA diet|Subject will adhere to a 2 week low GI/SFA diet.
15848554|NCT04054284|Dietary Supplement|Antidiabetic Herbal Tea|Patients will be instructed to take 250 mL of freshly prepared tea (1 tea spoon or 3 g of tea, pour over 250 mL of boiling water and leave aside for 15 min) 2 times per day during 12 weeks. The first tea needs to be taken in the morning prior any meal. The second can be taken at any time during the day but with at least 4 hour difference from the first cup.
15848595|NCT04053920|Behavioral|High Load Resistance exercise|leg extension, leg press, leg curl and calf press
15848700|NCT04053023|Drug|Obeticholic acid|Obeticholic acid is available as a tablet with a unit dose strength of 10 mg (or 5 mg dependent on evaluation of Part A).
15848555|NCT04054284|Dietary Supplement|Herbal Tea|Patients will be instructed to take 250 mL of freshly prepared tea (1 tea spoon or 3 g of tea, pour over 250 mL of boiling water and leave aside for 15 min) 2 times per day during 12 weeks. The first tea needs to be taken in the morning prior any meal. The second can be taken at any time during the day but with at least 4 hour difference from the first cup.
15848556|NCT04054258|Device|App support Programme (ASP) group|All subjects will continue their usual care with prescribed medical treatments, ED nursing advice, and follow-ups as indicated. In addition to the above usual care, bi-weekly 20 minutes telephone follow ups will be provided by a trained research nurse (B) up to 3 months. Patients can ask related health problems if any. The nurse will address their problem by providing advices or refer them to the ED follow up clinic if the problems cannot be solved by the nurse.
15848557|NCT04054245|Drug|LOXL2 Inhibitor PAT-1251|Given PO
15848558|NCT04054245|Other|Quality-of-Life Assessment|Ancillary studies
15848559|NCT04054245|Other|Questionnaire Administration|Ancillary studies
15848560|NCT04054232|Other|High PAD risk Alert|"In this message sent via the electronic health record, a participant's primary care physician will receive a message that details the following:
~Participant flagged as having a high risk of peripheral artery disease based on their electronic health record data
~What peripheral artery disease is and why diagnosis may be important
~Recommendation to refer to a vascular medicine specialist or order ankle brachial index for definitive diagnosis
~The option to opt out if the potential participant is not deemed a candidate for inclusion in the study with a short explanation of why the potential participant should not be included."
15848561|NCT04054219|Device|Bone graft substitute|Evaluation of a device made of deproteinized bovine bone material as bone graft substitute in different indications requiring bone grafting procedures before implant placement
15848562|NCT04054206|Drug|MN-166|MN-166 (ibudilast) is an orally available small molecule drug currently being investigated for human treatment in multiple sclerosis, amyotrophic lateral sclerosis, glioblastoma, and alcohol and drug use disorders.
15848563|NCT04054193|Drug|Fosaprepitant Dimeglumine|Participants received IV fosaprepitant dimeglumine ≤115 mg on Day 1 and ≤80 mg on Days 2 and 3 (dose adjusted for age).
15848564|NCT04054193|Drug|5-HT3 antagonist|All participants received an oral 5-hydroxytryptamine (serotonin; [5-HT]) 3 receptor antagonist on Day 1 and had the option to take on Days 2-3. The dose was as per product label or standard of care.
15848565|NCT04054193|Drug|Dexamethasone|Participants received optional oral dexamethasone at the investigator's discretion according to product label or standard of care.
15848566|NCT04054180|Other|CPAP associated with connected devices: blood pressure monitor , scales and activity monitor|CPAP associated with connected devices: blood pressure monitor , PROMs and activity monitor Patients will use their connected devices for one year. Data from the connected devices will be transmitted to their smartphone application Sefam Access. At the beginning of the study, patients will have a dietary assessment and start a support program for nutrition counselling and physical activity. At each study visit the dietician and physical exercise coach will give the patient advices on diet and for adjusting physical activity.
15848567|NCT04054167|Drug|Low Dose Radiation Therapy|Undergo ultra low dose radiation
15848568|NCT04054154|Device|Shear Wave Elastography|Undergo shear wave elastography
15848569|NCT04054154|Procedure|Tumor Interstitial Fluid Pressure Measurement|Undergo tumor pressure measurement
15848570|NCT04054141|Device|Mag Stim|rTMS
15848571|NCT04054128|Drug|Sodium Bicarbonate 7.5% Injection|Sodium bicarbonate solution for catheter lock; 7.5% sodium bicarbonate solution will be used for catheter lock in both catheter lumens, 1.9 mL in each catheter lumen will be infused after hemodialysis treatment during 3 months.
15848572|NCT04054128|Drug|Heparin Sodium, 1000 Units/mL Injectable Solution 1|Heparin for catheter lock: 1000 u/mL heparin solution will be used for catheter lock in both catheter lumens as standard treatment, 1.9 mL in each catheter lumen will be infused after hemodialysis treatment during 3 months.
15848573|NCT04054115|Drug|Alprostadil 5 MCG Injection|During the MRI, Alprostadil infusion will be started and titrated to the target dose, ensuring there is a less than 20% drop in blood pressure from baseline. Repeat pressure and MRI flow measurements once Alprostadil reaches 0.1mcg/kg/min.
15848574|NCT04054102|Other|Robot and tDCS on-line|Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot for 5 times a week for 4 weeks
15848575|NCT04054102|Other|Robot and sham tDCS|Combined sham tDCS and upper extremity rehabilitation robot for 5 times a week for 4 weeks
15848576|NCT04054089|Drug|Bictegravir 50 MG / Emtricitabine 200 MG / Tenofovir Alafenamide 25 MG [Biktarvy]|Biktarvy OD
15848577|NCT04054089|Drug|dolutegravir 50 mg / lamivudine 300 mg|DTG +3TC (Dovato OD)
15848578|NCT04054076|Device|Prefabricated insoles|The participants received prefabricated insoles
15848579|NCT04054076|Device|Soft custom-made insoles|The participants received soft custom-made insoles
15848580|NCT04054076|Device|Hard custom-made insoles|The participants received hard custom-made insoles
15848581|NCT04054063|Drug|HSK3486+ etomidate|
15848582|NCT04054050|Other|Light therapy|Bright light (10,000 lux) therapy will be administered via a light box.
15848583|NCT04054037|Other|No intervention|This is an observation study, no intervention will be indicated during diagnosis and treatment.
15848584|NCT04054024|Drug|Erenumab|140 mg Erenumab
15848585|NCT04054024|Drug|Placebos|Saline
15848586|NCT04054011|Drug|Deoxycholic Acid|Deoxycholic acid (Kybella) 10 mg/ mL subcutaneous
15848587|NCT04053998|Procedure|Pancreaticoduodenectomy with portal vein resection|Pancreatic surgery with vein resection to achieve disease clearance.
15848588|NCT04053985|Combination Product|TAI combine lenvatinib|TAI combine lenvatinib
15848589|NCT04053985|Drug|Lenvatinib|lenvatinib only
15848590|NCT04053972|Drug|Lenvatinib|oral lenvatinib after hepatectomy
15848591|NCT04053959|Drug|AI assisted insulin system|The patients receive the insulin regime set by AI assisted insulin titration system
15848592|NCT04053959|Drug|Physician based insulin regime|Patients receive the insulin regime recommended by physicians
15848593|NCT04053946|Device|Next Science Wounds Gels|SurgX will be applied once at closure while BlastX will be applied everyday until day 28 with each dressing change.
15848594|NCT04053920|Behavioral|Low Load Resistance exercise|leg extension, leg press, leg curl and calf press
15848596|NCT04053907|Other|Community Case Management|Community Case Management (CCM), consisting of community health workers able to diagnose malaria by standard RDTs and treating positive individuals with artemether-lumefantrine (AL), according to national guidelines.
15848597|NCT04053907|Other|Weekly fever screening and treatment|Consists of weekly visits by trained VHW who will screen for fever by taking the axillary temperature. If the body temperature is ≥37.5°C, a standard RDT will be performed and, if positive, the individual will be treated with AL, according to national guidelines.
15848598|NCT04053907|Other|Monthly malaria screening|CCM plus monthly screening of the whole population with high sensitive RDT (HS-RDT); positive individuals will be treated with AL regardless of symptoms (MSAT).
15848599|NCT04053907|Other|MDA|CCM plus 3 monthly rounds of MDA with dihydroartemisinin-piperaquine (DP) starting during the dry season, before the malaria transmission season starts.
15848601|NCT04053868|Other|JUUL|Electronic Cigarette
15848602|NCT04053868|Other|Tobacco|Tobacco Cigarette
15848603|NCT04053855|Biological|Urinary sample|Urinary sample (100 ml) will be collected in the urology department to analysis urinary exosomes.
15848604|NCT04053842|Diagnostic Test|PET Scan|PET imaging uses small amounts of a radioactive substance called a tracer to look for disease in the body. The radioactive substance used in this study is [F-18]-DCFPyL.
15848605|NCT04053842|Drug|[F-18]-DCFPyL Injection|[F-18]-DCFPyL is given by intravenous (IV) injection into the arm. It travels through the blood stream where it is rapidly taken up by prostate cancer cells and emits tiny, positively charged particles (called positrons) that produce signals into the body. These signals are detected by the PET component of the PET/MRI scanner.
15848606|NCT04053842|Diagnostic Test|Sodium MRI|Sodium MRI uses magnetic waves and a specially-designed rectal probe to measure the sodium concentration (amount of salt) in the prostate. Previous research has shown that higher sodium concentrations in the prostate might be a sign of more aggressive cancer.
15848607|NCT04053842|Diagnostic Test|Multiparametric MRI|MRI is a common medical diagnostic tool that uses magnetic waves and a contrast agent (dye) called Gadovist to take pictures of body tissue.
15848608|NCT04053829|Device|HOLOBalance|"The HOLOBalance tele-rehabilitation system will be used to deliver an evidence based, multi-sensory balance rehabilitation programme to participants, and will deliver a series of exercises prescribed by an expert balance physiotherapist following an initial balance assessment.
~The HOLOBalance system will use a head mounted augmented reality display to deliver exercises and games to participants and will record task performance via a combination of body worn sensors and a depth camera. The HOLOBalance tele-rehabilitation system will provide feedback to the supervising clinical team regarding task performance, participant usage and user feedback. The system will have daily presence in the users' home with users expected to complete their prescribed rehabilitation on a daily basis, which mirrors the prescribed exercise routines often provided by balance physiotherapists."
15848609|NCT04053829|Other|OTAGO Home Exercise Programme|The OTAGO is a systematic, progressive strength and balance training programme and is supported by a comprehensive workbook that provides written and pictorial instructions for each exercise. It is well-established and widely used in clinical practice in the UK, and has been shown to reduce falls rate in older adults by 35-40%. It is well tolerated in older adults in community settings with good adherence rates.The OTAGO has also been used as the standard intervention in previous investigations of MSR interventions in older adults. To match intervention and control interventions, participants in the OTAGO group will be asked to complete the OTAGO programme every day for the duration of the 8 week programme.
15848610|NCT04053816|Drug|Potassium|"The trial treatment will start when patients are admitted to the intensive care unit after their surgery. The patient will undergo regular blood investigations, as per current practice. The frequency of K+ monitoring while on ICU will be according to clinician / nursing staff preference.
~Potassium supplementation will be according to local hospital protocols. This can be either via an intravenous infusion or as a tablet. Patients will otherwise be treated as per current hospital protocol."
15848611|NCT04053803|Drug|IMR-687|Oral administration of once daily IMR-687
15848612|NCT04053790|Drug|lactobacillus LB|administration of different doses of Lactobacillus LB according to the treatment groups described previously
15848613|NCT04053790|Other|placebo|a tablet of placebo every 12 hours given by mouth
15848614|NCT04053777|Device|non-invasive ventilation|Noninvasive positive pressure ventilation used assist/control mode to treat chronic respiratory disease.
15848615|NCT04053764|Drug|Crizanlizuamb|Crizanlizumab is a concentrate for solution for infusion, i.v. use. Supplied in single use 10 mL vials at a concentration of 10 mg/mL. One vial contains 100 mg of crizanlizumab
15848616|NCT04053764|Drug|Standard of Care|HU/HC (hydroxyurea/hydroxycarbamide) and/or ACE (angiotensin-converting enzyme) inhibitors and/or ARBs (angiotensin-receptor blocker)
15848617|NCT04053751|Procedure|closed suctioning system|a randomized allocated patient will be monitored for two days. Closed suctioning system will evaluate as experimental group. open suctioning system will evaluate as control group.
15848618|NCT04053738|Device|Anti-snoring bed|The mattress shape is adjusted using a custom made intelligent anti-snoring bed, which is able to detect snoring sound and change the position of the user whenever snoring occurs.
15848619|NCT04053712|Drug|Glucagon|GlucaGen(R), Novo Nordisk, DK
15848620|NCT04053712|Device|Closed-loop system|Closed-loop system comprise of two DANA RS (R) insulin pumps (FiAsp-GlucaGen vs FiAsp-saline), one DexCom G6 sensor, and a smartphone for the control algorithm.
15848621|NCT04053699|Drug|VWF-containing products|Active substances: VWF concentrates, VWF/FVIII concentrates, Cryoprecipitate VWF-containing products licensed in each participating country
15848622|NCT04053686|Behavioral|Breaks|3-min breaks every half hour at work
15848624|NCT04053660|Procedure|Non-surgical periodontal treatment|Mechanical non-surgical treatment were performed
15848625|NCT04053647|Other|Non-interventional study|Non-interventional study
15848626|NCT04053634|Biological|Benralizumab|Benralizumab solution for injection in accessorized prefilled syringe (APFS) will be administered subcutaneously (SC) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks until the end of treatment.
15848627|NCT04053634|Biological|Placebo|Matching placebo will be administered subcutaneously with accessorized prefilled syringe (APFS) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks until the end of treatment.
15848628|NCT04053621|Dietary Supplement|Thiamine pyrophosphate|12 weeks of weekly dose of 1 gram of thiamine pyrophosphate administered in an intravenous manner with saline solution
15848629|NCT04053621|Other|Placebo|12 weeks of weekly dose of 275 ml of saline solution administered in an intravenous manner
15848630|NCT04053621|Drug|Metformin|All participants will continue taking metformin in their previous established tolerated dose for the duration of the study
15848631|NCT04053595|Diagnostic Test|Dynamic parameters of fluid responsiveness protocol|Dynamic parameter of fluid responsiveness (pulse pressure variation/stroke volume variation) are used to optimize hemodynamics intraoperatively and during the first 6 hours postoperatively when appropriate. A cutoff of 12% is used to predict an increase of stroke volume >10% after fluid administration.
15848632|NCT04053595|Diagnostic Test|Estimated oxygen extraction protocol|Oxygen extraction is estimated by the difference of arterial oxygen saturation and central venous oxygen saturation divided by arterial oxygen saturation. A cutoff of 27% is used as a marker of inadequate tissue perfusion requiring hemodynamic optimization.
15848633|NCT04053582|Behavioral|AMT|The session will be done on an individual basis. AMT group will receive neurofeedback training from the PCC while focusing on the physical sensations of the breath. The session will last one hour, including 3 neurofeedback runs during which subjects will undergo three conditions across three consecutive blocks: Rest (30s), Describe (view an adjective and decide whether the word describes them; 20s), and Focus on the Breath with neurofeedback (70s).
15848634|NCT04053582|Behavioral|Sham|The session will be done on an individual basis. Sham group will receive artificial neurofeedback while focusing on the physical sensations of the breath. The session will last one hour, including 3 sham neurofeedback runs during which subjects will undergo three conditions across three consecutive blocks: Rest (30s), Describe (view an adjective and decide whether the word describes them; 20s), and Focus on the Breath with artificial neurofeedback (70s).
15848635|NCT04053569|Dietary Supplement|Table Grape supplement|5g/Kg of table grape for four weeks with dietary recommendations along with a strict restriction of fruits and limitation of other foods containing polyphenols.
15848636|NCT04053543|Drug|CXA-10|(10-nitro-9(E)-octadec-9enoic acid)
15848637|NCT04053530|Other|restorative materials|glass ionomer and bulk fill flowable composite
15848638|NCT04053517|Other|Medical Chart Review|Medical chart is reviewed
15848639|NCT04053517|Other|Quality-of-Life Assessment|Ancillary studies
15848640|NCT04053517|Other|Questionnaire Administration|Ancillary studies
15848641|NCT04053504|Behavioral|Family Teamwork-Peer Delivery|Children with T1D and their parent will participate in 6 in-person FT-P group sessions during a 12-month period. Parents will also participate in monthly telephone support calls with a Parent Leader during the 12-month intervention period.
15848642|NCT04053491|Procedure|Hand surgery under regional anesthesia|In both groups, patients will benefit from an initial standardized bolus (long-acting local anesthetic, ropivacaine) to cover the operative period, via the allocated approach. Ultrasound guidance and the recommended standards monitors will be used in both groups. After the initial bolus, a catheter will be inserted via the allocated approach. Surgery will be done under regional anesthesia alone, unless there is a medical contraindication or if the patient asks for general anesthesia. Post-operative analgesia will be standardized with regular paracetamol, regular NSAID (Nonsteroidal anti-inflammatory drugs) and oxycodone if needed. The local anesthetics perfusion will be standardized. There will be a medical follow up at 24 and 48 hours where data will be collected.
15848643|NCT04053478|Drug|Ephedrine|Ephedrine in solution, 10 -10m to 10 -3M
15848644|NCT04053478|Drug|Phenylephrine|Phenylephrine, 10 -10m to 10 -3M
15848645|NCT04053478|Drug|Norepinephrine|Norepinephrine, 10 -10m to 10 -3M
15848646|NCT04053465|Other|Heat acclimation|14 days of aerobic exercise in a hot environment
15848647|NCT04053465|Other|Exercise in a cool environment|14 days of aerobic exercise in a cool environment
15848648|NCT04053452|Diagnostic Test|Peripheral nerve ultrasound|Ultrasound of the bilateral ulnar nerves, median nerves, vagus nerves, and C6 and C7 nerve roots will be performed.
15848649|NCT04053452|Diagnostic Test|Measurement of strength|Strength will be assessed by physical examination and recorded using Medical Research Council (MRC) scale, and a hand dynamometer will be used to measure grip strength.
15848650|NCT04053439|Other|Blood test for determination of CHIP|Patients will have one additional blood draw to be sent for DNA extraction and sequencing for CHIP.
15848651|NCT04053426|Other|Implementation of agitation care algorithm|Following the agitation care algorithm care professional adapt their behavior regarding agitation
15848652|NCT04053413|Other|Decision Aid|The decision aid is a series of web pages that includes videos, questions, and evidence-based information. The decision aid is designed to help women think about what matters to them and what questions they may have for their doctor or midwife. At the end, they receive a summary of which way they are leaning and what matters most to them.
15848653|NCT04053400|Drug|Ketamine|
15848654|NCT04053387|Drug|DMVT-505 (tapinarof cream, 1%)|Tapinarof cream, 1%, applied once daily
15848655|NCT04053374|Other|Blood sampling|Blood sampling +/- CSF sampling
15848656|NCT04053361|Procedure|Catheter ablation|Catheter ablation of atrial fibrillation or atrial tachykardie related to atrial fibrillation with use of radiofrequency energy.
15848657|NCT04053348|Procedure|Home-based rehabilitation program using mobile app|Home-based rehabilitation program
15848694|NCT04053075|Other|Enhanced cluster detection|Hospitals will use an automated statistical cluster detection tool in addition to routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.
15848695|NCT04053062|Biological|LIGHT-PSMA-CART cells|LIGHT-PSMA-CART cells will be given IV at split doses
15848696|NCT04053049|Other|Diet|Meals composed of either high fat vs. high carbohydrate and semi-solid vs. solid
15848697|NCT04053036|Drug|MDMA|Participants will be given 1.5mg/kg of MDMA
15848698|NCT04053036|Drug|Placebo oral tablet|Participants will be given a placebo capsule that will only contain lactose.
15848699|NCT04053023|Drug|GSK2330672 (linerixibat)|GSK2330672 is available as a tablet with unit dose strength of 45 mg.
15849108|NCT04049786|Drug|Carvedilol 25mg|Single-dose of carvedilol 25 mg are being administrated orally.
15848658|NCT04053335|Behavioral|Multicomponent Physician Performance Peer-Comparison Feedback Intervention|"The intervention will consist of 5 components delivered simultaneously
~Clinical Leadership Team: Each site will develop a Clinical Leadership Team (CLT), typically consisting of quality officers, clinician champions, etc. to implement and monitor the intervention
~Speaker Series: VCHI will offer the CLTs access to national experts via a CME-approved speaker series and office hours to support the intervention.
~Education Materials: The CLTs will distribute clinician and consumer education throughout the health systems calling to avoid 7 low-value services.
~Clinician Report Cards: VCHI will distribute quarterly customized clinician performance report cards to the CLTs teams using the Milliman Health Waste Calculator and Virginia APCD
~Quality improvement training: The intervention will provide the CLTs with in-person quality improvement and clinician performance feedback training, using principles of self-determination theory, and will include monthly check-in calls"
15848659|NCT04053322|Drug|Durvalumab|Durvalumab will start 4 weeks after the first dose of olaparib (Cycle 2, Day 1) at 1500 mg intravenous (IV) every 4 weeks.
15848660|NCT04053322|Drug|Olaparib|2 x 150 mg tablets taken in the morning and in the evening orally (2 X 300 mg daily)
15848661|NCT04053322|Drug|Fulvestrant|Two intramuscular injections of 250 mg each on Cycle 1 Days 1 and 15, and then Day 1 of each subsequent 28-day cycle.
15848662|NCT04053296|Other|Observational study|We follow up the results of patients.
15848663|NCT04053283|Biological|NG-641|NG-641 is an oncolytic adenoviral vector which expresses a FAP-TAc antibody together with an immune enhancer module (CXCL9/CXCL10/IFNα).
15848664|NCT04053283|Biological|NG-641|NG-641 is an oncolytic adenoviral vector which expresses a FAP-TAc antibody together with an immune enhancer module (CXCL9/CXCL10/IFNα).
15848665|NCT04053270|Drug|Afamelanotide|16mg subcutaneous implant
15848666|NCT04053270|Drug|Placebo|Placebo subcutaneous implant
15848667|NCT04053257|Other|Hand hygiene compliance observation with video camera surveillance system and performance feedback of the HH rates to HCWs|"Intervention:
~We will report baseline HH compliance rates and HAI rates to HCWs during a meeting where all HCWs are present. During this meeting we will remind major infection control measures, give examples of common mistakes they made without violating personal privacy rights of HCWs and patients."
15848668|NCT04053244|Behavioral|internet-based cognitive behavioural therapy|Designed for general clinical use (but not specifically cardiac patients), it consists of 5 online modules outlining cognitive-behavioural skills for depression, completed over 7-8 weeks. The participants will be guided step-wise through the modules by the therapist. Participants can work more or less at their own pace, but are expected to proceed to the next module within 1-2 weeks. Because the content is identical for each participant, fidelity to the web-based component of the intervention is ensured.
15848669|NCT04053231|Other|liver resection|all type of liver surgical procedures
15848670|NCT04053218|Combination Product|Exercise plus omega-3 supplement|Supervised aerobic exercise and omega-3 supplement
15848671|NCT04053218|Dietary Supplement|Placebo|Olive oil placebo
15848672|NCT04053205|Drug|Gentuximab|Administered intravenously (IV)
15848673|NCT04053205|Drug|Paclitaxel|Administered intravenously (IV)
15848674|NCT04053192|Procedure|BAV|BAV
15848675|NCT04053192|Procedure|BAV + TAVR|BAV + TAVR
15848676|NCT04053192|Procedure|SAVR|Surgical aortic valve replacement (SAVR)
15848677|NCT04053179|Device|Patch validation|Use of connected patch to collect blood pressure, heart rate, respiratory rate, arterial oxygen saturation and temperature
15848678|NCT04053166|Device|individualized home-based physical activity|Subjects will have to reach a daily goal in number of steps, based on the initial evaluation, during 6 months . They will wear connected wrists, and will be contacted twice a month by phone call by an adapted physical activity to revaluate these goals.
15848679|NCT04053166|Other|MRI|An MRI will be performed for each patient at the end of the study to identify IPH and other features of histological vulnerability (lipid core, fibrous cap integrity and calcifications).
15848680|NCT04053166|Biological|blood sampling|Blood will be collected, to analyse monocyte phenotype by flow cytometry, blood rheology by ektacytometry, coagulation by rotational thromboelastometry (ROTEM). Plasma will be extracted from blood to assess inflammation, oxidative stress and antioxidant markers.
15848681|NCT04053166|Other|Questionnaires|sedentary, physical activity, nutrition and quality of life questionnaire will be performed fo each patient.
15848682|NCT04053166|Other|6-minute walk test|The 6-minute walk test is a simple, individualized test that measures how fast a patient walks on a flat, hard surface for 6 minutes.
15848683|NCT04053153|Device|Exercise equipment (a musical instrument that is based on the Medical Didgeridoo)|exercise equipment (a musical instrument that is based on the Medical Didgeridoo)
15848684|NCT04053140|Device|Microneedle array|The microneedle biosensor will be sited peripherally (on the non-dominant arm) for the duration of the study. It will then be removed.
15848685|NCT04053140|Device|Microneedle array and closed-loop control of penicillin delivery|The microneedle biosensor will be sited peripherally (on the non-dominant arm) for the duration of the study. It will then be removed. Microneedle data will be used to titrate benzylpenicillin dosage according to PK-PD target.
15848686|NCT04053140|Drug|Penicillin G_1200mg|Benzylpenicillin IV 1200mg administered every 4 hours.
15848687|NCT04053140|Drug|Penicillin G_2400mg|Benzylpenicillin IV administered in intermittent dosing schedule. Dosage to be determined by closed-loop algorithm. Limits set to 2400mg every 4 hours.
15848688|NCT04053140|Drug|Penicillin G_600mg/hr|Benzylpenicillin IV administered in continuous dosing schedule. Dosage to be determined by closed-loop algorithm. Initial loading dose, and limits set to 600mg/hr.
15848689|NCT04053127|Device|RAVANS|Electrical stimulation of somatosensory vagal afferent receptors in the ear modulated by respiration.
15848690|NCT04053114|Other|DNA and RNA extraction from FFPE or frozen tissue sample|Next generation sequencing (NGS)
15848691|NCT04053101|Device|PET CT|Every patient undergoing a PET CT at the time of diagnosis of muscle invasive bladder cancer from January 2005 to December 2017 in Bordeaux (Institut Bergonié and University Hospital).
15848692|NCT04053088|Device|INSPIRIS RESILIA Aortic Valve™|Collection of patient data from patients undergoing Surgical Aortic Valve Replacement (SAVR) by usage of the INSPIRIS RESILIA aortic valve™
15848693|NCT04053075|Other|Routine cluster detection|Hospitals will use routine practices for cluster detection with a structured cluster response protocol when a cluster is detected.
15848701|NCT04053010|Biological|Sabin-IPV and DTaP|Sabin-IPV +DTaP at the age of 3/4/5 months old respectively
15848702|NCT04053010|Biological|Sabin-IPV|Sabin-IPV only at the age of 3/4/5 months old respectively
15848703|NCT04053010|Biological|DTaP|DTaP only at the age of 3/4/5 months old respectively
15848704|NCT04052997|Drug|Camidanlumab Tesirine|Intravenous Infusion
15848705|NCT04052984|Procedure|Delayed umbilical clamping and immediate skin-to-skin contact after birth by caesarean section|Mother: Placement of the insulating surgical arch was on the skin, between the abdomen and the thorax, electrocautery plate on the back, the gown superimposed, non-invasive blood pressure monitoring in legs and ear oximetry. The newborn was placed immediately on the mother's chest, passing it under the insulating arch and removing the mother's gown. Non-invasive monitoring was initiated with preductal pulse oximetry. The obstetrician cut the umbilical cord by not feeling the beats of the cord, or until 5 minutes. The newborn was reanimated without separating the baby from his mother. The temperature was taken with an infrared thermometer. Pulse oximetry was recorded. The newborn was colocated to the mother's breast as soon as possible, even if the mother was still in surgery. The mother's transfer to her room was with her baby skin to skin. The support staff was instructed not to separate the newborn until breast feeding occur for the first time or the mother required it.
15848706|NCT04052971|Drug|ABN401- Escalation Phase|Dose administration: Escalation Phase The regular dose levels of ABN401 will range from 50 mg to 1800 mg QD daily for 21 days.
15848707|NCT04052971|Drug|ABN401- Expansion Phase|Dose administration: Expansion Phase The expansion phase of the study will use the dose and schedule determined to be most appropriate in the dose escalation portion of the study. This may be the MTD and/or the RP2D and will consist of cohorts of patients representing various c-Met-amplification or mutant tumor types of interest.
15848708|NCT04052958|Device|IMT - inspiratory muscle training|respiratory strength or indurance training with respiratory therapy device
15848709|NCT04052945|Procedure|SPA acupuncture|"For patients in the AA group, acupuncture was performed at a selected point in the SPG by inserting the needle from the lower border of the zygomatic arch, posterior to the suture protuberance between the zygomatic process and temporal process. The needle was directed obliquely anteriorly, until nearly the whole needle was beneath the skin, and then rotated until the patient felt de-qi sensations .
~The patients in the AA group received four courses of active acupuncture(visit 1,2,3 and 4) within first two weeks, and then followed-up for a further 2 weeks (visit 5 and visit 6 )."
15848710|NCT04052945|Procedure|sham acupuncture|"For patients in the SA group, the needle was inserted at the same acupuncture point as for patients in the AA group, but to a depth of only 2-3cm and the procedure of rotating, twirling and thrusting the needle was repeated. During the acupuncture process, the acupuncturist sat on the side of the participant, where the patient could neither see the acupuncturist's face nor the length of the needle.
~The patients in the SA group received four courses of active acupuncture(visit 1,2,3 and 4) with first two weeks, and then followed-up for a further 2 weeks (visit 5 and visit 6)."
15848711|NCT04052932|Drug|SHR4640 dose1|tablets，dose1，QD
15848712|NCT04052932|Drug|SHR4640 dose2|tablets，dose2，QD
15848713|NCT04052932|Drug|Placebo oral tablet|tablets，QD
15848714|NCT04052932|Drug|Allopurinol 300 MG|tablets，300mg，QD
15848715|NCT04052919|Other|Cardiac dysfunction in adolescents with type 1 diabetes|"to identify specific parameters related to glucoregulation which correlate with cardiac function and structure in adolescent with T1DM.
~In T1DM, exercise training to have beneficial effects on HbA1c levels, cardiovascular risk profile.
~To evaluate the association between cardiac function/structure and cardiopulmonary exercise capacity in adolescent T1DM patients (in the perspective of their physical activity behavior). This study thus may provide greater insights in the etiology and consequences of a disturbed cardiac function/structure in adolescents with T1DM."
15848716|NCT04052906|Other|Training|Planned Inhaler Medication Trainning
15848717|NCT04052893|Procedure|Expanded Mckissock surgery|Expanded Mckissock surgery: (1) According to patient's preoperative imaging results and subjective expectations of their own breast morphology, the incision design and breast surface marking will be performed under the standing position. (2) After general anesthesia, the upper limbs will be abducted, and the upper body will be tilted by 15°-20° to dermatize the labeled skin around and below the areola. (3) The medial and lateral flaps will be dissociated to remove the total gland with nipple and areola preserved. (4) The cutting-edge of nipple-areola complex will be sent for cancer screening. The axillary lymph node biopsy or cleaning will be performed along the outer edge of the pectoralis major muscle. (5) The vertical subcutaneous pedicle flaps will be W-folded, and the flaps on both sides will be pulled to the vertical pedicle to reshape the breast. During this process, the breast and armpit drainage tubes will be indwelled.
15848718|NCT04052893|Procedure|Modified radical mastectomy|The patients will be placed in the supine position. After intravenous anesthesia, the tumor boundary will be marked and the breast will be removed. The vertical subcutaneous pedicle flaps will be W-folded, and the flaps on both sides will be pulled to the vertical pedicle to reshape the breast. During this process, the breast and armpit drainage tubes will be indwelled.
15848719|NCT04052880|Drug|Daratumumab|Daratumumab 1800 mg will be delivered by subcutaneous injection given through a syringe and needle by a manual push over approximately 3 to 5 minutes. Doses will be administered at alternating locations on the abdomen. Daratumumab will be administered weekly during treatment in Cycles 1 to 2, every 2 weeks during cycles 3-6, and every 4 weeks thereafter.
15848720|NCT04052880|Drug|Bortezomib|Subjects will receive 1.3 mg/m2 bortezomib as a subcutaneous infusion on Days 1, 8, and 15 during the 28-day cycles.
15848721|NCT04052880|Drug|Lenalidomide|"In Cycles 1 through 12, lenalidomide will be self-administered at a dose of 15 mg orally each day on Days 1 through 21 of each 28-day cycle.
~For subjects with CrCl 30-60mL/min, lenalidomide will be reduced to 10mg daily, and for subjects with CrCl 15-30 mL/min, lenalidomide will be reduced to 5mg daily.
~In maintenance phase: lenalidomide will be administered at one dose level below Cycles 1-12 dosing ie 10 mg orally daily.
~In maintenance, for subjects with CrCl 30-60 mL/min, lenalidomide will be reduced to 5 mg daily during maintenance treatment, and for subjects with CrCl 15-30 mL/min, lenalidomide will be reduced to 5 mg every other day during maintenance treatment."
15848752|NCT04052646|Other|Medical condition: Subarachnoid hemorrhage|We identify patients with the condition of interest and retrospectively collect data on them.
15848753|NCT04052633|Radiation|intraoperative cholangiography|success or failure of cholangiography
15849215|NCT04049110|Drug|Placebo|Placebo 1 tablet per 24 hours, oral, for 7 consecutive days
15848722|NCT04052880|Drug|Dexamethasone|"Dexamethasone will be self-administered orally at a total dose of 20 mg weekly during cycles.
~However, the dexamethasone 20 mg oral or IV (only if oral is not available) dose administered as a preinfusion medication on daratumumab infusion days replaces the oral dexamethasone dose for that day. Dexamethasone will be administered until the subject experiences disease progression or unacceptable toxicity.
~In the maintenance phase, dexamethasone/steroid premedications may be tapered or discontinued in the absence of daratumumab related infusion reactions/based on patient tolerance. In the event of persistent daratumumab related infusion reactions, the least amount of steroid premedications needed to prevent the same may be used."
15848723|NCT04052880|Drug|Ixazomib|During maintenance treatment, if choice of maintenance therapy includes ixazomib, ixazomib will be administered at 3 mg orally daily on Days 1,8, and 15 of each cycle. For subjects with CrCl 15-30 mL/min, ixazomib will be reduced to 2.3 mg once per week during maintenance treatment.
15848724|NCT04052867|Drug|Lignocaine|Slow bolus of lignocaine is given over 15 min before the start of surgery, followed by infusion of lignocaine
15848725|NCT04052867|Drug|Normal saline|An equivalent volume of normal saline is given
15848726|NCT04052854|Drug|Zanubrutinib|Zanubrutinib will be orally administered in participants with treatment naive or R/R WM
15848727|NCT04052841|Procedure|Thermal pulsation|Lipiflow (TearScience®, Inc. Morrisville, USA): the lipiflow thermal pulsation system consists of a console and a single-use sterile device, known as the Activator, and has a drug-free mechanism of action. Eye care professionals use the Lipiflow System to treat MGD patients in-office with confidence and efficiency.
15848728|NCT04052841|Procedure|Intense pulsed light therapy|Intense pulsed light (IPL) devices employ high intensity pulses of polychromatic lights with a broad range of wavelength (515-1200 nm). IPL treatment has been utilized for years in the field of dermatology, and then its use was applied to ophthalmology for the treatment of MGD.
15848729|NCT04052841|Procedure|Manual meibomian gland expression|Using an eyelid massaging devices -Eyepeace (Eye Comfort Ltd, Belfast, UK)) for lid massage. The Eyepeace was placed on closed eyelids and gently squeeze and release between 5-10 times daily.
15848730|NCT04052828|Device|FETO with Goldballoon Detachable Balloon (GOLDBAL2) along with the Delivery Microcatheter (BALTACCI-BDPE100)|This will take place between gestation of 27w0d - 29w6d. The balloon will be removed at approximately 34 weeks gestation.
15848731|NCT04052815|Behavioral|Diabetes prevention program culturally tailored|Diabetes prevention Program (DPP) as specified by the CDC, physical activity prior to DPP sessions, motivational interviewing individual and in group. Culturally tailored nutrition tips and recipes.
15848732|NCT04052802|Other|Fissure sealing|The materials will be applied to the demineralized fissures as stated in manufacturer's instructions
15848733|NCT04052789|Other|BioHPP PEEK copings veneered with composite resin|In the first visit, a Face-to-Face adherence session will be held in which the patient should be informed about the study steps and how to maintain oral hygiene measures. Further sessions will occur at the follow-up visits . Participant patients will be asked about any problems they are having. Patients will be recalled every two months for one year for follow up visits.
15848734|NCT04052776|Drug|Buspirone|40mg
15848735|NCT04052776|Drug|Levodopa-Carbidopa|400mg/100mg
15848736|NCT04052776|Drug|Buspirone + Levodopa-Carbidopa|40mg + 400mg/100mg
15848737|NCT04052776|Drug|Placebo oral tablet|Non-active metabolite
15848738|NCT04052763|Diagnostic Test|FFR-CT|FFR-CT is a non invasive method using coronary CT images and 3 dimensional modelling to reconstruct coronary arteries and their stenoses, with subsequent calculation of fractional flow reserve (FFR) based on a mathematical algorithm.
15848739|NCT04052763|Diagnostic Test|FFRangio™|Angiography-derived FFR (FFRangio™) uses coronary angiography images and a mathematical algorithm to reconstruct a 3 dimensional model of coronary arteries with calculation of FFR without the use of a pressure guide.
15848740|NCT04052750|Behavioral|SMS follow-up|In addition to conventional treatment, the experimental group received SMS reminding every day until the end of the treatment.
15848741|NCT04052737|Drug|Normal Saline along with standard treatment|PMZ-1620 (sovateltide) is an endothelin-B receptor agonist. PMZ-1620 has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in Alzheimer's disease patients. In this arm normal saline along with standard treatment will be given for active comparison.
15848742|NCT04052737|Drug|PMZ-1620 (sovateltide) along with standard treatment|PMZ-1620 (sovateltide) is an endothelin-B receptor agonist. PMZ-1620 has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in Alzheimer's disease patients.
15848743|NCT04052724|Behavioral|Intervention group LINGI|Intervention based on cognitive behavioural therapy principles and culturally adapted to Lithuanian population. Intervention's main purpose is to reduce caregiver burden and increase quality of life. Intervention contains psycho-educational elements as well as examples and exercises.
15848744|NCT04052711|Drug|FMX-101|
15848745|NCT04052698|Drug|Wilate|"Produced from the plasma of human donors, Wilate is presented as a powder or solvent for intravenous injection containing normally 500 IU or 1000 IU human VWF and human FVIII per vial. The ratio between VWF ristocetin co-factor activity (VWF:RCo) and FVIII:C is 1:1. The product contains approximately 100 IU/ml human VWF when reconstituted with 5ml/10mL water for injection with 0.1% polysorbate 80.
~The specific activity of Wilate is ≥67 IU VWF:RCo/mg protein. The injection or infusion rate should not exceed 2-3mL per minute."
15848746|NCT04052685|Procedure|Selective removal to soft dentin (SRSD)|In order to prevent pulp exposure in deep caries lesions radiographically extending at least 3/4 of dentin, periphery of the cavity prepared to hard dentin while reasonable amount of soft carious tissue over the pulp is left. This caries removal strategy is termed selective removal to soft dentine.
15848747|NCT04052685|Procedure|Selective removal to firm dentine (SRFD)|Carious tissue is totally removed until hard dentin dry in appearance and hard on probing. This carious removal strategy is strongly recommended for shallow or moderately deep carious lesions.
15848748|NCT04052672|Other|Exercise and Nutritional Supplement|The intervention consists of exercise (a combination of supervised and in home) as well as a nutritional supplement (a combination of whey protein and creatine).
15848749|NCT04052659|Drug|Sintilimab|200 mg IV, every 3 weeks, d1
15848750|NCT04052659|Drug|Chidamide|30 mg PO, 2 times every week, d1 and d4
15848751|NCT04052659|Drug|Azacidine|100 mg SC, every 3 weeks, d1 to d7
15848754|NCT04052620|Drug|Diclofenac diethylamine 2.32% gel|Participants will apply DDEA 2.32% gel topically with the finger tips (for approximately 1 minute) on both sides of affected ankle 5 cm on 200 cm^2 two times daily for 7 days.
15848755|NCT04052620|Drug|Diclofenac diethylamine 1.16% gel|Participants will apply DDEA 1.16 % gel topically with the finger tips (for approximately 1 minute) on both sides of affected ankle 5 cm on 200 cm^2 four times daily for 7 days.
15848756|NCT04052620|Other|Placebo|Participants will apply Placebo gel topically with the finger tips (for approximately 1 minute) on both sides of affected ankle 5 cm on 200 cm^2 two times daily for 7 days.
15848757|NCT04052607|Drug|LH Suppression|Stimulation protocols
15848758|NCT04052594|Drug|LY3475766 - IV|Administered IV
15848759|NCT04052594|Drug|LY3475766 - SC|Administered SC
15848760|NCT04052594|Drug|Placebo - IV|Administered IV
15848761|NCT04052594|Drug|Placebo - SC|Administered SC
15848762|NCT04052581|Procedure|POEM-TIF|Transoral Incisionless Fundoplication (TIF) following Per oral Endoscopic Myotomy (POEM) in the same session
15848764|NCT04052555|Drug|Berzosertib|Given IV
15848765|NCT04052555|Other|Quality-of-Life Assessment|Ancillary studies
15848766|NCT04052555|Other|Questionnaire Administration|Ancillary studies
15848767|NCT04052555|Radiation|Radiation Therapy|Undergo RT
15848768|NCT04052542|Behavioral|Traditional online continuing education|30-minute, online, interactive, educational video describing the benefits of preventive post-extubation NIV, the indications and contraindications for preventive post-extubation NIV, and the value of working together as an interprofessional ICU team when implementing preventive post-extubation NIV
15848769|NCT04052542|Behavioral|Interprofessional education|One-time, 90-120-minute, in-person, interprofessional educational workshop consisting of a 30-minute didactic session and a 60-90-minute small group session
15848770|NCT04052542|Behavioral|Just-in-time education|"Just-in-time, point-of-care education provided by trained advanced practice providers who will be on-hand in the study ICU, where they will deliver the education at the bedside during rounds when a patient meets criteria for preventive post-extubation NIV"
15848771|NCT04052529|Other|Dietary self-monitoring|Participants use a popular smartphone application to track their food and drink intake for one month.
15848772|NCT04052516|Drug|Icosabutate|Icosabutate oral capsule once daily
15848773|NCT04052516|Drug|Placebo|Matching placebo oral capsule
15848774|NCT04052503|Behavioral|Knowledge Broker|Tailored knowledge translation intervention that included barrier assessment and intervention mapping using the theoretical domains framework and participant engagement either fully or partially supported by the knowledge broker.
15848775|NCT04052490|Other|Abutment with flat occlusal reduction with feather edge finish|Non vital teeth require a full coverage restoration to withstand the functional stresses and prevent any further destruction of tooth/crown complex. The zirconia all-ceramic crowns yield a high flexure strength and are used as an esthetic alternative to ceramo-metallic crowns. Several studies linked the effect of preparation designs to the survival of the restoration. Others, studied the effect of the finish line geometries as deep chamfer and shoulder on the marginal integrity of restorations. The feather edge finish line is used with zirconia crowns with limited data regarding its success. However, there is no presented research dealing with the effect of finishing line designs in combination with different occlusal reduction schemes on the marginal fit of full contour zirconia crowns.
15848776|NCT04052464|Other|endometrium biopsy|All patients will have endometrium biopsy.
15848777|NCT04052464|Other|endometrium lavage|In some selected cases biopsy is preceded by endometrium lavage.
15848778|NCT04052464|Other|repeated endometrium lavage|Endometrium lavage is repeated during the same cycle.
15848779|NCT04052451|Biological|MET-2|Subjects will take study medication once daily for the duration of the study
15848780|NCT04052438|Diagnostic Test|HLA-C and KIR determination for patients, couples, oocyte or semen donors, abortive tissue and newborn.|
15848781|NCT04052425|Drug|Ruxolitinib cream|Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
15848782|NCT04052425|Drug|Vehicle|Vehicle cream is a topical formulation applied as a thin film to affected areas.
15848783|NCT04052412|Drug|18F-AraG|All arms of the study will receive an injection of 18F-AraG while on the PET imaging system. Following a 6 minute scan over the heart to acquire input function data, the patient will undergo a 1 hour multi-pass whole-body dynamic PET/CT acquisition to gather whole-body biodistribution data.
15848784|NCT04052399|Device|anodal transcranial direct current stimulation|"Anodal tDCS of the lateral hypothalamus-cognitive or medial hypothalamus-cognitive network.
~The total injected current will never go beyond 4 milliamp, which will be split among the different stimulation electrodes."
15848785|NCT04052399|Device|cathodal transcranial direct current stimulation|"Cathodal tDCS of the lateral hypothalamus-cognitive or medial hypothalamus-cognitive network.
~The total injected current will never go beyond 4 milliamp, which will be split among the different stimulation electrodes."
15848786|NCT04052399|Device|transcranial direct current stimulation|Single blind sham stimulation (ramp-up ramp-down stimulation will be applied for 30 seconds)
15848787|NCT04052386|Behavioral|BASICCS|Participants randomized to the BASICCS condition received a personalized feedback intervention conducted through a web-conferencing platform. The personalized feedback intervention included tailored feedback on drinking quantity and frequency of alcohol, BAC, alcohol-related consequences, normative perceptions of peer drinking, alcohol outcome expectancies, family history of risk, and financial costs of alcohol. They also received up to 24 text messages with protective behavioral strategies for drinking during the following month.
15848788|NCT04052373|Procedure|Implantoplasty|Implantoplasty is the mechanical smoothening of rough titanium implants as part of the surgical treatment of peri-implantitis. Treatment is thought to facilitate self-performed oral hygiene.
15848789|NCT04052373|Procedure|Open flap debridement alone|Open flap debridement alone
15848790|NCT04052360|Drug|Cenerimod|A single oral dose of 4 mg cenerimod will be administered as a film-coated tablet in the morning of Day 1 under fasted conditions.
15849216|NCT04049097|Drug|Arimoclomol|1200 mg/day arimoclomol citrate (400 mg t.i.d.)
15848791|NCT04052360|Drug|Matching Placebo|A single oral dose of matching placebo will be administered as a film-coated tablet in the morning of Day 1 under fasted conditions.
15848792|NCT04052347|Behavioral|Shared decision-making with a Decision-aid|A tablet computer-based decision-aid was developed by the study investigators based on the standards of the International Patient Decision Aid Standards Collaboration9
15848793|NCT04052347|Behavioral|routine shared decision-making|control group
15848794|NCT04052334|Drug|TIL|Participants will receive an infusion of Tumor-infiltrating lymphocytes (TIL) after tumor resection and TIL product is generated.
15848795|NCT04052334|Drug|Interleukin-2|Participants will receive Interleukin-2 (IL-2) 600 000 IU/kg intravenously (IV) bolus (about 15 minutes) every 8 to 16 hours for up to 15 doses, beginning approximately 8 to 16 hours after T-cell infusion.
15848796|NCT04052334|Drug|Fludarabine|Participants will receive an intravenously (IV) infusion of Fludarabine 25 mg/m2 for approximately 30 minutes for 5 days, prior to T-Cell infusion
15848797|NCT04052334|Drug|Cyclophosphamide|Participants will receive Cyclophosphamide 60 mg/kg/day intravenously (IV) in 250 mL normal saline (NS) over approximately 2 hours, 7 days prior to T-Cell infusion
15848798|NCT04052321|Other|3D optical surface scan|A 3D optical surface scan is acquired utilizing a handheld 3D scanner. Such a scanner is comparable to an ordinary photo camera, however, it also records depth.
15848799|NCT04052308|Behavioral|ABPM|Ambulatory Blood Pressure Monitoring at Baseline and at the end of the study
15848800|NCT04052308|Behavioral|The arterial stiffness and endothelial reactivity|The arterial stiffness and endothelial reactivity will be assessed at baseline and at the end of the study
15848801|NCT04052308|Behavioral|Euroqol EQ-5D-5L|Answer Euroqol EQ-5D-5L at baseline and at the end of the study
15848802|NCT04052308|Behavioral|Lectures about knee OA|Patients will participate in two days of lectures two-months apart on the subject of knee OA, but will also come to the hospital at months 1, 3 and 5 after the first class to consult about nutritional habits to be improved; at months 4 and 6 to participate in a group therapy session with the psychologists, 7 sessions with the physical therapy team followed by 7 sessions with the physical educators team (once a week/4 weeks and once every two weeks, three times).
15848803|NCT04052308|Behavioral|Continuous intensity exercise|40 min of treadmill physical exercise (40 min on treadmill at 60% of reserve heart rate.)
15848804|NCT04052308|Behavioral|Exercises with varying intensity and interval|40 min of treadmill physical exercise ( 40 min on treadmill with alternating intensity between 50% (2 min) and 80% (1 min) of HR, resulting in an average load of 60% ((50% 2) + 80% / 3)), 20 min of sub-maximal strength training and 10 min of cooling exercises.
15848805|NCT04052295|Procedure|surgical diaphragmatic plication|The plication was done by the same surgeon either via a 7-8 cm long lateral thoracotomy and entrance to the pleural cavity through the eighth intercostals space on the affected side or using VATS (video-assisted thoracoscopic surgery) procedure. It was performed under single lumen intubation general anaesthesia. The diaphragm with the abdominal content was pushed caudally till the normal position of the copula achieved. At this position a fold of about 5 cm is made using traction forceps of the reluctant diaphragm. Polypropylene sutures (zero or 1) were used to perform the plication of the diaphragm. in making a fold on itself. The plication was performed using interrupted polypropylene U-stitches; usually, it started from posterior part to the anterior part of the diaphragm. We merged every two rows with continuous polypropylene sutures. The diaphragm became tough and firm and returned to its normal position. An intercostal tube was inserted, and the thoracotomy was closed in layers.
15848806|NCT04052282|Device|Mobile Health App|There is no intervention
15848807|NCT04052269|Drug|Sildenafil 100mg|study drug (Sildenafil or Tadalafil) administered orally in pill form with glass of water.
15848808|NCT04052256|Diagnostic Test|Coronary computed tomography angiography|Computational fluid dynamic model information derived from CT
15848809|NCT04052243|Diagnostic Test|Invasive exercise testing|Invasive hemodynamic exercise testing
15848810|NCT04052230|Other|ultrasound measure|Admission to the intensive care unit, and setting up an ECMO Daily monitoring from D1 to D7, follow up at D60
15848811|NCT04052217|Device|Penile Ring|Penile Ring at base of penis
15848812|NCT04052204|Drug|avelumab|Investigational fully human anti-PD-L1 monoclonal antibody
15848813|NCT04052204|Drug|Bempegaldesleukin|Investigational CD122-biased cytokine agonist
15848814|NCT04052204|Drug|talazoparib|poly (adenosine diphosphate [ADP] ribose) polymerase (PARP) inhibitor
15848815|NCT04052204|Drug|enzalutamide|androgen receptor inhibitor
15848816|NCT04052191|Biological|MCRcI® stem cells|Intra-Coronary Administration of MCRcI® stem cells
15848817|NCT04052178|Device|rTMS active and sham|Repetitive transcranial magnetic stimulation of the pharyngeal sensory cortex.
15848818|NCT04052178|Device|PES active and sham|Intrapharyngeal electrical stimulation with a catheter delivering electrical pulses.
15848819|NCT04052178|Dietary Supplement|Capsaicin active and placebo|Capsaicin solution (TRPV1 agonist) at a concentration of 10-5M or placebo solution.
15848820|NCT04052165|Procedure|Glaucoma Implant|
15848821|NCT04052152|Drug|Anlotinib and Sintilimab injection|Patients will be treated with Anlotinib and Sintilimab injection
15848822|NCT04052139|Drug|Low-dose naltrexone|4.5 mg of low dose naltrexone taken once daily for 8 weeks. In week 1, participants will take 4.5mg of naltrexone once daily. In week 2, participants will take 4.5mg of naltrexone once daily, and a placebo capsule twice daily. In weeks 3 through 7, participants will take 1 placebo capsule with 4.5 mg mg of naltrexone once daily, and 2 placebo capsules twice daily. In week 8, in days 1-4 participants will take 4.5 mg of naltrexone with a placebo capsule once daily and 2 placebo capsules twice daily; in days 5-7, participants will take 4.5 mg of naltrexone once daily, and a placebo capsule twice daily.
15848823|NCT04052139|Drug|Gabapentin|Dose will begin at 300 mg daily (300 mg qd), in week 2 the dose will be titrated up to 900 mg daily (300 mg tid). In week 3, the dose will be titrated to 1800 mg daily ( 2 capsules of 300 mg tid) and participants will remain on that dose until week 8. In week 8, in days 1-4 participants will take 1800 mg daily (300 mg+300 mg tid); in days 5-7, participants will take 900 mg daily (300 mg of gabapentin three times daily).
15848845|NCT04051866|Other|Oral hygiene instructions|Education for individual health regarding peridontal disease and its association with diabetes, as well as oral hygiene instructions that include the modified Bass technique, use of interproximal brushes and dental floss
15848824|NCT04052139|Drug|Placebo|In week 1, participants will take 1 placebo capsule once daily. In week 2, participants will take 1 placebo capsule three times per day. In weeks 3 through 7, 2 placebo capsules three times per day. In week 8, in days 1-4 participants will take 2 placebo capsules three times per day; in days 5-7, participants will take 1 placebo capsule three times per day. The placebo medications will be composed of lactose and will not contain active ingredients.
15848825|NCT04052126|Other|Individualized physical activity program|"Participants who agreed to participate in the study will participate in an individualized 6-month physical activity (PA) program, consisting of 3 periods: initiation (1st month), transition (2nd-3rd months) and autonomy (4th-6th months). It is based on 4 PA modalities:
~The supervised PA session in a sterile room or at home once a week during the initiation and transition phases (20-45 min, low-to-moderate intensity, walking, muscle strengthening, balance and flexibility exercises).
~The unsupervised PA session in a sterile room or at home once a week during the transition phase and twice a week during the autonomy phase (same as supervised session).
~Follow-up by telephone once a month during the autonomy phase (30 min, support to PA).
~Continuously wearing an activity tracker throughout the entire program (promotion of walking).
~Activities are planned over a period of 6 months to achieve an intervention that meets the key principles of progression, specificity and empowerment."
15848826|NCT04052100|Other|Usual care|The standard preoperative measures will consist of a recommendation for physical activity and advice on tobacco smoking cessation and reduction of alcohol intake. In addition, patients who suffer from iron deficient anemia will receive intravenous iron and those at risk of malnutrition (Malnutrition Universal Screening Tool ≥2 (www.bapen.org.uk/pdfs/must/must_full.pdf)) or that require weight control for obesity (IMC≥30) will perform a nutrition intervention by a nutritionist.
15848827|NCT04052100|Other|Multimodal prehabilitation|"The experimental group will also carry out a prehabilitation program consisting in:
~A. A motivational interview to reinforce the patient's motivation and generate a commitment in relation to the objectives of the program.
~B. A physical activity promotion program to increase the number of daily steps of patients, measured by a wristband and a mobile App.
~C. A supervised high-intensity exercise training program. D. An individualized nutritional optimization plan with dietary advice and protein supplementation (if necessary). Educational material and motivational messages will be sent through a mobile App.
~F. Psychological support through weekly Mindfulness sessions (1.5 hours duration). Educational material and motivational messages will be sent through a mobile App.
~E. A smoking cessation program consisting psycho-cognitive therapy combined with pharmacological treatment. Educational material and motivational messages will be sent through a mobile App."
15848828|NCT04052074|Other|Music Therapy|We are aiming to use music therapy, with pre-recorded favoured music, as a complementary treatment in oncological patients in palliative care, as well as on the carer. It will be performed using mp3 players or mobile phones.
15848829|NCT04052074|Other|simulation with therapeutic education|Basic therapeutic education repetition performed to all caregivers and oncological patients in palliative care, through earphones
15848830|NCT04052061|Biological|CD19 t-haNK|CD19 t-haNK Suspension for Infusion
15848831|NCT04052048|Diagnostic Test|Subtraction Normalized Expression of Phagocytes Blood Test|Non-invasive blood based immunogenomic assay that targets RNA sequencing to identify disease and disease aggressiveness
15848832|NCT04052035|Procedure|measuring the size of the follicle at time of follicle aspiration|While for an OPU out of the study the follicles are aspirated without measuring their sizes, now the follicles will be measured before they are aspirated. The measurement of the follicles is a non- invasive measurement: as the OPU is always performed under vaginal echo-guidance, the follicles are visible on the screen connected to the vaginal echo probe. By measuring two dimensions of the follicle, an average follicle diameter is registered for that follicle
15848833|NCT04052009|Other|Conventional gait training|Duration and Intensity: 10 sessions of 45 minutes 3-4 times per week Each intervention is conducted by a local physiotherapist For further details please see the description of arms
15848834|NCT04052009|Other|End-effector based gait training|Duration and Intensity: 10 sessions of 45 minutes 3-4 times per week Each intervention is conducted by a local physiotherapist For further details please see the description of arms
15848835|NCT04052009|Other|combined training (conventional and end-effector-based)|Duration and Intensity: 10 sessions of 45 minutes 3-4 times per week Each intervention is conducted by a local physiotherapist For further details please see the description of arms
15848836|NCT04051996|Drug|Glasdegib|Glasdegib will be administered at the starting dose of 100 mg orally once daily.
15848837|NCT04051996|Drug|Decitabine|Decitabine will be administered per local label and will be administered by IV infusion at a dose of 20 mg/m2/day for either 5 days or 10 days as determined by randomization. Each cycle will be every 28 days.
15848838|NCT04051970|Drug|Antiretroviral|"Antiretroviral treatments (ART) will be allocated through central randomization (1:1:) according to the following two strategies:
~Tritherapy-Bitherapy (TRI-BI) strategy:
~TRI between D0 and W16: 3-drug combination (3-DR) including 2 NRTI (either TDF or TAF+XTC) and a once daily integrase inhibitor (Stribild® or Genvoya® or Biktarvy®) or TDF/XTC Gé + Tivicay® or TDF/XTC Gé + Isentress® QD 1200 mg when available) during 16 weeks BI between W16 and W96: if pVL viral load <500 cp/mL at W4 and <50 cp/mL at W12, participants will start the 2-DR regimen TDF or TAF / XTC (TDF/XTC Gé or Descovy®) at W16, until W96.
~(Descovy® : provided that it is available in France), (XTC = FTC or 3TC)
~Immediate Bitherapy (BI) strategy Dolutegravir (DTG, Tivicay® 50 mg QD) plus lamivudine (3TC, 300 mg QD) between D0 and W96.
~Antiretroviral drugs will be prescribed in the context of standard of care."
15848839|NCT04051957|Drug|Isosorbide Mononitrate|The starting dose will be Isosorbide Mononitrate 60 mg ER daily and after 4 weeks, if tolerated but response is not achieved, the dose will be escalated to Isosorbide Mononitrate 120 mg ER daily (2 tabs of 60 mg ER tablets).
15848840|NCT04051957|Drug|Placebo oral tablet|Placebo will be given daily and will be doubled after 4 weeks of start of therapy.
15848841|NCT04051944|Drug|Rozanolixizumab|Subjects will receive rozanolixizumab in a specified sequence during the treatment period.
15848842|NCT04051918|Behavioral|Piano Training|Cognitive training via music learning
15848843|NCT04051892|Device|FixNip™ NRI|The FixNip™ NRI is an implantable hypodermic, silicone implant specially designed for nipple areola definition
15848844|NCT04051866|Procedure|Non-surgical periodontal treatment: Scaling and root planing (SRP)|Removal of dental plaque and dental calculus from the surface of a tooth, from the surface of a tooth apical to the gingival margin accumulated in periodontal pockets, or from the surface coronal to the gingival margin.
15848846|NCT04051853|Drug|Sorafenib|Patients will receive sorafenib at a starting dose of 200 mg twice daily. In the absence of toxicity dosage will be gradually escalated up to 400 mg BID.
15848847|NCT04051853|Other|Midazolam clearance test|Before start of treatment patients receive a single oral dose of midazolam to phenotype CYP3A4 activity. Blood samples will be taken at several time points to measure sorafenib and midazolam concentrations.
15848848|NCT04051853|Other|CYP cocktail clearance test|In a subgroup of 15 patients (in the Academic Medical Center Amsterdam), this test will be replaced by an oral cocktail of subclinical doses of caffeine, midazolam, omeprazole, warfarin and metoprolol and will be repeated after 4 weeks of treatment to assess the influence of sorafenib on cytochrome P450 (CYP) 1A2, 3A4, 2C19, 2C9 and 2D6 activity, respectively.
15848849|NCT04051840|Drug|ClinOleic (Baxter Healthcare, Deerfield, IL, USA)|ClinOleic group: Patients using ClinOleic or Structolipid-based lipid parenteral nutrition regimen. From day 0 to day 5, the goal of treatment is to deliver 25kcal/kg/day, 1.05g/kg/day amino acids, and 1.1g/kg/day lipid.
15848850|NCT04051827|Drug|Midazolam|Midazolam Oral Solution and Midazolam Intravenous Infusion.
15848851|NCT04051827|Drug|TAK-788|TAK-788 Oral Capsules.
15848852|NCT04051814|Other|Micra Transcatheter Pacemaker System|A miniaturized single chamber pacemaker system that is delivered via catheter through the femoral vein and is implanted directly inside the right ventricle of the heart
15848853|NCT04051801|Drug|Dose Escalation of VU319|dose levels of the cohorts will be increased step wise
15848854|NCT04051801|Drug|Dose Escalation of Placebo|dose levels of the cohorts will be increased step wise
15848855|NCT04051788|Other|Step Aerobics|Alternating step knee-lift sequences; alternating leg up, up, down, down patterns; and step kicks, 120 to 126 foot strikes per minute, 20 to 30 minutes per session s, 3 sessions per week up to 6 weeks,The target intensity for all sessions will set at 50-70% heart rate (HR) reserve.
15848856|NCT04051788|Other|Aerobic exercise (Lower limb Cycling)|Lower Limb Aerobic cycling, 20 to 30 minutes per session, 3 sessions per week up to 6 weeks, The target intensity for all sessions will set at 50-70% heart rate (HR) reserve
15848857|NCT04051762|Device|High flow nasal cannula vs. Nasal continuous positive airway pressure|High flow nasal cannula
15848858|NCT04051749|Procedure|Noncardiac Vascular Surgery|Noncardiac Vascular Surgery
15848859|NCT04051736|Biological|Inactivated Polio Vaccine|Inactivated Polio Vaccine at age of 2,3,4 months old, respectively
15848860|NCT04051723|Drug|The dexamethasone plus ropivacaine|The local infiltration solution containing 0.25mg Dexamethasone and 2mg ropivacaine per milliliter. The total volume is 20 ml. The assigned solution will be injected subcutaneously by surgeons along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigators.
15848861|NCT04051723|Drug|The ropivacaine|The local infiltration solution containing 2mg ropivacaine per milliliter. The total volume is 20 ml. The assigned solution will be injected subcutaneously by surgeons along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigators.
15848862|NCT04051710|Drug|Test Product|Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg
15848863|NCT04051710|Drug|Reference Product|Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg
15848864|NCT04051710|Drug|Placebo|Placebo Product
15848865|NCT04051697|Behavioral|SEA CHANGE intervention|The SEA CHANGE intervention consists of six 2.5 hour facilitated group workshop sessions. The sessions run over six consecutive weeks and are delivered face-to-face by a leader and peer facilitator (HNC survivor). Each session focuses on a specific self-management topic and the development/enhancement of a particular set of skills. There are opportunities for peer learning, skills practice and take-home exercises to consolidate skills development. In delivering the intervention, leaders/facilitators use a standardised approach following a leader's/facilitators' manual and participant toolkit.
15848866|NCT04051684|Procedure|Transverse abdominal plane block|Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.
15848867|NCT04051684|Drug|Ropivacaine|Regional anesthesia team will perform a single shot TAP block with 0.5% ropivacaine 15-20 ml / side under ultrasound guided technique with blunt tipped, 21 gauge needle.
15848868|NCT04051671|Device|Transcranial direct current stimulation|Dual Active/sham tDCS will be applied over the leg motor area (M1) during the first 20 mins of conventional physical therapy. Anodal on affected hemisphere, Cathodal on unaffected hemisphere. Each participant will complete two experiments (active/sham tDCS). The interval between two experiments is at least 2 weeks. The two experiments will be performed in random order for each subject.
15848869|NCT04051658|Device|Transcranial direct current stimulation|tDCS will be applied in 1.5 mA, 20 mins before conventional physical therapy for 5 days. All experiments will be performed in random order for each subject.
15848870|NCT04051645|Device|Breathing through a system with adjustable flow resistance|"The proband will breathe through the adjustable flow resistance within the experiment, to which a standard D-lite Flow sensor will be connected, and the airway pressure, flow, minute consumption, oxygen and carbon dioxide, tidal volume, oxygen saturation of peripheral blood and oxygen and carbon dioxide concentrations in both inspired and expired air will be recorded using the Datex-Ohmeda S/5 Patient Monitor vital signs monitor.
~The proband will breathe through the flow resistors in a randomized order, and pre-defined three-minute pauses will be maintained between measurements with different flow resistance values. Each measurement will take approximately two minutes and will be measured on ten different flow resistances."
15848871|NCT04051632|Device|Medtronic 670G insulin pump|"percent of patients who continue to use Medtronic 670G over time
~impact of 670G on glycemic control: hemoglobin A1c, time in range"
15848872|NCT04051619|Drug|intranasal oxytocin, 40 IU, twice a day for 7 days|Adjunct therapy
15848873|NCT04051606|Drug|Regorafenib|Regorafenib is a monotherapy during the study, oral administration at 160 mg once daily will be administered for 3 weeks on /1 week off.
15848874|NCT04051593|Other|Cervical stabilization exercise|The participants followed instructional videos and performed the cervical stabilization exercise program at home for 20 minutes/day, 3 days/week, for 6 weeks.
15848875|NCT04051580|Drug|Lactated Ringer|Comparison of Lactated Ringer's Solution and PlasmaLyte-A as a Base Solution for Del Nido Cardioplegia
15848876|NCT04051567|Drug|Aspirin 100mg|In LDA group, patients were asked for taking 100mg aspirin per night;
15848877|NCT04051554|Other|Neuromuscular and Proprioceptive Training|Myklebust's training program (floor exercises, mat exercises, and wobble board exercises for 5 weeks)
15848878|NCT04051554|Other|Conventional Training|Running, Sprinting, Agility training and Dynamic stretching for five weeks
15848879|NCT04051541|Other|Agitated saline push|Push of agitated saline to simulate adenosine used for supraventricular tachycardia
15848880|NCT04051528|Procedure|aerobic exercise training|The aerobic exercise will first perform 3 minutes of warm-up followed by 25 minutes of resistive aerobic exercise and then 2 minutes cool-down. During the aerobic exercise the target heart rate will be 40 to 70% of maximal heart rate calculated as (208 - 0.7 age). The exercise intensity will be progressed as the participants improve their performance throughout practice. Vital signs and the Borg Perceived Exertion Scale will be monitored and recorded during exercise for each session.
15848881|NCT04051528|Procedure|computerized cognitive training|The core function of cognitive training will be including attention, recognition, color and shape identification, calculation, visual perception, visuospatial processing and executive function. Participants will perform tasks designed to enhance abovementioned types of cognitive functions. The difficult level of this training program will be adjusted automatically and continuously based on each participant's level of performance. Cognitive training group will use commercialized cognitive based training programs to facilitate several cognitive functions. The core function will be including attention, recognition, color and shape identification, calculation, visual perception, visuospatial processing and executive function. Participants will perform tasks designed to enhance abovementioned types of cognitive functions. The difficult level of this training program will be adjusted automatically and continuously based on each participant's level of performance.
15848882|NCT04051528|Procedure|guiding training|At the first time in guiding training will focus on introducing the Goal-Plan-Do-Check strategy and identifying initial three goals by the Canadian Occupational Performance Measure. At the second time in guiding training will begin with a review of the Goal-Plan-Do-Check and will apply the Goal-Plan-Do-Check to the first initial goal. Participants will review this goal and plan, describe the execution of the plan (do), and evaluate the execution of the plan (check). After each execution of the plan, the participant will rate his performance using the COPM Performance Scale, producing iterative scores for each activity. The remaining session of guiding sessions will repeat this process, review performance of identified activities, and applying the Goal-Plan-Do-Check strategy to improve performance.
15848883|NCT04051515|Other|Intradialysis exercise training|Combined exercise, aerobic and resistance training, implemented by nursing staff
15848884|NCT04051515|Other|Home-based exercise training|Combined exercise, aerobic and resistance training, implemented independently home
15848885|NCT04051502|Drug|Method 1: Indocyanine green dye|Injection 4 mL of ICG dye directly into the fallopian tube (1 or more places is acceptable) only to the side where the adnexal mass is located
15848886|NCT04051502|Drug|Method 2: Indocyanine green dye|"1mL of ICG injected at each of the four sites: only to the side where the adnexal mass is located
~Dorsal side of the IP ligament
~Ventral side of the IP ligament
~Dorsal side of the utero-ovarian ligament
~Ventral side of the utero-ovarian ligament"
15848887|NCT04051502|Drug|Method 3: Indocyanine green dye|Injection of 4mL of ICG dye into the IP ligament pedicle after the adnexal mass has been removed. Only to the side where the adnexal mass is located
15848888|NCT04051489|Other|Mobile health App - Test|"Beta Testing 1: The Beta test 1 will be performed with participants inside the Research Center. The purpose of this phase is to increase usability, acceptability and reliability of the mHealth App in participants with knee osteoarthritis (KOA).
~Beta Testing 2: The Beta test 2 will be performed with patients outside the Research Center, at their houses. The purpose is to focus on the mHealth App remote usability, acceptability, and data collection."
15848889|NCT04051476|Other|3-g footbath|A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C) and 36 g ginger flour (3 g per l), followed by a ten-minute post-intervention rest period.
15848890|NCT04051476|Other|6-g footbath|A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C) and 72 g ginger flour (6 g per l), followed by a ten-minute post-intervention rest period.
15848891|NCT04051476|Other|12-g footbath|A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C) and 144 g ginger flour (12 g per l), followed by a ten-minute post-intervention rest period.
15848892|NCT04051476|Other|Warm water footbath|A ten-minute pre-intervention rest period followed by a 20-minute footbath with 12 l of warm water (40 °C), followed by a ten-minute post-intervention rest period.
15848895|NCT04051437|Procedure|Plasma exchange|During each plasma exchange session 3-4lt (1.2-1.3 times of plasma volume) of plasma will be exchanged with fresh frozen plasma and 5% albumin. Plasma exchange session will be done on an alternate day to a maximum of 5 procedures. PLEX will be discontinued if the patients Shows sustained clinical improvement, Receive liver transplantation, Refuses further PLEX session No improvement in clinical condition Intolerant to PLEX procedure
15848896|NCT04051437|Drug|Standard medical treatment|The consented patients will receive standard medical treatment which includes adequate nutrition (35-45 Kcal/Kg with 1.5gm/Kg protein) diuretics, anti HE measures, appropriate antibiotics for infections,tablet entecavir 0.5 mg once daily for hepatitis B, and steroids for autoimmune hepatitis.
15848897|NCT04051424|Device|ConMed bite block|Investigator will fit ConMed bite block in patient's mouth and bronchoscopist will try to visualize the vocal cords.
15848898|NCT04051424|Device|McKay airway|Investigator will fit McKay airway in patient's mouth and bronchoscopist will try to visualize the vocal cords.
15848899|NCT04051424|Device|Williams Airway|Investigator will fit Williams Airway in patient's mouth and bronchoscopist will try to visualize the vocal cords.
15848900|NCT04051398|Other|transcutaneous nerve electrostimulation (TENS) of acupuncture points|TENS application session over the acupuncture points: Feishu, Zhongfu, Taiyuan and Dingchuan using a frequency of 200Hz and a pulse time of 80 seconds of sufficient intensity to cause a slight sensation of local numbness without muscle fasciculations. The TENS application time will be 30 minutes.
15848932|NCT04051203|Other|Normal Saline|2mL normal saline.
15848901|NCT04051385|Other|non surgical periodontal treatment|SRP under local anaesthesia, in a total of 2 clinical visits. Oral hygiene instructions including the modified Bass technique and an appropriate interdental cleaning device with dental floss and interdental brush.
15848902|NCT04051385|Other|Gingival crevicular fluid and serum collection|GCF with filter paper using the intracrevicular method and serum collection
15848903|NCT04051372|Diagnostic Test|Bronchoscopic Alveolar Lavage|"The diagnostic yield of different diagnostic methods for lung infection and non-infectious diseases under allo-HSCT patients.
~Classic microbiological cultures designed for bacteria, fungi, and mycobacteria.
~Detection of human cytomegalovirus (CMV) and EB virus in serum and BAL was tested using a Real-time PCR kit.
~Detection of aspergillus galactomannan antigen 1,3-beta-D-glucan in serum and BAL was performed using an enzyme immunoassay method.
~Cytological and pathogenic microscopic evaluation in BALF
~Flow cytological analysis of T lymphocyte subsets in BALF and serum
~Cytokine detection in BALF and serum
~Microbiology detection in BALF by mNGS"
15848904|NCT04051359|Other|Low carbohydrate (130 g) diet|Isocaloric moderately reduced carbohydrate diet (RCD, reduced carbohydrate diet) (~130 grams of carbohydrates)
15848905|NCT04051346|Dietary Supplement|Low Oxalate Diet|Participants will consume a diet that is controlled in its daily contents of oxalate and calcium, and in its content of carbohydrate, fat, and protein. Participants will be asked not to take any dietary supplements, to exercise strenuously, or to consume food or drink that is not provided to them
15848906|NCT04051346|Dietary Supplement|High Oxalate Diet|Participants will consume a diet that is controlled in its daily contents of oxalate and calcium, and in its content of carbohydrate, fat, and protein. Participants will be asked not to take any dietary supplements, to exercise strenuously, or to consume food or drink that is not provided to them.
15848907|NCT04051333|Device|ALS Nutrition App (MyDataHelps platform)|We have designed a mobile health app to provide nutritional counseling and to measure disease outcomes both through self-reported questionnaires and through passive data collection.
15848908|NCT04051320|Drug|Leuprolide Acetate 3.75 MG/ML|3.75 mg/month leuprolide acetate intramuscular injection
15848909|NCT04051320|Drug|Estradiol 2 Mg tablet|2 mg estradiol tablet
15848910|NCT04051320|Drug|Micronized progesterone|200 mg micronized progesterone tablets
15848911|NCT04051307|Drug|PD-L1 peptide: PD-L1 Long(19-27) Peptide sequence: FMTYWHLLNAFTVTVPKDL|Peptide vaccination
15848912|NCT04051307|Drug|Arginase1 peptide: ArgLong2(169-206) Peptide sequence ISAKDIVYIGLRDVDPGEHYILKTLGIKYFSMTEVDRL|Peptide vaccination
15848913|NCT04051294|Dietary Supplement|Commercial kombucha tea|Commercially-available kombucha tea.
15848914|NCT04051294|Dietary Supplement|Brewed kombucha tea|Kombucha tea brewed
15848915|NCT04051294|Other|Control: Tea|Tea brewed in our lab.
15848916|NCT04051294|Other|Control: Water|Tap water
15848917|NCT04051281|Behavioral|Letter|Letters sent to GPs in relevant practices (prescribing data is by practice, so the practice is the unit of randomization)
15848918|NCT04051268|Biological|Vi-DT Typhoid Conjugate Vaccine|1 dose of Investigational Product
15848919|NCT04051268|Biological|PQed Typhoid Conjugate Vaccine|1 dose of Active Comparator
15848920|NCT04051268|Biological|Vi Polysaccharide Vaccine|1 dose of Active Comparator
15848921|NCT04051255|Drug|full mouth ultrassonic debridement associated to Amoxicilin 500 + Metronidazole 400 mg|The patients were treated by a single-session of periodontal debridement under local anaesthesia during 45 minutes, using an ultrasonic instrument#, using subgengival tips* and irrigation with sterile saline solution, by the same operator (MGC, Paulista University, São Paulo, Brazil). After the debridement, all patients was prescribed with Amoxicillin 500 mg and Metronidazole 400 mg, every 8 hours, for 10 days (Casarin et al., 2012). Subjects were extensively informed about the intake of the prescribed medication. Subjects were clinically and microbiologically monitored at baseline (before therapy) and at 3 and 6 months post-therapy. During the monitored sessions, oral hygiene was evaluated and home care instructions were re-emphasized. Additionally, all subjects were recalled monthly for oral hygiene instructions.
15848922|NCT04051242|Device|XenMatrix™ AB Surgical Graft|Graft implantation, radiographic, functional, and electrophysotherapy outcomes will be measured at various time points up to 24-28 weeks post-operatively. A CT scan or MRI will be collected at screening and pre-operative visits to evaluate tissue volume, then again at post-operative Visit 1 and Visit 6. Physical therapy training will be performed as a research procedure following Graft implantation for a maximum of 30 weeks. Additionally, Physical Therapy evaluations will be conducted at screening, pre-op visit 1, post-op, and at post-op Visits 3, and 4. A small core needle biopsy 1-5 grams will be collected at three time points to conduct histomorphological assessment of the tissue prior to Graft implantation (Operative visit, Visit 2 and at Visit 4).
15848925|NCT04051216|Behavioral|Education information system|Participants will receive a mobile tablet as an educational intervention
15848926|NCT04051216|Other|Activity monitor|Participants will receive at least 1 of 4 activity monitoring devices
15848927|NCT04051216|Other|Interview|Participants will be interviewed about their experience using the device(s)
15848928|NCT04051216|Other|Survey Administration|Participants will receive surveys
15848929|NCT04051216|Other|Laboratory Biomarker Analysis|Correlative studies
15848930|NCT04051203|Biological|Autologous Platelet Rich Plasma Injection|60mL of blood will be drawn from the antecubital vein and processed via centrifugation. Samples will be centrifuged as per manufacturer instructions, yielding 5mL of PRP. For quality testing, 1mL of PRP will be sent to the lab for analysis of platelet and leukocyte count, as compared to the patients' whole blood.
15848931|NCT04051203|Drug|Depo-Medrol and lidocaine|Steroid injections will be prepared to include 20mg Depo-Medrol and 2mL 2% lidocaine.
15848933|NCT04051190|Dietary Supplement|VLED group|10-week weight loss period with total meal replacement, consisting of 750 kcal/day. Measurements will be taken at baseline (before diet start), 10 weeks after intervention start (Wk11), and at 1 year.
15848934|NCT04051190|Procedure|Sleeve Gastrectomy group|Standard clinical practice with 2-week diet consisting of 750 kcal/day prior to surgery. The pre- and post-surgical diet of this group will be matched with the VLED group in macro- and micronutrient composition. Measurements will be taken at baseline (before diet start), 10 weeks after intervention start (Wk11), and 1 year after surgery (sleeve gastrectomy)
15848935|NCT04051190|Procedure|Gastric Bypass group|Standard clinical practice with 2-week diet consisting of 750 kcal/day prior to surgery. The pre- and post-surgical diet of this group will be matched with the VLED group in macro- and micronutrient composition. Measurements will be taken at baseline (before diet start), 10 weeks after intervention start (Wk11), and 1 year after surgery (gastric bypass)
15848936|NCT04051177|Behavioral|"Interactive Communication with Openness, Passion, and Empowerment ICOPE"|"The parent curriculum consists of five interactive training sessions (120 minutes each session for 10 hours total) with three specific focuses: understanding the stages of childhood cognitive development in the context of parental illness (Session #1 Child's readiness for disclosure); improving the parents' cognitive and behavioral skills related to parental HIV disclosure (Session #2 Benefits and risks of disclosure, Session #3 How to tell and what to tell, and Session #4 Disclosure is an ongoing process); and improving parental psychosocial well-being in adapting to living with HIV/AIDS (Session #5 Cope with my infection/illness). The curriculum addresses the issues of child and family strengths and community support across sessions."
15848937|NCT04051177|Behavioral|Nutrition Curriculum|"The modified curriculum consists of five 2-hour interactive training sessions with aims to increase parents' knowledge of nutrition (Session #1: Food variety; Session #2: Food for growing child), healthy diets and cooking practice (Session 3: Fat, salt and sugar; Session 4: Fruits, vegetables and minerals), and food safety (Session #5 Food safety)"
15848938|NCT04051164|Other|Progressive Muscle Relaxation Technique|"PMRT begins by assuming a comfortable position of lying down, sitting or leaning back.
~Patient is asked to take a breathe in and intentionally contract muscle and hold muscle and after that release all tension and focus on sensation of relaxation. Each muscle group is tensed for 5-7 seconds and relaxed for 20-30 seconds. PMRT is given twice a day for one week."
15848939|NCT04051164|Other|Conventional treatment|Strengthening exercises of residual limb: After amputation strengthening exercises of residual limb is necessary to prevent shortening of muscles and tightening of joints, moreover it is necessary to make residual limb strong and flexible in order to use a prosthesis. This include Hip abduction, prone hip extension and Prone position. Gait training: This include standing exercises in the parallel bars with or without the prosthesis. Initial walking exercises in which the patient is taught to raise each knee alternately and to try to take weight on his limb as much as possible. Deep Breathing exercise: Deep breathing 10-15 repetitions twice a day.
15848940|NCT04051151|Behavioral|Gameficiation|Participants and partners that have randomized to the gamification group will receive instructions and help in setting up a game platform via Way to Health. This game will include wearing a Fit Bit device, setting a daily step goal, and point deductions for failure to meet this step goal throughout the following 4 weeks. Participants will move up or down specified levels each week depending on how many days they met their step goal.
15848941|NCT04051138|Other|Voxx socks and sleeves|participants will be tested with a true device as well as with a placebo device
15848942|NCT04051112|Drug|SCB-313|10mg group: Intraperitoneal injection single dose on Day 0, safety observation for 7 days, then 3 continuous doses on Day7, Day8, Day9, 21 days for 1 cycle
15848943|NCT04051099|Procedure|Bilateral superficial cervical plexus block with 0.25% bupivacaine 8 ml each (total 16 ml)|bilateral superficial cervical plexus
15848944|NCT04051099|Drug|Dexmedetomidine plus propofol infusion|Dexmedetomidine 0.5 ug/kg infusion in 10 min then 0.5 ug/kg/h, Propofol infusion
15848945|NCT04051099|Procedure|Local infiltraion analgesia|local infiltration analgesia with 2%lidocaine with adrenaline 5 ug/ml 10 ml
15848946|NCT04051099|Procedure|General anesthesia with endotracheal tube|Induction with Propofol and intubation with cisatracurium
15848947|NCT04051086|Biological|Physical examination and Urine and blood samples|"Only one visit for each participant : A large majority of visits will be part of patients' usual care
~Medical examination : birth, weight, gender, blood pressure, medical history
~Urine and blood samples"
15848948|NCT04051086|Biological|Urine and blood samples|"Only one visit for each participant
~Medical history
~Urine and blood samples"
15848949|NCT04051073|Device|Continuous non-invasive blood pressure monitoring|Continuous non-invasive blood pressure monitoring using CNAP
15848950|NCT04051047|Drug|Gemcitabine|Participants receive a one time IV dose of gemcitabine prior to having standard of care surgery.
15848951|NCT04051047|Procedure|Tumor biopsy and blood draw|As part of standard of care, all participants will undergo tumor biopsy and collection of peripheral blood.
15848952|NCT04051034|Dietary Supplement|Omega 3|"Active: 1.25 g capsules/420 35-count bottles [1.25 g capsule contains min. 750 mg EPA + 250 mg DHA] and heat therapy, increase internal body temperature 1.2 C above baseline.
~Placebo: 14,700 1.25 g capsules/420 35-count bottles [1.25-gram high oleic safflower oil capsule]"
15848953|NCT04051034|Other|Placebo|Active: 1.25 g capsules [1.25-gram high oleic safflower oil capsule] and heat therapy, increase internal body temperature 1.2 C above baseline.
15848954|NCT04051021|Behavioral|Comfort Coach|A trained comfort coach will provide emotional and psychological interventions at six time points: preoperative clinic, day of surgery, extubation, chest tube removal, discharge, 30-day clinic follow-up, and 90-day post-discharge. Patients will also complete surveys at specific time points (preoperative clinic, hospital discharge, 30-day clinic follow-up, and 90-day post-discharge).
15848955|NCT04051021|Other|Usual Care|Patients will complete surveys at specific time points (preoperative clinic, hospital discharge, 30-day clinic follow-up, and 90-day post-discharge).
15848956|NCT04051008|Behavioral|Online - use of online grocery shopping platform|The Online intervention will utilize online grocery shopping (shopping at a local grocery store via online platform).
15849039|NCT04050241|Device|Mcintosh intubation|Anesthetists will perform intubation in patients undergoing elective neurosurgery with the Mcintosh laryngoscope, while completing a secondary auditory task. Response times to the secondary task will be recorded, and operators will complete the NASA Task Load Index questionnaire at the end of each procedure.
15848957|NCT04051008|Behavioral|Default - use of online grocery shopping platform with default shopping carts|The Defaults intervention, will augment the Online intervention, showing participants a default cart when they log into their online grocery shopping accounts. They will be told that their cart has been filled with items that conform to a diabetic diet and can be used to make the recipes from provided recipe cards, and that they may modify their cart as they like.
15848958|NCT04050982|Device|AF CARE|Patients will receive personalized messages twice weekly that will include behavior recommendations for CVRF reduction and AF education based on the initially entered psychographic profile and data entered.
15848959|NCT04050982|Behavioral|Usual Care|Participants will be given recommendations for CVRF reduction based on their initial LS7 assessment and will be provided educational materials and a wireless scale.
15848960|NCT04050969|Procedure|Bariatric surgery|Participants will undergo either a laparoscopic sleeve gastrectomy or laparoscopic Roux-en-Y gastric bypass.
15848961|NCT04050969|Procedure|Atrial Fibrillation (AF) Catheter Ablation|Participants will undergo catheter ablation using either radiofrequency or cryoablation of pulmonary veins. Participants with persistent AF may also undergo roof and/or floor linear ablation with or without ablation of extrapulmonary sites at the physician's discretion.
15848962|NCT04050943|Other|observational cohort|Recording the clinical, pathophysiology, and psychological parameters, to observe and predict the clinical outcomes of these patients.
15848963|NCT04050930|Other|Mastication|Simultaneous recordings of postprandial thermogenesis (gas exchange), cardiac activity (ECG), masticatory muscle contraction (EMG), and blood collection, during alternating periods of no-mastication or mastication of natural foods or chewing gums of different hardness
15848964|NCT04050917|Device|real stimulation|The smartwatch generates imperceptible vibratory stimulation.
15848965|NCT04050917|Device|no stimulation|The smartwatch generates no stimulation.
15848966|NCT04050904|Device|ExpHeart|ExpHeart is composed of an Information System (web application) and an algorithm, the Expert System, embedded on the Information System. The Information System is a cyber-securised web application and the Expert System uses a proprietary therapeutic algorithm to optimize pharmacological HF treatment. The Expert System is based on the analysis of a continuously updated clinical database integrating the patient's electronic medical record (managed by the Information System). The Expert System will generate prescription recommendations directed to the treating investigator through the Information System.
15848967|NCT04050891|Device|combined supraclavicular and interscalene block|"Supraclavicular block An in plane approach, a 22G needle 75mm was advanced from lateral to medial to the corner pocket where the lower trunk commonly lies at this area between the subclavian artery medially, first rib inferiorly and the plexus superiorly then 10ml of the mixture local anesthetic was injected, the remaining volume was injected just above and lateral to the subclavian artery.
~Interscalene block After local anesthetic infiltration of the skin, a 22G needle 75mm was inserted in plane approach from lateral to medial toward the inter-scalene groove between the anterior and middle scalene muscles. The anesthetic mixture 15 ml was injected toward C5, C6 cervical nerve roots aiming to block nerves escaped from supraclavicular nerve block."
15848968|NCT04050878|Device|Facial scanner (Bellus3D) to assess perioral alterations|Use of a digital caliper for conventional measurements and a facial scanner (Bellus3D) to analyse the modifications induced by the use of implant supported dental prostheses in the lip support
15848969|NCT04050865|Drug|Dexamethasone, 0.4mg|Ophthalmic Insert
15848970|NCT04050865|Device|Placebo plug with no drug|Ophthalmic Insert
15848971|NCT04050852|Drug|Nusinersen Treatments|Antisense oligonucleotide, which targets the SMN2 pre-mRNA, particularly exon 7.
15848972|NCT04050839|Other|Pain neuroscience education|A total of 4 NPE (Neuroscience paine education) sessions were held, once each week in addition medical treatment similar to control group. The NPE sessions were conducted by an experienced physiotherapist certified in NPE in face-to-face, group sessions lasting 40-45 minutes. In NPE, the patient is taught about the physiology of pain, central sensitization, representation of the different body regions in the brain, pain-related changes in body perception, and the psychosocial dimensions of pain.
15848973|NCT04050839|Drug|Medical treatment|The patients in control group continued taking their regular gabapentin and pregabalin-derivative drug therapy at the same dosage and duration specified by their physicians.
15848974|NCT04050826|Drug|Lidocaine 2.5% and Prilocaine 2.5% cream, USP (Actavis Pharma incorporated, USA)|Topical application
15848975|NCT04050826|Drug|Lidocaine 2.5% and Prilocaine 2.5% cream (E. Fougera & Co. a division of Fougera Pharmaceuticals Inc., USA)|Topical application
15848976|NCT04050826|Drug|Oraqix Parodontal-Gel (Dentsply Detrey GmbH, Germany)|Topical application
15848977|NCT04050826|Device|Dermal open flow microperfusion|"Dermal open flow microperfusion will be used to collect interstitial fluid in order to assess lidocaine/prilocaine concentration in the dermis.
~16 dOFM probes will be implanted per participant (8 test-sites; 2 dOFM probes per test-site).
~From each dOFM probe 13 samples will be taken (1 pre-dose, 12 post-dose)."
15848978|NCT04050826|Procedure|Blood sampling|1 sample will be taken pre-dose and 12 samples post-dose.
15848979|NCT04050813|Behavioral|Exercises program for hamstring architecture and function|To assess the effectiveness of the inertial flywheel resistance program in the architecture and function of the hamstrings post structural hamstring injury
15848980|NCT04050800|Drug|Carbon 11 Butanol|Two sequential administrations of a PET tracer
15848981|NCT04050787|Procedure|D2 Lymphadenectomy including No. 10|After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic total gastrectomy with D2 lymphadenectomy including spleen-Preserving No. 10 Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy
15848982|NCT04050787|Procedure|D2 lymphadenectomy excluding No. 10|After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic total gastrectomy with D2 lymphadenectomy excluding spleen-Preserving No. 10 Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy
15849070|NCT04050020|Biological|Normal saline injection|All subjects of this group will receive 2 sessions of normal saline penile injection with 30 +/- 3 day treatment interval for all subjects, 10 ml of normal saline will be injected at each session.
15848983|NCT04050774|Device|Balance boards|The unstable surface will be created with a balance board consisting of a wooden board mounted on a section of a cylinder, creating an unstable support in the sagittal plane or in the frontal plane. The participants will stand on three balance boards, varying the height of the surface of the board above the point of contact (15, 17 and 19 cm respectively). The radius of the cylinder will kept constant at 24 cm. The standing surface will be 48cm x 48 cm
15848984|NCT04050761|Biological|Nivolumab|Specified dose on Specific Days
15848985|NCT04050748|Procedure|Achilles tendon repair|Patients will be undergoing achilles tendon repair
15848986|NCT04050735|Other|Alcohol, ethyl, moderate dose|Moderate oral dose of ethyl alcohol
15848987|NCT04050735|Other|Placebo|Placebo beverage
15848988|NCT04050722|Drug|Sensodyne Repair and Protect|Participants will brush their teeth with Sensodyne Repair and Protect (containing 0.454% stannous fluoride) for 1 timed minute twice a day (morning and evening), for 3 weeks.
15848989|NCT04050722|Drug|Colgate Cavity Protection|Participants will brush their teeth with Colgate Cavity Protection repair and protect (containing sodium fluoride) for 1 timed minute twice a day (morning and evening), for 3 weeks.
15848990|NCT04050709|Biological|PD-L1 t-haNK|PD-L1 t-haNK Suspension for Infusion
15848991|NCT04050696|Device|BQ 1.2|BQ 1.2 exposure of EMF exposure paradigm in conjunction with upper limb PT regimen
15848992|NCT04050683|Procedure|Study - Transjugular Intrahepatic Portosystemic Shunt (TIPS)|Prior to and 1-3 days after the TIPS procedure, the following blood tests are done for research purposes: Brain Natriuretic Peptide (BNP); Endothelin-1; Tumor Necrosis Factor-alpha (TNF-a); Endothelial Nitric Oxide Synthase (eNOS). Subjects with abnormal heart pressures during TIPS will have a right heart catheterization (RHC) to monitor heart function, blood flow, and pressures in and around the heart. The subject will be admitted to the Cardiovascular Intensive Care Unit and have a TTE all of which are standard of care. Routine follow-up visits will occur in IR Clinic at 2 Weeks (± 3 days), 4-6 weeks and 4-6 months. Visits will include: blood draws for research related blood tests as listed above; standard of care ultrasound of the abdomen; TTEs; and for at least one year, routine lab testing, imaging, medications, and subject overall condition will be assessed for long term outcomes. Diagnostic RHC will be done as needed per standard of care.
15848993|NCT04050683|Procedure|Control - Transjugular Intrahepatic Portosystemic Shunt (TIPS)|"Subject's with normal heart pressures who are having elective (planned in advance and not due to an emergency) TIPS due to refractory ascites (fluid build up in the belly that does not go away or comes back shortly after being removed). Prior to and 1-3 days after the TIPS procedure, the following blood tests are done for research purposes: Brain Natriuretic Peptide (BNP); Endothelin-1; Tumor Necrosis Factor-alpha (TNF-a); Endothelial Nitric Oxide Synthase (eNOS). The subject will be admitted to the hospital after TIPS for standard of care monitoring.
~Routine follow-up visits will occur in IR Clinic at 2 Weeks (± 3 days), 4-6 weeks and 4-6 months. Visits will include: blood draws for research related blood tests as listed above; standard of care ultrasound of the abdomen; and for at least one year, routine lab testing, imaging, medications, and subject overall condition will be assessed for long term outcomes. A research related TTE will be done at the 4-6 week visit."
15848994|NCT04050670|Drug|Tirzepatide|Tirzepatide administered SC
15848995|NCT04050657|Other|appointment interval|To change the appointment interval for one group and keep the standard interval for the other group by measuring alignment duration, measured as days needed to align the teeth using full-arch fixed appliances
15848996|NCT04050644|Drug|Preservative Free drop treatment|Patients will use the preservative-free dexamethasone 0.1% 4 times a day in the first week after cataract surgery, 3 times a day in the second week, twice daily in the third week and once daily in the fourth week and diclofenac 0.1% eye drops 3 times daily for 1 day preoperatively and every 15 minutes in the hour before surgery and then 3 times a day for four weeks.
15848997|NCT04050644|Drug|Preserved drop treatment|Patients will use the preserved dexamethasone 0.1% 4 times a day in the first week after cataract surgery, 3 times a day in the second week, twice daily in the third week and once daily in the fourth week and diclofenac 0.1% eye drops 3 times daily for 1 day preoperatively and every 15 minutes in the hour before surgery and then 3 times a day for four weeks.
15848998|NCT04050631|Behavioral|maternal arrest simulation on L&D floor|AFE on L&D
15848999|NCT04050618|Device|fanfilcon A test lens|Silicone hydrogel contact lens
15849000|NCT04050618|Device|ocufilcon D control lens|hydrogel contact lens
15849001|NCT04050618|Device|etafilcon A control lens|hydrogel contact lens
15849002|NCT04050605|Device|somofilcon A toric contact lens|Contact Lens
15849003|NCT04050605|Device|fanfilcon A toric contact lens|Contact Lens
15849004|NCT04050592|Drug|Estradiol|Active intervention is estradiol. Hormone therapy (HT) of all 150 participants will be standardized to 2.0 mg of oral estradiol (E2) without progestogen for six weeks prior to randomization. After that participants will be randomized into three groups (A, B, C) of equal size.
15849005|NCT04050592|Other|Placebo|Those in groups A and B will switch from estradiol to placebo at the beginning of the 10th week after abrupt or tapered discontinuation of HT.
15849006|NCT04050579|Device|on-pump intracardiac echocardiography|Subjects will be patients with hypertrophic cardiomyopathy with interventricular septae less than 2.0cm who are undergoing septal myectomy. The patients will have already had a number of preoperative transthoracic echocardiographs as part of their normal hypertrophic cardiomyopathy care. Before cardiopulmonary bypass, the basal anterior septal thickness will be measured by transesophageal echocardiograph as is performed in all septal myectomy procedures. The Principal Investigator will then use the OPIE probe to measure the anterior basilar septal thickness. Myectomy will be performed and OPIE will be repeated. The post-myectomy anterior basilar septal thickness will again be measured by transesophageal echocardiography.
15849007|NCT04050553|Drug|Tirzepatide|Administered SC
15849008|NCT04050553|Drug|Placebo|Administered SC
15849009|NCT04050540|Drug|Doxycycline|200 mg of doxycycline to be taken orally within 24 hours and up to 72 hours after each condomless sex act
15849071|NCT04050007|Other|Preventive initiation of fluid removal|"Preventive initiation of fluid removal will be started right after the randomization with intravenous diuretics according to a predefined algorithm based on the urine output every three hours.
~The weaning process and post extubation preventive strategy will be protocolized based on the last international guidelines"
15849211|NCT04049136|Diagnostic Test|NT-proBNP|Measure levels of NT-proBNP in healthy pregnancy women across BMI categories.
15849010|NCT04050514|Device|H-MAD with a hinge system according to Herbst|"The randomized grouping into blocks at a ratio of 1: 1 takes place over sealed envelopes containing the allocation key for the respective MAD. The assignment is stratified according to gender because gender is a strong predictor of sleep disorders and also temporomandibular dysfunctions Integration of the MAD (start of treatment) The laboratory-made MAD (F-MAD / H-MAD) is integrated and checked for a comfortable fit. The patient is instructed to always wear the splint during sleep.
~All patients receive an extended guide to jaw gymnastics with the instruction to do it in the morning after waking up and in the evening before falling asleep.
~Four weeks after incorporation, the titration phase begins, the slow adjustment of mandibular advancement to optimize sleep medical parameters while minimizing unwanted side effects.
~Control appointments take place after four weeks, six months, one year and two years after insertion of the MAD"
15849011|NCT04050501|Device|non-invasive Vagus Nerve Stimulator|Two stimulations of two minutes each will be applied in the neck every 15 minutes in the first 3 hours. Thereafter two stimulations will be applied every 8 hours over the next 5 days or until discharge, whichever occurs first. The stimulation side in the neck will be the radiological side of the stroke.
15849012|NCT04050488|Drug|Zinc Sulfate|At the age of 3 days or priming> 20cc / kg body weight/day the research assistant will give a bottle of medicine containing zinc (according to the results of randomization) without knowing the contents either by the doctor or the room nurse.
15849013|NCT04050488|Drug|Placebos|At the age of 3 days or priming> 20cc / kg body weight/day the research assistant will give a bottle of medicine containing placebo (according to the results of randomization) without knowing the contents either by the doctor or the room nurse.
15849014|NCT04050475|Dietary Supplement|Fasting Mimicking Diet|The Fasting Mimicking Diet is a low-calorie, five-day eating program meant to promote weight loss and provide the same benefits as more traditional fasting methods.
15849015|NCT04050462|Drug|Nivolumab 240 mg IV every 2 weeks + Cabiralizumab 4 mg/kg IV every 2 weeks|Nivolumab 240 mg IV plus Cabiralizumab 4 mg/kg IV every 2 weeks combination therapy
15849016|NCT04050462|Drug|Nivolumab 240 mg IV every 2 weeks + BMS-986253 1200 mg IV every 2 weeks|Nivolumab 240 mg IV plus BMS-986253 1200mg IV every 2 weeks
15849017|NCT04050462|Drug|Nivolumab 240 mg IV every 2 weeks|Arm 1 (control) Nivolumab 240mg IV every 2 weeks monotherapy
15849020|NCT04050410|Drug|Moxonidine|active drug given as 1 dose
15849021|NCT04050410|Drug|Placebo|placebo pill given as 1 dose
15849022|NCT04050397|Other|Progressive supervised weight training|12 weeks of progressive weight training twice a week supervised by a qualified physiotherapist.
15849023|NCT04050397|Other|Lecture|Urologist informs participants on adverse effects of castration treatments and benefits of regular exercise. Physiotherapist gives an exercise program to follow at home, and nutritionist informs patients on correct nutrition to assist physical exercise.
15849024|NCT04050384|Device|Baby GentleStick|The Baby GentleStick is a handheld device that fits and provides vibration to an Owen Mumford Unistik3 Dual lancet. The gentle vibration occurs at 178 Hertz with a free-hanging 0.24 mm range of motion. The device may provide vibration alone and also allow for simultaneous vibration and deployment of the lancet.
15849025|NCT04050371|Drug|200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate|All study participants received daily observed therapy with FTC/TDF.
15849026|NCT04050358|Dietary Supplement|NRPT|Subjects randomly assigned to the active group will receive Nicotinamide Riboside and Pterostilbene (each capsule contains 125 mg NR and 25 mg PT, total daily dose is 2 capsules) for 3 weeks
15849027|NCT04050358|Dietary Supplement|Placebo oral capsule|Subjects randomly assigned to the Placebo group will receive placebo oral capsules for 3 weeks
15849028|NCT04050332|Behavioral|Stair Walking|Walking up and down stairs for four minutes at a comfortable pace
15849029|NCT04050319|Diagnostic Test|Screening and diagnosis if injured|physical therapy
15849030|NCT04050293|Drug|SPN-538|Patients will receive SPN-538
15849031|NCT04050293|Drug|Placebo|Patients will receive Placebo
15849032|NCT04050280|Drug|Cladribine, Cytarabine, and Granulocyte-Colony Stimulating Factor with Fractionated Gemtuzumab Ozogamicin (CLAG-GO)|"Induction:
~G-CSF 300 mcg subcutaneously daily on days 0-5.
~Cladribine 5 mg/m2 in normal saline given intravenously over 2 hours daily on days 1-5.
~Cytarabine 2000 mg/m2 in normal saline given intravenously over 4 hours daily on days 1-5.
~Gemtuzumab ozogamicin 3 mg/m2 intravenously over 2 hours on days 1 and 4, prior to cladribine and cytarabine.
~Consolidation:
~If CRMRD-, CR or CRi is confirmed by bone marrow biopsy and aspirate after induction chemotherapy, patients may receive one cycle of consolidation chemotherapy (at the discretion of the investigator) with the same CLAG-GO regimen at the same doses given for induction. In addition, the investigator has the option of giving CLAG alone without GO if there is concern for increased risk of sinusoidal obstruction syndrome.
~Patients who remain in CRMRD-, CR or CRi after consolidation chemotherapy may receive up to eight infusions of GO 2 mg/m2 approximately every 28 days."
15849033|NCT04050267|Drug|Nitrous Oxide|Breathing nitrous oxide, concentrations 5, 7, 10, 12, 15, 20 % in air with 21 % oxygen, in random order.
15849034|NCT04050267|Other|Placebo - air|Breathing air with 21 % oxygen, no nitrous oxide.
15849035|NCT04050254|Device|Real tDCS|Real tDCS (STARTSTIM® 8 stimulator, Neuroelectric Barcelona, Spain) for five sessions on alternate days.tDCS is a galvanic current applied by a cap for 20 minutes at an intensity of 2 milliamps.
15849036|NCT04050254|Device|Sham tDCS|Sham current (STARSTIM® 8 stimulator, Neuroelectric Barcelona, Spain) for five sessions on alternate days. Sham tDCS will be applied for the same time than real tDCS.
15849037|NCT04050254|Device|Therapeutic exercise|The therapeutic exercise program will include aerobic exercise and muscle strengthening for five sessions on alternate days. The program will include exercises and will last 30-45 minutes.
15849038|NCT04050241|Device|Glidescope intubation|Anesthetists will perform intubation in patients undergoing elective neurosurgery with the Glidescope videolaryngoscope, while completing a secondary auditory task. Response times to the secondary task will be recorded, and operators will complete the NASA Task Load Index questionnaire at the end of each procedure.
15849107|NCT04049786|Procedure|Intestinal biopsy|All patients with indication for RYGB bariatric surgery undergo to endoscopy before and after the surgery as standard protocol. Intestinal biopsy are being performed during the surgery, pre- and post-endoscopies.
15849040|NCT04050228|Other|Imaging|Patient in the control arm will receive standard neoadjuvant chemotherapy and clinical monitoring as per standard of care. Patients will be imaged but no modifications to treatment will occur in this trial arm depending on response by quantitative ultrasound. Patients in the experimental arm will receive adaptive neoadjuvant chemotherapy based on quantitative ultrasound monitoring. Non-responders to neoadjuvant chemotherapy based on quantitative ultrasound will be switched to different chemotherapy or other treatments reflecting current clinical practice. The treatment option will be left to the discretion of the treating medical oncologist and the care team.
15849041|NCT04050215|Procedure|Computed Tomography|Undergo PET/CT
15849042|NCT04050215|Drug|Gallium Ga 68-labeled PSMA-11|Given IV
15849043|NCT04050215|Procedure|Positron Emission Tomography|Undergo PET/CT
15849044|NCT04050215|Other|Questionnaire Administration|Ancillary studies
15849045|NCT04050202|Behavioral|Attachment and Biobehavioral Catch-up (ABC) Intervention|ABC is a 10 session, home-based, dyadic therapy that is delivered by a trained professional. The sessions focus on improving the parent-child relationship and children's biological and behavioral responses to stress.
15849046|NCT04050189|Biological|Natural products: Probiotics|Probiotics intake every day (1.5 gram) from 34 weeks of gestation to delivery OR from delivery to 10 days postpartum
15849047|NCT04050189|Other|Placebo|Placebo intake every day (1.5 gram) from 34 weeks of gestation to delivery OR from delivery to 10 days postpartum
15849048|NCT04050176|Behavioral|Hypnotic Medication Open-Label Taper|Participants will have their soporific hypnotic medication dosage reduced by 25% every two weeks during a 10 week open-label tapering period.
15849049|NCT04050176|Behavioral|Hypnotic Medication Blinded Taper|Participants will have their soporific hypnotic medication dosage reduced by 25% every two weeks during a 10 week blinded tapering period.
15849050|NCT04050163|Biological|MiSaver®|Intravenous administration of MiSaver® Stem Cell via peripheral vein access.
15849051|NCT04050150|Behavioral|Arm training in standing|Arm training will be provided in one hour sessions, 3 time per week for 8 weeks. In each session, you will practice functional tasks with your weaker arm and hand in standing or during walking. Practice will be scaled to match your current level of function and progressed over time as able.
15849052|NCT04050137|Other|Therapeutic Exercise|"Patients who meet the inclusion criteria and who want to carry out the workshops, fill out an informed consent explaining the procedure to be followed and accepting the cessation of data to carry out the study.
~Patients will be divided into 2 working groups (approximately 10 patients in total, in a Gaucher disease group and in another Fabry disease). The workshops will be held at the foundation twice a month in sessions of 45 minutes of work for 3 months (May, June, July 2019). In these sessions the physiotherapists will show the new exercises to the patients. The exercises that are taught in that session should be done at home 3 times a week. In addition, a document will be delivered with the exercises to be carried out and the frequency and intensity of execution. The workshops will be guided at all times by a physiotherapist specialized in therapeutic exercise and EDL."
15849053|NCT04050124|Drug|Promogran Prisma|Promogran+SOC; composite collagen, silver-oxidized regenerated cellulose matrix
15849054|NCT04050124|Other|Standard of care (SOC) dressings|standard of care dressing on donor site pain for patients undergoing split-thickness skin grafting in preparation for a larger study.
15849055|NCT04050111|Biological|Stromal-vascular fraction|Concentrate of stromal-vascular fraction of cells derived from autologous adipose tissue
15849056|NCT04050098|Drug|gemigliptin 50 mg and metformin hydrochloride 1000 mg prolonged release|"Zemiglo Tablet 50 mg: Each tablet contains gemigliptin tartrate sesquihydrate, equivalent to 50 mg gemigliptin.
~Glucophage XR 1000 mg: Each tablet contains metformin hydrochloride 1000 mg (equivalent to 780 mg of metformin base)."
15849057|NCT04050098|Drug|Gemigliptin tartrate sesquihydrate and metformin|Each tablet contains gemigliptin tartrate sesquihydrate 68.9 mg (equivalent to gemigliptin pure free base 50 mg) and metformin hydrochloride 1000.0 mg.
15849058|NCT04050085|Biological|Nivolumab|Given IV
15849059|NCT04050085|Radiation|Radiation Therapy|Undergo radiation therapy
15849060|NCT04050085|Drug|TLR9 Agonist SD-101|Given intratumorally
15849061|NCT04050072|Other|Childhood Cancer Survivors (CCSS)|To use the PRO-CTCAE-SCC (beta version) to identify symptomatic adverse event (AEs) that are prevalent and clinically meaningful in adult survivors of childhood cancer vs. non-cancer controls, and to create symptomatic AE items that are not included in the current PRO-CTCAE for adult survivors of childhood cancer.
15849062|NCT04050072|Other|SJLIFE|To use the current PRO-CTCAE to conduct a symptom content creation process for the PRO-CTCAE-SCC by identifying clinically meaningful symptomatic AEs for adult survivors of childhood cancer, to create symptomatic AE items not included in the current PRO-CTCAE, and to perform comprehensive medical evaluation, physical performance evaluation, and neurocognitive evaluation to clinically validate the PRO-CTCAE-SCC.
15849063|NCT04050072|Other|Community non-cancer control|To use the PRO-CTCAE-SCC (beta version) to identify symptomatic adverse event (AEs) that are prevalent and clinically meaningful in non-cancer controls vs. adult survivors of childhood cancer, and to create symptomatic AE items that are not included in the current PRO-CTCAE for adult survivors of childhood cancer.
15849064|NCT04050059|Drug|EMLA cream|EMLA cream (5g tube Aspen pharma trading limited) will be applied topically in dose of 2.5 grams (half tube of cream) and area will be covered with tegaderm dressing. Application of EMLA will at least stay for 30 minutes before spinal needle insertion
15849065|NCT04050059|Drug|2% lidocaine|In 2% lidocaine group infiltration (Xylocaine 2% Barrett Hodgson Pakistan Pvt limited), skin and subcutaneous tissue will be infiltrated with 3 ml of 2% lidocaine (dose of 60 mg) before spinal needle insertion
15849066|NCT04050046|Device|Transcranial Direct Current Stimulation|tDCS is a neuromodulatory technique that delivers a small electric current (about the equivalent of a 9V battery) to the head. A fixed current between 1 and 2 mA is typically applied. tDCS works by applying a positive (anodal) or negative (cathodal) current via electrodes to an area, facilitating the depolarization or hyperpolarization of neurons, respectively.
15849067|NCT04050046|Behavioral|Computer-based cognitive therapy (CBCT)|Repetitive, drill-like training usually presented in the form of a game that targets a specific cognitive construct.
15849068|NCT04050033|Device|Evoke Device|Subjects will undergo treatment with Evoke Device
15849069|NCT04050020|Biological|Platelet-Rich Plasma (PRP)|All subjects of this group will receive 2 sessions of PRP penile injection with 30 +/- 3 day treatment interval, 10 ml of PRP will be injected at each session.
15849072|NCT04050007|Other|Curative initiation of fluid removal|"The initiation of fluid removal will be considered by the attending physician only in case of failure to the spontaneous breathing trial with a clinical suspicion of weaning induced pulmonary edema.
~The weaning process and post extubation preventive strategy will be protocolized based on the last international guidelines"
15849073|NCT04049994|Drug|Uro-Vaxom|Uro-Vaxom® (OM Pharma SA, Meyrin, Switzerland) is a lyophilized lysate of 18 E. coli strains.
15849074|NCT04049994|Drug|Placebo oral tablet|Placebo oral tablet
15849075|NCT04049981|Device|Superpower Glass|The intervention uses the outward-facing camera on the google glasses to read facial expressions and provides social cues within the child's natural environment during usual social interaction and during games accessed via the smartphone application. Participants who receive the Google Glass intervention will be asked to use it for around 20 minutes 3 times a week with their parents.
15849076|NCT04049968|Device|Mobile health application (APP)|The mobile health application (APP) was applied to patients with oral cancer.
15849077|NCT04049968|Other|Routine health care and instruction|Traditional routine health care and instruction was applied to patients with oral cancer.
15849078|NCT04049955|Procedure|endoscopy|In the case of a well-organized abscessed collection responsible for sepsis instability, or poorly organized collection, an external drainage is carried out, by a radiological or a surgical way. The endoscopy is performed 7 days later. If there is no hemodynamic instability and in presence of a well-organized abscessed collection, a first-line endoscopy is carried out. After laying 2 double pig tail stents, the external drainage is removed 2 to 7 days later.
15849079|NCT04049942|Other|Multimodal prehabilitation group|Multimodal prehabilitation strategy includes physical exercise (moderate aerobic exercise combined with resistance exercise and respiratory training ), nutritional suggestion and optimization(whey protein supplement), and psychological therapy, as well as conventional guidance (including preoperative anesthesia assessment, drug treatment recommendations for chronic disease, quit smoking and abstinence). Patients are advised to record daily exercises and adherence to nutritional, psychological and other recommendations. Short message interviews are sent to patients twice a week to optimize adherence and promote feedback.
15849080|NCT04049942|Behavioral|Aerobic training group|Aerobic training strategy includes the same guided individualized moderate aerobic exercise as the multimodal prehabilitation group, as well as the conventional guidance. Patients are advised to record daily exercises. Short message interviews are sent to patients twice a week to optimize adherence and promote feedback.
15849081|NCT04049929|Drug|YY-20394|YY-20394 is a new type of PI3K-δ selective inhibitor which differs structurally from idelalisib and its analogs, showing high potency against PI3Kδ, but with markedly improved selectivity (>1,000-fold selectivity for PI3K-δ versus PI3Kγ). This higher selectivity for PI3Kδ may decrease the risk of serious infection seen with idelalisib and especially with duvelisib due to strong immune suppression.Preclinical evaluation has demonstrated improved efficacy and safety for YY-20394 compared to idelalisib.
15849082|NCT04049916|Drug|Pyronaridine Tetraphosphate/Artesunate|Adults: Tablets containing 180 mg pyronaridine-tetraphosphate/60mg artesunate (Pyramax, Shin Poong Pharmaceutical Co.), administered according to weight. Children: Granules containing 60 mg pyronaridine-tetraphosphate/20mg artesunate, administered according to weight.
15849083|NCT04049916|Drug|Dihydroartemisinin/Piperaquine|Tablets containing 40 mg dihydroartemisinin/320 mg piperaquine tablets (Eurartesim, Sigma Tau), administered according to weight.
15849084|NCT04049916|Drug|Primaquine Diphosphate|Extemporaneous preparation of 1mg/mL primaquine phosphate solution, from tablets containing 30mg primaquine (A-PQ 30®, ACE pharmaceuticals, NL) dissolved in 30mL water with a non-interacting fruit-flavoured syrup. Solution will be given at 0.25mg/kg.
15849085|NCT04049903|Drug|MP0310 (AMG 506)|MP0310 will be examined for safety, tolerability, PK, and PD activity in subjects with advanced solid tumors
15849086|NCT04049890|Other|FAI-O|"Administration of Family Adjustment Inventory in the version Only-child"
15849087|NCT04049890|Other|FAI-S|"Administration of Family Adjustment Inventory in the version Sibling"
15849088|NCT04049890|Other|Personal Data Questionnaire|This form requires informations about child, respondent and partner (if any), and evaluates the presence of any distressful event happened during the last year
15849089|NCT04049877|Other|None - Observational study|None - Observational study
15849090|NCT04049864|Biological|DNA vaccine|conjugate of plasmid DNA with linear polyethylenimine 20 kDa (PEI) One dose includes 400 µg of DNA and 500 µg of PEI.
15849091|NCT04049864|Biological|Salmonella oral vaccine|suspension 10^10 CFU of an attenuated Salmonella enterica serovar typhimurium strain (SS2017) containing the plasmid of the corresponding DNA vaccine.
15849092|NCT04049864|Drug|Lenalidomide|Lenalidomide is prescribed in a dose of 25 mg / day in a course of three weeks starting 7 days before the first vaccination course and ending on the day of the last vaccination course.
15849093|NCT04049851|Drug|Moxidectin 2 MG Oral Tablet|One Moxidectin 2 mg tablet will be blinded and will be administrated with 3 tablets of placebo.
15849094|NCT04049851|Drug|Ivermectin 3Mg Tab|3 ivermectin tablets (or 4 according to the weight) will be blinded and will be administrated with 1 (or 0 according to the weight) tablet of placebo.
15849095|NCT04049851|Drug|Placebo oral tablet|Placebo will be administrated with Moxidectin or ivermectin. Each participant will have 4 tablets in total.
15849096|NCT04049838|Procedure|postoperative analgesia for lower abdominal surgery in children|compare lateral and posterior approaches of trannsversus abdominis plane block for analgesia after lower abdominal surgery in children
15849099|NCT04049812|Device|PEMF|
15849100|NCT04049812|Device|Hot pack|
15849101|NCT04049812|Device|TENS|
15849102|NCT04049812|Device|Sham PEMF|
15849103|NCT04049799|Other|Medically-supervised withdrawal|6-8 day withdrawal with buprenorphine/naloxone
15849104|NCT04049799|Other|Opioid agonist treatment|Induction and maintenance with buprenorphine/naloxone
15849105|NCT04049799|Behavioral|Comprehensive clinical care|Obstetrical visits, counseling, case management, psychiatry services, and urine drug screening
15849106|NCT04049786|Procedure|Roux-en-Y gastric bypass bariatric surgery|Patients with body mass index equal or higher 35 mgkg/mˆ2 and with indication for RYGB bariatric surgery are being recruited for the present investigation.
15849109|NCT04049786|Procedure|Serial blood sampling for carvedilol|Serial blood samples are being collected at times 0, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 15, 18 and 24 hours after carvedilol administration.
15849110|NCT04049786|Drug|Metoprolol 100 mg|Metoprolol is being used as probe drug to evaluate CYP2D6 activity. Single-dose of metoprolol 100 mg are being administrated orally.
15849111|NCT04049786|Procedure|Urine sampling|Urine sample is being collected until 8 hours after metoprolol 100 mg administration.
15849112|NCT04049786|Procedure|Serial blood sampling for simvastatin|Serial blood samples are being collected at times 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 12 and 24 hours after simvastatin administration.
15849113|NCT04049786|Drug|Simvastatin 40mg|Single-dose of simvastatin 40 mg are being administrated orally.
15849114|NCT04049786|Drug|Midazolam 2 mg|Midazolam is being used as probe drug to evaluate CYP3A4 activity. Single-dose of midazolam 2 mg are being administrated intravenous.
15849115|NCT04049786|Procedure|Blood Sampling|Blood sample is being collected 4 hours after midazolam administration.
15849116|NCT04049786|Procedure|DNA extraction|Blood sample is being collected for DNA extraction. DNA are being extracted from the whole blood of all patients.
15849117|NCT04049786|Other|CYP2C9 genotyping|Patients are being genotyped for CYP2C9 432C>T (rs1799853) and 1075A>C (rs1057910) polymorphisms.
15849118|NCT04049786|Other|ABCB1 genotyping|Patients are being genotyped for ABCB1 1236C>T (rs1128503), 2677nonG (rs2032582), and 3435C>T (rs1045642) polymorphisms.
15849119|NCT04049786|Other|SLCO1B1 genotyping|Patients are being genotyped for SLCO1B1 521C>T (rs4149056) polymorphism.
15849120|NCT04049773|Procedure|haemodialysis|haemodialysis, thrice weekly in-center
15849121|NCT04049760|Drug|migalastat HCl 150 mg|migalastat HCl 150 mg capsule
15849122|NCT04049747|Procedure|Radical therapy (radiotherapy or prostatectomy [radiotherapy can be external beam or brachytherapy]|Radical therapy (radiotherapy or prostatectomy [radiotherapy can be external beam or brachytherapy]
15849123|NCT04049747|Procedure|Focal therapy|Focal therapy (high intensity focused ultrasound or cryotherapy)
15849124|NCT04049747|Procedure|Focal therapy after Finasteride 5Mg tablets for 12 weeks|finasteride 5mg tablets 12 weeks prior to focal therapy
15849125|NCT04049747|Procedure|Focal therapy after Bicalutamide 50Mg tablets for 12 weeks|Bicalutamide 50mg per day - 12 weeks prior to focal therapy
15849126|NCT04049734|Drug|oral losatan|50 mg of oral losartan one hour before the ERCP once
15849127|NCT04049721|Procedure|HBO|2.5 atmospheres absolute (ATA) with 90 minutes of hyperbaric oxygen will be given over the course of two weeks.
15849128|NCT04049721|Other|Standard of Care|20 patients will be included in the retrospective review arm. The retrospective chart review will be performed to determine the outcomes of patients with crush injuries treated at NYU Winthrop Hospital without HBO from 1/1/2012-12/31/2018.
15849129|NCT04049708|Other|Reliability of physical function|Test-retest reliability of physical function in hemodialysis patients
15849130|NCT04049695|Behavioral|Exercise|This intervention is based on Control Theory and Social Cognitive Theory and includes: 1) weekly emails with tips and tools to set personalized exercise goals and to increase exercise; 2) Health coaching phone sessions; 3) wrist worn monitor such as a Fitbit to track activity
15849131|NCT04049695|Behavioral|Control|This intervention includes: 1) weekly emails with tips and tools to support health and wellness such as brain health, stress management, nutrition; 2) Health coaching phone sessions
15849132|NCT04049682|Behavioral|Delayed School Start Time|Francis Parker High School implemented 45-minute later school start time.
15849133|NCT04049669|Drug|Indoximod|Indoximod will be taken by mouth twice daily during radiation and until the first cycle of Core Regimen therapy.
15849134|NCT04049669|Radiation|Partial Radiation|Palliative low-dose or partial-field radiation plan (low-dose radiation or not all disease sites included).
15849135|NCT04049669|Radiation|Full-dose Radiation|Palliative full-dose radiation plan to all known sites of disease (>50 Gy to brain, >45 Gy to spine).
15849136|NCT04049669|Drug|Indoximod|Indoximod will be taken by mouth twice daily, throughout each chemo-immunotherapy treatment cycle.
15849137|NCT04049669|Drug|Temozolomide|Temozolomide will be taken by mouth once daily, on days 1-5 of each treatment cycle.
15849138|NCT04049669|Drug|Cyclophosphamide|Cyclophosphamide will be taken by mouth once daily, on days 1-21 of each treatment cycle.
15849139|NCT04049669|Drug|Etoposide|Etoposide will be taken by mouth once daily, on days 1-21 of each treatment cycle.
15849140|NCT04049669|Drug|Lomustine|Lomustine will be taken by mouth once daily, on day 1 of each treatment cycle.
15849141|NCT04049656|Device|HFVI|Subjects in the HFVI intervention group will be monitored in the same manner as the control group, but the HFVI monitor display will also be available to the anesthesia provider in real time. Bolus doses of 25ug or 50 ug of fentanyl will be recommended to be administered when the HFVI values begin to decrease below 50, and as needed based on the judgment of the clinician responsible for the case. All anesthetic medications that are given, patient events, and vital sign recordings will be included in the anesthetic record and data collection forms.
15849142|NCT04049643|Device|Audiologist-based fitting|Hearing aids will be fitted by audiologists using established procedures.
15849143|NCT04049643|Device|Service-only Fitting|This intervention group is designed to explore the contribution of amplification devices in hearing aid intervention, which consists of devices and services. In this intervention group, audiological services plus hearing aids that provide minimum amplification will be provided. Specifically, patient participants in this group will receive audiological services (e.g., counselling and education), except that the hearing aids will be set to provide no amplification other than what is needed to overcome any sounds that are dampened by the earpieces.
15849144|NCT04049643|Device|Device-only fitting|This intervention group is designed to explore the contribution of amplification devices in hearing aid intervention, which consists of devices and services. The patient participants in this intervention group will have minimum services regarding the pre-fitting, selection, and orientation of the hearing aids. The participants will have a hearing evaluation, including pure-tone audiometry. The audiologist will select the amplification characteristics and non-custom ear piece based on the audiogram. The audiologist will then briefly orient the participant on how to use the hearing aids and counsel on how to optimize their performance.
15849145|NCT04049630|Drug|LEV 1 mg/kg|A combinaison of LEV 10 mg, 50 mg, and placebo will be adapted to the weight ; all the tablets will be blinded, and each participant will receive 5 tablets.
15849146|NCT04049630|Drug|LEV 1,5 mg/kg|A combinaison of LEV 10 mg, 50 mg, and placebo will be adapted to the weight ; all the tablets will be blinded, and each participant will receive 5 tablets.
15849147|NCT04049630|Drug|LEV 2,5 mg/kg|A combinaison of LEV 10 mg, 50 mg, and placebo will be adapted to the weight ; all the tablets will be blinded, and each participant will receive 5 tablets.
15849148|NCT04049630|Drug|Placebo|5 tablets of placebo will be administrated to the participants.
15849149|NCT04049617|Drug|GS-4224|Tablets administered orally.
15849150|NCT04049591|Drug|Higher Dose UFH|Centre wide policy of administering 100 U/kg bolus of intravenous UFH for elective PCI procedures
15849151|NCT04049591|Drug|Lower Dose UFH|Centre wide policy of administering 70 U/kg bolus of intravenous UFH for elective PCI procedures
15849152|NCT04049578|Drug|Balovaptan|Participants were to receive an oral dose of balovaptan once a day (QD) for a 6-week treatment period, followed by an optional extension period of 48 weeks.
15849153|NCT04049565|Diagnostic Test|Procalcitonin biomarker and CRP biomarker|collecting blood samples to measure serum CRP and Procalcitonin
15849154|NCT04049552|Drug|Rapamycin 8% Ointment|A compounded ointment containing 8% rapamycin
15849155|NCT04049552|Drug|Placebo|Petrolatum ointment placebo
15849156|NCT04049539|Drug|Liposome-encapsulated Daunorubicin-Cytarabine|Given IV
15849157|NCT04049526|Behavioral|The influence of different music genres on Heart Rate Variability (HRV) in preterm infants|Neonates undergo a daily randomized music listening program (25 minutes, every day, for 3 days) based on different music genres listening (soft pop-rap, pop-rock and classical music). Music programs is followed by 1 day of no music monitoring (25 minutes). An electrocardiogram is performed to evaluate HRV parameters in each neonate with and without music exposure
15849158|NCT04049513|Biological|WZTL002-1 (1928T2z CAR-T cells)|WZTL-002 comprises autologous third-generation anti-CD19 chimeric antigen receptor T-cells (termed 1928T2z). The chimeric antigen receptor in WZTL-002 incorporates the FMC63 anti-CD19 soluble chain variable fragment extracellularly, and portions of both CD28 and the Toll/interleukin-1 receptor (TIR) domain of Toll Like Receptor 2 (TLR2) as intracellular co-stimulatory domains, alongside CD3ζ. WZTL-002 (autologous 1928T2z CAR T-cells) will be administered on D0 as a single IV infusion, following lymphodepleting chemotherapy.
15849159|NCT04049513|Drug|Cyclophosphamide and Fludarabine lymphodepleting chemotherapy|Cyclophosphamide 500 mg/m^2 IV on days -5 to -3, inclusive. Fludarabine 30 mg/m^2 IV on days -5 to -3, inclusive
15849161|NCT04049487|Other|Exercise|Both groups will participate in group exercise as previously described
15849162|NCT04049474|Device|ERBOKRYO® CA - Cryosurgical Unit with Flexible ERBECRYO Probe, 1.9 mm outer diameter (ERBE Inc., Tubingen, Germany)|See BCI description.
15849163|NCT04049461|Diagnostic Test|Bone alkaline phosphatase|Hematologic indicators reflecting ossification.
15849164|NCT04049461|Radiation|Abdominal CT scan|Observe whether HOAI occurs.
15849165|NCT04049448|Drug|ABX464|All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 2 years (104 weeks).
15849166|NCT04049435|Device|Assessment of Horizontal Bone gain using patient specific titanium sheet: a novel protocol for treatment of horizontal deficiency in the anterior maxilla|Assessment of Horizontal Bone gain using patient specific titanium sheet: a novel protocol for treatment of horizontal deficiency in the anterior maxilla
15849167|NCT04049409|Drug|CMAB809|CMAB809 will be administered by IV infusion at a single dose of 6mg/kg.
15849168|NCT04049409|Drug|Trastuzumab|Trastuzumab will be administered by IV infusion at a single dose of 6mg/kg.
15849169|NCT04049396|Other|Berberine|24 Patient consumed 6,25 g/day Berberine for 6 weeks
15849171|NCT04049370|Other|No intervention|"Assessment of the actual state prior to implementation of the SOP as clinical decision tool into the electronic database of the chest pain unit."
15849172|NCT04049357|Device|Camera Capsule Endoscopy/ PillCam|Camera Capsule Endoscopy in screening
15849173|NCT04049344|Drug|Decitabine; Oxaliplatin|Patients receive Decitabine 10 mg/day for 5 consecutive days (d1-5) plus Oxaliplatin 75mg/m2 2-week-cycle (d6, d20) within 4 weeks. One cycle is defined as 4 weeks of treatment and total of 6 cycles are designed for patients.
15849174|NCT04049331|Drug|Testosterone Undecanoate 750 MG/3 ML Intramuscular Solution [AVEED]|first two doses four weeks apart; following three more doses every ten weeks.
15849175|NCT04049331|Other|placebo|first two doses four weeks apart; following three more doses every ten weeks.
15849176|NCT04049318|Other|Education+ exercise (delivered digitally)|The intervention consisted of a digital, structured and individualized treatment program for people with hip or knee OA (Joint Academy®; www.jointacademy.com). The program consists of neuromuscular exercises appropriately adjusted to each patient in regard to degrees of complexity and difficulty, continuous access to and dialogue with a physiotherapist through a chat function, and/or telephone , and information in the form of text or video lessons (with quizzes on the material after each episode) on subjects related to OA, OA symptoms and its management.
15849177|NCT04049305|Device|Robotic assisted nipple sparing mastectomy (R-NSM)|R-NSM, which introduce da Vinci surgical platform through a small extra-mammary axillary or lateral chest wound to perform NSM, had been applied in the surgical treatment of early breast cancer or risk reducing mastectomy. R-NSM, which incorporated 3-dimensional (3D) imaging system and flexibility of robotic arm and instruments, was reported to have the potential to overcome the technique difficulty of E-NSM.
15849178|NCT04049305|Procedure|conventional nipple sparing mastectomy (C-NSM)|Nipple-sparing mastectomy (NSM), which preserved the nipple areolar complex (NAC) and skin flap during mastectomy, was increasingly performed in breast cancer patients due to better cosmetic outcome, higher patient satisfaction, and maintained oncologic safety.
15849212|NCT04049123|Drug|LY900014|Administered SC
15849213|NCT04049123|Drug|Insulin Lispro (Humalog)|Administered SC
15849179|NCT04049305|Procedure|Endoscopic assisted nipple sparing mastectomy (E-NSM)|E-NSM, which is performed through small axillary and/or peri-areolar incisions, was reported to be associated with small inconspicuous incision and good cosmetic outcome. Conventional E-NSM was performed with two separate incisions over axilla and peri-areolar regions. E-NSM with areolar incision, just like NSM with areolar related incision (NAC ischemia/necrosis rate: range 7%-81.8%), was associated with increased NAC ischemia/necrosis (reported ranged: 9.1-19%). New technique modifications of E-NSM were emerging focusing on single axillary incision NSM, which spare the peri-areolar incision and thereby decrease the compromise of bloody supply from mastectomy skin flap, was reported to have low NAC necrosis rate (0%).
15849180|NCT04049292|Other|Better and safer return to sport (BEAST)|The RTS assessment includes a Lachman test, modified stroke test, side hop test, triple hop test, and quadriceps muscle power test. The sport-specific progression plans have 6 participation levels in practice and 6 participation levels in match play. A minimum of 2 weeks and 4 training sessions without pain or effusion must be completed before the athlete progresses to the next level. Criteria for full, unrestricted participation in practice: (1)at least 9 months from ACLR, (2)modified stroke test grade 0, (3)completed previous levels in the sport-specific progression plan, (4)negative Lachman test, (5)side hop test limb symmetry at least 90%, (6)triple hop test limb symmetry at least 90%, (7)quadriceps power symmetry at least 90%. The strength training and knee control exercise protocols each have 3-4 different exercises of 3-4 sets that are performed 3 days per week.
15849181|NCT04049292|Other|Usual care|Usual care is determined by the treating health care professional
15849182|NCT04049279|Procedure|BiMobile standard cement|BiMobile dual mobility cup, in a standard size after optimal reaming, resulting in a cement mantle of approximately 2mm.
15849183|NCT04049279|Procedure|BiMobile larger cement|BiMobile dual mobility cup, in one size smaller than standard after optimal reaming, resulting in a cement mantle of approximately 4mm.
15849184|NCT04049279|Procedure|Avantage standard cement|Avantage dual mobility cup, in a standard size after optimal reaming, resulting in a cement mantle of approximately 2mm.
15849185|NCT04049266|Drug|KSI-301|Intravitreal Injection
15849186|NCT04049266|Drug|Aflibercept|Intravitreal Injection
15849187|NCT04049266|Other|Sham Procedure|The sham is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It will be administered to participants in both treatments arms at applicable visits to maintain masking.
15849188|NCT04049253|Drug|Phosphate Buffer Solution|Phosphate-buffered saline (abbreviated PBS) is a buffer solution commonly used in biological research. It is a water-based salt solution containing disodium hydrogen phosphate, sodium dihydrogen phosphate. The buffer helps to maintain a constant pH. The osmolarity and ion concentrations of the solutions match those of the human body (isotonic).
15849189|NCT04049240|Device|Device: low-flow nasal oxygenation (LFNO) 18<BMI<30 kg/m2|Active comparator LFNO: O2 flow 5 L/min, FiO2 40%
15849190|NCT04049240|Device|Device: low-flow nasal oxygenation (LFNO) 30≤BMI<35 kg/m2|Active comparator LFNO: O2 flow 5 L/min, FiO2 40%
15849191|NCT04049240|Device|Device: low-flow nasal oxygenation (LFNO) BMI≥35 kg/m2|Active comparator LFNO: O2 flow 5 L/min, FiO2 40%
15849192|NCT04049240|Device|Device: High-flow nasal oxygenation (HFNO) 18<BMI<30 kg/m2|Experimental HFNO: O2 flow 40 L/min, FiO2 40%
15849193|NCT04049240|Device|Device: High-flow nasal oxygenation (HFNO) 30≤BMI<35 kg/m2|Experimental HFNO: O2 flow 40 L/min, FiO2 40%
15849194|NCT04049240|Device|Device: High-flow nasal oxygenation (HFNO) BMI≥35 kg/m2|Experimental HFNO: O2 flow 40 L/min, FiO2 40%
15849195|NCT04049227|Drug|Abemaciclib|Given PO
15849196|NCT04049227|Drug|Letrozole|Given PO
15849197|NCT04049227|Procedure|Therapeutic Conventional Surgery|Undergo standard of care hysterectomy
15849198|NCT04049214|Other|Meditation|Two guided meditations will be provided to participants. They will be asked to meditate twice daily, once in the morning once before bed, for a total time of 12 minutes per day. Surgical treatment and postoperative care will be provided by surgeon preference and usual practice, including post-operative pain medications. For 12 weeks patients will maintain a daily meditation log, medication log and complete daily pain assessment questionnaire.
15849199|NCT04049201|Procedure|elective surgery|investigators will compare the effect of interactive tablet on preoperative anxiety in children to the effect ofMidazolam in elective surgery
15849200|NCT04049201|Drug|Midazolam|Oral Midazolam
15849201|NCT04049201|Device|Interactive Tablet|interactive Tablet containing many cartoon's videos
15849202|NCT04049188|Radiation|Single-Fraction Palliative Radiation Therapy|All subjects will be undergo single-fraction palliative radiation therapy who have cancer and associated bone metastases and symptomatic bone pain.
15849207|NCT04049162|Dietary Supplement|Blueberry Plus Exercise (BB-EX)|Pre-packaged blueberry powders are from U.S. Highbush Blueberry Council and are packaged in sealed single-serving packets (18 g/packet) to prevent exposure to light and moisture. All supplement packets are stored under refrigeration until distribution to study participants. Participants will be asked to increase physical activity through a weekly supervised exercise class and increasing baseline daily step counts gradually over the course of the intervention.
15849208|NCT04049162|Dietary Supplement|Blueberry Placebo Plus Exercise (P-EX)|Pre-packaged placebo powders are from U.S. Highbush Blueberry Council and are packaged in sealed single-serving packets (18 g/packet) to prevent exposure to light and moisture. All supplement packets are stored under refrigeration until distribution to study participants. Participants will be asked to increase physical activity through a weekly supervised exercise class and increasing baseline daily step counts gradually over the course of the intervention.
15849209|NCT04049149|Other|Biogenetic explanation and endocrinologist intensive managment|"JADE report and JADE APP
~Biogenetic explanation
~First-year intensive management by endocrinologists
~Follow up by their usual care doctors for continue treatment regimen maintenance.
~Yearly DM nurses follow up for blood taking and questionnaires"
15849210|NCT04049149|Other|Usual care management|"JADE report and JADE APP
~Attend their usual care clinic for ongoing treatment
~Yearly DM nurses follow up for blood taking and questionnaires"
15849214|NCT04049110|Drug|Forxiga 10mg|Dapagliflozin 10mg per 24 hours, oral, for 7 consecutive days
15849217|NCT04049084|Biological|autologous ex vivo gene therapy products based on the EFS LV encoding for the human adenosine deaminase (ADA) gene (EFS-ADA LV)|ADA-SCID patients previously treated with autologous ex vivo gene therapy products based on the EFS LV encoding for the human adenosine deaminase (ADA) gene (EFS-ADA LV)
15849218|NCT04049045|Drug|Empagliflozin 25 mg|Empagliflozin 25 mg film-coated tablets, for oral use administered once daily for 5 days in addition to routinely administered (weight adjusted) intravenous furosemide
15849219|NCT04049045|Drug|Placebo|matching Placebo, film-coated tablets, for oral use, matching to investigational product Jardiance® administered once daily for 5 days in addition to routinely administered (weight adjusted) intravenous furosemide
15849220|NCT04049032|Behavioral|In-Person Perinatal OUD Treatment|Participants were seen weekly for four weeks, every two weeks for four weeks and monthly thereafter and provided relapse-prevention therapy and buprenorphine as part of standard of care.
15849221|NCT04049032|Behavioral|Perinatal OUD Treatment via Telemedicine|Participants were seen weekly for four weeks, every two weeks for four weeks and monthly thereafter and provided relapse-prevention therapy and buprenorphine as part of standard of care..
15849222|NCT04049019|Diagnostic Test|Urine collection through a collecting device (Uridom®) for maximum 1 week|"The child will collect:
~Urine at bedtime on a wet and a dry night.
~Urine during a wet night through a collecting device.
~First morning voided volume following both a wet and a dry night."
15849223|NCT04049006|Other|complex treatment|The complex treatment will be based on health education, aerobic physical exercise and cognitive-behavioral therapy, during 12 weeks in sessions of 2 hours/week. The sessions will be conducted in the primary health care by trained professionals.
15849224|NCT04048993|Other|Biobank development and integrative physiological analysis|Collection of biological samples (blood, urine, interstitial fluid, adipose tissue and muscle) from subjects enrolled in the Section registry, using multivariate and data-mining approaches that includes also clinical and demographic parameters.
15849225|NCT04048980|Behavioral|CARExDEM|CARExDEM is an educational program addressed to nurses working in traumatology units and looking after patients with dementia. This intervention pretends to provide strategies to nurses for cognitive impairment management in acute hospital settings, to raise awareness about personalized care in dementia and to improve continuity of care in acute situations in PwD. Training sessions will be held to inform and train nurses about care of PwD and their caregivers by the research team in each hospital.
15849226|NCT04048967|Behavioral|Professional development|professional development of preschool staff
15849227|NCT04048954|Device|Applitabac|Smartphone application in screening on tabagism complications
15849228|NCT04048941|Procedure|One Needle Hand Acupuncture with Movement|One needle is inserted along the radial aspect of the 2nd metacarpal which relieves pain at a distant site. Then, the subject is asked to perform a series of movements that were previously painful.
15849229|NCT04048941|Procedure|One Needle Hand Acupuncture without Movement|One needle is inserted along the radial aspect of the 2nd metacarpal which relieves pain at a distant site. Then, the subject is asked to lay quietly on the examination table.
15849230|NCT04048941|Procedure|Control Acupuncture with Movement|Control acupuncture at acupoint LI4 is performed, which should not have a large affect on pain at a distant site. Then, the subject is asked to perform a series of movements that were previously painful.
15849231|NCT04048928|Behavioral|maximal strength training|The training group (TG) performed MST training carried out as free-barbell squats twice a week over five weeks.
15849232|NCT04048915|Behavioral|Long live drama|"The interactive live 90-minute drama and DVD conveyed educational information on healthy living habits (including physical activity and healthy eating) as well as the importance and suggested methods to enhance family well-being. Students were encouraged to share the information on healthy living habits and watched the DVD with their parents.
~Worksheets were given to all students and encouraged to finish the worksheets with their parents."
15849233|NCT04048915|Behavioral|Short live drama|"The interactive live 60-minute drama and DVD conveyed educational information on healthy living habits (including physical activity and healthy eating) as well as the importance and suggested methods to enhance family well-being. Students were encouraged to share the information on healthy living habits and watched the DVD with their parents.
~Worksheets were given to all students and encouraged to finish the worksheets with their parents."
15849234|NCT04048902|Device|Pilates and Shortwave placebo|Pilates exercises and application of the device without produce thermal effects
15849235|NCT04048902|Device|Pilates and Shortwave active|Pilates exercises and application of the device producing thermal effects
15849236|NCT04048889|Drug|Ropivacaine 0.5% Injectable Solution|Continuous femoral nerve block with injection of 15 mls of Ropivacain 0.5% adjacent to the lateral aspect of the femoral nerve below the fascia iliaca and placement of the catheter within the vicinity of the femoral nerve, juste deep to the fascia iliaca
15849237|NCT04048889|Drug|Ropivacaine 0.5% Injectable Solution|Continuous femoral nerve block with injection of 15 mls of Ropivacain 0.5% adjacent to the lateral aspect of the femoral nerve below the fascia iliaca and placement of the catheter within the vicinity of the femoral nerve, juste deep to the fascia iliaca.
15849238|NCT04048889|Drug|Ropivacaine 0.5% Injectable Solution|Popliteal plexus block with injection of 15 mls of Ropivacain 0.5% inside the distal end of the adductor canal close to the adductor hiatus, adjacent to the femoral artery, between the medial vastus muscle and the adductor Magnus muscle, done under general anesthesia.
15849241|NCT04048863|Device|B. Braun Peripheral Advantage (PA) Program|B. Braun PA includes: Christie VeinViewer® Vision2 , Introcan Safety® IV Catheters, STEADYCare™ Smallbore Extension Set, and the PA Education
15849242|NCT04048863|Device|Hospital Standard of Care|Standard of Care for PIVC access per hospital protocol
15849243|NCT04048850|Drug|Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER]|Daily medication
15849244|NCT04048824|Behavioral|Inhibitory Learning-Based Exposure|9 weekly treatment sessions conducted individually with a therapist. Exposure is focused on maximizing the mismatch between participant's feared outcome and what actually occurred (i.e., expectancy violation). This condition includes techniques that incorporate associative learning principles such as exposure to multiple feared stimuli (i.e., deepened extinction), exposure variability in contexts and stimuli, occasional reinforcement, and mental reinstatement of inhibitory learning.
15849245|NCT04048824|Behavioral|Habituation-Based Exposure|9 weekly treatment sessions conducted individually with a therapist. Exposure is focused on fear reduction from initial fear ratings. This condition includes theoretically-consistent techniques such as staying in the situation until fear declines, repetition of exposures until fear has declined, and a gradual approach to feared stimuli using an exposure hierarchy.
15849246|NCT04048811|Drug|HSK3486|The induction dose is 0.4mg/mg. The initial maintenance dose of the first 6 subjects is 1 mg/kg/h. For the subsequent enrolled subjects, the investigator could adjust the subsequent initial maintenance dose according to the dose response of the first 6 subjects, so as to explore the optimal initial maintenance dose. The range of the initial maintenance dose is 1 (± 0.5) mg/kg/h, i.e. the minimum initial maintenance dose should not be less than 0.5 mg/kg/h, and the maximum should not be more than 1.5 mg/kg/h.
15849247|NCT04048811|Drug|Propofol|The induction dose is 2.0mg/mg. The initial maintenance dose of the first 2 subject is 5 mg/kg/h. For the subsequent enrolled subjects, the investigator could adjust the subsequent initial maintenance dose according to the dose response of the first 2 subjects, so as to explore the optimal initial maintenance dose. The adjustment range of the initial maintenance dose is 5 (± 2.5) mg/kg/h, i.e. the minimum initial maintenance dose should not be less than 2.5 mg/kg/h, and the maximum should not be more than 7.5 mg/kg/h.
15849248|NCT04048811|Drug|Propofol HSK3486|The induction dose of Propofol is 2.0mg/mgThe initial maintenance dose of HSK3486 is fixed at 1 mg/kg/h, without adjustment.
15849249|NCT04048798|Other|Oxygen therapy via HFNC|Oxygen treatment will be applied to the patients via HFNC before and after surgery
15849250|NCT04048798|Other|Oxygen therapy via face mask|Oxygen treatment will be applied to the patients via face mask before and after surgery
15849251|NCT04048785|Other|Behavioral sleep intervention|The intervention consists of an infant behavioral sleep protocol. In the tailored intervention approach, parents are asked to implement the behavioral protocol at bedtime and at subsequent night wakings.
15849252|NCT04048772|Behavioral|CALM IVF|The intervention will be three 1-1.5 hour interactive sessions that are scheduled throughout the participant's first in vitro fertilization cycle. These sessions will provide additional time for discussion about treatment with providers, learning opportunities on topics of interest to fertility patients, and stress reduction techniques.
15849253|NCT04048772|Other|Standard of Care|Patients will receive the standard of care IVF treatment at the University of Iowa.
15849254|NCT04048759|Behavioral|Remote Low|Participants will attend 40 min remotely delivered group MVPA sessions once a week, receive a step counter, access to resources for increasing MVPA, and one 20-min remotely delivered individual support/education session/wk.
15849255|NCT04048759|Behavioral|Remote High|Participants will attend 40 min remotely delivered group MVPA sessions 3x a week, receive a step counter, access to resources for increasing MVPA, and one 20-min remotely delivered individual support/education session/wk.
15849256|NCT04048759|Behavioral|Personal Coach|Participants will receive a step counter, access to resources for increasing MVPA, and monthly remote individual support/education.
15849257|NCT04048733|Device|patchy-type wireless 12-lead ECG|Perform 12-lead ECG using patchy-type wireless 12-lead ECG. This device automatically record 12-lead ECG in every 15 minutes by its algorithm.
15849258|NCT04048720|Behavioral|Family Nurture Intervention|The mother-child pair will be asked to talk and play with each other as the pair customarily does. If the child becomes restless and dysregulated, the mother will be coached by the Nurture Specialist to bring the child back into a calm state through sustained physical contact, comforting touch, soothing words and eye contact. Each dyad will be offered eight group FNI sessions.
15849259|NCT04048707|Drug|Angiotensin II|Intravenous
15849260|NCT04048707|Drug|Midodrine|Pill
15849261|NCT04048707|Drug|Octreotide|Subcutaneous
15849262|NCT04048707|Drug|Albumin solution|Intravenous suspension
15849263|NCT04048681|Behavioral|diet soda|12 oz can of artificially sweetened cola beverage (Diet Coke planned to be used but similar to Diet Pepsi or other Diet Colas)
15849264|NCT04048681|Behavioral|Regular soda|12oz can of regular cola beverage (Coke planned but similar to Pepsi or other regular cola sodas)
15849265|NCT04048681|Behavioral|Carbonated Water|12oz can of carbonated water (sparking water, selzter water) unflavored
15849266|NCT04048668|Device|Transcranial Direct Current Stimulation (tDCS)|tDCS is a non-invasive brain stimulation technique by which very small electrical currents (2 mA) are applied to the scalp.
15849267|NCT04048655|Drug|Neostigmine, Combinations|All patients have neostigmine induced recovery of neuromuscular block.
15849268|NCT04048642|Behavioral|DASH|7 days of a DASH diet
15849269|NCT04048642|Behavioral|Whole-Food, Plant-Based|7 days of a WFPB diet
15849270|NCT04048629|Device|Point-of-care (POC) viral load (VL) testing plus refresher training|VL testing at the first antenatal care visit will occur using POC VL testing in pregnant women, and a refresher training on Zimbabwe's guidelines will be provided at all facilities
15849271|NCT04048629|Other|Standard of care central laboratory VL testing plus refresher training|VL testing at the first antenatal care visit will occur using central laboratory VL testing in pregnant women, and a refresher training on Zimbabwe's guidelines will be provided at all facilities
15849272|NCT04048616|Dietary Supplement|whey protein isolate|one 15-25 gm (based on body weight) protein packet three times a day with each meal
15849273|NCT04048616|Dietary Supplement|potassium bicarbonate (KHCO3)|two 13.5 mmol capsules three times a day with each meal
15849274|NCT04048616|Other|microcrystalline cellulose|identical placebo capsule
15849275|NCT04048616|Other|maltodextrin powder|isocaloric placebo powder
15849276|NCT04048590|Other|Skilled Nursing Facility at Home|We plan to deploy an innovative and tailored set of rehabilitation services delivered in a patient's home that would allow for discharge from the hospital directly to home, despite the need for more intensive rehabilitative care not currently found in the home setting. We plan to combine a high-touch and high-tech approach that combines novel uses of personnel practicing at the very top of their license with novel uses of technology.
15849277|NCT04048577|Drug|Dosing Interruption of Natalizumab|Planned 12 week dosing interruption of natalizumab
15849296|NCT04048356|Drug|Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.|Vaginal scrub, to be applied vaginally and perineally immediately prior to surgery.
15849297|NCT04048343|Drug|Biological: Experimental: Tezepelumab|Tezepelumab subcutaneous injection every 4 weeks
15849278|NCT04048551|Behavioral|Modified Health Policy Project (HPP) HIV-Stigma and Discrimination Reduction Training Curriculum|The Health Policy Project (HPP) training curriculum provides participatory training modules that address three key actionable drivers of HIV-stigma. The HPP curriculum was adapted through participatory workshops with key stakeholders representing clinics, study staff, and adolescent girls and young women (AGYW) and other formative activities. The training is a whole-site training to address barriers to accessing clinical services by AGYW. Consequently, staff at all levels (clinical and nonclinical) will be trained on stigma and discrimination as it relates to AGYW in order to reduce stigma-related barriers to healthcare and increase uptake of PrEP and sexual and reproductive health services among AGYW.
15849279|NCT04048551|Behavioral|Young Women's Health CoOp (YWHC)|In this study, researchers adapted the Young Women's Health CoOp (YWHC) evidence-based empowerment intervention that addresses issues of gender-based violence (GBV), substance use, and sexual risk to include information about PrEP (pre-exposure prophylaxis) and sexual and reproductive health. AGYW will be provided with comprehensive information and will engage in activities that seek to reduce HIV risk factors and increase PrEP readiness, uptake and adherence.
15849282|NCT04048525|Procedure|CVVHD|CVVHD will be used during 72 hours with a prescribed dose of 30 ml/Kg/h Prismasol® 4 as dialysate fluid. Blood flow of 200-250 ml/min, to achieve 12 - 15 L/h will be prescribed. Isovolemic CRRT will be encouraged during this 72 hours if volume overload status is not present. After 72 hours, CVVHD will be continued and dialysate dose (ml/kg/h) will be adjusted to achieve creatinine levels between 80-120 umol/L until patient recovers urine output and / or tolerates intermittent hemodialysis.
15849283|NCT04048525|Procedure|CVVH|CVVH will be used during 72 hours with a prescribed dose of 30 ml/Kg/h Prismasol® 4 as reposition fluid. Blood flow of 200-250 ml/min, to achieve 12 - 15 L/h will be prescribed adjusting the adequate percentage of prefilter infusion to maintain a theoretical filtration fraction between 18-22%. Isovolemic CRRT will be encouraged if volume overload status is not present. After 72 hours, CVVH will be continued and filtration dose (ml/kg/h) will be adjusted to achieve creatinine levels between 80-120 umol/L until patient recovers urine output and / or tolerates intermittent hemodialysis.
15849286|NCT04048499|Device|the Colour Assessment and Diagnosis (CAD) test|The CAD test (City Occupational Ltd, London, UK) measures the severity of red-green and yellow-blue colour vision loss according to red-green and yellow-blue thresholds which are expressed in CAD units and diagnoses accurately the subject's class of colour vision
15849287|NCT04048486|Other|Developmental score according to The Ages & Stages Questionnaires®, Third Edition - ASQ®-3|Ages & Stages Questionnaires®, Third Edition (ASQ®-3) is a developmental screening tool designed for use by early educators and health care professionals. It relies on parents as experts, is easy-to-use, family-friendly and creates the snapshot needed to catch delays and celebrate milestones.
15849288|NCT04048486|Other|Physical development and General Health|Physical development and General health examination
15849289|NCT04048486|Other|Developmental Red flags|Developmental Red flags Questionnaires
15849290|NCT04048460|Device|Delivery of hearing healthcare through eAudiology application|Participants will receive bilateral, behind-the-ear hearing aids as part of this study. The intervention will involve e-Audiology sessions following the initial hearing aid fitting and orientation. E-Audiology sessions will consist of hearing aid follow-up programming, troubleshooting, HAT assistance, and general help with hearing devices. E-Audiology sessions will take place over the course of approximately 6 weeks.
15849291|NCT04048434|Device|Cytosorb|extracorporeal cytokine adsorption
15849292|NCT04048421|Procedure|hvNOTES radical colectomy|With the patient under general anesthesia, pneumoperitoneum is achieved. Three trocars are inserted, one 12 mm or 5 mm in the umbilicus and two 5 mm in the right and/or left flanks. Mobilization of the splenic flexure or the hepatic flexure is performed with an initial traditional laparoscopic approach. A single-port is inserted into the abdominal cavity transvaginally through the colpotomy. Then most of the procedures are performed transvaginally with conventional rigid laparoscopic instruments. The corresponding arteries and veins are divided. The mesocolon is mobilized. The small intestine/colon/rectum are then divided with stapler. The specimen is removed transvaginally. Intracorporeal anastomosis is performed as per the surgeon's standard of care. For sigmoidectomy, the colon is then exteriorized and the anvil is fixed in the colon. An end-to-end anastomosis is performed using a circular stapler. Drainage tubes may be used.
15849293|NCT04048382|Behavioral|Patient Navigation|Spanish-English bilingual peer lay navigators hired by Family Health Centers of San Diego will provide the PN intervention during the study, trained using manuals developed in formative research and via the Patient Navigation Research Program training approach. Services will generally focus on: 1) overcoming community, health system, interpersonal, and individual barriers to accessing PrEP-related healthcare; 2) increasing each patient's knowledge, attitudes, and self-efficacy for initiating and adhering to PrEP; 3) improving communication between the patient and healthcare team through appointment scheduling and reminders; and 4) sexual risk reduction counseling.
15849294|NCT04048382|Other|Usual Care|The booklet given is a 2-page booklet including the following information: 1) overview of PrEP; 2) eligibility for PrEP; 3) efficacy of PrEP; 4) safety of PrEP; and 5) obtaining, initiating, and adhering to PrEP. Participants will also be provided with both verbal and written information regarding available sexual health and HIV prevention services, including PrEP, at Family Health Centers of San Diego (FHCSD). Comprehensive HIV-prevention healthcare, including PrEP, is available to study participants at FHCSD at no or minimal cost. If a UC participant is diagnosed with a sexually transmitted infection, including HIV, treatment and follow-up will be coordinated by FHCSD staff as per usual care procedures.
15849295|NCT04048369|Diagnostic Test|Rapid diagnosis of influenza in the emergency medical service|Comparison at the University Hospital of Clermont-Ferrand of a test performed in the Adult Emergencies Department by the nursing staff (point-of-care testing) to a test carried out in the core laboratory (classical testing).
15849392|NCT04047680|Drug|Sofosbuvir Tablets|Sofosbuvir plus ribavirin (RBV) or daclatasvir (DCV) for 12 weeks
15849298|NCT04048317|Drug|HepaSphere Microspheres/Doxorubicin Hydrochloride|"evaluation the tumor (size, location and pattern of enhancement) ;and ensure portal vein patency; then evaluation of hepatic arterial anatomy, after that we determine the tumor arterial feeders and the arteries that should be avoided during the maneuver.
~Selective celiac and superior mesenteric angiograms were performed using 5 Fr. Catheter then superselective angiogram were used microcatheter. then injection of drug-eluting microsphere (25 mg Hepasphere 50-100 micron) loaded with 50 mg doxorubicin solution for 2 hours."
15849299|NCT04048317|Drug|Lipiodol|"evaluation the tumor (size, location and pattern of enhancement) ;and ensure portal vein patency; then evaluation of hepatic arterial anatomy, after that we determine the tumor arterial feeders and the arteries that should be avoided during the maneuver.
~Selective celiac and superior mesenteric angiograms were performed using 5 Fr. Catheter then superselective angiogram were used microcatheter. then injection of prepared mixture of Lipiodol and (Doxorubicin or 5-FU) vary in dosage depend on operator consideration"
15849300|NCT04048304|Drug|duration of standard antibiotic therapy|antibiotic therapy for spine infections. 3 vs 6 weeks if no implant left in place. 6 vs 12 weeks if implant left in place. The antibiotic agents used are officially indicated for orthopedic infections, including spine infections and available in Switzerland since decades. Standard dosing will be applied and only modified according to the patient's co-morbidities, intolerances and weight.
15849301|NCT04048291|Behavioral|Brisk walking and balance training|6 months of combined brisk walking and balance training
15849302|NCT04048291|Behavioral|Upper limb exercise|6 month of hand dexterity training
15849303|NCT04048278|Drug|Lidocaine Hydrochloride|IV Lidocaine a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control
15849304|NCT04048278|Drug|Saline Solution for Injection|IV Saline a 1.0 - 1.5 mg/kg loading infusion for perioperative pain control
15849305|NCT04048265|Device|Repetitive Transcranial Magnetic Stimulation|Transcranial magnetic stimulation (TMS) is a non-invasive method that uses electromagnetic induction to produce electric currents in the cortex that are strong enough to depolarise neurons sufficiently to trigger action potentials. It is an outpatient based procedure that when used in conjunction with a neuro-navigation system, specific cortical areas can be targeted for greater accuracy and efficacy. In clinical studies, TMS is delivered as trains of pulses (repetitive TMS, rTMS) to prolong its effects. While the exact mechanism of TMS-induced analgesia is unknown, it is thought to regulate the activity of the complex cortical and subcortical networks involved in the processing of painful signals and possibly strengthening the endogenous descending pain modulation system
15849308|NCT04048239|Procedure|cochlear implantation|cochlear implantation is a system developed to restore hearing in people with profound sensorineural hearing loss, whose classical hearing aids are ineffective. Surgery is necessary to insert the internal part into the cochlea and requires milling the mastoid to access the round window. This approach is technically difficult, and is performed under a microscope by an experienced surgeon.
15849309|NCT04048239|Other|computerized tomography (CT) scan|computerized tomography (CT) scan of the facial nerve
15849310|NCT04048239|Other|electromyograph|electromyographic verification of the facial nerve
15849311|NCT04048226|Drug|Placebos|The patients in this group will be connected to the syringe pump that contain normal saline with starting infusion at a rate of 0.1 ml/kg/hr till the end of the surgery.
15849312|NCT04048226|Drug|Dexmedetomidine +Ketamine|The patients in this group will be connected to the syringe pump that contain mixture of dexmedetomidine and ketamine with starting infusion at a rate of 0.1 ml/kg/hr till the end of the surgery. The solution will contain 2 ug dexmedetomidine/ml and 1 mg ketamine/ml.
15849313|NCT04048213|Other|questionnaire|questionnaire send to the parents
15849314|NCT04048200|Drug|Fentanyl|Anesthesia will be induced by fentanyl, propofol, and rocuronium with maintenance of anesthesia using sevoflurane.
15849315|NCT04048200|Drug|Dexmedetomidine Ketamine|No opioid will be used in induction of anesthesia. A combination of dexmedetomidine and ketamine will be infused. Sevoflurane will be used for maintenance of anesthesia.
15849316|NCT04048187|Device|Phone Application|Phone application is developed to adjust hearing aids. It incorporates functionalities like volume control and program change.
15849317|NCT04048174|Other|Topical probiotic treatment with Lactococcus lactis W136|Nasal and sinus irrigation with reconstituted live probiotic bacteria
15849318|NCT04048174|Other|Saline irrigation|Nasal and sinus irrigation with saline solution
15849319|NCT04048161|Drug|Tacrolimus|"The patients will be divided into two groups randomly. Tacrolimus dose: 0.05-0.10 mg/kg/day, BID. The concentration for tacrolimus is 5-10 ng/ml，then reduce the dosage of drugs to maintian the concentration for tacrolimus is < 5ng/ml. Total duration : 1 year.
~Steroid dose: 1.0-1.5 mg/kg, qod or 0.5-0.75 mg/kg/day, qd， then gradually taper the steroid to 5mg/day."
15849320|NCT04048161|Drug|Mycophenolate Mofetil|"The patients will be divided into two groups randomly. Mycophenolate Mofetil dose: 20~30mg/kg/day，BID. The concentration for MPA-AUC is 30~50 μg.h/ml，then reduce the dosage of drugs to maintian the concentration for MPA-AUC is ≤40 μg.h/ml. Total duration : 1 year.
~Steroid dose: 1.0-1.5 mg/kg, qod or 0.5-0.75 mg/kg/day, qd， then gradually taper the steroid to 5mg/day."
15849321|NCT04048148|Device|Novel designed myopia control spectacle lenses|A novel designed myopia control spectacle lenses (test lenses) will be given to both arms to wear for 12 months.
15849322|NCT04048135|Drug|BIO89-100|Subcutaneous injection
15849323|NCT04048135|Other|Placebo|Subcutaneous injection
15849346|NCT04047953|Drug|Paclitaxel (albumin-bound) combined with Oxaliplatin and S-1|Paclitaxel (albumin-bound) : 150 mg/m2, iv,d1. S-1 : 40~60mg，bid, d1-14( BSA<1.25m2，40mg；1.25m2≤BSA≤1.5m2，50mg；BSA>1.5m2，60mg) Oxaliplatin: 85mg/m2, iv, d1. Twenty-one days per cycle, a total of four cycles, after two cycles of treatment, the tumor was evaluated. The clinical efficacy was evaluated as CR\PR\SD and decided by the investigator to continue the treatment for two cycles or directly.
15849347|NCT04047940|Drug|LY900020|Administered orally
15849348|NCT04047940|Drug|Metformin XR|Administered orally
15849349|NCT04047940|Drug|Atorvastatin|Administered orally
15849350|NCT04047940|Drug|Valsartan|Administered orally
15849324|NCT04048122|Behavioral|MultiContext for PD Strategy Training|This treatment is task-oriented training, a widely-used approach in neurorehabilitation, that parallels the cognitive process training used in PD to-date but with simulated functional tasks (vs. computer or paper & pencil tasks). It has the same basic protocol as MC4PD, but it is therapist-directed, and the OT does not address strategies, metacognition, generalization, or use mediation or action plans. The OT selects treatment activities based on the client's cognitive profile and goals from a published set of activities designed for use in cognitive interventions. Graded task practice with OT feedback on performance accuracy is used to produce neurocognitive improvement (or possibly independent strategy development). The OT assigns practice of specific cognitively challenging everyday life activities for homework (but without action plans).
15849325|NCT04048122|Behavioral|Standard of Care|This treatment is task-oriented training, a widely-used approach in neurorehabilitation, that parallels the cognitive process training used in PD to-date but with simulated functional tasks (vs. computer or paper & pencil tasks). It has the same basic protocol as MC4PD, but it is therapist-directed, and the OT does not address strategies, metacognition, generalization, or use mediation or action plans. Therefore, this is a standard-of-care approach that includes all but the proposed critical elements of MC4PD. The OT reviews pre-treatment cognitive test scores with the client but without discussion to build awareness. The OT selects treatment activities based on the client's cognitive profile and goals from a published set of activities designed for use in cognitive interventions.
15849326|NCT04048096|Dietary Supplement|Krill Oil|Aker Biomarine Superba Krill Oil
15849327|NCT04048096|Dietary Supplement|Placebo|Mixed vegetable oil
15849328|NCT04048083|Behavioral|Mental trainings|Patients will receive 36 trainings (12 weeks with 3 trainings a week) of mental, kinesthetic reaching-to-grasp movement. During each training session they will perform 3 practice trials by following the instructions, after practicing 3 trials, the instructions will be discontinued, and subjects will perform 30 mental movements by following auditory cues.
15849329|NCT04048083|Behavioral|Computer-aided trainings|Patients will receive 36 trainings (12 weeks with 3 trainings a week) of visual feedback of reaching-to-grasp movement. During each training session they will be sitting on a chair, in front of a computer screen observing simple tasks of reaching and precision fine grasping of a small object with 4 fingers of virtual upper extremity using the visualization software that will be coded specifically for the purpose of this experiment.
15849330|NCT04048083|Behavioral|Computer-aided and mental trainings|Patients will receive 36 trainings (12 weeks with 3 trainings a week) of mental, kinesthetic reaching-to-grasp movement that will be supplemented by visual feedback of this task by the visualization software that will be coded specifically for the purpose of this experiment (they will receive trainings that link the features of the two mentioned above types of training (MT and CAT).
15849331|NCT04048083|Other|No trainings|Healthy controls without any kind of training
15849332|NCT04048070|Drug|Flurbiprofen Axetil|One kind of NSAIDs, 200mg for 48 hours after surgery.
15849333|NCT04048070|Drug|Sufentanil|One kind of opioid drugs, 1.5μg/kg, and recorded the drug consumption after surgery
15849334|NCT04048070|Behavioral|Extended perioperative counseling|The extended perioperative counseling contained additional information, including surgery procedures, importance of medicine treatment and medical help to relieve depression and anxiety about disease during peri-operation period.
15849335|NCT04048070|Behavioral|Shorter fasting food and water time before surgery|The patients in ERAS group were required to fast food for 6 to 8 hours and provided 12.6% maltodextrin carbohydrate supplement beverage for 2 hours before surgery
15849336|NCT04048070|Behavioral|Conventional perioperative counseling|THe conventional perioperative counseling included the risk of surgery and prognosis of disease and other things patients need to know.
15849337|NCT04048070|Behavioral|Regular fasting food and water time before surgery|The stricter control of preoperative fasting requirements, prohibiting solids and liquids from previous midnight to operation time.
15849338|NCT04048057|Other|Exercise|"Modarete Intensity Continous Training: Medium intensity continuous exercise training will be performed. Exercise intensity will be adjusted as 50-70% of maximal power.
~High Intensity Interval Training I: It will be four cycles consisting of 4 minute high intensity exercise phase and 3 minute active recovery phase. High intensity phase will be adjusted as 85-100% of maximal power and active recovery phase as 50-70% of maximal power.
~High Intensity Interval Training II: It will be 10 cycles consisting of 1 minute high intensity exercise phase and 1 minute active recovery phase. High intensity phase will be adjusted as 85-100% of maximal power and active recovery phase as 50-70% of maximal power."
15849339|NCT04048044|Device|Exposure to GHz electromagnetic energy (RejuvaMatrix)|75 decibels of 54 to 78 GHz daily for 60 minutes
15849340|NCT04048031|Dietary Supplement|Nutrafol Supplement Capsules|NUTRAFOL's Synergen Complex Plus® is a formulation based on a patent-pending Synergen Complex®, a combination of botanicals with potent anti-inflammatory, anti-stress adaptogenic, antioxidant, DHT-inhibiting and hormone-rebalancing properties - combined to synergistically combat the multiple underlying factors that compromise hair growth and health. Some key ingredients include Sensoril Ashwagandha, BCM-95 BioCurcumin, Saw Palmetto, EVNolMax 20% Tocotrienol/Tocopherol complex, gelatinized Maca, Astaxanthin, Bioperine (piperine), and Capsimax (capsaicin), all of which are bio-optimized and clinically tested. The Nutafol supplement capsules are compared to the placebo capsules which contain no active ingredients. Four (4) capsules are taken by mouth once daily with a substantial meal.
15849341|NCT04048031|Other|Placebo Capsules|The placebo capsules contain no active ingredients. Four (4) capsules are taken by mouth once daily with a substantial amount of food.
15849342|NCT04048018|Diagnostic Test|Blood draw and IGRA test|One to two blood samples will be obtained from participants in all arms in order to conduct testing.
15849343|NCT04048005|Diagnostic Test|Fractional flow reserve|
15849344|NCT04047992|Device|Indego™ Exoskeleton|The Indego® is a powered exoskeleton that can be used as a mode of therapy in an institutional setting. Proper walking in this device requires the user to manipulate their center of gravity and balance by postural trunk excursions in order for the legs to take steps.
15849345|NCT04047979|Biological|Shingrix®|A zoster vaccine recombinant, adjuvanted, recently approved by the FDA for prevention of herpes zoster (shingles) in adults aged 50 years and older. It is given in two doses (0.5 mL each): at 0 and 2 to 6 months.
15849390|NCT04047680|Drug|Sofosbuvir / Velpatasvir Oral Tablet|Sofosbuvir/velpatasvir for 12 weeks
15849391|NCT04047680|Drug|Sofosbuvir and Ledipasvir|Sofosbuvir and ledipasvir for 12 weeks
15849351|NCT04047927|Device|EpiFinder|The EpiFinder is a sensing device intended to assist physicians performing placement of epidural needle analgesic and/or anesthesia injection in a safely and accurately manner. The device is a single use sterile device consisting of a probe (Stylet), an actuator (micro DC motor), IR sensor and Controller. The device is integrated to a standard LOR Syringe and an 18G Tuohy needle and enables to simultaneously work with the standard LOR technique.
15849352|NCT04047914|Device|pdt Photodynamic therapy|"Application of 0.01% methylene blue with enough sterile swab to cover the inner nostril extension with a 1 minute pre-irradiation time
~• Irradiations will be performed with a red laser diode (wavelength = 660 nm), 240 seconds and 4-point nostril application"
15849353|NCT04047901|Other|exercise training|Patients undergo 16 weeks of physical training
15849354|NCT04047888|Other|Nutrition-based education on infant feeding and practices as well as Non nutrition-based educational message|60 minute educational message at each visit
15849355|NCT04047888|Other|Non nutrition-based educational message|No nutrition-based education on infant feeding and practices
15849356|NCT04047875|Drug|Norethisterone 10mg/day|NET-only pill (Norethisterone, Primolut-Nor®), 10 mg/day, 1 pill per day until 2 consecutive days without bleeding/spotting
15849357|NCT04047875|Drug|Placebo|Identically appearing placebo to Primolut-Nor®, 1 pill per day until 2 consecutive days without bleeding/spotting
15849358|NCT04047862|Drug|BGB-A1217|Administered as an intravenous (IV) injection
15849359|NCT04047862|Drug|Tislelizumab|Administered as an IV injection
15849360|NCT04047862|Drug|Pemetrexed|Administered in accordance with local guidelines, prescribing information/summary of product
15849361|NCT04047862|Drug|Paclitaxel|Administered in accordance with local guidelines , prescribing information/summary of product
15849362|NCT04047862|Drug|Nab paclitaxel|Administered in accordance with local guidelines , prescribing information/summary of product
15849363|NCT04047862|Drug|Carboplatin|Administered in accordance with local guidelines , prescribing information/summary of product
15849364|NCT04047862|Drug|Cisplatin|Administered in accordance with local guidelines , prescribing information/summary of product
15849365|NCT04047862|Drug|Etoposide|Administered in accordance with local guidelines , prescribing information/summary of product
15849366|NCT04047862|Drug|5fluorouracil|Administered in accordance with local guidelines , prescribing information/summary of product
15849367|NCT04047862|Drug|Oxaliplatin|Administered in accordance with local guidelines , prescribing information/summary of product
15849368|NCT04047862|Drug|Capecitabine|Administered in accordance with local guidelines , prescribing information/summary of product
15849369|NCT04047849|Drug|Antibiotics, oral Azithromycin and oral Amoxicillin|Azithromycin (500mg day one followed by 250mg per day for 4 more days) and amoxicillin (500mg orally three times daily for 7 days) for a total course of seven days of antibiotic therapy
15849370|NCT04047836|Other|Low Nicotine E-Liquid|Participants will vape e-liquid with nicotine concentration of 3 mg/ml.
15849371|NCT04047836|Other|Medium or High Nicotine E-Liquid|Participants will vape either e-liquid with nicotine concentration of 18 mg/ml or a JUUL device with JUUL pod of 59 mg/ml nicotine e-liquid.
15849372|NCT04047823|Device|a digital Infrared thermography (FLIR E5 Serial No.63985976）|Measurements were taken during radiation and additionally two weeks after radiotherapy weekly. Temperature change was measured by thermal infrared imager (FLIR) for 4 test areas within the supraclavicular radiation field and on an opposite non-irradiated area, which was outlined using a specific software package (FLIR Systems 6.3.17227.1001).
15849373|NCT04047810|Biological|Mesenchymal Stem Cells|0.5- 2 million cells/kg, intravenously once
15849374|NCT04047797|Drug|Ixazomib|Given by mouth
15849375|NCT04047797|Drug|Ixazomib Citrate|Given by mouth
15849376|NCT04047797|Biological|Rituximab|Given Intravenous
15849377|NCT04047784|Device|Endobronchial ultrasound (EBUS)|"An Olympus EBUS bronchoscope will be used for all endobronchial ultrasound examinations. This scope has a 6.9 mm outer diameter, a 2.7 mm working channel and 30-degree oblique forward-viewing optics. A 12 MHz linear ultrasound transducer with a maximum penetration of 50 mm will be linked to a processor (Olympus EU-ME2) that allows an integrated power Doppler mode to visualize the vascular blood flow.
~Bronchoscopy will be introduced through the adaptor connected to the endotracheal tube, in patients who are already under general anesthesia and on mechanical ventilation. The bronchoscope will be advanced into the airways and endobronchial ultrasound of the main pulmonary artery (PA) and lobar branches will be performed in a standardized fashion. At the completion of the imaging the EBUS bronchoscope will be withdrawn."
15849378|NCT04047771|Drug|SCB-313|Intraperitoneal injection, 3 doses on D1,D4,D7，21 days for 1 cycle
15849379|NCT04047758|Drug|Palbociclib + Letrozole|(1) Palbociclib (trade name: Ibrance®; Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany; imported drug license No. H20180040): 125 mg/capsule, 1 capsule by mouth once a day, for 21 successive days, followed by 7 days off treatment [3 weeks on (days 1-21) and 1 week off (days 22-28)], repeated every 28 days. (2) Letrozole (trade name: Femara®; Novartis Pharma Schweiz AG, Switzerland; imported drug license No. H20140149): 2.5 mg/table, 1 table by mouth once a day, continuously for a 28-day cycle.
15849380|NCT04047758|Drug|Letrozole|Letrozole (trade name: Femara®; Novartis Pharma Schweiz AG, Switzerland; imported drug license No. H20140149): 2.5 mg/table, 1 table by mouth once a day, continuously for a 28-day cycle.
15849381|NCT04047745|Drug|Liposomal bupivacaine|interscalene nerve block administered before surgery using 133 mg liposomal bupivacaine with 10mL 0.5% ropivacaine
15849382|NCT04047745|Drug|Ropivacaine injection|interscale nerve block administered before surgery using 30mL 0.5% ropivacaine
15849383|NCT04047732|Biological|KB105|KB105, a replication-incompetent, non-integrating HSV-1 vector expressing human transglutaminase 1 (TGM1) formulated as a topical gel
15849384|NCT04047719|Diagnostic Test|Karius Test|Karius Test for detection of microbial cell free DNA (mcfDNA) in plasma
15849385|NCT04047706|Biological|IDO1 Inhibitor BMS-986205|Given PO
15849386|NCT04047706|Biological|Nivolumab|Given IV
15849387|NCT04047706|Radiation|Radiation Therapy|Undergo radiation therapy
15849388|NCT04047706|Drug|Temozolomide|Given PO
15849389|NCT04047693|Drug|dose dense MVAC with pegylated GCSF|Methotrexate, 30 mg/m2 IV bolus, Day 1 Vinblastine, 3 mg/m2 IV bolus, Day2 Doxorubicin, 30 mg/m2 IV bolus, Day2 Cisplatin, 70 mg/m2 IV over 1hr, Day2 Pegylated G-CSF, 6mg SC, Day 3 every 2 weeks
15849393|NCT04047680|Drug|Ombitasvir/paritaprevir/ritonavir|Ombitasvir/paritaprevir/ritonavir for 12 weeks
15849394|NCT04047680|Drug|Elbasvir / Grazoprevir Oral Tablet|Elbasvir/grazoprevir for 12 weeks
15849395|NCT04047680|Drug|Glecaprevir and Pibrentasvir|Glecaprevir/pibrentasvir for 12 weeks
15849396|NCT04047667|Procedure|cone beam CT guided transbronchial cryobiopsy|CBCT images are acquried and reviewed in axial, coronal and sagittal planes to most accurately assess the cryoprobe position within the lung parenchyma and relative to other thoracic structures. The minimum probe-to-pleura distance will be measured. If the position of cryoprobe is proper, TBCB will be perfomed.
15849397|NCT04047654|Drug|Non vitamin K oral anticoagulants|Non vitamin K oral anticoagulants are apixaban, dabigatran, rivaroxaban, and edoxaban
15849398|NCT04047641|Drug|Cladribine|Given Intravenous
15849399|NCT04047641|Drug|Cytarabine|Given Intravenous
15849400|NCT04047641|Drug|Idarubicin|Given Intravenous
15849401|NCT04047641|Drug|Quizartinib|Given by mouth
15849404|NCT04047615|Other|Exercise|An exercise intervention programme will be delivered in each school for an 8 week period. Exercise classes will take place 3 times a week and will be of 60 minutes duration.
15849405|NCT04047602|Radiation|Reduced Dose SRS|Subjects will receive SRS treatment at a reduced dose based on the brain tumor size
15849406|NCT04047589|Behavioral|Survey regarding exercise habits, barriers to exercise, and experience with exercise services from the cancer center.|Survey created at Indiana University to gain information regarding exercise habits, barriers to exercise, and experience with exercise services from the cancer center.
15849407|NCT04047589|Behavioral|Survey regarding personal exercise habits and beliefs, barriers to making exercise recommendations|Survey regarding personal exercise habits and beliefs, barriers to making exercise recommendations, and potential resources the cancer center might provide to help make effective exercise recommendations in the future
15849408|NCT04047576|Drug|Sirolimus|The efficacy is evaluated at 12 weeks, and treatment will be adjusted according to the control of disease and adverse effects.For experimental group, if a patient is assessed as treatment failure (TS), the patient should be withdrawn from the study and receive rescue treatment. Whereas, a patient would be transferred to the control group if he/ she cann't stand the side effects of sirolimus but not serious adverse event (SAE).
15849409|NCT04047576|Drug|Corticosteroid|The efficacy is evaluated at 12 weeks, and treatment will be adjusted according to the control of disease and adverse effects. For active comparator group, if a patient is assessed as treatment failure (TF), the patient should be withdrawn from the study and receive rescue treatment.
15849410|NCT04047563|Drug|Normal Saline along with standard treatment|PMZ-1620 (sovateltide) is an endothelin-B receptor agonist. PMZ-1620 has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in cerebral ischemic stroke patients. In this arm normal saline along with standard treatment will be given for active comparison.
15849411|NCT04047563|Drug|PMZ-1620 (sovateltide) along with standard treatment|PMZ-1620 (sovateltide) is an endothelin-B receptor agonist. PMZ-1620 has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in cerebral ischemic stroke patients.
15849412|NCT04047550|Diagnostic Test|Ventilatory chemosensitivity|Using this technique, the patient first voluntarily hyperventilates to a PETCO2 value of 20-25 mmHg, then undergoes a rebreathing test allowing the PCO2 to rise to 55-60 mmHg while PETO2 is maintained at 150 mmHg. The procedure is then repeated with PETO2 clamped at 50 mmHg. Parameters derived from this method include slopes of the ventilatory response during hyperoxia and hypoxia.
15849413|NCT04047537|Other|Medical Food Formulation 1|WBF-0011
15849414|NCT04047537|Other|Medical Food Formulation 2|WBF-0011 (0.2X concentration)
15849415|NCT04047537|Other|Placebo|Placebo Capsules identical to those containing Formulation 1 and 2
15849416|NCT04047524|Other|Monitoring using a FitBit|Each participant will receive a Fitbit. The Prehabilitaiton Group will receive a Fitbit Charge 2 and they will be able to review their progress on this and be required to increase their exercise activity and input information and data about the exercise they have completed each day during their participation in the study. The Control group will receive a Fitbit Flex and will not be required to review any of their activity or input any data and will be encouraged to continue with their daily activity rates i.e. not to change.
15849417|NCT04047511|Device|VRTierOne|"As a virtual reality source, VRTierOne device (Stolgraf®) were used. Thanks to using head mounted display and the phenomenon of total immersion VRTierOne Stolgraf® provides an intense visual, auditory and kinesthetic stimulation. It can have a calming and mood-improving effect or help the patients recognize their psychological resources and motivate to the rehabilitation process. In the virtual therapeutic garden there are a rich set of symbols and metaphors based on Ericksonian Psychotherapy approach. The most important is the Garden of Revival which symbolizes the patient's health. It used to be full of life and energy, now it is neglected, requires work to be revived. In the therapeutic process day by day, the lector (therapist) tells the patient a symbolic story about his/her situation. By performing tasks in the virtual garden, the patient influences the course of this story, becomes an active participant of the therapeutic process and sees the effects his work."
15849570|NCT04046393|Procedure|nasopharyngoscopic examination|use nasopharyngoscopy to determine the modified Lund-Kennedy endoscopic scoring system
15849418|NCT04047511|Behavioral|Group general fitness training|A single session of general fitness training will be composed of low-intensity, general-fitness exercises. Most of the exercises will be carried out in a sitting position and standing positon. The session will contain aerobic (general warm-up), musculo-articular (strengthening muscles and joints range of motion) and stabilizing exercises (improve spatio-visual coordination). Conducted by a physiotherapist in group form.
15849419|NCT04047511|Behavioral|Group Psychoeducation|This section will contain mini-lectures about mental well-being and psychohygiene, conduced by a psychotherapist in group form.
15849420|NCT04047498|Device|Alternating DBS|Constant DBS will be changed to DBS that is up- and downmodulated alternating between the left and right stimulation side.
15849421|NCT04047485|Diagnostic Test|Visual Acuity|During T0, T2 and T3, every subject has been evaluated with a Snellen Chart, to measure visual acuity in number of letters (BVCA)
15849422|NCT04047485|Diagnostic Test|CAM (Confusion Assesment Method)|"During the first 48 hours of post-op follow-up, any episode of post-operative Delirium is checked and evaluated."
15849423|NCT04047485|Diagnostic Test|CATQUEST 9-SF|The questionnaire contains questions evaluating the benefits of cataract surgery. The questionnaire has been used during T0, T2 and T3
15849424|NCT04047485|Diagnostic Test|OCT|Using the RNFL and the Macular Topography protocol, the macula and optical nerve are measured during the T2 phase of each patient the risk of Irvine Gas's syndrome or any other retinal complication.
15849425|NCT04047485|Diagnostic Test|6CIT|This Cognitive Impairment test doesn't require Visual function to be executed. Cognitive function is evaluated at T0, T1 and the post-operative trend at T2 and T3.
15849426|NCT04047485|Diagnostic Test|Barthel Index|To evaluate the everyday independence of the subject and it's trend durin the follow-up
15849427|NCT04047485|Diagnostic Test|Endothelial Microscopy - Cornea|Endothelial cell density is evaluated before surgery (T0) and during the follow-up (T2 and T3). The reason of the choice of this test is to evaluate the trend of these instrumental parameters in the elderly population.
15849428|NCT04047472|Drug|Brolucizumab 6mg|Subjects will receive Brolucizumab 3 x q4w up to Week 8 followed by q12w / q8w up to Week 40 or Week 44, depending on disease activity status.
15849429|NCT04047472|Drug|Aflibercept 2 mg|Subjects will receive Aflibercept 3 x q4w up to Week 8 followed by q8w up to Week 40.
15849430|NCT04047459|Other|Tissue samples collection and cells isolation|During surgery, leftover samples of bone (femoral head/ trabecular bone tissue) and muscle will be collected. Then they will be sent to the laboratory where isolation of cells will be performed.
15849431|NCT04047446|Drug|Exparel 133 MG Per 10 ML Injection|10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total)
15849432|NCT04047446|Drug|Dexamethasone|15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
15849433|NCT04047433|Genetic|screening for single nucleotide polymorphism|samples will be tested for a set of single nucleotide polymorphism
15849434|NCT04047433|Genetic|whole exome sequencing|samples will be tested for identifying specific genetic mutation
15849436|NCT04047407|Device|Suprathreshold pain stimulation|"Suprathreshold pain stimulation will be applied in the infraspinatus muscle (point equidistant between the midpoint of the spine of the scapula, the inferior angle of the scapula and the midpoint of the medial border of the scapula) with a pressure algometer (Force Ten ™, Wagner Instruments, USA). Four suprathreshold pressure stimulations (pressure pain threshold + 20%, +30%, +40% and +50%) will be made for 60 seconds, with a minimum rest of 5 minutes between each stimulation.
~The sequence of stimulation (ascending or descending) will be randomized."
15849437|NCT04047394|Drug|PEGylated recombinant candida urate oxidase|PEGylated recombinant candida urate oxidase is a combination of 20kDa linear polyethylene glycol (PEG) linked to Candida utilis recombinant uricase by succinimide succinate
15849438|NCT04047381|Other|Measurement of Quality of Life|Quality of life will be measured using Atrial Fibrillation Impact Questionnaire, Short Form-36 and Pittsburgh Sleep Quality Index
15849439|NCT04047368|Procedure|Rotablation|Percutaneous Coronary Intervention using Rotablation
15849440|NCT04047368|Procedure|Coronary Lithoplasty|Percutaneous Coronary Intervention using Lithoplasty
15849441|NCT04047355|Drug|Propranolol|Propranolol is a beta-blocker used to treat high blood pressure, irregular heartbeats, and tremors. It is used after a heart attack and to prevent migraine headaches and chest pain. It is also used off-label for anxiety and PTSD.
15849442|NCT04047342|Behavioral|Welcome email|Email
15849443|NCT04047342|Behavioral|Loss frame|Email
15849444|NCT04047329|Other|general anesthesia or neuraxial anesthesia|
15849445|NCT04047316|Device|Digital dermoscopy|Acquire skin images with a new digital dermatoscope
15849446|NCT04047303|Drug|CC-90010|CC-90010
15849447|NCT04047290|Drug|AK112|AK112 is a PD1/VEGF bispecific antibody.
15849448|NCT04047277|Behavioral|Cognitive Behavioral Therapy|The manualized CBT protocol is five sessions that teach sleep hygiene, relaxation strategies, and addresses nightmares therapeutically through exposure and rescripting.
15849449|NCT04047264|Device|Intraoperative cerebral microdialysis using M dialysis 107 pump and 71 High cut-off brain microdialysis catheter|Each microdialysis catheter will be connected to a M dialysis 107 pump, with flow rates between 0.5 and 2 µL per minute. Prior to tumor removal, catheters will be placed within appropriate regions of tumor core or adjacent tissue with assistance of neuronavigation. Any awake or asleep neurophysiological mapping and/or additional localization-guided tissue sampling procedures will be performed while microdialysis is in progress, including cortical or subcortical language or motor mapping. Microdialysis will end when the region being sampled is removed as part of the planned tumor resection. The tissue region sampled by each catheter may be harvested separately for correlative analyses.
15849450|NCT04047251|Drug|FF-10850 Topotecan Liposome Injection|FF-10850 to be diluted and infused over 60 minutes.
15849530|NCT04046614|Drug|nintedanib-nivolumab combination therapy|"Safety run-in - Dose finding stage The safety-run in phase will be designed as a standard 3+3 design for dose escalation/de-escalation and 3 to 6 patients will be enrolled in each cohort sequentially, depending on occurrence of dose limiting toxicities. The recommended phase 2 dose (RP2D) will be the highest dose in which the frequency of DLTs is less than 33% if no other safety or feasibility considerations prevail.
~Expansion phase: Nintedanib RP2D + nivolumab 240 mg Q2W until progression of disease."
15849451|NCT04047238|Other|Reminiscence Therapy|"Intervention group will receive two Reminiscence Therapy sessions per week for 3 months. Reminiscence therapy sessions will last approximately 50 minutes and will be developed according to the following structure:
~Welcome to the patient and reality orientation therapy (7 minutes)
~Conducting the main activity of reminiscence (40 minutes)
~Closure, thank you for the participation and farewell until the next session (3 minutes) Reminiscence therapy sessions will have an individual format and will be conducted by a therapist previously trained in the protocol and the principles of Reminiscence Therapy. The Reminiscence activities of each session will be carried out following the protocol proposed in the Book of Past and Present."
15849452|NCT04047225|Device|THE ANALGESIA NOCICEPTIVE INDEX (ANI)|Utilisation of the ANI during the operation
15849453|NCT04047212|Diagnostic Test|biopsy for oral cancer|surgical biopsy is to be taken for diagnosis of oral cancer or premalignant lesions
15849454|NCT04047212|Diagnostic Test|periodontal examination|Periodontal clinical examination to all by periodontal charting
15849455|NCT04047186|Drug|Nivolumab Injection|Nivolumab 3mg/kg on day-28 and day-14 prior to planned surgical resection
15849456|NCT04047173|Radiation|stereotactic body radiotherapy (SBRT)|Radiotherapy dose is 33-54 Gy, irradiated in 3 times, every other day, completed within 1 week.
15849457|NCT04047173|Procedure|Radiofrequency ablation (RFA)|RFA with a safe margin, RFA again if residual,no more than 2 times.
15849458|NCT04047160|Drug|OP-724|Twice a week for 4 hours continuous intravenous administration of OP-724
15849459|NCT04047147|Other|Enrollment in the Million Hearts CVD Risk Reduction Model|"The intervention is at a provider organization level and all eligible beneficiaries enrolled by participants will be considered exposed. Intervention organizations receive payments to:
~Risk stratify eligible Medicare FFS beneficiaries
~Provide CVD care management to high-risk beneficiaries
~Collect and report clinical data to CMS via the Million Hearts Data Registry and participate in learning system activities
~Participating organizations receive payments for each eligible beneficiary they risk stratify. In model year 1, the organizations receive a fixed payment per beneficiary per month to provide cardiovascular management. In model years 2-5, the organizations receive a risk reduction payment that is scaled based on reductions in 10-year predicted risk scores among their cohort of high-risk beneficiaries."
15849460|NCT04047147|Other|Enrollment in control provider organizations|Control organizations receive payments to collect and report clinical data on their eligible Medicare FFS beneficiaries, but are not asked to calculate CVD risk scores or otherwise change their clinical care.
15849461|NCT04047134|Other|Action Observation Treatrment|Participants will be asked to carefully observe the videos showing different daily actions. Each action will consist of 3 to 4 constituent motor acts. Each motor act will be presented for 3 minutes, totally lasting 12 min/video. At the end of each motor act presentation, participants will be asked to execute with the affected hand the observed motor sequence for 2 minutes (20 minutes/session). 10 daily actions will be recorded. Each video will be presented to participants twice a day, in order to complexity as judged by the experimenter. Only 1 typology of motor task per day for each condition, starting from the easiest and ending with the most complex action throughout 15 sessions spread on 5 weeks (3 sessions/week). Tasks will be based on some relevant activities of daily living belonging to at least one between feeding, self-care or external actions category on the affected side. Each session will last about 15 minutes and will be repeated twice a day, at least 60 minutes apart.
15849462|NCT04047134|Other|Observation of videos with Non Motor contents|Participants will be asked to observe video clips with no specific motor content. Videos will concern scientific, geographical and historical issues. As for cases, video clips will be divided into three to four parts. At the end of each part, controls will execute the same actions as cases, in the same order. In this way cases and controls will undergo the same amount of motor practice and receive the same amount of visual stimulation, the only difference being the content of visual stimuli.
15849463|NCT04047095|Dietary Supplement|Immunonutrients + normal daily meal|"Glutamine Plus by Fresenius Kabi (one sachet composition: glutamine 10 g, carbohydrate 10 g, β-carotene 1.7 mg, vitamin E 83 mg, vitamin C 250 mg, zinc 3.4 mg, selenium 50 μg, and fibre 1.2 g)."
15849464|NCT04047095|Dietary Supplement|Normal daily meal|Normal daily meal (75-80 g protein)
15849465|NCT04047082|Diagnostic Test|Quantitative aortogram (videodensitometry)|Patients that performed TAVR will have their aortogram analysed in the cath-lab by videodensitometry (quantitative aortogram)
15849466|NCT04047069|Behavioral|Awareness Training and Person-Centered Occupational Therapy Intervention|Exp. identifying the activities the person wants to do, suggestions to facilitate the activity, arranging the activity according to the needs of the person, arranging the environment so that the environment can be a facilitating factor in the activities the person wants to do.
15849467|NCT04047069|Behavioral|Awareness Training|"Exp.
~General information about HD
~Approaches to Coping with HD Symptoms
~Self care skills (eg hygiene)"
15849468|NCT04047056|Other|Labor Kinesiotherapy|"The intervention group will perform 5 minutes of warm-up with free active exercises, 10 minutes of specific resistance exercises for the cervical and upper limbs and 5 minutes of stretching and muscle relaxation.The initial free active exercises will be performed in 3 sets of 15 repetitions; Resistance exercises will be performed in 3 sets of 10 repetitions and stretching will be performed in 3 sets of 30 seconds.
~Regarding the intervals between exercises, active recovery will be adopted to counteract the effects of muscle fatigue."
15849469|NCT04047043|Diagnostic Test|serum taurine|blood sample for serum taurine level
15849470|NCT04047030|Other|None- Observational Study|No Intervention
15849471|NCT04047017|Drug|Apatinib|250mg, po, qd
15849472|NCT04047017|Drug|Camrelizumab|200mg, q2w
15849473|NCT04047004|Drug|Doxorubicin|Conventional PIPAC with doxorubicin (2.1 mg/m2 body surface in 50ml saline) is performed through the CE-certified nebulizer by certified PIPAC surgeons directly after the completion of the laparoscopic gastric resection and reconstruction using the remaining relevant ports. Chemotherapy is installed at a rate of 0.5-0.8 ml/s with a maximum pressure of 300 pressure per square inch and 30 minutes of simple diffusion.
15849474|NCT04047004|Drug|Cisplatin|Conventional PIPAC with cisplatin (10.5 mg/m2 body surface in 150ml saline) is performed through the CE-certified nebulizer by certified PIPAC surgeons directly after the completion of the laparoscopic gastric resection and reconstruction using the remaining relevant ports. Chemotherapy is installed at a rate of 0.5-0.8 ml/s with a maximum pressure of 300 pressure per square inch and 30 minutes of simple diffusion.
15849609|NCT04046081|Drug|Dichloroacetate|6.25 mg/kg BD for 6 weeks increasing to 12.5 mg/kg BD for 6 weeks
15849475|NCT04046991|Device|high-definition transcranial direct current stimulation|High definition transcranial direct current stimulation (HD-tDCS) involves the application of low-intensity current through electrodes placed on the scalp. It is believed to elicit brain effects by producing incremental shifts in the resting membrane potential of large numbers of neurons, which alters neuronal firing rates and thus modulates patterns of brain activity in potentially behaviorally-relevant ways. HD-tDCS differs from conventional transcranial direct current stimulation (tDCS) because it employed smaller electrodes configured in such a way as to deliver more focal stimulation of the brain.
15849476|NCT04046991|Behavioral|modified constraint-induced language therapy|Modified constraint-induced language therapy (mCILT) is a behavioral language therapy that invokes use-dependent learning in communicative interactions by requiring spoken output and restricting use of alternative forms of communication, such as gestures, as a substitute for spoken output. Other key elements of CILT include massed practice of goal-directed speech and shaping of desired responses by increasing response demands as participants improve. MCILT differs from traditional constraint-induced language therapy (CILT) in three ways: 1) it will be done as an individual therapy with the examiner in the role of a communication partner; 2) treatment will be delivered in short sessions (1 hour rather than a more typical 3-4 hour session); 3) targeting nouns + semantically related verbs to generate noun + verb phrases in treatment, a modification that may be better suited to addressing syntactic structure.
15849477|NCT04046978|Other|ConM SOSIP 50 ug and ConS UFO 50 ug|Intramuscular injection of synthetic viral immunogens ConM SOSIP and ConS UFO
15849478|NCT04046978|Other|Mos3.1 100 ug|Intramuscular injection of synthetic viral immunogen Mos3.1
15849479|NCT04046978|Other|Mos3.2 100 ug|Intramuscular injection of synthetic viral immunogen Mos3.2
15849480|NCT04046978|Other|Mos3.3 100 ug|Intramuscular injection of synthetic viral immunogen Mos3.3
15849481|NCT04046978|Other|Mos3.1 33 ug, Mos3.2 33 ug and Mos3.3 33 ug|Intramuscular injection of synthetic viral immunogens Mos3.1, Mos3.2 and Mos3.3
15849482|NCT04046952|Device|Statseal with TR Band|Patients will have a Statseal Advance RAD (SS) disc applied after withdrawing the radial sheath 2-4 cm. A Tegaderm dressing will be applied to secure the disc position. The TR band will be applied over the SS disc with the center of the balloon (the green dot) over the center of the SS disc. The TR band will be inflated with 8cc of air (which is typically occlusive pressure), and the sheath removed. No deflation will occur immediately. After 20 minutes of pressure, 3 cc of air will be removed from the TR band. After an additional 40 minutes (60 minutes after procedure), the TR band will be completely deflated.
15849483|NCT04046952|Device|TR band only|Patients will have a TR band applied over the arteriotomy site and inflated with 15-18ml of air. After aspirating and clearing the contents of the sheath, the radial sheath will be removed. The TR band will be deflated until bleeding occurs, and 2 ml of air will be reintroduced to provide hemostasis. Patent hemostasis will be documented with plethysmography and oximetry as described below within 5 minutes after band application and removal, and within 30 min of discharge or after 24 hours. The TR band will be left inflated and in place for 60 minutes following the procedure for all patients (regardless of diagnostic or PCI procedure), after which full deflation attempts will commence.
15849484|NCT04046939|Drug|dexpramipexole 75 mg/day|dexpramipexole low-dose BID
15849485|NCT04046939|Drug|dexpramipexole 150 mg/day|dexpramipexole mid-dose BID
15849486|NCT04046939|Drug|dexpramipexole 300 mg/day|dexpramipexole high-dose BID
15849487|NCT04046939|Drug|placebo oral tablet|placebo BID
15849488|NCT04046913|Behavioral|Dietary education|Intervention: Low food additive diet. Control: Habitual food additive diet
15849489|NCT04046900|Biological|Vaginal microbiome transplant|Vaginal fluid from healthy donors
15849490|NCT04046900|Drug|Oral Metronidazole|500mg oral metronidazole twice daily for 7 days
15849491|NCT04046900|Other|Sterile saline|700 uL of sterile saline placed in the vagina as a placebo intervention.
15849492|NCT04046887|Drug|Lonsurf|Lonsurf will be administered orally twice a day on days 2-6 and 16-20 of every 28-day cycle at a dose of 25 mg/m2, 20 mg/m2 or 30 mg/m2 depending on cohort assignment.
15849493|NCT04046887|Drug|Gemcitabine|Gemcitabine will be intravenously administered on Days 1 and 15 of every 28-day cycle at a dose of 800 mg/m2, 600 mg/m2 or 1000 mg/m2 depending on cohort assignment.
15849494|NCT04046887|Drug|Nab-Paclitaxel|Nab-Paclitaxel will be intravenously administered on Days 1 and 15 of every 28-day cycle at a dose of 100 mg/m2, 75 mg/m2 or 125 mg/m2 depending on cohort assignment.
15849495|NCT04046874|Drug|Usual Care|Pain Medication, imaging, referrals to other health services, other health care appointments
15849496|NCT04046874|Other|SPLIT Stratified Model of Care|Physiotherapy targeted treatment system of increasing complexity for each subgroup (low, medium or high) of risk of chronicity. Includes patient education, manual therapy and exercise
15849497|NCT04046861|Dietary Supplement|ascorbic acid,|The vitamin C group will get high dose of intravenous vitamin C (ascorbic acid) before starting cardiopulmonary bypass, before removing aortic clamp and every 8 hours thereafter for additionaly 24 hours
15849498|NCT04046861|Other|Placebo (saline)|The placebo group will get saline before starting cardiopulmonary bypass, before removing aortic clamp and every 8 hours thereafter for additionaly 24 hours
15849499|NCT04046848|Drug|OCTA101|OCTA101 is composed of OCTA8 (human-cl rhFVIII - Nuwiq Intermediate 2 Q-Eluate) and OCTA12 (recombinant human VWF fragment dimer).
15849500|NCT04046822|Drug|Liraglutide 6 MG/ML [Saxenda]|Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
15849501|NCT04046822|Drug|Placebo|Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
15849531|NCT04046601|Device|impedance|After endoscopic resection of early esophageal cancer, the tissue will be measured by an impedance probe between 10Hz-1000000Hz, 20mV. 8 gold electrodes have been integrated to the probe. The impedance will be measured in different ways between the elctrodes. There will be 10 measurements in total for each specimen.
15849893|NCT04043806|Drug|ELX/TEZ/IVA|Fixed-dose combination (FDC) tablet for oral administration
15849502|NCT04046809|Other|Food for special medical purposes: Neurotidine®|"Each patient will be given the bottles for the first 3-month treatment period by the hospital pharmacist and will be asked to return them at the end of the period (3 months). Then the patients will be given the other bottles for the next phase of the study (3 months): these will contain placebo if the patient received Neurotidine® in the first phase of the study and vice versa. Again, the patients will be asked to return after 3 months with the study bottles and will be given the last set of bottles for the final phase of the study (3 months).
~Administration at a dosage of 10 ml in the morning."
15849503|NCT04046809|Other|Placebo|"Each patient will be given the bottles for the first 3-month treatment period by the hospital pharmacist and will be asked to return them at the end of the period (3 months). Then the patients will be given the other bottles for the next phase of the study (3 months): these will contain placebo if the patient received Neurotidine® in the first phase of the study and vice versa. Again, the patients will be asked to return after 3 months with the study bottles and will be given the last set of bottles for the final phase of the study (3 months).
~Administration at a dosage of 10 ml in the morning."
15849504|NCT04046796|Genetic|NGS Diagnostic|Blood take for genetic diagnostic.
15849505|NCT04046783|Device|patch|an overnight application of a patch containing a standardized quantity of Allium Cepa extract and allantoin on C-section scars over 4 weeks.
15849506|NCT04046770|Device|Drug administration and Flushing procedure using Double-Chamber Syringe|The new device will allow the professional to conduct all the procedure (assure the patency/enables the pre-flushing), drugs administration and flushing, using only one device.
15849507|NCT04046770|Device|Drug administration and Flushing procedure using Classic Syringe|To fully complete the intravenous drug administration with rigor, nurses should flush the catheter pre, post and inbetween drug administration. This implies the use of two or three syringes.
15849508|NCT04046757|Other|Mechanical thrombectomy|Neuroradiological endovascular treatment
15849509|NCT04046744|Procedure|Axillary brachial plexus block with a long-acting local anesthetic|axillary block with 15-30 ml Ropivacaine 0,5%.
15849510|NCT04046744|Procedure|Axillary brachial plexus block with a short-acting local anesthetic + Analgesic block at the elbow with a long-acting local anesthetic|axillary block with 15-30 ml Lidocaine 1,5% + radial and medial nerve block at the elbow with 3-7 ml Ropivacaine 0,5%.
15849511|NCT04046744|Drug|Ropivacaine|axillary block with 15-30 ml Ropivacaine 0,5%
15849512|NCT04046744|Drug|Ropivacaine|radial and medial nerve block at the elbow with 3-7 ml Ropivacaine 0,5%
15849513|NCT04046744|Drug|Lidocaine|axillary block with 15-30 ml Lidocaine 1,5%
15849514|NCT04046731|Diagnostic Test|Skin Testing|Percutaneous skin prick followed by Intradermal Injections of NMBAs at increasing concentrations compared with an established positive and negative control.
15849515|NCT04046718|Device|electro-acupuncture stimulation|stimulation of acupoints of the liver meridian of lv3 lv14
15849516|NCT04046705|Procedure|Allogeneic matched related haematopoietic stem cell transplantation|Allogeneic matched related haematopoietic stem cell transplantation after a reduced intensity conditioning regimen
15849517|NCT04046705|Other|Standard arm|In the standard arm, patients who will not be transplanted, will receive the best standard care according to their situation and their previous treatment: initiation of hydroxyurea, continuation or optimization of the dose of hydroxyurea, initiation or continuation of transfusion program, initiation of a new drug proved to improve SCD and having authorization to use in France
15849518|NCT04046692|Other|Hospital School Experience, point of view of the children|Operators of the PANAS-C, PH-C and VAS ask the children to answer the questionnaire before/after the school lesson; then they ask the children to make 2 paintings about hospital and not hospital school experience.
15849519|NCT04046692|Other|Hospital School Experience, point of view of the hospital teachers|operators interview hospital teachers and make them complete a questionnaire (CEESQ)
15849520|NCT04046692|Other|Hospital School Experience, point of view of the non hospital teachers|operators interview the teachers and make them complete a questionnaire (CEESQ)
15849521|NCT04046692|Other|Hospital School Experience, point of view of parents|Operators interview parents
15849522|NCT04046679|Drug|Bleomycin|Skin bleomycin infusion through tattoo machine
15849523|NCT04046679|Other|Saline Solution|Saline solution infusion through tattoo machine
15849524|NCT04046666|Device|Functional near infrared spectroscopy|Functional near infrared spectroscopy will be adopted to assess the metabolic characteristics of the Heart and Lung meridians. The probes will be left at 4 measurement sites, which include Shenmen (HT7) and Shaohai (HT3) of the Heart meridian, Taiyuan (LU9) and Chize (LU5) of the Lung meridian.
15849525|NCT04046666|Procedure|Moxibustion|"Two sessions of moxibustion will be performed in the Heart meridian and Lung meridian successively.
~Intervention in the Heart meridian: moxibustion will be performed above Shaohai (HT3) for 15 minutes. During moxibustion, the probes of near infrared spectroscopy will detect the metabolic characteristics of three measuring sites, which include the midpoint of the Heart meridian along the forearm, Chize (LU5) of the Lung meridian, and the midpoint of the Lung meridian along the forearm.
~Intervention in the Lung meridian: moxibustion will be performed above Chize (LU5) for 15 minutes. During moxibustion, the probes of near infrared spectroscopy will detect the metabolic characteristics of three measuring sites, which include the midpoint of the Lung meridian along the left forearm, Shaohai (HT3) of the Heart meridian, and the midpoint of the Heart meridian along the forearm."
15849526|NCT04046653|Dietary Supplement|Allin|Dietary supplement
15849527|NCT04046653|Dietary Supplement|Sulforaphane|Dietary supplement
15849528|NCT04046653|Dietary Supplement|Placebo|Dietary supplement
15849529|NCT04046640|Device|Infrared thermal imaging|"Infrared thermal imaging will be adopted to assess the heat transport characteristics of meridian phenomenon for participants in the two groups.
~Experimental device: a NEC InfRec R450 infrared thermal imaging camera
~Experimental process: The participants will be allowed to stabilize for 15 minutes in a supine position in the experimental room before formal examination They are asked to keep silent, breathe normally and avoid movement of limbs during the whole measuring period. The height and angle of the infrared thermal imaging camera is adjusted so that the measurement sites of the participant's arm is located in the center of the camera screen. The infrared thermal imaging and acupoint temperature will be recorded for 5 minutes.
~Measurement sites: Shenmen (HT7) and Shaohai (HT3) of the Heart meridian, Taiyuan(LU9) and Chize (LU5) of the Lung meridian."
15849894|NCT04043806|Drug|IVA|150-mg tablet for oral administration
15849532|NCT04046588|Diagnostic Test|Infrared thermography|A thermal imager (NEC InfRec R450, Avio Infrared Technologies Co., Ltd., Tokyo) will be used to record thermal images. The temperature of corresponding sites on the Heart and Lung meridians will be analyzed.
15849533|NCT04046588|Procedure|Moxibustion|"Two sessions of moxibustion intervention will be performed in the Heart meridian and Lung meridian, respectivey. During moxibustion, the temperature change of relevant sites in the Heart and Lung meridians will be measured by infrared thermal imaging.
~Intervention in the Heart meridian: moxibustion will be performed above the acupoint HT3 of the Heart meridian
~Intervention in the Lung meridian: moxibustion will be performed above the acupoint LU5 of the Lung meridian."
15849534|NCT04046575|Radiation|Intensity Modulated Radiation Therapy|-15 fractions of treatment
15849535|NCT04046575|Drug|Carboplatin|Begins on day 1 of radiotherapy
15849536|NCT04046575|Other|MD Anderson Symptom Inventory (MDASI)-Plus module|The QOL questionnaires will be answered by the patients prior to the start of chemoradiation, on the last week of RT, and at 6-8 week follow-up, 3, 6, 9, and 12 months post completion of RT
15849537|NCT04046575|Other|EuroQol (EQ-5D)|The QOL questionnaires will be answered by the patients prior to the start of chemoradiation, on the last week of RT, and at 6-8 week follow-up, 3, 6, 9, and 12 months post completion of RT
15849538|NCT04046575|Other|SF-12|The QOL questionnaires will be answered by the patients prior to the start of chemoradiation, on the last week of RT, and at 6-8 week follow-up, 3, 6, 9, and 12 months post completion of RT
15849539|NCT04046575|Other|MOS Social Support Measure|The QOL questionnaires will be answered by the patients prior to the start of chemoradiation, on the last week of RT, and at 6-8 week follow-up, 3, 6, 9, and 12 months post completion of RT
15849540|NCT04046575|Other|CES-D|The QOL questionnaires will be answered by the patients prior to the start of chemoradiation, on the last week of RT, and at 6-8 week follow-up, 3, 6, 9, and 12 months post completion of RT
15849541|NCT04046575|Procedure|Blood for ctDNA (optional)|-Collected at pre-treatment, every 2 weeks during chemoradiation, every 2-3 weeks during consolidation chemotherapy, completion of therapy, 6-8 week follow-up, 3 month follow-up, 6 month follow-up, and 12 month follow-up
15849542|NCT04046575|Procedure|Blood for SCCA|-Collected at pre-treatment, completion of therapy, and 6 month follow-up
15849543|NCT04046575|Drug|Paclitaxel|Begins on day 1 of radiotherapy
15849544|NCT04046562|Behavioral|PAW|Pain and Weight Treatment plus standard of care
15849545|NCT04046562|Behavioral|Pain Education|Pain Education plus standard of care
15849546|NCT04046549|Drug|Belatacept|Belatacept Dose 1 will be administered intravenously on post-op Day 1, repeated on post-op Day 3 or 4, and at the end of Weeks 2, 4, 8 and 12; then Dose 2 every four weeks from Week 16 to Week 48.
15849547|NCT04046549|Drug|VIB4920|VIB4920 Dose 1 will be administered intravenously on post-op Days 1, and 14, and at the end of Weeks 4, 6, 8 and 10; then will continue every four weeks from Week 12 to Week 48.
15849548|NCT04046536|Device|Transcranial Magnetic Stimulation|A non-invasive treatment that emits magnetic pulses to stimulate the brain.
15849549|NCT04046536|Device|Sham Transcranial Magnetic Stimulation|Sham rTMS will consist of the same parameters as active, however, the subject will not receive the actual magnetic stimulation due to the use of a double sided Active/Sham coil used specifically for research studies.
15849550|NCT04046523|Device|Video ophthalmoscope|Use of a custom video ophthalmoscope with either a CCD or CMOS camera lens. The healthy controls group (first 20 subjects) will provide data to help determine which lens might be best for measuring ICP patients (Groups A and B) in the second phase of the study.
15849551|NCT04046510|Drug|Ocytocin|Administration of lower doses of Ocytocin in bolus and continuous infusion
15849552|NCT04046497|Other|Smartphone App|artificial intelligence (AI) smartphone app to provide support for medication adherence
15849553|NCT04046497|Other|Usual Care|Usual Care provided by CSC clinic
15849554|NCT04046484|Drug|Normal Saline along with standard treatment|The arm is for active comparison for PMZ-1620 (sovateltide), an endothelin-B receptor agonist. PMZ-1620 has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in cerebral ischemic stroke patients. Normal saline (vehicle) with standard treatment will be provided.
15849555|NCT04046484|Drug|PMZ-1620 along with standard treatment|PMZ-1620 (sovateltide) is an endothelin-B receptor agonist. PMZ-1620 has the potential to be a first-in-class neuronal progenitor cell therapeutics that is likely to promote quicker recovery and improve neurological outcome in cerebral ischemic stroke patients.
15849556|NCT04046471|Dietary Supplement|enhanced Stop Light Diet|Stop light diet enhanced with portion-controlled meals
15849557|NCT04046471|Behavioral|Group Remote|Participants will receive remotely delivered weight loss in a group setting.
15849558|NCT04046471|Behavioral|Individual In-Person|Participants will receive a weight loss intervention during individual, at-home visits.
15849559|NCT04046458|Behavioral|Nighttime Vital Sign EHR Alert|A pop-up window in the EHR will notify a physician that their patient has been judged by a predictive algorithm to be safe for reduced overnight vital sign checks.
15849560|NCT04046458|Other|No EHR alert|No change to EHR function; no alert visible to providers
15849563|NCT04046432|Dietary Supplement|Vigiis 101-LAB|examined the effects of the Vigiis 101-LAB capsules I or II (5 or 10 billion CFU/day)
15849564|NCT04046432|Dietary Supplement|Placebo|Maltodextrin was used as a placebo.
15849565|NCT04046419|Other|Turkish validity and reliability|"Explanation of the Turkish version of the scale.
~Translating the Turkish version of the scale into English to ensure consistency with the original scale.
~First application of scales to participants.
~Second application of the scales to the participants.
~Statistical analysis and scaling"
15849566|NCT04046406|Device|MR neurography-guided cryoanalgesia|Treatment will be performed using a FDA-approved Galil Medical cryoablation system and FDA-approved Galil Medical cryoablation needles.
15849567|NCT04046393|Device|"Taiwan Scientific noninvasive blood pressure meter TS-0411"|measure autonomic nerve
15849568|NCT04046393|Device|Meridian Energy Analysis Device(MEAD)|measure meridian energy
15849569|NCT04046393|Procedure|bacteria culture|use culture swab to culture nasal discharge
15849666|NCT04045626|Procedure|corneal cross-linking|Riboflavin is instilled over cornea followed by Ultraviolet-A irradiation
15849571|NCT04046393|Combination Product|TCM nasal irrigation|Chinese herbal medicine (licorice) extract solution with buffered salt packet and water in rinse bottle
15849572|NCT04046380|Diagnostic Test|work of breath measurement and calculation|The ventilator-imposed power at various tidal volume (6, 8, 10 ml/Kg) and positive end-expiratory pressure (5, 10 cmH 2 O) will be calculated by the formula.
15849573|NCT04046367|Behavioral|Prehabilitation|Prehabilitation: The intervention of a physiotherapist will be added to the components of the control group. Patients will receive practical instructions on aerobic and resistance physical activity, as well as training of their inspiratory muscles.
15849574|NCT04046367|Behavioral|Control|Standard group intervention. Educational program and cognitive-behavioral intervention. The patient receives training in nutrition and cognitive-behavioral therapy, as well as standard instructions to increase physical activity.
15849575|NCT04046354|Device|Ultrasound-guided Percutaneous Microwave Ablation|Ultrasound-guided Percutaneous Microwave Ablation
15849576|NCT04046354|Device|Ultrasound-guided Percutaneous Radiofrequency Ablation|Ultrasound-guided Percutaneous Radiofrequency Ablation
15849577|NCT04046341|Behavioral|Sleep Well!|The intervention comprehensively addresses poor sleep health behaviors (e.g., use of electronics at bedtime; inconsistent and variable sleep schedules; lack of a bedtime routine) as well as insomnia (difficulty falling and staying asleep; the need for caregiver presence at bedtime) and insufficient sleep in toddlers and preschoolers. Interventionists will use strategies to engage with and empower families, such as motivational interviewing and collaborative problem-solving. Session content will be reinforced via phone calls from interventionists. Families will receive intervention session appointment reminders and information about intervention content (e.g., reminders to follow a bedtime routine) via text message.
15849578|NCT04046328|Drug|Enteric-Coated Cholestyramine (ECC) Capsule|Enteric-Coated Delayed Release Cholestyramine Capsules
15849579|NCT04046328|Drug|Placebo|Enteric-Coated Delayed Release Placebo Capsules
15849580|NCT04046315|Diagnostic Test|CMR|GLS measurement with CMR
15849581|NCT04046302|Drug|Dinoprostone|1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) self-inserted by participants 3 hours before scheduled IUD insertion appointment.
15849582|NCT04046302|Drug|placebo|one tablet of placebo self-inserted by participants 3 hours before scheduled IUD insertion appointment.
15849583|NCT04046289|Dietary Supplement|Low Calcium Milk|50 mg calcium/day
15849584|NCT04046289|Dietary Supplement|Regular Calcium Milk|400 mg/day
15849585|NCT04046289|Dietary Supplement|Probiotic 1|regular calcium milk + probiotic
15849586|NCT04046289|Dietary Supplement|Probiotic 2|regular calcium milk + probiotic
15849587|NCT04046276|Behavioral|High Intensity Aerobic program|Three sessions a week of hospital-based exercise on a stationary bicycle, all in presence and with the guidance of a physical education teacher, for nine months
15849588|NCT04046276|Other|Conventional Physical Therapy|Three sessions a week of hospital-based exercise on a stationary bicycle, all in presence and with the guidance of a physical education teacher, for nine months
15849589|NCT04046276|Behavioral|Medium Intensity Aerobic program|Three sessions a week of hospital-based exercise on a stationary bicycle, all in presence and with the guidance of a physical education teacher, for nine months
15849590|NCT04046263|Drug|Sucroferric Oxyhydroxide Chewable Tablet|Patients will be started on 1 tablet three times daily with meals and the dose will be titrated monthly in increments of 500mg (1 tablet) per day until serum phosphate is at goal
15849591|NCT04046250|Drug|TK-112690|TK112690 treatment pre-methotrexate treatment
15849592|NCT04046250|Drug|Placebo TK-112690|Placebo
15849593|NCT04046237|Other|Periodontal treatment|"Periodontal treatment can last up to 6 months depending on the periodontal state, followed by a follow-up period of at least 6 months including a visit to M9.
~Briefly, the intervention group includes initial therapy in 48 hours maximum which includes information on oral hygiene techniques (verbal + brochure), scaling and surfacing of dental roots with antiseptic irrigation and non-tooth extraction. retainable. This initial therapy is followed by a resumption of periodontal clinical measures after 6 weeks. Depending on the degree of improvement of the measurements, the treatment is either completed, or continues with further scaling-surfacing and / or performing one or more periodontal surgeries. Periodontal monitoring period often called maintenance includes repeated sessions of simple scaling whose rate does not exceed 4 per year."
15849594|NCT04046224|Biological|ST-920|Single dose of investigational product ST-920
15849595|NCT04046211|Drug|Hydrogen|Gas exposure for 24, 48 or 72 hours via high flow nasal cannula.
15849596|NCT04046198|Other|Educational program|The Professional Values Education Program was developed in accordance with the Professional Values Model. For nurses in the intervention group program continued for three months. Group training was given before. Then, three individual interviews were conducted. After the post test was applied to the control group, group training was performed.
15849597|NCT04046185|Drug|PD-1 inhibitor combined progesterone|Toripalimab combine with progesterone
15849598|NCT04046185|Drug|progesterone|progesterone
15849599|NCT04046172|Procedure|supra/sub gingival root surface debridement|The test group will undergo Intensive periodontal treatment (IPT)
15849600|NCT04046172|Procedure|supra-gingival scaling and polishing|Control group will receive the Control periodontal treatment (CPT).
15849601|NCT04046159|Drug|Low-dose tamoxifen|Low-dose tamoxifen is not inferior than radiotherapy in decreasing ipsilateral breast tumor recurrence and side effect
15849602|NCT04046159|Radiation|Whole breast radiotherapy|Ipsilateral breast tumor recurrence and side effect
15849603|NCT04046146|Drug|Indocyanine Green|A trained physician will inject 0.1 ml of Indocyanine Green into the web spaces of the hands in both upper extremities. Subjects may have up to five study visits to confirm feasibility, safety, and reproducibility.
15849604|NCT04046146|Device|MultiSpectral Imaging System|Once the Indocyanine Green is injected, the contrast is expected to fluoresce underneath the MultiSpectral Imaging System. Multispectral video and still images will be recorded at the study visits.
15849605|NCT04046133|Drug|Pembrolizumab|Pembrolizumab, an immune checkpoint inhibitor, concomitantly with standard CRT in patients with locally advanced T3/4 anal cancer.
15849606|NCT04046120|Other|Heel-free bandage|The bandage is made by leaving the heel uncovered.
15849607|NCT04046107|Biological|Cemiplimab|Administered as an intravenous (IV) infusion
15849608|NCT04046094|Drug|Ascorbic Acid|Ascorbic Acid Intravenous
15849610|NCT04046068|Procedure|ComfortSafe Care|In most cases, sevoflurane, an inhalation anesthetic, will be used in higher-than-traditional concentrations to replace opioids and provide safe control of vital signs along with amnesia and analgesia. Intravenous (IV) propofol, esmolol, and other beta-blockers can also be administered to prevent increases in BP and HR during surgery. At the time of wound closure, the ComfortSafe Pyramid derived Preemergence Analgesic Checklist guides the anesthesia and surgical teams through collaborative decisions for implementation of a multimodal analgesic plan. Local anesthetics, including liposomal bupivacaine, can then be injected and IV non-opioid analgesics administered allowing the patient to awaken comfortably from anesthesia. Standardized kits for liposomal bupivacaine administration will be utilized. If the patient does have pain, IV opioids can be administered to provide immediate relief without hesitation since the non-opioid analgesics have already been given.
15849611|NCT04046055|Device|Transcranial direct current stimulation at 2 mA|Uses weak electrical current (2 mA intensity) to either increase or decrease brain excitability and improve functional or cognitive outcomes.
15849612|NCT04046055|Device|Transcranial direct current stimulation at 4 mA|Uses weak electrical current (4 mA intensity) to either increase or decrease brain excitability and improve functional or cognitive outcomes.
15849613|NCT04046055|Device|Sham transcranial direct current stimulation|Uses weak electrical current (2 mA intensity) at the beginning and the end of a given stimulation period to control for potential placebo-like effects or participant expectation bias.
15849614|NCT04046042|Other|Conventional exercise|Virtual reality exercise performed during the first two hours of the hemodialysis session
15849615|NCT04046042|Other|Exercise during the last two hours of the hemodialysis session|Virtual reality exercise performed during the last two hours of the hemodialysis session
15849616|NCT04046029|Drug|Bivalirudin|Bivalirudin will be given as a bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg/h during the PCI procedure and for at least 30 minutes but no more than 4 hours afterwards. Following this mandatory infusion,a reduced-dose infusion (0.2 mg/kg/h) for up to 20 hours could be administered at physician discretion. An additional bivalirudin bolus of 0.3 mg/kg was given if the activated clotting time 5 minutes after the initial bolus was less than 225 seconds.
15849617|NCT04046029|Drug|Heparin|Heparin will be administered at a dose of 70 to 100 units per kilogram in patients not receiving glycoprotein IIb/IIIa inhibitors and at a dose of 50 to 70 units per kilogram in patients receiving glycoprotein IIb/IIIa inhibitors. Subsequent adjustment of the heparin dose on the basis of the activated clotting time will be left to the discretion of the treating physicians.
15849618|NCT04046016|Drug|Paclitaxel|Liporaxel and microdose 18F-Liporaxel administration study was conducted in two breast cancer patients. Therapeutic dose of Liporaxel was 200 mg/m2 and 18F-Liporaxel was 0.98-2.9 μg (185-555 MBq).
15849619|NCT04046003|Behavioral|Tai chi exercise|24-form Yang style Tai Chi (60 min/session, 3 sessions/week) for 8 weeks
15849620|NCT04045990|Device|repetitive transcranial magnetic stimulation (rTMS)|rTMS is a method to focally and reversibly stimulate a pre-specified cortical target. rTMS works through the principle of electromagnetic induction.
15849621|NCT04045977|Behavioral|Cardiac rehabilitation|Four weeks of cardiac rehabilitation conducted in an outpatient care facility. Three times per week (80 minutes per day) cardiologically monitored aerobic training consisting of: 40 minutes of interval training on a cycloergometer and 40 minutes of general fitness exercises.
15849622|NCT04045977|Device|Virtual therapeutic support|"8 sessions of VR therapy (each of them 20 minutes long).
~As a virtual reality source, VR Tier One device (Stolgraf®) were used. Thanks to using head mounted display and the phenomenon of total immersion VR therapy provides an intense visual, auditory and kinesthetic stimulation. It can have a calming and mood-improving effect or help the patients recognize their psychological resources and motivate to the rehabilitation process. In the virtual therapeutic garden there are a rich set of symbols and metaphors based on Ericksonian Psychotherapy approach. The most important is the Garden of Revival which symbolizes the patient's health. It used to be full of life and energy, now it is neglected, requires work to be revived. In the therapeutic process day by day, the therapist tells the patient a symbolic story about his/her situation. By performing tasks in the virtual garden, the patient becomes an active participant of the therapeutic process and sees the effects his/her work."
15849623|NCT04045977|Behavioral|Standard therapeutic support|8 sessions of Schultz Autogenic Training (each of them 20 minutes long).
15849624|NCT04045964|Drug|nicotine replacement therapy (NRT)|Participants were provided with either 2 weeks of 14-mg or 21-mg transdermal nicotine patches for every smoker in the home
15849625|NCT04045964|Behavioral|motivational advice|Received two in-hospital motivational advice sessions by a research associate (RA). The RA adapted session content from a previous tobacco-smoke exposure protocol
15849626|NCT04045964|Behavioral|Quitline referral|Quitline participants received information about tobacco-smoke exposure reduction and a referral to a tobacco Quitline.
15849627|NCT04045951|Other|Myopia prediction algorithm|Candidate predictors included age at examination, SER, and annual progression rate. Using these predictors, the algorithm will be used to predict SER at 3 years.
15849628|NCT04045938|Other|Low Glycemic Index or Glycemic Load|Dietary pattern focused on low glycemic index foods or on a low glycemic load
15849629|NCT04045925|Other|Taïso|Taiso is a physical preparation practice of which the French Judo Federation is a state delegate. It is practiced in most French dojos. During each course, Taiso's practice works the fundamental motor skills (coordination, static and dynamic balance, locomotion and grip), muscle strengthening, target work by simulated attacks-defenses exercises without blows or projections, relaxation and the specific work of knowledge to fall and rise with graduation and progressivity in the intensity and complexity of the exercises as and when practiced.
15849630|NCT04045912|Other|AGYW-Friendly Services|"Drug shops will offer a loyalty program (the Queen Club) through which AGYW can earn mystery prizes and discretely request free SRH products. Drug shops will also have an SRH product display and a tablet with SRH videos for interested customers, and drug shop employees will receive training on contraceptive counseling for AGYW."
15849631|NCT04045912|Other|HIVST|Drug shops will provide HIVST kits to AGYW for free. Employees will receive training on HIVST and will institute an HIV care referral plan for customers who require linkage to confirmatory testing or treatment.
15849632|NCT04045899|Device|Proseal LMA|The Proseal Laryngeal Mask Airway (p-LMA) has a dual cuff modified to provide better sealing, and a drainage tube for gastric tube insertion. These features attribute in increasing the safety of the p-LMA when used with positive pressure ventilation.
15849633|NCT04045899|Device|Air-Q LMA|Air-Q LMA has a self-pressurizing cuff which inflates to adequate pressure during positive pressure ventilation thus eliminating the adverse effects of cuff over inflation associated with the use of Supraglottic airway device with an inflatable cuff.
15849634|NCT04045899|Device|Ambu AuraGain LMA|The AmbuAuraGain™ is a disposable, preformed second generation SAD, anatomically curved with integrated gastric access and intubation capability, taking patient safety and airway management efficiency to a new level.
15849635|NCT04045886|Behavioral|Online Educational Modules (Videos)|5 educational online modules (videos) about DNR/goals of care discussions that the participant will watch as part of the intervention. This is the only intervention.
15849636|NCT04045873|Device|extracorporeal membrane oxygenation|The VA-ECMO procedure will be performed by femoral artery access, and the IABP will then be implanted in the contralateral femoral artery.
15849637|NCT04045860|Procedure|Complete Decongestive Therapy|A combination of manual lymph drainage , compression bandaging, physical exercise and a skin care regimen
15849638|NCT04045860|Other|Observation|Standard of care is currently observation
15849639|NCT04045847|Biological|CD147-CART|Three doses of CD147-CART cells were injection to intracavity by Ommaya Reservoir.
15849640|NCT04045834|Device|68Ga-DOTA-TATE PET/MR and PET/CT imaging|Intravenous access is established in advance, intravenous bolus injection, 68Ga-DOTA-TATE dose is about 2 MBq/kg body weight (0.054 mCi/kg) up to 200 MBq (5.4 mCi), 18F-FDG dose is about 3.7-5.4 MBq/kg (0.1 -0.15 mCi/kg), rinsed with 0.9% saline, and hydrated after drinking more water.
15849641|NCT04045821|Drug|AMD3100|Subjects in this arm will have AMD3100 administered per the standard dosing regimen of 0.24 mg/kg actual body weight subcutaneous x1 dose
15849642|NCT04045821|Drug|Normal saline|Subjects in this arm will have a placebo of normal saline administered subcutaneously x1 dose
15849643|NCT04045821|Procedure|dilation and curettage|all participants will undergo routine D&C procedure
15849644|NCT04045808|Other|radiographic evaluations were done|For radiographic analysis, periapical radiographs were taken from teeth with ≥ 4mm PPD using a hand held intra-oral x-ray system operating at 60kVp, 1.5 mA . The alveolar bone loss was measured by a personal computer with the Microsoft Windows XP operating system with original software.
15849645|NCT04045795|Drug|isatuximab SAR650984|Pharmaceutical form: solution Route of administration: intravenous
15849646|NCT04045795|Drug|pomalidomide|Pharmaceutical form: tablet Route of administration: oral
15849647|NCT04045795|Drug|dexamethasone|Pharmaceutical form: tablet Route of administration: oral
15849648|NCT04045795|Drug|isatuximab SAR650984|Pharmaceutical form: solution Route of administration: subcutaneous
15849649|NCT04045782|Drug|single arm|switch from originator (Humira) to biosimilar (Imraldi)
15849650|NCT04045769|Drug|Saroglitazar magnesium 4mg|1 tablet of 4 mg Saroglitazar magnesium; 4 tablets of placebo to be administered orally
15849651|NCT04045769|Drug|Placebos|5 tablets of placebo to be administered orally
15849652|NCT04045769|Drug|Moxifloxacin 400mg|1 tablet of 400 mg Moxifloxacin to be administered orally
15849653|NCT04045769|Drug|Saroglitazar magnesium 20 mg|5 tablets of 4 mg Saroglitazar magnesium to be administered orally
15849654|NCT04045756|Device|Procedure/Surgery: Transperineal Focal Laser Ablation (TPLA)|The intervention will take place in an ambulatory setting of the interventional radiology department using the combined Echolaser XVG system. The treatment consists of a local anesthesia to the perineal region. Within each needle, an optic fiber of 300um will be inserted. Each ablation lasts 6 minutes and each fiber ablates 1800J at a power of 2-3W. At the end of the ablation there is a pull-back of about 1cm from the original ablation location. According to the dimension of the middle lobe of the prostate, multiple pullbacks can be used. The total ablation is 3600J for 2 fibers (1800J/ fiber) at the power of 2-3W for a total duration of about 30minutes. At the end of the treatment, a 20mg bollous of i.v. corticosteriods () is given for anti-edema and anti-inflammatory effects. Antibiotic therapy (Cirpofloxacin 500mg and gastroprotective therapy is given for 5 days. After an adequate amount of time for observation, the patient is dismissed.
15849655|NCT04045743|Drug|MABp1 (Bermekimab) OR Placebo|Period A: patients randomized 1:1 to weekly subcutaneous treatment with 400mg Bermekimab or matched Placebo for 12 weeks
15849656|NCT04045743|Drug|MABp1 (Bermekimab)|Period B: all patients treated weekly with subcutaneous 400mg Bermekimab for 12 weeks
15849657|NCT04045730|Drug|Gemcitabine|All patients will receive treatment with gemcitabine, nab-paclitaxel, PVHA, and pembrolizumab.
15849658|NCT04045717|Radiation|Hypo-FLAME 2.0 study|SBRT technique with 35 Gy in 5 fractions to the whole prostate gland and an additional simultaneously integrated focal boost to the tumor nodule(s) visible on MRI up to 50 Gy (overall treatment time (OTT) = 15 days).
15849659|NCT04045704|Procedure|Cataract Surgery|Patients with bilateral Advanced Age-related macular degeneration and concurrent cataracts will be receiving bilateral cataract surgery
15849660|NCT04045691|Drug|Encorafenib|Observation of real-life treatment with encorafenib and binimetinib
15849661|NCT04045691|Drug|Binimetinib|Observation of real-life treatment with encorafenib and binimetinib
15849662|NCT04045678|Drug|LY03003 ( Rotigotine, extended-release microspheres)|"Patients to be enrolled to 70 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week,56 mg in the fourth week and then 70 mg in the next 5 weeks.
~Patients to be enrolled to 84 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week,56 mg in the fourth week, 70mg in the fifth week and then 84 mg in the next 5 weeks."
15849663|NCT04045678|Drug|Placebo, extended-release microspheres|"Patients to be enrolled to 70 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week,56 mg in the fourth week and then 70 mg in the next 5 weeks.
~Patients to be enrolled to 84 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week,56 mg in the fourth week, 70mg in the fifth week and then 84 mg in the next 5 weeks."
15849664|NCT04045665|Drug|Antiplatelet-only strategy|Aspirin 75-325 mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)
15849665|NCT04045665|Drug|Oral Anticoagulant plus background antiplatelet therapy|OAC with vitamin K antagonist (VKA) with international normalized ratio (INR) target 2-3 or any approved direct oral anticoagulant OR apixaban, rivaroxaban, edoxaban or dabigatran) in addition to background antiplatelet therapy with aspirin 75-325mg once-daily or a P2Y12-inhibitor (clopidogrel or ticagrelor)
15849667|NCT04045613|Drug|Derazantinib dose level 1 (300mg once daily) monotherapy|Derazantinib will be administered orally at a dose of 300 mg once per day.
15849668|NCT04045613|Drug|Derazantinib various dose levels in combination with atezolizumab|Derazantinib was administered orally at various dose levels and the RP2D of derazantinib in combination with atezolizumab was determined to be 300 mg once per day derazantinib plus 1200 mg atezolizumab every three weeks.
15849669|NCT04045613|Drug|Derazantinib dose level 2 (200 mg twice daily) monotherapy|Derazantinib will be administered orally at a dose of 200 mg twice daily.
15849670|NCT04045613|Drug|Derazantinib dose level 1 in combination with atezolizumab|Derazantinib will be administered orally at a dose of 300 mg once per day in combination with atezolizumab 1200 mg every three weeks.
15849671|NCT04045613|Drug|Derazantinib dose level 2 in combination with atezolizumab|Derazantinib will be administered orally at a dose of 200 mg twice daily in combination with atezolizumab 1200 mg every three weeks.
15849672|NCT04045600|Behavioral|Trad FCT|This intervention emulates a traditional reinforcement schedule-thinning method during FCT in which clinicians program delays to reinforcement without discriminative stimuli (e.g., the child learns that some FCRs result in reinforcement and some do not). By programming reinforcement approximately every 15 s, the rate of reinforcement will be equivalent to mult FCT. During Period 1 of this project, trad FCT served as an appropriate control condition to which mult FCT could be compared.
15849673|NCT04045600|Behavioral|Mult FCT|This intervention involves correlating discriminative stimuli (e.g., purple and yellow index cards) with times in which reinforcement for the functional communication response (FCR) is and is not available. During Period 1 of this project, this procedure resulted in rapid reduction of destructive behavior and mitigated resurgence and renewal when the discriminative stimuli were used as programmed.
15849674|NCT04045600|Behavioral|Mult FCT + Stimulus Fading|This condition is similar to mult FCT except that the experimenters will gradually incorporate natural stimuli (e.g., rugs, tables, lamps) into sessions to approximate target settings that may occasion relapse typically without such gradual stimulus fading.
15849675|NCT04045574|Procedure|The 1T1T concept versus conventional implant loading protocol|Implant placement followed by either a conventional or a delayed loading of a PICN screw-retained crown.
15849676|NCT04045548|Drug|Dinoprostone|1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the study nurse 6 hours before IUD insertion.
15849677|NCT04045548|Drug|Placebo|one tablet of placebo inserted by the study nurse 6 hours before IUD insertion.
15849678|NCT04045535|Other|Physical Activity Program|Usual Care and a nurse-led physical activity program once a week for 8 weeks. Each session last for 60 minutes, 15 for warming-up and 45 for different exercises.
15849679|NCT04045535|Other|Usual care|Usual clinical care based on current clinical practice guidelines.
15849680|NCT04045522|Drug|Zoledronic Acid|Based on routine treatment, 4 mg zoledronic acid (Novartis Pharma Stein AG, Switzerland, registration No. H20140218) was intravenously administered, once every 3-4 weeks, for 1-2 years.
15849681|NCT04045509|Device|Liquid Jet Esthesiometer Prototype|Balanced salt solution with a pH value similar to the tear film uesd as a liquid jet stimulus for corneal sensation threshold measurement
15849682|NCT04045509|Device|Tactile Esthesiometer Prototype|A round plastic nozzle (1.8mm diameter) used as a stimulus for corneal sensation threshold measurement
15849683|NCT04045509|Device|Cochet Bonnet esthesiometer|A nylon thread (0.12mm diameter) used as a stimulus for corneal sensation threshold measurement
15849684|NCT04045496|Drug|JAB-3312|JAB-3312 will be supplied as 0.25 mg and 1.0 mg capsules.
15849685|NCT04045483|Other|Virtual reality based cognitive training|The VR-based cognitive training consists of a three-dimensional simulation of home, a mart, bus stop, and street. It provides an integrative cognitive training experience where participants are required to accomplish some common ADL's in three frequently visited places: home, a supermarket, and bus stop.
15849686|NCT04045470|Device|Microdevices|The microdevice was developed as a tool with the ultimate goal to help screen several existing and investigational drugs directly within a patient's tumor to identify what drugs are the most effective for treating a patient's cancer.
15849687|NCT04045470|Other|Standard of care therapy|Participant to receive standard of care therapy as previously determined by participant's treating oncologist and/or dermatologist, which may include a skin-directed or systemic therapy
15849688|NCT04045470|Other|Standard of care systemic therapy|Participant to receive standard of care therapy as previously determined by participant's treating oncologist and/or dermatologist, which must include a systemic therapy.
15849689|NCT04045457|Procedure|dry needling|insertion of needle into active myofascial trigger point
15849690|NCT04045444|Other|walking|Every participants will performed a set of tasks of 2 min. Each task will be separated by a 2 min resting period. The tasks will be walking at 3 km/h, walking while doing the cognitive task, walking at the preferred speed, walking at the preferred speed while doing the cognitive task.
15849691|NCT04045444|Other|cognitive task|Every participants will performed a set of tasks of 2 min. Each task will be separated by a 2 min resting period. The tasks will be a cognitive task, a control cognitive task.
15849692|NCT04045431|Device|PAAG-OA|Intra-articular injection of 6ml PAAG-OA in the target knee
15849693|NCT04045431|Device|Synvisc-One|Intra-articular injection of 6ml Synvisc-One in the target knee
15849694|NCT04045418|Device|Laser doppler|"A laser doppler flowmetry will be used to measure the microcirculatory characteristics of meridian phenomena. The probes will be left at relevant measuring sites. Blood flow curve and Perfusion units (PU ) will be recorded constantly.
~Healthy control group and COPD group The probes will be left at Shenmen (HT7) and Shaohai (HT3) of the Heart meridian, Taiyuan (LU9) and Chize (LU5) of the Lung meridian for 5 minutes.
~Healthy intervention group Two sessions of moxibustion will be performed in the Heart meridian and Lung meridian successively."
15849695|NCT04045405|Drug|CDR132L|i.v. administration
15849696|NCT04045392|Behavioral|Mediterranean diet|Two meals (breakfast and dinner) a day, five times a week, are delivered to participants' homes without charge. The meals are prepared, under the supervision of an expert nutritionist, by a chef trained on the principles of the Mediterranean diet.
15849764|NCT04044755|Other|Myopia prediction algorithm|Candidate predictors mainly includes age at examination, SER, and annual progression rate. Using these predictors, the algorithm will be used to predict SER at 3 years.
15849765|NCT04044742|Drug|Resiniferatoxin|Receiving Resiniferatoxin injection
15849697|NCT04045379|Procedure|LASER|Use of the SmartXide Touch V²LR, Co2 Laser System to perform ambulatory intravaginal and vulvar application of LASER, to postmenopausal genitourinary syndrome. The patient will be in gynecological position, after remove of vaginal secretion, with gauze and under topic anesthesia, the LASER will be applied, according to the protocol of the manufactured.
15849698|NCT04045379|Procedure|Microablative Radiofrequency|Use of Linly™ equipment to perform ambulatory intravaginal and vulvar application of fractionated microablative radiofrequency, to postmenopausal genitourinary syndrome. The patient will be in gynecological position, after remove of vaginal secretion, with gauze and under topic anesthesia, the radiofrequency will be applied, according to the protocol of the manufactured.
15849699|NCT04045379|Drug|Estriol|The patient will perform self application of this vaginal estriol daily for 2 weeks and after that the applications will occur twice a week.
15849700|NCT04045366|Other|Sample collection|Plasma and BAL sample collection
15849701|NCT04045353|Behavioral|Low carbohydrate diet education|A 200 page informational document that connects with an online application will be provided to subjects.
15849702|NCT04045353|Behavioral|Low carbohydrate diet education with behavioral component|A 12 week course taught be a certified instructor will teach subjects about a low carbohydrate document. Subjects will also be given a 200 page informational document that connects with an online application.
15849703|NCT04045340|Device|Philips QLAB Ultrasound Quantification Software|Offline processing of intraoperative transesophageal echocardiography would be performed with Global Longitudinal Strain on apical 4 chamber, apical 2 chamber and long axis views in order to analyze left ventricle and left atrium contractility and right ventricle free wall motion
15849704|NCT04045327|Drug|Normal saline + Standard Treatment|Normal Saline to be Used as Vehicle in the Phase-III Study to Assess Efficacy of PMZ-2010 as a Resuscitative Agent for Hypovolemic Shock
15849705|NCT04045327|Drug|Centhaquine + Standard Treatment|Phase-III Study to Assess Efficacy of PMZ-2010 as a Resuscitative Agent for Hypovolemic Shock
15849706|NCT04045314|Other|Topical moisturizer|The investigational product is an intensive emollient cream that is applied topically on the skin and is manufactured by Avicanna Inc. This preparation contains widely used ingredients from mineral and botanical origin aimed at soothing and conditioning the skin as well as improving hydration. The moisturizer also contains 1% hemp oil rich in essential fatty acids and antioxidants as well as 0.5% of CBD with regulatory and conditioning effect on the skin
15849707|NCT04045301|Biological|Omalizumab 16mg/kg|Participants will receive omalizumab 16 mg/kg monthly doses for 12 weeks, followed by omalizumab 8 mg/kg monthly for 4 weeks and then omalizumab 4 mg/kg monthly for 4 weeks, for a total of 20 weeks including a taper period.
15849708|NCT04045301|Biological|Omalizumab 8mg/kg|Participants will receive omalizumab 8 mg/kg monthly doses for 12 weeks, followed by omalizumab 4 mg/kg monthly for 4 weeks and then omalizumab 2 mg/kg monthly for 4 weeks, for a total of 20 weeks including a taper period.
15849709|NCT04045301|Biological|Placebo|Participants will receive placebo for 8 weeks prior to the initiation of oral immunotherapy and 12 weeks after for a total of 20 weeks including a taper period.
15849710|NCT04045301|Other|Multi-food oral immunotherapy (OIT)|Multi-food oral immunotherapy will be conducted to a mix of three foods. It will be started 8 weeks after study drug with an initial food escalation. Participants will undergo biweekly increase until they tolerate a maintenance dose of 1500 mg (500 mg per food) of food protein.
15849711|NCT04045288|Behavioral|Standard Implementation|Schools in the Standard implementation model received web-based training, access to on online education / tracking system and programming resources (modules, posters, trinkets) to facilitate wellness programming in their school. They completed audit tools at the beginning to facilitate goal setting and received weekly emails during the 12-week implementation process.
15849712|NCT04045288|Behavioral|Enhanced Implementation|Schools in the Enhanced implementation model received the same training, web-access, and programming resources as those in the Standard implementation, but also received enhanced monthly support during implementation from the project team. The supplemental web calls (completed jointly by Extension leaders and SWITCH staff) utilized motivational interviewing to help schools build capacity and to enhance motivation for wellness programming.
15849713|NCT04045275|Behavioral|Calm|"Calm provides daily, 10-minute, guided meditations grounded in mindfulness-based stress reduction (MBSR) and Vipassana meditation. Calm also offers Sleep Stories, developed using techniques from Cognitive Behavioral Therapy and Relaxation Technique. Clam also includes behavioral components to reinforce sustained practice."
15849714|NCT04045249|Dietary Supplement|Home based food|Home based food is compare able to RUTF
15849715|NCT04045236|Other|Registry|Data collection
15849716|NCT04045223|Other|Blood samples|Maternal blood will be taken at arrival at the delivery unit and after delivery. Furthermore, placental blood will be taken after delivery.
15849718|NCT04045197|Behavioral|Relaxation Focused Nursing Care|"Relaxation Focused Nursing Care is composed of HypnoBirthing and Transactional Model. Hypnobirthing Philosophy is based on the laws of mind and aims to create positive thoughts and emotions. The Transactional Model defines stress as a special relationship between the person and the environment. Therefore, Relaxation Focused Nursing Care; positive language, positive environment and reducing stressors."
15849719|NCT04045184|Other|Food assistance|This is an observational study of an existing community program. No intervention is provided beyond food assistance in the community program.
15849720|NCT04045171|Drug|Tacrolimus|Tacrolimus, oral, 0.05-0.075 mg/kg/d, Q12h, 6～12 months
15849721|NCT04045145|Drug|NBI-74788|NBI-74788 administered orally for 14 consecutive days.
15849766|NCT04044742|Drug|Placebo|Receiving Placebo injection
15849722|NCT04045132|Behavioral|Social Media-Based Parenting Program|Participants in the intervention group will be enrolled in Facebook secret user groups, administered by a trained facilitator, in order to permit participants to view and comment on posted materials. Content and user identity are restricted to invited participants to maintain privacy. For each topic, we organize educational materials into video vignettes, narrated PowerPoint presentations, and written materials. The facilitator reviews and comments on postings daily, provides feedback to participants, and removes inappropriate postings if they occur. Facebook analytics for the secret groups are available to group administrators and will provide information on any sessions viewed (engagement) and counts of sessions viewed and comments posted (dosage). Women in the intervention group will also be enrolled in the online depression treatment program, MoodGym.
15849723|NCT04045132|Behavioral|MoodGym|Participants in the control group will be enrolled in MoodGym, an evidence-based online Cognitive Behavioral Therapy (CBT) program for depression. Through the MoodGym program, participants will have access to interactive exercises, workbooks, anxiety and depression quizzes, and downloadable relaxation audio files. We will supplement Moodgym with a facilitator contact by texting or email to check-in and encourage completion of intervention. MoodGym will provide information on the number of sessions completed by participants (engagement and dosage).
15849724|NCT04045119|Other|Topical Moisturizer|The investigational product is a moisturizing facial cream for skin with imperfections that is applied topically and is manufactured by Avicanna Inc. This preparation contains widely used ingredients from mineral and botanical origin aimed at improving skin hydration and characteristics associated acne-prone skin. The moisturizer also contains 0.1% of hemp oil rich in essential fatty acids and antioxidants and 0.5% of cannabidiol with regulatory effect on the skin.
15849725|NCT04045106|Other|Proprioceptive Neuromuscular Facilitation Patterns|The participants were asked to sit on a chair, the therapist performed the pattern of movement himself then passively applied the pattern on the participant then asked the participant to perform the pattern, and the therapist observed and corrected the movement if it was done improperly.Then participants were told that the therapist will resist their movement, they were also told to keep breathing normally and to report any discomfort and/or pain.After mastering the pattern,the therapist placed one hand on the participant's mandibular and the other hand approximately between parietal and occipital bones to apply resistance through out the ROM, each pattern performed for 3 sets of 10 repetitions with 1-2-minute rest between sets.
15849726|NCT04045106|Other|Proprioceptive Neuromuscular Facilitation stretching|was done for 6 repetitions with hold for 6 seconds in position of stretch and sub maximal isometric contraction for 6 seconds, 1-2-minute rest was given before changing the target muscle group
15849727|NCT04045106|Other|Passive range of motion|ineffective passive ROM for 10 repetitions for flexion, extension, right and left side bending and right and left rotation, it was done from neutral position to the limit of motion without causing any stretch to the muscle.
15849728|NCT04045093|Drug|Dabigatran etexilate|Subjects will be randomized into 2 groups in a 1:1 ratio, to receive either Dabigatran or Warfarin for stroke prevention, in a open-label design.
15849729|NCT04045093|Drug|Warfarin|Subjects will be randomized into 2 groups in a 1:1 ratio, to receive either Dabigatran or Warfarin for stroke prevention, in a open-label design.
15849730|NCT04045080|Device|AMADEO|"AMADEO® is an end-effector system enables intensive training with frequently repeated gripping movements. It offers the possibility to select from between passive, assistive and active modes using exercise of finger strength, finger movement, movement control and a selective activation of the fingers.
~Moreover, even without muscular strength, active work can be done using EMG-based training. The Continuous Passive Motion (CPM Plus) therapy facilitates the implementation of automatic movement sequences even when the patient is unable to complete the entire range of motion on their own. It may be used in all phases of finger-hand rehabilitation and can be adapted to the needs of every patient.
~In patients with PD, it will be useful in improving bradykinesia and potentially distal hypostenia."
15849731|NCT04045080|Other|Training|training
15849732|NCT04045080|Other|OT Training|training
15849733|NCT04045067|Procedure|Isolation of pulmonary veins|Low voltage areas are identified and treated by radiofrequency. Atrial fibrillation is treated by heat produced by an electric current: radio frequency. This is an intervention that consists of blocking abnormal electrical activity, especially in the pulmonary veins.
15849734|NCT04045067|Procedure|Ablation by radiofrequency of low-voltage areas|The defragmentation is guided by a map of fragmented potentials, made through a topography catheter, to locate the most abnormal areas that are the target of ablation.
15849735|NCT04045054|Behavioral|Link Team|A VA home care Link Team (clinical pharmacist, social worker, physical activity trainer) provides the intervention based on a conceptual model of home care as a bridge between hospital and home, in which three interconnected domains determine short-term and long-term outcomes: medical complexity (e.g., medication management), social complexity (e.g., caregiving, environment), and functional impairment (e.g., mobility, physical activity). The Link Team provides support and assessment for each domain, and will use tablet technology and wearable sensors in the home to gather patient data and facilitate communication. At the end of formal home care services, the Link Team provides patient-centered care in: 1) support for the the Veteran and caregiver in the event of changes in medical condition or medications and social or caregiver stressors; and 2) coaching to the Veteran and the caregiver during this transition period to optimize functional mobility and physical activity.
15849736|NCT04045041|Behavioral|Acceptance and commitment therapy|An acceptance based intervention with focus on exposure.
15849740|NCT04045015|Dietary Supplement|Liqourice|Liqourice corresponding to 1.5, 3.0 or 6.0 mg glycyrrhizic acid per kg body weight is taken in the evening during 7 days.
15849741|NCT04045002|Other|'MyPinkMom' educational intervention|"The intervention will be carried out for 2 weeks. There will be three sessions of 'MyPinkMom' that will be delivered to respondents per week. In each session, a respective 'MyPinkMom' video with audio explanation will be delivered to respondents in intervention group through WhatsApp application. It will be delivered every alternate day per week and each video will take about 3 minutes duration. Each session has its own objective and different content.
~Each of the respondent in the intervention group will be given 'MyPinkMom' diary in which they are required to document time of iron tablet intake daily as well as time of reading of 'MyPinkMom' material in each session. At the end of the intervention, a meeting with all the respondents from the intervention group will be held for question and answer session."
15849742|NCT04044989|Device|Laser|Diode laser device was used for photobiomodulation
15849743|NCT04044989|Device|light-emitting diode (LED)|LED device was used for photobiomodulation
15849744|NCT04044989|Device|Placebo|Diode laser device was used for placebo effect
15849745|NCT04044976|Drug|Caffeine Citrate|Infants will receive 20 mg/kg of caffeine citrate intravenously, via the umbilical vein, or enterally, through an orogastric tube, within 10 min of birth.
15849746|NCT04044963|Behavioral|Exercise and Prehabilitation|"All participants who are allocated to the exercise group will be asked to complete 4-5 days per week of mixed modality exercise incorporating aerobic, resistance, and flexibility training. The aerobic component can include any modality the patient is capable of doing, including walking, swimming or biking. By the end of the prehabilitation period the target will be 30 minutes of aerobic exercise three times a week at an intensity of 3-5 RPE. The resistance component will include 5-6 exercises using body weight and resistance bands. The target will be 12 repetitions and 3 sets, two times a week. The flexibility component will include 5 exercises that can be completed at the end of each session.
~Participants will self-report their participation in the prehabilitation program based on an electronic survey."
15849747|NCT04044950|Biological|E7 TCR|The injection will be approximately 3x10^8 E7 TCR T cells, unless fewer cells are generated, at each site of organ involvement (i.e. primary tumor, palpable lymph node (s)) in approximately 1-2 mL of volume.
15849748|NCT04044937|Drug|F-18 Fluoroethyltyrosine (FET)|Patients given an injected dose of 4 to 7 millicurie (mCi) of FET per scan. The radiopharmaceutical will be administered while the patient is in the PET scanner
15849749|NCT04044937|Procedure|Positron Emission Tomography (PET)|All patients receive single PET imaging lasting for 40 minutes. Acquired PET data will be reconstructed so that three time points are created: (1) Perfusion: 60-second acquisition that starts immediately when activity is noted in the field of view, (2) Equilibrium: 10-minute acquisition acquired between 10 and 20 minutes after injection, and (3) Washout: 10-minute acquisition acquired between 30 and 40 minutes after injection. A repeat PET image will be offered to adult patients.
15849750|NCT04044911|Behavioral|Task model (CogWatch)|
15849751|NCT04044898|Drug|ALA 5%|prepare 5% ALA solution, apply topically to the affected area for 1.5 hours, single dose
15849752|NCT04044898|Drug|ALA 10%|prepare 10% ALA solution, apply topically to the affected area for 3 hours, single dose
15849753|NCT04044885|Behavioral|Nap|Looking at the difference between continuous sleep opportunities and split-sleep opportunities.
15849754|NCT04044872|Diagnostic Test|[1-13C]pyruvate along with MRI imaging|[1-13C]pyruvate: 0.1 mmol/kg dose will be injected at 5 mL/s followed by a 25 mL saline flush at 5 mL/s at the time of imaging performed at baseline (prior to radiation therapy), and 1 month after completion of radiation therapy.
15849755|NCT04044859|Genetic|Autologous genetically modified ADP-A2M4CD8 cells|Infusion of autologous genetically modified ADP-A2M4CD8 on Day 1
15849756|NCT04044846|Behavioral|Physical activity program for homebound older adults faciliated by Personal Support Workers|The intervention is an evidence- informed, theory-driven mobility intervention for community-dwelling OAs who are moderately and severely frail according to the clinical frailty scale (Rockwood et al., 2005). The intervention, entitled Promoting Movement in OAs (ProMO), will be implementable with frail OAs in partnership with any care provider in the home. Investigators will focus the study on the two main providers of care- personal support workers (PSWs) and family caregivers. OAs, PSWs, and caregivers will co-create ProMO with us. ProMO will be distinct from existing home-based exercise programs (Johnson et al., 2003) (Giangregorio et al., 2018) because it will optimize natural opportunities for mobilization during care (e.g., bathing and dressing) and will be embedded in facilitated activities of daily living.
15849757|NCT04044833|Behavioral|Health life style behaviour ,|Training: applying Personal Information Form, HLBS-II, and MSQ to the intervention and control groups determined randomly and distributing the Student Follow-up Schedules; c) Providing trainings to the intervention group; d) Monitoring the weights, BMIs, and menstrual symptoms of intervention and control groups; and e) After the Training: Applying HLBS-II and MSQ scales to intervention and control groups, collecting the follow-up schedules, and providing training to the control group and all other students. Trainings: First stage: 120 minutes basic training per week for four weeks (40 minutes on diet, 40 minutes on physical activity, and 40 minutes on menstrual symptoms)
15849758|NCT04044820|Drug|Standardized Prescription|"Oxycodone 5mg PO q4-6h PRN
~If patient has allergy or other contraindications
~Hydromorphone 1mg PO q4-6h PRN/ Tylenol #3 1-2 tablets PO q4h PRN
~The number of tablets prescribed will depend on the extent of surgical trauma
~0-5 pills for simple surgeries such as a trigger finger release
~10 pills for carpal tunnel or Dupuytren's contracture releases
~15 pills for a ganglion cyst excision or simple tendon transfer
~20 pills for more complex procedures such as distal forearm ORIF or a wrist fusion."
15849759|NCT04044807|Diagnostic Test|Modified National Institutes of Health Stroke Scale|Clinical tool used in the diagnosis of acute stroke developed by the National Institutes of Health, and modified for simplicity.
15849760|NCT04044794|Behavioral|Standard Care|Standard care includes standardized educational materials to promote self-management of body weight along with provision of $60 for participants to purchase supplies or equipment to facilitate weight management.
15849761|NCT04044794|Behavioral|Daily Self-Weighing|Participants will receive a wireless digital scale and will be asked to keep the scale in their home, weigh daily at the same time, and view their weight trajectory on the scale's digital display.
15849762|NCT04044781|Drug|BPN14770, T2310|Subjects will be administered radio ligand T2310 and BPN14770 to determine brain occupancy of BPN14770.
15849763|NCT04044768|Genetic|afamitresgene autoleucel (previously ADP-A2M4)|Single infusion of autologous genetically modified afamitresgene autoleucel (previously ADP-A2M4) Dose: 1.0 x109 to 10x109 transduced by a single intravenous infusion
15849767|NCT04044729|Drug|Cannabidiol|500mg dose, suspended in medical grade olive oil and then mixed into chocolate pudding
15849768|NCT04044729|Drug|Placebo|Placebo
15849771|NCT04044703|Drug|Vancomycin - model-based dosing regimen|A dosing calculator based on a population pharmacokinetic model for vancomycin will be used to generate a participant's intermittent vancomycin dosing regimen. The participant's post-menstrual age, weight, creatinine and the target trough vancomycin level will be entered into the dosing calculator and the dose will be generated (intermittent infusion, dosing frequency will be from 1 to 4 times per day according to the corrected gestational age).
15849772|NCT04044690|Drug|human immunoglobulin G|human immunoglobulin G administered subcutaneously
15849773|NCT04044690|Drug|Placebo|contains 2% human albumin, similar excipients as IgPro20 (Hizentra), same volume, same duration, administered subcutaneously
15849774|NCT04044677|Device|tDSC-active|10 sessions of active Transcranial Direct Current Stimulation combined to Virtual Reality therapy followed by a one-month washout and 10 sessions of sham Transcranial Direct Current Stimulation
15849775|NCT04044677|Device|tDCS-sham|10 sessions of sham Transcranial Direct Current Stimulation combined to Virtual Reality therapy followed by a one-month washout and 10 sessions of active Transcranial Direct Current Stimulation
15849776|NCT04044664|Drug|Placebo oral capsule|Matching placebo capsules.
15849777|NCT04044664|Drug|NYX-783|NYX-783 is a small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
15849778|NCT04044651|Drug|Lenvatinib|lenvatinib 12 mg (or 8 mg) by mouth (Po) once daily
15849779|NCT04044651|Drug|Nivolumab|nivolumab 480 mg IV infusions for 30 minutes q4w
15849780|NCT04044638|Other|Resistance trainining|Resistance training sessions were held 3 times a week, in which each session lasted 60 minutes and was performed for a period of 8 weeks. Each session consisted of 10-minute warm-up, shortly after, starting the exercises in the form of alternating circuit by segment, as: machine bench press, extension chair, high pull (front), flexor table, direct curl, leg press, triceps pulley, adductor, abdominal, abductor and calf. In all 10 exercises, 3 sets of 8 to 12 repetitions were performed, with an interval of 60 seconds between sets and intensity of 12 arbitrary units (a.u.) to 14 a.u., measured by the rate perception effort scale. In the first, fourth and eighth week, pre-exercise blood pressure (BP) was verified, in which the participants sat for a period of 10 minutes at rest, in a comfortable chair, with legs uncrossed, feet flat on the floor, back leaning on the chair, left arm at heart level and palm up to measure BP using a G * Tech-branded automatic digital device (MASTER model).
15849781|NCT04044625|Device|High-intensity NPPV|In the high-intensity NPPV group, patients will undergo pressure-limited NPPV (eg, NPPV in spontaneous/timed mode) at a higher IPAP level. IPAP is initially set at 10 cmH2O and continuously adjusted by increments and decrements of 1-2 cmH2O (typically ranging between 20 and 30 cmH2O), according to patients' tolerance, to obtain a tidal volume (VT) of 10-15 mL/kg. IPAP should be increased as much as possible to decrease PaCO2 to a normal level. However, if PaCO2 decreases to less than 35 mmHg, IPAP should be decreased to achieve normocapnia.
15849782|NCT04044625|Device|Low-intensity NPPV|In the low-intensity NPPV group, patients will undergo pressure-limited NPPV (eg, NPPV in spontaneous/timed mode) with a conventional IPAP level. IPAP is initially set to 10 cmH2O and is continuously adjusted by increments and decrements of 1-2 cmH2O (up to 20 cmH2O), according to patients' tolerance, to obtain a VT of 6-10 mL/kg.
15849783|NCT04044612|Other|Medial Unloader Brace|medial knee unloader braces use a three point bending system to increase space in the medial tibiofemoral compartment during weight bearing
15849784|NCT04044599|Drug|Gynoflor|VAGİNAL GYNOFLOR
15849785|NCT04044573|Procedure|Transperineal Focal Laser Ablation (TPLA)|The intervention will take place in an ambulatory setting of the interventional radiology department using the combined Echolaser XVG system. The treatment consists of a local anesthesia to the perineal region. Within each needle, an optic fiber of 300um will be inserted. Each ablation lasts 6 minutes and each fiber ablates1800J at a power of 2-3W. At the end of the ablation there is a pull-back of about 1cm from the original ablation location. According to the dimension of the middle lobe of the prostate, multiple pullbacks can be used. The total ablation is 3600J for 2 fibers (1800J/ fiber) at the power of 2-3W for a total duration of about 30minutes. At the end of the treatment, a 20mg bolus of i.v. corticosteroid is given for anti-edema and anti-inflammatory effects. Antibiotic therapy (Ciprofloxacin 500mg and gastroprotective therapy is given for 5 days. After an adequate amount of time for observation, the patient is dismissed.
15849786|NCT04044560|Biological|blinatumomab|Continuous intravenous infusion
15849787|NCT04044547|Drug|Rotigotine, extended-release microspheres|"Four stable dose levels of LY03003 at 14, 28, 42 and 56 mg will be evaluated. For each dose level, the stable dose will be administered once a week for consecutive 5 weeks. To improve patient's tolerability, dose upward titration will be applied to 28, 42 and 56 mg dose groups according to the following schedule:
~Patients to be enrolled to 14 mg dose group will receive 14 mg for 5 consecutive weeks.
~Patients to be enrolled to 28 mg dose group will receive 14 mg in the first week and then 28 mg in the next 5 weeks.
~Patients to be enrolled to 42 mg dose group will receive 14 mg in the first week, 28 mg in the second week and then 42 mg in the next 5 weeks.
~Patients to be enrolled to 56 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week and then 56 mg in the next 5 weeks."
15849822|NCT04044313|Drug|Lenvatinib|12 mg (or 8 mg) once daily (QD) oral dosing.
15849823|NCT04044313|Drug|Toripalimab|240mg intravenously every 3 weeks
15849824|NCT04044300|Procedure|Single screw fixation|A single trans-iliac, trans-sacral screw will be inserted at the sacral one or sacral two level based upon fracture location.
15849825|NCT04044300|Other|Conservative|Continued pain management and physical therapy.
15849826|NCT04044287|Drug|200 micrograms of misoprostol|200 micrograms of powdered misoprostol applied sublingually together with standard parenteral oxytocic therapy
15849788|NCT04044547|Drug|Placebo, extended-release microspheres|"Four stable dose levels of placebo at 14, 28, 42 and 56 mg will be evaluated. For each dose level, the stable dose will be administered once a week for consecutive 5 weeks. To improve patient's tolerability, dose upward titration will be applied to 28, 42 and 56 mg dose groups according to the following schedule:
~Patients to be enrolled to 14 mg dose group will receive 14 mg for 5 consecutive weeks.
~Patients to be enrolled to 28 mg dose group will receive 14 mg in the first week and then 28 mg in the next 5 weeks.
~Patients to be enrolled to 42 mg dose group will receive 14 mg in the first week, 28 mg in the second week and then 42 mg in the next 5 weeks.
~Patients to be enrolled to 56 mg dose group will receive 14 mg in the first week, 28 mg in the second week, 42 mg in the third week and then 56 mg in the next 5 weeks."
15849789|NCT04044534|Drug|Intranasal insulin|Subjects in this arm will receive intranasal insulin (80 IU per day).
15849790|NCT04044534|Drug|Placebo|Subjects in this arm will receive placebo.
15849791|NCT04044521|Other|Systems consultation|"Systems consultation consists of three implementation strategies: academic detailing (AD), practice facilitation (PF), and physician peer consulting (PPC). Clinics will receive a combination of these strategies for 18 months.
~AD: Clinicians will attend an educational meeting that will detail the study and Center for Disease Control guidelines for opioid prescribing in primary care. Clinicians will then will get a monthly audit & feedback report on their prescribing.
~PF: clinics will be randomized to receive practice facilitation. Facilitators will travel to each clinics. Facilitators walk through the clinic, identify areas of opioid prescribing workflow improvement, conduct a nominal group technique with the change team, and set a Plan-Do-Study-Act cycle. Clinics will follow-up with the facilitators monthly.
~PPC: Clinicians of the clinics will meet quarterly with the physician peer consultant to discuss tough patient cases and panels regarding opioid prescribing."
15849792|NCT04044508|Dietary Supplement|Ketocal 4:1 liquid Nutricia (intervention)|Modified ketogenic diet
15849793|NCT04044508|Dietary Supplement|Fortini multifibre Nutrica (placebo)|Placebo diet
15849794|NCT04044495|Other|Multimodal brain imaging (MRI)|Multimodal brain imaging (MRI)
15849795|NCT04044495|Other|Actimetry|7 days actimetry
15849796|NCT04044495|Other|Sleep Diary|7 days Record of sleep and wake cycle
15849797|NCT04044469|Behavioral|Immunization-enhancement|This group receives a standardized information text, suggesting that medical diagnostics is not very accurate. Reasons for why a serious disease is overlooked are mentioned and discussed.
15849798|NCT04044469|Behavioral|Immunization-inhibition|This group receives a standardized information text, suggesting that medical diagnostics is very accurate and that doctors are very often right in their first initial diagnostic assessments.
15849799|NCT04044469|Behavioral|Control group|This group receives no further information after watching the videotaped doctor's report.
15849800|NCT04044456|Behavioral|Goal Management Training|"GMT: is a 10-session intervention to improve planning and problem solving. Interactive Power Point modules are administered by a cognitive therapist. Each session builds on the steps of a five-stage planning and problem-solving strategy. Veterans will be taught to generate and verbalize the following five-steps: stop-what am I doing?, define the goal, list the steps, learn the steps; then, check-am I doing what I planned? The five-stage strategy is then incorporated into a variety of activities in the laboratory and in-home assignments."
15849801|NCT04044456|Behavioral|Attention Training|"Attention Process Training (APT-III) will be administered for a second weekly session in addition to the GMT session. Each session will be 2 hours/ week for 10 weeks. Veterans will also engage in BrainHQTM attention training at home for one-hour, five days/ week comprised of selected components of BrainHQ from Posit Science Corporation. This web-based computerized CRT modality of cognitive training is a restorative or bottom-up approach that targets basic cognitive skills such as arousal and vigilance processes, attention and information processing, and directly engages fundamental attention-control skills through repetitive graded exercises."
15849802|NCT04044456|Behavioral|Brain Health Workshop|. BHW was developed specifically for consistency with GMT session length and contact with the facilitator49. BHW is an education presentation on brain function and cognitive principles of learning with homework and quizzes on information covered. To match time and contact of attention training, control participants will meet with the therapist for a separate two-hour session from BHW
15849803|NCT04044456|Behavioral|National geographic movies|participants will select movies to watch and answer a few questions about to equate the time and therapist interaction to attention training in arm 1.
15849804|NCT04044443|Device|IMPEDE or IMPEDE-FX|Peripheral vascular embolization
15849805|NCT04044430|Drug|Binimetinib|Given PO
15849806|NCT04044430|Drug|Encorafenib|Given PO
15849807|NCT04044430|Biological|Nivolumab|Given IV
15849808|NCT04044430|Other|Questionnaire Administration|Ancillary studies
15849809|NCT04044417|Procedure|currettage|open flap debridement
15849810|NCT04044417|Drug|curcumin simvastatin paste|Curcumin is the primary active constituent of turmeric. Simvastatin is chemical modification of lovastatin.
15849811|NCT04044417|Drug|EDTA root conditioning|EDTA is an aminopolycarboxylic acid and a colourless, water-soluble solid
15849812|NCT04044404|Diagnostic Test|Ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography)|Compare the ultrasound Integrated Precision Diagnosis Technology(ultrasound elastography) with the diagnostic gold standard of kidney disease---kidney biopsy
15849813|NCT04044391|Diagnostic Test|CardioFlux Magnetocardiograph|CardioFlux is a noninvasive diagnostic modality which can measure and image the heart's intrinsic magnetic field created by ion transit across cardiac cell membranes.
15849814|NCT04044378|Drug|Famitinib|famitinib with RP2D orally daily
15849815|NCT04044378|Drug|Ifosfamide|ifosfamide 1.8g/m2/d d1-3, 15-17 Q4W infusion
15849816|NCT04044378|Drug|Camrelizumab|camrelizumab 200mg infusion once Q2W
15849817|NCT04044352|Biological|Influenza A/Bethesda/MM2/H1N1 Challenge|Reverse-genetics derived live A/California/04/2009/H1N1-like influenza virus passaged six times in Vero cells.
15849818|NCT04044339|Drug|TD-5202|Study Drug to be administered orally
15849819|NCT04044339|Drug|Placebo|Placebo to be administered orally
15849820|NCT04044326|Procedure|The Solero Microwave Ablation|The Solero Microwave Ablation system (Angiodynamics Ltd, USA) with a single microwave applicator operating at a 2.45 GHz will be used to perform MWA
15849821|NCT04044313|Procedure|Hepatic arterial infusion chemotherapy|administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks
15849827|NCT04044287|Drug|Placebo Oral Tablet|200 micrograms of powdered placebo applied sublingually together with standard parenteral oxytocic therapy
15849828|NCT04044274|Device|IOPstim|IOPstim (IMEDOS, Jena, Germany) is a device exerting defined pressure to the sclera and hence increasing IOP.
15849829|NCT04044274|Device|Suction Cup|Suction Cup is a device exerting defined suction to the clear and hence increasing IOP
15849830|NCT04044261|Procedure|Emotion induction using video|Emotions are induced in the test subjects using videos in Hindi and English. Each subject is shown three video clips for each of the emotions.
15849831|NCT04044248|Device|TIPS-obliteration|Transjugular intrahepatic portosystemic shunt (TIPS) decompression of portal hypertension coupled with transvenous obliteration of gastric varices (GVs).
15849832|NCT04044235|Behavioral|PrEP Cohort|AGYW who are eligible for PrEP will be educated about the risk and benefits. For AGYW (aged 18-24 years) who consent to PrEP, an ART provider (nurse or clinician) certified by the MOH will provide PrEP (package of disoproxil fumarate/emtricitabine (Truvada)) on the same day that the client is determined eligible. Peer navigators will ensure linkage to facilities for follow-up care. The initial follow-up visit will occur one month from PrEP initiation to ensure that the client is tolerating the regimen and to answer any questions, with three-month follow-up visits thereafter.
15849833|NCT04044222|Biological|Sintilimab|Given IV
15849834|NCT04044222|Drug|Carboplatin|Given IV
15849835|NCT04044222|Drug|Etoposide|Given IV
15849836|NCT04044222|Drug|Ifosfamide|Given IV
15849837|NCT04044222|Drug|Placebo|Given IV
15849838|NCT04044222|Drug|Carboplatin|Given IV
15849839|NCT04044222|Drug|Etoposide|Given IV
15849840|NCT04044222|Drug|Ifosfamide|Given IV
15849841|NCT04044209|Drug|AG-120|The IDH1 inhibitor ivosidenib (AG-120) that will be administered orally on a continuous basis at the dose of 500 mg/day starting at day 1 of each cycle. A cycle will be defined as a 28-day period.
15849842|NCT04044209|Drug|Nivolumab|On Cycle 2 day 1 the patient will receive nivolumab 480mg once. This will be repeated on Day 1 of every subsequent cycle.
15849843|NCT04044196|Procedure|Rotator cuff repair|Rotator cuff repair performed arthroscopically
15849844|NCT04044183|Behavioral|Active Brains 1|Active Brains uses a multimodal approach to introduce and reinforce new skills, including didactics, in-session activities, discussions, and weekly practice assignments (homework). The Active Brains sessions reflect a purposeful integration of the three treatment approaches (relaxation methods, stress appraisal & coping, and growth enhancement). The format is an 8-week program with weekly meetings and a focus on relaxation response strategies, cognitive behavioral training, positive psychology and mind-body interactions. Active Brains 1 uses a digital monitoring device (i.e., Fitbit) for recording of physical activity.
15849845|NCT04044183|Behavioral|Active Brains 2|"This active comparison condition controls for the effect of time spent, group member support/feedback, and interventionist support/feedback. The original HEP was adapted to provide population-specific information on chronic pain and MCI/MRP symptoms. Participants also receive lifestyle education consistent from public health recommendations and standards for health promotion (e.g., Sleep, Nutrition, Healthy Weight, and Medical appointments). The HEP program consists on 8 group sessions (each session is 90 minutes) that occur concurrently with the active intervention condition. The HEP is conducted in the same format as Active Brains-Fitbit but are not taught the mind-body, walking, or cognitive-behavioral skills. HEP participants are encouraged to set lifestyle goals instead of quota-based walking goals aided by the Fitbit as in the Active Brains-Fitbit condition."
15849846|NCT04044170|Drug|Poziotinib|The poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration.
15849847|NCT04044157|Other|non-invasive measurement of cardiac output|cardiac output will be non-invasivaly measured by means of electrical cardiometry
15849848|NCT04044144|Dietary Supplement|Probiotic Dietary Supplement|Dietary supplement containing a combination of 8 probiotic strains
15849849|NCT04044131|Drug|Metabolic Cofactor Supplementation|Dietary supplement consisting of serine, L-carnitine tartrate, N-acetylcysteine and nicotinamide riboside. Subjects in active treatment will receive dietary supplementation with N-acetylcysteine, L-carnitine tartrate, nicotinamide riboside, and serine, administered as a mixture. Half dosage of the co-factors will be given for two weeks (one dose taken just after dinner), and full dosage for 8 weeks (two equal doses taken just after breakfast and dinner).
15849850|NCT04044131|Drug|Sorbitol|As placebo, sorbitol (5g) flavoured with strawberry aroma and colouring agent will be given.
15849851|NCT04044118|Behavioral|Low Calorie Diet|Low Calorie Diet consisted of ~50% calories of a normal-calorie diet (female, 1000kcal/day; male, 1200kcal/day)
15849852|NCT04044105|Other|Pamphlet education|Patients receive an educational intervention explaining proper opioid disposal
15849853|NCT04044105|Other|Pamphlet education + texts|Patients receive an educational intervention and text message explaining proper opioid disposal
15849854|NCT04044092|Other|Conservative physical therapy|Moist hot packs, TENS, Cervical Traction, Neural Mobilization on alternate days Cervical Spine strengthening exercises 10 repetitions×1 set, 4 days/week. Total of 4 sessions were given each consisting of 40 mins.
15849855|NCT04044092|Other|ELDOA stretching exercise|Experimental group was given ELDOA stretching exercise protocol along with the moist hot packs, TENS, Cervical Traction, and Neural Mobilization on alternate days Cervical Spine strengthening exercises 10 repetitions×1 set, 4 days/week. Total of 4 sessions were given each consisting of 40 mins.
15849856|NCT04044079|Drug|Dinoprostone|1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.
15849857|NCT04044079|Drug|Misoprostol|Misoprostol (200µg) will be administered vaginally 12 hours before office hysteroscopy.
15849858|NCT04044079|Drug|Placebo|one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.
15849859|NCT04044066|Biological|Plasma biomarker|New emerging plasma biomarkers carrying prognositic information
15849860|NCT04044053|Drug|PF-06865571 400 mg Immediate Release (IR) in Fed State|400 mg IR dose in fed state
15849861|NCT04044053|Drug|PF-06865571 50 mg Modified Release (MR) in Fed State|50 mg MR in fed state
15849862|NCT04044053|Drug|PF-06865571 400 mg MR in Fed State|400 mg MR in fed state
15849863|NCT04044053|Drug|PF-06865571 400 mg MR in Fasted State|400 mg MR in fasted state
15849864|NCT04044040|Behavioral|Symptom screening with Targeted Early Palliative care (STEP)|The experimental arm receives routine symptom screening at every outpatient visit; if symptoms are above a certain threshold, then a triggered email is sent to a triage nurse, who calls the patient to offer early referral to and follow-up by a symptom control and palliative care team.
15849865|NCT04044027|Behavioral|S.P.A.R.K (Speaking to the Potential, Ability and Resilience inside Kids) Teen Pregnancy Prevention and Mentoring|S.P.A.R.K is a curriculum-based group intervention for youth ages 11-17 living in out-of-home foster care. The curriculum consists of 23 topical lessons made up of a combination of educational and interactive activities on each topic. The curriculum covers four Adult Preparation Subjects (healthy relationships, educational and career success, healthy life skills, adolescent development) as well as mentoring, bully prevention, emotional competency, self-efficacy, communication, conflict resolution, and pregnancy prevention.
15849866|NCT04044014|Device|Gellan sheet|Gellan sheet.
15849867|NCT04044014|Device|Gellan fluid gel|Gellan fluid gel.
15849868|NCT04044014|Device|Mepitel One|Control dressing-- Mepitel One.
15849873|NCT04043962|Behavioral|Web-based CBT (Web-MAP)|see arm description
15849874|NCT04043936|Behavioral|Cognitive Bias Modification Intervention for Help-Seeking Stigma|Cognitive bias modification (CBM) is an intervention designed to target stigma-related cognitions among individuals at elevated suicide risk not currently engaged in behavioral health treatment. It involves the completion of brief, web-based tasks in which participants are presented with a series of stimuli (e.g., words, sentences) and trained to respond to those stimuli in a manner that is positive or neutral, rather than negative and unhelpful. Consistent with the theoretical rationale for Cognitive Behavioral Therapy, CBM interventions function by reshaping negative cognitions. Repeated reinforcement of adaptive cognitions enhances functioning and reduces distress.
15849875|NCT04043936|Behavioral|Placebo Cognitive Bias Modification (CBM-Placebo)|Cognitive bias modification (CBM) is an intervention designed to target stigma-related cognitions among individuals at elevated suicide risk not currently engaged in behavioral health treatment. It involves the completion of brief, web-based tasks in which participants are presented with a series of stimuli (e.g., words, sentences) and trained to respond to those stimuli in a manner that is positive or neutral, rather than negative and unhelpful. Consistent with the theoretical rationale for Cognitive Behavioral Therapy, CBM interventions function by reshaping negative cognitions. Repeated reinforcement of adaptive cognitions enhances functioning and reduces distress.
15849876|NCT04043936|Behavioral|Self-Directed Psychoeducation|Material presented with information on mental health literacy, mental health stigma, & treatment options. This is based on the idea that increasing knowledge about psychiatric symptoms and treatment options encourages help-seeking behavior and engagement.
15849877|NCT04043923|Drug|Norketotifen|Oral capsule
15849878|NCT04043923|Drug|Placebo|Oral capsule
15849879|NCT04043910|Device|fNIRS|The auditory cortical imaging will be performed by fNIRS measures. This non-invasive functional imaging technique relies on the use of a sensor-bearing cap, measuring cortical activity through scalp, during auditory stimulation. As head movement does not alter measurement that much, fNIRS is well adapted to children.
15849880|NCT04043910|Other|Speech intelligibility|Speech intelligibility will be evaluated with French sentences comprehension in noise, from the Common Test or Adaptive Auditive Speech Test before 6 years, from the Common Test or Hearing in Noise Test for Children (Hint-C) from 7 to 11 years, and from the Hint-C or Marginal Benefit of Acoustic Amplification after 11 years, both with a Signal over Noise Ratio of +10 decibel at 65 decibel
15849881|NCT04043910|Other|Sound localisation|Sound localisation will be evaluated with a left-right discrimination test before 7 years and a 12 loudspeakers sound localisation test after 7 years.
15849882|NCT04043910|Other|Speech assessments|Speech assessments will be performed by dedicated speech therapists, with child age specific tests, and 2 global speech scores: the Category of Auditory Performances scale - second edition, and the Speech Intelligibility Rating scale.
15849883|NCT04043910|Other|Quality of Life|Quality of Life (QoL) evaluation will be based on the generic QoL scale, and the Speech Spatial and Qualities of hearing (SSQ) deafness specific scale. Each scale exists in age specific modalities.
15849884|NCT04043897|Drug|Rifaximin 550mg|Rifaximin 550mg
15849885|NCT04043884|Other|sEmg biofeedback training|Volunteers will perform scapular strengthening and stabilization exercises added to sEMG biofeedback in the upper trapezius (TS), Trapezius (TM), Lower Trapezius (TI), and Serratil Anterior (AS) muscles in real time displayed in a Computer screen.
15849886|NCT04043884|Other|Strength training|The volunteers will perform a strengthening protocol with elbow flexion exercises, medial and lateral shoulder rotation, scapular retraction and push up plus.
15849887|NCT04043871|Diagnostic Test|Systolic blood pressure|Systolic blood pressure measured by Foot-to-Apex Systolic Interval, conventional oscillometric measurement, and the auscultatory method
15849888|NCT04043858|Drug|Midodrine 2.5 mg tab|Patients receive an oral daily dose of 2.5 mg midodrine if age 7-12 years and receive 2.5 mg twice daily of more than 12 years
15849889|NCT04043845|Drug|Ibrutinib|Ibrutinib inhibits the function of Bruton's tyrosine kinase (BTK). Ibrutinib blocks signals that stimulate malignant B cells to grow and divide uncontrollably.
15849890|NCT04043845|Drug|LY3214996|LY3214996 is an extracellular signal-regulated kinase (ERK) inhibitor. ERK inhibitors stop the signal that a cancer cell receives telling it to grow.
15849891|NCT04043832|Diagnostic Test|quantitative ultrasonic technique|Collection of all quantitative ultrasonic data was performed by one ultrasound physician
15849892|NCT04043819|Drug|PSC-01|PSC-01 is a form of autologous cellular therapy resulting from the enzymatic processing of lipoaspirate to yield adipose-derived stromal vascular fraction cells.
15849895|NCT04043780|Device|Decompression prototype splint for carpal tunnel syndrome|This group will wear during 6 weeks a decompression prototype splint. They we be informed to wear it as long as possible during the 6 weeks.
15849896|NCT04043780|Device|Standard splint for carpal tunnel syndrome|This group will wear during 6 weeks a standard splint. They we be informed to wear it as long as possible during the 6 weeks.
15849897|NCT04043767|Procedure|Measurements of thyromental distances, hyomental distances and neck circumferences|thyromental distances, hyomental distances and neck circumferences using measurement tape by two independent investigators.
15849898|NCT04043754|Procedure|Procedure/Surgery: Periodontal surgery with Membrane|Patients will be treated by periodontal surgical flaps with the addition of Membrane+ bone graft
15849899|NCT04043754|Procedure|Periodontal surgery with Platlet Rich fibrin|Patients will be treated by periodontal surgical flaps with the addition of PRF + bone graft
15849900|NCT04043741|Other|Dry Needling|stretching exercises :single knee to chest (15 reps x 3 sets) double knee to chest(15 reps x 3 sets) strengthening exercises: extension exercises (15 reps x 3 sets)
15849901|NCT04043741|Other|Sustain Pressure|"Sustain Pressure (Number of repetition and hold according to trigger point chronic level)
~+ Hot pack 10 to 15 minutes + Active muscle stretching exercise (10 repetition twice daily)"
15849902|NCT04043728|Behavioral|Unified Protocol adapted for smoking cessation|Treatment components are cognitive-behavioral strategies adapted from the Unified Protocol (UP) for the Transdiagnostic Treatment of Emotional Disorders. Behavioral counseling strategies for smoking cessation, drawn from current US Public Health Service guidelines, are incorporated in each treatment module. All participants will be provided with the American Lung Association Freedom from Smoking guide to aid in their quit attempt.
15849903|NCT04043715|Device|Transcutaneous spinal stimulation|Physical therapy to improve standing and walking
15849904|NCT04043715|Device|Epidural spinal stimulation|Physical therapy to improve standing and walking
15849905|NCT04043702|Drug|The intervention being studied|Intervention Other Names have not been specified
15849906|NCT04043689|Device|tACS (transcranial Alternate Current Stimulation)|"This is a single-centric comparative randomized controlled blind and cross-over study.
~The order of stimulation conditions will be randomized: (right frontal tACS / occipital tACS / tACS PLACEBO). The 3 stimulation conditions will be performed with a wash-out period of at least 1 week. In this study each patient will be his own control"
15849907|NCT04043676|Drug|Ponatinib|All patient will take 15 mg/day ponatinib oral during 48 weeks.
15849908|NCT04043663|Device|Virtual Reality glasses|Children are encouraged to watch the virtual reality program at least 24 hours before surgery.
15849909|NCT04043663|Procedure|standard perioperative care without virtual reality program|standard perioperative care without virtual reality program
15849910|NCT04043650|Behavioral|HeartSteps|HeartSteps is a smartphone based mHealth intervention that contains the following intervention components: (1) contextually-tailored suggestions for activity; (2) motivational messages aimed at keeping individuals motivated to be active; (3) planning of the next week's activity; and (4) adaptive weekly activity goals. Activity suggestions provide individuals with suggestions for how they can be active, and are tailored based on time of day, user's location, day of the week (weekend/weekday), and weather. Motivational messages are delivered to individuals via a push notification. Activity planning asks users to create a plan of how they will be active in the coming week. Participants are prompted to plan once a week. Each week, as part of the weekly planning, HeartSteps suggests an activity goal for the coming week based on their activity levels the previous week. Participants can edit the suggested goal, and the system-suggested goals top out at 150 minutes of activity per week.
15849911|NCT04043624|Drug|Lidocaine|regimen of lidocaine administration of 1.5 mg/kg, IV bolus, followed by continuous infusion at 2 mg/kg/h
15849912|NCT04043624|Drug|Saline|IV bolus of saline, followed by continuous infusion of saline
15849913|NCT04043611|Other|Conservative physical therapy management|Tens and hot pack for at least 10 minutes at low back Soft tissue mobilization (Myofascial Release Technique) Maitland's Lumbar segmental mobilization (Grade I & II for pain, Grade III & IV for ROM) Traction (Manual general traction) Neurodynamics (Tensioner technique) Home plan after session (Guided low back exercises):Active Stretching (5-10 repetition with 15-20 second hold), Hamstring, Piriformis McKenzie Prone Extension Exercises
15849914|NCT04043611|Other|ELDOA|ELDOA positions (hold for 1 minute,4 alternate days a week) under supervision during session Conservative physical therapy management Tens and hot pack for at least 10 minutes at low back Soft tissue mobilization (Myofascial Release Technique) Maitland's Lumbar segmental mobilization (Grade I & II for pain, Grade III & IV for ROM) Traction (Manual general traction) Neurodynamics (Tensioner technique) Home plan after session (Guided low back exercises):Active Stretching (5-10 repetition with 15-20 second hold),Hamstring,Piriformis
15849915|NCT04043598|Drug|0.9% Sodium-chloride|We will compare two already established treatment protocols: the use of normal saline versus lactated Ringer's for fluid therapy in patients with subarachnoid hemorrhage.
15849916|NCT04043598|Drug|Ringer's Lactate|We will compare two already established treatment protocols: the use of normal saline versus lactated Ringer's for fluid therapy in patients with subarachnoid hemorrhage.
15849917|NCT04043559|Other|MRI scanner|MRI was performed with a 1.5T magnet (Ingenia, Philips, The Netherlands; diffusion-weighted imaging b-values = 0 and 1,000 s/mm2, TR 4,280 ms, and TE 97 ms). In case of technical problems with the 1.5T MRI scanner, a 3T magnet (Skyra, Siemens, Erlangen, Germany) was used. MRI was analyzed by an experienced rater (DR), blinded to clinical data and MRI sequences other than diffusion-weighted imaging.
15849918|NCT04043559|Other|Contrast transoesophageal echocardiography|Contrast transoesophageal echocardiography (including Valsalva manoeuvre)
15849919|NCT04043546|Behavioral|aerobic+resistance exercise training program|Personalized exercise program based on the inclusion testing and patient screening will be provided to the patient. The program will consist of a gradual walking program as well as a gradual resistance training program using therabands.
15849953|NCT04043403|Device|Intermittent Open Loop DBS (Summit RC+S)|Control for aDBS - DBS intensity or frequency changes in a manner that mimics aDBS but is pre-determined and open loop rather than being responsive to neural or kinematic signals.
15849954|NCT04043390|Diagnostic Test|CRP and Molbio Truenat MTB|A molecular assay to detect M tuberculosis DNA Truenat is currently undergoing the process of endorsement by the WHO.
15850099|NCT04042181|Dietary Supplement|Bifidobacterium longum|Target dose of 1x10^10 CFU/day, plus standard food grade excipients
15849920|NCT04043533|Behavioral|Exercises|The women in the experimental group were given information about the benefits of exercises done in the postpartum period, the time to start these exercises, and the exercises to be conducted in three different phases (mild, medium, severe). The first physical exercise practice was done in the FHC together. In line with the recommendations by ACOG (2015), the women were told to do mild and medium level exercises in the first two weeks, at least five days in a week and at least half an hour daily (ACOG, 2015). They were also told that they should do medium and severe level exercises in the following two weeks. They were asked to mark on the form what time, how long, and at what level they did the exercises every day. The education booklet that included this information and the visuals of the exercises were given to the women in the experimental group. In addition, the women were called once a week in order to check whether the training was applied.
15849921|NCT04043520|Drug|GnRH antagonist|GnRH antagonist will be given once for premenopausal women (12-week intervention) and twice for postmenopausal women (24-week intervention)
15849922|NCT04043520|Drug|Estrogen Product|Estrogen patches will be worn by those randomized to the Estradiol arms in both premenopausal and postmenopausal groups. Patches will be applied weekly and will be worn for the for entirety of the intervention (12 or 24 weeks).
15849923|NCT04043520|Drug|Placebo estradiol|Placebo patches will be worn by those randomized to the placebo arms in both premenopausal and postmenopausal groups. Patches will be applied weekly and will be worn for the for entirety of the intervention (12 or 24 weeks).
15849924|NCT04043520|Drug|Placebo GnRH antagonist|Postmenopausal women randomized to the placebo injection arm will receive two placebo drug injections of normal saline (24-week intervention)
15849926|NCT04043494|Drug|Cyclophosphamide|Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
15849927|NCT04043494|Drug|Cytarabine|"No involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2).
~Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)"
15849928|NCT04043494|Drug|Dexamethasone|Part of the experimental therapy in Randomization R1 (Protocol Ia-Dexamethasone) and in Randomization R2 (Intensified Protocol M)
15849929|NCT04043494|Drug|Daunorubicin|Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
15849930|NCT04043494|Drug|Doxorubicin|Part of standard chemotherapy
15849931|NCT04043494|Drug|Ifosfamide|Part of the experimental therapy in Randomization R2 (Intensified Protocol M)
15849932|NCT04043494|Drug|6-Mercaptopurine|Part of standard chemotherapy and included in the experimental treatment phase protocol Ib* (Randomization 2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
15849933|NCT04043494|Drug|Methotrexate|Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
15849934|NCT04043494|Drug|PEG asparaginase|Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Protocol Ib* (Randomization R2)
15849935|NCT04043494|Drug|Prednisone|Part of standard chemotherapy
15849936|NCT04043494|Drug|Prednisolone|No involvement of CNS: Part of standard chemotherapy. Involvement of CNS: Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1), in the experimental treatment phase Protocol Ib* (Randomization R2) and in the experimental treatment phase Intensified Protocol M (Randomization R2
15849937|NCT04043494|Drug|Thioguanine|Part of standard chemotherapy
15849938|NCT04043494|Drug|Vincristine|Part of standard chemotherapy and included in the experimental treatment phase Protocol Ia-Dexamethasone (Randomization R1) and in the experimental treatment phase Intensified Protocol M (Randomization R2)
15849939|NCT04043494|Drug|Vindesine|Part of the experimental therapy in Randomization R2 (Intensified Protocol M)
15849940|NCT04043468|Other|Audit and feedback|Audit and feedback (A&F) is an intervention that aims to improve professionals practices by providing professionals with a summary of their performance over a period of time.
15849941|NCT04043455|Drug|Olorinab|Olorinab Dose 1 capsule or tablet by mouth, 3 times a day up to 12 weeks
15849942|NCT04043455|Drug|Olorinab|Olorinab Dose 2 capsule or tablet by mouth, 3 times a day up to 12 weeks
15849943|NCT04043455|Drug|Olorinab|Olorinab Dose 3 capsule or tablet by mouth, 3 times a day up to 12 weeks
15849944|NCT04043455|Drug|Placebo|Olorinab matching placebo capsule or tablet by mouth, 3 times a day up to 12 weeks
15849945|NCT04043455|Drug|Olorinab|Olorinab Dose 2 capsule or tablet by mouth, 3 times a day up to 52 weeks
15849946|NCT04043455|Drug|Olorinab|Olorinab Dose 3 capsule or tablet by mouth, 3 times a day up to 52 weeks
15849947|NCT04043442|Device|Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P|rTMS device
15849948|NCT04043429|Behavioral|Vision Restoration Training (VRT)|
15849949|NCT04043429|Behavioral|Vision Exploration Training (VET)|
15849950|NCT04043416|Other|Motivating reminiscence technology|The jDome BikeAround uses Google Street View, a stationary bike and a domed screen. Residents are seated in front of the screen; their destination is typed into the computer and when loaded the image appears on the screen. Using pedals on the bike they can propel themselves down the street, steer and change direction as they wish.
15849951|NCT04043403|Device|Open Loop DBS (Summit RC+S)|Standard DBS therapy at a constant frequency and voltage
15849952|NCT04043403|Device|Adaptive (Closed Loop) DBS (Summit RC+S)|DBS that responds to neural or kinematic features of patient's current state
15850100|NCT04042168|Diagnostic Test|In Check Dial test|In Check Dial test will test the ability to actuate the inhaler.
15849955|NCT04043390|Diagnostic Test|CRP and Xpert ULTRA MTB/RIF|A molecular assay to detect M tuberculosis DNA ULTRA is already endorsed by the WHO. However the tests are still considered experimental in Nigeria and Ethiopia.
15849956|NCT04043390|Diagnostic Test|standard test Xpert|The investigators will use Xpert to compare its agreement with scheme 1 (CRP plus Truenat MTB) and scheme 2 (CRP plus ULTRA).
15849957|NCT04043390|Diagnostic Test|Culture as reference standard|The investigators will use culture to assess the sensitivity of schemes 1 and 2
15849959|NCT04043364|Behavioral|LIVE|Learning, Innovation, Volunteers and Empowerment
15849960|NCT04043338|Drug|XC130-A10H|XC130-A10H supplied as a 0.2, 0.4, 0.8, 1.6 or 3.2 mg dose, administered in capsules or tablets
15849961|NCT04043338|Drug|Placebo|Placebo supplied as matching capsules or tablets
15849962|NCT04043325|Diagnostic Test|Specific antibody-secreting cell (ASC) enzyme-linked immunspot (ELISpot) assay|Clinical samples (nasopharyngeal swabs and max. 5 ml blood) will be collected from patients enroled in the KIDS-STEP study (NCT03474991; children aged 1-10 years) at enrolment (day 1), at day 3, and at day 28.
15849963|NCT04043312|Device|Magstim SuperRapid|Transcutaneous magnetic stimulation targeting the left stellate ganglion.
15849964|NCT04043312|Device|Magstim SuperRapid|Sham transcutaneous magnetic stimulation.
15849965|NCT04043299|Drug|100% Oxygen|High flow cylinder oxygen will be administered to women with fetal distress during labor
15849966|NCT04043299|Drug|21% oxygen|High flow cylinder packaged medical air will be administered to women with fetal distress during labr
15849967|NCT04043286|Device|Definitive abutment|With two height options available, On1 Base are selected depending on the thickness of the soft tissue. It remains in position from implant placement to finalization, which leaves the soft tissue undisturbed for optimized healing, moved the restorative platform of Nobel Biocare conical connection implants from bone level to tissue level, thereby simplifying the restorative procedures
15849968|NCT04043273|Behavioral|Characterization of patients expectations and preferences regarding their treatment|Patients will be clustered before and after a principal components analysis (PCA) on PNQ. Observations will be clustered by the Ward method. The number of clusters will be chosen using the Kolinski criteria. Characteristics of patients will be described by cluster.
15849969|NCT04043260|Device|Advisor Pro|The DreaMed Advisor Pro software is a proprietary algorithm, designed to provide a comprehensive analysis of individual diabetes data which consists of glucose levels and insulin delivery history. the Advisor Pro algorithm identifies glucose patterns and their possible causes, which may hamper the patient's glucose control, and recommend on adjustment to the patient-specific insulin treatment profiles as well as suggestions for personalized diabetes management tips (such as timing of meal boluses, bolus delivery compliance and personalized glucose targets).
15849970|NCT04043247|Device|TEAS|Bilateral Neiguan and Zusanli acupuncture points, 2/10Hz Dense wave , 6-9mA,30min
15849971|NCT04043247|Device|TEAS without electrical stimulation|Bilateral Neiguan and Zusanli acupuncture points, with no electrical stimulation
15849972|NCT04043208|Behavioral|Biofeedback|Three sessions of biofeedback will be performed during the first 3 weeks of the intervention period. Biofeedback sessions will be performed 30 min after ingestion of the offending meal: patients will be taught to control abdominal and thoracic muscular activity by providing a visual display of the abdominal and thoracic perimeter; specifically, they will be instructed to reduce the abdominal perimeter (girth). Patients will be instructed to perform the same exercises before and after breakfast, lunch and dinner during the 4-week intervention period.
15849973|NCT04043208|Dietary Supplement|Placebo|Three sessions will be performed during the first 3 weeks of the intervention period. Each session will be performed 30 min after ingestion of the offending meal: abdominal and thoracic perimeter will be recorded but not shown to the patient; patients will take a pill of placebo containing 0.5 g glucose and no specific instructions will be provided. Patients will be instructed to take a pill of placebo before breakfast, lunch and dinner during the 4-week intervention period.
15849974|NCT04043195|Drug|Nivolumab|240 mg every 2 weeks. Nivolumab will continue for up to 2 years.
15849975|NCT04043195|Drug|Oxaliplatin|65 mg/m2 every 2 weeks. Oxaliplatin will continue for up to 12 cycles.
15849976|NCT04043195|Drug|Ipilimumab|1 mg/kg every 6 weeks. Ipilimumab will continue for up to 4 cycles
15849977|NCT04043182|Procedure|ultrassound|The treatment protocol will consist of 10 sessions, lasting 20 minutes. The energy level corresponding to 59 J / cm2 (177 J / cm2) and frequency of 3 MHZ, applied in the anterior region of the abdomen, in a quadrant previously delimited with a ballpoint pen, will be used. The flanks (lateral of the abdomen) will not be treated.
15849978|NCT04043169|Diagnostic Test|Clearblue pregnancy test|Urine pregnancy test
15849979|NCT04043156|Radiation|High-precision RT|18 x 2.33 Gy of high-precision RT in 3.5 weeks
15849982|NCT04043130|Behavioral|Pulse|The intervention provides participants access to Pulse, a web-based mobile health app designed for Black and Latinx women ages 18-20. Participants can access the app autonomously and on their own schedule. The app for the experimental arm, the Pulse treatment app, provides information on birth control, healthy relationships, sexual health and physiology, pregnancy, and utilization of clinical services. The app for the comparator arm, the Pulse control app, provides information on general health topics, such as the importance of sleep, healthy eating, and friendships. Participants receive MMS messages that reinforce app content and remind them to visit the app.
15850071|NCT04042389|Behavioral|Email reminder|"The Email group received oral health messages once a week for four weeks (totaling 4 messages) as a reminder to practice good oral hygiene
~The reminder included an image reminding them to maintain their oral hygiene."
15850072|NCT04042389|Behavioral|Control|No messages sent.
15849983|NCT04043117|Other|Body Image evaluation|"Evaluation of body image perception requires three assessment tools administered at four different times:
~T0: During the first week of admission T1: Three months from the first admission T2: Six months from the first admission T3: One year from the end of the treatment
~Italian Body Image Concern Inventory: 19-items self-report instrument rated on a 5-points Likert scale (1 = never; 5 = always). It consists of two sub-scales to evaluate body image-related dissatisfaction and concern respectively.
~Body Uneasiness Test: 71-item self-report questionnaire on a 6-points Likert scale (0 = never; 5 = always) that consists of two subscales: BUT-A (measuring weight phobia, body image concerns, avoidance, compulsive self-monitoring, detachment and body depersonalization) and BUT-B (measuring worries about specific body parts or functions).
~Human Figure Drawing: qualitative measure of adolescent's body perception; participants are asked a free draw, representing themselves."
15849984|NCT04043117|Other|Self esteem evaluation|"Evaluation of body image perception is achieved administering TMA test at four different times:
~T0: During the first week of admission T1: Three months from the first admission T2: Six months from the first admission T3: One year from the end of the treatment
~TMA (Multidimensional Self-Esteem Test): a 150-items self-report questionnaire for children and adolescents from 9 to 19 years old. It's made up of six subscales: interpersonal relationships, environmental control competence, emotionality, scholastic success, family life, body perception. Participants have to express their agreement with each item according to the following response options: absolutely true, true, false, absolutely false."
15849985|NCT04043104|Drug|intra-parotid administration of AAV2hAQP1|"Open-label, non-randomized, dose escalation trial of AAV2hAQP1 administered via Stensen's duct to a single parotid gland in subjects with radiation-induced xerostomia. Dose levels:
~1 x 1011 vg/mL*
~3 x 1011 vg/mL
~1 x 1012 vg/mL
~3 x 1012 vg/mL
~If 2 subjects experience a dose-limiting toxicity at the 1 x 1011 vg/mL dose level (Dose Group 1), then a lower dose of 3 x 1010 vg/mL may be studied. The total volume to be administered is subject specific, based on the subject's parotid gland volume."
15849986|NCT04043091|Procedure|percutaneous coronary intervention (stenting)|percutaneous stent implantation in coronary artery
15849987|NCT04043078|Other|Exercise|The exercise regime will include daily upper limb aerobic (hand bike) and inspiratory muscle training (POWERbreathe) and upper body strength training every second day until discharge.
15849988|NCT04043065|Biological|Liver-enriched antimicrobial peptide 2|Infusion of LEAP-2 during a 180 min grated glucose infusion.
15849989|NCT04043065|Other|Placebo|Saline
15849990|NCT04043052|Other|Psychological evaluation|Psychological evaluation including: MINI (current diagnosis) ; HDRS ; MDQ ; GAD-7 ; PC-PTSD-5 ; Quality of Sleep (item 6 of the Pittsburgh Sleep Quality Index) ; CES-D ; BAI ; RRS-short form ; IES-R ; mYFAS2.0;
15849991|NCT04043052|Other|Functional evaluation|Functional evaluation including : EQ5-D ; MFI ; LUNS ; SSQ ; Physical activity (IPAQ)
15849992|NCT04043052|Biological|Biological assessment|Biological assessment : White and red blood cells count ; platelets count ; Haemoglobin ; CRPus ; Glycaemia ; Plasmatic HbA1c ; Plasmatic LDLc ; HDLc and triglyceride ; Creatinin clearance, Transaminases.
15849993|NCT04043052|Other|Ecological Momentary Assessment|During 3 months after inclusion, a 3 to 5 minutes daily interview will administer questions concerning mood symptoms, activities, stress experience, substance use, social relationships and medication intake, activities, social interaction, environmental conditions, experience of depressed mood, anhedonia, changes in weight, appetite, sleep, fatigue, feelings of worthlessness or inappropriate guilt, concentration or decision-making difficulty
15849994|NCT04043039|Procedure|Palatal wound bandage with PRF|palatal wound will be protected by a quadruple layer of Platelet Rich Fibrin obtained by folding on itself 2 Platelet Rich Fibrin membranes
15849995|NCT04043039|Procedure|Palatal wound bandage with Gelatine Sponge|palatal wound will be protected by gelatine sponge
15849996|NCT04043026|Drug|Statin|Any statin therapy
15849997|NCT04043013|Device|Mini-Taurus® (Rocky Mountain©) Brackets|
15849998|NCT04043013|Device|Smart Clip® SL3 High Torque (3M Unitek©)|
15849999|NCT04043013|Device|Tip-Edge Plus® (TP Orthodontics©)|
15850000|NCT04043013|Device|Victory® (3M Unitek©)|
15850001|NCT04043000|Dietary Supplement|Super 13 Pro & Prebiotics|"Super 13 Pro & Prebiotics was given three times a day for four weeks."
15850002|NCT04042974|Drug|vaginal dinoprostone|1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office hysteroscopy.
15850003|NCT04042974|Drug|placebo|one tablet of placebo inserted by the patient 12 hours before the scheduled office hysteroscopy.
15850004|NCT04042961|Other|Reactive balance training|A variety of tasks will be included to induce external or internal perturbations. External perturbations will be caused by forces outside participants' control (e.g. a push or pull from the physiotherapist). Internal perturbations are when the participant fails to control the centre of mass-base of support relationship during voluntary movement; e.g., 'agility' tasks such as kicking a soccer ball. Each session will include a five-minute warm-up, at least 60 perturbations, and a five-minute cool-down. The difficulty of the task will be set such that participants will 'fail' to recover balance ~50% of the time; 'failure' is defined as use of an upper extremity response, use of external assistance (i.e. from the overhead harness or physiotherapist), or taking more than 2 steps to regain stability. Training tasks will progressed by increasing the perturbation magnitude, including cognitive or movement tasks, or imposing sensory or environmental challenges (e.g. eyes closed, obstacles).
15850005|NCT04042961|Other|Aerobic and strength training (AST)|"AST sessions will consist of 30 minutes of aerobic and 30 minutes of strength training.
~Aerobic training: Aerobic training will be done using treadmill walking or combination of modalities (e.g. cycling or recumbent stepping) for those unable to maintain the target heart rate with walking. The heart rate that occurred at the ventilatory threshold (V̇O2VT) during the cardiopulmonary exercise test will be used to prescribe intensity. In the absence of a discernible V̇O2VT a combination of the following will be used: 60-80% of heart rate reserve, peak oxygen uptake, and rating of perceived exertion of 11-16 (Borg 6-20 scale). Prescriptions will be initially progressed by increasing duration to ≥20 minutes and then increasing intensity to target heart rate.
~Resistance training: Participants will be prescribed 1-2 sets of 8 exercises per session (squat, heel raise, ankle dorsiflexion, knee extension and flexion, abdominal curl-up, wall push up, bicep curl), at 70% of 1 repetition maximum."
15850006|NCT04042948|Drug|Tylenol|when we decide to remove the drainage tube, we ask the patient to take a pill of tylenol, and another pill in 12h later
15850007|NCT04042935|Drug|Alpha Lipoic Acid|Stage II-IVB HNSCC patients receiving concurrent systemic therapy and radiation in the definitive, adjuvant, or palliative setting will receive ALA according to their prescribed dose level. ALA will be taken orally or per feeding tube. It will start 1 week prior to the start of CRT, continue on through CRT, and then continue for 2 weeks after the completion of CRT. Patients will be given dosing diaries to document date and time of each drug administration as well as any missed doses. They will also have weekly visits to report AEs and concurrent medications, have a history and physical exam, report VAS pain scores and OMAS scores, and fill FACT-HN surveys.
15850008|NCT04042922|Device|GENUS device (Active Settings)|Participants in the experimental group will use the GENUS device configured to active settings for 30 - 60 minutes.
15850009|NCT04042922|Device|GENUS device (Sham Settings)|Participants in the control group will use the GENUS device configured to sham settings for 30 - 60 minutes.
15850010|NCT04042909|Behavioral|Counter Attitudinal Advocacy|same as Counter Attitudinal Advocacy arm
15850011|NCT04042909|Behavioral|Personalized Normative Feedback|same as Personalized Normative Feedback arm
15850012|NCT04042896|Behavioral|exergame|Exergame is 'exercise + game'.
15850013|NCT04042896|Behavioral|treadmill exercise|traditional aerobic exercise
15850014|NCT04042883|Procedure|Acute normovolemic hemodilution|500 ml of blood will be taken from the patient with simultaneous replacement with hydroxyethyl starch (HES 130/0.4) in another IV line
15850015|NCT04042870|Behavioral|Joint Loosening Yoga|Sukshma Vyayama Joint Loosening Yoga was practiced Monday - Friday for four weeks. Each session included twelve joint loosening exercises performed in a chair, each performed 10 times with mindful awareness of physical movements and breath synchronization. Sessions lasted 15 minutes.
15850016|NCT04042857|Device|Next Science Treatment Gel|Next Science Treatment Gel will be applied after nail surface nail-filing and/or debridement.
15850017|NCT04042844|Biological|BRTX-100|Hypoxic cultured mesenchymal stem cells (MSCs) from autologous bone marrow with autologous platelet lysate.
15850018|NCT04042844|Drug|Saline|Sodium Chloride (0.9%) intravenous infusion preparation is a sterile and non-pyrogenic solution
15850019|NCT04042831|Drug|Olaparib|Given PO
15850020|NCT04042818|Diagnostic Test|Rehabilitative Ultrasound|Ultrasound imagining
15850021|NCT04042805|Biological|Sintilimab|200mg intravenously every 3 weeks
15850022|NCT04042805|Drug|Lenvatinib|12 mg (or 8 mg) once daily (QD) oral dosing.
15850023|NCT04042792|Other|pharmacokinetics (PK) measurement|two ADA-PK samples will be collected during routine rheumatology visits in case of medical indicated blood draw (1 trough PK sample and 1 random PK sample per subject)
15850024|NCT04042779|Other|model-based WM training|model-based WM training program: four sessions a week, 45 minutes each; lasting for three weeks
15850025|NCT04042779|Other|single-task WM training|single-task WM training program: four sessions a week, 45 minutes each; lasting for three weeks
15850026|NCT04042779|Other|multiple-task WM training|multiple-task WM training program: four sessions a week, 45 minutes each; lasting for three weeks
15850027|NCT04042779|Other|sham intervention|motor training program: four sessions a week, 45 minutes each; lasting for three weeks
15850028|NCT04042766|Procedure|laser vaginal treatment|Er:YAG laser
15850029|NCT04042753|Drug|Ipilimumab|Ipilimumab 3 mg/kg every 3 weeks,
15850030|NCT04042753|Drug|Nivolumab|Nivolumab 1 mg/kg every 3 weeks for 4 cycles
15850031|NCT04042753|Drug|Nivolumab|Following concurrent ipilimumab and nivolumab, patients will receive single agent nivolumab at 480 mg every 4 weeks for 6 cycles (1 cycle=4 weeks) with the option of continuing until disease progression or until the end of the study, whichever occurs first
15850032|NCT04042740|Drug|Glecaprevir/Pibrentasvir (G/P)|Fixed-dose combination (FDC) tablets containing 100 mg of glecaprevir and 40 mg of pibrentasvir; administered as 3 tablets orally.
15850033|NCT04042740|Drug|Ribavirin (RBV)|Tablets containing 200 mg of ribavirin. RBV dosed according to weight-based and renal dosing tables in study protocol.
15850034|NCT04042727|Drug|Dexmedetomidine Hydrochloride|Six vials of Dexmedetomidine hydrochloride 100mcg/ml (2ml per vial) will be added to a 250mL bag of normal saline by the investigational pharmacy to prepare for infusion by patient's bedside nurse. Infusion rate will be 1mcg/kg/hr.
15850035|NCT04042727|Other|Normal Saline|0.5% sodium chloride (NaCl). The investigational pharmacy will prepare the normal saline placebo 250mL bag for infusion by patient's bedside nurse. Infusion will be 1mcg/kg/hr.
15850036|NCT04042714|Drug|All patients- TAS-102|Patients will receive TAS-102, Orally, BID for 5 days a week with 2 days rest for 14 days, followed by a 14-day rest treatment cycle. Treatment may continue until disease progresses, intolerable toxicity is developed, or if the patient becomes pregnant or dies.
15850037|NCT04042701|Drug|Trastuzumab deruxtecan (DS-8201a)|"Part 1: Two dose levels of DS-8201a (3.2 mg/kg Q3W and 5.4 mg/kg Q3W via intravenous (IV) infusion will be administered for the dose escalation part of the study in combination with pembrolizumab.
~Part 2: Once Part 1 of the study is complete and a RDE for DS-8201a has been established, Part 2 will begin. All participants will receive DS-8201a at the RDE in combination with pembrolizumab."
15850038|NCT04042701|Drug|Trastuzumab deruxtecan (DS-8201a)|"Part 1: Two dose levels of DS-8201a (3.2 mg/kg Q3W and 5.4 mg/kg Q3W via intravenous (IV) infusion will be administered for the dose escalation part of the study in combination with pembrolizumab.
~Part 2: Once Part 1 of the study is complete and a RDE for DS-8201a has been established, Part 2 will begin."
15850039|NCT04042701|Drug|Pembrolizumab|All participants will receive pembrolizumab (200 mg Q3W) via intravenous (IV) infusion prior to DS-8201a in Parts 1 and 2 of the study.
15850040|NCT04042688|Drug|intraarticular administration of tranexamic acid|Intraarticular administration with concentration of 30mg/mL was selected. The operation room nurses prepared 3g tranexamic acid in 100 mL of saline solution during operation. After finishing surgical wound suture and orthopaedic surgeons related to this study left operation room, the orthopaedic residents who were not involved in the postoperative evaluation administered tranexamic acid solution through suprapatellar pouch before tourniquet release in patients in the treatment group. The control group did not receive any solution. intraarticular drain was not inserted in all patients.
15850073|NCT04042376|Drug|Ibrutinib|Ibrutinib will be administered orally, once daily, at a dose of 420 mg (140 mg*3 capsules taken together at one time).
15850132|NCT04041895|Other|Audio speech recording|Audio recording of speech sample from subject description of Cookie-Theft image.
15850041|NCT04042675|Diagnostic Test|observational study|There will be two groups in this study. One of the groups will consist of 30 parkinson's patients aged between 40-75 years and 1-3 according to Hoehn-Yahr stage. The other group will consist of 30 healthy individuals between the ages of 40-75 and without any neurological disorders. Participants' respiratory muscle strength, exercise capasity, fatigue and physical activity levels will be assessed. All asessements will done for only one time.
15850042|NCT04042662|Other|no intervention|no intervention
15850043|NCT04042649|Behavioral|environmental intervention|provide environmental intervention (help sleep cycle, provide comfortable environment)
15850044|NCT04042623|Drug|AVB-S6-500|AVB-S6-500 is experimental drug
15850045|NCT04042610|Behavioral|Electronic Prompt for Interrupting Sitting Time|An electronic prompt via the IOS application Stand-Up will be given through the Amazfit BIP device to interrupt sitting time every hour during the office workers workday. The office worker will engage in 2 minutes of physical activity with each prompt.
15850046|NCT04042597|Drug|Anlotinib Hydrochloride|anlotinib was given at a fixed dose of 12mg D1-14 every 21 days
15850047|NCT04042584|Procedure|Visio conference device evaluation (DVCM)|Standard neurological tele-evaluation (limited to 15minutes) remotely carried out by a first neurologist via a tablet (DVCM) and an operator. A second neurologist assist at the assessment without intervention next to the patient. Once the remote assessment is complet, the second neurologist ensure the continuation of standard patient care.
15850048|NCT04042571|Device|Cerebral oxymetry monitoring (NIRS)|Near-InfraRed Spectroscopy (NIRS) is a non-invasive method measuring tissue oxygenation by regional saturation of capillary-oxygenated hemoglobin (rSO2). Starting on day 4 after aneurismal rupture NIRS electrods will be placed and maintained until day 12 permanently and blindly recording rSO2. Patients will be monitored following daily practice recommandations inclunding vasospasm detection and treatment.
15850049|NCT04042558|Drug|Carboplatin + Pemetrexed + Atezolizumab + Bevacizumab|4 cycles of induction every 3 weeks of cisplatine,pemetrexed, atezolizumab + bevacizumab and patients without disease progression, treatment will be followed by maintenance therapy by Atezolizumab + Pemetrexed +/- Bevacizumab administered at the same dosage on 3-week cycles
15850050|NCT04042558|Drug|Carboplatin + Pemetrexed + Atezolizumab|Carboplatin + Pemetrexed + Atezolizumab
15850051|NCT04042545|Drug|PPP001|1 cannabis dosing capsule inhaled 3 times a day with a vaporizer device
15850052|NCT04042545|Drug|Placebo|1 placebo dosing capsule inhaled 3 times a day with a vaporizer device
15850053|NCT04042532|Device|Theta-burst stimulation (TBS)|We will perform standard intermittent TBS (iTBS) parameters to left DLPFC of every patient in the study. The frequency parameters of TBS are 3-pulse 50-Hz bursts, every 200 ms at 5 Hz, and the intensity is 90% of active motor threshold. A single session of iTBS contains 2 s of TBS repeated every 10 s for 20 times. In this study, we will give two sessions of iTBS separated by 15 min.
15850054|NCT04042519|Diagnostic Test|Lung function test was performed on the subjects with Jaeger lung function instrument of Germany.|This Jaeger lung function instrument of Germany is used to test the pulmonary ventilation function of COPD patients. Since the condition requires drug control and treatment, the drug cannot be stopped.
15850055|NCT04042519|Diagnostic Test|Agilent 1290 Infinity LC system (UHPLC, Santa Clara CA) was used for Targeted metabolite detection.|We used the Agilent 1290 Infinity LC system mass spectrometer to analyze and detect metabolite peaks of patients according to retention time and mass/charge ratio after preliminary experiments and derivatization.
15850056|NCT04042519|Diagnostic Test|Routine blood test|Blood routine test results include CRP, PCT, white blood cell count, red blood cell count, neutrophil percentage, eosinophil, basophil, et al.
15850057|NCT04042506|Drug|Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]|480mg IV every 4 weeks
15850058|NCT04042506|Radiation|Stereotactic Body Radiation Therapy (SBRT)|SBRT dose of 8-10 Gy x 3 fractions (at maximum 3 doses per week) delivered to 1 extracranial site between days 1-14 of Cycle 1.
15850059|NCT04042493|Behavioral|Connect for Health|The program includes (1) electronic health record (EHR)-based clinical decision support tools to guide pediatric providers in child weight management; (2) clinician and medical staff training in obesity management best practices, (3) family educational materials focused on evidence-based behavioral targets; and (4) social- and community-informed text messages for parents to support behavior change.
15850060|NCT04042480|Drug|SGN-CD228A|SGN-CD228A administered intravenously
15850061|NCT04042467|Behavioral|Greenlight Plus|Families randomized to the Greenlight Plus arm will receive a HIT intervention starting at the newborn clinic visit. During the newborn visit, these families will receive basic instructions on how to access the Greenlight technology platform, which includes the iOTA text-messaging application and a website (usable on desktop or mobile platform). Families will receive text messages and goal-setting over the first 2 years of the child's life.
15850062|NCT04042467|Behavioral|Greenlight|All residents and families seen in the participating clinics will receive the basic Greenlight materials.
15850063|NCT04042454|Other|milk based anti-regurgitation infant formula|Cow's milk-based infant formula containing the thickener locust bean gum containing prebiotic oligosaccharides and postbiotics
15850064|NCT04042454|Other|Milk based infant formula|Cow's milk-based infant formula containing prebiotic oligosaccharides and postbiotics
15850065|NCT04042441|Drug|Insulin Degludec/Insulin Aspart|Insulin Degludec/Insulin Aspart (Ryzodeg®) as prescribed by the patient's treating physician. The decision to initiate or switch into treatment with commercially available Ryzodeg® has been made before, and independently from, the decision to include the patient in this study.
15850066|NCT04042428|Drug|Somatropin injection|Subjects receive a daily subcutaneous dose of 0.2 IU/kg (0.067 mg/kg) of recombinant somatropin (rhGH) during 14 days.
15850067|NCT04042415|Other|Caloric restriction|Patients will be treated with a diet regimen of mild caloric restriction (15-20% caloric restriction)
15850068|NCT04042415|Other|Caloric restriction without cow's milk and gluten|Patients will be treated with mild caloric restriction (15-20% caloric restriction) plus excluding from diet cow's milk, its derivatives and gluten.
15850069|NCT04042402|Drug|DCR-PHXC|Multiple fixed doses of DCR-PHXC by subcutaneous (SC) injection
15850070|NCT04042389|Behavioral|WhatsApp reminder|"The WhatsApp group received oral health messages once a week for four weeks (totaling 4 messages) as a reminder to practice good oral hygiene
~The reminder included an image reminding them to maintain their oral hygiene."
15850237|NCT04041050|Drug|Navitoclax|Tablet; Oral
15850238|NCT04041050|Drug|Ruxolitinib|Tablet; Oral
15850074|NCT04042363|Device|Transorbital electrical stimulation (Eyetronic Next Wave 1.1)|"Calibration phase: The patient will use a response button to indicate the threshold from which he feels a luminous sensation (phosphene). In a second step, he will use the same answer button to indicate the stimulation frequency from which the phosphenes become continuous.
~Stimulation phase: From these 2 parameters (amplitude and frequency), the stimulation session will begin for a duration of approximately 40 to 50 minutes, the settings being dependent of the individual thresholds."
15850075|NCT04042363|Device|Transorbital electrical stimulation (Eyetronic Next Wave 1.1) - Sham stimulation|The calibration phase is identical to the active stimulation. During the stimulation phase, the operator will manually interrupt the stimulation 60 seconds after the start of the session.
15850076|NCT04042350|Other|Non-interventional|Exploring clinical risk factors associated with the risk for cardiovascular events and mortality, rather than to evaluate specific drugs.
15850077|NCT04042337|Behavioral|Pivotal Response Treatment|PRT will target functional communication abilities
15850078|NCT04042324|Drug|Triferic|Triferic (ferric pyrophosphate citrate, FPC), an iron-replacement product, is an iron complex in which iron(III) is bound to pyrophosphate and citrate.
15850079|NCT04042324|Drug|Heparin|Unfractionated heparin (UFH): a common anticoagulant used during hemodialysis treatments.
15850080|NCT04042311|Other|High-intensity interval training|a high-intensity interval training programme completed 3 times a week for 6 weeks using a stationary Wattbike.
15850081|NCT04042298|Other|Arterial blood pressure|Measured using an automated non-invasive finger cuff that obtains beat-by-beat blood pressure measurements via finger photoplesmography. Briefly, changes in artery diameter are detected through infrared light in the finger cuff. (Finometer Pro, FMS, The Netherlands).
15850082|NCT04042298|Other|Skin microcirculatory blood flow|Assessed non-invasively in the forearm skin via Laser Doppler flowmetry in response to locally delivered acetylcholine and norepinepherine or phenylepherine via iontophoresis.
15850083|NCT04042298|Other|Brachial artery blood flow|A GE Ultrasound System will be used to non-invasively assess brachial artery blood flow prior to and following a standard flow mediated dilation protocol.
15850084|NCT04042298|Other|Venous blood draw|A venous blood sample from the antecubital vein or a vein in the back of the hand will be taken via venipuncure by a nurse or a certified phlebotomist at the beginning of the experimental visit. These blood samples will be analyzed for the presence of reactive oxygen species and inflammatory markers.
15850085|NCT04042285|Device|Extracorporeal shockwave therapy|Extracorporeal shockwave therapy will be given at 120 pulses/cm2, penetration 5mm at a dose of 0.1mJ/mm2 at 5 pulses/second. Participants will receive 3 sessions of shockwave therapy in a 7-day period.
15850086|NCT04042285|Other|Standard Wound Care|dressing changes, negative pressure wound therapy, offloading footwear, debridement, glycaemic control and antibiotics as necessary
15850087|NCT04042272|Diagnostic Test|S100β, Neuron specific enolase (NSE) and Glial fibrillary acidic protein (GFAP)|S100β is 10.4 kDa protein. Synthesized with end-feet processes of astrocytes in the brain S100β belongs to low molecular weight EF-hand type acidic calcium-binding protein superfamily. This protein is metabolized in the kidneys and removed with urine. It is shown that S100β does not show differences due to ethnical groups or genders and is not affected by circadian rhythm. Although S100β is also found in other tissues, it is in higher concentrations in the brain so it can be used as an early indicator for brain damage.NSE is an SSS protein which exists in neurons and neuroendocrine tissues. NSE plays a role in glycolytic route in neurons as intracytoplasmic enzyme increasing serum level in case of neuron damage. Whilst S100β is the marker of astroglia dysfunction, NSE is the marker of neuronal dysfunction. Glial fibrillary acidic protein (GFAP) is the intermediate filament cell skeleton protein found in astrocytes. It originates from the same root structure as S100β.
15850088|NCT04042259|Device|Abthera|Negative Pressure Wound Therapy Device
15850089|NCT04042259|Procedure|Open adbdomen for post-laparotomy without NPWT device|Historic cohort treatment of open abdomen for dirty wounds without use of negative pressure therapy device
15850090|NCT04042246|Behavioral|Information Provision|Provide the information on the importance of the vaccination and tailored vaccination schedule
15850091|NCT04042233|Drug|Experimental Intraosseous vancomycin 500mg in 250 mL NS|500mg of Vancomycin in 250 mL of normal saline will be injected into a pre-specified region of the greater trochanter during primary total hip arthroplasty.
15850092|NCT04042233|Drug|Standard IV administration of vancomycin|IV antibiotics (cefepime & vancomycin) are started in pre-op approximately 1 hour prior to incision (vancomycin dose weight-based at approximately 15mg/kg, generally 1000-1750mg in 500 mL NS).
15850093|NCT04042220|Drug|Glucocorticoids|Effect of glucocorticoids (which are often prescribed for cerebral edema) on clinical outcome
15850094|NCT04042207|Device|Low Glucose Predictive Suspend system|consists of sensor-augmented pump therapy (SAP) / Low Glucose Predictive Suspend system (with predictive low glucose management technology)
15850095|NCT04042207|Device|DBLHU System|DBLHU system embeds a regulation algorithm to automatically regulate the patient's glycaemia. It takes as input glycaemia value received every 5 minutes from the CGM and patient inputs related to meals and physical activities and it calculates the amount of insulin to be delivered. It sends this information to the pump that automatically delivers this quantity.
15850096|NCT04042194|Procedure|Placement of Implants and Thickening Peri-Implant Mucosa with T-PRF|A total of 40 ml blood sample was collected from the antecubital vein of the patients' right or left arms with 10 ml injectors. 40 ml blood was transferred to a grade-IV titanium tube for the T-PRF group. The titanium tubes containing the blood samples were instantly centrifuged in a tabletop centrifuge at room temperature. The blood samples of the T-PRF group were centrifuged clockwise at 2700 RPM for 20 minutes. Subsequent to the centrifugation process, the clots of the T-PRF group were removed from the tubes with sterile tweezers, separated from the RBC base with scissors, and left for over 20 minutes on sterile woven gauze to release the serum slowly from the collected clots. The implants were placed in thin tissues, and the thickness of the thin tissues was simultaneously increased with T-PRF.
15850097|NCT04042194|Procedure|Placement of Implants and Thickening Peri-Implant Mucosa with CTG|The implants were placed in thin tissues, and the thickness of the thin tissues was simultaneously increased with CTG. Autogenous connective tissue graft was harvested according to a single incision technique.
15850098|NCT04042181|Dietary Supplement|Placebo|standard food grade excipients
15850239|NCT04041050|Drug|Celecoxib|Capsule; Oral
15850101|NCT04042155|Drug|dabigatran, rivaroxaban, apixaban or edoxaban|Record of all serious complications associated with any of the drugs and the clinical changes that occurred during prospective follow-up.
15850102|NCT04042142|Other|glucagon|Infusion of low dose glucagon and high dose glucagon during simultaneous somatostatin infusion and replacement doses of insulin and growth hormone. Infusion of palmitate, VLDL-triglyceride and glucose tracers.
15850103|NCT04042129|Other|gynecologic operations with urological complications|
15850104|NCT04042116|Drug|Lucitanib|Oral lucitanib will be administered once daily (QD) at the starting dose of 6 mg.
15850105|NCT04042116|Drug|Lucitanib|Oral lucitanib will be administered once daily (QD). The dose will be 6 mg.
15850106|NCT04042116|Drug|Lucitanib|"Oral lucitanib will be administered once daily (QD) at the starting dose of 6 mg.
~Subjects will be allowed to intrapatient dose escalate in increments of 2 mg up to a total dose of 10 mg QD lucitanib if they meet the study specific clinical criteria."
15850107|NCT04042116|Drug|Nivolumab|IV nivolumab 480 mg will be administered once every 4 weeks.
15850108|NCT04042103|Drug|Tapinarof cream, 1%|Tapinarof cream, 1% applied topically once daily
15850109|NCT04042090|Device|Reducept, virtual reality|The VR serious game Reducept is a novel psychological VR intervention for treating chronic pain. It incorporates several psychological therapies into one application: hypnotherapy, mindfulness, ACT and EMDR. Reducept has been made in co-creation with patients, researchers, psychologists and developers and can be installed and played on a VR goggles. It consists of an education module and three games.
15850115|NCT04042051|Drug|Copanlisib|Copanlisib is supplied as lyophilized preparation in a 6mL injection vial. The total amount of copanlisib per vial is 60mg. The solution for IV infusions is obtained after reconstitution with normal saline solution. Copanlisib will be administered on Days 1 (and 8 and 15 [according to the dose escalation scheme]) of each 21-day cycle. Copanlisib will be administered first over 60 minutes followed by the infusion of trastuzumab emtansine.
15850116|NCT04042051|Drug|Trastuzumab emtansine|Trastuzumab emtansine 3.6mg/kg IV infusion on Day 1 of each 21-day treatment cycle.
15850117|NCT04042038|Behavioral|Cognitive-behavior therapy (psychological treatment)|Participants will receive up to 20 hours of manualized and structured CBT based on exposure and response prevention by experienced clinicians
15850118|NCT04042025|Biological|Onasemnogene Abeparvovec-xioi|Onasemnogene abeparvovec-xioi is a non-replicating recombinant adeno-associated virus serotype 9 containing the human survival motor neuron gene under the control of the cytomegalovirus enhancer/chicken β-actin-hybrid promoter. Onasemnogene abeparvovec-xioi administered as a one-time intravenous (IV) infusion or intrathecal (IT) injection. Dosage determined by participant weight.
15850119|NCT04042012|Other|Eccentric exercise|soleus eccentric exercise
15850120|NCT04042012|Other|PNE|the application of galvanic current
15850121|NCT04042012|Other|Combined|soleus eccentric exercise and PNE
15850122|NCT04041999|Behavioral|Daily Cognition Training Program|"Tasks are carried out in which the subject has to exercise different cognitive functions (praxies, attention, language, memory orientation, gnosias and executive functions; mainly working memory decision making, planning, reasoning and temporal estimation) during the development of AIVD For this, similar materials are used to those that the elderly could find in daily tasks or when solving day-to-day problems.
~Specifically we focus on tasks related to taking medication and adherence to treatment. Some examples of tasks are: the management of a medical prescription, expiration of a medication, understanding of the prescriptions made by the doctor, guidelines for taking medication (doses, schedules ...) and indications and contraindications, filling pill boxes, recall of controls doctors, medication control, prospective memory of medical management, etc."
15850123|NCT04041986|Device|Transcranial Direct Current Stimulation (tDCS)|Transcranial direct current stimulation (tDCS) is a form of non-invasive neuromodulation that uses constant, low (1-2mA), direct current delivered via electrodes on the head.
15850124|NCT04041973|Drug|Artemether-lumefantrine|"One tablet AL contains 20 mg artemether and 120 mg lumefantrine
~The prophylaxis will start with a 3-day course of twice daily AL. This will be followed by 2 doses 8 hours apart on one day per week for up to 3 28-35 day consecutive follow-up periods and for 4 weeks after leaving the forest."
15850125|NCT04041973|Dietary Supplement|Multivitamin|"One tablet contains Vitamin-A : 5000 USP units, Vitamin D: 400 USP Units, Ascorbic acid: 75 mg, Thiamine Mononitrate: 2 mg, Riboflavin: 3 mg, Niacin amide: 20 mg.
~The prophylaxis will start with a 3-day course of twice daily AL. This will be followed by 2 doses 8 hours apart on one day per week for up to 3 28-35 day consecutive follow-up periods and for 4 weeks after leaving the forest."
15850126|NCT04041960|Other|Transcranial magnetic stimulation (TMS)|The TMS protocol to be used, excitatory intermittent theta burst stimulation (iTBS), has been shown to have minimal risk in children as young as 6 (Hong et al., 2015), as well as adults (Huang et al., 2005). This stimulation paradigm uses a series of theta burst stimulation (TBS) units. Each unit consists of 3 pulses of stimulation given at 50 Hz (Huang et al., 2005). Excitatory iTBS consists of 20 sets of 10 TBS units (2 second duration) repeated every 10 seconds for a total of 190 seconds. One session of excitatory stimulation delivers a total of 600 pulses.
15850127|NCT04041934|Dietary Supplement|tryptophan|Each experimental session will be carried out over a week. Adolescents will take part randomly in three sessions. In order to limit inter-individual differences, the diet of the first 3 days will be fixed to the RDA followed by 3 days where dietary intake will be supplemented with different protein (PROT REF : ratio = 0,04 PROT1 : ratio = 0,07, session PROT2 : ratio = 0,11). Tryptophan (Trp) / Large neutral amino acids (Lnaa) ratio of proteins taken varies-double-blind between sessions. All proteins had the same dose and packages. Neither the researcher nor the participants were aware of the quality of the protein.
15850128|NCT04041921|Procedure|Percutaneous coronary intervention|
15850129|NCT04041921|Procedure|Coronary Artery Bypass Grafting|
15850130|NCT04041921|Drug|Medical treatment|
15850131|NCT04041908|Other|Experimental Product|2 sachets per day
15850133|NCT04041882|Drug|68Ga-DOTATATE|Intravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-DOTATATE. Tracer doses of 68Ga-DOTATATE will be used to image lesions of NET PET/CT scan.
15850134|NCT04041869|Behavioral|MapTrek|Participants will receive a Fitbit activity monitor and access to the MapTrek game which will be visible on monitors set up in the residential facility.
15850135|NCT04041856|Drug|Povidone Ophthalmic|Povidone-iodine 2% eye drop versus artificial tear drop for treatment of adenoviral keratoconjunctivitis
15850136|NCT04041843|Drug|Apixaban|Apixaban 10 mg twice daily p.o. for seven days followed by 5 mg twice daily p.o. for children and adolescents weighting ≥40 kg
15850137|NCT04041830|Behavioral|Visit 1|the participants will fill in the LFPQ questionnaire before and after a lunch test meal
15850138|NCT04041830|Behavioral|Visit 2|this is a replication of Visit 1, testing the reproducibility of the LFPQ and of its response to a meal.
15850139|NCT04041817|Other|Trigger setting of pressure support ventilation|Trigger variations will be performed following increasing steps of 3 L/min every 15 minutes, from 0.2 to 15 L/min (0.2 - 3 - 6 - 9 - 12 - 15).
15850140|NCT04041804|Procedure|semirapid maxillary expansion (SRME)|A Banded Hyrax is going to be used in order to provide an increase in the maxillary transverse dimension
15850141|NCT04041791|Drug|Benzyl penicillin|Benzyl penicillin is a penicillin antibiotic.
15850142|NCT04041791|Drug|Gentamicin Sulfate|Gentamicin is an aminoglycoside antibiotic.
15850143|NCT04041791|Drug|Ceftriaxone|Ceftriaxone is a third generation cephalosporin antibiotic active against a wide range of gram negative and positive bacteria.
15850144|NCT04041791|Drug|Amoxicillin Clavulanate|Amoxicillin Clavulanate is a combination of amoxicillin, a β-lactam antibiotic, and potassium clavulanate, a β-lactamase inhibitor.
15850145|NCT04041791|Other|Intravenous fluid|Maintenance fluids administered for at least 24 hours.
15850146|NCT04041791|Other|Nasogastric feeds|Feeds given via nasogastric tube. Feeds may include cow's milk, breast milk, porridge, formula among others.
15850147|NCT04041791|Drug|Ampicillin|Ampicillin is a penicillin-type antibiotic.
15850148|NCT04041778|Other|Catheter ablation|Substrate ablation. Pulmonary vein isolation.
15850149|NCT04041765|Drug|IgM-enriched IVIG|Contains human plasma protein 50mg/ml. With composition of Immunoglobulin M (IgM) 6mg, Immunoglobulin A (IgA) 6mg, Immunoglobulin G (IgG) 38mg (IgG subcl. approx. 63 % IgG1, 26 % IgG2, 4 % IgG3 and 7 % IgG4), Glucose monohydrate, sodium chloride, water for injections
15850150|NCT04041752|Behavioral|SOLID|condition with a classical meal served using solid food items
15850151|NCT04041752|Behavioral|LIQUID_P|condition with a liquid meal served using a powder solution
15850152|NCT04041752|Behavioral|LIQUID_L|condition with a pre-prepared meal served using a liquid solution.
15850153|NCT04041739|Diagnostic Test|fungal osteomyelitis culture and sensitivity|swabs from ulcer tissue and bone biopsy for culture and sensitivity test and blood sampling
15850154|NCT04041713|Drug|Rett-T|antioxidant cocktail
15850155|NCT04041713|Other|Placebo|Placebo
15850156|NCT04041700|Device|Osia 2 system|System includes the OSI200 implant surgically placed under the skin behind the ear, the BI300 implant osseointegrated in the bone and the external Osia 2 sound processor.
15850157|NCT04041674|Biological|GEO-D02 DNA|Administered by IM injection into the vastus lateralis
15850158|NCT04041674|Biological|MVA/HIV62B Vaccine|Administered by IM injection into the vastus lateralis
15850159|NCT04041674|Biological|B63521^11 gp120|Administered as a IM or SC injection into the vastus lateralis or overlying subcutaneous tissue as the MVA dose
15850160|NCT04041674|Biological|IHV01 Protein|Administered as a IM or SC injection into the vastus lateralis or overlying subcutaneous tissue as the MVA dose
15850161|NCT04041674|Biological|Protein Placebo|"Sodium Chloride for Injection, 0.9% USP
~Administered as a IM or SC injection into the vastus lateralis or overlying subcutaneous tissue as the MVA dose"
15850162|NCT04041661|Other|Active tDCS plus gait training|Participants in experimental group will accept Active tDCS which combined with treadmill
15850163|NCT04041661|Other|Sham tDCS plus gait training|Participants in control group will accept Sham tDCS which combined with treadmill
15850164|NCT04041648|Drug|L606 (Liposomal Treprostinil) Inhalation Solution 51ug|Single ascending dose
15850165|NCT04041648|Device|L606 Inhalation System|Single ascending dose
15850166|NCT04041648|Other|Placebo Solution|Single ascending dose
15850167|NCT04041635|Procedure|Stimuli reduction|Phototherapy goggles and earmuffs will be placed 3 minutes before the venipuncture (leaving the patient in resting state after the manipulation) and will be maintained during the procedure. Monitor alarms and devices will be silenced and will remain silenced and noise in the unit will be minimized during the procedure.
15850168|NCT04041635|Procedure|Usual care|Babies in the control group will receive physical contention with administration of sucrose two minutes before carrying out the venipuncture procedure (usual care). Venipuncture will be performed with 22G extraction needles, or peripheric venous catheter. During the puncture the eyes will not be covered, and monitor alarms and devices be not be silenced.
15850169|NCT04041622|Diagnostic Test|Endoscopy and biopsy|Participants with a positive celiac serology are assessed by endoscopy and duodenal biopsy
15850170|NCT04041609|Drug|LYR-210|Management of Chronic Sinusitis in Adult Patients with nasal polyps (CSwNP) and without nasal polyps (CSsNP)
15850171|NCT04041609|Other|Sham comparator|Sham comparator
15850172|NCT04041596|Device|Advanced Bionics' Acoustic Earhook|designed to deliver acoustic amplification through the modular attachment of the Naída CI Q90 AcoustiEarhook, while also delivering electrical stimulation along the full range of the implanted Advanced Bionics electrode.
15850174|NCT04041570|Biological|cAd3-EBO S vaccine|The recombinant chimpanzee adenovirus Type 3-vectored Ebola vaccine, VRC-EBOADC086-00-VP (cAd3-EBO S) is composed of a cAd3 vector that expresses Ebola Sudan wild type glycoprotein (WT GP).
15850175|NCT04041544|Drug|SN1011|SN1011 will be supplied to the Pharmacy as 25 mg and 100 mg capsules.
15850176|NCT04041544|Drug|SN1011 placebo|The placebo to be used in this study will be identical to SN1011, minus the active ingredient.
15850177|NCT04041531|Other|blood sampling|venous blood sampling for oxygen affinity in-vitro test
15850178|NCT04041518|Procedure|Autotransplantation|Autotransplantation of tooth with an almost fully or completely developed root with intraoperative extraoral apicoectomy.
15850179|NCT04041505|Behavioral|(feeding modality)|The intervention is a change in feeding modality: in both arms, infant's will consume mother's milk. The difference in arms is the modality in which human milk is consumed: either directly from the breast, or from a bottle.
15850180|NCT04041492|Dietary Supplement|Supplementation with Vitamin D3 y K2|Supplementation at a dose of 1 capsule every 24 hours x 3 months
15850181|NCT04041479|Device|Repetitive Transcranial Magnetic Stimulation|iTBS rTMS targeting the DMPFC or left DLPFC
15850182|NCT04041479|Device|Repetitive Transcranial Magnetic Stimulation|iTBS rTMS targeting the left DLPFC
15850183|NCT04041466|Diagnostic Test|AF detection by ECG|Single-lead ECG with Withings watch HWA08 and reference 12-lead ECG
15850184|NCT04041453|Drug|Ivermectin|Ivermectin at 600mcg/kg in addition to albendazole will be provided for 1 or 3 days.
15850185|NCT04041453|Drug|Albendazole|Albendazole will be provided as an active control or in experimental arms for 1 or 3 days with ivermectin.
15850186|NCT04041440|Behavioral|clEAR auditory training|Children play auditory brain training computer games
15850187|NCT04041427|Drug|Albendazole Pill|Albendazole 400mg po
15850188|NCT04041427|Other|High fat content diet|High fat content diet
15850189|NCT04041427|Other|Moderate fat content die|Moderate fat content die
15850190|NCT04041414|Other|Proud & Empowered!|Proud & Empowered! is a school-based intervention to decrease sexual minority stress and improve coping among LGBTQ students. It is administered by school counselors and trained social workers.
15850191|NCT04041401|Other|PICU storybook|Narrative and developmentally appropriate intervention
15850192|NCT04041388|Other|Conebeam CT|medical imaging technique consisting of X-ray computed tomography where the X-rays are divergent, forming a cone
15850193|NCT04041375|Behavioral|iNSPiRED|The peer intervention will include approximately 5 to 6 contacts over a 3-month period. Peer navigators are responsible for providing emotional and social support, normalizing the difficulty of living with DM, modeling help-seeking behaviors, and connecting patients with VHA and/or CBOs to address mental health and DM self-management needs. Peer coaches are not responsible for health education directly; rather, they encourage patients to use appropriate programs in which mental health and DM self-management services are provided.
15850194|NCT04041375|Other|Usual Care|Veterans randomized to the usual care condition will be encouraged to follow-up with their primary care provider and/or specialty providers for management of their health conditions. They will also receive a packet of printed information that includes a list of self-management support resources in the VHA and the local community. They will receive no further specific recommendations
15850195|NCT04041362|Biological|UB-421|Monoclonal antibody by IV infusion plus standard ART
15850196|NCT04041362|Other|Antiretroviral Therapy (ART)|Standard ART
15850197|NCT04041349|Drug|mouse nerve growth factor|mouse nerve growth factor of 20 UG (9000 U)/day for 14 consecutive days by intramuscular injection
15850198|NCT04041336|Diagnostic Test|Optical coherence tomography|Non-invasive method of acquiring cross sectional imaging of tissues using the coherent property of light
15850199|NCT04041310|Biological|GAd-209-FSP low dose|GAd20-209-FSP IM vaccine, low dose
15850200|NCT04041310|Biological|MVA-209-FSP low dose|MVA-209-FSP IM vaccine, low dose
15850201|NCT04041310|Biological|GAd-209-FSP high dose|GAd20-209-FSP IM vaccine, high dose
15850202|NCT04041310|Biological|MVA-209-FSP high dose|MVA-209-FSP IM vaccine, high dose
15850203|NCT04041310|Biological|GAd20-209-FSP, RP2D|GAd20-209-FSP IM vaccine, RP2D
15850204|NCT04041310|Biological|MVA-209-FSP, RP2D|MVA-209-FSP IM vaccine, RP2D
15850205|NCT04041297|Other|Preoperative Pulmonary Rehabilitation|"Each prehabilitation session will last approximately 90 minutes and will include:
~Endurance training at the ventilatory threshold, determined according to the initial CPET. The first session will last for 15 to 20 minutes then increase by 5 minutes each session to reach 45 minutes in total (including a 5-minute warm-up and 5 minutes of active recovery). The intensity will then increase by 5 or 10 W, as could be tolerated;
~Peripheral muscle strengthening at 60% to 70% of the 1-repetition maximum of 3 main components (quadriceps press, whole-leg extension, and upper limb pull down). Three sets of 12 movements will carry out for each exercise and the load will increase weekly as tolerated;
~Inspiratory muscle training using a threshold calibrated to at least 30% of the MIP. Patients will be encouraged to carry out 15 minutes of independent training daily and to increase the resistance regularly.
~Education to bronchial drainage techniques as well as directed coughing."
15850206|NCT04041284|Drug|Fremanezumab|Monthly 225 mg subcutaneous
15850207|NCT04041284|Drug|Placebo|Matching Placebo
15850208|NCT04041271|Other|Cervical range of motion (CROM)|Subjects will perform full-range cervical flexion, extension, side-bending and rotation actively in sitting position. In supine position, cervical flexion-rotation will be performed passively by the assessor.
15850209|NCT04041271|Other|Pressure pain threshold (PPT)|A digital algometer with rubber head will be used to apply pressure on the muscles of subjects. When the subjects start to feel pain, the algometer will be removed immediately.
15850210|NCT04041271|Other|Cranial-cervical angle (CCA)|Subjects will stand in a relaxed position with colour markers on the earlobe and C7 spinous process. A photo of the head posture will be taken to calculate the included angle between the markers and the horizontal line.
15850211|NCT04041271|Other|Jaw kinematics|Jaw kinematics is measured by Ultrasonic Jaw Motion Analyzer (Zebris). The subjects will perform jaw opening, closing, lateral left, lateral right and protrusion for three times.
15850212|NCT04041271|Other|Muscle activation|Surface electromyography is used to assess the activities of bilateral masseter, anterior temporalis, sternocleidomastoid muscle and upper trapezius. Subjects will perform jaw resting and clenching.
15850213|NCT04041258|Procedure|pseudoarthrosis of clavicle|Pseudoarthrosis represents a complication following a fracture, resulting in persistent symptoms and functional limitation, which prolongs the recovery time for the patient and necessitates new surgery. The purpose of surgery for pseudoarthrosis is to re-establish the length and alignment of the clavicle in an environment favorable to the union of bone fragments.
15850214|NCT04041245|Device|Near infrared spectroscopy|"Near infrared spectroscopy will be adopted to assess the microcirculatory characteristics of meridian phenomenon for participants in the two groups.
~Experimental device: a four-channel INVOS 5100C Oximeter (Somanetics Corp., Troy, USA)
~Experimental process: The participants will be allowed to stabilize for 15 minutes in a supine position in the experimental room before formal examination.
~They are asked to keep silent, breathe normally and avoid movement of limbs during the whole measuring period. After ripping the transparent adhesive tape on the probe, the probes will be left at 4 measuring sites. Regional oxygen saturation (rSO2) will be recorded for 5 minutes.
~Measurement sites: Shenmen (HT7) and Shaohai (HT3) of the Heart meridian, Taiyuan(LU9) and Chize (LU5) of the Lung meridian."
15850216|NCT04041219|Drug|Tacrolimus|Recommended starting dose will be in accordance with the established protocol (0.04 mg/kg/dose of ideal body weight), initially administered sublingually for four consecutive doses.
15850217|NCT04041219|Drug|Tacrolimus|Recommended starting dose will be in accordance with the established protocol (0.04 mg/kg/dose of ideal body weight), oral administration after sublingual four consecutive doses
15850218|NCT04041206|Device|Laser doppler|"Laser doppler will be adopted to assess the microcirculatory characteristics of meridian phenomenon for participants in the two groups.
~Experimental device: Four-channel laser doppler flowmetry (PeriFlux System 5000, Sweden).
~Experimental process: The participants will be allowed to stabilize for 15 minutes in a supine position in the experimental room before formal examination. They are asked to keep silent and normal breath and avoid limb movement during the whole measuring period. The probes will be left at 4 measuring sites. Blood flow curve will be recorded constantly using Perisoft software (PeriFlux, Sweden). Microcirculatory flux in the measuring sites will be calculated [Perfusion units (PU) =concentration of moving blood cells (CMBC)×velocity (V)]. The acupoint microcirculation will be recorded for 5 minutes.
~Measurement sites: Shenmen (HT7) and Shaohai (HT3) of the Heart meridian, Taiyuan(LU9) and Chize (LU5) of the Lung meridian"
15850219|NCT04041193|Behavioral|SIDERA^B|The group will receive a kit home-based (a tablet home, access to a daily individualized training program). Five sessions for a week (3 components: monitoring, motor rehabilitation acitivities, motivational support)
15850220|NCT04041193|Behavioral|Usual Care Program|Usual Care program activities (paper and pencil at home)
15850221|NCT04041167|Drug|alpha lipoic acid|alpha lipoic acid treatment
15850222|NCT04041167|Drug|Saline|No alpha lipoic acid treatment
15850223|NCT04041154|Behavioral|Cognitive Fatigue|Participants will perform a cognitively demanding task (spatial attention task), repeatedly, to induce cognitive fatigue.
15850224|NCT04041154|Behavioral|Physical Fatigue|Participants will perform a physically demanding task (grip force exertion task), repeatedly, to induce cognitive fatigue.
15850225|NCT04041154|Behavioral|Rewarding Stimuli|Reward-associated stimuli will be used to study how reward-induced changes in motivational state influence effort choices.
15850226|NCT04041141|Diagnostic Test|CT Scan|An additional cone beam CT will be repeated at midcourse of therapy (3rd week) and during the end of therapy (5th week)
15850227|NCT04041141|Device|Experimental Oral Stent Device|Patients undergoing standard of care planning for head and neck tongue cancer will have a radiation plan of the body imaged via CT scan construction with the experimental oral stent device in place
15850228|NCT04041128|Drug|Lynparza|Lynparza taken orally at a dose of 300mg twice daily for 7 days
15850229|NCT04041115|Dietary Supplement|Non-alcoholic beer|Treatment consisted of 330ml non-alcoholic beer per day, plus an individualized dietary program and an exercise program with a pedometer-based bracelet to reach at least 5000 steps/day during 2 + 8 weeks.
15850230|NCT04041115|Other|control|Treatment consisted of 330ml of water, plus an individualized dietary program and an exercise program with a pedometer-based bracelet to reach at least 5000 steps/day during 2 + 8 weeks.
15850231|NCT04041089|Behavioral|Recognition of objects|"Name of shapes / colors / images / objects
~Classification of shapes / colors / images / objects"
15850232|NCT04041089|Behavioral|Location of objects|"Search for frequent/rarse targets among distractors sharing one or more characteristics with the target
~Hit/catch a stationary/mobile target as quickly as possible"
15850233|NCT04041089|Behavioral|Manipulation of objects|"Storage of shapes/objects
~Use of everyday objects (pen, cutlery, etc.)"
15850234|NCT04041076|Procedure|Major surgical operation|Surgical operation with magnitude defined as major or ultra-major
15850235|NCT04041063|Device|Upper limb robotic training|"Subjects will remain seated in their own wheelchair in front of the InMotion Hand™ Robot (Interactive Motion Technologies, Massachusetts, MA, Figure 6) facing a video screen.
~The arm of the participants will be abducted, forearm supported, and hand grasping a cone shaped handle. Velcro straps will lightly hold the forearm and fingers secure. The InMotion Hand™ robot attaches to the InMotion Arm™ robots to provide 'assisted-as-needed'™ gross grasp and release motion and support for functional reach. In each session, patients perform a total of 1024 movement repetitions (Cortes et al., 2013). Patients will receive a total of 18 sessions (3x/week, 6 weeks) comprising one hour of interactive hand robotic training. The interactive robotic features involve visuomotor task, moving the robotic manipulandum according to targets on a computer screen mounted at eye level."
15850236|NCT04041063|Procedure|Nerve transfer surgery|C5 injury; Teres minor branch of axillary nerve transferred to long head of triceps branch of radial nerve (RN); Brachialis branch of musculocutaneous nerve to anterior interosseous nerve (AIN); Supinator branch of RN to posterior interosseous nerve (PIN). C6 injury; Teres minor branch of axillary nerve to long head of triceps branch of RN; Extensor carpi radialis brevis (ECRB) branch of RN to AIN; Supinator branch of RN to PIN. C7 injury with preserved triceps, loss of grasp/release; Pronator teres branch of median nerve to AIN; Terminal branch of ECRB branch of RN to flexor pollicis longus branch of AIN; Supinator branch of RN transferred to PIN. C7 injury with preserved triceps/finger extension, loss of grasp; Pronator teres branch of median nerve to AIN; Terminal branch of ECRB branch of RN to flexor pollicis longus branch of AIN.
15850240|NCT04041037|Device|Wound Sheet Matrix 2-Layer and Powder Urinary Bladder Matrix|Porcine-derived extracellular matrix will be used in powder and 2-Layer wound sheet form in masses up to 1000 mg. Each product is intended for a one-time use only.
15850241|NCT04041024|Other|tasks and questionnaires|"Each of the 4 experiments is built of a main task. The first task involves a first phase of subjective valuation of food items.
~The second phase requires from the participant to make a choice between two out of three food items selected by the computer."
15850242|NCT04041024|Other|tasks and questionnaires|"Each of the 4 experiments is built of a main task. The first task involves a first phase of subjective valuation of food items.
~The second phase requires from the participant to make a choice between two out of three food items selected by the computer."
15850243|NCT04041011|Drug|1.Experimental: A (Part 1): Fluzoparib and SHR -1316|1．Drug: Fluzoparib capsule will be given orally. Drug: SHR-1316 given intravenously (IV).
15850244|NCT04041011|Drug|2.Experimental: B (Part 1): Fluzoparib and SHR -1316|2．Drug: Fluzoparib capsule will be given orally. Drug: SHR-1316 given intravenously (IV).
15850245|NCT04041011|Drug|3.Experimental: C (Part 2): Fluzoparib and SHR -1316 Expansion|3．Drug: Fluzoparib capsule will be given orally. Drug: SHR-1316 given intravenously (IV).
15850246|NCT04040998|Behavioral|Compensatory Cognitive Training|Teach the participants compensatory cognitive skills and strategies
15850247|NCT04040985|Procedure|Total Knee Arthroplasty using Legion Total Knee System|Primary Total Knee Arthroscopy using Legion Total Knee System
15850248|NCT04040972|Other|Compassion Focussed Therapy|Group compassion focussed therapy. One session every week for 10 weeks. Each session lasts 2.5 hours with two breaks during this time.
15850249|NCT04040959|Drug|Nicotinamide riboside|Nicotinamide riboside is a naturally occurring vitamin B3 derivative found in yeast, bacteria, and mammalian tissues, and also has been detected in cows' milk.
15850250|NCT04040946|Diagnostic Test|MIBI scintigraphy|Performing a MIBI scintigraphy, then, in the case of negativity, a single F18-choline PET
15850251|NCT04040946|Diagnostic Test|F18-choline PET|Realization of a F18-choline PET, then, in case of negativity, a MIBI scintigraphy
15850252|NCT04040933|Device|Marketed Adhesive Bandage #1|On the randomized wound site, a marketed adhesive bandage will be applied.
15850253|NCT04040933|Device|Marketed Bandage #2|On the randomized wound site, a marketed adhesive bandage will be applied.
15850254|NCT04040933|Device|Non-Marketed Bandage #1|On the randomized wound site, a non-marketed adhesive bandage will be applied.
15850255|NCT04040933|Device|Non-Marketed Bandage #2|On the randomized wound site, a non-marketed adhesive bandage will be applied.
15850256|NCT04040933|Device|Non-Marketed Adhesive Bandage #3|On the randomized wound site, a non-marketed adhesive bandage will be applied.
15850257|NCT04040933|Device|Non-Marketed Adhesive Bandage #4|On the randomized wound site, a non-marketed adhesive bandage will be applied.
15850258|NCT04040933|Device|Non-Marketed Adhesive Bandage #5|On the randomized wound site, a non-marketed adhesive bandage will be applied.
15850259|NCT04040920|Device|Ozone|One minute of pretreatment with ozone by using the OzoneDTA device
15850260|NCT04040920|Other|Pits and fissure sealants|cleansing of the occlusal surfaces with a nylon brush and polishing toothpaste; surface etching with 36% orthophosphoric acid for 30'', surface cleaning and drying for 30 '', application of the sealing material, polymerization for 60'';
15850261|NCT04040907|Drug|XNW3009|XNW3009 is a small molecule hURAT1 inhibitor
15850262|NCT04040907|Drug|Placebo|Placebo and active drug will have the same appearance
15850263|NCT04040894|Biological|Teprotumumab|Treatment with 8 infusions of Teprotumumab q3W for a total of 21 weeks. Teprotumumab 10 mg/kg will be administered on Day 1 and Teprotumumab 20 mg/kg will be administered q3W for the remaining 7 infusions.
15850264|NCT04040881|Behavioral|Remote monitoring using smartphone accelerometer|"Patients will be instructed to carry the smartphone around their hips during waking hours, regardless of whether they are at home or outside (a nylon hip holster will be provided) and to keep it turned on at all times.
~Daily steps will be recorded for at least seven days before the start of chemotherapy, and the median baseline number of daily steps will be calculated for each patient.
~On the first day of chemotherapy, patients will receive side effect education as per standard of care. Patients will be instructed to continue carrying the smartphone daily as indicated for the entire duration of the first three chemotherapy cycles.
~At the end of the follow-up period (or sooner in cases of early interruption of chemotherapy due to toxicity or disease progression; a change in chemotherapy regimen; or hospitalizations lasting ≥3 days), patients will rate their satisfaction with the intervention using a Likert-scale questionnaire and open-ended questions."
15850265|NCT04040868|Device|the TiRobot system|The TiRobot system (TINAVI Medical Technologies Co. Ltd.) is a multi-indication orthopedic surgical robot that can be used in spinal, pelvic, and limb surgeries performed via an open or a minimally invasive approach
15850266|NCT04040868|Device|Freehand|conventional fluoroscopy-assisted
15850267|NCT04040855|Other|Medication review|Multi-professional medication review
15850268|NCT04040842|Diagnostic Test|Patients undergoing low anterior resection|Patients before the surgery and one year after the surgery will be assessed with questionnaire.
15850269|NCT04040829|Behavioral|Cognitive remediation therapy (CR)|Cognitive remediation therapy is a behavioral intervention that aims to improve cognition. This intervention has the goal to produce long-term improvements in cognition as well as to generalize these improvements in daily functioning.
15850270|NCT04040829|Behavioral|Supported education (SE)|Supported education (SE) is a behavioral intervention that aims to help people return to school and/or succeed in school. SE offers a wide range of services that are personalized to the needs of each patients.
15850271|NCT04040829|Other|Treatment as usual (TAU)|Treatment as usual (TAU) consists of medication and routine contact with the clinical team.
15850272|NCT04040816|Drug|SAP-001|SAP-001 or placebo treatment in a 4:1 randomization ratio
15850326|NCT04040322|Drug|Placebo IV infusion|Study drug will be initiated at a starting dose of 0.5 ng/kg/min up to 2.0 ng/kg/min. Subjects will receive study drug for 5 consecutive days as an IV infusion over 6 hours each day via a peripheral line.
15850327|NCT04040322|Drug|Iloprost Injection, for intravenous use|Study drug will be initiated at a starting dose of 0.5 ng/kg/min up to 2.0 ng/kg/min. Subjects will receive study drug for 5 consecutive days as an IV infusion over 6 hours each day via a peripheral line.
15850273|NCT04040803|Device|Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS)|Transcranial alternating current stimulation (tACS) and transcranial random noise stimulation (tRNS) are two (CE marked medical devices) new, non-invasive (over the scalp) brain stimulation (NIBS) techniques. Both tACS and tRNS deliver a weak current continuously across the brain using pads placed over the scalp, which has been shown safe and well-tolerated by healthy adults and patients. These two techniques are able to softly alter physiological function within the brain. tACS can influence the brainwaves which have been demonstrated to play important roles in movement, sensation, and thinking functions. tACS and tRNS have been investigated for several years and have been shown to be safe, well tolerated and produce beneficial results in hand movement, hearing, and working memory.
15850274|NCT04040790|Device|Scleral contact lens without a passive artificial iris|Participants wear a scleral contact lens without a passive artificial iris (Design A) on the dominant eye to perform the baseline visual performance assessment
15850275|NCT04040790|Device|Scleral contact lens with a passive artificial iris with low contrast (<1:5)|Participants wear a scleral contact lens with a low contrast (<1:5) passive artificial iris (Design B) on the dominant eye to perform the baseline visual performance assessment
15850276|NCT04040790|Device|Scleral contact lens with a passive artificial iris with high contrast (>1:5)|Participants wear a scleral contact lens with a low contrast (<1:5) passive artificial iris (Design B) on the dominant eye to perform the baseline visual performance assessment
15850277|NCT04040790|Drug|Tropicamide and phenylephrine|Participants receive pupil dilation eye drops on the dominant eye, after baseline measurement and before wearing the scleral contact lenses (Designs A, B and C)
15850278|NCT04040764|Procedure|Tritanium uncemented Total Knee Replacement|This will be an internal pilot study in which patients will be blinded and randomly assigned to 1 of 2 arms with 30 patients in each arm. The first arm will receive a Triathlon knee replacement device which is cemented into place. The second arm will receive an uncemented Triathlon Tritanium TKR.
15850279|NCT04040751|Behavioral|CARE-CITE|The primary CARE-CITE components will be education via web platform. CP completes 6 online CARE-CITE modules (15-30-minute sessions each). Modules include demonstration videos and instructive content covering following areas: principles of functional task practice (i.e., activities of daily living such as eating, grooming, or leisure/vocational activities), adaptation of tasks, and importance of progression of challenging tasks to drive neuroplasticity (i.e., increasing numbers of practice repetitions or weight of objects lifted). Underpinning the content is the concept of autonomy support, with examples of fostering empathy, problem solving, instruction in the use of non-controlling language with role playing situations and the importance of creating choice in activities.
15850280|NCT04040751|Behavioral|Standard of care|The CP will receive a CP support brochure with general caregiving information including website resources to mimic web interaction of intervention group (e.g., stroke caregiver resource site).
15850281|NCT04040738|Procedure|Upper extremity surgery under general anaesthesia|Forearm, wrist and hand surgery after fentanyl and propofol induction of anaesthesia, with sevoflurane maintenance
15850282|NCT04040738|Procedure|Upper extremity surgery under regional anaesthesia|Forearm, wrist and hand surgery under brachial plexus block with 0.4 ml/kg of 0.33% bupivacaine solution Other Names: Marcaine 5 mg/ml Astra Zeneca OGYI-T 6496/14
15850283|NCT04040725|Drug|Rogaratinib|Rogaratinib is an oral drug that inhibits FGFR. Mutations in FGFR help bladder cancer grow.
15850284|NCT04040712|Other|Donor FMT|Fecal microbiota transplantation using stools from healthy donors
15850285|NCT04040712|Other|Sham FMT|Sham fecal microbiota transplantation
15850286|NCT04040699|Biological|KN026 combined with KN046|KN026 and KN046 are given at 20mg/Kg and 3mg/Kg intravenously on day 1of each 2 weeks cycle at the beginning respectively.The dosage will be escalated if adverse events are tolerated according to the scheme.
15850287|NCT04040686|Drug|Injection of 99mTc-NM-02|Patient will be injected with microdose (<100ug) of 99mTc-NM-02 radiotracer
15850288|NCT04040673|Procedure|thyroid lobectomy|routine surgical removal of thyroid for biopsy
15850289|NCT04040673|Device|Raman spectroscopy probe measurement|The measurement of Raman spectra from the excised tissue
15850290|NCT04040660|Drug|NexoBrid|NexoBrid is presented as lyophilized powder and gel vehicle for preparation of a gel for cutaneous use. The API is a concentrate of proteolytic enzymes enriched in Bromelain extracted from the stem of Ananas comosus (pineapple plant)
15850291|NCT04040647|Behavioral|mobilization and ambulation|6-min walk test (6-MWT)
15850294|NCT04040621|Drug|Ceftazidime-avibactam|Single intravenous infusion of ceftazidime-avibactam over 2 hours. Dosage will vary depending upon age, weight and renal function.
15850295|NCT04040608|Other|Influence of screen sizes on responses to visual analog scales of stress|"An open questionnaire will be created by the Clinical Research Direction. The questionnaire will be opened by the examinator who will fulfill the anonymized identification of participants and the type of screens. In a dedicated room at the LaPSCo, the participants will answer the same VAS on four different sizes/types of screens (24-inch screen, laptop, tablet, smartphone) and on paper. Saliva will be collected after answering questionnaires. Heart rate variability and skin conductance will be measured with the use of a wrist watch during 15 minutes, from the entrance in the room to the completion of questionnaires.
~The participant will undergo the same examination within a week (15 minutes)."
15850296|NCT04040595|Procedure|Abdominal fat biopsy|A sample of abdominal fat will be obtained by firstly injecting some local anaesthetic into an accessible area of the abdomen. Using a scalpel, a small incision (approx 2-3 cm) will be made to a depth of approx 15mm and two small pea-sized samples of fat will be removed. The wound will be closed with simple sutures or steristrips.
15850381|NCT04039828|Drug|Zinc Sulfate Dispersible Tablet 20 mg (Elemental Zinc 20 mg as Zinc Sulfate Monohydrate / Tablet)|Half of the tablet (10 mg) for 3 to 6 months old children and one tablet (20 mg) daily for > 6 to 59 months old children. The tablet will be dissolved in a teaspoon of safe water or breast milk and administered once daily for 10 days.
15850298|NCT04040556|Other|Simulation class|Pediatric anesthesia simulation class for anesthesia residences
15850299|NCT04040543|Dietary Supplement|lipid-based nutrient supplement containing adherence markers|The supplement will be provided once daily for 10 days
15850300|NCT04040543|Dietary Supplement|lipid-based nutrient supplement containing or not containing adherence markers|The product containing adherence markers will be provided once daily every other day (5 days total); the product not containing adherence markers will be provided on the intervening days for a total of 10 days.
15850301|NCT04040543|Dietary Supplement|lipid-based nutrient supplement not containing adherence markers|The supplement will be provided once daily for 10 days
15850302|NCT04040530|Procedure|CT-guided cryoablation|Percutaneous computed tomography guided cryoablation with the patient in sedation or general anaesthesia.
15850303|NCT04040530|Procedure|Partial nephrectomy|Surgical removal of the renal cancer, leaving the healthy renal tissue. Surgery is either done laparoscopically, robot-assisted laparoscopically or as an open surgery. The patient is under general anaesthesia.
15850304|NCT04040517|Diagnostic Test|Evoked potential audiometer|The ASSR [ steady state response] test stimuli are modulated pure tones with insert earphone..
15850305|NCT04040504|Device|ERCP procedure with Pentax ED-34i10T2 Duodenoscope with Disposable Cap (DEC)|ERCP procedure using Pentax ED-34i10T2 Duodenoscope with Disposable Cap (DEC) and any necessary accessories.
15850306|NCT04040504|Device|ERCP procedure with Pentax ED-34i10T Duodenoscope|ERCP procedure using Pentax ED-34i10T Duodenoscope with any necessary accessories.
15850307|NCT04040491|Drug|PD-1 blocking antibody, chidamide, lenalidomide and gemcitabine|PD-1 blocking antibody inhibits PD-1. Chidamide is an histone deacetylase inhibitor. Lenalidomide is a potent inhibitor of TNF-α. Gemcitabine is a cytosine nucleoside derivative, its main metabolite incorporates into DNA in cells and mainly acts on G1 / S phase.
15850308|NCT04040478|Device|Transcutaneous monitoring|"Transcutaneous monitoring of oxygen and carbon dioxide by using Radiometer TCM5 flex monitor with 3 electrodes on the patient.
~Abdominal patients are monitored for 4 hours during surgery and for 2 hours in the Post-Anesthesia Care Unit. Arterial blood gasses are drawn from the arterial line 4 times during surgery and 4 times after surgery.
~Patients undergoing vascular surgery are monitored for up to 4 hours during surgery."
15850309|NCT04040465|Drug|Aspirin|Participants will be categorized into 3 BMI groups and will be randomly given various doses of aspirin to compare effectiveness and create a dosing regimen.
15850310|NCT04040452|Drug|Continuous ketorolac|Patients randomized for the treatment arm of the study group will receive a continuous infusion of ketorolac plus an intermittent dose of placebo (plasmalyte) for 48 hours.
15850311|NCT04040439|Drug|Dexmedetomidine Hydrochloride|"[Sedation during and after mechanical ventilation in the intensive care setting] For pediatric patients ages of 6 years and over, dexmedetomidine is usually administrated by continuous intravenous (IV) infusion of at a rate of 0.2 μg/kg/hr, following by continuous infusion at a range of 0.2 to 1.0 μg/kg/hr adjusted to achieve the optimal level of sedation depending on the patient's condition.
~For pediatric patients with corrected gestational ages (gestational age + postnatal age) of 45 weeks to under 6 years, dexmedetomidine is usually administrated by continuous IV infusion at a rate of 0.2 μg/kg/hr, following by continuous infusion at a range of 0.2 to 1.4 μg/kg/hr adjusted to achieve the optimal level of sedation depending on the patient's condition. The dosing rate could be decreased according to the patient's condition as appropriate."
15850312|NCT04040426|Other|Human split thickness skin allograft|Application of a fenestrated human skin graft
15850313|NCT04040426|Other|Additional Outer Dressing Applicaiton|Application of Moisture retentive dressing, and a multi-layer compression dressing
15850314|NCT04040426|Other|Offloading|Patient will be offloaded in a diabetic camboot after treatment, or total contact cast if patient cannot be fit with diabetic offloading boot
15850315|NCT04040426|Other|Fibracol Wound Dressing|Application of Collagen Alginate Dressing
15850316|NCT04040413|Procedure|bariatric surgery|All bariatric procedures
15850317|NCT04040400|Device|intraoperative radiotherapy (IORT)|intraoperative radiotherapy (IORT) during brain tumor resection
15850318|NCT04040387|Device|NightWare Therapeutic System|A wearable digital therapeutic system that will measure physiologic data when worn during sleep to deliver a mild vibration via the watch to elicit arousal thereby disrupting nightmares. This detection and stimulation sequence will be performed according to NightWare's proprietary algorithm.
15850319|NCT04040387|Device|Sham NightWare|NightWare device not providing interventions
15850320|NCT04040374|Diagnostic Test|AI-based diagnosis|AI-based diagnosis will be performed based on analysis of endoscopic images (Olympus Optical, Tokyo, Japan). The investigators will use the Single Shot MultiBox Detector (SSD), a deep neural network architecture (https://arxiv.org/abs/1512.02325), and an optimal diagnostic cutoff from a prior report2. The AI system reviewed endoscopy images and reported those in which gastric cancer was detected, together with the coordinates (X, Y) of the lesions.
15850321|NCT04040374|Diagnostic Test|The expert endoscopists-based diagnosis|The expert endoscopists are two physicians with experience of more than 20,000 endoscopies. The expert endoscopists will review the endoscopy images of each patient for 5 min. They will then report endoscopy images in which gastric cancer was detected and manually annotate the lesions in those images.
15850322|NCT04040361|Drug|Pembrolizumab|Pembrolizumab will be administered as a dose of 200mg as a 30-minutes IV infusion, Q3W
15850323|NCT04040361|Drug|Ramucirumab|Ramucirumab will be administered as a dose of 10mg/kg as a 60-minutes IV infusion, Q3W
15850324|NCT04040361|Procedure|Surgery|Surgery to be performed is lobectomy or more extensive lung resection and lymph node dissection
15850325|NCT04040348|Biological|Approximately 100 million cells allogeneic hMSC|Umbilical cord-derived, allogeneic hMSC administered intravenously at a dose of approximately 100 million cells per infusion.
15850328|NCT04040309|Biological|PRGF injection|Plasma rich in growth factors will be prepared following the protocol described by E. Anitua. 9 ml of patients venous blood will be taken into one tube with 3,8% sodium citrate used as an anticoagulant. The blood then will be centrifuged (PRGF Centrifuge System, Biotechnology Institute, Vitoria, Spain) at room temperature for 8 min at 1800 rpm. After centrifugation 1 ml of 2nd plasma fraction will be collected by using a pipet. To activate plasma 10% calcium chloride will be used immediately before injecting plasma into the trigger point in the masseter muscle.
15850329|NCT04040309|Drug|Lidocaine injection|1 ml 2 % Lidocaine will be injected into the trigger point in the patient's masseter muscle.
15850330|NCT04040296|Other|Kidney Action Team Recommendations|Upon review of the patient's medical information, the Kidney Action Team will create personalized recommendations that will be delivered to the patient's primary care team via a specialized note in the electronic medical record system within 30 minutes of AKI development. The attending of record will be identified as a cosigner to ensure that a member of the care team is made aware of the note's presence.
15850331|NCT04040283|Procedure|Platelet-rich plasma (PRP) therapy|Platelet rich plasma (PRP) describes a technique in which platelets are isolated from a sample of a person's own blood using simple cell-separating systems such as centrifugation in order to obtain highly concentrated samples of platelets that can be re-injected into an injury site to promote healing.
15850332|NCT04040270|Behavioral|Live drama+DVD+Worksheets|"Interactive live drama was proposed to enhance memories of the audience of health promotion programmes.
~The interactive live drama and DVD conveyed educational information on healthy living habits (including physical activity and healthy eating) as well as the importance and suggested methods to enhance family well-being. Students were encouraged to share the information on healthy living habits and watched the DVD with their parents.
~Worksheets were given to all students and encouraged to finish the worksheets with their parents."
15850333|NCT04040270|Behavioral|DVD+Worksheets|"The DVD conveyed educational information on healthy living habits (including physical activity and healthy eating) as well as the importance and suggested methods to enhance family well-being. Students were encouraged to share the information on healthy living habits and watched the DVD with their parents.
~Worksheets were given to all students and encouraged to finish the worksheets with their parents."
15850334|NCT04040257|Behavioral|Team-based approach|Team-based participation in the The Perinatal Quality Foundation Fetal Monitoring Credentialing (PQF/FMC) exam.
15850335|NCT04040244|Other|Exhaled Breath Collection|Exhaled breath condensate (EBC) and exhaled breath volatiles (EBV) samples will be obtained over 5-10 minutes using a one-time use R-tube apparatus.
15850336|NCT04040244|Other|Blood sample|Blood samples collected simultaneously with routine standard of care blood draws.
15850337|NCT04040231|Biological|Galinpepimut-S|Galinpepimut-S will be administered alone on weeks 0 and 2. Participants will receive the galinpepimut-S vaccine and nivolumab over 16 weeks in the initial treatment phase.
15850338|NCT04040231|Drug|Nivolumab|Participants will receive nivolumab and the galinpepimut-S vaccine over 16 weeks in the initial treatment phase.
15850339|NCT04040231|Biological|Sargramostim|All participants will receive Sargramostim (GM-CSF) 70 mcg injected subcutaneously on days 0 and -2 of each cycle
15850340|NCT04040218|Procedure|Dry Needling|Dry needling is utilized by multiple practitioners to address impairments in neuromusculoskeletal function, often related to pain and loss of mobility. Dry needling, according the American Physical Therapy Association (APTA), is defined as a skilled intervention that uses a thin filiform needle to penetrate the skin and stimulate underlying myofascial trigger points, muscular, and connective tissues for the management of neuromusculoskeletal pain and movement impairments
15850341|NCT04040205|Drug|Abemaciclib|Abemaciclib 200 mg will be taken by mouth twice daily..
15850342|NCT04040192|Drug|Crisaborole 2%|Crisaborole ointment 2%
15850343|NCT04040192|Drug|Vehicle|Vehicle ointment
15850344|NCT04040166|Diagnostic Test|PET/MRI of carotid arteries with 68Ga DOTATATE|PET/MRI of carotid arteries with 68Ga DOTATATE in patients post head and neck radiation therapy
15850345|NCT04040153|Behavioral|Guiding Good Choices|Guiding Good Choices is a 5-session group-based prevention program for parents of early adolescents. Weekly 2.5 hour sessions will be held at participants' primary care clinics and led by two trained interventionists. Through didactic material, video segments, interactive activities, and home practice, the curriculum teaches parents to understand the progression from individual and environmental risk and protective factors to substance use and problem behavior, enhances parenting behaviors and skills, teaches effective family management skills, strengthens parent-adolescent interactions and bonding, broadens opportunities for family involvement, teaches conflict reduction and anger management skills, and teaches adolescents skills to resist peer influences to engage in risky behavior. Parents who opt not to attend groups will be offered a self-guided intervention manual containing the same core content and video access, plus supportive coaching to motivate use and address questions.
15850346|NCT04040140|Other|APA Treatment|Light touch using vaccaria seeds on corresponding ear points related to patient's pain.
15850347|NCT04040127|Biological|Cord blood stem cells|Umbilical cords are collected from eligible donors at the time of delivery and transported to the processing facility on ice (2-8℃) in Dulbecco's Modified Eagle Media (DMEM). Cords are processed immediately under aseptic conditions and MSCs are collected for culture. Culture is maintained this way until the target number of cells has been reached, at which point passaged cells are suspended in Stem Cellbanker (Amsbio, Cambridge, MA) and frozen at -80℃.
15850348|NCT04040127|Other|Saline solution|saline solution used to rinse the canal.
15850349|NCT04040114|Device|Molemap Skin Cancer Triage Artificial Intelligence Device|This device/software incorporates artificial intelligence to provide a diagnostic aide for clinicians of patients with potentially malignant skin lesions. The software is supported by the use of cameras for acquisition of images.
15850350|NCT04040101|Device|smartphone-based balance training system|use smartphone application to training balance
15850351|NCT04040088|Procedure|Computed Tomography|Undergo PET/CT
15850352|NCT04040088|Drug|Gallium Ga 68-DOTATATE|Given IV
15850353|NCT04040088|Procedure|Positron Emission Tomography|Undergo PET/CT
15850354|NCT04040075|Drug|Biktarvy Tab|Antiretroviral drug
15850418|NCT04039555|Device|Erbium-yag|Two sessions with Erbium-yag laser for vaginal symptoms treatment
15850419|NCT04039555|Device|CO2 intimate or Erbium-yag|Two sessions of one of the two lasers with no therapeuthical energy
15850355|NCT04040062|Device|Transcranial Magnetic Stimulation|Transcranial magnetic stimulation (TMS) is a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of depression. Using pulsed magnetic fields, transcranial magnetic stimulation therapy stimulates the part of the brain thought to be involved with mood regulation. These magnetic fields do not directly affect the whole brain; they only reach about 2-3 centimeters into the brain directly beneath the treatment coil.As these magnetic fields move into the brain, they produce very small electrical currents. These electrical currents activate cells within the brain, causing them to rewire, a process called neuroplasticity.
15850356|NCT04040049|Genetic|FLT190|Gene Therapy product.
15850357|NCT04040036|Behavioral|Children watch applications by wearing the virtual headset during the blood draw.|wearing the virtual headset
15850358|NCT04040023|Drug|Iron and vitamin Deficiencies Correction Program|"Preoperative:
~For patient with iron deficiency: Intravenous iron supplementation For patient with folic acid or vitamin B12 deficiency : oral vitamin supplementation For patient with anemia: pre operative erythropoietin injections
~Postoperative:
~Systematic iron supplementation"
15850359|NCT04040023|Other|PBMi: Training program to improve transfusion practices|Training program to sensitize health care staff to streamline the use of transfusion targeting the following points: limit perioperative and post operative hemodilution; to adapt the transfusion threshold to the tolerance of the patient to anemia in per and postoperative; justify the use of RBC transfusion by setting up a questionnaire; encourage transfusion of RBC unit by unit.
15850360|NCT04040010|Dietary Supplement|Colostrum supplementation for bone loss|Participants in the interventions groups (i.e. colostrum supplementation) will take a colostrum mixture for 5 months (5 times per week; a total of 250ml per day in liquid form). Participants in the placebo groups (i.e. controls) will be taking a placebo mixture (a total of 250ml per day in liquid form per dose) for the same period of time.
15850361|NCT04039997|Device|CPRMeter|teaching resuscitation with application of cpr feedback device
15850362|NCT04039997|Other|Manual chest compression|Manual chest compression
15850363|NCT04039984|Device|Prime Cup|Patients in this group will have the Prime cementless acetabular cup used during surgery.
15850364|NCT04039971|Procedure|ACL Reconstruction|Surgical techniques
15850365|NCT04039958|Drug|Soviredia|Test drug (Soviredia)1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir
15850366|NCT04039958|Drug|Harvoni (first dose)|Reference drug (Harvoni) 1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir
15850367|NCT04039958|Drug|Harvoni (Second dose)|Reference drug (Harvoni) 1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir
15850369|NCT04039919|Drug|Padsevonil|Padsevonil will be administered in predefined dosages.
15850370|NCT04039919|Drug|Placebo (PSL)|Placebo will be provided matching Padsevonil to maintain the blinding.
15850371|NCT04039906|Device|Removal of needle with using ANDYs|"ANDY will be provided to medical staffs to be use in removal needles from syringes during 7 days
~Record the time required for the needle removal procedure by photographing the needle removal procedure during 24 hours/7 days.
~Identify the number of syringes processed by ANDY.
~After 3rd week, do survey and interview 15 people selected by the convenient sample method. By interviewing, collect information of overall experience after using automated needle processing system, how long their hospital working experience is, and other information or systems the interviewees felt those are necessary."
15850372|NCT04039893|Diagnostic Test|Systematic axillary ultrasound imaging|Before surgery, all patients will be explored with a pre-defined systematic and reproducible axillary ultrasound imaging workflow intending to establish the number of neoplastic lymph nodes.
15850373|NCT04039893|Diagnostic Test|Sentinel node|Sentinel nodes will be identified with a radioisotope tracer and blue dye or fluorescein.
15850374|NCT04039893|Procedure|Excision of suspicious lymph nodes|Nodes suspected to be infiltrated both by physical exploration and/or ultrasound will be excised and evaluated separately.
15850375|NCT04039893|Procedure|Two steps axillary node clearance|Axillary node clearance will be performed in two steps comprising inferior and superior clearance. The second intercostobrachial nerve will be considered the limit defining the border between superior and inferior axilla.
15850376|NCT04039880|Drug|Olorofim|single oral dose (120 mg, 3.7 MBq)
15850377|NCT04039867|Drug|Oxaliplatin with Gemcitabine|Oxaliplatin will be given as an intravenous infusion over 60 minutes on Days 1 and 14 at a dose of 100 mg/m2 for each cycle. Gemcitabine (1000 mg/m2) will be given on days 1 and 14 as an intravenous infusion over 30 minutes immediately prior to Oxaliplatin.
15850378|NCT04039854|Drug|Isoflurane, Sevoflurane or Desflurane|"The volatile anaesthetic agent will be administered via inhalation, i.e. ventilation through alveolar membrane in lungs) during the maintenance of anaesthesia. During CPB the volatile anaesthetic agent will be administered through the oxygenator oxygen inflow of the CPB machine.
~The maintenance dose of the volatile anaesthetic agent will be titrated to doses deemed necessary in order to provide sufficient depth of anaesthesia and blood pressure.
~The administration of the volatile anaesthetic agent will be started after induction of anaesthesia and it will be ended at the end of surgery, before the patient is transferred to the CCU."
15850379|NCT04039854|Drug|Propofol|Patients will receive propofol only during the surgical procedure. The maintenance dose of the propofol infusion will be titrated to doses deemed necessary in order to provide sufficient depth of anaesthesia (titrated to a depth of anaesthesia with BIS 30-60) and mean arterial pressure (MAP) of 50-80mmHg by the treating anaesthetist.
15850380|NCT04039841|Diagnostic Test|Motor Imagery Test|"Imagined Timed Up and Go (iTUG) is the imagined version of the actual Timed Up and Go (rTUG) described above). It is possible to calculate the absolute value of the difference between the time of execution of the TUG imagined and actually executed. This difference is called isochrony index. The alteration of this isochrony index is correlated with the decrease in walking speed during the double task. This test is performed during the osteoporosis screening consultation.
~For patients who agree to participate in the FallMI study, the name and contact information of the attending physician will be collected during the same consultation.
~Standardised email will be sent to the attending physicians to collect the presence of falls and its consequences. They will be classified as fatal, severe, moderate and inconsequential."
15850667|NCT04037605|Drug|Ketoconazole Pill (also known as nizoral)|Ketoconazole pill is taken 4 times per inpatient visit
15850382|NCT04039815|Drug|Ascorbic acid-Vitamin B1-Hydrocortisone|intravenous Thiamine (200mg in 50 mL of 0.9% normal saline and was administered as a 30-min infusion every 12 hours for 4 days or until ICU discharge), plus Vitamin C (1.5g mixed in a 100-mL solution of normal saline and was administered as an infusion over 30 to 60 min every 6 hours for four days or until ICU discharge) as well as hydrocortisone 50mg every 6 hours (or other equivalent products) for 7 days
15850383|NCT04039815|Drug|Placebo|patients would receive 50mL 0.9% normal saline, 100 mL 0.9% normal saline with the same infusion rate and hydrocortisone dependent on the discretion of the attending physician
15850384|NCT04039802|Procedure|Single-stage surgery|In the test group, patients will be scheduled for bone-anchored hearing implant surgery using the single-stage procedure. The implant and abutment will be placed in one surgery.
15850385|NCT04039802|Other|Two-stage surgery|Two-stage surgery has already been performed, data will therefore be retrospectively collected
15850386|NCT04039789|Behavioral|Project active legs|Home program of exercises of lower extremities includes the performance of 4 exercises of lower extremities of progressive difficulty that must be carried out at home 5 days a week, twice a day and walking progressively until reaching the marked goal (150 min / week (30 minutes for 5 days a week)).
15850387|NCT04039789|Procedure|Usual care|Evaluation, cleaning, debridement, topical treatment (moist healing) and compressive therapy according to the recommendations for the treatment of chronic cutaneous ulcers of the Community of Madrid.
15850388|NCT04039776|Diagnostic Test|"Cone Beam Computed Tomography (CBCT)"|"Cone Beam Computed Tomography (CBCT), a machine that use a low dose of radiation compared to traditional CT systems, and allows the examination in supine and standing position knee . In this way, for the same patient it will be possible to calculate the bone indexes both in weight-bearing condition and in non-weight-bearing, comparing the values between them, to identify possible differences due to the influence of orthostatism."
15850389|NCT04039763|Device|Dexcom G6|Realtime Continous Glucose Monitoring
15850390|NCT04039763|Device|Self monitoring of blood glucose|Finger prick self monitoring of blood glucose
15850391|NCT04039750|Drug|antibiotic rinse with suction|antibiotic rinse with suction
15850392|NCT04039750|Procedure|suction only|no irrigation, suction only
15850393|NCT04039737|Drug|Qingpeng Ointment|Take Qingpeng ointment (produced by Tibet Qizheng Tibetan Medicine Co., Ltd.) and apply it evenly on the shoulder joints, wrist joints and palms of the upper limbs. Press for 20 minutes and have rehabilitation training afer 10 minutes.
15850394|NCT04039724|Drug|HCP0605 + HGP0816|
15850395|NCT04039724|Drug|HCP1305|
15850396|NCT04039711|Procedure|Vaginal self-sampling|The objective is to determine the non-inferiority of vaginal self-sampling compared with vaginal/cervical classical sampling, and evaluate the possibility of using it in all clinical situations indicating the prescription of such a procedure to screen for genital infections (GIs), sexually transmitted infections (STIs) and group B streptococcus (GBS) asymptomatic carriage in pregnant women.
15850397|NCT04039698|Other|Telemedicine|Telemedicine monitoring and teleconsultation by video calls
15850398|NCT04039698|Drug|Velpatasvir/Sofosbuvir|Velpatasvir 100mg / Sofosbuvir 400mg once a day for twelve weeks
15850399|NCT04039685|Other|Effects of an eight weeks aerobic exercise followed by an eight weeks de-training period on UCP1 gene of human white adipose tissue|The investigators evaluated the effects of an eight weeks aerobic exercise program and a following of eight weeks of a de-training period on UCP1 gene in previously non-regular exercisers healthy adult men
15850400|NCT04039685|Other|Effects of an eight weeks resistance exercise followed by an eight weeks de-training period on UCP1 gene of human white adipose tissue|The investigators evaluated the effects of an eight weeks resistance exercise program and a following of eight weeks of a de-training period on UCP1 gene in previously non-regular exercisers healthy adult men
15850401|NCT04039685|Other|Effects of an eight weeks combined (aerobic+resistance) exercise followed by an eight weeks de-training period on UCP1 gene of human white adipose tissue|The investigators evaluated the effects of an eight weeks combined (aerobic+resistance) exercise program and a following of eight weeks of a de-training period on UCP1 gene in previously non-regular exercisers healthy adult men
15850402|NCT04039672|Procedure|Skin biopsy|5mm skin metastasis or primary melanoma biopsy
15850403|NCT04039659|Device|Negative-pressure wound therapy (PICO)|After the selection of patients and the signing of the consent, patients will be randomized and the device will be placed to those who belong to the PICO group in the operating room.
15850404|NCT04039646|Combination Product|ERAS treatment|The ERAS group had an enhanced postoperative recovery protocol. The gastric content was aspirated via the nasogastric tube by the anesthesiologist at the end of the procedure, and the nasogastric tube was withdrawn in the operating room immediately after the patient had recovered from anesthesia. and also early feeding and move.
15850405|NCT04039633|Procedure|Burst Spinal Cord Stimulation|Burst stimulation utilizes complex programming to deliver high-frequency stimuli of a 40 Hz burst mode with 5 spikes at 500 Hz per spike delivered in a constant current mode
15850406|NCT04039633|Procedure|Sham spinal cord stimulation|A pulse generator is implanted, but no spinal cord stimulation is provided
15850407|NCT04039620|Other|Observational study, no interventions expected|No interventions are planned
15850412|NCT04039594|Device|VA ECMO|VA ECMO for cardiopulmonary support
15850413|NCT04039581|Other|Kinesio Taping|Kinesio Taping
15850414|NCT04039581|Other|Transcutaneous Electrical Nerve Stimulation (TENS)|TENS
15850415|NCT04039568|Behavioral|Health Enhancement Program (HEP)|This is the active control group of the study, where participants will be educated on health promotion, healthy diet, music, and exercise, but do not learn breathing techniques, or meditation.
15850416|NCT04039568|Behavioral|Sahaj Samadhi Meditation (SSM)|This is the experimental arm of the study, where participants will be trained in a form of meditation that may improve depressive symptoms.
15850417|NCT04039555|Device|CO2 intimate|Two sessions with CO2 intimate laser for vaginal symptoms treatment
15850420|NCT04039542|Other|Compassion focused therapy (CFT)|Compassion focused therapy (CFT) sessions (developed from cognitive behavioural therapies) to target underlying shame and self-criticism - 10 x 90 minute sessions
15850421|NCT04039529|Device|SCENERGY-guided Biopsy|Use of SCENERGY during a lung, liver or kidney biopsy
15850422|NCT04039516|Drug|Lutathera|A total of 4 infusions of Lutathera to be administered every 8 weeks.
15850423|NCT04039503|Drug|Tirzepatide|Administered SC as add-on to the pre-trial background medication.
15850424|NCT04039503|Drug|Placebo|Administered SC as add-on to the pre-trial background medication.
15850425|NCT04039490|Device|SCENERGY|Use of the SCENERGY guidance device in conjunction with ultrasound to guide needles for pediatric vessel cannulations
15850426|NCT04039477|Drug|KZR-616|Patients will receive KZR-616 SC once weekly. Patients assigned to Arm A will receive 30 mg for 13 weeks and patients assigned to Arm B will receive 30 mg for 1 week then 45 mg for 12 weeks
15850427|NCT04039464|Drug|Mono-Therapy with Sildenafil|The subjects will be randomized to receive sildenafil alone and will undergo study procedures as outlined in section 1.3. There will not be a placebo group.
15850428|NCT04039464|Drug|Duo-Therapy with Sildenafil + Bosentan|The subjects will be randomized to receive combination up-front therapy sildenafil and bosentan and will undergo study procedures as outlined in section 1.3. There will not be a placebo group.
15850429|NCT04039438|Other|No intervention|No intervention will be provided during the study nor participants will be receiving any intervention anywhere else.
15850430|NCT04039425|Procedure|Hair cut|Use only head hair. Cut samples of hair from back of head (see illustration). Cut hair as close to the scalp as possible. As each piece of hair is cut from the head, save only 3.7 square inches of hair closest to the scalp. According to the Doctors Data Lab, this amount is about enough hair to fill a tablespoon. Cut off and discard the rest. Place the saved hair on the scale. Keep cutting and adding hair to the scale until it tips. Hair collection will be about the weight of one to two paper clips (about 3800 strands). Remove the hair on the scale and put it in the plastic bag. Label the plastic bag with the patient's unique random identification and the date collected. Put the hair into the plastic bag, seal, and send to The Doctor's Data Lab.
15850431|NCT04039412|Drug|Hybrid regimen|two-step (dual-quadruple) treatment
15850432|NCT04039412|Drug|Reverse hybrid regimen|one-step two-phase (quadruple-dual) treatment
15850433|NCT04039412|Drug|Levofloxacin quadruple regimen|non-Clarithromycin non-Bismuth quadruple therapy
15850434|NCT04039399|Procedure|Ischemic Conditioning|Ischemic conditioning is a well-defined, non-invasive procedure which consists of inflating a blood pressure cuff around a limb (in our study, the paretic leg), inflating the cuff to 225 mmHg to occlude blood flow to the limb for 5 minutes, releasing the cuff for 5 minutes, and repeating 5 times. In our study, participants will receive one session of the intervention (45 minutes total).
15850435|NCT04039399|Procedure|Sham Ischemic Conditioning|There will also be an IC Sham group which is identical to the IC intervention, except the cuff is only inflated to 10 mmHg, which is a high enough pressure to perceive cuff tightness but not high enough to have any physiological effects.
15850436|NCT04039386|Device|Cell Phone Based Cognitive Based Therapy (Pacifica App)|Cell phone application that provides support for individuals with psychosocial conditions.
15850437|NCT04039386|Other|Control|Subjects in the control group will receive standard care.
15850438|NCT04039373|Drug|BMS-986256|specified dose on specified days
15850439|NCT04039373|Drug|Mycophenolate Mofetil|specified dose on specified days
15850440|NCT04039360|Combination Product|self-expanding metallic stent placement followed by neoadjuvant chemotherapy|Neoadjuvant chemotherapy was administered 1 week after successful SEMS placement and decompression for patient with obstructing left-sided colonic cancer. Patients received either three cycles of mFOLFOX6 repeated every 2 weeks or two cycles of CAPOX repeated every 3 weeks. Elective surgery was performed 2 weeks after completion of chemotherapy by experienced colorectal surgeons.
15850441|NCT04039347|Drug|Liposomal Cyclosporine A 5 mg|delivered via the PARI eFlow® device
15850442|NCT04039347|Drug|Liposomal Cyclosporine A 10 mg|delivered via the PARI eFlow® device
15850443|NCT04039334|Other|Conventional Chest Physiotherapy|Conventional chest physiotherapy programme will include diaphragmatic breathing exercise, thoracic expansion exercises, incentive spirometer exercise (Triflo), teaching of respiratory control, relaxing and coughing techniques.
15850444|NCT04039334|Other|Creative Dance Based Exercise Training|Creative dance based exercise training will be given under the supervision of a physiotherapist who takes creative dance instructor training 2 days and 60 minutes per week.
15850445|NCT04039321|Drug|ESPB group|USG probe will be placed in a longitudinal parasagittal orientation 3 cm lateral to T7 spinous process. The erector spinae muscles will be identified hyperechoic transverse process. The patient's skin will be anesthetized with 2% lidocaine. A 21-gauge 10-cm needle was inserted using an in-plane superior-to-inferior approach or an outplane approach. Following confirmation of the correct position of the needle with 5 ml normal saline, a dose of 20 ml %0.25 bupivacaine will be administered. The same procedure will be performed at the other site (totally 40 ml %0.25 bupivacaine). Standard pain follow up and monitorization will be performed.
15850446|NCT04039321|Drug|Control group|The patients in this group will be performed no block. Standard pain follow up and monitorization will be performed.
15850447|NCT04039295|Procedure|ultrasound guided caudal epidural block|dynamic ultrasound imaging of the spread of local anesthetics
15850448|NCT04039282|Device|myfood24|online website for dietary analysis
15850449|NCT04039269|Other|Preoperative video information|
15850450|NCT04039256|Device|percutaneous ventricular restoration using heartech® device|Patients who are confirmed suitability by imaging analysis, receive heartech® left ventricular partitioning device implantation.
15850451|NCT04039243|Behavioral|Being Brave|Up to 12 weekly sessions
15850452|NCT04039243|Other|Parent Education|Parents receive educational materials about helping children overcome shyness and fear
15850668|NCT04037605|Drug|Ganirelix|Ganirelix subcutaneous injection is administered twice per inpatient visit
15850455|NCT04039217|Drug|Biktarvy|Participants will be given 2 doses of the oral fixed dose combination anti-HIV medication Biktarvy (TAF/FTC/BIC) separated by 24 hours
15850456|NCT04039204|Drug|Elagolix|This orally active, reversible GnRH antagonist will be used to suppress endometriosis by lowering estrogen levels for 2 months prior to FET
15850457|NCT04039204|Drug|Oral Contraceptive|Oral contraceptive prescribed by physician.
15850458|NCT04039191|Behavioral|SMS education|Patients will receive additional educational SMS messages post-operatively
15850459|NCT04039191|Behavioral|SMS survey|Patients will receive survey questions about post-operative pain and opioid use but no education
15850460|NCT04039178|Device|BQ|The BQ device (BrainQ Technologies Ltd., Israel), a Brain Computer Interface based stimulation device, uses machine learning tools to identify high resolution spectral patterns associated with motor functions in EEG measurements of healthy/non healthy subjects. These patterns are then translated into a tailored frequency dependent low intensity, non-invasive electro-magnetic treatment protocol.
15850461|NCT04039178|Device|Sham|Sham BQ device
15850462|NCT04039165|Behavioral|PP-MI Intervention|The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walkability.
15850463|NCT04039152|Other|Clinical pharmacists recommendations to optimize antibiotics use|Optimal dosing, drug bug mismatch
15850464|NCT04039139|Behavioral|Mind Body Intervention 1|Mind body techniques for Intervention 1 will be taught in lectures and group discussion sessions.
15850465|NCT04039139|Behavioral|Mind Body Intervention 2|Mind body techniques for Intervention 2 will be taught in lectures and group and/or individual sessions.
15850466|NCT04039126|Drug|CHEMICAL PLEURODESIS WITH POVIDONE-IODINE-TETRACYCLINE COMBINATION|Pleurodesis is the obliteration of the pleural cavity by inducing adhesions of the visceral and parietal pleural layers, mostly used in patients with pleural effusions, pneumothorax (18). The use of pleurodesis to induce pleural symphysis between the pleural layers dates backs to the beginning of the 20th century by Benthune(19) and has continued to evolve with different Thoracic surgeons and researchers still looking for the ideal pleurodesis agent.
15850467|NCT04039126|Drug|CHEMICAL PLEURODESIS WITH POVIDONE-IODINE ALONE|20mls of 10% povidone-iodine (Wosan Solution Povidone-Iodine Usp 10%, Jawa International Limited) is mixed with 10mls of 1% xylocaine and 30mls of water for injection added to the mixture, making also a total volume of 60mls of the the single pleurodesis agents alone, which will be instilled into the pleural space via the closed thoracotomy tube.
15850468|NCT04039113|Biological|Tezepelumab|Tezepelumab subcutaneous injection
15850469|NCT04039113|Other|Placebo|Placebo subcutaneous injection
15850470|NCT04039100|Other|Family Caregiver Ambassador Support|Family Caregiver Ambassador Support, with former caregivers of patients treated for hematological malignancies, being ambassadors for caregivers of newly diagnosed patients for a period of 12 weeks
15850471|NCT04039087|Drug|Sildenafil 40mg oral capsule|40 mg, sildenafil capsule taken by mouth thrice daily
15850472|NCT04039087|Drug|Placebo Oral capsule|Placebo capsule taken by mouth thrice daily
15850473|NCT04039074|Behavioral|Integrative Yoga|"A 12-week Integrative Yoga intervention which has meditative and psycho-educational components corresponding to traditional yoga practice."
15850474|NCT04039074|Behavioral|Iyengar Yoga|A 12-week established, predominantly body-oriented yoga intervention (Iyengar yoga).
15850475|NCT04039074|Behavioral|Mindfulness|A 12-week mindfulness intervention designed for the healthy handling of stress.
15850476|NCT04039048|Device|cerebellar transcranial direct current stimulation|Non-invasive brain stimulation technique is able to modulate the brain activity through a low-intensity current. The anodal will be positioned 1 cm below inion and cathodal in the right deltoid muscle. 20 minutes with a 2mA current.
15850477|NCT04039048|Device|Sham cerebellar transcranial direct current stimulation|Non-invasive brain stimulation technique is able to modulate the brain activity through a low-intensity current. The anodal will be positioned 1 cm below inion and cathodal in the right deltoid muscle. 30 seconds with a 2mA current.
15850478|NCT04039048|Other|Balance training|Balance training will be performed through the Biodex Balance System for 20 minutes.
15850480|NCT04039009|Diagnostic Test|Pelvic Organ Prolapse Quantification system|The Pelvic Organ Prolapse Quantification system assessment tool measures nine anatomical points and distances in the vagina. The hymen is the reference point to which the other points are compared. The prolapsed organs are measured in centimeters to the hymen with an examination ruler.
15850481|NCT04038970|Biological|KN019, 5mg/kg|Solution, intravenous, 5 mg/kg
15850482|NCT04038970|Biological|KN019, 10 mg/kg|Solution, intravenous, 10 mg/kg
15850483|NCT04038970|Biological|Placebo|Solution, intravenous, Placebo
15850484|NCT04038970|Combination Product|Methotrexate|Tablets, oral, 7.5-25 mg weekly to be adjusted according to patient condition
15850485|NCT04038957|Drug|SEP-363856|SEP-363856 50mg, 75mg flexable dosing, dosed once daily capsule
15850486|NCT04038931|Other|Liver biopsy collection|Liver biopsy collection to Confirm suitability of T1DM, total or partial pancreatectomy patient's liver cells to be used as future personalized cell replacement therapy.
15850487|NCT04038918|Other|progressive muscle relaxation exercise|In addition to standard postoperative rehabilitation, intervention group will receive PMR exercises focusing on reduce overall body tension, anxiety. The intervention group will perform the PMR exercise in accompanying with a qualified physiotherapist for postoperative 3 days (2 times/day; along 30 minutes for one session).
15850488|NCT04038918|Other|standard postoperative physiotherapy program|After surgery, patients will receive standard postoperative rehabilitation program including active-assistive and active range of motion exercises, isometric and isotonic strengthening exercises, gait training and transfer training.
15850489|NCT04038892|Other|Conventional Chest Physiotherapy|Programme will include diaphragmatic breathing exercise, thoracic expansion exercises, incentive spirometer exercise (Triflo), oscillatory PEP (Flutter), postural drainage, coughing techniques and teaching respiratory control.
15850490|NCT04038892|Other|Nintendo Wii Fit Based Exercise Training|Nintendo Wii Fit based exercise training will be given under the supervision of a physiotherapist. The one session will be included: warm-up exercises for 5 minutes (yoga games; deep breathing and half moon etc.), aerobic exercises for 30 minutes (aerobic games; Twisting and Squat, Step Plus, Jogging Plus and Hula Hoop etc.) and cooling exercises in 5 minutes (yoga games; deep breathing and half moon etc.).
15850491|NCT04038892|Other|BreathingLabs Breathing Games Based Exercise Training|BreathingLabs Breathing Games based exercise training will be given under the supervision of a physiotherapist. The one session will be included: warm-up exercises for 5 minutes (respiratory control exerice and coughing techniques), breathing games exercises for 30 minutes (breathing games; Kite, Balloon, Pluto, Butterflies and Plane etc.) and cooling exercises in 5 minutes (respiratory control exerice and coughing techniques).
15850492|NCT04038879|Diagnostic Test|MRI|MRI of the heart
15850493|NCT04038866|Other|rehabilitation gait with dual task|
15850494|NCT04038866|Other|rehabilitation gait without dual task|
15850495|NCT04038853|Drug|1,25-Dihydroxyvitamin D|1,25-dihydroxy-vitamin D3 1000 IU orally daily for 12 months
15850496|NCT04038853|Drug|Placebo|Placebo identical to the study intervention drug
15850497|NCT04038840|Drug|[11C]UCB-J radiotracer|I.V. bolus administration of up to 15 mCi (equivalent to 0.3 rems) in the antecubital vein
15850498|NCT04038840|Device|PET-MR|Positron emission tomography and magnetic resonance imaging, with a scan duration of up to 120 minutes
15850499|NCT04038827|Diagnostic Test|D-CEC counting|By means of preliminary bulk separation step with the CellSearch system, single CEC will be sorted
15850500|NCT04038814|Procedure|Routine prevention of VAP|Enhanced hand hygiene protocol, tube cuff pressure monitoring ( set on 25-30 mm Hg) every 12 hours and every time when we suspected under or over distention, fast withdrawal of sedation, moderate supportive mechanical ventilation ( tidal volume (VT) 5-8 ml/kg ideal body weight (IBW), positive end expiratory pressure (PEEP) 3-5 cmH2O, Plateau pressure (Ppl) < 25 cm H2O, normocapnia ), Proton Pump Inhibitors (PPIs) reduction, Selective oral decontamination (SOD) every 8 hours - 0,2% chlorhexidine digluconate mouthwash, Closed Tracheal Suction System (CTSS) - changed every 7 day, 30-45% lifting of the thorax
15850501|NCT04038814|Procedure|Modified prevention of VAP|"3 modifications of the routine bundle in the prevention of VAP:
~Endotracheal tube ( Shiley Evac Endotracheal tube with TaperGuard Cuff) and tracheostomy tubes (Tracheostomy Tube Cuffed Seal Guard) instead of regular tubes,
~Automatic, continuous tube cuff pressure monitoring ( Covidien Shiley M Pressure Control Automatic Cuff Controller ( 25-30 mmHg),
~Automatic continuous subglottic secretion drainage"
15850502|NCT04038801|Procedure|Quadrant-wise scaling and root planning (Q-SRP)|Quadrant-wise scaling and root planing were performed by assortment of manuel periodontal curettes over four visits at 1-weekly intervals.
15850503|NCT04038801|Procedure|Full-mouth ultrasonic debridement (FMUD)|Subgingival debridement were performed by a piezoceramic ultrasonic inserts in two visits of the same day.
15850504|NCT04038801|Procedure|Full-mouth disinfection (FMD)|Subgingival debridement were performed by a piezoceramic ultrasonic inserts and an intensive regime of chlorhexidine in two visits of the same day.
15850505|NCT04038788|Device|HD hf-tRNS|See detail in arm/group descriptions regarding the intervention.
15850506|NCT04038775|Behavioral|Volunteering|Subjects recommended volunteer by their provider.
15850507|NCT04038762|Procedure|cuff deflation-inflation -deflation method|Nasotracheal intubation placed with video-laryngoscopy assistance, via the tracheal tube cuff inflation-deflation method with or without the aid of Magill forceps
15850508|NCT04038749|Drug|Bromocriptine|Bromocriptine - on the first day of treatment (1,25 mg) with morning and evening meal and then 2,5 mg dose twice a day for two weeks (14 days)
15850509|NCT04038749|Drug|Cabergoline|Cabergoline - one dose (1 mg) on the first day after childbirth or 0.25 mg dose every 12 hours for 2 days
15850510|NCT04038749|Other|Natural methods|milk expression, cold compress, cabbage leaf compresses, mild painkiller- e.g. ibuprofen, supportive bra, sage tea.
15850511|NCT04038736|Device|C-Scan System|During C-Scan procedure the subject swallows the C-Scan cap. The capsule travels painlessly through the gastrointestinal tract, seeking polyps, the precursors of colorectal cancer. It is essential to increase the stool's contrast by ingesting radio-opaque material. During the passage of the capsule in the gastrointestinal tract, it transmits information to a recorder attached to the back. In order to collect data about the instantaneous localization of the capsule traveling in the colon additional sensors are embedded in the recorder on the back side. After the capsule is expelled, the data from the recorder is downloaded to an acquisition workstation. Later, the data is transferred to a processing workstation where dedicated software visualizes and analyses the data.
15850512|NCT04038723|Behavioral|High-intensity interval training|Cardiac patients have completed 36 times of exercise training with the exercise frequency of 2-3 times per week. Subjects performed five 3-minute intervals at 80% of VO2peak and each interval was separated by 3-minute exercise at 40% of VO2peak after the warm-up period. The exercise session was terminated by 3-minute cool-down at 30% of VO2peak.
15850513|NCT04038710|Drug|Triple combination therapy|Triple combination is compromised of the drugs ivacaftor, tezacaftor and Vertex's next generation modulator.
15850514|NCT04038697|Procedure|Ischemic Conditioning|Ischemic conditioning is a well-defined, non-invasive procedure which consists of inflating a blood pressure cuff around a limb (in our study, the paretic leg), inflating the cuff to 225 mmHg to occlude blood flow to the limb for 5 minutes, releasing the cuff for 5 minutes, and repeating 5 times. In our study, participants assigned to the IC Only and IC + Treadmill Training groups will undergo twelve sessions of ischemic conditioning over a four-week period.
15850515|NCT04038697|Procedure|Ischemic Conditioning Sham|Ischemic conditioning sham consists of the same setup as ischemic conditioning, which consists of inflating a blood pressure cuff around a limb (in our study, the paretic leg), inflating the cuff to 10 mmHg for 5 minutes, releasing the cuff for 5 minutes, and repeating 5 times. 10 mmHg is a sufficient inflation pressure for study participants to perceive some cuff tightness, but is not high enough to occlude blood flow. In our study, participants assigned to the IC Sham + Treadmill Training groups will undergo twelve sessions of ischemic conditioning sham over a four-week period.
15850538|NCT04038541|Dietary Supplement|Probiotics (Visbiome®)|"Commercially available Probiotics Visbiome extra strength, which is a combination of live lactic acid bacteria probiotics that have been cultivated, freeze-dried and mixed in very high concentrations.
~2 packets (450 billion CFU), Twice Daily (Total of 3,600 billion Daily)"
15850516|NCT04038697|Procedure|Treadmill Training|Participants will perform 3 treadmill training sessions/week for a 4 week period (12 sessions total). Treadmill training will immediately follow IC or IC Sham. Personnel performing the treadmill training will be blinded to the IC treatment group. Subjects will walk on a treadmill for six, 5-minute intervals. Walking speed will be continuously adjusted to maintain heart rate between 50% and 60% of age-adjusted heart rate reserve to minimize the confounder of intensity. If individuals cannot walk at 80% of their overground self-selected walking speed, for 5 minutes, they will be assisted into a body weight support harness. Body weight support will be adjusted (up to 50%) such that individuals can walk at 80% of their over ground walking speed for five minutes and adjusted accordingly throughout the session. Participants assigned to the Treadmill + IC and Treadmill + IC Sham groups will receive Treadmill Training.
15850517|NCT04038684|Behavioral|Mindfulness-Based Weight Control (MBWC)|Mindfulness-Based Weight Control will be administered over 16 group-based sessions with weekly home practice (mindfulness exercises, dietary self-monitoring, physical activity). Sessions will include Standard Behavioral Weight Control (SBWC) and mindfulness components. SBWC components include: 1) a dietary plan based on a balanced, reduced caloric deficit diet; 2) incrementally increasing physical activity; 3) behavioral components (e.g. self-monitoring, goal setting, stimulus control); and 4) minimal parent involvement (i.e., 3 parent sessions). Participants will be taught core mindfulness exercises (e.g. breath-awareness, body scan, mindful eating) while focusing attention on the present moment and non-judgmentally acknowledging thoughts, emotions, or sensations. Participants will learn informal mindful strategies for daily living, which are designed to increase awareness of pleasant and unpleasant emotions and the relation to habitual behaviors (e.g. emotional eating).
15850518|NCT04038684|Behavioral|Standard Behavioral Weight Control (SBWC)|Standard Behavioral Weight Control will be administered over 16 group-based sessions with weekly home activities (dietary self-monitoring, physical activity). Group sessions will include SBWC component, including: 1) a balanced, reduced caloric deficit diet; 2) incrementally increasing physical activity; 3) behavioral components (e.g., self-monitoring, goal setting, stimulus control, motivation, problem-solving, etc.); and 4) minimal parent involvement (i.e., 3 parent sessions).
15850519|NCT04038671|Device|Activated Carbon Cloth Dressing|Patients will return for weekly follow-up evaluations the first four weeks following surgery and then will return for a final evaluation eight weeks postoperatively. Incision dressings will be changed by the investigator or the investigator's nursing staff at each weekly visit to assess for incision closure and post-surgical wound complications.
15850520|NCT04038671|Device|Knitted Cellulose Acetate Mesh|Patients will return for weekly follow-up evaluations the first four weeks following surgery and then will return for a final evaluation eight weeks postoperatively. Incision dressings will be changed by the investigator or the investigator's nursing staff at each weekly visit to assess for incision closure and post-surgical wound complications.
15850521|NCT04038671|Device|Antimicrobial Alginate Dressing with Silver|Patients will return for weekly follow-up evaluations the first four weeks following surgery and then will return for a final evaluation eight weeks postoperatively. Incision dressings will be changed by the investigator or the investigator's nursing staff at each weekly visit to assess for incision closure and post-surgical wound complications.
15850522|NCT04038658|Behavioral|Move-It|
15850523|NCT04038645|Other|Experimental group (laser)|"The patients will receive infrared LEDs in 6 points using a mask developed for the research . The irradiations will be performed with red LED ( wavelength = 660 nm) with output power of 100 milliwatt. During application of the LED both patient and operator will wear goggles.
~The red diode laser will be used. The power of the device is 100 mW and the wavelength used was 660nm (± 10nm). The diameter of the fiber optic of the apparatus has 600 μm, therefore a spot (area) of 0.002826cm2. The energy delivered per point is 1 Joule. 10 seconds of application is required. As 6 points are irradiated, the total energy delivered is 6 Joules. The energy density is 354 J / cm2 and the power density would be 35.4 W / cm2. The points will be determined by the same operator, obeying the protocol."
15850524|NCT04038645|Other|Control group (Placebo)|Patients will receive the LED at the same points recommended for the experimental group, but will be off. So that the patient does not identify the sound of activation of the device (beep), it will be recorded, and connected at the time of the application of the laser. The questionnaire to assess the impact of treatment on quality of life will be applied at baseline and after 8 days as well as the evaluation of serum CRP.
15850525|NCT04038632|Other|Decentralization of Childhood TB Diagnosis|The patient care level TB diagnostic approach consists of systematic TB screening, clinical evaluation, NPA and stool or sputum testing using Xpert Ultra, and optimised CXR reading will be implemented at DH and PHC levels
15850526|NCT04038619|Procedure|Fecal Microbiota Transplantation|Undergo FMT via colonoscopy
15850527|NCT04038619|Drug|Loperamide|Given PO
15850528|NCT04038606|Other|Determination of acceptance and / or rejection of mastectomy|Blood exams,Participants completed a questionnaire translated in French language : Rosenberg,SF-36, QLQC30, Big Five Inventory,BPI-SF.:-)
15850529|NCT04038593|Other|Youtube© relaxation music|Use of non standardized relaxation music with Youtube© during cares
15850530|NCT04038593|Device|MUSIC CARE© intervention|Use of MUSIC CARE© during cares
15850531|NCT04038580|Device|Laminated Socket|This is the currently prescribed socket the participant normally wears.
15850532|NCT04038580|Device|Socket-less Socket|The Socket-less Socket (MartinBionics) is one of three commercially available adjustable sockets used in this study that will be fit by a certified prosthetist.
15850533|NCT04038580|Device|Infinite Socket|The Infinite Socket (LiM Innovations) is one of three commercially available adjustable sockets used in this study that will be fit by a certified prosthetist.
15850534|NCT04038580|Device|CJ Socket|The CJ Socket (CJ Socket Technologies) is one of three commercially available adjustable sockets used in this study that will be fit by a certified prosthetist.
15850535|NCT04038567|Behavioral|Mobile mindfulness-based training|The intervention core is a mobile app-based mindfulness training program designed to be used over a 1-month period. All 8 factorial groups will use the app, though the delivery of the app and response to psychological distress symptoms over time will differ by group.
15850536|NCT04038554|Diagnostic Test|Feces and saliva analysis|Qualitative and quantitative analysis of the microbiota in the feces and saliva by mRNA sequencing.
15850537|NCT04038541|Dietary Supplement|Prebiotics (Prebiotin Prebiotic Fiber Stick Pac)|"Commercially available Prebiotin Prebiotic.
~2 packets (Inulin 4000 mg), Twice Daily (Total of 16 g Daily)"
15850539|NCT04038528|Behavioral|telemonitoring of T2DM|"Baseline record of:
~Weight
~Height
~BMI
~Abdominal circumference
~Winsor Index
~ECG
~Retinography
~Blood level of (fasting values): total cholesterol, HDL cholesterol, LDL cholesterol, blood sugar, triglycerides, glycated hemoglobin These parameters will be checked again at 3, 6 and 18 months in the two groups.
~Telemedicine group (intervention):
~Blood sugar (two measurements per week).
~Body weight (weekly)
~Blood pressure (weekly) Use of devices that allow the automatic upload of data via wi-fi or web is allowed
~Control group (control):
~Routine appointments scheduled by their GPs and specialists in outpatient clinics to record blood sugar levels as per standard GP or specialist physician's indications.
~Blood sugar level is measured in mg/dl in a drop of capillary blood with the use of standard glucose meter"
15850540|NCT04038515|Drug|Nicotine 0 mg/mL|E-liquid containing no nicotine (0 mg/mL nicotine) will be self-administered via e-cigarettes. This will be administered in 5 flavor conditions (1 unflavored, 2 menthol, and 2 fruit conditions).
15850541|NCT04038515|Drug|Nicotine 6 mg/mL|E-liquid containing low nicotine (6 mg/mL nicotine) will be self-administered via e-cigarettes. This will be administered in 5 flavor conditions (1 unflavored, 2 menthol, and 2 fruit conditions).
15850542|NCT04038515|Drug|Nicotine 12 mg/mL|E-liquid containing medium nicotine ( 12 mg/mL nicotine) will be self-administered via e-cigarettes. This will be administered in 5 flavor conditions (1 unflavored, 2 menthol, and 2 fruit conditions).
15850543|NCT04038515|Drug|Nicotine 24 mg/mL|E-liquid containing high nicotine ( 24 mg/mL nicotine) will be self-administered via e-cigarettes. This will be administered in 5 flavor conditions (1 unflavored, 2 menthol, and 2 fruit conditions).
15850544|NCT04038515|Other|'Menthol' flavor|E-liquid containing 'menthol' flavor will be self-administered via e-cigarettes. This will be administered in 4 nicotine conditions (0, 6, 12, 24 mg/mL nicotine).
15850545|NCT04038515|Other|'Menthol/Mint' flavor|E-liquid containing 'menthol/mint' flavor will be self-administered via e-cigarettes. This will be administered in 4 nicotine conditions (0, 6, 12, 24 mg/mL nicotine).
15850546|NCT04038515|Other|'Green Apple' flavor|E-liquid containing 'green apple' flavor will be self-administered via e-cigarettes. This will be administered in 4 nicotine conditions (0, 6, 12, 24 mg/mL nicotine).
15850547|NCT04038515|Other|'Watermelon' flavor|E-liquid containing 'watermelon' flavor will be self-administered via e-cigarettes. This will be administered in 4 nicotine conditions (0, 6, 12, 24 mg/mL nicotine).
15850548|NCT04038515|Other|'Unflavored'|E-liquid containing no additional flavor (i.e., 'unflavored') will be self-administered via e-cigarettes. This will be administered in 4 nicotine conditions (0, 6, 12, 24 mg/mL nicotine).
15850549|NCT04038502|Drug|Carboplatin|Chemotherapy FDA approved drug used to treat: ovarian, lung, head and neck cancers. It is sometimes used in combination with other medications or off-label use to treat other metastatic cancers.
15850550|NCT04038502|Drug|Olaparib|Olaparib is a targeted therapy drug that is used for mCRPC and is approved by the FDA for this use.
15850551|NCT04038489|Drug|Aspirin|325 mg aspirin daily during AC-T chemotherapy
15850552|NCT04038489|Drug|Tamoxifen Pill|Tamoxifen (either 20 mg daily or 10 mg twice a day) during AC-T chemotherapy
15850553|NCT04038489|Drug|Doxorubicin|Doxorubicin (60 mg/m2) Given by IV with cyclophosphamide
15850554|NCT04038489|Drug|Cyclophosphamide|Cyclophosphamide (600 mg/m2) Given by IV with doxorubicin
15850555|NCT04038489|Drug|Paclitaxel|Paclitaxel 80 mg/m2 or 175 mg/m2 based on provider preference. Given by IV after completion of doxorubicin/cyclophosphamide therapy
15850556|NCT04038476|Diagnostic Test|Standard monitoring + transcutaneous CO2 monitoring|The transcutaneous CO2 Monitoring measures the CO2 partial pressure of the skin and in condition of good circulation these values approximate the arterial/venous CO2 partial pressure. The sensor is placed on the forehead. The physician adapts the sedation Management according to the transcutaneous CO2 monitoring.
15850557|NCT04038476|Diagnostic Test|Standard monitoring|The transcutaneous CO2-sensor is also positioned on the patients' forehead, but the transcutaneous CO2-monitoring is not available for the physician to adapt the sedative management.
15850558|NCT04038463|Behavioral|EFP|This intervention will take place on day 4 of the participants' menstrual cycle. This will correspond to the mid-point of the early follicular phase (EFP).
15850559|NCT04038463|Behavioral|LFP|The intervention will take place on day 8 of the participants' menstrual cycle. This will correspond to the mid-point of the late follicular phase (LFP).
15850560|NCT04038463|Behavioral|ELP|The intervention will take place on day 18 of the participants' menstrual cycle. This will correspond to the mid-point of the early luteal phase (ELP).
15850561|NCT04038463|Behavioral|LLP|The intervention will take place on day 25 of the participants' menstrual cycle. This will correspond to the mid-point of the late luteal phase (LLP).
15850562|NCT04038450|Other|No intervention|No interventions separated the groups. Each group reviewed pictures and wrote down their estimated ROM of the joint pictured.
15850563|NCT04038437|Drug|CPX-351|CPX-351 will be administered on Days 1 and 3 of each cycle
15850564|NCT04038437|Drug|Venetoclax|Venetoclax will be adminstered on Days 2 to 21 of each cycle
15850565|NCT04038424|Other|Art therapy|Art therapy including coloring, painting and listening to music
15850566|NCT04038411|Drug|PD-1 Antibody, chidamide, lenalidomide and etoposide|PD-1 blocking antibody inhibits PD-1. Chidamide is an histone deacetylase inhibitor. Lenalidomide is a potent inhibitor of TNF-α. Etoposide inhibits DNA synthesis by forming a complex with topoisomerase II and DNA.
15850567|NCT04038398|Procedure|Non-invasive ventilation with different FiO2 settings|CPAP therapy applied with different order of FiO2 settings.
15850568|NCT04038385|Behavioral|Multilevel Behavioral Intervention|Behaviorally-focused intervention grounded in the Social Ecological Model and Social Cognitive Theory to promote vegetable intake and the redemption of seasonal Farmers' Market Nutrition Program vouchers and monthly Cash Value Vouchers provided to WIC participants to purchase fruits and vegetables.
15850569|NCT04038359|Drug|Duvelisib|PI3K Inhibitor
15850570|NCT04038346|Drug|Naproxen|Patients will be randomized to an NSAID (naproxen)
15850571|NCT04038346|Drug|Acetaminophen|Patients will be randomized to acetaminophen
15850572|NCT04038333|Other|No intervention|This is an observational study without any interventions.
15850601|NCT04038099|Drug|lidocaine topical|5cc 2% lidocaine jelly applied intraurethral
15850669|NCT04037605|Drug|Dexamethasone Pill|Dexamethasone pills is taken twice per inpatient visit
15850573|NCT04038320|Drug|Sofosbuvir/ledipasvir (SOF/LDV)|"SOF/LDV (400mg/90mg) orally once daily with or without food in the morning and will receive treatment for a duration of 12 weeks.
~In addition, Ribavirin weight-based (1000 mg for patients <75 kg and 1200 mg for those ≥75 kg) administered orally in two divided doses with food for Genotype 3 patients."
15850574|NCT04038307|Drug|paracetamol|1gm
15850575|NCT04038307|Drug|Saline Solution|100ml
15850576|NCT04038294|Dietary Supplement|ISOlution protein supplement|EXPERIMENTAL ARM: Protein supplement to be re-constituted and consumed twice daily for a minimum of 2 weeks pre-procedure, twice daily during post-operative recovery and 2 times daily for 8 weeks after the patient is discharged home.
15850577|NCT04038294|Dietary Supplement|Placebo Supplement|PLACEBO COMPARATOR ARM: Placebo supplement to be re-constituted and consumed twice daily for a minimum of 2 weeks pre-procedure, twice daily during post-operative recovery and 2 times daily for 8 weeks after the patient is discharged home
15850578|NCT04038281|Other|Sensory tests|Fat, bitter taste sensitivity and food preference measurement
15850579|NCT04038255|Drug|Nicoderm C-Q Transdermal Product|6 weeks of nicotine replacement therapy patches
15850580|NCT04038255|Behavioral|Orientation session|This session will occur 2 weeks before quit date. It will be moderated by a certified instructor in MT, and will last approximately 90 min. During the session, participants will learn the purpose, format, and procedures of the study, provide written informed consent, and complete the baseline assessment.
15850581|NCT04038255|Behavioral|Craving-to-Quit app|The app is comprised of 22 modules for 22 days, 5-15 minutes each, designed to teach MT using audio, video, and animation. The app also includes other features such as social support (quit friend sign-ups, the tip of the week), activity feed (to track interaction with the app), and my morning stats (to track smoking).
15850582|NCT04038255|Behavioral|Two brief follow-up phone calls|The first phone call will occur one day before the quit date to remind participants about their quit date and provide support. The second will occur at the end of treatment (around day 60 after quit date) to review progress, provide support, and schedule the 3-month follow-up visit. Each phone call will last approximately 15 minutes.
15850583|NCT04038255|Behavioral|Group MT sessions|Total of eight group sessions (twice a week) during 4 weeks. The overarching theme of momentary awareness and acceptance of cravings and affect (e.g., stress, anxiety etc.) will be introduced and reinforced in complementary ways throughout the training. Each session will last 45-60 minutes.
15850584|NCT04038255|Behavioral|Brief advice on quitting smoking|Standard advice on how to quit smoking.
15850585|NCT04038255|Behavioral|Self-help smoking cessation materials|Written materials on how to quit smoking including contact info for state tobacco quitline.
15850586|NCT04038242|Other|Resilience promotion program|Resilience Promotion Program consists of eight sessions. Except the first orientation session and the last review session, other six sessions focus on cultivating the five internal resiliency factors (physical, behavioral, cognitive, emotional and spiritual). There are two sessions for behavioral factor, including one special to deal with the relationships between parents and children.
15850587|NCT04038229|Other|Enhanced recovery pathway|The applied protocol include psychological screening for yellow flags, preoperative gabapentin, peroperative multimodal preemptive management and postoperative holistic evaluation short -and long term
15850588|NCT04038216|Procedure|Single-stage surgery|the bone-anchored hearing implant will be inserted in one surgery
15850589|NCT04038216|Other|Two-stage surgery|Two-stage surgery has already been performed, data will therefore be retrospectively collected
15850590|NCT04038203|Device|Resonance Raman Spectroscopy (RPS)|RRS is a technology that utilizes vibrational spectroscopy, rather than absorbance spectroscopy, to determine the oxyhemoglobin concentration in tissues. Raman measurements for the UAC neonates will be obtained simultaneously on the right AND left lower extremity for 15 minutes daily in the first week of life.
15850591|NCT04038190|Behavioral|behavioral activation|Behavioral activation (BA) is an intervention that indirectly addresses psychopathy by guiding individuals to identify goals in their lives, and encouraging individuals to engage in reinforcing activities that align with their goals (Lejuez et al, 2001). While initially used to treat depression, BA has been efficaciously applied to substance use because BA acts on the same reinforcement system common to many disorders (Daughters et al., 2018).
15850592|NCT04038177|Behavioral|Superset strength training|Three weeks of familiarization (two times per week) to the exercises leg-press, bench press, lateral pulldown and seated rows, followed by superset strength training two days per week for 12-weeks. Superset 1 are bench-press and seated rows, and superset 2 are leg-press and lateral pulldown. Each superset is performed three times.
15850593|NCT04038177|Behavioral|Traditional strength training|Three weeks of familiarization (two times per week) to the exercises leg-press, bench press, lateral pulldown and seated rows, followed by strength training two days per week for 12-weeks. Each exercise is performed for three sets with rest intervals between each set.
15850594|NCT04038164|Behavioral|Dog-Assisted Therapy and pharmacological treatment|The investigators used the CTAC Method (Center of Dog Assisted Therapy) (E Domènec 2012).
15850595|NCT04038151|Device|Hybrid Leg|The Hybrid Knee uses an actively variable transmission in combination of a passive spring/damper system. This allows the motor torque output to be adapted to the requirements of active dynamic tasks - changing the effective transmission ration from zero (fully passive) for level ground walking to a maximum value (fully active) for sit-to-stand transfers. This provides physiological knee torque and speed with a small motor and primary transmission system while also maximizing electrical efficiency, which minimized battery weight. The knee prototype weights 1.7kg. The Semi-active ankle can actively reposition during non-weight bearing phases of gait and uses a non back driveable transmission to maintain its set point during weight bearing activities.
15850596|NCT04038151|Device|Prescribed Passive Prosthesis|Participants will participate in training sessions of community skills and advanced ambulation training for their home, prescribed passive prosthesis.
15850597|NCT04038138|Diagnostic Test|Validation of FSHD in French as COA|FSHD Genetically confirmed FSHD1 or clinical diagnosis of FSHD with characteristic findings on clinical examination and an affected parent or offspring
15850598|NCT04038125|Drug|Ozurdex Drug Implant Product|Intravitreal Ozurdex injection
15850599|NCT04038112|Other|psychological therapy Method of Levels (MOL)|Transdiagnostic, cognitive psychological therapy Method of Levels (MOL)
15850600|NCT04038099|Drug|Water-Based Vaginal Lubricant|5cc water based jelly applied intraurethral
15850602|NCT04038086|Diagnostic Test|oral glucose tolerance test|Participants will undergo an 75 gram oral glucose tolerance test. Blood and CSF will be collected in the fasting state before the test and every 30 minutes throughout the test which lasts for 2 hours.
15850603|NCT04038086|Other|circadian rhythm|Blood and CSF will be collected five times throughout the day.
15850604|NCT04038086|Drug|effect of insulin on peptide transport|Blood and CSF will be collected in the fasting state and 15, 30, 60, 120 und 240 min after administration of 160 U of human insulin as nasal spray.
15850605|NCT04038073|Diagnostic Test|Antistreptolysin O Test|Test to evaluate of any histories of streptococcal infections
15850606|NCT04038073|Diagnostic Test|Anti-Deoxyribonuclease B|Test to evaluate of any histories of streptococcal infections
15850607|NCT04038073|Diagnostic Test|TLR, MyD88, IRAK-4 polymorphism|Test to evaluate of the frequency and types of genetic alterations of innate immunity
15850608|NCT04038073|Diagnostic Test|Anti-Basal Ganglia Antibody|Test to evaluate the autoimmune component
15850609|NCT04038060|Behavioral|WhatsApp Group|Participants will receive peer adherence support through WhatsApp groups
15850610|NCT04038060|Behavioral|2-way SMS|Participants will receive healthcare worker adherence support through 2-way SMS
15850611|NCT04038060|Behavioral|Drug level feedback|Participants will receive adherence counseling based on tenofovir drug levels
15850612|NCT04038060|Behavioral|Monthly counseling sessions|Participants will receive monthly counseling on a variety of issues that may be impacting their PrEP adherence
15850613|NCT04038034|Dietary Supplement|CoQ10- MINIACTIVES|COQUN oral formulation 100 mg BID
15850614|NCT04038034|Dietary Supplement|Placebo|Placebo
15850615|NCT04038021|Behavioral|Phosphatidylethanol-based Contingency Management|In CM, tangible reinforcers are provided after individuals demonstrate biochemically verified abstinence of various substances. CM is associated with increased abstinence from illicit drugs, nicotine, and alcohol and is the most powerful psychosocial treatment for initiating abstinence of these substances. When participants submit a negative result for alcohol (via blood phosphatidylethanol biomarkers), the subject will receive rewards (gift cards). In contrast, they will not receive rewards when their samples test positive for alcohol.
15850616|NCT04038021|Behavioral|Non-Contingent Control|In the non-contingent control intervention, participants will receive rewards (gift cards) regardless of the alcohol biomarker results in their samples. Once the samples have been received, the subjects will receive reinforcers that is consistent with the average from the CM group's earnings.
15850617|NCT04038008|Drug|Fluconazole|Fluconazole is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 200 mg of fluconazole.
15850618|NCT04038008|Drug|Diflucan®|Diflucan® is manufactured by Fareva Amboise, France (MAH: PFIZER PHARMA PFE GmbH, Germany). Each hard capsule contains 200 mg of fluconazole.
15850619|NCT04037995|Other|No intervation|No intervation
15850620|NCT04037982|Procedure|laparoscopic pancreaticoduodenectomy|During laparoscopic surgery, the surgeon makes several smaller incisions in your abdomen and inserts special instruments, including a camera that transmits video to a monitor in the operating room. The surgeon watches the monitor to guide the surgical tools in performing the Whipple procedure. Laparoscopic surgery is a type of minimally invasive surgery.
15850621|NCT04037982|Procedure|Open pancreaticoduodenectomy|During an open procedure, your surgeon makes an incision in your abdomen in order to access your pancreas. This is the most common approach and the most studied.
15850622|NCT04037969|Device|Nesofilcon A|Hydrogel contact lens for daily wear
15850623|NCT04037969|Device|Delefilcon A|Silicone hydrogel contact lens for daily wear
15850624|NCT04037956|Procedure|Tubeless NOSES|The whole procedures undergo by total laparoscopic surgery with no specimen extraction incision in the abdominal wall. The specimen then will be removed through natural orifice such (anal).
15850625|NCT04037956|Procedure|traditional laparoscopic radical resection|The traditional laparoscopic operation undergo and then a small incision(5-8cm) is made in the middle of the lower abdominal wall to remove the specimen.
15850626|NCT04037943|Dietary Supplement|Walnuts 30 grams|Roasted walnuts without salt or sugar.
15850627|NCT04037943|Dietary Supplement|Walnuts 60 grams|Roasted walnuts without salt or sugar.
15850628|NCT04037930|Behavioral|multiple implant surgery|Patients older than 30 years who will undergo elective dental implant surgery.
15850629|NCT04037917|Device|CorNeat EverPatch|Covering Ophthalmic Implants
15850630|NCT04037891|Drug|rVA576|"19 Patients with moderate to severe AKC. the study includes two parts: Part 1: The first 3 patients selected for the study will be treated with the active drug in open-label.
~Part 2: Sixteen patients will be randomised 1:1. between active and placebo and patients allocated to either group will receive the appropriate product throughout the trial."
15850631|NCT04037891|Other|Placebo|Part 2: Sixteen patients will be randomised 1:1. between active and placebo and patients allocated to either group will receive the appropriate product throughout the trial.
15850632|NCT04037878|Procedure|Transversus Abdominis Plane Block(TAP Block)|Under ultrasound guidance, a 22 gauge stimuplex needle will be used to approach the transversus abdominis plane and 20ml of 0.25% Bupivicaine will be infiltrated into the TAP space. This procedure will be performed on either sides once anesthesia is induced.
15850633|NCT04037878|Procedure|Intra-peritoneal infiltration|Before skin closure, the surgeon will infiltrate the peritoneal cavity using a mixture of bupivicaine and epinephrine
15850634|NCT04037878|Drug|PCIA Tramadol|All patients will be given patient controlled intravenous analgesia using Tramadol as the drug
15850635|NCT04037865|Drug|PF-06651600|PF-06651600 50 mg oral tablets will be administered on Days 1 to 10
15850636|NCT04037852|Device|robotic assisted nipple sparing mastectomy|R-NSM, which introduce da Vinci surgical platform through a small extra-mammary axillary or lateral chest wound to perform NSM, had been applied in the surgical treatment of early breast cancer or risk reducing mastectomy. R-NSM, which incorporated 3-dimensional (3D) imaging system and flexibility of robotic arm and instruments, was reported to have the potential to overcome the technique difficulty of E-NSM.
15850662|NCT04037657|Drug|Propofol|Propofol, at a dose of 2.5 mg/kg, was administered as a 1 minute infusion at a constant rate via infusion pump.
15850663|NCT04037644|Procedure|Fluid loading with Albumin|Fluid loading with 200 ml of 4% Albumin to reverse acute circulatory failure
15850664|NCT04037644|Procedure|Fluid loading with Ringer Lactate|Fluid loading with 5 ml per kg of actual body weight to reverse acute circulatory failure
15850637|NCT04037852|Procedure|Endoscopic assisted nipple sparing mastectomy|E-NSM, which is performed through small axillary and/or peri-areolar incisions, was reported to be associated with small inconspicuous incision and good cosmetic outcome. Conventional E-NSM was performed with two separate incisions over axilla and peri-areolar regions. E-NSM with areolar incision, just like NSM with areolar related incision (NAC ischemia/necrosis rate: range 7%-81.8%), was associated with increased NAC ischemia/necrosis (reported ranged: 9.1-19%). New technique modifications of E-NSM were emerging focusing on single axillary incision NSM, which spare the peri-areolar incision and thereby decrease the compromise of bloody supply from mastectomy skin flap, was reported to have low NAC necrosis rate (0%).
15850638|NCT04037852|Procedure|Conventional nipple sparing mastectomy|Nipple-sparing mastectomy (NSM), which preserved the nipple areolar complex (NAC) and skin flap during mastectomy, was increasingly performed in breast cancer patients due to better cosmetic outcome, higher patient satisfaction, and maintained oncologic safety.
15850639|NCT04037839|Other|Questionnaire|"Medical records of children aged 0-18 years who were prescribed a HFNC device at Schneider Children's between 2014-2018 for use in the home setting will be reviewed retrospectively. As part of the telephone consent process, parents will be offered to opt out at the beginning of the interview."
15850640|NCT04037826|Dietary Supplement|L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475|L. reuteri Gastrus (L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475) at dose of 2x108 Colony Forming Units (CFU) per tablet. One chewable tablet is to be taken twice per day (one in the morning and one in the afternoon) giving a total daily dose of at least 4x108 CFU/day.
15850641|NCT04037826|Dietary Supplement|Placebo|Placebo
15850642|NCT04037813|Procedure|Laparoscopic and hysteroscopic tubal occlusion for hydrosalpinx|"For hysteroscopic tubal occlusion group it will be done under general anesthesia using standard, rigid 4-mm hysteroscopy with a 30° forward-oblique lens and a 5.5-mm diagnostic sheath (Karl Storz , Germany). Uterine distension allowed a panoramic view of the uterine cavity and identification of the tubal ostia.The roller ball (Ball Electrode, unipolar, 5 Fr) will be used for the coagulation of the interstitial part of the tube and the uterine cornu area.
~For laparoscopic tubal occlusion group it will be done under general anesthesia using bipolar coagulation and a proximal tubal cut."
15850643|NCT04037800|Procedure|SFUR-RARP|Robotic-assisted radical prostatectomy with sustainable functional urethral reconstruction (SFUR)
15850644|NCT04037800|Procedure|Standard RARP|Robotic-assisted radical prostatectomy without sustainable functional urethral reconstruction (SFUR)
15850645|NCT04037787|Procedure|ERAS protocol|In colorectal cancer surgery, the ERAS protocol involves an accurate interview with the patient in the preoperative phase aimed at smoking and alcohol cessation, the reduction of preoperative fasting with administration of oral carbohydrates before surgery, use of intestinal preparation for selected cases only (rectal surgery), the prophylaxis of thromboembolism, a correct antibiotic prophylaxis, the prevention of intraoperative hypothermia, prevention of volume overload, preference for minimally invasive surgery, prevention of postoperative nausea and vomiting, very limited use of the nasogastric tube, early removal of the urinary catheter, multimodal analgesia to minimize opiate consumption, early postoperative mobilization and early post-operative feeding, to promote rapid recovery of gastro-intestinal functions.
15850646|NCT04037774|Drug|Dexmedetomidine|comparision of different doses of dexmedetomidine used intrathecally
15850647|NCT04037774|Other|placebo|addition of placebo with local anesthetic to create a control group
15850648|NCT04037748|Drug|Puran T4®|Participants who received a single oral dose of Puran T4® 600 mcg tablets (3 tablets of 200 mcg Levothyroxine sodium) in either Treatment Period 1 or 2 under fasting conditions.
15850649|NCT04037748|Drug|Eutirox®|Participants who received a single oral dose of Eutirox® 600 mcg tablets (3 tablets of 200 mcg Levothyroxine sodium) in either Treatment Period 1 or 2 under fasting conditions.
15850650|NCT04037735|Device|ATTUNE S+ Knee Prosthesis by DePuy|Total Knee Replacement (TKR) Surgery with ATTUNE S+ Knee Prosthesis by DePuy
15850651|NCT04037735|Device|PFC Sigma Knee Prosthesis by DePuy|Total Knee Replacement Surgery with PFC Sigma Knee Prosthesis by DePuy
15850652|NCT04037722|Dietary Supplement|Whey|45 g whey + 20 g maltodextrin
15850653|NCT04037722|Dietary Supplement|3-OHB + Whey|50 g ketone + 45 g whey + 20 g maltodextrin
15850654|NCT04037709|Procedure|scaling and root planing (SRP) + PDT placebo|Patientes will receive periodontal treatment (scaling and root planing - SRP) with universal curettes and ultrasound depending on their needs. The SRP will be done in one session. The PDT placebo wil be done using an agent with the same vehicle as that of the methylene blue to mimic irrigation with the photosensitizer; the laser will be switched off at the time of application.
15850655|NCT04037709|Procedure|scaling and root planing (SRP) + PDT|patients will receive the same scaling and root planing treatment that placebo group.However the PDT will be done using methylene blue 0.005% .The red laser diode (λ = 660 nm) will be applied with an output power of 100mW . The laser head will be positioned in direct contact with the pseudo periodontal pockets.
15850656|NCT04037696|Behavioral|General Health Promotion Approach|"The trained Research assistants will ask the subjects about the priority of engaging in any desirable health-related lifestyle practice as identified in the completed baseline questionnaires and to state a targeted goal that they perceive as the easiest to achieve. Each subject will then receive an individual face-to-face brief MI (about 5 mins) with generic health advice on selected health-related lifestyle practice. They will then be informed to receive an individual brief MI intervention to assist behavioural changes or achieve goals as desired or chosen by them via WeChat or WhatsApp in smart phones throughout the study period.
~The RA will then deliver brief MI to each subject individually via WeChat or WhatsApp in smart phones throughout the study period.
~Readiness of quitting smoking will be assessed at 3-month follow-up. Upon request by subjects, we shall provide them with more comprehensive information on quitting."
15850657|NCT04037696|Behavioral|Control|The subjects will be given general brief advice and a self-help smoking cessation booklet with Hotline (Tel.: 1833183). However, subjects in the control group will not receive brief MI and follow-up booster intervention.
15850658|NCT04037683|Drug|Misoprostol Oral Tablet|Misoprostol 25mcg orally given 2-hourly
15850659|NCT04037683|Drug|Oxytocin|Oxytocin infusion
15850660|NCT04037670|Procedure|SASI bypass|Sleeve gastrectomy with single loop anastomosis between gastric antrum and ileum, 3 meters away from ileocecal junction
15850661|NCT04037657|Drug|HSK3486|HSK3486 was administered as a single dose over a 1 minute infusion period. There were five cohorts of six subjects per cohort (5 HSK3486:1 propofol).
15850670|NCT04037605|Drug|Dexamethasone injection|Dexamethasone IV injection is given twice per inpatient visit
15850671|NCT04037605|Drug|Cosyntropin Injectable Product|Cosyntropin injection is given twice per inpatient visit
15850672|NCT04037605|Drug|Recombinant Human Luteinizing Hormone (also known as luveris)|Recombinant Human Luteinizing Hormone is given as 6 IV infusion pulses per inpatient visit
15850673|NCT04037605|Drug|Hydrocortisone Injection (also known as solu-cortef)|Hydrocortisone IV push is given twice per inpatient visit
15850674|NCT04037605|Drug|Gonadorelin (also known as Lutrepulse)|Gonadorelin IV injection is given twice per inpatient visit
15850675|NCT04037605|Drug|Corticorelin (also known as Acthrel)|Corticorelin IV injection is given twice per inpatient visit
15850676|NCT04037605|Drug|Placebo oral tablet|Placebo for Ketoconazole are given 4 times per inpatient visit
15850677|NCT04037605|Drug|Saline Solution|Saline Solution (Placebo) for Dexamethasone IV injection or hydrocortisone IV injection given up to four times per inpatient visit
15850678|NCT04037605|Drug|Saline solution for injection|Saline Solution (placebo) for ganirelix subcutaneous injection
15850679|NCT04037592|Device|Active standardized iTBS-DMPFC|Participants in the standardized dosage(600 pulse) of intermittent TBS(iTBS) active stimulation group will receive 3-week three-pulse 50-Hz bursts administered every 200 milliseconds (at 5 Hz) at an intensity of 80% active motor threshold (MT) to bilateral DMPF, twice a day. Bilateral side DMPFC will be targeted by MRI-neuronavigation system. Stimulation will be delivered to the DMPFC using a Magstim stimulator.
15850680|NCT04037592|Device|Active high-dosage iTBS-DMPFC|Participants in the standardized dosage(1800pulse) of intermittent TBS(iTBS) active stimulation group will receive 3-week three-pulse 50-Hz bursts administered every 200 milliseconds (at 5 Hz) at an intensity of 80% active motor threshold (MT) to bilateral DMPF, twice a day. Bilateral side DMPFC will be targeted by MRI-neuronavigation system. Stimulation will be delivered to the DMPFC using a Magstim stimulator.
15850681|NCT04037592|Device|Sham standardized iTBS-DMPFC or high-dosage iTBS-DMPFC|Half of the patients in the sham group received 3-week the same standardized iTBS parameter stimulation (standardized sham-iTBS), and the other half received the same high dosage iTBS parameter stimulation using a sham coil (high dosage sham-rTMS), which also improved the blinding process
15850682|NCT04037579|Other|Survey|Non-randomised survey
15850683|NCT04037566|Genetic|XYF19 CAR-T cell|Autologous T cells engineered to specify CD19 transduced with a lentiviral vector and electroporated with CRISPR guide RNA to disrupt expression of endogenous HPK1 administered by IV injection.
15850684|NCT04037566|Drug|Cyclophosphamide|A cytotoxic chemotherapy agent used for lymphodepletion prior to XYF19 CAR-T cells.
15850685|NCT04037566|Drug|Fludarabine|A chemotherapy agent used for lymphodepletion prior to XYF19 CAR-T cells.
15850686|NCT04037553|Other|Intracuff pressure measurement|Intracuff pressure values were monitorized and noted before and after head and neck positions and during the surgeries at 15th, 30th, 60th and 90th minutes at related positions and just before extubation at neutral position.
15850687|NCT04037553|Other|Intracuff pressure measurement|Intracuff pressure values were monitorized and noted before and after head and neck positions and during the surgeries at 15th, 30th, 60th and 90th minutes at related positions and just before extubation at neutral position.
15850688|NCT04037553|Other|Intracuff pressure measurement|Intracuff pressure values were monitorized and noted before and after head and neck positions and during the surgeries at 15th, 30th, 60th and 90th minutes at related positions and just before extubation at neutral position.
15850689|NCT04037540|Procedure|Operational approach|Operational approach was used to treat the Jones fracture in patients randomized into the respective study arm.
15850690|NCT04037540|Procedure|Conservative approach|Conservative approach was used to treat the Jones fracture in patients randomized into the respective study arm.
15850691|NCT04037527|Drug|Gemcitabine|Gemcitabine will be administered on day 1 of each one-week cycle for 6 cycles concurrently with radiation to the extremity on a 3+3 escalating dose (100 mg/m² to 300 mg/m²)
15850692|NCT04037527|Drug|Docetaxel|Docetaxel will be administered on day 1 of each one-week cycle for 6 cycles concurrently with radiation to the extremity (10 mg/m² to 25 mg/m²).
15850693|NCT04037527|Radiation|Radiation|Radiation is to be done with standard preop dose of 50 Gy but at lower doses per fraction. Thus 50.4 Gy in 28 FX. Radiation will be given for 5 days (Monday - Friday) every week for approx. 6 weeks.
15850694|NCT04037527|Procedure|Surgical Resection|Upon completing neoadjuvant chemotherapy plus radiation therapy, surgical resection will occur.
15850695|NCT04037527|Other|Blood draws|Before treatment, blood (about 2 tubes of 10 mls each) to better understand some aspects of participants' immune system before chemotherapy.
15850696|NCT04037514|Drug|Paracetamol|Intravenous paracetamol 15 mg/kg/6h
15850697|NCT04037514|Drug|Ibuprofen|Intravenous ibuprofen 10 mg/kg/24h (day 1) and 5 mg/kg/24h (day 2 and 3)
15850698|NCT04037501|Other|Care Management|A computerized Care Management System (CMS) will identify unmet needs of the informal caregiver of PwD and generates suggestions for interventions. Based on these, the treating physician develops an individualized treatment and care plan and assigns specific tasks to the care manager. Upon a home visit in the caregivers' home the care manager evaluates the need for additional tasks. Based on the complete list of tasks, the care manager initiates the implementation of respective actions. Via monthly telephone calls and optional home visits the care manager monitors the status of implementation and actively coordinates the support and care for the informal caregiver recommended intervention
15850699|NCT04037488|Diagnostic Test|Inbody 320|Total Skeletal muscle mass (SMM), Skeletal muscle index (SMI), Relative Skeletal muscle mass index (RASM), Fat body mass (FBM), Body mass index (BMI), Body fat percentage, Body water content, Edema Value were calculated by Inbody 320
15850728|NCT04037241|Drug|NLIR+FU/FA|systemic chemotherapy regimen
15850729|NCT04037241|Drug|Capecitabine|systemic chemotherapy regimen
15850753|NCT04037007|Procedure|Fistulotomy - Low experienced.|We will perform a duodenoscopy, once located next to the papilla, we will perform precut fistulotomy on the papillary infundibulum with a needle knife with EBRE, EndoCut I, Effect 2, until biliary fluid exit is seen or the biliary duct is noted, then we will access to the biliary tree to complete de procedure.
15850781|NCT04036773|Dietary Supplement|Fruit and vegetable deliveries|Weekly home deliveries of approximately 15 pounds of fresh fruits & vegetables
15850700|NCT04037475|Device|photodynamic therapy herpes labialis|Patients will receive Photodynamic Therapy (PDT), irradiations will be performed with the Laser Duo® red laser diode (MMOptics, São Carlos, SP, Brazil) with a wavelength of 660 nm, with a power of 100 mW, the energy density of 300 J / cm², with energy of 3 J in the center of the lesion for 30 seconds. The laser will be positioned in direct contact with the lesion, perpendicular, applied centrally to each isolated lesion that presents with fixed energy per point of 3J. Wash in abundance with saline solution until the removal of the photosensitizer is complete. All treatment proposed in group 1 (simulation of PDT + delivery of aciclovir cream) in each patient will be concluded in a single session. Treatment for group 2 (PDT + placebo cream) will also be completed in a single session. All possible adverse effects will be noted and qualified during the treatment protocol and maintenance period (3/3 months) using the questionnaire developed for this protocol.
15850701|NCT04037462|Drug|Dexamthasone|escalating doses of pretreatment dexamethasone in patients who have failed initial immunotherapy to 1. assess changes in FLT PET uptake 2. assess overall response rates of pretreatment dexamethasone (dose from 1) on subsequent immunotherapy re-challenge
15850702|NCT04037449|Procedure|TAP block|With the patient placed in the supine position, after asepsis of the skin with chlorhexidine, bilateral TAP blockage will be carried out under ultrasound control. We will use a high frequency linear transducer (12-15 MHz) on one side of the abdominal wall, at the level of the mid-axillary line, between the costal margin and the iliac crest. At this level we can identify three muscle layers, from superficial to deep: external oblique muscle, internal oblique muscle and transverse muscle of the abdomen. We will move the transducer more laterally to locate the most posterior border of the internal oblique and transverse muscles. It is at this level that we perform the posterior TAP blockade: we administer 10 ml of 2% Mepivacaine plus 10 ml of 0.5% Bupivacaine between the fasciae of the internal oblique muscle and the transverse muscle of the abdomen and observe an appropriate diffusion pattern of local anesthetics
15850703|NCT04037449|Other|Conventional analgesia|"Intravenous dexketoprofen 50 mg / 8 hours, alternate with intravenous paracetamol 1g / 8 hours. If allergy to Nonsteroidal anti-inflammatory drugs (NSAIDs) or in case of renal failure: Intravenous metamizol 2g / 8 hours alternate with intravenous paracetamol 1g / 8 hours.
~Rescue Analgesia: intravenous morphine (2 mg every 15 minutes until VAS less or equal to 3)"
15850704|NCT04037436|Other|Strength and Balance Training & Nutrition Education|Exercise:A kinesiologist-led twice-weekly program. Prior to attending the program, each attendee gets a 1:1 session with the kinesiologist to decide exercise starting levels. Group exercises start with a warm-up stepping game. Participants then perform 2 sets of 8 repetitions of each exercise, gradually progressing to an intensity of 3-8 repetitions maximum. Exercises include one each of a push, pull, squat, reach/press, lunge/step-up, lift and carry movement. After, there is a 10-minute group discussion to prompt making exercise routine at home. Nutrition:Two dietitian-led interactive group seminars to promote strategies to increase protein intake and sampling of protein-rich snacks and protein supplements. Seminar topics consider the cost to prepare high protein foods, the ability of retirement home residents to alter diet, how and why to spread protein intake through the day, how much protein is in their usual choices, and easy-to-consume protein-rich snacks.
15850705|NCT04037436|Other|Usual Care|During periods when a site is not involved in the MoveSTroNg program, participants will continue with their usual care routine. Usual care routines should not involve strength and balance exercises.
15850706|NCT04037397|Drug|Anti Arrhythmics|Propafenone or Flecanide or Sotalol or Dofetilide or Dronedarone or Amiodarone. The subject must first fail a Class 1C or III drug prior to starting Amiodarone
15850707|NCT04037397|Procedure|Pulmonary Vein Isolation performed by Radio Frequency Catheter Ablation|Approved Biosense Webster Inc. catheter devices should be used to perform RFCA. Ablation will be done to achieve entrance block into all pulmonary veins
15850708|NCT04037384|Behavioral|Eye yoga|Eye yoga exercises at home given by a trained instructor
15850709|NCT04037384|Behavioral|Passive Reading|Passive reading at home
15850710|NCT04037371|Other|Cold exposure|Participants were tested for white fat thermogenic activity against their environmental temperature exposure
15850711|NCT04037358|Drug|Radium-223|Radium-223 plus SABR will be within two weeks.
15850712|NCT04037358|Radiation|stereotactic ablative radiotherapy (SABR)|SABR 1-5 fractions
15850713|NCT04037345|Biological|SMUP-IA-01(low-dose)|A single knee administration of SMUP-IA-01(low-dose, 4.0 x 10^6 cells/2mL)
15850714|NCT04037345|Biological|SMUP-IA-01(mid-dose)|A single knee administration of SMUP-IA-01(mid-dose, 1.0 x 10^7 cells/2mL)
15850715|NCT04037345|Biological|SMUP-IA-01(high-dose)|A single knee administration of SMUP-IA-01(high-dose, 2.0 x 10^7 cells/2mL)
15850716|NCT04037332|Other|Blood sample (combined with malaria RDT) followed by gentoyping analysis|Finger-prick blood samples collected from children with signs of severe febrile illness and a positive mRDT presenting to community-based providers and referral facilities ; analysis for mutations in portions of a P. falciparum gene encoding kelch (K13)-propeller domain
15850717|NCT04037319|Diagnostic Test|24 Hour Holter Monitor|24 hour holter monitor to be performed pre-operatively, and at day 30 and 90 post-operatively.
15850718|NCT04037306|Behavioral|Butyrate Feedback|Measure concentrations of stool butyrate by gas chromatography, returned to participants in summary report.
15850719|NCT04037306|Behavioral|Fiber Feedback|Estimated fiber consumption from menu records of weight loss facility.
15850720|NCT04037293|Diagnostic Test|CIMT and baPWV measurement|All patients will receive carotid intima media thickness (CIMT) and brachial-ankle pulse wave velocity (baPWV) measurement at baseline and 5-year follow-up.
15850721|NCT04037280|Other|Exercise|Four type of exercises will be delivered to patients. These exercises differ for posology and typology.
15850722|NCT04037267|Procedure|endoscopic intraventricular evacuation surgery|According to the discussion between the patient and the doctor, the patient signed the consent form and voluntarily enrolled and subsequently the patient was included in the endoscopic intraventricular evacuation surgery group.
15850723|NCT04037254|Biological|Gonadotrophin Releasing Hormone|Receive standard of care GnRH agonist androgen suppression therapy
15850724|NCT04037254|Radiation|Intensity-Modulated Radiation Therapy|Undergo standard of care IMRT
15850725|NCT04037254|Drug|Niraparib|Given PO
15850726|NCT04037241|Biological|Anti-CEA CAR-T cells|Doses will be delivered by hepatic arterial infusions using a pressure enabled drug delivery (PEDD) device
15850727|NCT04037241|Drug|gemcitabine/nab paclitaxel|systemic chemotherapy regimen
15850730|NCT04037228|Device|KneeAlign 2 system (OrthAlign Inc, Aliso Viejo, California)|The KneeAlign 2 system (OrthAlign Inc, Aliso Viejo, California) is an accelerometer-based, portable navigation device for TKA that attempts to combine the alignment accuracy of large-console CAS systems, with the ease of use and convenience of conventional alignment methods. It is used to perform the proximal tibial and distal femoral resections in TKA. It consists of a disposable display console (2 × 4 × 2 inches in size) and a reference sensor, both of which are used for the tibial and femoral resections The display console and reference sensor each contains triaxial accelerometers that communicate wirelessly with one another. Briefly, the tibial jig has 2 primary components (a fixed component and a mobile component) connected by a proximal articulation .The fixed component, with the attached reference sensor, is first pinned to the tibia. The purpose of the fixed component is to account for the movement of the tibia during cutting block alignment.
15850732|NCT04037202|Other|Foot massage|Foot massage includes classical massage techniques such as effleurage, petrissage and friction techniques. Effleurage is the movement of stroking and lubricating superficial tissues. Therefore, it is performed at the beginning and ending of the massage. Petrissage is the slow and rhythmic movement to apply direct pressure to the soft tissue underlying the skin with the balls of the fingers and thumbs. Friction is the application of pressure through small circular movements only in small areas, using hand or fingers. While muscle tissue is compressed and relaxed, blood and lymph circulation increases. Thus, lactic acid in the muscle fibers is diminished and fatigue and stress are decreased.
15850733|NCT04037176|Drug|Omalizumab|Subcutaneous administration every 2. week or every 4. week. Dose is depending of the patients weight and IgE
15850734|NCT04037176|Other|Placebo|Subcutaneous administration every 2. week or every 4. week. Dose is depending of the patients weight and IgE
15850735|NCT04037163|Diagnostic Test|Fractional flow reserve, Coronary CT angiography|Coronary CT angiography was performed as part of routine clinical practice for patients with suspected coronary artery disease and the decision to perform coronary CT angiography before invasive angiography was at the judgment of the physicians in charge.
15850736|NCT04037150|Diagnostic Test|Circulating tumor DNA|Circulating tumor DNA
15850737|NCT04037137|Other|Questionnaire|Caregiver Difficulties Scale, Impact on Family Scale, WHOQOL-BREF Quality of Life Assessment, Nottingham Health Profile, Fatigue Severity Scale, Beck Depression Scale
15850738|NCT04037124|Procedure|Cervical procedure|simple hysterectomy, radical hysterectomy or fertility sparing surgery
15850739|NCT04037111|Device|Transcutaneous electrical vagus nerve stimulation|The patient received active VNS and escitalopram oxalate tablets for 2 months.When the VNS was stimulated, the two electrodes were vertically attached to the left carotid sinus at 2cm, or the auricular clip electrode was applied to the tragus.
15850740|NCT04037111|Device|Sham vagus nerve stimulation|The patient received sham VNS.When the VNS was stimulated, the two electrodes were vertically attached to the left carotid sinus at 2cm, or the auricular clip electrode was applied to the tragus.
15850741|NCT04037111|Drug|drug treatment|Escitalopram oxalate tablets should be taken orally once every morning for 2 months, each time 10-20mg
15850742|NCT04037098|Dietary Supplement|Magnesium lactate.|2 tablets orally every 12 hours (equivalent to 360 mg of elemental magnesium) for 3 months
15850743|NCT04037098|Dietary Supplement|Placebo|2 tablets orally every 12 hours of on inert placebo for three months
15850744|NCT04037085|Drug|Ketamine|Subjects in the intervention arm will receive bolus and infusion dosing as noted in arm/group descriptions at the time of cord clamping. Duration of infusion will be 12 hours. Breastmilk, maternal serum and urine, side effects, adverse events, and efficacy endpoints will be measured over the 12 hour infusion and over 15 hours after infusion discontinuation. For the weaning population, they will receive a 12 hour infusion in the CTRC and stay an additional 12 hours in the CTRC (or until discharged). Breastmilk, maternal serum and urine, side effects, adverse events, and efficacy endpoints will be measured over the 12 hour infusion and for 12 hours after infusion discontinuation.
15850745|NCT04037072|Drug|Mitomycin C|Topical application of Mytomycin C (MMC)
15850746|NCT04037072|Other|Control|Topical application of Normal Saline
15850747|NCT04037046|Behavioral|Screening HCV attached onto CCR screening|Patients assigned to this strategy will receive an invitation letter for HCV screening with DBS and CCR screening with FOT at the primary care center to be performed by the general practitioner
15850748|NCT04037046|Behavioral|Screening HCV attached onto CCR screening by self-testing|Patients assigned to this strategy will receive an invitation letter for self-testing for HCV screening with DBS, and CCR screening with FOT
15850749|NCT04037046|Behavioral|Screening HCV at primary care center|DBS for HCV screening at primary care center
15850750|NCT04037033|Behavioral|Everyday Meaningful Activities (EMA) intervention|"The EMA intervention will include 6 intervention sessions. At session 1, the interventionist and participant will identify 2 meaningful active lifestyle behavior goals using COPM. Last, an action plan will be created for behavior 1. Participants will be asked to implement the action plan everyday.
~At session 2, the interventionist and participants will review the daily activity log and the action plan.
~At session 3, the interventionist and the participants will review the daily activity log and the action plan.
~At session 4, an action plan will be created for behavior 2. Participants will be asked to implement the action plan for behavior 2 everyday.
~At session 5, the participants and interventionists will discuss the participant's daily activity log and action plan.
~At session 6, the participants and interventionists will discuss the participant's daily activity log and action plan."
15850751|NCT04037020|Other|Chocolate|Participants will be asked to taste commercially available chocolate varying in sugar, fat and percent cocoa (extreme dark (90%), dark (70%), milk (38%), and white (0%)).
15850752|NCT04037007|Procedure|Fistulotomy - High experienced.|We will perform a duodenoscopy, once located next to the papilla, we will perform precut fistulotomy on the papillary infundibulum with a needle knife with EBRE, EndoCut I, Effect 2, until biliary fluid exit is seen or the biliary duct is noted, then we will access to the biliary tree to complete de procedure.
15850754|NCT04037007|Procedure|Conventional (guidewire) cannulation- High experienced|We will perform a duodenoscopy, once located next to the papilla, we will perform cannulation with sphincterotome and hydrophilic tipped guidewire aided by fluoroscopy, once the guidewire reaches de common bile duct (seen on fluoroscopy) we will continue with the procedure according to the patient's indication.
15850755|NCT04037007|Procedure|Conventional (guidewire) cannulation - Low experienced|We will perform a duodenoscopy, once located next to the papilla, we will perform cannulation with sphincterotome and hydrophilic tipped guidewire aided by fluoroscopy, once the guidewire reaches de common bile duct (seen on fluoroscopy) we will continue with the procedure according to the patient's indication.
15850756|NCT04036994|Device|Photobiomodulation therapy|All patients will undergo photobiomodulation therapy sessions twice-weekly for the total duration of 12 weeks starting at their last CT administration.
15850757|NCT04036994|Device|Sham photobiomodulation therapy|All patients will undergo placebo photobiomodulation therapy sessions twice-weekly for the total duration of 12 weeks starting at their last CT administration.
15850758|NCT04036981|Drug|Botulinum toxin type A|Injection of botulinum toxin A into the spastic elbow flexor muscle or muscles
15850759|NCT04036968|Drug|Within-subject test of blinded study medications|This is a double-blind within-subject Phase II trial. As such, study medications must remain blinded. Participants may receive a dose of medication from one or more of the following categories: prescription stimulants, prescription benzodiazepines, prescription opioids, prescription cannabinoids, over-the-counter medications, or placebo (sugar pill). This study will use a within-subject design, and all participants will serve as participants' own control. Study medication administration will be randomized within each participant.
15850760|NCT04036955|Other|INFOSA-DEM|Caregivers in the intervention group received the INFOSA-DEM programme, together with usual care provided by the participating centres, while caregivers in the CG received usual care in the centres where the follow-up was carried out.
15850761|NCT04036942|Procedure|Ablation of the gastroesophageal junction with hybrid argon plasma|In the management group with argon plasma hybrid after marking 270 degrees of the esophagogastric junction, submucosal elevation and argon plasma burn of the marked and elevated area is performed.
15850762|NCT04036942|Procedure|mucosectomy with band of the gastroesophageal junction|In the management group with mucosectomy after marking 270 degrees of the esophagogastric junction, a submucosal elevation of the marked area is performed to subsequently perform ligation and resection with a hot snare below the ligation area.
15850765|NCT04036916|Other|Virtual Reality Sensorimotor Training|Games/activities specifically developed to train the sensorimotor system in headset virtual reality + strengthening of the neck
15850766|NCT04036903|Radiation|computed tomography|thoracic CT examinations for diagnosis, and/or follow-up.
15850767|NCT04036890|Drug|2% minocycline hydrochloride controlled-delivery system (MHS)|The test product is a highly viscous gel for local subgingival placement composing of an ointment containing micro-capsule type particles for sustained release and the active ingredient 2% minocycline gel (10mg in each syringe of 0.5g) (Periocline, SUNSTAR, Osaka, Japan). The other ingredients include magnesium chloride, hydroxyl-ethylcellulose, aminoalkylmethacrylaye copolymer, triacetin and concentrated glycerine, giving the preparation a sustained-released property. It will be applied to experimental teeth and the adjacent teeth by gently inserting the tip of a specially designed applicator until the paste flows over the gingival margin.
15850768|NCT04036890|Drug|Placebos|It is the same gel as MHS but without active ingredient minocycline hydrochloride.
15850769|NCT04036877|Other|Mood Disorder Assessment|Assess depression, anxiety, HRQOL, and financial toxicity in both bladder cancer patients and their caregivers via telephone survey
15850770|NCT04036851|Behavioral|Peer support intervention|Peer support groups will meet monthly for the duration of follow-up, with separate groups for pregnant and postpartum women. Groups will be facilitated by women who are living with HIV and have experience of PMTCT services in this setting. Group sessions will include brief information and a structured discussion about a relevant topic, followed by opportunities for unstructured discussion.
15850771|NCT04036838|Combination Product|PyloPlus UBT System|Breath will be analyzed for change in carbon 13 content in breath after ingestion of enriched carbon 13 urea.
15850772|NCT04036838|Diagnostic Test|Histology|Biopsy specimen fixed with 10% buffered formalin were cut into 4mm sections, stained with Giemsa stain, and examined by experienced pathologist
15850773|NCT04036838|Diagnostic Test|Rapid Urease Test|Biopsy specimen obtained and placed onto Rapid Urease Test
15850774|NCT04036838|Diagnostic Test|H.pylori Culture|Biopsy specimen obtained and sent to lab for culture analysis
15850775|NCT04036825|Dietary Supplement|Liquid Nutritional Supplement from Hospital Product|Liquid Nutritional Supplement from Hospital Product is given 2 times daily for 14 days
15850776|NCT04036825|Dietary Supplement|Placebo|Standard nutritional supplement is given 2 times daily as placebo for 14 days
15850777|NCT04036812|Procedure|Superficial cervical plexus block|superficial cervical plexus nerve block will be performed under the guidance of ultrasound
15850778|NCT04036812|Other|Control group|ultrasound guidance will be used to determine the location of superficial cervical plexus nerve. The puncture will also be performed by ultrasound guidance, covered with opaque infusion dressing but performed with infusion of 10 ml normal saline.
15850779|NCT04036786|Behavioral|study group|We prepared a preeclampsia education booklet in accordance with the literature,The content of the booklet was guided by the opinion of experts. It was written in easily understandable language and contained attractive and colorful illustrations. This booklet contents were definition and risk factors for the development of preeclampsia, maternal and fetal damages, recommendations for preventing its development (diet, rest, study, exercise, coping with stress techniques), follow-up of symptoms at home (blood pressure, weight and edema follow-up, counting fetal movements), danger signs, drug use, follow up in hospital, risk of developing in subsequent pregnancies, and its results. Pregnant women in the study group were given education and counseling at four times in addition to standard care, using the preeclampsia education booklet, in a special place. The participants' questions were answered, and each received a copy of the booklet.
15850780|NCT04036786|Behavioral|standard care|standard pregnancy follow up
15850897|NCT04035837|Drug|pegylated interferon-alfa|All the patients in this study will receive pegylated interferon for all course.
15850782|NCT04036760|Behavioral|Research transitional care coordination|Though care coordination was offered to all HCV positive inmates who are approached,the care coordination will still constitute a research intervention that requires informed consent, rather than a new uniform standard of care, to allow maximum autonomy for this incarcerated population.
15850783|NCT04036734|Diagnostic Test|Longitudinal|Longitudinal orientation of ultrasound to long axis of vein to guide access needle
15850784|NCT04036734|Diagnostic Test|Transverse|Transverse orientation of ultrasound to long axis of vein to guide access needle
15850785|NCT04036721|Drug|Prolonged glucocorticosteroid (prednisone) regimen|Prolongation of maintenance therapy with prednisone of patients with pneumonitis inducted by anyi-PD-1/anti-PD-L1 antibodies.
15850786|NCT04036721|Drug|Short glucocorticosteroid (prednisone) regimen|Prednison regimen based upon American Society of Clinical Oncology and European Society for Medical Oncology Clinical Practice Guidelines on pneumonitis treatment in patients receiving immunotherapy agents
15850787|NCT04036708|Behavioral|Wetting method (WTM)|The wetting method is an evidence-based, simple process to remove cyanogens from cassava flour. It involves teaching women to add water to cassava flour and allow it to stand for 2 h in the sun or 5 h in the shade for the hydrogen cyanide gas to escape. Colorfully illustrated and durable laminated posters depicting the WTM will be distributed to participating households. Women will receive this training bi-weekly for 12 months
15850788|NCT04036708|Behavioral|Mediational Intervention for Sensitizing Caregivers (MISC)|The study team will use MISC to train DRC mothers in practical day-to-day activities with their children to enhance 5 key mediational processes: 1) focusing (getting the child's attention and engaging directing them to learning experiences); 2) exciting (communicating excitement, appreciation, and affection with the learning experience); 3) expanding (making the child aware of how the learning experience transcends the present situation and can include past and future issues beyond the immediate need of the moment); 4) encouraging (emotional support to foster the child's sense of security and competence); and 5) regulating (helping to direct the child's behavior in constructive ways with a goal towards self-regulation).
15850789|NCT04036695|Device|Reveal LINQ insertable cardiac monitoring system|A small implantable cardiac monitor (Reveal LINQ device) will be inserted under local anaesthetic in an outpatient procedure. The Reveal LINQ device is composed of two electrodes and is used to continuously monitor electric activity temporally. It can detect arrhythmic episode and record up to 27 minutes of electrocardiographic (ECG) activity. This device is capable of continuous monitoring of patient's ECG activity for up to three years and will be utilized in this study to obtain initial information on the timing and nature of the arrhythmia suffered by hemodialysis patients leading to SCD.
15850790|NCT04036682|Drug|CLN-081|CLN-081 tablets
15850791|NCT04036656|Drug|SYHA136 0.5 mg|oral tablet
15850792|NCT04036656|Drug|SYHA136 1 mg|oral tablet
15850793|NCT04036656|Drug|SYHA136 2.5 mg|oral tablet
15850794|NCT04036656|Drug|SYHA136 5 mg|oral tablet
15850795|NCT04036656|Drug|SYHA136 10 mg|oral tablet
15850796|NCT04036656|Drug|SYHA136 20 mg|oral tablet
15850797|NCT04036656|Drug|SYHA136 35 mg|oral tablet
15850798|NCT04036656|Drug|SYHA136 50 mg|oral tablet
15850799|NCT04036656|Drug|Placebo matching SYHA136 0.5 mg|oral tablet
15850800|NCT04036656|Drug|Placebo matching SYHA136 1 mg|oral tablet
15850801|NCT04036656|Drug|Placebo matching SYHA136 2.5 mg|oral tablet
15850802|NCT04036656|Drug|Placebo matching SYHA136 5 mg|oral tablet
15850803|NCT04036656|Drug|Placebo matching SYHA136 10 mg|oral tablet
15850804|NCT04036656|Drug|Placebo matching SYHA136 20 mg|oral tablet
15850805|NCT04036656|Drug|Placebo matching SYHA136 35 mg|oral tablet
15850806|NCT04036656|Drug|Placebo matching SYHA136 50 mg|oral tablet
15850807|NCT04036643|Radiation|PET-MRI|Hybrid PET / MRI machine for simultaneous acquisition of functional and molecular information of different natures coupled with the high anatomical resolution of MRI.
15850808|NCT04036630|Device|Transcranial alternating current stimulation (tACS)|"The main study intervention is tACS stimulation. TACS is a non-invasive brain stimulation (NIBS) techniques that belong to the class of low current transcranial electric stimulation. In contrast to the better known transcranial direct current stimulation (tDCS), the tACS current is not constant, but alternates with a certain frequency.
~The aim of the tACS stimulation is to enhance degraded speech comprehension in healthy individuals.
~TACS stimulation will be applied over the left ventral motor cortex, with a current intensity of 2mA (peak-to-peak)
~The arm will be compared to the tACS sham stimulation condition."
15850809|NCT04036630|Device|Transcranial magnetic stimulation (TMS) induced motor-evoked potentials (MEPs)|"TMS is a technique where a transient magnetic field (or pulse) is used to cause an electric current to flow in a targeted brain area via electromagnetic induction. The pulse causes the rapid and above-threshold depolarisation of cell membranes affected by the current. Therefore, TMS induces a current that elicits action potentials in neurons.
~MEPs are electrical potentials recorded from a target muscle after TMS stimulation. In experiment 1, so-called articulatory MEPs will be recorded from participants' lip muscle (orbicularis oris). Articulatory MEPs will be recorded by placing two recording electrodes on the right part of orbicularis oris and a reference electrode on the right temple."
15850810|NCT04036617|Drug|NaQuinate|SAD cohorts will receive 1 dose between 10-150 mg. MAD cohorts will receive 7 days dosing between 70-150mg
15850811|NCT04036617|Drug|Placebo|SAD cohorts will receive 1 dose of placebo between 10-150 mg. MAD cohorts will receive 7 days dosing of placebo between 70-150mg
15850812|NCT04036604|Other|Exercise|"Pelvic floor exercise programme include repetition of pelvic floor muscle contraction during twice a week for 8 weeks performed by an expert pelvic health physiotherapist.
~Pelvic floor education programme include pelvic floor anatomy, information about pelvic floor dysfunction and behavioral changes."
15850813|NCT04036591|Diagnostic Test|Acute Bronchiolitis Severity Scale (ABSS)|All infants will be assessed using the Acute Bronchiolitis Severity Scale (ABSS) before and after being treated by experienced physiotherapists using the prolonged slow expiration technique and provoqued cough. Before the application of these techniques a retrograde rhinopharyngeal unclogging will be performed in order to clean the nasopharynx.
15850814|NCT04036578|Device|A 12-week PFMT bio-assisted surface electromyographic program|
15850815|NCT04036565|Behavioral|sunlight therapy|Exposed to sunlight for at least 30 minutes per day, at least 14 days of exposure duration of 4 weeks.
15850816|NCT04036539|Procedure|Placement of the mini-implant and verticalization|an orthodontic mini-implant will be installed in the retromandibular region. The site will be anesthetized. The region will be pre-drilled by about 5mm with a spear drill attached to an implant motor. Once the mini-implant has been selected, it will be locked into position using a kit-specific digital key. Being threaded clockwise until the intramucosal mini-implant is at the gingival level. After installation, a metallic orthodontic lingual will be glued to the molar mesial to be verticalized. The lingual button will be glued to the inclined molar mesial with orthodontic adhesive. A gray chain elastomeric ligature will attach the head of the mini-implant to the lingual button glued to the molar mesial. A light force of 150gr will be imposed (measured with a tensiometer) in all cases, regardless of tooth position. This chain elastic will be changed every 30 days for a period of 3 months. After 90 days of the experiment time, the mini-implants will be removed.
15850817|NCT04036526|Biological|Vaccine GamLPV|live intranasal vaccine for whooping cough prevention
15850818|NCT04036526|Other|Placebo|Placebo
15850819|NCT04036513|Procedure|MINST|"For reducing the need of surgical treatment in patients with chronic periodontal disease, we will use specifically designed Hu-Friedy curettes mini five, micro mini five and after five together with piezoelectric device with thin and delicate tips that produce less periodontal trauma than usual Gracey curettes."
15850820|NCT04036513|Procedure|Conventional SRP|Scaling and root planing with conventional instruments.
15850821|NCT04036500|Drug|Estradiol Tablets|Patients will be given estradiol: 1 mg oral or 1 mg sublingual.
15850822|NCT04036487|Drug|Desflurane|Anesthesia is maintained by desflurane in an oxygen air mixture of 60/40%. If inadequate depth of anesthesia is observed, the end-expiratory concentration of desflurane would be increased.
15850823|NCT04036487|Drug|Propofol|Anesthesia is maintained by propofol 100-200 μg/kg/min. If inadequate depth of anesthesia is observed, the rate of propofol infusion would be increased.
15850824|NCT04036474|Other|Smoking Prevention Education Program|"The SPEP consisted of three lessons and each lesson took one to two hours to be implemented. SPEP was conducted through direct and indirect method. Direct method was conducted through lectures, question and answer, role play and educational videos. The tools used were video projectors and Power Point presentations. On the other hand, the indirect method was done through distributing of badge buttons and fridge magnets Be Free from Smoking. This method brought a simple message to increase awareness among adolescents to prevent smoking uptake. All instruments and protocols in this intervention were pilot tested to confirm feasibility and cultural appropriateness."
15850825|NCT04036461|Drug|CC-99712|CC-99712
15850826|NCT04036461|Drug|BMS-986405|BMS-986405
15850827|NCT04036448|Drug|REVLIMID®|REVLIMID®
15850828|NCT04036435|Drug|BMS-986165|Specified dose on specified days
15850829|NCT04036422|Device|Rejoyce (Rehabilitation Joystick for Computerized Exercise)|Rejoyce (Rehabilitation Joystick for Computerized Exercise), is a computer game based task specific exercise system developed by Rehabtronics Inc. for use as part of the treatment of stroke and spinal cord injury patients. Rejoyce aims to improve upper extremity and hand function by encouraging neuroplasticity through repeated task specific games.
15850830|NCT04036422|Other|Conventional physical therapy|A physical therapy session customised to the patient's needs overseen by a physical medicine and rehabilitation specialist and conducted by a physiotherapist which includes range of motion, neurophysiological and strengthening exercises, balance and coordination training and walking exercises.
15850831|NCT04036422|Other|Occupational therapy|Task based exercises overseen by a physical medicine and rehabilitation specialist and conducted by an occupational therapist aimed at improving upper arm dexterity, coordination and strength.
15850832|NCT04036409|Drug|Intensive Control of Systolic Blood Pressure (SBP)|Participants in the Intensive arm have a goal of SBP <120 mm Hg. Use of angiotensin converting enzyme (ACE)-inhibitors/Angiotension receptor blockers (ARBs), Thiazide-type diuretics, calcium channel blockers (CCB), Sustained-release calcium channel blockers (CCBs) will be encouraged.
15850833|NCT04036409|Drug|Standard control of Systolic Blood Pressure (SBP)|he same medications used in the Intensive BP arm will be used for the Standard BP arm.
15850834|NCT04036396|Behavioral|Mobile Enhanced Prevention Support|Access to the newly developed GeoPassport App, incentives for accessing identified services, and a trained Peer Mentor.
15850835|NCT04036396|Behavioral|Usual Care plus Customized Referrals|Participants in the control arm will continue to receive services they would normally receive consistent with the setting in which they were recruited. This includes substance use treatment in jail, substance use treatment at a residential recovery facility, and/or supportive housing services. The study will provide referrals customized to their needs and preferences.
15850836|NCT04036383|Other|vestibular exercise training|The home exercise program consists of vestibulookular reflex stimulating exercises, lower extremity somatosensory system training, static and dynamic balance exercises
15850837|NCT04036383|Other|Balance training with computerized balance system|Thanks to the receivers under the Neurocom balance master platform, the data of the center of gravity is transferred to the system and visual feedback is provided. Qualitative information reflects progression during static and dynamic postural exercises of the patient. To correct the load distribution, it is necessary to move the cursor to the specified targets in the exercises. The degree of difficulty of training can be increased by increasing the distance between the targets, reducing the time required to reach the targets, changing foot positions or adding upper extremity activity.
15850838|NCT04036383|Other|square step exercises|Elderly individuals in the square step exercise group will perform step exercises on 2.5x1.0 m thin cushions divided into 40 equal parts. Square step exercises include exercises that include anterior, posterior, lateral and diagonal directions of increasing difficulty. The order of the training program is at four different levels and is organized according to small, basic, regular and advanced levels.
15850839|NCT04036370|Procedure|PECS group|Pecs block performed using ultrasound guidance. Standard pain follow up and monitorization will be performed.
15850840|NCT04036370|Other|Control group|Standard pain follow up and monitorization will be performed.
15850841|NCT04036344|Behavioral|Peer Mentorship Program|Mentee participants are paired with a previous MMS patient (Mentor) who is greater than 1 year status post MMS treatment for a facial skin cancer. Mentors and mentees maintain regular contact by telephone, video chat, or in-person meetings throughout the mentee's facial skin cancer treatment with MMS.
15850842|NCT04036331|Behavioral|Brenner FIT Standard|After referral, families attend an orientation, in which they are then scheduled for an initial introductory 2-hour intake group session and cooking class; these occur within 2-4 weeks of the orientation. Monthly 1-hour long visits with the dietitian, counselor, and physical activity specialist are held for 6 months, in which the child and caregiver see the pediatrician. During the 6 months of treatment, they attend 4 group classes, choosing from topics such as meal planning, physical activity, and parenting. Specialized visits with the physical activity specialist or dietician are scheduled as pertinent issues arise. Clinic visits include individualized goal setting (for behaviors family/clinician have agreed to address), healthy eating and physical activity education, and behavioral counseling to implement changes at home.
15850843|NCT04036331|Behavioral|By Design Essentials|A dietitian provides each participant with a detailed program manual that describes the prescribed diet. The dietitian utilizes standard behavioral techniques to promote lifestyle behavior changes that enable participants to implement and maintain behaviors necessary to adhere to the dietary prescription. Participants also receive a standard exercise program designed to promote exercise energy expenditure of approximately 600 kilocalories*/week. The exercise prescription includes resistance training for 2 days per week and aerobic training for 3 days per week, to meet a 600 kilocalories*/week expenditure goal. Behaviorists meet with participants to provide individual and group-based counseling to learn the skills necessary to adopt the prescribed dietary pattern and exercise plans. Group sessions will be delivered consecutively over 6 months (20 total; 1.5 hours each).
15850844|NCT04036331|Behavioral|Dyad Plus|"This will include all components of the standard Brenner FIT program and By Design Essentials.
~In addition, group sessions, one-on-one parent/child communication sessions, joint goal setting/tracking, and home environment assessment. Dyads will attend 6 meetings that will last approximately 1 hour each."
15850845|NCT04036305|Drug|0.9% Sodium Chloride Injection|All participants will be injected subcutaneously with a single 0.5ml dose
15850846|NCT04036305|Drug|Lidocaine Injection 2%|All participants will be injected subcutaneously with a single 0.5ml dose
15850847|NCT04036305|Drug|Bupivacaine Injection 0.5%|All participants will be injected subcutaneously with a single 0.5ml dose
15850848|NCT04036292|Drug|OC-01 (varenicline) nasal spray|OC-01 (varenicline) nasal spray
15850849|NCT04036292|Drug|Placebo (vehicle) nasal spray|Placebo (vehicle) nasal spray
15850850|NCT04036279|Procedure|Total Hip Arthroplasty|
15850851|NCT04036266|Procedure|medial open wedge high tibial osteotomy|opening of medial aspects of the proximal tibial metaphysis and change the coronal alignment of the tibia in order to shift the center of force passing axially through the knee from the arthritic region of the knee towards the unaffected side then fixation with a plate (the standard plate is the T-locked plate )
15850852|NCT04036253|Biological|Erythropoietin alfa|Prefilled syringes of erythropoietin
15850853|NCT04036240|Other|Finger feeding|After discharge, subjects will be given HMF supplementation by finger feeding method using finger feeder
15850854|NCT04036227|Drug|GS-248|GS-248 oral solution
15850855|NCT04036227|Drug|Placebo|Placebo oral solution with the same composition to match active drug
15850856|NCT04036214|Device|Selective Laser Trabeculoplasty|Selective Laser Trabeculoplasty Laser
15850857|NCT04036201|Drug|Bupivacaine|peribulbar block
15850858|NCT04036188|Drug|Triamcinolone|Triamcinolone 0.1% daily
15850859|NCT04036188|Dietary Supplement|Vitamin D3|40,000 IU Vitamin D3 daily
15850860|NCT04036188|Drug|Placebo|Placebo daily
15850861|NCT04036175|Device|High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen|Device High Flow Nasal Oxygen: gas flow of 50L:Min and FiO2 adjusted to obtain SpO2>= 92% Device NIV: Pressure-support level to achieve an expired tidal volume between 6 and 8 ml/kg and PEEP level of 5 cmH2O and FiO2 adjusted for SpO2>= 92%
15850862|NCT04036162|Behavioral|Cognitive tasks|MagnetoEncephaloGraphy (MEG) records
15850863|NCT04036149|Device|Intraocular lens|Implantation as part of cataract surgery
15850864|NCT04036136|Behavioral|Behavioral Activation|Treatment will consist of 15 weekly 45-minute sessions.
15850865|NCT04036136|Behavioral|Mindfulness Treatment|Treatment will consist of 15 weekly 45-minute sessions.
15850866|NCT04036123|Other|Urodynamic investigation|Simultaneous UDI (same session repeat filling cystometry and pressure flow study) with an air-charged and water-perfused measurement system.
15850867|NCT04036110|Dietary Supplement|Vitamin C 500 mg|500 mg tablet taken orally with one meal daily
15850868|NCT04036110|Dietary Supplement|Vitamin C 1000 mg|1000 mg tablet taken orally with one meal daily
15850869|NCT04036110|Other|Placebo|1 tablet taken orally with one meal daily
15850870|NCT04036097|Other|MS-adapted AWIS questionnaire (MS-AWIS)|The predefined questionnaire-based infection score of the Airway Infection Susceptibility (AWIS) study is predictive for the occurrence of respiratory tract infections (RTI). In addition several MS-specific items (e.g. bladder dysfunction and urinary tract infections) are included into the AWIS questionnaire (MS-AWIS).
15850871|NCT04036097|Other|infection diary (MS-AWIS diary)|MS patients prospectively fill out monthly infection diaries for 24 months. Infection diaries will either be sent back (with pre-franked envelopes) or handed back to the InRIMS-study team during regular clinical visits (usually every 6 or 12 months).
15850872|NCT04036084|Diagnostic Test|Cerebral Magnetic resonance imaging (MRI)|Cerebral Magnetic resonance imaging (MRI) 3 Tesla at Inclusion Cerebral Magnetic resonance imaging (MRI) 3 Tesla at Month 1 Cerebral Magnetic resonance imaging (MRI) 3 Tesla at Year 1
15850873|NCT04036071|Device|Total Hip Arthroplasty|Total Hip Arthroplasty using the SL-PLUS™ MIA cement free hip stem
15850874|NCT04036058|Other|Universal gloving|The intervention will consist of all healthcare workers (nurses, providers, respiratory therapists, radiology and laboratory technicians, etc) utilizing universal gloving (non-sterile gloves) for all patient contacts in the units that are randomized to receive the intervention. If a patient in the intervention unit is known to have CDI or a multidrug-resistant organisms, both gowns and gloves will be used as is currently recommended. Signage denoting what type of precautions are needed will be utilized.
15850875|NCT04036045|Other|Cardiac MRI|Patients will have a cardiac MRI at four time points during the study
15850876|NCT04036045|Other|Echocardiogram|Patients will have an echocardiogram at four time points during the study
15850877|NCT04036045|Other|Blood Draw|Patients will have blood drawn at four time points to analyze micro RNAs and Biomarkers before, during and after anthracycline treatment. Patients will also have one blood draw for future genetic sequencing.
15850878|NCT04036032|Other|Exercise program|Encourage to work out 4 to 5 times a week for 3 months. Patient chooses what exercise they would like to do. At YMCA visit for fitness assessments they provide exercise support
15850879|NCT04036019|Biological|CD20-directed CAR-T cells|Autologous 2nd generation CD20-directed CAR-T cells, single infusion intravenously
15850880|NCT04036006|Behavioral|Group-Based Program|The Group-based Program uses an ecologically valid setting in which participants exercise, prepare foods, and eat together to facilitate the emergence of old habits and replace them with healthy alternatives. The intervention team consists of a health psychologist, registered dietitian, and health coach. They co-facilitate group meetings for 15 participants that are held weekly for 3 months, bi-weekly for 3 months, and then monthly in participant-led maintenance meetings. Each session includes: weigh-in and physical activity (20 min), cooking demonstration (20 min), and a shared vegetable dish with discussion (50 min). The maintenance phase (months 7 to 24 post randomization) consists of support and health-related topics of the participants' own choosing. Progress reports with lab results are sent to participants and primary care physicians.
15850881|NCT04036006|Behavioral|Self-Directed Program|The Self-Directed lifestyle program represents enhanced usual care based upon what is currently offered in primary care in the United States for lifestyle treatments for adults with metabolic syndrome. Usual care is enhanced by: 1) lifestyle education for management of metabolic syndrome provided in evidence-based tip sheets from nationally recognized organizations; 2) provision of a Fitbit for self-monitoring physical activity; 3) access to a website containing all education materials; and 4) progress report letters with lab results sent to participants and primary care physicians after completion of each assessment.
15850882|NCT04035993|Other|Controlled hypoglycaemic state while driving with a driving simulator|"Patients will arrive in the morning after an overnight fast. During the controlled hypoglycaemic state, participants will drive on a designated circuit using a driving simulator. Initially, euglycaemic state (5.0-8.0 mmol/L) will be kept stable and then blood glucose will be declined progressively targeting at a level between 2.0-2.5mmol/L by administering an insulin bolus. Glucose will be kept stable at the hypoglycaemic level for 30 minutes. Thereafter, it will be raised again and kept stable for another 30 minutes at an euglycaemic level between 5.0-8.0mmol/L. During the procedure, we will analyse counterregulatory hormones. Heart rate, skin conductance, CGM values, eye movement and facial expression, will be recorded by a smart-watch, a CGM device, an eye-tracker and an onboard camera, respectively.
~Participants will be blinded to the glucose values during the procedure. They will have to rate their symptoms and their performance on a 0-6 scale every 15 minutes."
15850883|NCT04035980|Behavioral|Telemedicine based healthcare programme|Two-way videoconference to evaluate the need of screening with DBS, disease stage evaluation and treatment of HCV RNA positive patients at drug addiction centers
15850884|NCT04035967|Other|Questionnaire|Impact on Family Scale (IPFAM), WeeFIM Pediatric Functional Independence Measurement, Nottingham Health Profile. State-Trait Anxiety Inven¬tory (STAI-I and STAI-II), PEDI (Pediatric Evaulation of Disability Inventory)
15850885|NCT04035954|Other|exercise|The control group will continue the routine NDT: Neurodevelopmental Therapy-based physiotherapy program twice a week. The treatment group will participate in clinical pilates exercises for 2 hours / day for 1 hour / 8 weeks. They will also continue their weekly routine physiotherapy programs.
15850886|NCT04035941|Behavioral|Cycle Nation Multicomponent Intervention|"This intervention group will receive 4 elements:
~Practical skills programme: a workplace-based programme covering basic cycling skills, delivered by trained 'cycle champions' - HSBC staff members.
~Cycle provision scheme: participants will have the opportunity to have their own bicycles serviced or obtain a loaned bike or e-bike from local bike shops before the start of the programme.
~Cycle-friendly workplace culture: all offices taking part will have a minimum of secure bike parking facilities as part of an ongoing roll-out of cycle infrastructure across HSBC UK offices.
~Our Cycle Hub app: an adapted version of an existing HSBC app including route planning, goal setting and practical skills videos, as well as supportive social interaction among participants."
15850887|NCT04035928|Device|3D digital scanning for maxillofacial prosthetics|The non-invasive Artec Space Spider 3D scanner will be used to image the indicated areas of the patients head and face. In the case of an intraoral defect, the noninvasive TRIOS intraoral 3D scanner will be used. The study may also use nasometry or nasal endoscopy to measure the amount of airflow through the patient's fistula to help guide the design. The software that will be used will create a 3D image of the prosthesis during the patient's clinic appointment. Once a model of the prosthesis is fully designed and manufactured, the patient will return to clinic for a second appointment which may involve fitting and coloring. A subsequent appointment will involve delivery of a successfully fitted and colored prosthesis that the patient will take home.
15850888|NCT04035915|Procedure|Limited driving pressure|Keep driving pressure <15 cmH2O
15850889|NCT04035915|Procedure|Conventional mechanical ventilation strategies|Keep tidalvolume </= 8
15850890|NCT04035902|Drug|Ferric carboxymaltose|Ferric carboxymaltose is administered during surgery
15850891|NCT04035902|Drug|control|Ferric carboxymaltose is not administered
15850892|NCT04035889|Dietary Supplement|Melatonin|Participants will start with 0.5 mg tablets of melatonin with the option of switching to an 'escalation dose' of 3 mg if no relief after 3 days.
15850893|NCT04035889|Dietary Supplement|Placebo|Placebo
15850894|NCT04035876|Drug|Camrelizumab plus apatinib|Camrelizumab 200mg q2w iv and apatinib 250mg qd po.
15850895|NCT04035863|Device|Low level laser therapy|"For the PBM protocol, articles of interest were identified through analyses of titles and abstracts. Articles addressing PBM in experimental models or clinical trials of spinal cord injuries were included and articles not pertinent to the proposed study were excluded. Next, the selected articles were analyzed and used for the creation of an initial protocol (Table 1).
~For irradiation, the individuals will be positioned comfortably in lateral decubitus on the examining table. Three points will be irradiated above the lesion level, which will be located using an imaging exam brought by the guardian on the day of the evaluation. After determining the lesion level, palpation of the transverse processes of the vertebrae will be performed. The same laser device (Laser DMC Therapy EC) will be used for both groups. For the placebo group, the device will emit sound but not light."
15850896|NCT04035850|Drug|Vortioxetine Tablets|Strength 5-20 mg
15850898|NCT04035824|Drug|Gastrodia and Uncaria granule|Patients allocated to the intervention group take 10g of Gastrodia and Uncaria granule each time, twice per day, and for two months.
15850899|NCT04035824|Drug|Placebo of Gastrodia and Uncaria granule|Patients allocated to the control group take 10g of placebo of Gastrodia and Uncaria granule each time, twice per day, and for two months. The placebo has similar appearance and smell to genuine drug but has no effective anti-hypertensive agents.
15850900|NCT04035798|Drug|Memantine or placebo|BP-II patients who are older than 40 years old will be recruited, and allocate them to add-on memantine or placebo plus standard valproic acid treatment in a 1: 1 ratio. The participants will receive memantine 5mg/day or placebo treatment for 12 weeks.
15850901|NCT04035785|Drug|Kangfu Anti-inflammatory Suppository|To evaluate the short-term and long-term efficacy of traditional Chinese medicine of Kangfu anti-inflammatory suppository in reducing the use of antibiotics,reducing the risk of clinical use of drugs.
15850902|NCT04035772|Other|Wiki101 and WikiTrauma|Wiki101 is a theory-based continuing professional development course to teach healthcare professionals how to use WikiTrauma. WikiTrauma is a wiki containing implementation tools built upon the Google Sites platform.
15850903|NCT04035759|Behavioral|APPEAL|Three-session, individually administered program, with sessions spaced monthly. Optional weekly contacts with participants to support engagement in program exercises/activities.
15850904|NCT04035746|Other|Observation of microcirculation and plasticity of the brain|Assessment of microcirculation, brain plasticity and clinical function
15850905|NCT04035733|Drug|rVA576|BP subjects will be treated with 30 mg once daily rVA576 regime for 6 weeks.
15850906|NCT04035720|Other|Quantitative risk|Participants will be able to see a square box that represent the estimated risk of disease progression. They will have to elect making a therapeutic decision based on the description of the case-scenario or based on the estimated prediction as represented in the square box.
15850907|NCT04035707|Drug|Rocuronium|using rocuronium as a relaxants during general anaesthesia
15850908|NCT04035707|Drug|general volatile anaesthesia|method of anaesthesia
15850909|NCT04035694|Other|Media Aware Sexual Health - High School|Media Aware is an online media literacy and sexual health education program developed for high school students that addresses the influence of media on sexual behaviors explicitly using established message processing theory. The program consists of 4 self-paced modules each with two to three lessons. Broadly, the modules cover healthy and unhealthy relationships, sexually transmitted infections, consent, substance use, pregnancy, protection and contraception, and communication between adolescents and their partners, parents, or health providers. Users also learn media literacy skills including message deconstruction to help examine the truth behind media messages.
15850910|NCT04035681|Behavioral|Problem-Solving Therapy|Problem-Solving Therapy is a brief psychosocial intervention for management of depressive symptoms. Participants will have six, one-hour sessions with an interventionist to learn a structured approach to problem-solving.
15850911|NCT04035681|Other|Stroke-Related Health Education|The stroke-related health education program will teach participants about various topics related to stroke. Participants will have six, one-hour sessions with an interventionist to learn about different topics related to stroke.
15850912|NCT04035668|Drug|LOU064|10mg hard gelatin capsules 25mg hard gelatin capsules 50mg hard gelatin capsules
15850913|NCT04035668|Drug|Placebo|0mg hard gelatin capsule
15850914|NCT04035655|Behavioral|Coma Recovery Scale - revised|"Assessment of the level of consciousness by the dedicated Coma Recovery Scale - Revised, current gold-standard in consciousness level assessment.
~Assessment before and after the tDCS session (immediately before and after the electrophysiological assessment, see below)."
15850915|NCT04035655|Diagnostic Test|Electrophysiological recordings|"The electrophysiological assessment consisted of:
~a 5 minutes resting state high-density EEG recording
~a approximately 6 minutes auditory oddball paradigm These two procedures were administered immediately before and after the tDCS session"
15850916|NCT04035642|Radiation|IGRT 24 Gy Single dose|Previously untreated patients with prostate cancer will be treated with 24Gy in in one session.
15850917|NCT04035642|Procedure|Image-guided, volumetric intensity-modulated arc radiotherapy (IGRT-VMAT)|Patients enrolled in the study will undergo IGRT-VMAT with state-of-the-art treatment-planning and quality assurance procedures with emphasis on normal tissue sparing and delivery accuracy via the use of devices that ensure stability and beam location reproducibility.
15850918|NCT04035642|Device|Rectal balloon with air filling|A rectal balloon with air filling will be used for prostate target immobilization and anatomical reproducibility.
15850919|NCT04035642|Device|Urethral catheter loaded with beacon transponders|A urethral catheter loaded with beacon transponders will be used to ensure set-up reproducibility and online target tracking.
15850920|NCT04035629|Combination Product|MagniXene, hyperpolarized 129Xe MRI|"All subjects will undergo hyperpolarized 129-Xenon MR imaging (HP MRI) and conventional proton MR imaging of lung. Hyperpolarized 129Xe gas is prepared in a process termed spin-exchange optical pumping.
~Xenon is highly lipophilic and therefore soluble in blood and tissue, making it an excellent tool for imaging the gas in both the air spaces (gas-phase imaging) and dissolved in the lung parenchyma (dissolved-phase imaging). This solubility in combination with xenon's chemical shift properties, results in the possibility of quantifying pulmonary gas exchange and gas transport within the parenchyma.
~Additionally, previous images and lung function tests will be reviewed to compare findings and evaluate if there is a correlation between the obtained results."
15850921|NCT04035616|Dietary Supplement|microbial cell preparation [MCP]|active microbial cell preparation
15850922|NCT04035616|Other|placebo|inactive ingredient
15850923|NCT04035603|Drug|D-Cycloserine|50 mg d-cycloserine given as an augmentation agent, 70 minutes prior to three CET sessions for participants who achieved smoking cessation following open treatment.
15850924|NCT04035603|Drug|Placebo oral tablet|matching 50 mg identical placebo given as an augmentation agent, 70 minutes prior to three CET sessions for participants who achieved smoking cessation following open treatment.
15851001|NCT04035031|Drug|Forxiga 10mg|Forxiga™ 10mg, dapagliflozin 10mg, oral, once daily for 7 days (70 mg total)
15851002|NCT04035031|Drug|Placebo|Placebo tablets, starch, oral, once daily for 7 days (7 tablets total)
15851003|NCT04035018|Procedure|pharmacopuncture therapy|The participants in the treatment group will be receive one or more pharmacopuncture therapy according to the physician's decision.
15869276|NCT03887403|Other|Usual care|
15850925|NCT04035603|Behavioral|Open Phase CBT that preceeds the randomization phase|Four sessions of weekly individual cognitive-behavior therapy (CBT: a form of psychotherapy that treats problems by helping people modify thoughts, behaviors, and emotions; in this case, for the goal of smoking cessation). Session topics include educational (e.g., health risks of smoking, effectiveness of different treatment approaches), motivational enhancement (e.g., identifying personally relevant benefits of quitting, and costs of continuing to smoke), and cognitive-behavioral elements (e.g., identifying smoking triggers, developing coping strategies for these triggers, planning for high risk situations, relapse prevention).
15850926|NCT04035603|Drug|Open phase smoking cessation pharmacotherapy that proceeds the randomization phase|Initiating 2 weeks prior to quit date and continuing for 8 weeks after quit date, choice of one of three pharmacological smoking cessation aids: Nicotine Replacement Therapy (nicotine patch), Varenicline, or Bupropion.
15850927|NCT04035590|Procedure|No drain|Mastectomy with flap fixation without low vacuum drainage
15850928|NCT04035590|Procedure|With drain|Mastectomy with flap fixation with low vacuum drainage
15850929|NCT04035577|Behavioral|Mobile self-help intervention|During the trial, participants will use Intellicare apps for up to 8 weeks and will be invited to provide feedback about their experience at two follow-up time points: weeks 4 and 8. All participants will first undergo initial assessments that will include a series of online questionnaires about their mood. Eligible participants will receive up to 8 weeks of access to the IntelliCare system, which consists of apps with a variety of resources, including lessons and tools designed to teach skills for mood management. It is suggested that participants utilize the mobile phone tools every day
15850930|NCT04035564|Drug|Sodium < 1mEq/kg/day|Sodium administration enteral and/or parenteral less than 1mEq/kg/day started on day of life 1
15850931|NCT04035564|Drug|Sodium 5mEq/kg/day|Sodium administration enteral and/or parenteral 5mEq/kg/day started on day of life 1
15850932|NCT04035538|Drug|CKD-320, D012|R: D012 1tablet, QD, PO T: CKD-320 2tablets, QD, PO
15850933|NCT04035525|Dietary Supplement|MaxSimil® fish oil + CoQ10|"The intervention is a randomized double blind cross over design testing the pharmacokinetics of 1) CoQ10 combined with MaxSimil fish oil as a carrier, 2) CoQ10 combined with rice bran oil as a carrier, and 3) CoQ10 as a powder form.
~Treatments are randomly assigned on days 1, 8 and 15 of the clinical study. Blood samples will be collected at time 0, 1, 2, 4, 5, 6, 8, 10, 12, 24 and 48 hours. Each participant will perform all three treatments, with a minimum of 7 days between treatments. A questionnaire will document the side effects felt by participants."
15850934|NCT04035525|Dietary Supplement|Rice bran oil + CoQ10|"The intervention is a randomized double blind cross over design testing the pharmacokinetics of 1) CoQ10 combined with MaxSimil fish oil as a carrier, 2) CoQ10 combined with rice bran oil as a carrier, and 3) CoQ10 as a powder form.
~Treatments are randomly assigned on days 1, 8 and 15 of the clinical study. Blood samples will be collected at time 0, 1, 2, 4, 5, 6, 8, 10, 12, 24 and 48 hours. Each participant will perform all three treatments, with a minimum of 7 days between treatments. A questionnaire will document the side effects felt by participants."
15850935|NCT04035525|Dietary Supplement|CoQ10 as powder form|"The intervention is a randomized double blind cross over design testing the pharmacokinetics of 1) CoQ10 combined with MaxSimil fish oil as a carrier, 2) CoQ10 combined with rice bran oil as a carrier, and 3) CoQ10 as a powder form.
~Treatments are randomly assigned on days 1, 8 and 15 of the clinical study. Blood samples will be collected at time 0, 1, 2, 4, 5, 6, 8, 10, 12, 24 and 48 hours. Each participant will perform all three treatments, with a minimum of 7 days between treatments. A questionnaire will document the side effects felt by participants."
15850936|NCT04035512|Other|Expressive writing|"The procedure for the writing group will be as follow:
~on day 1 the researcher will call the participant at designed time and will provide a brief introduction to the writing task. Participant will be asked to go in a quiet place in their house where they would have no interruptions but can still be close to the phone. Next, participants were given standardized instructions. Then participants will ask to start writing immediately after hanging up the phone and to write for 20 minutes. The researcher will call the participants after 20 minutes. The procedure for the second and third writing days will be identical.
~The above method was previously tested by Zakowski et al., 2004."
15850937|NCT04035499|Behavioral|GO-EXCAP Mobile App|A mobile app delivery platform and the EXCAP©® exercise program
15850938|NCT04035486|Drug|Osimertinib|"Drug: Osimertinib (Oral)
~Other Names:
~AZD9291"
15850939|NCT04035486|Drug|Pemetrexed/Carboplatin|Drug: Pemetrexed (500 mg/m2) plus carboplatin (AUC5) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by Osimertinib daily with pemetrexed maintenance (500 mg/m2) every 3 weeks.
15850940|NCT04035486|Drug|Pemetrexed/Cisplatin|Drug: Pemetrexed (500 mg/m2) plus cisplatin (75 mg/m2) on Day 1 of 21day cycles (every 3 weeks) for 4 cycles, followed by Osimertinib daily with pemetrexed maintenance (500 mg/m2) every 3 weeks.
15850941|NCT04035473|Drug|HM30181 methanesulfonate monohydrate plus oral paclitaxel capsules|"HM30181 methanesulfonate monohydrate plus oral paclitaxel capsules
~Oral paclitaxel capsules"
15850942|NCT04035460|Device|Helmet|The helmet encloses the head and neck of the patient, has a rigid ring and is secured by 2 armpit braces. A soft collar adheres to the neck and ensures a sealed connection once the helmet is inflated.
15850943|NCT04035460|Device|High Flow Nasal Oxygen|Large-bore nasal prongs through which oxygen is delivered at high flow rates
15850944|NCT04035447|Behavioral|Behavioral Symptom Management for Young Adult Cancer Survivors|The hybrid intervention will include in-person group sessions along with an integrated mobile application to provide participants with instruction in cognitive and behavioral strategies for managing symptoms (i.e., pain, fatigue, distress). Investigators anticipate that the developed intervention will include 8 face-to-face group sessions (10 therapy hours). Sessions will be delivered using a faded contact approach (i.e., sessions 1-6: weekly, sessions 7-8: biweekly). Participants will receive secure access to a study-specific mobile application that will include: 1) audio and video files and brief text-based educational content reviewing strategies discussed during the groups; 2) the ability to self-monitor symptom severity; 3) the ability to connect with group members via a social networking platform; and 4) activity tracking synchronization.
15850945|NCT04035434|Biological|CTX110|CTX110 (CD19-directed T-cell immunotherapy comprised of allogeneic T cells genetically modified ex vivo using CRISPR-Cas9 gene editing components
15850946|NCT04035408|Other|Skin health assessment|Assess and measure the natural history of facial skin changes in pre and perimenopausal women undergoing chemotherapy and/or endocrine therapy for breast cancer
15850947|NCT04035395|Other|Peer-led Support Group|The Viviendo Saludable pláticas (or talks) connected Salud y Vida participants living with diabetes together. These talks served as a forum for Salud y Vida participants to share their knowledge and experiences, including some that many health workers, friends, or family do not have. Viviendo Saludable helped participants develop better strategies for managing their diabetes in their daily life. The Viviendo Saludable pláticas complement and enhance the other services by helping participants create a network of emotional, social, and practical support needed to manage diabetes and stay healthy over the long term. Classes met once a week for one hour at locations central to participants' homes.
15850948|NCT04035395|Other|Behavioral Health Consult|In a Behavioral Health consult, a participant meets with a counselor for one or more thorough meetings to talk about things that influence their health and well-being. A participant receiving a Behavioral Health consult receives support and is empowered with health coping skills that will allow for improved medication adherence and motivation to control their diabetes.
15850949|NCT04035395|Other|Medication Therapy Management Consult|Medication Therapy Management helps participants and their doctors make sure that their medications are working to improve their health. In a Medication Therapy Management (MTM) consult, a pharmacist gives participants a comprehensive review of all their medications and speaks with them about 1) how well their medications are working, 2) whether their medications have side effects, 3) if there might be interactions between the drugs their taking, 4) whether costs can be lowered and 5) other problems participants are having. The participant will get a written summary of this discussion, including an action plan that recommends what can be done to make the best use of their medications.
15850950|NCT04035395|Other|La Cocina Alegre/ The Happy Kitchen|The Happy Kitchen is a program where people come together to learn skills and self-sufficiency in preparing healthy, economical meals, laugh, cook, and enjoy food together. The cooking and nutrition program is an interactive 6-week series of classes, where the essential skills for healthy eating is taught and emphasis is placed on the selection and preparation of fresh, seasonal foods that are nutritious, economical, and delicious. Classes meet once a week for 1 ½ hours to cook, discuss, and learn together. All participants leave each class with recipes and groceries to practice new cooking skills.
15850951|NCT04035395|Other|Mind, Exercise, Nutrition, Do it!|MEND is a diet and exercise education program that helps families support their kids, ages 6-13, to reach a healthy weight. The program teaches adults and their children how to maintain energy and confidence throughout the day while learning how to cook healthy meals. Each program lasts 10 weeks and classes are 2 times per week. An adult must attend with the child.
15850952|NCT04035382|Procedure|Labor induction|The study intervention is labor induction from 39 0/7 to 39 6/7 weeks. The individual labor induction process will be at the discretion of the physician or midwife managing the subject's care. Methods of induction that may be used include misoprostol, intracervical Foley catheter, oxytocin, and/or amniotomy. Participating clinicians will be encouraged to use only one course of cervical ripening followed by oxytocin infusion and amniotomy.
15850953|NCT04035369|Procedure|Tap and Inject (TAI)|"Patients randomized to the TAI group will have a 0.2 mL vitreous specimen collected and a 0.1 mL anterior chamber paracentesis performed to be sent for standard cultures, Gram stain, and sensitivities.
~Intravitreal injection of the following antibiotics: Vancomycin 1.0 mg/0.1 mL, ceftazidime 2.25 mg/0.1 mL (amikacin 400 mcg/0.1 mL instead of Ceftazidime if severe penicillin allergy) and an intravitreal injection of dexamethasone 400 mcg/0.1 mL"
15850954|NCT04035369|Procedure|Pars Plana Vitrectomy (PPV)|Patients randomized to the PPV group will undergo a three-port PPV. The patient should be added to the OR list as an A-case (maximum 6 hours wait) and no intravitreal injection should be performed prior to the surgery. A 0.1 mL aqueous humor simple immediately before the surgery. A 0.2 mL vitreous specimen will be obtained after the sclerotomies are placed. The PPV procedure should be limited to core vitrectomy, air fluid exchange and intravitreal injections (antibiotics and dexamethasone - Vancomycin 1.0 mg/0.1 mL, ceftazidime 2.25 mg/0.1 mL or amikacin 400 mcg/0.1 mL instead of Ceftazidime if severe penicillin allergy and an intravitreal injection of dexamethasone 400 mcg/0.1 mL). Other tamponades such as silicone oil should be avoided if possible. The PPV will then be completed by the surgeon and the vitreous specimen will be sent for standard cultures, Gram stain, and sensitivities.
15850955|NCT04035356|Device|Aortic valve repair|Use of a HAART Aortic Annuloplasty Device in patients undergoing aortic valve repair surgery
15850956|NCT04035343|Behavioral|Face down positioning|See description of the face down positioning group
15850957|NCT04035343|Behavioral|Supine positioning|See description of the supine positioning group
15850958|NCT04035330|Combination Product|etidronate in sodium hypochlorite|using etidronate in sodium hypochlorite solution with a volume of 5 ml between each instrument to reach a total volume of 25 ml
15850959|NCT04035330|Combination Product|sodium hypochlorite|irrigation with 25 ml 2.5% sodium hypochlorite . 5ml between each instrument.
15850960|NCT04035317|Drug|Aesculus Hippocastanum / Horse Chestnut|Treatment for 4 months, washout of 4 weeks, then crossover for another 4 months.
15850961|NCT04035317|Drug|Placebo|Treatment for 4 months, washout of 4 weeks, then crossover for another 4 months.
15850962|NCT04035304|Other|Mindfulness Coach|"Mindfulness Coach provides 4 primary treatment components: 1) psychoeducation about PTSD and Mindfulness (e.g., What is Mindfulness?, Why Practice Mindfulness?, Mindfulness for Veterans, Benefits of Mindfulness for PTSD, Practice Challenges with PTSD, and PTSD Symptoms During Practice), 2) self-monitoring tools for tracking mindfulness practice, 3) 9 audio- guided mindfulness exercises (e.g., Mindful Breathing, Body Scan, Clouds in the Sky, etc.), and 4) reminders to regularly practice mindfulness exercises."
15850963|NCT04035291|Other|exercise|exercises,play therapy models and positioning, handling and holding principles for babies, daily routins
15850964|NCT04035278|Biological|Dengusiil|Dengusiil is provided as lyophilized powder to be reconstituted with 0.5 mL sterile water for injection (sWFI).The reconstituted vaccine is injected as a single 0.5 mL subcutaneous (SC) dose.
15850965|NCT04035278|Biological|Placebo|Placebo is supplied as a vial of lyophilized powder containing all the components of the vaccine except dengue virus serotypes (DENV1, 2, 3 and 4) to be reconstituted with 0.5 mL sterile water for injection (sWFI).The reconstituted product is injected as a single 0.5 mL subcutaneous (SC) dose.
15850966|NCT04035265|Procedure|Blood test|Carpus and fingers of non-dominating hand MRI with gadolinium contrast
15851004|NCT04035018|Procedure|Physical therapy|The participants in the control group will be receive one or more physical therapy according to the physician's decision.
15875291|NCT03840993|Drug|Placebo|IV
15850967|NCT04035252|Diagnostic Test|Carotid artery reactivity test (CAR-test)|The CAR test will be applied to stimulate the sympathetic nervous system. This thermal stimulus is known to elevate blood pressure via sympathetic pathways, so it can be used to study the vascular response to sympathetic activation. The participant will submerge their left hand in a bucket of ice water (approximately 4 degrees celcius) for 3 minutes, which is reported to be sufficient to induce a maximal dilation in the common carotid artery. At baseline and every minute after the hand is submerged in ice water, the blood pressure will be measured to check whether a sympathetic stimulation is achieved. During this test as well the carotid artery as the abdominal aorta will be visualized using ultrasound.
15850968|NCT04035239|Device|BGS goggles|BGS goggles use for 3-6 weeks
15850969|NCT04035226|Other|No intervention|No intervention will be administered as a part of this study.
15850970|NCT04035213|Behavioral|Behavior of Sleep Course|The current study will evaluate whether a semester-long course focused on sleep improves college students' sleep patterns over one semester compared to students completing a similar-level course in the same department (Psychology) at the same university.
15850971|NCT04035200|Drug|V117957 tablets|V117957 tablets taken orally at bedtime
15850972|NCT04035200|Drug|Placebo|Tablets to match V117957
15850973|NCT04035187|Drug|fast itraconazole tablet|100mg dose
15850974|NCT04035187|Drug|medium itraconazole tablet|100mg dose
15850975|NCT04035187|Drug|slow itraconazole tablet|100mg dose
15850976|NCT04035187|Drug|oral itraconazole solution|100mg dose
15850977|NCT04035174|Diagnostic Test|LTS-2 DEC patch|After 24 hours, the patch will be removed, and then the reaction of the skin under the device will be assessed : no reaction, weak reaction (< 50% skin surface under the patch), medium reaction (> 50% skin surface under the patch), and important reaction (reaction on all the surface of the skin under the patch).
15850978|NCT04035174|Diagnostic Test|Skin snips|Regarding skin snips, a reading will be done at 24 hours after incubation of the skin in saline serum during 24 hours.
15850979|NCT04035161|Combination Product|Investigational Product|2%(w/v) Chlorhexidine in 70%(v/v) Isopropyl skin preparation
15850980|NCT04035161|Other|Reference Standard|60% (v/v) 1-propanol skin preparation
15850981|NCT04035161|Combination Product|Active Comparator|ChloraPrep® SEPP® skin preparation
15850982|NCT04035161|Other|Negative Control|0.9% Normal Saline skin preparation
15850983|NCT04035148|Diagnostic Test|Cardiopulmonary exercise test|we prepared incremental treadmill exercise protocol in which the work rate increased at one-minute intervals.Transthoracic Echocardiography(TTE) : The first step non-invasive method to diagnose PHT.
15850984|NCT04035135|Drug|ANX005|investigational drug
15850985|NCT04035135|Drug|Intravenous immunoglobulin|investigational drug
15850986|NCT04035122|Other|Robotic Treatment|The Lokomat is a robotic device, consisting of a powered gait orthosis with integrated computer-controlled linear actuators at each hip and knee joint, a body weight support, and a treadmill. During the Lokomat training, the patients completed at least 30 min of treatment session.
15850987|NCT04035122|Other|Conventional Treatment|The standard physical treatment program consisted of general conditioning exercises, including warming up (e.g. calf, shoulder, and hand passive range of motion exercises), lower and upper extremity strengthening, postural control exercises. During the conventional training, the patients completed at least 30 min of treatment session.
15850988|NCT04035109|Drug|Anakinra|A single 1mg/kg subcutaneous injection (up to 100mg) of anakinra will be administered after nasal allergen challenge.
15850989|NCT04035109|Drug|Preservative-free 0.9% sodium chloride (Placebo)|A single subcutaneous injection of sodium chloride (placebo) will be administered after nasal allergen challenge.
15850990|NCT04035109|Biological|House dust mite allergen|Standardized house dust mite (Dermatophagoides farinae) allergen extract (provided by Greer Laboratories, Lenoir, NC). Participants who are sensitized to house dust mite (determined by skin prick testing) will undergo intranasal challenge with house dust mite allergen extract. All participants will undergo allergen challenge with a single allergen (house dust mite or cat hair).
15850991|NCT04035109|Biological|Cat hair allergen|Standardized cat hair allergen extract (provided by Greer Laboratories, Lenoir, NC). Participants who are sensitized to cat hair (determined by skin prick testing) will undergo intranasal challenge with cat hair allergen extract. All participants will undergo allergen challenge with a single allergen (house dust mite or cat hair).
15850992|NCT04035096|Drug|Ascorbic Acid|"Start with IVC (intravenous ascorbic acid) 25 g biweekly, 50 g biweekly, and 75 g biweekly. If the target blood level is below 350mg/dl, the dose will titrate up to 100 g/dose or maximal dose of 1.5g/kg/dose to achieve the target level.
~The final dose will be kept for 12 weeks.
~Maintenance dose: 75-100g every 2 week will be maintained for additional 12 weeks"
15850993|NCT04035096|Other|Control group|"Selection of control group: stage IV colon cancer patients match for sex, age and chemotherapy /target therapy drugs
~Usual care"
15850994|NCT04035083|Device|Laser activated irrigation|Diode laser at 980 nm, power of 1.5W, for 5 seconds inside the canal along with sodium hypochlorite, repeated 4 times with a gap of 10 seconds in between
15850995|NCT04035083|Device|Passive ultrasonic irrigation|ultrasonic activation inside the canal for 1 min
15850996|NCT04035070|Combination Product|co-amoxiclav-clindamycin solution|antibiotic-containing solution will be prepared by mixing equal quantities of 1.2gm Co-amoxiclav solution and 600mg Clindamycin solution at a ratio of 1:1 by volume to be used as a root canal irrigating solution
15850997|NCT04035070|Combination Product|MTAD|mixture of 3% doxycycline hyclate, 4.25% citric acid and detergent (Tween 80) to be used as a root canal irrigating solution
15850998|NCT04035070|Combination Product|2.5% sodium hypochlorite|It will be prepared by adding 10mL of sterile distilled water to 10mL of 5.25% sodium hypochlorite solution to be used as a root canal irrigating solution
15850999|NCT04035057|Other|Behaviorally Enhanced Training|Therapists in the Behaviorally Enhanced Training will receive the same didactic instruction as those in the Standard Didactic Training arm during the first full day of training. In the second half-day training, those in the Behaviorally Enhanced Training arm will focus on behavioral strategies (i.e., exposure to exposure) that provide direct experience with the process of treatment delivery.
15851000|NCT04035057|Other|Standard Didactic Training|Therapists in the Standard Didactic Training arm will complete training as usual, consisting of PowerPoint and video training tasks instructing the delivery of exposure therapy for anxious youth.
15851005|NCT04035005|Drug|Ocrelizumab|The first dose of ocrelizumab will be administered as two 300 mg IV infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 600 mg infusion every 24 weeks. A minimum interval of 20 or 22 weeks, depending if the previous dose was administered in one or two infusion, should be maintained between each infusion.
15851006|NCT04035005|Drug|Placebo|The first dose of placebo will be administered as two 300 mg IV infusions given 14 days apart. For the subsequent doses, placebo will be administered as a single 600 mg infusion every 24 weeks, with a minimum interval of 20 or 22 weeks, depending if the previous dose was administered in one or two infusion, should be maintained between each infusion.
15851007|NCT04034979|Behavioral|decision aid|One hour online training about shared-decision making about goals-of-care and best practices regarding goals-of-care discussions and decision-making. One hour debriefing in presence.
15851008|NCT04034966|Device|Claria telemedicine device|Use of Claria telemedicine module, which stores patient information in the cloud.
15851009|NCT04034953|Diagnostic Test|Faecal Immunochemical Test|Faecal Immunochemical Test detects if there is any hemoglobin presents in stools, so even tiny amount of blood in stool can be found.
15851010|NCT04034953|Diagnostic Test|Prostate-Specific Antigen Test|PSA blood test is used to measure the level of PSA in blood. When the PSA level is higher than normal, it may represent prostate cancer or benign prostate hyperplasia. Patient who have high PSA level should receive additional tests.
15851011|NCT04034953|Diagnostic Test|Mammogram|Each sides of breast will be taken imaging in 2 different views.The breast will be pressed between 2 plastic plates to flatten and spread the breast tissue for clear imaging.
15851012|NCT04034940|Other|Dosing Oxidative stress biomarkers & hFABP in STEMI pPCI patients|Dosing oxidative stress biomarkers and hFABP in STEMI pPCI
15851015|NCT04034914|Other|Questionnaire administration|Ancillary studies
15851016|NCT04034901|Device|Monitoring of cardiorespiratory parameters with BORA Band|"The subjects will continuously wear a connected wrist-worn pulse oximeter which will remotely collect the following measurements :
~Activity
~Step count
~Heart rate
~Respiratory rate
~Skin temperature
~SpO2"
15851017|NCT04034888|Behavioral|HEX|HEX is a customized exercise program with components including: 1) controlled flexibility movements; 2) progressive ADL training focusing on bed mobility, bed to chair transfers, and indoor walking; 3) task-specific seated resistance training to improve ability to get out of bed and; 4) and balance exercises. Participants will be expected to perform their HEX program at least 2 times/week in their home and all individualized exercise sessions will be supervised by an Exercise Physiologist. Each exercise has four levels of difficulty, which will be progressed as tolerated throughout the 12-weeks. Seated resistance exercises were designed to target all the major muscle groups and will include the following: arm curls, shoulder raises (lateral/front), overhead arm raise, wrist curls, leg extensions, hip flexion, hip ab/adduction, sit-to-stands, torso rotation, and marching.
15851018|NCT04034875|Other|Questionnaire|questionnaire
15851019|NCT04034862|Drug|Treatment simplification (dolutegravir lamivudine)|Switch from 3 drug regimen (DTG/ABC/3TC) to 2 drug regimen
15851020|NCT04034849|Radiation|Photobiomodulation|Photobiomodulation whit Low-Level Laser Therapy
15851021|NCT04034849|Radiation|Placebo|Device turned off
15851022|NCT04034836|Drug|Scalp blocks with ropivacaine plus parecoxib|Scalp blocks with ropivacaine 0.75% wt/vol, 20ml, plus 10 mg parecoxib (diluted in 2 mL NS) with epinephrine at 1:200,000 (5 ug/mL) and i.v. saline 2ml;An independent researcher will prepare the study solution in a separate operating room. The study solutions with syringes (50-ml) for the scalp blocks and syringes (5-ml) for intravenous injection are prepared and numbered with a 23-gauge needle by an independent researcher, after opening the envelope containing the allocation of treatment. After induction, the assigned solutions will be injected subcutaneously or intravenously separately by the anesthesiologist. The scalp blocks will be performed along the lines of the technique previously described by Pinosky et al. The following nerves were blocked bilaterally: the supraorbital and supratrochlear nerves; the zygomatico-temporal nerves; the auriculotemporal nerves; the postauricular branches of the greater auricular nerves; the greater, lesser, and third occipital nerves.
15851023|NCT04034836|Drug|Scalp blocks with ropivacaine and intravenous parecoxib|Scalp blocks with ropivacaine 0.75% wt/vol, 20ml, plus saline 2ml with epinephrine at 1:200,000 (5 ug/mL) together with 10 mg parecoxib (diluted in 2 mL NS) intravenously. An independent researcher will prepare the study solution in a separate operating room. The study solutions with syringes (50-ml) for the scalp blocks and syringes (5-ml) for intravenous injection are prepared and numbered with a 23-gauge needle, after opening the envelope containing the allocation of treatment. After induction, the assigned solutions will be injected subcutaneously or intravenously separately by the anesthesiologist. The scalp blocks will be performed along the lines of the technique previously described by Pinosky et al. The following nerves were blocked bilaterally: the supraorbital and supratrochlear nerves; the zygomatico-temporal nerves; the auriculotemporal nerves; the postauricular branches of the greater auricular nerves; the greater, lesser, and third occipital nerves.
15851024|NCT04034836|Drug|Scalp blocks with ropivacaine and intravenous saline|Scalp blocks with ropivacaine 0.75% wt/vol, 20ml, plus saline 2ml with epinephrine at 1:200,000 (5 ug/mL) and i.v. saline 2ml. An independent researcher will prepare the study solution in a separate operating room. The study solutions with syringes (50-ml) for the scalp blocks and syringes (5-ml) for intravenous injection are prepared and numbered with a 23-gauge needle by an independent researcher, after opening the envelope containing the allocation of treatment. After induction, the assigned solutions will be injected subcutaneously or intravenously separately by the anesthesiologist. The scalp blocks will be performed along the lines of the technique previously described by Pinosky et al. The following nerves were blocked bilaterally: the supraorbital and supratrochlear nerves; the zygomatico-temporal nerves; the auriculotemporal nerves; the postauricular branches of the greater auricular nerves; the greater, lesser, and third occipital nerves.
15851025|NCT04034823|Biological|KN035|KN035 5 mg/kg s.c. Q3W
15851026|NCT04034823|Biological|Trastuzumab|8 mg/kg IV loading followed by 6 mg/kg Q3W IV
15851027|NCT04034823|Drug|Docetaxel|100 mg/m2 Q3W IV
15851028|NCT04034810|Device|Intracranial aneurysm treated with Silk vista and silk vista baby|Patients with intracranial aneurysm(s) intended to be treated with the silk vista and silk vista baby according to standard of care.
15851479|NCT04031066|Drug|Placebo|infusion i.v. treatment
15851029|NCT04034797|Other|Photography teletransmission|A photography of the trauma is teletransmitted to SAMU's physician
15851030|NCT04034797|Other|No photo|Usual management without photography teletransmission
15851031|NCT04034784|Device|Discrete(TM)|A designated volume of Discrete(TM) (according to cohort) is applied intraperitoneally
15851032|NCT04034784|Other|Control Lactated Ringer's Solution (Control LRS)|A designated volume of LRS (according to cohort and equivalent to volume of Discrete(TM)) is applied intraperitoneally
15851033|NCT04034771|Drug|Melatonin 10 MG Oral Tablet|Melatonin tablets
15851034|NCT04034771|Drug|Propofol|propofol amp
15851035|NCT04034771|Drug|Placebo oral tablet|sugar pill manufactured to mimic melatonin tablets
15851036|NCT04034758|Procedure|Standardized Quantitative multi-donor Intestinal Microbiota Capsule (SQIMC-md)|heterologous fecal microbiota transplantation (FMT) by Standardized Quantitative multi-donor Intestinal Microbiota Capsule (SQIMC-md)
15851037|NCT04034758|Procedure|placebo capsule|Oral administration of 30 placebo capsule containing edible pigmented starch
15851038|NCT04034745|Drug|telotristat ethyl|250 mg tablets of Xermelo (telotristat ethyl) is administered orally 3x daily in combination with somatostatin analogs (SSAs) for approximately 84 days as per standard of care
15851039|NCT04034732|Behavioral|Mindfulness-based Relapses Prevention (MBRP)|"Manualized MBRP program is used with a central theme in each session, with meditation practices and relapse prevention exercises and discussions. Themes include the concept of automatic pilot and its relationship to addiction relapse, recognizing thoughts and emotions in relation to triggers of relapse, integrating mindfulness practices into daily activities, practicing mindfulness in high risk situations and the role of thoughts and emotions in relapse. Include daily homework exercises that consist of awareness exercises directed at increasing non-judgmental awareness of bodily sensations, thoughts and feelings, together with exercises designed to integrate awareness skills into daily life. Include training in mindfulness through body scan, sitting meditation, and mindful stretching exercises, to cultivate awareness during simple stretching movement."
15851040|NCT04034732|Behavioral|Usual Care Control|Participants in the UCCG condition will remain in their standard outpatient aftercare provided by the treatment agency with an aim to maintain their abstinence with the help from social workers or other healthcare professionals through different activities, such as topics on life training skills such as rational thinking skills, grief and loss, assertiveness, self esteem, goal setting, effects of drugs on interpersonal relationships and experience. Frequency of their visits to / contacts with healthcare professionals will be recorded.
15851041|NCT04034719|Other|portage scarf|Parents will be carried their newborn with the portage scarf provided by the department.
15851042|NCT04034719|Other|usual practice|Parents will be carried their newborn as their usual practice.
15851043|NCT04034706|Other|DEXA|DEXA Scans will be performed to measure body fat and estimate muscle mass using a General Electric Lunar iDXA whole-body scanner.
15851044|NCT04034706|Other|Magnetic Resonance (MR) Assessment of the Abdomen|Include measures to assess liver lipid content and stiffness and perform volumetric fat quantitation.
15851045|NCT04034706|Other|MR assessment of Whole Body Fat|Volumetric measurement of fat, muscle and bone
15851046|NCT04034706|Procedure|Adipose tissue biopsy|0.5 cm incision of the upper-outer right vastus lateralis, and either a 3-4mm Mercedes Liposuction needle, or a 4-6 mm Bergstrom needle will be inserted to aspirate approximately 7 grams of adipose tissue.
15851047|NCT04034706|Other|Oral glucose tolerance test|Glucose tolerance will be assessed with a 75 g oral glucose tolerance test (OGTT). Subjects will be studied after an overnight fast.
15851048|NCT04034693|Device|Smartphone-delivered CBT for BDD|12-week Smartphone-delivered CBT for BDD. In-person cognitive behavioral therapy (CBT) is an empirically supported treatment for BDD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., exposure with ritual prevention), and perceptual retraining/mindfulness skills.
15851049|NCT04034680|Other|TIME|The intervention of the TIME model includes two hours of lectures about dementia and NPS and three hours of training and roleplay in using TIME. The staff of the home care service will receive the TIME manual and access to the TIME website with access to additional educational materials. From each municipality, three staff members called TIME administrators, will receive additional three hours of lectures and roleplay in TIME, and will thereafter have the responsibility for performing the intervention.
15851050|NCT04034680|Other|Education-only intervention|Staff in the home care service in municipalities in the control group will receive thesame two hours lectures about dementia and NPS as the intervention grorp. After the cluster RCT pilot study is ended, municipalities in the control group will receive the same three-hour lessons in the TIME as the intervention group of municipalities.
15851051|NCT04034667|Other|No intervention|No intervention
15851052|NCT04034654|Other|Questionaire|Child behavior checklist is a questionaire, designed to evaluate 1.5-5 years old child's behavior. The checklist is filled out by parents/caregivers.
15851053|NCT04034641|Drug|Bifidobacterium tetrad live bacteria tablet plus Helicobacter pylori quadruple eradication therapy|On day 1-14: Standard therapy: esomeprazole magnesium enteric-coated tablets, amoxicillin granules (A Mo Xian), furazolidone tablets, bismuth potassium citrate granules (Li Zhu De Le) are taken twice a day, once in the morning and once in the evening. Esomeprazole magnesium enteric-coated tablets and bismuth potassium citrate granules (Li Zhu De Le) should be taken 30min before meal; amoxicillin granules (A Mo Xian) and furazolidone tablets should be taken 30min after meal. Probiotic: Bifidobacterium tetrad live bacteria tablets should be taken at noon once a day (30 min after meal ), 9 tablets per time. On day 15-28: Probiotic: Bifidobacterium tetrad live bacteria tablets, taken at noon once a day (30min after meal), 9 tablets per time.
15851054|NCT04034641|Drug|Bifidobacterium tetrad live bacteria tablet placebo plus Helicobacter pylori quadruple eradication therapy|On day 1-14: Standard therapy: esomeprazole magnesium enteric-coated tablets, amoxicillin granules (A Mo Xian), furazolidone tablets, bismuth potassium citrate granules (Li Zhu De Le) are taken twice a day, once in the morning and once in the evening. Esomeprazole magnesium enteric-coated tablets and bismuth potassium citrate granules (Li Zhu De Le) should be taken 30min before meal; amoxicillin granules (A Mo Xian) and furazolidone tablets should be taken 30min after meal. Placebo: Bifidobacterium tetrad live bacteria tablet placebos should be taken at noon once a day ( 30 min after meal ), 9 tablets per time. On day 15-28: Placebo: Bifidobacterium tetrad live bacteria tablet placebos, taken at noon once a day (30min after meal), 9 tablets per time.
15851055|NCT04034628|Device|Peritoneal Catheter Insertion - Laparoscopic|Insertion of a Peritoneal Catheter into the abdomen for the purposes of treating kidney failure
15851056|NCT04034628|Device|Peritoneal Catheter Insertion - Percutaneous|Insertion of a Peritoneal Catheter into the abdomen for the purposes of treating kidney failure
15851057|NCT04034615|Biological|Mesenchyme Stem Cells low-dose group|Participants will receive transdermal one dose of 1*10^6 cells of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous three days and then receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous next three days.
15851058|NCT04034615|Biological|Mesenchyme Stem Cells high-dose group|Participants will receive transdermal one dose of 1*10^6 cells of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days.
15851059|NCT04034615|Biological|Placebo|Participants will receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days.
15851060|NCT04034602|Other|vibration group|plantar vibration group is supine position, plantar vibration will be applied to both foot of each patient with a vibration device with a frequency of 15-100 Hz over 5 minutes.
15851061|NCT04034602|Other|placebo group|the placebo group, both sides will be held in the supine position under the soles of the foot for 5 minutes each so that the device is in contact with the foot without vibration.
15851062|NCT04034589|Drug|Pyrotinib combined with fulvestrant|Pyrotinib 400 mg once daily; Fulvestrant 500 mg administered on days 0, 14 (plus or minus 3 days), 28 (plus or minus 3 days), and every 28 (plus or minus 3 days) days
15851064|NCT04034563|Procedure|1) Risk of metachronous advanced neoplasia at 3-year, beyond 3 years surveillance colonoscopy|"3-year group: High-risk subjects who have baseline colonoscopy done in 2014, 2015 and 2016 and will be eligible for 3-year surveillance colonoscopy in 2017-2019.
~Beyond 3 years group: High-risk subjects who had screening colonoscopy prior 3 years, but not received or scheduled for a surveillance colonoscopy- either due to non-adherence or limited access to surveillance colonoscopy will be eligible for surveillance colonoscopy in 2017-2019.
~For the surveillance interval beyond 3 years group, recruitment will be prioritizing to subjects who had the screening colonoscopy at the earliest date. This will in part ensure that subjects in this group will consist those with the longest surveillance interval, leading to an applicable estimation of the risk of metachronous advanced neoplasia beyond 3 years surveillance interval."
15851065|NCT04034550|Other|Blood and urine sampling and blood banking|In routine management, blood and urine will be sampled for each patients and specific analyses carried out. Only blood samples will be banked.
15851066|NCT04034537|Diagnostic Test|cPSTA|The cPSTA System is a medical device system that uses passive tomography to analyze a patient's phase space data to identify the presence of significant coronary artery disease. The cPSTA System consists of several components that work together to obtain, transmit, analyze the data, and display the results, including the Phase Signal Acquisition System (PSAQ System), which is the Phase Signal Recorder (PSR) and the Phase Signal Data Repository (PSDR); analytical software; and secure web portal. For this study only the PSAQ System is used by the clinical site for the purposes of acquiring and transmitting the signal. All enrolled patients will perform cPSTA signal recording.
15851067|NCT04034524|Drug|GLP-1 receptor agonist|any GLP-1 receptor agonist (other than Saxenda or liraglutide 3.0mg)
15851068|NCT04034524|Drug|Insulin|glargine, detemir, neutral protamine Hagedorn (NPH), degludec
15851069|NCT04034511|Other|Medically-tailored meal delivery and medical nutrition therapy|Home-delivered, medically-tailored meals for 3 months combined with monthly individual medical nutrition therapy sessions for 6 months
15851070|NCT04034485|Drug|lerodalcibep|PCSK9 inhibitor
15851071|NCT04034485|Drug|evolocumab|PCSK9 inhibitor
15851072|NCT04034472|Other|Interdisciplinary intervention in obesity|Interdisciplinary weight loss intervention associate to the use of digital technology to treat obesity and related disorders
15851073|NCT04034459|Drug|Bevacizumab|Bevacizumab 5 mg/kg BW iv over 30 to 90* min day 1
15851074|NCT04034459|Drug|Irinotecan|Irinotecan 150 mg/m² iv, 30 - 90 min. day 1
15851075|NCT04034459|Drug|Folinic acid|Folinic acid (racemic) 400 mg/m² iv, 120 min. day 1
15851076|NCT04034459|Drug|Oxaliplatin|Oxaliplatin 85mg/m² day 1
15851077|NCT04034459|Drug|5-FU|5-FU 3000 mg/m² iv over 48 h days 1-2
15851078|NCT04034459|Drug|Cetuximab|Cetuximab initially 400 mg/m² with infusion rate of ≤5 mg/min., subsequently 250 mg/m² iv with infusion rate of ≤10 mg/min. days 1+8
15851079|NCT04034446|Biological|CD19-CD22 CAR-T cells|0.5 to 3.0 x 106 autologous CD19-CD22 CAR-T cells per kg body weight, with a maximum dose of 4 x 108 autologous CD19-CD22 CAR-T cells via intravenous infusion.
15851080|NCT04034433|Procedure|Handgrip exercise program|Handgrip exercise with a rubber ball 4 weeks before the surgery until 4 weeks after the surgery 20 contractions per minute for a total of 20 minutes each day.
15851081|NCT04034420|Other|Online training platform|Self-paced training and learning materials in relation to family services
15851082|NCT04034407|Procedure|Damage control surgery|"All patients with clinical and radiological suspicion of colonic perforation and generalized Peritonitis with indication for emergency surgery were included in the study.
~Randomisation was performed intraoperatively in all patients after the performing surgeon confirmed a colonic perforation with generalized peritonitis."
15851083|NCT04034394|Other|Electromoxibustion|Electromoxibustion is a electric device that mimic the burning or moxa. Subjects in this group will receive electromoxibustion using a knee-brace-like device which produces thermal stimulation with a moxa pad inside. The treatment will be delivered 3 times per week for 4 weeks.
15851084|NCT04034394|Other|Knee health education|Subjects in this group will attend 2 lessons (120 minutes each) of health education related to knee OA symptom management in a small group of 5-7 subject. The course content is developed from the course materials from the websites of Elderly Health Service, Department of Health, Hong Kong SAR.
15851085|NCT04034381|Other|No intervention (descriptive survey only)|No intervention
15906749|NCT03597217|Drug|Placebo|Placebo
15851086|NCT04034368|Drug|Tenofovir Alafenamide (TAF)|Tenofovir alafenamide (TAF) 25 mg QD, oral administration, 48 weeks；
15851087|NCT04034355|Drug|Calmangafodipir (5 µmol/kg)|PledOx will be given to patients as an i.v. infusion, on top of mFOLFOX6 chemotherapy. PledOx is a bright yellow clear solution in 20 mL colorless, single dose, glass vials.
15851088|NCT04034355|Other|Placebo|Placebo will be administered via the same route as PledOx (i.v. infusion). Placebo is a bright yellow clear solution in 20 mL colorless, single dose, glass vials.
15851089|NCT04034342|Other|RaceRunning|RaceRunning (www.racerunning.org) is a growing disability sport that provides an opportunity for people with moderate-to-severe CP to participate in exercise in the community. It allows those who are unable to walk independently, to propel themselves using a RaceRunning bike, which has a breastplate for support but no pedals. Participants sit on the saddle and use their legs to propel themselves forward.
15851090|NCT04034329|Procedure|ASVAL|Ambulatory Selective Varices Ablation under Local Anesthesia
15851091|NCT04034329|Procedure|EVLA|Endovenous Laser Ablation
15851092|NCT04034316|Other|Cord-blood mesenchymal stromal cells|The product is packaged in bags suitable for the cryopreservation of cell products. Before administration the cells must be thawed and diluted in an appropriate vol:vol solution: made by saline 78%, human albumin 10%, Acyl-CoA dehydrogenase-A (ACD-A) 12%.
15851093|NCT04034303|Genetic|analysis of genetic and epigenetic risk factors|analysis of gene, methylation and expression, microbiome
15851094|NCT04034290|Biological|GamFluVac|The drug is a vaccine that induces high-level immunity against influenza A viruses
15851095|NCT04034290|Other|Placebo|Placebo
15851096|NCT04034277|Other|Lee Silverman Voice Therapy|LSVT LOUD® comprises maximum effort non-speech and speech drills. The non-speech drills include the production of 15 sustained 'ah' phonation at high volume and pitch glides (5 repetitions moving from modal pitch to high pitch and 15 repetitions moving from modal pitch and going down on production of sustained 'ah'). The speech drills utilize a hierarchy of speech tasks moving from single words through phrases and onto conversational speech to generalize
15851097|NCT04034277|Other|Conventional Treatment|"speech rehabilitation protocol comprehend:
~Respiratory and phonatory exercises: exercises to increase diaphragmatic and respiratory functions, exercises to increase expiration time using natural expiration or sibilant, exercise to increase phonation time by pronouncing the vocal /a/, exercise to reduce oral stiffness.
~Articulation and prosody exercises: repetition or reading lists of possibly long and complex words that start with or contain consonants groups. Read aloud texts, sentences or words, making sure to articulate and pronounce the words well without diminishing or increasing the rhythm of speech, with the correct punctuation and intonation. If necessary, ask patients to hyperarticulate, accelerate or slow down, or exaggerate intonation."
15851098|NCT04034251|Drug|Paclitaxel|Paclitaxel (IP and IV), Day 1 of each 3-week cycle: Paclitaxel IP - Intraperitoneal paclitaxel (60 mg/m2) will be diluted in 500 mL of 0.9% NS, to be infused as rapidly as tolerated once per 3-week cycle on Day 1. Paclitaxel IV - Intravenous paclitaxel (80 mg/m2) will be administered concomitantly over 3 hours, diluted in 100 to 250 ml of 0.9% NS once per 3-week cycle on Day 1.
15851099|NCT04034251|Drug|Capecitabine|Day 1-15 of each 3-week cycle: oral capecitabine (825 mg/m2) to be taken twice a day starting the evening of Day 1 of each cycle until the morning of Day 15, followed by a 7-day rest period during each 3-week cycle.
15851100|NCT04034251|Device|BardPort Titanium Implanted Port with Peritoneal Catheter|After peritoneal chemo infusion port is placed (Days 1-3, as dictated by clinical status), patients will begin intraperitoneal paclitaxel and intravenous paclitaxel (Day 1) followed by oral capecitabine on the evening of Day 1 to the morning of Day 15.
15851101|NCT04034238|Drug|LMB-100|Arms 1 and 2: Administered IV as an approximate 30-minute infusion of each 21 day cycle on days 4, 6 and 8 until disease progression, intolerance or withdrawal from study.
15851102|NCT04034238|Drug|Tofacitinib|Arms 1 and 2: Administered orally twice daily on days 1-10 of each cycle until disease progression, intolerance or withdrawal from study.
15851103|NCT04034238|Device|Mesothelin Expression|Test for mesothelin expression in tumor tissues for study eligibility
15851104|NCT04034225|Drug|SNS-301|Day 0, Week 3, Week 6, Week 9 then every 6 weeks (±3 days) for 6 additional doses, thereafter every 12 weeks (±3 days) up to 24 months.
15851105|NCT04034225|Drug|Pembrolizumab|Pembrolizumab (200 mg dose) IV infusion will be administered over 30 minutes every 3 weeks up to 24 months or Pembrolizumab (400 mg dose) IV will be administered over 30 minutes every 6 weeks up to 24 months.
15851106|NCT04034212|Other|Singing for Lung Health group attendance|Singing for Lung Health is a group singing intervention designed for people with chronic lung diseases. Participants would attend weekly sessions lasting 1 hour.
15851107|NCT04034199|Drug|Denosumab|Denosumab is a human monoclonal antibody against receptor activator of nuclear factor kappa-B ligand (RANKL) and its use is associated with a reduced risk of vertebral, non-vertebral and hip fracture in post-menopausal women. RANKL plays a crucial role in the pathogenesis of glucocorticoid-induced osteoporosis (GIOP). Its production is increased by GC, resulting in stimulated osteoprotegerin ligand production and increased bone resorption. Recent randomized controlled trial from Saag et al have shown that denosumab is more efficacious than risedronate in the improvement of BMD in GIOP patients. Denosumab has been confirmed efficacious in GIOP patients but its efficacy in high-risk osteopenia patients are not well studied. It is given subcutaneously at 60mg every 6 months.
15851108|NCT04034199|Drug|Zoledronic Acid|Zoledronic acid belongs to bisphosphonates and is licensed for the treatment of GIOP and 2 RCTs found zoledronic acid has superior efficacy in improvement in BMD at lumbar spine or femoral neck at 12 months when compared to risedronate. It is given intravenously every year at a dosage of 5mg.
15851109|NCT04034173|Drug|Panitumumab|"Panitumumab 6 mg/kg BW as 60-min i.v. infusion* D1
~*If the 1st infusion is well tolerated, all subsequent infusions can be applied over 30-60 minutes."
15851110|NCT04034173|Drug|Irinotecan|Irinotecan 180 mg/m² BSA i.v., 30 - 90 min D1
15851111|NCT04034173|Drug|Folinic acid|Folinic acid (racemic) 400 mg/m²BSA i.v., 120 min D1
15851112|NCT04034173|Drug|5-FU|5-FU 400 mg/m² BSA, bolus, D1 5-FU 2400 mg/m² BSA i.v. infusion over a period of 46 h D1-2
15851131|NCT04034056|Drug|Obinutuzumab|Induction phase: 1000 milligram (mg) intravenously (IV) on Day 1, 8, 15 of Cycle 1 an Day 1 of Cycles 2-6 or 2-8. Maintenance phase: 1000 mg IV every 2 months for 2 years or until disease progression (whatever occurs earlier).
15851298|NCT04032678|Device|Schiller Defigard Touch 7 - DGT7, Schiller Medical, France|Cardioversion with a pulsed biphasic waveform
15851113|NCT04034160|Other|vegetarian burger|"A finger prick test will be used to determine baseline levels measurements for serum lipids, glucose, and hs-CRP levels. Group 1 will be given vegetarian burgers to consume. Participants will need to remain in the room for 2 hours, postprandial (they may study, watch a movie, etc). They will not be allowed to consume anything except for water during this time. After consumption of burger, at 30 min, 60 min, 120 min, finger prick tests will be used to obtain blood. Participants will also be asked to try and identify the burger they consumed and rate the taste of the burger. Visit 2 will take approximately 3 hours.
~Participants will be directed to fast for 8 hours prior to Visit 3 (the following week).
~Visit 3: We will repeat the same procedure as Visit 2. However, this time the burgers will be switched."
15851114|NCT04034160|Other|beef burger|"A finger prick test will be used to determine baseline levels measurements for serum lipids, glucose, and hs-CRP levels. Group 2 will be given beef burgers to consume. Participants will need to remain in the room for 2 hours, postprandial (they may study, watch a movie, etc). They will not be allowed to consume anything except for water during this time. After consumption of burger, at 30 min, 60 min, 120 min, finger prick tests will be used to obtain blood. Participants will also be asked to try and identify the burger they consumed and rate the taste of the burger. Visit 2 will take approximately 3 hours.
~Participants will be directed to fast for 8 hours prior to Visit 3 (the following week).
~Visit 3: We will repeat the same procedure as Visit 2. However, this time the burgers will be switched."
15851115|NCT04034134|Drug|Jaktinib Hydrochloride Tablets|50 mg twice-daily (BID)
15851116|NCT04034134|Drug|Jaktinib Hydrochloride Tablets|150 mg quaque die (QD)
15851117|NCT04034134|Drug|Jaktinib Hydrochloride Tablets|200 mg quaque die (QD)
15851118|NCT04034121|Device|DESolve Cx drug eluting coronary scaffold system|percutaneous coronary intervention
15851119|NCT04034108|Procedure|Surgical intervention combined with weight-supported ambulation training|"Surgeries were performed between 12 hours to 30 days after trauma. Internal fixation was implemented once instability of the injured spinal column was confirmed by radiology and exploration during operation. At 15 days after surgery, the patients were encouraged to start weight-supported ambulation training under careful protection by the trainers, the patients were encouraged to start weight-supported ambulation training under careful protection by the trainers. The training program was named Kunming Locomotor Training Program (KLTP)formulated by actively walking for a duration of 6 hours per day, 6 days per week for a minimum of 6 months."
15851120|NCT04034095|Drug|Androgen-deprivation Therapy (ADT)|Participants enrolled in this study will continue to receive ADT (example- Leuprorelin, Goserelin and Degarelix) alone or in combination with other therapies in routine clinical practice as directed by their treating physician. No intervention will be administered as a part of this study.
15851121|NCT04034095|Drug|Bicalutamide|Participants enrolled in this study will continue to receive bicalutamide along with ADT in routine clinical practice as directed by their treating physician. No intervention will be administered as a part of this study.
15851122|NCT04034095|Drug|Abiraterone|Participants enrolled in this study will continue to receive abiraterone in combination with prednisolone along with ADT in routine clinical practice as directed by their treating physician. No intervention will be administered as a part of this study.
15851123|NCT04034095|Drug|Prednisolone|Participants enrolled in this study will continue to receive prednisolone in combination with abiraterone along with ADT in routine clinical practice as directed by their treating physician. No intervention will be administered as a part of this study.
15851124|NCT04034095|Drug|Docetaxel|Participants enrolled in this study will continue to receive docetaxel along with ADT in routine clinical practice as directed by their treating physician. No intervention will be administered as a part of this study.
15851125|NCT04034095|Drug|Enzalutamide|Participants enrolled in this study will continue to receive enzalutamide along with ADT in routine clinical practice as directed by their treating physician. No intervention will be administered as a part of this study.
15851126|NCT04034095|Drug|Apalutamide|Participants enrolled in this study will continue to receive apalutamide along with ADT in routine clinical practice as directed by their treating physician. No intervention will be administered as a part of this study.
15851127|NCT04034082|Device|Intermittent hypoxia therapy|Intermittent Hypoxic Therapy (further referred to as IHT). A typical IHT session consists of repeated short-term moderate hypoxia (down to 10 vol.% O2), interrupted by brief periods of reoxygenation. These periods of recovery could be either normoxic (21 vol.% O2, Hypoxia-Normoxia mode) or hyperoxic (30-35 vol.% O2, Hypoxia-Hyperoxia mode, further referred to as IHHT). The gas mixtures are supplied to a patient via facial mask.
15851128|NCT04034082|Other|Conventional phase 2 cardiac rehabilitation programme|The core components of a Phase 2 in-hospital cardiac rehabilitation program include: 1) patient assessment with medical control to promote clinical stabilization and optimization of pharmacologic treatment; 2) physical activity counselling; 3) prescription of an individualized exercise training; 4) diet/nutritional counselling; 5) weight control management; 6) Lipid management; 7) blood pressure monitoring and management; 8) smoking cessation; 9) vocational support; 10) psychosocial management..
15851129|NCT04034069|Device|Theta burst stimulation (TBS)|Theta burst stimulation (TBS) is a potent form of repetitive transcranial magnetic stimulation (rTMS). Standard 600-pulse intermittent theta burst stimulation (iTBS) can enhance the corticomotor excitability, whereas standard 600-pulse continuous theta burst stimulation (cTBS) can suppress the corticomotor excitability. Sham stimulation uses an extreme low stimulation intensity which will not influence with corticomotor excitability. In the present study, real stimulation will be delivered in an intensity of 70% individual resting motor threshold while sham stimulation will be delivered in an intensity of 20% individual resting motor threshold.
15851130|NCT04034069|Behavioral|Robot-assisted training|Fourier M2 upper limb rehabilitation robot (Fourier Intelligence Co. Ltd., Shanghai, China), will be used for upper limb proximal joints training. Fourier M2 upper limb rehab robot is an end-effector robot-assisted device. The device targets (1) flexion and extension of shoulder joint, (2) flexion and extension of elbow, (3) internal and external rotation of shoulder joint, and (4) abduction and adduction of shoulder joint, supported by tailored interactive TV games in the device. HandyRehab hand robot (Zunosaki Company Ltd., Hong Kong SAR) will be used for upper limb distal joints training. It is an exoskeleton over the hand which provides power-driven extension and grasping force to the fingers and thumb in order to assist the patient to open and close the paretic hand by means of surface electromyography-triggered from the signals through the forearm extensors and flexors.
15851955|NCT04027127|Other|netrin-1 value on admission to hospital|
15851132|NCT04034043|Device|ceramic-on-ceramic total hip arthroplasty|ceramic-on-ceramic, cementless total hip arthroplasty for post-traumatic hip osteoarthritis.
15851133|NCT04034030|Device|Transcranial Magnetic Stimulation|"Each patient will receive a 10 minute treatment of one time stimulation of the Epileptogenic Cortical Area (ECA). The TRPMS cap will be worn over the previously fixed scalp EEG electrodes. The procedure during this treatment session will consist of positioning a device microstimulator component centered on an area of focal epileptiform discharges (identified with EEG electrode placement) with the patient relaxing in a chair.
~The stimulus parameters used will be 120 stimulus trains of 100 ms in duration, each train delivered every 5 s for total session duration of 10 min. . The investigators will measure the subject for adequate placement of the device prior to stimulation. Once the placement of the device is confirmed, the study technician administrating the treatment will turn on the device using the app downloaded on an electronic device connected by Bluetooth to the device."
15851134|NCT04034017|Other|no intervention|descriptive study, no intervention
15851135|NCT04034004|Behavioral|Mindfulness|A well-validated brief meditation-based mental training regimen [four sessions; 20 min/session] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
15851136|NCT04034004|Drug|Naloxone|A 0.15 mg/kg bolus dose of naloxone (Naloxone hydrochloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion will cease till the end of the experiment.
15851137|NCT04034004|Other|Saline|A 0.15 mg/kg bolus dose of saline in 25ml normal saline will be administered over 10 minutes. The investigators also will administer a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion will cease till the end of the experiment.
15851138|NCT04034004|Behavioral|Meditation|A well-validated brief meditation-based mental training regimen [four sessions; 20 min/session] is used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
15851139|NCT04033991|Drug|Sunitinib|Tyrosine kinase inhibitor, licensed for use in treatment of renal cell carcinoma.
15851140|NCT04033991|Drug|Axitinib|Tyrosine kinase inhibitor, licensed for use in treatment of renal cell carcinoma.
15851141|NCT04033978|Behavioral|Cognitive remediation|10 sessions dealing with emotion recognition, jumping to conclusion, attributional style.program lasts 10 weeks
15851142|NCT04033978|Behavioral|psychosocial rehabilitation|10 sessions dealing psychosocial rehabilitation, neuropsychological evaluation, stigmatization, recovery process and severe mental disorders in general.
15851143|NCT04033965|Genetic|Corellation of Mutations, TILs and Age in Breast Cancer|
15851144|NCT04033952|Behavioral|Strategy Training|This approach is different from traditional direct skill training, which emphasizes clinicians' responsibility on identifying their patients' challenges in performing activities and teaching patients task-specific problem-solving strategies. Strategy training, on the other hand, requires clinicians to take a role as a facilitator, guiding participants to learn through prompts and questions. In the training process, participants learn to develop their own problem-solving strategies and work through the problems they have, through which they can develop self-efficacy and confidence to manage participation challenges. Participants can also generalize the strategies they learn to other similar problems they encounter in daily life.
15851145|NCT04033939|Drug|HSK3486|
15851146|NCT04033939|Drug|Propofol|
15851147|NCT04033939|Drug|Placebo|
15851148|NCT04033926|Drug|KZR-616|Subcutaneous 30 mg weekly for 2 weeks, then 45 mg weekly for 14 weeks
15851149|NCT04033926|Drug|Placebo|Subcutaneous injection for 16 weeks
15851150|NCT04033913|Other|Self questionnaire|Patients who have successfully perform self-catheterization complete a self questionnaire on the importance of each criterion in choosing the catheter they have made.
15851151|NCT04033900|Device|Forced air warming devices|"In the treatment group, heating will be started with a pre-surgical forced-air blanket Outpatient Warming Blanket model 11101 Bair Hugger from 3M and a forced-air heating unit Bair Hugger Warming Unit Model 775 from 3M at 38-43º C which will be maintain during the stay in the pre-surgery room until the transfer to the operating room"
15851152|NCT04033887|Diagnostic Test|13 Rapid Diagnostic Tests and reference tests|"Rapid diagnostic tests:
~HCV antibody test (under development); bioLytical Laboratories
~DPP® HCV (under development); Chembio Diagnostic Systems
~HCV-Ab Rapid Test; Beijing Wantai Biological Pharmacy Enterprise
~Rapid Anti-HCV Test; InTec
~First Response HCV Card Test; Premire Medical Corporation
~Signal HCV Ver 3.0; Arkray healthcare
~TRI DOT HCV; J. Mitra & Co
~Triplex HIV, HCV, HBsAg; Biosynex SA
~Standard Q HCV Ab; SD Biosensor
~HCV Hepatitis Virus Antibody Test; Artron Laboratories
~SD Bioline HCV; Abbott Diagnostics
~OraQuick HCV; OraSure
~Care Start HCV Rapid Test (under development); Access Bio
~Reference tests:
~Enzyme Immunoassays (EIAs): Murex Anti-HCV EIA version 4.0; Fujirebio Innotest HCV Ab IV
~Line Immunoassay (LIA): MP Diagnostics HCV blot 3.0"
15851153|NCT04033874|Other|kangaroo care|kangaroo care
15851154|NCT04033874|Other|holding on the mother's lap|holding on the mother's lap
15851155|NCT04033874|Other|white noise listening|white noise listening
15851156|NCT04033874|Other|ambient sound listening|ambient sound listening
15851157|NCT04033861|Drug|rhBNP|rhBNP intra-coronary injection 1.5 ug/kg loading dose, with intravenous injection 0.0075-0.01 ug/kg/min persistent for 72 hour.
15851158|NCT04033861|Drug|Control|saline intra-coronary injection 0.15ml/kg loading dose, with same intravenous injection speed for 72 hour.
15851159|NCT04033848|Procedure|Arthroscopic assisted ankle fracture treatment|Any complex ankle fracture, as discriped above, will be treated arthroscopically and will be prospectively followed-up using well validated PROMs
15851160|NCT04033835|Other|Mentalization Based Treatment-Introductory|Mentalization Based Treatment-Introductory
15851161|NCT04033835|Other|Treatment as usual|Treatment as usual
15851162|NCT04033822|Procedure|cholecystectomy|If patients are randomized to the intervention arm of the study; said patient will undergo corrective cholecystectomy surgery to correct cholecystitis as soon as possible with a goal of surgery within 6 hours of diagnosis.
15851163|NCT04033809|Dietary Supplement|Multigrain powder (S)|A twice daily high fiber multigrain powder supplementation for 12 weeks
15851164|NCT04033796|Dietary Supplement|25,000 IU|Vitamin-D3 supplementation providing 25,000 IU administered orally every two months (equivalent to ~400 IU/d);
15851165|NCT04033796|Dietary Supplement|50,000 IU|Vitamin-D3 supplementation providing 50,000 IU administered orally every two months (equivalent to ~800 IU/d);
15851166|NCT04033796|Dietary Supplement|Placebo|A placebo (administered orally every two months) supplementation control group.
15851167|NCT04033783|Other|6MWT - accompanied|Assessor walks behind the patient
15851168|NCT04033783|Other|6MWT - not accompanied|Assessor does not walk behind the patient
15851169|NCT04033770|Other|Urodynamic investigation|Urodynamic investigation using an air-charged measurement system
15851170|NCT04033770|Other|Urodynamic investigation|Urodynamic investigation using a water-perfused measurement system
15851171|NCT04033744|Procedure|extraction of mandibular third molar|After loco-regional anesthesia was administered, a full-thickness mucoperiosteal flap was raised. The flap incision was extended from the vestibular side of the retromolar trigon to the second molar, corresponding to its distolingual cusp. The incision continued intrasulcular at the second molar and proceeded with a release incision distally to the papilla between the first and second molars, on a 45° angle. An osteotomy using a Lindemann burr under constant irrigation, followed by an odontotomy using a diamond burr was performed, if necessary
15851172|NCT04033731|Behavioral|Attention Network Task|The Attention Network Test (ANT) is a computerized cognitive task designed to efficiently probe three independent but interactive attentional networks (alerting, orienting, executive control) in a single task paradigm.
15851173|NCT04033718|Diagnostic Test|Inpatient testing package|The investigators will provide patients a package of diagnostic tests at the time of admission to comprehensively assess for HIV coinfections and treatment failure
15851174|NCT04033705|Device|Freestyle Libre Pro glucose sensor|Participants will wear a Freestyle Libre Pro glucose sensor for approximately 2 weeks prior to elective surgery and then for 2 weeks following surgery.
15851175|NCT04033692|Device|JuggerKnot Mini Soft Anchor|Patient who have been implanted with one or more JuggerKnot Mini Soft Anchor(s) who have undergone repair, repositioning or reattachment of soft tissues, ligament and tendons to the mandible is require for surgical stabilization of the TMJ articular disc.
15851176|NCT04033679|Other|Active TDCS|Participants will receive active TDCS stimulation.
15851177|NCT04033679|Other|Sham TDCS|Participants will receive sham TDCS stimulation.
15851178|NCT04033666|Other|High Flow Nasal cannula|The HFNC will be instituted therapy with high-flow nasal cannula with dosage and cannula calculated according to the child's weight, ranging from 2 l / min to 30 l / min. The therapy will begin with diaphragmatic exercises 3x10 breaths and after high-flow therapy with nasal cannula for 45 minutes, after which will be performed the vital signs evaluations and Peak Flow, HRV, FEV1.
15851179|NCT04033666|Other|NIV Noninvasive Ventilation|The Therapy consisted of 3x10 diaphragmatic re-education exercises after a Bipap device was coupled in bipedal mode with parameters Ipap 12 cm H2O and Epap 8 cm H2O, for 45 minutes, according to the patient's tolerance, with Full face facial mask. After therapy evaluated vital signs and measures of Peak Flow, HRV, FEV1.
15851180|NCT04033640|Diagnostic Test|STANDARD G6PD Test|The STANDARD G6PD Analyzer is designed to measure the quantitative determination of total-hemoglobin concentration and G6PD enzymatic activity in fresh human whole blood specimen based on reflectometry assays. The test is intended to aid in the identification of people with G6PD deficiency. The test is currently not licensed for use in Brazil and is considered an investigational product. PATH has conducted some initial laboratory evaluations which suggest that the test aligns to performance specifications outlined in the target product profile. The test has CE mark and is registered for use in South Korea, India, and Thailand.
15851181|NCT04033627|Procedure|In Vitro T cells depletion using CliniMCAS system|Use the CliniMACS TCRα/β and CD45 Systems to deplete TCRα/β+ and CD45RA+ cells from the mobilized peripheral blood stem cells of a haploidentical donor in patients with leukemia.
15851183|NCT04033601|Behavioral|Non-pharmacological intervention|The non-pharmacological intervention will comprise sleep hygiene education, exercise training and relevant modules of cognitive behavioral therapy.
15851184|NCT04033588|Device|Freedom® Total Knee System|To evaluate the survivorship, safety and performance of the Freedom® Total Knee System in the treatment of subjects who in the surgeon's opinion require a primary total knee replacement due to severe knee joint pain and loss of mobility due to osteoarthritis, rheumatoid arthritis or post-traumatic arthritis.
15851185|NCT04033575|Drug|Colgate Total SF|1100 ppm F Colgate Total Clean Mint White Paste Toothpaste is a test treatment
15851186|NCT04033575|Drug|Colgate Cavity Protection toothpaste|0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment.
15851187|NCT04033562|Drug|Lidocaine patch|Lidocaine patch will be applied at time of Cesarean delivery for post-operative pain control.
15851188|NCT04033562|Device|Ambu ACTion pump, 0.125% bupivacaine at 8cc/hr|Infusion pump will be placed at time of Cesarean delivery for post-operative pain control.
15851189|NCT04033536|Radiation|Involved Target Stereotacic Spine Radiosurgery|Image guidance spine stereotactic radiosurgery/ablative radiotherapy 1600 cGy in single fraction to Involved Target using IMRT/VMAT/RapidArc
15851190|NCT04033536|Radiation|Elective Target Stereotacic Spine Radiosurgery|Image guidance spine stereotactic radiosurgery/ablative radiotherapy 1600 cGy in single fraction to Elective Target using IMRT/VMAT/RapidArc
15851191|NCT04033523|Behavioral|HIIT|The HF group performed HIIT (3-min intervals at 40% and 80%VO2peak) on a bicycle ergometer for 30 min/day, 3 days/week for 12 weeks
15851192|NCT04033510|Other|Standard of Care Interventions to convert patient from atrial fibrillation to normal rhythm|Direct current cardioversion, PVAI-atrial fibrillation ablation, Minimally Invasive Surgical Maze procedure, Medications
15851193|NCT04033497|Device|MRI|Magnetic Resonance Imaging will generate imaging of the brain to identify recurrence of tumor.
15851299|NCT04032678|Device|LIFEPAK 15, Physio-Control Inc., Redmond, WA, USA|Cardioversion with a biphasic truncated exponential waveform
15852465|NCT04023071|Drug|Cyclophosphamide|Lympho-conditioning agent
15851194|NCT04033484|Procedure|Negative Pressure Wound Therapy|The perineal wound was reconstructed with biologic mesh after ELAPE. The subcutaneous adipose layer was closed with 2/0 vicryl sutures, and a suction drain was left in the deep layer. The subcuticular layer and skin were closed with 3/0 vicryl mattress sutures and the negative pressure system applied at 80 mmHg
15851195|NCT04033471|Drug|midazolam|epidural needle in the L1-2 or L2-3 space , and using loss of resistance technique udder strict aseptic condition 10 ml of the prepared drug will be given
15851196|NCT04033458|Drug|JNJ-64140284|Participants will receive JNJ-64140284 orally.
15851199|NCT04033432|Biological|Recombinant EphB4-HSA Fusion Protein|Given IV
15851200|NCT04033419|Drug|Memantine|"Week 1: 5 mg dose once daily
~Week 2: 5 mg dose twice daily
~Week 3: 5 mg each morning/10 mg each evening
~Week 4 through end of Chemotherapy: 10 mg dose twice daily
~Total duration: 12 - 26 weeks (depending on chemotherapy regimen)"
15851201|NCT04033406|Drug|VIR-2482|VIR-2482 given by intramuscular injection
15851202|NCT04033406|Drug|Placebo|Sterile normal saline (0.9% NaCl) given by intramuscular injection
15851203|NCT04033393|Other|Game based dual-task training|Participants in the experimental group will receive game based dual-task training with a treadmill
15851204|NCT04033393|Other|Treadmill training|Participants in the control group will receive treadmill training
15851205|NCT04033380|Device|Resin blocs (Grandio Blocs, VOCO)|composite-base bloc (Grandio Blocs, VOCO)
15851206|NCT04033380|Device|Ceramic (Suprinity, VITA)|glass ceramic zirconia enhanced lithium silicate glass ceramics (Suprinity, VITA)
15851207|NCT04033367|Drug|DUPILUMAB|Pharmaceutical form:solution for injection Route of administration: subcutaneous
15851208|NCT04033367|Drug|PLACEBO|Pharmaceutical form: solution for injection Route of administration: subcutaneous
15851209|NCT04033354|Drug|HLX10|HLX10 is an innovative monoclonal antibody targeting PD-1，developed by Shanghai Henlius Biotech, Inc.
15851210|NCT04033354|Drug|carboplatin and nab paclitaxel|chemotherapeutics
15851211|NCT04033354|Drug|Placebo|Placebo
15851212|NCT04033341|Drug|LY3214996|Administered orally
15851213|NCT04033341|Drug|[14C]-LY3214996|Administered orally
15851214|NCT04033328|Drug|ORIC-101|ORIC-101 once daily in each 28-day cycle
15851215|NCT04033328|Drug|enzalutamide 40 MG oral capsule [Xtandi]|160 mg once daily in each 28-day cycle
15851216|NCT04033302|Biological|CD7-specific CAR gene-engineered T cells|Infusion of CD7-specific CAR-T cells
15851217|NCT04033289|Device|Hip protection orthosis|Experimental group would wear hip protection orthosis over 12 hours a day for 1 year.
15851218|NCT04033276|Drug|Rituximab|IV rituximab
15851219|NCT04033276|Drug|intravenous immune globulin|iv intravenous immune globulin
15851220|NCT04033263|Other|Mouth rinse 1|Participants will use 10mL of the respective mouth rinse, swish in the mouth for 30 seconds and spit it out. This will be made twice a day, for a total of 5 days.
15851221|NCT04033263|Other|Mouth rinse 2|Participants will use 10mL of the respective mouth rinse, swish in the mouth for 30 seconds and spit it out. This will be made twice a day, for a total of 5 days.
15851222|NCT04033263|Other|Mouth rinse 3|Participants will use 10mL of the respective mouth rinse, swish in the mouth for 30 seconds and spit it out. This will be made twice a day, for a total of 5 days.
15851223|NCT04033263|Other|Mouth rinse 4|Participants will use 10mL of the respective mouth rinse, swish in the mouth for 30 seconds and spit it out. This will be made twice a day, for a total of 5 days.
15851224|NCT04033263|Other|Mouth rinse 5|Participants will use 10mL of the respective mouth rinse, swish in the mouth for 30 seconds and spit it out. This will be made twice a day, for a total of 5 days.
15851225|NCT04033263|Other|Mouth rinse 6|Participants will use 10mL of the respective mouth rinse, swish in the mouth for 30 seconds and spit it out. This will be made twice a day, for a total of 5 days.
15851226|NCT04033263|Other|Mouth rinse 7|Participants will use 10mL of the respective mouth rinse, swish in the mouth for 30 seconds and spit it out. This will be made twice a day, for a total of 5 days.
15851227|NCT04033263|Other|Mouth rinse 8|Participants will use 10mL of the respective mouth rinse, swish in the mouth for 30 seconds and spit it out. This will be made twice a day, for a total of 5 days.
15851228|NCT04033263|Other|Mouth rinse 9|Participants will use 10mL of the respective mouth rinse, swish in the mouth for 30 seconds and spit it out. This will be made twice a day, for a total of 5 days.
15851229|NCT04033250|Drug|Sodium Picosulfate / Magnesium Oxide / Citric Acid in two split doses + one dose of polyethylene glycol + two Bisacodyl tablets day before the procedure|Bowel preparation
15851230|NCT04033237|Other|Very low nicotine content cigarettes|Cigarettes containing 0.4 mg nicotine/g tobacco
15851231|NCT04033224|Device|Commercial membrane for Extracorporeal Blood Purification Therapy (EBPT)|Every center will prescribe EBPT with commercial membranes in accordance with local practice and local levels of expertise. No variation in treatment prescription and/or treatment solutions will derive from participation in this prospective observational study. Nonetheless, every setting parameter will be recorded in the web-based registry and analyzed a-posteriori to reveal a potential correlation with the patient outcomes.
15851232|NCT04033211|Device|Novosyn® CHD for fascia and skin closure|Experimental
15851233|NCT04033211|Device|Novosyn® for fascia and skin closure|Comparator
15851234|NCT04033198|Procedure|Appendectomy|patients diagnosed as acute appendicitis , appendectomy done
15851235|NCT04033185|Other|virtual reality, robot assisted gait training|study group: 15 sessions virtual reality, robot assisted gait training
15851236|NCT04033185|Other|conventional treatment|study group: 15 sessions conventional treatment control group: 30 sessions conventional treatment
15851237|NCT04033172|Drug|Pyrotinib Plus Fulvestrant|Pyrotinib: 400 mg/d, q.d., p.o. A course of treatment need 28 days. Fulvestrant: 500 mg/m2 q.d. i.m. A course of treatment need 28 day. First course needs extra dose of fulvestrant 500 mg/m2 q.d. i.m. on day 15.
15851238|NCT04033159|Drug|DYN101|DYN101, is a constrained ethyl gapmer ASO directed against human DNM2 RNA
15851264|NCT04032938|Procedure|extracorporeal circulation during cardiac surgery|We will observe the cardiopulmonary bypass status and time of patients undergoing cardiac surgery and extracorporeal circulation due to their medical needs.
15851239|NCT04033146|Device|Strengthening muscle contractions during walking|The investigators will use ankle-exoskeletons to systematically alter the behavior of participant muscle contractions. For example, participants will walk in a robotic device that adds a spring in parallel with their lower limb that will help the participants generate a stronger propulsive push-off and may reduce the effort of walking.
15851240|NCT04033133|Device|tDCS|Subjects will get tDCS at intensities of 0, 1, 2, 3, and 4 mA.
15851241|NCT04033107|Drug|Vitamin C|Participants will receive intravenous Vitamin C injection (dose: 1.5g/kg, D1-3, every 2 weeks), treatment termination when the disease progress is confirmed.
15851242|NCT04033107|Drug|Metformin|Participants will orally take metformin 4g daily.
15851243|NCT04033094|Drug|MorphaBond ER|This was a retrospective, non-interventional study. Previous users of branded and generic products (tablets or capsules) with ER and immediate release (IR) release type formulations of oxycodone, oxymorphone, hydromorphone and morphine (except MorphaBond).
15851244|NCT04033094|Drug|Comparator Drug|This was a retrospective, non-interventional study. Previous users of the MorphaBond ER brand of ER morphine sulfate with A-D labeling, by prescription or non-prescription.
15851245|NCT04033081|Device|CivaSheet|Implanting CivaSheet radiation therapy device at the time of surgery to irradiate surgical margin potentially preventing local recurrence
15851246|NCT04033068|Biological|Two MV-ZIKA-RSP vaccinations (high dose)|"In this arm of the study, 14 participants will receive:
~V1= day 0; dose vaccination with MV-ZIKA-RSP (high dose).
~V2= day 28; dose vaccination with MV-ZIKA-RSP (high dose).
~Description:
~Visit 1: Participants will receive their first vaccination with MV-ZIKA-RSP (high dose) Visit 2: Participants will receive their second vaccination with MV-ZIKA-RSP (high dose)"
15851247|NCT04033068|Biological|Two MV-ZIKA-RSP vaccination (low dose)|"In this arm of the study, 14 participants will receive:
~V1= day 0; dose vaccination with MV-ZIKA-RSP (low dose).
~V2= day 28; dose vaccination with MV-ZIKA-RSP (low dose).
~Description:
~Visit 1: Participants will receive their first vaccination with MV-ZIKA-RSP (low dose) Visit 2: Participants will receive their second vaccination with MV-ZIKA-RSP (low dose)"
15851248|NCT04033068|Biological|One MV-ZIKA-RSP vaccination (high dose) and one placebo|"In this arm of the study, 12 participants will receive:
~V1= day 0; dose vaccination with MV-ZIKA-RSP (high dose).
~V2= day 28; treatment with placebo
~Description:
~Visit 1: Participants will receive their first vaccination with MV-ZIKA-RSP (high dose) Visit 2: Participants will receive their second treatment with placebo"
15851249|NCT04033068|Other|Two placebo injection|"In this arm of the study, 8 participants will receive:
~V1= day 0; placebo treatment
~V2= day 28; placebo treatment
~Description:
~Visit 1: Participants will receive their first treatment with placebo Visit 2: Participants will receive their second treatment with placebo"
15851250|NCT04033055|Procedure|Inguinal hernia repair with CycloMesh™ soaked in ropivacaine hydrochloride 10mg/mL|"The surgical technique for the inguinal hernia repair is the surgeon's usual technique: open surgery (Lichtenstein technique).
~CycloMesh™ device (soaked in ropivacaine hydrochloride 10mg/mL) is positioned once the surgery for the inguinal hernia repair has been performed."
15851251|NCT04033055|Procedure|Inguinal hernia repair with CycloMesh™ soaked in saline solution NaCl 9°/°°|"The surgical technique for the inguinal hernia repair is the surgeon's usual technique: open surgery (Lichtenstein technique).
~CycloMesh™ device (soaked in saline solution) is positioned once the surgery for the inguinal hernia repair has been performed."
15851252|NCT04033042|Device|Prototype 0.5|Subjects will perform daily measurements on the IMD (Prototype 0.5) for 41 days.
15851253|NCT04033029|Device|Continuous venovenous hemodiafiltration with high adsorption membrane (oXiris®)|CRRT initiation will be determined by the treating physician on charge, according with the current recommendations of clinical practice and prescriptions of CRRT and local management protocols. The CVVHDF mode will be performed by using PrismafleX eXeed™ system and high adsorbent polyethyleneimide membrane (oXiris®). Filtration parameters will be determined following the local protocol (dose of 25-30 ml/kg/h).
15851254|NCT04033029|Drug|Antibiotics|Antibiotic concentration-time data will be collected and analyzed.
15851255|NCT04033016|Behavioral|motivational interviewing|Motivational interviewing (MI) is a contemporary form of advisory support, which is often used for behavioral change. During the motivational interviewing educated health professional leads the counseling session by asking questions on lifestyle, attitude towards the behavioral change, and factors pro and against the change. During the MI the focus is on the patient/ client, his/her own perception of their health, understanding the reasons for current behavioral patterns, and encouragement to assess these patterns.
15851256|NCT04033016|Behavioral|online social media intervention|Facebook group was specially designed for purposes of intervention and was administered by the research team. It was used to motivate the participants to be more physically active. The intervention used hybrid approach, with health promotion campaign with motivational messages and pictures, journal articles, questions with the aim to spark a discussion on barriers or possibilities for physical activity and participatory approach (all members were allowed to post motivational messages or questions for their peers).
15851257|NCT04033003|Behavioral|Group ANC|Intervention groups of up to 14 women of similar gestation age (10 to 20 weeks) for nine meetings. The first meeting is an individual meeting with the midwife and the standard history and physical exam as well as lab tests are completed. Group meetings are held once a month until 28 weeks of pregnancy, then every 2 weeks until 34 weeks of pregnancy, and the remaining group meetings are once a week. Prior to the start of each group, blood pressure, weight, and a urinalysis are measured for each woman.
15851258|NCT04032990|Device|Biostim-5 transcutaneous spinal stimulator|Safety and feasibility will be monitored during transcutaneous spinal stimulation in children with spinal cord injury
15851259|NCT04032977|Device|PN40082|To provide a 1-point improvement in the lip fullness grading scale score of subjects with very thin or thin lips or subjects with Fitzpatrick IV, V or VI to improve the LFGS score by 1 for 1 or both lips
15851260|NCT04032977|Device|Restylane Silk|To provide a 1-point improvement in the lip fullness grading scale score of subjects with very thin or thin lips or subjects with Fitzpatrick IV, V or VI to improve the LFGS score by 1 for 1 or both lips
15851261|NCT04032964|Drug|L19TNF|L19TNF 13 µg/kg i.v. will be administered on day 1, 3 and 5 of each 21-day cycle
15851262|NCT04032964|Drug|DOXORUBICIN|Doxorubicin 75 mg/m2 will be administered on day 1 of each 21-day cycle
15851263|NCT04032951|Other|Fine Needle Tissue Acquisition|diagnostic
15851297|NCT04032691|Drug|Clonidine Pill|0.1 mg by mouth daily at bedtime for one week
15851265|NCT04032925|Device|PICSO|"PICSO therapy is delivered through the PICSO Impulse System, which consists of the PICSO Impulse console and PICSO impulse catheter. The PICSO therapy is delivered in each patient for a minimum of 20 minutes to a maximum of 45 minutes.
~The PICSO Impulse catheter is automatically activated by the PICSO Impulse console. It is inserted in the coronary sinus via femoral vein access. The PICSO Impulse Console cyclically inflates and deflates the balloon at the tip of the PICSO Impulse catheter, generating transient increase in coronary sinus pressure."
15851266|NCT04032912|Diagnostic Test|iScan|this instrument provides extra confidence for in vivo diagnosis through improved vessel and mucosal pattern characterization.
15851267|NCT04032899|Dietary Supplement|Lactobacillus fermentum CECT5716|Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits.
15851268|NCT04032899|Dietary Supplement|Maltodextrin|Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits.
15851269|NCT04032886|Other|kinesio tape|This is a taping method used for correction of rounded shoulders.
15851270|NCT04032886|Other|exercise|Exercises include basic postural exercises.
15851271|NCT04032873|Other|Monetary Cost of Immobilization Treatments|Information regarding the monetary cost of casting and splinting patient's buckle fracture to be presented to adult subject/payer.
15851272|NCT04032873|Other|Physician|The monetary cost information is relayed by the patient's physician
15851273|NCT04032873|Other|Study Team|The monetary cost information is relayed by a member of the study team
15851274|NCT04032873|Other|Before Initial Treatment Decision|Monetary cost information is relayed during the initial consult, before the treatment decision is made.
15851275|NCT04032873|Other|After Initial Treatment Decision|Monetary cost information is relayed after the initial consult with the treating physician, after the treatment decision is made.
15851276|NCT04032860|Drug|Tenofovir Disoproxil|patients with HBV-HCC would take TDF as antiviral therapy before curative treatment to see the prognosis after surgery
15851277|NCT04032860|Drug|Entecavir|patients with HBV-HCC would take ETV as antiviral therapy before curative treatment to see the prognosis after surgery
15851278|NCT04032847|Biological|ATL001|ATL001 infusion
15851279|NCT04032847|Drug|Pembrolizumab|Checkpoint inhibitor
15851280|NCT04032834|Combination Product|VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with mouthpiece|The VR647 Inhalation System consists of the AKITA JET control unit that has an inspiration flow rate of 12 L/min, an AKITA JET nebulizer handset, a mouthpiece and dose-specific VR647 Smart Cards designed specifically for this trial.
15851281|NCT04032834|Combination Product|VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System (AKITA JET) with facemask|The VR647 Inhalation System consists of the AKITA JET control unit that has an inspiration flow rate of 12 L/min, an AKITA JET nebulizer handset, a facemask and dose-specific VR647 Smart Cards designed specifically for this trial.
15851282|NCT04032834|Combination Product|1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece|Commercial Pulmicort Respules (budesonide inhalation suspension 1 mg/2 mL) will be delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece operated to sputtering.
15851283|NCT04032834|Combination Product|1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemask|Commercial Pulmicort Respules (budesonide inhalation suspension 1 mg/2 mL) will be delivered by a conventional jet nebulizer (PARI VIOS) with facemask operated to sputtering.
15851284|NCT04032834|Combination Product|0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece|Commercial Pulmicort Respules (budesonide inhalation suspension 0.5 mg/2 mL) will be delivered by a conventional jet nebulizer (PARI VIOS) with mouthpiece operated to sputtering.
15851285|NCT04032834|Combination Product|0.5 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer (PARI VIOS) with facemask|Commercial Pulmicort Respules (budesonide inhalation suspension 0.5 mg/2 mL) will be delivered by a conventional jet nebulizer (PARI VIOS) with facemask operated to sputtering.
15851286|NCT04032821|Drug|Alkotinib（300mg)|1. First empty stomach, after the meal.2. After eating first, after fasting.
15851287|NCT04032795|Dietary Supplement|Lycium barbarum polysaccharide|Experimental group takes Lycium barbarum polysaccharide (LBP) tablet (300mg/day)for 6 weeks
15851288|NCT04032795|Dietary Supplement|Placebo|Placebo-controlled group take he placebo capsules that are identical in shape, color, and taste to LBP tablet.
15851289|NCT04032782|Drug|HM15136|10 mg/mL as protein in prefilled syringes
15851290|NCT04032782|Drug|Placebo of HM15136|Placebo in prefilled syringes
15851291|NCT04032769|Other|MODS (MOdified Diagnostic Strategy)|"Modified diagnostic strategy (MODS):
~All included patients will be tested with quantitative D-dimer. The MODS work-up strategy will be based on YEARS rule, that included three criteria (hemoptysis, signs of DVT, PE is the most likely diagnosis)
~- If all YEARS criteria are absent, the threshold of D-Dimer for ordering a CTPA will be raised at 1000 ng/ml.
~If at least one criterion of YEARS is present, then the D-dimer threshold for ordering a CTPA will be as usual (500 ng/ml, or agex10 for patients aged 50 and over)"
15851293|NCT04032730|Device|Wisepill device|"Participants will receive a Wisepill device for TB and ART medications. Participants will receive an exit counselling session prior to being discharged.
~Participants will select the content of a text message to be sent when missing a dose as measured by Wisepill non-opening during medication dose-window.
~Participants will receive a post-discharge phone call by study staff for the purpose of identifying any early challenges or obstacles. All participants may receive a titrated Wisepill intervention (TWI) consisting of a text message, phone call, and/or study home visit triggered by medication non-adherence as detected by Wisepill non-opening.
~All participants will receive a monthly counselling intervention (MCI). Adherence support groups (ASG) will be conducted on a monthly basis."
15851294|NCT04032717|Drug|Q-Griffithsin (Q-GRFT) enema|Investigational enema composed of 4.2mL Q-Griffithsin (Q-GRFT) 9.6mg/mL combined with approximately 120.8mL of 0.9% sodium chloride solution to yield an active enema study product that will contain and deliver a dose of approximately 40mg of Q-GRFT
15851295|NCT04032717|Other|Placebo enema|Approximately 125mL of 0.9% sodium chloride solution
15851296|NCT04032704|Drug|ladiratuzumab vedotin|Intravenous (into the vein; IV) infusion
15956247|NCT03216343|Drug|Chiauranib|CS2164
15851300|NCT04032665|Diagnostic Test|Rivaroxaban|In stable CAD/PAD patients with previous PCI and DES-implantation treated with DAPT (ASA+clopidogrel) platelet rich plasma (PRP) and washed platelets as well as serum/plasma/urinary samples will be collected between 2 and 4 weeks before switching from DAPT to ASA + rivaroxaban (2,5 mg b.i.d.), between 2 and 4 weeks under monotherapy with ASA 100mg o.d., and between 2 and 4 weeks under therapy with ASA 100mg o.d. + rivaroxaban (2,5 mg b.i.d.) and treated ex vivo with rivaroxaban to asses platelet activation and function, platelet-triggered thrombin generation and platelet-dependent vascular inflammation.
15851301|NCT04032652|Procedure|Rectal dialysis|Rectal dialysis done after 1 week on either 1200/2400 mg Asacol dose to test rectal mucosal 5-ASA levels
15851302|NCT04032652|Drug|Rectal dialysis|Rectal dialysis done after 1 week on either 1200/2400 mg Asacol dose to test rectal mucosal 5-ASA levels
15851303|NCT04032626|Drug|Lenalidomide 10 mg|Lenalid
15851304|NCT04032626|Drug|Placebo|Placebo
15851305|NCT04032613|Other|Vascular Access Navigation and Education Quality Improvement Program|A Vascular Access Navigation and Education Quality Improvement Program implemented in the Geisinger Danville, PA chronic kidney disease clinic. Participants complete questionnaires to assess their vascular access care knowledge and confidence before and after the implementation of the quality improvement program.
15851306|NCT04032600|Procedure|Paracentesis|Full versus partial paracentesis (3 liters)
15851307|NCT04032587|Behavioral|Modified training version of the Approach / Avoidance Task (AAT, see Wiers et al., 2011)|First, a modified training version of the Approach Avoidance Task, (see Wiers et al. 2011) with arbitrary Pavlovian cues will be developed and the effectiveness of this manipulation will be assessed. In detail, positive as well as negative Pavlovian cues (derived from a Pavlovian-to-Instrumental transfer Task, see Garbusow et al. 2014, Garbusow et al. 2016) will be modified according to their approach/ avoidance propensities by 1) approaching negative stimuli (pulling joystick), 2) approaching positive stimuli (pulling joystick), 3) avoiding negative stimuli (pushing joystick) and 4) avoiding positive stimuli (pushing joystick). Thus, we aim at reversing the PIT effect (pushing positive cues/ pulling negative cues) or enhancing the PIT effect (pulling positive cues/ pushing negative cues).
15851308|NCT04032587|Behavioral|Mindfulness-based interventions (e.g. body scan)|Acute stress reduction will be applied in a standardized way using audio files with an anticipated duration of 20-30 minutes.
15851309|NCT04032574|Combination Product|Herbal Medicinal Product|
15851310|NCT04032574|Other|Placebo|
15851311|NCT04032548|Drug|Placebo mouthwash|After using mouthwash for 21 days, they are instructed to refrain from mouthwash for 14 days (wash out period).
15851312|NCT04032548|Drug|Propolis mouthwash|After using mouthwash for 21 days, they are instructed to refrain from mouthwash for 14 days (wash out period).
15851313|NCT04032548|Drug|Chlorhexidine mouthwash|After using mouthwash for 21 days, they are instructed to refrain from mouthwash for 14 days (wash out period).
15851314|NCT04032535|Drug|CHF6523|CHF6523 is a PI3K inhibitor (phosphoinositide3-kinase)
15851315|NCT04032522|Other|point-of care (PoC) neonatal HIV early infant diagnosis (EID)|clinical impact of a PoC-EID for infants and neonates at birth and week 4-8 weeks, linked with nurse-supported immediate ART initiation in HIV-infected neonates, versus standard-of-care (SoC)
15851316|NCT04032509|Other|2 x 5 mL blood sample|2 x 5 mL blood sample to determine the performance of the automated VIDAS BTI platform in assessing serum concentrations of GFAP and UCH-L1 to rule out the need for a CT-scan after mTBI.
15851317|NCT04032496|Behavioral|Contemplative-Based Intervention for People Living with SLE|Intervention sessions will follow a 6-week format consisting of weekly in-person sessions as well as guided homework to encourage practice at home. Some mindfulness practices that will be included are meditation, group exercise (yoga), group discussions, and deep breathing. Both participants diagnosed with SLE as well as caregivers will participate in the intervention sessions. 5 sessions will be approximately 2 hours long, while the final session will be approximately 4 hours long. Each intervention group will include approximately 4 participants with SLE and 4 caregivers.
15851318|NCT04032496|Behavioral|Health Enhancement Program (HEP)|The HEP was designed to create an active control for mindfulness-based stress reduction (MBSR) interventions. The structure of this intervention will mirror that of the other arm of this study, but will lack the mindfulness component. The HEP includes topics such as physical activity, functional movement, music therapy, and nutrition education.
15851319|NCT04032470|Device|Deep Brain Stimulation Systems (DBS)|Subjects receiving DBS implant for treatment of Essential Tremor
15851320|NCT04032457|Device|Phase A - olifilcon B with Tangible Coatings|Daily disposable silicone hydrogel contact lens
15851321|NCT04032457|Device|Phase B - etafilcon A with Tangible Coatings|Daily disposable hydrogel contact lens
15851322|NCT04032431|Behavioral|Telerehab VR intervention|Training with VR system using software specifically designed to reproduce activities of daily living
15851323|NCT04032418|Biological|Pembrolizumab|Given IV
15851324|NCT04032405|Procedure|CAF+CTG+i-prf|combined connective tissue graft (CTG) and injectable platelet rich fibrin (i-prf) with coronally advanced flap (CAF)
15851325|NCT04032392|Biological|autologous γδT cells|Cells will be extracted by apheresis, followed by expanding and activating. The autologous γδT cells product will be adoptive transferred.
15851326|NCT04032379|Other|Standard treatment|No intervention, some patients have additional neuro-psychological testing.
15851327|NCT04032366|Drug|inhaled nitric oxide|using of inhaled nitric oxide
15851328|NCT04032366|Device|PEEP|increasing PEEP or decreasing PEEP
15851329|NCT04032353|Other|Medical Consortium|subjects received intensive follow-up by coordinators according to the predifined protocol of MCSC
15851330|NCT04032340|Other|dog presence|This project seeks to assess positive impacts of companion dog presence in elderly living at home ; to assess loneliness and isolement between eldlery with a companion dog and without, at home
15851331|NCT04032327|Drug|Exparel plus plain bupivacaine|10 mL of extended release liposomal bupivacaine (Exparel) plus 10 mL of 0.25% plain bupivacaine mixed to be injected vaginally prior to the start of posterior colporrhaphy
15851332|NCT04032327|Drug|Bupivacaine|20 mL of 0.25% plain bupivacaine to be injected vaginally prior to the start of posterior colporrhaphy
15851333|NCT04032301|Drug|Ketamine|Six infusions of intravenous 0.5 mg/kg ketamine hydrochloride solution over 3 weeks.
15851334|NCT04032301|Other|Normal Saline|Six infusions of intravenous normal saline solution over 3 weeks.
15965362|NCT03147677|Drug|Irbesartan|
15851335|NCT04032275|Other|Chronic hepatitis B infection|Chronic hepatitis B infection patients
15851336|NCT04032262|Diagnostic Test|Gastrointestinal and Parkinson's Disease|Subjects with Parkinson's disease will come for visits that will contain questionnaires about their PD, their bowel movements, and do further tests using anal rectal probes to understand further their constipation, and other tests to gather data on their digestion.
15851337|NCT04032249|Behavioral|Control Group (CG)|The control group is subjected to follow a hypocaloric diet and receives information about the benefits of having healthy habits in relation to decision making and food
15851338|NCT04032249|Behavioral|Intervention Group (IG)|The control group is subjected to follow a hypocaloric diet and receives information about the benefits of having healthy habits in relation to decision making and food, but also, they will have monitored the self-control of the weight in order to compare the impact of self-weighing versus not doing it
15851339|NCT04032236|Other|caffeine|At room temperature (18-25 ° C) the same place and standard environment will be done. All involved cases will undergo a dental examination and within 30 minutes three samples of saliva will be taken, including first sample, after coffee drink and after drinking water. The pH of samples will be measured and the smoking cessation rate of the smoking cigarette smoker with simultaneous VAS (VISUAL ANALOG SCALA) will be measured. This data will be compared in-house and non-smoking control group
15851340|NCT04032223|Procedure|Implant placemet in the mandibular canine regions|Implant placemet in the mandibular canine regions retained by cast metal copings or 3D printed metal copings to deliver Implant Supported telescopic overdenture in the mandible
15851341|NCT04032210|Other|dual Zinc plus Arginine based toothpaste (Colgate total)|Regimen using dual Zinc plus Arginine based toothpaste (Colgate total)
15851342|NCT04032210|Other|Zinc based toothpaste (Crest complete)|Regimen using Zinc based toothpaste (Crest complete)
15851343|NCT04032210|Other|Fluoride based toothpaste (Signal)|Fluoride based toothpaste (Signal)
15851344|NCT04032197|Drug|Semaglutide|Subcutaneous (s.c., under the skin) injections for 52 weeks. Participants will remain on their pre-study standard of care treatment (antidiabetic medication and CV medication).
15851345|NCT04032197|Drug|Placebo (semaglutide)|Subcutaneous (s.c., under the skin) injections for 52 weeks. Participants will remain on their pre-study standard of care treatment (antidiabetic medication and CV medication).
15851346|NCT04032184|Other|Fluoride toothpaste|regimen using fluoride toothpaste
15851347|NCT04032184|Other|fluoride toothpaste and chlorhexidine mouthwash|regimen using fluoride toothpaste and chlorhexidine mouthwash
15851348|NCT04032184|Other|fluoride toothpaste, chlorhexidine mouthwash, MI varnish|regimen using fluoride toothpaste, chlorhexidine mouthwash, MI varnish
15851349|NCT04032171|Drug|Evobrutinib|Participants received evobrutinib twice daily (BID).
15851350|NCT04032171|Drug|Avonex®|Participants received avonex® IM injection once a week.
15851351|NCT04032171|Drug|Avonex® matched Placebo|Participants received IM injection of placebo matched to avonex® once a week.
15851352|NCT04032171|Drug|Evobrutinib matched Placebo|Participants received placebo matched to evobrutinib twice a day.
15851353|NCT04032158|Drug|Evobrutinib|Participants received evobrutinib twice daily (BID).
15851354|NCT04032158|Drug|Avonex®|Participants received avonex® IM injection once a week.
15851355|NCT04032158|Drug|Avonex® matched Placebo|Participants received IM injection of placebo matched to Avonex® once a week.
15851356|NCT04032158|Drug|Evobrutinib matched Placebo|Participants received placebo matched to evobrutinib twice a day.
15851357|NCT04032132|Drug|curcumin paste|curcumin is a herb used for medical purpose
15851358|NCT04032132|Procedure|curettage|open flab debridement surgery
15851359|NCT04032119|Procedure|Endoscopic submucosal dissection|Endoscopic submucosal dissection
15851360|NCT04032119|Drug|Epinephrine|Epinephrine
15851361|NCT04032106|Other|Best Practice|Receive standard information about HPV and HPV vaccine
15851362|NCT04032106|Other|Informational Intervention|Receive Outsmart HPV intervention
15851363|NCT04032106|Other|Questionnaire Administration|Ancillary studies
15851364|NCT04032106|Behavioral|Text Message-Based Intervention|Receive unidirectional text message vaccine reminders
15851365|NCT04032106|Behavioral|Text Message-Based Intervention|Receive interactive text message vaccine reminders
15851366|NCT04032093|Biological|RSV vaccine|RSV vaccine
15851367|NCT04032093|Biological|Placebo|Normal saline solution for injection (0.9% sodium chloride injection)
15851368|NCT04032080|Combination Product|Drug 1: LY3023414; Drug 2: Prexasertib|"Metastatic TNBC patients will consent to and undergo core needle biopsies of a metastatic lesion for NGS, RPPA, and other molecular analyses at study entry.
~Patients will then be treated with 150 mg LY3023414 PO BID and prexasertib 80 mg/m^2 IV administered every 2 weeks until disease progression or unacceptable toxicity. Any time after the completion of Cycle 2 of the treatment combination, or at the physician's discretion, a second core needle biopsy of the same metastatic lesion (or different metastases if the initial metastasis has regressed) will be performed for RPPA and other molecular analyses. If a research biopsy from a patient's metastatic disease cannot be safely obtained, a skin biopsy is permitted.
~Treatment will be discontinued in patients who achieve a confirmed clinical complete response, and these patients will be followed to document the durability of the complete responses."
15851369|NCT04032067|Drug|GV1001 placebo|0.9 % Normal Saline
15851370|NCT04032067|Drug|Proscar placebo|PO
15851371|NCT04032054|Device|mono-axial and poly-axial screws|types of pedicular screws for thoracolumbar fractures fixation
15851372|NCT04032041|Device|Structure Sensor|A 3D representation of each participant's lower limb geometry will be obtained using a Structure Core scanner (Occipital, Inc.) which uses an infrared structured light projector to construct a 3D image of an object. The scanner is connected to an iPad; to operate the user rotates the iPad camera around the desired object. In seconds, the entire geometry is digitally reconstructed.
15851373|NCT04032015|Device|TMS|Device used to administer electromagnetic fields to the brain to alter connectivity patterns
15851374|NCT04032002|Other|Explorations|On Day 1 vascular fonctions explorations performed
15851375|NCT04032002|Other|Blood samples|On Day 1 35ml taken
15851376|NCT04031950|Device|Novel wearable paediatric device|The patient will wear the novel wearable paediatric device at the same time as polysmnography
15852133|NCT04025697|Other|Rapid prototyped denture|A 3d printed complete denture will be constructed
15851377|NCT04031937|Other|Psychomotor assessment|the intervention include a depression scale, an anxiety scale, a sensory profile scale, a body image questionnaire, a self-esteem questionnaire, a psychomotor retardation scale and a standardized assessment of : muscle tone (dangling and extensibility); gross motor skills (walks, jump, static balance, dynamic balance); manual performance; manual praxis; adaptation of rhythm; manual gnosis; executive function
15851378|NCT04031924|Other|Assessment of: 1. Functional Capacity 2. Physical Fitness 3. Physical Activity Level 4. Balance 5. Kinesiophobia 6. Psychological Status 7. Fatigue Severity|All liver transplantation patients who underwent transplant at least one year ago and healthy subjects were evaluated the first day they came.
15851379|NCT04031911|Device|Hydroposturotherapy|"Hydroposturotherapy combines:
~posturotherapy (patient placed upside down with water jets sent to the kidneys)
~lumbar percussion
~hyperdiuresis: prescribed quantities of water to be absorbed by the patient"
15851380|NCT04031911|Device|Standard support in urology|Dispensing of AFU plugs Dietary advice
15851381|NCT04031898|Other|Non Interventional|This is a non interventional, observational, retrospective study including patients with EGFR-mutated advanced NSCLC, treated with 1st or 2nd generation EGFR TKI therapy in first line
15851382|NCT04031885|Drug|Abemaciclib|Administered orally
15851383|NCT04031885|Drug|Fulvestrant|Administered IM
15851384|NCT04031885|Drug|Standard Chemotherapy|Standard chemotherapy of physician's choice administered according to product label.
15851385|NCT04031872|Drug|LY3200882|Combination treatment with LY3200882 and capecitabine
15851386|NCT04031859|Drug|acetylsalicylic acid|It's a VTE risk stratification tool or procedure that will be used after total knee replacement (TKR) to help surgeons in choosing the tailored VTE prophylaxis according to patients' specific VTE risk, this tool will stratify the TKR-patient in one of three risk-groups: Low high risk who will be prescribed Aspirin upon hospital discharge as extended VTE prophylaxis post TKR surgery, or moderate high risk group who will be prescribed oral anti coagulant (like rivaroxaban) as extended prophylaxis, and the last group is very high risk group who will be prescribed parenteral anticoagulant ( like Enoxaparin) plus compression devices.
15851387|NCT04031846|Drug|Rotarix™|Single 1.5 mL oral dose at 2 and 4 months of age (Study Day 1 and Month 2)
15851388|NCT04031846|Drug|Infanrix™ hexa|Single 0.5 mL intramuscular injection at 2, 3, 4, and 11-15 months of age (Study Day 1, Month 1, Month 2, and Month 9-13)
15851389|NCT04031846|Drug|V114|15-valent pneumococcal conjugate vaccine (PCV) containing 13 serotypes present in Prevenar 13™ (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL intramuscular administration,
15851390|NCT04031846|Drug|Prevenar 13™|13-valent PCV containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL intramuscular administration.
15851391|NCT04031833|Drug|MAT2203|Encochleated amphotericin B
15851392|NCT04031833|Drug|Amphotericin B|Intravenous amphotericin B
15851393|NCT04031820|Procedure|Unipolar cup|Cemented unipolar acetabulum cup for primary THA
15851394|NCT04031820|Procedure|Dual mobility cup|Cemented dual mobility acetabulum cup for primary THA
15851396|NCT04031794|Device|Extra Corporeal Membrane Oxygenator (ECMO)|Two cannular will be inserted via femoral vein or internal jugular vein and connect with blood pump and membrane oxygenation.
15851397|NCT04031781|Device|repetitive transcranial magnetic stimulation (rTMS) 100% motor threshold|Each rTMS session consisted of a single train of 900 total pulses over 3 minutes duration.
15851398|NCT04031781|Device|repetitive transcranial magnetic stimulation (rTMS) 50% motor threshold|Each rTMS session consisted of a single train of 900 total pulses over 3 minutes duration.
15851399|NCT04031768|Other|Timing of rest prior to blood pressure measurement|Each participant will have 4 sets of 3 blood pressure measurements taken. The participants will be randomized to the order in which they rest prior to each set of measurements.
15851400|NCT04031755|Drug|Minocycline|Minocycline 100 mg capsules or matching placebo will be prepared by the central investigational pharmacy at Cincinnati Children's Hospital Medical Center. Drug identity will be masked by over encapsulation of the study drug.
15851401|NCT04031755|Drug|Placebos|Minocycline 100 mg capsules or matching placebo will be prepared by the central investigational pharmacy at Cincinnati Children's Hospital Medical Center. Drug identity will be masked by over encapsulation of the study drug.
15851402|NCT04031742|Biological|IBI306|Administered by subcutaneous injection
15851403|NCT04031742|Biological|IBI306|Administered by subcutaneous injection
15851404|NCT04031729|Drug|Aspirin 81 mg|Aspirin 81mg tablets will be given once daily, for the duration of the clinical trial.
15851405|NCT04031729|Drug|Placebo oral tablet|Identical, blinded placebo tablets will be given once daily, for the duration of the clinical trial.
15851407|NCT04031703|Drug|Paclitaxel|Paclitaxel chemotherapy (injection)
15851408|NCT04031703|Drug|Carboplatin|Carboplatin chemotherapy (injection)
15851409|NCT04031703|Drug|Epirubicin|Epirubicin chemotherapy (injection)
15851410|NCT04031703|Drug|Cyclophosphamide|Cyclophosphamide chemotherapy (injection)
15851411|NCT04031703|Drug|5-fluorouracil|5-fluorouracil chemotherapy (injection)
15851412|NCT04031703|Drug|Docetaxel|Docetaxel chemotherapy (injection)
15851413|NCT04031690|Other|Caregiver Quality of Life Questionnaires|Measurement of quality of life at D0, M6 and M12 via SF-36, CarGOQoL and the one-dimensional Zarit score
15851414|NCT04031690|Other|Patient Quality of Life Questionnaires|Quality of life measurement at D0, M6 and M12 via the SF-36
15851415|NCT04031677|Procedure|Surgery|Large en-bloc curative-intent surgery
15852466|NCT04023071|Drug|Fludarabine|Lympho-conditioning agent
15851416|NCT04031677|Drug|Preoperative chemotherapy|"- High grade LPS: ADM 75 mg/m2 (or the equivalent EpiADM 120 mg/m2) + ifosfamide 9 g/m2 Q3 weeks
~Note: the recommended dose of Ifosfamide can be modified according to national/institutional guidelines, given that the minimum threshold must be 7.5 g/m2 per cycle.
~- LMS: ADM 75 mg/m2 + DTIC 1g/m2 Q3 weeks"
15851417|NCT04031664|Drug|Qianjin Capsule of Gynaecology|To evaluate the short-term and long-term efficacy of traditional Chinese medicine of Qianjin Capsule of Gynaecology in reducing the use of antibiotics, reducing the risk of clinical use of drugs.
15851418|NCT04031651|Drug|Pudilan Xiaoyan Oral Liquid|In the respiratory and emergency departments of the hospitals under surveillance, the medication of Pudilan Xiaoyan Oral Liquid is observed for those aged 18-80 years who strictly follow the prescription of the instructions.
15851419|NCT04031638|Other|Radioactive Iodine treatment|Patients with a thyroid tumor who received radioactive Iodine treatment.
15851420|NCT04031625|Other|Metastatic Colorectal Cancer Database|Metastatic Colorectal Cancer Database
15851421|NCT04031612|Drug|Neoadjuvant therapy|Neoadjuvant therapy
15851422|NCT04031599|Device|Single-hormone closed-loop system|Every 10 minutes, the glucose levels as measured by the sensor will be transferred automatically to a LG Google Nexus Smartphone that the algorithm is running on, which will calculate the recommended doses and will send them wirelessly to the infusion pump.
15851423|NCT04031599|Device|Insulin pump|Tandem Diabetes Care
15851424|NCT04031599|Device|Continuous glucose monitoring system|Dexcom G5 Platinum
15851425|NCT04031599|Drug|Aspart or Lispro|Aspart or lispro will be infused with the infusion pump
15851426|NCT04031599|Other|Carbohydrate counting|Participants will be required to enter an estimate of the carbohydrate content of their meal into the phone. Insulin boluses will be calculated based on grams of carbohydrates and participant's insulin-to-carbohydrate ratio. Carbohydrate-matching full prandial bolus will be given 5 to 10 minutes before the meal.
15851427|NCT04031599|Other|Simplified qualitative meal-size estimation strategy|A pre-meal partial prandial bolus will be given 5-10 minutes before the meal. The partial bolus will be based on the estimated meal size (small, regular, large and extra-large). The closed-loop system will give the remaining insulin needed based on the sensor readings. For this strategy, meal size will be defined as: small as any meal less than 30g, regular meal as any meal between 30g and 60g CHO, large meal as any meal between 60g and 90g CHO, extra-large meal for anything above 90g CHO.
15851428|NCT04031599|Other|3-week intervention|Glucose levels will be regulated by the single-hormone closed-loop system for 3 consecutive weeks.
15851429|NCT04031573|Drug|Ivabradine|Ivabradine will be administered via the enteral route, every 12 hours, at doses ranging from 2.5 to 5 mg to achieve a target heart rate between 80 and 94 bpm
15851430|NCT04031573|Drug|Ivabradine|Ivabradine will be administered via the enteral route, every 12 hours, at doses ranging from 5 to 7.5 mg to achieve a target heart rate between 80 and 94
15851431|NCT04031573|Drug|Placebo|Placebo will be administered via the enteral route, every 12 hours.
15851432|NCT04031560|Behavioral|Integrative treatment|The experimental group (62 patients) will take part on the integrative group program consisting of 12-sessions, 90 minutes each, once a week (4 focused on psychoeducation, 1 directed to the family relatives, 3 on mindfulness and 4 on functional remediation)
15851433|NCT04031547|Device|Transcranial Electrical Stimulation (tES)|In tES, a mild electrical current is passed between two or more electrodes placed on the scalp.
15851434|NCT04031534|Drug|F-Miso PET scan coupled with MRI|Patient will undergo F-Miso PET and MRI before surgery for their head and neck cancer. Hypoxia detect with imaging will be correlated with hypoxia detected by immunohistochemistry on tumour biopsy
15851435|NCT04031521|Diagnostic Test|Near infrared spectroscopy|NIRS is an emerging technology for measuring tissue oxygenation and endothelial function. NIRS light can penetrate through biological tissues, including skin, bone, and muscle. Similar to other optical methods, light is applied to the region of interest and undergoes scattering and absorption before being detected by a photosensor. This technique is commonly used to assess oxygen availability and consumption in living tissues. Using different wavelengths, NIRS can differentiate between oxygenated and deoxygenated hemoglobin in blood and can measure changes in total hemoglobin concentration, using the sum of oxygenated and deoxygenated hemoglobin.
15851436|NCT04031508|Combination Product|lipid injectable emulsion with Fish oil|TPN will start at 2.0 g/kg/d of the lipid emulsion, increasing 1.0 g/kg/d until a maximum of 4.0 g/kg/d for at least 14 days.
15851437|NCT04031495|Device|central vein cannulation|central vein cannulation
15851438|NCT04031482|Other|No intervention, only standard care|"The aim of this registry is to expand on previous findings in the field of diagnostic and therapeutic pathways for patients with Crohn's disease, ulcerative colitis and indeterminate colitis undergoing routine administration of a targeted therapy (biologics or another targeted therapy such as Janus kinase therapy) and various different treatment approaches. A data pool is to be generated for this purpose, in order to
~analyse disease progression
~systematize findings about treatment processes
~identify potential influencing factors
~review any new diagnostic procedures
~identify potential test subjects for further study
~evaluate the safety of various treatment concepts"
15851439|NCT04031469|Other|There is no intervention in this study|There is no intervention in this study
15851440|NCT04031456|Biological|Autologous Platelet Rich Plasma|Autologous PRP intra ovarian infusion
15851441|NCT04031456|Biological|Placebo-Platelet Free Plasma|Autologous PFP intra ovarian infusion
15851442|NCT04031430|Device|Telemonitoring|Women who are allocated to the PSM groep, will receive a connected blood pressure monitor. They have to measure their blood pressure twice a day and fill in their weight once a week in the App. These data are automatically transmitted via Bluetooth and Wi-Fi to the hospital, but the caregiver will not see those data, and can not react to it.
15851443|NCT04031417|Other|Hypoxia|
15851444|NCT04031417|Other|Low Humidity|
15851445|NCT04031404|Device|Single-pulse TMS|Single-pulse transcranial magnetic stimulation (TMS) on the motor cortex will lead to a twitch in the target muscle and evoke a motor-evoked potential (MEP) measured by electromyography (EMG).
15851476|NCT04031079|Device|Wearable tech without feedback|an armwrist device measuring physical activity level, no reporting back to the user
15851477|NCT04031079|Behavioral|Rehabilitation program|traditional inpatient rehabilitation program for overweight and obesity (lifestyle change program)
15851478|NCT04031066|Drug|Velmanase Alfa|infusion i.v. treatment
15851446|NCT04031391|Other|Physical activity|"The intervention group: engaged in a therapeutic physical activity program involving low-intensity exercise, strength and balance work for 2 days a week over a 12-week period, with each session lasting 90 minutes. Both the intervention group and the control group separately completed the various baseline surveys which were part of the study. Once the intervention was over, they answered them again, also separately.
~The classes were led by an experienced physiotherapist who followed the physical exercise guidelines established by the American College of Sports Medicine (ACSM), although the intensity of the exercises was adapted to the participants' tolerance levels"
15851447|NCT04031378|Radiation|Single Dose Radiotherapy (24 Gy) to all detectable lesions, followed by observation|SBRT to a single dose of 24 Gy to up to 3 sites
15851448|NCT04031378|Drug|Single Dose Radiotherapy (24 Gy) to all detectable lesions followed by adjuvant systemic therapy for 6 months|SBRT 24 Gy to up to 3 nsites, followed by by systemic therapy based on phenotype.
15851449|NCT04031365|Procedure|Acupuncture|Use of sterile, disposable needles in acupuncture
15851450|NCT04031365|Behavioral|Cognitive Behavioral Therapy|psychotherapy
15851451|NCT04031352|Other|implementation of CATCH scale|subject completed the CATCH scale
15851452|NCT04031339|Procedure|Standard treatment|e.g., surgery, radioiodine therapy, systemic treatments (multikinase inhibitors), surveillance
15851453|NCT04031326|Behavioral|LENA Home|LENA Home is a 13-week curriculum designed to add an early-language focus to existing home visiting or parent education programs for children ages birth to three. It employs LENA wearable audio recorder technology and targeted content to help parents and other caregivers increase interactive talk. There are 13 weekly one-on-one sessions, including modules on parent-child reading and increasing verbal interaction during typical home activities. Sessions include videos, practical techniques, and feedback from LENA recordings via intuitive reports to help parents talk more with their children. LENA Home reports provide data on adult words spoken to the child (AWC) and conversational turns (CTC). LENA Home has been shown to increase interactive talk and child language ability and informs parents how much they are talking with their children in an objective way.
15851454|NCT04031300|Device|Prototype 0.5|Investigational Medical Device collecting spectral Raman data non-invasively from tissue
15851455|NCT04031274|Device|TAVI|Trascatheter aortic valve implantation
15851456|NCT04031274|Device|TMVR/r|Transcatheter mitral valve replacement/repair
15851457|NCT04031248|Device|Whole body vibration|In this study an axial vibratory platform will be used: POWER-PLATE pro 5 AIRdaptive TM HP®. This device is reviewed annually by the technical unit of the company itself and complies with the international regulations that regulate the Medical Devices [Devices Directive (MDD) 93/42 / EEC (ISO 2631. 2011, Powerplate.com, 2013)]. The vibration will be administered with 2 mm of amplitude and 40 Hz of frequency.
15851458|NCT04031248|Other|EXERCISE group|The program will consist of a routine of 18 exercises that will be executed where the greatest neuromuscular recruitment is sought. Most exercises are dynamic and isotonic. It is structured following the scheduled phases (ACSM, 2013) of warm-up, development and return to calm or stretching. The total duration of the program is 22 minutes, keeping the general lines of high-intensity aerobic interval training, which establishes a rest period at least equal to that of work. The treatment protocol will consist of 11 sessions applied in 4 weeks under an intervention regime of weeks 3 sessions, with a duration per session of 22 minutes, which will be supervised by a physiotherapist with more than 15 years of clinical experience.
15851459|NCT04031235|Behavioral|Sleep Baby, Safe and Snug|Specially designed children's book, 14 pages, rhyming, illustrated in color, written at a Kindergarten reading level. Each page spread highlights AAP-recommended safe sleep practices. AAP safe sleep recommendations listed on the back cover.
15851460|NCT04031235|Behavioral|Read Baby, Every Day|Specially designed children's book, 14 pages, rhyming, illustrated in color, written at a Kindergarten reading level. Each page spread highlights AAP-recommendations regarding the importance of reading and talking to infants. Recommendations and benefits of reading with infants are listed on the back cover as well.
15851461|NCT04031209|Device|G7 Acetabular System|All patients will receive G7 Acetabular System
15851462|NCT04031196|Procedure|QLB|QLB type 2 approach
15851463|NCT04031196|Procedure|TAP block|classic TAP block approach
15851464|NCT04031170|Behavioral|Incredible Years® School Age Basic Parent Training Program|The Incredible Years® School Age Basic Parent Training Program targets many of the proposed mechanisms and risk factors for internalizing distress in early childhood: harsh and unpredictable or critical parenting behaviors. Parents also learn cognitive strategies for themselves; such as self-praise, coping thoughts, how to challenge negative thoughts, and how to get support that they are encouraged to model for and teach their children. Finally, they learn how to be more positive and nurturing through academic, social and emotional coaching.
15851465|NCT04031170|Other|American Academy of Pediatrics, Bright Futures Handouts|Written materials that include age-group specific tips on how parents can support their child's development and social and academic success.
15851466|NCT04031157|Device|Predictix Antidepressant|Predictix Antidepressant guided treatment
15851467|NCT04031144|Procedure|Ultrafiltration|At the end of CPB procedure, free water is partly removed by ultrafiltration to increase relative mass of red blood cell and plasma components.
15851468|NCT04031131|Drug|Instillagel|Topical Anaesthetic Gel (Instillagel) licensed for rectal administration.
15851469|NCT04031131|Other|KY Gel|Lubricant Gel
15851470|NCT04031118|Device|Apioc Contact Lens|Measurement of corneal oxygen uptake with contact lens wear.
15851471|NCT04031105|Device|Theta-burst stimulation (TBS)|"intermittent (iTBS) and continuous (cTBS) will be applied at an intensity of 70% or 100%* resting motor threshold (RMT) on the dorsolateral prefrontal cortex, position F3 (EEG 10-20 international system)
~*The optimal %RMT will be evaluated in a pilot study before commencement of the main study"
15851472|NCT04031092|Device|Wearable tech with feedback|An armwrist device measuring physical activity level. The user will receive information about their physical activity level through their smartphone.
15851473|NCT04031092|Device|Wearable tech without feedback|An armwrist device measuring physical activity level, no reporting back to the user.
15851474|NCT04031092|Behavioral|Rehabilitation program|traditional inpatient rehabilitation program.
15851475|NCT04031079|Device|Wearable tech with feedback|an armwrist device measuring physical activity level. The user will receive information about their physical activity level through their smartphone
15981128|NCT03028441|Other|Placebo|Placebo
15851480|NCT04031053|Other|Pharmacokinetic study|The blood will be collected at pre-dose and at 1, 3, 4, 5, 6, 8 and 12-hour post dose
15851481|NCT04031040|Device|Genio(TM) system therapy|Hypoglossal nerve stimulation system
15851482|NCT04031027|Drug|Apremilast|Apremilast is prescribed in accordance with the terms of the SmPC and the marketing authorizations.
15851483|NCT04031014|Device|BTL EMSELLA Active treatment|BTL EMSELLA delivers high intensity focused electromagnetic technology to induce pelvic floor muscle contractions up to maximum intensity of 100% for active treatment
15851484|NCT04031014|Device|BTL EMSELLA Sham Treatment|BTL EMSELLA delivers high intensity focused electromagnetic technology to induce pelvic floor muscle contractions up to maximum intensity of 5% for sham treatment
15851485|NCT04031001|Device|No-React Non-valved Conduit|Operative replacement of infected graft or implantation in infected area.
15851486|NCT04030988|Drug|Oral dexamethasone minipulse|50 patients will receive mini pulse dexamethasone therapy in a dose of 3 mg/ day for adults or 1.5 mg/day for children on two consecutive days per week plus NB-UVB phototherapy at starting dose of 0.3 J/cm2, at a rate of 3 times per week for 6 months (72 sessions) with gradually increasing increments.
15851487|NCT04030988|Drug|Placebo oral tablet|50 patients will receive placebo having the same color, form and packaging as the dexamethasone therapy for 6 months plus NB-UVB phototherapy at starting dose of 0.3 J/cm2, at a rate of 3 times per week for 6 months (72 sessions) with gradually increasing increments
15851488|NCT04030962|Drug|AGN-242428|Ophthalmic solution administered as a topical eye drop
15851489|NCT04030962|Drug|AGN-231868|Ophthalmic solution administered as a topical eye drop
15851490|NCT04030962|Other|AGN-242428 Vehicle|Matching placebo (vehicle) ophthalmic solution administered as a topical eye drop
15851491|NCT04030962|Other|AGN-231868 Vehicle|Matching placebo (vehicle) ophthalmic solution administered as a topical eye drop
15851492|NCT04030962|Drug|Comparator ophthalmic solution|Ophthalmic solution administered as a topical eye drop
15851493|NCT04030949|Other|No new interventions will be applied. MLST and MLVA even vPCR are tests already existing, tested and without any known adverse effects for the participants|No new interventions will be applied. MLST and MLVA even vPCR are tests already existing, tested and without any known adverse effects for the participants
15851494|NCT04030923|Device|repetitive transcranial magnetic stimulation|By defining intensity of 80% of the resting Motor Threshold detected from motor area for Rt Abductor Pollicis Brevis (APB), we will apply repetitive Transcranial Magnetic Stimulation (rTMS) using 70-mm diameter air-cooled figure-of-8 coil and SuperRapid2 Magnetic Stimulator with high frequency (25Hz), Stimuli will be delivered for total 2000 pulse (divided on 50 trains with 40 pulses per train with inter-train interval 30 seconds) for the left DLPFC (coil placed tangential over the optimal position of 7 cm anterior to hand motor hotspot area detected for Real group and the same coil placed perpendicular with hand of coil pointing upward over occipital cortex for Sham group). Sessions will be consecutive for ten days period with repetition of consecutive 5 sessions as boosting doses on 5 days period over the follow up visits every month for the next 3 months.
15851495|NCT04030910|Other|'LIFEView'|A prototype audiovisual technology in development by Motitech AS.
15851496|NCT04030897|Behavioral|Parent-Directed Online Single-Session Program|Online, 15-minute self-administered program for parents
15851497|NCT04030897|Behavioral|Youth-Directed Online Single-Session Program|Online, 30 minute self-administered program for youths
15851498|NCT04030897|Behavioral|Information/Psychoeducation/Referral|Usual care at pediatric primary care clinics participating in this study
15851499|NCT04030884|Dietary Supplement|Honey and water mixture|"60 gr of organic Turkish BlackSea Region Chestnut Honey and 100 ml Spring water mixture both mixed in room temperature and ingested up to two hours before the surgery by participants who were nill by mouth from midnight prior to the operation day."
15851500|NCT04030871|Device|Capsule Dome G-Tube|Feeding replacement tubes with two different FDA approved devices in forty subjects
15851501|NCT04030871|Device|Balloon Bolus feeding tube|Feeding replacement tubes with two different FDA approved devices in forty subjects
15851502|NCT04030858|Behavioral|Plant-based diet + nutrition education|The intervention group will adopt a nutrient-dense dietary pattern and receive nutrition education sessions specific to that lifestyle. The diet protocol is comprised of minimally-processed plant foods such as fruits, vegetables, legumes, beans, nuts and seeds. No refined sugars, added salt, or oil will be included. Dietary fat intake limited to 20% of total calories or less per day. Animal products will be eliminated. This dietary pattern is expected to improve resilience, mood, inflammation, microbiome, spirituality, and overall general health (as measured by weight, cholesterol, blood pressure). The treatment group will also receive weekly nutrition education sessions to support the diet.
15851503|NCT04030845|Procedure|breast reconstruction|The breast reconstruction mainly included autologous tissue flaps (latissimus dorsi myocutaneous flaps, pedicled tansverse rectus abdominis myocutaneous flaps, free transverse rectus abdominis musculocutaneous flaps, deep inferior epigastric artery perforator flaps, etc.), implant based breast reconstruction, autologous flaps combined with implant reconstruction, fat graft, etc.
15851504|NCT04030845|Procedure|oncoplastic breast-conserving surgery|The oncoplastic breast-conserving surgery were mainly those surgeries using volume displacement or volume replacement techniques.
15851505|NCT04030819|Behavioral|schema therapy|The intervention is the schema therapy focuses on the management of anxiety and is based on self-efficacy, self-management . It consists of 20 once-weekly sessions of 90 minutes (with a 15 Min break), with homework activities between the sessions
15851506|NCT04030806|Other|Mirror therapy intervention and control intervention|"The exercise protocol will be composed of bimanual activities, performed by both the hands of the patient (paretic and healthy). The same protocol will be applied for both groups (intervention group and control group).
~Initially, the desensitization of the limbs will be accomplished by brushing the skin with objects of different textures (sponge, brush, cloths). Afterwards, isolated exercises of fingers (flexion-extension, opposition), wrists (flexo-extension), forearms (prono-supination) and elbows (flexo-extension) and functional exercises such as cleaning a table with a cloth, tightening sponges, roll balls. Each exercise will be performed slowly and repeated for 15 times, totaling three series of each exercise. The protocol used will be based on the proposal of Rothgangel and Braun (2013). The intervention will be carried out by the author of the project and by students of scientific initiation."
15852467|NCT04023071|Drug|IL-2|Biologic response modifier
15986373|NCT02990403|Drug|Prednisone|
15851507|NCT04030793|Device|Individualized transcranial direct current stimulation|Based on tDCS stimulation, individualized stimulation during 30 minutes with sitting position.
15851508|NCT04030793|Device|Conventional transcranial direct current stimulation|Conventional tDCS stimulation during 30 minutes with sitting position.
15851509|NCT04030780|Dietary Supplement|spore-forming probiotic|spore-forming probiotic administered as 1 capsule twice daily (2,5 x 109 CFU per capsule) during 8 weeks
15851510|NCT04030780|Other|Placebo|similar capsules administered twice daily
15851511|NCT04030767|Drug|Botox Injectable Product|Botulinum toxin produces partial chemical denervation of the muscle resulting in localized reduction in muscle activity
15851512|NCT04030754|Combination Product|amniotic membrane|amniotic membrane is a biological dressing
15851513|NCT04030754|Combination Product|duoderm dressing|duoderm dressing is a synthetic dressing
15851514|NCT04030741|Drug|Meronem and flagyl|meronem and flagy
15851515|NCT04030741|Procedure|Appendectomy|Appendectomy as treatment for acute appendicitis
15851516|NCT04030715|Drug|bismuth-containing quadral therapy based on antibiotic susceptibility|the different mucosal pathology graded by New Sydney System
15851517|NCT04030689|Other|data collected from patient file|socio-demographics, previous HIV testing history, history of HIV contamination, clinics HIV related data will be collected for each patient who notified his non-objection to participate to this non interventional study.
15851518|NCT04030676|Procedure|Biopsies|Two more biopsies in inflammatory zone will be collected.
15851519|NCT04030676|Biological|Blood samples|Blood samples will be performed necessary at QuantiFERON-CMV (QF-CMV) test.
15851520|NCT04030663|Drug|papaverine|periradial injection of one of three drugs prior to cannulation of radial artery by 20 minutes and mesure the diamter of it by ultrasound
15851521|NCT04030663|Drug|nitroglycerine|periradial injection of one of three drugs prior to cannulation of radial artery by 20 minutes and mesure the diamter of it by ultrasound
15851522|NCT04030663|Drug|xlyocaine|periradial injection of one of three drugs prior to cannulation of radial artery by 20 minutes and mesure the diamter of it by ultrasound
15851523|NCT04030650|Other|Functional analyses|2-minute walking test 200-metre walking test
15851524|NCT04030650|Other|3D analysis of walking and balance|Walking analysis Balance analysis Analysis of the strength of the flexor and extensor muscles of the trunk and lower limb
15851525|NCT04030650|Other|Functional analyses|400-metre walking test 200-metre walking test
15851526|NCT04030624|Device|Remote Electronic Patient Monitoring|The Remote Patient Monitoring intervention is a remote monitoring system intended for use by healthcare professionals for the collection of physiological data in home and healthcare settings. Patient information is displayed on a computer located at the medical institution. Throughout the day, patient data from the remote monitoring system are presented on the clinician user interface (e.g., temperature, blood pressure, heart rate, respiration rate). Data are transmitted from sensors to the patient's smart phone.
15851527|NCT04030611|Diagnostic Test|tongue diagnosis system|This study apply TCM diagnostic tools for clinical diseases, providing objective diagnostic data for evaluation to assess the association of blood stasis and DR.
15851528|NCT04030598|Drug|IONIS-PKK-LRx|IONIS-PKK-LRx administered SC
15851529|NCT04030598|Drug|Placebo|Placebo matching solution administered SC
15851530|NCT04030585|Device|Robot|Patients with upper limb amputation using myoelectric prosthesis will done robot-assisted exercise program
15851531|NCT04030585|Other|Home exercise|Patients with upper limb amputation using myoelectric prosthesis will done home exercise program
15851532|NCT04030572|Drug|Clonidine Pill|0.1 mg tabs, one by mouth daily at bedtime for one week
15851533|NCT04030559|Drug|Niraparib|Given PO
15851534|NCT04030559|Drug|Niraparib Tosylate Monohydrate|Given PO
15851535|NCT04030559|Procedure|Radical Prostatectomy|Undergo standard of care surgery
15851536|NCT04030546|Drug|Ivabradine|Ivabradine capsule
15851537|NCT04030533|Drug|Guselkumab (SC): Dose 1|Participants will receive a single dose of guselkumab (dose 1) subcutaneously.
15851538|NCT04030533|Drug|Guselkumab (SC): Dose 2|Participants will receive a single dose of guselkumab (dose 2) subcutaneously.
15851539|NCT04030533|Drug|Guselkumab (IV): Dose 1|Participants will receive a single IV infusion of guselkumab (dose 1).
15851540|NCT04030533|Drug|Guselkumab (IV): Dose 2|Participants will receive a single IV infusion of guselkumab (dose 2).
15851541|NCT04030533|Drug|Ustekinumab 6 mg/mL|Participants will receive a single IV infusion of ustekinumab 6 mg/mL solution.
15851542|NCT04030520|Behavioral|POPPi behavioral intervention|behavioral intervention with offer of HIV self test
15851543|NCT04030520|Behavioral|POPPi behavioral intervention|behavioral intervention
15851544|NCT04030507|Device|MRI|MRI (which stands for magnetic resonance imaging) provide imaging of the brain which help look for brain metastases (spread of the breast cancer to the brain).
15851545|NCT04030494|Diagnostic Test|BP measurement|sequential BP measurement with Withings WPM04 and sphygmomanometer with dual observer auscultation
15851546|NCT04030494|Diagnostic Test|AF detection|single lead ECG with Withings WPM04 and 12 lead ECG
15851547|NCT04030494|Diagnostic Test|VHD detection|phonocardiogram with digital stethoscope of Withings WPM04 and Doppler echocardiography
15851548|NCT04030481|Other|inhalation anesthesia|sevoflurane was used to maintain anesthesia
15851549|NCT04030481|Other|Total intravenous anesthesia|propofol was used to maintain anesthesia
15851550|NCT04030468|Other|Educational intervention addressed to general practitioners|"feedback reports regarding the status of their patients according to the appropriateness indicators determined at baseline and the pooled prevalences for their patients, Local Health Units, and region
~Continuous Medical Education (CME) course"
15851551|NCT04030468|Other|Informative intervention addressed to patients|• leaflets and posters distributed in primary care ambulatories and community pharmacies, focusing on correct drug use
15851552|NCT04030455|Drug|Carboplatin|Given IV
15851553|NCT04030455|Drug|Cisplatin|Given IV
15851554|NCT04030455|Drug|Docetaxel|Given IV
15851555|NCT04030455|Biological|Pembrolizumab|Given IV
15851556|NCT04030442|Drug|Immediate-release Oral Morphine Sulfate Tablets|0 mg Immediate release oral morphine; 15 mg Immediate release oral morphine; 30 mg Immediate release oral morphine; Randomized between sessions
15851557|NCT04030442|Other|Thermal and Pressure Nociceptive Sensitivity|Primary outcome measures of pain threshold and tolerance.
15851558|NCT04030429|Drug|Crizotinib 250 MG|bid orally
15851559|NCT04030390|Behavioral|Physical Fatigue|Maximal cycling effort for 30s (Wingate modified)
15851560|NCT04030390|Behavioral|Control|time-matched task (sitting on the bike without pedalling)
15851561|NCT04030364|Behavioral|CrossFit group exercise classes|"The group classes will occur at a local CrossFit gym facility. Participants will be free to attend up to 6 regularly-scheduled, free, 1-hr group classes per week at the local exercise facility for a period of 3-months. The recommendation will be to aim to attend at least three classes/week but there will no prescribed minimum. Classes will be supervised by experienced trainers.
~Trainers will work collaboratively with participants to adapt the skill and workout of the day within each group class to the individual participant's physical limitations and needs. As such, each participant may complete a slightly different movement or workout on any given day based on their functional status at that time. However, all participants will be actively included in the community of the group class and will experience a relative stimulus that is moderately challenging for them."
15851562|NCT04030351|Other|food - dried fruit|raisins, apricots, figs, and pineapple
15851563|NCT04030338|Drug|18F-DCFPyL-iPSMA|Participants will be injected intravenously with a bolus of 7-10 mCi of 18F-DCFPyL.
15851564|NCT04030338|Drug|68Ga-HBED-iPSMA|Participants will be injected intravenously with a bolus of 3-8 mCi of 68Ga-HBED-iPSMA
15851565|NCT04030338|Diagnostic Test|PET/CT scan|The baseline PSMA PET scan may be performed externally or at MSKCC, but all follow-up imaging must be performed at MSKCC. Approximately 60-90 minutes after intravenous injection of radiotracer, patients will be scanned from the mid-skull to the mid-thigh. Imaging will start with a low-dose CT for attenuation correction, followed by a PET scan. Upon completion of imaging and at the discretion of the investigator, the patient may be asked to void and get back in the scanner for 1 additional image of the pelvis.This additional image allows investigator's to see an unobstructed view of the prostate/prostate bed
15851566|NCT04030325|Behavioral|Sequential Post Feedback Intervention Delivery|Sequential PFI delivery over 3 weeks after baseline survey
15851567|NCT04030325|Behavioral|Simultaneous Post Feedback Intervention Delivery|Simultaneous PFI delivery after baseline survey
15851568|NCT04030325|Behavioral|Text Message Boosters|Text message boosters on PFI content during week of high risk drinking events
15851569|NCT04030312|Dietary Supplement|Bottle Supplementation--Commercially-Sterilized Donor Human Milk|Supplementation by bottle with 20-calorie-per-ounce commercially-sterilized donor human milk (up to 15 ml, up to two times) for infants meeting hypoglycemia criteria and randomized to this treatment arm.
15851570|NCT04030312|Dietary Supplement|Bottle Supplementation--Standard Infant Formula|Supplementation by bottle with 20-calorie-per-ounce standard infant formula (up to 15 ml, up to two times) for infants meeting hypoglycemia criteria and randomized to this treatment arm.
15851571|NCT04030299|Device|Over-the-counter fitting|In this group, pre-configured hearing aids, which simulate over-the-counter hearing aids, will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids.
15851572|NCT04030286|Other|Observation|Evaluation of Malondialdehyde level and correlation of Malondialdehyde level with periodontal and cardiovascular disease
15851573|NCT04030273|Diagnostic Test|Diagnostic hysteroscopy|"Diagnostic hysteroscopy performed in outpatient setting, using no touch vaginoscopy technique with a 2.9 mm 30-degree rigid hysteroscope with a single inflow sheet using normal saline as distention media."
15851574|NCT04030260|Drug|Regorafenib and Nivolumab in Combination with Radiotherapy|Regorafenib will be given 3 weeks on/1 week off (80 mg od po.) and Nivolumab administered IV at a dose of 3mg/kg every 2 weeks with or without irinotecan administered IV at a fixed dose of 80-100mg every 2 weeks
15851575|NCT04030260|Radiation|Radiation therapy|Radiation therapy is believed to increase the likelihood of response of immunotherapy
15851576|NCT04030247|Drug|Plant Sterol|Patients will receive a plant sterol supplement to take twice daily from their cardiologist/dietician in management of their moderate risk of cardiovascular disease.
15851577|NCT04030234|Drug|Intensive BP treatment group|"Participants in the Intensive BP treatment group have a goal of SBP <120 mmHg. It is recommended to provide long-acting antihypertensive medications, that is once daily, unless other medication delivery frequency is needed. The local investigator may select among the available study antihypertensive medications. Other drugs not supplied by the trial may also be used as the investigator determines appropriate.
~One or more medications from the following classes of agents will be provided by the study for use in managing participants in both randomization groups to achieve study goals:
~Angiotension converting enzyme (ACE)-inhibitors; Angiotension receptor blockers (ARBs); Thiazide-type diuretics; Loop diuretics; Potassium-sparing diuretics; Beta-blockers; Calcium channel blockers (CCBs); Direct vasodilators; Alpha1-receptor blockers; Sympatholytics"
15851578|NCT04030234|Drug|Standard BP treatment group|Participants in the Standard BP treatment group have a goal of SBP <140 mmHg. The same medications used in the Intensive BP treatment group will be used for the Standard BP treatment group.
15851579|NCT04030221|Other|fluid infusion|250 ml of liquid will be given within 10 minutes for each patients, and the hemodynamic parameters before and after fluid infusion will be recorded. Then the experiment is completed.
15851580|NCT04030208|Device|Umbulizer|Umbulizer is a reliable, user-friendly, and portable system that provides consistent air to the patient by quantitatively delivering a pre-determined tidal volume, inhale/exhale (I/E) ratio, peak pressure, and breathing rate (BPM). It can be configured to deliver either controlled ventilation or assist-controlled ventilation.
15851581|NCT04030208|Device|Traditional Mechanical Ventilator|A medical device designed to artificially perform breathing functions for patients who are unable to adequately perform these functions on their own.
15851582|NCT04030195|Genetic|PBCAR20A|"Single dose of Allogeneic Anti-CD20 CAR T cells will be infused, and a classic 3+3 dose escalation will be applied."
15851583|NCT04030195|Drug|Fludarabine|Fludarabine is used for lymphodepletion.
15851584|NCT04030195|Drug|Cyclophosphamide|Cyclophosphamide is used for lymphodepletion.
15851585|NCT04030182|Diagnostic Test|Level of Vitamin D|3 ml of venous blood will be taken to determine the level of vitamin D
15851586|NCT04030169|Drug|MDMA|Non-directive psychotherapy conducted during MDMA-assisted psychotherapy session
15852468|NCT04023058|Procedure|Mitral surgery|Guidelines approved mitral surgery
15851587|NCT04030156|Procedure|tonsillectomy|Tonsillectomy was performed under general anesthesia using cold dissection method.
15851588|NCT04030143|Drug|Aripiprazole|Aripiprazole long acting injection.
15851589|NCT04030143|Drug|Aripiprazole|Aripiprazole depot injection
15851590|NCT04030130|Behavioral|NDURE|NDURE is a theory-based, multi-level Patient Navigation (PN) intervention consisting of three in-person, clinic-based sessions of manualized PN with multiple intervention components that target system- (care coordination), interpersonal- (social support), and individual- (Health Belief Model; perceived susceptibility, severity, barriers, self-efficacy) level health behavior theoretical constructs to reduce barriers to care, improve cancer care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months).
15851591|NCT04030117|Procedure|ACTIVA Bioactive restoration|Removal of Class II decay in second primary molars and placement of ACTIVA restoration.
15851592|NCT04030117|Procedure|Compomer restoration|Removal of Class II decay in second primary molars and placement of Compomer restoration.
15851593|NCT04030104|Device|Reader Study - Imagio Ultrasound|Imagio ultrasound images to be reviewed as part of Reader study
15851594|NCT04030104|Device|Reader Study Imagio Ultrasound + Optoacoustic Imaging|Imagio Ultrasound + Optoacoustic images to be reviewed as part of Reader study
15851595|NCT04030104|Device|Mammography|Mammography as available per standard of care
15851596|NCT04030091|Drug|3 hours humulin R 100 IU/mL PIT|PIT procedure: a venous catheter will be placed into one superficial vein at one arm, which will be connected to the insulin infusion pump and a glucose infusion pump via a three-way connector. Endothelial function will be measured by means of the Vendys 2 device. The blood glucose will be tested by means of a POCT meter and the CGM, and the PIT procedure will be started (10 pulses of 3 U of regular human insulin per hour). Blood glucose will be tested every 5 to 10 min and glucose infusion will be started once a drop in blood glucose is detected. Adjustment of glucose administration will be performed until a stable glucose value between 80 mg/dL to 160 mg/dL is reached. In parallel, endothelial function will be measured every 30 min. At the end of the PIT procedure, the venous catheter will be removed and the patient will be discharged until the next visit.
15851597|NCT04030091|Drug|2 hours humulin R 100 IU/mL PIT|"As described for the Intervention 3 hours of pulsatile insulin infusion (PIT) with humulin R 100 IU/mL, the treatment duration is just one hour less."
15851598|NCT04030078|Other|Survey|Questionnaire-based survey
15851599|NCT04030065|Drug|Omega 3 fatty acid|10% Omega-3 fatty acid oil will be supplemented in intravenous form from preoperative day 1, intra-operatively (anytime during surgery before reperfusion of graft) and from post operative day 1 to day 5 in the study group. The preparation used will be 100 ml injection which contains 10 gm of Omega 3 fatty acids.
15851600|NCT04030052|Drug|Nuwiq (low dose protocol)|After receiving HEMLIBRA® for 1-6 months, rFVIII (NUWIQ®) will be given at low dose (25 ±5 units/kg/dose) every 7-14 days as part of a low dose factor exposure program and for on demand use for acute bleeding episodes/procedures. NUWIQ® will be administered intravenously (IV) via peripheral infusion. If the infant has a central line such as a PICC line or mediport this can be used.
15851601|NCT04030052|Drug|HEMLIBRA|Four weekly subcutaneous (SQ) injections of HEMLIBRA® loading doses of 3 mg/kg will be given. A total of 12 mg/kg within the first month is allowed for the loading doses. Maintenance dosing will follow, and will either be 1.5 mg/kg/dose weekly, 3 mg/kg/dose biweekly (every 2 weeks), or 6 mg/kg/dose every 4 weeks depending on the recommended dosing.
15851602|NCT04030052|Drug|Nuwiq (Atlanta protocol)|After completing HEMLIBRA® loading doses, participants will receive intravenous (IV) infusions of NUWIQ® 3 times per week, 100 units/kg the Atlanta protocol. Infusions will be given at least 36 hours from the previous NUWIQ® injection. Participants will continue on the HEMLIBRA® SQ - NUWIQ® IV treatment regimen for up to 12 months of NUWIQ® treatment.
15851603|NCT04030039|Drug|Interferon|chronic hepatitis B patients with interferon therapy
15851604|NCT04030039|Drug|nucleoside analogues|chronic hepatitis B patients with interferon therapy
15851605|NCT04030026|Drug|Nalbuphine ER|Subjects on NAL ER will have the dose titrated from 27 mg once daily (QD) to 54 mg BID over a 5-day period and then maintained at 54 mg BID for approximately 4 days. Doses will be subsequently escalated and maintained at 108 mg BID over 1 week and then to 162 mg BID over 6 days.
15851606|NCT04030026|Drug|Placebo oral tablet|Placebo Comparative will be given in Arm 1b and again in Arm 2a
15851607|NCT04030013|Other|group education|All patients of group 1 and 2 will receive intensive education for 3-4 months, then refreshment session every 3 months for 2 years. Initially, patient data will be collected through 3 types of forms: patient identification form, metabolic control parameters form and diabetes self-care scale questionnaire; then every 6 months metabolic parameters and diabetes self-care scale questionnaire will be reassessed.
15851608|NCT04030000|Drug|Paclitaxel/Carboplatin|IV paclitaxel in combination with IP carboplatin
15851609|NCT04030000|Radiation|Pelvic radiation therapy|EBRT and vaginal brachytherapy
15851610|NCT04029987|Procedure|Bilateral Ultrasound-Guided Transmuscular Quadratus Lumborum Block.|A 22 G echogenic needle will be inserted in plane from the posterior (medial) end of the probe and directed for the fascial plane between the Quadratus Lumborum and the Psoa Major muscles through the Quadratus Lumborum muscle. Once the needle is confirmed in correct location, 1 mL of saline will be injected after negative aspiration. Then 0.5 mL/Kg of bupivacaine 0.25% will be injected. The spread of the injectate should be observed to distribute within this plane. This technique will be repeated to the other side.
15851611|NCT04029987|Procedure|Bilateral Ultrasound-Guided intra smuscular Quadratus Lumborum Block.|A 22 G echogenic needle will be inserted in plane from ventral (lateral) edge of the probe and advanced until penetration of QL muscle fascia is observed. Once the needle is confirmed in correct location, 1 mL of saline will be injected after negative aspiration. Then 0.5 mL/Kg of bupivacaine 0.25% will be injected. The spread of the injectate should be observed to distribute within this plane. This technique will be repeated to the other side.
15851612|NCT04029987|Procedure|Control|Conventional analgesia
15851613|NCT04029974|Device|ErigoPro|Robotic tilt-stepper lower extremity movements at the cadence of 0, 40, and 80 steps/minute.
15851614|NCT04029961|Other|Video Education|Prior to their CT simulation, participants will receive education on radiation therapy in the form of a video.
15851675|NCT04029532|Device|Heart rate variability|Ask participants to supine on bed for 10 minutes, connect electrodes on their right wrist. Measure heart rate variability for 5 minutes.
15851615|NCT04029961|Other|VR-based Education|Prior to their CT simulation, participants will receive education on radiation therapy in the form of an immersive VR program delivered through a head-mounted display (HMD).
15851616|NCT04029948|Procedure|Laser En Bloc Resection Of bladder Tumor|Using laser beam starting the procedure with circumferential incision few millimetres around the tumour then lifting the tumour and dissection underneath its muscle base
15851617|NCT04029948|Procedure|Electro-surgical En Bloc Resection Of bladder Tumor|Using electro-surgical loop starting the procedure with circumferential incision few millimetres around the tumour then lifting the tumour and dissection underneath its muscle base
15851618|NCT04029935|Behavioral|Physical Fatigue|Maximal cycling effort for 30s (Wingate modified)
15851619|NCT04029935|Behavioral|Control|time-matched task (sitting on the bike without pedalling)
15851620|NCT04029922|Drug|MT-5111 (experimental study drug)|Experimental treatment with MT-5111
15851621|NCT04029909|Drug|Gimatecan 0.6mg/m2/d|0.6mg/m2/d for once a day for 5 consecutive days of Gimatecan
15851622|NCT04029909|Drug|0.8mg/m2/d|0.8mg/m2/d for once a day for 5 consecutive days of Gimatecan
15851623|NCT04029909|Drug|0.4mg/m2/d|0.4mg/m2/d for once a day for 5 consecutive days of Gimatecan
15851624|NCT04029896|Biological|HB-adMSCs|intravenous infusion of Hope Biosciences autologous adipose-derived stem cells
15851625|NCT04029883|Behavioral|Text Message|A key insight from BE is that people typically are initially highly motivated to change their behavior, but their enthusiasm declines over time.103 To keep the importance of routinizing pill-taking salient (i.e. high on a person's mental priority list), we will send daily text messages using a freely available web platform.
15851626|NCT04029883|Behavioral|Behavior Economic Incentive|In this group, participants will be eligible for a prize drawing if they take their medication within +/- 1 hour of the time they carry out their existing routine behavior on at least 80% of days between clinic visits.
15851627|NCT04029883|Behavioral|Text Message|A key insight from BE is that people typically are initially highly motivated to change their behavior, but their enthusiasm declines over time.103 To keep the importance of routinizing pill-taking salient (i.e. high on a person's mental priority list), we will send daily text messages using a freely available web platform.
15851628|NCT04029857|Dietary Supplement|Nutritional Supplement Drink|Given standard of care nutritional supplementation
15851629|NCT04029857|Dietary Supplement|Nutritional Supplementation|Given Impact Advanced Recovery PO or via feeding tube
15851630|NCT04029844|Device|Colibri TAVI System|Implantation of Colibri heart valve
15851631|NCT04029831|Drug|Propofol and Ketamine Mixture (Ketofol)|Each group was given Ketofol, but group K61 received mixture of propofol and ketamine in a ratio of 6:1 while K41 received 4:1
15851632|NCT04029818|Biological|Bifidobacterium BSL_PS404|Each participant will consume 1 capsule daily at lunch for 8 weeks.
15851633|NCT04029818|Biological|Placebo|Each participant will consume 1 capsule daily at lunch for 8 weeks.
15851634|NCT04029805|Combination Product|Combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6|Each participant will consume 2 capsules daily, in the morning and at night without any restriction in the diet nor in their habits of life.
15851635|NCT04029805|Combination Product|Placebo|Each participant will consume 2 capsules daily, in the morning and at night without any restriction in the diet nor in their habits of life.
15851636|NCT04029792|Combination Product|Combination of plant extracts (BSL_EP028)|Each participant will consume 2 capsules daily, in the morning and at night without any restriction in the diet nor in their habits of life.
15851637|NCT04029792|Combination Product|Placebo|Each participant will consume 2 capsules daily, in the morning and at night without any restriction in the diet nor in their habits of life.
15851638|NCT04029779|Biological|I-PRF|Local anaesthesia was administered and mucoperiosteal flap was reflected. Atraumatic tooth extraction was performed. Socket was curetted to remove the granulation tissue present in the socket with the help of curettes. The socket was well irrigated with saline. Implant osteotomies wasl performed with sequential drilling with standardized drills.I-PRF was freshly prepared 600rpm for 7 min(50g). 1ml of the i-PRF was applied in to the osteotomy site and the implant surface will be thoroughly coated followed by placing of the implant. The surgical site was thoroughly irrigated and debrided. Flap closure was achieved using 3-0 silk sutures to protect the implant site.
15851639|NCT04029766|Drug|HSK3486|
15851640|NCT04029753|Behavioral|Walk out from operating room|After the surgery of laparoscopic radical gastrectomy, patients will be encouraged to walk out from the operating room and return to the ward by walking under the condition of stable physiological parameters, painlessness, clear consciousness and normal muscle strength of lower limb.
15851641|NCT04029740|Behavioral|CBT- both internet and face to face|There are a few common psychotherapies for treating PD, with Cognitive Behavioral Therapy (CBT) as the most common. The most known type of CBT for treating PD consists of two major strategies: cognitive restructuring, and interoceptive and structured exposure to bodily sensations that have become associated with panic attacks (D H Barlow, 1997). The ICBT therapy is based on Barlow and Craske's (2007) protocol for treating PD with elaborations (Huppert & Baker-Morissette, 2003). It includes six modules containing psychoeducation, cognitive restructuring, exposures, acceptance, and consolidation of gains and relapse prevention. The online modules include reading passages, worksheets, videos, and homework assignments. After completing each module, participants practice related skills and complete homework assignments. The treatment is up to 16 weeks long; participants are encouraged to complete the treatment within this time period, and reminders are sent to monitor their progress.
15851642|NCT04029740|Other|No intervention|Healthy controls will not receive any intervention.
15851643|NCT04029727|Dietary Supplement|Combination of Plant Extracts (BSL_EP025)|Each participant will consume 2 capsules daily at lunch for 8 weeks.
15851644|NCT04029727|Dietary Supplement|Placebo|Each participant will consume 2 capsules daily at lunch for 8 weeks.
15851645|NCT04029714|Procedure|Active Surveillance|Active monitoring of prostate cancer and curative treatment if there are signs of tumor progression.
15851646|NCT04029701|Drug|Ruyizhenbao Pill|Ruyizhenbao Pills are provided by Jinhe Tibetan Pharmaceutical Co., Ltd. Chinese national medicine permission number:Z63020289、Z63020064. Medication method: oral 4 pills once, twice a day, 4 weeks in a row.
15851676|NCT04029532|Device|Body composition|Ask participants to supine on bed for 10 minutes, connect electrodes on their right wrist and right foot. Measure body composition.
15986374|NCT02990403|Drug|Immunoglobulin|
15851647|NCT04029701|Drug|Placebo of Ruyizhenbao Pill|Placebo is provided by Jinhe Tibetan Pharmaceutical Co., Ltd.，which is made of malt dextrin as a matrix, similar shape and same color to the Ruyizhenbao Pill. Medication method: oral 4 pills once, twice a day, 4 weeks in a row.
15851648|NCT04029688|Drug|Idasanutlin|Idasanutlin will be administered as an oral medication once daily on Days 1-5 of a 28-day cycle.
15851649|NCT04029688|Drug|Venetoclax|Venetoclax will be administered orally at the adult dose equivalent (adjusted by body weight) of 400 milligrams (mg) in participants with neuroblastoma and the adult dose equivalent of 600 mg in participants with leukemia.
15851650|NCT04029688|Drug|Cyclophosphamide|Cyclophosphamide will be administered once daily on Days 1-5 of each 28-day cycle at 250 milligrams per meter squared of body surface area (mg/m^2) as an intravenous (IV) infusion.
15851651|NCT04029688|Drug|Topotecan|Topotecan will be administered once daily on Days 1-5 of each 28-day cycle at 0.75 mg/m^2 as an IV infusion.
15851652|NCT04029688|Drug|Fludarabine|Fludarabine will be administered once daily on Days 1-5 of each 28-day treatment cycle at 30 mg/m^2 as an IV infusion.
15851653|NCT04029688|Drug|Cytarabine|Cytarabine will be administered once daily on Days 1-5 of each 28-day treatment cycle at 2000 mg/m^2 as an IV infusion.
15851654|NCT04029688|Drug|Intrathecal Chemotherapy|All participants with leukemia, irrespective of arm, will receive intrathecal chemotherapy on Day 1 of each 28-day treatment cycle. Intrathecal chemotherapy will consist of either single-agent cytarabine or methotrexate, or a combination of methotrexate, cytarabine, and hydrocortisone, at appropriate age-based dosing as specified in the protocol.
15851655|NCT04029675|Dietary Supplement|Vitamin C|Vitamin C is a strong antioxidant and has been shown to regenerate other antioxidants such as vitamin E, vitamin C also play an important role in immune function
15851656|NCT04029662|Behavioral|Valsalva Maneuver|Performing Valsalva maneuver will reduce the pain intensity during spinal needle insertion.
15851657|NCT04029649|Drug|Beta-1,3/1,6-D-Glucan|Beta-1,3/1,6-D-Glucan capsule three times daily for 90 days
15851658|NCT04029649|Drug|Placebo|Placebo capsule three times daily for 90 days
15851659|NCT04029636|Other|Inhaled Hyperpolarized Xenon-129|How hyperpolarized 129Xe MRI measurements of lung structure and function change over time in a population at high risk for LONIPC related to their transplant
15851660|NCT04029623|Other|Partnered Rhythmic Rehabilitation (PRR)|Partnered Rhythmic Rehabilitation (PRR) is moderate intensity, cognitively-engaging social dance that targets postural control systems. PRR involves learning complex stepping patterns and fosters tactile communication of motor goals between partners, enhancing social interaction's effect on cognition. Class sizes will consist of 10 or fewer pairs of participants with pAD and partners to maximize safety. Participants will engage in partnering exercises on how to interpret motor goals through touch, exercises to develop understanding of temporal relationship of movement to music, novel step introduction, connecting previously learned and novel step elements. Classes include practicing previously-learned steps, a 20-minute standing warm-up, and partnering and rhythmic enhancement exercises.
15851661|NCT04029623|Other|Group walking (WALK)|WALK sessions consist of 10 minutes of warm-up, and evaluation/tips for practicing safe walking form mechanics (i.e., head up, shoulders relaxed, abdominals engaged, heel strike, roll and toe off; keep natural stride length, and speed up cadence if increased speed is desired), 55 minutes of walking with breaks, and 20 minutes of balance and stretching. WALK will take place in small groups with research assistants and trained family members and/or caregivers to control for social effects/contact of intervention. Participants of similar walking abilities will be 'buddied' with research assistants and trained physical therapy students who will act as group backmarkers, although participants will lead the pace. WALK participants will keep walking logs documenting their progress. WALK is expected to expend 3 metabolic equivalents (METs), like that of PRR.
15851662|NCT04029610|Procedure|Local anesthesia with lidocaine and adrenalin.|Local anesthesia with lidocaine and adrenalin.
15851663|NCT04029610|Drug|lidocaine and adrenalin|lidocaine and adrenalin
15851664|NCT04029610|Drug|lidocaine and arterial blockage|lidocaine and arterial blockage
15851665|NCT04029597|Behavioral|Remote Patient Monitoring|Families participating in the study will receive standard medical care as well as the RPMS. The RPMS was developed in collaboration with the University of Mississippi Medical Center (UMMC) Center of Telehealth. Patients enrolled in this open trial of the RPMS will interact with the RPMS system on a daily basis and with UMMC's Center for Telehealth nurse care coordinators and research and clinical staff on an as needed basis. The RPMS will provide patients with include an electronic tablet (i.e., iPad) and the ability to receive data from the patient's weight scale and pedometer. Patients will be asked to wear the pedometer daily to track engagement in physical activity and weigh themselves weekly to track weight during the 3 month period. Educational information specific to pediatric obesity and healthy eating and engagement in physical activity will be presented daily through brief presentations and video clips.
15851666|NCT04029584|Drug|rifampin IV|A 30-min intravenous infusion of rifampin 600mg in 10ml Normal Saline will be used to inhibit hepatic OATP1B1 transporters.
15851667|NCT04029584|Drug|Rifadin 300Mg Capsule|Rifadin 600mg by mouth as two 300mg rifadin capsules
15851668|NCT04029584|Drug|Fluvastatin 20 MG|one oral dose of fluvastatin (Lescol ) 20mg capsule
15851669|NCT04029571|Drug|TCM-FMD|"Apply fastening-mimicking diet combined with a dispelling dampness meal replacement. For the convenience of implementation, a cycle of 4 weeks. The first 5 days of each cycle is the calorie restriction stage (daily calorie about 800kcal). The traditional Chinese medicine with dampness effect is used as the main source of calories in this stage. The normal diet is carried out under the guidance of a professional dietitian for the next 23 days. Study for 12 weeks."
15851670|NCT04029571|Other|FMD|"A grain package is used to replace the dispelling dampness meal replacement, and the other thing is the same as the proposal in TCM-FMD."
15851671|NCT04029558|Dietary Supplement|Combination of Plant Extracts (BSL_EP025)|Each participant will consume 2 capsules daily at lunch for 8 weeks.
15851672|NCT04029558|Dietary Supplement|Placebo|Each participant will consume 2 capsules daily at lunch for 8 weeks.
15851673|NCT04029545|Device|PN40082|1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w.
15851674|NCT04029532|Device|Respiratory exchange ratio|Ask participants to supine on bed, using a ventilator hood cover upon their head. Measure respiratory exchange ratio for 15 minutes.
15851677|NCT04029532|Behavioral|Eating behavior|Fill in questionnaire (Three-Factor Eating Questionnaire, revised 18-item, TFEQ-18).
15851678|NCT04029532|Behavioral|Physical activity recall|Fill in questionnaire (Seven-days Physical Activity Recall, 7-d PAR).
15851679|NCT04029532|Behavioral|Depression|Fill in questionnaire (Mongomery-Asberg Depression Rating Scale, MADRS).
15851680|NCT04029532|Behavioral|Body image|Fill in questionnaire (multi-directional self-body relationship questionnaire (MBSRQ), figure rating scale (FRS)).
15851681|NCT04029519|Device|PN40082|PN40082 (manufactured by Prollenium Medical Technologies) is a clear, colorless gel in 1.0 mL pre-filled syringes with 25 mg/mL of stabilized hyaluronic acid and lidocaine 0.3% w/w.
15851682|NCT04029480|Drug|Ertugliflozin 5 mg|Ertugliflozin 5 mg, oral, 1 tablet QD
15851683|NCT04029480|Drug|Ertugliflozin 15 mg|Ertugliflozin 15 mg, oral, 1 tablet QD
15851684|NCT04029480|Drug|Placebo|Placebo to ertugliflozin 15 mg, oral, 1 tablet QD
15851685|NCT04029480|Drug|Placebo|Placebo to ertugliflozin 5 mg, oral, 1 tablet QD
15851686|NCT04029480|Biological|Insulin|The initiation and titration of insulin will be at the discretion of the investigator, based on local/regional/country guidelines.
15851687|NCT04029480|Drug|Metformin|Participants will receive stable dose of background metformin.
15851688|NCT04029467|Drug|Dexmedetomidine|addition of dexmedetomidine to ropivacaine as an adjuvant in ESP block to assess wether or not it prolongs its duration of action
15851689|NCT04029454|Biological|birth dose vaccination against hepatitis B strategy|"Complex intervention targeting healthcare workers and involving:
~training on hepatitis B awareness and management
~training on EPI vaccination and cold chain
~training on the modalities for the birth dose administration
~the use of a monovalent unidose vaccine against Hepatitis B"
15851690|NCT04029441|Other|the eradication Hp|the eradication of Hp based on antimicrobial susceptibility test
15851691|NCT04029428|Drug|90Y-DOTATATE|Total activity of 90Y DOTATATE, 4x3.7GBq (14.8 GBq). Single session of i.v. infusion of 90Y DOTATATE administered for 20 min via infusion pump with co-infusion of amino-acids solution 1000ml for 1h before and then et least 6h after 90Y DOTATATE infusion. Therapy consists up to 4 cycles at 8 ± 2 weeks between each other.
15851692|NCT04029428|Drug|(177Lu-DOTAOTyr3)Octreotate|Total activity of 177Lu DOTATATE, 4x5.55GBq (22.2 GBq). Single session of i.v. infusion of 177Lu DOTATATE administered for 20 min via infusion pump with co-infusion of amino-acids solution 1000ml for 1h before and then et least 6h after 177Lu DOTATATE infusion. Therapy consists up to 4 cycles at 8 ± 2 weeks between each other.
15851693|NCT04029428|Drug|90Y DOTATATE and 177Lu DOTATATE (mix each of 50%)|Total activity of 90Y DOTATATE and 177Lu DOTATATE, 4x3.7GBq (14.8 GBq 50% each 90Y and 177Lu). Single session of i.v. infusion of 90Y and 177Lu DOTATATE administered for 20 min via infusion pump with co-infusion of amino-acids solution 1000ml for 1h before and then et least 6h after 177Lu DOTATATE infusion. Therapy consists up to 4 cycles at 8 ± 2 weeks between each other.
15851694|NCT04029402|Other|RNA sequencing|Transcriptomic analysis of kidney biopsy tissue, and linking with slope of eGFR decline
15851695|NCT04029389|Device|Injection|Local corticosteroid injection
15851696|NCT04029389|Device|Tibial nerve block|Tibial nerve block
15851697|NCT04029389|Other|Conservational therapy|Only exercise and foot insoles
15851698|NCT04029376|Drug|Iberogast®|The medication was applied 3 times 20 drops per day before or at meals with some liquid, ideally to one week insofar.
15851699|NCT04029363|Device|HighLife Transcatheter Mitral Valve Replacement|Transcatheter Mitral Valve Replacement
15851700|NCT04029350|Drug|Anlotinib Combined With Osimertinib|"Anlotinib：12mg/capsule, take once when limosis in the morning. If patients suffer from AEs, they can get declined dosage (10mg or 8mg).
~Osimertinib：80 mg/tablet， per os (p.o.) daily. It should be continued until disease progression or intolerable toxicity or patients withdraw of consent."
15851701|NCT04029337|Device|HighLife Transcatheter Mitral Valve Replacment|Transcatheter mitral valve replacement
15851702|NCT04029324|Procedure|tooth extraction|Under local anesthesia, tooth will be extracted atraumatically.
15851703|NCT04029324|Procedure|Implant placement|Dental implants will be placed according to the instructions in fresh sockets or alveolar ridge.
15851704|NCT04029324|Procedure|Bone augmentation|Bone substitute will be used to augment or maintain the bone contour.
15851705|NCT04029324|Procedure|Coronally repositioned flap|After periosteal releasing incision, mucoperiosteal flap will be sutured at a more coronally position
15851706|NCT04029311|Device|Nuance Pro|Study compares Nuance Pro plus Automatic Positive Airway Pressure (autoPAP) vs TAP PAP plus autoPAP
15851707|NCT04029311|Device|autoPAP|autoPAP
15851708|NCT04029311|Device|TAP PAP|TAP PAP
15851709|NCT04029298|Behavioral|Lifestyle Interventions|Educational based intervention to enhance lifestyle modifications such as diet, exercise, patient activation, and medication adherence
15851710|NCT04029285|Other|Exergaming|The exergaming group played six IREX® exergames. Those in the TGB group performed exercises that were matched to the IREX® exergames for: movement patterns required, physiological demands, sequence, duration and mode of exercise by adopting open and closed kinetic chain movements, in the same range and loading, across both groups. Each IREX® exergame was played for two minutes and was repeated three times within a session. TGB exercise was conducted in sets of two minutes duration, repeated three times within a session. In both groups participants were given rest periods of 10 to 30 seconds, or longer, if required, between exergames or TGB exercise sets.
15851711|NCT04029272|Drug|Metformin|500 mg tid for 12 weeks
15851712|NCT04029272|Drug|Exenatide 2 MG|Exenatide injection once weekly for 12 weeks
15851713|NCT04029259|Diagnostic Test|Brain MRI|Brain MRI diagnoses tromboembolic lesions or bleeding to the cerebrum and is part of preoperative diagnostic tests before carotid surgery. After surgery brain MRI may present New lesions related to surgery, clinically significant or insignificant. Our goal is to evaluate the relevance of this modality in carotid surgery..
15851714|NCT04029246|Behavioral|Follow up phone call|Telephone call to ask if patient has received letter and whether they would like an appointment
15851715|NCT04029246|Behavioral|Incentive|Offer of a shopping voucher if patient attends for appointment
15851716|NCT04029233|Device|Occlutech PFO Occluder|The Occlutech PFO Occluder is a medical device for transcatheter closure of PFO.
15851787|NCT04028557|Other|Decision Support Systems, Clinical|Active computerized clinical decision support alert within the electronic health record that recommends initiation of an evidence-based beta blocker for heart failure and reduced ejection fraction.
15986375|NCT02990403|Drug|Dydrogesterone|
15851717|NCT04029220|Behavioral|Parent Peer Navigation|Parent Peer Navigation (PPN) is implemented by trained providers with lived experience, who are supported by training and coaching protocols. The role of PPN provider is to engage caregivers in necessary treatment for their children and prepare them to independently navigate the child serving system, community-based resources, and ongoing opportunities for support. PPN providers will support families who are just entering he child-serving systems for 6 months on a weekly basis during which they will: help link families with formal and informal supports; instill confidence and coping skills; assist in the development of goals and crisis plans; and serve as an advocate for resolution of issues. Also, the PPN provider helps the family to learn to navigate systems and advocate for their needs, prepares families for meetings and treatment sessions, helps identify ways for parents to practice self-care; and promotes family choice and shared decision making.
15851718|NCT04029207|Procedure|Cesarean section|Abdominal, operative delivery of the fetus
15851719|NCT04029194|Behavioral|Assistance with old age pension application|The intervention will offer elderly assistance in applying for the old age pension.
15851720|NCT04029181|Other|Anti-CD8 PET imaging agent|An imaging agent radiolabelled with 89Zr developed for in human PET imaging of CD8
15851721|NCT04029155|Device|Lung biopsy|Transbronchial Needle Aspiration performed via a ultra thin bronchoscope
15851722|NCT04029142|Diagnostic Test|Review of routine lab data|Review of routine lab data from pregnant women (first trimester)
15851723|NCT04029129|Other|Air filtration and building envelop modifications|Air filters and closing and sealing of windows and doors was used to reduce infiltration of air pollution from outdoors in rooms next to major highways at rush hour.
15851724|NCT04029116|Drug|Fluconazole Tablet|150 mg every 72 hours for 3 doses
15851725|NCT04029116|Drug|IBREXAFUNGERP|300 mg BID (one day) every 4 weeks for a total of 6 dosing days
15851726|NCT04029116|Drug|Placebo oral tablet|BID (one day) every 4 weeks for a total of 6 dosing days
15851727|NCT04029103|Other|knowledge, behaviour, self efficacy|Knowledge, behavior and self-efficacy of both groups were measured before and after the study.
15851728|NCT04029090|Drug|MCI-186|A single dose of 60 mg MCI-186 over 60 min will be intravenously administered.
15851729|NCT04029090|Drug|MCI-186|A single dose of 300 mg MCI-186 over 60 min will be intravenously administered.
15851730|NCT04029090|Drug|Placebo|A single dose of 0.9% w/v saline over 60 min will be intravenously administered.
15851731|NCT04029077|Other|NA: intervention is not part of the study|NA: it is not an interventional study
15851732|NCT04029051|Other|Focus thoracic ultrasound for dyspnea diagnosis|Focus thoracic ultrasound is composed by an advanced cardiac ultrasound with Doppler measures and a lung ultrasound.
15851733|NCT04029038|Biological|Autologous CD19/CD22 Chimeric Antigen Receptor T-cells|Given IV
15851734|NCT04029038|Drug|Cyclophosphamide|Given IV
15851735|NCT04029038|Drug|Fludarabine|Given IV
15851736|NCT04029025|Procedure|Workflow A|Dentalwings DWOS Intraoral Scan (IOS A) + Dentalwings DWOS Implant Prosthetics Lab-Software (CAD A)
15851737|NCT04029025|Procedure|Workflow B|3Shape TRIOS Pod Intraoral Scan (IOS B) + Straumann CARES Lab-Software (CAD B)
15851738|NCT04029025|Procedure|Workflow C|Conventional Impression + conventional porcelain-fused-to metal iFDP (LabS C/CAD C)
15851739|NCT04029012|Drug|Methoxyflurane|Methoxyflurane inhaler before Rezum procedure
15851740|NCT04028999|Device|Evaluate the effects of the EO31 shoulder sling in adults post-stoke|Investigator want to evaluate the efficient of the EO31 shoulder sling in adults post-stroke. The EO31 shoulder sling is made-to-measure shoulder pads for upper limb after cerebrovascular accident
15851741|NCT04028986|Drug|Ulipristal Acetate 5 MG Oral Tablet|use of ulipristalacetate OR surgery before fertility treatment
15851742|NCT04028973|Other|Single then dual task situation|Firstly, the participants have to perform the fatiguing task in simple task condition (control condition, i.e., muscle contraction alone). Secondly, few days later (between 3 and 7 days later), the participants have to perform the same fatiguing task with a concomitant memory cognitive task (i.e. dual-task condition).
15851743|NCT04028973|Other|Dual then single task situation|Firstly, the participants have to perform the fatiguing task in dual-task condition (i.e. muscle fatiguing contraction with a concomitant memory cognitive task). Secondly, few days later (between 3 and 7 days later), the participants have to perform the same muscle fatiguing task without a concomitant memory cognitive task (i.e. control condition).
15851744|NCT04028960|Drug|Regular insulin (Humulin-R), intranasal route|Humulin-R insulin is approved by the U.S. Food and Drug Administration (FDA) for the treatment of diabetes.
15851745|NCT04028960|Device|SipNose intranasal device|The SipNose device is an aerosol nasal delivery platform that uses pressurized delivery through the discharge of compressed air, resulting in an aerosol that delivers the drug in a narrow plume geometry, which targets the olfactory epithelium in the upper nasal cavity. From the olfactory epithelium, therapeutics rapidly reach the central nervous system, traveling extracellularly along the olfactory nerves. The device is not currently commercially available, but numerous studies have demonstrated its ability to intranasally deliver radiolabeled and therapeutic compounds to the brain.
15851746|NCT04028947|Procedure|Prophylactic Infrapatellar Saphenous Neurectomy in Primary Total Knee Arthroplasty|Prophylactic infrapatellar saphenous nerve neurectomy will be performed at the same time as the TKA.
15851747|NCT04028921|Other|No intervention|This is a cross-sectional study; no intervention
15851748|NCT04028908|Diagnostic Test|radiographs in two views of the tibia|The anterior tilt angle of the tibia will be measured by two specialized radiologists according to a specific radiological angle measurement tool (PACS Sectra IDS7TM, Linköping, Sweden).
15851749|NCT04028895|Diagnostic Test|Dosage of IRAP during OGTT|Visit 1: oral glucose tolerance test. visit 2: hyperinsulinemic euglycemic clamp
15851750|NCT04028882|Other|Signaling, metabolomic and transcriptomic analysis|Signaling, metabolomic and transcriptomic analysis
15851751|NCT04028869|Drug|Glycyrrhizic acid preparation|To analyze the clinical effect of glycyrrhizic acid preparation for autoimmune liver disease for 144 weeks and the safety during treatment
15851752|NCT04028856|Drug|interferon|Chronic hepatitis B patients were treated with interferon for 48 weeks
15851788|NCT04028544|Drug|Qishenyiqi dropping pills|on the basis of standard treatment, adding QSYQ dropping pills 1 bag each time, 3 times a day
15851789|NCT04028544|Drug|Placebo|on the basis of standard treatment, adding placebo 1 bag each time, 3 times a day
15851753|NCT04028843|Behavioral|Healthy Beginnings|The program includes a 24 week intensive behavior modification program that targets healthy gestational weight gain through self-monitoring of weight and activity data, automated prescriptive feedback from the smartphone application, personalized feedback from counselors and, evidence-based behavioral intervention delivered throughout pregnancy.
15851754|NCT04028830|Other|Visit to GPs to promote good antibiotic prescription with the help internet tool for decision: ANTIBIOCLIC|Visit to GPs to promote good antibiotic prescription with the help internet tool for decision: ANTIBIOCLIC
15851755|NCT04028830|Other|Visit to GPs to promote good antibiotic prescription without presentation of the internet tool for decision support|Visit to GPs to promote good antibiotic prescription without presentation of the internet tool for decision support
15851756|NCT04028817|Device|photobiomodulation|the intervention will occur twice a week, 18 sessions will be performed, during the sessions will be applied sublingual laser in a single point, with wavelength of 808 nm, diameter of 0.4 cm, with irradiance of 0.8 w / cm2, for 360 s, the laser applied will be of continuous wave with energy of 36J.
15851757|NCT04028817|Device|placebo photobiomodulation|the intervention will occur twice a week, 18 sessions will be performed, during the sessions will be applied a placebo sublingual laser for 360 s.
15851758|NCT04028804|Procedure|FDG PET|Each patient will receive a single intravenous injection of FDG (5.18 MBq/kg (0.14 mCi/kg)) using a minimum dose of 37 MBq (1 mCi) up to a maximum of 370 MBq (10 mCi) with an accepted 10%-20% variation since dose variation can occur when small concentrated volumes of FDG are being drawn up or radioactive decay has reduced the amount of available.
15851759|NCT04028804|Procedure|FLT PET|The FLT PET scan will be performed 1-5 days after FDG PET in order to ensure consistency between imaging findings. Each patient will receive a single intravenous injection of FLT (5.18 MBq/kg (0.14 mCi/kg)) using a minimum dose of 37 MBq (1 mCi) up to a maximum of 370 MBq (10 mCi) with an accepted 10%-20% variation since dose variation can occur when small concentrated volumes of FLT are being drawn up or radioactive decay has reduced the amount of available.
15851760|NCT04028791|Other|Exercise on ergocycle|The exercise includes 15 minutes of warm up, then participants will be asked to pedal as fast as possible for 6 seconds. The test of 6 seconds will be repeated twice or more with recovery each time
15851761|NCT04028778|Drug|Gefitinib|Gefitinib 250mg, p.o., qd, D1-D21; 3 weeks one cycle.
15851762|NCT04028778|Drug|Anlotinib Hydrochloride|Anlotinib hydrochloride capsule 12mg, p.o., qd, D1-D14; 3 weeks one cycle.
15851763|NCT04028778|Other|Placebo|Placebo simulating anlotinib hydrochloride capsule 12mg, p.o., qd, D1-D14; 3 weeks one cycle.
15851764|NCT04028765|Drug|Misoprostol|As above
15851765|NCT04028765|Drug|Oxytocin|As above
15851766|NCT04028752|Biological|Blood collected specifically for this study|The subject will be sitting in a chair, and a needle will be inserted into a vein in the arm. Study Team will draw about 45ml or 3 tablespoons of whole blood for research.
15851767|NCT04028739|Dietary Supplement|curmin|curcumin 90mg/day cross-over
15851768|NCT04028726|Other|Back-squat exercise|Participants begin with a 5 min dynamic warm-up. Then, they will perform two sets of five repetitions at 40-60% of predetermined 1-repetition maximum (1-RM). The clustered bout will be 4 sets of 2 clusters of 5 repetitions with a 30-second intra-set rest between clusters, and 90-second inter-set rest at a load 70% of 1-RM. The traditional bout will be 4 sets of 10 repetitions with a 120-second inter-set rest at a load 70% of 1-RM.
15851769|NCT04028713|Procedure|Venapuncture|Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of adalimumab.
15851770|NCT04028713|Procedure|Dried blood spot|A subset of patients will sample additionally by using the dried blood sampling technique.
15851771|NCT04028713|Drug|Dose reduction|Adalimumab dosing frequency will be lowered in patients who have supratherapeutic serum trough levels of adalimumab.
15851772|NCT04028700|Biological|G6PD Deficient Red Blood Cell Transfusion|Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient.
15851773|NCT04028700|Biological|Non-G6PD deficient Red Blood Cell Transfusion|Patients will receive a red blood cell transfusion. The last 50 mL of the transfusion will be labeled with chromium to allow investigators to study the lifespan of the red blood cells transfused into each patient.
15851774|NCT04028687|Device|Taperloc Complete Stem|Patients that have been implanted with a Taperloc Complete Stem to improve hip malfunction/disease.
15851775|NCT04028674|Device|Laryngeal Pacing Device|Device is an implantable neurostimulation system designed to deliver low-intensity electrical impulses to nerve structures.
15851776|NCT04028661|Device|3D printed Modified Twin Block Appliance|It is a functional appliance for mandibular advancement designed digitally on virtual models.
15851777|NCT04028635|Behavioral|Cognitive-behavioral therapy plus VR-based body exposure|Combine usual cognitive-behavioral treatment (CBT) sessions with additional five VR-based body-exposure therapy sessions.
15851778|NCT04028635|Behavioral|Cognitive behavioral therapy|Usual CBT
15851779|NCT04028622|Other|TCAD (telemedicine anesthesia consultation)|Patients in the TCAD (telemedicine anesthesia consultation) group, arrange their bookings on a website and realise their anesthesia consultation from a platform from home
15851780|NCT04028609|Behavioral|Healthy at Home|In addition to receiving medical services as usual, subjects receive services from Community Healthy Workers during the transition from the hospital to their community residence.
15851781|NCT04028609|Other|Services as Usual|Routine medical services
15851782|NCT04028596|Drug|Paracetamol|once, 1000mg, 2 h before ECT session
15851783|NCT04028596|Drug|Nimotop|once, 60mg, 2 h before ECT session
15851784|NCT04028583|Other|PIM-Check|In the PIM-Check group, a medication review will be conducted using PIM-Check within 72 hours of patient's admittance to the unit. The physician will decide whether to accept these recommendations or not and implement prescribing changes if agreed.
15851785|NCT04028583|Other|STOPP/START|In the STOPP/START group, medication lists will be analyzed within 72 hours of patient's admittance and optimized according to STOPP/START criteria. The second physician will decide whether to accept these recommendations or not and implement prescribing changes if agreed.
15851786|NCT04028570|Radiation|Varying Doses of Background and Boost RT|3+3 radiation dose escalation model to see the maximum tolerated dose for background and boost radiation therapy.
15988702|NCT02973191|Drug|JCAR015|
15851790|NCT04028518|Drug|r-PA|"Drug: r-PA Dose: stick 18 mg;
~Mode of admin:
~The high-dose group (18 mg + 18 mg) was divided into two intravenous injections. the first intravenous bolus injection of 18mg,after 30mins, the second intravenous bolus injection of 18 mg, Push slowly for more than 2mins each time."
15851791|NCT04028518|Drug|r-PA|"Drug: r-PA Dose: stick 18 mg;
~Mode of admin:
~The low-dose group (12 mg + 12 mg) was divided into two intravenous injections, the first intravenous bolus injection of 12 mg, after 30mins, the second intravenous bolus injection of 12 mg, Push slowly for more than 2mins each time."
15851792|NCT04028518|Drug|Alteplase for Injection|"Drug: Alteplase for Injection Dose:50mg; 20mg
~Mode of admin:
~0.9 mg/kg (maximum dose of 90 mg) intravenous, 10% of which was injected intravenously within the first 1min, and the rest continued intravenous infusion for 1 h."
15851793|NCT04028505|Drug|Terlipressin Injectable Product|"Intravenous terlipressin will be obtained from Clinical Trials Unit, AKUH pharmacy in standard IV infusion form.
~Participants who are randomized to the intervention arm will be administered a continuous infusion of Terlipressin at a rate of 0.5mg/hour for the first 24 hours. Participants randomized into the control group will be administered a bolus form of Terlipressin at a rate of 2mg every six hourly for the first 24 hours respectively. In case of weekends/public holidays intravenous terlipressin will be obtained from the main pharmacy of AKUH."
15851794|NCT04028492|Drug|Tradipitant|BID
15851795|NCT04028492|Drug|Placebo|BID
15851796|NCT04028479|Diagnostic Test|Biomarker Testing (L)|Patients who have received biomarker testing that could affect prognosis or treatment decisions. This generally excludes testing done to assist in the diagnosis of disease or histology where there is no treatment implication from this testing.
15851797|NCT04028479|Drug|Systemic Treatment (T)|Patients who have received any treatment as part of their care. This refers to systemic treatment, but also allows other non-drug related interventions such as surgery or radiotherapy as part of the longitudinal care of the patient.
15851798|NCT04028479|Other|Patient Reported Outcomes (P)|Patients who have provided information about their disease, treatment course, or experience directly to the study using a patient facing tool or device.
15851799|NCT04028466|Drug|Vonoprazan|Patients will be randomized to receiving vonoprazan 20mg tablet or omeprazole 40mg capsule, either of which will be taken 30 minutes before the first meal of the day for 14 days
15851800|NCT04028466|Drug|Omeprazole|Patients will be randomized to receving vonoprazan 20mg tablet or omeprazole 40mg capsule, either of which will be taken 30 minutes before the first meal of the day for 14 days
15851801|NCT04028453|Other|Survey|There will be a first part with a retrospective study in order to collect pregnancy data to answer to the primary endpoint. Then, there will be a prospective part where mothers and their children will have to answer an evaluation survey.
15851802|NCT04028440|Biological|Autologous γδT cells|Cells will be extracted by apheresis, followed by expanding and activating. The autologous γδT cells product will be adoptive transferred.
15851803|NCT04028427|Behavioral|Values-plus-goals intervention|The VGI is a four-week intervention, adapted from an existing online value-affirmation and goals intervention (Kingston & Ellett, 2014) and an existing 'Living Well with Physical Health Conditions' programme handbook. Participants are first introduced to the concept of values as understood in Acceptance and Commitment Therapy. They are then asked to complete a card-sort task, which involves organising ten life domains according to their perceived level of importance. Participants will be asked to choose one values that is the most important and meaningful to them and to write for up to 10 minutes about it, thinking about why it is meaningful to them. Following this, participants will be given information on how to set value-based 'SMART' goals and asked to choose one to focus on over the next month. Participants will be sent a reminder e-mail every week over the 4 weeks, asking them to review their progress towards the SMART goal they set themselves.
15851804|NCT04028427|Behavioral|Mindfulness-based intervention|The MBI is a four-week intervention, where participants are introduced to the concept of mindfulness and acceptance as understood in ACT (Hayes et al., 1999). They will be asked to complete a 10-minute health-focused mindfulness meditation exercise by listening to a recording of a script focusing on cultivating mindful awareness of internal experiences, particularly in relation to diabetes, and practising making room for any difficult internal experiences. This will be followed by some prompts to promote reflections related to their diabetes following the exercise. They will be asked to practise this exercise 3-4 times a week over a four-week period. As a manipulation check, participants will be sent a reminder e-mail every week over the four weeks to record how many times they practised the exercise over the past week.
15851805|NCT04028414|Other|Early Weight Bearing|Patients will be instruction to weight bear as tolerated while in a boot.
15851809|NCT04028375|Other|No intervention|No intervention
15851810|NCT04028362|Drug|Neuromuscular Blocking Agents|Patient who will receive neuromuscular blockade will be follow during their ICU lenght stay.
15851811|NCT04028349|Drug|Ad26.ZEBOV/MVA-BN-Filo|Candidate Ebola Vaccine
15851812|NCT04028336|Other|TITRATION|PEP titration pulmonary opening (PEP-OP) was performed in all patients followed by new LUS and Peso measurement.
15851813|NCT04028323|Drug|Terlipressin|Terlipressin should be administrated intravenously while monitoring heart rate and blood pressure daily.
15851814|NCT04028323|Drug|Octreotide|Octreotide should be continuously intravenously administrated while monitoring heart rate and blood pressure daily.
15851815|NCT04028310|Other|Phonological|"Phase 1: intervention without targeted daily training (30 minutes/ week, for 8 weeks)
~Phase 2: intervention with targeted daily training
~Phonological training (15 minutes/ day, 5 days/week, for 8 weeks)
~Visuo-attentional training (15 minutes/ day, 5 days/week, for 8 weeks)
~Cross-modal training (15 minutes/ day, 5 days/week, for 8 weeks)
~Phase 3: stopping training sessions for 8 weeks"
15851840|NCT04028115|Drug|Ixazomib|Scheduled visits: Patients included in the trial will be treated with Ixazomib 4 mg on day 1, 8, and 15 in a 28-day cycle for up to 24 cycles. Patients will be evaluated every 4th week by a medical doctor, prior to initiation of a new cycle of Ixazomib.
15855772|NCT03996265|Other|Quality-of-Life Assessment|Ancillary studies
15851816|NCT04028310|Other|Visual-attention|"Phase 1: intervention without targeted daily training (30 minutes/ week, for 8 weeks)
~Phase 2: intervention with targeted daily training
~Visuo-attentional training (15 minutes/ day, 5 days/week, for 8 weeks)
~Phonological training (15 minutes/ day, 5 days/week, for 8 weeks)
~Cross-modal training (15 minutes/ day, 5 days/week, for 8 weeks)
~Phase 3: stopping training sessions for 8 weeks"
15851817|NCT04028297|Other|Focus cardiac ultrasound (FoCUS)|
15851818|NCT04028284|Device|HoloLens-guided epidural|To determine whether using the HoloLens tool increases the success of epidural insertion.
15851819|NCT04028284|Other|US-guided epidural|traditional thoracic epidural procedure
15851820|NCT04028271|Device|Comfort-in injection system|local anesthesia during dental treatment
15851821|NCT04028271|Other|conventional injection with dental needle|for local anesthesia during dental treatment
15851822|NCT04028258|Dietary Supplement|Mixture of fibers + Placebo|Study product: mixture of plant-based food fibers (3 weeks) + wash out (2 weeks) + placebo control : plum flakes + maltodextrin (3 weeks)
15851823|NCT04028258|Dietary Supplement|Placebo + Mixture of fibers|Placebo control: plum flakes + maltodextrin (3 weeks) + wash out (2 weeks) + study product: mixture of plant-based food fibers (3 weeks)
15851824|NCT04028245|Drug|Spartalizumab|Spartalizumab at 400 mg weeks x 2 doses prior to radical nephrectomy Infusion
15851825|NCT04028245|Drug|Canakinumab|Canakinumab 300 mg IV Q4 weeks x 2 doses prior to radical nephrectomy Infusion
15851826|NCT04028219|Diagnostic Test|Online surveys|Psychometric measures within 14 online surveys, which is one at each assessment point (before and 3, 6, 9, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120 months after hormonal therapy).
15851827|NCT04028206|Dietary Supplement|Hydroxymethylbutyrate|Hydroxymethylbutyrate supplementation at 3.0 g/day with dietary advice.
15851828|NCT04028206|Device|Low-magnitude High Frequency Vibration (LMHFV)|Low-magnitude High Frequency Vibration is a non-invasive biophysical intervention which provides mechanical stimulation with no reported adverse effects. Our previous studies on bone showed that LMHFV can help boost the patients' bone mineral density (BMD) and muscle health.
15851829|NCT04028206|Behavioral|Elastic-band Exercise|"Subjects enrolled in the elastic-band exercise group will be instructed with 1 session of group training (at baseline) and 1 follow-up home visit (at 4 weeks) including instructions on 5-10 min warm-up and cool-down routines, 30 min chair-based resistance exercises using Thera-Bands as previously reported with training to both upper and lower body muscle groups including both hand and knee extensor muscles. The subjects will be instructed to perform the instructed exercises 3 times per week, one hour after HMB intake, for 12 weeks. The elastic band strengths will be progressively increased from 1.3 kg to 2.1 kg (yellow to green) of tensional force as instructed by a qualified coach in our project team based on each subject's multiple repetition maximum, where multiple repetition maximum is defined by reaching fatigue by 8 repetitions of stretching."
15851830|NCT04028193|Dietary Supplement|Calogen|Polyunsaturated liquid fat supplement
15851831|NCT04028193|Dietary Supplement|Resource Energy|Carbohydrate Supplement
15851832|NCT04028180|Other|p-Menthane,3-8-diol (PMD) Topical Repellent|"p-Menthane,3-8-diol (PMD) is a recommended active ingredient, which has been evaluated for safe use by the U.S. Environmental Protection Agency (USEPA)1. According to the USEPA laboratory exposure of animals to the active ingredient, PMD, this resulted in no adverse effects except eye irritation. The eye irritation potential of the finished product formulation has not been studied; therefore as a precaution, the products will be handled in the same way as the active ingredient. The researcher and participant must wear eye protection during application of the product and the potential for eye irritation is described in the Participant Information Sheet. . Participants will be excluded if they have a known allergy to any of the product ingredients, or any skin condition, which may affect their reaction to the product.
~There isn't a relevant intervention type hence why other is specified. It is to deter mosquitoes landing on the skin of a human."
15851833|NCT04028180|Other|Picaridin Topical Repellent|"Icaridin (trade names include Picaridin) is a known mosquito and midge repellent active ingredient. The active ingredient, Picaridin, has been classified as potentially mildly irritating/uncomfortable to the eyes - participants and researcher will wear safety glasses during handling of the products and the participants will be warned about the potential for irritation during the Informed Consent Procedure. Participants will also be excluded if they have a known allergy to any of the product ingredients, or any skin condition which may affect their reaction to the product.
~There isn't a relevant intervention type hence why other is specified. It is to deter mosquitoes landing on the skin of a human."
15851834|NCT04028167|Drug|Sequential FLOT followed by chemoradiation|Chemotherapy with Docetaxel, Oxaliplatin, and 5-Fluorouracil/ Leucovorin
15851835|NCT04028154|Procedure|Erector Spinae Plane (ESP) Block|ESP Block: Bilateral ESP block and with ultrasound guidance will be applied A total 40 ml, 20 ml bupivacaine 0.5%, 20 ml saline.
15851836|NCT04028154|Procedure|Thoracolumbar interfacial plane (TLIP) Block|TLIP Block: BilateralTLIP block and with ultrasound guidance will be applied A total 40 ml, 20 ml bupivacaine 0.5%, 20 ml saline.
15851837|NCT04028141|Drug|Procedural sedation with ketofol in a 1 on 4 ratio|"The participant was brought to a zone where advanced life support could be optimally administered and where all necessary drugs and materials for treatment of complications are present. Oxygen saturation, continuous electrocardiogram, intermittent blood pressure measurement (every 2 minutes) and capnography were applied. A 20 gauge intravenous line was inserted. The participant was placed in semi-recumbent position and was given oxygen for at least 3 minutes through a non-rebreather mask unless contra-indications applied.
~Ketofol 1 on 4 was prepared by mixing 1ml of ketamine (50mg) and 20ml of propofol (200mg) in a single syringe. It was administrated as a loading dose of 1ml/10kg, corresponding to 0,952mg/kg propofol and 0,238mg/kg ketamine, and followed by titration in aliquots of 0,5ml/10kg every 1 to 2 minutes until desired depth of sedation was achieved, and then every 3-5 minutes to retain the desired depth of sedation. The loading dose was halved if above 65 years."
15851838|NCT04028128|Dietary Supplement|Cocoa group|Athletes performed a training program and consumed 5 g of cocoa (425 mg of flavonoids) mixed with semi-skimmed fat milk, daily for 10 weeks.
15851839|NCT04028128|Dietary Supplement|Placebo group|The athletes performed the same training program of the cocoa group and they took for 10 weeks 5 g of maltodextrin mixed with semi-skimmed fat milk.
15851911|NCT04027439|Drug|Placebos|"Part A: 1 dose of either 50ncg/100ncg/1500ncg/3000ncg/6000ncg or placebo via dry powder inhaler.
~Part B: Patients will receive 4 or 5 repeat dose treatments in crossover fashion - doses will be confirmed after Part A."
15851841|NCT04028089|Behavioral|Diet Modification Group|The diet modification group will receive diet counselling by an experienced dietician at least every four weeks throughout pregnancy starting in the first trimester. The dietary counselling will be guided by the individual glucose profiles obtained through flash glucose monitoring.
15851842|NCT04028089|Other|Regular Diet Group|"Participants of the standard diet will receive general diet counselling on one occasion at the onset of the study."
15851843|NCT04028076|Behavioral|Peers Supporting Health-Literacy, Self Efficacy, Advocacy and Adherence|An 8-week culturally appropriate educational behavioral intervention that consists of structured group diabetes education and follow-up peer support with PAs. There will be 3 separate group education sessions led by a physician, AA pharmacist and AA diabetes educator. All PAs will attend each group session to learn together with their PBs and build social interactions. Weeks 1 and 2 consist of 2-hour group education between the participants and diabetes educator, and participants and pharmacist, respectively. Pre-test intervention data including A1c will be collected in Week 1. In Weeks 3-7, PAs will deliver the intervention content to PBs over the phone as well as help them set a goal towards getting healthy. An existing video/text messaging app, called WhatsApp® will be offered as an option to use to further enhance PA-PB interaction.
15851844|NCT04028063|Drug|doxorubicin with AGEN1884 and AGEN2034|The first cycle of treatment will consist of AGEN2034 and AGEN1884 alone. Beginning with Cycle 2, doxorubicin will be administered every 21 days for a maximum of 6 cycles (Cycles 2-7) with appropriate premedications and pegfilgrastim growth factor support. Doxorubicin will be administered as bolus infusion on day 1 with dexrazoxane cardioprotection. Patients must have central line access for this protocol, including pheresis or trifusion catheter, PICC line, or port. AGEN2034 will be administered every cycle (every 21 days) up to two years. AGEN1884 will be administered every other cycle (Cycle 1, 3, 5, and 7) with maximum of 4 infusions.
15851845|NCT04028050|Drug|Atezolizumab|Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit as determined by the investigator. After the induction phase, participants will begin maintenance therapy with atezolizumab every 3 weeks.
15851846|NCT04028050|Drug|Carboplatin|Carboplatin will be administered after completion of atezolizumab by IV infusion over 30-60 minutes to achieve an initial target AUC of 5 mg/mL/min (Calvert formula dosing) with standard anti-emetics per local practice guidelines.
15851847|NCT04028050|Drug|Etoposide|Etoposide will be administered by IV infusion over 60 minutes following carboplatin administration, during the induction phase on Day 1 through 3 of each cycle. On Days 2 and 3, patients will receive etoposide alone.
15851848|NCT04028037|Procedure|FTPGT|A primary full thickness incision was given at 90 degrees to the long axis of the tooth and directly to the bone, A secondary split thickness incision was performed at 90 degrees to the long axis of the tooth but not directly to the bone, to circumscribe an area that has the same size of the gingival recession you want to cover .in a part of the first incision in order to preserve the area of tissue between them. A partial thickness flap is raised. Then two vertical incisions to the bone on the mesial and distal ends of the graft and one horizontal medial incision is made (under the partial thickness flap), to release it from the surrounding tissue incision were made, inserting the blade as much as possible parallel to the long axis of the teeth, the connective tissue was elevated from the underlying bone with a periosteal elevator.
15851849|NCT04028037|Procedure|SCTG|A primary full thickness incision was given at 90 degrees to the long axis of the tooth and directly to the bone, a falp was elevated, three inner incision eas performed and the connective tissue graft was harvested
15851850|NCT04028024|Drug|Ulinastatin|Ulinastatin 5000U/Kg in 20 ml NS i.v. before occlusion of aorta
15851851|NCT04028011|Diagnostic Test|Novel Wearable device|patient will wear novel wearable device overnight along with normal standard of care
15851852|NCT04027998|Diagnostic Test|strain and applied pressure measurement|Measurement of median nerve strain and applied pressure at proximal carpal tunnel level
15851853|NCT04027985|Other|Kinesiotaping|inesio tape would be applied over the extensor muscles of the affected hand for facilitating the extension of hand. We will apply the tape from the upper 1/3 length of dorsal side of the forearm and split the tape into five equal bars to the distal interphalangeal joint of each finger along the finger bones. This intervention would be executed for five days per week for three weeks.
15851854|NCT04027985|Other|Hand rehabilitation program|In the thirty-minute hand rehabilitation program, a motor-relearning theory would be implemented into the intervention by teaching the participants how to use their upper limb properly without any compensatory motions. Therefore, for establishing a correct movement pattern, an occupational therapist would provide a hand-guided activity, in which the participants could practice reaching movement as well as hand grasp and release in a more natural way. Besides, the therapist would also help the patients release their muscle tone by stretching the spastic muscles for five minutes before and after this hand rehabilitation period.
15851855|NCT04027985|Other|Sham taping|A short piece of kinesio tape would be cut into half and applied over the lateral side of the forearm from the lateral epicondyle till the half of the forearm. The tape would not cover the both the flexor and extensor muscle bellies.
15851856|NCT04027972|Drug|Combination of Neostigmine and Glycopyrrolate|Intravenous or transdermal
15851857|NCT04027972|Device|I-Box by Dynatronics|Electric field conducting drugs through the skin without compromising its integrity
15851858|NCT04027959|Dietary Supplement|Vitamin B12|Diffusion of Vitamin B12 through the skin over 20 minutes under the effect of low amount of direct electric current
15851859|NCT04027946|Drug|LMB-100|Patients will receive LMB-100 on days 1, 3 and 5 of a 21 day cycle for up to 2 cycles.
15851860|NCT04027946|Drug|pembrolizumab|Patients will receive pembrolizumab on day 1 of each subsequent 21 day cycle.
15851861|NCT04027946|Diagnostic Test|Mesothelin Expression|Testing for mesothelin expression performed at screening
15851862|NCT04027946|Diagnostic Test|TrueSight Oncology 500|Testing for ROS1, ALK and EGFR variations performed at screening.
15851948|NCT04027179|Drug|0.12% chlorhexidine digluconate mouthwash|0.12% chlorhexidine digluconate mouthwash (20mL/60 seconds/ 2 times a day/ 3 weeks).
15851949|NCT04027179|Procedure|Periodontal instrumentation|Full-mouth scaling and root planing with manual curettes within 24 hours in two sections 1 hour each.
15851950|NCT04027179|Drug|Placebo mouthwash|placebo mouthwash (20mL/60 seconds/ 2 times a day/ 3 weeks).
15851951|NCT04027166|Drug|Methadone|Methadone will be administered before study procedures
15851863|NCT04027933|Behavioral|Education Based on Standard Patient Simulation|"In the first phase of the study, a theoretical education was provided to the students.
~In the second phase, the students in the experimental and control groups who completed their theoretical education were given data collection forms. In the third phase, after the scales were implemented, there was no intervention with the control group. There was a standard patient implementation to the experimental group. In the fourth phase of the study, after completing the simulation practice, all scales were re-applied both to the experimental and control groups. The scales were applied after the simulation training was completed and students were sent to the clinical practice after three weeks. In the fourth phase of the study, right before the students practiced their trainings and at the end of the initial rotations of the clinical practice, which turned out to be about four weeks later on average, all scales were re-applied both to the experimental and control groups."
15851864|NCT04027920|Drug|Shenghua Decoction|Three days' shenghua decoction treatment
15851865|NCT04027907|Other|Flowcytometry|detect platelet activity in T2DM by surface expression of platelet receptors determined by flowcytometry using different monoclonal antibodies (CD62 and CD63).
15851866|NCT04027894|Drug|Rifamycin SV MMX|200 mg Rifamycin SV-MMX® (CB-01-11)
15851867|NCT04027894|Drug|Placebo to Rifamycin SV-MMX|Placebo to Rifamycin SV-MMX® Placebo tablets correspond to active tablets with respect to size, taste, and appearance.
15851868|NCT04027881|Behavioral|Sit Together and REad|STAR is an evidence-based home-based shared book reading intervention designed to improve the foundational reading skills of preschoolers who are at risk for reading disabilities.
15851869|NCT04027855|Procedure|collection of peripheral blood mononuclear cells from healthy volunteers|"Screening period: All volunteers are required to sign a written informed consent form for the study; after the signing of informed consent form, the demographic data and medical history of the volunteers will be collected, and physical examinations and local laboratory tests will be performed to assess the eligibility of the volunteers. Volunteers who meet all the inclusion criteria and do not meet any exclusion criteria (except for the basic biological indicators of UCAR-T product preparation) will receive peripheral venous whole blood sampling, and the volunteers receiving apheresis based on the assessment results will be enrolled.
~Apheresis period: 5 volunteers who meet the inclusion criteria will undergo collection of peripheral blood mononuclear cells (PBMC) by means of apheresis."
15851870|NCT04027842|Device|Prewarming|In the operating theater, participants allocated in Prewarming group received 10 min-prewarming, which is cutaneous warming before induction of anesthesia. For prewarming, forced air warming system (WarmTouch WT 6000 Warming Unit, Medtronic, Minneapolis, MN, USA) was used and the warming temperature of the device was set to 45°C.
15851871|NCT04027829|Drug|Dexmedetomidine Hydrochloride|Intravenous infusion of dexmedetomidine at the rate of 0.5mcg/kg for 10 min, then 0.5mcg/kg/hr for 50 min.
15851872|NCT04027803|Biological|BCD-148|single intravenous infusion of BCD-148 (900 mg)
15851873|NCT04027803|Biological|Soliris|single intravenous infusion of Soliris (900 mg)
15851874|NCT04027790|Diagnostic Test|Epi proColon|Analysis of DNA methylation status for Septin9 and additional biomarkers
15851875|NCT04027777|Device|Aktiia.product-P0|The optical signals at the wrist are recorded non-invasively by means of the Aktiia.product-P0 investigational device. The BP measurements are further determined from these optical signals and are compared to the reference double auscultation BP readings. A reference-control volume clamp BP reading is recorded simultaneously.
15851876|NCT04027764|Drug|Toripalimab Combined With S1 and Albumin Paclitaxel|Toripalimab 240 mg ，every 2-3 weeks S1：80-120mg，bid；oral，d1-14； Albumin Paclitaxel：120mg/m2，D 1 \8
15851877|NCT04027751|Drug|Tropisetron|Investigators administrated intravenously Tropisetron 5mg before anesthesia induction
15851878|NCT04027751|Drug|Placebos|Investigators administrated intravenously 0.9% saline solution as a placebo
15851879|NCT04027738|Other|PRP|The patients received a single 3-ml injection of PRP. Approximately 10-mL of venous blood was drawn from each patient and centrifuged using an Arthrex autologous conditioned plasma (ACP) kit (a low-leukocyte ACP system), spun at a speed of 1500 rpm for 5 minutes. The platelet concentration obtained was approximately 2-3 times greater than the baseline platelet concentration.
15851880|NCT04027725|Behavioral|Neurofeedback|Neurofeedback experiment will consist of 20 sessions of neurofeedback training, twice or three times a week during seven weeks. Each session will last for 40 minutes. The experimental group will undergo questionnaires, EEG recording and neuropsychological assessments in three-time points, pre-training (T0), post-trianing (T1) and 1 month follow-up (T2). Electroencephalography will be recorded by a technician in EEG for each participant, EEG power spectrum will be calculated in pre (T0) and post neurofeedback training/psycho-pedagogical care at T1 and T2.
15851881|NCT04027699|Procedure|Mini-bolus|"First injection of 2ml/kg (saline solution)
~Second injection of 18ml/kg (saline solution)"
15851882|NCT04027686|Device|Laser Therapy|Adjunctive application of laser therapy in the periodontal pocket
15851883|NCT04027686|Procedure|Non-surgical Scaling and Root Planing|Scaling to remove calculus deposits and root planing to smooth root surfaces
15851884|NCT04027673|Behavioral|TMW ECE Curriculum|The TMW-ECE program will constitute the treatment arm of the study (Cohort A) which will complete the multi-media online professional development course beginning Summer 2019.
15851885|NCT04027660|Device|Immediate Zirconia Dental Implant|"For the Exposed Group the Intervention will be the following
~The Surgical procedure will envolve :
~Administration of Articain 1:200.000
~No flap procedure
~Place a Zirconia Implant on the alveolar post extraction socket
~Place xenograft biomaterial in the jumping gap
~Place a provisional crown/individualized healing abutment
~The Prosthodontic procedure will evolve:
~Final Impression with a IOS
~Placement of the Final Crown
~3 month post crown post op
~3 IOS will be made for volumetric evaluation :
~before tooth extraction
~3 month of Osseointegration for final impression
~3 month after final crown is placed
~Final STL evaluation will be performed on a specialized software for volumetric measurements"
15851886|NCT04027647|Drug|Dacomitinib|30mg of oral dacomitinib is administered daily for one cycle. After one cycle, a toxicity assessment will be conducted. Subjects will then continue dacomitinib at either 30mg or 45mg.
15851952|NCT04027166|Drug|Methadone|Methadone will be delayed (4 hours) until the end of the procedures
15851953|NCT04027153|Other|Fee based delivery|Testing willingness to pay for services to simplify delivery is innovative as the strategy could increase funds for HIV care making home delivery cost neutral.
15855773|NCT03996265|Other|Questionnaire Administration|Ancillary studies
15851887|NCT04027634|Other|Baduanjin program|This exercise program aimed to increase patient participation and control their BW through Baduanjin program. The entire program continued for 3 months (mid-September to mid-December 2014), and the intervention was performed for 60 min 3 times per week; particular attention was paid to the disease characteristics of the patients with chronic schizophrenia and to preventing excessive fatigue. Every session began with a 20-min warm-up, followed by 20 min of Baduanjin program, and ended with a cool-down session. The participants were instructed, with the assistance of a video, to practice Baduanjin program in a group by two authors who are experienced in the psychiatric nurses and had been trained in this program.
15851888|NCT04027621|Device|remote ischemic conditioning|Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 200 mm Hg.
15851889|NCT04027621|Device|sham remote ischemic conditioning|Sham remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min re-perfusion. Limb ischemia was induced by inflation of a blood pressure cuff to 60 mm Hg.
15851890|NCT04027608|Other|Reinforcing value of HED and LED foods in response to snack food monotony|Each child will be asked to eat two different snack foods over the course of two weeks each. The RRV of that food (vs alternative reinforcer) will be tested and baseline and post exposure. Increases in RRv for food after monotony will be considered sensitization to that food. All children will be followed to observe weight change over time for 2 years each.
15851891|NCT04027595|Procedure|Neodymium-doped Yttrium Aluminum Garnet (Nd: YAG) Laser Capsulotomy|A Nd: YAG laser will be used to open the cloudy posterior capsule of the lens to improve central visual acuity.
15851892|NCT04027582|Other|didactic teaching and simulator practice|the trainee will undergo didactic teaching on fiber-optic intubation followed by hands on practice on their assigned simulator
15851893|NCT04027569|Other|Patient Specific Functional Scale|A validated patient reported outcome measure that asks patients to write down activities and score them 0 to 10.
15851894|NCT04027569|Other|PROMIS PF|A computer adaptive, validated patient reported outcome measure that measures physical function on a 1 to 100.
15851895|NCT04027556|Other|low dose CT contrast media - lean body weight|CT contrast media (iobitridol 350mgI/kg) is administrated at a dose of 450mgI/kg based on lean body weight.
15851896|NCT04027556|Other|Standard dose CT contrast media|CT contrast media (iobitridol 350mgI/kg) is administrated at a dose of 560mgI/kg based on total body weight.
15851897|NCT04027543|Combination Product|Neoadjuvant chemoradiotherapy|In most patients, the chemotherapy regimens before surgery were consisted of cisplatin combined with either fluorouracil or taxanes.
15851898|NCT04027543|Procedure|Oesophagectomy|Various surgical oesophagectomy methods were used, such as Ivor Lewis, transthoracic, three-hole, transhiatal, and left transthoracic,and the appropriate surgical approach for each patient was chosen according to the tumour location, size, and depth.
15851899|NCT04027543|Drug|Neoadjuvant chemotherapy|In most patients, the chemotherapy regimens before surgery were consisted of cisplatin combined with either fluorouracil or taxanes.
15851900|NCT04027530|Drug|Ertugliflozin 15 mg|Once daily treatment with oral ertugliflozin 15mg for 4 consecutive weeks
15851901|NCT04027517|Drug|JTZ-951|"Oral tablet
~Dose adjustments as maintenance dose is allowed according to the result of Hb level."
15851902|NCT04027517|Drug|Darbepoetin Alfa|"Intravenous administration
~Dose adjustments as maintenance dose is allowed according to the result of Hb level."
15851903|NCT04027504|Dietary Supplement|Fitabisc|Biscuits containing antioxidants
15851904|NCT04027491|Behavioral|Virtual Reality|"The selected commercial games are aimed mostly to improve upper limb functions. The games will be randomly administered during each session. Each game will be played for approximately 10 minutes, with 5 minutes break between each game session.
~The intervention treatment consists of 12 sessions in 4-week period."
15851905|NCT04027478|Dietary Supplement|FMD|fasting mimicking diet
15851906|NCT04027465|Dietary Supplement|Egg allergy oral desensitization|Subjects in the treatment will begin treatment by undergoing an egg oral challenge. This will confirm that the subject is still allergic to egg and establish the dose of egg the subject can tolerate. The last dose of egg tolerated during the challenge will serve as the first desensitization dose Subjects will then come to the research center every two weeks to receive their dose increases until they reach the maintenance dose of 300 mg. Subjects will then enter the maintenance phase for one year. During this period they will undergo another oral food challenge one month after attaining the maintenance dose
15851907|NCT04027452|Behavioral|Traumatic memory reactivation|"125 word long exposure scripts of their traumatic memory recorded in a neutral tone. All recordings will be approximately 30 seconds in length and the traumatic script will include five of the physical symptoms related to the memory as described by the patient. The script recording is preceded with short instructions for the subject to concentrate on the script and to imagine the described experience for additional 30 seconds right after the script until a short beep sounds. When the participant enters the treatment room, they will be handed an MP3 player with the audio recording. The patient will have several minutes to listen to the recording while the standard pre-ECT procedures are conducted. The participant will listen to the recording prior to each of their ECT treatments for the duration of their acute treatment course."
15851908|NCT04027452|Behavioral|Neutral memory reactivation|"125 word long exposure scripts of a neutral (non-traumatic) memory recorded in a neutral tone. All recordings will be approximately 30 seconds in length and the traumatic script will include five of the physical symptoms related to the memory as described by the patient. The script recording is preceded with short instructions for the subject to concentrate on the script and to imagine the described experience for additional 30 seconds right after the script until a short beep sounds. When the participant enters the treatment room, they will be handed an MP3 player with the audio recording. The patient will have several minutes to listen to the recording while the standard pre-ECT procedures are conducted. The participant will listen to the recording prior to each of their ECT treatments for the duration of their acute treatment course."
15851909|NCT04027439|Drug|Part A: RPL554|1 dose of either 50mcg/100mcg/1500mcg/3000mcg/6000mcg or placebo via dry powder inhaler
15851910|NCT04027439|Drug|Part B: RPL554|Patients will receive 4 or 5 repeat dose treatments in crossover fashion - doses will be confirmed after Part A
15851954|NCT04027140|Device|M/L Taper with Kinectiv Technology Stems and Necks|Patients that have been implanted with a M/L Taper with Kinectiv Technology Stem and/or neck to repair hip malfunction/disease.
15851912|NCT04027426|Behavioral|FBT|FBT will receive a family-based, behavioral intervention for childhood obesity, consisting of group meetings once a week for months 1 to 4, twice a month for months 5 to 6, once a month for months 7 to 12, and once every two months for months 13 to 18 (29 sessions). For all meetings, the child and adult caregiver will be weighed and be provided with feedback, homework will be reviewed, and a behavioral lesson will be presented. At the 60-min meetings, the child and adult will attend separate 40 min group meetings, and then for the last 20 min of the meetings they will meet together with an individual therapist to address specific family-issues by developing behavioral action plans. No goals on variety in RED foods will be provided.
15851913|NCT04027426|Behavioral|FBT+Variety|This condition is FBT with a limited variety prescription. The limited variety prescription reduces the number of different RED foods consumed.
15851914|NCT04027413|Dietary Supplement|fortisip compact protein|(24% protein; 41% carbohydrate; 35% fat)
15851915|NCT04027413|Dietary Supplement|preOp|(100% carbohydrate).
15851916|NCT04027400|Behavioral|computer-assisted rehabilitation|Participant is presented with 10 exercises a day, 3 minutes each. When participant achieves 100% accuracy of the exercise, he/she gets a higher level of exercise. Levels of range from 1-9. Exercises are changed every week by researcher.
15851917|NCT04027387|Biological|TMB-365|An IgG1 monoclonal antibody targeting domain 2 of the CD4 receptor for treatment of HIV-1 infection
15851918|NCT04027374|Procedure|Fetal surgery for MMC repair|Fetal surgery for MMC repair
15851919|NCT04027361|Drug|Amphetamine Extended Release (ER) Tablet 20 mg|A single 20 mg dose of amphetamine ER Tablet, orally administered
15851920|NCT04027348|Drug|Dexamethasone|Given IV
15851921|NCT04027348|Drug|Metoclopramide|Given IV
15851922|NCT04027348|Drug|Octreotide|Given IV
15851923|NCT04027335|Device|leva|Vaginal device used for pelvic floor muscle exercises
15851924|NCT04027322|Drug|Budesonide 0.25 MG/ML Inhalant Solution|"Both medications used for the intervention groups are Glucocorticoids. The effect of glucocorticoids in AP can be attributed to their anti-inflammatory actions. They inhabit the formation of the pro-inflammatory mediators in the endothelial cells of the airways. This will decreases the inflammatory reaction at the pharynges which result in a reduction of throat pain.
~Studies have shown that the use of a single dose of systemic glucocorticoids for acute pharyngitis did not result in significant adverse events and no serious adverse events were reported (7) (8)."
15851925|NCT04027322|Drug|Dexamethasone|"Both medications used for the intervention groups are Glucocorticoids. The effect of glucocorticoids in AP can be attributed to their anti-inflammatory actions. They inhabit the formation of the pro-inflammatory mediators in the endothelial cells of the airways. This will decreases the inflammatory reaction at the pharynges which result in a reduction of throat pain.
~Studies have shown that the use of a single dose of systemic glucocorticoids for acute pharyngitis did not result in significant adverse events and no serious adverse events were reported (7) (8)."
15851926|NCT04027322|Drug|Normal saline|Placebo for the control group.
15851927|NCT04027309|Drug|Gilteritinib|Patients with a FLT3 mutation w ill be randomized to receive either the investigational drug gilteritinib or midostaurin given sequentially to standard induction and consolidation chemotherapy. After completing induction and consolidation treatment, patients who achieve CR/CRi/MLFS will receive maintenance therapy with gilteritinib or midostaurin
15851928|NCT04027309|Drug|Midostaurin|Patients with a FLT3 mutation w ill be randomized to receive either the investigational drug gilteritinib or midostaurin given sequentially to standard induction and consolidation chemotherapy. After completing induction and consolidation treatment, patients who achieve CR/CRi/MLFS will receive maintenance therapy with gilteritinib or midostaurin
15851929|NCT04027283|Dietary Supplement|Erythritol|50g erythritol dissolved in 300mL tap water
15851930|NCT04027283|Dietary Supplement|Erythritol + lactisole|50g erythritol + lactisole (450ppm) dissolved in 300mL tap water
15851931|NCT04027283|Dietary Supplement|D-allulose|25g D-allulose dissolved in 300mL tap water
15851932|NCT04027283|Dietary Supplement|D-allulose + lactisole|25g D-allulose + lactisole (450ppm) dissolved in 300mL tap water
15851933|NCT04027283|Dietary Supplement|Tap water|300mL tap water
15851934|NCT04027283|Dietary Supplement|Tap water + lactisole|300mL tap water + lactisole (450ppm)
15851935|NCT04027270|Other|Physical Therapy|Physical therapy 1-2 times per week for 3 months postoperatively to include lifestyle education, manual therapy, and exercise.
15851936|NCT04027257|Behavioral|Sit Together and Read (STAR)|STAR is an evidence-based home-based shared book reading intervention designed to improve the foundational reading skills of preschoolers who are at risk for reading disabilities.
15851937|NCT04027231|Other|analysis of the synovial fluid|Electrochemical cell analysing the patients' synovial fluid whenever an invasive intervention is medically prescribed
15851938|NCT04027218|Device|Dry heat|The application is made with two sacks of carob seeds during 7 minutes. The sacks are placed on antebrachial anatomical zone, together, and previously heated in the microwave for 0.30 seconds at 850 W of power.
15851939|NCT04027218|Device|High pressure|It will be carried out with the use of the manual aneroid sphygmomanometer fixed at 100 millimeters of mercury. Brand (QUIRUMED) with European Conformity (CE) marking 0197. A pressure lower than the systolic blood pressure, and in each subject will be monitored the radial pulse.
15851940|NCT04027218|Device|Combination of dry heat and high pressure|"The application is made with two sacks of carob seeds during 7 minutes. The sacks may be placed on antebrachial anatomical zone, together, and previously heated in the microwave for 0.30 seconds at 850 W of power; according to instructions for use.
~After 7 minutes, the pressure is applied with the use of the manual aneroid sphygmomanometer fixed at 100 millimeters of mercury. Brand QUIRUMED with CE Marking 0197. A pressure lower than the systolic blood pressure, and in each subject will be monitored the radial pulse."
15851941|NCT04027205|Other|Physiotherapist-led exercise|A programme of physiotherapist-led exercise over approximately 12 weeks.
15851942|NCT04027205|Procedure|Surgical repair|Surgical repair of the rotator cuff plus usual post-operative rehabilitation
15851943|NCT04027192|Drug|BAY2328065 LSF|20 mg/mL LSF (liquid service formulation), orally
15851944|NCT04027192|Drug|BAY2328065 tablet|50 mg tablet, orally
15851945|NCT04027192|Drug|Placebo LSF|Matching Placebo LSF, orally
15851946|NCT04027192|Drug|Placebo tablet|Matching Placebo tablet, orally
15851947|NCT04027192|Drug|Midazolam|1 mg per day, orally
15851956|NCT04027114|Behavioral|Individualized behavioural physical activity intervention|• The intervention involves a tailored physiotherapy (PT) intake that will serve as the foundation for the individualized approach. Participants' individual attributes and physical activity needs, including a general PT assessment will occur initially. Over the next 12 months, participants will receive individualized PT coaching and a physical activity plan plus access to educational literature that outlines methods and benefits of exercise. An estimated 15 hours of PT contact hours per participant is anticipated and the specifics of each encounter will be documented.
15851957|NCT04027101|Drug|Baricitinib|patient will take a tablet of 4 mg/d during 12 weeks and then 2 mg/d during 12 weeks if the patient achieves PMR-AS≤ 10 at week 12
15851958|NCT04027101|Drug|Placebos|patient will take a tablet of 4 mg/d during 12 weeks and then 2 mg/d during 12 weeks if the patient achieves PMR-AS≤ 10 at week 12
15851959|NCT04027088|Dietary Supplement|Immunonutrition|It is a hypercaloric and hyperproteic dietary supplement formulated with immunonutrients: Arginin, nucleotides, omega-3, olive oil polyphenols, antioxidants and L-carnitine
15851960|NCT04027088|Dietary Supplement|Standard|It is a hypercaloric and hyperproteic dietary supplement formulated without immunonutrients
15851961|NCT04027075|Behavioral|Rewire app users|Use of the Rewire app involves completing 12 modules and 12 practice sessions over 30 days.
15851962|NCT04027062|Behavioral|Diabetes Continuing Education Intervention|"The program will follow the International Curriculum for Diabetes Health Professional Education, which developed by the International Diabetes Federation (IFD) The key components of the proposed program content are Diabetes presentation and complications, Lifestyle, Nutrition, and Fitness.
~the intervention will be carried out by group of Diabetes educators from a different discipline, such as an Endocrinologist, Family physician, the dietitian will teach the attended physicians."
15851963|NCT04027049|Device|Supine cycle ergometry of the lower extremities|The cycle ergometer allows for movement of the lower extremities by a motor if a patient is experiencing a disorder of consciousness or is otherwise unable to move one or both legs. If a patient is able to cycle actively the device allows the patient to move patient's legs without support of the motor.
15851964|NCT04027036|Biological|Inactivated poliovirus vaccine in reduced doses|"contains the following excipients: 2-phenoxyethanol (2.5 mg), water for injection and diluent solution and phosphate buffer having the following composition: sodium phosphate, sodium chloride, potassium chloride, magnesium sulfate, phenol red and calcium chloride.
~dosage:0,1ml duration: first dose: month 2 of age; second dose: month 4 of age"
15851965|NCT04027023|Drug|Diabetes mellitus Type 2 De-escalation treatment (DET)|"All employed drugs are approved in the US for treatment of type 2 diabetes and are used within their label. There will be defined individual treatment drug combinations at an earlier stage of diabetes as in standard treatment. The DET combination will be composed out of one each or more of the drugs and interventions listed below.
~A. Relieve for the insulin-producing ß-cells insulin glargine (6 to 20 U at bedtime) insulin degludec (5 to 15 U at bedtime) B. Reduction of hormonal visceral lipid tissue activity/chronic inflammation Weight loss liraglutide (0.6 mg/day) exenatide (15 µg/day) C. Treatment of metabolic and vascular insulin resistance Pioglitazone (30 mg) D. Treatment of glucose toxicity Empagliflozin (SGLT-II inhibitor; 10 mg) Dapagliflozin (SGLTII-Inhibitor, 10 mg) Canagliflozin (SGLT-II inhibitor, 100 mg) Metformin (inhibition of hepatic glucose production, 500 mg)
~To avoid hypos, all drugs are initially given in the lowest possible dose."
15851966|NCT04027010|Other|"Healthy U tablet application"|"There are seven modules in Healthy U: Puberty, Birth Control, Teen Pregnancy, HIV, STDs, Healthy Relationships, and Condom Negotiation. Each module has six sections: Introduction and Review, Narrative Teen Portrait, Information Film, Activity/Game, Dramatic Film, and Imagination Challenge. The Introduction and Review has videos lasting 1-2 minutes where the Healthy U host introduces each module. In the Narrative Teen Portrait for each module, a different teen discusses their experience with the topic for 1-3 minutes. The Information Film lasts 5-18 minutes per module and provides factual information. For each module, the Activity/Game includes multiple choice, true/false, or other games. The Dramatic Film lasts 5-17 minutes for each module and shows a fictional account of a teen experiencing the topic. Finally, the Imagination Challenge asks the youth to imagine a scenario, such as going to a health clinic to obtain free condoms."
15851967|NCT04026997|Drug|CIN-102 Dose 1|CIN-102 Dose 1
15851968|NCT04026997|Drug|CIN-102 Dose 2|CIN-102 Dose 2
15851969|NCT04026997|Drug|CIN-102 Dose 3|CIN-102 Dose 3
15851970|NCT04026997|Drug|Placebo|Placebo
15851971|NCT04026984|Drug|Rifamycin SV-MMX|2 Rifamycin SV-MMX® 50 mg tablets b.i.d. plus ORT
15851972|NCT04026984|Drug|Placebo|Matching Placebo tablets
15851973|NCT04026971|Procedure|This study is a randomized controlled study aiming to evaluate the effect of phone application supported nutrition education on weight loss according to standard education.|This study is a randomized controlled study aiming to evaluate the effect of phone application supported nutrition education on weight loss according to standard education.
15851974|NCT04026958|Drug|Clarithromycin|Clarithromycin will be dosed as 500 mg twice daily, once upon awakening and once with lunch, for 14 days.
15851975|NCT04026958|Drug|Placebo|A placebo to match clarithromycin will be dosed as 500 mg twice daily, once upon awakening and once with lunch, for 14 days.
15851976|NCT04026945|Drug|Lidocaine|Sustained-release lidocaine injection
15851977|NCT04026932|Other|Listening to unmodified music|Listening to unmodified music for at least 2 hours a day
15851978|NCT04026932|Other|Listening to modified tinnitus relieving sound|Listening to modified tinnitus relieving sound for at least 2 hours a day
15851979|NCT04026919|Other|OK EN CASA-ZAINDOO|Intervention based on cognitive- behavioural techniques offered in an online format.
15851980|NCT04026906|Device|Cyanoacrylate glue|One drop of cyanoacrylate glue will be applied to the intravenous (IV) insertion site and another drop under the hub of the IV catheter
15851981|NCT04026906|Other|Transparent polyurethane dressing|The IV will be secured in the usual manner with tape and a transparent dressing.
15852008|NCT04026646|Procedure|Proprioceptive Neuromuscular Facilitation stretching exercise|Proprioceptive Neuromuscular Facilitation stretching exercises (contract-relax-antagonist-contract method) will be performed 6 repetition and totally 30 seconds stretching for hamstring muscle group will be performed.It will be applied 3 days in a week for 8 week.
15852009|NCT04026646|Procedure|Static stretching exercise|Static stretching exercises will be applied 2 repetition. Totally 30 seconds stretching for hamstring muscle group will be performed. It will be applied 3 days in a week for 8 week.
15851982|NCT04026893|Procedure|Uterine Transplant from Deceased Donor|The recipient will be started on anti-rejection medications (as is routine for transplant recipients) prior to the OR. Standard of care anesthesia and line placement will take place. The recipient will be appropriately identified as an organ recipient and the donor organ identified per required transplant protocols already in place. The recipient team will then connect the vasculature and appropriate supporting structures for the uterus transplant. Once the organ has been re-perfused, the remainder of the operation will take place and the patient will be moved to the Intensive Care Unit and later to the transplant patient floor for standard monitoring.
15851983|NCT04026880|Drug|Testosterone Enanthate|25 mg testosterone enanthate administered by intramuscular injection weekly for 12 weeks
15851984|NCT04026880|Drug|Placebo|Placebo administered by intramuscular injection weekly for 12 weeks
15851985|NCT04026867|Other|Linkage Navigation|The Linkage Navigation arm will consist of an additional service layered onto clinician referral and will incorporate protocols from Antiretroviral Treatment and Access Studies (ARTAS), the most influential studies of HIV linkage-to-care to date.
15851986|NCT04026867|Other|Clinician Referral|"The Clinician Referral arm will serve as an active control and baseline standard of care."
15851987|NCT04026854|Behavioral|Quality of live at work|The judging criteria will be collected using two questionnaires: a questionnaire sent to the local referent of each center and a questionnaire for each nurse. Because the study is longitudinal (two collections of data), the questionnaires will be completed twice to twelve months apart by the same nurses.
15851988|NCT04026841|Drug|PD-1 antibody Sintilimab|Patients in experimental group receive the treatment of PD-1 antibody Sintilimab
15851989|NCT04026828|Genetic|Periodontitis Group|Periodontitis group consists of both chronic and aggressive periodontitis patients
15851990|NCT04026815|Other|medical history, blood and urine tests|The study protocol consists of questionnaires (medical, socio-economic, dietary), comprehensive geriatric assessment, physical examination, anthropometric and blood pressure measurements and laboratory tests.
15851991|NCT04026802|Other|In-Bed Resistance Training Device|Physical Therapy using the in bed training device
15851992|NCT04026802|Other|Standard of Care|Does not include early implementation of physical therapy
15851993|NCT04026789|Other|Same-day-start|Patients seeking medication abortion who are shown to have an asymptomatic, low-risk pregnancy of unknown location who are randomized to same-day start will have their medication abortion initiated on the day that they present for services while simultaneously ruling out ectopic pregnancy with serial hcg testing
15851994|NCT04026789|Other|Delay-for-diagnosis|Patients seeking medication abortion who are shown to have an asymptomatic, low-risk pregnancy of unknown location who are randomized to delay-for-diagnosis will first have ectopic pregnancy ruled out with serial hcg and ultrasounds prior to initiating medication abortion
15851995|NCT04026776|Drug|Allopurinol|Study Part 2- Preterm group only: After Visit 5 preterm born participants will start allopurinol 200 mg daily PO for 6 weeks. The 1 week high and low salt diets and assessments will be repeated while on allopurinol.
15851996|NCT04026776|Other|Dietary Intervention|High-Na+ (250 mmol/d) and low-Na+ (50 mmol/d) standard isocaloric K+ diets (75 mmol/1000 kcal/d) for 1 week each as 3 meals and 1 snack a day provided by the Clinical Research Unit Metabolic Kitchen. Part 2 preterm only- the diets will be repeated while the participant is taking allopurinol.
15851997|NCT04026763|Procedure|prostate biopsy|standard of care
15851998|NCT04026763|Procedure|MR US Fusion Guided Prostate Biopsy|Trans-rectal ultrasound (TRUS) guided fusion prostate biopsy, Transperineal Ultrasound guided fusion prostate biopsy
15851999|NCT04026763|Device|MR/TRUS Fusion Guided Prostate Biopsy|TRUS images are overlaid on a previously obtained prostate MRI, combined with an electromagnetic tracking system. The urologist then performs directed prostate biopsies at MR-identified targets in addition to the standard prostate biopsies.
15852000|NCT04026750|Drug|Pitolisant|Pitolisant will be administered orally for 7 days. Patients may have their study drug dose adjusted downward if the starting dose is not tolerated.
15852001|NCT04026724|Drug|Chinese patent medicine|Shexiang Baoxin Pill, Tongxinluo Capsule, Tongmai Yangxin Pill, Xuefu Zhuyu Capsule, Qishen Yiqi Dropping Pill.
15852002|NCT04026711|Drug|Mitoquinol|Mitoquinol (MitoQ) 40 mg per day for 12 weeks
15852003|NCT04026711|Drug|Placebo oral tablet|Placebo daily for 12 weeks
15852004|NCT04026698|Behavioral|Resident and Family Engagement Intervention|"The leadership coaching component targets managers, administrators/ directors of care in long-term care settings. These sessions involve selecting a subset of relevant performance outcomes from the quality improvement plan that align with leadership vision and priorities for staff performance which leaders can monitor, reinforce and encourage.
~The education component involves a one-day in-person training session for staff and managers on communication strategies and ways to engage family and residents in care planning, and includes follow-up visits.
~The huddle component involves a series of resident and family led huddles (brief, 15 minute meetings) to discuss something important with staff to foster proactive communication and information sharing. Resident-family dyads will participate in the huddles, along with the staff and management team who received the training. The huddles will be scheduled for 15 minutes once/month for 6 months."
15852005|NCT04026685|Drug|Phenylephrine infusion|continuous phenylephrine infusion started at a rate of 25mcg/min and titrated according to blood pressure
15852006|NCT04026685|Drug|Phenylephrine infusion and Ringer-Acetate bolus|continuous phenylephrine infusion started at a rate of 25mcg/min and titrated according to blood pressure plus crystalloid Ringer-Acetate co-loading bolus of 1000 mL
15852007|NCT04026659|Other|Multi-modal exercise|A combination of aerobic, resistance, balance and flexibility exercises will be included. Aerobic exercise will consist of 20 to 30 min of moderate intensity exercise using a variety of modalities. Heart rate will be monitored using Polar hear rate monitors (target intensity 40-70% heart rate reserve) and the BORG Rating of Perceived Exertion (12-15). Resistance exercise will target the large muscle groups of the upper and lower extremities, be performed at 40% to 70% of the one repetition maximum (1-RM) and consist of two sets of 10-15 repetitions. Flexibility and balance exercise will also be included in the twice weekly programme. A home exercise programme will encourage participants to be moderately physically active for at least 30 minutes, three times per week in addition to the supervised programme.
15852010|NCT04026633|Behavioral|CAA|Participants will write about the use of PBS and alcohol use.
15852011|NCT04026633|Behavioral|Control|Participants will write about eating and exercise.
15852012|NCT04026620|Behavioral|Informational Pamphlet|The control group will be provided with two (2) informational pamphlets (and have it read to those who are of lower literacy). Pamphlets contain information about the harmful effects of drinking alcohol during pregnancy and the harmful effects of alcohol on the unborn baby.
15852013|NCT04026620|Behavioral|Brief Motivational Enhancement Therapy (MET) Session|The case control trial/efficacy study will provide a one-session MET session in Afrikaans (the predominant language of the region). The face-to-face session will provide information to help people and pregnant women who want to change their drinking behavior, become 'dry' and stay motivated to change their drinking behaviors. Sessions will be approximately one (1) hour and 30 minutes.
15852014|NCT04026607|Dietary Supplement|Protein Supplementation|Participants will continue to ingest the standardized diet; however, supplements will be consumed twice daily (25g per serving x 2 servings/day or 50g supplemental protein/day)
15852015|NCT04026594|Other|Mindfulness Based Stress Reduction|"MBSR teaches mindfulness meditation and mindful yoga exercises to develop non-judgmental awareness of moment-to-moment experience. The intervention duration is 8 weeks, with weekly two and half hours sessions. It will be delivered according to the fundamental concepts and specific techniques provided in the MBSR manualized protocol by Kabat-Zinn. The program also includes 30-min daily homework exercises.
~MBSR teaches four main mindfulness practices: (1) body scan, a process of moving attention through the body; (2) mindful movement, consisting of gentle yoga stretches to develop awareness of body in movement; (3) sitting meditation; and (4) walking meditation. Inquiry and didactic teaching is also a part of MBSR and allows for some detailed exploration of participants' experiences."
15852016|NCT04026594|Other|Relaxation group|control group
15852017|NCT04026581|Behavioral|Speech generating device (SGD) evaluation including BCI access|At the initial evaluation the participants will review the full range of AAC options and speech generating devices (SGDs) and complete a speech and language evaluation. The second evaluation date will involve a trial of SGDs matched to the participant's assessment results. The third visit is the trial of an AAC system with BCI access. Should the dry electrode headgear for BCI access prove ineffective, then the gel electrode cap will be offered to the participant for trial. At the end of the third visit, the evaluation results will be discussed with participant and family, and they will be asked to select the preferred SGD.
15852018|NCT04026581|Behavioral|Training and treatment|Participants receive training on the selected SGD followed by monthly treatment sessions from the SLP who monitors performance. In some cases the participants' SGD will be an AAC system with BCI access. In this case training will also include an identified system support person. Use of the SGD is monitored on a monthly basis through home visits and/or tele-practice sessions, when requested. Technical support for the SGD is provided on an as needed basis or when requested by the participant or support person.
15852019|NCT04026568|Drug|4-Aminopyridine|Single drug test for nerve continuity
15852020|NCT04026568|Drug|Placebo oral tablet|Placebo arm
15852021|NCT04026555|Other|MEWS++ Monitoring|Patient's electronic medical record data will undergo processing by a machine learning algorithm (MEWS++).
15852022|NCT04026555|Other|Predictor Score|A score predicting the likelihood that the patient will experience a deterioration in their clinical condition within six hours will be generated. If the prediction score exceeds a predetermined threshold, an alert will be sent to the provider. The alerting protocol is tiered, with both a low and high threshold. If the score is above the low threshold, nursing will be notified. If the score is above the high threshold, RRT will be notified.
15852023|NCT04026529|Other|walking on incline or walking at increasing speed|"Subjects will be prepared for data collection by wearing a form-fitting suit (i.e., wrestling singlet) and obtaining height and body weight. Retro-reflective markers will be placed bilaterally on anatomical locations of the feet, legs, and hips.
~be outfitted with the portable metabolic cart and oximeter as in the previous visit. One of two treadmill trials will be performed: 1) at the speed and 2) at the slope +speed determined in the previous visit. Trial order will be randomized among subjects and across visits 3 & 4. For each trial, subjects will be asked to walk on a treadmill for up to 6 minutes. Speed or slope will be increased every 30 seconds and they will be asked to walk for one minute at that speed or"
15852024|NCT04026516|Device|CAVA Device|The CAVA device will be worn continuously for thirty days, during which time it will record eye and head movements
15852025|NCT04026503|Other|Live Long Walk Strong rehabilitation program|Live Long Walk Strong is a rehabilitation program that focuses on impairments known to contribute to mobility decline that are not considered standard of care in rehab and addresses behavioral change within the context of rehabilitation.
15852026|NCT04026490|Behavioral|Immediate Intervention|The Interventionist will use motivational interviewing skills, assess ethnic and racial microaggressions, and provide support, screen for posttraumatic stress, and, if appropriate, link student to advanced care. The student may meet with the Interventionist several times during the remainder of the school year. These meetings will be approximately 10-30 minutes in length and occur during the school day in a private location determined by the Interventionist. The student may be referred to additional resources as a result of the meetings. The meetings will be documented by the Interventionist using a case management system (in RedCap).
15852027|NCT04026490|Behavioral|Waitlist Intervention|In order to compare outcomes contemporaneously, students from waitlisted schools will be asked to complete baseline and follow-up surveys, which will be collected at approximately the same time as in the immediate intervention schools. The data will be captured for analysis at the end of the study. Students will complete intervention following the waitlist period.
15852028|NCT04026477|Behavioral|Immediate Universal Trauma-Informed Care and Cultural Humility Training|Instructional video and workshop
15852029|NCT04026477|Behavioral|Waitlisted Universal Trauma-Informed Care and Cultural Humility Training|Instructional video and workshop following waitlist period
15852030|NCT04026464|Drug|Intravenous Ibuprofen|The control monotherapy group will receive 10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently.
15852031|NCT04026464|Drug|Intravenous Ibuprofen + Oral Acetaminophen|The combined treatment group will receive 10 mg/kg intravenous ibuprofen followed by 5 mg/kg 24 and 48 hours subsequently and will in addition receive 15 mg/kg oral acetaminophen [160 mg/5ml concentration] every 6 hours for a total of 12 doses.
15852068|NCT04026178|Drug|Metreleptin|Subjects will receive prescribed dosage of metreleptin as indicated in the USPI
15852069|NCT04026165|Drug|SEL|Tablet administered orally once daily
15852070|NCT04026165|Drug|Placebo|Tablet administered orally once daily
15852032|NCT04026451|Device|Sedation guided by SEF95 (10-13 Hz) from SedLine® monitor|Dosage of propofol and fentanyl will be guided by SEF95 value between 10-13 Hz. If SEF95 is lower than 10 Hz, the infusion rate of propofol and fentanyl will be diminished; if SEF95 is higher than 13 Hz, the infusion rate of propofol and fentanyl will be increased; and if SEF95 is between 10-13 Hz, then the infusion rate will be kept.
15852033|NCT04026451|Behavioral|Sedation guided by SAS scale (1-2)|Dosage of propofol and fentanyl will be guided by SAS to keep a value of 1-2. If SAS is higher than 1-2, then the infusion rate of propofol and fentanyl will be increased; and if SAS is 1-2, then the infusion rate of propofol and fentanyl will be maintained.
15852034|NCT04026451|Drug|Deep sedation with propofol andfentanyl|Propofol and fentanyl will be infused to reach a score in the SAS of 1-2
15852035|NCT04026451|Procedure|Mechanical Ventilation|Critically ill patients will be ventilated mechanically following the clinical indication.
15852036|NCT04026438|Drug|Potassium Phosphate Injection|One ml of the preparation contains 3 mmol of phosphorous which when equated with RDA 10ml ie 30 mmol of preparation will be supplemented. The preparation is given slowly, intravenously over 4 hours diluted in 500 ml normal saline
15852037|NCT04026425|Other|Two-day cardiopulmonary exercise test|A series of two cardiopulmonary exercise tests (CPETs) performed over two days. Participants will perform a CPET and then will return approximately 24 hours later to perform the second CPET. The CPET begins with 3 minutes of seated rest followed by cycling during incremental workloads which increases 15 watts throughout each minute of exercise. The participant will cycle until volitional exhaustion and/or the participant and/or test administrator determines to stop the test. Actual exercise time usually varies between 8-10 minutes.
15852038|NCT04026412|Biological|nivolumab|Specified dose on specified days
15852039|NCT04026412|Biological|ipilimumab|Specified dose on specified days
15852040|NCT04026412|Biological|durvalumab|Specified dose on specified days
15852041|NCT04026399|Other|peripheral vibration stimulation|wearing a wristband that delivers imperceptible vibratory stimulation.
15852042|NCT04026399|Behavioral|therapy|practice of daily living tasks
15852043|NCT04026386|Behavioral|Center Based Early Intervention Program|This is a 12-week early intervention program that will include 12 weekly hours of treatment in an intensive center-based preschool environment to treat social communication deficits in children with developmental disorders.
15852044|NCT04026373|Behavioral|modified Prolonged Exposure|
15852045|NCT04026373|Behavioral|Treatment as usual|May include consult to health psychology and any follow-up deemed appropriate
15852046|NCT04026360|Other|no intervention|
15852047|NCT04026347|Device|Vesair Balloon|Indwelling, intravesical balloon
15852048|NCT04026347|Other|Sham balloon placement|Sham balloon placement procedure
15852049|NCT04026334|Device|V.A.C. VERAFLO CLEANSE CHOICE™ dressing with Normal Saline|-125mmHg, 10 minute soak time, 3.5 hours of negative pressure therapy
15852050|NCT04026321|Drug|SQ001 125mL/day|SQ001 125mL/day will be administered by intravenous route at a rate of 3 mL/minute
15852051|NCT04026321|Drug|SQ001 250mL/day|SQ001 250mL/day will be administered by intravenous route at a rate of 3 mL/minute
15852052|NCT04026321|Drug|SQ001 500mL/day|SQ001 500mL/day will be administered by intravenous route at a rate of 3 mL/minute
15852053|NCT04026321|Drug|SQ001 625mL/day|SQ001 625mL/day will be administered by intravenous route at a rate of 3 mL/minute
15852054|NCT04026321|Drug|Saline 0.9%|Saline 0.9% will be administered by intravenous route at a rate of 3 mL/minute
15852055|NCT04026308|Other|Safety Net App|The Safety Net app is an electronic version of a safety plan and it is available for download in Apple's App Store. A preview of the app is available at: https://apps.apple.com/us/app/stanley-brown-safety-plan/id695122998. This app is owned by Two Penguins Studios, LLC. It was developed in partnership with the New York State Office of Mental Health. Unlike the paper version, the Safety Net app allows participants to email a copy of their safety plan to whomever they wish. It also allows patients to dial 911 or the National Suicide Prevention Lifeline from the app.
15852056|NCT04026295|Behavioral|Short Burst Interval Treadmill Training (SBLTT)|SBLTT will consist of short-bursts (30 seconds) of high speed walking alternating with 30 seconds of low/moderate speed walking. Total duration of walking per session will be up to 30 minutes of the 30 second alternating intervals (30sec high / 30sec low/moderate) with rests as needed. Both groups will receive 40 sessions delivered 5x/week for 8 weeks. Initial speeds for high speed walking will be 75-80% of each participant's over ground baseline fast walking speed, and low/moderate speed will be 75-80% of self-selected speed calculated from the 10-Meter Walk Test.
15852057|NCT04026295|Behavioral|Traditional Locomotor Treadmill Training (TLTT)|TLTT group will receive the same number of sessions (40) delivered 5x/week for 8 weeks with a total duration of walking per session up to 30 minutes with rests as needed. TLTT will consist of walking at steady-state speeds. Initial treadmill speed will be 75-80% of over ground self-selected walking speed. The overall goal will be to achieve 30 minutes of walking at a steady-state walking speed within each session. Speed will be increased on the next session by .1 to .4mph when the subject can walk for 30 minutes on the treadmill at the current speed with an OMNI score of < 6/10.
15852058|NCT04026282|Procedure|GnRH-ant protocol|Recombinant FSH (Gonal-f®) will be administrated as routinely practiced by investigators. FSH doses will be adjusted according to the clinical experiences of investigators.The GnRH-ant (Cetrotide®) will be initiated in a fixed protocol on stimulation days 5 or 6 per the investigator's ART protocol.
15852059|NCT04026282|Procedure|GnRH-a long protocol|The GnRH-a (Diphereline® or Decapetyl®) 0.1mg will be administered for about14 to 20 days for down-regulation. Gonal-f® will be administrated as routinely practiced by investigators. GnRH-a types, GnRH-a and FSH doses will be adjusted according to the clinical experiences of investigators in each site.
15852060|NCT04026269|Drug|MOAP|the new chemotherapy regimen for r/r cHL
15852061|NCT04026256|Drug|Teriparatide|teriparatide daily subcutaneous injection
15852062|NCT04026256|Drug|Denosumab|denosumab subcutaneous injection
15852063|NCT04026243|Procedure|QL block|U/S guided Transmuscular Quadratus Lumborum Block
15852064|NCT04026243|Procedure|TF block|U/S guided Transversalis Fascia Plane Block
15852065|NCT04026230|Drug|Atorvastatin 80mg|Capsules including 80 mg of atorvastatin
15852066|NCT04026230|Drug|Placebo oral capsule|Similar capsules as in the atorvastatin arm, but without the active ingredient
15852067|NCT04026191|Device|OrthoVisc®-T (OVT)|Sodium hyaluronate supplied as a 2 mL (15mg/mL) unit dose in a 3 mL glass syringe.
15852071|NCT04026152|Behavioral|Resistance training|Following randomization, all participants assigned to receive the resistance training intervention will receive a comprehensive exercise program. The exercise program participants will be using is similar to past research using resistance training programs with people with anxiety-related disorders and has been developed and reviewed by a team of certified personal trainers, including the primary investigator. All participants assigned receive this resistance training intervention will complete a total of six sessions with a personal trainer and six session independently over four weeks to allow for a gradual, rather than abrupt, transition to fully independently completed exercise by the 4th week. After this time participants will be encouraged to exercise independently.
15852072|NCT04026152|Behavioral|Unified Protocol|This intervention consists four weekly sessions adapted from the Unified Protocol. The first module is Psychoeducation and Motivational Interviewing. During this module, participants will develop an understanding of their own pattern of emotional responding to exercise as well as increasing participants' readiness and motivation for behaviour change.The second module is Cognitive Flexibility, during which participants will learn about how automatic negative interpretations can influence their emotional reactions and prevent them from considering alternative explanations. The third module is Countering Emotion-Driven Behaviours during which participants will identify and counter behaviours used to dampen strong emotions, particularly those associated with exercise. Lastly, module four will use Exposure to external and internal emotional triggers to increase participants' tolerance to the emotions that arise in exercise environments.
15852073|NCT04026139|Other|Elastic Band Resistance Exercise|Patients in the experimental and control group were instructed by clinical staff to perform home-based exercises and followed up through phone calls. The experimental group performed exercises using an elastic resistance band with 10 repetitions/set × 5 sets/day × 3 days/week.
15852074|NCT04026139|Other|active joint range-of-motion exercises and isometric contraction exercises|The control group underwent active joint range-of-motion exercises and isometric contraction exercises. The intervention regimens lasted 12 weeks.
15852075|NCT04026126|Behavioral|Heat Therapy Treatment|Subjects will undergo 10 hot water immersions of 40.5 degrees Celsius for approximately 45 minutes per session over 14 days. Subjects will be immersed up to the shoulder until rectal temperature reacher 38.5 degrees Celsius (approximately 15-20 minutes). Subjects will then remain in the water bath submerged at waist level to maintain between 38.5 to 39.0 degrees Celsius for another 30 minutes. Following hot water immersion, subjects will be monitored for 10 minutes, or until temperature falls below 38.5 degrees Celsius.
15852080|NCT04026100|Biological|CTA101|Universal CD19-directed CAR-T cells by a single infusion intravenously will be given in escalating doses. Subjects will been distributed into low dose (0.2×10^6), medium dose (2×10^6), and high dose (3×10^6).
15852081|NCT04026074|Drug|Fentanyl|Weight adapted drug application
15852082|NCT04026074|Drug|Remifentanil|Weight adapted drug application
15852083|NCT04026074|Drug|Clonidine|Weight adapted drug application
15852084|NCT04026074|Drug|EMLA Cream|Salve application on the body part where the regional anaesthesia will be administered
15852085|NCT04026074|Drug|Placebo iv|i.v. administration of 0,9% NaCl
15852086|NCT04026074|Drug|Placebo salve|Skin protection salve (placebo salve) application on the body part where the regional anaesthesia will be administered
15852087|NCT04026061|Behavioral|FMA group|A person-centred, tailored tablet intervention, called FindMyApps (FMA). The intervention consists of the FMA training to use the tablet and the FMA selection tool to help users find apps for self-management and meaningful activities that fit their needs, wishes and abilities
15852088|NCT04026061|Behavioral|Control group|Receiving an introductory tablet training and some links to websites that recommend usable apps for people with dementia in general
15852089|NCT04026048|Behavioral|Cognitive Behaviour Therapy for Insomnia (CBT-I)|CBT-I is a manualized multi-component intervention that includes sleep restriction, stimulus control, cognitive restructuring, relaxation training, and sleep hygiene.
15852090|NCT04026022|Drug|Fentanyl Transdermal System|Patients will be treated perioperatively with a new pain management, that has been modified to integrate the 2017 ESA guidelines on prevention/treatment of postoperative delirium. Moreover patients will be administered a 12µg/h Fentanyl TTS in the ER or PACU. The ER TTS will only be administered if the patients still has mild to intense pain after initial intravenous (i.v.) treatment as well as reposition of the fractured hip. Further aspects of the modified management are: avoiding benzodiazepines, allowing oral fluids up to 2 hours before surgery, intraoperative monitoring of anaesthesia depth and at least 1,8 ltr crystalloid infusion per day.
15852091|NCT04026022|Drug|Placebo|Placebo plaster in the ER or PACU
15852092|NCT04026009|Biological|C. difficile investigational vaccine based on the F2 antigen (GSK2904545A)|"Subjects in CDIFF Ag 18 - 45 Years and CDIFF Ag 50 - 70 Years Groups will receive 2 or 3 doses (0.5 mL each) of CDIFF Ag vaccine.
~The vaccine will be administered intramuscularly in the deltoid, at a 0, 1-month dose interval. The third dose will be administered approximately 15 months after the second dose."
15852093|NCT04026009|Biological|C. difficile investigational vaccine based on the F2 antigen (GSK2904545A) adjuvanted with AS01B|"Subjects in CDIFF Ag + AS01B 50 - 70 Years Group will receive 2 or 3 doses (0.5 mL each) of CDIFF Ag + AS01B vaccine.
~The vaccine will be administered intramuscularly in the deltoid, at a 0, 1-month dose interval. The third dose will be administered approximately 15 months after the second dose."
15852094|NCT04026009|Drug|Placebo|Subjects will receive 2 doses (0.5 mL each) of Placebo, administered intramuscularly in the deltoid, at a 0, 1-month dose interval.
15852095|NCT04025996|Diagnostic Test|Cardiac Assessments and Eye Assessments|"Cardiac Assessments, include the following:
~transthoracic echocardiography
~computed tomography of coronary arteries
~position emission tomography computed tomography or single photon emission tomography computed tomography
~Eye examinations, include the following:
~pupil dilation
~retinal photography
~dynamic vessel analyser
~IOL master"
15989666|NCT02965872|Other|No intervention|
15852098|NCT04025970|Genetic|Circulating tumor cell and circulating tumor DNA test|Patient stratification based on presence or absence of suspicious findings of cells and DNA
15852099|NCT04025957|Drug|SHR-1501|Administered subcutaneously
15852100|NCT04025931|Drug|chidamide and toripalimab|"The eligible patients with advanced soft tissue sarcoma were treated with chidamide combined with toripalimb. Chidamide 30mg orally twice a week;
~Toripalimab 240 mg (fixed dose) every three weeks.
~Repeat every three weeks. Patients with disease control (CR + PR + SD) and tolerable adverse reactions continued to take medication until the researchers concluded that patients were not suitable to continue medication or the efficacy evaluation was disease progression (PD). No other antineoplastic treatment can be given during the treatment."
15852101|NCT04025918|Device|Vasopressor automated delivery system|"Novel closed-loop system incorporating:
~Continuous non-invasive arterial pressure (CNAP) monitor that measured and recorded hemodynamic data in real time.
~Controller algorithm loaded onto a laptop computer that monitored the hemodynamic data from CNAP and determined if vasopressors should be administered.
~Two syringe pumps loaded with phenylephrine and ephedrine that was activated by the controller algorithm."
15852102|NCT04025918|Drug|Phenylephrine|Phenylephrine is a vasopressor drug that was administered when the participant's systolic blood pressure fell below 90% of baseline systolic blood pressure, with heart rate of at least 60bpm.
15852103|NCT04025918|Drug|Ephedrine|Ephedrine is a vasopressor drug that was administered when the participant's systolic blood pressure fell below 90% of baseline systolic blood pressure, with heart rate of less than 60bpm.
15852104|NCT04025918|Device|Manual vasopressor delivery system|"Manual dosing system consisting:
~Non-invasive intermittent blood pressure monitor that measured and recorded blood pressure at 1-minute intervals.
~Attending anesthesiologist that noted the blood pressure readings and manually administered phenylephrine or ephedrine according to the algorithm."
15852105|NCT04025905|Behavioral|Social Cognition Training|Evaluate the impact of the social cognition training on employment maintaining in transitional Workforce Assistance Facilities and Services.
15852106|NCT04025905|Behavioral|Informations|informations about work environment, social environment, stress management, sleep management, treatments
15852107|NCT04025892|Behavioral|Daily weighing|Participants will be asked to use the scale to track their body weight daily at home for six weeks. They will receive a weekly email contact with weight change feedback and either a nutrition or physical activity tip for the week. The study procedures represent minimal risks, and participants will be reminded and encouraged to maintain their regular prenatal care contacts with their provider.
15852108|NCT04025879|Biological|Nivolumab|Specified dose on specified days
15852109|NCT04025879|Drug|Carboplatin|Specified dose on specified days
15852110|NCT04025879|Drug|Cisplatin|Specified dose on specified days
15852111|NCT04025879|Drug|Paclitaxel|Specified dose on specified days
15852112|NCT04025879|Drug|Pemetrexed|Specified dose on specified days
15852113|NCT04025879|Drug|Placebo|Specified dose on specified days
15852114|NCT04025879|Drug|Docetaxel|Specified dose on specified days
15852115|NCT04025866|Other|Conventional rehabilitation|1h/day for 5 days/week of conventional rehabilitation for femur fracture
15852116|NCT04025866|Other|Aerobic exercise|30 min/day of aerobic exercise with arm cycle ergometer added to 1h/day for 5 days/week of conventional rehabilitation for femur fracture
15852117|NCT04025840|Other|Epidural block|Epidural block (with 0.375% ropivacaine) is performed during surgery. Patient-controlled epidural analgesia (with a mixture of 0.12% ropivacaine and 0.5 microgram/ml sufentanyl) is provided after surgery.
15852118|NCT04025840|Drug|Dexamethasone|Dexamethasone (10 mg) is administered intravenously before anesthesia induction.
15852119|NCT04025827|Other|Dietary intake|We will collect detailed data on dietary intake and weight for healthy newborns in four low income countries.
15852120|NCT04025814|Device|CaregiverAssist|CaregiverAssist is a proposed dHealth tool to promote parent adherence and sustained strategy use of evidence-based parenting strategies.
15852121|NCT04025788|Device|Magmaris Resorbable Magnesium Scaffold (RMS)|Subjects will undergo a percutaneous coronary intervention for the implantation of the Magmaris scaffold in accordance with the standard of care and standard hospital practice. Maximum of two single de novo lesions in two separate major epicardial vessels are allowed.
15852122|NCT04025775|Device|CamAPS HX Closed-loop|"The CamAPS HX closed-loop system comprises
~Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
~Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
~An Android smartphone hosting CamAPS HX Application with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump
~Glooko/Diasend cloud upload system to monitor CGM/insulin data."
15852123|NCT04025775|Other|Multiple Daily Insulin Injections (Control)|Multiple Daily Insulin Injections with masked Dexcom G6 CGM sensor (Dexcom, Northridge, CA, USA)
15852124|NCT04025762|Device|Hybrid closed-loop system (CamAPS FX)|Hybrid closed-loop system
15852125|NCT04025762|Device|Sensor augmented pump therapy|Sensor augmented pump therapy
15852126|NCT04025749|Behavioral|Computerized Executive Functions training|Home-based executive function training with adaptive difficulty, through NeuronUp (https://www.neuronup.com) over 12 weeks (30 min/day, 5 days per week, 30h in total).
15852127|NCT04025749|Other|Care as usual|Care as usual
15852128|NCT04025736|Drug|Tranexamic Acid 100Mg/Ml Inj Vil 10Ml|Tranexamic acid (TXA) is a synthetic analog of the amino acid lysine which acts by competitively blocking the plasminogen lysine-binding site and inhibiting fibrinolysis. Several studies showed that TXA could reduce both blood loss and the amount of blood transfusion after shoulder arthroplasty surgeries.
15852129|NCT04025736|Drug|0.9% Sodium Chloride Injection|Normal saline is a mixture of sodium chloride in water and has a number of uses in medicine. We use the same volume of normal saline as placebo.
15852130|NCT04025723|Other|Downhill running|60 minutes downhill running in 10% grade, in an effort of 65% of VO2max.
15852132|NCT04025697|Other|Complete Denture|A conventional CD will be constructed
15852134|NCT04025684|Other|Oral B Indicator 123|Manual toothbrush (medium bristle stiffness; compact head, UK market).
15852135|NCT04025684|Other|Dr Best Original|Manual toothbrush (medium bristle stiffness; regular head, German market)
15852136|NCT04025684|Other|Dr Best Multi Expert|Manual toothbrush (medium bristle stiffness; compact head, German market)
15852137|NCT04025684|Other|parodontax Interdental|Manual toothbrush (soft bristle stiffness; compact head, German market)
15852138|NCT04025671|Device|Nasal Spray Naloxone|Nasal spray naloxone device.
15852139|NCT04025671|Device|Intramuscular Naloxone|A vial of simulated naloxone and syringe with attached needle.
15852140|NCT04025671|Device|Improvised Nasal Atomizer|A naloxone bristoject dose and nasal atomizer device.
15852141|NCT04025658|Drug|Oxytocin|Oxytocin administered intravenously, over 1 minute following delivery of the fetal head
15852142|NCT04025645|Diagnostic Test|MEASUREMENT OF COMMON BILE DUCT PRESSURES|THE PRESSURES OF THE COMMON BILE DUCT WERE MEASURED
15852143|NCT04025632|Drug|zilucoplan|Daily subcutaneous (SC) inection
15852144|NCT04025632|Other|Placebo|Daily subcutaneous (SC) inection
15852145|NCT04025619|Device|tape|Sports tape
15852146|NCT04025606|Drug|Thoracic epidural|Standard thoracic epidural (needle inserted into the space between the covering of spinal cord and the cord itself) preoperatively. Standard thoracic epidural analgesia mixture (2 mg/ ml bupivacaine, 2 µg/ ml fentanyl and 2 µg/ ml adrenalin) with an infusion of 6-10 ml/hour until day 2 postoperatively. Thereafter reduction by 30 % every four hours.
15852147|NCT04025606|Drug|Paravertebral block|Paravertebral block containing 5 ml bupivacaine 5 mg/ ml (optionally 10 ml bupivacaine 2,5 mg/ ml). In addition per-oral painkillers (oxycodone and paracetamol) from the day of surgery.
15852148|NCT04025593|Drug|Cyclophosphamide|750mg/m2 day 1
15852149|NCT04025593|Drug|Rituximab|375mg/m2 day 0
15852150|NCT04025593|Drug|Doxorubicin|50mg/m2 day 1
15852151|NCT04025593|Drug|Vincristine|1.4mg/m2, max 2mg day 1
15852152|NCT04025593|Drug|Prednisone|60mg/m2, max 100mg day 1-5
15852153|NCT04025593|Drug|Ibrutinib|420mg/day qd
15852154|NCT04025593|Drug|Lenalidomide|25mg day1-10
15852155|NCT04025593|Drug|chidamide|20mg day 1,4,8,11
15852156|NCT04025593|Drug|decitabine|decitabine 10mg/m2 day-5 to day-1
15852157|NCT04025580|Biological|Flucelvax|Seasonal influenza vaccine
15852158|NCT04025580|Biological|Fluvirin|Seasonal influenza vaccine
15852159|NCT04025580|Biological|Fluzone High Dose|Seasonal influenza vaccine for adults ages 65 and older
15852160|NCT04025567|Drug|vancomycin|1,500 mg total daily dose, on days 1-21 of every 28 days cycle.
15852162|NCT04025541|Biological|Blood sampling|blood sampling time : cycle 1 day 15 and cycle 2 day 15 : one sample (6ml) by time
15852163|NCT04025528|Procedure|Bariatric Surgery|Weight loss surgery with either gastric sleeve or gastric bypass surgery
15852164|NCT04025502|Device|Event-Related Potentials (ERP) and Electroencephalogram (EEG) testing with the COGNISION® System|The testing protocol consists of an auditory oddball Event-Related Potential (ERP) paradigm, 40Hz ASSR, and the collection of 6 minutes of resting electroencephalogram (EEG). During the ERP paradigm a variety of auditory stimuli are played through the system's earphones while voltage potentials are recorded from the subject's scalp. At the end of the ERP session, 6 minutes of EEG data will be recorded while the subject is resting. The entire procedure, including set up, instructions to the subject and actual test is expected to take 60-75 minutes.
15852165|NCT04025489|Dietary Supplement|Randomized control trial of vitamin D supplementation|This open-label randomized placebo-controlled prospective trial will be randomized into two groups; lifestyle modification counseling along with intervention with either vitamin D or placebo. Anthropometry, body composition, levels of vitamin D, blood glucose (including oral glucose tolerance test) and dietary assessments will be assessed periodically (every 3 months). In those having recurrent vitamin D deficiency, the course of vitamin D will be repeated. Diet and exercise will be recommended as per the regular norms for overweight and obese subjects. Clinical and dietary profile, sunlight exposure, glycemic and lipid profile other metabolic parameters, body composition, hand grip strength, leukocyte telomerase length and telomerase activity will be assessed at enrolment time and one-year intervention. As mentioned above, genes related to ageing will be evaluated. Effects on polymorphisms of pro-ageing genes will be assessed.
15852166|NCT04025476|Drug|Steroids|IV and oral steroids
15852167|NCT04025463|Behavioral|HHMB|Blended, culturally-congruent, evidence-informed care model to increase patient and clinic participation in CVD risk reduction for patients with HIV
15852168|NCT04025450|Drug|Chidamide+VRD|Chidamide:30mg d0,d3,d7,d10/Velcade:1.3mg/m2 d1,d4,d8,d11/ Dexamethasone: 10mg BID d1,d2,d4,d5,d8,d9,d10,d11/Lenalidomide: 25mg d1-d14
15852169|NCT04025450|Drug|VRD|Velcade:1.3mg/m2 d1,d4,d8,d11/ Dexamethasone: 10mg BID d1,d2,d4,d5,d8,d9,d10,d11/Lenalidomide: 25mg d1-d14
15852170|NCT04025437|Procedure|Hepatectomy alone|Patients in this group will receive hepatectomy alone.
15852171|NCT04025437|Radiation|Neoadjuvant radiotherapy|Radiotherapy for type I PVTT will be perfomed before hepatectomy. Hepatic resection will be performed in about 4 weeks after radiotherapy.
15852172|NCT04025424|Genetic|Genetic tests of the available tumor and plasma samples|Only available samples or samples obtainted for other reasons will be used for molecular testing. No special intervention is preplanned
15852173|NCT04025411|Device|Intensive Visual Simulation 3 (IVS3) device|"Visual motor simulation with the Intensive Visual Simulation 3 (IVS3) device will be realized and consist of 5 sessions per week for 4 weeks (20 minutes).
~The patient looks on a screen in front of him, mirroring the movements made by his healthy hand, while attempting to perform the same movement with his paretic hand."
15852174|NCT04025411|Device|traditional Mirror Therapy (TM)|Simulation with the traditional Mirror Therapy (TM) will be realized and consist of 5 sessions per week for 4 weeks (20 minutes).
15852175|NCT04025411|Device|Electroencephalography (EEG)|Electroencephalography (EEG) will be performed during the 1st, 6th, 11th, 16th and 20th session of their programme will be made in order to evaluate brain activity.
15852176|NCT04025398|Behavioral|Cognitive remediation program|Comparison between a cognitive remediation program (REHABILITUS) (group 1) and a training group of manual activities (group 2)
15852469|NCT04023045|Device|Assist-Knee|Assist-Knee is an experimental lower limb knee prosthesis.
15852177|NCT04025398|Behavioral|Control group|"Comparison between a cognitive remediation program (Réhabilitus) (group 1) and a training group of manual activities (group 2)"
15852178|NCT04025385|Other|High Intensity Interval Training|Training for 25 min with four 1 minute intervals when participants exercise up to 80% of their individual limits.
15852179|NCT04025372|Drug|Bicalutamide|Bicalutamide is categorized as an antiandrogen. Antiandrogens are substances that block the effects of testosterone. Cancer of the prostate depends on the male hormone testosterone for its growth. If the amount of testosterone is reduced it is possible to slow down or shrink the cancer.
15852180|NCT04025372|Drug|GnRH Agonist|In men, GnRH agonists cause the testicles to stop making testosterone. Some GnRH agonists are used to treat prostate cancer.
15852181|NCT04025372|Radiation|Radiation Therapy|Radiation Therapy is a cancer treatment that uses high doses of radiation to kill cancer cells and shrink tumors.
15852182|NCT04025372|Drug|Darolutamide|Darolutamide belongs to a class of drugs called androgen receptor inhibitors. In the body, these agents compete with androgens for binding to the androgen receptor, which reduces the ability of androgens to promote the growth of prostate cancer cells
15852183|NCT04025359|Drug|Dronabinol|Dronabinol 10Mg
15852184|NCT04025359|Drug|Dronabinol|dronabinol 20Mg
15852185|NCT04025359|Drug|Placebos|sugar pill
15852186|NCT04025346|Other|Capsimax|1 capsule to be taken before breakfast.
15852187|NCT04025346|Other|Micro Crystalline Cellulose|1 capsule to be taken before breakfast.
15852188|NCT04025320|Other|Intraneural Facilitation|Intraneural Facilitation utilizes three manual holds. Firstly, the contralateral joint is placed in a maximal loose-pack position to pressurize the nervous system and bias circulation from the artery into the epineurium. Now that we have increased this pressure we begin the secondary hold to bias the increased epineurial blood into the transperineurial vessels that bridge the epiperineum and the endoneurial capillaries of the site being treated. Now that the pressure has increased into the open endoneurial capillaries, the goal is to open up ischemic endoneurial capillaries and this is hypothesized to open by providing the third hold. The third hold is known as the sub hold and encourages blood flow through ischemic endoneurial capillaries that have increased resistance/pressure through the application of bernoulli's principle. This treatment will take 50-60 minutes.
15852189|NCT04025320|Other|Sham|A physical therapist will perform the SHAM light therapy at the same site as the INF therapy location, at the Neuropathic Treatment Center. The SHAM light therapy will last 50-60 minutes and consists of using an anodyne unit for application of near-infrared light therapy. The unit will not be switched on, but the pads will be placed on the subject and the subject will be blinded to the unit being on. The anodyne therapy pads will be placed in the following locations on the affected lower limb: two on the plantar aspect of the foot in a T formation and one pad on the medial and lateral side of the calf. A double folded towel will be wrapped around the subject's foot at the electrode sites to blind the subject's from the light not emitting from the electrodes, due to the anodyne unit being off.
15852190|NCT04025307|Drug|bacTRL-IL-12|bacTRL-IL-12 is a live, genetically modified Bifidobacterium longum (B longum), for administration via IV infusion. The probiotic bacteria selectively colonize solid tumour tissues and are engineered to deliver genetic material encoding the pro-inflammatory transgene Interleukin-12 (IL-12). Plasmid DNA encoding the IL-12 transgene is delivered to the patient's cells within the tumor microenvironment, whereupon IL-12 is expressed to stimulate local and systemic anti-tumour immune responses.
15852191|NCT04025294|Device|videogame|A videogame intervention that is interactive and engaging that teaches adolescents how to restructure negative automatic thoughts through an adapted thought record (a technique used in cognitive behavioral therapy to improve moods) by modeling how to do so and then empower them through real-life activities to improve their school climate. The videogame intervention is comprised of five mini-games, each containing a short narrative that models how to restructure negative automatic thoughts and navigate through challenging situations that often take place in school settings. The topics of each mini-game are informed by the constructs of school climate according to the National School Climate Center. Students using the videogame intervention will be prompted to think deeply and reflect on the narratives presented in each mini-game.
15852192|NCT04025294|Behavioral|School Climate Assessment Survey|A school climate assessment survey will include items adapted from questions developed by the National School Climate Center. Items will assess various dimensions of school climate including safety, social media, relationships, support for learning, and environment.
15852193|NCT04025281|Other|Extra Virgin Olive Oil|Participants will consume a meal prepared with 50 mL extra virgin olive oil. The meals will be prepared and provided to the study participants in the cafeteria of Griffin Hospital, where the Prevention Research Center is located. With the exception of the type of olive oil used in the meals, the meal plan will be comparable in all the intervention phases for the same individual.
15852194|NCT04025281|Other|Refined Olive Oil|Participants will consume a meal prepared with 50 mL refined olive oil in the cafeteria of Griffin Hospital. With the exception of the olive oil used, the meal plan will be comparable in each the intervention phases for the same individual.
15852195|NCT04025268|Behavioral|Group Prenatal Care (GPNC)|GPNC participants will attend 11 group sessions total: 10 during pregnancy and one postpartum. Each session will be 90-100 minutes long. Groups will collectively identify the preferred time of day for these sessions. Groups of 10 women will be led by a locally trained, Samoan nurse-midwife with the study Project Director as a co-facilitator. At each of the visits participants will engage in self-assessments of weight and blood pressure, including learning to take their blood pressure with a digital cuff, calculating BMI, and plotting their weight gain on a graph), receive short individual clinical examinations from a midwife, and participate in group discussions about prenatal care, childbirth preparation, and their postpartum care. The session at 6-weeks postpartum will allow women to introduce their babies to the group and share childbirth stories.
15852196|NCT04025268|Behavioral|Standard of Care|Standard of prenatal care
15852197|NCT04025255|Dietary Supplement|Braini|A novel, neuro-protective and neuro-restorative dietary supplement composed of a combination of active ingredients which have been commercially-available since at least 2015 or have achieved FDA new dietary ingredient notification (NDIN) status in 2018
15852198|NCT04025255|Dietary Supplement|Placebo|Matched placebo
15852199|NCT04025229|Behavioral|HIIT exercise|High intensity interval training (4 to 6 sessions) prior to surgery
15852470|NCT04023045|Device|Habitual Prosthesis|Habitual baseline prosthesis prescribed by participant's clinician.
15852200|NCT04025216|Biological|CART-TnMUC1|Single intravenous administration of genetically modified autologous T cells engineered to express a TnMUC1-Targeted Genetically-Modified Chimeric Antigen (CAR)
15852201|NCT04025216|Drug|Cyclophosphamide|Patients will receive cyclophosphamide and fludarabine lymphodepletion chemotherapy followed by the investigational product, CART-TnMUC1
15852202|NCT04025216|Drug|Fludarabine|Patients will receive cyclophosphamide and fludarabine lymphodepletion chemotherapy followed by the investigational product, CART-TnMUC1
15852203|NCT04025203|Other|Median nerve neural mobilization|Manual therapy maneuver performed in the upper limb.
15852204|NCT04025203|Drug|Ibuprofen Arginine|Oral tablets
15852205|NCT04025203|Drug|Gabapentin|oral capsules
15852206|NCT04025177|Drug|Indomethacin Injection|The dose of indomethacin will be 0.1 mg/kg/dose, based on birth weight, intravenously every 24 hours for a total of 3 doses. Doses 2 and 3 may be administered between 23.5 and 24.5 hours after the previous dose. Doses will be rounded to two significant figures.
15852207|NCT04025164|Radiation|Hypofractionated Radiotherapy|daily fractions, 2.66 Gy/3.2 Gy per fraction to whole breast/tumor bed, five fractions per week
15852208|NCT04025164|Radiation|Conventional fractionated Radiotherapy|daily fractions, 2 Gy per fraction, five fractions per week
15852209|NCT04025151|Behavioral|Alcohol brief intervention|At baseline, subjects will receive face-to-face or online alcohol brief intervention developed based on the guideline by the World Health Organisation in 5-10 minutes
15852210|NCT04025151|Behavioral|12-page health warning leaflet|Nurses will provide information about the consequences of drinking using a 12-page health warning booklet. Benefits of reducing and quit drinking will be emphasized by focusing on improving their perception towards the impacts on health, social problems, risky behaviors, academic performance and financial issues.
15852211|NCT04025151|Behavioral|Regular messages through Instant Messaging (IM)|A total of 26 e-messages will be scheduled: once daily for the first week, 3 time/week for subsequent 4 weeks and 1 time/week for the remaining 7 weeks. The frequency will be adjusted according to IM Apps conversation and subject's requests.
15852212|NCT04025151|Behavioral|Real-time chat-based support through IM Apps|The chat-based IM support is the extension of baseline ABI and regular e-messages, which aims to provide real-time behavioral and psychosocial support to reduce or quit drinking. It will be personalized according to the subjects' characteristics (gender, drinking pattern and alcoholic drinks preferences), intention to drink and specific questions regarding drinking. Through real-time chatting (text and/or voice), drinkers can acquire information on consequences of drinking and gain social support immediately to reduce intention to drink and alcohol consumption.
15852213|NCT04025151|Behavioral|General health through SMS|After baseline, they will receive regular e-message through SMS with similar frequency to Intervention group with content on general health and the reminding the importance of participating in the follow-up surveys.
15852214|NCT04025151|Behavioral|AUDIT score interpretation sheet adapted from the Department of Health of Hong Kong|"a diagram explaining drinking behaviour and potential health risks, definitions of alcohol unit and binge drinking, and advise on limiting daily drinking to 2 alcohol units for men and 1 unit for women"
15852215|NCT04025138|Other|Neuromuscular tests in isometric mode|"Protocol for neuromuscular tests in isometric mode will be assessed by the composite of these measures :
~Voluntary maximum forces plantar flexors and knee extensors
~Electrically evoked forces
~ElectroMyoGraphic activity (EMG)
~Three-Modality Evoked Potentials (TMEPs)"
15852216|NCT04025138|Device|Transcranial Magnetic Stimulation (TMS)|Measure of supraspinal activation level and cortical excitation by Transcranial Magnetic Stimulation (TMS).
15852217|NCT04025138|Other|Neuromuscular fatigue assessment test|Neuromuscular fatigue assessment test in dynamic mode will be assessed by the Force/Velocity Profile (FVP) measure: 2 sprints of 8 seconds on a cycle ergometer.
15852218|NCT04025138|Other|treadmill|2 sessions of treadmill will be realized: 8 and 10 km.h-1 for level running and 7 km.h-1 with 10% slope for graded running.
15852219|NCT04025138|Biological|Blood sample|Blood sample will be realized to measure hemorrheologic and hematologic parameters.
15852220|NCT04025138|Biological|Urinary sample|Urinary sample will be realized to measure hemorrheologic and hematologic parameters.
15852221|NCT04025112|Device|Armeo®Power|Randomized patients will be offered rehabilitation robotic using Armeo®Power from Hocoma, the first robotic arm exoskeleton for integrated arm and hand therapy, during one month, three times a week, totalizing 12 sessions of 45 minutes.
15852222|NCT04025112|Other|Conventional rehabilitation protocol|Randomized patients will be offered the conventional rehabilitation protocol from Barretos Cancer Hospital during one month, three times a week, totalizing 12 sessions of 45 minutes.
15852223|NCT04025099|Other|Internal Cues|"The intuitive eating curriculum that was pilot tested and adapted has been modified for use for the Internal Cues group with college-aged females for delivery over a 10-week time period.
~The classes will be delivered by two Registered Dietitians and Certified Intuitive Eating Counselors from the University of Delaware, Julia Katcher and Maryann Eastep.
~During the Internal Cues group's intuitive eating classes, participants will, as a group, eat dinner that is prepared by ServSafe certified undergraduate dietetics students in the test kitchen in the STAR Tower. This dinner will allow the participants to experientially learn the intuitive eating principles taught in class.
~The yoga classes will be adapted to all levels of experience, mobility, and body size. Specific breathing techniques and body positive language will be incorporated into a body-positive yoga training done by Ms. Lisa Jones, RYT."
15852224|NCT04025099|Other|External Cues|"The 10-week traditional healthy weight program for the External Cues group was created by a Graduate Assistant based on MyPlate principles.
~The External Cues classes will be delivered by two Registered Dietitians from the University of Delaware, Julia Katcher and Maryann Eastep.
~During the External Cues group's healthy eating classes, participants will, as a group, eat dinner that is prepared by ServSafe certified undergraduate dietetics students in the test kitchen in the STAR Tower. This dinner will allow the participants to experientially learn how to properly portion their meals to meet their caloric needs, in line with traditional education about weight control.
~Students randomized to the External Cues group will receive a UD fitness pass and will be able to choose from select cardio-based fitness classes in order to meet public health recommendations for physical activity."
15852253|NCT04024826|Behavioral|ELP|This group will perform the Resistance training intervention on the day 18 of the menstrual cycle, which corresponds to the mid of early luteal phase
15855818|NCT03995836|Procedure|Bariatric Surgery|All patients.
15852225|NCT04025073|Other|Dietary Approaches to Stop Hypertension|The DASH diet will have a reduced caloric intake by 400 kcal/day, when compared to the standard hospital diet. The DASH diet will be planned according to the following: total daily energy intake 1,900 kcal; total daily fat intake 27%; daily intake of saturated fatty acids 6%; total daily protein intake 18%; total daily carbohydrates intake 55%; cholesterol 150 mg/day; sodium 2,300 mg/day; potassium 4,700 mg/day; calcium 1,250 mg/day; magnesium 500 mg/day; and fiber 30 g/day.
15852226|NCT04025073|Other|Nutrition education program|The nutrition education program will consist of four lectures intended to improve the overall participants' dietary habits. The lectures will be interactive and will be organized in smaller groups (up to 10 participants) covering the following themes: My Plate dietary guidelines; Principles of a balanced diet; Reading and understanding food nutrition labels; Dietary recommendations for elevated blood pressure, dyslipidemia, and diabetes mellitus.
15852227|NCT04025060|Behavioral|Commercially-available caffeine-free soda|Subjects are asked to consume caffeine-free soda daily for two weeks
15852228|NCT04025060|Behavioral|Carbonated water|Subjects are asked to consume unsweetened, carbonated water daily for two weeks
15852229|NCT04025060|Behavioral|Regular soda|Subjects are asked to consume regular soda daily for two weeks
15852230|NCT04025034|Procedure|Orbital decompression with ultrasonic bone removal|Deep lateral wall partial rim-sparing decompression for thyroid-related orbitopathy using SONOPET® appears to be safe and effective, reducing the complications associated and damage to neurovascular structures.
15852231|NCT04025021|Dietary Supplement|Targeted Fortification|The TPN and SMOF lipids will be optimized to provide a goal of 4 g/kg/day of protein, and 100-130kcal/kg/day. At 100 ml/kg/day of enteral feeds additional liquid protein and/or microlipids will be added to the breast milk to provide goal of 4 g/kg/day of protein and 100-130 kcal/kg/day. This will be determined by analysis of the milk and reported composition. They will continue targeted fortification for 4 weeks after achieving full feeds of 150 ml/kg/day.
15852232|NCT04025021|Device|The Miris Human Milk Analyzer|The Miris human milk analyzer is a mid infrared that reports the amount of energy absorbed at each wavelength. The amount of fat (grams), lactose (grams), total protein (grams), true protein (grams), and energy (kcal) per 100 ml will be reported.
15852233|NCT04024982|Other|Sequence of teaching (Lecture first followed by Simulation)|Sequence of teaching (whether lecture or simulation session first) can help to achieve the maximum skill acquisition in TEE.
15852234|NCT04024982|Other|Sequence of teaching (Simulation first followed by Lecture)|Sequence of teaching (whether lecture or simulation session first) can help to achieve the maximum skill acquisition in TEE.
15852235|NCT04024969|Diagnostic Test|T2* MRI|Research T2* weighted MRI sequence
15852236|NCT04024969|Diagnostic Test|Lumbar puncture to test for presence of unmatched oligoclonal bands|Current clinical standard practice
15852237|NCT04024956|Device|Sealing Device|The Sealing Device is indicated for use in hepato-pancreato-biliary (HPB) surgery to reduce leakage of fluids from the site of surgery into the abdominal cavity and as an adjunctive hemostatic device to control minimal to moderate bleeding at the surgical site.
15852239|NCT04024917|Other|Cardiac coherence|"An initiation session to cardiac coherence will take place D-11 before the operation (during the surgical consultation) in order to obtain a breathing rate of 6 cycles/min via a free application (Respirelax) with listening to an audio tape.
~3 cardiac coherence sessions per day of 5 min (before meals) during the 11 days preceding the operation.
~- The program cardiac coherence will be performed during 90 days after the surgery"
15852240|NCT04024917|Other|Standard care|Standard care
15852241|NCT04024904|Device|OncomfortTM device|The VHRD (Virtual Reality Hypnosis Distraction) technique is the program of OncomfortTM (Oncomfort Inc, Houston, USA). The OncomfortTM device include the hyper vision 3D virtual reality glasses and disposable single-patient-use headphones. The program is an immersive experience focused on inducing relaxation environment and this program exist in 5,15 and 30 minutes
15852242|NCT04024891|Drug|Phentolamine Mesylate Ophthalmic Solution 1%|1% phentolamine mesylate ophthalmic solution (Nyxol), a non-selective alpha-1 and alpha-2 adrenergic antagonist
15852243|NCT04024891|Other|Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)|Topical Sterile Ophthalmic Solution
15852244|NCT04024878|Drug|Nivolumab|Nivolumab (Opdivo®) is an antibody. An antibody is a common type of protein produced by the body that the immune system uses to find and destroy foreign molecules.
15852245|NCT04024878|Biological|NeoVax|"The vaccine will consist of up to 20 peptides as well as a drug that activates the immune system called Poly-ICLC. Poly-ICLC (also called Hiltonol) is an experimental viral mimic and an activator of immunity"
15852246|NCT04024878|Procedure|Core Needle Biopsy|Surgical procedure
15852247|NCT04024865|Drug|Domperidone|Women who received a prescription for domperidone (ATC A03FA03) during the six months following delivery.
15852248|NCT04024852|Other|Intervention group|When Air Quality Health Index is below level 5, the intervention group did daily mild exercise (walking) outdoors for 30 minutes. When Air Quality Health Index is equal to or above level 5, the group is advised to do mild exercise indoors for 30 minutes.
15852249|NCT04024839|Other|Active Isolated Stretch|In supine position, participant was asked to lock the knee and slowly lift leg using the quadriceps muscles. gentle assistance was given by the rope at the end of the movement, as the quadriceps muscles continue to move the leg. strech was applied for 2 sec and then release to starting position. two sets of 10 repetitions were performed.
15852250|NCT04024839|Other|Post Isometric Relaxation|In supine line, participant was asked to do SLR until resistance was met in hamstring muscles and then was asked to do isometric contraction (10-20% of maximum) for 5 - 10 sec and inhale. After this, patient was asked to exhale while doing so gentle stretch was applied till the new barrier. Starting from this new barrier, the procedure was repeated 2 - 3 times.
15852251|NCT04024826|Behavioral|EFP|This group will perform the Resistance training intervention on day 4 of the menstrual cycle, which corresponds to the mid of early follicular phase.
15852252|NCT04024826|Behavioral|LFP|This group will perform the Resistance training intervention on day 11 of the menstrual cycle, which corresponds to the mid of late follicular phase.
15852254|NCT04024826|Behavioral|LLP|This group will perform the Resistance training intervention on day 21 of the menstrual cycle, which corresponds to the mid of late luteal phase
15852255|NCT04024813|Drug|Seladelpar|Capsule(s) administered orally once daily
15852256|NCT04024813|Drug|Placebo to match Seladelpar|Capsule(s) administered orally once daily
15852257|NCT04024800|Biological|AE37 Peptide vaccine|"Starting dose: AE37 vaccine 1000 micrograms split into 2 doses given as intradermal injection on day 1 of every 3 week cycle (21 day cycle) for 5 cycles.
~Should ≥ grade 3 systemic toxicities (DLT) occur in > 25% (4) of the first 13 patients (4 or more) the study therapy vaccine dose will be de-escalated to 500 micrograms (dose level -1)."
15852258|NCT04024800|Biological|Pembrolizumab|Pembrolizumab 200 mg IV on day 1 of every 3 week cycle (21 day cycle) for 2 years (35 cycles)
15852259|NCT04024787|Behavioral|Cognitive-Behavioural therapy for insomnia (CBT-I)|"Participants with chronic primary insomnia are randomized into 2 groups with a 1:1 allocation ratio, after the completion of the pre-treatment assessment. Post-treatment and post-waitlist assessment occur after the 3-month treatment or waiting period.
~One group will receive the intervention immediately after the pre-treatment assessment and the other group will receive the intervention after a waiting period of 3 months. The intervention consists of manualized cognitive-behavioural therapy for insomnia. This treatment includes psychoeducation about sleep and circadian rhythms, stimulus control, sleep restriction, relaxation, and cognitive therapy. The therapy is administered individually. Participants meet for 8 sessions of 50 minutes spread over 12 weeks."
15852260|NCT04024774|Biological|Biological samples|blood samples, urine samples, tissue samples
15852261|NCT04024774|Genetic|Genetic test|anamnesis and NGS sequencing
15852262|NCT04024761|Biological|CIML NK|CIML NK cells have enhanced ability to recognize and kill leukemia targets
15852263|NCT04024761|Drug|Fludarabine|Fludarabine is a chemotherapy drug Chemotherapy is most effective at killing cells that are rapidly dividing.
15852264|NCT04024761|Drug|Cyclophosphamide|Cyclophosphamide (CP), also known as cytophosphane among other names, is a medication used as chemotherapy and to suppress the immune system.
15852265|NCT04024748|Device|PET/CT imaging|Subjects will be have a PET/CT scan with PCD-1000A following their scheduled routine PET/CT scan. There will be no additional administration of radiopharmaceutical for the study.
15852266|NCT04024735|Diagnostic Test|Spirometry, Forced Oscillation Technique, Step-counter, sputum and blood samples|We will be collecting demographic and clinical information including daily physical activity level, lung function, blood and sputum samples. These measurements will be collected at patient admission, discharge and at follow-up of 30 and 90 days.
15852267|NCT04024722|Procedure|In Vitro Fertilization|Patients suitable for research with poor ovarian response will receive treatment including laparoscopic surgery, resection, and transplantation of ovarian tissue in the same operation to improve the chances of success of in vitro fertilization and pregnancy. Participants will be assessed for surgical incisions and fertility assessment up to two weeks after treatment, including general physical examination, US pelvic examination, and blood tests for a hormonal profile to determine the initiation of ovarian stimulation and IVF. Patients will be monitored from 2 weeks to 1 year after treatment (once a week in the first two months and one month for one year after surgery), which will include a general physical examination, a US test, and blood tests for the hormonal profile at the IVF clinic.
15852268|NCT04024709|Procedure|Gastric Peroral Endoscopic Myotomy|Creation by submucosal dissection of a tunnel in the gastric wall at the level of the antrum, then of a pyloric and antral myotomy, before closing the mucosal access by clips.
15852269|NCT04024696|Drug|Abexinostat|Abexinostat Tosylate Tablets
15852270|NCT04024683|Procedure|Serratus block with ropivacaine 2mg/ml|The serratus block was made using a 50 mm needle with ultrasound guidance. It was performed supine, the ultrasound probe identifying the 3, 4 or 5th intercostal space and then the needle was introduced under ultrasound control
15852272|NCT04024631|Other|75g glucose beverage (Glucola, Trutol, or similar brand)|Subjects will present fasting to the study day and ingest the glucose beverage during the oral glucose tolerance test.
15852273|NCT04024631|Other|DXA, whole body|Subjects will undergo a whole body DXA scan for assessment of adiposity index and body fat distribution.
15852274|NCT04024618|Procedure|Parenteral Nutrition/Enteral Nutrition|Patients randomized to the parenteral nutrition arm will receive nutrition by IV and patients randomized to the enteral nutrition arm will receive nutrition by NG tube.
15852275|NCT04024605|Dietary Supplement|Sunflower|Plant proteins are intrinsically enriched with 15N and 2H. There are incorporated into biscuits. The biscuits are formulated to supply 20 g of plant protein per volunteer.
15852276|NCT04024605|Dietary Supplement|Rapeseed|Plant proteins are intrinsically enriched with 15N and 2H. There are incorporated into biscuits. The biscuits are formulated to supply 20 g of plant protein per volunteer.
15852277|NCT04024605|Dietary Supplement|Flaxseed|Plant proteins are intrinsically enriched with 15N and 2H. There are incorporated into biscuits. The biscuits are formulated to supply 20 g of plant protein per volunteer.
15852278|NCT04024605|Dietary Supplement|Lupin|Plant proteins are intrinsically enriched with 15N and 2H. There are incorporated into biscuits. The biscuits are formulated to supply 20 g of plant protein per volunteer.
15852279|NCT04024592|Device|Biodex System 4|Reliability and validity of isokinetic strength measurement of the knee, hip and ankle in typically developing children.
15852280|NCT04024566|Device|Vivio System|Optical/sensor tonometer applied to the neck over the carotid pulse (bilateral)
15852281|NCT04024540|Dietary Supplement|isocaloric dietary restriction|Very low caloric diet
15852282|NCT04024540|Procedure|Bariatric surgery|Laparoscopic vertical sleeve gastrectomy
15852283|NCT04024527|Drug|Esomeprazole|Proton pump inhibitor
15852284|NCT04024527|Drug|Amoxicillin|Antibiotic for H. pylori eradication
15852285|NCT04024527|Drug|Metronidazole|Antibiotic for H. pylori eradication
15852286|NCT04024514|Other|low dose CT contrast media|CT contrast media (Ioversol 320mgI/kg) is administrated at a dose of 300mgI/kg in low dose group
15852851|NCT04019951|Dietary Supplement|Ca-propionate 3 g|3 g of Ca-propionate will be mixed in 203 mL of a standardized liquid breakfast
15852287|NCT04024514|Other|Standard dose CT contrast media|CT contrast media (Ioversol 350mgI/kg) is administrated at a dose of 525mgI/kg in standard dose group.
15852288|NCT04024501|Drug|Verinurad ER8 capsule formulation (fasted)|Each participant will receive single-dose treatment of 12 mg verinurad ER8 capsule with 240 mL water, following an overnight fast of at least 10 hours.
15852289|NCT04024501|Drug|Verinurad A-capsule formulation (fasted)|Each participant will receive single-dose treatment of 12 mg verinurad A-capsule with 240 mL water, following an overnight fast of at least 10 hours.
15852290|NCT04024501|Drug|Verinurad A-capsule formulation (fed)|Each participant will receive single dose treatment of 12 mg verinurad A-capsule with 240 mL water, following a high-fat, high-calorie breakfast (after the overnight fast).
15852291|NCT04024501|Drug|Verinurad B-capsule formulation (fasted)|Each participant will receive single-dose treatment of 12 mg verinurad B-capsule with 240 mL water, following an overnight fast of at least 10 hours.
15852292|NCT04024501|Drug|Verinurad B-capsule formulation (fed)|Each participant will receive single dose treatment of 12 mg verinurad B-capsule with 240 mL water, following a high-fat, high-calorie breakfast (after the overnight fast).
15852293|NCT04024488|Behavioral|TI-CBT Intervention Arm|"TI-CBT teaches techniques and ways to manage distress through psychosocial health education, cognitive restructuring, and mastery of trauma, which refers to the process by which survivors of psychological trauma work through the traumatic experience in a meaningful way, and are able to move on with life. TI-CBT addresses both the trauma of learning one has HIV and the trauma associated with managing a chronic and stigmatized illness. The intervention highlights links between HIV and traditional gender roles, gender inequities, and gender based violence. Finally, the relaxation training teaches youth strategies to relax and these are integrated at the beginning and end of each session. TI-CBT Youth and Caregiver Intervention Manuals are distributed to sites for translation, backtranslation, and cultural adaptation in preparation for the Randomized Trial."
15852294|NCT04024488|Behavioral|Discussion Control Arm|Each youth discussion control group session will be led by IYL and each caregiver discussion control group will be led by adult study staff. Discussion topics will be selected by youth and caregivers in the group as applicable. Discussion Control group session will take place at a separate time from TI-CBT youth group sessions in attempt to minimize contamination. To note, participant and caregiver group sessions are always held separately.
15852295|NCT04024475|Other|Observation|
15852296|NCT04024462|Drug|Pertuzumab IV|Pertuzumab will be administered as a fixed non-weight-based loading dose of 840-milligrams (mg) IV and then a 420-mg IV maintenance dose Q3W.
15852297|NCT04024462|Drug|Trastuzumab IV|Trastuzumab will be administered as an 8-milligram per kilogram of body weight (mg/kg) IV loading dose and then 6 mg/kg IV maintenance dose Q3W.
15852298|NCT04024462|Drug|Pertuzumab and Trastuzumab FDC SC|The pertuzumab and trastuzumab fixed-dose combination for subcutaneous administration (PH FDC SC) will be administered SC at a fixed non-weight-based dose. A loading dose of 1200 mg SC pertuzumab and 600 mg SC trastuzumab is then followed by a maintenance dose of 600 mg SC pertuzumab and 600 mg SC trastuzumab Q3W.
15852299|NCT04024462|Drug|Doxorubicin|Doxorubicin 60 milligrams per meter squared of body surface area (mg/m^2) will be administered IV on Day 1 of each cycle of treatment (as part of AC Q3W) for Cycles 1-4.
15852300|NCT04024462|Drug|Cyclophosphamide|Cyclophosphamide 600 mg/m^2 will be administered IV on Day 1 of each cycle of treatment (as part of AC Q3W) for Cycles 1-4.
15852301|NCT04024462|Drug|Docetaxel|Docetaxel 75 mg/m^2 will be administered IV on Day 1 of Cycle 5. At the investigator's discretion the dose may be escalated to 100 mg/m^2 IV for Cycles 6-8 (Q3W) provided no dose-limiting toxicity occurs.
15852302|NCT04024462|Procedure|Surgery|Participants in both cohorts are scheduled to undergo surgery after 8 cycles of neoadjuvant therapy. Participants may undergo breast-conserving surgery or mastectomy according to routine clinical practice.
15852303|NCT04024462|Radiation|Post-Operative Radiotherapy|If indicated, radiotherapy is given after chemotherapy and surgery, during adjuvant HER2-targeted therapy and hormone therapy (for hormone-receptor positive disease).
15852304|NCT04024462|Drug|Hormone Therapy|For hormone receptor positive breast cancer, tamoxifen or aromatase inhibitors will be allowed as adjuvant hormone therapy for postmenopausal participants and with ovarian suppression or ablation for premenopausal participants in countries where it has been registered for this indication. Its use must be consistent with the registered label. Hormone therapy is given after chemotherapy and surgery during adjuvant HER2-targeted therapy.
15852305|NCT04024449|Other|Group A|ovarian function test in control group
15852306|NCT04024436|Drug|Futibatinib|Futibatinib 20mg once daily on a 28 day cycle
15852307|NCT04024436|Drug|Futibatinib plus Fulvestrant|Futibatinib 20mg once daily and 500 mg fulvestrant administered intramuscularly (IM) on Days 1 and 15 of Cycle 1, then on Day 1 of Cycle 2 and beyond on a 28-day cycle.
15852308|NCT04024423|Other|Epidemiologic investigation|Identification of overlaps in source(s) of care between participants with NTM isolates in a Cystic Fibrosis Care Center.
15852309|NCT04024410|Other|Evaluation of PEEP in prone position|Assessment of optimal Positive End-Expiratory Pressure (PEEP) in patients undergoing scheduled spine surgery in prone position.
15852310|NCT04024384|Drug|Daratumumab|Daratumumab, 16 mg/kg, once a week for 8 weeks (cycles 1 and 2); then every 2 weeks for 16 weeks (cycles 3-6), then every 4 weeks thereafter (cycles 7-12).
15852311|NCT04024371|Behavioral|Self-rating Questionnaires|"Snaith-Hamilton Pleasure Scale (SHAPS; Snaith et al. 1995)
~Quick Inventory of Depressive Symptomatology (QIDS; 16 items)
~Behavioral avoidance/inhibition Scales (BIS/BAS)"
15852312|NCT04024371|Behavioral|Measures of Reward processing/reinforcement learning|"Grip Strength Effort Task (Reddy et al. 2015; in combination with EEG)
~Doors (Gambling) task (Foti and Hajcak 2009; in combination with EEG)
~Reinforcement Learning/Working Memory task (Collins et al. 2017; no EEG)"
15852313|NCT04024371|Behavioral|Additional Schizophrenia-specific Questionnaires and Interviews|"Positive and Negative Syndrome Scale (PANSS: Kay et al. 1987)
~Brief Negative Symptom Scale (BNSS; Kirkpatrick et al. 2011)"
15852314|NCT04024345|Diagnostic Test|Barratt Simplified Measure of Social Status (BSMSS)|Questionnaire that evaluates cultural identity, educational level and occupation of the subject and the subject's parents and spouse (if any)
15852315|NCT04024345|Diagnostic Test|Global Assessment of Functioning scale (GAF)|Used to measure overall levels of functionality of an individual
15852852|NCT04019951|Dietary Supplement|Placebo|2.6 g of cellulose will be mixed in 203 mL of a standardized liquid breakfast
15852316|NCT04024345|Diagnostic Test|General Self-Efficacy Scale (GSES)|Psychometric scale that is designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life
15852317|NCT04024345|Diagnostic Test|Perceived Stress Scale (PSS)|To assess the perceived stress
15852318|NCT04024345|Diagnostic Test|Coping Orientation to Problems Experienced (Brief COPE),|It evaluates the subject's coping style through investigation of problem-solving abilities and emotional fluctuation, as a response to stressful situations
15852319|NCT04024345|Diagnostic Test|Multidimensional Scale of Perceived Social Support (MSPSS)|to explore the subject's social support system
15852320|NCT04024332|Drug|ACT-541468|ACT-541468 25 mg; administered orally
15852321|NCT04024319|Procedure|Genicular Nerve Block|4 ml of local anesthetic were administered in 5 genicular nerves. A total volume of 20 ml were administered in GNB group.
15852322|NCT04024306|Device|Ultrafiltration|Using ultrafiltration to extract the fluid overload from the body of the patients
15852323|NCT04024293|Device|Goldfish (GF)|The GF lens (SCL) will be place on participant's eye for a 24h IOP recording session
15852324|NCT04024280|Other|Physical exercise program|Frequency: 3 weekly sessions. Intensity of aerobic training: reporting 12-17 in the Borg scale. Time of aerobic training: 10 minutes in the first and second weeks and then 2 added minutes at each 2 weeks. Type of aerobic training: walking and stepping. Intensity of resistance training: without load in the first week and, then, 15 submaximal repetitions. Time of resistance training: 30 minutes. Type of resistance training: using free weights; the lower body exercises will be squat, leg extension, leg curl and calf raise; the upper body exercises will be frontal and lateral arm raise, chest press, seated row and bicep curl.
15852325|NCT04024267|Other|Eurythmy therapy|Mind-body therapy
15852326|NCT04024267|Other|CoordiFit|Fitness training
15852327|NCT04024254|Drug|Folic Acid Tablet|Folic Acid 1 mg by mouth daily
15852328|NCT04024241|Device|Flow Cytometer|high dose
15852329|NCT04024241|Drug|Mitoxantrone|high dose
15852330|NCT04024241|Drug|Cytarabine|high dose
15852331|NCT04024228|Biological|Standard-Dose influenza virus surface antigens (haemagglutinin and neuraminidase), Inactivated, Influenza Vaccine Quadrivalent, 2019-2020 Northern Hemisphere Strains (QIV-SD)|Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM
15852332|NCT04024228|Biological|High-Dose Influenza Vaccine (split virion, inactivated), Quadrivalent (QIV-HD) 2019-2020 Northern Hemisphere formulation|Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM
15852333|NCT04024215|Device|intravascular ultrasound|IVUS creates axial images perpendicular to the long axis of the catheter by transmitting sound waves covering 360 degrees around the tip of the catheter, which is delivered into the lumen of the vessel over a guidewire.
15852334|NCT04024189|Other|Survey|Patients were given a questionnaire/survey to complete in respect of their satisfaction of the consent process for their surgical procedure
15852335|NCT04024176|Other|Gait analysis|The duration of participation of each subject is equal to the duration of the examination, i.e. approximately 30 minutes for the gait analysis and 30 minutes for the clinical examination (including 10 minutes for completing the questionnaire). The experiments will be carried out in a single measurement session, including several steps.
15852336|NCT04024163|Drug|Benznidazole|Drug: Benznidazole Tablets 100 mg (functionally scored) or Tablets 12.5 mg
15852337|NCT04024150|Biological|Blood test|Single blood sample of 2 ml at birth on the occasion of blood sampling routine checkup
15852338|NCT04024137|Drug|ZSP1273 200 mg|1 X 200-mg tablet taken orally
15852339|NCT04024137|Drug|Placebo|2 tablets taken orally
15852340|NCT04024137|Drug|ZSP1273-400 mg|2 X 200-mg tablet taken orally
15852341|NCT04024137|Drug|Placebo|1 tablet taken orally
15852342|NCT04024137|Drug|ZSP1273-600 mg|3 X 200-mg tablet taken orally
15852343|NCT04024137|Drug|Placebo|3 tablets taken orally
15852344|NCT04024137|Drug|Placebo|Subjects will receive matching placebo of ZSP1273
15852345|NCT04024111|Behavioral|KONTAKT(c)|KONTAKT is a manualized Social skills group training program designed for children and adolescents on the Autism Spectrum aimed at improving communication, social interaction skills, the severity of ASD symptoms, and the ability to empathise and adapt in a group setting. The KONTAKT participants (4-8 participants) meet face to face weekly for 16 weeks for 75 minutes facilitated by two health professionals with experience of running groups for autistic children
15852346|NCT04024111|Other|Art group|Art program, a manualized Art group delivered in a social format, has been designed for children on the Autism Spectrum delivered by health professionals with experience of running social groups for Autistic children. The Art program's participants (4-8 participants) meet face to face weekly for 16 weeks for 75 minutes.
15852347|NCT04024085|Other|completion of the test created Time to be Ready to Void|completion of the test created (Time to be Ready to Void) The participants have to stand up from a chair with armrests, walk 6 meters to the toilet, open the door and turn on the light, close the door, undress and position themselves to urinate
15852348|NCT04024072|Drug|Brinzolamide 1% ophthalmic suspension|Test product
15852349|NCT04024072|Drug|Azopt 1% Ophthalmic Suspension|Reference product
15852350|NCT04024059|Behavioral|Contingency Management for adherence|Incentives contingent on buprenorphine adherence
15852351|NCT04024059|Behavioral|Contingency Management for abstinence|Incentives contingent on opiate abstinence
15852352|NCT04024046|Dietary Supplement|Uqora|Participants will receive 1 Placebo Drink-Mix and 2 Placebo Capsules Daily
15852353|NCT04024046|Dietary Supplement|Group1|Participants will receive 1 Uqora Drink-Mix and 2 Placebo Capsules Daily
15852354|NCT04024046|Dietary Supplement|Group 2|Participants will receive 1 Uqora Drink-Mix and 2 Uqora Capsules Daily
15852355|NCT04024033|Dietary Supplement|pine cone extract|pine cone extract capsule
15852356|NCT04024033|Other|placebo|placebo capsule
15852357|NCT04024020|Other|lumbar puncture|Subjects will have a lumbar puncture to collect cerebrospinal fluid collection
15852358|NCT04024007|Diagnostic Test|Citrate dosage|Patients are dialysed according to the standard of care. Biological variables are measured in pre-filter, post-filter and dialysate 30 minutes after the dialysis is initiated.
15852458|NCT04023123|Other|Ophthalmic imaging|Optical coherence tomography Topography Ocular Response Analyzer Optical Biometry Slit lamp photos
15852359|NCT04023994|Drug|RO7126209|Participants will be administered single-ascending intravenous doses of RO7126209 with at least 2 weeks between each dose level. After the starting dose, the subsequent doses will be selected in an adaptive design. Sentinel dosing will be employed.
15852360|NCT04023994|Drug|Placebo|Participants will be administered a single intravenous dose of matching placebo.
15852361|NCT04023981|Device|Parafricta bootees|Parafricta bootees are a medical device designed to eliminate skin damage due to friction and shear. The basis of Parafricta bootees is a low friction material and bi-layer construction to make the material of the bootee slide on itself when movement of the foot would otherwise bring friction and shear to bear on the skin.
15852362|NCT04023968|Behavioral|YESplus workshop|"See description in Arms section."
15852363|NCT04023968|Behavioral|WOW! workshop|"See description in Arms section."
15852364|NCT04023955|Behavioral|Twitter|Participants received a daily tweet over a period of one-month with educational messages about HPV vaccine and cervical cancer
15852365|NCT04023942|Behavioral|Weight maintenance intervention|Weight maintenance intervention (52 weeks): After randomization, participants will follow either a low carb or a low fat diet and get nutritional assistance either by an app or a newsletter, based on the group they got randomized to (low carb/app, low carb/newsletter, low fat/app, low fat/newsletter).
15852366|NCT04023929|Procedure|Cord blood sampling|A cord blood sample will be obtained after the baby has been delivered and the cord has been clamped and cut.
15852367|NCT04023916|Drug|Sintilimab-R-CHOP|"Drug:Sintilimab:
~Sintilimab:200 mg IV on Day 1 Cycles 2-8, during induction treatment, followed by 200 mg IV on Day 1 of Cycles 9-14.
~Drug: Rituximab Rituximab:Participants with previously untreated DLBCL will receive rituximab at a dose of 375 mg/m^2 IV on Day 1 of Cycle 1-8, during induction treatment.
~Drug: Cyclophosphamide Cyclophosphamide will be administered at a dose of 750 mg/m^2 IV on Day 2 of Cycle 1-6, during induction treatment.
~Drug: Doxorubicin Hydrochloride Liposome Injection Doxorubicin Hydrochloride Liposome Injection will be administered at a dose of 35 mg/m^2 IV on Day 2-3 of Cycle 1-6, during induction treatment.
~Drug: Vincristine Vincristine will be administered at a dose of 1.4 mg/m^2 (maximum 2 mg) IV on Day 2 of Cycle 1-6, during induction treatment.
~Drug: Prednisone Prednisone will be administered at a dose of 40 mg/m^2 orally on Days 1-5 of Cycle 1-6, during induction treatment. Prednisolone may be given if prednisone is unavailable."
15852368|NCT04023903|Drug|Bardoxolone methyl|Bardoxolone methyl 5 mg capsules
15852369|NCT04023903|Drug|Bardoxolone methyl|Bardoxolone methyl 5 mg capsules
15852370|NCT04023877|Drug|E2027|E2027 oral capsule.
15852371|NCT04023864|Dietary Supplement|Platycodon Grandiflorus Extract(GCWB107)|Once-daily, once a tablet, after meals, for 12 week
15852372|NCT04023864|Dietary Supplement|Placebo|Placebo for 12 week
15852373|NCT04023851|Device|Mobile application Brain4U|Brain4U application provides participants to record seizures, medications, side effects, and combined psychiatric problems. It also reminds participants when to take antiepileptic drugs.
15852374|NCT04023838|Procedure|artery puncture and coronary angiography|We will perform coronary angiography through a Judkins 5 French diagnostic catheter and will take a basic view. At the end of the examination, the radial sheath is removed and the right conventional radial approach is performed for about 4 hours and the left snuffbox approach for about 2 hours using the compressive bandage method. The hemostatic device will use ez ClotRadial® (SOYEON medical Co., Ltd., Wonju, Korea).
15852375|NCT04023825|Drug|suprazygomatic maxillary nerve block|in the experimental group, each child will profit from the realization of a suprazygomatic maxillary nerve block.
15852376|NCT04023786|Procedure|PEEP-TEST|The PEEP test will consist of lowering the PEEP level to 5 cmH2O for a maximum of 2 minutes and a minimum of 1 minute. Patients will be included if the physicians who care for them have decided to set a baseline PEEP level ≥10 cmH2O.
15852377|NCT04023773|Device|Liver Machine Perfusion (MP) device|Donor livers will have ex vivo continuous perfusion on the institutional-developed Liver MP device. The temperature of liver grafts will be controlled during perfusion.
15852378|NCT04023760|Drug|Apixaban|Study subjects given a single-dose of apixaban 10 mg.
15852379|NCT04023734|Behavioral|Reminders, habit-based strategies and/or involvement of family member|"Strategies to cope with forgetfulness include reminders, habit-based strategies and/or involvement of family members. The use of a reminder tool and pill boxes will be encouraged and a reminder app can be implemented if patients own a mobile phone. The habit-based strategy will be delivered through a printed worksheet which is tailored to patient's daily routine. Patients will be asked to identify the appropriate place and time to take their medication, and an action they conduct every day that could serve as a prompt or cue to take their medication. Patients will be asked to write coping plans to formulate their own if-then plans for all daily doses of their antihypertensive drug(s). Moreover, patients will be asked to choose a family member to become their treatment supporter. This individual will be asked to support patients to take the antihypertensive drugs. Pharmacists will remind patients to take his/her completed worksheet to the next visit."
15852380|NCT04023734|Behavioral|Counselling to increase knowledge|The content of the counselling to cope with lack of knowledge will focus on educating patients about the purpose of the medication, when and how to take the medication, the need for long-term use, the importance of medication adherence, and how to deal with possible side effects. To explore which education is needed, the patient will be asked whether they know why and how to take their medication. The teach-back method will be used, where the patient is asked to explain the pharmacist what he/she has understood after receiving the education.
15852381|NCT04023734|Behavioral|Counselling to increase motivation|The content of the counselling to cope with lack of motivation will focus on exploring and discussing their concerns and necessity beliefs. This method is called motivational interviewing. This is done by asking a first question about whether the medication bothers the patient. Follow-up on this question can focus on any concerns or low necessity beliefs (e.g., when patients are bothered by the medication because they think the medication is not needed or are afraid of side-effects).
15852382|NCT04023734|Behavioral|Explore/address other drug related problems|The content of the counselling to address other drug related problems will focus on exploring these other problems underlying the non-adherence, for example experiencing side effects, costs, polypharmacy, difficulty to refill antihypertensive drugs in time, or medication intake problems, and offering solutions/alternatives when possible.
15852459|NCT04023110|Drug|Carvedilol|Individually dosed carvedilol
15852854|NCT04019925|Device|ADM/MDM hip|Dual Mobility Hip prosthesis manufactured by Stryker Orthopaedics: ADM/MDM
15852383|NCT04023734|Behavioral|Usual care based on the Indonesian guideline|Patients in five CHCs randomized to the control group will receive pharmacist counselling based on the Indonesian guideline of pharmacy practice. At each visit, they will receive information about the quantity and dose of the dispensed drugs, when and how to use and store the drugs, side effects and how to deal with them, the importance of medication adherence, and confirming if the patient understands how to take medications correctly.
15852384|NCT04023721|Drug|Inarigivir soproxil|Inarigivir soproxil 200 mg tablets
15852385|NCT04023721|Drug|Nucleoside/nucleotide (NUC) analogue inhibitors|Continuation of prestudy NUC therapy
15852386|NCT04023708|Drug|CYD-TDV Dengue Vaccine|Pharmaceutical form:Solution Route of administration: Intramuscular
15852387|NCT04023695|Drug|Corticosteroid with lidocaine with epinephrine|Trigger finger injection
15852388|NCT04023695|Drug|Corticosteroid with normal saline|Trigger finger injection
15852389|NCT04023682|Drug|Provodine Hand Sanitizer|Intervention with Provodine
15852390|NCT04023669|Drug|Prexasertib|IV
15852391|NCT04023669|Drug|Cyclophosphamide|IV
15852392|NCT04023669|Drug|Gemcitabine|IV
15852393|NCT04023669|Biological|filgrastim|Given subcutaneously (SQ). Alternatively, pegfilgrastim may be given.
15852394|NCT04023669|Biological|peg-filgrastim|Given subcutaneously (SQ). Alternatively, filgrastim may be given.
15852395|NCT04023643|Other|Ventilation Weaning|Use of different weaning strategies
15852396|NCT04023630|Drug|Rivaroxaban 15 MG Oral Tablet|One 15 mg tablet once daily for up to twelve months
15852397|NCT04023630|Drug|Clopidogrel 75 Mg Oral Tablet|One 75 mg tablet once daily for up to twelve months
15852398|NCT04023630|Drug|Ticagrelor 90 MG Oral Tablet|One 90 mg tablet twice daily for up to twelve months
15852399|NCT04023617|Drug|Nivolumab|Nivolumab 300mg + docetaxel 75mg/m2 IV q3w Nivolumab 200mg IV q2w
15852402|NCT04023591|Procedure|Surgery/Occupational Therapy|Surgery based on function and injury/ Occupational therapy for 48 months post-surgery
15852403|NCT04023578|Device|RHEO KNEE XC|Microprocessor controlled knee using Magneto-Rheologic techonology.
15852404|NCT04023565|Drug|perindopril + moxonidine|"After 14 days of wash-out period perindopril 10 mg + moxonidine 0.4 mg a day will be prescribed.
~If target BP is achieved after 4 weeks, the dosage will remain unchanged (perindopril 10 mg + moxonidine 0.4 mg a day (given as two divided doses).
~If target BP is not achieved after 4 weeks, the dosage will increase up to perindopril 10 mg + moxonidine 0.6 mg a day (given as two divided doses)."
15852405|NCT04023552|Drug|TQJ230|TQJ230 80 mg injected monthly administered subcutaneously
15852406|NCT04023552|Drug|Placebo|Placebo to match TQJ230 prefilled syringe to be injected subcutaneously
15852407|NCT04023539|Dietary Supplement|Cinnamomum zeylanicum|Capsules of 2 g cinnamomum zeylanicum orally
15852408|NCT04023539|Other|Placebo|Placebo capsules
15852409|NCT04023526|Drug|Azacitidine|Azacitidine SC or IV will be administered at a standard dose of 75 mg/m^2 on days 1-7 of each cycle.
15852410|NCT04023526|Drug|Cusatuzumab|Cusatuzumab IV will be administered as 10 mg/kg or 20 mg/kg on days 3 and 17 of each cycle.
15852411|NCT04023513|Other|High protein intake|6 weeks of high protein intake mainly via food (additional 1g/kg bw/d) followed by a 8 weeks resistance training (Progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the protein intake remains.
15852412|NCT04023513|Other|Control, no intervention|No Intervention, control
15852413|NCT04023513|Other|Low protein intake|6 weeks of low protein intake (1g/kg bw/d) followed by a 8 weeks resistance training (Progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the protein intake remains
15852414|NCT04023513|Other|Strength training|6 weeks of different protein intake followed by a 8 weeks resistance training (Progressive strength training in a fitness center is applied; the intensity is adjusted continuously in order to obtain a sufficient training stimulus). During the training period the protein intake remains
15852415|NCT04023500|Behavioral|Motivational interview vs. prevailing education|"In intervention group dental hygienists are trained to focus on patients view of their oral health, self-care skills and need for oral-health related behaviour change. They are supposed to use open-ended questions, reflective listening and reinforcing with patients.
~In control croup dental hygienist defined patients educational needs and gave direct instructions how to change behaviour and self-care."
15852416|NCT04023487|Behavioral|Resilient, Empowered, Active Living-Telehealth (REAL-T)|REAL-T is an individually-tailored occupational therapy intervention that focuses on incorporating diabetes self-care into participants' daily habits and routines. Participants receive approximately 12 hours of intervention, delivered via telehealth over 6 months by a licensed occupational therapist with training in diabetes education, motivational interviewing, and the REAL Diabetes intervention protocol.
15852417|NCT04023474|Procedure|Platelet Rich Fibrin (PRF) Application|Platelet Rich Fibrin application to flap defect.
15852418|NCT04023461|Device|PVAC GOLD catheter ablation|Isolation of pulmonary veins using PVAC GOLD catheter.
15852419|NCT04023448|Procedure|transverse coloplasty pouch|a transverse coloplasty pouch was performed before end to end colon-rectum (or anal canal) anastomosis
15852460|NCT04023097|Device|Toothwave toothbrush|Subjects get the device's box with the user manual and the device. However, they don't use the device, but only read the user manual and fill questionnaires.
15852461|NCT04023084|Drug|Crisaborole|Crisaborole 2% topical ointment applied twice daily to affected area(s) for 28 days
15852462|NCT04023071|Drug|FT516|Experimental Interventional Therapy
15852463|NCT04023071|Drug|Rituximab|Monoclonal Antibody
15852464|NCT04023071|Drug|Obinutuzumab|Monoclonal Antibody
15852420|NCT04023435|Other|PNE edcuation|The PNE session will last 30 minutes and will be delivered in a one-on-one educational format with a clinician using prepared images, drawings and metaphors. The 30-minute PNE session was chosen to reflect a clinically meaningful intervention in a typical allocated time frame in clinical practice. The content of the PNE is described in detail elsewhere, using a metaphors to explain various aspects of pain including sensitization of the peripheral and central nervous system (sensitive alarm system metaphor); spreading pain (nosy neighbors metaphor); increases problems with focus and concentration (brain meeting metaphor) and difficulty with fatigue and sleep (lion metaphor).
15852421|NCT04023422|Behavioral|Clinical intervention|The community health navigator will ask patient to produce medications, to indicate if there are current smokers in the home, to look for structural problems within the home, presence of pests, allergens, pollutants. Pt will be asked to produce their current medications. At the end a report will be written for the clinician.
15852422|NCT04023422|Behavioral|Feedback|The community health navigator will give the clinician real-time feedback on guideline-related health.
15852423|NCT04023409|Other|NA: no intervention|NA: no intervention
15852424|NCT04023396|Drug|ABX464|"ABX464
~All subjects will receive ABX464 administered at 50 mg o.d for an overall period of 96 weeks."
15852425|NCT04023383|Drug|40 cc HyaRegen NCH gel|After an extensive bleeding control the patients in the intervention group had 40 mL of HyaRegen NCH gel instilled into the peritoneal cavity.
15852426|NCT04023383|Drug|40 cc sterile saline solution|After an extensive bleeding control the patients in the control group had 40 cc sterile saline solution compatible with the body temperature.
15852427|NCT04023370|Device|Treatment of primary iliac artery stenosis and/or occlusive lesions|Stent implantation
15852428|NCT04023357|Other|PEEK|New polyetheretherketones material
15852429|NCT04023357|Other|Emax|standard etchable glass ceramic used for Endocrowns
15852430|NCT04023344|Drug|Humalog Mix25|Subcutaneus injections Humalog® Mix 25 twice daily during 4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses
15852431|NCT04023344|Drug|Insulin Lispro Biphasic 25|"Subcutaneus injections Insulin Lispro Biphasic 25 (Geropharm) twice daily during 4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses"
15852432|NCT04023331|Drug|67Cu-SARTATE|67Cu-labelled MeCOSar-Tyr3-octreotate
15852433|NCT04023331|Drug|64Cu-SARTATE|64Cu-labelled MeCOSar-Tyr3-octreotate
15852434|NCT04023318|Behavioral|Integrated Lifestyle Intervention|This program is grounded in data demonstrating the dysregulation across multiple domains and considerable life stressors experienced by this population. The central hypothesis is that by simultaneously ameliorating psychological dysregulation and directly targeting proinflammatory behaviors, ILI operates on multiple proposed mediators of poor treatment outcomes in this population, thereby enhancing treatment outcomes. As such, the overall framework emphasizes integration of self-regulation as it applies to both psychological functioning and weight control. Content will highlight the interconnectedness of mood, stress, eating and exercise behaviors, and risk for inflammation and disease. Each treatment session will present a combination of behavioral and psychological content, representing a truly integrated approach. Participants will meet for 75-minute group sessions weekly for months 1-2, followed by bi-weekly groups in months 3-4, for a total of 12 groups.
15852435|NCT04023305|Drug|Deep sedation by Sevoflurane on the Morphotype of ARDS in ICU patieNts|Pharmacokinetic of inhaled sevoflurane used for sedation
15852436|NCT04023292|Drug|Endocrine therapy|Use before surgery for 2 weeks. Choice of endocrine therapy is according to guidelines and centre policy.
15852437|NCT04023292|Drug|Endocrine therapy|Use before surgery for 4 weeks. Choice of endocrine therapy is according to guidelines and centre policy.
15852438|NCT04023279|Other|TENS|100 Hz and 100 usec for 20 minutes
15852439|NCT04023279|Other|Myofascial therapy|Seven to fifteen transverse sliding repetitions and three repetitions of longitudinal sliding of myofascial release therapy
15852440|NCT04023266|Drug|Intravenous N-Acetylcysteine|Intravenous N-acetyl cysteine bolus and infusion as described in the experimental arm.
15852441|NCT04023253|Drug|Mirabegron|Mirabegron 25 mg
15852442|NCT04023253|Drug|Solifenacin|Solifenacin 5 mg
15852443|NCT04023240|Drug|68Ga-FAPI|"68Ga-FAPI is quinoline based PET radiopharmaceutical.
~68Ga-FAPI is administered intravenously (IV)"
15852444|NCT04023240|Procedure|Computed Tomography (CT) scan|Participants will have a CT scan for attenuation correction and anatomic localization of PET data.
15852445|NCT04023240|Procedure|Positron Emission Tomography (PET) scan|PET images will be acquired.
15852446|NCT04023227|Drug|Sacubitril/valsartan|50 (24/26) mg, 100 (49/51) mg and 200 (97/103) mg will be available for dose adjustments.
15852447|NCT04023227|Drug|Enalapril|5 mg and 10 mg will be available for dose adjustments.
15852448|NCT04023214|Diagnostic Test|Peripheral (digital) arterial tonometry|This will be measured using the EndoPAT system (Itamar Medical)
15852449|NCT04023201|Other|Nocturnal symptoms|Parkinson's disease patients with or without nocturnal symptoms
15852450|NCT04023175|Other|Telemedicine preoperative counseling|The telemedicine visit will be completed using an Atrium Health approved virtual visit platform.
15852451|NCT04023175|Other|In office preoperative counseling|This includes our standard preoperative counseling located at the Women's Center for Pelvic Health
15852452|NCT04023162|Behavioral|Operant conditioning|Active participation of respondents, Overcoming and eliminating negative behaviors, Encouraging positive behavior in pain, Overcoming the fear of the movement, Motivation to implementation pre-set specific goals.
15852453|NCT04023162|Behavioral|Therapy Exercises in Group|Aerobic exercises, Stretching exercises and flexibility, Range of motion, Balance and coordination, Breathing exercises Stabilization exercises Muscle strength training exercises
15852454|NCT04023162|Behavioral|Back School|Basic information on low back pain - anatomy, physiology, causes, treatment. Correct postures - standing, sitting, driving, sleeping, Correct body movements - lifting, pushing, walking.
15852455|NCT04023149|Drug|recombinant human interleukin-2 (rhIL-2)|Drug: rhIL-2; Pharmaceutical form: solution; Route of administration: oral gargle.
15852456|NCT04023149|Drug|placebo|Drug: placebo; Pharmaceutical form: solution; Route of administration: oral gargle.
15852457|NCT04023136|Procedure|partial hepatectomy by laparotomy on healthy or pathologic parenchyma.|Preoperative flow and MRI + intraoperative measures of flow and pressures
15852471|NCT04023032|Behavioral|multicomponent cognitive intervention|"The intervention takes place in groups of 6-10 participants and is leaded by one occupational therapist. It includes 16 sessions, 90 minutes each.
~The first part of each session starts with a 15-minute review of previous homework or relaxation. The second part, which lasts 35 minutes, involves structured training with activity-sheets, board games, role-playing and computerized games. The third part, which lasts 30 minutes, is the lifestyle interventions. The instructor explains the generalization of the previous activities toward daily life, and introduces healthy lifestyles. Through group discussions, the therapist guides participants to develop solutions and strategies for their memory or cognition-related problems and application to daily life. The last 10 minutes are used to suggest homework."
15852472|NCT04023019|Biological|Nuwiq|Nuwiq is a recombinant FVIII concentrate from a human cell line. It is administered via intravenous injection at a dosage determined by the investigator's discretion, in consideration of the participants' clinical condition and prescribing information.
15852473|NCT04023019|Biological|Octanate|Octanate is a high-purity human Factor VIII / von Willebrand Factor (VWF) concentrate. It is administered via intravenous injection at a dosage determined by the investigator's discretion, in consideration of the participants' clinical condition and prescribing information.
15852474|NCT04023019|Biological|Wilate|Wilate is a high-purity human von Willebrand Factor (VWF)/Factor VIII concentrate. It is administered via intravenous injection at a dosage determined by the investigator's discretion, in consideration of the participants' clinical condition and prescribing information.
15852475|NCT04023019|Biological|Emicizumab|Emicizumab is a therapeutic antibody which brings activated factor IX and factor X together It is administered via subcutaneous injection at a dosage determined by the investigator's discretion, in consideration of the participants' clinical condition and prescribing information.
15852476|NCT04023019|Biological|Recombinant factor VIIa (rFVIIa)|Recombinant factor VIIa (rFVIIa) is a blood factor VII manufactured using recombinant technology. It is administered via intravenous injection at a dosage determined by the investigator's discretion, in consideration of the participants' clinical condition and prescribing information.
15852477|NCT04023019|Biological|Activated prothrombin complex concentrate (aPCC)|Activated prothrombin complex concentrate (aPCC) is an anti-inhibitor coagulant complex acting on multiple pathways to facilitate coagulation. It is administered via intravenous injection at a dosage determined by the investigator's discretion, in consideration of the participants' clinical condition and prescribing information.
15852478|NCT04023006|Device|Removable prostheses|Full dentures created by Additive manufacturing (Carbon Printers)
15852479|NCT04022993|Drug|Lantus Solostar, 100 Units/mL Subcutaneous Solution|4 weeks of glucose-level based dose titration, 22 weeks of treatment with stable doses
15852480|NCT04022993|Drug|Insulin RinGlar, 100 Units/mL Subcutaneous Solution|4 weeks of glucose-level based dose titration, 22 weeks of treatment with stable doses
15852482|NCT04022967|Drug|dolutegravir|One daily tablet (50mg) during 96 weeks
15852483|NCT04022967|Drug|atazanavir boosted with ritonavir|One daily tablet with atazanavir (300 mg) boosted with ritonavir (100 mg) during 96 weeks
15852484|NCT04022967|Drug|tenofovir + lamivudine +efavirenz|One daily tablet with tenofovir 245 mg + lamivudine (300 mg) + efavirenz (400 mg) during 96 weeks
15852485|NCT04022967|Drug|Lamivudine|One daily tablet (300mg) during 96 weeks
15852486|NCT04022954|Device|Catheter ablation|Inquiry AFocusII Double Loop and Advisor HD Grid, Sensor Enabled
15852487|NCT04022941|Drug|Sodium Benzoate|Group A will receive drug packets containing 2.5 gm sodium benzoate and 5 gm powdered table sugar for 5 days.
15852488|NCT04022941|Other|Powdered table sugar as palcebo|Group B will receive 7.5 gm packets of powdered table sugar for 5 days as placebo which is similar in appearance and taste as sodium benzoate.
15852489|NCT04022928|Other|PRP|, For PRP preparation, specialized platelet concentrate separator containing acid citrate dextrose as anticoagulant and a specific separator gel that harvest PR, preventing contamination of red blood cells and leukocytes were used.
15852490|NCT04022915|Drug|64Cu-FBP8|Up to 10 mCi (millicurie) 64Cu-FBP8 will be administered to each subject.
15852491|NCT04022915|Diagnostic Test|PET-CT imaging|All subjects will undergo PET-CT imaging after administration of 64Cu-FBP8.
15852492|NCT04022902|Other|No intervention|This is an exploratory qualitative study to understand the needs of patients with pneumoconiosis, and the care-giving experience of their family caregivers.
15852493|NCT04022889|Device|INTERCEPT Treated Platelets|Apheresis platelet components in 100% plasma collected using the Trima separator, prepared with the INTERCEPT Blood System for Platelets (Test Platelets) and stored for 7, 6 or 5 days at 20°C-24°C with continuous agitation. Samples from the Test component will be processed with either the BEST or the Variant 1 procedure prior to radiolabeling. The radiolabeled autologous Test and Control platelets will be simultaneously administered intravenously into the subject.
15852494|NCT04022876|Drug|ALRN-6924|ALRN-6924 administered IV on Days 0-2 prior to carboplatin and pemetrexed administered IV on Day 1 of every 21-day cycle.
15852495|NCT04022876|Drug|Carboplatin|Carboplatin administered IV on Day 1 of every 21-day cycle.
15852496|NCT04022876|Drug|Pemetrexed|Pemetrexed administered IV on Day 1 of every 21-day cycle.
15852497|NCT04022876|Drug|Placebo|Placebo administered IV on Days 0-2 prior to carboplatin and pemetrexed administered IV on Day 1 of every 21-day cycle.
15852498|NCT04022876|Drug|ALRN-6924|ALRN-6924 administered IV on Days 0-4 prior to topotecan administered IV on Days 1-5 of every 21-day cycle.
15852499|NCT04022876|Drug|Topotecan|Topotecan administered IV on Days 1-5 of every 21-day cycle.
15852500|NCT04022863|Diagnostic Test|TEP|Tumor Educated Platelets
15852501|NCT04022863|Diagnostic Test|ctDNA|circulating tumor DNA
15852502|NCT04022850|Behavioral|Intuitive de-implementation|A set of de-implementation strategies targeting automatic cognition to alter the clinical decision making of physicians regarding the CVD primary prevention practice to be performed with hypercholesterolemic patients aged 40-75 years old without ischemic heart disease or diagnosed cardiovascular disease and with low CVD risk (<5%)
15852536|NCT04022590|Device|E-clothes|The E-clothes could prove heart rate or heart rate variability(HRV) information to the participants' smart phone by blue tooth. Then the smart phone will calculate and provide the suitable aerobic training intensity by the microphone when the participants do aerobic training.
15852503|NCT04022850|Behavioral|Reflexive de-implementation|A set of de-implementation strategies targeting reflexive cognition to alter the clinical decision making of physicians regarding the CVD primary prevention practice to be performed with hypercholesterolemic patients aged 40-75 years old without ischemic heart disease or diagnosed cardiovascular disease and with low CVD risk (<5%)
15852504|NCT04022850|Behavioral|Passive dissemination|Usual procedures of dissemination of clinical practice guidelines, focused in the distribution of materials, support tools and training in the reference group.
15852505|NCT04022837|Drug|Pantoprazole 40mg|effect of this drug on renal function
15852506|NCT04022824|Other|OSA|Patients with OSA (apnea hypopnea index ≥15) based on sleep study
15852507|NCT04022824|Other|Non-OSA|Patients without OSA (apnea hypopnea index <15) based on sleep study
15852508|NCT04022811|Drug|0.1% bromfenac|the patients received the use of the Ponacore 3 days before and 7 days after the operation. Local eye drops, 2 times a day.
15852509|NCT04022798|Other|Exercise, manual therapy|"Participants were randomly assigned into treatment (n=15) or control group (n=15). Participants in each group received 12 treatment sessions of 45 minutes each, 2 days a week for 6 consecutive weeks.
~For each group, a menu of a lumbar stabilization program was designed. This program included 8 levels of exercise ( single leg knee to chest stretch, double leg knee to chest, supine piriformis stretch, supine hamstring stretch, lower trunk rotation stretch, lumbar rotation stretch, pelvic tilt, pelivic tilt with alternative legs). Exercises were tailored for each individual ability and, if possible, progressed at each session which would last approximately 30 minutes. Each single exercise was repeated many times based on the patient's clinical condition. All sessions were provided by physiotherapists."
15852510|NCT04022785|Drug|Azacitidine|Given IV or SC
15852511|NCT04022785|Drug|BRD4 Inhibitor PLX51107|Given PO
15852512|NCT04022772|Other|Best Practice|Receive standard of care
15852513|NCT04022772|Other|Medical Chart Review|Ancillary studies
15852514|NCT04022772|Other|Quality-of-Life Assessment|Ancillary studies
15852515|NCT04022772|Other|Questionnaire Administration|Ancillary studies
15852516|NCT04022772|Procedure|Supportive Care|Participate in PACK Health program
15852517|NCT04022759|Behavioral|Treatment as Usual with Security Prime|"In addition to their treatment as usual (low-intensity guided self-help behavioural activation for depression), participants will complete an initial attachment security priming task during the first session with their allocated clinician. Participants will be prompted in their intervention workbook with a caption regarding what a secure attachment relationship represents. They will be asked to think of a person/ people with whom they feel they have this relationship, and list them. Following this, they are asked to plot these individuals on a diagram of concentric circles in relation to how close they feel this person is to them. The closer to the middle of the diagram the individual places each person, the closer they feel their relationship to that person is.
~Prior to each session with their clinician, they will be prompted to complete a repeated security priming task in order to increase feelings of security prior to therapy sessions."
15852518|NCT04022759|Behavioral|Treatment as Usual (Behavioural Activation)|Clients will engage in treatment as usual. This involves low-intensity guided self-help behavioural activation for depression.
15852519|NCT04022746|Procedure|Magnetic Resonance Elastography|Undergo multiparametric MRI/MRE
15852520|NCT04022746|Procedure|Magnetic Resonance Imaging|Undergo multiparametric MRI/MRE
15852521|NCT04022733|Drug|Moderate neuromuscular block|maintaining of moderate neuromuscular block (train-of-four count 1-2) during surgery, reversal using neostigmine 50 ug/kg and glycopyrrolate 10 ug/kg
15852522|NCT04022733|Drug|Deep neuromuscular block|maintaining of deep neuromuscular block (posttetanic count 1-2) during surgery, reversal using sugammadex 4 mg/kg based on actual body weight
15852523|NCT04022720|Procedure|Platelet Rich Fibrin Application|Platelet Rich Fibrin application at first post-op visit.
15852524|NCT04022707|Other|High-speed circuit resistance training|The program will include three circuits of 11 exercises that target the upper and lower body. Training will gradually increase over the first three week from 1 to 3 circuits.
15852525|NCT04022707|Other|Educational control|Lectures on health and fitness
15852526|NCT04022694|Behavioral|Exposure to beverage health information|Red stop sign and avoidance message for sugar-sweetened beverages and green check mark and promotion message for non-sugar-sweetened beverage nutrition information
15852527|NCT04022694|Behavioral|Exposure to beverage calorie information|Calories for sugar-sweetened and non-sugar-sweetened beverages
15852528|NCT04022681|Other|BALLETS|Cohort were not exposed to any intervention. There information will be analysed from database searches.
15852529|NCT04022668|Radiation|Coronary angiogram|Routine coronary angiogram, if indicated
15852530|NCT04022655|Other|ICU Care|No intervention
15852531|NCT04022642|Other|High-Intensity Interval Training|"The program will be applied in the first 10-15 minutes of each PE class, twice a week, including a brief warm-up, ranged from 14 to 20 intervals, adopting a 2:1 work to rest ratio (ie, 30-s work, followed by 30-s rest)
~A cut-point of >=90% of maximal heart rate was used as our criterion for satisfactory compliance to high-intensity exercise
~In order to estimate effort, fatigue and training load, a subjective effort scale will be used throughout each session. The heart rate will be monitored throughout the session in real time through Bluetooth technology.
~Actigraph accelerometers (wGT3X-BT), randomly distributed by the students in each session, will be used to characterize the intensity of the sessions."
15852532|NCT04022629|Procedure|Arthroscopic Washout Only|To wash out the shoulder joint with a sterile solution through an arthroscope (keyhole surgery) under a general anaesthetic.
15852533|NCT04022629|Procedure|Arthroscopic Bankart Repair|To repair the torn glenoid labrum in the shoulder, using key-hole (arthroscopic) surgery techniques under general anaesthetic. The Bankart technique is well described and will be performed using suture anchors.
15852534|NCT04022616|Other|Specimen collection|Specimens are obtained from patients who are being treated for breast malignancies.
15852535|NCT04022603|Device|Cyclometer Ergometer|The measurements are carried out on a max effort of 12 minutes on a cyclometer ergometer with a constant load (Motomed viva2 light). A first effort is made with a Venturi type mask whose Inspired Fraction in Oxygen (FiO2) is set for a pulsated oxygen saturation (SpO2) greater than or equal to 85%, and then a second at 2h interval with high-throughput googles (Optiflow) with the corresponding FiO2.
15853491|NCT04014842|Device|RapidShock|Use of the Reconfirmation Analysis Mode algorithm
15852537|NCT04022590|Behavioral|Healthy consultation|Healthy consultation will educate the participants do aerobic training three times a week for 3 months. And the each training period is at least 30 minutes.
15852538|NCT04022577|Behavioral|Adherence Therapy|Motivational interviewing-based AT in this study was based on Gray et al.'s eight-session AT using the motivational interviewing technique (and principles of cognitive behavioral therapy).
15852539|NCT04022577|Behavioral|control group|The control group received routine care
15852540|NCT04022538|Procedure|Anterior maxillary vertical segmental sandwich osteotomy with simultaneous implant placement|"Following the Sandwich Osteotomy procedure described in the study description, the following steps will be done:
~The first implant osteotomy will be prepared and placed while a chisel is placed between the down fractured segment and the basal bone, and then the second implant will be installed.
~The gap between the transported segment and the basal bone will be filled with xenograft particulate bone substitute.
~Finally, periosteal scoring will be done to allow tension-free interrupted closure using 3-0 vicryl suturing material."
15852541|NCT04022538|Procedure|Anterior maxillary vertical segmental sandwich osteotomy using micro-plates fixation|"Following the Sandwich Osteotomy procedure described in the study description, the following steps will be done:
~The created gap between the transported segment and the basal bone will be filled with xenograft particulate bone substitute.
~The mobilized segment is to be fixed to the basal bone using micro-plates and micro-screws.
~Finally, periosteal scoring will be done to allow tension-free interrupted closure using 3-0 vicryl suturing material."
15852542|NCT04022525|Drug|Leflunomide 20Mg Tab|blood samples of rheumatoid patients will be collected for SNPs detection and drug assay
15852543|NCT04022512|Radiation|computed tomography|thoracic CT examinations for pre-treatment staging and/or subsequent post-treatment follow-up.
15852544|NCT04022499|Behavioral|Presessions|"The Pre-NDPP arm includes a pre-session with three components: 1) education about diabetes risks, 2) motivational interviewing (MI) to encourage participation in the NDPP and, 3) problem-solving of barriers to engagement."
15852545|NCT04022499|Behavioral|National Diabetes Prevention Program|The Diabetes Prevention Program was a successful clinical trial demonstrating that intensive lifestyle support for weight loss reduced diabetes incidence by 58%. The intervention was translated into the National Diabetes Prevention Program (NDPP) and disseminated by the Centers for Disease Control and Prevention as a yearlong group-based program since 2012.
15852546|NCT04022486|Other|Incidence, management and risk factors of seizure|Incidence of seizure, management (treatment, paraclinical examinations) and risk factors of seizure in children admitted for severe bronchiolitis
15852547|NCT04022473|Drug|Bafiertam|Over-encapsulated capsule to mask treatment
15852548|NCT04022473|Drug|Tecfidera|Over-encapsulated capsule to mask treatment
15852549|NCT04022460|Diagnostic Test|Video clip assessment|Parents will take short video clips of their child sleeping at night. They will be asked to review the video clips and rate whether they think their child has obstructive sleep apnea (OSA), and if so, how severe it is. Two clinicians will review the video clips on a separate night.
15852550|NCT04022460|Diagnostic Test|Polysomnography (sleep study)|Children will undergo a polysomnography as the gold standard test to assess for OSA.
15852551|NCT04022460|Other|Educational webinar|After evaluating the video clips of their child sleeping, parents will watch an educational webinar on OSA in children with Down syndrome and how to recognize symptoms.
15852552|NCT04022447|Drug|Dupilumab|retrospective data collection
15852553|NCT04022434|Dietary Supplement|Placedo|Subjects will mix the placebo in the beverage of their choice and consume this approximately 20 minutes before meals or snacks, in according with the dosing guidelines set for them by the dietitian.
15852554|NCT04022434|Dietary Supplement|Alanine|Subjects will mix the alanine in the beverage of their choice and consume this approximately 20 minutes before meals or snacks, in according with the dosing guidelines set for them by the dietitian.
15852555|NCT04022421|Drug|Hydroxychloroquine|the drug will be taken by one group of the patients daily at a dose of 400mg
15852556|NCT04022408|Diagnostic Test|Liquid based cytology|Liquid based cytology
15852557|NCT04022408|Diagnostic Test|Conventional cytology|Conventional cytology
15852558|NCT04022395|Diagnostic Test|stress cardiac MRI|pharmacological stress testing has evolved as an alternative to physical exercise for the detection of inducible myocardial ischemia
15852559|NCT04022382|Device|Restylane Defyne|Restylane is a gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE, stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL.
15852560|NCT04022369|Behavioral|Exercise Group|The intervention group received 45-60 minute of individual training and a handbook for the exercise program was given. These patients were followed for a total of 12 weeks. The weekly motivational phone calls structured according to the empowerment model and home visits when necessary were repeated. The exercise program was developed by reviewing the literature part on physical activity for senior citizens with heart failure. The program was established on evidence-based recommendations for the cardiac rehabilitation of patients with HF. Each session included warm-up and cool-down exercises, moderate walking, and balance exercises.
15852561|NCT04022356|Device|Feetme Connected Soles|"Walk for 10 meters (and 30meters):
~By wearing the European Community (EC) labelled connected soles in patient's shoes, triggered by smartphone- collection of data by smartphone
~By being filmed by a camera camera mounted on a tripod (excluding the face) for steps counting (2 observers).
~If there is a technical problem during the walk test, this one can be performed 1 time again 1 hour after initial test.This is expected to happen very rarely."
15852562|NCT04022343|Drug|Cabozantinib|Given PO
15852563|NCT04022330|Other|Blood sampling|The blood sampling will be done just before surgery
15852564|NCT04022317|Biological|Biocon Insulin R|Biocon Insulin R is a short-acting human insulin, produced by recombinant deoxyribonucleic acid (rDNA) technology utilizing Pichia pastoris (yeast).
15852565|NCT04022317|Biological|Humulin®R|Humulin® R is a polypeptide hormone structurally identical to human insulin synthesised through recombinant deoxyribonucleic acid (rDNA) technology in a non-pathogenic laboratory strain of Escherichia coli bacteria.
15852566|NCT04022304|Biological|Biocon Insulin N|Biocon Insulin N is an intermediate-acting isophane suspension of human insulin produced by recombinant deoxyribonucleic acid(rDNA) technology utilizing Pichia pastoris (yeast).
15854698|NCT04004715|Dietary Supplement|Whey Protein|commercially available whey protein isolate
15852567|NCT04022304|Biological|Humulin® N|Humulin® N (human insulin [recombinant deoxyribonucleic acid origin] isophane suspension) is an intermediate-acting human isophane insulin. Humulin® N is a suspension of crystals produced from combining human insulin and protamine sulphate.
15852568|NCT04022291|Biological|Humulin ®70/30|"Humulin® 70/30 is a premixed suspension of human insulin of recombinant deoxyribonucleic acid (rDNA)origin, which contains 30% short-acting human soluble insulin and 70% intermediate-acting isophane insulin.
~Human insulin is produced by recombinant deoxyribonucleic acid (rDNA), technology utilizing a non-pathogenic laboratory strain of Escherichia coli."
15852569|NCT04022291|Biological|Biocon Insulin 70/30|"Biocon Insulin 70/30 is a premixed suspension of human insulin of recombinant deoxyribonucleic acid (rDNA)origin, which contains 30% short-acting human soluble insulin and 70% intermediate-acting isophane insulin.
~Biocon insulin is produced by recombinant deoxyribonucleic acid (rDNA) technology utilizing a non-pathogenic laboratory strain of Escherichia coli."
15852570|NCT04022265|Device|implant placement|Full-thickness muco-periosteal flaps will be elevated, and the alveolar bone exposed to prepare the bed for the implant installation
15852571|NCT04022252|Device|Cheese dental laser|810 nm GaAlAs diode laser device
15852572|NCT04022252|Device|OrthoPulse|850 nm LED (light emitting diode)
15852573|NCT04022252|Other|Placebo|810 nm GaAlAs diode laser device
15852574|NCT04022239|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo stem cell transplantation
15852575|NCT04022239|Drug|Bendamustine|Given IV
15852576|NCT04022239|Drug|Cyclophosphamide|Given IV
15852577|NCT04022239|Biological|Filgrastim-sndz|Given SC
15852578|NCT04022239|Drug|Fludarabine|Given IV
15852579|NCT04022239|Drug|Melphalan|Given IV
15852580|NCT04022239|Drug|Mycophenolate Mofetil|Given PO
15852581|NCT04022239|Biological|Rituximab|Given IV
15852582|NCT04022239|Drug|Tacrolimus|Given IV and PO
15852583|NCT04022239|Radiation|Total-Body Irradiation|Undergo TBI
15852584|NCT04022226|Drug|Ketamine|Induction agent that suppresses infra-slow waves
15852585|NCT04022226|Drug|Methohexital|Induction agent that does not suppress infra-slow waves
15852588|NCT04022200|Device|Paclitaxel DCB|The length of the DCB catheter should be chosen to exceed the target lesion for at least 2mm (at both proximal and distalends). The catheter(s) will be inflated for 30 to 60s with a minimum of 7 atm. Predilation of the diseased coronary segment with a uncoated balloon/scoring balloon/cutting balloon before the use of DCB will be encouraged. DES should be implanted if the angiographic result after DCB alone therapy is not satisfactory due to significant recoil/residual stenosis or dissection (Type C-F).
15852589|NCT04022187|Other|Observational study : no intervention|Observational study : no intervention, only exporting data
15852590|NCT04022174|Behavioral|Moderate dosage training of action Observation and Motor imagery|Motor imagery and action observation of orofacial exercises with moderate dosage
15852591|NCT04022174|Behavioral|Intensive dosage training of action observation and motor imagery|Motor imagery and action observation of the orofacial exercises with intensive dosage
15852592|NCT04022174|Biological|Intensive dosage orofacial exercises|Orofacial exercises with high intensity
15852593|NCT04022174|Behavioral|Moderate dosage orofacial exercises|Orofacial exercises with moderate intensity
15852594|NCT04022161|Drug|Nitrogen Gas for Inhalation|See arm description
15852595|NCT04022161|Other|Blood withdrawal|Blood samples will be collected over four time-points: (I) baseline (before surgery) (II) end of the surgery, (III) end of 24 hours of gas delivery and (IV) 24 hours from the gas suspension.
15852596|NCT04022161|Drug|Nitric Oxide|See arm description
15852597|NCT04022148|Biological|Gardasil|Experimental arm: Vaccine group VS Control arm: Non-Vaccine group
15852598|NCT04022135|Dietary Supplement|Folic acid|Participants will supplement with 0.6mg/day for 16 weeks.
15852599|NCT04022135|Dietary Supplement|(6S)-5-methyltetrahydrofolic acid|Participants will supplement with 0.625mg/day for 16 weeks.
15852600|NCT04022122|Procedure|Usual Care follow-up in a heart failure program.|Standard follow-up involves hospital and primary care for HF patients. In this context, physicians and nurses experienced in the care and management of HF direct care. HF care is based on 1) active detection of newly admitted HF patients, 2) planned educational interventions to improve self-care, 3) completion of a comprehensive psychosocial assessment of patients and caregivers, 4) discharge planning and home transition coordination involving the hospital HF team and Primary Care teams, 5) structured and planned evidence-based follow-up shortly after discharge from hospital.
15852601|NCT04022109|Device|Breath sampling for VOC detection|Breath sampling will be performed by using a special sensor device and or GC-MS analysis (by collecting breath samples in adsorbent tubes). Pepsinogen testing will be used in a subgroup to identify serological increased risk for atrophy
15852602|NCT04022109|Procedure|Surgery material collection for VOC headspace analysis|Only for gastric cancer patients undergoing surgery (Group 1)
15852603|NCT04022109|Diagnostic Test|Upper endoscopy|Routine endoscopic evaluation with a standard biopsy work-up according to updated Sydney system. Additional gastric contents for GC-MS and microbiota analysis in a subgroup. Endoscopy will be used only according to the clinical indications (in Group 4 - according to the results of pepsinogen tests)
15852604|NCT04022109|Diagnostic Test|Microbiota testing|Faecal and gastric contents and biopsy samples for microbiota testing
15852605|NCT04022096|Drug|Tegoprazan 25mg QD|Tegoprazan 25mg tablets will be orally administered, once daily, for up to 6 months.
15852606|NCT04022096|Drug|Lansoprazole 15mg QD|Lansoprazole 15mg capsules will be orally administered, once daily, for up to 6 months.
15852607|NCT04022070|Other|Dynamic Tape® (Tape)|To evaluate the evolution of this symptomatology prior to and thereafter the application of Dynamic Tape® bandage affected by plantar fasciitis during a week the Outcome Measure, pain is evaluate with a VAS (visual pain scale).
15852608|NCT04022057|Drug|Ropivacaine injection|Local anesthetic injection
15852609|NCT04022057|Drug|Dextrose 5|Sham Injection
15852610|NCT04022044|Behavioral|Observational group|
15852611|NCT04022031|Drug|Chinese patent medicine|Shexiang Baoxin Pill, Tongxinluo Capsule, Tongmai Yangxin Pill, Xuefu Zhuyu Capsule, Qishen Yiqi Dropping Pill.
15852612|NCT04022018|Radiation|Adaptive radiotherapy|CT repositioning will be performed after 15fractions of external radiotherapy, then new target volume will be contoured and new radiotherapy plan will be formulated with the assistance of artificial intelligence program. New radiotherapy plan will be performed from the 17th fraction external radiotherapy.
15852613|NCT04022018|Radiation|no adaptive radiotherapy|Concurrent external volumetric rotational intensity modulated radiotherapy and chemotherapy followed by image-guided adaptive brachytherapy is the treatment strategies of control group patients
15852614|NCT04022005|Drug|Chidamide, Rituximab, Gemcitabine,Oxaliplatin|"All patients enrolled in the study will accept Chidamide + R-GemOx (Rituximab, Gemcitabine and Oxaliplatin) as their salvage chemotherapy.
~Patients with CR or PR will receive chidamide maintenance therapy."
15852615|NCT04021992|Drug|gemcitabine, vinorelbine and doxorubicin liposome, with or without rituximab|All patients enrolled in the study will accept gemcitabine, oral vinorelbine and doxorubicin liposome, with or without rituximab as their salvage chemotherapy.
15852616|NCT04021979|Dietary Supplement|Enteral Nutrition Powder Ensure|Enteral Nutrition Powder Ensure for each meal.The duration of study is one day before colonoscopy.
15852617|NCT04021979|Drug|1.5L PEG|Low volume PEG
15852618|NCT04021979|Other|Self-controlled diet|Self-controlled low residue diet.
15852619|NCT04021979|Drug|2L PEG|Normal volume of PEG
15852620|NCT04021966|Procedure|Vaginal laser application|"One laser treatment cycle consists of 3 vaginal laser applications with a 4-weeks interval. Each application lasts around 5 minutes.
~The vaginal laser procedure will be performed in an outpatient setting, not requiring any specific preparation, analgesia or anesthesia, by one of two experienced operators.
~A vaginal probe will be gently inserted and manually rotated to provide a 360° treatment of the vaginal mucosa."
15852621|NCT04021953|Behavioral|People Like Us Online Video Series Intervention|"People Like Us miniseries incorporates key sexual health messages to:
~Increase viewers' knowledge and perceptions of HIV and other STI risk;
~Address homophobia and sexual orientation disclosure;
~Increase safer-sex negotiation self-efficacy;
~Promote positive attitudes towards condom use and other safe sex behaviors;
~Build skills and self-efficacy for practicing safer sex;
~Provide information on HIV and other STI testing and its benefits;
~Provide information on resources for HIV/STI testing and other mental health services;
~Model appropriate behaviors around practicing safer sex.
~Each video in the six-part series ends with an educational video segment featuring the managers of Action for AIDS and Gayhealth.sg, who provide a brief synopsis of the episode and cover key points relevant to mental and sexual health for GBQ men."
15852622|NCT04021953|Behavioral|Sexual Health Pamphlet (Standard of Care)|The control group will be provided with an e-pamphlet on sexual wellness catered to GBMSM. This e-pamphlet has been developed by the National Skin Centre and Department of Sexually Transmitted Infections Clinic specifically for information on sexual wellness among GBMSM. It comprises segments on HIV/STI symptoms, etiology, information on how to seek help for HIV/STI, behavioral and biomedical methods of HIV prevention.
15852623|NCT04021940|Procedure|ULOD|ULOD
15852624|NCT04021927|Device|Ring Phototherapy|The product will be an open-faced ring device with an angular reflective surface that redirects unused light sideways onto the neonate's body illuminating previously unexposed regions where treatable bilirubin exists while protecting the baby from head roll with an inner transparent corral. This device is superior to current PT devices because it converts existing waste light into treatment efficacy while integrating into existing single overhead lamp systems avoiding the purchase of secondary devices that are expensive and create hospital system complexity and inefficiency issues.
15852625|NCT04021914|Device|EnChroma glasses|Each participant will be provided EnChroma products to use indoors over the course of two weeks in the emergency department, educational settings, and in their personal life. They will be encouraged to wear the glasses for at least 10 hours over 1-2 weeks prior to wearing them in a clinical setting to adjust to their use, and for 10 minutes before beginning patient care as per manufacturer instructions. They will be encouraged to take specific note of clinical scenarios that require the use of color vision (e.g., - rashes, tympanic membrane erythema, stool guaiac testing, etc.).
15852626|NCT04021901|Device|balloon dilatation|"The balloon catheter (BD U30) was placed through narrow ureter along the guide wire, and the balloon was pressurized to 25 atm until the bee waist sign disappeared on the balloon or the narrow section was seen under the endoscope. Dilation, expansion for 10 min, and then through the endoscope to observe the stenosis of the stenosis (stenosis of the stenosis of the visible adipose tissue)"
15852627|NCT04021888|Other|Exercise|Education of patients and their caregivers, deep breathing exercise, aerobic exercise and resistance training with elastic bands
15852628|NCT04021862|Drug|Bermekimab Monoclonal Antibody|Bermekimab 2 mL (200 mg/mL) pre-filled syringe
15852629|NCT04021862|Drug|Placebo|Placebo 2 mL pre-filled syringe
15852630|NCT04021849|Other|Face-to-face Class|The principal investigator will dictate a course about Sexual Harassment, Prevention and Sanction Policies of Cayetano Heredia Peruvian University using PowerPoint Presentation
15852631|NCT04021849|Other|Asynchronous Virtual Class|Every student will have the access to a platform with an Asynchronous Virtual Class that will use the same PowerPoint Presentation of the intervention with an audio recorded by the principal investigator
15852632|NCT04021836|Other|3d evaluation of nasolabial change|Evaluation of With vs without ala cinch suture after lefort 1 osteotomy
15852633|NCT04021810|Device|Continuous Positive Airway Pressure (CPAP) and patient education|Mask connected to a pump (CPAP machine) that forces air into the nasal passages at pressures high enough to overcome obstructions in the airways. Plus patient education.
15852634|NCT04021810|Device|Mandibular Advancement Device|Adjustable oral prosthesis which retains the lower mandible in an anterior position, thus limiting sleep apneas
15852635|NCT04021797|Device|transcutaneous vagal nerve stimulation|The transcutaneous stimulator engages the cymba conchae in the left inner ear, compared to the left earlobe in the sham stimulation condition.
15852636|NCT04021784|Device|SDS|The patient gets a SDS implanted.
15852637|NCT04021784|Device|NEMOST|The patient gets a NEMOST implanted.
15852662|NCT04021550|Drug|Telmisartan 80mg|Subjects in this group will receive 80mg/day of Telmisartan (an angiotensin receptor blocker). Treatments will be administered in pre-packaged blister packages. Subjects will take Telmisartan once per day for 6 weeks.
15852638|NCT04021771|Other|Educational Curriculum Intervention|The intervention includes: 1) Online web-based education module created with the Rise 360 platform that has ten lessons, providing the learner with an introduction, background, and a map of how to navigate a discharge conversation for patients with diagnostic uncertainty. Core content are presented with multiple interactive components such as flip-cards, multiple-choice, drag-and-drop, sketch videos, and narrated clips. 2) Mobile application game designed to facilitate practice of the content learned in the online curriculum 3) Deliberate practice sessions allow trainees to practice communication techniques presented within the online module and to receive feedback on their performance. These sessions will be conducted with standardized patients via a video platform, during a scheduled appointment.
15852639|NCT04021758|Behavioral|Peer to peer program intervention|Peer to peer suicide prevention program aimed at reducing suicide in a military population.
15852640|NCT04021745|Behavioral|App-based mindful eating|This is a mindful eating smartphone application comprised of twenty-eight modules of 10-15 minutes each designed to teach mindfulness for binge eating. The feature that is being tested will ask individuals to do a mental exercise when they're craving and will measure their satisfaction related to the experience.
15852641|NCT04021719|Other|Stakeholder feedback|Stakeholders, including OnTrackNY participants, past participants, family members, clinicians, administrators, payors and state leadership, will participate in a variety of activities to provide continuous quality improvement to the OnTrackNY program, including a Stakeholder Workgroup, interviews and focus groups
15852642|NCT04021719|Other|Data infrastructure|Data will be systematically collected as part of CQI activities, within a state-of-the-art data infrastructure that allows for client-level feedback to clients, providers and sites to improve quality of care.
15852643|NCT04021706|Drug|Anamorelin Hydrochloride|Ghrelin receptor agonist
15852644|NCT04021706|Drug|Placebo|placebo is a inert substance
15852645|NCT04021693|Other|Handheld Ultrasound Devices|Interns in the handheld ultrasound device arm shall carry a personal handheld ultrasound device to be used for self-directed learning
15852646|NCT04021680|Other|pre-eclampsia screening program|This screening program included the use of ultrasound, biomarkers and maternal factors in calculating the risk of developing preeclampsia.
15852647|NCT04021667|Other|educational intervention|İndividual and Group Breastfeeding Education:It was taken into consideration that mothers and fathers who do not have breastfeeding experience in the antenatal period feel better in terms of their perception of the education given, and education is provided with adult education principles.Breastfeeding training slides, cloth nipple model, dummy dolls were used during the training and lecture, demonstration and application and breastfeeding training were provided.At the end of the training, they were given time to ask questions and their feedback was received.Control Group:Routine procedures in the clinic were performed for the mother and father candidates.The data of the mother and father who came to the hospital for antenatal follow-up and control were collected in four stages.
15852648|NCT04021654|Procedure|Data collection|Data collection of growth, neuromotor, sensorial, behavioral, and cognitive development.
15852649|NCT04021641|Diagnostic Test|Speech recognition in noise|Measurement of speech recognition performance in noise
15852650|NCT04021628|Other|No intervention- not applicable|No intervention - not applicable
15852651|NCT04021615|Other|Comprehensive physical therapy rehabilitation program combined with inspiratory muscle training|A threshold inspiratory muscle trainer will be connected to the artificial airway with 15 mm and 22 mm adaptors. Training bouts consist of three to five sets of six repetitions breathing through the trainer. Training will be conducted with the patient in bed with an approximately 30° head-up tilt and with intensity about 40 %- 50 % of maximal inspiratory pressure. Patients will be returned to mechanical ventilation for rest between training sets as needed. Three to five sets of six training breaths will be completed for a total of 18 to 30 training breaths per session. Following each training set, the patient indicated a rating of perceived inspiratory exertion on modified Borg scale . The study group will also receive comprehensive rehabilitation program consist of upper-extremity exercises, lower extremity exercises, pedaling exercises, trunk control exercises and bedside functional training
15852652|NCT04021615|Other|Traditional chest physical therapy rehabilitation program combined with inspiratory muscle training|The same inspiratory muscle training for the study group combined with the traditional physical therapy program consist of positioning , modified postural drainage , percussion , vibration.
15852653|NCT04021602|Behavioral|Diabetes Prevention Program|Phase 1 (core curriculum) of the Diabetes Prevention Program consists of 16 sessions and will take place during Week 18 of pregnancy through Week 33. Participants will receive the DPP curriculum via virtual pre-recorded sessions to which participants will have access. A research coordinator will follow up with each study participant by phone once weekly. If participants do not make adequate progress, the coordinator will assess how much extra time the participant will need to complete each session and will work with the participant if needed. Phase 2 (post-core curriculum) consists of 6 sessions and will be completed after delivery, between Week 6 and Week 20 postpartum. Participants will re-engage into the DPP with an orientation session at Week 6 postpartum. The same session completion format and procedure for inadequate progress will be followed as during pregnancy.
15852654|NCT04021602|Behavioral|Breastfeeding Education|Participants will receive a 2-hour session on breastfeeding and participate in a professional peer support group. The breastfeeding session is between Week 20 and Week 36 of pregnancy and will be taught by an International Board Certified Lactation Consultant (IBCLC). Participants will be provided with a breastfeeding assessment at Days 3 and 10; Week 3 and 6; and Months 2, 3, and 6 postpartum.
15852655|NCT04021602|Behavioral|Usual Care|Participants will receive regular prenatal care provided by their physician. At delivery, all participants will receive some type of lactation support in the hospital.
15852656|NCT04021589|Drug|Weileshu|a probiotics products which help to rebuild homeostasis of gut microbiome
15852657|NCT04021589|Drug|Chemotherapy|chemotherapy
15852658|NCT04021576|Other|preventative training program|complementary training of leg-, hip- and core-strength/stability
15852659|NCT04021563|Drug|SR419|Ascending single and multiple doses of SR419 orally
15852660|NCT04021563|Drug|Placebo|Ascending single and multiple doses of placebo orally
15852661|NCT04021550|Device|Continuous Positive Airway Pressure CPAP|All subjects will be advised to use their continuous positive airway pressure (CPAP) in accordance to their physician's guidelines.
15857399|NCT03983252|Drug|[F-18]PBR06|PET radiopharmaceutical
15852663|NCT04021550|Dietary Supplement|Alpha-Lipoic Acid 600mg|Subjects in this group will receive 600mg/day of Alpha-Lipoic Acid (an antioxidant). Treatments will be administered in pre-packaged blister packages. Subjects will take Alpha-Lipoic Acid once per day for 6 weeks.
15852664|NCT04021550|Other|Microcrystalline Cellulose|Subjects in this group will receive two capsules of Microcrystalline Cellulose (placebo). Treatments will be administered in pre-packaged blister packages. Subjects will take placebo pills once per day for 6 weeks.
15852665|NCT04021537|Device|non-invasive nerve stimulation|Electrical stimulation will be provided via a TENS unit.
15852666|NCT04021524|Drug|Benzoyl Peroxide 10% Bar|Patients will wash with Benzoyl Peroxide 10% Bar
15852667|NCT04021524|Drug|Chlorhexidine Gluconate|Patients will wash with Chlorhexidine Gluconate
15852668|NCT04021511|Other|OAR application by a nurse|As per protocol, in the Phase B, nurses will be allowed to apply OAR which can lead to an early radiography prescription.
15852669|NCT04021498|Drug|Simvastatin 40mg|phase III, triple-blind randomised placebo-controlled trial comparing simvastatin 40 mg/day versus placebo (lactose). One hundred and fifty eight patients with recurrent AP (at least 2 episodes) will be included (79 per arm of treatment). Treatment and follow-up will last for 12 months.
15852670|NCT04021498|Other|Placebo|phase III, triple-blind randomised placebo-controlled trial comparing simvastatin 40 mg/day versus placebo (lactose). One hundred and fifty eight patients with recurrent AP (at least 2 episodes) will be included (79 per arm of treatment). Treatment and follow-up will last for 12 months.
15852671|NCT04021485|Other|neurodevelopmental assessment|"As part of the usual follow-up of premature children, a follow-up consultation is planned around the age of 3 years. During this visit, a neurodevelopmental assessment will be carried out for the Betanino study. The duration of this evaluation is evaluated around 3h in total.
~Interventions will include:
~Standardized neurological exam
~Morphometric measurements including height, weight, head circumference
~Blood pressure measurement
~Multiple aspects of cognition using ancillary indexes of WPPSI-IV subtests, NEPSY subtests and KABC-II (Kaufman Assessment Battery for Children II) subtests,
~Social Relativeness, using Social Relativeness Scale parental questionnaire,
~Parental stress using PSI questionnaire"
15852672|NCT04021472|Behavioral|Text message|Two months of daily text messages to support meeting a health goal
15852673|NCT04021459|Procedure|blood samples|"3 samples: One before surgery on the arm vein (peripheral)
~Two during the surgery, on two different venipuncture site :
~One on the arm vein (peripheral)
~One on ovarian vein (close to the tumor) All samples will be tested by the CellSearch method."
15852674|NCT04021446|Other|Exercise|personalized exercise prescription
15852675|NCT04021433|Drug|Ketamine|Repeated doses of IM/SC ketamine up to 3 times a week
15852676|NCT04021420|Device|SONOCLOUD|"The SonoCloud System is an active implantable medical. The SonoCloud is indicated to locally and transiently increase the permeability of the blood brain barrier to facilitate the passage of substances into the cerebral parenchyma.
~The SonoCloud System consists of :
~an implantable ultrasound transducer,
~a needle connection device,
~an external radiofrequency generator, and
~an ultrasound resonator. The SonoCloud® is designed to be fixed to the skull. The device is placed in a burr hole or in place of a bone flap and ultrasound energy is delivered directly to the brain tissue, without traversing the skull bone. The device is activated by connecting the implant to the external generator system using the transdermal needle. Once connected to the external generator, the implant delivers low-intensity pulsed UltraSound (US) for duration of 120-270 seconds. A total of 3 US dose levels will be evaluated (0.78, 0.9 and 1.03 MPa)."
15852677|NCT04021420|Drug|Nivolumab Injection|Nivolumab (flat dose: 240mg, 30 minutes infusion)
15852678|NCT04021407|Device|LMA group|patients were ventilated with LMA
15852679|NCT04021407|Device|AirQ group|patients were ventilated with AirQ airway
15852680|NCT04021394|Diagnostic Test|CellSearch CTC platform|epithelial-based marker approach for immunomagnetic enrichment, isolation, and quantitative immunofluorescence of CTCs
15852681|NCT04021394|Diagnostic Test|Parsortix CTC platform|EMT-independent platform
15852684|NCT04021368|Drug|RVU120(SEL120)|RVU120(SEL120) will be administered as a single oral dose every other day (q.o.d.) for a total of 7 doses i.e. on Days 1, 3, 5, 7, 9, 11 and 13, in a 3-week treatment cycle.
15852685|NCT04021355|Other|Oral sodium supplementation|Participants will receive dietary sodium supplementation in the form of tablets to be taken either with breakfast or dinner.
15852686|NCT04021342|Dietary Supplement|Montmorency tart cherry concentrate|Based on previous analysis done by our laboratory each 60 ml of Montmorency tart cherry concentrate contains approximately 73.5 mg of anthocyanins (cyanidin-3-glucoside equivalents) and 178.8 mg of total phenolics (mean gallic acid equivalents)
15852687|NCT04021342|Dietary Supplement|Placebo|Placebo beverage matched for calorie content and visual properties of the cherry concentrate
15852688|NCT04021329|Behavioral|CBT Therapy|information added previously
15852689|NCT04021316|Other|dCELL® Human Dermis (decellularised dermal skin allograft - DCD)|DCD is produced from split thickness skin grafts (which comprise the epidermis and upper part of the dermis), and is retrieved from deceased tissue donors. All epidermal and cellular components from the dermis are removed in a patented sequential decellularisation process. As a decellularised graft, dCELL® Human Dermis fully integrates into the wound bed after application, replacing lost dermal tissue. It provides a scaffold into which the recipient's cells can grow, becoming vascularised and supporting the generation of a new epidermis, ultimately regenerating into normal skin.
15852690|NCT04021316|Other|Compression bandaging therapy|Compression therapy will be according to local practice and may include multilayer elastic compression bandaging or stockings delivering 20 to 40mm/Hg pressure.
15852691|NCT04021303|Dietary Supplement|Experimental cereal|Cereal containing probiotics, prebiotic fiber and low carbohydrates
15852692|NCT04021303|Dietary Supplement|Conventional cereal|Gluten free conventional cereal (from 4 to 6 months old) and conventional cereal with gluten (from 7 to 12 months old)
15852693|NCT04021290|Drug|DTG/3TC FDC|DTG/3TC FDC will be available as white, oval, film-coated tablets at a unit dose strength of 50 mg/300 mg. Participants will take DTG/3TC once daily via oral route.
15852694|NCT04021290|Drug|CAR|Participants who are randomized to the CAR arm will continue to take the current treatment until Week 52. CAR will include 2 NTRIs plus either an INI, NNRTI, or boosted PI or atazanavir unboosted.
15852695|NCT04021277|Combination Product|PS101 and Ultra Sound for escalation|Part 1 - dose escalation: PS101 given 3 times in a day + 1 US insonation for PK assessment and then PS101 +US insonation given 3 times on each chemotherapy administration day over a period of 8 weeks
15852696|NCT04021277|Combination Product|PS101 and Ultra Sound for expansion|Part 2: PS101 and US insonation given 3 times on each chemotherapy administration day over a period of 8 weeks
15852697|NCT04021264|Drug|Ropivacaine-Sufentanil|Local anesthetic injection
15852698|NCT04021264|Drug|Dextrose 5|Sham injection
15852699|NCT04021251|Device|P0.2|Investigational Medical Device collecting spectral raman data from tissue.
15852700|NCT04021238|Drug|Perflutren lipid microsphere|Baseline B-mode US will be performed to confirm the lesions being imaged (unless it is a subject with no lesions, then a basic B-mode US will be performed. Perflutren is a diagnostic drug that is intended to be used for contrast enhancement. The vial contains a clear, colorless, sterile, non-pyrogenic, hypertonic solution which is activated by mechanical agitation with Vialmix®.It will be dispensed in inactivated form to a study team member. The contrast agent will be activated just prior to administration (ideally to be used within 5 minutes of activation). Contrast agent Definity (or Lumason) will be activated according to package insert instructions, including use of VialMix®, the device used to activate Definity. Administration will occur IV in coordination with sonography staff trained specifically in contrast ultrasound imaging.The total imaging time is anticipated to be less than 30 minutes.
15852701|NCT04021238|Drug|Sulfur hexafluoride lipid microspheres|Baseline B-mode US will be performed to confirm the lesions being imaged (unless it is a subject with no lesions, then a basic B-mode US will be performed. Lumason will be used as a secondary contrast agent only if Definity(perflutren) is unavailable.This drug will be administered using the dosing range and administration type within the Lumason prescribing information. The contrast agent will be activated just prior to administration (ideally to be used within 5 minutes of activation). Contrast agent Definity (or Lumason) will be activated according to package insert instructions, including use of VialMix®, the device used to activate Definity. Administration will occur IV in coordination with sonography staff trained specifically in contrast ultrasound imaging.The total imaging time is anticipated to be less than 30 minutes.
15852702|NCT04021225|Device|Ectoin® Allergy Eye Drops 2%|A one-time application of 1-2 drops in the more affected eye will be investigated.
15852703|NCT04021225|Device|Ectoin® Eye Spray Colloidal|A one-time application of 1-2 drops in the more affected eye will be investigated.
15852704|NCT04021225|Device|Tears Again® eye spray|A one-time application of 1-2 drops in the more affected eye will be investigated.
15852705|NCT04021199|Genetic|Mody test|"Subjects will be screened using a MODY gene-sequencing test, which includes GCK, HNF1A, HNF4A, HNF1B, KCNJ11, ABCC8, and INS gene sequencing.
~More comprehensive genetic tests will be conducted in patients without anomalies found after the MODY gene-sequencing test."
15852706|NCT04021186|Other|Prevention of hyperglycemia|Bigger focus on postoperative blood-glucose levels in order to reduce incidents of hyperglycemia and other surgical complications.
15852707|NCT04021173|Drug|Anfibatide|5 IU/60kg intravenous infusion follow by 0.002 IU/kg/h continuous intravenous infusion
15852708|NCT04021173|Drug|Placebos|5 IU/60kg intravenous infusion follow by 0.002 IU/kg/h continuous intravenous infusion
15852709|NCT04021160|Device|High frequency repetitive transcranial magnetic stimulation (rTMS)|10hz, 20 seconds intertrain interval, 40 pulses per train with a total of 1000 pulse per session given at 100% of motor threshold. A total of 16 sessions will be given to each patient.
15852710|NCT04021160|Device|Sham stimulation|A sham coil will be used that is shielded so that it produces sounds and sensations similar to the active coil but does not produce therapeutic effects. 10hz, 20 seconds intertrain interval, 40 pulses per train with a total of 1000 pulse per session given at 100% of motor threshold. A total of 16 sessions will be given to each patient.
15852711|NCT04021147|Behavioral|Exercise plus action observation|Orofacial exercise plus action observation (video) of the same exercise
15852712|NCT04021147|Behavioral|Exercise plus motor imagery|Orofacial exercise plus motor imagery of the same exercise
15852713|NCT04021147|Behavioral|Exercise plus visual mirror feedback|Exercise plus visual mirror feedback
15852714|NCT04021147|Behavioral|Exercise|Orofacial exercises
15852715|NCT04021121|Drug|LZD|LZD 1200 mg daily
15852716|NCT04021121|Drug|High dose RIF|RIF 35 mg/kg/day
15852717|NCT04021121|Drug|Standard dose RIF|RIF 10 mg/kg/day
15852718|NCT04021108|Drug|Nivolumab 240 MG|Nivolumab (OpdivoTM) is a potent and highly selective humanized monoclonal antibody (mAB) designed to block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. Cancer cells are able to send a signal to the PD-1 via the PD-L1 molecule, tricking the T-cell into recognizing the cancer cell as normal. Nivolumab is designed to disrupt that signal and expose the cancer cell to the immune system. Nivolumab is given intravenously over a 60-minute period, usually every two weeks.
15852719|NCT04021095|Device|Head protection prototype device|The proposed experimental HPPD uses biocompatible material using FDMÔNylon which has high fatigue resistance, chemical resistance with impact resistance and toughness which is free of powders. It is HSA unclassified as yet and the FDMONylon is not FDA approved yet.
15852720|NCT04021082|Drug|Cerdulatinib|Small molecule SYK/JAK kinase inhibitor in development for treatment of hematological malignancies
15852721|NCT04021069|Diagnostic Test|Radiomic, pathomic, and clinical markers|This is a non-interventional study.
15852722|NCT04021056|Other|No intervention|
15852723|NCT04021043|Drug|Anti-GITR Agonistic Monoclonal Antibody BMS-986156|Given IV
15852724|NCT04021043|Biological|Ipilimumab|Given IV
15852725|NCT04021043|Biological|Nivolumab|Given IV
15852726|NCT04021043|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15852727|NCT04021030|Behavioral|Cognitive Behavioral Therapy (CBT)|The therapeutic intervention consists of 8, one-hour individual therapy sessions delivered over the course of 2 to 4 weeks with a trained CBT therapist. These sessions are designed to provide beneficial coping strategies that are helpful in dealing with both chronic pain and substance use.
15852797|NCT04020471|Other|Pain Scale/Medication Log|Daily recording of pain level after surgery and recording of medication taken for pain relief.
15852728|NCT04021017|Drug|Estradiol Hemihydrate Transdermal System|Participants who have had their first period or have a bone age greater than or equal to 14 years will receive PrClimara® 25 (estradiol hemihydrate transdermal system - 25 mcg/day) as a weekly patch, for 24 months. Participants who have not yet had their first period and have a bone age below 14 years will receive an increasing dose of estrogen. These participants will be initiated on graduated dose of transdermal 17-β estradiol patches: 3.1 mcg/day (1/8 patch) for first six-months, 6.2 mcg/day (1/4 patch) for second six-months, 12.5 mcg/day (1/2 patch) for third six-months and 25 mcg/day (full patch) for final six-months.
15852729|NCT04021004|Other|Survey Questionnaire|Survey Questionnaire
15852730|NCT04020991|Diagnostic Test|Sleep Study|Participants who noted to have Oxygen Desaturation Index more than 10 (moderate to severe OSA) will be referred to do formal sleep study and referral to Sleep Medicine Clinic
15852731|NCT04020978|Diagnostic Test|Parametric PET/CT|Each patient will undergo a dynamic F18-FDG PET/CT scan at baseline and 2-week post therapy.
15852732|NCT04020965|Behavioral|Water Treatment|"Hardware: Chlorine dispensers provided for free at communal water sources, available to households in intervention arm who were and who were not enrolled in the WASH Benefits Kenya study.
~Promotion: Local promoters visited compounds enrolled in the WASH Benefits Kenya study at least monthly during the first year and bi-monthly during the second (and last) year to deliver behavior change messages that focused on the treatment of drinking water for all children living in the household. Compounds in intervention villages that were not enrolled in the WASH Benefits Kenya study did not receive such visits. After the completion of the WASH Benefits Kenya study, the NGO Evidence Action conducted educational campaigns to promote the use of dispensers."
15852733|NCT04020965|Behavioral|Sanitation|"Only households enrolled in the original WASH Benefits study and assigned to the combined WASH and combined WASH + nutrition arms received this intervention.
~Hardware: Free child potties, sani-scoop hoes to remove feces from household environments, and new or upgraded pit latrine for each household enrolled in the WASH Benefits Kenya study. Upgrades included structural improvements, plastic slabs, and superstructure improvements. Households in intervention villages not enrolled in the original trial did not receive any hardware.
~Promotion: Local promoters visited compounds enrolled in the WASH Benefits Kenya study at least monthly during the first year and bi-monthly during the second (and last) year to deliver behavior change messages that focused on handwashing with soap at critical times around food preparation, defecation, and contact with feces. Compounds in intervention villages that were not enrolled in the original trial did not receive such visits."
15852734|NCT04020965|Behavioral|Handwashing|"Only households enrolled in the original WASH Benefits study and assigned to the combined WASH and combined WASH + nutrition arms received this intervention.
~Hardware: Handwashing dual tippy tap stations, including jugs for clean and for soapy water, for each compound. Handwashing stations were stocked with soap for the duration of the WASH Benefits Kenya study. Compounds in intervention villages who were not enrolled in the WASH Benefits Kenya study did not receive any hardware.
~Promotion: Local promoters visited compounds enrolled in the WASH Benefits Kenya study at least monthly during the first year and bi-monthly during the second (and last) year to deliver behavior change messages that focused on the use of latrines for defecation and the removal of human and animal feces from the compound. Compounds in intervention villages that were not enrolled in the WASH Benefits Kenya study did not receive such visits."
15852735|NCT04020965|Dietary Supplement|Nutrition|"Supplement: Lipid-based Nutrient Supplement (LNS) twice daily from ages 6 to 24 months, among children enrolled in the WASH Benefits Kenya study and for the duration of that study. Children in intervention villages who were not enrolled in the WASH Benefits Kenya study did not receive any supplements.
~Promotion: Local promoters visited compounds enrolled in the WASH Benefits Kenya study at least monthly during the first year and bi-monthly during the second (and last) year to deliver the following behavior change messages: (1) practice exclusive breastfeeding from birth to 6 months of age; (2) continue breast feeding with the introduction of LNS; (3) provide your child micronutrient-rich foods and vitamin A rich fruits and vegetables; and (4) feed your child at least 2-3 times per day when 6-8 months old and 3-4 times per day when 9-24 months old. Compounds in intervention villages that were not enrolled in the WASH Benefits Kenya study did not receive such visits."
15852736|NCT04020952|Other|"st.st 0.019×0.025 wire"|rectangular stainless steel wire that will be used during canine retraction after first premolars extraction
15852737|NCT04020952|Other|"st.st 0.016×0.022 wire"|rectangular stainless steel wire that will be used during canine retraction after first premolars extraction
15852738|NCT04020952|Other|"st.st 0.017×0.025 wire"|rectangular stainless steel wire that will be used during canine retraction after first premolars extraction
15852739|NCT04020939|Device|SPY imaging|Use of the SPY Pinpoint imaging device to evaluate intraoperative intestinal perfusion in children.
15852740|NCT04020939|Drug|Indocyanine Green|Intravenous injection of indocyanine green to evaluate the intestinal perfusion.
15852741|NCT04020913|Drug|Somatropin injection|"Boys with short stature will be studied for measures of:
~skeletal muscle strength, power, and endurance
~muscle agility
~lean body mass accrual
~bone mineral density and resting energy expenditure before and after 6 months and 12 months of GH administration"
15852742|NCT04020900|Other|Respiratory management|Data on respiratory management were collected at different time: data regarding the induction period, ventilatory parameters set and measured during a stable period, ventilatory change made during anaesthesia, use of recruitment manoeuvres, data regarding weaning and extubation
15852743|NCT04020887|Device|Alertwatch - Interaction|Decision-support software, customized for the PACU environment, Interaction between the telemedicine center and the PACU
15852744|NCT04020874|Behavioral|HuTT-2x|tackling and blocking training twice/week
15852745|NCT04020874|Behavioral|HuTT-4x|tackling and blocking training four times/week
15852746|NCT04020861|Device|Active PBM|To active photobiomodulation therapy (PBMT) the patient will be oriented to lie preferably in prone. The treatment area will be defined according to painful area. In the active group will be used the followings parameters: low-level laser therapy, 808 nm, 4 infrared diodes, 180 mW, 9 J. In the placebo PBMT will be performed a simulation of laser application. The cluster probe will be positioned on painful area during the same time of active PBMT, the equipment will be turned on and set, however the trigger will be not actived and no beam will be applied.
15852823|NCT04020211|Device|Senza HF10 Therapy|Senza 10kHz Spinal Cord Stimulation
15852853|NCT04019938|Radiation|Dual-energy X-ray absorptiometry|Cystatin C is measured as a part of routine investigation at the time of admission.
15852747|NCT04020861|Device|Active TENS|To active transcutaneous electrical nerve stimulation (TENS) the patient will be oriented to lie preferably in prone. Two or four electrodes standard square self-adhesive electrodes (5 × 5 cm2) will be positioned according to the painful area related by patient. It will be used the following parameters: frequency of 100 Hz, pulse duration of 125 µs (positive phase), 30 minutes of current stimulation and the pulse amplitude will be increased until the patient reports a strong but comfortable paresthesia (including motor level stimulation but no painful TENS). The amplitude will be adjusted (if necessary) each 5 minutes to keep a strong but comfortable paresthesia.
15852748|NCT04020861|Device|Placebo PBM|In the placebo PBMT will be performed a simulation of laser application. The cluster probe will be positioned on painful area during the same time of active PBMT, the equipment will be turned on and set, however the trigger will be not actived and no beam will be applied.
15852749|NCT04020861|Device|Placebo TENS|To placebo transcutaneous electrical nerve stimulation (TENS) Two or four electrodes standard square self-adhesive electrodes (5 × 5 cm2) will be positioned according to the painful area related by patient. This device was customized to deliver a current for 30 seconds (both channels) and then ramp off over the next 15 seconds so that it will be active for a total of 45 seconds. This will permit the patient to fell the TENS sensation while applying the settings.
15852750|NCT04020848|Other|Review of past medical history, clinical exam, and electroencephalogram, polysomnography and urine samples of melatonin and pupillometry.|Review of past medical history; review of paroxysmal events; identification of presence of seizures & epilepsy & epilepsy classification; characterization of the non-paroxysmal features; degree of paroxysmal, non-paroxysmal disability indices; Vineland II adaptive behavior scales scoring; behavioral evaluation; presence of a genetic mutation; pharmacological treatments already used; AHC paroxysmal events assessement during the time of study; patient calendar for the follow up of events, for the follow up of epileptic seizures; whether, or not, there was occurrence of a serious or potentially life-threatening event (status epilepticus, apnea requiring intervention, or death) during time of study; growth and somatic complaints; further information concerning family history & comorbidities; past instrumental & biochemical investigations (ECG, cardiac ultrasound results if done as part of patient's follow-up); electroencephalogram; polysomnography; urine samples of melatonin ; pupillometry
15852751|NCT04020848|Other|The patients' parents have to complete the VINELAND II adaptive behavior scales scoring, The Sleep Disturbance Scale for Children (SDSC) and Horne & Ostberg Circadian Typology Questionnaire|Sleep Disturbance Scale for Children ; Horne & Ostberg Circadian Typology Questionnaire
15852752|NCT04020822|Device|Guardian Sensor (3)|Guardian Sensor (3) connected to Guardian Link (3) Transmitter and/or Guardian Connect Transmitter.
15852753|NCT04020809|Drug|Atezolizumab|Anti-PD-L1 monoclonal antibody
15852754|NCT04020796|Dietary Supplement|Beetroot juice|Thirty-seven hypertension, with age 40-70 years were randomized to receive a 500ml volume of beetroot juice contains 11.5 mmol of inorganic nitrate or mineral water in a single moment.
15852755|NCT04020783|Other|NO Intervention|NO Intervention
15852756|NCT04020770|Other|Vibrating ball|Parameters: 5 30-sec bouts of 68Hz vibration followed by a 1-minute rest.
15852757|NCT04020757|Device|variation in dialysis bicarbonate|35 mEq/L dialysate bicarbonate for one week, followed by 30 mEq/L for one week, followed by 35mEq/L for one week with nutritional supplement during dialysis
15852758|NCT04020757|Dietary Supplement|Zone Perfect bar|16g protein supplement given during first 30 mins of dialysis on last testing day
15852759|NCT04020744|Other|real-time fMRI based neurofeedback from the hippocampus|During real-time fMRI neurofeedback, participants are trained to 'control' hippocampal activity. The training is accomplished by continuously measuring brain activity, analysing it in real-time, and then providing feedback about the current (and the targeted) brain activity to the participant.
15852760|NCT04020744|Other|real-time fMRI based neurofeedback from another brain area|During real-time fMRI neurofeedback, participants are trained to 'control' hippocampal activity. The training is accomplished by continuously measuring brain activity, analysing it in real-time, and then providing feedback about the current (and the targeted) brain activity to the participant.
15852761|NCT04020731|Behavioral|Hypnosis|several blocks of hypnosis including entry into a hypnotic state (= induction), the hypnotic trance and the exit from hypnosis (= reassociation).
15852762|NCT04020718|Behavioral|Brief telephone advice plus tailored text messages|All patients are offered brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training and a text message program tailored to readiness to quit and quit date. Content is personalized with user's name and Massachusetts General Hospital resources.
15852763|NCT04020718|Drug|Mailed nicotine replacement therapy|Patients who report continued smoking at Early or Late assessment (depending on random assignment) will be offered a 4 week supply of patches and/or lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette).
15852764|NCT04020718|Behavioral|Proactive telephone coaching|Patients who report continued smoking at Early (4-week) or Late (8-week) assessment of response will be randomized to receive proactive telephone coaching or not. Proactive coaching will consist of an attempt to reach the patient by telephone in order to review quit activities, provide information about locally available pharmacologic and behavioral treatment options and information sharing with patient's primary care provider. The coach is trained in core Tobacco Treatment Specialist activities.
15852765|NCT04020705|Device|Citicoline eye drops (OMK1)|(OMK1) will be prescribed in the dosage of 1 drop 3 times a day
15852766|NCT04020705|Other|Placebo Comparator: hypromellose based ocular lubricant|will be prescribed in the dosage of 1 drop 3 times a day
15852767|NCT04020692|Behavioral|EOPC Intervention|"The issue of drug continuity after hospital discharge has become a major issue in recent years. When patients return home, the drugs taken do not correspond to the treatments prescribed at the end of the hospitalization. This is due to appropriate or inappropriate initiatives of the patients (or their relatives) and/or the physicians accompanying them. Prescribed medications, on the other hand, are almost always dispensed by community pharmacists.
~The scope chosen in this project is that the intervention of an operational clinical pharmacy team (EOPC), targeting both patient and health care professionals (inpatient and outpatient), will maintain, in outpatient care, the drugs treatments that have been optimized during hospitalization."
15852850|NCT04019951|Dietary Supplement|Ca-propionate 1 g|1 g of Ca-propionate will be mixed in 203 mL of a standardized liquid breakfast
15852768|NCT04020679|Behavioral|Goals of Care Initiative|Can-GUIDE will provide videos on a number of SDM topics including interviews with patients and clinicians discussing patient involvement in SDM and how goal conversations can inform the decision making process. Furthermore, there will be instructional videos on how to complete the Goal conversations sheet. Accompanying the videos will be interactive elements which will help users consider the types of questions that they wish to ask their clinical teams. The goal conversation sheet allows patients to list their goals and priorities that they wish to bring up in the consultation with their clinical teams. The Goals of Care (GOC) tool is a communication aid for clinicians to summarise goals of care discussions such as those facilitated by the goals conversation sheet. The completed tool will then be logged onto the Electronic Patient Record (EPR) and is then disseminated to other HCPs involved in the patients care.
15852769|NCT04020666|Drug|Urinary Kallidinogenase|
15852770|NCT04020653|Drug|5-aminolevulinic acid hydrochloride (5-ALA HCl) 600 mg QD|5-ALA HCl 150 mg capsules will be given to the patients as 600 mg QD
15852771|NCT04020653|Drug|Sodium ferrous citrate (SFC) 472 mg QD|SFC 118 mg capsules will be given to the patients as 472 mg QD
15852772|NCT04020653|Drug|Artemisinin-based combination (ACT)|Tablets of ACT will be administered following Dosage and Administration in the package insert of ACT. ACT will be supplied as a combination tablet.
15852773|NCT04020653|Drug|Placebo|Matching placebo capsules to 5-ALA HCl and SFC will be administered to the patients
15852774|NCT04020653|Drug|5-aminolevulinic acid hydrochloride (5-ALA HCl) 300 mg BID|5-ALA HCl 150 mg capsules will be given to the patients as 300 mg BID
15852775|NCT04020653|Drug|Sodium ferrous citrate (SFC) 236 mg BID|SFC 118 mg capsules will be given to the patients as 236 mg BID
15852776|NCT04020640|Other|no intervention|Measure human intake using stable isotope technique
15852777|NCT04020627|Other|BiPAP Group|"BIPAP
~- 1hr after every 6hrs for 3 days/week Conventional physiotherapy Treatment (Percussion, vibration, shaking) Modified postural drainage Incentive spirometer Blow bottle/Tissue blowing/Positive Expiratory Pressure(PEP) device"
15852778|NCT04020627|Other|CPAP Group|"CPAP
~- 1hr after every 6hrs for 3 days/week Conventional physiotherapy Treatment (Percussion, vibration, shaking) Modified postural drainage Incentive spirometer Blow bottle/Tissue blowing/PEP device"
15852779|NCT04020614|Other|Survey|A survey with 13 questions will be applied to the patients
15852780|NCT04020601|Drug|Ropivacaine|Local anesthetic injection
15852781|NCT04020601|Drug|Dextrose|Sham injection
15852782|NCT04020588|Drug|Celecoxib 200mg|Will be administered for 6 weeks
15852783|NCT04020588|Drug|Placebo oral capsule|Will be administered for 6 weeks
15852784|NCT04020588|Drug|Minocycline 100mg|Will be administered for 6 weeks
15852785|NCT04020575|Biological|huMNC2-CAR44 CAR T cells|huMNC2-CAR44 T cells are an autologous T cell product transduced with a proprietary lentiviral vector backbone coding for humanized MNC2-scFv (the targeting head).
15852786|NCT04020575|Biological|huMNC2-CAR44 CAR T cells @ RP2D|huMNC2-CAR44 T cells are an autologous T cell product transduced with a proprietary lentiviral vector backbone coding for humanized MNC2-scFv (the targeting head) @ RP2D
15852787|NCT04020562|Other|Mild Resistive Expiratory Technique|"Mild Resistive Expiratory Technique (EMST150- five-week training protocol):
~The EMST requires the participant to forcibly blow into the device for 5 seconds with sufficient pressure to open the one-way valve. Each blow is one repetition. The device will be set at a resistance of 30 cmH2O. Participants will be instructed to complete five sets of five repetitions (total of 25 times and approximately 20 minutes per day), any five days per week, for five weeks. Whole exercise will be done in sitting position. Rest between repetitions will be given according to comfort level of patient."
15852788|NCT04020562|Other|Conventional Training|"Breathing exercise: Deep breathing 10-15 repetitions twice a day. Assistive Coughing: 5-6 repetitions twice a day. ROM Exercises: Both active and passive limb ROM exercises 10-15 repetitions twice a day.
~Sustained stretching: Both upper and lower limbs, 10 repetitions, held for 5 seconds, twice a day.
~Splinting: According to patient's injury level Bracing: According to patient's injury level Functional Mobility: Mobilizing patient according to injury level Tilt table standing: 10-15 minutes once a day"
15852789|NCT04020549|Behavioral|Growth, Gratitude, & Positive Activities|Reading and writing activities based on growth (designed to instill the belief that people can change), gratitude (noticing and appreciating good things in life), and behavioral activation (identifying and scheduling positive activities).
15852790|NCT04020549|Behavioral|Study Skills Control|Reading and writing activities designed to teach evidence-based study strategies.
15852791|NCT04020536|Drug|Antibiotics|Local doctors prescribe available antibiotics to the patients according to the guideline and patients' condition
15852793|NCT04020510|Drug|onaBoNT-A|Intradetrusor onabotulinumtoxinA in either the standard number of injections or a reduced number of injections
15852794|NCT04020497|Behavioral|Ensemble programme|Ensemble is a individualized programme to address informal caregiver's specific unmet needs, emotions and social resources, in order to offer a targeted support in five sessions.
15852795|NCT04020497|Other|SAU|"Informal caregivers have often to manage the situation in usual different ways. Support as usual (SAU) alone consists of an informal support by patient's clinical team. Specific psychoeducational programs depending on patient's illnes (like Profamille for schizophrenia) or peer-support depending to the voluntary work of families' associations. Some general professional services focused on informal caregivers or relatives in order to inform and orient them if they are avaible in the study area. No attempts have been made to standardize this treatement as SAU depend to informal caregiver's need and knowledge of the health system, also her/his capacity or possibility to be in contact with patient's clinical team."
15852796|NCT04020484|Behavioral|Making Mindfulness Matter© (M3)|Making Mindfulness Matter© (M3) is an interactive online parent and child program that incorporates mindful awareness, social-emotional learning skills, neuroscience, and positive psychology. This program was modelled after the school-based MindUP™ program for use in the community and augmented to integrate a parent component. M3E is a facilitator-led program that integrates attitudes, skills, and behaviours related to mindfulness and social-emotional learning (SEL). During the 8-week concurrent parent and child manualized program, parents learn the same core principles as children: how our brains work, stress and the brain, mindful breathing, mindful sensing, mindful movement, perspective taking, optimism, and gratitude/acts of kindness.
15852798|NCT04020458|Procedure|dental intervention|"Dental intervention plan for Group 1 and 3 subjects with periodontitis only, i) Full mouth intraoral X-rays (FMX)
~ii. Full periodontal exam, diagnosis, Oral hygiene instructions (OHI)
~iii. RX: 7 days of p.o. metronidazole (250mg)/amoxicillin (500mg) T.I.D., combined with local chlorhexidine rinses (not for subjects with Kidney transplant).
~iv. Single visit intensive scaling and root planning (SRP) (full mouth)
~v. Re-evaluation after 4-6 weeks (referral for definitive treatment)
~vi. Extraction of teeth deemed hopeless based on periodontal, endodontic or restorative considerations
~vii. Caries control, sedative dressing (palliative), referral to endodontic dentist for root canal treatment (RCT)"
15852799|NCT04020445|Other|de-escalation of complex insulin regimens|complex insulin regimens are switched to fix ratio combinations consisting of of a basal insulin and a GLP-1 (glucagon-like peptide-1) receptor agonist
15852800|NCT04020432|Behavioral|questionary|"A quantitative questionnaire has been created under primary and secondary assumptions. Questionnaires are going to be distributed to women who are agree to participate to this study. The questionnaires are going to be delivered by the investigators.
~Women can answer the questionnaire in the waiting room of consultation's services. The questionnaire will be anonymous and the return of questionnaires will be made personally."
15852801|NCT04020419|Drug|PediaBerry|PediaBerry or placebo will be mixed with a cream vehicle for topical administration or with water for oral administration
15852802|NCT04020406|Biological|Antibacterial Activity|Antibacterial Activity of Urea Solution against Ocular Bacterial Isolates
15852803|NCT04020393|Procedure|SPGB|SPGB was performed by the operating surgeon using a transnasal endoscopic approach before septorhinoplasty in the Block group. The prepared solution (4 cc % 4 lidocaine and 1 cc 8 mg dexamethasone) was delivered by a Mucosal Atomization device (LMA MADgic™ Laryngo-Tracheal Mucosal Atomization Device, US). 2,5 cc of the prepared solution was given to each side of the nose.
15852804|NCT04020380|Drug|Azithromycin 250Mg Capsule|250 mg OD
15852805|NCT04020367|Procedure|biopsy of mucosa's olfactory|intervention under general or local anesthesia
15852806|NCT04020354|Behavioral|HABIT-ILE|Early Hand and arm bimanual intensive therapy including lower extremities
15852807|NCT04020354|Behavioral|Usual Care|Usual customary care
15852808|NCT04020341|Drug|Gepotidacin|Gepotidacin will be available as tablets containing 750 mg gepotidacin. Each dose should be taken with water after consumption of food.
15852809|NCT04020341|Drug|Placebo matching nitrofurantoin|Placebo matching nitrofurantoin will be available as over-encapsulated unit-dose capsules. Each dose should be taken with water after consumption of food.
15852810|NCT04020341|Drug|Nitrofurantoin|Nitrofurantoin will be available as over-encapsulated capsules containing 25 mg nitrofurantoin macrocrystals and 75 mg nitrofurantoin. Each dose should be taken with water after consumption of food.
15852811|NCT04020341|Drug|Placebo matching gepotidacin|Placebo matching gepotidacin will be available as unit-dose gepotidacin placebo-to-match tablet. Each dose should be taken with water after consumption of food.
15852812|NCT04020328|Drug|Leflunomide 20 mg+prednisone 0.5mg/kg/d|Leflunomide plus low dose glucocorticoids to have the immunosuppressive therapy to those progressive IgA nephropathy with eGFR<50ml/min
15852813|NCT04020315|Procedure|Non-surgically performed scaling and root planing|Non-surgically performed scaling and root planing
15852814|NCT04020302|Behavioral|Self-monitoring shopping intervention|Intervention will occur once per week for a duration of 8 weeks. The intervention format will alternate between individual and group sessions, so that the first week of intervention will be provided in a group format, the second week will be provided in an individual format, and so forth. Sessions will be 90 minutes in duration. Data will be collected during individual sessions, which will occur every other week. During individual sessions, each participant will meet at the facility for the first 15 minutes, will travel to a local grocery store for 45 minutes, and then reconvene at the facility for the final 30 minutes. Group sessions will follow the same structure; however, all ten participants will be present. Each of the 8 sessions will consist of the following: awareness training; facilitation of strategy generation; facilitation of error detection; reinforcement of self-monitoring techniques; and opportunity for participants to practice self-monitoring techniques.
15852815|NCT04020289|Behavioral|"Psychoeducational Program BalancingMySwing"|"Patients in the intervention arm will receive a nurse-lid 8-session psychoeducational 'BalancingMySwing group psychotherapy"
15852817|NCT04020263|Drug|Levosimendan 2.5 MG/ML Injectable Solution|Levosimendan will be diluted with Glucose G5%. The reconstitution of levosimendan will be performed, as close as possible to the start of the infusion. A continuous infusion of levosimendan will be administered over 24 h without bolus, started at a rate of 0.1 μg per kilogram of body weight per minute and, in both the persistence of hypoperfusion signs and in the absence of rate-limiting side effects, will be increased after 2 to 4 hours to a maximum of 0.2 μg per kilogram per minute for a further 20 to 22 hours.
15852818|NCT04020263|Drug|Placebo|Placebo will be diluted with Glucose G5%. The reconstitution of Placebo will be performed, as close as possible to the start of the infusion. A continuous infusion of Placebo will be administered over 24 h without bolus, started at a rate of 0.1 μg per kilogram of body weight per minute and, in both the persistence of hypoperfusion signs and in the absence of rate-limiting side effects, will be increased after 2 to 4 hours to a maximum of 0.2 μg per kilogram per minute for a further 20 to 22 hours.
15852819|NCT04020250|Device|Echocardiography|"Echocardiographic parameters:
~Tricuspid annulus plane systolic excursion (TAPSE) Tricuspid regurgitation peak gradient (TRPG)"
15852820|NCT04020237|Behavioral|Education about particulate matter practice score|"For the intervention group, specific guidance is given to the patient who might be exposure in environment with higher particulate matter concentration.
~1) Start air purifier
~2) Do not go out and make it to the minimum when absolutely necessary
~3) It is recommended to wear a mask when going out.
~4) The investigators recommend a lot of water, fresh fruit and vegetables.
~5) Prepare an inhaler and use it when symptoms get worse."
15852821|NCT04020224|Device|Amustaline/GSH pathogen reduction technology|Whole blood treated with pathogen reduction technology
15852822|NCT04020224|Device|Standard of Care|Red Blood Cell Component or whole blood
15857400|NCT03983239|Drug|Fedratinib|Fedratinib
15852824|NCT04020198|Other|Biomarker assay|Biomarker assay will be used to quantify levels of misfolded alpha-synuclein aggregates in biofluid samples from patients with Parkinson's disease, multiple system atrophy, rapid eye movement sleep behavior disorder, normal pressure hydrocephalus and controls.
15852825|NCT04020185|Drug|IMSA101|IMSA101 administered by intra-tumoral (IT) injection on Day 1 of Weeks 1, 2, and 3 for Cycle 1 and on Day 1 of Weeks 1 and 3 for all subsequent cycles.
15852826|NCT04020185|Drug|Immune checkpoint inhibitor (ICI)|Administered according to product label
15852827|NCT04020185|Drug|Immuno-oncology (IO) therapy|Administered according to product label
15852828|NCT04020172|Drug|Dobutamine|intraoperative fluid administration will be guided by cardiac output monitoring
15852829|NCT04020159|Other|Patient Registry|No intervention/treatment
15852830|NCT04020146|Other|Gingival biopsies|Gingival biopsies were obtained from all participants and biopsy samples underwent histological tissue processing.
15852831|NCT04020133|Procedure|saphenous nerve block|"The skin is disinfected and the saphenous nerve is located via Ultrasound . the transducer is placed anteromedially, approximately at mid-thigh level a high-frequency linear probe 5Y12 MHz prepared in a sterile fashion (Phillips HD11) .
~The block needle (Stimuplex; Braun Medical, Bethlehem, Pa), is inserted in plane in a lateral-to-medial orientation and advanced toward the femoral artery .Once the needle tip is visualized anterior to the artery and after careful aspiration, 1-2 mL of local anesthetic is injected to confirm the proper injection site . When injection of local anesthetic does not appear to result in its spread around the femoral artery, additional needle repositions and injections may be necessary."
15852832|NCT04020133|Procedure|popliteal plexus block|After doing saphenous nerve block , we will move distally with the artery in the adductor canal until it moves away from the sartorius muscle to enter adductor hiatus . here , we will inject L.A above artery and so , popliteal plexus block will be accomplished
15852833|NCT04020133|Drug|Plain bupivacaine|15ml of plain bupivacaine 0.5% will be given in both blocks
15852834|NCT04020133|Drug|0.05 mg epinephrine|0.05 mg epinephrine will be added to bupivacaine in both blocks to prolong their duration
15852835|NCT04020120|Other|questionnaires|answer questionnaires
15852836|NCT04020107|Other|Compressive garment and Somatosensori Remediation|Each patient will benefit successively: from a classic care, over a period of 2 to 4 months, then will be treated with compressive or low compressive garments associated with specific proprioceptive physiotherapy program during the next 4 months. Finally, the 4 last months, patient will made adapted physical activity with both dance sessions strengthening the body diagram and stretching sessions
15852837|NCT04020094|Combination Product|MVA-BN-Brachyury|"Cycle= 21 days. Neoadjuvant Therapy: Treatment will be given for 2 neoadjuvant cycles. MVA-BN-Brachyury will be administered as intratumoral injection on Day 1 of each of 2 neoadjuvant cycles. PROSTVAC-V will be administered as a subq injection on Day 1 of Cycle 1 (the first neoadjuvant cycle) and PROSTVAC-F will be administered as a subq injection on Day 1 of Cycle 2 (the second neoadjuvant cycle). Atezolizumab will be given as an infusion on Day 1 of each 2 neoadjuvant cycles.
~MVA-BN-Brachyury will be injected intratumorally into the prostate. Injections will target PI-RADS 4 and 5 lesions.
~Surgery: Patients will undergo SOC radical prostatectomy Adjuvant Therapy: Systemic treatment with atezolizumab and PROSTVAC-F will be reinitiated between 3 to 8 weeks after surgery and will continue for an additional 6 cycles. PROSTVAC-F will be given as a subq injection on Day 1 of each cycle. Atezolizumab will be given as an infusion on Day 1 of each cycle."
15852838|NCT04020081|Other|Yoga breathing exercises and Meditation|"8 Breathing exercises.The first set of 6 exercises is of the Upper Lobe breathing (Upper and Middle Lobe of the Lungs) while 7th exercise is abdominal breathing,8th exercise is yogic breathing.
~6-steps Nirmal Dhyan (meditation).Step 1: Breath awareness,Step 2: Body awareness,Step 3: Thought awareness,Step 4: Refreshing awareness,Step 5: Gap awareness,Step 6: Expanding awareness."
15852839|NCT04020055|Drug|migalastat HCl 150 mg|migalastat HCl 150 mg capsule
15852840|NCT04020042|Other|Ultrasound image guidance|Epidural landmarks will be determined with using ultrasound image
15852841|NCT04020042|Other|Landmark palpation|Epidural landmarks will be determined with palpation
15852842|NCT04020029|Other|Mindset|Mindset Intervention will include watching three brief ~10-25 minute films
15852843|NCT04020029|Other|Reflection activities|Reflection activity include exercises to internalize the message
15852844|NCT04020016|Drug|Nalbuphine ER|Cohort 1: 6-8 subjects will receive 1 dose of 27mg and observed for 4 days. Cohort 2: 6-7 subjects will receive 1 dose of 54 mg and observed for 4 days. Cohort 3: 6-7 subjects will receive 1 dose of 108 mg and observed for 4 days. Cohort 4: 6-8 subjects will receive 1 dose of 162 mg and observed for 4 days. Cohort 5: 6-8 healthy subjects will receive dosing of NAL ER and observed for 4 days.
15852845|NCT04020016|Drug|Nalbuphine ER -|Cohort 6: • 6-8 subjects with mild hepatic impairment and 6-8 subjects with moderate hepatic impairment. Doses will be subsequently escalated for each subject starting at 27 mg on Day 1 to twice daily, 12 hours apart, 27 mg, 54 mg, 108 mg, and 162 mg over 13 days.
15852846|NCT04020003|Drug|Levosimendan|General treatment group: control the infection, remove or control the original disease, mechanical ventilation, small tidal volume, high PEEP mechanical ventilation strategy, strictly control the capacity, strengthen the airway management, timely nutrition support and intensive rehabilitation treatment. Levosimendan group: on the basis of routine group treatment, 12.5 mg of levosimendan 5% GS 50ml was given on the same day, and the micro-pump was continuously pumped for 24 hours. The initial dose was 0.5 ml/ h, and if the blood pressure was not significantly decreased, the blood pressure was gradually increased to 2.4 ml/ h at the maximum dose, until the pump was over. The above treatment is repeated every 7 days until the offline success or the patient leaves the ICU.
15852847|NCT04019990|Other|The effect of throwers ten exercise programme on wheelchair basketball and ambulant basketball players|Throwers Ten exercise programme is a programme designed to improve the power, strength and endurance of large muscle groups required for the throwing activity. It consists of exercises involving the movement of upper limb joints in full range of joint motion or at specified specific angles, with the help of a resistance band and weights specific to individual athletes. In the literature, no study has demonstrated the effectiveness of Throwers Ten exercise programme in wheelchair basketball and ambulant basketball players.
15852848|NCT04019977|Other|Nurse Home Visiting Program|Brief nurse home visiting program
15852849|NCT04019964|Drug|Nivolumab|Nivolumab 480mg intravenously every 4 weeks
15857401|NCT03983239|Drug|Rifampin|Rifampin
15852855|NCT04019912|Other|Gait Training plus music|GaitTrainer3 is a platform that integrates gait training via a treadmill and RAS. The device is indeed equipped with an instrumented deck that issues acoustic cues to determine the exact tempo and rhythm during gait training and visual real-time biofeedback to prompt patients to follow their gait pattern. In fact, the device provides online feedback, including step length, speed, and symmetry, to encourage patient progress and monitor patient performance. Patient footfalls were compared in real-time to the desired footfalls step by step and documented in a histogram.
15852856|NCT04019912|Other|Traditional Gait Training|The traditional training will be provided by a conventional treadmill.
15852857|NCT04019899|Dietary Supplement|control group|"2 g Myo-Inositol, 50 mg Alpha-Lactalbumin and 200 µg folic acid (1 sachet/day in the morning): from the first day of the menstrual cycle until 14 days after embryo transfer. If pregnancy occurs, until the 12th week of gestation.
~600 mg Myo-Inositol, 200 µg folic acid, 1 mg melatonin (1 soft capsule/day in the evening): from the first day of the menstrual cycle until hCG administration. If pregnancy occurs, until the 12th week of gestation."
15852858|NCT04019899|Dietary Supplement|study group|"2 g Myo-Inositol, 50 mg Alpha-Lactalbumin and 200 µg folic acid (1 sachet/day in the morning): from the first day of the menstrual cycle until 14 days after embryo transfer. If pregnancy occurs, until the 12th week of gestation.
~600 mg Myo-Inositol, 200 µg folic acid, 1 mg melatonin (1 soft capsule/day in the evening): from the first day of the menstrual cycle until hCG administration;
~600 mg Myo-Inositol, 200 µg folic acid, 1 mg melatonin, 50 µg vitamin D3 as cholecalciferol (1 soft capsule/day in the evening) substitutes the previous treatment at hCG administration and lasted until 14 days after embryo transfer. If pregnancy occurs, until the 12th week of gestation."
15852859|NCT04019886|Other|Neurophysiological Facilitation of Respiration|Six neuro-facilitation techniques will be given to experimental group. Each technique will be given for 5 seconds hold with 5 repetitions and two sets.
15852860|NCT04019873|Drug|Dolutegravir (DTG)|DTG is a 2nd generation integrase strand transfer inhibitor. Subjects receiving DTG as a part of 2DR treatment will be included in the study.
15852861|NCT04019873|Drug|Lamivudine (3TC)|3TC is a nucleoside reverse transcriptase inhibitor. Subjects receiving 3TC as a part of 2DR treatment will be included in the study.
15852862|NCT04019873|Drug|Rilpivirine (RPV)|RPV is a non-nucleoside reverse transcriptase inhibitor. Subjects receiving RPV as part of 2DR treatment will be included in the study.
15852863|NCT04019860|Behavioral|High Intensity Interval Training|Three weekly, supervised exercise sessions with high intensity. Each session will last for 30-45 minutes. Intervention period will be seven weeks.
15852864|NCT04019860|Behavioral|Time-Restricted Eating|Restricted daily window of caloric intake to maximum 10 hours. Intervention period will be seven weeks.
15852865|NCT04019847|Device|STAK Tool|Medical stretching device
15852866|NCT04019847|Other|Standard treatment|Physiotherapists tailor treatment of arthrofibrosis to meet their patients' individual needs. Treatment may comprise the following: education, advice and a range of stretching exercises/techniques to change the length and density of the adhesions and shortened tissue. These include active range of movement (AROM), passive range of movement (PROM), strengthening exercises, hands-on high intensity passive physiological stretches, joint mobilisations and a home exercise programme involving full weight bearing exercises with the aim of enabling the patient to regain AROM and function
15852867|NCT04019834|Drug|regional nerve block with local anesthesia of bupivacaine with steroid|Patient will receive titrated sedation with a combination of fentanyl and versed prior to the start of the block. An ultrasound will be used to identify the fascial planes for either pectoral, serratus, or erector spinae nerve blocks. A block needle will be passed into the fascial plane and injectate will be deposited. The injectate in the active arm will contain a combination of bupivacaine, epinephrine and dexamethasone.
15852868|NCT04019834|Other|Placebo regional nerveblock with normal saline|Patients who are randomized to placebo will undergo the same procedure with the exception of injection of 10cc of normal saline into the subcutaneous tissue .
15852869|NCT04019821|Drug|Insulin Glulisine|A type of bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial.
15852870|NCT04019821|Drug|Insulin Aspart|A type of bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial.
15852871|NCT04019821|Drug|Insulin Lispro|A type of bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial.
15852872|NCT04019795|Device|REVIAN 101|"The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites.
~REVIAN 101 delivers 625 nm and 660 nm wavelengths of red light."
15852873|NCT04019795|Device|REVIAN 102|"The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites.
~REVIAN 102 delivers 425 nm wavelength of blue light."
15852874|NCT04019795|Device|REVIAN 103|"The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites.
~REVIAN 103 delivers 425 nm wavelength of blue light and 625 nm and 660 nm wavelengths of red light."
15852875|NCT04019795|Device|REVIAN 100|"The REVIAN System includes a Cap configured for portable use with rechargeable battery and adapter with active LEDs using modulated light therapy (MLT trademark). Daily 10-minute treatments are done in the home over the course of 26 weeks. Intervention adherence will be assessed via firmware in the Cap and monitored by the clinical sites.
~REVIAN 100 contains LEDs that are not powered for light therapy"
15852876|NCT04019782|Drug|Collagen-PVP|Infiltrations of 1.5 ml collagen-polyvinyl pyrrolidone (collagen-PVP) plus 1 mL of 2% xylocaine without epinephrine, administered by intraarticular injections (three doses, one each 7 days)
15852877|NCT04019782|Device|Hylan G-F 20|Infiltrations of 2 mL 0.8% Hylan G-F 20 (16 mg) solution, administered by intraarticular injections (three doses, one each 7 days)
15852878|NCT04019769|Drug|L-glutamine|product will be obtained by Endari and administered by NIH pharmacy. Patient will take supplement as prescribed
15852879|NCT04019743|Drug|CKD-330 16/10mg Tab. 1T and D086 Tab. 1T|single oral administration under fasting condition
15852880|NCT04019743|Drug|CKD-333 16/10/40mg formulation 1 Tab. 1T|single oral administration under fasting condition
15852881|NCT04019743|Drug|CKD-333 16/10/40mg formulation 2 Tab. 1T|single oral administration under fasting condition
15852882|NCT04019730|Other|diet|low carbohydrate diet (< 10 EN% carbs) vs high carbohydrate diet (>50 EN% carbs)
15852883|NCT04019717|Drug|AT-527|Nucleotide prodrug inhibitor of HCV nonstructural protein 5B (NS5B) polymerase
15852884|NCT04019717|Drug|Daclatasvir|Inhibitor of HCV nonstructural protein 5A (NS5A)
15852885|NCT04019704|Drug|AXS-05|Oral AXS-05 tablets, taken daily for 6 weeks.
15852886|NCT04019704|Drug|Placebo|Placebo to match oral AXS-05 tablets, taken daily for 6 weeks.
15852887|NCT04019691|Device|Mix-and-Match|Phacoemulsification and implantation of Tecnis ZKB00 multifocal IOL with +2.75 D add power (Abbott Medical Optic Inc., Santa Ana, CA) in the dominant eye, and a Tecnis ZLB00 multifocal IOL with +3.25 D add power (Abbott Medical Optics Inc.) in the non-dominant eye.
15852888|NCT04019691|Device|EDOF|Phacoemulsification and implantation of Tecnis Symfony ZXR00 trifocal IOLs (Abbot Medical Optics Inc.) in both eyes.
15852889|NCT04019691|Device|Trifocal|Phacoemulsification and implantation of FineVision PodFT IOLs (PhysIOL SA) in both eyes.
15852890|NCT04019678|Procedure|Omission of Axillary dissection|In Group 1 and 2: Axillary dissection won't be performed
15852891|NCT04019665|Other|MMSE (mini mental state examination)|mini mental state examination takes place during the consultation. The consultation is a general or post-emergency geriatric consultation.
15852892|NCT04019665|Other|SAGE (Self-Administered Gerocognitive Exam)|SAGE test contains a series of questions that assess the cognitive functioning. Sage was developed by the Ohio State University Wexner Medical Center. it's an online, at-home, self-screening dementia tool that has been scientifically evaluated, and it's demonstrated good results in accurately identifying cognitive deficits.
15852893|NCT04019652|Drug|CS-3150|Single, oral administration; 10-mg or 40-mg dose
15852894|NCT04019652|Drug|Moxifloxacin|Single, oral administration; 400 mg-tablet
15852895|NCT04019652|Drug|Placebo matching moxifloxacin tablet|Placebo tablets matching moxifloxacin tablets
15852896|NCT04019652|Drug|Placebo matching CS-3150|Placebo tablets matching CS-3150 tablets
15852897|NCT04019639|Device|application of CG Paste+EasyFoam|Prior to application of CG paste, sharp debridement can be performed first in the operating room under local anesthesia or general anesthesia. After this, hemostasis is performed by an electrocoagulator and the medical device is applied to the affected area. During the procedure, remove the packaging material and remove the syringe to remove the protective cap in front of the syringe. Slowly push the syringe plunger and apply the contents to the area where you want to use. Depending on the location and size of the wound area, an injection cap can be used. Apply CG paste and apply Easyfoam to finish the dressing.
15852898|NCT04019639|Device|application of EasyFoam|Prior to applying EasyFoam, sharp debridement can be performed first in the operating room under local anesthesia or general anesthesia. Marginal resection is performed until the necrotic tissue is removed sufficiently and pin point bleeding is seen on the wound. After that, hemostasis is done with an electrocoagulator and EasyFoam is applied to the affected area.
15852899|NCT04019626|Other|Continue-smoking|Ad-libitum use of subjects' usual brand combustible cigarette
15852900|NCT04019626|Other|myblu Tobacco 2.5%|Ad-libitum use of myblu e-cigarette with Tobacco flavor 2.5% nicotine
15852901|NCT04019626|Other|myblu Tobacco 4.0%|Ad-libitum use of myblu e-cigarette with Tobacco flavor 4.0% nicotine
15852902|NCT04019626|Other|myblu Honeymoon 2.5%|Ad-libitum use of myblu e-cigarette with Honeymoon flavor 2.5% nicotine
15852903|NCT04019626|Other|myblu Honeymoon 4.0%|Ad-libitum use of myblu e-cigarette with Honeymoon flavor 4.0% nicotine
15852904|NCT04019626|Other|JUUL 5%|Ad-libitum use of JUUL 5% e-cigarette
15852905|NCT04019613|Diagnostic Test|Lung ultrasound|Lung ultrasound will be performed at baseline (resting), prior to exercise with passive leg elevation, after 1.5 minutes of 20 Watts exercise, during each subsequent stage, at peak workload and at 1 minute recovery. Pulmonary thermodilution will be performed at rest, peak stress and at 1 minute recovery.
15852906|NCT04019600|Other|Echocardiography|Demographic data and health risk factors will be collected on day of screening, together with the above tests. Right heart catheterization will be separately arranged in patients with a high echocardiographic probability of PAH. For those with a low-intermediate echocardiographic probability, screening will be repeated within 1 year to ensure true negativity of the original scan.
15852907|NCT04019587|Diagnostic Test|Fear of Falling Avoidance Behavior Questionnaire administration|The Questionnaire includes 14 items dealing with avoidance behavior. All items will be asked by face to face technique.
15852908|NCT04019574|Drug|CR845 0.5 mcg/kg IV|0.5 mcg/kg IV CR845
15852909|NCT04019574|Drug|CR845 3 mcg/kg IV|3 mcg/kg IV CR845
15852910|NCT04019574|Drug|Moxifloxacin 400 mg Oral Tablet|400 mg Oral Moxifloxacin
15852911|NCT04019574|Other|Placebo|IV Placebo as a bolus injection
15852912|NCT04019561|Drug|MEDI0382 high dose|MEDI0382 high dose administered subcutaneously
15852913|NCT04019561|Drug|Placebo for MEDI0382 high dose|Placebo for MEDI0382 high dose administered subcutaneously
15852914|NCT04019561|Drug|MEDI0382 low dose|MEDI0382 low dose administered subcutaneously
15852915|NCT04019561|Drug|Placebo for MEDI0382 low dose|Placebo for MEDI0382 low dose administered subcutaneously
15852916|NCT04019548|Device|Percutaneous Endoscopic Gastrotomy tube placement|placement of the PEG tube depends on arm
15852917|NCT04019548|Drug|Cisplatin injection|"Two therapeutic regimen allowed:
~Days 1 and 22 : cisplatin 100mg/m2 IV
~Days 1,8,15,22,29,36: weekly cisplatin 40 mg/m2 IV"
15852918|NCT04019548|Radiation|Radiotherapy|Simultaneous integrated boost (SIB) intensity modulated radiotherapy (IMRT). The median dose prescription will be 32 x 2.16 Gy to the high risk PTV and 32 x 1.75 Gy to the elective PTV.
15852919|NCT04019535|Device|physiological assessment with Volcano Verrata pressure wire (iFR)|physiological assessment of the coronary lesion will be made with both iFR and dFR. all clinical decisions will be made based on the results of iFR
15853073|NCT04018274|Drug|Ethinyl estradiol (EE) and levonorgestrel(LN)|Oral tablet containing 30 ug EE and 150 ug of LN
15853074|NCT04018261|Drug|Activated T-Lymphocytes|Activated T-Lymphocytes will be infused intravenously in a single-dose
15852920|NCT04019522|Other|Acute Intermittent Hypoxia (AIH)|An oxygen monitor will continuously measure and record the fraction of inspired oxygen delivered to the subject. Inspired fraction of oxygen (FiO2) of the gas mixture will be individually adjusted using the valve settings to reach the targeted SpO2. The gas mixtures administered during the four sessions will be 21% O2 (target SpO2 = 95%), 17% O2 (target SpO2 = 92%), 13% O2 (target SpO2 = 87%) and 9% O2 (target SpO2 = 82%).
15852921|NCT04019509|Diagnostic Test|blood test|blood test for thyroid antibodies and thyroid function (TSH, FT4)
15852922|NCT04019509|Other|follow up treatment outcome|questionnaire for treatment outcome: pregnancy, no pregnancy, miscarriage, delivery
15852923|NCT04019496|Drug|antibodies against calcitonin-gene related peptide or its receptor|the study is observational and does not interfere with clinical routine. In lin with this notion, the intervention is chosen by the treating physician in a shared decision making process involving the patient
15852924|NCT04019457|Other|Dietary intervention|Dietary intervention: Participants receive dietary fibers for a defined number of days.
15852928|NCT04019431|Dietary Supplement|Whey protein, vegetable protein or animal protein|meal replacements or animal protein
15852929|NCT04019418|Dietary Supplement|Maltodextrin (carbohydrate)|A drink containing 300ml of water and 75g of maltodextrin
15852930|NCT04019418|Other|Exercise|30 minutes on a cycle ergometer working at 75% VO2 max
15852931|NCT04019418|Other|Rest|30 minutes laying on a bed
15852932|NCT04019418|Other|Water|A drink containing 300ml of water
15852933|NCT04019392|Device|Game Ready® device|The half leg boot sleeve of the Game Ready® device (CoolSystems, Inc., Alamda, CA) will be applied to each participants' lower leg and ankle for 30 minutes set on the medium pressure setting (5-50 mmHG).
15852934|NCT04019392|Other|Wetted Ice Bag with Elastic Wrap|A standard ice bag filled with 2000 mL of cubed ice and 300 mL of 5˚C water will be applied using an elastic wrap to each participants' lower leg for 30 minutes. An elastic wrap applied at approximately 75% percent tension starting distal to the treatment area and moving proximally overlapping by half will be applied over the wetted ice bag.
15852935|NCT04019379|Other|Low Calcium/High Phosphorus Diet|Controlled research diet of low calcium/high phosphorus
15852936|NCT04019379|Other|High Calcium/Low Phosphorus Diet|Controlled research diet of high calcium/low phosphorus
15852937|NCT04019366|Other|Balance Training|Experimental group received balance training on Biodex stability System along with traditional exercise program. During balance training on Biodex, patients were instructed to stand on the platform with bare feet with open eyes and both legs supported. Patients were looking forward to screen having hands hang by the sides. The patients were instructed not to change their feet position and balance the body. The handles were accessible for safety point. But touching the handles cancelled the trail. Total time of training was 10 minutes each set is of 3 minutes with 20 sec rest intervals.
15852938|NCT04019366|Other|Conventional Training|Control group has received traditional exercises i.e Quadriceps strength exercises, Hamstrings flexibility exercises and Balance exercises.
15852939|NCT04019353|Genetic|cf-DNA Collection|"For all consenting recipients undergoing kidney biopsy between 1 and 12 months post-transplant, a single tube of blood will be drawn (at the time of other blood draws so that there is no additional needle stick) to measure cf-DNA. The tube will be shipped to the California lab for determination of donor cf-DNA. For recipients whose biopsy shows AR, a tube of blood will be drawn at 2, 4, 6, and 8 weeks after initiation of anti-rejection treatment and similarly will be shipped to the California lab for determination of cf-DNA.
~Recipients whose exit biopsy shows ongoing inflammation and receiving additional anti-rejection therapy will have an additional exit biopsy additional cf-DNA determinations."
15852940|NCT04019340|Other|Education|Usual care as described for the CG will also be provided to the IG. Wound size measurement, wound care, and questionnaires will be provided by the institute's nurses. Usual care will be enhanced by a pluridisciplinary educational program
15852941|NCT04019327|Drug|Talazoparib|"Phase I maximum tolerated dose portion:
~Level 1, 2, 3 - 1 mg QD Days 1-6 Level 4, 5 - 1.25 mg QD Days 1-6 Level 6 - 1.5 mg QD Days 1-6"
15852942|NCT04019327|Drug|Temozolomide|"Phase I maximum tolerated dose portion:
~Level 1 - 37.5 mg/m2 QD Days 2-8 Level 2 - 75 mg/m2 QD Days 2-8 Level 3 & 4 - 100 mg/m2 QD Days 2-8 Level 5 & 6 - 125 mg/m2 QD Days 2-8"
15852943|NCT04019314|Procedure|Blood Collection|Samples for proEnkephalin PENK will be obtained daily and aliquots of these samples will be stored for later batch assays.
15852944|NCT04019314|Procedure|Blood Volume Analysis|A small amount of a radioactive isotope or tracer is injected and blood samples are taken at 6 time points during the test and analyzed.
15852945|NCT04019301|Other|Baduanjin Qigong, Community-based|The Community-based Qigong group, will attend one 75 minute long Qigong class per week for 12 weeks. Additionally, participants practice Qigong at home for 20 minutes a day, 3 days a week. Printed materials will be provided to guide home practice.
15852946|NCT04019301|Other|Baduanjin Qigong, Internet-based|The Internet-guided Qigong group will be given a computer tablet to access online Qigong classes. All participants assigned to this group will be provided with a tutorial to use the Qigong program by the research coordinator. Participants will be asked to follow a 40 minute long Qigong class twice a week for 12 weeks, and to practice an additional 20 minutes a day, 3 days a week. All sessions will be completed at home.
15852947|NCT04019288|Drug|Batiraxcept|Given IV
15852948|NCT04019288|Biological|Durvalumab|Given IV
15852949|NCT04019275|Behavioral|ENGAGE|ENGAGE blends social learning, guided discovery and skill training focused on community participation
15852950|NCT04019262|Radiation|Radiation Therapy|Radiation
15852951|NCT04019262|Drug|Temozolomide Oral Product|Oral Temozolomide (150mg/m^2 or 75 mg/m^2)
15852952|NCT04019249|Behavioral|Healthy Weight Coaching|Healthy Weight Coaching is a 52 week long web-based weight loss program consisting of weekly modules, exercises, peer support, and one-on-one coaching. It encompasses themes such as diet, physical activity, coping with stress, sleep, and general health.
15852953|NCT04019236|Other|visual analogue scale (VAS),Respiratory distress observational scale (RDOS) and other Nursing care|Distressed patient will be assessed by visual analogue scale(VAS) or respiratory distress observational scale.Nursing interventions will be done according to its causes as giving supplemental O2 therapy, pharmacologic therapy ,initiating positive pressure ventilation or change Ventilator settings (TV, PEEP, Inspiratory pressure ), Improve inspiratory muscle function by Nutrition, positioning or by minimizing use of steroids , clearing airway by Suctioning, Check O2 saturation level frequently and maintain O2 saturation between 95-100%, ,Raising the HOB (Head of the Bed), high Fowler's ,Give pain medications as prescribed or diuretics as ordered and If thick secretions increase oral fluids intake
15852954|NCT04019223|Diagnostic Test|anti-tissue transglutaminase group|Determination of anti-tissue transglutaminase IgA antibodies serum level.
15852955|NCT04019223|Diagnostic Test|biopsy group|Intestinal biopsy for histopathology study the jejunal histopathological
15852956|NCT04019210|Procedure|MODIFIED TRABECULECTOMY|Rectangular scleral flap
15852957|NCT04019197|Drug|Semaglutide Injectable Product|semaglutide subcutaneous injection
15852958|NCT04019197|Drug|Placebo|placebo injection
15852959|NCT04019184|Drug|L-Alanyl/L-Glutamine|Immediately after randomization (not longer than 30 min after fulfilling eligibility criteria), patients will receive intravenous infusions with the investigational drug
15852960|NCT04019184|Drug|Placebo|Immediately after randomization (not longer than 30 min after fulfilling eligibility criteria), patients will receive intravenous infusions with the placebo
15852961|NCT04019171|Behavioral|exercise training|6 weeks of physical exercise training. 3 sessions per week. Session duration : 40 minutes. Self-regulated exercise intensity using Borg's ratings of perceived exertion (RPE)
15852962|NCT04019158|Device|Virtual reality headset|All participants will walk in the three conditions described earlier in this form
15852963|NCT04019145|Drug|EverX Posterior|fiber reinforced bulk fill resin composite
15852964|NCT04019145|Drug|Resins, Composite|incremental packing of Nanohybrid Resin composite
15852965|NCT04019132|Diagnostic Test|Muscle function test|Body measurements, power and strength tests of the knee extensor muscle, handgrip strength, functional capacity tests, objective measurement of physical activity (subgroup of older adults, n=50)
15852966|NCT04019119|Behavioral|Digital intervention|The information group will receive through a mobile application tips to reduce sedentary lifestyle and promote healthy living habits.
15852967|NCT04019106|Drug|Budesonide in bovine lipid extract surfactant (BLES)|Budesonide in bovine lipid extract surfactant
15852968|NCT04019093|Drug|Ethanol|A beverage containing dose of ethanol individually determined to raise a participant's breath alcohol concentration up to approximately 0.08 g/dL.
15852969|NCT04019093|Other|Placebo|A beverage that does not meaningfully increase breath alcohol concentration.
15852970|NCT04019080|Other|Anti-fibrostic drugs|The real-Life use of anti-fibrotic drugs in patients with idiopathic pulmonary fibrosis in Sweden
15852971|NCT04019067|Diagnostic Test|MCE first|"Patients randomized to the MCE first group will have a MCE deployed as soon as possible once confirmed to fast for at least 8 hours."
15852972|NCT04019054|Device|Intermittent Theta Burst Stimulation (iTBS), Ventromedial Prefrontal Cortex (vmPFC)|iTBS delivered to vmPFC for active treatment of spider phobia.
15852973|NCT04019054|Device|Intermittent Theta Burst Stimulation (iTBS), vertex|iTBS delivered to vertex for placebo treatment of spider phobia.
15852974|NCT04019041|Drug|bermekimab|bermekimab 2 mL (200 mg/mL) pre-filled syringe
15852975|NCT04019041|Drug|placebo|placebo 2 mL pre-filled syringe
15852976|NCT04019028|Device|low frequency rTMS + Navigation System|1Hz low-frequency rTMS stimulation over primary motor area using navigation system
15852977|NCT04019028|Device|only low frequency rTMS|1Hz low-frequency rTMS stimulation over primary motor area
15852978|NCT04019028|Device|Sham low frequency rTMS + Navigation System|1Hz low-frequency sham rTMS stimulation over primary motor area using navigation system
15852979|NCT04019015|Drug|Prothrombin Complex Concentrate, Human|Prothrombin Complex Concentrate (PCC) prepared from human plasma and contains blood coagulation factors
15852980|NCT04019015|Drug|Placebo|Normal saline solution
15852981|NCT04019002|Drug|Hyperpolarized 13C Pyruvate|"Dosage: Given at 0.43 milliliters/kilogram body weight of a 250 millimolar (mM) solution.
~Dosage Form: Intravenous injection over a period of about 1 minute
~Frequency: Once prior to each research magnetic resonance imaging procedure"
15852982|NCT04018976|Device|AVACEN 100|The AVACEN 100 pulls a -30mmHg vacuum around the hand from the wrist down and applies heat (108 Fahrenheit) to the palm
15852983|NCT04018976|Device|AVACEN 100 heat only|The AVACEN 100 applies heat (108 Fahrenheit) to the palm
15852984|NCT04018976|Device|AVACEN 100 sham|The AVACEN 100 does not provide heat or vacuum
15852985|NCT04018963|Procedure|Single nostril approach endoscopic transsphenoidal pituitary surgery|Single nostril approach endoscopic transsphenoidal pituitary surgery
15852986|NCT04018963|Procedure|Bilateral nostril approach endoscopic transsphenoidal pituitary surgery|Bilateral nostril approach endoscopic transsphenoidal pituitary surgery
15852987|NCT04018950|Drug|ETX2514|intravenous infusion
15852988|NCT04018950|Drug|14C-ETX2514|intravenous infusion
15852989|NCT04018937|Drug|Fludarabine|Fludarabine will be administered at 30 mg/m^2 IV daily for five days (Days -7 to -3).
15852990|NCT04018937|Drug|Alemtuzumab|A test dose of alemtuzumab, 3 mg, will be administered IV over 2 hours the first day. If the test dose is tolerated, administration of three treatment doses will begin within 24 hours. The three treatment doses will be administered on consecutive days. On the first day, 10 mg/m2 will be given, 15 mg/m^2 the second and 20 mg/m^2 the third. Alemtuzumab will be started between Days -22 and -20, but all doses (test dose and three treatment doses) should be completed by Day -18.
15852991|NCT04018937|Drug|Melphalan|Melphalan will be administered at 140 mg/m^2 IV on Day -3 following fludarabine administration.
15852992|NCT04018924|Device|Illumination with blue light (400-430nm) for 60 seconds with a power density of 120mW/sqcm (EmoLED device)|Debridement and Dressing or compressive dressing if needed
15852993|NCT04018911|Device|Hearing Aid with standard Noise Reduction (NR_1)|Hearing Aid with standard Noise Reduction (NR) Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs (ensures exact same hearing loss compensation for each intervention). Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The active comparator condition is the state of the art Noise Reduction principle.
15852994|NCT04018911|Device|Hearing Aid with NR_2|Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs. Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The experimental conditions (novel NR principle) vary in their parametrization to result in different degrees of noise suppression and good speech quality.
15852995|NCT04018911|Device|Hearing Aid with NR_3|Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs. Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The experimental conditions (novel NR principle) vary in their parametrization to result in different degrees of noise suppression and good speech quality.
15852996|NCT04018911|Drug|Hearing Aid with NR_4|Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs. Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. This experimental condition combines standard NR and novel NR principle to result in different degrees of noise suppression and good speech quality.
15852997|NCT04018885|Drug|ALA 2.5%|Topical treatment for photodynamic therapy, after drug incubation subsequent illumination with red light (72 J/cm2). 4 treatments at an interval of 10 (± 4) days.
15852998|NCT04018885|Drug|ALA 5%|Topical treatment for photodynamic therapy, after drug incubation subsequent illumination with red light (72 J/cm2). 4 treatments at an interval of 10 (± 4) days.
15852999|NCT04018885|Drug|ALA 10%|Topical treatment for photodynamic therapy, after drug incubation subsequent illumination with red light (72 J/cm2). 4 treatments at an interval of 10 (± 4) days.
15853000|NCT04018872|Drug|Itraconazole|Oral administration of itraconazole twice daily from completion of neoadjuvant chemoradiation until esophagectomy.
15853001|NCT04018859|Device|Platelet Rich Plasma Prep System|intradermal injections of platelet rich plasma to the eyebrows
15853002|NCT04018859|Drug|Saline|intradermal injections to the eyebrows
15853003|NCT04018846|Procedure|Revascularization using a BIOPROTEC Graft|It is about a routine care study not changing the usual follow-up of patients: postoperative visits after a Doppler ultrasonography made by a vascular Doctor in 1 month, 6 months, 12 months, 18 months and 2 years.
15853004|NCT04018833|Drug|Ranibizumab 0.5 MG/0.05 ML Intraocular Solution [LUCENTIS]|
15853005|NCT04018833|Drug|Aflibercept 40 MG/ML Intraocular Solution [EYLEA]|
15853006|NCT04018820|Other|Training program|12-week strength training program of the lower limbs consisting of 5 different exercises: Leg extension, leg press, hip abduction, squat and plantar flexion. All exercises were performed between 6 and 8 maximal repetitions.
15853007|NCT04018807|Other|Resource pamphlet|The pamphlet will list violence prevention, mental health, and substance abuse services.
15853008|NCT04018807|Behavioral|Remote Therapy|Remote therapy sessions will include mindfulness exercises and motivational interviewing techniques.
15853009|NCT04018794|Device|Behavioral/organizational skills intervention augmented with digital health application|Behavioral/organizational skills intervention with digital health application augmentation
15853010|NCT04018781|Other|medication reconciliation|"During hospitalization, the hospital pharmacist will carry out a pharmaceutical analysis for all patients included in the study, each time the prescription is changed and within a maximum of 24 hours (working days).
~If necessary, in consultation with the doctor in charge of the patient, the pharmacist may also propose a pharmaceutical interview to the patient at any time during his hospitalisation (e.g. proposal for the de-prescription of benzodiazepines, Proton Pump Inhibitors, etc., according to the recommendations in force)."
15853011|NCT04018768|Other|ibuprofen 600 mg|MRN ending in an EVEN # will receive ibuprofen 600 mg to be taken every 8 hours (TID) as needed (PRN) and oxycodone/acetaminophen (Percocet) 5 mg/325 mg for pain that is not adequately controlled by the ibuprofen.
15853012|NCT04018768|Other|Oxycodone/acetaminophen (Percocet) 5 mg/325|MRN ending in an ODD #: will receive the current standard of care postoperative pain management, which is Percocet 5 mg/325 mg every 6 hours PRN.
15853013|NCT04018755|Biological|anakinra|anakinra single-use prefilled glass syringes
15853014|NCT04018742|Other|Surgical puncture|Investigators propose to collect 20 abscesses. A collection of abscesses is performed systematically during the diagnostic for bacteriological analysis. There will be no further examination.
15853015|NCT04018729|Device|Zephyr Endobronchial Valve|Endoscopic lung volume reduction therapy.
15853016|NCT04018729|Biological|Marrow-derived mesenchymal stromal cell|Mesenchymal stem cells have anti-inflammatory, anti-fibrotic, microbicide and repair potential.
15853017|NCT04018716|Device|MTA|Indirect capping with MTA
15853018|NCT04018716|Device|Dycal|Indirect capping with Dycal
15853019|NCT04018703|Drug|Dexmedetomidine|loading dose 0.5-2.5ug/kg followed by continuous infusion 0.2-0.5ug/kg/h
15853020|NCT04018703|Drug|Midazolam|loading dose 30-50ug/kg followed by continuous infusion 10-30ug/kg/h
15853021|NCT04018690|Behavioral|Patients will be submitted to needle lavage, followed by the injection of 3mL of hylan and 1 mL of ropivacaine|"Patients with K&L 2 and 3 hip OA will be submitted to needle lavage, followed by the injection of 3mL of hylan, 0,5mL triamcinolone (10mg) and 1 mL of ropivacaine.
~Answer: WOMAC, Lequesne, VAS, EQ-5D-5L at inclusion, one week prior to surgery, 1st, 3rd, 6th and 12th months postoperatively.
~Submitted to evaluaton in the isokinetic dynamometer (Cybex 6000, Ronkokoma Lumex Inc.) where de amplitudes of movement of hip flexion, extension, abduction and adduction will be measures. Hip flexion, extension, abduction and adduction force will be assessed isokinetically at 60 degrees/second.
~Costs will be evaluated for cost-effectiveness and cost-utility analysis."
15853075|NCT04018248|Drug|BR101801 (Phase Ia)|Phase Ia (dose escalation):25 mg capsules and 100 mg capsules Planned doses are 50, 100, 200, 325, and 450 mg.
15855328|NCT03999762|Device|sample prep|Effectiveness of a sample preparation protocol
15853022|NCT04018690|Behavioral|Patients will be submitted to needle lavage, followed by the injection of 0,5mL triamcinolone (10mg) and 1 mL of ropivacaine,|"Patients with K&L 2 and 3 hip OA will be submitted to needle lavage, followed by the injection of 0,5mL triamcinolone (10mg) and 1 mL of ropivacaine.
~Answer: WOMAC, Lequesne, VAS, EQ-5D-5L at inclusion, one week prior to surgery, 1st, 3rd, 6th and 12th months postoperatively.
~Submitted to evaluaton in the isokinetic dynamometer (Cybex 6000, Ronkokoma Lumex Inc.) where de amplitudes of movement of hip flexion, extension, abduction and adduction will be measures. Hip flexion, extension, abduction and adduction force will be assessed isokinetically at 60 degrees/second.
~Costs will be evaluated for cost-effectiveness and cost-utility analysis."
15853024|NCT04018664|Drug|Nalbuphine HCl solution|nalbuphine solution administered at various strengths
15853025|NCT04018664|Drug|Placebo solution|Placebo
15853026|NCT04018651|Behavioral|PrEP Master Adherence Intervention|"The PrEP Master Adherence Intervention consists of 4 face to face individual education sessions and a series of telephone contacts to identify barriers and facilitators to optimal PrEP adherence over a six-month period. Each PrEP Master education session includes a review of an individualized plan to reduce risk, review of information about PrEP, and different discussion points. Key messages include:
~Importance of daily adherence;
~Three week delay for full effectiveness describing PrEP like taking the birth control pill;
~Condom use for other sexually transmitted infection (STI) prevention;
~Pregnancy prevention plans;
~Plans for follow up calls
~Referral to other treatment services if necessary"
15853027|NCT04018638|Other|B-FREE|Blood flow-restriction exercise enhancement (B-FREE) will be performed at home 3x/wk for 10 weeks. A blood pressure cuff will be inflated to partially occlude blood to the limb during light weight exercises involving knee extension, body weight squats, and walking.
15853028|NCT04018625|Behavioral|SMART Mom|SMART Pregnancy is an 8-session online stress management program offered in a group format. SMART Pregnancy is an adaptation of the Stress Management and Resiliency Training Program (Park et al., 2012).
15853029|NCT04018625|Behavioral|Mama Support|Participants will be enrolled in an 8-week time and attention matched, process-based support group.
15853030|NCT04018612|Drug|Ofirmev Injectable Product|Ofirmev Injectable Product (Acetaminophen)
15853031|NCT04018612|Other|Placebo|IV Saline
15853032|NCT04018599|Drug|40 mg MSB11022|Single dose, as a solution, administered subcutaneously, using an auto-injector.
15853033|NCT04018599|Drug|40 mg MSB11022|Single dose, as a solution, administered subcutaneously, using a pre-filled syringe.
15853034|NCT04018586|Device|AVACEN 100|AVACEN 100 pulls a -30mmHg vacuum around hand from wrist down and applies heat (108 farenheit) to the palm and will be applied for 30 minutes
15853035|NCT04018586|Device|AVACEN 100 Heat Only|AVACEN 100 applies heat (108 Fahrenheit) to the palm and will be applied for 30 minutes
15853036|NCT04018586|Device|AVACEN Sham|AVACEN 100 neither heats nor pulls a vacuum to hand
15853037|NCT04018573|Behavioral|PATHS Sexual Communication Toolkit|The PATHS Sexual Communication Toolkit is a self-guided, online intervention. The toolkit is comprised of 6 modules, covering a range of topics relevant to increasing parents' motivation, self-efficacy, and intention for communicating about sex. Material is presented in a variety of modalities (e.g., text, videos of experts, videos of other parents describing their experiences). Parents set personalized goals for themselves regarding activities and conversations they want to have with their sons, selecting from a menu of options provided by the intervention. A 1-month booster module queries parents about whether they have achieved their goals, and provides customized content to support the behaviors parents have yet to enact.
15853038|NCT04018573|Behavioral|Parent Support Film|"Lead with Love is a 35-minute education entertainment film created to provide support, information, and behavioral guidance to parents of lesbian, gay, or bisexual (LGB) children. Drawing from stage-based models of behavior change, and social cognitive theory, it aims to help parents progress through the process of coming to accept their child's sexual orientation, recognizing the importance of their behaviors and reactions to their child's health, and accepting their child's sexual orientation, and engaging in behaviors that are more supportive and less rejecting. This is achieved by telling the true stories of four families and how they responded to the news that their child was LGB, and by having experts (psychologists, teachers, clergy) provide information and guidance."
15853039|NCT04018560|Behavioral|Al-Anon Intensive Referral (AIR)|AIR is intended to facilitate Al-Anon participation.
15853040|NCT04018547|Device|Patient wears a wrist sensor oximeter device for one to two nights.|Patients will be asked to complete a study questionnaires of STOPBANG, SCI-8 (Sleep Condition Indicator-8 questionnaire for insomnia), Epworth questionnaires and medical history. The clinician will record blood pressure, pulse rate and regularity, body mass index and neck circumference. Subjects will be required to wear the wrist sensor pulse oximeter for 1-2 nights. The Oxitone 1000M device measures pulse rate, blood oxygen saturation and movement. The oxygen desaturation events from the wrist sensor device will be statistically compared with the diagnosis assessed using the conventional PPG oximetry, Peripheral Arterial Tonometry and clinical assessment. (clinicians will be masked when analysing the data from the wrist sensor pulse device).
15853041|NCT04018534|Behavioral|Standard Verbal/Written Education|This patients as control group received a standard printed educational material assisted with verbal information in accordance with British Orthodontics Society (BOS) educational goals.
15853042|NCT04018534|Behavioral|Video Assisted Education|The video training consisted of two separate sessions, each one lasting 5 minutes, one about the treatment materials and the other about the oral hygiene successively and in compliance with the British Orthodontics Society (BOS) educational obligations. All of the candidates were allowed to rewind and watch the video presentation until they reach all of the educational goals. The accomplishment of the educational goals was documented through a written examination form filled in by the candidates themselves. All of the candidates have rated fullscore in the written examinations on both topics.
15853076|NCT04018248|Drug|BR101801 (Phase Ib)|Phase Ib (dose expansion):25 and 100 mg capsules Doses administered will be determined from Phase Ia data.
15853077|NCT04018196|Other|motor imagery as training manual task|They will have a motor imagery as training manual task for 30 minutes. They will have 3 tests for performing manual task before training (pretest) and after training (post-test).
15853169|NCT04017494|Diagnostic Test|Cardiac Magnetic Resonance Imaging|Cardiac Magnetic Resonance Imaging (non-invasive, with i.v. application of contrast), awake or (if clinically indicated) in general anesthesia
15853043|NCT04018534|Behavioral|Hands-on Training|The hands-on training consisting of two separate sessions was performed by one of the authors (E.A). The first is about the treatment materials and the second one is about the oral hygiene successively. They are in accordance with the British Orthodontics Society (BOS) educational obligations. All of the patients were allowed to ask questions freely until they reach all of the educational goals. The accomplishments of the educational goals were documented through a written examination form filled in by the candidates themselves. All of the candidates have rated fullscore in the written examinations on both topics. The time requirements for all three different educational interventions were recorded separately.
15853044|NCT04018521|Behavioral|PPN|Delivery of Coordinated Specialty Care (CSC) for Y/YA in New York's state program for FEP, called OnTrackNY (OTNY).
15853045|NCT04018521|Behavioral|CSC Usual Care|standard of care provided to youth following first episode of psychosis
15853046|NCT04018508|Other|Massage|Massage intervention including effleurage, petrissage and energy work/Reiki at a pressure of 2 or less (Walton Pressure Scale)
15853047|NCT04018495|Device|Fitbit Tracker|Fitbit tracker; is an activity tracking product that is wireless-enabled wearable technology device that measures data such as the number of steps walked, heart rate, quality of sleep, steps climbed, and other personal metrics involved in fitness
15853048|NCT04018482|Other|Povidone Iodine|FDA-approved disinfectant for intravitreal injections
15853049|NCT04018482|Other|Hypochlorous Acid|FDA-approved disinfectant for intravitreal injections
15853050|NCT04018469|Other|No Interventions|No Interventions
15853051|NCT04018456|Other|Biodentine|Biodentine is calcium silicate based cement which is bioactive and inductive material. Biodentine will be applied as coronal plug material.
15853052|NCT04018456|Other|White MTA|MTA is calcium silicate based cement which is bioactive and inductive material. MTA is used in most cases of regenerative endodontics and it will be applied as coronal plug material.
15853053|NCT04018443|Diagnostic Test|common carotid artery diameter measurement|measurement of common carotid artery diameter will be carried out two times: the initial measurement (pre-infusion) which is followed by infusion of crystalloid solution (Ringer lactate) 30 ml/min till reaching a total infusion volume of 7 ml/kg body weight then another ultrasound measurement will be taken (prost-infusion). Between these sequential measurements, the patient position will not be changed. The percentage increase in CCA diameter will be calculated using the formula: [(dia-mpost/dia-mpre) × 100] - 100 [11].
15853054|NCT04018417|Drug|Amphotericin B|Drug concentration: 0.255 μg/mL
15853055|NCT04018404|Other|FRI CLINICAL PROGRAM|University Le Bonheur Pediatric Specialists and Le Bonheur Community Health and Well-Being, Maternal Child Department, have started the Family Resilience Initiative (FRI) in the ULPS General Pediatrics Clinic. This clinical program screens children 9 months to less than five years of age for ACES and SDH at the time of presentation for well child checks. There are two outreach coordinators who screen and enroll children attending clinic for a well-child check during morning clinics 3 to 4 days per week. Children with positive screens for ACES and/or SDH, and their adult caregivers, receive community resource referrals with warm handoffs to vetted organizations. In addition, if indicated, psychological services are offered for children based upon the presence of one or more of ACEs and current health and behavioral problems.
15853056|NCT04018391|Behavioral|Stepped care for nonadherence and depression|"Problem Solving for Depression and Adherence: A 6-session adherence and depression intervention based on a culturally adapted LifeSteps and Problem Solving Therapy for Depression.
~Stepped Care Assessment for Antidepressant Treatment: If a participant's depression score remains above threshold in Session 6, the study interventionist will refer the participant to a Research Mental Health Nurse for a psychopharmacological assessment to prescribe an antidepressant to augment Problem Solving for Depression and Adherence."
15853057|NCT04018391|Other|Enhanced Usual Care|Enhanced Usual Care: A combination of 1) clinic-provided adherence counseling, 2) access to providers trained in the World Health Organization Mental Health Gap Intervention Guide (mhGAP), 3) a letter to the participant's medical provider detailing the depression diagnosis, 4) access to the treatment components of the TENDAI intervention at no cost, after the participant has completed their 12-month follow-up assessment.
15853058|NCT04018378|Drug|varenicline tartrate 1mg (HGP1604, R) - varenicline oxalate 1mg (HIP1502, T), RT|varenicline tartrate 1mg (HGP1604) was used as a reference drug and varenicline oxalate 1mg (HIP1502) was used as a test drug.
15853059|NCT04018378|Drug|varenicline oxalate 1mg (HIP1502, T) - varenicline tartrate 1mg (HGP1604, R), TR|varenicline tartrate 1mg (HGP1604) was used as a reference drug and varenicline oxalate 1mg (HIP1502) was used as a test drug.
15853060|NCT04018365|Drug|Empagliflozin Tablets|The administration is oral administration with water before or after breakfast.
15853061|NCT04018339|Drug|Bardoxolone methyl|Bardoxolone methyl 5 mg capsules
15853062|NCT04018339|Drug|Placebo|Capsules containing an inert placebo
15853063|NCT04018313|Biological|CT-P39|150 mg/mL, Solution for injection in PFS
15853064|NCT04018313|Biological|EU-approved Xolair|150 mg/mL, Solution for injection in PFS
15853065|NCT04018313|Biological|CT-P39|150 mg/mL, Solution for injection in PFS
15853066|NCT04018313|Biological|EU-approved Xolair|150 mg/mL, Solution for injection in PFS
15853067|NCT04018313|Biological|US-licensed Xolair|150 mg/mL, Solution for injection in PFS
15853068|NCT04018300|Dietary Supplement|Ferrous sulfate|65 mg Fe as ferrous sulfate
15853069|NCT04018300|Dietary Supplement|Aspiron|65 mg Fe as iron-enriched koji culture, called AspironTM
15853070|NCT04018300|Other|Placebo|Contains maltodextrin.
15853071|NCT04018287|Other|HR-pQCT scans, BMD measurements, bone specific circulating microRNAs (miRNAs)|"HR-pQCT scans (XtremeCT, SCANCO Medical, Brütisellen, Switzerland) will be performed in all patients with HPP and all CTRL at the ultradistal radius and the distal tibia, using the manufacturer's standard protocol.
~Volumetric bone Mineral density (vBMD) will be carried out. The peripheral trabecular density adjacent to the cortex and the central medullary trabecular density will be automatically evaluated. Bone microstructure including trabecular bone volume fraction, trabecular number, trabecular thickness inhomogeneity of the network, cortical thickness and cortical porosity will be analyzed.
~Measurements will be carried out by two well-trained physicians and performed with the latest available software (software version 6.0). Daily crosscalibrations with standardized control phantoms (Moehrendorf, Germany) will be conducted for validation."
15853072|NCT04018274|Drug|PF-06651600|50 mg by mouth (PO) once daily (QD)
15853078|NCT04018196|Other|motor imagery as training motor task|"They will have a motor imagery as training motor task for 30 minutes before performing this task.
~They will have 3 tests for performing motor task before training (pretest) and after training (post-test)."
15853079|NCT04018196|Other|emotionally neutral film as training of manual task|"They will have to watch an emotionally neutral as training manual task for 30 minutes before performing this task.
~They will have 3 tests for performing manual task before training (pretest) and after training (post-test)."
15853080|NCT04018196|Other|emotionally neutral film as training of motor task|"They will have to watch an emotionally neutral as training motor task for 30 minutes before performing this task.
~They will have 3 tests for performing motor task before training (pretest) and after training (post-test)."
15853081|NCT04018170|Drug|Study drug|oral administration, once daily. The doses will be ascending per cohort from 10 mg to 600 mg
15853082|NCT04018170|Drug|Placebo|oral administration, once daily. The matching placebo doses will be ascending per cohort from 1 to 4 tablets
15853083|NCT04018157|Drug|"Ketamine and dexmedetomidine and propofol and 0.9%saline"|patients will receive single intravenous bolus of combination from ketamine 0.5mg/kg and dexmedetomidine 1ug/kg in one syringe diluted in 10 ml 0.9% saline.
15853084|NCT04018144|Diagnostic Test|Gingiva Biopsy Sampling|Gingival samples of healthy individuals were collected by gingivectomy or crown lengthening procedure in the routine treatment protocol or before orthodontically indicated tooth extraction. Gingival samples of periodontitis patients were obtained during the scaling and root planning procedure. Posterior maxillary teeth (#4, #5, #6, and #7) were chosen for gingival sampling.
15853085|NCT04018131|Drug|Cimetidine|Antihistamine 2 antagonist
15853086|NCT04018131|Drug|Placebos|Placebo drug
15853087|NCT04018118|Biological|Biological sample|Additional blood samples for biobanking
15853088|NCT04018105|Other|Oral glucose tolerance test (OGTT) with or without metformin|Each participant will have 3 OGTT, one without metformin, one with metformin30 minutes before the test, one with metformin 60 minutes before the test. The order for each test will be randomized.
15853089|NCT04018092|Device|Active NIR-PBM|See Experimental arm for description.
15853090|NCT04018092|Device|Sham NIR-PBM|See Sham Comparator arm for description.
15853091|NCT04018066|Dietary Supplement|GP-SPI|grape polyphenol-soy protein isolate complex (GP-SPI)
15853092|NCT04018053|Drug|18F-fluciclovine|18F-fluciclovine is a new radiotracer. This radiotracer targets amino-acid transporters, which are overexpressed in multiple cancers.
15853093|NCT04018053|Device|PET/CT|Positron emission tomography/computed tomography (PET/CT) uses small amounts of radioactive materials called radiotracers, a special camera and a computer to help evaluate organ and tissue functions.
15853094|NCT04018040|Other|Lacto-ovo vegetarian diet|Lacto-ovo vegetarian diet inclusive of dairy and eggs
15853095|NCT04018027|Drug|difelikefalin 0.25 mg|Oral difelikefalin 0.25 mg administered twice daily
15853096|NCT04018027|Drug|difelikefalin 0.5 mg|Oral difelikefalin 0.5 mg administered twice daily
15853097|NCT04018027|Drug|difelikefalin 1.0 mg|Oral difelikefalin 1.0 mg administered twice daily
15853098|NCT04018027|Drug|Placebo|Oral Placebo administered twice daily
15853099|NCT04018014|Other|CT angiography|CT angiography in detection of pulmonary embolism
15853100|NCT04017988|Dietary Supplement|Ethanol Extracts of Porphyra Tenera(PTE10)|2 times a day, 2 capsules for 1 time, after breakfast/dinner meal, for 8 week
15853101|NCT04017988|Dietary Supplement|Placebo|Placebo for 8 week
15853102|NCT04017975|Drug|Fluorescite|1 mL of Fluorescite will be diluted into 1L of saline. Up to 5mLs of the 1:1000 diluted solution will be applied topically to the cardiac tissue prior to imaging.
15853103|NCT04017975|Device|Cellvizio 100 Series System with Confocal Miniprobes|The microscopy system will image cardiac tissue.
15853106|NCT04017949|Drug|Corticosteroid injection|1 cc (40 mg) of a corticosteroid (kenalog) is given
15853107|NCT04017936|Drug|Anakinra|Active Treatment
15853108|NCT04017923|Diagnostic Test|measurement of nasal tip support in different age groups.|Nasal tip resistances , were measured in all age groups with a digital Newton meter.
15853110|NCT04017897|Drug|The combination of radiotherapy with anti-PD1 (pembrolizumab or nivolumab)|Subjects with treatment naïve, surgically unresectable metastatic melanoma stages IIIB to IVM1c will be treated with combination of anti-PD1 (pembrolizumab or nivolumab) and radiotherapy.
15853111|NCT04017884|Combination Product|Remin Pro Forte|a combination of chemicals with natural products cream .
15853112|NCT04017884|Combination Product|Remin Pro|a combination of chemicals
15853113|NCT04017871|Other|MRI|MRI at baseline and J90
15853114|NCT04017871|Other|Electro-Encephalography-High Density (children with unilateral PC only)|Electro-Encephalography-High Density (children with unilateral PC only) at baseline and J90
15853115|NCT04017871|Other|3D and EMG analysis|3D and EMG analysis at baseline and J90
15853116|NCT04017871|Other|care and classic activities|physiotherapy and psychomotility. As needed weekly sessions of speech therapist or orthoptist and daily activities of the child.
15853117|NCT04017871|Device|Accelerometers|During 5 days a sensor at each wrist to quantify their movement.
15853138|NCT04017767|Device|AIH mask|Induced Intermitted hypoxia will be delivered via the AIH mask. The mask has two one-way valves restricting inspiration to the top valve and expiration to the bottom valve. Hypoxic and normoxic gas mixtures will be delivered through the top valve.
15853170|NCT04017494|Diagnostic Test|Blood draw for hematocrit and heart failure biomarkers|Approximately 10 ml of blood will be drawn before administration of contrast medium.
15853786|NCT04012359|Diagnostic Test|Chest radiography|Chest radiography to search for visible pleural edge, synonym with persistent pneumothorax
15853118|NCT04017858|Behavioral|Multiprofessional and educational Program prior to Total knee replacement TKA. (PARQVE TKA).|"Patients will participate in two days of about knee OA lectures two months apart, will also come to the hospital at months 1, 3 and 5 after the first class to consult about nutritional habits; at months 4 and 6 to participate in a group therapy session with the psychologists, 7 sessions with the physical therapy followed by 7 sessions with the physical educators team. Following this program, patients will be operated (total knee arthroplasty).
~Answer Womac, VAS, Lequesne, BMI and body fat percentage - at inclusion, one week prior to surgery, 1 and 6 months postoperatively.
~Days of hospital stay will be measured by the number of nights the patients stay in the hospital postoperatively and also days in semi-intensive.
~Minutes and type of physical activity - Answer at inclusion and six months postoperatively.
~Perform STS30 and TUG at inclusion, one week prior to surgery, 1 and 6 months postoperatively Costs will be evaluated for cost-effectiveness and cost-utility analysis"
15853119|NCT04017858|Behavioral|Patients will be submitted to total knee replacement.|"Patients will be submitted to total knee replacement, without Multiprofessional and educational Program Answer Womac, VAS, Lequesne, BMI and body fat percentage - at inclusion, one week prior to surgery, 1 and 6 months postoperatively.
~Days of hospital stay will be measured by the number of nights the patients stay in the hospital postoperatively and also days in semi-intensive.
~Minutes and type of physical activity - Answer at inclusion and six months postoperatively.
~Perform the STS30 and TUG at inclusion, one week prior to surgery, 1 and 6 months postoperatively"
15853120|NCT04017845|Diagnostic Test|FIT|Screenees were supplied with two fecal collection devices and asked to collect two specimens from two consecutive Different Bowel Movement Samples (DBMS) or, in case of infrequent bowel movements, from the Same Bowel Movement Sample (SBMS).Instruction stressed that after collection the device must be stored in refrigerator and transported in an iced pack within no more than 48h from sampling. After checking for sampling appropriateness, the received samples were analyzed by the FOB Gold/SENTiFOB method (Sentinel Diagnostics SpA, Milan, Italy), according to the previously validated procedural platform
15853121|NCT04017845|Procedure|Precolonoscopy cleansing regimen|Laxative stimulant two days prior to the cleansing regimen involves the intake of one 10 mg tablet of bisacodyl (Dulcolax, Sanofi,UK) at 18:00 for two consecutive nights.The evening before colonoscopy cleansing started with 2 doses (at 16:00 and 20:00) of one sachet Sodium picosulphate preparations (PICOPREP, Ferring Pharmaceutical Co., Ltd., Zhongshan, China), dissolved in150 mL of cold water, followed with five 240 mL portions of clear liquids within 3 h. The third dose is taken in the morning about 5 h prior to colonoscopy, followed with at least three 240 mL portions of clear liquids no later than 2 h before colonoscopy.
15853122|NCT04017845|Procedure|Conventional Colonoscopy|With the colonoscopists completely blinded regarding the FIT results, conventional colonoscopy examinations were conducted in the Endoscopy Unit of Al-Kindy Polyclinic. According to the five levels of competency proposed by the European guidelines, this unit is assigned as level 2, with the possibility of removing polypoid and sessile lesions <25 mm, providing there is good access. For flat lesions, larger sessile and polypoid lesions, and smaller lesions with more difficult access, the lesions were documented appropriately with the patients referred to higher competent units in order to be safely and expertly removed.
15853123|NCT04017845|Diagnostic Test|Histopathological examinations of screen-detected lesions|Adenomas were classified according to the modified revised Vienna classification for the European Guidelines. Advanced adenoma was defined as the presence of one of the following features: >10 mm diameter, tubulovillous or villous structure, and high-grade neoplasia. Polypoid adenocarcinomas were reported according to the TNM classification, while colorectal cancer associated with flat and/or depressed lesions were reported as non-polypoid lesions, and further classified by the Paris classification. Pathologic results of hyperplastic polyps, sessile serrated lesions or post inflammatory polyps were considered normal findings.
15853124|NCT04017845|Drug|Tribenoside 400 mg + lidocaine 40 mg suppositories|Treatment of hemorrhoids was initiated with tribenoside 400 mg + lidocaine 40 mg suppositories, once daily for up to 2 weeks.
15853125|NCT04017845|Drug|Diltiazem hydrochloride 2%/Nitroglycerin rectal ointment|Treatment of anal fissure was initiated with Diltiazem hydrochloride 2%/Nitroglycerin rectal ointment applied every 12 hours, for up to six weeks.
15853130|NCT04017819|Drug|18F-C-SNAT4|Radiotracer- Dose 10 mCi
15853131|NCT04017819|Procedure|Positron emission tomography (PET)/Computed tomography (CT) Scan|Positron emission tomography (PET)/Computed tomography (CT) Scan
15853132|NCT04017793|Behavioral|Mindfulness Based Stress Reduction|Structured 8-week training program teaching about increased mindfulness strategies and gentle stretching.
15853133|NCT04017793|Behavioral|Relaxation Group|8-weekly group discussion meetings reviewing relaxation techniques and other stress reduction strategies with an emphasis on social support.
15853134|NCT04017780|Device|Single-Limb Turbine-Driven Ventilator|Non invasive ventilation performed with a single limb circuit and intentional leak (vented mask) delivered with a turbine-driven ventilator (Astral 150 [ResMed]).
15853135|NCT04017780|Device|Double-Limb Intensive Care Unit ventilator|Non invasive ventilation performed with a double limb circuit and expiratory valve incorporated in the ventilator, delivered with a pediatric/neonatal intensive care unit ventilator (Babylog VN500, Draeger).
15853136|NCT04017780|Device|Double-Limb Turbine-Driven Ventilator|Non invasive ventilation performed with a double limb circuit and expiratory valve incorporated in the ventilator, delivered with a turbine-driven ventilator (Astral 150 [ResMed]).
15853137|NCT04017767|Procedure|Induced Acute Intermittent Hypoxia (AIH)|AIH will be administered on days 1-3. Each day entails 15 and 90 second hypoxic intervals (Fraction of Inspired Oxygen (FIO2) = 0.09) alternating with 60-second normoxic intervals (FIO2 = 0.21).
15853168|NCT04017507|Device|Manual toothbrush|Manual toothbrush used twice daily
15853246|NCT04016883|Other|Conventional web platform|The conventional web platform, which will contain the general content on stress coping techniques.
15853139|NCT04017741|Drug|Combined Depo-Medrone and Lidocaine|"Patients will be randomised 1:1 to receive the active or placebo arm. The nerve is located along the superior nuchal line, where it bilaterally lies medial to the occipital artery. The scalp is prepped with alcohol and using 23G needle, the IMPs are injected at a 90 degrees angle till the bony endpoint is obtained. A combination of 2 mls of 2% lidocaine and 80mg methylprednisolone will be administered.
~Patients who no longer receive any benefit will be crossed over to the placebo arm."
15853140|NCT04017741|Drug|Sodium Chloride 0.9% Inj|Patients will be randomised 1:1 to receive the active or placebo arm. The nerve is located along the superior nuchal line, where it bilaterally lies medial to the occipital artery. The scalp is prepped with alcohol and using 23G needle the 4mls of normal saline (0.9%) are injected at a 90 degrees angle till the bony endpoint is obtained. Patients who no longer receive any benefit will be crossed over to the active arm.
15853141|NCT04017728|Device|Conventional Percutaneous Vertebroplasty|The cement is injected into the bone metastases directly.
15853142|NCT04017728|Device|Percutaneous Vertebroplasty with Rotary Cutter|The rotary cutter is applied before the cement injection. Then, the cement is injected with lower pressure.
15853143|NCT04017715|Other|Experimental: warm up|"Phase 1 is dynamic stretching and running exercises which includes, A jogging ,B walking lunge and sweeps, C hip in and out running : jog 3 steps stop and do hip in/hip out for Phase 2 is strength and agility which includes A- squat, B- push-ups: wide palmer push-ups. C vertical jumps. D- lateral jump. E- nordic hamstrings,. F (a)- shoulder external rotations, F(b)- modified inverted rows, Phase 3 is balance and core strength which includes A- modified ankle discs, B - planks: standard forward planks 2 repetitions for 30secs. C- side planks: standard side planks on both sides 1 repetition for 20 secs. Da- bird-dog,Db- modified back extensions, Phase 4 is run sprint which includes A- run sprint: 100% speed running between running (20m) with 1 repetition"
15853144|NCT04017715|Other|Experimental: cool down|"Phase 1 is dynamic stretching and running exercises which includes, A jogging ,B walking lunge and sweeps, C hip in and out running : jog 3 steps stop and do hip in/hip out for Phase 2 is strength and agility which includes A- squat, B- push-ups: wide palmer push-ups. C vertical jumps. D- lateral jump. E- nordic hamstrings,. F (a)- shoulder external rotations, F(b)- modified inverted rows, Phase 3 is balance and core strength which includes A- modified ankle discs, B - planks: standard forward planks 2 repetitions for 30secs. C- side planks: standard side planks on both sides 1 repetition for 20 secs. Da- bird-dog,Db- modified back extensions, Phase 4 is run sprint which includes A- run sprint: 100% speed running between running (20m) with 1 repetition"
15853145|NCT04017715|Other|No intervention: control|sprint exercise and general stretching as conventional protocol as follows in star club
15853146|NCT04017702|Device|Expiron respirator|Respiratory volume monitor (RVM) (ExSpiron, is a non-invasive FDA approved device that monitors minute ventilation (MV) and provides an early indication of respiratory status in non-intubated patients. The system consists of a lightweight monitor, a patient cable, and a disposable electrode PadSet, which detects changes in breathing.
15853147|NCT04017676|Other|Supervision assissted by measures|In the weeks 10 and 13, about 72 hours after the meeting scheduled for that week, and before the next therapeutic session, there will be a structured training session (based on the recommendations of Krägeloh et al., 2015), based on information in the literature about the various questionnaires
15853148|NCT04017663|Other|Application of questionnaires|Application of questionnaires to identify characteristics and main barriers of patients
15853149|NCT04017650|Biological|Cetuximab|Given IV
15853150|NCT04017650|Drug|Encorafenib|Given PO
15853151|NCT04017650|Biological|Nivolumab|Given IV
15853152|NCT04017637|Behavioral|Resistance Training|Static resistance training including two arm and two leg movements will be performed twice per week for 12 weeks.
15853153|NCT04017624|Other|Fresh Truck with stipend|"Linkage to Community Partner Organization
~Investigators will partner with a community organization, Fresh Truck, that deploys mobile fresh produce trucks throughout Boston neighborhoods. Participants randomized to the intervention arm will receive a monthly stipend of $80 to purchase fresh produce available at any Fresh Truck mobile market location."
15853154|NCT04017624|Other|THRIVE screening and referral|The THRIVE screening tool includes questions to identify eight potentially unmet health-related social needs associated with health outcomes and healthcare utilization: housing and food insecurity, inability to afford medications, need for transportation, trouble paying for heat and electricity, need for employment or education, and difficulty taking care of children or other family members. The survey is written at a 3rd grade reading level, is available in multiple languages, and requires less than five minutes to complete. The paper screener consists of two parts: part one screens patients for health-related social needs in the eight domains. Part two asks patients to indicate the resources they want help accessing across the eight domains. Patients who request resources in one or more domains receive paper guides that describe available hospital and community resources to address the specific domain(s) indicated.
15853155|NCT04017611|Device|INVSENSOR00038|Noninvasive regional oximeter
15853156|NCT04017598|Dietary Supplement|Ferrous sulfate|60 mg elemental iron as ferrous sulfate
15853157|NCT04017598|Dietary Supplement|Ferrous Bisglycinate|18 mg elemental iron as ferrous bisglycinate
15853158|NCT04017598|Dietary Supplement|Placebo of microcrystalline cellulose|placebo
15853159|NCT04017585|Dietary Supplement|diet containing gluten|gluten will be added for 7 days to the low FODMAP/gluten free diet diet. After 1 week of wash-out, patients will switch (cross-over) to placebo for another 7 days
15853160|NCT04017585|Dietary Supplement|Diet containing placebo|Placebo will be added for 7 days to the low FODMAP/gluten free diet diet. After 1 week of wash-out, patients will switch (cross-over) to gluten for another 7 days
15853161|NCT04017572|Procedure|Automated peritoneal dialysis (APD)|Automated peritoneal dialysis (APD) using the Baxter HomeChoice Pro Cycler.
15853162|NCT04017559|Behavioral|Motivational Interviewing|A pharmacist trained in MI delivered three recorded MI sessions over 2 months, with follow up at 3, 4 and 6 months.
15853163|NCT04017546|Drug|CYC065|intravenous infusion
15853164|NCT04017546|Drug|Venetoclax|oral capsule
15853165|NCT04017533|Procedure|GMK Sphere TKR|Se earlier
15853166|NCT04017507|Device|Oscillating-rotating electric toothbrush|Oscillating-rotating electric toothbrush used twice daily
15853167|NCT04017507|Device|Side-to-side electric toothbrush|Side-to-side electric toothbrush used twice daily
15853171|NCT04017494|Diagnostic Test|Cardiopulmonary exercise test|In patients 8 years of age or older: on a cycle ergometer with breath-by-breath analysis, continuous ECG and SpO2 monitoring during exercise, after a baseline spirometry and bodyplethysmography
15853172|NCT04017494|Diagnostic Test|Exhalomics|Measurement of exhaled molecules by mass spectrometry; patients breathe into a mouthpiece for 15 seconds 6 times (total time requirement: about 5 minutes)
15853173|NCT04017494|Diagnostic Test|Quality of life questionnaire|Questionnaire to be filled out by the Patient regarding quality of life perception
15853174|NCT04017481|Other|Repetitive transcranial magnetic stimulation (rTMS)|The intervention intends to change the cortical plasticity in specific cortical areas. rTMS is a non-invasive exogenous neuromodulation technique that uses repetitive magnetic pulses administered in a specific area of the head in order to influence the connectivity of the underlying brain area.
15853175|NCT04017481|Other|EEG guided Neurofeedback (NFB)|The intervention intends to change the cortical plasticity in specific cortical areas. The NFB is a non-invasive endogenous technique that seeks the self-regulation of cortical activity through the information represented in a videogame which is used to interact with the subject.
15853176|NCT04017468|Drug|Vancomycin|Patients randomized into the treatment arm will receive 1-2 g of vancomycin powder (Vancocin® i.v.) which will be administered above the closed muscle fascia (suprafascially) before closing the subcutaneous tissue and skin. The dose of the drug will depend on the length of the skin incision: 1 g for incisions ≤ 20 cm, 2 g for incisions ≥ 20 cm.
15853177|NCT04017455|Drug|Atezolizumab|3 cycles of atezolizumab 840 mg
15853178|NCT04017455|Drug|Bevacizumab|3 cycles of bevacizumab 5mg/kg
15853179|NCT04017442|Drug|Preservative Free Morphine|After delivery of the baby patients will receive via the epidural catheter prior to its removal.
15853180|NCT04017442|Drug|Saline|After delivery of the baby patients will receive via the epidural catheter prior to its removal.
15853181|NCT04017429|Procedure|Open flap debridement with osteoplasty|Treatment of furcation grade III defect with open flap debridement followed by osteoplasty treatment. Osteoplasty includes altering the bone buccal to the furcation opening to >90 degrees relative to the apico-coronal axis of the tooth.
15853182|NCT04017429|Procedure|Open flap debridement without osteoplasty|Treatment of furcation grade III defect with open flap debridement only.
15853183|NCT04017416|Behavioral|I-PLAN|The I-PLAN is a behaviour change intervention that consists of; information on consequences of hearing aid use/non-use, reminder prompt and behavioural plan to promote hearing aid use.
15853184|NCT04017403|Drug|Bifidobacterium triple live capsule|Bifidobacterium triple live capsules, indications for acute and chronic diarrhea and constipation caused by intestinal flora imbalance, can also be used for the treatment of mild to moderate acute diarrhea, chronic diarrhea and indigestion, bloating, and adjuvant treatment of intestinal flora Endotoxemia caused by disorders.
15853185|NCT04017403|Drug|Placebos|Placebos were administrated as same as the bifidobacterium live capsule
15853186|NCT04017390|Drug|Theraworx Foam|Apply Theraworx Foam alone
15853187|NCT04017390|Drug|Placebo Foam|Apply placebo foam alone
15853188|NCT04017390|Other|Theraworx Foam and night splint|Apply Theraworx Foam and night time splint
15853189|NCT04017390|Other|Placebo Foam and night time splint|Apply placebo foam and night time splint
15853190|NCT04017377|Drug|Drug: Cisplatin; nab-paclitaxel|Drug: Paclitaxel for Injection（Albumin Bound). Other Name: Ke ai li, ZhusheyongZishanchun(Baidanbai Jiehexing)
15853191|NCT04017364|Device|PCB PTCA|Predilatation of coronary de-novo stenosis followed by a PCB
15853192|NCT04017364|Device|SCB PTCA|Predilatation of coronary de-novo stenosis followed by a SCB
15853193|NCT04017351|Other|Artificial Intelligence Virtual Assistant|Virtual assistance application for subjects to ask questions and get information regarding planned surgery
15853194|NCT04017338|Drug|Glecaprevir 300 MG / Pibrentasvir 120 MG Oral Tablet|A potent and effective antiviral medication that has recently been approved for use in Canada with over 99% cure rates.
15853195|NCT04017338|Drug|Ezetimibe 10Mg Oral Tablet|A cholesterol-lowering medication that also blocks entry of HCV into liver cells.
15853196|NCT04017338|Device|Ex Vivo Lung Perfusion|A technology that allows for the assessment and treatment of lungs prior to transplant.
15853197|NCT04017325|Other|no intervention (post study follow up)|No intervention (post study follow up)
15853198|NCT04017312|Device|High Frequency Chest Wall Oscillation|High frequency chest wall oscillation (HFCWO) therapy (also known as high-frequency chest-wall compression or HFCWC) is commonly prescribed to provide routine airway clearance in patients with bronchiectasis as well as other patients with a need for regular airway clearance therapy. HFCWO generates high velocity expiratory airflow. This airflow is thought to mobilize secretions by the sheer force created, effecting changes in rheology and moving mucus in a cephalad direction during the oscillation. The Vest® Airway Clearance System, a commonly used device, generates HFCWO using an air pulse generator and an inflatable garment that delivers pressure pulses to the thorax. These pressure pulses within the garment create HFCWO.
15853199|NCT04017312|Device|Oscillating Positive Expiratory Pressure (OPEP)|Oscillating PEP is an airway clearance technique, where the person blows all the way out many times through a device. These types of oscillating PEP devices work in two ways. Firstly, they use resistance to make it more difficult during the breath out, like non-oscillating PEP devices. Oscillating PEP devices also create vibrations when breathing out. The vibrations move mucus from the surface of the airways. After blowing through the device several times, the person will huff and cough to clear the mucus from the lungs.
15853200|NCT04017299|Other|CHOISIR|Every patient will evaluate each device after 15 minutes of distraction once or twice a day according to the patient's wishes.
15853201|NCT04017260|Procedure|open and closed approach|"The patients were hospitalized, and the site of the operation was shaved on the day of the surgery. All Patients were operated on under spinal anesthesia. Antibiotic was administered to all patients as prophylaxis 60 minutes prior to the surgery. An adhesive tape was used to part the buttocks. The patients were placed in the jack-knife position. (Fig. 1). Methylene blue was injected without pressure through the external opening to delineate the sinus. The operation site was cleaned with 10% povidone-iodine. All sinus tracts were resected en bloc via elliptical incision down to presacral fascia with meticulous hemostasis.
~Group A:The wound was closed with 0 polypropylene u-shaped sutures ."
15853247|NCT04016870|Device|Reconditioned Pacemaker|Devices from the three manufacturers below will be used.
15853202|NCT04017260|Procedure|Rhomboid flap technique|The patients were hospitalized, and the site of the operation was shaved on the day of the surgery. All Patients were operated on under spinal anesthesia. Antibiotic was administered to all patients as prophylaxis 60 minutes prior to the surgery. An adhesive tape was used to part the buttocks. The patients were placed in the jack-knife position. (Fig. 1). Methylene blue was injected without pressure through the external opening to delineate the sinus. The operation site was cleaned with 10% povidone-iodine. All sinus tracts were resected en bloc via elliptical incision down to presacral fascia with meticulous hemostasis.Rhomboid flap technique: involve closure of the defect after excision of all sinuses with Rhomboid flap of skin and subcutaneous tissue
15853203|NCT04017260|Procedure|Karydakis technique|The patients were hospitalized, and the site of the operation was shaved on the day of the surgery. All Patients were operated on under spinal anesthesia. Antibiotic was administered to all patients as prophylaxis 60 minutes prior to the surgery. An adhesive tape was used to part the buttocks. The patients were placed in the jack-knife position. (Fig. 1). Methylene blue was injected without pressure through the external opening to delineate the sinus. The operation site was cleaned with 10% povidone-iodine. All sinus tracts were resected en bloc via elliptical incision down to presacral fascia with meticulous hemostasis.the long axis of the ellipse is parallel to the midline and 2cm from it.undercutting incision is made along the whole length 1cm below the skin surface then unrolling the flap over the midline.
15853204|NCT04017260|Procedure|open technique|The patients were hospitalized, and the site of the operation was shaved on the day of the surgery. All Patients were operated on under spinal anesthesia. Antibiotic was administered to all patients as prophylaxis 60 minutes prior to the surgery. An adhesive tape was used to part the buttocks. The patients were placed in the jack-knife position. (Fig. 1). Methylene blue was injected without pressure through the external opening to delineate the sinus. The operation site was cleaned with 10% povidone-iodine. All sinus tracts were resected en bloc via elliptical incision down to presacral fascia with meticulous hemostasis.Open procedure involved a wide excision of the pilonidal sinus tract and healing by secondary intention.
15853205|NCT04017247|Drug|Oxytocin|Intermittent oxytocin Infusion
15853206|NCT04017247|Drug|Oxytocin|Continous oxytocin Infusion
15853207|NCT04017234|Other|frequency following response, eye exercise, and transcutaneous|frequency following response, eye exercise, and TENS for 3 times per week during 4 weeks
15853208|NCT04017221|Drug|Sodium-glucose cotransporter 2 (SGLT2) inhibitors|Current exposure to SGLT2 will be defined as a prescription for a SGLT2 inhibitor (canagliflozin, dapagliflozin, empagliflozin) alone or in combination with other antidiabetic drugs, excluding DPP-4 inhibitors and insulin.
15853209|NCT04017221|Drug|Dipeptidyl peptidase-4 (DPP-4) inhibitors|Current exposure to DPP-4 will be defined as a prescription for a DPP-4 inhibitor (alogliptin, linagliptin, saxagliptin, sitagliptin, vildagliptin) alone or in combination with other antidiabetic drugs, excluding SGLT2 inhibitors and insulin.
15853210|NCT04017221|Drug|Other treatment combinations|Current exposure to other treatment combinations will be defined as a prescription of other antidiabetic drugs (metformin, sulfonylureas, thiazolidinediones, GLP-1 receptor agonists, alpha-glucosidase inhibitors, meglitinides, insulin, or combinations of these drugs), current use of insulin (alone or combination with other antidiabetic drugs), and non-current use of antidiabetic drugs.
15853211|NCT04017208|Drug|ASP2713|Administered intravenously
15853212|NCT04017208|Drug|placebo|Administered intravenously
15853213|NCT04017195|Drug|EVRA patch (NGMN+EE) (Treatment A) (Reference)|A single transdermal contraceptive patch of EVRA (NGMN + EE) will be applied to the buttock (right or left) of participants on Day 1 of each Treatment period and is removed 7 days after patch application, that is, on Day 8.
15853214|NCT04017195|Drug|High molecular weight polyisobutylene (HMW PIB) patch (NGMN+EE) (Treatment B) (Test)|A single transdermal contraceptive HMW PIB (NGMN + EE) patch will be applied to the buttock (right or left) of participants on Day 1 of each Treatment period and is removed 7 days after patch application, that is, on Day 8.
15853215|NCT04017169|Other|No intervention as observational study|
15853216|NCT04017156|Procedure|implant installation|All site preparations will be performed deeper compared to the length of the implant so that the implant apex cannot reach the bottom of the osteotomy.
15853217|NCT04017143|Behavioral|HPV app intervention|Participants assigned to this group will receive an HPV app that targets a dyad of parent and a teen boy or girl.
15853219|NCT04017117|Procedure|under local anasthesia,Ridge Augmention of posterior atrophic mandible by using mix of autogenous bone graft and bone substitutes is used under PEEK mesh|comparing between PEEK mesh and Titanium mesh for augmentation of posterior atrophic mandible using mix of autogenous bone graft and bone substitute.
15853220|NCT04017104|Diagnostic Test|18F-FDG PET/CT|"For 18F-FDG as fasting period of 6 hours is required before the scan. Each study subject will have an intravenous catheter inserted. The subject will receive a bolus intravenous dose of the radiotracer from an approved study supplier site.The participant will rest in a comfortable chair for 20 minutes. The participant will then be taken to a designated washroom and asked to void prior to being scanned in order to clear excreted radiotracer activity from the urinary tract. The participant will then be taken to the PET/CT scanner.
~Subjects are positioned supine, arms down, and centered on the scanner bed and the PET/CT images will be acquired."
15853221|NCT04017104|Diagnostic Test|68Ga-DOTATOC PET/CT|Participants will not be encouraged to drink additional water due to the requirement to stay on the scanner for up to 90 minutes. There are no dietary restrictions. Each study subject will have an intravenous catheter inserted. The participants will then be taken to a designated washroom and asked to void, and will then be taken to the PET/CT scanner. A CT topogram will be acquired followed by very low dose whole body CT for attenuation correction and localization of PET emission data. The participant will receive a bolus intravenous dose of the radiotracer 68Ga-DOTATOC from an approved study supplier site. Simultaneously a 6 minute dynamic acquisition of the heart will be started, then followed by several whole body static acquisitions. After the DWB scan, participants may go to the washroom again and their vital signs will be recorded. After this, a new PET/CT acquisition, as specified in the 68Ga-DOTATOC PET/CT protocol, will immediately follow.
15853248|NCT04016870|Device|New Pacemaker|Devices from the four manufacturers below will be used.
15853249|NCT04016857|Procedure|RIPC|4 cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of arm cuff
15853250|NCT04016857|Procedure|Control|deflated cuff placed on the left arm for 40 min
15853222|NCT04017104|Diagnostic Test|18F-DCFPyL PET/CT|Participants will not be encouraged to drink additional water due to the requirement to stay on the scanner for 90 minutes of the DWB acquisition. They will be unable to use the washroom during this time. As with the main study, participants will be instructed to fast for 4 hours prior to their appointment. Each study subject will have an intravenous catheter inserted. The participants will then be taken to a designated washroom and asked to void, and will then be taken to the PET/CT scanner. The participant will receive a bolus intravenous dose of 18F-DCFPyL from an approved supplier. This will then be followed by several whole body static acquisitions for a total scan time that will not be longer than 90 minutes. After the scan is finished, the participant will be allowed to rest in a comfortable chair or bed for 30 minutes. The participants will return to the scanner room and undergo the planned PET/CT imaging described in the main study.
15853223|NCT04017091|Diagnostic Test|Virtual Reality Cognitive Training|Bimodal VR-Stroop (ClinicaVR: Apartment Stroop) Patient find themselves seated with a virtual apartment, where they see a living room, in front of a flat-screen TV set, a kitchen and a window. This intervention consisted of two Stroop conditions across all 8 sessions. In Condition 1 (Inhibition), Patients indicated when the color named (audio stimulus) matched the color shown (visual stimulus). Participants were to withhold their response in mismatched trials. In Condition 2 (Interference), Participants clicked the mouse when the color heard was the same as the ink color; not the word printed.
15853224|NCT04017078|Other|diagnosis of carotid artery calcification on digital panoramic radiograph|Suspected carotid arty calcifications findings were defined as one or more radiopaque mass adjacent to the cervical vertebrae at or below the intervertebral space between C3 and C4 on the DPR.
15853225|NCT04017065|Device|DePuy Synthes MAXFRAMETM system|Patients treated with the MAXFRAMETM system will be followed up from before the surgery until the removal of the device. All treatments are based on individual clinician's judgement and the patient characteristics. The registry does not dictate any specific treatment.
15853226|NCT04017052|Drug|FSME-IMMUN Vaccine|Booster with TBE vaccine (i.m.) FSME Immun
15853227|NCT04017039|Other|Targeted Sleep Intervention|
15853228|NCT04017026|Device|Implantation|Implantation of 6 mm short implants
15853229|NCT04017013|Procedure|Epidural Analgesia|"The epidural infusion will be as follows:
~Isobaric Bupivacaine 0.5% 40 cc
~Morphine 4 mg (1 ampoule up to 10 cc and 4 cc of the mixture will be applied)
~Saline solution 0.9% 156 cc.
~Total Volume: 200 cc.
~This mixture will be prepared by a nurse outside the research group outside the operating room once indicated.
~The infusion will be scheduled at 7 cc / hour per continuous infusion set and will be connected to the epidural catheter after its placement."
15853230|NCT04017013|Drug|Lidocaine Infusion|2% Lidocaine IV without epinephrine: 1 mg/kg/ hour for up to 24 hours, started immediately after anesthetic induction.
15853231|NCT04017000|Diagnostic Test|Bladder Shape Test|Capturing images of bladder under natural filling conditions images are analysed at a later date for shape change.
15853232|NCT04017000|Other|Calibration images|Capturing images of bladder under artificial filling conditions during Urodynamic assessment images are analysed at a later date to inform shape change technology.
15853233|NCT04016987|Behavioral|Automated structured education intervention based on an app and artificial intelligence|In the 24-week intervention period, the experimental group receives automated push notifications supported by artificial intelligent algorithm.
15853234|NCT04016974|Drug|Oral semaglutide|Semaglutide tablets once daily as follows: 3 mg for the first treatment period (day 1-28), followed by 7 mg in the second treatment period (day 29-56), followed by 14 mg in the third treatment period (day 57-84)
15853235|NCT04016974|Drug|Placebo|Placebo tablets once daily throughout the treatment period (day 1 to 84)
15853236|NCT04016961|Other|AAT - Dog|therapy dog added to inpatient PT and OT session
15853237|NCT04016961|Other|TAU - No Dog|PT and OT as usual without the addition of therapy dog
15853238|NCT04016948|Device|Probe-based confocal laser endomicroscopy optical biopsy|In the pCLE group, after intravenous injection of fluorescein, the optical biopsy will be performed, using a confocal miniprobe, to exam the rectal mucosa when the rectum transection is ready. The raters will analyse the CLE images to determine whether the distal margin is positive. In the IFS group, intra-operative frozen section will be performed at the site of distal margin after the rectum transection.
15853239|NCT04016948|Device|Intra-operative frozen section|In the pCLE group, after intravenous injection of fluorescein, the optical biopsy will be performed, using a confocal miniprobe, to exam the rectal mucosa when the rectum transection is ready. The raters will analyse the CLE images to determine whether the distal margin is positive. In the IFS group, intra-operative frozen section will be performed at the site of distal margin after the rectum transection.
15853240|NCT04016935|Other|Observational|Observational
15853241|NCT04016922|Other|Oral ferrous fumerate for Group A, Parenteral iron sucrose for Group B, Compatible blood transfusion for Group C|"Consent, history. US: fetal heart activity, placental site, fetal biometry, AFI, anomalies, Doppler: umbilical artery, MCA, fetal renal artery, C\U ratio.
~* Maternal Hb,US at time of first visit, 10 days later after initiation of treatment, at EDD .
~As part of routine medical care of these patients, they are managed as:
~A: give oral iron in the form of ferrous fumerate with the possible side effects. if Hb returns to normal, continue iron for 3 mon.
~B: admit to receive IV iron sucrose according to product literature allergic reaction may happen; antiallergic measures. C: give blood transfusion in the form of packed RBC. allergic and pyrogenic reaction and infection may occur. At delivery will be subjected to: examination, investigations, US."
15853242|NCT04016909|Procedure|aerobic exercise plus calorie restriction|both a 6-month aerobic exercise program (moderate intensity) and caloric restriction (12.5% energy deficit)
15853243|NCT04016896|Behavioral|WIdowed Elders' LIfestyle after Loss (WELL)|Digital monitoring; motivational health coaching; personalized feedback
15853244|NCT04016896|Other|Enhanced Usual Care|psychoeducation plus study assessments controlling for time and attention
15853245|NCT04016883|Other|Problem Solving Therapy offered through a web platform|Problem Solving Therapy offered through a web platform. There will be four sessions, during the first four weeks of treatment, and subsequent sessions are dedicated to refining problem-solving skills. Participants set treatment goals; different ways to reach goals are discussed and evaluated; action plans are created, and its effectiveness is evaluated to achieve the objectives. Participants are expected to implement plans and apply the problem-solving model to additional problems between sessions. In the last two sessions, participants create a relapse prevention plan using the problem-solving therapy model.
15853251|NCT04016844|Device|transcranial direct current stimulation|A tDCS device (Soterix) will deliver a small direct current through two sponge surface electrodes (5cm × 5cm, soaked with 15 mM NaCL). The positive electrode will be placed over the motor cortex representation of the more affected leg, and a second electrode will be placed on the forehead above the contralateral orbit.
15853252|NCT04016844|Device|SHAM|In the sham condition, the participants will receive the initial 30 seconds of stimulation, after which the current will be set to 0. The same tDCS device (Soterix) will be used.
15853253|NCT04016831|Behavioral|Mapping Enhanced Counseling (MEC)|a motivational enhancement clinical intervention derived from cognitive-behavioral models that addresses problem recognition, treatment motivation, thoughtful and objective decision making, and therapeutic engagement
15853254|NCT04016831|Other|Mapping Approaches to Prepare for Implementation Transfer (MAP-IT)|an implementation intervention to explore and address agency preparation needs in order to promote implementation success
15853255|NCT04016818|Drug|18F-FDG|Participant will be injected IV (intravenously) with 10 ± 2 mCi of 18F-FDG.
15853256|NCT04016818|Device|Breast-dedicated PET camera|Breast-dedicated PET camera designed by Stanford satellite radiochemistry facility
15853257|NCT04016805|Drug|Ublituximab|"recombinant chimeric anti-CD20 monoclonal antibody
~administered as an IV infusion"
15853258|NCT04016805|Drug|Umbralisib|"Phosphoinositide-3-kinase (PI3K) delta inhibitor
~Tablet form, to taken orally on a daily basis"
15853259|NCT04016805|Drug|Ibrutinib|"Bruton Tyrosine Kinase (BTK) inhibitor
~Tablet form, to taken orally on a daily basis"
15853260|NCT04016805|Drug|Venetoclax|"BCL-2 inhibitor
~Tablet form, to be taken orally"
15853261|NCT04016805|Drug|Acalabrutinib Oral Capsule|Kinase inhibitor, capsule form, to be taken orally
15853262|NCT04016792|Drug|Placebo|Placebo will be administered once daily
15853263|NCT04016792|Drug|200 mg SPN-812|200 mg SPN-812 will be administered once daily and compared to Placebo
15853264|NCT04016779|Drug|Placebo|Placebo will be administered once daily
15853265|NCT04016779|Drug|200-600 mg SPN-812|200-600 mg SPN-812 will be administered once daily and compared to Placebo
15853266|NCT04016766|Behavioral|Mobile app prepartying intervention|The intervention is comprised of a theoretically-informed and empirically-supported, brief, accessible, and personalized intervention to address prepartying drinking. the prepartying intervention app will be tailored toward an individual's personal goals, beliefs (perceptions, expectancies, self-efficacy), and behavior (protective strategies), and focus on the core components of brief interventions that have been cited as constructs that mediate the effects of multiple component intervention programs (e.g., correcting perceived norms, use of protective behavioral strategies, increased self-efficacy, challenging expectancies, feedback on blood alcohol level).
15853267|NCT04016753|Drug|BMS-986256|30 mg(6ml)
15853268|NCT04016753|Drug|Loestrin|1.5 mg Norethindrone and 30ug ethinyl estradiol
15853269|NCT04016740|Drug|Ropivacaine|Intraoperative bilateral PIFB block with 20 mL of 0.25% Ropivicaine on either side of the sternum after anesthetic induction but before surgical incision
15853270|NCT04016740|Drug|Ketamine|Intraoperative infusion
15853271|NCT04016740|Drug|Remifentanil|Intraoperative infusion
15853272|NCT04016740|Drug|Dexmedetomidine|Intraoperative infusion
15853273|NCT04016740|Drug|Rocuronium|Intraoperative intermittent bolus
15853274|NCT04016740|Drug|Propofol|Intraoperative infusion
15853275|NCT04016740|Drug|Sevoflurane|Intraoperative inhaled as needed
15853276|NCT04016740|Drug|Dexmedetomidine|Post-operative infusion
15853277|NCT04016740|Drug|Propofol|Post-operative infusion
15853278|NCT04016740|Device|EEG monitoring|Perioperative monitoring
15853279|NCT04016727|Biological|platelet rich plasma|Platelet rich plasma was prepared using patients own blood. 60 units of PRP was injected on one side of the arch using insulin syringe. Each patient served as his/her own control (the side with PRP injected) and experimental group (the side without PRP injected). Whether the right or left side served as control or experimental was determined by lottery method. Patients were recalled after 4 weeks and the measurements were repeated again between lateral incisors and canines at mid, cervical and incisal of the teeth and their mean was recorded.
15853280|NCT04016714|Drug|V114|15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F, serotype 6B and aluminum phosphate adjuvant in each 0.5 mL dose.
15853281|NCT04016714|Drug|Prevnar 13®|13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B in each 0.5. mL dose.
15853282|NCT04016714|Drug|Vaxelis™|Intramuscular 0.5 mL single dose
15853283|NCT04016714|Drug|M-M-R®II|Subcutaneous 0.5 mL single dose
15853284|NCT04016714|Drug|Varivax®|Subcutaneous 0.5 mL single dose
15853285|NCT04016701|Device|Floreo Joint Attention Module|Two sessions per week for eight weeks of the Floreo VR Joint Attention Module, delivered via a Google Cardboard compatible VR headset. Each session includes one or two 5-minute VR episodes and an intermission that is at least 3 minutes long
15853286|NCT04016701|Behavioral|Regularly Scheduled Therapy|therapy as regularly scheduled at therapy center
15853287|NCT04016688|Procedure|ESPB and TAP block|"bilateral TAP block: while the patient in the supine position, a linear ultrasound (US) transducer (Phillips Saronno Italy) is placed transversally on the anterolateral abdominal wall in the midaxillary line between the iliac crest and the costal margin identifying external oblique, internal oblique and transversus abdominis muscles. The TAP is between internal oblique and transversus abdominis.
~A 22-G needle (spinocan, B.Braun, melsungen AG, Germany) is introduced anteriorly to the transducer and advanced to reach the TAP between internal oblique muscle and transversus abdominis muscle. After careful aspiration to exclude vascular puncture, 20 ml 0.5 % bupivacaine is injected causing an elliptical separation of the two muscles. The same procedure is done on the other side."
15853288|NCT04016675|Other|Neoadjuvant Radiotherapy/Chemoradiotherapy Followed by Surgery|After assigned into the study group, subjects will be conducted with incisional biopsy. Based on the tumor type and tumor stage, subjects will be conducted with neoadjuvant radiotherapy/chemoradiotherapy followed by radical surgery and simultaneous orbital reconstruction. After surgery, adjuvant chemotherapy will be determined based on the tumor histology, local tumor invasiveness, proximity of the surgical margins from the tumor, and pronouncement of tumor margins on permanent section tissue review.
15853376|NCT04015908|Drug|Oxycodone|oxycodone 5-10 mg
15853289|NCT04016675|Other|Surgery Followed by Adjuvant Radiotherapy/Chemoradiotherapy|After assignment into the control group, subjects will receive radical surgery without simultaneous orbital reconstruction. Adjuvant radiotherapy / chemoradiotherapy will initiate within two weeks after surgery. Both the radiotherapy and chemoradiotherapy should be comparable between the study group and the control group when tumor characteristics in these two groups are identical.
15853290|NCT04016662|Device|Tandom t:slim X2 with HCL or PLGS|"The system components include the t:slim X2 with Control-IQ Technology and the Dexcom CGM G6. The modular control algorithm has a safety supervision module that limits insulin delivery to prevent hypoglycemia at all times. The algorithm gradually decreases hyperglycemia from bedtime to reach a target of 120 mg/dL by waking time. During awake hours, the control algorithm attempts to maintain glucose within a target range (112.5 to 160 mg/dL) with meal time insulin boluses delivered based on usual bolus procedures undertaken by patients on an insulin pump (Hybrid closed loop).
~The system components include the t:slim X2 with with Basal-IQ Technology and the Dexcom CGM G6. The PLGS System is able to stop and resume basal insulin delivery automatically in response to predicted or low sensor glucose values, thereby reducing the incidence and duration of hypoglycemic episodes. The pump includes the hypoglycemia minimization strategy that will issue insulin delivery commands."
15853292|NCT04016623|Device|1-day toric test contact lens|somofilcon A 1-day toric test contact lens
15853293|NCT04016623|Device|1-day toric control contact lens|somofilcon A 1-day toric control contact lens
15853294|NCT04016610|Device|Soliton's Acoustic Scar Reduction (SAR)|Treatment of keloid scars for the temporary improvement in appearance.
15853295|NCT04016597|Device|Jaeger Masterscreen TM|Single-breath nitric oxide lung diffusing capacity
15853296|NCT04016597|Device|HypAir Medisoft|Single-breath nitric oxide lung diffusing capacity
15853297|NCT04016584|Behavioral|Diabetes Pueblo|These adults will receive diabetes education, the Diabetes Pueblo Program, and will complete Curriculum (A), Diabetes Fundamentals, and Curriculum (B), Insulin Success.
15853298|NCT04016558|Behavioral|StreamLine|"StreamLine is an education/disease management program that focuses on systematic methods to identify and resolve specific blood glucose problems, primarily through changes in carbohydrate consumption, and use of basal and bolus insulin. Participants will attend a brief, four-hour meeting with a Certified Diabetes Educator (CDE) and, using standardized blood glucose data, will learn how to employ a five-point blood glucose management system to identify and resolve blood glucose problems (e.g., excursions, lows) that have the greatest HbA1c or hypoglycemic impacts.
~Participants will then meet individually (30 minutes) with their CDE to review their blood glucose data, identify a specific blood glucose problem, and use the five-point program to create a plan to address the problem. Four additional individual meetings (30 minutes) will occur at approximately two to three-week intervals to best support individualized and participant-tailored management-change efforts."
15853299|NCT04016558|Behavioral|TunedIn|"TunedIn utilizes emotion regulation-based strategies to help participants observe that how they feel affects what they do regarding diabetes management. Participants will attend two highly interactive group workshops (6 hours followed by 2 hours) facilitated by a psychologist or social worker experienced in diabetes. Each will identify and discuss common emotional responses related to blood glucose management (e.g., over-reacting, avoiding, and lack of mindfulness).
~Between the two workshops (two weeks), participants will complete a feeling log to document feelings, situation/context, and resolution around specific management events. Two individual meetings with the interventionist (30 minutes) will allow participants to identify and address a specific diabetes distress-related problem. Four web-based video group meetings (60 minutes, monthly) will continue to support participants over time."
15853300|NCT04016558|Behavioral|FixIt|"FixIt combines components of StreamLine and TunedIn to allow participants to explore feelings and expectations alongside the identification of problematic blood glucose patterns. StreamLine will be co-facilitated by a psychologist/social worker experienced in diabetes and a CDE. Participants will attend two group workshops (six hours followed by four hours), separated by two weeks.
~Between the two workshops, participants will record their blood glucose data and keep a parallel feeling log to provide context. Four individual meetings with an interventionist (30 minutes) will allow participants to identify and address a specific blood glucose problem and create a plan to address it. Full discussion of diabetes distress-related aspects of the plan will take place to enhance mindfulness and identify typical emotion regulation strategies to ease problem resolution. Three web-based video group meetings (60 minutes, monthly) will continue to support participants over time."
15853301|NCT04016545|Device|Low profile endoprothesis (Navion Medtronic, NBS Low Profile Bolton Terumo)|Aortic aneurysm exclusion through endovascular procedure
15853302|NCT04016532|Dietary Supplement|Personalized dietary management at home|"Personalized dietary management at home to improve nutritional status.
~Four (J7, J30, J60 and J90 for non-undernutrition patients) or five Home visits (J7, J15, J30 and J90 for undernutrition patients or at risk of undernutrition) by professional dietitians from Saveurs & Vie over a period of 3 months after discharge from the hospital: personalized dietary advice and recipe sheet.
~There will be no change in medical prescriptions"
15853303|NCT04016519|Other|Gastrostomie|"Gastrostomy involves creating an opening between the skin and the stomach. It allows the administration of nutrition solutes or food directly into the stomach without passing through the mouth and esophagus. It is a method widely used since the 1980s for enteral nutrition.
~In the field of pediatrics, gastrostomy is considered in chronic diseases when enteral nutrition is necessary in the long term."
15853304|NCT04016506|Other|nutritional questionnaire|nutritional questionnaire is given to the patient after the injury
15853305|NCT04016493|Procedure|Connective tissue graft|The patient received 600 mg of ibuprofen (paracetamol 1 g in case of allergy) prior to surgery, and chlorhexidine mouthwash 0.2% was provided for 2 min. Patients received local anaesthesia at the donor and recession sites (articaine hydrochloride 7200 mg/1.8 ml, adrenalin 1800 mcg/1.8 ml). CTG harvesting was performed prior to the preparation of the reception site to avoid any bias. The graft dimension was calculated according to the recession dimensions; a minimum of 3 mm of the graft was submerged mesially, distally and apically. The CTG was harvested from the palate with single edge incision and sutured with 4.0 silk. The patient was subsequently assigned randomly to the control (CAF+CTG) or the test group (TUN+CTG).
15853377|NCT04015908|Drug|Percocet|Percocet (oxycodone 5mg/acetaminophen 325 mg)
15853306|NCT04016480|Device|High Flow Nasal Cannula|High Flow Nasal Cannula will be set at 60 liters per minute of air/oxygen admixture to reach a peripheral oxygen saturation equal or greater than 94%
15853307|NCT04016480|Device|Conventional Oxygen Therapy|Conventional Oxygen Therapy will be administered through nasal cannula with a oxygen flow set to achieve a peripheral oxygen saturation equal or greater than 94%
15853308|NCT04016467|Other|Thoracic manipulation|High velocity, small amplitude thrust treatment to spine that elicits a neurophysiologic response.
15853309|NCT04016467|Other|Sham thoracic treatment|Hand placement on thorax without thrust.
15853310|NCT04016454|Procedure|Intervention|There will be one complete handover
15853311|NCT04016441|Other|Survey|Participants will complete a survey online
15853312|NCT04016428|Behavioral|OPTIMISM|Six-week online program that emphasizes mindfulness and skills for improving sleep during pregnancy.
15853313|NCT04016428|Behavioral|Sleep Education|Six-week online program that provides education on sleep during pregnancy.
15853314|NCT04016415|Behavioral|Mindfulness Based Stress Reduction|Subjects randomized to Mindfulness-Based Stress Reduction (MBSR) will receive the 8-week University of Massachusetts Authorized MBSR curriculum followed by monthly mindfulness boosters in Months 3 to 6. The University of Massachusetts MBSR curriculum was selected for the intervention, as it is the most standardized and researched mindfulness program that has been shown to reduce psychological distress in various patient populations.
15853315|NCT04016415|Behavioral|Stress Management Education|Subjects randomized to Stress Management Education (SME) will receive health education on nutrition (adapted for the type 2 diabetes population), exercise as gentle stretching to match yoga in MBSR, and other general health topics that may be relevant to the type 2 diabetes population such as sleep, time management, etc. Stress Management Education does not have any mindfulness in it. Stress Management Education was specifically created as a control condition for MBSR studies so it matches MBSR for time, social support, homework, etc.
15853316|NCT04016402|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|Clinical transcranial magnetic stimulation administered as part of usual care for the study population
15853317|NCT04016389|Drug|Cisplatin|Cisplatin is an antineoplastic agent that is commonly used for the treatment of cervical cancer.
15853318|NCT04016389|Drug|Carboplatin|Carboplatin is an antineoplastic agent that is commonly used for the treatment of cervical cancer.
15853319|NCT04016389|Drug|Paclitaxel|Paclitaxel is an antineoplastic agent that is commonly used in combination with cisplatin or carboplatin for the treatment of cervical cancer.
15853320|NCT04016389|Procedure|Trachelectomy|Surgery to remove the cervix but keep the uterus intact.
15853321|NCT04016376|Drug|PVB Protocol|Patient will be placed in the prone, lateral, or sitting position. With an ultrasound probe placed in the parasagittal or transverse position, the paravertebral space will be identified. Injections will be done in an in-plane manner relative to the ultrasound probe. Local anesthesia will be injected to cover T1-T6 dermatomes.
15853322|NCT04016376|Drug|PECS-1|For PECS-1, the patient will be placed in the supine position with an ultrasound probe placed inferolaterally starting at the mid-clavicular level the pectoralis major and minor will be identified. Injection of local anesthesia will be performed between the pectoralis major and minor
15853323|NCT04016376|Drug|Serratus|For the serratus block, the patient will be placed in the supine or lateral decubitus position and with an ultrasound probe, in the parasagittal plane, the serratus muscles will be identified. Injections will be done in-plane below the serratus anterior.
15853324|NCT04016363|Other|ProbeFix|ProbeFix vs. manual hold of the ultrasound probe during pharmacological stress-echocardiography examinations
15853325|NCT04016363|Other|Manual hold|ProbeFix vs. manual hold of the ultrasound probe during pharmacological stress-echocardiography examinations
15853326|NCT04016350|Behavioral|Exercise training with Inulin Propionate Ester|Supervised moderate intensity exercise training combined with Inulin Propionate Ester supplementation conducted for 4 weeks.
15853327|NCT04016350|Behavioral|Exercise training with placebo|Supervised moderate intensity exercise training combined with placebo conducted for 4 weeks
15853328|NCT04016337|Dietary Supplement|Beverages|The beverages were all made with lemon and maqui extracts, and different sweeteners
15853329|NCT04016324|Device|InterStim Basic Evaluation lead and foramen needle|Commercial devices within their intended use as described in approved Instructions for Use.
15853330|NCT04016311|Behavioral|Mindful Drinking/Eating Intervention|Participants will be individually guided during their dialysis session through: 1) a mindful drinking exercise, a meditation focused on the sensory experience of 3 sips of fluid, along with a discussion of the experience; and 2) a mindful eating exercise with select foods that are recommended for controlling thirst (i.e., hard candy, frozen fruits). Participants will be given directions for mindful drinking/eating and asked to practice mindful drinking/eating as often as possible but least once each day.
15853331|NCT04016285|Device|Aquamantys|The Aquamantys bipolar sealer is a device used during surgery to help reduce bleeding in the joint. The system uses radiofrequency energy and sterile saline (salt water) to close small blood vessels in the knee to help reduce bleeding.
15853332|NCT04016285|Device|Tourniquet|Standard of care for reducing bleeding during the total knee arthroplasty
15853333|NCT04016272|Device|Active tDCS|tDCS with a constant current intensity of 2 mA will be applied for 20 minutes per session daily for 2 weeks (Monday to Friday) via the Soterix 1x1 tDCS mini-CT Stimulator device (Soterix Medical Inc., NY) with headgear and saline-soaked surface sponge electrodes.
15853334|NCT04016272|Device|Sham tDCS|For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds.
15853335|NCT04016259|Device|Cranial Electrical Stimulation (CES)|CES will be applied for 60 minutes per session daily for 2 weeks (Monday to Friday) via the Alpha-Stim M Electromedical Products International, Inc., Mineral Wells, TX).
15853336|NCT04016259|Device|Sham-CES|For sham CES, the electrodes will be identical look and be placed in the same positions as for active stimulation, but the stimulator will not deliver electrical current.
15853337|NCT04016246|Drug|Propofol-Lipuro|sedation of babies < 32wGA with propofol / placebo before a LISA Procedure
15853338|NCT04016246|Drug|Placebos|injected to babies < 32wGA with propofol / placebo before a LISA Procedure
15853339|NCT04016233|Drug|Tenofovir douche|660 mg TFV in 125 mL hypo-osmolar solution
15857402|NCT03983239|Drug|Efavirenz|Efavirenz
15853340|NCT04016220|Drug|Budesonide|first nebulization of 0.5 mg of budesonide in association with terbutaline and ippratropium bromide followed by repetitive nebulization of 5 mg of terbutaline with 0.5 mg of budesonide at 20, 40, 60 and 120 min.
15853341|NCT04016220|Drug|normal saline|first nebulization of 2ml of normal saline as placebo comparator in association with terbutaline and ippratropium bromide followed by repetitive nebulization of 5 mg of terbutaline with 2 ml of normal saline at 20, 40, 60 and 120 min.
15853342|NCT04016207|Drug|Guanfacine|regular treatment
15853343|NCT04016194|Diagnostic Test|Lung function testing|Multiple-breath washout (MBW) is a safe, easy and sensitive lung function test using inert gases such as Nitrogen (N2) to assess efficiency of ventilation distribution. The latter can be estimated by the lung clearance index (LCI), an established study end-point in patients with CF
15853344|NCT04016168|Biological|Blood sample collection|Three additional blood tubes (3 x 8mL) will be collected for this study. They will be added to the traditional diagnostic assessment carried out for their IPF, during their consultation at the competence centre for rare lung diseases. These samples will be taken by a registered nurse in the presence and under the responsibility of the investigator.
15853345|NCT04016155|Device|Abbott FreeStyle Libre|Flash CGMS
15853346|NCT04016155|Device|Patient Own SMBG|Market SMBG
15853347|NCT04016142|Drug|Carboplatin-Paclitaxel adjuvant chemotherapy|"Patients will receive a first part of treatment corresponding to a standard of care (standard concomitant radio-chemotherapy, Part 1 of the study).
~Then, they will be included in the second part of the study for the second part of treatment (experimental adjuvant chemotherapy, Part 2 of the study), providing they fulfill eligibility criteria at this stage.
~The second part consists in 4 cycles of Carboplatin-Paclitaxel adjuvant chemotherapy (one cycle = 3 weeks of treatment and 1 free-week)"
15853348|NCT04016129|Biological|4SCAR-CD22/CD123/CD38/CD10/CD20/TSLPR|4SCAR-CD22/CD123/CD38/CD10/CD20/TSLPR Patients who have relapsed after CD19 CART immunotherapy or have CD19 negative B cell malignancies
15853349|NCT04016116|Drug|Pembrolizumab|Pembrolizumab IV every 3 weeks
15853350|NCT04016116|Drug|Ruxolitinib|Ruxolitinib po days 1-21
15853351|NCT04016103|Device|MY01 - Continuous Compartmental Pressure Monitor|Insertion of the MY01 device for up to 24 hours for continuous monitoring of compartment pressure
15853352|NCT04016090|Dietary Supplement|Folic Acid|Folic acid (5 mg)
15853353|NCT04016090|Other|Placebo|Placebo capsule
15853354|NCT04016077|Drug|PF-06651600 30 mg|PF-06651600 in 10 mg oral tablets will be administered on days 1 to 10.
15853355|NCT04016064|Procedure|Er:YAG LASER, Nd:YAG laser, elctrosurgery, conventional surgery|"Er: YAG laser (Fotana AT Fidelis III, Ljubljana, Slovenia) 200 mj, 10 Hz, 2 Watt and VLP (long pulse, 1000 μs); 1.3 mm diameter, 8 mm long cylindrical, a sapphire tip was used with air cooling and water irrigation.
~Nd: YAG laser (Fotana AT Fidelis III, Ljubljana, Slovenia) was applied at 4 watts, 50 Hz, 300 μm microfiber tip and SP (short pulse: 180 μs) settings.
~Electrosurgical (Servotome Classic System, High Frequency Surgical Equipment, Satelec, France).
~Conventional surgical method was applied with hand instruments and gingivectomy knives."
15853356|NCT04016051|Drug|Clarithromycin DST (125 mg)|Clarithromycin DST (125.0 mg clarithromycin / straw).
15853357|NCT04016051|Drug|Clarithromycin DST (187.5 mg)|Clarithromycin DST (187.5 mg clarithromycin / straw).
15853358|NCT04016051|Drug|Clarithromycin DST (250 mg)|Clarithromycin DST (250.0 mg clarithromycin / straw).
15853359|NCT04016051|Drug|Clarithromycin Syrup (125 mg)|Clarithromycin Syrup 2.5 ml (125 mg).
15853360|NCT04016051|Drug|Clarithromycin Syrup (187.5 mg)|Clarithromycin Syrup 3.75 ml (187.5 mg).
15853361|NCT04016051|Drug|Clarithromycin Syrup (250 mg)|Clarithromycin Syrup 5 ml (250 mg).
15853362|NCT04016038|Other|a psycho-social investigation|The design of this project is based partly on the UNBIASED international study and is based on an in-depth case study in a prospective and retrospective dimension of deceased cancer patients for whom sedation has been established, and this, during a given period in different care settings: home, care center, hospital and palliative care unit.
15853363|NCT04016025|Behavioral|Adherence to topical standard therapy assessed|Adherence defined as percentage of patients applying at least aimed daily dose
15853364|NCT04016012|Dietary Supplement|Local Zambian Foods|Each week, participants in the intervention group will collect a pack of foodstuffs to last a week from the research site. The packs will be adjusted according to the weight of the participant and daily recommended allowances. Packaging of foodstuffs will be done in the food service lab at the Mukuba University. Instructions on how to prepare and use the food will be given to the participants. All food Items will be labelled diabetic food to avoid intra-household sharing.
15853365|NCT04015999|Dietary Supplement|Microbiota Directed Complementary Food (MDCF)|MDCF2 with four complementary food ingredients (rationale: lead with evidence from Pre-POC clinical trials to optimize lead microbiota-directed complementary food prototypes for their ability to repair microbiota immaturity and positive effects on growth)
15853366|NCT04015999|Dietary Supplement|Ready to Use Supplementary Food (RUSF)|Rice-lentil based RUSF (rationale: reference standard of care for MAM; based on knowledge of its effects on the gut microbiota or microbiota immaturity)
15853367|NCT04015986|Dietary Supplement|Microbiota Directed Complementary Food-2|MDCF prototype with four complimentary food ingredients without powdered milk (rationale: lead with evidence from the recently completed pre-POC clinical trial of promoting growth promoting microbiota and positive effects on growth
15853368|NCT04015986|Dietary Supplement|Ready to Use Supplementary Food|Rice-lentil based RUSF (rationale: reference standard of care for post-SAM, MAM; based on knowledge of its effects on child growth and the gut microbiota)
15853369|NCT04015973|Dietary Supplement|High energy diet|An overfeeding regime of 135% required energy intake per day, set from baseline energy requirements consisting of high (saturated) fat snacks, added to the usual diet, supervised by a dietitian.
15853370|NCT04015960|Other|no intervention|qualitative research and patient reported outcome measure (PROm) development
15853371|NCT04015947|Device|CelluTome® Epidermal Harvesting System|split-thickness skin grafts from a matched bone marrow donor using the CelluTome® Epidermal Harvesting System
15853372|NCT04015921|Other|No intervention|There is no intervention. Participants will be asked to complete a questionnaire and computer-based tasks.
15853373|NCT04015908|Drug|Celecoxib|Celecoxib 100mg
15853374|NCT04015908|Drug|Acetaminophen|Acetaminophen 325mg
15853375|NCT04015908|Drug|Pregabalin|Pregabalin 50 mg
15853378|NCT04015895|Other|DEFCO tool|The Detection of social frailties and coordination of the path of patients in cancer: a new approach by an expert computer system DEFCO tool is questionnaire to identify their social vulnerabilities. A neural network instantly identifies the patient's fragility and sends the result by email to the professionals identified in the organization of each center. These professionals then relay to the social workers in order to take care of the patient's fragility.
15853379|NCT04015882|Other|Exercise therapy|The exercise therapy group will make by physiotherapist supervision.
15853380|NCT04015869|Drug|Allopregnanolone|neurosteroid
15853381|NCT04015869|Drug|Placebos|placebo
15853382|NCT04015856|Behavioral|Full TP intervention|CARE's Tipping Point initiative focuses on addressing the root causes of child, early, and forced marriage (CEFM) and promoting the rights of adolescent girls through community-level programming and evidence generation in Nepal and Bangladesh, as well as multi-level advocacy and cross-learning efforts across the globe. Tipping Point's approach focuses on synchronized engagement with different participant groups-including adolescent girls, adolescent boys, parents/community members, community leaders-around key programmatic pillars, and creates public spaces for all community members to engage in the dialogue. Tipping Point's approach relies on challenging social expectations and repressive gender norms and promoting girl-centric and girl-led activism to enable adolescent girls to identify and move into social spaces where they can challenge inequality.
15853383|NCT04015856|Behavioral|Light TP intervention|The Tipping Point project also has designed a social norms light package, which includes a subset of the social norms and activism components of the full package.
15853384|NCT04015830|Other|electroencephalography (EEG) and event related potentials (ERP)|This is an exploratory study of EEG/ERP measures in older African American and Whites with HIV
15853385|NCT04015817|Other|paramedical and non-pharmacological services|Paramedical and non-pharmacological services (work on positions, ventilatory education, use of a fan, pulmonary rehabilitation, stress management, mindfulness meditation, psychosocial services, possible support from the mobile palliative care team)
15853386|NCT04015804|Other|Clinical database|Creation of an ambispective (retrospective and prospective), multicentric and European clinical database for surgery with robotic assistance in rectal cancers with implementation in France and then in Europe
15853387|NCT04015791|Other|NOCISCAN-LS Disc MR Spectroscopy|The investigational Nociscan Suite is a software suite that works with existing high field MR systems and MRS pulse sequence via and optimized protocol to conduct MRS exam of lumbar discs. The software suite post-processes the NOCISCAN-LS disc MRS exam data to calculate ratios of spectroscopic signals at regions along the MRS frequency spectrum associated with certain chemicals that change with degeneration and pain
15853388|NCT04015778|Biological|Nivolumab|240mg Q2W or 360mg Q3W
15853389|NCT04015778|Drug|carboplatin|AUC 5, d1 every three weeks
15853390|NCT04015778|Drug|nab-paclitaxel|135 mg/m2, d1, 8
15853391|NCT04015765|Procedure|Hybrid Argon Plasma Coagulation and EMR procedure|Hybrid Argon Plasma Coagulation (h-APC) combines an ablation technique (APC) with the option for submucosal saline injection using a high-pressure water jet. The technique allows to lift dysplastic epithelium thus creating a safety cushion under the mucosa is lifted with a saline injection and then to ablate larger areas more thoroughly and with a higher energy setting, with a low risk for side effects or complications
15853392|NCT04015752|Diagnostic Test|culture from infected site|ESR ,CRP,CBC, Renal and Liver function will be done on admission and follow up Culture: On admission Urine and blood as well as sputum culture acc. To the cause of infection. Culture from suspected site of infection in catheter related infections.
15853393|NCT04015739|Drug|Bevacizumab (FKB238), Olaparib and Durvalumab (MEDI 4736) combination|"Patients will receive a combination of these 3 drugs :
~Bevacizumab (FKB238) 15mg/kg q3w IV, Olaparib 300mg BD Per Os; and Durvalumab (MEDI 4736) 1.12g IV q3w"
15853394|NCT04015700|Biological|Personalized neoantigen DNA vaccine supplied by Geneos Therapeutics|-The neoantigen DNA vaccines are also known as DNA plasmid vector expressing tumor-specific antigens.
15853395|NCT04015700|Device|CELLECTRA®2000 EP Device supplied by Geneos Therapeutics|CELLECTRA® 2000 Device is a system indicated for use to enhance the uptake and expression of plasmid-based biologics in order to enhance vaccine efficacy.
15853396|NCT04015700|Drug|Plasmid encoded IL-12|The INO-9012 vials will be supplied by Geneos Therapeutics
15853397|NCT04015687|Drug|AG-881|Supplied as uncoated tablets.
15853398|NCT04015687|Drug|Lamotrigine|Supplied as tablets of LAMICTAL® or generic equivalent.
15853399|NCT04015674|Other|Exercise group|Aerobic exercise on a stationary bicycle
15853400|NCT04015674|Other|Control group|In a rest
15853401|NCT04015661|Drug|Nab-paclitaxel|induction chemotherapy with nab-paclitaxel and nedaplatin followed by concurrent chemoradiotherapy
15853402|NCT04015648|Biological|ChAdOx1 Zika|Single dose of ChAdOx1 Zika at different concentrations: 5 x 10^9 vp, 2.5 x 10^10 vp, 5 x 10^10 vp
15853403|NCT04015648|Biological|ChAdOx1 Zika, ChAdOx1 Chik|Co-administration of ChAdOx1 Zika and ChAdOx1 Chik at different concentrations: 5 x 10^9 vp, 2.5 x 10^10 vp, 5 x 10^10 vp
15853404|NCT04015635|Other|None involved|NO intervention
15853405|NCT04015622|Drug|Enzalutamide|Enzalutamide 160 mg PO OD
15853406|NCT04015622|Drug|Docetaxel|Docetaxel 75 mg/m2 IV every 3 weeks
15853411|NCT04015596|Drug|Naproxen Sodium|Dosed by weight (10mg/kg), twice daily, for 8 weeks
15853412|NCT04015596|Other|Placebo|Participants take placebo pills twice daily, for 8 weeks.
15853413|NCT04015583|Behavioral|exergaming group|Exergame is 'exercise + game'. Treadmill exercise is traiditional aerobic exercise
15853414|NCT04015570|Biological|High Volume Plasma Exchange|PLASMA EXCHANGE is therapeutic procedure in which blood of the patient is passed through a medical device which separates plasma from other components of blood. The plasma is removed and replaced with a replacement solution such as colloid solution (e.g., albumin and/or plasma) or a combination of crystalloid/colloid solution.Plasma exchange leads to removal of abnormal circulating plasma factor or a physiologic factor produced in excess (IG, NH3,protein bond toxins )and also exert a immunomodulatory activity
15853415|NCT04015570|Other|Standard Medical Treatment|Standard Medical Treatment (Albumin+High caloric diet)
15853416|NCT04015557|Drug|Acetaminophen|Adult patients with homocystinuria due to cystathionine beta synthase (CBS) deficiency and controls will receive a single dose of Acetaminophen (1.5g) orally. Blood will be drawn at time 0, 2, 4, 6 and 8 hours after the acetaminophen dose to measure liver enzymes and markers of oxidative stress.
15853417|NCT04015557|Drug|N-acetylcysteine|Patients with homocystinuria due to cystathionine beta synthase (CBS) deficiency and controls will receive again a normal dose of acetaminophen (1.5g) orally and one hour later oral N-acetylcysteine (70 mg per kilogram of body weight). Blood will be drawn at time 0, 2, 4, 6 and 8 hours after the acetaminophen dose to measure liver enzymes and markers of oxidative stress.
15853418|NCT04015544|Dietary Supplement|Watermelon|Pureed whole (100%) watermelon
15853419|NCT04015531|Radiation|Conventional radiotherapy|50 Gy / 25 fractions / 5-6 weeks / Sequential boost of 10 Gy in 5 fractions, in case of conservative surgery.
15853420|NCT04015531|Radiation|Hypofractionated radiotherapy|40 Gy / 15 fractions / 3 weeks / Concomitant boost with total dose of 48 Gy in 15 fractions, in case of conservative surgery.
15853421|NCT04015518|Drug|Spesolimab|BI 655130
15853422|NCT04015518|Drug|Placebo|Placebo
15853423|NCT04015505|Behavioral|Cognitive Behavioural Therapy for older adults: wisdom enhancement 'timeline technique'|The intervention is comprised of five one-hour sessions of structured talking therapy, where participants create a timeline of their life with significant events included. Through dialogue with the therapist and structured worksheets, participants are encouraged to reflect on events in their life to recognise and develop qualities of resilience and self-compassion. They are then asked to use 'the wisdom of their years' to develop strategies to manage difficulties they are currently facing. Participants will also be asked to complete worksheets and try out new strategies between sessions.
15853424|NCT04015492|Biological|Damoctocog-alfa-pegol (BAY94-9027, Jivi)|Single dose, 50 IU/kg BAY94-9027 (IU: international Units)
15853425|NCT04015492|Biological|Rurioctocog alfa pegol (Adynovi)|Single dose, 50 IU/kg Adynovi
15853426|NCT04015479|Dietary Supplement|Peanut Protein Powder|Peanut protein powder will be provided to participants who will be instructed to consume 72g daily, mixed with water
15853427|NCT04015479|Behavioral|Full body resistance training|Participants will undergo supervised resistance training two times per week (5 exercises, 3 sets of 8-12 repetitions per set)
15853428|NCT04015453|Procedure|Mohs micrographic surgery|All participants will have received Mohs micrographic surgical treatment for a facial skin cancer.
15853429|NCT04015440|Behavioral|HBMT|Individual is presented with words with some letters missing and told to complete the word.
15853430|NCT04015440|Behavioral|Other Training|Alternative to HBMT training
15853431|NCT04015427|Device|implant crown|After the second 16 week period the screw-retained crowns will be (re-) inserted in all patients, single tooth x-rays taken and clinical baseline values obtained. Additionally, a soft tissue biopsy will be harvested at the time of insertion of the final screw-retained crown. Patients will be followed up for another 16-week period.
15853432|NCT04015414|Drug|Varenicline|190 patients will receive varenicline for 12 weeks and regular phone calls with brief counseling Tabex: 190 patients will receive cytisine for 25 days and regular phone calls with brief counseling
15853433|NCT04015414|Drug|Cytisine|190 patients will receive cytisine for 25 days and regular phone calls with brief counseling
15853434|NCT04015388|Device|iPro Continuous Glucose Monitoring|iPro device is a continuous glucose monitoring (CGM) FDA approved device. This CGM device consists of a small recorder which reports glucose values every five minutes. This recorder is connected directly to a glucose sensor. The glucose-oxidase based sensor measures extracellular fluid in the subcutaneous tissue. The tiny and flexible sensors are typically inserted just beneath the skin, usually in the abdominal area, but can also be placed in the buttock, or anterior or lateral thigh.
15853435|NCT04015375|Drug|Dapsone gel 7.5% (Torrent Pharmaceuticals Ltd)|Topical gel
15853436|NCT04015375|Drug|ACZONE® (dapsone) gel, 7.5% (Allergan, INC.)|Topical gel
15853437|NCT04015375|Other|Placebo for Dapsone gel 7.5% (Torrent Pharmaceuticals Ltd)|Topical gel
15853438|NCT04015362|Procedure|Sub-threshold intermittent pulsed magnetic stimulation|Application of sub-threshold intermittent pulsed magnetic stimulation to spinal cord
15853439|NCT04015362|Procedure|Sham|Application of sham magnetic stimulation to spinal cord
15853440|NCT04015349|Diagnostic Test|Polysomnography|The polysomnography (referred to as type I) allows assessing several sleep physiologic parameters (eg, EEG, electrooculogram, electromyogram, electrocardiogram, airflow, respiratory effort, oxygen saturation), whereas audio-video recording enables documenting tooth-grinding sounds and distinguishing between rhythmic masticatory muscle activity (RMMA) and orofacial (eg, swallowing) and other muscular activity (eg, head movements) during sleep. Based on the RMMA index (number of episodes per hour of sleep), sleep bruxism is diagnosed when RMMA episodes are greater than or equal to 2 (low-frequency SB, mild bruxism) or RMMA episodes are greater than or equal to 4 (high-frequency SB, severe bruxism)
15853441|NCT04015336|Biological|E7 TCR|The dose of E7 TCR T cells will be 3 x 1010 TCR+ T cells (unless fewer cells are generated) administered once.
15853442|NCT04015323|Device|Interferential current|An electrotherapy current with different carrier frequencies
15853443|NCT04015310|Device|Quantitative Multi parametric MRI and enhanced MRCP|Patients will have quantitative MRI and enhanced MRCP on addition to their standard of care
15853444|NCT04015297|Diagnostic Test|raman analysis|negative or pozitive
15853445|NCT04015284|Procedure|Suprascapular Nerve Block + Posterior Cord Block|The patient lies supine with the head turned to the contralateral side to the block. Using a linear high-frequency ultrasound probe, the proximal suprascapular nerve is visualized before it turns toward the suprascapular notch. It is blocked using 5mL of ropivicaine 0.5%. The posterior cord is readily visualized when performing an infraclavicular brachial plexus block. It is blocked using 10mL of ropivicaine 0.5%.
15853446|NCT04015284|Procedure|Interscalene Brachial Plexus Block|The patient lies supine with the head turned to the contralateral side to the block. Using a linear high-frequency ultrasound probe, the interscalene groove is visualized along with the roots of the brachial plexus. The block is performed with 15mL of ropivacaine 0.5%.
15853447|NCT04015271|Behavioral|Action Observation + Repetitive Task Practice|Observing a video of another person performing a functional task and physically repetitively performing the same task for upper extremity hemiparesis
15853448|NCT04015271|Behavioral|Placebo Video + Repetitive Task Practice|Observing a video of static images and physically repetitively performing functional task for upper extremity hemiparesis
15853449|NCT04015258|Dietary Supplement|Blueberries|fresh spanish blueberries
15853450|NCT04015258|Dietary Supplement|Blueberry powder|freeze-dried blueberry powder
15853451|NCT04015258|Dietary Supplement|Blueberry components capsules|encapsulated blueberry components (microcrystalline cellulose powder in actual)
15853452|NCT04015245|Drug|Stronger Neo-Minophagen C|intravenous injection after TACE
15853453|NCT04015232|Combination Product|INTP5|INTP5, a pegfilgrastim biosimilar to US Neulasta.
15853454|NCT04015232|Combination Product|US Neulasta|US Neulasta: FDA approved pegfilgrastim innovator product.
15853455|NCT04015219|Device|Self retained cryopreserved amniotic membrane|PROKERA SLIM
15853456|NCT04015219|Other|lifitegrast ophthalmic solution|Xiidra® (5% lifitegrast ophthalmic solution, Shire, Lexington, MA)
15853457|NCT04015206|Other|Group Interpersonal Psychotherapy|Group Interpersonal Psychotherapy added to usual treatment (Pharmacotherapy + clinical management)
15853458|NCT04015193|Procedure|Single-port thoracoscopic sympathicotomy (patient care)|Single-port thoracoscopic sympathicotomy will be performed as part of patient care, data will be collected of patients undergoing this procedure
15853459|NCT04015180|Drug|Eylea (Aflibercept, BAY86-5321)|Treatment administered in 20090. Solution in a sterile glass vial, Dose A, IVT injection.
15853460|NCT04015180|Procedure|Laser photocoagulation|Treatment administered in 20090. Transpupillary conventional laser ablative therapy
15853461|NCT04015167|Device|T2 Alpha Tibia Nailing System|The T2 Alpha Tibia Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved.
15853462|NCT04015154|Device|Femoral Nail PF of the T2 Alpha Femur Antegrade GT/PF Nailing System|The T2 Alpha Femur Antegrade GT / PF Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved.
15853463|NCT04015141|Drug|Perampanel Oral Suspension|Perampanel oral suspension
15853464|NCT04015141|Drug|Perampanel Tablet|Perampanel tablet.
15853465|NCT04015128|Device|Femoral Nail GT of the T2 Alpha Femur Antegrade GT/PF Nailing System|The T2 Alpha Femur Antegrade GT / PF Nailing System is intended for temporary stabilization of bone segments or fragments until bone consolidation has been achieved.
15853466|NCT04015115|Behavioral|Youth Opioid Recovery Support service model|see arm 1 description
15853467|NCT04015089|Dietary Supplement|Partially hydrolyzed formula (pHF)|Infant formula with partially hydrolyzed protein
15853468|NCT04015089|Dietary Supplement|Standard formula (SF)|Infant formula with intact protein
15853469|NCT04015076|Drug|Inzomelid|Active Drug
15853470|NCT04015076|Drug|Placebo|Placebo to Match
15853471|NCT04015063|Other|Anti-Aging Skin Care product|Primary Subjects will use P29429-01 as an anti-aging skin care product on full face twice a day for 12-week.
15853472|NCT04015050|Other|milk based infant formula|Cows milk ased infant formula
15853473|NCT04015037|Combination Product|placebo or drug|Group A and B (medicated or placebo)
15853474|NCT04015024|Drug|SKLB1028 150mg bid|150mg oral administration twice a day
15853475|NCT04015024|Drug|SKLB1028 200mg bid|200mg oral administration twice a day
15853476|NCT04015024|Drug|SKLB1028 300mg qd|300mg oral administration once a day
15853477|NCT04015011|Combination Product|LCD Intervention|composed of approximately 1,080 kcal/day, which includes 3 New Direction Meal Replacements containing 200 kcal (27g protein, 12g carbhydrate, 2g fiber), 1 protein bar containing 160 kcal (5 g protein, 18g carbohydrate, 5g fiber, 2g sugar alcohol), and a 350-calorie controlled meal of protein and vegetables that the patient will make on his/ her own.
15853478|NCT04014998|Other|Virtual Reality|Virtual reality group will have virtual reality for 20 minutes in addition to motor control exercises for 20 minutes. Virtual reality will apply using Oculus Go. On the other hand control group will have only exercise for 40 minutes. Exercises will include same exercises in both groups, but exercise group will perform exercises twice compared to virtual reality group.
15853479|NCT04014985|Other|An extensive biological assessment|To study the morphology of red blood cells, the markers of oxidative stress and the signaling pathway of IFGF1.
15853480|NCT04014959|Combination Product|TMS/ fMRI Stimulation|"The study uses a modified repetitive TMS stimulation protocol. Participants receive active TMS on five separate days: a baseline TMS/ fMRI scan, three mini TMS sessions, and a final TMS/ fMRI scan.
~Again, this level of stimulation is considered to be sub-threshold for that of a TMS treatment protocol."
15853481|NCT04014946|Device|ICD implantation|implantation of the Lumax 540 single/dual chamber ICD or successor
15853482|NCT04014933|Diagnostic Test|LASER SPECKLE FLOWGRAPHY|Non-invasive, real-time imaging and measurement of ocular blood flow of the optic disc and peripapillary region
15853483|NCT04014920|Device|Oxygen group|The control group will receive oxygen (first randomization), HFNO oxygen or standard oxygen (second randomization)
15853484|NCT04014920|Device|NIV Group|The experimental group will receive NIV (first randomization) alternated with HFNO or standard oxygen (second randomization)
15853485|NCT04014907|Procedure|Frozen Elephant Trunk Technique|Endovascular technique forTAA repair
15853486|NCT04014894|Drug|ET019003-T Cells|Fludarabine 25 mg/day on day -5, -4 and -3; Cyclophosphamide 250 or 300 mg/day on day -5, -4 and -3; ET019003-T Cells on day 0.
15853487|NCT04014881|Biological|Third-generation anti-CD123 CAR-T cells|From the minimum dose, If no DLT emerges in the group, then the next group uses the subsequent higher dose. If DLT emerges in a single subject in any dose level, 3 more subjects will be enrolled to the same dose level.
15853488|NCT04014868|Device|Nasal high-flow|See arm description.
15853489|NCT04014868|Other|Sham nasal high-flow|See arm description.
15853490|NCT04014855|Drug|Iron Supplement|in iron deficiency anemia
15853492|NCT04014829|Diagnostic Test|Pain-Pressure Threshold|Performed on bilateral trapezius muscles. Pressure will be applied at 90 degrees downward with an algometer, with the speed of pressure increase approximately 1kgf/s. Upon the sensation of pain, the patient will vocalize or raise her hand to terminate the test, and the highest reading will be recorded (up to maximum 6kgf). If two values are recorded within 0.2kgf of each other, the mean value will be recorded. If two values are greater than 0.2kgf of each other, a third test will be performed and the mean obtained.
15853493|NCT04014829|Diagnostic Test|Mechanical Temporal Summation|"Pinprick hyperalgesia will be evoked using a Von Frey filament, applied to the volar aspect of the dominant forearm. Participants will report using the numerical rating scale the intensity of pain from the first stimulus. Subsequently, ten repetitive stimuli one second apart will be applied with the same filament within an area of 1cm diameter of the same forearm. Subjects will report the rate the pain intensity of the tenth stimulus. The magnitude of MTS is calculated as the difference between the last to the first pain scores. The investigators will classify the participants according to evoked MTS if the last stimulus is rated higher than the first, or no MTS if the last stimulus is rated equal or lower than the first. The research team administering the test will follow a set script."
15853494|NCT04014829|Diagnostic Test|Hospital Anxiety and Depression Scale|Standardized questionnaire to determine the level of anxiety and depression.
15853495|NCT04014829|Diagnostic Test|Pain Catastrophizing Scale|Standardized questionnaire to determine the level of pain catastrophizing.
15853496|NCT04014829|Diagnostic Test|Central Sensitization Inventory|Standardized questionnaire to determine the level of central sensitization.
15853497|NCT04014829|Diagnostic Test|Fear-Avoidance Component Score|Standardized questionnaire to determine the level of fear and avoidance.
15853498|NCT04014829|Diagnostic Test|EQ-5D|Standardized questionnaire to assess generic health-related quality of life.
15853499|NCT04014816|Other|MDR bacteria positivity|A total of 137 patients who received nasogastric tube feeding in an ICU of a tertiary hospital were enrolled.
15853500|NCT04014816|Other|negative fluid balance|A total of 137 patients who received nasogastric tube feeding in an ICU of a tertiary hospital were enrolled.
15853501|NCT04014803|Drug|Dual antiplatelet therapy with a P2Y12 inhibitor plus aspirin|"Dual antiplatelet therapy with a P2Y12 inhibitor plus aspirin will be given according to the allocated arms in patients undergoing elective percutaneous coronary intervention for complex coronary lesion
~Prasugrel plus Aspirin arm
~Clopidogrel plus Aspirin arm"
15853502|NCT04014790|Drug|RGI-2001|Subjects will receive 6 weekly doses of RGI 2001, 100 μg/kg via IV administration after completion of alloHSCT
15853503|NCT04014790|Drug|Standard of Care|Standard of care prophylaxis regimen will be administered according to institutional guidelines
15853504|NCT04014777|Biological|NGM621|NGM621 Dose 1
15853505|NCT04014777|Biological|NGM621|NGM621 Dose 2
15853506|NCT04014777|Biological|NGM621|NGM621 Dose 3
15853507|NCT04014777|Biological|NGM621|NGM621 Dose 4
15853508|NCT04014764|Other|This is a non-interventional study|N/A. This is a non-interventional study. Following consent, the subject will have biospecimen samples taken during routine standard of care procedures, and provided to Sponsor for analysis. Optional research blood draws may occur at treating physician's discretion to obtain additional tissue samples.
15853509|NCT04014751|Other|Symptom Monitoring Intervention|This study involves a cancer care delivery process improvement component where all cohort participants, at specified timepoints, are assessed for psychological distress, pain, fatigue, physical function, practical and supportive needs, and dietary and nutritional needs. Patients with severe elevations in psychological distress, physical symptoms or those who endorse supportive care and/or dietary needs are triaged in real time to appropriate providers within the health system (i.e., social work, nursing pool, nutrition services) to address elevated scores and/or stated needs. As such, within the context of this process improvement care delivery project, real time referrals function as interventional processes within the health system to route patients to relevant points of care based on their needs.
15853510|NCT04014725|Device|Myopia Intelligent Diagnostic System|An artificial intelligence to make diagnosis of myopia using ocular appearance images
15853511|NCT04014712|Drug|Tetrahydrobiopterin|Oral, Single dose
15853512|NCT04014712|Drug|Placebo oral tablet|Single dose
15853513|NCT04014699|Procedure|modified 2.2mm microincision|enlarging the internal incision about 0.4mm for conventional 2.2mm coaxial microincision phacoemulsification
15853514|NCT04014699|Procedure|conventional 2.2mm microincision|conventional 2.2mm coaxial microincision phacoemulsification
15853515|NCT04014686|Other|No exercise intervention group|no exercise intervention
15853516|NCT04014686|Behavioral|Resistance band exercise intervention group|Resistance band exercise training intervention (12 weeks, 3x per week, for 60 minutes per day)
15853517|NCT04014673|Behavioral|Behavioral : Characterization|Behavioral scales and neuropsychological tests; MRI, SPECT/PET
15853518|NCT04014660|Dietary Supplement|Probiotic|The probiotic product consists of two different bacterial strains, L.plantarum Heal 9 and L.paracasei 8700:2
15853519|NCT04014660|Dietary Supplement|Placebo|The placebo supplement consists of corn starch only.
15853520|NCT04014634|Drug|Methylprednisolone|Single GON injection with methylprednisolone
15853521|NCT04014634|Other|Placebo|Single GON-injection with NaCl
15853522|NCT04014621|Device|SPG stimulation|The BrainsGate Ischemic Stroke System (ISS) consists of an implantable neurostimulator designed to deliver electrical stimulation to the sphenopalatine ganglion (SPG) and/or nerves within the greater palatine canal and pterygopalatine fossa.
15853523|NCT04014608|Other|Standard Practice to Prevent Hospital Onset CDI|Bleach cleaning of rooms, use of required soap/water hand hygiene for CDI patients, hand hygiene monitoring, portable ultraviolet (UV) light room disinfection, and monitoring of room cleaning.
15853524|NCT04014595|Procedure|Rotational atherectomy in combination with cutting balloon|Treatment of severely calcified coronary lesion using rotational atherectomy followed by balloon angioplasty using a cutting balloon and Implantation of the hybrid sirolimus-eluting stent.
15853547|NCT04014387|Drug|Suvorexant|Suvorexant (Belsomra) is an FDA approved, dual orexin receptor antagonist. It is prescribed for insomnia, reducing time to sleep onset, and to maintain nighttime sleep.
15853637|NCT04013659|Other|Dental Bleaching with 35% hydrogen peroxide gel + Violet LED Irradiation|After gum protection, the bleaching gel (35% hydrogen peroxide) was applied to the surface of the tooth and irradiated with VIOLET LED
15853525|NCT04014582|Behavioral|Communal Coping Intervention|This intervention aims to foster a shared appraisal and collaboration through: the discussion of past joint coping, education about communal coping (e.g. what it is and why it is beneficial), and discussions to foster the perception of diabetes as shared. Participants in the intervention group will also create collaborative action plans to increase collaboration. Couples in the intervention group will also receive two daily text messages-one a general reminder to engage in communal coping and the other one of the collaborative intentions they created during the in-person session. These couples will also receive a brief diabetes education.
15853526|NCT04014582|Behavioral|Diabetes Education|Couples in the diabetes education group will receive a brief diabetes education and complete individual implementation intentions. Patients will create implementation intentions related to diabetes and partners will create implementation intentions that are not related to health.
15853527|NCT04014569|Device|MPSA Algorithm|Insulin dosing will be adjusted using the MPSA Algorithm
15853528|NCT04014556|Device|micropulse laser|"Micropulse session details:
~Mainster focal grid contact lens (×1.05 laser magnification) was used to perform laser. The 577-nm yellow laser (OcuLight SLx, Iridex Corp., Mountain View, California, USA) was used. Fixed treatment parameters were used in all cases: 200-μm spot size, 200-ms exposure duration, 400-mW power, and a 5% duty cycle. Confluent applications with no spacing were administered using 5x5 grid pattern over the entire edematous area including the fovea."
15853529|NCT04014556|Drug|Aflibercept|Aflibercept
15853530|NCT04014543|Other|gastronomy|"to study the quality of life of caregivers and children with generic questionnaires (13-16), validated and used in other pathologies and chronic diseases of the child.
~This will allow reproducibility and comparisons to other populations, general or other chronic diseases (acute leukemias ...) This is to conduct a pilot study, preliminary to the construction of a larger study, longitudinal with several evaluation times."
15853531|NCT04014530|Drug|Ataluren + Pembrolizumab|Ataluren and Pembrolizumab combination therapy
15853532|NCT04014517|Other|Standard of Care|Standard of Care is represented by the best standard peri-operative treatment already planned for the study population: as for ERAS guidelines, it is represented by fast restoration of liquid and solid diet after surgery (approximately 24 hours after surgery) and pre-operative and post-operative dietary counselling whenever indicated by the surgeon or gastroenterologist
15853533|NCT04014517|Dietary Supplement|Immunonutrition|Impact. Patients will be asked to consume 3 cartons/day of Nestle IMPACT for pre-operative 7 days and 1 carton/day of Nestle IMPACT for post-operative 30 days
15853534|NCT04014504|Diagnostic Test|Neonatal Hearing Screening Test|neonatal hearing screening test results will be evaluated.
15853535|NCT04014491|Procedure|Scapula control exercise|To perform arm elevation in the scapular plane, subjects will be first asked to correct scapular resting posture in sitting with EMG biofeedback. Then the subjects will be instructed to do elevation in the scapular plane, side lying external rotation and dynamic hug plus with control of the scapula by EMG feedback and verbal cues
15853536|NCT04014491|Procedure|scapular strengthening exercise|The subjects in the scapular strengthening group will be asked to perform these three exercises the same as scapula control group and with the same number of trials but without any EMG biofeedback and oral cues of movement or posture correction.
15853537|NCT04014491|Other|No intervention|No intervention
15853538|NCT04014478|Device|Endovascular Denervation|A radiofrequency ablation catheter will be placed in abdominal aorta. At least 6 sites will be ablated with settings of temerature at 60 degree centigrade and time at 120 seconds.
15853539|NCT04014452|Procedure|Microwave ablation|Use of microwave energy to ablate tissue surrounding fetal umbilical cord. All the procedures are performed percutaneously under ultrasound guidance.
15853540|NCT04014452|Procedure|Radiofrequency ablation|Use of radiofrequency energy to ablate tissue surrounding fetal umbilical cord. All the procedures are performed percutaneously under ultrasound guidance.
15853541|NCT04014439|Diagnostic Test|Ratio of Neutrophil to Lymphocyte|Each patient was examined for a blood sample of 6 ml of venous blood taken from the cubital vein using a vacuum tube without anticoagulants. Blood samples were centrifuged at a speed of 3500 rpm for 20 minutes. Samples are processed with abbott® devices, to obtain neutrophil and serum lymphocyte levels. Plasma samples are stored in the refrigerator -20 C. The patient's diaphragm thickness was measured on days 0, 3, 5 and then the measurement was compared. Diaphragm thickness was measured in patients using mechanical ventilation in intensive care rooms.
15853542|NCT04014439|Diagnostic Test|Level of Prealbumin Serum|Each patient was examined for a blood sample of 6 ml of venous blood taken from the cubital vein using a vacuum tube without anticoagulants. Blood samples were centrifuged at a speed of 3500 rpm for 20 minutes. Samples are processed with abbott® devices, to obtain neutrophil and serum lymphocyte levels. Plasma samples are stored in the refrigerator -20 C. The patient's diaphragm thickness was measured on days 0, 3, 5 and then the measurement was compared. Diaphragm thickness was measured in patients using mechanical ventilation in intensive care rooms.
15853543|NCT04014426|Other|Blood sample|"Exposed group:
~15 to 30 minutes before the start of the procedure: 1 EDTA tube of 6 ml for blood (T0)
~2hours after the end of the procedure: 1 EDTA tube of 6 ml (T1)
~Non-exposed group:
~- During the morning (8 to 10 a.m): 1 EDTA tube of 6 ml (T0)"
15853544|NCT04014426|Other|Urinary sample|"Exposed group:
~15 to 30 min before the PIPAC procedure (T0)
~2hours after the end of the procedure (T1)
~The next morning after the procedure (T2)
~Non-exposed group:
~- During the morning (8 to 10 a.m) (T0)"
15853545|NCT04014413|Procedure|Fecal Microbiota Transplantation|Fecal microbiota transplantation
15853546|NCT04014400|Other|Suprathel or Xeroform donor site application|The surgical procedure for recovery of a skin graft will be the same for all patients as follows. Once the patient is taken to the operating room, the selected donor site will be prepared and harvested with a Zimmer Dermatome set at 0.007 to 0.009 thousands of an inch for pediatric patients and 0.12 to 0.14 thousands for adult patients. After the harvesting procedure, the donor site will be covered with Telfa saturated with 1:10,000 epinephrine in normal saline until hemostasis is achieved. The Telfa will be irrigated off the donor site with the epinephrine saline solution. The surgeon will don a new pair of sterile gloves to handle the donor site dressing. The randomized dressing will be applied over the hemostatic donor site with an approximate 1-2cm border. Next, the wound will be dressed with 4x4 cotton gauze pads (fluffs), rolled gauze (Kerlix) and either Coban or BandNet.
15853631|NCT04013698|Other|PEEP level 15 cmH2O|PEEP level set for 45 minutes
15853632|NCT04013685|Biological|TregGraft (Orca-T)|engineered donor allograft
15853548|NCT04014387|Drug|Zolpidem|Zolpidem (Ambien) is an FDA approved, Benzodiazepine Receptor agonist that has been extensively studied for the treatment of insomnia in older adults. It acts as a sedative and is typically prescribed to treat insomnia, reducing time to sleep onset, but may not alter the ability to maintain sleep.
15853549|NCT04014387|Drug|Placebo oral capsule|Placebo (microcrystalline cellulose) capsules will be used.
15853550|NCT04014361|Drug|LY3154885 - Capsule|Administered orally.
15853551|NCT04014361|Drug|Placebo - Capsule|Administered orally.
15853552|NCT04014361|Drug|Itraconazole|Administered orally.
15853553|NCT04014361|Drug|LY3154885 - Tablet|Administered orally.
15853554|NCT04014335|Drug|IONIS-FB-LRx|Participants will receive IONIS-FB-LRx, by subcutaneous injection (SC) at Weeks 1, 3, 5, and every 4 weeks through Week 25.
15853555|NCT04014322|Other|E-cigarette|"All participants will be provided with 8 weeks of e-cigarettes at no cost based on self-report of regular cigarette use.
~All participants will receive a total of 8-10 remote counseling sessions (via phone or video conference) and during which they will discuss ways to switch from smoking cigarettes to exclusively using e-cigarettes, barriers and strategies to overcome them. (All participants will receive sessions at baseline, 2 days, 7 days, 2 weeks, 3 weeks, and 4 weeks, 6 weeks , and 8 weeks after the baseline assessment. Two additional sessions at 5 weeks and 7 weeks (after the baseline assessment) will be provided to those who are still smoking combustible cigarettes at 4-week assessment.)"
15853556|NCT04014309|Other|Supportive and survivorship care program|Provision of routine systematic screening using distress thermometer and problem list with accompanying supportive care nurse service.
15853557|NCT04014309|Other|Usual care|Usual care
15853558|NCT04014296|Behavioral|High Protein Diet|16 week group-based weight loss program with high protein diet. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 32%:40%:28%. Because this protocol uses a sequential, multiple assignment, randomized trial (SMART) design, response will be assessed after 8 weeks. Non-responders will be randomized to either combine the HP diet with supervised resistance training counseling (2 days per week) or add a protein supplement.
15853559|NCT04014296|Behavioral|Resistance Training|16 week weight loss program with normal protein diet and resistance training counseling. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 53%:20%:26%. Because this protocol uses a sequential, multiple assignment, randomized trial (SMART) design, response will be assessed after 8 weeks. Non-responders will be randomized to either combine resistance training with HP/protein supplement or add supervised sessions with a personal trainer (2 days per week) to the resistance training regimen.
15853560|NCT04014283|Dietary Supplement|Selenium supplementation or placebo treatment|Patients from this group will receive selenium supplement to achieve optimal selenium level
15853561|NCT04014283|Other|Diet modification|Patients from this group will have modified diet over the course of the study. Diet modification is aimed to lower selenium concentration in blood.
15853562|NCT04014283|Other|Selenium supplementation or placebo treatment and diet modification|In this group patients will receive supplement, placebo or diet modification. The goal is to raise selenium concentration in blood
15853563|NCT04014270|Device|Self-modulated functional electrical stimulation (SM-FES)|"The patient actively self-administers the electrical stimulation on the impaired limb by controlling the electrical stimulation device with the non-impaired hand. A device called the Intento PRO will be used to deliver the experimental treatment.
~Duration: 90 min per day, 5 days per week, for 2 weeks."
15853564|NCT04014270|Other|Standard Care|"The patient performs intensive, goal-oriented, repetitive functional exercises.
~Duration: 90 min per day, 5 days per week, for 2 weeks."
15853565|NCT04014257|Drug|NOV1601(CHC2014)|a highly selective pan-TRK(tropomyosin receptor kinase) inhibitor targeting tropomyosin receptor kinase A (TRKA), tropomyosin receptor kinase B(TRKB), and tropomyosin receptor kinase C(TRKC)
15853566|NCT04014244|Drug|Corticosteroid vs. Dextrose|US guided injection of corticosteroid in one hand and 5% glucose in the other will be performed in accordance with randomization. In a syringe both substances will be diluted using 0.9% NaCl to a total injection volume of 6 ml. In-plane ulnar approach will be used to visualize the median nerve at the level of the pisiform bone. A standard 23 gauge needle will be inserted in the carpal tunnel with the needle tip positioned between retinaculum and median nerve.
15853567|NCT04014244|Procedure|Corticosteroid or Dextrose vs. Surgery|Injection will be performed unilaterally, after randomization of sides, by the same examiner as in the first part of the study. In all patients included in the second part of the study surgical release will be performed by the same plastic surgeon. The procedure will be performed under local anesthesia, following the same standard protocol. Both treatments will be performed maximally 2 months after diagnosis, with maximum period between them of 1 week.
15853568|NCT04014231|Procedure|Diagnostic Imaging|Undergo placement of single wave application
15853569|NCT04014231|Other|Laboratory Biomarker Analysis|Correlative studies
15853570|NCT04014218|Drug|Inhalation Sedation|Inhalation Sedation by Administration of Sevoflurane
15853571|NCT04014218|Drug|Intravenous Sedation|Intravenous Sedation by Administration of Propofol
15853573|NCT04014192|Drug|Dapagliflozin|Treated with dapagliflozin 10mg/d for one week.
15853574|NCT04014192|Drug|Empagliflozin|Treated with empagliflozin 10mg/d for one week.
15853575|NCT04014192|Drug|Canagliflozin|Treated with canagliflozin 100mg/d for one week.
15853576|NCT04014179|Diagnostic Test|Xpert HCV Viral Load Fingerstick|The Cepheid Xpert HCV Viral Load (VL) Fingerstick assay is an in vitro nucleic acid amplification test designed for the quantitation of Hepatitis C Virus (HCV) DNA in human whole blood using the automated GeneXpert Systems. The HCV RNA result from the Xpert test will be used to initiate HCV treatment.
15853577|NCT04014179|Diagnostic Test|Aptima HCV Quant DX Assay|"The Aptima HCV Quant Dx assay is a real-time transcription-mediated amplification test.
~The assay is used for both detection and quantitation of hepatitis C virus (HCV) RNA in fresh and frozen human serum and plasma from HCV-infected individuals, and in this study from dried blood spots. The HCV RNA result from the Aptima assay will be used to initiate HCV treatment."
15853633|NCT04013672|Drug|Pembrolizumab|200 mg IV every 3 weeks
15853634|NCT04013672|Drug|SurVaxM|500 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
15853635|NCT04013672|Drug|Sargramostim|100 mcg per dose, dosed every two weeks for 4 doses and then every 3 months
15853578|NCT04014166|Other|Human umbilical cord-derived mesenchymal stem cells (hUC-MSCs)|This is a single-arm study to evaluate the safety and efficacy of hUC-MSCs to treat refractory immune thrombocytopenia. The dose of hUC-MSCs will be successively divided into three increasing dose(group A: hUC-MSCs 0.5×10^6/kg, weekly for 4 weeks, 3 patients; group B: hUC-MSCs 1.0×10^6/kg, weekly for 4 weeks, 3 patients; hUC-MSCs 2.0×10^6/kg, weekly for 4 weeks, 3 patients) with 3 patients in each group according to the dose. The principle of increasing dose will be carried out successively from low dose to high dose group. According to the results of the safety and efficacy data from these 9 patients, the investigator will determine one of the doses and expand the sample size to 6 cases.
15853579|NCT04014153|Procedure|Iodinated contrast media|Percutaneous coronary intervention with iodinated contest media
15853580|NCT04014140|Procedure|Coronary artery bypass grafting surgery (CABG)|Patients with MVCAD will undergo CABG as per standard of care.
15853581|NCT04014127|Diagnostic Test|Coronary flow reserve assessment|Coronary flow reserve will be assessed using Doppler transthoracic echocardiograpy and myocardial contrast echocardiography.
15853582|NCT04014127|Diagnostic Test|Sphygmocor|Pulse wave analysis and pulse wave velocity will be assessed using the Sphygmocor device
15853583|NCT04014127|Diagnostic Test|Electrocardiogram|An electrocardiogram will be performed prior to administration of adenosine to ensure no resting conduction disease
15853584|NCT04014127|Other|Blood test|Blood tests will be performed for markers of renal function, bone mineral metabolism and myocardial stretch and injury
15853585|NCT04014127|Other|Urinary albumin/creatinine ratio|Urine will be analysed for albumin/creatinine ratio
15853586|NCT04014114|Other|Digital Genetic Assistant|An end-to-end digital solution to the carrier screening process from participant registration to receipt of the test results and their interpretations. These steps are provided using personalized animated videos.
15853587|NCT04014101|Drug|SHR-1210|SHR-1210 is a humanized anti-PD-1 IgG4 monoclonal antibody
15853588|NCT04014101|Drug|apatinib|Apatinib is a selective VEGFR2 inhibitor.
15853589|NCT04014088|Device|hCPAP vs fCPAP|The patient presented with Acute Cardiogenic Pulmonary Edema will be randomized into either helmet CPAP or facemask CPAP.
15853590|NCT04014075|Drug|Trastuzumab deruxtecan|Antibody component covalently conjugated to a drug component, prepared by dilution based on body weight for intravenous (IV) infusion
15853591|NCT04014062|Combination Product|INTP5|INTP5: A proposed pegfilgrastim biosimilar to US Neulasta.
15853592|NCT04014062|Combination Product|US Neulasta|US Neulasta: FDA-approved pegfilgrastim innovator product.
15853593|NCT04014036|Device|low energy extracorporeal shockwave therapy|Low-intensity extracorporeal shockwave therapy (LI-ESWT) was proved to be useful in various medical conditions; for example, neovascularization in myocardial ischemia, nonhealing wounds, ED and chronic pelvic pain syndrome
15853594|NCT04014023|Drug|DWP16001|DWP16001 tablets
15853595|NCT04014023|Drug|Placebo|DWP16001 placebo-matching tablets
15853596|NCT04014010|Other|Blood pressure|"Systolic Blood Pressure (SBP)
~Maximum change from preoperative SBP, in a) absolute change (mmHg), and b) relative change (%)(emergency and elective cases analyzed separately)
~Cumulative duration (minutes) >=20% below preoperative SBP
~Longest single episode (minutes) below a) 80, b) 90, and c)100 mmHg
~Cumulative duration (minutes) below a) 80, b) 90, and c)100 mmHg
~Mean Arterial Pressure (MAP)
~Maximum change from preoperative MAP, in a) absolute change (mmHg), and b) relative change (%) (emergency and elective cases analyzed separately)
~Cumulative duration (minutes) >=20% below preoperative MAP
~Longest single episode (minutes) below a) 60, b) 65, c) 70, and d) 80mmHg
~Cumulative duration (minutes) below a) 60, b) 65, c) 70, and d) 80mmHg"
15853597|NCT04014010|Other|Heart rate|"Maximum change (beats per minute, BPM) from preoperative heart rate (positive and negative)
~Relative change (%) from preoperative heart rate (positive and negative)
~Maximum pulse variation (maximum heart rate minus minimum heart rate)
~Longest single episode (minutes) a) below 60, and b) above 100BPM
~Cumulative duration (minutes) a) below 60, and b) above 100BPM"
15853598|NCT04014010|Other|Use of hemodynamic medications (i.e. special medications for blood pressure)|"Vasopressor/inotrope use (yes vs. no): phenylephrine, norepinephrine, epinephrine, vasopressin, dobutamine, or milrinone
~Infusion of any vasopressor/inotropes above (yes vs. no) (identified by unit of weight over time)
~Phenylephrine/ephedrine bolus (yes vs. no) (identified by unit of weight only)
~Vasodilator use (yes vs. no): labetalol, esmolol, nitroglycerin, nitroprusside
~Infusion of any vasodilator above (yes vs. no) (identified by unit of weight over time)"
15853599|NCT04014010|Other|Oxygen saturation by pulse oximetry (SpO2)|"Longest single episode (minutes) below a) 88, and b) 90%
~Cumulative duration (minutes) below a) 88, and b) 90%"
15853600|NCT04014010|Other|End-tidal Carbon dioxide (EtCO2)|"Longest single episode (minutes) a) below 30, and b) above 45mmHg
~Cumulative duration (minutes) a) below 30, and b) above 45mmHg"
15853601|NCT04013997|Device|EksoGT|The intervention group received a minimum of 15 hours of standard of care, including physical and occupational therapy, for acute inpatient rehabilitation per week. After enrolling into the study, participants received locomotor training with the exoskeleton as part of their acute inpatient rehabilitation using the Ekso. Standing and walking with the Ekso started as soon as the clinical team determined it was safe for participants to begin standing, and continued until the participant was discharged from inpatient rehabilitation.
15853602|NCT04013984|Other|Accupuncture|In experimental groups (A), acupuncture will be applied for 30 minutes in each session and will be started from the month prior to onset of ovarian stimulation (two sessions of a weekly), and during the ovarian stimulation cycle (two sessions of a weekly), totally 7 acupuncture sessions will be carried out. Acupuncture will be performed using sterile needle on specific points (CV 3 (Zhongji), CV 4 (Guanyuan), ST 25 (Tianshu), ST 28 (Shuidao), ST 29 (Guilai), and LR 3 (Taichong), BL 23 (Shenshu), BL 32 (Ciliao), GV 20 (Baihui), GV 24 (Shenting), GB 13 (Benshen), ST 36 (Zusanli), SP 6 Sanyinjiao), SP 8, SP 10 and KI 3 (Taixi)). The needles were inserted to a depth of 15-30 mm, depending on the region of the body. No sham acupuncture is considered in the control group for ethical and practical reasons
15853603|NCT04013971|Other|Game without AR|During the AGRF biofeedback game without augmented reality (AR) participants will walk on a split-belt treadmill with a projector-display. Participants will be receiving real-time information or feedback about ongoing gait performance parameters while they are walking. The participants will be exposed to the AGRF biofeedback game without AR for 6 minutes.
15853636|NCT04013672|Drug|Montanide ISA 51|1 ml per dose dosed every two weeks for 4 doses and then every 3 months
15853604|NCT04013971|Other|Game with AR|During the AGRF biofeedback game with augmented reality (AR) participants will walk on a split-belt treadmill with a head-mounted AR display. Participants will be receiving real-time information or feedback about ongoing gait performance parameters while they are walking. The participants will be exposed to the AGRF biofeedback game with AR for 6 minutes.
15853605|NCT04013971|Other|Traditional Biofeedback Interface|"For the traditional non-game biofeedback, the visual display comprises a horizontal line graph with a moveable cursor that represents the current measured value of antero-posterior ground reaction force for the targeted leg. The auditory feedback comprises an audible beep produced every time the cursor entered the target range. Participants will be exposed to the traditional biofeedback interface for 6 minutes."
15853606|NCT04013958|Drug|IV Ketamine|IV Ketamine 0.1 mg/kg with IV morphine -0.1 mg/kg with IM Sailne 0.9%
15853607|NCT04013958|Drug|IM Ketamine|IM Ketamine 0.3 mg/kg with IV morphine -0.1 mg/kg
15853608|NCT04013945|Dietary Supplement|Superba Boost (Active)|To assess changes in Trans-epidermal water loss (TEWL), measured at baseline and after 12 weeks of daily consumption with Superba Boost.
15853609|NCT04013945|Dietary Supplement|Vegetable oil (Placebo)|To assess changes in Trans-epidermal water loss (TEWL), measured at baseline and after 12 weeks of daily consumption with Placebo.
15853610|NCT04013932|Behavioral|KUPAA Intervention Group (Culturally Tailored Family Psychoeducation)|"KUPAA is composed of 3 key components:
~1-2 Joining sessions [~30 to 45 minutes each] give the facilitator and participants a chance to get to know each other before KUPAA groups begin and allows time for questions.
~Educational Workshop is an interactive, one day workshop offering information about biological, psychological and social aspects of mental illness; the nature, effects and side effects of psychiatric treatments; what families can do to help recovery and prevent relapse; and guidelines for managing mental illnesses.
~12 Family psychoeducation group sessions [~1.5 hours each session] occur weekly in multi-family groups. These sessions follow an empirically tested format and focus on solving problems that interfere with treatment, illness, and symptoms management and that support coping skills and personal care. Case management may also be provided."
15853611|NCT04013919|Drug|Multiple Daily Injections of Insulin|Basal/ Bolus insulin injections
15853612|NCT04013919|Drug|Single insulin injections|Basal insulin injections only
15853613|NCT04013906|Diagnostic Test|Rotational atherectomy|Rotational atherectomy
15853614|NCT04013880|Drug|CDA Inhibitor E7727/Decitabine Combination Agent ASTX727|Given by mouth
15853615|NCT04013880|Drug|IDH-1 Inhibitor FT-2102|Given by mouth
15853616|NCT04013854|Drug|nivolumab|All arms will receive a pre-surgery dose of nivolumab (480 mg IV). Post-surgery nivolumab doses will be determined by pathologic response and randomization.
15853617|NCT04013854|Drug|Ipilimumab|Only subjects who fail to achieve a complete, or near complete, pathological response, and are then randomized to Arm C will receive Ipilimumab (1 mg/kg) )
15853618|NCT04013841|Other|Oral-agents/Enema|"Oral-agents for mechanical bowel preparation prior to left-side colorectal resection
~Enema for mechanical bowel preparation prior to left-side colorectal resection"
15853619|NCT04013815|Procedure|erector spinae plane block with ropivacaine|The block is performed immediately before surgery. by an ultrasound guide, with the probe positioned longitudinally, the spinous process of T5 is identified. A peripheral block needle is inserted in the cephalo-caudal direction (caliber 21G and length 10 cm) and 3 ml of physiological solution are injected to confirm the injection site: fascial plane between the erector spinae muscle and the large rhomboid, near the tip of the transverse process of T5. Once the correct position of the needle tip has been confirmed, ropivacaine 0.75% 20 ml is injected.
15853620|NCT04013815|Procedure|Intercostal nerve block with ropivacaine|The intercostal nerve block will be performed by the surgeon at the time of thoracotomy from the 4th to the 8th intercostal space, by injecting 20 ml of 0.75% ropivacaine (4 ml for each space). The injection is performed at about 2-3 cm from the spine.
15853621|NCT04013802|Biological|HLA-matched VSTs|"An alternative approach that bypasses the need to grow VSTs for individual patients is to bank closely HLA-matched allogeneic VSTs that could be available as an off the shelf product.
~The HLA-matched VST product is to produce immune activity to CMV, Adv, BK virus and EBV in all recipients.
~Most recently our group extended this off the shelf approach to five viruses using the T cell product manufactured in 10 days. The VSTs were administered to 38 patients with 45 infections in a phase II clinical trial. A single infusion produced a cumulative complete or partial response rate of 92% overall and the following rates by virus: 100% for BKV (n = 16), 94% for CMV (n = 17), 71% for AdV (n = 7), 100% for EBV (n = 2), and 67% for HHV-6 (human herpesvirus) (n = 3)."
15853622|NCT04013789|Device|DACP FreshTech contact lenses|Nelfilcon A soft contact lenses with a modified lens design
15853623|NCT04013789|Device|DACP contact lenses|Nelfilcon A soft contact lenses
15853624|NCT04013776|Dietary Supplement|Phosphate supplemented diet|Participants will be asked to follow a 5 day menu of 750 mg of phosphorus daily along with a daily sodium phosphorus supplement of 500 mg
15853625|NCT04013763|Other|wheat containing skin care products|stop or continue using wheat containing skin care products
15853626|NCT04013750|Other|Modified Constraint Induced Movement Therapy|constraint-induced movement therapy (CIMT) is characterized by the restraint of the less effected upper limb accompanied by the shaping and repetitive task-oriented training of more affected upper extremity.
15853627|NCT04013737|Device|EPIC IMPOC|Clinical Decision Support System for antibiotic prescribing.
15853628|NCT04013724|Behavioral|Group tobacco cessation interventions|"Group Session Week 1 Participants were introduced to the specific components of the group behavioral intervention. Participants shared their expectations and experiences in their goal of tobacco cessation.
~Group Sessions Weeks 2-11 Participants set their anticipated quit date on the 2nd week. During weeks 2 through 11, before the start of the session, feelings of participants were explored, the previous week's self-reported tobacco consumption or cessation attempt was recorded. The topic of each week was explored first by lecture to explain the topic, and then group members took turns sharing their experiences on the topic.
~Group Sessions Weeks 14-26 Behavioral group sessions weeks 14-26 were conducted once a month. Each session began with a round of discussion on how participants were feeling about their cessation attempts, including any challenges they had experienced. The self-reported amount of tobacco used and quit attempts were documented."
15853629|NCT04013711|Diagnostic Test|Thermography|Thermograms will be acquired of both treated and non-treated cancer site for comparison.
15853630|NCT04013698|Other|PEEP level 5 cmH2O|PEEP level set for 45 minutes
15853638|NCT04013646|Drug|Umbilical cord blood infusion|The umbilical cord blood is donated umbilical cord blood which is stored in the cord blood bank donated by Cha Hospital. The total number of nuclear cells should be at least 2 x 10 7 / kg, and at least three out of six of the six human leukocyte antigens (HLA-A, B, DR) should be selected. The cord blood that matches ABO and Rh blood type is preferentially used. Umbilical cord blood infusion is administered intravenously and is performed at the stem cell clinical trial center. The procedure is performed by the doctor who is enrolled in this study. Monitor pulse and oxygen saturation during the procedure.
15853639|NCT04013646|Drug|Erythropoietin injection|Recombinant human erythropoietin is used and is administered intravenously at a maximum of 5 times at a rate of 500 IU / kg 2 times/week after cord blood peripheral blood infusion, calculated as the dose per body weight. Or subcutaneous administration if intravenous administration is not possible. Store in a sealed container at 2-8 °C in the refrigerator before dosing. Erythropoietin injection is performed at the stem cell clinical trial center. The procedure is performed by the doctor who is enrolled in this study. Monitor pulse and oxygen saturation during the procedure.
15853640|NCT04013646|Drug|Placebo umbilical cord blood infusion|Placebo umbilical cord blood infusion is administered intravenously and is performed at the stem cell clinical trial center. The procedure is performed by the doctor who is enrolled in this study. Monitor pulse and oxygen saturation during the procedure.
15853641|NCT04013646|Drug|Placebo erythropoietin injection|Placebo erythropoietin injection is performed at the stem cell clinical trial center. The procedure is performed by the doctor who is enrolled in this study. Monitor pulse and oxygen saturation during the procedure.
15853642|NCT04013646|Procedure|Active rehabilitation|Physical therapy and occupational therapy are performed daily.
15853643|NCT04013633|Other|Lifesaver virtual reality training|CPR training using the Lifesaver virtual reality application
15853644|NCT04013633|Other|Face-to-face training|Short face-to-face CPR training
15853645|NCT04013620|Drug|Belatacept 250 Milligram Intravenous Powder for Solution|"Phase 1 (from 3 to 12 months post transplantation): conversion to belatacept (IV, 5mg/Kg days 1, 15 and 30 then every months) and CNI withdrawal.
~Phase 2 (from 12 to 18 months post transplantation) : belatacept arrest and CNI resumption (tacrolimus target 6 ng/ml)"
15853646|NCT04013607|Dietary Supplement|fructo- and galacto-oligosaccharides|A NDC drink rich in fructo- and galacto-oligosaccharides
15853647|NCT04013594|Dietary Supplement|carbohydrate group|Randomly selected patients of the carbohydrate group are given oral carbohydrate (400ml) 2-3 hours before surgery.
15853648|NCT04013581|Drug|TZD group|Pioglitazone 15mg (Acpio®, once daily, regardless of meal time, for 24 weeks) will be added for T2DM(type 2 diabetes mellitus) patients who had inadequate glycemic control (7% <HbA1c ≤ 10%) with triple therapy (metformin, DPP-4 inhibitors, sulfonylurea). At visit 3 (after 12 week-treatment), patients whose HbA1c level is more than 7.0% will be prescribed increased dosage of pioglitazone : from 15mg to 30mg
15853649|NCT04013581|Drug|SGLT-2 group|Empagliflozin 10mg (Jardiance®, once daily, regardless of meal time, for 24 weeks) will be added for T2DM patients who had inadequate glycemic control (7% <HbA1c ≤ 10%) with triple therapy (metformin, DPP-4 inhibitors, sulfonylurea). At visit 3 (after 12 week-treatment), patients whose HbA1c level is more than 7.0% will be prescribed increased dosage of empagliflozin : from 10mg to 25mg
15853650|NCT04013568|Other|Exercise|"First Intervention 12-week exercise program, 3 days/week, 90min exercise sessions at the Rehabilitation Hospital of the Pacific. Private or semi-private (1:1 or 2:1 ratio participant to instructor) sessions, led by Kinesiology students
~Second Intervention- 12-week exercise program, 2 days/week, 90min exercise sessions at the Rehabilitation Hospital of the Pacific. Group Fitness Classes"
15853651|NCT04013555|Drug|N-acetylcysteine (NAC)|Flavored effervescent formulation
15853652|NCT04013555|Drug|Placebo|Flavored effervescent formulation designed to mimic NAC
15853653|NCT04013555|Drug|Tryptophan|Oral slurry form
15853654|NCT04013542|Biological|Ipilimumab|Given IV
15853655|NCT04013542|Biological|Nivolumab|Given IV
15853656|NCT04013542|Radiation|Radiation Therapy|Undergo radiation therapy
15853659|NCT04013516|Behavioral|Cash Incentive|During the phone call, New Incentives' team member promised a greater cash payment from New Incentives' staff members at primary health care facilities when infants enrolled in the program and received their measles vaccination.
15853660|NCT04013516|Behavioral|Call|A New Incentives' team member reminded caregivers of their child's measles immunization date and the total amount of incentive they would receive once their child was vaccinated. If the caregiver could not be reached on the first attempt, the team made additional attempts at different times of the day on five different days across two weeks (up to 10 attempts were made per caregiver).
15853661|NCT04013490|Dietary Supplement|Cassava dietary fiber capsule|Cassava dietary fiber capsule or placebo will be consumed once daily at the recommended doses of each group.
15853662|NCT04013477|Drug|DA-5207|DA-5207 Transdermal Delivery System
15853663|NCT04013477|Drug|Donepezil Hydrochloride|donepezil HCl 10mg QD
15853664|NCT04013464|Drug|Escitalopram|Escitalopram 10-20mg/d
15853665|NCT04013451|Behavioral|Acts of kindness|Both intervention and control groups will receive an email with access to a relaxation and stress management booklet from Western University's (UWO) Wellness Education Centre (http://studentexperience.uwo.ca/docs/RelaxationAndStressManagement.pdf). In addition, the intervention group will be asked to (1) complete and log/submit a minimum of three deliberate acts of kindness per day for one month, and (2) join the study-dedicated online site to connect with, support, and share experiences and ideas with each other around acts of kindness.
15853692|NCT04013204|Other|Endothelial function guided therapy|To evaluate the effect of integration of non invasive endothelial function test (EFT) as a routine test in increasing appropriate treatment to reduce cardiovascular risk including prescription of lipid, blood pressure and glucose lowering medications by physicians at the clinic for patients with non-obstructive coronary artery disease (NOCAD) and the effect of introducing EFT as a routine test in reducing clinical endpoint (major adverse cardiovascular events) among patients with non-obstructive coronary artery disease(NOCAD).
15853693|NCT04013191|Drug|Padsevonil|Padsevonil will be administered in predefined dosages.
15853666|NCT04013438|Drug|Strogen|The OCP-LD begins in 2 to 3 days of the last menstrual cycle and then 500 μgr/d GnRH-a will received on day 17 for fourteen days. Then in 2-3 days of the next menstrual cycle, GnRH-a reduced to 200 μgr/d dose. the patients will receive 6 mg oral that will be continued for 14 days and during this time endometrium thickness evaluated by vaginal ultrasonography. If endometrial thickness is estimated ≥7mm, intramuscularly progesterone 100 mg/d will be started. After the onset of progesterone (days 17 to 18 cycles) frozen embryos transferred. Control group receive 6 mg oral estrogen and 100 mg intramuscularly progesterone until 12 week of pregnancy. The levels of maternal estrogen and progesterone was measured at the time of the starting day of progesterone (day 15), the day of embryo transfer, 6 and 12 weeks of pregnancy.
15853667|NCT04013438|Drug|Strogen|The OCP-LD begins in 2 to 3 days of the last menstrual cycle and then 500 μgr/d GnRH-a will received on day 17 for fourteen days. Then in 2-3 days of the next menstrual cycle, GnRH-a reduced to 200 μgr/d dose. the patients will receive 6 mg oral that will be continued for 14 days and during this time endometrium thickness evaluated by vaginal ultrasonography. If endometrial thickness is estimated ≥7mm, intramuscularly progesterone 100 mg/d will be started. After the onset of progesterone (days 17 to 18 cycles) frozen embryos transferred. In patients 35 days after embryo transfer and observation of gestational sac with heart beat (6 weeks of pregnancy) by ultrasound, exogenous estrogen will discontinued while progesterone will remain daily use until twelfth week of pregnancy. The levels of maternal estrogen and progesterone was measured at the time of the starting day of progesterone (day 15), the day of embryo transfer, 6 and 12 weeks of pregnancy.
15853668|NCT04013425|Procedure|Ice Cream Cone Technique|Guided bone regeneration
15853669|NCT04013412|Dietary Supplement|Protein-Calorie Restriction|Four day dietary intervention immediately before surgery of ScandiShake [any of 4 flavors] mixed with almond milk, calculated individually for a total daily volume to achieve 30% caloric restriction and 70% protein restriction, based on body weight and activity level.
15853670|NCT04013399|Device|Continuous Positive Airway Pressure|The device is an auto-adjusting pressure device with an integrated humidifier. Pressure is adjusted based on airway resistance.
15853671|NCT04013386|Drug|Aprepitant and Dexamethasone|Aprepitant capsule 80 mg and Dexamethasone 8 mg IVI
15853672|NCT04013386|Drug|Mirtazapine and Dexamethasone|Mirtazapine tablet 30 mg and Dexamethasone 8 mg IVI
15853673|NCT04013386|Drug|Dexamethasone|Dexamethasone 8 mg IVI
15853674|NCT04013373|Device|SOZO Bioimpedance Spectroscopy Device|Bioimpedance spectroscopy measurements for assessment of fluid status
15853675|NCT04013360|Other|Breath Stacking|The patients will perform the maneuver through successive inspiratory efforts for 20 s. Subsequently, the expiratory branch will be unobstructed to allow expiration. This maneuver will be repeated 5 times in each series, with intervals of 30 seconds between them. The technique will be performed with the trunk inclined 30º in relation to the horizontal plane, in 3 series, with interval of 2 min completing 15 min of therapy.
15853676|NCT04013360|Other|Expiratory Positive Airway Pressure|Patients will perform exhalation of air through a facial mask containing an extrinsic positive expiratory pressure valve with a defined load of 10 cmH2O for 5 min. During the application of the technique the patients will have a trunk inclined 30º and will be stimulated to breathe normally, without effort or deep and fast breaths.
15853677|NCT04013347|Procedure|Rectal Resection|Low Anterior Resection and Abdominoperineal Resection
15853678|NCT04013334|Drug|MTG201|MTG201, 3 x 10E12 vp delivered by intratumoral injection on days 1, 8, 22 and 50
15853679|NCT04013334|Drug|Nivolumab Injection [Opdivo]|Nivolumab 480 mg by IV infusion every 4 weeks
15853680|NCT04013321|Device|SleepScore Max coaching feature|The SleepScore max is a non-contact sleep tracking device. The app has an integrated feedback coaching feature to improve sleep.
15853681|NCT04013321|Behavioral|Online CBTi|Online Cognitive Behavioral Therapy for insomnia is a user guided program to track sleep, receive sleep coaching, and initiate behavioral techniques such as tailored sleep scheduling and sleep hygiene to help improve sleep.
15853682|NCT04013308|Procedure|Iontophoresis with 2% potassium iodide|10 iontophoresis treatments with 2% potassium iodide on the area of thyroid gland; electrodes with tin foil (Amperage:2mA, duration: 30min)
15853683|NCT04013295|Other|Prize-linked savings|"Participants will be eligible for prizes based on the amount by which their account balance goes up in each period (e.g. for every 100 Ksh by which savings increases, participants get an entry into a lottery for monetary rewards where they have a small probability of winning a larger amount, or a larger probability of winning a smaller amount of money). This type of prize-linked savings intervention has been shown to promote savings in other settings.
~Other intervention components may include education materials to explain how the prize-linked savings incentives work and that emphasize the potential benefits of saving money. Participants in the intervention group will be encouraged to have more consideration for their future health and economic status, as this may motivate them to save more money. They will also be encouraged to consider the opportunity and health cost of their expenditures on alcohol and transactional sex and not miss the opportunity to win prizes by saving money."
15853684|NCT04013269|Device|CytoSorb-Therapy|Additional use of Cytosorb-Adsorber in patients with septic shock and need for continuous renal replacement therapy
15853685|NCT04013256|Other|Cigarette Smoke|Cigarette smoke, generated by a smoking machine and aged is used to reproduce exposure to secondhand and thirdhand cigarette smoke.
15853686|NCT04013256|Other|Clean Air and Clean Clothing/Sham exposure|"Clean air, created by high-efficiency particulate air (HEPA) and charcoal filtration and temperature and humidity control.
~Clean cotton clothing."
15853687|NCT04013243|Drug|Magnesium Sulfate|magnesium sulphate 50mg/kg in normal saline 50ml infusion for 10minutes for loading dose followed by 15mg/kg/hr for continuous infusion
15853688|NCT04013243|Drug|Placebo|Normal Saline 50ml infusion for loading dose followed by continuous infusion for same dose of magnesium.
15853689|NCT04013230|Behavioral|Usual care|Visit doctor and nurse at the clinic.
15853690|NCT04013230|Behavioral|Web-COP|Usual care plus group sessions and a web-based treatment program for 12 weeks for the child and parents.
15853691|NCT04013217|Combination Product|Eribulin ORA|Oral eribulin mesylate will be supplied as an aqueous solution and HM30181A-UK
15853694|NCT04013178|Behavioral|Accentuated eccentric loading + electromyostimulation|An innovative training intervention to optimize muscle strength and muscle mass
15853695|NCT04013178|Behavioral|Conventional resistance training|A conventional approach to resistance training
15853696|NCT04013165|Behavioral|Active control|Control group received usual care of the Community Mental Health Service, consisted of case management for high-risk older adults and referral to psychiatric services.
15853697|NCT04013165|Behavioral|Village-based intervention|"Individual-based case management was conducted both by healthy community dwellers (local committee) and Community Mental Health Service (CMHS) team based on risk-stratification for depression in older adults. Local committee-guided care was performed after matching a healthy dweller with 4-5 older neighbors included in risk groups. They visited the matched older individuals as often as possible at least once a week using a mood sticker. The CMHS team also conducted a separate case management for older adults with risk-stratified protocols; the higher the risk of suicide, the more intensive was the management, which could include frequent face-to-face visits. High-risk individuals were also referred to the psychiatric service, if deemed necessary.
~Group-based program was comprised of weekly eight sessions, which were mainly consisted of programs enhancing interpersonal network and group cohesion, and were open to all community-dwelling older adults."
15853698|NCT04013152|Other|Clinical database|Constitution of a prospective, multicenter clinical database of surgery with robotic assistance in colorectal pathologies
15853699|NCT04013139|Diagnostic Test|CPET|CPET
15853700|NCT04013126|Diagnostic Test|• Endothelial function using ENDOPAT system|All of the participants will follow an non-invasive test for endothelial function using ENDOPAT 2000 device before surgery. A consecutive assessment will be held 6 weeks and 2 years post-surgery, using the same method.
15853701|NCT04013113|Drug|Haemoperfusion|"Three sessions of Hemoperfusion, 1 plasma volume/session will be done to the selected patients.
~Hemoperfusion will be done through bile acids and ammonia filters to adsorb bile acids and ammonia respectively.
~Group specific fresh frozen plasma will be transfused to the patient through a peripheral vein catheter to prevent hypotension if required."
15853702|NCT04013113|Drug|Standard Medical Treatment|Standard medical therapy only included as per requirement.nutritional therapy ( high calorie intake- 2400 Kcal/ day) Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded.
15853703|NCT04013113|Other|Plasma Exchange|"Fresh frozen plasma will be used as replacement fluid.TPE treatment shall be given on first day and continued on an a dailybasis/alternate day till the desired clinical or biochemical response is achieved.
~The procedures of TPE and hemoperfusion will be stopped if any major side effects occur (described below), the patient expires or the patient is transplanted within 30 days (whichever is earlier)."
15853704|NCT04013100|Diagnostic Test|3D-VNE (virtual neck exploration)|The 3D-VNE model is obtained with VP Planning software (Visible Patient, Strasbourg, France), using DICOM (Digital Imaging and Communications in Medicine) images of contrasted Computed Tomography scan of the neck in operative positioning.
15853705|NCT04013087|Dietary Supplement|Oral feeding of Feihe Stage 1 infant formula|Oral feeding of Feihe Stage 1 infant formula for 16 weeks
15853706|NCT04013087|Dietary Supplement|Oral feeding of control Stage 1 formula|Oral feeding of control Stage 1 formula for 16 weeks (A commercially available product with comparable composition but does not contain sn-2 palmitate enriched vegetable oil as an ingredient (regular vegetable oil is used))
15853707|NCT04013087|Dietary Supplement|Breast feeding|Breast feeding of human milk for 16 weeks
15853708|NCT04013074|Procedure|Transjugular Intrahepatic Portosystemic Shunt|Transjugular Intrahepatic Portosystemic Shunt
15853709|NCT04013074|Other|Standard Medical Treatment|Standard Medical Therapy only included as per requirement nutritional therapy (high calorie intake- 2400 Kcal/ day) as and when required LVP and albumin infusion and diuretics.
15853710|NCT04013061|Other|Pluridisciplinary consultation|Pharmacist-anesthesiologist team will be present during the anesthetic consultation
15853711|NCT04013048|Drug|[14C]-Fluzoparib|Patients will receive single dose of orally [14C]- Fluzoparib on Day 1.
15853712|NCT04013035|Procedure|cervical length measurement|cervical length measurement at second trimester pregnancy termination in nulliparous pregnant women.
15853713|NCT04013022|Behavioral|Exercise History|The groups will be divided based on their exercise history
15853716|NCT04012983|Diagnostic Test|gingival crevicular fluid level|gingival crevicular fluid collection
15853717|NCT04012970|Other|Manual spinal mobilisations|
15853718|NCT04012957|Drug|Desidustat Oral Tablet|Desidustat tablet
15853719|NCT04012957|Drug|Darbepoetin Alfa|Darbepoetin injection
15853720|NCT04012944|Device|Cordella™ Pulmonary Artery Sensor System|"The Cordella PA Sensor System comprises seven subsystems that operate together to take daily Pulmonary Artery Pressure (PAP) readings at a patient's home and transmit the results to a care provider for evaluation.
~Cordella Sensor
~Cordella Delivery System
~myCordella Patient Reader
~Reader Dock
~Cordella Calibration Equipment (CalEQ)
~myCordella Hub
~Cordella Data Analysis Platform (CDAP)."
15853723|NCT04012918|Drug|Capecitabine plus aromatase inhibitor|Capecitabine 625 mg/m2 bid PO for 14 days to be repeated every 21 days until progression in combination with aromatase inhibitor if postmenopausal, addition of LHRH agonist will be added if premenopausal.
15853724|NCT04012918|Drug|A.I.|aromatase inhibitors ( letrozole 2.5 mg PO per day or Anastrozole 1 mg PO per day or aromasin 25 mg PO per day) if post-menopausal, if premenopausal leutnising hormone releasing hormone (LHRH) agonist will be added to the aromatase inhibitor
15853785|NCT04012359|Diagnostic Test|Lung ultrasound|Non-invasive external ultrasonography of the chest wall
15853725|NCT04012905|Drug|Corticosteroids for Systemic Use|"Corticosteroids tapering over 28 weeks:
~J0 = 0,7 mg/kg S2 = 0,6 mg/kg S4 = 0,5 mg/kg S6 = 0,4 mg/kg S8 = 0,3 mg/kg S10 = 0,25 mg/kg S12 = 0,2 mg/kg S14 = 0,15 mg/kg S16 = 0,15 mg/kg S20 = 0,1 mg/kg S24 = 0,05 mg/kg S28 = 0 mg/kg
~Corticosteroids tapering over 52 weeks:
~J0 = 0,7 mg/kg S2 = 0,6 mg/kg S4 = 0,6 mg/kg S6 = 0,5 mg/kg S8 = 0,4 mg/kg S10 = 0,3 mg/kg S12 = 0,25 mg/kg S14 = 0,2 mg/kg S16 = 0,175 mg/kg S20 = 0,15 mg/kg S24 = 0,125 mg/kg S28 = 0,01 mg/kg S32 to S52: - 1mg per month"
15853726|NCT04012892|Combination Product|CD19 CART|CD19 CART
15853727|NCT04012879|Combination Product|CD19 CART|CD19 CART
15853728|NCT04012866|Behavioral|Aerobic exercise training|The aerobic exercise program using progressive resistive stationary bicycle training which will contain warm-up, resistive physical exercise, and cool-down. The training resistance will increase with improvement of participants' performance.
15853729|NCT04012866|Behavioral|Computerized cognitive training|The computerized cognitive training program will be implemented with the brainHQ to target abilities of visuospatial processing, attention, memory, and executive function. The level of the training program will become more difficult with progress in participants' targeted cognitive abilities.
15853730|NCT04012866|Behavioral|Control training|The Control training will receive an intervention including combinations of non-aerobic physical activities and unstructured mental activities.
15853731|NCT04012853|Device|transcranial direct current stimulation|Treatment group will receive 20 minutes of tDCS stimulation at 2.0 mA administered daily for five days per week and a total of 4 weeks. During the 20minute treatment session, both treatment and sham groups will complete mindfulness meditation via VA health system approved program (Mindfulness Coach).
15853732|NCT04012827|Drug|Apatinib Mesylate, doxorubicin, ifosfamide|Doxorubicin 50mg/m2 d1 , Ifosfamide 2.5g/m2 d1-3 , Apatinib mesylate 375mg qd
15853733|NCT04012814|Device|Venus Bliss|The FDA cleared device (Venus Bliss™) is a non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060 nm diode laser applicators (60 mm x 60 mm). A belt is included to allow the operator to secure the laser applicators on the lipolysis treatment area, allowing hands free operation. The device uses vacuum assisted radiofrequency (RF) and PEMF (pulsed electromagnetic field) technology which has been shown in clinical studies to be safe and effective in body circumferential reduction and skin tightening.
15853734|NCT04012801|Diagnostic Test|C13 breath test|C13 breath test for patients of acute myocardial infarction who need dual- antiplatelet after PCI.
15853735|NCT04012788|Dietary Supplement|Synbiotic mixture|A synbiotic mixture consisting of four probiotic strains and inulin (a prebiotic)
15853736|NCT04012788|Other|Placebo comparator|Placebo powder
15853737|NCT04012775|Biological|Insulin Humulin® NPH|4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses
15853738|NCT04012775|Biological|Insulin Rinsulin® NPH|4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses
15853739|NCT04012762|Device|Whole body vibration training|Intermittent whole-body vibration exposure is a training method providing physical stimulation effect on skeletal muscles by increasing gravitational acceleration on the vibration platform.
15853740|NCT04012749|Behavioral|Advance directive|Patient receives a health system-specific advance directive along with a message crafted with input from a broad group of stakeholders at the clinical sites and external advisors. Messaging introduces advance care planning, the purpose of the advance directive and contains instructions for completing it and turning it in, as well as a prompt to discuss the document with the patient's primary care physician.
15853741|NCT04012749|Behavioral|Prepare|Patient invited to use the Prepare For Your Care website (www.prepareforyourcare.org) that will introduce and facilitate advance care planning and guide completion of an advance directive.
15853742|NCT04012749|Behavioral|Facilitator|Facilitator engages patient to activate advance care planning and to carry out navigation and facilitation aspects of advance care planning. Facilitator can tee up advance care planning activities with the primary care physician.
15853743|NCT04012723|Device|MY01 Continuous Compartmental Pressure Monitor|The MY01 Continuous Compartmental Pressure Monitor is intended for real-time and continuous measurement of compartmental pressures.
15853744|NCT04012710|Procedure|Laparoscopy|Conventional abdominal laparoscopy
15853745|NCT04012710|Procedure|vNOTES|Transvaginal natural orifice transluminal endoscopic surgery for salpingo-oophorectomy
15853746|NCT04012697|Behavioral|Peer Support|Participants randomized to the intervention group will be seen by the peer support worker during their stay in the emergency department. The goal of the peer support worker's practice is to address the participant's wellness from a holistic point of view that includes their relationships, connections to the community, general well-being, and sense of empowerment, with an overall focus on quality-of-life goals (Sunderland et al., 2013). The peer support worker will provide a multi-faceted intervention, which aims to foster a peer-to-peer relationship encompassing elements of empathic communication, brief supportive counseling, advocacy for non-medical needs in hospital, liaising and collaborating with medical and nursing staff, motivational interviewing, and connection with programs in the community.
15853747|NCT04012684|Device|Transcranial magnetic stimulation|For one-session rTMS, 50 trains of stimulation are given. Each train is consisted of 4-second 10 Hz, 100% resting motor threshold TMS pulses. The inter-train interval is 26 seconds.
15853748|NCT04012684|Device|Sham|For one-session sham stimulation, 50 trains of stimulation are given. Each train is consisted of 4-second 10 Hz sham pulses. The inter-train interval is 26 seconds.
15853749|NCT04012658|Other|No intervention|No intervention
15853750|NCT04012645|Procedure|application of near infrared-indocyanine green imaging system|Underwent laparoscopic TME and colon-rectum or colon-anal anastomosis. near infrared-indocyanine green imaging system was used to evaluate the anastomotic flood perfusion during the operation; The operator may decide whether to change the surgical programme based on the outcome of the evaluation.
15853751|NCT04012645|Procedure|Non-application of near infrared-indocyanine green imaging system|Underwent laparoscopic TME operation, and the operator judged anastomotic blood supply with naked eyes and performed the surgical intervention based on the experience
15853752|NCT04012632|Other|this study was an observational study and no interventions were given to the participants|the participants were recruited and the data as well as blood sample were collected.
15853753|NCT04012619|Drug|Anlotinib Hydrochloride|Patients receive pemetrexed with cisplatin/carboplatin once every 3 weeks, and anlotinib (dose escalation) once daily on days 1-14.
15853754|NCT04012606|Drug|TORIPALIMAB INJECTION(JS001 ) Carboplatin Cisplatin Etoposide Placebo|TORIPALIMAB INJECTION(JS001 ) or Placebo combined with chemotherapy, 240mg/6ml/vial, Q3W,up to 2 years of treatment.
15853755|NCT04012593|Behavioral|Diary|
15853756|NCT04012580|Behavioral|Therapist-assisted ICBT|An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants. In addition to the online program, therapists, registered social workers, psychologists or supervised graduate students will provide support by email once a week.
15853757|NCT04012567|Device|Investigational device: Biosure Regenesorb Interference Screw|The Biosure Regenesorb Interference Screw, an absorbable screw designed with an open structure and made of biocomposite material made of PLGA, β-TCP and calcium sulfate, is used to fix ligaments, tendons, soft tissues or bone-tendon-bone grafts in knee surgery. Its open structural design enables rapid bone ingrowth to make the screw integrated with bone tissues so as to promote healing.
15853758|NCT04012567|Device|Control device: BIOSURE HA Interference Screw|BIOSURE HA Interference Screws and Drivers are designed for durability and reduced screw breakage. Both the screws and driver have been enhanced to allow screws to fully seat on the driver all the way to the tip of the screw, helping stress distribution and force transfer. The screw design also incorporates a consistent wall thickness throughout the length of the screw for added durability and features a tapered body for ideal ease of insertion.
15853759|NCT04012554|Procedure|avoid chest drainage tube placement after video-assisted thoracoscopic wedge resection of lung|Avoiding chest drainage tube placement after VATS of the lung in the experiment group.
15853760|NCT04012554|Procedure|Indewlling chest drainage tube after video-assisted thoracoscopic wedge resection of lung|Indewlling chest drainage tube after VATS of lung in the control group.
15853761|NCT04012541|Procedure|active dental procedure|scaling and root planing
15853762|NCT04012541|Drug|post-myocardial infarction management|aspirin, clopidogrel, ticagrelor
15853763|NCT04012541|Radiation|basic periodontal examinations|panorama radiograph : full mouth periapical radiograph
15853764|NCT04012528|Other|ERAS program|ERAS program
15853765|NCT04012515|Device|Electrode Pads|Participants wear six electrode pads in total; three different types of pad, worn in the same positions on both sides of the face. The pads on the left-hand side of the face are replaced daily, and those on the right-hand side are replaced every other day. The pads do not administer a medical treatment or perform any other active function. The purpose of the intervention is to determine which combination of pad and replacement regime maximises the tolerability of wear over a 30-day period.
15853766|NCT04012502|Other|Toxicities reduced treatment|Two cycles docetaxel+cisplatin (TP) induction chemotherapy followed by reducing radiation dose(60Gy/30Fx) and omitting concurrent cisplatin chemotherapy when responses to induction chemotherapy are ≥ 50% Partial Response(PR)
15853767|NCT04012502|Other|conventional treatment|Two cycles docetaxel+cisplatin (TP) induction chemotherapy followed by concurrent cisplatin chemoradiotherapy with standard radiation dose (70Gy/35Fx) when responses to induction chemotherapy are less than 50% Partial Response(PR)
15853768|NCT04012489|Procedure|Breath Stacking|Patients were connected to a unidirectional valve coupled to artificial airway (tracheostomy), with bacteriological filter. The ventilator was coupled to the unidirectional valve to measure inspiratory volume mobilized in each cycle and a connection to adapt a manometer. The patient performed successive inspirations for a maximum period of 30 seconds or until unidirectional valve opening or volume increase was observed for 2 consecutive efforts. Ten cycles of the technique were performed, with an interval of 30 seconds.
15853769|NCT04012489|Procedure|Air Stacking|The same system of monitoring and adaptation of the ventilometer and manometer was carried out. A manual resuscitator coupled to a unidirectional valve was used, both connected to the tracheostomy, with a filter interface. Slow and successive inspirations were performed through slow compression of the resuscitator until the maximum inspiratory pressure reached 40 cmH2O. Ten cycles of the technique were performed, with an interval of 30 seconds.
15853770|NCT04012476|Drug|Indocyanine Green|Administration of 5 mg of intravenous indocyanine green after total thyroidectomy for measurement of parathyroid fluorescence under infrared light
15853771|NCT04012450|Procedure|Epidural anesthesia|Performing an epidural anesthesia
15853772|NCT04012450|Procedure|spina-epidural anesthesia|Performing a spina-epidural anesthesia
15853773|NCT04012437|Device|Sphincter Control Training (SCT)|The SCT + device consists of 8 different exercises and an educational session into a app using a masturbation electronic aid device
15853774|NCT04012437|Behavioral|Sphincter Control Training (SCT)|The SCT consists of 4 different exercises and an educational session into a app using a masturbation electronic aid device
15853775|NCT04012424|Drug|curcumin group:Curcumin is an ancient coloring spice . Interestingly, it has various pharmacological activities including analgesic, anti-inf|"effect of taking 400mg curcumin one hour before endodontic ttt on post endodontic pain immediatelly and after 8,12,24,48 hours after endodontic treatment.Curcumin is an ancient coloring spice of Asia which is powerful antioxidant , it has hepatoprotective effect and traditionally used for many remedies . Interestingly, it has various pharmacological activities including analgesic, anti-inflammatory , It is even reported to have antimicrobial effect .
~Medical clinical trials reported on the analgesic effect of curcuminoids in reducing postsurgical pain osteoarthritis and rheumatoid arthritis .
~other name : curcum, tumeric"
15853776|NCT04012424|Dietary Supplement|400mg starch|patints taking(400mg) starch in tabelts in same shape and color of control group before endodontic treatment by one hour and post endodontic pain immediately and after 8,12,24,48 hours after treatment completion
15853777|NCT04012411|Procedure|Brain MRI|Multimodal brain MRI: volumetry, diffusion tensor, functional rest MRI
15853778|NCT04012411|Procedure|Lumbar Punction|Analysis of BDNF, Tau, NFL and TrkB in cerebrospinal fluid
15853779|NCT04012411|Genetic|Blood sample|Analysis of BDNF, Tau, NFL, and Val66Met polymorphism
15853780|NCT04012411|Other|Cognitive evaluation|Symbol Digit Modality Test (SDMT), Stroop test, Trail Making Test, Empan
15853781|NCT04012398|Diagnostic Test|Amsterdam IADL Questionnaire short, German version|Questionnaire to assess impairments in instrumental activities of daily living
15853782|NCT04012385|Behavioral|lifestyle counseling|Nutritional plan and Physical activity goals
15853783|NCT04012372|Other|ROSA Water|Ad libitum hydration with ROSA oligomineral water
15853784|NCT04012372|Other|Control water|Ad libitum hydration with other waters
15853787|NCT04012359|Diagnostic Test|Pulmonary function tests|Pulmonary function evaluation as part of routine care for emphysematous patients
15853788|NCT04012359|Other|Clinical examination|Standard clinical examination performed by investigating physician
15853789|NCT04012346|Device|Transcranial magnetic stimulation|Transcranial magnetic stimulation device will be used. Short protocol iTBS will be applied.
15853790|NCT04012333|Drug|OLIMEL 7,6%E / PeriOLIMEL 2,5%E|OLIMEL 7,6%E will be administered via a central access whereas PeriOLIMEL 2,5%E will be administered peripherally.
15853791|NCT04012320|Other|No intervention, observational study|No intervention, observational study
15853792|NCT04012307|Drug|Candesartan Cilexetil 32mg|Candesartan Cilexetil is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 32 mg of candesartan cilexetil.
15853793|NCT04012307|Drug|Atacand® PROTECT|Atacand® PROTECT is manufactured by AstraZeneca GmbH, Germany. Each tablet contains 32 mg of candesartan cilexetil.
15853794|NCT04012294|Drug|Allopurinol Pill|"Individuals who meet the inclusion criteria and also have morphostructural changes suggestive of MSU crystal deposits in their MSUS will start treatment with allopurinol at a dosage of 150 mg to be taken daily, orally for a month and then to be increased to 300 mg. The rest of the individuals' medication is not to be altered. If a participant presents hypersensitivity to allopurinol, they are to stop the medication and will be excluded from the investigation.
~Three months after starting treatment, the participants will have a physical exam, confirm the continuation of the treatment (adjust dosage if needed) and take a blood sample for laboratory tests. Six months after treatment is started, the participants will be reevaluated by MSUS and have another blood sample taken, Once the study is finished, continuing or ending treatment with allopurinol will be decided by the medical judgment of the physician of each participant."
15853795|NCT04012281|Device|Percutaneous coronary intervention|PCI was performed using 2nd generation DES
15853796|NCT04012268|Device|RIC|Patients allocated to the RIC group will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 50 mmHg over systolic blood pressure for five cycles of 5 min followed by 5 min of relaxation of the cuffs.
15853797|NCT04012268|Drug|Aspirin|patients will accept medication guided by neurologists
15853798|NCT04012255|Drug|Semaglutide (administered by DV3396 pen)|Increasing doses of semaglutide given subcutaneously (sc, under the skin) in the stomach for 21 weeks
15853799|NCT04012255|Drug|Semaglutide (administered by PDS290 pen)|Increasing doses of semaglutide given sc in the stomach for 21 weeks
15853800|NCT04012242|Diagnostic Test|Ultrasound application|Shear wave elastography, shear wave dispersion, attenuation imaging, and intensity analysis
15853801|NCT04012229|Genetic|BRCA mutation|The genetic testing was performed according interregional consensus (Manchester score > or = 16) on blood sample using classical chain-termination (Sanger sequencing) and multiplex ligation-dependant probe amplification to search large rearrangements.
15853802|NCT04012216|Device|Measure of mandibular movement using a mid-sagittal magnetic sensor (Brizzy, Jawac©) Nomics, Liege, Belgium)|A mid-sagittal MM magnetic sensor (Brizzy, Jawac©) Nomics, Liege, Belgium) measures the distance in mm between two parallel, coupled, resonant circuits placed on the forehead and on the chin. Measurements last one night.
15853803|NCT04012216|Device|Gold standard: polysomnography|Polysomnography will be performed according to the American Academy of Sleep Medicine Recommendations 2018
15853808|NCT04012164|Biological|blood sampling|5ml blood sampling
15853809|NCT04012164|Biological|stool collection|self stool collection (2g)
15853810|NCT04012164|Other|Participatory activity and contact investigation|30 human subjects will self-report daily activities and contacts with selected wild and domesticated animals for five months.
15853811|NCT04012164|Other|Anthropological and historical interviews|Oral interviews on current and past practices and engagements with wild and domesticated animals will be conducted with the 30 human subjects who are recruited to self-report their activities (Participatory activity and contact investigation) and to provide blood and stool samples. Another 30 human subjects will be recruited only to participate in the same type of interviews, addressing past and present activities and relations with wild and domesticated animals.
15853812|NCT04012151|Other|Physical measurement|Parturients of gestational week >= 32 weeks will have their arms and fingers measured to generate the conicity index.
15853813|NCT04012151|Other|Cuff size fitting|Fit on arm cuff and finger cuff as selected by investigators based on the measurement.
15853814|NCT04012138|Drug|Salbutamol|10 mg of salbutamol nebulized in 30 minutes (with oxygen 8 liters per minute or with air) 10 units of regular insulin (rapid-acting, insuline asparte, intravenous injection) as an intravenous bolus with 500 ml of 10% dextrose in water administered over a 30-minute period.
15853815|NCT04012138|Drug|Insulin Aspart|"Patients in the experimental group will receive either:
~10 mg of salbutamol nebulized in 30 minutes (with oxygen 8 liters per minute or with air); OR
~10 units of regular insulin (rapid-acting, insuline asparte, intravenous injection) as an intravenous bolus with 500 ml of 10% dextrose in water administered over a 30-minute period plus 10 mg of salbutamol nebulized in 30 minutes (with oxygen 8 liters per minute or with air). The nurse will start by giving the 10 units of insulin and the dextrose, and then, immediately, she will start the nebulization of salbutamol."
15853816|NCT04012125|Device|flexible thoracolumbar brace|Subjects would wear the flexible thoracolumbar brace over 18 hours a day
15853817|NCT04012112|Device|thoracolumbar brace (Flexpine brace)|Patient's would wear the FLEXpine brace over 18 hours a day for the 6 month
15853818|NCT04012099|Drug|BMT101|Intradermal injection to each of 3 dose-groups.
15853819|NCT04012086|Other|Physical therapy|Our physical therapy program included a variety of different exercise modalities (aerobic exercises, treadmill training and exercise intervention program) performed under the supervision of a physiotherapist
15853820|NCT04012073|Device|Invasive Mechanical ventilation|"Volume-control ventilation with tidal volume will be set at 6 mL/Kg of predicted body weight, respiratory rate to maintain pH>7.30 and PaCO2<50 mmHg and FiO2 will be set to achieve a SpO2>88-95%.
~In case of hypercapnia with Ph<7.30 despite a respiratory rate=30-35, an increase in tidal volume up to 8 ml/kg will be allowed.
~In both groups, the assigned ventilation protocol will be followed for a minimum of 72 hours from randomization and any time fully controlled ventilation is deemed necessary by the attending physician up to 14 days from randomization. After 14 days from randomization, PEEP will be set according to the clinical practice of each institution.
~After 72 hours from the study protocol, the PEEP setting protocol according to the assigned treatment will be resumed at any time within 14 days from enrolment if fully controlled ventilation is established, according to the decision of the attending physician in charge."
15853821|NCT04012073|Drug|Neuromuscular Blocking Agents|All patients will receive NMBA for 48 hours after the enrolment. The decision to stop NMBA administration after 48 hours will be left to the attending physician, but muscle paralysis will be strongly encouraged if PaO2/FiO2 ratio remains lower than 80-100 mmHg. NMBA administration will be resumed anytime deemed necessary by the attending physician.
15853822|NCT04012073|Procedure|Prone positioning|Prone positioning will be used in all enrolled patients as a standard of care: the decision about the timing and the duration of prone position sessions will be left to the attending physician and the time spent by the patient in the prone and in the supine position will be recorded: PEEP will be re-set according to the protocol of the allocated treatment anytime patient's position is changed.
15853823|NCT04012073|Procedure|Resume of spontaneous breathing|"Assist/control and assist ventilation will be allowed after 72 hours from the enrolment if deemed appropriate by the attending physician.
~During spontaneous breathing, PEEP will be set according to the decision of the attending physician and the practice of each institution: however, in order to standardize the treatments, moderate PEEP (10-15 cmH2O) will be encouraged in case of moderate hypoxemia (PaO2/FiO2<150 mmHg) in control group, while PEEP close to the value set during controlled ventilation according to the treatment protocol but <15 cmH2O will be suggested in the intervention group.
~During assist/control and assisted ventilation, PEEP will never be higher than the last PEEP set according to the assigned protocol during controlled ventilation.
~Fully controlled mechanical ventilation will be resumed any time during the study period if the patient meets the criteria described above or any time deemed necessary by the physicians in charge"
15853824|NCT04012073|Procedure|Rescue treatments|Recruitment maneuvers, extracorporeal membrane oxygenation (ECMO), extracorporeal CO2 removal (ECCO2-R) after randomization will be allowed in both groups as rescue therapies and according to the decision of attending physicians: any of these procedures will be accurately recorded on the case report form.
15853825|NCT04012073|Procedure|Weaning from PEEP|"In order not to delay weaning from mechanical ventilation, when a patient is managed with assist/control or assist ventilation with PEEP higher than 8 cmH2O, a daily PEEP weaning trial will be performed whether PaO2/FIO2 ratio>150 mm Hg and FIO2<0.5: PEEP will be decreased to 8-5 cm H2O and arterial blood gas will be sampled after 20 -0 minutes. Previous ventilatory settings will be resumed if during the procedure transcutaneous oxyhemoglobin saturation decreases below 88%, PaO2/FIO2 falls below 150 mm Hg or if the patient experiences abnormal changes in respiratory rate or other clinical signs suggestive of respiratory distress.
~When PaO2/FIO2 is no lower than 200 mm Hg at PEEP≤8 cmH2O, the patient will be considered to have acceptable gas exchange on 8-5 cmH2O of PEEP and will be deemed capable to tolerate this setting"
15853826|NCT04012073|Procedure|Weaning from mechanical ventilation|"A 30-120-minute spontaneous breathing trial will be initiated as the following criteria are met and whether the patient tolerates fully assist ventilation with PEEP≤8 cmH2O for at least 4 hours without experiencing hypoxemia (SpO2<88% or PaO2/FiO2<150mmHg):
~improvement or resolution of the underlying cause of acute respiratory failure
~normal sensorium
~correction of arterial hypoxemia (PaO2 ≥ 60 mmHg at a FiO2 ≤ 0.4 with PEEP ≤ 8 cmH2O);
~absence of fever (≥ 38 °C) or sepsis;
~blood hemoglobin concentration of 7 g/dL or more;
~hemodynamic stability
~For the purpose of the study, success of the spontaneous breathing trial will be defined as presence of the following criteria:
~respiratory rate < 35/min,
~arterial oxygen saturation ≥ 90%,
~heart rate < 120/min,
~systolic blood pressure > 90 and < 160 mmHg
~adequate cough. If the spontaneous breathing trial is successful, the patient will be extubated."
15853827|NCT04012073|Procedure|Extubation|"Each extubated patient will undergo oxygen therapy via high flow nasal cannula (maximum flows tolerated and FiO2 titrated to obtain 96%>SpO2>92%). Pre-emptive noninvasive ventilation (NIV) after extubation will be allowed in prolonged to wean patients (i.e. more than 3 SBT failure or more than 7 days from the first spontaneous breathing trial to being extubated) if deemed necessary by the physician in charge.
~In case of respiratory failure during oxygen therapy via high flow nasal cannula after extubation and, a rescue NIV trial will be allowed before intubation in both groups at the discretion of the attending physician."
15853828|NCT04012060|Procedure|Limited access aortic valve replacement.|Limited access aortic valve replacement through partial upper hemisternotomy
15853829|NCT04012060|Procedure|Conventional aortic valve replacement|Aortic valve replacement through full median sternotomy
15853830|NCT04012047|Drug|Levcromakalim|To investigate the role of levcromakalim compared with placebo in migraine with aura patients
15853831|NCT04012047|Drug|Saline|To investigate the role of levcromakalim compared with placebo in migraine with aura patients
15853832|NCT04012034|Device|Radiofrequency A|Application of radiofrequency for 30 minutes per week during 8 weeks
15853833|NCT04012034|Device|Radiofrequency B|Application of radiofrequency without energy for 30 minutes per week during 8 weeks
15853834|NCT04012021|Diagnostic Test|7T Magnetic Resonance Imaging|"T1-weighted and T2-weighted sequences
~quantitative magnetic resonance imaging approach
~proton spectrum analyses"
15853835|NCT04012008|Other|Comprehensive care|"Regular follow-up by nephrologists every 1-3 month
~Multidisciplinary team consisting pharmacists, nurses, and dieticians"
15853836|NCT04012008|Other|Standard care|"Regular follow-up by internists every 3 month
~May consult nephrologists case-by-case"
15853953|NCT04010955|Drug|Edoxaban Monotherapy|when the patients will be initially registered in this study, duty physicians will make a decision to give additional antiplatelet therapy in addition to standard edoxaban therapy.
15853954|NCT04010942|Drug|Vit D|Injection
15853837|NCT04011995|Behavioral|Intermittent caloric restriction|"The intervention is based on the 5:2 diet, which involves caloric restriction for 2 days (consecutive or nonconsecutive, 600kcal/d for male and 500kcal/d for female) per week and unrestricted eating during the other 5 days of the week.
~Total trial duration is one month consisting of a 14-day intervention phase and a 14-day self-maintenance phase. During the maintenance phase, two follow-up electronic questionnaires were conducted."
15853838|NCT04011995|Behavioral|Low carbohydrate diet|"During the 14-day intervention period, the subjects receive 7 days (consecutive or nonconsecutive) of low carbohydrate diet intervention. Carbohydrate intake of low-carbohydrate diet should be controlled as ≤ 50g per day.
~Total trial duration is one month consisting of a 14-day intervention phase and a 14-day self-maintenance phase. During the maintenance phase, two follow-up electronic questionnaires were conducted."
15853839|NCT04011995|Behavioral|Health education on reducing the cardiometabolic risk|Health education is conducted once a week during 14-day dietary intervention for all subjects. Health education including the understanding of cardiovascular disease, how to determine the cardiometabolic risk level, and the lifestyle intervention as caloric restriction and increased physical activity to promote health.
15853840|NCT04011969|Diagnostic Test|Score assessment|Asia Pacific Colorectal Screening (APCS) is a validated tool to predict the risk of colorectal cancer in asymptomatic Asian population. The scoring system comprises of three categories: low risk (score 0-1), moderate risk (score 2-3) and high risk (score 4-7). Patients with moderate and high risk will undergo further examinations.
15853841|NCT04011969|Diagnostic Test|Blood sampling|"Blood samples will be taken before colonoscopy procedure to evaluate the level of serum CEA by ELISA method and to evaluate the presence of NF-ҡB by immunohistochemical method.
~Carcinoembryonic antigen (CEA) is a well-known marker for colorectal cancer. A pre-treatment serum CEA level of ≥ 5 ng/mL is associated with poor prognosis in colorectal cancer patients.
~NF-ҡB is a chronic inflammation marker found in colorectal cancer patients."
15853842|NCT04011969|Diagnostic Test|Fecal sampling|"Fecal samples will be taken before colonoscopy procedure to be tested for FIT and to evaluate the gut microbiome.
~Fecal immunochemical test (FIT) is a recommended screening method for colorectal cancer. Detection of hemoglobin over a certain level in fecal samples indicated a positive FIT. Patients with positive FIT will undergo further examinations.
~Gut microbiome examination will be conducted with next generation sequencing (NGS) method."
15853843|NCT04011943|Other|Fecal Microbiota Transplantation|Fecal Microbiota Transplantation
15853844|NCT04011930|Drug|cholecalciferol|80,000 IU(2 capsules)/week for 13 weeks and then according to the serum calcium and serum D level 40,000 IU/2 to 3 weeks for next 13 weeks
15853845|NCT04011930|Drug|Placebo oral capsule|80,000 IU(2 capsules)/week for 13 weeks and then according to the serum calcium and serum D level 40,000 IU/2 to 3 weeks for next 13 weeks
15853846|NCT04011917|Behavioral|Standard care|Treatment by an extended scope physiotherapist following Standard Operating Procedures.
15853847|NCT04011904|Other|Cross-over study|Traditional Inuit Diet vs Westernized Diet
15853848|NCT04011891|Procedure|Robotic Partial Nephrectomy|Robotic partial nephrectomy using da Vinci robot.
15853849|NCT04011891|Procedure|Open Partial Nephrectomy|Standard open partial nephrectomy
15853850|NCT04011878|Procedure|Combined trabeculotomy trabeculectomy with mitomycin C|Combined trabeculotomy trabeculectomy with mitomycin C with histopathological examination of the peripheral iris tissue specimen of all cases
15853851|NCT04011865|Procedure|Radical prostatectomy|The patients diagnosed with prostate cancer (local or locally advanced stages) will be allocated to the study for performing radical prostatectomy surgery.
15853852|NCT04011852|Device|Electrical Impedance tomography|Monitoring with Electrical impedance tomography during spontaneous breathing trials on T-piece in children
15853853|NCT04011839|Drug|Levobupivacaïne|Use of Levobupivacaïne instead ropivacaïne
15853854|NCT04011826|Device|Device: Trial nasal mask (F&P)|This trial nasal mask will serve as the participant's primary PAP/BPAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial nasal mask as their primary PAP/BPAP therapy mask for 6 months after Visit 3.
15853855|NCT04011813|Other|Hypotaurine : antioxidant and osmoregulator|"Hypotaurine has protective effects on sperm motility, capacitation and acrosome reaction and reduces apoptotic markers.
~Hypotaurine (50mM) was added in density gradient centrifugation, washing and cryopreservation media washing and cryopreservation media before spermatozoa freezing"
15853856|NCT04011800|Procedure|Catheter ablation|Pulmonary vein isolation, or additional left or right-sided atrial lesions.
15853857|NCT04011800|Combination Product|Risk Factor Modification|dietary restriction, physical exercise, reduced alcohol intake with antiarrhythmic drugs
15853858|NCT04011787|Dietary Supplement|bolus NGT feeding|Participants randomised to bolus NGT feeding will receive this for 7 days at mealtimes
15853859|NCT04011787|Dietary Supplement|Continuous NGT feeding|Participants randomised to bolus NGT feeding will receive this continuously for 7 days as per hospital protocol
15853860|NCT04011787|Diagnostic Test|Continuous Glucose Monitoring|Both participant groups will have continuous glucose monitoring performed for 5 days while in the study
15853861|NCT04011787|Diagnostic Test|Metabolic Profile|Bloods will be taken to assess all patients metabolic profile
15853862|NCT04011787|Radiation|Chest X-ray|A chest X-ray will be performed on patients receiving study interventions on day 7 to confirm/exclude pneumonia
15853863|NCT04011774|Other|PLANI-REV|Cognitive remediation program.
15853864|NCT04011774|Other|RELAXATION|Stimulation with no cognitive remediation.
15853865|NCT04011761|Other|expert arbitration over discordant diagnoses made by AI diagnostic system and human doctors, respectively|Each participant receives two diagnoses: one from the AI diagnostic system and the other from pediatricians, and the two diagnoses are discordant. Participants in the experimental arm will be referred to an expert arbitrator for differential and decisive diagnosis and will receive treatment prescribed by the expert arbitrator.
15853866|NCT04011748|Combination Product|Stem Cell Educator therapy combined with minoxidil|AA subjects will be recruited and initially primed with oral minoxidil for 30 days, and followed by the treatment with SCE therapy.
15853867|NCT04011735|Drug|Respimat|Soft Mist Inhaler product
15853955|NCT04010942|Drug|Metformin|tablets
15853956|NCT04010942|Drug|Clomiphene|Tablet
15855355|NCT03999554|Other|Placebo|This group will receive saline placebo administered intranasally.
15853868|NCT04011722|Device|Portico™ NG Valve and FlexNav™ Delivery System|Subjects will undergo transcatheter aortic valve replacement (TAVR) with the new generation Portico NG valve and second-generation FlexNav Delivery system via a transfemoral or alternative access approach according to the site's anesthesia protocol for TAVR procedures.
15853869|NCT04011709|Combination Product|VR647 Inhalation System + VR647 Smart Card 3 Secs|3 attempts of 19 inhalations, 3 second per breath. Attempts 1 and 2 will be made with air only. Attempt 3 will be made with isotonic saline (0.9% NaCl)
15853870|NCT04011709|Combination Product|VR647 Inhalation System + VR647 Smart Card 2 Secs|3 attempts of 28 inhalations, 2 second per breath. Attempts 1 and 2 will be made with air only. Attempt 3 will be made with isotonic saline (0.9% NaCl)
15853871|NCT04011709|Combination Product|VR647 Inhalation System + VR647 Smart Card 4 Secs|3 attempts of 14 inhalations, 4 second per breath. Attempts 1 and 2 will be made with air only. Attempt 3 will be made with isotonic saline (0.9% NaCl)
15853872|NCT04011670|Other|200 mg caffeine tablet|"Transcranial alternating current stimulation (140 Hz tACS) at 1 mA and active vigilance condition
~Transcranial alternating current stimulation (140 Hz tACS) at 1 mA and passive vigilance condition
~Transcranial alternating current stimulation (140 Hz tACS) sham and active vigilance condition
~Transcranial alternating current stimulation (140 Hz tACS) sham and passive vigilance condition"
15853873|NCT04011670|Other|Non-active tablet|"Transcranial alternating current stimulation (140 Hz tACS) at 1 mA and active vigilance condition
~Transcranial alternating current stimulation (140 Hz tACS) at 1 mA and passive vigilance condition
~Transcranial alternating current stimulation (140 Hz tACS) sham and active vigilance condition
~Transcranial alternating current stimulation (140 Hz tACS) sham and passive vigilance condition"
15853874|NCT04011657|Other|Compulsory CDSS|Compulsory CDSS use with prospective review feedback in patients prescribed with piperacillin tazobactam or carbapenems
15853875|NCT04011644|Behavioral|A-CHESS self-monitored|Patients have access to a smart phone app that provides information on tips on how to reduce drinking, a drink tracker, a journal, discussion boards, and private messaging with a research team member. Patients set weekly goals related to their drinking, reassess each week, and set a new goal for the upcoming week.
15853876|NCT04011644|Behavioral|A-CHESS peer-supported|Patients have access to a smart phone app that provides information on tips on how to reduce drinking, a drink tracker, a journal, discussion boards, and private messaging with a counselor. Patients set weekly goals related to their drinking, reassess each week, and set a new goal for the upcoming week.
15853877|NCT04011644|Behavioral|A-CHESS clinically-integrated|Patients have access to a smart phone app that provides information on tips on how to reduce drinking, a drink tracker, a journal, discussion boards, and private messaging with a health coach. Patients set weekly goals related to their drinking, reassess each week, and set a new goal for the upcoming week.
15853878|NCT04011631|Procedure|Internal defibrillation during cardiac surgery, using the iD-system|When ventricular fibrillation of ventricular tachycardia occurs during surgery, the iD-Paddle will be applied directly to the heart. A maximum of 4 shocks are delivered to the heart to restore normal sinus rhythm. If 4 shocks are not successful standard operating procedure will be enable conform hospital protocol.
15853879|NCT04011618|Drug|Ellagic Acid / Pomegranate Extract|Phenolic acid, ellagitannin, found in a wide variety of fruits and nuts; in this particular case, pomegranate extract with ellagic acid 90% 500mg capsules. Homologated to the other intervention. Dosage twice a day orally every 12 hours during 12 weeks
15853880|NCT04011618|Drug|Placebo oral capsule|Calcinated magnesia in 500mg capsules. Homologated to the other intervention. Dosage twice a day orally every 12 hours during 12 weeks
15853881|NCT04011605|Procedure|Biological Sample of Carious Dentin|Dental patient volunteers will have either areas of decayed tooth structure or recurrent caries defective fillings removed using conventional, routine procedures, which will include: local anesthesia; tooth isolation using rubber dam; removal of superficial decay, weakened tooth structure or defective filling materials with rotary tooth cutting instruments; and then removal of softened dentin using sterile sharp spoon excavators, by hand. The limit of dentin removal will be determined by the clinician's estimate of tooth hardness, that is, using present conventional and ethical practice.
15853884|NCT04011579|Other|MSFIT|MSFIT, by using the Microsoft Kinect Motion Controller Xbox to deliver adapted physical activity, offers the possibility to transform the Pilates exercises into a virtual reality game. Each exercise is implemented with different levels of difficulty in order to allow the adaptation to the capacities of the user.
15853885|NCT04011566|Diagnostic Test|ShuntCheck|The intervention is an FDA-cleared device utilizing a transcutaneous thermal convection to analyze shunt flow.
15853886|NCT04011553|Other|Virtual Reality based Rehabilitation Program|"Virtual reality-based rehabilitation was implemented via MarVAJED system. At first the sensors of MarVAJED® were placed under and above the knee joint and then it was calibrated. The content of the game programs included in the MarVAJED system and how to perform these games with the exercises were explained to the participants. We used games called Crazy Wings and Blasting Ball included in the MarVAJED®.There was a bird figure in Crazy Wings game and represented knee joint of participants. Although the bird figure moved upwards during knee flexion, it moved downward in knee extension, there were some obstacles on the way of the bird went. The subjects were asked to follow the bird figure visually and to pass through the obstacles by flexing or extending their knees when they encountered obstacles."
15853887|NCT04011540|Behavioral|Digital data|Receiving digital data prior to a scheduled mental health session
15853888|NCT04011527|Procedure|Rotational Atherectomy in Coronary Lesion/s|
15853889|NCT04011514|Behavioral|Dedicated stroke nurse care in ED|A specialized SU nursing team partner with ED nursing staff for timely fulfillment of stroke quality care indicators while awationg admission to a dedicated stroke unit
15853890|NCT04011501|Procedure|Continuous Erector spinae block|Erector spine block and catheter placement will be performed for continuous analgesia prior to the surgical procedure.A initial bolus of 20 ml of Levobupivacaine 0.25% will be administered. Subsequently a 22G catheter will be introduced. At the end of the surgery, an elastomeric pump will be installed at a flow rate of 7 ml / hr with a 1.3% Ropivacaine solution.
15853957|NCT04010929|Procedure|Partial pulpotomy with laser+MTA|After removing caries, laser+MTA was applied to the exposed area on the pulp following bleeding control with 5.25% NaOCl.
15853891|NCT04011488|Other|Shared Decision Making Tool|"We've used the framework from this model and adapted it to the patient perspective to create a Patient Shared Decision Making Tool. The model is interactive so it can be customized to a specific patient. It has adjustments built in for gender, race/ethnicity, age, and select comorbidities (obesity, hypertension and diabetes).
~The strongest, underlying message is that any treatment choice is better than not seeking treatment. To illustrate this, a Do Nothing pathway is included for comparison purposes."
15853892|NCT04011475|Drug|Tiotropium + Olodaterol|Spiolto®
15853893|NCT04011475|Drug|Other LABA/LAMA|tiotropium/olodaterol, indacaterol/glycopyrronium, vilanterol/umeclidinium
15853894|NCT04011475|Drug|LAMA|aclidinium bromide, glycopyrronium, tiotropium, umeclidinium
15853895|NCT04011462|Device|prewarming 20 minutes|prewarming with a forced air warming system, using a blanket covering the whole body, regulated to the temperature of 38 °C for 20 minutes.
15853896|NCT04011462|Device|prewarming 30 minutes|prewarming with a forced air warming system, using a blanket covering the whole body, regulated to the temperature of 38 °C for 30 minutes.
15853897|NCT04011449|Device|Medtronic RC+S DBS system|Implantation of the Medtronic RC+S Deep Brain Stimulation (DBS) system
15853898|NCT04011436|Other|Strengthening program|"Both protocols lasted eight (8) weeks, the anatomical conditioning phase was carried out in two weeks of intervention, followed by 4 weeks of strengthening or strength increase and two additional weeks as a final or maintenance phase, at the end of which performed the final evaluations to identify if there were differences in the groups after the physiotherapeutic intervention.
~Group A: 28 exercises Group B: 24 exercises"
15853899|NCT04011423|Other|Unstable shoes plus Whole-body vibration|Wearing unstable shoes during the whole-body vibration training
15853900|NCT04011423|Other|Stable shoes plus Whole-body vibration|Wearing stable shoes during the whole-body vibration training
15853901|NCT04011410|Drug|Hydroxychloroquine Sulfate 200Mg Tab|Twice daily for 90-days, administered two weeks prior to radiation/surgery of oligometastatic lesions
15853902|NCT04011397|Other|Exercise intervention|Exercise intervention (reduced-exertion, high-intensity interval training) delivered within an NHS setting. Consisted 10 min of cycle ergometry (inclusive of warm-up and cool down) including very brief maximal cycle sprints.
15853903|NCT04011397|Behavioral|Usual care|Members of a multi-disciplinary team including a consultant, diabetes specialist nurse, clinical psychologist, physiotherapist, and dietician worked together to promote patient self-management. Care was tailored to the specific circumstances of each patient after initial assessment and focussed on weight management, dietary education, behavioural therapy, and supported pharmacotherapy initiation as appropriate.
15853904|NCT04011384|Behavioral|Behavioral economic intervention of online purchasing at a food pantry|This intervention includes multiple behavioral economic interventions, healthy food shopping cart defaults, healthy placement choice architecture, traffic light nutrition labels, social norms messaging, and healthy swaps.
15853905|NCT04011371|Procedure|Cyanoacrylate closure|Cyanoacrylate glue embolization targeting venous insufficiency
15853907|NCT04011345|Dietary Supplement|Folic Acid Supplement|1 milligram folic acid
15853908|NCT04011345|Dietary Supplement|Placebo|Placebo
15853909|NCT04011332|Other|Integrated Care Model|The patients who are hospitalised due to a COPD exacerbation will be aligned to a nurse-led integrated care model for three months. The model constitutes a bundle of interventions that are commonly known as key elements in COPD management. In addition, the ANP-Team (Advanced Nursing Practice-Team) will coordinate the different health professionals within the hospital and across transitions within the three months.
15853910|NCT04011319|Behavioral|group culture|Four embryos were cultured in the same droplet by a special dish.
15853911|NCT04011306|Device|Lumina24 BLU|Lumina24 BLU is the technology used to deliver continuous low-irradiance phototherapy for the treatment of acute burns
15853912|NCT04011293|Biological|CNCT19|0.5 to 4 x 10^6 autologous CNCT19 transduced cells per kg body weight, with a maximum dose of 4 x 10^8 autologous CNCT19 transduced cells via intravenous infusion.
15853913|NCT04011280|Drug|Varenicline|The ten 30-minute sessions will target core processes in ACT such as acceptance and being present.
15853914|NCT04011267|Other|Physical therapy by foot-ankle segmental and functional exercises|The physiotherapeutic foot-ankle exercise protocol is based on previous clinical trials. It was designed following three criteria established in a supervised, face-to-face intervention: muscle stretching; strengthening of the intrinsic muscles; and strengthening of the extrinsic foot-ankle muscles and functional exercises, such as balance and gait training. To avoid monotony, game principles were inserted to reward the exercise execution and enhance motivation. The exercises change from session to session, and the maximum duration is no longer than 20 minutes. The exercises should only be done 3 times/week; no more than eight exercises each day; and the individual difficulty is regulated by the effort scale to manage the customized progression. In total, 39 different exercises were chosen, and when including their sublevels of progression, a total of 104 different exercises can be completed.
15853915|NCT04011254|Procedure|haemodialysis|Routine haemodialysis session
15853916|NCT04011241|Drug|BI 1323495|Tablet
15853917|NCT04011241|Drug|Itraconazole|Oral solution
15853918|NCT04011228|Diagnostic Test|Blood sampling|After a fasting period over night blood samples will be taken.
15853919|NCT04011228|Diagnostic Test|Saliva and blood samples|After a fasting period over night blood and saliva samples will be taken for the investigation of epigenetics based modifications.
15853920|NCT04011228|Diagnostic Test|Magnet Resonance Spectroscopy|The amount of ectopic lipids in the liver, heart and the skeletal muscle will be measured using 1H-magnetic resonance spectroscopy.
15853921|NCT04011215|Other|wool clothing|superfine merino wool ensembles for baby/child wear
15853922|NCT04011215|Other|standard clothing|Standard clothing refers to the clothing normally worn by the infant/child. This will not be superfine merino wool as superfine merino is not generally available for baby wear. The exact nature of the standard clothing will be recorded by investigators. From previous data we expect it to be primarily cotton.
15853958|NCT04010929|Procedure|Partial pulpotomy with MTA|After removing caries, MTA was applied to the exposed area on the pulp following bleeding control with 5.25% NaOCl.
15854037|NCT04010240|Other|Retrospective cohort|Tumor material tested positive will be analyzed by next-generation sequencing to identify NTRK1, NTRK2 or NTRK3 gene fusions.
15853923|NCT04011202|Behavioral|Virtual reality gaming program (VR-gaming program)|Participants in the VR-gaming program will receive three 20-30 minutes sessions of VR-gaming per week for the duration of their inpatient stay. Participants will select VR games/program in categories of: Relaxation; Leisure sport and activities; or Action/adventure. The VR-gaming program will be implemented one-on-one, face-to-face by a clinician using the commercially-available Oculus Go system.
15853924|NCT04011189|Procedure|Videotaping|Before the videotaping, patients will be asked on their baseline pain scores. Their face and body pose from a frontal view will be videotaped via a mobile phone with no internet access. The collected videos will be further processed to extract keypoints (70 points to capture key facial landmark locations and 25 points to capture joint locations), which will be the primary input for modeling algorithms and will further ensure anonymity of the patients in the video sequences.
15853925|NCT04011189|Other|Questionnaires|Patients will be asked to fill in two questionnaires before surgery (Hospital Anxiety and Depression Scale (HADS), EQ-5D-3L). After surgery, patients will be again asked to fill in HADS questionnaire daily post-operatively.
15853926|NCT04011176|Procedure|Standard treatment + placebo|Placebo microcurrent
15853927|NCT04011176|Procedure|Standard treatment + Microcurrent Therapy|Actual microcurrent
15853928|NCT04011163|Device|VPIA pump|The pump is a specially designed and manufactured infusion syringe pump for intravenous analgesia. It incorporates the VPIA study regimen to meet the specific requirements of the clinical trial. It is intended to be used only for delivering drugs intravenously.
15853929|NCT04011163|Drug|Morphine|Intravenous medication used is morphine diluted in normal saline to a concentration of 1mg/ml. This is a standard dilution and are routine drugs used as standard of care.
15853930|NCT04011150|Device|Epidural infusion pump|Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.
15853931|NCT04011150|Drug|Ropivacaine|Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.
15853932|NCT04011150|Drug|Fentanyl|Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.
15853933|NCT04011137|Other|Exercise|Arm-cranking exercise
15853934|NCT04011124|Drug|Fluzoparib|single dose on Day 1 and Day 12
15853935|NCT04011124|Drug|Rifampicin|QD on Day 5-14 for 10 days
15853936|NCT04011111|Procedure|Intubation tube and voice analysis|After the ıntubation tube application, done voice analysis early postoperative period
15853937|NCT04011098|Drug|Epidural Fentanyl Bolus|Fentanyl bolus refers to the provision of a 2 ml bolus of epidural Fentanyl (50 mcg/ml; therefore a total dose of 100 mcg) after epidural placement, followed by a standard care infusion of epidural local anesthetic/opioids, with a PCEA pump for subsequent analgesia (0.08% Bupivicaine with 2 mcg/ml Fentanyl Solution).
15853938|NCT04011098|Drug|Standard Epidural Group|The Control group will receive a 2 ml bolus of standard epidural mix solution (0.08% Bupivicaine with 2 mcg/ml Fentanyl) after epidural placement followed by standard care infusion of the same solution, with a PCEA pump for subsequent analgesia.
15853939|NCT04011072|Radiation|Far infrared radiation|The treatment group will receive FIR for 40 minutes on the skin above the fistula during each dialysis session for one year.
15853940|NCT04011059|Biological|Wharton's jelly-derived mesenchymal cells|Revascularization surgery, placement of an extracellular matrix patch with WJ-MSCs cultured on the epicardial surface and injection of WJ-MSC around the infarcted zone.
15853941|NCT04011046|Device|Stent|
15853942|NCT04011033|Biological|iNKT cells|5×10^8-10^9/m2 iNKT cells will be infused to patients at 1st, 3rd, 5th, 7th, 8th and 12th week.
15853943|NCT04011033|Drug|Cyclophosphamide|CTX will be administered intravenously at a dose of 750mg/m2 2 days before the first iNKT cells infusion.
15853944|NCT04011033|Drug|Human recombinated Interleukin-2|IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days after iNKT cells infusion.
15853945|NCT04011033|Procedure|TACE|TACE will be conducted to all patients at 0th week and 4th week.
15853946|NCT04011020|Combination Product|Stem Cell Educator therapy|Patients with T1D will be evaluated by the study principal investigator or co-investigators. Informed consent will be obtained at the initial screening visit. The initial screening visit will occur within 30 days of initiation of SCE therapy. The second screening visit will occur within 7 days of therapy. Subjects who meet all criteria will be scheduled for treatment. All enrolled subjects will receive treatment with the SCE system consisting of a single session of mononuclear cells (MNC) collection by apheresis where 10 L of blood will be processed on day -1. The MNC product will then be exposed over to the SCE and on day 0 the product will be infused intravenously back to the patient.
15853947|NCT04011007|Procedure|vitrectomy with or without inverted ILM flap technique|vitrectomy without ILM peeling versus vitrectomy with inverted ILM flap technique in cases of macular hole retinal detachment in high myopic eyes.
15853948|NCT04010994|Procedure|Transorbital electrical stimulation|Transorbital ACS using 8-12 Hz with 0,5-1,5 mA Intensity, during the first two weeks 1/day, after 2/week for 10 weeks, as a home treatment
15853949|NCT04010981|Other|study group|The treatment protocol will consist of Nintendo wii fit virtual reality exercises (yoga,aerobic exercises,muscle strengthening exercises)
15853950|NCT04010981|Other|control group|The treatment protocol will consist of home based video exercises ;yoga,aerobic exercises,muscle strengthening exercises
15853951|NCT04010968|Drug|venetoclax and ibrutinib (I+VEN)|"The treatment will start with ibrutinib alone for 3 months (lead-in phase) from Month 1 to Month 3 and then venetoclax will be added from Month 4 with an initial ramp-up period.
~The total duration of treatment with (I+VEN) will depend on the response achieved at Month 9:
~if BM MRD at M9 < 0.01%, the treatment with (I+VEN) will be continued for 6 additional months until Month 15 and stopped then. MRD will be assessed at Month 15 (PB), Month 21 (PB) and Month 27 (PB and BM)
~if BM MRD at M9 ≥ 0.01%, the treatment with (I+VEN) will be continued for 18 additional months until Month 27 and stopped then, whatever the results of MRD assessments that will be performed at the same time points as above."
15853952|NCT04010968|Drug|FCR|"All patients will receive 6 cycles of FCR administered at 4 weeks intervals (D1 = D29) from Month 1 to Month 6.
~6 cycles of FCR will be administered at 4 weeks intervals (D1 = D29) from Month 1 to Month 6."
15855523|NCT03998241|Other|No intervention was provided|No intervention given
15853959|NCT04010916|Other|Group Preoperatively Adductor Canal Block|The ACB will be performed preoperatively before inflation of the tourniquet. After identifing the adductor canal, by using the in-plane technique, the probe will be placed at the mid-thigh, half the distance between the inguinal crease and the patella, for block location. The superficial femoral artery will be visualized dorsal to the sartorius muscle. Then, the probe will be remowed to distally. At this level, the hyperechoic view of the saphenous nerve will be visualized lateral and anterior to the artery in the subsartorial region. 5 mL of saline will be injected to confirm the proper injection site, and then a dose of 0.25% bupivacaine 30 mL will be injected here.
15853960|NCT04010916|Other|Group Preoperatively Tourniquet Adductor Canal Block|The ACB will be performed preoperatively after inflation of the tourniquet. After identifing the adductor canal, by using the in-plane technique, the probe will be placed at the mid-thigh, half the distance between the inguinal crease and the patella, for block location. The superficial femoral artery will be visualized dorsal to the sartorius muscle. Then, the probe will be remowed to distally. At this level, the hyperechoic view of the saphenous nerve will be visualized lateral and anterior to the artery in the subsartorial region. 5 mL of saline will be injected to confirm the proper injection site, and then a dose of 0.25% bupivacaine 30 mL will be injected here.
15853961|NCT04010916|Other|Group Postoperatively Adductor Canal Block|The ACB will be performed postoperatively. After identifing the adductor canal, by using the in-plane technique, the probe will be placed at the mid-thigh, half the distance between the inguinal crease and the patella, for block location. The superficial femoral artery will be visualized dorsal to the sartorius muscle. Then, the probe will be remowed to distally. At this level, the hyperechoic view of the saphenous nerve will be visualized lateral and anterior to the artery in the subsartorial region. 5 mL of saline will be injected to confirm the proper injection site, and then a dose of 0.25% bupivacaine 30 mL will be injected here.
15853962|NCT04010903|Diagnostic Test|assessment of biomarkers of insulin resistance|blood and urine sample collection for assays of BCAAs
15853963|NCT04010890|Behavioral|Culturally adapted CBT|Culturally adapted CBT for South Asian Canadians
15853964|NCT04010877|Biological|CLL-1, CD33 and/or CD123-specific CAR gene-engineered T cells|Infusion of CLL-1, CD33 and/or CD123-specific CAR-T cells
15853965|NCT04010864|Other|routine clinical treatment|Participants will be informed that this is not a treatment study and it involves naturalistic follow-up without any extra intervention. They will otherwise follow the routine clinical treatment procedure.
15853966|NCT04010851|Behavioral|Peer co-led educational group|The intervention is delivered in a group format, which takes the form of a full day's training, focusing on ADHD diagnosis, its treatment, how to cope with the challenges related to living with ADHD, as well as coping with challenges of parenting a child with chronic health conditions. After this one day-intervention, the participants can continue in self-help groups, which meet once a week for a 2-hour evening session. User representatives lead these weekly self-help groups, which do not require user-fees and aim to offer practical tools, support and information to increase the parent's skills, knowledge and confidence. Participants are encouraged to adopt an active role in order to achieve a positive parent/provider partnership.
15853967|NCT04010851|Behavioral|Comparator treatment as usual|Control group will receive treatment as usual, including different treatment options that can help alleviate the symptoms of ADHD and arm families with the tools needed to better handle problem behaviors when they arise. These interventions include: medication, psychotherapy, or a combination of these two approaches.
15853968|NCT04010838|Procedure|spinal cord stimulation|The spinal cord stimulation(SCS) is a type of implantable neuromodulation device (spinal cord stimulator) that is used to send electrical signals to select areas of the spinal cord (C2-C4 in this study) for the treatment of disorders of consciousness.
15853969|NCT04010825|Other|Hypnosis intervention focused on the emotional dimension of the dyspnea|Individual hypnosis sessions will be for 1 hour. Each hypnosis session will be standardized and evaluated using a script and an observation grid ( Visual Analogic Scale comfort, patient's hypnotic state...) written in collaboration with experts from Institut Milton Hyland Erickson Toulouse France (IMHETO).
15853970|NCT04010812|Other|Questionnaire|RHDS- Readiness For Hospital Discharge Scale, Patient Self-Assessment Form
15853971|NCT04010799|Drug|CHF 6333|CHF 6333 - Part I - SAD CHF 6333 - Part II - MD
15853972|NCT04010799|Drug|Placebo|Placebo - Part I - SAD Placebo Part II - MAD
15853973|NCT04010786|Drug|NNC0247-0829|Participants will receive either single or multiple doses given subcutaneously (s.c., under the skin) in a lifted fold of the stomach skin. Dose level and number of doses will depend on the cohort.
15853974|NCT04010786|Drug|Placebo (NNC0247-0829)|Participants will receive either single or multiple doses of placebo given s.c. in a lifted fold of the stomach skin.
15853975|NCT04010773|Other|collective and psycho-social intervention|The intervention duration is 1 year. It combine (1) In each unit, working groups aimed at improving QWL, (2) counseling and training of directors and frontline managers, and (3) in each unit, concertation meeting between workers, front-line managers and directors.
15853976|NCT04010760|Diagnostic Test|Test of biomarkers for PE in EBC|"New method for diagnosis of pulmonary embolism (PE) in order to validate/consolidate 151 putative identified biomarkers for PE in the exhaled breath condensate (EBC).
~The EBC will be collected by use of the RTube(R) system which has been used in previous studies of EBC. As the patient breathes through a mouth piece, the exhaled breath is led through a cooling chamber where the vaporous part of the exhaled breath condenses.
~We aim at collecting a total minimum of 3.0 mL EBC per study subject in order to have a sufficient amount of protein for the subsequent analysis. We aim at collecting exhaled breath condensate for 2*15 minutes with the possibility to stop the collection after less than 15 minutes if the volume is sufficient."
15853977|NCT04010747|Behavioral|Motivational Interviewing for Loved Ones (MILO)|4 sessions of behavioral coaching in motivational interviewing communication techniques
15853978|NCT04010747|Behavioral|Mental Health Services Consultation and Waitlist|1 session of individualized consultation on relevant mental health services for the IP and participating PCSO and 6 weeks on a waitlist, followed by opportunity to participate in MILO sessions.
15853979|NCT04010734|Procedure|Peroral Cholangioscopy and Endoscopic retrograde cholangiopancreatography|"The peroral cholangioscopy (DSOC), one of a newer method of endocanal exploration via ERCP- commonly known as the SpyGlass - helps to provide the visual diagnostics of the strictures based on morphological and vascular patterns and to provide directed intraductal biopsy (SpyBite) from the lesions. The combination of both should increase the diagnostic yield in the evaluation of indeterminate biliary stricture by DSOC.
~ERCP is the most widely used diagnostic procedure in patients with biliary obstruction. It enables to identify the biliary stricture, to determinate its location and help providing tissue sampling from the stricture for cytological evaluation. Different methods were used to take samples from the site of the stenosis. Brushing and endocanal forceps biopsies were the most used techniques. The samples from these two techniques will be additionaly examinated using Fluorescence in Situ Hybridization (FISH)."
15853983|NCT04010708|Diagnostic Test|Urinary Iodine Concentration Measurement|UIC
15853984|NCT04010695|Diagnostic Test|SD Biosensor G6PD Analyzer|The SD Biosensor G6PD Analyzer is designed to measure the quantitative determination of total hemoglobin concentration and G6PD enzymatic activity in fresh human whole blood specimens based on reflectometry assays in a point-of-care setting. The test is intended to aid in the identification of people with G6PD deficiency. The test is currently not licensed for use in the US and is considered an investigational product.
15853985|NCT04010695|Diagnostic Test|Pointe Scientific Test Kit|The Pointe Scientific test kit will serve as the reference assay to assess G6PD activity. Its intended use is for the quantitative, kinetic determination of G6PD in blood at 340 nm.
15853986|NCT04010695|Diagnostic Test|HemoCue System|The HemoCue hemoglobin (Hb) 201+ system is designed for quantitative point-of-care whole blood hemoglobin determination in primary care using a specially designed analyzer, the HemoCue Hb 201+ Analyzer, and specially designed microcuvettes, the HemoCue Hb 201+Microcuvettes.
15853987|NCT04010682|Other|urine sample collection|no drug/devise intervention. sample collection study only
15853988|NCT04010669|Drug|Somatostatin|2 amp of somatostatin at 1000ml normal saline solution in continuous 24-hour infusion for 5 days
15853989|NCT04010669|Drug|Placebo|24 hours infusion of 1000ml Normal Saline solution 0.9%
15853990|NCT04010656|Procedure|PVR-based self-catheterization|Home self-catheterization based on standard of care
15853991|NCT04010643|Behavioral|online cognitive behavioural therapy|oCBT: MoodGym is a 5-week oCBT program developed by the Centre for Mental Health Research at the Australian National University. This program has been shown to be clinically effective at reducing mood symptoms in depression studies (see meta-analytical review of Twomey & O'Reilly, 2017). MoodGym consists of a number of interactive modules to be completed sequentially and including work on own feelings, thoughts, methods to change dysfunctional thinking patterns, de-stressing, and relaxation. Each module is followed by an associated practical homework, while a personalised workbook allows the participant to track their mood profile and progress throughout the modules.
15853992|NCT04010643|Behavioral|online neurocognitive remediation therapy|NCRT involves the behavioural application of structured exercises targeting neurocognitive processes by mobilising neuroplasticity that is the brain's ability to adjust its function in response to environmental change. Computerised NCRT has demonstrated efficacy to improve attention, working memory and global functioning in depression (Motter et al., 2016; Semkovska et al., 2015). NCRT is delivered through the Cognifit online programme. The Cognifit modules were selected as targeting remediation of neurocognitive domains known to be impaired in depression, i.e. selective and divided attention, visual and verbal working memory, and everyday planning (Hammar and Ardal, 2009; Semkovska et al., 2019).
15853993|NCT04010630|Drug|Sodium bicarbonate infusion|"Patients randomly assigned to bicarbonate group will receive intravenous 4.2% sodium bicarbonate titrated from 125ml to 250ml in 30min at physician's discretion to target a pH equal or above 7.30. Bicarbonate infusion will be repeated up to 1000ml per 24h. Arterial blood gases will be repeated from 3 to 6 times during the first 24h at physician's discretion.
~Bicarbonate infusion recommendations will be as follow: a central line is recommended, infusion will be slow (125-250ml in 30 min, no intravenous push), careful surveillance of metabolic alkalosis, cardiogenic pulmonary edema, kalemia, natremia and calcemia. Repeated arterial blood gases will be suggested to monitor these critically ill patients and physicians will be reinformed of the potential side effects of sodium bicarbonate infusion."
15853994|NCT04010617|Device|Pharyngeal Electrical Stimulation (PES)|PES will be delivered by a commercial device (Phagenyx, Phagenesis Ltd, Manchester, UK), which comprises a nasogastric feeding catheter that houses stimulation ring-electrodes and a computerised base station that delivers stimulation in the range 1-50 mA at 5 Hz.
15853995|NCT04010591|Device|impedance measurement during urodynamic study|Impedance information is measured through the belt in the abdomen of the subject. The urodynamic test is performed from the state in which the urine of the bladder is completely emptied to the state of the bladder until the state becomes full, so the impedance measurement is measured from the state where the urine of the bladder is completely emptied to the state of the bladder until the state becomes full.
15853996|NCT04010578|Dietary Supplement|MK-7 and vitamin D3|Patients will receive 400 micro-grams of Menaquinone-7 and 80 micro-grams of vitamin D3 per day.
15853997|NCT04010578|Other|Placebo|Patients will receive a placebo each day.
15853998|NCT04010565|Dietary Supplement|Aged black garlic extract|"Participants will intake a tablet with 250 mg of a aged black garlic extract with higher concentration of bioactive compounds S-allyl cysteine and alliin, and minor unwanted compounds such as simple sugars and furfural derivatives.
~In addition, during the course of the study, participants will be urged to follow dietary guidelines according to a heart-healthy diet established by nutritionists and that they will adhere to European guidelines for the treatment of dyslipidemias."
15853999|NCT04010565|Dietary Supplement|Placebo|Participants will intake a tablet with 250 mg of microcrystalline cellulose. In addition, during the course of the study, participants will be urged to follow dietary guidelines according to a heart-healthy diet established by nutritionists and that they will adhere to European guidelines for the treatment of dyslipidemias.
15854000|NCT04010552|Drug|NALRINOX combination|NALRINOX: combination of three chemotherapy agents: 5- FU/LV, nal-IRI, and oxaliplatin
15854138|NCT04009460|Drug|ES101|ES101 is administered via intravenous infusion, once every 14 days, every 28 days as a treatment cycle.
15854004|NCT04010526|Combination Product|local co-administration of autologous ADIpose|local co-administration of autologous ADIpose derived stromal vascular fraction and microfat for refractory perianal CROHN's fistulas Each batch of the final product is composed of one 5 mL syringes containing 25,9 +/- 10,7 millions viable cells. Each syringe will be obstructed with a sterile stopper and packaged in an external packaging.
15854005|NCT04010526|Other|placebo|local co-administration of placebo The study placebo will consist of a saline solution for intralesional administration and will follow the same administration schema described for the SFV
15854006|NCT04010513|Behavioral|Hypnosis|Women in the hypnosis group will undergo treatment with three in-person hypnosis sessions and will be given access to hypnosis web-app for at home practice.
15854007|NCT04010513|Other|Standard of Care|Women in the usual care group will continue their usual care for BPS/IC as dictated by their physicians.
15854008|NCT04010500|Device|no mouthguard|Control (not using mouthguard)
15854009|NCT04010500|Device|'boil and bite' mouthguard|KHZ058 Bicolor Mouth Guard (Shenzhen Kanghao Industrial Co. Ltd, China) will be immersed in a bowl of hot water (about 80 °C). After 50 seconds, the softened sheet will be fitted on the maxillary arch of the participant. The participant will then bite down to ensure the mouthguard stay firmly on the maxilla. After that, the mouthguard will be removed and immersed in cold water to retain its shape.
15854010|NCT04010500|Device|custom-fitted mouthguard|The custom-fitted mouthguards will be constructed using the dual laminated technique with two layers of ethylene vinyl acetate (EVA) thermoplastic sheets (Dentsply International Raintree Essix, Court East Sarasota, USA).
15854011|NCT04010487|Genetic|whole exome sequencing and RNA-sequencing|The specimens from adenomyosis, endometrial cancer, and eutopic endometrium will be tested by whole exome sequencing and RNA-sequencing
15854012|NCT04010474|Procedure|Modified Surgical APGAR Score|"Four intraoperative factors
~Lowest heart rate (HR),
~Lowest mean arterial pressure (MAP)
~Estimated blood loss
~Operation time"
15854015|NCT04010448|Biological|TV P2-VP8|90 µg of the TV P2-VP8 vaccine IM plus oral placebo administered on study days 1, 29 and 57
15854016|NCT04010448|Biological|Rotarix|Rotarix® PO plus IM placebo administered on study days 1, 29 and 57
15854017|NCT04010435|Device|repetitive transcranial magnetic stimulation|high frequency (10 HZ) rTMS pulses are applied to the dorsolateral prefrontal cortex of the dominant hemisphere.
15854018|NCT04010435|Device|Galvanic stimulation|galvanic stimulation of the vestibular apparatus
15854019|NCT04010422|Diagnostic Test|no intervention|no intervention
15854020|NCT04010409|Other|no intervention|no intervention
15854021|NCT04010396|Other|Blood sampling|Blood sampling: 1 EDTA and 1 Serum vial
15854022|NCT04010383|Diagnostic Test|virtual reality perimeter|Both groups will be examined with a standard automated perimeter as well as with the virtual reality perimeter.
15854023|NCT04010357|Drug|Abemaciclib,|Abemaciclib (CDK4/6 inhibitors) is an investigational drug that works by interrupting the rapid and uncontrolled growth of cancer cells. Some cancer cells develop because their cells overrun the molecular brakes that normally permit cell to divide only when they are needed to replace old ones. These brakes are regulated by a group of enzymes known as cyclin-dependent kinases (CDKs). Alterations causing over-activity of two of these enzymes, CDK4 andCDK6, are found in a variety of cancers, including small cell lung cancer with retinoblastoma (Rb) protein.The drugs work by selectively turning off the overactive CDK4 and CDK6. As a result, the cancer cells' division cycle is halted, preventing them from proliferating.
15854024|NCT04010344|Behavioral|Enhanced Usual Care Group|"Medtronic® Labs' Akoma pa app, a culturally-tested and locally attuned mobile health platform, will be used in the intervention arm of the study to improve communication between the Community Health Officer (CHO) and the participant. This platform will be used to enhance shared decision making, clinical decision support, participatory communication, knowledge, treatment adherence (medication and lifestyle modification), and self-monitoring of hypertension. We will test the feasibility of the Akoma pa app in addressing patient-level and provider-level barriers to hypertension control.
~The app will consist of the following components:
~Reminders
~Participant to CHO messaging
~Home BP tracking
~Educational materials on cardiovascular disease (CVD) and Stroke- Participants will have access to education modules on reducing the risk of CVD and stroke tailored to their knowledge level.
~CHO provider portal- The provider portal will include decision support tools."
15854025|NCT04010344|Other|Usual Care Group|Regular/usual appointments or visits to patients' healthcare provider for management of study outcomes
15854026|NCT04010331|Dietary Supplement|Nokyong Mixture Extract(CME-PI)|2 times a day, 2 capsule for 1 time, after breakfast/dinner meal, for 8 week
15854027|NCT04010331|Dietary Supplement|Placebo|Placebo for 8 week
15854028|NCT04010318|Procedure|Spinal Anesthesia|The patients will receive spinal block at lumbar 3-4 space with hyperbaric bupivacaine 8 mg plus 25 mic fentanyl. After giving anesthesia and positioning for surgery with a left lateral tilt of 15 degrees, supplemental oxygen at rate of 4 liter/minute is applied.
15854029|NCT04010305|Drug|Sublingual film containing BXCL501 (Dexmedetomidine)|Sublingual film containing BXCL501 (Dexmedetomidine) for the treatment of agitation associated with Schizophrenia
15854030|NCT04010305|Drug|Placebo film|Placebo film for BXCL501
15854031|NCT04010292|Behavioral|Patient education card|Patient who are randomized to receive a patient card at the end of the counseling visit will be able to take an index-card sized card with them which will highlight their anticipated surgery.
15854032|NCT04010279|Procedure|preoxygenation with 100% O2, fresh gas flow rate 12 L/minute|volunteers will be placed in supine position, fresh gas flow rate will be set at 12 L/min and delivered oxygen concentration will be set at 100%.
15854033|NCT04010266|Device|RelieVRx headset|RelieVRx is a virtual reality therapy intended as adjunctive treatment for acute surgical pain
15854034|NCT04010266|Drug|multi-modality pain management|combination of medications may be used such as a local anesthesia, ibuprofen, acetaminophen, gabapentin, ketamine, lidocaine, and opioids
15854035|NCT04010253|Device|SIMEOX|Instrumental airway clearance by the medical device SIMEOX
15854036|NCT04010253|Other|Autogenic drainage|Manual aiway clearance by autogenic drainage
15854038|NCT04010227|Behavioral|Acceptance and Commitment Therapy|Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers practice various mindfulness exercises, clarify their values, and set specific goals in alignment with their values. Through in-session and home practice of skills, participants learn new and more adaptive ways to respond to unwanted internal experiences (e.g., fatigue, distress). Participants receive handouts on session topics and a CD that we developed to guide mindfulness practices.
15854039|NCT04010227|Behavioral|Education/Support|Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers are directed to resources for practical and health information and contact information for psychosocial services. Sessions include an orientation to the patient's medical center and treatment team, education regarding common quality-of-life concerns experienced by cancer patients and caregivers, and an overview of medical center and community resources for addressing these concerns. The therapist also describes resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants receive handouts summarizing session topics and are asked to review them as homework.
15854040|NCT04010214|Other|No intervention|No intervention
15854041|NCT04010175|Behavioral|Control - Cognitive training in a practitioner's office one time per week|Participant will perform 1-hour cognitive computer based training one time per week in a practitioner's office during 4 months (16 weeks of training = 16 hours of training). This training will include 10 short tasks of increasing difficulty. Performance of these tasks involve cognitive functions such as: executive functions, reasoning, auditive, visual and visuo-spatial memory, speed of processing, short-term memory and working memory. Thus the training aims to exercise all these cognitive functions.
15854042|NCT04010175|Behavioral|Experimental group 1 - Cognitive training in a practitioner's office one time per week and cognitive distance training one time per week|Participant will perform 1-hour cognitive computer based training one time per week in a practitioner's office and one time per week cognitive distance training in her/his place of residence, during 4 months (16 weeks of training = 32 hours of training).
15854043|NCT04010175|Behavioral|Experimental group 2 - Cognitive training in a practitioner's office one time per week and cognitive distance training four times per week|Participant will perform 1-hour cognitive computer based training one time per week in a practitioner's office and four times per week cognitive distance training in her/his place of residence during 4 months (16 weeks of training = 80 hours of training).
15854044|NCT04010162|Other|Mesh debate awareness survey|"A web-based questionnaire with questions about recent discussions of mesh in urogynecology.
~10 questions. Average survey completion time: 1 minute"
15854045|NCT04010149|Device|Active tDCS|For the first two weeks of the study, participants will receive 20 min of brain stimulation, concurrent with cognitive training. Electrodes will be placed over the dorsolateral prefrontal cortex (active electrode), and the contralateral supraorbital site (return electrode).
15854046|NCT04010149|Device|SHAM tDCS|For the first two weeks of the study, participants will receive 20 min of SHAM brain stimulation, concurrent with cognitive training. Electrodes will be placed over the dorsolateral prefrontal cortex (active electrode), and the contralateral supraorbital site (return electrode).
15854047|NCT04010136|Other|Palliative care training|Intervention will consist on providing different types of palliative care training to identify the most accurate on improving GPs' identification of palliative care patients skills
15854048|NCT04010123|Device|Atherectomy/Thrombectomy|Percutaneous transluminal removal of thrombotic, thromboembolic and atherothrombotic material from fresh, subacute and chronic occlusions of blood vessels in native blood vessels or vessels fitted with stents, stent grafts or native or artificial bypasses.
15854049|NCT04010110|Diagnostic Test|visual field testing (10-2), spectral domain ocular coherence tomography and Fundus auto-fluorescence|The diagnosis of toxic retinopathy was based on the positivity of at least two objective tests to confirm the subjective findings. The presence or absence of toxicity was recorded.
15854050|NCT04010097|Other|chewing gum|The test involves chewing a chewing gum for 4 minutes
15854051|NCT04010084|Radiation|Low level laser therapy|"The irradiation will be applied transcutaneously in the sublingual region (3 points on the left side and 3 points on the right side), irradiated for 30 seconds and the total treatment time will be 3 minutes. The group will receive irradiation with a DMC-branded laser EC device, with combined wavelength (660 and 780 nm), 1J of energy per point and output power of 35 mW. A disposable plastic material covering the application pen will be used for hygiene reasons.
~The treatment will be performed twice weekly for a total of 4 consecutive weeks of treatment, and after completion, the patients will be reassessed of all the complementary tests that have been requested."
15854052|NCT04010084|Procedure|Placebo group|"The irradiation will be applied transcutaneously in the sublingual region (3 points on the left side and 3 points on the right side), irradiated for 30 seconds and the total treatment time will be 3 minutes. The group will receive placebo (with switched-off) irradiation of the DMC-brand laser therapy EC model, with combined wavelength (660 and 780 nm), 1J of energy per point and output power of 35 mW. A disposable plastic material covering the application pen will be used for hygiene reasons.
~The treatment will be performed twice weekly for a total of 4 consecutive weeks of treatment, and after completion, the patients will be reassessed of all the complementary tests that have been requested."
15854053|NCT04010071|Drug|axitinib plus toripalimab|"Axitinib 5mg, twice a day, orally, 4 weeks a cycle. Dose reduction from 5mg twice a day to 3mg twice a day should be considered according to adverse events.
~Toripalimab 240mg, every 3 weeks, intravenous infused, 6 weeks a cycle. Number of cycle: until disease progression or unacceptable toxicity events."
15854054|NCT04010058|Device|LIDCO CNAP device|The LiDCO CNAP device (referred to as CNAP in this document) provides continuous cardiac output non-invasively, without the requirement for an arterial catheter. It uses a dual finger cuff in addition to a standard arm cuff (familiar to everyone who's had their blood pressure checked) and it transforms infrared plethysmographic signals into continuous blood pressure information. It uses an algorithm to derive cardiac output-related parameters. In recognition of the potential difference between the derived values and any measured values, it refers to some of its values as 'nominal' values. It has been evaluated in a range of surgical populations8-11 a post-operative cohort12, and a haemodynamically unstable critical care population13. In a population of patients undergoing endoscopy there was increased detection of episodes of hypotension compared with standard measures.
15854055|NCT04010045|Device|Endovascular Treatment of PAD|PAD endovascular treatment using the DABRA Laser System + other FDA cleared/ approved devices for the treatment of PAD.
15854056|NCT04010032|Device|Programmed intermittent epidural bolus|bolus administration of 0.15 ml of ropivacaine 0.15 ml / kg into epidural space every hour(intermittent bolus injection) using PCA device
15854057|NCT04010032|Device|Continuous epidural infusion|Continuous infusion of 0.15% ropivacaine 0.15 ml / kg / h into the epidural space using PCA device using PCA device
15854058|NCT04010019|Behavioral|Enhanced Facebook Condition|The intervention (enhanced Facebook condition) will consist of several training components that were selected based on pain research and platform affordances. The first component will be psychoeducation on pain neurobiology. Emotional validation training will follow. The third component will consist of facilitating patients' emotional disclosure about their pain journeys and lives. The fourth and final intervention component will include prompts to engage participants in activities that they have been avoiding because of their pain.
15854059|NCT04010019|Behavioral|Control Facebook Condition|The control condition will instruct participants to offer mutual support and will not offer psychosocial intervention.
15854060|NCT04010006|Procedure|4K Laparoscopic Surgery|4K Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.
15854061|NCT04010006|Procedure|HD Laparoscopic Surgery|HD Laparoscopic Surgery will be performed for the treatment of patients assigned to this group.
15854062|NCT04009993|Device|A-BIRTHPERFORM digital tool|use of A-BIRTHPERFORM digital tool
15854063|NCT04009980|Other|OMK2 group|topical administration of OMk2 ophthalmic solution for 36 months three times/day
15854064|NCT04009980|Other|Placebo group|topical administration of ophthalmic placebo solution for 36 months three times/day
15854065|NCT04009967|Drug|Pembrolizumab|Pembrolizumab 200 mg every three weeks for 3 cycles only
15854066|NCT04009954|Other|Fecal and blood samples collection for analysis|"Fecal sample analysis will consist of the following procedure : Microbial DNA extraction, amplicon library construction, sequencing and analysis; Clustering MiSeq reads into operational taxonomic units (OTUs)."
15854067|NCT04009941|Drug|PEG-rhG-CSF|4.5mg per cycle, 24 hours after chemotherapy
15854068|NCT04009928|Device|Active stimulation of the medial forebrain bundle or subcallosal cingulate|Deep brain stimulation of the medial forebrain bundle or subcallosal cingulate
15854069|NCT04009928|Device|Sham stimulation|Sham stimulation for 2 weeks (Cross-over design)
15854070|NCT04009915|Procedure|VATS|Patients undergo a standard VATS operation for stage II-III lung cancer called a lobectomy.
15854071|NCT04009915|Procedure|Open surgery|Patients undergo a standard open operation for stage II-III lung cancer called a lobectomy.
15854072|NCT04009902|Behavioral|Beck Depression Scale and Pittsburgh Sleep Quality Index|postoperative depression and sleep disorders in patients with endometriosis will be evaluated
15854073|NCT04009889|Dietary Supplement|capsule containing a probiotic blend of 5 different Lactobacilli|n=81 women (verum) starts before end of pregnancy week 14 with consumption of 1 capsule daily until delivery.
15854074|NCT04009889|Other|capsule containing Microcrystalline Cellulose, Magnesium Stearate, Silicon Dioxide, but no probiotics.|n=81 women (placebo) starts before end of pregnancy week 14 with consumption of 1 capsule daily until delivery.
15854075|NCT04009876|Drug|nal-IRI|Treatment with 5-FU/LV + Oxaliplatin + nal-IRI for 8 cycles followed by standard chemoradiation (5 weeks)
15854076|NCT04009876|Procedure|Surgical resection|Surgical resection of the tumour
15854077|NCT04009876|Other|Watch-and-wait|No surgery approach
15854078|NCT04009876|Drug|5-FU/LV|Treatment with 5-FU/LV + Oxaliplatin + nal-IRI for 8 cycles followed by standard chemoradiation (5 weeks)
15854079|NCT04009876|Drug|Oxaliplatin|Treatment with 5-FU/LV + Oxaliplatin + nal-IRI for 8 cycles followed by standard chemoradiation (5 weeks)
15854080|NCT04009863|Device|Echopulse|Echopulse is a real-time US-guided High-intensity focused ultrasound (HIFU) system, the HIFU session is a noninvasive procedure that involves application of a focused high-energy ultrasound beam for thermal tissue ablation inside the targeted zone, with minimal effect on the surrounding tissue
15854081|NCT04009863|Radiation|Radioactive iodine (Radioidine i131)|Radioactive iodine (RAI) is a radioactive form of iodine that for ablation in thyroid disease (i.e. Graves' disease or few thyroid cancer)
15854082|NCT04009850|Other|Cigarette Brand Switching|Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes
15854083|NCT04009850|Other|E-cigarette Flavor|Adult smokers will be provided with either menthol or tobacco flavored e-cigarettes in addition to the non-menthol cigarettes
15854084|NCT04009837|Behavioral|Hip-focused rehabilitation intervention|The hip-focused intervention includes a blend of hip-focused rehabilitative techniques and some basic lumbar spine-directed techniques. The hip-focused arm includes tailored manual therapy, progressive strengthening exercises, and flexibility exercises for the hip, as well as spinal flexibility and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
15854085|NCT04009837|Behavioral|Spine-focused rehabilitation intervention|The spine-focused rehabilitation intervention is a direct and comprehensive lumbar spine rehabilitative program, but it does not include hip treatment. The spine-focused arm includes spinal manual therapy, spinal flexibility exercises, and trunk muscle training exercises. The intervention will be delivered by licensed physical therapists in one-hour sessions, twice per week, for 8 weeks.
15854086|NCT04009824|Biological|AGS-v PLUS Vaccine|Administered by subcutaneous injection
15854087|NCT04009824|Biological|Montanide ISA-51 Adjuvant|Administered by subcutaneous injection
15854088|NCT04009824|Biological|Alhydrogel® Adjuvant|Administered by subcutaneous injection
15854089|NCT04009824|Biological|Saline Placebo|Administered by subcutaneous injection
15854090|NCT04009811|Device|Suersen and membraneous obturators evaluation|"The patient will wear one month each obturator prothesis (Suersen and membraneous obturators). The order of evaluation will be randomized in two arms.
~Half of patient will first wear one month the membranous obturator then one month the Suersen, the other half of patient will first wear one month the Suersen obturator and one month the membranous obturator."
15854091|NCT04009772|Drug|Cefepime|Antibiotic prophylaxis
15854092|NCT04009772|Drug|Cefuroxime plus Metronidazole|Antibiotic prophylaxis
15854137|NCT04009473|Combination Product|SEGOVA procedure|SEGOVA procedure includes - Stem cell therapy, G - Growth factor Platelet Plasma Rich therapy and in Vitro Activation of the ovaries.
15857495|NCT03982381|Drug|Metformin|Active comparator
15854093|NCT04009759|Drug|Morphine|Adult patients with an in-hospital cardiac arrest will be evaluated by anaesthesiologists for inclusions criteria to the study and randomised to get the blinded study medicine as addition to standard treatment of cardiac arrest. Randomization will be performed by means of sealed envelopes containing number of syringe that will be used.
15854094|NCT04009759|Drug|Ketamine Injectable Solution|Adult patients with an in-hospital cardiac arrest will be evaluated by anaesthesiologists for inclusions criteria to the study and randomised to get the blinded study medicine as addition to standard treatment of cardiac arrest. Randomization will be performed by means of sealed envelopes containing number of syringe that will be used.
15854095|NCT04009759|Drug|Saline 0.9%|Adult patients with an in-hospital cardiac arrest will be evaluated by anaesthesiologists for inclusions criteria to the study and randomised to get the blinded study medicine as addition to standard treatment of cardiac arrest. Randomization will be performed by means of sealed envelopes containing number of syringe that will be used.
15854096|NCT04009746|Procedure|Endoscopic retrograde cholangiopancreatography (ERCP) with Spyglass|Endoscopic retrograde cholangiopancreatography (ERCP) with Spyglass
15854097|NCT04009733|Biological|Blood sample|A study specific blood sample will be collected.
15854098|NCT04009733|Biological|Blood sample|Pre-collected serum of cohort OFELY and MODAM for women, STRAMBO for men will be used for the study.
15854099|NCT04009720|Device|Lotus Edge Device|The LOTUS Edge Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] <1.0 cm2 or AVA index <0.6 cm2/m2) who are at high risk for standard surgical valve replacement.
15854100|NCT04009707|Other|MoCA (Montreal Cognitive Assessment) test|the MoCA questionnaire is used to assess cognitive disorders
15854101|NCT04009707|Other|BEARNI (Brief Evaluation of Alcohol Related Neuropsychological Impairment) Test|This questionnaire is used to assess cognitive disorders
15854102|NCT04009694|Other|Pelvic Floor Muscle training|Sixteen weeks of supervised pelvic floor muscle training with a specialist physiotherapist
15854103|NCT04009681|Drug|THOR-707|THOR-707 will be administered as specified under Arm description.
15854104|NCT04009681|Drug|Checkpoint inhibitor|Checkpoint inhibitor will be administered as specified under Arm description.
15854105|NCT04009681|Drug|anti-EGFR antibody|anti-EGFR antibody will be administered as specified under Arm description.
15854106|NCT04009668|Drug|adalimumab|Adalimumab will be dosed based on weight
15854107|NCT04009655|Other|music|music selected by musician
15854108|NCT04009642|Other|Surely observational based on disease state|Metabolism in T2DM vs non diabetic
15854109|NCT04009629|Behavioral|Moderate Intensity Aerobic Exercise|Participants will exercise for 15 minutes in a moderate age-predicted heart rate range. The study team will employ an exercise device such as a treadmill, cycle, or recumbent stepper to maintain control over workload.
15854110|NCT04009616|Drug|Aloe Vera mouthwash|rinsing with aloe vera mouthwash for 5 days.
15854111|NCT04009616|Drug|Chlorhexidine mouthwash|rinsing with chlorhexidine mouthwash for 5 days.
15854112|NCT04009616|Drug|Placebo mouthwash|rinsing with placebo mouthwash for 5 days.
15854113|NCT04009603|Drug|Probiotic Agent|"Probiotics are live microorganisms, which when administered in adequate amounts confer a health benefit effects on the host.
~Many clinical trials have been done on probiotic which show its use as a single or as an adjuvant drug therapy for various diseases with no or rare side effects. It is now frequently used agent for various diseases.
~Apart from this many studies have been published related to effects of probiotics on PCOS, which shows effectiveness of probiotics when used for 8 to 12 weeks with no adverse effects observed by these micro-organisms but none of the study have compare it with standarad drug"
15854114|NCT04009603|Drug|Metformin|"Metformin, an insulin sensitizer, is an oral biguanide that is most commonly prescribed for the management of type II diabetes mellitus and various symptoms of PCOS. It is derived from the extract of Galega officinalis.
~It remediates hyperglycemia through activation of AMPK which stimulates glucose uptake and its consumption; promote fatty acid oxidation along with suppression of hepatic glucose production. It is also involved in increase GLUT4 translocation in the muscle and fat leading to decrease hepatic lipid synthesis. Moreover, It is also reported that it decreases gut absorption of glucose by increasing the glucagon-like peptide-1 (GLP-1) in this way, it reduces the insulin requirement too.All of these actions of metformin decrease insulin resistance and thus improve the state of hyperinsulinemia associated with diabetes and PCOS"
15854115|NCT04009590|Other|Educational Intervention|Read educational booklet
15854116|NCT04009590|Other|Questionnaire Administration|Ancillary studies
15854117|NCT04009590|Behavioral|Smoking Cessation Intervention|Utilize Quit4Health
15854118|NCT04009577|Drug|LEM 5 mg|LEM tablet.
15854119|NCT04009577|Drug|LEM 10 mg|LEM tablet.
15854120|NCT04009564|Dietary Supplement|Date coffee|45 g of date seeds coffee in 280 ml of water
15854121|NCT04009564|Dietary Supplement|Normal coffee|6 g of normal coffee in 280ml of water
15854122|NCT04009564|Dietary Supplement|Placebo|water, food colouring and coffee flavouring
15854123|NCT04009538|Other|Rehabilitation program|exercise program twice a week
15854124|NCT04009525|Drug|Busulfan|Busulfan（4 mg/kg/day,4 days）
15854125|NCT04009525|Drug|Cyclophosphamide|Cyclophosphamide（50 mg/kg/day,4 days）
15854126|NCT04009525|Drug|Fludarabine|Fludarabine（50 mg/m2/day,3 days）
15854127|NCT04009525|Drug|Thymoglobulin|Thymoglobulin（2.5 mg/kg/day,4 days）
15854128|NCT04009525|Drug|cyclosporine A|cyclosporine A
15854129|NCT04009525|Drug|Mycophenolate mofetil|Mycophenolate mofetil（0.25g/day）
15854130|NCT04009525|Drug|Tacrolimus|Tacrolimus
15854131|NCT04009525|Drug|Methotrexate|Methotrexate
15854132|NCT04009525|Drug|Basiliximab|Basiliximab
15854133|NCT04009525|Drug|Ruxolitinib|Ruxolitinib
15854134|NCT04009512|Device|Valiant Thoracoabdominal Stent Graft System|This system of devices works to facilitate endovascular stenting of the visceral vessels (renals, celiac, SMA) while maintaining flow to the visceral and infrarenal segments in patients with thoracoabdominal aneurysms.
15854136|NCT04009486|Device|Whole Body Vibration|"Subjects will undergo whole body vibration (standing on a power plate device 3 times a week, for 30 minute sessions, for 6 weeks)"
15854139|NCT04009447|Behavioral|Cognitive Behavioral Therapy for Insomnia (CBT-I)|6-week CBT-I therapy to help improve sleep quality
15854140|NCT04009434|Device|Mitral Valve Clipping|Patients receive treatment for mitral regurgitation with mitral valve clipping including standard drug therapy.
15854141|NCT04009434|Device|TAVI|Transfemoral transcatheter aortic valve implantation plus optimal standard of care therapy.
15854142|NCT04009421|Diagnostic Test|Coronary artery plaque assessment by CT coronary angiography QAngio CT RE|Assessment of segmental plaque volume and composition
15854143|NCT04009408|Device|Expiratory muscle strength therapy (EMST150, Aspire LLC)|Active therapy calibrated to the participant's maximum expiratory pressure
15854144|NCT04009395|Other|Pregnant Women qualitative interviewing|one-on-one in depth interviewing of pregnant African migrant women living in the UK on the barriers and facilitators to healthy eating in pregnancy.
15854145|NCT04009395|Other|Midwives qualitative interviewing|one-on-one interviewing/focus group discussions with midwives on their perspectives regarding the provision of healthy eating advice to pregnant African migrant women living in the UK.
15854146|NCT04009382|Other|Baduanjin Exercise|Subjects will participate in Baduanjin, a simple mind-body exercise, for 24 weeks.
15854147|NCT04009382|Other|Cognitive Fitness Program|Subjects will complete paper puzzles (Sudoku, crosswords, etc.) for 24 weeks.
15854148|NCT04009369|Other|Direct access to a PT|Direct access to a PT in the ED immediately after triage and prior to physician assessment.
15854149|NCT04009356|Procedure|bariatric surgical procedures|gastric bypass, sleeve, banding,biliopancreatic diversion
15854150|NCT04009343|Drug|Artemether-lumefantrine|Children will receive artemether-lumefantrine (20/120 mg) dosed according to weight (5 to <15 kg: 1 tablet, 15 to <25 kg: 2 tablets) at 0, 8, 24, 36, 48 and 60 hours. Medications will be administered according to the manufacturer's instructions.
15854151|NCT04009343|Drug|Dihydroartemisinin-piperaquine|Children will receive dihydroartemisinin-piperaquine (40/320 mg) dosed according to weight (5 to <8 kg: 1/2 tablet, 8 to <11 kg: 3/4 tablet, 11 to <17 kg: 1 tablet, 17 to <25 kg: 1 1/2 tablets) at 0, 24, and 48 hours. Medications will be administered according to the manufacturer's instructions.
15854152|NCT04009330|Diagnostic Test|POC Assay|"Interventions:
~Blood Baseline - up to 40ml Day 3 - up to 40ml
~Urine Baseline - 10ml Day 3 - 10ml
~Study population:
~Adults (18 plus) in ICU units diagnosed with ARDS."
15854153|NCT04009317|Drug|TQ-B3139|a multi-target protein kinase inhibitor.
15854154|NCT04009317|Drug|Crizotinib|a multi-target protein kinase inhibitor.
15854155|NCT04009304|Behavioral|OSNAP|Afterschool practice and policy change to support healthy eating and physical activity
15854156|NCT04009291|Combination Product|TransCon PTH|TransCon PTH drug product is supplied as a clear solution containing TransCon PTH with a nominal PTH(1-34) content of 0.3 mg/mL in a pre-filled pen intended for subcutaneous injection.
15854157|NCT04009291|Combination Product|Placebo for TransCon PTH|Placebo is supplied as a clear solution containing the formulation buffer for TransCon PTH in a pre-filled pen intended for subcutaneous injection.
15854158|NCT04009278|Other|Self compression arm|The optimal compression level up will be under the supervision of the radiographer who will interpose the compression when a level is reached beyond which there is no further reduction in thickness (15 daN). If the woman stops at a compression of less than 10 daN and that the radiographer considers not adequate to perform a quality mammogram, the radiographer will perform the compression in conventional mode and record the passage of compression mode.
15854159|NCT04009265|Combination Product|adjuvant treatment|adjuvant treatments include chemotherapy or chemoradiotherapy
15854160|NCT04009252|Behavioral|3D Model Education|A 3D model of the patients ankle fracture will be printed and used as a teaching tool to discuss long-term outcomes and potential complications.
15854161|NCT04009239|Behavioral|Time Restricted Feeding|Consuming energy during a short interval during the day
15854162|NCT04009226|Other|Patient Registry|Participants who have volunteered to participate will complete various questionnaires relating to their condition.
15854163|NCT04009213|Device|LiquiBand FIX8®|An n-butyl-2-cyanoacrylate adhesive monomer and D&C Violet #2 dye
15854164|NCT04009213|Device|AbsorbaTack™|An absorbable synthetic polyester copolymer derived from lactic and glycolic acid and is dyed with D&C Violet No. 2.
15854165|NCT04009187|Behavioral|In-person wheelchair propulsion training program|The wheelchair propulsion (WP) intervention is based on our previous pilot work and the best available evidence on WP training. The CPGs recommend minimizing the force and frequency of pushes while using long strokes during propulsion. Each training session will include massed practice with repetitions overground. Each session is organized to limit the number of variables (i.e., long push strokes and dropping the hands down below axle) presented to the participant at one time. Propulsion Set A will focus on using longer push strokes. Propulsion Set B will focus on dropping the hand down toward the axle. Propulsion Set C will focus on both A and B.
15854166|NCT04009187|Behavioral|30-minute education session|Both groups will receive a 30-minute education session regarding the CPGs. This education session will follow the instructions provided in Rice and colleagues. (L. A. Rice et al., 2014). It consists of the importance of practicing biomechanical efficient propulsion. The material lists out the consequences and the impact of upper limb pain and injury. It provides a detailed step by step on how to propel properly. They will view the video that shows the biomechanics of efficient and inefficient propulsion.
15854167|NCT04009174|Other|Imaging Panel|"Initial Protocol (REB approval date 08-Sept-2011)
~Pre-operative Imaging Panel
~[18F]-FCH PET + Dynamic CT
~MRI of the pelvis with endorectal coil (T1, T2, DW, DCE, MRS)
~3D-Transrectal ultrasound
~Optional PET/MRI (added with Protocol Amend 1, REB approval date 22-Aug-2012)
~Optional Sodium (23Na) MRI (added with Protocol Amend 2, REB approval date 25-Feb-2013)
~Protocol Amendment #3, REB approval date 20-Oct-2015:
~Pre-operative Imaging Panel
~[18-F]-DCFPyL PET+Dynamic CT
~PET/MRI with endorectal coil
~3D-Transrectal Ultrasound
~Optional Sodium (23Na) MRI"
15854168|NCT04009161|Procedure|Tooth extraction|Tooth extraction before the beginning of radiotherapy in patients irradiated for Head and Neck cancer
15854169|NCT04009148|Other|CASCADE genetic screening|Family-based cohort of mutation carriers, blood relatives who test negative, and untested blood relatives
15854209|NCT04008914|Other|retrospective observation|Retrospective review of study patients excluded from the CONNECT- HF trial who were discharged with a diagnosis of HFpEF between August 1, 2017 and March 1, 2018. Readmission rate at 30 and 90 days along with patient demographics and associated comorbidities were analyzed.
15854170|NCT04009135|Behavioral|internet delivered cognitive behavioural therapy (iCBT)|The intervention comprises 7 weekly online modules available through Therapist Assisted Online (TAO), including: 1) psychoeducation about chronic pain and depression; 2) thoughts and feelings; 3) understanding stress and relaxation; 4) unhealthy and healthy thoughts; 5) layers of thinking; 6) core beliefs; and 7) relationship, lifestyle, problem solving, and relapse prevention. Online content is supplemented with weekly coaching sessions performed via video-conference with doctoral students of Clinical Psychology.
15854171|NCT04009135|Behavioral|online delivered acceptance and commitment therapy (iACT)|The intervention comprises 7 weekly online modules available through Therapist Assisted Online (TAO), including: 1) psychoeducation about chronic pain and depression; 2) introduction to ACT; 3) cognitive fusion and defusion; 4) thinking mind versus observing mind & acceptance; 5) mindfulness; 6) values; and 7) taking action. Online content is supplemented with weekly coaching sessions performed via video-conference with doctoral students of Clinical Psychology.
15854172|NCT04009135|Other|Attention Control (AC)|1-module of psychoeducation about chronic pain and major depression. Weekly contact to complete measures of symptomatology and well-being.
15854173|NCT04009122|Dietary Supplement|IGEN0206|Group A
15854174|NCT04009122|Other|Placebo|Group B
15854175|NCT04009109|Drug|Lenalidomide|Induction and Maintenance
15854176|NCT04009109|Drug|Ixazomib|Induction and Only Maintenance Arm B
15854177|NCT04009109|Drug|Daratumumab Injection|Induction and Only Maintenance Arm B
15854178|NCT04009109|Drug|Dexamethasone|Induction and Only Maintenance Arm B
15854179|NCT04009096|Biological|ChAd63 PvDBP and MVA PvDBP|one dose of 5 x 10^10 vp ChAd63 PvDBP and one dose of 2 x 10^8 pfu MVA PvDBP 8 weeks later, in a heterologous prime-boost regimen.
15854180|NCT04009083|Device|Standard of Care MRI|Prostate MRI, serum Prostate Specific Antigen (PSA), in field and random systemic prostate biopsies
15854181|NCT04009083|Other|Fluciclovine PET scan added to MRI|18F-Fluciclovine (Axumin) is a radioactive diagnostic agent indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate specific antigen (PSA) levels following prior treatment
15854182|NCT04009070|Device|Acupuncture Pres Needle: 0.22x1.5 mm needle|Acupunctur group; Acupunctur preoperatively 24 hours before bilateral PC6 (approximately two cm above the midline of the wrist line) and ST 36 (approximately 1-2 cm laterally from the tuberocyte tibia). The tape (Needle Press) will remain for 24 hours after surgery.
15854183|NCT04009057|Other|B/F/TAF|B/F/TAF administered in accordance with the approved product monograph
15854184|NCT04009044|Drug|Afimoxifene|Apply topically
15854185|NCT04009044|Procedure|Core Biopsy|Undergo core needle biopsy
15854186|NCT04009044|Other|Questionnaire Administration|Ancillary studies
15854187|NCT04009031|Device|Bootle Blast|During the baseline assessment, an occupational therapist will calibrate the video game to the child's therapy needs and functional abilities. Within a week of the first assessment, the research team will set up the video game in the participant's home where it will remain for 12 weeks. Training on how to play the game and a user manual will be provided. The researcher will work with each family to establish a play objective (minutes/day and days/week) that considers the family's schedule. Five-minute telephone check-in calls will be done weekly.
15854188|NCT04009018|Other|Perioperative Satisfaction Scale in Regional Anesthesia|This study is methodological research. Perioperative Satisfaction Scale in Regional Anesthesia will be used to collect data.
15854189|NCT04009005|Behavioral|Therapeutic diet and lifestyle|Educational videos, 4 individual support calls and monthly support group meetings conducted via an internet based audio/ video conference platform. Patients will be trained on a low lectin modified paleolithic diet; breathing meditation practice, and body weight strengthening
15854190|NCT04008992|Drug|BMS-986259|Single and Multiple ascending dose from Dose 1 to Dose 5
15854191|NCT04008992|Other|Placebo|Placebo matching BMS-986259
15854192|NCT04008992|Diagnostic Test|P-Aminohippurate|Diagnostic Agent
15854193|NCT04008992|Diagnostic Test|Iohexol|Diagnostic Agent
15854194|NCT04008979|Drug|Aspirin|Aspirin - lipid complex
15854195|NCT04008966|Drug|combined oral contaraceptive pills|1 tablet daily between days 5 and 25 of the cycle before stimulation
15854196|NCT04008966|Drug|recombinant FSH|300 U from the 2nd day of the cycle then the dose was adjusted according to the ovarian response evaluated by transvaginal ultrasound and serum E2
15854197|NCT04008966|Drug|Urinaru gonadotropin|150 U from the 2nd day of the cycle then the dose was adjusted according to the ovarian response evaluated by transvaginal ultrasound and serum E2
15854198|NCT04008966|Drug|GnRH antagonist|0.25 subcutaneously daily from the day in which the leading follicles reached 12 mm till the day of triggering
15854199|NCT04008966|Drug|Human chorionic gonadotropin|10,000 IU intramuscular when at least 3 follicles larger than 14 mm and at least one of them reached a mean diameter of 17 mm or more
15854200|NCT04008966|Drug|GnRH agonist|0.2 mg subcutaneously when at least 3 follicles larger than 14 mm and at least one of them reached a mean diameter of 17 mm or more
15854201|NCT04008966|Procedure|Ovum pick up|34 hours after triggering under the guidance of transvaginal ultrasound
15854202|NCT04008966|Procedure|Embryo transfer|Transabdominal ultrasound guided embryo transfer was done 3 days after oocyte retrieval using Labotect semirigid catheter
15854203|NCT04008966|Drug|natural Progesterone|400 mg twice daily per vagina
15854204|NCT04008953|Device|ultrasonography|Intravascular volume assessment using ultrasonography, CVP and echocardiography
15854205|NCT04008940|Device|Distal femur plates|By assessing the rate and mode of mechanical failures we aim to identify risk factors for mechanical failures among the analysed plate types. This, finally, is depending on the overall number of cases and number of failure cases.
15854206|NCT04008927|Diagnostic Test|HCV screening|All patients will have HCV screening using rapid tests. HIV and HBV testing will also be conducted and patients will be appropriately referred to appropriate health services.
15854207|NCT04008927|Diagnostic Test|Diagnosis of hepatitis C|HCV-RNA assay (GeneXpert, Cepheid) will be performed for all participants with positive HCV serology to determine if patients have chronic hepatitis C (defined by HCV-RNA>10 UI/mL). In addition a measure of the liver stiffness will be performed.
15854208|NCT04008927|Drug|HCV treatment|Direct-Acting Antiviral drugs will be prescribed for 8 or 12 weeks according to liver assessment.
15854210|NCT04008901|Drug|BST-104 (Lonicera Flos Extract)|175 mg of Lonicera Flos extract in 1 tablet (300 mg)
15854211|NCT04008901|Drug|Placebo oral tablet|0 mg of Lonicera Flos extract in 1 tablet (300 mg)
15854212|NCT04008888|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Allogeneic Stem Cell Transplant: Day 0 Infusion of allogeneic peripheral blood stem cells. For the allogeneic matched-related donors peripheral blood stem cells will be harvested with GCSF mobilization and infused fresh to the recipients.
15854213|NCT04008888|Procedure|Autologous Hematopoietic Stem Cell Transplantation x 1 or x 2|Autologous hematopoietic stem cell transplantation :Stem cell mobilization with granulocyte colony-stimulating factor (GCSF) at a dose of 10 μg/kg/day followed collecting CD34+ peripheral blood stem cells . Day 0 Infusion of autologous stem cells. Patients during 3-6 months after the 1st SCT will undergo a 2nd SCT. Patients who had not enough PBSC will undergo a 1st SCT.
15854214|NCT04008888|Drug|Melphalan Given IV|conditioning regimen: autologous ARM: Day -2 Melphalan 200 mg/m^2/day IV over 30 minutes. allogeneic ARM: Day -4, Day -3 Melphalan 70 mg/m^2/day IV over 30 minutes
15854215|NCT04008888|Drug|Fludarabine Injection|conditioning regimen:Days -6,-5,-4,-3 Fludarabine 30 mg/m^2/day IV
15854216|NCT04008888|Drug|PI and dexamethasone as maintenance therapy|Bortezomib and dexamethasone(VD),Ixazomib and dexamethasone(ID)
15854217|NCT04008888|Drug|PI+IMids+Dexamethasone as Consolidated Chemotherapy|Oral lenalidomide at the starting dose of 25mg on days 1-21 every 28 days or days 1-14 every 21 days. Dexamethasone at 20mg twice weekly on days 1,2,4,5,8,9,11&12 of each 21-day.
15854218|NCT04008862|Behavioral|Partnership-based nursing practice|Provided by clinical nurse specialists (n=2) and specialized nurses (n=3): i) Partnership-based theoretical nursing practice framework: Family involvement, living with symptoms and access to healthcare -primary goal of enhancement of the health experience. Key question: What are your main concerns about the health of the person with the lung disease? Followed by conversations: a) Existence of lung disease and symptoms that the patient has. b) Nature of disease, its management, quitting smoking, use of inhaler medications, utilization of health care, negative feelings and issues. Skills and motivation to undertake activities to maintain and improve well-being, skills in communication with family, relatives and health professionals. ii) Empirical knowledge about the nature of COPD, symptom management and palliative care and the GOLD clinical guidelines. iii) Patients are seen over an undefined time period in the out-patient clinic or at home depending on needs and capabilities.
15854219|NCT04008849|Other|Safety and efficacy assessments|Long term safety and clinical outcomes
15854220|NCT04008823|Other|Retrospective and observational epidemiological study, by review of clinical histories,|Retrospective and observational epidemiological study, by review of clinical histories,
15854221|NCT04008797|Drug|E7386|E7386, tablets, orally.
15854222|NCT04008797|Drug|Lenvatinib|Lenvatinib, capsules, orally.
15854223|NCT04008784|Drug|Crisaborole 2% Topical Application Ointment [EUCRISA]|Ointment
15854224|NCT04008784|Drug|Triamcinolone Acetonide 0.1% Ointment|Topical Corticosteroid
15854225|NCT04008771|Device|SeeQ CdSe 655 ALT|SeeQ CdSe 655 Alt is a sterile colloidal solution of coated CdSe nanoparticles in a borate buffer suitable for intraocular injection.
15854226|NCT04008758|Diagnostic Test|Ultrasound|Evaluate participant's lung condition using ultrasound. Using lung ultrasound scoring, more than 1 point needs recruitment maneuver
15854227|NCT04008745|Other|Educational and home-based physical therapy by foot-related exercises|The booklet is divided in 2: educational and exercise protocol. The aim of the first part is to guide the individual for a change in his/her health behavior, and comprises info about diabetic neuropathy, foot care, shoes, and benefits of exercising. The second part is the foot protocol, composed by 6 exercises. The maximum duration of a session is 20min and should be performed 3 times/week. The subject should warm-up the foot-ankle and then start exercising in the order suggested by the booklet, filling a table with the effort perceived (effort likert scale). The foot exercises progresses from one set with 30 repetitions in a sitting position, to exercising standing, then performing the exercise on one foot only. Other progression criterion is to increase the number of sets performed. The effort scale regulates the individual effort for his/her progression, which is also registered by the participant in the monthly table at the booklet.
15854228|NCT04008732|Drug|MED2005|(Day -1 to Day 1): Subjects will undergo six treatment periods, each separated by at least a two day washout. Each treatment period will be approximately 1 day in duration from the afternoon of Day -1 to the afternoon of Day 1 at 6 hours (h) post-dose. In each of the treatment periods, the subject will receive one of the six administrations over 6 treatment periods (1/period) and will return approximately two days later for the next treatment period.
15854229|NCT04008732|Drug|Nitrostat 0.6Mg Sublingual Tablet|Active comparator to be used for Part 1 of the study. Nitrostat will be dosed in two treatment periods and 3 x 0.6 mg tablets will be required to make up the 1.8 mg dose.
15854230|NCT04008732|Drug|Nitro Pohl|to be dosed intravenously in Part 2 of the study
15854231|NCT04008719|Other|Thymic history|This interview concerns mainly the nature of the previous psychiatric and psychological care
15854232|NCT04008719|Other|Evaluation of the psychiatric disorders|Mini International Neuropsychiatric Interview for the positive diagnosis of depression - under the MINI score of depression.
15854233|NCT04008719|Other|Cognitive evaluation|They will be held consecutively to the patient's bedside interview on the same day. Some tests will be computerized, others will be in paper form.
15854234|NCT04008706|Drug|Acalabrutinib|Acalabrutinib will be administered as one 100 mg capsule taken orally, twice daily with 8 ounces (approximately 240 mL) of water.
15854235|NCT04008693|Dietary Supplement|Aged Garlic Extract|2.400 mg (four capsules) of a nutritional supplement of aged garlic extract (Kyolic® Hi-Po Formula - Kyolic)
15854236|NCT04008693|Other|Placebo|800 mg of maltodextrin (four capsules)
15854237|NCT04008680|Other|EQ-5D-5L survey internal consistency|To see how increasing the number of questionnaires affects the internal consistency of the EQ-5D-5L.
15854238|NCT04008667|Other|Acupoint application|Acupoint application: The patients start using the acupoint application on the umbilical Shenque point in 2 hours after surgery, 1 or 2 times a day, lasting 5 days.
15854239|NCT04008667|Other|Fake acupoint application|Fake acupoint application: The patients start using the fake acupoint application on the umbilical Shenque point in 2 hours after surgery, 1 or 2 times a day, lasting 5 days.
15854377|NCT04007406|Drug|DP13|DP13 systemic administration
15854240|NCT04008654|Behavioral|ERAS Protocol|"Preoperative measures:
~Counseling before hospital admission Fluid, and carbohydrate loading Avoiding prolongation of the fasting period Avoiding bowel preparation or its application only in selective cases Application of antibiotic prophylaxis Application of thromboprophylaxis Avoiding premedication
~Intraoperative measures:
~Use of short-acting anesthetic agents Application of midthoracic, epidural anesthesia/analgesia Refraining from using drains Refraining from salt, and water overload Maintenance of normothermia (heating the body, and use of warmed up intravenous fluids)
~Postoperative:
~Application of midthoracic, epidural anesthesia/analgesia Refraining from use of nasogastric tube Prevention of nausea, and vomiting Refraining from salt, and water overload Earlier removal of catheters Initiation of oral intake at an early period Use of nonopioid oral analgesics/NSAIDs Early mobilization Adherence to the protocol, and auditing results"
15854241|NCT04008654|Behavioral|Conventional care|This group of patients will not receive the specific ERAS protocol but will receive conventional care.
15854242|NCT04008641|Other|Pediatric consultation's survey|Realization of a pediatric consultation. At the end, evaluation of comprehension and psychological impact with a survey (completed by parents).
15854243|NCT04008628|Drug|Nitrous Oxide|Inhalation of a 50%/50% nitrous oxide/oxygen mixture (Kalinox®)
15854244|NCT04008615|Other|2 times : 6-minute stepper test with cardiorespiratory parameters and gaz exchange monitoring (with a rest of 20min between each test).|"For the 6-minute stepper test, please refer to NCT02842463 and NCT04004689. Gaz exchange analyzer will be calibrate before every test. Data will be recorded breath by breath.
~Heart rate will be monitored using a 12-lead electrocardiogram. Transcutaneous oxygen saturation will be assessed using a pulse oxymetry system at the earlobe."
15854245|NCT04008602|Device|Quick icing|Brief Application of cold, for a period of up to 30 seconds on a body surface which seeks to promote the activation of the nervous system to produce increased excitability.
15854246|NCT04008602|Device|Prolonged Cold|Prolonged application of cold, for at least 5 minutes or more, on a body surface that aims to reduce nervous system activation by reducing the decreased nerve conduction velocity.
15854247|NCT04008589|Device|repetitive transorbital AC Stimulation|Repetitive transorbital ACS with max 30 Hz, 1,5 mA for 10 days, 20 min/day
15854248|NCT04008589|Device|combination of transcranial direct current stimulaton and rtACS|Sequential tDCS (anodal occipital stimulation with 2 mA for 20 min/day for 10 days) and rtACS
15854250|NCT04008563|Procedure|Bariatric Surgery|Patients who are randomized to the intervention group will receive a progestin intrauterine device and be referred for bariatric service to undergo bariatric surgery within 3 months of their study consent.
15854251|NCT04008550|Procedure|Right Heart Catheterization|A right heart catheterization will be done in patients with PAH before TAVI (3 months after TAVI)
15854253|NCT04008524|Biological|CAR-T cells|Chimeric Antigen Receptor-T cells
15854254|NCT04008511|Drug|Regorafenib|Phase Ib Group A: Regorafenib 120mg + XELOX; Group B: Regorafenib 160mg + XELOX; Group C: Regorafenib 80mg + XELOX.
15854255|NCT04008511|Drug|Regorafenib|Phase II: Regorafenib MAD qd po for 14 days, every 3 weeks.
15854256|NCT04008511|Drug|Capecitabine|Capecitabine 1000 mg/m2 bid po for 14 days.
15854257|NCT04008511|Drug|Oxaliplatin|Oxaliplatin 130mg/m2, day 1, every 3 weeks
15854258|NCT04008498|Diagnostic Test|AEEG brain monitoring|"Babies will be recorded continuously for the entire duration of their time on the intensive care unit.
~Once the child is receiving high dependency or special care, we will record aEEG for 4 hours once a week until the baby is discharged home. If a participant is moved back to intensive care, the aEEG will be started again if the aEEG monitor is not being used on another baby."
15854259|NCT04008485|Device|Magnetic Electric Impedance Spectroscopy Device to predict PTB|During this phase, we will measure MIS in 100 women at high risk of PTB (Group 1) and 100 women with symptoms of PTB to confirm its predictive potential for PTB. To determine whether MIS assessment could prove a platform technique for other tests and treatments within existing antenatal care pathways for PTB, we will also assess vaginal swabs for fFN and measure cervical length (CL) by ultrasound.
15854260|NCT04008472|Other|Telemedecine|Initiation of tele-medical consultation with the resident, a caregiver for the nursing home, the referring physician and geriatrician téléexpert. After a overall geriatric assessment in nursing homes by UPSAV the first teleconsultation is organized within 10 days. Subsequent visits are scheduled every 3 months for 12 months. Spontaneous visits can be requested at the initiative of the referring physician.
15854261|NCT04008459|Other|Therapeutic exercise class|Physiotherapy exercise class includes education, stretching, strengthening, posture and balance interventions.
15854262|NCT04008433|Drug|Lidocaine|Advanced intravenous injection of lidocaine before the propofol injection
15854263|NCT04008420|Other|monitoring of the oxygen reserve index|The investigators will enroll adult patients who will undergo robotic esophagectomy under general anesthesia. The oxygen reserve index will be monitored continuously during anesthesia. The postoperative complications will be recorded after surgery.
15854264|NCT04008407|Procedure|Endoscopic Submucosal Dissection|Endoscopic Submucosal Dissection (ESD) results in en-bloc resection of LSL, regardless of lesion size. This allows for accurate histopathological assessment of SMIC, R0/R1 resection and depth of invasion. ESD is considered a potentially curative for superficial cancers (T1a).
15854452|NCT04006821|Drug|Apatinib mesylate|Apatinib mesylate will be administered 250mg or 500mg (according to the patient's tolerance), qd, oral, until disease progression.
15854265|NCT04008407|Procedure|Endoscopic Mucosal Resection|EMR is the current standard for treating colonic LSL and has been validated to be safe and efficacious. LSLs => 20mm are frequently resected piecemeal. Recent research show that resection margin soft coagulation reduces recurrence rates to those similar to en-bloc resections.
15854266|NCT04008394|Genetic|Anti-CD30 CAR T cells|Patients receive CD30 CAR-T cells transduced with a lentiviral vector on day 0 in the absence of disease progression or unacceptable toxicity. Autologous 3th generation anti-CD30 CAR T cells.
15854267|NCT04008381|Biological|Ex-vivo Expanded γδ T Lymphocytes|Patients receive ex-vivo expanded γδ T Lymphocytes (Dose escalation, 2*10^6, 4*10^6, 8*10^6 of cells per kg of body weight).
15854268|NCT04008368|Device|CliniMACS CD34 Reagent|Haploidentical recipients will receive CD34-selected cells using Miltenyi CliniMACS CD34+ cell selection kits. The target CD34+ cell dose is at least 10 x 106/kg, and the minimum CD34+ cell dose is 5 x 106/kg. All of the cells collected during the apheresis procedure will be given. The cells will be cryopreserved and stored until the day of transplant.
15854269|NCT04008355|Drug|AZP2006 oral solution|Once daily intake in the morning
15854270|NCT04008355|Drug|Placebo oral solution|Once daily intake in the morning
15854271|NCT04008342|Other|Multisensory intervention|The intervention group (IG) was submitted to 16 individual multisensory stimulation sessions that followed the protocol. In each session, at least two senses are stimulated in a safe, quiet and confidential environment. The sessions lasted 30 minutes and were conducted twice a week, on the same day and time whenever possible. Nonetheless, the session could be interrupted when the participant wished or if the therapist observed that the patient was uncomfortable. A nondirective approach and one-to-one intervention were adopted.
15854272|NCT04008316|Drug|Colchicine|colchicine 1mg/day
15854273|NCT04008303|Procedure|Migraine surgery|Surgical decompression of neuromuscular structures causing migraine headaches.
15854274|NCT04008290|Drug|0.6 mg Liraglutide|For a duration of 5 consecutive days, subjects will receive a subcutaneous injection in the abdomen of 0.6 mg liraglutide. The injection will be placed by a trained nurse at 8 o'clock every morning. A wash out period of at least one week will be respected between the two treatment weeks.
15854275|NCT04008290|Drug|Placebo|For a duration of 5 consecutive days, subjects will receive a subcutaneous injection in the abdomen of placebo (0.9% saline solution). The injection will be placed by a trained nurse at 8 o'clock every morning. A wash out period of at least one week will be respected between the two treatment weeks.
15854276|NCT04008264|Drug|Scopolamine Patch (Transderm V)|During the observational phase, patients will be given a prescription for an 18 day supply of scopolamine, and patients will record the same data as prior to the intervention.
15854277|NCT04008251|Genetic|Second generation humanized CAR-T cells|Patients receive humanized CD19 CAR-T cells transduced with a lentiviral vector on days 0/1/2 in the absence of disease progression or unacceptable toxicity.
15854278|NCT04008238|Drug|Trabectedin|- Trabectedin will be prescribed as per market authorization and will be administered by intraveinous infusion (1,5 mg/m²) every 3 weeks. A treatment cycle is defined as a 3-weeks period
15854279|NCT04008225|Procedure|Bronchoalveolar lavage|
15854280|NCT04008212|Other|Fusion imaging|Fusion imaging during aortic endovascular procedures with a mobile C-arm through the use of the EndoNaut® angio-navigation station
15854281|NCT04008199|Other|Super Abbu|The investigators have developed, piloted, and propose to expand and to experimentally evaluate a speech-based service that connects expectant fathers to doctors and to each other over a simple phone call. This service is dubbed Super Abbu (Super Dad in English).
15854282|NCT04008186|Drug|Omaveloxolone|50 mg capsules
15854283|NCT04008186|Drug|Midazolam oral solution|2 mg/mL oral solution
15854284|NCT04008186|Drug|Repaglinide 1 MG|1 mg tablet
15854285|NCT04008186|Drug|MetFORMIN 500 Mg Oral Tablet|500 mg tablet
15854286|NCT04008186|Drug|Rosuvastatin|10 mg tablet
15854287|NCT04008186|Drug|Digoxin tablet|0.25 mg tablet
15854288|NCT04008186|Drug|Gemfibrozil Tablets|600 mg tablet
15854289|NCT04008186|Drug|Itraconazole capsule|100 mg capsule
15854290|NCT04008186|Drug|Verapamil Pill|120 mg tablet
15854291|NCT04008173|Other|Non-interventional patient registry|Non-interventional patient registry
15854292|NCT04008160|Device|ProTex|Non invasive measurement of pressure, temperature, humidity, perfusion, and oxygenation
15854293|NCT04008147|Drug|100mg iron sulfate|100mg iron sulfate b.i.d. for 4 consecutive days
15854294|NCT04008134|Behavioral|CHoBI7 health facility program|The CHoBI7 health facility program focuses on promoting handwashing with soap and water treatment to diarrhea patients and their household members during the one-week period after the patient is admitted to the health facility, when their household is at highest risk for diarrheal diseases. The CHoBI7 program includes: (1) a WASH pictorial module delivered by a health worker bedside to diarrhea patient and their household members in a health facility on handwashing with soap, water treatment, and safe water storage; and (2) a diarrhea prevention package containing chlorine tablets for water treatment, a soapy water bottle (water and detergent powder), a handwashing station, and a water vessel with a lid and tap for safe drinking water storage. Households are instructed to boil their water once their supply of chlorine tablets is completed.
15854295|NCT04008134|Behavioral|CHoBI7 mHealth program|The CHoBI7 mHealth (mobile health) program targets five key behaviors: (1) preparing soapy water using water and detergent powder; (2) handwashing with soap at food and stool related events; (3) treating household drinking water using chlorine tablets during the one week high risk period after the diarrhea patient in the household was admitted to the health facility; (4) safe drinking water storage in a water vessel with a lid and tap; and (5) heating of household drinking water until it reaches a rolling boil after the one week high risk period. Participant households receive bi-weekly voice and text messages from the CHoBI7 mHealth program over a 12-month period. These mobile messages are sent using the VIAMO platform (www.viamo.io).
15854296|NCT04008134|Behavioral|CHoBI7 home visit program|The CHoBI7 home visit program involves two, 30-minute home visits conducted during the week after the index diarrhea patient was recruited at the health facility. A health worker reinforces the content of the CHoBI7 health facility program in the participant's home.
15854297|NCT04008121|Combination Product|Fluorescein sodium and Zeiss FF450 fundus camera|Fluorescein sodium administered as a bolus intravenous injection; Zeiss FF450 fundus camera used for imaging of the eye of all participants
15854298|NCT04008121|Combination Product|MB-102 and Zeiss FF450 fundus camera|MB-102 administered 3 days after fluorescein sodium as a bolus intravenous injection; Zeiss FF450 fundus camera used for imaging of the eye of all participants
15854299|NCT04008121|Combination Product|Fluorescein sodium and commercially available optical angiography imaging system|Following Zeiss FF450 imaging, one of two systems (Heidelberg Spectralis or Optos California or 200Tx) will be used for imaging of the eye in a subset of participants
15854300|NCT04008121|Combination Product|MB-102 and commercially available optical angiography imaging system|Following Zeiss FF450 imaging, one of two systems (Heidelberg Spectralis or Optos California or 200Tx) will be used for imaging of the eye in a subset of participants
15854301|NCT04008108|Other|Activity sensor|Activity sensor worn on the wrist during 7 days, 24h/24 to evaluate physical activity of patient (measured by the number of step per day) before and after Artificial Urinary Sphincter Implantation.
15854302|NCT04008082|Drug|Lenvatinib|Lenvatinib capsule.
15854303|NCT04008069|Drug|Sarilumab 200 MG/1.14 ML Subcutaneous Solution [KEVZARA]_#1|Sarilumab vs Placebo
15854304|NCT04008069|Drug|Placebos|Placebo
15854305|NCT04008056|Other|Patient Reported Outcome questionnaire|34 question form to assess patient symptoms
15854306|NCT04008043|Drug|Vicodin|In addition to taking one tablet of vicodin for pain every 4-6 hours up to 8 tablets, pain scores will be recorded the evening of the surgery, the day after the surgery and one week after the surgery.
15854307|NCT04008043|Drug|Dexamethasone|In addition to taking one tablet of dexamethasone for pain beginning the day before surgery and on the day of surgery, pain scores will be recorded the evening of the surgery, the day after the surgery and one week after the surgery.
15854308|NCT04008030|Biological|Ipilimumab|Specified dose on specified days
15854309|NCT04008030|Drug|Oxaliplatin|Specified dose on specified days
15854310|NCT04008030|Drug|Leucovorin|Specified dose on specified days
15854311|NCT04008030|Drug|Fluorouracil|Specified dose on specified days
15854312|NCT04008030|Drug|Irinotecan|Specified dose on specified days
15854313|NCT04008030|Drug|Bevacizumab|Specified dose on specified days
15854314|NCT04008030|Drug|Cetuximab|Specified dose on specified days
15854315|NCT04008030|Biological|Nivolumab|Specified dose on specified days
15854316|NCT04008017|Diagnostic Test|Eosinophilic Cationic Protein biomarker|3 ml blood for serum sample for estimation of Eosinophilic Cationic Protein biomarker level using ELISA
15854317|NCT04008004|Drug|EDP-514|Oral Capsule; Subjects will receive either a single dose of EDP-514 on Day 1 only (SAD HV), once daily dosing of EDP-514 starting on Day 1 through Day 14 (MAD HV) or once daily dosing of EDP-514 starting on Day 1 through Day 28 (MAD HBV).
15854318|NCT04008004|Drug|Placebo|Placebo to match EDP-514
15854319|NCT04007991|Drug|Ecopipam|Ecopipam tablets administered PO to establish 2 mg/kg/day; Matching Placebo
15854320|NCT04007978|Genetic|Third generation CAR-T cells|Patients receive CD22 CAR-T cells transduced with a lentiviral vector on day 0 in the absence of disease progression or unacceptable toxicity.
15854321|NCT04007965|Procedure|Pneumatic Posterior Capsulorhexis|Pneumatic Posterior Capsulorhexis using air dose 0.1 ml and Healon dose 0.5 -1.0 ml.
15854322|NCT04007952|Procedure|Anterior Gastropexy|Two permanent sutures will be introduced into the abdomen and placed along the lesser curvature of the stomach. A suture passer will be used to grasp the ends of the sutures to externalize them at separate fascial punctures. At time of abdominal desufflation, the sutures will be tied and the incision closed per individual surgeon practice.
15854323|NCT04007926|Behavioral|Aerobic exercise programme|Participants will start with 3 x 20 minute exercise sessions in the first week, building up to 5 x 60 minutes of exercise by weeks 9-12 of the intervention, at an intensity of 65-80% of predicted maximum heart rate.
15854324|NCT04007926|Behavioral|Resistance exercise programme|Participants will undertake two supervised sessions per week. The exercises performed during each session will consist of leg press, calf press, leg extension, leg curl, chest press, shoulder press, lateral pull down and seated row. Exercises will be performed at 60-80% 1RM. In weeks 1-2 participants will perform, during each session, a single set of 5-10 repetitions of each exercise (tiring but comfortably achievable) to ensure they are comfortable with the exercises and are performing these in the correct form. In weeks 3-4 participants will perform, during each session, two sets of each exercise to voluntary muscular failure - defined as not being able to perform single another repetition. In weeks 5-12 this will progress to 3 sets of each exercise to voluntary muscular failure, in each session.
15854325|NCT04007913|Behavioral|teleCBIT|Eight sessions of individual behavior therapy
15854326|NCT04007900|Behavioral|Positive Affect Treatment|PAT was designed as a 15-week intervention delivered in 3 modules. Module 1 (Pleasant Events Scheduling) uses behavioral activation methods to enhance positive experiencing before, during, and after rewarding events. Module 2 (Attending to the Positive) applies cognitive training techniques to promote shifting attention towards rewarding aspects of daily situations and to learn behavior mood associations. Module 3 (Cultivating the Positive) uses mindfulness approaches to foster reward experiencing. Treatment length has been expanded to 20 sessions to enhance the suitability of the intervention for AN and target the reward mechanisms that characterize AN. Additional adaptations include: 1) An emphasis on a mindful balance between reward and inhibition; 2) Additional module on shifting attention away from AN-specific rewards; 3) Addition of exercises to work towards long-term life goals and enhance healthy experiences; and 4) Further focus on navigating social rewards.
15854327|NCT04007887|Other|Adult education program|A 10-hour program embodying major adult education principles, designed to achieve cognitive involvement of patients in their treatment
15854328|NCT04007874|Drug|Ethinylestradiol/levonorgestrel|Ethinylestradiol/levonorgestrel 30/150 µg oral tablets once daily without a stopweek for 3 months
15854329|NCT04007874|Drug|Vitamin E|Vitamin E 400 IU oral capsules once daily for 3 months
15854330|NCT04007848|Drug|Cobimetinib|Cobimetinib will be given at the dose of 40 milligrams once a day (21 days/28). Cobimetinib is available as 20 milligrams film-coated tablets
15854331|NCT04007848|Drug|Placebo oral tablet|Placebo will be given at the dose of 40 milligrams once a day (21 days/28). Placebo is available as 20 milligrams film-coated tablets
15854332|NCT04007835|Drug|Anlotinib Hydrochloride|anlotinib (12 mg orally daily for 14 days every 21 days cycle) combined with one of EGFR-TKIs
15857496|NCT03982381|Drug|Dapagliflozin 10 MG|Experimental treatment
15854333|NCT04007822|Behavioral|Pain Navigator Tool|The Pain Navigator Tool (PNT) was developed recently with the aim to empower patients through helping them to discuss their main concerns about pain, and to help therapists to prioritise addressing these concerns (Blomkvist et al., 2018). The initial pilot study with this tool improved the content of the consultations and patient engagement, and led to better patient-therapist interaction in a small population of healthcare providers and patients (Blomkvist et al., 2018). As it endeavours to facilitate the implementation of self-management in patients with chronic pain, the PNT aligns with the Scottish Intercollegiate Guidelines Network (SIGN) guideline for chronic pain and the Scottish Government's strategic vision (Scottish Government, 2011; SIGN, 2013).
15854334|NCT04007809|Other|Glucagon|Every patients will undergo stimulated C peptide test. Glucagon will be administered using intravenous route (0,03 mg/kg, max 1mg).
15854335|NCT04007796|Behavioral|Apnea and Insomnia Relief (AIR)|This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. The main components of the AIR protocol are (a) psychoeducation, (b) motivational interviewing, (c) PAP adherence strategies, and (d) cognitive behavioral therapy for insomnia.
15854336|NCT04007796|Behavioral|Sleep Education (SE)|This treatment will be offered over six sessions. All appointments will be conducted via telehealth and will last 60 minutes. Topics covered include the sleep cycle, sleep across the lifespan, sleep and the mind, evening activities and the sleep environment, and daytime activities and sleep.
15854337|NCT04007770|Other|Acupuncture|10 treatments of acupuncture over the course of 10 weeks with a +/- 7 day window
15854338|NCT04007770|Other|Sham Acupuncture|10 treatments of sham acupuncture over the course of 10 weeks with a +/- 7 day window. After the 16-week study concludes patients in this group will have the option of receiving up to 10 sessions of real acupuncture; however, these sessions must be completed within 6 months of study conclusion.
15854339|NCT04007770|Other|16 week waiting period + optional Acupuncture|Optional real acupuncture after 16 weeks waiting period. This arm is Closed to accrual.
15854340|NCT04007744|Biological|Pembrolizumab|Given IV
15854341|NCT04007744|Drug|Sonidegib|Given PO
15854342|NCT04007731|Dietary Supplement|DrRip - high protein, high fibre and creatine load|A protein bar or control bar consumption after training every day for 5 days, 5 days wash-out, 5 days second bar consumption
15854343|NCT04007731|Dietary Supplement|Voltage energy bar|A protein bar or control bar consumption after training every day for 5 days, 5 days wash-out, 5 days second bar consumption
15854344|NCT04007718|Behavioral|Interpretation bias training|Active: 50% positive endings to scenarios, 50% generation of positive endings to ambiguous scenarios Control: 100% ambiguous endings to scenarios with no instructions to imagine positive endings
15854345|NCT04007705|Behavioral|Anti-inflammatory and low FODMAPs diet|Exemption of the intake of potentially inflammatory foods, namely gluten, dairy and processed foods, over a consecutive period of 3 months. During the first month, a low FODMAPs diet will be implemented, along with the anti-inflammatory diet, followed by the reintroduction of all fruits and vegetables over a consecutive period of 2 months.
15854346|NCT04007705|Behavioral|General healthy eating|Healthy eating counseling according to the World Health Organization
15854347|NCT04007679|Other|Pain neuroscience education|Pain neuroscience education (PNE) was conducted in physical conditions similar to the university classrooms where the study was performed. The sessions were conducted as 70-minute didactic group lessons with the same content held in separate sessions for students in each class. PowerPoint (Microsoft Corp., Redmond, WA, USA) presentations prepared by the instructor were used in all sessions. Metaphors, anecdotes, graphics, and pictures were used in an attempt to convey the information and messages about pain physiology and theory more permanently and effectively. In the PNE sessions, it was explained that the nervous system can be overprotective and that in addition to the sensitivity of the central nervous system, nociceptive transmission can be affected by an individual's thoughts, beliefs, and surroundings. At the end of the session, the students were given time to ask questions, but group discussion was limited to 15 minutes due to time restrictions.
15854348|NCT04007666|Behavioral|Cognitive Processing Therapy|Cognitive Processing Therapy is an evidence-based psychotherapy for PTSD that combines education about trauma with strategies to challenge the trauma-related cognitions that are theorized to maintain PTSD symptoms.
15854349|NCT04007666|Behavioral|Control Group|Coping-focused treatment drawn from material already offered in selected facilities.
15854350|NCT04007653|Other|Observation|No intervention
15854351|NCT04007640|Radiation|MRI with additional sequences|MRI with 15 min additional sequences to validate and assess pancreatic MRI sequences
15854352|NCT04007640|Radiation|MRI|MRI with 15 min additional sequences to validate and assess pancreatic MRI sequences
15854353|NCT04007640|Procedure|Left pancreatectomy or pancreaticoduodenectomy|Histological analysis :
15854354|NCT04007640|Radiation|MRI with additional sequences|MRI with 15 min additional sequences to assess the relevance of MRI to diagnose specific pancreatic lesions in obese patients
15854355|NCT04007614|Other|Questionnaire|Fardellone questionnaire (evaluation of calcium intake) Tolerance of treatment
15854358|NCT04007588|Drug|Nivolumab|Nivolumab is a types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. Nivolumab work by stopping various molecules on cancer cells and body cells from working against the immune system's natural fight against cancer
15854359|NCT04007588|Drug|BMS-986205|BMS-986205 is a types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. BMS-986205 work by stopping various molecules on cancer cells and body cells from working against the immune system's natural fight against cancer
15854360|NCT04007588|Drug|Ipilimumab|Ipilimumab is a types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack the cancer cells. Ipilimumab work by stopping various molecules on cancer cells and body cells from working against the immune system's natural fight against cancer
15854361|NCT04007575|Diagnostic Test|Magnetic Resonance CholangioPancreatography|The imaging data will be collected from the hospital records and image archiving system of the radiology departments of the University Hospitals
15854362|NCT04007562|Drug|Hydroxychloroquine Sulfate|"The dosage and the route of administration of Hydroxychloroquine Sulfate was the same than in Lupus disease:
~Oral administration: administered in soluble form in patients under the age of 6 years old and administered in tablets in patients other the age of 6 years old with Lipin-1 deficiency.
~The soluble form was prepared at the Necker Hospital Pharmacy. Dose: 6.5 mg/kg/day (max 400 mg/day). The plasma concentration of the drug during follow-up was made, in order to follow a possible overdose."
15854363|NCT04007549|Behavioral|Brief motivational interview on tobacco/alcohol risk reduction|"The intervention is a couple brief motivational interview (CBMI) on tobacco/alcohol risk reduction, delivered in a single session and a booster session one month later.
~It is based on motivational interviewing principals (patient-centered communication, expression of empathy, develops discrepancy, deal with resistance to change, support self-efficacy and autonomy), with feedback on tobacco / alcohol consumption, information delivery and if needed referral to treatment. The intervention also specifically focuses on relational dynamics, and marital support development. This intervention will be compared with a single individual brief motivational intervention (IBMI) and a booster session one month later, only delivered to the patient; and the partner receive e-mail or postal brief advices.
~All brief interventions will be carried out by the same psychologist trained and supervised for this type of intervention."
15854364|NCT04007536|Other|No Intervention|No Intervention
15854365|NCT04007523|Behavioral|Family Support System|Family members and/or caregivers of patients will receive pagers, and alerts will provide recommendations for daily delirium screening and therapeutic activities. Protocols with associated activities will be provided to family members.
15854366|NCT04007523|Behavioral|HELP Support System|A postoperative page will be sent, on behalf of participants, to the on-call HELP staff. The page will request early evaluation and enhanced therapeutic protocols for delirium prevention.
15854367|NCT04007510|Combination Product|EPI-CAL data network|This mobile, app-based platform was designed to: 1) enable outcomes data collection from clients and family members/support person who are receiving care at an early psychosis program, 2) summarize the data visually for clients and providers on a secure web-based dashboard, and 3) allow download of de-identified data for program or research analysis.
15854368|NCT04007510|Diagnostic Test|Community DUP Assessment Tool|A tool will be developed to enable measurement of the duration of untreated psychosis (DUP) for FEP individuals based on 1) data other assessments that are typically completed during the intake process (e.g. SIPS, SCID) or 2) specific questions, prompts, a rating scale, and anchor points to enable rating of the DUP. Participants would have their DUP rated on the new tool and also complete a second assessment of DUP by research evaluators using the Symptom Onset in Schizophrenia Inventory (SOS) to determine reliability and validity of the new tool.
15854369|NCT04007484|Device|Hemoperfusion|Hemoperfusion is achieved by blood filtration with a hemoperfusion device. Specifically, the hemoperfusion device composed of multiple parallel resin cartridges is connected in parallel to the oxygenator and blood reservoir and perfused at a rate of 200-250ml/min. The purpose of hemoperfusion is to decrease inflammatory mediators produced during cardiopulmonary bypass through resin cartridges adsorption, such as cytokines, free hemoglobin and other toxins. The ultimate goal of hemoperfusion is to decrease postoperative complications, improve postoperative recovery, and eventually shorten the length of hospital stay.
15854370|NCT04007471|Other|Anonymous survey|Anonymous questionnaire to determine the prevalence of dysmenorrhea of adolescent girls, to assess the severity of dysmenorrhea, how girls experience their menses, the consequences on daily living activities or at school, and how they manage their pain.
15854371|NCT04007458|Behavioral|Letter|MaineGeneral Radiology will generate a reminder letter about their need for an annual low dose CT scan to the subjects in this arm.
15854372|NCT04007458|Behavioral|Community Health Worker Phone Call|Patients will receive a phone call from community health worker, offering to help them overcome barriers to repeat annual screening and offering to help them schedule their screening.
15854373|NCT04007445|Behavioral|Formally Directed Group (Exercise Group)|This group will receive a 12-week exercise intervention that will educate and support the person's ability to exercise. Working with a trainer, the participant will attend a 12-week (3 x week) exercise program that has been personalized to their goals. Each session will include warm-up, stretching, cardiovascular exercises, strength exercises, and cool-down. Each session will be 1-2 hours in duration. The participants may wear accelerometers and heart rate monitors to help determine the level of intensity of the exercises, as they should be performing at least 150 minutes of moderate to vigorous exercise each week. By the end of the 12-week program, the goal is for participants to guide their own exercise regimens.
15854374|NCT04007445|Other|Self-Directed Group (Control Group)|This group will receive a 1-hour education session during which they will learn about the National Council on Health, Physical Activity and Disability (NCHPAD) website, an information and resource center on health promotion for people with disabilities. During the session participants will be given an overview of the website and asked to find three resources they find of interest. Their strength and fitness will also be assessed by completing a 1-rep max test. The participants will then be asked to maintain their regular physical activity for the next 12 weeks and complete a weekly physical activity log to track their exercise participation. A staff member will phone each person every week for the 12-week period and have the participant report his or her physical activity during the week.
15854375|NCT04007432|Other|pulse oxymeter|Nocturnal oxymetry data will be continuously collected during nighttime by a pulse oxymeter, covering for 1 to 3 nights.
15854376|NCT04007419|Behavioral|Health Promoters and Organ Donation|Promotoras de Donación is a highly engaging and interactive online learning experience, that accommodates multiple learning styles by incorporating a variety of pedagogic approaches. The module consists of two components: a didactic educational component and a skills-based communication component. The didactic component provides basic information about organ donation and transplantation and the need for donors in the Hispanic community, and addresses concerns about donation commonly held by older Latina. The skills-based component provides instruction on the key communication skills needed to effectively engage small groups in discussions about organ donation. This component is intended to build communication self-efficacy or confidence opening the discussion about donation, addressing concerns raised by mature and older women participating in the small group sessions, and promoting the act of donor registration using persuasive, but non-coercive language.
15854378|NCT04007393|Behavioral|Lifestyle Modification Therapy (LSMT)|LSMT will consist of both in-person and by telephone sessions delivered throughout the entirety of the 48-week intervention phase. Each session will last 30-60 minutes. A trained study coordinator (a registered dietician or someone trained by our registered dietician) will delivery this therapy which consists of counseling using education, goal setting and barrier reduction. Topics covered will include calories, tracking, healthy food choices, reducing high fat, added sugar foods, setting goals and portions, changing the quality of your diet, volumetrics, purposeful activity, quick and easy meals, problem solving, food cues and eating patterns, emotional eating, accurate tracking, eating away from home, unhelpful thoughts, structured menus and the role of protein, social cues, managing stress, slips and relapse prevention, long-term physical activity and overcoming obstacles, high-risk situation and keys to success, motivation and looking to the future (long-term plans).
15854379|NCT04007393|Drug|Phentermine Pill|Phentermine will be started only if a participant does not lose 5% of BMI after 12 or 24 weeks of LSMT depending on their random assignment. Subjects will take 15 mg of phentermine every morning for 12 weeks at which time there will be an assessment of weight loss. Subjects who achieve 5% or more BMI reduction after 12 weeks of phentermine will continue 15 mg every morning for the remainder of the study (through week 48) along with their LSMT.
15854380|NCT04007393|Drug|Topiramate Pill|Participants who do no not achieve at least 5% BMI reduction after 12 weeks of phentermine+LSMT will be re-randomized 1:1 to either topiramate+phentermine+LSMT or topiramate+placebo+LSMT. Topiramate dosing will begin at 50 mg every morning for the first 7 days, and then increase to 100 mg every morning through week 48. At the end of week 48 the taper off will be 50 mg every morning for 7 days and then discontinue.
15854381|NCT04007380|Other|Continuous positive airway pressure (CPAP) therapy|The participants will undergo CPAP therapy for 4 consecutive months in the management of moderate-to-severe SRBDs
15854384|NCT04007354|Other|Ventilation method|Depending on the group assignment, mechanical ventilation or spontaneous breathing was performed.
15854385|NCT04007341|Drug|Dexmedetomidine|The study drug for each group was administered from the time immediately after induction of anesthesia until the end of the surgery.
15854386|NCT04007328|Drug|Methylprednisolone Sodium Succinate|methylprednisolone vial
15854387|NCT04007328|Drug|Placebo|Normal saline manufactured to mimic methylprednisolone vial
15854388|NCT04007315|Device|SaeboGlove therapy|An individualised self-management training programme involving repetitive grasping and releasing movements over 6 weeks.
15854389|NCT04007315|Behavioral|Usual care|6-weeks of usual NHS care
15854390|NCT04007302|Other|measurement of bilateral activity of the prefrontal cortex by a NIRS system (near infrared spectroscopy)|measurement of the cerebral oxygenation response by the use of the Near Infrared Spectroscopy (NIRS) method
15854391|NCT04007302|Other|completion of questionnaires|igroup presence questionnaire (IPQ), Dallas Pain Questionnaire (DRAD), Fear-Avoidance Beliefs (FABQ) and Quebec Back Lumbago Scale
15854392|NCT04007302|Other|completion of questionnaires for pain|analogical visual and numerical scale and Borg scale
15854393|NCT04007289|Drug|Apixaban|Administration of Apixaban ; 2 clinical examinations; blood tests, 3 liver and spleen stiffness measurements, 2 contrast enhanced echocardiographies, 1 hepatic ultrasonography, Biological samples collections to identify predictors of thrombosis and liver related events
15854394|NCT04007289|Drug|Placebo|Administration of placebo ; 2 clinical examinations; blood tests, 3 liver and spleen stiffness measurements, 2 contrast enhanced echocardiographies, 1 hepatic ultrasonography,
15854395|NCT04007276|Drug|brimonidine tartrate ophthalmic solution 0.025%|Single dose of brimonidine tartrate ophthalmic solution 0.025% applied as an eye drop to the eye surface.
15854396|NCT04007276|Other|sterile balanced saline solution|Single dose of sterile balanced saline solution applied as an eye drop to the eye surface.
15854397|NCT04007263|Drug|Placebo|Placebo via 30 minute infusion once daily for 5 days
15854398|NCT04007263|Drug|NP10679|NP10679 25 mg via 30 minute infusion once daily for 5 days
15854399|NCT04007250|Device|FENIX™ Continence Restoration System|"The FENIX™ Continence Restoration System is indicated for use for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative therapy. The FENIX™ System Implant is placed around the external anal sphincter to augment a weak anal sphincter and restore continence.
~The FENIX™ System is comprised of the following components:
~FENIX™ System Implant
~FENIX™ System Anal Sphincter Sizing Tool The FENIX™ System Implant consists of a series of titanium beads with magnetic cores that are connected with independent titanium wires to form an annular shape. The attractive force of the magnetic beads is designed to provide additional strength to keep a weak anal sphincter closed."
15854400|NCT04007237|Drug|shampoo with different composition|To reveal the mycological efficacy, safety, recurrence and cost-effectiveness of selenium sulfide 1.8% shampoo (SeS2) and ketoconazole 2% shampoo in the treatment of pityriasis versicolor.
15854401|NCT04007224|Drug|Intranasal oxytocin|daily administration of oxytocin, 10 UI intrnasal, 5 UI bid, and if needed curcumin orally 250 mg bid, and/or lecithin 500 mg bid, and/or pironoquinolinquinone, 20 mg qd
15854402|NCT04007224|Biological|Autologous umbilical cord blood|patients aged between 3 and 7 years will receive one-time intravenously the processed umbilical cord blood collected at the respective child's birth
15854403|NCT04007211|Device|ABT13107|Dose: 3mL, maximum 10mL
15854404|NCT04007211|Device|Hyalobarrier|Dose: 10mL
15854405|NCT04007198|Drug|EQ001|Itolizumab [Bmab 600]
15854406|NCT04007198|Drug|EQ001 Placebo|EQ001 Placebo
15854407|NCT04007185|Procedure|Maximal, safe resection of brain tumour|Standard surgical resection as part of routine care
15854408|NCT04007172|Procedure|neural therapy|Intracutaneous quaddle injections were performed using 1% lidocaine preparation as a local anesthetic for local application to painful points with palpation on the back and shoulders and for the segmental application, 2 cm lateral to the midline of the C1-T5 vertebrae and on spinous processes.
15854409|NCT04007172|Device|Physical Therapy|Physical therapy program was consist of transcutaneous electrical nerve stimulation- TENS (30-40 Hz, 20 minutes), hotpack (20 minutes) and continuous ultrasound (1mHz, 1.5w / cm2, 10 minutes) on painful points with palpation on the back and shoulders.
15854483|NCT04006535|Genetic|genetic analysis|Saliva sample collection for genetic analysis
15854410|NCT04007159|Other|Serum|Participants will be topically applied serum to the dorsum, under a semi-occlusive patch (0.02 milliliters per centimeters square [mL/cm^2] of serum in an individual cell of patch)
15854411|NCT04007159|Other|Lotion|Participants will be topically applied lotion to the dorsum, under a semi-occlusive patch (0.02mL/cm^2 of lotion in an individual cell of patch)
15854412|NCT04007159|Other|Cream|Participants will be topically applied cream to the dorsum, under a semi-occlusive patch (0.02mL/cm^2 of cream in an individual cell of patch)
15854413|NCT04007159|Other|Normal Saline|Participants will be topically applied normal saline to the dorsum, under a semi-occlusive patch (0.02mL/cm^2 of normal saline in an individual cell of patch)
15854414|NCT04007146|Diagnostic Test|Transcutaneous oxymetry measurement|Transcutaneous oxymetry measurement with transient hyperoxia period (2 periods of 30seconds at 60% of oxygen)
15854415|NCT04007133|Other|Girerd test|This is a simple and quick questionnaire, composed of 6 questions with a binary yes/no answer. It allows to assess the degree of compliance with the prescribed treatment to better identify the constraints related to the treatment.
15854416|NCT04007120|Drug|RVT-1601|Inhaled RVT-1601 administered once daily over two days
15854417|NCT04007107|Drug|Semaglutide (administered by DV3396 pen)|Subjects will receive 1 single dose of semaglutide 0.25 mg on 1 day
15854418|NCT04007107|Drug|Semaglutide (administered by PDS290 pen)|Subjects will receive 1 single dose of semaglutide 0.25 mg on 1 day
15854419|NCT04007094|Drug|ViviGen Cellular Bone Matrix|Study participants will receive local autograft milled bone on one side of the fusion and an equal amount of Depuy Synthes ViviGen on the opposite side of the fusion
15854420|NCT04007081|Procedure|Bone Marrow Aspiration|collection of approximately 40 mL of bone marrow aspirate
15854421|NCT04007081|Diagnostic Test|Ultrasound Imaging of Salivary Glands|Salivary gland size will be measured by ultrasound.
15854422|NCT04007081|Other|Salivary Assay|Whole saliva production rates (sialometry) will be measured under unstimulated (first passive drool method) and stimulated (chewing gum) saliva collection conditions
15854423|NCT04007081|Other|Quality of Life Instruments|Participants will self-assess with the following Quality of Life (QoL) surveys: University of Michigan Xerostomia related quality of life scale (XeQOL), the MD Anderson Dysphagia Index (MDADI), and the VAS xerostomia questionnaire.
15854424|NCT04007068|Diagnostic Test|FDG PET/CT|FDG PET/CT baseline, month 1, month 4, month 10, than every 6 months
15854425|NCT04007055|Diagnostic Test|Point of care screening for HPR|HPR testing using VerifyNow testing system. HPR is defined platelet reactivity units are greater than 234
15854426|NCT04007055|Drug|Ticagrelor 90mg|Participants who test positive for HPR will be prescribed ticagrelor 90mg twice daily instead of standard therapy with clopidogrel 75mg daily
15854427|NCT04007029|Biological|Chimeric Antigen Receptor T-Cell Therapy|Given Autologous anti-CD19/anti-CD20 CAR-expressing naive/memory T cells IV
15854428|NCT04007029|Drug|Cyclophosphamide|Given IV
15854429|NCT04007029|Drug|Fludarabine Phosphate|Given IV
15854430|NCT04007029|Biological|Tocilizumab|Given IV
15854431|NCT04007016|Procedure|"a new osteotomy from the inner L shaped iliac osteotomy"|"There were two ostectomies were used in the osteotomy. The first was was a cured and 5mm width and the second one was straight 1.5cm width. All the directions was started from the inner to outer just a bove the triradiate cartilage and its shape likeL"
15854432|NCT04007003|Behavioral|training in optimal insulin injection technique|the training will be delivered in person as well as through online training modules via the BD and Me(TM) platform
15854433|NCT04006990|Behavioral|Provision of recliner chairs and encouragement to get out of bed|Provision of recliner chairs and encouragement to get out of bed
15854434|NCT04006977|Dietary Supplement|a multistrain probiotic product (DSF)|In Arm 2, participants will receive standard medical therapy plus the multistrain probiotics (DSF), 4 sachets per day.
15854435|NCT04006977|Dietary Supplement|Placebo|In Arm 1, participants will receive standard medical therapy plus the placebo.
15854436|NCT04006964|Device|Resmon PRO FULL v2|Measurement of lung impedance by the Forced Oscillation Technique
15854437|NCT04006951|Other|Biological collection|"Blood samples are collected at different times :
~Before any treatment
~After pre-operative radiochemotherapy and before surgery (if applicable)"
15854438|NCT04006938|Behavioral|Single Bout ('S')|Each subject will perform a single bout of 30-minutes of moderate-intensity cycling before breakfast
15854439|NCT04006938|Behavioral|Multiple Bout ('M')|Each subject will perform three (3) 10-minute bouts of moderate intensity cycling before breakfast, lunch and dinner
15854440|NCT04006925|Drug|Sodium Oxybate|"Sodium Oxybate will be titrated up weekly by 1.5g nightly dose increments from an initial 4.5g total nightly dose (which could be given in two unequal doses if needed, or one single dose no greater than 4.5g) to an optimal individual dose based on clinical response on RBD symptoms and tolerance, to a maximum nightly dose of 9g (flexible dose period lasting up to 8 weeks). The optimal dose will then be continued for at least 4 weeks (stable dose)."
15854441|NCT04006925|Other|Placebo|Placebo will be similar in appearance, smell and flavor to the subjects, so that the investigators and participants will be unable to distinguish it from sodium oxybate.
15854442|NCT04006912|Procedure|phacoemulsification and Toric intraocular lens implantation|A clear corneal incision is made in a different position
15854443|NCT04006899|Device|Bioelectrical Impedance Monitor|Subjects had been under the test of three commercially available devices and the device that the investigators had developed.
15854444|NCT04006886|Dietary Supplement|Gluten-free diet|After run-in phase with normal diet under Observation, patients will be on a gluten-free diet for two months.
15854445|NCT04006873|Drug|Tezacaftor/Ivacaftor + Ivacaftor|As per description in arms.
15854446|NCT04006873|Drug|Placebo oral tablet|As per description in arms
15854447|NCT04006860|Drug|SHC014748M Capsules|SHC014748M Capsules: 200mg
15854448|NCT04006847|Drug|Eicosapentaenoic Acid|Eicosapentaenoic Acid once per day orally
15854449|NCT04006847|Drug|Tyrosine kinase inhibitor|Tyrosine kinase inhibitor to be administered at subjects' pre-study dose
15854450|NCT04006834|Other|No intervention involved|No intervention involved
15854451|NCT04006821|Drug|PD-1 antibody|Camrelizumab will be administered 200mg iv every 2 weeks until disease progression or lasts for two years.
15854484|NCT04006522|Drug|89Zr-DFO-Atezolizumab|89Zr-DFO-Atezolizumab infusion
15854453|NCT04006808|Biological|PED-HZ/su|GSK's candidate vaccine- PED-HZ/su. is administered intramuscularly in the deltoid of the non-dominant arm, on a two-dose schedule in the two investigational groups.
15854454|NCT04006795|Other|Serum|Participants will be topically applied adhesive patch containing developmental serum
15854455|NCT04006795|Other|Lotion|Participants will be topically applied adhesive patch containing developmental lotion
15854456|NCT04006795|Other|Cream|Participants will be topically applied adhesive patch containing developmental cream
15854457|NCT04006795|Other|Normal Saline|Participants will be topically applied adhesive patch containing normal saline
15854458|NCT04006782|Device|Narrow dental implants|Insertion of narrow dental implants in multiple fixed prosthesis
15854459|NCT04006769|Drug|Entacapone|Entacapone tablet
15854460|NCT04006769|Drug|Imatinib Mesylate|Imatinib Mesylate tablet
15854461|NCT04006756|Behavioral|Online cognitive training 1|Eight-week online cognitive training program, three times a week for 45 minutes. The training contains several games that are designed to train cognitive functions.
15854462|NCT04006756|Behavioral|Online cognitive training 2|Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games.
15854463|NCT04006743|Behavioral|The swaddling group|The newborns were placed in a supine position on a 90 cm2 soft fabric for swaddling procedure. The upper side of the bandage was aligned with the shoulder of the newborn. Newborns' arms were put in a flexion position. The top of the body was completely covered with a bandage. The infant's head can move freely. The swaddling procedure took about one minute. In the study, swaddling process was applied 10 minutes before the painful procedure. The swaddled newborns remained in the swaddling during the procedure and for 5 minutes after the procedure.
15854464|NCT04006743|Behavioral|The expressed breast milk group|In terms of the reliability of the study results, nothing was orally given to the preterm infant at least 30 minutes before the procedure. As recommended in the studies, 2 ml oral breast milk was given to preterm infants before the procedure. In the study, breast milk was given slowly to the upper part of the tongue of each preterm infant from his/her own mother as a single dose before OGT insertion. As a result, preterm was ensured to take all of 2 ml breast milk by reducing the aspiration risk of breastmilk. The breast milk was given without touching the tip of the injector to the newborn's mouth. The preterm infants were not allowed to suck the tip of the injector.
15854465|NCT04006743|Behavioral|The facilitated tucking group|Facilitated tucking was given in supine position by holding the arm and legs of the preterm infant to the body by the researcher. In line with the literature, facilitated tucking was initiated 3 minutes before OGT insertion in order for the newborn to feel the fetal position and to cope with the painful procedure. The preterm was kept in fetal position during the procedure and for 5 minutes after the procedure.
15854466|NCT04006743|Behavioral|The swaddling and expressed breast milk group|Swaddling procedure was conducted by the researcher to the preterm infant 10 minutes before the OGT insertion procedure. 2 ml breast milk was administered by the researcher to preterm using a sterile injector as a single dose for 2 minutes before OGT insertion procedure. The preterm was remained in swaddling during the OGT insertion procedure and for 5 minutes after the process.
15854467|NCT04006743|Behavioral|The facilitated tucking and expressed breast milk group|Facilitated tucking method was applied right after giving 2 ml breast milk by the researcher to the preterm 3 minutes before OGT insertion procedure. Preterm newborn remained in facilitated tucking during the procedure and for 5 minutes after the procedure.
15854468|NCT04006717|Device|Low Level Laser therapy|Diode laser (EPIC™ BIOLASE) with wavelength 940nm
15854469|NCT04006717|Procedure|Intra canal Cryotherapy|Irrigation with cold saline 2-4 C
15854470|NCT04006704|Drug|D/C/F/TAF FDC placebo|Participants will receive matching placebo tablet (whole and split) of D/C/F/TAF 675/150/200/10 mg FDC on Day 1 as intake period 1 and intake period 2.
15854471|NCT04006691|Drug|UGN-101 instillations|Treatment with UGN-101 once weekly for a total of 3-6 times; in a retrograde fashion.
15854472|NCT04006678|Procedure|computer guided sandwich osteotomy|segmental sandwich osteotomy will be done for vertically deficient ridges in anterior area of the maxilla. Either using surgical guides (Computer guide segmental sandwich osteotomy technique) for study group and conventional segmental sandwich osteotomy technique for control group.
15854473|NCT04006665|Diagnostic Test|Lung Ultrasonography (Baseline)|Lung Ultrasonography will be performed prior to docking Robotic arms in basal three lung zones on both sides.
15854474|NCT04006665|Diagnostic Test|Lung Ultrasonography ( At the end of surgery)|Lung Ultrasonography will be performed after removal of Robotic arms and before extubation in basal three lung zones on both sides to assess degree of atelectasis.
15854475|NCT04006652|Drug|ApoGraft|ApoGraft is a cell based product, manufactured with mobilized peripheral blood.
15854476|NCT04006639|Procedure|Analgesic Technique|Patients undergoing tracheostomy procedure must be administered with analgesics, such Lidocaine 20% or Bupivacaine 0.5%
15854477|NCT04006613|Other|Circuit Training|20 minutes of High Intensity Aerobic Training (HI) on treadmill: 2 minutes warm up + 4x 4 minutes HI+ 2 minutes of active recovery; 10 minutes of dynamic balance training; 10 minutes of functional strength training.
15854478|NCT04006613|Other|Usual Care|Exercises aimed at improving mobility and balance
15854479|NCT04006600|Procedure|Sphincter saving proctectomy|"After rectal resection, when colorectal anastomosis is subperitoneal, it is currently recommended to perform a protective stoma to reduce the potential consequences of a fistula. This stoma, which is intended to be temporary, appears to be permanent in 6 to 32% of cases in the literature.
~The objective of the study is therefore to look for a statistical link between the persistence of a permanent stoma and the intraoperative difficulty represented by pelvic anatomical stress."
15854480|NCT04006587|Device|incentive spirometer|patients were instructed how to use the IS in a seated or semi-seated position, and to maintain sustained maximal inspiration for 3-5 seconds before exhalation, ten times per hour, and for at least eight hours a day.
15854481|NCT04006574|Other|Exercises|Core stabilization
15854482|NCT04006561|Radiation|A treatment protocol of combined chemoradiation delivered in the manner of hyperfractionated conformal whole-brain radiation therapy|Each freshly-diagnosed patient with primary CNS lymphoma will be treated with combined chemoradiation in a sandwiched way, in which 2 cycles of induction chemotherapy with intravenous methotrexate (MTX in a conventional dose of 1g/m2) and intrathecal MTX are followed by a complete course of hyperfractionated WBRT and then high-dose cytarabine for 2 cycles.
15854485|NCT04006522|Procedure|Positron Emission Tomography/Computed Tomography|PET/CT scan 7 days (± 1 day) after infusion of 89Zr-DFO-Atezolizumab.
15854486|NCT04006509|Behavioral|Prenatally Delivered Lactation Educational Program|The support person (SP) of mothers at risk for preterm birth will be educated on how to use a breast pump and instructions regarding breast milk expression and have a pump in their hospital room
15854487|NCT04006496|Behavioral|Expressive Writing Coaching|For the intervention group, a trained expressive writing expert/coach will introduce the expressive writing concept to consented patients during the first visit, followed by an introduction of the first expressive writing exercise and prompt. The expert/coach will introduce new writing prompts at each subsequent visit. A script containing each visit's writing prompt and instructions will also be left with the patients for future use and/or reference. The trained clinician will collect, read, and analyze the writing sample using a health coaching technique by: 1) summarizing what the patient wrote, 2) evoking double-sided reflection by reading back the writing sample to the patient, and 3) developing a metaphor and review with the patient. Patients will also have the opportunity to ask the trained clinician questions and receive guidance.
15854488|NCT04006483|Drug|Stannous fluoride dentifrice|Stannous fluoride (0.454%) dentifrice
15854489|NCT04006483|Drug|Positive control dentifrice|Positive control dentifrice containing (0.3%) triclosan.
15854490|NCT04006483|Drug|Negative control dentifrice|Negative control dentifrice containing either sodium fluoride (0.243%) or sodium monofluorophosphate (0.76%)
15854491|NCT04006470|Drug|Stannous fluoride dentifrice|Stannous fluoride (0.454%) dentifrice
15854492|NCT04006470|Drug|Positive control dentifrice|Positive control dentifrice containing potassium nitrate or arginine.
15854493|NCT04006470|Drug|Negative control dentifrice|Negative control dentifrice containing either sodium fluoride (0.243%) or sodium monofluorophosphate (0.76%)
15854494|NCT04006457|Drug|PF-06651600|50 mg oral tablets
15854495|NCT04006457|Biological|Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine|Single intramuscular injection administered to patients participating in the vaccine sub-study
15854496|NCT04006457|Biological|Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine|Single intramuscular injection administered to patients participating in the vaccine sub-study
15854497|NCT04006431|Other|embolization|Retrospective, observational collection with division of patients into two groups according to unilateral or bilateral embolization of the porstatic arteries.
15854498|NCT04006405|Diagnostic Test|GAG score|blood and urine samples to determine GAG scores
15854499|NCT04006392|Device|Erchonia FX-635|The Erchonia FX-635 has three independent 17 milliWatts (mW) 635 nanometer (nm) red laser diodes mounted in scanner devices.
15854500|NCT04006392|Device|Placebo Laser|Non-therapeutic output.
15854501|NCT04006366|Behavioral|Time restricted feeding|We propose a pilot and feasibility trial of a 10 hour time restricted eating intervention among post-bariatric surgery patients.
15854502|NCT04006353|Drug|ABT|320 mg, Intravenous infusion
15854503|NCT04006353|Drug|RIF|600mg q.d.
15854504|NCT04006340|Combination Product|triple therapy|esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg twice a day for 10 days
15854505|NCT04006340|Combination Product|quadruple therapy|esomeprazole 40 mg and bismuth 300mg twice daily, tetracycline 500 mg four times daily, metronidazole 500mg three times daily for 10 days
15854506|NCT04006340|Diagnostic Test|dual-priming oligonucleotide-based multiplex (DPO)-PCR test|Resistance of clarithromycin 23S rRNA point mutation
15854507|NCT04006327|Other|No intervention will be provided as this study is a cross-sectional observational study.|This item is not applicable because this study is a cross-sectional observational study and no intervention will be provided to participants.
15854508|NCT04006314|Other|Autologous platelet rich plasma and dextrose solution.|"Autologous platelet rich plasma are injected into the knee joint and pes anserinus complex.
~Dextrose solutions are injected to the genicular nerves."
15854509|NCT04006301|Drug|JNJ-74699157|Participants will receive JNJ-74699157 orally.
15854515|NCT04006275|Drug|Sonovue and Sonazoid|"Subjects were randomized to receive SonoVue firstly and Sonazid secondly after wash out period. Between the wash out period(at least 30min) and after whole trial, the patients was carefully observed at our department for at least 30min.
~contast agent dose: Sonazoid (0.12 μL/kg of perflubutane microbubbles) or SonoVue (2.4 mL) in a 1:1 ratio."
15854516|NCT04006275|Drug|Sonazoid and Sonovue|"Subjects were randomized to receive Sonazoid firstly and SonoVue secondly after wash out period. Between the wash out period(at least 30min) and after whole trial, the patients was carefully observed at our department for at least 30min.
~contast agent dose: Sonazoid (0.12 μL/kg of perflubutane microbubbles) or SonoVue (2.4 mL) in a 1:1 ratio."
15854517|NCT04006262|Drug|Nivolumab 10 MG/ML|"Neo-adjuvant treatment : 240 mg intravenous (I.V.) in 30 minutes - every 2 weeks - 6 cycles
~Adjuvant treatment : 480mg I.V. in 30 minutes - every 4 weeks - 9 cycles"
15854518|NCT04006262|Drug|Ipilimumab 200 MG in 40 ML Injection|Neo-adjuvant treatment : 1mg/kg over 30 minutes every 6 cycles - 2 cycles
15854519|NCT04006249|Diagnostic Test|dental probes|Measurement of the depth of the periodontal pockets and clinical loss
15854520|NCT04006236|Other|Experimental Infant Formula|Feed Ad Libitum
15854521|NCT04006236|Other|Control Infant Formula|Feed Ad Libitum
15854599|NCT04005573|Other|no intervention|no intervention is given
15854524|NCT04006210|Combination Product|ND0612 Solution for SC infusion|Levodopa Carbidopa solution administered SC via infusion pump
15854525|NCT04006210|Combination Product|Placebo for SC infusion|Placebo solution administered SC via infusion pump
15854526|NCT04006210|Drug|Carbidopa and Levodopa 25mg/100mg|Encapsulated Carbidopa and Levodopa USP 25mg/100mg
15854527|NCT04006210|Drug|Placebo for Carbidopa and Levodopa 25mg/100mg|Encapsulated Placebo for Carbidopa and Levodopa USP 25mg/100mg
15854528|NCT04006197|Other|laryngostroboscopy and histoh-pathology|videolaryngoscopy and laryngostroboscoby will be performed .the latter will be pathological in case of highly reduced or abolished amplitudes of vocal fold vibration and if there is reduction of mucosal wave propagation.also direct microlaryngoscopy under general anathesia will be done and excesional biobsy will be taken followed by histopatholpgical examination .the histological finding will be catagorized into the following categories according to (WHO): squamous cell hyperplasia with non dysplasia,mild dysplasia,moderate dysplasia,sever dysplasia,carcinoma in situ and squamous cell carcinoma.
15854529|NCT04006184|Other|Chart review|Retrospective review of medical records at a single site with six physicians
15854530|NCT04006171|Diagnostic Test|C type natriuretic peptide|Serum level of CNP in PCOS and healthy women
15854531|NCT04006158|Device|LED bed|Low risk FDA cleared full body LED bed
15854532|NCT04006145|Drug|Elobixibat|Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT).
15854533|NCT04006145|Drug|Placebo oral tablet|Placebo identical in appearance to active drug
15854534|NCT04006132|Device|Fitting of Ponto 3 SuperPower|Bone-anchored hearing systems (BAHS) use the body's natural ability to transfer sound through bone conduction. The sound processor picks up sound and converts it into vibrations that are transferred through the skull bone to the inner ear (cochlea). Thus, for patients with conductive or mixed hearing losses, patients with lasting hearing loss following a middle ear disease or malformations (such as microtia), the vibrations are bypassing the conductive problem in the ear canal or middle ear. The intervention in this study is audiologically fitting two bone-anchored sound processors (Ponto 3 SuperPower) to patients that are already bilaterally implanted with abutments.
15854535|NCT04006119|Biological|Ad-RTS-hIL-12|"intratumoral injection of Ad-RTS-hIL-12
~2.0 x 10^11 viral particles (vp) per injection"
15854536|NCT04006119|Drug|Veledimex|20mg/day 15 oral daily doses of veledimex
15854537|NCT04006119|Drug|Cemiplimab-Rwlc|Infusion every 3 weeks (350mg)
15854538|NCT04006093|Drug|Apixaban Oral|one Tablet 5mg
15854539|NCT04006080|Biological|Vedolizumab|Intravenously administered selective leukocyte adhesion molecule inhibitor
15854540|NCT04006067|Other|changing surgical gloves|All the surgical team including surgeons, surgical assists and scrub technicians replaced their outer surgical gloves with a new pair of sterile gloves just prior to abdominal closure.
15854541|NCT04006054|Drug|Dexmedetomidine|When the patients who suffered traumatic brain injury are in NICU，Dexmedetomidine is given for sedation about 5 days .
15854542|NCT04006054|Drug|Midazolam|When the patients who suffered traumatic brain injury are in NICU，Midazolam is given for sedation about 5 days .
15854543|NCT04006041|Drug|Toripalimab|Patients received toripalimab 240 mg IVDRIP on days 1 and 22 during neoadjuvant radiotherapy.
15854544|NCT04006041|Drug|Paclitaxel/cisplatin|Patients received 4 cycles of paclitaxel/cisplatin (paclitaxel 50mg/m2 and cisplatin 25 mg/m2) on days 1, 8, 15, 22 during neoadjuvant radiotherapy.
15854545|NCT04006041|Radiation|Intensity-modulated radiotherapy|All patients received external-beam radiation using intensity-modulated radiotherapy. The prescribed dose is 44 Gy in 20 fractions over 4 weeks.
15854546|NCT04006041|Procedure|Esophagectomy|A transthoracic (Ivor-Lewis) esophagectomy is performed 6-8 weeks after CRT completion.
15854547|NCT04006015|Other|No intervention being delivered.|No interventions are being delivered.
15854548|NCT04006002|Other|Metabolic and Hormonal profile|To assess changes in metabolic profiles and body metrics such as weight and BMI in these patients after an endoscopic or surgical bariatric intervention
15854549|NCT04005989|Biological|Stromal Cells Injection|Adipose stromal cell
15854550|NCT04005963|Diagnostic Test|13N-NH3 PET cardiac blood flow perfusion rest and load imaging|"Immediately after the bedside injection of 13N-NH3 370 MBq, dynamic 2D collection of heart images 10 min, scanning 1 bed; , a total of 6 min), 3min bedside injection 13N?NH3 370-540 MBq immediately after the dynamic 2D collection of heart image 10 min. Both rest and load imaging are corrected for CT attenuation.
~Image reconstruction is carried out by the method of maximum expectation of an ordered subset, the dynamic image is divided into the early phase of the first 2 min and the late phase of the last 8 min, the captured image is replayed (VIP replay) of the volume image protocol and the gated data is reconstructed."
15854551|NCT04005950|Device|Scalpel Bougie technique|ScalpelCric Set
15854552|NCT04005950|Device|modified Scalpel Bougie technique|ScalpelCric Set plus speculum
15854553|NCT04005937|Diagnostic Test|H-reflex|Electrical stimulation of Group Ia afferent of muscle spindle
15854554|NCT04005924|Other|arabinogalactan|Arabinogalactan will be mixed into sugar-free blackberry jam and consumed with the provided bread.
15854555|NCT04005911|Device|Themography|Using a FLIR camera, a thermographic recording will be taken of the patient while breathing. Simultaneously, the research investigator will record the thoracic impedance-based respiratory rate as well as manually count respirations in one minute.
15854556|NCT04005898|Device|Near-infrared fluorescence cholangiography|Real-Time Fluorescence Imaging (VISERA ELITE II Imaging System). These device is used to identify anatomy, using infrared light that causes the indocianine green to fluoresce.
15854557|NCT04005885|Device|comfilcon A|Contact Lens
15854558|NCT04005885|Device|somofilcon A|daily disposable contact lens
15854559|NCT04005885|Device|stenfilcon A|daily disposable contact lens
15854560|NCT04005872|Drug|Nano Silver Fluoride|Nano silver fluoride (NSF) is a new material consisting of nano silver particles, chitosan and sodium fluoride. It is a bacteriostatic and bactericidal compound.
15854561|NCT04005872|Drug|Calcium hydroxide|Calcium hydroxide is a gold standard for indirect pulp capping which induces hard tissue.
15854600|NCT04005560|Other|no interventional study|no interventional study
15854699|NCT04004715|Dietary Supplement|Military Ration Entree|chili and beans entree; current meal component of the meals ready to eat rations
15854700|NCT04004702|Drug|Levetiracetam|Levetiracetam 500mg twice a day
15854564|NCT04005846|Device|Transcranial Direct Current Stimulation (tDCS)|The active session of tDCS will consist in applying two anodes over M1 bilaterally (C3 and C4 according to the 10-20 international EEG placement) and the cathodes over the occipital areas (O1 and O2), and to inject 2 mA for 20 minutes through sponge electrodes (35 cm²) placed on the scalp using the Startsim 8 (Neuroelectrics, Barcelona). The sham tDCS will use the same montage and device but direct current will only be injected for 30 seconds, with a ramp-up and ramp-down 15 seconds period, to mimic the somatosensory effects of active tDCS.
15854565|NCT04005833|Diagnostic Test|spirometry|The lung function (FEV1) will be assessed at follow-up visits at 2 months, 12 months and 36 months after inclusion.
15854566|NCT04005820|Other|Radiologic Centralized Review|The patient's imaging will be examined in one of the examination centers
15854567|NCT04005820|Other|Tissue sample (tumor, sung, urine)|all the samples will be made during the patients care
15854568|NCT04005807|Drug|BPN-14967|BPN-14967 oral capsules
15854569|NCT04005807|Drug|Placebo|Oral capsules
15854570|NCT04005794|Behavioral|VR social skills training|Social skills game that we developed in the R21 phase will be used across 10 sessions of training in the lab. Each session is about 1 hour long. Participants come to the lab twice a week for 5 weeks.
15854571|NCT04005794|Behavioral|Cognitive training|Commercially available brain fitness training program will be used to control for the time spent in the lab and associated social interactions as well as the total exposure to computerized games.
15854572|NCT04005781|Drug|Hydroxychloroquine sulphate|After a stabilization period of 20 min and 10 min after the first blood collection, Plaquenil (Hydroxychloroquine sulfate) will be administered per os (total dose of 400 mg) in a randomized, double-blinded fashion.
15854573|NCT04005781|Drug|Placebo|After a stabilization period of 20 min and 10 min after the first blood collection, Placebo will be administered per os (2 tablets) in a randomized, double-blinded fashion.
15854574|NCT04005768|Drug|Hydroxychloroquine Sulphate|After a stabilization period of 20 min and 10 min after the first blood collection, Plaquenil (Hydroxychloroquine sulfate) will be administered per os (total dose of 400 mg) in a randomized, double-blinded fashion.
15854575|NCT04005768|Drug|Placebo|After a stabilization period of 20 min and 10 min after the first blood collection, Placebo will be administered per os (2 tablets) in a randomized, double-blinded fashion.
15854576|NCT04005755|Drug|Maxigesic® IV|acetaminophen 1000 mg + ibuprofen 300 mg, 100 ml solution for infusion
15854577|NCT04005729|Drug|Cangrelor 50 MG|30 mcg/kg bolus, then 4h infusion 4 mcg/kg/min
15854578|NCT04005716|Drug|Tislelizumab, Carboplatin /Cisplatin, Etoposide|Tislelizumab (200 mg IV Q3W) in combination with chemotherapy consisting of etoposide (100 mg/m² IV Days 1-3 of each 21-day cycle) and platinum (cisplatin 75 mg/m² IV Q3W or carboplatin area under the plasma or serum concentration-time curve (AUC) 5 IV Q3W) for 4 cycles. Then maintenance consists of Tislelizumab Q3W and will continue until disease progression, loss of clinical benefit, unacceptable toxicity, or withdrawal of informed consent.
15854579|NCT04005716|Drug|Carboplatin / Cisplatin, Etoposide|Placebo Q3W in combination with chemotherapy consisting of etoposide (100 mg/m² IV Days 1-3 of each 21-day cycle) and platinum (cisplatin 75 mg/m² IV Q3W or carboplatin AUC 5 IV Q3W) for 4 cycles. Then maintenance consists of Placebo Q3W and will continue until disease progression, loss of clinical benefit, unacceptable toxicity, or withdrawal of informed consent.
15854580|NCT04005690|Drug|Cobimetinib|Given PO
15854581|NCT04005690|Drug|Olaparib|Given PO
15854582|NCT04005677|Diagnostic Test|The serum and urine from people enrolled are used to analyze the DNA, RNA, protein, metabolites, immune status|The serum and urine from people enrolled are used to analyze the DNA, RNA, protein, metabolites, immune status
15854583|NCT04005664|Drug|Phenylephrine|Prophylactic phenylephrine infusion as part of fluid coload
15854584|NCT04005651|Device|POD L GF IOL|Cataractous lens will be removed in the study eyes and the POD L GF IOL will be implanted in the capsular bag
15854585|NCT04005651|Device|Symfony® IOL|Cataractous lens will be removed in the study eyes and the Symfony® IOL will be implanted in the capsular bag
15854586|NCT04005651|Device|AcrySof® IOL|Cataractous lens will be removed in the study eyes and the AcrySof® IOL will be implanted in the capsular bag
15854587|NCT04005638|Biological|blood sample|45 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
15854588|NCT04005638|Biological|urine sample|12 ml
15854589|NCT04005612|Dietary Supplement|vitamin D3|50,000 IU VD3 / week for 8 weeks
15854590|NCT04005612|Dietary Supplement|omega-3 fatty acid|300 mg of omega 3-FA once daily for 8 weeks
15854591|NCT04005612|Dietary Supplement|vitamin D3 and omega-3 fatty acid|50,000 IU VD3 / week for 8 weeks and 300 mg of omega-3FA once daily for 8 weeks
15854592|NCT04005612|Other|control|no intervention
15854593|NCT04005599|Drug|Remifentanil group|Venous general anesthesia with propofol and remifentanil.
15854594|NCT04005599|Drug|Magnesium sulfate group|Venous general anesthesia with propofol and magnesium sulfate
15854595|NCT04005586|Device|Light Delivery Device (LDD)|Study eye will undergo Light delivery Device treatments
15854596|NCT04005573|Dietary Supplement|VD3|VD3 50000 IU/ week for 8 weeks
15854597|NCT04005573|Dietary Supplement|omega 3- FA|Omega 3 FA group 300 mg once daily for 8 weeks
15854598|NCT04005573|Dietary Supplement|VD3 and omega- 3FA|50000 IU VD3/week for 8 weeks and 300 mg of omega- 3 FA once daily for 8 weeks
15854601|NCT04005547|Behavioral|Promoting Awareness through Live Movement and Sound for youth with Autism Spectrum Disorder|Session 1 - Let's Talk About Relationships Session 2 - Let's Talk About Intimate Relationships Session 3 - Let's Talk About Sex Session 4 - Let's Talk About Protection Session 5 - Let's Talk About Communication *Bring your Trusted Adult* Session 6 - Let's Talk About Growing Up
15854602|NCT04005534|Drug|Regular group|Ultrasound examination of the brachial plexus 2 days before the surgery. Ultrasound guided brachial plexus blockade and sedation on the day of surgery.
15854603|NCT04005534|Drug|Preemptive group|Ultrasound guided brachial plexus blockade 2 days before the surgery. Ultrasound guided brachial plexus blockade and sedation on the day of surgery.
15854604|NCT04005521|Behavioral|Preventive intervention|Preventive, structured exercise protocol
15854605|NCT04005508|Diagnostic Test|Overnight sleep study|The patients will undergo an overnight sleep study using Watch-PAT sleep study device
15854607|NCT04005482|Other|Rate control|Rate control according to the Atrial fibrillation - ESC Guidelines 2016
15854608|NCT04005469|Drug|Treprostinil|Treprostinil (Remodulin) will be administered IV by a standard 3 + 3 dose-escalation approach. This dosing model will be followed until a target dose of 15 mg/kg/min is achieved or if it is medically determined that side effects prevent dose escalation. IV infusion will commence approximately 2-3 hours before transplantation of the kidney graft and will continue for approximately 48 hours after completion of surgery, unless hemodynamic changes or tolerability require discontinuation of treprostinil.
15854609|NCT04005456|Dietary Supplement|Supplements and/or medical foods|Personalized dietary supplementation (e.g., multivitamins/minerals, probiotics, specialized pro-resolving mediators, marine oil, vitamin D, hormone support, methylation support, protein drink, phytochemicals, neurocognitive support, targeted ingredients)
15854610|NCT04005456|Behavioral|Behavioral change support program|Program to implement lifestyle and behavioral change according to individuals' need.
15854611|NCT04005456|Other|Food plan|Personalized food plan (e.g., basic wellness food plan, cardiometabolic food plan, high protein high phytonutrient food plan, ketogenic food plan, detoxification food plan, anti-inflammatory food plan, neuro food plan)
15854612|NCT04005443|Other|radiopharmaceutical|his study will consist of a monthly intra-ocular injection of antiangiogenic and a follow-up ophthalmological consultation with OCT and visual acuity score
15854613|NCT04005430|Drug|Episcleral Dexamethasone|Sequestered Transscleral, Controlled-Release Dexamethasone
15854614|NCT04005417|Drug|Stannous fluoride dentifrice|Stannous fluoride (0.454%) dentifrice
15854615|NCT04005417|Drug|Positive control dentifrice|Positive control dentifrice containing potassium nitrate or arginine.
15854616|NCT04005417|Drug|Negative control dentifrice|Negative control dentifrice containing either sodium fluoride (0.243%) or sodium monofluorophosphate (0.76%)
15854617|NCT04005404|Drug|Ropivacaine (sciatic nerve block)|injection of 20 ml ropivacaine 0.375%
15854618|NCT04005404|Drug|Ropivacaine (lumbar plexus block L2-L4)|injection of 20 ml ropivacaine 0.375%
15854619|NCT04005404|Drug|Ropivacaine (lumbar plexus block Th12-L1)|injection of 20 ml ropivacaine 0.375%
15854620|NCT04005391|Other|Offer of Participant's Choice of Contraception Method|Women will be offered a range of contraceptive options (condoms, contraceptive pills, medroxyprogesterone acetate injection, levonorgestrel implant) to choose from; they can decline to start a contraceptive method
15854621|NCT04005378|Other|CSC Step-down intervention|Web-based telemedicine and a smartphone app, to decrease disengagement likelihood
15854622|NCT04005378|Other|Usual Care|Usual Care provided by CSC center
15854623|NCT04005365|Drug|Propranolol|add propranolol in gastric cancer patients who need to receive preoperate chemotherapy
15854626|NCT04005339|Drug|Nanoliposomal Irinotecan|Nanoliposomal irinotecan 70 mg/ IV over 90 minutes, every 14 days
15854627|NCT04005339|Drug|Leucovorin|Leucovorin 400 mg/ IV over 30 minutes, every 14 days.
15854628|NCT04005339|Drug|Fluorouracil|Fluorouracil 2,400 mg/m IV over 46 hours.
15854629|NCT04005326|Procedure|quadratus lumborum block; (Anterior QLB or QLB III)|The patient will be in the lateral position. A low frequency convex probe will be vertically attached above the iliac crest and a needle will be inserted in plane from the posterior edge of the convex probe through the quadratus lumborum in an anteromedial direction. The needle tip will be placed between the psoas major muscle and the quadratus lumborum muscle. After negative aspiration, 30 mL of 0.25 % of bupivacaine will be injected into the fascial plane incrementally, aspirating every 5 ml.
15854630|NCT04005326|Procedure|suprainguinal fascia iliaca block|In supine position, a high frequency linear probe will be placed in the inguinal crease. Scan starting laterally from the femoral artery and nerve in inguinal crease to identify the sartorius muscle, tracing the muscle until it's origin to anterior superior iliac spine. The shadow of the bony of iliac crest & iliacus muscle will be seen, the end point of the injection is deep to the fascia iliaca and above the iliacus muscle in the lateral part of the iliacus muscle. After negative aspiration, 30 mL of 0.25 % of bupivacaine will be injected under the fascial plane incrementally, aspirating every 5 ml.
15854670|NCT04004962|Device|Infrared spectroscopy|Infrared spectroscopy
15854915|NCT04002895|Drug|Foliglurax|Single oral dose of 80 mg [14C]-foliglurax(93µCi/3.44 MBq), 1mg/mL oral solution (prepared from [14C]-foliglurax powder for oral solution)
15854631|NCT04005326|Procedure|Subarachnoid block|"Patients will receive SAB using 25g spinal needle in the lateral position. Fifteen milligrams of hyperbaric bupivacaine will be administered at L3-L4 or at L4-L5 interspace in addition to 25 mcg fentanyl with rapid crystalloid co-load.
~Spinal anesthesia will be considered successful when a bilateral block to T12, as assessed by loss of cold (cold ice) and pain (a 23-gauge needle) sensations, will be established 10 -minutes after the intrathecal injection. If spinal anesthesia failed, such patients will be administered general anesthesia and will be excluded from this study."
15854632|NCT04005313|Device|vibroacoustic device|the participants will receive the vibroacustic device or music therapy
15854633|NCT04005300|Dietary Supplement|standard enteral nutrition|Enteral nutrition was treated within 48 hours after ICU and the calories were 500-750kcal/d
15854634|NCT04005300|Dietary Supplement|restricted enteral nutrition|Enteral nutrition was treated within 48 hours after ICU and the calories were 10-20kcal/kg/d for 3 days
15854635|NCT04005287|Drug|WST-057 (4% pirenzepine) Lose Dose 2mL|Topical Solution
15854636|NCT04005261|Diagnostic Test|C-peptide concentrations|The patients will be grouped by their C-peptide concentrations
15854637|NCT04005248|Diagnostic Test|HCV IgG test|An HCV IgG test (performed on blood already collected for regular STI tests), combined with a questionnaire on sexual risk behavior. If client is HCV IgG positive, a HCV RNA test will be performed.
15854638|NCT04005235|Device|Thorasys Tremoflo C-100 Airwave Oscillometry System (FOT)|Ultrasonography will be used to confirm hemidiaphragm dysfunction after brachial plexus nerve block. In subjects with U/S confirmed hemidiaphragm dysfunction, FOT measurements will be taken before and after nerve block and post-operatively after upper extremity surgery.
15854639|NCT04005222|Drug|SELENIUM|Increased lipid peroxidation associated with ischemia of the anterior segment has been prevented by selenium supplementation.
15854640|NCT04005222|Drug|MELATONIN|Increased lipid peroxidation associated with ischemia of the anterior segment has been prevented by melatonin supplementation.
15854641|NCT04005209|Drug|Ketamine|The experimental group will receive a ketamine intravenous infusion, initiated at 0.2 mg/kg/hr within the first 12 to 24 hours on an inpatient admission for sickle cell pain crisis, and titrated per hospital policy by the inpatient pain service.
15854642|NCT04005209|Other|Pain management|Pain management
15854643|NCT04005196|Diagnostic Test|EEG|Data recording will continue up until a maximum of 120 hours after emergence from sedation or at CVICU discharge. This study period is informed by baseline data from our institution where the median duration of delirium following emergence from coma was 2 days, allowing sufficient time to capture transitions from coma to wakefulness with and without delirium. EEG recordings will be divided in to epochs corresponding to coma, wakefulness, and delirium if present.
15854644|NCT04005170|Drug|Toripalimab|Patients received toripalimab 240 mg on days 1 and 22 during radiotherapy followed by a maintenance phase of toripalimab IV 240 mg every 3 weeks for up to 1 year.
15854645|NCT04005170|Drug|Paclitaxel/Cisplatin|Patients received 5 cycles of paclitaxel/cisplatin (paclitaxel 50mg/m2 and cisplatin 25 mg/m2) on days 1, 8, 15, 22, 29 during radiotherapy.
15854646|NCT04005170|Radiation|Intensity-modulated radiotherapy|All patients received external-beam radiation using intensity-modulated radiotherapy. The prescribed dose is 50.4 Gy in 28 fractions over 5-6 weeks.
15854647|NCT04005157|Procedure|MWA|Patients diagnosed with early-stage NSCLC and signing the informed consent will undergo MWA with the guidance of ENB.
15854648|NCT04005157|Device|ENB|ENB (LungCare Medical Technologies Ltd., Inc, Suzhou, China)will be used to guide bronchoscope into the accurate location of the lesion during MWA.
15854649|NCT04005144|Drug|Binimetinib|Given PO
15854650|NCT04005144|Drug|Brigatinib|Given PO
15854651|NCT04005131|Device|Robot and tDCS on-line|Combined transcranial direct current stimulation(tDCS) on-line and upper extremity rehabilitation robot for 5 times a week for 10 weeks
15854652|NCT04005131|Device|Robot and tDCS on-line after sham tDCS|Combined sham tDCS and upper extremity rehabilitation robot for 5 times a week for 5 weeks, followed by combined tDCS on-line and upper extremity rehabilitation robot for 5 times a week for 5 weeks
15854653|NCT04005105|Behavioral|Intensive management|Management based on premorbid MAP and MPP
15854654|NCT04005092|Device|hCPAP versus HFNC|The patient presented with Acute Cardiogenic Pulmonary Edema will be randomized into either helmet CPAP or HFNC.
15854655|NCT04005079|Drug|Pilocarpine|2% pilocarpine in the postoperative period in addition to standard postoperative drops (Prednisolone acetate and Ofloxacin)
15854656|NCT04005079|Drug|Ofloxacin|Standard of care
15854657|NCT04005079|Drug|Prednisolone|Standard of Care
15854658|NCT04005066|Drug|Elunate®|Fruquintinib treatment: 4mg in the Cycle 1,administration for 3 weeks followed by 1 week break, and administration every day for the first 21 days.5mg ,administration for 3 weeks followed by 1 week break, and administration every day for the first 21 days
15854659|NCT04005053|Drug|N-acetyl cysteine|3600 or 5400 mg/day N-acetyl cysteine
15854660|NCT04005053|Drug|Placebo oral tablet|Placebo
15854661|NCT04005040|Procedure|Mobile X-ray|Evaluating the effect of mobile x-ray compared to x-ray at the Hospital
15854662|NCT04005027|Other|Intermittent graded exercise test|Participants will run on a treadmill until volitional exhaustion. The speed of the treadmill belt will increase incrementally every 3 minutes. Within each 3 minute stage the speed will vary between the target speed and a complete pause (e.g target speed = 8 km/hr)
15854663|NCT04005014|Other|Myopia prediction algorithm|Candidate predictors included age at examination, SE, and annual progression rate. Using these predictors, the algorithm will be used to predict SE and whether patients will progress to high myopia in the subsequent 10 years.
15854664|NCT04005001|Diagnostic Test|HindSight|Clinical decision support (CDS) system for sepsis detection, optimized by encoder
15854665|NCT04005001|Diagnostic Test|InSight|Clinical decision support (CDS) system for sepsis detection
15854666|NCT04004988|Drug|Tirzepatide|Administered SC
15854667|NCT04004988|Device|Prefilled syringe (PFS)|PFS used to administer tirzepatide
15854668|NCT04004988|Device|Auto-injector (AI)|AI used to administer tirzepatide
15854669|NCT04004975|Drug|Anlotinib|Anlotinib is a multitarget receptor tyrosine kinase inhibitor which inhibits vascular endothelial growth factor receptor (VEGFR) 1-3, fibroblast growth factor receptor (FGFR) 1-4, platelet-derived growth factor receptors (PDGFR) α/β, c-Kit, and Met.
15854671|NCT04004949|Other|Assessment of scapular balance angle and upper extremity sensorimotor function|The patients were diagnosed with the Lateral scapular slide test using Palpation meter (PALM) device, Fugl-Meyer upper extremity (FMUE) Scale scores & scapular balance angle test (SBA).
15854672|NCT04004936|Other|EQUIPPED with Active Feedback|Enhancing Quality of Prescribing Practices for Older Adults Discharged from the Emergency Department (EQUIPPED is a multi-component program to reduce the prescribing of potentially inappropriate medications (PIMs) to older adults upon discharge from the Emergency Department (ED). It has three core components: 1) provider education, 2) Electronic Health Record (EHR)-based clinical decision support (CDS) including pharmacy quick order sets to facilitate provider order entry, and 3) provider audit and feedback with peer benchmarking. The active feedback group will receive one-to-one (1:1) in-person academic detailing from a professional colleague that includes in-person audit, feedback, and peer benchmarking and provide on-site expertise.
15854673|NCT04004936|Other|EQUIPPED with Passive Feedback|Enhancing Quality of Prescribing Practices for Older Adults Discharged from the Emergency Department (EQUIPPED is a multi-component program to reduce the prescribing of potentially inappropriate medications (PIMs) to older adults upon discharge from the Emergency Department (ED). It has three core components: 1) provider education, 2) Electronic Health Record (EHR)-based clinical decision support (CDS) including pharmacy quick order sets to facilitate provider order entry, and 3) provider audit and feedback with peer benchmarking. The passive feedback group will receive monthly provider feedback via an electronic dashboard with audit, feedback and peer benchmarking.
15854674|NCT04004923|Procedure|Monopolar hysteroscopy|Unipolar resectoscopes are used in this group and the distention fluid is mannitol
15854675|NCT04004923|Procedure|Bipolar hysteroscopy|Bipolar resectoscopes are used in this group and the distention fluid is serum physiologic
15854676|NCT04004910|Other|Plasma soluble TNF receptor pulldown|The Immunoadsorption affinity column, the LW-02 column, uses a proprietary human recombinant protein, single chain TNF-α ligand, covalently linked to a bead resin, that both enhances the capture efficiency of sTNF-Rs while avoiding complications from column leaching. Reduced sTNF-R plasma levels may lead to objective tumor responses.
15854677|NCT04004910|Other|Plasma soluble TNF receptor pulldown + chemotherapy|"The Immunoadsorption affinity column, the LW-02 column, uses a proprietary human recombinant protein, single chain TNF-α ligand, covalently linked to a bead resin, that both enhances the capture efficiency of sTNF-Rs while avoiding complications from column leaching. Reduced sTNF-R plasma levels may lead to objective tumor responses.
~In combined treatment arm the immunopheresis procedure is combined with low dose chemotherapy to potentially enhancing the latter's cytotoxic effect."
15854678|NCT04004910|Drug|Chemotherapy Drugs, Cancer|IV chemotherapy with paclitaxel and carboplatin in low doses on a weekly basis.
15854679|NCT04004897|Diagnostic Test|Optic nerve sheath diameter measurement|Optic nerve sheath diameter measurement is performed with a linear ultrasound probe placed over the eyelid.
15854680|NCT04004884|Drug|Ulipristal Acetate|Assess the variations of liver blood test parameters during UPA treatment for symptomatic uterine fibroids
15854681|NCT04004871|Drug|Nab-paclitaxel, Cisplatin and Fluorouracil|Patients receive Nab-paclitaxel (200mg/m2 on day 1), cisplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before concurrent chemoradiotherapy.
15854682|NCT04004871|Radiation|concurrent chemoradiotherapy|Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
15854683|NCT04004858|Radiation|External beam radiation therapy|Patient will receive 60Gy in 20 fractions as per standard practice
15854684|NCT04004845|Drug|Cytotec|Misoprostol 25mcg vaginal
15854685|NCT04004845|Drug|oxytocin|Oxytocin 10 IU/ml Solution for infusion
15854686|NCT04004845|Device|Cervical Foley Balloon|Cervical Foley will be inflated to 80cc
15854687|NCT04004832|Diagnostic Test|there is not any intervention procedure|there is not any intervention procedure
15854688|NCT04004819|Drug|Rituximab|A lower dosage of rituximab for multiple system atrophy
15854689|NCT04004806|Device|Hill Rom tracking device|Location tracking devices from Hill Rom company.
15854690|NCT04004793|Behavioral|Intensive lifestyle intervention|Participants were will be asked to follow a weight management programme, in accordance with the American Diabetes Association guidelines. Weight loss will be induced with a diet replacement phase using an energy restriction diet (energy deficit by 500~750 kcal/day) for 3 months, with <35% as fat, >15% as protein. The minimum energy intake is 1200kcal/day for men and 1000kcal/day for women.. Additionally, participants were encouraged to increase physical exercise (≥150 minutes of brisk walking every week or ≥10000 steps per day).
15854691|NCT04004793|Drug|Dapagliflozin 10 MG Oral Tablet|The treatment of Dapagliflozin (Forxiga®) will be initiated and maintained at 10mg every morning until the completion of the study.
15854692|NCT04004793|Drug|Placebo Oral Tablet|The treatment of placebo will be initiated and maintained at 10mg every morning until the completion of the study.
15854693|NCT04004754|Drug|Miltefosine (administration is not part of study procedures)|Patients who receive miltefosine in the routine setting will be asked to participate in the study to document their outcomes
15854694|NCT04004741|Procedure|Osteopathic Manipulative Treatment|"The purpose of this research is to investigate the effect of osteopathic manipulative treatment (OMT) focused on somatic dysfunctions commonly associated with arrhythmias on the amount of quantifiable arrhythmias as recorded on a diagnostic device.
~It is known that OMT has a stabilizing effect on the autonomic nervous system, which plays a key role in regulating heart rate and blood pressure. This increases parasympathetic tone and decreases sympathetic tone, which generally stabilizes the heart with an antiarrhythmic effect.
~Previous work has been done showing that osteopathic treatment is a beneficial adjunctive therapy for paroxysmal atrial fibrillation and decreased symptoms, though has not been proven to be helpful for patients with heart failure.
~While the effect of OMT on the neurology has been studied, we would like to further research the effect OMT specifically has on arrhythmias using more quantifiable data from implanted devices."
15854695|NCT04004741|Procedure|Light Touch Therapy|The physician will contact various areas of the body for 120 seconds each to expose the subject to a similar environment as the interventional group, without stimulating the autonomic nervous system.
15854696|NCT04004728|Procedure|1064 Nd:YAG laser|1064 laser - 135J 25ms spot 3mm GLicose - 75% - 3 ml
15854697|NCT04004715|Dietary Supplement|Essential Amino Acid Enriched Whey Protein|protein powder formulation that includes whey and free-form essential amino acids
15854701|NCT04004689|Other|2 times : 6-minute stepper test with a rest of 20min between each test.|"Patients will perform two 6-minute stepper tests separated by a rest period of at least 20 minutes. The second test will begin when the heart rate and the transcutaneous oxygen saturation values will be returned to baseline values. Standardization of the instructions for the test will be based on the actual guidelines for the 6-minute walk test.
~The test will be performed in an isolated room in order to avoid noise or external stimuli which can affect performance. The stepper will be placed near a door and the patient was allowed to put a hand on it if out of balance or exhausted. The height of the step will be fixed to 20 cm. A step was defined as the rise and lowering of one foot. The patient was informed of the time each minute. No other encouragement was given. Heart rate and transcutaneous oxygen saturation will be continuously recorded by a pulse oximetry."
15854702|NCT04004676|Behavioral|20 km time trial performance|20 km time trial cycling test will be conducted to measure the effect of different drinks on performance time
15854703|NCT04004676|Behavioral|Glycogen lowering exercise|Glycogen will be lowered using a 10-min warm-up period at a workload of 50% max wattage power output (Wmax). Thereafter, participants will be instructed to cycle 2-min block periods at alternating workloads of 90% and 50% of Wmax, respectively. This will be continued until the participants are no longer able to complete the 2 min at 90% Wmax. That moment will be defined as the time at which the individual is unable to maintain cycling speed at 60 revolutions/min. At that moment the high-intensity block will be reduced to 80% Wmax. Again, athletes will cycle until they are unable to complete a 2-min block at 80% Wmax, after which the high-intensity block will be reduced to 70% Wmax. Finally, participants will be allowed to stop when pedalling speed could not be maintained at 70% Wmax.
15854704|NCT04004663|Drug|PF-06651600|PF-06651600 100 milligrams (mg) will be provided in 4 different oral formulations (Treatment A,B,C,D). Participants will receive each formulation in one of 4 periods
15854705|NCT04004650|Procedure|Gluteal turnover flap|Link to procedure: https://www.youtube.com/watch?v=u7_vH2_1ZZc
15854706|NCT04004637|Drug|CD7 CAR-T cells infusion|"Biological: CD7 CAR-T cells infusion. Pretreatment: patients enrolled in this study will receive cyclophosphamide or fludarabine plus cyclophosphamide. CD7 CAR-T cells infusion are allowed within 2 weeks after treatment.
~CD7 CAR-T cells infusion: 30-60 minutes before infusion, H1 anti-histamine agents are applied (acetaminophen 30mg,po.; promethazine 25mg,i.v. ; diphenhydramine 0.5-1mg/kg, no more than 50mg.). Non-physiological doses of corticosteroids are not applied for patients during treatment or recovery unless a life-threatening emergency occurs. CD7 CAR-T cells are infused into patients for one or two times, the number of infused CD7 CAR-T cells are 0.5-5×10^6/kg."
15854707|NCT04004624|Device|Ablation|Cardiac Ablation
15854708|NCT04004611|Drug|Mirikizumab|Administered IV and SC
15854709|NCT04004598|Behavioral|golf training|12 weeks of training by Professional Golf Association professional
15854710|NCT04004585|Behavioral|Get Up For Your Health|"The intervention is a 4-week behaviour change intervention underpinned by the Theoretical Domains Framework (TDF) that aims to reduce sedentary behaviour. The intervention consists of one individualized face-to-face session and 3 subsequent weekly points of contact (face-to-face meetings or phone calls).
~Behaviour change techniques will be provided including education, verbal persuasion, environmental restructuring and goal-setting."
15854711|NCT04004572|Drug|LEAP regimen|Patients will be given LEAP regimen every 3 weeks for 8 cycles.
15854712|NCT04004559|Other|No interventions|As this is a patient registry, there are no interventions.
15854713|NCT04004546|Behavioral|Health literacy-based intervention|Participants in the intervention group will receive a: i) 30-min video about medication adherence, ii) medication adherence booklet, and iii) 2-week telephone call by a nurse.
15854714|NCT04004533|Procedure|Endoscopic retrograde cholangiopancreatography (ERCP)|At the time of each ERCP procedure, information on procedure indication, technical performance of the duodenoscope and adverse events will be collected using a newly designed duodenoscope assessment tool. The duodenoscope assessment tool was developed to measure the technical performance of the duodenoscopes based on three components: passage and positioning at the papilla, performing requisite technical maneuvers and technical features. Each performance component is graded on a scale ranging from 1 to 5 (1 for easy maneuverability, 5 for most difficult maneuverability). Duodenoscope assessment tool also captures data on procedural indications, cannulation success rates and adverse events.
15854715|NCT04004520|Behavioral|Virtual Reality with Meditation|The Guided Meditation Virtual Reality is a mindfulness meditation app provided on a virtual reality platform that includes a 10 minute audio meditation for relaxation along with a 3D visualization of natural settings (e.g. forest, beach, mountain).
15854716|NCT04004520|Behavioral|Audio Control|The UCLA Mindful App is an audio only mindfulness meditation for relaxation called Breath, Sound, Body Meditation that is 12 minutes in length.
15854717|NCT04004520|Behavioral|Virtual reality Control|The Looking Glass Virtual Reality is a stereographic 3D photo viewer provided on a virtual reality platform featuring photos from around the world dating back to approximately a century ago that participants will view for 10 minutes.
15854718|NCT04004507|Drug|Phentolamine Mesylate Ophthalmic Solution 1%|Topical Sterile Ophthalmic Solution
15854719|NCT04004507|Other|Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)|Topical Sterile Ophthalmic Solution
15854720|NCT04004494|Other|3D reconstruction|3-dimensional computed tomography reconstruction guided VATS segmentectomy
15854721|NCT04004481|Drug|Postoperative analgesia using tramadol|Tramadol 100 mg will be given to the patients in the postoperative period.
15854722|NCT04004468|Behavioral|Resistance Training|Standard barbell resistance training programs
15854725|NCT04004429|Drug|50 mg AP1189|50 mg AP1189 powder in bottle
15854726|NCT04004429|Drug|AP1189|100 mg AP1189 powder in bottle
15854727|NCT04004429|Drug|Placebo|Placebo powder in bottle
15854728|NCT04004416|Other|Placebo and fMRI|A dose of Placebo will be given 90 minutes prior to entering the fMRI scanner. At each visit volunteers will complete assessments (blood draw, vitals, qols) prior to having an fMRI. Females may need to have this scheduled to coincide with a certain phase of their menstrual cycle. During the fMRI participants will be asked to view pleasant/unpleasant pictures and rate them while you are inside the scanner.
15854729|NCT04004416|Drug|Lorazepam and fMRI|A dose of Lorazepam (assigned to one of two dose levels between subjects: 0.01 mg/kg or 0.02 mg/kg) will be given 90 minutes prior to entering the fMRI scanner. At each visit volunteers will complete assessments (blood draw, vitals, qols) prior to having an fMRI. There will be two fMRIs done approximately 1 week apart and after the assessment visit. Females may need to have this scheduled to coincide with a certain phase of their menstrual cycle. During the fMRI participants will be asked to view pleasant/unpleasant pictures and rate them while you are inside the scanner.
15854730|NCT04004403|Other|Alternate day fasting|"The diet involves consuming 25% of their baseline energy needs on the fast day and eat ad libitum at home on alternating feed days."
15854731|NCT04004403|Other|Exercise|The exercise intervention involves supervised aerobic exercise program 5 times per week, 40-60 min per session.
15854732|NCT04004377|Other|Scale of quality life|"The PANQOL scale (Penn Acoustic Neuroma Quality-of-Life) is a specific questionnaire containing 26 items Interviewing 7 areas: hearing, balance, facial expression, anxiety, vitality, pain, and 'general health. The score is encrypted from 0 to 100, and the highest score is a reflection of the best possible quality of life. This score has been translated from French into English and validated according to the reverse translation rules by usual Oddon et al.
~Three questions for this score were added, evaluating quality of life parameters that seem particularly interesting: the first regarding the difficulties in driving, the second questioning the recovery of a normal life, and the third assessing difficulties in working life."
15854733|NCT04004364|Other|Coordinated Specialty Care (CSC)|CSC is an integrated and team-based treatment model for first episode psychosis elements include psychotherapy, supported employment and education, family education and support, and pharmacotherapy.
15854734|NCT04004338|Drug|Kyprolis|Patients receiving kyprolis (carfilzomib)
15854735|NCT04004325|Drug|FT-4101|FT-4101 will be supplied as active capsules and will be administered per the protocol defined frequency and dose level.
15854736|NCT04004325|Drug|FT-4101 placebo|FT-4101 placebo will be supplied as placebo capsule matching in size and color to all the active capsules and will be administered per the protocol defined frequency and dose level.
15854737|NCT04004325|Other|Deuterated Water|Deuterated water will be provided as individual ready-to-use, single dose bottles each containing 50 mL of deuterated water (70%).
15854738|NCT04004312|Radiation|Stereotactic Body Radiation Therapy (SBRT)|Shorter radiation therapy means that a higher dose will be offered. To limit side effects of exposure to a high dose, a medical device protecting the rectum will be used. The medical device to be used is called SpaceOAR hydrogel (device). The SpaceOAR hydrogel creates space between the rectum and the prostate, making it much less likely that the rectum is exposed to radiation. It is injected into place prior to the start of radiation treatment using a needle. Patients may be awake or asleep under local anesthesia for the procedure. SpaceOAR hydrogel is not painful, it remains stable during radiation therapy and then is gradually absorbed by the body over the course of approximately six months, once radiation therapy has been completed.
15854739|NCT04004299|Diagnostic Test|HCV RNA self-test|Self-test set including instruction manual (video available as well), finger prick device, tube and envelope to safely transport biological material. Patient takes capillary blood sample, collects it in the tube and sends the sample to the lab by regular post mail.
15854740|NCT04004273|Behavioral|Exercise|24 moderate-intensity exercise training sessions over six weeks (four times per week; ~50 min per session)
15854741|NCT04004260|Behavioral|Internet-based Cognitive Behavior Therapy|The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8-week long e-learning intervention, with new modules introduced weekly and assignments are given to practice techniques learned.
15854742|NCT04004247|Device|High Flow Nasal generator (AirVO2)|High Flow Nasal Oxygenation
15854743|NCT04004234|Drug|Manganese Chloride|Administered by inhalation at 0.2 or 0.4mg/kg/d once daily in a 3-week cycle
15854744|NCT04004234|Drug|nab-paclitaxel|Administered intravenously, 125mg/m2/d on day1 and day8 in a 3-week cycle
15854745|NCT04004234|Drug|Gemcitabine|Administered intravenously, 1g/m2/d on day1 and day8 in a 3-week cycle
15854746|NCT04004234|Drug|anti-PD-1 antibody|Administered intravenously, 2-4mg/kg on day 3 in a 3-week cycle
15854747|NCT04004221|Drug|Tislelizumab|200mg intravenously (IV) every 3 weeks(Q3W)
15854748|NCT04004208|Drug|Eylea (Aflibercept, BAY86-5321)|Solution in a sterile glass vial, Dose A, IVT injection.
15854749|NCT04004208|Procedure|Laser photocoagulation|Transpupillary conventional laser ablative therapy
15854750|NCT04004195|Drug|BAY2327949|A single oral dose of 30 mg BAY2327949 given as one 30 mg IR tablet (dose might be reduced to 15 mg for group 4 according to safety assessment team decision)
15854751|NCT04004182|Dietary Supplement|Fruit bar with addition of polyphenols|Fruit bar with addition of 600mg bilberry anthocyanins and 1200mg apple polyphenols
15854752|NCT04004169|Device|Stimulation-ON|Active neurostimulation from the NeuroPace RNS® System
15854753|NCT04004169|Device|Stimulation-OFF|No neurostimulation from the NeuroPace RNS® System
15854754|NCT04004156|Device|PerQdisc® Nucleus Replacement Device.|All patients that meet the inclusion/exclusion criteria will receive the PerQdisc® Nucleus Replacement Device.
15854755|NCT04004143|Other|No intervention|No intervention.
15854756|NCT04004130|Other|Ultrasound imaging|Ultrasound imaging of the lumbar spine/subarachnoidal space
15854757|NCT04004117|Drug|Fentanyl citrate solution sublingual|Solution of fentanyl citrate (DIN : 02384124 / 02240434 / 02385406) will be administered sublingually by syringe. The dose is 12,5 mcg.
15854758|NCT04004117|Drug|Placebo oral liquid|Placebo will consist in simple syrup (simple syrup B.P. - NPN: 00050121) administered sublingually with syringe.
15854759|NCT04004104|Diagnostic Test|Upright Exercise|Exercise is generally performed in the upright position.
15854760|NCT04004104|Diagnostic Test|Supine Exercise|Since HPS patients with orthodeoxia experience an improvement in their symptoms and oxygen levels when supine, the intervention will involve them performing exercise in the supine position.
15854761|NCT04004091|Biological|Spermine|Spermine is a polyamine. It is an organic molecule that is involved in cellular metabolism and development.
15854762|NCT04004078|Device|other antifungal agents,breathing machine|If treatment failure for patients in group A，group B，group C and group D，change other antifungal agents(Amphotericin B for Injection,25mg,North China Pharmaceutical Co., Ltd or Caspofungin Acetate for lnjection,50mg and 70mg Cancidas®). Mechanical ventilation((EVITA 4, Dräger Medical Equipment (Shanghai) Co.,Ltd) was adopte.Treatment failure was defined as no improvement or worse of clinical symptoms, laboratory data, requiring change of antifungal agents therapy.
15854763|NCT04004065|Drug|SRP-5051|SRP-5051 injection, for IV use
15854764|NCT04004052|Other|Ultrasound guided injection|
15854765|NCT04004052|Other|Transcutaneous Electrical Nerve Stimulation (TENS)|
15854766|NCT04004052|Other|Sham Transcutaneous Electrical Nerve Stimulation (TENS)|
15854767|NCT04004026|Other|Assesment|3-m backwards walk test, timed up and go test, 12-item MS Walking Scale, 2-min walk test, timed 25-foot walk test, 4-square step test.
15854768|NCT04004013|Dietary Supplement|Lifenol®|"Lifenol®, powdered extract obtained from female hops flowers (Humulus lupulus L.) standardized in 8-PN content (100 µg /day) + maltodextrin = 500 mg/capsule
~+ 1000 mg of calcium and 800 IU of vitamin D per day"
15854769|NCT04004013|Dietary Supplement|Placebo|"Maltodextrin = 500 mg/capsule
~+ 1000 mg of calcium and 800 IU of vitamin D per day"
15854770|NCT04004000|Drug|Losmapimod|"This main study includes a treatment period of approximately one year. Subjects will receive 15 mg of losmapimod twice daily given as two 7.5 mg tablets per dose by mouth; for a total of 4 pills or 30 mg daily. The study drug should be taken with food and the date and time of each dose taken recorded in the subject diary.
~Only subjects who participated in and completed all procedures for the main study (Week 60) will be eligible to participate in the extension.
~For the extension, subjects will receive 15 mg of losmapimod by mouth twice daily for a total of 30 mg by mouth daily. Participation will continue until losmapimod is approved, the subject withdraws from the study, or the Sponsor terminates the study."
15854771|NCT04003987|Drug|Liposomal bupivacaine|20ml
15854772|NCT04003987|Drug|bupivacaine, 0.125%|60ml
15854773|NCT04003974|Drug|Losmapimod|This study includes a 48 week treatment period. Patients will receive Losmapimod 15 mg twice daily given as two 7.5 mg tablets per dose by mouth; for a total of 4 pills or 30 mg daily. The study drug should be taken with food and the date and time of each dose taken recorded in the subject diary.
15854774|NCT04003974|Drug|Placebo oral tablet|This study includes a 48 week treatment period. Patients will receive Placebo twice daily given as two 7.5 mg tablets per dose by mouth; for a total of 4 pills or 30 mg daily. The placebo tablets are identical to the Losmapimod tablets. Placebo should be taken with food and the date and time of each dose taken recorded in the subject diary.
15854775|NCT04003961|Other|STOP- BANG Questionnaire and Epworth sleepiness scale|STOP- BANG Questionnaire and Epworth sleepiness scale will be filled in maximum 10 minutes
15854776|NCT04003948|Drug|Ibogaine Hydrochloride|Fixed or ascending doses of ibogaine will be administered for the treatment of opioid withdrawal syndrome.
15854777|NCT04003935|Other|Juice Plus+ Complete|Plant-based smoothie; maintaining habitual diet.
15854778|NCT04003935|Dietary Supplement|Juice Plus+ Premium|Fruit and vegetable juice concentrate; maintaining habitual diet.
15854779|NCT04003922|Other|Adalimumab treatment|Retrospective observational study initially and then prospective with inclusion of all the patients carrying an ER treated by Adalimumab in France. Follow-up will continue for one year if adalimumab is discontinued.
15854780|NCT04003909|Procedure|ultrasound-guided Erector spinae plane block|The patients will be in lateral position. A curvilinear array ultrasound probe will be placed in a transverse orientation at L4 level to identify the tip of the L4 transverse process. Local anesthetic infiltration of the superficial tissues, an echogenic 22-G block needle will be inserted inplane to the ultrasound beam in a cranial-to-caudal direction until contact made with the L4 transverse process. Correct location of the needle tip in the fascial plane deep to erector spinae muscle will be confirmed by injecting 0.5-1ml saline and seeing the fluid lifting the erector spinae muscle off the transverse process while not distending the muscle. A total volume of 20ml bupivicaine 0.25% and 20 ml xylocaine 1% will be injected into the ESP on the affected side.
15854781|NCT04003909|Procedure|subarachonoid block|Local anesthesia 2ml of lidocaine 2% will be applied intradermally to the needle entrance point. A 22-G block needle will be inserted, free cerebrospinal fluid flow will be observed and 20mg of hyperbaric bupivacaine 0.5% and 10μg of fentanyl will be injected for 30 seconds.
15854782|NCT04003896|Drug|Abemaciclib|"Participant will take 200 mg capsules or tablets orally twice daily. The participant will be instructed to swallow abemaciclib as a whole tablet and not to chew, crush or split capsules or tablets before swallowing. Participants should not ingest abemaciclib tablets if broken, cracked, or otherwise not intact. Doses should be taken at a approximately the same time every day, twice daily. Capsules or tablets can be taken orally with or without food. If the participant vomits or misses a dose of abemaciclib, the participant will be instructed to take the next dose at its scheduled time.
~Participants will also be provided with a diary and instructed to keep a twice daily record of the times they have taken their medications and any other events such as vomiting, diarrhea, etc."
15854783|NCT04003883|Device|Holter ECG|A Holter ECG will be recorderd during shifts
15854784|NCT04003870|Device|CASO|Customized arch support orthoses (CASO)
15854785|NCT04003870|Device|HL|Orthotic Heel Lift (HL)
15854786|NCT04003857|Biological|PNEUMOSTEM®|A single intratracheal administration of PNEUMOSTEM® (1.0 x 10^7 cells/kg)
15854787|NCT04003857|Biological|normal saline|A single intratracheal administration of normal saline
15854788|NCT04003844|Drug|Immunoglobulin G|single dose of IGIV 10% (2 g/kg) administered intravenously for at least 12 hours
15854789|NCT04003844|Drug|Acetylsalicylic acid|Coadministration
15854790|NCT04003831|Device|Device: P200TxE|The P200TxE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.
15854791|NCT04003818|Drug|TEICOPLANIN|Pharmaceutical form:solution for oral administration Route of administration: oral
15854827|NCT04003571|Behavioral|Augmented Reality with Functional Electrical Stimulation group|Experimental group contains 30 minutes augmented reality combined with functional electrical stimulation training, and 30 minutes traditional physiotherapy. Augmented reality includes treadmill and balance exercise. Functional electrical stimulation applies on tibialis anterior muscle. Traditional physiotherapy includes rolling, sitting, standing, overground walking, facilitation of the paretic limbs, and so on.
15854792|NCT04003805|Drug|Standardized Research E-cigarette (SREC)|The device operates at a single output voltage (3.30 ± 0.05 V) and uses sealed disposable 3-mL cartridges with tobacco-flavored e-liquid (~350 puffs/cartridge). The concentration of nicotine in e-liquid is 15 mg/mL, and the vehicle composition is 50:50 propylene glycol and glycerin. The device uses a battery that can be recharged via a micro USB port. A single charge is designed to sustain more than 400 puffs, which is more than the capacity of an e-liquid cartridge. The e-liquid and the aerosol are well-characterized in terms of chemical impurities and by-products (such as aldehydes), which are minimal. Additional information, including the results of pharmacokinetics study is available via NIDA website: https://www.drugabuse.gov/funding/supplemental-information-nida-e-cig
15854793|NCT04003805|Drug|Nicotine Mini-Lozenge|We will use commercially available nicotine mini-lozenges containing 2 or 4 mg nicotine/lozenge (Nicorette, manufactured by GlaxoSmithKline). Dose will be determined per instructions on the package (e.g, if smoking within 30 minutes upon awakening, then 4 mg dose will be prescribed).
15854794|NCT04003792|Drug|oxaliplatin|intra-arterial oxaliplatin administration
15854795|NCT04003792|Drug|FOLFIRI Protocol|systemic FOLFIRI chemotherapy
15854796|NCT04003792|Drug|Bevacizumab|systemic bevacuzimab therapy
15854798|NCT04003766|Diagnostic Test|biopsy|Liver biopsy (LB) is essential for the diagnosis and evaluation of a variety of hepatic conditions, such as grading/staging of chronic liver disease secondary to alcohol, non-alcoholic steatohepatitis, viral hepatitis, hemochromatosis, Wilson's disease, cholestatic liver disease, as well as in elucidating the etiology of elevation in liver tests.
15854799|NCT04003753|Other|VR App|Participants will be exposed in three different virtual height scenarios (rural mountain, urban town, cloudy weather). At the beginning of each exposure session participants will be standing on a virtual platform at ground level (level 0). From level 0 they will proceed to further levels according to a predefined exposure scheme based on SUDS ratings (scale 0=no fear to 10=extreme fear). Participants will have to stay at each level until their SUDS are 3 or below for two times consecutively (assessment via gaze selection). In each scenario there will be 15 different height levels available (corresponding to a range of heights between 1-75m). Each exposure session will be terminated by a time limit of 20 minutes (study phase 1) or 30 minutes (study phase 2) irrespective of achieved level.
15854800|NCT04003740|Device|Home-based transcranial direct current stimulation|The stimulation protocol will include one daily stimulation during the first 4 weeks, 2 weekly stimulations for the next 4 weeks, and one weekly stimulation over the last 4 weeks.
15854801|NCT04003727|Device|Mcgrath Mac Videolaryngoscope|Patient's laryngoscopy will be done using McGrath Mac video laryngoscope
15854802|NCT04003714|Device|Repetitive Transcranial Magnetic Stimulation|Patients in r-TMS group received 5 Hz of r-TMS. R-TMS applied with MagVenture device (MagPro X100, Denmark, 2009) and figure eight coil (MMC 140 parabolic, MagVenture).
15854803|NCT04003714|Device|Sham Repetitive transcranial Magnetic Stimulation|Control group received sham r-TMS.
15854804|NCT04003701|Behavioral|Usual care|Control group: minimal distraction
15854805|NCT04003701|Behavioral|Robot-assisted puncture procedure|Experimental group: distraction with robot
15854806|NCT04003688|Drug|Magnesium sulfate through real weight group|Magnesium sulfate dose 40 mg/kg of actual patient's weight
15854807|NCT04003688|Drug|Placebo group|Saline solution (instead of magnesium sulfate, as in the other groups)
15854808|NCT04003688|Drug|Magnesium sulfate through ideal corrected weight group|Magnesium sulfate dose 40 mg/kg of ideal corrected patient's weight
15854809|NCT04003662|Device|Vital Signs Measurement|Vital signs are measured twice with standard of care equipment while recording digital video data at the same time.
15854810|NCT04003649|Biological|IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells|Given ITV/ITC
15854811|NCT04003649|Biological|Ipilimumab|Given IV
15854812|NCT04003649|Biological|Nivolumab|Given IV
15854813|NCT04003649|Other|Quality-of-Life Assessment|Ancillary studies
15854814|NCT04003649|Other|Questionnaire Administration|Ancillary studies
15854815|NCT04003636|Biological|Pembrolizumab|Pembrolizumab by intravenous (IV) infusion
15854816|NCT04003636|Drug|Gemcitabine|Gemcitabine by IV infusion
15854817|NCT04003636|Drug|Cisplatin|Cisplatin by IV infusion
15854818|NCT04003636|Drug|Placebo|Placebo to pembrolizumab
15854819|NCT04003623|Drug|Pemigatinib|Pemigatinib administered orally once daily.
15854820|NCT04003610|Drug|Pemigatinib|Pemigatinib at the protocol-specified dose administered orally.
15854821|NCT04003610|Drug|Pembrolizumab|Pembrolizumab at the protocol-specified dose administered intravenously.
15854822|NCT04003610|Drug|Gemcitabine|Gemcitabine at the protocol-specified dose administered intravenously with carboplatin.
15854823|NCT04003610|Drug|Carboplatin|Carboplatin at the protocol-specified dose administered intravenously with gemcitabine.
15854824|NCT04003597|Other|Usual-salt diet|Subjects followed their usual-salt diet but were asked to consume an equivalent in-house produced brown or white sliced pan bread equivalent in composition to the low-salt version but with its more typical salt content (1.2 g/100 g).
15854825|NCT04003597|Other|Reduced-salt diet|Subjects randomized to start on the reduced-salt diet were asked to restrict their consumption of dietary salt using a combination of pragmatic dietary advice as well as the replacement of bread and a limited number of other foods with equivalent foods which had lower salt content; these were provided to the participants. At the beginning of the salt restriction period, a research nutritionist provided the subjects with a list of the common salt-containing food (salted and naturally salty) and were asked to limit the consumption of such, as feasible. The subjects received in-house prepared 'low-salt (<0.3 g/100 g)' brown or white sliced pan bread as well as no-salt margarine/butter, and were given luncheon meats with no added salt if desired (optional).
15854826|NCT04003584|Procedure|Coronary bypass surgery|Reviewed postoperative coronary bypass patients and compared postoperative pain levels
15854828|NCT04003571|Behavioral|Traditional physiotherapy|Traditional physiotherapy includes treadmill and balance training for 30 minutes as well as rolling, sitting, standing, overground walking, facilitation of the paretic limbs for another 30 minutes .
15854829|NCT04003558|Other|No interventions|As this is a patient registry, there are no interventions.
15854830|NCT04003545|Radiation|LED Photobiomodulation|A total of twelve laser applications (3 sessions per week) will be provided to the patients as treatment. A LED board with wavelengths of 660nm and 850nm at 5mW of power will be used for 30 minutes, resulting in a total energy of 3J per point in each session. The application site will be the lumbar region, in contact with the skin. The LED cluster (light-emitting diodes) has 72 LEDs.
15854831|NCT04003545|Other|Placebo LED Photobiomodulation|For the placebo group, the procedures will be the same, however the LED equipment will remain off.
15854834|NCT04003493|Other|Nutrition and oral health intervention|The interventions included individualised nutrition and oral health care.
15854835|NCT04003480|Device|FRAME|External support for vein grafts in peripheral bypass surgery
15854836|NCT04003467|Drug|EBP05|tablets
15854837|NCT04003467|Drug|Placebo of EBP05|tablets
15854838|NCT04003454|Other|HCV Screening|The investigators will perform a prospective pragmatic randomized effectiveness trial that will allow the investigators to directly compare 2 HCV screening methods while minimizing threats to internal validity. Patients will be screened for HCV infection using 1 of 2 interventions using a balanced patient-level random allocation scheme built into existing EHRs for each ED.
15854839|NCT04003441|Drug|DWP14012 tablet A|Period 1: DWP14012 tablet B Period 2: DWP14012 tablet A
15854840|NCT04003441|Drug|DWP14012 tablet B|Period 1: DWP14012 tablet A Period 2: DWP14012 tablet B
15854841|NCT04003428|Device|High Intensity Focused Ultrasound|HIFU shots will be performed on the placental tissue to produce necrotic lesions of approximately 30% of the total volume. A latency time of 2 minutes between each shot will be observed to avoid the accumulative heat effect, and to ensure optimal positioning of the treatment probe. The maximum duration of the operating time for HIFU shooting shall not exceed 60 minutes.
15854842|NCT04003415|Device|Investigational Device: Contactless heart rate and respiratory rate monitor|Participant will be seated next to the investigational device. The device is contactless, and will measure the patient's heart rate and respiratory rate through use of radio-waves.
15854843|NCT04003415|Diagnostic Test|Heart Rate (EKG) Monitor|Participant will undergo 3-lead EKG testing to measure heart rate during testing.
15854844|NCT04003415|Diagnostic Test|Respiratory rate Monitor|Participant will have an elastic band around their chest for monitoring respiratory rate during testing.
15854845|NCT04003415|Diagnostic Test|Pulse Oximetry|Participants will wear a finger pulse oximeter during the testing for monitoring of heart rate, respiratory rate, and pulse oximetry.
15854846|NCT04003402|Drug|ASP8062|oral
15854847|NCT04003402|Drug|Alcohol|oral
15854848|NCT04003402|Drug|ASP8062 Placebo|oral
15854849|NCT04003402|Drug|Alcohol Placebo|oral
15854850|NCT04003389|Drug|fezolinetant|administered orally
15854851|NCT04003389|Drug|placebo|administered orally
15854852|NCT04003376|Device|fractional carbon dioxide laser alone|six sessions of fractional carbon dioxide laser will be done for alopecia areata lesions
15854853|NCT04003376|Drug|Triamcinolone Acetonide 10mg/mL|six sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata followed immediately by topical application of triamcinolone acetonide
15854854|NCT04003376|Biological|platelet rich plasma|six sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata followed immediately by topical application of autologous platelet rich plasma
15854855|NCT04003376|Drug|vitamin D solution|six sessions of fractional carbon dioxide laser will be done for 10 patients with alopecia areata followed immediately by topical application of vitamin D solution
15854856|NCT04003363|Other|Patient Registry|Participants who have volunteered to participate will complete various questionnaires relating to their condition.
15854857|NCT04003350|Drug|Oxycodone|Patients are given, for up to 4 weeks, Oxycodone 5m PRN every four hours (up to 30 tablets)
15854858|NCT04003350|Drug|Tramadol|Patients are given, for up to 4 weeks, Tramadol 50mg PRN every 6 hours (up to 30 tablets)
15854859|NCT04003350|Drug|Tylenol|Tylenol 1000 mg: take as needed every 8 hours
15854860|NCT04003350|Drug|Meloxicam|Meloxicam 15 mg as need once per day
15854861|NCT04003350|Drug|Gabapentin|•Gabapentin 200 mg with morning and evening Tylenol dose
15854862|NCT04003350|Drug|Metaxalone|Metaxalone 800mg TID
15854863|NCT04003350|Drug|Esomeprazole 20mg|Esomeprazole 20mg daily
15854864|NCT04003337|Other|Morpho-kinetics selection with time-lapse (Embryoscope) evaluation|Embryos in group B will be selected in blastocyst stage according to morpho-kinetics criteria before the embryo transfer
15854865|NCT04003324|Behavioral|Op is Top - using feedback from the Activator to reduce sedentary behavior in older adults|Participants will receive a self-monitoring tool (i.e. the Activator) aimed at the reduction of sedentary behavior. Participants will be able to use the self-monitoring tool for four weeks. Apart from that, participants will receive general sedentary behavior information and an explanation on how to use the self-monitoring tool.
15854866|NCT04003311|Device|Comprehensive Primary Micro Stem|Patient that have been implanted with the comprehensive primary micro stem to repair shoulder malfunction/disease
15854867|NCT04003298|Device|Electric toothbrush|Electric toothbrush and power interdental device
15854868|NCT04003298|Device|Control|Oscillating-rotating
15854869|NCT04003285|Drug|Placebo|ALLO 0 nM (placebo: loading dose, 4-hour infusion, taper)
15854870|NCT04003285|Drug|Allopregnanolone|ALLO 50 nM (lower dose ALLO: loading dose, 4 hour infusion, taper)
15854871|NCT04003285|Drug|Allopregnanolone|ALLO 150 nM (higher dose ALLO: loading dose, 4 hour infusion, taper)
15854872|NCT04003272|Device|Comprehensive Reverse Versa-Dial Titanium Glenosphere|Implant used for patients with allergy to typical device material metals to repair shoulder malfunction/disease.
15854914|NCT04002934|Drug|Bazedoxifene Acetate|40 mg Bazedoxifene delivered orally in the form of 2x 20 mg blinded capsules
15854873|NCT04003259|Behavioral|Lifestyle management programme|The programme consisted of 1) the initiation phase (1-3 months), 2) the establishment phase (3-6 months), and 3) the maintenance phase (7-12 months). Guidance was given altogether on 25 separate occasions with special emphasis on the motivation and education. The goal for weight loss was 5-10 %. The programme included four visits by medical doctor, an educational lecture by medical doctor and personal trainer, five sessions by registered dietician, two cooking classes by professional chef, two group discussions, and exercise as follows: personalized exercise program tailored by personal trainer, one-year gym access with four guided group sessions, and two guided group Nordic walking sessions, and three individual exercise sessions by personal trainer.
15854874|NCT04003246|Radiation|Thoracic RT and Durvalumab|1500mg every 4 weeks [Q4W] intravenous [IV], first dose within 3 days of RT initiation
15854875|NCT04003246|Drug|Consolidative Durvalumab|1500mg every 4 weeks [Q4W] intravenous [IV] up to one year
15854876|NCT04003233|Device|SDS|The SDS will be added to a traditional growing rod (TGR) of 4.5 or 5.5mm.
15854877|NCT04003233|Device|MID-C|The MID-C system consists of a unilateral one-way ratchet rod that is connected to the spine with polyaxial connectors
15854878|NCT04003220|Procedure|blood sample|The extra samples will be taken Blood sampling
15854879|NCT04003220|Procedure|Bone marrow sample|This bone marrow sampling will be performed for 10 patients with ICTUS, and 10 controls
15854880|NCT04003207|Drug|Recombinant human Growth hormone|Subcutaneous growth hormone injections given once daily at a dose between 0.15mg/kg/week to 0.47 mg/kg/week titrated based on IGF-1 levels in serum for a duration of 12 weeks.
15854881|NCT04003194|Other|Pinto Beans|The intervention was 1/2 cup of pinto beans each day.
15854882|NCT04003194|Other|Green Beans - control|The control was 1/2 cup of green beans each day.
15854883|NCT04003181|Drug|Antibiotics|Ciprofloxacin or Rifaximin for 10 days.
15854884|NCT04003181|Drug|Bile Acid Binder|Cholestyramine or Colesevelam lifelong.
15854885|NCT04003168|Drug|Human BCMA targeted T Cells Injection|Autologous genetically modified anti-BCMA CAR transduced T cells
15854886|NCT04003155|Drug|fezolinetant|administered orally
15854887|NCT04003155|Drug|placebo|administered orally
15854888|NCT04003142|Drug|fezolinetant|administered orally
15854889|NCT04003142|Drug|placebo|administered orally
15854890|NCT04003129|Other|questionnaire|"Data will be obtained through a written questionnaire for assessing knowledge, practice and attitude of paediatricians regarding early childhood caries.
~Data collected will be saved and tabulated on computer and finally statistically analysed."
15854891|NCT04003116|Drug|Oxygen gas|Supplementary oxygen during the first 48 hours added to conventional anticoagulant treatment. Patients will receive anticoagulant treatment according to updated guidelines.
15854892|NCT04003103|Drug|Islatravir|Islatravir administered orally in capsule form swallowed whole once monthly for 24 weeks
15854893|NCT04003103|Drug|Placebo|Placebo for islatravir administered orally in capsule form swallowed whole once monthly for 24 weeks
15854894|NCT04003090|Drug|Citicoline|After treatment with a solution containing citicoline 1% eye-drops, 0.2% high molecular weight hyaluronic acid and 0.01% benzalkonium chloride patients underwent a 23G standard 3-port pars plana vitrectomy. The vitreous sample was taken at the beginning of the surgery and then analyzed.
15854895|NCT04003077|Device|laser meridian massage|The participants will undergo 12 sessions of laser meridian massage, thrice a week, for 4 weeks, using a gallium aluminum arsenide LaserPen (maximal power, 150 mW; wavelength, 810nm; area of probe, 0.5cm^2; power density, 300mW/cm^2; pulsed wave; RJ-Laser, Reimers & Janssen GmbH, Waldkirch, Germany). The laser treatment will be applied to the back including Bladder meridian (BL11-25) and Governor vessel (GV3-14) for 15 minutes, to deliver a total treatment dose of 67.5J/cm^2.
15854896|NCT04003064|Diagnostic Test|Blood|3ml blood
15854897|NCT04003051|Other|Internet-Based Intervention|Use Project Prepare website
15854898|NCT04003051|Other|Quality-of-Life Assessment|Ancillary studies
15854899|NCT04003051|Other|Questionnaire Administration|Ancillary studies
15854900|NCT04003038|Procedure|Negative Pressure Wound Therapy|Receive wound care with NPWT
15854901|NCT04003038|Procedure|Wound Care Management|Receive wound care with a standard dressing (bandage)
15854902|NCT04003012|Drug|EMLA|EMLA cream (lidocaine 2.5% and prilocaine 2.5%)
15854903|NCT04003012|Drug|Lidocaine|lidocaine 1%
15854904|NCT04002999|Device|3D printed ceramic bracket and tray|The 3D ceramic bracket being investigated is the only available customized ceramic bracket. This will be a first for the orthodontic speciality. This will also be the first and only customized bracket system that includes customization of the bracket base. This helps in the control of first order orthodontic movements and allows brackets to be bonded on any labial surface of the tooth while maintaining an ideal prescription. As 3D printing is not limited by the mold-ejection in CIM, [24] the bracket system being tested here has the potential to achieve a more accurate slot dimension.
15854905|NCT04002999|Device|Stock ceramic bracket + 3D printed tray|Traditionally, indirect bonding, starts with creating a mold of all the teeth as an exact replica of the mouth of the patient. From there, in the lab, the orthodontist positions each bracket precisely where it should go on each tooth and then creates a custom tray that allows transfer of the brackets from the lab model to the patient's teeth. By taking the time to place the brackets in a proper position on the lab model, orthodontists eliminate the inaccurate process of placing orthodontic brackets directly on the teeth. It theoretically also takes less chairside time and is more comfortable for the patient. It is however more technique sensitive. In this study, indirect bonding setup will be done virtually using commonly-available orthodontic software. The trays/jigs will then be 3-D printed
15854906|NCT04002999|Device|Stock bracket, no tray|Direct bonding is the traditional way of placing orthodontic brackets, in which orthodontists clinically eyeball the tooth and place the bracket where they deem most appropriate
15854907|NCT04002986|Genetic|Genetic Testing|A blood draw or saliva kit will be provided to collect subject cells
15854908|NCT04002973|Device|INVSENSOR00037|Noninvasive regional oximeter.
15854909|NCT04002960|Device|INVSENSOR00036|Noninvasive regional oximeter
15854916|NCT04002869|Diagnostic Test|Immunologic, molecular, metabolomic and radiolologic diagnostic|Evaluation and development of new technologies
15854917|NCT04002856|Device|Profhilo®|Profhilo® (IBSA Farmaceutici Italia S.r.l.) is a resorbable medical device 2.25 ml non-pyrogenic pre-filled syringe, containing 2 ml of 3.2% hyaluronic acid for intradermal use (32 mg H-HA + 32 mg L-HA dissolved in 2 ml of saline buffered sodium chloride
15854918|NCT04002843|Other|paraclinical evaluation of single fibre|ENMG 5 channel Digital EMG, NCS and EP System, Neurosoft, Skybox. Amplification of the EMG signal BF 500 Hz, HF 3kHz, mains filter at 50 Hz. Acquisition at 2 ms at 100 µv, parameters can be modified. The single-use needle electrode (Neuroline Concentric, Neurology Needle Electrode; 25x0.30 mm(1''x30G)) of reference inserted into one elbow flexor muscle (biceps brachialis, anterior brachialis) on the parietal side with location of the ground reference. The paroetic arm will be supported by the evaluator in order to generate a minimal tone, necessary for the occurrence of potential actions of two muscle fibres present within the same motor unit.
15854919|NCT04002830|Drug|Elelyso|Taliglucerase alfa is currently an approved therapy in the United States and many other countries for adults and children with a confirmed diagnosis of Type 1 GD ,and is also approved for use in Type 3 GD in a small number of countries.
15854920|NCT04002804|Biological|Dendritic Cells Vaccine|"Right after the surgical resection of the recurrent tumor, leukapheresis will be performed.
~At least 5x109 PBMC must be collected by leukapheresis, so as to make the whole immunotherapy schedule workable.
~Starting at week 3, immunotherapy will include 4 bi-weeekly vaccinations first (injections I, II, III, IV), two further monthly vaccinations (injections V, VI) and a final vaccination (injection VII) two months after the sixth one. Injections I, V, VI and VII will contain 10 million tumor lysate-loaded DC, while the others will be of 5 million cells only.
~Vaccine doses will be injected in the forearm of the patient."
15854921|NCT04002791|Device|VasoBand|Dual-bladder radial artery hemostatic compression device capable of ipsilateral ulnar artery compression
15854922|NCT04002778|Diagnostic Test|Fine needle aspiration|
15854923|NCT04002778|Diagnostic Test|Rapid on-site evaluation|
15854924|NCT04002765|Diagnostic Test|pulmonary function tests|"Lung function tests (standard of care)
~Dynamic and static volumes (FVC, FEV1, TPC, RV)
~Lung diffusion capacity for CO (DLCO)
~Chest Xrays
~High resolution CT scanner (HRCT)"
15854925|NCT04002752|Drug|JNJ-73763989|Participants will receive JNJ-73763989 as single subcutaneous injection.
15854926|NCT04002752|Drug|Placebo|Participants will receive placebo matching to JNJ-73763989 as single subcutaneous injection.
15854927|NCT04002739|Diagnostic Test|Polygraphy|Patients will perform polygraphy during the CCU stay (baseline) and, if found to have a diagnosis of Obstructive Sleep Apnea (OSA) syndrome, will complete the study with a follow-up visit at 90-day (follow-up). Diagnosis of OSA syndrome will require an Apnea / Hypopnea Index (AHI) more than 5 events per hour.
15854928|NCT04002726|Other|Inter-grader agreement (IGA) app|A smartphone-based app with images of conjunctivae for trachoma grading training purposes.
15854929|NCT04002713|Other|ALT flap reconstruction|Patients who underwent ALT free flap reconstruction after head and neck cancer surgery.
15854930|NCT04002713|Other|AMT flap reconstruction|Patients who underwent AMT free flap reconstruction after head and neck cancer surgery.
15854931|NCT04002700|Drug|Haloperidol|Stroke rates among participants from 01 January, 2002 through 31 December 2017 will be estimated among new users of haloperidol. No drug will be administered as part of this study.
15854932|NCT04002700|Drug|Typical Antipsychotics|Stroke rates among participants from 01 January, 2002 through 31 December 2017 will be estimated among new users of typical antipsychotics which includes Haloperidol, Loxapine, Thioridazine, Molindone, Thiothixene, Fluphenazine, Trifluoperazine, Perphenazine, Chlorpromazine. No drug will be administered as part of this study.
15854933|NCT04002700|Drug|Atypical Antipsychotics|Stroke rates among participants from 01 January, 2002 through 31 December 2017 will be estimated among new users of atypical antipsychotics which includes Aripriprazole, Asenapine, Brexpiprazole, Cariprazine, Clozapine, Iloperidone, Lurasidone, Paliperidone, Ziprasidone, Risperidone, Quetiapine, Olanzapine. No drug will be administered as part of this study.
15854934|NCT04002687|Drug|ATV-PG 1000-400 mg + AQ 612 mg|The dosing will be carried out by an unblinded member of the investigator's staff. Dosing will take place behind a curtain and during IMP administration the subjects will be blindfolded. ATV-PG (or placebo) will always be given first, then AQ (or placebo).
15854935|NCT04002674|Drug|Placebo oral capsule|"Thirty (30) patients in arm 1 will receive the matching placebo (sugar pill) one (1) capsule orally (without food) once daily for 6 months (180 days)."
15854936|NCT04002674|Drug|Nilotinib Oral Capsule|Thirty (30) patients in arm 2 will receive the 200 mg of Nilotinib one (1) capsule orally (without food) once daily for 6 months (180 days).
15854937|NCT04002661|Drug|Flibanserin|Flibanserin tablet
15854938|NCT04002661|Drug|Placebo|Oral Tablet
15854939|NCT04002648|Procedure|Right minithoracotomy|Incision of the right chest between 3rd and 4th or 4th and 5th intercostal space
15854940|NCT04002648|Procedure|Sternotomy|Longitudinal resection of the sternum
15854941|NCT04002635|Drug|Letrozole|Letrozole ovulation induction
15854942|NCT04002635|Drug|estradiol valerate|hormonal replacement therapy
15854943|NCT04002622|Drug|TQB2450|TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
15854944|NCT04002609|Other|oxygen|oxygen supplementation during brronchoscopy
15854945|NCT04002596|Device|ExAblate Neuro Thalamotomy Treatment|Non-invasive Focused Ultrasound Ablation of Thalamus Vim nucleus using ExAblate MRgFUS system for treatment Tremor Dominant Parkinson Disease
15854946|NCT04002583|Diagnostic Test|Computer assisted ambulatory electroencephalogram|A portable 16 channel CAA-EEG is used to detect epileptiform abnormalities in a 48 hour ambulatory electroencephalogram (EEG)
15854947|NCT04002570|Other|blood samples collection|blood samples collection are performed at 4 different timepoints: preop, pre rt, week 6 rt, week 12-14 (fu) for GROUP I and GROUP II; blood samples collection are performed at 3 different timepoints: pre rt, week 6 rt, week 12-14 (fu) for GROUP I bis; blood samples collection are performed just once for control GROUP.
15854948|NCT04002557|Other|No intervention|Interviews contain no intervention, purely observational.
15855045|NCT04001946|Device|Button Huggie|low profile, external securement device for G-buttons
15854949|NCT04002544|Drug|NTG patch|A half-NTG patch (dose calculated at 5-12.5 mcg/kg/hr) will be applied to patients at the site of radial pulsation one hour before induction of anesthesia. The NTG patch will be applied to the right upper in half of the patients and will be applied to the left upper limb in the other half
15854950|NCT04002544|Other|gauze cover|A gauze will be applied near the radial artery pulsation to ensure blinding
15854951|NCT04002531|Other|General and Neurological examination|Information about your general health, neurological symptoms and current medications with be collected
15854952|NCT04002531|Other|Vital signs|Height, weight, blood pressure, heart rate, and respiratory rate and temperature will be measured.
15854953|NCT04002531|Procedure|12 lead electrocardiogram|A non-invasive test that measures the electrical activity of the heart
15854954|NCT04002531|Procedure|Echocardiogram|A non-invasive sonogram of the heart
15854955|NCT04002531|Procedure|Blood draw|Blood will be drawn to evaluate general health and renal function (kidney health)
15854956|NCT04002531|Procedure|Urine collection|Urine will be collection to evaluate renal function (kidney health)
15854957|NCT04002531|Procedure|2-hour Holter Monitor|A non-invasive test that measures the electrical activity of the heart continuously over 2 hours
15854958|NCT04002531|Other|Brief Pain Inventory questionnaire|A questionnaire about daily pain
15854959|NCT04002531|Other|Quality of Life questionnaire|A questionnaire about the impact of disease on their activities of daily living and quality of life
15854960|NCT04002518|Device|Biomet Cannulated Screw: 3.0, 4.0, 5.0, 6.5, and 8.0mm screws.|Treatment of identified conditions, i.e. fracture fixation, arthrodesis, osteotomy, with a cannulated screw.
15854961|NCT04002505|Other|Concussion and Brain Bleed App (CBB)|Tablet based decision aid that encourages shared decision making with the goal of educating patients to reduce unnecessary CT scans
15854962|NCT04002492|Behavioral|Bodyweight training|Video guided and physical therapist guided bodyweight training sessions will be performed twice a week for 6 (to 8) weeks. These sessions include the following five workouts at 3 sets of 10 repetitions: step ups, calf raises, wall push ups, chair squats, and chair dips.
15854963|NCT04002479|Device|Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)|An intratumoral insertion of radioactive sources [Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)]. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.
15854964|NCT04002466|Other|Risk factors for anemia|Diet, iron, vitamin B12, folate, inflammation, soil transmitted helminth infection, malaria, other morbidities and other health/nutrition/sociodemographic factors
15854965|NCT04002453|Procedure|Outpatient Parenteral Antibiotic Therapy|Application of outpatient parenteral antibiotic therapy in patients with infectious diseases to allow them to get discharged from hospital.
15854966|NCT04002440|Combination Product|AMIA with SHARESOURCE Connectivity Platform|The investigators will conduct a randomized, cross-over study in peritoneal dialysis patients in which patients are randomized to either Home Choice Pro (which remains the most widely used Baxter cycler) versus treatment with the Baxter AMIA automated peritoneal dialysis system with SHARESOURCE connectivity.
15854967|NCT04002440|Device|HomeChoice PRO|Usual care
15854968|NCT04002427|Drug|Intravenous Infusion|30 µg [14C]AZD7594 containing 6.7 kBq (180 nCi) carbon-14 (14C) as a 1 hour infusion.
15854969|NCT04002427|Drug|Inhaled dose|A single inhalation on one occasion.
15854970|NCT04002414|Behavioral|Sufficient physical activity|Physical activity at the recommended levels by the US Health and Human Services Department: 75 minutes a week of vigorous activity or 150 minutes a week of moderate activity.
15854971|NCT04002414|Behavioral|Insufficient physical activity|Physical activity less than the recommended levels by the US Health and Human Services Department: 75 minutes a week of vigorous activity or 150 minutes a week of moderate activity.
15854972|NCT04002401|Biological|Axicabtagene Ciloleucel|A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously
15854973|NCT04002401|Drug|Rituximab|Administered intravenously
15854974|NCT04002401|Drug|Fludarabine|Administered according to package insert
15854975|NCT04002401|Drug|Cyclophosphamide|Administered according to package insert
15854976|NCT04002388|Behavioral|activity monitor group|will receive a FitBit and will be asked to wear this for one year
15854977|NCT04002388|Behavioral|usual care group|will NOT receive a FitBit
15854978|NCT04002375|Other|pectouteropexy|The surgical procedure was initiated after adhesiolysis had been performed by opening the peritoneal layer along the round ligament toward the pelvic side wall. Preparation started at the right external iliac vein and was performed in the medial and caudal direction. A segment of area approximately 3- 4 cm2 of the right lateral part of the iliopectineal ligament (Cooper ligament) adjacent to the insertion of the iliopsoas muscle was exposed.The peritoneum of the bladder was dissected, and the anterior parts of the distal uterus were prepared for mesh fixation. The uterus was elevated to the intended tension-free position using the transvaginal probe (POP-Q level 0-1). The mesh was fixed anteriorly to the cervix using four polyester permanent sutures (Ethibond Excel®; Ethicon). Finally, the mesh was covered with peritoneum using a continuous monofilament absorbable suture (Maxon™; Medtronic).
15854979|NCT04002362|Drug|Triamcinolone Acetonide|An intramuscular injection of triamcinolone acetonide (1 mg/kg, up to 40 mg maximum) will be administered deep in the gluteal muscle by a trained registered nurse.
15854980|NCT04002349|Drug|Budesonide Nasal Spray (Rhinocort, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.)|Detailed in arm descriptions
15854981|NCT04002349|Drug|Levocabastine Nasal Spray (Livostine, Shanghai Johnson & Johnson Pharmaceuticals, Ltd.)|Detailed in arm descriptions
15854982|NCT04002349|Drug|0.9% natural saline|Detailed in arm descriptions
15854983|NCT04002336|Behavioral|Traditional Voice therapy|Traditional method of voice therapy
15854984|NCT04002336|Behavioral|Voice Therapy App|Smartphone app, which allows participants to record home practice sessions in real time and upload sessions to the app server for the clinician to access and track.
15854985|NCT04002323|Drug|Dolutegravir 50mg Tab|The subjects starts their ART with this drugs, once a day
15854986|NCT04002323|Drug|Lamivudine 300 mg|The subjects starts their ART with this drugs, once a day
15854987|NCT04002310|Drug|BI 754132|One single injection
15854988|NCT04002297|Drug|zanubrutinib|Administered as two 80 mg capsules by mouth twice a day
15854989|NCT04002297|Drug|bendamustine|Administered intravenously at a dose of 90 mg/m2/day on Days 1 and 2 of Cycles 1 to 6
15854990|NCT04002297|Drug|rituximab|Administered intravenously at a dose of 375 mg/m2 on Day 1 of Cycles 1 to 6
15854991|NCT04002284|Drug|Anlotinib Hydrochloride|Anlotinib 12mg p.o. d1-14, 21days/cycle
15854992|NCT04002271|Drug|Propofol|Target controlled infusion (TCI) with modified Marsh effect site model (Fresenius Kabi) will be used for induction and maintenance of general anaesthesia. Level of anaesthesia will be titrated to produce a BIS value of between 40-60. For induction, remifentanil 1mcg/kg and rocuronium 0.6 mg/kg will be given intravenously prior to intubation. Sevoflurane will not be given. Air and oxygen will be given, and FiO2 will be kept at between 35-50%. Similarly, to the GAS group, remifentanil will be infused at a rate of between 0.1-0.2mcg/kg/min and titrated according to the haemodynamic parameters stated for the GAS group. Morphine sulphate will be given at a dose of 0.1mg/kg before skin incision. TCI propofol and remifentanil will be switched off at the end of the procedure. Reversal of muscle relaxation will be achieved as for the GAS group.
15854993|NCT04002271|Drug|Sevoflurane|Patients in the GAS group will be induced with intravenous bolus propofol 1.5-3mg/kg, remifentanil 1mcg/kg, and rocuronium 0.6mg/kg for induction of general anaesthesia and intubation of patient. General anesthesia monitoring will be used. Maintenance of general anesthesia to be provided using sevoflurane, together with air and oxygen. FiO2 will be maintained between 35-50%. Bispectral (BIS) monitoring will be applied and level of anaesthesia will be maintained at a BIS value of 40-60. Remifentanil infusion will be given at between 0.1-0.2mcg/kg/min, to be titrated to maintain mean arterial blood pressure within 20% of baseline (blood pressure in ward before surgery as baseline) and heart rate between 45 to 100 bpm. Morphine sulphate to be given at a dose of 0.1mg/kg before skin incision. Sevoflurane and remifentanil infusion will be switched off at the end. Reversal of muscle relaxation to be achieved using intravenous neostigmine 50mcg/kg and atropine 20mcg/kg after the operation.
15854994|NCT04002271|Procedure|Spinal anaesthesia|Patients in the SA group will receive intrathecal (L4-5, or L3-4 if failed at L4-5) administration of 2.2-2.4ml 0.5% heavy bupivicaine using a 25G Whitacare needle. No intrathecal opioid will be given during the procedure. Light sedation will be given during surgery with target-controlled infusion of propofol using the Marsh effect site model (0.3 -1 mcg/ml). Supplemental oxygen 2L/min will be given via the nasal cannula.
15854995|NCT04002258|Drug|Antipsychotic|any antipsychotic medicine that would have the effect on prolactin level, such as amisulpride, risperidone, olanzapine and so on.
15854996|NCT04002245|Procedure|antiseptic application|The application of the antiseptic on the healthy and visibly clean skin of the bend of the elbow will be carried out for all participant
15854997|NCT04002232|Device|CPP-ACP-NaF varnish|calcium phosphate containing fluoride releasing varnish to prevent caries
15854998|NCT04002219|Dietary Supplement|beverage containing mushroom-extracts|Subjects recruited from both arms will receive treatment and be followed up clinically for 8 weeks.
15854999|NCT04002206|Other|Muscle Energy Technique|In experimental group, post-isometric relaxation technique has given to the athletes. The position of athlete was prone and the involved group of muscle was quadriceps. Firstly end range of the quadriceps muscle group assess and guide the athlete to put 20% of their maximum voluntary contraction and physiotherapist resist the athlete and isometric contraction of quadriceps remain for 6-10 seconds
15855000|NCT04002206|Other|Static Stretch|Control group has treated with static stretching after the pre-assessment that includes three repetitions with duration of fifteen seconds with twenty second rest intervals on lower extremities
15855001|NCT04002193|Other|volume expansion|To assess fluid responsiveness
15855002|NCT04002180|Drug|Vedolizumab (Genetical Recombination)|Vedolizumab IV infusion
15855003|NCT04002167|Behavioral|Neurofeedback|The Neurofeedback group will receive the proposed intervention which integrates computerized working memory training with neuromonitoring and neurofeedback.
15855004|NCT04002167|Behavioral|Cognitive training|The Cognitive training group will receive computerized working memory training with performance feedback.
15855005|NCT04002154|Device|Papilocare vaginal gel|Papilocare is a gel vaginally administered by a single-dose cannula. Vaginal gel formulation is effective as a local treatment with controlled systemic absorption and rapid and efficient distribution
15855006|NCT04002141|Drug|Placebo oral tablet|1 tablet oral daily
15855007|NCT04002141|Drug|Letrozole|5mg oral daily
15855008|NCT04002128|Other|Tracheal aspirates and nasal smears were taken in all the patients. Laparotomies were performed in all patients.|Nitrous oxyde and sevoflurane anesthesia may alter mucus transport in the early postoperative period. In colonized patients it may result in more respiratory complications.
15855009|NCT04002115|Drug|Clofarabine|"Clofarabine to be administered pre-stem cell transplant infusion (Day 0) once a day for 5 days total."
15855010|NCT04002115|Drug|Fludarabine|Fludarabine will be administered once a day for 4 days as part of the transplant conditioning regimen.
15855011|NCT04002115|Drug|Busulfan|Busulfan will be administered once a day for 2 days as part of the transplant conditioning regimen.
15855012|NCT04002115|Procedure|Total Body Irradiation (TBI)|TBI will be administered at a dose of 200cGys on Day -1 prior to transplant
15855013|NCT04002115|Drug|Cyclophosphamide|Cyclophosphamide will be given once a day for 2 days after the transplant infusion.
15855014|NCT04002115|Drug|Granulocyte Colony-Stimulating Factor|G-CSF will be administered to subjects starting on Day +5 and will continue as clinically indicated
15855015|NCT04002115|Drug|Tacrolimus|Tacrolimus will be administered to subjects starting on Day +5 and will continue as clinically indicated
15855016|NCT04002115|Drug|Cellcept|Mycophenolate Mofetil will be administered to subjects starting on Day +5 and will continue as clinically indicated
15855017|NCT04002102|Other|OLP treatment|Receive two open-label placebo pills twice a day after randomization. Will receive for 21 days and then stop. It will include educational materials and positive expectancy.
15855018|NCT04002102|Other|Usual care|Remain in standard care after randomization and educational materials.
15855019|NCT04002102|Other|Expectancy Group|Educational materials and positive expectancy orientation via Zoom or telephone
15855020|NCT04002089|Drug|Exparel Injectable Product|bupivacaine liposome injectable suspension
15855021|NCT04002089|Drug|Bupivacaine|1.3%, 13.3 mg/mL
15855178|NCT04000906|Drug|Nab paclitaxel|Dose escalation (7.5 mg/m2, 15 mg/m2, 25 mg/m2, 37.5 mg/m2, 52.5 mg/m2 and 70 mg/m2)
15855022|NCT04002076|Behavioral|Robot-assisted hand combined with occupational therapy|Robot-assisted hand group contains 15 minutes of grasp and release motion, 15 minutes of visual feedback training and 30 minutes traditions occupational therapy. Traditional occupational therapy includes cognition training, sensory-motor function therapy, passive ROM exercise, functional hand training, activity of daily living skill training, instruction of using assistive devices,and so on.
15855023|NCT04002076|Behavioral|Traditional occupational therapy|Occupational therapy contains 60 minutes of traditional occupational therapy, which includes cognition training, sensory-motor function therapy, passive ROM exercise, functional hand training, activity of daily living skill training, instruction of using assistive devices,and so on.
15855024|NCT04002063|Behavioral|CBT MobileWork-V plus CBT|a smartphone app to assist with CBT homework skills practice plus CBT
15855025|NCT04002063|Behavioral|CBT alone|CBT therapy individual
15855026|NCT04002050|Behavioral|Cognitive Behavioural Therapy with Mindfulness Course|The Cognitive Behaviour Therapy with Mindfulness (CBTm) Course for Public Safety Personnel is a brief psychoeducational course consisting of 5 classes (90 minutes each) occurring on a weekly basis. The CBTm course addresses the fundamentals of CBT and provides participants with practical strategies for managing stress (such as relaxation strategies, cognitive restructuring, goal setting, behavioural activation, and exposure therapy).
15855027|NCT04002037|Drug|Triamcinolone Acetonide 40mg/mL|Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
15855028|NCT04002037|Drug|Triamcinolone Acetonide 10mg/mL|Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
15855029|NCT04002037|Drug|Dexamethasone 4 mg/ml|Corticosteroid injection will occur up to two times if trigger finger symptoms are not resolved.
15855030|NCT04002024|Other|Moisturizer with active ingredients|Moisturizer with active ingredients: 1 fingertip unit to cover one side of the face twice a day
15855031|NCT04002024|Other|Placebo|Placebo: 1 fingertip unit to cover one side of the face twice a day
15855032|NCT04002011|Drug|Warfarin|It will be started on postoperative day 1 or later when oral anticoagulation is secondary indicated. Daily dose will be adapted to obtain an international normalized ratio of [2.0-3.0]. Other anticoagulants will be not administrated.
15855033|NCT04002011|Drug|Dabigatran|It will be started when patients will be discharged from our center. Our pharmacist referent will validated the drug and its daily dose. Other anticoagulants will be not administrated.
15855034|NCT04002011|Drug|Rivaroxaban|It will be started when patients will be discharged from our center. Our pharmacist referent will validated the drug and its daily dose. Other anticoagulants will be not administrated.
15855035|NCT04002011|Drug|Apixaban|It will be started when patients will be discharged from our center. Our pharmacist referent will validated the drug and its daily dose. Other anticoagulants will be not administrated.
15855036|NCT04002011|Drug|Edoxaban|It will be started when patients will be discharged from our center. Our pharmacist referent will validated the drug and its daily dose. Other anticoagulants will be not administrated.
15855037|NCT04001998|Drug|BLD-2660|Randomized to active product
15855038|NCT04001985|Other|No clamp trial|Once the NG tube output is less than 500 mL over a 24 hour period with at least two other signs of return of bowel function the NG tube will be removed. Other signs of bowel function include flatus, bowel movement, change of NG tube output from bilious to more clear/frothy character, and hunger.
15855039|NCT04001985|Other|Clamp trial|Once the NG tube output is less than 500 mL over a 24 hour period with at least two other signs of return of bowel function, a 4 hour clamp trial will be performed. Other signs of bowel function include flatus, bowel movement, change of NG tube output from bilious to more clear/frothy character, and hunger. The NG tube will be taken off of suction and clamped. The NG tube is then reconnected to suction at the end of the four hour clamp trial and removed if less 125 mL drains or kept in place if greater than 125 mL drains. The same initial criteria are used again to determine if a clamp trial will be performed after 24 hours.
15855040|NCT04001972|Behavioral|Brief advice (AWARD model)|"Ask: smoking habit, quit intention and attempt, smoking reduction intention, previous quitting experience including NRT and SC use.
~Warn: smokers will be orally warned about the harms of smoking and receive a A5-sized leaflet, which includes some shocking pictures of smoking-related diseases, and SC services information.
~Advise: smokers will be advised to quit as soon as possible and use NRT or SC services.
~Refer: smokers will be encouraged to seek SC services for free NRT or other SC services. Those who agreed will be actively referred to their preferred SC services. The collected contact information with consent will be sent to the SC services providers for a quick appointment and follow-up.
~Do-it-again: Relapsed smokers (identified during follow-ups and IM conversation) will receive the Advise and Refer intervention."
15855041|NCT04001972|Drug|NRT-S|One-week free NRT (gum or patch) will be provided with dosage based on time to first cigarette smoking after waking up in the morning and previous NRT use (standard practice and according to specific NRT product instructions). Subjects who have first cigarette <30 minutes in the morning or have previously used NRT, will receive 4mg nicotine gum or 21mg nicotine patch. Those who have first cigarette >30 minutes after waking up and have not previously used NRT will receive 2mg nicotine gum or 14mg nicotine patch. NRT use and potential side effects will be briefly explained orally based on standardized script according to the product instructions. An NRT use card containing reminders of NRT use and potential side effects will be given.
15855042|NCT04001972|Behavioral|IM Apps and Chatbot|Twelve-week personalized behavioral support will be delivered using interactive communication technologies using (1) regular tailored messages on abstinence, and (2) synchronous IM Apps conversation with trained SC advisors, and (3) a Chatbot: A Chatbot will be built using open source NLP and machine intelligence platforms. The unstructured text data from our previous study (ClinicalTrials.gov ID: NCT03182790) will be used to train the proposed Chatbot. We will draft responses for each identified question. The final version will be incorporated with Application Programming Interface (API) integration into user-friendly apps (iOS/Android/web app) with a backend server support and continuous data collection for potential bigdata analysis.
15855043|NCT04001972|Behavioral|Regular SMS message|Regular SMS messages focus on general health and remind the importance of participating in the follow-up surveys and biochemical validation for quitting
15855044|NCT04001959|Procedure|Silver Diamine Fluoride with Potassium Iodide|Dry the tooth for 30 seconds with air jet and apply one drop of Diamino 30% Silver Fluoride with a disposable applicator brush for 3 minutes and one drop of potassium iodide solution immediately on the treated surface, then wash.
15855046|NCT04001933|Other|CPOP Intervention|The intervention consists of two 15-minute interactive modules (maternal and infant OH), integrated into 2 group prenatal care sessions. Led by trained prenatal care providers (facilitators), the maternal module includes discussion of common OH problems during pregnancy, importance of OH, importance and safety of OH care during pregnancy, hands-on skills-building activities of learning and practicing proper tooth brushing and self-assessment of gum health, and presentation of illustrated flossing and OH promotion guides. The infant module includes discussion of infant oral hygiene, avoiding saliva sharing, proper nutrition, and importance of a dental visit by the first birthday. Activities in both modules utilize separate tool kits including tooth brushes, fluoride toothpaste, and other supplies.
15855047|NCT04001920|Other|Training program|12-week, 18-session training program. To offer a complete training program aimed at improving function it was divided : the first 6 weeks were dedicated to strength-training (2 sets of 6 repetitions at 80% of 1-RM), whereas the following weeks focused on endurance-training (1 set of 25 repetitions at 40% of 1-RM).
15855048|NCT04001907|Behavioral|Resistance exercise|effect of exercise and an anabolic agent on body composition, muscle strength, phenylalanine and protein oxidation.
15855049|NCT04001907|Dietary Supplement|β-hydroxy-β-methylbutyrate|
15855050|NCT04001907|Dietary Supplement|placebo|
15855051|NCT04001894|Drug|Ticagrelor 90mg|Ticagrelor (90.0 mg twice daily) for 2 weeks, followed by a 2-week washout period then 2 weeks crossover phase of clopidogrel (75mg once daily).
15855052|NCT04001894|Drug|Clopidogrel 75mg|Clopidogrel (75mg once daily) for 2 weeks, followed by a 2-week washout period then 2 weeks crossover phase of ticagrelor (90.0 mg twice daily).
15855053|NCT04001881|Other|Transthoracic echocardiography|A standard TTE protocol is used in all patients and included the following views: subcostal 4-chamber (SUBC), apical 4-chamber (4CH), apical 2-chamber (2CH), apical 3-chamber (3CH), parasternal long (LAX) and short axis (SAX).
15855054|NCT04001881|Drug|Spinal anesthesia|Spinal anesthesia is introduced with a single intrathecal injection of 15 mg plain ropivacaine (0.75% solution) using a 22 or 25-gauge needle (pencil-point) with the patient in the lateral position.
15855055|NCT04001868|Procedure|Suboccipital inhibition|With the patient in the supine position and the therapist sitting at the head of the bed with the elbows resting on its surface. The therapist palpates the cervical spinous processes and slides the fingers upwards until contacting the posterior projection of the posterior arch of the atlas. Then, flexing the metacarpophalangeal at 90 degrees slowly raises the skull. The therapist's hands should remain together and the base of the skull should rest on his palms pressing with the index, middle and ring fingers of each hand in a sustained manner, but without causing pain. This pressure must be maintained during 4 minutes.
15855056|NCT04001868|Procedure|Placebo technique|A superficial contact in the same area as the intervention, to rule out the exteroceptive effect associated with the therapist's contact.
15855057|NCT04001855|Other|Dilute vinegar (acetic acid)|Dilute vinegar baths or gauze soaks
15855058|NCT04001855|Other|Dilute bleach|Dilute bleach baths or gauze soaks
15855059|NCT04001842|Other|Surgical reconstruction of the mandible using an axially vascularized bone construct|Surgically reconstructing defects of the mandible using reconstruction plate and Titanium mesh filled with an artificial bone substitute to form a bone construct. This construct will be vascularized at the same operation using a vein graft from the forearm. The vein graft will be microsurgically connected to an artery and vein within the facial/neck region to provide a vascular supply to the construct (arterio venous loop)
15855064|NCT04001816|Other|Orthodontic Brackets|Self ligating and Conventional brackets
15855065|NCT04001803|Drug|CAB LA+RPV LA|Subjects will receive one tablet of CAB 30 milligram(mg) + RPV 25 mg once daily from Day 1 for 1 month. During month 1, subjects will receive 600 mg of CAB LA injection+ 900 mg of RPV LA injection. Following Month 1, subjects will receive 400mg of CAB LA + 600mg of RPV LA at each subsequent injection.
15855066|NCT04001790|Behavioral|Project Search plus ASD Supports|Nine month job training program embedded on Fort Eustis military base.
15855067|NCT04001777|Drug|APG-1252|Multiple dose cohorts, 30 minute IV infusion, weekly for 3 weeks of a cycle with 21days.
15855068|NCT04001777|Drug|Osimertinib Mesylate Tablets|Osimertinib Mesylate Tablets 40mg/80 mg, one time a day until disease progression
15855069|NCT04001764|Procedure|The radial artery cannulation over 2 cm of the wrist|The radial artery catheterization performed as short axis out-of-plane with USG over 2 cm of the wrist.
15855070|NCT04001764|Procedure|The radial artery cannulation in the distal 3/4 area of the forearm|The radial artery catheterization will be performed in the distal 3/4 area of the forearm with ultrasound-guided short axis out of plane intervention.
15855071|NCT04001764|Procedure|The radial artery cannulation in the distal 1/2 area of the forearm|The radial artery catheterization will be performed in the distal 1/2 area of the forearm with ultrasound-guided short axis out of plane intervention.
15855072|NCT04001751|Behavioral|educational yoga program|"Daily 15-min yoga sessions at home with the Le guide du yoga and the audio-guide, during 12 weeks.
~One 90-min yoga-therapeutic education session/week (during 6 weeks) given by a physical therapist trained to postural yoga."
15855073|NCT04001738|Other|Direct Transfer to Angio Suite|Patient will be direct transferred to angiography suite where EVT team will be waiting for it.
15855074|NCT04001725|Drug|Dexamethasone|A minimum daily dosage of 8 mg through the oral, intramuscular or intravenous administration route, once or twice a day.
15855075|NCT04001725|Drug|Metformin|A minimum daily dosage of Dexamethasone 8 mg through the oral, intramuscular or intravenous administration route, once or twice a day and 2550 mg daily (maximum dose), oral administration (OS) of Metformin; starting dose will be 850 mg/day, to be progressively increased to 1700 mg/day on day 4 and 2550 mg/day on day 7, if well tolerated.
15855076|NCT04001712|Drug|Caffeine Citrate|caffeine citrate is given early to preterm neonates in need of respiratory support
15855131|NCT04001322|Other|IRISS advert for opt-in|A module to advertise and demonstrate how individuals can opt-in to IRISS to receive the messages will be included in the community engagement sensitization meetings.
15855179|NCT04000906|Drug|Cisplatin|10.5 mg/m2
15858415|NCT03974932|Drug|+/- Bupivacaine HCl|Local anesthetic.
15855077|NCT04001699|Other|Preoperative geriatric assessment|In addition to the usual care, patients randomized to the intervention group receive preoperative assessment conducted by an interprofessional team including geriatrician, registered nurse, physiotherapist and pharmacist. Based on the assessment, a preoperative optimization plan is constructed focusing on the treatment of the patient's chronic conditions, nutritional status, medication and physical activity.
15855078|NCT04001686|Other|incidence aplastic anemia|Ambispective chart review
15855079|NCT04001673|Behavioral|Pharmacist's intervention|Information about bDMARDs management.
15855080|NCT04001660|Procedure|Subbrow Blepharoplasty Combined with Double Eyelid Surgery|An upper incision is made along the inferior margin of the eyebrow. A lower incision is determined according to necessary amount of skin excision. Then the skin and subcutaneous tissue were excised. The orbicularis oculi muscle (OOM) was separated and an OOM flap dissection was extended to the width of 15mm. A dissected OOM flap was lifted up and three transverse 3-0 nylon sutures were placed to fix it to the periosteum and then covered by the upper myocutaneous flap of the supraorbital rim. Through eyelid-crease approach the supratarsal upper eyelid skin and orbital fat was excised, adjusted and reshaped double-fold eyelids at the same time.
15855081|NCT04001647|Drug|Acetylcholine|Endothelium-dependent vasodilation will be determined via graded intra-arterial infusions of acetylcholine (ACh). Doses of 1, 4, 8, and 16 μg/100ml forearm volume/min will be infused in the brachial artery for 3 minutes each.
15855082|NCT04001647|Drug|Sodium Nitroprusside|Endothelium-independent vasodilation will be determined via graded intra-arterial infusions of sodium nitroprusside (SNP). Doses of 0.25, 0.5, 1, and 2 μg/100ml forearm volume/min will be infused in the brachial artery for 3 minutes each.
15855083|NCT04001647|Drug|Ascorbic Acid|The influence of oxidative stress on arterial stiffness and vasodilation will be assessed by using intravenous ascorbic acid (AA). A single supra-physiological dose of 0.06 g/kg fat-free mass (FFM) will be infused over 20 min followed by a drip infusion of 0.02 g/kg FFM administered over 60 min.
15855084|NCT04001621|Drug|Pyrotinib combined with capecitabine|pyrotinib 400 mg once daily; Capecitabine 1000 mg/m2 per day on day 1 through 14, every 21 days.
15855085|NCT04001608|Drug|Seraprevir|Subjects will receive oral tablets of Seraprevir 100 mg, twice a day from Day 1 up to Week 12
15855086|NCT04001608|Drug|Sofosbuvir|Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12
15855087|NCT04001595|Other|Patient Registry|Participants who have volunteered to participate will complete various questionnaires relating to their condition.
15855088|NCT04001582|Other|Patient Registry|Participants who have volunteered to participate will complete various questionnaires relating to their condition.
15855089|NCT04001569|Drug|AZD8186 in combination with paclitaxel|"Phase 1b is planned for a 4-stage dose level and the traditional 3+3 design is applied. The RP2D will be determined based on the MTD and toxicity profiles.
~In phase 2 part, RP2D from the phase 1b part will be applied.
~AZD8186 ( )mg po bid, 5 days on, 2 days off
~Paclitaxel ( )mg/m² on D1,8,15 every 4 weeks"
15855090|NCT04001556|Diagnostic Test|Minor Salivary gland Biopsy|Minor salivary gland biopsy with injection of lidocain
15855091|NCT04001556|Diagnostic Test|ARFI|Acoustic Radiation Force Impulse on Major Salivary Glands
15855092|NCT04001556|Diagnostic Test|MSG US|Ultrasonography of Major Salivary Glands
15855093|NCT04001543|Dietary Supplement|Immunomodulating oral supplementation|Per os administration, 3 times / day, 5 days before each cycle of chemotherapy.
15855094|NCT04001543|Dietary Supplement|Sip feed control|Per os administration, 3 times / day, 5 days before each cycle of chemotherapy.
15855095|NCT04001530|Drug|Half Normal Saline 0.45% Infusion Solution Bag|Randomization to half normal saline
15855096|NCT04001530|Drug|Normal Saline 0.9% Infusion Solution Bag|Randomization to normal saline
15855097|NCT04001517|Drug|Neflamapimod|Double-Blind, Placebo-Controlled
15855100|NCT04001478|Diagnostic Test|Breath test|Patients will provide a breath test prior to gastroscopy or resection of Barrett's HGD lesion or oesophageal cancer.
15855101|NCT04001465|Procedure|Volumetric methacholine challenge unmodified|Bronchoprovocation challenge performed per volumetric method
15855102|NCT04001465|Procedure|Modified volumetric methacholine challenge|Bronchoprovocation challenge performed per volumetric method modified to include use of ultrasonic spirometer fitted with vibrating mesh nebulizer
15855103|NCT04001439|Drug|Experimental drug|All patients will recive 30 microbiota capsules intake preceded by bowel lavage by 4 liters macrogol solution. the capsules are developed by the services of JC Lagier.
15855104|NCT04001426|Device|The FemPulse System|Non-invasive monitoring during activation of the FemPulse System
15855105|NCT04001413|Drug|MEDI0457|MEDI0457 is an investigational drug that will be administered with the Cellectra Device in this study
15855106|NCT04001413|Drug|Durvalumab|Durvalumab is an investigational drug in this study.
15855107|NCT04001400|Drug|Rabeprazole 20mg bid|Rabeprazole 20mg tablet b.i.d.
15855108|NCT04001400|Drug|Rabeprazole 20mg qd|Rabeprazole 20mg tablet q.d.
15855109|NCT04001387|Procedure|Real-time ultrasound guided spinal anesthesia|The neuraxial US scan will be performed with the patient in the lateral position with the hip and knees flexed using full aseptic technique. The spinal needle will be inserted in real-time under direct ultrasound guidance using dynamic needle tip positioning to administer the spinal anesthetic.
15855110|NCT04001374|Drug|Ticagrelor|90mg tablet bid for 12 months
15855111|NCT04001374|Drug|ASA|enteric coated aspirin 81mg-100mg daily p.o. for 12 months
15855112|NCT04001361|Procedure|Laser Cell Therapy|Bone marrow aspirate combined with laser to alter the cartilage matrix to facilitate repair
15855113|NCT04001348|Device|Acti-Lance Lite|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure."
15855132|NCT04001322|Other|One-time SMS broadcast on immunization|General broadcast of SMS messages on the importance of immunization to all active mobile phone subscribers in the intervention LGAs
15855114|NCT04001348|Device|Acti-Lance Universal|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure."
15855115|NCT04001348|Device|Acti-Lance Special|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure."
15855116|NCT04001348|Device|Medlance Plus Super Lite|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure."
15855117|NCT04001348|Device|Medlance Plus Lite|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure."
15855118|NCT04001348|Device|Medlance Plus Universal|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure."
15855119|NCT04001348|Device|Medlance Plus Extra|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure."
15855120|NCT04001348|Device|Medlance Plus Special|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure."
15855121|NCT04001348|Device|Prolance Micro Flow|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure."
15855122|NCT04001348|Device|Prolance Low Flow|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure."
15855123|NCT04001348|Device|Prolance Normal Flow|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure."
15855124|NCT04001348|Device|Prolance High Flow|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure."
15855125|NCT04001348|Device|Prolance Max Flow|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure."
15855126|NCT04001348|Device|Prolance Pediatric|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure."
15855127|NCT04001348|Device|MediSafe Solo 29 Gauge|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure."
15855128|NCT04001348|Device|MediSafe Solo 23 Gauge|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler. Perceived pain was assessed on the visual analog scale (VAS, numeric scale). VAS scale was assessed 5 minutes after the lancing procedure."
15855129|NCT04001335|Diagnostic Test|Dental Broach|Dental broach, RDT and PCR
15855130|NCT04001322|Other|Community engagement|The government will conduct a cascade of sensitization meetings with traditional leaders at all levels to promote newborn line listing (birth registration), reconciliation of child's vaccination status and defaulter tracking (home-based follow up of children who have missed their vaccination doses) by health providers and community leaders
15861016|NCT03954275|Other|no intervention|no intervention
15855133|NCT04001322|Other|Scheduled weekly SMS reminder of health facility RI schedule to community leaders|"Traditional and religious leaders who have a phone or access to a phone and have been registered on IRISS will receive SMS messages on the immunization session schedule of the health facilities in their communities, so they can disseminated the information through their town announcers to inform parents and caregivers. For example, Ribah clinic is holding a vaccination session tomorrow from 8am to 2pm. Please take your child there to vaccinate them and encourage your neighbors to vaccinate their children."
15855134|NCT04001322|Other|Scheduled bi weekly RI messages to community leaders|"Traditional and religious leaders who own or have access to a phone and have been registered on IRISS will receive SMS messages on immunization, to share same with community members. The message categories are: 1) Educational messages that provide facts and increase knowledge, e.g. Have you heard of Penta vaccine? It protects against 5 diseases: they are diphtheria, whooping cough, tetanus, HiB and Hepatitis B. 2) Informative messages that dispel myths about immunization, e.g. Getting more than one vaccine at the same time does not harm a child. It is very important to completely receive all vaccine doses for full protection. 3) Normative messages to promote positive norms, e.g. Our religious leaders have immunized their children, what are we waiting for? 4) Motivational messages to inspire action, e.g. Each visit to the health center for vaccination will reap many health benefits. Say YES to good health, be on time and complete your child's vaccination."
15855135|NCT04001322|Other|Responsive individualized child vaccination schedule reminder to caregivers who opt-in|"Parents and caregivers who voluntarily registered their child's information into IRISS will receive a reminder, a day before, about their child's due vaccines and the schedule of vaccination sessions in the health facilities within their locality (wards), e.g. Greetings! Amina is due for Penta 1 tomorrow, kindly visit Ribah clinic. They vaccinate on Mondays and Thursdays."
15855136|NCT04001322|Other|Responsive one-time SMS message on hand washing to those that erroneously register on IRISS|"If individuals from control LGAs encounter IRISS adverts inadvertently and erroneously register into IRISS expecting a message, to avoid a loss in trust if no message is sent, they will receive a one-time general message about the importance of hand-washing, e.g. Wash your hand with soap and water every time you finish from to the toilet, to maintain clean hands and avoid germs that make you sick."
15855137|NCT04001309|Other|Implementation of prospective audit and feedback stewardship interventions to reduce unnecessary use of antimicrobials and improve quality of prescriptions|Prospective audit and feedback of antimicrobial therapy at hospital wards, by interventions performed by infectious diseases specialists alone or using a team-based approach.
15855138|NCT04001296|Behavioral|21 day Brush Day and Night school programme|Children participating in the 21 day Brush Day and Night school programme are provided with toothpaste and a toothbrush each and enjoy brushing instruction, supervised brushing, and the singing of songs to facilitate learn the importance of brushing day and night, and stickers and calendars to track progress. A celebration is held at the end of the programme with certificates and rewards. The programme is supported by colourful and attractive materials with bespoke cartoon characters. Parents are provided with educational leaflets.
15855139|NCT04001283|Drug|Sodium Nitrite|Intravenous drug infusion
15855140|NCT04001283|Drug|0.9% Sodium-chloride|Matched placebo
15855141|NCT04001231|Drug|Exenatide Once-Weekly Suspension|A single dose will be administered as 2.0-mg dose of exenatide onceweekly suspension via subcutaneous (SC) injection followed by blood samples be drawn for up to 168 hours after the first dose on Day 1 to assess single-dose PK for exenatide once-weekly suspension. Subsequently Patients will receive the second dose of the investigational product (IP) at Visit 6 (Day 8). Thereafter, patients will receive weekly (±1 day) doses of IP up to Visit 18 (Week 14).
15855142|NCT04001218|Drug|Injection of hypertonic saline|Painful condition: Participants will be injected in a neck muscle with 0.5ml of hypertonic saline (5.8%)
15855143|NCT04001218|Drug|Injection of Isotonic saline|Control condition: Participants will be injected in a neck muscle with 0.5ml isotonic saline (0.9%)
15855144|NCT04001205|Drug|Anticoagulation Therapy|Long term oral anticoagulation with VKA (vitamin K antagonist) or NOAC (non-vitamin K oral anticoagulant)
15855145|NCT04001192|Behavioral|aerobic exercise program|The intervention is exercise at home, 5-6 days per week during 12 weeks, guided by a schedule that the physiotherapist will design after initial treadmill testing. Exercise intensity is 80-90 % of the heart rate threshold that was identified by the treadmill test. During the 12 weeks program, intensity will be increased according to feedback from the participant.
15855146|NCT04001179|Other|Pulmonary embolism diagnosis by nuclear medicine imaging|nuclear medicine imaging
15855147|NCT04001166|Other|Non-interventional study|This is a non-interventional study. Patients will be treated with any treatment deemed appropriate by the patient's physician.
15855148|NCT04001153|Other|Dental impressions|"Children will be included in this study if they already are treatment planned to receive a Hall Technique preformed metal crown (HTPMC) to manage carious lesions in primary molars. They will have a dental impression taken before and after the HTPMC placement to find out what happens with their bite after the treatment.
~The dental impressions will be cast up into stone study models so that we can track the changes that happens in children's bites after placing the HTPMC (as it increases the height of children's bite when placed) and let them know what to expect after this procedure and as part of this study, additional follow-ups will be required 2, 4, 6 and 8 weeks after the HTPMC placement to allow us to track the changes in the bite at regular intervals to see when the child's bite returns to its pre-treatment state."
15855149|NCT04001140|Behavioral|Enhancement of emotion regulation skills|Regarding the intervention, 7 sessions will be carried out. The main purpose is to help adolescents to enhance their emotion regulation, with the ultimate goal to decrease their risk of developing addictions and other psychopathology.
15855150|NCT04001127|Other|High Intensity Functional Training|"The exercise intervention for this study will be HIFT, defined as a style of training that incorporates functional, multimodal movements, performed at relatively high intensity, and designed to improve parameters of general physical fitness and performance. The program design and template will be based on the principles of the HIFT program called CrossFit®. CrossFit is described as a strength and conditioning program that focuses on constantly varying functional movements, performed at a relatively high intensity. CrossFit training includes a variety of elements from gymnastics (e.g., floor, bar and ring exercises), weightlifting exercises (e.g., squats, cleans, snatches and presses with a barbell, dumbbell or kettlebell), and cardiovascular activities (e.g., running or rowing)."
15863068|NCT03937635|Drug|Lenalidomide|Given PO
15855151|NCT04001114|Combination Product|Sampling Research Cigarettes|Participants sample two research cigarettes, which differ in typical tobacco smoke constituents such as tar, nicotine, carbon monoxide, etc. In the Cigarette Discrimination Session, participants sample both types of cigarettes repeatedly, guess their identity (A or B) with regard to reference cigarettes, and rate their subjective effects. In the Ad Libitum Smoking Session, participants can smoke one of these cigarette types as much or as little as they like for eight hours.
15855152|NCT04001101|Combination Product|RT and Anti-PD-1|limited metastatic site radiation
15855153|NCT04001101|Drug|Anti-PD-1|anti-PD-1 therapy alone
15855154|NCT04001088|Dietary Supplement|Probiotic|Dosing regimen of one capsule daily for a maximum of 48 weeks.
15855155|NCT04001088|Other|Placebo|Dosing regimen of one capsule daily for a maximum of 48 weeks.
15855157|NCT04001062|Procedure|Surgical Fixation|For both scissoring and non-scissoring injuries surgical fixation by either pinning, dorsal plate, or lag screws will be considered. This will be determined by surgeon expertise at the time of surgical fixation. Postoperative, a volar short arm splint and immediate AROM at full range with buddy taping to adjacent digit will be indicated. Transition to removable short arm splint at week 2 after suture removal. No strengthening until clinical union.
15855158|NCT04001062|Other|Non-Operative Management|"For non-scissoring injuries: Placement of short-arm cast; immediate AROM with buddy taping to adjacent digit. Focus on achieving pulp-to palm distance of <2cm at first visit. Transition to removable short arm splint at week 2 (discontinue at 6 weeks or when non-tender). Strengthening after clinical union.
~For scissoring injuries: Closed reduction in clinic/ER and placement of short-arm cast; immediate full range AROM with buddy taping to adjacent digit. Focus on achieving pulp-to palm distance of <2cm at first visit. Transition to removable short arm splint at week 2 (discontinue at 6 weeks or when non-tender). Strengthening after clinical union"
15855159|NCT04001036|Drug|1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitine|One bag for nocturnal (long-dwell) exchange.
15855160|NCT04001036|Drug|0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitine|One to three, daily (short-dwell) exchanges
15855161|NCT04001023|Device|Imaging with 18F-EF5 PET/CT|Both 18F-FDG PET/CT and 18F-EF5 PET/CT imaging are performed in 1) preoperative work-up to clarify the disease distribution, 2) before IDS to evaluate treatment response to NACT (IDS arm); targeted samples from hypoxic and non-hypoxic tumors are collected during surgery
15855162|NCT04001010|Drug|PPP011|1 capsule inhaled 3 times a day with a vaporizer device
15855163|NCT04001010|Drug|Placebo|1 capsule inhaled 3 times a day with a vaporizer device
15855164|NCT04000984|Behavioral|Mindfulness Based Training (MBT) Program|Participants in the MBT program will meet weekly for 8 weeks. Each session will last one-and-a-half hours. Mindfulness, defined as caring moment-to-moment awareness, will be cultivated through the teaching and formal practice of sitting and walking meditation, body scan, and mindful movement (e.g. yoga). Participants will also be taught how to practice mindfulness informally when eating, engaging in pleasurable activities and through interactions with others. Participants will be encouraged to practice approximately 30 minutes a day, and will be provided handouts as well as guided audio recordings of formal practices taught in session to aid their practice at home.
15855165|NCT04000984|Behavioral|Cognitive Rehabilitation Training|Participants in the CRT program will meet weekly for 8 weeks. Each session will last one-and-a-half hours. The 8 week-program will consist of the following components: (i) identifying and working on at least one personal rehabilitation goal related to everyday life that is associated with cognitive difficulties; (ii) reviewing and building on the use of practical memory strategies, and or introducing and teaching the use of a new strategy or memory aid; (iii) introducing techniques for learning new information and associations, identifying the preferred strategy, and encouraging the application of this strategy in daily life; (iv) providing practice in maintaining attention and concentration; and (v) exploring current ways of coping with stress and anxiety as well as providing relaxation techniques to help aid with coping (Clare, 2007). Participants will be provided with instructional hand-outs as well as logs to record, monitor and evaluate their progress.
15855166|NCT04000971|Other|Integrated Stroke Practice Unit|Care teams will follow patients in their home or rehabilitation/skilled nursing facility monthly for 12 visits to assess recovery, manage risk factors, and increase understanding and build positive behavior change for patients and caregivers. Primary and secondary outcomes will be assessed at 3,6,and 12 months and by phone at 24 months.
15855167|NCT04000971|Other|Comprehensive or Primary Stroke Center|Primary and secondary outcomes will be assessed at 3,6,and 12 months and by phone at 24 months.
15855168|NCT04000958|Drug|PIRF measured by InCheck DIAL|Peak inspiratory flow rates(PIFR) will be measured using the InCheck DIAL(Clement Clarke International Ltd, Harlow, UK and Alliance Tech Medical). The InCheck DIAL is accurate to +/- 10% or 10 L/min, whichever is greater, and can measure flows in the range of 15 to 120 L/min. Dry powder inhaler(DPI) is to be prescribed if PIFRr is over 60L/min, otherwise pressure metered dose inhaler(pMDI) with spacer is given. All the patients will be given inhaled corticosteroid（ICS）/long-acting β agonist（LABA）. For symptomatic patients, long-acting anticholinergic agents(LAMA) will also be used.
15855169|NCT04000958|Drug|Regular treament|The choice of inhalers depends on physician's evaluation. The medication is the same as experimental group.
15855170|NCT04000945|Device|BTL-899|Treatment with BTL-899 device, 3 therapies
15855171|NCT04000945|Device|Sham|Sham treatment with BTL-899 device, 3 visits
15855172|NCT04000932|Drug|Local platelet rich plasma (PRP) injection-T-Lab PRP kit|Platelet rich plasma (PRP) will be obtained by centrifugation of autologous anticoagulated whole blood. 1 ml PRP extract will be injected into the carpel tunnel (of the side with a diagnosis of carpel tunnel syndrome) via the distal wrist line using 23 gauge needle.
15855173|NCT04000932|Drug|Local steroid injection-Diprospan ®, Schering Plough|The local steroid injection ((1 ml Diprospan ®, Schering Plough containing 6.43 mg of betamethasone dipropionate and 2.63 mg of betamethasone sodium phosphate) will be performed once into the carpal tunnel.1 ml Diprospan ®, Schering Plough extract will be injected by using 23 gauge needle from the distal wrist line through the carpal tunnel only once.
15855174|NCT04000919|Drug|5HTP|5HTP/carbidopa (50-200 mg 5-HTP/50 mg carbidopa)
15855175|NCT04000919|Drug|L-DOPA|L-DOPA/carbidopa (50-200 mg L-DOPA/50 mg carbidopa)
15855176|NCT04000919|Drug|Placebo oral tablet|Placebo
15855177|NCT04000919|Drug|Carbidopa|Carbidopa (50mg)
15855180|NCT04000893|Other|Resistance exercise session|Acute isometric exercise session performed with handgrip Jamar about 20 minutes monitored.
15855185|NCT04000867|Device|Transcutaneous Magnetic Stimulation (TCMS)|The study will evaluate whether an experimental medical device that emits a series of brief, intense magnetic pulse called TCMS will relieve foot pain from Diabetic Neuropathy (DN) when compared to the same device giving a sham treatment without magnetic pulses. Participants will be blindly randomized into either the TCMS treatment group or the sham treatment group according to the number 1-20 that they draw. This is necessary to further investigate this TCMS treatment and to determine how to obtain statistically significant data as to whether this therapy reduces the foot pain caused by diabetic neuropathy.
15855186|NCT04000854|Drug|Calcium hydroxide (Calacept)|Long-term follow up of pulp regenerative treatment using two different root canal dressings: calcium hydroxide and chlorhexidin digluconate in immature necrotic traumatized incisiors
15855187|NCT04000841|Behavioral|Mindful You mobile app|"The CRSR intervention consists of a native mobile application for Android and iOS devices. The mobile app includes:
~Guided meditations of varying length designed to connect the user to the present moment and a place of calm through culturally aligned exercises grounded in spirituality, orality, self-empowerment, and resilience.
~User-customized notifications prompting users to reflect and engage with the app, such as providing African American proverbs and quotes and asking simple questions like What are you grateful for today?
~Scheduled messages on the importance mindfulness as a way increase control over physical and psychological health
~User-customized reminders to do specific meditations and display personally selected images or messages."
15855188|NCT04000828|Device|Placement of Sensimed Triggerfish|Sensimed Triggerfish is placed on the corneal surface
15855189|NCT04000815|Diagnostic Test|C Type Natriüretic Peptide|C Type Natriuretic Peptide will be measured with elisa method
15855190|NCT04000802|Behavioral|response to questionnary|No intervention. Observational study
15855191|NCT04000789|Drug|Sodium Hyaluronate, Vitamin A, Vitamin E|Eye drops consisting of combination of Sodium Hyaluronate, Vitamin A, Vitamin E will be . given to patients in control groups
15855192|NCT04000776|Diagnostic Test|FDG Positron emission tomography (PET) scan|"Patients will undergo 18F-FDG and whole-body PET/CT (vertex to thighs, or to feet if known lower-limb metastases).
~The patient will be measured and weighed before the exam in order to calculate a personalized dose. An intravenous catheter will be put in place in peripheral vein to allow injection of the tracer."
15855193|NCT04000776|Diagnostic Test|PSMA Positron emission tomography (PET) scan|Patients will sequentially undergo 68Ga-PSMA and whole-body PET/CT (vertex to thighs, or to feet if known lower-limb metastases).
15855194|NCT04000776|Diagnostic Test|OCTREOTATE Positron emission tomography (PET) scan|"In the case a patient would present at least one PSMA-negative/FDG-positive lesion, he will be referred to undertake a whole-body 68Ga-OCTREOTATE PET/CT within 10 days of the first PET/CT. The delay between this third PET scan and the last one should be minimal (not least than 18 hours, not more than 10 days).
~Images and data will be reviewed centrally within 4 days by the Imaging Corelab, which will produce a final report confirming patient's eligibility to Radioligand therapy (RLT)."
15855195|NCT04000776|Other|Optional Bone or soft-tissue biopsies|Patients presenting FDG-positive/PSMA-negative or Octreotate-positive lesions on imaging will be asked to undergo a biopsy of these lesions (optional) for research purposes. Bone or soft-tissue biopsies will be collected by an interventional radiologist according to site's standard-of-care procedure and sent to the local pathology department for preparation (formalin-fixed and paraffin-embedded); the blocks being sent to the Pathology Corelab.
15855196|NCT04000763|Device|superficial peroneal nerve stimulation|A commercially available FDA-approved transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes will be used to stimulate the foot. The electrodes will be attached to the dorsal surface of the foot and a sock will be placed over the foot to prevent detachment of the electrodes. Based on our animal studies, foot stimulation parameters of 2 Hz frequency and 0.2 ms pulse width will be used at the maximal intensity comfortable for each patient. It is expected that superficial peroneal nerve stimulation in patients can increase bladder sensation so that micturition can be initiated at a small bladder volume, or it can initiate bladder contraction at a small bladder volume and enhance the contraction or prolong the duration of contraction. Any of these excitatory effects, if occurs in human patients, will certainly improve the condition of non-obstructive urinary retention.
15855197|NCT04000750|Other|Time Restricted Eating|Diet will be tracked and reported every day to a qualified dietitian.
15855198|NCT04000750|Other|Normal Feeding|Diet will be tracked and reported every day to a qualified dietitian.
15855199|NCT04000750|Other|Resistance Training|8 weeks of supervised and programmed whole body resistance training, performed 4x per week
15855200|NCT04000750|Dietary Supplement|Whey Protein|Consumed on all exercise days.
15855201|NCT04000737|Drug|YIV-906+Sorafenib|Patients will be treated orally for 28-day courses with YIV-906 (600 mg (3 capsules) BID) + sorafenib (400 mg BID) according to the following schedule: sorafenib BID daily treatment for 28 days, and YIV-906 BID 4 days on and 3 days off weekly in each course.
15855202|NCT04000737|Drug|Placebo+Sorafenib|Patients will be given sorafenib (400 mg BID) daily for 28-day course with placebo (3 capsules, BID) 4 days on and 3 days off weekly in each course.
15855203|NCT04000724|Behavioral|Text Messaging (Text+Step)|Participants receive three culturally competent, theory-based pre-written messages per day sent on a predetermined schedule. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks.
15855204|NCT04000724|Behavioral|WebApp (App+Step)|Participants receive access to a culturally competent password-protected web-based application with transgender-specific resources, support, and health information. Participants who still exhibit sexual risk and do not uptake and/or adhere to PrEP at the 3-month assessment may also receive eCoaching for up to 12 weeks.
15855205|NCT04000724|Behavioral|Information/No Step|Participants in the Information/No Step intervention will receive access to a static website with information about trans health, HIV/STI information and local resources tailored for transgender persons.
15855206|NCT04000711|Other|Outpatient oral treatment.|Participants allocated in oral outpatient group were discharged home with oral antibiotic to continue management. Participants were given Cefixime oral suspension (100 mg/5 mL). Antibiotic was given to the caretakers with written instructions about dosage and time of administration. Dosage indicated was 8 mg/kg/day to be given orally as a single dose (max dose 400 mg/day). Oral antibiotic treatment was given until documented ANC > 500, failure to treatment (restart of fever) or when 14 days of antibiotic were completed (whichever occurred first).
15855207|NCT04000711|Other|Inpatient intravenous treatment.|Participants allocated in the intravenous inpatient group continued receiving Cefepime 150 mg/kg/day every 8 hours (max dose 2 grams per dose or 6 grams per day) according to local standard of care guidelines. Intravenous antibiotic treatment was given until documented ANC > 500, failure to treatment (restart of fever) or when 14 days of antibiotic were completed (whichever occurred first).
15855208|NCT04000698|Drug|Preparative regimen|"Preparative chemotherapy before allogeneic HSCT
~Fludarabin
~Cytarabine
~Venetoclax
~Daratumomab
~Vecanoid Condition
~treosulfan
~fludarabine
~thiophosphomide
~Venetoclax
~Plerixafor GVHD prophylaxis
~abatacept
~tocilizumab
~rituximab
~HSCT from the haploidentical donor, ex vivo depleted of alpha/beta T lymphocytes"
15855209|NCT04000685|Other|Yoga exercise program|Yoga exercise program will be applied two sessions per week, totally eight week.
15855210|NCT04000685|Other|Spinal stabilization exercise program|Spinal stabilization exercise program will be applied two sessions per week, totally eight week.
15855211|NCT04000685|Other|Aerobic walking program|Aerobic walking program will be applied two sessions per week, totally eight week.
15855212|NCT04000672|Procedure|3D printed patient specific metal jigs (PSI jig)|PSI jig is created based on the pre-operative CT image. Standard medial open wedge osteotomy described previously is performed. Incision is made in the midway between posteromedial border of the tibia and medial aspect of the tibial tuberosity. Sartorius fascia is cut and retracted medially to expose the medial collateral ligament (MCL). Then the PSI jig is positioned onto the tibia. Due to the jig patient specific design (individually based on each patient's CT image), it can fit closely to the proximal tibia. The slot opening on the PSI jig corresponds to 4 cm below the medial joint line and the slot design allow the sawblade cut direction toward the safe zone of the lateral cortex under fluoroscopy. The PSI Jig is removed after the bone cut completed and would not retain in patient's body.
15855213|NCT04000672|Procedure|HTO with navigation|In brief, an incision is made in the midway between posteromedial border of the tibia and medial aspect of the tibial tuberosity. Sartorius fascia is cut and retracted medially to expose the medial collateral ligament (MCL). Two to three K-wires are placed 4 cm below the medial joint line toward the safe zone (an area between the tip of the fibular head and the remnant of fibular head epiphysis line) of the lateral cortex under fluoroscopy and osteotomy is done below and parallel to the k-wires using an oscillating saw leaving the lateral 10 mm intact.
15855214|NCT04000659|Device|Episealer Knee System|The Episealer Knee System is comprised of individualized endoprosthetic resurfacing implants and implantation tools (Episealer Toolkit). The implants are designed to replace the articulating surface which has been damaged due to femoral knee chondral and osteochondral defects.
15855215|NCT04000659|Procedure|Microfracture|Microfracture is a minimally invasive surgical technique developed to repair defects in articular cartilage and reduce pain in the knee joint. Microfracture techniques are described in the orthopedic literature and are performed arthroscopically.
15855216|NCT04000646|Other|standard care|standard care non-pharmacologic interventions during anesthesia induction
15855217|NCT04000646|Other|breath-controlled app|breath-controlled app and custom-designed tablet (equipped with a breathing sensor)
15855218|NCT04000633|Drug|Lidocaine 2%|the patients of this group will recieve nebulization of 5 ml of 2% lidocaine prior to induction of general anesthesia
15855219|NCT04000633|Drug|Normal saline|Normal saline
15855220|NCT04000620|Procedure|surgery|treatment intent surgery
15855221|NCT04000620|Procedure|punture|diagnostic punture
15855222|NCT04000607|Device|Atrial Shunt|Transcatheter treatment of symptomatic left heart failure patients
15855223|NCT04000594|Drug|RO7234292 (RG6042)|RO7234292 (RG6042) will be administered in two IT doses of the same dose level at an interval of 28 days during the treatment period (Day 1 and Day 29). Each dose of RO7234292 (RG6042) will be administered as a single IT bolus injection.
15855224|NCT04000581|Other|Best Practice|Receive standard of care
15855225|NCT04000581|Other|Physical Activity|Walk for minimum 30 minutes per day
15855226|NCT04000581|Other|Questionnaire Administration|Ancillary studies
15855227|NCT04000568|Other|Respiratory support: NAVA -NIV and PC-NIV|The infants enrolled will receive respiratory assistance by NAVA-NIV and PC-NIV in a randomized order
15855228|NCT04000555|Drug|Oral Vancomycin|Oral vancomycin 125mg twice a day prescribed for the duration of antibiotics
15855229|NCT04000555|Other|Placebo|Matched placebo twice a day prescribed for the duration of antibiotics
15855230|NCT04000542|Other|Pharmacist Intervention|The pharmacist will record a 30 second rhythm strip from patients using the KardiaMobile device and calculate the QTc interval using the Bazett calculation formula. The pharmacist will discuss the result with the patient and if necessary, will contact the prescriber to effect a medication change. If the QTc interval is greater than the 99th percentile, (470 ms for males, 480 ms for females) the pharmacist must contact the prescriber. The pharmacist will record any prescription changes which resulted from the intervention and the prescriber response. The pharmacist will email the rhythm strip (with study participation number) to a secure email at the Northeast Iowa Family Practice Center (NEIFPC). Rhythm strips will be archived for future potential research evaluation in a secure, electronic file.
15855231|NCT04000529|Drug|TNO155|Capsule
15855232|NCT04000529|Drug|Spartalizumab|Concentrate for solution for infusion
15855233|NCT04000529|Drug|Ribociclib|Capsule and tablet
15855234|NCT04000516|Behavioral|Time restricted feeding|Restricting the eating window to about 8 hours a day, during waking hours.
15855261|NCT04000295|Drug|Etoposide|Subjects receive Etoposide capsule orally, d1-14, q3w, Dosage form: capsule, Strength: 50 mg/d
15855262|NCT04000295|Drug|Paclitaxel|Subjects receive Weekly Paclitaxel, intravenously, d1, d8, d15, q3w, Dosage form: injectable, Strength: 80 mg/m2
15855235|NCT04000503|Behavioral|Self-collected HPV testing for cervical cancer screening|Self-collection cervical cancer screening, STI screening, and education on HIV by a community health worker. Women who test positive for high-risk HPV types will be referred to a designated health centre for VIA follow-up and treatment if indicated.
15855236|NCT04000490|Other|SCARE Score|Predictive Score of acute coronary syndrome during the medical assessment of chest pain
15855237|NCT04000477|Device|Cytobrush|the brush would be inserted in full until the display of the brush in the endocervical canal disappears. A neck quadrant scan (= quarter turn) will be performed from front to back while simultaneously rotating the brush clockwise, for a total of 3 laps. This would represent 4 sweeps per turn, ie 12 sweeps in total
15855238|NCT04000477|Device|Kevorkian curette|the colposcopist holds the curette horizontally and scrapes the endocervical canal all the way around. He realizes 1 small firm and linear movement by quarter turn or 4 movements to realize a complete turn. During this act, the curette must remain inside the canal, and during its extraction, care should be taken not to rotate it so as not to spill the collected tissue contained in the basket of the curette. The tissue material thus obtained must be rapidly immersed in formalin
15855239|NCT04000464|Behavioral|CLIPP|Diabetes Prevention program and Comprehensive Lifestyle Improvement Program consisting of low calorie diet, physical activity, sleep optimization and stress management
15855240|NCT04000451|Device|oxyhydrogen|Hydrogen/oxygen mixed gas inhaled(proportion 2:1),3 L/min . 1 hour each time,twice a day(BID).Test Duration is seven days
15855241|NCT04000451|Device|Oxygen|oxygen inhaled,3 L/min . 1 hour each time,twice a day(BID).Test Duration is seven days
15855242|NCT04000451|Drug|Conventional treatment|Bronchodilator (LABA,LAMA) with or without ICS.Conventional treatment is invariable with which was given to COPD patients in seven days before the study
15855243|NCT04000438|Drug|DF01|The subject receives sc injections of tafoxiparin solution once daily for up to 7 days until labor induction or spontaneous onset of labor. Induction is done according to clinical practice; 1st balloon, 2nd PGE1
15855244|NCT04000438|Drug|PL1|The subject receives sc injections once daily of placebo solution for up to 7 days until labor induction or spontaneous onset of labor. Induction is done according to clinical practice; 1st balloon, 2nd PGE1
15855245|NCT04000425|Combination Product|AVENIO ctDNA surveillance kit|AVENIO circulating tumor DNA (ctDNA) Analysis Kits is a portfolio of three next-generation sequencing (NGS) liquid biopsy assay kits for oncology research: the AVENIO ctDNA Targeted Kit, Expanded Kit and Surveillance Kit.
15855246|NCT04000412|Device|CardioZ multifrequency impedance recording system|Patients will be submitted to mapping of both voltage and tissue impedance. The accuracy of the two maps identifying the extent and transmurality of the infarction will be assesssed by gadolinium imaging.
15855247|NCT04000399|Behavioral|BRITEPath|BRITEPath will guide co-located mental health clinicians in the use of an emotion regulation and safety planning app (BRITE) to be loaded on the phone of depressed and suicidal adolescents in order to improve depression and reduce the likelihood of a suicide attempt.
15855248|NCT04000386|Other|zinc oxide nanoparticles coated socks|zinc oxide nanoparticles coated socks were given to subjects for 2 weeks
15855249|NCT04000386|Other|placebo socks|placebo socks were given to subjects for 2 weeks
15855250|NCT04000373|Device|Ekso GT™ exoskeleton|The rehabilitation treatment will consist of 3 sessions per week for 8 weeks, for a total of 24 sessions. Missed sessions will be made up if possible. Each session will be scheduled for 60 minutes, and will consist of stretching, overground gait training, and gait training with the study device. Rest periods will be provided as necessary during the training visits.
15855251|NCT04000360|Other|High-Intensity Aerobic Exercise|The home-based exercise group will receive a Peloton indoor cycle delivered to their home and a heart rate monitor strap. Participants will be asked to cycle 3x/week for 12 months on their bike with their heart rate monitor at an aerobic intensity between 60-80% of heart rate reserve with a target cadence between 80-90 revolutions per minute (RPMs). Additionally, participants (both groups) will receive activity monitors to monitor their daily activity levels.
15855252|NCT04000347|Drug|2.5% benzoyl peroxide gel|2.5% benzoyl peroxide gel was given to patients for 2 weeks
15855253|NCT04000347|Drug|5% benzoyl peroxide gel|5% benzoyl peroxide gel was given to patients for 2 weeks
15855254|NCT04000334|Other|MAP increased to optimize cerebral blood flow|MAP will be increased to 90-100 mmHg with norepinephrine. If TCD is still abnormal with a MAP of 90-100 mmHg, MAP will be increased to 100-110 mmHg. At each step, all CBF determinants will be recorded as well as cardiac output and Veinous jugular oxygen saturation (SvjO2). When TCD is normalized with no complications, MAP will be maintained at 90-100 or 100-110 mmHg during 24 hours.
15855255|NCT04000334|Other|MAP between 65 and 85 mmHg|MAP will be maintained between 65-85 mmHg, using a norepinephrine infusion as needed.
15855256|NCT04000321|Other|Windmill at 30 Minutes|The so-called windmill technique of placenta development for the management of the retained placenta involves the application of a continuous 360-degree umbilical traction force with centripetal rotation in such a way that it runs at the level of the introitus perpendicular to the direction of the birth canal. This rotation around a 360-degree traction plane is repeated slowly and continuously with a motion that resembles the motion of the wings of a windmill until the placenta can be safely delivered.
15855257|NCT04000321|Other|Windmill at 45 Minutes|The so-called windmill technique of placenta development for the management of the retained placenta involves the application of a continuous 360-degree umbilical traction force with centripetal rotation in such a way that it runs at the level of the introitus perpendicular to the direction of the birth canal. This rotation around a 360-degree traction plane is repeated slowly and continuously with a motion that resembles the motion of the wings of a windmill until the placenta can be safely delivered.
15855258|NCT04000308|Drug|Quadratus Lumborum Block type 2|The obstetrician (multiple, experienced clinicians) will infiltrate the wound (Pfannenstiel incision) subcutaneously at the end of surgery with 20 ml normal saline. Subsequently, a US-guided QLB using a linear/convex transducer will be performed by the anesthesiologist using 30 ml levobupivacaine 0.18% (20 ml 0.25% levobupivacaine + 10 ml normal saline) bilaterally (60 ml in total).
15855259|NCT04000308|Drug|Wound Infiltration|Participants will receive 20 ml levobupivacaine 0.25% infiltration in the surgical wound and US-guided QLB with 30 ml normal saline bilaterally (60 ml in total).
15855260|NCT04000295|Drug|Apatinib|Subjects receive Apatinib orally, Dosage form: tablet, Strength: 375 mg/d
15863069|NCT03937635|Other|Quality-of-Life Assessment|Ancillary studies
15855263|NCT04000282|Drug|SAR442085|Pharmaceutical form:Sterile lyophilized powder for reconstitution for infusion Route of administration: intravenous
15855264|NCT04000269|Device|Soterix MxN Neuromodulation device|Up to 2 mA stimulation to primary motor cortex for 10 sessions at 20min per session
15855265|NCT04000269|Device|Sham Stimulation|Uses slight stimulation initially then turns of and provides no stimulation after a few seconds.
15855266|NCT04000256|Behavioral|Activity based rehabilitation|Activity based rehabilitation for the upper extremity involves various gross and fine movements, reach and object transportation, and object manipulation. The rehabilitation equipment used during training will include gaming and instrumented training equipment, conventional table-top tasks, and exercise aids.
15855267|NCT04000243|Diagnostic Test|Endoscopic diagnosis of Hp|Detection of a regular arrangement of collecting venules (RAC) pattern in the lesser gastric curvature
15855268|NCT04000230|Behavioral|TCIT|"TCIT consists of the following:
~CDI Teach Session: Teachers will participate in two training workshops in Child-Directed Interaction (CDI) skills. Specifically, teachers will learn to use positive attention skills and active ignoring.
~CDI Coaching: Teachers will receive 90 minutes of CDI coaching in the classroom once or twice weekly for 6 total coaching sessions over a period of 4-6 weeks. The coach will observe the class and coach the teacher live using a microphone and bug-in-the-ear device.
~TDI Teach Session: Teachers will complete two training workshops in Teacher Directed Interaction (TDI) skills, which focus on increasing compliance and reducing disruptive behavior. Teachers will learn to present developmentally appropriate, direct, and clear instructions and consistent positive and negative consequences.
~TDI Coaching: Teachers will receive six 90-minute TDI coaching sessions once or twice weekly for 4-6 weeks."
15855269|NCT04000230|Behavioral|Booster|Teachers in the Intervention group will receive additional booster sessions during the second half of the school year. Booster sessions consist of coaching teachers in CDI and TDI skills. Teachers receive 4-8 booster sessions.
15855270|NCT04000217|Behavioral|Written Exposure Therapy|In this study, written exposure therapy is delivered in an online format with coaching from trained peer support specialists. Participants will complete 4-8 sessions, depending on their level of symptom reduction (i.e., allow for early termination when low symptom levels are achieved).
15855271|NCT04000217|Behavioral|Imaginal Exposure Therapy|Delivery of imaginal exposure in this study will mirror the procedures used in WET. It will be delivered in an online format with coaching from trained peer support specialists. Participants will complete 4-8 sessions, depending on their level of symptom reduction (i.e., allow for early termination when low symptom levels are achieved).
15855272|NCT04000204|Device|HYAJOINT Plus|60 mg / 3 ml cross-linked hyaluronan, SciVision Biotech Inc.
15855273|NCT04000204|Device|Durolane|60 mg / 3 ml cross-linked hyaluronan, Bioventus LLC.
15855274|NCT04000191|Procedure|MAC|Monitored anesthesia care (MAC) administered by anesthesiology and Injection of local anesthesia mixture of 1% lidocaine with epinephrine and 0.25% Marcaine by the operating surgeon.
15855275|NCT04000191|Other|Perianal ice application|Application of ice to the perianal area after the area is prepared with betadine, prior to injection of local anesthesia by the surgeon.
15855276|NCT04000178|Device|polyurethane stent|patients were prospectively enrolled in the study and stratified (non-randomly) into either group A - polyurethane - control group or group B - silicone - experimental group
15855277|NCT04000178|Device|silicone stent|silicone stent
15855278|NCT04000165|Drug|AG-348|This is a nonrandomized, doseescalating clinical study designed to assess the safety and tolerability of escalating doses of AG348 in subjects with sickle cell disease (SCD).
15855279|NCT04000152|Diagnostic Test|niPGT-A|"Two scenarios should be considered according to the results in the SBM analysis:
~The couple decides to transfer the blastocyst selected according to the SBM result (blastocyst prioritization system).
~The couple decides to biopsy the blastocysts (if SBM results show low euploidy score). This PGT-A analysis will be offered for free but the outcome of these transfers will be excluded for the analysis per completed protocol. However, all transfers will be included in the intention-to-treat analysis."
15855280|NCT04000152|Other|Morphology criteria|Embryos for transfer will be selected by the only applicable technique, the assessment of morphology according to Gardner´s criteria, which is the most standardized method.
15855281|NCT04000139|Drug|Standardized anthocyanin-rich extract|3g of anthocyanin-rich extract taken daily as: 3 doses of 2x 500mg. Treatment duration 56 days (8 weeks).
15855282|NCT04000139|Drug|Placebo|3g of placebo taken daily as: 3 doses of 2x 500mg. Treatment duration 56 days (8 weeks).
15855283|NCT04000126|Device|Pupil reflex dilation measurement (PRD)|Pupillary Reflex Dilation (PRD) measured for 60 s during orotracheal intubation using a video pupillometer
15855284|NCT04000126|Device|PPI (Pupillary Pain Index)|Pupillary Reflex Dilation (PRD) measured using a video pupillometer 5 min after orotracheal intubation
15855285|NCT04000126|Drug|lidocaine|1.5 mg/kg lidocaine/ 100ml 0,9% NaCl iv 10min before intubation
15855286|NCT04000126|Drug|Placebo|100ml 0,9% NaCl iv 10min before intubation
15855287|NCT04000126|Device|Bispectral Index (BIS)|Bispectral Index will be monitored to assess the depth of anaesthesia
15855288|NCT04000126|Device|HR|HR in beats/min will be measured by the electrocardiogram monitor
15855289|NCT04000126|Device|BP|BP will be measured automatically by an occluding upper arm cuff
15855290|NCT04000113|Device|laser acupuncture|low level laser emission on specific acupuncture points
15855291|NCT04000113|Device|Sham laser|Sham laser
15855292|NCT04000100|Procedure|ultrasound- guided supraclavicular brachial plexus block|"Patient lie down supine with head turned 45 degrees to the contralateral side and ipsilateral arm adducted gently by the assistant and the shoulder kept down with flexed elbow.
~After sterile preparation of the skin and the ultrasound probe (12 MHz probe) were used, the brachial plexus was visualized by placing the transducer in the sagittal plane in the supraclavicular fossa behind the middle-third of the clavicle. Two distinct appearances of the brachial plexus was seen at the supraclavicular region, it either appeared as 3 hypoechoic circles with hyperechoic outer rings or as a grape like cluster of 5 to 6 hypoechoic circles, located lateral and superior to the subclavian artery between the anterior and middle scalene muscles at the lower cervical region figure"
15855293|NCT04000087|Other|AI-enabled ECG-based Screening Tool|A novel artificial intelligence (AI)-enabled electrocardiogram (ECG)-based screening tool for improving the diagnosis and management of left ventricular systolic dysfunction.
15855294|NCT04000074|Behavioral|Telephonic Services|Provides linkage services to local programs that address the social determinants of health remotely via phone, email and/or fax
15855295|NCT04000074|Behavioral|In-Person Services|Provides linkage services to local programs that address the social determinants of health directly to the client during face-to-face visits as well as remotely via phone, email, etc.
15855296|NCT04000061|Other|medical chart review|data generated by medical review include Medical history, Medications at presentation, during hospitalization and at discharge, New York Heart Association (NYHA) class, Killip class, Electrocardiographic (ECG) data, echocardiographic data, Interventions (Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Graft (CABG), Implantable Cardioverter Defibrillator (ICD) implantation, Cardiac Resynchronization Therapy (CRT) Implantation), Outcome Information: all-cause death, HF hospitalizations
15855297|NCT04000061|Other|data generated by direct IT export|data generated by direct IT export include Anthropometric data (age, sex, height, weight), Vital signs, Laboratory data
15855298|NCT04000048|Genetic|sequencing of the complete exome|Once the pathological diagnosis is confirmed (WHO 2016), a tumor fragment will be selected and frozen for each lobe. DNA extraction will be performed for each fragment. The samples (4 different DNAs per GDBG corresponding to the DNA extracted from each of the 3 lobes and the blood DNA) will be sent to the Montpellier Genomix platform for sequencing of the complete exome.
15855299|NCT04000035|Other|Health and work environment information and processes|see arm/group description
15855300|NCT04000022|Device|intermittent theta burst stimulation (iTBS)|20 sessions of iTBS
15855301|NCT04000009|Drug|Pimavanserin|Pimavanserin 34 mg (provided as 2×17 mg tablets) administered orally as a single dose once daily
15855302|NCT03999996|Biological|Tetravalent Dengue Vaccine (TDV)|TDV subcutaneous injection
15855303|NCT03999996|Biological|Placebo|Normal Saline (0.9% NaCl) subcutaneous injection
15855304|NCT03999983|Other|Observational Prospective Registry|This is a prospective registry looking at patients admitted for stroke with evidence of Vertebral Artery Origin Stenosis. Patients clinical outcomes will be collected at 30 days and 1-year post-treatment and angiographic outcomes at 1-year post-treatment
15855305|NCT03999970|Other|Sand fly bite|Comparison between sand fly bites from two different species (Phlebotomus papatasi and Phlebotomus duboscqi)
15855306|NCT03999957|Other|Telehealth web conferencing|Pediatric patient specific case discussions for enrolled pediatric patients at hospice staff interdisciplinary team meeting every 15 days for 60 min sessions via telehealth
15855307|NCT03999944|Device|positive airway pressure system|Positive Airway Pressure System
15855310|NCT03999905|Behavioral|Counseling training|Online training using Moodle.
15855311|NCT03999892|Behavioral|ACHIEVE|The investigators will test two modules of the adapted video-assisted curriculum format of 45 to 60-minute multipurpose classes, which will include a segment on group weight management (~20-30 minutes) and group exercise (~20-30 minutes). Within each module, the group weight management topic varies by week, and within each week the content of the three weight management groups builds gradually and is purposely repeated. Within each module, the group exercise classes will focus on mild to moderate intensity aerobic exercise using an exercise video. In this pilot study, a trained study interventionist will deliver the ACHIEVE-D curriculum.
15855312|NCT03999879|Diagnostic Test|Measure of OxPhos upregulation|OxPhos upregulation [i.e., lower phosphocreatine (PCr)-to-ATP ratio levels] in the PET AG mask. PIB+ NL subjects will show OxPhos downregulation (i.e. increased PCr/ATP ratio that indicate the presence of metabolically inert PCr that cannot be used as ATP) when compared to PIB- NL subjects in the PETAG mask
15855313|NCT03999879|Diagnostic Test|lactate (measured with 1H-MRSI)|PIB+ NL subjects will show increased levels of lactate (measured with 1H-MRSI) when compared to PIB- NL subjects in the PETAG mask.
15855314|NCT03999866|Device|airtraq|airtraq videolaryngoscope
15855315|NCT03999866|Device|mcgrath mac x-blade|mcgarth mac videolaryngoscope
15855316|NCT03999866|Device|storz c-mac|storz c-mac videolaryngoscope
15855317|NCT03999866|Device|storz d-blade|storz d-blade video laryngoscope
15855318|NCT03999853|Dietary Supplement|BKR-017|500 mg butyrate tablets
15855319|NCT03999853|Other|usual care|usual care
15855320|NCT03999840|Drug|cemdisiran|Cemdisiran has been designed to reduce the level of C5 mRNA in the liver, thereby reducing levels of circulating C5 protein, inhibiting terminal complement pathway activity, and preventing formation and deposition of the MAC (C5-b9) on endothelial cells in the kidney.
15855321|NCT03999840|Drug|Placebos|The control drug for this study will be a placebo (sodium chloride 0.9% w/v for SC administration). Placebo will be prepared and labelled identically to cemdisiran.
15855322|NCT03999827|Other|Low Glycaemic Index Diet|Adherence to a diet which limits carbohydrate intake to 40-60 g/day, but carbohydrates must have a glycaemic index of less than 50. Fat and protein intake is encouraged, with approximately 60% of calorie intake as fat.
15855323|NCT03999801|Drug|RGX-314|anti-VEGF fab
15855324|NCT03999788|Procedure|lumbar puncture and blood withdrawal|lumbar puncture performed to detect OCB for diagnostic purposes and blood withdrawal for SNP screening
15855325|NCT03999788|Procedure|Intermittent theta burst stimulation (iTBS) therapeutic protocol for spasticity|iTBS will be delivered over the scalp site corresponding to the leg area of primary motor cortex contralateral to the affected limb. The active motor threshold (AMT) will be defined as the minimum stimulation intensity required to evoke a liminal motor potential from the Soleus muscle during voluntary contraction. The stimulation intensity will be about 80% of AMT. The iTBS stimulation protocol consists of 10 bursts, each burst composed of three stimuli at 50 Hz, repeated at a theta frequency of 5 Hz every 10 s for a total of 600 stimuli (200 s). If no MEP will be detectable from the contralateral leg, the site of stimulation will be determined as symmetrical to the motor hot spot. If no MEP will be detectable even from the contralateral leg the coil will be held tangentially to the scalp with its centre placed 1 cm ahead and 1 cm lateral from CZ (10-20 EEG system). In these cases, stimulation intensity will be set to 50% of the maximum stimulator output.
15855326|NCT03999775|Dietary Supplement|Calcium, vitamin D and bioactive collagen peptides supplement|
15855327|NCT03999775|Dietary Supplement|Calcium and vitamin D supplement|
15855329|NCT03999749|Drug|Ipilimumab|4 induction doses (during the 2 treatment cycles) at a dose of 1 mg/kg intravenously (IV) every 3 weeks, 4 times during the 12-week induction period, concurrent with nivolumab at 3 mg/kg administered at the same interval
15855330|NCT03999749|Drug|Nivolumab|administered first at a dose of 3 mg/kg;
15855331|NCT03999749|Drug|Tocilizumab|Administered intravenously for each 42-day induction treatment cycle.
15855332|NCT03999736|Device|transcranial direct current stimulation using a Soterix mini-CT device|TDCS is used to non-invasively stimulate the brain through the application of electrical currents to a small region of the scalp using a battery-powered stimulator (Soterix Medical 2018) with rubber electrodes and conductive material (saline-soaked sponges). Both electrodes are attached to the scalp with a band. The stimulation points will be located using the 10-20 system of electroencephalogram (EEG) electrode location (localization carried out using a bespoke head strap). The electrode size of the stimulator used in this study is large (25 cm2) and the current strength used is low (2 mA) resulting in very low current density (0.08 mA/cm2). This protocol applies no more than 30 minutes of stimulation in a single session, which is typical for experimental studies (Brunoni et al. 2015; Loo et al. 2017). TDCS is an investigational device and has proceeded with a non-significant risk designation in many past trials and not required an investigational device exemption from the FDA.
15855333|NCT03999723|Dietary Supplement|Vitamin C|Oral vitamin C (ascorbic acid) 1000 mg daily will be administered from day 1 in the 1st AZA cycle (D1/C1) and continued until discontinuation of AZA or EOS as combination treatment.
15855334|NCT03999723|Dietary Supplement|Placebo|Placebo capsules (two capsules once daily) will be administered from day 1 in the 1st AZA cycle (D1/C1) and continued until discontinuation of AZA or EOS.
15855335|NCT03999710|Radiation|Radiation Therapy|Treatment will consist of 60 Gy in 30 fractions to fields encompassing gross tumor and lymph nodes.
15855336|NCT03999710|Drug|Durvalumab|A dose of 1500mg (for patients >30kg in weight) will be administered using an IV bag containing 0.9% (w/v) saline or 5% (w/v) dextrose, with a final durvalumab concentration ranging from 1 to 15 mg/mL, and delivered through an IV administration set with a 0.2- or 0.22- μm filter.
15855337|NCT03999697|Drug|Autologous chimeric antigen receptor T cell transfusing agent targeting CD22|The enrolled patients will receive autologous-derived CD22-targeted CAR-T cells in 1 day with 100% of the total expected dosage after receiving lymphodepleting chemotherapy
15855338|NCT03999684|Drug|Tretinoin|ATRA control normal cell growth, cell differentiation (the normal process of making cell different from each other), and cell death during embryonic development and in certain tissues later in life. Retinoids effects on the cells are controlled by receptors on the nucleus of each cell (nuclear receptors)
15855339|NCT03999671|Other|Educational|Traditional method of nursing care with what is done every day, with the method through the nursing process using nursing language as a nursing diagnosis, classification of nursing interventions, and nursing outcomes.
15855340|NCT03999671|Other|Maneuver control|Verify that the control and intervention group developed the assigned activities in each case.
15855341|NCT03999658|Biological|STI-3031|anti-PD-L1 antibody
15855342|NCT03999645|Procedure|Early laparoscopic cholecystectomy|within 72h from symptom onset
15855343|NCT03999645|Procedure|Late laparoscopic cholecystectomy|after 72h up to seven days from symptom onset
15855344|NCT03999632|Other|Dietary modification with introduction of Mankai|Substituting the standard high protein, low carbohydrate preoperative shake during the preoperative liquid diet with Wolffia Globosa (Mankai) shake consisting of 16 oz of skim milk + 1 frozen cube of Wolffia Globosa (Mankai) +/- sugar substitute.
15855345|NCT03999619|Behavioral|Move 2 Learn|10-week (1 hour/week) program designed to target fundamental movement and pre-literacy skills with active parent involvement.
15855346|NCT03999606|Behavioral|Music Training - Choir participation|"Sixty participants, ages 50-65, will be recruited to partake in this study and will be randomly assigned to two groups:
~participants in the experimental group will join a weekly on-line choir via Zoom, for ten weeks, directed by a professionally trained conductor from USC Department of Choral Music. The group practice will be accompanied by individual singing lessons (online or CDs) for home practice. Participants in the control group will be provided with weekly remote mindfulness lessons also on an online platform."
15855347|NCT03999593|Procedure|Resection of perihilar cholangiocarcinoma|Resection of perihilar cholangiocarcinoma
15855348|NCT03999580|Drug|vitamin D3|"3000 or 4000 UI/ day:
~Weight at inclusion < 40 kg : 1 ml per day of the selected concentration at induction and 1ml per day of the selected concentration at maintenance.
~Weight at inclusion ≥ 40 kg : 1 ml per day of the selected concentration at induction and 1 ml per day of the selected concentration at maintenance
~600 UI/ day:
~Weight at inclusion < 40 kg :1 ml per day of the selected concentration (600 IU) at induction and 1 ml per day of the selected concentration (600 IU) at maintenance.
~Weight at inclusion ≥ 40 kg : 1 ml per day of the selected concentration (600 IU) at induction and 1 ml per day of the selected concentration (600 IU) at maintenance"
15855349|NCT03999567|Other|Pen and Paper Digit Symbol Substitution Test (DSST)|The DSST is a paper-and-pencil cognitive test presented on a single sheet of paper that requires a subject to match symbols to numbers according to a key located on the top of the page. The subject copies the symbol into spaces below a row of numbers. The number of correct symbols within the allowed time, usually 90 to 120 seconds, constitutes the score.
15855350|NCT03999567|Other|Electronic Digit Symbol Substitution Test (DSST)- (a.k.a. Codebreaker)|Code breaker is the mobile/electronic version of the pen and paper DSST which is capable of identifying deficits in the domains of executive function, processing speed and attention/concentration, and takes 2 minutes to complete. Six symbols are numbered consecutively. Users are presented with a series of numbers that they must then match with the correct corresponding symbol as quickly as possible. Users are scored on speed and accuracy.
15855351|NCT03999554|Biological|LD Sing2016 M2SR H3N2 influenza vaccine|This group will receive a low dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
15855352|NCT03999554|Biological|MD Sing2016 M2SR H3N2 influenza vaccine|This group will receive a medium dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
15855353|NCT03999554|Biological|HD Sing2016 M2SR H3N2 influenza vaccine|This group will receive a high dose of the Sing2016 M2SR H3N2 monovalent influenza vaccine administered intranasally.
15855354|NCT03999554|Biological|LD Bris10 M2SR H3N2 influenza vaccine|This group will receive a low dose of the Bris10 M2SR H3N2 monovalent influenza vaccine administered intranasally.
15855356|NCT03999541|Other|Freeze-all policy|A policy of freezing all the embryos followed by subsequent thawed frozen embryo transfer
15855357|NCT03999528|Diagnostic Test|14-3-3η Protein assay|blood sampling for assessment of serum 14-3-3η Protein
15855358|NCT03999515|Drug|Abiraterone Acetate|Given PO
15855359|NCT03999515|Drug|Enzalutamide|Given PO
15855360|NCT03999515|Drug|Erdafitinib|Given PO
15855361|NCT03999502|Device|Endomina|The procedure will be performed under general anesthesia with tracheal intubation. Endomina will be introduced into the stomach over a guidewire and then fixed to the endoscope. The procedure will include at least one suture of the gastric cardia to tighten it. Patients will be kept overnight after the procedure.
15855362|NCT03999476|Device|ambu ascope2|nasal route intubation by the device in fixed cancer tongue patients
15855363|NCT03999476|Device|fibreroptic bronchoscope|nasal route intubation by the device in fixed cancer tongue patients
15855364|NCT03999450|Behavioral|brief motivational intervention (BMI)|The intervention typically takes 45 minutes to administer and is designed to enhance motivation to change and includes the following components: establishing rapport, asking permission to discuss substance use and providing feedback regarding the substance use assessment, exploring personal consequences of drug use, eliciting the gap between real and desired quality of life, and discussing readiness to change. The therapist then negotiates a written action plan, during which the subject is supported with empathy and verbal reinforcement.
15855365|NCT03999450|Behavioral|cognitive behavioral therapy|This evidence-based, online, Computer Based Training for Cognitive Behavioral Therapy (CBT4CBT) program covers six lessons: 1) changing patterns of use, 2) coping with craving, 3) refusing drugs, 4) problem-solving skills, 5) changing drug-related thoughts, and 6) improving decision-making. The program is designed to be user-friendly and includes videotaped instructions and examples, interactive assessments, and practice exercises.
15855366|NCT03999437|Drug|TERBINAFINE HYDROCHLORIDE (1%)|Topical liquid solution
15855367|NCT03999437|Drug|BUTENAFINE HYDROCHLORIDE (1%)|Topical liquid solution
15855368|NCT03999437|Drug|Vehicle Control|Topical liquid solution
15855369|NCT03999424|Biological|autologous human Schwann cells|Schwann cells harvested from the sural nerve and debrided, injured sciatic nerve of the participant will be autologously transplanted along sural nerve autografts wrapped in a collagen matrix
15855370|NCT03999411|Drug|Nicoderm C-Q Transdermal Product|6 weeks of GlaxoSmithKline Nicoderm CQ (NRT)
15855371|NCT03999411|Behavioral|Adherence to Antiretroviral Therapy Counseling|Brief counseling on adhering to antiretroviral therapy with self-help materials.
15855372|NCT03999411|Behavioral|Behavioral Smoking Cessation Counseling|One time face-to-face smoking cessation counseling and 2 follow-up phone calls.
15855373|NCT03999411|Behavioral|"Crave-to-Quit app"|"Evidence-based mindfulness smoking cessation smartphone app (Crave-to-Quit) adapted from an in-person mindfulness training relapse prevention smoking cessation intervention."
15855374|NCT03999411|Behavioral|"vDOT emocha app"|"Video Directly Observed Therapy (vDOT) smartphone app (emocha) that allows participants to take a video of themselves taking medication to ensure adherence."
15855375|NCT03999398|Procedure|Percutaneous coronary intervention (PCI)|Participants are treated with a PCI and stent implantation in a venous graft (previously implanted during the CABG operation)
15855376|NCT03999385|Behavioral|Mindful Self-Compassion (MSC)|The MSC program was developed by Christopher K. Germer, PhD and Kristin Neff, PhD.
15855377|NCT03999372|Biological|Hyaluronan binding system|Hyaluronan binding system for sperm selection for ICSI procedures (PICSI)
15855378|NCT03999372|Other|ICSI|Normal ICSI procedure
15855379|NCT03999359|Other|Home-based Metacognitive Therapy|Home-based metacognitive therapy (Home-MCT) is a facilitated self-help manual comprising six modules which participants will complete at their own pace over approximately 6 weeks. Participants will have an initial appointment with a Home-MCT trained cardiac rehabilitation staff members (face to face or by telephone). In addition, they will receive two telephone calls from trained cardiac rehabilitation staff members over the course of the intervention to offer support with completing the modules of the self-help manual.
15855380|NCT03999346|Other|retrospective analysis of the Swiss Trauma Registry data|retrospective analysis of protectively documented registry data based on data completeness, patient outcomes, patient characteristics
15855381|NCT03999333|Device|Virtual Reality (Oculus Go)|Participants will self-administer virtual reality intervention, in addition to standard of care treatment for pain. There will be 6 weeks of weeks of monitoring period (2 weeks before, 4 weeks during, and 2 weeks after the virtual reality intervention).
15855382|NCT03999320|Other|Sophrology sessions|8 sophrology sessions, approximately 60 minutes each, spread over 12 months
15855383|NCT03999320|Other|usual care|usual care
15855384|NCT03999307|Radiation|Low-Level Laser Therapy (LLLT)|LLLT will be applied in this group
15855385|NCT03999307|Procedure|Flapless Corticopunture|Small holes in the cortical bone will be achieved using 1-mm diameter round surgical Tungsten bur
15855386|NCT03999307|Other|Control|Typical orthodontic treatment with no LLLT or flapless corticopuncture
15855387|NCT03999294|Other|BMGIM Music Therapy Method|The BMGIM method is today one of the models recognized by the international music therapy community, deserving this distinction those approaches that develop a solid theoretical and practical body, with specific training programs as training for new therapists, and that also promote the scientific research as a way to develop the method and Music Therapy.
15855388|NCT03999281|Other|Human Allograft (Theraskin)|Biologically active cryopreserved human skin allograft (Theraskin) was used on both cohorts, both diabetic foot ulcer and venous leg ulcer.
15855389|NCT03999268|Behavioral|I-START|Designed as a supplementary educational tool for patients on insulin therapy, I-START includes an injection plan to reinforce the knowledge and behaviors that users have been taught by their health care provider. This is done through eight modules created for the benefit of new and experienced insulin users, and those using pens or vial/syringes. The modules address a variety of topics pertinent to insulin therapy, including overcoming psychosocial barriers, injection techniques and best practices, managing hypo- and hyperglycemic events, monitoring blood glucose and troubleshooting and problem solving. At the end of each module, users can self-evaluate their confidence in mastering the information presented. This gives them the ability to move forward into the next module, repeat material already presented and/or save features of the modules that they would like to revisit at another time.
15855390|NCT03999268|Behavioral|Standard Insulin Administration Education|Standard best practices for training patients to administer insulin therapy include 1) a thorough patient assessment prior to therapy initiation to address barriers, including evaluation for diminished cognitive capacity or other problem that may impair safe insulin self-administration, and assessment of health literacy and numeracy skills; 2) observation of a patient's injection practice, with re-education provided as needed; 3) use of appropriate language is necessary when teaching injection technique; 4) dose preparation, which includes inspecting the insulin dose for accuracy (following manufacturer instructions); and 5) review of signs, symptoms and treatment of hypoglycemia must be included as a critical component of the training.
15855391|NCT03999255|Procedure|combined respiratory support (CRS)|combined respiratory support (CRS) which consisted of reduction of tidal volume to 250-300 ml and respiratory rate to 4-5 per minute with transcatheter high-frequency jet ventilation (HFJV) through an endotracheal tube with a respiratory cycle frequency (RCF) of 300 per minute and maintained during RIRS.
15855392|NCT03999229|Drug|SNO|S-nitrosylating agent (SNO) Inhalation
15855393|NCT03999229|Drug|Normal Saline|Normal Saline transfusion
15855394|NCT03999229|Drug|Red Blood Cell|Blood transfusion (RBCs)
15855395|NCT03999216|Drug|Loop Diuretics vs. loop + thiazide diuretics|Participants will receive the diuretic type as determined by the randomized group assignment starting within the first 24 hours of hospital admission and continuing for up to 72 hours. All other treatments are left to the discretion of the treatment team, as this is a pragmatic randomized trial.
15855396|NCT03999203|Drug|Citric acid|Citric Acid cough challenge to be administered to assess the cough reflex sensitivity in patients
15855397|NCT03999203|Device|Leicester Cough monitor|Ambulatory cough monitor to assess cough frequency over a 24 hour period
15855398|NCT03999203|Other|fractional exhaled nitric oxide testing (FeNO)|Measurement of exhaled nitric oxide to give an indication of airway inflammation
15855399|NCT03999203|Other|Patient reported outcome measures|A number a patient reported outcome measures will be administered including: Asthma control questionnaire (ACQ-5), mini Asthma Quality of Life Questionnaire (mini AQLQ), Leicester Cough Questionnaire (LCQ), Cough Quality of Life Questionnaire (CQLQ), Cough Hypersensitivity Questionnaire (CHQ) and visual analogue scales for severity og cough (VASc) and Urge to Cough (VASu)
15855400|NCT03999190|Drug|NPA radiotracer|"[11C]NPA radiotracer, 2 injection per subject
~Antagonist ([11C]raclopride) and agonist ([11C]NPA) radiotracer will be used sequentially to measure binding potential (BPND) under baseline conditions and 3-hours following oral administration of 0.5 mg/kg amphetamine in the same 30 medication free subjects with schizophrenia (MF-S) and 30 healthy control subjects (HC)."
15855401|NCT03999190|Drug|Raclopride radiotracer|"[11C]raclopride radiotracer, 2 injections per subject
~Antagonist ([11C]raclopride) and agonist ([11C]NPA) radiotracer will be used sequentially to measure binding potential (BPND) under baseline conditions and 3-hours following oral administration of 0.5 mg/kg amphetamine in the same 30 medication free subjects with schizophrenia (MF-S) and 30 healthy control subjects (HC)."
15855402|NCT03999190|Drug|Dextroamphetamine|Dextroamphetamine, one oral administration of 0.5 mg/kg per subject Antagonist ([11C]raclopride) and agonist ([11C]NPA) radiotracer will be used sequentially to measure binding potential (BPND) under baseline conditions and 3-hours following oral administration of 0.5 mg/kg amphetamine in the same 30 medication free subjects with schizophrenia (MF-S) and 30 healthy control subjects (HC).
15855403|NCT03999177|Behavioral|Kinect-TOLF Training System|This system will teach patients to perform the lymphatic exercises correctly. Like playing the video games, patients follow the avatar model in the video to perform the lymphatic exercises. The Kinect system can automatically detect whether a user is performing the set of lymphatic exercises correctly in real time and provide instantaneous feedback to the user, thus enhancing patients' self-efficacy to perform the lymphatic exercises correctly. Patients will be asked to conduct two types of usability testing: heuristic evaluation and end-user testing.
15855404|NCT03999164|Drug|[18F]DPA-714 Positron Emission Tomography Scan|All patients will undergo a [18F]DPA-714 PET scan of the brain 2 weeks and 2 months following moderate to severe traumatic brain injury to quantify neuroinflammation.
15855405|NCT03999151|Behavioral|Exercise and Diet|This Phase 2, open-label, four-arm randomized controlled trial (RCT) will investigate the effects of a 2-year behavioral program providing access to educational materials + clinical texting program (Arm A) + participant portal, text messaging, and coaching (Arms B-D) in 200 men with histologically confirmed low-risk prostate adenocarcinoma who choose radical prostatectomy as treatment.
15855406|NCT03999138|Diagnostic Test|MRI|MRI studies (non-contrast) will consist of a free-breathing localizer (~10 seconds) followed by a free-breathing yarnball water density scan, for a total MRI time of < 3 minutes.
15855407|NCT03999125|Drug|Aflibercept,|Primary therapy will be with Aflibercept. If the edema does not respond to the intervention, the patient will be treated with Ranibizumab, Dexamethasone Implant or Laser.
15855408|NCT03999125|Drug|Ranibizumab Injection|Primary therapy will be with ranibizumab. If the edema does not respond to the intervention, the patient will be treated with Alfibercept, Dexamethasone Implant or Laser.
15855409|NCT03999125|Drug|Ozurdex Drug Implant Product|Primary therapy will be with Ozurdex. If the edema does not respond to the intervention, the patient will be treated with Alfibercept, Ranibizumab or Laser
15855410|NCT03999112|Other|Metacognitive Reflection and Insight Therapy (MERIT)|A psychological therapy aiming to increase the ability of individuals to synthesise perceptions about themselves and others; to then form complex narratives which recognise the occurrence of these within particular social contexts; and to use these to form responses to psychological problems.
15855411|NCT03999099|Drug|Suvorexant 20 mg|Suvorexant at a high dose (20 mg)
15855412|NCT03999099|Drug|Suvorexant 10 mg|Suvorexant at a low dose (10 mg)
15855413|NCT03999099|Drug|Placebo oral tablet|Placebo
15855414|NCT03999086|Procedure|Intervention|We will utilize thromboelastography to discern when to transfuse blood products in the setting of multi-level spinal fusion
15855415|NCT03999086|Other|Control Group|Laboratory analysis to guide transfusion
15855416|NCT03999073|Other|Ultrasound measurement|Ultrasound measurement
15855417|NCT03999060|Device|Electric Current Stimulation|Electric stimulation with a Digitimer DS7AH HV Current Stimulator delivered with 4 shielded electrodes mounted on the participants head
15855418|NCT03999047|Diagnostic Test|PRISMA score|Screening for frailty using PRISMA-7
15863070|NCT03937635|Other|Questionnaire Administration|Ancillary studies
15855419|NCT03999034|Diagnostic Test|questionnaire completion|Every patient (140) and healthy control (400) will fill in all the tests and questionnaires, except FSS, in a random order during a single appointment. The FSS will be fill in by patients only. All 400 healthy controls will be divided in 20 groups of 20 people, according to gender, age (5 classes: 18-33, 34-43, 44-54, 55-64, and more than 65 years old), and level of education (graduated or not). 60 of them will pass the XO test at the beginning and again at the end of the consult to investigate the test-retest effect.
15855420|NCT03999021|Drug|NAC effervescent tablets|After completing the pretreatment visits, all patients will enter into the treatment phase where patients will receive 1800 mg of NAC effervescent tablets twice a day. The patients will be followed up every 3 months for 2 years. Therefore, there will be a total of 9 treatment visits (baseline, months 3, 6, 9, 12, 15, 18, 21 and 24).
15855421|NCT03999008|Drug|Budesonide Oral|"The subjects will be included at time of the first dilation for an anastomotic stricture.
~Basal physical exam and clinical evaluation (weight and height, dysphagia score, gastroesophageal reflux, feeding problems, respiratory symptoms, other symptoms).
~Randomization will be conducted by centre. Because long gap esophageal atresia, high tension anastomosis and history of anastomotic leak are reported as risk factors for occurrence of anastomotic strictures, a stratification at randomization will be performed according to these criteria in each centre.
~OVB or placebo will be given by the parents and started the day of the dilation at the first meal after recovering of the dilation and anesthesia.
~Parents will be asked to bring the empty caps which will be counted for assessment of compliance."
15855422|NCT03999008|Drug|Placebos|Apple Sauce 5 mL+ 1 mL saline
15855423|NCT03998995|Device|Immersive Virtual Reality|"An Oculus Rift VR Headset and a set of Oculus Touch Controllers was used as interactivity device. Two scenarios of IVR rehabilitation game were offered to the patients: 1) Archery based on behind-the-neck overhead press, using a quiver on the user back to encourage bending their arm and firing the arrow to help with stretching exercises and 2) Climbing based on an overhead arm raise exercise.
~Each child will took part in a single IVR trial during their rehabilitation care with the physiotherapist, supported by IP, the games expert/researcher. Timing of participation was approximately 15 minutes of trial with each scenario of game. A short interview was conducted with each child and their parent (together) after each trial, and a focus group was conducted with the clinical staff."
15855424|NCT03998982|Drug|Glycyrrhetinic Acid|Compound glycyrrhizin tablets 75 mg three times per day, 1 month
15855425|NCT03998982|Drug|Dexamethasone|HD-DXM (orally at 40 mg daily for 4d)
15855426|NCT03998969|Drug|Pantoprazole|Pantoprazole 40mg tablet
15855427|NCT03998969|Drug|DA-5204|DA-5204 tablet
15855428|NCT03998969|Drug|Placebo|Film-coated tablet manufactured to mimic DA-5204
15855429|NCT03998956|Procedure|CPVI|Circumferential PV isolation only
15855430|NCT03998956|Procedure|CPVI+BOX|Circumferential PV and BOX isolation
15855431|NCT03998956|Procedure|CPVI+BOX+SUB|Atrial substrate ablation apart from circumferential PV and BOX isolation
15855432|NCT03998930|Other|Clinical evaluation of consciousness by the Coma Recovery Scale Revised (CRS-R)|Paraclinical evaluation of consciousness by the brain-machine interface by measuring evoked potentials P300 auditory and vibrotactile and recording the EEG signal during a motor imaging task
15855433|NCT03998917|Diagnostic Test|Discrimination of neuromuscular alterations protocol|Patients will perform a hand grip fatigability test with their dominant hand, followed by a Timed Up and Go Test (TUG-Test), a Five-repetition sit-to-stand-test (5STS-Test) and a10 meters gait speed test.
15855434|NCT03998904|Procedure|Muscle preservation|Muscle preservation during graft preparation of hamstring graft
15855435|NCT03998904|Procedure|No muscle preservation|No muscle preservation during graft preparation of hamstring graft
15855436|NCT03998891|Other|restricted dietary salt intake|These patients after CRTd will receive a restricted dietary salt intake. To date, the salt intake will be 1500 grams daily.
15855437|NCT03998878|Behavioral|Low-Carbohydrate Diet|Participants will be instructed to follow a low-carbohydrate diet.
15855438|NCT03998878|Behavioral|Intermittent Energy Restriction|Participants will be instructed to follow intermittent energy restriction.
15855439|NCT03998878|Behavioral|Hunger Training|Participants will be instructed to follow Hunger Training.
15855440|NCT03998865|Device|Provisional abutment material|The effect of the provisional abutment material on the characteristics of the bacterial microbiota will be assessed by using PEEK (experimental) or Titanium (active comparator) provisional abutments.
15855441|NCT03998852|Drug|Positron Emission Tomography (PET) with [18F]-FDOPA|Positron Emission Tomography (PET) with [18F]-FDOPA
15855442|NCT03998852|Drug|Positron Emission Tomography (PET) with [18F]-FEOBV|Positron Emission Tomography (PET) with [18F]-FEOBV
15855443|NCT03998852|Device|Magnetic Resonnance Imaging (MRI)|MRI protocol will be performed on the same day that the [18F]-FEOBV PET imaging, using a 3T scanner (Philips Medical System). Different types of images will be acquired.
15855444|NCT03998852|Other|Neuropsychological evaluation|Neuropsychological evaluation will be performed, consisting in an assessment of apathy by actigraphy (social or physical activities will be recorded during seven days) and a complementary assessment of apathy using the Lille Apathy Rating Scale (LARS)
15855445|NCT03998839|Other|Community distribution of Sulfadoxine-pyrimethamine (SP)|Community health workers will distribute SP to pregnant women, targeting at least three times during pregnancy.
15855446|NCT03998826|Drug|Piroxicam|20mg piroxicam
15855447|NCT03998826|Drug|Placebo|placebo
15855448|NCT03998813|Drug|Ropivacaine|Locoregional analgesia by femoral triangle catheterization
15855449|NCT03998813|Drug|Ropivacaine|Tissue infiltration
15855450|NCT03998800|Dietary Supplement|Dietary Supplement|Dietary Supplement: L-arginine and L-citrulline supplement, L-arginine supplement, or placebo supplement (corn-starch) Subjects will complete 3 individual 10 day supplementation periods, separated by washout periods of approximately 2 weeks.
15855451|NCT03998800|Behavioral|Endurance exercise on a cycle ergometer|On day 10 of each supplementation period, subjects will complete a performance test on a cycle ergometer to investigate their endurance performance.
15855452|NCT03998787|Other|Neurophysiological assessment|Kinematic analysis of movement and transcranial magnetic stimulation
15855453|NCT03998774|Behavioral|Evaluate the anxiolytic effect during dental care with MEOPA in children|"Primary Purpose: The main objective of this study is to evaluate the anxiolytic effect of EMONO in children during dental care.
~Enrollment: 30"
15855454|NCT03998761|Drug|Micronized Progesterone|Progesterone will be started when endometrial thickness reached 8 mm or more. Patients will receive micronized progesterone (Cyclogest® 400mg; Actavis) at the dose of 400mg twice daily (morning and evening). A maximum of 2 embryos will be thawed on the day of embryo transfer, which is four days or six days after the start of progesterone depending on day-3 or day-5 embryo transfer. After thawing, surviving embryos will be transferred into the uterus under ultrasound guidance. Estradiol and progesterone will be continued until the day of pregnancy test. If the pregnancy test is positive, the patients will continue to use 800 mg micronized progesterone until 7 weeks of gestation.
15855455|NCT03998761|Drug|Micronized progesterone plus dydrogesterone|Progesterone will be started when endometrial thickness reached 8 mm or more. Patients will receive micronized progesterone (Cyclogest® 400mg; Actavis) at the dose of 400mg twice daily (morning and evening) plus dydrogesterone (Duphaston® 10mg, Abbott) at the dose of 10mg twice daily (morning and evening). A maximum of 2 embryos will be thawed on the day of embryo transfer, which is four days or six days after the start of progesterone depending on day-3 or day-5 embryo transfer. After thawing, surviving embryos will be transferred into the uterus under ultrasound guidance. Estradiol and progesterone will be continued until the day of pregnancy test. If the pregnancy test is positive, the patients will continue to use 800 mg micronized progesterone plus 20 mg dydrogestetrone until 7 weeks of gestation.
15855456|NCT03998748|Other|Sham Genetic Feedback|Participants will be told either that they have or do not have a genetic predisposition to developing depression.
15855458|NCT03998722|Device|Vagivital|Vagivital once Daily for 12 weeks
15855459|NCT03998709|Drug|Somatostatin|Somatostatin will be used to inhibit endogenous insulin secretion on either study day in both arms of the study
15855460|NCT03998709|Other|Dextrose|intravenous glucose will be used to raise fasting glucose in people with NFG / NGT
15855461|NCT03998709|Drug|Insulin|insulin will be used to lower fasting FFA and glucose in people with IFG / IGT
15855462|NCT03998709|Other|Intralipid|intravenous intralipid (Fat Emulsion) will be used to raise fasting FFA in people with NFG / NGT
15855463|NCT03998696|Drug|Cisplatin 40 mg/m2|Cisplatin 40 mg/m2, weekly, concurrent with Radiotherapy
15855464|NCT03998696|Drug|Cisplatin 100 mg/m2|Cisplatin 100 mg/m2, three weekly, concurrent with Radiotherapy
15855465|NCT03998683|Drug|Guselkumab 100 mg|Guselkumab 100 mg will be administered as SC injection.
15855466|NCT03998683|Drug|Placebo|Placebo will be administered as SC injection.
15855467|NCT03998670|Device|Prism Glasses|Spectacles with refractive correction and base-in relieving prism (40% of the greater of the exodeviation by PACT at distance or near) equally divided between the 2 lenses
15855468|NCT03998670|Device|Non-Prism Glasses|Spectacles with refractive correction (or plano spectacles if no significant refractive error) and no prism
15855469|NCT03998657|Device|Exablate Prostate Treatment|The Exablate system is a non-invasive thermal ablation device that is being used to ablate tissue. The system combines a focused ultrasound surgery (FUS) delivery system and MRI scanner.
15855470|NCT03998631|Procedure|Carbon Dioxide and Saline Flush|The TEVAR or TAVI device will be flushed with approximately 1.2L of medical grade carbon dioxide using a 60mL syringe and connecting tubing. The reservoir will then be flushed with at least 60mL of standard saline prior to deployment to minimize bubbles in the saline.
15855471|NCT03998631|Procedure|Standard Saline Flush|Standard of care flushing of the TEVAR or TAVI device with normal saline.
15855472|NCT03998618|Behavioral|Acceptance and Commitment Therapy|Across six weekly 50-minute sessions, patients in the Acceptance and Commitment Therapy condition will practice various mindfulness exercises, clarify their values, and set specific goals consistent with their values. Sessions will incorporate discussion of patients' cancer experiences. Through in-session and home practice of skills, participants will learn new and more adaptive ways to respond to fatigue. Participants will receive handouts on session topics and a CD that we developed to guide mindfulness practices.
15855473|NCT03998618|Behavioral|Education/Support|Across six weekly 50-minute sessions, patients in the education/support condition will discuss their concerns, including symptoms and other cancer-related stressors, with a therapist providing psychological support. The therapist will direct patients to resources for practical and health information and contact information for psychosocial services. Sessions will include an orientation to the patient's medical center, education regarding common cancer-related symptoms and quality-of-life concerns, and an overview of resources for addressing these concerns. The therapist will also describe resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants will receive handouts on session topics and will be asked to review them as homework.
15855474|NCT03998605|Behavioral|Abuse Prevention Program|The abuse prevention program will be comprised of nine shared learning modules for the individual with Intellectual Disabilities (ID) and a care provider. Each shared module will contain an action step in the Individual Response Plan and will include video, guided practice and workbook activities to equip persons with ID with a range of judgment, decision-making skills and the efficacy needed for identifying, rejecting, and reporting abuse.
15855475|NCT03998605|Behavioral|Control Condition|The control group will receive worksheets from the ESCAPE-NOW curriculum.
15855476|NCT03998592|Biological|Streptococcus pyogenes vaccine (50 µg)|Vaccine containing 50 µg of StreptInCor synthetic peptide and Aluminium Hydroxide as adjuvant
15855477|NCT03998592|Biological|Streptococcus pyogenes vaccine (100 µg)|Vaccine containing 100 µg of StreptInCor synthetic peptide and Aluminium Hydroxide as adjuvant
15855478|NCT03998592|Biological|Streptococcus pyogenes vaccine (200 µg)|Vaccine containing 200 µg of StreptInCor synthetic peptide and Aluminium Hydroxide as adjuvant
15855479|NCT03998592|Other|Placebo|Placebo without active component
15855480|NCT03998579|Other|The CanMoRe programme|An exercise intervention in Primary Health Care
15855481|NCT03998579|Other|Home exercise|An active control group
15855482|NCT03998566|Device|TraceIT Tissue Spacer implantation|The TraceIT Tissue Spacer will be implanted between duodenum and pancreas using endoscopic procedure. After implantation patient will have radiotherapy treatment per standard of care.
15855521|NCT03998254|Drug|V503|9vHPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine
15855522|NCT03998254|Drug|Gardasil|qHPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine
15855483|NCT03998553|Procedure|IN VITRO MATURATION AND OOCYTE ACTIVATION|This study aims to fine-tune the in vitro maturation (IVM) technique to achieve nuclear mature oocytes, i.e., to mature the oocytes up to the metaphase II stage. In addition, an artificial oocyte activation (AOA) will be carried out to check the cytoplasmic maturation of the oocytes, avoiding the generation of potentially viable embryos.
15855484|NCT03998540|Diagnostic Test|Western blot|Western-blot analysis of a giant protein, with specific antibodies directed against C-ter and N-Ter of the protein
15855485|NCT03998540|Other|Protein interaction studies|Analyses of several interacting proteins by specific Western-blot and in-vitro tests.
15855486|NCT03998527|Device|Transcutaneous Electrical Spinal Cord Stimulation (TcESCS)|TcESCS is a non-invasive DC battery powered device. Investigators and/or research team members will continually assess the appropriate stimulation parameters including configurations, current, voltage and frequency delivered by up to five active electrodes applied on skin of the back from cervical to lumbar levels. Stimulation parameters used during experimental assessments and interventions will be closely monitored by the research team. Every research participant will be slowly acclimated to stimulation. Blood pressure, heart rate, respiratory rate, and electromyography will be closely monitored while we are determining the correct stimulation parameters in the lab. During the stimulation training sessions, we will monitor blood pressure regularly throughout the session.
15855487|NCT03998514|Drug|CB4211 Dose 1|Administered by subcutaneous injection
15855488|NCT03998514|Drug|CB4211 Dose 2|Administered by subcutaneous injection
15855489|NCT03998514|Drug|CB4211 Dose 3|Administered by subcutaneous injection
15855490|NCT03998514|Drug|CB4211 Dose 4|Administered by subcutaneous injection
15855491|NCT03998514|Drug|CB4211 Dose 5|Administered by subcutaneous injection
15855492|NCT03998514|Drug|CB4211 Dose 6|Administered by subcutaneous injection
15855493|NCT03998514|Drug|CB4211 Dose TBD|Administered by subcutaneous injection
15855494|NCT03998514|Drug|Placebo|Administered by subcutaneous injection
15855495|NCT03998501|Behavioral|Cognitive Behavioral Therapy with Mindfulness Class|The CBTm classes are five, 90-minute sessions focused on strategies to reduce symptoms of anxiety and depression.
15855496|NCT03998488|Drug|Fecal Microbiota Transplantation|"The proposed intervention will deliver 250 milliliters of FMT by colonoscopy to the investigational FMT treatment groups at week 0. The placebo treatment group will instead receive the placebo FMT by colonoscopy at week 0 and then the investigational FMT by flexible sigmoidoscopy at week 8.
~Investigational FMT is biologically active human fecal material that is pre-screened, tested, quarantined, stored, packaged, and labeled by OpenBiome. Placebo FMP250 is a control unit made of glycerol, saline, and food dye that is stored, packaged, and labeled identically to the investigational FMT, to ensure blinding during delivery."
15855497|NCT03998488|Dietary Supplement|Psyllium Husk Powder|"All subjects assigned to the fiber treatment arms will be required to take 1 teaspoon (approximately 5 grams) of psyllium husk powder twice a day (morning and night) for 8 weeks, beginning 3 days prior to Week 0 screening colonoscopy.
~Psyllium husk powder is the dried and powdered form of a psyllium seed coat."
15855498|NCT03998475|Behavioral|Transition preparation intervention|Young adult participants and parents will complete transition preparation sessions that include meeting with a health behavior coach for in-person sessions and review of materials sent electronically between study visits.
15855499|NCT03998462|Behavioral|Mindfulness Based Stress Reduction|MBSR consists of 6-10 individuals with PD and led by a trained instructor who is not involved in the clinical care or assessment of these participants.
15855500|NCT03998462|Radiation|Creative Education Care|Creative Education Care consists of 6-10 individuals with PD and led by a trained instructor who is not involved in the clinical care or assessment of these participants.
15855501|NCT03998449|Biological|Vaccination against cholera|Participants will receive two doses of an oral cholera vaccine with an interval of 2-4 weeks.
15855502|NCT03998436|Drug|Esmolol Hydrochloride|Galnobax-14% gel application along with Standard of Care
15855503|NCT03998436|Other|Only Standard of Care|Only Standard of Care treatment
15855504|NCT03998436|Other|Vehicle Gel|Vehicle gel application along with Standard of Care
15855505|NCT03998423|Biological|Fecal Microbiota Transplant|Double-encapsulated Fecal Microbiota Transplant Capsules
15855506|NCT03998410|Device|Lung Doppler Signals|Recording Doppler ultrasound on the right chest wall
15855507|NCT03998397|Biological|blood alcohol concentration withdrawal|The blood alcohol concentration is systematically performed in all intoxicated patients admitted in Emergency Department
15855508|NCT03998384|Procedure|retrobulbar injection of autoserum|Retrobulbar block is usually a type of regional anesthetic nerve block used in intraocular surgery. In this technique, local autoserum is injected into the retrobulbar space for the neurotrophic purpose.
15855509|NCT03998384|Procedure|retrobulbar injection of placebo|Retrobulbar block is usually a type of regional anesthetic nerve block used in intraocular surgery. In this technique, normal saline (NS) is injected into the retrobulbar space as a comparison
15855510|NCT03998371|Diagnostic Test|Low-coverage whole-genome sequencing of urine exfoliated cells|The level of CIN The extracted DNA from morning urine will be analyzed by UCAD to determine the level of CIN.
15855511|NCT03998345|Drug|609A|609A is a recombinant anti-PD-1 humanized IgG4 kappa antibody that targets the human PD-1
15855515|NCT03998306|Dietary Supplement|Experimental: Probiotics|"the participants will receive probiotic lozenge before falling asleep for 12 weeks.
~the participants will receive dietetic and hygienic instructions"
15855516|NCT03998306|Other|No intervention|No intervention
15855517|NCT03998293|Drug|Somatostatin|infused to block endogenous insulin secretion over a 4 hour period
15855518|NCT03998280|Device|Assessment|Neck proprioception and postural stability
15855519|NCT03998267|Device|Droobi|A new mobile application, specifically built for the diabetes patients in Qatar with the help of local expertise.
15855520|NCT03998267|Other|Standard of care|Standard of care including physicians, dietetics and diabetes educators support
15855524|NCT03998228|Diagnostic Test|Dual X-ray absorptiometry (DMO) densitometry.|"Simple clinical examination with forearm inspection and palpation;
~Radiological examination of BMD;
~Calculation of the FRAX® score;
~Fact sheet on patients with dermatoporosis, proposal of a topical treatment (cosmetic cream) and completion of the questionnaire specific to dermatoporosis"
15855525|NCT03998215|Biological|Diphtheria booster vaccination|Participants received intramuscularly in the deltoid muscle one dose of the trivalent vaccine against diphtheria, tetanus and acellular pertussis
15855526|NCT03998189|Other|Breath Collection|Pre-surgery, two 500 ml of exhaled breath volatiles (EBV) in each of 4 collection tubes will be collected in 5-7 min of breathing
15855527|NCT03998189|Other|Saliva Collection|Pre-surgery, 2 ml minimum of saliva will be collected into SalivaBio Passive Drool collection tubes
15855528|NCT03998189|Other|Blood Collection|Pre-surgery, an optional 5 ml blood sample in each redtop and purple top vacutainer blood collection tube
15855529|NCT03998189|Other|Urine Collection|Pre-surgery, 25 ml minimum of urine will be collected in sterile specimen containers
15855530|NCT03998189|Other|Tumor Collection|During surgical tumor removal, a tumor tissue sample will be collected
15855531|NCT03998189|Other|Medical History Data Collection|Medical history will be obtained from the patients charts to identify demographics (age, race, ethnicity, zip code), oncologic history (date of diagnosis and cancer type), and medical history of disease.
15855532|NCT03998176|Drug|Bictegravir/emtricitabine/tenofovir alafenamide|B/F/TAF single tablet formulation
15855533|NCT03998163|Drug|CR845 0.5 mcg/kg|IV CR845 0.5 mcg/kg administered three times/week
15855534|NCT03998150|Procedure|Holmium laser enucleation of the prostate|cystoscopic transurethral enucleation of the prostate using Holmium laser (Asclepion MultiPulse HoPlus 110W and Lumenis pulse 100W and 120W)
15855535|NCT03998150|Procedure|Bipolar plasma kinetic enucleation of the prostate|cystoscopic transurethral enucleation of the prostate using bipolar plasma kinetic energy (KLS Martin Maxium or Covidien Force Triad)
15855536|NCT03998137|Device|AUGMENT® Injectable Bone Graft|AUGMENT® Injectable Bone Graft
15855537|NCT03998137|Procedure|Standard of Care|Autologous Bone Graft
15855538|NCT03998124|Behavioral|Peer facilitator training|Peer facilitation of a project-based activity without staff present
15855539|NCT03998124|Other|Usual care|Staff-led social activity
15855540|NCT03998111|Diagnostic Test|Oral glucose tolerance test|Participants will ingest 75 g anhydrous glucose dissolved in water and the blood responses will be measured over the following 2-hours using a venous cannula.
15855541|NCT03998098|Diagnostic Test|Oxygen Saturation (Oximetry)|"Participants enter a chamber with a modifiable atmosphere and sit on a bench associated with an exercise bicycle. The subject breathes hypoxic air to achieve various SpO2 readings throughout the range of 80-97%.
~The participants undertake recumbent cycling for up to 10 minutes at various intervals and differing oxygen/nitrogen balances to induce changes in their vital signs.
~Measurements of the Vital Signs are taken at various time points using Lifelight First and the reference device using 2 observers"
15855542|NCT03998098|Diagnostic Test|Heart Rate (Pulse)|"Participants enter a chamber with a modifiable atmosphere and sit on a bench associated with an exercise bicycle. The subject breathes hypoxic air to achieve various SpO2 readings throughout the range of 80-97%.
~The participants undertake recumbent cycling for up to 10 minutes at various intervals and differing oxygen/nitrogen balances to induce changes in their vital signs.
~Measurements of the Vital Signs are taken at various time points using Lifelight First and the reference device using 2 observers"
15855543|NCT03998098|Diagnostic Test|Respiratory Rate|"Participants enter a chamber with a modifiable atmosphere and sit on a bench associated with an exercise bicycle. The subject breathes hypoxic air to achieve various SpO2 readings throughout the range of 80-97%.
~The participants undertake recumbent cycling for up to 10 minutes at various intervals and differing oxygen/nitrogen balances to induce changes in their vital signs.
~Measurements of the Vital Signs are taken at various time points using Lifelight First and the reference device using 2 observers"
15855544|NCT03998098|Diagnostic Test|Blood Pressure|"Participants enter a chamber with a modifiable atmosphere and sit on a bench associated with an exercise bicycle. The subject breathes hypoxic air to achieve various SpO2 readings throughout the range of 80-97%.
~The participants undertake recumbent cycling for up to 10 minutes at various intervals and differing oxygen/nitrogen balances to induce changes in their vital signs.
~Measurements of the Vital Signs are taken at various time points using Lifelight First and the reference device using 2 observers For participants only participating in the Blood Pressure Arm of the trial, they will not be required to enter the normobaric chamber but will have their blood pressure readings taken in the ambient environment including lying supine in order to generate hypotensive readings."
15855545|NCT03998085|Drug|Anlotinib Hydrochloride|Anlotinib hydrochloride capsule 12 mg, orally, once a day, oral before breakfast, according to the research program for 2 weeks, discontinued for 1 week. Patients with complete remission (CR), partial remission (PR) and stable disease (SD) continued to administer drugs until the disease progressed, intolerable toxicity or withdrawal was required. Patients with progression of illness (PD) discontinued their medication.
15855546|NCT03998072|Other|Five session cognitive analytic therapy (CAT) consultancy|Five session consultancy with patients and care coordinators using cognitive analytic therapy
15855547|NCT03998059|Procedure|splenectomy|These patients should fail to have sustained response to multiple first- and second-line treatments of ITP and agree to have splenectomy.Before splenectomy, these patients will be reassessed and still diagnosed with ITP.Their platelet level will be raised to a safe state before surgery, and the laparoscopic splenectomy will be performed in Tianjin People's Hospital.
15855548|NCT03998046|Behavioral|Outreach Support for Weight Loss Goal Setting and Self-Weighing|Patients will receive a MyChart activation message assessing weight loss interest that invites them to complete a MyChart Survey encouraging a weight loss goal using principles adapted from Brief Action Planning. Patients will then receive a cellular network-enabled electronic body weight scale, and weighing data transmitted by the scale will be received and integrated into the electronic health record for access by the patient's primary care team.
15855549|NCT03998046|Behavioral|Outreach Decision Support to Encourage Linkages to Intensive Community Lifestyle Interventions|"Patients will receive via MyChart information and decision support designed to encourage linkages to and participation in intensive lifestyle programs available in the community. Patients who request information or clinical referrals will also receive them. Refreshes of community linkage information will be sent by MyChart every 1 to 4 weeks."
15855550|NCT03998046|Behavioral|Adaptive Tailoring of Information Delivery and Intensity of Primary Care Outreach Support|Data received into the electronic health record from the cellular network-enabled electronic scale will categorize each patient based on their daily self-weighing behaviors and rate of progress towards their weight loss goal. Patients who are not engaged in daily self-weighing or are not making progress towards their goal will receive more intensive outreach support in the form of automated weekly MyChart problem solving messages, more frequent encouragement to access a broader array of community resources, and telephonic support from a nurse care coordinator who is an existing member of the primary care team. Support from this nurse care coordinator will be facilitated by the incorporation of each patient's self-weighing data into an EpicCare patient dashboard accessible to the nurse coordinator and other members of the care team
15855551|NCT03998033|Biological|ET140202 autologous T cell product|Autologous T cells transduced with lentivirus encoding an ET140202 expression construct
15855552|NCT03998020|Other|scale of severity|assessment of the severity of the sleep disorders by scale
15855553|NCT03998020|Genetic|blood sample|Genetical study, serum and sample
15855554|NCT03998007|Device|IRIS System|A QEEG based pain biomarker that scales with the patient reported NRS
15855555|NCT03997994|Device|GIE Drug Coated Balloon|The GIE DCB is a balloon catheter coated with a proprietary coating containing the drug and carriers.
15855556|NCT03997968|Drug|CYT-0851|Montherapy patients will receive CYT-0851 as a single agent
15855557|NCT03997968|Drug|CYT-0851|Combination arm patients will receive CYT-0851 in combination with chemotherapy
15855558|NCT03997968|Drug|CYT-0851|Combination arm patients will receive CYT-0851 in combination with anti-CD20 antibody and chemotherapy
15855559|NCT03997955|Other|Myofascial induction|Myofascial induction in plantar fascia
15855560|NCT03997955|Other|Sham myofascial induction|Sham myofascial induction in plantar fascia
15855561|NCT03997942|Other|Effect of exercise|Once the data are available, we hope to have information about which of the exercise practices included in the rehabilitation program of acute upper extremity burn patients is more effective.
15855562|NCT03997929|Diagnostic Test|1.3 BETA D GLUCAN|dosage of 1.3 BETA D GLUCAN in the peritoneal fluid obtained during surgery with the FUNGITELL test (Associate of CAPE COD)
15855563|NCT03997916|Device|Belun Ring|All patients scheduled for attended overnight in-lab polysomnography (PSG) in our 2 sleep labs will undergo PSG testing. On the same night of the PSG testing, these same patients will also wear the Belun Ring device. After the study, we will compare results of the Belun Ring device vis-à-vis with the results of the PSG on the same patient.
15855564|NCT03997916|Diagnostic Test|PSG|All patients scheduled for attended overnight in-lab polysomnography (PSG) in our 2 sleep labs will undergo PSG testing. On the same night of the PSG testing, these same patients will also wear the Belun Ring device. After the study, we will compare results of the Belun Ring device vis-à-vis with the results of the PSG on the same patient.
15855565|NCT03997903|Drug|Imatinib Mesylate|"The starting dose for subjects will be 340 mg/m2/day with a maximum dose of 600 mg daily.
~Patients will receive Imatinib orally once daily for 6 months."
15855566|NCT03997890|Procedure|Cataract surgery with binocular implantation of either Symfony (ZXR00) or Symfony toric (ZXT) IOLs|After creating an initial side port incision with a 15-degree blade, 3-step clear corneal incisions were made using a 2.5 mm disposable metal blade. Sodium hyaluronate 1.0% (Healon; Abbott Medical Optics) was then injected into the anterior chamber. A continuous curvilinear capsulorrhexis, measuring 5.5 mm in diameter, was generated using a 26 gauge bent needle. After hydrodissection, phacoemulsification was done to remove nuclear fragments and aspiration of residual cortex. In all eyes, a Symfony or Symfony toric IOL was implanted in the capsular bag using a disposable implantation system. Irrigation and aspiration were performed to minimize ophthalmic viscoelastic surgical device retention at the end of surgery. The main incision and side port were sealed with stromal hydration using a balanced salt solution.
15855567|NCT03997877|Other|Physical activity|Increase physical activity Balanced diet
15855568|NCT03997864|Drug|Prazosin|"Starting dose: 2mg at HS. Maximum dose: 15 mg at HS. Dosage will be increased 1 mg every 3 days until sleep is improved, max dose is reached, or side effects are problematic.
~Tapering Decrease prazosin 1 mg every 3 days or 3 mgs per week until off completely. Tapering will take approximately 2-3 weeks."
15855569|NCT03997864|Drug|Placebos|Starting dose: 2mg at HS. Maximum dose: 15 mg at HS. Dosage will be increased 1 mg every 3 days until sleep is improved max dose is reached, or side effects are problematic.
15855570|NCT03997851|Drug|Acetaminophen|Topical acetaminophen gel
15855571|NCT03997851|Drug|Carbomer 980|Topical vehicle gel
15855572|NCT03997838|Drug|VVZ-149 Injections|IV infusion of 1000 mg of VVZ-149
15855573|NCT03997838|Drug|Placebo|IV infusion of 0 mg of VVZ-149
15855574|NCT03997825|Device|Basivertebral Nerve (BVN) Ablation|Single follow-up visit of previously treated participants from the SMART trial.
15855575|NCT03997812|Drug|VVZ-149 Injections|IV infusion of 1000 mg of VVZ-149
15855576|NCT03997812|Drug|Placebo|IV infusion of 0 mg of VVZ-149
15855577|NCT03997799|Procedure|uniportal lobectomy with complete lymphadenectomy|uniportal lobectomy with complete lymphadenectomy
15855578|NCT03997786|Drug|Tildrakizumab|"Part A: Pediatric subjects with a body weight in the highest category will be treated with the same dose as adult subjects (e.g. 100 mg for patients weighing >40 kg). Lower doses will be selected with the aim to achieve tildrakizumab plasma exposures in the clinically relevant range across all body weight(BW) categories (e.g. subjects weighing 15 -40 kg, will be given 2.5 mg/kg BW).
~Part B: Subcutaneous injection of tildrakizumab will be administered at Weeks 0 and 4"
15855579|NCT03997786|Drug|Placebo - tildrakizumab|Subcutaneous injection of placebo will be administered at Weeks 0 and 4
15855580|NCT03997786|Drug|Etanercept|Etanercept will be administered at 0.8mg/kg (for subjects <63kg) and 50 mg (for subjects weighing >63kg body weight) weekly for 12 weeks
15855581|NCT03997773|Behavioral|Face-it Intervention|The Face-it intervention is a health promotion intervention consisting of 3 major components: 1) active involvement of health visitors, 2) digital health technology and coaching, and 3) a structured cross-sectoral communication system in the healthcare system. The intervention will begin at time approx. 3 months (after the baseline data collection, i.e. 10-14 weeks postpartum), and continues until 12 months
15855582|NCT03997760|Drug|SHP655|Participants will receive SHP655 as a single IV infusion at one of the 3 dose levels of 40 IU/kg, 80 IU/kg, or 160 IU/kg.
15855583|NCT03997760|Other|Placebo|Participants will receive placebo matched to SHP655 of the 3 dose levels of 40 IU/kg, 80 IU/kg, and 160 IU/kg as single IV infusion.
15855584|NCT03997747|Other|cytology specimen|Biopsy and Genetic: DNA analysis;Genetic: RNA analysis;Genetic: microarray analysis; Genetic: mutation analysis; Genetic: polymorphism analysis
15855585|NCT03997734|Drug|AB001|single and repeated dosing
15855586|NCT03997734|Drug|oral capsule|single dose
15855587|NCT03997734|Drug|positive comparative patch|single and repeated dosing
15855588|NCT03997734|Drug|Placebos|single and repeated dosing
15855591|NCT03997695|Other|Core stabilization exercise group|The CSE program was carried out 2 days a week for 6 weeks (12 sessions) by supervisor physiotherapist. The CSE program aimed to perform neutral spine and activation of core muscles. Prior to the CSE program, participants were informed about core musculature and their function.The 6-weeks CSE program was performed in stages with gradual progression according to the stages of motor learning and sensory motor integration as static, dynamic, and functional.
15855592|NCT03997695|Other|Core stabilization exercise plus kinesio taping group|The CSE program was carried out 2 days a week for 6 weeks (12 sessions) by supervisor physiotherapist. The CSE program aimed to perform neutral spine and activation of core muscles. Prior to the CSE program, participants were informed about core musculature and their function.The 6-weeks CSE program was performed in stages with gradual progression according to the stages of motor learning and sensory motor integration as static, dynamic, and functional.
15855593|NCT03997682|Other|Hands-Up Program|In addition to the usual care, being allocated to the intervention group would require the participant to attend an exercise and education program once their cast has been removed and they've restored some strength and function in their hand and wrist. The exercise portion of the intervention will focus on strength and balance training, with aspects of managing our distal radius fracture healing as well. The education will focus on learning about risk factors for a distal radius fracture, osteoporosis, exercise for adults, nutrition for adults and falls prevention strategies.
15855594|NCT03997669|Other|Collection of pleural effusion|Detection of pleural effusion
15855595|NCT03997656|Behavioral|MyDiPP (Malaysia Diabetes Prevention Program)|The participants will go through 16-weekly core lessons that need to be completed within the first 24 weeks after randomisation focusing on changing dietary habits, increase physical activity and relapse prevention and 6-monthly post-core lessons focusing on maintenance of lifestyle habits and weight loss achieved during the core program.
15855596|NCT03997656|Other|usual care|standard health education from primary care providers in the clinic
15855597|NCT03997643|Radiation|Radiotherapy to all dissected areas|Post operative radiation therapy +/- chemotherapy based on historic treatment volumes (including the primary site, dissected areas +/- elective areas
15855598|NCT03997643|Radiation|Omit radiation to pN0 neck|post operation radiation therapy +/- chemotherapy that avoids targeting the dissected pN0 neck
15855599|NCT03997630|Device|High flow Oxygenation|Interventional group: All patients included in this group will receive a continuous heated and humidified high-flow (30 to 60 l/min) oxygenation with a nasal cannula for 48 hours. Initially, flow rate will be started at 50 l/min with a FiO2 at 50%. According to the protocol, flow rate and FiO2 will be titrated on SpO2 and respiratory tolerance. Weaning and failure of high-flow oxygenation are described in detail in the study protocol.
15855600|NCT03997630|Device|Standard oxygen|Control group: All patients included in this group will receive a low flow oxygenation (flow rate < 15 l/min) with nasal cannula (flow rate ≤ 6 l/min) or non-rebreathing mask (flow rate ≥ 7 l/min).
15855601|NCT03997617|Diagnostic Test|Personalized Functional Profiling|During this pilot study, the overall goal of the project is to establish an effective workflow between the patient, the PFP platform, the clinician and return to the patient. This includes collection of the biopsy or surgery piece and standardized processing, dissociation, drug profiling and issuing treatment recommendation to the clinician. In case the clinician follows this treatment recommendation, patient management and follow up will be performed according to standard of care.
15855602|NCT03997604|Device|Full Dentures created by additive manufacturing|Full dentures created by Additive manufacturing (Carbon Printers)
15855603|NCT03997591|Other|Ready2E.A.T. PROGRAM|"Training tasks based on:
~reaching activities during attention tasks, memory tasks, sequential tasks This group was assessed at T0 and then after 6 weeks of conventional therapy."
15855604|NCT03997578|Procedure|NIPSA (Non-incised papilla surgical approach)|To access the defect, a single horizontal or oblique apical incision will be made in the mucosa located on the bony cortex, far from the marginal tissues and apically to the edge of the bony crest delimiting the defect. The incision will be extended mesiodistally as necessary to allow access to the defect and correct debridement of the granulation tissue. The tissue coronal to the incision will be raised full thickness, trying to maintain the preoperative papillae architecture intact. The granulation tissue and epithelium of the pocket will be eliminated. The affected root will be scaled and planed, and calculus eliminated. Once the defect will be debrided, the regenerative biomaterials will be applied. Then the incision line will be sutured by a double suture line to facilitate closing without tension: The first with internal horizontal mattress sutures to approximate the connective tissue of both edges of the mucosal incision, and the second with single interrupted sutures.
15855605|NCT03997578|Procedure|NIPSA plus connective tissue graft|In these patients, the following methodology will be added to the technique described for the NIPSA group: once the biomaterials are applied, a connective tissue graft, taken at the level of the first upper molar, will be sutured to the base of the soft supra-alveolar tissue and to the palatal tissue, which has not been disinserted, using simple sutures.
15855769|NCT03996278|Other|Grafalon|None interventional study but there are two groups
15863126|NCT03937206|Dietary Supplement|NutriterraTM|Nutriterra 1000mg
15855606|NCT03997565|Procedure|TKR|No intervention provided, but investigation of the ability to modulate motor performance during specific and functional tasks in subjects undergoing TKR compared with healthy subjects.
15855607|NCT03997552|Procedure|Non-incised papillae surgical approach (NIPSA)|Periodontal reconstructive surgery
15855608|NCT03997552|Procedure|marginal approach by palatal incision|Periodontal reconstructive surgery
15855609|NCT03997552|Procedure|Minimally invasive surgical technique (MIST)|Periodontal reconstructive surgery
15855610|NCT03997539|Drug|Pyrotinib|Pyrotinib Maleate combine with vinorelbine as the second-line treatment to HER2-positive Metastatic Breast Cancer
15855611|NCT03997539|Drug|Treatment of physician's choice|The treatment of physician's choice (TPC) was a protocol-specified approved or standard of care therapy or combination of therapies, based on frequently used regimens for second-line HER2-positive metastatic breast cancer treatment after receipt of trastuzumab-containing regimens. The therapies included single-agent chemotherapy, single-agent (e.g., tamoxifen or aromatase inhibitor) or dual-agent (e.g., aromatase inhibitor with luteinizing hormone releasing hormone [LHRH] agonist) hormonal therapy for hormone receptor positive-disease, and single-agent HER2-directed therapy.
15855612|NCT03997539|Drug|vinorelbine|vinorelbine
15855613|NCT03997526|Device|3C Patch|A platelet-rich plasma gel patch comprised of distinct fibrin, platelet, and leukocyte substantially parallel layers, prepared without the use of any added reagents through a two-step centrifugation process
15855614|NCT03997513|Behavioral|Pulmonary Telerehabilitation|The intervention will consist of an eight-week, three sessions per week, home-based pulmonary telerehabilitation program that will incorporate both lower extremity endurance exercise and upper and lower extremity resistance training. Subjects randomized to the study intervention will also participate in a one hour, twice-monthly support group via group video conferencing consisting of an educational topic (i.e. inhaler use, understanding COPD) and group discussion.
15855615|NCT03997500|Drug|normal saline|a bolus of normal saline was given followed by normal saline infusion
15855616|NCT03997500|Drug|Norepinephrine|a bolus of norepinephrine was given followed by norepinephrine infusion
15855617|NCT03997487|Other|TOFTEE|Smartphone app for taking quality images of conjunctivae
15855618|NCT03997474|Biological|ATL001|ATL001 infusion
15855619|NCT03997474|Drug|Checkpoint Inhibitor|Nivolumab
15855620|NCT03997461|Device|BPro|BPro and Oscar 2 comparison for 24 hours
15855621|NCT03997448|Drug|Pembrolizumab|Pembrolizumab 200mg IV
15855622|NCT03997448|Drug|Abemaciclib|Abemiciclib 150mg PO
15855625|NCT03997422|Procedure|Vertical Sleeve Gastrectomy (VSG)|Vertical Sleeve gastrectomy will be performed using five laparoscopic ports using a 40 French Bougie as a template. If a hiatal hernia is identified it will be repaired. This practice has greatly reduced postoperative reflux disease (see human subjects protection). As VSG for patients with a BMI 30.0-34.9 kg/m2 is not covered by insurance the University hospital will cover costs for up to 24 patients.
15855629|NCT03997370|Procedure|Biospecimen Collection|Undergo collection of blood samples
15855630|NCT03997370|Drug|Carboplatin|Given IV
15855631|NCT03997370|Drug|Iohexol|Given IV
15855632|NCT03997344|Behavioral|Group nature hikes|Six group nature hikes will be offered once every other week. Total duration of intervention is 12 weeks. Hikes will be co-lead by two experienced hike leaders.
15855633|NCT03997344|Behavioral|Group urban hikes|Six group urban hikes will be offered once every other week. Total duration of intervention is 12 weeks. Hikes will be co-lead by two experienced hike leaders.
15855634|NCT03997331|Other|CRx Health|CRx Health is a connected health solution comprised of connected devices (InsulCheck, a Bluetooth-enabled pill bottle cap, and a Bluetooth-enabled glucometer) paired to a mobile smartphone app (CRx Health).
15855635|NCT03997331|Other|Chronicare|Chronicare is a disease management program comprising self-management data from the CRx Health solution syncing to an automated support system (Intervention Engine) and a remote care application (CRx Care) used by a team of clinicians to remotely monitor and support patients.
15855636|NCT03997318|Biological|AMDC-USR|Autologous Muscle Derived Cells for Urinary Sphincter Repair
15855637|NCT03997318|Other|Placebo|Placebo control is the vehicle solution used for the study product.
15855638|NCT03997305|Device|AltaValve|Transcatheter Mitral Valve Replacement
15855639|NCT03997292|Drug|Alteplase|According to 0.6-0.9mg / kg alteplase (maximum can not exceed 90mg), of which 10% intravenous injection, the remaining 60 minutes intravenous infusion.
15855640|NCT03997292|Drug|Urokinase|1.2-1.5 million U dissolved in 100ml sodium chloride injection, 30 minutes intravenously.
15855641|NCT03997279|Drug|Saccharomyces boulardii|Rabeprazole 20 mg 2x1, for 14 days, followed by 1x1 for 14 days, Amoxicillin 1000 mg 2x1, for 14 days, Clarithromycin 500 mg 2x1, for 14 days, Metronidazole 500 mg 2x1, for 14 days, Saccharomyces boulardi 500 mg 1x1, for 3 week
15855642|NCT03997279|Drug|Placebo|Rabeprazole 20 mg 2x1, for 14 days, followed by 1x1 for 14 days, Amoxicillin 1000 mg 2x1, for 14 days, Clarithromycin 500 mg 2x1, for 14 days, Metronidazole 500 mg 2x1, for 14 days, Placebo 1x1, for 3 week
15855643|NCT03997266|Drug|Ampicillin|Intravenous ampicillin
15855644|NCT03997266|Drug|Gentamycin|Intravenous gentamycin
15855645|NCT03997266|Drug|Normal saline|Intravenous normal saline
15855646|NCT03997253|Other|blood and urine samples|various blood and urine samples will be collected from the recipient at D0, D7, D14, M1, M3, M6 and M12.
15855728|NCT03996616|Device|Impedance Threshold Device|An an impedance threshold device ITD-16 (ResQPOD-16, Zoll, USA) will be placed on the patient's airway before the head is elevated.
15855770|NCT03996265|Drug|Bupropion Hydrochloride Controlled-release|Given PO
15855771|NCT03996265|Other|Placebo|Given PO
15855648|NCT03997227|Procedure|Erector spinae Block|After anesthesia and surgical procedures, a bilateral ESP block with ultrasound guidance will be applied from the T10 level at the middle line 3 cm lateral. Prior to the block, with povidone iodine, the T10 transverse protrusion will be determined by using linear ultrasound probe. The local anesthetic will be applied between the transverse projection and the erector spina muscle with the help of an isolated needle designed for peripheral block operations. Without local anesthesia, the location of the needle with saline will be confirmed by hydrodissection. After confirming the location of the needle, 20 ml of LA and saline mixture will be applied and the same procedure will be repeated in the control. A total of 40 ml of LA, 20 ml of bupivacaine 0.5%, 10 ml of lidocaine 2%, 10 ml of saline will be composed of saline.
15855649|NCT03997214|Device|inspiratory muscle strength training|The experimental group received the intervention of inspiratory muscles training 5times/week for 6 weeks, 5days/ per cycle; the patients stayed in the semi-recumbent position, recorded the initial/first measurement of MIP. The trigger sensitivity was adjusted to 10% of the first recorded MIP at the start of training, then reducing the ventilator trigger sensitivity and training duration weekly.
15855650|NCT03997201|Procedure|Ripple Mapping guided ischaemic VT ablation|"Endocardial mapping of the ventricle performed with Ripple Mapping (CARTO3v6, Biosense Webster Inc). Ablation (SmarTouch Thermocool Catheter, Biosense Webster Inc) delivered to areas of abnormal late electrical activity within ventricular scar tissue."
15855651|NCT03997188|Device|Hepilor|ZLC oral suspension and placebo were both started on Day 1 of RT-HeT and ended when RT was completed or at the onset of dysphagia.
15855652|NCT03997175|Other|Biodiversity powder|Biodiversity sand contained biodiversity powder that contains a highly diverse and rich microbial community but no known pathogens.
15855653|NCT03997175|Other|Placebo|Sand that looks like intervention sand but does not have high biodiversity
15855654|NCT03997162|Other|Best Practice|Complete standard of care enhanced recovery after surgery protocol
15855655|NCT03997162|Other|Quality-of-Life Assessment|Ancillary studies
15855656|NCT03997162|Other|Questionnaire Administration|Ancillary studies
15855657|NCT03997149|Behavioral|Acute Laboratory Stressor|The TSST was 20 minutes long and consisted of a five-minute instructional period where participants listened to a pre-recorded tape; a five-minute speech preparation period; a five-minute challenging serial subtraction task; and a five-minute videotaped public speaking task in front of a panel of three evaluative, non-affirming judges dressed in white coats.
15855658|NCT03997149|Behavioral|Low affect video|The 20-minute TSST was replaced with a 20-minute low-affect educational film screening.
15855659|NCT03997136|Procedure|Supratentorial high grade gliomas resection.|Total, near total or subtotal/debulking resection of the brain supratentorial high grade gliomas
15855660|NCT03997123|Drug|Capivasertib|400 mg (2 oral tablets) given on an intermittent weekly dosing schedule. Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week off-treatment within each 28-day treatment cycle. Study treatment will be continued until disease progression unless there is evidence of unacceptable toxicity, or if the patient requests to stop the study treatment.
15855661|NCT03997123|Drug|Paclitaxel|80 mg/m2 concentrate for solution for infusion, 3 consecutive weekly infusions of 80 mg/m2 (given on Day 1 of Weeks 1, 2, and 3), followed by 1 week off-treatment within each 28-day treatment cycle. Paclitaxel treatment will be continued for at least 6 cycles unless the patient experiences unacceptable toxicity that is attributed directly to treatment with paclitaxel.
15855662|NCT03997123|Drug|Placebo|Placebo: Oral tablets. 400 mg of Placebo (2 tablets) BD given on an intermittent weekly dosing schedule. Dosed on Days 2 to 5 of Weeks 1, 2, and 3 followed by 1 week offtreatment within each 28-day treatment cycle
15855663|NCT03997110|Radiation|Short course palliative radiation.|Week 1: Patients in the experimental arm will be treated with short course radiotherapy (25Gy/5#). The dose fractionation of 25 Gy in 5# over a week will be used. Week 4: Patients who have almost complete clinical response will be evaluated for brachytherapy will receive the appropriate brachytherapy procedure depending on the tumor response to a dose of 6-8Gy x 2-3#. The patients who will be found unsuitable for brachytherapy will be kept under observation. Week 12: After treatment completion, response assessment will be done using following parameters: • Pain assessment using numerical pain rating scale on 0-10 • Vaginal bleeding- yes/no • Vaginal discharge- yes/ no • Analgesic use- WHO ladder and dosing • QOL QC30, QLQC15 Pall, QLQC Cervix 24 • Disease response • Acute toxicity. Follow up: Patients follow up will be utilizing standard of care imaging and lab investigations used for the patients. Patients will be evaluated every 3 months for the study duration.
15855664|NCT03997110|Radiation|Long course palliative treatment.|Week1: All the patients will receive external sitting of radiation treatment, first fraction of 10 Gy. Week4: All the patients will receive external sitting of radiation treatment, second fraction of 10 Gy. Week7: Patients who have almost complete clinical response will be evaluated for brachytherapy will receive the appropriate brachytherapy procedure depending on the tumor response to a dose of 6-8Gy x 2-3#.The patients who will be found unsuitable for brachytherapy will receive another sitting of external radiation, third fraction of 10 Gy. Week 12: After treatment completion response assessment will be done using following parameters: • Pain assessment using numerical pain rating scale on 0-10 • Vaginal bleeding- yes/ no • Vaginal discharge- yes/no • Analgesic use- WHO ladder and dosing • QOL QC30, QLQC15 Pall, QLQC Cervix 24 • Disease response • Acute toxicity
15855665|NCT03997097|Drug|Sildenafil|Patients randomised in the group 1 will receive sildenafil in 3 oral doses of 20 mg per day
15855666|NCT03997097|Drug|Placebos|Patients randomised in the group placebo in 3 oral doses of per day
15855667|NCT03997084|Other|phone interviews|phone interviews
15855668|NCT03997071|Other|functional outcome measurement|functional outcome measured in terms of joint position sense analysis, isokinetic muscle strength measurements, gait analysis, drop jump and single leg hop tests, and balance tests
15855767|NCT03996317|Other|Room air|Avoidance of hyperoxygenation
15855669|NCT03997058|Other|Auricular point pressure therapy|Use a hard and smooth pill to adhere to the center of the 0.7×0.7cm tape. Hold the puncture clip on the part of the ear which is selected, and give appropriate pressure (揉) to make the patient have heat, hemp, Swelling and painful feeling; patients with sputum press 3-5 times a day, each time 1-2 minutes per hole, and must be pressed once every 15-30 minutes before going to bed every night. Press the point pressure method (press the ear point with a fingertip and press it loosely, each interval is 0.5 seconds. It is better for the patient to feel the swelling and slightly heavy tingling, and the force should not be too heavy. Generally, each time the hole can be pressed 27 times. Each time one side of the ear is selected, the two ear points are used alternately, staying in the summer for 1-3 days, and staying in the winter for 3-7 days.It is not appropriate to have local inflammation of the auricle, frostbite or surface skin ulceration.
15855670|NCT03997058|Drug|Oral estazolam medication|The first dose was started from 0.5mg, qn, and taken at 30min-1h before going to bed. If the dose is not effective, gradually increase the amount to 2mg, qn. If the patient has drug-induced liver damage and respiratory depression, it is necessary to stop the drug immediately. Hemorrhoids avoid drinking alcohol during medication.
15855671|NCT03997045|Behavioral|Supervised physical exercise program|Supervised physical conditioning program of two 60-minutes sessions per week during pregnancy, developed from gestational week 20 to 38. Each session consists of 25-30 minutes of cardiovascular exercise,15 minutes of strengthening exercises, 5 minutes of coordination and balance exercises and 10 minutes of pelvic floor muscles training.
15855672|NCT03997032|Dietary Supplement|Ocufolin|Ocufolin, Aprofol AG, Switzerland Dose: 1 capsule per day
15855673|NCT03997019|Procedure|opioid analgesia|opioid analgesia will be used with general anaesthesia
15855674|NCT03997019|Procedure|ESP block|ultrasound guided ESP Block before anaesthesia induction
15855675|NCT03997006|Drug|IV Aminophylline|IV Aminophylline (100 mg/8h)
15855676|NCT03997006|Drug|IV Neostigmine Methylsulfate + Atropine Sulphate|IV Neostigmine/Atropine mixture (20 μg/kg Neostigmine + 10 μg/kg Atropine)/8h
15855677|NCT03996993|Drug|Casodex, Axumin|Patients will receive hormone therapy if Axumin positive area appears.
15855678|NCT03996993|Radiation|Salvage Radiation, Axumin|Patients will receive salvage radiation therapy if Axumin positive area appears.
15855679|NCT03996980|Device|Custom-made foot orthoses Versus a flat insole|Compare the use of plantar orthoses (experimental group) with the use of a flat insoles (control group)
15855680|NCT03996954|Device|Alivecor recording|Alivecor recording and ECG recording from the same patient in very close temporal proximity
15855681|NCT03996941|Behavioral|Harm reduction of informal PrEP use|"Users attending the study center interested in PrEP use , as well as those who could benefit from it are invited to attend an information session in which issues are touched like the effectiveness and safety of PrEP, and the characteristics of the SeguiPrEP program. This program consists of periodic clinical controls (five during the first year and four in the following period) that include: physical examination, HIV and other STI screening, control of renal functions, estimation and promotion of PrEP adherence, monitoring of adverse events associated with PrEP and counseling.
~Those who decide to use PrEP or who are already using PrEP are asked to schedule an initiation visit."
15855682|NCT03996941|Other|PrEP follow up based on point of care testing|The study center has a point-of-care technology based laboratory, which allows obtaining immediate results in order to reduce the loss of follow-up.
15855683|NCT03996928|Other|Exercise|
15855684|NCT03996915|Device|Pdt Photodynamic Therapy|device irradiation with low intensity laser (wave length = 660 nm) 9 J (Joules) per point(6 points) and radiant 90 seconds PS will be applied in sufficient quantity to cover the middle third and back of the tongue and wait for 5 minutes.six points with the distances of 1 cm between them will be irradiated.
15855685|NCT03996915|Other|tongue scrapper|Tongue scrapping will be performed by the same operator in all patients. Posterior -anterior movements will be performed with the scrapper over the lingual dorsum. in order to promote the mechanical removal of tongue coating
15855686|NCT03996902|Behavioral|Tailored intervention|Brief motivational smoking intervention tailored to address smoking in the context of pain. Included a novel pain-smoking psycho education component, personalized feedback component, and elicitation of participant's pain-related goals to develop discrepancy between continued smoking and desired pain outcomes.
15855687|NCT03996902|Behavioral|Ask-Advise-Refer|The Ask-Advise-Refer intervention is commonly used in standard clinical practice.
15855688|NCT03996889|Device|Endovascular treatment of aneurysms of the popliteal artery by GORE VIABAHN® stent in elective surgery|"The intervention can be performed under local anesthesia (LA), regional locus (ALR) or general anesthesia (AG) (data collected) by first approach: percutaneous or conventional.
~The data collected are:
~Number of GORE VIABAHN® stent used (length and diameter of each)
~Embolization of collaterals and other related actions
~Operative complications
~Intraoperative fibrinolysis
~Collar cover> 2 cm
~Lack of overlap in the overlap zone (nb: between 4 and 8 cm above the joint spacing)
~Arteriography in profile, kink"
15855689|NCT03996876|Device|RePS (Resolving Psychological Stress) - Threat ABM Training|"This mobile app will aim to reduce neurobiological threat sensitivity with the ultimate goal of developing novel treatments for PTSD. The app can be used on an iPhone Operating System (iOS) compatible phone and involves a training program that aims to directly reduce threat sensitivity by modifying attention. The contents of the app will be the same for each user."
15855690|NCT03996876|Device|RePS (Resolving Psychological Stress) - Neutral Attention Training|This app will be a placebo attention bias modification that will be used on an iOS compatible phone. The placebo will contain only neutral words.
15855691|NCT03996863|Device|Otoband|Participants during infusion following chemotherapy will wear the Otoband set at normal power (effective) for four days following treatment and nausea outcomes will be recorded by questionnaire or by the investigator during site visits.
15855692|NCT03996863|Device|Placebo device|Participants during infusion following chemotherapy will wear the placebo device set at low power (6 decibels lower than normal power, ineffective power) for four days following treatment and nausea outcomes will be recorded by questionnaire or by the investigator during site visits.
15855693|NCT03996850|Procedure|Computed Tomography|Undergo SPECT/CT
15855694|NCT03996850|Other|Questionnaire Administration|Ancillary studies
15855695|NCT03996850|Procedure|Single Photon Emission Computed Tomography|Undergo SPECT/CT
15855696|NCT03996850|Radiation|Technetium Tc-99m Sestamibi|Given IV
15855697|NCT03996837|Other|Intra uterine infusion of platelet rich plasma|Platelet Rich Plasma (PRP) is a blood product with a high platelet and a normal plasma fibrinogen level. Given the effective factors of RPR in repairing damaged tissues, its application in the field of regenerative medicine has widely been interested over the last three decades. According to the literature, PRP is an effective and safe treatment in the fields of orthopaedics, dermatology, ophthalmology, and repair of neurological, vascular, and connective tissue damage, but its application in the field of infertility is limited to a few pilot studies in which the effects of PRP on endometrium and recurrent implantation failure (RIF) were investigated.
15855698|NCT03996824|Other|Peroperative collect of inner ear cells|"After obtaining an informed consent during the preoperative medical visit, and if a non-conservative approach (translabyrinthine or transotic) is decided, the collect of inner ear cells will be performed during surgical approach.
~The sample will be collect in a sterile tube, and carried to the laboratory were it will be placed bon cell culture."
15855699|NCT03996811|Other|Exercise education|weekly telephone consultations concerning exercise. we discussed whether participants' exercise fulfilled the prescribed intensity, duration, or frequency and whether the participants experienced any adverse effects.
15855700|NCT03996798|Other|Disability Case Manager|The DCM will act as key figure between the patient, the multidisciplinary team of the revalidation centre, the employers and other back-to-work services in order to increase vocational reintegration after an incident which caused a handicap or chronic disease.
15855701|NCT03996785|Behavioral|Walking in Urban setting|Walking for 60 minutes as described above
15855702|NCT03996785|Behavioral|Walking in nature setting|Walking for 60 minutes as described above
15855703|NCT03996772|Drug|Apixaban Oral Tablet|Factor Xa Inhibitor
15855704|NCT03996772|Drug|Dabigatran|Direct Thrombin Inhibitor
15855705|NCT03996772|Drug|Edoxaban Tablets|Factor Xa Inhibitor
15855706|NCT03996772|Drug|Rivaroxaban|Factor Xa Inhibitor
15855707|NCT03996759|Diagnostic Test|Laboratory diagnostic medicine|Metabolomic profiling and laboratory diagnosis including blood routine examination, liver function, renal function, myocardial enzyme, coagulation, arterial blood gas analysis, C-reactive protein, procalcitonin, B-type natriuretic peptide, myoglobin, lipopolysaccharide, cytokines (TNF-α, IL-1β, IL-6, etc.), immune cell markers (CD3+, CD4+, CD8+, etc.), and stool routine as well as intestinal microecology analysis.
15855708|NCT03996746|Diagnostic Test|No intervention|No intervention
15855709|NCT03996733|Other|Lecture|Principal investigator of the study will lecture about the ultrasound guided jugular central venous catheterization according to latest guidelines.
15855710|NCT03996733|Other|Demo Video|Investigators of the study prepared a detailed demo-video showing insertion of a jugular central venous catheter with USG guidance. Principal investigator will vocalize the video in real-time.
15855711|NCT03996733|Other|UltrasoundImaging|Participants will exercise the proper visualisation of the right jugular vein at T6 level with USG guidance on a human subject.
15855712|NCT03996733|Other|ModelTraining|"Participants will exercise the proper punction of juguler vein with USG guidance on the homemade jugular venous catheterization training model.
~Training model will include carotid artery, trachea and plaure in accordance with the real anatomy."
15855713|NCT03996707|Other|Weight Bearing|Immediate protected weight bearing in a CAM walking boot following foot & ankle surgery
15855714|NCT03996707|Other|Strict non-weight bearing|Strict non weight bearing for 6 weeks following foot & ankle surgery
15855715|NCT03996694|Drug|Belbuca 300 µg|Belbuca 300 µg buccal film
15855716|NCT03996694|Drug|Belbuca 600 µg|Belbuca 600 µg buccal film
15855717|NCT03996694|Drug|Belbuca 900 µg|Belbuca 900 µg buccal film
15855718|NCT03996694|Drug|Oxycodone 30 mg|Oxycodone 30 mg capsule
15855719|NCT03996694|Drug|Oxycodone 60 mg|Oxycodone 60 mg capsule
15855720|NCT03996694|Drug|Placebo|placebo buccal film and oral placebo
15855721|NCT03996681|Drug|methylcantharidimide tablets|"Drug: methylcantharidimide tablets
~Methylcantharidimide is a single molecule drug used for the treatment of primary liver cancer.
~Procedure: TACE
~Transcatheter arterial chemoembolization was performed by the injection of small embolic particles coated with chemotherapeutic agents selectively into an artery directly supplying a tumor."
15855722|NCT03996668|Other|Thigh High Compression Stockings|Thigh high compression stockings will be placed after induction of anesthesia and intubation.
15855723|NCT03996655|Drug|Sugammadex Injection [Bridion]|Reversal of neuromuscular blockers
15855724|NCT03996655|Drug|Neostigmine|Reversal of neuromuscular blockers
15855725|NCT03996642|Behavioral|Avatar Life Review|VoicingHan will screen-capture patient's storytelling performances as video files. Immediately before the first intervention, patients will complete an array of self-reported questionnaires to assess physical, spiritual, and psychological well-being and elicit relevant demographic and medical information. The assessments include the ESAS, FACIT-Sp subscale, and EORTC PAL 15. Subsequent administration of these questionnaires spaced 2-4 weeks apart will occur before each avatar session (pre-intervention). This will determine if intensity of the patient's symptoms have changed over the course of the intervention. Following completion of the Avatar session, a member of the research team will conduct a semi-structured, open-ended interview to assess patients' perception of intervention components and identify possible factors influencing intervention feasibility and any technical barriers.
15855726|NCT03996629|Other|Patient education and compliance|When the patient is enrolled in the intervention group, pharmacists provide medical education about the pathophysiology, medications, lifestyle, how to prevent, recognize and take care of bleeding events, etc. Establish a medical record for every follow-up examination and remind follow-ups by message, phone every month.
15855727|NCT03996616|Device|Head UP Position|"CPR will be performed manually before the patient is placed on a controlled mechanical elevation device who raises the head and thorax, also known as the head-up position (HUP-Elegard, Minnesota Resuscitation Solutions LLC, USA).
~Rescuers will perform CPR as continuously as possible during the placement of the Elegard, with a <10 second pause in chest compressions during the placement of this device. After performing (LUCAS AD + ITD CPR, see other interventions below) for 2 minutes with the head in the 'flat' position, the Elegard device will be turned on and the head will begin to rise as long as the patient is being treated with the ResQPOD-16 and the LUCAS AD. The head will be elevated to approximately 22 cm from the ground to the back of the occiput."
15855768|NCT03996291|Drug|Tolebrutinib|Pharmaceutical form: Film coated tablet Route of administration: Oral
15855729|NCT03996616|Device|New Automated CPR|Automated CPR will be initiated as soon as feasible using a new automated CPR mechanical compression device that provides full active compression-decompression CPR (LUCAS-AD, Stryker, USA).
15855730|NCT03996603|Drug|Conjugated Estrogens Cream|0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for 8 weeks
15855731|NCT03996577|Drug|Lidocaine|the experimental group will be given 1-1.5mg/kg lidocaine and then 2mg/kg/h
15855732|NCT03996577|Drug|placebo|the control group will be given the same volume of saline.
15855733|NCT03996564|Device|Battlefield Acupuncture|1-10 needles inserted in systematic nature as described by Battlefield acupuncture protocol.
15855734|NCT03996564|Drug|Acetaminophen|Acetaminophen 500mg-1000mg,
15855735|NCT03996564|Drug|Diclofenac|Diclofenac 50mg-75 mg orally
15855736|NCT03996564|Drug|Diazepam|Diazepam 5mg-10 mg intravenous or oral
15855737|NCT03996564|Drug|Hydrocodone|Hydrocodone 5mg/325mg-10mg/650mg mg
15855738|NCT03996564|Drug|Ketorolac|oral, or intramuscular Ketorolac 30mg-60 mg
15855739|NCT03996551|Behavioral|ExeRTiOn online resource|This is a 12-week online resource, specifically designed for new kidney transplant recipients. It includes dietary advice, physical activity advice, and recognized behavior change techniques. The participant will be monitored by a specialist physiotherapist and will receive messages of encouragement a 6 weeks and 12 weeks.
15855740|NCT03996538|Drug|Metformin Hydrochloride Extended-Release Tablets|Subjects will ingest 1500mg/day of metformin hydrochloride extended release. Immune responses will be examined prior to treatment, prior to flu vaccination, and after flu vaccination.
15855741|NCT03996538|Biological|Influenza Vaccine|All subjects will be vaccinated with high-dose influenza vaccine at the appropriate time of the year per current CDC and FDA recommendations
15855742|NCT03996525|Device|Electrical Stimulation|"Two-Stage Facial Reanimation (Standard Practice) with electrical stimulation for one hour at 20Hz (Experimental Procedure).
~Cross-Facial Nerve Graft (CFNG) immediately followed by electrical nerve stimulation proximal to the coaptation site on the donor facial nerve.
~Nine-to-Twelve Months later, Free Muscle Transfer (FMT) followed by electrical nerve stimulation proximal to the coaptation site in the intraoral incision."
15855743|NCT03996525|Device|Sham Treatment|"Two-Stage Facial Reanimation (Standard Practice) with sham electrical stimulation for one hour (Placebo).
~Cross-Facial Nerve Graft (CFNG) followed by placement of unelectrified electrodes proximal to the coaptation site on the donor facial nerve.
~Free Muscle Transfer (FMT) followed by placement of unelectrified electrodes proximal to the coaptation site in the intraoral incision."
15855744|NCT03996512|Other|Early Active Controlled Motion (EACM)|Early active controlled wrist motion rehab protocol using that will allow midcarpal row motion.
15855745|NCT03996499|Diagnostic Test|Stress echocardiography|"The course of the examination corresponds to the welcome of the patient, the search for contraindications and the performance of the stress ultrasound. During this stress ultrasound, the 3 indices (segmental kinetics, coronary reserve and myocardial perfusion) will be analyzed. The duration of the ultrasound is not lengthened (examination time: 20 minutes).
~The evaluation of the myocardial perfusion is carried out thanks to the use of the flash, modality not being part of the usual care.
~Indeed, during the examination, the power of the probe will be increased to evaluate the myocardial perfusion. The bubbles of the contrast medium are destroyed by applying a flash, that is to say a transient increase in the power of the ultrasonic beam. Systole after systole, on a recorded loop, the filling rate of the myocardium, which depends on the myocardial blood flow, is analyzed. The evaluation of the infusion is visual and qualitative."
15855746|NCT03996486|Drug|BAY1093884|Drug administered via subcutaneous injections once weekly for 6 weeks (= 6 doses)
15855749|NCT03996460|Drug|Placebo|"Fifteen (15) patients in group 1 will receive the sachet of matching placebo ( equivalent to a capsule of placebosugar pill) orally daily for 12 weeks (90 days) without food."
15855750|NCT03996460|Drug|192 mg powder of K0706|Fifteen (15) patients in group 2 will receive the sachet of 192 mg powder of K0706 ( equivalent to 96 mg capsule of K0706) orally for 12 weeks (90 days) without food.
15855751|NCT03996460|Drug|384 mg powder of K0706|Fifteen (15) patients in group 3 will receive the 384 mg powder of K0706 (equivalent to 192 capsule of K0706) orally daily for 12 weeks (90 days) without food.
15855752|NCT03996447|Drug|gadopiclenol|single intravenous (IV) bolus injection at a rate of 2ml/second
15855753|NCT03996447|Drug|Gadobutrol 1Mmol/mL Solution for Injection Vial|single intravenous (IV) bolus injection at a rate of 2ml/second
15855754|NCT03996434|Drug|Gonadotropin|withholding gonadotropin administration for at least 24 hours
15855755|NCT03996434|Drug|Antagonist|Cetrorelix acetate 0.25 mg
15855756|NCT03996421|Dietary Supplement|nutritional iron (14 mg) supplement in form of ferrous fumarate|nutritional iron (14 mg) supplement in form of ferrous fumarate
15855757|NCT03996421|Dietary Supplement|ferrous fumarate + 15 g GOS|nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (15 g GOS)
15855758|NCT03996408|Drug|Anlotinib|a multi-target receptor tyrosine kinase inhibitor
15855759|NCT03996408|Drug|TQB2450|TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
15855760|NCT03996382|Diagnostic Test|DPD Scintigraphy|Confirms/Refutes diagnosis of cardiac amyloidosis.
15855761|NCT03996369|Drug|Etrasimod|Etrasimod 2 mg tablet by mouth, once daily up to 12-Week Induction Treatment Period
15855762|NCT03996369|Drug|Placebo|Etrasimod matching placebo tablet by mouth, once daily up to 12-Week Induction Treatment Period
15855763|NCT03996356|Other|No study intervention - observational study|This is an observational study where the comparative groups will be determined by the genetic variants (SNPs) of subjects and not an intervention, per se.
15855764|NCT03996343|Device|Endotracheal intubation|COMPLETE
15855765|NCT03996343|Device|Laryngeal mask airway|COMPLETE
15855766|NCT03996330|Diagnostic Test|taqman array card|The array card contains multiple PCR reactions for microbial pathogens, extracted microbial nuclear material from lavage or blood is run on the card to detect pathogen specific sequences by polymerase chain reaction.
15855774|NCT03996252|Drug|Calcipotriene 0.005% Foam|Application of calcipotriene foam in conjunction with generic efudex cream to the scalp for four consecutive nights for the treatment of scalp actinic keratoses
15855775|NCT03996252|Drug|Efudex 5% Topical Cream|Application of generic efudex cream in conjunction with calcipotriene foam to the scalp for four consecutive nights for the treatment of scalp actinic keratoses
15855776|NCT03996239|Behavioral|exercise (walking)|Exercise treatment will consist of individualized walking delivered up to 5 times weekly. This trial will evaluate one dose of exercise (i.e., ~300 mins/wk following a non-linear dosing schedule) in both cohorts. Patients will have the option to receive exercise treatment at MSK or at their residence. Home-based exercise will be implemented and monitored using a telemedicine approach (i.e.,TeleEx) established in the Exercise-Oncology (ExOnc) Service
15855777|NCT03996239|Other|plasma samples|Plasma samples will be obtained at baseline.
15855778|NCT03996239|Other|blood draw|fasting blood
15855779|NCT03996226|Drug|E7386|E7386 oral tablets.
15855780|NCT03996213|Other|head down position|Head-down position will be achieved by 30 degrees tilting of the whole operating table 1-minute before induction of anesthesia. The position will be maintained for 15 minutes after induction of anesthesia
15855781|NCT03996213|Other|leg elevation position|Leg elevation position will be achieved by raising the patient legs for 30 cm using two standard pillows positioned under the heels 1-minute before induction of anesthesia. The position will be maintained for 15 minutes after induction of anesthesia
15855782|NCT03996200|Device|MINIject CS627 implant|"MINI SO627 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant (CS627) and a single operator delivery tool.
~The delivery tool is a single-use tool, designed for inserting the CS627 implant into the suprachoroidal space in the eye."
15855783|NCT03996174|Other|Interview|Interview bases on the use of an interview guide, during one hour maximum
15855784|NCT03996161|Other|patient position|After the induction of anesthesia, mask ventilation is performed in the supine and semi-sitting position in a cross-over, randomized order.
15855785|NCT03996148|Drug|Remifentanil, Propofol, and Desflurane|Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Propofol - titratable; initial starting dose 75 mcg/kg/min Desflurane 0.5 MAC
15855786|NCT03996148|Drug|Remifentanil, Dexmedetomidine, and Desflurane|Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Dexmedetomidine - titratable; initial starting dose 0.5 mcg/kg/hr Desflurane 0.5 MAC
15855787|NCT03996148|Drug|Remifentanil and Desflurane|Remifentanil - titratable; initial starting dose 0.05 mcg/kg/min Desflurane - titratable
15855788|NCT03996135|Device|Cannulation with AccuVein AV400|Cannulation using AccuVein AV400 device
15855789|NCT03996122|Other|fMRI|3 fMRI (TO, Month 2 and Month 6) 3 BDNF samples (TO, Month 2 and Month 6)
15855790|NCT03996109|Behavioral|Aim2Be smartphone app system|Youth-parent dyads will receive the LiGHT program (addressing healthy eating, physical activity, screen time and sleep) via the Aim2Be smartphone app for 1 year. It provides personalization beginning with creation of an avatar and identifying user motivations, offers progressive goal-setting considering readiness, sub-tasks, milestones, self-monitoring tools with feedback and positive reinforcement. It applies behaviour change techniques, provides a knowledge centre, simulation narratives to enable decision making, and separate social exchange platforms for parents and youth to share ideas and challenges with peers. A Virtual Coach has been programmed using motivational interviewing theory. Gamification includes elements of choice, challenge, uncertainty, discovery, and kudos for achieving outcomes in the process of developing motivations, skills and mastery.
15855791|NCT03996109|Behavioral|BnLt smartphone app|Youth-parent dyads will receive a simple app called BnLt for 1 year. It provides web-links to external websites that provide information and tips on healthy eating and activity, including the Canada Food Guide, Canadian Society of Exercise Physiology recommendations for physical activity, screen time and sleep for youth, and other resources.
15855792|NCT03996083|Other|Multicomponent exercise intervention|"Strength exercises were focused on lower limb strengthening. Individual bilateral intensities were calculated to estimate one repetition maximum (1-RM) for the leg and arm. This test was performed on the 2nd and 7th weeks of the intervention. A gradual and progressive intensity starting at 40% 1-RM and up 70% 1-RM was used. No external loads were applied to the rest of the exercises due to their complex execution technique and subsequent risk of adverse events. In these cases, training progression was achieved through volume (number of repetitions) and execution velocity increments.
~Balance exercises included standing with their feet together, semi-tandem, tandem and one-legged stand positions and moving on to dynamic exercises (circuits, stepping and so on). Difficulty was increased by reducing arm and base support and by varying the type and complexity of exercises. An individualized progression was applied to each participant based on their progress throughout the intervention."
15855793|NCT03996083|Other|Walking intervention|"To comply with the walking goals, walking distance was calculated based on each participant´s performance on the 6-minute walking test and using a rule of thumb. Therefore, every participant had an itinerary to follow to comply with the minimum walking time each week. Distance rather than time was used with participants for practical reasons and the inability of most of them to measure time. Moreover, time and distance were individually adapted according to each participant´s performance on the previous week.
~To ensure that participants complied with the walking goals, each of them (if they were cognitively able) was given a record sheet in which they had to write down their everyday walking routines. In addition, the caregivers were also informed about the walking routines and ensured that those participants who needed close supervision had someone to walk with and filled the sheet of those that were unable to do so."
15855794|NCT03996070|Procedure|Laser therapy|Erbium YAG laser
15855795|NCT03996057|Drug|Methenamine Hippurate 1000 MG|Discussed in arm/group description
15855796|NCT03996057|Drug|Vaginal estrogen|Any form of low dose vaginal estrogen, whether ring, cream, tablet, or capsule. Depends on what patient is already using.
15855797|NCT03996057|Dietary Supplement|D-mannose|Powder or tablet, depending on what patient is already using.
15855798|NCT03996044|Other|Teeth brushing and flossing|All participants will be instructed to brush with dentifrice containing amine fluoride in their composition (Elmex®) and floss with dental flossing, 3 times a day after meals for 30 days.
15855819|NCT03995810|Dietary Supplement|Carnosine, capsulle, 2 g/day, 8 weeks|We will administer supplemental carnosine (2 grams per day) for 8 weeks
15855820|NCT03995797|Procedure|Laser therapy|Erbium YAG laser
15855799|NCT03996044|Other|Tongue scraping|Tongue scraping will be performed by the same operator on all participants. Posterior-anterior movements will be performed with the scraper over the tongue dorsum, followed by cleaning the scraper with a gauze. This procedure will be performed ten times in each patient, in order to standardize the mechanical removal of the tongue coating.
15855800|NCT03996044|Radiation|Antimicrobial Photodynamic Therapy (aPDT)|One session of aPDT will be performed with the photosensitizer (PS) urucum manipulated at a concentration of 20% (Fórmula e Ação®) in spray, to be applied in sufficient quantity to cover the middle third and back of the tongue (5 sprinkles) for 5 minutes for incubation. The excess will be removed with a sucker in order to keep the surface wet with the PS itself, without using water. Six points with a distance of 1 cm between them will be irradiated, considering the halo of light scattering and effectiveness of aPDT. The apparatus shall be precalibrated at wavelength 440-480nm for 60 seconds per point, irradiance of 450mW/cm and the light shall be irradiated so that a halo of 2cm diameter is formed per point.
15855801|NCT03996044|Biological|Probiotics|Pharmacy-manipulated capsules containing strains of Lactobacillus salivarius WB21 (6.7 x 108 CFU) and xylitol (280mg) will be used. Forty-two capsules will be delivered for each patient, who should take 1 capsule 3 times a day after meals for 14 days.
15855802|NCT03996031|Device|Plan to Thrive smartphone application|All participants in this single-arm pilot study will receive access to Plan to Thrive. This mobile care management program is comprised of modules including educational interventions, health behavior trackers containing built-in reminders, symptom monitoring, and navigator services (see attached content). Access to intervention modules and individualized navigator services according to patients' needs as captured by 1) their patient-reported outcome (PRO) assessments via Plan to Thrive's symptom monitoring feature, and 2) patient requests.
15855803|NCT03996018|Other|T-cell lymphocyte responses|T-cell lymphocyte responses to human immunodeficiency virus (HIV) with and without concomitant herpesvirus infections (specifically, the persistence of HIV-specific human CD8 T-cells in the context of antiretroviral therapy (ART).
15855804|NCT03996005|Procedure|Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue|Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Prostate Tissue
15855805|NCT03995992|Behavioral|sport|10 days of sport (diving or multisport), once training per day
15855806|NCT03995979|Other|4 Day Protein Restricted Diet|Subjects will follow a 4 day protein restricted diet using Scandishake® mixed with almond milk which will be provided. They may also drink water. No food, other beverages, or alcohol may be consumed. The amount of diet to be consumed will be calculated for each patient based upon resting energy expenditures plus additional energy needs. These will be consumed by the study subjects at home in an unrestricted manner, in that they may be consumed at any point of time in the day.
15855807|NCT03995966|Behavioral|Noncontingent Reinforcement (NCR)|This treatment for ASIB is based on reinforcer competition. Noncontingent Reinforcement (NCR) will consist of first conducting a competing stimulus assessment (CSA) to identify stimuli (toys, massagers, etc.) associated with reductions in ASIB and high levels of engagement. Treatment then involves NCR in which alternative sources of reinforcement are made freely available to compete with reinforcement maintaining ASIB. Providing additional sources of reinforcement is thought to decrease ASIB by producing a shift in the allocation of responding toward accessing the newly available reinforcement. Additional, more restrictive components may be added if the competing stimuli (CS) are ineffective in reducing ASIB. These additional components are applied in accordance to the least-restrictive treatment model and include response blocking, response reduction procedures, protective equipment, or mechanical restraint.
15855808|NCT03995966|Behavioral|Combination Treatment|Combination Treatment is based on the same principles as NCR, but differs in three ways: 1) It includes three pre-treatment assessments that seek to establish competing stimuli, tasks, and self-control equipment through prompting and reinforcement; ; 2) Intensive training in each of these components is conducted to strengthen skills needed to fully access available reinforcement to compete with ASIB; and 3) Combination treatment is assessed, which includes the noncontingent delivery of competing stimuli and differential reinforcement of alternative behavior to reinforce engagement with competing tasks, and use of alternative self-control equipment. This will increase the amount and vary the sources of alternative reinforcement to more effectively reduce ASIB and self-restraint. Restrictive components may be applied as described for the NCR treatment.
15855809|NCT03995953|Behavioral|SHIELD intervention (Support for HIV Integrated Education, Linkages to care, and Destigmatization)|The SHIELD intervention includes a three-session, six-module program for AGYW that increases knowledge, skills, and self-efficacy to engage along the HIV prevention and care continuum, and a two-session, four-module program for family members to increase social support. In addition, the SHIELD intervention includes youth clubs to foster peer support.
15855810|NCT03995953|Other|Integrated wellness care (IWC) clinics|IWC clinics will be created within health facilities where AGYWs can receive sexual and reproductive health services, including HIV testing and treatment, family planning, sexually transmitted disease screening and treatment, and HPV vaccination in a youth-friendly environment.
15855811|NCT03995927|Other|Data collection and analysis|Only radiation oncology patients data from medical records regarding treatment, demographics and follow-up visits will be collected and logged by investigators.
15855812|NCT03995927|Other|Quality of Life Questionnaire|Participants will be asked to complete a set of short forms at first visit and post-treatment visits. If participant has a routine visit about 3 months after treatment, participant will be asked to complete a final form that is optional.
15855813|NCT03995901|Biological|FCR001|FCR001 is a cryopreserved allogeneic stem cell therapy derived from mobilized peripheral blood of the kidney donor that is delivered as a single dose with a non- myeloablative conditioning regimen. FCR001 contains the donor's CD34+ cells, facilitating cells, and αβ T cells.
15855814|NCT03995888|Drug|rhPSMA-7.3 (18F) Injection|Radioligand for PET CT scanning
15855815|NCT03995862|Other|Questionnaire|A questionnaire should be completed by the patient the day of inclusion. Health data will be collected in patients medical file from inclusion to the date of the end of study (i.e. no follow-up for the last patient included and a maximum of three years of follow-up for the first patient included).
15855816|NCT03995849|Diagnostic Test|Cone Beam CT Scan|In this study, children will receive one CBCT scan before starting RT as part of standard approach. Then after RT, another CBCT scan will be used to measure movement between the beginning and end of RT.
15855817|NCT03995836|Device|CPAP|Decision of CPAP treatment is according to clinical guidelines
15855821|NCT03995784|Biological|Coagulation Factor IX variant|Single intravenous injection of CB2679d/Dalcinonacog alfa
15855822|NCT03995784|Biological|Coagulation Factor IX variant|Daily subcutaneous injections of CB2679d/Dalcinonacog alfa for 28 days
15855823|NCT03995771|Other|Questionnaire delivery|A questionnaire including questions regarding prognostic factors for knee pain will be delivered to children and adolescents (8-19 years old) presenting to general practice with knee pain
15855824|NCT03995758|Device|MOSES|software based modulation of the laser energy delivered from the homium laser source. The software changes the pulsed laser to have two peaks of energy - one to displace water in front of the stone and a second to deliver the laser energy to the stone
15855825|NCT03995745|Behavioral|Medication adherence and financial incentives|Provision of wireless devices and financial incentives to motivate medication adherence among HIV-positive adults who have not reached viral suppression.
15855826|NCT03995732|Drug|PC-SOD|PC-SOD will be dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization.
15855827|NCT03995732|Drug|placebo|Placebo will be dissolved in 10 mL of 5% glucose injection and intravenously administrated before recanalization.
15855828|NCT03995719|Other|Preoperative education|65 patients were instructed to a preoperative stoma-education program
15855829|NCT03995719|Other|Postoperative education|73 patients, receiving the same information in postoperative period.
15855830|NCT03995706|Drug|Sacituzumab Govitecan|All 20 subjects will receive study drug Sacituzumab Govitecan preoperatively. Intraoperative tissue collection will follow with contemporaneous CSF (depending on tumor location) and whole blood (serum) sampling. Samples will be tested for total SN-38and free SN-38, as well as SN-38G. Following recovery from surgery, patients will resume treatment
15855831|NCT03995693|Dietary Supplement|Solution ingestion|Two ingestion modalities will be attributed (participant is blinded) in random order: a placebo and a glucose solution. The placebo contains water and a non-caloric sweetener (stevia) in order to reproduce the taste of the glucose solution. The glucose solution contains 6% glucose per volume, labelled with 13C. Both solutions will be administered in 8 doses: a bolus (333 mL) at rest, 30 minutes before the start of exercise, 167 mL immediately before exercise, 167 mL every 15 minutes during arm cranking, 125 mL immediately before concentric or eccentric pedalling and at 15 and 25 minutes of this last exercise period. In total, 1250 mL of solution will be administered during the experimental protocol.
15855832|NCT03995693|Behavioral|Constant load arm cranking|The participants will perform 45 minutes of arm cranking on a specialized ergometer at a power output corresponding to 30% of their concentric cycling VO2max, previously measured.
15855833|NCT03995693|Procedure|Expired gas sampling|Subjects will be asked, twice, to provide a forced expiration into a 10 mL plastic tube in order to collect a sample expired gases. This procedure will be done immediately before blood sampling and ingestion of the solution.
15855834|NCT03995693|Procedure|Indirect respiratory calorimetry|A mouthpiece and nose plug will be placed on the subject and expired gases will be analyzed by a metabolic cart during 3 minutes. This procedure will be done immediately before expired gas collection, blood sampling and ingestion of the solution.
15855835|NCT03995693|Procedure|Blood sampling|A catheter will be inserted in an antecubital vein and a saline solution will be continuously perfused to maintain vein open. 10 mL of blood will be collected immediately before ingesting the solution for a total of 80 mL.
15855836|NCT03995693|Behavioral|Measure of maximal voluntary contraction force production|Maximal voluntary bilateral knee extensions (3 trials of 3-4 seconds each) will be performed on a chair equipped with force sensors to measure peak force production. These measurements will be done before the first ingestion, immediately before exercise, during the transition between arm cranking and concentric or eccentric cycling, and at the end of the exercise protocol.
15855837|NCT03995693|Diagnostic Test|Measure of muscle electrical activity (EMG)|Surface electrodes will be placed on the biceps and quadriceps to measure EMG throughout the exercise protocol.
15855838|NCT03995693|Diagnostic Test|Measure of central and cutaneous temperatures|Wireless sensors will be placed on the skin of the arm, chest, back, abdomen, thigh and calf using adhesive tape. A wireless thermometric pill will be ingested the morning of the experiment. These will allow the measurement of skin and central temperatures throughout the exercise protocol.
15855839|NCT03995693|Diagnostic Test|Measure of perceived exertion, pain perception and affective response|"100 points scales (CR100) will be used to measure perceived exertion and pain perception immediately before ingesting the gas sampling. At the same time, affective responses will be assessed using the Feeling scale."
15855840|NCT03995693|Procedure|Measure of sweat and urine production|Sweat production and sampling will be performed by measuring body weight before and after exercise, after voiding the bladder. Mass loss through the urine and gases will be accounted for in order to compute sweat production. A sweat sample will be collected using a cotton gauze placed into a plastic collector affixed in the upper back of the participants. A urine sample will be taken from the urine collected at the end of the exercise period. Urine and sweat volumes along with respective urea concentrations will be used to compute protein oxidation during exercise.
15855841|NCT03995680|Drug|Mebendazole|Treatment with one of the two formulations of mebendazole. The only difference between both arms is the type of formulation of the drug: chewable versus swallowable tablet.
15855842|NCT03995667|Other|Questionnaire Administration|Ancillary studies
15855843|NCT03995667|Device|Tumor Treating Fields Therapy|Optune-Tumor Treating Fields (TTFields). Transducer arrays affixed to scalp, worn continuously.
15855844|NCT03995641|Drug|marcaine and kenalog|Trigger point injection (consisting of 9 cc 0.5% Marcaine and 1 cc kenalog) may be given at time of surgery if patient is randomized to receive the injection
15855845|NCT03995628|Drug|Dexamethasone|One dose of dexamethasone (0.5 mg/kg) on post-operative day 3 after tonsillectomy
15855846|NCT03995615|Procedure|scaling and root planing|"After initial clinical evaluation, supra gingival calculus removal will be done. GCF samples will be collected from the control and test groups (Baseline samples) using paper strips (ORAFLOW). ® Group III patients will undergo a through oral hygiene instructions, full mouth supra-gingival and sub- gingival scaling and root planing clinical parameters will be re-recorded 6 weeks later and a 2nd GCF samples will be collected from selected test site from each patients following periodontal intervention.
~All the samples will be placed in eppendorf vials containing the buffer solution and samples will be stored at -800 c until the time of analysis by Enzyme -linked immune sorbent assay kit (ELISA) (GENX BIO) TM"
15855847|NCT03995602|Dietary Supplement|Dragon fruit juice drink|Dragon fruit drink containing 24 g of freeze-dried dragon fruit powder dissolved in low nitrate water.
15855848|NCT03995602|Dietary Supplement|Placebo|Drink with macro- and micro-nutrient matched against the intervention drink.
15855849|NCT03995589|Other|Walking|Technology-guided semi-supervised walking therapy
15855850|NCT03995589|Other|Control|Go Home and Walk advice
15855851|NCT03995576|Other|thoracic sympathetic ganglion block|thoracic sympathetic ganglion block which needle reaches posterolateral vertebral body
15855852|NCT03995563|Drug|Dexamethasone|"Continous epidural injection will be done during 10 days. D group will be injected a 0.19% ropivacaine 8mL and dexametasone 1mg every other day during 10 days.
~."
15855853|NCT03995563|Drug|Ropivacaine|Continous epidural injection will be done during 10 days Both group will be injected a 0.19% ropivacaine 8mL every other day during 10 days
15855854|NCT03995550|Drug|LEO 142397|A compound in development by LEO Pharma A/S
15855855|NCT03995550|Drug|Placebo|Placebo
15855856|NCT03995537|Biological|blood sample|"Samples will be collected at the inclusion and repeated if necessary before LT, including one 4 mL EDTA sample and one 4 mL Heparin sample and one 2.5 mL PAXgene® sample, allowing the HLA-DR assay to be performed with also plasma aliquots and messenger RNAs.
~Same samples will also be collected :
~between inclusion and LT in case of major clinical change
~During the pre-transplant follow-up 3 months after inclusion, for patients who have not been transplanted within 3 months after inclusion
~at day 1 after LT
~2 times a week after the LT for a maximum of 1 month
~Biological data will be collected at those different times."
15855857|NCT03995511|Procedure|Bilateral Sagittal Split Osteotomy|Surgical correction of lower jaw deformity by performing bilateral intraoral sagittal osteotomy of the mandible under general anesthesia.
15855858|NCT03995498|Other|Physical activity|Participants will engage in team sports exercise twice a day: from 9h:30 to 10h:30 and from 11h:00 to 12h:00.
15855859|NCT03995498|Other|FreeStyle Libre|Glucose levels will be measured by the FreeStyle Libre
15855860|NCT03995498|Other|SenseWear Armband|Energy expenditure during physical activity sessions will be measured with the SenseWear Armband.
15855861|NCT03995485|Drug|KW-136 capsule|KW-136 60 mg was provided in a single capsule of 60 mg.
15855862|NCT03995485|Drug|Sofosbuvir|Sofosbuvir was provided in a single tablet of 400 mg.
15855863|NCT03995472|Drug|SHR-1501|Administered subcutaneously
15855864|NCT03995472|Drug|SHR-1316|Administered intravenously
15855865|NCT03995446|Device|low-level laser|low level laser emission on specific acupuncture points
15855866|NCT03995446|Device|Sham laser|Sham laser
15855867|NCT03995420|Behavioral|Virtual Reality Therapy (V-NeST)|V-NeST is a 12-session therapy using psychological intervention principles based on Cognitive Remediation and CBT partly based in Virtual Reality.
15855868|NCT03995420|Other|Treatment as Usual|multi-modal treatment consisting of different therapies defined by the treating team. These will include regular contact with a care coordinator and medication management by a psychiatrist.
15855869|NCT03995407|Dietary Supplement|Peptamen®|Participants in the intervention arm will be categorised into those who are not currently taking oral nutritional supplement and those who are currently on oral nutritional supplements. Those who are not currently taking oral nutritional supplement will be started on Peptamen® while those who are currently on oral nutritional supplements will have to convert to Peptamen® solely. The dietician will determine the amount of Peptamen® required per day based on the recommendations of the product information. Should the participant's daily protein requirement not be met be Peptamen® alone, the dietician will recommend additional whey protein to be added in the form of Beneprotein® Instant Protein Powder. Beneprotein® is a concentrated source of high-quality whey protein that can be added to most foods, liquids or enteral formulas.
15855870|NCT03995407|Other|Usual Care|"Participants receive usual care. They will be categorised into those who are not currently taking oral nutritional supplement and those who are currently on oral nutritional supplements (non-100% whey i.e. not on Peptamen® or Beneprotein®). They will consume their regular diet in accordance with the dietician's recommendations."
15855871|NCT03995394|Other|Positive Reinforcement Text Message|"A text message comprising the words, Great job! We're so proud of you! Keep up the good work!"
15855872|NCT03995381|Other|Decision aids|Shared decision making with decision aids
15855873|NCT03995368|Other|Electroencephalography|The investigators will use EEG combined with measures of cognition and clinical interviews to explore connections between these measures and electrical activity in the brain in Veterans with a diagnosis of schizophrenia or TBI, and healthy controls.
15855874|NCT03995342|Dietary Supplement|Inulin|Inulin 15 grams after dissolution by mouth， every morning for three months.
15855875|NCT03995342|Dietary Supplement|Maltodextrin|Placebo (maltodextrin) 15g/d，Oral administration after dissolution15g/d，Oral administration after dissolution
15855876|NCT03995329|Other|IQOS|Acute effects of IQOS on pulmonary function, oxygen saturation, exhaled CO, heart rate and arterial blood pressure.
15855877|NCT03995316|Behavioral|Treatment As Usual + MMB 2.0|Women assigned to use MMB 2.0, along with NorthShore HealthSystem's well established usual care, will be guided by the program to move sequentially through 6 sessions, one of which becomes available for use each week, while interacting with engaging activities within each session along with recommended practice activities to encourage transfer of learning and skills to everyday routines. Content is presented using text, interactions, animations, and videos. MMB includes daily tracking and charting of mood and pleasant activities as well as online access to a library, covering a range of issues of concern to pregnant women and new mothers. Integrated text messages offer both motivational messages and links to access specific portions of session content in the MMB 2.0 program. The study coordinator will also provide up to 3 supportive coaching calls to each woman in the MMB 2.0 condition. These calls complement and thus are adjunctive to the MMB 2.0 program.
15855878|NCT03995316|Behavioral|Treatment As Usual Only|NorthShore HealthSystem's treatment as usual, or usual care, has been in place since 2003. Screen positive women randomized to this condition will receive social work assessment by phone, followed by community mental health referral as indicated. Referrals will vary by need and may include psychotherapy, support groups, or psychiatry. Referrals will include consideration of geographic proximity, insurance, and acuity. Consistent with routine practice, NorthShore staff will document time spent during evaluation and in making specific referrals.
15863127|NCT03937206|Dietary Supplement|Placebo|Corn Oil 1000mg
15855879|NCT03995303|Other|NCP and home-delivered meals|The dietitian (Ph.D. student) will perform an individual nutritional assessment focusing on dietary intake, activity level and weight of each participant, as a basis for developing an individualized nutrition care plan consistent with estimated nutritional requirements and nutritional rehabilitation goals. Total fluid, energy- and protein requirements will be estimated for each patient. Giving the group free food to fulfill protein-and energy needs.
15855880|NCT03995290|Other|3D Hip Model from Pre-operative CT scan|A printed 3D model will be created based off of the patient's standard of care preoperative CT scan.
15855881|NCT03995277|Dietary Supplement|Biotin|Daily intake of 10 mg or 50 µg per day
15855884|NCT03995251|Drug|Testosterone Supplementation|Intramuscular Testosterone Undecanoate 1000 Mg (4 ml volume in oily base) will be injected into the upper, outer quadrant of the buttock at 0, 6, 12,16,20, 24 weeks according to manufacturer recommendations
15855885|NCT03995251|Drug|Standard Medical Treatment|Standard Medical Treatment
15855886|NCT03995251|Other|Exercise|Exercise
15855887|NCT03995238|Behavioral|Error-augmentation gait training|Split-belt treadmill training to enhance between-limb asymmetry during treadmill walking, which is intended to force compensation and correction of step asymmetry during treadmill walking. The error-augmentation gait training program is delivered in 8 sessions over 4 weeks.
15855888|NCT03995238|Behavioral|Error-correction gait training|Metronome will be set to cue participants to overcorrect between-limb step asymmetry during treadmill walking, through use of asymmetrical metronome tones in a 2:1 ratio. The error-correction gait training program is delivered in 8 sessions over 4 weeks.
15855889|NCT03995238|Behavioral|Supervised walking|An active comparator intervention, in which a supervised treadmill walking program is delivered without attempt to correct step asymmetry. The supervised walking program is delivered in 8 sessions over 4 weeks.
15855890|NCT03995225|Behavioral|Smartband automatic smoking detection and brief mindfulness interventions|Smartband/smartphone based automatic smoking monitoring, notification and real-time brief mindfulness interventions
15855891|NCT03995212|Drug|CR845 1.0 mg|Oral CR845 1.0 mg administered twice daily
15855892|NCT03995212|Drug|Placebo|Oral Placebo administered twice daily
15855893|NCT03995186|Behavioral|Behavioural activation|4-week programme based on the behavioural activation treatment provided in the NHS IAPT services. The programme includes psychoeducation on the relationship between activity and depression, examining the depressed person's level of activity, helping them identify activities they would like to increase and supporting them in the planning and conduct of those activities.
15855894|NCT03995186|Behavioral|Activity monitoring|4-week programme where participants simply monitor their general daily activities in a diary.
15855895|NCT03995173|Device|repetitive transcranial magnetic stimulation|rTMS will be delivered with the Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P. The Magpro Cool Coil B65 A/P can be switched to active or placebo (A/P). The Magventure C-B60 coil will be used to deliver single TMS pulses for motor threshold determination.
15855896|NCT03995160|Procedure|Use of closed suction drainage following total knee arthroplasty|Use of closed suction drainage following total knee arthroplasty
15855897|NCT03995160|Procedure|Abstain of using a closed suction drainage|Abstain of using a closed suction drainage following total knee arthroplasty
15855898|NCT03995147|Drug|Pembrolizumab|"Pembrolizumab will be administered at a fixed dose of 200mg intravenously every 3 weeks in combination with R-CHOP for 6 cycles.
~Participants that respond to the combination regiment will continue to receive pembrolizumab 200 mg IV every 3 weeks for additional 35 cycles (2 years)."
15855899|NCT03995147|Drug|R-CHOP Protocol|R-CHOP chemo-immunotherapy will be administered in combination with Pembrolizumab
15855900|NCT03995134|Combination Product|Propofol and Remifentanil administered by TCI pump|Propofol, Remifentanil, Alaris PK (pharmacokinetic) infusion pump with TCI
15855901|NCT03995121|Radiation|[11C]APP311|It has been shown that [11C]APP311 (aka [11C]UCB-J) displays high specificity and selectivity for the synaptic vesicle protein SV2A. Since this protein is expressed ubiquitously in active synapses, this tracer has the potential to be a general purpose tool for quantitative imaging of synaptic density.
15855902|NCT03995108|Drug|Mavorixafor|Mavorixafor provided as 100 mg capsules.
15855903|NCT03995108|Drug|Placebo|Placebo matching to mavorixafor capsules
15855904|NCT03995095|Other|Therapeutic interview: kibo protocol|The kibo protocol is a therapeutic interview designed to address the spiritual needs of patients at the end of life.
15855905|NCT03995082|Other|Patient Reported Outcome Measure Survey result feedback|Patients will receive a graph of their results from the PROM survey each time they complete a survey
15855906|NCT03995069|Behavioral|3D|Practice generating grip force to the target shown on the computer screen in 3 dimensions.
15855907|NCT03995069|Behavioral|1D|Practice generating grip force to the target shown on the computer screen in 1 dimension.
15855908|NCT03995056|Behavioral|high-intensity aerobic interval training|"The intervention group will follow a high-intensity interval training protocol on a cycle ergometer for 2 times per week and 1 time an individualised home workout program to have a total exercise amount of 3 hours.
~Leisure time physical activity at baseline as well as during the intervention period will be assessed by Polar Active devices."
15855909|NCT03995043|Behavioral|Education|Receive educational SMS (text) messages about contraceptive use and family planning on SRH and access individually tailored educational resources through interactive voice response (IVR) services/system via PREVENT mobile platform.
15855910|NCT03995043|Behavioral|Personal Support|Contact with a female business owner within the community (hair saloons, tailors, female clothing stores) act as both a confidential, and non-judgmental resource to answer questions and provide counselling in SRH to study participants.
15855911|NCT03995043|Behavioral|Access to contraception|Will be provided by the mobile reproductive health team at contraceptive access points, and, at the health facility partners who will be providing full reproductive health services to program participants and will be the access points for Intra-Uterine Device (IUD) insertion where requested and medically suitable. Results of point of care urine HCG (pregnancy) testing (voluntary at enrollment and mandatory when accessing contraceptive services)
15863584|NCT03933449|Drug|irinotecan|IV infusion
15855912|NCT03995030|Diagnostic Test|massively paralleled sequencing|Whole genome sequencing libraries will be generated and sequenced in batches on the Illumina MiSeq. FASTQ files will be demultiplexed and then aligned to microbial genomes using Phylosift.
15855913|NCT03995017|Drug|Rucaparib|Rucaparib tablet
15855914|NCT03995017|Drug|Ramucirumab|Ramucirumab intravenous solution
15855915|NCT03995017|Drug|Nivolumab|Nivolumab intravenous solution
15855916|NCT03995004|Drug|Melatonin|Melatonin (N-acetyl-5-methoxytryptamine) is a neurohormone that is endogenously produced and secreted by the pineal gland in the brain following a circadian rhythm, with a plasma concentration highest at night and lowest during the day.
15855917|NCT03995004|Drug|Dexamethasone Sodium Sulphate 4mg/1mL|Dexamethasone is a glucocorticoid commonly used in orthognathic surgery to reduce postoperative facial edema by its potent anti-inflammatory effect
15855918|NCT03994991|Device|active TMS|Transcranial magnetic stimulation
15855919|NCT03994991|Device|sham TMS|Sham transcranial magnetic stimulation
15855920|NCT03994978|Procedure|elective sigmoidectomy|elective sigmoidectomy
15855921|NCT03994965|Drug|Pimavanserin 34 milligrams (MG) [Nuplazid]|Daily treatment with 34 mg per os for 6 weeks. Followed by a wash-out period up to 14 days, do to the theoretical risk of corrected QT interval (QTc) prolongation. Conventional anti-psychotic treatment will be initiated only upon normal ECG.
15855922|NCT03994952|Device|Sway Balance Application|Participants complete the modified Balance Error Scoring System as prompted on and iPad mini. It has 5 balance stances, double limb stance, right tandem, left tandem, right single, and left single leg balance for 20 seconds each. This will only be used as measurement, not an intervention.
15855923|NCT03994952|Device|Balance Tracking Systems|This is a force platform. Center of pressure data will be measured and recorded while participants are completing the modified Balance Error Scoring System. This will only be used as measurement, not an intervention.
15855924|NCT03994939|Behavioral|Families Talking Together (FTT)|FTT is an evidence-based program designed to increase parent-adolescent communication about sex in order to delay sexual debut and prevent negative SRH outcomes in young adolescents (aged 10 to 14). The FTT intervention has been delivered with efficacy in multiple settings, including schools and clinics (Guilamo-Ramos et al., 2011a; Guilamo-Ramos et al., 2011b).
15855925|NCT03994926|Device|Virtual Reality Eye Tracking after smoking Cannabis - HTC Vive Pro-Eye|Device measures smooth eye pursuit and response to light flash after pt smokes cannabis
15855926|NCT03994926|Drug|Cannabis cigarette - 4.0% THC|smoked cannabis 4.0% THC
15855927|NCT03994913|Biological|CAR-CD19 T Cells|"The CAR- CD19 T cells (study drug) used in this study are chimeric antigen receptor specifically expressing T cells targeting CD19.
~Fludarabine and Cyclophosphamide are used for lymphodepletion."
15855928|NCT03994900|Diagnostic Test|Blood sampling for HbNO assessment|Blood sampling
15855929|NCT03994887|Device|Experimental group|EEG acquisition system BioSemi (Amsterdam, the Netherlands), enabling real-time measurement and continuous recording of EEG on up to 128 leads.
15855930|NCT03994874|Drug|PolyCore (Polydextrin, L-Carnitine, D-xylitol)|A single nightly exchange, with 2 liters PolyCore solution, lasting 12-14 hours. Patients should remain on their prescribed heart failure medications and the same dosing schedule for the duration of the study unless investigators determine medically necessary to change.
15855931|NCT03994874|Drug|Medical therapy including loop diuretic (furosemide) daily dose up to 2.5 mg/kg/day,|During the study, patients should remain on their prescribed heart failure medications and the same dosing schedule for the duration of the study unless investigators determine medically necessary to change.
15855932|NCT03994861|Diagnostic Test|Assessment of disability and behavior (by questionnaires)|Assessment of disability and behavior (by questionnaires)
15855933|NCT03994848|Behavioral|Spirometry Group|Patients that are provided the incentive spirometer pre-operatively and instructed to use it for 4 cycles of 10 spirometry attempts on the day prior to surgery
15855934|NCT03994822|Device|Mechanical Thrombectomy using the pRESET Thrombectomy device|Clot removal using the pRESET Thrombectomy device
15855935|NCT03994822|Device|Mechanical Thrombectomy using the Solitaire Revascularization Device|Clot removal using the Solitaire Revascularization Device
15855936|NCT03994809|Other|Okada Purifying Therapy|The practitioner raises his/her hand forward towards the recipient with the palm directed toward the recipient. The practitioner uses his/her hands alternately during the administration of Okada Purifying Therapy. The distance between the palm and the body is usually 1-2 feet, with each session typically lasting 30 to 60 minutes.
15855937|NCT03994796|Drug|Abemaciclib|Given PO
15855938|NCT03994796|Drug|PI3K Inhibitor paxalisib|Given PO
15855939|NCT03994796|Drug|Entrectinib|Given PO
15855940|NCT03994783|Drug|Rituximab|2 intravenous infusions of rituximab or approved biosimilar given 14 days +/- 2 days apart.
15855941|NCT03994783|Drug|Methylprednisolone|Intravenous infusion of methylprednisolone
15855942|NCT03994783|Drug|Intravenous Immunoglobulin|High dose (2 g/kg total) or Low dose (100 mg/kg, n=7)
15855943|NCT03994783|Procedure|Plasma Exchange|Blood is removed from the patient and filtered to remove the plasma. Red and white blood cells and platelets are returned to the patient with replacement fluid.
15855944|NCT03994770|Diagnostic Test|Balanced Reach Assessment and Training Protocol|Three one-hour training sessions for one week in the Balanced Reach Training Protocol
15855945|NCT03994757|Behavioral|MRBI|The activities content is designed according to the children's daily routine and goals. It mainly involves bathing activities, eating activities, dressing activities, game activities, social and communication activities, and according to the needs of parents. In the treatment room, after the therapist and parents discuss the intervention methods and suggestions, they will demonstrate the intervention strategies and methods, and let the parents practice the practice, and the therapist will guide them. After discussing with parents, the therapist will give parents a homework related to children's daily routine, let the parents implement at home, and discuss with parents and record before each intervention.
15855946|NCT03994757|Behavioral|Control|Traditional treatment was directly performed for children in the treatment room by the therapist. The activity content was designed according to the children's goals. After each end of treatment, therapist will give parents a homework related to traditional treatments, let the parents perform at home, and know the parents' performance at home and record before each treatment begins.
15855947|NCT03994744|Drug|PD-1 inhibitor|Intravenous administration of Sintilimab (1200mg/3weeks)
15855948|NCT03994744|Drug|Metformin|"Metformin treatment will be given (day20) 1 week before the second administration of Sintilimab at a dose of 2000 mg daily (1000mg BID).
~To reduce GI toxicity, participants start Metformin at 1000 mg daily (500mg am, 500 mg pm) for 1 week."
15855949|NCT03994731|Biological|Pegloticase with MTX|Participants will receive MTX during the Tolerability Assessment Period then MTX during the run-in period then pegloticase with MTX for 52 weeks
15855950|NCT03994731|Biological|Pegloticase with placebo for MTX|Participants will receive MTX during the Tolerability Assessment Period then placebo for MTX during the run-in period then pegloticase with placebo for MTX for 52 weeks
15855951|NCT03994718|Other|Music intervention|The music therapist will work with subjects for up to 60 minutes each session.
15855952|NCT03994718|Other|Visual arts intervention|The visual artist will work with subjects for up to 60 minutes each session.
15855953|NCT03994718|Other|Creative writing intervention|The creative writer will work with subjects for up to 60 minutes each session.
15855954|NCT03994705|Biological|Descartes-11|CAR T-Cells
15855955|NCT03994705|Drug|Fludarabine|Pre-conditioning chemotherapy
15855956|NCT03994705|Drug|Cyclophosphamide|Pre-conditioning therapy
15855957|NCT03994692|Device|PEEK eminoplasty|making obstacle at eminence using patient specefic PEEK device
15855958|NCT03994692|Procedure|autogenous onlay grafting eminoplasty|making obstacle at eminence using chin graft
15855959|NCT03994666|Biological|allogeneic umbilical cord-derived mesenchymal stem cells|Injection of mesenchymal stem cells
15855960|NCT03994666|Biological|Placebo (NaCl)|Placebo injection
15855961|NCT03994653|Other|Risk Factor Questionnaire|For cases, the study recruiter at the Trust will present this in the clinic. Controls will complete this online or at home when volunteering to participate. The participant questionnaire will be completed by the participant.
15855962|NCT03994653|Other|Clinical Questionnaire|For cases, the study recruiter at the trust will complete this form together with the participant. Controls will not complete this form.
15855963|NCT03994640|Combination Product|Cannabis Cream|Topical, bilateral skin application of cannabis cream with self-massage of masseter muscles
15855964|NCT03994640|Combination Product|Placebo Cream|Topical, bilteral skin application of placebo cream with self-massage of masseter muscles
15855966|NCT03994614|Other|acupuncture|Patients in the experimental group will be given acupuncture treatment for 12 weeks prior to COS. The patients will be given three times acupuncture every week except menstruation. The acupuncture acupoint locations are as follows: head acupoint(Yintang, Shenting, Baihui), abdominal acupoint (Guanyuan, Zhongji), leg acupoint(Sanyinjiao, Zusanli),waist acupoint (Shenyu, Guanyuanyu）
15855967|NCT03994601|Drug|BMS-986288|Specified dose on specified days
15855968|NCT03994601|Drug|Nivolumab|Specified dose on specified days
15855969|NCT03994588|Procedure|Intraperitoneal Mesh hernia repair|The mesh will be inserted intraperitoneally for complex ventral hernia repair and fixed according the previously described ADMIR technique.
15855970|NCT03994575|Other|Guideline recommended feedback|The ACS Reflective III Pilot program is a quality assurance program where the decision to follow the recommendations and all treatment decisions related to patient care are left to the physician's discretion and feedback to the physician with their aggregate and individual patient data is intended as a quality assurance undertaking
15855971|NCT03994549|Drug|Dual GLP-1/GLP-2 Receptor agonists|Eight ascending doses of ZP7570
15855972|NCT03994536|Behavioral|A Person-Centred Transition Program to Empower Adolescents With Type 1 Diabetes in the Transition to Adulthood: the STEPSTONES-DIAB Project|Behavioral: Transition program Participants will be part of a transition program that aim to prepare them for adult life and adult care wich includes eight key components: 1. A transition coordinator; 2. Education on diabetes, treatments, health behavior, dealing with school, friends; 3. Telephone availability; 4. Information about the adult diabetes service: 5. Guidance of parents; 6. Meeting with peers: 7. A person-centered transition plan; and 8. Preparation and transfer to adult diabetes service.
15855973|NCT03994536|Other|Standard care|Participants allocated to this group will receive usual care, which includes regular follow-up visits in pediatric diabetes outpatient clinics. Usual care can vary across the two clinics, however, they all include meetings with a nurse and a physician.
15855974|NCT03994510|Other|Clinical and biological assessments - a 5 Years follow-up|During each visit, a clinical evaluation will be carried out, as well as the filling of hetero-questionnaires and self-questionnaires. Two biological collections will be made: one during the inclusion visit, and the other during the last visit, 5 years after inclusion.
15855975|NCT03994497|Other|Blood samples|Blood samples the day of the surgery and 4 times during the next year. Blood samples and histological slides taken at each biopsy and if there is suspicion of rejection of the graft
15855976|NCT03994484|Drug|HA121-28 tablets|Participants will receive oral HA121-28 at a starting dose of 25 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
15855977|NCT03994484|Drug|HA121-28 tablets|Participants will receive oral HA121-28 at a dose of 50 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
15855978|NCT03994484|Drug|HA121-28 tablets|Participants will receive oral HA121-28 at a dose of 100 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
15855979|NCT03994484|Drug|HA121-28 tablets|Participants will receive oral HA121-28 at a dose of 200 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
15855980|NCT03994484|Drug|HA121-28 tablets|Participants will receive oral HA121-28 at a dose of 300 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
15855981|NCT03994484|Drug|HA121-28 tablets|Participants will receive oral HA121-28 at a dose of 450 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
15855982|NCT03994484|Drug|HA121-28 tablets|Participants will receive oral HA121-28 at a dose of 600 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
15855983|NCT03994484|Drug|HA121-28 tablets|Participants will receive oral HA121-28 at a dose of 800 mg once daily at the 1st day in 0 cycle and for 21 days on a 28-day treatment cycle
15856009|NCT03994250|Other|Kinematic Alignment for total knee replacement surgery|Using Kinematic Alignment for total knee replacement surgery
15856010|NCT03994250|Other|Mechanical Alignment for total knee replacement surgery|Using mechanical alignment for total knee replacement surgery
15855984|NCT03994471|Drug|XyloCore Low Strenght, XyloCore Medium Strenght, XyloCore High Strenght|XyloCore Low Strenght: 0.7% Xylitol, 0.5% Glucose, and 0.02% L-carnitine - or - XyloCore Medium Strenght: 1.5% Xylitol, 0.5% Glucose, and 0.02% L-carnitine - or - XyloCore High Strenght: 2.0% Xylitol, 1.5% Glucose, and 0.02% L-carnitine
15855985|NCT03994471|Drug|1.36%, 1.5%, 2.27%, 2.5%, 3.86%, 2.25% Glucose PD Solution|Physioneal 35 or 40 (including Clear-Flex bag), Fixioneal 35 or 40, Dianeal or Dianeal Low Calcium have 1.36%, 2.27% or 3.86% glucose; Balance, Bicavera, Bicanova or Equibalance have 1.25%, 2.3%, 4.5% glucose.
15855986|NCT03994458|Behavioral|Smartphone Full version application|Android smartphone experimental application include: rehabilitative self-administered evidence-based exercises (Strengthening and stretching), ergonomics, and education related to low back pain. The application includes videos, photos, text, and reminders.
15855987|NCT03994458|Behavioral|Samartphone limited version application|Android smartphone placebo application include: ineffective content that does not help in treating low back pain. The application includes only five posts in the general instruction and advises section about proper nutrition and few irrelevant reminders.
15855988|NCT03994445|Behavioral|Mobile Phone-Based Intervention|"We propose our intervention based on social cognitive behavior theories and the stages of the change model.
~The program will be carried out using the word Mettle, it will help ex-smokers stay off cigarettes through advices generated to promote the health from religious concepts and culture perspectives ."
15855989|NCT03994432|Behavioral|intervention group|"follow a mediterranean diet and practice a regular aerobic exercise according to the 7-minutes workout model."
15855990|NCT03994419|Procedure|Anaesthesia for surgery|Observational study observing proportion of obese and overweight children attending for surgery. Observing adverse events following general anaesthesia for surgery in obese versus healthy weight children.
15855991|NCT03994406|Drug|CLM2 topical gel|Active topical gel for forehead dermal application
15855992|NCT03994406|Drug|Placebo topical gel|Placebo topical gel for forehead dermal application
15855993|NCT03994393|Drug|Tremelimumab|"During induction, patients will receive 4 cycles of durvalumab 1500mg and tremelimumab 75mg with cisplatin 75mg/m2 (or carboplatin AUC 5 if cisplatin is contra-indicated), and pemetrexed 500mg/m2 via intravenous infusion every 3 weeks.
~Followed immediately by a maintenance phase of durvalumab 1500mg and pemetrexed 500mg/m2 once every 4 weeks via intravenous infusion until disease progression or intolerance."
15855994|NCT03994393|Drug|Durvalumab|"During induction, patients will receive 4 cycles of durvalumab 1500mg and tremelimumab 75mg with cisplatin 75mg/m2 (or carboplatin AUC 5 if cisplatin is contra-indicated), and pemetrexed 500mg/m2 via intravenous infusion every 3 weeks.
~Followed immediately by a maintenance phase of durvalumab 1500mg and pemetrexed 500mg/m2 once every 4 weeks via intravenous infusion until disease progression or intolerance."
15855995|NCT03994380|Drug|RhDNAse Inhalation Solution|rhDNAse 2.5 mg nebulizer daily for 4 weeks
15855996|NCT03994367|Other|High animal protein isolate|Increased dietary protein content from animal protein isolates
15855997|NCT03994367|Other|High animal protein whole food|Increased dietary protein content from animal protein whole food
15855998|NCT03994367|Other|High plant protein isolate|Increased dietary protein content from plant protein isolates
15855999|NCT03994367|Other|High plant protein whole food|Increased dietary protein content from animal protein whole food
15856000|NCT03994354|Procedure|J-P drainage and cutaneous penrose drainage insertion|Lots of the stoma wound closure technique have been developed, including subcutaneous antibiotic material implantation, wound irrigation with iodine, closure wound with a drain tube, secondary closure, delayed primary closure and pursestring closure. But there still is in debate about best skin closure test. In Division of Colorectal Surgery Shuang Ho Hospital, two current stoma wound closure methods were subcutaneous Jackson-Pratt drainage and cutaneous penrose drainage insertion.
15856001|NCT03994341|Diagnostic Test|A FLIR Thermovision a320M thermal IR camera|"Clothing removed if necessary
~ECG leads, temperature probes, or transcutaneous monitors will be relocated for abdominal imaging.
~Axillary temperature prior to starting the thermographic imaging.
~Baby's mattress slid out of the isolette and warming bed will be turned off for no more than 60 seconds. This step is necessary since infrared radiation does not pass through the Plexiglas walls of an isolette and the infant's skin surface needs to cool off slightly.
~After surface cooling, thermal imaging will be recorded for ~60 sec to allow for the infrared radiation naturally emitted by the subject's body to be recorded by the infrared camera. The timestamp corresponding to the removal of the heat source will be noted, to indicate the start of the cooling of the abdomen.
~After ~60 seconds of image recording, the recording will stop, the mattress pushed back into isolette.
~Axillary temperature to ensure temperature stability, any clothes will be put back on."
15856002|NCT03994315|Other|B. infantis EVC001|"Bifidobacterium longum subspecies infantis strain EVC001, designated a Foods for Special Dietary Use (FSDU)"
15856003|NCT03994315|Other|Lacto-N-tetraose (LNT)|LNT is a human milk oligosaccharide (HMO) found in human breast milk and is a selective prebiotic for B. infantis.
15856004|NCT03994302|Drug|Drug inducing antiphospholipid syndrome|Drugs susceptible to induce immune toxicities such as antiphospholipid syndrome
15856005|NCT03994289|Behavioral|Motor-assisted cycling|Participants will perform the motor-assisted cycling exercise using a physical therapy bike (RECK; Betzenweiler, Germany). Participants will perform 3×10-min bouts of motor-assisted cycling at the highest tolerable cadence. Before each bout, participants will perform 1-2 minutes of motor-assisted cycling at 5-10 rpm as a warm-up.
15856006|NCT03994289|Behavioral|FES cycling|"The testing procedures will be identical to that in the motor-assisted cycling visit except for the exercise type. Participants will wear FES cuffs on the upper and lower legs, bilaterally.
~. The FES cycling will be performed on the motor-assisted bike using the wearable FES equipment. The purpose of motor-assisted cycling is to provide constant cadence. The Bioness L300 Plus system (Bioness, Valencia, CA) will be worn on the upper and lower legs to stimulates the quadriceps and dorsiflexors muscles during the motor-driven cycling exercise. An embedded gyroscope of the cuff can detect the motion of the lower leg so that the electrical stimulations will be generated at appropriate timing to activate leg muscles during the cycling exercise."
15856007|NCT03994276|Dietary Supplement|Chickpea powder|Chickpea powder is produce using novel production techniques to maintain chickpea cell structure. It will be incorporated into a drink (Dextrose control), or baked into bread rolls at 30% or 60% substitution of wheat flour(100% Wheat flour control).
15856008|NCT03994263|Device|ITind device implant|device implanted for 5-7 days
15856011|NCT03994237|Other|semi-structured interview|The tool used is a nurse card: there is no validated tool on the expectations of the caregiver in his memory referral. This is a pragmatic and practical questionnaire memory consultation request and domestic life with few items, practical use by telephone.
15856012|NCT03994211|Drug|pamiparib (28 day cycles)|60 mg administered orally twice daily/ 28day cycles
15856013|NCT03994211|Drug|pamiparib 60 mg|single dose of 60 mg pamiparib orally in the fasted state (at least 8 hours predose)
15856014|NCT03994211|Drug|pamiparib 20 mg|single dose of 20 mg pamiparib orally in the fasted state (at least 8 hours predose)
15856015|NCT03994211|Drug|itraconazole|200 mg itraconazole once a day approximately 30 minutes after completing a meal
15856016|NCT03994211|Drug|rifampin|600 mg rifampin once a day in the fasted state (at least 2 hours predose)
15856017|NCT03994198|Dietary Supplement|Alpha-lactalbumin|A protein fraction of whey protein, higher in tryptophan
15856018|NCT03994198|Dietary Supplement|Collagen peptides|Collagen peptides from bovine sources
15856019|NCT03994185|Device|Placement of WRAPSODY stent graft|Placement of WRAPSODY stent graft into the iliac arteries and/or aortic bifurcation.
15856020|NCT03994172|Drug|Teriparatide or human parathyroid hormone (PTH) 1-34|Teriparatide or PTH 1-34 is a 34 amino acid peptide derived by recombinant DNA technology from the authentic sequence of human parathyroid hormone. It is given by subcutaneous injection in the dosage of 20 micrograms per day in the trial in both treatment arms for the 48 weeks or 11 months of the trial.
15856021|NCT03994172|Drug|Cinacalcet|This drug is an orally active calcimimetic (drug that activates Ca-sensing receptors on target cells) that will be given daily orally to the men randomized to the Experimental Treatment Arm (#1). Cinacalcet tablets will be given simultaneously with the injection of PTH(1-34) or teriparatide. Cinacalcet will be given only once daily but given every single day of the trial starting with the Randomization Visit for the duration of 48 weeks or 11 months of the trial.
15856022|NCT03994172|Drug|placebo tablet|The placebo tablet in the trial will be purchased from Consolidated Midland Corporation in Brewster, NY. Each white tablet contains Lactose, Stearic Acid and Magnesium Stearate (330 mg total). Subjects randomized to the placebo arm or Placebo - Arm #2 - will take one tablet orally at the same time as he injects the teriparatide each day. Placebo tablets will be given only once daily but given every single day of the trial starting with the Randomization Visit for the duration of 48 weeks or 11 months of the trial.
15856023|NCT03994172|Dietary Supplement|Calcium citrate tablet|Ca citrate supplements (forms 200 or 250 mg elemental Ca/oral tablet) will be used in the study. Each subject will have average dietary Ca intake quantified by a Food Frequency Questionaire. Each subject will take sufficient Ca citrate supplements to make the total Ca intake equal ~1000 mg per day (diet+supplements). Ca supplements will be spread out during the day so that any amount of supplements over 500 mg will be taken at 2 different time-points. Ca citrate supplements will be sourced by our research pharmacist will be of high-quality and consistency. Ca supplements will be started at Screening Visit 2 and given for a 4-week run-in period. Once subjects are randomized to Arm 1 or Arm 2 of the trial, subjects will continue to take daily Ca supplements at the same dose and times as during the run-in period. That daily dosing will continue from day of Randomization through the end of 48 weeks or 11 months of the trial.
15856024|NCT03994172|Dietary Supplement|Vitamin D3|Subjects will be given 1000 IU vitamin D3 in tablet form to be taken orally once a day at any time during the day. Vitamin D3 supplements will be sourced by our research pharmacist and supplements selected for use in the trial will be of high quality and consistency. Vitamin D3 supplements will be started at Screening Visit 2 in the trial and given for a 4-week run-in period. Once subjects are randomized to Arm 1 or Arm 2 of the trial, subjects will continue to take daily vitamin D3 supplements at the same dose and timing as during the run-in period. That daily dosing will continue from the day of Randomization Visit through to the end of the 48 weeks or 11 months of the trial.
15856025|NCT03994159|Device|"Use of the PARO emotional robot"|PARO is an advanced interactive therapeutic robot designed to stimulate patients with Dementia, Alzheimer's, and other cognition disorders.
15856026|NCT03994146|Drug|Remifentanil|"Syringe containing 40 ml of Remifentanil 50 µg/ml for intravenous administration.
~In order to maintain double blinding two identical syringes, prepared by pharmacy according to randomisation, will be simultaneously infused. One of the syringes will be abruptly stopped at the end of the operation whilst the other is tapered by stepwise decreases in infusion rate prior to the end of surgery."
15856027|NCT03994146|Drug|Sodium Chloride 9mg/mL|"Syringe containing 40 ml of Sodium Chloride 9 mg/ml for intravenous administration.
~In order to maintain double blinding two identical syringes, prepared by pharmacy according to randomisation, will be simultaneously infused. One of the syringes will be abruptly stopped at the end of the operation whilst the other is tapered by stepwise decreases in infusion rate prior to the end of surgery."
15856028|NCT03994133|Other|Measurement of the hydration state by bio-impedance spectroscopy|"The measurements will be performed in each center by a reference physician or nurse, using a portable whole body bioimpedance spectroscopy device, BCM (Fresenius Medical Care).
~The electrodes will be attached to one hand and one foot on the ipsilateral side, after the patient has been in the supine position for at least 5 minutes.
~The measurement will be done in pre-dialytic"
15856029|NCT03994120|Other|RTMS|Altering the connectivity of trans-synaptic pathways
15856030|NCT03994107|Drug|Pegylated Liposomal Doxorubicin|"First phase PLD: 30mg/m2；35mg/m2；40mg/m2；IV, d1, q21d×6.
~Second phase
~PLD：MTD. IV, d1, q21d×6."
15856031|NCT03994107|Drug|Albumin-bound paclitaxel|220mg/m2 IV for the first infusion，Subsequent infusions 260mg/m2,if no serious adverse reactions occur. d1, q21d×6.
15856032|NCT03994107|Drug|Trastuzumab|8mg/kg IV for the first infusion. Subsequent infusions 6mg/kg. d1, q21d×6.
15856033|NCT03994094|Other|Telephone interview|Structured, directive, telephone interview, in order to collect the outcome measures in addition to the patients electronic health record.
15856034|NCT03994081|Device|tACS|XCSITE100
15856035|NCT03994081|Device|Sham tACS|XCSITE100
15856036|NCT03994068|Diagnostic Test|VIVO non invasive mapping|non invasive pre-procedural localization of PVC / VT origin
15856037|NCT03994055|Other|Omega-3 fatty acids|Diet will include foods rich in omega-3 fatty acids.
15856038|NCT03994055|Other|Antioxidants|Diet will include foods rich in antioxidant vitamins, trace elements, and polyphenols.
15856039|NCT03994055|Other|Soluble fiber|Diet will include foods rich in soluble fiber.
15856040|NCT03994055|Other|Probiotics|Diet will include foods rich in probiotics.
15856041|NCT03994055|Other|Lactose restriction|Diet will be restricted to 5g lactose/day
15856042|NCT03994055|Other|Fiber restriction|Diet will be restricted to 20g fiber/day
15856043|NCT03994055|Other|Fat restriction|Diet will be restricted to 20% total energy intake
15856044|NCT03994042|Device|Mental imagery neurofeedback training|Mental Imagery (MI)-neurofeedback training, 2-3 hours, 3 times/week for 4 weeks.
15856045|NCT03994029|Dietary Supplement|Effect of polyphenols on hepatic steatosis and vascular elastography and intima media thickness|Measurement of effect of polyphenol supplementation vs placebo on hepatic steatosis and vascular elastography and intima media thickness
15856046|NCT03994016|Behavioral|WiseGuyz|"The WiseGuyz program was developed by the Centre for Sexuality (Calgary, AB), and aims to reduce male-perpetrated adolescent dating violence, improve mental and sexual health, and support youth to build healthier, more inclusive relationships in their peer groups, schools and communities, by helping participants identify and deconstruct gender role norms.
~WiseGuyz is offered during instructional time by community-based facilitators from the Centre for Sexuality. WiseGuyz is comprised of 20 sessions across four modules. These sessions typically take the full school year (September-May) to implement."
15856047|NCT03993990|Behavioral|individual empowerment-based intervention|Participants will receive an empowerment-based intervention individually, based on five steps (i. e. problem identification, meaning and perception clarification, intervention planning, intervention delivery, and evaluation). After the principal investigator delivers a pre-discharge assessment (i. e. the self-care behavior and self-efficacy of diabetes and diabetic foot ulcer, risk factors of foot ulcer, family support, and threat belief of participant), the plan of behavioral modification will be determined by the principal investigator and participants. The subsequent follow-up and intensifying interventions will be delivered at the following time points: three days after discharge, every weeks for one month, every two weeks for subsequent two months, and then every three months for three times.
15856048|NCT03993977|Diagnostic Test|Rotational thromboelastometry|ROTEM-guided protocol of hemostatic resuscitation
15856049|NCT03993977|Other|Conventional treatment|Clinical judgement and conventional coagulation tests
15856050|NCT03993964|Drug|Pyrotinib combine with SHR6390|SHR6390 is a novel small molecule inhibitor specifically targeting the CDK4/6 pathway. Pyrotinib is an irreversible pan-ErbB inhibitor which shows promising antitumour activity in patients with HER2-positive metastatic breast cancer
15856051|NCT03993951|Device|ICT System|Update the Information and Communications Technology System in Family Service Agencies
15856052|NCT03993938|Device|PVI measurement|Masimo Radical-7® probe to be attached to patient's finger along with standard ASA monitors at the start of procedure. After placement of arterial line, stroke volume variation (SVV) and pulse pressure variation (PPV) to be recorded along with pleth variability index (PVI) every 5 minutes. Intraprocedure left atrial pressure (LAP) (v-wave and mean) to be recorded prior to and after MitraClip deployment. Data to be analyzed - age, sex, BMI; Preprocedure ejection fraction (EF), pulmonary artery pressure (PAP), rhythm, mitral regurgitation severity; heart rate, systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) every 5 minutes; SVV, PPV, PVI every 5 minutes; LAP prior to mitraclip deployment; LAP after mitraclip deployment
15856053|NCT03993912|Drug|Daratumumab SC in combination with Lenalidomide|"Daratumumab SC 1800 mg
~once every week for 8 weeks
~then once every other week for 16 weeks
~thereafter once every 4 weeks, until progression"
15856054|NCT03993912|Drug|Lenalidomide PO (25mg)|Lenalidomide PO (25mg): days 1 through 21 of each 28-day cycle, until progression
15856055|NCT03993912|Drug|Dexamethasone PO (20mg): days 1, 8, 15, 22 of each 28-day cycle, until progression|Dexamethasone PO (20mg): days 1, 8, 15, 22 of each 28-day cycle, until progression
15856056|NCT03993899|Device|FineHearing strategy or HDCIS strategy|Cochlear implant with FineHearing strategy or HDCIS strategy
15856057|NCT03993886|Device|CorBand|The CorBand device is a wrist-worn biosensor measuring heart rate, heart rate variability, respiration rate, skin temperature, bioimpedance, and activity.
15856058|NCT03993886|Other|Activity Monitor|commercially available accelerometer to be worn on wrist
15856059|NCT03993886|Other|Bioimpedance spectrometer|Commercially available bioimpedance monitor.
15856060|NCT03993886|Other|ECG|Commercially available electrocardiogram machine
15856061|NCT03993886|Other|respiratory rate sensor|Commercially available respiratory rate sensor.
15856062|NCT03993873|Drug|TPX-0022|Oral TPX-0022 tablets
15856063|NCT03993860|Dietary Supplement|Fish Powder|Dry small fish (Chisense) is roasted and ground into a powder and packed in a sachet (12g) and given to the child at 6 months up to the time the child is 12 moths old. Each month the childs anthropometric measurement are taken to monitor growth.
15856064|NCT03993860|Dietary Supplement|Sorghum powder|Dry sorghum is roasted and ground into a powder and packed in a sachet (12g) and given to the child at 6 months up to the time the child is 12 moths old. Each month the childs anthropometric measurement are taken to monitor growth.
15856065|NCT03993821|Drug|Burosumab|Burosumab, the investigational product, is a recombinant human IgG1 monoclonal antibody targeting FGF23. It is supplied as a sterile, clear, colorless and preservative-free solution and is administered via subcutaneous injection.
15856066|NCT03993808|Behavioral|Revision of congregate meal menus and recipes to align with parameters of DASH eating plan|On a programmatic level, congregate meal menus and recipes have been adapted to align with DASH eating. The changes, which include the introduction of additional servings of fruits, vegetables, seeds, grains, replacement of simple or processed carbohydrates with healthier alternatives, introduction of more fish, reduction in added salt, and replacement of animal fats and butter with olive oil, will be phased-in in stages over 6 weeks, concurrent with the start up the study's educational programs addressing nutrition, BP, and medication adherence. The fully DASH-aligned menus will begin by week 7. The dietary intervention affects all seniors eating congregate meals at the center, not only those enrolled in this protocol to study the impact of DASH implementation.
15856067|NCT03993808|Behavioral|On-site blood pressure monitoring|At baseline (Month 0), and at Months 1, 3, and 6 after the full implementation of the DASH aligned congregate meals, participants will have blood pressure measured by professionals, on-site at the senior center, following established standard procedures. They will receive verbal and written information about their blood pressure results, and encouragement to share the results with their providers.
15856228|NCT03992482|Drug|Intravenous Immune Globulin (IVIG)|Intravenous Immunoglobulin (IVIG), 4 mg/ml (0.4%) eye drops two times a day for eight weeks
15856068|NCT03993808|Behavioral|Home self blood pressure monitoring|Provision of personal Omron 10 home blood pressure monitoring device, training in proper use, and schedule for home self monitoring of BP over the course of the study.
15856069|NCT03993808|Behavioral|Medical adherence education|One required educational session with the community pharmacist to learn about medication adherence strategies
15856070|NCT03993808|Behavioral|Nutrition Education|One required educational session to review the elements of the DASH eating plan, how to overcome barriers to healthy eating, recipes, cooking demonstrations and materials for household members.
15856071|NCT03993795|Other|A19010-W|A snus product
15856072|NCT03993795|Other|B19010-F|A snus product
15856073|NCT03993782|Other|A19010-R|A snus product
15856074|NCT03993782|Other|B19010-O|A snus product
15856075|NCT03993769|Other|A19010-F|A snus product
15856076|NCT03993769|Other|B19010-F|A snus product
15856077|NCT03993743|Biological|CD147-CART|Three infusions of CD147-CART cells over the course of three weeks into the hepatic artery.
15856078|NCT03993730|Device|ICD|Insertion of ICD in patients with LVEF <45% and LGE on CMR.
15856079|NCT03993730|Device|ILR|Insertion of ILR in patients with LVEF <45% and LGE on CMR.
15856080|NCT03993717|Biological|SHINGRIX|A single intramuscular injection of the FDA-approved recombinant glycoprotein E herpes zoster (HZ/su) vaccine will be administered in the deltoid muscle of the preferred arm
15856081|NCT03993704|Drug|LHF-535|Oral suspension administered once daily for 14 days
15856082|NCT03993691|Device|Tomo-E scan|High-resolution limited-angle tomography positioning and examination will vary depending on injury.
15856083|NCT03993691|Device|Radiograph|Standard of Care radiographic imaging of wrist.
15856084|NCT03993678|Drug|IP-001|Dose and route: Immediately (within 15 - 30 min) after thermal ablation, IP-001 will be injected in and around the ablated lesion. The amount of IP-001 injected depends on the dose level.
15856085|NCT03993678|Device|Thermal Ablation|"The medical device includes a laser unit. The system continuously measures the temperature of the tissue, guiding the user to perform precise and safe treatments.
~Treatment time: 30 min"
15856086|NCT03993652|Behavioral|Kids FIRST|family- and school-based intervention to reduce unhealthy screen-time and snacking
15856087|NCT03993639|Drug|Pegfilgrastim|Single dose of SC administration
15856088|NCT03993626|Drug|CXD101 in Combination With Nivolumab|HDAC inhibitor in combination with anti-PD-1 monoclonal antibody
15856089|NCT03993613|Biological|human apotransferrin|Intravenous infusions
15856090|NCT03993600|Diagnostic Test|Sweat test (Macroduct Sweat Collection System) and skin biopsy (Punch Biopsy)|"three groups:
~Healthy volunteers
~Patients with Cystic fibrosis
~Heterozygous subjects"
15856091|NCT03993587|Other|Ultrasound assessment of vessels|Subclavian vein and related structures are examined using ultrasonography
15856092|NCT03993574|Other|Self- management program|"The program sessions are either adapted from the Stanford Patient Education Research Center's program called the Chronic Disease Self-Management Program (CDSMP) or from a vision self-management program.
~Despite which self-management program, the format for each session will include, review of educational materials (using the CDSMP book/article), discussion via a case vignette (which is always stroke related), and participation in an activity based on that session's topic. These group sessions will be 1.5 hours each week for 6 weeks"
15856093|NCT03993574|Other|Standard care|"All stroke patients being discharged from the acute hospital receive the following care:
~1 follow-up call within 2 weeks by a nurse coordinator. The call involves checking if medications were able to be filled and how the person is feeling.
~A stroke clinic appointment that is set to occur 90-days post discharge.
~A list of their personal medications and generic educational materials. The educational materials are standard forms located in the Epic system. It is the nurses' responsibility to choose what forms to provide, however it is mandatory that stroke risk factor information is included.
~Information on local support groups.
~Referrals to start physical, occupational or speech therapy, if recommended by their physician."
15856094|NCT03993561|Other|Treatment summary and survivorship care plan|Individually tailored counselling session will be implemented within 1 month of treatment completion.
15856095|NCT03993548|Behavioral|Wellness Element 1 - Exercise|Daily wellness element focusing on Exercise; adherence documented online daily
15856096|NCT03993548|Behavioral|Wellness Element 2 - Mindfulness|Daily wellness element focusing on Mindfulness Meditation; adherence documented online daily
15856097|NCT03993548|Behavioral|Wellness Element 3 - Sleep Hygiene|Daily wellness element focusing on sleep hygiene; adherence documented online daily
15856098|NCT03993548|Behavioral|Wellness Element 4 - Social Connectedness|Daily wellness element focusing on Social Connectedness; adherence documented online daily
15856099|NCT03993548|Behavioral|Wellness Element 5 - Nutrition|Daily wellness element focusing on Nutrition; adherence documented online daily
15856100|NCT03993548|Behavioral|Wellness Element 6 - Wellness Exercises|Daily wellness workbook exercises focusing on improving mental wellness; adherence documented online daily
15856101|NCT03993548|Behavioral|Wellness Element 7 - Motivational Messages|Daily motivational emails offering information on one of the 5 wellness elements each day (Exercise, Mindfulness Meditation, Sleep, Social Connectedness, and Nutrition)
15856102|NCT03993535|Drug|selective serotonin reuptake inhibitor|open treatment based on patient preference and treatment availability
15856103|NCT03993522|Other|Symptom limited cardiopulmonary exercise test & Sub-maximal cardiopulmonary exercise test|Exercise tests on cycle ergometer for the purpose of collecting expired breath gasses
15856104|NCT03993509|Device|rTMS to the right dlPFC|A Magventure MagPro 100X stimulator with a B65 active/placebo figure-8 coil will be used. The TMS coil will be placed on the head over the target. rTMS intensity will be 100% of the motor threshold (MT), adjusted for field strength difference at motor cortex and target cortex using the individual E-field model. Subjects will receive 3000 pulses/session.
15856144|NCT03993210|Device|Magnetic Resonance Imaging Machine (MRI)|MRI is routinely used in gynecologic malignancies for its ability to depict the extent of disease at diagnosis providing guidance in staging and treatment planning.
15856171|NCT03992937|Drug|Vaginal Micronized Progesterone|Micronized progesterone tablets at a dose of 200 mg once a day vaginally, for 12 days (Between 14'th-25'th days of the menstrual cycle) over three months.
15856172|NCT03992937|Device|Levonorgestrel-Intrauterine System|Release rate of 20µg Levonorgestrel (Mirena-Intrauterine system) per day.
15856105|NCT03993496|Diagnostic Test|Abdominal Aortic Aneurysm Sac Pulsatility|"Measurements of aortic wall pulsatility will be performed using trans-abdominal ultrasound through the non-sterile field of the upper abdomen, while the surgeons operate through the groins. The pulsatilty of the aneurysm will then be measured using transverse views in 'M-Mode' of the ultrasound, and measures the aneurysm wall displacement during a cardiac cycle; the minimum diameter (diastole) and maximum diameter (systole) will be measured. These measurements will occur during surgery:
~Prior to EVAR deployment
~After EVAR deployment, but before balloon affixation to the aortic wall
~After EVAR deployment and after affixation"
15856106|NCT03993483|Behavioral|Unilateral resistance exercise|The participants performed three sets of their unilateral resistance exercise (biceps curls and knee extensions) three times per week for 10 weeks.
15856107|NCT03993470|Behavioral|Short foot excercise for intrinsec muscles of the foot|to examine the effects of the SFE compared to a placebo exercise in the foot posture index after a daily period of 4 weeks.
15856108|NCT03993457|Drug|Escitalopram|Escitalopram will be started at 5 mg/day during the first week of treatment. The dose will then be increased to 10mg/day, and can be increased to 20 mg/day. Dose can be decreased to 5 mg by clinician discretion such as to increase tolerability or better manage side-effects. 5 mg will be the lowest dose allowed in the study.
15856109|NCT03993457|Drug|Bupropion|Bupropion-XL will be started at 150 mg/day and increased to 300 mg/day after one week. This dose can be increased to 450 mg/day (divided in 2 doses) at Week 2 or later. Clinicians may opt to titrate bupropion-XL in a slower fashion in cases that might increase tolerability or better manage side-effects. 150 mg will be the lowest dose allowed in the study.
15856110|NCT03993444|Behavioral|communication and problem solving|a program for supervisors and employees including skills training, validating communication, problem solving
15856111|NCT03993444|Behavioral|psychoeducation|lecture/course for supervisors and employees on risk factors and actions for people experiencing stress and/or pain
15856112|NCT03993431|Drug|Bio-active cement|A cement used for crown cementation, specially recommended for pediatric esthetic crowns
15856113|NCT03993431|Drug|Packable glass ionomer|Glass ionomer cement with improved mechanical properties usually used for restoration of simple small cavities and in Atraumatic Restorative Treatment
15856114|NCT03993418|Dietary Supplement|stevia|This arm will be required to consume 5 stevia drops twice daily in habitual drinks
15856115|NCT03993405|Other|Ultrasonographic evaluation|Ultrasonographic measurement is assessment method to diagnosis of sarcopenia
15856116|NCT03993392|Drug|TM buprenorphine|4mg TM buprenorphine, investigator choice as to brand
15856117|NCT03993392|Drug|SUBLOCADE|300mg subcutaneous injection
15856118|NCT03993379|Drug|CX-072|CX-072 in combination with ipilimumab
15856119|NCT03993379|Drug|Ipilimumab|CX-072 in combination with ipilimumab
15856120|NCT03993366|Combination Product|Fiasp+Pramlintide Closed-Loop System|Closed-loop insulin delivery with Fiasp insulin and pramlintide
15856121|NCT03993366|Device|Fiasp Closed-Loop System|Closed-loop insulin delivery with Fiasp insulin alone
15856122|NCT03993353|Drug|Pembrolizumab|200 mg intravenously every 3 weeks
15856123|NCT03993353|Drug|Tadalafil|10 mg by mouth daily
15856124|NCT03993340|Device|Rescue stenting|The subjects will receive endovascular treatment for acute stroke according to standard clinical practice. Specifically, modern endovascular thrombectomy using a stent retriever, contact aspiration thrombectomy, or both are allowed. The number of thrombectomy attempts is at the operator's discretion. After failure of standard thrombectomy procedure, rescue stenting with Solitaire will be done. Additional balloon angioplasty, glycoprotein IIb/IIIa inhibitor (GPI), or thrombolytic infusions are optional and at the operator's discretion. After successful recanalization with rescue stenting, intravenous maintenance of GPI at least for a 12 hours and then changed to oral antiplatelet are recommended.
15856125|NCT03993327|Biological|Iodine I 124 Monoclonal Antibody M5A|Given IV
15856126|NCT03993327|Procedure|Positron Emission Tomography|Undergo PET scan
15856127|NCT03993314|Drug|Chloroprocaine|Adding 5 cc 1% Chloroprocaine with 10 cc sterile saline in the epidural
15856128|NCT03993314|Drug|Bupivacaine|1 cc of 0.5% bupivacaine with 15 mcg fentanyl 10 cc of sterile saline in the epidural
15856129|NCT03993301|Other|Probiotic A formula|Feeding baby two meals a day with Infant formula with probiotics (10^8 colony-forming unit per day) at least.
15856130|NCT03993301|Other|Probiotic B formula|Feeding baby two meals a day with Infant formula with probiotics (10^8 colony-forming unit per day) at least.
15856131|NCT03993301|Other|Regular formula|Feeding baby two meals a day with regular formula at least.
15856132|NCT03993288|Drug|Ferrum Lek® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Lek d.d., Slovenia)|Participants received Ferrum Lek® 2 tablets daily (200 mg) for 12 weeks
15856133|NCT03993288|Drug|MALTOFER® (iron (III) hydroxide polymaltosate), 100 mg chewable tablets (Vifor S.A., Switzerland)|Participants received MALTOFER® 2 tablets daily (200 mg) for 12 weeks
15856134|NCT03993275|Device|MindMotion GO|Patients will train trunk control and balance using the MindMotion GO device 2-3 times a week. They will perform exergames in sitting or standing, according to their balance level.
15856135|NCT03993262|Drug|Bortezomib|1 to 3 cycles Bortezomib with 1,3mg/m2 body surface s.c. + 20mg dexamethasone p.o. on days 1, 4, 8 and 11 (= 1 cycle)
15856136|NCT03993262|Drug|Placebo|1 to 3 cycles placebo (NaCl solution) s.c. + 20mg dexamethasone p.o. on days 1, 4, 8 and 11 (= 1 cycle)
15856137|NCT03993249|Biological|Nivolumab|standard of care chemoradiotherapy + Nivolumab
15856138|NCT03993249|Other|chemoradiotherapy|standard of care chemoradiotherapy
15856139|NCT03993236|Drug|Experimental: Rosuvastatin/Ezetimibe 10|"Rosuvastatin/Ezetimibe 10/10mg
~orally administered once daily for 90 days"
15856140|NCT03993236|Drug|Active Comparator: Rosuvastatin 20mg|"Rosuvastatin 20mg
~orally administered once daily for 90 days"
15856141|NCT03993223|Behavioral|Upper trapezius muscle fatigue|Isometric contraction of scapular elevation
15856142|NCT03993210|Device|Magnetic Resonance Fingerprinting (MRF)|In MRF, multiple tissue properties are acquired simultaneously.
15856143|NCT03993210|Device|Q-space Trajectory Imaging (QTI)|By using q-space trajectory encoding and a diffusion tensor distribution model, QTI improves the discrimination of diffusivity, shape, and orientation of diffusion microenvironments and therefore carries major potential for imaging the tumor microenvironment.
15856226|NCT03992508|Procedure|complex decongestive therapy|
15856145|NCT03993197|Behavioral|Psychological and corporal group management|"After inclusion, patient will be divided into groups of 6 or 8 patients either in pre-operative or post-operative phase. Patient care will take place entirely in pre-operative or post-operative phase.
~Each group will benefit of six one hour and a half sessions.
~The frequency is established as follows:
~First week a session of Body Strategy ©
~Second week a psychological session with group of speech (Photolanguage ©).
~Third week is a break Then the cycle currently described is repeated, for a total of 6 alternate sessions"
15856146|NCT03993184|Behavioral|Hot Yoga|Bikram or hot yoga is a standardized series of 26 postures with two breathing exercises. Classes will be performed at local yoga studios in Austin, Texas and participants will be required to sign in for each session. All participants will receive 12 weeks of free classes for their participation.
15856147|NCT03993171|Drug|gold nanocrystals|CNM-Au8 is a dark red/purple-colored liquid formulation consisting of a stable suspension of faceted clean surfaced elemental gold nanocrystals in buffered deionized water with a concentration of up to 0.5 mg/mL of gold. The formulation is buffered by sodium bicarbonate present at a concentration of 0.546 mg/mL. There are no other excipients. The drug product is formulated to be taken orally and will be provided in single dose HDPE containers. The study doses vary by the concentration of gold nanocrystals per milliliter in a volume of 60 mL.
15856148|NCT03993145|Behavioral|Web-based lifestyle intervention|Lifestyle intervention program including educational modules on diet and physical activity with visual and audio. Phone conversation with the clinical dietician at week 1, week 3, week 6, week 12 and month 6 (completion of the study).
15856149|NCT03993132|Drug|Empagliflozin|new users (initiators) of Empagliflozin
15856150|NCT03993132|Drug|Liraglutide|initiators of Liraglutide
15856151|NCT03993119|Drug|Non-vitamin K antagonist oral anticoagulant|Non-vitamin K antagonist oral anticoagulant
15856152|NCT03993106|Drug|sEphB4-HSA|sEphB-HSA may prevent tumor cells from multiplying and blocks several compounds that promote the growth of blood vessels that bring nutrients to the tumor.
15856153|NCT03993093|Other|CD4 cell count|CD4 cell count from treatment naive HIV patients
15856154|NCT03993080|Device|Virtual reality relaxation|1-3.5 minute 360° videos
15856155|NCT03993067|Procedure|Hemopatch|Hemopatch is a collagen based sealant is a hemostat agent. We want to investigate his role in the prevention of post operative biliary fistula
15856156|NCT03993067|Procedure|Fribrin glue and Tabotamp|Fibrin glue and Tabotampis the standard treatment
15856157|NCT03993054|Behavioral|Cognitive behavioral stress management|The SmartManage CBSM intervention includes content that is of clinical relevance to sexual minority men dually diagnosed with HIV and cancer. Intervention content includes: co-management of HIV and cancer, strategies for self-advocacy, partnering with the health system and health providers, intimacy and disclosure concerns regarding both conditions, and contextual stressors (e.g., racial/ethnic minority status), stigmatization, assertiveness and communication skills, and self-efficacy in care coordination. Participants receive weekly 1.5 hour interactive group sessions online that focus on stress and self-management skill-building, and also receive access to didactic information regarding intervention content via the intervention website. Intervention length is 4 weeks.
15856158|NCT03993054|Behavioral|Culturally-tailored cognitive behavioral stress management|This intervention will be a version of SmartManage that is culturally-tailored for Latino populations.
15856159|NCT03993041|Behavioral|Cognitive-behavioral therapy (CBT)|Study therapists will deliver cognitive-behavioral therapy (CBT) based on an emotion-focused, transdiagnostic protocol. CBT targets problematic thoughts, feelings, and behaviors through goal-oriented, systematic procedures. The intervention used in this study is designed to target emotional processing with an emphasis on present-focused awareness, cognitive flexibility, emotional avoidance, awareness and tolerance of physical sensations, and situation-based emotion exposure. The intervention is designed to help individuals better understand emotional experiences in order to respond to intense emotions in a more adaptive way.
15856160|NCT03993015|Other|Help to diagnosis software|Help to diagnosis software
15856161|NCT03993002|Other|Normoxia with Normocarbia|PaO2 < 100 (FiO2 >= 21%) PaCO2 of 30-40
15856162|NCT03993002|Other|Normoxia with Hypercarbia|PaO2 < 100 (FiO2 >= 21%) PaCO2 of 50-60
15856163|NCT03993002|Other|Hyperoxia with Normocarbia|PaO2 > 250 (FiO2 >= 70%) PaCO2 of 30-40
15856164|NCT03993002|Other|Hyperoxia with Hypercarbia|PaO2 > 250 (FiO2 >= 70%) PaCO2 of 50-60
15856165|NCT03992989|Device|Phonak Bolero M90-M|The Phonak Bolero M90-M is a Behind-the-Ear Hearing aid with direct connectivity functionality from Phonak which will be fitted to the participants individual Hearing loss
15856166|NCT03992989|Device|Roger Select|The Roger Select is an accessory which can be connected to a compatible hearing aid. It offers an external microphone which streams signals directly to the connected hearing aid.
15856167|NCT03992976|Other|Online Chronic Pain Management Intervention for Teenagers|The intervention itself is currently under development. This development study is used to gather patient (teenager) insights, as well as insights from parents of these patients, which will inform the content and structure of the proposed intervention. This is done using qualitative-only techniques. Initial ideas for the intervention design mirror current clinical practices in paediatric chronic pain management. There are likely to be several different online modules, which include psychological techniques, medicine (advice), nursing (advice and guidance on non-pharmacological physical pain management), and physiotherapy (guidance for pacing and physiotherapy exercises). The intervention is intended to help teenagers employ a vast range of self-management techniques from these disciplines. Exact content is not yet refined as this is a development study.
15856168|NCT03992963|Device|Hearing Aid without frequency lowering enabled|Each participant will be fitted with frequency lowering disabled. Disabled means standard hearing loss compensation without lowering higher frequencies in lower frequency areas. The input frequency is mapped to the same frequency in output.
15856169|NCT03992963|Device|Hearing Aid with frequency lowering enabled|Each participant will be fitted with frequency lowering enabled. The principle of the frequency lowering algorithm is to lower high frequencies to a lower frequency region with the aim of ensuring high frequency audibility to improve auditory emotion recognition.
15856170|NCT03992950|Other|Maneuvers for occluding esophagus|Cricoid pressure: pressure on the cricoid ring Paratracheal pressure: pressure on the left paratracheal region below the cricoid level
15856227|NCT03992495|Other|Exercise|All participants will be exposed to aerobic/strengthening exercises
15856428|NCT03991039|Radiation|Gamma knife|Microvascular decompression
15856173|NCT03992924|Procedure|function or imaging guided PCI|FFR may be good tools to differentiate patients with STEMI who may not need stent implantation from those who need Optical coherence tomography (OCT) can visualize the microstructure of culprit and the OCT characteristics were validated by histology
15856174|NCT03992911|Drug|Simmtecan, 5-FU and l-LV|Simmtecan was administered intravenously at 80 mg per square meter on day1 with LV 400 mg per square meter administered as a 2-hour infusion, and 5-FU 2400 mg per square meter as a 46-hour infusion on day1 every 2 weeks in one course.
15856175|NCT03992911|Drug|Toripalimab|Toripalimab was administered intravenously at 240 mg on day 1 every 2 weeks in one course.
15856176|NCT03992911|Drug|Etoposide, Cisplatin|Etoposide was administered intravenously at 100 mg per square meter on day 1,2,3 with Cisplatin at 80 mg per square meter on day 1 every 3 weeks in one course.
15856177|NCT03992911|Drug|Etoposide, Carboplatin|Etoposide was administered intravenously at 100 mg per square meter on day 1,2,3 and Carboplatin with AUC 5mg/mL/min on day 1 every 3 weeks in one course.
15856178|NCT03992898|Other|No special intervention was suitable for this observational study|Investegators divided patients into 3 corhort according to the liver condition at enrollment (i.e. chronic liver disease, compemsated cirrhosis, decompensated cirrhosis). All patients received standard medical treatment, including nutritional supplementation; administration of human serum albumin, fresh frozen plasma, antivirus treatment and appropriate treatment for complications. No special intervention was suitable for this observational study.
15856179|NCT03992885|Drug|Icotinib|"Intervention: Drug: Icotinib Ectinib 125mg/ tablet, one tablet at a time, three times a day, take orally
~Intervention: Drug: Carboplatin/ Cisplatin Pemetrexed 500mg/m2, intravenous infusion, day 1;Carboplatin AUC6/ Cisplatin 75mg/m2,intravenous infusion, day 1,21 days for a cycle"
15856180|NCT03992872|Biological|Chikungunya|Virus Like Particle
15856181|NCT03992859|Procedure|Continuous serratus plane block|Peripheral nerve catheter placed by the surgeon at the end of surgery
15856182|NCT03992846|Drug|75 mg linzagolix tablet|For oral administration once daily
15856183|NCT03992846|Drug|200 mg linzagolix tablet|For oral administration once daily
15856184|NCT03992846|Drug|Add-back capsule (E2 1 mg / NETA 0.5 mg)|For oral administration once daily
15856185|NCT03992846|Drug|Placebo tablet to match 75 mg linzagolix tablet|For oral administration once daily
15856186|NCT03992846|Drug|Placebo tablet to match 200 mg linzagolix tablet|For oral administration once daily
15856187|NCT03992846|Drug|Placebo capsule to match Add-back capsule|For oral administration once daily
15856188|NCT03992833|Other|lung cancer screening|"In the first reading, according to the NCCN lung cancer screening guideline, participants with a solid nodule≤ 5 mm in diameter will be referred to undergo follow-up CT 1 year after the baseline. Participants with a solid nodule 6-14 mm will be referred to undergo follow-up thorax CT 3-6 months after the baseline. Participants with a solid nodule ≥ 15 mm will be referred to a multidisciplinary team for clinical investigation.
~The simulated management will be based on the volume of lung nodule and volume doubling time from the second reading, lung nodules will be reclassified according to the reference values from the European volume-based lung nodule management protocol. According to the European volume-based protocol, the solid and part-solid lung nodules will be reclassified into three groups: nodules with a volume < 100 mm3 (negative), nodules with a volume of 100-300 mm3 (indeterminate), and nodules with a volume > 300 mm3 (positive)."
15856189|NCT03992820|Device|TENS machine|"The trial group will have the TENS to the area planned for injection for at least 30 minutes before injection of the local anaesthetic solution.
~Pain perception will be evaluated using two Numeric Pain Rating Scales in the study and control groups- one to assess the pain of needle penetration and the second to assess the pain of local infiltration."
15856190|NCT03992820|Combination Product|EMLA cream|"The control group will have EMLA applied on the site planned for local anaesthetic injection and after 1 hour, will be removed and immediately injected with the same anaesthetic solution (this is already a procedure practised by many of the surgeons).
~Pain perception will be evaluated using two Numeric Pain Rating Scales in the study and control groups- one to assess the pain of needle penetration and the second to assess the pain of local infiltration."
15856191|NCT03992807|Other|A patient decision aid|Potential participants receive a printed decision aid booklet with information about cataract surgery choice, and outcome data will be gathered using standardized questions in a structured interview after 2 weeks and 1 year.
15856192|NCT03992807|Other|A usual education booklet|Potential participants receive a usual booklet about cataract and cataract surgery, and outcome data will be gathered using standardized questions in a structured interview after 2 weeks and 1 year.
15856193|NCT03992794|Diagnostic Test|Measurement of MR-proADM|It is an observational study. The only intervention was the measure of MR-proADM, but no clinical decision was made based on its value, since the physician attending the patient did´n know the value of MR-proADM
15856194|NCT03992755|Drug|LIQ861 Inhaled Treprostinil|LIQ861 bulk powder is generated from a treprostinil/excipient matrix from which particles of precise size and shape are created and filled into a hydroxypropyl methylcellulose (HPMC) capsule (size 3). LIQ861 capsules are provided in capsule strengths of 25 μg, 50 μg, 75 μg and 100 μg treprostinil.
15856195|NCT03992742|Behavioral|Initial phase: personalized instant messaging (PIM)|"intervention Group participants will receive three months of personalized interaction through IM Apps (e.g. WhatsApp, WeChat). Our counsellors will trigger the conversation and encourage the participants to set a quit day. A total of pre-set 26 messages will be sent with the schedule of once daily for 1 week (the week across the quit date), 3 times a week for 4 weeks (2 weeks each before and after the week with quit date) and once a week for remaining 7 weeks. These messages covered generic information about the benefits of quitting, methods to avoid/ manage craving or withdrawal symptoms, and encouragement to quit and use SC services.
~At the end of the initial phase (1-month), complete responders (quitters) will continue to receive PIM (subgroup C). Incomplete responders (smokers) will be randomized to continue PIM (subgroup B) or receive OCI (subgroup A)."
15856196|NCT03992742|Behavioral|Second phase: optional cocktail interventions (OCI)|For incomplete respondents (subgroup A) randomized to OCI, the available intervention options include multi-media messages, active referral plus financial incentive, phone counseling, family/peer support and medications (NRT). Participants will be guided by cessation counsellors at 1-month follow-up telephone survey to choose any combination of OCI based on their preference. If OCI participants cannot be followed up at 1-month, they will receive multi-media messages by default.
15856197|NCT03992742|Behavioral|Initial phase: regular instant messaging (RIM)|"Participants enrolled in the Control Group will receive regular messages via IM services (e.g. WhatsApp, WeChat) since initial contact and until 3-month after baseline with a tapering schedule: 1) Baseline to 4-week (1-month): 2 times/ week (8 in total); 2) 4-week to 12-week (2- & 3-month): 1 time/week (8 in total).
~SC messages will generally include benefits of SC, encouragement on abstinence and use of SC services, tips on avoiding/ handling craving and reminder of participating in telephone follow-up. A reminder to participate in the telephone follow-up will also be sent at 1-, 2-, 3- and 6-month, making up a total of 20 messages.
~At the end of the initial phase (1-month), complete responders (quitters) will continue to receive RIM (subgroup F). Incomplete responders (smokers) will be second randomized to continue RIM (subgroup E) or receive PIM (subgroup D). Those who are unable to follow up at 1-month will be considered as nonresponsive to the intervention."
15856198|NCT03992742|Behavioral|Second phase: personalized instant messaging (PIM)|"For incomplete responders allocated to PIM (subgroup D), participants will receive the same intervention as the Group A delivered at the initial stage. Participants will receive two months of personalized interaction through IM application. Please refer to Intervention Group Initial phase: personalized instant messaging (PIM) for details."
15856199|NCT03992742|Behavioral|AWARD advice|Ask about smoking history, Warn about the high risk of smoking, Advise to quit as soon as possible, Refer to the smoking cessation services, and Do it again (if the smokers refused to set quit date).
15856200|NCT03992742|Behavioral|Warning leaflet|The 2-sided color printed A4 leaflet, which systematically covers the most important messages to motivate smoking cessation
15856201|NCT03992742|Behavioral|Referral card|"The 3-folded Smoking Cessation Services card consists of brief information and highlights of existing smoking cessation services, contact methods, motivation information and strong supporting messages or slogans"
15856202|NCT03992742|Behavioral|COSH booklet|A general smoking cessation self-help booklet
15856203|NCT03992729|Drug|Pregnant women exposed to tildrakizumab|Subjects exposure to tildrakizumab for the treatment of an approved indication, for any number of days, at any dose, and at any time from the first day of the last menstrual period (LMP) up to and including the end of pregnancy
15856204|NCT03992729|Drug|Pregnant women not exposed to tildrakizumab|Subjects diagnosed with a tildrakizumab-approved indication; frequency matched to the exposed group by disease indication, with the indication validated by medical records when possible, and Subjects with no exposure to tildrakizumab at any time in the current pregnancy; may or may not have taken another medication for their disease in the current pregnancy
15856205|NCT03992716|Drug|SmofKabiven® extra Nitrogen|SmofKabiven® extra Nitrogen (Fresenius Kabi) is a sterile, hypertonic emulsion for parenteral nutrition, in a 3-chamber bag containing amino acids, glucose, a lipid emulsion, and electrolytes.
15856206|NCT03992716|Drug|Olimel N9E|Olimel N9E (Baxter) is a sterile, hypertonic emulsion for parenteral nutrition, in a 3-chamber bag containing amino acids, glucose, a lipid emulsion, and electrolytes.
15856207|NCT03992690|Device|Brain-machine Interfaces, Visuo-tactile Feedback and Assisted Locomotion, or the WANR protocol|Training integrating virtual-reality avatar driven by a brain-machine interface, with tactile feedback through patient's forearms, and assisted locomotion, for neurorehabilitation of SCI patients.
15856208|NCT03992690|Device|Training with traditional physiotherapy protocol|Stretching
15856209|NCT03992677|Other|No intervention|No intervention
15856210|NCT03992664|Other|EDUCATION|"The training program will focus on four parameters: cleanliness, hydration, protection from external stimuli, and finally early detection of skin side effects.
~The re-evaluation of the skin as well as the repetition of the questionnaires will be done every week for 4 weeks."
15856211|NCT03992651|Device|Measurements of capnia and tissue oxygenation by optical transcutaneous sensors|Capnia and tissue oxygenation will be measured by optical transcutaneous sensors
15856212|NCT03992638|Procedure|leucocyte and platelet-rich fibrin (L-PRF) in combination with CAF|Completing root coverage by coronally advanced flap technique in combination with L-PRF.
15856213|NCT03992638|Procedure|CAF|Completing root coverage by coronally advanced flap technique alone
15856214|NCT03992625|Device|Deep Brain Stimulation|High frequency electrical stimulation of deep brain nuclei for the treatment of movement disorders
15856215|NCT03992612|Behavioral|CBT for chronic pain|12 group sessions of cognitive behavioral treatment to manage pain
15856216|NCT03992612|Behavioral|MBPM- Mindfulness-Based Pain Management|8 group session of maindfulness-based treatment to management pain
15856217|NCT03992599|Procedure|Laparoscopic modified complete mesocolic excision|First, complete kocherization may be required to clear possible tumor spread if the tumor is infiltrating or adhering to the duodenum or perinephric fat tissue. Second, if the tumor is locally advanced, the entire prerenal soft tissue behind Gerota's fascia may need to be cleared, especially for tumors growing toward the posterior. The third difference of mCME with the conventional CME involves the tailored resection of the mesocolon and ileal mesentery according to tumor location. After identifying the root of the middle colic artery, the site of the vascular ligation depends on the location of the tumor. When the tumor is located in the cecum and ascending colon, only the right branch of the middle colic artery is ligated. If the tumor was present in these latter sites, the root of the middle colic artery is ligated.
15856218|NCT03992586|Other|Wearing pink glasses|Wearing pink-colored lenses
15856219|NCT03992586|Other|Wearing clear glasses|Wearing clear glasses
15856220|NCT03992573|Procedure|CGF application|CGF application into post-operative soft tissue and bone defects
15856221|NCT03992560|Device|Guide CRT Software Prototype|The medical device in the trial is a software programme that allows image fusion of previously acquired MRI images with real-time X-Ray fluoroscopic images in the cardiac catheter laboratory. We are able to use the MRI information to assess the best location to place the left ventricular lead for a CRT device and then superimpose this location onto the real-time X-Ray fluoroscopic images during the left ventricular lead implantation
15856222|NCT03992547|Other|Robot-assisted Gait Training|SUBAR® (CRETEM, Korea) is a wearable robot with a footplate that assists patients to perform voluntary muscle movements. RAGT enables training of automatically programmed normal gait pattern.
15856223|NCT03992534|Combination Product|LACTIN-V|Vaginal supplementation with L. crispatus CTV-05.
15856224|NCT03992521|Genetic|Nucleosome positioning|Stratification of patients based on nucleosome positioning from plasma DNA.
15856225|NCT03992508|Device|intermittent pneumatic compression|
15856229|NCT03992482|Drug|Placebo|Normal Saline Eye Drops (0.9% NaCl) two times a day for eight weeks
15856230|NCT03992469|Drug|BFAHF-2|BFAHF-2 is a 0.55g circular tablet that is easy to swallow with a diameter of 0.44 inches and a thickness of 0.19 inches. The quality, safety and consistency of BFAHF-2 are established per FDA guidance under a botanical drug title. Low dose (maximum of 2 tablets bid) and full dose (maximum of 5 tablets bid). Weight based dosing will ensure an equivalent amount is given to each individual.
15856231|NCT03992469|Drug|Placebo|Placebo tablets made of cornstarch
15856232|NCT03992456|Biological|Panitumumab|Given IV
15856233|NCT03992456|Other|Quality-of-Life Assessment|Ancillary studies
15856234|NCT03992456|Other|Questionnaire Administration|Ancillary studies
15856235|NCT03992456|Drug|Regorafenib|Given PO
15856236|NCT03992456|Drug|Trifluridine and Tipiracil Hydrochloride|Given PO
15856237|NCT03992443|Drug|CUSA-081|Participants received 1 or 2 doses of CUSA-081, 0.70 mg/2 mL, directly into the catheter lumen
15856238|NCT03992430|Drug|Eteplirsen|Solution for intravenous (IV) infusion.
15856239|NCT03992417|Drug|Dupilumab SAR231893 (REGN668)|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous injection"
15856242|NCT03992391|Behavioral|Suicide Prevention Intensive Outpatient Program|participation in a suicide prevention intensive outpatient program
15856243|NCT03992378|Device|Low Level Transcutaneous Vagus Nerve Stimulation|Stimulation of the auricular branch of the vagus nerve at tragus of the external ear delivered by Parasym device.
15856244|NCT03992378|Device|Low Level Transcutaneous Vagus Nerve Stimulation|Stimulation of the ear lobe delivered by Parasym device.
15856245|NCT03992365|Drug|Quiklean® (sodium phosphate monobasic monohydrate, USP, and sodium phosphate dibasic anhydrous, USP)|"The evening before the colonoscopy: Take 4 tablets with 250 ml of clear liquids every 15 minutes for a total of 20 tablets.
~On the day of the colonoscopy: Starting 3-5 hours before the procedure, take 4 tablets with 250 ml of clear liquids every 15 minutes for a total of 12 tablets."
15856246|NCT03992365|Drug|Polyethylene glycol 3350, sodium sulfate anhydrous, sodium bicarbonate, sodium chloride, potassium chloride, aspartame;Bisacodyl|"The day before the colonoscopy: One 5 mg tablet of Dulcolax® will be administered, do not chew or crush the tablet, in the afternoon before the day of colonoscopy. About 4 hours after administration of Dulcolax®, drink the 1000 ml Klean-Prep solution at a rate of 250 ml every 15 minutes.
~On the day of the colonoscopy: Starting 3-5 hours before the procedure, drink the 1000 ml Klean-Prep solution at a rate of 250 ml every 15 minutes."
15856247|NCT03992352|Diagnostic Test|Age 60+ with planned HCT for Hematologic Malignancy|questionnaires, geriatric assessments
15856248|NCT03992339|Drug|ATG-010 60 mg, orally, twice weekly, each 4 week (28-day) a cycle|Enrolled patients will be treated with a fixed dose, 60 mg of ATG-010, orally, twice weekly, each 4 week (28-day) a cycle.
15856249|NCT03992326|Other|TIL|Adoptive transfer of Autologous Tumor-Infiltrating Lymphocytes
15856250|NCT03992326|Drug|Cyclophosphamide|Cyclophosphamide will be administered as an intravenous (IV) infusion for two days.
15856251|NCT03992326|Drug|Fludarabine|Fludarabine will be administered as an intravenous (IV) infusion for five days.
15856252|NCT03992326|Drug|Interleukin-2|After TIL infusion, IL-2 (optional) will be started as a bolus administration every eight hours, for a maximum of eight doses.
15856253|NCT03992326|Other|Radiotherapy|Low-dose irradiation (1Gy) will be administered using tomotherapy to up to 20 measurable tumor lesions once before TIL infusion.
15856254|NCT03992313|Other|Community-based HCV rapid test|HCV rapid tests will be done in the village
15856255|NCT03992313|Other|Facility-based HCV rapid test|HCV rapid tests will be done in the health center
15856256|NCT03992313|Other|Plasmatic HCV viral load|HCV viral load will be done in provincial hospital on plasma using GenXpert
15856257|NCT03992313|Other|DBS HCV viral load|HCV viral load will be done in Phnom Penh by DBS using Omunis kit
15856258|NCT03992300|Device|Clinical adjustment|Accuracy of the framework is checked in the patient mouth by tactile perception, screwing torque, Sheffield test and radiography.
15856259|NCT03992287|Dietary Supplement|Hydrolysed Red Ginseng Extract|10 ml/day, 2.4g/day for 12 weeks
15856260|NCT03992287|Dietary Supplement|Placebo|Placebo for 12 weeks
15856261|NCT03992274|Other|Enhanced implementation of PrEP|During Enhanced Implementation study sites will receive Implementation Support to plan and introduce PrEP by following the eight stages of the PrEP-adapted SIC. Implementation Support specifically will involve a centralized technical assistance system developed using US-based PrEP experience focused on addressing implementation issues identified through real-time analysis of client, clinic, and implementation data.
15856262|NCT03992274|Drug|PrEP|Pre-exposure prophylaxis (PrEP) is a biomedical HIV prevention strategy. A fixed-dose of emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) was approved by the U.S. FDA in 2012.
15856263|NCT03992261|Drug|Halobetasol Topical Foam|Foam
15856264|NCT03992248|Behavioral|Time restricted feeding|Eating within a time frame of 10hrs during the day. Outside of this time frame, participants need to refrain from food and energy containing drinks.
15856265|NCT03992248|Behavioral|Control|Eating for at least 14hrs per day.
15856266|NCT03992235|Other|Chest physiotherapy|"All patients will receive chest physiotherapy including Breathing exercise, intensive spirometry use, coughing, ambulation."
15856267|NCT03992235|Other|Educational material|Exercise brochure with photos and explanations
15856268|NCT03992222|Device|Physical exercise programs PEP targeted on appropriate muscle strengthening devices allows|administration of a Physical exercise program for 24 weeks.The participants will be followed at the 24 and 52nd weeks.
15856269|NCT03992209|Other|Standard care|Usual operating room practice
15856270|NCT03992209|Other|Protocolized care|Hand washing per protocol
15856271|NCT03992196|Drug|Rotigotine 1 mg/24 h|Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 1 mg/24 h (5 cm^2 patch size).
15856566|NCT03989934|Behavioral|Healthy Topics|Health education program for adolescents
15856272|NCT03992196|Drug|Rotigotine 2 mg/24 h|Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 2 mg/24 h (10 cm^2 patch size).
15856273|NCT03992196|Drug|Rotigotine 3 mg/24 h|Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 3 mg/24 h (15 cm^2 patch size).
15856274|NCT03992170|Drug|Daratumumab|Daratumumab is a human monoclonal antibody (mAb) IgG1 that binds to the highly expressed CD38 protein on the surface of multiple myeloma cells and, at various levels, also in other types of cells and tissues. The CD38 protein has multiple functions, such as receptor-mediated adhesion, signal transduction activity and enzymatic activity.
15856275|NCT03992157|Device|ECG telemetry|ECG telemetry (holter ECG) is a portable case - attached to the belt or around the neck - connected to 6 electrodes placed on the skin next to the heart. They are worn by patients during their stay in hospital
15856276|NCT03992144|Drug|Amoxicillin 500 Mg|Amoxicillin 500mg an hour before tooth extraction
15856277|NCT03992144|Drug|metronidazole 400mg|400mg of metronidazole an hour before extraction
15856278|NCT03992144|Drug|metronidazol 400mg and amoxicillin 500mg|400mg metronidazole TDS, amoxicillin 500mg BD for 5 days after extraction
15856279|NCT03992131|Drug|Rucaparib|Oral rucaparib will be administered twice daily
15856280|NCT03992131|Drug|Lucitanib|Oral lucitanib will be administered once daily
15856281|NCT03992131|Drug|Sacituzumab govitecan|IV Sacituzumab govitecan will be administered Days 1 and 8 every 21 days
15856282|NCT03992118|Behavioral|Parent coaching|Parents will be coached to implement behavioural strategies to address factors which are contributing to difficult mealtime behaviours and feeding challenges.
15856283|NCT03992105|Other|prospective cohort|"topics included openly in the Respite Site, made up of the first 50 subjects followed prospectively"
15856284|NCT03992092|Device|C-MAC VS|C-MAC Video Stylet
15856285|NCT03992092|Device|Flexible Bronchoscopy|Flexible Bronchoscopy
15856286|NCT03992079|Procedure|ReCOVER Enhanced Recovery Protocol|The experimental group will receive preemptive pain management before surgery, an opioid-free strategy during surgery, and an opioid-sparing multimodal pain management protocol after surgery.
15856287|NCT03992066|Drug|Vadadustat|oral 150 mg tablet
15856288|NCT03992066|Drug|Darbepoetin alfa|solution intravenous injection
15856289|NCT03992066|Drug|Epoetin alfa|solution for intravenous injection
15856290|NCT03992053|Other|sacroiliac joint injection|Image-guided sacroiliac joint injection under fluoroscopy or CT guidance and the success of intraarticular access was demonstrated by inter-articular contrast spread (the standard of care, not part of study intervention).
15856291|NCT03992027|Behavioral|CF-CBT: A Cognitive-Behavioral Skills-Based Program to Promote Emotional Well-Being for Adults wtih Cystic Fibrosis|CF-CBT is an 8-session program introducing cognitive-behavioral coping skills for managing stress, and for prevention and treatment of anxiety and depression. The content of the program was developed to address stressors related to coping with cystic fibrosis. Participants will receive a patient workbook, and meet with a trained member of the CF team (interventionist) who will guide them through learning and practicing coping skills during 8 weekly sessions.
15856292|NCT03992027|Behavioral|Waitlist Control|Participants receive usual care for 3 months followed by CF-CBT. CF-CBT is an 8-session program introducing cognitive-behavioral coping skills for managing stress, and for prevention and treatment of anxiety and depression. The content of the program was developed to address stressors related to coping with cystic fibrosis. Participants will receive a patient workbook, and meet with a trained member of the CF team (interventionist) who will guide them through learning and practicing coping skills during 8 weekly sessions.
15856293|NCT03992014|Drug|Linerixibat tablet|Linerixibat will be available as white to slightly colored film-coated round tablet to be administered as two tablets taken in the fasted state in the morning with 240 milliliter (mL) of room temperature water.
15856294|NCT03992014|Drug|[14C]-linerixibat intravenous infusion|[14C]-linerixibat will be available as clear, colorless solution free from visible particulates to be administered 25 mL IV over 3 hours immediately after the oral dose.
15856295|NCT03992014|Drug|Linerixibat oral solution|Linerixibat will be available as clear, colorless solution free from visible particulates to be administered 60 mL solution in the fasted state in the morning.
15856296|NCT03992001|Biological|Blood component A|PRBCs obtained from whole blood after separation of plasma, buffy coat, and RBCs and successive leukoreduction of RBCs
15856297|NCT03992001|Biological|Blood component B|PRBCs obtained by leukoreduction of whole blood, and successive separation of plasma and RBCs
15856298|NCT03991988|Drug|Montelukast|"Participants in this arm will take a pill of Montelukast daily on escalating doses: 10, 20 to 40 mg.
~All participants will be initiated on 10 mg. The dose will be increased in 2-week increments to 20 mg and 40 mg as long as participants report no intolerable symptoms or adverse events."
15856299|NCT03991988|Drug|Placebo oral tablet|Participants in this arm will take a matched placebo pill daily
15856300|NCT03991975|Drug|Anlotinib|a multi-target receptor tyrosine kinase inhibitor.
15856301|NCT03991975|Drug|TQB2450|TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
15856302|NCT03991962|Drug|mFOLFIRINOX|Patients will receive 6-12 cycles of mFOLFIRINOX every 2 weeks
15856303|NCT03991962|Radiation|Stereotactic body radiotherapy (SBRT)|Stereotactic body radiotherapy (SBRT) will be delivered to the primary tumor and any adjacent involved lymph nodes to 33 Gy in 5 fractions over the course of 2 weeks, and within 4 weeks of chemotherapy.
15856304|NCT03991949|Other|Experimental Infant Formula|Formula fed Ad libitum
15856305|NCT03991936|Drug|Placebos|Normal saline intralesional injection
15856306|NCT03991936|Drug|Triamcinolone Acetonide 2.5 mg/mL|2.5 mg/mL intralesional injection
15856307|NCT03991936|Drug|Triamcinolone Acetonide 5.0 mg/mL|5.0 mg/mL intralesional injection
15856308|NCT03991936|Drug|Triamcinolone Acetonide 7.5 mg/mL|7.5 mg/mL intralesional injection
15856309|NCT03991936|Drug|Triamcinolone Acetonide 10 mg/mL|10 mg/mL intralesional injection
15856457|NCT03990779|Diagnostic Test|Echocardiography|Echocardiographic examination before and after cardiopulmonary bypass
15856310|NCT03991923|Device|XVIVO heart preservation devices|The intervention is to preserve hearts during transportation cold, cardioplegic and non-ischemic, with a high oncotic and hormone supplemented perfusate.
15856311|NCT03991923|Device|Standard ICSS|Cold static preservation using standard preservation solution
15856312|NCT03991910|Drug|Placebos|the control group will be given placebo inside a capsule, so study participant won't be able to know the drug and doses inside the capsule (for masking). Placebo will be given until 5 days prior to Mitral valve replacement surgery.
15856313|NCT03991910|Drug|Ramipril 5Mg Oral Capsule|the treatment group will be given each Ramipril 2,5 mg inside a capsule as an initial dose, for 2 weeks. If there is no serious adverse effect in the observation period of 2 weeks, Ramipril 5 mg inside a capsule will be given for the next weeks until 5 days before the mitral valve surgery date. Study participant won't be able to know the drug and doses inside the capsule (for masking)
15856314|NCT03991897|Dietary Supplement|Ketogenic diet|Ketocal, a nutritionally complete ready-to-drink liquid, is foreseen to ensure adequate amounts of vitamins and minerals will be used. After 24 weeks a Modified Atkins diet will be started.
15856315|NCT03991897|Dietary Supplement|Isocaloric diet|Patients will follow an isocaloric diet
15856316|NCT03991884|Drug|Etoposide|Given IV
15856317|NCT03991884|Drug|Doxorubicin|Given IV
15856318|NCT03991884|Drug|Vincristine|Given IV
15856319|NCT03991884|Drug|Prednisone|Given PO or IV
15856320|NCT03991884|Drug|Cyclophosphamide|Given IV
15856321|NCT03991884|Biological|Inotuzumab Ozogamicin|Given IV
15856322|NCT03991871|Device|External Counter Pulsation (ECP) therapy|35 hours ECP treatment in 35 sessions
15856323|NCT03991858|Other|Phone call follow-up|A physical therapist made a phone call to the patient one month after his/her initial evaluation at the external rehabilitation clinic
15856324|NCT03991858|Other|Telerehabilitation follow-up|A physical therapist made a direct follow-up through telerehabilitation to the patient one month after his/her initial evaluation at the external rehabilitation clinic
15856325|NCT03991845|Drug|Vit D|Vit D supplementation was done
15856326|NCT03991832|Drug|Olaparib|Olaparib is a drug that blocks a protein called poly (ADP-ribose) polymerase (PARP). PARP is important in the growth and spread of cancer cells. Because of this, blocking PARP from working is expected to stop the growth of or shrink cancer cells.
15856327|NCT03991832|Drug|Durvalumab|Durvalumab is a drug that works by stopping a protein called Programmed Cell Death Ligand 1 (PD-L1) from working. PD-L1 is a protein that is thought to prevent the immune system (the body's defense against diseases) from killing cancer cells. Stopping PD-L1 from working is expected to allow the immune system to once again prevent or slow down cancer growth.
15856328|NCT03991819|Drug|Binimetinib|Binimetinib is a drug that, inside the cell, blocks an important series of chemical reactions called a molecular pathway. Binimetinib blocks the MEK1/2 pathway from working. In some types of cancers, this pathway becomes too active, which can cause tumor cell growth. Blocking the MEK1/2 pathway from working is thought to slow or stop tumor cell growth.
15856329|NCT03991819|Drug|Pembrolizumab|Pembrolizumab is an immunotherapy drug that is approved by Health Canada for the treatment of patients with PD-L1 positive non-small cell lung cancer as a first treatment. PD-1 is a type of protein that binds to another type of protein known as PD-L1. When these proteins bind together, it helps prevent cells from killing each other, including cancer cells. Some drugs, like pembrolizumab, are used to block PD-1 from binding to PD-L1. When the protein is blocked, the body's immune system can kill more cells.
15856330|NCT03991806|Other|Obsservational|The frailty and the health adverse events of older adults will be assessed by using a questionnaire called: Association of Centre of Excellence Self-Administered questionnaire (CESAM).
15856331|NCT03991780|Drug|Fostamatinib|All patients will be given treatment with Fostamatinib. The initial treatment dose will be 100mg of Fostamatinib twice daily for 8 weeks. If after 8 weeks the participant has not experienced any side effects and are tolerant of this dose, then the dose will increase to 150mg twice daily. This dose will continue for the duration of the study.
15856332|NCT03991767|Other|"POP-UP electronic alert"|"Implementation of the POP-UP electronic alert for all patients with eligibility criteria"
15856333|NCT03991767|Diagnostic Test|Serology HIV|Realization of HIV serology for included patients.
15856334|NCT03991754|Procedure|transcatheter aortic valve implantation|transcatheter aortic valve implantation
15856335|NCT03991741|Biological|Autologous Tumor Infiltrating Lymphocytes|Autologous TILs
15856336|NCT03991741|Biological|High-Dose Interleukin 2|720,000 IU/kg every 8 hours for up to 15 doses
15856337|NCT03991715|Behavioral|Activity Tracker|Individually tailored daily and weekly physical activity goals established for all participants. Participants sent weekly reports for 6 weeks after cardiac rehabilitation discharge.
15856338|NCT03991702|Diagnostic Test|diagnostic test|The overall motor function of the patient will be assessed using the Medical Research Council (MRC) scale and Palmar dynamometer strength
15856339|NCT03991689|Behavioral|solution-focused group therapy|Participants began a 90-minute solution-focused pain management group, which lasted for six weeks, and after the group ended, the questionnaire post-test was carried out, and a total of 26 participants thus completed their group journey. The group effect was evaluated by the difference between the scores of the questionnaires before and after the group.
15856340|NCT03991676|Behavioral|Values-Based Behavioral Treatment|The values-based behavioral treatment will consist of a series of three, once-weekly weight loss workshops infused with techniques to elicit values clarification and awareness in moments of dietary decision-making, and to enhance autonomous motivation for behavior change.
15856341|NCT03991650|Behavioral|Monitoring with a device|Participants will be monitored by an App.
15856342|NCT03991637|Device|Non-Invasive Comprehensive Metabolic Panel|The device utilizes spectroscopy and machine learning to detect metabolic analyte concentrations.
15856343|NCT03991624|Diagnostic Test|cognitive assessment|"MMSE : Mini-Mental State Examination
~5 words of Dubois
~Direct Assessment of Functional Status
~Trail Making Test
~BREF : Fast Front End Efficiency Battery
~short battery of praxies
~Quality of Life in Alzheimer's Disease"
15856429|NCT03991026|Behavioral|Healthy food and Education/Cooking Classes|The intervention includes providing weekly seasonal produce and healthy foods to participants in addition to an education/cooking class that will be tailored to Diabetes Mellitus, Type II.
15856567|NCT03989921|Other|no intervention. observational study|no intervention. observational study
15856344|NCT03991624|Other|Inhibition evaluation|"Stroop Victoria : This test consists of 3 sheets of 24 items, organized in 6 lines of 4 (points, neutral words or names of colours), from which the subject must identify the ink of the stimuli as quickly and precisely as possible.
~Stop Signal task on the computer to give a response to the presentation of a target stimulus (Go signal) (e.g. pressing a button when a red circle appears on the screen, but doing nothing when a blue triangle appears), and prevent this response when the stimulus is followed or preceded by a beep (stop signal) (e.g. the appearance of a red circle is immediately preceded or followed by a beep, the subject should not press the button)."
15856345|NCT03991624|Other|Assessment of mental flexibility|"a letter-number pair task. The subject sees 4 blocks of 48 letter-number pairs appear successively on a screen. When the pair appears at the top, the subject must make a parity judgment but when the pair appears at the bottom, the subject must make a consonant / vowel judgment.
~a category change task, which consists in classifying a word according to one category or another according to a visual clue that appears. The task consists of 4 blocks of 48 stimuli."
15856346|NCT03991624|Other|Evaluation of the update|"an update span task for which letters appear on a screen sequentially, and subjects must memorize the last three, without knowing the length of the list. The task will consist of 3 tests of training and then 20 tests. After three errors consecutive, the task ends.
~an n-back task that consists of a sequential presentation of letters, during which the subject must indicate when the stimulus. The task consists of 3 levels, with n = 1, n= 2 or n = 3. For level 1 (with n = 1), the subject must press a button when the same letter appears twice in a row on the screen. This task consists of 75 letters."
15856347|NCT03991624|Other|working memory|"the empan baba task, which mainly involves maintaining information, and which consists in retaining a series of letters, appearing sequentially on a screen, and whose latency time between two word presentations is required for a secondary task: the repetition of baba syllables.
~the task of reading operations which consists in recalling operations series of letters whose presentation is interspersed with the reading aloud of simple operations and of their results.
~the ongoing operational task of recalling a list of letters, the presentation of which is interspersed with operations that are simple to read aloud and to to solve head-on."
15856348|NCT03991624|Other|episodic memory|- A recognition task with a Remember/Know paradigm
15856349|NCT03991611|Other|Administration of the IPREA3 questionnaire|On the day of the ICU discharge, the bedside nurse administers to the patient the 18-item IPREA questionnaire i.e the nurse asks the patient to rate from 0 to 10 the severity of each discomfort source contained in the IPREA3 questionnaire experienced during the entire stay in the ICU
15856350|NCT03991611|Other|Immediate feedback through electronic reminder messages|After the nurse had administered the questionnaire, warning messages are displayed on the screen corresponding to the key points to prevent the three discomforts reported with the highest scores
15856351|NCT03991611|Other|Targeted interventions in each ICU to reduce discomforts|"These targeted interventions are implemented through the coordination of two local champions.
~The central coordination IPREA3 team sends each month to the local champions monthly and cumulative discomfort scores of their unit (overall score of discomfort and scores for each item) and their ranking relative to other units assigned to the interventional arm i.e applying the IPREA3 program.
~The local champions organize monthly meetings with the unit staff to present the results in terms of perceived discomforts measured by the IPREA questionnaire, identify main discomfort sources and actions to be conducted to reduce the discomforts reported with the highest scores in the unit and those that are most easily preventable, and assess the efficacy of already applied measures."
15856352|NCT03991598|Other|Exercise program|Exercise program in communities / Exercise program at home
15856353|NCT03991585|Behavioral|Musical Contour Regulation Facilitation (MCRF)|MCRF involves 20-minute music therapy sessions comprised of seven interconnected components. Each session follows the same contour of neutral, low, and high arousal experiences facilitated through music.
15856354|NCT03991572|Device|repeated transcranial magnetic stimulation with real coil|repeated transcranial magnetic stimulation with real coil is a noninvasive technique to activate and modify the activity of the neurons
15856355|NCT03991572|Device|repeated transcranial magnetic stimulation with sham coil|repeated transcranial magnetic stimulation with sham coil is a placebo
15856356|NCT03991559|Drug|Manganese Chloride|Administered intranasally in Arm 1 (0.05, 0.1 or 0.2 mg/kg/d) and by inhalation in Arm 2 (0.1, 0.2 or 0.4mg/kg/d) once daily in a 3-week cycle
15856357|NCT03991559|Drug|Anti-PD-1 antibody|Administered intravenously, at 2-4mg/kg on day 3 in a 3-week cycle
15856358|NCT03991559|Combination Product|Systemic therapy|Whether and which should be given depends on the treatment regimen before enrollment.
15856359|NCT03991546|Behavioral|Acceptance and Commitment Therapy Delivered via an Automated Mobile Messaging Robot|Mobile messages utilizing the principles of Acceptance and Commitment therapy. These messages were developed in collaboration with a pain psychologist who specializes in treating chronic pain with Acceptance and Commitment therapy. Subjects received twice-daily messages for two weeks following their orthopaedic procedure.
15856360|NCT03991533|Other|multiparametric MRI|preoperative multiparametric MRI
15856361|NCT03991520|Drug|Anakinra 100Mg/0.67Ml Inj Syringe|The study drug is100mg/day Anakinra, which is the standard, FDA approved dose for the treatment of rheumatoid arthritis. The randomized treatment will be self-administered by the subject each evening by subcutaneous injection.
15856362|NCT03991520|Drug|Placebo|The placebo is comparable to the anakinra formulation without the active medication - a solution (pH 6.5) containing anhydrous citric acid (1.29 mg), disodium EDTA (0.12 mg), polysorbate 80 (0.70 mg), and sodium chloride (5.48 mg) in water for injection
15856363|NCT03991494|Drug|[14C]-pamiparib|During the treatment phase, pamiparib 60 mg administered orally twice daily
15856364|NCT03991481|Biological|Cryopreserved platelets|Platelets that have undergone a process to freeze, store and reconstitute platelets, extending their expiry to 2 years
15856365|NCT03991481|Biological|Liquid-stored platelets|Liquid-stored platelets as per standard practice
15856366|NCT03991455|Device|Apyx device|The Apyx device enables approximation and fixation of the vaginal apex to the SSL using a deployable anchoring system.
15856367|NCT03991442|Drug|Fimasartan/Amlodipine|Active Comparator: a fixed dose combination of Fimasartan/Amlodipine or placebo
15856458|NCT03990766|Drug|Theophylline|Theophylline delivered via high-volume, low-pressure nasal saline irrigation
15856459|NCT03990766|Drug|Saline Nasal|Lactose delivered via high-volume, low-pressure nasal saline irrigation
15856368|NCT03991429|Diagnostic Test|Simultaneous functional MRI and urodynamic studies|"Double lumen 7 Fr MRI-compatible catheters will be placed in the bladder and rectum. A Phillips Ingenia 3.0T full body MRI scanner with standard 12 channel head coil will be used. Instructions to communicate using right hand signals representing full urge and voiding or attempt of voiding will be given. Signs will be shown to the patient when filling of the bladder is begun and when filling is stopped. Also, in order to keep our noise-to-signal ratio low, all stimulators including any extra visual stimuli and the UDS machine will be removed from the MRI scanner room. The filling and voiding cycle will be repeated up to 4 times in each patient. Bladder will be aspirated after each voiding. This algorithm will be performed before, and, 3 and 6 months following BOO procedure."
15856369|NCT03991429|Behavioral|Questionnaires|Each patient will provide a detailed history and undergo a complete physical examination. Each patient will have the following assessments: IPSS and Incontinence Severity Index (ISI), Patient Global impression of severity (PGI-S) and improvement (PGI-I), International Index of Erectile Function (IIEF-5), MRI Safety Screening Questionnaire.
15856370|NCT03991429|Other|Post Void Residual (PVR), Uroflow and Bladder Diary|Follow-up assessments: Uroflow and PVR assessment, bladder diary, and all questionnaires will be repeated in all patients at one, three, and six months.
15856371|NCT03991429|Diagnostic Test|Urinalysis|Urine sample
15856372|NCT03991416|Behavioral|Understanding Your Baby|Research-based knowledge on the understanding and meeting of the baby's socioemotional needs is delivered to the parents systematically by public health visitors based on a manual, cue cards, and video clips at four time points from 1 to 10 months postpartum.
15856373|NCT03991416|Behavioral|Postnatal care as usual|In accordance with Danish national guidelines, health visitors visit families during the infants first year of life, where they weigh and measure the infant. Further, they offer individual guidance and support regarding for instance feeding, sleeping, how to stimulate the infant, and the developmental stages that the infant goes through.
15856374|NCT03991403|Drug|Atezolizumab(Tecentriq)|Atezolizumab(1200 mg IV);Over 60 (± 15) min (for the first infusion); 30 (± 10) min for subsequent infusions if tolerated Frequency: Day 1 of every 21 days Induction: Four or Six Cycles Maintenance : until PD
15856375|NCT03991403|Drug|Pemetrexed|"Induction Period (Four or Six Cycles)
~(1) Pemetrexed(500 mg/m2 IV); Over approximately10 minutes on Day 1 q3w
~Maintenance Period (Until PD) Pemetrexed(500 mg/m2 IV); Over approximately10 minutes on Day 1 q3w"
15856376|NCT03991403|Drug|Bevacizumab|Bevacizumab(15 mg/kg IV);Over 90 (±15) min (for the first infusion); shortening to 60 (± 10) then 30 (± 10) min for subsequent infusions if tolerated
15856377|NCT03991403|Drug|Carboplatin|Carboplatin(AUC 5 or 5.5 IV a); Over approximately 15-30 min
15856378|NCT03991403|Drug|Paclitaxel|Paclitaxel(175 mg/m2 IV); Over 3 hours
15856379|NCT03991403|Drug|Carboplatin or cisplatin|Carboplatin(AUC 5.5 IV);Over approximately 30-60 minutes on Day 1 q3W or Cisplatin(75 mg/m²) ; Over 1-2 hours on Day 1 q3w
15856380|NCT03991390|Other|Visual Feedback and Core Stability exercises protocol|"This arm consists of 5 sessions per week, 60 minutes each. One session consists of 30 minutes of conventional physiotherapy and 30 minutes of Core Stability exercises and laser visual feedback exercises, on alternate days.
~All sessions will be performed by the same physiotherapist."
15856381|NCT03991390|Other|Control stroke|"This arm consists of 5 sessions per week, 60 minutes each comprising usual physiotherapy treatment.
~All sessions will be performed by the same physiotherapist."
15856382|NCT03991377|Behavioral|Eye movement desensitization and reprocessing therapy|"EMDR is an integrative psychotherapy that uses standardized protocols and elements of cognitive-behavioral, interpersonal, and body-centered therapies, as well as dual stimulation (e.g., side-to-side eye movements).
~The current standard protocol includes eight phases:
~Patient history.
~Patient preparation.
~Patient assessment.
~Memory desensitization.
~Installing the positive cognition.
~Body scan.
~Closure.
~Reevaluation."
15856383|NCT03991377|Drug|Treatment as usual|Once patients are discharged from hospital, they will be treated by the multidisciplinary team of the Specialized Early Intervention Programme for Incipient Psychosis (PAE-TPI) as part of their usual treatment, which consists of a multidisciplinary approach that includes pharmacological treatment and psychological support, from social workers or nursing staff. An individual care plan is drawn up depending on individual needs and may include follow-up psychiatric visits to evaluate clinical status and, if necessary, readjust pharmacological treatment, and psychological visits to assess and detect risk situations and prevent relapses using a non-trauma focused CBT. In no case will psychological treatment focus on PTSD.
15856384|NCT03991364|Other|Constant gait speed group|The speed of the robot-assisted gait treatment is constantly applied for 5 times a week for 2 weeks.
15856385|NCT03991364|Other|Increasing gait speed group|The speed of the robot-assisted gait treatment is gradually increase for 5 times a week for 2 weeks.
15856386|NCT03991351|Other|Exposure to images|Exposure to images
15856387|NCT03991325|Diagnostic Test|upper airway sonography|clinical evaluation of upper airway, ultrasonographic assessement
15856388|NCT03991312|Drug|itraconazole|Participants will receive an oral solution as described in the arm description.
15856389|NCT03991312|Drug|rifampin|Participants will receive oral capsule(s) as described in the arm description.
15856390|NCT03991312|Drug|mitapivat sulfate|Participants will receive an oral tablet as described in the arm description.
15856391|NCT03991299|Drug|Botox 200 UNT Injection|Botox will be injected into duodenums of subjects by endoscopy.
15856392|NCT03991286|Dietary Supplement|Astaxanthin 8 mg|experimental
15856393|NCT03991286|Other|placebo|Matching placebo pill
15856394|NCT03991273|Other|Y-M2M©|The Y-M2M© group will receive classes that will be delivered onsite at a YMCA facility. Movement-to-Music (M2M©) is an instructor-guided exercise program that is coupled with music to enhance strength, cardiorespiratory capacity, range of motion, and balance.
15856395|NCT03991273|Other|B-M2M©|The B-M2M© group will receive the same onsite M2M© classes as the Y-M2M© group, but they will also be provided with the option of performing home-based M2M© that will be delivered via videoconferencing.
15856396|NCT03991260|Diagnostic Test|SPECT|One single injection of 99mTc- ADAPT6, followed by gamma camera imaging directly post-injection and after 2, 4 and 6 hours.
15856456|NCT03990792|Other|Brief psychoeducational intervention|The intervention consists of an App that weekly send brief psychoeducational messages about physical and mental health (depression, anxiety, sleep hygiene, physical activity, etc.)
15856397|NCT03991247|Behavioral|Computerized behavioral therapy program delivered by internet for insomnia management|"The online program consists in restriction of time in bed and stimulus control instructions.
~First, patient will complete an on-line sleep diary during 2 weeks. The personalized program is then activated by a practitioner (phone interview) who both assesses restriction of time in bed and delivers instructions of stimulus control. Then, restriction of time in bed is administered by the internet-delivered self-help program. The participant still completes his on-line sleep diary every day. Every 7 days, according mean sleep efficiency, a new sleep schedule recommendation is given to the participant. In addition, the program delivers everyday a set of instructions (stimulus control) designed to re-associate the bed/bedroom with sleep and to re-establish a consistent sleep wake schedule. The duration of restriction of time in bed program is 3 weeks (during spa treatment or at home depending on the allocated arm)."
15856398|NCT03991247|Other|Spa treatment|"Spa treatment is harmonized in the different stations. It consists in:
~a medical thermal follow-up: weekly medical consultation of 15 minutes during the 3 weeks spa treatment.
~an institutional follow-up: support, help and monitoring of patients during spa treatment
~Crenotherapy: 18 baths of 10 minutes in running water, 18 spa showers of 3 minutes, 9 massages under water of 20 minutes, 18 baths of 10 minutes in pool. Water temperature of pool is between 31°C and 33°C. Water temperature for other care is 35°C and 38°C."
15856399|NCT03991234|Behavioral|Reading Intervention|Reading intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction to build skill on letter-sound associations, decoding, sight words, & contextualized reading.
15856400|NCT03991234|Behavioral|Math Intervention|Math intervention provides 15 weeks (3 30-minute sessions per week) of explicit instruction on number knowledge & counting strategies to build arithmetic skill.
15856401|NCT03991234|Behavioral|Coordinated Intervention|Coordinated intervention provides 15 weeks (30-minute sessions per week) of explicit instruction addressing the similar skills as in the reading intervention arm & similar objectives as the math intervention arm.
15856402|NCT03991221|Other|Dental Exam|Visual examination of the child oral cavity bi non-orthodontist experts and orthodontist expert
15856403|NCT03991221|Other|Orthodontics consult|Consultation with an orthodontics specialist if a malocclusion requiring early intervention is detected
15856404|NCT03991221|Other|Call back at 6 month|Telephone call back at six months of inclusion in the study if a malocclusion requiring early intervention is detected
15856405|NCT03991208|Drug|Malarone|Malarone
15856406|NCT03991195|Dietary Supplement|Probiotic supplemented intervention|In this project, taking the method of random, double blindness and control, the probiotic supplemented group with aMCI will take Bifidobacterium for three months. After that, cognitive changes will be test to investigate the effectiveness of probiotic supplementation.
15856407|NCT03991195|Dietary Supplement|Placebo|In this project, taking the method of random, double blindness and control, the placebo group with aMCI will take placebo for three months. After that, cognitive changes will be test.
15856408|NCT03991182|Other|SMAGs trained on ECD curriculum|50 volunteers (primarily SMAGs- Safe Motherhood Action Group members) associated with the health facility will be trained using a training -of-trainers approach on the e ECD (early childhood development) curriculum
15856409|NCT03991182|Other|Head women trained on ECD curriculum|Each of the 50 trained SMAGs will train 10 head women on the ECD curriculum
15856410|NCT03991182|Behavioral|Head women led parent groups|Every two weeks 500 trained head women lead parent group meetings on childhood development and nutrition to caregiver-child dyads
15856411|NCT03991182|Other|Usual care of children 0-5 months|The traditional care and education of caregivers/parents for children 0-5 months
15856416|NCT03991143|Drug|ATH3G10|intravenous
15856417|NCT03991143|Drug|Placebo|intravenous
15856418|NCT03991130|Drug|IL-2 and Nivolumab|Course length will be 35 days. Subjects will receive 480 mg IV of nivolumab on day 1 of the cycle. The patient will be admitted to UCSD Jacobs Medical center for standard HD IL-2 which will be administered every 8 hrs for up to 14 doses days 8-12 per institutional practice. The patient will be readmitted days 22-28 for HD IL-2 every 8 hrs for up to 14 doses. Nivolumab 480 mg IV will be administered day 35. Scans for response will occur 4 weeks after day 35 nivolumab dose and response will be determined by RECIST 1.1 to determine if the patient will receive the next course.
15856419|NCT03991117|Behavioral|resistance exercise|unilateral knee extensions until fatigue with varying load and speeds of contraction
15856420|NCT03991104|Drug|Oxaliplatin|Oxaliplatin (3 levels for phase I: 110 mg/m², 120 mg/m² and 130 mg/m²) is administered as a 2 h intravenous infusion in 500 mL of 5% glucose on day 1 and day 29 during the treatment course.
15856421|NCT03991104|Drug|S-1 capsule|Patients received a fixed dose of S-1 with a dose of 80 mg/m2/d twice daily for 2 weeks, every 4 weeks.
15856422|NCT03991104|Radiation|Intensity modulated radiotherapy (IMRT)|The total radiation dose was set to 50.4 Gy, which was given in 28 fractions of 1.8 Gy once-daily fractions for over 5 weeks.
15856423|NCT03991091|Drug|discontinuation of oxytocin administration|Discontinuation of oxytocin administration at the beginning of the active phase of the 1st stage of labor, i.e. oxytocin infusion will be stopped beyond a cervical dilatation of 6cm. In the experimental group, oxytocin can be re-started, if necessary, after 2 hours of arrest of labor.
15856424|NCT03991091|Drug|continuation of oxytocin administration|continuation of oxytocin administration
15856425|NCT03991065|Diagnostic Test|high digestive endoscopy|high digestive endoscopy with biopsies performed according to the sydney protocol
15856426|NCT03991052|Device|EV1000 and closed-loop system|This system will recommend when patients need fluid or not and adjust vasopressor administration automatically by the closed-loop system
15856427|NCT03991052|Device|Control group|This system will recommend when patients need fluid or not and nurses will adjust vasopressor administration as usual (standard of care)
15856430|NCT03991013|Drug|Dolutegravir 50 mg|Tenofovir-lamivudine-dolutegravir fixed-dose combination tablet with a lead-in supplementary dose of 50 mg dolutegravir taken 12 hours later for the first 14 days, with continuation of tenofovir-lamivudine-dolutegravir for the duration of the study (48 weeks).
15856431|NCT03991013|Drug|Placebo|Tenofovir-lamivudine-dolutegravir fixed-dose combination tablet with a matching placebo taken 12 hours later for the first 14 days, with continuation of tenofovir-lamivudine-dolutegravir for the duration of the study (48 weeks).
15856432|NCT03991000|Drug|Ferric carboxymaltose|Intravenous iron
15856433|NCT03991000|Drug|Saline|Saline application according to dosing rules of iron.
15856434|NCT03990987|Other|time of receiving operation|patients were randomly divided into Day group (D group) (8：00～12：00) and Night group (N group) (18：00～22：00), Patients received propofol, remifentanil, and DEX for general anesthesia maintenance
15856435|NCT03990974|Drug|postoperative antimicrobial prophylaxis|The drugs are all common antibiotics used to prevent postoperative infection in each hospital.
15856436|NCT03990974|Other|No postoperative antimicrobial prophylaxis|Patients will receive no antibiotics after hepatectomy unless necessary.
15856437|NCT03990961|Drug|Pembrolizumab|Subjects will receive pembrolizumab treatment at a dose of 200mg IV every 3 weeks for a duration of 2 years (35 cycles).
15856438|NCT03990948|Other|Blood sampling|Blood sample collection
15856439|NCT03990935|Other|ginger and rosemary gel|First the participant will be asked to brush his/her teeth thoroughly with 1450 ppm fluoride toothpaste (Colgate total healthy clean toothpaste). Then an application of a thin ribbon of this gel to the teeth using a brush. The medication will be left for at least 1 minute. The participant will be asked to spit out the medication after use and not to swallow it. Also the participant will be asked not to rinse his/her mouth, eat, or drink for at least 30 minutes after use to get the best results.
15856440|NCT03990922|Procedure|Continuous Paravertebral block with ropivacaine|Inject 25 ml 0.5% ropivacaine in the T8 paravertebral space followed with catheter insertion and continuous 0.2% ropivacaine infusion(infusion rate: 0.125ml/kg/pulse,1pulse/h).
15856441|NCT03990922|Procedure|"Continuous Paravertebral block with saline"|Inject 25 ml 0.9% saline in the T8 paravertebral space followed with catheter insertion and continuous 0.9% ropivacaine infusion(infusion rate: 0.125ml/kg/pulse,1pulse/h).
15856442|NCT03990922|Drug|Patient-controlled analgesia with morphine|Morphine given as intravenous patient-controlled analgesia bolus: 2mg, lock time: 5min, 1h limitation: 8mg
15856443|NCT03990909|Dietary Supplement|Branched Chain Amino Acids|60 grams of BCAA (2:1:1 ratio of Leucine:Isoleucine:Valine) consumed in two doses (30 grams each) mixed into 20 oz of water for up to21days (42 total drinks).
15856444|NCT03990909|Dietary Supplement|Rice Protein|60 grams of rice protein consumed in two doses (30 grams each) mixed into 20 oz of water for up to 21days (42 total drinks).
15856445|NCT03990909|Dietary Supplement|Microcrystalline Cellulose|60 grams of microcrystalline cellulose, consumed in two doses (30 grams each) mixed into 20 oz of water for up to 21days (42 total drinks).
15856446|NCT03990896|Drug|Talazoparib|"Talazoparib is a study drug that inhibits (stops) the normal activity of certain proteins called poly (ADP-ribose) polymerases also called PARPs. PARPs are proteins (made from genes which are part of DNA) that are found in all normal and cancer cells that are involved in the repair of DNA. PARPs are needed to repair mistakes that can happen in DNA when cells divide. If the mistakes are not repaired, the defective cell will usually die and be replaced. Cells with mistakes in their DNA that do not die can become cancer cells."
15856447|NCT03990883|Device|Princess Filler Lidocaine|correction of nasolabial folds
15856448|NCT03990870|Other|dCBGT + WASABI|Participants in the experimental treatment group will complete daily Ecological Momentary Assessments (EMAs), 1 hour of digitally delivered Cognitive Behavioral Group Therapy (dCBGT) per week, and weekly cognitive biases assessments and self-reports for 16 weeks. Participants assigned to this intervention will also have daily access to 1:1 and group chat Instant Messaging (IM) and will have weekly electronic check-ins with study staff (as needed).
15856449|NCT03990870|Other|dCBGT Only|Participants in the active comparator group will be asked to attend 1 hour of digitally delivered Cognitive Behavioral Group Therapy (dCBGT) per week for 16 weeks and weekly electronic check-ins with study staff (as needed).
15856450|NCT03990857|Other|Comprehensive care protocol in new diagnosis of Type 2 Diabetes Mellitus and associated comorbidities in Primary Care|This comprehensive intervention is developed in a structured way in the Primary care nurse office. 5 individual intensive visits will be carried out with a weekly or bi-weekly frequency (according to the learning process) to work for an integral care and to transmit the knowledge and skills required. The maximum time expected to receive this 5 visits is 3 months. At least one of the visits, preferably the one that deals with dietary aspects, the patient is asked to be visited with the partner, child or cohabiting person. The research team elaborated the support material with the minimum contents that every patient that begins with T2DM and other chronic pathologies should know. It allows incorporating cultural and emotional aspects. It was agreed with hospital diabetes educators and family doctors. A graphic designer gave an enticing design. A group of patients verified their utility and intelligibility. It is delivered to the person and discussed during the intensification.
15856451|NCT03990844|Dietary Supplement|Okra seed|Noodle enriched with 10% and 20% Okra seed flour.
15856452|NCT03990831|Diagnostic Test|Functional near-infrared spectroscopy (fNIRS)|Functional near-infrared spectroscopy (fNIRS) measurement
15856453|NCT03990805|Biological|JOINTSTEM|JOINTSTEM Autologous Adipose Tissue derived MSCs 1x10^8cells/(saline), 1 time injection
15856454|NCT03990805|Drug|saline|saline, 1 time injection
15856455|NCT03990792|Behavioral|e-predictD intervention|The intervention is based on validated risk algorithms to predict depression and includes: 1) Mobile applications as main user's interface; 2) a DSS that helps patients to develop their own personalized plans to prevent (PPP) depression; 3) eight intervention modules (the core of the system) including activities to prevent depression, to be proposed by the DSS and chosen by the patient. The intervention is biopsychosocial and multi-component, including the following modules: physical exercise, improving sleep, expanding relationships, problem solving, improving communication skills, assertiveness training, making decisions and managing thoughts. Patients will implement the recommendations and the tool will monitor these actions, offering feedback to improve their PPP at 3, 6 and 9 months. The intervention also includes an initial and single 15-minute face-to-face GP-patient interview.
15856460|NCT03990753|Diagnostic Test|esophagogastroduodenoscopy|standard esophagogastroduodenoscopy
15856461|NCT03990740|Procedure|Corneal sampling|Corneal samples will be taken during corneal transplants for cases and orbital exenterations for controls. The mRNA (messenger ribonucleic acid) will be extracted and a retrotranscription will be made to obtain cDNA (complementary DNA). A qPCR (quantitative polymerase chain reaction) will be able to quantify the expression of alpha-SMA, MMP 1-2-3 and 9, and EMMPRIN.
15856462|NCT03990727|Diagnostic Test|Retina Analysis-mosaic|Fundus retina pattern study
15856463|NCT03990727|Diagnostic Test|Autofluorescence|Fundus reflectance-functionality
15856464|NCT03990727|Diagnostic Test|OCT- 1 micra|Fine tomography fundus retina
15856465|NCT03990727|Procedure|Genotype analysis|Molecular target retina dystrophy analysis
15856466|NCT03990714|Procedure|Right hemicolectomy|It is the resection of the right colon by a tumor and the reconstruction by an ileocolic anastomosis: intracorporeal or extracorporeal
15856467|NCT03990701|Combination Product|11C-Metomidate PET/CT Scan|11C-Metomidate PET/CT imaging at Clinical Imaging Research Centre
15856468|NCT03990688|Drug|AK3280|Active Substance: AK3280, Pharmaceutical Form: Tablet, Route of Administration: Oral
15856469|NCT03990688|Drug|Placebo|Active Substance: Placebo, Pharmaceutical Form: Tablet, Route of Administration: Oral
15856470|NCT03990675|Procedure|FNA, FNB|Endoscopic ultrasound guided fine needle aspiration, Endoscopic ultrasound guided fine needle biopsy
15856471|NCT03990662|Other|Physiotherapy - Manual Therapy|Participants will receive four sessions of manual therapy applied to craniomandibular structures over four weeks. The application of manual therapy aims to decrease pain by treating masticatory muscle trigger points, muscle tightness, and restricted temporomandibular joint movements. Several techniques will be considered, including ventral and caudal anterior glide temporomandibular joint mobilisation, soft tissue interventions for the management of trigger points in masticatory muscles and myofascial induction therapy applied to craniomandibular structures. The structures targeted in the treatment sessions will be the temporomandibular joint, temporal muscles, masseter muscles, medial and lateral pterygoid muscles and suprahyoid muscles.
15856472|NCT03990649|Drug|Soticlestat|Soticlestat tablets
15856473|NCT03990649|Drug|Placebo|Soticlestat matching placebo tablets
15856474|NCT03990636|Drug|Metil 5-aminolevulinate|Scrubbing lip vermillion and applying the medication or placebo that is activated (or not, in case of placebo) with red light.
15856475|NCT03990623|Radiation|Computed Tomography Perfusion Imaging|Undergo perfusion CT
15856476|NCT03990623|Procedure|Liver Biopsy|Undergo liver biopsy
15856477|NCT03990610|Procedure|Mammoplasty|Undergo standard of care breast reconstructive surgery
15856478|NCT03990610|Procedure|Vascularized Lymph Node Transfer|Undergo vascularized lymph node transfer
15856479|NCT03990597|Other|Placebo Administration|Applied topically
15856480|NCT03990597|Other|Questionnaire Administration|Ancillary studies
15856481|NCT03990597|Drug|Wound Dressing Material|Applied StrataXRT topically
15856482|NCT03990584|Procedure|three irrigation activation methods|passive ultrasonic irrigation, sonic irrigation, manual dynamic irrigation
15856483|NCT03990584|Procedure|conventional needle irrigation|conventional needle irrigation
15856484|NCT03990571|Drug|Avelumab|Given IV
15856485|NCT03990571|Drug|Axitinib|Given PO
15856486|NCT03990532|Radiation|treatment group(phase I)|"Dose-escalation plan (phase I)
~Radiotherapy:
~LEVEL 1: dose given at PTV-G will be 58.8Gy/28 fractions； 2.1Gy/per fraction; LEVEL 2: dose given at PTV-G will be 64.4Gy/28 fractions； 2.3Gy/per fraction; LEVEL 3: dose given at PTV-G will be 70Gy/28 fractions； 2.5Gy/per fraction Concurrent chemotherapy: 5-Fu/capecitabine/S-1+DDP or S-1 or Capecitabine"
15856487|NCT03990532|Radiation|treatment group (phase II)|Radiotherapy dose was prescribed according to phase I trial results; Concurrent chemotherapy: 5-Fu/capecitabine/S-1+DDP or S-1 or Capecitabine
15856488|NCT03990519|Drug|JNJ-26366821|Participants will receive sterile solution of JNJ-26366821 subcutaneously (SC).
15856489|NCT03990519|Drug|Placebo|Participants will receive sodium chloride injection as placebo on Day 1.
15856492|NCT03990493|Biological|Dengue Virus-1 #45AZ5 (PV-001-DV)|Intratumoral injection of PV-001-DV (1 injection)
15856493|NCT03990493|Biological|Autologous Monocyte-derived Lysate Pulsed Dendritic Cells (PV-001-DC)|IV Infusion of PV-001-DC (every 3 weeks for total of 4 infusions)
15856494|NCT03990480|Drug|valsartan (160 mg/d)|Group I treated with valsartan (160 mg/d, n = 100)
15856495|NCT03990480|Drug|amlodipine (10 mg/d).|Group II amlodipine (10 mg/d, n = 100).
15856496|NCT03990467|Biological|Plasma dosage of amikacin, piperacillin and tazobactam|Pharmacokinetic (PK) criteria will be used to judge whether the PK parameters of amikacin are predictive of those of piperacillin and tazobactam
15856497|NCT03990454|Drug|SLC-391|SLC-391 is an AXL inhibitor
15856524|NCT03990246|Other|Acid unstable emulsion with liquid droplets|This will be a 250 mL acid unstable beverage emulsion in which the droplets are liquid. It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e. crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart. The emulsion will contain 20 % of the lipid palm olein with 2.5% of the emulsifier sorbitan monostearate (Span60)
15856525|NCT03990233|Drug|BI 765063|mAb antagonist to SIRPα receptor, a myeloid checkpoint inhibitor
15856498|NCT03990441|Device|TENS|TENS application using the TensMed S82 (Enraf Nonius). Current parameters: balanced symmetric biphasic square waveform, continuous stimulation, frequency 80 Hz, pulse duration modulated between 250 and 290 μs, modulation time 5 seconds. Self-adhesive electrodes of 50 x 90 mm applied paravertebrally to 2 cm. of the spinous apophysis. Use of two channels with independent intensity (mA): electrodes of the first channel applied at level T10-L1 and second channel ones at level S2-S4. Maximum intensity without reaching pain, increasing the intensity throughout the application to maintain this level. Start of the intervention when the woman expresses pain. End of the intervention when neuraxial anesthesia is applied (if the woman demands it) or after delivery.
15856499|NCT03990441|Device|TENS Placebo|Same application as Intervention, but using 0,1 mA as fixed intensity on both channels.
15856500|NCT03990428|Behavioral|online surveys|Survey data about supportive care needs, mood, and the experience of IC's finding meaning and purpose in the caregiving experience.
15856501|NCT03990415|Behavioral|Exercise|Exercise is a behavioral intervention, the primary aim of this investigation is to elucidate if strength training is a more effective exercise intervention than walking for the improvement of balance in older adults.
15856502|NCT03990389|Device|Chatbot Intervention|a chatbot will be used to monitor depression severity
15856503|NCT03990376|Other|Radioisotope I-131-labeled albumin|1 mL of radioisotope I-131-labeled albumin x 2
15856504|NCT03990363|Drug|Verinurad|"Study treatments will be titrated in 3 steps for target low dose (3 mg), intermediate dose ( 7.5 mg) and High Dose (12 mg) Verinurad.
~As per Protocol Version 5.0, Patients from 3 mg dose will be switched to 24 mg at visit 9"
15856505|NCT03990363|Drug|Allopurinol|Study treatments will be titrated in 3 steps: Low dose (100 mg), intermediate (200 mg) and High Dose ( 300 mg) Allopurinol
15856506|NCT03990363|Drug|Placebo for Verinurad|Matching Capsule
15856507|NCT03990363|Drug|Placebo for Allopurinol|Matching tablet
15856508|NCT03990350|Other|Fecal Sample Collection|With permission from the parent/guardian, stool collected in a sterile container will be brought within 12 hours of defecation from home or the outpatient clinic to a separate clinical laboratory where feces will be collected through use of FLOQswab brush x 3 (Copan Diagnostics, Murrieta, CA) The swabs will be pre-labeled with a de-identified code reflecting patient number, sample number, and date and the sample will be placed into dry ice then transferred to a -80 degrees Celsius freezer until retrieval by the research staff for transfer to CHOP Microbiome Center.
15856509|NCT03990350|Other|Physical Activity Questionnaire|At the initial encounter the co-investigator Dr. David Garcia, who is a certified Spanish translator will complete the Physical Activity Questionnaire (Physical Activity Questionnaire for Older Children) with the subject and parent.
15856510|NCT03990350|Other|Food Frequency Questionnaire|At the initial encounter the co-investigator Dr. David Garcia, who is a certified Spanish translator will complete the Food Frequency Questionnaire with the subject and parent.
15856511|NCT03990350|Other|24-hour dietary recall diary|At the initial encounter the co-investigator Dr. David Garcia, who is a certified Spanish translator will complete the 24-hour dietary recall diary with the subject and parent.
15856512|NCT03990337|Device|Ultrasound|Ultrasonography of cricoid cartilage.
15856513|NCT03990324|Procedure|Manual stretching|Manual stretching for the upper trapezius and levator scapulae muscle
15856514|NCT03990311|Other|Sodium Restricted Meals|2 meals prepared with 2 g /day sodium restriction and adhering to dietary recommendations for a hemodialysis patients (phosphate and potassium restricted/ high protein content) 2 meals per day for first month of meal provision period followed by 1 meal per month in the second meal of meal provision period
15856515|NCT03990311|Other|Control|Usual Care
15856516|NCT03990298|Diagnostic Test|Awake endoscopy|Awake endoscopic exam will be performed to measure airway size in the retropalatal and retroglossal upper airway regions using different Inspire implant configurations and voltages. The optimal test configuration determined on endoscopy will be tested during a sleep study and compared to the standard-of-care device configuration, with improvements in sleep study outcomes indicating that awake endoscopy is useful during Inspire implant activation.
15856517|NCT03990285|Drug|Axumin, Intravenous Solution|To compare 18F-fluciclovine PET uptake measures in glioblastoma patients with tumor progression versus pseudoprogression
15856518|NCT03990272|Drug|AIT drops|once a day
15856519|NCT03990272|Drug|placebo drops|once a day
15856520|NCT03990259|Other|Running the CSP Mountain Race|The runners completed a 107,6 km mountain race
15856521|NCT03990246|Other|Acid stable emulsion with solid droplets|This will be a 250 mL acid stable beverage emulsion in which the droplets are crystalline. It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e. crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart. The emulsion will contain 20% of the lipid palm stearin with 2.2% of the emulsifier sorbitan monooleate (Tween80)
15856522|NCT03990246|Other|Acid stable emulsion with liquid droplets|This will be a 250 mL acid stable beverage emulsion in which the droplets are liquid. It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e. crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart. The emulsion will contain 20 % of the lipid palm olein with 2.2% of the emulsifier sorbitan monooleate (Tween80)
15856523|NCT03990246|Other|Acid unstable emulsion with solid droplets|This will be a 250 mL acid unstable beverage emulsion in which the droplets are solid. It will have identical similar to the other intervention, i.e. in a set of samples the emulsion lipid droplets are in the liquid state and are either acid stable or unstable and, in the other set of samples they are solid (i.e. crystallized) and are also either acid stable or unstable in the acidic environment of the stomach, and will be introduced at least 7 days apart. The emulsion will contain 20% of the lipid palm stearin with 2.5% of the emulsifier sorbitan monostearate (Span60)
15856526|NCT03990233|Drug|BI 754091|mAb antagonist to PD-1 receptor, a lymphocyte T checkpoint inhibitor
15856564|NCT03989947|Drug|Active BMN 111: Daily subcutaneous injection of 15 ug/kg of BMN 111|Modified recombinant human C-type natriuretic peptide
15856565|NCT03989934|Behavioral|The Mind in Action|Mindfulness program for adolescents
15856527|NCT03990220|Dietary Supplement|Lactobacillus rhamnosus yoba 2012|"Probiotics are defined by the Food and Agricultural Organization (FAO)/WHO as live microorganisms, which when consumed in adequate amounts, confer a health benefit on the host. Lactobacillus rhamnosus GG (LGG) is the most documented probiotic bacteria, with many proven unique characteristics and therewith associated health benefits. No adverse effects of the consumption of LGG in healthy infants have been reported. The Lactobacillus rhamnosus yoba containing yoghurt drink, which is locally produced and subsequently consumed by resource-poor communities in rural Uganda has been described. The strain used in this intervention is a generic variant of LGG, called Lactobacillus rhamnosus yoba 2012. LGG is consumed as part of food all over the world, and is not a drug."
15856528|NCT03990207|Device|PowerSpiral Enteroscopy System|Motorized spiral enteroscopy system
15856529|NCT03990194|Drug|Leuprolide Acetate|Administration of Leptoprol implant every 3 months
15856530|NCT03990181|Dietary Supplement|meal matrix & NPPS|Test meal consumed with the natural polyphenol supplement
15856531|NCT03990181|Dietary Supplement|meal matrix & CS|Test meal consumed with the control supplement
15856532|NCT03990181|Dietary Supplement|no-matrix & NPPS|Test drink consumed with the natural polyphenol supplement
15856533|NCT03990181|Dietary Supplement|no-matrix & CS|Test drink consumed with the control supplement
15856534|NCT03990168|Device|Anodal tDCS|1 mA anodal tDCS positioned over left superior temporal gyrus and the cathode placed over the occipital lobe. The tDCS stimulation will be delivered for 20 minutes on 6 intervention days.
15856535|NCT03990168|Behavioral|fluency intervention/ Delayed Auditory Feedback|Each participant complete three tasks include reading, conversation, and narration. Delayed auditory feedback will be used during these tasks. Each treatment session will take 20 minutes.
15856536|NCT03990168|Device|Sham tDCS|The anodal tDCS positioned over left superior temporal gyrus and the cathode placed over the occipital lobe. The current of sham stimulation will involve 30 seconds of stimulation at the beginning of the 20 minutes on 6 intervention days.
15856537|NCT03990155|Procedure|HFNCOT+ECCO2R|NIV will be discontinued, the ECCO2R setting will be unchanged (both sweep gas flow and blood flow through the artificial lung) and HFNCOT will be started, titrating the fraction of inspired Oxygen (FiO2) to obtain an oxygen saturation at periphery (SpO2) 88-92%; HFNCOT start temperature will be 31°C, the initial flow rate will be 60 L/min.
15856538|NCT03990142|Diagnostic Test|Cutaneous conductance to chlorine by SUDOSCAN|"The additional examination, related to this research protocol, corresponds to a record of cutaneous conductance with chlorine. This recording of 2 min 30 is done thanks to SUDOSCAN® within 30 minutes before the dialysis session (before the connection to the dialysis machine) and within 30 minutes after the end of the dialysis with a measurement of the tension blood pressure and heart rate immediately before SUDOSCAN®."
15856539|NCT03990129|Drug|Metamizole|One week treatment with metamizole (500 mg tablets, 2-2-2)
15856540|NCT03990116|Procedure|Lateral|Posture lateral kangaroo care
15856541|NCT03990116|Procedure|Prone|Posture prone kangaroo care
15856542|NCT03990103|Drug|S1|80-120 mg/day, PO, D1-14, every 21 days
15856543|NCT03990103|Drug|Paclitaxel|20 mg/m2/day, IP, D1-3; 50 mg/m2, IV, D1; 70 mg/m2, IV, D8; every 21 days
15856544|NCT03990103|Drug|Bevacizumab|200 mg, IP, D1, every 21 days
15856545|NCT03990103|Drug|Oxaliplatin|130 mg/m2, IV, D1, every 21 days
15856546|NCT03990090|Drug|TG103|Administered SC
15856547|NCT03990090|Drug|Placebo|Administered SC
15856548|NCT03990077|Drug|HL-085|HL-085 ( Capsule) is one MEK inhibitor.
15856549|NCT03990077|Drug|Docetaxel|Docetaxel is an antineoplastic drug by inhibiting microtubule depolymerization, and attenuating of the effects of bcl-2 and bcl-xL gene expression.
15856550|NCT03990064|Other|musicotherapy|receptive music therapy. The musical style of the session was chosen by the patient. The validated 'U' technique was employed.
15856551|NCT03990051|Drug|Pro-ocular™ topical gel|Topical gel for forehead dermal application
15856552|NCT03990051|Drug|Placebo topical gel|Topical gel for forehead dermal application
15856553|NCT03990038|Drug|Continuous perineural infusion of ropivacaine 0.2% 5 ml/h for 48 h|Group C receive the intervention Group U receives the placebo See arm description
15856554|NCT03990038|Drug|Extended Release Capsule|"Group C receives a placebo for extended release hydromorphone Group U receives Hydromorph Contin 3 mg PO BID
~See arm description"
15856555|NCT03990025|Diagnostic Test|Linked Color Imaging|Linked Color Imaging (LCI) is a form of image enhanced endoscopy that uses a laser endoscopic system that acquires images by simultaneously using narrow-band wavelength light and white light in an appropriate balance. This enhances slight color differences in the red region of the mucosa.
15856556|NCT03990025|Diagnostic Test|White Light Imaging|White Light Imaging (WLI) uses conventional white light that encompasses all bandwidths of light to illuminate areas of interest to obtain endoscopic images.
15856557|NCT03990012|Procedure|IR Imaging|Subjects will undergo steady steady state and video IR imaging of the breasts.
15856558|NCT03990012|Procedure|3D Scanning|Subjects will undergo 3D scanning of the breasts.
15856559|NCT03989999|Procedure|Transcranial Doppler (TCD)|"In the Emergency Department (ED):
~After the initial cerebral CT scan, the patient will be included in the study when he/she satisfies inclusion criteria. TCD will be performed within 8 hours of the brain injury.
~If TCD is normal (FVd>25 cm/sec and PI <1.25), the patient will return home under third-party supervision. An advice sheet will be given to the patient according to the SFMU guidelines and another one will be sent to the general practitioner. If initial cerebral CT scan is performed early (< 4-6 hours after TBI), CT scan should not be controlled before patient discharge.
~If the TCD is abnormal (FVd≤25 cm/sec or PI ≥ 1.25) the patient will be hospitalized. There is no recommendation regarding the type of hospitalization (ICU or standard ward).
~No other diagnostic procedure is allowed in the ED (S-100 protein dosing is not allowed). All therapies recommended by the SFMU for mild TBI are allowed in this group."
15856560|NCT03989986|Behavioral|iPeer2Peer Mentorship|Mentors and participants can have up to ten Skype calls over the course of 15 weeks.
15856561|NCT03989973|Diagnostic Test|Gastroscopy|Gastroscopy
15856562|NCT03989960|Procedure|LISA+SNIPPV|The LISA+SNIPPV group receives PS by the way of invasive surfactant administration technique and selects nasal synchronized intermittent positive pressure ventilation.
15856563|NCT03989960|Procedure|traditional InSurE|The traditional InSurE group receives intubation-surfactant- extubation technique and selects CPAP ventilation.
15856568|NCT03989908|Other|Microfludic noodle|In this intervention arm, subjects will be served with noodles made using microfludic technology.
15856569|NCT03989908|Other|Control noodle|In this intervention arm, subjects will be served with normal noodle.
15856570|NCT03989895|Biological|Dengue Virus-1 #45AZ5 (PV-001-DV)|Intratumoral injection of PV-001-DV
15856571|NCT03989882|Other|Wheat germ energy ball|wheat germ mixed other ingredients to make an energy ball
15856572|NCT03989882|Other|Control|corresponding control without wheat germ
15856573|NCT03989869|Other|Immediate treatment|Early Medical Abortion treatment, when ultrasound does not yet have conclusive signs of intrauterine pregnancy
15856574|NCT03989856|Device|2-0 polyglican absorbable sutures|The sutures will be performed with intracorporeal knots using 2-0 polyglican absorbable sutures (Vicryl; Ethicon Inc., New Jersey, USA). Suture is performed using needle holders for the closure of ovarian parenchyma and controlling bleeding. Bleeding from ovarian hilus will only resolve by suturing.
15856575|NCT03989856|Device|Diathermy|bipolar coagulation technique will be used to control significant bleeding (40 W current; Richard Wolf, Germany). I
15856576|NCT03989830|Drug|second-line chemotherapy|choose appropriate regimen according to efficacy and adverse effects of first-line chemotherapy. q3W regimen, 6 cycles.
15856577|NCT03989830|Drug|Recombinant human endostatin|7.5mg/m2/d，continuous intravenous pumping in 2ml/h for 5 days each cycle. Endostar(d-7) begins one week before chemotherapy(d0), first 5-day-pump(d-7 to d-2, 240ml, 2ml/h). Second 5-day-pump begins two days later (d1 to d5). the rest pumps can be done in the same manner. Three 5-day-pumps can be done during one chemotherapy cycle. Endostar will be pumped 18 weeks during 6 cycles'second-line chemotherapy.
15856578|NCT03989817|Drug|Vasoactive Intestinal Peptide (VIP) and Saline|12 healthy volunteers of both genders will be included in the main study. Participants will meet twice, with at least one week in between. The main study is a double-blind, randomized, cross-over trial among placebo (sterile saline, non-active substance) and VIP. Intravenous infusion of VIP / placebo (saline) will be conducted over 120 minutes. Patients will be asked after each trial day to record headache strength, accompanying symptoms, and drug use for up to 24 post-infusion.
15856579|NCT03989804|Behavioral|Targeted follow-up|2 phone calls and 1 e-mail delivered over 6-8 weeks after enrollment aiming to help and support members to get started using the fitness center and its services.
15856580|NCT03989791|Dietary Supplement|absolute diet|Patients in absolute diet group were fasted from any food with intravenous infusion of 5% glucose and sodium chloride instead in the first 24 hours. Then, the patients will be given soup for the next 24 hours if there was no delayed complication or discomfort during the fasting. Finally, they will gradually transit from soup to normal diet such as porridge, noodles and rice in the third 24 hours.
15856581|NCT03989791|Dietary Supplement|normal diet|Patients in normal diet group were directly given normal diet such as porridge, noodles and rice as usual after polypectomy. Meanwhile, all the patients in two groups were given PPI for 3 days intravenously and restricted from vigorous exercise for 14 days.
15856582|NCT03989778|Drug|Vitamin D|Vitamin D supplementation
15856583|NCT03989765|Other|Programme to reduce involuntary treatment episodes|See description of trial arms
15856584|NCT03989752|Device|Wearable Robotic Exoskeleton for Ambulation|16-week walking program (34 sessions) with an overground walking robotic exoskeleton guided by a certified physical therapist
15856585|NCT03989739|Device|Da Vinci|
15856586|NCT03989726|Procedure|AF ablation|AF ablation includes pulmonary vein isolation and/or voltage and fractionation guided ablation
15856587|NCT03989713|Drug|MRD-triggered arm|"Salvage therapy:
~Quizartinib: 40mg, p.o., Days: 4 - 21 Cytarabine: 18-60yrs: 3g/m² bid / >-60yrs: 1g/m² bid, i.v. 3h i.v. 3h, Days: 1,2,3; Mitoxantrone: 10mg, i.v. 30min: Days: 2,3;
~Consolidation therapy:
~Cytarabine: 18-60yrs: 3g/m² bid, i.v. 3h / >-60yrs: 1g/m² bid, i.v. 3h, Days: 1,2,3; Mitoxantrone: 10mg, i.v. 30min, Days: 2,3
~Observation therapy:
~No treatment"
15856588|NCT03989713|Drug|Prophylactic Arm|"Salvage therapy:
~Quizartinib: 40mg, p.o., Days: 4 - 21 Cytarabine: 18-60yrs: 3g/m² bid / >-60yrs: 1g/m² bid, i.v. 3h i.v. 3h, Days: 1,2,3; Mitoxantrone: 10mg, i.v. 30min: Days: 2,3;
~Consolidation therapy:
~Quizartinib: 40mg, p.o., Days: 4 - 21 Cytarabine: 18-60yrs: 3g/m² bid, i.v. 3h / >-60yrs: 1g/m² bid, i.v. 3h, Days: 1,2,3; Mitoxantrone: 10mg, i.v. 30min, Days: 2,3;
~Maintenance therapy:
~Quizartinib: Cycle 1, Days 1-15: 40mg, p.o. and Day 16-28: 60mg, p.o."
15856589|NCT03989700|Drug|Thiamine Mononitrate|Low dose group: thaimine mononitrate 25 mg/day per oral daily for 4 weeks High dose group: thaimine mononitrate 50 mg/day per oral daily for 4 weeks Placebo group: placebo 25 mg/day per oral daily for 4 weeks
15856590|NCT03989687|Device|Fuji Triage|glass ionomer sealant
15856591|NCT03989687|Other|isolation|rubber dam or cotton roll isolation
15856592|NCT03989674|Dietary Supplement|Anthocyanin|25% w/w anthocyanin extract obtained from black rice
15856593|NCT03989648|Other|Esmarch bandages|Esmarch bandage (also known as Esmarch's bandage for surgical haemostasis or Esmarch's tourniquet) in its modern form is a narrow (5 to 10 cm wide) soft rubber bandage that is used to expel venous blood from a limb (exsanguinate) that has had its arterial supply cut off by a tourniquet.
15856594|NCT03989648|Other|simple leg elevation|simple leg elevation 45 degree for 2 minutes is used to expel venous blood from a limb
15856595|NCT03989635|Drug|QAW039|QAW039 450mg
15856596|NCT03989622|Other|evaluation of the visual field on the ground|evaluation of the visual field on the ground
15856597|NCT03989609|Drug|Dexmedetomidine Injection [Precedex]|Dexmedetomidine infusion will be started at 0.1 µg.kg-1.hr-1 and will be adjusted by 0.1 µg.kg-1.h-1 to a maximum of 0.5 µg/kg/h,
15856598|NCT03989609|Drug|Midazolam|midazolam will be started at 1 mg.h-1 (3 mL.hr-1) and adjusted by 1 mg.h-1 to a maximum of 5 mg.h-1 (15 mL.h-1).
15856599|NCT03989596|Radiation|Hypofractionated radiotherapy|"Preoperative hypofractionated 10x 3.25 Gy radiotherapy (5 consecutive days in a week, two weeks) prescribed on planned target volume (tumor volume + elective margins + setup/error margin) with daily image guidance with cone beam-CT or kV-portal position verification.
~Radiotherapy boost 4x 4 Gy within one week in case of unresectability after 6 weeks."
15856600|NCT03989596|Other|Hyperthermia|Deep hyperthermia (Celsius TCS or BSD-2000) according to local protocol combined with radiotherapy, twice a week.
15856601|NCT03989583|Other|Infrared thermography|Temperature observation in foot and footwear in healthy children
15856645|NCT03989336|Drug|Sintilimab|Administered intravenously, 200mg on day 3 in a 3-week cycle (day 2 without Manganese priming)
15856602|NCT03989570|Procedure|transversus abdominis plane block|The TAP block will be performed laterally behind the midaxillary line between the iliac crest and the most inferior extent of the ribs. The plane between the internal oblique and transversus abdominis muscle will be located around the midaxillary line with the probe transverse to the abdomen. Anteriorly,The needle will be passed to come in plane with the ultrasound beam and placed between transversus and internal oblique posterior to the midaxillary line then, the local anesthetic will be injected
15856603|NCT03989570|Procedure|erector spinae plane block|The ESP block will be performed into a fascial plane between the deep surface of erector spinae muscle and the transverse processes
15856604|NCT03989570|Other|control group|placebo
15856605|NCT03989557|Drug|Aspirin and clopidogrel/Ticagrelor|The modification of aspirin and clopidogrel/ticagrelor maintenance doses based on a biomarker assays.
15856606|NCT03989557|Device|Light transmittance aggregometry|point-of-care method to assess platelet function by light transmittance aggregometry.
15856607|NCT03989557|Drug|Aspirin and clopidogrel/Ticagrelor|maintenance dose of aspirin, clopidogrel and ticagrelor.
15856608|NCT03989544|Biological|Tezepelumab|Tezepelumab subcutaneous injection
15856609|NCT03989531|Biological|Adrecizumab|Drip infusion over 60 minutes
15856610|NCT03989531|Drug|Placebo|Drip infusion over 60 minutes
15856611|NCT03989518|Behavioral|Fear acquisition|Day 1. Participants are exposed to two different visual stimuli. One of these stimuli is paired with a mild electric shock (i.e. conditioned stimuli).
15856612|NCT03989518|Behavioral|Imaginal extinction|Day 2 (24 hours after Day 1). Participants are exposed to mental imagery of the stimuli used during fear conditioning. Imagery is prompted through different verbal instructions presented in a pseudo-randomized order. No shocks are delivered. Prior to imaginal extinction, participants receive task specific training.
15856613|NCT03989518|Behavioral|Reinstatement|Day 3 (48 h after day1). Participants are exposed to the same stimuli used during fear conditioning (day 1) and imaginal extinction (day 2). Two unsignaled shocks are delivered at the beginning of the experiment, prior to the presentation of the first visual stimulus. No further shocks are delivered. This procedure allows the study of long term effects of imaginal extinction.
15856614|NCT03989505|Diagnostic Test|blood-draw for biomarker analyses|Blood will be drawn at three time-points: immediately before catherization, 12-24 hours after catheterization and 4-8 weeks after discharge. Creatinine will be measured for endpoint definition, while the markers urea, CRP (C-reactive protein), NGAL (neutrophil gelatinase-associated lipocalin), KIM-1 (kidney injury marker-1), cystatin C, suPAR (soluble urokinase-type plasminogen activator receptor), and penKid will be measured as biomarkers of interest.
15856615|NCT03989492|Other|systemic and local stressors|Protocol 1: skin sympathetic nerve activity will be measured during mental math and handgrip exercise. Protocol 2: skin end organ responses will be measured at baseline and in response to systemic stressors and end-organ receptor stimulation. Protocol 3: skin end organ responses will be measured at baseline and during local heating.
15856616|NCT03989479|Behavioral|Brushing demonstration using T shaped toothbrush|Brushing demonstration given at baseline and reinforced at 2 weeks and 1 month
15856617|NCT03989479|Behavioral|Brushing demonstration using conventional toothbrush|Brushing demonstration given at baseline and reinforced at 2 weeks and 1 month
15856618|NCT03989466|Biological|Alemtuzumab|Given IV
15856619|NCT03989466|Drug|Itacitinib|Given PO
15856620|NCT03989453|Other|Chi Kung|The duration of the intervention is 12 weeks, with 2 sessions per week of Chi Kung. Each session lasts approximately 1 hour and is structured in three parts: initial warm-up (Based on breathing and concentration exercises), of 10 minutes duration, a 40-45 minute Chi Kung session and finally 10 minutes of guided relaxation.
15856623|NCT03989427|Other|Brushing first and Flossing later (BF)|Participants will follow Brushing first and flossing later (BF) sequence for 2 weeks, and after 1 week wash out period, Flossing first and Brushing later (FB) sequence for another 2 weeks.
15856624|NCT03989427|Other|Flossing first and Brushing later (FB)|Participants will follow Flossing first and Brushing later (FB) sequence for 2 weeks, and after 1 week wash out period, Brushing first and flossing later (BF) sequence for another 2 weeks.
15856625|NCT03989414|Drug|CC-92480|CC-92480
15856626|NCT03989414|Drug|Bortezomib|Bortezomib
15856627|NCT03989414|Drug|Dexamethasone|Dexamethasone
15856628|NCT03989414|Drug|Daratumumab|Daratumumab
15856629|NCT03989414|Drug|Carfilzomib|Carfilzomib
15856630|NCT03989414|Drug|Elotuzumab|Elotuzumab
15856631|NCT03989414|Drug|Isatuximab|Isatuximab
15856632|NCT03989414|Drug|Carfilzomib|Carfilzomib
15856633|NCT03989401|Other|Multimedia video health education|The experimental group conducted multimedia video education while admission.
15856634|NCT03989388|Behavioral|Occupational self-analysis|"The Occupational Self-Analysis program provides participants with a space where they can learn to analyse the barriers and supports for occupational participation."
15856635|NCT03989388|Behavioral|Vocational guidance|To explore participant´s job interests and learned how to find a job and define a professional profile.
15856636|NCT03989388|Behavioral|Usual Rehabilitation|Usual rehabilitation: occupational therapy and/or physiotherapy.
15856637|NCT03989375|Device|transcutaneous vagus nerve electric stimulator|The stimulator that can be attached to ears of the patient.We suppose that this device can reduce the incidence of perioperative neurocognitive disorders(PND)
15856638|NCT03989362|Drug|Vopratelimab|Specified dose on specified days
15856639|NCT03989362|Drug|Ipilimumab|Specified dose on specified days
15856640|NCT03989349|Drug|Placebo|Placebo
15856641|NCT03989349|Drug|Nemolizumab|Nemolizumab
15856642|NCT03989336|Drug|Manganese Chloride|Administered by inhalation at 0.4mg/kg twice per week in the first 3-week cycle, and then inhaled 0.4mg/kg twice in the first week of each 3-week cycle thereafter
15856643|NCT03989336|Drug|nab-paclitaxel|Administered intravenously, 180-220mg/m2 on day 2 in a 3-week cycle (day 1 without Manganese priming)
15856644|NCT03989336|Drug|Platinum chemotherapy|Administered intravenously, Cisplatin (60-80mg/m2) or Carboplatin (area under the curve [AUC] 4-6 mg/mL per min) on day 2 in a 3-week cycle (day 1 without Manganese priming)
15864035|NCT03929692|Behavioral|Multi-layer health promotion program|
15856646|NCT03989323|Other|Estimation of the incidence of the irAE|Assessment of the incidence of the irAE in patients treated with immunotherapy at the Hospices Civils de Lyon (irAE of all grades and from all organs) and creation of a biological collection of blood, plasma, serum and PBMCs from patients before treatment, under treatment and at the onset of irAEs.
15856647|NCT03989310|Drug|Manganese Chloride|Administered by inhalation at 0.4mg/kg twice per week in a 3-week cycle
15856648|NCT03989310|Drug|nab-paclitaxel|Administered intravenously, 200mg/d on day 1 and day 8 in a 3-week cycle
15856649|NCT03989310|Drug|Gemcitabine|Administered intravenously, 1g/m2/d on day1 and day8 in a 3-week cycle
15856650|NCT03989310|Drug|anti-PD-1 antibody|Administered intravenously, 2-4mg/kg on day 2 in a 3-week cycle
15856651|NCT03989297|Radiation|Radiation|Consecutive patients who were pathologically diagnosed with NPC and treated with radiation at the Kiang Wu Hospital.
15856652|NCT03989284|Behavioral|Community-based depression interventions|We conducted three types of community-based depression interventions such as peer counseling, social engagement, and combination.
15856653|NCT03989271|Drug|Quercetin|Placebo
15856654|NCT03989258|Diagnostic Test|Mammography outside official screening|Radiologic study
15856657|NCT03989219|Procedure|plasma cfDNA methylation|plasma cfDNA will be performed in patients with pulmonary nodules (0.5-3 cm) found by CT scanning. Evaluation of benign and malignant diagnostic efficacy of cfDNA methylation in pulmonary nodules with clear pathological findings. Pulmonary nodules that could not or temporarily not require invasive examination will be performed CT follow-up and dynamically monitored methylation changes of cfDNA.
15856659|NCT03989193|Device|Computer guided alveolar ridge splitting technique|"The bone splitting technique could be performed using the piezoelectric system, calibrating the device on D1 setting and using profuse saline irrigation. The preparation sequence begins with CS3 insert until a total depth of 10mm was achieved across the entire extension of the ridge. The procedure continued with the CS1 insert and finally the CS2 insert.
~The vertical bone cuts through the cortical layer: At the distal end of the horizontal split, a vertical cut will made with the high-speed bur within the vicinity of the buccal plate to start the separation, with a full vertical depth of 13 mm. Final design of the splitting cut was L-shaped split. At the distal and the mesial end of the horizontal split, a vertical cut was made with the high-speed bur for a full vertical depth of 13mm."
15856660|NCT03989180|Device|C-Scan System|"Subjects will receive detailed instructions (verbally and written) about the normal operation of the recorder and how to handle it during normal daily routine. They will be asked to document all their daily activity in a personal diary (attached)
~The recorder will be secured to their lower back to test its functionality"
15856661|NCT03989167|Other|Clinical decision support|Computer-based support tool for identification of patients with high levels of total cholesterol or LDL-C, at high risk of being affected by FH.
15856662|NCT03989141|Procedure|Repeated cannulation Buttonhole.|The intervention group (I): repeated needling into the same site in the AVF with sharp needles (4-6 pieces) at each dialysis (1-3 dialyses) creating a buttonhole tunnel track where cannulation with a blunt needle is possible.
15856663|NCT03989141|Procedure|Single cannulation Buttonhole.|The control group (C): needling into the same site in the AVF with 1 sharp needle at each dialysis (6-12 dialyses) creating a buttonhole tunnel track, where cannulation with a blunt needle is possible. .
15856664|NCT03989128|Other|Medical Chart Review|Undergo medical chart review
15856665|NCT03989128|Other|Survey Administration|Complete survey
15856666|NCT03989115|Drug|RMC-4630|RMC-4630 for oral administration
15856667|NCT03989115|Drug|Cobimetinib|Cobimetinib for oral administration
15856668|NCT03989115|Drug|Drug: Osimertinib|Osimertinib for oral administration
15856669|NCT03989102|Biological|PfSPZ Vaccine/Normal Saline|PfSPZ vaccine is comprised of aseptic, metabolically active, non-replicating, purified, cryopreserved P. falciparum sporozoites. Sterile isotonic (0.9%) normal saline is a clear liquid, making it indistinguishable from the study product when drawn up into a syringe; and will be used as a placebo, rather than a comparator vaccine
15856670|NCT03989089|Drug|Pembrolizumab|"The planned dose of pembrolizumab for this study is 200 mg every 3 weeks (Q3W). Based on the totality of data generated in the Keytruda® development program, 200 mg Q3W is the appropriate dose of pembrolizumab for adults across all indications and regardless of tumour type.
~All participants who off study treatment with stable disease (SD) or better may be eligible for up to an additional 17 cycles (approximately 1 year) of pembrolizumab treatment if they progress after stopping study treatment from the initial treatment phase. This retreatment is termed the Second Course Phase of this study and is only available if the study remains open and the participant met certain criteria as stated in the protocol."
15856671|NCT03989076|Procedure|Interscalene Brachial Plexus Block|Analgesic nerve block as part of routine care with pre- and post-block ultrasonographic imaging of the diaphragm and inferior vena cava
15856672|NCT03989063|Behavioral|Instructions to perform a motor task (external vs. internal focus instructions)|During the balance task, the participants will receive instructions to focus on external targets (external focus group) vs. movement of the body (internal focus group).
15856673|NCT03989037|Drug|SIBP-01|IBP-01: injection; strength: 150mg; first dose 8mg/kg (intravenous infusion, not less than 90 minutes, on the 1st day of each cycle), then 6mg/kg once every 3 weeks, totaling 6 cycles
15856674|NCT03989037|Drug|Herceptin|Herceptin: injection; strength: 440mg; first dose 8mg/kg (intravenous infusion, not less than 90 minutes, on the 1st day of each cycle), then 6mg/kg once every 3 weeks, totaling 6 cycles
15856675|NCT03989037|Drug|Docetaxel|Docetaxel: injection; dose 75mg/m2, 75mg/m2 once every 3 weeks (intravenous infusion, not less than 60 minutes, on the 1st day of each cycle), totaling 6 cycles;
15856676|NCT03989037|Drug|Carboplatin|Carboplatin: injection; dose AUC6, AUC6 once every 3 weeks (intravenous infusion, not less than 30 minutes, on the 1st day of each cycle), totaling 6 cycles;
15856677|NCT03989024|Drug|Gonadorelin|Drug: Gonadotropin-releasing Hormone. Generic name: Gonadorelin. Dosage form: 600ug. Dosage: 10ug/puls. Frequency: every 90 min. Duration: 3 months
15864036|NCT03929692|Other|Standard health education|
15856678|NCT03989024|Drug|Clomiphene|Drug: Clomiphene. Generic name: Clomiphene. Dosage form: 50mg. Dosage: 50mg. Frequency: once a day. Duration: 3 months
15856679|NCT03989011|Diagnostic Test|Carotid Artery Reactivity test (CAR test)|The CAR test will be applied to stimulate the sympathetic nervous system. This thermal stimulus is known to elevate blood pressure via sympathetic pathways, so it can be used to study the vascular response to sympathetic activation. The participant will submerge their left hand in a bucket of ice water (approximately 4 degrees celsius) for 3 minutes, which is reported to be sufficient to induce a maximal dilation in the common carotid artery. At baseline and every minute after the hand is submerged in ice water, the blood pressure will be measured to check whether a sympathetic stimulation is achieved.
15856680|NCT03989011|Diagnostic Test|Arterial stiffness|"The SphygmoCor device will be used to non-invasively measure arterial stiffness parameters using applanation tonometry. For Pulse Wave Analyses (PWA), the radial waveform will be recorded. Approximately 10 waveforms are averaged, resulting in several non-invasive parameters:
~Peripheral pressure parameters
~Central and abdominal aneurysm pressure parameters (derived using a transfer function)
~Cardiac output parameters (SEVR, ED)
~Pulse wave velocity will be performed by recording the waveforms of the carotid and femoral artery sequentially. The travelled distance will be measured according to the current guidelines and entered in the program. The program will calculate the PWV based on 10 ECG triggered waveform of each artery."
15856681|NCT03988998|Drug|Radiofrequency ablation with radiotherapy|Radiofrequency ablation with radiotherapy
15856682|NCT03988998|Drug|Radiofrequency ablation alone|Radiofrequency ablation without radiotherapy
15856683|NCT03988985|Other|Patient-targeted feedback|The feedback for the patient contains the screening result, information about depression in general, guideline based treatment recommendations for patients and contact-information for treatment.
15856684|NCT03988985|Other|GP-targeted feedback|The feedback for the general practitioner contains the screening result and guideline-based recommendations, i.e. to inform patients of their depression screening result. Nevertheless, in order to reflect routine clinical practice, the physicians will decide themselves whether or not to address depression during their consultation with the patient.
15856685|NCT03988972|Device|diathermy|In women undergoing C.S, is healing power after diathermy equally to healing power after scalpel?
15856686|NCT03988972|Device|scalpel|Incisions made by the scalpel will be done by the traditional method, with proper hemostasis by application of pressure to skin blood vessels and by ligating the subcutaneous bleeders.
15856687|NCT03988959|Procedure|resection of mucoeidermoid carcinoma|Surgical resection parotid with preservation of facial nerve
15856688|NCT03988946|Device|Transcatheter Mitral Valve Replacement via Transseptal Access|The Cephea Transseptal Mitral Valve System is intended for use in symptomatic patients with moderate to severe degenerative or functional mitral regurgitation, who are poor candidates for surgery and who are anatomically eligible for the treatment.
15856689|NCT03988933|Drug|Rifampin double dose|Double dose of rifampin for 2 months.
15856690|NCT03988933|Drug|Rifampin triple dose|Triple dose of rifampin for 2 months.
15856691|NCT03988933|Drug|Rifampin standard dose|Standard dose of rifampin for 4 months.
15856692|NCT03988920|Drug|Tenapanor|NHE3 Inhibitor
15856693|NCT03988920|Drug|Sevelamer Carbonate|Phosphate binder
15856694|NCT03988907|Drug|Risdiplam|Part 1: a dose of 5 milligram (mg) risdiplam QD ; Part 2: precise dose will be based on Part 1 results
15856695|NCT03988907|Drug|Midazolam|single dose administration of 2 mg midazolam
15856696|NCT03988894|Device|mDASHNa App|The functions of the app will include: (a) antihypertensive dietary education; (b) dietary self-assessment; (c) automatic feedback according to dietary self-assessment; (d) blood pressure monitoring; and (e) automatic feedback according to blood pressure data.
15856697|NCT03988881|Procedure|Revascularization|PCI or CABG
15856698|NCT03988855|Drug|DNV3837|Treatment infusions will be administered at a constant rate resulting in a total IV infusion duration of 6 hours per day, for a total maximum daily dose of 120 mg DNV3837. Infusions will be administered once daily for 10 consecutive days.
15856699|NCT03988855|Drug|Standard of Care|Standard of care will be administered at the discretion of the Investigator. All regimens according to current guidelines (Infectious Diseases Society of America/Society for Healthcare Epidemiology of America and European Society of Clinical Microbiology and Infectious Diseases guidance on CDI) and bezlotoxumab are acceptable.
15856700|NCT03988842|Drug|Alteplase|Lyophilized powder for reconstitution in 50mg vials
15856701|NCT03988842|Drug|Unfractionated heparin|Heparin sodium in 0.45% sodium chloride injection for intravenous use
15856702|NCT03988842|Drug|Placebo|Saline solution reconstituted to mimic Alteplase 50mg vial
15856703|NCT03988842|Drug|Apixaban|Apixaban tablet
15856704|NCT03988829|Behavioral|Low-C|This is the active control group, where participants will be trained to play an experimenter developed game that requires least attentional control among all arms.
15856705|NCT03988829|Behavioral|High-C|In this intervention, participants will be trained on this experimenter developed game which requires a lot of attentional control.
15856706|NCT03988829|Behavioral|High-C+|A commercial video game will be used that requires a lot of demand on attentional control.
15856707|NCT03988816|Drug|Roflumilast|500Mcg Tab, once daily
15856708|NCT03988816|Drug|Placebo oral tablet|once daily
15856709|NCT03988803|Drug|BI 425809|Film coated tablet
15856710|NCT03988803|Drug|Memantine|Film coated tablet
15856711|NCT03988790|Device|VOC analysis|VOC analysis in exhaled air with e-noses and mass spectrometry.
15856712|NCT03988777|Device|Preoperative localisation technique|Impalpable breast lesions are preoperatively localised, either with hooked-wire (retrospective study) or Magseed (prospective study)
15856713|NCT03988751|Behavioral|Ambulation|Variation in ambulatory intensity.
15856714|NCT03988738|Other|Social Media Publications|Messages will be elaborated prior to participant enrollment. Messages will be evaluated by three experts.
15856715|NCT03988725|Dietary Supplement|Vitamin E|Vitamin E 800 IU once daily
15856716|NCT03988712|Diagnostic Test|Colonoscopy, gastroscopy, virtual colonoscopy, CT scan|Patients referred with a suspected bowel malignancy were subjected to top and bottom endoscopic examination or a cross sectional imaging like CT scan and MRI scan.
15856717|NCT03988699|Device|Tinnitus Implant System|Device will deliver stimulation below hearing thresholds continuously or intermittently.
15856718|NCT03988686|Procedure|Radical prostatectomy plus standard care|To add radical prostatectomy on the basis of current standard of care for those with oligometastatic prostate cancer
15856719|NCT03988686|Drug|Standard of care for metastatic prostate cancer|androgen deprivation therapy with or without other systemic therapies based on current guidelines for metastatic prostate cancer
15856720|NCT03988673|Other|Decision aid with implicit values clarification method (booklet or website)|The intervention will be an informative evidence-based material in the format of a booklet or website concerning prostate cancer screening. The values clarification method will be a grid where statements about the subject will be presented (decision aid with implicit VCM).
15856721|NCT03988673|Other|Decision aid with explicit values clarification method (booklet or website)|The intervention will be an informative evidence-based material in the format of a booklet or website concerning prostate cancer screening. The values clarification method will be a a grid where statements about the subject will be presented and men should indicate what statements they identify with (decision aid with explicit VCM).
15856722|NCT03988660|Diagnostic Test|Circulating fibrocytes|Peripheral blood samples were taken from the patients presented with right iliac fossa pain. Samples were collected in sodium heparin (EDTA). Circulating fibrocyte levels were determined by dual staining peripheral blood samples for CD4 and Col-1 using Fluorescence-Activated Cell Sorting (FACS) and correlated with histopathological diagnosis.
15856723|NCT03988647|Drug|Pembrolizumab|Pembrolizumab administered at 200 mg IV every 3 weeks
15856724|NCT03988647|Radiation|Radiation Therapy|9 Gy X 3 (27 Gy in 3 fractions), or 4-6 Gy X 5 (20-30 Gy in 5 fractions).
15856725|NCT03988634|Drug|sacubitril/valsartan|"Sacubitril/valsartan (LCZ696) is available as 24/26 mg, 49/51 mg, and 97/103 mg in tablet form to be taken orally, twice daily, for the double-blind period.
~Valsartan matching placebo is available as 40 mg, 80 mg, and 160 mg in tablet form to be taken orally, twice daily, for the double-blind period."
15856726|NCT03988634|Drug|valsartan|"Valsartan is available as 40 mg, 80 mg, and 160 mg in tablet form to be taken orally, twice daily, for the double-blind period.
~Sacubitril/valsartan (LCZ696) matching placebo is available as 24/26 mg, 49/51 mg, and 97/103 mg in tablet form to be taken orally, twice daily, for the double-blind period."
15856728|NCT03988608|Drug|Eltrombopag 25 mg|film-coated tablets containing 25 mg of eltrombopag free acid in each tablet
15856729|NCT03988595|Other|Exercise Treatment|Exercise sessions will consist of individualized, walking delivered following a non-linear (i.e.,exercise intensity is continually altered and progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule across 3 to 5 individual treatment sessions/wk for 6 months. All exercise sessions will be implemented and monitored using TeleEx at the patient's home. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology.
15856730|NCT03988582|Biological|EBV-specific T-cells|During each cycle, patients will receive intravenous (IV) EBV-CTLs at a dose of 1×106 CD3+ cells/kg on Days 1, 8, and 15, followed by a 2-week observation period.
15856731|NCT03988569|Other|audiovisual decision aid|Will view AVDA and then have opportunity for questions with physician before signing consent forms
15856732|NCT03988556|Device|Photobiomodulation using CareMin650 at 6 Joules (curative intent)|"CareMin650 is a photobiomodulation device which consists of a Lightbox and a light applicator to deliver red light with wavelength of 650 nm and irradiance between 10 and 50 mW/cm² to skin or mucosa.
~For curative treatment, the dose to be delivered has been set at 6J/cm2. If the lesions of patients included in a curative cohort are resolved before the end of the radiotherapy period, the treatment will be applied with a preventive aim and the dose will decrease from 6 to 3J/cm2."
15856733|NCT03988556|Device|Photobiomodulation using CareMin650 at 3 Joules (prophylactic intent)|"CareMin650 is a photobiomodulation device which consists of a Lightbox and a light applicator to deliver red light with wavelength of 650 nm and irradiance between 10 and 50 mW/cm² to skin or mucosa.
~For prophylactic treatment, the dose to be delivered has been set at 3J/cm2. If oral mucositis or radiodermatitis occurs in a patient included in a prophylactic cohort, the lesions will be treated with a curative intent and the dose will increase from 3 to 6J/cm2."
15856734|NCT03988543|Behavioral|Patient Self-management|Enhanced care (EC) approach aimed to engage participants actively, and to increase self-efficacy, in the monitoring and managing of their symptoms. After patients complete the current EHR-integrated symptom monitoring, they will receive web-based, patient-centered information to gain knowledge on cancer-related outcomes, improve self-management skills, improve communication skills, and empower them to improve motivation and self-management.
15856735|NCT03988530|Drug|Scopolamine|Subjects will self-administer DPI-386 Nasal Gel (0.2 mg / 0.12 g) or placebo nasal gel (0.12 g) on Treatment Day 1, and on Treatment Days 2 -4 all subjects will self administer DPI-386 Nasal Gel (0.2 mg / 0.12 g).
15856736|NCT03988530|Other|Placebo Nasal Gel|Placebo Nasal Gel (0.12g) twice a day on Treatment Day 1.
15856737|NCT03988517|Other|timing of receiving the drug|each group took levothyroxine in different timing
15856738|NCT03988504|Diagnostic Test|Routine check up including genetic testing|Intervention is a routine check up including preemptive genetic testing
15856739|NCT03988478|Behavioral|Detoxification & psychotherapeutic support|
15856740|NCT03988465|Diagnostic Test|Quantra System|Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
15856741|NCT03988452|Drug|Darunavir|Antiretroviral therapy
15856742|NCT03988452|Drug|Ritonavir|Antiretroviral therapy
15856743|NCT03988452|Drug|Dolutegravir|Antiretroviral therapy
15856744|NCT03988452|Drug|Zidovudine|Antiretroviral therapy
15856745|NCT03988452|Drug|Tenofovir|Antiretroviral therapy
15856746|NCT03988452|Drug|Lamivudine|Antiretroviral therapy
15856747|NCT03988439|Drug|IDP-118 Lotion|Topical
15856748|NCT03988426|Biological|Octanorm|Octanorm
15856749|NCT03988413|Drug|25mg|SYHA1402 25mg or Placebo 25mg
15856750|NCT03988413|Drug|50mg|SYHA1402 50mg or Placebo 50mg
15856751|NCT03988413|Drug|100mg|SYHA1402 100mg or Placebo 100mg
15856752|NCT03988413|Drug|200mg|SYHA1402 200mg or Placebo 200mg
15856753|NCT03988413|Drug|400mg|SYHA1402 400mg or Placebo 400mg
15856754|NCT03988413|Drug|800mg|SYHA1402 800mg or Placebo 800mg
15856755|NCT03988400|Behavioral|Sensory Augmentation|Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration delivered over the hip abductor musculature will scale with the mechanical state of the pelvis at the start of each step. For example, if the step begins with the pelvis far mediolaterally from the stance foot, the swing leg hip abductors will receive strong vibration. If instead the step begins with the pelvis close mediolaterally to the stance foot, the stance hip abductors will receive strong vibration.
15856756|NCT03988400|Behavioral|Random Vibration|Participants will complete 8 training sessions over 4 weeks, in which they walk on a treadmill at their self-selected speed. During training sessions, the magnitude of the vibration applied to the hip abductors will vary randomly (following a normal distribution) on a step-by-step basis.
15856757|NCT03988387|Behavioral|Peer Support (PS)|Participants randomized to the PS arm will be assigned a trained peer supporter. The peer supporters (PSr) will establish rapport and build trusting relationships with participants in order to increase self-efficacy and motivation to adhere to the daily PrEP regimen and to engage in HIV prevention behaviors, in general. The PSrs will assess for facilitators and barriers to PrEP adherence, conduct adherence counseling, and provide ongoing social and practical support (e.g. tailored appointment reminders, accompanying participants to medical appointments, and providing skills building for effective relationships with study site providers). PSrs will communicate with the participant on at least a weekly basis either in person or by phone and will track those who miss scheduled study visits. Participants will be encouraged to contact their PSrs in case of questions or concerns. For any clinical question, the peer supporter will direct the participant to the study nurse.
15856758|NCT03988387|Behavioral|Reminder and Resource Transfer (RRT)|"Participants who are randomized to the RRT arm will receive a discrete weekly SMS text (or voice message if participant is illiterate) to encourage healthy behaviors, study engagement and PrEP adherence. Messages will be a general message that the participant has selected and will not have any information identifying the participant as part of the study or describing the purpose of the study. An example text is Remember to look after yourself today, See you tomorrow. Participants will be requested to respond to the message with a brief answer. Participants will be advised that each answered text counts as a point toward resource transfer that can be redeemed at scheduled study visits in the form of a small gift, such as cosmetics, personal care items, accessories, or airtime.The value of the reward increases with points."
15856759|NCT03988387|Drug|daily oral PrEP (emtricitabine 200 mg/tenofovir 300 mg) [FTC/TDF]|All participants will receive a one-month supply of daily oral PrEP (emtricitabine 200 mg/tenofovir 300 mg) [FTC/TDF] for the first month of enrollment.
15856760|NCT03988374|Drug|Dentifrices|Dentifrice on plaque, gingivitis, and bleeding.
15856761|NCT03988361|Diagnostic Test|Magnetic Activated Cell Sorting|At the moment of ICSI, sibling mature oocytes will be inseminated with spermatozoa from Study group or from Control group. Following ICSI, all the inseminated oocytes will be individually cultured in the same conditions in the same culture dish. The choice of embryo(s) for transfer will be based on embryo quality. The supernumerary good-quality embryos from both arms will be frozen for further use.
15856762|NCT03988348|Procedure|infraumbilical transverse incision|a 10 mm infraumbilical transverse incision will be done to allow trocar to be inserted without undue resistance from the skin so that the trocar will pass through the fascia and the peritoneum with ease
15856763|NCT03988348|Procedure|intraumbilical incision|right sided curved longitudinal intraumbilical incision will be performed for initial intraperitoneal access
15856764|NCT03988335|Drug|RIST4721|RIST4721 oral solution
15856765|NCT03988335|Drug|Placebo|Placebo oral solution
15856766|NCT03988322|Other|Low-dose CT screening with quantitative assessment and management of imaging biomarkers|Participants will be screened with a low-dose CT (a Philips 256-slice CT system). The CT images will be obtain according to the pre-defined CT scan protocol. This CT protocol is developed for quantitative assessment of lung nodules, COPD and coronary artery calcium. Detected lung nodules will be managed according to the European volume-based protocol, based on the volume and volume doubling time of lung nodule. COPD will be management according to the result of lung function test. The imaging biomarkers (eg., emphysema index, airway wall thickness, and coronary artery calcium ) will be quantitatively registered. In addition, a number of participants' characteristics will be collected: physical examination (weight, height, blood pressure), laboratory measurements (eg., fasting plasma glucose, total cholesterol, HDL-cholesterol). The social-demographic characteristics, risk factors of the 3 diseases, and health status of the participants will be collected through questionnaires.
15856767|NCT03988322|Other|Low-dose CT screening with visual assessment and management of imaging biomarkers|Participants will be screened with a low-dose CT (a Philips 64 MDCT system). The CT images will be obtain according to the routine CT scan protocol for lung cancer screening in the hospital. Detected lung nodules will be managed according to the diameter of the nodule based on the NCCN Clinical Practice Guideline in Oncology for Lung Cancer Screening. Detected emphysema and/or bronchial wall thickness, coronary artery calcium will be qualitatively recorded (yes/no).
15856768|NCT03988309|Diagnostic Test|Cxbladder|"The Cxbladder Triage test result will be provided to physicians for all low risk subjects on the test arm. If a low risk subject has a Cxbladder Triage negative test result then the indication is to rule out the subject without further assessment. The decision to rule-out or further evaluate is solely that of the physician and subject. If the low risk subjects are not Cxbladder Triage negative then a Cxbladder Detect test result will also be provided. The indication is further evaluation as per standard of care. Not low risk patients will be evaluated as per standard of care."
15856769|NCT03988283|Biological|Personalized neoantigen DNA vaccine|At each vaccination time point, patients will receive two injections of the neoantigen DNA vaccine, one injection into each deltoid or lateralis.
15856770|NCT03988283|Device|TDS-IM System|The TDS-IM device utilizes the in vivo application of electrical fields to enhance the intracellular delivery of agents of interest in a targeted region of tissue
15856771|NCT03988283|Procedure|Peripheral blood draw|-After trial enrollment and up to 7 days after the first vaccine dose (baseline); 2 weeks after last dose; time of progression or discontinuation (optional); other time points throughout the study if deemed pertinent to assessment of exploratory objectives (optional)
15856772|NCT03988270|Other|Exercise|Participant randomized to an exercise protocol using a hand grip device that is used on a daily basis. Participant will be encouraged to increase the number of repetitions used by the hand grip device during the course of the trial
15856773|NCT03988257|Dietary Supplement|Imunoglukan PH4|Children allocated to experimental group will receive Imunoglukan PH4 syrup (10 mg of pleuran and 10 mg of vitamin C in 1 ml of syrup) in a dose 1 ml / 5 kg body weight, once a day in the morning, before the first meal, until signs of AGE subside (< 3 stools / 24 hours and normalization of stool consistency - grade 2-5 according to Bristol Stool Form Scale) or until the 14th day of the intervention.
15856774|NCT03988257|Dietary Supplement|Placebo (vitamin C syrup)|Children allocated to control group will receive a placebo: a vitamin C syrup (10 mg of vitamin C in 1 ml of syrup) in a dose 1 ml / 5 kg body weight, once a day in the morning, before the first meal, until signs of AGE subside (< 3 stools / 24 hours and normalization of stool consistency - grade 2-5 according to Bristol Stool Form Scale) or until the 14th day of the intervention.
15856775|NCT03988244|Device|HeartLight X3|Pulmonary vein isolation
15856776|NCT03988231|Drug|Receipt of enoxaparin|Patients will be randomized to enoxaparin 40mg once daily versus saline placebo at 8 hours after surgery and continued for the duration of inpatient stay.
15856777|NCT03988231|Drug|Placebo|Patients will be randomized to enoxaparin 40mg once daily versus saline placebo at 8 hours after surgery and continued for the duration of inpatient stay.
15856778|NCT03988218|Behavioral|perceptive tests|many tests are realized: a drawing of the interior of the body a heartbeat detection test an ischemia induction test many scales: Eating Attitude Test; Body Awareness Questionnaire; Body Shape Questionnaire; Hospital Anxiety and Depression; Questionnaire de Satisfaction Corporelle et de Perception Globale de Soi
15856779|NCT03988205|Behavioral|Outpatient Care Model|Outpatient care model includes a nurse teacher educational program, scheduled outpatient visit protocol, and quality of life surveys for both subjects and caregivers.
15856780|NCT03988205|Drug|CPX-351|CPX-351 is administered, according to FDA approval, to subjects who meet medical and logistical criteria for study enrollment.
15856781|NCT03988192|Device|VOC analysis|VOC analysis in exhaled air with e-noses and mass spectrometry.
15856782|NCT03988179|Diagnostic Test|The Cholinesterase Inhibitor Prognosticator (ChIP) application for iPad|The first part of this application will be used, consisting of a visual vigilance test based on the Continuous Performance Test (CPT). Stimuli consist of a one digit number presented in the middle of the screen. For each trial the application randomly selects a specific number as the target stimulus. Patients are instructed to keep their dominant trigger finger close to the screen and press a button which is located at the bottom of the screen, whenever the target appears. In case another stimulus appears the patient is instructed to do nothing. Each stimulus is presented until the patient presses the button (maximum 3 sec.). Stimuli are presented in a random fashion with a 1, 2, 3, 4, or 5 second inter-stimuli-interval blank, which randomly varies. After an 8 stimuli practice trial, the test starts and a total of 50 stimuli are presented with a 50% target rate. Full-trial duration is approximately 5 minutes. During the trial, reaction time and accuracy of response are registered.
15856783|NCT03988166|Procedure|Chronic Total Occlusion Revascularization|Teleflex's series of study guidewires and catheters will be used to facilitate the safe and effective crossing of de novo CTOs and placement of conventional guidewires beyond the lesion via either a true lumen or subintimal pathway.
15856784|NCT03988166|Device|GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter|GuideLiner® V3 catheter, TrapLiner® catheter, Turnpike® catheter
15856785|NCT03988153|Combination Product|Probiotic Milk Formula|Drink 200 mL of PMF for 10 weeks and followed by 2 weeks of follow up period for monitor any adverse effect
15856786|NCT03988140|Device|Dental Implant Placement and subsequent prosthetic reabilithation|Surgeries to dental implant placement were performed. All patients received 3.5 mm diameter dental implants - surface blasted with TiO2 particles and machined collar of 1mm - in the interforaminal region of the mandible. The surgical sequence followed the protocol described by the implant company.A two stages protocol was used and the prostheses were placed at 4 months.The prosthetic retention system used in rehabilitation with overdentures was the O'ring and the capture of this component was done directly in the patient's mouth. After 7 and 14 days, the patients returned to occlusal adjustments and verification of prosthetic adaptation. The prostheses were made entirely of acrylic resin without metallic reinforcement and the antagonist of the patients were total edentulous and rehabilitated with muco-supported prostheses.
15856787|NCT03988127|Diagnostic Test|Perfusion index|The perfusion index (PI) is the ratio of the pulsatile to the non-pulsatile blood flow in peripheral tissue. It represents a non-invasive measure of peripheral perfusion that can be continuously obtained from a pulse oximeter. We observe changes in PI before and after painful stimulation in intubated critically ill patients.
15856788|NCT03988114|Drug|Abemaciclib|Administered orally
15856789|NCT03988114|Drug|Nonsteroidal Aromatase Inhibitor (NSAI)|Letrozole administered orally or anastrozole administered orally (physician choice)
15856790|NCT03988101|Drug|Rosuvastatin 20mg|Patients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of rosuvastatin 20 mg once daily or equivalent.
15856791|NCT03988101|Drug|Control|Patients who are eligible for all of the criteria and who do not qualify as exclusion criteria should be enrolled in the study and randomly enrolled in a 1: 1 dose of rosuvastatin 20 mg once daily or equivalent.
15856792|NCT03988088|Drug|Lasmiditan|Administered orally.
15856793|NCT03988075|Other|Acetaminophen and hydrocodone based pain control|Patients receive acetaminophen 650mg every 4 for pain level 1-3, hydrocodone/acetaminophen 5/325mg every 4 for pain level 4-6, or hydrocodone/acetaminophen 10/650mg every 4 for pain level 7-10 on as needed basis.
15856794|NCT03988075|Other|Acetaminophen and ibuprofen based pain control|Patients receive standing dose of acetaminophen 650mg every 8 hours and ibuprofen 800mg every 8 hours with alternating ibuprofen and acetaminophen every 4 hours.
15856795|NCT03988062|Device|TrelliX Embolic Coil System|Embolic coil with shape memory polymer
15856796|NCT03988049|Device|1,550 fracionated photothermolysis laser|All subjects will have one side of their face treated with one laser, and the other side with the other laser.
15856797|NCT03988049|Device|755 picosecond laser|All subjects will have one side of their face treated with one laser, and the other side with the other laser.
15856798|NCT03988036|Drug|Pembrolizumab|Intravenous infusion; 200 mg; every 3 weeks
15856799|NCT03988036|Drug|Trastuzumab Biosimilar ABP 980|Intravenous infusion; 8 mg/kg loading dose, thereafter 6 mg/kg; every 3 weeks
15856800|NCT03988036|Drug|Pertuzumab|Intravenous infusion; 840 mg/kg loading dose, thereafter 420 mg/kg; every 3 weeks
15856801|NCT03988023|Biological|Ampion|Ampion (<5 kilodalton (kDa) ultrafiltrate of 5% HSA)
15856802|NCT03988023|Other|Saline|Saline solution, 4 mL, single intra-articular injection
15856803|NCT03988010|Drug|Amantadine Sulfate|200mg/500ml i.v. solution for infusion
15856804|NCT03988010|Drug|Placebo (for amantadine sulphate)|500 cc 0.9% sodium chloride
15856805|NCT03987997|Device|Early association of electrical muscle stimulation with cyclo-ergometer|Early electrical muscle stimulation in patients usually mobilized with cyclo-ergometer in ICU.
15856806|NCT03987971|Other|acupuncture|Acupuncture on GB26, every other day, 3 times a week, 2 weeks in total.
15856807|NCT03987945|Device|left atrial appendage occlusion devices|All NVAF patients who are admitted for receiving left atrial appendage occlusion procedure, including Watchman, LAmbre, Lefort, and Leftear deveices.
15856808|NCT03987932|Behavioral|NEAT!2|Participants randomized to NEAT!2 will have their NEAT!2 app turned on after randomization. When 30 minutes of continuous non-movement or sedentary time is detected, the NEAT!2 app will provide a vibration or audio notification as well as display a reminder on the phone's lock/home screen. Participants will be asked to use the app for the 3 months of the intervention. Participants will be given an initial goal to reduce total sedentary time by 30 minutes/day, ultimately progressing to a 90 minute/day reduction by 3 months. After the 3-month assessment, participants randomized to NEAT!2 will have the option to continue using the app until 6 months.
15856809|NCT03987932|Behavioral|NEAT!2+Calls|Participants in this group will have their NEAT!2 app turned on after randomization. In addition, to receiving the identical app and given the same goals as participants randomized to NEAT!2, NEAT!2+Calls participants will receive 10-15 minute bi-weekly coaching calls. After the 3-month assessment, participants will have the option to continue using the app until 6 months. During this time, participants will not receive any coaching calls.
15856810|NCT03987932|Behavioral|Delayed NEAT!2|Participants randomized to Delayed NEAT!2 will not receive any contact or app between baseline and 3 months. However, after completing the 3-month assessment, participants will receive the NEAT!2 application. Participants will then have the option to use the app between 3 and 6 months.
15856811|NCT03987919|Drug|Tirzepatide|Administered SC
15856812|NCT03987919|Drug|Semaglutide|Administered SC
15856813|NCT03987906|Behavioral|Symptom screening with Targeted Early Palliative Care (STEP)|The experimental arm receives routine symptom screening at every outpatient visit; if symptoms are above a certain threshold, then a triggered email is sent to a triage nurse, who calls the patient to offer early referral to and follow-up by a symptom control and palliative care team.
15856814|NCT03987893|Drug|PEG-3350 with Electolytes|experimental arm will receive 2 doses of PEG3350 spaced over 12 hours after randomization to arm1. PEG as dose of 2litres (1 sachet dissolved in 2L of water) will be administered via a nasogastric tube.
15856815|NCT03987893|Drug|Lactulose|Lactulose will be given orally (30ml QID) which shall be titrated to ensure 2-3 soft stools per day
15856816|NCT03987880|Procedure|4.0 mm treatment|PiXL treatment with UV irradiation in a central 4.0-mm ring-shaped zone of the cornea.
15856817|NCT03987880|Procedure|3.5 mm treatment|PiXL treatment with UV irradiation in a central 3.5-mm ring-shaped zone of the cornea.
15856818|NCT03987867|Biological|CIK cell|CIK cell injection
15856819|NCT03987867|Biological|Sintilimab Injection|IBI308 injection
15856820|NCT03987867|Drug|Pemetrexed|Pemetrexed injection
15856821|NCT03987867|Drug|Liposome paclitaxel|Liposome paclitaxel injection
15856822|NCT03987867|Drug|Carboplatin|Carboplatin injection
15856823|NCT03987854|Behavioral|diet and lifestyle program|Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep. They will also be taught taught about positive affect skills (such as gratitude, positive reappraisal, and personal strengths) and mindfulness (general mindfulness and mindful eating).
15856825|NCT03987815|Drug|Nivolumab|Nivolumab
15856826|NCT03987802|Drug|Faster-acting insulin aspart|Faster-acting insulin aspart given as subcutaneous (s.c., under the skin) injections according to routine clinical practice. The decision to initiate treatment with commercially available Fiasp® must be made by the patient and the treating physician before and independently from the decision to include the patient in this study.
15856827|NCT03987789|Other|Driving-pressure-guided group|Patients will receive PEEP levels individually set at the highest possible value (up to 15 cmH2O) providing a driving pressure (airway plateau pressure minus PEEP) lower than 13 cmH2O, in addition to recruitment maneuvers.
15856828|NCT03987789|Other|Low PEEP|Patients will receive a PEEP level ≤5 cmH2O without recruitment maneuvers
15856829|NCT03987776|Behavioral|Anti-inflammatory energy-restricted diet|During 6 months the participants will we asked to use recommended energy-reduced diet with anti-inflammatory properties, based on colorful vegetables and fruits, legumes, nuts, seeds, marine fish, whole-grain products, and daily use of olive oil, green/black tea, multiple spices and herbs.
15856830|NCT03987776|Behavioral|Control energy-restricted diet|During 6 months the participants of control group will be asked to use recommended energy-reduced diet based on standard obesity management (55-60% carbohydrates, 25% fat, 15-20% protein)
15856831|NCT03987763|Drug|IDP-122 Lotion|Topical
15856832|NCT03987750|Drug|Safinamide Methanesulfonate 150mg|150 mg (free base)
15856833|NCT03987750|Drug|Safinamide Methanesulfonate 100mg|100 mg (free base)
15856834|NCT03987750|Drug|Safinamide Methanesulfonate matching placebo|placebo
15856835|NCT03987737|Procedure|small urinary catheter placement in the rectum|The MRI technician will place a small urinary catheter in the rectum prior to MRI of the prostate to evacuate excessive gasses. This catheter will stay in the rectum during the whole MRI examination.
15856836|NCT03987724|Other|Positron emission tomography (PET) imaging at rest and during supine bicycle exercise|Tumor blood flow and its heterogeneity will be measured with PET at rest and during supine bicycle exercise.
15856837|NCT03987711|Drug|Warfarin|Individuals randomized to this arm will be exposed to dose-adjusted daily warfarin targeting an international normalized ratio (INR) of 2.0-3.0.
15856838|NCT03987711|Drug|Apixaban|Individuals randomized to this arm will receive apixaban 5 mg twice daily (a reduced dose of 2.5 mg twice daily will be given to selected participants).
15856839|NCT03987711|Other|No oral anticoagulation|No oral anticoagulation
15856840|NCT03987698|Biological|SHR-1210|SHR-1210 injection
15856841|NCT03987698|Biological|CIK cells|CIK cells injection
15856842|NCT03987685|Drug|Oratopo|Oral topotecan will be supplied in topotecan capsules and oral HM30181A-US tablets
15856843|NCT03987672|Dietary Supplement|Assess the nutritional effects of the Kate Farm Peptide 1.5 nutritional Formula|Kate Farm Peptide 1.5 nutritional Formula
15856844|NCT03987659|Procedure|Irrigation protocols that promote release of dECMs|Irrigation protocols that promote release of dECMs
15856845|NCT03987659|Procedure|Conventional Irrigation protocols|Conventional Irrigation protocols
15856846|NCT03987646|Procedure|Non-staged vestibular fresh socket therapy|a slowly resorbable membrane shield is placed above the labial plate of bone so that when the thin labial plate started its resorption process the shield remains till a complete gap fill occurred thus leading to a thicker labial plate of bone or it preserves the socket architecture until a complete bone fill occurred inside the socket
15856847|NCT03987620|Drug|Ibrexafungerp|Ibrexafungerp 300mg BID for one day
15856848|NCT03987620|Drug|Placebo|Matching Placebo
15856849|NCT03987607|Device|neuromuscular blockade monitoring|Neuromuscular blockade monitoring via two different types of monitoring devices
15856850|NCT03987594|Procedure|Transurethral fulguration of the Hunner lesion|Hunner lesion of the bladder is fulgurated with electronic surgical device under cystoscopic inspection. For the intervention, general or spinal anesthesia is required.
15856851|NCT03987594|Procedure|Combination treatment of bladder hydrodistension and transurethral fulguration of the Hunner lesion|Prior to Hunner lesion fulguration, bladder hydrodistension is performed for 8 minutes at pressure of 80cmH2O. And then transurethral fulguration is performed on the Hunner lesion.
15856852|NCT03987581|Behavioral|Cognitive Behavioral Therapy (CBT)|Twelve in-person counseling sessions designed to assist participants with becoming abstinent from alcohol use (or reduce use).
15856853|NCT03987581|Behavioral|Mobile Contingency Management (mCM)|Abstinence (measured by breath alcohol) will be intermittently reinforced. For each breath alcohol concentration reading that tests negative, a participant will earn a virtual scratch-off lottery ticket that contains 100 different values.
15856854|NCT03987581|Behavioral|Long-term incentive|This incentive is $300 for self-reported and bioverified 30-day abstinence from heavy drinking at the follow-up scheduled for 6-months after the initial quit date
15856855|NCT03987568|Other|Blood draws|Blood draws at two specified timepoints - the first is during the MRI and the second is scheduled during participant's prostatectomy.
15856856|NCT03987568|Diagnostic Test|Magnetic resonance imaging (MRI)|At the beginning of study magnetic resonance imaging MRI will be completed.
15856857|NCT03987555|Other|Blood draws|Blood draws for serum and peripheral blood mononuclear cell isolation collected throughout treatment course
15856858|NCT03987555|Other|QLQ-CIPN20 Survey|20-item self-reported survey for participant reported symptoms related to chemotherapy-induced peripheral neuropathy
15856859|NCT03987555|Other|PR-CTCAE Survey|124-item survey addressing chemotherapy-induced peripheral neuropathy concerning severity of the numbness and tingling and the degree these symptoms interfere with daily activities.
15856860|NCT03987529|Other|sevoflurane|volatile anesthetic
15856861|NCT03987529|Other|propofol|intravenous anesthetic
15856862|NCT03987516|Other|Active exercising|Patients allocated to the experimental group were included in an active exercising program adapted to each patient
15856863|NCT03987503|Drug|Epclusa (SOF/VEL)|a trained physician will provide research participants with two-week supply of SOF/VEL. Treatment is: 1 tablet SOF/VEL (400 mg sofosbuvir/100 mg velpatasvir) daily x 12 weeks. The initial 2-week supply is provided by Gilead Sciences and will be dispensed to participants upon enrollment. Prescriptions and insurance prior authorizations for SOF/VEL will be submitted by the study pharmacist though the UCSF Specialty Pharmacy. The study team will be notified once insurance-authorized drug is available and will bring participants' medication in 2 supplies to the study site prior to study visits.
15856864|NCT03987503|Drug|Standard of care|Standard of HCV care provided by medical care provider
15856865|NCT03987503|Device|Fibroscan® 430 Mini Plus|"Trained research staff will measure participants liver stiffness using liver ultrasonographic elastography. Research staff place ultrasound gel directly on participant's skin on the area of the torso. Research staff will position the participant's body on the exam table to assure the liver can be located, placing the small probe on the body's surface (skin with gel) and begin recording images of the participant's liver.
~The procedure will take 15-30 minutes, depending on the ease with which the research staff is able to accurately locate the participant's liver.
~Results from the FibroScan will be discussed with a trained provider."
15856866|NCT03987490|Behavioral|Text Message|Vaccine reminder notification sent via text
15856867|NCT03987490|Behavioral|PostCard|Vaccine reminder notification sent via standard mail
15856868|NCT03987490|Behavioral|Standard of Care|No additional information given to parents
15856869|NCT03987490|Behavioral|Motivational Interview|Phone-based semi-guided discussion with parents who had not yet agreed to vaccination after reminders sent
15856870|NCT03987477|Behavioral|Interpretation bias modification program|Brief online program aimed at the modification of negative interpretation biases.
15856871|NCT03987477|Behavioral|Waiting list|Waiting list procedure for the control group.
15856872|NCT03987464|Behavioral|Planning for the Future|This intervention will include attending an advance directives meeting, a living arrangements workshop, and a psychosocial education training workshop.
15856873|NCT03987464|Behavioral|Enhanced Medical Engagement|This intervention includes creating a health portfolio, health record access training, and a medical engagement workshop
15856874|NCT03987464|Behavioral|Confidence Building and Social Engagement|This intervention includes mindfulness training, a pre-experience training techniques workshop and a memory strategies class.
15856875|NCT03987464|Behavioral|Physical Intervention|This intervention includes physical/occupational therapy (PT/OT), a home safety assessment, and an independent exercise program.
15856977|NCT03986658|Device|Linear Asymmetric rTMS System|Linear Asymmetric rTMS System
15856978|NCT03986645|Device|MR data acquisition|MR data acquisition using CE and non-CE marked pulse sequences.
15856876|NCT03987464|Behavioral|Medical Adherence|This intervention includes using automated pillboxes to ensure medication compliance, optimizing appropriate medication use through review, and engaging with memory medications via class.
15856877|NCT03987451|Drug|Semaglutide|Semaglutide given subcutaneously (s.c., under the skin) once-weekly for 48 weeks
15856878|NCT03987451|Drug|Placebo (semaglutide)|Semaglutide placebo s.c. given once-weekly for 48 weeks
15856879|NCT03987438|Behavioral|Lifestyle intervention with APP|The lifestyle intervention will be launched by an APP installed in participants' private mobile phones, including health knowledge education, mental health counseling, smart diet advice, intelligent exercise guidance, and target weight management. Nutrition recommendation is conducted according to the Chinese Dietary Guide, Chinese and International Guidelines of Gestation Diabetes Management. Exercise guidance is given based on the Guidelines for National Fitness of China, Chinese and International Guidelines of Gestation Diabetes Management. Psychological support is given by sending education articles on mental health. Participants are encouraged to update data about their diet, exercise and body weight through the APP. The face to face education class will be conducted by an obstetrician, an endocrinologist and a nutritionist together to modify the behavioral supports individually based on the feedback of their characteristics and performance recorded in the APP.
15856880|NCT03987425|Device|CPAP treatment|In this group of patients (CPAP group) will be prescribed CPAP treatment at optimal pressure. It will be performed a CPAP titration with an automatic or manual CPAP according to usual clinical practice.
15856881|NCT03987412|Behavioral|Lifestyle intervention with APP|The face to face education class will be conducted by an obstetrician, an endocrinologist and a nutritionist together. Then the lifestyle intervention will be launched by an APP that installed in participants' private mobile phones, including nutrition, exercise and phycological support. Nutrition guidance is conducted according to the Chinese Dietary Guide, Chinese and international guidelines of gestation diabetes management. Exercise support is given based on the Guidelines for National Fitness of China, Chinese and international guidelines of gestation diabetes. Phycological support is given by sending education articles on mental health. Participants are encouraged to update data about their diet, exercise and body weight through the APP, and based on the data investigators will individualize the suggestions.
15856882|NCT03987399|Other|Tailored educational intervention|Educational day (lecture and workshop), clinical supervision and reminders
15856883|NCT03987386|Radiation|Hypofractionated Radiation Therapy|Undergo hypofractionated radiation therapy
15856884|NCT03987386|Other|Quality-of-Life Assessment|Ancillary studies
15856885|NCT03987386|Other|Questionnaire Administration|Ancillary studies
15856886|NCT03987386|Radiation|Radiation Therapy|Undergo conventional radiation therapy
15856887|NCT03987373|Other|non-interventional|This study is a non-interventional, observational study. After completing 12-month treatment from DACAB trial, investigators would not make any interventions or impact on subjects' therapeutic strategy.
15856888|NCT03987360|Other|Observational|Participants who attended different educational and cultural activities either in a community centers or public institutions like arts museums or universities.
15856889|NCT03987347|Other|Observational|People who are enrolled in the Canadian Longitudinal Study on Aging. Participants undergo repeated waves of the same standardized data collection every three years. All participants are also contacted by telephone 18 months after baseline assessment to complete the Maintaining Contact Questionnaire.
15856890|NCT03987334|Other|Virtual Reality Treatment|Experimental Group (VRT) subjects will undergo Virtual Reality Motor Control exercises based on augmented feedback of their performance.
15856891|NCT03987334|Other|Control Group|Control Group (CT) subjects will undergo the same treatment of VRT subjects in terms of intensity, time and type, but with the VR turned off.
15856892|NCT03987321|Device|Infrarenal vena cava filter placement|Patients who are enrolled in this study are assigned to receive either Denali or Celect filter in the inferior vena cava. All other procedures are the same in both groups
15856893|NCT03987308|Drug|Beinaglutide|Five-week Beinaglutide pump treatment group
15856894|NCT03987308|Drug|Insulin aspart|Five-week short-term CSII (insulin aspart) treatment group
15856895|NCT03987295|Drug|AL001|administered via intravenous (IV) infusion once a month
15856896|NCT03987282|Other|Enhanced usual care (EUC)|Provision of ART and medical care for HIV and other medical HIV co-morbidities provided at the HIV/AIDS treatment center with an expedited and facilitated referral to a methadone maintenance treatment (MMT).
15856897|NCT03987282|Behavioral|Peer-based counseling|Peer-based counseling intervention focused on behavioral skills and strategies that patients can learn and master to achieve uninterrupted, long-term ART treatment participation while continuing OUD recovery through MMT
15856898|NCT03987269|Behavioral|Embodied Virtual Reality|"The video will be formatted for viewing within a standard virtual reality headset. Once the video begins, subjects will follow the movements of the new body they are inhabiting in synchronicity to the video. Movement and haptic input include
~Mimicking the hand gestures at the beginning in order to establish the body transfer illusion.
~Shaking someone's hand
~Someone holding the hand and elbow to assist them in standing, taking a few steps and returning to a seated position.
~Shaking hands
~Having their blood pressure taken
~Having their pulse taken
~Fill a pill organizer
~Color a picture
~All of the above interactions will be facilitated by the two Co-PI's (Blatter, Ware). Blatter and Ware have been creating and performing similar Virtual Reality Embodiments with haptics for the past year, and to date, have performed hundreds of them for demos, colleagues, students and the public."
15856899|NCT03987269|Behavioral|Narrative Video|The video will be formatted for a standard flat screen television. Participants will watch the video alone in a standard School of the Arts classroom.
15856900|NCT03987256|Other|Initial rehabilitation protocol|During 12 weeks, under kinesitherapist guidance, patients will perform daily eccentric stretching and strengthening of the ECRB and periscapular musculature, manual therapies, and kinesiotaping. They will also use orthotics after 6 weeks if kinesiotaping is not effective. At weeks 1-5, patients will undergo weekly ultrasound-guided focused shockwave therapy under the following protocol: 0,15- 0,30mJ/mm2 (the highest energy flux the patient can well tolerate), 1500 shocks at 5Hz at the origin of common extensor or flexor tendon.
15856901|NCT03987256|Procedure|Needling with PRP|"In case of failure of proper rehabilitation and shockwave therapy, patients will have a block of the radialis nerve just above the arcade of Frohse with 1 ml of procaine 2%. Then, a single needling of the ECRB enthesis (peppering technique) will be performed as follow: , ultrasound-guided, 25 repetitions with a 20 gauge needle. At the end of the procedure, the lesion will be fulfilled with PRP.
~Details of PRP preparation (ACP Arthrex): 15 ml of blood, no activators or anticoagulants, poor in white blood cells (the last mm of buffy coat above the red blood cells pellet is not collected).
~Excentric stretching and strengthening, as well as orthotics or kinesiotaping will be continued as long as symptoms persists during the 6 first months after the needling procedure."
15856902|NCT03987256|Procedure|Needling with saline solution|"In case of failure of proper rehabilitation and shockwave therapy, patients will have a block of the radialis nerve just above the arcade of Frohse with 1 ml of procaine 2%. Then, a single needling of the ECRB enthesis (peppering technique) will be performed as follow: , ultrasound-guided, 25 repetitions with a 20 gauge needle. At the end of the procedure, the lesion will be fulfilled with saline solution.
~Excentric stretching and strengthening, as well as orthotics or kinesiotaping will be continued as long as symptoms persists during the 6 first months after the needling procedure."
15856903|NCT03987243|Behavioral|Structured Pressure Ulcer Prevention Education|Structured education for performance weight shift maneuvers and pressure ulcer prevention will occur during the initial visit for each subject. The education method used aligns with principles of the social cognitive theory to facilitate learning. The purpose in providing the education is to ensure all of the participants receive uniform instruction in how to perform weight shifts and to facilitate understanding of the importance of completing them as a protective measure against pressure ulcer development. Because each participant will come into the study at varying levels of understanding about pressure ulcer risk and knowledge of how to complete weight shift maneuvers, the education component is critical to ensure all participants are provided with the same information in the same way.
15856904|NCT03987243|Other|Mobile Seat Interface Pressure Mapping System (IPM)|This mobile IPM system was designed to provide visual information about seat interface pressure distribution to compensate for lack of sensation on the sitting surface. This variable will be toggled on and off between the intervention and control phases of the study. The participants will have access to the visual feedback while learning how to complete weight shift maneuvers at the initial visit and then again at home during the intervention phases (weeks 2 and 4). During the control phases (weeks 1 and 3), they will not have access to the visual feedback from the pressure map
15856905|NCT03987230|Drug|Sensitive Eyes® Plus Saline Solution|Sensitive Eyes® Plus Saline Solution
15856906|NCT03987230|Other|Oust™ Demodex® Wipes™|Oust™ Demodex® Wipes™
15856907|NCT03987230|Other|I-LID N LASH PLUS® Eyelid Cleanser|I-LID N LASH PLUS® Eyelid Cleanser
15856908|NCT03987230|Other|Blephadex Lid Wipes|Blephadex Lid Wipes
15856909|NCT03987230|Other|Eye Cleanse Lid Wipes|Eye Cleanse Lid Wipes
15856910|NCT03987230|Other|Blephademodex|Blephademodex
15856911|NCT03987217|Dietary Supplement|Creatine Monohydrate|Given orally
15856912|NCT03987217|Behavioral|Exercise Intervention|Complete POWER resistance training program
15856913|NCT03987217|Other|Questionnaire Administration|Ancillary studies
15856914|NCT03987204|Drug|Ivabradine|Ivabradine will be started and titrated to heart rate slowing of 20 bpm or greater, or an increase in pacing.
15856915|NCT03987191|Drug|Multiple daily ijnection using Insulin Degludec and Insulin Aspart|Drug: Insulin Degludec and insulin Aspart Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
15856916|NCT03987178|Behavioral|Dunk|"If randomized to Dunk, the subject is asked to submerge his or her head in the hot tub at least up to brow level."
15856917|NCT03987178|Other|Exposure to Hot Tub|Subjects will be asked to sit in a hot tub for 15 minutes (with an individual timer).
15856918|NCT03987165|Other|Music Therapy|"Music therapy will be conducted once daily using a Song of Kin, a familiar song used to lull the infant to sleep. If no Song of Kin is provided, Twinkle Twinkle Little Star will be the default lullaby."
15856919|NCT03987152|Drug|Sirolimus|Daily intake of Sirolimus during Challenge and Rechallenge phase
15856923|NCT03987126|Dietary Supplement|Human Milk Oligosaccharides (HMO)|Sachet containing 10 grams of HMO
15856924|NCT03987126|Other|Placebo|Sachet manufactured to mimic 10g of HMO
15856925|NCT03987113|Other|Plasma concentration analysis during and after ex-vivo pulmonary reconditioning|The pulmonary endothelial dysfunction will be evaluated with plasma concentration of heparan sulphate, syndecan-1, endothelin-1 and i-NOS.
15856926|NCT03987087|Radiation|Radiation|"Thoracic intensity modulated radiation therapy (IMRT)
~+EGFR TKI combination Thoracenteral innfusion chemotherapy or Thoracenteral infusion chemotherapy combination Systemic chemotherapy"
15856927|NCT03987087|Drug|Chemotherapy|EGFR TKI combination Thoracenteral innfusion chemotherapy or Thoracenteral infusion chemotherapy combination Systemic chemotherapy
15856928|NCT03987074|Drug|Semaglutide|Solution administered subcutaneously with pre-filled PDS290 pen-injector once weekly
15856929|NCT03987074|Drug|Firsocostat|Tablets administered orally once daily
15856930|NCT03987074|Drug|Cilofexor|Tablets administered orally once daily
15856931|NCT03987061|Device|MOTIV BVS|MOTIVS BVS in below-the-knee artery disease
15857003|NCT03986411|Other|Phase 1: Qualitative interviews: Health care professionals|Semi-structured interviews of health care professionals to explore current management of urinary incontinence in the community
15864634|NCT03925090|Drug|Cisplatin+placebo|chemotherapy
15856932|NCT03987048|Other|Measure of short- and long-term mortality and analysis of independent predictors of short- and long-term mortality.|"Data were collected regarding medical background, medical condition and management, both at admission and during the ICU stay. These included demographics, clinical, biological and therapeutic data.
~Outcome at ICU discharge and at one year were also recorded."
15856933|NCT03987035|Device|BeGraft Peripheral (BGP) Stent Graft System as bridging stent|BGP Stent Graft System as bridging stent
15856934|NCT03987022|Drug|Ketorolac|Use of non-steroidal anti-inflammatory drug for pain control post operatively
15856935|NCT03987022|Drug|Opioids|Use of narcotic for pain control post operatively
15856936|NCT03987022|Other|Ice Packs|Placement of Ice packs on surgical sites post operatively
15856937|NCT03987022|Drug|Tylenol|Use of pain medication post operatively
15856938|NCT03987022|Drug|Motrin|Use of non-steroidal anti-inflammatory drug for pain control post operatively
15856939|NCT03987022|Drug|dilaudid|Use of narcotic for pain control post operatively
15856940|NCT03987009|Device|Without RAMP and without video|Intubation with video-laryngoscope McGrath without use of the video feature and patient positioning without RAMP device
15856941|NCT03987009|Device|With RAMP and with video|Intubation with video-laryngoscope McGrath with use of the video feature and patient positioning with RAMP device
15856942|NCT03987009|Device|Without RAMP and with video|Intubation with video-laryngoscope McGrath with use of the video feature and patient positioning without RAMP device
15856943|NCT03987009|Device|With RAMP and without video|Intubation with video-laryngoscope McGrath without use of the video feature and patient positioning with RAMP device
15856944|NCT03986996|Drug|amoxicillin, metronidazole and doxycycline|antibiotics: Patient weight 30-50 kg Patient weight > 50 kg Tetracycline 50 mg X 2 Day X 2 weeks 100 mg X 2 Day X 2 weeks Amoxicillin 750 mg X 2 Day X 2 weeks 750 mg X 2 Day X 2 weeks Metronidazole 250 mg X 2 Day X 2 weeks 375 mg X 2 Day X 2 weeks
15856945|NCT03986996|Drug|amoxicillin and doxycyclin|antibiotics: Patient weight 30-50 kg Patient weight > 50 kg Tetracycline 50 mg X 2 Day X 2 weeks 100 mg X 2 Day X 2 weeks Amoxicillin 750 mg X 2 Day X 2 weeks 750 mg X 2 Day X 2 weeks
15856946|NCT03986983|Device|Shockwave therapy|Shockwave therapy protocol - The shockwave therapy protocol was performed in the prone position. The application was radial shockwave with 3,5bar, 15Hz of frequency and 3000 impulses.
15856947|NCT03986983|Other|Aerobic exercise|Aerobic exercise protocol - 30 minutes of aerobic moderate-intensity exercise (40% of reserve heart rate) using Karvonen´s formula, performed on a step.
15856948|NCT03986970|Drug|Tenofovir|Pre-exposure prophylaxis
15856949|NCT03986957|Other|No interventions|No interventions - observational study
15856950|NCT03986944|Drug|75 mg linzagolix tablet|For oral administration once daily
15856951|NCT03986944|Drug|200 mg linzagolix tablet|For oral administration once daily
15856952|NCT03986944|Drug|Add-back capsule (E2 1 mg / NETA 0.5 mg)|For oral administration once daily
15856953|NCT03986944|Drug|Placebo tablet to match 75 mg linzagolix tablet|For oral administration once daily
15856954|NCT03986944|Drug|Placebo tablet to match 200 mg linzagolix tablet|For oral administration once daily
15856955|NCT03986944|Drug|Placebo capsule to match Add-back capsule|For oral administration once daily
15856956|NCT03986931|Other|Experimental: Pharmacist-Bidirectional Texting Group|The goal of this intervention is to determine if bidirectional texting and pharmacist monitoring will improve blood pressure control.
15856957|NCT03986931|Other|Active Comparator: Control Group|This group will receive bidirectional texting, but no pharmacist monitoring.
15856958|NCT03986918|Device|Routine Total Hip Arthroplasty|Patients undergoing routine total hip arthroplasty will receive surveys regarding survivorship and outcomes.
15856959|NCT03986905|Drug|Scopolamine Nasal Gel|All subjects will receive both a patch and nasal gel: DPI-386 Nasal Gel + placebo patch, placebo nasal gel + placebo patch, or placebo nasal gel + TDS patch.
15856960|NCT03986905|Other|Placebo|placebo nasal gel + placebo patch
15856961|NCT03986892|Behavioral|Physical Activity|Physical Activity
15856962|NCT03986866|Other|Video|A 5 minute video on the risks and benefits of opioids, alternative methods to reduce pain, and the proper handling and storage of opioids will be shown.
15856963|NCT03986853|Procedure|Blood sampling|Blood sampling under general anesthesia
15856964|NCT03986840|Other|Exercise training|A multicomponent exercise program
15856965|NCT03986827|Behavioral|Cool Kids Anxiety Program - Social Enhanced|Specific G-CBT intervention for adolescents with social anxiety disorder
15856966|NCT03986827|Behavioral|Cool Kids Anxiety Program|Generic G-CBT intervention for adolescents with anxiety disorders
15856967|NCT03986801|Other|pharmaceutical interview|pharmaceutical interview at the end of hospitalization
15856968|NCT03986788|Other|Weightlessness|Volunteers will be studied during parabolic flight. Cerebral blood flow will be measured in different part of the brain during weightlessness ans compared to 1g and hypergravity measurements.
15856969|NCT03986775|Dietary Supplement|isomaltulose|replacement of sucrose with low-glycemic isomaltulose
15856970|NCT03986775|Dietary Supplement|sucrose|conventional beverage with sucrose
15856971|NCT03986762|Drug|Clavulanic Acid|~10 days of Clavulanic Acid
15856972|NCT03986749|Procedure|Doppler ultrasonography after bursa augmentation|Dynamic ultrasound examination with Grading of blood vessels using the modified Ohberg Score in the longitudinal scan in dynamic ultrasound of the rotator cuff tendon - primary to surgery and 3 weeks later.
15856973|NCT03986736|Diagnostic Test|Laboratory analysis - upon admission|Laboratory analysis will be performed upon admission of the patient to the hospital. Levels of the following parameters will be determined: HMGB-1, sCK, sMb, serum NGAL, and urine NGAL
15856974|NCT03986736|Diagnostic Test|Laboratory analysis - 24 hours after injury|Laboratory analysis will be performed upon admission of the patient to the hospital. Levels of the following parameters will be determined: sCK, sMb, serum NGAL, and urine NGAL
15856975|NCT03986697|Drug|Biktarvy|Fixed dose combination preparation containing bictegravir, tenofovir alafenamide and emtricitabine
15856976|NCT03986671|Device|Transmembrane EMG Oropharynx Probe|Examination of the electromyographic signal from oropharyngeal muscles obtained using an investigational transmembrane sensor attached to a rigid probe and an FDA-approved very fine concentric needle electrode (Ambu Neuroline 25 mm x 30G).
15866241|NCT03911973|Drug|Talazoparib|.75-1.00mg
15856979|NCT03986632|Behavioral|Tundra Gifts|Tundra Gifts is a home-focused intervention delivered by community health workers (CHW) that focuses on promoting healthy eating and an active lifestyle among 3-5 year olds through family and community partnerships. Primary caregivers will attend monthly interactive education session, receive a monthly gift basket that includes resources and supplies to support behavior change at home and receive ongoing social support through a Facebook site.
15856980|NCT03986606|Biological|PSB205|PSB205 is a bi-functional product that has been engineered to contain two unique monoclonal antibodies.
15856981|NCT03986593|Device|cryoablation|cryoablation of bone metastases by cone beam-CT image-guidance
15856982|NCT03986580|Device|Annular closure device|Annular closure, following limited discectomy procedure at a single LS level between L4 and S1
15856983|NCT03986567|Behavioral|gamification for partner notification among youngsters|"Design a web based tool adapted to Mobile phones for partner notification of STI among youngsters 16 to 24 years old and evaluate its role in increasing the patient referral partner notification"
15856984|NCT03986554|Procedure|Videofluoroscopic swallow study|The Swallowing Systems Core laboratory is fully equipped to perform VFSS with a C-arm (OEC 9900) that is dedicated solely for research purposes. VFSS recordings will be kept to a minimum and only turned on during the execution of each swallow in all sequences. Video recording and images captured during the VFSS will be synced and saved to a secure server for data analysis. VFSS allows for time-synced, frame-by-frame data analysis for the specific measures taken during swallowing tasks. The physiological swallowing measures (temporal and kinematic movement of the hyolaryngeal complex during swallowing) cannot be visualized with any other technique. Patients will swallow only water. Aspiration (bolus into trachea) is not expected to occur during this study given that the individuals recruited will have no prior history of disease or disorder, and aspiration is uncommon in healthy individuals.
15856985|NCT03986554|Procedure|pharyngeal High Resolution Manometry|This procedure will only take place once during sequence 2 of the randomization B session. If desired, a small amount (< 0.5 mL) of topical 2% viscous lidocaine hydrochloride will be applied to the participant's nostril of choice prior to catheter insertion. The catheter will be placed through the nasal passage, oropharynx, and hypopharynx to the esophagus. Correct catheter placement will be verified with VFSS. With the catheter in place, the subject will perform 10 swallows of 10ml and is expected to take approximately 2.5 minutes. The catheter will then be removed and the subject will move on to sequence 3. Individuals have the option to decline this procedure if it is uncomfortable or difficult to tolerate.
15856986|NCT03986541|Diagnostic Test|Immunohistochemistry|Assessment of tumour amphiregulin, epiregulin and EGFR expression by immunohistochemistry.
15856987|NCT03986528|Drug|Kanglaite Injection+Chemotherapy|Patients will receive investigator's choice of paclitaxel (135mg/m2 by IV infusion on Day 1 of each 21-28 day cycle) or pemetrexed (500mg/m2 by IV infusion on Day 1 of each 21-28 day cycle) or gemcitabine(1000mg/m2 by IV infusion on Days 1,8 of each 21-28 day cycle) PLUS cisplatin (75mg/m2 by IV infusion on Days 1 to 3 of each 21-28 day cycle) or carboplatin (AUC 6 by IV infusion on Days 1 of each 21-28 day cycle) according pathologic types. Patients with CR, PR, or SD after 4-6 cycles of platinum-based double chemotherapy regimens will receive non-platinum single-agent chemotherapy. The patients will also receive Kanglaite injection 200ml by IV infusion per day continuously for 14 days, commencing on the first day of chemotherapy.
15856988|NCT03986528|Drug|Chemotherapy|Patients will receive investigator's choice of paclitaxel (135mg/m2 by IV infusion on Day 1 of each 21-28 day cycle) or pemetrexed (500mg/m2 by IV infusion on Day 1 of each 21-28 day cycle) or gemcitabine(1000mg/m2 by IV infusion on Days 1,8 of each 21-28 day cycle) PLUS cisplatin (75mg/m2 by IV infusion on Days 1 to 3 of each 21-28 day cycle) or carboplatin (AUC 6 by IV infusion on Days 1 of each 21-28 day cycle) according pathologic types. Patients with CR, PR, or SD after 4-6 cycles of platinum-based double chemotherapy regimens will receive non-platinum single-agent chemotherapy.
15856989|NCT03986515|Drug|apatinib plus SHR-1210|apatinib 250mg qd, 3-5 days later SHR-1210 200mg q3w
15856990|NCT03986502|Other|Media Intervention|Watch web-based financial literacy video
15856991|NCT03986502|Other|Informational Intervention|Receive information on financial counseling and medical cost assistance
15856992|NCT03986502|Other|Best Practice|Utilize usual clinic procedures and clinic or community-based financial resources
15856993|NCT03986502|Other|Questionnaire Administration|Ancillary studies
15856994|NCT03986502|Other|Quality-of-Life Assessment|Ancillary studies
15856995|NCT03986489|Behavioral|Mindfulness-based dance/movement therapy (M-DMT)|M-DMT includes benefits of physical activity, group psychotherapy, mindfulness training, and an art-based intervention in a unified practice. Each online session focuses on different psycho-educational topics about chronic low back pain management and links these topics with specific M-DMT activities that incorporate mindfulness-based principles and techniques.
15856996|NCT03986489|Behavioral|Chronic pain social support group|"The therapist will facilitate online open group discussions about participants' experiences with or reactions to the topic of discussion and will promote empathy among group members. The therapist will use client-centered, reflective listening techniques but will not prescribe any specific recommendations for change.
~Each week, SSG participants will receive emails with brief information about the topic discussed during the group session."
15856997|NCT03986476|Dietary Supplement|Probiotics|5x10^8 colony forming units (CFU) of each probiotic strain, two capsules per day over six weeks
15856998|NCT03986476|Other|Placebo|Similar in shape and taste to intervention capsules but without the probiotic components, two capsules per day over six weeks
15856999|NCT03986463|Other|Circulating tumour DNA (ctDNA)|Circulating tumour DNA (ctDNA) will be isolated from blood samples
15857000|NCT03986450|Other|Enhanced recovery after surge(ERAS) protocol|"The components of ERAS multidisciplinary pathway concerning preoperative, operative, and postoperative period are as follows:
~Preoperative care:
~Counseling before hospital admission Fluid, and carbohydrate loading Avoiding prolongation of the fasting period Avoiding bowel preparation or its application only in selective cases Application of antibiotic prophylaxis Application of thromboprophylaxis
~Perioperative care:
~Use of short-acting anesthetic agents Application of midthoracic, epidural anesthesia/analgesia Refraining from using drains Refraining from salt, and water overload Maintenance of normothermia
~Postoperative care:
~Application of midthoracic, epidural anesthesia/analgesia Prevention of nausea, and vomiting Refraining from salt, and water overload Earlier removal of catheters Initiation of oral intake at an early period Use of nonopioid oral analgesics/NSAIDs Early mobilization"
15857004|NCT03986411|Other|Phase 2: Physiotherapy for urinary incontinence|Tailored physiotherapy assessment and management for athletic women who self-report urinary incontinence
15857005|NCT03986411|Other|Phase 3: Qualitative Interviews: Participants|Semi-structured interviews of a purposeful selection of the participants from Phase 2 to explore reaction to the recruitment process and the intervention
15857006|NCT03986398|Other|Infection prophylaxis|Infection prophylaxis with Urell®, cranberry fruit juice extract (vaccinium macrocarpon)
15857007|NCT03986385|Drug|Apatinib Capecitabine Oxaliplatin|apatinib 250mg qd po q4w Capecitabine 1000mg/m2 bid d1-14，Oxaliplatin 130 mg/m2 Ivgtt d1 q3w
15857008|NCT03986385|Drug|Capecitabine Oxaliplatin|Preoperative: Capecitabine 1000mg/m2 bid d1-14，Oxaliplatin 130 mg/m2 Ivgtt d1 q3w
15857009|NCT03986372|Biological|Platlet-rich plasma|Multiple Platlet-rich plasma injection.
15857010|NCT03986359|Device|low energy extracorporeal shockwave therapy|Low-intensity extracorporeal shockwave therapy (LI-ESWT) was proved to be useful in various medical conditions; for example, neovascularization in myocardial ischemia, nonhealing wounds, ED and chronic pelvic pain syndrome
15857011|NCT03986346|Device|pulsed dye laser|The scar will receive PDL 585 nm using a 7 mm spot size. First treatment will be within 1 year post injury.
15857012|NCT03986346|Other|standardized care|the scar will receive standardized care such as scar massage.
15857013|NCT03986320|Device|Keeogo™ Dermoskeleton|This device is intended for use in rehabilitation institutions to assist individuals with hemiparesis due to stroke who are able to stand and initiate a step in performing ambulatory functions.
15857014|NCT03986307|Dietary Supplement|Omega-3 polyunsaturated fatty acid supplementation|Daily supplementation with omega-3 capsules (daily for 14 weeks). Each day: 3 capsules of 1.1g
15857015|NCT03986307|Other|Resistance exercise|Resistance exercise training in both supplementation conditions (3 times per week for 12 weeks).
15857016|NCT03986307|Dietary Supplement|Placebo - appearance-matched oil supplementation|Daily supplementation with placebo capsules (daily for 14 weeks). Each day: 3 capsules of 1.1g
15857017|NCT03986294|Drug|S1 + Nal-IRI|S-1 will be given for 14 consecutive days, twice daily, followed by 2 weeks rest. Nal-IRI will be administered as an intravenous infusion on day 1 and 15. Courses of treatment will be repeated every 4 weeks.
15857018|NCT03986294|Drug|Nal-IRI+Leucovorin+5-FU|Nal-IRI 80 mg/m2 will be administered first, followed by LV 400 mg/m2, followed by 5-FU 2400 mg/m2 as an IV infusion over 46-hours on days 1-3. Each cycle consists of 14 days. Courses of treatment will be repeated every 2 weeks.
15857019|NCT03986281|Other|Omron Wearable Device|Omron wearable device compared to arterial line readings
15857020|NCT03986281|Other|Standard Arterial Line|Omron wearable device compared to arterial line readings
15857021|NCT03986268|Drug|Vit D|The aim of this study is investigating pathologic response to neoadjuvant therapy if we give replacement therapy with vitamin D3 50.000 IU weekly dosage concurrent with chemotherapy in breast cancer patients.
15857022|NCT03986255|Procedure|Lumbar Puncture|"The participant is placed lateral or sitting position. Fluoroscopy may be used to guide sampling. Full aseptic technique is used throughout.
~The skin is prepared with either 2% chlorhexidine/70% alcohol or iodine. 1% lidocaine is used for skin local anesthesia an entry point is identified, this may be done using fluoroscopy. This will be at the lowest intervertebral foramina interspace to minimize the risk of spinal cord injury. A small amount to head up tilt will be allowed to optimize CSF flow.
~Sampling is done using a needle through needle technique. An epidural needle is used to identify the epidural space using loss of resistance to saline technique. A spinal needle (26G) is then passed through the epidural needle into the subarachnoid space. Correct entry is noted once CSF is noted in the needle hub and 5 ml taken. This sample is then sent off for analysis.
~Once the CSF is sampled, the needle is removed and pressure applied to the skin entry point."
15857023|NCT03986242|Device|rolling|use non- vibration rolling and the total time is 20 minutes.
15857024|NCT03986242|Device|Vibration rolling|use Vibration rolling the vibration frequency is 28 Hz, and the total time is 20 minutes.
15857025|NCT03986242|Other|static stretching|static stretching and the total time is 20 minutes.
15857026|NCT03986229|Other|"Evaluate the variation in the travel speed of the center of pressure with and without compression garments."|"Each evaluation will be done according to the following protocol:
~Evaluation of the pain
~Berg test
~One test per condition starting with open eyes
~Standardized instructions:
~Break about 15 minutes (wash-out) between each test.
~Both conditions will be tested on the same day.
~Evaluation in an environment free from visual and audible interference."
15857027|NCT03986216|Device|ReIn-Hand device assisted home-based practice|Practice reach-grasp-retrieve-release at home with the aid of ReIn-hand device
15857028|NCT03986203|Device|Spry Belt|The Spry Belt delivers energy to the user that may help prevent bone loss. Participants will wear the device for 30 minutes a day, 5 days a week for one year. The active and sham devices are identical except for the specific energy that is delivered to the user.
15857029|NCT03986190|Behavioral|Healthy Juntos|"Parent-adolescent dyads will log in to a secured website for a total of eight weeks. The intervention will be delivered primarily through smartphones and will include didactic content on healthy lifestyle behaviors (for parents/adolescents), family behavior change content for setting weekly goals and self-monitoring health behaviors (for parents/adolescents), and positive parenting content (for parents only), all of which were developed in accordance with participant feedback based on formative intervention development work. In addition, and to increase participant compliance/reduce attrition often observed in digital health interventions, human support (supportive accountability) will be provided. Specifically, each family will be assigned a coach who will use video conferencing software or phone to engage in weekly 15-30 minute conversations with parents regarding their family's progress throughout the intervention period."
15857030|NCT03986177|Behavioral|Self-management Intervention Package|"Children will receive basic asthma education, based on the National Heart, Lung, and Blood Institute A Breath of Life asthma education program. Children/caregivers in the intervention arm will also be assigned a designated nurse case manager who will provide home visits and be available via text message and phone-based support throughout follow-up. Intervention components:
~Interactive education and support on use of an asthma action plan
~Locally adapted patient-provider communication tool
~Child-oriented educational materials in comic book format
~Modeling and hands-on practice of inhaler technique (written instructions, in person, video)
~Education regarding environmental trigger abatement
~Patient navigation, home visits, and goal setting support from nurse manager"
15857031|NCT03986164|Device|Guided surgery with bovine spongious bone substitute|"A minimally traumatic extraction will be performed aiming at the preservation of tissue integrity. After this step, milling will be performed using a sequence of guides and cutters recommended by the Raptor Implacil / Bioparts (Implacil De Bortoli) system manufacturer for implant installation (Cone Morse 3.5mm from 11-13mm Implacil De Bortoli) in computer-guided surgeries.
~In the spaces between the implant and the buccal bone plate will be filled with xenogene biomaterial (Geistlich Bio-Oss 0.25-1mm). Immediately after implant installation, the prosthetic component (Smart Line, Trunnion CM 3.5mm - T 1.5-3.5mm, height 4mm - Implacil De Bortoli) will be placed.
~If necessary, the sutures of the surgical procedures will be performed with polygalactin 5.0 (Vycril Rapid®, Jonhson's Jonhson, São José dos Campos) and will be removed after 7 days."
15857032|NCT03986164|Device|Conventional surgery with bovine spongious bone substitute|The sequence of cutters recommended by the manufacturer for this type of surgery and installation of the same type of implant (Cone Morse due cone 3.5mm) will be adopted. The perforations of the collar for future insertion of the implants will be performed aiming the installation of the implants with its platform installed with sub-crestal position. The implant should be installed along the palatine wall to obtain primary stability, at the center of the mesio-distal width predetermined by the final restoration, with a minimum distance of 2 mm from the adjacent tooth, and 3 mm from the free gingival margin, becoming slightly palatinate (Kan et al, 2018). Immediately after installation, the prosthetic component (Smart Line, Trunnion CM 3.5mm - T 1.5-3.5mm, height 4mm) will be placed. If necessary, the sutures of the surgical procedures will be performed with polygalactin 5.0 (Vycril Rapid®, Jonhson's Jonhson, São José dos Campos) and will be removed after 7 days.
15857033|NCT03986151|Procedure|Coronary angiography +/- percutaneous coronary intervention|Comparison of the conventional radial approach with the distal radial approach (anatomical snuffbox)
15857034|NCT03986138|Drug|gadopiclenol|Single intravenous bolus injection
15857035|NCT03986138|Drug|Gadobutrol 1 MMOLE/ML Intravenous Solution|Single intravenous bolus injection
15857036|NCT03986125|Behavioral|Emotional Awareness & Expression Therapy|emotion-focused
15857037|NCT03986125|Behavioral|Mindfulness Meditation Training|meditation training and practice
15857038|NCT03986112|Biological|carotid sonography and inferior vena cava sonography|Carotid and venous ultrasonography is performed in a comfortable state. Corrected blood flow after carotid ultrasound and carotid artery blood flow rate were measured. After inferior vena cava sonography, the collapsibility Index by measuring the largest and smallest diameter during the respiratory cycle will be obtained. Propofol 2 mg / kg is administered and remifentanil is maintained at 4.0 ng / mL using the Target Control System. Blood pressure and heart rate are measured at prior to induction, 1 minute after induction, immediately after intubation, and at 1, 3, 5, 7 and 10 minutes after intubation. Post-induction hypotension is considered as a decrease of 20% or more of baseline blood pressure or a mean arterial blood pressure of less than 60 mmHg. In the event of hypotension in accordance with the above definition, repeated administration of ephedrine 4 mg or phenylephrine 50 mcg is used.
15857039|NCT03986099|Diagnostic Test|Monitoring virus load|Near point of care
15857040|NCT03986086|Drug|MPH966|RP2D tablet
15857041|NCT03986086|Drug|Placebo|MPH966 placebo table
15857042|NCT03986073|Drug|TQ-F3083 capsule 10 mg|Subjects in the low dose group administrated TQ-F3083 capsule 10mg, once daily for 12 weeks.
15857043|NCT03986073|Drug|TQ-F3083 capsule 20 mg|Subjects in the high dose group administrated TQ-F3083 capsule 20 mg, once daily for 12 weeks.
15857044|NCT03986073|Drug|TQ-F3083 blank analog capsule|Subjects administrated one TQ-F3083 blank analog capsule orally, once daily for 12 weeks.
15857045|NCT03986073|Drug|TQ-F3083 blank analog capsule|Subjects administrated two TQ-F3083 blank analog capsules orally, once daily for 12 weeks.
15857046|NCT03986073|Drug|Linagliptin blank analog tablet|Subjects administrated one Linagliptin blank analog tablet orally, once daily for 12 weeks.
15857047|NCT03986073|Drug|Linagliptin tablet|Subjects in the positive drug control group administrated one Linagliptin tablet orally, once daily for 12 weeks.
15857048|NCT03986047|Device|Thermal care|Wearing of a light elastic lower back heating wrap, which heats up to 40°C within 30 minutes and maintains this temperature continuously for 8 hours. Heat wrap will be worn during the day for 8 hours on 7 consecutive days.
15857049|NCT03986047|Other|Exercises|In addition of exercises performed with the physiotherapist at the first session, exercises will be performed at home five times over the next 7 days, for approximately 30 minutes each performing day. Three different categories of exercises will be given: 1) Functional activities exposure (sitting, sit-to-stand, lifting, bending, etc.); 2) cognitive contraction of trunk muscles and basic trunk motor control exercises; 3) mobility of the lumbar spine and preferential direction of movement. Exercises will be chosen and adapted for each participant by a physiotherapist, in function of pain presentation and intensity, and response to exercises.
15857050|NCT03986047|Device|Sham|The same lower back wrap as the Thermal care group will be used, but cooled down to room temperature (opened in advance). The wrap will be worn following the same parameters (duration, frequency) than the Thermal care group.
15857051|NCT03986047|Behavioral|Education for the management of acute low back pain|Participants will receive education on the management of acute low back pain by a physiotherapist . The main topics addressed will be patient reassurance, staying active, avoiding bed rest, activity modification, and sitting and bed postures/transfer. Participants will received a document that details advices covered during the session and the physiotherapist will answer any questions.
15857052|NCT03986034|Drug|During Venetoclax|Patients with CLL/SLL will enroll on the study. Subjects will be treated at the NIH Clinical Center for the duration of the ramp-up phase of venetoclax. After the ramp-up phase is complete, subjects will be transitioned to the care of their local hematologist/oncologist and receive venetoclax monotherapy or in combination with other agent(s) at the discretion of the treating oncologist. Subjects will have the option to follow-up at the NIH every 6 months (from initiation of venetoclax) and at (suspected) progression.
15857053|NCT03986008|Drug|Benaglutide|The treatment of Benaglutide lasted three months.During the first week: 0.1mg per day;During the second week: 0.14mg per day; From third week onwards, 0.2mg per day.
15857054|NCT03986008|Drug|Liraglutide|The treatment of Liraglutide lasted three months.During the first week: 0.6mg per day;During the second week: 1.2mg per day; From third week onwards, 1.8mg per day.
15857116|NCT03985488|Radiation|Radiation exposure|Radiation exposure via Eview Fluoroscopy machine.
15857055|NCT03985995|Drug|CBD 800 mg p.o|cannabidiol solution 100 mg/ml 8 ml in single-dose containers for per os administration. After a washout period of at least two weeks, the treatment group will be receiving a single-dose of the placebo solution 8 ml as a second intervention.
15857056|NCT03985995|Drug|Placebo p.o|single dose of oral placebo solution 8 ml matched to the IMP. After a washout period of at least two weeks, the control intervention group will be receiving the cannabidiol solution 100 mg/ml 8 ml as a second intervention.
15857057|NCT03985982|Drug|Botulinum Toxin A|Injection, 20 Units divided in five 0.1 mL i.m injections into the glabellar area
15857058|NCT03985982|Drug|Placebo|injection, sodium chloride 0.9 % divided in five 0.1 mL i.m injections into the glabellar area
15857059|NCT03985969|Drug|elafibranor|Elafibranor 120mg is a coated tablet for oral administration
15857060|NCT03985969|Drug|CHRONO-INDOCID|CHRONO-INDOCID 75mg is a capsule for bis in die (bid) oral administration
15857061|NCT03985943|Drug|Placebo|Placebo
15857062|NCT03985943|Drug|Nemolizumab|Nemolizumab
15857063|NCT03985930|Other|Distraction with virtual reality or video projection|Distraction content delivered through virtual reality goggles or video projection.
15857064|NCT03985917|Other|Singing Group Intervention Program|Each session will start with (1) relaxation, vocal warm-up and breething exercises; (2) vocal technique training; (3) memorization and interpretation of music and lyrics; (4) session breaks of 20 minutes for socialization; (5) preparation of a final choir show; (6) vocal tuning tests.
15857065|NCT03985917|Other|Alternative Social and Leisure Activities|Day care centers provide social and leisure activities opportunities for older adults. The control group is free to enroll in these activities.
15857066|NCT03985904|Other|ART THERAPY|ART THERAPY: Nursing Interventions Classification = 4330 Weekly group intervention carried out by a mental health nurse specialist, a mental health peer support, a museum educator and a social monitor.
15857067|NCT03985891|Drug|Anti-PD-1 Monoclonal Antibody JS001|Anti-PD-1 monoclonal antibody combined with chemotherapy in patients with locally advanced colon cancer (perioperative treatment)
15857068|NCT03985891|Drug|Chemotherapy|Folfox
15857069|NCT03985878|Drug|Eteplirsen|Eteplirsen IV infusion once weekly.
15857070|NCT03985865|Drug|Intragastric quinine hydrochloride|A nasogastric feeding tube was positioned into the stomach, and checked with a pH strip. 10 µmol of quinine hydrochloride per kg body weight was administrated into the stomach.
15857071|NCT03985865|Drug|Intragastric denatonium benzoate|A nasogastric feeding tube was positioned into the stomach, and checked with a pH strip. 1 µmol of denatonium benzoate per kg body weight was administrated into the stomach.
15857072|NCT03985865|Drug|Intragastric placebo|A nasogastric feeding tube was positioned into the stomach, and checked with a pH strip. 0.1 ml of water (placebo) per kg body weight was administrated into the stomach.
15857073|NCT03985865|Drug|Intraduodenal quinine hydrochloride|A nasogastric feeding tube was positioned into the duodenum, and checked with fluoroscopy. 10 µmol of quinine hydrochloride per kg body weight was administrated into the duodenum.
15857074|NCT03985865|Drug|Intraduodenal denatonium benzoate|A nasogastric feeding tube was positioned into the duodenum, and checked with fluoroscopy. 1 µmol of denatonium benzoate per kg body weight was administrated into the duodenum.
15857075|NCT03985865|Drug|Intraduodenal placebo|A nasogastric feeding tube was positioned into the duodenum, and checked with fluoroscopy. 0.1 ml of water (placebo) per kg body weight was administrated into the duodenum.
15857076|NCT03985852|Other|Patient Directed Standard of Care|The pre-test genetic counseling visit will be conducted through access to an automated genetics education assistant accessed through the patient portal. The automated approach will address all the components of the pre-test counseling and contains content designed by the genetic counselors at the University of Utah and NYU. Patients will have the option to contact genetic counselors through the patient portal, by phone, or in person but this will not be required. All results will be reviewed by a genetic counselor. Negative results will be returned by the automated genetics education assistant. Genetic counselors will return results for pathogenic variants and variants of uncertain significance via phone.
15857080|NCT03985826|Other|Diagnosis of and treatment for Acute lymphoblastic leukaemia in childhood|The cohort of ALL survivors has all been diagnosed and treated for ALL in childhood
15857081|NCT03985813|Behavioral|Screening Wizard|Screening Wizard is a decision support tool to guide the primary care provider to make a referral that reflects patient clinical needs and patient and parental treatment preferences and perceived barriers to treatment.
15857082|NCT03985800|Other|TEAM|TEAM incorporates team-based care with traditional in-person clinic visits. The care team includes a gastroenterologist, nurse practitioner, nutritionist, social worker/behavioral health specialist, and a psychologist or psychiatrist.
15857083|NCT03985800|Other|TECH|TECH uses team-based care similar to TEAM, but in-person care is substituted with telemedicine (i.e., video visits and consultations) and digital behavioral health tools.
15857084|NCT03985787|Behavioral|Resistance Training|12-weeks of a full body resistance training intervention. Intervention will consist of 4 training sessions per week that are approximately 45-minutes in length. Two days will be upper body training and 2 days lower body
15857117|NCT03985475|Other|skin sample|For each person included in the study, skin sampling performed as part of the medical management of skin infections will be performed, associated with the contralateral healthy skin sampling.
15857118|NCT03985462|Biological|very small embryonic-like stem cell|Mononuclear cells were collected from peripheral blood of each patient using a machine, VSELs were isolated, and each group was injected according to different numbers after activation
15857085|NCT03985774|Procedure|Transcarotid revascularization|The ENROUTE Transcarotid Neuroprotection System (NPS) has received CE Mark and is commercially available in the European Union. The ENROUTE Transcarotid NPS may be used in conjunction with carotid artery stent approved for revascularization in patients with carotid disease The ENROUTE Transcarotid Neuroprotection System is intended to provide transcarotid vascular access, introduction of diagnostic agents and therapeutic devices, and embolic protection during carotid artery angioplasty and stenting procedures for patients diagnosed with carotid artery stenosis
15857086|NCT03985761|Behavioral|Home Telerehabilitation using HoVRS|The Home Virtual Rehabilitation System (HoVRS) integrates a Leap Motion controller, a passive arm support and a suite of custom designed hand rehabilitation simulations. The Leap Motion provides camera based measurement of finger joint positions, allowing for integrated virtual arm and finger training. If the patient's arm is severely impaired, a forearm orthosis that counter-balances gravity to provide graded support to the arm during activity is issued to the subject. In this study, we utilize 3 task-based simulations that train hand manipulation and arm transport. One simulation trains hand opening integrated with pronation and supination, a second trains wrist movement, by presenting targets that subjects navigate a plane over and around buildings to collect, a third simulation, trains shoulder and elbow disassociation in a horizontal plane integrated with hand opening.
15857087|NCT03985748|Device|BAN|Inhaled bronchodilators will be delivered using an AeroEclipse® II Breath Actuated Nebuliz (BAN)
15857088|NCT03985748|Device|SN|Inhaled bronchodilators will be delivered using a Standard Nebulizer (SN)
15857089|NCT03985735|Drug|General anesthesia|For maintenance of propofol anesthesia, total intravenous anesthesia was administered by using propofol (Fresenius Kabi, Austria GmbH) at a plasma target concentration (Marsh pharmacokinetic model software) of 2.5-4 μg/ml. Remifentanil (0.2-0.5 μg/kg/min) was given to all patients during the operation. Additional cisatracurium （0.05 mg/kg）and fentanyl (30-50 μg at the end of surgery) were used as needed, in accordance with the clinical requirements.
15857090|NCT03985722|Drug|Olaratumab and Trabectedin|"Dose-escalation levels:
~LEVEL -1: Olaratumab 15 mg/Kg D1 and D8 + Trabectedin 0.9 mg/m2 D1 This is a security level in case level 0 causes DLT.
~LEVEL 0*: Olaratumab 15 mg/Kg D1 and D8 + Trabectedin 1.1 mg/m2 D1.
~* Dose starting level is 0."
15857091|NCT03985722|Drug|Olaratumab and Trabectedin|"Dose-escalation levels:
~LEVEL 2: Olaratumab 15 mg/Kg D1 and D8 + Trabectedin 1.5 mg/m2 D1"
15857092|NCT03985722|Drug|Olaratumab and Trabectedin|"Dose-escalation levels:
~LEVEL 3**: Olaratumab 20 mg/kg C1D1 and C1D8 (induction) + Trabectedin 1.5 mg/m2 D1 and Olaratumab 15 mg/kg D1 and D8 (maintenance) + Trabectedin 1.5 mg/m2 D1
~**In the LEVEL 3 Olaratumab dose of 20 mg/kg will be considered only for the first 2 doses (as induction doses, cycle 1 days 1 and 8)) and then, the maintenance dose will be 15 mg/m2 for the rest of cycles."
15857093|NCT03985709|Other|Probiotic product|Probiotic (Lactobacillus casei) once daily taken by 3 months.
15857094|NCT03985696|Other|blood sample|1 blood volume (5-7 ml EDTA)
15857095|NCT03985683|Other|agility tests|In control group athletes will perform T-Test, Illinois agility test, 30 meter run test and Agility Compass drill test, before and after 6 days of intervention.
15857096|NCT03985683|Dietary Supplement|Nutritional Interventional|Athletes were given 50 % carbohydrate in first 3 days and 70 % in next 3 days respectively.T-Test, Illinois agility test, 30 meter run test and Agility Compass drill test, before and after 6 days of intervention.
15857097|NCT03985670|Drug|teripalimab plus chemotherapy|teripalimab 240mg d1 paclitaxel 150mg/m2 d1 cisplatin 70mg/m2 d1
15857098|NCT03985670|Drug|chemotherapy plus teripalimab|paclitaxel 150mg/m2 d1 cisplatin 70mg/m2 d1 teripalimab 240mg d3
15857099|NCT03985657|Device|CPAP|Continuous positive airway pressure (CPAP). Room air at pressures between 6-8 centimeters of water (cmH2O) delivered via heated humidified tubing and a nasal mask.
15857100|NCT03985631|Other|Rehabilitation intervention|Rehabilitation sessions based on Tai Chi through telerehabilitation
15857101|NCT03985618|Procedure|Caesarean section|Planned pre-labour Caesarean section at 38-40 weeks. For patients planning Caesarean Section, surgical planning, precise timing and method of Caesarean section is at the discretion of the most responsible care provider, as per local procedures.
15857102|NCT03985618|Procedure|Induction of Labour|Planned induction of labour at 38-40 weeks. For patients planning induction of labour, precise timing and method of induction of labour is at the discretion of the most responsible care provider, as per local procedures.
15857103|NCT03985592|Behavioral|Education|Intervention description provided in elaboration on arms of the study.
15857104|NCT03985579|Other|Kinesiology taping application|Application of elastic cotton strip with an acrylic adhesive that is used with the intent of treating pain and disability from athletic injuries and a variety of other physical disorders
15857105|NCT03985566|Dietary Supplement|Fibre Grain|Healthy subjects will be provided with 30% Fibre Grain in a mixed meal. After consumption of the meal, the glucose and insulin response will be compared.
15857106|NCT03985566|Dietary Supplement|Jasmine white rice|Healthy subjects will be provided with Jasmine white rice in a mixed meal. After consumption of the meal, the glucose and insulin response will be compared.
15857107|NCT03985553|Behavioral|Parenting Self-Management Program|
15857108|NCT03985540|Behavioral|Behavorial; memory exercise|Memory training twice a week for 5 weeks.
15857109|NCT03985540|Behavioral|Placebo; memory exercise|Placebo Memory training twice a week for 5 weeks
15857110|NCT03985540|Behavioral|Behavioral: speed exercises|Speed training twice a week for 5 weeks.
15857111|NCT03985540|Behavioral|Placebo speed training|Placebo Speed training twice a week for 5 weeks.
15857112|NCT03985527|Device|Transvenous nerve stimulation|Acute transvenous nerve stimulation during a commercial implant of remedē® System
15857113|NCT03985514|Drug|Antibiotic treatment (Piperacillin/Tazobactam, 4 gram x 3), followed by 8-10 days of out-hospital oral antibiotic treatment (Ciprofloxacin 500 mgx2,Flagyl 400 mgx3).|Intravenous antibiotic treatment x 3, followed by oral antibiotics for 8-10 Days.
15857114|NCT03985514|Other|Active observation|In-hospital observation without antibiotics
15866277|NCT03911648|Drug|0.5 ml.kg-1 bupivacaine 0.25%|Caudally
15857119|NCT03985449|Other|Uterine Fibroid Option Grid encounter patient decision aid (text only)|The uterine fibroid Option Grid patient decision aid facilitates choice awareness and deliberation about treatment options when clinicians and patients discuss the management of uterine fibroids. The content is organized in a tabular format and is based on patients' frequently asked questions.
15857120|NCT03985449|Other|Uterine Fibroid Option Grid encounter patient decision aid (text + Pictures)|The Picture Option Grid uses the same evidence as the text version while integrating images and simpler text, thus utilizing pictorial superiority to help patients better understand and remember information more easily compared to just using words.
15857121|NCT03985449|Other|Uterine Fibroid Option Grid encounter patient decision aid (online)|Clinicians can click a link in the electronic health record that will lead them to the EBSCO Health website where they can click the treatment options relevant to the patient and generate a decision aid.
15857122|NCT03985436|Behavioral|Trek for Surgical Success|Cognitive behavioral therapy for pain
15857123|NCT03985423|Drug|Emapalumab-Lzsg|Emapalumab administered intravenously at the initial dose of 6 mg/kg, and continued at the dose of 3 mg/kg every 3 days until Study Day 15, and twice-a-week afterwards
15857124|NCT03985410|Drug|ETX2514|intravenous infusion
15857125|NCT03985410|Drug|Placebo|intravenous infusion
15857126|NCT03985410|Drug|moxifloxacin|oral tablet
15857127|NCT03985397|Other|discharge training|Providing planned discharge training according to the level of knowledge about diet, drug and individual monitoring compliance and cardiovascular risk factors of patients with acute myocardial infarction
15857128|NCT03985384|Drug|Semaglutide 2 MG/1.5 ML Subcutaneous Solution|Semaglutide 2 MG/1.5 ML Subcutaneous Solution
15857129|NCT03985384|Drug|Placebo|Placebo 1.5 ml, pen-injector for SC injection.
15857130|NCT03985371|Drug|EDTA Eye Drops|One drop in the Band Keratopathy affected eye only, two times per day for six months.
15857131|NCT03985358|Other|Opioid counseling plus standard of care instructions|Same counselor (investigator on the study) will use the same counseling script at the randomization visit as well as at the visit where they come in for pre-admission testing prior to surgery (as a refresher) to counsel patients
15857132|NCT03985345|Device|intravaginal device (probe) EMY|Free use of EMY and its mobile application for 10 minutes during 5 different days per week.
15857133|NCT03985319|Drug|YYD601 20mg|Esomeprazole IR 10mg + Esomeprazole SR 10mg (Expected efficacy and effects: GERD)
15857134|NCT03985319|Drug|Nexium tab 20mg|Esomeprazole magnesium trihydrate 22.3mg Effecacy and Effects: GERD and Antibiotics combined therapy to eradicate the Helicobacter pylori
15857135|NCT03985306|Procedure|Inforatio technique|"We define the inforatio technique as punch biopsies taken in the periphery of the wound bed. The punch biopsies will have a diameter of two mms. The depth of the biopsies is primarily based on clinical assessment on distance to bone by assessment with a sterile wound probe and with attention to location and anatomy. The maximum depth will be 3.5 millimeters. The biopsies will be taken from one to two mms from the wound edges and with a distance of five mms between the biopsies.
~Inforatio technique is applied after standard care and wound assessment."
15857136|NCT03985293|Drug|Placebo|4 matching placebo tablets taken twice a day (BID)
15857137|NCT03985293|Drug|PF-06882961|Participants will be randomized to one of 5 active doses (2.5, 10, 40, 80, or 120 mg), taking 4 tablets twice daily for 16 weeks.
15857138|NCT03985280|Device|Cooled radiofrequency|Under guidance of combined X-ray and ultrasound the nerves will be located . After local anesthetic aplication cooled RF needle will be apply in the objective position. Cooled RF will be performed for 2:30 minutes at 60 º C degrees.
15857139|NCT03985280|Drug|Intraaticular steroids and local anesthetic injections|Intraaticular steroids and local anesthetic injections
15857141|NCT03985254|Other|Strength Training Group (STG)|"The strength training program will consist of applying resistance and progressive exercises for strength gain and will be based on the training principles recommended by the American College of Sport Medicine. The exercises were chosen based on a pilot study that successfully applied the protocol to 10 participants with FPD (data to be published) and other strength training studies (MASCALL et al, 2003; DISTEFANO et al, 2009; REIMAN et al, 2012; BALDON et al, 2014; SILVA et al, 2015).
~Initially, the goal will be the development of neuromotor control and resistance (load <50% of the one repetition maximum test [1RM]), and in subsequent weeks the goal will be the development of muscle strength (load> 70% 1RM). In addition, the protocol will initially focus on strengthening the hip and trunk muscles and after four weeks of training, exercises for the knee muscles will be included."
15857142|NCT03985254|Other|Strength and Power Training Group (SPTG)|Participants who are allocated to this group will perform the same exercise program performed by the STG, but with the addition of exercises that emphasize power gain. As in the other group, initially, the objective will be the development of neuromotor control and resistance (load <50% of the one repetition maximum test [1RM]). However, in subsequent weeks the goal will be to develop strength (load> 70% 1RM) and muscle power (load between 40-60% 1RM).
15857143|NCT03985241|Diagnostic Test|Functional Assessment of Myocardial Ischemia by icECG|
15857144|NCT03985228|Dietary Supplement|Fortified milk|Ultra high temperature UHT, partly-skimmed milk (1% fat), highly digestible (lactose <0.01%), enriched in whey protein (5%) and calcium (0.24%), supplemented with unsaturated fatty acids omega-3 (DHA + EPA), vitamins (D, B12, B6, B9, E, C), prebiotics (FOS) and phyto curcuminoids (sunflower lecithin). Milk had to be associated with a packet of lyophilized and concentrated probiotics (Bifidobacteria infant-type and / or Lactobacilli), at the time of consumption. Milk and probiotics had been produced or supplied by Granarolo s.p.a.
15857145|NCT03985228|Dietary Supplement|Placebo milk|"Ultra high temperature UHT, partly-skimmed milk (1% fat), highly digestible (lactose <0.01%) with standard proteins of milk (3.1%) and color additive quantum satis. Milk had to be associated with a packet of maltodextrin Food Grade, at the time of consumption. Milk and maltodextrin had been produced or supplied by Granarolo s.p.a."
15857146|NCT03985215|Other|Questionnaires|Pediatric Quality of Life Inventory questionnaire. Self-designed questionnaire.
15857179|NCT03984903|Other|Multimedia Learning of Exercises|Patients learn exercise from multimedia content.
15867603|NCT03900949|Drug|Gemtuzumab Ozogamicin|Given IV
15857147|NCT03985202|Other|Structured exercise programme|9 week structured exercise programme. 3 sessions per week. (Intervention).The patient will be invited to the hospital for a 45-minute exercise counselling session, incorporating behaviour modification techniques. These behaviour modification techniques will be reinforced during the supervised exercise sessions. Participants will be offered 3 sessions of supervised aerobic interval exercise sessions per week on a cycle ergometer for 9 weeks.Exercise programmes will be tailored to each patient, taking previous level of activity, mobility and any barriers to exercise into consideration.
15857148|NCT03985189|Drug|ME-401|ME-401 will be administered at 2 dosages as 45 mg (Cohort 1) or 60 mg (Cohort 2), daily oral administration, QD, and the trial will be initiated at Cohort 1, and medical specialists and the Efficacy and Safety Assessment Committee as needed will decide whether the Cohort will be shifted to the next stage based on their assessment of the safety and tolerability.
15857149|NCT03985176|Device|ROTEM|ROTEM measurements 24,48, 72, 120, 192 and 288 hours from aneurysmal SAH
15857150|NCT03985176|Procedure|EEG|Continuous EEG-monitoring after aneurysm treatment until patient transferred to ward or up to 14 days after aneurysmal SAH
15857151|NCT03985176|Procedure|bilateral compression ultrasound of the lower extremity veins|to exclude asymptomatic deep venous thrombosis once over days 3 to 7
15857152|NCT03985163|Other|Patient Reported Outcomes Electronic Survey|This study does not include a drug, test, behavioral or medical procedure intervention; participants will be asked to complete three surveys
15857153|NCT03985150|Other|Biomechanical analysis of femoralis superficialis atherosclerotic tissue|Tissue collection during above-knee amputation; mechanical testing of tissue; microstructural testing of tissue
15857154|NCT03985150|Radiation|CT or MR angiogram|Obtaining in vivo geometry of diseased artery
15857155|NCT03985137|Other|mucocutaneous sampling by swab at the balano-preputial furrow.|the sample is made by the patient
15857156|NCT03985124|Behavioral|Tuning in to Kids for Teachers|This is an emotion-focused intervention for teachers giving them skills in emotion coaching children in their care and also understanding and managing their own emotions.
15857157|NCT03985111|Device|Central Venous Catheter|Insertion of a central venous catheter insertion pre-operatively (electively)
15857158|NCT03985098|Behavioral|Motivational interviewing intervention arm|The intervention will be a phone call by a pharmacy student that will use MI strategies to identify and address the adherence barrier(s) and 5 monthly follow up calls
15857160|NCT03985072|Drug|Andes-1537 for Injection|Andes-1537 administered subcutaneously five days per week.
15857161|NCT03985059|Other|Transcranial Doppler|"Initially, the patient will be placed in a strict supine position (at 0°) in his hospital bed in the USINV, according to the usual care. In a second step, the patient will be verticalized (from 0° to 90°). HI parameters in supine position and during verticalization will be recorded continuously by placing the transcranial Doppler helmet.
~After 15 minutes of recording, the patient will be placed back in supine position. The end of the patient's participation in the study will correspond to the removal of the helmet."
15857162|NCT03985046|Drug|Sintilimab plus Chemotherapy|Sintilimab will be administered intravenously, a fixed dose of 200 mg. Paclitaxel 135mg/m2, carboplatin AUC=6. Once every 3 weeks.
15857163|NCT03985033|Other|leucocyte and platelet-rich fibrin (L-PRF)|The blood collected from each patient will be centrifuged immediately at 2700 rpm for 12 min to separate L-PRF.
15857164|NCT03985020|Other|Stevia Intervention|We will use commercially available stevia sweetened soft drink Zevia.
15857165|NCT03985020|Other|Water Intervention|Bottled Water
15857166|NCT03985007|Drug|CDIAG regimen|Chidamide 30mg orally twice every week for 2 weeks on days 1, 4, 8, 11, decitabine 20mg/m2 intravenously daily for 5 days (d1-d5) and IAG regimen (cytarabine, 10 mg/m2 subcutaneously every 12 h on days 4-17; idarubicin, 5mg intravenously every other day on days 4, 6, 8, 10, 12, 14; and concurrent granulocyte colony-stimulating factor, 200mg/m2/day subcutaneously daily on days 3-17.
15857167|NCT03984994|Other|Aerobic exercise training|3 months of center-based, supervised treadmill exercise
15857168|NCT03984994|Other|Strength training|3 months of center-based, supervise strength training
15857169|NCT03984981|Other|Assessment of process required to diagnose brain death in adult patients|Assessment of process required to diagnose brain death in adult patients (demographics, clinical, laboratory, imaging, and treatment data). No questionnaires or study visits will be used.
15857170|NCT03984968|Biological|CAR-T infusion|Patients enrolled in this arm will receive CAR-T infusion
15857171|NCT03984955|Device|Sodium hyaluronate with mannitol (Ostenil Tendon)|1ml isotonic solution contains 20.0mg sodium hyaluronate and sodium chloride, disodium phosphate, sodium dihydrogen phosphate, mannitol and water for injections.
15857172|NCT03984955|Device|Platelet-Rich Plasma Injection|Platelet-rich plasma (PRP) describes an autologous blood plasma fraction enriched with platelets which is then injected at the site of tendon injury.
15857173|NCT03984955|Other|Subcutaneous sham injection|Sham injection will penetrate the skin, but no therapeutic substance will be injected
15857174|NCT03984929|Behavioral|Conexion Localized|The localized version of Conexion is an online health information resource on diabetes and depression tailored for the target community.
15857175|NCT03984929|Behavioral|Conexion Generic|The generic version of Conexion is an online health information resource on diabetes and depression.
15857176|NCT03984916|Dietary Supplement|Hesperidin Pharma|Two capsules with 250 mg of sweet orange extract with a mixture of hesperidin isomers -S and -R.
15857177|NCT03984916|Dietary Supplement|Hesperidin Pharma_M|Two capsules with 250 mg of sweet orange extract each with a mixture of hesperidin isomers -S and -R and micronized.
15857178|NCT03984916|Dietary Supplement|Cardiose|Two capsules with 250 mg of sweet orange extract each with more than 90% of hesperidin as isomer -S and micronized.
15857180|NCT03984903|Other|Face-to-face Learning of Exercises|Physiotherapist teach exercises to patients
15857181|NCT03984903|Other|Manual Therapy|Myofascial Release Techniques and Joint Mobilizations to the Lumbal Area
15857182|NCT03984903|Other|Home Exercise Program|Patients do at least 20 minutes motor control exercise in a day at home.
15857183|NCT03984890|Drug|Vitamin D3|Vitamin D3 drops 800IU/d for 3 months
15857184|NCT03984890|Drug|Traditional treatment of CGD and TB|Anti-tuberculosis drugs, interferon-gamma
15857185|NCT03984877|Diagnostic Test|Diagnosis of amyloidosis|Scintigraphy and protein electrophoresis
15857186|NCT03984864|Other|Exercise therapy|3-4 items from a list of 10 general exercises - intended for treatment of low back pain
15857187|NCT03984838|Drug|JULUCA (Dolutegravir and Rilpivirine) 50mg/25mg FDC tablet|JULUCA tablets will be administered orally once daily with a meal. It will be available as a fixed dose combination of Dolutegravir 50mg and Rilpivirine 25mg.
15857188|NCT03984825|Drug|GSK3640254|GSK3640254 will be available as a 100 mg capsule. Subjects will be administered 200 mg GSK3640254 once daily via the oral route on Days 11 to 21.
15857189|NCT03984825|Drug|Portia|Portia will be available in the form of tablets containing 0.03 mg ethinyl estradiol and 0.15 mg levonorgestrel.
15857192|NCT03984799|Procedure|Bronchoscopy|Samples obtained during bronchoscopy and blood samples will be evaluated to define inflammatory markers of COPD
15857193|NCT03984786|Behavioral|Assessment Interview|An interviewer will administer a pre-treatment assessment interview. This 30-45 minute interview will be performed after randomization immediately after the initial telephone screen, where the interviewer will use the AUD section of the SCID-5.
15857194|NCT03984786|Behavioral|Guidance|Guidance from a health educator through regular weekly online messages. Participants may also be contacted through emails and phone calls. The team of guides consists of registered social workers, psychologists, and graduate students, with experience delivering ICBT.
15857195|NCT03984786|Behavioral|ICBT for alcohol misuse|The 8-week internet-delivered cognitive behaviour therapy (ICBT) course for alcohol misuse. The course consists of 12 lessons distributed across 8 weeks (1 to 2 lessons a week).
15857196|NCT03984773|Behavioral|Nudge|Oncology practices will be randomly assigned to receive an intervention, in which individual clinicians will receive a weekly audit email detailing how many serious illness conversations (SIC) they have had compared to the recommended level, and a link to a list of their patients scheduled in clinic next week at high risk of short-term mortality as identified by a mortality prediction algorithm. Clinicians will have the chance to review the opt-out list and pre-commit to a serious illness conversation with appropriate patients. Clinicians will receive nudge on the day of the patient visit via text message reminding them of their pre-commitment to conduct a serious illness conversation.
15857197|NCT03984760|Drug|Ferric Citrate|Take the capsules with meals or immediately after meals.
15857198|NCT03984760|Drug|Sevelamer Carbonate|Take the tablets with meals.
15857199|NCT03984734|Procedure|Pancreatoduodenectomy with antrectomy|
15857200|NCT03984734|Procedure|Pylorus-preserving pancreatoduodenectomy|
15857201|NCT03984721|Diagnostic Test|Amyloidosis typing using mass spectrometry-based proteomics|Amyloidosis typing using nanoLC-MS/MS method
15857202|NCT03984708|Other|Samples|Blood sample, skin biopsy
15857203|NCT03984708|Other|Indirect calorimetry|Measurement of energy expenditure by indirect calorimetry
15857204|NCT03984708|Other|Electrical bioimpedance|Measurement of electrical bioimpedance
15857205|NCT03984695|Behavioral|SHE-WOMEN|SHE-WOMEN is a text-Web intervention designed to increase jail-involved women's health literacy, reduce risk, and increase screening for prevention of cervical cancer, breast cancer, unintended pregnancy, and sexually transmitted infections.
15857206|NCT03984682|Procedure|Joint Crisis Plan|A Joint Crisis Plan will be drafted with the patient and a nurse
15857207|NCT03984669|Diagnostic Test|The Juvenile Disease Activity Score (JADAS)|The JADAS includes the following four measures: physician's global assessment of disease activity, measured on a 0-10 visual analog scale (VAS) where 0 = no activity and 10 = maximum activity; parent global assessment of well-being, measured on a 0-10 VAS where 0 = very well and 10 = very poor; the erythrocyte sedimentation rate (ESR), normalized to a 0 to 10 scale; and a count of joints with active disease.
15857208|NCT03984669|Biological|(1-3)-ß-D-Glucan (BDG) assay (Fungitell)|Evaluation of the (1,3)-Beta-D-Glucans level in patients with JIA and correlation of the higher serum BDG levels with JIA activity of disease, comparatively with usual markers
15857209|NCT03984656|Drug|lidocaine treatment|The index marks the upper edge of the lower rib of the selected intercostal space to avoid the vasculonervous bundle sitting at the lower part of the overlying rib.Non-targeted subcutaneous infiltration is performed in the drainage area with 5 to 10 mL of Lidocaine 20 mg / mL non-adrenaline, plane by plane, with regular aspiration until air or fluid confirming effusion.
15857210|NCT03984656|Drug|serratus plane block treatment|"The Serratus plane block is located at the level of the 5th rib, on the midaxillary line, on the drainage side, ultrasound guided. The block is performed with a 70 mm needle in the ultrasound plane, and the needle is directed postero-inferior, after visualization of the structures from the surface to the depth: dorsal muscle
~anterior serratus large muscle (serratus anterior)
~intercostal muscle
~4th and 5th ribs
~pleura A single injection of 30 mL of Ropivacaine 4.75 mg / mL is performed around the Serratus muscle.
~An intravenous injection of 8 mg of Dexamethasone is added to prolong the duration of the block."
15857211|NCT03984643|Device|Vim-Deep Brain Stimulation|This study consists of testing additional model-derived DBS settings during initial and regular follow-up clinical visits every 6 months for up to 2 years in which individuals with DBS implants are re-evaluated by a clinician to make sure that the stimulation settings employed during the previous clinical visit remain therapeutic. It is important to note that this study is post-surgical and all procedures (i.e. stimulation settings that will be tested in the clinic) are within the FDA-approved range of stimulation settings available on the implanted pulse generator.
15857244|NCT03984422|Other|Smartphone application|use of smartphone application during 2 weeks to 3 months to collect frequency and duration of crises, RCS, photography of finger.
15857212|NCT03984630|Behavioral|Dietary Fiber Intervention|Intervention included weekly group-based phone counseling with a Registered Dietitian (RD) to encourage consumption of a high fiber diet (≥30 g/day). All women reported their body weight weekly.
15857213|NCT03984617|Other|Emergency visit in a French tertiary Maternity hospital (Maternity of Nancy)|total number of visits (hospitalizations and consultations)
15857214|NCT03984604|Drug|CHI-921|a standardized cannabis extract in sunflower oil administered in oral liquid (oil) form
15857215|NCT03984604|Drug|Placebo|Placebo is a vehicle oil will match CHI-921
15857216|NCT03984591|Drug|Eplerenone|Eplerenone according to guidelines
15857217|NCT03984591|Drug|Spironolactone|Spironolactone according to guidelines
15857218|NCT03984578|Drug|CAPEOX|Oral Capecitabine: 1000mg/m2 twice a day from Day 1 to 14 of a 3-week cycle, and IV Oxaliplatin: 130mg/m2 on Day 1
15857219|NCT03984578|Drug|Pembrolizumab|IV infusion of 200mg on Day 1 and Day 22
15857220|NCT03984578|Drug|Capecitabine/ 5-FU|Capecitabine: Oral dose of 825mg/m2/day twice a day on radiation days with concurrent radiation median 50.4 Gy/ 28 fractions; or 5-FU: 225mg/m2/day concurrent with radiation
15857221|NCT03984578|Drug|Pembrolizumab|IV infusion of 200mg on Day 1 of each cycle
15857222|NCT03984578|Procedure|Surgical resection|Performed after all medical intervention
15857223|NCT03984565|Drug|Cannabidiol|Cannabidiol sublingual product formulated in coconut oil
15857224|NCT03984565|Drug|Placebo|Placebo sublingual product formulated in coconut oil
15857225|NCT03984552|Behavioral|This was an observational study of medical devices (rapid tests) used for the HIV diagnosis in children up to 2 years|"These rapid tests are based on lateral flow immunochromatography technology, in which a nitrocellulose membrane is impregnated with the antigen of interest. The patient sample (blood, serum, plasma, oral fluid, etc.) is applied in this membrane which facilitates the interaction of antibodies in the sample with the antigens on the membrane. This reaction becomes visible to the naked eye thanks to a color developing revelator.
~The entire testing process, from sample collection to result reading takes no more than 40 minutes and does not depend on laboratory facilities."
15857226|NCT03984539|Behavioral|Cognitive Behavioural Therapy-Enhanced|CBT-E is a 20-session transdiagnostic eating disorders treatment based on the principles of cognitive behavioural therapy which has been developed over the past 40 years. The treatment focusses on tracking and modifying eating behaviours, providing psychoeducation, addressing overvaluation of weight and shape, body image, food restriction and restraint, emotion regulation, and relapse prevention.
15857227|NCT03984539|Behavioral|Cognitive Behavioural Therapy-Ten|CBT-T is a 10-session treatment based on cognitive behavioural therapy. It was developed based on clinical experience as well as core components of evidence-based versions of CBT for eating disorders, including CBT-E. The aim of the intervention is to provide only the hypothesized critical elements of CBT for eating disorders so that the interventions can be provided quicker.
15857228|NCT03984526|Drug|normal saline|intravenous normal saline pretreatment at the onset of dexmedetomidine infusion
15857229|NCT03984526|Drug|atropine 0.5mg|intravenous atropine 0.5mg pretreatment at the onset of dexmedetomidine infusion
15857230|NCT03984526|Drug|ephedrine 8mg|intravenous ephedrine 8mg pretreatment at the onset of dexmedetomidine infusion
15857231|NCT03984513|Behavioral|Surviving and Thriving in the Real World|The Surviving and Thriving in the Real World intervention consists of 14 weekly concurrent adolescent and parent group sessions. The daily living skills to be targeted in the intervention include: Morning Routine (i.e., completing a morning personal hygiene routine); Laundry (i.e., sorting clothing, using a washing machine and dryer, and folding and putting clothes away); Kitchen/Cooking (i.e., cooking items in the microwave, oven, and stove, safe kitchen practices, cleaning up the kitchen after cooking, and grocery shopping); Self-Management (i.e., managing worry and stress related to learning daily living skills and transitioning to adulthood); and Money Management (i.e., using money to purchase items, evaluating the quality and price of items, understanding and using a checking and savings account, and budgeting money to cover expenses).
15857232|NCT03984513|Behavioral|Program for the Education and Enrichment of Relational Skills|Program for the Education and Enrichment of Relational Skills is an evidence-based social skills training program for youth with social challenges between the ages of 13-18.The program includes a teen group and a parent group that meet concurrently. Teens learn about conversations, electronic communication, joining groups, humor, handling teasing and disagreements, and planning a get-together with other teens. Parents learn how to coach their teens to continue to use the skills when the program is complete.
15857233|NCT03984500|Other|Education|SCTaware education (Phase II) will be compared to Ohio's current in-person SCT education (Phase I).
15857234|NCT03984487|Behavioral|Surviving and Thriving in the Real World|The STRW intervention consists of 14 weekly concurrent adolescent and parent group sessions. The DLS to be targeted in the intervention include: Morning Routine (i.e., completing a morning personal hygiene routine); Laundry (i.e., sorting clothing, using a washing machine and dryer, and folding and putting clothes away); Kitchen/Cooking (i.e., cooking items in the microwave, oven, and stove, safe kitchen practices, cleaning up the kitchen after cooking, and grocery shopping); Self-Management (i.e., managing worry and stress related to learning DLS and transitioning to adulthood); and Money Management (i.e., using money to purchase items, evaluating the quality and price of items, understanding and using a checking and savings account, and budgeting money to cover expenses).
15857235|NCT03984487|Behavioral|Program for the Education and Enrichment of Relational Skills|PEERS is an evidence-based social skills training program for youth with social challenges between the ages of 13-18.The program includes a teen group and a parent group that meet concurrently. Teens learn about conversations, electronic communication, joining groups, humor, handling teasing and disagreements, and planning get-togethers with other teens. Parents learn how to coach their teens to continue to use the skills when the program is complete.
15857236|NCT03984461|Biological|Autologous cell therapy|Biologic material is harvested from the participant and re-injected into an osteoarthritic joint
15857347|NCT03983668|Drug|CMP-001|Immunostimulatory therapeutic agent
15857245|NCT03984409|Dietary Supplement|Kroger low calorie orange juice beverage|Kroger low calorie orange juice beverage will be consumed for 7 days followed by a 24 hour urine collection with Litholink to see if urine alkalization similar to potassium citrate can be achieved
15857246|NCT03984396|Other|Educational Materials - Patient & Clinician|deprescribing information for patient & clinician
15857247|NCT03984370|Drug|ZP4207|Abdominal SC administration
15857248|NCT03984370|Other|Placebo (saline)|Abdominal SC administration
15857249|NCT03984357|Drug|PD-1 blocking antibody|"Whole-course concurrent PD-1 blocking antibody: every 3 weeks × 6 cycles; 360 mg, day 1; start on day 1 of the first cycle IC and continue every 3 weeks for 6 cycles till the end of IMRT, involving the whole-course of IC + IMRT alone.
~Adjuvant PD-1 blocking antibody: every 4 weeks × 6 cycles; 480 mg, day 1"
15857250|NCT03984357|Drug|Gemcitabine|Gemcitabine as induction chemotherapy, 1000 mg/m2 day 1, 8 per cycle, every 3 weeks for 3 cycles
15857251|NCT03984357|Drug|Cisplatin|Cisplatin as induction chemotherapy, 80 mg/m2 day 1 per cycle, every 3 weeks for 3 cycles
15857252|NCT03984357|Radiation|Intensity-modulated radiotherapy|Definitive IMRT of 70 Gy, 33 fractions, 5 fractions/week, 1 fraction/day
15857253|NCT03984344|Device|Intermittent Theta Burst Stimulation|The Magstim Rapid2 Magnetic Stimulator (Magstim ®, UK) will be used to administer active TBS.
15857254|NCT03984344|Device|Continuous Theta Burst Stimulation|The Magstim Rapid2 Magnetic Stimulator (Magstim ®, UK) will be used to administer active TBS.
15857255|NCT03984344|Device|Sham Theta Burst Stimulation|The Magstim Rapid2 Magnetic Stimulator (Magstim ®, UK) will be used to administer TBS using a sham Magstim coil.
15857256|NCT03984331|Device|Fish skin|One out of two adjacent burn sites of 10-20 cm x 7cm surface area will be randomized to receive fish skin as early cover. Each patient thus serves as his/her own control. After 7 +/- 3 days the burn site will receive a meshed split thickness skin graft.
15857257|NCT03984331|Device|Cadaver skin|One out of two adjacent burn sites of 10-20 cm x 7cm surface area will be randomized to receive cadaver skin as early cover. Each patient thus serves as his/her own control. After 7 +/- 3 days the burn site will receive a meshed split thickness skin graft.
15857258|NCT03984318|Procedure|Blood sample|Blood (plasma+serum+PBMC) collection before the start of immunotherapy, at week 6 and upon grade ≥2 irAE.
15857259|NCT03984305|Device|Personal KinetiGraph® (PKG®) Watch|"The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:
~A wrist-worn data logger (PKG Watch) designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period.
~An application to configure the data logger and transfer the acquired data at the end of a recording."
15857260|NCT03984305|Device|Personal KinetiGraph® (PKG®) Report|"The Personal KinetiGraph (PKG®) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by GKC.
~The Personal KinetiGraph (PKG®) Movement Recording System consists of the following:
~• A series of algorithms that analyze the uploaded data, producing a PDF that is delivered to the clinician. The PDF contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility."
15857261|NCT03984292|Procedure|Teaching of laparoscopic skills on a box simulator|The students shall be trained a laparoscopic simulator for a variable duration and the outcome shall be compared.
15857262|NCT03984279|Other|Patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control|Not applicable, all patients with indication of interventional percutaneous diagnostic or therapeutic chest-abdomen-pelvic procedure under CT control on a period of 1 year will be taken into account
15857263|NCT03984266|Diagnostic Test|NGS panel|A next-generation-sequencing panel, which contains a group of genes that specifically cause disease, for mutational analysis in newborns.
15857264|NCT03984240|Drug|Midazolam|Participant will be sedated by midazolam.
15857265|NCT03984240|Drug|Dexmedetomidine|Participant will be sedated by dexmedetomidine.
15857266|NCT03984227|Genetic|Taking peripheral blood samples|quantitative real-time polymerase chain reaction
15857267|NCT03984214|Drug|Dronabinol in Oral Dosage Form|Titration period for 4 weeks: titration according to tolerability from 2.5 mg (3 x 1 droplet) up to 30 mg (3 x 12 droplets) per day; dose increased by 2.5 mg (3 x 1 droplet) every other day Maintenance period for 12 weeks: individually tolerated maximum dose (up to 30 mg ≙ 3 x 12 droplets) at end of titration period will be continued for maintenance treatment Tapering period for 2 weeks: dose is decreased every other day by 5 mg (3 x 2 droplets) Safety follow-up: 4 weeks after end of treatment
15857268|NCT03984214|Drug|Placebo in Oral Dosage Form|Titration period for 4 weeks: titration according to tolerability from 3 x 1 droplet up to 3 x 12 droplets per day; dose increased by 3 x 1 droplet every other day Maintenance period for 12 weeks: individually tolerated maximum dose (up to 3 x 12 droplets) at end of titration period will be continued for maintenance treatment Tapering period for 2 weeks: dose is decreased every other day by 3 x 2 droplets Safety follow-up: 4 weeks after end of treatment
15857269|NCT03984201|Device|Intermittent Theta Burst Stimulation (iTBS)|Participants will receive active or sham transcranial magnetic stimulation delivered to the L-DLPFC.
15857270|NCT03984188|Drug|Theophylline ER|200 mg extended release (ER) low-dose theophylline taken orally daily
15857271|NCT03984188|Drug|Placebo oral tablet|Manufactured methylcellulose placebo tablet taken orally daily
15857272|NCT03984188|Other|Standard of Care Treatment|Per World Health Organization (WHO) guidelines for management of Chronic Obstructive Pulmonary Disease (COPD) treatment
15857273|NCT03984175|Procedure|Implementation of Processes|Implementation of processes to improve compliance with low tidal volume ventilation in patients with ARDS using a computerized protocol
15857274|NCT03984149|Other|Observational study|Observational study: There is no intervention.
15857275|NCT03984136|Behavioral|COHIV with exchange mechanism|A WeChat-based mini program has been developed to send and receive Center for Disease Control and Prevention certified online HIV results (COHIV). WeChat is the ubiquitous communication and social networking tool in China. Participants in the intervention group will receive his friend's COHIV only when the participants share their own in exchange. If the participant already has the COHIV, the system will lead the user to send his COHIV to the friend. If the participant does not have the COHIV, the system will guide him to make online appointment at the testing clinic.
15857348|NCT03983668|Drug|Pembrolizumab|Humanized antibody used in cancer immunotherapy
15857276|NCT03984136|Behavioral|COHIV without exchange mechanism|The participants in the control group will be able to receive the friend's Center for Disease Control and Prevention certified online HIV results (COHIV) entirely at the friend's discretion without the mandatory exchange requirement. The system will also guide users on how to get an HIV test by making appointments with the MSM friendly clinics in the mini program.
15857277|NCT03984123|Device|Brachial cuff, in order to achieve ischemic stimuli|Standard treatment with no brachial cuff inflation
15857278|NCT03984110|Drug|Ozurdex|Intravitreal injection
15857279|NCT03984110|Drug|Eylea|Intravitreal injection
15857280|NCT03984097|Drug|TAK-079|TAK-079 subcutaneously.
15857281|NCT03984097|Drug|Lenalidomide|Lenalidomide orally.
15857282|NCT03984097|Drug|Dexamethasone|Dexamethasone orally.
15857283|NCT03984097|Drug|Bortezomib|Bortezomib subcutaneously.
15857284|NCT03984097|Drug|Pomalidomide|Pomalidomide orally.
15857285|NCT03984084|Other|no intervention|no intervention
15857287|NCT03984045|Drug|Lidocaine topical|Intranasal 2% lidocaine delivered directly to SPG
15857288|NCT03984045|Drug|Prochlorperazine Injection|intravenous prochlorperazine at 0.15mg/kg max 10 mg
15857289|NCT03984032|Device|LMA Protector Cuff Pilot|Assessing the clinical performance of LMA Protector Cuff Pilot
15857290|NCT03984032|Device|LMA Supreme|Assessing the clinical performance of LMA Supreme
15857291|NCT03984019|Diagnostic Test|Cardiac condition measurements|Cardiac MRI, ECG, echocardiography, cardiac blood markers
15857292|NCT03983993|Drug|Niraparib|Given PO
15857293|NCT03983993|Biological|Panitumumab|Given IV
15857294|NCT03983980|Drug|Tapinarof (DMVT-505)|Tapinarof cream, 1%, applied once daily
15857295|NCT03983980|Drug|Vehicle Cream|Vehicle cream applied once daily
15857296|NCT03983967|Biological|Immuncell-LC|Activated T lymphocyte
15857297|NCT03983954|Combination Product|Obinutuzumab pretreatment (Gazyva®) Naptumomab estafenatox (ABR-217620; NAP) and durvalumab (IMFINZI; MEDI4736)|"Obinutuzumab is given intravenous (I.V.) 1,000 mg concentrate for solution for infusion.
~NAP is given as an intravenous (I.V.) bolus injection at multiple doses. Durvalumab is given at a dose of 1120 mg, I.V, 1- 1.5 hours after completion of the administration of NAP on the second day of each 21-day cycle, and when administered as monotherapy at a dose of 1500 mg delivered once every 28 days."
15857298|NCT03983954|Combination Product|Naptumomab estafenatox (ABR-217620; NAP) and durvalumab (IMFINZI; MEDI4736)|NAP is given as an intravenous (I.V.) bolus injection at multiple doses. Durvalumab is given at a dose of 1120 mg, I.V, 1- 1.5 hours after completion of the administration of NAP on the second day of each 21-day cycle, and when administered as monotherapy at a dose of 1500 mg delivered once every 28 days.
15857299|NCT03983941|Drug|Ropivacaine injection|Total dose not to exceed 3 mg/kg of ropivacaine.
15857300|NCT03983928|Drug|TQB2450|TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
15857301|NCT03983928|Drug|Anlotinib|a multi-target receptor tyrosine kinase inhibitor
15857302|NCT03983915|Drug|Dexmedetomidine|Dexmedetomidine was used as a sedation agent with less side effect on respiratory system.
15857303|NCT03983915|Drug|Remifentanil|Remifentanil was used to prevent cough induced by bronchoscopy.
15857304|NCT03983915|Device|Laryngeal mask|Laryngeal mask was used to ensure respiration function during general anesthesia.
15857305|NCT03983902|Procedure|Delayed cord clamping|Delayed cord clamping will occur for up to 2 minutes.
15857306|NCT03983902|Procedure|Umbilical cord milking|Umbilical cord milking will occur milking of the 30 cm of the cord from placental site to baby, at a speed of 5 cm/second, 3 times in preterm newborns, 4 times in term newborns.
15857307|NCT03983902|Procedure|Immediate cord clamping|Immediate cord clamping will occur in 20 seconds after birth.
15857308|NCT03983889|Drug|Midazolam|Midazolam is used as a common medication for sedation in all groups.
15857309|NCT03983889|Drug|Fentanyl|Fentanyl is another opioid drug used for analgesia to prevent bronchoscopy induced cough.
15857310|NCT03983889|Drug|Dexmedetomidine|Dexmedetomidine is used for sedation in bronchoscopy with less impact on respiration.
15857311|NCT03983889|Drug|Remifentanil|Remifentanil is used for analgesia to prevent bronchoscopy induced cough.
15857312|NCT03983889|Drug|Propofol|Propofol is used for sedation with high efficacy but more side effect on respiration than dexmedetomidine.
15857313|NCT03983876|Drug|Adalimumab|"AVT02, a proposed similar biological product (biosimilar) of Humira which contains adalimumab . Adalimumab is a recombinant, fully human monoclonal immunoglobulin G1 (IgG1) antibody that binds specifically and with high affinity to the soluble and transmembrane forms of tumor necrosis factor (TNF)-α thereby inhibiting the binding of TNF-α with its receptor, and inhibiting TNF -α's biological function.
~Tumor necrosis factor-α is a naturally occurring cytokine that is key to normal inflammatory and immune responses. Elevated levels of TNF-α are found in the synovial fluid of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis patients and psoriasis plaques and play an important role in both the pathologic inflammation and joint destruction that are hallmarks of these inflammatory disease"
15857349|NCT03983655|Device|High Frequency Low Intensity TMS|125 hz, 10 gauss, 2 times daily for 6 monts
15857319|NCT03983837|Other|Neocate Splash|Neocate Splash is a hypoallergenic, amino acid based elemental liquid diet that is taken orally.
15857320|NCT03983824|Drug|Cytarabine|Given IV
15857321|NCT03983824|Drug|Etoposide Phosphate|Given IV
15857322|NCT03983824|Drug|Mitoxantrone Hydrochloride|Given IV
15857323|NCT03983824|Drug|Peposertib|Given PO
15857324|NCT03983811|Drug|Icotinib|Patients receive 4 cycles of platinum-based doublet chemotherapy on day 1 with intercalated icotinib (D8-15) every 3 weeks, and continued icotinib for 2 years or until the occurrence of disease relapse, metastasis or unacceptable icotinib or chemotherapy toxicity
15857325|NCT03983811|Drug|Placebo|Patients receive 4 cycles of platinum-based doublet chemotherapy on day 1 with intercalated placebo (D8-15) every 3 weeks, and continued placebo for 2 years or until the occurrence of disease relapse, metastasis or unacceptable toxicity
15857326|NCT03983811|Other|chemotherapy|Patients in each groups need to receive 4 cycles of platinum-based doublet chemotherapy
15857327|NCT03983798|Other|Simulation training in psychiatry|"Each participant will complete 6 hours of psychiatric simulation training, dealing with mood disorders, anxious disorders, eating disorders, borderline disorders, substance abuse and schizophrenia. Simulation training will be supplemented by brief lecture on concept map and portfolio at the beginning of the first hour.
~Curriculum integration of simulation training in psychiatric course assure that each pathology studied is supplemented by a one-hour lecture and 1 to 3 hours clinical cases and MCQ training. A part of the medical students are supplemented by clinical practice ; whereas the other won't benefit from clinical practice."
15857328|NCT03983785|Other|Pilates|In pilates group: Pilates training twice a week for 6 weeks.
15857329|NCT03983785|Other|Elastic taping|Elastic taping group: Elastic taping application after the pilates training twice a week for 6 weeks Wait List
15857330|NCT03983772|Dietary Supplement|RS blend|The intervention is a proprietary resistant starch blend.
15857331|NCT03983772|Other|Placebo|The placebo is starch.
15857332|NCT03983759|Drug|sintilimab maintenance|the patients with CR, PR or SD after the chemotherapy plus R-CIK will receive sintilimab maintenance therapy. The dose of sintilimab is fixed at 200mg every three weeks.
15857333|NCT03983746|Device|core stability exercises and treadmill training exercises|Forty-five children with Down syndrome included in the study. The children aged 4-6 years, and they were equally divided randomly into three groups (A), (B) and (C). Group A received traditional physical therapy intervention strategies to facilitate the balance of participated children. Group (B) received same as the group (A), with additional core stability exercises training. Group (C) received same intervention strategies as group (A) in conjunction with a treadmill exercise program. The children's balance was evaluated using the Berg Balance Scale and the Biodex Balance System. Treatment sessions were for 60 min, thrice a week, for eight consecutive weeks.
15857334|NCT03983733|Other|Dietary Intervention|To carry out an interventional dietary study using standardised meals to predict an individual's metabolic response to certain foods, using their gut microbiome, metabolic profile, and other measurable characteristics such as weight, sleep and exercise.
15857335|NCT03983720|Other|Evaluation of degree chronic fatigue.|Evaluation of degree chronic fatigue with the results of survey Fatigue Severity Scale (FSS) and Modified Fatigue Impact Scale (MFIS). This result will allow to divide patients in groups : lowly fatigued and highly fatigued.
15857336|NCT03983720|Other|Questionnaires|"Fatigue Severity Scale (FSS)
~Modified Fatigue Impact Scale (MFIS)
~Godin Leisure-Time Exercise Questionnaire (GLTEQ)
~Scale of life quality of multiple sclerosis (SEP-59)
~Center for Epidemiologic Studies Depression (CES-D)
~Pittsburgh Sleep Quality Index (PSQ-I)"
15857337|NCT03983720|Biological|Blood sample|Blood sample will be realized to evaluate anemia and inflammations.
15857338|NCT03983720|Other|Cardiopulmonary evaluation|Cardiopulmonary evaluation will be realized with a cycle ergometer.
15857339|NCT03983720|Device|Capacity of muscular oxygen extraction|Measure the capacity of muscular oxygen extraction with a cycle ergometer.
15857340|NCT03983720|Device|Sleep assessment|Sleep assessment will be measured by actigraphy during 15 days.
15857341|NCT03983720|Device|Metabolic fatigue|Metabolic fatigue will be measured by Magnetic Resonance Imaging (MRI).
15857342|NCT03983720|Other|Neuromuscular evaluation|"Neuromuscular evaluation will be measured by the composite of the results of:
~Fatigue test
~Measure of voluntary isometric force
~Surface electromyography
~Peripheral nerve stimulation
~Transcranial Magnetic Stimulation (TMS)
~Perceived fatigue
~Cognitive fatigue
~Thermoregulation"
15857343|NCT03983707|Device|Purastat®|Use of Purastat®
15857344|NCT03983694|Other|Erythrocyte transfusion|The cerebro-vascular effects of a clinically prescribed erytrocyte (red blood cell) transfusion is examined. Before the transfusion, BabyLux sensor is placed on the neonatal fronto-parietal region and held in place by a self-adhesive bandage. A baseline prior to transfusion is established through a series of five repeated measurements of 1 minute taken during a stable period just before the transfusion is started. Once transfusion has ended, another series of five repeated measurements of 1 minute taken during a stable period are performed to determine the responses. Cerebral oxygenation as determined by a commercial spatially resolved NIRS device with neonatal sensor will be continuously recorded during transfusion.
15857345|NCT03983681|Behavioral|Strategy-Based Training to Enhance Memory (STEM)|Protocol designed to improve memory functioning in individuals with neurological injuries administered for 4 weeks (8 training sessions).
15857346|NCT03983681|Behavioral|Placebo control exercises|Placebo control memory exercises will be administered for 4 weeks (8 training sessions).
15857350|NCT03983642|Device|Wii balance board|"Numerous video games exist to interact with the Wii Balance Board. One game that has been used in prior balance studies is Wii Fit.
~On the first 4 weeks, balance training started with Soccer Heading game. The participants were asked to control their avatar by leaning to left or to the right in order to avoid the objects that were thrown towards them, and try to score the balls inside the net. The participants performed 3 sets of 5 rounds (2min each), totaling 30 min, and rested for 1 min between each set.
~Table Tilt game continued for the remaining 4 weeks. Participants tried to enter balls into the holes by shifting their body weight on the balance board causing it to tilt in all directions. This game was divided into multiple levels of 30 seconds each, repeated over 30 min, with a one-minute rest interval between every 10 minutes of training. Moreover, 20 extra seconds were added each time a participant has won a level."
15857351|NCT03983629|Other|Collection of data and genetic analysis|Data collected are: History of disease, medical history, family medical history, biological results, Imaging results, disease progression Genetic analysis will be performed with whole genome and whole exome sequencing
15857352|NCT03983603|Dietary Supplement|Soft chews containing 0.5g plant stanols (delivered as plant stanol esters)|Soft chews containing 0.5g plant stanols delivered as plant stanol esters
15857353|NCT03983603|Dietary Supplement|Placebo soft chew|Soft chew that does not contain plant stanols
15857354|NCT03983590|Other|Visual Analogic Scale|VAS are collected in the first 24 hours after inclusion, 15 minutes, during and 15 minutes after the bed bath. Each time of collection are noted.
15857355|NCT03983577|Other|Point of service delivery model|Participants will receive the pre-test survey, followed by the combined provider/telehealth genetic counseling education video for genetic testing. Afterwards, the participants will receive a post-test and patient satisfaction survey.
15857356|NCT03983564|Other|Cutoff Validation|We will validate the cutoff of the combination of BOSTON score and DES-OSA scores with the result of a polysomnography.
15857357|NCT03983551|Drug|Dipeptidyl Peptidase 4 Inhibitor|Vildagliptin 50 milligrams twice daily in addition to metformin 1000 milligrams once daily
15857358|NCT03983551|Drug|Sulfonylurea|Glimepiride 2 milligrams twice daily in addition to metformin 1000 milligrams once daily
15857359|NCT03983538|Other|Mathematical modeling to predict response to chemotherapy|Mathematical modeling using the patient's diagnostic core biopsy and baseline MRI of the breast will be used to predict the response to above therapy.
15857360|NCT03983525|Dietary Supplement|Goji berry|Those who are eligible for enrollment will be required to participate in three study visits over a three-month period, with each visit lasting approximately one and half hour. The three study visits will be separated by 45 +/- 2 days. During each study period, the participants are required to take 28 grams of goji berry once a day, five times per week, and will complete a set of 24 hour dietary recall, using an online automated self-administered recall system known as the ASA24.
15857361|NCT03983525|Dietary Supplement|Lutein + zeaxanthin supplementation|Those who are eligible for enrollment will be required to participate in three study visits over a three-month period, with each visit lasting approximately one and half hour. The three study visits will be separated by 45 +/- 2 days. During each study period, the participants are required to take one capsule of lutein + zeaxanthin supplementation once a day, five times per week, and will complete a set of 24 hour dietary recall, using an online automated self-administered recall system known as the ASA24.
15857362|NCT03983512|Device|PULSTA TPV System|PULSTA transcatheter pulmonary valve replacement.
15857363|NCT03983499|Behavioral|Special Intervention|The components of the Special Intervention (SI) integrated design are: 1) Co-location of the clinical team; 2) Shared medical plan; 3) Clinical visits with a medical provider for management of chronic medical conditions; 4) Visits with behavioral health provider for management of psychosocial chronic conditions; 5) Care coordination; 6) Six group-health education classes and two booster sessions led by a promotora. Participants in the SI arm meet with the integrated care team in the context of a regular medical visit primarily to focus on clinical/biological aspects of the chronic medical conditions (diabetes, dyslipidemia, hypertension, obesity, etc.)
15857364|NCT03983486|Other|Imaging flow cytometry in multiple myeloma|Combination of immunophenotyping by flow cytometry and FISH in suspension (IS-FISH) may provide both cytogenetic and phenotypic information for a large number of cells in a single test. In this scope, a recent study demonstrated a proof of concept for IS-FISH to detect non pathological signals with the new ImageStream X technology (ISX).1
15857365|NCT03983473|Other|Microbiota Sequencing|virome, bacteriome, fungome NGS sequencing
15857366|NCT03983460|Drug|Dupilumab|Each single used prefilled syringe contains 300 mg of Dupilumab in 2 mL solution (150mg/mL) Dupilumab is a fully human monoclonal antibody against interleukin (IL)-4 receptor alpha that inhibits IL-4/IL-13 signaling, produced in Chinese Hamster Ovary (CHO) cells by recombinant DNA technology.
15857367|NCT03983460|Drug|Optimized TCS treatment|Application of betamethasone valerate 0.1% (Betneval 0.1% cream), a potent topical corticosteroid, and if not active, application of clobetasol propionate 0.05% (Dermoval 0.05% cream), a very potent topical corticosteroid. TCS treatment will be associated with a personal therapeutic education for treatment optimization.
15857368|NCT03983460|Procedure|Biopsies|"Four skin biopsies (5 mm diameter) and ten microbiopsies (2 & 3 mm diameter) will be performed according the following schedule:
~Day 0
~a 5 mm section biopsy from a non-lesional skin
~a 5 mm section biopsy from an active lesion
~a 3 mm section microbiopsies from a non-lesional skin
~a 3 mm section microbiopsies from an active lesion
~a 2 mm section microbiopsies from a non-lesional skin
~a 2 mm section microbiopsies from an active lesion
~Day 28
~a 5 mm section biopsy on improved/healed lesion
~a 3 mm section microbiopsies on improved/healed lesion
~a 2 mm section microbiopsies from non lesional skin identified at V1
~a 2 mm section microbiopsies on improved/healed lesion
~Day 168
~a 5 mm section biopsy on improved/healed lesion
~a 3 mm section microbiopsies on improved/healed lesion
~a 2 mm section microbiopsies from non-lesional skin identified at V1
~a 2 mm section microbiopsies on improved/healed lesion"
15857369|NCT03983460|Procedure|Skin prick-test|"Skin prick test is a method for medical diagnosis of allergy consisting in introducing a small amount of an allergen into the patient's skin. The allergen penetrates the epidermis by pricking the skin with a pin.
~Skin Prick test for Derp and Derf will be performed at Day 0, preferentially on the forearms, avoiding lesional areas.
~For the results interpretation, the two allergen Derp/Derf will be compared to 2 controls:
~Negative control : saline solution
~Positive control : histamine solution
~Positive criteria of prick tests results are:
~Positive control's diameter ≥ 3mm
~And negative control's diameter < 3 mm
~And tested allergen with wheal ≥ positive control, i.e. 3mm"
15857370|NCT03983460|Procedure|Blood sample collection|"A 50ml blood sample will be collected by venipuncture at Day 0, Day 28 and Day 168.
~More specifically a 40 ml blood sample will be drawn on heparinized tubes for immunophenotyping and a 10 mL on serum blood collection tube for analysis of AD biomarkers by mass cytometry and ELISA."
15857371|NCT03983447|Behavioral|School-based intervention to promote PA and reduce ST|"This intervention was realized with all the children (1st grade-5th grade) and involved :
~Physical (Environmental) adaptation of playgrounds
~Time adaptation of lunch breaks
~Curriculum-based program for children
~Workshops and newsletters for parents
~Meetings for teachers"
15857372|NCT03983434|Dietary Supplement|Inulin|Inulin ingestion is not being used to diagnose, treat, or prevent IBS. Inulin is being used to study an individual's ability to ferment dietary fiber.
15857373|NCT03983421|Other|Screening|Screening for Early Psychosis and Clinical High Risk of Psychosis
15857374|NCT03983421|Other|Warm Hand-Off|Among those determined eligible, transfer of care between the student health and counseling center and the coordinated specialty care program outreach coordinator occurring over the phone while the student is in the counselor's office immediately following the results of the screening.
15857375|NCT03983408|Dietary Supplement|Korean Red Ginseng|Participants are provided with 2 Korean Red Ginseng extract tablets twice a day for total 24 weeks.
15857376|NCT03983408|Dietary Supplement|Placebo|Placebo tablets, made of corn starch and cellulose, are manufactured to mimic KRG tablets. Participants are parovided with 2 placebo tablets twice a day for first 12 weeks, following Korean Red Ginseng extract tablets twice a day for another 12 weeks.
15857377|NCT03983395|Biological|ISB 1302 250 ng/kg|ISB 1302 is administered by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. Dose on D1, D8, D15, D22 is 250 ng/kg
15857378|NCT03983395|Biological|ISB 1302 325 ng/kg|ISB 1302 is administered by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at dose levels. Dose on D1, D8, D15, D22 is 325 ng/kg
15857379|NCT03983395|Biological|ISB 1302 325 ng/kg-D1;425 ng/kg -D8,D15,D22|ISB 1302 is administered by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at escalating dose levels. Dose of ISB 1302 is 325 ng/kg on D1 and 425 ng/kg on D8, D15, D22
15857380|NCT03983395|Biological|ISB 1302 325 ng/kg-D1;550 ng/kg -D8,D15,D22|ISB 1302 is administered by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at escalating dose levels. Dose of ISB 1302 is 325 ng/kg on D1 and 550 ng/kg on D8, D15, D22
15857381|NCT03983395|Biological|ISB 1302 325ng/kgD1;550 ng/kg D8;700 ng/kgD15,22|ISB 1302 is administered by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at escalating dose levels. Dose of ISB 1302 is 325 ng/kg on D1 and 550 ng/kg on D8, and 700 ng/kg on D15, D22
15857382|NCT03983395|Biological|ISB 1302 325ng/kg D1;550 ng/kg D8;900 ng/kg D15,22|ISB 1302 is administered by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at escalating dose levels. Dose of ISB 1302 is 325 ng/kg on D1 and 550 ng/kg on D8, and 900 ng/kg on D15, D22
15857383|NCT03983395|Biological|ISB 1302 escalating doses,1200 ng/kg D15,22|ISB 1302 is administered by intravenous (IV) infusion on Day 1, Day 8, Day 15, and Day 22 of each 28-day treatment cycle at escalating dose levels. Dose of ISB 1302 is 325 ng/kg on D1 and 700 ng/kg on D8, and 1200 ng/kg on D15, D22
15857384|NCT03983395|Biological|ISB 1302 at the MTD and/or RP2D dose|ISB 1302 at the MTD and/or RP2D dose in separate groups in the Q1W and/or the Q2W dose regimen.
15857385|NCT03983382|Diagnostic Test|Left Ventricular Ejection Fraction|LVEF assessment at baseline, 6 months, and 12 months
15857386|NCT03983369|Device|Low-Level Laser Therapy|The LLL used is the K-Laser Cube 3. The LLL is an athermal laser beam of low power, equipped with a placebo function (dummy imitating beam laser light, emitted by the same device but without physiological effect).
15857387|NCT03983369|Other|Placebo|Placebo
15857388|NCT03983356|Other|Training program|An internet based training program will be offered to GPs. We will also offer face-to-face seminars with academic psychiatrists.
15857389|NCT03983343|Device|Derma+flex®QSTM|Perineal skin will be closed by adhesive glue - Derma+flex®QSTM (Octyl-2-cyanoacrylate).
15857390|NCT03983330|Behavioral|Brief Motivational Interviewing (i-BMI)|"The trained RA will ask the subjects about the priority of engaging in any desirable health-related lifestyle practice as identified in the completed baseline questionnaires and to state a targeted goal that they perceive as the easiest to achieve. Each subject will then receive an individual face-to-face brief MI (about 5 mins) with generic health advice on selected health-related lifestyle practice. They will then be informed to receive an individual brief MI intervention to assist behavioural changes or achieve goals as desired or chosen by them via WeChat or WhatsApp in smart phones throughout the study period. They will be given a self-help smoking cessation booklet with Hotline number.
~The RA will then deliver brief MI to each subject individually via WeChat or WhatsApp in smart phones throughout the study period.
~Readiness of quitting smoking will be assessed at 3-month follow-up. Upon request by subjects, we shall provide them with more comprehensive information on quitting."
15857391|NCT03983330|Behavioral|Control|Similar to the intervention group, the trained RA will first ask the subjects about the priority of engaging in any desirable health-related lifestyle practice and to state a targeted goal in which they perceive as the easiest to achieve after completing the baseline questionnaires. In addition, the subjects will be given a self-help smoking cessation booklet with Hotline (Tel.: 1833183). However, subjects in the control group will not receive brief MI and follow-up booster intervention. Subjects will be informed that they will receive follow-up telephone call at 1, 3, 6 and 12 months.
15857392|NCT03983317|Device|Empower Neuromodulation System|Transcutaneous electrical nerve stimulation
15857393|NCT03983304|Device|The ZELTIQ System|The EMS device will be used to perform the treatments.
15857394|NCT03983291|Behavioral|FaReWell Depression|Facial massage and force exercise
15857395|NCT03983278|Other|School Model|Free delivery of glasses at the school within two weeks after screening
15857396|NCT03983278|Other|Referral Model|After the primary screening children referred to nearby Vision Center/ secondary center for refraction and delivery of free glasses.
15857397|NCT03983278|Other|Referral Model + Cost Recovery|"After the screening children referred to Vision Center for refraction and delivery of free glasses with the option to purchase upgrade glasses"
15857398|NCT03983265|Other|Bilateral Sagittal Split Osteotomy|after BSSO condyle will be re positioned by using computer guided device
15857403|NCT03983226|Procedure|Surgery|Tumor debulking surgery (surgery in recurrent ovarian disease)
15857404|NCT03983226|Drug|carboplatin/taxane, carboplatin/gemcitabine, cisplatin/gemcitabine, liposome doxorubicin/carboplatin...|Salvage chemotherapy
15857405|NCT03983226|Drug|Niraparib|Niraparib maintenance therapy
15857406|NCT03983213|Procedure|mpfl reconstruction|Harvested gracilis tendon is pulled through patella and femur in anatomic position and locked with interference screw.
15857407|NCT03983200|Device|Rotating Magnetic Therapy|Rotating Magnetic Therapy 30min, bid
15857408|NCT03983200|Drug|Mecobalamin|mecobalamine 0.5mg,tid
15857409|NCT03983187|Device|Rotating Magnetic Therapy|Rotating Magnetic Therapy 30min/ Bid for 1 month
15857410|NCT03983174|Procedure|Drainage seton with flap|Seton is placed around the external sphincter then mucosal advancement flap will be constructed
15857411|NCT03983174|Procedure|EAS sparing seton|Rerouting of the seton around the internal sphincter only sparing the external sphincter
15857412|NCT03983161|Drug|Fedratinib|Fedratinib
15857413|NCT03983148|Behavioral|Motivational interviewing|There are 3 sessions. Each session is an about 60-minute individual motivational interviewing held by a trained registered nurse. The first session aims to develop an action plan that enables the parents to promote physical activity (PA) for their children. The second session targets to review the adherence to the action plan. The nurse will discuss the progress. In the last session, the aim is to motivate the parents promoting PA for their children in the long run. As such, the benefits of PA throughout the survivorship will be emphasized. And the nurse will work with the parents to identify the resources that can help maintain the designed action plan.
15857414|NCT03983148|Behavioral|Placebo control|"Other than usual medical care received by children, parents in this group will receive an individual, face-to-face intervention which mimics the time and attention received by those in the experimental group. The intervention includes three sessions of educational talk to parents of children with cancer on healthy diet for cancer patients, adverse effects of cancer treatment, methods to minimize adverse effects.
~Subjects in both groups will receive a booklet developed by the advisory committee, which contains a various kind of physical activities specially designed for children with cancer."
15857415|NCT03983135|Other|Laparoscopic mini gastric by-pass|Adhesions will separated along the left edge of the stomach and the left lobe of the liver. The remnant stomach will transected at the incisura angularis level with 60 mm Endo-GIA stapler(ATW 35, EthiconEndo-SurgeryInc., Cincinnati, OH, USA). Later ante-cholic distal of the Treitz ligament hadgastro-jejunal anastomosisof nearly 150 cm jejunal loop performed with 44 mm Endo-GIA stapler. Routinely, the omentum will be divided in two and omentopexy will be performed around the anastomosis. The stapler line will supported by absorbable stitches.
15857416|NCT03983135|Other|LaparoscopicRe-sleeve gastrectomy|Adhesions will be separated with blunt and sharp dissections, then the remnant stomach will completely freed. Due to dilated antral pouch or fundus, the remnant stomach will resect as a tube stomach between the pillory and left crus with 60 mm Endo-GIA stapler accompanied by 36F bougie.
15857417|NCT03983135|Other|Laparoscopic Roux-en-Ygastric bypass|all adhesions will separated then after the stomach pouch will formed by the linear stapler, 100 cm of jejunum will transected from the Treitz ligament. Side-to-side gastrojejunostomy will performed for the distal jejunum with the linear stapler. The anterior face of the anastomosis will manually sutured. Proximal jejunum end hadside-to-side jejuno-jejunostomy performed 150 cm distal of the gastrojejunostomy anastomosis with linear stapler on the posterior wall and manual suturing of the anterior wall.
15857418|NCT03983122|Procedure|Laparoscopic sleeve gastrectomy|Each procedure will be completed with laparoscopy with five trocars. A 36F bougie will used to calibrate the volume of the remnant stomach. Linear gastrectomy will begin 2 cm proximal of the pylor and will continue until the gastroesophageal junction. According to the intraoperative decision and experience of the surgeon, endoscopic clips would be used to ensure hemostasis of the stapler line.
15857419|NCT03983109|Device|EpiFaith loss of resistance detect syringe|An EpiFaith syringe will be used to detect the loss of resistance and facilitate the needle localization.
15857420|NCT03983083|Behavioral|Physical activity|Access to website created to teach cancer survivors to live more active lives, with monthly email reminders/website updates. Intervention participants will also receive exercise bands for at-home resistance training.
15857421|NCT03983070|Other|Seated Rowing Ergometer|Seated rowing exercise performed at a specific percentage of maximal Watts according to pre-intervention measures
15857422|NCT03983070|Other|Deadlift|Deadlift exercise performed with a set of dumbbell weights at a sepcific percentage of pre-intervention one-repetition maximum.
15857423|NCT03983070|Other|Blood flow restriction|An occlusive cuff will be placed around each proximal thigh and inflated to 80% arterial occlusion during exercise sessions.
15857424|NCT03983057|Drug|Anti-PD-1 monoclonal antibody|Accompanying with modified-FOLFIRINOX, Anti-PD-1 antibody was applied biweekly.
15857425|NCT03983031|Drug|Rituximab|Infusion
15857426|NCT03983018|Drug|Rituximab|Infusion
15857427|NCT03983005|Procedure|EUS-B-FNA|Endoscopic ultrasound with bronchoscope fine needle aspiration (EUS-B-FNA) is an endoscopic technique based on a trans-esophageal needle aspiration performed by an interventional pulmonologist with the echo-bronchoscope
15857428|NCT03982992|Drug|Blinatumomab in combination with donor lymphocyte infusion|Continuous blinatumomab infusion in combination with allogeneic donor lymphocyte infusion
15857429|NCT03982979|Device|HM3 LVAS|HeartMate® 3 (HM3) Left Ventricular Assist System (LVAS)
15857430|NCT03982966|Dietary Supplement|Omega 3 fatty acids (fish oil) 1000 mg/day oral|Omega 3 fatty acids (fish oil) 1000 mg/day oral
15857431|NCT03982940|Device|BGP+ Stent Graft System as bridging stent|BGP+ Stent Graft System as bridging stent
15857432|NCT03982927|Other|Laparoscopic skills workshop|One day laparoscopic skills workshop was offered to the surgical residents
15857433|NCT03982901|Diagnostic Test|Mental Stress Test|In this study, we compare MSIMI prevalence in the two groups (chest pain group and no chest pain group). Each subject in both groups receive the same mental stress test process, and the mental stress test process have 3 consecutive stress tests, which including: Stroop Color-Word test; Public speaking with anger recall test and Mental arithmetic test.
15857434|NCT03982888|Procedure|Deep Brain Stimulation|Stimulation of the nucleus accumbens via 2 electrodes implanted in the brain per patient to reduce self-injurious behaviours.
15857656|NCT03981133|Behavioral|no pacifier|not to offer a pacifier at 15 days of life
15857435|NCT03982888|Device|DBS|"Use of the Medtronic DBS device. DBS device consists of 2 parts:
~DBS lead, a thin wire with 2 electrical contacts implanted into pre-determined brain regions, and
~Implantable pulse generator, a small device containing the batter and computer source placed under the skin of the chest to generate electrical pulses"
15857436|NCT03982875|Device|Alfred SmartBag|The Alfred SmartBag encompasses a pouch, a baseplate, and a hub, is intended to be used as a continuous ostomy monitoring system by tracking the volumetric filling of the pouch through integrated thermistor and capacitive sensors and potential leakage and skin irritation development through integrated thermistors in the wafer. The Alfred SmartBag system is indicated for daily use for both in-patient and out-patient settings to provide information to patient and medical professionals. The data is intended to aid patient self-management and to alert the clinical team to changes in the patient condition that may warrant specific intervention.
15857437|NCT03982862|Drug|Triamcinolone|Triamcinolone 4mg diluted to 0.1 ml
15857438|NCT03982862|Drug|Lidocaine|0.1ml 2% Xylocaine
15857439|NCT03982862|Drug|Botulinum toxin A|4U Botox® diluted to 0.1 ml
15857440|NCT03982849|Drug|Hydroquinone 4% Cream|Hydroquinone is tyrosinase inhibitor and thus inhibits melanogenesis.
15857441|NCT03982849|Drug|silymarin 0.7% cream|Silymarin is a plant derived flavonoid, extracted from fruits and seeds of milk thistle.
15857442|NCT03982836|Dietary Supplement|Soluble Dietary Fibers|All 25 volunteers received, were separated for 7 days of washout, one containing maltodextrin (control), Frutooligossacharide or guar gum partially hydrolyzed in a randomized manner. As the partially hydrolyzed guar gum and fructooligosaccharide, soluble dietary fibers that present different behaviors in the body.
15857443|NCT03982823|Procedure|Hand-Sewn Sleeve Gastrectomy|After laparoscopic sleeve gastrectomy, gastrectomy site is hand-sewn with 3/0 polypropylene suture and the specimen is removed transorally.
15857444|NCT03982823|Procedure|Stapled Sleeve Gastrectomy|Laparoscopic sleeve gastrectomy is performed via 60 mm linear stapler (Endo GIATM Ultra, Covidien) .
15857445|NCT03982810|Drug|Antibiotics|Antibiotic prophylaxis and the occurrence of a NSQIP-adjudicated SSI during the period from 2011 to 2018. SSIs will be a composite of superficial (only skin or subcutaneous tissue of the incision), deep (deep soft tissues), and organ space (any part of the anatomy other than the incision, which has been opened and manipulated during the operation), as provided by the NSQIP.
15857446|NCT03982797|Biological|Instillation of IMUNO BCG Moreau RJ|Instillation in bladder will be done once per week during first six weeks after inclusion, and 3 instillations (one per week) on month three, another three on moth six and last three on month twelve .
15857447|NCT03982784|Procedure|single-injection TQLB(transmuscular quadratus lumborum block)|Inject 0.6ml/kg local anesthetics in between quadratus lumborum and psoas major under ultrasound guidance
15857448|NCT03982784|Drug|Morphine given as IPCA(intravenous patient controlled analgesia)|PCIA was initiated using a pump set to deliver boluses of 1.5-2 mg of morphine with a 5-minute lockout interval and no background infusion. The maximal permitted dosage of morphine was set at 8 mg/h.
15857449|NCT03982771|Drug|Bortezomib|-Bortezomib: 1.3mg/m2 subcutaneous injection on Day 1,8,15,22 every month for 9 months; And maintained with 1.3mg/m2 subcutaneous injection every two weeks from Month 9 to 21;
15857450|NCT03982771|Drug|Cyclophosphamide|-Cyclophosphamide: (oral) 300mg/m2 on Day 1, 8, 15, 22 every month for 9 months;
15857451|NCT03982771|Drug|Dexamethason|Dexamethasone: (oral) 40mg on Day 1,8,15,22 every month for 9 months; and maintained with 20mg (oral) every two weeks from Month 9 to 21.
15857452|NCT03982758|Other|isometric handgrip exercise|Isometric session with handgrip: 4 sets of 2 minutes of contractions sustained at 30% of CVM, for each arm. The time between sets and between arms will be 1 minute rest.
15857453|NCT03982758|Other|isometric of the lower limbs|Isometric session for lower limbs: 4 sets with 2 minutes of contractions sustained at 30% of 1RM. The rest interval will be 1 minute rest.
15857454|NCT03982745|Device|bonfils|bonfils intubation
15857455|NCT03982732|Biological|Boostrix-IPV|Receipt of Boostrix IPV at three different gestational time periods
15857456|NCT03982719|Other|Brief protocol|This protocol consists of 4 intervention sessions with an occupational therapist specialized in hand therapy that will occur at 0-3 days, 2 weeks, 4 weeks and 8 weeks post-fasciectomy. The occupational therapist will give recommendations about the management of swelling, wound care and functional recovery. An home exercises program will be given to the participant. The occupational therapist will make an extension splint that should be worn at night for the 3 months following surgery.
15857457|NCT03982719|Other|Intense protocol|This protocol consists of 6 intervention sessions with an occupational therapist specialized in hand therapy that will occur at 0-3 days, 2 weeks, 3 weeks, 4 weeks, 6 weeks and 8 weeks after surgery. The occupational therapist will give recommendations about the management of swelling, wound care and functional recovery. An home exercises program will be given to the participant. The occupational therapist will make an extension splint that should be worn at night for the 3 months following surgery. Also, exercises will be performed by the patient under the supervision of the occupational therapist (supervised exercises) in each session except the first one at 0-3 days after surgery.
15857458|NCT03982693|Drug|Edetate Disodium|The solution contains up to 3 g of edetate disodium adjusted based on creatinine clearance, 2 g of magnesium chloride, 100 mg of procaine hydrochloride, 2500 U of heparin, 7 g of ascorbate, 2 milliequivalent (mEq) potassium chloride (KCl), 840 mg sodium bicarbonate, 250 mg pantothenic acid, 100 mg of thiamine, 100 mg of pyridoxine, and sterile water to complete 500 mL.
15857459|NCT03982693|Other|Placebo|Placebo infusions consist of 500 ml normal saline.
15857460|NCT03982680|Drug|Toripalimab|3mg/kg on d1 and d15 q4W*4cycles，then 3mg/kg q3w for 1 year in total
15857461|NCT03982680|Drug|Gemcitabine|1250mg/m2 on d1 and d15 q4W*4cycles
15857462|NCT03982680|Drug|5- fluorine pyrimidine|400mg/m2 intravenous injection plus 5-FU 2.4g-3.6g/m2 continuous intravenous drip for 48h on d1 and d15 q4W*4cycles
15857497|NCT03982368|Drug|rhNGF 20 μg/ml|one drop of rhNGF 20 μg/ml will be instilled in both eyes three times daily (every 6-8 hours)
15857498|NCT03982368|Drug|rhNGF 20 μg/ml + vehicle|"one drop of rhNGF 20 μg/ml will be instilled in both eyes two times daily plus one drop (40 μL) of vehicle will be instilled in both eyes once daily (every 6-8 hours).
~rhNGF will be instilled in the morning and in the evening while the vehicle will be instilled in the afternoon."
15857499|NCT03982368|Other|Vehicle|one drop of vehicle will be instilled in both eyes three times daily (every 6-8 hours)
15857463|NCT03982667|Diagnostic Test|PCT-guided group|In the PCT-guided group, the study protocol encourages to stop the prescribed antibiotics if PCT concentration decrease by 80% or more of its peak value (or if PCT concentration is ≥0·25 and <0·5 μg/L), and strongly encourage to stop the prescribed antibiotics when it reaches a value of < 0·25 μg/L. The attending physician is free to decide whether to continue antibiotic treatment in patients who reach these thresholds. Reasons for non-adherence will be recorded. Antibiotics in the standard-of-care group will be stopped according to local or national guidelines and according to the discretion of attending physicians. Patients will be followed-up until hospital discharge.
15857464|NCT03982654|Device|Bloomlife|Women use the Bloomlife sensor to collect data throughout their pregnancy. The collected data is stored locally in the device, but it is not used to provide any feedback to the patients or to the clinical team. Therefore the use of the device doesn't have an impact on clinical decision making and patients' care.
15857465|NCT03982641|Procedure|all colorectal cancer surgical procedures|colorectal cancer surgical procedures
15857466|NCT03982628|Diagnostic Test|Abdominal CT imaging|Routine abdominal CT imaging
15857467|NCT03982615|Device|Laser-Lok abutment|"Each subject will receive two dental implants. One implant will receive (by randomization) a laser-etched (Laser-Lok) abutment."
15857468|NCT03982615|Device|Standard healing abutment|Each subject will receive two dental implants. One implant will receive (by randomization) receive a standard healing abutment (not laser-etched).
15857469|NCT03982602|Drug|Ketogenic diet|Subjects will be provided with the Ketogenic diet in the form of tube feeds once the decision is made to start the patient on diet.
15857470|NCT03982576|Other|Nicotine replacement therapy (NRT)|4 weeks of Transdermal nicotine patches or nicotine gum
15857471|NCT03982576|Behavioral|CS-CBT intervention|4 group sessions of a novel culturally specific, CBT-based intervention over 2 weeks
15857472|NCT03982576|Behavioral|Path2Quit|Path2Quit is a newly developed video-text program, which delivers 6 weeks of CS video messages (1-2 times/day) and provides 24/7 access to messages pulled from 3 keywords (HELP1, JONES, SLIP).
15857473|NCT03982576|Behavioral|Relapse prevention program|4 group sessions of a standard relapse prevention program, publicly available at smokefree.gov
15857474|NCT03982576|Behavioral|SmokefreeTXT|NCI's 6-week fully automated text-based cessation program that is free to U.S. subscribers, and is available on smokefree.gov. Users can text one of 3 keywords (MOOD, CRAVE, or SLIP) to receive a relevant message from the system 24/7
15857475|NCT03982563|Behavioral|Growth Mindset|Reading and writing activities designed to instill the belief that people can change.
15857476|NCT03982563|Behavioral|Gratitude|Reading and writing activities designed to practice noticing and appreciating good things in life.
15857477|NCT03982563|Behavioral|Behavioral Activation|Reading and writing activities designed to identify and schedule positive activities.
15857478|NCT03982563|Behavioral|Study Skills|Reading and writing activities designed to learn evidence-based study strategies.
15857479|NCT03982550|Behavioral|Periodized Resistance Training|Mesocycle I (weeks 1-4) will emphasize muscular hypertrophy to develop a muscular and metabolic base for more intense training in later phases. Training bouts will consist of 4-6 resistance exercises with 2-4 sets per exercise and 8-10 repetitions per set. Mesocycles II (weeks 5-8) and III (weeks 9-12) will emphasize strength development. Training bouts will consist of 4-6 resistance exercises with 3-5 sets per exercise, 4-6 repetitions per set, and linear increases in intensity over time. These parameters were chosen to maximize performance on 4-6 repetition maximum (RM) testing post-intervention, according to the principle of specificity - i.e. specific adaptation to imposed demands.The training loads used will be individually progressed in a safe and effective manner, in order to employ a progressive overload/challenge to the neuromuscular system and elicit the greatest training-induced neuromuscular adaptations possible.
15857480|NCT03982537|Drug|N-Acetyl-L-Cysteine dietary supplement|Treatment will be administered on an outpatient basis, either twice daily or 48 hours prior to starting chemotherapy radiation. Eligible participants will start NAC at least 9 days before definitive or adjuvant radiation therapy.
15857481|NCT03982537|Radiation|Chemotherapy and Radiation|Participants will receive definitive or adjuvant concurrent chemotherapy and radiotherapy s per standard of care.
15857482|NCT03982524|Behavioral|Cognitive-behavioral therapy + emotion regulation training for patients with multiple somatoform symptoms|Cognitive-behavioral therapy + emotion regulation training for patients with multiple somatoform symptoms: 20 weekly sessions individual therapy (à 50 minutes)
15857483|NCT03982524|Behavioral|Cognitive-behavioral therapy for patients with multiple somatoform symptoms|Cognitive-behavioral therapy for patients with multiple somatoform symptoms: 20 weekly sessions individual therapy (à 50 minutes)
15857484|NCT03982511|Behavioral|PCIT-Health|PCIT-Health (also known as Parents Active in Their Children's Health; PATCH) is an adaptation of Parent-Child Interaction Therapy. PCIT-Health targets (1) the parent-child relationship and (2) parenting efficacy both in general contexts (child play time and clean up time) and specifically in the context of obesity risk-related behaviors (child feeding, family mealtime, and child screen time).
15857485|NCT03982485|Drug|Apatinib|Apatinib 250mg, Oral, day 2,3,4,5,6,7, every week
15857486|NCT03982485|Drug|Paclitaxel|Paclitaxel 80mg/m2, Intravenous, day 1, 8, 15, 22, every 28 days for a cycle
15857487|NCT03982485|Drug|Cisplatin|Cisplatin 25mg/m2, Intravenous, day 1, 8, 15, every 28 days for a cycle
15857488|NCT03982485|Procedure|Surgery|Surgery
15857489|NCT03982472|Other|transcutaneous electric stimulation|transcutaneous current with an amplitude around ten to hundred milliampere was applied topically to subjects
15857490|NCT03982459|Behavioral|decision support tool|computerized online decision support tool
15857491|NCT03982446|Genetic|Mutations|
15857492|NCT03982433|Behavioral|Motivation and Cognitive Behavioral Management for Alcohol and Pain|Behavioral intervention that includes motivational, cognitive, and behavioral intervention strategies to reduce heavy drinking and chronic pain interference
15857493|NCT03982420|Procedure|Transcarotid Revascularization (TCAR)|Carotid revascularization treated with the FDA-cleared ENROUTE Transcarotid NPS in conjunction with the FDA-approved ENROUTE Transcarotid Stent
15857494|NCT03982407|Drug|68Ga-PSMA-11 PET/MRI|The PET/MRI exam-related patient visit will last approximately 2 to 2.5 hours, including 30-minute nursing assessment, 45-60 minutes for PSMA uptake and 60 minutes for PET/MRI scan. They will be contacted within the next 72 hours to complete a brief phone survey.
15857500|NCT03982355|Device|DRS probe|The Oxygenation measurements of the novel diffuse reflectance spectroscopy probe
15857501|NCT03982342|Device|Cather closure of patent ductus arteriosus (PDA)|Infants assigned to this group will have a catheter run from a blood vessel in the upper leg / groin area to the heart, where an FDA-approved device will be placed within the patent ductus arteriosus to occlude or plug it, thereby closing the ductus.
15857502|NCT03982342|Other|Conservative management of patent ductus arteriosus (PDA)|"Infants with a hemodynamically-significant patent ductus arteriosus randomized to this group will be treated by fluid restriction and possible diuretic use to reduce PDA symptoms, and allow time to permit the PDA to close or become reduced in size to the point where it is no longer considered hemodynamically-significant."
15857503|NCT03982329|Device|navigated repetitive transcranial magnetic stimulation|
15857504|NCT03982329|Procedure|physical therapy|
15857505|NCT03982316|Behavioral|Telehealth Behavioral Migraine Management|1) Weekly online modules; 2) Monthly 50 minute telephone calls; 3) 3 15-minute telephone check ins.
15857506|NCT03982303|Drug|Hemay102|Hemay102 was administered through i.v. infusion for 4hrs.
15857507|NCT03982290|Other|Probiotic, Lactobacillus plantarum PS128|PS128 capsules, 2 capsules per day
15857508|NCT03982290|Other|Placebo, microcrystalline cellulose|Placebo capsules, 2 capsules per day
15857509|NCT03982277|Drug|Rifampin 300 Mg Oral Capsule|High dose rifampicin at 35mg/kg
15857510|NCT03982264|Procedure|ESD procedure|ESD were all performed as the standard procedure that has been widely described and used. A diluted sodium hyaluronate solution was injected submucosally. Mucosal incision and submucosal dissection were performed by using either Hook knife (Olympus Medical, Japan) or a dual-knife (Olympus Medical, Japan) . After the resection was finished, all of the visible vessels on the artificial ulcer bed were thoroughly coagulated with argon plasma coagulation to prevent postoperative bleeding.
15857511|NCT03982264|Procedure|EMR-C procedure|A transparent cap (MH-593; Olympus) was attached to the forward-viewing endoscope. After the endoscope was inserted to the rectum, the snare passed through the sheath and was looped along the inner lip of the cap. The tumor was then suctioned into the cap and the snare was pushed off and closed. After confirming the appropriate snare placement, both the tumor and the overlying mucosa were resected by electric cautery (Endocut Q, effect 2, VIO 200D; ERBE, Tübingen, Germany), and then the removed tumor was sent for pathological examination. Endoscopic examination then was repeated without the transparent cap in order to evaluate the wound carefully in case there was any perforation or bleeding and to ensure the absence of the residual tumor tissues. If there was spurting bleeding or active bleeding, hot forceps were usually to stop the bleeding.
15857512|NCT03982251|Procedure|High frequency whole body vibration|1 single session ( 8 minutes) of whole body vibration therapy at 30 Hz
15857513|NCT03982251|Procedure|Low frequency whole body vibration|1 single session ( 12 minutes) of whole body vibration therapy at 20 Hz
15857514|NCT03982238|Drug|Insulin|Continuous subcutaneous insulin infusion therapy for 1 month
15857515|NCT03982238|Drug|Metformin|Continuous subcutaneous insulin infusion plus metformin (at least1000mg/day) for 1 month
15857516|NCT03982238|Drug|Dapagliflozin|Continuous subcutaneous insulin infusion plus metformin (10mg/day) for 1 month
15857517|NCT03982225|Drug|Polyene phosphatidylcholine injection|Formulated as an injectable solution containing Polyene Phosphatidylcholine at two concentration of 25 mg/mL and 50 mg/mL.
15857518|NCT03982225|Drug|Placebo|Phosphate buffered saline placebo for injection
15857519|NCT03982212|Drug|Copaxone|"Agent: Glatiramer acetate (Copaxone®)
~Dose: 40 mg
~Route: Intratumoral injection
~Schedule: At least 1 dose, up to 3 doses, with each dose being at least 48 hours apart and last dose within 96 hours of standard of care surgery."
15857527|NCT03982173|Drug|Tremelimumab|tremelimumab 75mg
15857528|NCT03982173|Drug|Durvalumab|Durvalumab 1500mg
15857529|NCT03982160|Drug|L-Arginine|Arginine Hydrochloride 60% concentration injection 15 g in 25 mL, contains arginine hydrochloride 600 mg/mL in water for injections to 25 mL.
15857530|NCT03982160|Other|Placebo|Saline
15857531|NCT03982134|Drug|PDR001|PDR001 is a humanized IgG4 antibody
15857532|NCT03982134|Drug|Panobinostat|Panobinostat is a Histone deacetylase inhibitor (HDACi).
15857533|NCT03982121|Drug|FOLFOX regimen|Oxaliplatin 85 mg/m² Leucovorin (LV) levogyre form (LLV) 200 mg/m² or dextro-levogyre (DL-LV) racemic mixture 400 mg/m²) Fluorouracil 2400 mg/m²
15857534|NCT03982121|Drug|Nivolumab|Nivolumab 240 mg
15857535|NCT03982121|Drug|Ipilimumab|Ipilimumab 5 or 10 or 25 mg
15857536|NCT03982121|Drug|GLA-SE|GLA-SE 1 or 2 or 5 or 10 or 20 μg
15857537|NCT03982108|Procedure|Arthroscopic rotator cuff repair with knotless suture-bridge technique|"A posterior portal will be established to obtain adequate visualization and an anterior portal will be established through rotator interval as a working portal for diagnostic arthroscopy and debridement. Then additional portals will be established and preperation of tendon will be performed and a burr will be used for footprint preperation.
~After determination of proper anchor locations, required number of suture anchors will be inserted just lateral to articular margin depending on the tear size. Then limbs of sutures will be passed from the rotator cuff and will be used to create a suture bridge over the tendon. Then these limbs will be loaded to anchors which will form the lateral row without tying the suture limbs at the medial row. These lateral anchors will be inserted to adequate location, just lateral and distal to greater tuberosity with adequate suture-bridge tension over the rotator cuff."
15857771|NCT03980184|Other|Behavioral Counseling|placebo
15857538|NCT03982108|Procedure|Arthroscopic rotator cuff repair with knot-tying suture-bridge technique|After the same preparation procedure as in knotless suture-bridge technique, required number of suture anchors will be inserted just lateral to articular margin depending on the tear size. Then limbs of sutures will be passed from the tendon and tied in a horizontal mattress suture pattern. After the establishment of medial row, suture limbs will be used to form a suture bridge over the tendon and will be loaded to lateral row anchors which then will be inserted lateral to greater tuberosity in a similar way to knotless repair technique.
15857539|NCT03982082|Procedure|Physical Therapy|Undergo physical therapy
15857540|NCT03982082|Other|Questionnaire Administration|Ancillary studies
15857541|NCT03982082|Procedure|Ultrasound|Undergo ultrasound via MuscleSound technology
15857542|NCT03982069|Biological|FluMist live attenuated influenza vaccine|Participants randomized to this study influenza vaccine arm will receive FluMist live attenuated influenza vaccine at baseline after the baseline blood draw is complete.
15857543|NCT03982069|Biological|Flucelvax inactivated influenza vaccine|Participants randomized to this study influenza vaccine arm will receive Flucelvax cell-culture inactivated influenza vaccine at baseline after the baseline blood draw is complete.
15857544|NCT03982056|Other|this is an observational study there are no interventions|development of an index to provide appropriate information on a person's ability to float, based on Physiological and anthropometric characteristics
15857546|NCT03982030|Drug|Dalbavancin|Dalbavancin 1.5g IV at day 0, day 8-10
15857547|NCT03982017|Other|Mobile Health Technology Platform|When the participant navigates to the program, s/he will follow the directions on how to use the program, sign the terms of agreement, put in a password and begin the welcome page. The participant will receive daily prompts to complete brief questionnaires and review specialized content.
15857548|NCT03982017|Other|Usual care|Routine care at the time of hospital discharge, to be provided at the discretion of the clinicians caring for the participant.
15857549|NCT03982004|Device|Epicutaneous cryoimmunotherapy|Epicutaneous cryoimmunotherapy (EC) treatment includes liquid nitrogen cryotherapy applied for 10 seconds x 2 freeze-thaw cycles. Four treatment areas will be chosen at each treatment.
15857550|NCT03982004|Drug|Topical imiquimod|Patients will apply the cream directly over the treatment areas and can use up to one packet per day (covers approximately 5 cm x 5 cm).
15857551|NCT03982004|Drug|Pembrolizumab|Pembrolizumab 200 mg will be administered as a 30 minute IV infusion
15857552|NCT03982004|Other|Dermatologic Quality of Life Index|"10 questions about how much skin problems has affected the participant's life over the past week
~The scoring of each question is as follows: very much = 3, a lot = 2, a little = 1, not at all = 0, not relevant = 0, and question #7 'prevented work or studying' = 3
~The DLQI is calculated by summing the score of each question resulting in a max of 30 and min of 0. The higher the score, the more quality of life is impaired."
15857553|NCT03982004|Other|Functional Assessment of Cancer Therapy|"5 subscales (physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns)
~Answers ranging from 0=Not at all to 4 = very much
~Each item is rated on a 5-point Likert scale.
~The higher the score on the social/family well-being and functional well-being indicate higher quality of life
~The lower the score on physical well-being, emotional well-being, and additional concerns indicate higher quality of life"
15857554|NCT03982004|Drug|Intra-lesional GM-CSF|250 mcg every 2 weeks x 3 doses then every 3 weeks for 3 doses
15857555|NCT03982004|Device|Cry-AC|-Device used to give the cryoimmunotherapy
15857556|NCT03982004|Procedure|Cutaneous tumor biopsy|-Baseline, week 3 (prior to 1st dose of pembrolizumab), week 9, and at week 18. An optional biopsy can be obtained at the time of disease progression.
15857557|NCT03982004|Procedure|Peripheral blood draw for research|-Baseline, week 3 (prior to 1st dose of pembrolizumab), week 9, and at week 18. An optional biopsy can be obtained at the time of disease progression.
15857558|NCT03981978|Behavioral|Physical Activity|Self-report questionnaires assessing physical activity level.
15857559|NCT03981965|Other|Physical activity|Physical activity as described previously.
15857565|NCT03981939|Other|No intervention|This is an observational study, participants did not receive any intervention in this study and were only observed retrospectively.
15857566|NCT03981926|Other|Team-Based Connected Health (TCH)|TCH is an asynchronous, secure online platform where patients can upload images of atopic dermatitis disease and submit assessments. Likewise, practitioners can request and/or initiate dermatology consultations, assume longitudinal care or communicate with patients directly.
15857625|NCT03981432|Behavioral|REST-AdLib|condition without exercise / rest condition. The participants will be asked to remain quiet and at rest during the morning and will receive an ad libitum meal at lunch. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.
15857626|NCT03981432|Behavioral|EX-AdLib|condition with an acute exercise set 30 minutes before the lunch meal that will be served ad libitum This will be a 30-minute exercise set at 65% of their capacities (cycling), 30 minutes before lunch.
15857627|NCT03981419|Biological|GRF6021|for IV infusion
15857567|NCT03981913|Behavioral|Simon Task with high-density EEG recording|"The scalp electrical activity will be collected by a 256-electrodes EEG montage (Electrical Geodesics Inc).
~During the task, participants will be asked to answer on a right or left button according to the color of a circle (yellow or blue) presented on the left or right side of a screen. Participants will have to ignore the stimulus position and respond only according to its color. This leads to two experimental conditions When the color of the circle and its position indicate the same answer, the situation is congruent and the answer is facilitated. Conversely, when they indicate two opposite responses, a conflict between the two alternative actions appears and must be resolved to provide a correct answer. This situation is said to be incongruent. At each trial, the stimulus is shown to the left or right of a central fixation cross. The participants then have to answer on a right or left button. At each trial, the reaction time and the accuracy of the response will be collected."
15857568|NCT03981900|Drug|Tofacitinib|5 mg BID, oral administrtaion
15857569|NCT03981887|Drug|Nafithromycin|Nafithromycin 200 mg as IV infusion
15857570|NCT03981887|Other|Placebo|placebo administered as IV infusion
15857571|NCT03981874|Other|telephonic interview|Telephonic interview
15857572|NCT03981861|Drug|Metformin and Spironolactone|Oral Metformin tablet (500 mg/tablet) twice daily for 6 months. Oral Spironolactone tablet (50 mg/tablet) once daily for 6 months.
15857573|NCT03981848|Other|Risk model of tumor relapse|High risk factor model of tumor relapse after liver transplantation
15857574|NCT03981822|Combination Product|VP-102 and applicator|In part A, VP-102 will be applied for either 2, 6 or 24 hours with each regimen compared to placebo. For part B, 2 of the regimens from part A will be chosen for Part B with each compared to Placebo. Only 4 arms are actually being studied.
15857575|NCT03981822|Combination Product|Placebo|The placebo single-use applicator contains the same formulation as the VP-102 applicator but does not contain the active pharmaceutical ingredient cantharidin
15857576|NCT03981809|Diagnostic Test|"Diagnostic test (PainsCan) for the identification of the dominant pain mechanisms in cancer survivers with persistent pain"|Easy-to-use screening tool to identify the dominant pain mechanism by using quick clinical tests and compare their accuracy and validity with complicated reference tests.
15857577|NCT03981796|Biological|Dostarlimab|Participants will be administered dostarlimab
15857578|NCT03981796|Drug|Placebo|Participants will be administered placebo
15857579|NCT03981796|Drug|Carboplatin|Participants will be administered carboplatin
15857580|NCT03981796|Drug|Paclitaxel|Participants will be administered paclitaxel
15857581|NCT03981796|Drug|Niraparib|Participants will be administered niraparib
15857582|NCT03981783|Behavioral|Best available care (BAC)|Eligible patients are assigned to a standard pulmonary rehabilitation program
15857583|NCT03981783|Behavioral|Telerehabilitation (TH)|Eligible patients are assigned to a pulmonary telerehabilitation program
15857584|NCT03981770|Drug|General anesthesia|For maintenance of propofol anesthesia, total intravenous anesthesia was administered by using propofol (Fresenius Kabi, Austria GmbH) at a plasma target concentration (Marsh pharmacokinetic model software) of 2.5-4 μg/ml. Remifentanil (0.2-0.5 μg/kg/min) was given to all patients during the operation.
15857585|NCT03981757|Device|NeurOS|NeurOS system pads will be placed on patients' head for monitoring.
15857590|NCT03981731|Other|Cardiac coherence|"An initiation session to cardiac coherence will take place between D-10 and D-7 before the operation (during the anaesthesia consultation) in order to obtain a breathing rate of 6 cycles/min via a free application (Respirelax) with listening to an audio tape.
~3 cardiac coherence sessions per day of 5 min (before meals) during the 7 days preceding the operation.
~- The anaesthetic induction will be done with a session of cardiac coherence associated with listening to the audio tape."
15857591|NCT03981718|Procedure|Fat grafting|Lipoaspirates will be collected from the own subjects abdominal fat tissue, during the 2nd stage breast reconstruction and will be injected on each affected breast during the insertion of the permanent breast implant in the 2nd stage of breast reconstruction
15857592|NCT03981705|Radiation|Standard Trimodality Breast Imaging|Standard breast imaging with or without core needle biopsy after neoadjuvant chemotherapy (NAC).
15857593|NCT03981692|Other|Consecutive dual task|8 weeks and 2 days per week, one session 45 min. Consecutive dual task creates the idea that it may provide more workable work without creating stress while doing secondary task during dual task.
15857594|NCT03981692|Other|Integrated dual task|8 weeks and 2 days per week, one session 45 min. Integrated dual task is a proven mode of work that has positive effects on geriatrics
15857595|NCT03981679|Other|Biological collection|The biological collection will also include samples of blood samples collected before colonoscopy
15857596|NCT03981666|Other|Questionnaires|"To patients who have given their consent for the self-screening, the research assistant will propose 3 questionnaires, which will be completed in the waiting room and returned the same day:
~Ad hoc questionnaire for demographics and medical data;
~Insomnia Severity Index (ISI, 7 items, Savard et al., 2005);
~Edmonton Symptom Assessment System (ESAS, 10 items, Visual Analogue Scale, Bruera et al. 1991) assessing comorbidities as pain, dyspnea, anxiety or depression...
~The ISI scoring will be realized by the research assistant (in the research office) immediately after its completion."
15857623|NCT03981445|Behavioral|Adherence Counseling|Counseling for PrEP initiation and adherence and, if necessary, HCV treatment will be provided by the clinical counseling staff of the on-site integrated care arm. Adherence counseling will include, but not be limited to, the indications, advantages, and disadvantages (e.g. side effects) of PrEP and HCV treatment in order to help the participant with his/her decision. The counselor will provide any necessary information to the participants and help them to address health and social needs. If required, the counselor will help the patient and physician with insurance-related issues. Adherence counselling will be carried out in a motivational style. The intervention will include five 30-45 minute face-to-face meetings with the participant and the adherence counselor over 6 months.
15857597|NCT03981640|Other|Acute exercise|Participants will lie in a supine position with their feet attached to the pedals of a custom-arranged cycle ergometer. Participants' 40% heart rate reserve will be calculated, giving the target value to achieve during exercise based on appropriate resistance applied on the cycle ergometer, corresponding to a mild-to-moderate exercise intensity. After a 5-minute resting baseline, participants will perform dynamic cycling exercise for up to 20 minutes. They will then stop exercising, and there will be a 5-minute recovery period. Beat-to-beat renal blood flow velocity (Doppler ultrasound), mean arterial blood pressure (finger photoplethysmographic cuff), and heart rate (electrocardiogram) will be recorded throughout. A rating of perceived exertion will be taken from participants during the last 30 seconds of steady-state cycling exercise.
15857598|NCT03981640|Other|Cold pressor test|Participants will lie in a supine position, and after a 3-minute resting baseline, participants will have their hand immersed in ice water for 2 minutes. This cold pressor test represents the non-exercise, physical sympathetic stressor. Participants' hand will then be removed from the ice water, followed by a 3-minute recovery period. Beat-to-beat renal blood flow velocity (Doppler ultrasound), mean arterial blood pressure (finger photoplethysmographic cuff), and heart rate (electrocardiogram) will be recorded throughout. Ratings of hand pain and cold perception will be taken from participants during the last 30 seconds of the cold pressor test.
15857599|NCT03981640|Other|Mental stress test|Participants will lie in a supine position, and after a 3-minute resting baseline, participants will perform a mental arithmetic task for 5 minutes. This mental stress test represents the non-exercise, psychological sympathetic stressor. Participants will be instructed to subtract a given number from a randomly selected three-digit number and verbally state their answer and continue to do so for the duration of the test. Participants will then stop the arithmetic task, and a 3-minute recovery period will follow. Beat-to-beat renal blood flow velocity (Doppler ultrasound), mean arterial blood pressure (finger photoplethysmographic cuff), and heart rate (electrocardiogram) will be recorded throughout. A rating of perceived stress will be taken from participants during the last 30 seconds of the mental stress test.
15857600|NCT03981627|Drug|ADO09 formulation|Subcutaneous injection of ADO09 formulation
15857601|NCT03981627|Drug|NovoRapid®|Subcutaneous injection of insulin aspart
15857602|NCT03981614|Drug|Binimetinib|Given PO
15857603|NCT03981614|Drug|Palbociclib|Given PO
15857604|NCT03981614|Drug|Trifluridine and Tipiracil Hydrochloride|Given PO
15857605|NCT03981601|Drug|Lovastatin 40 MG|after tooth extraction, put teh lovastatin40 mg wif bone graft wifin tooth socket
15857606|NCT03981601|Procedure|without drug with Bone graft|after tooth extraction, put teh bone graft wifin tooth socket
15857607|NCT03981588|Other|Imaging studies|Patients will undergo different imaging and clinical follow-up procedures to run out cardiotoxicity
15857608|NCT03981562|Drug|Vit D|Patients will take an oral vitamin D supplement once a day for 6 months.
15857609|NCT03981562|Drug|Placebo Oral Tablet|Patients will take a placebo oral tablet once a day for 6 months.
15857610|NCT03981549|Biological|Autologous Bone Marrow CD34+ Stem Cells|Single intravitreal injection of autologous bone marrow CD34+ stem cells. The number of cells to be injected per eye will range from 800,000 to 10 million, depending on the yield of the bone marrow aspiration and the isolation procedure.
15857611|NCT03981549|Biological|Sham Therapy|Sham bone marrow aspiration procedure that penetrates the skin, but does penetrate the bone followed by sham intravitreal injection without penetration of the eye
15857612|NCT03981536|Drug|AP-101|Administered by intravenous infusion (IV)
15857613|NCT03981523|Drug|Benznidazole|50 mg and 100 mg tablet taken orally
15857614|NCT03981523|Drug|Nifurtimox|120 mg tablet taken orally
15857615|NCT03981510|Diagnostic Test|3D-Transit|3D transit investigation consists of a small electromagnetic pill and a detector located in a belt around the waist. The pill is swallowed by the participant and the belt is worn until the pill has left the gastrointestinal tract. The method is without any pain and discomfort for the child. The child will visit the hospital the first time to ingest the capsule alongside a standardized meal, and is then free to go home and proceed with daily activities (beside hard exersize) while wearing the belt with the detector. The next day, the child will again visit the hospital to check whether or not the capsule has left the tract - this is done with a computer and software. The children ingesting two capsules will do this with a certain delay.
15857616|NCT03981497|Procedure|Microwave ablation (MWA)|Thermal ablation
15857617|NCT03981484|Biological|Prothrombin Complex Concentrate|single dose of 25 IU/kg of 4-PCC at time of enrollment
15857618|NCT03981484|Biological|Whole Blood, Plasma, Packed Red Blood Cells|site's standard resuscitation protocol
15857619|NCT03981471|Behavioral|Exercise|Elderly people with or without fall history receive exercise to improve balance. Exercise interevention will be given 6 months in 2020. Outcomes (incidence of fall and biological tests) between two arms will be compared.
15857620|NCT03981458|Device|Hyalofemme|Gel made with hyaluronic acid to be applied vaginally to treat atrophic vaginitis.
15857621|NCT03981458|Device|Ialuril|Bladder instillation of hyaluronic acid to treat recurrent UTI.
15857622|NCT03981445|Behavioral|ARTAS Adapted Patient Navigation|Patient navigation will provided by trained patient navigators to participants randomized to the off-site referral to specialized care arm. Patient Navigators will actively coordinate and link participants to available clinics and community resources by scheduling appointments, arranging transportation, and assisting the participant with completing any paperwork that a clinic or service agent may require. The intervention will include up to five, 30-45 minute face-to-face meetings between the patient navigator and participant. These meetings will be tailored around each participant's needs. Additionally, the patient navigator assists the participant in identifying and utilizing informal and formal sources of support to move along the PrEP and/or HCV care continuum.The patient navigator will help the participant inform off-site physicians of the trial and of the availability of PrEP and HCV medication, should the physician and patient decide to initiate one or both treatments.
15857624|NCT03981432|Behavioral|REST-Fixed|condition without exercise / rest condition. The participants will be asked to remain quiet and at rest during the morning and will receive a fixed meal at lunch. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.
15857628|NCT03981419|Other|Placebo|for IV infusion
15857655|NCT03981133|Behavioral|offer a pacifier|offer a pacifier to normal newborn infants the first days of life
15857629|NCT03981406|Behavioral|Palliative Care|The intervention is one visit to the Fairview Clinics and Surgery Center palliative care clinic, with follow up visits as determined by the palliative care team and the patient.
15857630|NCT03981406|Behavioral|Standard of Care|Control group will receive standard of care treatment for IPF.
15857631|NCT03981380|Drug|11C-PIB|Participants will be injected with an intravenous bolus of up to 5-15mCi (370 MBq) (+/-10%) of [11C]PiB (over 5-10 seconds).
15857632|NCT03981341|Drug|Duavive (0.45 estrogens mg and 20 mg bazedoxifene)|Drug given for 3 months in each participant
15857633|NCT03981328|Device|Dexcom G6 Continuous Glucose Monitoring System|Users insert a tiny sensor wire just under their skin using an automatic applicator. The sensor can measure glucose readings in interstitial fluid throughout the day and night.
15857634|NCT03981328|Device|self-monitored blood glucose|Each participant in the control group will be assigned a study blood glucose meter to measure and store their blood glucose values during the study. Therefore, the Contour® Next One system (or a comparable device) will be used. The meter has CE Mark clearance and is commercially available in Europe. Participants will receive an ample supply of meter test materials based on quantities routinely used.
15857635|NCT03981315|Diagnostic Test|Bile test|Analyze bile components related to gall stones synthesis (cholesterol, bile acids, phospholypids, etc.)
15857636|NCT03981315|Diagnostic Test|Blood test|Analyze blood components related to gall stones synthesis (cholesterol, bile acids, phospholypids, etc.)
15857637|NCT03981315|Diagnostic Test|Gall stone study|Study of the extracted gall stones, analyzing their composition, type, etc.
15857638|NCT03981315|Diagnostic Test|Microbiological bile test|Determination of the microbiological composition of the bile
15857639|NCT03981302|Other|Family nursing conversations|"The intervention is based on the concept family systems nursing developed by Wright & Maureen. Family nursing aims to change restricting beliefs and alleviate illness suffering. The Illness Beliefs model and Calgarymodels are essential components. The illness beliefs model illuminates the family's different beliefs about their problems. The Calgary models consist of the Calgary family assessment model and the Calgary intervention model and aim to support change and help the family to find new ways to handle the illness. The use of the components cannot be standardised but must be tailored to match the needs of the specific family. The family nursing conversations in this intervention will last 1,5 hour. Every family will be offered three family nursing conversations with roughly three weeks interval. If the family after three conversations express a need for follow-up, they will be offered the fourth conversation."
15857640|NCT03981276|Other|Clinical rating scale to measure disease severity and progression|A 13-item scale to rate functional impairment occurring in pure forms of spastic paraplegia (SP). Additional symptoms constituting a complicated form of SP are recorded in an inventory.
15857641|NCT03981276|Diagnostic Test|Next-Gen Sequencing (NGS)|Whole Genome Sequencing, Whole Exome Sequencing, Transcriptomics, Proteomics, Metabolomics
15857642|NCT03981263|Device|MEAVANTI prothesis|"The experimental prosthesis is the MEAVANTI prosthesis (custom-made non-adherent prosthesis in silicone) which can be calibrated to 5 grams near the breast that remains after a mastectomy to create a visual symmetry but also a weight symmetry.
~This prosthesis takes into account the curve of the breasts and the morphological details such as: skin color of the patients, size of the nipples, height of the nipples, shape of the breast.
~The measurements of the patients will be taken using a 3D scanner (i.e. a scanner that corresponds to a 3d scanning and acquiring device (images), not irradiating), a scale and a colour chart."
15857643|NCT03981263|Device|Standard prothesis|This prosthesis will be compared with a standard non-adherent prosthesis (class I, silicone and polyurethane film), among the models available in the three ranges of standard prostheses (Amoena, Anita and Thuasne). The brand and model will be left to the patient's choice.
15857644|NCT03981250|Behavioral|12-week home-based resistance exercise programme|Participants will perform 6 exercises (press-ups, squats, squat jumps, plank, upright row and seated row) for one minute, aiming for the maximum number of repetitions. Participants will perform one exercise per day, for 6 days a week, for 12 weeks.
15857645|NCT03981237|Device|Laser-activated irrigation with a pulsed Er:YAG laser|The root canals and the pulp chamber are filled with NaOCl 3%. Per canal, the laser tip is placed above the root canal entrance and activated (frequency 20 Hz, pulse energy 20 mJ and pulse length 50 μs) for 30s. TThe canal is then rinsed with NaOCl using a 27G needle, followed by a second application of laser, identical to the first.
15857646|NCT03981237|Device|Ultrasonically activated irrigation|The root canals and the pulp chamber are filled with NaOCl 3%. An Irrisafe file, driven by an ultrasonic unit according to the manufacturers' instructions, is held at 1-3 mm from WL (precurved if canal is curved) and activated for 30 s. The canal is then rinsed with NaOCl using a 27G needle. This cycle is repeated three times (i.e. 3*20s).
15857647|NCT03981237|Procedure|Orthograde root canal treatment|After rubber dam isolation and field disinfection, the pulp chamber is accessed. The root canal(s) is/are located and shaped using manual and mechanical NiTi instruments in combination with NaOCl (3%) irrigant. The canals are dried using paper points and obturated with gutta percha and epoxy resin sealer. The tooth is sealed with a temporary or permanent filling.
15857648|NCT03981211|Drug|Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet|8 weeks of 3 x co-formulated tablets of glecaprevir (100mg) and pibrentasvir (40mg) once daily or 4 weeks of 1 tablet sofosbuvir 400 mg and a three fixed-dose combination of glecaprevir/pibrentasvir 100/40 mg tablets administered once daily
15857649|NCT03981211|Drug|Sofosbuvir 400 MG + Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet|4 weeks of 1 x sofosbuvir (400mg) tablet and 3 x co-formulated tablets of glecaprevir (100mg) and pibrentasvir (40mg) once daily
15857650|NCT03981198|Device|Soliton Rapid Acoustic Pulse (RAP)|Treatment of legs and/or buttocks for the temporary improvement in the appearance of cellulite.
15857651|NCT03981185|Device|Accelerated theta burst treatment|"All participants will receive iTBS (intermittent theta burst stimulation) to the left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 80% of resting motor threshold adjust to the skull to cortical surface distance.
~Stimulation will be delivered to L-DLPFC using the MagPRo stimulator."
15857652|NCT03981172|Behavioral|Daily snack food intake|participants consumed 60 gram portions of either low energy density or high energy density snack foods every day for two weeks.
15857653|NCT03981159|Other|Physical training|Physical training for three months, twice per week (60 minutes per session).
15857654|NCT03981146|Drug|Nivolumab|60 Minute IV Infusion
15857657|NCT03981120|Procedure|Laser and Traditional Acupuncture|Acupuncture (traditional and laser) and photobiomodulation will be performed by a certified acupuncturist on-site with experience in reproductive health and the initial visit will include an assessment and traditional Chinese medicine (TCM) diagnosis.
15857658|NCT03981107|Other|Chest Compression Only CPR (CO-CPR) performed by trained bystanders after instructions from dispatchers|"Instructions by dispatcher to bystander to provide CPR with chest-compressions only
~The instructions from the dispatcher in interventional arm include:
~An ambulance is dispatched and is on it´s way to you
~Do CPR with chest compressions only
~Push hard on the chest with a pace of 100/minute without interruptions for rescue breathing."
15857659|NCT03981107|Other|Standard CPR (S-CPR) performed by trained bystanders after instructions from dispatchers|"Instructions by dispatcher to bystander to provide CPR with chest-compressions and rescue breaths in a ration of 30:2
~The Instructions from the dispatcher in the control arm include:
~An ambulance is dispatched and is on it´s way to you
~Do CPR with chest compressions and rescue breathing
~Push hard on the chest 30 times and give 2 rescue breaths. The pace of the compressions should be 100/minute."
15857660|NCT03981094|Drug|BMS-986278|suspension
15857661|NCT03981094|Drug|Pirfenidone|capsule
15857662|NCT03981081|Drug|Prednisone|Corticosteroid treatment is taken in the morning in patients with NIV, and through the gastric tube in intubated patients
15857663|NCT03981068|Radiation|Re-irradiation|Cisplatin for all eligible patients, nimorazole for all SCC
15857664|NCT03981055|Device|Active Comparator: Active tDCS and Active TUS|"Device: Transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes.
~Device: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes."
15857665|NCT03981055|Device|Sham Comparator: Sham TDCS and Sham TUS|"Device: SHAM Comparator Device: transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes.
~Device: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes."
15857666|NCT03981055|Other|Physical Therapy|All subjects will enroll in a conventional PT balance and gait focused training program, and will receive PT 3x/week over the two weeks of stimulation for 45 minutes following the stimulation sessions when applicable.
15857667|NCT03981042|Device|Monitoring|"After the anesthetic induction with sufentanil, propofol and atracurium, patients will be ventilated with mask until:
~- Monitoring group: TOF ratio at the corrugator supercilli will be measured every 15 s after injection of atracurium. When TOF ratio reach 0, laryngoscopy with intubation will be performed"
15857668|NCT03981029|Other|4.0mg Folic Acid received through participation in FACT (NCT01355159)|"Participants in this study received either daily high-dose folic acid supplementation during pregnancy OR placebo through their participation in FACT (NCT01355159). Details of the FACT Folic Acid intervention are provided below:
~Folic Acid 1.0 mg x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid"
15857669|NCT03981029|Other|Placebo received through participation in FACT|"Participants in this study received either daily high-dose folic acid supplementation during pregnancy OR placebo through their participation in FACT (NCT01355159). Details of the FACT Folic Acid placebo are provided below:
~Placebo x 4 tablets will be taken daily by oral administration."
15857670|NCT03981016|Other|Biological collection|"blood samples collected at different times : Before surgery and during the post-operative visit and
~frozen tumor samples and / or paraffin samples at the time of surgery and- paraffin around tumor samples at the time of surgery"
15857671|NCT03981003|Diagnostic Test|Blood sample|2 x 4 ml tubes blood to screen for serum Neurofilament Light Chain and GFAP levels
15857672|NCT03980990|Drug|Metformin|Continuation of Metformin
15857673|NCT03980977|Other|skin biopsy|"skin biopsy will be taken under local anesthesia using a patch of lidocaine and prilocaine. In practice, during the skin biopsy, the skin must be cleaned with chlorhexidine or alcohol, to the exclusion of any other antiseptic. The biopsy will preferably be done with a dermatome (or punch, 12 G)."
15857674|NCT03980977|Other|tumor biopsy|an additional tumor sample will be taken during programmed diagnostic procedure.
15857675|NCT03980977|Other|blood sample|blood sample will be taken for biological collection
15857676|NCT03980964|Device|Active NMES|Daily home-based, mobile-app controlled, neuromuscular electrical stimulation (NMES) therapy
15857677|NCT03980951|Procedure|Dural Puncture Epidural Technique|three labor analgesia techniques
15857678|NCT03980951|Procedure|Combined Spinal Epidural without intrathecal opioids|three labor analgesia techniques
15857679|NCT03980951|Procedure|epidural|three labor analgesia techniques
15857680|NCT03980938|Drug|neflamapimod|40 mg neflamapimod capsule
15857681|NCT03980938|Other|Placebo|matching placebo capsule
15857682|NCT03980925|Drug|Nivolumab|"Subjects will receive Nivolumab 360 mg every 3 weeks (Q3W) first day of each cycle plus Carboplatin AUC5 Q3W first day of each cycle plus Etoposide 100 day 1-3 of each cycle up to 6 cycles of combined therapy (Induction Phase).
~At the time of completion of 6 cycles of chemotherapy and nivolumab, participants who have not experienced disease progression will continue to receive nivolumab at a dose of 480 mg as 30 minute infusion every 4 weeks for up to 2 years (24 months) (maintenance phase).
~Cycles are defined by 4 weeks or 28 days."
15857772|NCT03980171|Drug|Obinutuzumab|A flat dose of 1000mg IV will be given every cycle during induction. a cycle is 28 days.During maintenance 1000mg IV will be given every second cycle for upto 2 years.
15857944|NCT03978741|Device|Yōni.Fit Comparator Device|The Yōni.Fit Comparator Device is a silicone pressary.
15857683|NCT03980925|Drug|Carboplatin|"Subjects will receive Nivolumab 360 mg every 3 weeks (Q3W) first day of each cycle plus Carboplatin AUC5 Q3W first day of each cycle plus Etoposide 100 day 1-3 of each cycle up to 6 cycles of combined therapy (Induction Phase).
~At the time of completion of 6 cycles of chemotherapy and nivolumab, participants who have not experienced disease progression will continue to receive nivolumab at a dose of 480 mg as 30 minute infusion every 4 weeks for up to 2 years (24 months) (maintenance phase).
~Cycles are defined by 4 weeks or 28 days."
15857684|NCT03980925|Drug|Etoposide|"Subjects will receive Nivolumab 360 mg every 3 weeks (Q3W) first day of each cycle plus Carboplatin AUC5 Q3W first day of each cycle plus Etoposide 100 day 1-3 of each cycle up to 6 cycles of combined therapy (Induction Phase).
~At the time of completion of 6 cycles of chemotherapy and nivolumab, participants who have not experienced disease progression will continue to receive nivolumab at a dose of 480 mg as 30 minute infusion every 4 weeks for up to 2 years (24 months) (maintenance phase).
~Cycles are defined by 4 weeks or 28 days."
15857685|NCT03980912|Diagnostic Test|LiverFASt|LiverFASt™ is a blood based diagnostic test utilizing a patented algorithm to determine presence and the progression of liver disease. The test is non-invasive, simple, and less expensive than liver biopsy or liver imaging.
15857686|NCT03980873|Behavioral|ESTEEM (Effective Sikills to Empower Effective Men)|"ESTEEM (Effective Skills to Empower Effective Men) is a 10-session intervention based on the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders (Barlow et al., 2010).
~Is an individually-delivered cognitive behavioral treatment with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation abilities; reducing maladaptive cognitive, affective, and behavioral avoidance patterns; and improving motivation and self-efficacy for enacting behavior change"
15857687|NCT03980860|Other|Exercise Type|The implementation of 2 types of exercise programs to reduce body fat
15857688|NCT03980847|Drug|Alendronate 20 mg|The Alendronate 20 mg combined with nanocrystalline hydroxyapatite as a synthetic bone substitute for socket preservation after tooth extraction
15857689|NCT03980847|Procedure|Nanocrystal hydroxyapatite|Postextraction Sockets Preserved With Nanocrystal hydroxyapatite as a synthetic bone substitute alone as a bone graft
15857690|NCT03980834|Behavioral|ParentCorps FUNdamentals|is a series of large-group experiential PD days (in groups of 25-40 participants from across all schools) which takes place in the first summer prior to implementation. Leaders participate in a 2-day FUNdamentals series with leaders from other schools.
15857691|NCT03980834|Behavioral|ParentCorps 101 E-learning|is a self-paced interactive web-based series with 7 modules intended to help facilitators build confidence and mastery of evidence-based practices.
15857692|NCT03980834|Behavioral|Training|group-based series to prepare facilitators (mental health professionals and teachers) to implement Programs with fidelity and to ensure high levels of exposure by parents and students. Mental health professionals are supported to facilitate the Program for Parents (day and after-school versions) with fidelity. Pre-K teachers and assistants are supported to implement the Program for Students in the classroom. In addition, early childhood staff (including Kindergarten teachers as needed) is trained to facilitate the Program for Students during after-school hours in parallel with the Parenting Program. All facilitators receive training on engaging parents to participate
15857693|NCT03980834|Behavioral|Coaching|is one-on-one support provided in-vivo and from a distance (phone, text, email) to help users apply evidence-based practices in daily interactions with students and parents, and to support high levels of implementation fidelity and exposure. All Pre-K teachers and mental health professionals facilitating ParentCorps receive four on-site coaching visits and 10 30-minute calls for the remaining sessions in the first year for each cycle of implementation.
15857694|NCT03980821|Drug|AZD4635|AZD4635 taken orally
15857695|NCT03980808|Behavioral|American Sign Language-Accessible Diabetes Education|Video-based ASL interpreted diabetes educational intervention (ASL-ADE), the content of which will be derived from diabetes health information regarding symptoms and risk factors that are published by the U.S. Centers for Diseases Control and Prevention (CDC) and the National Institute for Health (NIH) National Diabetes Education Program.
15857696|NCT03980808|Behavioral|Control Intervention|Non-health related video approximately the same length as ASL-ADE.
15857697|NCT03980795|Other|Exercise Program|Participants met with an exercise physiologist at their monthly center appointment over a 3-month period (4 meetings). The consultations took place either together or separate from or with the dietitian's consultation (depending on appointment logistics). In addition the Exercise Physiologists telephone called each intervention participant on a weekly basis.
15857698|NCT03980782|Other|Music Therapy|Individualized music therapy developed playlist(s) that will be used based upon the latest Confusion Assessment Method result (hypoactive, hyperactive or no delirium) delivered twice daily.
15857699|NCT03980769|Drug|Thiotepa|Given IV
15857700|NCT03980769|Drug|Treosulfan|Given IV
15857701|NCT03980769|Drug|Fludarabine Phosphate|Given IV
15857702|NCT03980769|Biological|Rabbit Anti-Thymocyte Globulin|Given IV
15857703|NCT03980769|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo HCT via infusion
15857704|NCT03980756|Drug|AD-206 20mg|1 tablet administered before the breakfast during 7 days
15857705|NCT03980756|Drug|Esomeprazole 20mg|1 tablet administered before the breakfast during 7 days
15857706|NCT03980756|Drug|AD-206 40mg|1 tablet administered before the breakfast during 7 days
15857707|NCT03980756|Drug|Esomeprazole 40mg|1 tablet administered before the breakfast during 7 days
15857708|NCT03980743|Behavioral|iOTA text messaging intervention|Over 6 months, participants in the iOTA arm will have monthly in-person visits with a health coach who will work with the participant to set goals for the upcoming month related to healthy eating and activity. The participant will receive daily text message health tips related to their goals, and will be prompted once a week to respond with a text indicating their weight and how they are doing with their goals. Following the 6-month active treatment phase, participants will receive text messages only for another 3 months.
15857773|NCT03980171|Drug|Venetoclax|During dose escalation, the doses for venetoclax can be 400mg daily days 1-10, 800mg daily days 1-10, 400mg daily continuous or 800mg daily continuous. 6 cycles of treatment will be given during induction. Once the recommended phase 2 dose (RP2D) is established that dose will be used in dose expansion. A further 6 cycles of venetoclax will be given during maintenance if required based on response at the end of induction.
15858416|NCT03974932|Device|Luer Lock Applicator|Applicator for instillation.
15857709|NCT03980743|Behavioral|Health Education text messaging intervention|Over 6 months, participants in the Health Ed arm will also have monthly in-person visits with a health coach who will provide education on energy balance and problem-solving. Specific goals will not be set, but the health coach will assist participants in problem-solving any challenges. Participants will receive a weekly automated motivational text message health tip from the study related to what they learned in their health coaching sessions. Following the 6-month active treatment phase, participants will receive text messages only for another 3 months.
15857710|NCT03980730|Drug|Azeliragon|Azeliragon 5 mg capsule administered orally, once daily
15857711|NCT03980730|Drug|Placebo|Matching placebo capsule administered orally, once daily
15857712|NCT03980717|Device|Goldbal Detachable Balloon and delivery microcatheter|Between 28+0/7 - 31+6/7 weeks gestation for severe CDH placement of the detachable balloon. Balloon retrieval will be planned for no later than 36+6/7 weeks at the discretion of the FETO center.
15857713|NCT03980704|Drug|IMPACT|Administration of oral immunostimulating oral supplement
15857714|NCT03980704|Drug|resource protein|Administration of oral high-protein oral supplement
15857715|NCT03980691|Biological|Chidamide with CAR-T or TCR-T cell therapy|HIV-1 specific therapy
15857716|NCT03980678|Dietary Supplement|Mineral Rich Algae|Lithothamnion species is rich in calcium, magnesium (Mg) and 72 other trace elements absorbed from sea-water during the organisms life. Mineral-rich 'fronds' break off from the living organism, fall to the ocean floor and are harvested (AquaminF). The mineral extract in soluble form contains ~13.1% Calcium, ~1.04% Magnesium and measurable levels of 72 other trace minerals. Following or prior to a washout period (crossover intervention), participants will consume the Aquamin Soluble equivalent of 1000mg Calcium in 250 ml of orange flavored water for a 7 day loading period.
15857717|NCT03980678|Dietary Supplement|Orange flavoured water with maltodextrin as the placebo|Following or prior to a washout period (crossover intervention), participants will consume 250 ml of orange flavoured water (containing 20mg of Calcium with maltodextrin) for a 7 day period.
15857718|NCT03980665|Drug|Arsenic Trioxide|a arsenic class of mineral, clinically approved for treating acute promyelocytic leukemia
15857719|NCT03980652|Procedure|Change of gloves and sterile instruments|Change of gloves and use of separate , sterile instruments before closing the abdominal wall
15857720|NCT03980639|Drug|patient treated with DMARD|Case report of cancer overall
15857721|NCT03980626|Behavioral|Walking|The exercise intervention is designed to improve cardiorespiratory fitness, a known correlate of cognition and brain health, and follows the American College of Sports Medicine exercise guidelines for cancer survivors. Participants will engage in small group, moderate-to-vigorous intensity walking sessions three times weekly. Sessions will begin with a warm-up and end with a cool down and be progressive in nature. Volume of exercise will increase across weeks such that participants will progress from 15-20 minutes of walking to 40-45 minutes by week 8, and from 40-55% of their estimated heart rate reserve (HRR) to 65% of their HRR by week 9. All sessions will be led by trained exercise specialists to ensure close monitoring of participant safety. Participants will wear heart rate monitors and be asked to rate their perceived exertion to ensure they are exercising within the prescribed range. Modifications to each participant's exercise prescription will be made as needed.
15857722|NCT03980613|Other|Triage|Emergency telephone calls from cases and controls are replayed and analyzed for symptom descriptions indicating spontaneous subarachnoid haemorrhage.
15857723|NCT03980600|Device|FibDex wound dressing|Treatment of donor sites of 24 patients with the dressing Type 4 (final product i.e. FibDex) until the self-detachment of the wound dressing i.e. epithelialization
15857724|NCT03980600|Device|NFC wound dressing Types 1-3|Treatment of donor sites of 9 patients with the NFC dressing's (proto)Types 1-3 until the self-detachment of the wound dressing i.e. epithelialization
15857725|NCT03980600|Device|Suprathel (comparator)|Treatment of donor sites of 22 patients with Suprathel dressing, which was used as a reference (comparator) product, until the self-detachment of the wound dressing i.e. epithelialization
15857727|NCT03980561|Drug|Varenicline|Active medication
15857728|NCT03980561|Drug|Placebo|Inactive medication
15857729|NCT03980548|Procedure|CABG|Patients undergoing coronary artery bypass graft and patient presented with ACS undergoing PCI
15857730|NCT03980535|Procedure|Magnetic Resonance Imaging|Undergo MRI
15857731|NCT03980535|Procedure|Magnetic Resonance Spectroscopic Imaging|Undergo MRSI
15857732|NCT03980522|Drug|KPL-914|"KPL-914 (rilonacept) will be provided in its commercially available formulation as a lyophilized powder to be reconstituted for SC administration.
~Adult participants (≥ 18 years of age) KPL-914 will be administered as an initial loading dose of 320 mg SC, delivered as 2 subcutaneous injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks.
~Pediatric participants (6 to <18 years of age) KPL-914 will be administered with an initial loading dose of 4.4 mg/kg, up to a maximum of 320 mg, delivered as 2 subcutaneous injections of 2.2 mg/kg each with a maximum single-injection volume of 2 mL.
~Participants considered to be 'treatment responders' will be offered participation in an optional 18-week extension period (EP) in which KPL-914 can be continued for a total duration of KPL-914 treatment of up to 24 weeks."
15857733|NCT03980509|Drug|Curcumin|Curcumin is an extract from turmeric
15857734|NCT03980496|Drug|Omeprazole|
15857735|NCT03980483|Biological|GSK3196165 (Otilimab)|GSK3196165 solution in vial/pre-filled syringe (PFS) to be administered SC.
15857736|NCT03980483|Drug|Tofacitinib 5 mg|Tofacitinib cap (over encapsulated 5mg tablet) to be administered orally.
15857737|NCT03980483|Drug|Placebo to GSK3196165|Placebo sterile 0.9 percentage (%) weight by volume (w/v) sodium chloride solution in vial/pre-filled syringe (PFS) to be administered SC.
15857738|NCT03980483|Drug|Placebo to tofacitinib|Placebo cap (containing lactose) to be administered orally.
15857739|NCT03980483|Drug|Methotrexate|Stable oral dose of MTX as SoC.
15857740|NCT03980483|Drug|Folic (or folinic) acid|Folic (or folinic) acid >=5 mg/week.
15857838|NCT03979677|Behavioral|Lifestyle Modifications|Written suggestions on common migraine triggering food/beverages to avoid, restful sleep tips, exercise suggestions, and eating set mealtimes will be provided as the intervention.
15857741|NCT03980470|Device|TrueFidelity|"TrueFidelity (Deep Learning Image Reconstruction, DLIR) software by GE Healthcare.
~The medical device in question is a novel reconstruction algorithm for raw CT data which is based on artificial intelligence approaches, namely deep-learning iterative reconstruction (DLIR). This DLIR algorithm will be installed on the console of the CT Revolution scanning device, which is in routine clinical use for cardiac CT scans at the Department of Nuclear Medicine at the University Hospital Zurich. Purpose of this installation is the assessment of the performance of the DLIR algorithm during a limited time span of six weeks.
~The algorithm will be CE-marked at the time of installation and use (statement by GE Healthcare provided separately). Its intended use is the reconstruction of CT datasets.
~Of note, the novel DLIR algorithm will not substitute any clinical routine procedures currently in use. That is, diagnosis will still be made using the standard reconstruction algorithms."
15857742|NCT03980457|Device|Indego Exoskeleton|Powered generated orthosis
15857743|NCT03980457|Other|Standard Rehabilitation|Standard Rehabilitation
15857744|NCT03980444|Device|Basket of wire|(using a basket of wires3F) the helical type was passed through the four wires of the working channel of the orthoscope and routed to the proximal part of the rock, and the stone was routed to the bowl, then the stone was ducted The gasket was kept, and the probe of the pneumatic crusher also passed through the working channel and proceeded to break it down. Conditions were observed during the stomach as control group. Urethroscopic crushing was performed by a urologist in both groups under similar technical conditions. Findings during and after the completion of crushing include the success, stone retropulsion or parts larger than 3 mm, which requires secondary measures (SWL - ureter stenting, resection ureteroscopy), the duration of stone breakdown and traumatic ureteric complications in both groups it is registered
15857745|NCT03980444|Procedure|control group, no basket|"In each group, ureteroscopy was performed using a standard F9.5 ureteroscope. After reaching the rock in group A (control), the probe of the pneumatic crusher was passed through the working channel of the ureteroscope and began crushing the rock.
~During the crushing process, the minimum flow of water, flattening and the single-shot impact was used to minimize the stone's retropulsion."
15857746|NCT03980431|Diagnostic Test|FBY PET Examination|A single dose of 0.10 mCi/kg FBY will be intravenously injected and PET examination will carry out 30 minutes later.
15857747|NCT03980418|Procedure|DaTSCAN SPECT/CT in VERITON-CT camera|the intervention is based on two recordings in camera VERITON-CT ; the first, in focus striatum mode and the second in brain focus mode
15857748|NCT03980405|Dietary Supplement|Group 1- Control Diet|Oral 5ASA+ Low Residue Diet for 6 weeks and Oral 5ASA+ Free Diet for 6 more weeks
15857749|NCT03980405|Dietary Supplement|Group 2- UCD Diet|Oral 5ASA+ UC Diet for 6 weeks and Oral 5ASA+ UC Diet Stage 2 for 6 more weeks
15857750|NCT03980392|Other|Multidomain intervention program|Multidomain intervention program for physical exercise, cognitive training, nutrition, vascular and metabolic risk controls, and motivation
15857751|NCT03980379|Drug|304 injection|Monoclonal antibodies, 100mg/10ml per injection
15857752|NCT03980379|Drug|rituximab injection|100mg/10ml per injection ，manufactured by Roche
15857753|NCT03980366|Device|Electroconvulsive Therapy (ECT)|Bilateral Electroconvulsive Therapy (ECT) to treat self-injurious behavior in adults with Autism Spectrum Disorder (ASD).
15857754|NCT03980353|Other|Questionnaires|The questionnaires have two parts: a general part and a second part focused on the integration in community of the type 1 diabetes children with specific questions about blood glucose, mealtimes, sporting activities and school trips.
15857755|NCT03980340|Behavioral|Short Nap Intervention|Study participants may be asked to have a 1-2 hour nap in between the breath analysis tests.
15857756|NCT03980340|Behavioral|No Nap Intervention|Study participants may be asked to sit or lay down remaining awake for 1-2 hours in between breath analysis tests.
15857757|NCT03980327|Dietary Supplement|probiotic|Lactobacillus probiotic
15857758|NCT03980327|Dietary Supplement|medium chain triglyceride oil|
15857759|NCT03980314|Drug|Nivolumab|Participants will receive nivolumab.
15857760|NCT03980301|Diagnostic Test|ultrasound|screening of pregnant women with hepatitis c virus received treatment in first trimester for congenital anomalies
15857761|NCT03980288|Drug|CAR-GPC3 T Cells|Pretreatment with fludarabine and cyclophosphamide CAR-GPC3 T Cells infusion
15857762|NCT03980262|Behavioral|Healthy Children, Healthy Families+ (HCHF+)|HCHF+ integrates healthful eating and physical activity with parenting education (parent role modeling and child feeding practices) and was recently shown to improve parent and child nutrition behaviors for participants in the Expanded Food and Nutrition Education (EFNEP) program. OrganWise Guys (OWG) will be used for children in first and second grades (ages 6-8). Choose Health: Food, Fun and Fitness (CHFF), developed by Cornell University, will be used for children in grades three through five (ages 8-10). HCHF+ includes 9 sessions to be delivered weekly.
15857763|NCT03980262|Behavioral|Money Smart|Money Smart is a financial literacy education program developed by the Federal Deposit Insurance Corporation (FDIC). Curricula are available for both adults and children.
15857764|NCT03980249|Drug|Carvedilol|Carvedilol: Start at 6.26 mg PO twice daily for 1-2 weeks and if tolerated, will be increased to 12.5 mg PO twice daily for 6 cycles as tolerated.
15857765|NCT03980236|Device|Livongo-Insulia Study App|Throughout the study, participants will be asked to use the LIvongo-Insulia Study App daily to receive their basal insulin dose recommendation. Participants will need to check their before breakfast blood glucose using their Livongo meter. Then, they will need to open the Livongo-Insulia Study App and accept the uploaded blood glucose(s) from the Livongo meter. Once the appropriate information is received, participants will receive an insulin dose recommendation and should confirm once the dose has been taken. Depending on their blood glucose, participants may also receive coaching messages and coaching support from the Livongo program.
15857766|NCT03980223|Drug|Doxycycline Hyclate Delayed-Release 200 mg|200 mg of doxycycline taken by mouth after condomless sexual contact as post exposure prophylaxis (PEP)
15857767|NCT03980210|Procedure|Hyperbaric oxygen therapy|"FiO2 0.21 - 1 ATA
~FiO2 1 - 1 ATA
~FiO2 1 - 2.5 ATA
~FiO2 0.21 - 2.5 ATA
~FiO2 0.21 - 1 ATA"
15857768|NCT03980197|Other|Active surveillance and preemptive isolation|Active surveillance test and preemptive isolation is performed. If MDRO is isolated in surveillance test, contact precaution is needed.
15857769|NCT03980197|Other|Control|No active surveillance and preemptive isolation. If clinical isolates are positive for MDRGNB, start contact precaution
15857770|NCT03980184|Drug|Guanfacine|Guanfacine 3mg/day Versus Placebo
15857774|NCT03980171|Drug|Lenalidomide|During dose escalation, the doses of lenalidomide can be 15mg for days 1-21 or 20mg for days 1-21. 6 cycles of treatment will be given during induction. During maintenance the dose of lenalidomide will be 10mg continuous for a further 6 cycles if required based on response at the end of induction.
15857775|NCT03980145|Device|G-EO System (Reha Technology AG: Olten, Switzerland)|Electromechanically-assisted gait training addresses many of the limitations of therapist-assisted gait training and can be performed using either exoskeleton or end-effector devices. Exoskeleton devices involve programmable drives or passive elements which physically move the lower limbs, whereas, end-effector approaches involve driven footplates that have trajectories that simulate the stance and swing phases.13,14 The G-EO System (Reha Technology: Olten, Switzerland) is a novel end-effector gait training system that was developed for regaining mobility and independence in stroke survivors. This system involves minimal therapist and patient burden (e.g., quick set-up, single operate usage), there is the unique capacity for practicing walking and stair climbing movements, and the patient can receive real-time visual feedback.
15857776|NCT03980145|Other|Conventional Physical Therapy|Conventional physical therapy (CPT): CPT sessions will involve a 3-5 minute warm-up, stretching, progressive strength training exercises, and gait and balance training. Additional strategies for home exercises, energy conservation, fall prevention, and appropriate assistive devices (i.e., orthotics) will be provided.
15857777|NCT03980132|Drug|Lugols Strong Iodine|5 L.I. drops / 8 hours for 10 days before surgery
15857778|NCT03980119|Other|HITSystem 3.0|The HITSystem 3.0 is a web-based intervention that aims to improve pediatric ART retention and adherence, and viral suppression. The HITSystem 3.0 is accessed online through a computer, using mobile broadband modems that respond to a cellular signal. The primary components include: (1) action alerts to complete time-sensitive interventions; (2) real time communication of HIV PCR results to hospitals to reduce turn-around time; (3) continuous follow-up for timely ART initiation among HIV-infected infants; (4) promotion of retention in EID care via SMS text messaging and/or patient tracing; and (5) an automated and individualized SMS text messaging component to communicate with mothers. The HITSystem has a unique dashboard that proactively monitors time-sensitive interventions along the EID cascade of care, alerting clinics, laboratories and mothers when an intervention has been missed.
15857779|NCT03980106|Other|Reciprocal Inhibition Muscle Energy Technique|In this technique, the subject will be asked to contract antagonist muscles against a moderate resistant force provided by the therapist to inhibit the contraction of the agonist muscle.
15857780|NCT03980106|Other|Post-Isometric Inhibition Muscle Energy Technique|In this technique, the subject will be asked to contract agonist muscles against a moderate resistant force provided by the therapist to inhibit the contraction of the agonist muscle.
15857781|NCT03980093|Behavioral|Education|Online medical education on the benefits of anti-hormonal medication, potential side effects, and how to manage them.
15857782|NCT03980093|Behavioral|Values|An Acceptance and Commitment Therapy (ACT)-based intervention consisting of brief online sessions plus a visual cue-based intervention focused on personal values.
15857783|NCT03980080|Drug|OSE-127|"mAb antagonist to CD127 receptor (or IL-7Rα)
~Group 1-7
~6 escalating dose level groups IV
~SC"
15857784|NCT03980080|Drug|Placebo|Vehicle study drug
15857785|NCT03980080|Drug|OSE-127|"mAb antagonist to CD127 receptor (or IL-7Rα)
~Group 8-9
~2 escalating dose level groups IV"
15857786|NCT03980067|Other|Virtual Reality Game|The virtual reality headset, device, and software, created by Stanford's Childhood Anxiety Reduction through Innovation and Technology (CHARIOT)program/Weightless Studio, LLC will be utilized in this study. Children in the VR intervention group will be allowed to select a distraction-based game to play with active VR content featuring interactive avatars and interactive experiences tailored to the pediatric population that allow players to do things such as control penguins sliding down a mountain while collecting pebbles for points, control puppies running in space to collect treats to the rhythm of music, and control an asteroid miner exploring an asteroid belt and collecting points based on color of asteroids collected. The game will last a minimum of 5 minutes in duration, provided participant tolerance. The participant may play longer if desired prior to receiving procedural sedation and the total length of activity played will be documented.
15857787|NCT03980054|Drug|Pyrotinib|pyrotinib 400 mg, orally once daily for one year
15857788|NCT03980054|Drug|Placebo|placebo 400mg, orally once daily for one year
15857789|NCT03980041|Drug|IPI-549 (eganelisib)|IPI-549 (40mg QD) administered orally in 28-day cycles
15857790|NCT03980041|Drug|Nivolumab|Nivolumab (480mg Q4W) administered intravenously (IV) in 28-day cycles
15857791|NCT03980041|Drug|Placebos|Placebo administered orally in 28-day cycles
15857792|NCT03980015|Other|antibiotic treatment|Patients were treated with: ceftriaxone intravenously 2 g OD for 14 days or doxycycline orally 100 mg bid for 10 to 14 days or cefuroxime axetil orally 500 mg bid for 14 days or amoxicillin orally 500 mg tid for 14 days
15857793|NCT03980002|Drug|FCR and Ibrutinib|"Induction treatment:
~Patients <65 y and without significant comorbidities are given FCR 1or 2 courses (If patients' white blood cell count <10×10^9/L after first course, the second course can be saved). Then, patients takes ibrutinib orally for 3 months alternating with FCR in 2 cylcles.
~FCR： F（Fludarabine）：25mg/m2·d，d1-3； C（Cyclophosphamide）：CTX 250mg /m2·d，d1-3； R（Rituximab）：375mg/m2 d0（first course），500mg/m2 d0（subsequent courses）；
~Ibrutinib:420mg/d"
15857794|NCT03980002|Drug|BR and Ibrutinib|"Induction treatment:
~Patients ≥65y and ≤75 y or <65 y but with comorbidities, are given BR 1or 2 courses (If patients' white blood cell count drop to below10×10^9/Lafter first course, the second course can be saved). Then, patients takes ibrutinib orally for 3 months alternating with BR in 2 cylcles. 1.BR： B（Bendamustine）：90mg/m2·d，d1-2； R（Rituximab）：375mg/m2 d0（first course），500mg/m2 d0（subsequent courses）； 2. Ibrutinib: 420mg/d"
15857795|NCT03980002|Drug|Ibrutinib and Thalidomide|"Maintenance treatment:
~After induction treatment, recommend ( but not mandatory) Ibrutinib or thalidomide monotherapy(according to patients preferrance) for MRD-positive patients.For MRD-negative patients, recommend ( but not mandatory) no maintenance therapy."
15857796|NCT03979989|Drug|Tapentadol IR capsule|Tapentadol IR capsule containing 93 mg tapentadol hydrochloride.
15857797|NCT03979989|Drug|Omeprazole capsule|Omeprazole capsule containing 40 mg omeprazole.
15857798|NCT03979976|Drug|Ramipril|Use of ramipril 10mg/day per 12 weeks. Telephone contact was made in the second and sixth week, to ask about possible side effects and ensure adherence
15857799|NCT03979950|Behavioral|Survey|Solid Organ Transplant patients will be recruited via social media. Co-investigators will reach out to the administrators of various social media networks to share information regarding the study with their networks on our behalf. Potential participants who are interested in participating, can then follow the link to the online survey tool, which includes the participant demographic information (age, ethnicity and highest level of education) and questionnaire. The questionnaire is 30 questions long and takes approximately 15 minutes to complete. This questionnaire will be a single, cross-sectional survey. No personal information will be documented on the questionnaire. All responses will be anonymous. Participants will be recruited for 6 months.
15857800|NCT03979937|Procedure|Arthrocentesis|Arthrocentesis to determine the nature of the effusion (septic or aseptic).
15857801|NCT03979924|Behavioral|Trismus rehabilitation|"The patient will be followed-up by a physiotherapist during all the whole radiotherapy treatment, with short 15-min sessions, twice a week. He/she will be trained to perform regularly and by him/herself the preventive/rehabilitation exercises than the patient will do twice a day until the end of the radiotherapy treatment. The patient will then continue, in an autonomous manner, with his/her rehabilitation.
~In case of trismus occurrence, the physiotherapist will advise the patient to add a passive tool to the active exercises (Jaw Trainer, Therabite, tongue depressors,…) in order to strengthen the stretching."
15857802|NCT03979898|Biological|ASTROSTEM|Intravenous injection of Autologous Adipose derived mesenchymal stem cells. Dose : 15kg below : 0.5x10^7cells/5mL 15kg ~ 25kg : 1x10^8cells/10mL 25kg over : 1.5x10^8cells/15mL
15857803|NCT03979885|Behavioral|Smoking cessation counseling (Quitline)|Quitline offers community-based counseling session with a cessation counselor.
15857804|NCT03979885|Behavioral|Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy)|Participants will be encouraged to speak to their doctors about using highly effective pharmacotherapies for smoking cessation.
15857805|NCT03979885|Behavioral|Financial incentives for smoking cessation|Participants will receive financial incentives for bioconfirmed smoking cessation.
15857806|NCT03979885|Behavioral|Financial incentives for use of evidence-based smoking cessation therapies|Participants will receive financial incentives for the use of evidence-based smoking cessation therapies including Quitline counseling, community-based smoking cessation programs and pharmacotherapies
15857807|NCT03979872|Diagnostic Test|MC1R Genetic Testing|[See arm/group descriptions]
15857808|NCT03979872|Other|Skin Cancer Education|[See arm/group descriptions]
15857809|NCT03979872|Device|UV Photo|[See arm/group descriptions]
15857810|NCT03979859|Drug|WCK 4873|
15857811|NCT03979859|Drug|Placebo Oral Tablet|
15857812|NCT03979846|Other|Best Practice|Receive usual care
15857813|NCT03979846|Other|Computer Application|Use computer-based symptom reporting system
15857814|NCT03979846|Other|Questionnaire Administration|Ancillary studies
15857815|NCT03979846|Other|Quality-of-Life Assessment|Ancillary studies
15857816|NCT03979833|Genetic|Whole exome sequencing|DNA from CNS hemangioblastomas and normal tissue (blood) will be analysed using whole exome sequencing.
15857817|NCT03979820|Drug|BI 1467335|Film-coated tablet
15857818|NCT03979820|Drug|Placebo|Film-coated tablet
15857819|NCT03979820|Drug|Phenelzine sulfate|Film-coated tablet
15857820|NCT03979820|Drug|Tyramine|Capsules
15857821|NCT03979807|Drug|Olodaterol/Tiotropium Bromide|(Stiolto®) delivered via Respimat inhaler
15857822|NCT03979807|Drug|Umeclidinium/ Vilanterol|(Anoro®) delivered via Ellipta Inhaler
15857823|NCT03979794|Behavioral|Behavioral Intervention for Wellness and Engaged Living (Be-WEL)|Behavioral Intervention for Wellness and Engaged Living (Be-WEL) is a 4-session (2 preoperative, 2 postoperative) telephone intervention focused on improving emotional and physical health through relaxation, behavioral activation, increased physical activity, and adherence to medication and wound care.
15857824|NCT03979781|Drug|tailored antiplatelet selection|antiplatelet selection guided by platelet function phenotype and/or key pharmacogene genotypes
15857825|NCT03979781|Drug|standard of care|antiplatelet selection using standard of care
15857826|NCT03979768|Other|Diabetes risk assessment service in Norwegian community pharmacies|Two pharmacists at each pharmacy were trained to perform risk assessments and counselling. During six months, pharmacy customers equal or above 45 years old, wishing to participate contacted the pharmacy staff. Participants completed a validated diabetes risk test and a background questionnaire including a validated instrument for self-rated health.
15857827|NCT03979755|Other|Application of questionnaires|Application of questionnaires described by telephone.
15857832|NCT03979729|Other|Routine Screening Mammogram (3D + 2D)|Subjects that have undergone a routine screening mammogram (3D + 2D) will be interviewed by a member of the research team who will ask a few questions to better understand how the subject made this decision and what things may have influenced her decision between different types of mammograms.
15857833|NCT03979729|Other|Routine Screening Mammogram (2D)|Subjects that have undergone a routine screening mammogram (2D) will be interviewed by a member of the research team who will ask a few questions to better understand how the subject made this decision and what things may have influenced her decision between different types of mammograms.
15857834|NCT03979729|Other|No Screening Mammogram|Subjects will participate in a one-time facilitated focus group.
15857835|NCT03979716|Device|fMRI|fMRI examination
15857836|NCT03979703|Other|12 week yoga class|Intervention is a 12 week yoga class with classes twice a week. Each yoga class will last about 1 hour. Furthermore, focus group interviews will be conducted after the first and last yoga class.
15857837|NCT03979690|Device|NISInspire-C System|The NISInspire-C System is a disposable robotic colonoscopy system that consists of a flexible slender insertion tube designed to ensure non-invasive, reliable and safe colorectal screening. It comprises of two components: NISInspire-C Console, and the NISInspire-C Disposable Colonoscope.
15857889|NCT03979209|Drug|Nasal Mometasone Rinse|Nasal irrigation twice a day (BID) of assigned dose.
15857839|NCT03979664|Device|Activapatch intellidose 2.5 using active Iontophoresis|Iontophoresis is a drug delivery system that uses electromigration and electro-osmosis to move charged molecules. Electromigration is the movement of ions across the skin by an electrical field. Positive ions move away from a cathode (positive charge) and towards an anode (negative charge). Negative ions move away from an anode and towards a cathode. Electro-osmosis is the volume movement of positive ions away from the opposite charge. Since skin is negatively charge, positively charged ions penetrate deep in the tissue from the negatively charged skin. 4 The use of iontophoresis was incorporated into medicine in efforts to increase the penetration of medications and avoid injection procedures. Dexamethasone sodium phosphate 4 mg/mL vial will be used in the study. Using a syringe, 2 cc of dexamethasone will be drawn and poured onto the designated medication site on the iontophoresis patch. Once the medication is poured, the patch will be applied on the skin and turned on.
15857840|NCT03979664|Device|Activapatch intellidose 2.5 using inactive Iontophoresis|Iontophoresis is a drug delivery system that uses electromigration and electro-osmosis to move charged molecules. Electromigration is the movement of ions across the skin by an electrical field. Positive ions move away from a cathode (positive charge) and towards an anode (negative charge). Negative ions move away from an anode and towards a cathode. Electro-osmosis is the volume movement of positive ions away from the opposite charge. Since skin is negatively charge, positively charged ions penetrate deep in the tissue from the negatively charged skin. 4 The use of iontophoresis was incorporated into medicine in efforts to increase the penetration of medications and avoid injection procedures. Inactive medication will be used in the study. Using a syringe, 2 cc of inactive medication will be drawn and poured onto the designated medication site on the iontophoresis patch. Once the medication is poured, the patch will be applied on the skin and turned on.
15857841|NCT03979664|Drug|Dexamethasone|Dexamethasone sodium phosphate 4 mg/mL vial will be used in the study. Using a syringe, 2 cc of dexamethasone will be drawn and poured onto the designated medication site on the iontophoresis patch. Once the medication is poured, the patch will be applied on the skin and turned on.
15857842|NCT03979651|Drug|Trametinib plus hydroxychloroquine in patients with NRAS Melanoma (Dose 1)|"Standard dosing of trametinib at 2 milligrams (mg) by mouth once a day, with an escalation of hydroxychloroquine.
~The escalation of hydroxychloroquine will be decided by a 3+3 design with the goal of estimating the Maximum Tolerated Dose (MTD) of trametinib plus hydroxychloroquine. A cycle of treatment will last 28 days. Patients will be evaluated weekly during the first cycle of treatment.
~• Level -1 = Hydroxychloroquine 400 mg by mouth once a day"
15857843|NCT03979651|Drug|Trametinib plus hydroxychloroquine in patients with NRAS Melanoma (Dose 2)|"Standard dosing of trametinib at 2 milligrams (mg) by mouth once a day, with an escalation of hydroxychloroquine.
~The escalation of hydroxychloroquine will be decided by a 3+3 design with the goal of estimating the Maximum Tolerated Dose (MTD) of trametinib plus hydroxychloroquine. A cycle of treatment will last 28 days. Patients will be evaluated weekly during the first cycle of treatment.
~• Level 1 (starting dose) = Hydroxychloroquine 800 mg by mouth once a day"
15857844|NCT03979651|Drug|Trametinib plus hydroxychloroquine in patients with NRAS Melanoma (Dose 3)|"Standard dosing of trametinib at 2 milligrams (mg) by mouth once a day, with an escalation of hydroxychloroquine.
~The escalation of hydroxychloroquine will be decided by a 3+3 design with the goal of estimating the Maximum Tolerated Dose (MTD) of trametinib plus hydroxychloroquine. A cycle of treatment will last 28 days. Patients will be evaluated weekly during the first cycle of treatment.
~• Level 2 = Hydroxychloroquine 600 mg by mouth two times a day"
15857845|NCT03979638|Drug|BLU-5937|Four escalating doses of BLU-5937 administered BID over the course of the study
15857846|NCT03979638|Drug|Placebo|Matching placebo for BLU-5937
15857847|NCT03979625|Other|Hospitalization for more than 3 days with high clinical suspicion of HIT and positive anti-PF4/heparin antibodies|Patients are classified according to results of functional tests as having either Confirmed or Excluded HIT.
15857848|NCT03979612|Genetic|inclusion of subjects in the GENEPY network|The inclusion of subjects in the GENEPY network follows the genealogical study of a case (index): relatives are identified as potentially at risk. In accordance with the recommendations, but also generally at the wish of the patients (Claes 2003), the index case is then asked to inform its relatives and to propose them to go to an oncogenetic consultation of their choice. If these people reside in the Midi Pyrenees Toulouse oncogenetic consultation is open to them. If following this consultation a mutation is identified or that their genetic risk is considered important, they are proposed to join the GENEPY network for their monitoring.
15857849|NCT03979599|Procedure|ultra-sound guided transversus abdominis plan block|comparing ultrasound guided transversus abdominis plan block using combination of magnisum sulphate and levobupivacaine versus levobupivacaine
15857850|NCT03979599|Drug|magnesium sulphate& levobupivacaine|magnesium sulphate& levobupivacaine
15857851|NCT03979599|Drug|Levobupivacaine|levobupivacaine
15857852|NCT03979586|Other|Laser-assisted hyaluronic acid delivery|The facial skin remodeling corresponds to a request for repair treatment on the stigmas of heliodermia, irregularity of cutaneous texture, dyschromias, loss of radiance of the complexion, fine lines, as well as on the fine scars of the face for example, the finely depressed cicatrices sequellaires acne.
15857853|NCT03979573|Diagnostic Test|Multiparametric MRI|Multiparametric prostate MRI (mp-MRI)
15857854|NCT03979573|Diagnostic Test|Radiomics|Radiomics analyses will consist of image intensity normalization, image coregistration and resampling, radiomic feature extraction, combination with clinical and molecular parameters, feature extraction and machine learning, model testing on validation and test cohorts and comparison to existing clinical risk models.
15857855|NCT03979573|Diagnostic Test|MR-guided Biopsy|MR-guided targeted prostate biopsies as well as systematic TRUS-guided biopsies (at least 12 cores) will be performed on a fusion-guided biopsy system. The biopsy cores can either be obtained transrectal or transperineal.
15857856|NCT03979573|Diagnostic Test|Molecular Markers|Molecular markers will be analyzed on the initial and final targeted and systematic biopsy cores. The molecular panel consists of a methylation-specific PCR and a set of highly selected markers that can be detected by immunohistochemistry. The resulting data will be prospectively recorded to enable a retrospective analysis of the prognostic value.
15857857|NCT03979560|Other|Intervention|Nutritional support in seven sessions spread over three months, combined with an adapted physical activity intervention (APA), also at a frequency of seven sessions spread over three months, or fourteen home sessions.
15857943|NCT03978741|Device|Yōni.Fit Test Device|The Yōni.Fit Test Device is a silicone pressary.
15857858|NCT03979547|Behavioral|Exercise intervention|"Moving Through Cancer: A Guide to Exercise for Cancer Survivors will serve as the framework for an American College of Sports Medicine certified exercise physiologist with additional Cancer Exercise training to teach proper warm up, use of equipment, exercise form, mode of activity, intensity of exercise, flexibility exercises, and cool down."
15857859|NCT03979534|Other|low protein diet|Patients will be managed with a restricted protein intake (controlled protein diets with a mean target at 0.6 g / kg / day of protein, according to a choice of dietary approaches, adapted to the situation of each patient).
15857860|NCT03979508|Drug|Abemaciclib|Given PO
15857861|NCT03979508|Procedure|Therapeutic Conventional Surgery|Undergo standard of care surgical resection
15857862|NCT03979495|Other|mFOCUS|To evaluate the effectiveness of the system, team and individual components of mFOCUS vs. standard care by conducting a 4-arm cluster randomized controlled trial (RCT) of individuals who are due for follow-up of an abnormal screen.
15857863|NCT03979469|Drug|Ketamine, dexmedetomidine|Patients will receive non-opioid analgesics, such as dexmedetomidine, ketamine perioperatively
15857864|NCT03979469|Drug|fentanyl, remifentanil|Patients will receive opioid analgesics, such as fentanyl and remifentanil perioperatively
15857865|NCT03979456|Drug|Rituximab|After one year in the trial, the patients are split in the two dosing-arms described above. The dose-comparison phase continues four years.
15857866|NCT03979443|Procedure|Discharge on the day of surgery|Patient discharge on the day of the surgery, usually within 6-8 hours after procedure
15857868|NCT03979417|Other|Blood draw and liver resection|The samples are transferred to the research unit for immunological studies.
15857869|NCT03979404|Device|Intermittent Theta Burst Stimulation|The Magstim Rapid2 Magnetic Stimulator (Magstim ®, UK) will be used to administer active TBS.
15857870|NCT03979391|Diagnostic Test|Tear collection and lumbar punction|Tear collection and lumbar punction will be performed in order to detect supernumerary oligoclonal bands
15857871|NCT03979365|Drug|Envarsus XR|Twice daily tacrolimus vs. Envarsus XR
15857872|NCT03979365|Drug|Tacrolimus twice daily|Twice daily tacrolimus vs. Envarsus XR
15857873|NCT03979352|Drug|empagliflozin|Treatment with empagliflozin 25mg orally once a day
15857874|NCT03979352|Device|artificial pancreas|Insulin delivery via a closed loop single-hormone artificial pancreas system.
15857875|NCT03979339|Procedure|Blood sample collection|A total volume of 32 ml of blood will be collected in each subject and separated in 4 10-mL EDTA vacutainer tubes EDTA tubes of 8 mL each.
15857876|NCT03979326|Procedure|Static stretching|Static stretching lasting 3 x 45 seconds will be performed in each of the examined women three times in different phases of the menstrual cycle: follicular, ovulatory and luteal. Before and after the intervention, a series of tests assessing the influence of stretching on biomechanical parameters will be carried out
15857877|NCT03979313|Drug|MEDI8897|Anti-RSV monoclonal antibody with an extended half-life
15857878|NCT03979313|Drug|Placebo|Commercially available 0.9% (w/v) saline
15857879|NCT03979300|Other|Learning process during role play on psychiatric interview|"Methodology: Mixed method study with:
~Quantitative features:
~Self-reported questionnaries :  Learning Effectiveness Inventory Scale  (18)
~Sociodemographical data and others questions
~Qualitative : Grounded Theory
~Video-record of simulation and audio-record and briefing and debriefing, quoted with conversational analysis
~Semi-structured interview of learners and teachers"
15857880|NCT03979287|Other|Interferential Current and Therapeutic Exercise Program|"The Interferential Current Program will be based on a bipolar application using the Sonopuls 692 device (Enraf Nonius, Rotterdam, The Netherlands). The current parameters will be: a) 4000Hz carrier frequency; and b) 60 Hz AMF with a modulation frequency of 90 Hz. The intensity of the current will be adapted to the sensitivity of each patient.
~The Therapeutic Exercise Program will be applied by a physiotherapist and will consist of:
~Ergonomic advices on reducing repetitive movements and/or maintained positions
~A protocol of active physiotherapy for neck and shoulder muscles. This protocol will include: active stretching exercises; isometric muscle strengthening exercises; reeducation of the ocular and neck muscles with control retraining exercises"
15857881|NCT03979287|Other|Therapeutic Exercise Program|"The Therapeutic Exercise Program will be applied by a physiotherapist and will consist of:
~Ergonomic advices on reducing repetitive movements and/or maintained positions
~A protocol of active physiotherapy for neck and shoulder muscles. This protocol will include: active stretching exercises; isometric muscle strengthening exercises; reeducation of the ocular and neck muscles with control retraining exercises"
15857882|NCT03979274|Drug|Reference Eutirox®|Participants received single oral dose of Reference Eutirox® 600 microgram (3 tablets of 200 microgram) either in treatment period 1 or 2.
15857883|NCT03979274|Drug|Test Eutirox®|Participants received single oral dose of Test Eutirox® 600 microgram (3 tablets of 200 microgram) either in treatment 1 or 2.
15857884|NCT03979261|Diagnostic Test|evolution of sex ratio according to age|Histological study of the collected valves to study the differences according to the sex of the inflammatory reaction and the cellular type found.
15857885|NCT03979248|Drug|BMS-986165|Specified dose on specified days.
15857886|NCT03979248|Drug|Rabeprazole|Specified dose on specified days.
15857887|NCT03979235|Diagnostic Test|Motor function assessment|perform motor function assessment by using scales, sEMG, and inertia sensors
15857888|NCT03979222|Device|Extracorporeal Membrane Oxygenation|ECMO provides extracorporeal gas exchange through use of a membrane oxygenator. Blood is drained from a central vein and returned after oxygenation into either the venous or arterial circulation dependent on configuration.
15857890|NCT03979196|Other|Inpatient Management|"Admission for a minimum of three days, administration of betamethasone, and clinical reassessment by obstetrician after three days. After the initial three day admission, further management will be at the discretion of their obstetrician who will continue their care and decide if further admissions are needed.
~Weekly cervical length assessment will be performed until 28 weeks and patient readmission will be decided by their Obstetrician.
~Post-intervention, women in both arms will receive the same standard of care (weekly clinic or inpatient follow-up appointments) and will be followed to delivery. Prior to delivery, participants will complete a patient Quality of Life survey and at delivery, primary and secondary outcomes will be collected."
15857891|NCT03979196|Other|Outpatient Management|"Avoid heavy lifting and core exercise, avoid intercourse, weekly assessment of cervical length by ultrasound and administration of betamethasone. Patients will continue with outpatient management for the remainder of their pregnancy with no admission unless the patient develops contractions, PPROM, bleeding, or the cervix is dilated to ≥1cm.
~Post-intervention, women in both arms will receive the same standard of care (weekly clinic or inpatient follow-up appointments) and will be followed to delivery. Prior to delivery, participants will complete a patient Quality of Life survey and at delivery, primary and secondary outcomes will be collected."
15857892|NCT03979183|Behavioral|Lumbopelvic, stretching, aerobic and relaxation exercises|Intervention program will comprises brisk walks and small choreographies, global and analytical stretching exercises, as well as lumbopelvic stabilization exercises (with intensity and volume progression)
15857893|NCT03979170|Procedure|Lung tumor resection|lung tumor resection
15857894|NCT03979157|Device|Multispectral Optoacoustic Tomography|Non-invasive transcutaneous imaging of subcellular muscle components
15857895|NCT03979144|Behavioral|Observational study|This was an observational study of a medical device, through the usability assessment, for the registration of a self-test for the immunodeficiency virus (HIV) screening.
15857896|NCT03979131|Combination Product|Avelumab addition to perioperative chemotherapy in GC and GEJC|Avelumab addition to perioperative chemotherapy in GC and GEJC. Peri-operatory treatment consisting of four cycles (each cycle is 14 days) of neoadjuvant chemotherapy (docetaxel, oxaliplatin and fluorouracil/leucovorin) plus avelumab previous to surgery. Surgery is recommended to be scheduled 4 to 6 weeks after the last dose. Afterwards (4 to 10 weeks after surgery), four cycles of adjuvant therapy with the same schema, followed by avelumab up to one year. There will be be a follow-up of 5 years.
15857897|NCT03979105|Drug|Ketamine|Drug: Ketamine Side effects associated with ketamine infusion to treat acute pain, were reviewed after 48 hours of exposure and frequency of tachycardia, hypertension, hallucinations, delirium and nightmares were registrated for comparison
15857898|NCT03979092|Behavioral|IP-ACLS|"Three senior consultants and 12 trainers conduct 2-day IP-ACLS training.
~Pre-class activities: preparation First exposure reading on provider manual and lecturer notes about a new knowledge of ACLS to enhance self-directed learning.
~Interactive lecture sessions: 10 topics Interactive lectures (15-20 minutes per topic) introduce a new knowledge, which anchor to their existing knowledge according to ACLS algorithms.
~Simulation sessions: 10 sessions Skill sessions (50 minutes per session) used high-fidelity simulation mannequin in a team approach. Students learn through role-playing with different practical scenarios. Experiential learning is focused on hands-on and collaborative strategies for enhancing a deeper learning.
~Debriefing: feedback and reflection Trainers provide immediate feedback and discussion throughout the scenarios. Debriefing is focused on the positive aspect and areas for improvement."
15857899|NCT03979092|Behavioral|Waitlist|Waitlist group will participate in subsequent IP-ACLS training.
15857900|NCT03979079|Radiation|external beam radiation therapy|
15857901|NCT03979066|Drug|Atezolizumab|840mg IV every 2 weeks for 2 doses prior to surgery and 4 doses after surgery.
15857902|NCT03979066|Drug|PEGPH20|PEGPH20 3ug/kg IV twice weekly for 3 weeks prior to surgery and once weekly for 3 weeks (of 28 day cycle) for two cycles after surgery.
15857903|NCT03979053|Device|Multiparametric MRI Scan|Patients attending the clinic will have a MRI scan added to their standard of care.
15857904|NCT03979040|Behavioral|Group Transdiagnostic Behavior Therapy|TBT was developed to address transdiagnostic avoidance via the use of four different types of exposure techniques (situational/in-vivo, physical/interoceptive, thought/imaginal, and [positive] emotional/behavioral activation). From the transdiagnostic avoidance perspective, the four exposure practices are matched to the type(s) of avoidance experienced by patients based upon their cluster of symptoms/disorders. Per protocol, the first six sessions of TBT are designed to educate on, prepare for, and practice the four different types of exposure techniques. The next five sessions are focused on practicing and refining exposure practices as participants work through their lists of avoided situations/sensation/thoughts. The final session reviews treatment progress and relapse prevention strategies.
15857905|NCT03979040|Behavioral|Group Disorder-Specific Therapy (G-DSTs)|To provide an evidence-based comparison for the G-TBT condition, G-DSTs will be used that are matched to the participant's principal diagnosis. G-DSTs will include groups for the most common principal diagnoses that have VA-approved protocols and training programs, including PTSD (Cognitive Processing Therapy for PTSD) and MDD (CBT-Depression). Each of these G-DSTs have published manuals for administration and have received extensive support in the literature.
15857906|NCT03979027|Dietary Supplement|Breakfast: ready-to-eat-cereal and milk|
15857907|NCT03979014|Biological|Gardasill 9™ vaccine|3 doses of Gardasill 9™ vaccine 0.5 ml administered 3 times at 0, 2 and 6 month
15857908|NCT03979001|Other|complete ophthalmological examination|"collection:
~ophthalmological history and current treatments
~occular tension measurement
~measurement of visual acuity (Snellen chart)
~Axial length measurement
~Photograph of the posterior segment of the eye
~3x3 and 6x6 macular and papillary OCT angiography"
15857909|NCT03978988|Device|Carotid Stenting|emergent carotid stenting will be performed if the patient is randomized in the intervention arm. The order to treat (head first or neck first), and the choice of a previous angioplasty of the extracranial carotid artery lesion will be left to the interventionist discretion.
15857910|NCT03978988|Drug|Procedural Aspirin|After carotid stenting, an intravenous bolus of 250mg of Aspirin will be given at the end of the procedure in case of absence of complication.
15857911|NCT03978988|Drug|Dual dual antiplatelet therapy after 24-hours imaging follow-up|A dual antiplatelet therapy is administered after 24-hours imaging follow-up excluding intracranial hemorrhagic complications (the type and the dose of the dual antiplatelet therapy are left to the discretion of the local practice)
15857912|NCT03978988|Procedure|Intracranial thrombectomy|Intracranial thrombectomy is the endovascular procedure. In the experimental group, thrombectomy will be completed with a extracranial carotid stenting.
15857913|NCT03978975|Behavioral|Food intake|"For all those session, subjects will take a standardized breakfast (570kcal) three hours before experimental session.
~Control session (CON): subject will stand sited without any activity during 40 min.
~Subjects will be submitted to three aquatic cycling exercise session:
~session 27°C :aquatic cycling at 27°C without water jet during 40 min
~session 27°C+ water jets : aquatic cycling at 27 °C with water jets during 40 min
~session 18°C : aquatic cycling at 187°C without water jet during 40 min Every exercise session will be set at 70% of theorical maximal heart rate During each session, oxygen consumption and carbon dioxide production will be analysed with gas analysis system. Appetite and hunger sensation will be measured with a specific scale at different time point of each day of experimental session. Thirty minutes after the end of each experimental session subjects will have a buffet meal for lunch time."
15857914|NCT03978962|Device|Guided Tissue Regeneration|"Covering oral-maxillofacial or a periodontal defects with the Resorbable Collagen Membrane in order to avoid epithelial cell infiltration and to promote periodontal tissues healing.
~Covering alveolar bone defects after tooth-teeth extraction."
15857915|NCT03978949|Drug|Bacillus Licheniformis|Two weeks prior to the start of radiation therapy, the probiotics is administered three times daily until the end of radiation therapy.
15857916|NCT03978949|Drug|Placebo|Two weeks prior to the start of radiation therapy, the placebo is administered three times daily until the end of radiation therapy.
15857917|NCT03978936|Behavioral|Medication Therapy Management (MTM) Video Telehealthcare|"MTM is an individualized approach to optimize medication use for improved patient outcomes and is designed to empower patients to take an active role in managing patients' medications thus, providing a favorable strategy for addressing adherence issues. Five core elements define MTM: complete medication therapy review (CMR), creation of a personal medication list (PML), development of a medication action plan (MAP), intervention and/or referral for drug therapy problems, and documentation and follow-up"
15857918|NCT03978936|Behavioral|Electronic Adherence Self-Management (EAM)|Participants will have a sensor which monitors their adherence to medication use
15857919|NCT03978923|Device|preparation of the implant site with Piezosurgery vs drill|"The surgery was always performed by the same operator (M.M.) to reduce the bias of the study. Loco-regional anesthesia was performed with Mepivacaine hydrochloride with 1:100000 adrenaline.
~For the preparation of implant sites using traditional methods, the drills were used following manufacturer's protocol by the implant system in use (WINSIX®- BioSAF IN s.r.l, Trezzano Rosa, Trezzano Rosa, Milano - Italy).
~For the preparation of sites was used ultrasonic device, (Surgysonic II, Esacrom S.r.l., Imola, Italy). For the final preparation and insertion of implants, 5-6 ultrasound inserts were used in sequence as follows: tip-shape 1st insert (ES012X) and 2nd insert (ES052XG), crown-shape 3rd insert (ES040), 4th insert (ES041), 5 ° insert (ES043) and 6th insert (ES044).
~The implant insertion was performed with a maximum torque of 35 Ncm. Finally, the cap screws were positioned, and the flaps were sutured in Vycril® 3.0."
15857920|NCT03978910|Other|measurements of the accuracy of the reaching movements|Euclidian distance between final position and target
15857921|NCT03978897|Device|Blood flow restriction tourniquet|A blood flow restriction tourniquet, which impedes arterial flow to extremity at 50% of usual flow.
15857922|NCT03978897|Other|Evidence based physical/occupational therapy|Up to date physical/occupational therapy for lateral epicondylitis
15857923|NCT03978884|Drug|Losartan 50Mg Tab|Take 1 tab daily
15857924|NCT03978884|Drug|Losartan/Hydrochlorothiazide 50 Mg-12.5 Mg ORAL TABLET|Take 1 tab daily
15857925|NCT03978884|Drug|Losartan/Hydrochlorothiazide 100 Mg-25 Mg ORAL TABLET|Take 1 tab daily
15857926|NCT03978884|Drug|Amlodipine 5mg|Take 1 tablet daily
15857927|NCT03978871|Behavioral|Growth Mindset|Growth emotion mindset induction
15857928|NCT03978871|Behavioral|Control|Brain education
15857929|NCT03978845|Drug|Lidocaine|Using an ultrasound and a nerve stimulator, the phrenic nerve will be identified and low-dose lidocaine will be administered perineurally.
15857930|NCT03978832|Drug|PERSERIS|PERSERIS is an extended-release SC injectable suspension administered once-monthly
15857931|NCT03978832|Drug|Risperidone|Oral risperidone
15857932|NCT03978819|Device|ANI|"ANI profiles during IPNS (bradycardia/asystole) or excessive analgesia.
~During surgery continuous monitoring of ANI, HR and Remifentanil effect site concentration was done and recorded. Event markers were placed at the onset of bradycardia, asystole and the coincidence of ANI>80 + Remifentanil >6ng/mL). ANI values of 1 min before and 1 min after the event were used for analysis."
15857933|NCT03978806|Behavioral|Active Comparator: peer navigator|The intervention is aimed to provide support with social challenges and adherence. The peer navigator will meet with patients to provide support with social challenges and use motivational interviewing to provide support with adherence.
15857934|NCT03978806|Other|Placebo Comparator: Control Arm (standard of care)|Control patients will have met the same inclusion and exclusion criteria as intervention patients.
15857935|NCT03978793|Device|MyTPill, a digital pill|MyTPill is a digital pill containing an approved medication
15857938|NCT03978767|Drug|Ibuprofen 600 mg|NSAID pain medication to be used in the experimental bundle for postpartum analgesia
15857939|NCT03978767|Drug|Ketorolac|NSAID analgesic to be used in the experimental bundle for postpartum analgesia in patients who underwent cesarean section
15857940|NCT03978767|Drug|Acetaminophen|Analgesic medication to be used in both treatment arms
15857941|NCT03978767|Drug|Oxycodone|Analgesic medication to be used in both treatment arms
15857942|NCT03978754|Diagnostic Test|ICG、CM、VM、BIS、self-report|ways to examine lymphedema
15857945|NCT03978728|Device|Extra-corporeal membrane oxygenation|Cardiovascular shock patients received extra-corporeal membrane oxygenation suppot.
15857946|NCT03978715|Other|No intervention-retrospective study|This is a retrospective study. No intervention
15857947|NCT03978702|Other|Blood sampling|20 mL will be collected at each time point (day-1,day 0, day 1, day 3, day 7, 1 year after pancreatectomy)
15857948|NCT03978689|Drug|CUE-101|CUE-101 is a novel biologic to treat HPV - driven recurrent / metastatic head and neck cancer given as monotherapy in parts A&B and in combination in Parts C&D according to the schedule described in the protocol.
15857949|NCT03978689|Drug|Keytruda|Keytruda is first-line therapy in HPV16 and HLA A*0201-positive recurrent and/or metastatic HNSCC patients given in combination with CUE-101 in Parts C&D according to the schedule described in the protocol.
15857950|NCT03978663|Radiation|Neoadjuvant radiotherapy|Neoadjuvant radiation therapy delivered to a portion of the index tumour for high-risk breast carcinoma for immune priming prior to neoadjuvant radiation
15857951|NCT03978650|Other|Observational|Participants from the Canadian Longitudinal Study on Aging will be evaluated for cognitive status, occurrence of falls, and fall-related injuries.
15857952|NCT03978637|Drug|Itacitinib|Itacitinib administered orally at the specified dose.
15857953|NCT03978624|Drug|Pembrolizumab|200 mg IV on day 1 and day 22
15857954|NCT03978624|Drug|Entinostat|5 mg given orally on day 1, day 8 and day 15
15857955|NCT03978611|Drug|Relatlimab|Participants will receive IV infusion of relatlimab in Part 1 and Part 2
15857956|NCT03978611|Drug|Ipilimumab|Participants will receive IV infusion of ipilimumab in Part 1 and Part 2.
15857957|NCT03978598|Drug|Etonogestrel|Immediate v. Standard insertion.
15857958|NCT03978598|Device|Nexplanon|Implant.
15857959|NCT03978585|Device|high tone external muscle stimulation|Participants receive self-administered home based high tone therapy for 8 weeks for 30 minutes daily after device instruction
15857960|NCT03978585|Device|transcutaneous electrical nerve stimulation (TENS) therapy|Participants receive self-administered home based TENS therapy for 8 weeks for 30 minutes daily after device instruction
15857961|NCT03978572|Behavioral|Resistance Training|Exercise intervention designed to improve muscular strength and power
15857962|NCT03978572|Behavioral|Moderate-Intensity Continuous Cycling|Exercise intervention designed to improve cardiorespiratory fitness and muscular endurance
15857963|NCT03978572|Behavioral|High-Intensity Interval Cycling|Exercise intervention designed to improve cardiorespiratory fitness, muscular endurance, and muscular strength and power
15857964|NCT03978559|Drug|caspofungin|caspofungin 70mg ivdrip the first day, then 50mg ivdrip qd for 21days
15857965|NCT03978559|Drug|TMP/SMZ(trimethoprim/sulfisoxazole)|TMP:15mg/kg/d for 21 days +SMZ:75mg/kg/d for 21days
15857966|NCT03978559|Drug|Methylprednisolone|40mg ivdrip q12h for 5 days , then 40mg ivdrip qd for 5 days , 20mg for 11 days
15857967|NCT03978546|Diagnostic Test|Humphrey Visual Field Test|SITA Standard and 24-2 and 10-2 visual field tests
15857968|NCT03978546|Diagnostic Test|Optical Coherence Tomography (OCT) Scan|Circle and Wide Angle Scans
15857969|NCT03978546|Diagnostic Test|Smart Perimetry - Henson 9000|24+10-2 Smart Supra test
15857970|NCT03978533|Behavioral|Family Support Group|Family Support Groups will be piloted with families in community and clinical sites. Each pair of facilitators will pilot two groups of 6 families each. Each group is 4 sessions lasting 2 hours each. Each of the sessions incorporates didactic talks, family discussion, and separate breakout groups for adolescents and adults. Family Support intervention incorporates cognitive-behavioral theory of PM+ which underlies evidence-based techniques focused on stress management and behavioral activation. Family support intervention also incorporates resilience theory, which explains family protective processes that can ameliorate the negative consequences of hardships and challenges and enable healing and growth in families.
15857971|NCT03978520|Drug|Elsubrutinib|Capsule; Oral
15857972|NCT03978520|Drug|Placebo for Elsubrutinib|Capsule; Oral
15857973|NCT03978520|Drug|Upadacitinib|Tablet; Oral
15857974|NCT03978520|Drug|Placebo for upadacitinib|Tablet; Oral
15857975|NCT03978507|Behavioral|Intelligent cueing|1 month use of an intelligent, wearable device that provides personalized cueing only when FOG is detected
15857976|NCT03978507|Behavioral|Feedback about the number of steps|Feedback about the number of steps is given in the intervention group as well as in the control group during the 1-month intervention-period.
15857977|NCT03978494|Drug|Advagraf®|Advagraf®1 mg and 5 mg prolonged-release hard capsules once daily (reference medicinal product).
15857978|NCT03978494|Drug|Generic tacrolimus|Tacrolimus 1 mg and 5 mg prolonged release hard capsules (Sandoz) once daily (test medicinal product)
15857979|NCT03978481|Combination Product|Helicobacter pylori eradication (combination therapy)|Antibiotic eradication therapy (triple or quadriple regimen)
15857980|NCT03978468|Other|Interagency Collaboration (ICollab)|The intervention has the following components: 1) ICollab Component 1: The Nurse Clinician will review clinic and emergency room (ER) visit notes for clinicians' recommendations and communicate these to the home health nurse (HHN). 2) ICollab Component 2a: The intervention team will meet weekly by phone with HHNs (6 times/ child). The Nurse Clinician will document meeting notes for each child in the ER, communicate this information with the HHN, and share it with the primary care provider (PCP) by routing the note through the ER or faxing the note. 3) ICollab Component 2b: The Nurse Clinician will be available as a resource for the HHN during regular work hours for clinical problem-solving. 4) ICollab Component 2c: the intervention team physician will offer her contact information for clinical problem-solving about the child to the PCP. The Nurse Clinician will communicate with the PCP about the plan developed in the meetings, and changes to plan of care.
15857981|NCT03978468|Other|Usual Care|The primary medical team identifies the need for home health nursing services for Children with Medical Complexity(CMC), and the hospital care coordinators help caregivers choose a home health agency. Hospital-based physicians write home health orders that are communicated to the home health agency. The clinic manager of the home health agency uses these orders to develop the home health plan of care, Centers for Medicare & Medicaid Services(Form CMS-485) and communicates the plan to the agencies' HHNs. PCPs oversee the home health plan of care.
15858417|NCT03974932|Drug|HTX-011|Dual-acting local anesthetic. Dose 2.
15857982|NCT03978455|Behavioral|Learn, Connect, and Quit Mobile Application|The Learn, Connect, and Quit (LCQ) Mobile Application is an application for electronic tablets that can: assess smokers' interest in quitting; answer smokers' questions about smoking, quitting, and available treatments; provide information about treatment options; communicate information about patients' smoking status, concerns, and treatment interest to their provider; and connect patients with treatment options including the Wisconsin Tobacco Quitline (WTQL), and other smoking intervention resources provided by their healthcare system.
15857983|NCT03978442|Behavioral|Smoking Cessation Cognitive Behavioral Therapy (CBT)|12 sessions of cognitive behavioral therapy for smoking cessation, designed to help participants prepare for quitting smoking, make a quit attempt, and stay quit from smoking.
15857984|NCT03978442|Drug|Bupropion|All medically eligible participants will be prescribed bupropion to begin 7 days before the quit date and continued through 12 weeks post-quit. Participants will be scheduled to begin at 150mg/day of bupropion for at least 3 days before titrating up to 300mg/day dose of bupropion.
15857985|NCT03978442|Behavioral|Cognitive Processing Therapy|12 sessions of CPT, which is a well-established trauma-focused psychotherapy for PTSD that has demonstrated efficacy and effectiveness in Veterans.
15857986|NCT03978442|Behavioral|Smoking Abstinence Reinforcement Therapy|Monetary reinforcement for smoking abstinence that is bioverified by breath carbon monoxide and saliva samples.
15857987|NCT03978442|Behavioral|Yoked Contingency Management|Participants in the yoked control will receive the monetary reinforcement of their yoked participant regardless of smoking abstinence or session attendance.
15857988|NCT03978429|Other|Community-based Pre-eclampsia/Eclampsia Detection and Management|Three Community Health Workers (CHWs) per health facility (cluster) will be equipped with android smartphones and blood pressure monitors. The CHWs will visit participant's home once per month until 6 weeks post-partum and complete a Case Report Form for signs and symptoms of pre-eclampsia and blood pressure. CHWs, Antenatal Care Nurses (ANC) at the woman's health facility and study coordinator will receive SMS message if the algorithm on our platform (informed by the Tanzanian Standard Treatment Guidelines (TSTG) deems she is at risk for pre-eclampsia. This message will indicate that the woman needs to be referred to her health facility if: participant has high blood pressure, a significant intrapatient rise in blood pressure or a combination of factors according to an algorithm. Woman's condition will be assessed and ANC will decide on the management, including rest at home with CHW monitoring. Women found to be at risk for pre-eclampsia will be visited twice monthly.
15857989|NCT03978429|Other|Strengthened Referral Network from Community to Referral hospital levels|ANC nurses and CHWs will play complementary roles in performing activities to meet key indicators and facilitate referrals. They will deliver a plan using the Pre-eclampsia application tool on their smart phone and then they can refer the pregnant woman for enrollment for facility care and track them as per key indicators. The key innovation is that the mHealth platform can detect increases in BP within each patient, and this ability to detect is brought down to the community level through CHWs. This will allow for earlier detection of PE as singular BPs. Nurses will receive protocolized instructions and education regarding when to refer a woman to a higher-level facility for further management. The program consists of SMS component delivered to provide information about participant's condition to relevant members of the referral pathway to enhance referrals and facilitate community level follow up.
15857990|NCT03978416|Behavioral|Healthy Weight for Living for Hispanics|"The Healthy Weight for Living (HWL) intervention, previously developed at the Energy Metabolism Laboratory (HNRCA), is broadly informed by the same behavior change theories as other interventions. For example, it also recognizes individual and environmental factors as potential areas to support behavior change for weight regulation, and provides practical tools for facilitating new habits. However, the HWL places greater emphasis on the role of biology in influencing eating behavior, giving a central role to hunger and food cravings as modulators of eating behavior. Therefore, HWL does not emphasize self-monitoring food intake and does not require increasing physical activity for effectiveness. The new intervention also targets autonomous motivation and prioritizes ease of implementation.
~Information from focus groups and sequential pilots will be used to develop a culturally tailored prototype version of Healthy Weight for Living that is acceptable for Hispanic older adults."
15857991|NCT03978403|Drug|M207 3.8 mg (two 1.9 mg Patches in foil pouches)|M207 3.8 mg administered as two 1.9 mg Patches packaged in foil pouches
15857992|NCT03978403|Drug|M207 3.8 mg (two 1.9 mg Patches in cups)|M207 3.8 mg administered as two 1.9 mg Patches packaged in cups
15857993|NCT03978403|Drug|M207 3.8 mg (two 1.9 mg Patches packaged in cups|M207 3.8 mg administered as two 1.9 mg Patches packaged in foil pouches, Treatment A
15857994|NCT03978403|Drug|Zolmitriptan 2.5 mg Nasal Spray [ZOMIG]|Zolmitriptan 2.5 mg/0.1 mL Nasal Spray [ZOMIG]
15857995|NCT03978390|Behavioral|behavioral priming|Priming the children with images of superheroes in order to behave desirably during the dental injection
15857996|NCT03978390|Behavioral|endowment effect|Giving the rewards to children before starting the dental treatment and telling children they can only keep it if they behave desirably during the dental procedure
15857997|NCT03978390|Behavioral|Positive reinforcement|Giving rewards to the children at the end if they cooperate desirably during the treatment
15857998|NCT03978364|Drug|Azacitidine combined HHT|Azacitidine 75mg/m2，iH，qd×7days，HHT，3mg/m2 ivdrip qd×3 days
15857999|NCT03978364|Drug|Azacitidine regimen|Azacitidine 75mg/m2，iH，qd×7days，28 days a cycle
15858000|NCT03978338|Dietary Supplement|brain polypeptide solution|The experimental group will take the brain polypeptide solution 60ml per day which contains nitrogen 90mg, soybean oil ,glycerin and soybean phospholipids in 84days.
15858001|NCT03978338|Other|same package of placebo|The control group was treated with the same package of placebo 60ml per day which contains soybean oil ,glycerin and soybean phospholipids in 84 days.
15858002|NCT03978325|Other|Control|The control group will receive standard pre-operative care. This involves standard pre-operative advice and a moderate intensity preoperative exercise programme.
15858034|NCT03978117|Dietary Supplement|Freeze dried Powder|Freeze dried powder containing gluconasturtiin, which when added to a provided juice, will result in a target dose of up to 40 mg/day of 2-phenethyl isothiocyanate (PEITC). Preparation consumed at breakfast, lunch and dinner 3x daily for 2 weeks.
15858035|NCT03978117|Dietary Supplement|Placebo Preparation|Placebo powder added to a provided juice. Preparation consumed at breakfast, lunch and dinner 3x daily for 2 weeks.
15858111|NCT03977480|Drug|Hemay007|Hemay007 will be orally administered.
15858003|NCT03978325|Other|Exercise - HIIT Intervention|"The HIIT intervention will take the form of a supervised programme, completed for at least two weeks, up to 5 days per week preoperatively. The HIIT intervention will be performed on a cycle ergometer. Exercise sessions will be individually supervised and scheduled at a time of convenience for each participant. Each exercise session will last 40 minutes and will include warm-up, exercise training and cool-down components. Lactate threshold, measured during the baseline CPT, will be used to determine the exercise intensity.
~The training protocol will prescribe 15 second intervals of exercise and passive recovery. The highest resistance reached during the baseline CPET (measured in watts) will be recorded as the peak power output (PPO). During training, participants will undergo a 5-minute warm-up at 50% PPO, followed by up to 30 minutes of HIIT with intervals of 15 seconds at 100% PPO with 15 second recovery periods at 0 watts."
15858004|NCT03978312|Other|Nominal consensus group|Nutrition Health Literacy Measurement Tool adaptation (NLit-UK)
15858005|NCT03978312|Other|electronic tool completion|Nutrition Health Literacy Measurement Tool validation (NLit-UK)
15858006|NCT03978312|Other|Patient Survey|Nutrition information cancer patient experience survey
15858007|NCT03978312|Other|Friends and Family Survey|Nutrition information friend and family of cancer patients experience survey
15858008|NCT03978299|Diagnostic Test|Positive Prostate-Specific Antigen test result|Positive PSA test result as part of opportunistic screening or due to the presence of symptoms suggestive of disease.
15858009|NCT03978286|Drug|Vortioxetine|10 mg per day
15858010|NCT03978286|Drug|Sertraline|75 mg per day
15858011|NCT03978273|Device|Night-time brace + virtual-brace|"Patients will receive conventional treatment : wearing a night-time brace every night during 6 months.
~Additionally :
~They will perform 5 sessions of postural rehabilitation exercises per week (each of 30 minutes) with the virtual-brace (MD).
~They will have also follow up consultations with a physiotherapist every 21 days, to evaluate treatment observance and to adapt postural exercises according to the results and difficulties encountered.
~Conventional 3D motion capture Analysis (different trunk tasks and walk) will be performed to evaluate evolution of postural parameters at D0, D90 and D180."
15858012|NCT03978273|Other|Night-time brace only|"Patients will receive conventional treatment : wearing a night-time brace every night during 6 months.
~Conventional 3D motion capture Analysis (different trunk tasks and walk) will be performed to evaluate evolution of postural parameters at D0, D90 and D180."
15858013|NCT03978247|Diagnostic Test|NASHMIR|An additional blood sample will be taken upstream of the surgical procedure and a liver biopsy will be performed in all included patients. The two results obtained by the spectroscopic test and by means of the biopsy will then be compared to determine the diagnostic performance of the developped test (NASHMIR test).
15858014|NCT03978234|Drug|AbobotulinumtoxinA 300 UNT|AbobotulinumtoxinA 300 UNT
15858015|NCT03978221|Other|Post-extubation TDI|A diaphragmatic tissue Doppler evaluation will be performed during non-invasive ventilation and spontaneous breathing trial applied in random sequence. Each trial will last 20 minutes. During the last minute of each trial a tissue doppler diaphragmatic examination will be performed to assess the speed of diaphragmatic displacement during inspiration and expiration.
15858016|NCT03978208|Drug|ATB-346 low dose|Double blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients
15858017|NCT03978208|Other|Placebo|Double blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients
15858018|NCT03978208|Drug|ATB-346 mid-dose|Double blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients
15858019|NCT03978208|Drug|ATB-346 standard dose|Double blind comparison of orally administered ATB-346 versus placebo in osteoarthritis patients
15858020|NCT03978195|Device|Non-invasive device for middle ear ventilation|Daily use of the device
15858021|NCT03978182|Device|accelerated deep rTMS|A Magstim Rapid2 Plus1 Magnetic Stimulator connected to the Brainsway dTMS system with the H1-coil investigational device (Brainsway Ltd, Jerusalem, Israel). The coil is situated inside a helmet to achieve effective cooling during stimulation. A sham coil is also included in the same helmet. The sham coil mimics scalp sensations and the acoustic artifact of the active stimulation without inducing neuronal activation.
15858022|NCT03978169|Diagnostic Test|pleuropulmonary ultrasound|three pleuro-pulmonary ultrasound scans will be performed, preoperatively on the day of surgery, post-operatively in the recovery room and the day after surgery
15858023|NCT03978156|Drug|Dronabinol 2.5 MG|Subjects will take dronabinol daily during 2 week dosing period separated by a one week washout period.
15858024|NCT03978156|Drug|Microcrystalline cellulose|Subjects will take placebo daily during 2 week dosing period separated by a one week washout period.
15858025|NCT03978143|Drug|Treatment A|Single 250 mg crizotinib dose as coated microsphere 1 (cMS1) formulation will be administered on the morning of Day 1 after an overnight fast of at least 10 hours.
15858026|NCT03978143|Drug|Treatment B|A single 250 mg crizotinib dose as coated microsphere 2 (cMS2) formulation will be administered on the morning of Day 1 after overnight fast of at least 10 hours.
15858027|NCT03978143|Drug|Treatment C|A single 250 mg crizotinib dose as FC formulation will be administered on the morning of Day 1 after an overnight fast of at least 10 hours.
15858028|NCT03978143|Drug|Treatment D|A single 250 mg crizotinib dose as OS will be administered on the morning of Day 1 after an overnight fast of at least 10 hours.
15858029|NCT03978143|Drug|Treatment E|250 mg crizotinib as cMS1 formulation will be administered with high-fat, high-calorie meal after an overnight fast of at least 10 hours.
15858030|NCT03978143|Drug|Treatment F|250 mg crizotinib as cMS2 will be administered with a high-fat, high-calorie meal after an overnight fast of at least 10 hours.
15858031|NCT03978143|Drug|Treatment G|"40 mg esomeprazole will be administered
~1 hour prior to dinner on Day -5 through Day -1. A single 250 mg crizotinib dose as cMS1 formulation will be administered on the morning of Day 1 after an overnight fast of at least 10 hours."
15858032|NCT03978143|Drug|Treatment H|"40 mg esomeprazole will be administered
~1 hour prior to dinner on Day -5 through Day -1. A single 250 mg crizotinib dose as cMS2 formulation will be administered on the morning of Day 1 after an overnight fast of at least 10 hours."
15858033|NCT03978130|Other|mHealth-CR|Study participants randomized to the intervention (mHealth-CR) arm during the (in-hospital) baseline visit will receive 3 components for their home activity: (1) communication with exercise therapist (in-hospital assessment/counseling followed by regular communication post-discharge), (2) mHealth-CR software, and (3) wearable activity monitoring device.
15858039|NCT03978091|Drug|AZACTAM|A synthetic monobactam antibiotic originally isolated from Chromobacterium violaceum
15858040|NCT03978091|Drug|Ceftazidime-Avibactam|An antibacterial combination product containing ceftazidime and avibactam
15858041|NCT03978078|Other|Biological collection|- Blood samples collected at different times : Before treatment, during treatment (approximately every other month) through the end of treatment
15858042|NCT03978065|Diagnostic Test|Confocal microscopy|"For this purpose live stains will be combined with a confocal imaging setup equipped with 6 laser lines. A major advantage of this technique is that tissue specimens do not need to be fixed prior to analysis. Such an approach does not only allow tissue viability and integrity assessment in an unprecedented speed and accuracy, but also promises to shed new light into quality assessment and prognosis in kidney transplantation. The investigators herein wish to establish the predictive values of this technology in kidney transplantation.
~The methodology used in this trial is referred to as BIOPSYCHRONOLOGY - as a reference to dendrochronology, or tree ring dating. Leaving the biopsy sample intact facilitates its analysis, just as drills are used for tree-ring counting."
15858043|NCT03978052|Dietary Supplement|EGCG|"Participants that weight >50kg intake one oral dose in the morning for breakfast and a second dose in the afternoon in (266 + 266 mg/EGCG, 49 + 49 g of Font-up).
~Participants that weight <50kg intake one oral dose in the morning for breakfast (266 mg/EGCG, 49 of Font-up"
15858044|NCT03978052|Dietary Supplement|Placebo EGCG|Participants that weight >50kg intake one oral dose in the morning for breakfast and a second dose in the afternoon in (266 + 266 mg/EGCG, 49 + 49 g of Font-up)
15858045|NCT03978052|Other|Personalized intervention|A personalized intervention include a physical activity plan,dietary intervention, mental health promotion interventions,
15858046|NCT03978052|Other|Lifestyle recommendations|The recommendations are to balance caloric intake and physical activity to achieve and maintain a healthy body weight; consume a diet rich in vegetables and fruits;
15858047|NCT03978039|Drug|Chemotherapy|treatment as per standard of care
15858048|NCT03978039|Drug|Immunotherapeutic Agent|treatment as per standard of care
15858049|NCT03978039|Drug|target treatment|treatment as per standard of care
15858050|NCT03978039|Procedure|Surgery|treatment as per standard of care
15858051|NCT03978039|Radiation|Radiotherapy|treatment as per standard of care
15858052|NCT03978026|Behavioral|Nap|Each participant is compared to himself in 4 conditions,
15858053|NCT03978013|Other|Pomegranate juice|Pomegranate juice
15858054|NCT03978013|Other|Apple juice|Apple juice
15858055|NCT03978000|Drug|IBP-9414|Oral suspension
15858056|NCT03978000|Drug|Placebo|Sterile water
15858057|NCT03977987|Drug|nucleos(t)ide analogue|Pregnant women in this group agree to receive nucleos(t)ide analogue (tenofovir or telbivudine) daily from the 28 weeks of pregnancy to delivery.
15858058|NCT03977974|Drug|LY3526318|Administered orally
15858059|NCT03977974|Drug|Placebo|Administered orally
15858060|NCT03977948|Other|semi-structured systemic interview|Semi-structured systemic interviews will be conducted with families who have benefited from the preparation for surgery through play. Other tools such as the logbook and the socio-demographic questionnaire will also be used. The themes that will emerge from these interviews will provide a better understanding of what these families are going through, how the proposed intervention may or may not have met their expectations, and provide insights so that health care services can build their own surgical preparation programs.
15858061|NCT03977935|Device|the second-generation MCCG|Patients in the experimental group swallowed the second-generation MCCG (Ankon Navicam-2).
15858062|NCT03977922|Other|Diet group|The diet group will be involved in a 12-week pilot nutrition program that will be based on the anti-inflammatory diet previously studied by Allison and Ditor (2015).
15858063|NCT03977896|Procedure|11C-MET PET/MRI|"Except PET/MRI imaging, all the examinations will be done according to the patient's usual care.
~PET/MRI imaging will be realized within max 7 days after children enrollment, and the surgery (usual care) will be performed within max 4 days after PET/MRI imaging.
~PET/MRI imaging will include the following sequences: T1axial, Diffusion, Magnetic susceptibility post-Gadolinium injection, 3DT1 pre and post-Gadolinium injection, and Arterial Spin Labelling Imaging (ASL)."
15858064|NCT03977870|Other|vital status determination|consultation of national registries
15858065|NCT03977844|Other|Technical Assistance|"TA for Individual Programs TA uses experts to train program staff via webinars and site visits, using the same toolkits as CEP, in a train the trainer approach. TA provides a series of webinars and as needed site visits, focused in the example of depression care on team support for assessment, treatment support as appropriate with medication and/or psychotherapy, case management and educational resources and access to intervention toolkits. It also includes webinars and training toolkits for agencies on domains of social risk factors for health (financial security and housing security) as well as disaster preparedness and recovery."
15858066|NCT03977844|Other|Community Engagement and Planning|CEP for Coalitions CEP creates multi-sector networks to collaborate in evidence-based and community-prioritized toolkits or intervention materials. CEP supports a series of biweekly to monthly meetings to develop network and individual program capacity, prepare stakeholders as co-leads, and create a written training plan following CPPR principles [48, 64]. CEP councils consider local context, i.e., cultural assets and stakeholder input. Disaster preparedness and public health sectors will be encouraged to offer education/resources on social determinants and disasters within CEP training plans. CEP will be supported by a Learning Collaborative, meeting 2-3 times, using activities such as project examples, tabletop exercises and self-assessment to identify gaps and formulate goals for improvement.
15858067|NCT03977844|Other|Community Resources (CR)|The CR app will primarily provide informational resources and referral information relevant to the local community. We will identify resources for depression, social determinants and disaster preparedness and response within each community during planning with local stakeholders.
15858112|NCT03977480|Drug|Placebo|Placebo
15858113|NCT03977467|Drug|Atezolizumab|In Arm A, patients with NSCLC will be randomized 1:1 to either chemotherapy plus atezolizumab at a flat dose of 1200 mg IV every 3 weeks or chemotherapy alone until progression or unacceptable toxicity.
15858068|NCT03977844|Other|Community Resources + eBT|"The CR+eCBT app consists of the functionality of the CR app along with an interactive component to support CBT-informed coping with mood and stressors at the individual level. This component was developed previously by our group using participatory methods with community partners and includes interactive support to enhance social support networks, support cognitive restructuring (framed through partnered input as Catch it, Check it, Change it), and encourage pleasant activities [65]. Participants will receive text message notifications (with frequency set by participants, up to several times per day) and can either reply back to messages to explore content or click a link in the message to access the interactive mobile app."
15858069|NCT03977831|Procedure|Radical Cystectomy|Participants are randomly and blinded assigned
15858070|NCT03977805|Drug|Hetrombopag Olamine|a single oral taking
15858071|NCT03977792|Drug|BOR15001L7|BOR15001L7 topically applied to infected area, 5 times a day, until complete healing of the infection.
15858072|NCT03977792|Drug|Docosanol Cream 10%|Comparator product topically applied to infected area, 5 times a day, until complete healing of the infection.
15858073|NCT03977779|Device|Placement of ARCHIMEDES fast biodegradable stent during the Endoscopic Retrograde CholoangioPancreatography|The ARCHIMEDES Fast biodegradable pancreatic stent will be placed during the Endoscopic Retrograde CholoangioPancreatography
15858074|NCT03977766|Procedure|Chemotherapy prevalidation|"Outpatient Chemotherapy prevalidation will done
~with the help of a nurse, using the digital application, for cycle 2 and 3.
~by the patient alone, using the digital application, for cycle 4 and 5."
15858075|NCT03977753|Drug|2LVERU® or 2LVERU® JUNIOR|"The treatment schema consists in taking the content of one capsule a day, 15-30 minutes before breakfast, on an empty stomach, sequentially, according to capsules' numerical order: 1 through 10. When capsule number 10 is taken, capsule 1 of the next blister should be taken on the next day to continue the treatment.
~The duration of treatment will be 6 months of continuous intake of the content of 1 capsule/day."
15858076|NCT03977753|Drug|Placebo|"The treatment schema consists in taking the content of one capsule a day, 15-30 minutes before breakfast, on an empty stomach, sequentially, according to capsules' numerical order: 1 through 10. When capsule number 10 is taken, capsule 1 of the next blister should be taken on the next day to continue the treatment.
~The duration of treatment will be 6 months of continuous intake of the content of 1 capsule/day."
15858077|NCT03977740|Other|chest PNF|Chest PNF technique includes oblique downward pressure at sternum, diagonal pressure at lower rib cage at supine line, caudal medial pressure at side lying, Caudal pressure at ribcage at prone lying, dorsal and caudal pressure at prone on elbow.
15858078|NCT03977740|Other|Conventional|conventional chest physiotherapy treatment, which includes Deep breathing exercise, Diaphragmatic breathing exercise, segmental breathing exercise and purse lip breathing and incentive spirometer
15858079|NCT03977727|Drug|Fiasp®|Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system
15858080|NCT03977727|Drug|Novolog®|Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system
15858081|NCT03977727|Device|670G hybrid closed loop continuous subcutaneous insulin infusion system|CSII
15858082|NCT03977714|Device|Zirconia implants with G3-coated abutments (test implants and abutments)|"Test and control interventions correspond to those usually applied in dental implantology. The two-step protocol will be followed. Local anesthesia will be applied. A flap will be raised to perform a progressive perforation with a gradual increase of the orifice and a profuse irrigation until the bone preparation adapts perfectly to the implant. Implants will wear a closure cap and will be covered within the gingival flap during osseointegration (eight weeks), after which they will be exposed to evaluate secondary stability and to place the abutment, for which local crestal anesthesia will be applied. To expose the closure cap, a tissue punch will generally be used. Once placed, the abutments will not be removed from the implants. All abutments will be covered with a PEEK healing cap during prosthesis fabrication. Finally, the implants will be rehabilitated with fixed prostheses according to the needs of each patient. A follow-up period of 1 year is expected."
15858083|NCT03977714|Device|Zirconia implants with control abutments (test implants, negative control abutments)|"Test and control interventions correspond to those usually applied in dental implantology. The two-step protocol will be followed. Local anesthesia will be applied. A flap will be raised to perform a progressive perforation with a gradual increase of the orifice and a profuse irrigation until the bone preparation adapts perfectly to the implant. Implants will wear a closure cap and will be covered within the gingival flap during osseointegration (eight weeks), after which they will be exposed to evaluate secondary stability and to place the abutment, for which local crestal anesthesia will be applied. To expose the closure cap, a tissue punch will generally be used. Once placed, the abutments will not be removed from the implants. All abutments will be covered with a PEEK healing cap during prosthesis fabrication. Finally, the implants will be rehabilitated with fixed prostheses according to the needs of each patient. A follow-up period of 1 year is expected."
15858084|NCT03977714|Device|Titanium implants with G3-coated abutments (control implants, test abutments)|"Test and control interventions correspond to those usually applied in dental implantology. The two-step protocol will be followed. Local anesthesia will be applied. A flap will be raised to perform a progressive perforation with a gradual increase of the orifice and a profuse irrigation until the bone preparation adapts perfectly to the implant. Implants will wear a closure cap and will be covered within the gingival flap during osseointegration (eight weeks), after which they will be exposed to evaluate secondary stability and to place the abutment, for which local crestal anesthesia will be applied. To expose the closure cap, a tissue punch will generally be used. Once placed, the abutments will not be removed from the implants. All abutments will be covered with a PEEK healing cap during prosthesis fabrication. Finally, the implants will be rehabilitated with fixed prostheses according to the needs of each patient. A follow-up period of 1 year is expected."
15858114|NCT03977467|Other|Chemotherapy (Arm A Only)|Platinum-based standard of care doublet chemotherapy (or triplet if bevacizumab is used) will be given by IV every 3 weeks. Platinum chemotherapy may be cisplatin or carboplatin chosen based on histology and at the discretion of the treating investigator. It should be administered according to the directions in the approved labeling.
15858115|NCT03977454|Procedure|Nerve Block|"Nerve blocks (QLB/LFCNB) to be placed preoperatively with DEX/MPA, per standard of care of anesthesia block service.
~QLB: 40ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA
~LFCNB: 20ml 0.2% ropivacaine with 5 mg DEX/ 40 mg MPA"
15858418|NCT03974919|Other|NO intervention required|NO intervention required
15858085|NCT03977714|Device|Titanium implants with control abutments (negative control implants and abutments)|"Test and control interventions correspond to those usually applied in dental implantology. The two-step protocol will be followed. Local anesthesia will be applied. A flap will be raised to perform a progressive perforation with a gradual increase of the orifice and a profuse irrigation until the bone preparation adapts perfectly to the implant. Implants will wear a closure cap and will be covered within the gingival flap during osseointegration (eight weeks), after which they will be exposed to evaluate secondary stability and to place the abutment, for which local crestal anesthesia will be applied. To expose the closure cap, a tissue punch will generally be used. Once placed, the abutments will not be removed from the implants. All abutments will be covered with a PEEK healing cap during prosthesis fabrication. Finally, the implants will be rehabilitated with fixed prostheses according to the needs of each patient. A follow-up period of 1 year is expected."
15858086|NCT03977714|Device|Zirconia implants and titanium implants, for histological and histomorphometric evaluation.|"6 implants (3 tests and 3 controls) will be used to evaluate and compare osseointegration, via histological and histomorphometrical analysis, in the area of the wisdom teeth (non useful sites that will not interfere with the rest of the study or the patient's life) - it can only be performed in patients who no longer have these teeth. The procedure will match that described for Groups A-B-C-D. In this case, implants will only remain in the mouth for 2 months, after which they will be removed for analysis. The extraction will be performed with local anesthesia. A flap will be raised to expose the implant and, using a trephine bur (1 mm wider than the implant diameter), a bone cylinder containing the implant will be extracted. The resulting bone defect and regeneration process will be similar to those following a normal molar extraction. The flap will be sutured and primary curing is expected. A new implantation will not be carried out since in this area it is totally unnecessary."
15858087|NCT03977701|Behavioral|Phonological treatment|The clinician will provide models, verbal and/or tactile cues, and/or conversational recasts of speech sound targets following the methodology of Gierut and colleagues. Up to 100 productions will be targeted per 1-hour session.
15858088|NCT03977701|Behavioral|Morpheme treatment|The clinician will provide models, verbal and/or tactile cues, and/or conversational recasts of targeted morphemes following the methodology of Plante and colleagues. A minimum of 50 productions will be targeted per 1-hour session.
15858089|NCT03977688|Device|Cytokin Adsorption|Haemadsorption with Cytokin Adsorber (Cytosorb)
15858090|NCT03977675|Drug|Ketamine|Patients are assigned to one of three ketamine doses (0.3, 0.5, or 0.7 mg/kg) that will be administered intravenously.
15858091|NCT03977662|Combination Product|Co-transplantation of PTG with pancreatic islets|Co-transplantation of allogeneic parathyroid glands (PTG) with adult pancreatic islets (both PTG and pancreatic islets obtained from same deceased donor) in people with Type 1 diabetes in the intramuscular (IM) site with stable function of liver or kidney allografts on chronic immunosuppression
15858092|NCT03977649|Drug|erenumab|erenumab 140 mg sc every 4 weeks
15858093|NCT03977649|Drug|placebo|placebo sc every 4 weeks
15858094|NCT03977610|Drug|Ga-68 PSMA ligand|For PSMA PET/CT scan, the subject will have catheter(s) placed for intravenous administration of [68Ga]PSMA-11. Subjects will receive a single intravenous bolus of 2-5 mCi [68Ga]PSMA-11 and received PET/CT scan 60 minutes later. Patient will underwent two times of PSMA-11 PET/CT scans before and under androgen deprivation therapy within a 10-14 weeks interval.
15858095|NCT03977584|Drug|Crenezumab|Crenezumab will be administered subcutaneously (every 2 weeks) or IV (every 4 weeks) for at least 260 weeks.
15858096|NCT03977584|Drug|Placebo|Placebo matched to crenezumab will be administered subcutaneously (every 2 weeks) or IV (every 4 weeks) for at least 260 weeks.
15858097|NCT03977584|Other|[^18F]GTP1|IV [^18F]GTP1 will be administered up to three times. The first primary [^18F]GTP1 tau PET scan will occur during any visit in the main protocol NCT01998841 (GN28352) from Week 130 to Week 224 and the second [^18F]GTP1 tau PET scan from Week 248 to Week 260. The third and optional [^18F]GTP1 tau PET scan will supplement the two primary scans.
15858098|NCT03977571|Procedure|Cytoreductive nephrectomy|Partial or complete nephrectomy by open, laparoscopic, or robotic approach.
15858099|NCT03977571|Drug|Nivolumab|i.v 3mg/kg every 3 weeks for a total of 4 doses, as induction, followed by nivolumab monotherapy, 6 mg/kg or max 480 mg every 4 weeks, as maintenance
15858100|NCT03977571|Drug|Ipilimumab|i.v 1 mg/kg every 3 weeks for a total of 4 doses, as induction
15858101|NCT03977571|Other|Tissue sampling|Tumor biopsies, blood, and stool specimens for translational biomarker research will be sampled at baseline and after 3 or 6 months.
15858102|NCT03977558|Behavioral|Intervention group|Isocaloric diet including ~50g canola oil
15858103|NCT03977558|Behavioral|Control group|ESC/EAS Guidelines for the management of dyslipidemias
15858104|NCT03977545|Diagnostic Test|Actigraphy|Actigraphy will be realized twice a day during 30 minutes and Lipsitz scoring system will be realized at the same moment to analyze the correlation between Lipsitz scoring system and actigraphy in each arm.
15858105|NCT03977532|Other|Micro-blood sampling|capillary sampling of 40 microliters performed at the fingertip
15858106|NCT03977519|Procedure|MA|Huatuo Brand needles (0.30×25mm,0.30×40mm or 0.30×75mm) will be used.Participants will receive manual acupuncture for 30 minutes each time.After acupuncture,we will twist the needles every 10 minutes for about 30 seconds.The patients will be treated in their first day of dysmenorrhea, once a day for three consecutive days. And the treatments will last for three consecutive menstrual cycles.
15858107|NCT03977519|Procedure|TENS|Huatuo Brand electrode patch (50mm×50mm) and the SDZ-V EA apparatus (Suzhou Medical Appliance) will be used.Participants will receive transcutaneous electric nerve stimulation for 30 minutes each time.They will be treated in their first day of dysmenorrhea, once a day for three consecutive days. And the treatments will last for three consecutive menstrual cycles.
15858108|NCT03977506|Diagnostic Test|On-road driving evaluation|"The data assessed during the road test from the two assessment grids (recommendations of the HAS and Test ride for investigation practical fitness to drive) :
~road position, vehicle control, track management, safety distances, speed, visual behavior, traffic signs, vehicle overtaking, anticipatory reactions and capabilities adaptation, attentional skills, decision-making, communication with other road users, assessment of specific situations such as insertion on a 2x2 lane, mechanical management and general impressions."
15858109|NCT03977493|Drug|Xeomin|One injection of 2.5 to 40 U in each muscle. Injection repeated after 6 weeks if considered necessary
15858110|NCT03977493|Drug|Placebo - Concentrate|One injection in each muscle.
15858116|NCT03977454|Procedure|Periarticular Injection (PAI)|"Intraoperatively, the surgeon will perform PAI per standard of care with the medications:
~1. 60 ml 0.2% ropivacaine and 10 mg DEX/ 80 mg MPA"
15858117|NCT03977454|Drug|Ropivacaine|60 ml 0.2% ropivacaine
15858118|NCT03977454|Drug|Dex|10 mg DEX/ 80 mg MPA
15858119|NCT03977441|Drug|Agomelatine or PIacebo|control group:Pramipexole+pIacebo experimental group:Pramipexole+Agomelatine
15858120|NCT03977428|Other|standard of care|No intervention, this a patient registry and is purely an observational study
15858121|NCT03977402|Other|Biological specimen collection|Collection of blood, tissue, other biological samples and their associated data (survey data, medical records data, cancer registry data, and other related data) from patients with cancer or at risk of having cancer. This is not a treatment trial. It is a study designed to create a centralized data and tissue repository.
15858122|NCT03977389|Procedure|Total wrist denervation|Study of the files
15858123|NCT03977376|Other|Guide of hosting|Guide of hosting with information about hospitalization to decrease anxiety
15858124|NCT03977363|Drug|Anticoagulant drugs|Anticoagulant drugs
15858125|NCT03977350|Device|EEG monitoring|EEG monitoring under general anesthesia
15858126|NCT03977337|Procedure|Major emergency abdominal surgery|Major emergency gastrointestinal surgery performed within 72 hours of an acute admission or an acute reoperation.
15858127|NCT03977324|Procedure|Chlorhexidine|Inflammatory tissue, excess cement or plaque deposits will be removed using titanium curettes and the implant surface will be cleaned by copious irrigation with sterile saline and surgical gauze soaked in chlorhexidine.
15858128|NCT03977324|Procedure|Connective Tissue Graft|CTG will be positioned in the buccal aspect of the peri-implant tissue
15858129|NCT03977311|Device|Sonalleve Magnetic Resonance-guided High Intensity Focused Ultrasound (MR-HIFU)|-To be used in conjunction with radiation therapy in the treatment of locally advanced cervical carcinoma patients
15858130|NCT03977311|Radiation|Radiation therapy|-Standard of Care
15858131|NCT03977298|Procedure|Chlorhexidine|Inflammatory tissue, excess cement or plaque deposits will be removed using titanium curettes and the implant surface will be cleaned by copious irrigation with sterile saline and surgical gauze soaked in chlorhexidine
15858132|NCT03977298|Procedure|CTG|CTG will be positioned in the buccal aspect of the peri-implant tissue
15858133|NCT03977285|Procedure|chlorhexidine|Inflammatory tissue, excess cement or plaque deposits will be removed using titanium curettes and the implant surface will be cleaned by copious irrigation with sterile saline and surgical gauze soaked in chlorhexidine.
15858134|NCT03977272|Drug|Combination drug|Accompanying with modified-FOLFIRINOX, Anti-PD-1 antibody was applied biweekly
15858135|NCT03977272|Drug|Chemotherapy|modified-FOLFIRINOX
15858136|NCT03977259|Other|Individually targeted fortification|"Abbott liquid protein and/or medium chain triglyceride are added routinely to ensure that the base milk has protein 1 g/dL and calories 67/dL."
15858137|NCT03977246|Behavioral|Open-placebo|Application of the open-placebo intervention
15858138|NCT03977246|Behavioral|Control|Application of the control session
15858139|NCT03977233|Drug|Oxaliplatin|85 mg/m2 in 250 cc Dextrose solution given by IV on Day 1 of each 14-day cycle
15858140|NCT03977233|Drug|Leucovorin|400 mg/m2 in 100 cc dextrose solution given with irinotecan by IV on Day 1 of each 14-day cycle
15858141|NCT03977233|Drug|Irinotecan Hydrochloride|180 mg/m2 in 500cc dextrose solution given with leucovorin by IV on Day 1 of each 14-day cycle
15858142|NCT03977233|Drug|5-FU|400 mg/m2 bolus and then 2400 mg/m2 via continuous infusion on Day 1 of each 14-day cycle
15858143|NCT03977220|Drug|Nab-paclitaxel combined with S-1|Nab-paclitaxel combined with S-1 treating diffuse type of stage Ⅲ gastric cancer as adjuvant setting
15858144|NCT03977207|Drug|Levothyroxine Sodium|Thyroid hormone supplement
15858145|NCT03977207|Drug|Placebos|Placebo oral capsule
15858146|NCT03977194|Drug|Carboplatin|AUC 6 every 4 weeks
15858147|NCT03977194|Drug|Paclitaxel|90 mg/m² D1, 8, 15, every 4 weeks
15858148|NCT03977194|Drug|Atezolizumab|1200 mg every 3 weeks
15858149|NCT03977181|Behavioral|Group-based Community Health Club|GBHCs will be facilitated by trained Lay Health Counsellors (LHC). GBHCs will consist of a maximum 20 participants. GBHC sessions will held multiple times a month in each study area, allowing for flexibility for study participants. Sessions will be held at a safe and secure, centrally located area within the study community, and will be regularly monitored and assessed by the study coordinator. Participants will be invited to join a club-specific WhatsApp group to facilitate group communication and adherence support throughout the month. They will also be invited to partner up with another participant to provide mutual peer support. Permission will be sought from group-based adherence support participants before they are added to WhatsApp groups. Group adherence counsellors assigned will be members of WhatsApp groups, and will monitor all shared content to ensure that no inappropriate content or private information is shared in the group.
15858150|NCT03977181|Behavioral|Individual-based Adherence Support|IAS participants will be matched to a LHC and will schedule IAS sessions once-a-month for the duration of the study. These sessions will be held at a centralized location within the study community. The sessions will be semi-structured to allow for participant-driven discussion of any adherence challenges and key-messages. The adherence curriculum will also explore motivations for PrEP and adherence and focus on practical adherence tips, environmental cues, integration of PrEP within daily routines, short-term goal-setting, problem-solving, safe PrEP disclosure and social support, risk reduction counselling, partner communication, and HIV risk perception. A subset of IAS sessions will be audio-recorded for quality assurance by investigators and the study coordinator. These recordings are for training purposes only and will not form part of the dataset. Consent for recording IAS sessions will be sought from participants during the pre-enrolment consent process.
15858151|NCT03977168|Procedure|Application of circumferential pelvic compression (CPC) device|Application of circumferential pelvic compression (CPC) device used at any time within 24 hours of injury
15858152|NCT03977155|Drug|BOS-589|oral tablets
15858153|NCT03977155|Drug|Placebo|oral tablets
15858154|NCT03977142|Diagnostic Test|Radical 7 Masimo Hemoglobin pulse co-oximeter non invasive monitor|Measure hemoglobin levels non invasively by pulse co-oximeter
15858220|NCT03976518|Drug|Atezolizumab|Atezolizumab will be administered on Day 1 every 21 days (+/- 3 days).
15867604|NCT03900949|Drug|Midostaurin|Given PO
15858155|NCT03977129|Device|QFR-guided strategy|In this study, the QFR-guided strategy will be applied to in the QFR group in which calculation of the QFR values of all target coronary arteries with lesions with diameter stenosis of ≥ 50% (visual estimation) and with suitability to CABG revascularization will be carried out. If QFR ≤ 0.80, then simultaneous CABG revascularization of target blood vessels will be carried out. If QFR > 0.80, then no CABG revascularization of target blood vessels will be carried out.
15858156|NCT03977129|Other|CAG-guided strategy|In this study, CAG-guided strategy will be used for the control group, i.e., in accordance with current guideline recommendations, all target coronary arteries with lesions with diameter stenosis of ≥ 50% (visual estimation) and suited for CABG revascularization will undergo CABG revascularization.
15858157|NCT03977116|Drug|SLGT2|These patients will receive SLGT2 therapy after catheter ablation.
15858158|NCT03977116|Drug|Placebo|These patients will receive placebo therapy after catheter ablation.
15858159|NCT03977103|Biological|High dose irradiation conditioning + Treg/Tcon|High dose irradiation based conditioning regimens followed by infusion of donor regulatory and conventional T cells and purified CD34+ hematopoietic stem cell transplantation
15858160|NCT03977090|Drug|Geptanolimab Injection|GB226 3mg/kg, q2w, iv.
15858161|NCT03977090|Drug|Fruquintinib|Fruquintinib 3 or 4 or 5mg,qd,po. 3 weeks-on, 1 week-off
15858162|NCT03977077|Drug|Albumin binding taxol|125mg/m2, d1, 8, intravenous infusion for 30min, 1 cycle every 3 weeks;Other combined chemotherapy drugs and drug doses shall be administered by clinicians according to the guidelines and the actual situation of clinical patients.
15858163|NCT03977064|Behavioral|Life style change and weight reduction|Nutritional, behavioural, and exercise counselling to reduce body weight by 10%, normalise blood glucose, lipids, blood pressure, and testosterone level.
15858164|NCT03977051|Behavioral|Focus group|Kidneys transplant patients will discuss their attitudes and beliefs towards immunosuppressant medication adherence
15858165|NCT03977038|Device|repetitive transcranial magnetic stimulation|Repetitive transcranial magnetic stimulation (rTMS) is prescribed as first-line treatment for TRD patients (4). rTMS is safe, tolerable and non-invasive neurostimulation procedure where powerful magnetic pulses are transmitted through the skull into the underlying cortical cortex with the aim of electrical current induction within the neural tissue. This study administers a standard dose of rTMS treatment to the TRD patient sample consisting of high frequency deep TMS (HF-dTMS) stimulation over left dorsolateral prefrontal cortex (L-DLPFC), at the frequency of 18Hz, at 120% value of the individual's motor threshold, in 5 daily sessions per week, taking place each weekday, over the course of 6 weeks. The technology of dTMS, which will be used in this study, is an adaptation of the therapeutic intervention of rTMS with the advancement of possessing higher efficacy in targeting deeper brain regions of interest.
15858166|NCT03977025|Diagnostic Test|Lumbar punction|Patients will be evaluated prior to surgery with the Montreal Cognitive Assessment (MoCA) to determine the presence of cognitive impairment, and CSF samples, obtained by lumbar punction, will be analyzed by immunodetection of Aβ40, Aβ42, tau and ptau with multiplex technology
15858167|NCT03977012|Drug|Buprenorphine|5~20 mcg
15858168|NCT03976999|Other|Biological collection|"Blood samples collected at different times : Before treatment (T1) , after chemotherapy (T2), after interval surgery (T3) and after cancer reccurence (T4)
~Tissue samples (tumor tissue and healthy tissue) collected during the surgery"
15858169|NCT03976986|Device|continuous-flow portable oxygen concentrator (cPOC)|SeQal Eclipse 3® on continuous-flow (SeQual,Ball Ground,GA): flow rate 2 litre per minute (lpm).
15858170|NCT03976986|Device|pulsed-flow portable oxygen concentrator (pPOC)|InogenOne G3® (Inogen,Goleta,CA) on pulsed-flow mode: setting 2 (flow rate 420 ml/min, 16.8 ml +/- 3ml per bolus at 25 rpm).
15858171|NCT03976973|Drug|Bromelain, Stem|Intratumoural injections of Bromelain 15-45mg (concentration 600ug/ml) or intraperitoneal injections of Bromelain 60mg will be administered via a radiologically placed drain in combination with Acetylcysteine in 0.9% sodium chloride (normal saline).
15858172|NCT03976973|Drug|Acetylcysteine|Intratumoural injections of Acetylcysteine 1g or intraperitoneal injections of Acetylcysteine 2g will be administered via a radiologically drain in combination with Bromelain in 0.9% sodium chloride (normal saline).
15858173|NCT03976973|Procedure|Interventional radiology insertion of drain|Under radiological guidance (CT), a needle, wire, dilator will be placed directly into the tumour then a large pigtail drain (i.e. 10Fg) will be placed into the tumour by an experienced, interventional radiologist, under standard procedures.
15858174|NCT03976973|Diagnostic Test|Pathology: blood testing during intervention|Blood tests are taken 3 hours after each drug intervention then 24 hours following the last drug intervention to assess for short-term systemic side effects and measure pharmacokinetics of bromelain and acetylcysteine.
15858175|NCT03976973|Other|Routine follow up|Patients will have outpatient reviews at 1 week and 1, 3, 6, 9 and 12 months post drug intervention. Blood tests will be performed at 1 week and 1, 3, 6, 9 and 12 months after the drug intervention to assess for short and long term systemic side effects. At 1, 3, 6, 9 and 12 months post drug intervention, a CT-scan is part of the study protocol to assess for response and progression of disease.
15858176|NCT03976960|Other|Biological collection|The biological collection will also include samples of blood samples collected before or after surgery but also samples frozen and/or paraffin-embedded tissue sections.
15858177|NCT03976934|Drug|Tamsulosin|administration of tamsulosin tablets
15858178|NCT03976934|Drug|Placebo oral tablet|sugar pills
15858179|NCT03976921|Diagnostic Test|Integration of CCTA with stress CTP when indicated|When judged indicated, functional assessment with stress CTP perfusion will be performed on top of CCTA.
15858180|NCT03976921|Diagnostic Test|Standard of care approach|(a) functional non-invasive tests (stress ECG, or imaging-based tests such as Stress Echo, Stress CMR, SPECT or PET) as a gatekeeper for ICA; (b) direct referral to ICA.
15858181|NCT03976908|Device|Deep Brain Stimulation|High frequency deep brain stimulation in the medial geniculate body of the thalamus.
15858261|NCT03976258|Drug|Methadone|This is an observational study. Methadone for opioid use disorder will be provided in a standardized way by experienced providers through already established funded treatment programs.
15858184|NCT03976882|Drug|Hetrombopag|Hetrombopag oral tablet 5mg once daily for 14 days from 7 days prior to chemotherapy treatment.
15858185|NCT03976882|Drug|Placebo|Placebo oral tablet (vehicle) 5mg once daily for 14 days from 7 days prior to chemotherapy treatment.
15858186|NCT03976869|Drug|AZD7594|During treatment period, AZD7594 (360 µg per day) will be administered as oral inhalation via dry powder inhaler or DPI (SD3FL inhaler).
15858187|NCT03976856|Drug|GB226|Geptanolimab, 210mg，q2w，ivgtt.
15858188|NCT03976856|Drug|Fruquintinib|Fruquintinib, 3mg or 4mg or 5mg, qd.po. 3 weeks-on,1 week-off
15858189|NCT03976843|Drug|18F-DCFPyL|18F-labeled agent that is a high affinity small molecule inhibitor of PSMA to detect prostate cancer via PET imaging
15858190|NCT03976817|Procedure|aortic valve replacement|After median sternotomy, cardiopulmonary bypass (CPB) was established between the ascending aorta and the right atrium. The aorta was cross-clamped and a high potassium warm cardioplegia was infused and repeated every 15 minutes. The aortotomy was made above the sinuses and the aortic valve was removed. The prosthesis was chosen one size larger than the maximal sizer that could be inserted, which was also used to determine the appropriate height for insertion of the sutures along the wall of the non-coronary sinus.
15858191|NCT03976804|Other|low dose CT scan|Lung cancer screening will be based on the analysis of a low dose CT scan
15858192|NCT03976804|Other|blood sample collection|establish a phenotyping of immunity, blood inflammation and digestive and tumour microbiota
15858193|NCT03976804|Other|faecal sample collection|establish a phenotyping of immunity, blood inflammation and digestive and tumour microbiota
15858194|NCT03976791|Procedure|enlarged internal incision|enlarging the internal incision about 0.4mm
15858195|NCT03976791|Procedure|regular 2.2mm incision|2.2mm microincision coaxial phacoemulsification
15858196|NCT03976778|Other|Training program for family physicians on well-child care for children under-5 years|The researchers designed this intervention, which consisted of 3 repeated workshops, every workshop had held for 2 days, one day per week, the number of attendants was appropriate/workshop (10 - 15).
15858197|NCT03976765|Other|Rehabilitation program|The patients follow different rehabilitation programs (surgery, anesthetic, post-operative). Hospital discharge is authorized only after validation of objective, clinical and para clinic criteria
15858198|NCT03976752|Drug|Genvoya|"Genvoya is a fixed-dose combination anti-retroviral drug containing tenofovir alafenamide (TAF), emtricitabine (FTC), elvitegravir (EVG), and cobicistat.
~At the second study visit, participants will be provided with a single dose of Genvoya, and instructed to take the dose at home with documentation by digital, time-stamped photo or video. At the third study visit, which will occur 24 hours after home dosing, participants will be given another single dose of Genvoya at the clinic."
15858199|NCT03976726|Device|Comparison of physcial parameters|Increasement of weight, volume expansion and decrease of density are measured.
15858200|NCT03976713|Drug|Bufei Yishen granule|Bufei Yishen granule will be administered twice daily for five days a week for 52 weeks.
15858201|NCT03976713|Drug|Placebo Bufei Yishen granule|Placebo Bufei Yishen granule will be administered twice daily for five days a week for 52 weeks. The placebo granule consists of dextrin, bitter and 5% of the Bufei Yishen granule. The appearance, weight, color and odor of the preparation are the same as those of treatment group.
15858202|NCT03976713|Drug|Tiotropium Bromide Powder for Inhalation|Tiotropium Bromide Powder for Inhalation will be used once daily (18 μg each time) for 52 weeks.
15858203|NCT03976700|Drug|Bufei Jianpi granule|Bufei Jianpi granule is composed of many kinds of traditional Chinese medicine. The granule will be administered twice daily for five days a week for 104 weeks.
15858204|NCT03976700|Drug|Placebo Bufei Jianpi granule|Placebo Bufei Jianpi granule consists of dextrin, bitter and 5% of the Bufei Jianpi granule. The appearance, weight, color and odor of the preparation are the same as those of treatment group. The placebo granule will be administered twice daily for five days a week for 104 weeks.
15858205|NCT03976687|Drug|EYP001a|Oral tablets
15858206|NCT03976674|Behavioral|Cognitive Behavioural Therapy (CBT)|5 group sessions (2h30/session) before the surgery
15858207|NCT03976648|Drug|GLPG1690|film-coated tablets of GLPG1690 for oral use
15858208|NCT03976635|Device|Removable Mandibular Retractor|The appliance will be used 18 hours per day. It can only be removed for eating meals.
15858209|NCT03976635|Device|Bone-anchored intermaxillary traction|The patients will be instructed to wear the upper removable appliance for 18 hours per day. The elastics should be extended from the upper appliance towards the lower mini-screws.
15858210|NCT03976622|Biological|Blood samples|Blood samples: serum and PBMC
15858211|NCT03976622|Biological|Skin biopsies|These superficial skin biopsies under local anesthesia in skin areas with the exception of the face and folds.
15858212|NCT03976609|Procedure|Maxillary Expansion|The patients with maxillary transverse deficiency were treated with Haas expander is a tooth and tissue-borne appliance with a jackscrew located at the anterior region of the arch with its arms bent posteriorly and soldered to the first permanent molar bands. Once activated, the appliances opens the palatal suture and increase the transverse dimension of the maxilla.
15858213|NCT03976583|Drug|Cpp-Acp|Remineralising agent
15858214|NCT03976583|Other|Pearl powder|Natural product
15858215|NCT03976570|Behavioral|Occupational Therapy|Occupational therapy to children with subthreshold attention deficit hyperactivity disorder
15858216|NCT03976557|Device|BIP CVC|Central venous access with noble metal coated CVC
15858217|NCT03976557|Device|Standard CVC|Central venous access with standard uncoated CVC
15858218|NCT03976544|Drug|Estradiol Valerate|Estradiol valerate will be started in the beginning of the menstrual cycle in order to induce proliferation of the endometrium.
15858219|NCT03976544|Drug|Micronized progesterone|If the endometrium is considered adequately proliferated, micronized progesterone is administered and frozen-thawed blastocyst transfer will take place on the 6th day of supplementation.
15858221|NCT03976505|Other|reading a table format prescription on a touch screen|Task consists in reading on a touch screen, or on a tablet, two fictive medication prescriptions. One is presented in a table format and the other in a textual format. Each prescription comprises two regular medications (same doses and moments of the day) and two irregular medications (different doses or different moments).
15858222|NCT03976505|Other|reading a textual format prescription on a touch screen|Task consists in reading on a touch screen, or on a tablet, two fictive medication prescriptions. One is presented in a table format and the other in a textual format. Each prescription comprises two regular medications (same doses and moments of the day) and two irregular medications (different doses or different moments).
15858223|NCT03976505|Other|filling a virtual pillbox displayed on the screen as prescribed in the prescription|filling a virtual pillbox displayed on the screen as prescribed in the prescription
15858224|NCT03976505|Other|eye-tracker|In the touch-screen condition an eye-tracker is used to record eye fixations and scanpaths in real time.
15858225|NCT03976505|Other|cognitive tests and questionary|Once the 2nd pillbox filling is finished a battery of cognitive tests and questionnaires is administered to participants to identify Pd subtypes of impaired performances.
15858226|NCT03976492|Diagnostic Test|diagnostic of specific biomarkers|Protein and metabolic product differences will be detected from blood or lesion samples of normal population, patients with traumatic brain injury and/or non-brain injury using mass spectrometry proteomics and metabolomics analysis platform. Diagnostic markers of potential traumatic brain injury will be found, and their differential diagnostic values were discussed.
15858227|NCT03976479|Other|Body composition, questionnaires, biochemistry and blood pressure results|Body composition status, nutritional status, cardiovasculat status, health status, lifestyle factors
15858228|NCT03976466|Device|Antibiotic local prophylaxis with medicated calcium sulfate beads|Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection
15858229|NCT03976466|Procedure|Classical parenteral antibiotic prophylaxis|Antibiotic prophylaxis in patients with non-modifiable risk factors for periprosthetic joint infection
15858230|NCT03976440|Other|Renal Replacement Therapy (RRT) start|At the discretion of the nephrologist, treatment modality will be selected among CVVH, CVVHDF or SLED. Whatever the RRT modality, the investigators will adopt RCA as the standard anticoagulation strategy
15858231|NCT03976427|Behavioral|Guided Imagery|The guided imagery exercise asks participants to think about positive associations with healthy foods and imagine their future healthy selves.
15858232|NCT03976414|Other|eMOM|The intervention is the use of the website (eMOM), which is the electronic adaption of the program, Mind Over Matter: Healthy Bowels, Healthy Bladder (MOM), a small-group, community-based health promotion program that builds skills and self-efficacy to make behavior changes that improve urinary and bowel symptoms among older women with incontinence.
15858233|NCT03976401|Drug|EFX|Administered by subcutaneous injection
15858234|NCT03976401|Drug|Placebo|Administered by subcutaneous injection
15858235|NCT03976388|Device|Clinical Virtual Simulator|Interactive medical case delivered using touch-sensitive screens in small group sessions.
15858236|NCT03976388|Other|Small-Group Discussion|Small group discussion led by a physician.
15858246|NCT03976349|Drug|BIIB094|Administered as specified in the treatment arm.
15858247|NCT03976349|Drug|Placebo|Administered as specified in the treatment arm.
15858248|NCT03976336|Dietary Supplement|Berberine|500 mg berberine (1 capsule) with breakfast and 1000 mg (2 capsules) with the evening meal, 1500 mg total
15858249|NCT03976336|Other|Identical Placebo|500 mg (1 capsule) with breakfast and 1000 mg (2 capsules) with the evening meal, 1500 mg total
15858250|NCT03976323|Biological|Pembrolizumab|IV infusion
15858251|NCT03976323|Drug|Pemetrexed|IV infusion
15858252|NCT03976323|Drug|Carboplatin|IV infusion
15858253|NCT03976323|Drug|Cisplatin|IV infusion
15858254|NCT03976323|Drug|Olaparib|Tablets
15858255|NCT03976310|Drug|48 weeks of Benralizumab|Benralizumab is administered for 48 weeks (week 0 to week 48) every 4 weeks for the first 3 injections (30 mg sc per injection), and then every 8 weeks for the following 5 injections.
15858256|NCT03976310|Other|Computed tomography|Computed tomography of the thorax is performed at the beginning (week 0), middle (week 24) and towards the end (week 48) of Benralizumab therapy. A sinus scan is also added on weeks 0 and 48.
15858257|NCT03976297|Other|Control Tower|A workstation and software tool that extracts medical data from Mayo's data mart and electronic health record, and processes it through a prediction model that determines whether a patient is suited for a palliative care consult.
15858258|NCT03976284|Behavioral|Garden-fresh produce and exercise|The Garden-fresh produce and exercise (GFPE) health promotion intervention features 10 weekly sessions that take place after Sunday services in the Lincoln Memorial Church kitchen/meeting space. Each session includes a cooking demonstration focused on how to prepare and cook a meal composed of fiber-rich plant foods minimally processed. Each session also includes brief, didactic nutrition instruction and a 10-minute bout of physical activity.
15858259|NCT03976271|Procedure|hyperinsulinemic normoglycaemic-hypoglycaemic glucose clamp|For this study, a hyperinsulinemic normoglycaemic-hypoglycaemic glucose clamp will be conducted to investigate the effect of hypoglycaemia. This means that subjects will receive an intravenous insulin infusion, at a continuous rate of 60 mU∙m-2∙min-1, as well as glucose 20% w/w intravenously at a variable rate, adjusted by arterial plasma glucose levels, measured at 5 minute intervals.
15858260|NCT03976258|Drug|buprenorphine/naloxone|This is an observational study. Buprenorphine/naloxone for opioid use disorder will be provided in a standardized way by experienced providers through already established funded treatment programs.
15858545|NCT03973710|Dietary Supplement|Lactobacillus paracasei dietary supplement|a commercial probiotic dietary supplement
15858262|NCT03976258|Drug|Naltrexone Injection|This is an observational study. Naltrexone injection for opioid use disorder will be provided in a standardized way by experienced providers through already established funded treatment programs.
15858263|NCT03976258|Drug|Heroin|This is an observational study. Participants using heroin will be enrolled into this group.
15858264|NCT03976245|Drug|Etanercept|injection
15858265|NCT03976245|Drug|tofacitinib|tablet
15858266|NCT03976232|Device|Trans cranial Direct Current Stimulation (tDCS)|Active tDCS will be applied for 20 minutes with 2 mA intensity. Anode will be placed at left dorsolateral prefrontal cortex and cathode will be placed at the right cerebellar cortex.
15858267|NCT03976232|Other|Craniosacral therapy (CST)|Craniosacral therapy will be given to all the participants which includes release of all major diaphragm, frontal lift, parietal lift, occipital lift, CV4 and dural tube rocking.
15858268|NCT03976232|Other|tDCS+ CST|This group will receive tDCS along with CST
15858269|NCT03976219|Other|ECAPS Closed Loop SCS|The purpose of this study is to determine the feasibility of recording evoked compound action potentials (ECAPs) and somatosensory evoked potentials (SSEPs) from the spinal cord (SC) and Dorsal root ganglions (DRG), and their suitability as feedback signals.
15858270|NCT03976206|Biological|Very small embryonic-like stem cell|We carried out the subdermal application of VSELs with a 1-mL syringe (volume, 0.4 mL) coupled to a 30-gauge needle, in the left preauricular area (1-cm2 area), 2 cm distal from the tragus
15858271|NCT03976193|Behavioral|BfitBwell program|Well known behavior change strategies such as goal setting, and identifying barriers to PA can improve long term adherence to PA, and have been shown to enhance PA maintenance after completion of a supervised intervention among cancer survivors
15858272|NCT03976193|Behavioral|6 bi-weekly PA Behavior Change counseling sessions|Well known behavior change strategies such as goal setting, and identifying barriers to PA can improve long term adherence to PA, and have been shown to enhance PA maintenance after completion of a supervised intervention among cancer survivors
15858273|NCT03976180|Device|Stadard low-flow oxygen|In the control group, standard low-flow oxygen will be delivered via nasal prongs (LFNO), up to hospital discharge or secondary ACS onset, in order to achieve normoxia (target pulse oxymetry saturation of 95%). This strategy is in accordance with current recommendations and usual care
15858274|NCT03976180|Device|HFNO with low FiO2 (21%-30%)|HFNO with low FiO2 (21%-30%) targeting normoxia: to test the effect of improved pulmonary function
15858275|NCT03976180|Device|HFNO with intermediate FiO2 (50%)|In this group, FiO2 will be set at 50% during the first 24 hours of intervention to target moderate hyperoxia, then reduced to 21-3025% during the following 48 hours to target normoxia
15858276|NCT03976180|Device|HFNO with high FiO2 (100%)|In this group, FiO2 will be set at 100% during the first 24 hours of intervention to target intense hyperoxia, then reduced to 21-3025% during the following 48 hours to target normoxia
15858277|NCT03976167|Device|Oxygen administration with Common nasal cannula|Oxygen administration during elective flexible bronchoscopy in children with high flow nasal cannula with inspired oxygen fraction 1.
15858278|NCT03976167|Device|Oxygen administration with high flow nasal cannula, device Airvo2 Fisher and Pykel|
15858279|NCT03976154|Other|Thoracic Epidural Catheter Fixation Techniques|"All thoracic epidurals will be placed by a regional anesthesia resident or fellow under the direct supervision of an attending anesthesiologist using a standard epidural kit and in the paramedian approach.
~Epidural placement will occur preoperatively in the same manner as our current practice criterion. There will be no difference in placement of the epidural catheter between the control groups and the treatment group. After placement, catheters will be secured with either Dermabond, Mastisol, or a Grip-Lok fixation bandage, all with overlying Tegaderms."
15858280|NCT03976141|Diagnostic Test|mri|knee mri
15858281|NCT03976128|Behavioral|Nordic Walking Training|The excursions will take place predominantly in flat pathways, beginning in a local park and progressing to roadside footpaths. Each session will last an hour including a warm up, NW and a cool down with stretching exercises.
15858282|NCT03976128|Behavioral|Conventional endurance training|15 minutes of Treadmill training with progressive increase of velocity followed by 20 minutes of cycloergometer with progressive increase of resistance. Each session will last an hour including a warm up, training with treadmill and cycloergometer and a cool down with stretching exercises.
15858283|NCT03976115|Drug|DDO-3055|Oral
15858284|NCT03976115|Drug|Placebos|Oral
15858285|NCT03976102|Biological|DRL_RI (Proposed rituximab biosimilar)|Proposed rituximab biosimilar, 100mg and 500mg, concentrate for solution for infusion
15858286|NCT03976102|Other|MabThera®|Reference product rituximab, 100mg and 500mg, concentrate for solution for infusion
15858287|NCT03976089|Behavioral|Recipe 4 Success|"The Recipe 4 Success intervention consisted of 10 weekly lessons in which parents and toddlers prepared simple snacks or meals.
~All Recipe 4 Success lessons started and ended with some evidence-based information for the parents about children's self-regulation skills or healthy eating habits. Most of each lesson in Recipe 4 Success was devoted to the snack or meal preparation activities. Each week, home visitors coached the parents as they worked with their toddlers to make increasingly challenging snacks and meals. During these activities, home visitors pointed out opportunities for parents to practice sensitive scaffolding strategies. At the same time, these meal and snack preparation activities allowed children to practice multiple age-appropriate self-regulation skills."
15858288|NCT03976089|Behavioral|Treatment as Usual Early Head Start|Treatment as Usual Early Head Start consisted of an evidence-based curriculum (usually Parents as Teachers) in which home visitors and parents worked with children on activities to support their physical, cognitive, and social-emotional development.
15858289|NCT03976076|Drug|JBPOS0101|JBPOS0101 (investigational product)
15858290|NCT03976063|Drug|Nifedipine|Loading dose: Oral Nifedipine 20 mg LP at T0 and T0.5 (i.e. 30 min), total=2x20 mg Maintenance dose: Oral Nifedipine 20 mg LP at T3, then 1 pill every 8 hr for 48 hr (i.e. T11, T19, T27, T35 and T43, total=6x20 mg)
15858291|NCT03976063|Drug|Placebo of Nifedipine|Oral Placebo of Nifedipine 20 mg, at T0, T0.5, T3, T11, T19, T27, T35 and T43
15858370|NCT03975283|Drug|Exparel 266 MG Per 20 ML Injection|266mg of liposomal bupivacaine 266 mg, 20 mL volume, will be diluted with 20 ml of 0.25% bupivacaine (50 mg of bupivacaine) and 20 ml saline, thereby totalling 60mL volume. Total volume will be divided into two 30 ml syringes, and each will be used (per side) for the TAP blocks.
15869346|NCT03886896|Drug|Lidocaine|Lidocaine infusion during surgery
15858292|NCT03976050|Drug|HL-085|HL-085 is a MEK inhibitor with potential indication for cancers. it will be given twice daily continuously in the study until disease progression; or the risks outweigh the benefits, if the subject continues study treatment; or subjects with poor compliance; or subjects need to receive or have already started alternative anti-tumor drugs; or Subjects who need to receive or have already started alternative any other concomitant medication and/or treatment, which would significantly impact their safety; or interruption of IP administration for more than 14 days due to IP-related AEs.
15858293|NCT03976037|Drug|Misoprostol|"Women randomized to either vaginal or buccal misoprostol-cervical Foley group will have both misoprostol and a cervical Foley placed. Patients will receive 25 micrograms of vaginal or buccal misoprostol along with the insertion of a16F Foley catheter with stylet. The Foley balloon catheter will be filled with 30cc balloon inserted digitally or by direct visualization with a speculum. The Foley bulb will be placed just above the level of the internal os and inflated with 30cc of sterile water.
~vaginal or Buccal misoprostol can be repeated up to five additional times for a maximum of 24 hours or a total of 6 doses if the patient is not contracting more than 3 times per 10 minutes. If the patient is contracting more than 3 times per 10 minutes after 6 hours, oxytocin protocol is initiated."
15858294|NCT03976024|Other|DHBN-FN arm|DHBN-FN will be evaluated by pharyngeal swab, anal and perineal. If the family accepts, the carriage of streptococcus in persons living under the same roof as patients with DHBN-FN will be evaluated by pharyngeal, anal and perineal swab in consultation. These swabs will be made within 10 days of diagnosis of DHBN-FN of the index
15858295|NCT03976024|Other|Control arm (Erysipelas)|The carriage of streptococcus in patients with erysipelas will be evaluated by pharyngeal, anal and perineal swab on day 0 (admission).
15858296|NCT03976011|Device|Transcutaneous Laryngeal Ultrasonography|"TLU will be performed during the same time period of The gold standard NF (who is performed as usually after endocrine surgeries) by an investigator blind to the NF results, between D1 and D15.
~The subject will be his own control, NF and TLU being compared. When facing VF immobility, the subject will benefit from the usual clinical follow up: consultation with NF at 6 weeks and 6 months. TLU will be added to these appointments."
15858297|NCT03975998|Procedure|Mitral valve repair|Minimally invasive repair of severe organic mitral regurgiation
15858298|NCT03975985|Other|Core stability exercises (CSE)|"CSE are exercises focused on trunk muscle strengthening, proprioception, selective movements of the trunk and pelvis muscle, and coordination, and will be carried out in supine, sitting on a stable surface and sitting on an unstable surface (physioball). The exercise involves changes in the position of the body without resistance, aiming to improve strength, endurance, proprioception and coordination.
~- TENS: Half of the patients assigned to CSE will also receive TENS (highfrequency TENS 100 Hz; 0.2 ms pulse width), administered via TENS stimulator with two disposable 0.9 mm diameter electrodes placed on the skin over the lumbar erector spinae (3 cm lateral to the L3 and L5 spinous process)."
15858299|NCT03975985|Other|Conventional Physiotherapy|The common feature of CP is that it consists of a management by the physiotherapist according to the CP may consist in a variety (or combination) of multiple components such as tone normalization, exercises for maintain range of motion, passive mobilization of hemiparetic side, postural control, gait re-education to walking/standing between parallel bars or with a therapist, rehabilitation of the activity of daily living, etc.
15858300|NCT03975972|Other|Occupational Therapy Based Literacy Intervention|Use of an occupational therapy-based literacy intervention that utilizes student interest to guide a prescriptive literacy intervention. Addressing reading as an occupation and making the necessary modifications to the literacy task to allows for increased engagement in the task. Increased engagement in literacy tasks, allows for opportunities to work on literacy deficit areas to address proficiency with reading ability.
15858301|NCT03975959|Other|QMRP questionnaire|a single consultation for test and questionnaires for a duration of 20 minutes
15858302|NCT03975946|Procedure|Rheopheresis procedure|Rheopheresis is performed using an automated monitor in a double-filtration cascade. Plasma purify from of high molecular weight proteins through a secondary filter is then returned to the patient. This technique is performed in tandem with a hemodialysis monitor.
15858303|NCT03975946|Biological|Blood Sample|Biological analysis
15858304|NCT03975946|Procedure|Shamapheresis procedure|Shamapheresis is performed with the same automated monitor (Plasauto, HemaT company). Extracted plasma is not treated through the secondary filter (Rheofilter) and return to the patient. This technique is performed in tandem with a hemodialysis monitor.
15858305|NCT03975933|Diagnostic Test|Pregnancy test at Baseline|Among respondents who are randomly selected to receive a free home pregnancy test service, they will be offered the chance to take the test in the presence of the enumerator. Specifically, this would mean they would be given a cup to collect a sample of urine. The respondent would do so privately, then bring the cup back to the enumerator who would dip the home pregnancy tests and assist with interpreting the result. However, respondents can decline to take the test with the enumerator. Treatment assignment will be stratified by whether respondent use modern family planning at baseline.
15858306|NCT03975933|Diagnostic Test|Free pregnancy test for the future use|We will provide a free pregnancy test in for the future use.
15858307|NCT03975933|Diagnostic Test|Pregnancy test for the future use with randomzied price|We will provide an opportunity to buy a pregnancy test for the future use with randomized price.
15858308|NCT03975920|Device|The Restful Jaw Device|The Restful Jaw Device is used to support the jaw during dental procedures including surgical removal of 3rd molars (wisdom teeth) with sedation. The device is designed to counter the downward forces placed on the mandible by clinicians during dental procedures and prevent jaw hyperextension (opening too wide) while providing a secure, stable jaw position. When 3rd molar teeth are surgically removed with sedation, a dental assistant stands behind the dental chair and supports the patient's jaw with both hands under the patient's jaw. This device replicates the dental assistant in holding the jaw during dental procedures.
15858309|NCT03975907|Biological|CAR-BCMA T Cells|The CAR-BCMA T cells (study drug) used in this study are chimeric antigen receptor specifically expressing T cells targeting BCMA.
15858371|NCT03975283|Drug|Bupivacaine Hcl 0.25% Inj|0.25% bupivacaine, 60mL total, divided into two 30mL syringes and delivered via TAP block on either side.
15858372|NCT03975270|Drug|Sintilimab and Nab-paclitaxel|Sintilimab in Combination with Nab-paclitaxel in Patients with Advanced Recurrent or Metastatic HNSCC after 2 or More Prior Lines of Therapy
15858373|NCT03975257|Device|Medical Device: Ectoin Lozenge|Application of Ectoin Lozenge (EHT02) in accordance with the instructions for use
15858310|NCT03975894|Biological|Serial prophylactic exchange blood transfusion (SPEBT).|"Serial prophylactic exchange blood transfusion (SPEBT) will be given via automated apheresis technology. SPEBT will be carried out on the haematology day unit or on the antenatal day unit/ward in accordance with local policies in participating units. The procedure will be carried out using standard operating procedures, by the clinical or research nurse/midwife, haematology day unit staff or specialist sickle nursing staff. Venous access will be via peripheral access if possible or by femoral line access if not.
~SPEBT will be commenced between 6 and 18+0 weeks gestation. It will be repeated at 6-10 weekly intervals aiming to maintain HbS% <30%. It will continue throughout pregnancy and be stopped at the end of pregnancy.
~Number of red cell units used per transfusion will depend on patient weight and pre-transfusion HbS%, but will usually be between 6 and 8 units of red cells on each occasion of exchange transfusion."
15858311|NCT03975881|Other|application on smartphone|The aim of this study is to test the feasibility of our approach of preventing suicide relapse with the use of a smartphone application.
15858312|NCT03975868|Other|Analysis of associated factors for cut-out in internal fixation of extracapsular proximal femoral fracture.|Identification of factors for mechanical failure of internal fixation of extracapsular proximal femoral fracture in over 75 year olds
15858313|NCT03975855|Device|NeoNavia® Biopsy System|Biopsy of axillary lymph node using the NeoNavia Biopsy System. The investigator shall obtain as many/large samples as judged adequate and sufficient for diagnosis.
15858314|NCT03975842|Other|Sinonasal and otologic evaluation|"At onset, each participant had:
~sinonasal evaluation (several nasal signs and symptoms were evaluated, bilateral endoscopic nasal examination, computed tomography (CT) of the sinuses when sinus surgery became necessary).
~otologic evaluation (evaluation of middle ear status, documentations of personal history of otologic disease, otoscopic examination, pure-tone audiometry and tympanometry)"
15858315|NCT03975829|Drug|dabrafenib|dabrafenib oral, twice daily
15858316|NCT03975829|Drug|trametinib|trametinib oral, once daily
15858317|NCT03975816|Device|Analgesia nociception index|Monitor the maternity with Analgesia nociception index
15858318|NCT03975777|Other|LO|Participants will perform an acute bout of low-intensity cycling (11 x 1 min intervals at ~73% of peak aerobic work rate interspersed with 1 min recovery periods)
15858319|NCT03975777|Other|HI|Participants will perform an acute bout of high-intensity cycling (8 x 1 min intervals at ~100% of peak aerobic work rate interspersed with 1 min recovery periods)
15858320|NCT03975764|Diagnostic Test|Collection of fecal sample|Analysis of fecal microbiome
15858321|NCT03975751|Diagnostic Test|The Glasgow Coma Scale (GCS)|Use the common GCS, RASS and self-reported pain assessment for evaluating consciousness, agitation/sedation and analgesia.
15858322|NCT03975738|Other|To be part of a blog|To be part of a blog - to respond to questions and free to comment on other participants comments
15858323|NCT03975725|Device|the use of the WitCard|electrocardiogram (ECG)
15858324|NCT03975725|Other|the use of WitDisplayer|a software to visualize, measure, annotate, comment, archive, and share the different ECGs acquired with the WitCard (ECGW) of different patients.
15858325|NCT03975712|Other|Not applicable, no intervention|Not applicable, no intervention
15858326|NCT03975699|Other|Assessment of psychological repercussions of SCD|Quantitative relevant data culled from medical files and qualitative analysis based on data gathered from child and parent interviews, were collected in the three hospitals.
15858327|NCT03975686|Other|neuromuscual realigning exercise|neuromuscular realigning exercise
15858328|NCT03975673|Procedure|hip replacement|Osteoarthritic patient undergoing the conventional technique or the kinematically aligned technique
15858329|NCT03975660|Device|Pain Measurement Device|When participants request labor analgesia, the sensor of the pain measurement device (ROPA System (CereVu Medical, Inc. San Francisco, CA) ) will be applied to the forehead and connected to the device. Data recording is then started.
15858333|NCT03975634|Device|Transcutaneous Spinal Stimulation|Safety and feasibility will be monitored during transcutaneous spinal stimulation in children with spinal cord injury
15858334|NCT03975621|Behavioral|Supportive Care|"Patient will receive the tablet, a pedometer (to track their steps) and an exercise band (to complete the exercise videos). Use of Nurse AMIE while receiving intervention phone calls from a patient navigator.
~After 90 days, observation begins and the patient will be asked to continue using Nurse AMIE without a patient navigator's presence."
15858335|NCT03975608|Behavioral|"Adaptation of CALM"|"The therapy is built up by 3-8 sessions (duration about 45-60 min) over a period of 6 months. All dimensions are explored with every patient, but the order and extent of each dimension are adapted to the individual needs of the patient.
~The sessions address the 4 dimensions of the original program designed for palliative cancer patients:
~Symptom management and communication with healthcare providers
~Changes in self and relations with each others
~Spirituality, sense of meaning, and purpose
~Thinking of the future, hope, and mortality
~As an adaptation, the investigators will especially focus on two other aspects which take into account the specific symptoms and challenges in patients with ALS: (i) communication skills and (ii) emotional expression and control."
15858336|NCT03975595|Behavioral|Meditation Intervention A|This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding.
15858337|NCT03975595|Behavioral|Meditation Intervention B|This will be a brief meditation intervention involving guided breathing and/or attention exercises. Further information is withheld to preserve blinding.
15858338|NCT03975569|Other|Probiotic vaginal gel|Total daily administration of 2.5 ml of probiotic gel, containing three lactobacilli (Lactobacillus rhamnosus GG, Lactobacillus pentosus KCA1 and Lactobacillus plantarum WCFS1). Final dosage per gram of gel: 10^9-10^10 colony forming units of lactobacilli.
15858339|NCT03975556|Behavioral|Culturally tailored food and diet advice|Puerto Rico-tailored education includes strategies for healthy eating, preferences for traditional healthy foods, recommendations for limiting unhealthy traditional foods, portion sizes, etc.
15858340|NCT03975556|Behavioral|Standard healthy eating advice|Standard healthy eating education includes strategies, foods, portions, and cooking and eating tips included in the My Plate dietary recommendations
15858412|NCT03974932|Drug|Ibuprofen|NSAID.
15858341|NCT03975530|Behavioral|Precision Family Spirit|Family Spirit home-visiting sites from the Inter-Tribal Council of Michigan (ITC of MI) will be selected based on comparability and randomized to provide either Standard Family Spirit or Precision Family Spirit to their clients. Both groups will receive educational Family Spirit lessons. Each lesson will take about 60 minutes. Participants will receive a customized version of Family Spirit that is unique to your circumstances. The two sites randomized to provide the Precision approach will receive additional training on how to provide it.
15858342|NCT03975530|Behavioral|Standard Family Spirit|Family Spirit home-visiting sites from the Inter-Tribal Council of Michigan (ITC of MI) will be selected based on comparability and randomized to provide either Standard Family Spirit or Precision Family Spirit to their clients. The investigators will select four sites and randomize two of them to Standard Family Spirit and two to Precision Family Spirit.Both groups will receive educational Family Spirit lessons. Each lesson will take about 60 minutes. Participants will receive Family Spirit lessons based on a standard program schedule.
15858343|NCT03975517|Behavioral|PrEP|Define the behavioral characteristics of the active file of patients using PrEP in Strasbourg in 2019.
15858344|NCT03975504|Device|Low Dose Computed Tomography|LDCT were performed in screening arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 5 mm
15858345|NCT03975491|Behavioral|Moderate-Intensity Aerobic Exercise|The exercise intervention will consist of moderate-intensity (50-70% age-predicted maximum heart rate) treadmill walking. All exercise sessions will begin with a five-minute warm up of slow walking, 30-60 minutes of moderate-intensity walking, and a five-minute cool down of slow walking.
15858346|NCT03975491|Behavioral|Wait-List Control|Participants randomized into the wait-list control group are asked to maintain their pre-study levels of physical activity and follow the recommendations provided by their physician.
15858347|NCT03975478|Procedure|Gastric bypass|The GB technique consists of a 150-cm antecolic Roux limb with a 25-mm circular pouch-jejunostomy and exclusion of 50 cm of the proximal jejunum.
15858348|NCT03975478|Procedure|Sleeve gastrectomy|The SG technique consists of a longitudinal resection of the stomach from the angle of His to approximately 5 cm proximal to the pylorus, using a 35 French bougie inserted along the lesser curvature.
15858349|NCT03975465|Behavioral|Expiratory Muscle Strength Training|8 weeks of EMST at 75% maximum expiratory pressure (MEP)
15858350|NCT03975465|Behavioral|Pharyngeal Muscle Strengthening Exercises|8 weeks of exercises designed to increase pharyngeal muscle strength for swallowing
15858351|NCT03975452|Radiation|Reduced radiation volumes|Patient treated with reduced radiation volumes with the exclusion of elective pelvic nodal irradiation
15858352|NCT03975439|Diagnostic Test|Hemoglobin A1C|Finger stick hemoglobin A1C
15858353|NCT03975439|Diagnostic Test|Urinalysis|Urinalysis by dip stick looking for urine protein level
15858354|NCT03975439|Diagnostic Test|Whole blood creatinine level|Finger stick looking for serum creatinine as an estimate of renal function
15858355|NCT03975426|Procedure|open reduction and internal fixation with fixation by absorbable screws|Group A received conservative therapy involving bed rest with the affected lower extremity positioned with the hip and knee in flexion to ensure minimal tension of the muscles attached to the ASIS avulsion fracture. Group B received open reduction and internal fixation with fixation by absorbable screws.
15858356|NCT03975413|Other|Fecal Microbiota Transplantation (FMT)|Longitudinal FMT study: Baseline, 3 week, 13 week, 26 week, 39 week, 52 week
15858357|NCT03975400|Behavioral|search engine advertisement campaign|This proposal aims to explore whether targeted and proactive online outreach through search engine advertisements, coupled with engaging, informative, and interactive online resources, can effectively reduce the duration of untreated psychosis and facilitate earlier treatment initiation in New York State.
15858358|NCT03975387|Drug|ASTX295|ASTX295 orally once a day for 28 days of each 28-day cycle.
15858359|NCT03975374|Drug|Tobramycin/dexamethasone opthalmic solution|To compare efficacy and safety in randomized patients recieving Tobradex versus Tobramycin/Dexamethasone opthamic Solution
15858360|NCT03975374|Drug|Tobradex Opthalmic Solution|Tobradex Opthalmic Solution
15858361|NCT03975361|Other|Bliss-Believe|The samples from the blood samples carried out within the framework of Bliss Believe will be collected for a biological collection. Only one sample of patients included in BLISS BELIEVE STUDY will be obtained during a standard of care visit. It will be 21ml of blood.
15858362|NCT03975348|Device|High flow nasal cannula|High flow of warm and humidified oxygen/air mixture delivered through nasal cannula
15858363|NCT03975348|Device|Continuous positive airway pressure|Positive airway pressure applied through a sealed face mask
15858364|NCT03975348|Device|Facemask|Oxygen therapy through a conventional facemask
15858365|NCT03975335|Behavioral|Health education|In this health education intervention, emphasis is given on evoking adolescents' internal desire to change, supporting self-efficacy to be changed, guiding self-regulatory ways along with facilitating desired changing process by empowering them with choices and skills.
15858366|NCT03975335|Other|Carrier Guidance|Carrier opportunities and counselling
15858367|NCT03975296|Procedure|preoperative single-shot TMQLB|"The patient is placed in the lateral position. The curved probe of Ultrasound Scanner is used for scan and located vertical to the iliac crest at the posterior axillary line to find the Shamrock sign. The 22-G needle is then inserted in plane and directed to the QL muscle. After the proper position of the needle tip between the psoas major muscle and the quadratus lumborum muscle is confirmed, 0. 6 ml/kg 0.5% ropivacaine is injected into the interfascial plane.
~Followed by IPCA in the first 48h after surgery: morphine boluses: 1.5-2 mg, lockout time :10 min, 1h limitation: 6-8 mg morphine."
15858368|NCT03975296|Procedure|preoperative single-shot TPVB|The patient is placed in the lateral position, the spinous processes of T10 are identified and marks are made 2cm lateral to the spinous processes. The curve probe of ultrasound scanner is placed transversally at the mark to identify the paravertebral space. Then a 22-G needle is inserted in-plane from lateral to medial and advanced until the tip reached the paravertebral space surrounded by the parietal pleura and the superior costotransverse ligament. 0.4 ml/kg 0.5% ropivacaine is injected into the paravertebral space of T10.
15858369|NCT03975296|Drug|patient controlled intravenous analgesia(PCIA)|at the end of surgery, patient is administered a PCIA with morphine boluses: 1.5-2 mg, lockout time :10 min, 1h limitation: 6-8 mg morphine.
15858413|NCT03974932|Drug|Acetaminophen|Analgesic.
15858414|NCT03974932|Drug|Celecoxib|NSAID.
15858374|NCT03975244|Behavioral|Exercise program|Twelve-week of semi-supervised exercise program. The exercise program will combine resistance and endurance training. Both the volume and intensity of training will start at moderate intensity, and progressively be increased at higher volumes and intensities.
15858375|NCT03975231|Drug|Dabrafenib|Given PO
15858376|NCT03975231|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
15858377|NCT03975231|Drug|Trametinib|Given PO
15858378|NCT03975218|Other|Patients With Stroke|In addition to the usual care, the patient will have to complete a questionnaire analyzing the regularity of his follow-up by a physician.
15858379|NCT03975205|Drug|Doxorubicin|To measure bioavailabity of Doxil versus Doxorubicin
15858380|NCT03975192|Device|Percutaneous Electrical Nerve Field Stimulation|Placement of the PENFS device immediately following the last scheduled opiate dose in the PICU with active stimulation for 120 hours.
15858383|NCT03975166|Drug|Test Product|2 inhalations in one study period
15858384|NCT03975166|Drug|Reference Product|2 inhalations in one study period
15858385|NCT03975153|Biological|guselkumab|Treatment at the FDA-approved psoriasis dosing for 20 weeks
15858386|NCT03975140|Procedure|Hypersensitive acupoint group|The first five acupoints in the sensitization sequence were pressed using the traditional Chinese medicine acupoint pressing technique, and each acupoint was pressed for two minutes.
15858387|NCT03975140|Procedure|Hyposensitive acupoint group|The last five acupoints in the sensitization sequence were pressed using the traditional Chinese medicine acupoint pressing technique, and each acupoint was pressed for two minutes.
15858388|NCT03975127|Other|SMS text|A single SMS text sent to women under 30 who are eligible for the cervical screening programme and who have been invited by letter
15858389|NCT03975114|Drug|Chemotherapy|Any approved first line chemotherapy regimen at Investigators' choice
15858390|NCT03975114|Drug|Durvalumab|Durvalumab 1500 mg iv Q4w until progressive or unacceptable toxicity or patient's refusal
15858391|NCT03975114|Drug|Tremelimumab|Tremelimumab 75 mg iv Q4w for 4 administrations (4 months)
15858392|NCT03975101|Biological|very small embryonic-like stem cell|Mononuclear cells were collected from peripheral blood of each patient using a machine, VSELs were isolated, and each group was injected according to different numbers after activation
15858393|NCT03975088|Procedure|Sub-macular injection of Ranibizumab|In this study, authors describe a new surgical technique for the treatment of refractory non tractional DME. The technique consists of vitrectomy with ILM peeling with subretinal injection of Ranibizumab.
15858394|NCT03975075|Behavioral|Psychophysiological monitoring|30 minutes of one channel (ECG) physiological monitoring with Mindfield eSense Pulse.
15858395|NCT03975075|Behavioral|Biofeedback training|Traditional resonance frequency training with the Mindfield eSense Pulse smartphone application. Using visual feedback of real time parameters of HRV and the use of controlled breathing, participants are trained to reach a relaxed state.
15858396|NCT03975062|Drug|dabigatran etexilate|150 mg twice daily (BID)
15858397|NCT03975049|Radiation|Chemoradiation|Fluorouracil 225 mg/m2/day continuous intravenous infusion on weekdays for five weeks; local irradiation 2GY/day on weekdays, totally 50GY.
15858398|NCT03975049|Drug|FOLFOXIRI Protocol|Oxaliplatin 85 mg/m2 on day 1; irinotecan 150 mg/m2 on day 1; leucovorin 400 mg/m2 on day 1; fluorouracil 2400 mg/m2 civ over 46h; treatment will be repeated every 14 days; prophylactic G-CSF support is recommended.
15858399|NCT03975049|Drug|Folfox Protocol|Oxaliplatin 85 mg/m2 on day 1; leucovorin 400 mg/m2 on day 1; fluorouracil 400 mg/m2 bolus and 2400 mg/m2 civ over 46h; treatment will be repeated every 14 days.
15858400|NCT03975036|Drug|Anlotinib|Anlotinib Hydrochloride Capsules
15858401|NCT03975036|Drug|pd-1 antibody|Pembrolizumabinjection
15858402|NCT03975023|Device|NeuroCatch Platform (NCP)|The NCP plays a proprietary 6-minute auditory stimulus sequence of tones and words that elicit involuntary evoked responses in the brain. Tone stimuli elicit N100 and P300 responses, and spoken word pairs elicit N400 responses. The NCP proprietary software identifies the latency and amplitude (timing and size) of three selected ERPs. Latency and amplitude values are reported as empirical (measured) values.
15858403|NCT03975010|Drug|Buprenorphine Transdermal Patch|"This is an open-label, randomised, single-dose, 3 arms study design. Subjects will be randomised into one of 3 arms, in a 1:1:1 ratio, wearing BUP TDS 20 mg for 3 days or 40 mg for 3 days or 40 mg for 4 days. Safety follow-up will be planned at 7~9 days after patch removal.
~The study patch will be applied under the cover of naltrexone to reduce opioid related side-effects. Naltrexone 50 mg will be taken orally every 12 hours, from the evening of Day 00 (13 hours prior to IMP application), until the evening of the patch removal."
15858404|NCT03974997|Diagnostic Test|Determination of the circulating serum concentration of cytoquine TWEAK|Blood samples (20 ml of blood on dry tube) by venipuncture at the bend of the elbow will be made at T0, then monthly for a period of 1 year . The sera will be isolated by centrifugation and then frozen at -80 degrees Assays of the soluble form of TWEAK and TNF will be performed by ELISA blot technique developed by the team.
15858405|NCT03974984|Procedure|Colon Resection|All patients undergo laparoscopic colon cancer resection.
15858406|NCT03974984|Procedure|Epidural anesthesia|Epidural inserted preoperatively and kept for 1 day postoperatively
15858407|NCT03974984|Drug|NSAID|NSAID administered according to standard operating procedure postoperatively
15858408|NCT03974958|Genetic|Tissue-library|circulating biomarkers (miRNA panel) analysis of blood samples
15858409|NCT03974945|Device|Passive-elastic prosthetic foot|The investigators will measure the biomechanics (motion, forces, and muscle activity) and metabolic rates while subjects walk using their own passive-elastic prosthesis with and without visual feedback of peak propulsive force targets.
15858410|NCT03974945|Device|Powered ankle-foot prosthesis|The investigators will measure the biomechanics (motion, forces, and muscle activity) and metabolic rates while subjects walk using a battery-powered ankle-foot prosthesis with and without visual feedback of peak propulsive force targets.
15858411|NCT03974932|Drug|HTX-011|Dual-acting local anesthetic. Dose 1.
15858419|NCT03974906|Other|Applying goal-directed fluid therapy by continuous hemodynamic monitoring system (LiDCO）|Applying continuous hemodynamic monitoring system ( LiDCO) to monitor Stroke Volume Variation and Cardiac Output and further manage intra-operative fluid therapy.
15858420|NCT03974893|Other|Vegetarian Diet|Dietary information will be collected utilizing a food record at four time points in therapy reflecting different intensities/drug exposures of treatment.
15858421|NCT03974867|Drug|Prednisone 5Mg Tab|"Glucocorticoids:
~d1-d7: Oral Pred. 1mg/kg/d a (maximum daily dosage is no more than 60mg); d8-d9: Oral Pred. 10mg less than d7; d10-d11: Oral Pred. 10mg less than d9; d12: Oral Pred. 10mg less than d11; d13: Oral Pred. 10mg less than d12; d14: Oral Pred. 10mg less than d13;"
15858422|NCT03974867|Drug|Methylprednisolone 40 mg|"Glucocorticoids:
~7 intratympanic injections of 40mg/ml Met. in 14 days, one injection every other day;"
15858423|NCT03974854|Drug|XELOXIRI-3|chemotherapy with XELOXIRI-3 regimen
15858424|NCT03974854|Drug|Gemcitabine|chemotherapy with Gemcitabine regimen
15858425|NCT03974841|Procedure|laparoscopic cornual resection|patients undergoing laparoscopic cornual resection due to cornual ectopic pregnancy
15858426|NCT03974828|Device|Anesthesia Control Tower Notification|Real-time data will be monitored through the AlertWatch system as well as the electronic health record. Risk forecasts of adverse events (30 day mortality, acute kidney injury, postoperative delirium, respiratory failure), PACU length of stay, and hospital length of stay will be generated by a machine learning algorithm. Additional outputs identifying the most important predictors and their effects will be combined with risk forecasts to form a report card.
15858427|NCT03974815|Device|ACTIVE|"We will use 28.26cm^2 round electrodes and a 2mA current for 30 minutes per day. This montage is known as bifrontal setup(F3-Anode, F4-Cathode) and has been previously used in major depression trials."
15858428|NCT03974815|Device|SHAM|"We will use 28.26cm^2 round electrodes and a 0mA current for 30 minutes per day. This montage is known as bifrontal setup(F3-Anode, F4-Cathode) and has been previously used in major depression trials."
15858429|NCT03974802|Device|somofilcon A contact lens|Contact Lens
15858430|NCT03974802|Device|fanfilcon A contact lens|Contact Lens
15858431|NCT03974789|Diagnostic Test|Blood test|Plasma cortisol level test
15858432|NCT03974789|Diagnostic Test|24-hour Urine test|Urinary free cortisol test
15858433|NCT03974789|Diagnostic Test|Saliva swab|salivette® for salivary cortisol quantification
15858434|NCT03974789|Diagnostic Test|Dexamethasone test|Dectancyl® 2 x 0.5 mg tablets (total 1 mg)
15858435|NCT03974776|Biological|PF-06946860|PF-06946860 administered subcutaneously
15858436|NCT03974776|Other|Placebo|Placebo administered subcutaneously
15858438|NCT03974737|Device|CRI device (non-invasive vitals sign measurement)|Survey administration, Orthostatic vital measurements
15858439|NCT03974711|Other|"In this evaluation, no interventions are performed. It is a data collection effort only. The procedure for this study is the data collection effort."|There is no intervention performed in this evaluation. Data is being collected in an on-label standard of care lateral lumbar interbody fusion procedure.
15858440|NCT03974698|Procedure|Hemiarthroplasty|Radiological features comparing the femoral stem position is measured on the postoperative x-ray. Presence of heterotopic ossification is assessed on the 12 months follow up.
15858441|NCT03974685|Drug|99mTc niacinamide polyethylene glycol bicyclic RGD peptide (99mTc-3PRGD2)|Single dose
15858442|NCT03974672|Procedure|Re-laparotomy|
15858443|NCT03974659|Combination Product|Transcranial magnetic stimulation|1.Patients were given 10 consecutive days bilateral cerebellar VIIa lobules Theta Burst Stimulation which was a special mode of Transcranial magnetic stimulation from one week after surgery Intermittent Theta Burst Stimulation(Positive stimulation) is used in right cerebellar VIIa lobule.Each stimulus had three 50 Hz monopulses, which were repeated every 200 ms. Each stimulation continued for 2 seconds and rested for 8 seconds. The total intervention time was 200s (600 pulses) Continuous Theta Burst Stimulation(Negative stimulation) is used in left cerebellar VIIa lobule,three 50 Hz monopulses in each stimulus, each with an interval of 200 ms, and each intervention lasted 40s (600 pulses).
15858444|NCT03974646|Behavioral|Nurse-led self-management Program|Group-based sessions will be scheduled at week two, week four and week six. Participant will be given a printed booklet Participants will receive three individual follow-up phone calls of 20-30 minutes each at week three, week five and week seven.
15858445|NCT03974633|Combination Product|Injection|All information is included in the Arm/group descriptions
15858446|NCT03974620|Behavioral|Individual Placement and Support|Individual Placement and Support is a vocational support program that was developed in the USA, to facilitate return to employment in individuals with severe and enduring mental illnesses.
15858447|NCT03974620|Behavioral|Cognitive Remediation Therapy|This is an evidence based intervention that aims to improve cognitive functioning.
15858448|NCT03974607|Behavioral|Physical Activity Program (PAP)|A Physical Activity Program (PAP) will be carried out. Previously an initial measure will be made to know the little active adolescents. At the end of the PAF a retention measure will be carried out to know the scope and persistence of the variables analyzed. The PAF will be developed with a frequency of three weekly sessions, of 60 minutes, in the period of the intervention, with the exception of weeks in which there is a public holiday, where we will take measures to recover the class. A schedule for the sessions will be set according to the interests of the participants and will be the same for all. During the sessions, basic physical abilities and motor skills will be worked on with playful proposals focused on the improvement of physical and psychosocial parameters. They will always have the same monitor Graduate in Physical Activity and Sports Sciences, which will be responsible for developing the PAF.
15858449|NCT03974594|Drug|Trifluridine and Tipiracil Tablets|Trifluridine and Tipiracil Tablets given 20mg orally once under fasting or postprandial conditions per cycle
15858450|NCT03974594|Drug|TAS-102|TAS-102 given 20mg orally once under fasting or postprandial conditions per cycle
15858451|NCT03974581|Other|Primary percutaneous coronary intervention|Patient receives primary percutaneous coronary intervention as part of his treatment; decision to allocate by treating physician.
15858546|NCT03973710|Dietary Supplement|Placebo controls|placebo with a similar appearance to probiotics supplement
15858452|NCT03974581|Other|Pharmacoinvasive strategy|Patient receives primary fibrinolysis and subsequent coronary angiography (pharmacoinvasive strategy) as part of his treatment; cases with failed fibrinolysis are scheduled for immediate rescue PCI. Decision to allocate by treating physician.
15858453|NCT03974542|Behavioral|telephone outreach|The navigator should make at least five (5) attempts to reach the participants on different days (at least one (1) attempt in weekend) and different time slots (at least one (1) attempt each in am, pm and evening). If the navigator only reached voice mail after the 1-month intervention period, a standard script will be read and a contact number will be provided.
15858454|NCT03974529|Behavioral|Intensive running|The patients who are assigned to this group will be required to finish a 90 minutes of training protocol, containing 30 minutes' warm-up stretching, and 60 minutes of supervised progressive aerobic endurance track running. The training takes place two time per week, for 24 weeks.
15858455|NCT03974529|Behavioral|Physiotherapy|The patients who are assigned to this group will be required to finish a 60 minutes of physiotherapy session. The training takes place once per week, for 24 weeks.
15858456|NCT03974516|Drug|Careseng 1370|Careseng 1370 should be taken around 1 hour before meal.
15858457|NCT03974503|Behavioral|Exposure, Relaxation, and Rescripting Therapy|ERRT is a weekly 5-session treatment aimed at reducing chronic trauma nightmares and sleep disturbances in trauma-exposed adults.
15858458|NCT03974503|Behavioral|Sleep and Nightmare Management|This is a manualized protocol developed to be of similar length but exclude the active components of standard ERRT.
15858459|NCT03974490|Other|Rhythmic auditory stimulation|Rhythmic auditory stimulation 3 times in a week, and 2 hours of physiotherapy 6 days in a week.
15858460|NCT03974477|Device|SALT CONTROL H equipment to control and monitor salt during cooking process|Participants will use SALT CONTROL H at home during 8 weeks to cook meals with adequate salt content.
15858461|NCT03974464|Diagnostic Test|copeptin, PS100|"Age, sex and time between dizziness onset and ED visit were collected using Resurgences® software. PS100 concentrations were measured on serum samples by electro-chemiluminescence assay. Copeptin concentrations were measured on serum samples by the Kryptor method. The positivity threshold for copeptin was set at strictly above 10 pmol/L and that of PS100 was set at strictly above 0.105 μmol/L.
~And after, we compared results with results of brain imaging: Magnetic Resonance Imaging alone, CT scan alone or both. Depending on clinical presentation, the imaging tests were performed during ED stay, during hospitalization or externally. Presence or absence of stroke was established on diffusion-weighted brain MRI . In case of normal contrast CT alone, a specialized opinion should exclude the need for diffusion-weighted MRI according to clinical presentation."
15858462|NCT03974451|Device|IOL implantation experimental|Implantation of of PhysIOL trifocal FineVision® POD F IOL
15858463|NCT03974451|Device|IOL implantation active comparator|Implantation of the Abbott Medical Optics, Inc. Tecnis Symfony® IOL
15858464|NCT03974438|Procedure|Superficial dry needling / Acupunture|Se arm-description.
15858465|NCT03974425|Drug|Aflibercept Injection [Eylea]|intravitreal injection of Aflibercept in resistant DME.
15858466|NCT03974412|Diagnostic Test|Head Up Tilt Table (HUT)|"Participant randomized to open-label diagnostic strategy. Results and all follow-up care to be in the hands of treating cardiologist as this is a pragmatic study.
~the early HUT [protocol: supine pre-tilt phase 5 min, un-medicated HUT to 70 degrees for 20 minutes; if response negative then 400 μg of sublingual nitroglycerin and continued 70 degree tilt for 20 minutes]"
15858467|NCT03974412|Device|Implantable Loop Recorder|ILR is a small subcutaneously implanted device, lasting up to 3 years, that records heart rhythms, and which may be either auto-triggered or patientactivated.
15858468|NCT03974399|Dietary Supplement|Bacopa Monnieri|subjects will take Bacopa Monnieri daily for 3 months
15858469|NCT03974386|Device|oXiris blood purification set|Continuous venovenous hemofiltration and adsorption (CVVHA) with oXiris filter for up to 72 hours if required. The filter will be replaced every 24 hours. The setting of CVVHA is as follows: blood flow rate 200 mL/min, replacement fluid rate 2000 mL/hr, pre-dilution 50% and post-dilution 50%. If continuous renal replacement therapy is indicated after 72 hours, conventional hemofiltration filters will be used.
15858470|NCT03974373|Procedure|BFP removal|The surgical procedure was performed using the technique with intrabuccal access, already consecrated in the literature (Materasso 2006). The Bichat fat ball access was made by means of a small incision no more than 3 mm in length in the soft tissue located in the lower aspect of the zygomatic counterfoot, taking care to visualize and protect with the retractor the Stensen's conduit. With the aid of blunt-tipped or hemostatic scissors dissection was performed, taking care to preserve the membrane surrounding the ball of fat. After removal of one side, pressure was removed to remove air and the procedure was started on the opposite side, after the removal of the two sides was realized simple suture with silk thread. There were no formal indications for sending the samples for anatomic and / or histological examination.
15858471|NCT03974360|Drug|AMG 334|100 subjects with persistent post-traumatic headache will be allocated to receive monthly subcutaneous injections of 140 mg erenumab at three time points (week 0, week 4, week 8)
15858472|NCT03974334|Behavioral|OWL-Hypertension 8 Wk Trial|Our Whole Lives - Hypertension is an innovative online community and self-management program that provides access to stress reduction, mind-body techniques, nutrition, exercise, and peer support. OWL-H provides educational materials including videos of clinician-led talks (stress reactivity, nutrition, movement, etc.). OWL-H also provides subjects a facilitated community blog, private journal, peer support, and an extensive resource library. It will be tested by 26 patients with hypertension, to refine the platform based on patient feedback and outcomes.
15858473|NCT03974308|Other|Comprehensive physiotherapy including balneotherapy and filling questionaire|Three-week stay in a sanatorium with comprehensive physiotherapy including balneotherapy and three time filling questionaire.
15858474|NCT03974308|Other|Comprehensive physiotherapy without balneotherapy and filling questionaire|Two-week outpatient treatment with comprehensive physiotherapy without balneotherapy and three time filling questionaire
15858475|NCT03974308|Other|No intervention, only filling questionaire|No physiotherapy nor balneotherapy applied but three time filling questionaire
15858476|NCT03974295|Behavioral|Vaginal unprotected intercourse|Patients will allowed to engage in vaginal unprotected intercourse as many times as desired after 24 hours of pelvic rest after a frozen embryo transfer.
15858477|NCT03974282|Other|University enrollment|Enrolled at the university
15869470|NCT03885921|Drug|Ezetimibe|oral tablet
15858478|NCT03974269|Procedure|TAVI : Transcatether Aortic Valve Implantation|TAVI procedures will be either Medtronic Corevalve, or Edwards Sapien implantations, at operator's discretion. All procedures will be supervised by one of the two senior interventional cardiologists. Hypnosis sessions will be performed by two trained anesthesiologists, and Remifentanil sedations will be administered by the rest of the anesthesiologists staff. Postoperative care will be provided in the CICU for the 3 first postoperative days at least.
15858479|NCT03974256|Other|Training in the use of the automaton|2 days training on automaton use
15858480|NCT03974243|Drug|Chiauranib|"In the lead-in period, patients take 50mg Chiauranib capsules on the forth day .
~In the subsequent treatment cycles, Chiauranib capsules are given orally once daily, 28 days as a cycle."
15858481|NCT03974243|Drug|Chidamide|In the lead-in period, patients take a single dose of Chidamide tablet on the first day and then off for 3 days before the first cycle begins. In the subsequent treatment cycles, Chidamide tablets are given orally on Day 1,4,8,11,15,18,22 and 25 of each cycle. 28 days as a cycle
15858482|NCT03974230|Other|Collection of datas|Collection of datas of examination for diagnosis and follow-up of the Fuchs Endothelial Corneal Dystrophy (FECD) including slit lamp results will be performed.
15858483|NCT03974230|Biological|blood sample|Blood sample will be performed (genetic analyses).
15858484|NCT03974230|Other|slit lamp examination|Slit lamp examination will be performed.
15858485|NCT03974217|Drug|Talazoparib|Talazoparib is a drug that stops the activity of a protein called poly (adenosine diphosphate [ADP]-ribose) polymerase or PARP. PARP is involved in repairing damage to the DNA within the cells. When PARP is turned off by Talazoparib in cancer cells, DNA damage cannot be repaired and leads to the death of the cancer cells.
15858486|NCT03974204|Procedure|Cerebrospinal fluid and blood sample collection at the initial diagnostic assessment|At the initial diagnostic assessment, 3mL of cerebrospinal fluid and 10 ml of blood sample will be collected in order to determine the proteomic profile. Cerebrospinal fluid will be collected during a lumbar puncture aiming to diagnose leptomeningeal metastases.
15858487|NCT03974204|Procedure|"Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are Lack of evidence according to EANO-ESMO classification"|"3mL of cerebrospinal fluid and 10 ml of blood sample will be collected:
~When suspected metastatic meningitis symptoms arise and
~at least 3 months after the initial diagnostic assessment, In order to determine the proteomic profile. Cerebrospinal fluid will be collected during a lumbar puncture aiming to diagnose leptomeningeal metastases."
15858488|NCT03974204|Procedure|"Cerebrospinal fluid and blood sample collection if conclusions of initial diagnostic assessment are confirmed, probable or possible, leading to leptomeningeal metastase specific treatment"|"3mL of cerebrospinal fluid and 10 ml of blood sample will be collected:
~1 month after the beginning of the specific treatment,
~3 months after the beginning of the specific treatment. Cerebrospinal fluid will be collected during a lumbar puncture aiming to assess treatment response or at intrathecal injection of treatment."
15858489|NCT03974191|Other|Change in function, activity, participation and other health related factors in CLBP and to identify predictors for pain, activity and work ability after 13 years.|13-year prospective longitudinal cohort study
15858490|NCT03974178|Drug|Fexinidazole|Adults and Children patients will receive fexinidazole tablets every day for 10 days
15858491|NCT03974165|Other|Cereal-legume product 1|The intervention examines the effect of cereal based product fortified with legumes-1 in appetite regulation in 1) subjects with normal body weight and 2) overweight subjects.
15858492|NCT03974165|Other|Cereal-legume product 2|The intervention examines the effect of cereal based product fortified with legumes-2 in appetite regulation in 1) subjects with normal body weight and 2) overweight subjects.
15858493|NCT03974165|Other|Cereal product|The intervention examines the effect of cereal product in appetite regulation in 1) subjects with normal body weight and 2) overweight subjects.
15858494|NCT03974165|Other|Reference food|The intervention examines the effect of reference food in appetite regulation in 1) subjects with normal body weight and 2) overweight subjects.
15858495|NCT03974152|Other|Subox Mini C with Avail 18 mg nicotine salt (protonated)|Participants will be instructed to take one puff of the Subox Mini C with Avail 18 mg nicotine salt (protonated) liquid every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use the product ad lib, i.e., as much as desired.
15858496|NCT03974152|Other|Subox Mini C with Avail 18 mg nicotine (unprotonated)|Participants will be instructed to take one puff of the Subox Mini C with Avail 18 mg nicotine (unprotonated) liquid every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use the product ad lib, i.e., as much as desired.
15858497|NCT03974152|Other|Own brand cigarette|Participants will be instructed to take one puff of a cigarette matching their typical brand every 30 seconds for 5 minutes followed by a 2nd blood draw. Next, participants will be given 90 minutes to use the product ad lib, i.e., as much as desired.
15858498|NCT03974139|Drug|Metformin Oral Tablet|Day 1 to day 3: 500 mg/day Day 4 to day 6: 500 mg/twice a day Day 7 to day 9: 500 mg three times a day Day 10 until next lumbar puncture : 850 mg three times a day
15858499|NCT03974126|Other|40 grams of starch|40 grams of starch in form of white bread to be consumed within 15 minutes
15858500|NCT03974126|Other|80 grams of starch|80 grams of starch in form of white bread to be consumed within 15 minutes
15858501|NCT03974113|Drug|Fitusiran|Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
15858502|NCT03974100|Biological|GP2411|60 mg /mL subcutaneous injection every 6 months
15858503|NCT03974100|Biological|EU authorized Prolia|60 mg /mL subcutaneous injection every 6 months
15858504|NCT03974087|Device|Transcranial Direct Current Stimulation (tDCS)|2mA stimulation for 20 minutes
15858505|NCT03974074|Drug|Albumin infusion|Albumin infusion (20 g, ivgtt, qd) will be performed to patients with HCC after resection in 24 h for three days.
15858506|NCT03974061|Behavioral|Brief Acceptance and Commitment Therapy|Acceptance and Commitment Therapy utilizes mindfulness skills and values-guided behavioral action plans to decrease experiential avoidance and impact a broad array of psychological symptoms.
15858507|NCT03974061|Behavioral|Brief Alcohol Intervention|The Brief Alcohol Intervention is a standard intervention that will be adapted for men and women living with HIV. The intervention will be matched in frequency and length to the brief ACT intervention.
15858547|NCT03973697|Drug|Penn Microbiome Therapy - 001|Fecal Microbiota for Transplant, enema product
15858508|NCT03974048|Diagnostic Test|Blood samples for DNA methylation analysis|DNA from blood samples will be isolated and analyzed for genome-wide DNA methylation patterns using the Infinium HumanMethylationEPIC BeadChip (Illumina, San Diego, CA, USA).
15858509|NCT03974035|Drug|Second infiltration pre-extubation with ropivacaine|The surgeon will proceed firstly with pre-incisional infiltration with lidocaine and adrenaline after intubation, and secondly with pre-extubation infiltration with ropivacaine at the intraoral and intranasal submucosal level in the maxilla and jaw to block the terminal branches of the maxillary and mandibular nerve
15858510|NCT03974022|Drug|DZD9008|Daily dose of DZD9008, except for cycle 0 of Part A, in which a single dose of DZD9008 is administrated. Starting dose of DZD9008 is 50 mg once daily. If tolerated, subsequent cohorts will test increasing doses of DZD9008.
15858511|NCT03974009|Other|Calcaneal taping|Calcaneal taping will be given in long sitting position foot out of the edge.BSN Medical Leukotape P Sports Tape (3.8cm×137m,1.5inch× 15yds) on focusing the calcaneus with the aim of choosing dorsiflexion with eversion. First strap of tape will be applied below the medial malleolus,stretch towards lateral malleolus on affected side. Second strap of tape will be applied repetitively placing the first strap,another will be applied to fix the small tapes.
15858512|NCT03974009|Other|Sham taping|Sham taping will be given to the control group patients.Simple clinical tape will be applied on calcaneus without stretch.It will be applied for 3 days/week for 4 weeks.
15858513|NCT03974009|Other|Conventional therapy|Balance activities (Forward, backward and sideways walking in between 2 parallel lines;Ball kicking against wall(reducing upper limb support)to raising the distance from the wall, kicking to the fixed target; Obstacle walking and Strengthening exercises (Sit to Stand from several heights of chair, Forward & backward and sideward stepping onto blocks of several heights. Each acitivity will be given for 5 minutes.
15858514|NCT03973996|Dietary Supplement|Green Tea Extract|A gummy confection with catechin-rich green tea extract (1 g/d)
15858515|NCT03973996|Dietary Supplement|Placebo|A matched gummy confection formulated without green tea extract
15858516|NCT03973983|Procedure|Ultrasound-guided transgluteal pudendal nerve injection (TG-PNI)|Ultrasound-guided transgluteal pudendal nerve local anesthetic injections
15858517|NCT03973983|Procedure|Finger-guided transvaginal pudendal nerve injection (TV-PNI)|Finger-guided transvaginal pudendal nerve local anesthetic injections
15858518|NCT03973957|Device|Indwelling pleural catheter placement|Indwelling pleural catheter placement by interventional pulmonologist
15858519|NCT03973957|Drug|Fentanyl Citrate|Administration of intravenous fentanyl prior to talc slurry instillation in order to avoid pain associated with talc slurry application
15858520|NCT03973957|Drug|Talc Slurry|Administration of 5 grams of medical grade sterile talc mixed in 50 milliliters of normal saline solution via indwelling pleural catheter for purposes of talc slurry pleurodesis
15858521|NCT03973957|Device|Drainage collection bag|Attachment of one-way Heimlich valve with drainage collection bag circuit to indwelling pleural catheter after talc slurry application for purposes of drainage and pleurodesis in the outpatient setting rather than the inpatient setting.
15858522|NCT03973944|Device|Cardiac resynchronization therapy|Atrio-biventricular pacing to shorten the prolonged PR interval
15858523|NCT03973931|Behavioral|Nudge|Interventions will include a variety of text messages aimed at improving medication adherence.
15858524|NCT03973918|Drug|Encorafenib|450mg QD 28 day cycle
15858525|NCT03973918|Drug|Binimetinib|45mg BID 28 day cycle
15858526|NCT03973918|Biological|Research Bloods|Baseline; pre-cycle 3; Pre-cycle 7; off Treatment
15858527|NCT03973918|Biological|Tumor Tissue|at time of surgery contrast enhancing and non enhancing tumor; 20 unstained slides
15858528|NCT03973905|Other|Not applicable / dataset analysis|Not applicable / dataset analysis
15858529|NCT03973892|Diagnostic Test|Cere|Magnetic Rseonance imaging for brain tumour follow-up
15858530|NCT03973879|Biological|PVSRIPO|Oncolytic polio/rhinovirus recombinant
15858531|NCT03973879|Drug|Atezolizumab|Antibody
15858532|NCT03973866|Device|Alfapump|Implantation of alfapump
15858533|NCT03973853|Behavioral|Virtual reality driving stimulation program|This group will benefit of 14 one hour sessions, using the driving simulator. The program is based on a progressive training, focused on the remediation of the cognitive functions specific to driving. The tool and the type of training aim to help transfer the abilities to daily life.
15858534|NCT03973853|Behavioral|TAU|This group will carry on their usual treatment during the whole length of the study. Patients will be randomized into the 2 groups. This TAU group will be the control group and will help assess the effectiveness of the stimulation program. The stimulation sessions will be proposed to the TAU group at the end of study.
15858535|NCT03973840|Drug|Testosterone Undecanoate|dose was given orally and allowed to reach steady state
15858536|NCT03973827|Drug|ProTrans|ProTrans is an pooled allogenic mesenchymal stromal cell treatment
15858537|NCT03973814|Device|Thermax Blood Warmer|Patients will be their own controls: Prior to-, during-, and after Thermax blood warming.
15858538|NCT03973801|Other|Auricular acupuncture|National Acupuncture Detoxification Association (NADA) protocol for auricular acupressure will be initiated within 24 hours of delivery and continued until withdrawal symptoms measure 6 or less for 12 hours on the modified Finnegan score and/or the morning of expected discharge as in line with standard of care.
15858539|NCT03973788|Procedure|repetitive transcranial magnetic stimulation (rTMS)|A single section of rTMS (2,000 pulses)
15858540|NCT03973775|Drug|Permethrin Cream 5%|Patients will be assigned to the test product Permethrin Cream 5% to the Reference Listed Drug Product Elimite cream.
15858541|NCT03973762|Device|DR Grading with CAD|A CAD system is used to make DR grading.
15858542|NCT03973762|Other|DR Grading by expert panel|DR Grading by expert panel
15858543|NCT03973749|Other|Low salycilate diet|Each arm of the experimental group will be exposed to low and high concentrations of dietary salycilates and urinary LTE4, FEV1, FVC, FEV1/FVC and total inspiratory nasal resistance will be measured at basal level and then two hours after each of the 3 daily meals.
15858544|NCT03973736|Other|application of a diagnostic and therapeutic protocol (multidisciplinary discussion and radiological CT review)|Since the introduction of the new protocol in 2012, a single central multidisciplinary team has been formalized, with weekly discussion of cases, including different specialists from all the provincial hospitals. CT scans of discussed cases are reviewed by one of two experienced radiologists based on pre-defined criteria.
15858548|NCT03973697|Drug|Penn Microbiome Therapy - 002|Fecal Microbiota for Transplant, suspension product
15858549|NCT03973697|Drug|Penn Microbiome Therapy - 003|Fecal Microbiota for Transplant, capsule product
15858550|NCT03973684|Device|pdt experimental group|"G1-40 patients Photodynamic therapy with methylene blue as photosensitizer
~device irradiation with low intensity laser (wave length = 660 nm) 9J (Jaules) per point(6 points) and radiant 90 seconds PS will be applied in sufficient quantity to cover the middle third and back of the tongue and wait for 5 minutes.six points with the distances of 1 cm between them will be irradiated."
15858551|NCT03973684|Other|tongue scraper group|Tongue scrapping will be performed by the same operator in all patients. Posterior -anterior movements will be performed with the scrapper over the lingual dorsum. in order to promote the mechanical removal of tongue coating
15858552|NCT03973658|Device|Hearing aids|Fitting of hearing aids (for the first time)
15858553|NCT03973645|Other|Patient presenting peritonitis managed with fungal research during year 2016|Patient presenting a peritoneal fungal with panfungal PCR and BDG compared to Peritonitis score (PS) and microbiological (ED direct fungal examination)
15858554|NCT03973632|Drug|SH-1028 Tablets|200mg of SH-1028 Tablets, orally once every cycle.
15858555|NCT03973619|Procedure|Labial Graft|As replacement of the damaged urethral tissue, we used a buccal mucosa graft (labial graft).
15858556|NCT03973619|Procedure|Jugal Graft|As replacement of the damaged urethral tissue, we used a buccal mucosa graft(inner cheek - jugal graft).
15858557|NCT03973606|Other|Heath literacy assessment in Arab women in East Jerusalem|A 4-sessions intervention to increase the participant's self-efficacy when interacting with their physician and increase their cardiovascular health knowledge.
15858559|NCT03973580|Behavioral|Attentional Bias Modification (ABM) task|Participants will be presented with a fixation cross (500ms) followed by a pair of identity-matched, angry-neutral faces (1000ms). The pair presentation is replaced by a single arrow-probe (1000ms) in the position of the neural face. Inter-trial intervals (ITI) are 500ms. Participants indicate arrow direction (left or right) by pressing one of two buttons as quickly as possible. By responding to the probe that always replaces the neutral face, participants learn to attend to the non-threat cues and away from threat cues. There are 120 trials of angry-neutral faces in total, and 40 other catch trials with neutral-neutral faces.
15858560|NCT03973580|Behavioral|Control task|The control task is identical with the ABM task, except that in the 120 angry-neutral trials, the arrow-probe replaces the angry face and the neutral face with equal probabilities (60 trials each).
15858561|NCT03973567|Drug|selective serotonin reuptake inhibitor (SSRI) or serotonin noradrenaline reuptake inhibitor (SNRI) antidepressants|On the basis of routine treatment for 8-12 weeks, according to the characteristics of symptoms, a combination of SSRI or SNRI antidepressant drugs was given for 12 weeks.
15858562|NCT03973567|Other|conventional therapy|Anti-HP, acid suppression, gastrointestinal motility regulation, etc.
15858563|NCT03973554|Other|pearl powder|natural product, support bone and joint health
15858564|NCT03973554|Drug|CPP-ACP|Remineralising sugar free dental topical crème, containing bio-available calcium and phosphate
15858565|NCT03973541|Behavioral|Cognitive Behavioral Therapy with Exposure therapy|Treatment will be conducted for 10 consecutive weekly 60 min sessions. In the first two treatment conditions sessions are scheduled as follows: Session one: Building a therapeutic alliance and psycho-education about social anxiety and safety and avoidance behaviors. Session two to four: Cognitive restructuring. Session five to nine: Exposure in either in vivo or VR. Session 10: Relapse prevention. Sessions one to four and ten are identical in the two of three treatment arms.
15858566|NCT03973541|Behavioral|Relaxation Therapy|Relaxation Therapy
15858567|NCT03973528|Drug|traditional Chinese medicine: tonifying kidney Wan|traditional Chinese medicine : tonifying kidney Wan
15858568|NCT03973515|Drug|glucokinase activator|PB-201 is a kind of dual and partial GKA
15858569|NCT03973515|Drug|Placebo|Placebo oral tablet
15858570|NCT03973502|Drug|18F-DOPA PET|One hour later all patient will be injected intravenously with 185 MBq (5mCi) 18F-FDOPA. PET emission data acquisition in 3-dimensional mode will be started at 60 minutes after tracer injection for 30 minutes.
15858571|NCT03973489|Behavioral|Magnetic resonance imaging (MRI)|On visits 2 and 3, subjects will undergo a baseline MRI scan approximately 1 hour after the start of each visit followed by drug administration (placebo or MA) and a second scan 1.5 hours after that.
15858572|NCT03973489|Drug|Methamphetamine Hydrochloride Tablets|Study participants will receive an oral dose of methamphetamine hydrochloride on one of two scan days and an identical looking placebo in tablet form on the other scan day. Drug type will be randomized between the two visits. Participants will receive the following doses of methamphetamine hydrochloride in accordance with their weight: if weight is between 50-60 kg, 15 mg dose of methamphetamine hydrochloride will be administered. Similarly, for 60-80 kg, 20 mg dose; 80-100 kg, 25 mg dose; and 100+ kg, 30 mg dose.
15858573|NCT03973489|Drug|Placebo oral tablet|Study participants will receive an oral dose of methamphetamine hydrochloride on one of two scan days and an identical looking placebo in tablet form on the other scan day. Drug type will be randomized between the two visits.
15858574|NCT03973476|Other|Phone care support by midwife|Mothers can call the midwife's telephone every working day from 8 a.m. to 8 p.m.
15858575|NCT03973463|Behavioral|Elastic knee joint movement|Low resistance (7kg and 10kg) elastic band exercise 3 times a week for 12 weeks.Balanced diet reduces oil intake by 1200 calories per day. Maintains 12 weeks.Balanced diet reduces oil intake by 1200 calories per day. Maintains 12 weeks.
15858576|NCT03973450|Other|Registration of familial forms and associated neoplasia|Retrospective registration of associated endocrine and non-endocrine neoplasia and potential familial setting
15858638|NCT03972917|Diagnostic Test|Transvaginal ultrasonographic examination|Evaluation of endometrial thickness; myoma size and volume
15858998|NCT03970265|Diagnostic Test|extraction of ELF and ILF from explanted lung tissue; meropenem concentration in ELF and ILF; ELF on postoperative day 1-5 when bronchoscopy is performed within clinical routine.|Interventions will only be performed on explanted lung tissue ex vivo and on supernatant of bronchoscopy and are therefore non-invasive
15858577|NCT03973437|Device|Artificial inteligence associated ulcerative colitis severity scoring system|Patients in this group go through a flexible colonoscopy under the AI monitoring device. During the withdrawal process, inflammatory lesions are detected by AI-associated scoring system. Pictures are automatically captured and analyzed by the computer. The Mayo ES and UCEIS sores will be calculated and presented on a second screen, providing a reference for the physician to evaluate the disease severity and mucosal healing stage of the patient. Biopsies will be taken from inflammatory region for histological examination. Videos will be recorded and re-evaluated by a group of experts to determine the final Mayo ES and UCEIS scores.
15858578|NCT03973437|Device|Conventional human scoring|Patients in this group go through a conventional colonoscopy without the AI monitoring device. During the withdrawal process, physician evaluates the disease severity and mucosal healing stage of the patient according to his personal experience. Biopsies will be taken from inflammatory region for histological examination. Videos will be recorded and re-evaluated by a group of experts to determine the final Mayo ES and UCEIS scores.
15858579|NCT03973424|Behavioral|Simple|Participants have three daily goals (weighing, dietary goal, activity goal), will self-monitor (weigh on Wi-Fi enabled scale, use a simplified form of tracking only high-calorie, high-fat foods in the study smartphone app, wear Fitbit activity tracker), will receive 4-5 tailored text messages each week, and will view weekly tailored feedback and lessons in smartphone app.
15858580|NCT03973424|Behavioral|Standard|Participants have three daily goals (weighing, dietary goal, activity goal), will self-monitor (weigh on Wi-Fi enabled scale, track calorie intake, wear Fitbit activity tracker), will receive 4-5 tailored text messages each week, and will view weekly tailored feedback and lessons in smartphone app.
15858581|NCT03973411|Drug|Prophylactic ondansetron|Pacients will receibe prophylactic ondansetron plus standard spinal anesthesia
15858582|NCT03973411|Drug|Placebo|Pacients will receibe standard spinal anesthesia
15858583|NCT03973398|Procedure|Quadratus Lumborum block|ultrasound guided Quadratus Lumborum block for postoperative pain
15858584|NCT03973385|Device|Cryotherapy|patients recieving cryotherapy for skin anesthesia for artérial blood gas
15858585|NCT03973359|Behavioral|Hygienic recommendations|Recommendation of protective behaviours such as frequent hand washing and avoiding risky behaviours such as kissing young children on the mouth or cheeks and sharing utensils, foods etc.
15858586|NCT03973346|Other|Risk screening tool exposure|Risk screening tool is available to providers
15858587|NCT03973333|Drug|IMC-C103C|Weekly IV infusions
15858588|NCT03973333|Drug|Atezolizumab|Q3W
15858589|NCT03973320|Other|Chart Review|This is a chart review to determine if hypotensive neuraxial anesthesia is associated with worse outcomes in Primary Total Hip Arthroplasty patients.
15858590|NCT03973307|Diagnostic Test|UroX bladder cancer biomarker test|Urine test using novel UroX biomarker test for bladder malignancy
15858591|NCT03973294|Device|EIT-measurement|"The use of electrical impedance tomography (EIT) (SentecTom BB2, Landquart, Switzerland) allows the investigators to obtain a visual and quantitative representation of the areas of ventilation and aeration of the lung. The fundamental principle of lung EIT relies on the application of small alternating electrical currents into the thorax and voltage measurements using electrodes on the skin surface generating cross-sectional images representing impedance change in a slice of the thorax. It is a radiation-free imaging method which has the advantage to reveal real-time information.
~An array of electrodes (textile belt with 32 integrated electrocardiographic electrodes) has to be placed around the thorax to inject currents and to measure the resulting voltages on the thoracic surface."
15858592|NCT03973281|Device|Materna Prep Device|Materna Prep Device
15858593|NCT03973281|Other|Standard of Care (SOC)|Standard of Care (SCO)
15858594|NCT03973268|Drug|Ketamine|Arm 1,2, 3 Interventions
15858595|NCT03973268|Drug|Perampanel|Arm 1 and 2 Interventions
15858596|NCT03973268|Other|Placebo|Arm 2 Interventions
15858597|NCT03973268|Device|MagPro 100 TMS Therapy System|Arm 1, 2, 3 Interventions
15858598|NCT03973255|Behavioral|Rehabilitation|Posturography, Whole body vibration
15858599|NCT03973242|Device|Dual focus with narrow band imaging|dual focus mode for imaging magnification + narrow band imaging for the enhancement of mucosal vascularity and irregularity
15858600|NCT03973229|Drug|Estradiol patch|Estradiol (E2) patches at a dose of 100ug will be applied 24-48 hours before the MRI scan is performed.
15858601|NCT03973229|Other|Placebo patch|Placebo patch identical to the estradiol patch will be applied 24-48 hours before the MRI scan is performed.
15858602|NCT03973216|Behavioral|A primary care group-based therapeutic yoga program|The intervention includes therapeutic yoga training and education sessions on benefits of yoga and effects of stress on the body.
15858603|NCT03973203|Dietary Supplement|Niacin|The dose for a slow-released form of niacin will be 750-1000 mg/day. The daily niacin dose, 250 mg/day, is gradually escalated by 250 mg/month so that the full dose is reached after 3 months. The intervention time with the full niacin dose is 1 and 7 months for controls and patients, respectively, and subsequently total intervention time 4 and 10 months, respectively. At the end of the study, the daily dose will be decreased by 250 mg/month rate.
15858604|NCT03973190|Procedure|Immediate alveolar regeneration after exodontia|The extractions will be performed under local anesthesia, without making a mucoperiosteal flap, making an intraassucular incision and using appropriate periotomes, elevators and forcépes, minimizing the surgical trauma of surrounding tissues. Thorough curettage of the alveolus will be performed at the time of extraction to ensure removal of all granulation tissue and stimulate bleeding from the bone base, to form blood clot and promote healing. The sutures will be removed after 7 days of surgery, except for patients in group 3, in which sutures will not be made.
15858605|NCT03973190|Procedure|installation of dental implant and collection of biological material|The material was collected for histological analysis, extracted with trephine drill of 2.0 mm in diameter. Samples were removed before the incision. A linear incision was then made on the alveolar ridge in the region and flap detachment. The initial insertion of the implant was performed using the contra-angle at 30 rpm, the final insertion of the implant was performed with manual torque wrench, where the insertion torque was measured and the value was tabulated, not exceeding 60 N. cm. The component was installed with a maximum torque of 20 N and SmartPeg® (Integration Diagnostics AB, Göteborg, Sweden) was adapted. The prosthetic component was installed with a maximum torque of 20 N and SmartPeg® (Integration Diagnostics AB, Göteborg, Sweden) was adapted. the tabulated values and the incision was sutured.
15858606|NCT03973190|Device|ISQ analysis|The prosthetic component already installed. On it is adapted the SmartPeg® (Integration Diagnostics AB, Göteborg, Sweden). According to the manufacturer, the device generates a series of signals with different frequencies in Hertz (Hz) and these values are immediately converted to ISQ (Implantation Stability Coefficient), providing fast and accurate monitoring. The calibration is performed on the buccal and palatal surfaces of the intermediaries, that is, each implant was submitted to 2 readings. The readings were captured and tabulated for further analysis. were repeated at intervals of 7 to 10 days, 30 days and 60 days, for evaluation of SSI in the period of osseointegration. With the objective of not subjecting the implant to torque and torque during this period and to avoid interfering with the osseointegration process, the micro-pillars were covered with the micro-pillar protection screws with digital pressure only.
15858607|NCT03973177|Drug|Phenol Injection|6% aqueous phenol 2.5 mL will be mixed with 0.5 mL iopamidol 300 and will be injected at each target site with live, pulsed fluoroscopy (5-8 seconds at each location) to observe the contrast dye-tagged phenol covering the lateral margin of the femur or tibia respectively on AP and lateral views. The needles will then be removed and band-aids placed.
15858608|NCT03973177|Drug|Methylprednisolone Injection|Methylprednisolone acetate 10 mg with 2 mL preservative saline and 0.5 mL iopamidol 300 will be injected at each of the 3 target sites with live, pulsed fluoroscopy (5-8 seconds at each location) to observe the contrast dye-tagged steroid mixture covering the lateral margin of the femur or tibia respectively on AP and lateral views; the needles will be removed and band-aids placed.
15858609|NCT03973151|Drug|HL-085|HL-085 is one MEK inhibitor.
15858610|NCT03973138|Drug|Ranibizumab|DME patients who were diagnosed through fundus manifestations and FFA examination were treated by intravitreal injections of ranibizumab (0.5mg Lucentis®; Genentech, South San Francisco, CA) under the pro re nata (PRN) treatment regimen. The retreatment were conducted if BCVA was reduced by 0.1 logarithm of the minimal angle of resolution (logMAR) value or more from maximum acuity or if OCT central subfield thickness was more than 300μm.
15858611|NCT03973125|Drug|conbercept|After three monthly injections of conbercept, if no effects was seen in the patients, the patients will receive rescue treatments such as photodynamic therapy (in the macular) or laser photocoagulation (outside the macular).
15858612|NCT03973112|Drug|HLX10+HLX04|HLX10 developed by our company is sterile intravenous injection, with specification of 100 mg/10 mL/bottle. The main ingredient is 10.0 mg/mL of recombinant humanized anti-PD-1 monoclonal antibody. HLX04 is an anti-tumor angiogenesis drug, which is a biosimilar drug bevacizumab designed and developed by Shanghai fuhonghanlin biotechnology co., ltd. based on the protein sequence of Avastin® by Roche pharmaceutical company.
15858613|NCT03973099|Dietary Supplement|PM011|PM011 is a 400 mg hard gelatin capsule containing water extracts of Nelumbinis Semen. The sprayed-dry extract of the herbal medicine used was purchased from Sun Ten pharmaceutical company in Taiwan. Each participant received twelve capsules of PM011, which divided into 2.4 g treatment or 4.8 g treatment group or placebo daily for two weeks and was instructed to take six capsules after breakfast and six capsules after dinner. Subjects in the placebo group received the equivalent amount of starch and lactose mixture capsules and administered with the same schedule.
15858614|NCT03973086|Dietary Supplement|Citrus flavonone-O-glycosides- LD|Low Dose of 200 mg
15858615|NCT03973086|Dietary Supplement|Citrus flavonone-O-glycosides- HD|High Dose of 400 mg
15858616|NCT03973086|Dietary Supplement|Placebo|Placebo (Microcrystalline Cellulose) of 400 mg
15858617|NCT03973073|Combination Product|CapulinTM|camouflage
15858618|NCT03973073|Other|topical applications and NB-UVB|combination therapy of vitiligo
15858619|NCT03973060|Device|Concentric-eccentric muscular work|For muscular contraction, the physiotherapist carried out 12 repetitions with one minute rest between series and series, total working time of 12 minutes.
15858620|NCT03973060|Genetic|Genetic polymorphism|Genetic polymorphism study by Polymerase Chain Reaction (PCR) to determine whether the genetic makeup of individuals for the improvement of muscular work in the results of the study.
15858621|NCT03973047|Drug|Bremelanotide|Sterile aqueous solution for injection, provided as an autoinjector pen
15858622|NCT03973047|Drug|Zofran|8 mg tablet (over-encapsulation in a capsule)
15858623|NCT03973047|Drug|Placebo|capsule
15858624|NCT03973034|Diagnostic Test|Low depth whole genome sequencing|Low depth whole genome sequencing of the peripheral blood samples from different groups.
15858625|NCT03973021|Biological|Very small embryonic-like stem cell(VSEL)|Mononuclear cells were collected from peripheral blood of each patient using a machine, VSELs were isolated, and each group was injected according to different numbers after activation
15858626|NCT03973008|Radiation|Adjuvant Chemoradiotherapy|DT 45Gy/25F/5W, using IMRT technology, synchronous tegio single drug chemotherapy
15858627|NCT03973008|Drug|Adjuvant Chemotherapy|Oxalis 130mg/m2 intravenous drip on day 1, tegio 80-120 mg daily, twice, half an hour after breakfast and dinner, for 14 consecutive days
15858628|NCT03972982|Drug|Simplified intensive insulin therapy regimen|Short-term continuous subcutaneous insulin infusion to maitain near normoglycemica for 1 week, thereafter basal insulin and metformin were subsequently used. Wearable devices and smart apps will be used for lifestyle modification.
15858629|NCT03972982|Drug|Traditional Short-term Intensive insulin therapy|Short-term continuous subcutaneous insulin infusion will be initiate to maitain near normoglycemica for 2 weeks, then patients will be ordinarily follow-up
15858630|NCT03972969|Behavioral|Facility-based structured exercise|Structured exercise program in a facility with instruction and encouragement
15858631|NCT03972969|Behavioral|Home-based structured exercise|Structured exercise program in the home with instruction and encouragement
15858632|NCT03972969|Behavioral|Health education|Provision of general information about a variety of topics
15858633|NCT03972956|Other|No intervention will be given to patients.|Samples are collected at the time of a scheduled surgery that is part of normal treatment. This study will not have any impact on the care or treatment the patient receives.
15858634|NCT03972943|Procedure|Continuous Positive Airway Pressure|Receive CPAP treatment
15858635|NCT03972943|Other|Patient Observation|Undergo observation
15858636|NCT03972943|Other|Questionnaire Administration|Ancillary studies
15858637|NCT03972930|Radiation|Hypofractionated Radiotherapy|Hypofractionated radiation is delivered using highly conformal technique, allowing for a high dose of radiation to be delivered precisely.
15858639|NCT03972904|Dietary Supplement|Light-Fat Rice® combined with Active Peptide®+ lifestyle guidance|Subjects will be given the Light-Fat Rice® combined with Active Peptide® with a lifestyle guidance to assist diabetes management. The method of taking the product has two parts: 1.Light-Fat Rice®: 80g (1 pack) per day as a staple meal replacement, used as a separate staple food or mixed with other staple foods, taking 4 weeks; 2.Active Peptide®: 20g (2 packs) per day (1 pack each morning and evening), served with 300ml of 40°C warm water each time before meals and take it for 4 weeks.
15858640|NCT03972904|Dietary Supplement|A staple food of comparable energy containing a small amount of dietary fiber combined with a comparable energy maltodextrin + lifestyle guidance|A staple food of comparable energy containing a small amount of dietary fiber combined with a comparable energy maltodextrin (both produced by the same manufacturer) with a lifestyle guidance will be given by the professional to assist in diabetes management. The product is taken as follows: 1.equal-energy staple food containing a small amount of dietary fiber: 80g (1 pack) per day, used as an independent staple food or mixed with other staple foods, taking for 4 weeks; 2.equal-energy maltodextrin: 20g(2 packs) per day(1 pack each morning and evening),take it with 300ml of 40°C warm water for 4 weeks.
15858641|NCT03972891|Other|intervention break of 12 weeks|"The intervention of this study is a break of the intervention for 12 weeks under the following conditions:
~no therapeutic intervention during the break
~no language-specific specific exercises
~language-specific strategies in everyday life can be applied, e.g. modeling techniques"
15858642|NCT03972878|Other|control snack|dry fruit snack (200 kcal) + 250 ml water
15858643|NCT03972878|Other|control cream|commercial spreadable cocoa and hazelnut cream (200 kcal)+ 250 ml water
15858644|NCT03972878|Other|cream version 1|commercial spreadable cocoa and hazelnut cream (200 kcal), version 1+ 250 ml water
15858645|NCT03972878|Other|cream version 2|commercial spreadable cocoa and hazelnut cream (200 kcal), version 2+ 250 ml water
15858646|NCT03972878|Other|cream version 3|commercial spreadable cocoa and hazelnut cream (200 kcal), version 3+ 250 ml water
15858647|NCT03972878|Other|control chocolate bar|commercial chocolate bar (200 kcal)+ 250 ml water
15858648|NCT03972878|Other|chocolate bar version 1|commercial chocolate bar (200 kcal), version 1+ 250 ml water
15858649|NCT03972865|Other|EmbrunMan race|The EmbrunMan is a long-duration triathlon including 3.8 km of swimming, 188 km of cycling and 42.2 km of running, with a cumulative vertical drop of 4000 metres. Duration of the race varies between 10 hours and 16hours depending on the athletes' performance.
15858650|NCT03972826|Other|Provodine|Subjects serve as self-controls. Subjects first perform hand-hygiene with alcohol-based hand rub then doff gloves contaminated with either S. marcescens or MS2 phage and the hands are cultured using a bag-broth method to determine whether the subjects self-contaminated while doffing. Subjects then clean their hands thoroughly, perform hand hygiene with Provodine, then repeat the doffing and culture process.
15858651|NCT03972813|Behavioral|Broadened information about cancers|Caregivers receive information that HPV causes more than just cervical cancer.
15858652|NCT03972813|Behavioral|Information about STDs|Caregivers learn that HPV is an STD.
15858653|NCT03972813|Behavioral|Information about infectious disease|Caregivers learn that HPV is infectious (but information that it is an STD is omitted).
15858654|NCT03972813|Behavioral|Recommendation for children 12 years old|Caregivers are prompted to get their child vaccinated when the child is 12 years old.
15858655|NCT03972813|Behavioral|Recommendation for children 18 years old|Caregivers are prompted to get their child vaccinated when the child is 18 years old.
15858656|NCT03972813|Behavioral|Standard age information|Caregivers are given information about when the HPV vaccination can be given in China, but no additional recommendations.
15858657|NCT03972813|Behavioral|Cervical cancer|Caregivers are told that HPV causes cervical cancer.
15858658|NCT03972813|Behavioral|Blank information about communicability|Caregivers are not given any information on how HPV is spread.
15858659|NCT03972787|Device|Proactive social robot|ElliQ, is a new type of robotic technology aimed at reducing loneliness and social isolation in older adults. It differs from other social/companion robots on the market, as it leverages artificial intelligence to create personalized and interactive experiences for the user, while also proactively offering prompts (such as reminding the user to stay hydrated) and suggesting and initiating various activities for the user (such as offering to play a game). This social companion adapts to the personalities and interests of the older adult, creating a personalized experience and recommending content the user may enjoy such as news, music, TED talks, and cognitive games.
15858660|NCT03972774|Diagnostic Test|PET Stress Test|Cardiac positron emission tomography (PET)/computed tomography (CT) and test-result dependent management
15858661|NCT03972774|Other|Non-PET Medical Management|Appropriate medical management without cardiac PET stress-imaging
15858662|NCT03972761|Device|Magnetic Resonance Imaging (MRI) 3 tesla|Functional neuroimaging objectifies the activation of specific areas of the brain
15858663|NCT03972748|Drug|Itraconazole 200 mg|Oral Itraconazole capsules, 200 mg, twice daily, for 60 days prior to surgery with curative intent.
15858664|NCT03972735|Other|Psychiatric interview|PANSS, MADRS, PSP, YMRS
15858665|NCT03972735|Other|Clinical, diagnostic and functional evaluation|ISMI, STORI, SERS, S-QOL, WEWMBS, BIRCHWOOD, MARS
15858666|NCT03972735|Other|neuropsychological assessment|WAIS IV, BEM 144, TMT A, TMT B, D2-R, V-LIS
15858667|NCT03972735|Other|NECT PROGRAM|Narrative Development and Cognitive Therapy (NECT) is a 12 session group-based manualized intervention combining psychoeducation, cognitive restructuring and narrative enhancement. The 2h sessions are conducted by two trained facilitators.
15858668|NCT03972722|Drug|GLS-010|Patients will be given 240mg GLS-010 every treatment.
15858669|NCT03972709|Drug|RG6147|Intravitreal (ITV) injections of RG6147
15858670|NCT03972709|Drug|Sham Control|ITV injections of Sham Control
15858671|NCT03972696|Radiation|Irradiation|BA3S versus BA2 irradiation of lymphatic node areas, administered using a lineal accelerator, after 3D delimitation of the supraclavicular and axillary levels I, II and III. In both treatment arms, further tumoral bed boost will be allowed according to the investigator criteria, whether dose contribution to the nodal areas can be calculated. Due to its nature, interventions cannot be asked.
15858822|NCT03971526|Other|MRI images review|MR images were reviewed by one junior radiologist and one senior neuroradiologist, both blinded to clinical, therapeutic and follow-up data.
15858672|NCT03972683|Other|Handgrip Exercise Training|Signaling mechanisms that regulate blood flow will be studied before and after 7 weeks of handgrip exercise training with the non-dominant forearm. Training sessions will consist of 30 min of rhythmic contractions using a handgrip exercise device, and participants will complete four training sessions per week.
15858673|NCT03972683|Drug|Acetylcholine|Vasodilatory sensitivity to acetylcholine will be assessed in dose-response fashion as a standard test of vascular function. Doses of 0.5, 1.5, and 15 μg/dl forearm volume/min will be infused via a brachial artery catheter for 4 min per dose.
15858674|NCT03972683|Drug|Adenosine Triphosphate|Vasodilatory sensitivity to adenosine triphosphate will be assessed during infusion of a dose of 10 μg/dl forearm volume/min administered via a brachial artery catheter over a total of 4 min.
15858675|NCT03972683|Drug|Atropine|Atropine will be used to inhibit muscarinic acetylcholine receptors in order to determine the contribution of acetylcholine to vasodilation during exercise. An initial dose of 0.2 mg will be infused via a brachial artery catheter over 3 min, then a maintenance dose of 0.067 mg will be infused over 1 min prior to each of 5 subsequent experimental trials.
15858676|NCT03972683|Drug|Phenylephrine|Vasoconstriction to phenylephrine will be used to assess sensitivity to alpha 1 adrenergic stimulation. Phenylephrine will be infused via a brachial artery catheter at 0.125 or 0.25 μg/dl forearm volume/min (18-35 and 60-85 age groups, respectively), adjusted according to forearm blood flow, for a total of 16 min.
15858677|NCT03972683|Drug|Sodium Nitroprusside|Sodium nitroprusside will be infused via a brachial artery catheter as a control vasodilator to elevate resting forearm blood flow to a level similar to that during exercise. The dose will be adjusted to match forearm blood flow to a similar level as during handgrip exercise, with an anticipated average dose of 1 μg/dl forearm volume/min. The dose will be infused for a total of 14 min.
15858678|NCT03972657|Drug|REGN5678|Administered at the assigned dose level (DL) by intravenous (IV) infusion or subcutaneous (SC) administration once weekly (QW) to every three weeks (Q3W)
15858679|NCT03972657|Drug|Cemiplimab|Administered at the assigned DL by intravenous (IV) infusion Q3W
15858680|NCT03972657|Other|18F-DCFPyL|PSMA PET/CT imaging agent to be used at select sites
15858681|NCT03972644|Procedure|Aortic valve replacement|Open heart surgery or transcatheter surgery
15858682|NCT03972631|Behavioral|Lifestyle education|Lifestyle education include the diet principles, physical activity guideline and behavioral strategies.
15858683|NCT03972631|Behavioral|Intensive lifestyle intervention|One to one intensive lifestyle intervention according to the diet and activity plan
15858684|NCT03972631|Behavioral|Hypocaloric low-carbohydrate diet plan|A diet plan with restricted calorie and carbohydrate intake
15858685|NCT03972618|Behavioral|Installation of water filtration system for filtering existing water source|Installation of water filtration system and education on hand washing.
15858686|NCT03972605|Device|Reading of Automated Breast Ultrasound in conjunction with Screening Mammography|Reader performance when SoftVue automated breast ultrasound (SV) and digital screening mammography (DM) are combined, compared to screening mammography alone.
15858687|NCT03972592|Drug|Topical 0.1% Sirolimus|The formulation is 0.03 g rapamycin, 1.5 g Transcutol, Quantum Satis (QS) 30g Excipial® hydrocream, corresponding to a concentration at 0.1%. The cream will be packaged in 30 ml aluminium tubes.
15858688|NCT03972592|Drug|Topical Vehicle|The same vehicle than the one used in the topical 0.1% sirolimus preparation will be used for the other half area of CMLM, i.e. Excipial® hydrocream. It will be packaged to maintain the double blind way of this trial and will be undistinguishable from the sirolimus cream.
15858689|NCT03972579|Behavioral|Graded exposure therapy|Gradually increased contact with avoided sensory stimuli (e.g., light, noise, movement) and activities (e.g., mental exertion, physical exercise, stressful activities) in order to increase tolerance.
15858690|NCT03972579|Behavioral|Pacing + mindfulness|Shifting from symptom-contingent to time-contingent activity stopping rules, minimizing activity level peaks (excessive endurance behavior) and valleys (prolonged periods of recuperative rest) to improve overall functioning.
15858691|NCT03972566|Drug|INOMAX|INOMAX + PBM
15858692|NCT03972553|Procedure|Sugarbaker technique for repairing parastomal hernia|The bowel will be brought through the peritoneum lateral to the edge of the retromuscular mesh and then draped over the mesh before bringing it through the anterior fascia medially.
15858693|NCT03972553|Procedure|Keyhole technique for repairing parastomal hernia|The bowel will be brought through defects in the posterior rectus sheath or contiguous peritoneum, mesh, and anterior fascia.
15858694|NCT03972540|Behavioral|Mindful eating intervention|A Mindful Eating Workshop™ workbook was used for standardization and reproducibility of these sessions. The group sessions were focused on teaching applied strategies to consume food with intention and attention and aimed at improving emotional relationships with food. Intervention sessions were held once a week in the evening for 2 hours per session over 8 weeks. The intervention was delivered in a large conference room on the University of Georgia campus. Participants were required to attend seven out of eight sessions. If participants missed a session, they met with the instructor 30 minutes before the beginning of the following week's session to receive individual instruction on content of the missed session.
15858695|NCT03972527|Device|Photobiomodulation|Provide photobiomodulation therapy to subjects prior to each radiation therapy session.
15858696|NCT03972527|Other|Routine Oral Care and Analgesia|Standard oral care, oral hygiene and oral pain protocols
15858697|NCT03972501|Drug|AZR-MD-001 Vehicle|AZR-MD-001 is an ophthalmic ointment
15858698|NCT03972501|Drug|AZR-MD-001 Active Dose|AZR-MD-001 is an ophthalmic ointment
15858702|NCT03972462|Drug|NPC-12G Gel 0.2%|Period 1
15858703|NCT03972462|Drug|Rapamune® 2 mg tablet|Period 2
15858704|NCT03972449|Behavioral|BEAT-Speech|BEAT-Speech integrates beatboxing techniques within speech-therapy services for individuals with speech sound disorders.
15858999|NCT03970252|Drug|Fluorouracil|Given IV
15859000|NCT03970252|Drug|Irinotecan|Given IV
15858705|NCT03972449|Behavioral|Traditional Articulation Approach|The traditional approach to treating speech sound disorders focus on one or two sounds at a time until they are mastered by the client. Perceptual and production training are used with target starting at simple (isolation) and moving to more complex (sentences). A variety of cues such as shaping and phonetic placement cues are used.
15858706|NCT03972423|Other|With or wiyhout a checklist|The evaluation of the impact of the use of this Checklist will be done in comparison with the standard transmission practice
15858707|NCT03972410|Behavioral|EMDR|2-4 sessions individual 60-min-long treatment sessions of EMDR Recent birth trauma protocol
15858708|NCT03972410|Behavioral|SEDP|2-4 sessions individual 60-min-long treatment sessions of SEDP
15858709|NCT03972397|Device|Intercostal Nerve Cryoablation|Patients will receive intraoperative intercostal nerve cryoablation using CryoICE® CRYO2 cryoablation probes (AtriCure, Inc) to intercostal spaces 4th to 10th in thoracoabdominal aortic repairs and 4th to 8th in descending thoracic aortic repair cases prior to wound closure.
15858710|NCT03972397|Drug|Bupivacaine liposomal injectable suspension|Patients from both groups will receive the same volume of diluted Exparel®, which will be given in four 20ml syringes using 22-gauge needles (266mg of liposomal bupivacaine, equivalent of one 1.3% 20ml vial of EXPAREL, diluted in 50ml of preservative-free normal (0.9%) sterile saline for a total volume of 70ml).
15858711|NCT03972397|Drug|Patient-controlled analgesia (PCA)|Patients will have access to the standard PCA (Patient-Controlled Analgesia) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10-minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs.
15858712|NCT03972384|Behavioral|Post-ICU Problem Solving|"We have adapted the Cognitive Orientation to Daily Occupational Performance (CO-OP) as the Post-ICU Problem Solving intervention to be delivered in the home to patients following an illness that required an ICU stay. CO-OP is a form of meta-cognitive strategy training that teaches individuals to identify and prioritize problematic daily activities, identify barriers impeding performance, generate and evaluate strategies addressing these barriers, and generalize learning through practice. Thus, strategy training teaches skills that can be used to address disability in real-life activities, and is integral to personalized rehabilitation services. CO-OP has been adapted in numerous settings and most recently, it is being utilized successfully in patients with acquired cognitive dysfunction following acute stroke. This represents a useful intervention, tested in similar populations with minimal risk to the participants and potential for maximal benefit for this population."
15858713|NCT03972371|Device|The ProVee Urethral Expander System|The ProVee Urethral Expander System is supplied as a single use, sterile device and consists of a nitinol expander implant and custom implant delivery system. The delivery system is designed to allow the implant to be deployed under direct vision.
15858714|NCT03972358|Drug|Mifepristone|All participants will receive 200 mg mifepristone, to be taken orally on day 1.
15858715|NCT03972358|Drug|Misoprostol|All participants will receive 800 mcg misoprostol, to be taken buccally 24 hours after mifepristone (day 2)
15858716|NCT03972345|Drug|Norditropin® FlexPro®|Patients will be treated with commercially available Norditropin® FlexPro® according to routine clinical practice at the discretion of the treating physician. The decision to initiate treatment with commercially available Norditropin® FlexPro® has been made by the treating physician and the patient's parents/legal guardian before and independently of the decision to include the patient in this study.
15858717|NCT03972332|Diagnostic Test|Quantitative Sensory Testing|"PPT: An electronic data collection unit will be used featuring an electronic algometer connected with a laptop where the amount of pressure will be displayed on the screen. When the pressure pain detection threshold is reached (the point where the pressure sensation starts to be experienced as pain), the individual will press a button at a handheld device, that will automatically store the pressure value in the system and serve as an indication, for the examiner, to stop the testing.
~TS: A pinprick stimulator (Weight: 256mNewton) will be used. The examiner will apply the pen that features a retractable blunt needle in a repetitive manner (once per second for ten seconds). The individual will be asked for the intensity of pain (NRS) at the first and at the last time and the given score will be noted.
~CPM: A manual blood pressure sphygmomanometer will be used in conjunction with the electronic algometer described above (PPT)."
15858718|NCT03972319|Dietary Supplement|2 capsules of Concentrated omega-3 triglycerides- fish 1000mg (600mg Eicosapentaenoic acid (EPA), 1400mg Docosahexaenoic acid (DHA)) per day|4 weeks course of Omega-3 (2 capsules of Blackmores Omega Daily Concentrated Fish Oil per day
15858719|NCT03972306|Drug|Ocrelizumab|Administered by subcutaneous Injection
15858720|NCT03972306|Drug|Ocrelizumab|Administered by Intravenous (IV) Injection
15858721|NCT03972306|Drug|rHuPH20|Administered in a 2-mL glass vial as a sterile, single-use, injectable liquid to be manually mixed with SC ocrelizumab
15858722|NCT03972293|Behavioral|Intern Health Study behavioral change mobile notification|The study's mobile app will be used to deliver intervention notifications. The intervention notifications appear on the participant's phone lock screen. The notifications have 3 categories: mood notifications, activity notifications, sleep notifications. Mood notifications aim to increase the participant's mood. Activity notifications aim to increase the participant's physical activity. Sleep notifications aim to increase the participant's sleep duration. To increase the category of interest, the notifications use two types of messages: life insights and tips. Life insights provide participants information on their historical data (for a given category) in order to help them self-monitor. Tips are non-data based notifications which provide general advice for improving the category of interest.
15858723|NCT03972293|Behavioral|Intern Health Study mobile app|The Intern Health Study mobile app is able to conduct a daily mood survey. It also aggregates and visualizes historical data on intern mood, activity, and sleep.
15858724|NCT03972280|Biological|Recombinant anti-granulocyte colony-stimulating factor (G-CSF) receptor monoclonal antibody|Recombinant anti-G-CSF receptor monoclonal antibody is a preservative-free, sterile liquid formulation that is suitable for intravenous infusion
15858725|NCT03972267|Procedure|Free gingival graft|Free Gingival Graft removal from the palate donor area for socket preservation
15858726|NCT03972267|Device|Enamel Matrix Derivate|EMD in contact with the palate wound for 5 min. After this time, palatal area will be covered with an individualized acetate plate which will stay in position for 2 hours after the procedure
15859001|NCT03970252|Drug|Irinotecan Hydrochloride|Given IV
15858727|NCT03972254|Behavioral|Modified Interaction Guidance|The main steps in the procedure are to have the family identify the primary concern they are facing, highlight the strengths that the family already has in place and expand on those strengths, convey/impart caregiving and societal norms, and offer other perspectives (McDonough, 2004). The goal of this therapy is to engage the family to take an active role in the construction of their overall treatment. The individualized treatment approach focuses and builds on existing strengths.
15858728|NCT03972241|Device|foot insole|arch support and toe extension
15858729|NCT03972228|Combination Product|Microdevice loaded with 19 chemotherapeutic agents|The microdevice containing 19 FDA-approved chemotherapeutic agents will be placed in the suspected tumor tissue at the time of surgical resection. Multiple chemotherapeutic agents will passively diffuse into local, confined regions (several microns) of the surrounding microenvironment. The agents are released at approximately one millionth of a systemic dose. The device(s) will be removed for analysis at the time of resection, which will be performed for clinical indications independent of enrollment in this study.
15858730|NCT03972215|Drug|Berberine Chloride|Traditional Chinese Medicine
15858731|NCT03972215|Drug|Placebo|Placebo Control
15858732|NCT03972202|Diagnostic Test|MRI|Brain MRI will be performed (no contrast) to correlate brain anatomy/function with behavioral testing.
15858733|NCT03972202|Device|TMS|Repetitive TMS will be applied to transiently disrupt cerebellar speech pathways.
15858734|NCT03972202|Behavioral|Speech-motor behavioral testing|Language/speaking tasks will be performed during which participants are asked to speak in response to audio/video cues; participants' responses will be recorded. For patients with cerebellar ataxia, additional diagnostic surveys may be completed.
15858735|NCT03972189|Drug|TQ-B3101|TQ-B3101 300 mg given orally in fasting conditions, twice daily in 28-day cycle.
15858736|NCT03972163|Behavioral|NIA Medication Management - Active Comparator|"As the attention control, we will refer staff in control offices to the National Institution on Aging (NIA)'s website on Medicines and Medication Management to review content and materials for use in Family Care Giver (FCG) support."
15858737|NCT03972163|Behavioral|STOPPFrail (Screening Tool of Older Persons Prescriptions)|A screening tool used by clinicians with frail older adults with life-limiting illness to review medications
15858738|NCT03972163|Behavioral|"Discontinuing Medication Appropriately and Understanding the Art of Communication about Deprescribing"|Education resoruce used by clinicians to simplify and align medications with goals of care
15858739|NCT03972163|Behavioral|"Key Approaches to Support Informal Family Caregivers in Managing Medications"|Education resource used by clinicians to support Family Care Givers (FCGs)
15858740|NCT03972150|Drug|BI 836880|Solution for infusion
15858741|NCT03972150|Drug|BI 754091|Solution for infusion
15858742|NCT03972137|Behavioral|Cognitive-Behavioral Smoking Cessation|Participants were provided with six individualized smoking cessation counseling sessions designed to help them prepare to quit, set a quit date, behaviorally manage early abstinence, and to resume cessation upon lapse.
15858743|NCT03972137|Behavioral|Heart Rate Variability Biofeedback (HRVB)|All participants were provided with individualized training in resonance breathing using biofeedback to help improve self-regulation.
15858744|NCT03972137|Drug|Transdermal Nicotine patch|All participants were offered up to eight weeks of transdermal nicotine patch, beginning on their quit date.
15858745|NCT03972124|Drug|CBD 100 mg OD|CBD oil - purified to <1% THC in soft-gel capsules
15858746|NCT03972124|Drug|CBD 200 mg OD|CBD oil - purified to <1% THC in soft-gel capsules
15858747|NCT03972124|Drug|Placebo|Soft-gel capsules containing placebo
15858748|NCT03972111|Drug|TPOXX 200Mg Capsule|TPOXX 600 mg (three 200 mg.) capsules twice daily for 14 days
15858749|NCT03972085|Other|Neural gliding exercises|"Neural gliding exercises: In addition to the Electrotherapy procedure, patients were asked to actively perform knee extension, ankle dorsiflexion and head extension in the slumped posture followed by simultaneous ankle plantar flexion together with knee and head flexion (10 repetitions in 1 minute). Patients performed the exercises under a home-based program for 5 days of the week during a total period of 3 weeks.
~Electrotherapy sessions: Local Hot Pack (30 minutes), Chattanoga™ TENS (20 minutes, 80-180 Hz frequency, 50-100 wavelength) and Chattanoga™ ultrasound (1 Mhz frequency, 3 W/cm2 3 minutes) were applied for 5 days per week during a total period of 3 weeks. Subjects in ETG did not do any other exercise approach."
15858750|NCT03972085|Other|Electrotherapy sessions|Electrotherapy sessions: Local Hot Pack (30 minutes), Chattanoga™ TENS (20 minutes, 80-180 Hz frequency, 50-100 wavelength) and Chattanoga™ ultrasound (1 Mhz frequency, 3 W/cm2 3 minutes) were applied for 5 days per week during a total period of 3 weeks. Subjects in ETG did not do any other exercise approach.
15858751|NCT03972072|Other|Pre-defined MR-linac based IGRT and plan adaptation protocol|daily MR-imaging/MR guided radiotherapy once weekly offline plan adaptation to a total of 6
15858752|NCT03972072|Diagnostic Test|salivary flow measurements|baseline, 6 month-, 12 month- and 24 month-follow up salivary flow measurements and LENT-SOMA subjective/objective evaluation of xerostomia
15858753|NCT03972059|Other|Exercise training - Phase 1|Phase 1 is the first 4 weeks of the 12-week training program.
15858754|NCT03972059|Other|Exercise training - Phase 2|Phase 2 is the next 4 weeks following phase 1 of the 12-week training program. The exercise intensity during exercise bouts in this phase is increased compared to the exercise intensity applied in phase 1.
15858755|NCT03972059|Other|Exercise training - Phase 3|Phase 3 is the last 4 weeks of the 12-week training program. The exercise intensity during exercise bouts in this phase is increased compared to the exercise intensity applied in the previous phases.
15858756|NCT03972046|Drug|Talimogene laherparepvec (T-Vec)|Talimogene laherparepvec (T-Vec) up to 4mL subcutaneous injection
15858757|NCT03972046|Drug|Dabrafenib (BRAF Inhibitor)|Dabrafenib (BRAF Inhibitor) 150 mg by mouth twice a day
15858758|NCT03972046|Drug|Trametinib (MEK Inhibitor)|Trametinib (MEK Inhibitor) 2 mg by mouth once a day
15858759|NCT03972033|Behavioral|EMDR|CBT and EMDR treatments will be provided for 16 weeks. CBT and EMDR comprise 20 individual sessions in 16 weeks and were conducted according to published treatment manuals. Psychotherapy visits are to be scheduled twice a week for weeks 1-4, then once a week for 12 weeks. All treatment sessions will be video-recorded for fidelity rating and supervision. Safety criterion: If a severe worsening of symptoms is observed patients would be withdrawn from their assigned treatment arm.
15859002|NCT03970252|Drug|Leucovorin|Given IV
15858760|NCT03972033|Behavioral|CBT|CBT and EMDR treatments will be provided for 16 weeks. CBT and EMDR comprise 20 individual sessions in 16 weeks and were conducted according to published treatment manuals. Psychotherapy visits are to be scheduled twice a week for weeks 1-4, then once a week for 12 weeks. All treatment sessions will be video-recorded for fidelity rating and supervision. Safety criterion: If a severe worsening of symptoms is observed patients would be withdrawn from their assigned treatment arm.
15858761|NCT03972020|Behavioral|Mindfulness Based Intervention|"The MBI used in this study is called body-affective mindfulness (BAM); BAM is based on:
~(1) awareness practices such as body scan, breath meditation, walking meditation and yoga exercises; (2) mindfulness in relationship practices such as loving kindness, enriching listening to nature and persons and self-compassion; (3) sensorimotor psychotherapy Sensorimotor psychotherapy emphasizes the use of somatic resources to attain and sustain a mindful disposition and integrates the concept of a stress response with the concept of a window of tolerance in order to maximize the clinical utility of the intervention and tailor it to breast cancer patients."
15858762|NCT03972020|Behavioral|Cognitive Behavioral Therapy|Cognitive behavior therapies will include cognitive restructuring, relaxation, skills training, and visual imagery, among other modalities.
15858763|NCT03972007|Device|Fotobiomodulation|A 16x28 cm LED blanket containing 160 LEDs will be used and will use a total energy per area of 60J, with a wavelength of 940nm, just before the muscle fatigue protocol and will be applied throughout the Biceps extension.
15858764|NCT03971994|Behavioral|Facial expression recognition task|We will present emotional expressions to participants. Their task will be to determine which emotion is expressed by each face. Participants' eye movements and brain activity will be recorded while they explore the face.
15858765|NCT03971981|Dietary Supplement|100% Xylitol Gum|Subjects were instructed to consume the gums as they normally would be consumed.
15858766|NCT03971981|Dietary Supplement|22% Xylitol Gum|Subjects were instructed to consume the gums as they normally would be consumed.
15858767|NCT03971968|Procedure|Skin replacement with artificial skin|Integra® Dermal Regeneration Template is a bilayer membrane system for skin replacement. The dermal replacement layer is made of a porous matrix of fibers of cross-linked bovine tendon collagen and glycosaminoglycan (chondroitin-6-sulfate). The epidermal substitute layer is made of thin polysiloxane (silicone) layer to control moisture loss from the wound. The silicone outer layer temporarily closes the wound to ward off infection and control fluid and heat loss. As skin cells migrate into the matrix the collagen is slowly absorbed into the body and replaced with protein that is naturally produced by the skin. In approximately 14 to 21 days, new dermal skin is produced and the silicone layer can be removed. A thin skin graft of the person's epidermis is applied to the wound area to complete the procedure. In total, the two surgical procedures are typically completed within 30 days. A person is left with flexible growing skin and minimal damage at the skin graft donor sites.
15858768|NCT03971955|Other|Mixed Meal Test|a standard liquid mixed meal will be administered to the participant. The test meal with 1 kcal/ml and with the following caloric distribution Protein: 25%, Carbohydrate: 53%, Fat: 22% is given at a dose of 6 mL per kilogram body weight. Maximum dose is 360 mL and it will be ingested over 5 minutes. Blood samples will be taken 10 min prior to ingestion (t=-10), at baseline (t = 0), and at 15, 30, 60, 90, and 120 minutes.
15858769|NCT03971955|Other|Dual Energy X-Ray Absorptiometry (DEXA)|DEXA Scans will be performed to obtain body composition measures (body fat and estimated muscle mass) using a General Electric (GE) Lunar iDXA whole-body scanner.
15858770|NCT03971955|Procedure|Adipose Tissue Biopsy|The abdominal skin 6-10 cm lateral to the umbilicus will be cleansed with chlorhexidine. A sterile drape is placed, and the skin and adipose tissue will be anesthetized using Lidocaine. A 3-4 mm Mercedes Liposuction cannula will be inserted for aspiration of up to 2g of adipose tissue.
15858771|NCT03971942|Behavioral|Neutral ABMT|In the neutral attention bias, there are 108 pairs of neutral-negative words, 54 pairs of which are used in the training group and 54 pairs of which are used in the placebo group. The word pairs in each group are repeated 4 times, with a total of 216 trial. Participants received 8 sessions over 2 weeks (1 session every other day).In booster ABMT, participants received 4 sessions over 2 weeks (1 session every three days).90% of the targets in the training group appear in the neutral word position and 10% of the targets appear in the negative word position, while 50% of the targets in the placebo group appear in the neutral word position and 50% of the targets appear in the negative word position.
15858772|NCT03971942|Behavioral|Positive ABMT|In the positive attention bias, there are 54 pairs of neutral-negative words, 27 pairs of which are used in the training group and 27 pairs of which are used in the placebo group. The word pairs in each group are repeated 8 times, with a total of 216 trial.Participants received 8 sessions over 2 weeks (1 session every other day). In booster ABMT, participants received 4 sessions over 2 weeks (1 session every three days).90% of the targets in the training group appear in the positive word position and 10% of the targets appear in the neutral word position, while 90% of the targets in the placebo group appear in the neutral word position and 10% of the targets appear in the positive word position.
15858776|NCT03971916|Drug|HBM9161(HL161BKN)|Subcutaneous injection; Single dose on Day 1
15858777|NCT03971916|Drug|Placebo|Subcutaneous injection; Single dose on Day 1
15858778|NCT03971903|Behavioral|Attention bias modification|The ABM training task was a variation of the computerized visual dot-probe task. During the training, each session includes 54 neutral-sad word pairs presenting 6 times (6 × 54=324 trials) during 20-minute. Participants received 12 sessions over 4 weeks (1 session every other day). In the active ABMT, 90% of the probes appeared at the neutral position and 10% at the sad position. At the placebo ABMT, 50% of the probes appeared at the neutral position and 50% at the sad position.
15858779|NCT03971890|Other|Dance therapy|The experimental group will receive a dance treatment.This protocol will be administered at weekly sessions of 60 minutes with a period of 2 times / week with a total of 16 sessions, distributed over a 8-week period. They will be evaluated at baseline, after the end of the last treatment session.
15858780|NCT03971890|Other|Educational group|The control group will receive an educational intervention. They will be evaluated at baseline, after the end of the last treatment session.
15859003|NCT03970252|Drug|Leucovorin Calcium|Given IV
15859004|NCT03970252|Biological|Nivolumab|Given IV
15859005|NCT03970252|Drug|Oxaliplatin|Given IV
15858781|NCT03971877|Diagnostic Test|Rapid Polymyxin NP test|From rectal swabs of patients admitted in ICU and oncohaematology ward, investigators will use first a new culture medium (SuperPolymyxin) for screening the colistin resistant Gram negative and then a new rapid test (Rapid Polymyxin NP test) to confirm this resistance. These tests will be compared to the reference test of MIC (Minimal Inhibitory Concentration) determined by the broth micro-dilution (BMD) method.
15858782|NCT03971851|Other|Frailty risk groups|Patients older than 65 will be separated into groups of varying frailty risk
15858783|NCT03971838|Behavioral|Positive Outcomes for Women|"Women and their children 10+ can consent to participate in the diabetes prevention programming offered through the research center. We will collect data at three time points, baseline, 4-6 months, and 12 months.
~2. Instead of participating in Encourage, women may participate in other diabetes prevention programming/weight management programming offered by other entities. Researchers will consent these women into the study to complete 3 data collection points, baseline, 4-6 months, and 12 months. Additionally, researchers will consent women to obtain data from their chosen program. For instance, if a woman chooses to do a Diabetes Prevention Program through the YMCA, researchers will ask women to self report their weekly attendance and weight."
15858784|NCT03971825|Drug|CC-92252|CC-92252
15858785|NCT03971825|Other|Placebo|Placebo
15858786|NCT03971812|Biological|Blood sample|A blood sample of two 10 mL ethylenediaminetetraacetic (EDTA) tubes will be taken at the time of the visit. This sample will be centrifuged for isolation of peripheral blood mononuclear cells (PBMC).
15858787|NCT03971799|Biological|CD33CART|"The treatment regimen will consist of lymphodepleting chemotherapy followed by CD33CART infusion:
~Days -4 to -2: fludarabine 25 mg/m2/dose Day -2: cyclophosphamide 900 mg/m2/dose Day 0: CD33CART infusion (starting at dose level 1 [DL1]: 3 x 105 transduced CAR-T cells/kg) on Day 0 Subjects will be evaluated for response at Day 28 (+/- 7 days) post-CD33CART infusion via bone marrow and lumbar puncture evaluation. Subjects will then proceed to allogeneic HCT or alternative therapy as clinically applicable."
15858788|NCT03971786|Behavioral|Quality of life|Assessment of quality of life through measuring scales
15858789|NCT03971773|Other|hypnosis|patient with cancer will undergo sessions of hypnosis
15858790|NCT03971760|Other|Suction drain removal|Removal of negative pressure suction drain left in place to drain the surgical space after a neck surgery
15858791|NCT03971747|Biological|AFP Specific T Cell Receptor T Cells|Autologous T cells transduced with lentivirus encoding AFP specific TCR gene
15858792|NCT03971734|Drug|Regadenoson 0.05mg|Regadensoson 0.05mg administered prior to MRI
15858793|NCT03971734|Drug|Regadensoson 0.1mg|Regadensoson 0.1mg administered prior to MRI
15858794|NCT03971734|Drug|Regadensoson 0.2mg|Regadensoson 0.2mg administered prior to MRI
15858795|NCT03971734|Drug|Regadensoson 0.4mg|Regadensoson 0.4mg administered prior to MRI
15858796|NCT03971734|Drug|Regadensoson 0.7mg|Regadensoson 0.7mg administered prior to MRI
15858797|NCT03971734|Drug|Regadensoson 1.0mg|Regadensoson 1.0mg administered prior to MRI
15858798|NCT03971734|Drug|Regadensoson 1.4mg|Regadensoson 1.4mg administered prior to MRI
15858799|NCT03971721|Device|Wave 4.3|The Wave 4.3 mattress support is an insert, placed underneath the user's existing mattress, that when inflated increases the longitudinal incline of the mattress support, increasing in inclination in the direction of the head of the bed. The resulting mattress contours are such that the mattress has a lateral inclination of approximately 15 degrees in the head section and 10 degrees in the torso section. In addition to the features allowing the user to activate and deactivate creation of this Graduated Lateral RotationTM orientation, this device has sensors and monitoring system allowing for remotely monitoring the status of the system, including confirming that the supports are achieving the prescribed support angles, and that the system is working as planned.
15858800|NCT03971708|Drug|Lidocaine|Local anesthetic
15858801|NCT03971708|Drug|Ropivacaine|Local anesthetic
15858802|NCT03971695|Drug|BI 706321|Capsule or Oral Solution
15858803|NCT03971695|Drug|Placebo|Capsule or Oral solution
15858804|NCT03971682|Behavioral|PSYCHOPATHY.COMP program.|"The PSYCHOPATHY.COMP program is a structured individualized program for detained youth based on Compassion Focused Therapy, aimed to develop a compassionate motivation in these youth.
~Treatment As Usual Treatment As Usual (TAU) in Portuguese juvenile detention facilities is primarily aimed to increase educational and professional qualifications, as well as to promote behavioral regulation."
15858805|NCT03971682|Other|Treatment As Usual - TAU|Treatment As Usual (TAU) in Portuguese juvenile detention facilities is primarily aimed to increase educational and professional qualifications, as well as to promote behavioral regulation.
15858806|NCT03971669|Drug|Vivotif Typhoid Oral Vaccine|The 4 doses (1 capsule each) will be administered on alternate days, e.g., days 0, 2, 4, and 7 (± 1 day) under the supervision of the study coordinator(s).
15858807|NCT03971656|Dietary Supplement|Nutritional Supplement|Oral nutritional supplementation
15858808|NCT03971656|Behavioral|Preoperative Dietitian Consult|Nutritional assessment
15858809|NCT03971656|Behavioral|Education|Informational materials about nutrition
15858810|NCT03971643|Drug|IFX-1|IV infusions of IFX-1 diluted in sodium chloride.
15858811|NCT03971630|Other|Telemedicine|Patients will be followed up using the MyVENT System and APP
15858812|NCT03971617|Drug|Hydrogen|each hydrogen tablet contains 80mg magnesium
15858813|NCT03971617|Drug|Placebo oral tablet|matching placebo tablet
15858814|NCT03971604|Drug|Vitamin A|treated with Vitamin A
15858815|NCT03971604|Drug|Vitamin E|treated with Vitamin E
15858816|NCT03971591|Behavioral|Guided Lifestyle Program Intervention|The Guided Lifestyle Program will receive sessions that meet twice weekly and 2-3 text messages weekly. They will also receive a participant informational binder with health and exercise information and tools as directed by ACS nutrition and physical activity guidelines.
15858817|NCT03971578|Other|No Intervention Provided|No Intervention Provided
15858818|NCT03971565|Biological|Blood sample 5 milliliter|The blood of the patients will be collected during their hospitalization of the hematology department participating in the research
15858819|NCT03971552|Procedure|gadolinium-enhanced extracranial magnetic resonance angiogram|288 of the 912 acute ischemic stroke patients received gadolinium-enhanced extracranial MRA additionally to the standardized stroke MRI imaging protocol.
15858820|NCT03971539|Drug|BI 894416|Tablet
15858821|NCT03971539|Drug|Placebo|Tablet
15858823|NCT03971513|Procedure|Trans abdominal plane|"Trans abdominal plane block is performed with ultra sound guidance.
~- The high frequency probe is placed right to the umbilicus, and slips laterally to the side to block. It allows showing the three belts of larges muscles of abdomen (External Oblicum, internal oblicum, and transversal of the abdomen).
~- When the needle is visualised in the plan separating the muscle internal oblicum and transversal of the abdomen, 20 ml of ropivacaïne 5mg/ml are injected after aspiration test. If in doubt, hydro localisation car be realised."
15858824|NCT03971500|Drug|AntiPlatelet therapy|AntiPlatelet therapy with ticagrelor + aspirin or ticagrelor alone.
15858825|NCT03971500|Procedure|Percutaneous coronary intervention|PCI with DES implantation
15858826|NCT03971487|Behavioral|Psychosis and cognitive assessments|Administration of MINI, PANSS and Quality of Living scales
15858827|NCT03971487|Behavioral|Physical and neuro-cognitive evaluations|Physical, neurological and cognitive evaluations.
15858828|NCT03971487|Diagnostic Test|Safety labs and electrocardiogram|Metabolic panel, CBC and differential, urinalysis, ECG, recreational drugs. CD19+ B-cell count.
15858829|NCT03971487|Biological|Ocrelizumab infusion|Two IV infusions of 300 mg of ocrelizumab 2 weeks apart
15858830|NCT03971474|Drug|Docetaxel|Given IV
15858831|NCT03971474|Drug|Gemcitabine|Given IV
15858832|NCT03971474|Drug|Gemcitabine Hydrochloride|Given IV
15858833|NCT03971474|Biological|Pembrolizumab|Given IV
15858834|NCT03971474|Drug|Pemetrexed|Given IV
15858835|NCT03971474|Drug|Pemetrexed Disodium|Given IV
15858836|NCT03971474|Biological|Ramucirumab|Given IV
15858837|NCT03971461|Drug|Lutathera|administered intravenously every 8 weeks for a total of 4 doses
15858838|NCT03971448|Device|LPWB|The LPWB will be placed by clinical staff who will have been trained on the proper application of this device at the initial ED visit. At ED discharge, both populations will receive identical documentation on recommendations for weight bearing, type and frequency of analgesics, reasons to return for medical attention. The only difference will be care instructions related to the specific immobilization device. Specifically, the experimental group will be permitted to remove the LPWB as early as one week post ED visit as tolerated by the patient's symptoms.
15858839|NCT03971448|Device|AKWC|If the patient is randomised to AKWC, it will be apply by a cast technician. Children with AKWC immobilization will be provided with up to two appointments in the orthopedic clinic. In case the AKWC could not been placed at initial visit, the first will be within 72 hours of the ED visit to have the fiberglass AKWC placed. The second appointment will be for cast removal.
15858842|NCT03971409|Biological|Anti-OX40 Antibody PF-04518600|Given IV
15858843|NCT03971409|Drug|Avelumab|Given IV
15858844|NCT03971409|Drug|Binimetinib|Given PO
15858845|NCT03971409|Biological|Utomilumab|Given IV
15858846|NCT03971409|Drug|Liposomal Doxorubicin|Given IV
15858847|NCT03971409|Drug|Sacituzumab Govitecan|Given IV
15858848|NCT03971396|Other|Physiotherapists working in intensive care|Physiotherapists working in intensive care will be reached by mail or telephone. Physiotherapists will be asked to complete the prepared questionnaire.
15858849|NCT03971383|Drug|Aolanti Weipang Tablets|3 tablets one time, 3 times a day(tid)
15858850|NCT03971383|Drug|Placebo|3 tablets one time, 3 times a day(tid)
15858851|NCT03971370|Biological|Human diploid cell rabies vaccine (Minhai Biothechnology Co., Ltd)|Essen post-exposure immunization schedule at day 0,3,7,14,28.
15858852|NCT03971370|Biological|Human diploid cell rabies vaccine (Minhai Biothechnology Co., Ltd)|Zagreb post-exposure immunization schedule at day 0,7,21.
15858853|NCT03971370|Biological|Human diploid cell rabies vaccine (Chengdu Kanghua Biological Products Co., Ltd.)|Essen post-exposure immunization schedule at day 0,3,7,14,28.
15858854|NCT03971357|Drug|Netarsudil|netarsudil opthalmic solution 0.02%
15858855|NCT03971357|Drug|Placebo|Placebo eye drops
15858856|NCT03971331|Device|PAC catheter and critical care ultrasound examination|Patients in study group were placed the PAC and performed critical care ultrasound(CCUS) to monitor the pathophysiological changes of the lung and the hemodynamics immediately
15858857|NCT03971292|Genetic|RNA sequencing|Testing interest of messenger RNA sequencing for the etiological diagnosis of unresolved patients after sequencing coding regions.
15858858|NCT03971279|Drug|Dexamethasone Ophthalmic implant|intravitreal injection of ozurdex implant
15858859|NCT03971266|Device|Activity Monitor|Wear a Fitbit
15858860|NCT03971266|Other|Media Intervention|Complete smartphone based PRO diary
15858861|NCT03971253|Drug|Peficitinib|Oral
15858862|NCT03971240|Procedure|evacuation of traumatic acute subdural hematoma|craniotomy will be done with evacuation of the hematoma
15858863|NCT03971227|Device|Acuity 200 (Fluoroxyfocon A) contact lens|Daily wear rigid gas permeable contact lens
15858864|NCT03971227|Device|Acuity 100 (Hexafocon A) contact lens|Daily wear rigid gas permeable contact lens
15858865|NCT03971214|Drug|PD-1 inhibitor JS-001|The extensive-stage SCLC patients will receive PD-1 inhibitor treatment after standard first-line chemotherapy, chest radiotherapy ± SABR for metastasis disease, and propylactic cranial irradiation untill disease progression or death.
15858866|NCT03971201|Procedure|hepatic resection|removal of portion of liver containing cancer
15858867|NCT03971201|Drug|Sorafenib|sorafenib either as adjuvant therapy after resection or as only treatment
15858868|NCT03971188|Procedure|Trapeziectomy with Internal Brace|Trapeziectomy is performed in standard fashion. Longitudinal traction applied to thumb. Suture anchor with suture tape is inserted into drill hole at radial thumb metacarpal base. A second suture anchor is inserted into a drill hole at the radial base of the index metacarpal such that the suture tape suspends the thumb at the natural groove. Thumb position and tension assessed.
15858869|NCT03971175|Procedure|Forceps biopsy|Endobronchial biopsy with the forceps
15858870|NCT03971175|Procedure|Cryobiopsy|Endobronchial biopsy with the cryobiopsy probe
15858871|NCT03971162|Drug|3+PRN|intravitreal injection of Conbercept 0.5mg every month repeated for 3 months,
15858872|NCT03971162|Drug|6+PRN|intravitreal injection of Conbercept 0.5mg every month repeated for 6 months
15858873|NCT03971149|Behavioral|EMPOWER|EMPOWER includes 4 weekly home visit and 4 follow up booster phone calls every other week for the following 8 weeks. The trained nurse interventionist will address identified adherence barriers related to knowledge deficits about heart failure and its treatment including psycho-social barriers and logistic barriers with their primary care physician if necessary.
15858874|NCT03971136|Diagnostic Test|pulmonary ultrasound|The subjects will have an ultrasound on admission and on day 1, 2 and 3
15858875|NCT03971123|Drug|Tricaprilin|Tricaprilin formulated as AC-SD-03 50g of AC-SD-03 (20g tricaprilin) mixed in 240mL dosing liquid at Hour 0 Day 1
15858876|NCT03971123|Drug|Tricaprilin|Tricaprilin formulated as AC-LMP-01 50g of AC-LMP-01 (20g tricaprilin) mixed in 240mL dosing liquid at Hour 0 Day 1
15858877|NCT03971123|Drug|Placebo|Matching placebo to AC-SD-03 50g of AC-SD-03P mixed in 240mL dosing liquid at Hour 0 Day 1
15858878|NCT03971123|Drug|Tricaprilin|Tricaprilin formulated as AC-1202 60g of AC-1202 (20g caprlic triglyceride) mixed in 240mL dosing liquid at Hour 0 Day 1
15858879|NCT03971110|Drug|Zoladex and Casodex|The eligible subjects will receive Casodex 50 mg orally per day in combination with Zoladex 10.8 mg implant subcutaneously as neoadjuvant therapy per 12 weeks for up to 24 weeks.
15858880|NCT03971097|Behavioral|Six Step Model of Self-Forgiveness|"The six-step model includes a workbook that applies Worthington's (2013) conceptualization of self-forgiveness and guides the practitioner and participant through the self-forgiveness process. Each step provides a framework for techniques and includes psychoeducation, interventions, and homework to be completed in between sessions. The individual sessions will not conflict with the timing or content of the unit's regular treatment schedule, thus, participation in the study will not affect a patient's ability to participate in TAU. All interventions will be done individually to ensure that participant confidentiality is respected throughout the therapeutic process."
15858881|NCT03971097|Behavioral|Treatment as Usual (TAU)|Treatment as Usual (TAU) includes four group therapy sessions facilitated by the social services team (counselors and social workers), two 12-step meetings facilitated by outside representatives of Alcoholics Anonymous (AA) and Narcotics Anonymous (NA), dietary, spirituality, medical care including vital signs and the administration of prescribed medication by the nursing staff, and individual needs assessment with a recommendation of appropriate aftercare.
15858884|NCT03971071|Drug|Erenumab 70 mg|Erenumab once every 4 weeks. Subcutaneous injection.
15858885|NCT03971071|Drug|Erenumab 140mg|Erenumab once every 4 weeks. Subcutaneous injection.
15858886|NCT03971071|Drug|Placebo|Placebo once every 4 weeks. Subcutaneous injection.
15858887|NCT03971058|Biological|IXIARO®- Japanese Encephalitis vaccine|Booster Immunisation With IXIARO®- Japanese Encephalitis vaccine
15858888|NCT03971045|Drug|Pembrolizumab|Patients will be treated with pembrolizumab administered as an intravenous infusion at 200 mg in 21-day treatment cycles and oral cyclophosphamide (CTX) 50 mg per day in metronomic administration as a 21 days cycle
15858889|NCT03971032|Procedure|Hysteroscopy|Diagnostic procedure
15858890|NCT03971032|Device|Infrared Spectroscopy|This device uses spectral absorption of the tissue taken during hysteroscopy to determine immediate diagnosis of malignancy
15858891|NCT03971019|Drug|statins|On the basis of dietary intervention. Simvastatin 20mg/d QN Po (half an hour before bedtime) (dosage can be adjusted according to other indicators of blood lipid level in each review), atorvastatin 10mg/d QN Po (half an hour before bedtime) (patients who can not tolerate the side effects of simvastatin can consider replacing this drug).
15858892|NCT03971019|Behavioral|Dietary intervention group (control group)|Restriction of dietary components that increase LDL-C Saturated Fatty Acids Less than 7% of total energy Dietary cholesterol < 300 mg/d Increasing Dietary Ingredients for Reducing LDL-C Phytosterol 2~3 g/d Water soluble dietary fiber 10~25 g/d total energy Adjusted to maintain ideal weight or lose weight Physical activity Maintain moderate intensity exercise and consume at least 200 kcal of calories per day
15858893|NCT03970993|Biological|R21 Matrix-M vaccination|Three dose vaccination of 2μg, 10μg or 50μg of R21 and 50ug Matrix-M delivered intramuscularly
15858894|NCT03970993|Biological|R21 Matrix-M vaccination and CHMI|Three dose vaccination of 2μg, 10μg or 50μg of R21 and 50ug Matrix-M delivered intramuscularly. Volunteers then have the option to be challenged with malaria by mosquito bite
15858895|NCT03970993|Biological|R21 Matrix-M vaccination booster|Optional R21 Matrix-M vaccination booster following a three dose vaccination schedule
15858896|NCT03970980|Other|fraction of inspired oxygen (FIO2)|Different group receives different (70% vs. 90%) fraction of inspired oxygen (FIO2) during the surgery.
15858897|NCT03970967|Device|Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)|An intratumoral insertion of radioactive sources [Ra-224 containing stainless-steel 316LVM tubes- (Alpha DaRT seeds)]. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.
15858898|NCT03970954|Drug|low-dose IL-2|Subcutaneous injection of low dose of IL-2 for induction course of 5 days, the 10th day after the beginning of periods. At most 5 courses of low dose of IL-2.
15858899|NCT03970941|Other|Cost evaluation|The cost for the hospital of the strategy of management will be evaluated.
15858900|NCT03970941|Other|Questionnaire|The quality of life of patients will be measured.
15858901|NCT03970928|Device|PVI|A pulse oximetry probe which transfers data to the monitor with software able to calculate PVI data. The monitor automatically and continuously calculates the respiratory variations in the photoplethysmogram from data collected noninvasively via a pulse oximetry sensor.
15858902|NCT03970915|Device|Body warmer|The body warmer will be wrapped in a waterproof treatment field to avoid the risk of burns, 2 body warmer will be applied on the inguinal crease and 2 on the subclavicular fossa.
15858903|NCT03970915|Device|Standard warming procedure|Warming only according to the standard procedure : survival blanket and heating in the emergency vehicle.
15858996|NCT03970291|Device|PMD-200|The PMD-200 system is comprised of a console and designated finger probe with 4 sensors. The Sensors are Photoplethysmography (PPG) Galvanic Skin Response (GSR), Accelerometer (ACC) and Thermistor (TMP)
15858997|NCT03970278|Other|No intervention|No intervention
15858904|NCT03970902|Other|Integrated Osteoporosis Care|Complex intervention in family physicians, primary caregivers, patients, informal caregivers. The intervention has a patient-tailored implementation. Family physicians: postgraduate education on osteoporosis management and integrated care, educational material. Primary care stakeholders (nurses, pharmacists, dietitians, physiotherapists): specialist training on patient-support in osteoporosis management with attention towards self-management support (nurses), treatment adherence and administration (pharmacists), fall risk, weight-bearing exercises, balance training and fear of falling (physiotherapists) and anti-inflammatory nutrition with sufficient calcium, vitamin D and protein intake (dietitians). Patients: patient-tailored complex intervention consisting of: education, support consultation(s)/telephones from an osteoporosis nurse, a pharmacist, a physiotherapist and nutritional a dietitian. Informal caregivers: education on supporting osteoporosis self-management.
15858905|NCT03970902|Other|Care As Usual|No intervention Patients receive care as usual from their family physician
15858906|NCT03970889|Device|Klue|Klue is a software program the uses an Apple watch to detect hand motions which are indicative of eating.
15858907|NCT03970876|Biological|ATGC-100|Clostridium Botulinum Type A
15858908|NCT03970876|Biological|Botox®|Clostridium Botulinum Type A
15858909|NCT03970863|Diagnostic Test|Prostate Health Index|Use Prostate Health Index for the follow-up after focal therapy.
15858910|NCT03970850|Diagnostic Test|NeuMoDx CT/NG Assay|NeuMoDx CT/NG Assay as implemented on NeuMoDx 288 Molecular System and NeuMoDx 96 Molecular System
15858911|NCT03970850|Diagnostic Test|FDA-cleared NAATs|Testing swabs and urine specimen from both male and female subjects on the FDA-cleared NAATs
15858912|NCT03970837|Biological|GSK3196165 (Otilimab)|GSK3196165 solution in vial/pre-filled syringe (PFS) to be administered SC.
15858913|NCT03970837|Drug|Tofacitinib|Tofacitinib cap (over encapsulated 5mg tablet) to be administered orally.
15858914|NCT03970837|Drug|Placebo to GSK3196165 (Otilimab)|Placebo sterile 0.9 percentage (%) weight by volume (w/v) sodium chloride solution in vial/pre-filled syringe (PFS) to be administered SC.
15858915|NCT03970837|Drug|Placebo to Tofacitinib|Placebo cap (containing lactose) to be administered orally.
15858916|NCT03970837|Drug|csDMARDs|Stable dose of csDMARD(s) as SoC.
15858917|NCT03970824|Biological|CT-P17|40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS
15858918|NCT03970824|Biological|US-licensed Humira|40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS
15858919|NCT03970824|Biological|EU-approved Humira|40 mg/0.4ml (100 mg/mL) administered as a single SC injection via PFS
15858920|NCT03970811|Procedure|Immediate Implants|dental implants are immediately placed after tooth extraction
15858921|NCT03970811|Procedure|temporary restoration|temporary restoration will be placed immediately after implant placement
15858922|NCT03970811|Procedure|final restoration|final restoration (loading) will be placed 3 months postsurgical
15858923|NCT03970798|Drug|Midazolam|In Period 1, Day 1 a single dose will be administered after fasting for at least 10 hours. In Period 2, Day 11 a single dose will be administered after fasting for at least 10 hours.
15858924|NCT03970798|Drug|Caffeine|In Period 1, Day 1 a single dose will be administered after fasting for at least 10 hours. In Period 2, Day 11 a single dose will be administered after fasting for at least 10 hours.
15858925|NCT03970798|Drug|Rosuvastatin|In Period 1, Day 1 a single dose will be administered after fasting for at least 10 hours. In Period 2, Day 11 a single dose will be administered after fasting for at least 10 hours.
15858926|NCT03970798|Drug|KW-6356|In Period 2, Day 4-13(except Day11) a single dose of KW-6356 will be administered after breakfast, Day 11 a single dose of KW-6356 will be administered after fasting for at least 10 hours.
15858927|NCT03970772|Drug|Glucagon Injection|Participants will be instructed to check their blood glucose (BG) with study meter once they developed hypoglycemia symptoms, their CGM reads below 70 mg/dl, or when the CGM glucose was trending down and the participant intended to treat to prevent hypoglycemia. Participants will be instructed to check BG with meter 3 times and treat the hypoglycemia event using mini-dose glucagon when their BG in range 40-69 mg/dl according a prescribed protocol.
15858928|NCT03970772|Other|Glucose Tablets|Participants will be instructed to check their blood glucose (BG) with study meter once they developed hypoglycemia symptoms, their CGM reads below 70 mg/dl, or when the CGM glucose was trending down and the participant intended to treat to prevent hypoglycemia. Participants will be instructed to check BG with meter 3 times and treat the hypoglycemia event using glucose tablets when their BG in range 40-69 mg/dl according a prescribed protocol.
15858929|NCT03970759|Drug|Stannous Fluoride Dentifrice|Experimental stannous fluoride (0.454%) dentifrice
15858930|NCT03970759|Drug|Positive control dentifrice|Positive control dentifrice containing (0.3%) triclosan.
15858931|NCT03970759|Drug|Negative control dentifrice|Negative control dentifrice containing either sodium fluoride (0.243%) or sodium monofluorophosphate (0.76%)
15858932|NCT03970746|Biological|PDC*lung01|PDC*lung01 includes, in similar proportion, seven active agents, made of irradiated human plasmacytoid dendritic cells (PDC) loaded separately with a distinct synthetic peptide encoded by a lung tumor antigen, namely NY-ESO-1, MAGE-A3, MAGEA4, Multi-MAGE (an epitope common to several MAGE-A antigens), SURVIVN, MUC1 or a peptide derived from the Melan-A antigen.
15858933|NCT03970746|Drug|Keytruda Injectable Product|The intention and decision to prescribe the anti-PD-1 monotherapy as SoC (TPS≥50%) must have been made by the investigator before and regardless of the patient's participation in the study.
15858934|NCT03970746|Drug|Alimta Injectable Product|For patients with non-squamous NSCLC included in Cohorts A1 and A2, maintenance by pemetrexed (IV every 3 weeks) can be administered according to SoC.
15858935|NCT03970733|Biological|VLA15|a multivalent recombinant Outer Surface Protein A (OspA) based vaccine candidate
15858936|NCT03970733|Biological|Placebo|PBS (Phosphate Buffered Saline)
15858937|NCT03970720|Drug|Metoclopramide|10 mg metoclopramide four times a day
15858938|NCT03970720|Drug|Placebo|10 mg matching placebo capsules four times a day
15858939|NCT03970707|Other|Small Number of Players training protocol A|8 participants each side game (4vs4), size of pitch area 25*20 m. In total, 6 consecutive 4-minutes bouts interspersed by a 3-minutes rest between each bout will be executed.
15858940|NCT03970707|Other|Large Number of Players training protocol B|16 participants each side game (8vs8), size of pitch area 25*20 m. In total, 3 consecutive 8-minutes bouts interspersed by a 1-minutes rest between each bout will be executed.
15858941|NCT03970694|Radiation|Radiotherapy|"Since 2006, neoadjuvant chemoradiotherapy has been a recommendation as standard treatment for locally advanced rectal cancer, and has been widely applied to clinical use. As for locally advanced colon cancer, it still lacks evidence to support whether neoadjuvant chemoradiotherapy is a beneficial option.We recently reported clinical data about therapeutic effect of 60 unresectable locally advanced colon cancer cases and it was exciting. According to our results, through neoadjuvant chemoradiotherapy, R0 resection rate is 86%, local recurrence rate is 10.2%, 3-year OS and 5-year OS are 76.7% and 66.6%, respectively.Colorectal cancer diagnoses and treatment guidelines written by Chinses Society of Clinical Oncology (ver. 2017, 2018), suggested that neoadjuvant chemoradiotherapy was an optional treatment strategy or secondary recommended treatment strategy."
15858942|NCT03970694|Drug|oxaliplatin+capecitabine|Colorectal cancer is one of the most common malignant tumors, the morbidity and mortality rate are both in rising trend. 10-23% newly diagnosed colon cancer is at locally advanced stage and surgical unresectable. For this subgroup, treatment guidelines recommend neoadjuvant chemotherapy with or without targeted therapy.
15858943|NCT03970668|Drug|Linagliptin 5 mg Oral Tablet|Patients received linagliptin 5mg once daily orally plus a basal bolus insulin scheme, if they presented hyperglycemia (glucose levels above than 140 mg/dl)
15858944|NCT03970668|Drug|Insulin|Patients received a basal bolus insulin scheme, if they presented hyperglycemia (glucose levels above than 140 mg/dl)
15858945|NCT03970655|Drug|Bupivacaine with epinephrine plus dexamethasone - Group 1|Group 1 will receive 4 ml of 0.5% Bupivacaine with epinephrine in the LEFT pterygopalatine fossa
15858946|NCT03970655|Drug|Bupivacaine with epinephrine plus dexamethasone - Group 2|Group 2 will receive 4 ml of 0.5% Bupivacaine with epinephrine in the RIGHT pterygopalatine fossa
15858947|NCT03970642|Other|Video directly observed therapy|The intervention group will receive individualized text reminders on their phone prior to each dose of their depression medicine. They will be requested to use the VDOT smartphone app to make a video recording of each medication dose ingested during the 3 month study period following their first visit. The app will automatically upload the video to a HIPAA compliant server. Research staff will regularly monitor videos using a password protected website and document each medication dose.
15858948|NCT03970629|Device|PERSONA Total Knee|Primary Total Knee Arthroplasty
15858949|NCT03970616|Drug|Tivozanib|Dose level 1: 1.0mg for 21 days followed by 7 days rest; Dose level -1: 1.0mg every other day
15858950|NCT03970616|Drug|Durvalumab|1500mg every 28 days
15858951|NCT03970603|Other|Early Weight-Bearing|Being directed to bear weight on the affected ankle two weeks from suture button fixation for syndesmotic disruption
15858952|NCT03970603|Other|Delayed/Late Weight-Bearing|Being directed to bear weight on the affected ankle six weeks from suture button fixation for syndesmotic disruption
15858953|NCT03970590|Behavioral|CTC Intervention|"An integrated peer narrative-based intervention (VIEW > SELECT > GET), beginning with VIEW In-person viewing of VA Stories narratives, followed by SELECT a favorite Veteran] Storyteller, and then GET favorite Storyteller narrative-aligned text messages over 6 months"
15858954|NCT03970590|Behavioral|Control|6-month HTN management assessment text messages without narrative component
15858955|NCT03970577|Drug|Rituximab|Two injections of Rituximab (375mg/m2) separated by one week (one at time of randomization and the other one week after) and definitive withdrawal of steroid at the time of second injection of Rituximab (for a total steroids exposure of 9 weeks)
15858956|NCT03970577|Drug|Prednisone|exclusive oral steroid therapy (progressively tapered with the same procedure for all patients) for a total exposure of 24 weeks (taking into account the initial oral steroid therapy administered during 8 weeks in addition with the oral steroid treatment given after randomization). Each patient will be followed up until 18 months after randomization.
15858957|NCT03970564|Diagnostic Test|Neck ultrasound guide lymph node sampling|Neck ultrasound done first and lymph nodes larger than 5 mm that are technically feasible are sampled using fine needle aspiration and/or core needle biopsy
15858958|NCT03970551|Other|Physical Counter-maneuver|Physical counter-maneuver targeted at minimizing the large drop in BP seen in IOH patients.
15858959|NCT03970551|Other|Stress Test|Stress test involving submerging your hand in ice water or performing mental arithmetic to increase sympathetic activity.
15858960|NCT03970551|Other|Functional Electrical Stimulation|A mild electrical stimulus to passively induce a leg muscle contraction with minimal sympathetic activation.
15858962|NCT03970525|Device|Venturi pump|The venturi pump makes use of the venturi effect to create a vacuum. The venturi effect creates a vacuum by the flow of a fluid, typically air, over an opening. In many phacoemulsification machines, this requires nitrogen tanks or a self-contained air compressor. The vacuum level is created within a rigid drainage cassette, to which the phaco aspiration tubing is connected. Since there is no milking of the aspiration line, the phaco tubing can be made rigid with low compliance.
15858963|NCT03970525|Device|Peristaltic vacuum pump|"The peristaltic pump uses rollers to compress the phacoemulsification outflow tubing in a peristaltic manner, thereby creating flow and vacuum. The compression of the rollers on the tubing with the rotation of the pump physically moves fluid and creates a continuous milking action on the fluid column, The phaco machine can directly control this flow level, hence the term flow based, however, the preset vacuum level is only achieved once there is occlusion of the outflow line, typically at the phaco needle tip with cataract material."
15858964|NCT03970512|Device|Apioc-A and Apioc-S Contact Lenses|Appropriately fit, document and dispense a new spherical and toric contact lens design worn for up to 35 days.
15858965|NCT03970499|Procedure|brain tumor resection|Intraoperative brain ultrasound elastography and ultrasensitive doppler during surgery
15858966|NCT03970486|Procedure|Dry needling|For the needle manipulation technique, the needle will be pulled in and out (sparrow pecking) and redirected in small angles (coning) for 5-10 seconds. For the in situ technique, the needles will stay (in situ) in the left and right lumbar multifidus muscles for 10 minutes after the insertion of the needle.
15858967|NCT03970473|Other|Pulmonary recruitment maneuver (PRM)- 30 cm H2O|Pulmonary recruitment maneuver (PRM) consists of five manual pulmonary inflations where each positive pressure inflation will be performed for 5 s at a maximum pressure of 30 cm H2O in the semi-fowler position (30° head-of-bed elevation ). PRM is performed after LS when the main umbilical port is remaining and aims to remove the remaining gas following LS.
15858968|NCT03970473|Other|Pulmonary recruitment maneuver (PRM)- 15 cm H2O|Pulmonary recruitment maneuver (PRM) consists of five manual pulmonary inflations where each positive pressure inflation will be performed for 5 s at a maximum pressure of 15 cm H2O in the semi-fowler position (30° head-of-bed elevation ). PRM is performed after LS when the main umbilical port is remaining and aims to remove the remaining gas following LS.
15858969|NCT03970460|Device|Primary TKA with cemented modular metal-backed tibial implant|Tibial implant will be done with a cemented implant
15858970|NCT03970460|Device|Primary TKA with uncemented trabecular metal|Tibial implant will be done with a uncemented implant
15858971|NCT03970447|Drug|Temozolomide|Dosage Form: Capsule for oral administration Strengths: 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg
15858972|NCT03970447|Drug|Lomustine|Dosage Form: Capsule for oral administration Strength: 5 mg, 10 mg, 40 mg, and 100 mg
15858973|NCT03970447|Drug|Regorafenib|Dosage Form: Tablet for oral administration Strength: 40 mg Standard Regimen: 160 mg orally (PO) every day (QD) for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off)
15858974|NCT03970447|Radiation|Radiation|60 Gy
15858975|NCT03970447|Drug|Paxalisib|Dosage Form: Tablet for oral administration Strength: 15 mg Standard Regimen: 45 mg orally (PO) every day for 28 days for the first cycle. If tolerated, increase dose to 60 mg orally (PO) every day for 28 days for all subsequent cycles
15858976|NCT03970447|Drug|VAL-083|Dosage Form: Infusion for intravenous administration Strength: 30 mg/m2 Standard Regimen: 30 mg/m2 on Day 1, 2 and 3 of 21-day cycle. The drug is available in powder form. It is reconstituted with 5 mL of 0.9% Sodium Chloride for Injection, USP. This will produce a solution of 40 mg VAL-083 in 5 mL. The required volume of reconstituted VAL-083 for the patient is then calculated at the rate of 30 mg/m2. The corresponding volume is further diluted into 250 mL of 0.9% Sodium Chloride for Injection, USP, prior to intravenous administration.
15858977|NCT03970434|Other|Venous blood collection|Venous blood collection
15858978|NCT03970434|Other|Peripheral blood collection|Peripheral blood collection
15858979|NCT03970421|Other|Observation|Check clinical status at different time intervals during 3 months
15858980|NCT03970408|Procedure|MNT1|"Participants will in supine. Arm will be position in standard MNT1. Shoulder, elbow, wrist and fingers will be maintained in the required position using a costumed splint throughout all testing.
~All movements will be limited to the range where pain or other symptoms are not provoked. Passive neck flexion and rotation will be added to MNT1 and will be applied as tensioning movements at level 3. All movements will be repeated three times and an average will be calculated. Myrin goniometer will be used to assess neck flexion and rotation. The movements order will be randomized using excel random generation function. Movements will be done by a single trained therapist. The end position will be held up to 10 seconds until median nerve excursion is recorded by US. For US capturing, the transducer will be positioned perpendicularly and aligned longitudinally with the median nerve at the wrist. Assessor will be blinded to participants grouping."
15858981|NCT03970395|Other|Osteopathic manipulative therapy (OMTh)|The Osteopathic Manipulative Therapy includes evaluation and treatment. The evaluation considers the pelvic girdle and lower limb, thorax abdominal area, pectoral girdle and upper limbs, cervical and upper thoracic area, cranial vault, cranial base and viscero cranium. The treatment is based on balanced ligamentous tension technique, myofascial release, visceral manipulation, and balanced membranous tension technique. The OMTh lasts for 45 minutes of which 15 minutes of evaluation and 30 minutes of treatment.
15858982|NCT03970395|Other|Light Touch Therapy (LTT)|The LTT is consistent with the OMT during the phase of evaluation. The treatment retains the same areas used for osteopathic approach but avoids prolonged touch in any area of the body, moving the hands every few seconds, and by flattening and softening the surface of the hands to minimize focal areas of force.
15858983|NCT03970395|Other|Repositioning therapy|"It consists of strategies that guide the parents to position the baby back to sleep, by alternating head position, the use of tummy time while supervised, and the infants must spend minimal time in car seats or other devices that promote supine positions. In active counter-positioning the parents are suggested to place some toys on the side of the head where neck rotation is limited while, when using the changing table, to alternate the end of the table at which the infant's head is placed."
15858984|NCT03970382|Biological|NeoTCR-P1 adoptive cell therapy|The investigational agent in this protocol is NeoTCR P1, an autologous adoptive T cell therapy (ACT) for patients with solid cancer. NeoTCR P1 is composed of apheresis derived CD8 and CD4 T cells that are precision genome engineered to express one autologous TCR of native sequence that targets a neoepitope (neoE) presented by human leukocyte antigen (HLA) receptors exclusively on the surface of that patient's tumor cells and not on other cells in the body.
15858985|NCT03970382|Biological|nivolumab|Nivolumab is a human IgG4 anti-PD-1 monoclonal antibody
15858986|NCT03970382|Biological|IL-2|IL-2 is a biologic response modifier. It is a type of protein called a cytokine.
15858987|NCT03970369|Behavioral|Usual care|Personalized goals and an activity prescription.
15858988|NCT03970369|Behavioral|Monitor|Participants wear a step counter to track activity goals.
15858989|NCT03970356|Other|antibiotic stewardship intervention|The intervention is multifaceted, consisting of the implementation of an algorithm for restrictive use of antibiotics as proposed in recent guidelines (Verenso, Dutch guideline), tailored in close collaboration with local stakeholders to the specific implementation setting, by means of a modified participatory-action research (PAR) approach. To support the process of intervention-tailoring and -implementation, a toolbox comprising of materials, aids and actions is developed to be used at the discretion of the local stakeholders to support implementation of the algorithm.The algorithm is congruent with the Swedish and Norwegian guidelines, which also promote more restrictive use of antibiotics in case of non-specific symptoms, even though the algorithm is more detailed.
15858991|NCT03970330|Drug|Naltrexone|4.5mg daily dose, taken orally
15858992|NCT03970330|Drug|Norethindrone Acetate|5 - 15mg daily dose, taken orally
15858993|NCT03970330|Drug|Placebo|daily placebo pill, taken orally
15858994|NCT03970317|Device|Broad Band Light|Broad Band Light Device
15859006|NCT03970252|Procedure|Therapeutic Conventional Surgery|Undergo surgery
15859007|NCT03970239|Drug|Positron Emission Tomography using [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) and [18 Fluorine]-altanserin ([18F]-altanserin)|"Imaging of the serotoninergic system with Positron Emission Tomography using [11 Carbon]-3-amino-4-(2-dimethylaminomethylphenylsulfanyl)-benzonitrile ([11C]-DASB) and [18 Fluorine]-altanserin ([18F]-altanserin). During this study, subjects will receive a single intravenous administration of approximately 4 Megabecquerel/kilogram (MBq/kg) of [11C]-DASB immediately prior to imaging using Positron Emission Tomography (PET). The effective dose in human body is about 2.1 milliSievert (mSv).
~On a separate day, subjects will receive a single intravenous administration of approximately 3.7 MBq/kg of [18F]-altanserin for 120 minutes prior to imaging using Positron Emission Tomography (PET). The effective dose in human body is about 8.4 mSv."
15859008|NCT03970239|Drug|Positron Emission Tomography using [18 Fluorine]-altanserin ([18F]-altanserin)|Imaging of the serotoninergic system with Positron Emission Tomography using [18 Fluorine]-altanserin ([18F]-altanserin). During this study, subjects will receive a single intravenous administration of approximately 3.7 Megabecquerel/kilogram (MBq/kg) of [18F]-altanserin 120 minutes prior to imaging using Positron Emission Tomography. The effective dose in human body is about 8.4 mSv.
15859009|NCT03970226|Drug|Tocilizumab|"Phase 0: One dose of tocilizumab prior to surgery
~Feasibility phase: Tocilizumab administered every 2 weeks for up to 13 cycles (approximately 1 year)."
15859010|NCT03970213|Drug|Tranexamic Acid 100Mg/Ml Inj Vil 10Ml|IV TXA given during surgery
15859011|NCT03970213|Drug|Normal Saline 0.9% Infusion Solution Bag|IV saline given during surgery
15859012|NCT03970200|Drug|Penn Microbiome Therapy - 001|Fecal Microbiota for Transplant, enema product
15859013|NCT03970200|Drug|Penn Microbiome Therapy - 002|Fecal Microbiota for Transplant, suspension product
15859014|NCT03970200|Drug|Penn Microbiome Therapy - 003|Fecal Microbiota for Transplant, capsule product
15859015|NCT03970200|Drug|Antibiotics|Standard of care antibiotics
15859016|NCT03970187|Other|Exposure-based eye contact training in Virtual Reality (VR)|"The intervention is an App for virtual reality. The VR App provides three different virtual scenarios. Participants will be asked to stand in front of a virtual audience and to maintain eye contact with audience members. The advance to higher difficulty levels is according to a pre-defined exposure scheme. Participants will be given all instructions via the App.
~There will be three sessions on one day (duration of 20 min each) in study phase 1. The indication is disproportionate fear of being evaluated by others and reduced eye contact as a typical avoidance strategy in individuals with fear of public speaking. In the study phase 2, there will be nine sessions spanning over two weeks (duration of 20 min each, with maximally one session per day). The indication is disproportionate fear of being evaluated by others and reduced eye contact as a typical avoidance strategy in individuals with fear of public speaking."
15859017|NCT03970174|Other|Care Connector care transition module|Care Connector is an electronic interprofessional communication and collaboration tool. Its features include Physician Sign-Out, documentation, interprofessional care planner, messaging, and flow planner. The newest module is a care transition module which allows physicians to electronically generate discharge summaries as well as incorporation of allied health recommendation, but also will pull information into the PODS (Patient Oriented Discharge Summary) format designed by University Health Network. This results in a patient friendly discharge instruction sheet that can be provided to patient. The intervention arm will have access to the care transition feature, while the control wards do not.
15859018|NCT03970161|Device|routine ophthalmic examination|Routine ophthalmic examination, including slit lamp, intraocular pressure, and fundus examinations using direct or indirect ophthalmoscopy after pupil dilation and optical coherence tomography (OCT) examination. Patients with DM also underwent fundus fluorescein angiography (FFA) examination.
15859019|NCT03970148|Procedure|Nd: YAG laser|Before treatment an optical coherence tomography (OCT) scan of the macula is performed to monitor possible macular oedema. After application of anesthetic and midriatics drops, the patient is positioned on the chin and forhead support (ND: YAG laser). Then, a contact lens (panfundoscope) is filled with methylcellulose and placed on the cornea. The laser is focused on the opacity that is to be treated and the first laser stamp of an initial power of 3 mJ is applied. The measured direct effect will guide in further adjustment of the laser beam power to achieve the desired effect. After treatment, a single drop of corticosteroid is applied to the patient and an ocular patch is applied. On follow up days an OCT scan of the macula is performed to monitor possible side effects.
15859020|NCT03970135|Other|Fasting|Fasting for 24 hours or until hypoglycemia (blood glucose < 3mmol/L) or symptoms of hypoglycemia
15859021|NCT03970122|Drug|GFB-887|IMP
15859022|NCT03970122|Drug|Placebo|Matching
15859023|NCT03970109|Drug|ANS-6637|200 mg (given as 2 x 100 mg tablet) and 600 mg (given as 2 x 300 mg tablet) once a day
15859024|NCT03970109|Drug|Placebo oral tablet|Placebo oral tablet
15859025|NCT03970096|Radiation|Total-Body Irradiation|Undergo TBI
15859026|NCT03970096|Drug|Thiotepa|Given IV
15859027|NCT03970096|Drug|Fludarabine|Given IV
15859028|NCT03970096|Drug|Tacrolimus|Given IV
15859029|NCT03970096|Biological|Allogeneic CD34+-enriched and CD45RA-depleted PBSCs|Given IV
15859030|NCT03970096|Drug|Methotrexate|Given IV
15859031|NCT03970096|Drug|Cyclophosphamide|Given IV
15859032|NCT03970096|Biological|Peripheral Blood Stem Cell|Given IV
15859033|NCT03970096|Drug|Cyclosporine|Given IV
15859034|NCT03970096|Drug|Sirolimus|Given IV
15859035|NCT03970096|Drug|Busulfan|Given IV
15859036|NCT03970070|Other|Informational Intervention|Complete Perioperative Ostomy Self-Management Telehealth program
15859037|NCT03970070|Other|Quality-of-Life Assessment|Ancillary studies
15859038|NCT03970070|Other|Questionnaire Administration|Ancillary studies
15859039|NCT03970070|Other|Survey Administration|Ancillary studies
15859076|NCT03969732|Drug|1. amyloid PET；2. T807 PET|"Dynamic PET acquisition for 60 minutes will be acquired after injection of 10 mCi 11C-PiB (39 frames: 8 x 15 seconds, 4 x 60 seconds, 27 x120 seconds).
~Dynamic PET imaging 3D acquisition will be acquired 80 minutes after injection of 10 mCi 18F-T807 (4 x 300 seconds)"
15859077|NCT03969719|Drug|Placebo|Placebo
15859078|NCT03969719|Drug|PF-06835919|150 mg once daily
15859079|NCT03969719|Drug|PF-06835919|300 mg once daily
15859354|NCT03967405|Device|MolecuLight PID|Hand-held, real-time fluorescence imaging device
15859040|NCT03970057|Behavioral|Internet-based Cognitive Behavioural Therapy|"MoodUP is an iCBT intervention that is tailored to perinatal women. The core content is presented via different types of devices, such as smartphones, tablets, laptops, or desktops, connected to the internet. The program is designed as an integration of online sessions, self-monitoring, homework, peer support, and therapist support.
~MoodUP consists of six online sessions focused on CBT skills for improving stress, anxiety, and depressive symptoms among at-risk antenatal women; each session takes between 30 and 40 minutes to complete. The content of the sessions will be as follows: Session 1: Managing mood, Session 2: Psychoeducation, Session 3: Cognitive restructuring, Session 4: Behavioural activation, Session5: Lifestyle modification, Session 6: Problem-solving."
15859041|NCT03970057|Other|Usual Care|Participants will receive a series of six, weekly online sessions comprising general antenatal education. The content of the sessions will be as follows: Session 1: Parenthood; Session 2: Diet; Session 3: Exercise; Session 4: Breastfeeding; Session 5: Rest and sleep and Session 6: Common pregnancy problems.
15859042|NCT03970044|Drug|Exenatide 2 MG|Glucagon-like peptide-1 receptor
15859043|NCT03970044|Drug|Dapagliflozin 10 MG|sodium-glucose co-transporter 2 (SGLT2) inhibitor
15859044|NCT03970031|Drug|MSDC-0602K|MSDC-0602K tablet
15859045|NCT03970031|Drug|Placebo|Matching tablet
15859046|NCT03970018|Other|Intra-peritoneal pressure|Measurement of intra-peritoneal pressure
15859047|NCT03970005|Behavioral|Step-Based Care Model|Care model comprised of psychosocial and pharmacological interventions in which individuals start with low-intensity interventions and progress onto progressively higher-intensity interventions until their reach remission criteria.
15859048|NCT03969992|Drug|AeroFact|Aerosolized SF-RI 1
15859049|NCT03969992|Other|nCPAP|nCPAP (nasal continuous positive airway pressure) alone
15859050|NCT03969979|Diagnostic Test|Shear wave elastography|shear wave elastogrophy will be performed
15859051|NCT03969966|Other|renal replacement therapy as clinically indicated|Continuous renal replacement therapy
15859052|NCT03969953|Drug|Rivaroxaban 2.5 Mg Oral Tablet|Rivaroxaban is an orally administered selective direct factor Xa inhibitor.
15859053|NCT03969953|Other|Placebo|Rivaroxaban matched placebo
15859054|NCT03969927|Device|Low-Fidelity PDS|"The principal investigator recently developed a low cost ($10,000) low fidelity portable driving simulator (PDS) in the University of Kansas Laboratory for Advanced Rehabilitation Research in Simulation (LARRS) that measures 25.5 Wide, 32.5 High, and 25 Deep and requires only approximately 4 square feet of space.
~This intervention uses the PDS to retrain study participants and improve their driving related skills."
15859055|NCT03969927|Device|High Fidelity Fixed-Base Simulator|This intervention uses the large high-fidelity fixed-base driving simulator to retrain study participants and improve their driving related skills.
15859056|NCT03969914|Procedure|PEEP changes|All patients will be ventilated with a tidal volume of 6 ml/kg before the RRI assessment. Further, three level of PEEP (5, 10 and 15 cmH2O) will be randomly set. For each levels of PEEP, the RRI will be evaluated
15859057|NCT03969901|Drug|IMI/REL|"Age-based dosing:
~12 to <18 years, IMI 500 and REL 250 mg, IV infusion every 6 hours
~2 to <12 years, IMI 15 and REL 7.5 mg/kg, IV infusion every 6 hours
~3 months to <2 years, to be determined (TBD)
~Birth to <3 months (TBD) NOTE: Participants with cIAI or cUTI may be switched to oral therapy after at least 3 days of IV study intervention."
15859058|NCT03969901|Drug|Active Control|"All active control medications will be chosen from a list of acceptable approved agents for each infection type (HABP or VABP, cIAI, and UTI) and will be given via IV infusion, per authorized Package Insert (PI), Summary of Product Characteristics (SPC), or international treatment guidelines.
~NOTE: Participants with cIAI or cUTI may be switched to oral therapy after at least 3 days of IV study intervention. All oral switch medications will be chosen from a list of acceptable approved agents."
15859063|NCT03969862|Device|NOVEOS® system|"The NOVEOS® System is a fully automated, high-throughput immunoassay platform that uses magnetic microbeads as a solid phase.
~This is a partially closed system that is primarily intended for the determination of specific IgE with NOVEOS® Hycor allergens. It has the CE mark."
15859064|NCT03969849|Drug|REGN5713-5714-5715|Part A: Cohort 1 - 3: Single sequential ascending subcutaneous (SC) dose Part A: Cohort 4: Single intravenous (IV) dose Part B: Single SC dose
15859065|NCT03969849|Drug|Matching placebo|Part A: Cohort 1 - 3: Single sequential ascending subcutaneous (SC) dose Part A: Cohort 4: Single intravenous (IV) dose Part B: Single SC dose
15859066|NCT03969836|Device|NeurOS system|NeurOS system pads will be placed on patients' head for monitoring.
15859067|NCT03969823|Drug|Tagrisso|Osimertinib 80mg once daily until disease progression
15859068|NCT03969810|Behavioral|Rounding Summary|Written summary of rounds
15859069|NCT03969797|Device|RADIAQBIO Heart Guardian HR-501|Arm one offers ECG data and electric shocks recorded during AED operation.
15859070|NCT03969784|Other|blood draw, tumoral biopsy tissus|Patient will have specific blood draw and part of their tumoral tissu biopsied
15859071|NCT03969771|Behavioral|Mindfulness-Based Stress Reduction (MBSR)|The MBSR program was developed by the University of Massachusetts Medical School.
15859072|NCT03969758|Drug|Ciprofloxacin|will receive tablet Ciprofloxacin (500 mg BDS) and tablet Metronidazole (800 mg TDS) for 2 weeks orally. Percutaneous aspiration or drainage of the liver abscess will be done when there is enough liquid content/pus amenable for aspiration or drainage. Percutaneous drainage or aspiration will be done in liver abscess with size of ≥ 5 cm and <5 cm respectively.
15859073|NCT03969758|Drug|Cefixime|will receive tablet Cefixime (200 mg BDS) and tablet Metronidazole (800 mg TDS) for 2 weeks orally. Percutaneous aspiration or drainage of the liver abscess will be done when there is enough liquid content/pus amenable for aspiration or drainage. Percutaneous drainage or aspiration will be done in liver abscess with size of ≥ 5 cm and <5 cm respectively.
15859074|NCT03969745|Behavioral|Time restricted feeding|Restrict energy intake window to between 8am and 4pm
15859075|NCT03969745|Behavioral|Caloric restriction|Follow a prescribed daily energy deficit of 400 kilocalories without altering nutrient timing
15859232|NCT03968419|Drug|pembrolizumab|200mg administered intravenously every 3 weeks
15859080|NCT03969706|Drug|Abemaciclib 200 MG|Subjects will be treated with abemaciclib 200mg by mouth once every 12 hours. Dosing will be continuous and administered on a 28-day cycle
15859081|NCT03969693|Radiation|Standard treatment protocol with combined chemoradiation|As for consolidative RT used in patients with early-stage Hodgkin lymphoma, the RT field must essentially include the mediastinum.
15859082|NCT03969680|Biological|Auotologous BMSCs plus autologous PRP|30 mL of bone marrow will be aspirated from the iliac crests of patients in case group. BMSCs will be isolated from bone marrow and cultured. Before injection, 30 mL of blood will be collected from each patient to produce 3ml PRP by cenrifugation. Cultured BMSCs will be collected and suspended by 3ml autologous PRP.
15859083|NCT03969680|Biological|Auotologous PRP|30 mL of blood will be collected from each patient to produce 3ml PRP by cenrifugation.
15859084|NCT03969654|Device|PERSONA Total Knee|Primary Total Knee Arthroplasty
15859085|NCT03969654|Device|Vanguard Total Knee|Primary Total Knee Arthroplasty
15859086|NCT03969654|Device|NexGen Total Knee|Primary Total Knee Arthroplasty
15859087|NCT03969641|Biological|Quadrivalent Recombinant Influenza Vaccine|The first recombinant inactivated influenza vaccine (RIV) using an insect baculovirus expression system and recombinant DNA technology
15859088|NCT03969641|Biological|Quadrivalent Inactivated Influenza Vaccine|Standard inactivated influenza vaccine (IIV) manufactured involving the use of embryonated hen eggs.
15859089|NCT03969628|Diagnostic Test|ICCMS|Risk caries assessment will consider ICCMS criteria
15859090|NCT03969615|Device|SuperNO2VA nasal positive airway pressure devic|SuperNO2VA nasal positive airway pressure device utilizes supplemental oxygen and an adjustable pressure limiting valve to maintain upper airway latency
15859091|NCT03969615|Device|Supplemental oxygen|5lpm of supplemental oxygen
15859092|NCT03969602|Behavioral|Cognitive-behavioral Therapy|The biopsychosocial approach of CBT focuses on the complex interaction between psychological, social and biological factors. The biopsychosocial model assumes that health problems are hardly ever limited to just one domain of human experience but by multiple domains of human experience. CBT helps patients understand thoughts and feelings that influence behaviors. It consists of a cognitive aspect and a behavioral aspect. The cognitive aspect is based on Becks cognitive model: the way that individuals perceive a situation is more closely connected to their reaction than the situation itself. A person's cognition has impact on their mood and emotions, their bodily reactions and their behavior. The second part of cognitive behavior therapy focuses on the actual behaviors that are contributing to the problem. The goal of CBT is to identify maladaptive thoughts and change them into more realistic and constructive thoughts to modify feelings and behavior and thereby the experience of pain.
15859093|NCT03969602|Other|Biomedical and surgery-specific education|Biomedical and surgery-specific education preoperatively and an exercise manual postoperatively.
15859094|NCT03969589|Behavioral|Reproductive Life Planning-Mental Health (RLP-MH) Intervention|RLP-MH intervention is comprised of two parts: 1) an in-person interactive session in which the participant works with an RLP-MH facilitator to explore pregnancy intentions and RLP goals, consider important factors that impact those goals (e.g. mental health and physical health conditions, psychosocial and lifestyle factors, values, preferences), and identify personal action steps to address RLP goals and 2) a 15-20 minute follow-up session in person or by phone one month later to discuss progress in addressing RLP goals.
15859095|NCT03969589|Other|Written Materials on Reproductive Life Planning|Participants will receive written materials on reproductive life planning, contraception, and VA resources. Participants will be given the materials and study staff will briefly discuss the content with the participant.
15859096|NCT03969576|Procedure|DEB-TACE|"Patients in the DEB-TACE group received a maximum dose of 4 ml of DC bead (diameter 75-500 um) loaded with a maximum dose of 150 mg of anthracyclines drugs, such as doxorubicin. The anticancer agents and the diameter of DC Bead for individual patient will be selected according to the common clinical practice of each center. Treatment endpoint consisted of stasis of flow within feeding vessel(s) or completed delivery of maximum single-session dose of 150 mg doxorubicin. TACE will be repeated on demand according to the radiological response."
15859097|NCT03969576|Procedure|cTACE|"Patients in the cTACE group were treated with anthracyclines, such as doxorubicin, in a mixture of lipiodol. Administration of the anticancer in oil emulsion was followed by injection of embolic materials such as gelfoam or PVA particles until complete stasis in segmental or subsegmental arterial branches. the tumor-feeding vessels should be superselected whenever possible. The anticancer agents for individual patient will be selected according to the common clinical practice of each center. TACE will be repeated on demand according to the radiological response."
15859098|NCT03969563|Behavioral|Mindfulness-based Stress Reduction|8-week Mindfulness-based Stress Reduction class that trains participants in mindfulness, meditation, and yoga.
15859099|NCT03969563|Behavioral|Brain Health Education|8-week Brain Health education class that teaches participants about brain-behavior relationships, nutrition, aging facts, sleep, and memory.
15859100|NCT03969550|Other|Measure of overall survival|Measure of overall survival among AR-PML (AIDS-related PML) patients, exposed or not to maraviroc (MVC), and immune reconstitution inflammatory syndrome (IRIS) onset.
15859101|NCT03969537|Other|Telemedicine follow-up visit|Study participants will experience two telemedicine (live audio/video) visits.
15859102|NCT03969524|Device|MRI|Patients will undergo magnetic resonance imaging (MRI) at baseline (T0) (before NAC) and after the 2nd cycle of neoadjuvant chemotherapy(T2). Histopathological examination (gold standard) of the surgical specimen will be done for each patient and Compared to the results of MRI.
15859103|NCT03969511|Procedure|direct angio-suite admission|Upon arrival in angio-suite and after neurological examination with scoring NIHSS and mRS, and performing the blood sample, patient undergoes rotational CBCT in order to confirm ischemic stroke. Mechanical thrombectomy is the performed as well as intravenous thrombolysis when contraindications are excluded.
15859104|NCT03969511|Procedure|standard management|Arrival is in the MRI/CT-scan room or in the emergency department. Directly after neurological examination and blood sample, patient undergoes imaging and then bridging therapy when indicated.
15859105|NCT03969485|Device|Hybrid Fractional Laser|Hybrid Fractional Laser Device
15859106|NCT03969472|Drug|probiotics|apply probiotic after operation
15859107|NCT03969472|Device|Electrophysiologic Therapy|Pelvic floor electrophysiological therapy is used after surgery
15859233|NCT03968406|Other|Quality-of-Life Assessment|Ancillary studies
15859108|NCT03969459|Biological|breast milk collection|3 samples of 20 ml of breast milk will be collected between day 0 and day 4; between day 7 and day 15; and between day 21 and day 30 after childbirth.
15859109|NCT03969459|Biological|meconium collection|3 samples of 20 ml of meconium milk will be collected between day 0 and day 4; between day 7 and day 15; and between day 21 and day 30 after childbirth.
15859110|NCT03969459|Biological|newborn feces collection|3 samples of 20 ml of newborn feces will be collected between day 0 and day 4; between day 7 and day 15; and between day 21 and day 30 after childbirth.
15859111|NCT03969459|Other|questionary of pesticide exposure of the mother|maternal questionary of pesticide exposure of the mother
15859112|NCT03969446|Drug|Decitabine|Given IV
15859113|NCT03969446|Biological|Pembrolizumab|Given IV
15859114|NCT03969433|Device|TMSi Porti|Data collections
15859115|NCT03969433|Device|Bloomlife sensor|Data collections
15859116|NCT03969420|Drug|Alvocidib (flavopiridol) and cytarabine (Ara-C)|Alvocidib (flavopiridol), administered intravenously, + cytarabine (Ara-C), administered by subcutaneous injection
15859117|NCT03969420|Drug|Alvocidib (flavopiridol)|Administered intravenously
15859118|NCT03969394|Diagnostic Test|Medical imaging|Medical Imaging consisting of 1 MRI and 1 echocardiography at baseline
15859119|NCT03969381|Radiation|diffusion weighted magnetic resonance image in lymphoma|compare between result of positron emission tomography /computed tomography and diffusion weighted imaging in followup of lymphoma
15859120|NCT03969368|Device|rPMS device|Pelvic floor muscle contractions will be induced by the rPMS device.
15859121|NCT03969368|Procedure|Pelvic floor muscle training|Control group will undergo a pelvic floor muscle training
15859122|NCT03969355|Other|Mortality|Patients who died during PICU stay
15859123|NCT03969342|Device|Point of care ultrasound training|Five-day in-person training on point of care ultrasound using portable ultrasound devices followed by remote monitoring of practice scanning
15859124|NCT03969329|Drug|Etelcalcetide|Etelcalcetide has been shown to be safe and efficacious in treating adult chronic kidney disease (CKD) patients with secondary hyperparathyroidism (SHPT) by simultaneously controlling intact parathyroid hormone (iPTH), calcium (Ca), and phosphorus and has recently been approved for use in adult patients with secondary hyperparathyroidism (SHPT) treated with hemodialysis in both the United States and Europe
15859125|NCT03969316|Procedure|Transversus abdominis plane block, Quadratus lumborum block|The TAP block which is one of the abdominal truncal blocks is performed with the blockage of the nerve group which innervates the anterior abdominal muscle wall layers. However, in QL block, the local anesthetic agent spreads through the abdominal wall and paravertebral space with the help of the perimuscular fascia to maintain the somatic analgesia.
15859126|NCT03969303|Device|Notal Vision Optical Coherence Tomography Device Version 2.5 (NOTAL-OCT V2.5)|OCT SCAN
15859127|NCT03969290|Device|Verofilcon A contact lenses|Daily disposable silicone hydrogel contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
15859128|NCT03969290|Device|Etafilcon A contact lenses|Daily disposable contact lenses indicated for the optical correction of refractive ametropia (myopia and hyperopia)
15859129|NCT03969277|Other|Graded Motor Imagery|"The first stage of GMI includes laterality reconstruction. Patients will view and determine if the various images of body parts to image portrays the right or left side. The second stage targets activation of the primary motor cortex by imagine moving the involved body part. The final stage involves that the patient watches the unaffected body part moving in a mirror to trick the brain into thinking the affected body part is actually moving in a pain-free way. This will be applied for 6 weeks."
15859130|NCT03969277|Other|Standard Rehabilitation|Shoulder, elbow and wrist AROM exercises. Elbow flexion and extension, and wrist flexion and extension stretching exercises. Elbow and wrist strengthening exercises. Grip strengthening exercises. This will be applied for 6 weeks.
15859131|NCT03969277|Other|Home Exercise Program|Proprioception exercises for the elbow. Scapulothoracic strengthening exercises. This will be applied for 6 weeks.
15859132|NCT03969277|Other|Cold Application|Cold application around the elbow joint for 15 minutes in every session.
15859133|NCT03969264|Other|High Carbohydrate or Tree Nut Food Snacks|Snack consumption
15859134|NCT03969251|Device|Transcranial Magnetic Stimulation (rTMS)|active high frequency repetitive TMS of left Dorsolateral Prefrontal Cortex
15859135|NCT03969251|Device|Sham (SS)|repetitive sham rTMS
15859136|NCT03969238|Behavioral|Helpline|This helpline will aim to provide patients with new diagnosis of pain who are prescribed opioids, access to education, support and free behavioral technique to help manage their pain such as mindfulness exercises. For those with opioid use disorder, the helpline will offer support in the form of education about the disorder, opioid withdrawal symptoms, risks of overdoses, and a variety of services such as help reach appropriate care with MAT licensed providers, information on FDA-approved MAT and naloxone, and, in some cases, behavioral intervention to keep patients engaged in treatment. The opioid helpline will provide a central resource for direct services and a portal for community services. It will also serve as a referral resource for health-care professionals.
15859137|NCT03969212|Drug|Baloxavir Marboxil|IPs less than 12 years old will receive either 2 mg/kg (if weight less than 20 kg) or 40 mg (if weight more than or equal to 20 kg) of Baloxavir Marboxil as oral suspension. IPs more than or equal to 12 years old will receive either 40 mg (if weight less than 80 kg) or 80 mg (if weight more than or equal to 80 kg) of Baloxavir Marboxil as tablets. HHCs of IPs will not receive study medication.
15859138|NCT03969212|Drug|Placebo|IPs less than 12 years old will receive placebo oral suspension and those above 12 years will receive placebo tablets. HHCs of IPs will not receive study medication.
15859139|NCT03969199|Behavioral|Intervention|Dietary intervention in coordination with MANNA, who will deliver low sodium meals to patients for 90 days
15859140|NCT03969186|Behavioral|Intervention|Telehealth intervention monitoring weight and medication adherence accompanied by a weekly phone call to monitor symptoms.
15859141|NCT03969173|Procedure|applying PEEP3|"The baseline atelectasis score is measured using sonography with no PEEP. And then, the baseline cardiac index is measured using transesophageal doppler for 5 minutes each with 3 cmH2O of PEEP.
~Apply PEEP (3 cmH2O) according to the patient's randomized group, and maintain the PEEP until the end of the operation."
15859234|NCT03968406|Radiation|Radiation Therapy|Undergo radiation therapy
15859235|NCT03968406|Drug|Talazoparib|Given PO
15859142|NCT03969173|Procedure|applying PEEP6|"The baseline atelectasis score is measured using sonography with no PEEP. And then, the baseline cardiac index is measured using transesophageal doppler for 5 minutes each with 3 cmH2O of PEEP.
~Apply PEEP (6 cmH2O) according to the patient's randomized group, and maintain the PEEP until the end of the operation."
15859143|NCT03969173|Procedure|applying PEEP9|"The baseline atelectasis score is measured using sonography with no PEEP. And then, the baseline cardiac index is measured using transesophageal doppler for 5 minutes each with 3 cmH2O of PEEP.
~Apply PEEP (9 cmH2O) according to the patient's randomized group, and maintain the PEEP until the end of the operation."
15859144|NCT03969160|Behavioral|Imaginal exposure|Imaginal exposure to mental imagery of phobic and neutral stimuli
15859145|NCT03969147|Device|ManMaxAirway oropharyngeal airway adjunct|Healthy volunteers will self-place the ManMaxAirway.
15859146|NCT03969147|Device|Guedel Oropharyngeal airway adjunct|Healthy volunteers will self-place the standard Guedel OPA.
15859147|NCT03969147|Device|No airway adjunct|Healthy volunteers will have no airway adjunct in place.
15859148|NCT03969134|Biological|ChAd63-KH|The vaccine will be injected intramuscularly into the arm.
15859149|NCT03969134|Other|Placebo|The placebo will be injected intramuscularly into the arm.
15859150|NCT03969121|Drug|Palbociclib|Palbociclib will be administered orally once a day for 21 days every 28-day cycle followed by 7 days off treatment
15859151|NCT03969121|Drug|Endocrine therapy|Pre- and peri-menopausal women will be receiving Ovarian Function Suppression (OFS) by either leuprorelin subcutaneous 3.75 mg q28days or goserelin subcutaneous 3.6 mg q28days plus tamoxifen 20 mg QD in 28-day cycles. Post-menopausal women will receive letrozole 2.5 mg QD in 28-day cycles.
15859152|NCT03969108|Drug|Indocyanine Green|ICG is a fluorescent dye which binds tightly to plasma proteins and becomes confined to the vascular system.
15859153|NCT03969095|Behavioral|Tongue Pressure Resistance Training|2 supervised sessions per week: Each session will be a maximum of one hour in length and will include: 1) 20 repetitions of maximum isometric presses (MIPs) with rapid rise in pressure at the anterior location. 2) 15 regular saliva swallows with the IOPI bulb in place. 3)15 effortful saliva swallows with the IOPI bulb in place. 4) 10 generalization tasks with mildly thick liquid and IOPI.
15859154|NCT03969082|Behavioral|Bibliotherapy|Students will read to patients during 30 minutes. They will read aloud and pause regularly to encourage patients to reflect on what is being read, on the thoughts the poem or book has stirred or on how the reading matter relates to their own lives.
15859155|NCT03969069|Device|MAPLe|Additional assessment with MAPLe
15859156|NCT03969056|Behavioral|Artificial Intelligence (AI) Activity|The intervention provides participants with an automated and personalized daily step goal intervention involving a sophisticated activity analytics algorithm using advanced statistics and machine learning.
15859157|NCT03969056|Behavioral|10,000 steps|The intervention provides participants with an automated daily 10,000 step goal intervention
15859158|NCT03969043|Other|MRI|"The MRI examination will consist of a series of acquisition scans:
~Scanning Scan: for positioning the functional volume of interest.
~Task Scans: for exploring cerebral activation in emotional and action appraisal tasks during viewing high and low arousal stimuli and a localizer task .
~Anatomical MRI: for analyzing the functional images, and measuring volumes of gray and white substances.
~Resting state functional scan: for exploring cerebral activation during a rest activity.
~Diffusion Tension Imaging: for measuring structural connectivity.
~Perfusion imaging: scan for ensuring good perfusion conditions
~All functional acquisitions will be performed in multi-slices in echoplanar mode using gradient echo sequences allowing the exploitation of the BOLD contrast."
15859159|NCT03969030|Other|PEBRA model|"The participants in the intervention clusters are offered the PEBRA model. In the PEBRA model the ART visit/refill is coordinated by the PE, as much as feasible according to the participants' preferences. Thus, the preferences of each participant are captured at enrolment and after a strict schedule thereafter. The PE conducts the preference assessment using a tablet-based application, called PEBRApp, accoring to a specific schedule. First, the participant will be asked his/her preference regarding different domains of DSD (see below) and this will be entered into the PEBRApp. Secondly, the chosen preferences are assessed regarding feasibility with specific questions, as not all preference options are available to everyone all the time. The preference assessment entails the following three domains of DSD:
~ART Refill
~SMS notifications
~Support"
15859160|NCT03969017|Drug|pegylated interferon (Peg IFN)α-2b|Participants in NAs+Peg IFN Group will be treated by Peg IFNα-2b （180ug per week, the dose will be changed to 135ug or 90ug per week during the treatment if patients could not tolerate the side effects of Peg IFNα-2b). Peg IFNα-2b treatment will be performed until HBsAg <0.05IU/ml, with a maximum duration of 48 weeks.
15859161|NCT03969017|Drug|Nucleoside （acid）analogue (NAs)|Both of NAs Group and NAs+Peg IFN Group will be treated with NAs as before enrollment.
15859162|NCT03969004|Drug|Cemiplimab|Intravenous (IV) infusion over 30 minutes
15859163|NCT03969004|Drug|Placebo|Intravenous (IV) infusion over 30 minutes
15859164|NCT03968991|Diagnostic Test|VISIODOL® (Diagnostic tool)|Tool for assessing pain in the blind subject (with congenital or acquired deficiency)
15859165|NCT03968978|Biological|Tezepelumab (APFS)|Tezepelumab subcutaneous injection, administered by Accessorized pre-filled syringe (APFS).
15859166|NCT03968978|Biological|Tezepelumab (AI)|Tezepelumab subcutaneous injection, administered by Autoinjector (AI) device.
15859167|NCT03968965|Device|3D MvIGS Spine Navigation|The 7D Surgical MvIGS spine navigation system is for spatial positioning and orientation of surgical instruments during pedicle screw implantation in patients undergoing posterior fixation in single or multiple levels. The surgical light containing the machine vision cameras is the sole luminaire during image guided surgery.
15859168|NCT03968965|Other|2D Fluoroscopy|Pedicle screws will be placed using 2D fluoroscopy as the intraoperative imaging modality.
15859169|NCT03968952|Other|SMARThealth Pregnancy|Education and Training package on high-risk pregnancies and the associated long-term cardiometabolic risks; An mHealth platform providing mobile decision support to Community Health Workers.
15859355|NCT03967392|Drug|Xylocaine|TREATMENT
15869471|NCT03885921|Drug|Atorvastatin|oral tablet
15859173|NCT03968926|Other|Arterial pressure management during circulatory support by VA-ECMO|Norepinephrine continuous infusion to maintain mean arterial pressure above 65 mmHg or at a higher level depending of the perfusion pressure targeted for the patient (mean arterial pressure between 65 and 85 mmHg)
15859174|NCT03968913|Drug|Anakinra injection|anakinra 150mg in 5milliliters of sterile saline will be injected into the knee joint
15859175|NCT03968913|Procedure|sterile saline injection|5 milliliters of sterile saline will be injected into the knee joint
15859176|NCT03968900|Behavioral|Sleep restriction condition|On day 1, participants will complete study assessments and will be fitted with an Actiwatch and instructed to continue a fixed time in bed (8 hours duration with no more than 20 min deviation) centered on habitual sleep (e.g., 11:00 p.m. to 7:00 a.m.). Naps will not be allowed. Following the one-week baseline sleep stabilization, participants will engage in the sleep restriction condition(4 hours, TIB [Time in Bed]; 1:00 a.m. to 5:00 a.m.). On the day of each sleep study, participants will be admitted to University of Alabama Birmingham (UAB) Highlands Hospital sleep unit at 7:00 p.m. and receive a hospital dinner and will be discharged after breakfast served at 8:00 a.m. After each discharge, participants' smoking withdrawals will be monitored. At 7:00 p.m., participants will be re-admitted to UAB Highlands sleep unit, repeating the same conditions on the first night.
15859177|NCT03968900|Behavioral|Sleep extension condition|sleep extension On day 1, participants will complete study assessments and will be fitted with an Actiwatch and instructed to continue a fixed time in bed (8 hours duration with no more than 20 min deviation) centered on habitual sleep (e.g., 11:00 p.m. to 7:00 a.m.). Naps will not be allowed. Following the one-week baseline sleep stabilization, participants will engage in the sleep extension condition (10 hours, TIB; 10:00 p.m. to 8:00 a.m.). On the day of each sleep study, participants will be admitted to University of Alabama Birmingham (UAB) Highlands Hospital sleep unit at 7:00 p.m. and receive a hospital dinner and will be discharged after breakfast served at 8:00 a.m. After each discharge, participants' smoking withdrawals will be monitored. At 7:00 p.m., participants will be re-admitted to UAB Highlands sleep unit, repeating the same conditions on the first night.
15859178|NCT03968887|Other|plasma oxidized low-density lipoprotein levels|Detection of plasma oxidized low-density lipoprotein levels
15859179|NCT03968874|Device|Light box therapy|The intervention is sitting in front of a lightbox for 1 hour in the morning upon waking up.
15859180|NCT03968874|Device|Negative Ion Generator|The intervention is sitting in front of a modified negative ion generator for 1 hour in the morning upon waking up.
15859181|NCT03968861|Drug|Xenon|Inhaled xenon gas given via purposely designed ventilator
15859182|NCT03968848|Drug|acalabrutinib|A 50-mg single oral dose of acalabrutinib will be administered.
15859183|NCT03968835|Other|Bacitracin|For the first 30 people, bacitracin will be applied and covered with xeroform and gauze.
15859184|NCT03968835|Other|Skin Graft|For the next 30 patients, the amputated composite skin and soft tissue unit will be thinned out to become a full thickness skin graft.
15859185|NCT03968822|Drug|Lidocaine 2% Injectable Solution, Lidocaine 1% Injectable Solution, Bupivacaine 0.25% injectable solution, Bupivacaine 0.5% injectable solution, saline, no injection -- Followed by IL 20% IV Bolus|3 mL of test solution followed by 1.5 mL/kg of IL 20% IV Solution
15859186|NCT03968822|Drug|Lidocaine 2% Injectable Solution, Lidocaine 1% Injectable Solution, Bupivacaine 0.25% injectable solution, Bupivacaine 0.5% injectable solution, saline, no injection -- Followed by Saline Bolus|3 mL of test solution followed by 1.5 mL/kg of Saline IV Solution
15859187|NCT03968809|Diagnostic Test|CardioFlux Magnetocardiography|All patients enrolled and receiving standard screening tests for CAD will undergo a 2 minute scan with MCG. It will be determined if MCG scanning can provide equal or superior accuracy to predict MACE than standard testing.
15859188|NCT03968796|Other|Transcutaneous Electrical Nerve Stimulation (TENS)|
15859189|NCT03968796|Other|Sham Transcutaneous Electrical Nerve Stimulation (TENS)|
15859190|NCT03968796|Other|Kinesio Taping|
15859191|NCT03968796|Other|Sham Kinesio Taping|
15859192|NCT03968783|Other|Monofilament suture|1.0 monofilament synthetic absorbable suture for closure of the low transverse uterine incision
15859193|NCT03968783|Other|Multifilament suture|1.0 multifilament synthetic absorbable suture for closure of the low transverse uterine incision
15859194|NCT03968770|Dietary Supplement|Experimental group|Probiotic (Lactobacillus casei) once daily taken by 6 weeks.
15859195|NCT03968770|Dietary Supplement|Control group|Placebo of Probiotic once daily taken by 6 weeks.
15859196|NCT03968770|Other|Usual medical care|NSAIDs, once daily taken and promotion of a healthy lifestyle by 6 weeks.
15859197|NCT03968757|Device|easyEndoTM Universal Linear Cutting Stapler and reloads (Ezisurg Medical)|Device for creation of anastomoses during laparoscopic RYGB surgery manufactured by Ezisurg Medical.
15859198|NCT03968744|Drug|Safinamide|Safinamide taken per Os for 12 weeks
15859199|NCT03968731|Other|Zocular Eyelid System Treatment|Zocular products contain okra-infused Zocusome micelles that gently lift and clear the oil, debris, and residue on eyelid margins. THerefore, the ZEST treatment is expected to improve signs and symptoms of Meibomian gland dysfunction (MGD) and reduce Contact lens discomfort associated with MGD.
15859200|NCT03968718|Behavioral|Systematic ePROMs Assessment|"Depending on the care setting, eligible patients will be asked to fill in one of the following e-PROMs assessment:
~Edmonton symptom assessment scale (ESAS-r) (outpatients)
~Distress Thermometer (inpatients)
~An ad hoc questionnaire adapted from the Bench-Can and EURACAN projects plus the institutional customer satisfaction survey (patients followed by multidisciplinary teams)"
15859201|NCT03968692|Diagnostic Test|Prostate-Specific Antigen test|Prostate-Specific Antigen (PSA) test as opportunistic screening or in the presence of symptoms
15859202|NCT03968679|Radiation|Unilateral elective nodal irradiation|After injection of nanocolloid tracer submucosally around the tumor, patients undergo lymph drainage mapping (LDM) using SPECT/CT. If no contralateral drainage is visualized, the patient receives unilateral elective nodal irradiation (ENI). In case of contralateral lymph drainage, a contralateral sentinel node procedure is performed. If pathologic evaluation finds no metastasis, the patient receives unilateral ENI. If (micro/macro) metastasis are found, the patient will receive bilateral ENI.
15859205|NCT03968640|Dietary Supplement|CoQ10|The intervention will consist of a loading dose of reduced form CoQ10 of 1,800 mg/day tid for 4 weeks to be followed by a maintenance dose of 600 mg/day once daily from weeks 5 to 12. The intervention or allocation-controlled placebo will be administered by 72 hours after injury and will continue until 12 weeks after injury or until death or discharge, whichever comes first. Oral tablets (600 mg/tablet) will be administered to CoQ10 subjects who can swallow while a liquid form (100 mg/mL) will be administered to CoQ10 subjects requiring an enteral tube for nutrition.
15859206|NCT03968640|Dietary Supplement|Placebo|The intervention will consist of a loading dose of reduced form CoQ10 of 1,800 mg/day tid for 4 weeks to be followed by a maintenance dose of 600 mg/day once daily from weeks 5 to 12. The intervention or allocation-controlled placebo will be administered by 72 hours after injury and will continue until 12 weeks after injury or until death or discharge, whichever comes first. Oral tablets (600 mg/tablet) will be administered to CoQ10 subjects who can swallow while a liquid form (100 mg/mL) will be administered to CoQ10 subjects requiring an enteral tube for nutrition.
15859207|NCT03968627|Other|Rehabilitative intervention|intensive multidisciplinar rehabilitation
15859208|NCT03968614|Other|Electric dry needling and conventional PT|Electrical Dry Needling, Eccentric Exercise, Stretching and Manual Therapy
15859209|NCT03968614|Other|Conventional PT|Eccentric Exercise, Stretching and Manual Therapy
15859210|NCT03968601|Other|Mitral regurgitation surgery such as mitral valve replacement or repair|Mitral regurgitation surgery such as mitral valve replacement or repair. All kind of mitral regurgitation surgery: replacement or repair, by median sternotomy of minimally invasive surgery, with or without tricuspid plasty
15859211|NCT03968588|Drug|Tacrolimus(reduced), Mycophenolate mofetil(standard)|tacrolimus target trough blood level: 3~8ng/mL MMF dose: 1.5~2g/d
15859212|NCT03968588|Drug|Tacrolimus(standard), Mycophenolate mofetil(reduced)|tacrolimus target trough blood level: 5~15ng/mL MMF dose: 0.5~1g/d
15859213|NCT03968575|Device|laser treatment|sub-threshold micro-pulse laser treatment
15859214|NCT03968562|Drug|2% Doxycycline Cream in Generic Aquaphor or Generic Aquaphor|2% Doxycline Cream in Generic Aquaphor or Generic Aquaphor will be applied topically twice during the study visit: first for 30 minutes, then for 6 hours duration.
15859215|NCT03968549|Dietary Supplement|Probiotic|Those patients in group Probiotic will receive the capsules containing Lactobacillus acidophilus and will need to take one of it everyday during the study.
15859216|NCT03968549|Other|Placebo|Those patients in group Placebo will receive the capsules containing vegetable oil and corn starch and will need to take one of it everyday during the study.
15859217|NCT03968536|Behavioral|fall prevention|Training in physiotherapy sessions and ergonomic home development
15859218|NCT03968523|Procedure|Novel local infiltration technique|Local analgesic infiltration in the mesh fixation site
15859219|NCT03968523|Procedure|TAP block|TAP block technique
15859220|NCT03968510|Procedure|parathyroidectomy|routine parathyroidectomy will be done for the treatment of adenoma
15859221|NCT03968497|Other|Postoperative pain assessment with female investigator|Postoperative pain evaluation by a female investigator by using visual analogue scale, numeric rating scale and Painmatcher®.
15859222|NCT03968497|Other|Postoperative pain assessment with male investigator|Postoperative pain evaluation by a male investigator by using visual analogue scale, numeric rating scale and Painmatcher®.
15859223|NCT03968484|Biological|platelet transfusion|Transfusion of platelets
15859224|NCT03968471|Behavioral|Scoring tool in Chemotherapy-induced necrosis in Ewing sarcoma|"The aim of the present study is to evaluate which is the best scoring tool to determine the histological response to chemotherapy in localized Ewing sarcoma of bone.
~The study will exam all the different systems to evaluate the histological necrosis after neo-adjuvant chemotherapy in all patients with localized Ewing sarcomas of bone surgically treated between 1982 and 2012."
15859225|NCT03968458|Behavioral|CON|. Control condition without exercise / rest condition. The adolescents will be asked to remain quiet and at rest during the morning and will receive an ad libitum meal at lunch and dinner times. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.
15859226|NCT03968458|Behavioral|EX-30|Condition with an acute exercise set 30 minutes before lunch The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling), 30 minutes before lunch. Lunch will be served ad libitum as well as diner. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.
15859227|NCT03968458|Behavioral|EX-90|condition with an acute exercise set 90 minutes before lunch. The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling), 30 minutes before lunch. Lunch will be served ad libitum as well as diner. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.
15859228|NCT03968445|Drug|[18F]DPA-714-PET/MRI|[18F]DPA-714-PET/MRI
15859229|NCT03968432|Behavioral|MIAS&Q|There were two interventions compared in this study: 1) Be Sweet to Babies Videos and Pamphlet; and 2) Be Sweet to Babies Videos, pamphlet, and MIAS&Q. The Be Sweet to Babies vaccination pain management videos and pamphlet were provided to all participants as this information is publicly available, and demonstrates the effectiveness of the evidence-based recommended vaccination pain management strategies for infants. In addition, a pamphlet was used which was developed in partnership with CHEO and Ottawa Public Health as a knowledge translation tool. Those in the intervention arm were also given MIAS&Q included five questions and statements based on the MI approach consisted of four scaled questions and two open-ended questions, aimed to present brief informative and affirmative questions and statements to help the parents reflect on their own thoughts and support them to advocate for the use of the recommended pain management strategies during their infant's vaccination.
15859230|NCT03968432|Behavioral|Be Sweet to Babies Videos and Pamphlet|The Be Sweet to Babies vaccination pain management videos and pamphlet will be provided to all participants. Be Sweet to Babies vaccination pain management videos showing parents how to use breastfeeding, upright secure holding, and a small volume of sweet solution during vaccination, will be used. This pamphlet is a knowledge translation tool previously developed in partnership with the Children Hospital of Eastern Ontario (CHEO) and Ottawa Public Health and has been publicly available on the Ottawa Public Health Website since June 2013. The content presented about pain management for infants during vaccination is the same information as the video.
15859231|NCT03968419|Drug|canakinumab|Administered subcutaneously
15859236|NCT03968393|Drug|Investigators can choose from one of four Non-vitamin K oral anticoagulants (NOACs): Edoxaban 60mg daily, Apixaban 5mg twice daily, Dabigatran 110mg twice daily, or, Rivaroxaban 20mg daily.|Daily administration from time of randomization to final follow-up
15859237|NCT03968380|Other|Population survey with biological and physical measurements.|Individuals will be interviewed in their homes by trained interviewers. At a later date, in a location agreed with the study team, a sample of blood will be taken and we will measure fasting glucose, cholesterol level and creatinine. We will measure participants' height, weight, waist circumference and blood pressure. An Oral Glucose Tolerance Test (OGTT) will be performed on non-diabetic and/or non-pregnant participants.
15859238|NCT03968367|Procedure|Magnetic activated sperm sorting|MACS is a technique which allows the spermatozoa with the best characteristics to be selected for use in assisted reproduction treatments. This technique removes apoptotic spermatozoa - those which will die without achieving fertilisation - and selects the healthy ones, thus increasing the possibility of pregnancy.
15859239|NCT03968354|Biological|"Collection of additional blood tubes; Biobanking (plasma, liver tissue)."|"Preservation of liver tissue obtain by liver biopsy, constitution of a collection
~Sampling of additional blood tubes for a biological collection (serum): Serum biomarker research and genetic research"
15859240|NCT03968341|Other|Pharmacokinetic and pharmacodynamic study of antibiotics used in severe endophthalmitis from samples taken from treated patients|"A 5mL dry tube will be taken by puncture of the humeral vein like a conventional blood test. This tube is not usually collected unless specifically requested by the ophthalmologist. This sample will be sent quickly (within two hours) to the CHNO Medical Biology Laboratory for centrifugation, serum separation and storage at -80°C.
~Samples stored at -80°C will be sent weekly to the Microbiology and Anti-infectives Laboratory at Hospital Paris Saint-Joseph, with the dosage request form duly completed with the usual information."
15859241|NCT03968328|Other|Interview|Take part in interview
15859242|NCT03968328|Other|Survey Administration|Respond to survey
15859243|NCT03968315|Procedure|Diaphragm Fluoroscopy|Undergo diaphragm fluoroscopy
15859244|NCT03968315|Procedure|Magnetic Resonance Imaging|Undergo MRI
15859245|NCT03968302|Drug|ARM A Triple therapy for helicobacter pylori|The triple regimen was defined as a combination of amoxicillin 1 gm twice a day, clarithromycin 500 mg twice a day and omeprazole is given in 40 mg twice a day dose.
15859246|NCT03968302|Drug|ARM B Quadruple therapy for helicobacter pylori|Quadruple therapy included colloidal bismuth subcitrate 240 mg twice daily,amoxicillin 1 gm twice a day, clarithromycin 500 mg twice a day and omeprazole is given in 40 mg twice a day dose.
15859247|NCT03968276|Other|use of digital tablet|"At the end of hospitalization, the patient has an educational tablet at his disposal for 1 month at home. Throughout its use, the patient may contact the investigating physician via a telephone number available within the application if he/she encounters a problem related to the study. At the end of this month, the patient must complete two questionnaires through the application to assess his or her knowledge of his or her condition and treatment, as well as his or her satisfaction with the use of the tablet.
~In this research, 1 month after inclusion, the patient will have an additional follow-up visit corresponding to a dedicated consultation in the vascular medicine department. It will allow the patient to review the use of the tablet and his or her satisfaction with the use of such a tool."
15859248|NCT03968263|Device|Hycon device(Routine protocol)|Hycon device will be activated half a turn every 3 days.
15859249|NCT03968263|Device|Hycon device(Modified protocol)|The activation period of the hycon device will be modified.
15859250|NCT03968263|Device|Hycon device(Routine protocol) and Vibration(Acceledent)|Hycon device will be activated half a turn every 3 days. Vibration will be applied 2 times 10 minutes per day.
15859251|NCT03968263|Device|Hycon device(Modified protocol) and Vibration(Acceledent)|The activation period of the hycon device will be modified. Vibration will be applied 2 times 10 minutes per day.
15859252|NCT03968250|Behavioral|Cognitive Behavioral Therapy for Treating Fatigue|"The internet-based CBT postcancer fatigue intervention includes two face-to-face sessions with their therapist and eight web-based treatment modules, each approximately 45 minutes in length, delivered over 6 months.
~The intervention will be specifically tailored to the individual needs of each patient: The CBT model of cancer-related fatigue distinguishes six perpetuating factors: 1) insufficient processing of being diagnosed with HL and being treated for it; 2) excessive fear of disease recurrence; 3) inactivity or a dysregulated (physical) activity pattern; 4) dysfunctional fatigue-related beliefs; 5) dysregulated sleep-wake pattern and 6) lack of social support. For each of these six cognitive-behavioural factors that can perpetuate fatigue a treatment module has been developed."
15859253|NCT03968237|Drug|Buprenorphine/Naloxone|Controlled substances
15859254|NCT03968224|Drug|Dapagliflozin/Metformin|Two tablets of Metformin 850 mg every 12 hours will be provided in combination with Dapagliflozin 10 mg per day. Each participant will receive diet and exercise intervention according to their BMI and current physical condition.
15859255|NCT03968224|Drug|Metformin|Two tablets of Metformin 850 mg every 12 hours will be provided. Each participant will receive diet and exercise intervention according to their BMI and current physical condition.
15859256|NCT03968211|Biological|Salmonella typhi polysaccharide vaccine|Salmonella typhi polysaccharide vaccine
15859257|NCT03968198|Drug|Autologous ASC (for Adipose-derived Stem/Stroma Cell)|After adipose tissue aspiration (liposuction) by an authorized person, ASCs were isolated and cultured during 14±2 days by the French Blood Establishment. Then, patients receive intramuscular injections of ASCs.
15859258|NCT03968185|Other|Interfascial infiltration|"Injection of L-bupivacaine (50 mg) and dexamethasone (4 mg) in the interfascial space under ultrasound guidance.
~Patients were kept under surveillance for at least one hour before discharge.
~Patients were discharged home with a 7 day supply of acetaminophen 1000 mg orally every 6 h, ketoprofen 100 mg, orally twice a day, and muscle relaxant as needed. Patients were instructed to take tramadol 50 mg, orally every 6h as needed for low back pain, in case of insufficient relief."
15859286|NCT03968003|Dietary Supplement|Inulin|Group A (intervention group) will receive inulin 10 g.Group B will receive placebo of isocaloric maltodextrin. Group C will receive dietary fiber advice aimed to match the recommended fiber intake for age.This study evaluates the changes of gut microbiota composition and diversity, body weight, body fat, SCFAs, plasma amino acids, satiety hormones (PYY and GLP-1), Inflammatory cytokines (IL-1β, TNF-α and IL-6) after 6-month studied period
15859450|NCT03966586|Behavioral|Usual clinical care and counseling|Usual clinical care and counseling
15859259|NCT03968185|Other|Standard medical treatment|"Standard medical treatment include acetaminophen, NSAIDs and muscle relaxant as first line pharmacological treatment and escalation to analgesics level II or morphine if required, as needed for low back pain, in agreement with national guidelines Route of administration (orally or iv) was let at the discretion of the attending emergency physician.
~Patients were kept under surveillance for one hour before discharge. Patients were discharged home with a 7 day supply of acetaminophen 1000 mg orally every 6h, ketoprofen 100 mg, orally twice a day, and muscle relaxant as needed. Patients were instructed to take tramadol 50 mg, orally every 6h as needed for low back pain, in case of insufficient relief."
15859260|NCT03968172|Behavioral|EBBC programme|"Web-based behavioural lifestyle intervention that provides patients with coordinated information based on their existing health beliefs, interests, etc. In the programme, techniques and exercises will be taught in sequentially active interactive learning units (simulated dialogues) and followed-up with email and SMS reminders in the second study year. The following topics will be focused on:
~Diagnosis and disease progression
~Support in disease processing
~Techniques for coping with stress and depressive symptoms as well as developing positive emotions
~Optimisation of dietary behaviour
~Optimisation of physical activity behaviour
~Sleep hygiene and methods for dealing with insomnia.
~The programme will accompany each patient with information material and e-mail reminders over a period of 12 months with initial 2-3 weekly tasks, later only weekly reminders and inputs every 2 weeks. All in all, the intervention programme will consist of 16 modules."
15859261|NCT03968172|Behavioral|Control group programme|"Web-based information platform with optimized standard care compiled from information material of the German Multiple Sclerosis Society (DMSG). Information will be provided in sequentially activated modules over a period of 12 months, covering the following topics:
~Disease progression
~Invisible symptoms of multiple sclerosis
~Symptomatic therapy
~Immunotherapy decision support
~Coping strategies
~Autonomy
~Fatigue
~Quality of life
~Physical activity
~Nutritional behaviour
~In addition, a reminder system with neutral e-mail reminders will be used to promote the use of the programme."
15859262|NCT03968159|Drug|Pimavanserin|Pimavanserin 34 mg (provided as 2×17 mg tablets) administered orally as a single dose once daily
15859263|NCT03968159|Drug|Placebo|Placebo (2×placebo tablets [size- and color-matched to pimavanserin]) administered orally as a single dose once daily
15859264|NCT03968146|Procedure|Erector Spinae Plane Block|The linear multi-frequency 6-13 megahertz transducer will be used. In the prone position,under aseptic conditions, the probe will be placed in a longitudinal position 2-3 cm lateral to the vertebral column. The transverse processes of the vertebrae at (mid) level of surgery, the Erector Spinae muscle and the psoas muscle are identified. A 22 gauge echogenic needle will be inserted in an in plane technique in a cephalad to caudad direction until bone contact with the top of the transverse process is reached. After slight retraction of the needle, A test dose of 5% dextrose in water can expand the fascial plane and confirm needle-tip location prior to injection of local anaesthetic. Then, 0.5 ml/kg of bupivacaine 0.25% with 0.1 mg/kg dexamethasone and adrenaline 1 : 200000 will be injected between erector spinea muscle and transverse process, taking in consideration not exceeding the toxic dose of bupivacaine; 4 mg/kg . the same procedure will be repeated on the contralateral side.
15859265|NCT03968146|Drug|Fentanyl|patients will receive an induction dose at 1 mcg/kg. If the analgesia was inadequate in the form of increase in heart rate and or arterial blood pressure by more than 20% of baseline values during surgery, this warrants the administration of intravenous fentanyl (0.5µg/kg).
15859266|NCT03968146|Drug|additional Fentanyl|patients will receive another dose of fentanyl 1 µg/kg 1 minute before start of skin incision.
15859267|NCT03968146|Drug|Morphine|After end of surgery and emergence from anesthesia, patients will receive continuous intravenous morphine with 0.03 mg/kg/hr.
15859268|NCT03968146|Drug|rescue Morphine|Morphine IV will be given as rescue analgesia (20 µg/kg) in all study groups if VAS pain score more than 3. The total maximum hourly morphine is 0.75 mg/kg/hr.
15859269|NCT03968146|Drug|pethidine|After reaching maximum hourly morphine and the patient is still in pain, pethidine will be used as a rescue at 0.5 mg/kg.
15859270|NCT03968146|Drug|Ketorolac|patients will receive IV ketorolac from the postoperative second day 15 mg q 6 hours, not to exceed 5 days.
15859271|NCT03968146|Drug|Acetaminophen|patients will receive postoperative IV acetaminophen IV 10 mg/ kg q 6 hours
15859272|NCT03968133|Dietary Supplement|Probiotic|Oral probiotic delivered in powdered form.
15859273|NCT03968133|Dietary Supplement|Placebo|Oral placebo delivered in powdered form.
15859274|NCT03968120|Other|Change of ventilatory settings|Change of Positive End-Exspiratory Pressure during one-lung ventilation
15859275|NCT03968107|Other|Reference ultrasound examination|Use of antenatal ultrasound examination to visualize and position the intestinal structures involved in digestive malrotation at high risk of volvulus and comparison to fetal MRI results.
15859276|NCT03968081|Behavioral|Cyberball|a ball tossing playing game in which the experimentor can control the number of throws received by the participants
15859277|NCT03968068|Procedure|Exercise Procedure|Patients will undergo 30 minutes of light-moderate intensity leg cycling, using the Letto-2 (Motomed, UK) in the semi-supine position.
15859278|NCT03968068|Procedure|Remote Ischaemic Conditioning|Patients will undergo 4 cycles of upper limb RIC using a blood pressure cuff. Each cycle will involve inflating the blood pressure cuff to 200 mmHg for five minutes around the upper arm, followed by a period of relaxation of the cuff for a further 5 minutes. The total RIC treatment time will take 40 minutes.
15859279|NCT03968055|Other|Integration with Epic|Participants will have CGM data connected to our medical record through an already established pathway (Dexcom app on iOS device to Apple HealthKit to Epic MyChart to Epic)
15859280|NCT03968042|Drug|Nerve Growth Factor|Intramuscular injection for 2 weeks
15859281|NCT03968042|Drug|Edaravone|Intravenous injection for 2 weeks
15859282|NCT03968042|Drug|Combination of vitamin B1, B6, C, E and mecobalamine|Medications of combination of vitamin B1, B6, C, E and mecobalamine for 6 months
15859283|NCT03968029|Procedure|suturing meniscal augmented|meniscal tear sutured + bone marrow injection/collagen membrane
15859284|NCT03968029|Procedure|suturing meniscal|meniscal tear sutured
15859285|NCT03968016|Device|SYSMEX HLSCL|Diagnostic device
15859287|NCT03967990|Other|Refined cornmeal flour|48 g/d of refined cornmeal flour served to participants as two daily 24 g servings via pita breads and/or muffins
15859453|NCT03966573|Other|Forms|Forms for evaluating quality of life, pain, function
15859288|NCT03967990|Other|50/50 refined cornmeal-bran mix|48 g/d of a mix of 50% refined cornmeal flour and 50% corn bran flour served to participants as two daily 24 g servings via pita breads and/or muffins
15859289|NCT03967990|Other|Whole grain cornmeal flour|48 g/d of whole grain cornmeal flour served to participants as two daily 24 g servings via pita breads and/or muffins
15859290|NCT03967977|Drug|Tislelizumab|200 mg administered Intravenously (IV) as specified in the treatment arm
15859291|NCT03967977|Drug|Placebo|Tislelizumab placebo to match
15859292|NCT03967977|Drug|Cisplatin|70 mg/m2 administered IV as specified in the treatment arm
15859293|NCT03967977|Drug|Gemcitabine Hydrochloride|1000 mg/m2 administered IV as specified in the treatment arm
15859294|NCT03967977|Drug|Carboplatin|Area Under the Curve (AUC) 4.5 administered IV as specified in the treatment arm
15859295|NCT03967964|Drug|Dehydroepiandrosterone 2.2 g|Vaginal ring with 2.2 grams DHEA.
15859296|NCT03967964|Drug|Dehydroepiandrosterone 1.5 g/Testosterone 25 mg|Vaginal ring with DHEA 1.5 grams/Testosterone 25 mg.
15859297|NCT03967964|Drug|Testosterone|Vaginal ring with 35 mg testosterone.
15859298|NCT03967964|Drug|Testosterone Topical Gel|Gel containing 1% testosterone.
15859299|NCT03967964|Drug|Dehydroepiandrosterone Oral Capsule|Capsule containing 25 mg DHEA
15859300|NCT03967951|Other|CT radiomic feature evaluation|"Radiomic features will be calculated and extracted from all contrast and non-contrast CT-scans. First order features will be evaluated and high order features will be grouped in parent matrices. Parent matrices of second and third order will be chosen and evaluated.
~In the second part, based on the results of inter-correlation of the operator analysis, the most significant radiomic features will be chosen. Morphological and histopathological features will be evaluated will be.
~Histopathology will be performed on a biopsy specimen; percentage of Ki67 and grading will be evaluated."
15859301|NCT03967938|Drug|Olaparib Oral Capsule|Olaparib tablets 300mg twice daily
15859302|NCT03967925|Drug|Belimumab|Sub-cutaneous injection
15859303|NCT03967925|Drug|Rituximab|IV infusion 1g x 2
15859304|NCT03967925|Drug|Prednisolone|20mg prednisolone tapering dose
15859305|NCT03967912|Behavioral|MOVE UP|Each of the 12 group sessions will focus on incremental behavioral strategies for maintaining healthy eating, activity, and weight loss.behaviors. Body weight will be measured in-person session and participants will also to measure their body weight on their in Session 3, participants are given physical activity goal of 10 minutes/day, 50 minutes/week. The goal is raised by 5 minutes/day, 25 minutes/week every other session, the final goal being 30 minutes/day, 150 minutes/week. All subjects will be recommended to engage in an energy restricted dietary intervention that evidence demonstrates has effectively reduced body weight by 5-7% within the initial 4 months of the intervention. This will include reducing energy intake to 1200 to 1800 kcal/d based on initial body weight (<200 pounds = 1200 kcal/d; 200 to 250 pounds = 1500 kcal/d; >250 pounds = 1800 kcal/d).
15859306|NCT03967886|Drug|YYD601 20mg|Patients should take drugs an hour before breakfast.
15859307|NCT03967886|Drug|Nexium 20mg|Patients should take drugs an hour before breakfast.
15859308|NCT03967886|Drug|Placebos|The placebo YYD601 is made from microcrystalline cellulose covered with hard shell. The placebo Nexium is made from microcrystalline cellulose, Crospovidone, Magnesiumstearat and other ingredients.
15859309|NCT03967860|Diagnostic Test|CT scan|Post surgical standard CT Scan as predictor of complication
15859310|NCT03967847|Drug|Ketorolac|Oral Ketorolac
15859311|NCT03967834|Other|Patient with Soft Tissue Sarcoma|"Tumor specimens will be collected for the study at diagnosis.
~A blood sample will be collected in all included patients at baseline, after the completion of the treatment (for patients included with a localized disease) or at the time of the first tumoral evaluation (for patients included with a metastatic disease), and at the time of progression.
~Patient's data (clinical, biological and disease data) will also be collected at baseline visit and then at each time point planned in the center for clinical benefit assessment (i.e. every 2 or 3 months) until progression or for a maximum duration of 5 years."
15859312|NCT03967821|Other|Questionnaire|Each patient complete FQoR-15 questionnaire 3 times (before surgery, on Day 1, on Day 2)
15859313|NCT03967795|Drug|N2-L-Alanyl-L-Glutamine (Substance)|20 gr of 10% N2-L-Alanyl-L-Glutamine, dilution in 200 ml of water for injection, intravenous perfusion over 30 minutes
15859314|NCT03967782|Behavioral|CON|Control condition without exercise / rest condition. The adolescents will be asked to remain quiet and at rest during the morning and will receive an ad libitum meal at lunch and dinner times. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.
15859315|NCT03967782|Behavioral|EX-MEAL|Condition with an acute exercise set right before lunch The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling) right before ad ad libitum lunch meal. Lunch will be served ad libitum as well as diner. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.
15859316|NCT03967782|Behavioral|MEAL-EX|. condition with an acute exercise set right after lunch. The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling) right after an ad libitul buffet meal. Lunch will be served ad libitum as well as diner. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.
15859317|NCT03967769|Device|High Flow nasal Cannula|Apnoeic Oxygenation by High Flow Nasal Cannulae
15859318|NCT03967756|Device|Automatic polyp detection system|When colonoscopists withdraw the colonoscopies and inspect the colons, the video streaming of colonoscopies was real-time switched to the automatic polyp detection system, which made it feasible to detect lesions in real time. When any potential polyp is detected by the system， there will be a tracing box on an adjacent monitor to locate the lesion with a simultaneous sound alarm.
15859319|NCT03967730|Combination Product|Sonodynamic therapy(SDT)|Sonodynamic Therapy (SDT) Sinoporphyrin Sodium (DVDMS) as sonosensitizer, is dissolved in 0.9% sodium solution for following skin test and intravenous injection. 0.01mg/ml DVDMS solution (0.1ml) is prepared for skin test followed by 0.04 mg/ml DVDMS solution intravenous injection(0.2mg/kg).The target atherosclerotic lesions are marked on the corresponding skin with ultrasound guidance and underwent ultrasound exposure after 4 hours incubation. The therapeutic ultrasonic transducer is fixed to the marked skin site for 15 min of each lesion. Ultrasound parameters included intensity of 2.1W/cm2 for each lesion, resonance frequency: 1.0 MHz and duty factor: 30%.
15859320|NCT03967717|Other|Characterization of parameters of medical history, examination and diagnostics.|Patients receive standard of care diuretics. The study only collects data to characterize parameters of medical history, examination and diagnostics.
15859321|NCT03967704|Procedure|Life quality evaluation|As part of this research, 2 additional consultations at 12 months and 24 months will be carried out by one of the rheumatologists in the department. At the consultation 12 months after his inclusion, the patient will have a clinical examination, a quality of life questionnaire to complete and additional images (x-rays). For the 24-month consultation, the patient will have a clinical examination, a quality of life questionnaire to complete and the patient may have an additional X-ray of the spine if there is height loss > 2 cm and/or pain.
15859322|NCT03967691|Drug|Tocilizumab infusion|Tocilizumab (8mg/kg body weight diluted to 100 ml NaCl 0.9%) will be infused over 1 hour
15859323|NCT03967691|Drug|Saline 0.9%|100 ml NaCl 0.9% will be infused over 1 hour
15859324|NCT03967678|Dietary Supplement|Three portions per week (690g beef (raw weight)) for 5 weeks|Lunches served in Human Intervention Studies Unit
15859325|NCT03967665|Drug|N-acetyl-L-cysteine|NAC 400 mg three times per day from -14D pre-HSCT to +2 months post-HSCT
15859326|NCT03967652|Diagnostic Test|Nanomaterial-based sensors|Chemical sensors based on Monolayer-Capped Metallic Nanoparticles (MCMNPs) can recognize and classify exhaled breath by special recognition algorithm, which achieves the purpose of disease diagnosis.
15859327|NCT03967639|Procedure|Elective cardiac surgery|Elective cardiac surgery
15859328|NCT03967626|Device|external cooling with the xxxxx device|external cooling with the xxxxx device
15859329|NCT03967613|Device|Functional eletrical stimulation|Aplication of functional eletrical stimulation on contralesional upper limb during functional tasks
15859330|NCT03967587|Device|Neosense Umbilical Catheter|The Neosense umbilical catheter is used instead of the routinely used umbilical catheter
15859331|NCT03967574|Device|Transcranial direct current stimulation|"The tDCS anode was applied on the primary motor cortex area responsible for the control of the rotator cuff, as determined using transcranial magnetic stimulation and surface electromyography. The cathode was applied on the contralateral forehead, just above the eyebrow. The electrodes were soaked in saline solution to improve conductivity and the montage was secured with rubber bands and adhesive tape.
~The tDCS device (Soterix Medical 1x1 tDCS device) was then gradually turned to an intensity of 2mA. This stimulation was continued for a total of 20 minutes, after which it was gradually stopped."
15859332|NCT03967561|Other|Progressive water-based aerobic training|The intervention will comprise walking/running in shallow pool with progression in the training variables. The training will have 12 weeks of duration with 3 weekly sessions (of 50 minutes each).
15859333|NCT03967561|Other|Non-progressive aerobic training|The intervention will comprise walking/running in shallow pool without progression in the training variables. The training will have 12 weeks of duration with 3 weekly sessions (of 50 minutes each).
15859334|NCT03967548|Drug|Germinal peptide eye drops|Germinal peptide eye drops of 0.004%
15859335|NCT03967535|Device|MRI Brain Imaging|Up to two Magnetic Resonance Imaging (MRI) scan sessions will be done, altogether totaling just under 3 hours of scanning. MR scanners measure brain anatomy and activity using very strong magnets. No X-rays or radiation are involved.
15859336|NCT03967535|Behavioral|Mental Health Assessment and Computerized Cognitive Test|Participants will be asked to complete questionnaires and will be asked questions that address a broad range of personal life experiences involving social, occupational, domestic, and other behaviors.
15859337|NCT03967522|Drug|Cabozantinib|All participants will be treated by 60 mg of cabozantinib once daily. Temporary or permanent discontinuation and/or dose reduction of cabozantinib therapy may be required for the management of some adverse reactions. When dose reduction is necessary, it is recommended to reduce to 40 mg daily, and then to 20 mg daily.
15859338|NCT03967509|Behavioral|Comet|
15859339|NCT03967496|Procedure|Types of Anesthesia|"General Anesthesia includes: Inhalational anesthesia and total intravenous anesthesia.
~Regional blocks includes: Spinal Anesthesia, Epidural Anesthesia, Plexus Block, Peripheral Nerve Block,... etc Monitored Anesthesia Care: No anesthetic administered but care given for hemodynamic and blood sugar control intraoperatively."
15859340|NCT03967496|Procedure|Access of Surgery|Type of surgical access
15859341|NCT03967496|Other|Comorbidities|A patient may have more than one comorbidity
15859342|NCT03967496|Drug|Preoperative Medication|Preoperative medications
15859343|NCT03967496|Diagnostic Test|Routine blood test|Preoperative and Intraoperative Investigations
15859344|NCT03967483|Drug|Indometacin|patient who are taken indomatacin for headaches and migraine
15859345|NCT03967470|Biological|Bacterial spray|Bacterial spray containing bacteria that do not cause underarm malodor
15859346|NCT03967457|Diagnostic Test|questionnaires survey|Including four kinds of questionnaires: European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 (V3); EORTC QLQ-CX24; Eligibility Criteria (FSFI); and Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFIQ-7)
15859347|NCT03967457|Diagnostic Test|Urodynamic testing|"Urodynamic testing consists of important urodynamic parameters including:
~Bladder capacity at the first void sense Bladder capacity at normal desire to void Bladder capacity at strong desire to void Qmax Qave Pves at Qmax Pdet at Qmax Cves at SDV Cdet at SDV Residual urine volume"
15859348|NCT03967457|Diagnostic Test|Rectum dynamics testing|Rectum dynamics testing consists of important parameters of rectum activities
15859349|NCT03967457|Diagnostic Test|ovarian reserve function|"Testing for ovarian reserve function consists of:
~Follicle-stimulating hormone Estradiol Anti-mullerian hormone Inhibin B"
15859350|NCT03967444|Device|Hyaluronic acid|Injectable gel for lip augmentation
15859351|NCT03967444|Device|Hyaluronic acid|Injectable gel. Lip Augmentation and other wrinkles/folds
15859352|NCT03967431|Other|Narrative Enhancement and Cognitive Therapy (NECT)|Narrative Enhancement and Cognitive Therapy includes two introduction meetings, three psychoeducation meetings, seven cognitive restructuring meetings, seven narrative enhancement meetings and one summing up meeting.
15859353|NCT03967418|Behavioral|Cognitive and clinical assessment|The content of the assessment will be the same for all subjects and will consist of a cognitive assessment (neurocognition, social cognition, metacognition, emotional reactivity) and a clinical assessment (impulsivity, personality, psychiatric and addictive comorbidities)
15859356|NCT03967379|Behavioral|Mobile App + enhanced standard care|An intervention to help address sexual dysfunction among HCT survivors
15859357|NCT03967379|Other|Enhanced Standard Care|Standard of care administered by the institution
15859358|NCT03967353|Behavioral|New management mode intervention|"Patients in routine treatment group use TB assistant APP. Medical staff strengthen health promotion of the patients,including, infection control, doctor-patient communication, etc."
15859359|NCT03967327|Drug|Buprenorphine transdermal patches|It should be applied to non-irritated, intact skin of the upper outer arm, upper chest, upper back or the side of the chest. The skin should be relatively hairless. If none are available, the hair at the site should be clipped, not shaven.
15859360|NCT03967327|Drug|Morphine Sulfate Sustained-Release Tablet|It will be administered orally twice (q12h) daily.
15859361|NCT03967314|Other|TLIP block group (group T)|In group T, the block was performed bilaterally under aseptic conditions using the US device with a high-frequency 12-MHz linear US probe. The probe was covered with a sterile sheath and placed vertically at the L3 vertebrae level. After visualizing the hyperechoic shadow of the spinous process and interspinous muscles as an anatomical guide point, the probe was moved forward in a lateral direction to visualize the longissimus and iliocostal muscles. Using the in-plane technique, a 22-G, 50-mm block needle was inserted between the muscles in a medial-to-lateral direction in the interfascial plane. Once the needle tip was placed within the interfacial plane and after careful aspiration to rule out intravascular needle placement, 2 ml of saline was injected to confirm the accuracy of the injection site. A dose of 0.25% bupivacaine (20 ml) was then injected in each side (total 40 ml).
15859362|NCT03967314|Other|Wound infiltration group (group W)|In group W, a dose of 0.5% bupivacaine (20 ml) was injected for wound infiltration into the surgery site.
15859363|NCT03967301|Dietary Supplement|Probiotic|Intervention: defined as probiotic consumption
15859364|NCT03967301|Dietary Supplement|Placebo|Placebo consumption. The placebo will be provided by the company that produces the probiotic.
15859365|NCT03967288|Drug|Chloroprocaine Injection [Clorotekal]|1% chloroprocaine Hydrochloride Injection (50 mg/5 mL) for intrathecal use
15859366|NCT03967288|Drug|Bupivacaine Hydrochloride 0.75% Injection Solution|0.75% bupivacaine Hydrochloride injection in 8.25% dextrose for intrathecal use
15859367|NCT03967275|Other|bone marrow harvest|During bone marrow harvest, an additional 10 mL sample will be collected for the study.
15859368|NCT03967262|Behavioral|Brief Motivational Intervention|The objective of motivational intervention is to make the patient aware of the relationship between the consumption of alcohol and other drugs and the accident, and induce them to carry out a change in habits.
15859369|NCT03967249|Drug|IONIS GHR-LRx|IONIS GHR-LRx subcutaneous injection
15859370|NCT03967249|Drug|SRL|Participants will receive SRL once monthly
15859371|NCT03967236|Other|Collection of stool and blood samples|"For each visit, stool and blood samples will be collected during a pediatric gastroenterology day hospital stay.
~This collection of stool and blood specific IVOIRE study is carried out in the context of examination already planned for the usual care of the patient."
15859372|NCT03967223|Drug|Letetresgene autoleucel (lete-cel, GSK3377794)|letetresgene autoleucel will be administered.
15859373|NCT03967223|Drug|Fludarabine|Fludarabine will be used as the lymphodepleting chemotherapy
15859374|NCT03967223|Drug|Cyclophosphamide|Cyclophosphamide will be used as the lymphodepleting chemotherapy.
15859375|NCT03967197|Drug|Saline spray|Physiologic saline spray
15859376|NCT03967197|Drug|Lidocaine Hydrochloride|Lidocaine hydrochloride 10% spray
15859377|NCT03967171|Other|before uterine incision oxytocin|blood loss during elective cesarean section
15859378|NCT03967171|Other|after clamping the umbilical cord oxytocin|blood loss during elective cesarean section
15859379|NCT03967158|Device|Xience Sierra stent|Percutaneous coronary intervention with Xience Sierra stent
15859380|NCT03967145|Behavioral|Determining quality of life|Quality of Life
15859381|NCT03967132|Other|Control Infant Formula|Ready to feed infant formula, feed ad libitum
15859382|NCT03967132|Other|Experimental Infant Formula|Ready to feed infant formula, feed ad libitum
15859383|NCT03967132|Other|Reference Group|Human milk, breast feeding ad libitum
15859384|NCT03967119|Device|Patient monitoring|Arterial blood pressure, pulse oxygen saturation, and cardiac output/stroke volume are monitored with invasive arterial catheter, pulse oxymetry, and esophageal doppler in all participants. Some dynamic variables including SVV and PPV are automatically calculated in each monitor. PWV is manually calculated in a printed plethysmographic waveform. Plethysmographic waveform amplitude (PW) is measured on a beat-to-beat basis as the vertical distance between peaks and preceding valley troughs in the waveform. The maximum PW (PWmax) and minimum PW (PWmin) are determined manually over the same respiratory cycle, and PWV is calculated. PWV=(PWmax-PWmin)/[(PWmax+PWmin)/2].
15859385|NCT03967106|Other|Ischaemic Preconditioning|IPC to the upper arm using a manual blood pressure machine with cuff. Three cycles of 5 minute cuff inflation to 30mmHg above the systolic blood pressure (BP) followed by 5 minute cuff deflation.
15859386|NCT03967106|Other|Sham|Sham intervention to the upper arm using a manual blood pressure machine with cuff. Three cycles of 5 minute cuff inflation to 30mmHg below the diastolic blood pressure (BP) followed by 5 minute cuff deflation.
15859387|NCT03967093|Drug|BXQ-350|BXQ-350 is a novel anti-neoplastic therapeutic agent configured from two components: Saposin C (SapC), an expressed (human) lysosomal protein, and the phospholipid dioleoylphosphatidyl-serine (DOPS), a phospholipid located on cell membranes (clinical formulation BXQ-350). BXQ-350 is administered by intravenous (IV) infusion over a minimum of six 28-day cycles.
15859388|NCT03967067|Procedure|liver resection|Open or laparoscopic, major or minor hepatectomy performed using the clamp-crush technique and intermittent clamping of hepatic pedicle
15859389|NCT03967054|Drug|Ivermectin|Ivermectin (6 mg tablet) given monthly from July-October each rainy season as a 3-day course of approximately 300 mcg/kg/day as estimated by height bands.
15859390|NCT03967054|Drug|Placebo oral tablet|placebo in the same size, color and shape at the ivermectin tablet
15859391|NCT03967041|Diagnostic Test|radiological defined sarcopenia|Evaluation for sarcopaenia was performed via calculating psoas cross-sectional area at level of L3 and normalising for height
15859392|NCT03967028|Procedure|cesarean section|lower segment cesarean section either elective or emergency
15859454|NCT03966560|Drug|Brimonidine Tartrate|Brimonidine tartrate 0.15% 1 eye drop, every day for 6-months
15859393|NCT03967015|Other|Maternal Administered Malnutrition Monitoring System (MAMMS)|Participants randomized to the MAMMS arm will be provided with two insertion MUAC tapes that are UNICEF color coded and numbered to 1 mm gradations to take home with them. Participants will receive a weekly SMS asking them to measure and send their child's MUAC via SMS. SMS messages will provide actionable reminders to measure and send the child's MUAC. Both the SMS sent to the participant and SMS responses sent by the participant to the MAMMS system will be free of charge. Study staff will screen all SMS measurements returned to the MUAC system for identification of malnutrition.
15859394|NCT03967002|Procedure|Test group with corticotomy surgery|"The surgery of corticotomy is performed with a piezo electric device and a personalized surgical guide just before the placement of orthodontic appliance. The initial impressions of the patient's dental arch as well as its three-dimensional radiography (CBCT) are used to create a perfectly adapted guide for minimally invasive corticotomy surgery.
~The incisions are made between the roots of:
~the second premolars and first premolars,
~the first lower premolars and canines,
~the canines and lateral incisors,
~the lateral incisors and central incisors, and,
~the two lower central incisors."
15859395|NCT03966989|Behavioral|Performance Feedback|Performance feedback offline that benchmarks providers' own performance to that of their peers
15859396|NCT03966976|Device|ECG monitoring & record|This is a mobile ECG recorder that not only records short portions of ECG on one or three leads, but also stores, processes and transmits their data to facilitate the diagnosis and to confirm the occurrence of AF arrhythmia episodes by the physician.
15859397|NCT03966976|Other|Conventional follow-up|Conventional follow-up
15859398|NCT03966963|Behavioral|Eye Movement Desensitization Reprocessing (EMDR)|Trauma-Focused Therapy
15859399|NCT03966950|Dietary Supplement|melatonin|melatonin 10 mg per os in the preoperative night and the immediate postoperative night and the first and second postoperative nights.
15859400|NCT03966950|Drug|Placebo oral tablet|placebo taken per os in the preoperative night and the immediate postoperative night and the first and second postoperative nights
15859401|NCT03966937|Other|Dry needling|"Hot Pack will be applied on Quadriceps muscles before session for general relaxation for 7-10 minutes. Stretching of quadriceps femoris muscle with 4 repetitions and 15 second hold per session will be performed. Strengthening exercises of 3 sets of 10 RM with progressive loading per session will be performed.
~Then after wearing gloves and appropriate personal protective measures, a thin filiform needle will be inserted which will penetrate into the skin and stimulate underlying myofascial trigger points."
15859402|NCT03966937|Other|Control|Hot Pack will be applied on Quadriceps muscles before session for general relaxation for 7-10 minutes. Stretching of quadriceps femoris muscle with 4 repetitions and 15 second hold per session will be performed. Strengthening exercises of 3 sets of 10 RM with progressive loading per session will be performed.
15859403|NCT03966924|Device|Rotational fractional resection (1.5mm Diameter Device)|Single treatment of skin resection and with and without focal lipectomy (removal of loose skin and fat)
15859404|NCT03966911|Device|Guardian™ Sensor (3) connected to a Guardian™ Connect Transmitter|Continuous Glucose Monitoring and frequent sample testing
15859405|NCT03966898|Drug|SHR6390 Tablets|SHR6390 Tablets
15859406|NCT03966898|Drug|Placebo Tablets|Placebo Tablets
15859407|NCT03966898|Drug|Letrozole or Anastrozole Tablets|Letrozole or Anastrozole Tablets
15859408|NCT03966885|Behavioral|Brief Intervention|The BI used in the trial combines motivational interviewing skills with cognitive behavioral therapy elements in order to assist clients with self identified substance misuse to begin to consider changing their rates of drinking and drug use. The intervention lasts 30 to 40 minutes and consists of 5 components including: 1) screening 2) identification and information on the impacts of substance misuse 3) talking about change and goal setting 4) understanding the primary reason for drinking 5) skill building with practice and 6) referral for services.
15859409|NCT03966885|Behavioral|Common Elements Treatment Approach (CETA)|The Common Elements Treatment Approach, or CETA, is a transdiagnostic psychotherapy based on cognitive behavioral elements for mood, anxiety and trauma related problems, and for alcohol and substance misuse. CETA is based on the fact that most evidence-based mental health treatments (EBTs) consist of similar components. The objective of CETA is to provide a single training in a range of therapy components that are similar across EBTs and to then teach counselors how to design a specific course of treatment for each client based on the client's presenting problems.
15859410|NCT03966872|Behavioral|Integrated Illness Management and Recovery|Education and skills training groups on illness management of chronic medical and psychiatric illness. Subsample of 75 will also receive COVID-specific Integrated Illness Management and Recovery module.
15859411|NCT03966872|Behavioral|Chronic Disease Self-Management Program|Education and skills training groups on illness management of chronic conditions
15859412|NCT03966859|Drug|Atorvastatin 20mg|oral dose, once daily for 7 days
15859413|NCT03966859|Other|Lactose placebo|oral dose, once daily for 7 days
15859414|NCT03966846|Dietary Supplement|Kefir|
15859415|NCT03966846|Dietary Supplement|Milk|
15859416|NCT03966833|Behavioral|IPT-G|14 weeks of group-based interpersonal therapy (IPT-G)
15859417|NCT03966833|Behavioral|Unconditional Cash Transfer|Lump sum cash transfer
15859420|NCT03966794|Device|Epidural Electrical Stimulation|Participants had finished the previous clinical trial with functional neural regeneration collagen scaffold transplantation, and will receive epidural electrical stimulation of the spinal cord in this group.
15859421|NCT03966794|Combination Product|Functional scaffold & Epidural Electrical Stimulation|Participants with acute complete SCI or chronic complete SCI will receive functional neural regeneration scaffold transplantation and epidural electrical stimulation of the spinal cord.
15859451|NCT03966573|Radiation|Radiographic imaging|Evaluating arthritis in knee and hip bilaterally. Evaluating axis deficiancy and leg length discrepancy.
15859452|NCT03966573|Other|Evaluating function|Test function and physical capasity
15859633|NCT03965208|Drug|Bivalirudin|titrated continuous infusion
15859422|NCT03966781|Procedure|ESWL|ESWL will be conducted under epidural anesthesia. For epidural anesthesia, bupivacaine will be used to block the T6-T12 spinal segments. The patient's eyes will be lightly covered all along the procedure. Once epidural anesthesia is achieved, the patient will be given a light sedation and ESWL will be performed using a Dornier dual focus lithotripsy system providing a maximum of 5000 at the rate of 90 shocks per minute in over 1-2 days.
15859423|NCT03966781|Procedure|ERCP|Once ESWL is over, an endoscopic pancreatic sphincterotomy will be performed and complete stone removal will be attempted with subsequent stenting of the pancreatic duct in the presence of a pancreatic stricture (not detected on MRCP prior to enrolment) or in case of incomplete stone removal
15859424|NCT03966781|Procedure|Sham ESWL|In the sham/control group, patients will be given a transient superficial pin-prick sensation to give the feel of epidural anesthesia. After that the lithotripsy machine the will be switched on, without establishing any form of contact with the patients body.
15859425|NCT03966781|Procedure|Sham ERCP|Following sham ESWL patientswill be subjected to sham ERCP to examine the papillary area, but no pancreatic ductal intervention will be performed.
15859426|NCT03966768|Device|Duramesh suturable mesh for laparotomy closure|Patients undergoing laparotomy will be closed with Duramesh suturable mesh
15859427|NCT03966768|Device|Conventional suture for laparotomy closure|Patients undergoing laparotomy will be closed with conventional polydiaxonone suture
15859428|NCT03966755|Behavioral|UFA dietary recommendations|The face-to-face intervention will be performed by a research nutritionist that reviews the dietary recall and provides a list of commonly available foods rich in unsaturated fatty acids (UFA) (monounsaturated fatty acids (MUFA) and polyunsaturated fatty acids (PUFA)), together with individual instructions on how to integrate the recommended foods in the daily dietary pattern based on the dietary recall, and also to emphasize that the recommended food should be consumed as listed, and not as part of processed food (i.e., guacamole for avocado, hazelnut chocolate for nuts, pesto for olive oil, fish sticks for fatty fish). Extra-virgin olive oil or canola oil or nuts will be considered first choice for daily consumption of UFA-rich food, but a list of daily food substitutes will be also provided .
15859429|NCT03966742|Procedure|Drug Eluting Bead Embolization (DEB) for Desmoid Fibromatosis|"Delivery of Doxorubicin selectively into Desmoid Fibromatosis utilizing its vascular supply as a conduit, and ionic loading the doxorubicin onto embolized particles as the drug delivery vehicle.
~Maximal dose is 75 mg/m2 and at least 50 mg. The bead size is 75-300 Mµ in a 2 CC syringe."
15859430|NCT03966729|Other|Time (outcome)|
15859431|NCT03966716|Device|Arthroplasty|Patients with an undisplaced femoral neck fracture receive a hemi or total hip arthroplasty depending on each hospital's routine for patient age and mobility.
15859432|NCT03966716|Device|Internal Fixation|Patients with an undisplaced femoral neck fracture undergo a closed reduction and internal fixation with 2-3 screws or pins, or sliding hip screw device. Type of fixation depends on each hospital's routine.
15859433|NCT03966703|Behavioral|mixing analysing test|The chewed gum is retrieved scanned and weighted to quantify masticatory efficiency
15859434|NCT03966690|Device|Isokinetic leg extension/-flexion on a legpress device|Maximum strength and rate of leg-flexion /-extension during legpress exercise
15859435|NCT03966690|Device|Isokinetic leg extension/-flexion on a legcurl device|Maximum strength and rate of leg-flexion /-extension during legcurl exercise
15859436|NCT03966664|Diagnostic Test|In vitro determination the dissociation constant (Ka) and total amount of non-volatile buffers (Atot) in isolated plasma.|Collection of a venous blood sample, centrifugation in order to harvest isolated plasma and performance of in-vitro tonometry in order to assess Ka and Atot.
15859437|NCT03966664|Diagnostic Test|In vitro determination the dissociation constant (Ka) and total amount of non-volatile buffers (Atot) in whole blood|Collection of a venous blood sample and performance of in-vitro tonometry in order to assess Ka and Atot.
15859438|NCT03966664|Diagnostic Test|Biomolecular analysis of plasma proteins.|Bidimensional electrophoresis, determination of oxidized albumin fraction, characterization of altered ligand binding properties of plasma albumin.
15859439|NCT03966651|Drug|PRRT with 177Lu-DOTATATE|Children will receive 2 Peptide Receptor Radionuclide Therapy (PRRT) using 177Lu-DOTATATE administered intravenously at 6 weeks interval.
15859440|NCT03966638|Procedure|Intra-meniscal injection of platelet-rich plasma|Intra-meniscal injection of platelet-rich plasma under echographic control
15859441|NCT03966625|Diagnostic Test|tissue transglutaminase autoantibodies|celiac disease-specific autoantibodies
15859442|NCT03966612|Other|Questionnaires|"Questionnaires about:
~Socio-professional situation
~Lifestyle
~Health
~NME 1
~specific breast cancer survey
~Imaging"
15859443|NCT03966599|Diagnostic Test|Pain|Patient's pain in order to VAS
15859444|NCT03966599|Diagnostic Test|Hemodynamic changes|changes in hemodynamic states
15859445|NCT03966586|Behavioral|Active outreach|Participants will get bidirectional weekly SMS messaging / automated voice messaging (depending on literacy), with messages to be programmed by the participant in the enhanced counseling sessions.
15859446|NCT03966586|Behavioral|Appointments|Participants in the enhanced-care intervention will be given specific appointment times/dates.
15859447|NCT03966586|Behavioral|Financial support|Participants in the enhanced-care intervention will receive free clinic visits, labs, and medications. They will also receive transportation incentives on a sliding scale based on distance to clinic, to range between 200-700 INR to be given each clinic/study visit. All participants, in both the usual care and enhanced care arms, will be offered VL testing free of charge, although this will not be known to the participants prior to the visit.
15859448|NCT03966586|Behavioral|Microenterprise|YRG CARE is affiliated with two microenterprise programs in bag-making and food-vending which can be leveraged as part of an intervention, particularly for women. There is an established training and mentoring program for individuals who wish to join the bag-making or food-making ventures. Participants who opt for this will be linked to the bag-making and food-vending programs, with all up-front costs (e.g. vending kiosk, training, serving materials, etc.) covered.
15859449|NCT03966586|Behavioral|Enhanced counseling|Participants in the enhanced-care intervention will participant in an individual enhanced counseling program called Steps to Success, based upon a Life Steps and Problem Solving curriculum. Steps to Success will consist of five one-on-one sessions of approximately 1 to 1.5 hours each. The first session will take place at the time of the participant's second clinical visit to YRG CARE, which will be between 1-3 weeks after the participant is recruited.
15859455|NCT03966560|Drug|Dorzolamide (as Dorzolamide Hydrochloride) 20 Mg/mL and Timolol (as Timolol Maleate) 5 Mg/mL Eye Drops|Dorzolamide and timolol fixed combination 2 eye drops, every day for 6 months
15859456|NCT03966560|Drug|Brinzolamide/Timolol 10 MG/1 ML-5 MG/1 ML Ophthalmic Suspension|Brinzolamide and timolol fixed combination 2 eye drops, every day for 6 months
15859457|NCT03966560|Drug|Travoprost and Timolol|Travoprost and Timolol fixed combination 1 eye drop, every day for 6 months
15859458|NCT03966560|Drug|Bimatoprost and Timolol|Bimatoprost and Timolol fixed combination 1 eye drop, every day for 6 months
15859459|NCT03966560|Drug|Latanoprost|Latanoprost 0.005% 1 eye drop, every day for 6 months
15859460|NCT03966547|Procedure|Ganglion sphenopalatine block with local anesthetic administered on study GSPB-2018|Block performed with bilaterally inserted q-tips with 1:1 mixture of lidocaine 40mg/ml and ropivacaine 5mg/mL as per GSPB-2018.
15859461|NCT03966547|Procedure|Ganglion sphenopalatine block with placebo administered on study GSPB-2018|Block performed with bilaterally inserted q-tips with isotone NaCl as per GSPB-2018.
15859462|NCT03966534|Other|Blood diversion|Diversion of initial blood obtained at venipuncture to biochemistry tube in order to try and reduce incidence of blood culture contamination
15859463|NCT03966508|Procedure|High-frequency electrical stimulation|High-frequency stimulation will be applied on the volar forearm (6-10 cm distal to the cubital fossa). To avoid any confounding effect of handedness, the arm onto which HFS will be applied twice (dominant vs nondominant) will be counterbalanced across participants. HFS will consist of 12 trains of 42 Hz electrical pulses lasting 1 s each. The time interval between each train will be 10 s. The intensity of stimulation will be 5mA. Electrical pulses will be delivered to the skin using a specifically-designed electrode designed: the cathode consists of 16 blunt stainless-steel pins with a diameter of 0.2 mm protruding 1 mm from the base. The 16 pins are placed in a circle with a diameter of 10 mm. The anode consists of a surrounding stainless-steel ring having an inner diameter of 22 mm and an outer diameter of 40 mm. This procedure induces secondary pinprick hyperalgesia (an increase in pinprick sensitivity in a large area of the skin).
15859464|NCT03966495|Other|Sustainability of a research program in risk management|"No intervention will be implemented in the present study.
~The investigators will evaluate of the sustainability of a research program in risk management in pluriprofessional primary care offices:
~Qualitatively assessed safety culture and Sustainability of the PRisM RM program in the offices by interviews of professional belonging to the offices.
~Quantitatively assessed safety climate in the offices measured by the Medical Office Survey on Patient Safety Culture (MOSPS) Questionnaire (fill in by the professionals of the offices)"
15859465|NCT03966482|Behavioral|Group before-after|The group was submitted to four weeks of speech therapy intervention with Semiocluded vocal tract exercise. The 12 participants were evaluated before and after the intervention with a multidimensional evaluation comprised of analysis of images generated by specialized videonasoendoscopy software, analysis of speech emissions by perceptual-auditory evaluation and acoustic analysis, and vocal self-assessment.
15859466|NCT03966469|Other|Preoperative support person present|Participants who bring a support person to their preoperative appointment.
15859467|NCT03966469|Other|Patient Present Only|Patient presents to their preoperative appointment without a support person.
15859468|NCT03966456|Drug|Chemotherapy|compare the effecy and safety of 4 PD-1 agents single and combined with chemotherapy in chinese people.
15859469|NCT03966430|Procedure|damage control surgery|"Emergency surgery stage, (a) the hybrid operating room restores mesenteric vascular patency. (b) excision of the necrotic intestine (c) retention of suspicious intestinal ducts, double stoma (d) establishment of catheter thrombolysis pathway (e) apply TAC to maintain open abdominal.
~ICU phase, including (a) fluid resuscitation; (b) anti-infective and organ function support therapy; (c) continued local anticoagulation, thrombolysis (d) arrange planned re-laparotomy (e) early EN.
~Definitive surgical procedures, including (a) Deterministic fascia closure or further removal of the necrotic intestine. (b) Intestinal stoma care and enteral nutrition support treatment. (c) An enterostomy was performed about 6 months after the first operation."
15859470|NCT03966430|Procedure|non-damage control surgery|"The patients are diagnosed with AMI and treated for mesenteric thrombosis and ischemic bowel.
~The patient retains the endoluminal catheter after the DSA was diagnosed as AMI.
~After diagnosis, the operation is performed in the general operating room, and the intestinal fistula double or the anastomosis is performed according to the judgment of the surgeon.
~After the operation, re-laparotomy is performed on demand."
15859471|NCT03966417|Other|Exercise training|Continuous exercise training 2 times per week for a period of 12 weeks.
15859472|NCT03966404|Diagnostic Test|EyeBOX device|The EyeBOX medical device tracks a patient's eye movement and calculates a BOX Score ranging from 0-20. The BOX score is interpreted as a binary classification for eye movement abnormalities, where anything equal to or greater than 10 is a positive result for the initial evaluation of concussion and everything below 10 is negative.
15859473|NCT03966391|Other|Multi-faceted knowledge translation intervention|The intervention consists of education of relevant stakeholders of best practices and integration of best practices into the vaccination delivery program
15859474|NCT03966378|Other|Grape seeds extract|Grape seeds extract powder
15859475|NCT03966378|Other|Casein-phosphopeptide/amorphous-calcium phosphate|CPP-ACP paste
15859476|NCT03966365|Drug|PRO-122|"PRO-122. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution free of preservatives. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
~Route of administration: topical ophthalmic."
15859477|NCT03966365|Drug|Krytantek Ofteno®|"- 1. Krytantek Ofteno®. Timolol 0.5% / brimonidine 0.2% / dorzolamide 2% ophthalmic solution. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
~- Route of administration: topical ophthalmic."
15859478|NCT03966352|Other|Questionnaire|Enrolled subjects will complete a questionnaire to ascertain information on treatment considerations, obstacles, motivations, and outcomes encountered on their pathway to fatherhood.
15859479|NCT03966339|Drug|Growth hormone|GH has been considered as a cogonadotropin, which plays an important role in the synthesis of ovarian steroid hormone and follicular development as a paracrine hormone.GH can regulate the growth hormone receptor and strengthen the function of mitochondria to improve the quality of the female oocyte.
15859480|NCT03966326|Drug|sevoflurane and fentanil|Patients will receive standard general anesthesia
15859481|NCT03966326|Drug|sevoflurane and fentanil plus PECS II block|Pacients will receive standard general anesthesia with sevoflurane and fentanil associated to PECS II block
15859482|NCT03966313|Device|ventricular assist device implantation|"Blood sampling in patients under surgery for ventricular assist device implantation at five time points:
~After anesthetic induction
~Before starting the device
~2h, 6h and 48h after starting the device"
15859483|NCT03966300|Other|Multi-faceted knowledge translation intervention|The intervention consists of education of relevant stakeholders of best practices and integration of best practices into the vaccination delivery program
15859484|NCT03966261|Other|blood sample|we perform blood sample in healthy subject before and after a meal to measure incretins concentration
15859485|NCT03966248|Other|Chinese Tuina therapy|"The doctor presses the affected lower limb from the anterior superior iliac spine to the ankle;
~The doctor gives the pressure on the Biguan(ST31), Futu(ST32), Heding(EX-LE2), Neixiyan(EX-LE4), Waixiyan(Dubi, ST35), Zusanli(ST36) and Sanyinjiao(SP6) of the affected lower limb;
~Massage the spleen and stomach meridians of the affected lower extremes;
~Roll the soft tissues around the affected knee;
~Relax the gastrocnalis muscle
~The doctor gives the pressure on the Xuehai(SP10), Liangqiu(ST34), Neixifeng(medial patellofemoral ligament), Waixifeng(lateral patellofemoral ligament), Neixiyan(EX-LE4) and Waixiyan(Dubi, ST35) at the same time;
~Push the patella and do the passive movement of the affected knee;
~Strength training of the affected knee.
~This group receives 8 treatments over a 3 week period with a one week follow-up on site and a 3 month follow-up by mail, phone or email."
15859486|NCT03966248|Other|Physical Manual therapy|"Manual therapy: Stretching the knee joint, stretching the knee joint with valgus or abduction, stretching the knee joint with varus or adduction is suitable for patients with knee flexion and extension difficulty.Patellar manipulation by bending the knee 5-10 degrees downward is suitable for patients with patellar sliding difficulty.The lower end of the muscle length manipulation is suitable for patients with muscle tension and soft tissue tension.Soft tissue loosening is performed in the suprapatellar and peripatellar regions, medial and lateral capsule joints, and popliteal fossa.
~Activity training: Mainly about the knee joint flexion and extension movement training.
~Strength training: Mainly about quadriceps muscle resistance exercises
~This group receives 8 treatments over a 3 week period with a one week follow-up on site and a 3 month follow-up by mail, phone or email."
15859487|NCT03966235|Drug|Melatonin 3 mg|Melatonin was taken daily for 6 months.
15859488|NCT03966235|Drug|Placebo|Placebo tablet was taken daily for 6 months.
15859489|NCT03966222|Device|Endoscopic vein harvest|An endoscope is introduced adjacent to the vein, allowing its dissection under direct vision via a small incision.
15859490|NCT03966222|Other|Open vein harvest|Open vein harvest
15859491|NCT03966209|Drug|JS001(PD-1 inhibitor)|240mg I.V. Q3W
15859492|NCT03966196|Other|Measurements of oxygen saturation and finger pressure during deep inspiration|Measurements during deep inspiration of oxygen saturation with pulse oximeter and finger pressure with pressure cuff
15859493|NCT03966170|Drug|Citicoline|Citicoline as neuroprotector
15859494|NCT03966170|Drug|Placebo oral tablet|placebo drug
15859495|NCT03966157|Device|Nasal Bridle|Feeding tube secured with nasal bridle
15859496|NCT03966144|Device|RoboHear Device|Delivery of haptic sensations followed by testing to assess the ability to interpret stimuli as sounds and words
15859497|NCT03966131|Device|Tongue pressure recordings with the PRESLA prothesis for the Arm1 (patients wearing the complete denture for the first time)|Tongue pressure recordings during speech production, wet and dry swallowing tasks planned in 3 sessions, when the complete denture is worn for the first time, after 3 weeks, then after 3 months in order to characterise the adaptation to this new prosthesis.
15859498|NCT03966131|Device|Tongue pressure recordings with the PRESLA prothesis for the Arm2 (patients used to wear the complete denture)|These measures provide to establish a spatial and temporal mapping of contacts applied by the tongue and lips to the prosthesis during speech production in patients used to their prosthesis. They also provide to establish a spatial and temporal mapping of contacts applied by the tongue and lips to the prosthesis during swallowing) in these patients. The measurement is made at once when the new denture which replaces the old one is placed in the mouth.
15859499|NCT03966118|Drug|Avelumab|Avelumab 1mg/kg Day 1 and Day 15 of a 28-day cycle
15859500|NCT03966118|Drug|Ramucirumab|Ramucirumab 8mg/kg on Day 1 and Day 15 of a 28-day cycle
15859501|NCT03966118|Drug|Paclitaxel|Paclitaxel 80mg/m2 on Day 1, Day 8 and Day 15 of a 28-day cycle
15859502|NCT03966105|Diagnostic Test|HE and Congo red staining|Biopsies will be formalin fixed, processed routinely, and sent to the Department of Pathology for evaluation by hematoxylin and eosin and Congo red staining by pathologists. Biopsy specimens with confirmed amyloid deposits via Congo red staining will be further analyzed using immunohistochemistry for subtyping.
15859503|NCT03966092|Procedure|Quadratus lumborum block|"Bilateral Quatratus lumborum block is performed with ultra sound guidance. The high frequency probe is placed right to the umbilicus, and slips laterally to the side to block. It allows showing the three belts of larges muscles of abdomen (External Oblicum, internal oblicum, and transversal of the abdomen). Laterally, these three are merging to from fascia transversalis. Under fascia transversalis, we can see quadratus lumborum muscle. Punction point in lateral, 1cm in the plan separating quadratus lumborum block and fascia transversalis
~20 ml of ropivacaïne 3.75mg/ml are injected after aspiration test. If in doubt, hydro localisation car be realised."
15859504|NCT03966079|Drug|recombinant tissue plasminogen activator|Patients receive 20 mg of single-dose recombinant tissue plasminogen activator delivered through the catheter
15859505|NCT03966066|Drug|erythromycin|3-5mg/kg.d orally for 6 months
15859507|NCT03966040|Biological|Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0-3-7|36 participants will be given three dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0-3-7
15859508|NCT03966040|Biological|Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-3-7|36 participants will be given four dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-3-7
15859509|NCT03966040|Biological|Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7|36 participants will be given three dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7
15859510|NCT03966040|Biological|Inoculate Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7-14|36 participants will be given four dose of Staphylococcus aureus vaccine(Escherichia Coli) at day 0/0-7-14
15859634|NCT03965208|Drug|Unfractionated heparin|titrated continuous infusion
15859511|NCT03966027|Other|Postoperative protocol (Immediate weight bearing)|After ORIF of the ankle fracture, the patient will be randomized to follow an immediate weight bearing rehabilitation protocol using an offloading hindfoot brace
15859512|NCT03966027|Other|Postoperative Protocol (Delayed Weight Bearing)|After ORIF of the ankle fracture, the patient will be randomized to follow a standard delayed weight-bearing rehabilitation protocol
15859513|NCT03966014|Drug|EM-amoxicillin 3 x 10 days|Patients will receive amoxicillin 500 milligram tid for 10 days
15859514|NCT03966014|Drug|EM-amoxicillin 3 x 14 days|Patients will receive amoxicillin 500 milligram tid for 14 days
15859515|NCT03966014|Drug|EM-amoxicillin 2 x 14 days|Patients will receive amoxicillin 500 milligram bid for 14 days
15859516|NCT03966014|Other|Controls|No intervention.
15859517|NCT03966001|Other|Transvaginal sonography at six months after cesarean section|In the sixth month after cesarean section, Women in both groups will undergo a detailed pelvic examination and transvaginal ultrasonographic evaluation for the cesarean scar defect.
15859518|NCT03966001|Other|Transvaginal sonography at twelve months after cesarean section|In the twelfth month after cesarean section, Women in both groups will undergo a detailed pelvic examination and transvaginal ultrasonographic evaluation for the cesarean scar defect.
15859519|NCT03965988|Drug|DHA|Docosahexaenoic acid
15859520|NCT03965988|Drug|Placebo|Placebo
15859521|NCT03965975|Device|Lab Gold Standard|"First intervention (assigned to the All participants arm)."
15859522|NCT03965975|Device|S-There|"Second intervention (assigned to the All participants arm)."
15859523|NCT03965962|Biological|VRVg-2|"Pharmaceutical form:Powder and solvent for suspension for injection
~Route of administration: Intramuscular"
15859524|NCT03965962|Biological|Purified Vero Rabies Vaccine|"Pharmaceutical form:Powder and solvent for suspension for injection
~Route of administration: Intramuscular"
15859525|NCT03965962|Biological|Human Diploid Cell Vaccine (HDCV)|"Pharmaceutical form:Powder and solvent for suspension for injection
~Route of administration: Intramuscular"
15859526|NCT03965962|Biological|Rabies immune globulin (human)|"Pharmaceutical form:Solution for injection
~Route of administration: Intramuscular"
15859527|NCT03965949|Drug|Hormone Replacement cycle 1|Hormone Replacement cycle (cyclacur) without GnRHa suppression with luteal support (progesterone)
15859528|NCT03965949|Drug|Hormone Replacement cycle 2|Hormone Replacement cycle with GnRHa suppression
15859529|NCT03965936|Procedure|lipofilling|Under local anesthesia using strict aseptic technique, a small incision will be done in the lateral aspect of the thigh or lower abdomen, through which the infiltration cannula will be introduced to inject the local anesthetic solution using the wet technique. This will be followed 15 minutes later by lipo-aspiration of 75 ml fat ) using a blunt tipped cannula under the negative suction pressure of a 60 ml syringe. 50 ml is used for preparation of microfat. then with blunt cannula,subcutaneous injection of the required volume of microfat is placed into temporal region.
15859530|NCT03965936|Procedure|lipofilling enriched with adipose tissue derived stem cells|"Under local anesthesia using strict aseptic technique, a small incision will be done in the lateral aspect of the thigh or lower abdomen, through which the infiltration cannula will be introduced to inject the local anesthetic solution using the wet technique. This will be followed 15 minutes later by lipo-aspiration of 75 ml fat using a blunt tipped cannula under the negative suction pressure of a 60 ml syringe. 50 ml is used for preparation of microfat. 25 ml is used for preparation of autologous adipose tissue derived stem cells (At-ADSCs) using enzymatic digestion and differential centrifugation in the Center of Excellence for Research in Regenerative Medicine and its Application (CERRMA), Alexandria Faculty of Medicine.
~Subcutaneous injection of the required volume of microfat combined with stromal vascular fraction containing adipose tissue derived stem cells, is placed into temporal region."
15859531|NCT03965923|Drug|Dapivirine (DPV) Vaginal Ring (VR)|Vaginal ring containing 25 mg of DPV
15859532|NCT03965923|Drug|Truvada Tablet|Tablet taken orally
15859533|NCT03965910|Other|Demonstration the Importance of Early Rehabilitation in Stroke Patients Based on Diffusion Tensor Imaging Data|"Twenty-eight stroke patients aged 36-72 years admitted to the our Physical Medicine and Rehabilitation Outpatient Clinics were included in this prospective study. After the approval of the ethics committee, written informed consent was obtained from the patients after they were informed about the content and purpose of the study, the schedule of rehabilitation to be administered, and the features of cranial magnetic resonance imaging (MRI) to be performed. Patients with confirmed diagnosis of stroke by computed tomography and/or MRI techniques were randomized into two groups according to the onset of post-stroke rehabilitation. The patients were randomized according to the duration of their admission to our clinic for rehabilitation. Group 1 consisted of patients admitted to our clinic within 1-4 weeks after stroke; Group 2 consisted of patients admitted within 5-8 weeks after stroke.
~Late initiation of rehabilitation in Group 2 patients is not a condition related to our clinic."
15859536|NCT03965884|Other|Physical therapy and rehabilitation|Physical therapy and rehabilitation
15859537|NCT03965871|Drug|Esketamine DPI - low dose|Esketamine DPI is to be administered via dry powder inhaler. Each dose correspond to low Esketamine dose.
15859538|NCT03965871|Drug|Esketamine DPI - medium dose|Esketamine DPI is to be administered via dry powder inhaler. Each dose correspond to medium Esketamine dose.
15859539|NCT03965871|Drug|Esketamine DPI - high dose|Esketamine DPI is to be administered via dry powder inhaler. Each dose correspond to high Esketamine dose.
15859540|NCT03965871|Drug|Placebo DPI|Placebo DPI is to be administered via dry powder inhaler.
15859541|NCT03965858|Drug|Esketamine DPI - low dose|Esketamine DPI is to be administered via dry powder inhaler. Each dose correspond to low Esketamine dose.
15859542|NCT03965858|Drug|Esketamine DPI - medium dose|Esketamine DPI is to be administered via dry powder inhaler. Each dose correspond to medium Esketamine dose.
15859543|NCT03965858|Drug|Esketamine DPI - high dose|Esketamine DPI is to be administered via dry powder inhaler. Each dose correspond to high Esketamine dose.
15859544|NCT03965858|Drug|Placebo DPI|Placebo DPI is to be administered via dry powder inhaler.
15859547|NCT03965832|Device|HFNT during exercise|"6-minute walking test performed initially on HFNT. HFNT will be set with an inspiratory flow rate at 45-55 L/min (maximal tolerated flow), temperature at 37°C or 34°C if perceived as too warm, and fraction on inspired oxygen (FiO2) as at baseline conditions during exercise.
~Participants will then cross-over to repeat the test on baseline conditions."
15859548|NCT03965832|Device|Standard oxygen therapy/RA|6-minute walking test performed on baseline conditions. Participants will then be cross over to repeat the test on HFNT
15859549|NCT03965819|Dietary Supplement|Pain Bloc-R|Herbal Supplement containing Vit D3, Vit B6, Vit B12, White Willow Bark, Angelica Root, Acetyl L-carnitine HCl, Caffeine, L-Theanine, Benfotiamine, and L-Tetrahydropalmatine
15859550|NCT03965819|Other|Active Comparator - Acetaminophen|DIN 02447479 Encapsulated for Blinding Purposes
15859551|NCT03965819|Other|Placebo|No active ingredients
15859552|NCT03965806|Behavioral|SURVEY|SURVEY
15859553|NCT03965793|Device|Automated management of hypotension|Fluid and vasopressor will be administered based on a novel automated clinical decision support system.
15859554|NCT03965780|Other|SPIN-SSLED Program|"The SPIN-SSLED Program is a 3-month-long (13 sessions) group training program designed to be delivered via videoconferencing to provide information and skills to improve leader support group leaders' confidence and self-efficacy to carry out their leadership roles and reduce the burden on them of leading a support group. Each session is about 90 minutes long and covers one of the 13 modules of the program.
~Module topics includes: (1) The Leader's Role; (2) Starting a Support Group; (3) Structuring a Support Group Meeting; (4) Scleroderma 101; (5) Successful Support Group Culture; (6) Managing Support Group Dynamics; (7) Loss and Grief: The support group leader; (8) Loss and Grief in Scleroderma: Supporting group members; (9) Advertising and Recruitment for the Support Group; (10) The Continuity of the Group; (11) Supporting Yourself as a Leader; (12) Remote Support Groups; and (13) Transitions in Support Groups."
15859555|NCT03965767|Drug|Tranexamic Acid|comparison of effect of tranexamic acid on control of bleeding when used locally in the nose or systemic use
15859556|NCT03965754|Behavioral|Social norms|This intervention introduces recipients to descriptive social norms specifying that a majority of their colleagues have signed up for the program, which sets a normative standard against which recipients are expected to compare themselves and to change their behavior accordingly (i.e., when they realize that their behavior is discrepant from that of relevant others). The personal testimonial from a Geisinger medical director serves as a personal exemplar intended to further enhance the effect of the social norms with an implicit indication that the intended behavior is desirable and feasible.
15859557|NCT03965754|Behavioral|Loss framing|This intervention frames the status quo as a state from which recipients, via inaction, are slated to forfeit a sizable and precise monetary amount to which they should otherwise feel entitled (via loss aversion and the endowment effect). People tend to be risk-seeking in the domain of losses; therefore, this intervention is hypothesized to increase enrollment in the hope of achieving zero loss by meeting program goals, as opposed to a sure loss via inaction.
15859558|NCT03965754|Behavioral|Email reminder|This intervention is a standard email reminder that mentions the average premium savings, the speed and ease of starting the process, and the deadline for registering and having health measures on file, plus it provides two button links for registering and finding screenings.
15859559|NCT03965741|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Follow clinical administration
15859560|NCT03965741|Drug|Apixaban(Eliquis)|Follow clinical administration
15859561|NCT03965741|Drug|Pradaxa (Dabigatran etexilate)|Follow clinical administration
15859562|NCT03965728|Drug|BAY1830839|Tablet, oral.
15859563|NCT03965728|Drug|Placebo|Tablet, oral.
15859564|NCT03965728|Drug|Midazolam|For all dose steps. Oral. Two single doses. One dose administered during pre-dose in Period 1 and the second dose administered on the last day of treatment with BAY1830839 or placebo in Period 2
15859565|NCT03965728|Drug|Methotrexate|Only for Dose 3 step. Tablet, oral. Two single doses. One dose administered during pre-dose in Period 1 and the second dose administered on the last day of treatment with BAY1830839 or placebo in Period 2.
15859566|NCT03965715|Device|3D printing AFO, anterior AFO, off-the-shelf AFO|Subjects wear different AFOs and performed gait analysis.
15859567|NCT03965702|Device|Use of a decision support system on the EV1000 monitoring (AFM mode)|The way to administer fluid is based on the same monitoring device but will differ by the way fluid is given ( following a manual GDFT protocol versus following recommendation from an active clinical decision support system for fluid administration called AFM (assisted fluid management) Measurement of all microvascumlar parameters in blinded way.
15859568|NCT03965702|Other|Manual application of the GDFT protocol (standard of care)|Manual application of a GDFT protocol to guide fluid administration. Measurement of all microvascumlar parameters in blinded way.
15859569|NCT03965689|Drug|Carboplatin|Given IV
15859570|NCT03965689|Drug|Paclitaxel|Given IV
15859571|NCT03965689|Drug|Pevonedistat|Given IV
15859572|NCT03965676|Other|Dual-Energy Computed Tomography examination|Dual-Energy Computed Tomography examination at 6 and 12 months +/- 1 month of medical treatment with uricemia < 360μmol/L (baseline DECT is in the domain of usual care).
15859573|NCT03965663|Device|Vibro-tactile Feedback|The device measures the force between the prosthetic food and the ground. With this signals, vibratators are triggered. The vibrators are housed by the prosthetic socket and stimulate the stump.
15859574|NCT03965650|Other|Video coaching exercises|Patients will perform physical exercises following a specifical video coaching program during 6 months.
15869472|NCT03885921|Drug|Simvastatin|oral tablet
15859575|NCT03965650|Other|Routine exercises|"Routine method by advising and encouraging patients to perform exercises according to the WHO recommendations during the first 3 months of the study.
~Thereafter, patients will have access to the video coaching program of physical activities during the following 3 months."
15859576|NCT03965637|Drug|vitamin C|water-soluble vitamin C injection contain of 1000 mg vitamin C that given via intravenous injection
15859577|NCT03965624|Drug|Ninlaro|Oral ixazomib will be given on days 1, 8, 15 of a 28-day cycle, the investigator will start with first test dose levels of ixazomib of 3 mg and process with dose escalation, in case of non-response and no severe adverse events at cycle 1 (see above) or de-escalation in case of response and severe adverse events.
15859578|NCT03965611|Procedure|Oropharyngeal swab|Will be performed by trained paramedical staff using sterile swabs with transport medium ESwab® (Becton, Dickinson and Company, New Jersey, USA). Swabs will be stored at -80°C until DNA extraction.
15859579|NCT03965611|Procedure|Rectal swab|Will be performed by trained paramedical staff using sterile swabs with transport medium ESwab® (Becton, Dickinson and Company, New Jersey, USA). Swabs will be stored at -80°C until DNA extraction.
15859580|NCT03965611|Procedure|Disability rating scale (DRS-F)|Will be assessed at day 90 +/- 7 days.
15859581|NCT03965585|Procedure|in-office hysteroscopy|in-office hysteroscopy with miniaturized instruments
15859582|NCT03965559|Procedure|plasmapheresis|"Plasmapheresis is the removal, treatment, and return or exchange of blood plasma or components thereof from and to the blood circulation. It is thus an extracorporeal therapy (a medical procedure performed outside the body).[Wikipedia]
~DFPP is a selectively removal of the immunoglobulin fraction from the serum and, as a result, to minimize the volume of substitution fluid required. [Tanabe K. Double-filtration plasmapheresis. Transplantation. 2007 Dec 27;84(12 Suppl):S30-2.]"
15859583|NCT03965546|Combination Product|Sorafenib combined with ET140202-T cell|"Sorafenib starting dose of 400mg b.i.d. a.c.
~Autologous T cells transduced with lentivirus encoding an anti-AFP (ET140202) expression construct by intravenous (IV) infusion"
15859584|NCT03965546|Combination Product|TAE combined with ET140202-T cell|"Transarterial embolization(TAE) treatment
~Autologous T cells transduced with lentivirus encoding an anti-AFP (ET140202) expression construct -intravenous (i.v.)"
15859585|NCT03965546|Biological|ET140202-T cell|Autologous T cells transduced with lentivirus encoding an anti-AFP (ET140202) - expression construct -intravenous (i.v.)
15859586|NCT03965533|Drug|GSK2831781|GSK2831781 will be available as Dose-1 and Dose-2 as IV infusion or SC injection. Subjects will receive GSK2831781 Dose-1 IV diluted in 0.9% saline or GSK2831781 SC as multiples of Dose-2 SC.
15859587|NCT03965533|Drug|Placebo|Placebo will be 0.9% saline solution which will be administered in subjects as IV infusion or SC injection.
15859588|NCT03965520|Behavioral|exercise rehabilitation by near-infrared spectrometer|We adjust exercise intensity by the oxygen saturation change show in near-infrared spectrometer
15859589|NCT03965507|Other|Evaluation of the prevalence of sacroiliac joint dysfunction in lumbar disc herniation|
15859590|NCT03965494|Drug|BGB 324 (before surgery)|Given by mouth either BEFORE therapeutic conventional surgery
15859591|NCT03965494|Drug|BGB 324 (after surgery)|Given by mouth either AFTER therapeutic conventional surgery
15859592|NCT03965481|Radiation|Dynamic Enhanced CT|Undergo standard CECT
15859593|NCT03965481|Procedure|Magnetic Resonance Imaging|Undergo PET/MRI scan
15859594|NCT03965481|Procedure|Positron Emission Tomography|Undergo PET/MRI scan
15859595|NCT03965468|Drug|Durvalumab|Durvalumab is a human monoclonal antibody (mAb) of the immunoglobulin G (IgG) 1 kappa subclass that inhibits binding of PD-L1. Durvalumab is expected to stimulate the patient's antitumour immune response by binding to PD L1 and shifting the balance toward an antitumour response.
15859596|NCT03965468|Drug|Carboplatin|Carboplatin belongs to the group of medicines known as alkylating agents. Carboplatin interferes with the growth of cancer cells, which eventually are destroyed.
15859597|NCT03965468|Drug|Paclitaxel|A compound extracted from the Pacific yew tree Taxus brevifolia with antineoplastic activity. Paclitaxel binds to tubulin and inhibits the disassembly of microtubules, thereby resulting in the inhibition of cell division. This agent also induces apoptosis by binding to and blocking the function of the apoptosis inhibitor protein Bcl-2 (B-cell Leukemia 2).
15859598|NCT03965468|Radiation|Stereotactic body radiation therapy (SBRT)|SBRT of all oligo-metastatic lesions
15859599|NCT03965468|Procedure|Surgical resection - definitive local treatment.|Surgical resection of primary tumour for patients with single station, non-bulky tumours.
15859600|NCT03965468|Radiation|Radical radiotherapy - definitive local treatment.|Conventional or moderately hypo-fractionated radiotherapy to the primary tumour for other tumour stages, or in case of medical inoperability.
15859601|NCT03965455|Device|Diode laser|In the laser-assisted frenectomy, a diode laser device (GIGA Cheese II®, China) (λ= 810 nm) with a 400 µm diameter, plain-ended optical ﬁber tip was used for the procedure maintaining contact with oral mucosa at 2,5 W, 70 Hz frequency with a short pulse (140 microseconds) duration.
15859602|NCT03965455|Procedure|Conventional|In the conventional frenectomy, the incisions were applied using a scalpel blade no.15 on the upper and lower surface of the haemostat until the frenum was excised.
15859603|NCT03965442|Drug|Control|Patients who underwent mastectomy under standard general anesthesia
15859604|NCT03965442|Drug|Esmolol|Patients who underwent mastectomy under general anesthesia with esmolol infusion
15859605|NCT03965429|Other|Blood samples (additional tubes from care) longitudinal|Some sampling times will be systematic, while others will only be performed in the presence of specific post-transplant clinical events (eg relapse, GVH ...).
15859606|NCT03965429|Other|Blood samples (additional tubes from care) at inclusion|"In the case of a transplant from an intrafamily donor (genoid or haploid), we will also collect blood samples from the donor. A single blood sample of 28 mL (7 EDTA tubes) will be made.
~In order not to represent an additional sample for the donor, this sample will be taken before the mobilization of the hematopoietic stem cells, during the biological assessment required for the biological donation qualification."
15859607|NCT03965416|Other|White Coat|We included the first and last patients in consultation every day for 10 consecutive days, and every other day the doctor consulted with the use of a white coat or without the use of a white coat.
15859876|NCT03963115|Drug|Epinephrine or normal saline|epinephreine or normal saline coated syringe before drawing allergen for injection.
15859608|NCT03965416|Other|Without White Coat|We included the first and last patients in consultation every day for 10 consecutive days, and every other day the doctor consulted with the use of a white coat or without the use of a white coat.
15859609|NCT03965403|Device|Arm motor function retraining with BURT|Intervention will be focused on patients impairments to assess the feasibility of the BURT device to carry-on long interventions
15859610|NCT03965390|Behavioral|Oral education|"Oral therapeutic education aims to improve dietary practices, daily hygiene and care, in an approach adapted to the characteristics and consequences of Parkinson's disease. An oral prevention package will be given to patients.
~Initially, dentists expose various oral health problems commonly found in Parkinson's disease, in order to give patients the necessary information for the understanding Secondly, dentists dispenseront practical advice tailored to pathology, to maintain good oral health"
15859611|NCT03965377|Behavioral|Home Safety Hero Computer Game|Home Safety Hero computer game presents players with virtual rooms in a home where vilians have planted safety risks. It involves the player taking the role of a body guard for a child. It has three phases: 1. Identifying risks in a set of rooms (e.g., burn, falling, suffocation, poisoning); 2. Identifying risks and then selecting a resolution to reduce the risk or eliminate it entirely; and 3. Identifying risk when faced with distractions typical to home environments (e.g., phone ringing, fire engine siren sounds, a moving child).
15859612|NCT03965364|Device|INCRAFT|Device: Endovascular abdominal aortic aneurysm repair Subjects with infrarenal abdominal aortic aneurysms who meet all inclusion criteria and none of the exclusion criteria will be treated with the INCRAFT Stent Graft System.
15859613|NCT03965351|Drug|Probenecid|This is a cross-over pilot study where participants will receive both the study medication (probenecid), as well as a placebo to see if the study medication improves magnetic resonance parameters of systolic and diastolic dysfunction that occurs in the Fontan population.
15859614|NCT03965351|Other|Placebo|placebo
15859615|NCT03965338|Diagnostic Test|fMRI|Screening
15859616|NCT03965325|Other|Use of a standardized set to collect clinical and patient-centered data, to assess the trend of the Global Health Status overtime in colorectal cancer patients|Patients' data (baseline characteristics, clinical and PROMs outcomes) will be collected according to patient-centered standardized set regarding ICHOM recommendations. Data collection and the follow-up schedule are carried out at : baseline (before any treatment or surgery), 1- and 6-month follow-up and then once a year.
15859617|NCT03965312|Device|Continuous temperature monitor|Temperature will be measured using a novel temperature monitor continuously for up to 72 hours. Accuracy (as compared to a commercially available patient monitor) will be evaluated.
15859618|NCT03965312|Device|Neonatal Incubator|Infants at risk for hypothermia will be placed in a neonatal incubator. Their temperature will be monitored as they are treated. The infant will be treated until the infant is transitioned to skin-to-skin care, discharged, or no longer at risk for hypothermia.
15859619|NCT03965312|Device|Patient monitor|Temperature will be measured using a commercially available patient monitor.
15859620|NCT03965299|Device|VERUM TTNS|"Daily 30-minute TTNS intervention is performed 5 days a week during a treatment period of 6-9 weeks, until 3-month post assessments
~During a preparation phase of several minutes, sensory and motor thresholds are assessed and stimulation intensities are adjusted for the following 30-minute treatment phase"
15859621|NCT03965299|Device|SHAM TTNS|"Daily 30-minute SHAM intervention is performed 5 days a week during a treatment period of 6-9 weeks, until 3-month post assessments
~During a preparation phase of several minutes, sensory and motor thresholds are assessed and stimulation intensities are adjusted for the following 30-minute treatment phase"
15859622|NCT03965286|Drug|DAAs|Daily fixed-dose combination of ledipasvir (90 mg)/sofosbuvir (400 mg) 12 weeks Daily simeprevir (150 mg) plus sofosbuvir (400 mg) 12 weeks Daily daclatasvir (60 mg) plus sofosbuvir (400 mg) 12 weeks Daily fixed-dose combination of paritaprevir (150 mg)/ritonavir (100 mg)/ombitasvir (25 mg) with dasabuvir (600 mg) 12weeks
15859623|NCT03965273|Behavioral|Full TP|The overall Tipping Point intervention package will span 18 months and will involve: i) Weekly facilitated training sessions with girls' groups and boys' groups; ii) Dialogue sessions jointly with girls' groups and fathers' groups, and girls' groups and boys' groups; iii) Community and Social Norms Change Component; iv) Facilitated sessions with mothers' groups and (separate) fathers' groups; v) 2-days intensive facilitated workshop with selected religious leaders and influential people; vi) Village savings and loans associations (VSLAs) formed by the girls' group members to create opportunities for girls to engage in age-appropriate income generating activities and build their potential as entrepreneurs; vii) Trainings of girls, boys and parents with special interest in activism.
15859624|NCT03965273|Behavioral|Light TP|The overall Tipping Point intervention package will span 18 months and will involve: i) Weekly facilitated training sessions with girls' groups and boys' groups; ii) Dialogue sessions jointly with girls' groups and fathers' groups, and girls' groups and boys' groups; iii) Facilitated sessions with mothers' groups and (separate) fathers' groups; iv) 2-days intensive facilitated workshop with selected religious leaders and influential people; v) Village savings and loans associations (VSLAs) formed by the girls' group members to create opportunities for girls to engage in age-appropriate income generating activities and build their potential as entrepreneurs; vi) Trainings of girls, boys and parents with special interest in activism.
15859625|NCT03965260|Biological|Bacterial samples from blood or peritoneal liquids|"For each cirrhotic patient hospitalized for a bacterial infection, a blood sample or a peritoneal liquid sample was collected and analyzed for susceptibility, as it is performed in the standard of care. Our department receives only the bacterial results.
~We will then describe the bacterial ecology of the center cirrhotic population in terms of infection acquisition mode, infection site, infection etiology but also drug-resistance."
15859626|NCT03965247|Drug|Lithium|
15859627|NCT03965247|Other|Placebo - Rayotabs|
15859628|NCT03965234|Drug|Cisplatin|Given via infusion
15859629|NCT03965234|Procedure|Isolated Chemotherapeutic Lung Perfusion|Undergo pulmonary suffusion
15859630|NCT03965234|Procedure|Metastasectomy|Undergo metastasectomy
15859631|NCT03965221|Behavioral|LYNX|Access to the LYNX mobile app which includes the Sex Pro score tool, sex diary, badges, PrEP information and video testimonials, HIV/STI testing reminders and geo-location features, and asynchronous chat feature.
15859632|NCT03965221|Behavioral|MyChoices|Access to the MyChoices mobile app which includes the HIV test plan with reminders, STI information, PrEP resources, links to testing and PrEP sites, and geo-location features.
15859635|NCT03965195|Biological|Recombinant Influenza Vaccine|Nursing home residents and staff 18 years and older are allocated to receive quadrivalent recombinant influenza vaccine.
15859636|NCT03965195|Biological|Standard Dose Quadrivalent Influenza Vaccine|Nursing home residents and staff 18 years and older are allocated to receive standard dose quadrivalent influenza vaccine
15859637|NCT03965182|Drug|PEG|2 sachets of PEG will be used as the bowel prep regimen.
15859638|NCT03965182|Drug|PEG plus SPMC|one sachet of PEG and one sachet will be administered as the bowel prep regimen
15859639|NCT03965182|Drug|SPMC|2 sachets will be administered as the bowel prep regimen.
15859640|NCT03965169|Procedure|Prone spinal surgery|spinal surgery in prone position under general anesthesia
15859641|NCT03965156|Procedure|1) Ultrasound guided Erector spinae block|In the lateral position, after skin sterilization, erector spinae plane block will be performed at the level of T9. Counting down from the spine of seventh cervical vertebrae, the spine of the nine thoracic vertebrae (T9). A linear low frequency ultrasound transducer (US) (3-5 MHz) will placed sagittal 3cm lateral to midline to visualize the muscles of the back, transverse process and simmering pleura in between transverse processes. A 22-gauge short bevel needle will be inserted in cranial-caudal direction towards transverse process (TP) in plane to the US transducer until needle touched the TP crossing all the muscles. The location of the needle tip will be confirmed by visible normal saline fluid separating erector spinae muscle off the bony shadow of the transverse process on ultrasound imaging. Then 20 ml of bupivacaine 0.375% plus plus 5ug/ml adrenaline (1:200000) will be injected. The procedure will be repeated following the same steps on the other side of the back.
15859642|NCT03965156|Procedure|Ultrasound guided transversus abdominis plane block|in supine position and after skin sterilization. The linear high frequency transducer (6-13 MHz) will be placed in the transverse plane to the the lateral abdominal wall in the midaxillary line, between the lower costal margin and iliac crest. The three abdominal wall muscles (external oblique, internal oblique, and transversus abdominis) are visualized. The needle inserted in plane and advanced anterior to posterior under continual visualization until the tip between the internal oblique and the transversus abdominis muscle. After negative aspiration, a 20 ml of bupivacaine 0.375% plus 5ug/ml adrenaline (1:200000) will be injected. The success of the injection will be confirmed by separation of the internal oblique and transversus abdominis with a distinct pocket of local anesthetic in between. The procedure will be repeated following the same steps on the other side.
15859643|NCT03965143|Device|3D talar augmentation|Patients with an avascular necrosis of the body if the talar bone will undergo a 3D custom talar augmentation with or without concomitant ankle arthroplasty
15859644|NCT03965130|Drug|Glucagon|PINTA study with or without glucagon
15859645|NCT03965117|Drug|Norepinephrine|norepinephrine will be started at 0,1 mcg/kg/min and titrated according to its haemodynamic effect. After baseline MAP (which is > 60 mmHg), norepinephrine is targeted according baseline MAP. At T2, MAP is between 10 - 20 % above baseline (T1), at T3 MAP is between 20 - 30 % above baseline (T1).
15859646|NCT03965104|Behavioral|Hypertension Canada Professional Certification Program: HC-PCP|The HC-PCP is a certification program which aims to provide training to generalist primary care providers in the screening, prevention, and management of hypertension.The competencies assessed in the program have been validated for their importance through a national survey of hypertension experts and primary care providers.
15859647|NCT03965091|Drug|Fremanezumab - Dose A|Administered subcutaneously (sc) for 4 monthly doses at Visits 3, 4, 5, and 6.
15859648|NCT03965091|Drug|Fremanezumab - Dose B|Administered subcutaneously (sc) for 4 monthly doses at Visits 3, 4, 5, and 6.
15859649|NCT03965091|Drug|Placebo|Administered subcutaneously (sc) for 4 monthly doses at Visits 3, 4, 5, and 6.
15859650|NCT03965078|Drug|topical (eye drop) anti-inflammatories|Initial treatment with topical anti-inflammatory eye drops at the discretion of the reviewing clinician
15859651|NCT03965065|Device|Sutureless aortic bioprosthesis|Patients will receive a sutureless aortic bioprosthesis
15859652|NCT03965065|Device|Conventional stented sutured aortic prosthesis|Patients will receive a stented sutured aortic prosthesis
15859653|NCT03965052|Drug|PRO 179|"Generic name: Travoprost
~Distinctive denomination: Bristrio® (PRO-179)
~Active principles: Travoprost 0.004%.
~Pharmaceutical form: Ophthalmic solution
~Presentation: multi-dose dropper bottle, 2.5 milliliters.
~Prepared by: Sophia Laboratories, S.A. of C.V.
~Description of the solution: transparent solution, free of visible particles.
~Description of container: White bottle with 5 milliliters capacity, made of low density polyethylene."
15859654|NCT03965052|Drug|Travatan 0.004 % Ophthalmic Solution|"Generic name: Travoprost
~Distinctive denomination: Travatan®
~Active ingredients: Travoprost 0.004%
~Pharmaceutical form: Ophthalmic solution.
~Presentation: multi-dose dropper bottle, 2.5 milliliters.
~Prepared by: Alcon Laboratories Inc.
~Description of the solution: transparent solution, free of visible particles.
~Consult information to prescribe."
15859655|NCT03965039|Device|Dipotassium oxalate toothpaste|Experimental dipotassium oxalate (3%) toothpaste
15859656|NCT03965039|Drug|Stannous fluoride toothpaste|Marketed stannous fluoride (0.454%) toothpaste
15859657|NCT03965039|Drug|Potassium nitrate toothpaste|Marketed potassium nitrate (5%) toothpaste
15859658|NCT03965039|Drug|Sodium monofluorophosphate toothpaste|Marketed sodium monofluorophosphate (0.76%) toothpaste
15859659|NCT03965013|Drug|NNC0268-0965|2 to 3 dose levels will be tested in Part 1. 3 to 5 dose levels will be tested in Part 2
15859660|NCT03965013|Drug|Placebo|A single dose of placebo given in Part 1
15859661|NCT03965013|Drug|insulin glargine|Insulin glargine given at a fixed dose level of 0.5 U/kg
15859662|NCT03965000|Other|Mixed-meal-tolerance-test|To assess the dynamics of the glucagon-incretin axis we need to perform the MMTT. Thereby the patients need to consume a body weight adjusted, standardized meal and we draw blood at fixed time points over 4 hours.
15859701|NCT03964636|Diagnostic Test|OCT-A (optical coherence tomography)|Included patients will have an OCT-A and will be questioned about their medical and ophthalmologic history, and their oestro-progestative contraceptive intake.
15859702|NCT03964623|Diagnostic Test|OCT-A (Optical Coherence Tomography)|Included patients will have an OCT-A and will be questioned about their nicotine intake, their background and taking an oral conception
15859703|NCT03964610|Diagnostic Test|color fundus photography (CFP) and OCT-A|Included patients will have an ophthalmologic assessment (OCT-A and CPF) after stabilization and at 3 months follow-up.
15872219|NCT03864419|Drug|Prednisone|Given PO
15859663|NCT03964974|Behavioral|Cognitive Behavioral Therapy for Insomnia in Cannabis Users|Each CBTi-CB therapy session will review the previous week of sleep/wake diaries and summarize key sleep parameters with participants. The treatment will address cannabis use by increasing use of appropriate coping strategies and improving self-efficacy to manage insomnia and next-day consequences. The content includes: (1) Sleep Scheduling Strategies to consolidate sleep using behavioral strategies that increase the drive for sleep and stabilize the circadian timing system; (2) Sleep Hygiene to discuss behaviors, substances, and environmental conditions that can help or hinder sleep; (3) Cognitive Therapy aims to identify and alter dysfunctional beliefs about sleep and functioning that contribute to insomnia; (4) Counter-Arousal Strategies address ruminative thoughts and increased body tension interfering with ability to fall or return to sleep; (5) Relapse Prevention for Insomnia reviews treatment gains and the behavioral and cognitive strategies that were most helpful.
15859664|NCT03964974|Behavioral|Sleep Education|The SE condition will be matched to the CBTi-CB condition in terms of level of attention and the non-specific aspects of receiving social support from a study therapist, without providing individualized recommendations. The current content includes: (1) Insomnia History of the participant, including triggers that initiated the problem, duration, severity, and frequency, premorbid sleep characteristics, and previous sleep treatments; (2) Sleep Education about why we sleep, sleep stages, sleep regulation at night, and sleep changes across lifespan; (3) Substance Use and Sleep and the effects of cannabis and other licit and illicit substances on sleep; (4) Environmental Factors that contribute to a sleep-conducive environment; (5) Lifestyle Factors like the effects of diet, exercise, and napping on sleep; (6) Sleep Maintenance Strategies to review treatment gains from the participant's perspective and emphasize the principles covered to maintain sleep improvements.
15859665|NCT03964961|Other|Functional massage|It's a massage combined with a stretching of the muscles.
15859666|NCT03964961|Other|Conventional massage|It's a regular massage made with the therapist's hands.
15859667|NCT03964948|Diagnostic Test|Kidney MRI|An MRI examination will be completed per research MRI protocol.
15859668|NCT03964935|Drug|Lycopene|"Prepared by solving lycopene powder in a solvent (ethanol: propylene glycol: water in the ratio of 50:30:20). The solution was then gelled by adding 8% hydroxypropyl cellulose (HPC). The concentration of the prepared gel equals to 2%.
~After SRP, the gel delivered into periodontal pocket using insulin syringes, the therapeutic dose is about 2mg/0.1 ml."
15859669|NCT03964935|Drug|Minocycline HCl 1mg Oral Powder|Minocycline HCl Microspheres, 1mg minocycline powder per cartridge. A locally applied antibiotic that is placed directly into the infected periodontal pocket following SCR.
15859670|NCT03964935|Other|Distilled water|Used to irrigate periodontal pockets after SRP
15859671|NCT03964922|Biological|blood sample|20 ml at inclusion, and 20ml at 1, 3, 6 and 12 months after allo HSCT
15859672|NCT03964922|Biological|bone marrow sample|3 ml at inclusion, and 3 ml at 1, 3, 6 and 12 months after allo HSCT
15859673|NCT03964909|Procedure|Functional Magnetic Resonance Imaging|Undergo fMRI
15859674|NCT03964909|Procedure|Magnetic Resonance Imaging|Undergo CVR MRI
15859675|NCT03964909|Procedure|Resting State Functional Connectivity Magnetic Resonance Imaging|Undergo rs-fMRI
15859676|NCT03964896|Other|Survey|Complete survey
15859677|NCT03964896|Other|Survey Administration|Ancillary studies
15859678|NCT03964896|Behavioral|Telephone-Based Intervention|Receive telephone calls
15859679|NCT03964870|Diagnostic Test|Diagnostic of polymorphisms in malignant hyperthermia|Identify and catalogue the variants or polymorphisms in the RYR1 and CACNA1S genes in the Spanish population.
15859680|NCT03964857|Other|Refined olive oil (ROO)|Consumption of chicken dishes made with ROO for a period of 8 weeks
15859681|NCT03964857|Other|Blended Oil 1 (BO1)|Consumption of chicken dishes made with BO1 for a period of 8 weeks
15859682|NCT03964857|Other|Blended Oil 2 (BO2)|Consumption of chicken dishes made with BO2 for a period of 8 weeks
15859683|NCT03964844|Other|No intervention|No intervention
15859684|NCT03964805|Other|20% oxygen|culture excusively at 20% O2 (Day 0 to Day 6)
15859685|NCT03964805|Other|5% oxygen|culture excusively at 5% O2 (Day 0 to Day 6)
15859686|NCT03964805|Other|20 % and 5 % oxygen|culture at 5% from Day 0 to Day 3, then at 20% from Day 3 to Day 6)
15859687|NCT03964792|Genetic|DREPAGLOBE drug product|Each patient will receive a single IV infusion of DREPAGLOBE drug product
15859688|NCT03964779|Diagnostic Test|Hormonal assay|Measurement of Thyroid stimulating hormone
15859689|NCT03964779|Diagnostic Test|Antibody assay|antithyroglobulin and antithyroid peroxidase
15859690|NCT03964766|Device|Rotary instrumentation|using pedo rotary files in cleaning and shaping the root canals of infected primary molars
15859691|NCT03964766|Device|Hand instrumentation|using conventional hand files in cleaning and shaping the root canals of infected primary molars
15859692|NCT03964753|Drug|Nab-paclitaxel and Cisplatin|Nab-paclitaxel,125mg/m(2), d1,d8, Cisplatin,75mg/m(2), d1, 3 week, 2 cycles.
15859693|NCT03964753|Procedure|surgery|surgery
15859694|NCT03964740|Other|Mobile App intervention|The intervention is based on the interventional group subjects use of a mobile device with an ad-hoc designed application (called ASMATIC). This app permit them (in a daily basis) to record asthma control variables (peak-flow and presence of core symptoms), have daily reminders on their medication for asthma control and decision support for patient disease self-management; and contains advice on healthy lifestyle habits, including personalized diet recommendations based on clinical criteria and associated recipes. The device also permits the study subject to communicate with the hospital and for the study team to review potential issues of interest on the patient's asthma control parameters which might need an intervention such us additional in-person consultations
15859696|NCT03964701|Other|no intervention|no interventional study
15859697|NCT03964688|Drug|Vitamin C|vitamin C intravenous during hospitalization, after oral, total 6 weeks.
15859698|NCT03964688|Drug|Placebos|placebo intravenous during hospitalization, after oral, total 6 weeks
15859699|NCT03964675|Device|SenseGuard|A single invitational visit with a respiratory rate measurement duration of 30 minutes.
15859700|NCT03964662|Device|WeReha|Rehabilitation of stroke patients with the device WeReha
15859762|NCT03964090|Drug|TEDDI-R|Temozolomide, etoposide, doxil, dexamthasone, ibrutinib and rituximab (TEDDI-R) given every 21 days for cycles 1-4
15859704|NCT03964597|Diagnostic Test|Measurement of lens opacification|Measurement of OSI and ALD at inclusion and during post-IVT follow-up visits to M3, M6, and M12, +/- M18, +/- M24 and +/- M30.
15859705|NCT03964584|Other|assessment of neurological and psychiatric disorders by self-administered questionnaires|Patients will be included on the day dolutegravir or bictegravir is prescribed. Neurological and psychiatric disorders will be assessed using self-administered questionnaires, at inclusion, one month, three months and six months.
15859706|NCT03964571|Diagnostic Test|WOUNDCHEK|fluid swab of wound and measurement of wound onto film
15859707|NCT03964558|Drug|[14C]-acebilustat solution|Acebilustat is a novel synthetic small molecule leukotriene A4 hydrolase (LTA4H) inhibitor.
15859708|NCT03964545|Behavioral|neurofeedback|Patients are instructed to reduce amygdala activation by means of down-regulating the EFP. An auditory feedback interface is used with the instruction to down-regulate volume of a jingle, reflecting intensity of EFP.
15859709|NCT03964532|Drug|Talazoparib|Talazoparib (formerly MDV3800 and BMN673) is an oral small molecule, selective inhibitor of PARP-1 and PARP-2.
15859710|NCT03964532|Drug|Avelumab|Avelumab (formerly MSB0010718C) is a human immunoglobulin G1 (IgG1) anti-PD-L1 monoclonal antibody131 that utilizes both adaptive and innate immune mechanisms.
15859711|NCT03964519|Other|Acute changes|In a crossover design, participants will be randomized to perform on Day 1, 3 sets of repetitions (depending on each treatment group) at 70% or 1RM in the full squat exercise. 48-h later, same will be performed but in the contrary crossover arm.
15859712|NCT03964519|Other|Chronic changes|In a randomized control trial, participants will train during 6 weeks the full squat exercise, 2 days in the week (minimum between-days rest of 48h). Intensity will vary from 70% to 85 of 1RM, and training volume from 3 to 6 sets.
15859713|NCT03964519|Other|Familiarization|Prior to any intervention, all participants will perform a familiarization of the exercise session, together with a progressive resistance test to estimate the 1 RM
15859714|NCT03964506|Drug|Hyperbaric oxygen|Reduced intensity conditioning Fludarabine and Melphalan with Hyperbaric Oxygen and Allogeneic Hematopoietic Stem Cell Transplant
15859715|NCT03964493|Drug|TNP-2092|TNP-2092 100mg/vial
15859716|NCT03964493|Drug|Vancomycin|Vancomycin 1g/vial
15859717|NCT03964467|Device|transcranial direct current stimulation|see arm/group descriptions
15859718|NCT03964454|Behavioral|WIC support + home-based individual support + Breastfeeding Incentives (SC+BFI)|Participants randomized into SC+BFI will receive the same services as the Standard Care Control (SC) group (standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving) plus financial incentives (Breastfeeding Incentives, BFI) contingent on observed breastfeeding.
15859719|NCT03964454|Behavioral|WIC support + home-based individual support (SC)|Participants randomized into SC will receive standard breastfeeding services from Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) plus monthly home visits that facilitate navigation to as-needed resources and referrals to services that support breastfeeding and problem solving.
15859720|NCT03964441|Biological|Invasive fetal sampling, blood sampling of mother and father|to perform an exome sequencing analysis in trio
15859721|NCT03964441|Biological|blood sampling from the mother to recover the circulating cell free fetal DNA|to perform a sequencing analysis of the genome of circulating free fetal DNA
15859722|NCT03964441|Other|Parent interviews (optional organizational study)|Interview with a sociologist or psychologist to explore perceptions of ES and the impact of the results, expectations regarding certain types of results not currently available, the emotional situation, and position regarding the continuation of the pregnancy At 4 different times: at inclusion, at the time of the CGA-array results, at the time of the ES results and at a distance from the ES results
15859723|NCT03964441|Other|parent questionnaire (optional organizational study)|To evaluate the experience, perceptions, the impact of the analyses on the decision, satisfaction and concerns regarding the ES and its results, opinions on certain types of results not currently available, as well as anxiety and possible psychological distress At 4 different points in time: at inclusion, at the delivery of the CGA-array results, at the delivery of the ES results and at a distance from the delivery of the ES results
15859724|NCT03964441|Other|professional interviews (optional organizational study)|interview to understand how the decision is formed
15859725|NCT03964441|Other|Focus group for professionals (optional organizational study)|interview to specify whether variants of unknown significance) VUS will potentially be returned to the clinicians, or even to the patient via the clinician.
15859729|NCT03964402|Drug|intervention treatment|intervention treatment (any)
15859730|NCT03964389|Other|Therapeutic Neuroscience Education (TNE)|A talk on Neuroscience Education (EN). This intervention aims to provide information in a clear and simple way to the participants so that through it the patients may be able to modify their attitude towards pain, inviting them to take a more active and less contemplative role. Neuroscience has shown that it is possible to have persistent pain without damage to the tissues or with damage that justifies the perceived disproportion of pain.
15859731|NCT03964376|Other|Nasal High Flow|Delivery of oxygen via OptiflowTM system (AirvoTM, Fisher & Paykel Inc.) with airflow of 20 to 50 Litre/minute
15859732|NCT03964376|Other|Usual Care|Delivery of oxygen at 2-4 Litre/minute via nasal cannula or 6 Litre/minute via face mask
15859733|NCT03964363|Behavioral|Unsupervised home-based physical prehabilitation|Subsequent to screening and initial testing for frailty syndrome, participants receive an information booklet containing a selection of exercises, which allows independent prehabilitation at home.
15859763|NCT03964090|Drug|Ibrutinib|For Arm 1:Ibrutinib given on days -14 to day -1 prior to cycle 1;then given every 21 days for cycles 1-4 For Arm 2: Ibrutinib given on days -14 to day -1 prior to cycle 1; then on days 1-10 for cycles 1-4
15859764|NCT03964090|Drug|Cytarabine|Cytarabine on days 1 and day 5 of cycles 2-5 (all arms), as applicable
15872220|NCT03864419|Drug|Etoposide|Given IV
15859734|NCT03964350|Drug|Ethanol|"The 0.8 g/kg body weight dose of gelatin alcohol will be divided into an average of 10 servings of 0.08 g/kg each. The 0.8 g/kg dose is equivalent to 4 standard drinks, where a standard drink is defined as one 12 oz beer, one 5 oz glass of wine, or one 1.5 oz shot of 80 proof alcohol.
~The 0.4 g/kg body weight dose of gelatin alcohol will be divided into an average of 5 servings of 0.08 g/kg each. The 0.4 g/kg dose is equivalent to 2 standard drinks, where a standard drink is defined as one 12 oz beer, one 5 oz glass of wine, or one 1.5 oz shot of 80 proof alcohol."
15859735|NCT03964350|Other|Placebo|The placebo comparator will be individual servings of back cheery sugar-free jello.
15859736|NCT03964337|Drug|Cabozantinib|Cabozantinib 40 mg by mouth daily for 4 weeks.
15859737|NCT03964337|Procedure|Radical Prostatectomy|Radical prostatectomy as part of routine medical care.
15859738|NCT03964324|Diagnostic Test|Fractioned Exhaled Nitrogen Oxide measurements|Measurements of Fractioned Exhaled Nitrogen Oxide obtained by blowing into a mouthpiece. The NIOX VERO machine will be used for these measures.
15859739|NCT03964311|Other|Emergency Room Evaluation Tool (ER2)|Emergency Room Evaluation Tool represents a screening method that will be used at the Emergency by nurses. This tool evaluates the health conditions of all the patients who are 75 years and over.
15859740|NCT03964285|Other|rumination induction|The induction method is based on specific instructions given to participants on how to focus on different elements of their experience. For example, they will be led, in the rumination condition, to reflect on the causes, meanings and consequences of the amount of tension they feel in their muscles.
15859741|NCT03964285|Other|distraction induction|The induction method is based on specific instructions given to participants on how to focus on different elements of their experience. In the distraction condition they will, for example, imagine a ship crossing the Atlantic.
15859742|NCT03964272|Device|Exablate Bilateral Subthalamotomy|Exablate bilateral treatment for Parkinson's Disease Motor Features
15859743|NCT03964259|Drug|Intravenous fluids|Administration of post HDMTX intravenous fluids (IVF)
15859744|NCT03964246|Behavioral|Compassion Meditation (CM) intervention|"Thee CBCT-Vet includes 10 90-minute sessions that will be led by certified CBCT therapist with significant experience in administering CBCT-Vet. Sessions 1 - 4 assist participants in basic mindfulness breathing practices; sessions 4 - 8 focus on personal analysis of factors underlying difficulties with compassion for self or others; the final two sessions (9 and 10) review content and assist with relapse prevention. Session by session topics are: (1) Introduction and learning breathing meditation, (2) Focused attention, (3) Creating space, (4) Mindful awareness, (5) Re-engaging with heroic spirit, (6) Seeing ourselves in others, (7) Appreciation and gratitude, (8) Empathy and engaged compassion, (9) Putting it all together, and (10) Putting it all together 2."
15859745|NCT03964246|Other|Heathy Aging Psychoeducation|The investigators will develop and test a 10-week psychoeducational group focused on topics in healthy aging to examine its feasibility as a control condition for a subsequent VA Merit-supported randomized controlled trial. This will include multiple resources for community education regarding healthy aging, including a library of videotaped community-focused talks, such as increasing happiness, mental resilience and health, nutrition, and physical activity. These resources will be incorporated into 90-minute sessions wherein the key information from talks is shown to participants, with a follow-up discussion and review period led by the group facilitator. In the context of the present feasibility study, the investigators anticipate modifying and refining the content and format of the group in response to participant feedback.
15859746|NCT03964233|Drug|BI 907828|Film-coated tablets
15859747|NCT03964233|Drug|BI 754091|Solution for infusion
15859748|NCT03964233|Drug|BI 754111|Solution for infusion
15859749|NCT03964220|Drug|Tiotropium Respimat®|Tiotropium Respimat® 1.25 mcg (on top of baseline Inhaled Corticosteroid/Long-acting beta-agonist )
15859750|NCT03964220|Drug|Inhaled Corticosteroid/Long-acting beta-agonist|baseline low dose to medium/high dose, baseline medium dose ICS/LABA to high dose ICS/LABA, additional prescription/refill of high-dose-ICS/LABA following the first prescription of baseline high dose ICS/LABA
15859753|NCT03964181|Other|Change in school start times|Elementary start times changed from 9:00 a.m. to 8:00 a.m.; middle school start times changed from 8:00 a.m. to 8:50 a.m.; high school start times changed from 7:10 a.m. to 8:20 a.m.
15859754|NCT03964168|Drug|Biologic Agent|Patients who discontinued a bioloic agent
15859755|NCT03964155|Biological|Sample|After an exposure duration of at least 12 hours, a sample of directly-aspirated, undiluted pulmonary edema fluid will be collected concurrently with AnaConDa-S® filter collection.
15859756|NCT03964142|Other|Cardiac rehabilitation|"Integrated cardiac rehabilitation program that includes supervised exercise training*.
~* Due to the COVID-19 pandemic, supervised physical exercise training had to be conducted telematically (through live guided training sessions conducted online, with the same design, frequency, and dosage of exercise)."
15859757|NCT03964129|Procedure|Avance Nerve Graft with Autologous BMAC|The Avance Nerve Graft will be inserted in the area of nerve injury. Between 40 to 60 ml of Bone Marrow Aspirate from the anterior or posterior iliac crest of the pelvis will be harvested. Using SmartPrep centrifuge and 60 ml BMAC kit, 7 to 10 ml of final BMAC will be obtained. Of the 7 to 10 ml of final BMAC that is yielded, half (3.5 to 5 ml) of the final concentrate, will be injected on top of the Avance Nerve Graft following coaptation. The second half (3.5 to 5 ml) of the final concentrate will be inserted into a sterile tube containing culture media and shipped overnight to Cleveland Clinic Lerner Research Institute for cell processing and colony assay to confirm that the BMAC indeed contains autologous bone marrow stem cells.
15859758|NCT03964116|Other|Questionnaires set all 3 months|"This longitudinal study based upon repeated and multicentric measurement will recruit AYA with cancer in care Units dedicated to them or not. Measures will be quantitative, and repeated every 3 months by questionnaires, as well as qualitative (social network questionnaire, psychological research interview) for teenagers declaring a negative event or a death event during treatments.
~Those patients presenting a high depression score will be contacted by a research psychologist for semi-directed interview."
15859759|NCT03964103|Dietary Supplement|gQ-lab daily|probiotics
15859760|NCT03964103|Dietary Supplement|Placebo|powdered skim milk, lactose
15859761|NCT03964090|Drug|TEDD-R|Temozolomide, etoposide, doxil, dexamthasone, and rituximab (TEDD-R) given every 21 days for cycles 1-4
15859765|NCT03964090|Drug|Isavuconazole|Isavuconazole to begin at least 3 days prior to ibrutinib and continue throughout chemotherapy unless ibrutinib discontinued permanently
15859766|NCT03964090|Drug|Methotrexate|Methotrexate on days 1 and day 5 of cycles 2-5 (all arms), as applicable
15859767|NCT03964077|Diagnostic Test|Neurogenic Bladder Symptom Score Questionnaire|Neurogenic Bladder Symptom Score Questionnaire is a self-reported 24 item questionnaire.
15859768|NCT03964064|Radiation|Stereotactic Radiotherapy|"GTV: Combining localization and fusion images to delineate the tumors seen PTV = GTV + 0-10mm Target volume radiation dose: The range of BED value of radiotherapy was 80-100 when the distance between the tumor and gastrointestinal tract was more than 5 mm (alpha/beta=10) and 60-80 when the distance between the tumor and gastrointestinal tract was less than 5 mm (alpha/beta=10).
~Normal Tissue Limit: Reference to TG101 Report"
15859769|NCT03964064|Radiation|3D-printing Template-assisted CT-guided I125 Seed Implantation|CT-guided radioactive 125I particle therapy with 3D printing template for pancreatic cancer Preoperative planning Design and fabrication of 3D-PNCT Particle implantation Postoperative dose assessment: CT scan was performed after operation, and the image was transmitted to BTPS for dose verification . The dosimetric parameters included tumor volume, D90, mPD, V100, V150 and V200.
15859770|NCT03964051|Drug|Omalizumab Injection|Omalizumab 300 mg for subcutaneous injection
15859771|NCT03964038|Drug|gilteritinib|oral
15859772|NCT03964038|Drug|gilteritinib mini tablet|oral
15859773|NCT03964025|Device|Wearing Cardioskin™ for 14 days|The current standard of care for diagnosing AF is through the use of a 24 hour Holter device. In this study, in addition to wearing the 3-lead Holter recorder for 24 hours, the subject will be wearing the Cardioskin™ for a period of 24 hours as well, after which the subject will continue wearing the Cardioskin™ alone for an additional period of 13 days.
15859774|NCT03964012|Biological|NmCV-5|Polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysaccharide antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to C reactive material (CRM) protein. The diluent is Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
15859775|NCT03964012|Biological|Menactra|Menactra is available as ready to use solution containing polysaccharide antigens A,C,Y&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine
15859776|NCT03963999|Diagnostic Test|Ultrasound Elastography|Ultrasound shear wave elastography
15859777|NCT03963999|Drug|Contrast Enhanced Ultrasound (CEUS)|Contrast-enhanced ultrasound (CEUS) uses an intravenous injection of microbubble contrast agent.
15859778|NCT03963986|Device|STIMUL group|The STIMUL Group participants in the Adaptive Physical Activity Focus (APA) program receive access to an online digital Platform, as well as a starter kit consisting of a connected pedometer measuring several physical activity indicators including the number of steps, number of so-called active minutes, sleep time, and distance travelled; a tape measure and a starter guide. They then conduct a remote assessment and motivational interview by videoconference or telephone, followed by 15-20 minute support interviews (month 1, month 3, month 6). Between these interviews, during months 1, 2, and 3, participants exchange weekly written messages with an educator on their platform. A planner of their physical activity objectives is provided.
15859779|NCT03963973|Drug|RDN-929 oral capsule|low, medium and high dose
15859780|NCT03963973|Drug|Placebo oral capsule|matching placebo dose
15859781|NCT03963960|Device|Hemodialysis with low dialysate flow|Hemodialysis with low dialysate flow
15859782|NCT03963960|Device|Conventional triweekly high-flow hemodialysis|Conventional triweekly high-flow hemodialysis
15859783|NCT03963947|Biological|Beltavac® Polymerized with house dust mites|Adminstration of Beltavac® Polymerized with house dust mites according to the routine clinical practice
15859784|NCT03963934|Other|Program on a nurse-led telephone 6-month-follow-up for uncontrolled hypertensive women: a patient-tailored intervention|Implementation of personalized support: The accompaniment includes 7 telephone interviews for 6 months (understanding the antihypertensive treatment, identifying the brakes and the levers when taking medication, organizing the treatment taking, making the home blood pressure)
15859785|NCT03963921|Drug|HepaStem|Heterologous human adult liver-derived progenitor cells
15859786|NCT03963908|Behavioral|AtEase|AtEase is a tailored pain self-management mobile app that tailors participant's feedback based on readiness to engage in pain self-management and preference for self-management strategies.
15859787|NCT03963908|Behavioral|Chronic Pain Education|CBT-based Education on Pain Self-Management for Veterans
15859788|NCT03963895|Drug|AB002|AB002 (E-WE thrombin) specified dose on specified day administered as a single intravenous infusion
15859789|NCT03963895|Drug|placebo|placebo specified dose on specified day administered as a single intravenous injection
15859790|NCT03963882|Drug|Two cycles of neoadjuvant chemotherapy|Two cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/m2 and cisplatin 70 mg/m2, on day 1, once for three weeks).
15859791|NCT03963882|Diagnostic Test|First imaging evaluation|First imaging evaluation consists of pelvic magnetic resonance imaging (MRI) and positron emission tomography (PET)
15859792|NCT03963882|Diagnostic Test|Second imaging evaluation|Second imaging evaluation consists of pelvic magnetic resonance imaging
15859793|NCT03963882|Drug|The third cycles of neoadjuvant chemotherapy|The third cycles of neoadjuvant chemotherapy (paclitaxel 175 mg/m2 and cisplatin 70 mg/m2, on day 1, once for three weeks).
15859794|NCT03963882|Procedure|RH|Radical hysterectomy
15859795|NCT03963882|Radiation|Radiochemotherapy|Concurrent radiochemotherapy
15859796|NCT03963882|Diagnostic Test|Pathologic evaluation|Pathologic evaluation for RH patients
15859797|NCT03963869|Other|Malaria Camps|The Govt. of India Malaria Control Programme (MCP) of Odisha provides ITNs and IRS, and trains community health workers (ASHAs) on the diagnosis and treatment of malaria, providing them with antimalarial drugs so that malaria treatment is available even in remote villages. Faced with a persistent burden of malaria in forest villages, the MCP recently introduced malaria camps (MCs) combining focused screening and treatment in villages with intensified vector control. The program includes one round of testing and treatment for the whole village population before the monsoon season, followed by one round of screening and treating of fever cases only during the monsoon season.
15859798|NCT03963856|Other|parbolic flight|weightlessness during parabolic flight
15859823|NCT03963674|Other|Diacutaneous fibrolysis|Diacutaneous fibrolysis over the gastrocnemious muscles
15859799|NCT03963843|Behavioral|Guided ICBT|An 8-week internet- delivered cognitive behavioural therapy (ICBT) will be delivered to participants who have sustained a spinal cord injury. In addition to the online program, a health educator with experience delivering ICBT will provide support by email once a week. The health educator will spend approximately 15 minutes per week/per client.
15859800|NCT03963843|Other|SCI rehabilitation mental health education|Participants will receive information provided to SCI patients in usual care at specialized SCI rehabilitation units (the Spinal Cord Injury Rehabilitation Evidence (SCIRE) Community handouts available at: https://scireproject.com/community/handouts/). The lessons will include information on spinal cord injury rehabilitation: 1)spinal cord injury basics, 2)mental health after SCI, 3)pain after SCI, 4)understanding rehabilitation 5)summary of lessons through an online platform over 8 weeks. A health educator will check in with participants once a week to answer any content related questions. The health educator will spend approximately 15 minutes per week/per client.
15859801|NCT03963830|Behavioral|MOVE UP|Each of the 12-group-sessions will focus on incremental behavioral strategies for maintaining recommended healthy eating, activity, and weight loss behaviors. Participants will monitor body weight and weight loss behaviors. Body weight will be measured at each in-person session and participants will also be encouraged to measure their body weight on their own. Beginning in Session 3, participants are given a home physical activity goal of 10 minutes/day, 50 minutes/week. The goal is raised by 5 minutes/day, 25 minutes/week every other session, the final goal being 30 minutes/day, 150 minutes/week. All subjects will be recommended to engage in an energy restricted dietary intervention that evidence demonstrates has effectively reduced body weight by 5-7% within the initial 4 months of the intervention. This will include reducing energy intake to 1200 to 1800 kcal/d based on initial body weight (<200 pounds = 1200 kcal/d; 200 to 250 pounds = 1500 kcal/d; >250 pounds = 1800 kcal/d).
15859802|NCT03963817|Diagnostic Test|adaptive optics AO-OCT/AF instrument|Using the new adaptive optics AO-OCT/AF instrument, the study team will image 10 normal subjects in order to optimize image acquisition and interpretation.
15859803|NCT03963817|Diagnostic Test|adaptive optics AO-OCT/AF instrument|Using the new adaptive optics AO-OCT/AF instrument, the study team will image 40 adult subjects with age-related macular degeneration (AMD) who have non-neovascular AMD and soft drusen or subretinal drusenoid deposits in the macula.
15859804|NCT03963804|Device|BrainScope Ahead 300iP|The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT5), Electrophysiological Function; Neurocognitive Performance Assessment and Ocular Motor Assessment. BrainScope Ahead 300iP will be used to perform EEG and Cognitive assessments.
15859805|NCT03963791|Other|Eggshell powder gel|Eggshell powder gel produced from chicken eggs.
15859806|NCT03963791|Other|CPP-ACP crème|A water-based, sugar-free topical cream containing Recaladent (CCP-ACP) which is derived from the milk protein.
15859807|NCT03963778|Behavioral|Improving nutritional care|The interventions will be co-designed with the action research team
15859808|NCT03963765|Procedure|Group I (Standard DL-PDT)|Daylight photodynamic therapy with photosensitizer (MAL - Metvix, Galderma ®)
15859809|NCT03963765|Procedure|Group II (DL-PDT with microneedles)|Daylight photodynamic therapy with photosensitizer (MAL - Metvix, Galderma ®) and Microneedles - motorized pen with a tip of 17 grouped needles with 0,5mm (Dermapen Beauty®- Korea) as a techniques of transepidermal drug delivery (TED)
15859810|NCT03963765|Procedure|Group III (DL-PDT with CO2 laser)|Daylight photodynamic therapy with photosensitizer (MAL - Metvix, Galderma ®) and Ablative Fractional Laser (AFXL), CO2 laser, roller-type ferrule, composed of one row with seven fractionating pins (7x1), 60 W, 15 mJ/pixel, 125μm/pixel, 2 mm spacing between ablation zones, density <1% (Pixel Alma Lasers ®) was applied, single-pass
15859811|NCT03963765|Procedure|Group IV (DL-PDT with microdermabrasion)|Daylight photodynamic therapy with photosensitizer (MAL - Metvix, Galderma ®) and Microdermabrasion - aluminum oxide crystal (Pan Eletronic®) as a techniques of transepidermal drug delivery (TED)
15859812|NCT03963752|Drug|Ziyinxiehuo Granules Herbs|1 pack of Ziyinxiehuo granules Herbs is administered after dissolved, 2 times per day after a meal.
15859813|NCT03963752|Drug|Megestrol Acetate Tablet|the dose is 6-8mg/d, three times per day after meals.
15859814|NCT03963752|Drug|Leuprorelin Acetate 3.75mg Injection|Usage： 80μg/kg by subcutaneous injection, every 4 weeks
15859815|NCT03963739|Other|Interview|Undergo interview
15859816|NCT03963739|Other|Questionnaire Administration|Ancillary studies
15859817|NCT03963726|Radiation|stereotactic radiotherapy|The liver metastases were treated with Cyberknife stereotactic radiotherapy.Using multimodal image fusion to outline the target area.According to the volume, location, organ function and other factors, the dosage of radiotherapy was determined. The range of BED value of radiotherapy was 90-120 when the distance between the tumor and gastrointestinal tract was more than 5 mm (alpha/beta=10) and 70-90 when the distance between the tumor and gastrointestinal tract was less than 5 mm (alpha/beta=10).
15859818|NCT03963726|Other|microwave alabation|The colorectal cancer patients with liver metastases will receive microwave ablation.3D printing template was used to assist microwave ablation.For those whose lesions are directly smaller than 5.0cm, the ablation time is about 10 min and 15 min, and the ablation time is more than 15min in patients larger than 5.0cm.
15859819|NCT03963713|Radiation|Stereotactic radiotherapy|Using multimodal image fusion to outline the target area.PTV = GTV + 0-10mm Target volume radiation dose: The range of BED value of radiotherapy was 60-72 when the distance between the tumor and gastrointestinal tract or spinal cord was more than 5 mm (alpha/beta=10) and 51.3-59.5 when the distance between the tumor and gastrointestinal tract or spinal cord was less than 5 mm (alpha/beta=10).
15859820|NCT03963713|Radiation|Conventionally-fractionated image- guided Intensity modulated radiotherapy|Using multimodal image fusion to outline the target area.The dose of the target volume radiotherapy dose is 30 Gy/10f or 40Gy/20f.Previous treatment and follow-up data will be analyzed to evaluate the clinical efficacy comparison of stereotactic radiotherapy and conventionally-fractionated image-guided intensity-modulated radiotherapy for spinal metastatic tumors, local control rate and side effects, and to clarify the effectiveness and safety of different doses of radiotherapy.
15859821|NCT03963687|Other|Standard Nursing Education Intervention|Genetics Education Program for Nurses (GEPN) which is available free online for more than 20 years
15859822|NCT03963687|Other|New Nursing Education Intervention|Web-based Genomics/ Genetics Nursing Education is a free online course that will be designed by the research team.
15859824|NCT03963661|Behavioral|c-SIGHT (computorized spatial innatention grasping home-based therapy)|C-SIGHT will be self-administered at people's homes. c-SIGHT is a computerized therapy administered via people's television. The therapy involves performing repeated rod lifts with the less impaired arm in response to auditory and visual instructions presented on the television screen connected to a laptop. A small motion-tracking camera monitors rod lifts during therapy sessions. People will be asked to self-administer c-SIGHT for 1 hour a day (30min after breakfast and 30min after lunch) for 7 consecutive days. The first day of therapy will be performed with a therapist there for training purposes.
15859825|NCT03963648|Diagnostic Test|Fractioned Exhaled Nitrogen Oxide measurements|Measurements of Fractioned Exhaled Nitrogen Oxide obtained by blowing into a mouthpiece. The NIOX VERO machine will be used for these measures.
15859826|NCT03963635|Diagnostic Test|MicroB-plex Lyme Immunoassay|Subject's blood and clinical data are collected to develop a diagnostic immunoassay
15859827|NCT03963622|Other|Respiratory Mechanics|"Different maneuvers based on respiratory mechanics will be assessed at the bedside and will be used to individualize ventilator parameters. Recruitability will be assessed with a one breath decremental PEEP maneuver, and search for airway closure with a low-flow pressure volume or pressure-time curve. If the patient has airway closure, the minimal PEEP will be set at the airway opening pressure to avoid closure. If the patient is considered recruitable, the goal is to set PEEP at or above 15cmH20 to maximize alveolar recruitment, until the plateau pressure reaches the safety limit. Volume control ventilation at 6ml·kg-1 will be used.
~Once spontaneous breathing has started, the occlusion pressure (P0.1) will be maintained within targets."
15859828|NCT03963622|Other|Standard Ventilation Strategy|Patients randomized to the control arm will receive standard care. The PEEP is adjusted for oxygenation based on a PEEP-FiO2 table, either the low PEEP-FiO2 or the high PEEP-FiO2 table. Volume targeted ventilation with initial VT 6 mL·kg-1 and Plateau pressure at 30 cmH2O or below, targeting PaO2 60-80 or SpO2 90-95%, adjusted as per the protocol. Pressure-support ventilation is at physician's discretion, but recommended when FiO2 <60%, and is titrated VT 6-8 mL·kg-1.
15859829|NCT03963609|Radiation|multisclice CT|assessment of the remodeling index by multisclice CT in patients with chronic stable angina
15859830|NCT03963596|Procedure|Intravitreal injection|Intravitreal injection to the regimen pro re nata.
15859831|NCT03963583|Behavioral|HEROIC|"The HEROIC intervention will include individualized, nurse-led sessions focused on;
~a whole-person assessment including preventive health behaviors, personal goals, and purpose in life
~discussion of caregiving in the context of the caregiver's identified 'purpose' which supports meaning-making and provides rationale for goal-setting
~co-development of a plan to address caregiver goals to improve preventive health behaviors and/or reduce caregiver burden
~'walking meetings' to model the importance of exercise while discussing incremental action plans to help caregivers achieve goals."
15859832|NCT03963570|Behavioral|Safe Step - digital exercise program|"After receiving the Safe Step application the participants view an instruction movie on how to use the application to create and progress their own individual exercise program. The exercises, presented in video format, are organized into 10 predetermined groups with a main focus to improve balance (3 groups), increase lower-limb strength (4 groups), and improve gait/step (3 groups). The participants choose an exercise suitable for their needs from each group to compose a program of ten exercises.
~They can use the app to plan their exercises, set reminders, register their exercise, and view statistics of their progress. A virtual physiotherapist deliver motivational messages and feed-back. At the end of every month, of the 1 year intervention period, the participants will receive an email asking them to report any falls during the past month by answering a short digital survey. This message will provide a new video each month with general falls prevention information besides exercise."
15859833|NCT03963570|Behavioral|Control group|Participants randomized to the control condition will only be given information. They will receive exactly the same email messages as the intervention group with falls prevention information and a request to report any falls. At the end of the 12 month intervention we will, in addition to the other questions, ask if they have started to do any exercises during the intervention period. After the 12 month follow-up assessment the control group will be offered the Safe Step application.
15859834|NCT03963544|Drug|oral tyrosine-kinase inhibitors (TKI) of KIT and PDGFR as per recommendations|oral tyrosine-kinase inhibitors (TKI) of KIT and PDGFR
15859835|NCT03963531|Other|chemotherapy, surgery, radiotherapy, interventional radiology.|
15859836|NCT03963518|Drug|Immune checkpoint inhibitor|Immune checkpoint inhibitor
15859837|NCT03963492|Other|Walking|Participants will undergo training in either the CONT or INT walking interventions 2x/week for 6 weeks for a total plan of 12 training sessions.
15859838|NCT03963479|Combination Product|Magnesium and Vitamin B6|Magnesium and Vitamin B6 will be given to the enrolled patients for 3 months
15859839|NCT03963466|Drug|tranexamic acid|Oral tranexamic acid group(menstrual period>2days) 250mg bid（exclude menstrual period ）
15859840|NCT03963466|Radiation|1064-nm Q-Switched fractional laser|Device: 1064-nm Q-Switched fractional laser is used for melisma with the MASI ≥24 left side of cheek is selected to be treated with 1064-nm Q-Switched fractional laser therapy (8ms, 1.5±0.5J/cm2) once 4 weeks for a total of 5 times
15859841|NCT03963466|Radiation|1064-nm Q-Switched laser|Device: 1064-nm Q-Switched laser is used for melisma with the MASI ≥24 right side of cheek is selected to be treated with 1064-nm Q-Switched laser therapy (8ms, 1.5±0.5J/cm2) once 4 weeks for a total of 5 times
15859842|NCT03963453|Other|Physical Exercise|Physical exercise are prescribed to be performed three times per week for a year
15859843|NCT03963440|Other|Exercise Adherence Rating Scale (EARS)|"Inclusion and first questionnaires period (10 questionnaires), after geting consent, during normal patient consultation schedule for functional restoration program of the lumbar spine (1 to 3 weeks hospital in day care).
~Second questionnaire period at 48h (Only EARS questionnaire) Third questionnaires period (10 questionnaires) at the end of the restoration program hospital care.
~Fourth and last questionnaires period (10 questionnaires) at 3 months during a normal patient follow-up consultation No additional appointments."
15859844|NCT03963427|Procedure|Breast reconstruction|Irradiated women are randomized to reconstruction with a latissimus Dorsi flap and an implant or a deep inferior epigastria perforator flap. Non-irradiated women are randomized to reconstruction with a thoracodorsal flap with an implant or with an expander and later a permanent implant in two stages.
15859875|NCT03963128|Dietary Supplement|Placebo|Placebo administred every two months
15872221|NCT03864419|Biological|Rituximab|Given IV
15859845|NCT03963414|Combination Product|Durvalumab + Tremelimumab in combination with carboplatin and etoposide|1500mg of durvalumab plus 75mg of tremelimumab in combination with carboplatin and etoposide will be given every 3 weeks for Cycles 3 and 4. 1500mg of durvalumab plus 75mg of tremelimumab will be given every 3 weeks for Cycles 5 and 6.
15859846|NCT03963414|Combination Product|Durvalumab in combination with carboplatin and etoposide|1500mg of durvalumab in combination with carboplatin and etoposide will be given every 3 weeks for Cycles 3 and 4.
15859847|NCT03963401|Drug|PF-06700841|Starting after the Week 16 visit, subjects receiving PF-06700841 10 mg once daily will start to randomly receive either the 60 mg QD dose or 30 mg QD dose until Week 52, as predetermined at randomization. All subjects will receive blinded dosing throughout the 52 weeks study treatment period in order to maintain the study blind.
15859848|NCT03963401|Other|Placebo|Starting after the Week 16 visit, subjects receiving placebo will start to randomly receive either the 60 mg QD dose or 30 mg QD dose until Week 52, as predetermined at randomization. All subjects will receive blinded dosing throughout the 52 weeks study treatment period in order to maintain the study blind.
15859849|NCT03963388|Other|Speech therapy|Online speech therapy, delivered by specialized speech therapists. Speech therapy will be complemented by a real-time visual feedback app (the Voice Trainer app).
15859850|NCT03963375|Drug|Cladribine|All participants will receive cladribine 10 mg tablets at a cumulative dosage of 3.5 mg/kg divided into 2 treatment courses as per the United States Prescribing Information (USPI) (1.75 mg/kg per treatment course; Year 1 and Year 2 treatment). Patients will be randomized 1:2:2:1 to receive a total of 2 Lumbar Punctures at specific time points during the treatment cycle.
15859851|NCT03963362|Drug|GLA5PR tablet 75 mg|GLARS-NF3 tablet
15859852|NCT03963362|Drug|GLA5PR tablet 150 mg|GLARS-NF3 tablet
15859853|NCT03963336|Drug|LMWH|Subcutaneous LMWH 1mg/kg/day for 2 weeks
15859854|NCT03963336|Drug|acetazolamide|Carbonic anhydrase inhibitor 1-2g/day for 6 months
15859855|NCT03963323|Dietary Supplement|Glucosamine Sulfate/Chondroitin Sulfate Tablet|Given PO
15859856|NCT03963323|Other|Placebo|Given PO
15859857|NCT03963284|Procedure|cardiac surgery|pediatric cardiac surgery with cardiopulmonary bypass
15859858|NCT03963284|Device|NephroCheck test|Urine of the subjects undergoing cardiac surgery with CPB will be tested by NephroCheck test
15859859|NCT03963271|Diagnostic Test|ECG-Imaging|A body surface potential mapping and a cardiac + low dose CT-scan.
15859860|NCT03963258|Device|whole-body vibration training|The subjects were exposed to alternating vertical sinusoidal vibration using a Galileo tilting table system.The frequency of WBV ranged from 5 to 20 Hz, and the amplitude ranged from 1 to 6 mm.The subjects were kneeled on the ground, both shoulders flexed at 90 degrees, elbows slightly flexed, their trunk bent in this position and contacted on the platform board with their palms equidistant from the midpoint of the board
15859861|NCT03963258|Other|conventional upper limb training|compensatory techniques for activities of daily living, UE strength, therapist-guided techniques for facilitating normal UE movement patterns,and range of motion and traditional positioning
15859862|NCT03963245|Behavioral|Meaningful Activities and Recovery|"MA&R is a new rehabilitation program for people with psychiatric disabilities. MA&R aims to enable participation in everyday activities that are meaningful to the individual.
~MA&R is based on occupational science, and the underlying premise that there is a connection between mental health, recovery and meaningful everyday activities. The goal of MA&R is that participants through the course become better at connecting daily activities with values, interests, plans and goals. When this connection is strengthened, it supports the experience of meaningfulness in everyday life.
~MA&R is led by two mentors where one mentor is an occupational therapist (or similar) and the other has lived experiences of mental vulnerability and recovery."
15859863|NCT03963245|Behavioral|Standard Care and Treatment|"For community mental health centres: medicine, psychoeducation, relational support, peer-support, psychotherapy, social counselling, care manager
~For psychiatric rehabilitation services in Copenhagen, Odense and Svendborg: drop in centres, relational support, skills training, peer-support"
15859864|NCT03963232|Drug|Galcanezumab|Administered SC
15859865|NCT03963232|Drug|Placebo|Administered SC
15859866|NCT03963219|Device|ABC4D|The complete integrated system consists of a smartphone that holds the advanced decision support algorithm. The system requires regular updates of cases derived from continuous glucose monitoring (CGM) data. Each new case includes information about the problem (e.g. capillary blood glucose, meal information and physical exercise), solution (recommended insulin dose) and outcome (post-prandial blood glucose).
15859867|NCT03963219|Device|Standard Bolus Calculator|Standard bolus calculator
15859868|NCT03963206|Drug|Cabozantinib group|The patient starts at 60 mg / day at a distance from meals In the event of intolerance to this dose of 60 mg; specific adapted measures will be taken according to the recommendations of the good practices of use of Cabozantinib within the framework of its MA. If the symptomatic treatments are not enough, each investigator can adapt the dose of Cabozantinib reducing it to 40 or even 20 mg / day Cabozantinib will be continued for as long as radiological and / or clinical benefit is observed for the patient (no progression of the disease) or until the occurrence of unacceptable toxicity.
15859869|NCT03963193|Drug|Etoposide|Etoposide 100mg/m^2 ivggt on days 1, 2, 3, Cisplatin 25mg/m^2 ivggt on days 1, 2, 3, repeated every 21 days.
15859870|NCT03963193|Drug|Irinotecan|Irinotecan 65 mg/m^2 ivggt on days 1, 8, Cisplatin 30 mg/m^2 ivggt on days 1, 8, repeated every 21 days.
15859871|NCT03963180|Other|coffee|All patients were asked to drink the entire 150-mL amounts within 20 minutes under the supervision of a nurse or doctor. Patients were free to drink any amount of water but no more coffee, black tea, or other forms of caffeine, such as soda. Coffee and hot water were prepared with a conventional coffee machine (Nescafe Alegria; 100 g caffeine; Nestlé. Gatwick, United Kingdom).
15859872|NCT03963167|Drug|BDP/FF/G fixed combination|Fixed combination of Inhaled Corticosteroid (ICS) / Long-acting β2-agonist (LABA) / long-acting muscarinic antagonist (LAMA) that contains Beclometasone dipropionate (BDP), Formoterol fumarate (FF) and Glycopyrronium (G).
15859873|NCT03963154|Biological|Human Embryonic Stem Cell Derived Retinal Pigment Epithelium (RPE)|Implantation into one eye of hESC-derived RPE (Human Embryonic Stem Cell Derived Retinal Pigment Epithelium (RPE))
15859874|NCT03963128|Dietary Supplement|Supplementation Vitamin D3|Supplementation of vitamin D3 at a dose of 50.000 IU administered every two months (equivalent of 800 IU per day)
15859877|NCT03963102|Drug|Ameluz|Leaving on the gel for 4 hours rather than the standard 3 hours.
15859878|NCT03963089|Procedure|Tidal volume_6mL/kg|Set tidal volume to 6mL/kg for 1 minute
15859879|NCT03963089|Procedure|Tidal volume_10mL/kg|Set tidal volume to 10mL/kg for 1 minute
15859880|NCT03963089|Procedure|Tidal volume_14mL/kg|Set tidal volume to 10mL/kg for 1 minute
15859881|NCT03963089|Procedure|Fluid loading|Administer 10mL/kg of crystalloid for 5 minutes
15859882|NCT03963076|Other|nasal hypertonic spray: combination of hypertonic sea water and organic rosemary floral water with essential oils (ravintsara, geranium, eucalyptus radiata, niaouli)|One spray of nasal hypertonic spray morning and evening every day during 30 days
15859883|NCT03963063|Procedure|Goal-directed fluid therapy|"Patients in the group will follow our mini-fluid challenge test goal-directed therapy protocol, maintaining:
~individualized optimised stroke volume by mini-fluid challenge first
~keep mean arterial pressure ≧65 mmHg
~keep systolic blood pressure ≦140 mmHg
~keep cardiac index ≧ 2.5 L/min/cm2"
15859884|NCT03963063|Procedure|Non goal-directed fluid therapy|"Patients in the group will receive standard perioperative care at the discretion of care-giving anesthesiologist, maintaining:
~keep mean arterial pressure ≧65 mmHg
~keep systolic blood pressure ≦140 mmHg"
15859885|NCT03963050|Other|Exercise Training|The ET program will consist of endurance exercises at 70% of maximal Heart Rate and resistance exercises at 85% of 1 repetition maximum.
15859886|NCT03963050|Other|Exercise Training + Cognitive Training|"ET: The intervention program will consist of endurance exercises at 70% of maximal Heart Rate and resistance exercises at 85% of 1 repetition maximum.
~CT: The intervention program will be configured as a cognitive rehabilitation and mainly memory rehabilitation: the participants will be trained in practicing restorative and compensatory mnemonic techniques, such as visual imagery, face-name association, calendar, notes and prompts."
15859887|NCT03963050|Other|Control|NO changes in lifestyle
15859888|NCT03963037|Other|Blood draw|Draw venous blood for baseline blood parameters and plasma samples for lipoprotein fractionation.
15859889|NCT03963024|Drug|"Conditioning treatment Treosulfan-TMI"|Treosulfan i.v.: 14 g/m²/d (day -6 to -4) Fludarabine i.v.: 30 mg/m²/d (day -6 to -2) Antithymocyte globulin (ATG)-Fresenius i.v.: 5/0 mg/kg (day -4 to -2) Mabthera i.v.: 200/0* mg/m2 (day -1) TMI: (10 Gy) 2 Gy bis in die (BID) (day -2 to -1) or TMI: (12 Gy) 2 Gy BID (day -3 to -1) or TMI: (14 Gy) 2 Gy BID (day -3 to -1)
15859890|NCT03963024|Procedure|SCT|Stem Cell Transplant
15859891|NCT03963024|Drug|GvHD prophylaxis|Rapamycin p.o.: 4 mg/d, (target 8-15 ng/ml) (starting day -7) Mycofenolate mofetile: 10 mg/kg tid, (Maximum dose 720 mg/tid) (starting from day 0)
15859892|NCT03963011|Diagnostic Test|Bowel Ultrasound|Ultrasound imaging of the bowel
15859893|NCT03962998|Drug|Lactulose/Rhamnose solution|Lactulose/Rhamnose solution administered orally followed by measurement of excreted lactulose and rhamnose in urine
15859894|NCT03962998|Drug|MB-102|MB-102 solution administered orally followed by measurement of excreted MB-102 in urine
15859895|NCT03962985|Other|Guided tour at the Montreal Museum of Fine Arts|"The duration of the participation -3 months
~The duration of the guided tour-45 minutes, each week
~All participants will be asked to fill out some specific online questionnaires during their participations in the study"
15859896|NCT03962972|Other|Frailty evaluation|It will be used a questionnaire that is called:The Centre of Excellence Self-Administered questionnaire (CESAM). The score of this questionnaire and its stratification of frailty in four levels with incident adverse health events in older community dwellers will be compare with the three validated frailty indexes which are the Cardiovascular Health Study frailty index, Study of Osteoporotic Fracture index and Rockwood frailty index.
15859897|NCT03962959|Device|TMS|TMS is a non-invasive brain stimulation technique. The primary aim of the study will be to verify the deliverability of the TMS effect on the hippocampus and determine which stimulation protocol is more beneficial to each participant.
15859898|NCT03962946|Other|Questionnaires to assess Patient reported Outcomes|Adolfsson-Score questionnaire quantifies the patient's utility of the hand. Suhm Score questionnaire quantifies the independency of a patient in his daily life.
15859899|NCT03962946|Other|wrist function test|wrist function assessed by the range of motion (ROM) for both the affected and the unaffected side.
15859900|NCT03962933|Diagnostic Test|Urine test|Urine test will be taken every three months after first resection of bladder tumor
15859901|NCT03962920|Drug|Tigecycline 50 MG|Local instillation of drug directly to the tumour tissue
15859902|NCT03962920|Other|Placebo|Local instillation of sterile water directly to the tumour tissue
15859903|NCT03962907|Drug|Chlorhexidine, Lifo-Scrub sol 4%®, 500ml, B. Braun|5 - day decolonization procedure prior elective surgery. In carriers with Chlorhexidine daily showers and Mupirocin twice a day nasal ointment. In non-carriers Chlorhexidine showers will be used.
15859904|NCT03962907|Drug|BACTROBAN® Nasal ong|Mupirocin, BACTROBAN® Nasal ong, 3g, GSK
15859905|NCT03962894|Drug|Prednisolone|During a sequenced rollout protocol change for Lee County EMS, certain ambulance stations who are randomized to early adoption of an upcoming protocol change will administer prednisolone to children with asthma attacks in the prehospital environment prior to ED arrival. Ambulance randomized to later protocol adoption will continue usual care, until the end of the study when all ambulance stations adopt the new protocol with early administration of prednisolone
15859906|NCT03962881|Biological|20 µg recombinant hepatitis B vaccine at months 0, 1, and 6|three-dose, 20 µg per dose
15859907|NCT03962881|Biological|20 µg recombinant hepatitis B vaccine at months 0, 1, 2,and 6|four-dose, 20 µg per dose
15859908|NCT03962881|Biological|60 µg recombinant hepatitis B vaccine at months 0, 1, 2,and 6|four-dose, 60 µg per dose
15859909|NCT03962868|Procedure|Experimental procedure : ESD|ESD is a new endoscopic resection procedure that allows en-bloc resection for large superficial colorectal neoplasms. It used dedicated devices and consists in a deep submucosal dissection under the lesion after surelevation thanks to submucosal fluid injection and mucosal incision all around the lesion. The en bloc resection allows a perfect pathological analysis and a very low risk of recurrence (<1.5%)
15859947|NCT03962608|Device|Placebo|Study patients will be dosed daily with a quantity of placebo equivalent to 8g of product Yaq-001 for a period of 48 weeks. The product will be provided as beads packed in individual sachets intended each for one oral administration. For each patient, the study duration will be up to 54 weeks, including the screening (up to 45 days), treatment (48 weeks) and 7-day follow up period.
15859910|NCT03962868|Procedure|Comparison procedure: WF-piece meal EMR|WF-piece meal EMR is an older endoscopic resection technique. After surelevation of the lesion thanks to fluid submucosal injection, the precancerous lesion is resected in several pieces using a polypectomy snare. At the end of the procedure when macroscopically visible adenoma has been totally resected a snare tip coagulation of the margin of the scar is performed to destroy potential non visible residual adenoma. This procedure is quicker, safer than ESD but result in more recurrent disease (from 10 to 30% for lesions larger than 25 mm).
15859911|NCT03962855|Drug|Ifetroban Sodium|Ifetroban sodium 250 mg capsule once daily for 4 weeks
15859912|NCT03962855|Other|Placebo|Placebo arm to match Ifetroban Sodium once daily for 4 weeks.
15859913|NCT03962842|Other|Pilates method|The intervention program consisted in the realization of exercises of the Pilates Method. The duration of the program was 32 weeks, with a frequency of two weekly sessions and a duration per intervention of 10 minutes. During this time the experimental group developed the intervention program with the Pilates Method.
15859914|NCT03962829|Drug|mCPP|Healthy participants administrate one capsule of mCPP (30mg)
15859915|NCT03962829|Drug|Placebo oral tablet|Healthy participants administrate one capsule of placebo (containing lactose)
15859916|NCT03962816|Biological|20 µg recombinant hepatitis B vaccine at months 0, 1, and 6|three-dose, 20 µg per dose
15859917|NCT03962816|Biological|20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6|four-dose, 20 µg per dose
15859918|NCT03962816|Biological|60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6|four-dose, 60 µg per dose
15859919|NCT03962803|Biological|20 µg recombinant hepatitis B vaccine at months 0, 1, and 6|three-dose, 20 µg per dose
15859920|NCT03962803|Biological|20 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6|four-dose, 20 µg per dose
15859921|NCT03962803|Biological|60 µg recombinant hepatitis B vaccine at months 0, 1, 2, and 6|four-dose, 60 µg per dose
15859922|NCT03962790|Device|1-DAY ACUVUE® MOIST|etafilcon A contact lenses made with a new manufacturing technology
15859923|NCT03962790|Device|1-DAY ACUVUE® MOIST|etafilcon A contact lenses made with the current manufacturing technology
15859924|NCT03962777|Other|chlorhexidine|patients used chx moutrinses for four days
15859925|NCT03962777|Other|oil pulling|patients used oil pulling for four days
15859926|NCT03962764|Behavioral|Responsible Fatherhood Program|24 hours of fatherhood curriculum, 6 hours of financial literacy, workforce development, and case management.
15859927|NCT03962751|Behavioral|Simultaneous Post Feedback Intervention Delivery|Simultaneous PFI delivery after baseline survey
15859928|NCT03962751|Behavioral|Sequential Post Feedback Intervention Delivery|Sequential PFI delivery over 3 weeks after baseline survey
15859929|NCT03962751|Behavioral|Text Message Boosters|Text message boosters on PFI content during week of high risk drinking event
15859930|NCT03962738|Drug|Lasmiditan|Administered orally
15859931|NCT03962738|Drug|Placebo|Administered orally
15859932|NCT03962725|Drug|Neuromuscular Blocking Agents|Use of non depolarizing neuromuscular blocking agents for maintenance of general anesthesia.
15859933|NCT03962725|Drug|Anesthetic Adjuncts|Use of deeper plane of inhaled anesthetics or adjuncts (opioids, propofol, dexmedetomidine or ketamine for maintenance of general anesthesia.
15859934|NCT03962712|Other|Increase Minimum Wage to $15-an-hour|Increase in minimum wage to $15-an-hour
15859935|NCT03962712|Other|No Increase in Minimum Wage|No increase in minimum wage
15859936|NCT03962686|Drug|MetFORMIN 1000 Mg Oral Tablet plus SLGT2i|Patients in the third study cohort will receive for 4 months a 1000 mg metformin oral therapy plus 100 mg SLGT2i oral therapy before to practice surgical intervention for carotid artery obstruction.
15859937|NCT03962673|Radiation|NB-UVB light exposure|Participants are exposed to three low dose Narrow Band UVB light.
15859938|NCT03962660|Other|HaRTS-TRENDS|"HaRTS-TRENDS comprises 4, individual sessions delivered in the context of the interventionist's pragmatic harm-reduction mindset paired with a compassionate, advocacy-oriented heart-set or style. It comprises the delivery of 4 manualized components, including a) participant-led tracking of preferred smoking outcomes, b) elicitation of participants' harm-reduction goals and their progress toward achieving them, c) discussion of the relative risks of various nicotine delivery systems, and d) instruction in using ENDS. Additionally, HaRTS-TRENDS entails provision of commercially available ENDS."
15859939|NCT03962660|Other|Standard Care (SC)|The 4-session, individual standard care control condition entails the well-documented and evidence-based 5 As intervention (i.e., Ask about nicotine use, Assess use, Advise to quit smoking, Assist with exploring current smoking/planning smoking cessation, Arrange follow-up). Part of arranging follow-up is the recommendation to call the smoking quit line, which can supply additional counseling and nicotine replacement therapy.
15859940|NCT03962647|Dietary Supplement|2-Week Ketogenic Diet|2-Week Ketogenic Diet in Combination with Letrozole
15859941|NCT03962647|Drug|Letrozole|2.5 mg taken once daily by mouth
15859942|NCT03962634|Drug|Kovanaze Nasal Spray|Intra-nasal local anesthetic
15859943|NCT03962634|Drug|Articaine Injection|Local anesthetic
15859944|NCT03962621|Radiation|Fotona 4D 1064 nm laser|The 1064 nm laser can penetrate deep into the skin to explode pigment particles, destroy blood vessels and heat the dermal collagen by targeting melanin and haemoglobin.(1) Frac3®: 30-35 J/cm2, 1.6 ms pulse width, 4mm spot size, unilaterally accumulated 2000 shots; and (2) PIANO®: 160 J/cm2, 5s pulse width, spot size 9mm, unilaterally accumulated 20000 shots, to increase and maintain facial skin temperature to 39-40oC.
15859945|NCT03962621|Radiation|Fotona 4D 2940 nm laser|Er:YAG 2940nm have been considered as a good treatment of facial aging, especially in wrinkles.(1) Smooth®: 9-10 J/cm2, 7mm spot size, which is sequentially delivered to upper and lower labial mucosa and buccal mucosa to unilaterally accumulate 5000 shots; (2) SupErficial™: 0.5-1.0 J/cm2, 7mm spot size, a single pass
15859946|NCT03962608|Device|Yaq-001|Study patients will be dosed daily with 8g of product Yaq-001 for a period of 48 weeks. The product will be provided as beads packed in individual sachets intended each for one oral administration. For each patient, the study duration will be up to 54 weeks, including the screening (up to 45 days), treatment (48 weeks) and 7-day follow up period.
15859948|NCT03962582|Device|Matrix back|The Matrix back will replace the individual's back and the measures will be taken.
15859949|NCT03962556|Other|bimanual palpation|bimanual palpation....i..
15874276|NCT03848767|Device|AID System|AID System
15859951|NCT03962517|Device|with Gait Enhancing and Motivating System-Hip (GEMS-H)|"The intensity of training: between 12 and 16 in borg's rating of perceived exertion scale.
~Assessments consist of gait function, cardiopulmonary metabolic energy cost, physical performance, balance, physical level, pain, fall efficacy, depression, quality of life and activities of daily living."
15859952|NCT03962517|Other|without Gait Enhancing and Motivating System-Hip (GEMS-H)|The intensity of training: between 12 and 16 in borg's rating of perceived exertion scale.
15859953|NCT03962504|Behavioral|trauma-focused treatment|cognitive behavioral treatment for posttraumatic stress disorder that consists of exposure to the trauma memory.
15859954|NCT03962491|Behavioral|Daily Self-Monitoring Surveys + Contingency Management|Asked to complete a brief (5-minute) survey with questions related to pain experience and related measures every day for 28 days using the DynamiCare smartphone app, with the opportunity for monetary rewards for completing daily surveys.
15859955|NCT03962491|Behavioral|Daily Self-Monitoring Surveys|Asked to complete a brief (5-minute) survey with questions related to pain experience and related measures every day for 28 days using the DynamiCare smartphone app.
15859956|NCT03962478|Device|biliary stent and high-intensity focused ultrasound ablation system|Self-expandable biliary nitinol alloys stent and YDME FEP-BY02 high-intensity focused ultrasound equipment
15859957|NCT03962478|Device|biliary stent|Self-expandable biliary nitinol alloys stent
15859958|NCT03962465|Drug|Inotuzumab ozogamicin|By IV, given on days 12 and 19 Inotuzumab ozogamicin is approved as a single-agent in this population (patients with B-ALL) but adding it to these drug combinations has not been tested in humans
15859959|NCT03962465|Drug|Prednisone Pill|Taken daily days 1-28 by mouth
15859960|NCT03962465|Drug|Daunorubicin|By IV, given on days 1, 8, 15, and 22
15859961|NCT03962465|Drug|Vincristine|By IV, given on days 1, 8, 15, and 22
15859962|NCT03962465|Drug|Cytarabine|Intrathecal, administered on day 1 only
15859963|NCT03962465|Drug|Methotrexate|Intrathecal, administered on days 8 and 29
15859964|NCT03962465|Drug|Pegaspargase|By IV, given on day 4
15859965|NCT03962452|Genetic|Next Generation Sequencing (NGS)|Determining the nucleic acid sequence
15859966|NCT03962439|Behavioral|High-Demand Photography|The high-demand photography group will receive 2.5 hours of instruction, twice a week, in a structured high-demand digital photography course plus 10 hours per week working on a special project at the research site without any formal instruction.
15859967|NCT03962439|Behavioral|Moderate-Demand Photography|The moderate-demand photography group will receive 2.5 hours of instruction, twice a week, in a structured moderate-demand digital photography course plus 10 hours per week working on a special project at the research site without any formal instruction.
15859968|NCT03962439|Behavioral|At-Home Engagement|The placebo control group will engage, alone at home, in tasks that are relatively low in intellectual engagement such as listening to music and radio or completing work-books that rely primarily on activation of knowledge.
15859969|NCT03962426|Device|SocialVille Social Cognitive Training|"SocialVille exercises in this study include 4 exercises:
~Recognition: a speeded face matching task
~Face to Face: a speeded facial emotion matching task
~Gaze Match: a speeded gaze matching task
~Face Poke: a continuous performance task with facial expressions"
15859970|NCT03962413|Procedure|Endoscopic Approaches To Maxillary Sinus|"The first group (group A):
~The middle meatal antrostomy approach.
~The second group (group B):
~The endoscopic prelacrimal recess approach
~The third group (group c):
~The canine fossa approach."
15859971|NCT03962400|Procedure|Reinforcement Learning|New computer based procedure for determining dose using a decision support tool
15859972|NCT03962400|Procedure|Heath Care Provider|Warfarin dose will be determined by a qualified health care provider
15859973|NCT03962387|Other|Not applicable(observational study)|Not applicable(observational study)
15859974|NCT03962374|Device|Frova|Frova will be used to facilitate the endotracheal intubation. The success rate of first attempt of intubation will be assessed.
15859975|NCT03962374|Device|Stylet|Stylet will be used to facilitate the endotracheal intubation. The success rate of first attempt of intubation will be assessed.
15859976|NCT03962361|Other|Concentration of circulating microparticles.|The microparticles contained in the blood sample will be isolated by ultracentrifugation and quantified by flow cytometry. The microparticles concentration will be determined by the number of microparticles per uL of plasma, based on the volume of the sample, the flow rate of the cytometer and the number of fluorescent events.
15859977|NCT03962348|Behavioral|Targeted Educational Campaign|"Correction Officers will be exposed to the Targeted Educational Campaign (TEC) with the aim to increase their knowledge about the early symptoms of psychosis, and how to make a referral to the CHS staff, their self-efficacy to detect symptoms of psychosis and make referrals, and their expectations about their ability to be successful in making that referral (and for referrals to result in beneficial outcomes).
~Correction Officers will be approached and recruited during roll call and in the staff canteen where they take their meal breaks, or at a time/location agreed upon by the Department of Correction, to complete brief surveys at three different times: pre-exposure, after 6 months, and after 12 months from the beginning of the TEC."
15859978|NCT03962348|Behavioral|Specialized Early Engagement Team|The Specialized Early Engagement Team (SEET - a Social Worker and Peer Specialist) will link detainees with first-episode psychosis (FEP), using tenets of person-centered treatment and shared decision-making, and the Critical Time Intervention model, to community-based Coordinated Specialty Care (CSC).
15859979|NCT03962335|Behavioral|Vegetarian diet|7-days dietary profile with a Vegetarian diet (VD), containing inulin and resistant starch-rich foods and including no meat and fish, but containing eggs and dairy, for 3 months
15859980|NCT03962335|Behavioral|Mediterranean diet with butyrate|7-days dietary profile with Mediterranean diet with oral supplementation with butyrate (MD+Bt), 2 g/day, for 3 months
15859981|NCT03962335|Behavioral|Mediterranean diet|7-days dietary profile with Mediterranean diet (MD), including 2 portions per week of fish and 3 portions per week of fresh and processed meat (2 of which fresh or processed red meat), for 3 months
15860038|NCT03961802|Other|sessions of shoulder rehabilitation|3 sessions of shoulder rehabilitation per week for 3 months (36 sessions)
15860039|NCT03961789|Other|patients undergoing opioid replacement therapy|patients undergoing opioid replacement therapy
15859982|NCT03962322|Other|Weaning TDI|"Patients will be subjected to a spontaneous breathing test (Cpap 5), that consists in applying a positive end-expiratory pressure of 5 cm H2O for 20 minutes.
~A tissue doppler evaluation will then be performed by analyzing the diaphragmatic displacement velocity during inspiration and expiration and calculating the speed of muscles displacement and other derived index of muscle function in the modality of ventilation which precedes the trial, during the SBT and after extubation."
15859983|NCT03962309|Other|Health self-assessment questionnaire|The health self-assessment questionnaire includes questions covering anthropometric, sociodemographics, personal and family health history, life style habits and aspects of the behavioral domain. The questionnaire will be administered as paper format or web-based electronic format according to participants' preferences.
15859984|NCT03962296|Drug|Vitis vinifera extract|Three daily oral doses of 50mg tablets of Vitis vinifera extract(Entelon®, Hanlim Pharm, Seoul, South Korea) were administered to patients in this group
15859985|NCT03962296|Drug|Calcium Dobesilate|Three daily oral doses of 50mg tablets of Calcium Dobesilate(Doxium®, Ilsung Pharm, Seoul, South Korea) were administered to patients in this group
15859986|NCT03962296|Drug|Placebo|Placebo tablets lacked Vitis vinifera extract or calcium dobesilate, but their appearance was identical to those of the study group tablets.
15859987|NCT03962283|Drug|Rifaximin|Rifaximin 200mcg four times daily
15859988|NCT03962283|Drug|Placebo oral tablet|Placebo Rifaximin four times daily
15859989|NCT03962270|Device|shock wave device|The experimental group (group ESWT) guided by ultrasound: conventional rehabilitation training is given priority to with strength training, application of pain when necessary, under the guidance of ultrasound ESWT treatment control group (routine rehabilitation group) : conventional rehabilitation training is given priority to with strength training, oral pain when necessary, under the guidance of ultrasound ESWT treatment (shock energy flow density of 0)
15859990|NCT03962257|Other|EngagedMD online learning platform|The EngagedMD online learning platform is a compilation of learning modules and questions designed to give patients at-home access to visual and audio aids in infertility treatment. It also gives patients the ability to read and sign consents from home.
15859991|NCT03962244|Device|EsoSponge|Endoscopically placed an EsoSponge for Negative pressure wound therapy in the area of the esophagogastric anastomotic leaks
15859992|NCT03962244|Device|Self-Expanding Metal Stent|Endoscopically placed self-expanding-metal-stent (SEMS) for negative pressure wound therapy in the area of the esophagogastric anastomotic leaks
15859993|NCT03962231|Other|Rotator Cuff Unloading Exercise Program|Patients in this group will perform semi-closed kinetic chain elevation exercises, deltoid reeducation exercises, assisted arm elevation and scapular control exercises.
15859994|NCT03962231|Other|Rotator Cuff Loading Exercise Program|Patients in this group will perform conventional exercises focusing on lateral rotation, medial rotation and arm elevation.
15859995|NCT03962218|Procedure|aquatic physiotherapy|specific aquatic physiotherapy 3 times a week, for 6 weeks, including feet balance exercises (Rating of Perceived Effort (RPE)), slow walking in all directions, walking with obstacles, Ai Chi, exercises of muscular strength. Each session duration is of 40 minutes.
15859996|NCT03962205|Behavioral|cognitive-behavioral life style intervention|Cognitive Behavioral life-style modification: The intervention will be composed of 12 weekly sessions. Each session will last about two hours and will be administered in a group setting (maximum 20 participants). During the first two sessions, a clinician will introduce the program to the participants and motivate them to make life-style changes.In the next eight sessions a dietician will provide participants with basics of nutrition and will coach them to use a structured diary to monitor their eating behavior and physical activity. Next, a physician will introduce to the patients various weight loss surgeries in terms of the adverse events, indications and effects of each option.The last session will be held by a psychologist and will focus on providing participants with useful strategies to promote healthy eating habits and physical activity, including problem solving and goal setting.
15859997|NCT03962205|Behavioral|wellbeing intervention|This program will consist of 4 weekly group-based sessions and each meeting will last about two hours. During the sessions, participants will be coached how to self-monitor their well-being episodes in everyday life, especially those associated with life-style change, by means of a structured diary. Patients will be then ecounraged to discuss their well-being experiences during group sessions, focusing on dysfunctional thoughts/beliefs interrupting them, fostering the identification of more functional thoughts. The psychologist will also teach them how to promote well-being situations through behavioral exercises and will introduce to the participants relevant psychological well-being dimensions (based on Carol Ryff's multidimensional model) associated with patients' experiences emerged during the treatment.
15859998|NCT03962205|Other|treatment as usual|The treatment as usual will involve any recommendation given to the participants by their physicians, including diet, physical activity and medication.
15859999|NCT03962192|Other|Attitudinal measures|A collection of 3 distinct attitudinal instruments comprise this survey.
15860000|NCT03962179|Device|VACStent|Evaluation of the suitability of the medical device for sealing leaks in the gastrointestinal tract
15860001|NCT03962153|Diagnostic Test|Obstetric Ultrasonography|Obstetric Ultrasonography
15860002|NCT03962127|Other|no intervention|no intervention
15860003|NCT03962114|Dietary Supplement|Vitamin B3|capsules with niagen
15860004|NCT03962101|Drug|OPC-61815 injection|Intravenous administration of OPC-61815 at 8 mg or 16 mg once daily for a maximum of 5 days. Starting with 8mg, increase the dose to 16mg on Day 2 or Day 3, according to the dose escalation criteria.
15860005|NCT03962088|Diagnostic Test|miRNA|"15 ml of whole blood samples are collected in Vacutainer tubes with spray-coated K2EDTA and stored at room temperature. To minimize the hemolysis and nucleic acids degradation, plasma separation undergoes within 2 h.
~Within 1 h, tubes are subjected to a first centrifugation step at 2200 x g and room temperature for 15 min. Plasma supernatants are transferred to 15 mL tubes, carefully avoiding contact with the lymphocytic ring, and tubes are centrifuged a second time at 3000 x g and RT for 10 min to remove cellular debris.
~Plasma samples are then collected into 1.5 mL cryovials and all the aliquots are stored at -80 °C."
15860040|NCT03961776|Device|MRI-guided radiotherapy by on-board DWI sequences|The radiotherapy treatment will be delivered on the MRI-guided radiotherapy platform. The on-board DWI sequences will be performed every three fractions in addition to the treatment session and will last approximately 3-4 minutes.
15876665|NCT03830281|Drug|Insulin Lispro|Administered SC
15860006|NCT03962075|Procedure|laparoscopic paravaginal repair|Using a 10mm laparoscope, with video camera, was introduced through the umbilical trocar. Another 5 mm in suprapubic area and two 10 mm trocars in right and left lateral abdominal sides were introduced. The larger trocar was needed to accommodate the passage of needles into the abdomen. Spacing of trocars sufficiently from each other was needed to facilitate laparoscopic suturing. Transperitoneal approach to retropubic space was used. Two to four polypropylene sutures were applied on each side. Sutures were tied with intracorporeal technique
15860007|NCT03962062|Drug|Moxidectin|2 mg tablets
15860008|NCT03962049|Drug|Linzagolix|A single dose of 200 mg linzagolix (2 tablets of 100 mg) will be administered orally under fasting conditions
15860009|NCT03962036|Device|Bispectral index monitor|BIS monitor is a novel measure of the level of consciousness by algorithmic analysis of a patient's electroencephalogram during general anesthesia.
15860010|NCT03962023|Other|Echocardiography and MRI|Analysis of echocardiography and MRI parameters
15860011|NCT03962010|Drug|GX-G6|long acting anti-diabetic drug
15860012|NCT03962010|Drug|Control|Control
15860013|NCT03961997|Drug|Lorlatinib 50 mg|Participants will receive a single dose of lorlatinib 50 mg in Period 1. Participants will receive modafinil 400 mg daily for 19 days, and a single dose of lorlatinib 50 mg on Day 15 of Period 2.
15860014|NCT03961997|Drug|Lorlatinib 75 mg|Participants will receive a single dose of lorlatinib 75 mg in Period 1. Participants will receive modafinil 400 mg daily for 19 days, and a single dose of lorlatinib 75 mg on Day 15 of Period 2.
15860015|NCT03961997|Drug|Lorlatinib 100 mg|Participants will receive a single dose of lorlatinib 100 mg in Period 1. Participants will receive modafinil 400 mg daily for 19 days, and a single dose of lorlatinib 100 mg on Day 15 of Period 2.
15860016|NCT03961984|Procedure|Biodesign® anal fistula plug|Patient in general anesthesia and lithotomy position. Mucosa excision of the internal fistula opening is performed. The plug was prepared in 0.9% sodium chloride, and secured to the endoluminal brush by a suture with a 2-0 vicryl tie. The narrow end of the of the plug was then pulled through the internal opening into the fistula tract. The plug was pulled until it covered the whole length of the fistula and blocked the internal opening, the excess plug material coming out through the external opening. The plug was fixed at the internal opening by reabsorbable 3-0 sutures. Special attention was paid to ensuring that the plug was covered by mucosa when closing the internal opening. The excess plug material was trimmed by the external opening that was left open for drainage.
15860017|NCT03961971|Drug|MBG453|Patients receive MBG453 and spartalizumab IV over 30 minutes on Day 1. Patients then undergo stereotactic radiosurgery on Day 8. Courses with MBG453 and spartalizumab repeat every 28 days in the absence of disease progression or unacceptable toxicity.
15860018|NCT03961958|Drug|Propofol reduction|Reduction of propofol target concentration
15860019|NCT03961945|Device|Sponge Capsule|Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.
15860020|NCT03961932|Drug|Linzagolix|A single dose of 200 mg linzagolix (2 tablets of 100 mg) will be administered orally under fasting conditions
15860021|NCT03961919|Drug|Fludarabine|Fludarabine i.v. 30 mg/m²/d day -6 to -2
15860022|NCT03961919|Drug|ARA-C|Cytarabine i.v. 2 g/m²/d day -6 to -2
15860023|NCT03961919|Drug|Treosulfan|Treosulfan i.v. 10 g/m²/d day -6 to -4
15860024|NCT03961919|Procedure|Peripheral Blood Stem Cell Transplant|"Autologous stem-cell transplantation i.v.: day 0 (source: peripheral blood)
~Pegylated-Filgrastim s.c. 6 mg day +3"
15860025|NCT03961906|Behavioral|physiotherapy|Will receive two trainings. First training in week one after baseline assessment for three consecutive days 60 min twice daily by trained physiotherapists and in week three further two days with 60min once daily.
15860026|NCT03961893|Device|G-EYE first and standard colonoscope|Patients undergo two successive colonoscopies, first balloon-assisted colonoscopy (G-EYE device) and then standard colonoscopy
15860027|NCT03961893|Device|standard colonoscope first and G-EYE|Patients undergo two successive colonoscopies, first standard colonoscopy and then balloon-assisted colonoscopy (G-EYE device)
15860028|NCT03961867|Drug|Docetaxel|"S-1 (BSA <1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; >1.5m2,120 mg) divided into two doses /day after breakfast and dinner, 14 days / 3 weeks, totally 16 cycles.
~Docetaxel 40mg/m2/3w from the second to the seventh cycles."
15860029|NCT03961867|Drug|Oxaliplatin|"S-1 (BSA <1.25m2, 80 mg; 1.25 to 1.5m2, 100 mg; >1.5m2,120 mg) divided into two doses /day after breakfast and dinner, 14 days / 3 weeks, totally 16 cycles.
~Oxaliplatin 130mg/m2/3w from the first to the eight cycles."
15860030|NCT03961854|Drug|L. johnsonii Probiotic|Participants will consume one capsule of L. johnsonii probiotic daily for 24 weeks.
15860031|NCT03961854|Drug|Placebo Capsule|Participants will consume one capsule of placebo capsule of dried skim milk daily for 24 weeks.
15860032|NCT03961841|Radiation|chemoradiation with weekly 5Fu and oxaliplatin|5Fu 225 mg/m2 IV daily continuous infusion；oxaliplatin 40 mg/m2/week
15860033|NCT03961841|Drug|Perioperative mFLOT|Perioperative docetaxel 50mg/m2；oxaliplatin 85 mg/m2; 5Fu 2.4g/m2 civ 48 hours; repeated every 2 weeks; total of 8 cycles
15860034|NCT03961841|Drug|Perioperative FOLFOX|Perioperative oxaliplatin 85 mg/m2; 5Fu 2.8g/m2 civ 48 hours; repeated every 2 weeks; total of 12 cycles
15860035|NCT03961828|Drug|Ledipasvir 90 MG / Sofosbuvir 400 MG [Harvoni]|The fifty (50) thalassemic children infected with HCV received the new direct-acting antiviral therapy in the form of Ledipasvir (90 mg)/Sofosbuvir (400 mg); (Harvoni) as a single oral tablet /day for 12 weeks Follow up of these patients was performed for 24 weeks. Re-evaluation of these children after 24 weeks from initiation of Ledipasvir/Sofosbuvir treatment was performed by repeating clinical assessment, Fibroscan of liver , laboratory investigations including quantitative HCV RNA by PCR and serum hyaluronic acid measurement.
15860036|NCT03961815|Drug|Brazikumab Induction Dose|Participants who have not responded to treatment and have met criteria for rescue therapy prior to Week 52 in the lead-in study D5271C00001 (Legacy #3150-301-008) are considered inadequate/non responders, and will receive intravenous induction dosing with brazikumab at Week 0, Week 4, and Week 8 followed by maintenance dosing of brazikumab subcutaneously every 4 weeks thereafter up to Week 52.
15860037|NCT03961815|Drug|Brazikumab Maintenance Dose|Responders and completers in the lead-in study D5271C00001 (Legacy #3150-301-008) will receive maintenance dose of brazikumab administered subcutaneously every 4 weeks through Week 52, starting at Week 0. The subcutaneous dose of brazikumab will be administered to all responders/completers in the lead-in study regardless of the prior treatment administered.
15860041|NCT03961763|Dietary Supplement|EPA+DHA|4 g/day EPA+DHA in tablets of 1g, 4 tablets daily, over 8 weeks (56 days)
15860042|NCT03961763|Other|Placebo|4 g/day olive oil placebo in tablets of 1g, 4 tablets daily, over 8 weeks (56 days).
15860043|NCT03961750|Other|OTAGO|12 Week exercise class programme
15860044|NCT03961737|Procedure|prostate biopsies|"Before radiotherapy treatment, prostate biopsies will be performed in each patient. From these biopsies, explants will be performed. Half of these explants will be irradiated ex vivo and the other half will not receive any prior treatment.
~Then the patient will receive radiotherapy. It will be reviewed 2 years after the end of radiotherapy. New prostate biopsies will be performed to evaluate the tumor response to radiotherapy and to characterize the immunohistochemical and transcriptomic profiles of non-responder patients."
15860045|NCT03961724|Device|magnetic resonance image (MRI)|serum metabolomics
15860046|NCT03961711|Procedure|Telemedicine|Patients will undergo a Telemedicine encounter with the physician at the 3-week post-operative timepoint following a total hip or total knee arthroplasty.
15860047|NCT03961711|Procedure|In-Person Clinic Visit|Patients will undergo an in-person clinic encounter with the physician at the 3-week post-operative timepoint following a total hip or total knee arthroplasty.
15860048|NCT03961698|Drug|IPI-549 (eganelisib)|IPI-549 is an oral, selective inhibitor of phosphoinositide-3-kinase gamma (PI3K-gamma). It is an orally-administered capsule that will be dosed at either 20mg/day, 30mg/day, or 40mg/day to patients in both cohorts A and B depending on the results of the safety run-in phase for each cohort.
15860049|NCT03961698|Drug|Atezolizumab|Atezolizumab is a fully humanized, engineered monoclonal antibody of IgG1 isotype against the protein programmed cell death-ligand 1 (PD-L1). 840 mg of the drug will be administered intravenously (IV) on days 1 and 15 in combination of each 28-day cycle for patients with TNBC. 1200mg will be administered IV on day 1 of each 21-day cycle to patients with RCC.
15860050|NCT03961698|Drug|nab-paclitaxel|Nab-paclitaxel is a nanoparticle albumin-bound formulation of paclitaxel (Taxol), a mitotic inhibitor chemotherapy, with less toxicity than solvent-based (sb) paclitaxel and achieves a 33% higher tumor uptake in preclinical models. Nab-paclitaxel will be administered intravenously (IV) at 100 mg/m2 on days 1, 8 and 15 of each 28-day cycle for patients with TNBC.
15860051|NCT03961698|Drug|Bevacizumab|Bevacizumab is an anti-vascular endothelial growth factor (anti-VEGF) recombinant monoclonal antibody that is approved by the FDA for the treatment of multiple solid tumors in combination with chemotherapy. It will be administered at 15 mg/kg IV on day 1 of each 21-day cycle to patients with RCC.
15860052|NCT03961672|Drug|Duvelisib|Given PO
15860053|NCT03961659|Drug|Liraglutid|Liraglutid will be titrated from 0.6mg/day to 1.8mg/day during the first 2 weeks, if well tolerated. All patients will also continue on their existing dose and regimen of metformin throughout the study.
15860054|NCT03961659|Drug|Dapagliflozin|Dapagliflozin will be initiated and maintained at 10mg/day every morning until the completion of the study. All patients will also continue on their existing dose and regimen of metformin throughout the study.
15860055|NCT03961659|Drug|Acarbose|Acarbose will be initiated at 50mg three times daily for the first week, and then titrated to 100mg three times daily if appropriate.All patients will also continue on their existing dose and regimen of metformin throughout the study.
15860056|NCT03961633|Behavioral|AWARE intervention|"will attend the AWARE group counseling sessions, which are 90 minutes, once a week, for 8 weeks. Each week's session is focused on a specific theme related to the cultural and gender-specific issues typical among young Asian American women. The sessions are led by staff therapists at either institution. For more info on each session's content, please see the Study Description - Detailed Description section.
~Participants will fill out forms that detail their therapeutic goals (commitments) and any adverse emotional / behavioral events from the past week. Participants will also receive daily text messages that reinforce the group session themes."
15860057|NCT03961620|Device|The SpotOn system that encompasses the registration unit (3M SpotOn Control Unit), disposable sensor (3M SpotOn Control Sensor) along with the cords and electric power unit.|Patients submitted to major surgical procedure will be assessed for core body temperature by employing SpotOn sensor device, before, during and after surgical procedure.
15860058|NCT03961607|Procedure|Aminolevulinic acid photodynamic therapy|Aminolevulinic acid photodynamic therapy
15860059|NCT03961594|Other|expansion volémique|cardiac output, VVP, VVE, blood pressure, Eadyn, EtCO2 will be measured before and after ELJP. In the event of an increase of more than 10% in cardiac output during the ELJP, patients will receive a volume expansion of 500ml of balanced crystalloids. The same measurements will be repeated immediately at the end of the volume expansion and 20 minutes after the end of the infusion. Patients with a 15% increase in cardiac output at the end of volume expansion will be classified as responders.
15860061|NCT03961568|Drug|Cenobamate|active drug
15860062|NCT03961555|Biological|SYN023|it is administered by direct injection into the wound or by subcutaneous or intramuscular injection when this is not possible
15860063|NCT03961555|Biological|HRIG (HyperRab)|it is administered by direct injection into the wound or by subcutaneous or intramuscular injection when this is not possible
15860064|NCT03961555|Biological|Rabies vaccine|it should be administered in deltoid muscle
15860065|NCT03961542|Other|Chewing|Eligible patients are randomized to receive either routine care (control group) or routine care in addition to a chewing gum intervention for five days (beginning with the second study day, i.e. the day after baseline examination): sugar-free, fruit or mint flavoured gum chewed three times daily for 20 minutes before each meal. Routine care includes standard dietary and lifestyle advice for 30 minutes following our local recommendations as well as an advice on capillary blood glucose measurement (fasting as well as 1h after starting each meal). Capillary blood glucose profiles are reevaluated seven days after starting the blood glucose monitoring. Study visits will be scheduled at screening (visit 1, where eligible patients were randomized) as well as seven days later (visit 2).
15860066|NCT03961529|Drug|0.3% OPA-15406 ointment|Twice daily
15860067|NCT03961529|Drug|1% OPA-15406 ointment|Twice daily
15860068|NCT03961516|Device|Frequently Sampled Oral Glucose Tolerance Test and CGM|Patients will undergo a 2 hour frequently sampled oral glucose tolerance test while wearing an active FreeStyle Libre Pro sensor
15860069|NCT03961516|Radiation|MRI Pancreas and Liver|Patients will undergo an MRI of the pancreas and liver
15860070|NCT03961503|Drug|Daptomycin (DAP) treatment|Group DAP : Daptomycin was administered at a dose of 8 mg/kg in thirty-minutes intravenous infusion every 24 hours in patients without severe impairment of kidney function or every 48 hours in case of GFR below 30 ml/min/m2. The creatine-kinase (CK) level was measured before the initiation of DAP and at least once a week to assess the occurrence of muscular toxicity defined by an increase of CK up to 3-fold the upper superior limit without any evidence of member ischaemia.
15860071|NCT03961503|Drug|Vancomycin (VAN) treatment|Group VAN : Vancomycin intravenous treatment was initiated by a loading dose of 30 mg/kg in 1 hour and followed by a continuous maintenance infusion dosing between 15 and 30 mg/kg/d. The VAN dose was adapted to achieve a target serum vancomycin steady-state concentration of 20-30 mg/L assessed by a daily pharmacologic monitoring (therapeutic drug monitoring).
15860072|NCT03961490|Other|No interventional study|No interventional study
15860073|NCT03961477|Other|Interferential therapy|Exercise therapy
15860074|NCT03961464|Drug|d-cycloserine|Single dose
15860075|NCT03961464|Drug|Placebo|Single dose
15860076|NCT03961451|Device|Podometer|Patients will be equipped with pedometers for 8 weeks, all day and must complete the number of steps each day. They will have to complete online evaluation questionnaires regularly. The main objective is to correlate the level of physical activity with the level of fatigue, quality of life and well-being weekly during an anticancer treatment.
15860077|NCT03961438|Biological|ConM SOSIP.v7 gp140, adjuvanted with MPLA liposomes|Vaccine administration will be done at months 0, 2 and 6 by intramuscular injection into the deltoid muscle of the non-dominant arm. The immunogen will be used at the dosage of 100 μg and will be admixed with 500 μg MPLA formulated in liposomes.
15860078|NCT03961438|Biological|ConM SOSIP.v7 gp140, adjuvanted with MPLA liposomes|Vaccine administration will be done at months 0, 2 and 6 by intramuscular injection into the deltoid muscle of the non-dominant arm. The immunogen will be used at the dosage of 100 μg at months 0 and 2, and 20 μg at month 6. All immunogen dosages will be admixed with 500 μg MPLA formulated in liposomes.
15860079|NCT03961425|Behavioral|NO CO2|Traditional mechanical Deairing
15860080|NCT03961425|Device|CO2 Cannula|NON specific, low cost delivery system
15860081|NCT03961425|Device|CO2 Cardia|Specific Commercial CO2 Diffuser
15860082|NCT03961412|Behavioral|family-based intervention|The participants will identify their accompanying influential person(s) (e.g., spouse, partners, parents, children, friends) with whom they will be attending the 1.5-2 hour face-to-face education session on cervical cancer and screening. At the end of the intervention, time will be allowed for questions, as well as distributing fridge magnets and a pamphlet. Fridge magnets contain Pap test guidelines and availability of local clinics. The pamphlet covers the following topics: (a) information about female anatomy and cervical cancer, (b) risk factors for cervical cancer, (c) facts of cervical cancer incidence and mortality, and screening rates among American women, (d) methods to reduce cervical cancer (e.g., HPV vaccination), (e) Pap test procedure, (f) Pap test guidelines, and (g) availability of clinics and cost of Pap test. The participants will be encouraged to spread the message to family members and friends.
15860083|NCT03961412|Behavioral|Participant only intervention|Only participant will attend the 1.5-2 hour face-to-face education session on cervical cancer and screening. At the end of the intervention, time will be allowed for questions, as well as distributing fridge magnets and a pamphlet. Fridge magnets contain Pap test guidelines and availability of local clinics. The pamphlet covers the following topics: (a) information about female anatomy and cervical cancer, (b) risk factors for cervical cancer, (c) facts of cervical cancer incidence and mortality, and screening rates among American women, (d) methods to reduce cervical cancer (e.g., HPV vaccination), (e) Pap test procedure, (f) Pap test guidelines, and (g) availability of clinics and cost of Pap test. The participants will be encouraged to spread the message to family members and friends.
15860084|NCT03961399|Device|Abbott Medical® CRT device with SyncAVTM stimulation function|patients with Abbott Medical® CRT device will be randomized and SyncAVTM stimulation will be activated.
15860085|NCT03961399|Device|Abbott Medical® CRT device with biventricular stimulation (BiV)|patients with Abbott Medical® CRT device will be randomized and biventricular (BiV) stimulation will be activated.
15860086|NCT03961386|Behavioral|FallsTalk-C|The FT-C experimental intervention involves two face-to-face visits including Initial and Follow-up Interviews, CG training, daily interaction with the PwD using a computer with FT-C software, weekly check-in calls, weekly postcard completion and monthly check-in calls for at least six months and up to one year.
15860087|NCT03961386|Behavioral|FallsTalk|The FallsTalk intervention involves two face-to-face visits including Initial and Follow-up Interviews,CG training, daily interaction with the PwD, weekly check-in calls, weekly postcard completion and monthly check-in calls for at least six months and up to one year.
15860088|NCT03961373|Procedure|Gastrectomy with D2 lymphadenectomy|Patients who are assigned to the neoadjuvant chemotherapy+ surgical D2 treatment group will undergo either subtotal or total gastrectomy, depending on the location of the primary tumour. Standardized D2-lymph node dissection is required with specific information about lymph node stations.
15860089|NCT03961373|Procedure|Gastrectomy with D2plus lymphadenectomy|Patients who are assigned to the neoadjuvant chemotherapy + surgical D2+ extended lymphadenectomy treatment group will undergo either subtotal or total gastrectomy, depending on the location of the primary tumour. Standardized D2+ lymph node dissection plus resection of stations 8p, 12p, 13, 14v, 16a2/b1 is required with specific information about lymph node stations.
15860090|NCT03961360|Drug|Aspirin 81 mg|Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
15860091|NCT03961360|Drug|Aspirin 162 mg|Low dose aspirin was initially reported as having a beneficial effect at preeclampsia
15860092|NCT03961347|Drug|L. johnsonii Probiotic|Participants will consume one capsule of L. johnsonii probiotic daily for 24 weeks.
15860093|NCT03961347|Drug|Placebo Capsule|Participants will consume one capsule of placebo capsule of dried skim milk daily for 24 weeks.
15860094|NCT03961334|Drug|Dabigatran|150mg 2x/d
15860095|NCT03961334|Drug|Apixaban|5mg 2x/d
15860096|NCT03961334|Drug|Edoxaban|60mg 1x/d
15860097|NCT03961334|Drug|Aspirin|100mg 1x/d
15860098|NCT03961334|Drug|Clopidogrel|75mg 1x/d
15860131|NCT03961048|Drug|Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution bilaterally|Variable initial post-operative dose of 10cc to 40cc bilaterally with a variable programmed dose to be repeated afterward of 10cc to 40cc of 0.2% ropivacaine every 6 hours bilaterally.
15860099|NCT03961321|Radiation|stereotactic mr guided adaptive radiotherapy|Study patients will be treated with an online MR-guided hypofractionated course of radiotherapy in 5 fractions of 7.25 Gy per fraction delivered on the prostate with a simultaneous integrated sparing (SIS) of the urethra with a dose of 32.5 Gy in 5 fractions (6.5 Gy per fraction).
15860100|NCT03961308|Drug|Vedolizumab SC|Vedolizumab SC liquid.
15860101|NCT03961295|Drug|Vedolizumab SC|Vedolizumab SC liquid.
15860102|NCT03961282|Other|Doorway Width Test|The first test consists of Doorway Width. Standard level is a doorway width of 30 inches; Enhanced is doorway width of 36 inches; Co-design allows the participant to adjust the width anywhere from 26 to 48 inches.
15860103|NCT03961282|Other|Door Frame Color Test|The second test consists of Door Frame Color. Standard level is same color (hue) as light-color wall; Enhanced level is same hue but of higher color intensity for contrast; Co-design allows the participant to adjust the color intensity range from lowest (same as wall) to highest intensity (stronger contrast than in Enhanced).
15860104|NCT03961256|Drug|Exenatide SR|Exenatide SR 2 mg subcutaneous (SQ) weekly
15860105|NCT03961243|Biological|YUVA-GT-F901|Lentiviral factor IX gene modified autologous hematopoietic and mesenchymal stem cells
15860106|NCT03961230|Drug|Jueyin granules|Put each bag of medicine in the same amount into the same container, pour about 50 ml of warm water, stir until the particles are basically dissolved, and then add appropriate amount of boiling water to dilute.
15860107|NCT03961230|Drug|Jueyin Granules Placebo|Put each bag of medicine in the same amount into the same container, pour about 50 ml of warm water, stir until the particles are basically dissolved, and then add appropriate amount of boiling water to dilute.
15860108|NCT03961217|Radiation|Radiotherapy|Radiotherapy as part of cancer treatment
15860109|NCT03961204|Drug|Cladribine|Participants will not receive any investigational medicinal product (IMP) in the study. Participants will be eligible who had participated in parent studies 25643 (NCT00213135), 27820 (NCT00641537) and 28821 (NCT00725985) and had received Cladribine tablets or placebo.
15860110|NCT03961191|Diagnostic Test|DNA methylation|DNA methylation for the cervical cytology
15860111|NCT03961191|Diagnostic Test|high-risk HPV|High-risk HPV testing for the cervical cytology
15860112|NCT03961191|Diagnostic Test|TCT|Thin prep liquid-based cytology test for the cervical cytology
15860113|NCT03961178|Diagnostic Test|High-risk HPV|High-risk HPV testing for the cytology of lower genital tract
15860114|NCT03961178|Diagnostic Test|TCT|Thin prep liquid-based cytology test for the cytology of lower genital tract
15860115|NCT03961165|Drug|Butylscopolamine Bromide 20 MG/ML|1 mL Butylscopolamine Bromide 20 mg/mL i.v. Single dose.
15860116|NCT03961165|Drug|Sodium Chloride 9mg/mL|1 mL Sodium Chloride 9 mg/mL i.v. Single dose.
15860117|NCT03961152|Behavioral|PainCoach app|In response to the patient's input of the pain experienced (no pain, bearable pain, unbearable pain, or untenable pain), the app gave advice on pain medication use, exercises/rest and when to call the clinic from day 1 until day 14 after surgery.
15860118|NCT03961139|Other|Method of feeding; continuous feeding OR bolus feeding|"CF: Infants fed through a naso or orogastric tube in a continuous fashion using syringe pump. Each feed cycle is of 4 hours (3 hrs continuous feeding and 1 hour rest). 6 feed cycles in a day.
~BF: Infants fed through a naso or orogastric tube in a gravity dependent bolus feeding every 2-3 hours. Each feed would take approximately 10 minutes."
15860119|NCT03961126|Drug|Injection of autologous fatty tissue associated with autologous platelet-rich plasma.|Patients will receive 2 separate infiltrations for three months by intra and subdermal injection of autologous fatty tissue (20cc) associated with autologous platelet-rich plasma (4cc) in each half vulvar.
15860120|NCT03961126|Drug|Corticosteroids (clobetasol 0.05%)|Patients will receive a maintenance treatment of topical therapy with corticosteroids (clobetasol 0.05%) that will be administered by usual clinical practice.
15860121|NCT03961113|Other|Assessment by questionnaire|"At diagnosis a gerontological evaluation will be carried out including the following tests: ADL, iADL, MNA, SF 36, SPPB, FRIED criteria and GDS. The set of scales and scores of the procedure is commonly used in geriatrics to assess the fragility of the patient.
~A monthly telephone reassessment conducted by an ARC will collect ADL and iADL from the first month to the eleventh month. The end-of-study consultation will be conducted by a geriatrician at the 12th month and will include the following tests: ADL, iADL, MNA, SF 36, the SPPB, the criteria of FRIED and the GDS"
15860122|NCT03961100|Drug|Entrectinib 600 mg (T1)|Test formulation 1 (T1): Multi-particulate formulation 1: entrectinib film-coated mini-tablets
15860123|NCT03961100|Drug|Entrectinib 600 mg (T2)|Test formulation 2 (T2): Multi-particulate formulation 2: entrectinib film-coated mini-tablets
15860124|NCT03961100|Drug|Entrectinib 200 mg (R)|Reference formulation (R): entrectinib hard capsules
15860125|NCT03961100|Drug|Entrectinib 200 mg (T)|Test formulation (T): entrectinib HPMC capsules
15860126|NCT03961087|Drug|Coenzyme Q10|Coenzyme Q10 will be given twice
15860127|NCT03961087|Drug|MECLOFENOXATE|MECLOFENOXATE will be given as 500 mg once daily.
15860128|NCT03961074|Other|Iron deficiency anemia in Chinese pregnant women|Iron deficiency anemia exists in Chinese pregnant women during pregnancy
15860129|NCT03961061|Behavioral|Brenner mFIT (standard care)|Families attend an orientation, in which they are then scheduled for an initial introductory 2-hour intake group session and cooking class; these occur within 2-4 weeks of the orientation. Monthly 1-hour long visits with the dietitian, counselor, and PA specialist are held for 6 months, in which the child and caregiver see the pediatrician. During the 6 months of treatment, they attend 4 group classes, choosing from topics such as meal planning, PA, and parenting. Specialized visits with the PA specialist or dietician are scheduled as pertinent issues arise. Motivational interviewing, modified by Brenner FIT for use with families, is the key to treatment; family counselors are trained in cognitive behavioral therapy, parenting support/mindfulness, and employ these approaches to assist families in developing healthy habits.
15860130|NCT03961061|Behavioral|Brenner mFIT (standard care plus mobile health components)|"Brenner mFIT includes all components of the standard Brenner FIT program in addition to six mobile health components.
~The six mHealth components that will be used in addition to standard Brenner Families in Training program include-
~a mobile-enabled website,
~diet and physical activity tracking apps and physical activity tracker
~tailored self-monitoring feedback
~caregiver podcasts
~animated videos for adolescent patients
~social support via social media."
15861273|NCT03952325|Drug|Pembrolizumab|Pembrolizumab at 200 mg by intravenous infusion Q3W
15860132|NCT03961048|Drug|Ropivacaine 0.2%-Sodium Chloride 0.9% Injectable Solution unilaterally|Variable initial post-operative dose of 10cc to 40cc unilaterally with a variable programmed dose to be repeated afterward of 10cc to 40cc of 0.2% ropivacaine every 6 hours unilaterally.
15860133|NCT03961022|Dietary Supplement|Polyherbal supplement: ReWin(d) vs Placebo|Supplementation during 4 weeks + 72 hours post acute exercice
15860134|NCT03961009|Biological|Kedrion IVIG 10%|Kedrion intravenous immunoglobulin (IVIg) 10%
15860135|NCT03960996|Procedure|dacryocystorinostomy|Dacryocystorinostomy is a surgical procedure indicated in patients with lacrimal duct obstruction.
15860136|NCT03960983|Device|Treatment with tongue scraper|Treatment with tongue scraper. the evaluation of halitosis will be repeated before this step.
15860137|NCT03960983|Procedure|Hygiene procedures for the mucosa and dentures|Hygiene procedures for the mucosa and dentures edentulous participants will be submitted to hygiene procedures for the mucosa and dentures. The evaluation of halitosis will be repeated before this step
15860138|NCT03960983|Radiation|Photodynamic Therapy|Treatment with Photodynamic therapy. The evaluation of halitosis will be repeated before this step
15860139|NCT03960983|Procedure|Hygiene procedures for the mucosa and dentures|Hygiene procedures for the mucosa and dentures edentulous participants will be submitted to hygiene procedures for the mucosa and dentures. The evaluation of halitosis will be repeated before this step
15860140|NCT03960970|Drug|Azithromycin 500 mg|Additional IV Azithromycin 500 mg to Standard Prophylaxis
15860141|NCT03960970|Drug|Mefoxin 2g|Standard Prophylaxis
15860142|NCT03960957|Biological|AbobotulinumtoxinA|Treatment of glabellar facial lines with 50 U AbobotulinumtoxinA
15860143|NCT03960957|Other|Placebo|Treatment of glabellar facial lines with placebo
15860144|NCT03960944|Other|Yoga|30 Min Yoga session included of Physical posture, Breathing exercise, Yoga games and Relaxation.
15860145|NCT03960931|Other|Aquatic rehabilitation|Rehabilitation sessions using hydrophysiotherapy will occur in a pool of Grand Nancy Thermal, three times per week during 4 weeks, and each will last 45 min. They will begin with 10 min of warm-up, then 30 min of walking. Sessions will end cool-down during 5 min, which will be a reduction of intensity every 30 sec. Rehabilitation will be carried out by physiotherapist chosen for the study.
15860146|NCT03960931|Other|Land based physical activities|Rehabilitation sessions on treadmill will occur at Physical Medicine and Rehabilitation Regional Institute (IRR), on the University Hospital's site, three times per week during 4 weeks, and each will last 45 min. They will begin with 10 min of warm-up, then 30 min of walking, where intensity of effort can be modulated by speed and inclination of treadmill. Sessions will end cool-down during 5 min, which will be a reduction of intensity every 30 sec. Rehabilitation will be carried out by physiotherapist chosen for the study.
15860147|NCT03960931|Other|Conventional rehabilitation|Conventional rehabilitation sessions will occur in private practices in which patients receive their habitual care (same physiotherapist). This care will be guided by prescription delivered by the neurologist. This prescription suggests to work on active and passive upper and lower limb stretching, on hip and shoulder dissociation, and balance control management on unstable ground.
15860148|NCT03960918|Behavioral|aerobic exercise therapy|aerobic exercise therapy: All enrolled subjects will perform a CPET before the training initiation. After CPET, the patients in the experimental group need to perform an additional bicycle training program with the intensity of 60 % maximal workload in the previous CPET (five days per week, for four weeks with a total of 20 times).
15860149|NCT03960905|Other|Children with the usage of anti-infective drugs|According to the models of population pharmacokinetics,the investigators and want to correlate use of antibiotics with treatment effectiveness and safety in children.
15860150|NCT03960892|Behavioral|Problem Management Plus (PM+)|This intervention is based on the WHO treatment guidelines for conditions related to stress (WHO, 2013). It is a 5-session intervention that is delivered by trained non-specialists, and is available in individual and group delivery formats for both children and adults. PM+ includes evidence-based techniques such as; problem solving, stress management, behavioral activation, and accessing social support. It has proved to be effective by two randomized controlled trials (RCTs) in Kenya and Pakistan (Bryant, Dawson, Schafer, Sijbrandij, & van Ommeren, 2016; Rahman, Hamdani, Awan, Bryant, Dawson, Khan, Mukhtar-ul-Haq Azeemi, et al., 2016).
15860151|NCT03960879|Diagnostic Test|DNA methylation|DNA methylation for the cervical cytology
15860152|NCT03960879|Diagnostic Test|High-risk HPV|High-risk HPV testing for the cervical cytology
15860153|NCT03960879|Diagnostic Test|TCT|Thin prep liquid-based cytology test for the cervical cytology
15860154|NCT03960866|Drug|Phentolamine Mesylate Ophthalmic Solution 1%|Topical Sterile Ophthalmic Solution
15860155|NCT03960866|Other|Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)|Topical Sterile Ophthalmic Solution
15860156|NCT03960853|Procedure|pressure-controlled ventilation-volume guaranteed|patients will be allocated to pressure-controlled ventilation-volume guaranteed in operation
15860157|NCT03960853|Procedure|volume controlled ventilation|patients will be allocated to pressure-controlled ventilation volume guaranteed in operation
15860158|NCT03960840|Drug|YTB323 and ibrutinib|Single infusion of YTB323 and daily ibrutinib
15860159|NCT03960840|Drug|YTB323 single agent|Single infusion of YTB323
15860160|NCT03960827|Other|Endurance Training|Participants randomized to ET engage in four center-based ET sessions each week for 12 weeks; each session lasting roughly 1-hour with a 40-45 minute stimulus phase and the remaining time being used to warm up and cool down. Each week, two of the sessions occur on a cycle ergometer and two involve treadmill exercise (4 total sessions per week). During all sessions, the participant's heart rate is monitored to ensure they maintain exercise intensity at 70% of heart rate reserve (± 5%). Periodically during training sessions perceptual data from participants are recorded, which is used to track the subjective experience of participants and in interpreting adherence data.
15860184|NCT03960697|Behavioral|walk out from operating room|After the surgery of laparoscopic total or partial nephrectomy， patients will be encouraged to walk out from the operating room and return to the ward by walking under the condition of stable physiological parameters, painlessness, clear consciousness and normal muscle strength of lower limb
15860185|NCT03960684|Device|Levita Magnetic Surgical System|Levita Magnetic Surgical System
15860186|NCT03960671|Drug|Midazolam/diazepam/propofol|Therapeutic drug monitoring of anxiolytics
15876811|NCT03829319|Drug|Carboplatin|IV infusion Q3W
15860161|NCT03960827|Other|Restistance Training|Participants randomized to RT engage in four center-based RT sessions each week for 12 weeks; each session lasting roughly 1-hour with a 40-45 minute stimulus phase and the remaining time being used to warm up and cool down. The prescription is a 2-day split, meaning approximately half of the major muscle groups are exercised each session and each muscle group is exercised twice per week. Two sessions per week include seven exercises that focus on the hips/thighs, back and biceps, and the other two sessions per week include seven exercises that focus on the chest, shoulders, triceps, calves and abdominal muscles. The first set per muscle group is a warm-up performed at 50-70% of prescribed loads that are based on 10-repetition maximum (RM). Three sets per exercise are then performed at 10RM intensity. Load increases when a participant is able to perform 12 repetitions for 2 of 3 sets of an exercise. During all sessions, heart rate is monitored and perceived exertion is recorded.
15860162|NCT03960814|Drug|Insulin detemir|No treatment will be given to the patients in relation to this study. Patients have been included in this study because they have been treated with insulin glargine or detemir prior to study initiation (2004 - 2018) and according to routine clinical practice at that time. The decision to initiate treatment with commercially available insulin detemir and glargine has been made by the patient/Legally Acceptable Representative (LAR) and the treating physician before and independently from the decision to include the patient in this study.
15860163|NCT03960801|Drug|Remifentanil group|bolus intravenous injection of 3 to 4µg/kg of remifentanil after hypnotic administration for a crush anesthetic induction
15860164|NCT03960801|Drug|neuromuscular blockade group|Bolus intravenous injection of 1mg/kg of Succinylcholine or Rocuronium after hypnotic administration for a crush anesthetic induction
15860165|NCT03960788|Drug|Gadoxetate Sodium|Gadoxetate Sodium is an FDA approved contrast agent to be used during magnetic resonance imaging.
15860166|NCT03960775|Drug|dexmedetomidine|Dexmedetomidine infusion (0.4㎍/kg/hr) from anesthetic induction until the start of closure of peritoneum.
15860167|NCT03960775|Drug|saline|Saline infusion during same time period.
15860168|NCT03960762|Other|ESP block (Group ESP)|In group A, ESP block will be performed. US probe will be placed longitudinally 2-3 cm lateral to the T5 transverse process. From superior to inferior, three muscles will be visualized on the hyperechoic transverse process; trapezius (upper), rhomboideus major (middle), erector spinae (lower). The block needle will be inserted cranio caudal direction and then for correction of the needle 5 ml saline will be injected deep into the erector spina muscle fascia. Following confirmation of the correct position of the needle 20 ml %0.25 bupivacaine will be administered for block
15860169|NCT03960762|Other|SAP block (Group SAP)|In group B, after lateral positioning, US probe will be placed in a sagittal plane over the midclavicular region of the thoracic cage. Then the 7th rib will be identified in the midaxillary line, followed by the identification of the following muscles overlying the 6th rib: the latissimus dorsi (superficial and posterior), teres major (superior), and serratus muscle (deep and inferior). The needle will be inserted in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus anterior muscle. 5 ml saline will be enjected for correction. Following confirmation of the correct position of the needle 20 ml %0.25 bupivacaine will be administered for block.
15860170|NCT03960749|Device|Sprotte 25G needle, stylet reinserted|Lumbar puncture with small bore atraumatic needle, stylet reinserted before needle withdrawal
15860171|NCT03960749|Device|Sprotte 25G needle, stylet not reinserted|Lumbar puncture with small bore atraumatic needle, stylet not reinserted before needle withdrawal
15860172|NCT03960749|Device|Sprotte 22G needle, stylet reinserted|Lumbar puncture with larger bore atraumatic needle, stylet reinserted before needle withdrawal
15860173|NCT03960749|Device|Sprotte 22G needle, stylet not reinserted|Lumbar puncture with larger bore atraumatic needle, stylet not reinserted before needle withdrawal
15860174|NCT03960749|Device|Spinocan 25G needle, stylet reinserted|Lumbar puncture with small bore cutting needle, stylet reinserted before needle withdrawal
15860175|NCT03960749|Device|Spinocan 25G needle, stylet not reinserted|Lumbar puncture with small bore cutting needle, stylet not reinserted before needle withdrawal
15860176|NCT03960736|Other|ESP block (Group A)|US probe will be placed longitudinally 2-3 cm lateral to the T5 transvers process. From superior to inferior, three muscles will be visualized on the hyperechoic transverse process; trapezius (upper), rhomboideus major (middle), erector spinae (lower). The block needle will be inserted cranio caudal direction and then for correction of the needle 5 ml saline will be injected deep into the erector spina muscle fascia. Following confirmation of the correct position 20G catheter will be inserted 5 cm in caudal direction. 20 ml %0.25 bupivacaine will be administered for block.
15860177|NCT03960736|Other|TEA group (Group B)|Local infiltration with 2% of lidocaine under the skin, in T4/T5 intervertebral space will be administered. An 18 G Tuohy needle will be inserted at T4/T5 intervertebral space to identify epidural space using the loss of resistance technique. 20G catheter will be inserted 3-4 cm in caudal direction in the epidural space. Bolus dose of 0.125% bupivacaine 10 ml will be administered through the catheter after the negative aspiration for blood or cerebrospinal fluid
15860178|NCT03960723|Other|Questionnaire|A questionnaire asking the patients for several questions related to the Informed Consent Form they have signed before surgery, will be administered.
15860179|NCT03960710|Other|Anonymized CT examinations|The anonymized CT examinations will be reviewed in Lyon, in the imaging department of Edouard Herriot Hospital, by an expert radiologist and an intern from the Lyon hospitals.
15860180|NCT03960710|Other|Training (1)|"An initial training phase of the artificial intelligence network will be carried out :
~- Segmentation of the livers of a first part of the CT examination, by an intern of the Lyon hospitals"
15860181|NCT03960710|Other|Training (2)|"An initial training phase of the artificial intelligence network will be carried out :
~- Use of computer data to drive the artificial intelligence network."
15860182|NCT03960710|Other|Validation (1)|"A validation phase of the artificial intelligence tool will be carried out with segmentation of the livers of the second part of the CT examinations :
~- Carried out by an intern at the Lyon hospitals"
15860183|NCT03960710|Other|Validation (2)|"A validation phase of the artificial intelligence tool will be carried out with segmentation of the livers of the second part of the CT examinations :
~- Carried out by the neural network"
15860267|NCT03959982|Other|Spirehealth Tag Device|Subjects will wear the Spirehealth Tag Device to measure heart rate, respiratory rate, sleep time, physical activity (movement), and calories burned with activity.
15860187|NCT03960658|Drug|ketamine-enhanced prolonged exposure|Subjects will receive a single infusion of racemic ketamine at 0.5mg/kg (ideal body weight) for 40 minutes. The next day, patients will have a standardized prolonged exposure session which lasts approximately 90 minutes. This co-jointed intervention will be repeated for 3 weeks. Then, patients will continue with therapy sessions to complete a total of 10-12 sessions.
15860189|NCT03960632|Diagnostic Test|Abbott SD Bioline Malaria Pf Plus (05FK150) and Abbott SD Bioline Malaria Pf/Pv Plus (05FK160))|Qualitative in vitro tests for the detection of Plasmodium antigens
15860190|NCT03960619|Behavioral|coping skills training|We aim to test a combined coping skills training and activity coaching protocol that: first, is feasible and acceptable, and second, improves physical disability, as well as pain, fatigue, distress, and physical activity in HCT patients. We propose a novel intervention protocol that uses a hybrid in-person and mHealth intervention delivery model.
15860191|NCT03960606|Combination Product|PUR1900|PUR1900 contains itraconazole as the active ingredient, and it is formulated as a dry powder for oral inhalation.
15860192|NCT03960606|Combination Product|Placebo|PUR1900 placebo
15860193|NCT03960593|Other|Evaluation of the influence of geriatric factors|Follow-up of patients> 70 years old with cancer pathologies to evaluate the influence of geriatric factors associated with a review of therapies on their care pathways and health conditions. We will be particularly interested in the main objective, the unplanned hospitalization rate at 3 months in patients> 70 years old with cancer treated in oncogeriatric HDJ before the initiation of oncological treatment such as chemotherapy (oral or intravenous) and / or targeted therapy and / or immunotherapy and / or new generation hormone therapy.
15860194|NCT03960580|Drug|OPN-375|OPN-375, BID
15860195|NCT03960567|Device|Videolaryngoscopy|Patient will be intubated by using videolaryngoscope
15860196|NCT03960554|Drug|Denosumab Inj 60 mg/ml|Treatment will be administered by study personnel as a subcutaneous injection every 6-months for one year.
15860197|NCT03960554|Other|Placebo|Placebo will be administered by study personnel as a subcutaneous injection every 6-months for one year.
15860198|NCT03960541|Drug|CD24Fc (human CD24 extracellular domain and human IgG1 Fc fusion protein)|CD24Fc will be given as IV infusion, 240 mg per infusion, q2w, total 3 doses in 4 week interval.
15860199|NCT03960541|Drug|Saline Solution|Sterile saline solution (0.9% sodium chloride) will be given as placebo with IV infusion, 100 ml per infusion, q2w, total 3 doses in 4 weeks.
15860200|NCT03960528|Procedure|Erector spinae plane block|Bilateral 20 ml Bupivacaine 0.25% + lidocaine 1% injected between erector spinae muscles and transverse process under direct vision.
15860201|NCT03960528|Procedure|Control group|20 ml NaCl 0,9% used for the infiltration between the transverse process and the erector spinal muscle under direct vision on each side.
15860202|NCT03960502|Drug|AG-881|Single oral dose of approximately 50 mg AG-881 (free form) containing approximately 100 microcuries (μCi) of [14C]AG-881.
15860203|NCT03960502|Drug|[13C315N3]AG-881|Single IV microdose of approximately 100 μg.
15860204|NCT03960489|Drug|Roxadustat|Participants will receive single dose of 100 mg azo dye free tablet or mini tablet suspension or solid mini tablet or dye containing tablet.
15860205|NCT03960476|Behavioral|PlanYourLifespan.org|The study intervention is a web-based planning tool, PlanYourLifespan.org
15860206|NCT03960463|Device|Transcu O2®|Participants randomized into study active group will be provided with a Transcu O2® at their surgical site and followed for 4 weeks.
15860207|NCT03960450|Drug|BOS-475|topical cream
15860208|NCT03960450|Drug|Vehicle|topical cream
15860209|NCT03960437|Drug|Etelcalcetide|Administered intravenously at the end of each dialysis session. Dosing ranges from 5 mg to 15 mg set by the patient's physician.
15860210|NCT03960424|Other|Comprehensive Outpatient Management|Patients receiving comprehensive outpatient management experience typical care received in the outpatient setting.
15860211|NCT03960424|Behavioral|Diabetes Telemonitoring|Diabetes Telehealth Management (DTM), based on the 2018 ADA Standards for T2D, uses smart devices to share information between patients, caregivers, and clinicians.
15860212|NCT03960411|Drug|Doxycycline 100Mg Capsule|Doxycycline capsule
15860213|NCT03960411|Drug|Placebo oral capsule|Capsule manufactured to mimic doxycycline 100 mg capsule
15860214|NCT03960398|Drug|Iatrogenic disease impact on emergency consultations|Determination of the proportion of emergency consultations linked to iatrogenic diseases
15860215|NCT03960385|Biological|CYD-TDV|Dengue vaccine
15860216|NCT03960372|Behavioral|ICT activities|Public education activities using ICT to promote family communication, sharing happiness with family members, and well-being in the community.
15860217|NCT03960359|Other|Clinical, microbiological and inflammatory phenotype|Clinical phenotype: temporal pattern of wheeze (EVW, SIW, MTW), history and clinical data, allergy diagnosis work-up Microbiological phenotype: viral status (PCR in nasal swab sample), bacteriological status (culture of induced sputum) Inflammatory phenotype: profile of cytokines, phenotype of immune cells in the blood and the sputum, cytokine response to TLR ligands by peripheral blood mononuclear cells.
15860218|NCT03960346|Procedure|Ablation with cryoenergy|Esophageal temperature-guided ablation using cryoengery and an esophageal temperature probe.
15860219|NCT03960320|Other|questionnaire|questionnaire to assess the quality of life of children using KINDL, SDQ and SF-36
15860220|NCT03960307|Other|Microcirculation and Glycocalyx assessment|Non-invasive assessment of endothelial glycocalyx dimensions (PBR) and microcirculatory parameters (e.g. PPV, PVD, TVD, MFI)
15860221|NCT03960294|Other|DOZE Sleep App|DOZE is an evidence-based cognitive behavioural therapy for insomnia app created specifically for use with adolescents and young adults.
15860222|NCT03960281|Other|Regular dental examination|Regular dental examination, and the patient will be asked to fill a questionnaire
15860223|NCT03960268|Drug|Brodalumab|interleukin 17 receptor A antagonist
15860224|NCT03960255|Other|Normal standard care|Both groups will receive standardized treatment and care for diabetic foot ulcers
15860225|NCT03960229|Other|MicroFluidic Sperm Sorting Chips|sperm selection of IVF treatment
15860226|NCT03960229|Other|Gradient-Density Centrifugation|sperm selection of IVF treatment
15860319|NCT03959592|Other|Placebo|This intervention involves an inert pill (1 pill daily with a meal) that contains only sunflower oil, for six months.
15860227|NCT03960216|Procedure|Scaling and root planning|Patients received non-surgical periodontal therapy in the form of full-mouth scaling and root planing (SRP), in two sessions, 1 week apart, with the use of an ultrasonic scaler (Minipiezon Electromedical Systems EMS, Nyon, Switzerland) and hand instruments, under local anaesthesia.
15860228|NCT03960216|Procedure|Supragingival Prophylaxis|Supragingival removal of all deposits (plaque and calculus) with an ultrasonic scaler in two sessions, 1 week apart.
15860229|NCT03960203|Diagnostic Test|InSight|Clinical decision support (CDS) system for severe sepsis detection and prediction
15860230|NCT03960190|Device|Using Eureka Breast Pump with Expression Kit|Each subject will undergo two expression sessions for single and double electric pumping in randomized order to reduce the variation.
15860231|NCT03960177|Drug|Glucarpidase|Given IV
15860232|NCT03960177|Other|Quality-of-Life Assessment|Ancillary studies
15860233|NCT03960164|Combination Product|Dermal regeneration photosynthetic matrix|Patients with clean wound will receive DRPM over the lesion which will be illuminated by a LEDs array device.
15860234|NCT03960151|Drug|Rolapitant|Rolapitant 180mg PO, Days 1 and 5
15860235|NCT03960151|Drug|Palonosetron|Palonosetron 0.25 mg IV, Days 1,3, and 5.
15860236|NCT03960151|Drug|Olanzapine|Olanzapine 10 mg PO PM, Days 2,3,4,5,6-8
15860237|NCT03960151|Drug|Dexamethasone|Dexamethasone 20 mg AM, Days 1,2 and 3
15860238|NCT03960138|Device|Intermittent Theta-burst stimulation (iTBS)|Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected.
15860239|NCT03960138|Device|Continuous Theta-burst stimulation (cTBS)|Theta-burst stimulation (TBS), a form of repetitive transcranial magnetic stimulation (rTMS), affects brain areas stimulated directly underneath the scalp and brain areas that are functionally connected. Continuous TBS (cTBS) which is thought to temporarily dampen brain activity in that specific area.
15860240|NCT03960125|Device|Photodynamic Therapy|Blue Light Therapy Exposure
15860241|NCT03960125|Drug|4% Imipramine|A tricyclic antidepressant (TCA) medication. Though it is usually taken orally, topical preparations (4%) has use in topical anesthetics and anti-pain medicaments.
15860242|NCT03960125|Drug|Base Cream|Control to 4% Imipramine
15860243|NCT03960112|Device|mpMRI|mpMRI in the detection of prostate cancer in a per patient analysis using cystoprostatectomy specimen
15860244|NCT03960099|Behavioral|Pictograph in Banner and Verification Alert|Patient Pictograph will be displayed in the banner at the top of the screen in the electronic health record AND patient Pictograph displayed in a patient ID verification alert when placing electronic orders in the electronic health record.
15860245|NCT03960086|Other|Podoactiva cutom-made foot orthoses|Children had to use the orthotics daily during the intervention period
15860246|NCT03960086|Other|Podoactiva heel lifts|Children had to use the orthotics daily during the intervention period
15860247|NCT03960073|Dietary Supplement|MitoQ|4 week 20mg oral daily dose of Mito Q
15860248|NCT03960073|Dietary Supplement|Placebo|4 week oral daily dose of TTP placebo
15860250|NCT03960047|Behavioral|Virtual Reality Training|This group gets trained to cross streets using virtual reality
15860251|NCT03960047|Behavioral|Streetside Training|This group is trained to cross streets based on streetside experiences
15860252|NCT03960021|Radiation|RFA interventions|Each patient is treated with 2 RFA interventions. Abiopsy of one metastasis is done at each RF session. Histological samples are sent to the Bio-pathology department of Institut Bergonié for tumor infiltrating lymphocytes counting. Primary outcome results from this counting (stromal TILs ≥ 20% is considered as a significant level, a comparative measurement before and after RF will be performed). In parallel blood samples are performed before and after RFA to analyze the kinetics of peripheral blood T lymphocytes subsets, tumoral circulating cells and tumoral DNA.
15860253|NCT03960008|Radiation|Stereotactic Body Radiation Therapy (SBRT)|SBRT will be delivered in five total fractions, with at a minimum of one day between any two treatments. The entire treatment must be delivered within 15 total days.
15860254|NCT03960008|Procedure|Trans-Arterial Chemoembolization (TACE)|First day will be administered and a second TACE will be administered after 4 weeks and subsequently if imaging is showing disease progression. Following each TACE procedure all patients will remain in hospital for observation
15860255|NCT03960008|Drug|Doxorubin|This procedure will be completed with 2 vials of drug eluting beads each loaded with 50 mg of Doxorubin.
15860256|NCT03959995|Other|High Intensity Resistance (HIT-RT) and Endurance exercise (HIIT)|Ambulatory, consistently supervised group exercise training (3 training sessions of 40-45 min/week each). 10-12-week blocks of non-linearly periodized high intensity resistance and high impact aerobic dance exercises (HIT-setting) intermitted by 4-6-week periods of endurance-type exercise with high volume and lower intensity. Indi-vidualized training schedules for the RT-section.
15860257|NCT03959995|Other|Wellness|control group: 3x 10 week blocks, 1 training session/week à 45 min; stretching, light functional gymnastics, yoga with less strengthening techniques over 13 months.
15860258|NCT03959982|Device|HHHFA Device|Participants will be instructed to use the HHHFA for at least 4 hours during their sleep but will be allowed to use it as long as they want during sleep.
15860259|NCT03959982|Diagnostic Test|Spirometry|Pre and post spirometry using albuterol.
15860260|NCT03959982|Diagnostic Test|6-minute walk|6-minute walk
15860261|NCT03959982|Diagnostic Test|CT scan|CT scan
15860262|NCT03959982|Other|Medical Research Council dyspnea scale (MRC)|MRC questionnaire
15860263|NCT03959982|Other|St. George's Respiratory Questionnaire (SGRQ)|SGRQ questionnaire
15860264|NCT03959982|Other|COPD Assessment Test (CAT)|CAT questionnaire
15860265|NCT03959982|Other|Pittsburgh Sleep Quality Index (PSQI)|PSQI questionnaire
15860266|NCT03959982|Other|CASA-Q|CASA-Q questionnaire
15860268|NCT03959969|Other|Educational video|An educational video on pain management after cesarean section. The educational video was put together by two general obstetrician-gynecologists, two maternal fetal medicine specialists, and a palliative care physician.
15860269|NCT03959969|Other|Standard of care|The standard of care discharge instructions for postoperative patients after cesarean section that are provided at the institution.
15860270|NCT03959969|Drug|Ibuprofen|Prescription given for forty tablets of ibuprofen 600 mg every 6 hours as needed for pain.
15860271|NCT03959969|Drug|Oxycodone|Prescription given for twenty tablets of oxycodone 5 mg every 4 hours as needed for pain.
15860272|NCT03959956|Diagnostic Test|Recording lung sound by a Smartscope|Lung sound will be recorded from four chest points by an electronic stethoscope called Smartscope which can also classify the recorded lung sound.
15860273|NCT03959943|Procedure|Sensory nerve coaptation|A recipient sensory nerve branch of the lateral cutaneous femoral nerve (LCFN) was reattached to a donor nerve in the chest area. The anterior cutaneous branch of the second or third intercostal nerve was used as the donor nerve. Direct, end-to-end nerve coaptation was performed.
15860274|NCT03959930|Device|Transdermal Fluid Removal|"The Transdermal Fluid Removal (TFR) device is designed for use on the lower limbs of patients with Chronic Heart Failure and treatment resistant peripheral oedema.
~The TFR device is intended to be applied on oedematous skin of eligible patients, for periods of up to 10 hours at a time, to gently remove excess fluid through the skin, over a period of a few days during exacerbations, thereby avoiding hospitalisation for intravenous diuretics.
~The TFR device is designed to be used in conjunction with standard Negative Pressure Wound Therapy (NPWT) devices which are currently CE Marked and approved for use in both acute and homecare environment."
15860275|NCT03959917|Procedure|transurethral resection of the prostate|Surgical removal of benign prostatic tissue
15860276|NCT03959904|Procedure|Small stitch|Wound closure will be using small stiches or larger spaced stitches
15860277|NCT03959904|Other|Blood sample|A blood sample to look for biological markers of Hernia formation will be taken
15860278|NCT03959904|Other|Tissue Sample|A tissue sample will be taken to measure markers of wound healing.
15860279|NCT03959904|Other|Pain Score|A pain score will be recorded following the surgical procedure.
15860280|NCT03959904|Other|Quality of Life Score|A Quality of Life Score will be recorded at 1 month 6 months and 12 months post surgery
15860285|NCT03959878|Device|Constant Pressure Skin Disk|The external disk is made of Dow Corning® Silastic Q7-4850 liquid silicone rubber. Placement of the disk will be done by the gastroenterologist or interventional radiologist during the gastrointestinal gastrostomy tube (GIG) or gastrointestinal jejunostomy tube (GIJ) placement procedure. The gastroenterologist or interventional radiologist will replace the manufacturer's external, adjustable skin disk with the external, adjustable Constant Pressure Skin Disk, by sliding the former off and the latter on to the feeding tube.
15860286|NCT03959865|Drug|Long-acting GLP-1RA|Dulaglutide 0.75 or 1.5 mg /week or Exenatide once weekly 2 mg
15860287|NCT03959865|Drug|Short-acting GLP-1RA|Liraglutide 0.6 mg or 1.2 mg or 1.8 mg / day or exenatide 10 mcg or 20 mcg bid or lixisenatide 10 mcg or 20 mcg / day.
15860288|NCT03959865|Drug|Human-based GLP-1RA|Liraglutide 0.6 mg or 1.2 mg or 1.8 mg / day or dulaglutide 0.75 or 1.5 mg / week
15860289|NCT03959865|Drug|Exendin-based GLP-1RA|Exenatide 10 mcg or 20 mcg day or 2 mg / week or lixisenatide 10 mcg or 20 mcg / day.
15860290|NCT03959865|Drug|Fixed ratio BI/GLP-1RA combination|Insulin degludec / liraglutide (0.036/U) or insulin glargine / lixisenatide (0.5 mcg/U)
15860291|NCT03959865|Drug|Flexible BI/GLP-1RA combination|GLP-1RA (Liraglutide or dulaglutide or exenatide or lixisenatide) and basal insulin (BI, glargine, degludec, detemir, NPH insulin)
15860292|NCT03959852|Drug|Fentanyl|1 mg/kg of Fentanyl IV administered over at least 1 minute
15860293|NCT03959852|Combination Product|Fentanyl and Ketamine|Combined dose of 0.15 mg/kg of Sub-dissociative Ketamine and 0.5 mg/kg of Fentanyl IV administered over at least 1 minute.
15860294|NCT03959852|Drug|Ketamine|0.3 mg/kg of Sub-Dissociative Ketamine IV administered over at least 1 minute
15860295|NCT03959839|Procedure|ESD|Rectal Endoscopic Submucosal Dissection
15860296|NCT03959839|Procedure|TAMIS|Transanal Minimally Invasive Surgery
15860297|NCT03959839|Procedure|TEO|Transanal Endoscopic Operation
15860298|NCT03959826|Behavioral|activity contracting|Participants will complete job-related activity contracts each week with the goal of obtaining employment.
15860299|NCT03959826|Behavioral|contingency management for activity completion|Participants will earn chances to win prizes for completing specific job-related activities.
15860320|NCT03959579|Diagnostic Test|systematic endomyocardial biopsy.|"We sought to compare the long term survival of HTx recipients followed with or without systematic endomyocardial biopsy. Second, the sensibility and specificity of cardiac echo to diagnose acute allograft rejection will be analyzed.
~To show the safety of non-invasively monitoring HTx recipients without systematic endomyocardial biopsy"
15860321|NCT03959566|Drug|Sutezolid|Sutezolid is not licensed yet. Current experience in humans up to Phase IIA. Dose according to randomization to dosing arms 2-5.
15860322|NCT03959566|Drug|Bedaquiline, Delamanid, Moxifloxacin|These three licensed drugs form the backbone of a new regimen to which sutezolid is added in arms 2-5.
15860300|NCT03959813|Other|Psychomotricity by touching and passive mobilizations|"The patient will have a first psychomotricity session. It will be carried out remotely from the drug catches to avoid bias induced by their administration having effects on the symptoms studied.
~Before and after the session, two evaluations will be offered to the patient and performed by a nurse:
~A questionnaire, based on the physical experience,
~The ESAS scale will be administered to the patient to assess the importance of symptoms (pain, depression, anxiety, discomfort) During the session, a touch treatment will be offered to promote awareness of the body. Passive mobilizations at the level of the members and the axis will then be proposed, to promote the pleasure of being in motion. A touch treatment will be done again to promote relaxation.
~A questionnaire can be offered to the patient after 4 sessions to assess his perception of psychomotricity."
15860302|NCT03959774|Device|IPC NET|a digital pack with connected bracelet and connected balance will be given to the patient. IPC NET and Nokia Health applications will be downloaded. Pairing between connected objects and the smartphone will be done during the inclusion visit
15860303|NCT03959761|Drug|Intraperitoneal (IP) nivolumab infusion|"Patients will be treated according to three dose-levels of nivolumab, starting 5 to 7 days after surgery + Hyperthermic Intraperitoneal Chemotherapy (HIPEC), through an Intraperitoneal (IP) catheter :
~Level 1 : 0.5 milligrams/kilogram (mg/kg) IP infusion, repeated every 2 weeks for 4 infusions
~Level 2 : 1 mg/kg IP infusion, repeated every 2 weeks for 4 infusions
~Level 3 : 3 mg/kg IP infusion, repeated every 2 weeks for 4 infusions
~Level -1 : 0,3 mg/kg IP infusion, repeated every 2 weeks for 4 infusions"
15860304|NCT03959735|Other|High Intensity Interval Training (HIIT)|HIIT is a type of exercise involving alternating short bursts of high intensity exercise with recovery periods of rest or light exercise.
15860305|NCT03959722|Dietary Supplement|Ecologic® PERFORMANCE|"Ecologic® PERFORMANCE is a probiotic formulation consisting of different probiotic bacterial strains, namely:
~Bifidobacterium bifidum W23 Bifidobacterium lactis W51 Enterococcus faecium W54 Lactobacillus acidophilus W22 Lactobacillus brevis W63 Lactococcus lactis W58
~Except for the bacterial strains, Ecologic® PERFORMANCE contains the following other ingredients:
~maize starch and maltodextrins
~fructo-oligosaccharides (FOS) P6 and Polydextrose P4 (strain specific prebiotics)
~vegetable protein
~mineral mix (Potassium chloride, Magnesium sulphate, Manganese sulphate)"
15860306|NCT03959722|Dietary Supplement|Placebo|"The placebo contains no bacterial strains, but the following ingredients:
~maize starch and maltodextrins
~fructo-oligosaccharides (FOS) P6 and Polydextrose P4 (strain specific prebiotics)
~vegetable protein
~mineral mix (Potassium chloride, Magnesium sulphate, Manganese sulphate)"
15860307|NCT03959709|Procedure|immediate acellular dermal matrix-assisted implant-based breast reconstruction with prepectoral implant placement.|On the day of surgery, after the completion of the mastectomy, the vascularity of the mastectomy flaps will be evaluated, and debridement is performed where necessary. A temporary implant sizer is placed in the pocket to assess the position and shape of the prepectoral pocket. The pocket is adjusted where necessary. A sheet of ADM (DermAcell) is then selected. The DermAcell will be prepared as per the manufacture's instructions and fenestrated using size 11 blade. The DermACELL piece will be trimmed to the appropriate shape and sutured to the superior medial and lateral edges of the pectoralis major muscle. The inferior edge will be sutured to the fascia at the level of the inframammary fold. Two closed suction drains will be placed (one below the mastectomy skin flap, and one below DermACELL). The implant will be inserted to the pre-pectoral pocket and several anchor sutures will be used to secure the superior-medial edge of DermACELL to mastectomy flap.
15860308|NCT03959709|Procedure|Immediate acellular dermal matrix-assisted implant-based breast reconstruction with subpectoral implant placement|On the day of surgery, after the completion of the mastectomy, the vascularity of the mastectomy flaps will be evaluated, and debridement is performed where necessary. The reconstructive operative procedure will then proceeded with (1) elevation of the pectoralis major muscle with release of inferior attachments; (2) placement of implant subpectorally; (3) placement and suturing of DermACELL to constitute the inferolateral breast pocket; (4) placement of two closed suction drains (one superiorly between the pectoralis major and skin, and one inferiorly between the DermACELL and skin); (5) removal of sizer and placement of permanent to the pocket and (6) suture the inferior edge of DermACELL to the inferior edge of the pectoral major muscle. The skin will be closed and the dressing will be applied as standard protocol.
15860309|NCT03959696|Behavioral|Notification|Clinicians will be notified of their patients aged 76-85 with an upcoming, non urgent visit who are due for colorectal cancer screening.
15860310|NCT03959696|Behavioral|Training|The 2-hour continuing medical education course in shared decision making, simulated patient interaction to practice skills, and monthly calls for a year to review difficult cases with clinical and shared decision making experts.
15860311|NCT03959683|Device|Trilogy Lithotrite|The Trilogy has been FDA cleared for fragmentation of urinary tract calculi in the kidney, ureter, and bladder. Trilogy is a combined piezoelectric/pneumatic device capable of fragmenting calculi and aspirating stone debris. The novel technology in Trilogy has been demonstrated in bench testing to more quickly disintegrate stones compared to other devices.
15860312|NCT03959683|Device|The ShockPulse-SE Lithotripsy System|The ShockPulse-SE System is an electromechanical device capable of fragmenting calculi and aspirating stone debris. The novel technology in the ShockPulse-SE Lithotripsy System uses a single transducer and proprietary ShockPulse technology to generate both low-frequency mechanical impacts and high-frequency ultrasonic energy which quickly disintegrates stones.
15860313|NCT03959657|Other|No intervention performed by authors|Observational and retrospective study, no intervention performed
15860314|NCT03959631|Behavioral|Virtual Communities of practice|based on a web 2.0 platform in which there is interaction with other patients and with a multidisciplinary team of professionals. The intervention will be co-designed with a group of patients and a group of primary and specialized care professionals.
15860315|NCT03959618|Other|dietary supplements questionary|Patient Questionary Patient to be carried out at the last cure
15860318|NCT03959592|Drug|Lutein, zeaxanthin and mesozeaxanthin|The intervention will involve supplementation with the macular carotenoids (1 pill daily with a meal containing lutein, zeaxanthin, mesozeaxanthin) for six months, to determine the effects on visual performance in glaucoma patients.
15860323|NCT03959566|Drug|Midazolam oral solution|Midazolam will be administered as per probe drug use in a single dose of 2 mg at day -1 and day 14 to assess the potential of sutezolid for CYP 459 3A4 enzyme induction, as measured by its influence on the ratio of AUCs of the CYP 3A4 probe drug
15860324|NCT03959553|Drug|GV1001|Lyophilized peptide from hTERT
15860325|NCT03959553|Drug|Normal saline|0.9% normal saline
15860326|NCT03959540|Drug|Opicapone|Capsules, oral use - 50 mg Use of opicapone is only driven by the physician's decision.
15860327|NCT03959540|Drug|Levodopa (L-DOPA) + Standard care|Levodopa (immediate- or controlled-release) + Standard care. Use of Levodopa and standard of care are only driven by the physician's decision.
15860328|NCT03959527|Drug|zoliflodacin|Dose: 3g, oral administration
15860329|NCT03959527|Drug|ceftriaxone|Dose: 500mg, Intra-Muscular (IM) administration
15860330|NCT03959527|Drug|azithromycin|Dose: 1g, oral administration
15860331|NCT03959514|Biological|NovoRapid|Rapid acting prandial insulin aspart
15860332|NCT03959514|Biological|Fiasp|Fast acting prandial insulin aspart
15860333|NCT03959514|Biological|AT247|Ultra rapid acting prandial insulin aspart
15860334|NCT03959501|Drug|Dapagliflozin 10 mg|Dapagliflozin 10mg daily for 24 weeks
15860335|NCT03959501|Drug|Sitagliptin 100mg|Sitagliptin 100mg daily for 24 weeks
15860336|NCT03959488|Drug|MEDI8897|Anti-RSV monoclonal antibody with an extended half-life
15860337|NCT03959488|Drug|Palivizumab|Approved anti-RSV monoclonal antibody
15860338|NCT03959462|Device|real anodal transcranial direct current stimulation|A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used.
15860339|NCT03959462|Device|sham transcranial direct current stimulation|A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used.
15860340|NCT03959449|Behavioral|Action Observation plus motor imagery|Action observation (video) and motor imagery of running.
15860341|NCT03959449|Behavioral|Motor imagery|Motor imagery of running
15860342|NCT03959449|Behavioral|Exercise plus action Observation and motor imagery|Real exercise of running during 6 min plus action observation (video) and motor imagery of running.
15860343|NCT03959436|Drug|Carbetocin|Carbetocin as the primary uterotonic for all cesarean sections
15860344|NCT03959423|Device|AHCL insulin pump system|Advanced Hybrid Closed Loop insulin pump with associated CGM and blood glucose meter
15860345|NCT03959410|Diagnostic Test|Cervical biopsy|in office Cervical biopsy
15860346|NCT03959397|Drug|nab-paclitaxel|nab-paclitaxel monotherapy or combination therapeutic regimen
15860347|NCT03959384|Drug|Curosurf 80Mg/Ml Intratracheal Suspension|CUROSURF is a natural surfactant obtained from swine lungs containing almost exclusively phospholipids, in particular phosphatidylcholine (about 70% of the total phospholipid content) and about 1% of low molecular weight hydrophobic proteins, specific for surfactant, SP-B and SP -C. CUROSURF will be administered via endotracheopulmunary.
15860348|NCT03959384|Other|Ambient Air|Ambient air aspirated in sterile syringes
15860349|NCT03959371|Drug|Ruxolitinib|"Observational study including patients with myelofibrosis being treated with ruxolitinib in a real world setting. Patients are treated according to current indications."
15860350|NCT03959358|Drug|Lenalidomide|Lenalidomide is an antineoplastic and immunomodulatory agent that will be given as a liquid in syringes to be taken orally (by mouth).
15860351|NCT03959358|Drug|Pomalidomide|Pomalidomide is an antineoplastic and immunomodulatory agent that will be given as a liquid in syringes to be taken orally (by mouth).
15860352|NCT03959345|Drug|Combination therapy group|Adult patients with MSSA bacteraemia will be randomized to Combination therapy group: patients will receive intravenous cloxacillin 2g/4h and fosfomycin 3 g/6h for the duration of 7 days treatment. After the first week, antibiotic treatment and duration will be decided by responsible clinician following clinical practice.
15860353|NCT03959345|Drug|Standard therapy group|Adult patients with MSSA bacteraemia will be randomized to Standard therapy group: patients will receive intravenous cloxacillin 2g/4h for the duration of 7 days IV treatment. After the first week, antibiotic treatment and duration will be decided by responsible clinician following clinical practice.
15860354|NCT03959332|Drug|Baloxavir Marboxil|Participants will receive either 40 mg or 80 mg of baloxavir marboxil on Day 1 as a single oral dose.
15860355|NCT03959319|Other|Movement Pattern Training|Treatment will include 10 supervised sessions over 12 weeks and instruction in a home exercise program After randomization, participants will be scheduled with a physical therapist trained in standard procedures. Treatment will include assessment of patient goals, patient education and instruction in a home program. Patient education will focus on patient-specific tasks, identified by the participant to be symptom-producing.
15860356|NCT03959319|Other|Manual Therapy|Treatment will include 10 supervised sessions over 12 weeks and instruction in a home exercise program After randomization, participants will be scheduled with a physical therapist trained in standard procedures. Treatment will include assessment of patient goals, patient education and instruction in a home program. Patient education will focus on patient-specific tasks, identified by the participant to be symptom-producing.
15860357|NCT03959306|Dietary Supplement|Black Seed Oil|Black seed oil soft gelatin capsule
15860358|NCT03959306|Drug|Anti-Diabetics|standard anti-diabetic treatment prescribed for the patient
15860359|NCT03959293|Drug|Durvalumab|1500 mg by 1-hour IV infusion - Every 4 weeks
15860360|NCT03959293|Drug|Tremelimumab|75 mg by 1-hour IV infusion - Every 4 weeks
15860361|NCT03959293|Drug|FOLFIRI Protocol|"Irinotecan: 180 mg/m² by 2-hour IV infusion,
~Folinic acid: 400 mg/m² (or 200 mg/m² if Elvorine) by 2-hours IV infusion,
~5-FU bolus: 400 mg/m² by 10-minutes IV bolus,
~Continuous 5-FU: 2400 mg/m² by 46-hour IV infusion"
15860362|NCT03959280|Other|Tailored intervention|"The exercise program consists of 2 x 1.5-hour supervised nordic walking sessions weekly during 12 weeks and 1-hour unsupervised moderate physical activity per week from week 4.
~The diet intervention includes one face-to-face consultation with a dietician and one telephone-based contact monthly, i.e. 6 diet interventions for 12 weeks.
~Behavioural changes techniques will be included in diet and exercise interventions."
15860363|NCT03959280|Other|Control|This intervention will include tailored instruction on CPAP use and standard advices on physical activity and nutrition at CPAP initiation.
15860381|NCT03959176|Drug|Tropicamide|1 drop administered at two different times points in both eyes in both study arms
15860364|NCT03959267|Behavioral|Telephone Genetic Counseling|A genetic counselor fluent in Spanish (see letter of support) will conduct the TGC. The TGC intervention consists of two sessions. Prior to the sessions the investigators will mail participants the education materials with information to be reviewed prior to the genetic counseling session and a set of visual aids that the counselor will refer to during the session to facilitate the understanding of the information conveyed in the session.
15860365|NCT03959254|Procedure|Physiotherapy post-surgical protocol for femoroacetabular impingement|"The intervention is structured in 14 weeks. Gradually the level of demand for the exercises increases over the weeks. Isometric and concentric exercises of the affected muscle groups are combined in the first weeks, as well as mobilization exercises of the joints involved in the injury. In addition, the time of permanence in a sitting, prone or supine position is prescribed. The return to the march and activities of daily life are staggered.
~The number of series and repetitions to be performed is described in each exercise."
15860373|NCT03959228|Drug|keto-analogs|The patients that will be included in the experimental arm will have additional keto-analogs (1 pill/5 kg).
15860374|NCT03959215|Behavioral|Back in the Game|"A six-month programme of cognitive-behavioural therapy delivered by smartphone application. The intervention commences in the first week after ACL reconstruction. The smartphone app is delivered in parallel with usual rehabilitation care.
~Usual rehabilitation care: all participants will be referred to physiotherapy following ACL reconstruction. Overall treatment aims, content and progressions of rehabilitation will follow current clinical guidelines. The choice of specific therapies, exercises and the number of treatment sessions needed to achieve the treatment aims is at the clinical discretion of the treating physiotherapist."
15860375|NCT03959215|Other|Usual rehabilitation care|Following ACL reconstruction, as per routine clinical practice, all participants will be referred to physiotherapy. Overall treatment aims, content and progressions of rehabilitation will follow current clinical guidelines. The choice of specific therapies, exercises and the number of treatment sessions needed to achieve the required treatment aims is at the clinical discretion of the treating physiotherapist.
15860376|NCT03959202|Behavioral|ELDERFITNESS|In-person training with the exercise trainer ( 3 sessions for participants without cognitive impairments over 24 weeks & 4 sessions for older adults with mild cognitive impairment over 16 weeks). Self-monitoring level of physical activity (steps & minutes of moderate activity) using the smart watch. . The Google calendar and Fitbit apps will send messages and alerts to the subject's smart watch that encourage subjects to achieve subjects' daily goals. If a participant has low activity for 3 consecutive days, the research assistant will call the participant to either encourage the participant to adhere to the plan or provide a modified plan after consulting the exercise trainer. Phone consultation: Subjects will have biweekly phone consultation with the research team members to receive guidance and adjustment on activity plans.Financial incentives: when the daily activity goal is achieved for more than four days per week, a $5 reward will be given to subjects.
15860377|NCT03959202|Other|Control|General Education on physical activity for older adults and continue daily activity and healthcare routine. Participants will also receive a Go4Life Program book from the National Institute on Aging
15860378|NCT03959189|Drug|ERX-963|Active medicine
15860379|NCT03959189|Drug|Placebo|Comparator
15860380|NCT03959176|Drug|Brimonidine|2 drops administered once in the left eye in both study arms
15860382|NCT03959176|Drug|Phenylephrine Ophthalmic Product|1 drop administered at two different time points in both eyes in both study arms
15860383|NCT03959163|Diagnostic Test|Quick MRI|"A quick MRI scan takes about 15 mins or less. No IV or sedation will be necessary. The participant will be required to lie flat and still during the test. A parent will be allowed to be with the participant while they are in the scanner. The machine will produce loud intermittent sounds of banging or knocking so they will have to wear protective headphones. They can listen to music if they would like. If they are less than 1 year old, they will be swaddled and can be held during the test. If a child needs to have a parent in the scanner, it is ideal if the parent can have their head near the participant's legs and arms stretched out to hold the child's hands. If the parent needs to be by the patient's head, it can be accomplished by the parent lying head to head with the child or the parent lying on the child. Ideally they are lying head to head, or just outside of the scanner reaching in."
15860384|NCT03959150|Drug|Capecitabine|Oral fluorouracil
15860385|NCT03959137|Other|None - Common practice|None - Common practice
15860386|NCT03959124|Device|Deep brain stimulation|Brain stimulation electrodes at parameters 2.0~4.5 V；60 μs；20 Hz
15860387|NCT03959124|Drug|Best medical treatment for Alzheimer's disease|Alzheimer's disease patients take medications including Exelon (Rivastigmine Tartrate), Witgen (Memantine) for at least 3 months without plan of dosage adjustment
15860388|NCT03959111|Other|Stimulation at Location 1|Stimulation parameters will include 1) density wave adjusted to 20Hz with less than 1 ms pulse width, 2) intensity adjusted based on the tolerance of the patient (moderate tolerable stimulation without pain), and 3) treatment will be applied 1 time per day, 5 times per week for four weeks (on-site tVNS treatment plus self-administration at home).
15860389|NCT03959111|Other|Stimulation at Location 2|Stimulation parameters will include 1) density wave adjusted to 20Hz with less than 1 ms pulse width, 2) intensity adjusted based on the tolerance of the patient (moderate tolerable stimulation without pain), and 3) treatment will be applied 1 time per day, 5 times per week for four weeks (on-site tVNS treatment plus self-administration at home).
15860390|NCT03959098|Drug|Herbal medicine|Herbal medicine will be administered in water-based decoction (120ml) and dried powder (2g) form (Ostericum koreanum,Eucommia ulmoides, canthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, aposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycinemax, Atractylodes japonica) at the physician's discretion.
15860391|NCT03959098|Procedure|Chuna manual medicine|Chuna is a Korean manual therapy directed at the spine and joints that incorporates various spinal manual medicine techniques for joint mobilization involving highvelocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement. Chuna manual medicine will be administered to the pelvic, lumbar, thoracic, and cervical vertebrae at the physician's discretion.
15860392|NCT03959098|Procedure|Bee venom pharmacopuncture|Bee venom pharmacopuncture will be administered only after confirming a negative response to hypersensitivity skin test. Diluted bee venom saline:bee venom ratio, 10,000:1) filtered for allergens will usually be injected at 4-5 acupoints proximal to the dysfunctional site at the physician's discretion. Each acupuncture point will be injected to a total of 0.5-1 cc using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, hinchang medical co., Korea).
15860393|NCT03959098|Procedure|Pharmacopuncture|Pharmacopuncture consisting of select herbal ingredients will be dministered at Hyeopcheok (Huatuo Jiaji, EX B2), Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea) at the physician's discretion.
15860394|NCT03959098|Procedure|Acupuncture|Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
15860395|NCT03959098|Procedure|Electroacupuncture|Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
15860396|NCT03959098|Procedure|Cupping|Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.
15860397|NCT03959098|Procedure|Other intervention(s)|Patients will be allowed any other additional intervention(s) as deemed necessary regardless of type or dose, and patterns of use will be investigated and recorded as a pragmatic clinical study.
15860398|NCT03959085|Drug|Calaspargase Pegol-mknl|Given IV
15860399|NCT03959085|Drug|Cyclophosphamide|Given IV
15860400|NCT03959085|Drug|Cytarabine|Given IV, IT, or SC
15860401|NCT03959085|Drug|Daunorubicin Hydrochloride|Given IV
15860402|NCT03959085|Drug|Dexamethasone|Given PO or IV
15860403|NCT03959085|Drug|Doxorubicin Hydrochloride|Given IV
15860404|NCT03959085|Biological|Inotuzumab Ozogamicin|Given IV
15860405|NCT03959085|Drug|Leucovorin Calcium|Given PO or IV
15860406|NCT03959085|Drug|Mercaptopurine|Given PO
15860407|NCT03959085|Drug|Methotrexate|Given IT or IV
15860408|NCT03959085|Drug|Pegaspargase|Given IV or IM
15860409|NCT03959085|Drug|Prednisolone|Given PO or IV
15860410|NCT03959085|Other|Questionnaire Administration|Ancillary studies
15860411|NCT03959085|Radiation|Radiation Therapy|Undergo testicular radiation therapy
15860412|NCT03959085|Radiation|Radiation Therapy|Undergo cranial radiation therapy
15860413|NCT03959085|Drug|Thioguanine|Given PO
15860414|NCT03959085|Drug|Vincristine Sulfate|Given IV or IV push
15860415|NCT03959072|Device|Robotic CTO PCI|Randomized to robotic CTO PCI.
15860416|NCT03959072|Procedure|Conventional (Manual) CTO PCI|Randomized to manual CTO PCI.
15860417|NCT03959059|Device|Mixed Reality technology|combine image with real body
15860418|NCT03959046|Behavioral|GIST|The GIST intervention will train physicians in an alternative way of communicating with their patients.
15860419|NCT03959020|Procedure|Anti-reflux surgery|Anti-reflux surgery for verified GERD
15860420|NCT03959007|Other|Aesthetic therapy sessions|Only for experimental arm at 3 times during hospitalization
15860421|NCT03959007|Other|Questionnaire|Both arm at 3 times during hospitalization
15860422|NCT03958994|Other|Qualitative interviews|What are the roles of organisational factors, education and policy in shaping the experiences of staff and carers who care for people with dementia?
15860423|NCT03958981|Drug|Castor Oil|The intervention group will be given 60 mL of castor oil in 140 mL of orange juice
15876812|NCT03829319|Drug|Cisplatin|IV infusion Q3W
15860424|NCT03958981|Drug|placebo|the control group will be given a sunflower oil as a placebo with a similar texture to castor oil
15860425|NCT03958955|Drug|Delgocitinib cream|Cream for topical application.
15860426|NCT03958955|Drug|Delgocitinib cream vehicle|The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
15860427|NCT03958942|Other|Ultrasound quadratus lumborum block with bupivacaine 25%|echogenic needle will be inserted in-plane with the ultrasound beam in a posterior-to-anterior direction through the quadratus lumborum muscle until the ventral fascia of the muscle penetrated. At this point, the needle directed toward the fascial plan between the quadratus lumborum and the Psoas muscle
15860428|NCT03958942|Other|lumbar epideural block with bupivacaine 25%|lumbar epidural will be performed for patients in group II using a 16-gauge Touhy epidural needle by a median approach. The T12 - L1 or L1 - L2 interspaces will be chosen for the injection. The epidural space identified by the loss of resistance technique.
15860429|NCT03958929|Other|Educational Video|The film follows the journey of an elderly patient scheduled to undergo glaucoma surgery, beginning with a face-to-face Q&A health session with an eye doctor. After surgery, the patient talks about his post-operative eyesight and discusses the benefits of early diagnosis and glaucoma surgery for treatment with his community.
15860430|NCT03958903|Device|Amygdala recording and stimulation using Neuropace RNS|Subjects will undergo a series of different, fear-related, behavioral tasks while undergoing amygdala electrophysiology recording and stimulation using the Neuropace RNS devices.
15860431|NCT03958903|Behavioral|Behavioral tasks|Subjects perform a set of fear related behavioral tasks over 2 days, with 3 tasks each day.In addition to amygdala RNS recording and stimulation, recording of electroencephalography (EEG), electromyography (EMG), and electrodermal activity (EDA) will be performed using standard techniques to capture and quantify the fear response across all tasks.
15860432|NCT03958890|Drug|HLX10 100 mg in 10 ml Injection|3mg/kg IV（HLX10+cis-platinum+5FU）
15860433|NCT03958890|Drug|Placebos|3mg/kg IV（placebo+cis-platinum+5FU）
15860434|NCT03958877|Drug|BIIB017 (peginterferon beta-1a)|Administered as specified in the treatment arm
15860435|NCT03958877|Drug|Interferon beta type 1a|Administered as specified in the treatment arm
15860436|NCT03958864|Drug|CC-90001|CC-90001
15860437|NCT03958851|Diagnostic Test|Doppler ultrasonography of renal arteries|"Ultrasound evaluation will be performed for all patients as well as healthy individuals.in patients with lupus nephritis,the ultrasound evaluation will be performed the 24 h prior to the renal biopsy . In the maximum long-axis section images, the largest diameter and width of each kidney will be measured. The participants will be scanned in a supine or decubitus position to achieve an ultrasound beam as close to parallel to the blood flow direction in the intrarenal artery as possible. RRI is measured as :
~RRI = (peak systolic velocity - end diastolic velocity ) / peak systolic velocity. the average of three measurements will be taken."
15860438|NCT03958851|Diagnostic Test|Renal biopsy|Renal biopsy is a medical procedure in which a small piece of kidney is removed from the body for examination, usually under a microscope. Microscopic examination of the tissue can provide information needed to diagnose, monitor or treat problems of the kidney.Renal biopsy will be taken according American college of Romatology guidelines 2012.The renal biopsy samples were evaluated according to the Revision of the International Society of Nephrology/Renal Pathology Society classification for lupus nephritis 2017. the actvity index and chronicity index will be calculated.
15860439|NCT03958851|Diagnostic Test|kidney function tests|blood sample will be taken to measure blood urea nitrogen (BUN) and serum creatinine(S Cr). estimated glomerular filtration rate (eGFR) will be measured using CKD-EPI Equation.These investigations will be done at the beginning of the study and every month for sex months for each patient to determine degree of response to treatment .
15860440|NCT03958851|Diagnostic Test|The 24-hour urine protein test|The 24-hour urine protein test checks how much protein is being spilled into the urine.Urine samples are collected in one or more containers over a period of 24 hours. The containers are kept in a cool environment and then sent to a lab for analysis. Specialists then check the urine for protein.This investigations will be done at the beginning of the study and every month for sex months for each patient to determine degree of response to treatment .
15860441|NCT03958851|Diagnostic Test|complete blood counting (CBC)|A complete blood count is a blood panel that gives information about the cells in a patient's blood, such as the cell count for each blood cell type and the concentrations of hemoglobin.
15860442|NCT03958838|Behavioral|Peer Support Integrated with Primary Care|Peer leaders will deliver support that address the four key functions of peer support, providing 1) assistance in daily self-management, 2) linkages to clinical care and community resources, 3) social and emotional support, and 4) ongoing, flexible support over time.
15860443|NCT03958825|Procedure|laparoscopic hepatic sectionectomy|patients undergoing a laparoscopic left hepatic sectionectomy within an enhanced recovery after surgery programme
15860444|NCT03958825|Procedure|open left hepatic sectionectomy|patients undergoing open left hepatic sectionectomy within an enhanced recovery after surgery programme
15860445|NCT03958812|Diagnostic Test|Circulating tumor cells, Volatile organic compounds|Alveolar exhaled breath samples and peripheral venous blood(10ml) will be collected from each patients
15860446|NCT03958799|Biological|Investigational Tdap vaccine Formulation B|Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
15860447|NCT03958799|Biological|Investigational Tdap vaccine Formulation C|Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
15860448|NCT03958799|Biological|Investigational Tdap vaccine Formulation A|Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
15860449|NCT03958799|Biological|Investigational Tdap vaccine Formulation D|Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
15860450|NCT03958799|Biological|Licensed Tdap vaccine|Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
15860451|NCT03958786|Other|Simplified Geriatric Evaluation|"Questionnaires
~Self assessment questionnaires
~Mobility and balance tests"
15860452|NCT03958786|Other|Sampling|- Blood samples : 35 ml will be collected at baseline, after signature of written informed consent, 7 ml at M12
15860453|NCT03958773|Device|Cardiovalve transfemoral Mitral valve system|Cardiovalve System, comprised of: 1) Cardiovalve Implant; 2) Cardiovalve Delivery System (DS); 3) Cardiovalve Accessories.
15876813|NCT03829319|Drug|Pemetrexed|IV infusion Q3W
15860454|NCT03958747|Diagnostic Test|Ultrasound - Serial and Tibial Nerve|Participants will undergo a serial and tibial nerve ultrasound
15860455|NCT03958747|Procedure|Skin Biopsy|Two skin biopsies will be obtained as 4.0 mm punch biopsies at distal end of leg in sural nerve territory (10 cm above lateral malleolus) and from the thigh
15860456|NCT03958747|Other|Abbreviated Neurologic Exam|Exam to include strength assessment of the tibialis anterior and gastrocnemius and deep tendon reflex exam of the Achilles on the limb to be examined by nerve conduction velocity and ultrasound.
15860457|NCT03958747|Other|Blood draw|12 ml blood sample will be taken
15860458|NCT03958747|Diagnostic Test|Nerve Conduction Study|Sural and tibial nerve assessments
15860459|NCT03958747|Other|QLQ-CIPN20 Questionnaire Administration|Self-reported neuropathy scoring questionnaire completed same day as blood draw.
15860460|NCT03958734|Other|High-fat meal|Participants will be given a serving of Marie Callendar's Chocolate Satin Pie to eat over a period of 20 minutes
15860461|NCT03958721|Drug|Capecitabine|1,000 mg/m2 twice daily taken by mouth every other week
15860462|NCT03958721|Radiation|Radiotherapy|Once daily (Monday through Friday) for six weeks
15860463|NCT03958708|Drug|Rifaximin 550 MG|Rifaximin 550 MG, TWICE A DAY, FOR 7 DAYS
15860464|NCT03958695|Device|Tunable-tension transobturator tape, Urosling-T (Lintex, LLC)|A transobturator mid-urethral sling with the possibility of non-invasive tuning of its tension in the early postoperative period
15860465|NCT03958695|Device|Transobturator mid-urethral tape, Urosling (Lintex, LLC)|A transobturator tension-free mid-urethral sling
15860466|NCT03958682|Device|AR smart wearing equipment combined with 4G + satellite information transmission system|"We are going to add a pair of wearable smart glasses with AR function to the original flight helmet .During the rescue, the doctor is asked to wear the special helmet , through the device's camera system and headset, we can obtain graphics and sound of the helicopter cabin .At the same time, it also receives the historical data of patients and real-time diagnosis as well as rescue guidance from the ground medical institutions.
~It can not only transmit the patient's information in the cabin to the ground medical institutions in real time, but also transmit the rescue plan of the ground medical experts to the rescue helicopter in real time to ensure the safety of patients in transit ,which will save the time for medical staff to hand over after landing and reduce errors."
15860467|NCT03958656|Drug|Cyclophosphamide|300 mg/m^2 intravenous (IV) over 30 minutes on days -5, -4, and -3
15860468|NCT03958656|Drug|Fludarabine|30 mg/m^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3
15860469|NCT03958656|Drug|Rimiducid|0.4 mg/kg of Rimiducid intravenous (IV) over 2 hours. (A maximum of 2 doses separated by at least 48 hours) Note: Rimiducid may be administered as needed based on the patient condition at the discretion of the Principal Investigator.
15860470|NCT03958656|Biological|Anti-Signaling lymphocytic activation molecule F7 (SLAMF7) chimeric antigen receptor (CAR) T cells|0.3x10^6- 12.0x10^6 CAR+ T cells per kg of recipient bodyweight one-time dose on day 0
15860473|NCT03958617|Device|Bilateral Deep brain stimulation of the thalamus, Medtronic Device|
15860474|NCT03958604|Procedure|Neurostimulation|Spinal cord stimulation with burst modality for discogenic low back pain
15860475|NCT03958591|Drug|CSII and thereafter combination therapy with wearable devices|Short-term continuous subcutaneous insulin infusion and thereafter the combination therapy of basal insulin, metformin and vildagliptin; Wearable devices and smart apps will be used to manage and follow-up patients.
15860476|NCT03958591|Drug|CSII and thereafter combination therapy|Short-term continuous subcutaneous insulin infusion and thereafter the combination therapy of basal insulin, metformin and vildagliptin; Traditional ways such as telephone contact will be used to follow-up patients.
15860477|NCT03958591|Drug|Traditionally upgrading therapy|Patients will be applied the combination therapy of basal insulin, metformin and vildagliptin for the entire 12 weeks. Traditional ways will be used to follow-up patients.
15860478|NCT03958565|Biological|Tyrosine Kinase Inhibitor|Targeted therapy given as standard of care.
15860479|NCT03958565|Drug|Zoledronic Acid 4 MG/100 ML Intravenous Solution [ZOMETA]|Given Q4 weeks as standard of care
15860480|NCT03958565|Drug|Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]|Given Q12 weeks for bone disease as standard of care
15860481|NCT03958552|Other|Palliative Care Consultation|Trained provider will discuss illness trajectories, establish and communicate patient-directed goals that guide health care decisions, identify and treat illness-related symptoms, and identify psycho-spiritual needs and approaches to mitigate suffering.
15860482|NCT03958539|Device|3D printed insoles for normal footware|"Imprints are low-cost, bespoke, 3D-printed orthotics designed to prevent diabetic foot ulceration by redistributing and lowering peak foot pressures. This is achieved by using different density zones designed specifically for the patient. The patient's foot shape and pressure zone are capture by a 3D imaging system. Once scanned the software automatically identifies the peak pressure zones, matches these with the correct material and stiffness (densities), fits the insole arch to the patient and generates the insole.
~The imprints insole is divided into four pressure zones: heel, midfoot, metatarsal head region and toes. These zones are printed with different stiffness to account for the difference in loading between them. The design of the pressure zones is automatically matched to the shape of each individual foot with the help of the 3D scan."
15860483|NCT03958526|Device|active tDCS|Patients in active group will receive 10 sessions of anodal tDCS delivered over primary motor cortex (M1) contralateral to the most painful side with a constant current of 2 miliAmpers for 20 minutes.
15860484|NCT03958526|Device|sham tDCS|Same protocol (electrode montage,session duration) will be used for sham stimulation. But the device won't be active for full 20 minutes.
15860485|NCT03958513|Drug|Bupivacaine|1.5 ml 0.25% bupivacaine for 1 inch incision will be given before closure of ports in patients undergoing laparoscopic cholecystectomy
15860486|NCT03958513|Drug|0.9% normal saline|1.5 ml 0.9% NACl for 1 inch incision will be given before closure of ports in patients undergoing laparoscopic cholecystectomy
15860487|NCT03958500|Procedure|Indocyanine green fluorescent angiography intraluminally and intraperitoneally|The use of indocyanine green fluorescent angiography to check bowel and anastomosis viability in standard low anterior rectal anastomosis
15876814|NCT03829319|Drug|Lenvatinib|Oral capsule once daily
15860488|NCT03958487|Behavioral|Video feedback, Feedback online|The treatment phase have 3 timepoints, 1 the patient is asked to perform an ADL alone, 2. Video feedback is administrated. This requires the participant to watch its own videotaped performance with the therapist while the therapist encourage the participant to identify errors, areas of strength, and to suggest strategies to solve errors in future sessions. 3. feedback online will be provided by the therapist on participant performance. The therapist will wait for the patient to detect and correct their error spontaneously. If the patient does not detect it, the therapist provides unspecified/specific help. This strategy is based on previous work (Schmidt, et al 2013, Ownstorth et al. 2010). The novelty of our procedure is the inclusion of distracting and conflicting/problem solving situations to be inhibited, detected and solved. Feedback will focus on these situations. The level of monitoring requirements will be adjusted to participants performance using a changing criterion design.
15860489|NCT03958474|Drug|Oxycodone|Participants receive oxycodone or placebo.
15860490|NCT03958474|Drug|Remifentanil|Participants with a history of IV opioid use can opt to complete a session in which they receive remifentanil.
15860491|NCT03958461|Procedure|Anti-infective treatment of periodontal pockets|Removing calculi from teeths' periodontal pockets
15860492|NCT03958448|Procedure|Placement of extra short implants|placement of an extra short implant in the posterior edentulous ridge
15860493|NCT03958448|Procedure|maxillary sinus lift, maxillary sinus elevation, maxillary sinus augmentation|
15860494|NCT03958448|Procedure|placement of standard implant|placement of standard implant in the posterior edentulous ridge after maxillary sinus augmentation
15860495|NCT03958422|Drug|cardiomyopeptidin|The main component of cardiomyopeptidin is the peptide active substance extracted from the ventricular myocytes of healthy young pigs.
15860496|NCT03958409|Diagnostic Test|measurements to evaluate metabolic bone disease|The participants will be evaluated for a) Mineral metabolism: blood calcium, phosphorus, PTH, 25(OH) vitamin D; b) Bone turnover markers: bone-specific alkaline phosphatase, cross-linked C-telopeptide of type I collagen (CTx), and N-terminal propeptide of type I collagen (PINP); c) Bone Mineral Density using a Dual energy x-ray absorptiometry which is the standard method by which bone mass is measured clinically. The bone mass at the lumbar spine, wrist, hip and total body bone mass at 3, and 18 months.
15860497|NCT03958409|Diagnostic Test|standard care|Blood tests (Ca, Phos, PTH- mineral lab, 25OHVitD);Pregnancy Test (if applicable); dual energy X-ray absorptiometry (DXA); Bone Biopsy only if clinically indicated; treatment as clinically indicated.
15860498|NCT03958396|Drug|Remifentanil Infusion|15 minute remifentanil Infusion of either 0.05, 0.1, 0.15 or 0.2 mcg/kg/min
15860499|NCT03958383|Biological|hu14.18-IL2|A recombinant fusion protein linking the monoclonal antibody (mAb) hu14.18 with interleukin-2 (IL2), administered IT
15860500|NCT03958383|Radiation|Radiation Therapy|Palliative radiation therapy
15860501|NCT03958383|Biological|Nivolumab|Human programmed death receptor (PD-1) blocking antibody, given IV
15860502|NCT03958383|Biological|Ipilimumab|Monoclinal antibody that targets cytoxic T-lymphocyte-associated protein 4 (CTLA-4), given IV
15860503|NCT03958370|Other|Fitbit|Fitbit use during physical therapy session
15860504|NCT03958357|Device|Advanced Gynecological Applicator configuration|The Advanced Gynecological Applicator Venezia configuration is a gynaecological applicator for intracavitary and interstitial brachytherapy. The applicator consists of tubes, caps and templates to place needles, which can be combined to reach a wide range of target areas. The tubes and possibly used needles, guide the radioactive source of the afterloader to the target volume. Dose optimization and dose fractionation is performed with the goal of adapting the dose to the target volume without exceeding the dose volume constraints for the surrounding normal tissues according to the standard cervical cancer treatment of the centre.
15860505|NCT03958344|Drug|Prednisolone|Oral Tablet
15860506|NCT03958344|Drug|Triamcinolone + Betamethason|A compound long acting and short acting injectable steroid
15860507|NCT03958331|Behavioral|Automated Digital Reminders|Reminders from electronic monitors via texts or alarms/lights
15860508|NCT03958331|Behavioral|Individualized Adherence Feedback Report|Feedback report on individual adherence behaviors
15860509|NCT03958331|Behavioral|Individual Adherence Feedback Report with Social Norms|Feedback report on individual adherence behaviors compared to other adolescents with epilepsy
15860510|NCT03958318|Other|Exercise plus nutritional suplementation|For 6 months, all participants in the exercise plus nutritional supplementation group will be performing a three-week non-consecutive exercises programme at the facility. All exercises will be undertaken in a large indoor room. The exercise routine will be based on the Otago exercise programme.
15860511|NCT03958318|Other|Exercise|For 6 months, all participants in the exercise group will be performing a three-week non-consecutive exercises programme at the facility. All exercises will be undertaken in a large indoor room. The exercise routine will be based on the Otago exercise programme.
15860512|NCT03958305|Procedure|RADICAL HYSTERECTOMY|Radical hysterectomy is an operation done to treat some cancers of the cervix. The surgeon takes out the uterus and the ligaments (tissue fibers) that hold it in place. The cervix and an inch or 2 of the vagina around the cervix are also removed.
15860513|NCT03958292|Device|IODIM|Eye drops containing polyvinylpyrrolidone-Iodine (PVP-Iodine), hyaluronic acid and triglycerides
15860514|NCT03958279|Diagnostic Test|Ultrasound measurement of residual volume in the urinary bladder|Aim of this study is to asses post voiding residual volume by ultrasound scan 3th day after delivery with consecutive scan after 6 weeks, and determination of data dispersion among the population of primiparas.
15860515|NCT03958279|Diagnostic Test|Questionnaire|Simple questionaire concerning voiding problems, infectious complications, medicaments and breastfeeding during puerperium period (6weeks)
15860516|NCT03958266|Device|MyIBD Care|Novel mobile phone application
15860517|NCT03958253|Other|Toolbox for Lung Cancer Screening|"-Toolbox of evidence-based elements that a primary care or referral site could implement to address known barriers to screening and referral, as well as required elements for screening. These elements will be designed to be adaptable to the unique needs and screening processes of the participating practices.
~Patient education materials
~Primary care practice educational materials
~Pack-years/eligibility calculator
~Local referral process guide
~Smoking cessation materials and support
~Shared decision-making guide
~LDCT best practice guidelines"
15860611|NCT03957473|Device|Indigo Aspiration System|Indigo Aspiration System with CAT RX Aspiration Catheter and optional Indigo Separator 4
15860518|NCT03958240|Other|Blood samples, tumor biopsy specimens and ascites samples will be collected.|"Blood samples, tumor biopsy specimens and ascites samples will be collected at different time points (if feasible, according to the samples taken in the standard practice):
~at Baseline,
~every 6 months (± 1 month) during the planned visits in the center for clinical standard care and for a maximum follow-up period of 5 years from baseline.
~If tumor biopsy and/or ascites sampling are performed during the standard care, a sample will be collected for the study at baseline and at the time of progression."
15860519|NCT03958227|Other|Manuel Therapy plus Exercise Intervention|Shoulder mobilization techniques include glenohumeral traction, anterior, posterior and inferior glide. We will also use anterior, posterior and inferior joint stretching exercises and scapular mobilization. Exercise interventions include range of motion exercises, stretching exercises, strengthening exercises, and pendulum exercises.
15860520|NCT03958227|Other|Exercise Intervention|Exercise interventions include range of motion exercises, stretching exercises, strengthening exercises, and pendulum exercises.
15860521|NCT03958214|Behavioral|Recipe 4 Success|Home visitors teach parents about children's self-regulation skills and healthy eating habits. The home visitors then teach parents how to sensitively scaffold the development of their toddlers' self-regulation skills in the context of cooking and snack preparation lessons. Prior research shows that self-regulation skills in early childhood predict long-term health indicators, such as BMI. Prior research also shows that children who are involved in the preparation of healthier foods are more likely to eat them.
15860522|NCT03958214|Behavioral|Usual practice Early Head Start|Home visitors will continue to deliver usual practice Early Head Start home visits that follow a standard curriculum and are tailored on an ongoing basis to meet individual family needs.
15860523|NCT03958201|Combination Product|Protocol for Management of Muscle Relaxation With Rocuronium Using Objective Monitoring and Reversal With Neostigmine or Sugammadex|The protocol includes specified appropriate rocuronium dosing and a valid pre-reversal assessment of the adductor pollicis response guides optimal neostigmine vs. sugammadex reversal.
15860524|NCT03958188|Other|Standardized computerized tomography (CT) reading grid for preoperative planning|"Using the standardized reading grid, the following data will be collected:
~Small Intestine: tumor, parietal thickening, occlusive syndrome, proximity of the tumor with the ileocecal valve.
~Mesenteric mass: presence, size, shape, contours, calcifications, enhancement, superior mesenteric arterial invasion and number of non-invaded arterial arteries.
~Mesentery: moniliform venous dilatations, combed appearance.
~Duodenal invasion.
~Lymphadenopathies (Mesenteric, Right mesocolic and Retropancreatic): presence, size, shape, enhancement
~The anonymized CT exam will be reviewed by an expert radiologist and a radiology resident from imaging department of the Hospital."
15860525|NCT03958175|Other|Alouette test (reading test)|The alouette test was assessed at a fixed distance of 40 centimeters on a fixed surface to avoid errors related to hand tremors.
15860526|NCT03958162|Diagnostic Test|lung biopsy|transbronchial lung cryobiopsy
15860527|NCT03958149|Device|spinal collar|cervical collar to immobilise the cervical spine
15860528|NCT03958136|Procedure|Metastasis biopsy|Metastasis biopsy will be performed for multi-omic analysis
15860529|NCT03958136|Biological|Biomarkers blood, urine and microbiota samples|Biomarkers blood, urine and microbiota samples for multi-omic analysis
15860530|NCT03958136|Behavioral|Patient Reported Outcome (PRO)|Patient Reported Outcome (PRO) will be collected throughout the study duration to assess quality of life, anxiety, depression distress, physical activity and food habits.
15860531|NCT03958123|Drug|100 μg cebranopadol|Encapsulated 100 μg cebranopadol tablet.
15860532|NCT03958123|Drug|200 μg cebranopadol|Encapsulated 200 μg cebranopadol tablet.
15860533|NCT03958123|Drug|400 μg cebranopadol|Encapsulated 400 μg cebranopadol tablet.
15860534|NCT03958123|Drug|Placebo to cebranopadol encapsulated tablets|Matching placebo to cebranopadol encapsulated tablet.
15860535|NCT03958123|Drug|400 mg Moxifloxacin|Encapsulated 400 mg moxifloxacin tablet.
15860536|NCT03958123|Drug|Placebo to moxifloxacin encapsulated tablets|Matching placebo to moxifloxacin (400 mg) encapsulated tablet.
15860537|NCT03958110|Diagnostic Test|OCT A|OCT (Optical Coherence Tomography) and Retinophotography made at the beginning and end of the Rugby season.
15860538|NCT03958097|Combination Product|NK cell and PD-1 antibody|Each patient enrolled the study will received both NK cell and PD-1 antibody.
15860539|NCT03958084|Diagnostic Test|Straight Leg Raise|The assessment of the flexibility of the hamstring will be realized through the test of straight leg raise (SLR). The SLR is a passive test performed unilaterally.
15860540|NCT03958071|Drug|Nintedanib|Nintedanib initiators
15860541|NCT03958071|Drug|Pirfenidone|Pirfenidone initiators
15860542|NCT03958071|Other|Untreated Cohort|Untreated
15860543|NCT03958058|Drug|Anti-borrelial antibiotic therapy|Beside symptomatic therapy, patients received oral doxycycline 100 mg (Doxy®) twice daily or ceftriaxone 2 g (Lendacin®) once daily for 14 days. Antibiotic therapy was left to the discretion of treating physicians. Patients reported the presence of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia.
15860544|NCT03958058|Other|No antibiotic.|Patients who received symptomatic therapy (paracetamol, Lekadol®, granisetron, Kytril®, metamizol, Analgin®, parenteral hydration with saline). Patients reported the presence of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia.
15860545|NCT03958045|Combination Product|Rucaparib and Nivolumab|Rucaparib (600mg BID) and Nivolumab (480mg IV q4 wk)
15860546|NCT03958032|Other|No intervention|No intervention is planned for the participants for the treatment of gastric cancer. Treatment decision will be in line with clinical practice guidelines. Surgical team will be blind to the participant's sarcopenia status.
15860547|NCT03958019|Other|RESTORE II Program|Detailed in arm description
15860548|NCT03958006|Device|Cochlear implant|Tumor resection with cochlear implant
15860549|NCT03957993|Other|Occupational Therapy via Telehealth|The caregiver will be with the participant in their home environment receiving occupational therapy via Telehealth (video-calling) with the occupational therapist.
15860550|NCT03957993|Other|Standard of Care Occupational Therapy|The caregiver and participant will be in the clinic receiving occupational therapy in-person with the occupational therapist.
15860612|NCT03957460|Other|SpHb monitoring|Subjects receive the continuous and noninvasive hemoglobin monitoring (SpHb monitoring).
15878253|NCT03818256|Drug|Miricorilant|Miricorilant 600mg
15860551|NCT03957980|Other|Occupational therapy|Child/caregiver dyads in this group will participate in telehealth-based intervention sessions in their home environment. Each child/caregiver dyad will participate in up to 9 interventions sessions. All intervention sessions will last 30-60 minutes. The intervention sessions will focus on task analysis, caregiver coaching, parent education and recommendations for task and home/environmental modifications to promote the child's functional vision.
15860552|NCT03957967|Other|video taken|Patients enrolled will be operated in our institution. Facial expression will be collected before and after surgery, and pain intensity will be collected at the same time. Facial expression will be analyzed using Facial Action Coding System (FACS) .This step will seek to confirm that the subset of Action Units (AUs) defined in previous studies is correlated with the presence and intensity of an acute pain or to identify a different original subset of facial AUs better correlated to pain intensity. . The developed algorithm (or model) here should be able to correlate facial AUs to pain intensity reported by the patients on the numerical rating scale. The developed model at this stage will be then validated on an additional sample of patients.
15860553|NCT03957954|Biological|cLSC|Transplantation of cLSC
15860554|NCT03957954|Device|Scleral contact lens (SCL)|Scleral contact lens device (SCL) will be used to stabilize and improve ocular surface.
15860555|NCT03957941|Behavioral|FamilyLink Pumping|Viewing baby via FamilyLink while pumping
15860556|NCT03957941|Behavioral|Standard Pumping|Not viewing baby via FamilyLink while pumping
15860557|NCT03957928|Other|Low fat cookie|to determine the effects of low fat cookie consumption on satiety and metabolic parameters in overweight/obese adults
15860558|NCT03957928|Other|Mango fruit|to determine the effects of fresh mango pulp consumption on satiety and metabolic parameters in overweight/obese adults
15860559|NCT03957915|Drug|INA03 administration|INA03 will be administered IV on Day 1, Day 14 of 28-day cycles. The administration of INA03 will begin at 0.02 mg/kg. Study Part I is a titration study to determine the dose for the first INA03 infusion. Patients will be enrolled in sequential cohorts of 2 patients to receive ascending starting doses of INA03, starting from the lowest starting dose (0.02 mg/kg), and followed by subsequent administrations of INA03 (D14 and beyond) at a fixed dose of 0.1 mg/kg. The starting dose will be increased every cohort of 2 patients until evidence of absence of marrow residual erythroblasts by D14 myelogram. This dose is referred to as the MEID and will be selected as the D1 dose for the study Part 2. Patient accumulation in Part I of the study will continue until no evidence of non-hematological DLT within 28 days post dosing
15860560|NCT03957902|Drug|acetylsalicylic acid|Different dosage effect over platelet COX enzymes, non- neoplastic and neoplastic colonic tissues used as biomarkers of clinical efficacy in CRC chemoprevention
15860561|NCT03957889|Other|Educational simulation|
15860562|NCT03957876|Drug|CPX-351|CPX-351 is a liposomal formulation of a fixed combination of the antineoplastic drugs cytarabine and daunorubicin.
15860563|NCT03957863|Biological|Plasma collection for EPO assay|Plasma collection for EPO assay
15860564|NCT03957850|Behavioral|Cognitive Reappraisal Training|The training procedure is adapted from a study by Denny & Ochsner (2014). Before the task, participants are instructed that they will be presented pictures and that these pictures will be preceded by a condition specific cue signaling the appropriate strategy during picture viewing. Participants are instructed to indicate their affective response to the image on a rating scale. The task involves 4 conditions: 1) Negative-decrease: participants are asked to view negative pictures and to decrease their affective response by reappraising the negative event. 2) Negative-attend/ 3) Neutral-attend/ 4) Positive-attend: participants are asked to view pictures and to respond naturally to them without trying to alter their affective response. The training task will be repeated over 4 training sessions.
15860565|NCT03957850|Behavioral|Control Training|The task in the control group is implemented to account for unspecific effects and is as similar as possible to the CR task except that it involves no negative-decrease (i.e., no reappraisal) condition. Instead, the control task only involves the three attend conditions (negative- attend, neutral-attend, positive-attend).
15860566|NCT03957837|Diagnostic Test|Optical nerve sheath diameter ultrasound measurement|"In cases: ultrasound measurement of the diameter of the optical nerve sheath at (T1) baseline before the induction of general anesthesia (5 min after the beginning of mechanical ventilation in supine position); (T2) after 10 min from 25 degrees head down positioning and with pneumoperitoneum insufflation; (T3) after 60 min from T2, in head down position; (T4) after 10 min from tracheal tube removal, in supine position.
~In healthy controls: ultrasound measurement of the diameter of the optical nerve sheath at (T1) baseline in supine position; (T2) after 10 min from 25 degrees head down positioning; (T3) after 60 min from T2, in a head down position; (T4) after 10 min from positioning supine"
15860567|NCT03957824|Diagnostic Test|PREVENTION-ACHD risk score|The predicted risk of sudden cardiac death according to a risk score will be tested by the actual rate of sudden cardiac death
15860568|NCT03957811|Other|Whole body Vibration exercise|Intervention will consist of sessions of exercise on a whole body vibration platform, three times a week for 12 weeks.
15860569|NCT03957798|Behavioral|RecoveryWarrior 2.0|"RecoveryWarrior 2.0 was developed for use with Microsoft Kinect running on a Windows personal computer. All games made use of whole-body motion detection and the same voice-recognition feature. Body motions included a variety of arm, leg, and whole-body movements to physically enact the motions of destroying or evading images of drugs and drug paraphernalia. Voice features consisted of recognition of the refusal phrase I'm Clean Players could say or shout I'm Clean in order to gain additional strength for their game play avatar. All game art was created in a hyperrealistic, idealized, heroic style."
15860570|NCT03957785|Device|AlterG Treatment|All participants practiced one session a day of AlterG or TGT (for 40min), six days a week, for four weeks (for a total amount of 24 sessions). All patients were trained using BWS, FAC-tailored physiotherapist assistance, and treadmill speed (S) to allow the participant to walk with the intermittent support of one physiotherapist to help with balance and coordination (FAC 2), with the visual supervision of one physiotherapist (FAC 3), or independently without using the handrails (FAC 4). BWS, physiotherapist assistance, and S were checked and adapted to subjects' progresses across the AlterG sessions. A qualitative (using FAC) and quantitative (spatio-temporal parameters and dynamic electromyography) gait assessment before and after the end of the monthly LBPP gait training was carried out.
15860571|NCT03957772|Procedure|Extrafascial injection|Extrafascial injection of local anaesthetic under ultrasound guidance
15860572|NCT03957772|Procedure|Intrafascial injection|Intrafascial injection of local anaesthetic under ultrasound guidance
15860573|NCT03957759|Diagnostic Test|Structured self-monitoring during an altitude ascent and stay at high altitude|Structured self-monitoring by a symptom checklist in combination with a pulse oximeter worn at the wrist in lowlanders with COPD ascending from low altitude (760m) to high altitude (3100m).
15860574|NCT03957746|Other|Resistance training|3, 6 or 9 sets of biceps curl with elastic bands at 20 repetition-maximum (RM)
15860575|NCT03957733|Drug|Chemotherapy|Long course CRT is followed by 4 cycles of combination chemotherapy of modified FOLFOX6 or 3 cycles of XELOX (capecitabine and oxaliplatin) and then surgery
15860576|NCT03957720|Drug|DMPS|Dosage Form: DMPS: 500-1000mg per day,DMPS Frequency:BID,DMPS Duration: 6 days;
15860577|NCT03957720|Drug|Penicillamine|Dosage Form: Penicillamine: 250-1500mg per day, Frequency:TID,Duration: 5 years;
15860578|NCT03957720|Drug|DMSA|Dosage Form: DMSA: 750-1000mg per day,DMSA Frequency:BID,DMSA Duration: 5 years; Dosage Form: DMSA: 35mg/kg per day,DMSA Frequency:BID,DMSA Duration: 5 years;
15860579|NCT03957720|Drug|Zinc gluconate|Dosage Form: Zinc gluconate: 140mg per time,Zinc Frequency:BID,Zinc Duration: 5 years; Dosage Form: Zinc gluconate: 140mg per time,Zinc Frequency:TID,Zinc Duration: 5 years; Dosage Form: Zinc gluconate: 210mg per time,Zinc Frequency:TID,Zinc Duration: 5 years;
15860580|NCT03957707|Procedure|stereotactic surgery plus thrombolysis|stereotactic puncture and aspiration to evacuate basal ganglion hematoma with or without thrombolytic agent
15860581|NCT03957694|Drug|Romiplostim|Romiplostim SC. Initial dose is 10 ug/kg/. Maximum dose is 20 ug/kg. Original duration is 6 months from first administration but if investigator decide that the patient is needed more treatment, they move to extention period and take treatment up to 1 year.
15860582|NCT03957681|Drug|KHK4827|210 mg Q2W, SC
15860583|NCT03957681|Drug|Placebo|Q2W, SC
15860584|NCT03957668|Drug|PEG 3350|PEG 3350 17 g once daily for 14 days
15860585|NCT03957668|Drug|Lactulose|Lactulose 10 g once daily for 14 days
15860586|NCT03957655|Biological|SHED group|1x10E6 MSCs/kg body weight will be administered via peripheral vein for 4 times at week 0,4,8,12
15860587|NCT03957629|Drug|Tenofovir Disoproxil Fumarate|Oral medication of Tenofovir Disoproxil Fumarate 300mg once per day.
15860588|NCT03957629|Drug|PEG-Interferon alfa 2a|Subcutaneous injection of Peginterferon Alfa-2a 180 μg once per week.
15860589|NCT03957603|Dietary Supplement|Enteral Nutrition Suspension (TFP-DM)|Individualized dietary and lifestyle intervention combined with the recommendation of Enteral Nutrition Suspension (TPF-DM, Diason 0.75 kcal/ml)
15860590|NCT03957603|Behavioral|Medical Nutrition Therpay|Individualized dietary and lifestyle intervention
15860591|NCT03957590|Drug|Tislelizumab|Administrated at dose of 200 mg intravenously (IV)
15860592|NCT03957590|Drug|Placebo|Placebo to match tislelizumab
15860593|NCT03957590|Drug|Paclitaxel|Administered as 135 mg/m² IV injection
15860594|NCT03957590|Drug|Cisplatin|Administered as 25 mg/m² IV injection
15860595|NCT03957590|Radiation|Radiotherapy|Administered at a total dose of 50.4 Gy in 28 fractions
15860596|NCT03957577|Other|Prospective observational cohort study|Prospective observational cohort study
15860597|NCT03957564|Drug|Neoadjuvant chemotherapy with PSOX regimen.|"Resectable gastric or gastro-oesophageal junction cancer patients receiving neoadjuvant chemotherapy with PSOX（Paclitaxel+Oxaliplatin+S1）regimen.
~The details are as follows:
~Paclitaxel 135mg/m2 d1, Oxaliplatin 85mg/m2 d1, S1 40-60mg/m2 twice daily, d1-14 , 21 days is one cycle."
15860598|NCT03957564|Other|Detect the imaging data and levels of CTC, ctDNA, cfDNA, CEA, CA19-9, CA72-4 in plasma.|Detect the imaging data and levels of CTC, ctDNA, cfDNA, CEA, CA19-9, CA72-4 in 3 time points：Before neoadjuvant chemotherapy, After 2-3 cycles of neoadjuvant chemotherapy, 10 days after operation.
15860599|NCT03957564|Other|Detect the tumor related DNA in pathological tissues after operation.|Detect the tumor related DNA in pathological tissues after operation.
15860600|NCT03957564|Other|Follow-up of DFS and OS in patients with gastric cancer after operation.|Follow-up of DFS and OS in patients with locally advanced or resectable gastric or gastro-oesophageal Junction cancer.
15860601|NCT03957551|Drug|Cabozantinib|"Cabozantinib is an oral small molecule potent inhibitor of pro-invasive receptor tyrosine kinases (RTKs).
~Cabozantinib will be administered in the tablet form, at three dose levels: 40, 20 and 60 mg per day, in combination with pembrolizumab. The drug is taken continuously for 21 days or 3 weeks. This period of time is defined as one treatment cycle."
15860602|NCT03957551|Drug|Pembrolizumab|Pembrolizumab is a humanized antibody which will be administered as an intravenous infusion at a fixed dose of 200 mg once every 3 weeks in combination with cabozantinib.
15860603|NCT03957538|Behavioral|Virtual reality angiogram experience video|The VR video is watched via the VR headset, and describes the pre- procedural and procedural experience. Concurrent audio will be provided through earplugs to compete the patients' immersive experience. The video was written and directed by the team, and care has been taken to ensure that the same procedural information is contained within both the British Heart Foundation cardiac catheterisation video and of VR immersive video. Filming was performed within the cardiac catheterisation labs at our tertiary centre using the professional services of Orchard Media (Cardiff, UK). The investigators utilized real physicians and nurses to re-enact a typical day for a mock patient undergoing an uncomplicated procedure. There is also a short explanation of the procedure and animations explaining technical aspects of the procedure contained within the VR video.
15860604|NCT03957525|Other|Pre-Operative Preparatory Virtual Reality Program|The Influence of a Pre-Operative Preparatory Virtual Reality Program on the Self-Assessed Anxiety of Children Undergoing Elective Surgery
15860605|NCT03957512|Procedure|Heart surgery|All invasive procedures
15860606|NCT03957499|Drug|Bupivacaine|Ultrasound guided fascia iliaca compartment block (FICB) will be performed using 28 ml bupivacaine 0.25% + 2 ml of normal saline (total volume 30 ml).(
15860607|NCT03957499|Drug|Dexamethasone/bupivacaine|Ultrasound guided fascia iliaca compartment block (FICB) will be performed with 28 ml bupivacaine 0.25% + 2 ml dexamethasone (8mg) (total volume 30 ml)d using
15860608|NCT03957499|Drug|Magnesium Sulfate/bupivacaine|Ultrasound guided fascia iliaca compartment block (FICB) will be performed using 28 ml bupivacaine 0.25% + 2 ml magnesium sulphate (200mg) (total volume 30 ml).
15860609|NCT03957486|Other|arterila cannulation on same arm|arterila cannulation on same arm receiving continous hemoglobin monitoring
15860610|NCT03957486|Other|arterila cannulation on different arm|arterila cannulation different arm receiving continous hemoglobin monitoring
15860613|NCT03957447|Other|thermotherapy (application of heat): This part of the trial is on hold due to the Covid19-pandemia|Heat treatment is applied for 42 days plus a safety margin of up to 14 days, if ulcer margins have not fully collapsed and/or induration has not fully subsided. Treatment terminates earlier, if a lesion is completely closed. Thermotherapy will be applied with heat packs twice daily.
15860614|NCT03957434|Other|Physiotherapy|Education, pelvic floor muscle exercises with biofeedback and home exercises.
15860615|NCT03957421|Other|aquatic exercise, land based exercise|general warm up and cool down. general exercises and treadmill training at self-selected intensity.
15860616|NCT03957408|Device|Visual Stimuli|Subjects will be presented various visual stimuli and may be asked to perform tasks. Their accommodative response will be measured.
15860617|NCT03957395|Device|Device: Precision Novi™ system Neurostimulation procedures|SCS with Device: Precision Novi™ system
15860618|NCT03957382|Device|Accero® Stent|The Accero® Stent will only be used in line with the Instructions For Use (IFU). Patients participating in this PMCF (Post- Market Clinical Follow-up) will not be exposed to any additional risk. There are no additional treatments or investigations other than done in the clinical routine.
15860619|NCT03957369|Diagnostic Test|HIV-1 plasma RNA Genotyping secuencing by Sander|After signing informed consent, we will collect whole blood for HIV genotyping in plasma HIV-1 RNA for testing of resistance-associated mutations to reverse transcriptase, protease, and integrase enzymes.
15860620|NCT03957369|Diagnostic Test|Proviral DNA genotyping sequencing|Sequencing for resistance-associated mutations will also be performed in proviral DNA to correlate with results from plasma RNA
15860621|NCT03957356|Device|HLBLS-200|The amount of HLBLS-200 applied will be determined by the investigator based on the resection area.
15860622|NCT03957343|Device|Pacing and Planning App|Participants will download and use the Pacing and Planning app through mybrainpacer.ca. The app will be used to track and monitor their daily tasks and symptoms at any time, for as long as they would like to use the app. While using the app, participants will also fill out short assessments, including the Rivermead Post-Concussion Questionnaire once a month (to monitor symptoms) and an overall symptom question once a week (to rate how they feeling in general from a lot better to a lot worse).
15860623|NCT03957330|Behavioral|Internet-delivered cognitive behaviour therapy|All clients will receive the Wellbeing Course developed at Macquarie University, Australia. The Wellbeing Course is a transdiagnostic Internet-delivered cognitive behaviour intervention targeting symptoms of depressive and anxiety disorders. It comprises 5 online lessons targeting: 1) symptom identification and the cognitive behavioural model; 2) thought monitoring and challenging; 3) de-arousal strategies and pleasant activity scheduling; 4) graduated exposure; and 5) relapse prevention. Materials are presented in a didactic (i.e., text-based with visual images) and case-enhanced learning format (i.e., educational stories demonstrate the application of skills) and include homework activities. Lessons are released gradually in a standardized order over 8 weeks. Phone calls will only be made if there is a significant clinical issue requiring therapist attention that cannot be addressed over email (e.g., sudden increase in symptoms). Therapists will spend ~15 mins. per week/per client.
15860624|NCT03957317|Other|Eye mask and ear plugs|Subjects receive one pair of eye mask and ear plugs during their stay in the surgical ICU.
15860625|NCT03957304|Drug|Dexmedetomidine|Intranasal dexmedetomidine
15860626|NCT03957291|Drug|Chlorhexidine|chlorhexidine administration prior to ophthalmic surgery (compared to Povidine iodine )
15860627|NCT03957291|Drug|Povidone-Iodine|Povidine iodine administration prior to ophthalmic surgery (compared to chlorhexidine)
15860628|NCT03957278|Device|DAISe System|The DAISe System is indicated for revascularization of patients with acute ischemic stroke for the removal of fresh thrombi from vessels in the neurovasculature.
15860629|NCT03957265|Procedure|Tapered abutment connection|Rehabilitation of completely edentulous patients with overdentures prostheses.
15860630|NCT03957252|Diagnostic Test|Blood test: ClarityDX Prostate|Extracellular Vesicle profiling on patients who are suspected to have prostate cancer and will undergo a prostate biopsy. ClarityDX Prostate Risk Score will be compared with biopsy results to assess its predictive accuracy.
15860631|NCT03957239|Other|Cranberry Beverage|The cranberry beverage will provide 50 kcals and 4.0 grams of fiber per day from whole milled cranberries, water, cranberry natural flavor and sucralose.
15860632|NCT03957239|Other|Control Beverage|The control beverage will provide 50 kcals per day and is a color, taste matched sugar sweetened beverage formulated with water, sucrose, citric acid, cranberry natural flavor, malic acid, xanthum gum, sucralose and artificial color (red 40, blue 1).
15860633|NCT03957226|Device|e-OPRA (electronic-Osseoanchored Prosthese for the Rehabilitation of Amputees)|The e-OPRA is an implant system that provides an alternative to traditional socket prostheses by establishing a direct, load-bearing link between the patient's skeleton and a prosthesis for transhumeral amputees. The anchorage element of the system is implanted directly into the bone while the electrodes that provide control signals for the prosthesis are implanted into muscle grafts on the transhumeral amputation.
15860634|NCT03957213|Device|Acute Intermittent Hypoxia|Acute intermittent hypoxia is a safe, non-invasive technique. All sessions will be monitored by research study staff trained in delivering acute intermittent hypoxia. Hypoxic intervals will be delivered with a commercially available sports performance hypoxicator. A unit capable of delivering a fraction of inspired oxygen ranging from 21%-9% will be used. Air will be delivered into a mask that will be secured comfortably over the subject's nose and mouth. Intervention sessions will occur for 10 days over a 2 week period.
15860635|NCT03957213|Behavioral|Computerized Cognitive Training|60 minutes of Double Decision cognitive training for 10 days over a 2 week period.
15860636|NCT03957187|Diagnostic Test|Ferritin, iron and iron binding capacity, high sensitive C-reactive protein (CRP) measurement|"Ferritin, iron and iron binding capacity will be measured for evaluation of ID using Cobas c-e and Elecsys.
~The relation of inflammation to iron deficiency will be evaluated by high sensitive C-reactive protein measurement."
15860637|NCT03957174|Drug|Reboxetine|Single dose used to increase central norepinepherine
15860638|NCT03957174|Drug|Rivastigmine|Single dose to increase central acetylcholine
15860639|NCT03957174|Drug|Placebo oral tablet|Single dose as control condition
15860640|NCT03957161|Other|Continuation of ACEi and/or ARBs|Patients will continue or start taking ACEi and/or ARBs
15860729|NCT03956433|Dietary Supplement|Ready-made pancakes enriched with anthocyanins (AC)|One portion of AC-enriched pancakes will be eaten each day for 4 weeks.
15860641|NCT03957148|Behavioral|Sugar-sweetened beverage reduction education for preschool children|Participants in the SSB-IMB program will receive 10 weeks of SSB related nutrition education at their child's preschool. Each week a different lesson pertaining to parental information, motivation, or behavioral skills related to SSBs will be presented via an interactive display board. Twice a week, two student educators will stand by display boards for two hours and deliver the lessons that will last 5-10 minutes with each parent. These displays will include an activity for parents to apply knowledge and skills learned during the short lesson. Educators will also provide parents with informational handouts pertaining to each lesson to reinforce concepts learned. Display board education is flexible, so that if a parent arrives while another parent is receiving education, the second educator can begin the lesson with the new parent. Multiple parents can participate in a lesson at the same time. Groups of 2-3 parents can review the lesson together, learning from each other.
15860642|NCT03957135|Procedure|Laparoscopic distal pancreatectomy|Laparoscopic resection of the diseased portion of the pancreas for treatment of pancreatic cancer
15860643|NCT03957135|Procedure|open distal pancreatectomy|Open resection of the diseased portion of the pancreas for treatment of pancreatic cancer
15860644|NCT03957122|Device|repetitive transcranial magnetic stimulation|"Stimulation of the temporoparietal junction with repetitive transcranial magnetic stimulation
~2000 pulses
~intensity of 110% resting motor threshold
~10 sessions (daily from Monday to Friday)
~positioning of coil according to EEG position CP5/CP6"
15860645|NCT03957109|Procedure|general anesthesia|
15860646|NCT03957096|Drug|SGN-CD47M|SGN-CD47M administered intravenously
15860647|NCT03957083|Drug|Oxytocin|Oxytocin administered intravenously, over 1 minute following delivery of the fetal head
15860648|NCT03957070|Device|Liver Incyte|Ultrasound elasticity imaging
15860649|NCT03957057|Drug|Iron Carboxymaltose|Intravenous iron carboxymaltose application
15860650|NCT03957057|Drug|Iron Isomaltoside|Inravenous iron isomaltoside application
15860651|NCT03957057|Drug|Ferrous sulphate|Oral ferrous sulphate application
15860652|NCT03957044|Other|The education of sensory integration with vestibular education|"Tactical, proprioceptive, visual and auditory senses were used in sensory integrity training sessions. In this group, the training program on tactile, proprioceptive, visual and auditory sensory activities was carried out for 2 weeks and 40 minutes. Sensory integrity training was performed by the physiotherapist and in the sensory room.
~At the end of the training sessions, mothers were informed about the application of sensory integrity training to daily activities.Sensory integrity therapy room added tactile, proprioceptive, visual and auditory sensory materials as well as materials for vestibular sensation. Vestibular sensory materials, skateboard, swing, hammock, bowl, ball, ball pool, slide, climbing bar, trampoline, and balance board were used."
15860653|NCT03956992|Other|Mouth gel|Stop using the mouth gel
15860654|NCT03956979|Drug|JM-010 group A|JM-010 fixed combination drug(4/0.8mg) + Placebo 2
15860655|NCT03956979|Drug|JM-010 group B|JM-010 fixed combination drug (8/0.8mg) + Placebo 1
15860656|NCT03956979|Drug|Placebos|Placebo 1 + Placebo 2
15860657|NCT03956966|Drug|TQL block with saline|"drug: saline 21 ml 0.9% normal saline administered on each side as bilateral TQL blocks Drug: fentanyl With induction of general anaesthesia, fentanyl (1 microgram.kg) will be given. Intraoperatively, fentanyl boluses (0.5 microgram.kg) will be given in case of increase in intraoperative mean arterial blood pressure or heart rate of more than 20% of baseline for longer than 5 minutes.
~Drug: Paracetamol Paracetamol infusion (15 mg.kg) will be given by intravenous infusion after induction of general anesthesia. Postoperatively, 1 g of paracetamol will be given by intravenous infusion to all cases every 8 hours.
~Drug: Ketorolac analgesia In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases Drug: Nalbuphine Nalbuphine boluses 0.1 mg. /kg will be given as rescue analgesia if VAS is more than3.
~Device: ultrasound-guided nerve block Transmuscular quadratus lumborum block, ultrasound-guided"
15860658|NCT03956966|Drug|TQL block with Bupivacaine|"Drug: saline
~1mL 0.9% normal saline administered on each side as bilateral TQL blocks drug: Bupivacaine 20 ml Bupivacaine hydrochloride 0.25% administered on each side as bilateral TQL blocks Drug: fentanyl With induction of general anaesthesia, fentanyl (1 microgram.kg) will be given. Intraoperatively, fentanyl boluses (0.5 microgram.kg) will be given in case of increase in intraoperative mean arterial blood pressure or heart rate of more than 20% of baseline for longer than 5 minutes.
~Drug: Paracetamol 15 mg.kg will be given by intravenous infusion after induction of general anesthesia. Postoperatively, 1 g of paracetamol will be given to all cases every 8 hours.
~Drug: Ketorolac In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases Drug: Nalbuphine Nalbuphine boluses 0.1 mg. /kg will be given as rescue analgesia if VAS is more than 3.
~Device: ultrasound-guided nerve block Transmuscular quadratus lumborum block"
15860659|NCT03956966|Drug|TQL block with Bupivacaine and dexamethasone|"Drug: dexamethasone
~1 mL dexamethasone 4mg administered on each side as bilateral TQL blocks drug: Bupivacaine 20 ml Bupivacaine hydrochloride 0.25% administered on each side as bilateral TQL blocks Drug: fentanyl With induction of general anaesthesia, fentanyl (1 microgram.kg) will be given. Intraoperatively, fentanyl boluses (0.5 microgram.kg) will be given in case of increase in MBP or HR of more than 20% of baseline for longer than 5 minutes.
~Drug: Paracetamol Paracetamol infusion (15 mg.kg) will be given by intravenous infusion after induction of general anesthesia. Postoperatively, 1 g of paracetamol will be given by intravenous infusion to all cases every 8 hours.
~Drug: Ketorolac In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases Drug: Nalbuphine Nalbuphine boluses 0.1 mg. /kg will be given as rescue analgesia if VAS is more than 3.
~Device: ultrasound-guided nerve block Transmuscular quadratus lumborum block"
15860660|NCT03956953|Drug|BMS-986165|Dose 1 or Dose 2 on Day 1, and from Days 5-19'
15860661|NCT03956953|Other|Placebo|Placebo matching Dose 1 or Dose 2 on Day 1, and from Days 5-19
15860662|NCT03956940|Device|Intplex test|Blood sample at baseline, 15 days, 4-8-16 weeks and then every 12 weeks
15860663|NCT03956927|Other|S-TPE|S-TPE stimulation session with groups of 8 patients. The simulation is performed by a single patient, the others are observers in a neighbouring room where the scene is projected.
15860664|NCT03956927|Other|Questionnaires|Pre- and post-simulation administration of self-efficacy and anxiety questionnaires (IASTA Y1 and Y2)
15860665|NCT03956914|Other|Placebo|Placeob water 440 ml/day for 8 weeks
15860666|NCT03956914|Other|Deep sea water|Deep sea water 440 ml/day for 8 weeks
15861017|NCT03954262|Behavioral|observation of propofol ANS response|received an induction bolus or TCI infusion of propofol
15860667|NCT03956901|Other|pvi guided fluid management|"GDFM Group: 500 ml bolus crystalloid after
~2 ml \ kg crystalloid infusion to be started
~If PVI <13 MAP is <65 mmHg, continue infusion of fluid, 1-2 µg NE bolus to be entered after 5 min.
~PVI <13 MAP> 65 mmHg to continue fluid infusion If PVI> 13 MAP <65 mmHg, 250 ml bolus crystalloid \ colloid will be given and bolus 1-2 µg NE, If it continues after 5 minutes, liquid and NE doses will be repeated. Liquid treatment will be continued until PVI <13.
~PVI> 13 MAP <65 mmHg 250 ml bolus fluid to be given, if continued 5 minutes later to be repeated,repetition of fluid will continue until PVl <13."
15860668|NCT03956888|Drug|N-acetylcysteine|All COPD patients will be treated with N-acetylcysteine at the dose of 1200 mg per day (600 mg three times a day) for 4 weeks in addition to their current COPD medications without other mucolytic agents
15860669|NCT03956875|Other|yoga|yoga is a mind-body practice that guides the body through a series of poses and breathing exercises
15860670|NCT03956862|Drug|GB001|film-coated oral tablet
15860671|NCT03956862|Drug|Placebo|film-coated oral tablet
15860672|NCT03956849|Other|Training COACH Conversationstarter|"After elaborating perceived barriers and facilitators via surveys and semi-structured focusgroups, a short training with the COACH Conversationstarter will be provided to a part of the participants. The COACH Conversationstarter will be provided to the participants attending the training, which they can use in the next couple of months. After a period of time all participants will be provided with a second questionnaire, and results of the group that received the COACH Conversationstarter will be compared with the group that didn't receive the COACH Conversationstarter. (A part of) the participants that used the COACH Conversationstarter will be interviewed about their experiences.
~However, the study will have an observational design, since the decision if a professional is attending the training is not based on the investigator / protocol, but depending on the professional, for example logistic reasons. This is part of routine education."
15860673|NCT03956836|Diagnostic Test|ROTEM parameters, platelet function assay (PFA-100), von Willebrand and Factor XIII|ROTEM parameters, platelet function assay (PFA-100), von Willebrand and Factor XIII at baseline (before surgery) and after 4h and 48 after surgery in 40 patients undergoing CRC
15860674|NCT03956823|Drug|telmisartan|Telmisartan group: telmisartan 80 mg once a day
15860675|NCT03956823|Drug|amlodipine|amlodipine group: amlodipine 5 mg once a day
15860676|NCT03956810|Other|On-demand transportation|On-demand scheduling via telephone, web portal, or the broker's mobile application.
15860677|NCT03956810|Other|Usual transportation|Usual transportation scheduling via call-center.
15860678|NCT03956797|Device|Recens Cooling Anesthesia Device|Application of cooling anesthesia device prior to intravitreal injection
15860679|NCT03956784|Device|E-assessed clinical and biological follow up|"Clinical questionnaire: self-evaluation of pain (0 to 10), resumption of transit, bleeding, fever, pulse. In case of no filling, the patient is contacted.
~An automatic alert system is defined and divide the patient according to three situations:
~Normal situation
~Situation requiring the nurse to call back the patient and contact the surgeon if the assessment requires medical advice
~Disturbing situation requiring contact of the first-line surgeon if a potentially serious event is suspected. Each speaker's place is described for each item in the detailed protocols
~Biological questionnaire:
~Biological monitoring (blood count, Ionogram, C-Reactive Protein, urea, creatinine) is performed on D1, D3 and D7.
~All information is accessible in real time by the surgeon who receives notifications by email and on his smartphone in case of clinical or biological abnormality on patient monitoring."
15860680|NCT03956784|Other|Usual at home follow up|"An information sheet on the clinical parameters to be monitored will be given to patients and will include the following information:
~Immediate complications and warning signs:
~Tachycardia> 120 bpm
~Dyspnea
~Rectorragies and / or melena
~Vomiting with or without presence of blood
~Major abdominal pain (visual analogue scale> 6/10)
~Fever> 38
~Management to deal with complications: call the service and / or the surgeon
~Actions to be performed by the patient after the exit:passage of the nurse during 10 days for anticoagulant morning and evening (identical in both study groups)
~Each patient will be given a prescription to perform a C-Reactive Protein assay on D1, D3 and D7, similarly."
15860681|NCT03956771|Behavioral|Real neurofeedback|Regulation of brain activity in real-time with feedback from brain activity measured with MRI from the orbitofrontal cortex of the participant him/herself. Participants receive feedback of their own brain activity in a screen with pictures. Participants are instructed to try to decrease the pictures transparency to reduce the orbitofrontal cortical activity. Psychotherapy strategies to decrease brain responses will be teach to the participants before the intervention.
15860682|NCT03956771|Behavioral|Sham neurofeedback|Regulation of brain activity in real-time with feedback from brain activity measured with MRI from the orbitofrontal cortex of other participant. Participants receive feedback of other participant' brain activity in a screen with pictures. Participants are instructed to try to decrease the pictures transparency to reduce the orbitofrontal cortex activity. Psychotherapy strategies to decrease brain responses will be teach to the participants before the intervention.
15860683|NCT03956758|Other|Semi-directed interview|Semi-directed interview on ChemSex practice
15860684|NCT03956745|Behavioral|sleep-wake timing|Study participants will have one inverted day when they are scheduled to sleep ~12h opposite their usual sleep time.
15860685|NCT03956745|Behavioral|constant routine|Study participants will spend ~28-50 hours awake, inactive, sitting in bed, in constant lighting and temperature.
15860686|NCT03956732|Dietary Supplement|Milk Protein (high)|High protein yoghurt which contains approx. 10 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) 6 days a week.
15860687|NCT03956732|Dietary Supplement|Vitamin D|One daily tablet containing 20 μg of vitamin D3, cholecalciferol.
15860688|NCT03956732|Dietary Supplement|Milk Protein (medium)|Ordinary yoghurt containing approx. 3.3 g protein per 100 g. Participants will be asked to consume 300 g (=3 dl) 6 days a week.
15860689|NCT03956719|Drug|Autologous adipose-derived mesenchymal stem cells|Autologous adipose-derived mesenchymal stem cells is extracted from human abdominal fat, which is crushed, filtered and immediately returned to the articular cavity through a specific device.
15860690|NCT03956719|Procedure|abdominal liposuction|50 ml abdominal fat was extracted by abdominal liposuction to prepare autologous adipose-derived mesenchymal stem cells
15860691|NCT03956706|Radiation|Stereotactic Radiosurgery|Stereotactic radiosurgery dose escalation by either 18, 20, or 22 Gy to the subventricular zone in addition to standard of care
15878290|NCT03817957|Drug|Polyglucoferron|intravenous administration
15860692|NCT03956693|Behavioral|HEADS: UP|"HEADS: UP comprises 9 x 2.5 hour mindfulness teaching sessions and a silent retreat in week 7. Course materials include accessible information packs and resources to complement class-based sessions.
~The first week of the 9-week course is an introductory class. The purpose of the introductory class is to give participants the opportunity to meet the trainers and to decide if they want to learn more about mindfulness. The introductory session also allows participants to meet other people on the course and to share their (stroke) stories."
15860693|NCT03956680|Drug|BMS-986301|Specified dose on specified days
15860694|NCT03956680|Biological|Nivolumab|Specified dose on specified days
15860695|NCT03956680|Biological|Ipilimumab|Specified dose on specified days
15860696|NCT03956667|Other|Live Music|Musicians from Cascade Music will provide recruited participants in the experimental arm with high-quality calming, distracting music during their Emergency Department procedure.
15860697|NCT03956654|Drug|Ribociclib|combination of ribociclib and letrozole
15860698|NCT03956641|Other|Adaptated Physical Activity|Evaluation of the physical condition and the quality of life during the course of treatment (after 8 weeks of treatment) and at the end of the treatment's line (except for breast cancer patients)
15860699|NCT03956628|Behavioral|stay safe program|Prevention consist of 5-6 lessons having topics about learning safety skills which includes identifying touch, safe and unsafe environment/events, bullying, the good or bad secrets and strangers.
15860700|NCT03956615|Other|Blood sampling and bone marrow analysis|Bone marrow sample analysis. A blood sampling of maximally 10 ml by venous puncture (serum)
15860701|NCT03956602|Other|Pretzels|To examine postprandial responses of pretzel consumption
15860702|NCT03956602|Other|Brazil nuts|To examine postprandial responses of Brazil nut consumption
15860703|NCT03956602|Other|Potato chips|To examine postprandial responses of potato chip consumption
15860704|NCT03956602|Other|Mixed nuts|To examine postprandial responses of mixed nut consumption
15860705|NCT03956589|Drug|Orkambi|Open label of Orkambi treatment during 3 months
15860706|NCT03956576|Other|[Pyr]apelin-13|Peptide [Pyr]apelin-13 infusion
15860707|NCT03956563|Device|Youlaser MT Group 2|"Youlaser MT is a laser device including two laser sources emitting at 10600 nm (CO2) and 1540 nm (Ga-As) intended to be used for gynaecological applications.
~Each patient in the control arm will receive 3 simulated laser treatments every 30 days.
~A placebo consists in a sham device laser that simulates the acoustic signal even if it does not deliver any laser radiation to the subject."
15860708|NCT03956563|Device|Youlaser MT Group 1|"Youlaser MT is a laser device including two laser sources emitting at 10600 nm (CO2) and 1540 nm (Ga-As) intended to be used for gynaecological applications.
~Each patient in the active arm will receive 3 laser treatments with the laser: one treatment administration every 30 days."
15860709|NCT03956550|Drug|REGN5069|Intravenous (IV) Dose every 4 weeks (Q4W)
15860710|NCT03956550|Drug|Matching Placebo|Intravenous (IV) Dose every 4 weeks (QW4)
15860711|NCT03956537|Device|NEO Pedicle Screw System™|The NEO Pedicle Screw System™ is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion.
15860712|NCT03956537|Device|Neo Cage System™|Neo Cage System™ is intended to be used with bone graft material to facilitate interbody fusion and to be used with the NEO Pedicle Screw System™
15860713|NCT03956524|Biological|EuTCV|Single 0.5 mL dose of TCV of EuBiologics co., Ltd.
15860714|NCT03956524|Biological|Typbar-TCV™|Single 0.5 mL dose of TCV of Bharat Biotech
15860715|NCT03956524|Biological|Typhim Vi®|Single 0.5 mL dose of Vi capsular polysaccharide vaccine of Sanofi Pasteur
15860716|NCT03956511|Other|Spontaneous Breathing Trial|It involves placing an infant from invasive mechanical pressure limited time cycled ventilation ventilation to endotracheal continuous positive end-expiratory pressure (ET-CPAP) for a period of 5 minutes during which saturation and heart rate are closely monitored. The infant would pass the test if there is no hypoxia or bradycardia during the test. If the infant has either bradycardia for more than 15 seconds and/or a fall in SpO2 below 85% despite a 15% increase in FIO2, the study will be stopped and ventilation will be restarted.
15860717|NCT03956498|Other|Patients with cervix or vaginal cancer treated by radiotherapy and brachytherapy|"Nurse-led sexological consultations, beginning before brachytherapy and until 2 months after brachytherapy.
~Questionnaires to be completed by the patient before brachytherapy, 2 months after the end of brachytherapy and 1 year after the end of brachytherapy : Female Sexual Function Index (FSFI), Quality of Life Questionnaire-Core 30 (QLQ-C30), and Quality-of-Life questionnaire cervical cancer module QLQ-CX24."
15860718|NCT03956485|Other|Type of center|Tertiary versus non-tertiary
15860719|NCT03956472|Procedure|Osteopathic protocol for improving drainage of LCS|Osteopathic intervention improving drainage of LCS and cerebral blood flow through opitmizing veinous circulation
15860720|NCT03956472|Device|PEEP 10cmH2O|Breathing through a 10 cmH2O expiratory resistance for 10 min every 2 hours during 10h at 3842m high
15860721|NCT03956472|Other|Fake Osteopathic protocol|Placebo intervention
15860722|NCT03956472|Other|PEEP-Sham|PEEP 0 cmH2O (hidden)
15860723|NCT03956459|Other|Patients with a cancer for which a FDG-PET scanner must be performed|"For each patient, 2 consecutive PET-CT scanners will be performed using 2 different systems of PET-CT scanners:
~Discovery MI
~Discovery IQ
~Only one contrast agent injection (FDG) will be given for both scanners."
15860724|NCT03956446|Drug|Doxycycline|Beside symptomatic therapy, patients will receive oral Doxycycline 100 mg, Doxy® twice daily.
15860725|NCT03956446|Drug|Symptomatic therapy|Patients will receive symptomatic therapy with antipyretics, analgetics, antiemetics, and parenteral hydration: metamizole, Analgin®, paracetamol, Lekadol®, thiethylperazine, Kytril®, saline. Questionnaire Subjects will be asked to answer a questionnaire asking about the presence and frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia.
15860726|NCT03956446|Other|Questionnaire|Subjects will be asked to answer a questionnaire asking about the presence and frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia.
15860727|NCT03956433|Dietary Supplement|Ready-made pancakes enriched with docosahexaenoic acid (DHA)|One portion of DHA-enriched pancakes will be eaten each day for 4 weeks.
15860728|NCT03956433|Dietary Supplement|Ready-made pancakes enriched with beta-glucan (BG)|One portion of BG-enriched pancakes will be eaten each day for 4 weeks.
15878291|NCT03817957|Drug|Ferric carboxymaltose|intravenous administration
15860730|NCT03956433|Dietary Supplement|Ready-made pancakes enriched with docosahexaenoic acid and beta-glucan (DHA+BG)|One portion of DHA+BG-enriched pancakes will be eaten each day for 4 weeks.
15860731|NCT03956433|Dietary Supplement|Ready-made pancakes enriched with docosahexaenoic acid and anthocyanins (DHA+AC)|One portion of DHA+AC-enriched pancakes will be eaten each day for 4 weeks.
15860732|NCT03956420|Behavioral|Premedication visit|detailed information about surgery, anaesthesia and postoperative period
15860733|NCT03956420|Dietary Supplement|Preoperative period|avoidance of prolonged fasting, intake of fluids with carbohydrates before surgery
15860734|NCT03956420|Drug|Preoperative period|administration of melatonin 5 mg in the evening and pregabalin 75 mg one hour before entering the operating theatre
15860735|NCT03956420|Other|Postoperative period|Fluids 1 ml/kg/h; Discontinuation of propofol at the moment of drainage and cardiovascular system stabilization; Fluids administered orally 2 hours after extubation; Early mobilisation
15860736|NCT03956420|Other|Intraoperative period|deep temperature (necessity to maintain normothermia during the stay in the operating theatre 36 °C. Normothermia should be maintained rather than restored.
15860737|NCT03956420|Drug|Intraoperative period|Pyralgin 1 g i.v. after induction of anaesthesia; in patients allergic to Pyralginum, Perfalgan 1 g i.v.
15860738|NCT03956420|Drug|Intraoperative period|Ketamine 30 mg i.v. after induction of anaesthesia
15860739|NCT03956420|Drug|Intraoperative period|Sevoflurane 1.5 MAC higher in patients < 60 years old
15860740|NCT03956420|Drug|Intraoperative period|Propofol infusion in patients at risk of postoperative vomiting (Apfel ≥ 2 points), sevoflurane administration at the moments of strong stimuli from the operating field
15860741|NCT03956420|Drug|Intraoperative period|Continuous infusion of balanced multi-electrolyte fluids 1-3 ml/kg/h
15860742|NCT03956407|Device|Repetitive peripheral nerve stimulation|Active repetitive peripheral nerve stimulation will be applied to the median nerve of the affected forearm with surface electrodes. The stimulator will be set to deliver bursts of 10 Hz stimulation at 50% duty cycle (500 ms on and off). For active stimulation, intensities will be set at the highest intensity able to induce sensory paraesthesias without overt muscle contraction or pain, and adjusted if required.
15860743|NCT03956394|Diagnostic Test|UltraFast ultrasound|The patient will be hospitalized by day to perform the usual follow-up of the Takayasu disease: blood sampling and Doppler ultrasound control. Then UltraFast ultrasound doppler will be assessed.
15860744|NCT03956381|Device|Primary Total Hip Replacement with Trinity cup and TriFit TS stem via posterolateral surgical approach.|The participant will undergo surgery using the hip prostheses and surgical approach used by their surgeon Investigator. A patient specific femoral guide, generated by the OPS™ plan preoperatively, will be used during the surgical step of femoral neck resection. These are not study specific procedures as the OPS™ system is already in use by the surgeon Investigator in their standard of practice.
15860745|NCT03956381|Device|Primary Total Hip Replacement with Trinity cup and MetaFix stem via direct anterior surgical approach|The participant will undergo surgery using the hip prostheses and surgical approach used by their surgeon Investigator. A patient specific femoral guide, generated by the OPS™ plan preoperatively, will be used during the surgical step of femoral neck resection. These are not study specific procedures as the OPS™ system is already in use by the surgeon Investigator in their standard of practice.
15860746|NCT03956368|Drug|Atorvastatin 20mg|20mg (every evening orally) for 8 weeks.
15860747|NCT03956368|Drug|Placebos|20mg (every evening orally) for 8 weeks.
15860748|NCT03956355|Drug|Tapinarof (DMVT-505)|Tapinarof cream, 1%, applied once daily
15860749|NCT03956355|Drug|Vehicle Cream|Vehicle cream applied once daily
15860750|NCT03956329|Other|Standardised Digital Intervention|Video intervention designed to induce an increase in positive mood in older adults. Includes comedy clips, uplifting music and positive imagery. Intervention approximately 15-20 minutes in length. This includes 3 short comedy clips (fork handles sketch, the two Ronnie's; A room with a view - faulty towers; Tim Vine Live stand-up extract), uplifting music (Jailhouse Rock - Elvis Presley; Happy Together - The Turtles), jokes and positive imagery. The content of the intervention has been informed by patient and public involvement, focus groups with older adults, and pilot testing.
15860751|NCT03956329|Other|Individualised Digital Intervention|Similar to the standardised digital intervention, however, participants will be able to individualise the intervention by choosing video clips from a limited menu of choices. Intervention approximately 15-20 minutes in length. The 4 categories include stand-up comedy (Michael McIntyre, Tim Vine and Victoria Wood), sit-com (Fawlty Towers, Only Fools and Horses and Two Ronnies), music (Elvis Presley, Last Night at the Proms, Roy Orbison) and variety (Britain's Got Talent, Strictly Come Dancing, Terry Wogan). Participants are able to select 3 of the videos, which are roughly 5 minutes in length, to reach a total of 15-20 minutes of content.
15860752|NCT03956316|Device|Titan Modular Total Shoulder System|total shoulder arthroplasty using the Titan Modular Total Shoulder System
15860753|NCT03956303|Drug|Chirocaine %0.5|Levobupivacaine 8 mg Chirocaine (% 0.5) +20 mcg fentanyl
15860754|NCT03956303|Drug|Chirocaine Heavy 40|Chirocaine (%0.75) + Dextrose 40 mg+20 mcg fentanyl
15860755|NCT03956303|Drug|Chirocaine Heavy 60|Chirocaine (%0.75) + Dextrose 60 mg+20 mcg fentanyl
15860756|NCT03956303|Drug|Chirocaine Heavy 80|Chirocaine (%0.75) + Dextrose 80 mg+20 mcg fentanyl
15860757|NCT03956290|Behavioral|TREAT pilot intervention|Participants will be asked to use the app and take pictures of everything they eat and drink, from the time they get up to the time they go to bed, regardless of size of meal/snacks/drink, for 2 weeks. This will generate data on their eating pattern and eating duration. Participants will be reminded through app, call or text by study staff based on personalized eating schedule. The sleep schedule will also be recorded.
15860758|NCT03956277|Device|PUG|This methodology involves using ultrasound to place gastrostomy tube (g-tube itself is off the shelf).
15860759|NCT03956264|Device|Virtual Reality|Deepsen offers a VR platform that provides patients with immersive contents aimed to distract, inform, soften and improve the healthcare experience
15860760|NCT03956264|Drug|Kalinox|Gas mixture composed of 50% Nitrous Oxide and 50% Oxygen
15860761|NCT03956251|Procedure|Combined Mineralized/Demineralized Putty Allograft|At time of extraction, 15 test patients will receive ridge preservation using Combined Mineralized/Demineralized Putty Allograft
15860762|NCT03956251|Procedure|Demineralized Putty Allograft|At time of extraction, 15 control patients will receive ridge preservation using Demineralized Putty Allograft
15860763|NCT03956238|Behavioral|Alcohol intoxication|Men and women assigned to moderate alcohol dose condition (target BAC .08%) or placebo control condition with NIAAA approved alcohol administration procedures
15860764|NCT03956238|Behavioral|Objectification|Women assigned to objectifying gazes condition or eye contact control condition
15860765|NCT03956225|Device|Systane iLux® Dry Eye System|Commercially available medical device intended for use by qualified eye care professionals to apply localized heat and pressure therapy to a patient's eyelids.
15860766|NCT03956225|Device|LipiFlow® Thermal Pulsation System|Commercially available medical device intended for use by qualified eye care professionals to apply localized heat and pressure therapy to a patient's eyelids.
15860767|NCT03956212|Drug|Doxycycline 7 days|Patient will be treated with doxycycline orally, 100 mg, bid, 7 days
15860768|NCT03956212|Drug|Doxycycline 14 days|Patient will be treated with doxycycline orally, 100 mg, bid, 14 days
15860769|NCT03956199|Procedure|pulpotomy|removal of the pulp from pulp chamber
15860770|NCT03956199|Procedure|Root canal treatment|Removal of at the entire content of the root canal system and root canal obturation
15860771|NCT03956173|Other|Hypoglycemic combined with either normo or hyperglycemic clamp.|Twenty-four patients with type 1 diabetes has been recruited for a cross-over study including two experimental days, a combined hypo- and hyperglyemic clamp and a combined hypo- and euglycemic clamp, respectively. Patients will be randomised 1:1 to start with either the combined hypo- and hyperglycemic or the hypo- and euglycemic clamp. The hypo- and hyperglycemic or the hypo- and euglycemic clamp are estimated to last 255 minutes. The two clamp days will be separated by at least 30 days.
15860772|NCT03956160|Other|A co-design phase aims to ensure the feasibility and relevance of the proposed intervention and evaluation.|"4 participatory co-design workshops lasting 4 hours each that will follow a user-centered design approach: identification of end-user needs, prototyping/development of the intervention (case-management procedures and platform), iterative improvement, end-user testing.
~Based on the cognitive social theory underpinning the intervention, scientific literature, an overview of existing organizations and the results of the Stroke 69 and Arthur Tybra studies (patient needs following the acute phase), the advisory committee will:
~Define the case-manager's profile, and required knowledge and skills
~Identify the resources and tools to be proposed on the Internet platform
~Test the tools and content
~Refine the program evaluation criteria
~Test and validate the study procedures."
15860773|NCT03956147|Other|Munich Shoulder Questionnaire|Validation and Reability study
15860774|NCT03956134|Drug|Tapentadol Test Product 1|Tapentadol tablet containing 116 mg of tapentadol hydrochloride; Tapentadol Test Product 1 contains different amounts of excipients than Tapentadol Test Product 2
15860775|NCT03956134|Drug|Tapentadol Test Product 2|Tapentadol tablet containing 116 mg of tapentadol hydrochloride; Tapentadol Test Product 2 contains different amounts of excipients than Tapentadol Test Product 1
15860776|NCT03956134|Drug|Tapentadol Prolonged-release Reference Product|Tapentadol PR tablet containing 116 mg of tapentadol hydrochloride
15860777|NCT03956121|Other|injection of magnesium sulfate|The intervention consists to perform a study of the usual fetal heart rate with, in addition, comparison analysis of the short-term variability before and after injection of magnesium sulfate in the exposed group. Two successive short-term variability analyzes will be performed in fetuses of the control group.
15860778|NCT03956108|Diagnostic Test|MRI+targeted biopsies+Stockholm3-test|MRI, evaluation in accordance with PI-RADS v2, and targeted biopsies. Stockholm3-test.
15860779|NCT03956108|Diagnostic Test|PSA + systematic biopsies|Systematic biopsies and PSA test
15860780|NCT03956095|Dietary Supplement|Ensure Surgery Immunonutrition Shake supplements|Three Ensure Surgery Immunonutrition Shake supplements per day for seven days prior to their scheduled procedure.
15860781|NCT03956095|Other|Daily Food Intake form|On the day of surgery, the patient will return her Daily Supplement/Food Intake Forms and complete the Day of Surgery Intake Form can also be completed the day before surgery and the Daily Supplement/Food Intake Forms can be returned at the patient's postoperative appointment.
15860782|NCT03956082|Device|Ultravision System|Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation
15860783|NCT03956069|Biological|blood sample|for patient and its parents
15860784|NCT03956069|Genetic|genome sequencing|whole genome sequencing
15860785|NCT03956056|Biological|Neoantigen Peptide Vaccine|• Each pool of vaccine study drug + poly IC:LC will be administered to one of the four limbs (A - Right Arm, B - Left Arm, C - Right Leg, D - Left Leg) by subcutaneous (SC) injection.
15860786|NCT03956056|Drug|Poly ICLC|• Each pool of vaccine study drug + poly IC:LC will be administered to one of the four limbs (A - Right Arm, B - Left Arm, C - Right Leg, D - Left Leg) by subcutaneous (SC) injection.
15860787|NCT03956056|Procedure|Blood for immune monitoring|-Baseline, day 1, day 22, day 50, day 78, week 25, and week 73
15860788|NCT03956030|Other|Contraception Handout|Handout covering contraception options
15860789|NCT03956030|Other|Nutritional Handout|Handout covering nutrition
15860790|NCT03956017|Drug|Ubiquinone|Take oral tablets as directed (2x200 mg for 3 days prior to surgery)
15860791|NCT03956017|Drug|Placebo|Take oral tablets as directed (2x200 mg for 3 days prior to surgery)
15860792|NCT03956004|Other|OM1 Dell Shared Decision Making Tool|Decision aid meant to improve shared decision making among patients and providers.
15860793|NCT03956004|Other|Education material from OM1 Dell Shared Decision Making Tool|Investigator-written educational material and quiz to test knowledge of osteoarthritis and treatment options.
15860794|NCT03955991|Behavioral|R-CBSM|10 weekly educational modules via an electronic tablet. A participant workbook is also provided that contains a summary of the rationale for each module, outline of each technique, and homework exercises.
15860795|NCT03955991|Biological|Influenza vaccine|Standard of care Influenza vaccine for that given year.
15860796|NCT03955978|Drug|TSR-042|-TSR-042 is administered intravenously via a 30-minute (-5-minute/+15-minute infusion window allowed) infusion
15860921|NCT03955042|Drug|Pemetrexed|Pemetrexed 900 mg/m^2 on Day 1 of each 21-day cycle. Supportive medications of ibuprofen, folic acid, vitamin B12, and dexamethasone.
15861274|NCT03952325|Drug|Atezolizumab|Atezolizumab at 1,200 mg by intravenous infusion Q3W
15860797|NCT03955978|Radiation|Brachytherapy|-This trial will include image-guided brachytherapy with three-dimensional (3-D) treatment planning and in cases where pelvic radiation is deemed appropriate by the treating radiation oncologist, external beam radiation therapy (EBRT) using intensity modulated radiation therapy (IMRT) technique.
15860798|NCT03955978|Procedure|Endometrial biopsy|-Prior to the start of treatment with TSR-042. If this biopsy yields insufficient tumor tissue, an archival sample may be requested, with Fraction 1 of brachytherapy, with Fraction 6 of brachytherapy
15860799|NCT03955978|Procedure|Blood draw for immune response|-Prior to the start of any treatment, weekly during RT (at the time of each brachytherapy treatment), prior to fourth dose of TSR-042, 6 weeks after the completion of all protocol related therapy
15860800|NCT03955965|Other|Medication reconciliation|No intervention was performed other than collecting data on patients' medical files
15860801|NCT03955952|Procedure|Bariatric Surgery|"Patients chosen using the following codes:
~Current Procedural Terminology (CPT): 43633, 43634, 43770, 43775, 43644, 43645, 43659, 43842, 43843, 43844, 43845, 43846, 43847 International Classification of Diseases (ICD): 44.31, 43.82,44.95, 43.89, 44.38, 44.39, 44.68 Healthcare Common Procedure Coding System (HCPCS): S2082, S2085"
15860802|NCT03955939|Drug|LY3295668 Erbumine|Administered orally.
15860803|NCT03955939|Drug|Endocrine therapy|Administered according to label instructions.
15860804|NCT03955939|Drug|Midazolam|Administered orally.
15860805|NCT03955926|Dietary Supplement|preoperative oral carbohydrate loading|Carbohydrate beverage (12.8% carbohydrates, 50 kcal/100 mL, 290 mOsm/kg) 800 mL is given to the NO-NPO group until 2 hours before surgery
15860806|NCT03955913|Other|Archival Tumor Tissue Sample|Percentage of participants with UC and selected FGFR aberrations will be assessed through molecular testing of their archival tumor tissue.
15860807|NCT03955900|Other|No intervention|Both retrospective and prospective data will be collected. The retrospective data will be collected through medical chart review.
15860808|NCT03955887|Biological|bronchoalveolar lavage fluid (BAL)|Recovery of a 10 mL volume of BAL fluid, performed as part of patient care
15860809|NCT03955887|Biological|Venous blood|Collection of 3 additional blood tubes (12 ml) during a blood sample taken as part of patient care
15860810|NCT03955861|Biological|adalimumab|Subcutaneous injection
15860811|NCT03955861|Biological|Certolizumab|Subcutaneous injection
15860812|NCT03955861|Biological|Etanercept|Subcutaneous injection
15860813|NCT03955861|Biological|Golimumab|Subcutaneous injection
15860814|NCT03955861|Biological|Secukinumab|Subcutaneous injection
15860815|NCT03955848|Biological|Alloreactive NK cell infusion|Alloreactive NK cell infusion
15860817|NCT03955822|Other|Phone survey|Phone Survey in order to evaluate adverse effect of the permanently implanted birth control device for women (Essure) will be proposed to wmen Treated between 2002 and 2017 with Essure.
15860818|NCT03955809|Drug|Ketamine 0.5|İntrarticular Ketamine 0.5 mg/kg + 0.9 Nacl Total Volume 20 ml
15860819|NCT03955809|Drug|Ketamine 1|İntrarticular Ketamine 1 mg/kg + 0.9 NaCl Total Volume 20 ml
15860820|NCT03955809|Drug|% 0.9 NaCl|Intraarticular %0.9 NaCl
15860821|NCT03955796|Device|Hydrophobic IOL|RayOne Hydrophobic Aspheric, hydrophobic IOL
15860822|NCT03955796|Device|Non-hydrophobic IOL|RayOne Aspheric, non-hydrophobic IOL
15860823|NCT03955783|Drug|Venetoclax|Given by mouth
15860824|NCT03955783|Drug|Selinexor|Given by mouth
15860825|NCT03955770|Combination Product|High-flow oxygen therapy (HFOT)|HFOT will be applied by a dedicated large bore nasal cannula (Optiflow+, Fisher&Paykel, New Zealand) at a flow rate 60 L/min, FiO2 45%, temperature 32 °C, using a HFOT device (myAIRVO2, Fisher&Paykel, New Zealand).
15860826|NCT03955770|Combination Product|Low-flow oxygen therapy (LFOT)|LFOT will be provided by a standard nasal cannula at a flow rate of 3 L/min using an oxygen concentrator (EverFlow, Philips Respironics).
15860827|NCT03955757|Behavioral|Boot Camp Translation|Communities in the intervention arm will participate in the Boot Camp translation process, where stakeholders will come together to develop and implement locally relevant materials to promote adolescent vaccination.
15860828|NCT03955757|Other|Control|No intervention. Communities will continue to behave as usual.
15860829|NCT03955744|Other|3D translabial ultrasound|All patients will undergo 3D translabial ultrasound with vaginal manometry
15860830|NCT03955731|Device|Magmaris resorbable magnesium scaffold|Implantation of Magmaris resorbable magnesium scaffold
15860831|NCT03955718|Behavioral|Motherly App|The Motherly app is a behavioral intervention aimed at preventing maternal depression and promoting child development.
15860832|NCT03955718|Behavioral|Educational App (Active Control)|An app with educational content about gestation, maternal health and mental health, child development, etc.
15860833|NCT03955705|Drug|Nefopam 20 mg/ml|Nefopam is a benzoxazocine derivative which is non-opioid and non NSAIDs. The previous studies showed that nefopam can inhibit reuptake of serotonin, norepinephrine and dopamine.
15860834|NCT03955705|Drug|Normal saline|0.9% Sodium chloride (normal saline or NSS)
15860835|NCT03955692|Device|tDCS|Five sessions (active/sham) will be held on five consecutive days. The parameter of electrode size, current strength and current duration were previously tested for safety in children
15860836|NCT03955679|Genetic|AVXS-101|AVXS-101 is a non-replicating recombinant adeno-associated virus serotype 9 (AAV9) containing the human survival motor neuron (SMN) gene under the control of the cytomegalovirus (CMV) enhancer/chicken β-actin-hybrid promoter (CB). AVXS-101 will be administered as a one-time intravenous infusion over approximately 60 minutes. Dosage will be determined by the participants weight.
15860837|NCT03955666|Biological|PRV-3279 or placebo|bi-specific antibody-based molecule
15860838|NCT03955653|Procedure|Femoral artey access|We will study the access to the femoral artery for cardiac catheterization or percutaneous coronary intervention
15860843|NCT03955627|Behavioral|Relieving Joint Pain and Improving AI Adherence in Older Breast Cancer Survivors (REJOIN)|Self-management program which includes supervised exercise sessions in groups and group discussions for 8 weeks conducted by Zoom video, followed by an 8-week home-based version of the same program participants do on their own with bi-weekly coaching calls.
15860844|NCT03955614|Other|pedal-controlled GoSurgeryTM|"Members of the surgical team are given operative instruction workflows to use in preparation of a specific operation and to consult during the operation if needed. The workflows are controlled by the surgical staff using pedals.
~The operating theatre environment is recorded to observe how teamwork may be affected by the intervention."
15860845|NCT03955614|Other|ML-controlled GoSurgeryTM|"Members of the surgical team are given operative instruction workflows to use in preparation of a specific operation and to consult during the operation if needed. The workflows are projected onto screen based on the machine learning algorithm's determination of current operative step.
~The operating theatre environment is recorded to observe how teamwork may be affected by the intervention."
15860846|NCT03955614|Other|NoGo|The operating theatre environment is recorded to observe baseline teamwork.
15860847|NCT03955601|Drug|Haploidentical HSCT using TBI free regimen, ''ATG'' with ''Post transplant cyclophosphamide''|''Busulphan'' will be used in place of ''TBI'' in equivalent myelotoxic dose to facilitate engraftment , ''ATG'' will be used to reduce GVHD and facilitate engraftment while ''combine PBSC'' and/OR ''Bone marrow harvest'' will be used
15860848|NCT03955588|Diagnostic Test|aCGH|
15860849|NCT03955575|Drug|Liraglutide 6 MG/ML|Liraglutide as injections.
15860850|NCT03955575|Drug|Colesevelam|3 x 625 miligram 2 times a day.
15860851|NCT03955562|Other|Footbridge|Access to a pedestrian footbridge.
15860852|NCT03955562|Other|Comparison villages|Villages that do not receive a footbridge.
15860853|NCT03955549|Behavioral|Insight Enhancement Program (IEP)|"IEP is comprised of 8 sessions, administered twice weekly, across a one month period. The session duration is 60-90 minutes. IEP will be administered in a group format with 8-12 patients in each group.
~During sessions, different topics representing 8 different stages of illness are discussed according to a chronological schedule. These stages are presented on an Illness March Graph (IMG) and include: Stage I: Personality formation, Stage II: Pre onset confusion, Stage III: Prodroma, Stage IV: The illness, Stage V: Resistance, Stage VI: Remission, Stage VII: Maintenance, Stage VIII: Relapse. Patients actively participate through the exchange of their own experiences and interpretations, which are then reinterpreted by the therapist and by the patients themselves."
15860854|NCT03955549|Behavioral|Metacognitive Training for Psychosis (MCT)|The training consists of eight modules that are administered within the framework of a group intervention program that involves eight 1-hour group sessions with 4 to 10 patients in each group. MCT is manualized and currently available in thirty languages and can been downloaded via the following web address: http://www.uke.de/mct. Among the problematic thinking styles recognized as potential contributors to the development of delusions are attributional distortions (module 1), a jumping to conclusions bias (module 2 and 7), a bias against disconfirmatory evidence (module 3), deficits in theory of mind (module 4 and 6), over-confidence in memory errors (module 5) and depressive cognitive patterns (module 8).
15860855|NCT03955549|Drug|Treatment As Usual (TAU)|"Treatment As Usual (TAU) consists of psychiatric management by a clinical team including at least one psychiatrist and one psychologist. Treatment involves antipsychotic medication, regular office-based contacts with the clinical team for treatment monitoring, recreational group activities, and unstructured psycho-educational groups. Participants in the interventional groups also will receive TAU.
~Medications: In order to standardize treatment, Risperidone (Risperdal ) will be used as the antipsychotic medication in all three groups with a dose up to 6-8 milligrams according to clinical severity. The same dose will be used for 1 month prior to starting interventions). In case of occurrence of mild extrapyramidal symptoms associated with high doses of risperidone, an anticholinergic drug (Benztropine) might be used."
15860856|NCT03955536|Other|Group A: Group routine cardiac rehabilitation program (RCRP)|"Patient education, Chest Physiotherapy, Abdominal and chest breathing, Bronchial hygiene techniques, Segmental breathing exercises, Triflow, exercise and mobilization,graduated exercise, positioning, active joint movement, moving inside bed, sitting at the edge of the bed, transfer from bed to chair, standing walking program, up and down stairs.
~Evaluations for each patient (preoperative and just before discharge) Spirometric measurements Intraoral pressure measurementDyspnea assessment (BORG), Pain assessment (VAS), Evaluation of anxiety and depression (HAD) Evaluation of functional capacity (6 minutes walking test) Quality of Life (MacNew Heart Disease Specific Quality of Life Questionnaire)"
15860857|NCT03955536|Other|Group B: Group RCRP and inspiratory muscle training|"use of additional virtual reality goggles in the routine cardiac rehabilitation program Virtual reality glasses installed in the patient will feel the best way to feel an environment.
~Virtual reality glasses are planned to be used 15 minutes by increasing the usage period.
~Evaluations for each patient (preoperative and just before discharge) Spirometric measurements Intraoral pressure measurementDyspnea assessment (BORG), Pain assessment (VAS), Evaluation of anxiety and depression (HAD) Evaluation of functional capacity (6 minutes walking test) Quality of Life (MacNew Heart Disease Specific Quality of Life Questionnaire)"
15860858|NCT03955536|Other|Group C: Group RCRP and virtual reality application|"nspiratory muscle training with Threshold for routine cardiac rehabilitation Training intensity
~- 30% of the maximum measured inspiratory pressure per week (15 min.). Every 10 breaths after rest.
~Evaluations for each patient (preoperative and just before discharge) Spirometric measurements Intraoral pressure measurementDyspnea assessment (BORG), Pain assessment (VAS), Evaluation of anxiety and depression (HAD) Evaluation of functional capacity (6 minutes walking test) Quality of Life (MacNew Heart Disease Specific Quality of Life Questionnaire)"
15860859|NCT03955523|Other|Single exercise bout trial|Exercise trial day: 30 min of continuous exercise at 60% VOpeak (or at the least 3 bouts of 10 min at 60% VO2peak separated by no more than 1 minute rest) - power output is set at that determined during the maximum test on the first visit, and adjusted accordingly if there is a deviation >5% VO2peak for at least 3 minutes of exercise.
15860860|NCT03955523|Dietary Supplement|Single diet trial|Diet trial day The protocol of the diet trial day is identical to that of the exercise trial day, except that exercise is substituted by asking the participant to eat a standardized breakfast meal that it is commonly consumed in a fast-food chain (i.e. cheese and egg McMuffin, double portion of hash browns and an orange pop).
15861275|NCT03952325|Drug|Tesetaxel|Tesetaxel at 27 mg/m2 orally Q3W
15860861|NCT03955510|Other|Right time eating|"Right-time eating means breakfast before 8am, lunch before 1 pm and dinner before 6pm. Subjects will be asked to stick to this eating schedule for 1 week. Subjects will randomly be assigned to each eating pattern during the study period. Each subject will be required to do this intervention twice during the study period. One time they will have right time eating with alcohol , the second time the will have this intervention without alcohol."
15860862|NCT03955510|Other|Delayed time eating|"Delayed-eating means eating each meal 3 hours later than the Right-time eating.Subjects will be asked to stick to this eating schedule for 1 week. Subjects will randomly be assigned to each eating pattern during the study period. Each subject will be required to do this intervention twice during the study period. One time they will have delayed time eating with alcohol , the second time the will have this intervention without alcohol."
15860863|NCT03955510|Procedure|Sigmoidoscopy|Subjects will undergo unprepped sigmoidoscopy to collect tissue and stool sample at each intervention visits (visit 2, 3, 4, and 5). Flexible sigmoidoscopy will not require any colon cleansing and it will be very limited to the most distal (closest to the end of the anus) 20 centimeters (approximately 8 inches) of the colon and thus will be far less uncomfortable than the routine flexible sigmoidoscopy.
15860864|NCT03955510|Procedure|Optional 24h circadian assessment in the Biological Rhythms lab|"Subjects may choose to participate in the 24 hour circadian assessment in the Biological Rhythms Research Lab. During this assessment, a saliva sample will be taken every hour, a mouth swab will be done every 2 hours, and rectal swab will be done twice (every 12 hours). Subjects will be kept awake in dim light on a recliner chair. Subjects can watch a television with dimmed light. Subjects will be provided with food and drink during the assessment.
~If subjects choose this intervention they will be asked to complete 4 assessment during the course of the study period."
15860865|NCT03955510|Other|Alcohol|Moderate alcohol drinking means 0.5 g/kg alcohol daily, which will be not more than 2 glasses of wine depending on subject's weight. Alcohol will always be consumed in the evening with food or after food (e.g., dinner). The timing of alcohol consumption will be consistent for each individual. Subjects will be provided with red wine for the 2 alcohol intervention weeks. The order of conditions will be random.
15860866|NCT03955497|Other|Autologous Adipose-derived Mesenchymal Stem Cell Gel|The experimental group received intra-articular injection of Autologous Adipose-derived Mesenchymal Stem Cell Gel one month after operation.
15860867|NCT03955497|Drug|Sodium Hyaluronate|The control group received intra-articular injection of sodium hyaluronate one month after operation.
15860868|NCT03955497|Procedure|Extraction of abdominal fat|In the experimental group, abdominal fat was extracted before operation to prepare Autologous Adipose-derived Mesenchymal Stem Cell Gel.
15860869|NCT03955484|Diagnostic Test|Urinary Glycosaminoglycan|Urine will be collected from patients before and after one month of medical treatment (alpha-blocker). After being centrifuged at 5000 g for 10 minutes, urine will be stored at -80 ° C. At the end of the study, urinary glycosaminoglycan levels will be studied by spectrophotometric method.
15860870|NCT03955471|Drug|Niraparib|Niraparib is a potent, orally active poly (adenosine diphosphate-ribose) polymerase (PARP)-1 and PARP2 inhibitor being developed as a treatment for participants with tumors that harbor defects in the homologous recombination deoxyribonucleic acid (DNA) repair pathway or that are driven by PARP-mediated transcription factors.
15860871|NCT03955471|Drug|TSR-042|TSR-042 is a humanized monoclonal antibody that binds with high affinity to programmed cell death-1 (PD-1) resulting in inhibition of binding to programmed cell-death receptor ligands 1 and 2 (PD-L1 and PD-L2).
15860872|NCT03955458|Drug|EXPAREL|FICB with EXPAREL + Bupivacaine HCL (single dose)
15860873|NCT03955458|Drug|Ropivacaine|FICB with continuous infusion of ropivacaine
15860874|NCT03955458|Drug|Bupivacaine Hydrochloride|FICB with EXPAREL + Bupivacaine HCL (Single dose)
15860875|NCT03955445|Drug|LNP023|LNP023 capsules
15860876|NCT03955432|Device|Reveal LINQ ICM System|The LINQ ICM (Medtronic, Inc.) is a small FDA approved cardiac monitor implanted in the subcutaneous tissue of the chest wall that is designed to continuously record a single-lead ECG, monitoring the cardiac rhythm for up to three years. The device records and stores patient's rhythm on two occasions: first when programmed criteria are met and second upon patient activation. These programmable arrhythmia criteria are based on heart rate (bradycardia, tachycardia), irregularity of heart rate and duration of rate disturbance. The LINQ ICM (or future iterations) will be utilized in this study to detect arrhythmias in our study population.
15860877|NCT03955419|Dietary Supplement|NO-NPO (Daesang WelLife Co., Ltd., Korea)|800 mL of carbohydrate beverage consists of 12.8% carbohydrates, 50 kcal/100 mL, 290 mOsm/kg.
15860878|NCT03955406|Procedure|Conventional Low flow Anesthesia|During the initial wash-in period 4 L/min Fresh gas flow will be used.
15860879|NCT03955406|Procedure|Low Flow Anesthesia with fixed fresh gas flow rate|Fresh gas flow rate will be 1 L/min throughout the procedure.
15860880|NCT03955393|Other|18F-FAZA PET IMAGING TECHNIQUE IN DETECTING LYMPH NODE METASTASES IN RENAL CELL CARCINOMA PATIENTS|18F-FAZA is a highly selective PET radiotracer of hypoxia, which has been recently developed and tested in several studies (10-14). 18F-FAZA has been demonstrated to be a marker of hypoxia and pathological metabolic patterns which are common to all renal cancers.
15860881|NCT03955380|Drug|Contraloid|Oral administration of capsules, drug substance or placebo without any exipients.
15860882|NCT03955367|Radiation|Prophylactic extended-field Irradiation|CTV covers pelvis and para-aortic lymph nodes region.
15860883|NCT03955367|Radiation|Pelvic irradiation|CTV covers pelvis.
15860884|NCT03955367|Radiation|Intracavitary brachytherapy|The total dose delivered to point A or high-risk CTV is ≥80Gy. For patients with larger-volume cervical tumor, the total dose is ≥85Gy.
15860885|NCT03955367|Drug|Concurrent chemotherapy|Cisplatin based concurrent chemotherapy, including cisplatin as a single agent or cisplatin plus Paclitaxel.
15860886|NCT03955354|Drug|SHR1210|SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
15860887|NCT03955354|Drug|apatinib mesylate|apatinib Mesylate is a small molecule tyrosine kinase inhibitor,Through selectively inhibiting the tyrosine kinase activity of the vascular endothelial growth factor receptor 2 (VEGFR-2).
15860960|NCT03954743|Biological|Lyophilized formulation of GSK's oral live attenuated HRV vaccine|2 doses administered orally at Day 1 and at Month 1 or Month 2, according to the immunization schedule for RV vaccine administration in participating countries.
15861310|NCT03952078|Drug|CPI-818|Interleukin-2 inducible T-cell Kinase Inhibitor
15860888|NCT03955341|Device|Diode laser disinfection|After collecting the first sample of dentin as described above, the cavity will be disinfected using Diode laser (EPIC™, BIOLASE) with 940 nm and an output power of 0.5 watt (24). A 400 µm noninitiated tip will be used for cavity irradiation, in a noncontact mode (2mm distance), 5 sec/mm2 in sweeping motion. A 2nd dentinal sample will be collected after diode laser disinfection.
15860889|NCT03955341|Other|Chemical disinfection using 2% Chlorhexidine|After collecting the first sample of dentin, the cavity will be disinfected using 2% Chlorhexidine (Consepsis®, Ultradent) for 20 seconds (32). Then a 2nd dentinal sample will be collected after chemical disinfection.
15860890|NCT03955328|Diagnostic Test|Magnetic Resonance Imaging|A magnetic resonance imaging is perform to detect permanent anatomical damage.
15860891|NCT03955315|Biological|IDCT|Discogenic Cells + Sodium Hyaluronate Vehicle
15860892|NCT03955315|Procedure|Sham|Needle puncture under the muscular layer in front of the intervertebral disc
15860893|NCT03955302|Behavioral|Exercise|There will be an intervention for 12 weeks. For exercises in the water, there will be an expert physiotherapist in the field of hydrotherapy that will guide the exercises in controlled sessions of approximately 45 minutes. Exercises of joint mobility, balance, strength and coordination with / without aquatic material will be included. At all times, qualified health personnel will monitor any symptom or sign that advises the removal of the subject of the study.
15860894|NCT03955276|Other|Molecularly targeted treatment matched to genomic/immunophenotypic tumor profile (chosen by treating physician)|Biologically targeted matched treatment (chosen by treating physician)
15860895|NCT03955250|Behavioral|Mobile After-Care Support (MACS) app|The MACS app assesses and intervenes by fostering increased treatment adherence (medication/appointments) and self-coping with illness (active, planned, problem-solving focused) to reduce symptoms and improve functioning.
15860896|NCT03955250|Behavioral|Mobile app attention control|The control app provides ecological momentary assessment and psychoeducation about illness.
15860897|NCT03955237|Procedure|Drug: dextrose containing infusion|Drug: infusing dextrose containing or non glucose fluid according to blood glucose level
15860898|NCT03955224|Device|Basic Oral Care + active LLLT|"Compliance with the Basic Oral Care Associated with
~Active LLLT : 5 applications performed at three days intervals (day 1 to day 13 +/- 1 day)"
15860899|NCT03955224|Other|Basic oral Care + inactive LLLT|"Compliance with the Basic Oral Care Associated with
~Inactive LLLT : 5 applications performed at three days intervals (day 1 to day 13 +/- 1 day)"
15860900|NCT03955224|Other|Basic Oral Care|Compliance with the Basic Oral Care only
15860901|NCT03955211|Drug|HTX-011|300 mg
15860902|NCT03955211|Drug|HTX-011|400 mg
15860903|NCT03955211|Device|Luer Lock Applicator|Applicator for instillation.
15860904|NCT03955211|Drug|Ibuprofen|400 mg
15860905|NCT03955211|Drug|Acetaminophen|975 mg to 1 g
15860907|NCT03955185|Procedure|minimally invasive surgery|Laparoscopic or robotic assisted radical hysterectomy
15860908|NCT03955185|Procedure|open abdominal surgery|Traditional open abdominal radical hysterectomy
15860909|NCT03955172|Drug|Everolimus|Patients will received everolimus (CERTICAN), oral form, at the necessary dose to obtain trough levels between 6 and 8 ng/ml, during 6 months. Everolimus will replace the anti-proliferative drug they have before (azathioprine or mycophenolic acid). Everolimus will be associated with corticosteroids (prednisolone) and a calcineurin inhibitor (tacrolimus or cyclosporin).
15860910|NCT03955159|Dietary Supplement|Probiotic supplementation|The probiotic is composed of the combination of Lactobacillus acidophilus and Bifidobacterium lactis, at the concentration of 109 CFU. This product presents no known hazards associated with its use. On the contrary, the use of this supplement is associated with a rebalancing of the intestinal microbiota with potential secondary benefits to the reconstitution of the intestinal symbiosis. Patients will receive 1 sachet of 1 gram per day and will be advised to dilute in 100 mL in water at room temperature for administration.
15860911|NCT03955146|Drug|Pamrevlumab|Pamrevlumab: 30 mg/kg by intravenous infusion every 3 weeks for a total of 17 infusions over 48 weeks
15860912|NCT03955146|Drug|Placebo|Placebo: 30 mg/kg by intravenous infusion every 3 weeks for a total of 17 infusions over 48 weeks
15860913|NCT03955133|Other|Adverse Drug Reaction ADRe Profile for Polypharmacy|PADRe asks nurses to systematically check patients for the manifestation of itemised adverse side effects or undesirable effects of their primary care medicines, as listed in the British National Formulary (BNF) and manufacturers' Summaries of Product Characteristics (SmPCs), and seminal texts documenting known ADRs. Nurses are asked to share the identified problems with prescribers and pharmacists overseeing medicines charts. A full description is published (references below).
15860914|NCT03955120|Behavioral|Dayzz mobile sleep training|"The dayzz digital sleep program provides each user with relevant educational materials (depending on their sleep condition), sleep tracking, and sleep or health-related tasks or challenges pertaining to their sleep or sleep difficulties.
~Each app user is matched with a sleep trainer who will communicate with them via a chat option within the dayzz app and who will support the participants with any sleep training issues or technical aspects of all app for the duration of the treatment program.
~Participants receive a wrist-worn device for monitoring sleep and activity patterns, a Fitbit fitness tracker (www.fitbit.com), to be worn for the duration of the study."
15860915|NCT03955120|Other|Treatment as usual|Standard medical care for specific sleep condition
15860916|NCT03955107|Device|Continuous Glucose Monitoring System|Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) every 4 weeks since diagnosed with GDM，and the control grouponly once receive CGMS during the last month and have management adjusted based on the CGMS readings Other Name: iPro, Medtronic
15860917|NCT03955094|Device|Intubation via AMBU® AURAGAIN™|Success rate of paediatric intubation through AMBU® AURAGAIN™
15860919|NCT03955068|Other|Strict Classic Ketogenic Diet|Diet is administered from a 2:1 to 4:1 ratio; this means 2 to 4 parts of fat to 1 part of both protein (calculated based on RDA and whatever remaining portion of carbohydrates.
15860920|NCT03955055|Device|Video Capsule Endoscopy|Patients will swallow a video capsule as soon as possible (immediately or within 10 hours, if patient is not fasting).
15878292|NCT03817957|Drug|Ferrous Sulfate|oral administration
15860922|NCT03955029|Other|Progressive Interval training|heating up 7 minutes at 15 watt, then alternating 30% of the maximum power reached by the patient at Vo2 max for 3 minutes and first peak at 40% of max power, second at 45%, third at 50%, fourth at 55 % and fifth to 60%, then return to calm 3 minutes at 15 watt. Total duration of the endurance session: 30 minutes. The powers of the peak will be modeled according to the Borg (if <6, increase by 5 watt the value of each peak at the next session).
15860923|NCT03955029|Other|Conventional Interval training|warm up 7 minutes at 15 watt, then alternating between plateau at 30% of the max power reached by the patient at VO2 max for 3 minutes and peak at 60% for 1 minute, return to calm 3 minutes at 15 watts. Total duration of the endurance session: 30 minutes. The power of the peak will be modeled according to the Borg (if <6, increase by 5 watt the value of each peak at the next session)
15860924|NCT03955016|Other|Pulmonary rehabilitation|"Rehabilitation program consisting of 2 weeks inpatient (supervised training 5 times per week), 2 weeks outpatient (supervised sessions 3 times per week) and 11 weeks home-based exercise training (weekly phone call).
~During the inpatient phase, patients will receive on top of the supervised training sessions a consultation of the dietitian, PH psychologist, social worker and specialized nurse. During the ambulatory rehabilitation phase patients will have 2 session with the occupational therapist.
~Every supervised training session contains:
~Interval training on a cyclo-ergometer
~Strength training of the upper and lower extremities
~Guided walks"
15860925|NCT03955003|Behavioral|Group Drumming|Cancer patients will be led by a Board Certified Music Therapist to participate in group drumming for one hour per week, for six weeks.
15860926|NCT03955003|Other|Attention Control|This is intended to control for time, place, and group affect.
15860927|NCT03954990|Drug|Metronidazole Oral|4 tablets (2 g of metronidazole)
15860928|NCT03954990|Drug|Placebo Oral Tablet|4 tablets
15860929|NCT03954977|Diagnostic Test|PICC line ultrasound|NICU patient's with PICC lines will be enrolled and blinded ultrasound operators will scan the neonate to find the PICC tip location. This will be compared to the location on the patient's chest x-ray. This process will be repeated each time the patient has a chest x-ray.
15860930|NCT03954964|Behavioral|Education on disposal of opioids|Current class curriculum including education about pain management with additional education about the disposal of opioids.
15860931|NCT03954951|Other|Multimodality behavioral strategy|"On-line course on hypertension management based on the new ACC/AHA and ESC/ESH guidelines on hypertension management.
~Weekly performance feedback reports: will include percent of patients with uncontrolled hypertension and among this group percent of visits where no change in medication was made. It will also include a comparative assessment of the performance of the physicians compared with their colleagues in the province."
15860932|NCT03954938|Behavioral|Craving Manipulation|Craving will be manipulated based on instructions about cocaine associated images shown to subjects.
15860933|NCT03954938|Drug|Cocaine|The pharmacodynamic effects of cocaine will be determined based on the craving manipulation condition.
15860934|NCT03954938|Drug|Placebo|The pharmacodynamic effects of placebo will be determined based on the craving manipulation condition.
15860935|NCT03954925|Procedure|Anatomic anterior cruciate ligament with short hamstring graft technique|ACL and short hamstring graft
15860936|NCT03954925|Procedure|Anatomic anterior cruciate ligament with a standard hamstring graft technique|ACL with standard hamstring graft
15860937|NCT03954912|Procedure|MAKO assisted unicondylar knee arthroplasty|MAKO assisted
15860938|NCT03954912|Procedure|NAVIO assisted unicondylar knee arthroplasty|NAVIO assisted
15860939|NCT03954899|Dietary Supplement|melatonin|5mg of melatonin-otc 30 minutes before sleep
15860940|NCT03954899|Other|placebo|placebo 30 minutes before sleep
15860941|NCT03954886|Device|Plus powered optical lens|A plus powered optical lens will be placed in front of one eye.
15860942|NCT03954873|Other|Glucagon-like peptide 2|Human glucagon-like peptide 2
15860943|NCT03954873|Other|Saline|Placebo
15860944|NCT03954873|Other|Glucose|20% (w/v) glucose infusion for regulating plasma glucose
15860945|NCT03954873|Other|Insulin|Actrapid (insulin) for lowering plasma glucose
15860946|NCT03954860|Other|Drainage Tube|The drainage tube drainage to guide the pus, blood and liquid accumulated between human tissues or in body cavity outside the body of High tibial osteotomy'patients.
15860947|NCT03954860|Drug|Tranexamic Acid|Tranexamic acid (TXA) is an anti-fibrinolytic drugcan，which can increase the stability of fibrin clots and achieve hemostasis for High tibial osteotomy'patients.
15860948|NCT03954860|Drug|Sodium Chloride 0.9%|Sodium Chloride 0.9% is a solution of sodium chloride, which has the same osmotic pressure as animal or human plasma in physiological experiments or clinics, and can be used to dilute Tranexamic Acid .
15860951|NCT03954821|Device|prefabricated insoles|
15860952|NCT03954808|Other|Motor Imagery Training|Motor imagery training will be designed for the individual basis with standard protocols
15860953|NCT03954808|Other|Traditional physiotherapy|Traditional physiotherapy within a specific program
15860954|NCT03954795|Procedure|TAP|Classic TAP block performed through the petit triangle (the anterior axillary line and iliac crest)
15860955|NCT03954795|Procedure|OSTAP|Modified TAP (OSTAP) block performed from the medial of linea semilunaris applying local anesthetic to the area between xiphoid and anterior iliac crest.
15860958|NCT03954756|Drug|Apatinib and PD1|"Apatinib starting dose of 500mg, qd, oral, taken half an hour after a meal
~PD-1 was administered 200mg (3mg/kg for underweight patients) iv every 2 weeks."
15860959|NCT03954743|Biological|PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine|2 doses administered orally at Day 1 and at Month 1 or Month 2, according to the immunization schedule for RV vaccine administration in participating countries.
15861012|NCT03954327|Drug|Placebo Oral Capsule [CEBOCAP]|Two capsules identical to Raltegravir and one capsule identical to Truvada with no active ingredients by mouth once per day
15860961|NCT03954730|Other|Eccentric Training|First session will be performed 24 hours after pre-training tests i.e. on 4th post- operative day and subsequent sessions will be performed with lapse of 48 hours. During pre-testing, weight for the eccentric training will be determined using Standardized Brzycki formulas for lower limb. Participants will perform one set of 10 repetitions with selected weight. Intensity will be increased every week by decreasing the time of performance. Volume will be increased by increasing one set after two weeks. Eccentric training will be performed in sitting position on dynamic constant external resistance equipment.After session, patient will perform strengthening of quadriceps muscle as per clinical practice guidelines of National Health Service (UK).
15860962|NCT03954730|Other|Active Release Technique|Isometric Quadriceps' contractions against therapist's resistance lasting for 10 seconds will be performed by the patient in inner range of knee extension and after relaxing; actively perform maximum full knee flexion. Patient will perform extension at knee joint again; when reaches the innermost range, therapist will apply pressure on deep fascia either through knuckles/fingers or forearm in the direction towards the hip joint and patient is asked to perform knee flexion simultaneously. The procedure is applied onto vastus lateralis, rectus femoris and vastus intermedialis thrice in a session. After session, patient will perform strengthening of quadriceps muscle as per clinical practice guidelines of National Health Service (UK).
15860963|NCT03954717|Behavioral|Shepherd CAN DO Program|CAN DO Shepherd is a four-day participatory program held at the Shepherd Center, in Atlanta, Georgia or people with MS. The four-day program comprises evidence-based, comprehensive, and personalized educational and experiential opportunities aimed at empowering and enabling a person with MS to live a health life beyond their MS.
15860964|NCT03954704|Drug|GS-1423|Administered intravenously once every 2 weeks
15860965|NCT03954704|Drug|mFOLFOX6 Regimen|Chemotherapy regimen of oxaliplatin, 5-fluorouracil [5-FU], and leucovorin
15860966|NCT03954704|Drug|GS-1423|Administered intravenously
15860967|NCT03954691|Other|brain tumor-immune cells communication|tumoral and immune cell isolation from biopsis
15860968|NCT03954678|Behavioral|Exercise Group|For the first two days after their pre-operative visit, participants will be asked to continue their present level of exercise and activity, which will be monitored by pedometer. Participants will begin the activity intervention on study Day 3. Participants will be instructed to take 10,000 steps per day, recording their daily steps with a pedometer. Participants also will be provided with resistance bands and instructed on how to safely perform 10 whole-body strength training exercises. They will be instructed to perform the exercises once per day, three days a week. Participants will complete the exercise intervention until they have surgery, which is typically 12 to 48 days after the pre-operative visit.
15860969|NCT03954678|Dietary Supplement|Nutrition Group|Participants in the nutrition group will be provided with a liquid over-the-counter nutrition supplement (i.e. Boost or Ensure) to consume. Participants will be instructed to consume 1 bottle, 2 times per day, beginning 5 days before surgery and continuing 5 days post-operatively.
15860970|NCT03954665|Behavioral|10 km time trial|10 km Cycling time trial test will be conducted to examine the effects of the Exogenous Ketone Salts on time
15860971|NCT03954665|Behavioral|30s Wingate|30s all-out test to measure peak power output
15860972|NCT03954665|Dietary Supplement|Ketone|Supplement containing exogenous ketone salts
15860973|NCT03954665|Behavioral|Baseline 10 km time trial|A baseline 10 km Cycling time trial test will be conducted
15860974|NCT03954665|Behavioral|Baseline 30s Wingate|A baseline 30s all-out test to measure peak power output
15860975|NCT03954652|Genetic|WGS-Diagnostic|Blood sampling, shot clinical characterization, WGS-based trio sequencing, NGS analysis and other omics analysis (transcriptomics, proteomics, metabolomics), functional cell biology studies (for example in fibroblast cultures), RNA-seq.
15860976|NCT03954639|Drug|EXPAREL 13.3Mg/mL Suspension for Injection|Combined Sciatic and Adductor Canal Nerve Block with EXPAREL mixed with Bupivacaine (Single Dose)
15860977|NCT03954639|Drug|Bupivacaine Hydrochloride|Combined Sciatic and Adductor Canal Nerve Block with Bupivacaine HCL
15860978|NCT03954626|Biological|brolucuzumab 6 mg IVT|Single intravitreal injection (IVT) of brolucizumab 6 mg
15860979|NCT03954613|Combination Product|Ebicomb|Combination product and combination product plus cognitive exercises will primarily be evaluated in this study
15860980|NCT03954600|Drug|NPT520-34 (125 mg)|NPT520-34, 125 mg oral capsules (size 1)
15860981|NCT03954600|Drug|Placebos (125 mg)|Placebo, 125 mg oral capsules
15860983|NCT03954561|Procedure|endoscopist-administered abdominal compression|The endoscopist administers abdominal compression when loop formation encountered.
15860984|NCT03954561|Procedure|assistant-administered abdominal compression|A assistant administers abdominal compression when loop formation encountered.
15860985|NCT03954548|Device|CB-17-08 CADe|CB-17-08 Augmented Endoscopy System with Computer Aided Detection (CADe) function
15860986|NCT03954535|Behavioral|Free2b|The intervention will consist of a website and 9 sessions. The intervention sessions will facilitate youths' acquisition of personal and social cognitive-behavioral skills. The intervention will focus on goal setting, decision making, enhancing self-worth, coping with stress, combating distorted thinking, communication skills, using alcohol and other drugs and a review session. Each session will require approximately 20 minutes and must be finished in a single sitting. Sessions will be delivered on a weekly basis. The website will include entertainment features and resources.
15860987|NCT03954535|Behavioral|Attention-Placebo|Access to the website with entertainment features and resources - but no session content.
15861013|NCT03954314|Drug|Tranexamic Acid|Tranexamic Acid is a medication used to treat or prevent excessive blood loss from major trauma, post partum, surgery, tooth removal, nose bleeds, and heavy menstruation.
15861014|NCT03954301|Diagnostic Test|Anthropometric measures|Q, valgity angle, subtalar joint, medial longitudinal arch and hallux valgus angles were measured with a goniometer. The height from the ground of the navicula was calculated by caliper, using the Navicular drop test. Metatarsal width was also calculated with this device. Medial longitudinal arch angle, metatarsal width and nacivular drop tests were performed under weight-bearing and non-weight-bearing conditions.
15861015|NCT03954288|Diagnostic Test|serum for sclerostin ELISA test|Blood sample to measure serum sclerostin level
15860988|NCT03954522|Other|interview|"Child = A clinical interview (recorded, duration approximately 30 min) and a scale of acute stress (IES child) will be performed at 2 times (during the 7 days following the first visit of hospitalized kin and 1 month after the kin was discharged from ICU)
~Accompanying parent/kin = Semi-directive interviews (recorded - duration approximately 30 min) will be performed at the same time as those of the child and will be recorded. The parent/kin will also complete a socio-demographic questionnaire of the family group and a depression anxiety scale (HADS)
~Nursing staff = A semi-directive interview (recorded - duration approximately 30 min) will be performed only once (during the 7 days following the first visit to the hospitalized kin). The caregiver will also complete a socio-demographic questionnaire and a Moral Distress Scale (MDS-R)
~Hospitalized parent = One month after ICU discharge, a depression anxiety scale (HADS) and an acute stress scale (IES) will be performed"
15860989|NCT03954496|Device|transcranial direct current stimulation|This is a non-invasive form of stimulation which delivers safe, low levels of electrical current to the brain through the scalp.
15860990|NCT03954496|Behavioral|Intensive upper extremity motor training|This training is administered one-on-one with an occupational therapist. Activities will be focused on skills the participant wants to regain.
15860991|NCT03954483|Drug|Buspirone 10 Mg Oral Tablet|Orally administered prior to experiments.
15860992|NCT03954483|Drug|Triazolam 0.25 MG Oral Tablet|Orally administered prior to experiments.
15860993|NCT03954483|Drug|Placebo oral tablet|Orally administered prior to experiments.
15860994|NCT03954457|Behavioral|A-CWS|The A-CWS intervention is a 15-session culturally-grounded, cognitive-behavioral group intervention designed to develop and enhance African American youths' skills for coping with stress. The intervention structure allows implementation within traditional school and other community settings. The A-CWS uses standard cognitive-behavioral strategies (e.g., relaxation training, cognitive restructuring) to help African American youth identify and cope with individual and contextual stressors, using culturally consistent coping strategies. The intervention emphasizes the identification and management of stressors associated with suicide risk (e.g., racism-related stress, community violence exposure) and the unique experiences of low-resourced, urban African American adolescents (e.g., community violence exposure). The structured, manualized A-CWS curriculum is designed to be sustainable and user-friendly, to ensure that the A-CWS is delivered effectively and with a high degree of fidelity.
15860995|NCT03954457|Behavioral|Standard Care Control|The standard care control condition consisted of standard case management services delivered by the SBHC. Participants randomly assigned to the standard care control condition were referred to the SBHC social worker for case management. Standard care ranged from brief intervention by the SBHC social worker, to more intensive intervention by the SBHC social worker, to outside referral to local community service providers. SBHC social workers determined type and duration of services based on individual participant needs.
15860996|NCT03954444|Drug|Oxymetazoline Hydrochloride|Test Comparator
15860997|NCT03954444|Drug|Rhofade Cream, 1%|Reference Comparator
15860998|NCT03954444|Drug|Placebo|Placebo Comparator
15860999|NCT03954431|Diagnostic Test|Contrast-media enhanced breast CT(CE-BCT)|The breast CT device will take multiple pictures of the subject's breast and create a 3-D image of the breast.
15861000|NCT03954431|Drug|Iodinated Contrast Agent|The CE-BCT diagnostic test will use an iodinated contrast agent. This drug is FDA approved for contrast-enhanced x-ray imaging examinations, though not specifically for dedicated breast computed tomography.
15861001|NCT03954418|Dietary Supplement|Acesulfame K, cyclamate, saccharine, aspartame|Intervention group receives a combination of multiple artificial sweeteners
15861002|NCT03954392|Behavioral|Cognitive behavior therapy with social cognitive training (CBT+SCT)|The cognitive behavioral therapy is based on Beck's cognitive therapy model for the treatment of depression. We will conduct individual therapy based on the Coping with Stress manual used in other depression treatment studies with adolescents. In addition, the investigators will teach the teen explicitly about theory of mind and social perspective taking during each session and we will use examples from their own life to help them learn the skills.
15861003|NCT03954392|Behavioral|CBT-only|The cognitive behavioral therapy is based on Beck's cognitive therapy model for the treatment of depression. The investigators will conduct individual therapy based on the Coping with Stress manual used in other depression treatment studies with adolescents.
15861004|NCT03954379|Drug|Standard of Care (ACB, SA, peri-op pain management)|"INTERVENTION BEFORE SURGERY
~1) Adductor Canal Block will be done using Adductor canal catheter (tube in the thigh) + injection of freezing medication
~INTERVENTION DURING SURGERY
~1) IV propofol for sedation
~INTERVENTION AFTER SURGERY
~1) injection of salty water through the tube in the thigh x 2"
15861005|NCT03954379|Drug|IPACK and multi-modal analgesic regimen|"INTERVENTION BEFORE SURGERY
~Adductor Canal Block will be done using Adductor canal catheter (tube in the thigh) + injection of freezing medication
~iPACK block ( infiltration between Popliteal Artery and posterior Capsule of the Knee) - injection of freezing medication in the back of the knee
~INTERVENTION DURING SURGERY
~IV dexmedetomidine
~IV ketamine Both for sedation
~INTERVENTION AFTER SURGERY
~injection of freezing medication through the tube in the thigh x 2
~IV dexamethasone 8 mg 1 day after surgery"
15861006|NCT03954366|Drug|Rucaparib|Rucaparib 600 mg BID commencing on Day 5 until Day 23.
15861007|NCT03954366|Drug|Rosuvastatin|Single dose of 20mg oral rosuvastatin on Day 1 and Day 19 only.
15861008|NCT03954366|Drug|Oral Contraceptives|Single dose of combined oral contraceptive (30 μg ethinylestradiol and 150 μg levonorgestrel) on Day 1 and Day 19 only.
15861009|NCT03954340|Device|iRemember Neurofeedback (NFB)|"Neurofeedback (NFB) is a treatment technique based on learning with operant conditioning, in which a feedback (or a reward) is given in proportion with the desired physiological activity in order to improve cognition and/or behavior. This research will focus on EEG-NF where electrical activity measured with EEG serves as the physiological activity to be influenced.
~EEG-NFB has been successfully used as a clinical tool for over 40 years treating various disorders from Autism , ADHD , Epilepsy , OCD and depression Electroencephalography (EEG) equipment is used to measure the electrical activity representing the neuronal activity of different parts of the brain.
~During the treatment, electrode(s) are placed in predetermined location. Audio and visual rewards are given when the activity is measured to be within the desired frequency range."
15861010|NCT03954327|Drug|Emtricitabine (FTC)/Tenofovir Disoproxil (TDF)|Emtricitabine (FTC) 200 mg/Tenofovir Disoproxil (TDF) 300 mg by mouth once per day
15861011|NCT03954327|Drug|Raltegravir|Raltegravir (RTF) 600 mg two tablets by mouth once per day
15861018|NCT03954249|Procedure|Erecto Spinae nerve block|The ESPB is a myofascial block alternative to the paravertebral block. It is performed by injecting local anesthetic in the plane between the erector spinae muscle and the spinal transverse process. The ESPB is thought to be safer than the paravertebral block because the transverse process acts as a barrier to the pleura. It has been postulated that local anesthetic spread reaches the paravertebral space and in fact, cadaveric studies have shown dye spreading to involve the ventral and dorsal rami of spinal nerves.
15861019|NCT03954249|Procedure|Multimodal Analgesia|Patients in the control group will receive standard 100mg pregabalin PO, midazolam 2mg IV, fentanyl 100mcg IV.
15861020|NCT03954236|Drug|topical ruxolitinib 1.5% cream|Patients will be prescribed twice daily use of topical ruxolitinib 1.5% cream (randomized half of face/body) to a maximum of 20% BSA on each side for 28 ± 3 days. Topical ruxolitinib will be provided as topical cream. At the end of the 28 ± 3 days study visit, patients will remain blinded to treatment arms. After trial completion (day 28 ± 3 days), all patients will be offered repeated treatment cycle with topical ruxolitinib or standard of care therapy.
15861021|NCT03954236|Other|Topical vehicle/moisturizer cream|Patients will be prescribed twice daily use of vehicle/moisturizer (for contralateral side of face/body) to a maximum of 20% BSA on each side for 28 ± 3 days.At the end of the 28 ± 3 days study visit, patients will remain blinded to treatment arms. After trial completion (day 28 ± 3 days), all patients will be offered repeated treatment cycle with topical ruxolitinib or standard of care therapy.
15861022|NCT03954223|Behavioral|Low sugar and carbohydrate diet|Low sugar and carbohydrate diet (LSC, <90 gm carbohydrate (CHO)/day, <25 gm added sugar/day)
15861023|NCT03954223|Behavioral|Time Limited Eating|16-hour fast/8-hour feed for 3 days per week
15861024|NCT03954223|Device|Continuous Glucose Monitor|CGM (used to monitor adherence and glycemic outcomes without real time feedback)
15861025|NCT03954210|Behavioral|Cognitive Behavioral Therapy for Insomnia (CBT-I)|CBT-I is an in-person, one-on-one program with a graduate psychology research assistant who is trained in providing a standardized CBT-I. Participants will maintain a sleep diary during the course of the program to aid in tailoring the program. Each session will begin with a summary and graphing of sleep diary data and will include an assessment of treatment gains and adherence.
15861026|NCT03954210|Behavioral|Sleep and Lifestyle Education|Participants in the sleep and lifestyle education group will attend six weekly, in-person, one-on-one, stretching, and thinking activity sessions with a graduate research assistant to control for socialization and contact with research personnel.
15861027|NCT03954197|Other|No hormone|No hormonal injection before oocytes retrieval
15861028|NCT03954197|Other|hCG|a subcutaneous injection of hCG (Choriogonadotropin alpha, Ovitrelle®, Merck Serono, 250 µg) is performed 36 hours before oocytes retrieval
15861029|NCT03954197|Other|GnRH a|a subcutaneous injection of GnRH agonist (triptorelin, Decapeptyl, Ipsen, 0,2 mg) is performed 36 hours before oocytes retrieval
15861030|NCT03954184|Behavioral|NIATx-TI with Product Training/On-line Support|NIATx-TI framework includes the product training as well as a preimplementation phase and a post-implementation phase. A NIATx-TI coach will provide the training for this arm. The coach will also assist the organizations with applying the NIATx-TI framework.
15861031|NCT03954171|Other|Patients treated with platinum based-chemotherapy|"Blood samples, tumor biopsy specimens and ascites samples will be collected at different time points (if feasible, according to the samples taken in the standard practice):
~before treatment initiation (blood sample),
~during hospitalisation for surgery (blood sample),
~during follow-up consultations (blood sample).
~If tumor biopsy and/or ascites sampling are performed during the standard care, a sample will be collected for the study."
15861032|NCT03954158|Drug|Crisaborole ointment 2%|BID regimen
15861033|NCT03954158|Drug|Vehicle|BID regimen
15861034|NCT03954158|Drug|Crisaborole ointment 2%|QD regimen
15861035|NCT03954158|Drug|Vehicle|QD regimen
15861036|NCT03954145|Procedure|Enamel pumicing before bonding the lingual retainer.|"Lingual surfaces of the lower incisors and canines are pumiced before bonding the lingual retainer.
~Teeth are being cleaned using a brush loaded with pumice and mounted on a low speed contra-angle. Teeth are then etched and the multi-braided retainer wire is being bonded with composite onto the lingual surfaces of the lower canines and incisors."
15861037|NCT03954145|Procedure|Enamel sandblasting before bonding the lingual retainer.|"Enamel is being initially prepared through sandblasting the lingual surfaces of the mandibular canines and incisors.
~Sandblasting is performed with the help of a MicroEtcher IIATM (Danville) which is projecting 50 μm Al2O3 particles onto the enamel surfaces. Teeth are subsequently etched and the retainer is then being bonded with composite onto the lingual surfaces of the mandibular incisors and canines."
15861040|NCT03954106|Drug|Defibrotide|Once daily on CAR-T Day -5, -4, -3 before lymphodepletion and also every 6 hours daily on CAR-T Day 0-7.
15861041|NCT03954093|Device|Transcranial direct current stimulation|tDCS produces hyper/hypopolarizing potentials in the cortex underlying the scalp electrodes and can increase/decrease the excitability of targeted brain regions.
15861042|NCT03954080|Device|Intraspinal-optimal stim therapy|During the trial, percutaneous lead(s) will be implanted, following standard clinical practices, in the posterior epidural space with the final lead position located in the optimal area to provide pain relief by stimulating neural tissue in order to create paresthesia(s) only on the painful dermatome(s). During Intraspinal-Optimal Stim, a set of electrodes in the stimulation lead(s) will deliver a charge-balanced, pulsed electrical signal with stimulation parameters (frequency, pulse width, and amplitude) within the FDA approved specifications of the commercially available external neurostimulator. These will be adjusted to produce paresthesia coverage of the painful area. Patients that will report equal or greater than 50% reduction in pain, relative to baseline pain, may undergo permanent implantation of a commercially available neurostimulator (INS). This will require a surgical intervention to implant stimulation leads, INS and anchoring hardware followed by therapy programming.
15861209|NCT03952637|Diagnostic Test|Electrocardiogram (EKG)|Performed as part of screening and for safety before sedated procedures. The ECG will take approximately 10 minutes and may be limited due to the subject s cooperation.
15861044|NCT03954054|Behavioral|"Choizitaconso - therapeutic patient education programme"|"Choizitaconso is a therapeutic patient education programme that teaches psychosocial skills to people with alcohol use disorder (PWAUD), to help them (re)establish controlled drinking and reduce harms.
~It lasts for 10 weeks for each participant and consists of the following 5 modules, including one optional module focusing on the family environment:
~Understand the mechanisms that trigger and/or maintain alcohol-related difficulties
~Plan and evaluate personalized controlled drinking strategies
~Understand and identify external and internal influences (e.g., thoughts and emotions), identify and manage risk situations
~Identify alcohol effects and alcohol-related expectations (by developing self-observation skills)
~Family environment: learning how to evaluate and take care of oneself (e.g., how to express feelings)
~Each module consists of 2 to 4 collective workshops that each last 120 minutes and involve 5 to 10 persons."
15861045|NCT03954041|Drug|BIIB093|Administered as specified in the treatment arm.
15861046|NCT03954041|Drug|Placebo|Administered as specified in the treatment arm.
15861047|NCT03954028|Procedure|Gingival Punch Biopsy after healing of Gingival Soft Tissue Augmentation|Patients needing gingival soft tissue augmentation will receive two kinds of gingival tissue graft material in a split-mouth design. The autogenous connective tissue (CTG) graft material will be randomized to apply to one half, and commercial acellular dermal matrix (ADM) materials will be used in the opposite half. After 3 months of healing, a gingival punch biopsy will be performed in both sides to collect the tissues for analysis.
15861048|NCT03954015|Diagnostic Test|Contrast Enhanced imaging|Contrast Enhanced Ultrasound (CEUS) with US Microvessel Imaging, Contrast Enhanced Dual Energy Mammography (CEDM) and Contrast Enhanced Breast MR (CEMR): Comparison of Three Methods for Early Detection of Breast Cancer.
15861049|NCT03954015|Drug|Lumason|FDA approved and used routinely for ultrasound exams of the heart and liver as well as the urinary tract in children. It contains microbubbles that are small enough to pass through the blood stream.
15861051|NCT03953989|Drug|Ranolazine PR (prolonged-release) 500 mg 1 tablet bis in die and 750 mg 1 tablet bis in die|Patients enrolled in the study, at the end of the titration phase will be treated with ranolazine 750 mg or 500 mg, 1 oral tablet twice a day for 4 months on top of standard of care treatment
15861053|NCT03953963|Device|HydraSolve T2D™|The HydraSolve T2D™ System will be used to perform the combined minimally invasive laparoscopic and mini-laparotomy procedure to selectively extract excess intra-abdominal fat from the mesentery. All patients will receive standard nutritional counseling and their medications will be adjusted to achieve target levels of blood glucose control.
15861054|NCT03953950|Drug|Spironolactone|Spironolactone Starting dose: 25 mg/day Target dose: 100 mg/day Titration: every 1-2 weeks, based on BP (keep< 140/90 mmHg, but avoid hypotension <90/60 mmHg), and serum potassium level (<5.5 milliequivalent /liter)
15861055|NCT03953950|Drug|Losartan|Losartan Starting dose: 50 mg/day Target dose: 100 mg/day Titration: every 1-2 weeks, based on BP (keep< 140/90 mmHg, but avoid hypotension <90/60 mmHg), and serum potassium level (<5.5 milliequivalent /liter)
15861056|NCT03953924|Other|Transtheoretical model-based (TTM - based) intervention and motivational interviewing (MI)|The MI was implemented 2 times, 20 minutes each time, the trained nurse interviewed each patient face-to-face by bedside. Based on the evaluation results and motivational interviewing, the change stages of the patients' behavior changes were identified. According to the changing stage,TTM - based intervention was given 3 times in the form of a small course, 20 minutes each time, the key point was divided into three stages.
15861057|NCT03953911|Biological|Mobile Clinic|This intervention involves the availability of a free mobile clinic operated by Cedar-Sinai Medical Center providing free HPV vaccinations at school campuses.
15861058|NCT03953911|Behavioral|Educational Sessions for Parents|This intervention involves providing free weekly educational sessions for parents of students at the participant schools pertaining to the HPV Vaccination.
15861060|NCT03953885|Other|Fire needle|"Participants wear eye masks and fully expose the lesions. After selecting the acupuncture points, the surgeon routinely disinfects the hands of the operator and the acupuncture points of the participants before the operation. After selecting an acupuncture needle with a specification of 0.4*40mm and ignites the alcohol lamp, the operator continuously moves the needle from the needle root to the needle tip to burn the red needle to disinfect the needle in the outer flame of the alcohol lamp.
~The operator ignites the alcohol lamp, and burns the needle tip and the needle body to the outer flame of the alcohol lamp until it is completely red (the length of the needle burning red is determined by the acupuncture depth), and then rapidly penetrates the skin lesion vertically, the depth of the acupuncture is based on the thickness of the skin lesion, when the operation is performed, the outer edge of the lesion is punctured to the center point, and the spacing is 0.3 to 0.5 cm."
15861061|NCT03953885|Other|Fire needle Placebo|"Participants wear eye masks and fully expose the lesions (no lesions on the head and face, external genitalia and skin folds). After selecting the acupuncture points, the surgeon routinely disinfects the hands of the operator and the acupuncture points of the participants before the operation, then selects an acupuncture needle with a specification of 0.4*40mm to prepare for operation.
~The operator rapidly penetrates the skin lesion vertically, the depth of the acupuncture is based on the thickness of the skin lesion, when the operation is performed, the outer edge of the lesion is punctured to the center point, and the spacing is 0.3 to 0.5 cm."
15861062|NCT03953859|Genetic|double strand break|an induction of a double strand break will be made in the embryos generated for this research and the repair mechanism observed
15861210|NCT03952637|Diagnostic Test|Echocardiogram|Performed as part of screening. The Echo will be done in the Echo Lab and may take approximately 20-30 minutes. The exam may be limited due to the subject s cooperation level.
15878293|NCT03817931|Drug|Anticholinergic|Tablet taken once daily.
15861063|NCT03953833|Biological|Recombinant anti-HER2 humanized monoclonal antibody conjugate for injection.R&D code: B003.|"Usage: Intravenous infusion; Dose escalation stage: doses 0.6, 1.2, 2.4, 3.6, 4.8 mg / kg, 1-6subjects each. Dose expansion stage: 20 subjects are enrolled and take the recommended dose based on the result of dose escalation stage.
~Infusion time：90 minutes(90min-106min suggested) for the first time; if no infusion reaction happens, the follow-up time is adjusted to at least30 minutes(30min-40min suggested).Dose escalation stage: treatment cycle is administered every 21days,the infusion is taken at the first day of each treatment cycle.Observation period of DLT is the 21st day of the first treatment cycle."
15861064|NCT03953820|Drug|Diazepam Buccal Film|Diazepam Buccal Film administered on inner aspect of the cheek at the recommended dose regimen (10 mg to 17.5 mg according to body weight) following ingestion of a moderate fat meal and following ingestion of a high-fat meal.
15861065|NCT03953820|Drug|Diastat® Rectal Gel (Valeant Pharmaceuticals USA)|Diastat Rectal Gel administered rectally according to product label administration and dosing instructions (10 mg to 20 mg according to body weight) following ingestion of a moderate-fat meal.
15861066|NCT03953807|Drug|Dexamethasone Intravitreal Implant|Implant 700 μg
15861067|NCT03953794|Device|Fitbit Charge 3|Smart watch monitoring activity and movement, heart rate, sleep, and more
15861068|NCT03953781|Drug|Effect of valporate on Reproductive Functions in Newly Diagnosed Epileptic Males|
15861069|NCT03953781|Drug|Effect of levetiracetam on epileptic males reproductive function|
15861070|NCT03953768|Device|Vagal nerve stimulation (VNS)|Implantation with vagal nerve stimulator for epilepsy
15861071|NCT03953755|Procedure|Tricuspid valve repair|Tricuspid valve repair
15861072|NCT03953742|Drug|CPI-200|CPI-200 will be administered via intravenous infusion on Day 1 of a 21-Day cycle
15861073|NCT03953729|Drug|Ibuprofen|"The child and his / her guardian shall immediately upon arrival for informed about the participation in the research, being evaluated on the criteria of inclusion and exclusion described above. Soon after the signature by the responsible for the child of the Informed Consent Form (Appendix A), the drug shall be administered at the dosage established by Clark's formula, according to the weight of each child. It will then be evaluated the degree of anxiety of the child in front of the dental treatment using the scale Children's Fear Survey Schedule-Dental Subscale (Barberio, 2017). After 30 minutes of drug administration, treatment will start."
15861074|NCT03953729|Drug|Placebo|"The child and his / her guardian shall immediately upon arrival for informed about the participation in the research, being evaluated on the criteria of inclusion and exclusion described above. Soon after the signature by the responsible for the child of the Informed Consent Form (Appendix A), the placebo shall be administered at the dosage established by Clark's formula, according to the weight of each child. It will then be evaluated the degree of anxiety of the child in front of the dental treatment using the scale Children's Fear Survey Schedule-Dental Subscale (Barberio, 2017). After 30 minutes of drug administration, treatment will start."
15861075|NCT03953716|Device|low level light therapy|Start using low level light therapy after the menstrual period, once a day, every 20 minutes * 5 days ( one treatment cycle), start the next course at intervals of 2 days until the next menstruation
15861076|NCT03953716|Drug|DING KUN DAN|DING KUN DAN,3.5g BID for 10 days (starting 3-5 days before menstruation) *3 menstrual cycle
15861077|NCT03953716|Drug|Simulated drug of DING KUN DAN|Simulated drug of DING KUN DAN，3.5g BID for 10 days (starting 3-5 days before menstruation) *3 menstrual cycle
15861078|NCT03953716|Drug|Marvelon|Marvelon 1 pill QD*21 days (starting on the 5th day of menstruation, continuing the next cycle after 1 week of withdrawal) *3 menstrual cycle
15861079|NCT03953703|Drug|Levocarnitine|Levocarnitine 990mg twice per day for 4 weeks
15861080|NCT03953703|Drug|Placebo|Placebo 990mg twice per day for 4 weeks
15861081|NCT03953690|Other|use of e-Health service|use of the e-Health e-Lupus account (at least) once a month and encouraged to advise his doctor to consult the entered data before the following consultation
15861082|NCT03953677|Drug|Dexmedetomidine 100 Mcg/mL Intravenous Solution|Continuous infusion of dexmedetomidine at 0.7 µg/kg/h for 2 hours and then 1 µg/kg/h at fixed dose
15861083|NCT03953677|Drug|5% glucose Infusion solution|Continuous infusion of placebo (5% glucose) at 0.7 µg/kg/h for 2 hours and then 1 µg/kg/h at fixed dose
15861084|NCT03953664|Other|Experimental-Exercise training|Each session lass 60 minutes, during which time 20 minutes are allocated for warming up and cooling down (stretching) and 40 minutes are allocated to strength or/and aerobic training exercises.
15861085|NCT03953651|Other|Follow-up|Onset of Major Adverse Cardiovascular Event of death from all causes will be collected at 3 and 6 months after inclusion.
15861086|NCT03953638|Diagnostic Test|Next Generation Sequencing|To provide rapid etiological diagnosis of patients by means of next-generation sequencing.
15861087|NCT03953625|Other|delivery of the low back pain booklet|"When a patient arrives at the GHPSJ emergency room or in general medical consultation at the CMT and a diagnosis of common acute low back pain is made, the physician verifies the study selection criteria.
~If it is randomized in the arm 2 with booklet group, the management will be the same as for the without booklet group but with the hand delivery of the booklet in addition.
~All patients will be informed about the existence of the booklet. A link to the digital version on the ameli.fr website is included in the information note The patient will be contacted 3 months later by a Clinical Research Associate (CRA) to conduct a data collection."
15861088|NCT03953612|Drug|PREG 300/500 mg|2 doses of PREG (300/500 mg/day)
15861089|NCT03953612|Drug|Placebos|placebo
15861090|NCT03953599|Biological|CD19-STAR-T cells|CD19-STAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of STAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for 2 days before infusion.
15861091|NCT03953586|Diagnostic Test|Bubble suction test and tubal peristalsis|Efficacy of this test in cases of hydrosalpnix (group A) and normal tubes (group B)
15861092|NCT03953573|Other|Survey|Survey completed at 1 day, 8 days 1 or 3 months post delivery
15861267|NCT03952338|Other|Food coupons|Participants will receive 16 coupon sheets (each sheet contains $21 in coupons) over 10-15 weeks (households with 5-8 individuals will receive 32 coupon sheets) to purchase fruits, vegetables, dairy, meat/poultry/fish, eggs, nuts, and cut herbs at participating BC farmers' markets.
15861311|NCT03952065|Drug|PD1/PDL1 inhibitor|Infusion of PD1/PDL1 inhibitor through peripheral vein or neck artery.
15861093|NCT03953560|Diagnostic Test|dyspnea grade ≥ II according NYHA-WHO|"Intervention Investigator from each center will recover consecutives PE patients and collect baseline, demographic and comorbidities.
~In all patients enrolled in the study a short questionnaire regarding dyspnea symptoms will be performed. All patients that refer dyspnea grade ≥ II according NYHA-WHO (6) modified scale will be cited as outpatient to be evaluated
~Imaging studies and right heart catheterization is the procedure agreeing with the standard care according to current ESC/ERS Guidelines.
~In all patients, the following tests will be performed:
~Pulsioximetry.
~Electrocardiogram.
~Blood sample with determination of NT-ProBNP.
~Echocardiography. Only an echocardiography indicative of PH warrants further evaluation
~V/Q scintigraphy. Possible CTEPH can be assumed when mismatched perfusion defects are detected by VQ scan.
~Right heart catheterization & Pulmonary CT Scan are required for confirming the diagnosis"
15861094|NCT03953521|Device|intermittent Theta burst stimulation|Stimulation of the left dorsolateral prefrontal Cortex with a specific repetitive transcranial magnetic Stimulation protocol (intermittent Theta burst Stimulation) according to Blumberger et al., 2018, Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692.
15861095|NCT03953508|Other|Cigarette flavor type|Participants will smoke several puffs (each) of a menthol Camel Crush and several puffs of a non-menthol Camel Crush cigarette.
15861096|NCT03953495|Behavioral|Better Together|The Better Together Intervention consists of a 7 self-paced online relationship education modules. Following an introductory and overview module couples will complete each of the following together on their web-connected device (computer, ipad, phone). Each module includes didactic material, demonstration vignettes, and guided discussions or skills building exercises. Module 1 focuses on identifying individual and relationship strengths; Module 2 focuses on destructive communication patterns, Module 3 focuses on positive communication skills; Module 4 teaches a problem-solving technique; Module 5 focuses on stress and coping; Module 6 focuses on relationship expectations and commitment, and Module 7 provides a summary of the program. Each module takes approximately 30 minutes to an hour to complete. Metrics will be assessed at baseline, post-intervention, and at a 3 month follow up.
15861097|NCT03953469|Dietary Supplement|Passiflora incarnata|One-time administration of 1/8 tsp solid extract Passiflora incarnata providing 900mg of Passiflora incarnata
15861098|NCT03953456|Drug|elafibranor 120mg|elafibranor 120mg is a coated tablet for oral administration, once daily
15861099|NCT03953456|Drug|Placebo|Placebo is a coated tablet for oral administration, once daily
15861100|NCT03953443|Other|Not interventional|
15861101|NCT03953430|Other|Gait analysis|
15861102|NCT03953417|Device|Bilateral accelerated intermittent theta-burst treatment|"All participants will receive bilateral accelerated intermittent theta-burst stimulation to the left and right DLPFC. Treatment will be targeted by utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of resting motor threshold adjust to the skull to cortical surface distance.
~Stimulation will be delivered to left and right-DLPFC using the MagPRo stimulator."
15861103|NCT03953404|Diagnostic Test|SPLA2-IIA|bedside blood test
15861104|NCT03953391|Other|Tea|Subjects walk to a nearby area and prepare a cup of 150 ml tea once every hour. The tea is consumed whilst being seated at their desks.
15861105|NCT03953391|Other|Water|150 ml water is served to subjects once every hour. The water is consumed whilst being seated at their desks.
15861106|NCT03953378|Other|Multi-parametric Flow Cytometry analysis on patients and healthy donors samples|"Collection of venous blood (16 mL) and synovial fluid (when available) samples, for each patient, at inclusion and in the frame of the usual medical follow-up at 3 months and between 6 and 12 months, before the onset of MTX (untreated patients) or during the course of MTX treatment (MTX-treated patients).
~Collection of anonymous healthy donors blood samples, age- and sex-matched, obtained from the Etablissement Français du Sang.
~Multi-parametric Flow Cytometry analysis was performed on these samples to assess CD73 expression on total memory T cells and within T helper lymphocyte subsets, their cytokine production and AMPase functions. For FoxP3 intracellular staining, cells were treated using the FoxP3 Fixation and Permeabilization kit (Life Technologies), according to manufacturer instructions. Stainings were analyzed on a LSR-Fortessa™ (BD Biosciences) with conserved settings throughout the entire study and data were analyzed using FlowJo™ Software (Tree Star v10.4)."
15861107|NCT03953365|Procedure|Prophylactic Mesh|Prophylactic Mesh after closure of the abdominal wall after Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
15861108|NCT03953352|Other|Helical intensity-modulated radiotherapy (IMRT)|Helical intensity-modulated radiotherapy (35 fractions, 5 fractions per week) will be administered during 7 weeks: 2 Gy per fraction on tumor and 1.6 Gy per fraction on bilateral lymph node areas.
15861109|NCT03953339|Procedure|Release or no release of the suprascapular nerve|
15861110|NCT03953326|Behavioral|HeartPhone app|Evaluative conditioning (temporally distributed micro-doses presented upon activation of smartphone screen)
15861111|NCT03953326|Drug|Acetylcholine|Endothelium-dependent vasodilation is tested with the localized delivery of the neurotransmitter
15861112|NCT03953326|Drug|Sodium Nitroprusside|Endothelium-independent vasodilation is tested with the localized delivery of the nitric oxide donor
15861113|NCT03953326|Drug|L-Arginine, N2-((4-Methylphenyl)Sulfonyl)-, Methyl Ester|This nitric oxide inhibitor is continuously given during the localized delivery of the endothelium-dependent agonist acetycholine.
15861114|NCT03953300|Biological|Benralizumab|Benralizumab: 30 mg/mL solution for injection in accessorized prefilled syringe (APFS) will be administered subcutaneously (SC) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks - Weeks 16, 24, 32, 40.
15861115|NCT03953300|Biological|Placebo|Matching placebo will be administered subcutaneously with accessorized prefilled syringe (APFS) every 4 weeks for the first 3 doses - Weeks 0, 4 and 8, and then every 8 weeks - Weeks 16, 24, 32, 40.
15861116|NCT03953287|Drug|Paracetamol|A randomized, cross over design
15861117|NCT03953261|Drug|Curcumin supplement|Intervention is 2 grams of curcumin supplement per day
15861118|NCT03953248|Drug|L-Carnitine|
15861119|NCT03953235|Biological|GRT-C903|a shared neoantigen cancer vaccine prime
15861120|NCT03953235|Biological|GRT-R904|a shared neoantigen cancer vaccine boost
15861121|NCT03953235|Biological|nivolumab|anti-PD-1 monoclonal antibody
15861122|NCT03953235|Biological|ipilimumab|anti-CTLA-4 monoclonal antibody
15861123|NCT03953222|Device|Wearable real-time feedback device|The proposed wearable device can provide real-time feedback of primary gait and posture measures through auditory feedback. The feasibility of people with Parkinson's disease (PD) to utilize to feedback to modulate and improve their gait and posture will be investigated. Two types of feedback will be studied: (a) continuous feedback involving sonification of movements to facilitate learning proper movements (such as to take big steps, swing arms, rhythmic walking, maintain upright posture, etc.) and (b) on-demand feedback where the feedback is provided only if necessary to reduce overload of information and prevent developing dependency on the system.
15861124|NCT03953209|Drug|Spironolactone 50Mg Tablet|Oral administration of one spironolactone 50 mg tablet once daily for 12 weeks
15861125|NCT03953209|Drug|Spironolactone 100Mg Tablet|Oral administration of one spironolactone 100 mg tablet once daily for 12 weeks
15861126|NCT03953209|Drug|Spironolactone 200Mg|Oral administration of two spironolactone 100 mg tablets once daily for 12 weeks
15861127|NCT03953196|Biological|Imvanex|Imvanex 0.5 milliliter (mL) suspension for injection will be administered as single subcutaneous (SC) injection.
15861128|NCT03953196|Biological|Shingrix|Shingrix 0.5 mL suspension will be administered as single intramuscular (IM) injection.
15861129|NCT03953196|Biological|LPS|LPS 1.0 nanogram per kilogram (ng/kg) endotoxin suspension will be administered as single IV injection.
15861130|NCT03953196|Biological|Candin|Candin 0.1 mL solution for injection will be administered as one intradermal injection.
15861131|NCT03953196|Other|Skin Biopsy|3 punch biopsies will be performed and lower abdomen tissue biopsy specimens will be collected on Day 1.
15861132|NCT03953196|Other|Saline Control|Saline control solution for injection will be administered as one intradermal injection.
15861133|NCT03953183|Other|P3P-1mg|P3P-1mg (P3P product containing 1mg of nicotine.)
15861134|NCT03953183|Other|P3P-2mg|P3P-2mg (P3P product containing 2mg of nicotine.)
15861135|NCT03953170|Drug|Teduglutide|"Teduglutide (Gattex, Shire) was approved by the FDA in 2012 for use in adult patients with short bowel syndrome requiring parenteral support only.
~The results of this study will not be used to justify a change of indication, or dose currently approved for Teduglutide, and will not be used to advertise the drug. This study meets all of the requirements for exemption from the IND regulations and an IND exemption has been confirmed by the FDA."
15861136|NCT03953170|Drug|Placebo|Placebo
15861137|NCT03953157|Dietary Supplement|Dietary Intervention|Receive dietary intervention
15861138|NCT03953157|Behavioral|Exercise Intervention|Receive exercise intervention
15861139|NCT03953157|Other|Questionnaire Administration|Ancillary studies
15861140|NCT03953144|Device|VisiblePatient™ 3D Lung Modelling|The 3D virtual models provided by Visible Patient™ will be made by experts in medical image analysis using the high-resolution CT scans. Patients will have 3D virtual reconstructions of their pulmonary anatomy with the target lesion created pre-operatively.
15861141|NCT03953144|Drug|IC-Green (ICG)|ICG will be prepared as a sterile solution (2.5 mg/10mL) for injection. After vascular ligation, a 6 to 8mL bolus of ICG solution will be injected into the peripheral vein catheter, followed by a 10mL saline solution bolus. The Firefly camera will then be used for the NIF imaging. It is expected that the entire lung, except the segment which was previously isolated from blood supply, will fluoresce within 30-40 seconds, exhibiting a green hue. The surgeon will perform the pulmonary resection and the resected 'dark' lung segment will be immediately evaluated by a pathologist, depending on the pathologist findings the operation may be concluded or the patient will receive a pulmonary lobectomy.
15861142|NCT03953131|Procedure|Computed Tomography|Undergo PET/CT
15861143|NCT03953131|Radiation|Gallium Ga 68-DOTATATE|Given IV
15861144|NCT03953131|Procedure|Positron Emission Tomography|Undergo PET/CT
15861145|NCT03953118|Drug|Azithromycin Oral Product|Oral azithromycin dosed at 1 gram per week for 3 weeks
15861146|NCT03953118|Drug|Placebo Oral|Oral placebo tablet
15861147|NCT03953105|Device|ePER|usind the ePER for weight estimation and suggestion of the defined parameter
15861148|NCT03953105|Device|BT|usind the BT for weight estimation and suggestion of the defined parameter
15861149|NCT03953092|Drug|YG1699|YG1699 at Multiple Doses
15861150|NCT03953092|Drug|Placebos|Placebos
15861151|NCT03953079|Drug|Drug: GB-102|Intravitreal injection of GB-102
15861152|NCT03953079|Drug|Aflibercept|Intravitreal injection of aflibercept (2 mg dose)
15861153|NCT03953066|Other|The calculation of blood IL-6 and coloctral milk melatonin|Collected maternal colostral milk will be sampled for melatonin levels.Blood samples driven before and after delivery will be evaluated for IL-6 levels in each group
15861154|NCT03953053|Device|Femtosecond Laser Assissted Cataract Surgery|During routine Catarct Surgery the Femtolaser cuts a ACCC (Anterior Continous Curvilinear Capsulotomy) into the lensbag and fragmentise the cataract affilited lens body
15861155|NCT03953040|Diagnostic Test|intracoronary imaging (IVUS, OCT)|Patients presenting with non STE-ACS will be subjected after performing PCI of the culprit lesion to intracoronary imaging with the help of IVUS and OCT of the non-culprit lesions to detect and image the so-called vulnerable plaques
15861156|NCT03953027|Other|Survey Administration|Ancillary studies
15861157|NCT03953001|Device|Adminstration Technique using Buzzy external distractor|External application of Buzzy distractor during administration of dental anesthetic
15861158|NCT03953001|Drug|2% Lidocaine with 1:50,000 epinephrine|Local Dental anesthetic infiltration
15861159|NCT03953001|Drug|Topical Anesthetic|20% Benzocaine gel was applied on the area of infiltration
15861160|NCT03952988|Dietary Supplement|Probiotic ice cream|One portion (50g) of an ice-cream containing the probiotic B. bifidum 900791 (>10(exp7)/g) every day for 4 weeks
15861161|NCT03952988|Dietary Supplement|Placebo ice cream|One portion (50g) of an ice-cream without probiotic every day for 4 weeks
15861211|NCT03952637|Other|Electroencephalogram (EEG) awake andextended overnight|Completed at baseline. The subject will also have an EEG if clinically indicated (for example encephalopathy, seizures, or other change in neurological status or if changes on the previous study are deemed to warrant a follow up study) during post treatment follow up. The procedures will be conducted in the Neurology Testing Department. The total time for an awake EEG, including lead placement, is approximately 40 minutes. An extended overnight EEG will take approximately 12 hours. The exam may be limited due to the subject s cooperation level.
15878651|NCT03815240|Other|No dressing|no dressing at sacrum
15861162|NCT03952975|Other|Vaginal bleeding|Vaginal bleeding was classified into four categories according to the timing. Intraoperative bleeding (defined as bleeding that occur during the LEEP procedure), early postoperative bleeding (defined as bleeding that occur between end of the LEEP procedure and home discard), late postoperative bleeding (defined as bleeding that occur within two weeks after the home discard, and required hemostatic interventions such as electrocauterization, gauze packing, or cervical suturing, excluding menstrual bleeding), and persistent postoperative bleeding (defined as vaginal bleeding that occurs more than 2 weeks after the procedure with or without required hemostatic interventions, excluding menstrual bleeding).
15861163|NCT03952962|Device|Abbott Laboratories Infinity™ implantable deep brain stimulation system|Deep brain stimulation (DBS) refers to the process of delivering an electrical current to a precise location in the brain.
15861164|NCT03952949|Behavioral|Default Option While Online Grocery Shopping|"The default option is a behavioral economics construct that refers to the option a consumer selects if no active choice is made (e.g. opt-out 401K plans, which significantly increase enrollment, compared to active sign up). Participants in the default condition were presented with a prefilled online shopping cart containing groceries that met nutritional requirements based on participants' gender and age."
15861165|NCT03952949|Behavioral|Nutrition Education|"The nutrition education materials were adapted from materials currently utilized by the New York State Office of Temporary and Disability Assistance (Eat Smart New York)."
15861166|NCT03952936|Other|Vestibular Rehabilitation|standard vestibular rehabilitation with gaze stability, balance training, habituation tailored to the subject
15861167|NCT03952923|Biological|CD19-CAR-T cells|CD19-CAR-T cells are prepared via lentiviral infection. 5 days prior to infusion of CAR-T cells, subjects receive fludarabine at dose 30mg/m2/day and cyclophosphamide treatment at dose 250mg/m2 for 3 days and take a rest for 2 days before infusion.
15861168|NCT03952910|Other|Online pain education program|Online pain education program
15861169|NCT03952897|Other|balneotherapy|10 days of balneotherapy with immersion techniques using Fitero spa water.
15861170|NCT03952884|Behavioral|Resistance Exercise|Prior to protein consumption participants will perform an acute bout of resistance exercise. They will warm up with two sets of 10 repetitions at 35-75% working load respectively, then perform four working sets of 10-12 repetitions at 65-70% of 1-RM. 1 min, 30 sec rest periods will be implemented between each set.
15861171|NCT03952884|Behavioral|No Resistance Exercise|Participants allocated to this group will not perform exercise prior to the administration of the nutritional intervention. Participants will remain at rest throughout the trial.
15861172|NCT03952884|Dietary Supplement|Leucine|Participants will be given 2g of leucine dissolved in 250mL of water. Drink will be consumed immediately after exercise or equivalent time point for non-exercise group.
15861173|NCT03952884|Dietary Supplement|Dileucine|Participants will be given 2g of dileucine dissolved in 250mL of water. Drink will be consumed immediately after exercise or equivalent time point for non-exercise group.
15861174|NCT03952858|Other|Telerehabilitation Group|The telerehabilitation Group receives physiotherapy supervised exercises on-line. The Community Center Group receives the traditionel training offer in the municipality Center for older people.
15861175|NCT03952845|Other|Capsaicinoid|This is a tolerability study on doses lower than previously published for the use of intranasal capsaicinoid in the treatment of rhinitis
15861176|NCT03952832|Drug|Leflunomide|Given PO
15861177|NCT03952832|Other|Quality-of-Life Assessment|Ancillary studies
15861178|NCT03952832|Other|Questionnaire Administration|Ancillary studies
15861179|NCT03952819|Diagnostic Test|serum sclerostin|blood samples obtained
15861180|NCT03952806|Drug|Verdiperstat|300mg 2 -oral- capsules, BID
15861181|NCT03952806|Drug|Placebo|Matching placebo
15861182|NCT03952793|Other|extended biopsy|Additional sample are performed during a biopsy to provide tumor tissues for the organoid technique development
15861184|NCT03952754|Behavioral|Hip Hop Nutrition-Math Curriculum|This program teaches children skills needed to understand restaurant-menu boards, how to make healthy food choices, while reinforcing the common core math concepts they are learning in school. The program consists of: 2 lessons a week, of about 1 hour each lesson, for a total of 20 lessons.
15861185|NCT03952754|Behavioral|Food Explorers Program|"After-school program Food Explorers will represent Usual Care. This program comprises food and exploration activities, familiarizing children with diverse foods, nutrition concepts, tasty recipes and physical activity."
15861186|NCT03952741|Behavioral|Physical Therapy|
15861187|NCT03952728|Behavioral|Intensive lifestyle intervention|Lifestyle intervention focused on weight loss through diet and physical activity
15861188|NCT03952728|Behavioral|Diabetes support and education|Behavioral intervention focused on diabetes support and education
15861189|NCT03952715|Drug|Ibuprofen 400 mg|Each subject will receive Ibuprofen once, in between two psycho-physical assessments. Between the drug intake and the second assessment the subject will have to wait for 40 minutes.
15861190|NCT03952715|Drug|Placebo oral tablet|Each subject will receive Placebo (sugar pill) once, in between two psycho-physical assessments. Between the placebo pill intake and the second assessment the subject will have to wait for 40 minutes.
15861191|NCT03952702|Procedure|Myopic overcorrection|Myopic overcorrection
15861192|NCT03952689|Device|Serenno Medical Automatic Urine Output measuring device|"Device that measures ongoing urine output will be connecter to the patients catheter. The urine count of the device will be compared to the gold standard measurement technique (nurse count)."
15861212|NCT03952637|Diagnostic Test|Laboratory tests|Performed on blood and urine include safety labs, clinically indicated labs and research collections. Additional specimens may be collected for the PI s biorepository or as clinically indicated. Blood volumes for clinical diagnostic testing and research will be consistent with Clinical Center laboratory guidelines.
15861268|NCT03952338|Other|Nutrition skill-building|Participants will be invited to participate in nutrition skill-building activities throughout the intervention period. To be consistent with the real-world program, the frequency and types of skill-building activities offered will vary by community partner, and participation is not required.
15861269|NCT03952325|Drug|Tesetaxel|Tesetaxel at 27 mg/m2 orally Q3W
15861270|NCT03952325|Drug|Tesetaxel|Tesetaxel at 27 mg/m2 orally Q3W
15861193|NCT03952676|Device|Moving cupping|"We use a black opaque eye mask to shield the patient's eyes and choose different sizes of cup according to the location of the treatment (There are three sizes of cups)
~(1) First apply Vaseline to the skin lesions area; (2) Then hold the 95% ethanol cotton ball with tweezers, and hold the cup with the facing down, after the cotton ball is ignited, immediately sway down in the cup and then exit, and quickly buckle the cup to the skin lesions area. (3) After using the cup to absorb the skin lesions area, hold the cup body in one hand and push and pull the cup along the certain route with a little strength, so that the skin purple color of the treatment area is suitable. (4) Apply even force when pushing the cup to prevent the cup from falling off due to air leakage. (5) Acting on the skin lesions area 30 times, change cup 5 times per push and pull, the interval is not more than 10 seconds."
15861194|NCT03952676|Device|Moving cupping placebo|Using of special perforated cups, the manipulation method is the same as the intervention group.
15861195|NCT03952663|Procedure|inferior alveolar nerve lateralization and dental implant placement.|inferior alveolar nerve lateralization for placement of sufficiently long dental implants.
15861196|NCT03952663|Procedure|platelet rich fibrin membrane around the nerve|platelet rich fibrin membrane is prepared from the patient's blood and placed around the nerve.
15861197|NCT03952650|Drug|Chloroquine Phosphate|Chloroquine phosphate is approved for suppressive treatment (prophylaxis) and for acute attacks of malaria due to P. vivax, P. malariae, P. ovale, and susceptible strains of Pf. Chloroquine is a blood-stage schizonticide, highly active against replicating forms of blood-stage drug- sensitive parasites. As such, it is routinely employed as first-line prophylaxis against development of patent parasitemia and clinical malaria in non-immune travelers to areas with chloroquine sensitive Pf. In the pilot, chloroquine administration will begin with a loading dose 2 days prior to PfSPZ Challenge and finishing with a maintenance dose 5 days after PfSPZ Challenge. In the main phase, chloroquine will be first administered as a loading dose 2 days prior to PfSPZ Challenge and continuing weekly using a maintenance dose for a total of 10 doses, finishing with a last dose 5 days after the third injection with PfSPZ Challenge.
15861198|NCT03952650|Biological|PfSPZ Challenge|PfSPZ Challenge (NF54) acts as the immunogen in the PfSPZ-CVac approach to vaccinating against malaria. Participants will receive either one (in the pilot phase) or 3 (in the main phase) 400,000 or 300,000 aseptic, purified, cryopreserved, fully infectious PfSPZ injections by DVI (with concurrent administration of antimalarial drugs). Following immunization, participants in the main phase will be followed through the transmission season in order to assess vaccine efficacy.
15861199|NCT03952650|Drug|Pyrimethamine|"Pyrimethamine has been FDA approved for acute treatment and chemoprophylaxis of malaria due to susceptible strains of plasmodia.
~Pyrimethamine has been shown to possess both liver and blood stage activity. In this study, we plan to use a higher dose of pyrimethamine, 75 mg orally for either one or two days each month. The pilot arms will receive either a total of 1 daily dose or 2 daily doses. The main arms will receive a total of 3 daily doses or a total of 6 doses."
15861200|NCT03952650|Drug|Coartem|Antimalarial (Coartem ) will be administered to all participants twice during the study, approximately 2 weeks prior to the first vaccination in order to clear pre-existing parasitemia that may interfere with immunity development. The second dose will be given approximately 2 weeks prior to the 3rd vaccination in order to clear any parasitemia infection that may have happened naturally during the vaccination period and prior to the follow up period.
15861201|NCT03952650|Drug|ibuprofen|Ibuprofen likewise is not a part of the investigational product/regimen, but will be provided to participants in the chloroquine arm (Arm 4) if required to mitigate typical symptoms of malaria infection such as headache, myalgia, fever and chills.
15861202|NCT03952637|Biological|AAV9-GLB1|The risks of administering this treatment in a subject with GMl gangliosidosis are not completely known. The major risk associated with intravenous infusion is from the subject's immunological response to the viral capsid and/or the beta-gal protein. To reduce this possibility, immune modulation therapy is being started prior to vector delivery and maintained for six months afterward. There is a theoretical risk that the integration of a small percentage of the rAAV vector DNA into the host cell genome could cause cellular transformation to cancer cells and lead to a malignancy. This has never been seen in subjects receiving intravenous AAV9 gene therapy so the risk of this complication, is likely very low.
15861203|NCT03952637|Drug|Rituximab|We are proposing the use of immune modulation to transiently deplete B-cells using rituximab. It will be infused at -21 days and -14 days before gene transfer.
15861204|NCT03952637|Drug|Sirolimus|Sirolimus is a macrocytic lactone that inhibits T lymphocyte activation and proliferation by inhibiting activation of mammalian Target of Rapamycin (mTOR) kinase that suppresses cytokinedriven T-cell proliferation. We plan to give sirolimus from day -21 to 6 months post gene transfer.
15861205|NCT03952637|Drug|Methylprednisolone|Subjects will receive IV methylprednisolone 1 mg/kg or a maximum dose of 50 mg, 60-120 minutes prior to vector administration on day 0 to mitigate potential acute innate immune response against the vector.
15861206|NCT03952637|Drug|Prednisone|Prednisone (oral solution, dose 0.5 mg/kg) will be taken daily on Days 1-3.
15861207|NCT03952637|Diagnostic Test|Audiology assessmentwith ABR|The audiology assessment will be performed in the Audiology Clinic using a standard audiogram to measure thresholds for pure tones and speech, word recognition, tympanometry, and otoacoustic emissions if the subject is capable and tolerant of these measures. The assessment will take approximately 30 minutes. The ABR is a noninvasive neurophysiologic test to evaluate electrical signal transmission from the 8th cranial nerve to the brainstem and the cortex in response to specific tones. Electrodes are placed on the scalp and on each earlobe. An earphone gives off a brief click or tone and the electrodes pick up the brain's responses to these sounds and record them. This will be performed by a trained neurophysiology technician to monitor possible change in hearing during treatment. The procedure will be performed in the Interventional Radiology suite while the subject is sedated following the MRI, fMRI, and MRS of the brain.
15861208|NCT03952637|Diagnostic Test|Bone density scan (DEXA|Type II subjects -This is a noninvasive enhanced form of Xray that is used to measure bone loss. Loss of bone density is a known complication with GM1 gangliosidosis due to decrease in weight-bearing activities with disease progression. The procedure will be performed in the Nuclear Medicine Department. The subject s femur, spine, and whole body will be scanned at baseline and then yearly for 3 years. The procedure will take approximately 10 minutes and may be limited due to the subject s cooperation.
15861261|NCT03952390|Other|control|
15861262|NCT03952390|Other|sepsis|
15861263|NCT03952377|Drug|SX600|Transforaminal Epidural Injection
15861213|NCT03952637|Procedure|Lumbar puncture|Performed to obtain cerebrospinal fluid (CSF) to measure GM1 ganglioside, beta-gal enzyme, AAV antibodies, Pentasaccharide biomarkers and other research tests. CSF will also be sent for cell count and differential, glucose, protein, and culture as well as CSF neurotransmitters. The amount of CSF obtained will be less than or equal to 0.75 mL/kg body weight. The procedure will be performed while under sedation following MRI imaging. If a sedated MRI is not being performed, then the LP will be performed in consultation with the pediatric consult service using conscious sedation and local anesthesia. The procedure will take approximately 15 minutes.
15861214|NCT03952637|Procedure|Brain MRI/MRS/fMRI|Magnetic resonance imaging (MRI), functional MRI (fMRI) and spectroscopy (MRS) Procedure/Surgery - The subject will undergo noncontrast MRI, including DTI sequences, fMRI, and MRS in the 3T scanner using the same image acquisition sequences and the same MRS voxels to capture the same metabolites as prior sequencing under natural history protocol 02-HG0107. The MRI, fMRI, and MRS will be interpreted for signs of disease progression or stabilization and any signs of treatment toxicity by two board-certified radiologists with specialty training in neuroradiology. The scan will require anesthesia. Sedation will be administered by the anesthesia service after a preanesthesia consultation to assess risk. The type of sedation and whether the subject will be intubated for the procedure will be at the discretion of the anesthesia service.
15861215|NCT03952637|Behavioral|Neurocognitive testing|Type II Subjects -The Vineland-3 will be administered under the supervision of a psychologist. The Vineland-3 provides several types of scores, measure of personal and social independence designed to examine the domains of communication, daily living skills, social skills and motor development. Other standard neurocognitive instruments may be used depending on the subject s ability, and some visits will (may) include a measure of intelligence /cognitive development if the child is able to achieve a basal score. Neurocognitive testing will take approximately 2-3 hours depending on subject cooperation. The assessments will not address sensitive topics. Type I Subjects - Bayley Scales of Infant and Toddler Development (BSIDIII), a well-normed and validated, examiner administered evaluation of cognition, language, and motor skills for children from birth to 42 months of age.
15861216|NCT03952637|Other|Neurology exam|Neurology exam will be performed by a neurologist in the screening and followup appointments to monitor for any adverse reactions and to assess for clinical response to the treatment. The exam will be scripted for consistency within subject visits and between subjects and will take approximately 30 minutes to one hour. The exam will be videotaped. The exam may be limited due to the subject s cooperation level.
15861217|NCT03952637|Behavioral|PICC line placement|PICC line placement will be done under sedation in Interventional Radiology. The procedure will be done under sedation and may take 20 minutes. A chest Xray will be done after placement to confirm correct positioning of the catheter.
15861218|NCT03952637|Procedure|Skeletal survey|A skeletal survey will be performed to assess the degree of skeletal involvement of the disease. This will include X-rays of the a/p lateral spine, chest, and pelvis. The exam will take approximately 30 minutes. The exam may be limited due to the subject s cooperation level.
15861219|NCT03952637|Procedure|Skin biopsy|Skin biopsy will be performed on subjects who have not already had a skin biopsy under the 02-HG-0107 protocol. The procedure will be done under sedation using local anesthetic. After washing the skin with chlorhexidine and numbing the skin with injectable lidocaine, a 3mm circle of skin is removed under sterile conditions and the wound is dressed. The entire procedure takes approximately 5 minutes.
15861220|NCT03952637|Procedure|Speech and modified barium swallow study|Performed as a marker of response to treatment and safety. The swallow assessments will include a parental swallowing questionnaire and cranial nerve assessment. The NIH Swallowing Questionnaire from the Speech Language Pathology Section is designed to identify the presence and or absence of functional swallowing dysfunction as perceived by the subject and or caregiver. This 4point scale assists with further identification of clinical/research assessments of oral pharyngeal swallowing function if indicated in the form of a modified barium swallow. In addition to swallow assessments, tape recording of speech will also be included with diadochokinetic tasks and sustained phonations as well as speech if able. Recordings will be stored on a shared drive accessible only by the study team. The assessment may take approximately 30 minutes to 1 hour.
15861221|NCT03952637|Procedure|Ophthalmology exam|The ophthalmology exam will be performed by an ophthalmologist in the screening and follow-up appointments to support subtype diagnosis and assess efficacy. Pictures of bilateral macula will be taken and saved to asecure database. OCT will also be performed. These exams will only be administered to Type I subjects.
15861222|NCT03952611|Procedure|Colonoscopy|Using an instrument called colonoscope which is used to detect colonic polyps
15861223|NCT03952611|Device|distal Cap|Using an instrument called cap at end of colonoscope which is used to straighten colon folds
15861224|NCT03952611|Device|Endocuff|Using an instrument called Endocuff at end of colonoscope which is used to straighten colon folds
15861225|NCT03952598|Device|3T MRI scanner|Research proton MRS (lH-MRS)followed by DW-MRI
15861232|NCT03952572|Drug|Cyclophosphamide|750mg/m² ivgtt on day 1
15861233|NCT03952572|Drug|pegylated liposomal doxorubicin|40mg/m² ivgtt on day 1
15861234|NCT03952572|Drug|Vincristine|1.4mg/m²(Maximum 2 mg) ivgtt on day 1
15861235|NCT03952572|Drug|Prednisone|Prednisone100mg/m² po on day1-5
15861236|NCT03952572|Drug|Doxorubicin|50mg/m² ivgtt on day 1
15861264|NCT03952377|Drug|Placebo|Transforaminal Epidural Injection
15861265|NCT03952364|Other|PredictSURE IBD™|To evaluate a test called PredictSURE IBD™ in the US population
15861266|NCT03952351|Radiation|CT Coronary Angiography (CTCA)|CTCA scan in accordance with British Society of Cardiovascular Imaging CT guidelines
15861271|NCT03952325|Drug|Tesetaxel|Tesetaxel at 27 mg/m2 orally Q3W
15861272|NCT03952325|Drug|Nivolumab|Nivolumab at 360 mg by intravenous infusion Q3W
15861240|NCT03952546|Device|Saline-coupled Bipolar Sealer|The Aquamantys® System is a commercially available device used routinely used in the operating room for a wide variety of surgical cases. It allows for temperatures to stay at approximately 100°C, nearly 200°C less than conventional devices, which produces a tissue effect without the charring associated with other methods. The temperature is sufficient to shrink collagen fibers in the walls of blood vessels, effectively sealing the blood vessels, resulting in the reduction in bleeding from both soft tissue and bone. The device can be used to spot coagulate vessels that are actively bleeding or to broadly paint tissue surfaces to prevent bleeding or treat active oozing.
15861241|NCT03952546|Device|Unipolar electrocautery|The Coviden ForceTriad™ energy platform is a full-featured electrosurgical system that provides electrosurgical cutting and coagulation, bipolar functionality, and vessel sealing in a single generator.
15861242|NCT03952533|Dietary Supplement|Dav|Daily oral administration of a food supplement constituted by α-lipoic acid, magnesium, vitamin B6 and vitamin D in tablets of 1,2 g (Dav®, Lo.Li. Pharma, Rome, Italy)
15861243|NCT03952520|Other|Standard Approach (SA)|The multifaceted implementation strategies for SA sites were identified through centralized Intervention Mapping. Before SNaP implementation starts, the specific set of one-size-fits-all implementation strategies was determined through a formal process with investigators, government stakeholders, and clinical representatives.
15861244|NCT03952520|Other|Tailored Approach (TA)|The Tailored Approach includes the multifaceted strategy that will be offered to the Standard Approach condition. It will also be tailored to match site-specific barriers to implementation of SNaP at that site. The strategy for TA sites involves a 2-day site-specific training, monthly coaching calls, and an external technical assistance hotline to help organizations to tailor implementation strategies to address their site-specific needs. At the 2-day TA training, the TA sites will be guided on developing site-specific implementation plans, in which they may use additional implementation strategies that they have identified themselves or selected from a list developed by the central team.
15861245|NCT03952507|Drug|JNJ-64417184 600 (Oral Tablet Formulation)|Participants will receive 600 mg of JNJ-64417184 as oral tablet.
15861246|NCT03952507|Drug|JNJ-64417184 (Oral Suspension Formulation)|Participants will also receive JNJ-64417184 600 mg as oral suspension.
15861247|NCT03952494|Genetic|Genomind®Professional PGx Express TM|The current test includes the analysis of fifteen pharmacodynamic genes and nine pharmacokinetic genes that have been shown in numerous clinical studies to have implications for response to treatments used for depression, anxiety, obsessive-compulsive disorder (OCD), attention-deficit/hyperactivity disorder (ADHD), bipolar disorder, Posttraumatic Stress Disorder (PTSD), autism, schizophrenia, chronic pain and substance abuse. The genes assessed by the assay target major hepatic enzymes and key neurotransmitter pathways including serotonin, dopamine, norepinephrine and glutamate.
15861248|NCT03952481|Drug|Lifitegrast 5% Ophthalmic Solution|Participants will received lifitegrast 5% ophthalmic solution twice a day in each eye for approximately 4 weeks.
15861249|NCT03952468|Device|Transcranial Magnetic Stimulation|Administration of rapidly fluctuating magnetic field, delivered over the dorsolateral prefrontal cortex.
15861250|NCT03952468|Other|Brief Cognitive Behavioral Therapy|BCBT is a well-established and efficacious treatment that is an extension of Cognitive Behavioral Therapy, a treatment that is widely implemented across VA health care systems.
15861251|NCT03952455|Procedure|Bilateral surgical implantation of DBS system to Nucleus Accumbens|We plan to use the SceneRay 1242 (SceneRay, SuZhou, China) electrode with a diameter of 1.27 mm and 4 contacts. The SceneRay 1242 electrode combined with the SceneRay 1181 implantable pulse generator has the advantage of adaptive coverage area for the Ventral Capsule/Ventral Striatum, enabling simultaneous implantation in the nucleus accumbens (NAc; 2 ventral contacts) and the anterior limb of the internal capsule (ALIC; 2 dorsal contacts) with independently programmed parameters such as frequency, amplitude, and voltage; and remote and wireless programing, which allows for convenient and prompt adjustments in emergency situations. The contact length is 3.0 mm and the spacings between the ventral and dorsal contacts are 2 mm, 4 mm, and 4 mm, respectively, spanning a total length of 22.5 mm (3 + 2 + 3 + 4 + 3 + 4 + 3 mm, with 0.5 mm projecting from the electrode tip).
15861252|NCT03952442|Other|standardized nutrition education|Give nutrition health education every two weeks and regular survey and intervention. The education booklets are made based on the guideline and characteristics of the disease.
15861253|NCT03952442|Other|routine nutrition education|Give nutrition education if the patient visits the clinics. Irregular survey and intervention were given to the patients.
15861254|NCT03952429|Behavioral|Anti Alcohol App with Active Cognitive Bias|The active version includes an active form of cognitive bias modification, i.e. the user has to avoid alcohol stimuli 90% of the time, while they approach soft drinks 90% of the time.
15861255|NCT03952429|Behavioral|Inactive Cognitive Bias Modification|The control version includes an placebo form of cognitive bias modification, i.e. the users avoid and approach alcohol and softdrink stimuli for an equal number of trials.
15861256|NCT03952416|Behavioral|Enhanced Medical Rehabilitation (EMR)|"EMR is a set of behavioral skills that therapists can incorporate into their daily therapy sessions to increase patient engagement and achieve a high intensity of therapy, thereby improving functional and psychosocial outcomes of patients in medical rehabilitation. EMR was built on theories of behavior change, including social cognitive theory and self-regulatory theory, and their applications to patient engagement, such as the Health Action Process Approach and motivational interviewing. It has three foci: (1) a patient-directed, interactive approach stemming from patient-centered goals (Patient as boss); (2) frequent feedback to patients on their efforts and progress (Link activities to personal goals); and (3) increased rehabilitation intensity (Optimize intensity)."
15861257|NCT03952403|Drug|HLX10, an engineered anti-PD-1 antibody|HLX10 will be administered as IV infusion at a dose of 4.5mg/kg on Day 1 of each 21-day cycle until loss of clinical benefit or up to 2 year.
15861258|NCT03952403|Drug|HLX04, a bevacizumab biosimilar|HLX04 will be administered as IV infusion at a dose of 15 milligrams per kilogram (mg/kg) on Day 1 of each 21-day cycle until progressive disease, unacceptable toxicity, death or up to 2 year.
15861259|NCT03952403|Drug|Carboplatin|Carboplatin will be administered at area under the concentration-time curve (AUC) 5 on Day 1 of each 21-day cycle for 4 cycles, or until loss of clinical benefit whichever occurs first.
15861260|NCT03952403|Drug|Pemetrexed|Pemetrexed will be administered as IV infusion at a dose of 500 milligrams per square meter (mg/m2) on Day 1 of each 21-day cycle until progressive disease, unacceptable toxicity, death or up to 2 year.
15861276|NCT03952312|Behavioral|Oncotool Intervention (symptom reporting + TKI education)|OncoTool is a website intended to improve self-management practices for helping cancer patients cope with side effects and improve health-related quality of life. OncoTool provides symptom education and management for dealing with the numerous physical and mental side effects associated with TKIs (e.g., fatigue, nausea, skin toxicity). OncoTool is a website designed to improve TKI adherence by improving quality of life and TKI associated symptom burden, as well as providing a portal for provider-patient communication via a bi-weekly health questionnaire. Both intervention and active comparator conditions are administered to participants for 8 weeks.
15861277|NCT03952312|Behavioral|Oncotool Control (health information)|OncoTool is a health promotion website with health education on subjects like nutrition and exercise specific to cancer patients, as well as general advice on lifestyle choices and prevention. The Oncotool control has similar TKI education content as the experimental content but without the side effect education or physician notification. Both intervention and active comparator conditions are administered to participants for 8 weeks.
15861278|NCT03952299|Drug|Oxybutynin Transdermal Patch|Transdermal patch of oxybutynin will be used instead of oral oxybutynin.
15861279|NCT03952299|Drug|Oral Oxybutynin|Oral administration of oxybutynin (5mg) every 8 hours in the hospital.
15861280|NCT03952286|Drug|ED-Dispensing home and school supervision|"Oral prednisolone based on body weight to achieve a daily dose of 2mg/kg/day not to exceed 40 mg per day for 5 days or its equivalent (provided in the emergency department),
~360 ug of budesonide inhalation powder once-daily for at-home use, and
~albuterol sulfate as needed for relief of acute respiratory symptoms."
15861281|NCT03952273|Combination Product|PCI with BioMatrix Alpha™ stent|Randomozation between either Sirolimus eluting and endothelial progenitor cell Combo™ stent or Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent
15861282|NCT03952273|Combination Product|PCI with Combo™ stent|Randomozation between either Sirolimus eluting and endothelial progenitor cell Combo™ stent or Biolimus eluting absorbable polymer coated BioMatrix Alpha™ stent
15861283|NCT03952260|Other|Fasting time for clear fluid prior to anaesthesia|"This study is to evaluate the latest fasting protocol that is currently adopted and recommended by United Kingdom, France and Royal Children Hospital Melbourne.
~The research question is should we change our fasting protocol for paediatric patients prior to operation The anaesthesia service is being studied. Prior to induction, the amount of abdominal contents was examined using ultrasound scan. In addition, parents will complete a questionnaire after the surgery to assess anxiety level of patients before and after the surgery."
15861284|NCT03952247|Device|Single Use Bronchoscopy for PDT|optical guidance of percutaneous tracheotomy is done by single use bronchoscopy
15861285|NCT03952247|Device|Conventional Multi Use Bronchoscopy for PDT|optical guidance of percutaneous tracheotomy is done by conventional multi use bronchoscopy
15861286|NCT03952234|Drug|L-Citrulline|To determine the safest maximum dose of L-Citrulline which could be used as a potential treatment for adults with disorder of energy metabolism called MELAS
15861287|NCT03952221|Device|Continuous ultrasound therapy|continuous US therapy once a day, 9 minutes/session for two weeks (10 occasions) with BTL-4825S Premium device, 5 cm2 probe, 3 MHz frequency, 1,5 W/cm2 SATA intensity
15861288|NCT03952221|Device|pulsed ultrasound therapy|pulsed US therapy once a day, 9 minutes/session, for two weeks (10 occasions) with BTL-4825S Premium device, 5 cm2 probe, 3 MHz frequency, 1,5 W/cm2 SATA intensity, 50% duty cycle
15861289|NCT03952221|Device|US and electrotherapy (sonotens)|US and electrotherapy (transcutaneous electrical nerve stimulation) once a day, 10 minutes /session, for two weeks (10 occasions) with BTL-4825S Premium device, 5 cm2 probe, US: 3 MHz frequency, 0,5 W/cm2 SATA intensity, TENS: application in conventional mode at 100 Hz frequency and 100 μs wavelength
15861290|NCT03952221|Device|Sham ultrasound therapy|sham US therapy once a day for two weeks (10 occasions) with BTL-4825S Premium device, 5 cm2 probe, 0 MHz frequency, 0 W/cm2 SATA intensity
15861291|NCT03952208|Other|Neurocognitive Testing|A comprehensive assessment of neuropsychometric measures to evaluate cognitive functioning.
15861292|NCT03952182|Other|Spinal Orthosis (LSO, TLSO)|spinal orthosis prescribed for specific spinal fracture (TLSO for thoracic or high lumbar fracture, LSO for lumbar fracture)
15861293|NCT03952182|Other|No orthosis|no orthotic given for spinal fracture. These patient's will be given a bending restriction
15861294|NCT03952169|Dietary Supplement|Lactobacillus paracasei dietary supplement|a commercial probiotic dietary supplement
15861295|NCT03952169|Other|Placebo controls|placebo with a similar appearance to probiotics supplement
15861296|NCT03952156|Genetic|HMI-102|HMI-102 is an AAVHSC15 vector containing a functional copy of the human PAH gene
15861297|NCT03952156|Genetic|HMI-102|"Control subjects will generally have the same assessments as treated subjects.
~Control subjects will undergo pre-baseline procedures to confirm that they are eligible to receive treatment with HMI-102. Once eligible control subjects are dosed with HMI-102, they will initiate the same post-dose procedures as subjects who received HMI-102."
15861298|NCT03952143|Drug|LY900014|Administered SC
15861299|NCT03952143|Drug|Insulin Lispro|Administered SC
15861300|NCT03952143|Drug|Insulin Glargine|Administered SC
15861301|NCT03952143|Drug|Insulin Degludec|Administered SC
15861302|NCT03952130|Drug|LY900014|Administered SC
15861303|NCT03952130|Drug|Insulin Lispro|Administered SC
15861304|NCT03952130|Drug|Insulin Glargine|Administered SC
15861305|NCT03952130|Drug|Insulin Degludec|Administered SC
15861306|NCT03952117|Device|transcranial direct current stimulation|tDCS will be administered through a pair of conductive rubber electrodes covered by saline soaked sponges (35 cm2). The current will be delivered continuously at 2 mA for 30 min through a battery-driven constant-current stimulator (Sooma Oy, Helsinki, Finland).
15861307|NCT03952104|Other|Strength training|Strength training
15861312|NCT03952052|Other|Determination of mutation|Recurrent mutation determination by digital PCR and next generation sequencing
15861313|NCT03952039|Drug|FEDRATINIB|A potent and selective inhibitor of JAK2 kinase activity
15861314|NCT03952039|Drug|Best Available Therapy (BAT)|Best available therapy (BAT)
15861315|NCT03952026|Procedure|osteosynthesis of the pelvis|Osteosynthetic Fixation of the pelvic fracture
15861316|NCT03952013|Other|To explore health literacy levels in patients hospitalized for acute neuro-cardiovascular diseases i.e. stroke, myocardial infarction, or heart failure|All patients included and followed within one of the three cohorts studies: LOOP-HF, HIBISCUS-STEMI and HIBISCUS-STROKE who accepted to participate in the study, will be contacted by phone (attempted calls are set to 3 to reach the patient), mail or during a consultation, to answer to a health literacy questionnaire. The patient will participate in the study only once. The estimated duration is therefore estimated at 1 day for each patient and two month for the study. Thanks to the many following periods within the cohorts (6 months, 1 year and 18 month), we will measure health literacy at different times of the care.
15861317|NCT03952000|Behavioral|Exercise|A 60 minute walk at 60% maximal oxygen uptake.
15861318|NCT03951987|Drug|4 ml CG5503|4 ml of the CG5503 infusion solution corresponding to 40 mg CG5503 (tapentadol hydrochloride).
15861319|NCT03951987|Drug|5 g charcoal powder|Oral administration of 5 g charcoal powder suspended in 100 ml tap water.
15861320|NCT03951974|Behavioral|Social Emotion Regulation Strategy Development|Participants will work one-on-one with an interventionist to develop goals (in the form of implementation intentions) to develop social emotion regulation strategies to combat frequent emotional challenges.
15861321|NCT03951974|Behavioral|Control|Participants will work one-on-one with an interventionist to report on their frequent emotional challenges, and report the emotion regulation strategies that they frequently use to combat them.
15861322|NCT03951961|Drug|Midostaurin|50mg Midostaurin bid for 12 months
15861323|NCT03951948|Other|retrospective analysis of surgical performance, clinical and radiologic outcome|retrospective analysis of surgical performance, clinical and radiologic outcome
15861324|NCT03951935|Other|Oswestry Disability Index (ODI) questionnaire|Participant's level of low back pain and the extent to which the pain impacts his/ her daily life activities and social life are estimated with the standardized Oswestry Disability Index questionnaire
15861325|NCT03951935|Diagnostic Test|self-paced walking test (SPWT)|walking back and forth at a self-selected pace along a hallway at the University Hospital until the onset of claudication, pain or until reaching the time limit of 30 minutes. Kinematic and electromyographic (EMG) data will be recorded every 3 minutes.
15861326|NCT03951922|Behavioral|Horticultural activity|Therapeutic horticulture activities are plant-related activities that include but not limited to digging, watering, planting, weeding, trimming, fertilizing, mulching, harvesting, learning about organic farming, and exploring options to incorporate horticulture into daily activities
15861327|NCT03951909|Behavioral|Physiotherapy activity and awareness intervention: PAAI|10 to 12 persons will be invited to each group. The intervention will consist on 8 weekly sessions including the same key elements each time: introduction with a mindfulness exercise and a ball game, several movements while sitting on a chair, standing proprioceptive exercises with wooden sticks and exercises to raise awareness of muscle tensions in the body, active movements stimulating the balance, coordination and breathing and finally relaxation and a short closing round.
15861328|NCT03951909|Behavioral|Psychological intervention: Teaching recovery techniques (TRT)|TRT is composed of five two-hour group teaching sessions with up to 15 participants. The first two sessions deal with intrusive thoughts and feelings: problems such as bad memories, nightmares, and flashbacks. The third session deals with arousal, coming to the surface as difficulties in relaxing, concentrating and sleeping. The fourth and fifth sessions deal with avoidance: ones fears, and difficulties in facing up to reminders of the war and violence.
15861329|NCT03951896|Biological|PRP|A venous blood sample of 8.5 ml were obtained from all patients. For the treatment group, the blood samples were treated with 1.5 ml ACD-A or sodium citrate to achieve anticoagulation. The blood was then centrifugated for 5 minutes with RCF 1200 G velocity to clump red blood cells, and then centrifugated for 10 minutes in same velocity to obtain platelet concentrate. 2 ml's of the resulting platelet rich plasma was injected to the shoulder of the subjects.All of the injections were done every two weeks, for a total of 3 times using 21 G injection needles with injection technique of posterior approach.
15861330|NCT03951896|Other|Saline injection|2 ml's of NaCl solution with 0,9% concentration was applied to the shoulders of the participants.
15861331|NCT03951883|Other|Increased Egg Consumption|Subjects will be instructed to use a weekly food purchase supplement for inclusion of 2 additional eggs per day to be added to subject's typical daily diet.
15861332|NCT03951883|Other|Typical diet|Subjects will be instructed to maintain their current dietary patterns.
15861333|NCT03951870|Behavioral|Neuromodulation via fMRI Neurofeedback task|Two active neurofeedback groups will practice to up regulate their designated neural targets via identical experimental protocol (varying only the origin of the feedback).
15861334|NCT03951870|Biological|Hepatitis B vaccination|Subjects will be vaccinated against Hepatitis B
15861335|NCT03951857|Other|Resistance exercise with a gym stick|Exercise intervention: The resistance exercise intervention is performed with a gym stick for 3 times a week for 12 weeks. Exercise load is gradually increased by the number of times the band is wound and the speed of motion by dividing into three stages in 1-4 weeks (1st stage), 5-8 weeks (2nd stage) and 9-12 weeks (3rd stage).
15861336|NCT03951844|Device|BRIDGE/EMPATIA exoskeleton|The participant wears the exoskeleton on his/her left arm, and he/she controls it by means of a joystick or vocal commands.
15861337|NCT03951831|Drug|REGN2810|Cemiplimab (REGN 2810) is administered starting at week 4 at a dose of 350mg IV every 3 weeks (flat dose) for up to 55 weeks or intolerable side effect or progression of disease.
15861338|NCT03951831|Drug|Degarelix|Degarelix is administered subcutaneously (SC) at a dose of 240mg once.
15861339|NCT03951831|Drug|Leuprolide Acetate|Leuprolide acetate is provided at a dose of 22.5mg SC every 3 months.
15861340|NCT03951831|Drug|Docetaxel|Docetaxel is administered starting at week 10 at a dose of 75 mg/m2 every 21 days for up to 6 cycles.
15861341|NCT03951805|Drug|Insulin icodec|Administered subcutaneously SC once weekly. Starting dose will be 70U.
15861342|NCT03951805|Drug|Insulin Glargine|Administered subcutaneously SC once daily.The starting dose will be 10U.
15861343|NCT03951779|Device|Exercise cardiac magnetic resonance imaging|Subjects will exercise on a treadmill and immediately following the completion of the stress protocol, subjects will undergo cardiac magnetic resonance imaging
15861344|NCT03951766|Behavioral|Smiling Instead of Smoking (SiS) App Version 2|The investigators have developed a smartphone app that acts as a behavioral, in-the-pocket coach and uses positive psychology exercises to enhance quitting success. It is anonymous, portable, and provides just-in-time support, an important feature for smokers who smoke under specific conditions and circumstances. To support treatment, investigators use a positive psychology approach. The smartphone app administers positive psychology exercises to enhance and/or maintain positive affect, which is hypothesized to stimulate nondaily smokers to enact healthier alternatives to smoking by broadening their thought-action repertoire, increasing confidence, and decreasing craving and defensiveness about smoking-related health information.
15861345|NCT03951753|Drug|Tirzepatide|Administered SC
15861346|NCT03951753|Drug|Semaglutide|Administered SC
15861347|NCT03951753|Drug|Placebo|Administered SC
15861348|NCT03951740|Device|Fitbit Charge 2|Energy expenditure (kcal) assessed by this activity tracker will be compared with indirect calorimetry (Oxycon Mobile) during a laboratory activity protocol. Two groups will be assessed: patients with stable coronary artery disease (CAD) and patients with heart failure with reduced ejection fraction (HFrEF).
15861349|NCT03951740|Device|Mio Slice|Energy expenditure (kcal) assessed by this activity tracker will be compared with indirect calorimetry (Oxycon Mobile) during a laboratory activity protocol. Two groups will be assessed: patients with stable coronary artery disease (CAD) and patients with heart failure with reduced ejection fraction (HFrEF).
15861350|NCT03951740|Device|Oxycon Mobile|"The Oxycon Mobile will be used as the reference method/golden standard to calculate energy expenditure (kcal). This device (consisting of a face mask and gas analyzer unit) will be worn during the entire laboratory activity protocol.
~Two groups will be assessed: patients with stable coronary artery disease (CAD) and patients with heart failure with reduced ejection fraction (HFrEF)."
15861351|NCT03951727|Device|Endovascular treatment for PAD|Long femoropopliteal stenting with SuperA devices
15861352|NCT03951714|Behavioral|Marketed experience application on adherence|To evaluate the effect of electronic capture of medication intake through a smartphone app on treatment's adherence
15861353|NCT03951701|Other|Evaluation of the supportive care|Evaluation of interest of a systematic screening for oncological supportive care needs
15861354|NCT03951688|Other|Experimental-Multi-modal exercise program|"Each home-based session (48) starts with 7 minutes of moderate warm-up exercises focusing on mobility and flexibility. Secondly, the strengthening exercises consist of knee extensions, knee flexions, hip abductions, ankle plantar flexions, and ankle dorsiflexions. Thirdly, a set of balance exercises including knee bends, backwards walking, walking and turning around, sideways walking, tandem stance, tandem walk, one leg stand, heel walking, toe walking, toe to heel walking backwards, sit-to-stand, and stair walking.
~Finally, participants are instructed to walk at their usual pace for at least 10 minutes."
15861355|NCT03951662|Other|Alcoholic Hepatitis Group|Alcoholic hepatitis is defined as having a total bilirubin level >3mg/dL and AST level>50U/L
15861356|NCT03951662|Other|Heavy Drinking Controls without Hepatitis|Normal levels of AST, ALT and total bilirubin and without evidence of cirrhosis or hepatosplenomegaly
15861357|NCT03951649|Drug|Occipital Nerve Block|This is an open label randomized controlled trial evaluating response to bupivacaine occipital nerve block compared to Tylenol/Caffeine cocktail in treatment of pregnant patients seeking care of headache.
15861358|NCT03951636|Procedure|Chlorhexidine|mechanical debridement and chemical decontamination: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments and the implant abutment surface will be cleaned by copious irrigation with chlorhexidine
15861359|NCT03951636|Procedure|Er:YAG laser|mechanical debridement and chemical decontamination: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments and the implant abutment surface will be cleaned by copious irrigation with chlorhexidine
15861360|NCT03951636|Procedure|Air Powder|mechanical debridement and chemical decontamination: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments and the implant surface will be cleaned by copious irrigation with Clorhexidine. Furthermore, an Air-Powder treatment will be provided on the implant/abutment surface.
15861361|NCT03951623|Drug|HMPL-523|HMPL-523 will be oral administrated once daily for 8 weeks and 16 weeks open-label treatment.
15861362|NCT03951623|Drug|Placebo|HMPL-523 matching placebo will be oral administrated once daily for 8 weeks and 16 weeks open-label treatment.
15861363|NCT03951610|Device|Test lens|contact lens
15861364|NCT03951610|Device|Control lens|contact lens
15861365|NCT03951597|Drug|combined therapy using oxaliplatin and gemcitabine chemotherapy, Lenvatinib and PD1 antibody (JS001)|"Gemox chemotherapy Day1 oxaliplatin 85mg/m2+ gemcitabine 1g/m2, Day8 gemcitabine 1g/m2 Three weeks is a course of treatment with a total of 6 courses.
~Lenvatinib (8mg/d), continuous use for 1 year.
~PD-1 antibody (JS001) (240mg every 3 weeks), continuous use for 1 year."
15861366|NCT03951584|Other|ISSNHL with vertigo|Participants who suffered from ISSNHL with vertigo will be included in this study. Participants will undergo vestibular function tests including caloric test, sensory organization test, video head impulse test and vestibular evoked myogenic potentials at baseline and 2 months after onset as primary outcome, to evaluate the damage and prognosis of vestibular function.
15861367|NCT03951571|Drug|Anlotinib Hydrochloride|Before breakfast, take an Anlotinib hydrochloride placebo once a day, 12 mg (1 pill) at a time. Continuous oral administration for two weeks and stop for one week. Three weeks (21 days) for a treatment cycle. The total treatment cycles is six.
15861368|NCT03951571|Drug|Placebo Oral Tablet|Before breakfast, take an placebo once a day, 1 pill at a time. Continuous oral administration for two weeks and stop for one week. Three weeks (21 days) for a treatment cycle. The total treatment cycles is six.
15861369|NCT03951558|Other|Diet for calciuria prevention|Dietary recommendations for water, salt, calcium and proteins according to age and DIR
15861370|NCT03951558|Drug|Hydrochlorothiazide|Hydroclorothiazide recommendations for hypercalciuria
15861396|NCT03951285|Dietary Supplement|NR in BMI-discordant twins|Water-soluble form of vitamin B3, nicotinamide riboside (NR) is used in this study. The NR product name is Niagen, produced by ChromaDex. NR does not cause the known side effects (vasodilation and flushing) of another vitamin B3, niacin.
15861371|NCT03951545|Procedure|First line total knee replacement for gonarthrosis .|Patients requiring 1st line total knee replacement for gonarthrosis with a Hip knee angle (HKA) between 170° and 183°. In the first group (Mechanical) the total knee replacement will be performed with a tibial cut by using extramedullary mechanical sighting and in the second group (Gyroscopic) by using gyroscopic and accelerometric navigation (I-Assist).
15861372|NCT03951519|Other|oral administration of water|Volume expansion via 500 mL of water administered by the patient's nasogastric tube
15861373|NCT03951519|Other|administration of saline solution|Volume expansion via 500 mL of saline (Nacl 0.9%) administered by the venous route
15861374|NCT03951506|Other|Multi-modal exercise program|Each session (48) starts with 7 minutes of moderate warm-up exercises focusing on mobility and flexibility. Secondly, the strengthening exercises consist of knee extensions, knee flexions, hip abductions, ankle plantar flexions, and ankle dorsiflexions. Thirdly, a set of balance exercises including knee bends, backwards walking, walking and turning around, sideways walking, tandem stance, tandem walk,one-leg stand, heel walking, toe walking, toe to heel walking backwards, sit-to-stand, and stair walking. Finally, participants are instructed to walk at their usual pace for at least 10 minutes.
15861375|NCT03951506|Other|Conventional treatment|Each session (48) consist in isotonic exercises of low intensity and joint mobility of the lower extremities. These exercises are usually prescribed in medical consultations for the treatment of knee osteoarthritis.
15861376|NCT03951493|Combination Product|Zoledronic Acid 4Mg Solution for Injection + Hypo-fractured radiotherapy in stereotactic conditions|"All patients receive radiotherapy i.e. treatment on D1, D3 and D5.
~Several radiotherapy schemes are possible:
~20 Gy in 1 fraction;
~27 Gy in 3 fractions of 9 Gy
~30 Gy in 5 fractions of 6 Gy. All patients in the experimental arm receive an intravenous injection of at least 15 minutes of 4 mg zoledronic acid every month for 12 months.
~The first injection must be made no more than 3 weeks before the first day of radiotherapy. It can be performed up to J1 of radiotherapy.
~The injections will be carried out either at the patient's home by the nurses or in the investigator centre."
15861377|NCT03951493|Radiation|Hypo-fractured radiotherapy in stereotactic conditions|"All patients receive radiotherapy i.e. treatment on D1, D3 and D5.
~Several radiotherapy schemes are possible:
~20 Gy in 1 fraction;
~27 Gy in 3 fractions of 9 Gy
~30 Gy in 5 fractions of 6 Gy."
15861378|NCT03951480|Other|Manual medicine|At a rate of 3 sessions of a maximum of 30 minutes each at one week interval. Depending on the clinical evolution, it is possible to stop manual medicine sessions according to the therapist's assessment as in current practice. If the patient has an EVA pain of activity < 2, manipulations will not be continued. The patient being considered as not very symptomatic.
15861379|NCT03951480|Drug|Corticosteroids infiltration|A unique echo-guided infiltration of one syringe of 1 mL of cortisone product
15861380|NCT03951467|Other|Interventional educational toolkit specific to low Health Literacy patients, designed with patients and health professionals.|"Two interviews between the patient and the nurse trained for the study: before discharge from hospital and a telephone reminder between 3 and 5 days after discharge.
~First interview: the nurse will evolve using tools developed in the first phase of the study. The nurse will provide detailed personalized information on the patient's discharge order and illness and the action to be taken depending on the potential situations the patient may encounter.
~Telephone interview: 3 to 5 days after discharge, the nurse will repeat the elements of the first interview with the patient to verify that the information has been properly understood and retained and that the patient is able to adopt appropriate behaviors in high-risk situations."
15861381|NCT03951454|Behavioral|Conexiones|5 Conexiones telephone sessions
15861382|NCT03951454|Behavioral|Taking Time|1 Taking Time telephone session
15861383|NCT03951428|Diagnostic Test|Menstrual Blood Screening Test|The sponsor will be testing women's menstrual blood to investigate the feasibility and efficacy of assessing three early stage cancers via self-collected menstrual blood using FDA approved devices.
15861384|NCT03951415|Drug|PARP inhibitor and Anti-PD-L1|olaparib tablets 300mg twice daily orally and durvalumab 1500mg by IV infusion every 4 weeks
15861385|NCT03951402|Drug|100 mg CG5503 (tapentadol hydrochloride) PR tablet|100 mg CG5503 (tapentadol hydrochloride) PR tablet.
15861386|NCT03951402|Drug|Placebo matching CG5503 PR tablet|Matching placebo tablet to CG5503 PR tablet.
15861387|NCT03951402|Drug|Placebo matching moxifloxacin capsule|Matching placebo capsule to moxifloxacin capsule.
15861388|NCT03951402|Drug|400 mg Moxifloxacin tablet (overencapsulated)|Overencapsulated 400 mg Moxifloxacin tablet.
15861389|NCT03951389|Other|Non-interventional|Non-interventional
15861390|NCT03951376|Behavioral|UPRIGHT intervention|The UPRIGHT intervention design consists of two different phases consecutively implemented in two school years: intensive phase and follow-up phase. During the intensive phase, all stakeholders are trained in the UPRIGHT WELL-BEING FOR US programme (18 skills). The follow-up phase (WELL-BEING FOR ALL) intends not only to maintain the effect of the intensive training in youths, but also to boost the positive mental health atmosphere created in the whole school. To do so, different collective activities will be organized at school level such as celebration of thematic days, activities with the community, and outdoor/indoor activities.
15861391|NCT03951363|Behavioral|interactive Obesity Treatment Approach (iOTA)|The investigators will adapt an evidence-based digital health intervention to promote adherence to nationally recommended diet and physical activity guidelines for patients with chronic kidney disease. The intervention includes goal assignment, goal tracking, and skills training messages.
15861392|NCT03951350|Behavioral|Lifestyle Modification Program (LMP)|"Patients will follow TAU and LMP. This program will consist of 6 weekly group sessions (lasting 90 minutes each) led by an experienced psychologist and complemented by PowerPoint presentations. The content is the following:
~Presentation of the project and psychoeducation on depression.
~Behavior activation.
~Sleep hygiene habits and careful exposure to sunlight.
~Physical activity.
~Adherence to the Mediterranean diet.
~Summary of previous sessions with practical final suggestions."
15861393|NCT03951350|Behavioral|Lifestyle Modification Program (LMP) + Information Communication Technologies (ICTs)|Patients will follow TAU and LMP and will be monitored using a wearable smart wristwatch that will track their daily sleep patterns and physical activity (LMP+ICTs).
15861394|NCT03951337|Drug|64Cu-ATSM|64 Cu-ATSM PET/CT scan
15861395|NCT03951324|Other|Interobserver agreement or Interrater agreement|Interobserver agreement or Interrater agreement using 9 visual criteria for diagnosing VLE clips that feature indeterminate biliary or pancreatic duct strictures
15861397|NCT03951285|Dietary Supplement|NR in BMI-concordant twins|Water-soluble form of vitamin B3, nicotinamide riboside (NR) is used in this study. The NR product name is Niagen, produced by ChromaDex. NR does not cause the known side effects (vasodilation and flushing) of another vitamin B3, niacin.
15861398|NCT03951272|Device|Lyoplant® Onlay/DURAFORM™ Dural Graft Implant|Lyoplant® Onlay will be used as a dura substitute for the repair of the duramater.The DURAFORM™ Dural Graft Implant will be used in the procedures where the repair or substitution of the patient's dura mater is needed.
15861399|NCT03951259|Drug|SM934|In this study, the investigating intervention is oral administration of SM934. SM934 is a water-soluble derivative of arteminisin, which exerts immunosuppressive functions in vitro and in vivo.
15861400|NCT03951259|Drug|Placebos|The placebo pills are made identical to the investigating SM934 in appearance.
15861401|NCT03951246|Other|Cognitive and Motor Training|"In the first phase of the trial, all participants (patients and healthy children) will complete cognitive and motor functions assessment.
~Then the sample of patients who have cognitive/motor impairment will be randomized to an either Intervention or Control group.
~In the second phase of the trial, survivors in the Intervention Group will receive 6 sessions of cognitive and motor training during two weeks, and survivors in Control Group will undergo …..
~After this treatment phase, motor and cognitive functions assessment will be conducted in all patients once again.
~In the third phase, the Control Group will be provided the active intervention (i.e. 6 sessions of cognitive and motor training during two weeks), while the Intervention Group engages in passive reading.
~After this, motor and cognitive functions assessment will be carried out in all patients once again."
15861402|NCT03951220|Other|Diffusion Weighted Magnetic Resonance Imaging (DWMRI)|Using the expertise of the Oxford Centre For Clinical Magnetic Resonance Research (OCMR) for imaging protocol development, and the new Fine Structural Analysis (FSA, Osteotronix Ltd, formerly Acuitas Medical) bone density quantification MRI method (Rafferty et al 2016), we will test a single protocol which combines three emerging experimental imaging sequences into a simple, non-invasive whole body imaging protocol to quantify disease burden and bone disease. To our knowledge, this has never been done before; if shown to be feasible, such a method would have two important applications: to precisely guide commissioned therapies in the clinic, so improving patient management; and as an exciting, novel research tool for the longitudinal combined assessment of tumour burden and cancer-induced bone disease in response to therapy.
15861403|NCT03951220|Other|DXA scan|Used to assess bone density
15861404|NCT03951220|Other|Bloods and urine|Samples will be taken to assess bone biomarkers
15861405|NCT03951207|Drug|Rosuampin 10/5mg|Rosuvastatin 10mg/Amlodipine 5mg qd for 8 weeks
15861406|NCT03951207|Drug|Rosuampin 20/5mg|Rosuampin 20/5mg qd for 8 weeks
15861407|NCT03951207|Drug|Amlodipine/Atorvastatin 5/20mg|Amlodipine/Atorvastatin 5/20mg qd for 8 weeks
15861408|NCT03951194|Biological|Autologous Platelet Rich Plasma (PRP) intra ovarian infusion|Autologous PRP intra ovarian infusion
15861409|NCT03951194|Other|Placebo: Autologous Platelet Free Plasma (PFP) intra ovarian infusion|Autologous PFP intra ovarian infusion
15861410|NCT03951181|Behavioral|LEAP-MS|The LEAP-MS intervention is a co-produced, digital interactive education and activity tool, specifically developed for PwPMS. The tool includes multimedia education about being active with PMS, tailored physical activity ideas and interactive functions enabling the development of personalised activity programmes, goal setting and activity logs. The digital tool works in conjunction with support from trained physiotherapists. The feasibility study will evaluate how the LEAP-MS intervention can be used in practice.
15861411|NCT03951168|Behavioral|Routine Management|Routine Management Model of Health Education for diabetes Patient will receive the Routine Management Model of Health Education for Diabetes. After the patient was admitted to hospital, the responsible nurse carried on the diabetes health education for the patient. There are no regulations on the path and time of education. Interspersed with diabetes health education at work. Follow up 2 weeks with phone call after discharge. This is the current clinical model in hospital.
15861412|NCT03951168|Behavioral|Standardized Management|Standardized Management Model of Health Education for Diabetes The patients were educated by full-time diabetic education nurses according to diabetes education path. Including diabetes diet, exercise, drugs, hypoglycemia, diabetic foot, and so on. Telephone follow-up was performed at 2 weeks and 4 weeks after discharge and 12 and 24 weeks follow-up in diabetes education clinic. Develop telephone follow-up standardized content and implement telephone follow-up according to standardized content.Full-time education nurses carry on education according to diabetes mellitus health education path table.
15861413|NCT03951155|Behavioral|Muscle Relaxation|"Ask the child to lie down in a comfortable position. Ask him/her to notice how their muscles feel in each part of the body. Taking one area of the body at a time (face, shoulders, arms, hands, fingers, abdomen, legs, feet, and toes).
~Instruct the child to contract the muscles for 5 seconds, take a deep breath, and release.
~Next, instruct the child to contract all muscles simultaneously, hold for 5 seconds, then release.
~Finally, ask him/her to notice how his/her muscles feel after the exercise."
15861414|NCT03951142|Drug|Losartan|This trial is open-label; therefore, the participant, the trial site personnel, the Sponsor and/or designee are not blinded to treatment. Drug identity (name, strength) is included in the label text. Storage, handling and preparation requirements will be handled in concordance with the Pharmacy Manual for losartan.
15861415|NCT03951129|Procedure|hemodialysis catheter insertion|The State-Trait Anxiety Inventory (STAI) and Visual Analogue Scale (VAS) scoring will be performed after informing all groups and after the procedure
15861416|NCT03951116|Drug|FCN-437|FCN-437c is a selective and potent CDK4/6 dual inhibitor, with broad antitumor activity in preclinical pharmacology models, favorable physical and pharmacokinetic (PK) properties, and acceptable toxicity profile in nonclinical studies.
15861417|NCT03951103|Other|rFVIIIFc|Drug according to prescription
15861418|NCT03951090|Other|Results of the brief geriatric assessment|Providers will receive results of the brief geriatric assessment with recommendations for address deficits identified through the results of the brief geriatric assessment
15861419|NCT03951090|Other|No results of brief geriatric assessments|Providers will not receive results of the brief geriatric assessment. Participants will receive standard of care treatment
15861420|NCT03951077|Drug|Elagolix|Capsule administered orally
15861421|NCT03951077|Drug|Placebo|Capsule administered orally
15861490|NCT03950596|Behavioral|Background Questionnaire|Background questionnaire will be filled out by participants
15861422|NCT03951064|Device|Esophageal balloon|All patients in both groups will have an esophageal balloon catheter inserted by a research investigator. The catheter will be inserted into their nare while upright (head of bed >30 degrees) to a depth slightly more than the estimated distance from the lower sternum to the back of the ear (typically around 60 cm). Gastric positioning will be confirmed with abdominal compression testing and the catheter then retracted 10 - 20cm into the lower esophagus. Placement will be confirmed with the presence of cardiac oscillations on the esophageal probe. The probe will then be secured to the patient's nasal opening using tape.
15861423|NCT03951064|Procedure|Intervention Spontaneous Breathing Trial (SBT) and Extubation|Patients in the Intervention group will undergo an SBT regardless of their PEEP level. The PEEP that generates a Ptp of 0 will be considered their optimal PEEP, and this will not be lowered for the SBT. The Intervention Group SBT will consist of a trial of a pressure support of 5 cm H2O and Optimal PEEP.
15861424|NCT03951064|Procedure|Control Spontaneous Breathing Trial and Extubation|Patients in the Control group will undergo an SBT when they reach a PEEP ≤8 cm H2O. This is the current standard of care based on the SBT protocol at UNC Hospitals. SBT and extubation prior to meeting these criteria will be based on primary medical team's discretion and will be recorded for analysis and safety tracking.
15861425|NCT03951064|Procedure|Intervention Weaning after Tracheostomy|Based on the use of optimal PEEP in this group, and the experience in the previous study protocol, the investigators will place patients in the Intervention group on Tracheostomy Collar Trial ONLY with a speaking valve. This simulates the normal process of utilizing the upper airway to maintain lung inflation that is performed automatically when a patient does not have an artificial airway.
15861426|NCT03951064|Procedure|Control Weaning after Tracheostomy|The control group will be placed on Tracheostomy Collar Trial with no requirement for speaking valve. They may utilize a speaking valve if tolerated and desired, but there is no requirement as there is in the Intervention group.
15861427|NCT03951051|Drug|Olmesartan Medoxomil 40 mg|Olmesartan Medoxomil is manufactured by Pharmtechnology LLC, Republic of Belarus. Each film-coated tablet contains 40 mg of olmesartan medoxomil.
15861428|NCT03951051|Drug|Olmetec®|Olmetec® is manufactured by Daiichi Sankyo Europe GmbH, Germany. Each film-coated tablet contains 40 mg of olmesartan medoxomil.
15861429|NCT03951038|Procedure|PCIA group|The formula of the PCIA included tramadol 800 mg, flurbiprofen axetil 100mg with saline added up to a volume of 80 ml in total. The PCIA pump was set up with a 5 ml loading dose, a 2 ml bolus dose, a 15 min lockout interval and background infusion at a rate of 1 ml/h.
15861430|NCT03951038|Procedure|Lateral TLIPB group|"both sides of the spine, a single injection of ropivacaine by nerve stimulating needle under ultrasound-guided between the longissimus and iliocostalis muscles .
~The regimen of Lateral TLIPB group is0.2% 20ml ropivacaine and the regimen of PCIA is same with PCIA group."
15861431|NCT03951025|Dietary Supplement|Melatonin oral administration|One tablet with1 mg of melatonin and 82 mg of excipients
15861432|NCT03951025|Dietary Supplement|Melatonin sublingual administration|One tablet with 1 mg of melatonin and 82 mg of excipients
15861433|NCT03951012|Procedure|Blood draw|Participants will be approached during their regular clinic visits and asked if an extra tube of blood may be collected prior to the treatment. If consent is not obtained before this visit, a participant will be asked later in the same day. The amount of blood collected will be 2 teaspoons (10mL).
15861434|NCT03950999|Other|Placebo|Sugar pill
15861435|NCT03950986|Other|Modified clinical reminders|Clinical reminders for the vaccines of interest will be bundled into a single reminder, and other changes made to streamline the design and reduce provider burden. Other changes include an immunization dashboard that relays a patient's vaccination status and talking points for providers to use in their dialogues with patients.
15861436|NCT03950973|Behavioral|CareAvenue|CareAvenue is an e-health tool providing information about diabetes management and low-cost resources. Participants in this group have access to CareAvenue and receive a weekly automated phone call and text messages related to CareAvenue and its resources as well as diabetes management.
15861437|NCT03950973|Behavioral|Guest Assistance Program|The Guest Assistance Program (GAP) is a resource, which provides assistance with medical and non-medical needs and resources to patients receiving medical care at University of Michigan health system. Participants in this group are provided with GAP information and receive text messages related to diabetes management.
15861438|NCT03950960|Drug|BMS-986256|Specified dose on specified days
15861439|NCT03950960|Drug|Itraconazole|Specified dose on specified days
15861440|NCT03950947|Device|Amplatzer vascular plug|See above
15861441|NCT03950947|Other|Sham Controll|Angiography of the RIMA without occlusion
15861442|NCT03950934|Other|no intervention, observational study, perioperative survey|no intervention
15861443|NCT03950921|Behavioral|Patient Safety Display|Digital display of catheter and pressure injury information in patient hospital room
15861444|NCT03950908|Other|Single bite biopsy technique|During biopsy collection one specimen will be retrieved during a single passage of the biopsy forceps.
15861445|NCT03950908|Other|Double bite biopsy technique|During biopsy collection two specimens will be retrieved during a single passage of the biopsy forceps.
15861446|NCT03950882|Drug|PXL770|Oral capsule
15861447|NCT03950882|Drug|Placebo|Oral capsule
15861448|NCT03950869|Behavioral|Positive Expectation Manipulation|Participants are watching a video tape of a trauma expert who provides selective information on the development of intrusive memories. This video tape aims to increase positive expectations.
15861449|NCT03950869|Behavioral|Negative Expectation Manipulation|Participants are watching a video tape of a trauma expert who provides selective information on the development of intrusive memories. This video tape aims to increase negative expectations.
15861450|NCT03950856|Drug|V114|15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in each 0.5 mL dose.
15861451|NCT03950856|Drug|Prevnar 13™|13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F in each 0.5. mL dose.
15861452|NCT03950843|Drug|CKD-825|"Dosage Form: capsule
~Dosage: 3 types(low/medium/high dose)
~Frequency: QD(once daily) administration"
15861453|NCT03950843|Drug|Placebo oral capsule|"Placebo of CKD-825
~Dosage Form: capsule
~Dosage: NA
~Frequency: QD administration"
15861454|NCT03950830|Drug|Disulfiram|Disulfiram 400mg daily, continuously
15861455|NCT03950817|Drug|Nebulized Sub-dissociative Dose Ketamine at either 0.75 mg/kg|Nebulized Sub-dissociative Dose Ketamine at 0.75 mg/kg
15861456|NCT03950817|Drug|Nebulized Sub-dissociative Dose Ketamine at 1 mg/kg|Nebulized Sub-dissociative Dose Ketamine at either 0.75 mg/kg, 1 mg/kg, and 1.5 mg/kg.
15861457|NCT03950817|Drug|Nebulized Sub-dissociative Dose Ketamine at 1.5 mg/kg.|Nebulized Sub-dissociative Dose Ketamine at 1.5 mg/kg.
15861458|NCT03950804|Drug|Eculizumab Injection|Patients receive eculizumab as deemed necessary by the primary physician
15861459|NCT03950791|Behavioral|Pain Catastrophizing Class|A 2-hour class that will be delivered by a clinical psychologist to participant cohorts. Didactic content includes psychoeducation about opioid use, the risk for misuse, and opioid reduction education materials. It will also include mind-body science as it relates to pain and PC. Participants learn how to identify catastrophizing in the moment, and how to self-treat it. During the class, participants acquire skills and develop a plan to apply the learned skills to decrease physiological hyperarousal within the context of PC. Participants also acquire skills that improve the regulation of cognition and emotion, including PC reframing and thought restructuring, and develop a plan for implementing these skills in daily life. Finally, participants develop a plan to use behaviors that modulate attention and counteract helplessness.
15861460|NCT03950791|Behavioral|Health Education|Education about improving lifestyle factors to improve participants' overall health.
15861461|NCT03950778|Drug|Human albumin|Patients are divided into 2 groups by envelope randomization. In the treated group, albumin supplementation occurs up to a target of 30 g / l at the end of the test period at a maximum dose of 3 x 100 ml, and no albumin is added above the control value of 20 g / l. Patients with albumin below 20 g / l in the control group are excluded from the study and albumin supplemented. Blood samples are taken directly at the intensive care class, and at the same time on the following days. Urine was collected for 24 hours. The kinetics of the parameters are examined for five days.
15861462|NCT03950765|Behavioral|Ecological momentary intervention|Content of this intervention is based on pre-established transdiagnostic protocols for addressing the negative emotion associated with suicidal thoughts and behaviors.
15861463|NCT03950752|Combination Product|Optimized Bagel|Participants will eat 132g of a bagel with an optimized composition in fatty acids in only one day, representing an ingestion of 556.5 kcal and 33g of total fat, of which 4.41g are saturated fatty acids, 24.27g are monounsaturated fatty acids, and 4.28g are polyunsaturated fatty acids.
15861464|NCT03950752|Combination Product|Conventional Bagel|Participants will eat 132g of a bagel with a conventional composition in fatty acids in only one day, representing an ingestion of 589.0 kcal and 35.6g of total fat, of which 16.76g are saturated fatty acids, 13.00g are monounsaturated fatty acids, and 5.81g are polyunsaturated fatty acids
15861465|NCT03950739|Drug|Treprostinil Inhalation Powder|Treprostinil inhalation powder single-use cartridges containing either 32 or 48 micrograms of treprostinil per cartridge (QID)
15861466|NCT03950726|Procedure|ileocolic resection|Ileocolic resection through McBurney incision
15861467|NCT03950713|Behavioral|Mindfulness-based Stress Reduction Program - Taiwan (MBSR-T)|The MBSR-T is focused on strategies to manage diabetes distress for new residents by three new techniques. Firstly, it involves practicing body and meditation exercises for openness to the awareness and acceptance of transferred life experiences, such as mindful attention exercise, which is assumed to allow the residents to behave in a less reactive and more reflective manner when confronted with transferred life stressors. Second, mindfulness meditation techniques were provided for difficult thoughts and feelings related to diabetes, such as paying full attention to the present moment of life and choosing to respond skillfully rather than reacting automatically to external events, thoughts or emotions as they arise. Third, a specific topic, for example on how to be mindful when life style is changed, or how to pay attention to the present moment within Chinese culture of peacefulness was discussed in each session.
15861468|NCT03950700|Drug|Bupivacaine-epinephrine|BUPIROP® 0.5% ROPSOHN THERAPEUTICS S.A.S
15861469|NCT03950700|Drug|Saline Solution|Saline solution 0.9% (Baxter laboratories).
15861470|NCT03950687|Drug|Recombinant Human Erythropoiesis Injection (CHO cell)|rHuEPO is a recombinant human erythropoietin with the same biological effects as natural erythropoietin
15861471|NCT03950687|Drug|Recombinant Erythropoiesis Stimulating Protein Injection(CHO cell)|rESP is a high glucose medium and long-acting recombinant protein products, containing 165 amino acids by adding 3 glycosylation sites
15861472|NCT03950674|Biological|Pembrolizumab 200 mg|IV infusion
15861473|NCT03950674|Drug|Cisplatin|IV infusion
15861474|NCT03950674|Drug|Carboplatin|IV infusion
15861475|NCT03950674|Drug|Pemetrexed|IV infusion
15861476|NCT03950674|Dietary Supplement|Folic acid 350-1000 μg|Orally; at least 5 doses of folic acid must be taken during the 7 days preceding the first dose of pemetrexed, and folic acid dosing must continue during the full course of therapy and for 21 days after the last dose of pemetrexed.
15861477|NCT03950674|Dietary Supplement|Vitamin B12 1000 μg|Intramuscular injection in the week preceding the first dose of pemetrexed and once every 3 cycles thereafter. Subsequent vitamin B12 injections may be given the same day as pemetrexed administration.
15861478|NCT03950674|Drug|Dexamethasone 4 mg|For prophylaxis; orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.
15861479|NCT03950674|Drug|Saline solution|IV infusion
15861480|NCT03950661|Other|Walking|
15861481|NCT03950648|Behavioral|Spatial Cognitive Training|map reading and route-learning skills
15861482|NCT03950635|Dietary Supplement|Dietary Intervention|Consume whole-foods, fiber-rich diet
15861483|NCT03950635|Dietary Supplement|Dietary Intervention|Consume high fat, low carbohydrate (ketogenic) diet
15861484|NCT03950635|Other|Questionnaire Administration|Ancillary studies
15861485|NCT03950622|Biological|V114|15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F in each 0.5 mL dose.
15861486|NCT03950622|Biological|Prevnar 13®|13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F in each 0.5 mL dose.
15861489|NCT03950596|Other|Acute resistant load exercises|"Leg bench and leg press acute resistant load exercises
~Leg-bench and leg-press acute resistant load exercises"
15878652|NCT03815240|Other|Mepilex® Border Sacrum|adhesive sacrum dressing
15861491|NCT03950596|Other|Pain Questionnaire|Pain questionnaire regarding pain in the knee during previous 3 months
15861492|NCT03950596|Genetic|DNA and RNA test|DNA and RNA tests will be sent to a genetic laboratory for analysis
15861493|NCT03950596|Diagnostic Test|Ultrasound|Ultrasound of the knee joint and the quadriceps muscle and the pica tendon
15861494|NCT03950596|Diagnostic Test|Percutaneous Needle Core Biopsy|Core Biopsy will be taken from the quadriceps femoris muscle
15861495|NCT03950570|Drug|Abraxane|"The doses of ORIN1001 in both dose escalation and dose expansion will be 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600mg, 800 mg, 1,000 mg, 1,200 mg Weekly paclitaxel will be 80 mg/m2 given intravenously for the dose escalation and dose expansion phases.
~cohorts as follows: 100 mg, 200 mg, 400 mg, 600 mg, 800 mg, 1,000 mg, 1,300 mg and 1,500 mg administered for 21 days (one cycle)."
15861496|NCT03950544|Drug|Fosfomycin|Fosfomycin and meropenem
15861497|NCT03950544|Drug|Tigecycline|Tigecycline and meropenem
15861498|NCT03950544|Drug|Polymyxin B|Polymyxin B and meropenem
15861499|NCT03950531|Other|No intervention|
15861500|NCT03950518|Drug|Anlotinib Hydrochloride Capsules|Anlotinib Hydrochloride Capsules, 12mg/d
15861501|NCT03950518|Drug|Arginine hydrochloride|AHC,12mg/d AH,40g/d
15861502|NCT03950518|Drug|levamisole|AHC,12mg/d AH,40mg/d LM,150mg/d
15861503|NCT03950505|Drug|Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) treatment for 24 weeks|All participants will be treated with Nesinaact 25/15 (Alogliptin benzoate 25mg, pioglitazone hydrochloride 15mg) for 24 weeks. Patients who have not been prescribed any other anti-diabetic drugs at least for 12 weeks and whose HbA1c ranges from 6.5~8.5%, can be enrolled. If Patients has been prescribed metformin as monotherapy, they have to substitute metformin with nesinaact 25-15 for enrollment.
15861504|NCT03950492|Device|Deep Brain Simulator|This is an open-label, safety, tolerability, and feasibility study for participants who have treatment refractory OUD that are eligible to have DBS targeting the NAc/VC.
15861505|NCT03950479|Diagnostic Test|3D and 4D Transperineal Ultrasound|The evaluation of Pelvic Floor Muscles with 3D and 4D transperineal ultrasound using A Voluson E6 system (GE Healthcare, Zipf, Austria) with RAB 8-4-MHz volume transducer for all acquisitions. Measurements will be performed in axial planes. The levator hiatus area (LHA), the antero-posterior (AP) diameter and the left-right (LR) transverse diameter will be analyzed at rest, during pelvic floor contraction and on maximal Valsalva maneuver.
15861506|NCT03950453|Behavioral|Parenting Mindfully for Health Nutrition (PMH)|"PMH will include included the following components:
~mindfulness strategies as outlined in the MBSR manual,
~mindful parenting concepts,
~mindful eating and awareness of family choices;
~self and child monitoring of food intake, PA and emotional reactivity;
~utilizing mindfulness for emotion regulation and distress tolerance,
~behavioral strategies of goal setting and implementing increasing frequency of healthy food intake and physical activity (PA)"
15861507|NCT03950453|Behavioral|Contact Control Nutrition (C+N)|Contact Control Group where parents engage in a quiet, relaxing, but stimulating activity with stress reduction benefits.
15861508|NCT03950427|Behavioral|Videogame-based physical activity|videogame-based physical activity
15861509|NCT03950427|Behavioral|sedentary videogame|sedentary videogame
15861510|NCT03950427|Drug|Bupropion|Bupropion
15861511|NCT03950427|Behavioral|Counseling|Counseling for smoking cessation
15861512|NCT03950414|Biological|CMV specific T-cells|"Naturally occurring, allogeneic donor lymphocytes derived from a leukapheresis or a whole blood product, enriched for CMV-specific CD4+ and CD8+ T cells Suspension of CMV-specific T cells in 10 mL of 0.9% NaCl with 2% Human Serum Albumin(HSA) via IV bolus injection
~Low Dose Tier - Viral-Specific T cell infusion 5 x10^3 cells/kg body weight(BW)
~Mid Dose Tier - Viral-Specific T cell infusion 1.25 x10^4 cells/kg BW
~High Dose Tier - Viral-Specific T cell infusion 2.5 x10^4 cells/kg BW Product will be administered fresh intravenously to recipient within four hours of collection."
15861513|NCT03950401|Procedure|Monocryl|subcuticular Monocryl wound closure
15861514|NCT03950401|Procedure|Nylon|wound closure using nylon suture on the skin
15861515|NCT03950388|Behavioral|Intervention|Wards randomly assigned to receive the intervention will have a Band 8a Psychologist based on the ward for 0.5FTE for 7 months. During this time, all patients will be involved with the proposed stepped model of care intervention at one of three levels. The level the patient receives will be decided by the multidisciplinary ward team. At Step one, all patients will have a psychological formulation developed by the psychologist in conjunction with the patient or members of the ward team. At Step 2, all qualified nurses will be trained and supervised to deliver guided self-help material of psychological interventions targeting key problem areas for patients. At Step 3, patients will be offered up to 16, one-to-one therapy sessions with the psychologist.
15861516|NCT03950362|Drug|Avelumab|Administration of Avelumab 10mg/kg Infuse IV over 30-minutes: 1 cycle 5 days before External Beam RadioTherapy, then every 21 days x 8 cycles (6 months)
15861517|NCT03950362|Device|Radiotherapy|60-66 Gy in 30-33 Fractions (2 Gy/fractions) given to the whole bladder
15861518|NCT03950336|Dietary Supplement|Prebiotics|Oligofructose-enriched inulin [a combination of shorter chain oligofructose, Degree of Polymerisation (DP) 3 - 9 and longer chain inulin (DP ≥ 10), in a 50:50 ratio ± 10 %] 12 g/day for 12 weeks
15861519|NCT03950336|Other|Low n-6 PUFA Diet|The Mediterranean diet pattern (MDP) with increased n-3 PUFA, saturated fatty acids (SFA) and monounsaturated fatty acids (MUFA) and reduced n-6 PUFAs food intake will be adopted as suitable Low n-6 PUFA diet.
15861520|NCT03950336|Dietary Supplement|Maltodextrin|Maltodextrin consists of D-glucose units connected in chains of variable length (DP 3-17). The glucose units are primarily linked with α(1→4) glycosidic bonds. Maltodextrin is easily hydrolyzed by the intestinal enzymes and thus does not have an effect on colonic microbiota. Maltodextrin (12 g/days for 12 weeks) will be used as a placebo for the prebiotic treatment
15861521|NCT03950336|Other|Control Diet|"Participants who will not be assigned to Low n-6 PUFA diet will be advised to follow the Canada's Food Guide recommendations (Control diet). As Canada's Food Guide Diet is also designed with the aim to support healthy eating and prevention of metabolic and chronic disorders, this diet may not be considered as a true comparator for the Low n-6 PUFA diet intervention."
15861522|NCT03950323|Radiation|MRI with Facial nerve tractography|MRI with Facial nerve tractography in addition to T1 imaging, T1 gadolinium imaging and T2 imaging.
15861838|NCT03947697|Device|Neuromuscular Electrical Stimulation (Sensory)|Group will receive Electrical Stimulation up to sensory level
15861523|NCT03950310|Device|Excimer laser catheter|The excimer laser catheter is equipped with multiple optical fibers on the periphery of the guide wire lumen corresponding to 0.014 inch, which is used for the purpose of reperfusion of barrier site of coronary artery. The connector on the front side is connected with the CVX-300 laser generator, and the tip at the top contact directly with the lesion. The laser catheter consisting of multiple optical fibers transmits the energy in the ultraviolet region from the CVX300 laser generator to the blockage in the blood vessel. The ultraviolet energy is transmitted from the tip of laser catheter, transpires the fibrous, calcified and arteriosclerotic lesion by light, and enables reperfusion in the lesion. The laser catheter has appropriate hydrophilic coating and easily follows the inside of coronary artery.
15861524|NCT03950297|Drug|609A|609A is a recombinant anti-PD-1 humanized IgG4 kappa antibody that targets the human PD-1
15861525|NCT03950284|Device|immediate loading with all on four technique in FFF|All cases will undergo surgery under local regional anesthesia. Injection of local anaesthesia (Articaine 4% and 1:100000 epinephrine) for regional infiltration. Sequential drilling then insertion of the dental implant fixtures and abutments on which the prefabricated temporary prosthesis will be fixed.
15861526|NCT03950271|Drug|SHR-1210 Combined With Trastuzumab , Oxaliplatin and Capecitabine|"Neoadjuvant chemotherapy： SHR-1210 (200mg, d1, q3w) + trastuzumab ( 8 mg/kg on day 1 of the first cycle, followed by 6 mg/kg every 3 weeks) + capecitabine (1000mg/m2 bid d2-15, q3w) + Oxaliplatin (130mg/m2, d2, q3w)；4cycle
~postoperative adjuvant chemotherapy： Capecitabine (1000mg/m2 bid d1-14, q3w) + oxaliplatin (130mg/m2, d1, q3w)；The total number of chemotherapy cycles is 8 cycles."
15861527|NCT03950258|Procedure|endovascular embolization|Transarterial embolization is done for patients with arteriovenous shunts as via transfemoral access using flow-guided microcatheter and an embolic agent is injected.
15861528|NCT03950245|Other|Placebo|Four-hour liquid mixed meal tests and a subsequent ad libitum meal during saline infusion.
15861529|NCT03950245|Other|GLP-1 antagonism|Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin 9-39 and saline infusion.
15861530|NCT03950245|Other|GIP antagonism|Four-hour liquid mixed meal tests and a subsequent ad libitum meal during GIP(3-30) and saline infusion.
15861531|NCT03950245|Other|GLP-1 and GIP antagonism|Four-hour liquid mixed meal tests and a subsequent ad libitum meal during exendin and GIP(3-30) infusion.
15861533|NCT03950219|Other|Group course|Education and support
15861534|NCT03950206|Other|Indocyanine green angiography|Intravenous ICG (PULSION Medical Systems SE, Feldkirchen, Germany) will be used for the intraoperative evaluation of ureteral vascularization. Twenty-five milligrams of indocyanine green will be diluted in 10 ml of soluble water, and a bolus of 0.25 mg/Kg will be injected through a peripheral vein. During laparoscopy, a NIR camera-head (KARL STORZ Gesellschaft Mit Beschränkter Haftung&amp; Co., Tuttlingen, Germany) will be used to visualize the ureteral vascularization.
15861535|NCT03950193|Other|Questionnaires to evaluate psychic development of the child|Child Behaviour Checklist. This test, completed by parents and with 52 questions, is designed to screen children at high risk for emotional problems, mood disorders, anxiety, pervasive developmental problems, attention deficit and hyperactivity, antonymic reactions (oppostion, provocation) and sleep problems.
15861536|NCT03950180|Other|Prostate Cancer Comorbidity Index (PCCI) score|Life expectancy information
15861537|NCT03950154|Drug|Bevacizumab Injection [Avastin]|Bevacizumab injection
15861538|NCT03950154|Drug|Oxaliplatin|Oxaliplatin injection
15861539|NCT03950154|Drug|Capecitabine|Capecitabine oral agent
15861540|NCT03950154|Biological|PD1-T cells|PD1-T cells injection
15861541|NCT03950141|Drug|Apatinib and S-1|Combined with Apatinib (250mg qd po) and S-1 (40-60mg bid d1-14) as maintenance therapy in advanced HER-2 negatived GC
15861542|NCT03950128|Behavioral|Mindfulness-Based Skills Training (MBST)|"This intervention teaches students mindfulness-based skills to help manage their emotions when resolving conflict with their partners. The skills followed the ABCDE acronym. ABCDE stands for awareness, breathing, checking in with your feelings and thoughts, describing your experience, and expressing what you want to change. Students learned about the skills and had opportunities to practice them as well."
15861543|NCT03950128|Behavioral|Psychoeducational|This intervention is based on the Love is Not Abuse (LINA) Curriculum (Liz Claiborne Education Development Center (n.d.)). It was adapted to be given over the course of three 50-minute sessions. The selected materials covered (a) what dating abuse is, (b) the pattern of abuse and, (c) technology and dating abuse. The curriculum is interactive and includes handouts, activities, and discussion.
15861544|NCT03950115|Device|Intense Pulsed Light (IPL)|IPL therapy will be performed with the M22® (Lumenis, Dreieich, Germany). IPL treatment is going to be administered to the skin below the lower eyelid. Before treatment, the eyes will be protected with opaque goggles. Ultrasound gel is going to be applied to the patient's face from tragus to tragus including the nose in order to conduct the light, help to spread the energy evenly, and provide a degree of protection. The intensity of the IPL treatment will range from 9.8J/cm2 to 13J/cm2 according to Fitzpatrick Skin Type Grading.
15861545|NCT03950102|Radiation|SBRT|Radiation dose of 27.5-50Gy in 5 fractions over 5-14 days with a radical dose as high as achievable based on mean liver dose (MLD), while fulfilling the dose constraints of OARs
15861546|NCT03950089|Device|Optical Coherence Tomography Angiography (OCT-A)|Optical Coherence Tomography Angiography (OCT-A) images were acquired using an Spectral Domain Optical Coherence Tomography device (Cirrus High Definition OCT Model 5000 with Angioplex; Carl Zeiss Meditec, Dublin, California, USA). With an acquisition speed of 68,000 A-Scan per second, the OCT Microangiography Complex algorithm provided OCT-A information for three-dimensional (3D) flow reconstruction. At each visit, each subject underwent a 3 x 3 millimeter (mm) macular 3D cube acquisition in both eyes. FastTrac continuous eye tracking technology was employed to control for eye movements and minimize motion artefacts.
15861547|NCT03950076|Drug|Edoxaban|Edoxaban 60mg (or 30mg as determined by clinical criteria)
15861548|NCT03950076|Other|Non-anticoagulant medical therapy|Non-anticoagulant medical therapy as determined by the local investigator includes i) No antithrombotic therapy ii) Antiplatelet monotherapy, including de novo indication for antiplatelet monotherapy during course of the study
15861839|NCT03947697|Device|Neuromuscular Electrical Stimulation|Group will receive Electrical Stimulation up to maximum tolerable level
15861549|NCT03950050|Drug|Ambroxol|"Ambroxol Hydrochloride therapy will be dosed up to 600 mg/day divided to twice a day starting 150 mg for the first month, 300 mg for the following month and 600 mg for the following month.
~The study was conducted in accordance with the provisions of the Declaration of Helsinki, Good Clinical Practice guidelines, and local laws and regulations."
15861550|NCT03950037|Drug|Albendazole|Albendazole; 15 mg/k/d divided in two doses (morning and evening), for 30 days, with a ceiling in 1200 mg/d.
15861551|NCT03950024|Diagnostic Test|functional brain MRI|The functional brain MRI realized will be a examination with a resting sequence and a sequence during a movement imagination task. (knee bent)
15861552|NCT03950011|Procedure|Enhanced recovery after surgery program|Enhanced Recovery After Surgery Programs (ERP) includes multimodal approaches of perioperative patient's clinical pathways designed to achieve early recovery after surgery and a decreased length of hospital stay (LOS).
15861553|NCT03949998|Device|Dry Needling|Comparison between dry needling and/or manual therapy of the cervical region.
15861554|NCT03949998|Other|Manual Therapy|soft tissue release, cervical traction and/or cervical mobilization
15861555|NCT03949985|Other|Tests of biological hemostatic profile associated with contraceptives|Tests of biological hemostatic profile associated with contraceptives will be done before and after having stopped an estrogenic contraceptive (group 1) and during the non-use of an estrogenic contraceptive (group 2)
15861556|NCT03949972|Other|Biosampling|Biosampling at initial visit and follow-up visits
15861557|NCT03949959|Other|Multimodal physiotherapy|Participants will undertake their usual activities for the 5, 8 or 11 day baseline period following PRP. Participants will begin the 6 week intervention period following this period during which time they will participate in 10 sessions with an experienced postgraduate physiotherapist. After these 6-weeks, participants will have no contact with intervention personnel during the 6-week follow-up period.
15861558|NCT03949946|Procedure|Magnetic resonance imaging (MRI)|MRI scan uses radio waves in a magnetic field to obtain images of the breast. It is non-invasive and participants will not be exposed to harmful radiation. An image contrast agent will be used to enhance image clarity. Participants will be scanned lying face-down on a specially-designed bed and ear protectors will be provided to screen out background noise.
15861559|NCT03949933|Radiation|proton and carbon ion radiotherapy|proton and carbon ion radiotherapy
15861560|NCT03949920|Drug|Migalastat|Participants will be starting Migalastat as part of clinical care. Their initiation onto Migalastat is not determined by this study or it's protocol. Interventions as part of the study will be limited to the study investigations.
15861561|NCT03949907|Other|Nutritional counseling alone|"Nutritional counseling consists of a personalized dietary prescription (including sample meal plans and recipe suggestions) tailored on personal eating patterns and food preferences, in order to achieve estimated protein-calorie requirements and to take into account chewing and swallowing abilities. Regular consultation by a registered dietitian will be also provided every 10 days by means of face-to-face interviews (at scheduled follow-up visits - chemotherapy cycle) and telephone interviews (planned between chemotherapy cycles and as required by the patient). In the presence of significant reduction of normal food intake, the use of oral nutritional supplements will be also considered.
~In the presence of body weight loss >10% of the weight recorded at enrollment, patients allocated to this group group will be censored and treated according to current supportive care guidelines, including home parenteral nutrition."
15861562|NCT03949907|Other|Early supplemental parenteral nutrition plus nutritional counseling|"Patients will receive nutritional counseling in combination with systematic early supplemental home parenteral nutrition since diagnosis.
~Supplemental home parenteral nutrition will be prescribed, provided daily and adjusted throughout the study (approximately every 10 days, until the end of the scheduled first-line chemotherapy) according to estimated protein-calorie oral intakes, in order to satisfy estimated requirements. Home parenteral nutrition will be infused mainly during night hours, using multi-chamber bags containing olive oil-based lipid emulsions, when not contraindicated."
15861563|NCT03949894|Drug|Tolvaptan|30mg and 15mg of Tolvaptan Tablet
15861564|NCT03949881|Biological|FEMJA transplatation|The cultivated oral mucosal epithelium will be directly grafted onto the corneal stroma. The sheet is grafted without suture onto the exposed stromal bed after removal of the conjunctiva and fibrosis from the cornea. The grafted corneal surface is then covered with a soft permanent contact lens for protection during healing (between 3 to 15 days, according to tolerance) If the stroma appears opaque because of deep stromal scars a corneal allograft will be performed 12 months after FEMJA transplantation.
15861568|NCT03949855|Drug|Belimumab|"Belimumab is a recombinant, human, IgG1λ monoclonal antibody.
~Belimumab will be provided as a 200 mg sterile, liquid product in a prefilled syringe. Each syringe contains 1.0 mL of 200 mg/mL belimumab. Each syringe will be a single use.
~Standard Weekly dose: 200 mg. administered subcutaneously. A higher weekly dose, 400 mg weekly, per protocol and based on PK analysis, may be indicated for participants with high proteinuria."
15861569|NCT03949855|Drug|Placebo for Belimumab|"The placebo control will be provided as a sterile liquid product in a prefilled syringe. Each syringe will be of a single use.
~Standard weekly dose: 200 mg. administered subcutaneously. A higher weekly dose, 400 mg weekly, per protocol, may be indicated for participants with high proteinuria."
15861595|NCT03949673|Drug|Placebo|Matching Placebo will be administered in the parent study. Samples will be collected for participants who voluntarily elect to have knee or hip joint arthroplasty during the parent study
15861570|NCT03949855|Drug|Rituximab|"Rituximab is a monoclonal antibody with specificity for CD20, a transmembrane protein expressed on B cells from the pre-B to memory cell development stages.
~Rituximab is supplied at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-use vials for infusion. It is a clear, colorless liquid.
~Dose: 1000 mg intravenously (IV), Week 4 and -6."
15861571|NCT03949842|Drug|Inhaled corticosteroids/long-acting beta2-adrenergic/long-acting muscarinic receptor antagonists|A fixed dose of combination ICS/LABA plus LAMA once-daily was administered to COPD subjects using two separate non-ELLIPTA devices.
15861572|NCT03949842|Drug|Fluticasone furoate/umeclidinium/vilanterol|The first strip will contain FF at a dose strength of 100 mcg will be blended with lactose. The second strip will be contain UMEC and VI at a dose strength of 25 mcg and 62.5 mcg blended with lactose and magnesium stearate with respectively.
15861573|NCT03949829|Diagnostic Test|Cardiovascular CT|Cardiac and cardiovascular non-contrast and contrast CT
15861574|NCT03949816|Other|medical consultation: different doctor-patient-centered style of communication|Different doctor-patient communication
15861575|NCT03949816|Other|information letter / no medical consultation|In the control treatment participants receive all information about the herbal medical product in an information letter but have no contacted with the simulated doctor.
15861576|NCT03949803|Behavioral|Morning Chocolate Timing|During two consecutive weeks volunteers will eat chocolate within 1 hour of their habitual wake-time (100g).
15861577|NCT03949803|Behavioral|Evening Chocolate Timing|During two consecutive weeks volunteers will eat chocolate within 1 hours of habitual bedtime (100g).
15861578|NCT03949803|Behavioral|No Chocolate Timing|During two consecutive weeks volunteers will not eat chocolate.
15861579|NCT03949790|Procedure|ESPB and Intercostal nerve block|Erector spinae plane block + Intercostal nerve block
15861580|NCT03949790|Procedure|Intercostal nerve block|Intercostal nerve block
15861581|NCT03949777|Device|Aer-O-Scope Colonoscopy|resection or biopsy of colonic abnormalities for histopathalogical evaluation
15861582|NCT03949764|Drug|Sofosbuvir/velpatasvir (Epclusa®)|The protocol is intended to follow best practices/standard of care for the treatment of HCV, with additional allowances for the investigators to apply rigorous scientific practices for the research aspects of the study. While the treatment of HCV is fairly straightforward, less is known about treating active drug users and RNA-positive individuals in rural areas. We propose eight visits, including intake, four treatment-related visits, and three visits to determine re-infection (6- and 12-months post-SVR). Because determination of medication adherence and long-term reinfection rates are not part of standard clinical practice, the rural protocol developed at the conclusion of KeY Treat will be streamlined based on findings, consisting of five or fewer clinical contacts. The drug used for treatment is Epclusa®, a 12-week, once per day, pan-genotypic DAA with a favorable side effect profile. Vosevi® will also be available in cases where participants are non-responsive or are re-infected.
15861583|NCT03949751|Drug|Acne Crème Plus|The study specific intervention product is a combination of Benzoylperoxid and Miconazolnitrat (Widmer Acne Crème Plus, 47033 Swissmedic) to apply daily in the evening on the skin from the nipple-areola complex laterally to the medial margin of the scapula and from a horizontal line through the nipple-areola complex cranially over the shoulder and dorsally to the spina scapulae. The application should be done regularly for 7 days before shoulder surgery. The study specific intervention product is authorized by Swissmedic for use in the treatment of acne and is used standardly in clinical practice.
15861585|NCT03949725|Behavioral|Hans Kai Program|Participants in the Hans Kai program attend a health school to enhance their health knowledge and skills. Once complete, the participants form Hans Kai groups of 3 or more people, who meet on a monthly basis independently in a self-sustaining model, each meeting includes a group exercise activity, a group cooking activity, a group learning and discussion activity, and group monitoring of health biomarkers, such as blood pressure, waits circumference, and/or blood glucose.
15861586|NCT03949712|Device|Transcranial Static Magnetic Field Stimulation (tSMS)|tSMS consists of a small compact cylindrical neodynium magnet (S-45-30-N, Supermagnete) with an estimated strength of up to 0.5 Tesla and a size of 30 mm x 45 mm.
15861587|NCT03949712|Device|Sham Transcranial Static Magnetic Field Stimulation (tSMS)|Sham tSMS consists of a small compact metal cylinder, identical in appearance to the real tSMS device.
15861588|NCT03949699|Other|Resistance training|Participants will engage in strengthening exercises using a cable tower while seated. These movements will include trunk flexion and extension, diagonal trunk rotation, and lateral trunk flexion. The goal for resistance training frequency (Weeks 1-8) will be three times per week, lasting about 30-45 minutes per session including warm-up/cool-down, for a duration of eight weeks. Resistance intensity of each exercise will also be determined based on the initial maximal strength performing that exercise: Weeks 1-4 will be 50-60% of the baseline calculated 1 repetition maximum (RM) values; Weeks 5-8 will use resistive loads equivalent to 50-60% of Week 4 1RM calculations
15861589|NCT03949686|Drug|Saline Solution|0.5 ml/kg saline
15861590|NCT03949686|Drug|Bupivacaine|0.5 ml/kg %0.25 bupivacaine
15861591|NCT03949673|Drug|Fasinumab|Study drug will be administered in the parent study. Samples will be collected for participants who voluntarily elect to have knee or hip joint arthroplasty during the parent study
15861592|NCT03949673|Drug|Naproxen|Naproxen will be administered in the parent study. Samples will be collected for participants who voluntarily elect to have knee or hip joint arthroplasty during the parent study
15861593|NCT03949673|Drug|Diclofenac|Diclofenac will be administered in the parent study. Samples will be collected for participants who voluntarily elect to have knee or hip joint arthroplasty during the parent study
15861594|NCT03949673|Drug|Celecoxib|Celecoxib will be administered in the parent study. Samples will be collected for participants who voluntarily elect to have knee or hip joint arthroplasty during the parent study
15861840|NCT03947697|Other|Resistance Training|Group will receive exercise training.
15861596|NCT03949660|Device|Stimulation for blood pressure without stand|Consists of 80 daily training sessions using epidural stimulation optimized for blood pressure for up to 6 hours of stimulation a day.
15861597|NCT03949660|Device|Stimulation for blood pressure with stand|Consists of 80 daily sessions similar to the 1st intervention (without stand) plus 2 hours of epidural stimulation optimized for stand training.
15861598|NCT03949660|Device|Stimulation for trunk and core without stand|Consists of 80 daily training sessions using epidural stimulation optimized for trunk/core/voluntary function for up to 6 hours of stimulation a day.
15861599|NCT03949660|Device|Stimulation for trunk or core with stand|Consists of 80 daily sessions similar to the 1st intervention (without stand) plus 2 hours of epidural stimulation optimized for stand training.
15861600|NCT03949634|Drug|PLD|pegylated liposomal doxorubicin is 35 mg/m2 intravenously on Days 1 of each 21-day cycle followed by cyclophosphamide.
15861601|NCT03949634|Drug|CTX|cyclophosphamide is 600 mg/m2 intravenously on Days 1 of each 21-day cycle, followed by docetaxel or paclitaxel.
15861602|NCT03949634|Drug|Docetaxel|docetaxel is 100 mg/m2 intravenously on Days 1 of each 21-day cycle.
15861603|NCT03949634|Drug|Paclitaxel|paclitaxel is 80mg/m2 intravenously on Days 1, 8 and 15 of each 21-day cycle.
15861604|NCT03949634|Drug|Doxorubicin|doxorubicin is 60 mg/m2 intravenously on Days 1 of each 21-day cycle followed by cyclophosphamide.
15861605|NCT03949621|Drug|Vedolizumab SC|Vedolizumab SC liquid.
15861606|NCT03949608|Other|E-learning|"The intervention consists of the presentation and installation of an internet tool to educate the patient about his heart condition and about his medications in addition to usual care. The tool is an interactive web-hosting video called Mon Coeur, mon BASIC adaptable to smartphones and tablets. The total length of the video is around 15 minutes. The e-learning is interactive because of the possibility to click in the video to have more details about a particular point. The tool includes a part about the heart and particularly about the ACS (physiopathology, diagnosis, coronarography, angioplasty). A second part includes an education about the medications prescribed. The patient will select the medication being prescribed and receive information about it."
15861607|NCT03949595|Other|Data collection|
15861608|NCT03949582|Other|Test food containing different types of dietary protein|"The test foods will be (in six study visits):
~Soy mince/soup Chicken mince/soup Quorn mince/soup Soy mince/soup with guar gum Chicken mince/soup with guar gum Quorn mince/soup with guar gum"
15861609|NCT03949569|Behavioral|Therapy Dog|Children will undergo a 5 minute unstructured session with either a certified therapy dog or with a dog who is trained and certified for animal-assisted interventions and/or animal-assisted activities. Children will be allowed to talk to, pet, and play with the therapy dog during the interaction.
15861610|NCT03949569|Behavioral|Stuffed Toy Dog|Children will undergo a 5 minute unstructured session with a stuffed toy dog. Children will be allowed to talk to, pet, and play with the stuffed toy dog during the interaction.
15861611|NCT03949556|Other|Videos and/or SMS|Participants assigned to one of the intervention programmes will watch videos on a website for two months then will receive SMSs for four months.
15861612|NCT03949543|Other|Large Lunch Intervention|Participants were asked to consume 60% of their daily energy requirements as lunch, between 12:30 and 13:30. Breakfast accounted for 15% of their total daily energy, a morning and evening snack for 5%. 15% was given for light meal either as dinner.
15861613|NCT03949543|Other|Large Dinner Intervention|Participants were asked to consume 60% of their daily energy requirements as dinner, between 19:30 and 20:30, each day during their two dietary interventions. Breakfast accounted for 15% of their total daily energy, a morning and evening snack for 5%. 15% was given for light meal either as lunch.
15861614|NCT03949530|Drug|IDL-2965 Oral Capsule|Investigational drug
15861615|NCT03949530|Drug|Placebos|Placebo
15861616|NCT03949517|Drug|68-Ga RM2|Radioactive agent
15861617|NCT03949517|Drug|68-Ga PSMA11|Radioactive agent
15861618|NCT03949517|Device|Investigational software and coils in PET/MR Scan|Investigational software and coils in PET/MR Scan by General Electric Healthcare
15861619|NCT03949517|Procedure|PET/MRI|Positron emission tomography (PET)/Magnetic resonance imaging (MRI) Scan
15861620|NCT03949504|Procedure|New Find-risk questionnaire software|FINDrisk: software with 12 questions to define the risk of diabetes in the general population MyStar Connect: software to guide the diagnosis and the management of diabetes and its complications
15861621|NCT03949491|Procedure|3D medical models|Using 3D medical models of the abdomen, a virtual plan will assist reconstruction to clearly define and 3D model the normal and aberrant vascular anatomy of the donor site in order to decrease both operative time and dissection time. This will also allow for the proposal of incision lines to match the corresponding volumetric analysis of the transposed tissue in order to facilitate the creation of a patient specific tailored flap, which will improve the aesthetic outcomes, decrease donor site complications and improve patient satisfaction
15861622|NCT03949478|Drug|Ibuprofen|Ibuprofen to be prepared in a tablet that is not distinguishable from nifedipine or placebo tablet.
15861623|NCT03949478|Drug|Nifedipine|Nifedipine to be prepared in a tablet that is not distinguishable from ibuprofen or placebo tablet.
15861624|NCT03949478|Drug|Placebo|Sugar pill to be prepared in a tablet that is not distinguishable from ibuprofen or nifedipine tablet.
15861625|NCT03949465|Device|Transcranial Magnetic Stimulator|Repetitive Transcranial magnetic stimulation (rTMS) will be delivered using a MagPro X100 device with B70 coil and the intermittent theta burst (iTBS) protocol to the left dorsolateral prefrontal cortex. Participants will receive daily treatments (Monday-Friday) over four weeks
15861626|NCT03949452|Other|Subcostal Transversus Abdominis Plane catheter|"Prior to surgery, an ultrasound guided unilateral Subcostal Transversus abdominis plane bolus dose (consisting of amixture of 10 ml bupivaccaine 0.5% plus 100 mg magnesium sulphate to be completed by normal saline to a total volume of 20 ml mixture) will be given on the same side of the surgical incision.
~At the end of surgery, A Transversus abdominis plane catheter will be inserted unilaterally by surgeon during wound closure. Then postoperatively, Transversus abdominis plane infusion of a solution mixture prepared in multiple 50 cm syringes each syringe contain 20 ml bupivacaine 0.5% plus 100 mg magnesium sulphate to be balanced by normal saline to 50 ml solution mixture ( final concentration of bupivacaine is 0.2%). This solution mixture will be infused through Transversus abdominis plane catheter at a rate of 6 ml/hour for 72 hours postoperatively."
15862311|NCT03943901|Biological|Pegfilgrastim|Granulocyte stimulating factor, biologic response modifier
15861627|NCT03949452|Other|Epidural catheter|"Prior to surgery, we will site an epidural catheter in the thoracic T7-T9 region, and inject an epidural bolus dose same as described above (consisting of amixture of 10 ml bupivaccaine 0.5% plus 100 mg magnesium sulphate to be completed by normal saline to a total volume of 20 ml mixture) for intra operative analgesia.
~Postoperatively, patients will receive epidural infusion of the solution mixture (same as described above) prepared in multiple 50 cm syringes each syringe contain 20 ml bupivaccaine 0.5% plus 100 mg magnesium sulphate to be balanced by normal saline to 50 ml solution mixture ( final concentration of bupivaccaine is 0.2%). This solution mixture will be infused epidurally at a rate of 6 ml/hour for 72 hours (3 days) postoperatively."
15861628|NCT03949439|Procedure|Elective Cardiac Surgery|Surgical interventions (coronary artery bypass [CAB], valve replacement or valve repair).
15861629|NCT03949426|Drug|KPG-818|KPG-818 Capsules (1 mg, 5 mg and 20 mg) for oral administration is the drug substance powder filled in capsule (PIC) dosage form. KPG-818 Capsules and placebo capsules are packaged in HDPE bottle capped with HDPE cap.
15861630|NCT03949413|Diagnostic Test|Pediatric balance scale.|"The Pediatric Balance Scale (PBS) includes fourteen items. Each item of subsets scored as 4, 3, 2, 1 or 0. Finally, the total test score was calculated.
~Each child in both groups was examined individually, using ADHD Rating Scale-IV checklist. The child's teacher was asked to write the checklist. Then the therapist interpreted the total scores obtained from the checklist and she converted it to the percentile scores based on their total scores."
15861631|NCT03949400|Other|Exercise therapy and education.|Exercise therapy and education, physiotherapy rehab at Aalborg Municipality
15861632|NCT03949387|Other|FES Cycling Exercise|FES cycling will use self-adhering surface electrodes (Pals Platinum, Fallbrook, CA) placed over the quadriceps, hamstrings, and gluteal muscle groups to deliver stimulation to the leg muscles.
15861633|NCT03949387|Other|Passive Leg Cycling|Passive leg cycling will not involve electrical stimulation
15861634|NCT03949374|Drug|CRESTOR, reference formulation of rosuvastatin|Use of ROVASRO for hypercholesterolemia
15861635|NCT03949374|Drug|ROVASRO, generic formulation of rosuvastatin|Use of CRESTOR for hypercholesterolemia
15861636|NCT03949361|Diagnostic Test|Indirect calorimetry|Resting energy expenditure
15861637|NCT03949361|Diagnostic Test|Skin Temperature|Temperature: supraclavicular, infraclavicular, abdominal, mid-thigh, non-dominant lower arm, middle finger tip, left lower leg, left dorsal foot, ear thermometer
15861638|NCT03949361|Diagnostic Test|Dual energy X-ray Absorptiometry (DXA)|Body composition
15861639|NCT03949361|Diagnostic Test|Blood Sampling|thyroid-stimulating hormone (TSH), free triiodothyronine (fT3), free thyroxine (fT4), HbA1c, Fibroblast growth factor 21 (FGF21)
15861640|NCT03949361|Diagnostic Test|FDG-PET|Dynamic PET scanning of the neck-region
15861641|NCT03949361|Diagnostic Test|Capillary glucose|Prior to fluorodeoxyglucose (FDG)-PET in order to avoid hyperglycemia
15861642|NCT03949361|Diagnostic Test|Biopsy of supraclavicular adipose tissue (optional)|Ultrasound guided biopsy of the supraclavicular adipose tissue
15861643|NCT03949348|Procedure|Mid-urethral sling placement using autologous rectus fascia|Mid-urethral sling placement using autologous rectus fascia
15861644|NCT03949348|Procedure|Mid-urethral sling placement using synthetic mesh|Mid-urethral sling placement using synthetic mesh
15861645|NCT03949335|Device|IOL Model ZFR00V|Bilateral implantation with Investigational IOL Model ZFR00V
15861646|NCT03949335|Device|IOL Model ZCB00|Bilateral Implantation with control IOL Model ZCB00
15861647|NCT03949322|Behavioral|Adapted Physical Activity Program|The sessions in this program are similar to the adapted physical activity sessions already offered by sports therapy practitioners. This is an aerobic exercise session, with Nordic walking, and a combined session of muscle building and breathing exercises.
15861648|NCT03949309|Other|Exploring health literacy levels and patients' informal needs or individual relationship between caregivers and patients.|It is a cross-sectional study coupled with a qualitative ancillary study conducted within patients hospitalized for one of the two acute cardiovascular diseases (acute coronary syndrome or acute heart failure). All patients hospitalized at Hospices Civils de Lyon for one of these two diseases and whom are going back home will be enrolled. Few patients will be interviewed during the follow-up visit at 1-month post hospitalisation. Caregivers from cardiology units will also be interviewed.
15861649|NCT03949296|Behavioral|Mindfulness Intervention|"10-session program
~Introduction to mindfulness and its potential benefits
~Introduction to mindful practices and yoga poses
~Conditioned reactions to stress; integrating mindfulness into everyday life
~Challenges and insights gained in practicing mindfulness
~Using mindfulness to observe and reduce negative means of reacting to stress, and find more effective responses
~Reacting vs. responding to stressors
~Self-regulation and coping with stressors and communication challenges
~Fostering continuity of moment-to-moment awareness while practicing different forms of mindfulness
~Choosing and creating one's own blend of mindfulness practices
~Maintaining momentum to practice mindfulness once the program ends"
15861650|NCT03949296|Behavioral|Sleep Hygiene|"Session includes a handout with15 sleep hygiene tips:
~Maintain a regular sleep pattern
~Only try to sleep when feeling tired or sleepy
~If unable to sleep, do something calm until feeling tired and returning to bed
~Avoid caffeine & nicotine for 4-6 hours before going to bed
~Avoid alcohol for 4-6 hours before going to bed
~Use the bed only for sleeping and sex
~Avoid naps during the day
~Develop rituals to get relaxed and ready to sleep
~Try a hot bath prior to bedtime
~Avoid checking the clock during the night
~Use a sleep diary for a few weeks to track progress
~Avoid strenuous exercise before bedtime
~Avoid a heavy meal before bedtime
~Create a sleep environment that is quiet, comfortable, and dark
~Maintain a regular daytime routine"
15861869|NCT03947450|Biological|Placebo|The site or whole stump will be injected medium only without autologous skin fibroblasts
15861870|NCT03947437|Biological|LEP-F1 + GLA-SE|Leprosy antigen formulated with an adjuvant.
15861653|NCT03949270|Behavioral|BETA-Text text messaging intervention|Patients in the text messaging arm will receive daily, weekly, and monthly text messages. The daily message asks whether or not the patient has taken their breast cancer medication. The weekly message asks about any side effects and their severity. The monthly text message asks about any barriers that the patient might be experiencing. Concerning responses to any of the text messages will prompt contact from the office of the treating physician.
15861654|NCT03949257|Device|colonic transendoscopic enteral tubing|Colonic transendoscopic enteral tubing (TET) is a novel, safe, convenient, and reliable way for fecal microbiota transplantation (FMT) and the whole-colon enema treatment.
15861655|NCT03949244|Drug|Latanoprost 0.005%|Latanoprost 0.005% will be applied to the nailfold and images of the blood flow in the nailfold capillaries will be acquired.
15861656|NCT03949244|Drug|Latanoprost bunod 0.024%|Latanoprost bunod 0.024% will be applied to the nailfold and images of the blood flow in the nailfold capillaries will be acquired.
15861657|NCT03949244|Drug|Normal saline 0.9%|Normal saline 0.9% will be applied to the nailfold and images of the blood flow in the nailfold capillaries will be acquired.
15861658|NCT03949244|Diagnostic Test|Nailfold capillaroscopy|An imaging system and does not penetrate the skin. A video camera with a magnifying lens used for studying the movement of blood in small blood vessels at the nailfold of the 4th finger.
15861659|NCT03949231|Drug|PD1/PDL1 inhibitor|Infusion of PD1/PDL1 inhibitor through peripheral vein or hepatic artery.
15861660|NCT03949205|Other|Leg Extension Isometric Training|The leg extension isometric exercise will be performed tree times a week , in four 2 min bouts of isometric contraction, at a intensity of 30% of maximal voluntary contraction and an interval of two minutes between bouts.
15861661|NCT03949179|Device|The Low Back Pain and Disability Drivers Management (PDDM) model|The Low Back Pain and Disability Drivers Management (PDDM) model aims to identify the domains influencing pain and disability to guide clinical decisions. The model is composed of five domains upon which the clinician can base his assessment and orientate treatment allocation and includes: 1) nociceptive pain drivers (i.e., somatic, inflammatory or mixed pain), 2) nervous system dysfunction (NSD) drivers (i.e., sensitization of the peripheral and/or central nervous system), 3) comorbidity drivers (i.e., physical and/or mental health comorbidities), 4) cognitive-emotional drivers (i.e., maladaptive cognitions and/or behaviors) and 5) contextual drivers (i.e., occupational-related and social environmental contextual drivers). This profiling will inform and lead the clinician's treatment approach based on the combined contribution of each domain driving the experience of pain and disability.
15861662|NCT03949166|Other|food during labor and delivery|The food that will be allowed during labor and delivery was approved by the anesthesia team. It includes - fruits, energy bars, yogurt,
15861663|NCT03949153|Drug|Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]|Single Nivolumab 240 mg infusion at D0
15861664|NCT03949153|Procedure|Cryotherapy|Cryotherapy using interventional radiology of metastatic lymphadenopathy at D1
15861665|NCT03949153|Drug|Ipilimumab Injection|In situ injection with ipilimumab at D2.
15861667|NCT03949127|Other|Exercise Group|The group who will meet a physiotherapist who will show them strengthening and stretching muscles associated with pelvic tilt.
15861668|NCT03949114|Behavioral|Evaluation|Evaluate a weak debilitating phenotype screening on the patients before surgery;
15861669|NCT03949114|Behavioral|nursing care|Traditional post-operative nursing care
15861670|NCT03949114|Behavioral|rehabilitation|"Postoperative vital signs were stabilized for 2 hours and then assisted to turn over; 2 to 3 hours to change position, awake without swallowing dysfunction, to fluid diet; 6 hours later, raise the bed 15 to 30 °, eat a half-flow diet.
~On the first day after surgery, raise the bed 45 °, row and position training; catheter clamping training; assessment of pain, preventive analgesia. Early rehabilitation training was performed for 60 minutes each time for 5 consecutive days."
15861671|NCT03949101|Drug|Atropine Sulfate 1 % Ophthalmic Ointment and Atropine Sulfate 0.01% Eye Drop|use one drop into subconjunctiva
15861672|NCT03949101|Drug|atropine 0.01% eye drop|use one drop into subconjunctiva
15861673|NCT03949088|Other|UF and Na profiling|Modulation of UF and dialysate sodium
15861674|NCT03949075|Drug|Enalapril|Participants will be assigned to daily administration of ACE inhibitors (Initially 5 mg Corodil® 'Enalapril' daily followed by up to 20 mg daily dependent on the blood pressure response) combined with an 8-week training period.
15861675|NCT03949075|Drug|Placebo|Participants will be assigned to daily administration of placebo (5-20 mg CaCO3) combined with an 8-week training period.
15861676|NCT03949062|Drug|Ibrutinib|Ibrutinib 560mg per day administered orally on Day 1-21 of each 21-day cycle for 6 cycles
15861677|NCT03949062|Drug|Lenalidomide|Lenalidomide 25mg per day administered orally on Day 1-10 of each 21-day cycle for 6 cycles
15861678|NCT03949062|Drug|Rituximab|Rituximab 375mg/m2 per day administered intraveneously on Day 1 of each 21-day cycle for 6 cycles
15861679|NCT03949049|Drug|Citicoline|Citacoline as neuroprotector
15861680|NCT03949049|Other|Placebo|placebo group
15861743|NCT03948529|Drug|eltrombopag|eltrombopag at the starting dose of 50mg/day. After 2 weeks of eltrombopag initiation and in the absence of platelet response, eltrombopag will be increased every two weeks (50mg increase) up to a maximum dose of 150mg/day (2 maximum escalation from D1, with maximum dose escalation phase of 4 weeks).
15861871|NCT03947437|Biological|Placebo|Sterile normal saline for injection.
15861683|NCT03949023|Procedure|Standard of Care Cerebral Angiogram Group|"Subjects will undergo the standard of care cerebral angiogram and any intervention(s) (when applicable) that were discussed with their provider, following the standard procedural protocol for the procedure at WFBMC. There are no additional interventions or changes to the planned intervention(s) that will take place by agreeing to participate in the study.
~The data collected from this procedure, following the standard of care protocol, will include the following: force of injection of contrast material for each angiographic run (peak pressure associated with injection, duration of peak, and area under pressure curve), volume of contrast utilized, images from the procedure, measurements of vessel diameter at defined distances from the catheter tip utilizing the images, catheter type, any additional device(s) (when applicable) utilized during the procedure, and if spasmolytic agents are utilized (including dose and time of administration)."
15861684|NCT03949010|Other|Kinesiotaping with space correction technique|Kinesiotaping with space correction technique twice per week for two weeks along with home exercise program
15861685|NCT03949010|Other|Kinesiotaping with muscle inhibition technique|Kinesiotaping with muscle inhibition technique twice per week for two weeks along with home exercise program
15861686|NCT03949010|Other|Home exercise program|Home exercise program which consists of stretching exercises towards neck area
15861687|NCT03948997|Radiation|Pulsed dye laser (PDL)|Pulsed dye laser (PDL, 595nm) is effective for vasodilatory diseases, especially for the superficial to middle layers of the dermis
15861688|NCT03948984|Behavioral|Therapeutic Music Session|The 20 minute therapeutic music session will consist of classical music performed by a pianist with or without flute accompaniment with an individual patient's ICU room.
15861689|NCT03948971|Procedure|Venogram|The 5 French (5F) diagnostic catheter will be navigated into the inferior then superior vena cava and then into the internal jugular bulb on the dominant venous side (as determined from the arteriographic images). Next, a 0.027 inch microcatheter will be navigated using fluoroscopic guidance into the superior sagittal sinus and a venogram will then performed by injecting a small dose of contrast. Next, the venous sinus pressure waveforms will be recorded as the catheter is withdrawn into the jugular bulb and then in the superior vena cava to obtain a central venous pressure. Once completed, the catheters will be removed and the sheaths will be removed. Manual pressure will be held at the venous access site for a few minutes. The arterial sheath will be closed based upon standard arteriogram protocol.
15861690|NCT03948958|Other|Evaluation of the catheter function|Catheter function will be measured by the CINAS (Catheter injection and aspiration classification)
15861691|NCT03948958|Other|Catheter tip location, thrombus, sleeve and device damage visualization|Catheter tip location, thrombus, sleeve and device damage will be visualized by linogram
15861692|NCT03948958|Other|Catheter-related colonization|TIVAD colonization will be investigated by microbiological culture of the tip and chamber content
15861693|NCT03948958|Other|patient-reported outcome measures (PROM) related to the presence of the TIVAD|PROM will evaluate patient's experiences regarding the TIVAD insertion, dwell time, and removal using the Leuven Patient Reported Experiences at Port removal (Leuven PREP) questionnaire.
15861694|NCT03948958|Other|Macroscopic evaluation of the port chamber and catheter|Macroscopic evaluation of the port chamber and catheter will be performed after port removal.
15861695|NCT03948945|Radiation|Profile HaloTM Mixed Fractional Laser|Profile HaloTM fractional laser is the world's first hand tool with nonablative and ablative fractional laser. It includes a nonablative fractional laser with a wavelength of 1470 nm and an ablative fractional laser with a wavelength of 2940 nm. It has a good therapeutic effect on skin aging.
15861696|NCT03948932|Device|Transvaginal sonography|Measurement of cervical length via transvaginal sonography prior to labor induction.
15861697|NCT03948932|Device|Pressure watch|Measurement of inflation pressure in a cervical ripening balloon is PSI units.
15861698|NCT03948919|Drug|Fecal microbiota|Lyophilized encapsulated fecal microbiota given daily for 8 weeks.
15861699|NCT03948919|Other|Placebo|Placebo capsules identical in appearance to fecal microbiota capsules to be taken daily for 8 weeks.
15861700|NCT03948893|Behavioral|Mindfulness-Oriented Recovery Enhancement (MORE)|MORE is a behavioral therapy that integrates mindfulness training to modify reward processes.
15861701|NCT03948893|Behavioral|Cognitive Behavioral Therapy (CBT)|CBT is a therapy designed to help individuals understand how their thoughts and feelings influence their behaviors.
15861702|NCT03948867|Drug|Hydroxyurea|Hydroxyurea treatment will be provided to reduce stroke risk. Hydroxyurea treatment will be started at a fixed dose of 20.0 ± 5.0 mg/kg/day, followed by escalation to maximum tolerated dose (MTD).
15861703|NCT03948867|Diagnostic Test|Elevated Arm TCD Examination|"TCD examination on children with SCA between ages 2 and 16 years of age will be completed to evaluate their risk of stroke.
~For children with elevated velocities at initial screening or at 1 Year who receive hydroxyurea therapy, TCD examinations will occur every 6 ± 2 months."
15861704|NCT03948867|Diagnostic Test|Normal Arm TCD Examination|TCD examination on children with SCA between ages 2 and 16 years of age will be completed to evaluate their risk of stroke. TCD examination for all participants will occur at initial screening, at Year 1 (12 ± 3 months), and Year 2 (24 ± 3 months). Children with normal TCD velocities at initial screening will undergo repeat TCD 12 months after enrolment. If the TCD at 12 months has changed to an elevated velocity (conditional or abnormal), the child can begin study treatment (Hydroxyurea).
15861705|NCT03948854|Other|Registered dietitian|Education on low FODMAP diet is provided in person by a registered dietitian who is an expert on the low FODMAP diet
15861706|NCT03948854|Other|On-line video program|Education on low FODMAP diet is provided by an on-line program via a link sent through email
15861707|NCT03948854|Other|Printed handout|Education on low FODMAP diet is provided through printed handout material at the initial visit.
15861708|NCT03948854|Other|Dietitian-led group|Education on low FODMAP diet is provided in a dietitian-led group setting
15861709|NCT03948841|Other|magnetic resonance imaging|
15861710|NCT03948828|Biological|Autologous NK cell therapy|After conventional treatment, the patients were treated with autologous NK cells.
15861711|NCT03948828|Drug|GnRHa combained with reverse addition therapy|Postoperative patients were treated with GnRHa combined with reverse addition treatment.
15861808|NCT03948035|Other|autologous stem cell transplant|autologous stem cell transplant
15861809|NCT03948022|Drug|Dydrogesterone 10Mg Tablet (duphaston)|40 mg daily oral tablets
15861712|NCT03948815|Other|interventional birthing room|The design of the room is based on scientific evidence on the healthcare environment in general, and on a systematic review on the effect of birthing rooms published by the investigators, and interviews with women early after birth in Sweden. The room has a large birthing pool, several lighting options with dimming function, 40 mm suspended sound absorber in the ceiling, media installation covering two walls, which offers a choice of six different programmed nature scenes with light, sound effect and Music.
15861713|NCT03948802|Diagnostic Test|Interleukine 33 test in blood plasma|ELISA test for Interleukin 33
15861714|NCT03948789|Procedure|Magnetic Resonance Imaging-controlled high-focussed ultrasound therapy|Magnetic Resonance Imaging-controlled high-focussed ultrasound
15861715|NCT03948789|Procedure|Myomectomy (laparoscopic or open surgical)|Myomectomy (laparoscopic or open surgical)
15861716|NCT03948776|Diagnostic Test|BodyMetrix body composition ultrasound|Investigators will make ultrasound measurements of fat and muscle thickness at 7 positions on the arm, chest wall, and leg (subject's dominant side) using the BodyMetrix BX 2000 ultrasound machine. Clear ultrasound gel will be applied to the skin, a probe placed against the skin, and the fat/muscle thickness measurement made five times at each position. The gel is then wiped away. The images are analyzed by the BodyView Software and estimations of fat and muscle mass calculated. These will be compared to the reference technique of whole-body DXA imaging.
15861717|NCT03948776|Diagnostic Test|BodyMetrix body composition ultrasound only|Investigators will make ultrasound measurements of fat and muscle thickness at 7 positions on the arm, chest wall, and leg (subject's dominant side) using the BodyMetrix BX 2000 ultrasound machine. Clear ultrasound gel will be applied to the skin, a probe placed against the skin, and the fat/muscle thickness measurement made five times at each position. The gel is then wiped away. The images are analyzed by the BodyView Software and estimations of fat and muscle mass calculated. For inpatients currently admitted to the hospital, whole-body DXA imaging cannot be performed, as so the only assessment of body composition will be with the ultrasound.
15861720|NCT03948750|Procedure|Aqueous humour sampling|Aqueous humour sampling with Goldman-Witmer coefficient and immunoblotting
15861721|NCT03948737|Drug|Alpha-Tocopherol|all of the subjects in the alpha-tocopherol group received alpha-tocopherol orally, doses adjusted by age for 4 weeks of treatment.
15861722|NCT03948737|Drug|Placebo oral tablet|
15861723|NCT03948724|Behavioral|Therapeutic education program|Patient follow sessions the therapeutic patient education with manual therapy, therapeutic education, therapeutic exercize
15861724|NCT03948724|Behavioral|Usual Information|Patient receive usual informations
15861725|NCT03948711|Device|Near-infrared spectroscopy (NIRS) monitoring of cerebral oxygenation|Monitoring before anesthesia to hospital admission. No treatment decisions made based on monitoring.
15861726|NCT03948698|Other|Innovative approached to pediatric TB care|Includes integration of TB care in non-TB entry points in facilities, decentralization from higher level clinics to lower levels, strengthening screening activities and building diagnosis and treatment capacity among healthcare workers
15861727|NCT03948685|Drug|Carvedilol SR|blood pressure, heart rate based titrated carvedilol SR for 24 weeks
15861728|NCT03948685|Drug|Placebo|Placebo
15861729|NCT03948672|Device|CleanHands System|All participants who regularly access the ICUs will wear the CleanHands system wristband while at work for 5 months and the reminding functionality is turned on.
15861730|NCT03948659|Procedure|Arterio ventricular coupling|We analyse ventriculo arterial coupling (VAC) among cirrhotic patients admitted in intensive care unit, with non-invasive echography method
15861731|NCT03948646|Drug|Sofpironium Bromide, 15%|Active
15861732|NCT03948646|Drug|Vehicle|Vehicle gel
15861733|NCT03948633|Other|Multi-faceted knowledge translation intervention|The intervention consists of education of relevant stakeholders of best practices and integration of best practices into the vaccination delivery program
15861734|NCT03948620|Drug|Macrolides|Macrolide antibiotics, including erythromycin, clarithromycin and azithromycin. Prescriptions of macrolides will be identified using a drug code list based on the British National Formulary (chapter 5.1.5) and the date of the first prescription was used as the index date of exposure.
15861735|NCT03948620|Drug|Penicillins|The comparison group consists of children whose mother were prescribed penicillins during pregnancy. Prescriptions of penicillins will be identified using a drug code list based on the British National Formulary (chapter 5.1.1) and the date of the first prescription will be used as the index date of exposure.
15861736|NCT03948607|Other|Electroencephalography during sustained attention task.|"The Continuous Temporal Expectancy Task (CTET) (O'Connell et al., 2009) is a very demanding discrimination task with sustained attention. It consists of the presentation on a computer screen of a visual pattern resembling a checkerboard that changes orientation at regular intervals of time. In this task the subject must respond (pressing a response button) to the appearance of rare target stimuli that have a longer duration (1120 ms) than non-target stimuli (800 ms).
~SART (Sustained Attention to Response Task) (Robertson et al., 1997) is a task of inhibition (Go / No-Go task) to evaluate the capacities of sustained attention. It consists in the successive and random presentation on a computer screen of the numbers from 1 to 9. In this task the subject must respond, by pressing a response button, to the appearance of all the numbers (very non-target stimuli frequent), with the exception of the number 3."
15861737|NCT03948594|Dietary Supplement|resource|1 packet resource(237ml), 1.05kcal/ml, 53.6g carbohydrate and 9g protein
15861738|NCT03948594|Other|plain water|250ml plain water
15861739|NCT03948581|Drug|Vedolizumab SC|Vedolizumab SC liquid.
15861740|NCT03948568|Combination Product|Endocrine Therapy and Radiotherapy|Endocrine therapy and radiotherapy administered either concurrently or sequentially
15861741|NCT03948555|Diagnostic Test|Magnetic Resonance Imaging (MRI) using ultrasmall super paramagnetic iron oxides (USPIOs)|All patients will undergo two MRI scans (one MRI scan pre-USPIO administration, and one MRI scan 24-36 hours following USPIO administration) and blood samples will be taken for future biomarker analysis.
15861742|NCT03948542|Other|Outcome|"Nerve Recovery
~NCV
~Funcional assessment"
15861810|NCT03948022|Drug|Progesterone 50Mg/mL Oil|100 mg daily intramuscular injections
15861811|NCT03948022|Drug|Crinone 8% Vaginal Gel|180 mg daily vaginal gels
15861744|NCT03948516|Device|HemeChip|The basis of HemeChip technology lies in Hb electrophoresis, in which Hb types C, A2, S, F, and A0 have net negative charges in an alkaline solution. Differences in Hb mobilities allow separation to occur within the sieving medium, cellulose acetate paper. HemeChip technology is a low-cost, point-of-care translation of the electrophoresis method that has been well established, readily accepted by clinicians, and widely applied in SCD diagnosis for well over 40 years. HemeChip offers a $2 screening test for SCD (and other Hb disorders), which takes 10 minutes to run. It is mobile and easy-to-use; it can be performed by anyone after a short (30 minute) training.
15861745|NCT03948503|Procedure|Mulligan concept|Mobilization with movement during an active dorsi-flexion of the ankle
15861746|NCT03948503|Procedure|Placebo|Sham mobilization with movement during an active dorsi-flexion of the ankle
15861747|NCT03948490|Device|ReMind iPad app|Evidence-based program to improve attention and memory through (1) cognitive training and (2) teaching compensatory skills in patients with brain tumors.
15861748|NCT03948490|Device|Healthy SMS texting|Participants receive a daily message sent at a random time (within their chosen timeframe(s); e.g. 9am-9pm). Messages will focus on patient-based education-focused health-related quality of life and cognitive education such as internal and external cognitive compensatory strategy training, fatigue management, and coping skills.
15861749|NCT03948490|Behavioral|In-person cognitive rehabilitation|The in-person cognitive rehabilitation will focus on the application of evidenced based strategies recommended as practice guidelines by the American Congress of Rehabilitation Medicine Cognitive Rehabilitation Task Force (ACRM-CR). The treatment occurs in two stages 1) comprehensive neuropsychological assessment and rehabilitation planning and 2) implementation of treatment planning.
15861750|NCT03948490|Behavioral|Telehealth cognitive rehabilitation|The telehealth cognitive rehabilitation will take place over secure UCSF Zoom. It will focus on the application of evidenced based strategies recommended as practice guidelines by the American Congress of Rehabilitation Medicine Cognitive Rehabilitation Task Force (ACRM-CR). The treatment occurs in two stages 1) comprehensive neuropsychological assessment and rehabilitation planning and 2) implementation of treatment planning
15861751|NCT03948477|Drug|Pantoprazole 40mg|Proton pump inhibitor, drug action is to irreversibly block the hydrogen-potassium adenosine triphosphatase enzyme system (the 'proton pump') of the gastric parietal cell. This reduces basal and stimulated gastric acid secretion therefore raising gastric pH.
15861752|NCT03948477|Drug|Placebo|Matched placebo
15861753|NCT03948464|Drug|Slow release oral morphine (SROM)|Slow release oral morphine is an opioid agonist. Slow release oral morphine will be administered via daily witnessed ingestion at designated community pharmacies.
15861754|NCT03948464|Drug|Methadone|Methadone is an opioid agonist. Methadone will be administered via daily witnessed ingestion at designated community pharmacies.
15861755|NCT03948451|Drug|[14C]AZD5718 Oral Suspension|200 mg dose of [14C]AZD5718 Oral Suspension
15861756|NCT03948438|Procedure|Endoscopic septotomy|Patients will be placed in left lateral decubitus position, either in conscious sedation or under deep sedation with propofol or endotracheal intubation.The procedure will be performed with a flexible standard endoscope and started with initial endoscopic examination with suction of possible retained material insidethe diverticulum. An incision of the bridge between the ZD and the esophagus will be done (using one endoscopic procedure as POES or FESD or other)
15861757|NCT03948425|Radiation|spectral CT|Head spectral CT
15861758|NCT03948412|Device|Closed Incision Negative Pressure Wound Therapy (Prevena)|Closed Incision Negative Pressure Wound Device (Prevena) applied to closed wound at completion of operation.
15861759|NCT03948412|Other|Control - Standard Dressings|Standard wound dressings applied to closed wound at completion of operation.
15861760|NCT03948399|Device|Duplex scanning of carotid arteries|Measurement of carotid arteries
15861761|NCT03948399|Device|ABI measurement|ankle brachial index (ABI) assessment
15861762|NCT03948386|Drug|isobaric bupivacaine|The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.
15861763|NCT03948386|Drug|hyperbaric bupivacaine|TThe anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.
15861764|NCT03948386|Drug|isobaric mepivacaine|The anesthesiologist and CRNA or resident performing the spinal will perform spinal anesthesia according to standard operating procedures with the randomly assigned local anesthetic.
15861765|NCT03948373|Device|CPAP treatment|In this group of patients (CPAP group) will be prescribed CPAP treatment at an optimal pressure. It will be performed a CPAP titration with an automatic or manual CPAP according to usual clinical practice.
15861766|NCT03948360|Device|Low-Irradiance Monochromatic Biostimulation (LIMB) Device|The LIMB System is a portable and wearable phototherapeutic system that consists of a Light Patch and Power Pack. The Power Pack delivers power to the Light Patch, which attaches to the participant and emits blue spectrum (405nm low-irradiance) light. The Light Patch contains an array of thin optical arrays that evenly illuminate the surface. The Power Pack is powered by a Lithium Thionyl Chloride (Li-SOCI2) battery.
15861767|NCT03948360|Other|Standard of Care|Standard of care therapy as defined for this clinical trial is standard gauze dressing soaked in Sulfamylon (mafenide acetate) solution.
15861768|NCT03948347|Drug|Liraglutide|The treatment arm will receive the starting dose of liraglutide of 0.6 mg/d subcutaneously once daily, and the dose will be increased to 1.8 mg/d in two weeks, and then continue to administrate this dose for 90 days.
15861769|NCT03948334|Drug|ZPL389 30mg|30mg of ZPL389; once daily
15861770|NCT03948334|Drug|ZPL389 50mg|50mg of ZPL389; once daily
15861771|NCT03948334|Drug|TCS and/or TCI|Topical corticosteroids (TCS) and /or topical calcineurin inhibitors (TCI) were used concomitantly or intermittently based on disease severity.
15861772|NCT03948321|Procedure|Aminolevulinic acid photodynamic therapy|Aminolevulinic acid photodynamic therapy
15861773|NCT03948308|Biological|blood sample|blood sample before, during and after infection treatment
15861812|NCT03947996|Other|Stretching exercise|Stretching (30 minutes, 5 days per week, 8 weeks)
15861813|NCT03947996|Other|Walking exercise|Walking (30 minutes, 5 days per week, 8 weeks)
15861872|NCT03947424|Device|LP Er:YAG|LP Er:YAG applied to oral mucosa
15861873|NCT03947424|Device|SMOOTH mode Er:YAG|SMOOTH mode Er:YAG applied to oral mucosa
15861774|NCT03948295|Dietary Supplement|Lipid Challenge|After fasting for 10 hours, all participants will undergo a lipid challenge with Calogen. Calogen is a commercially available liquid high-energy long chain triglyceride fat emulsion used to fortify foods. Calogen provides 50 grams of long chain triglycerides per 100 mL. Participants must avoid physical activity during the 6 hour study period to avoid changes in metabolism that could affect the results of the study.
15861775|NCT03948269|Behavioral|group behavioral cognitive therapy|First, we will establish a WeChat group containing the imGT group members and psychiatrists, in which everyone can talk instantly. The interactive treatments will be conducted every Friday evening for a duration of 1.5 hours via text, audio or video messaging. Table 1 summarizes the module topics and provides detailed information on the treatment program. All modules will be saved for repeated viewing after completion. Second, we will establish another WeChat program named Punched-in which participants report on aspects of their everyday life such as diet, sports, readings or mood, according to the plan made by psychiatrists, via text, audio, photo or video message. This program will only be visible to and able to be commented on by participants and psychiatrists.
15861776|NCT03948256|Procedure|Control intervention|Prompt closure of EVD with subsequent observation period
15861777|NCT03948256|Procedure|Experimental intervention|Gradual weaning of EVD with 5 cmH2O increase in drainage resistance daily until complete closure with subsequent observation period
15861778|NCT03948243|Dietary Supplement|Licorice|Experimental :G.Glabra Licorice extract: 2 gelatin capsules (75 mg) per day for 14 days
15861779|NCT03948243|Drug|Alprazolam 2 MG|substrate
15861780|NCT03948243|Drug|Caffeine 100 MG|substrate
15861781|NCT03948243|Drug|Tolbutamide 250 mg|substrate
15861782|NCT03948243|Drug|Dextromethorphan 30mg|substrate
15861783|NCT03948230|Biological|Salt with / without water|Drinks with and without a salt containing capsule
15861784|NCT03948217|Other|Circadian Lighting regimen|Circadian lighting regimen with one major fluctuation, high light intensity and color
15861785|NCT03948191|Drug|Methylprednisolone|500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. once a week for 6 weeks.
15861786|NCT03948191|Drug|99Tc-MDP(99Technetium-Methylenediphosphonate Injection)|15mg i.v. infusion once a day for 10 days, 20 days apart, received 3 courses of infusions.
15861787|NCT03948178|Drug|Levosimendan|Levosimendan 1 mg capsule for oral administration
15861788|NCT03948165|Procedure|Distal Transradial Access|The distal radial artery needs to be punctured with specialized equipment with a 20, 21 or 22-gauge puncture needle, using a transfixion or anterior wall technique. A 0.025 in, 46 cm guide was introduced in the system, followed by the introduction of the 5 Fr, 6 Fr, 7Fr hydrophilic arterial sheath or 5 Fr, 6 Fr or 7 Fr Glidesheath Slender introducer (TerumoIS, Tokyo, Japan), after a small incision in the skin.
15861789|NCT03948152|Other|Standard of Care|Participants will have a Positive Airway Pressure (PAP) mask chosen to wear for a period of 90 days as provided by the sites standard of care.
15861790|NCT03948152|Other|Mask Advice Tool|Participants will have a Positive Airway Pressure (PAP) mask chosen to wear for a period of 90 days as provided by the mask advice tool.
15861791|NCT03948139|Device|Functional Brace|The study will generate five standardized sized braces based on measurements from prior scans that will be stocked at each institution and modified by the local orthotist to fit the needs of each patient. This will facilitate expedited care while obtaining the same clinical and radiographic results as the fully customized braces. This idea has the potential to be extrapolated to the wider clinical community, creating a true shift in pediatric orthopaedic clinical practice throughout the country.
15861792|NCT03948139|Device|Hip Spica Cast|Traditional spica casts, the current standard of care for diaphyseal femoral shaft fractures with minimal shortening in children age 0-5 years old. Although spica cast immobilization is standard of care for femur fractures in young children, caring for a child in a spica cast presents a significant socioeconomic burden on families and the healthcare system. Basic hygiene and transportation for a child in a spica cast requires burdensome adjustments for caretakers, as well as the added expenses of specialized car seats or transportation services. Improper spica cast care can lead to skin complications, additional visits for cast adjustments, or even revision casting in the operating room.
15861793|NCT03948126|Other|Questionnaire about geophagia (knowledge about soil/clay consumption and knowledge of the health effects of geophagy)|
15861794|NCT03948113|Other|Dialysis|
15861795|NCT03948100|Other|Educational Intervention|Undergo dyadic education program
15861796|NCT03948100|Other|Quality-of-Life Assessment|Ancillary studies
15861797|NCT03948100|Other|Questionnaire Administration|Ancillary studies
15861798|NCT03948100|Procedure|Yoga|Undergo dyadic yoga
15861799|NCT03948087|Device|Vacuum Removable Rigid Dressing (VRRD)|Intra-operative application of device.
15861800|NCT03948074|Drug|Cannabis|Medicinal Cannabis Oil
15861801|NCT03948061|Other|Cherry juice|FruitSmart® Cherry Concentrate: Dark Sweet Cherry Juice Concentrate produced from dark sweet cherries to retain the characteristic color and flavor of the whole fruit.
15861802|NCT03948061|Other|Placebo beverage|Cherry flavored placebo beverage prepared from commercially available cherry syrup with food coloring and thickener to match the color and viscosity of the cherry concentrate.
15861803|NCT03948048|Device|ECMO|ECMO is used to intervene septic shock and refractory septic shock
15861804|NCT03948035|Drug|Elotuzumab|i.v. infusion. Induction 6 cycles: 10mg/kg BW D1,8,15,22 of cycle 1 and 2, D1,15 of cycles 3-6. Consolidation 4 cycles: 10mg/kg BW D1,15 of cycle 1-4. Maintenance 28-day cycles: 20mg/kg BW D1 of each 28-day cycle.
15861805|NCT03948035|Drug|Carfilzomib|i.v. infusion. Induction 6 cycles: 20 mg/m² on D1 and 2 of cycle 1, 36 mg/m² on D8, 9, 15, 16 of cycle 1, 36 mg/m² on D1,2,8,9,15,16 of cycle 2-6; Consolidation 4 cycles: 36 mg/m² on days 1, 2, 8, 9, 15, 16 of cycles 1-4.
15861806|NCT03948035|Drug|Lenalidomide|hard capsule for oral use. Induction 6 cycles: 25mg D1-21 of cycle 1-6. Consolidation 4 cycles: 15mg D1-21 of cycle 1, 25mg D1-21 ov cycle 2-4. Maintenance 28-day cycles: 10mg D1-28 of cycle 1,2,3, 15mg D1-28 of cycle 4 and all subsequent cycles.
15861807|NCT03948035|Drug|Dexamethasone|orally and i.v. IN ARM A:Induction 6 cycles: 28mg p.o. and 8mg i.v. D1,8,15,22 of cycles 1-2 and D1,15 of cycles 3-6, 40mg p.o. D8,22 of cycle 3-6. Consolidation 4 cycles: 28mg p.o. and 8mg i.v. D1,15 of cycle 1-4 and 20mg p.o. D8,22 of cycle 1-4. IN ARM B: Induction 6 cycles: 40mg p.o. D1,8,15,22 of cycles 1-6. Consolidation 4 cycles: 20mg p.o. D1,8,15, 22 of cycle 1-4 .
15878653|NCT03815240|Other|ALLEVYN Life Sacrum|adhesive sacrum dressing
15861814|NCT03947983|Behavioral|Sensor-controlled digital game (SCDG)|"The SCDG will involve a narrative, the goal of which is to help an avatar in the game avoid rehospitalization by using game points, earned via the participant's real-time behaviors, in game tasks that help maintain the avatar's optimal HF health status. Real-time behaviors of weight-monitoring and physical activity will be tracked by an off-the-shelf sensors and app (Withings). The data from the Withings sensors will then be routed to our SCDG app.
~The digital game paired with sensors will enable objective tracking of real-time behaviors such as physical activity, and weight monitoring, and provide personalized, contextually relevant feedback (e.g., reduce fluid intake or call doctor for weight gain) to motivate engagement in and generate habit formation of heart failure related self-management behaviors."
15861815|NCT03947983|Behavioral|Sensor Only|Real-time behaviors of weight-monitoring and physical activity will be tracked by an off-the-shelf sensors and app (Withings). This group will also be provided with standardized evidence-based HF educational material.However, the data from the Withings sensors will not be routed to the SCDG.
15861816|NCT03947970|Drug|[14C] CR845|Subjects will receive a single dose of 230 mcg CR845 solution containing 100 microcuries [14C] CR845, administered via IV bolus (the total dose of CR845 will range from 1.7 to 3.1 mcg/kg)
15861817|NCT03947957|Diagnostic Test|collection of expectoration, stools and blood|collection of expectoration, stools and blood
15861818|NCT03947944|Procedure|SMILE using manifest refraction planning|The treatments of astigmatism were planned using either the manifest refraction (manifest refraction group) or the vector planning method (vector planning group). The surgery was performed with standardized techniques with triple centration technique using the 500-KHz VisuMax system (Carl Zeiss Meditec AG, Jena, Germany). The superior cap depth was set as 120 µm, and the length of the side cut was set to 2 mm. Once the anterior (upper) and posterior (lower) planes of the lenticule were defined, the anterior and posterior interfaces were dissected using a microspatula with a blunt circular tip and extracted with microforceps. The integrity of the lenticule was assessed subsequently. The treatment plan for the vector planning group involved a combination of refractive astigmatism with 60 % emphasis and corneal astigmatism with 40 % emphasis.
15861819|NCT03947944|Procedure|SMILE using vector planning|The treatments of astigmatism were planned using either the manifest refraction (manifest refraction group) or the vector planning method (vector planning group). The surgery was performed with standardized techniques with triple centration technique using the 500-KHz VisuMax system (Carl Zeiss Meditec AG, Jena, Germany). The superior cap depth was set as 120 µm, and the length of the side cut was set to 2 mm. Once the anterior (upper) and posterior (lower) planes of the lenticule were defined, the anterior and posterior interfaces were dissected using a microspatula with a blunt circular tip and extracted with microforceps. The integrity of the lenticule was assessed subsequently. The treatment plan for the vector planning group involved a combination of refractive astigmatism with 60 % emphasis and corneal astigmatism with 40 % emphasis.
15861822|NCT03947905|Procedure|Virtual visit|Type of visit
15861823|NCT03947892|Diagnostic Test|PET-CT|A PET-CT scan will be performed systematically for all patients included with the SUVmax, SUV peak, MTV of the lesion, and up to 3 suspicious ganglia during the visual analysis.
15861824|NCT03947879|Drug|L-glutamine|15 g of L-glutamine twice daily by mouth for 3 months.
15861825|NCT03947879|Other|No L-glutamine|The same patients will be given no L-glutamine for 3 months.
15861826|NCT03947840|Behavioral|Physical activity|Se their physical activity level
15861827|NCT03947827|Drug|Minocycline|Participants will be randomized to receive either Minocycline or placebo added to standard oral antidepressants.
15861828|NCT03947814|Drug|Pimodivir|Participants will receive single oral dose of 600 mg pimodivir as 2*300 mg tablets.
15861829|NCT03947801|Other|Greek Yogurt|Female competitive soccer players (11-16y) will consume 0% plain Greek yogurt immediately following the training session, 1 h prior to bedtime, as well as one serving between breakfast and lunch on the subsequent day.
15861830|NCT03947801|Other|Isoenergetic carbohydrate|Female competitive soccer players (11-16y) will consume an isoenergetic carbohydrate supplement immediately following the training session, 1 h prior to bedtime, as well as one serving between breakfast and lunch on the subsequent day.
15861831|NCT03947788|Behavioral|OKQ Training Program|The OKQ training program helps clinicians more efficiently meet the needs of women's pregnancy intentions and provide evidence-based care.
15861832|NCT03947775|Drug|9-valent HPV vaccination|Gardasil-9 is a novel, 9-valent HPV recombinant vaccine, which expands the coverage of oncogenic HPV types, with the addition of HPV types 31, 33, 45, 52, and 58 to the existing quadrivalent vaccine types. The addition of these five oncogenic types is estimated to improve cancer coverage to 90% (versus 70% for the quadrivalent vaccine) [38]. With its expanded coverage of oncogenic HPV types, its proven efficacy in primary prevention and its potential role in mitigating HGAIN recurrences.
15861833|NCT03947736|Diagnostic Test|cfDNA was detected by dPCR|Without drug intervention, the patient's peripheral blood was collected and cfDNA was extracted for digital PCR detection.
15861834|NCT03947723|Device|Radiofrequency ablation|The eyelid segments to be excised as part of their planned lateral tarsal strip procedure will be marked and divided into 4 equal sections (2 sections on each lid). A corneal shield will be placed into the fornix prior to treatment. Each section will be treated with the designated power setting in the following manner. The probe will be inserted into the follicle under direct visualization to a depth of approximately 1.4 mm. The designated power will be applied for 1 second. All lashes in each segment will be treated. The segments will then be excised and placed into labelled and coded containers of formalin.
15861835|NCT03947710|Other|High-protein meals|Patients on maintenance hemodialysis will consume high protein meals during dialysis for one week (3 dialysis sessions)
15861836|NCT03947710|Other|Low- protein meals|Patients on maintenance hemodialysis will consume low protein meals during dialysis for one week (3 dialysis sessions)
15861837|NCT03947710|Other|No meals|Patients on maintenance hemodialysis will not consume meals during dialysis for one week (3 dialysis sessions)
15861874|NCT03947424|Device|sham|Er:YAG laser applied to oral mucosa with no energy
15861841|NCT03947684|Device|Transcranial Magnetic Stimulation Device|The TMS device electrically stimulates the intended parts of the brain. In this study, the investigator plan to target the part of the brain cortex that is responsible for the voluntary motion of the leg muscles, whose functions are under investigation.
15861842|NCT03947671|Device|Rapr Rounds Hyper/Hypothermia Wraps|Rapr Round® vest and leg wraps will placed around the torso and legs of the participant and will be adjusted to maintain normal body temperature
15861843|NCT03947671|Drug|Acetaminophen|Acetaminophen will be administered as it would be per standard of care
15861844|NCT03947658|Procedure|Surgical crown lengthening|Surgical lengthening of teeth with short clinical crown and prosthetic rehabilitation
15861845|NCT03947645|Device|Ipsilesional stimulation|Device: ipsilesional transcranial stimulation, neuromuscular Stimulation over target muscle
15861846|NCT03947645|Device|Contralesional stimulation|Device: contralesional transcranial stimulation, neuromuscular stimulation over target muscle
15861847|NCT03947632|Diagnostic Test|serum ferritin and hemoglobin test|Five milliliter of blood samples were collected in two tubes (ethylenediaminetetraacetic acid and gel) at Fatimid foundation by a trained phlebotomist prior to blood transfusion to determine hemoglobin and serum ferritin.
15861849|NCT03947606|Behavioral|CASCADE (CAre Supporters Coached to be Adept DEcision partners)|CASCADE (CAre Supporters Coached to be Adept DEcision partners) is a multicomponent, nurse coach-led supportive care intervention designed to increase family caregivers' skills in providing decision support to individuals with advanced cancer. In a series of weekly, one-on-one, 15-20 minute, in-person or telephone sessions, family caregivers receive psychoeducation on principles of providing effective social support and decision partnering, decision support communication, and Ottawa Decision Guide training.
15861850|NCT03947593|Other|No Intervention|No intervention is being administered.
15861851|NCT03947580|Other|Use of the Dvectis Single pad|"Change in pain intensity - range of VAS (mm) between Visit 1 and Visit 2 Dvectis Single pads compared to without using a pad."
15861852|NCT03947580|Other|Use of the Dvectis Double pad|"Change in pain intensity - range of VAS (mm) between Visit 1 and Visit 2 Dvectis Double pad compared to without using a pad,
~Categorisation of adverse events,
~Categorisation of deficiencies of a medical device in patients enrolled in treatment groups using Dvectis Single and Dvectis Double pad,
~Number of patients with adverse events,
~Number of patients with deficiencies of medical device enrolled in treatment groups using Dvectis Single and Dvectis Double"
15861853|NCT03947580|Other|Use of no pad|Description is not needed
15861854|NCT03947567|Drug|Recombinant Human Coagulation FVIII|Participants received SCT800 for prophylaxis and/or on-demand treatment for 120 weeks.
15861855|NCT03947554|Dietary Supplement|HRG80 Panax ginseng|Panax ginseng containing 63.4 mg ginsenosides
15861856|NCT03947554|Dietary Supplement|Panax ginseng|Panax ginseng containing 19.6 mg ginsenosides
15861857|NCT03947554|Dietary Supplement|Placebo|800 mg excipient
15861860|NCT03947528|Drug|Sarpogrelate HCL 300mg|a single oral dose administration in healthy volunteers under fed condition
15861861|NCT03947515|Procedure|prostate biopsy|All patients included, will report to the urology department on the date previously agreed with the surgeon. The patient will be seen by the nurse and urologist on duty as part of outpatient care or, more rarely, in ambulatory care. After verification of the patient's identity, the signature of informed consent, the absence of immediate contraindications to biopsy (haemorrhagic and infectious) and the patient's proper preparation (antibiotic prophylaxis and possible enema), the patient will be installed for the taking of samples covered by the protocol (rectal swabbing and prostate biopsies, see paragraph IX). If the patient has not taken the antibiotic prophylaxis or performed the enema, he or she will be reconvened at a later date for the biopsies. After the prostatic biopsies have been performed, the patient's participation in the study ends and his follow-up resumes according to the recommendations adapted to his pathology.
15861862|NCT03947515|Other|Urinary sampling|It will be collected after the prostate massage performed by the surgeon in charge of the patient during his clinical examination for prostate cancer screening. After elimination of the first draft, the urine will be collected in 2 tubes with borated preservative
15861863|NCT03947515|Other|Rectal swabbing before biopsies are performed|A rectal swab will then be taken by the urologist on the day the prostate biopsies are taken. The analysis of the digestive microbiota will eliminate contamination of prostate biopsies by bacteria from the faecal flora during transrectal sampling
15861864|NCT03947502|Behavioral|Educational intervention in neurobiology of pain|The educational intervention will intend to make the individual aware that in the processes of learning, sensitization, habituation and acquisition of beliefs about pain there are automatic unconscious mechanisms, which can be modulated through conscious behaviors. Based on this the investigators propose the active participation of patients in the process of desensitization of their central nervous system. The investigators will try to encourage attention and weaken the neuronal connections that make up the pain neuromatrix to establish new connections thanks to neuroplasticity.
15861865|NCT03947489|Drug|Sarpogrelate HCL 300mg|a single oral dose administration in healthy volunteers under fasting condition
15861866|NCT03947476|Device|thoracic band|Thoracic band fixation
15861867|NCT03947463|Procedure|PECS block|After the induction of general anesthesia, PECS block was administered patients via ultrasound guided technique. We used Mindray M7 Portable ultrasound system using linear probe with (5-10 MHz) frequency. After cleaning the infra clavicular and axillary region with 2% chlorhexidine in 70% Alcohol solution, ultrasound probe was placed in the infraclavicular region and pectoral major and minor were identified. After identification of the landmarks, 20 gauge 50mm Visoplex needle was inserted in-plane direction. 20ml of 0.25% bupivacaine (within the safe limit of its dose) was infiltrated between pectoralis major and pectoralis minor muscle and the spread was visualized on the ultrasound screen.
15861868|NCT03947450|Biological|Autologous Skin Fibroblasts|The site or whole stump will be injected with autologous fibroblasts
15861875|NCT03947411|Drug|Oseltamivir Phosphate|Take the dosage of Oseltamivir Phosphate recommended according to the instructions.support treatment such as antiasthmatic, expectorant and antipyretic use only in need.
15861876|NCT03947411|Drug|Xiyanping injection+Oseltamivir Phosphate|Take the dosage of Oseltamivir Phosphate recommended according to the instructions.Xiyanping injection intravenous administration of 0.4mL/kg/day ,QD for 7-10 days.support treatment such as antiasthmatic, expectorant and antipyretic use only in need.
15861877|NCT03947398|Device|BLIMP balloon|Using BLIMP balloon to cross lesion
15861878|NCT03947398|Device|Low profile balloon|using low profile balloon to cross lesion
15861879|NCT03947385|Drug|IDE196|IDE196 dosed orally, twice daily for each 28-day cycle
15861880|NCT03947385|Drug|Binimetinib|Binimetinib dosed orally, twice daily for each 28-day cycle
15861881|NCT03947385|Drug|Crizotinib|Crizotinib dosed orally, twice daily for each 28-day cycle
15861882|NCT03947372|Procedure|Appendectomy|removal of acutely inflamed appendix
15861883|NCT03947359|Diagnostic Test|Fibroscan Touch 502 M probe|Measurement of liver stiffness
15861884|NCT03947359|Diagnostic Test|Fibroscan Touch 502 S probe|Measurement of liver stiffness
15861885|NCT03947346|Other|Urine sample|The urine collected from the first morning void will be used to assess urine creatinine and microalbumin. The fresh urine specimen will be analyzed for novel urinary biomarkers of (urinary NGAL, TGF-β1, IL-18 and KIM-1). Serum BUN, creatinine, and cystatin-C will be assessed using serum samples drawn for routine clinical care.
15861886|NCT03947333|Other|My Diabetes Care|The My Diabetes Care is embedded within an existing patient web portal (My Health at Vanderbilt) and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy-level sensitive educational resources, and contains secure-messaging capability.
15861887|NCT03947320|Drug|Recombinant Human Coagulation FVIII|Participant received SCT800 for prophylaxis with 25 - 50 IU/kg injection once every other day or three times per week for 6 months.
15861888|NCT03947307|Device|lymphtaping using Easytape®|lymphtaping using Easytape® on day 1 after surgery by specifically trained physiotherapists. If possible the taping will be left for 7 days.
15861889|NCT03947307|Procedure|compression treatment|manual lymphatic drainage followed by compression treatment using compressive stockings or compressive bandaging
15861890|NCT03947307|Device|sham taping|sham taping with Leukotape® Classic, a non-elastic tape, that in all other respects resembles Easytape®.
15861891|NCT03947294|Device|Q-NRG®|Energy expenditure measurements
15861892|NCT03947281|Other|Almond snack|The almond intervention will be roasted, unsalted almonds provided at 56 g/day for 28 days. Almonds provide approximately 350 kcals/day.
15861893|NCT03947281|Other|Cereal-based snack|The cereal-based intervention will be a prepared mix of cereal, pretzels, and bread sticks prepared at the WHNRC. It will be provided at the level of 350 kcals per day for 28 days.
15861894|NCT03947268|Radiation|Short course radiotherapy|An accelerated hypo-fractionation 2D-radiotherapy is delivered for palliation in patients with advanced pelvic cancer.
15861895|NCT03947255|Drug|brentuximab vedotin|1.8 mg/kg given intravenously (IV)
15861896|NCT03947242|Drug|Pyrotinib and Trastuzumab plus Vinorelbine|Pyrotinib:400mg orally daily Trastuzumab:8mg/kg ivgtt load followed by 6mg/kg ivgtt 3-weekly for a total of 4 cycles Vinorelbine :25mg/m2 ivgtt 3-weekly for a total of 4 cycles,d1 d8
15861897|NCT03947229|Drug|Clopidogrel mono-therapy|Patients will receive clopidogrel (75 mg once daily) monotherapy without co-administration of aspirin for 24 months after randomization.
15861898|NCT03947229|Drug|Dual-antiplatelet therapy|Patients will receive co-administration of aspirin (100 mg/day) and clopidogrel (75 mg/day) for 24 months after randomization.
15861899|NCT03947216|Drug|Active drug: pimavanserin 17mg (2 strength tablets)|Pimavanserin 17mg (2 strength tablets) will be taken orally daily from day 1 to Visit 4 (Week 8)
15861900|NCT03947216|Drug|Placebo: 2 tablets containing same excipients except active compound|Placebo (2 strength tablets) will be taken orally daily from day 1 to Visit 4 (Week 8)
15861901|NCT03947216|Behavioral|Assessment of severity of ICD (impulse control disorders)|Questionnaire for impulsive-compulsive disorders in Parkinson's disease rating scale (QUIP-RS) will be administrated at day 0, day 28 (Week 4) and day 56 (Week 8)
15861902|NCT03947216|Behavioral|Assessment of motor and non-motors symptoms of PD Evaluation of hyper- and hypodopaminergic behaviors|Hyper- and hypodopaminergic behaviors (Ardouin's scale); Movement disorders society sponsored unified Parkinson's disease rating scale (MDS-UPDR), and daytime and night time sleep by scale for outcomes in Parkinson's disease SLEEP (SCOPA-SLEEP) will be administrated at day 0, day 28 (Week 4) and day 56 (Week 8)
15861903|NCT03947216|Behavioral|Assessment of quality of life|Parkinson's Disease questionnaire (PDQ-39) will be administrated at day 0, day 28 (Week 4) and day 56 (Week 8)
15861904|NCT03947216|Behavioral|Assessment of depression|Montgomery-Åsberg Depression Rating Scale (MADRS) will be administrated at day 0 and day 56 (week 8)
15861905|NCT03947216|Behavioral|Assessment of cognition|Cognitive state of patients by Montreal Cognitive Assessment (MOCA) will be assessed at day 0.
15861906|NCT03947216|Behavioral|Assessment of severity of Parkinson Disease|Clinical Global Impression Severity scale (CGIS) will be administrated at day 0 , day 7, day 14, day 28, day 42 and day 56 (week 8) and day 112 (Week 16)
15861907|NCT03947216|Procedure|Blood analysis|Blood sample will be collected for analyse of safety (blood count/liver and kidney functions, electrolytes) at day 0 and day 56
15861908|NCT03947216|Procedure|Cardiac monitoring|Electrocardiogram will be realized at day 0, 28 and 56.
15861909|NCT03947203|Behavioral|Social media|Provided pamphlet and a private Facebook group where informational messages and content relating to oral health will be shared
15861910|NCT03947190|Biological|R21/Matrix-M|R21: Protein particle malaria vaccine candidate in Matrix-M: Saponin based vaccine adjuvant.
15861911|NCT03947190|Biological|ChAd63/MVA ME-TRAP|ChAd63, chimpanzee adenovirus serotype 63; ME-TRAP, multiple epitope string fused to the thrombospondin-related adhesion protein; MVA, modified vaccinia Ankara.
15861912|NCT03947190|Biological|intradermal injection (ID) or direct venous injection (DVI) of PfSPZ Challenge|PfSPZ Challenge: cryopreserved Plasmodium falciparum sporozoites.
15861938|NCT03946956|Behavioral|Pictured invitation|Participants are receiving an illustrated invitation CVD screening or a classical text-invitation to book an appointment for CVD Screening
15861913|NCT03947177|Behavioral|GMIT|Six 30-minute sessions delivered virtually in a group format. Each week a group facilitator will elicit adolescents' feedback on important topics related to substance use and provide experiential activities to help adolescents explore their beliefs and practice making healthy choices.
15861914|NCT03947177|Behavioral|GMIT+|Six 30-minute sessions delivered virtually in a group format. Each week a group facilitator will elicit adolescents' feedback on important topics related to substance use and provide experiential activities to help adolescents explore their beliefs and practice making healthy choices. Parents and/or guardians will virtually participate in parent-only support group sessions.
15861915|NCT03947164|Other|biopsy|"For cases and controls, before the intervention : a questioning, clinical symptoms of POPs and urinary incontinence, a detailed clinical examination, and an urodynamic assessment (in case of POPs) and an ultrasound guided MEA biopsy.
~Patients will be seen on post-operative visits between 15 days and 2 months after surgery for an examination and clinical examination."
15861916|NCT03947151|Drug|Degarelix injection(s)|1 or 2 degarelix injection(s)
15861917|NCT03947138|Biological|GC3107|BCG Vaccine
15861918|NCT03947138|Biological|Intradermal BCG SSI inj.|BCG Vaccine
15861919|NCT03947125|Drug|Buprenorphine transdermal patch on knee joint|Conventionally buprenorphine transdermal patch had been applied to anterior chest wall or upper arm. But author had applied buprenorphine transdermal patch to painful knee joint in knee osteoarthritic patients. This research is about the effect, adverse effects, and compliance of comparison conventional chest applied buprenorphine transdermal patch group with painful knee joint applied group in knee osteoarthritic patients.
15861920|NCT03947112|Behavioral|Physical activity registration|At start, participants and parents fills out a Self-report questionnaire and the UngKan-3 Questionnaire, before a seven day physical activity registration takes place by use og ActiGraph. A physical activity diary are filled out every evening while the physical activity registration takes places.
15861921|NCT03947099|Drug|Ketamine Hydrochloride|Participants are treated with six one-hour infusions of ketamine hydrochloride over a three week period in hopes of treating symptoms of PTSD.
15861922|NCT03947086|Device|Transcranial Direct Current Stimulation (TDCS)- Active|A constant current stimulator (TCT Research Limited) will be used using electrodes of 5 × 5 cm2 embedded in saline (0.9 % NaCl) and application of 1.5 mA current for 20 minutes for 5 consecutive days. The cathode will be positioned in the right supra-orbital region, and while the anode will have the following provision in the left dorsolateral prefrontal cortex (F3).
15861923|NCT03947086|Device|Transcranial Direct Current Stimulation (TDCS)- Sham|The protocol for participants receiving simulated current is identical, but the device ceases to emit current after 30 seconds of initiation of pacing.
15861924|NCT03947086|Behavioral|Cognitive Training|"Considering that the effects of TDCS are potentiated when applied during the execution of a task (online) (Miniussi, & Ruzzoli, 2013), in the present study all participants received cognitive training, performed concomitantly with neurostimulation.
~Cognitive training consists of two parts: standardized tasks directed to social cognition and activities that stimulate executive functions. The first part consists of tasks contained in a battery of social games (Gao & Maurer, 2009; Dillon, Kannan, Dean, Spelke, & Duflo, 2017). While the tasks directed to the executive domain are, namely: running mazes, assembling figures, completing parts of figures and the Super Lynx Memory Game. All participants, regardless of whether they underwent active or simulated stimulation, received cognitive training, respecting the ethical principles of ensuring therapeutic assistance to those involved."
15861925|NCT03947073|Other|Education|Three cartoon illustrated educational videos with information on gestational diabetes will be provided to the patient in addition to standard of care.
15861926|NCT03947047|Diagnostic Test|NA-NOSE|Breath and blood samples for distinguishing biomarkers.
15861927|NCT03947034|Drug|Drugs inducing hyperammonemia|Drugs susceptible to induce metabolic toxicities such as hyperammonemia
15861928|NCT03947021|Radiation|Computed tomography (CT) scan|A CT scan of thorax and heart will be performed in the CT+BSPM group.
15861929|NCT03947021|Device|Body-surface potential mapping|Measurement of 256-lead body-surface electrocardiogram
15861930|NCT03947008|Other|Intuitive Eating Program|"A 5-week Intuitive Eating Curriculum created by a Registered Dietitian, Kaylee Frazier, will be used. The creator of this curriculum was contacted for permission and the curriculum was modified for use with college women.
~The goal of the program is to challenge and eventually shift participant's mindset from the traditional diet culture towards a way of eating that is driven by their unique bodily needs. Content will focus on training participant to listen to their internal body cues for hunger opposed to restricting or eliminating foods. A list of intuitive eating principles and ways to incorporate them into daily routines will be provided to the participants throughout the sessions, coupled with homework assignments, journaling, and exercises to be completed before subsequent sessions."
15861931|NCT03946995|Other|Dry Needling Group|"Hot Pack will be applied on upper trapezius muscles before session for general relaxation for 7-10 minutes. Generalized Stretching and strengthening neck exercises will be performed. Then after wearing gloves and appropriate personal protective measures, a thin filiform needle will be inserted which will penetrate into the skin and stimulate underlying myofascial trigger points.
~The treatment will be continued for 2 weeks with 2 sessions per week."
15861932|NCT03946995|Other|Graston Technique Group|"Hot Pack will be applied on upper trapezius muscles before session for general relaxation for 7-10 minutes. Generalized Stretching and strengthening neck exercises will be performed.
~Later, lubricant will be applied to the skin, and Graston technique will be applied using instrument over the active myofascial trigger points in upper trapezius.
~The treatment will be continued for 2 weeks with 2 sessions per week."
15861933|NCT03946982|Procedure|low thoracic epidural|obstetric epidural catheters inserted at low thoracic intervertebral spaces
15861934|NCT03946982|Procedure|lumbar epidural|obstetric epidural catheters inserted at low thoracic intervertebral spaces (conventional)
15861935|NCT03946969|Drug|Sintilimab|Sintilimab 200mg ivd d1, repeated every 3 weeks for two cycles.
15861936|NCT03946969|Drug|Liposomal Paclitaxel + Cisplatin + S-1|Liposomal Paclitaxel 135mg/m2 ivd d1 + Cisplatin 25mg/m2 ivd d1-3 + S-1 40mg capsule po d1-14, repeated every 3 weeks for two cycles.
15861937|NCT03946956|Behavioral|Prebooking|Participants are receiving a prebooked appointment for CVD screening or being invited to book an appointment for CVD Screening
15862018|NCT03946202|Drug|Hydrogen Peroxide|Hydrogen Peroxide
15878654|NCT03815240|Other|Optifoam® Gentle Sacrum|adhesive sacrum dressing
15861939|NCT03946943|Drug|Anlotinib|Once a day dosing of anlotinib alone for the first 7 days, Anlotinib ( 12mg, QD, PO, d1-14, 21 days per cycle), take once when limosis in the morning. If patients cannot suffer from AEs, they can get declined dosage.
15861940|NCT03946943|Drug|Toripalimab|Toripalimab 240mg shall be administered via intravenous (IV) infusion, once every 21 days, on day 8 and day 29 of the first cycle, and days 1 and 22 of the following cycles.
15861941|NCT03946943|Procedure|Blood Draw|Peripheral blood draws for correlative studies characterizing T-cells in peripheral blood will be performed at three timepoints: 1) pre-treatment, 2) on-treatment on cycle 3 day 1, and 3) off-study.
15861942|NCT03946943|Procedure|Tumor Specimen Collection|Tumor specimen collection via core needle biopsy for correlative studies characterizing T-cells in tumor tissue will occur at three timepoints: 1) pre-treatment, 2) on-treatment on cycle 3 day 1, and 3) off-study.
15861943|NCT03946917|Drug|JS001|JS001 3 mg/kg, iv drip, d1, d15, q4w
15861944|NCT03946917|Drug|regorafenib tablet|80/120/160 mg, po, d1-d21, Q4w.
15861945|NCT03946904|Device|Er,Cr:YSGG Laser|Patients with towo similar size lesions of either Class I or class v cavities selected as subjects. in the same appointment, both cavities are prepared by the Er'Cr:YSGG. one lesion was prepared with high power laser setting first to ablate the enamel, dentin, and caries. the other lesion was prepared with low power setting to start and is aimed at applying low level laser therapy (LLLT) first before using high power.
15861946|NCT03946891|Drug|Inhaled Furosemide|Subjects in the A arm will receive 1 mg/kg of inhaled furosemide Q 24 hours for 3 days. This will be followed by a washout period of a day followed by 1 mg/kg of intravenous furosemide Q 24 hours for 3 days.
15861947|NCT03946891|Drug|Intravenous Furosemide|Subjects in the B arm will receive 1 mg/kg of intravenous furosemide Q 24 hours for 3 days followed by a washout period, which is then followed by 1 mg/kg of inhaled furosemide Q 24 hours for 3 days.
15861948|NCT03946878|Drug|Acalabrutinib|Given PO
15861949|NCT03946878|Drug|Venetoclax|Given PO
15861950|NCT03946865|Other|Reiki Therapy|Reiki is a healing practice that originated in Japan. Reiki practitioners place their hands lightly on or just above the person receiving treatment, with the goal of facilitating the person's own healing response.
15861951|NCT03946852|Device|Abdominal Regional Perfusion|Abdominal Regional Perfusion
15861952|NCT03946826|Drug|Halometasone Cream|Halometasone is a potent halogen - containing topical glucocorticoid. Have stronger fight inflammation, fight allergy, contractive hemal, reduce hemal to connect the action of permeability and fight hyperplasia
15861953|NCT03946826|Drug|Vaseline|Vaseline belongs to a kind of mineral wax, without irritant, not easy to deteriorate, can let skin surface form a protective film when used on the skin, let the moisture of the skin be evaporated not easily, have better protect wet effect
15861954|NCT03946826|Radiation|Pulsed dye laser (PDL)|Pulsed dye laser (PDL) is effective for vasodilatory diseases, especially for the superficial to middle layers of the dermis,is effective in the treatment of psoriasis
15861955|NCT03946813|Other|Autologous PRP preparation|For each patient, autologous PRP preparation havs to be injected to both ovaries and ultrasound (US) guide
15861958|NCT03946787|Other|Eye Movement Desensitization and Reprocessing (EMDR) Therapy|The reprocessing and desensitization of each traumatic memory occurs in eight phases. In the first two phases, the therapist identifies targets and develops a treatment plan, enhances and develops personal resources, before working on traumatic memories. In stages 3 to 6, reprocessing and desensitization of memory is done. The patient focuses on the image of the event, negative beliefs and associated bodily sensations, while moving the eyes from side to side, following the therapist's fingers or other dual attention stimuli (eg, manual touch, auditory stimulation). Phases 7 and 8 are closing and reassessing, where the therapist determines if the memory has been processed properly.
15861959|NCT03946787|Other|Treatment as Usual|TAU will consist of the psychopharmacological approach appropriate to each patient according to the evaluation of a psychiatrist of childhood and adolescence's outpatient service.
15861960|NCT03946774|Dietary Supplement|Dietary protein shake|"It is a milk based protein shake. Ingredients include a combination of the following depending on protein content: Boost Plus (a commercial supplement), Unjury (a commercial whey protein isolate), nonfat dry milk powder, Sol Carb (commercial supplement composed of a carbohydrate polymer), canola oil, and water.
~In order to ensure consistency across all participants each beverage will be prepared in the Clinical Translational Research Unit Metabolic Kitchen under the supervision of a registered dietitian prior to the study participant's visit. Ingredients are individually weighed on a food scale by metabolic kitchen staff to the nearest 0.1 g and then mixed using a magnetic stir plate.
~Nutritional breakdown of the smoothies (high versus low protein):
~High protein drink nutrition: 500 kcal per serving, 50% protein, 17% fat, and 36% carbohydrate.
~Low (standard) protein drink nutrition: 500 kcal per serving, 10% protein, 17% fat, and 73% carbohydrate."
15861961|NCT03946761|Device|Cancer goggle system|-The cancer goggle system is being used as a non-significant risk device
15861962|NCT03946748|Drug|REGN3918|Single intravenous (IV) dose, then a subcutaneous (SC) dose once weekly (QW).
15861963|NCT03946735|Behavioral|Cognitive Behavioural Therapy as an Effective Treatment for Social Anxiety, Perfectionism, and Rumination|Week one involved introducing CBT and assessing the negative effects of perfectionism, rumination, and social anxiety. Week two allowed participants to specify stressful social activities, stressful social situations, and enjoyable activities. Week three to week six allowed participants to identify automatic thoughts and thinking errors (for example, all or nothing thinking, self-criticism, dysfunctional schemas for self-evaluation, and unrealistic standards). Assignments were provided to participants with the content of exposure to anxiety evoking situations in the treatment sessions and at home. Achievable behavioural goals were set for participants in the treatment sessions and at home.
15861964|NCT03946722|Drug|GnRH analogue downregulation|"Downregulation is the suppression of the ovaries during an IVF cycle in order to perform controlled ovarian stimulation and prevent premature ovulation.
~Participants will be exposed to one week of downregulation using a GnRH analogue in the standard downregulation arm and 6 weeks of downregulation using a GnRH analogue in the modified downregulation arm."
15862019|NCT03946189|Diagnostic Test|Obtaining arterial blood gases|Obtaining arterial blood sample
15862856|NCT03939481|Other|Functional Assessment|Functional and sensory clinician assessments
15861965|NCT03946722|Other|Participant questionnaire|Participant will be offered the opportunity to complete an adenomyosis symptom assessment questionnaire at the start of their treatment, and again two months after completion of treatment.
15861966|NCT03946709|Other|Action Observation|Strength, voluntary activation, and cortical responses to three conditions will be measured: 1) action observation of very strong, forceful contractions of the hand and wrist flexors 2) action observation of very weak, feeble contractions of the hand and wrist flexors 3) no action observation. Experimental conditions will be randomized and counterbalanced.
15861967|NCT03946696|Other|Interactions with therapy-animals|How people interact with humans and non-humans animals during and outside visits from therapy-animal teams.
15861968|NCT03946683|Radiation|Cyberknife for Early Stage Breast Cancer|Utilization of Cyberknife Robotic Radiosurgery as a 5-fraction post-lumpectomy adjuvant radiation treatment in the management of early stage breast cancer
15861969|NCT03946670|Drug|MBG453|MBG453 will be administered i.v.
15861970|NCT03946670|Drug|Placebo|Placebo will be administered i.v.
15861971|NCT03946670|Drug|Hypomethylating agents|Decitabine will be administered i.v. Azacitidine will be administered i.v or s.c.
15861972|NCT03946657|Drug|Inhalational anesthetic|Oxygen/air (fraction of inspired oxygen (FiO2) of 0.40), inspiratory fresh gas flow of 2 L/min), sevoflurane (1 minimum alveolar concentration [MAC]) and remifentanil IV infusion (0.1-0.25 mcg/kg of LBW/min) were used.Neuromuscular blockade was performed during the operation by rocuronium infusion (0.3-0.7 mg/kg of LBW/h), ensuring that PTC was zero.
15861973|NCT03946657|Drug|Intravenous anesthetic|Propofol infusion (4-8 mg/kg of total body weight/h), oxygen/air (FiO2 of 0.40; inspiratory fresh gas flow of 2 L/min) and remifentanil IV infusion (0.1-0.25 μg/kg of LBW/min) were used.Neuromuscular blockade was performed during the operation by rocuronium infusion (0.3-0.7 mg/kg of LBW/h), ensuring that PTC was zero.
15861974|NCT03946644|Device|EVLA with keeping of securuty distance|The EVLA will be performed with the 1470nm diode laser and a radial fibre (Leonardo® - 1470 nm/15W, Biolitec). The exact position of the catheter tip will be fixed under ultrasound guidance 2 cm below the SFJ.
15861975|NCT03946644|Device|EVLA without keeping a distance|The EVLA will be performed with the 1470nm diode laser and a radial fibre (Leonardo® - 1470 nm/15W, Biolitec). The exact position of the catheter tip will be fixed under ultrasound guidance without keeping a distance to the SFJ.
15861976|NCT03946631|Diagnostic Test|2 hour glucose tolerance test using 75g glucose drink|intervention is a 2 hour glucose tolerance test. Involves oral intake of a 75g glucose drink followed by using point of care testing. Glucose drink is taken after at least 6 hours of fasting. Fingerstick blood glucose testing done at three time points: fasting, one hour post drink and two hours post drink.
15861977|NCT03946618|Device|Medtronic Summit System, Olympus|Electrical brain stimulation with an implantable pulse generator
15861978|NCT03946592|Drug|Normal saline|Inject the Drug into submental fat via subcutaneous
15861979|NCT03946592|Drug|DWJ211|Inject the Drug into submental fat via subcutaneous
15861980|NCT03946579|Other|self questionnaires|FSFI, QLQ-C30, BR23, ELD15, HADS, GDS 15, FACIT, BIS
15861981|NCT03946566|Procedure|Acupuncture|Using acupuncture, electric acupuncture, moxibustion and acupoint injection treatment.
15861982|NCT03946527|Drug|Lanreotide|Participants will receive lanreotide 120 mg deep subcutaneous injection every 4 weeks (±7 days) for 52 weeks, followed by an extension phase in which all patients will continue to receive lanreotide 120 mg injection every 4 weeks (±7 days) if there is no evidence of disease progression.
15861983|NCT03946514|Drug|losartan/hydrochlorothiazide|losartan 100 mg/hydrochlorothiazide 25 mg single-pill combination
15861984|NCT03946514|Drug|amlodipine/hydrochlorothiazide|amlodipine besylate tablets (5 mg / tablet) + hydrochlorothiazide tablets (25 mg / tablet)
15861985|NCT03946501|Other|Data collection|
15861986|NCT03946488|Device|Functional electrical stimulation|Functional electrical stimulation of finger's muscles in order to open the hand
15861987|NCT03946475|Other|Intervention group|"Training of Trainers (ToT) was conducted among teacher who would deliver the messages. Remaja ASIK is Indonesian tagline meant girls who are active, healthy, smart, and creative. Nutrition education was performed in every Friday, at least 30 minutes during 20 weeks. In brief, this is the key messages of optimized food based recommendations: 1) 3 meals and 2 snack every day, 2) At least 2 portions of vegetables/day including at least 5 portions/week of green leafy vegetables, 3) At least 2 portions/day of animal protein including at least 2 portions/week of liver, 4) At least 1 portion/day of tempe or tofu, 5) At least 1 portion/day of fruit, 6) At least 3 portions/week of milk.Trained teachers delivered the messages accompanied by supervisor. The delivered topics were key messages, balance nutrition, anemia, menstruation, BMI, healthy and smart, strong bone, lunch box, safe snack, and food label."
15861988|NCT03946462|Drug|NO gas delivered during cardiac surgery|intra-operative NO gas at 20ppm blended into the fresh gas flow of the CPB oxygenator via the INOMax delivery system.
15861989|NCT03946462|Other|placebo gas delivered during cardiac surgery|placebo blended into the fresh gas flow of the CPB oxygenator via the INOMax delivery system. The placebo gas in this study will be 21% (or atmospheric) oxygen.
15861990|NCT03946449|Drug|ARO-AAT Injection|solution for subcutaneous (sc) injection
15861991|NCT03946436|Device|Active video games|Participants played the active video game Virtua tennis 4 on a playstation kinect device
15861992|NCT03946436|Other|tennis training process|Participants were involved in a regular tennis training process, performed two times a week for one hour per lesson.
15861993|NCT03946423|Procedure|Bariatric Surgery with Sleeve Gastrectomy|Standard of care bariatric surgery with sleeve gastrectomy
15861994|NCT03946423|Behavioral|Lifestyle Intervention|All participants receive lifestyle intervention. The lifestyle intervention program is modeled closely after that used in the Diabetes Primary Prevention Trial and the LookAHEAD diabetes treatment studies. Intervention includes counseling sessions weekly for the first six months, twice a month during months 7-9, and monthly during months 10-12, and energy intake and exercise goal monitoring and guidance.
15861995|NCT03946410|Diagnostic Test|Invitation to screening|Invitation to CVD screening with non contrast CT scanning, ABI measurement and blood tests
15861996|NCT03946397|Other|Mulstisensory massage|7 minutes of hand massage followed by multisensory immersion (lights and music) for 23 minutes
15861997|NCT03946384|Other|data collection|data collection on the history of the disease, hemophilia
15862121|NCT03945318|Drug|BION-1301 Single Dose|A solution for IV infusion administered as a single dose.
15861998|NCT03946358|Biological|Blood sample collection|"Four blood samples will be collected at:
~baseline
~2 months from inclusion (+/- 1 week)
~4 months from inclusion (+/- 1 week)
~the end of vaccination visit (+/- 1 week).
~A total of 8 EDTA (ethylenediaminetetraacetic acid) tubes of 6 ml will be collected at each time point to perform:
~PBMC collection: 6 EDTA tubes of 6 ml of peripheral blood mononuclear cell [PBMC] will be sent to the central laboratory (Biomonitoring Platform of Besançon, CHRU de Besançon located at Etablissement Français du Sang) at room temperature within 24 hours via an approved carrier for their processing, storage and immunomonitoring analysis. A sending sheet of the samples will be attached to each single sample.
~Plasma collection: One 6 ml EDTA tube should be frozen in each investigation center for plasma collection.
~Plasma for circulating tumoral DNA (ctDNA) collection: One 6 ml EDTA tube should be frozen in each investigation center for ctDNA collection."
15861999|NCT03946358|Procedure|Tumor biopsies|A tumor biopsy will be realized and centralized at baseline and at 2 months. Collection of tumor biopsies will be guided by ultrasound or CT scan
15862000|NCT03946358|Other|CT scan|"A CT scan will be planned
~at baseline
~at tumor evaluation visit (8 weeks)
~every 8 weeks (+/- 1 week)
~at end of treatment visit."
15862001|NCT03946358|Drug|Atezolizumab|"Induction phase: Atezolizumab 1200 mg intravenous every 3 weeks since day 1
~Boost phase: Atezolizumab 1200 mg intravenous every 3 weeks until disease progression or unacceptable toxicity until disease progression or unacceptable toxicity."
15862002|NCT03946358|Drug|UCPVax|"Induction phase: UCPVax (combined with Montanide ISA51 as adjuvant) at 1 mg subcutaneously in two separate sites (one site per peptide) at day 1, 8, 15, 29, 36 and 43 (induction phase).
~Boost phase: UCPVax boosts vaccine every 6 weeks for the 2 first boosts (boost 1 and boost 2) and then every 9 weeks (boost 3 to boost 5)."
15862003|NCT03946345|Drug|Iohexol Inj 300 MG/ML|"Administration of iohexol: each 24 hours one bolus IV (1-5ml) during 72 hours
~Blood samples are drawn for analysis of iohexol concentrations and other parameters of renal function at 2, 5 and 7 hours after administration
~Urine is collected from catheter between 4 and 6 hours after adminstration to determine urine creatinine and iohexol concentrations"
15862004|NCT03946332|Behavioral|Physical exercises|patients will benefit regularly from a physical exercises program during their hospitalization. When going back home, they will be given a practical help kit with specific equipment (dumbbell, elastic), an actimeter with heart rate monitoring (in order to have an objective collection of the physical practice in addition to a self-evaluation) and a physical exercises program on paper and video supports, that patients would have learnt during their hospitalization.
15862005|NCT03946332|Behavioral|Optional physical exercises|patients will be proposed for the physical exercises and will practice them if they want.
15862006|NCT03946319|Diagnostic Test|Introspect Health|Introspect Health is a software platform which has implemented both the monotopic and personalized, transdiagnostic assessment tools. The software is delivered via the internet using a mobile device or computer.
15862007|NCT03946306|Drug|5,25% NaOCl with syringe needle irrigation alone|In group 1 (control group), a final irrigation will be made with 1.5 ml of NaOCl per canal, during 30 seconds in an up-and-down motion, with the needle 1 mm short of the working length, without binding. After this, a 30 seconds pause will be done. This step will be repeated once again.
15862008|NCT03946306|Device|EDDY|In group 2, a final irrigation will be made with 1.5 ml of NaOCl per canal and the irrigant will be activated using EDDY tips, 1 mm short of the working length without binding. The activation will be performed during 30 seconds, followed by a 30 seconds pause, and the cycle will be repeated once again, according to manufacture instructions.
15862009|NCT03946293|Dietary Supplement|White Bread|White bread made with commercial white flour with bran/fibre removed
15862010|NCT03946293|Dietary Supplement|Wholegrain bread|Wholegrain bread made with commercial wholegrain flour.
15862011|NCT03946293|Dietary Supplement|Wholegrain Enzyme|Wholegrain bread made with enzyme-treated commercial wholegrain flour.
15862012|NCT03946280|Procedure|conventional X-ray based Fluoroscopy|catheter tracking via conventional X-ray based Fluoroscopy
15862013|NCT03946280|Procedure|low X-ray 3D navigation technique|catheter tracking via low X-ray 3D navigation technique
15862014|NCT03946267|Device|Inverted inner limiting membrane flap technique for large full thickness macular holes|The ILM, stained with IFCG or BBG, is peeled off with ILM forceps, usually beginning near the inferotemporal vascular arcade, at least 2 disk diameters from the macular hole, in a circular manner. The peeling is extended up to the edges of the macular hole, the wide ILM flap obtained reduced by trimming with the vitreous cutter, and the annular remnant of ILM hinged to the hole's edge gently inverted upside down facing the RPE. Therefore, the hole is covered with usually more layers of inverted ILM. Attention is paid to avoid insertion and filling of the hole volume with ILM.
15862015|NCT03946254|Other|Effect of strength training on executive functions in elderly people with mild cognitive impairment.|Strength training sessions will have a frequency of 3 times per week (Monday, Tuesday and Wednesday) for 20 weeks. In addition, each subject is subject to an individualized training program according to the workload in order to progressively increase the intensity of work. The workload will be modified progressively by influencing both the total volume of repetitions and the intensity of the exercises. The exercises will be controlled movements and not harmful, as guided machines will be used to facilitate the execution of actions. In addition, the largest amount of muscle groups to be able to generate strength gains in all muscle groups. The control group will perform breathing exercises and low intensity stretching during the same days and with the same duration as the experimental group
15862016|NCT03946228|Behavioral|Behavioral Intervention|The intervention will be delivered by trained research staff who are exercise physiologists or behavioral lifestyle counselors. This target reflects a recent expert statement concluding that desk-based workers should reduce workday sedentary behavior by 2-4 hr (by increasing standing and movement). The approach will combine: behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts. The initial in-person session will occur at the participant's office location. During months 2 and 3, one-on-one in-person meetings will occur at the research lab. Telephone intervention contacts will occur in the 3rd week of months 1-3.
15862017|NCT03946215|Other|Each participant will perform:|Part 1: Maximal incremental tests will require running at fixed slopes (+15%, 0% -15%) for stages (2min duration) of increasing velocities (0.5, 1 and 1.5 km/h) Part two: submaximal running tests will require running at constant velocity (80% VO2max uphill; 80%VO2max downhill and downhill at similar velocity as uphill)
15862020|NCT03946176|Dietary Supplement|Symbiotic|HD patients follow a 8-weeks oral administration of the symbiotic supplement (2 bags/day)
15862021|NCT03946176|Dietary Supplement|Placebo|HD patients follow a 8-weeks oral administration of the placebo (2 bags/day)
15862022|NCT03946176|Device|DVB cartridge|On the last week of the symbiotic/placebo period, patients undergo 3 dialytic sessions with the DVB cartridge
15862023|NCT03946163|Dietary Supplement|cinnamon capsules|each patient will receive sixty capsules, each capsule contained 1gm of cinnamon bark powder and instructed to use it twice daily for one month
15862024|NCT03946163|Drug|Placebo oral capsule|each patient will receive sixty capsules, each capsule contained placebo and instructed to use it twice daily for one month
15862025|NCT03946150|Diagnostic Test|P/FP Ratio|PaO2/Fio2 X PEEP
15862026|NCT03946137|Other|Chest Therapy|The sessions of chest therapy were based on airway clearance techniques (hyper manual insufflations, abdominal thoracic compressions and manually assisted cough)
15862027|NCT03946137|Other|Postural Hygiene|Postural hygiene workshops were taught through a theoretical presentation with the help of slides and practical exercises in small groups (2-4 parents per group).
15862028|NCT03946124|Drug|Fesoterodine|Fesoterodine, the drug used in this study, is an appropriate medication for routine and standard care of overactive bladder.
15862029|NCT03946111|Drug|Naltrexone and Bupropion|Participants randomly assigned to this arm will receive 12 weeks of Naltrexone and Bupropion medication.
15862030|NCT03946111|Other|Placebo|Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
15862031|NCT03946098|Behavioral|iCBT|A newly developed iCBT protocol targeting problem gambling.
15862032|NCT03946085|Dietary Supplement|Lumega-Z|A specially-formulated carotenoid supplement formula that utilizes a micronized, lipid-based liquid form of delivery.
15862033|NCT03946085|Dietary Supplement|AREDS2|A commercially-available multivitamin soft gel formula.
15862034|NCT03946072|Procedure|Transseptal Aortic Approach Catheter Ablation Procedure|The transseptal approach entails obtaining femoral venous access, and, guided by fluoroscopy and intra-cardiac ultrasound, starting with a transseptal needle or RF device inside the dilator of a long sheath; pulling down until the fossa ovalis in the interatrial septum is engaged on both fluoroscopy and intracardiac echo imaging; once on the left side, the long sheath is advanced over the transseptal needle, the needle and dilator are removed, and the ablation catheter can then be advanced across the mitral valve into the left ventricle.
15862035|NCT03946072|Procedure|Retrograde Aortic Approach Catheter Ablation Procedure|The retrograde aortic approach entails obtaining femoral arterial access and leaving a sheath in the femoral artery. Under fluoroscopy, an ablation catheter is then advanced up the ascending aorta where the catheter tip is curved using an internal mechanism controlled on the handle of the catheter to form a large loop (to prevent the tip from traveling down a coronary artery and causing trauma such as a dissection); the curved loop is advanced around the aortic arch and down the ascending aorta. To cross the aortic valve with this loop, the catheter is typically torqued in various directions until it falls through the aortic valve and into the left ventricle.
15862036|NCT03946059|Device|iTBS then cTBS|repetitive transcranial magnetic stimulation applied with intermittent theta-burst stimulation protocol applied in week 1 and continuous theta-burst stimulation protocol applied in week 2.
15862037|NCT03946059|Device|cTBS then iTBS|repetitive transcranial magnetic stimulation applied with continuous theta-burst stimulation protocol applied in week 1 and intermittent theta-burst stimulation protocol applied in week 2.
15862038|NCT03946046|Procedure|Clinical targeting|The intervention consists of the injection of botulinum toxin A into muscles targeted by a clinical localization method (observation and palpation of target muscles)
15862039|NCT03946046|Procedure|Ultrasonography targeting|The intervention consists of the injection of botulinum toxin A into muscles by ultrason-guided method
15862040|NCT03946033|Diagnostic Test|Immunoscore Colon Test|Immunoscore Colon is a CE-marked in-vitro diagnostic test, allowing the quantification of CD3 and CD8 positive cells in formalin-fixed paraffin-embedded (FFPE) tissue samples of primary colon cancer. The test uses immunohistochemistry, digital pathology techniques and a dedicated software.
15862041|NCT03946020|Procedure|Guided bone regeneration with or without autologous bone|Autogenous bone chips were collected. On each side a bone level implant was placed. The bone dehiscence was measured and was thereafter treated according to the GBR protocol. A resorbable native collagen was adapted to the defect.
15862042|NCT03945994|Other|Connecting People Intervention|Improve the resourcefulness of social networks of people with mental health problems
15862044|NCT03945955|Dietary Supplement|Melatonin|Participants will be randomized into two groups (Group A and Group B). Group A will initially be treated with 3 mg melatonin supplements over a 4-week period while Group B will initially receive placebo supplements over a 4-week period. After a 4-week washout period, Group A will receive placebo supplements while Group B will receive 3 mg melatonin supplements.
15862045|NCT03945955|Other|Placebo|Placebo
15862046|NCT03945942|Device|Near infrared spectroscopy with INVOS device|somatic and cerebral oximetry by INVOS in pediatric liver transplantation
15862047|NCT03945942|Device|Near infrared spectroscopy with Foresight device|somatic and cerebral oximetry with Foresight device in pediatric liver transplantation
15862048|NCT03945929|Behavioral|Distraction|"Distraction-1 Group: Cards containing approximately six optical illusion pictures were shown to the patients and as a method of distraction during the PIC insertion procedure they were asked what they saw in these cards.
~Distraction-2 Group: Underwater 3D audial videos were played with visual reality (VR) goggles during PIC insertion until the procedure was completed."
15862049|NCT03945916|Dietary Supplement|Dark chocolate|180 g/d dark chocolate for 15 days followed by exercise testing
15862050|NCT03945916|Dietary Supplement|Placebo|Placebo: 180 g/d imitation dark chocolate for 15 days followed by exercise testing
15862051|NCT03945903|Drug|Golimumab|Participants will receive subcutaneous (SC) golimumab, where doses will be based on weight and/or body surface area.
15862052|NCT03945877|Other|No interventions|No interventions
15862122|NCT03945318|Drug|Placebo Single Dose|A solution by IV infusion administered as a single dose.
15862053|NCT03945864|Device|antimicrobial synthetic bone graft|It will be determined whether the silver ion-doped antimicrobial synthetic bone graft that has the capacity to fill the bone voids also has the capacity to treat the infection in the bone in 12 patients with chronic osteomyelitis
15862054|NCT03945864|Device|parentaral antimicrobials and pure bone grafts|Historical data of the department will be used for comparison of the results
15862055|NCT03945851|Procedure|fMRI|All subjects will undergo 2 fMRI sessions. Each of these sessions will span two days, and subjects will spend 15 minutes in the MRI each day. fMRI tasks will consist of subjects grasping and releasing a handgrip. The control arm subjects will be offered a third fMRI session after unblinding and therapy with activation of the VNS.
15862056|NCT03945838|Other|Complete Decongestion Therapy|"It is given in two phases. First phase includes intensive therapy which aims to reduce the volume of the extremity. Second phase aims to preserve these reductions of volume.
~All patients were prescribed lymphedema specific exercises and were advised to walk (for 30 minutes everyday) daywhile taking complete decongestive therapy. They were specifically informed that exercise does not aggravate the severity of their lymphedema.
~Short stretch bandages were applied to the patients with self manual lymphatic drainage. Intensive phase was given 5 days a week, and short stretch bandages applied for 23 hours a day with 1 hour interval. To increase the local pressure on the areas required, foams were added. Patients were screened with arm circumferential measurements once a week. After gaining a plateau in the volumes, patients were prescribed compression garments."
15862057|NCT03945825|Drug|AF03|A squalene-in-PBS emulsion stabilized by nonionic surfactants, sorbitan oleate and macrogol cetostearyl ether
15862058|NCT03945825|Biological|Delta Inulin-CpG55.2|A combination adjuvant supplied as two separate components, Delta Inulin (Sypharma Pty Ltd.) and CpG55.2 (Nikko Denka Avecia and Sypharma Pty Ltd)
15862059|NCT03945825|Biological|Influenza Virus Quadrivalent Inactivated Vaccine|2018/2019 Fluzone QIV and 2019/2020 Fluzone QIV vaccines will be given with 90 days interval
15862060|NCT03945825|Biological|Quadrivalent Recombinant Seasonal Influenza Vaccine|2018/2019 Flublok QIV and 2019/2020 Flublok QIV vaccines will be given with 90 days interval
15862061|NCT03945812|Drug|Granulocyte Colony Stimulating Factor|Filgrastim, Amgen, California, USA 300 mg/1.0 mL
15862062|NCT03945812|Other|Platelet Rich Plasma Arm|Platelet Rich Plasma Arm
15862063|NCT03945812|Other|Saline|Saline 9%
15862064|NCT03945799|Drug|Anlotinib Hydrochloride|Anlotinib: 12mg QD PO d1-14, 21 days per cycle, 8 cycles.
15862065|NCT03945773|Drug|Cabozantinib|Oral tablets of 60mg, 40mg and 20 mg.
15862066|NCT03945760|Drug|Baricitinib|Baricitinib 2 mg
15862067|NCT03945760|Drug|Placebo|Placebo
15862068|NCT03945747|Diagnostic Test|Blood draw|Participants will undergo a blood collection for hemoglobin A1c, adiponectin, total cholesterol, LDL, HDL, triglycerides, and c-peptide at baseline and follow up in 3-6 months.
15862069|NCT03945747|Diagnostic Test|Urine sample collection|Participants will undergo urine sample collection for urine microalbumin and urine creatinine at baseline and follow up in 3-6 months.
15862070|NCT03945747|Diagnostic Test|DXA scan|Participants will undergo a DXA scan for lean and fat mass measurements at baseline and follow up in 3-6 months.
15862071|NCT03945734|Behavioral|Expressive Helping|Expressive helping harnesses the benefits of helping others (e.g., support giving) through writing or voice-recording. Expressive helping integrates two distinct areas of research showing that writing or speaking about ones' negative experiences and engaging in support giving behaviors can improve psychological well-being.
15862074|NCT03945708|Device|CytoSorb|Addition of a hemofilter to the cardiopulmonary bypass circuit
15862075|NCT03945695|Procedure|"Pneumatic Vitreolysis in combination with Drinking-Bird-Technique"|"Appropriate anesthesia and antiseptic preparation of the surgical field
~Prophylactic paracentesis of the anterior chamber
~One intravitreal injection of 0.2 to 0.3 ml of filtered sulfur hexafluoride gas (SF6) into the test eye Remark: Intraocular pressure of the examined eye is to be controlled before the intervention and kept at an appropriate level after paracentesis by manual application of pressure.
~Patients are instructed to avoid supine position and to lie on one side or the abdomen during sleep until complete resorption of intraocular gas occured. In this period they should bend over several times during the day up to an angle of 90º or as much as possible, resembling the movement of a bird drinking water. (Hence the name drinking-bird-technique.)"
15862076|NCT03945682|Other|Therapist|Intervention therapist at 2 centres providing 8 week intervention programme 50% embedded qualitative study
15862077|NCT03945669|Procedure|Intramedullary Nailing|fracture fixation of the tibial shaft fracture with an intramedullary nail.
15862078|NCT03945669|Procedure|External Ring fixation|fracture fixation of the tibial shaft fracture with an external ring fixator.
15862079|NCT03945656|Drug|insulin icodec|Participants will receive subcutaneous (s.c.) injections of insulin 287 OW for 6 weeks
15862080|NCT03945656|Drug|Insulin glargine|Participants will receive daily s.c. injections of insulin glargine U100 for 12 days
15862081|NCT03945643|Drug|Sildenafil|50mg administration of sildenafil, one time, one hour prior to measurements.
15862082|NCT03945643|Other|Placebo|50mg administration in gel-encapsulated microcrystalline cellulose one time, one hour prior to measurements.
15862083|NCT03945630|Procedure|anterior Quadratus Lumborum Block|Interfascial plane block
15862084|NCT03945630|Procedure|Standard of Care|No QLB
15862085|NCT03945617|Behavioral|Unified Treatment Protocol|The Unified Treatment Protocol (UP) is a transdiagnostic psychotherapeutic treatment manual for emotional disorders, that is based on CBT principles and focuses on changing dysfunctional emotion regulation.
15862086|NCT03945604|Drug|SHR-1210 + Apatinib +Fluzoparib|SHR-1210 will be administered as an intravenous infusion Apatinib tablets will be given orally Fluzoparib capsule will be given orally 28 days per cycle, until disease progression or unacceptable toxicity.
15862087|NCT03945591|Drug|Bortezomib|1.3 mg/m2 IV 6 hours after graft infusion and 72 hours thereafter.
15862088|NCT03945591|Drug|Cyclophosphamide|50 mg/kg IV over 2 hours on Day +3 and +4
15862089|NCT03945578|Other|Pelvic Floor muscle training - PFMT|Pelvic Floor muscle training is an active exercise-based treatment designed to strengthen the pelvic floor muscles. The PFMT protocol was divided into four phases. Proprioceptive (2 weeks): where the woman has gained adequate perception of PFM and control of fast and slow contractions; Simple (1 week): performed with the objective of promoting control of fast and slow contractions associated with small functional exercises; Elaborated (1 week): where the exercise evolved into functional exercises of greater amplitude; and Power (1 week): where the control of the pelvic floor was promoted during efforts. In all sessions, contractions were performed for slow and for fast fibers (the list of exercises and a detailed description of them is in Appendix 1).
15862090|NCT03945578|Other|Visceral Manual Therapy - VMT|Visceral manual therapy:is a manual treatment intended to the release of visceral fascias. The VMT protocol was based on the work proposed by Vanderheyden-Busquet (2014). To act on the abdominal and pelvic visceral fasciae, the VMT was performed through slow and deep mobilizations, respecting the participant's tissue resistance and painful response, in different regions of the abdômen.
15862091|NCT03945578|Other|Manual Sham Therapy - MST|The manual sham therapy protocol was perfomed by gentle techniques applied to the thoracic spine, scapular waist and cervical spine
15862092|NCT03945565|Other|Fraction of inspired oxygen level|A fraction of inspired oxygen level during off-pump coronary artery bypass grafting will be set differently between the study groups: 0.3 vs 0.8.
15862093|NCT03945552|Behavioral|Video Interaction Project|VIP is a strengths-based, family-centered intervention that uses pediatric well-child visits to enhance parenting practices/relationships and child development by promoting positive parenting practices such as pretend play, shared reading, and daily routines.
15862094|NCT03945539|Drug|JNJ-56136379|Participants will receive JNJ-56136379 orally on Day 1 in Treatment Period 1 and on Day 38 in Treatment Period 2.
15862095|NCT03945539|Drug|Itraconazole|Participants will receive 200 mg of itraconazole once daily orally for 21 days starting on Day 34.
15862096|NCT03945526|Drug|Astaxanthine|
15862097|NCT03945526|Drug|Placebo Oral Tablet|
15862098|NCT03945513|Drug|LPRI424 (dienogest/ethinylestradiol)|One LPRI424 tablet once per day for 24 days followed by 4 placebo tablets for 4 days equals one cycle.
15862099|NCT03945500|Device|Investigational Mobile Medical Software Application & IT Dashboard Application, FDA approved Bluetooth spirometer, FDA approved pulse oximeter|"Standardized Home Spirometry (SHS) Method consists of an Investigational Mobile Medical Application embedded into an Android Tablet, an FDA approved Bluetooth spirometer, an FDA approved pulse oximeter. HIPAA compliant data will be sent to an Investigational IT dashboard maintained at the Central Monitoring Institute Server.
~Volunteers will train in-center or remotely & perform baseline testing with the SHS method along with a baseline laboratory-based spirometry test (if practicable).
~Pre-Surveillance Phase: Daily home spirometry method testing for 4 to 10 weeks to enable normal range calibration.
~Surveillance Phase: At least weekly home spirometry method testing for 2-10 months of participation. Volunteers will maintain a test log during study team directed SHS software pathway functionality testing."
15862100|NCT03945487|Biological|umbilical cord-derived mesenchymal stem cell|Taken a dose of 1.0*10E6 UC-MSC/kg body weight intravenously three times at 3-week intervals, in addition to comprehensive treatment.
15862101|NCT03945487|Other|Comprehensive treatment|"All patients received anti-HBV treatment with NAs (entecavir (ETV), tenofovir disoproxil fumarate (TDF), or tenofovir alafenamide (TAF)).
~Strategies based on targeting abnormalities in gut-liver axis by antibiotic administration (i.e. rifaximin), improving the disturbed systemic circulatory function (i.e. longterm albumin administration), decreasing the inflammatory state (i.e. statins), and reducing portal hypertension (i.e. beta-blockers)."
15862102|NCT03945474|Other|Sham|See description in sham arm.
15862103|NCT03945474|Other|Osteopathic Manipulation, OMT|See description in OMT arm
15862104|NCT03945461|Other|Chewing gum|xylitol based, peppermint flavored gum
15862105|NCT03945448|Drug|Single dose liposomal Amphotericin and Fluconazole|Intravenous Single dose of 10mg/kg of Ambisome and fluconazole as per WHO guidelines for six months.
15862106|NCT03945448|Drug|Fluconazole|Fluconazole 800mg for 2 weeks,400mg for 8 weeks and 200mg up to six months
15862107|NCT03945422|Device|AccuTite/FaceTite|Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
15862108|NCT03945409|Device|OPTIVENT|OPTIVENT (SIDAM SRL, Mirandola, Italy) is a new fully automated and self-calibrating system that allows a real-time monitoring and recording of airway pressure and esophageal pressure during mechanical ventilation. The system required the insertion of an esophageal balloon catheter and an airway pressure transducer.
15862109|NCT03945396|Drug|Homeopathic Medication|A homeopathic mineral medicine, form of impure calcium carbonate, CaCO3, which can be found in nature in different niches, from limestone to eggshells.
15862110|NCT03945396|Other|Multidisciplinary intervention (Exercise program, diet, motivational support)|"Exercise program: includes a five-times per week routine: warm-up during 10 to 15 minutes, then 40 minutes of aerobic exercise that will be increased progressively until reaching 60 minutes. Thereafter, muscular strength initiating 5%, and increasing until 10 to 15% of body weight. Then, 10 to 15 minutes of stretching. Finally, 5 min cool-down.
~Diet: Subjects will receive a balance diet calculated based on energetic needs according FAO: 15-20% of proteins, 50-60% of carbohydrate, 20-25% of fat per day.
~Motivational support: 50 min session where empathy and neutral understanding of the perspective and feelings of the adolescent, and his family, are fostered to motivate the change and to state realistic goals in reducing weight."
15862111|NCT03945396|Drug|Homeopathic placebo|A 30 ml bottle of 30% alcohol-distilled water.
15862112|NCT03945383|Device|Treatment with IPL device|Treatment with IPL device
15862113|NCT03945370|Dietary Supplement|β-hydroxybuturate esters|Oral dietary supplement product containing β-hydroxybuturate esters
15862114|NCT03945370|Dietary Supplement|Placebo drink|Oral placebo drink
15862115|NCT03945357|Drug|Gemcitabine/ clindamycin|Comparison of saline solution rinse vs antibiotic rinse
15862116|NCT03945357|Drug|Normal saline|Comparison of saline solution rinse vs antibiotic rinse
15862117|NCT03945344|Drug|Tiotropium|Oral capsule 20 μg
15862118|NCT03945344|Drug|Tiotropium|Oral capsule 20 μg
15862119|NCT03945331|Device|Transcutaneous spinal cord stimulator|DS8R Electrical Stimulator For Human Research
15862120|NCT03945331|Device|Epidural spinal cord stimulation system|Spectra WaveWriter Epidural Spinal Cord Stimulator System with CoverEdge 32 Electrode Surgical Lead
15862123|NCT03945318|Drug|BION-1301 Multiple Doses|A solution for IV infusion administered as multiple doses.
15862124|NCT03945318|Drug|Placebo Multiple Doses|A solution by IV infusion administered as multiple doses.
15862125|NCT03945305|Device|Remote Ischemic Conditioning|Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 30±2 days.
15862126|NCT03945292|Drug|ARO-AAT Injection|solution for subcutaneous (sc) injection
15862127|NCT03945292|Other|Placebo|sterile normal saline (0.9% NaCl), calculated to match active comparator, for sc injection
15862128|NCT03945279|Drug|BIIB100|Administered as specified in the treatment arm.
15862129|NCT03945279|Drug|Placebo|Administered as specified in the treatment arm.
15862130|NCT03945266|Behavioral|Intervention group|During the intervention, all participants will start out at the Baseline level. The baseline level will last 2 weeks and there will be an assessment to determine weight gain over those 2 weeks. If weight gain has succeeded the recommended amount, participants will be adapted up to a new level of intervention that includes education on GWG, healthy eating and physical activity. After every 4 weeks, an assessment will be performed and adaptations up will be made if necessary. Adaptations include addition of exercise sessions, healthy eating recipe demonstrations, and meal replacements. Participants will weigh themselves daily, wear an activity monitor, record their diet, and complete paper and online surveys.
15862131|NCT03945266|Behavioral|Control group|Participants will follow the same self-monitoring/assessment schedule but will not receive the GWG, healthy eating, and physical activity education or adaptations.
15862132|NCT03945253|Drug|ASP8374|Intravenous
15862133|NCT03945240|Procedure|Group 1 -- using Pinnacle Series Laser Device|"Utilizing the Pinnacle Series Laser by Aspen Laser Systems, investigators will apply 635-780nm, 10 mW cw, ~ 5-105 J/cm2 at the following time and mW intervals. The beam will be applied at 12 application patterns equidistant and parallel to each other. Each application point will be treated for the timeframes referenced below:
~Subgroup 1: 10 minutes at 5 mW
~Subgroup 2: 10 minutes at 15 mW
~Subgroup 3: 10 minutes at 32 mW
~Subgroup 4: 15 minutes at 5 mW
~Subgroup 5: 15 minutes at 15 mW
~Subgroup 6: 15 minutes at 32 mW"
15862134|NCT03945240|Procedure|Group 2 -- using Pinnacle Series Laser Device|"Utilizing the Pinnacle Series Laser by Aspen Laser Systems, we will apply 830nm, 30- 50mW cw, ~ 1-20 J/cm2 at the following time and mW intervals. The beam will be applied at 12 application patterns equidistant and parallel to each other. Each application point will be treated for the timeframes referenced below:
~Subgroup 1: 10 minutes at 5 mW
~Subgroup 2: 10 minutes at 15 mW
~Subgroup 3: 10 minutes at 32 mW
~Subgroup 4: 15 minutes at 5 mW
~Subgroup 5: 15 minutes at 15 mW
~Subgroup 6: 15 minutes at 32 mW"
15862135|NCT03945240|Procedure|Group 3 -- using Phoenix Thera-Lase Device|"Utilizing the Phoenix Thera-Lase by Phoenix Thera-Lase Systems, we will apply 904nm, 40mW (pulsed) @10000Hz, ~ 4-18 J/cm2 at the following time and mW intervals. The beam will be applied at 12 application patterns equidistant and parallel to each other. Each application point will be treated for the timeframes referenced below:
~Subgroup 1: 10 minutes at 5 mW
~Subgroup 2: 10 minutes at 15 mW
~Subgroup 3: 10 minutes at 32 mW
~Subgroup 4: 15 minutes at 5 mW
~Subgroup 5: 15 minutes at 15 mW
~Subgroup 6: 15 minutes at 32 mW"
15862136|NCT03945227|Drug|standard platinum-based concurrent chemoradiotherapy, followed by consolidation with PDR001|drug: standard platinum-based concurrent chemoradiotherapy, followed by consolidation with PDR001 Arm A (consolidation only arm) will be treated with standard platinum-based concurrent chemoradiotherapy, followed by consolidation with PDR001 regimen. --For concurrent chemoradiation therapy, chemotherapeutic agents will follow the one of the two regimens of standard of care Paclitaxel 45 mg/m2 at D1, D8, D15, D22, D29, and D36, IV infusion; Carboplatin AUC 2 at D1, D8, D15, D22, D29, and D36, IV infusion Etoposide 50 mg/m2 D1-5, D29-33,IV infusion; Cisplatin 50 mg/m2 D1, D8, D29, and D36; IV infusion - Concurrent radiation therapy (generally, 60 Gy/30 Fx ±10%) - Consolidation therapy: after 2 weeks after completion of radiation therapy (± 7 days), PDR001 400 mg every 4 weeks, until disease progression or an unacceptable adverse event, maximum 12 months.
15862137|NCT03945227|Drug|PDR001 concurrent with standard platinum-based chemoradiation, followed by consolidation with PDR001|drug:PDR001 concurrent with standard platinum-based chemoradiation, followed by consolidation with PDR001 Arm B (concurrent arm) will be treated with PDR001 concurrent with standard platinum-based chemoradiation, followed by consolidation with PDR001 regimen. -For concurrent chemoradiation therapy, chemotherapeutic agents will follow one of the two regimens of standard of care Paclitaxel 45 mg/m2 at D1, D8, D15, D22, D29, and D36, IV infusion; Carboplatin AUC 2 at D1, D8, D15, D22, D29, and D36, IV infusion Etoposide 50 mg/m2 D1-5, D29-33,IV infusion; Cisplatin 50 mg/m2 days 1,8,29, and 36; IV infusion - Concurrent PDR001 400mg at D1, D29 - Concurrent radiation therapy (generally, 60 Gy/30 Fx ±10%) - Consolidation therapy: after 4 weeks after last dose of PDR001, PDR001 400 mg every 4 weeks, until disease progression or an unacceptable adverse event, maximum 12 months.
15862138|NCT03945214|Behavioral|Meditation|10 minute per day, 8 week digital meditation
15862139|NCT03945214|Behavioral|Healthy Eating|A single 50 minute counseling session focused on eating behaviors, and three 10-minute follow-up phone calls to check-in on eating goals
15862140|NCT03945214|Behavioral|Meditation + healthy eating|10 minute per day, 8 week digital meditation and a single 50 minute counseling session focused on eating behaviors, and three 10-minute follow-up phone calls to check-in on eating goals
15862141|NCT03945201|Other|Virtual walking trails|During time on the treadmill, participants walk in front of Bionautica Trails, the virtual walking trails created by Plas.md. Participants can select between seven trails including various nature themed trails and a space setting. While walking, participants wear wireless headphones that provide audio of cardiac rehabilitation education at random intervals. These education pieces cover six categories of information: Understanding Your Heart Condition, Diet, Exercise, Medication, Managing Risk Factors, and Emotional Health.
15862142|NCT03945201|Other|Standard of care|"Participants receive normal standard of care cardiac rehabilitation, completing multiple pieces of exercise equipment at increasing intervals according to the Jefferson Methodist Cardiac Rehabilitation program's protocols. Participants are given the option to use the treadmill for up to 15 minutes."
15862143|NCT03945188|Drug|Etrasimod|Etrasimod 2 mg tablet by mouth, once daily up to 52 weeks of treatment
15862144|NCT03945188|Drug|Placebo|Etrasimod matching placebo tablet by mouth, once daily up to 52 weeks of treatment
15862215|NCT03944759|Procedure|serratus anterior plan block|serratus anterior plan block
15862145|NCT03945175|Drug|MYDAYIS|MYDAYIS treatment will be given at a minimum dose of 12.5mg/day and will increase in increments of 12.5mg, up to 37.5mg, based upon clinical response and tolerability.
15862146|NCT03945162|Combination Product|TLD-1433 Bladder infusion and Photodynamic Therapy|TLD1433 is infused into the bladder, followed by repeated rinsing and treatment of bladder wall with photodynamic therapy (PDT).
15862147|NCT03945149|Dietary Supplement|Turmipure Gold™|30 subjects will take 1000mg in 4 capsules (with 250ml water before breakfast , each day, during 5 weeks
15862148|NCT03945149|Dietary Supplement|Placebo|30 subjects will take 4 capsules with 250ml water before breakfast , each day, during 5 weeks
15862149|NCT03945136|Behavioral|Dynamic Interpersonal Therapy|Dynamic Interpersonal Therapy is a time-limited, manualized, interpersonal and affect-focused psychodynamic treatment that is frequently used to target depression and anxiety.
15862150|NCT03945123|Dietary Supplement|Red ginseng|Red ginseng tablet 120g
15862151|NCT03945110|Device|iAluRil® intravesical instillations|50ml of a sterile solution of sodium hyaluronate (1.6% 800mg/50ml) and sodium chondroitin sulphate (2% - 1 g/50ml) is administered intravesically (directly into the bladder) via a pre-filled syringe connected to a catheter and held in the bladder for at least 30 minutes.
15862152|NCT03945097|Behavioral|preK|Subjects enter and education program that either focuses on learning letters and their corresponding sounds or on language comprehension skills.
15862153|NCT03945084|Drug|Niraparib|"Niraparib will be administered as a flat-fixed, continuous daily dose:
~≥77 kg and ≥150,000 µL: 300 mg (3 X 100 mg capsules) daily <77 kg or <150,000 µL: 200 mg (2 X 100 mg capsules) daily*
~* For patients whose starting dose is 2 capsules once daily, escalation to 3 capsules once daily will be permitted if no treatment interruption or discontinuation will be required during the first 2 cycles of therapy"
15862154|NCT03945084|Other|Best supportive care|"In both treatment arms, Best Supportive Care (BSC) is defined as a comprehensive assessment of symptoms, with timely application of symptom control measures, in order to maximize patient's quality of life.
~BSC does not include any active antitumoral treatment, and will be given according to local guidelines and the normal practice of each participating institution.
~BSC will include use of opioid analgesics, other supportive drugs, radiotherapy, administered with the exclusive aim of improving tumor symptoms (e.g. pain, haematuria, etc.), according to Investigator's judgment."
15862155|NCT03945071|Device|Punctal plug|Punctal plug will be given to subjects after intravitreal injection in half of the study subjects
15862156|NCT03945058|Device|TVS|Active TVS will be performed by use of a Tragus stimulator device with electrodes attached to the tragus of the ear. Stimulator will be applied continuously for 1 hour daily for 4 weeks
15862157|NCT03945058|Device|SHAM|Active TVS will be performed by use of a Tragus stimulator device with electrodes attached to the earl lobule. Stimulator will be applied continuously for 1 hour daily for 4 weeks.
15862158|NCT03945045|Procedure|Subclavian vein approach|Subclavian vein approach for Ultrasound-guided Implantation of TIVAD
15862159|NCT03945045|Procedure|internal jugular vein approach|internal jugular vein approach for Ultrasound-guided Implantation of TIVAD
15862160|NCT03945032|Other|TICOP|Parent moves the cursor by analogy on their mobile phone (as a visual anagogic scale) four times per year (baseline; month 4; month 8 and month 12).
15862161|NCT03945019|Biological|CT-P13 SC (Infliximab)|Subcutaneous injection of CT-P13 SC
15862162|NCT03945019|Other|Placebo SC|Subcutaneous injection of Placebo SC
15862163|NCT03945006|Other|Incontinence Severity|The Incontinence Severity Index (ISI) was used to assess the MS patients' incontinence severity.The first item is scored between 1 and 4 and the second item is scored between 1 and 3. The total score is calculated by the multiplication of these two answers. The index score is classified as 1-2 slight, 3-6 moderate, 8-9 severe, and 12 very severe.
15862164|NCT03945006|Other|Balance|The patients were assessed while their bladders were empty. The static balance of the patients was measured with a Technobody® stabilometric platform. The patients were assessed while their bladders were empty. The test was performed as the patients' arms on the sides, eyes open and closed, and on two feet. Ellipse area, anterior-posterior sway, and medial-lateral sway scores were recorded.
15862165|NCT03945006|Other|Trunk impairment|Trunk impairment was assessed with the Trunk Impairment Scale (TIS) while the participants' bladders were empty. The scale evaluates static and dynamic sitting balance and trunk coordination through 17 items. Each item is scored between 0 and 3. The total score ranges between 0 and 23, and higher scores indicate a better balance performance.
15862166|NCT03945006|Other|Fear of falling|Fear of falling was assessed using the Falls Efficacy Scale developed by Tinetti and colleagues. The scale has 10 items assessing the effect of fear of falling on the confidence level of the individuals while performing activities of daily living. Each items is scored by the participants between 0 (not at all concerned) and 10 (very concerned), and the total of the score ranges between 0 (low fall efficacy) and 100 (high fall efficacy)
15862167|NCT03944993|Device|Pulsed Electromagnetic Fields Therapy (Dominant leg)|"Participants of this arm will be exposed to 10 minutes of Pulsed Electromagnetic Fields on their dominant leg once a week for a total of 6 weeks. A minimum of 5-day and maximum of 9-day interval between each treatment session shall be followed.
~The PEMF device produces pulsed magnetic fields at flux densities up to 1.5 mT peak."
15862168|NCT03944993|Device|Pulsed Electromagnetic Fields Therapy (Non-dominant leg)|"Participants of this arm will be exposed to 10 minutes of Pulsed Electromagnetic Fields on their non-dominant leg once a week for a total of 6 weeks. A minimum of 5-day and maximum of 9-day interval between each treatment session shall be followed.
~The PEMF device produces pulsed magnetic fields at flux densities up to 1.5 mT peak."
15862169|NCT03944993|Device|Sham Therapy (Control)|Participants of this arm will be not be exposed to the fields. Sham treatment will utilise the same PEMF apparatus for 10 minutes, but in non-operational mode, which is indistinguishable from when the apparatus is in operation. Duration of intervention is 6 weeks. A minimum of 5-day and maximum of 9-day interval between each treatment session shall be followed.
15862170|NCT03944980|Drug|Docetaxel|Docetaxel injection
15862171|NCT03944980|Biological|PD1-T cells|PD1-T cells injection
15862172|NCT03944954|Drug|Marinol|Individuals will receive 0, 10, 30mg of Marinol.
15862173|NCT03944954|Device|Transcranial Magnetic Stimulation|Individuals will receive excitatory or inhibitory TMS
15862174|NCT03944941|Drug|Avelumab|Given IV
15862175|NCT03944941|Drug|Cetuximab|Given IV
15862310|NCT03943901|Drug|Prednisone|Steroid, anti-inflammatory
15862176|NCT03944928|Other|Lung ultrasound|"For each usual consultation every 3 months, the patient will have clinical examination and pulmonary function tests (CPI score). Thoracic ultrasound will be made during the consultation (M0, M3, M6, M9 and M12). The presence, gravity and localisation of each ultrasound sign will be described. CT-scan data will be collected in the 3 months before the start of the study and during the study. To be enrolled in the study does not change to the usual follow-up.
~For the thoracic ultrasound, a convex probe will be used (1 to 5 MHz). Patient will be layed down in a right lateral prone position then left. Thoracic ultrasound will be timed, saved and anonymized. 14 intercostal spaces will be explored by experimented operator.
~The records will be seen a second time by same operator then a second operator. this will measured interoperator and intraoperator variability."
15862177|NCT03944915|Drug|Carboplatin|Carboplatin will be given through IV infusions for 30-60 minutes on day 1 of each cycle. Each cycle will last 21 days. There will be 3 cycles.
15862178|NCT03944915|Drug|Paclitaxel|"During Induction Therapy Paclitaxel (100 mg) will be given through IV infusions on days 1, 8 and 15 of each 21 day cycle. There will be 3 cycles.
~During Radiotherapy, paclitaxel will be given after a dose of radiation by IV infusion for 60 minutes after day 1 of radiotherapy."
15862179|NCT03944915|Drug|Nivolumab|Nivolumab will be given through IV infusions at 360 mg on day 1 every 21 days for 3 cycles.
15862180|NCT03944915|Radiation|Radiation|Patients will receive 4.5-5 cycles of radiation depending on response. Those with a positive response will receive radiation for 4.5 cycles with a total radiation dose of 66 Gy. Patients with a moderate or no response will receive 5 cycles with a total radiation dose of 70-75 Gy. 2 times a day for days 1-5 followed by a rest period for days 6-13
15862181|NCT03944915|Drug|Hydroxyurea Pill|One dose of hydroxyurea pill by mouth at start of 5-FU infusion during radiotherapy cycle
15862182|NCT03944915|Drug|5-fluorouracil|5-FU will be given by IV infusion continuously for 5 days during radiotherapy cycles
15862183|NCT03944915|Drug|Filgrastim Injection|Filgrastim shot will be given if patient has certain side effects during radiotherapy cycle on days 6-12.
15862184|NCT03944915|Drug|Cisplatin|Radiotherapy may also be given with a different chemotherapy agent called cisplatin. This is the traditional standard of care chemotherapy regimen. In this case, the radiotherapy will be given once daily for 5 days per week. Cisplatin will be administered via IV once every 21 days for 2 or 3 cycles.
15862187|NCT03944889|Drug|Capsaicin|Capsaicin 50ug (low dose), Capsaicin 100ug(high dose) will be administered as a topical skin cream and will be intermixed with saline for the injectable solution.
15862188|NCT03944889|Device|Delsys Trigno Galileo System|This device is a wireless surface EMG device.
15862189|NCT03944889|Device|Cadwell Sierra Wave|Intramuscular EMG recording machinery
15862190|NCT03944889|Device|Sonosite Ultrasound Machine|Ultrasound System
15862191|NCT03944889|Device|Goniometer|A device to measure angular position
15862192|NCT03944876|Drug|Botulinum toxin type A|Botulinum toxin 25 Allergan units in 0.5 ml Sodium Chloride (NaCl) 0.9 % Braun. One injection in the headache side of the face, targeted at the sphenopalatine ganglion (SPG)
15862193|NCT03944876|Drug|placebo|0.5 ml Sodium Chloride (NaCl) 0.9% Braun. One injection in the headache side of the face, targeted at the sphenopalatine ganglion (SPG)
15862194|NCT03944863|Drug|Antibiotics|
15862195|NCT03944850|Behavioral|Computerized Anxiety Sensitivity Treatment|CAST is a newly developed computerized intervention designed to closely model the educational and behavioral techniques that are commonly used in the treatment of anxiety and related conditions. A psychoeducation component focuses on the nature of anxiety and its effects on the mind and body. Veterans will be taught that physiological and psychological arousal is not dangerous, although they may have developed a conditioned fear of this arousal. Interoceptive exposure (IE) exercises will also be introduced to as a way to reduce or eliminate the conditioned fear response.
15862196|NCT03944837|Other|Oxygen gas|Transient maternal oxygen administration during echocardiographic and MRI imaging
15862197|NCT03944824|Other|Exercise Plan using resistance bands|Exercise under the guidance of an exercise physiologist using elastic resistance bands and weekly meeting with an exercise physiologist for 12 weeks
15862198|NCT03944824|Diagnostic Test|Modified Fried Frailty Scale|Patients will be screened for frailty pre and post with sit-to-stand test, timed up and go test, handgrip strength test and administered the low physical activity questionnaire. These components together consist of the Modified Fried Frailty Index.
15862199|NCT03944811|Procedure|piezoelectric device|crestal approach will be used to augment the maxillary sinus with simultaneous implant placement
15862200|NCT03944811|Procedure|Summers technique|Summers technique
15862201|NCT03944798|Other|Frequency: Every 3 Months|every 3 months
15862202|NCT03944798|Other|Frequency: Every 6 Months|every 6 months
15862203|NCT03944798|Other|Imaging Modality: Chest Radiograph (CXR)|Chest radiograph (CXR)
15862204|NCT03944798|Other|Imaging Modality: Chest CT|Chest computed tomography (CT)
15862205|NCT03944785|Drug|XADAGO (safinamide)|XADAGO (safinamide) is a monoamine oxidase type B (MAO-B) inhibitor indicated as adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing off episodes.
15862206|NCT03944772|Drug|Osimertinib|Osimertinib given orally at 80 mg once daily
15862207|NCT03944772|Drug|Savolitinib|Savolitinib will be given orally at 300 mg or 600mg once daily
15862208|NCT03944772|Drug|Gefitinib|Gefitinib given orally at 250 mg once daily
15862209|NCT03944772|Drug|Necitumumab|Necitumumab given IV at 800 mg on Day 1 and Day 8 of every 3-week cycle
15862210|NCT03944772|Drug|Durvalumab|Durvalumab given IV at 1500 mg on Day 1 of every cycle
15862211|NCT03944772|Drug|Carboplatin|Carboplatin given IV on Day 1 of every 21-day cycle for up to 6 cycles
15862212|NCT03944772|Drug|Pemetrexed|Pemetrexed given IV at 500 mg/m2 body BSA on Day 1 of every cycle
15862213|NCT03944772|Drug|Alectinib|Alectinib given orally at 600mg twice daily and for Japanese patients at 300mg twice daily.
15862214|NCT03944772|Drug|Selpercatinib|Selpercatinib given orally at 160mg twice daily
15862216|NCT03944746|Other|Education Curriculum|Different educational curriculums were applied to each cohort
15862217|NCT03944733|Dietary Supplement|Iron|65 mg of iron (ferrous sulfate)
15862218|NCT03944733|Dietary Supplement|Gelatin|600 mg gelatin
15862219|NCT03944707|Drug|LOU064 100 mg|LOU064 100 mg once daily orally administered as two 50 mg capsules
15862220|NCT03944707|Drug|Placebo|Placebo once daily administered orally as capsules
15862221|NCT03944694|Diagnostic Test|Delirium assessment.|Full blood count analysis.
15862222|NCT03944681|Drug|Droperidol Injectable Solution|An electrocardiogram analysis in: 5,10,15,20 minutes after injection of 1.25 mg of droperidol used as PONV prophylaxis.
15862223|NCT03944668|Behavioral|Exercise|36 sessions of comprehensive cardiac rehabilitation over 12 weeks
15862224|NCT03944655|Drug|Strepsils Anaesthetic Formula|Oral administration of a Strepsils® Max Plus lozenge containing the active ingredients amylmetacresol 0.6 mg, 2,4-dichlorobenzyl alcohol 1.2 mg, lignocaine hydrochloride 10mg with sweeteners and flavourings.
15862225|NCT03944655|Dietary Supplement|Clear Mint Drops|Oral administration of a lozenge containing glucose syrup, sugar, and flavourings
15862226|NCT03944642|Behavioral|Breastfeeding support|Breastfeeding self-efficacy enhancing through professional support
15862227|NCT03944616|Behavioral|Diet Beverage|Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.
15862228|NCT03944616|Behavioral|Water|Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
15862229|NCT03944590|Other|patient survey|patient survey on clinical outcome after screw osteosynthesis of radial head fractures
15862230|NCT03944590|Other|analysis of radiographs|analysis of radiographs on radiological outcome after screw osteosynthesis of radial head fractures
15862231|NCT03944577|Drug|Evolocumab (Repatha)|Enrolled study participants will be treated with evolocumab (Repatha) 140 mg injected subcutaneously every 2 weeks for 52 weeks. All study participants will receive instruction on correct self-administration by research pharmacists. Study drug will be mailed to patients on a monthly basis for self-administration by patients. The evolocumab dose (140 mg every 2 weeks) will remain constant for the duration of the study. Side effects will be assessed on a quarterly basis. Serious adverse events considered related to treatment, death, and pregnancy will all result in immediate discontinuation of the study drug.
15862232|NCT03944564|Behavioral|Sitting|We propose a dynamic standing approach (working while standing accompanied by small periodic stepping movements) as a more tolerable and thereby more applicative lifestyle modification. To evaluate this form on healthy subjects, three different conditions will be applied: 4 hours of sitting, static standing and dynamic standing. Both standing conditions will be done with height-adjustable table which was developed at the University of Michigan (Ann Arbor, Michigan, USA)
15862233|NCT03944564|Behavioral|Static standing|We propose a dynamic standing approach (working while standing accompanied by small periodic stepping movements) as a more tolerable and thereby more applicative lifestyle modification. To evaluate this form on healthy subjects, three different conditions will be applied: 4 hours of sitting, static standing and dynamic standing. Both standing conditions will be done with height-adjustable table which was developed at the University of Michigan (Ann Arbor, Michigan, USA)
15862234|NCT03944564|Behavioral|Dynamic standing|We propose a dynamic standing approach (working while standing accompanied by small periodic stepping movements) as a more tolerable and thereby more applicative lifestyle modification. To evaluate this form on healthy subjects, three different conditions will be applied: 4 hours of sitting, static standing and dynamic standing. Both standing conditions will be done with height-adjustable table which was developed at the University of Michigan (Ann Arbor, Michigan, USA)
15862235|NCT03944551|Device|Bubble CPAP|Those assigned to the bCPAP group will receive a Total flow oxygen at a rate of 2 liters per kilogram to a maximum of 10 liters per minute using the appropriate nasal prongs for the age and size of the patient. The positive end-expiratory pressure (PEEP) provide by bCPAP will start at 8cm HO2. The FIO2 will be adjusted to obtain a saturation of oxygen of 90% or greater.
15862236|NCT03944551|Other|Standard Therapy|For patients in the standard therapy group, oxygen will be delivery by nasal cannula at a flow rate of 4 Liters per minute. If a patient in the standard group after 1 hour of treatment still has a SpO2 < 90% or meeting criteria of treatment failure the patient will be move from the standard therapy group to the bCPAP group.
15862237|NCT03944538|Behavioral|Lifestyle Physical Activity|The intervention consists of two primary components: a dedicated Internet website and one-on-one video chats with a behavioral coach via Zoom. The intervention focuses on the skills, techniques, resources and strategies for becoming and staying physically active with MS, but does not provide a prescription for exercise or physical activity itself.
15862238|NCT03944538|Behavioral|General Wellness|The control condition provides an Internet website and one-on-one video chats that discuss materials about self-managing MS consequences and health indicators through methods other than physical activity.
15862239|NCT03944525|Device|High flow nasal cannula|Oxygen-therapy via HFNC
15862240|NCT03944525|Device|Continuous positive airway pressure|Non-invasive CPAP ventilation
15862241|NCT03944512|Drug|Pravastatin|20 mg Pravastatin taken daily
15862242|NCT03944512|Other|Placebo|Identical appearing placebo pill
15862243|NCT03944499|Drug|FS-1502|"Dose-Escalation Phase (Phase 1a)： FS-1502 dose-escalation will be proceeded on standard 3+3 design with starting dose of 0.1 mg/kg, IV, once per 28 days, 28 days as a cycle in the V1.2 and V2.0 regimens; IV, once per 21 days, 21 days as a cycle in the V3.0 regimens..
~Dose level 1: 0.1 mg/kg; Dose level 2: 0.2 mg/kg; Dose level 3: 0.4 mg/kg; Dose level 4: 0.6 mg/kg; Dose level 5: 0.8 mg/kg; Dose level 6: 1.0 mg/kg; Dose level 7: 1.3 mg/kg. If 1.3mg/kg is still tolerated safely and in line with linear kinetic characteristics, and combined with the results of PK, PD, safety and effectiveness, a comprehensive assessment is made to determine whether to continue the dose escalating. The subsequent dose increase ratio is 33% (the dose increase ratio can be adjusted according to the previous data results) until MTD or RP2D.
~Dose-expansion Phase (Phase 1b) : RP2D determined in phase 1a, IV."
15862244|NCT03944486|Other|Feasibility of On-Track|Patients to use digital application- study assessed the feasibility of the application for patients and therapists.
15862245|NCT03944473|Drug|Sugammadex|Patients undergoing laparoscopic ambulatory surgery randomized into Sugammadex group will receive a dose of Sugammadex as their reversal agent
15862246|NCT03944473|Drug|Neostigmine|Patients undergoing laparoscopic ambulatory surgery randomized into Neostigmine group will receive a dose of Neostigmine as their reversal agent
15862247|NCT03944460|Drug|Contraloid|Oral administration of capsules, drug substance or placebo without any excipients.
15862248|NCT03944447|Drug|Cannabis, Medical|Patients will be given medical cannabis recommendations and certifications commensurate with the state law in which the encounter occurs. The variations in mechanisms between the states for recommending, registering, certifying, and developing mandated treatment plans or doses will be adhered to; however, variations in state law and cannabis programs should not cause variation in the study design because the end-result is still the same with patients being treated with medical cannabis.
15862249|NCT03944434|Drug|Ribociclib|ribociclib 600 mg/day orally
15862250|NCT03944434|Drug|Aromatase Inhibitors, non steroideal|letrozole 2.5 mg/day orally or anastrozole 1 mg/day orally
15862251|NCT03944434|Drug|LHRH agonist|Triptorelin 3,75 mg or Leuprolide 3,75 mg or goserelin 3,6 mg, as injectable.
15862252|NCT03944421|Other|Red and Processed Meat|Integration of 240 grams (raw weight) of red and processed meat into daily diet for 2 week period.
15862253|NCT03944421|Other|Quorn|Integration of 240 grams (uncooked weight) of Quorn into daily diet for 2 week period.
15862254|NCT03944408|Procedure|stent implantation|stent implantation
15862255|NCT03944395|Other|Assisted Partner Notification Services|Three options for partner Notification services; contract referral, provider referral and dual referral
15862256|NCT03944369|Other|KB109|KB109 is a novel glycan
15862257|NCT03944369|Other|No intervention|No intervention
15862258|NCT03944356|Drug|Dabrafenib and Trametinib|Dabrafenib and trametinib treatment under routine conditions according to the applying SmPC.
15862259|NCT03944343|Other|Cereal based products|The cereal products are made from common Swedish cereals.
15862260|NCT03944330|Dietary Supplement|standard hospital diet|patients were provided standard hospital diet that provided 25-30 kcal/kg/day
15862261|NCT03944317|Drug|Sulfadoxine pyrimethamine|SP 1500/75mg tablet orally once starting from 16 weeks, at least at four weekly interval until delivery.
15862262|NCT03944317|Drug|Azithromycin|A total of 1500mg Azithromycin tablets taken orally as 500mg daily for three consecutive days starting starting from 16weeks of pregnancy and to be repeated once at least after 4 weeks
15862263|NCT03944304|Drug|Paclitaxel|Paclitaxel will be administered at 80mg/m2/day every four weeks at Day 1, Day 8 and Day 15 per cycle. One cycle consists of 4 weeks (28 days).
15862264|NCT03944291|Procedure|Pudendal Nerve Block|Pudendal Nerve Block
15862265|NCT03944278|Device|Thulium Laser|Thulium laser for skin resurfacing procedures
15862266|NCT03944265|Other|Counseling|Participate in treatment decision counseling session
15862267|NCT03944265|Other|Questionnaire Administration|Ancillary studies
15862268|NCT03944265|Other|Medical Chart Review|Ancillary studies
15862269|NCT03944252|Drug|Avelumab|avelumab 10 mg/kg iv day 1; To be repeated every 2 weeks (14 days) until progression of disease, refuse or inacceptable toxicity.
15862270|NCT03944252|Drug|Cetuximab|cetuximab 500 mg/m2 plus avelumab 10 mg/kg iv day 1. To be repeated every 2 weeks (14 days) until progression of disease, refuse or inacceptable toxicity.
15862271|NCT03944239|Biological|Retinal pigment epitheliums transplantation|Subretinal transplantation of clinical human embryonic stem cell derived retinal pigment epitheliums.
15862272|NCT03944226|Dietary Supplement|Beetroot juice|The patient will follow a 5 day dietary nitrate intervention programme, taking 3 doses of 7cl (0.4 g nitrate per dose) concentrated beetroot juice (SPORT shot, James White Drinks, Suffolk, U.K.) a day.
15862273|NCT03944213|Device|intermittent theta burst stimulation (iTBS)|20 sessions of iTBS
15862274|NCT03944200|Drug|DA-1229_01(A), Sugamet SR Tab 5/1000mg®|"Period 1: Single oral administration of 1 tablet of test drug(DA-1229_01(A)) together with 150 mL of water containing 30 g sugar.
~The wash-out for fed study is 7 days. Period 2: Single oral administration of 1 tablet of reference drug(Sugamet SR Tab 5/1000mg®) together with 150 mL of water containing 30 g sugar."
15862275|NCT03944200|Drug|Sugamet SR Tab 5/1000mg®, DA-1229_01(A)|"Period 1: Single oral administration of 1 tablet of reference drug(Sugamet SR Tab 5/1000mg®) together with 150 mL of water containing 30 g sugar.
~The wash-out for fed study is 7 days. Period 2: Single oral administration of 1 tablet of test drug(DA-1229_01(A)) together with 150 mL of water containing 30 g sugar."
15862276|NCT03944187|Diagnostic Test|Transvaginal sonography|Transvaginal sonography for measurement of cervical length, fetal head circumference and fetal head to cervix angle .
15862277|NCT03944174|Procedure|Fixation of unstable pelvic fractures|Percutaneous fixation of both iliac bones through the sacrum using one screw
15862278|NCT03944161|Dietary Supplement|Oral nutrition supplement|Hypercaloric and high protein supplement
15862279|NCT03944161|Other|Nutritional advice|Advice given by the clinician
15862280|NCT03944135|Other|Web platform: Neuronup|Neuronup is a web platform designed for neuropsychological rehabilitation that is focused on functional cognitive impairments resulting from normal aging and other causes. Neuronup emerged as a scientific, viable and accessible technological initiative.
15862281|NCT03944122|Device|ultrasound|therapeutical ultrasound were applied to the patients
15862282|NCT03944109|Drug|SHR-1209|"Pharmaceutical form: lyophilized formulation
~Route of administration: subcutaneous"
15862283|NCT03944109|Drug|Placebo|"Pharmaceutical form: lyophilized formulation
~Route of administration: subcutaneous"
15862284|NCT03944096|Procedure|FMT+MTX|FMT is performed at the beginning of the study and is repeated after 4 weeks plus MTX in the same dose.
15862285|NCT03944083|Other|Treatment as usual for ADHD|Children are given treatment according to diagnostic conclusion and clinical recommendations.
15862286|NCT03944070|Drug|Ranibizumab|Intravitreal Ranibizumab is approved for the treatment of wet AMD. In this study we will compare an intensive injection protocol versus the standard treat and extend protocol in wet AMD patients undergoing cataract surgery.
15862287|NCT03944057|Drug|ATG-010|"ATG-010 (Selinexor) will be given at an oral fixed milligram (mg) dose of 80 mg twice weekly each week for four-week cycles (total of 8 ATG-010 doses per cycle).
~Dexamethasone 20 mg will be given with each dose of ATG-010 (Selinexor)"
15862288|NCT03944044|Other|Paracetamol route in palliative-care patients: intravenous versus subcutaneous route Pharmacokinetics study protocol|Compare the pharmacokinetic (PK) of SC and intravenous (IV) routes in the same patient in a palliative care situation, to determine if there is a PK equivalence between these two modes of administration of Paracetamol.
15862289|NCT03944031|Drug|LY3372689|Administered orally.
15862290|NCT03944031|Diagnostic Test|[18F]LSN3316612|Administered IV.
15862291|NCT03944018|Behavioral|Intervention with rehabilitation coordinator|Intervention with rehabilitation coordinator in orthopedic care
15862292|NCT03944005|Procedure|Spinal Anesthesia + ACB continious catheter + iPACK + Sham LIA|"ACB - On identification of adductor canal,10ml ropivacaine 0.5% with 1:400,000 epinephrine will be injected to surround the femoral artery.Following catheter placement, another 10ml of the same solution will be injected. Continuous infusion of 5ml/hr 0.2% ropivacaine will be infused till considered ready to discharge.
~Ipack - Posterior knee infiltration will be performed following ACB. On visualization of femoral condyle and popliteal artery, 20ml ropivacaine 0.5% with 1:400,000 epinephrine will be infiltrated in muscular space between popliteal artery and posterior femoral condyle.
~Spinal anesthesia will be performed following nerve blocks. All patients will receive 2-3ml of 0.75% preservative-free bupivacaine at the level of L2-3 or L3-4 intervertebral space.
~LIA - Patients in Group 1 will receive local infiltration 100ml of normal saline around the knee capsule of 100ml of normal saline by the surgeons as a Sham injection."
15862293|NCT03944005|Procedure|Spinal Anesthesia + LIA + Sham Blocks|"ACB - On identification of adductor canal, 10ml of saline as a sham solution will be injected to surround the femoral artery. Following catheter placement, another 10ml of the same solution will be injected. Continuous infusion of 5ml/hr of saline will be infused till considered ready to discharge.
~Ipack - Posterior knee infiltration will be performed following ACB. On visualization of the femoral condyle and popliteal artery, 20ml of saline will be infiltrated in the muscular space between popliteal artery and posterior femoral condyle.
~Spinal anesthesia will be performed following the nerve blocks. All patients will receive 2-3ml of 0.75% preservative-free bupivacaine injected at the level of L2-3 or L3-4 intervertebral space.
~LIA - Patients will receive local infiltration by the attending surgeon intraoperatively with 300mg of ropivacaine (100ml of 0.3% ropivacaine),30 mg of ketorolac, and 10mg of morphine around the knee capsule."
15862294|NCT03943992|Drug|YYD601 40mg|Patients should take druges 30 minutes before breakfast.
15862295|NCT03943992|Drug|Nexium 40mg|Patients should take druges 30 minutes before breakfast.
15862296|NCT03943992|Drug|Placebos|The placebo YYD601 is made from microcrystalline cellulose covered with hard shell. The placebo Nexium is made from microcrystalline cellulose, Crospovidone, Magnesiumstearat and other ingredients.
15862297|NCT03943979|Other|Cognitive Training|Cognitive Training (CT): 4 consecutive days, 30-45 min session involving 5 different tasks designed to train executive functions and attention, available at the Guttmann Neuropersonaltrainer platform (computerized cognitive training tool certified by the Spanish Agency for Medicines and Health Products as a Class I Health Product). The difficulty level of all the tasks was automatically adjusted on a trial-by-trial basis for both Active and Active Control conditions.
15862298|NCT03943979|Device|transcranial Direct-Current Stimulation (tDCS)|tDCS: 4 consecutive days, 20 min session, delivered through multichannel tDCS (Starstim, Neuroelectrics), with an excitatory target over the r-dlPFC, and an inhibitory target on the contralateral lobe (l-dlPFC). The positioning of the multichannel tCS (electrode location and currents) was solved using the Stimweaver (Ruffini 2013). The resulting tCS montage employed 8 gelled Ag/AgCl electrodes of π cm2 size (Pistim, Neuroelectrics) placed at AF3(-1093uA), AF4 (1178uA), F3 (-1161uA), F4 (1104uA), F7 (-414uA), F8 (530uA), FC5 (1189uA), FC6 (-1332uA).
15862299|NCT03943966|Diagnostic Test|18F-GP1 PET CT|PET CT scan using platelet radiotracer 18F-GP1
15862300|NCT03943953|Behavioral|Information and Therapy Guides|"We have developed seven self-guided information and therapy guides (ITGs), for people with facial palsy and/or their friends or relatives. We have written these guides by drawing on interventions with a strong evidence-base in other populations, such as cognitive behavioural therapy, social skills training and acceptance and commitment therapy:
~Facial palsy: Coping with the early stages.
~Facial palsy: Coping with comments, questions and staring.
~Facial palsy: Communicating with confidence.
~Facial palsy: Managing anxiety.
~Facial palsy: Managing your mood.
~Facial palsy: Building your self-esteem.
~Facial palsy: Advice for friends, family and partners."
15862301|NCT03943940|Biological|BM-MNC and UC-MSC|"Autologous bone marrow mononuclear cells (BM-MNCs) and allogeneic umbilical cord tissue-derived mesenchymal stem cells (UC-MSCs) under sterile conditions to treat this disease.
~UC-MSC: 1-2 x 10^6 cells/kg"
15862302|NCT03943940|Other|Control|Standard medicine
15862303|NCT03943927|Other|Guided Metoprolol Management|"CYP2D6 Genotyping: Consented patients will have blood drawn for genotyping prior to surgery. Patients will be classified as poor metabolizers, intermediate metabolizers, extensive (normal) metabolizers, or ultrafast metabolizers.
~Pharmacogenetic- Guided Metoprolol Management: A best practice advisory will be integrated into institutional clinical decision support systems for metoprolol dosing based on metabolic status of each patient."
15862304|NCT03943914|Combination Product|Preventive strategy|In the experimental strategy, NIV is performed after inclusion in patients with moderate hypoxemia, defined by a PaO2/FiO2 ratio < 300 mmHg. The minimally required duration of NIV was 4 hours per day for at least 2 calendar days. The daily duration of NIV can be increased at the discretion of the physician in patients with signs of delayed respiratory failure under HFNC-O2 and improving under NIV. Beyond the first 48 hours, NIV and HFNC-O2 can be stopped and the patient switched to COT if respiratory rate < 25/min and SpO2 > 92% under FiO2 < 30% for at least 6 hours.
15862305|NCT03943914|Combination Product|Standard of care|In the control group, patients receive oxygen from nasal cannula or high concentration oxygen mask according to the FiO2 needed to achieve SpO2 > 92%. NIV is initiated only in patients having PaO2/FiO2 ratio < 200 mmHg under COT. A trial of curative NIV is allowed at the discretion of the physician in patients who have signs of delayed respiratory failure and no other organ dysfunction. The non-improvement of respiratory conditions after 1 hour of NIV, the NIV-dependence (≥ 12 consecutive hours) or NIV-intolerance should be considered as criteria for endotracheal intubation.
15862306|NCT03943901|Drug|Rituximab|Rituximab is a monoclonal antibody
15862307|NCT03943901|Drug|Cyclophosphamide|Chemotherapy drug, alkylating agent
15862308|NCT03943901|Drug|Doxorubicin|Chemotherapy drug, anthracycline antibiotic
15862309|NCT03943901|Drug|Vincristine|Chemotherapy drug, plant alkaloid
15862312|NCT03943888|Drug|Sugammadex Injection 2mg/kg|Intravenous injection of 2mg/kg of sugammadex sodium 15 minutes after rocuronium administration
15862313|NCT03943888|Drug|Sugammadex Injection 4mg/kg|Intravenous injection of 4mg/kg of sugammadex sodium 15 minutes after rocuronium administration
15862314|NCT03943888|Drug|Sugammadex Injection 8mg/kg|Intravenous injection of 8mg/kg of sugammadex sodium 15 minutes after rocuronium administration
15862315|NCT03943888|Drug|Neuromuscular reversal agent injection|Intravenous injection of 0.02mg/kg of atropine and 0.03mg/kg of neostigmine
15862318|NCT03943862|Behavioral|2Share|"The peer-led group program contains of three lessons plus one booster session:
~Lesson 1: Consider the pros and cons of disclosing: Participants reflect on their experience of self-stigma and weigh their pros and cons of (non-)disclosing a suicide attempt.
~Lesson 2: Different ways to disclose: Participants learn about the different ways to disclose and their respective pros and cons. Afterwards participants develop strategies to choose a person to disclose to, and discuss possible responses they might experience.
~Lesson 3: Telling your story: Participants learn how to tell their own story.
~In a booster session, participants will discuss their experiences with disclosure or non-disclosure."
15862323|NCT03943836|Behavioral|Music|Patients in the music group will listen to classical music during their dental procedure.
15862324|NCT03943823|Drug|Estrogen vaginal cream|Either Premarin or Estrace cream will be used (dependent on patient's insurance). Premarin 1 gram every night for the first 7 days, then 0.5 grams twice weekly. Estrace cream 2 grams daily for first 7 days, then 1 gram twice-weekly.
15862325|NCT03943823|Drug|Trimo-San vaginal gel|Half applicator for three times a week for 1st week, then half applicator for 2 times a week.
15862326|NCT03943810|Other|No intervention|There is no intervention
15862327|NCT03943797|Biological|Cultivated oral mucosal epithelial cell transplantation|Cultivated oral mucosal epithelial cell transplantation (COMET) will be used to treat severe limbal stem cell deficiency so as to restore the integrity of corneal surface
15862328|NCT03943784|Procedure|Endoscopic Variceal Ligation|Endoscopic varices ligation was performed with a six-shooter multiband ligator (Cook Medical, Limerick, Ireland) if medium to large varices or reddish spots, regardless of the grade of the varix, were observed. Each varix was ligated 1-2 cm above the gastro-esophageal junction, with 1 or 2 rubber bands and using no more than 5 rubber bands per session.
15862329|NCT03943784|Drug|Non-Selective Beta-Blocking Agent|Patients of the Propranolol group that presented medium to large esophageal varices without contraindication to Non-Selective Beta-Blockers, received propranolol, 1 mg/Kg/day every 8 hours, titrated to reduce the basal heart rate in 25% and not exceeding 5 mg/Kg/day. Patients were evaluated monthly until this reduction in heart rate was achieved, and every three to six months thereafter.
15862330|NCT03943771|Other|Anxiety, renal anatomy and surgery questionnaires|"The day before surgery, all the patients will be visited by a member of the investigator team for preoperative consultation and will be given a questionnaire evaluating their anxiety based on STAI and VAS scores. The two experimental groups will be offered their renal modelization to be manipulated (virtually or physically) before the questionnaire.
~A second survey assessing basic renal anatomy and surgery understanding will also be completed by the patients.
~Anxiolytics prescription prior to surgery will be collected inside the medical file."
15862331|NCT03943758|Dietary Supplement|Prepackaged Low-residue diet|Subjects in the prepackaged Low-residue diet group were given three packages of the prepackaged Low-residue diet, and instructed to ingest one package per meal without any other food being allowed in the day prior to colonoscopy.
15862332|NCT03943758|Dietary Supplement|Self-prepared Low-residue diet|Subjects in the self-prepared Low-residue diet group were instructed to follow and prepare an Low-residue diet in the day prior to colonoscopy.
15862333|NCT03943732|Diagnostic Test|FilmArray Pneumonia|FilmArray Pneumonia testing of tracheal sample
15862334|NCT03943719|Diagnostic Test|FilmArray blood culture identification panel|FilmArray blood culture identification panel is performed 24 hours on 24hours and 7 days a week on positive blood cultures to accelerate pathogens detection
15862337|NCT03943680|Device|PRGF|After tooth extraction, the socket will be grafted with PRGF-Endoret
15862338|NCT03943680|Device|ABB|After tooth extraction, the socket will be grafted with Geistlich Bio-Oss® Collagen
15862339|NCT03943667|Drug|Gemcitabine|1000 mg/m² in IV infusion over 30-40 minutes at Day 1, 8 and 15 followed by one week of rest.
15862857|NCT03939481|Other|Questionnaire Administration|Patient and physician reported responses
15862340|NCT03943667|Drug|Paclitaxel|80 mg/m² in IV infusion over 60 minutes at Day 1, 8 and 15 followed by 1 week of rest.
15862341|NCT03943654|Other|MotoMeds Healthline- illness assessment and treatment recommendation for non-emergent cases by telephone|The healthline uses a series of questions (based off of the WHO Integrated Management of Childhood Illness guidelines) asked to the parent of a sick child over the phone to remotely triage and assess the child's illness and then provide a treatment recommendation. MotoMeds is the accompanying motorcycle delivery service for basic medication delivery at nighttime.
15862342|NCT03943641|Other|This is not an intervention study|This study is based on retrospective analysis of linked routinely-collected healthcare data
15862343|NCT03943628|Behavioral|Familias Unidas|
15862344|NCT03943615|Drug|Voxelotor|
15862345|NCT03943602|Drug|Cabozantinib|Cabozantinib 60 mg/day orally
15862346|NCT03943589|Drug|Imlifidase|All subjects will receive imlifidase (Day 1) prior to standard care IVIg
15862347|NCT03943576|Drug|GXCPC1|The dose regimen is one single intra-articular injection of GXCPC1 containing 6.7×10^6 or 4×10^7 ADSCs in 3 mL saline. (allogeneic injection)
15862348|NCT03943576|Device|HA|Hya Joint Plus synovial fluid supplement 3mL
15862349|NCT03943563|Diagnostic Test|Dixon sequences acquisition|Dixon sequences acquisition
15862352|NCT03943537|Drug|Intranasal Insulin|40 units Novolin R administered intranasally using ViaNase device.
15862353|NCT03943524|Device|Interax-AI|Interax-AI is a drug interactions detection module for the electronic clinical history software DrApp
15862359|NCT03943485|Device|The uterine manipulator which is primarily used in laparoscopic hysterectomy to accurately locate the colpotomy site. We adopted this device in abdominal hysterectomy.|The uterine manipulator is primarily used in laparoscopic hysterectomy to accurately locate the colpotomy site. We hypothesized that adoption of a uterine manipulator would help the surgeon to better identify the colpotomy site by moving the uterus cranially and thus providing better visualization of the colpotomy site.
15862360|NCT03943472|Biological|Anti-BCMA CAR-T cells|Retroviral vector-transduced autologous T cells to express anti-BCMA CAR
15862361|NCT03943472|Drug|Fludarabine|30mg/m2/d
15862362|NCT03943472|Drug|Cyclophosphamide|300mg/m2/d
15862363|NCT03943472|Drug|Immune inhibitors|Immune inhibitors
15862364|NCT03943459|Drug|Quercetin|Quercetin 250 mg BID
15862365|NCT03943446|Drug|TAK-018|TAK-018 immediate-release tablets.
15862366|NCT03943446|Drug|TAK-018 Placebo|TAK-018 placebo-matching tablets.
15862367|NCT03943433|Procedure|FiO2_1.0|Alveolar recruitment is performed with 100% oxygen concentration after general anesthesia induction, after position change to Trendelenburg, after position change to supine, and at the end of operation.
15862368|NCT03943433|Procedure|FiO2_0.4|Alveolar recruitment is performed with 40% oxygen concentration after general anesthesia induction, after position change to Trendelenburg, after position change to supine, and at the end of operation.
15862369|NCT03943407|Drug|Zyclara 3.75 % Topical Cream|The cream will be applied on 4x4 cm squared areas on the volar forearm. The cream will be left in place for 2h, 1 h or 30 min (sub-study 1) after which it will be removed. The technical and security procedures will be conducted in accordance with the manufacturer's instructions.
15862370|NCT03943407|Drug|Prudoxin|The anti-histamine cream Prudoxin, containing 5% doxepin hydrochloride (1 g contains 50 mg of doxepin) (Healthpoint, San Antonio, TX) will be applied on the volar forearm. Two adhesive patches 4×4 cm (1mm thick, 3M foam adhesive tape, 3M, St. Paul, MN) each with a 3.5×3.5 cm center cut out (to deposit 1.2 grams of cream) will be each placed 3 cm distal and 3 cm proximal to the center of the volar aspect of each arm. Each patch will be covered with Tegaderm I.V., an occlusive, adhesive dressing (3M), for at least 1 h and 30 minutes.
15862371|NCT03943407|Other|Histamine|To deliver histamine, standard allergy skin prick test (SPT) lancets are applied. The lancets have a 1 mm shouldered tip adapt to introduce a small amount of test substance extremely locally and approximately at the dermo-epidermal junction. . A small drop of histamine dihydrochloride (1%, in saline) will be applied to a previously determined area on the volar forearm followed by a prick through the drop.
15862372|NCT03943407|Other|Cowhage|Cowhage spicules are 1-2 mm in length and have diameter of 1-3 um at their tip. The active substance delivered (mucunain) has been calculated to be in the nanogram range. The insertion of cowhage spicule(s) rapidly and consistently produces itch with no or very little flare reaction. This insertion is conducted by forceps using a stereo-microscope, and 30-35 spicules are gently rubbed into a 1 cm diameter skin area.
15862373|NCT03943407|Other|L-menthol|L-menthol (≥99.9%, TRPM8 agonist; (Sigma Aldrich, Broendby, Denmark) is dissolved in 96% ethanol at concentrations of 40%(w/v) L-menthol. A 1 mL aliquot is dispensed onto a 3 × 3 cm cotton pad and placed on a 6 × 6 cm sheet of medical tape. In between the cotton pad and the medical tape, a layer of parafilm will be added to avoid evaporation. This configuration was subsequently applied for 1 h.
15862374|NCT03943407|Other|Trans-cinnamaldehyde (CA)|CA will be obtained from Sigma Aldrich (Brøndby, Denmark) and dissolved in 90% ethanol at a concentration of 10% (vol/vol) CA. One ml aliquot of CA is dispensed onto a 3x3 cm cotton pad and placed on a 5x5 cm sheet of medical tape. Between the cotton pad and the tape, a layer of plastic film will be added to inhibit the evaporation of the solutions. This configuration will be applied for 1 h.
15862414|NCT03943069|Procedure|Thoracoscopic bullectomy with pleurodesis|Thoracoscopic stapling of emphysematous like changes (ELCs) to control the air leak from the lung bullae.in addition to mechanical pleurodesis.
15862415|NCT03943056|Drug|BIIB091|Administered as specified in the treatment arm.
15862416|NCT03943056|Drug|Placebo|Administered as specified in the treatment arm.
15862853|NCT03939507|Other|AEP score available to the treating physician|the treating physician knew the AEP score results
15862375|NCT03943394|Other|fresh samples are obtained from patients for detction of PCM1- JAK2 fusion gene|"Samples are dehydrated in ethanol (a 50, 80 and 95% (v/v) series, exposure for 3 min to 300 µl ethanol at each concentration) prior to hybridization.
~Samples on tapes are hybridized for 15 minutes at 55?C using a moisture-sealed slide incubation chamber. Briefly, 500 µl volumes of hybridization buffer (0.7 M NaCl, 0.1 M Tris [pH 8.0], 0.1% sodium dodecyl sulfate, 10 mM EDTA, containing probe, preheated to 55 ºC) are applied to the surface of the tape and the chamber's lid is sealed, creating a moist, temperature controlled environment within the chamber.
~After 15 min, the lid is removed and samples are briefly rinsed with probe-free hybridization buffer, preheated to 55ºC.
~Hybridized cells on tapes are counterstained for 10 minutes in the dark with ~30 µl mounting medium containing 1.5 µg ml-1 4',6-diamidino-2-phenylindole (DAPI).
~Then tapes are mounted with a coverslip and examined using a fluorescence microscope."
15862376|NCT03943381|Device|Duplex US|Duplex US (Caliper, wave forms...)in evaluation of Pelvic Veins (namely left ovarian vein). in pelvic congestion syndrome
15862377|NCT03943368|Device|Ceevra Reveal|VR models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source CT/MR image.
15862378|NCT03943355|Other|Patient before cohort (2005-2010)|The NOM protocol with AE was recognized and accepted after our previous study reported in 2004.
15862379|NCT03943355|Other|Patient after cohort (2011-2016)|The protocol of NOM became more aggressively and strictly adhered to since 2011.
15862380|NCT03943342|Drug|Ibrutinib|Given PO
15862381|NCT03943342|Drug|Venetoclax|Given PO
15862382|NCT03943329|Procedure|Standard of Care|"Will receive the standard of care free-hand technique of distal screw placement, as treated by Dr. Egol or Dr. Tejwani."
15862383|NCT03943329|Procedure|Distal targeting device technique of distal screw placement|The second group will be the interventional group which will use the distal targeting device technique of distal screw placement and will be treated by Dr. Konda and Dr. Leucht. All relevant data to the study will be collected intra-operatively.
15862386|NCT03943290|Drug|ACE-083|Recombinant fusion protein
15862387|NCT03943277|Other|No intervention, observational study|No intervention observational study
15862388|NCT03943264|Drug|XPro1595|XPro1595 will be delivered by subcutaneous injection once a week
15862389|NCT03943251|Drug|HEC113995PA•H2O tablet|2.5-、5-、10-、20-、40-、60-、80mg HEC113995PA•H2O tablet in day1.
15862390|NCT03943251|Drug|Placebo tablet|2.5-、5-、10-、20-、40-、60-、80mg Placebo tablet in day1.
15862391|NCT03943238|Biological|Infusion of Donor Hematopoetic Stem Cells and Recipient Tregs|Living donor kidney transplant recipients will receive after a preparatory regimen of total lymphoid irradiation and and anti-thymocyte globulin an infusion of purified donor CD34+ of >10 x10^6 cells /Kg, 100 x 10^6 donor T cell/ Kg and and an escalated dose of recipient Tregs starting at 25 x10^6/Kg.
15862392|NCT03943212|Other|Blood Flow Rate Reduction|Hemodialysis blood flow rate will be reduced by 100 mL/min, or to a minimum of 300 mL/min, whichever is higher. Patients will be surveyed regarding their dialysis recovery time and other symptoms weekly.
15862393|NCT03943212|Other|Control|No changes will be made to the dialysis prescription. Patients will be surveyed regarding their dialysis recovery time and other symptoms weekly.
15862394|NCT03943199|Diagnostic Test|Visual Analogue Scale for pain|Will be assessed at 0´, 30´, 60´, 90 minutes and 18 hours after the application of the analgesic.
15862395|NCT03943186|Device|Ectoin Lozenges Honey Lemon|application of Ectoin Lozenges (EHT02) in accordance with the instructions for use
15862396|NCT03943186|Device|Hyaluronic Acid/Icelandic moss Lozenges|application of the lozenges in accordance with the instructions for use
15862397|NCT03943173|Drug|Chemotherapy|Given standard chemotherapy
15862398|NCT03943173|Drug|Olaparib|Given PO
15862399|NCT03943173|Procedure|Therapeutic Conventional Surgery|Undergo surgery
15862400|NCT03943160|Device|Diamondback 360 Extended Length Orbital Atherectomy System|All patients undergoing peripheral vascular intervention (PVI) via transradial access (TRA) and for whom TRA has been successfully achieved and peripheral lesion deemed appropriate for treatment via TRA per physician discretion.
15862401|NCT03943147|Drug|BMS-986165|Specified dose on specified days
15862402|NCT03943147|Drug|Placebo|Specified dose on specified days
15862403|NCT03943134|Other|Minimally Processed Human Umbilical Cord Membrane|Implantation of minimally processed human umbilical cord membrane at the time of surgery
15862404|NCT03943134|Other|Standard Surgical Procedures|Standard surgical intervention for at least one targeted acute upper extremity trauma
15862405|NCT03943121|Procedure|Steroid-eluting stent implant|After endoscopic bilateral sinus surgery, the Steroid-eluting stents were randomly implanted in one side of the sinus.
15862406|NCT03943121|Procedure|Without Steroid-eluting stent implant|After endoscopic bilateral sinus surgery, the Steroid-eluting stents were randomly implanted in one side of the sinus. And the side without the stent is defined as the control side.
15862407|NCT03943108|Diagnostic Test|Gait analysis|Gait recorded using a sensor on the 4th vertebrae of the lumbar spine, once a week across 6 weeks during the routine PAIDOS clinic. Critical changes in walking control, stride frequency and length will be observed as individuals change speed; effectively stressing their mobility.
15862408|NCT03943095|Other|Potassium Nitrate|The test dentifrice contains 5% w/w potassium nitrate.
15862409|NCT03943095|Other|Stannous Fluoride|The test and control dentifrices contain 0.454% w/w stannous fluoride (1100 ppm fluoride).
15862410|NCT03943082|Behavioral|Cancer Educational Materials|Receive FRP brochure
15862411|NCT03943082|Other|Follow-Up Care|Receive follow-up phone call
15862412|NCT03943082|Behavioral|Questionnaire|Ancillary studies
15862413|NCT03943069|Procedure|Thoracoscopic bullectomy alone|Thoracoscopic stapling of emphysematous like changes (ELCs) to control the air leak from the lung bullae.
15862417|NCT03943043|Drug|nab-paclitaxel|"Phase I dosing regimens:
~The dose of treatment will be assigned at the time of enrolment in one of these 3 subsequent dose-levels:
~- 1° level: gemcitabine 800 mg/m2 + oxaliplatin 80 mg/m2 + nab-paclitaxel 80 mg/m2 0° level: gemcitabine 1000 mg/m2 + oxaliplatin 80 mg/m2 + nab-paclitaxel 100 mg/m2
~level: gemcitabine 1000 mg/m2 + oxaliplatin 80 mg/m2 + nab-paclitaxel 125 mg/m2
~level: gemcitabine 1000 mg/m2 + oxaliplatin 80 mg/m2 + nab-paclitaxel 150 mg/m2 each administered on day 1, every 14 day
~Phase II:
~Gemcitabine plus oxaliplatin plus nab-paclitaxel according to RP2D."
15862418|NCT03943030|Other|Pulmonary rehabilitation|The PR program will consist of supervised physical exercise sessions, which will be held 3 times a week for 8 weeks, and weekly educational sessions. Exercise sessions include aerobic exercise (30 min to 45 min) and lower limb and upper limb strength training, as well as warm-up and muscle stretching exercises after exercise. The exercise load will be individualized and determined from the patients' baseline tests, being increased progressively throughout the sessions. A baseline evaluation will be performed, which will be repeated after 9 weeks, including: clinical and laboratory parameters, endothelial function (FMD) and brachial ankle index (ABI) and exercise tests. Outcomes usually used in the assistance to evaluate PR will also be measured.
15862419|NCT03943017|Other|Inspection and safety evaluation by 3 longstanding experience physicians of early clinical researches|Adjudicate each ARC's observations according to the 3 physicians perceived medical importance regarding safety; first, adjudications are performed separately. Then disagreements are settled during a final adjudication meeting between them.
15862420|NCT03943004|Drug|DFP-14927|DFP-14927 is a large 4-arm-PEGylated-DFP-10917 molecule. DFP-10917 is a nucleoside analog similar to deoxycytidine.
15862421|NCT03942991|Drug|articaine|infiltration injection of 4%artpharmadent
15862422|NCT03942991|Drug|Mepivacaine 2% Injection|infiltration injection of 2% Mepecaine-L
15862423|NCT03942978|Other|Longitudinal Equity Action Plan|Patients admitted to general medicine pod randomized to intervention will receive a Longitudinal Equity Action Plan (LEAP), which will include a program manager to ensure they are on appropriate medical therapy, that cardiology is consulted when appropriate, that patient is set up with appropriate follow-up appointment with cardiology, that transportation is set up for follow-up visits, and a post-discharge follow up call to remind patients of the appointment and identify any post-discharge issues. This is in addition to standard of care, and there will not be any drug or device interventions.
15862424|NCT03942965|Device|Double balloon accessory device|Double balloon accessory device is used during the endoscopic polypectomy procedure
15862425|NCT03942939|Other|Primary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet time|Primary Robotic-Assisted Total Knee Arthroplasty with a short tourniquet time. Short tourniquet time is defined in this study as the release of the tourniquet after the initial exposure, resulting in a total tourniquet time of only 10-15 minutes.
15862426|NCT03942939|Other|Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet|Primary Robotic-Assisted Total Knee Arthroplasty with the use of a tourniquet
15862427|NCT03942926|Drug|Sirolimus|Patients will receive sirolimus for 6 months.
15862428|NCT03942913|Other|an observational study|this study is to describe the initial anti-thrombotic treatment strategy prescribed to the AF patient population undergoing PCI by using drug class description.
15862429|NCT03942900|Other|Additional biological samples|"Biomonitoring blood sample will be collected: 6 EDTA tubes (6 mL) for PBMC (peripheral blood mononucleated cell), 1 EDTA tube (6 mL) for plasma freezing and 2 EDTA tubes (4 mL) for ctDNA:
~at baseline,
~at first tumor assessment (phase 2 in OPTIMANAL study),
~at second tumor assessment (phase 4 in OPTIMANAL study),
~at end-point visit.
~A tumor biopsy or archived tumor sample will be mandatory at baseline."
15862430|NCT03942887|Drug|Rituximab|Patients will be intravenously treated with Rituximab 1000mg (or biosimilar) in the first week and receive a 2nd dosage of 1000mg 14 days later. Before every infusion of Rituximab patients will receive intravenous methylprednisolone 100mg together with oral acetaminophen 1000 mg and and intravenous Tavegil 2 mg. At any time during the study, a rituximab biosimilar is allowed as a substitute for the bio-originator rituximab.
15862431|NCT03942887|Drug|endoxan|Patients will be intravenously treated with a total of 6 infusions of cyclophosphamide 500mg every 2 weeks. Before every infusion of cyclophosphamide patients will receive intravenous granisetron to prevent nausea.
15862432|NCT03942887|Drug|Methylprednisolone|Patients are given 1-3 pulses of 500mg methylprednisolone i.v. up to a maximum cumulative dose of 3000mg, taking into account any doses of intravenous methylprednisolone administered within 12 weeks prior to screening.
15862433|NCT03942887|Drug|Prednisolone|after intravenous pulse methylprednisolone, oral prednisolone will be given at a dose of 1mg/kg daily and tapered according to the recommendations
15862434|NCT03942874|Behavioral|Group Reward Retraining|Adapted behavioral activation group treatment for binge eating with values and cognitive skills integrated
15862435|NCT03942861|Drug|Solu-Medrol|Standard treatment according to Danish Guidelines for acute severe ulcerative colitis.
15862436|NCT03942848|Drug|zicotinide followed by placebo|The experimental treatment period consists of Ziconotide solution that will be prepared by each local pharmacy team, in 5 or 10 milliliter (ml) vials with constant concentration of 10micrograms/mL
15862437|NCT03942848|Drug|Placebo followed by zicotinide|The placebo treatment period consists in standard saline solution (preservative-free sodium chloride 9 milligram/milliliter (mg/ml) (0.9%) solution) which will be presented exactly in vials as presented for the treatment (volume, color, shape et size of the vial). Treating physicians will not be aware of the actual contents of the pump and will increase the volume of injected placebo as a treatment solution (as Ziconotide 10 micrograms/milliliter (μg/ml). The magnitude of increase is the decision of the treating physician (as long as it remains with the recommended limits by the Hospital Anxiety and Depression Scale (HAS) but most likely augmentations will be at maximum 1 microgram per month and maximum achieved doses allowed in SPIDOL study is 20 micrograms/day (in literature approximately 75% of patients who respond satisfactorily to treatment required a dose of ≤ 9.6 micrograms/day
15862438|NCT03942835|Other|experience 1 : Competitive attention test in healthy participants|Comparison of behavioral measures (reaction times and percentage of correct responses) obtained twice with the CAT test in healthy participants (2 to 6 weeks apart).
15862439|NCT03942835|Other|experience 2 : Competitive attention test in patients with ADHD with no treatment|Behavioral (reaction times and percentage of correct responses) and Electroencephalography (EEG) measures obtained with the CAT test in patients with ADHD with no treatment.
15862440|NCT03942835|Other|experience 3 :Competitive attention test in patients with ADHD with psychostimulant treatment|Behavioral (reaction times and percentage of correct responses) and EEG measures obtained with the CAT test in patients with ADHD before and after psychostimulant treatment.
15862441|NCT03942822|Dietary Supplement|Milled chia seeds|8 weeks of an isocaloric diet supplemented with 25 g/day of milled chia
15862442|NCT03942809|Device|Effectiveness|Effectiveness and Practicability in anesthetized patient under controlled conditions
15862443|NCT03942796|Drug|lyrica, vronogabic (pregabalin)|Patients would receive oral pregabalin is initiated at a dose of 75 mg twice daily and titrated up to 600 mg as tolerated by the patient at 1,2,3 weeks
15862444|NCT03942796|Procedure|pulsed radiofrequency ablation of the dorsal root ganglion under fluroscopic guidance/ radiofrequency neurolysis/ radiofrequency denervation device name: Neuro Therm TM 1100|Patients would receive pulsed radiofrequency ablation of dorsal root ganglion using the following settings: 2-Hz frequency, 20-ms pulses in a 1 second cycle, 120 second duration and 42°C temperature. Impedance ranges between 150 and 400 Ohms at all levels under fluroscopic guidance. For each pulsed RF application, the procedure will be repeated 4 times, for a total duration of 8 minutes
15862445|NCT03942783|Other|WORKWELL|Individualised, tailored work advice and work/vocational rehabilitation, including self-management and job modifications.
15862446|NCT03942783|Other|Control|Published arthritis work booklets;written guidance on work problem identification; potential actions
15862447|NCT03942770|Behavioral|Contingency Management|Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions and verified abstinence from alcohol.
15862448|NCT03942770|Behavioral|Contingency management|Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions only with no contingency on alcohol use.
15862449|NCT03942757|Other|bilirubin serum level determination|bilirubin serum level before and after phototherapy treatment will be measured
15862450|NCT03942757|Other|Phototherapy|Preterm infant < 35 weeks of gestation with a jaundice requiring phototherapy according to NICE guidelines can be included for the duration of the phototherapy treatment.
15862451|NCT03942744|Device|on-line hemodiafiltration|on-line postdilutional hemodiafiltration with high convective transport above 21 liters
15862452|NCT03942731|Other|Behavioral allergy testing protocol|skin tests followed by drug provocation test and skin retesting between 6 weeks and 6 months
15862453|NCT03942718|Other|Exercise|Participants will obtain an individualized exercise program based on entrance examination on treadmill.
15862454|NCT03942692|Other|Phone call questionnaire|"Questionnaire for parents of subject about :
~the frequency of consultations with an allergist
~the information of the general practitioner or pediatrician
~the prescription of epinephrin auto-injector
~the frequency of renewal of epinephrin auto-injector
~the specialty of doctor who prescribed the renewal
~the implementation of specific measures in schools
~the frequency of renewal of specific measures in schools
~the number of recurrence of anaphylactic reaction
~the use of medical advice in case of recurrence of anaphylactic reaction"
15862455|NCT03942679|Other|PRP|Patients in this group will receive three ultrasound guided PRP injections in the supraspinatus tendon with one week interval (Ilhanli et al., 2015). After the injection, patients will be instructed to limit the use of shoulder for at least 24 hours and to use cold therapy for pain. After the third injection, ROM, and stretching exercises will be allowed and one month after the end of injections, patients will be recommended to begin the strengthening program as tolerated. Exercise is performed with 10 repeats five sessions per week.
15862456|NCT03942679|Other|physiotherapy|Patients in this group will be treated with hot pack for 15 minutes, ultrasound in continuous mode (1.5 watt/cm2 for five minutes), trans-cutaneous electrical nerve stimulation in brief-intense mode for 15 minutes, range of motion (ROM), followed by stretching and strengthening exercises with 10 repeats 15 sessions (five sessions per week for three weeks). After the physical therapy, the exercise program will be continued as homework during the follow-up period.
15862457|NCT03942666|Drug|Treatment A|tablet of CHF 6532
15862458|NCT03942666|Drug|Treatment B|tablet of CHF 6532
15862459|NCT03942666|Drug|Treatment C|tablet of CHF 6532
15862460|NCT03942666|Drug|Treatment D|tablet of CHF 6532
15862461|NCT03942666|Drug|Treatment E|Placebo tablet of CHF 6532
15862462|NCT03942666|Drug|Treatment F|tablet of CHF 6532
15862465|NCT03942640|Other|subctaneous perineural injection|"Buffered glucose preparation :
~2.4 ml of Na Bicarbonate 8.4% are mixed with 500ml dextrose 5%. Patients received 8 weekly injection"
15862466|NCT03942640|Other|deep prolotherapy|The injection fluid contain 1 ml of 255 glucose and 1ml of lidocaine
15862469|NCT03942614|Behavioral|Nordic pole walking|
15862470|NCT03942601|Drug|Temsirolimus|Temsirolimus Injection (0.4 mg/mL) and 20% contrast in Group 1
15862471|NCT03942601|Drug|Temsirolimus and dexamethasone sodium phosphate|Temsirolimus Injection (0.4 mg/mL), Dexamethasone Sodium Phosphate Injection, USP (3.2 mg/mL) and 20% contrast in Group 2
15862472|NCT03942588|Behavioral|High-intensity interval training|
15862473|NCT03942575|Device|Negative pressure wound therapy|Wound dressing with negative pressure on closed incisions
15862474|NCT03942549|Device|Retropubic midurethral sling|Midurethral sling
15862543|NCT03942003|Procedure|PEC blocks|PEC I-II blocks was performed
15862544|NCT03942003|Procedure|Control groups|Infiltration analgesia was performed
15862545|NCT03941990|Drug|Fixed 50:50 mixture of nitrous oxide and oxygen|Gaz inhalation will start 5 minutes before the puncture and will be continued until the end of the procedure.
15862475|NCT03942536|Other|Focus Group Discussion|At 12-month follow-up, a purposeful, convenience sample of study participants and their significant others, Community Health Workers trained as Health Navigators, and local program staff, will be invited by research staff to participate in focus group discussions to collect qualitative data on pregnancy care, experience of navigating obstetrical emergencies, financial hardships, and Health Navigation program feasibility/acceptability. Particular attention will be paid to recruiting study subjects involved in complex obstetrical emergencies, cases that involved significant delays in transfer of care, cases resulting in significant morbidity/mortality, as well as cases that involved efficient/successful care coordination, referral, and transportation.
15862476|NCT03942523|Behavioral|Behavior Change Communication to promote hygiene behavior|"Behavior Change Communication sessions will be used to promote knowledge and practices among young children and to prevent communicable diseases.
~This will include, capacity building of teachers and students, health awareness sessions at the school and improving school physical environment"
15862477|NCT03942510|Other|eccentric exercise with blood flow restriction|High/low intensity eccentric training group (80% and 40% of isometric peak torque) with or not blood flow restriction.
15862478|NCT03942484|Device|rPMS device|Pelvic floor muscle contractions will be induced by the device.
15862479|NCT03942471|Behavioral|Mindfulness Based Stress Reduction|Mindfulness-Based Stress Reduction (MBSR) is a well-defined and systematic patient-centered educational approach which provides training in mindfulness meditation to teach adolescents with Type 1 diabetes to take better care of themselves and live healthier and more adaptive lives by learning to become more connected to the present moment through the use of breath and training for awareness of the moment.
15862480|NCT03942458|Drug|Vicagrel 6mg|Vicagrel 24mg loading followed by 6mg/day for 6 days
15862481|NCT03942458|Drug|Clopidogrel 75mg|Clopidogrel 300mg loading followed by 75mg/day for 6 days
15862482|NCT03942445|Procedure|Gastrocnemius muscle biopsy|In all groups, a 5 mm large gastrocnemius muscle biopsy will be performed and the samples immediately managed in experimental laboratory.
15862483|NCT03942432|Other|Oral Glucose Tolerance Test (OGTT)|Blood samples at T0, T30min, T120min
15862484|NCT03942432|Other|Clinical exam|weight, length, waist measurement, cardiac frequency, blood pressure
15862485|NCT03942432|Biological|Blood sample|Iron and cardiac markers Serum iron, serum transferrin, transferrin saturation, serum ferritin, AST, ALT, GGT, ALP, PT, Cell Blood Count, ceruloplasminemia , hyaluronic acid, cholesterolemia, HDL, LDL, triglyceridemia, hba1c
15862486|NCT03942432|Device|MRI|3 Tesla abdominal MRI
15862487|NCT03942432|Device|Bioimpedance|Measurement of body composition
15862488|NCT03942432|Behavioral|Questionnaires|Quality of life, physical activity, alcohol consumption and eating habits
15862489|NCT03942419|Drug|Atropine 0.1% Ophthalmic Solution|Atropine 0.1% ophthalmic solution administered with a microdose dispenser
15862490|NCT03942419|Drug|Atropine 0.01% Ophthalmic Solution|Atropine 0.01% ophthalmic solution administered with a microdose dispenser
15862491|NCT03942419|Drug|Placebo Ophthalmic Solution|Placebo ophthalmic solution administered with a microdose dispenser
15862492|NCT03942406|Combination Product|BPZE1 pertussis vaccine and VaxINator(TM) Atomization Device|Live attenuated pertussis vaccine administered via the VaxINator(TM) atomization device
15862493|NCT03942380|Diagnostic Test|Liquid biopsy|The intervention is a liquid biopsy as a blood sample taken in a peripheral vein. The blood samples are analyzed for cell free DNA, RNA and HPV-DNA
15862494|NCT03942367|Device|Active Device (vPatch)|Electrical stimulation inducing motor response at the pelvic-floor muscles. Stimulation will be delivered by vPatch device configured to motor intensity.
15862495|NCT03942367|Device|Sham Device (vPatch)|Electrical stimulation inducing sensory response at the perineum.Stimulation will be delivered by vPatch device configured to sensory intensity.
15862496|NCT03942354|Drug|Bedaquiline|Bedaquiline is a diarylquinoline class antimicrobial which blocks the proton pump for ATP synthase of mycobacteria. This in turn blocks the ATP production required for cellular energy production and leading to cell death.
15862497|NCT03942354|Drug|Pretomanid|Pretomanid is a nitroimidazole class antimicrobial which interferes with cell wall biosynthesis in mycobacteria. It may have other mechanisms of action as well in non-replicating mycobacteria.
15862498|NCT03942354|Drug|Moxifloxacin|Moxifloxacin is an 8-methoxyquinolone class antimicrobial that is a potent inhibitor of DNA gyrase and topoisomerase IV in bacteria
15862499|NCT03942354|Drug|Linezolid|Linezolid, an oxazolidinone class antimicrobial which works by inhibiting ribosomal protein synthesis. It is approved for Gram-positive bacterial infections, and is increasingly being used for drug resistant TB disease.
15862500|NCT03942354|Drug|Clofazimine|Clofazimine is a lipophilic riminophenazine licensed for treatment of leprosy. Its mechanism(s) of action remains unclear, but existing evidence suggests production of reactive oxygen species within Mycobacterium tuberculosis is one mechanism.
15862501|NCT03942354|Drug|Directly observed therapy (DOT)|Standard therapy
15862502|NCT03942328|Radiation|External Beam Radiation Therapy|Undergo high-dose EBRT
15862503|NCT03942328|Biological|Pneumococcal 13-valent Conjugate Vaccine|Given IM
15862504|NCT03942328|Biological|Therapeutic Autologous Dendritic Cells|Given IT
15862505|NCT03942315|Other|Data collection from standard follow-up after liver transplant|All patients underwent regular follow-up every 6 to 12 months after the first year post-liver transplant (LT). Complete laboratory investigations were performed at each visit. Doppler ultrasonography was performed every 1 to 3 years after LT. Computed tomography (CT) scan and/ or magnetic resonance imaging (MRI) was performed at 1, 5, 10, 15, and 20 years after LT, or when clinically indicated. All available radiological material was reviewed. Cardiac evaluation was performed regularly in patients who received transplant for cardiac failure.
15862506|NCT03942289|Other|The role of the noradrenergic system across the life span (Healthy Subjects)|A sample (n=90) of balanced distribution of healthy males and females within a continuous segment of the adult life span from 20 to 80 years old will be recruited, with approximately 7 males and 7 females subjects for each decade of age. Each participant will undergo 1) a neuropsychological examination, 2) an olfactory screening and 3) a 90 min 11C-Yohimbine positron emission tomography (PET)/magnetic resonance imaging (MRI) scan in a resting state.
15862546|NCT03941990|Other|Placebo|inhale medical air (22% O2 - 78% N2)
15862854|NCT03939494|Behavioral|Telehealth Encounter|Contact will be made with participants via Face Time or Skype.
15862507|NCT03942289|Other|The role of the noradrenergic system across the life span (Parkinson's Disease Subjects)|Three groups of Parkinson Disease (PD) patients (each of them n=15) will be studied according to the duration and stage of the disease: early stage (the same group in Task 2); mid stage (5-7 years of disease duration; Hoehn and Yahr in Off 2-3); late stage (7-10 years of disease duration; Hoehn and Yahr in Off 3-4).
15862508|NCT03942276|Other|High intensity interval training|Consists of 60 seconds sets of high-intensity exercises, characterized by heart rate> 85% of maximal heart rate (HRmax), obtained through the formula (220-age), or by the Rated Perceived Exertion between 7 and 8 on the Borg scale, which ranges from 0 to 10. Of the 60 seconds of high intensity exercise, 30 seconds will be to get up and down a 16 cm step and 30 seconds of squats, with knee flexion greater than 90º, both at the highest possible speed. The recovery between sets is light walk for 60 seconds. If the volunteers do not reach the proposed intensity zone, they will be instructed to increase the number of squats and step ascents and descents.
15862509|NCT03942276|Other|Moderate intensity continuous training|Consist of performing a 30 minute walk at 50% of reserve heart rate (HRR), calculated by (HRmax - HRmax) x% + HRmax. HRmax being obtained by means of the formula (220 - age).
15862510|NCT03942276|Other|Control|Consist of performing no exercise training.
15862511|NCT03942250|Biological|REGE pro dressing|REGE pro is a dressing of dried human amniotic membrane sterilized by gamma radiation
15862512|NCT03942237|Procedure|single-injection QLB(quadratus lumborum block)|"Inject 0.4ml/kg 0.5% ropivacaine between quadratus lumborum and psoas major muscle
~Device: The curved (C1-5) probe of Ultrasound Scanner Philips CX50 is used for scan
~Drug: single dose ropivacaine 0.4ml/kg 0.5% ropivacaine is given immediately after the correct position of needle tip is verified."
15862513|NCT03942237|Procedure|Placebo Control|"Inject 0.4ml/kg saline between quadratus lumborum and psoas major muscle
~Device: The curved (C1-5) probe of Ultrasound Scanner Philips CX50 is used for scan
~Drug: single dose 0.4ml/kg 0.9% NS is given immediately after the correct position of the needle tip is verified"
15862514|NCT03942224|Drug|Bortezomib|Given SC
15862515|NCT03942224|Biological|Daratumumab|Given IV
15862516|NCT03942224|Drug|Dexamethasone|Given IV and PO
15862517|NCT03942224|Drug|Ixazomib|Given PO
15862520|NCT03942198|Drug|Taodan Granules|Put each bag of medicine in the same amount into the same container, pour about 50 ml of warm water, stir until the particles are basically dissolved, and then add appropriate amount of boiling water to dilute.
15862521|NCT03942198|Drug|Taodan Granules Placebo|Put each bag of medicine in the same amount into the same container, pour about 50 ml of warm water, stir until the particles are basically dissolved, and then add appropriate amount of boiling water to dilute.
15862522|NCT03942185|Drug|Oral Chinese Herbal Medicine of Clearing heat and Cooling blood therapy|Oral Chinese Herbal Medicine of Clearing heat and Cooling blood therapy, warm water decoction, 1 dose/day, divided into 2 times, 180 ~ 200ml each time for 8 weeks.
15862523|NCT03942185|Drug|Oral Chinese Herbal Medicine according with syndrome differentiation therapy|Oral Chinese Herbal Medicine according with syndrome differentiation therapy, warm water decoction, 1 dose/day, divided into 2 times, 180 ~ 200ml each time for 8 weeks.
15862524|NCT03942185|Drug|Oral Chinese Herbal Medicine of Promoting blood circulation and Removing blood stasis therapy|Oral Chinese Herbal Medicine of Promoting blood circulation and Removing blood stasis therapy, warm water decoction, 1 dose/day, divided into 2 times, 180 ~ 200ml each time for 8 weeks.
15862525|NCT03942172|Device|SpotOn balance glasses|SpotOn Balance Glasses comprising of personalized visual stimuli placed on the glasses's lenses
15862526|NCT03942146|Behavioral|Information on smoking cessation|Smoking cessation is recommended 6 weeks before and after surgery
15862527|NCT03942133|Procedure|ultrasound-guided short-axis placement of catheter at the entrance of the adductor canal|Ultrasound probe is placed at the entrance of the adductor canal in short axis ，insertion of a PAJUNK Contiplex S catheter with the tip of the catheter located at the entrance of the canal
15862528|NCT03942133|Procedure|ultrasound-guided long-axis placement of catheter at the middle of the adductor canal|Ultrasound probe is placed at the middle of the adductor canal in long axis with the caphelad end of the probe aligned with the entrance of the canal. insertion of a PAJUNK Contiplex S catheter with the tip of the catheter located at the middle of the canal
15862530|NCT03942107|Procedure|Group 1: single-visit RCT|both root canal treatment and post and core restoration of the coronal part of the tooth is completed in single visit prior to postoperative pain evaluation at 24, 48 and 72-h and 7-day follow-up time
15862531|NCT03942107|Procedure|Group 2: two-visit RCT|after root canal treatment is completed, postoperative pain evaluation will be conducted in this group at 24, 48 and 72-h and 7-day follow-up time. post-core application will be completed at the seventh day after postoperative pain evaluation.
15862532|NCT03942094|Drug|Nilotinib|"Nilotinib (Tasigna ®), capsules of 150 mg
~Nilotinib 2 capsules of 150 mg, orally, twice daily"
15862533|NCT03942081|Device|Ulcer Measurement Software|Photos being taken of foot ulcers. Software estimation of foot ulcer being compared to actual measured size.
15862534|NCT03942068|Drug|albumin-bound paclitaxel|Nanoparticle albumin-bound paclitaxel (nab-paclitaxel), a microtubule inhibitor
15862535|NCT03942068|Drug|Apatinib|a novel oral antiangiogenic agent targeting vascular endothelial growth factor receptor (VEGFR2)
15862536|NCT03942055|Device|Sonosite Edge II Ultrasound|Certified by UAB Biomedical and Clinical Engineering Dept- certification #9365 Mechanism of Action: Point of Care Bedside Ultrasound
15862537|NCT03942042|Drug|Ixekizumab|Administered SC
15862538|NCT03942029|Drug|LY3154207 Capsule|Administered orally as capsule
15862539|NCT03942029|Drug|LY3154207 Tablet|Administered orally as tablet
15862540|NCT03942029|Drug|Placebo|Administered orally as tablet
15862541|NCT03942029|Drug|Fluconazole Tablet|Administered orally as tablet
15862542|NCT03942003|Procedure|rhomboid blocks|Rhomboid nerve block was performed
15862547|NCT03941977|Device|Percutaneous introduction of cannula|An 8 gauge cannula is introduced at the site of the bone marrow lesion. The introduction of the cannula is guided by fluoroscopy.
15862548|NCT03941977|Diagnostic Test|Magnetic resonance imaging|MRI scans will be performed on a 1.5 T (Signa Excite HD, GE Healthcare, Waukesha, WI, USA) and a specific knee coil (HD TRKnee 8 Ch High Resolution Knee Array) will be used.
15862549|NCT03941977|Biological|Bone Grafting|A bone substitute consisting of calcium phosphate will be injected through the cannula, previously inserted, filling the area of the bone marrow lesion. GRAFTYS HBS® (Graftys, Aix en Provence, France) will be used.
15862550|NCT03941964|Drug|venetoclax|tablet; oral
15862551|NCT03941964|Drug|azacytidine|infusion; subcutaneous or intravenous
15862552|NCT03941964|Drug|decitabine|infusion; intravenous
15862553|NCT03941951|Behavioral|Non-impositive Program for Optimizing the Use of Antimicrobials|Quasi-experimental intervention through the development of a Program for Optimizing the Use of Antimicrobials in the participating hospitals. The intervention will consist of the development of a consensus guide on the use of new antibiotics, its dissemination in Andalusian hospitals and an audit on the prescription of new antibiotics.
15862554|NCT03941938|Procedure|Cyanoacrylate reinforcement|Anastomosis Reinforcement with with nebulization of 1cc of glue on the anastomosis line
15862555|NCT03941938|Procedure|No reinforcement|Nothing applied on the anastomosis line
15862556|NCT03941925|Dietary Supplement|Prebiotic fructans|Prebiotic group receiving the prebiotic fructans in two doses during the 4-week intervention period.
15862557|NCT03941925|Dietary Supplement|Non-prebiotic maltodextrin|Placebo group receiving the non-prebiotic maltodextrin in two doses during the 4-week intervention period.
15862558|NCT03941912|Device|Erchonia EVRL|Single treatment with the Erchonia EVRL to the neck and shoulders. The treatment applies 635 nanometers (nm) red diode light and 405 nm violet diode light simultaneously.
15862559|NCT03941899|Other|Levobupivacaine in QLB II|Quadratus Lomborum Block II type will be performed by injecting levobupivacaine 0.375% 20 ml between latissimus dorsi and quadratus lomborum muscle.
15862560|NCT03941886|Other|Low-dose aspirin in women with high risk of preeclampsia|Low-dose aspirin 150-162 mg/night or 100 mg/night if body weight <40 Kg, from <15 weeks till 36 weeks or, in the event of early delivery, at the onset of labor
15862561|NCT03941873|Drug|Sitravatinib|Study participants will receive sitravatinib capsule once daily
15862562|NCT03941873|Drug|Sitravatinib plus Tislelizumab|Study participants will receive sitravatinib capsule once daily and in combination with tislelizumab IV once every 3 weeks.
15862563|NCT03941873|Drug|Sitravatinib|Study participants will receive sitravatinib capsule once daily.
15862564|NCT03941873|Drug|Sitravatinib and tislelizumab|Study participants will receive sitravatinib capsule once daily and in combination with tislelizumab IV once every 3 weeks.
15862565|NCT03941873|Drug|Sitravatinib and tislelizumab|Study participants will receive sitravatinib capsule once daily and in combination with tislelizumab IV once every 3 weeks.
15862566|NCT03941873|Drug|Sitravatinib and tislelizumab|Study participants will receive sitravatinib capsule once daily and in combination with tislelizumab IV once every 3 weeks.
15862572|NCT03941847|Other|music|listening music
15862573|NCT03941834|Drug|Rimegepant|BHV3000 (rimegepant) 75mg tablet
15862574|NCT03941834|Drug|Placebo|Placebo
15862575|NCT03941821|Drug|Glecaprevir/Pibrentasvir|Chronic hepatitis C patients will be given Glecaprevir/Pibrentasvir treatment
15862576|NCT03941808|Drug|Glisodin tablet|4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months
15862577|NCT03941808|Drug|Placebo tablet|4 pills a day (1000mg) for 3 months then 2 pills a day (500 mg) for 3 months
15862578|NCT03941795|Biological|JS001(Toripalimab Injection)|"Test Group:
~Toripalimab (240 mg, IV, Q3W) + axitinib (5 mg/tablet, one tablet, twice a day, orally); axitinib is started on the second day of administration of toripalimab until disease progression or intolerable toxicity, the investigator or subject decides to withdraw, lost to follow-up, initiation of other antineoplastic therapy, or death, with a maximum duration of toripalimab use of no more than 2 years."
15862579|NCT03941795|Drug|Axitinib 1 MG [Inlyta]|Axitinib (5 mg/tablet) one tablet, twice a day, orally until disease progression or intolerable toxicity, the investigator or subject decides to withdraw, lost to follow-up, initiation of other antineoplastic therapy, or death
15862580|NCT03941795|Other|JS001 and Axitinib|"Control Group:
~Toripalimab (240 mg, IV, Q3W) is administered on the first day until disease progression or intolerable toxicity, the investigator or subject decides to withdraw, lost to follow-up, initiation of other antineoplastic therapy, or death, with a maximum duration of no more than 2 years"
15862581|NCT03941782|Drug|Alpelisib|As a single agent, alpelisib will be administered at a starting dose of 350 mg orally once daily on a continuous dosing schedule and can be adjusted for toxicity per the recommendations in this protocol. No pretreatment will be given prior to the medication.
15862582|NCT03941769|Biological|Recombinant Interleukin-7|Given IM or SC
15862583|NCT03941756|Drug|Indocyanine Green|Given IV
15862584|NCT03941756|Procedure|Lymphangiography|Undergo lymphangiography
15862585|NCT03941756|Procedure|Lymphovenous Bypass|Undergo LVB
15862589|NCT03941730|Biological|Therapeutic Estradiol|Given PO
15862590|NCT03941717|Other|Mindfulness-Based Condition|Each script for the mindfulness-based intervention was slightly modified to fit the context of a venipuncture, and begins with instructions to take deep breaths. Both scripts aim to cultivate present moment awareness of experiences, curiosity, nonjudgement, and acceptance of experiences as they unfold. In particular, the scripts ask that the participant visualize their worries and feelings as a cloud in the sky, and probes for curious thoughts about these experiences. The temporary nature of sensations is described, and the participant is asked to keep this openness and curiosity during the venipuncture.
15862591|NCT03941717|Other|Unfocused attention Condition|Each script for the unfocused attention task instructs participants to allow their mind and thoughts to roam. The aim is to encourage the participant to continue thinking and mind wandering as they typically would.
15862594|NCT03941691|Device|Fully Absorbable VSD Occlusion System|Under echocardiography guided treatment of VSD with a novel fully degradable clolsure system
15862595|NCT03941691|Device|VSD Occluder|Under echocardiography guided treatment of VSD with commercially available occluder.
15862596|NCT03941678|Dietary Supplement|Creatine monohydrate|0.3 g/kg/day for 7 days; 0.1 g/kg/day for 63 days
15862597|NCT03941678|Dietary Supplement|Placebo|0.3 g/kg/day for 7 days; 0.1 g/kg/day for 63 days
15862598|NCT03941665|Device|Gelronate|Gel for topical use
15862599|NCT03941665|Other|Aloevera|Gel for topical use
15862600|NCT03941626|Biological|CAR-T/TCR-T cells immunotherapy|According to tumor burden and other conditions, patients will be treated with cyclophosphamide or fludarabine,then,CAR-T cells will be infused 48-72 hours later.
15862601|NCT03941613|Procedure|SEEG guided RF-TC|SEEG implantation after evaluation, record the interictal and ictal EEG, and perform RF-TC after the localization confirmation.
15862602|NCT03941613|Procedure|Anterior temporal lobectomy|classical surgical treatment for mesial temporal lobe epilepsy, including the resection of neocortex for 5.5cm in non dominant hemisphere or 4.5cm in dominant hemisphere
15862605|NCT03941587|Drug|Aflibercept + reduced fluence photodynamic therapy (RF-PDT)|Aflibercept dosage of 2mg in 0.05ml along with intravenous infusion of Verteporfin (6mg/m2)followed by laser light at a dosage of 25Joule/cm2
15862606|NCT03941587|Drug|Aflibercept + sham reduced fluence photodynamic therapy (RF-PDT)|Aflibercept dosage of 2mg in 0.05ml along with sham photodynamic therapy
15862607|NCT03941574|Drug|HLX10|HLX10 developed by our company is sterile intravenous injection, with specification of 100 mg/10 mL/bottle. The main ingredient is 10.0 mg/mL of recombinant humanized anti-PD-1 monoclonal antibody. The excipients include 0.95 mg/mL citric acid (citric acid monohydrate), 4.56 mg/mL sodium citrate (sodium citrate dihydrate), 3.0 mg/mL sodium chloride, 30.0 mg/mL mannitol and 0.20 mg/mL polysorbate 80 (tween 80), with pH of 5.5.
15862608|NCT03941561|Drug|S-1 for 9 months|S-1 for 9 months after D2 resection
15862609|NCT03941561|Drug|S-1 for 1 year|S-1 for 1 year after D2 resection
15862610|NCT03941548|Drug|CTP-543 QD Dose Regimen|24 mg once-daily (QD)
15862611|NCT03941548|Drug|CTP-543 BID Dose Regimen|12 mg twice-daily (BID)
15862612|NCT03941535|Drug|Vitamin K|Administration of intravenous Vitamin K in doses of 10mg/day, 5mg/day or 2mg/day
15862613|NCT03941522|Other|Early discharge from hospital|Patients randomized to the group 23-hour stay will be discharged on the day after their surgery if they meet the discharge criteria.
15862614|NCT03941509|Behavioral|Antimicrobial stewardship|Education, guidelines, communication tools and audit and feedback
15862615|NCT03941496|Drug|Azacitidine Injection|"In Phase Ib dose escalation stage, 24 participants will receive AZA subcutaenously once a day for 5 days as follows:
~5 mg/m^2
~15 mg/m^2
~30 mg/m^2
~50 mg/m^2
~75 mg/m^2
~Results from Phase Ib are sent to FDA/IRB for approval before proceeding to Phase IIa. 36 subjects will receive AZA treatment in total (Phase Ib/IIa). Subjects in Phase II will receive a dose that induces two of the three following:
~a decrease DNA methylation levels in genes previously identified to be persistently hyper-methylated despite successful anti-TB therapy
~an increase in TNF and IFN-γ signaling pathways
~an increase in ex vivo mycobacterial growth inhibition assay"
15862618|NCT03941457|Biological|BiCAR-NK cells (ROBO1 CAR-NK cells)|The subject will be observed for any side effects during this time and all the adverse events will be recorded.
15862619|NCT03941444|Drug|ANAVEX2-73|Liquid oral solution
15862620|NCT03941444|Drug|Placebo|Liquid oral solution
15862621|NCT03941431|Drug|Jueyin granules|Jueyin granules p.o. once a day for 8 weeks.
15862622|NCT03941431|Device|moving cupping therapy|Moving cupping therapy three times per week for 8 weeks.
15862623|NCT03941431|Device|NB-UVB therapy|NB-UVB phototherapy three times per week for 8 weeks.
15862624|NCT03941431|Drug|Jueyin placebo granules|Jueyin placebo granules p.o. once a day for 8 weeks.
15862625|NCT03941431|Device|moving cupping placebo therapy|Moving cupping placebo therapy three times per week for 8 weeks.
15862626|NCT03941431|Device|NB-UVB placebo phototherapy|NB-UVB placebo phototherapy three times per week for 8 weeks.
15862793|NCT03939923|Drug|Rocuronium|Intubation with Rocuronium 1.0-1.2 mg/kg (vitals maintained within 20% of baseline. Subjects may be re-dosed with rocuronium at 0.1-0.4 mg/kg during the procedure.
15862627|NCT03941418|Dietary Supplement|Boulardii|Patients will be administered with formulation containing 500 mg of Saccharomyces boulardii and 10 mg of Vitamin D3 once daily, as an addition to their standard therapy.
15862628|NCT03941418|Dietary Supplement|Placebo|Patients will be administered with placebo of same appearance, colour and taste once daily.
15862629|NCT03941405|Drug|Albumin treatment|one dose per day of a 40g albumin g/l gram(s)/litre for 10 days. resolution of hyponatremia, defined as an increase in serum sodium of more than 5 mEq/L with a final value > 130 mEq/L, maintained for at least 48 consecutive hours during the 10-day treatment period
15862630|NCT03941366|Procedure|Standard of care chemotherapy with the change for avoidance of extensive surgery|All treatments (chemotherapy, radiation, surgery) are standard of care; however, the timing of the procedures is altered to allow for the possibility of local excision instead of more extensive surgery.
15862631|NCT03941353|Other|Usual care|Benchmark study with retrospective patient analysis evaluating the actual care patients with a fragile hip fracture receive
15862632|NCT03941340|Drug|[14]-AST2818|Volunteer will receive a single oral dose of 80 mg /100 u Ci [14C]-AST2818 as a solution on Day 1
15862633|NCT03941327|Device|AxoGuard Nerve Cuff|A porcine collagen implant will be used to make a protective sheath around the participant's exposed spinal accessory nerve during surgery. This will be performed by physically wrapping the exposed nerve with the implant and suturing the ends together. The goal is to protect nerve from adhesions and compression in the absence of normal protective lymphatic soft tissue.
15862634|NCT03941314|Device|Supera® Peripheral Stent System|The index procedure is placing a selfexpandable stent at a femoro-popliteal location. The way the stenosis or occlusion is traversed is not part of the study. It is mandatory to prepare then the vessel with PTA (at least the size of the stent) and thereafter insert the stent. Post-PTA can be performed with same balloon, but post-PTA is not mandatory to be performed.
15862635|NCT03941314|Device|EverFlex™ Self-Expanding Peripheral Stent System|The index procedure is placing a selfexpandable stent at a femoro-popliteal location. The way the stenosis or occlusion is traversed is not part of the study. It is mandatory to prepare then the vessel with PTA (at least the size of the stent) and thereafter insert the stent. Post-PTA can be performed with same balloon, but post-PTA is not mandatory to be performed.
15862636|NCT03941301|Device|Light therapy|Participants will be exposed to bright treatment light or red light 30 minutes every day for 4 weeks.
15862637|NCT03941288|Drug|Cannabidiol|"Cannabidiol and the matching placebo solution (excipients alone) will be provided in identical 100ml amber glass bottles. At the end of the treatment period, the treatment solutions will be tapered (10% volume each day) over 10 days.
~In accordance with Food and Drug Administration guidance, prior to starting treatment and at end of 1 month treatment, we shall obtain serum transaminases (alanine and aspartate) and total bilirubin levels. These tests will also be performed if patient develops clinical signs or symptoms suggestive of hepatic dysfunction (e.g., unexplained nausea, vomiting, right upper quadrant abdominal pain, fatigue, anorexia, or jaundice and/or dark urine); if such features develop the treatment will be interrupted or discontinued."
15862638|NCT03941288|Other|placebo|"Cannabidiol and the matching placebo solution (excipients alone) will be provided in identical 100ml amber glass bottles. At the end of the treatment period, the treatment solutions will be tapered (10% volume each day) over 10 days.
~In accordance with Food and Drug Administration guidance, prior to starting treatment and at end of 1 month treatment, we shall obtain serum transaminases (alanine and aspartate) and total bilirubin levels. These tests will also be performed if patient develops clinical signs or symptoms suggestive of hepatic dysfunction (e.g., unexplained nausea, vomiting, right upper quadrant abdominal pain, fatigue, anorexia, or jaundice and/or dark urine); if such features develop the treatment will be interrupted or discontinued."
15862639|NCT03941275|Diagnostic Test|Bi-plane fluoroscopy|In vivo acquisition of biplane cine radiographic images of the market released Medtronic SelectSecure 3830 pacing lead
15862640|NCT03941262|Biological|SNK01|Patient-specific ex vivo expanded autologous natural killer cells
15862641|NCT03941262|Drug|Avelumab|Avelumab is a humanized monoclonal antibody immune checkpoint blockade immunotherapy that targets the programmed cell death-ligand 1 (PD-L1).
15862642|NCT03941262|Drug|Pembrolizumab|Pembrolizumab is a humanized monoclonal antibody immune checkpoint blockade immunotherapy that targets the programmed cell death receptor-1 (PD-1).
15862643|NCT03941236|Drug|dasiglucagon|Glucagon analog
15862644|NCT03941223|Procedure|PECSII and paravertebral blocks|Regional anesthesia for mastectomy outcomes
15862645|NCT03941210|Other|Detection of molecular Biomarkers|MicroRNA expression profile analysis by flow cytometry
15862646|NCT03941197|Behavioral|Ready and Healthy for Kindergarten Family Literacy program|Participants will participate in 8 parent-child health-themed literacy workshops. Participants will receive 2-3 text messages per week for 8 weeks.
15862647|NCT03941171|Procedure|PAO|PAO will be performed as the trans-sartorial approach or the anterior pelvic approach.
15862648|NCT03941171|Other|Usual care after PAO|Patients commence post-operative rehabilitation as usual and follow the rehabilitation program guided by a physiotherapist specialized in hip problems until 4 months after the operation.
15862649|NCT03941171|Other|PRT|4 months of partly supervised progressive resistance training 2 times per week. After these 4 months (16 weeks), patients receive a free membership to a fitness center near their home address and are encouraged to train on their own 2 times per week until 12 months follow-up with one supervised session per month. The PRT program involves 10-min of warm up followed by 50-min of bilateral resistance exercises including sets of squats, hip extension, hip flexion, and hip abduction.
15862650|NCT03941145|Behavioral|Reduced-Exertion High-Intensity Interval Training (REHIT)|REHIT is a type of Sprint Interval Training (SIT) that has been shown to be efficacious at improving maximal aerobic capacity using a minimal volume of exercise.
15862651|NCT03941132|Drug|Ustekinumab|"Week 0: Loading dose of 6mg/kg Ustekinumab Intravenously.
~Weeks 8, 16, 24, 32, 40, and 48 (6 visits): 90mg Ustekinumab subcutaneously."
15862652|NCT03941132|Drug|Placebo|"Patients allocated to receive placebo will receive respective amounts of a saline-placebo at the same intervals.
~Week 0: Loading dose of 6mg/kg saline intravenously.
~Weeks 8, 16, 24, 32, 40, and 48 (6 visits): 90mg saline subcutaneously."
15862674|NCT03940885|Procedure|Erector spinea plane block group|Which will receive ultrasound-guided erector spinea plane block bilaterally and the local anesthetic injected will be total volume 25 ml on each side consisting of 15ml of 0.5% plus 5 ml 2% lidocaine HCL plus 5 ml saline
15862653|NCT03941119|Other|VR-therapy|Wearing a Virtual Reality head mounted device allows the user to become immersed in a virtual environment. We have assembled a library of 3-10 minute 360-degree films from a variety of nature settings. The VR films were intentionally chosen to be calming in distinctive ways, as supported by the literature around nature visualization and wellbeing. By varying 1) the lengths of the films (3, 5, and 10 minutes), 2) the types of natural elements (greenery, earth, sky, water), 3) distance of view (close-ups, vistas), 4) motion (flowing water, wind in trees), 5) sound, and 6) presence of different elements (humans/animals, scenery, urban sites, etc.), the content provides a wide range of attributes that can be collaboratively selected by the individual, caregiver, or health care provider for each individual. We will display these films on commercially available VR equipment and will provide audio matching the film using commercially available headphones.
15862654|NCT03941106|Device|Accelerated repetitive transcranial magnetic stimulation|Subjects will be given accelerated left sided rTMS and randomized to more of the same accelerated rTMS if not meeting remission criteria for depression or a different type of rTMS on the right side
15862655|NCT03941093|Drug|Pamrevlumab + Gemcitabine + Nab-paclitaxel or Pamrevlumab + FOLFIRINOX|"Drug: Pamrevlumab is administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion.
~Drug: Gemcitabine is administered on Days 1, 8 and 15 of each 28 day treatment cycle via IV infusion.
~Drug: Nab-paclitaxel is administered on Days 1, 8 and 15 of each 28 day treatment cycle via IV infusion.
~Drug: FOLFIRINOX is a combination of several agents administered on Days 1 and 15 of each 28 day treatment cycle via IV infusion. The specific agents are Oxaliplatin, Folinic Acid, Irinotecan, and Fluorouracil."
15862656|NCT03941093|Drug|Placebo + Gemcitabine + Nab-paclitaxel or Placebo + FOLFIRINOX|"Drug: Placebo is administered on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion.
~Drug: Gemcitabine is administered on Days 1, 8 and 15 of each 28 day treatment cycle via IV infusion.
~Drug: Nab-paclitaxel is administered on Days 1, 8 and 15 of each 28 day treatment cycle via IV infusion.
~Drug: FOLFIRINOX is a combination of several agents administered on Days 1 and 15 of each 28 day treatment cycle via IV infusion. The specific agents are Oxaliplatin, Folinic Acid, Irinotecan, and Fluorouracil."
15862657|NCT03941080|Diagnostic Test|fecal sample|patients will collect fecal samples at home prior to treatment and at 3 months after start of treatment at the time of response evaluation using a standard stool-collection-kit.
15862658|NCT03941080|Behavioral|questionnaire|At the day of stool sampling, patients fill out a brief questionnaire about established factors that can change the microbiome such concurrent use of antibiotics and proton pump inhibitors.
15862659|NCT03941080|Diagnostic Test|Blood sample|4 tubes of blood are collected prior to treatment and at 3 months after start of treatment at the time of response evaluation and sent to the UMCG for storage.
15862660|NCT03941067|Other|Pre-event massage|Five minutes massage, combining superficial and high-frequency techniques of massage applied with the therapist hands
15862661|NCT03941054|Other|Pressure Release|Subjets receive digitopressure during 90 seconds for the treatment of the Myosfascial Trigger Points
15862662|NCT03941041|Behavioral|Prenatal Yoga Course|participation in a 12-week prenatal yoga course (optimally), 1 session in duration of 90 minutes per week
15862663|NCT03941028|Device|3D printed titanium implant|The 3D printed titanium implant is fabricated by related companies. And some implants have been used in spinal disease in our hospital.
15862664|NCT03941002|Diagnostic Test|Assesment of diaphragm function|Diaphragm function will be assessed by standard mechanical parameters as assessed by esophageal and gastric pressure measurement, as well as by an ultrasonographic examination performed by an expert operator and by the continuous ultrasonographic assessment provided by the device under investigation
15862666|NCT03940976|Drug|Afatinib|Afatinib is orally administered at 40mg Qd of each 28 day cycle.
15862667|NCT03940963|Device|AxoGuard® Nerve Cap|Entubulation of the nerve stump into the AxoGuard® Nerve Cap following surgical excision of symptomatic neuroma
15862668|NCT03940963|Procedure|Standard Neurectomy|Surgical excision of symptomatic neuroma
15862669|NCT03940950|Biological|Autologous Adipose-Derived SVF (Stromal Vascular Fraction)|60 ml of fat is collected from subjects abdominal wall and SVF is removed from the fat. The SVF is injected into the knee through a needle.
15862670|NCT03940950|Drug|Placebo|Saline control that contains no active ingredient
15862671|NCT03940924|Other|Training program|High Intensity Interval Training + Resistance Training (HIIT + RT)
15862672|NCT03940911|Other|Measurement of aerobic exercise on cycloergometer|"The incremental effects tests will be performed in a service specialized in the exploration of the exercise (physiology or cardiology according to the centers) in a spacious and air-conditioned room, in the presence of a medical specialist. exercise and close to the resuscitation equipment.
~Before the test, weight and height will be collected. Information on the conduct of the test will be given to the patient. A multi-derivation ECG recording will be detected throughout the duration of the test and followed by a physician experienced in the ECG effort.
~O2 saturation by oximetry of hens will be recorded continuously. Blood pressure will be recorded at each level. The collection of expired gases in the face mask whose tightness will be verified to measure the fractions inspired and expired in O2 and CO2 (Sensor Medics Vmax229, Yorba Linda, CA, USA) and calculations VO2 max and VCO2.
~Maximal power (W max) will be recorded Patients will be encouraged during the test."
15862673|NCT03940898|Device|repetitive transcranial magnetic stimulation|"There are two types of stimulation equipment, one is the transcranial magnetic stimulator model Magpro X100 produced by Danish Medtronic, and the other is the CCY-I TMS stimulator produced by Wuhan Eride, model B9076. The stimulating magnetic head uses an 8 shaped coil, and the stimulation site is the cerebellar vermis (ie, 1 cm below the occipital bulge), and the stimulation intensity is 100% of the motor threshold.The base frequency of the iTBS mode is 5 Hz, and one short burst stimulus occurs every 200 milliseconds. In each short array, three single pulses with a frequency of 50 Hz are buried, and each 10 short burst stimulation intervals are 8 seconds, for a total of 200 short burst stimulations. The total number of stimulation pulses is 600 per day.It takes 3 minutes and 20 seconds to complete one intervention. All participants were intervened once a day for 5 times a week for 2 weeks for a total of 10 times."
15862794|NCT03939923|Drug|Neostigmine|Reversal with neostigmine (0.04-0.07 mg/kg up to 5 mg maximal dosage)
15862795|NCT03939923|Drug|Glycopyrrolate|Reversal glycopyrrolate (0.07-0.015mg/kg up to 1 mg maximal dosage)
15862675|NCT03940885|Procedure|Transversus abdominis plane block|Which will receive ultrasound-guided Transversus Abdominis plane block bilaterally and the local anesthetic used will be total volume 25 ml on each side consisting of 15ml of 0.5% plus 5 ml 2% lidocaine HCL plus 5 ml saline
15862676|NCT03940885|Procedure|Control group|this group will receive only standard general anesthesia
15862677|NCT03940872|Diagnostic Test|Self-questionnaire 3PDQ|"Visit 1 : - The patient will have to complete the 3PDQ self-questionnaire. - The investigator will conduct an interrogation and a neurological examination in order to ask or not the diagnosis of parkinsonian primary pain, without knowing the result of the 3PDQ.
~Visit 2 : - The patient will have to complete the 3PDQ self-questionnaire.
~- An investigator, obligatorily different from the investigator of the visit 1, will conduct to the same interrogation and the same neurological examination in order to ask or not the diagnosis of parkinsonian primary pain, without knowing the result of the 3PDQ.
~Visits 1 and 2 can be made on the same day. In this case the patient will fill the 3PDQ self questionnaire only once."
15862678|NCT03940859|Device|intracranial stent, flow diverter and coils|Endovascular treatment was performed under general anesthesia. Patients were treated with internal trapping, stent-assisted coiling or flow diverter as appropriate. After the procedure, patients treated with conventional stent were given 75mg/d clopidogrel for 6 weeks and 100mg/d aspirin for 6months, while patients treated with flow diverter were given 75mg/d clopidogrel for 3 months and 100mg/d aspirin thereafter. All patients were recommended to undergo a 6-month angiographic follow-up.
15862679|NCT03940846|Diagnostic Test|Virtual biopsy|Radiomics -the high throughput extraction of quantitative features from medical imaging- extract features that might potentially decode biologic tumor information, which might ultimately reduce the need to use invasive procedure, such as tissue biopsy.
15862680|NCT03940833|Biological|BCMA CAR-NK 92 cells|The subject will be observed for any side effects during this time and all the adverse events will be recorded.
15862681|NCT03940820|Biological|ROBO1 CAR-NK cells|The subject will be observed for any side effects during this time and all the adverse events will be recorded.
15862682|NCT03940807|Drug|11.25mg GnRH agonist|"Ultra-long protocol group women will receive one intra-muscular administration of 11.25 mg GnRH agonist (triptorelin acetate) on the luteal phase of their menstrual cycle. Ovarian stimulation will be started after 90 days desensitization.
~After the desensitization period, all patients will undergo standardized ovarian stimulation, follicular aspiration, fertilization of all oocytes using either standard insemination or ICSI according to the features of sperm examination, fresh embryo transfer and luteal phase support."
15862683|NCT03940807|Drug|0.1 mg GnRH agonist|"Long protocol group women will receive a 15-days pituitary down-regulation protocol that consists of daily subcutaneous injection of 0.1mg of GnRH agonist (triptorelin acetate) started on the luteal phase of their menstrual cycle.
~Ovarian stimulation will begin after 15 days desensitization. After the desensitization period, all patients will undergo standardized ovarian stimulation, follicular aspiration, fertilization of all oocytes using either standard insemination or ICSI according to the features of sperm examination, fresh embryo transfer and luteal phase support."
15862684|NCT03940807|Drug|25 µg transdermal oestradiol|Add back therapy (transdermal estradiol, 25μg twice a week) will be administrated throughout down-regulation period.
15862685|NCT03940794|Other|Verbal instruction|Verbal instruction for pelvic floor contraction will be given to participants. A transabdominal Ultrasound examination will be conducted to asses urinary bladder displacement being a marker for pelvic floor muscle function.
15862686|NCT03940781|Behavioral|comprehensive rehabilitation|oropharyngeal rehabilitation, cardiopulmonary rehabilitation, and therapeutic exercise
15862687|NCT03940768|Dietary Supplement|Lactobacillus plantarum 299v|Administration of Lactobacillus plantarum 299v in cancer patients who receive home enteral nutrition.
15862688|NCT03940768|Dietary Supplement|Placebo|Administration of placebo in cancer patients who receive home enteral nutrition.
15862689|NCT03940742|Drug|Tirzepatide|Administered SC
15862690|NCT03940729|Drug|Chlorhexidine Topical|In the Malmö needle exchange program, people who inject drugs (PWID) are repeatedly screened for S aureus colonization during one year. Those colonized will repeatedly shower with chlorhexidine during the following year. The infection frequency will be compared between the two periods.
15862691|NCT03940716|Behavioral|IntERact|"This intervention integrates motivational interviewing, cognitive behavioral skills therapy, and care management into a single behavioral counseling intervention delivered by a therapist. The intervention is delivered either in the emergency department or remotely over the subsequent 5 weeks for a total of six therapy sessions (~30 min each). A smartphone app is also loaded on the participant's phone and delivers additional behavioral intervention content, including tailored MI+CBT messages (tailored by daily survey responses), one-touch pro-social contact encouragement, psycho-educational materials, GPS-enabled just-in-time tailored alerts, and facilitated access to care management resources."
15862692|NCT03940703|Drug|Tepotinib|Participants will be administered Tepotinib orally once daily at an initial dose of 500 milligram (mg). A safety monitoring committee (SMC) may decide to confirm or adapt the dose.
15862693|NCT03940703|Drug|Osimertinib|Participants will receive Osimertinib at a dose of 80 mg orally once daily.
15862694|NCT03940690|Drug|Anti-VEGF injections of bevacizumab|5 anti-VEGF injections of bevacizumab at months 0, 1, 2, 4 and 6, combined with laser at months 2, 4 and 6 (laser optional at month 9)
15862695|NCT03940690|Device|Laser|3 sessions of laser at months 0, 1 and 2, completed if needed with laser at months 4, 6 et and 9
15862696|NCT03940677|Procedure|Brain MRI|3 Tesla brain MRI for structural and perfusion evaluation, resting state analysis and functional MRI
15862697|NCT03940677|Procedure|TMS-EEG|Transcranial magnetic stimulation (TMS) coupled with electroencephalogram (EEG) study
15862698|NCT03940677|Behavioral|Behavioral and cognitive battery|Emotional, attentional and behavioral assessment using predefine scales and measures
15862699|NCT03940677|Other|Clinical evaluation and clinical scales|Neurological evaluation, ophthalmologic assessement, Montreal cognitive assessment (MoCA), movement disorder society (MDS)- UPDRS
15862700|NCT03940664|Other|immunohistochemistry on Formalin fixed and paraffin embedded blocks|
15862701|NCT03940651|Drug|Spinal Anesthesia|Patients will be randomized to type of anesthesia
15862702|NCT03940651|Drug|General Anesthetics|Patients will be randomized to type of anesthesia
15862703|NCT03940638|Other|Data collection|Data collection
15862796|NCT03939923|Drug|Sugammadex|Reversal with Sugammadex (2mg/kg)
15862704|NCT03940625|Diagnostic Test|Cardiac MRI and echocardiography, laboratory parameters|Cardiac MRI including cine imaging (volumetric determination of LV-EF), late gadolinium enhancement, strain analysis, T1 mapping and T2 mapping Echocardiography including 3D-EF, diastolic function and strain analysis Determination of laboratory parameters including cardiac enzymes (Troponin T and high sensitivity Troponin T) and cardiac markers (BNP and NT-pro BNP)
15862705|NCT03940612|Dietary Supplement|STP4 (product with probiotics)|STP4 contains Lactobacillus plantarum LP115, Lactobacillus helveticus LA25, Lactobacillus rhamnosus LRH10, Lactobacillus paracasei LPC12, Lactobacillus fermentum LF26, Lactobacillus delbrueckii subsp. lactis, LDL114. Administration at 10 log CFU/day for 8-weeks.
15862706|NCT03940612|Dietary Supplement|Placebo (product without probiotics)|Capsules are similar to STP4 except the presence of probiotics. Administration daily for 8-weeks.
15862707|NCT03940599|Device|step counter|Fitbit
15862708|NCT03940599|Device|weight scale|BodyTrace weight scale
15862709|NCT03940599|Device|step counter with screen covered|Fitbit with screen covered
15862710|NCT03940586|Drug|Letermovir oral granules|Granules administered orally based on age, weight, and whether participant takes cyclosporin A as a concomitant medication.
15862711|NCT03940586|Drug|Letermovir tablet|Tablet administered orally based on age, weight, and whether participant takes cyclosporin A as a concomitant medication.
15862712|NCT03940586|Drug|Letermovir intravenous|Letermovir administered intravenously based on age, weight, and whether participant takes cyclosporin A as a concomitant medication.
15862713|NCT03940573|Device|Eclipse Insert|Rectal Control System.
15862714|NCT03940560|Device|Duramesh Suturable Mesh|Use of Duramesh Suturable Mesh for internal load bearing closures
15862715|NCT03940547|Other|Provision of flour|Infant and young child feeding education and provision of low AF porridge and groundnut flours from 6-18 months
15862716|NCT03940547|Other|Promotion of flour|Infant and young child feeding education and promotion of porridge and groundnut flours from 6-18 months
15862717|NCT03940534|Device|TAD|TAD is a device used to aid medication adherence.
15862718|NCT03940521|Other|Bioclinical evaluation|50-100ml blood extracted for flow cytometry and qPCR
15862719|NCT03940508|Behavioral|Making Connections Intervention|The MCI is a one to two session intervention that addresses barriers to mental health treatment and helps adolescents build skills to get the most out of their treatment experience. It is designed to be delivered by a trained clinician in conjunction with an evidence-based treatment.
15862720|NCT03940508|Behavioral|IPT-A|IPT-A is a time-limited, manualized treatment for depression focused on maladaptive communication patterns and interpersonal interactions.
15862721|NCT03940482|Behavioral|Time Restricted Eating As Treatment (TREAT) for Diabetes.|Participants will skip a meal every day and maintain a water only fast for 16 hours. A fasting diary is kept to track hours of fasting. Participants will follow this new pattern of eating for 12 weeks. They will visit the doctor's office at least 3 times in the course of the study and will be followed up with anthropometry (weight, BMI and waist circumference) and biochemical markers pertaining to Diabetes during the study visits. At 24 weeks, a follow up phone call will be made to check self-reported compliance to intermittent fasting.
15862722|NCT03940469|Drug|Saline|2 ml normal saline
15862723|NCT03940469|Drug|Dexamethasone Injection|8 mg dexamethasone
15862724|NCT03940469|Drug|Dexmedetomidine Hydrochloride|100 microgram dexmedetomidine
15862725|NCT03940456|Other|Questionnaire|Questionnaire mainly focusing on low back pain, pain related disorders, psychosocial factors and the use of alternative treatments for pain
15862726|NCT03940430|Drug|Lactoferrin|This study aims to compare the efficacy of lactoferrin versus iron supplementation versus two combined supplementation on iron deficiency anemia in female medical Ain Shams students by using iron profile.
15862727|NCT03940430|Drug|Ferrous sulfate|This study aims to compare the efficacy of lactoferrin versus iron supplementation versus two combined supplementation on iron deficiency anemia in female medical Ain Shams students by using iron profile.
15862728|NCT03940404|Drug|Anlotinib Hydrochloride|Anlotinib will give orally, once daily on days 1-14 of a 21-day cycle. Dose reduction is allowed.
15862729|NCT03940391|Drug|Chlorpheniramine and midazolam|Administration of chlorpheniramine injection as an adjunctive sedative during sedative endoscopy.
15862730|NCT03940391|Drug|Midazolam|Administration of midazolam as a sedative during sedative endoscopy as routine clinical practice.
15862731|NCT03940378|Drug|Levamisole Hydrochloride|Levamisole Hydrochloride Levamisole Hydrochloride 25mg/tablet; 150mg/d; po;
15862732|NCT03940378|Drug|Anlotinib Hydrochloride Capsules|Anlotinib Hydrochloride Capsules Anlotinib Hydrochloride Capsules 12mg / capsule; 12mg/d; po;
15862733|NCT03940365|Device|Fetal Life tocometer device|The fetal life tocometer device is a uterine contraction monitor which is less expensive to manufacture than existing contraction monitor devices and which pairs with a smart device rather than a bulky output device.
15862734|NCT03940352|Drug|HDM201|Capsule
15862735|NCT03940352|Biological|MBG453|LIVI (Liquid in vial) Concentrate for Solution for infusion
15862736|NCT03940352|Drug|Venetoclax|Tablet
15862737|NCT03940339|Other|Suboccipital myofascial release|The MFR technique will be given in the upper cervical region with the patient in supine position. The MFR will be given for three repetitions per session, three times per week for the period of four weeks.
15862738|NCT03940339|Other|Conventional Physiotherapy|The control group will be receiving conventional physiotherapy treatment for hamstring tightness which includes static stretching, modified hold-relax stretching and contract relax technique.
15862739|NCT03940326|Drug|Levetiracetam|Levetiracetam with initial dose of 500 mg per 12 hours which will be increased 500 mg/week to target dose of 2000 mg/day and the dose could be increased to 3000 mg/day if seizures recurred
15862740|NCT03940326|Drug|Valproate|Sodium valproate with initial dose of 500 mg/day which will be increased 500 mg/week to target dose of 1500 mg/day and the dose could be increased to 2000 mg/d if seizures recurred.
15862741|NCT03940313|Procedure|Prolotherapy|Musculoskeletal injection of lidocaine + 15% dextrose into damaged tissue
15862791|NCT03939936|Other|Non-surgical periodontal treatment|Non-surgical periodontal treatment was performed baseline and after 8 weeks. Saliva samples were taken from patients for the evaluation of proinflammatory cytokine baseline and after 8 weeks.
15862855|NCT03939481|Drug|Chemotherapy|Given chemotherapy regimen
15862742|NCT03940300|Dietary Supplement|Fresh organic vegetables|"Individual participation in this program will take 12 weeks, from screening and enrollment through evaluation. Once enrolled, visits will occur on a weekly basis to ensure that participants receive each week's dose of fresh organic vegetables. At an optional Visit 13, offered 6 months after Visit 1, an additional health screening will be conducted."
15862743|NCT03940287|Other|Muscle Energy Technique|"Muscle energy technique will be given in two different position. For anterior in- nominate rotation and posterior in- nominate rotation patient position will be in supine lying position.
~For weakened muscle,piriformis application the patient should be side-lying position, close to the edge of the table, affected side uppermost, both legs flexed at hip and knee.
~The therapists stand facing the patient at hip level,then patient should be close enough to the edge of the table for the therapist to stabilize the pelvis against his trunk. The angle of hip flexion should not exceed 60°, and then places one hand on the contralateral ASIS to prevent pelvic motion, while the other hand is placed against the lateral flexed knee as this is pushed into resisted abduction to contract piriformis.
~Isometric contraction should be hold for 3-5 second and that particular method will be repeated for 7-10 times."
15862744|NCT03940287|Other|Kinesiotape application|"Kinesiotaping will be applied to piriformis muscle and Sacroiliac joint (SIJ). This tape will be applied in I shape to both sides of the spine from sacrum to Anterior Superior Iliac Spine. For SIJ taping same 5 cm KT tape will be used, it will be applied from below posterior sacroiliac spine to opposite side. Here patient should be in standing position.
~For Piriformis application patient will be in side lying position where the affected leg will be placed uppermost with hip in flexion, adduction, and internal rotation , then the application will be performed. The base of the tape will be placed over contralateral part of sacrum and then make a Y strip with no tension will be attached over the greater trochanter of femur."
15862745|NCT03940287|Other|Conventional physiotherapy|Hydro-collator pack will be used superior to the affected area for at-least 15 minute to reduce the stiffness. Hydocollator pack will be wrap twice with a thick towel and then it will be placed to the affected part.
15862746|NCT03940274|Behavioral|walking training|Participants will receive three sessions a week of BWSTT with assistive training device for 8 weeks; a total of 24 sessions. The duration of each training session will an hour. During walk-training, the participant will wear a harness which is attached to an overhead motorized lift to provide body-weight support and to prevent the risk of falling.
15862747|NCT03940261|Other|High Intensity Interval Training|Participants will complete exercise training 3x/week for 10 weeks. Exercise will consist of 10, 1-minute cycling intervals at 90% of peak power output, each separated by 1-min at 10% peak power output.
15862748|NCT03940261|Other|Continuous Moderate Intensity Training|Participants will complete exercise training 3x/week for 10 weeks. Exercise will consist of 30-50 minutes of cycling at 60% peak power output.
15862749|NCT03940248|Radiation|Proton Accelerated Partial Breast Irradiation|38.5 Cobalt Gray Equivalent (CGE) given over 10 fractions
15862750|NCT03940235|Drug|Androgen deprivation therapy (ADT)|SBRT + ADT
15862751|NCT03940235|Radiation|SBRT|SBRT to all radiological documented lesions (bone or lymphnodes)
15862752|NCT03940222|Device|Interactive Binocular Treatment|The specified system which stimulate the fovea of the amblyopic eye directly by detailed and movable objects, while the fixation of the non- amblyopic eye will be focused on fixed targets.
15862753|NCT03940222|Procedure|Patching Therapy|Patching of the dominant eye with better best corrected visual acuity
15862754|NCT03940209|Behavioral|Basic needs navigation|Navigators will help participants address unmet basic needs for 6 months by telephone. Either party can initiate a call. On every call, navigators will: (1) review unmet needs previously reported (baseline survey for first call) and ask participants to report new needs; (2) jointly prioritize among multiple needs based on severity and resource availability; (3) identify community resources that could help solve the problem; (4) evaluate eligibility for those resources; and (5) prepare participants to interact with service agencies and/or act as an advocate on their behalf. On each subsequent call, navigators will review progress toward resolving those needs, assess emergent needs, and adapt priorities accordingly. Navigators will provide instrumental and emotional social support through regular friendly contact, and will attempt to reduce barriers to needs resolution to improve stability and security for participants longer-term.
15862755|NCT03940196|Device|NovoTTF-100L(O)|Patients receive continuous TTFields treatment using the NovoTTF-100L(O) device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the abdomen/pelvis. The treatment enables the patient to maintain regular daily routine.
15862756|NCT03940196|Drug|Paclitaxel|Paclitaxel 80 mg/m^2 intravenous infusion will be administered weekly for 8 weeks and then on Days 1, 8 and 15 of each subsequent 28-day cycle.
15862757|NCT03940183|Drug|Trelagliptin Succinate|the experimental group will use trelagliptin succinate 100 mg for 24weeks
15862758|NCT03940183|Drug|Placebo Oral Tablet|the placebo Comparator groups use placebo oral tablet for 24weeks
15862759|NCT03940170|Device|vistacam proof|Light fluorescence device
15862760|NCT03940170|Other|ICDASII|visual examination
15862761|NCT03940170|Procedure|fissurotomy|histological validation
15862762|NCT03940157|Behavioral|Oh Happy Day Class - Still I Rise|one-time, 4-hour class focused on awareness of depression and healthy self-management strategies
15862763|NCT03940144|Device|the enhanced flow-based hemodynamic parameters of the FloTrac/Vigileo device|Stroke volume variation (SVV)-guided fluid therapy
15862764|NCT03940131|Drug|Panitumumab|FOLFOX6 regimen consists of 2-hour infusion of oxaliplatin (85 mg/m2) and 2-hour infusion of leucovorin (400 mg/m2 ) on Day l, followed by 5-fluorouracil bolus (400 mg/m2) on Day 1 and 46-hour infusion (2.4 g/m2). FOLFOX6 regimen will be repeated at 2-week intervals. FOLFIRI regimen consists of 2-hour infusion of irinotecan (180 mg/m2) and 2-hour infusion of leucovorin (400 mg/m2 ) on Day l, followed by 5-fluorouracil bolus (400 mg/m2) on Day 1 and 46-hour infusion (2.4 g/m2). FOLFIRI regimen will be repeated at 2-week intervals.
15862765|NCT03940118|Device|Catheter secretion suctioning|Catheter secretion suctioning with prior nebulization of hypertonic saline
15862766|NCT03940118|Combination Product|Secretion suctioning + hypertonic saline|Catheter secretion suctioning with prior nebulization of hypertonic saline
15862767|NCT03940118|Device|Ins-exsufflation|Application of a mechanical insufflation-exsufflation device for respiratory tract secretion suctioning
15862768|NCT03940118|Combination Product|Ins-exsufflation + Hypertonic saline|Application of a mechanical insufflation-exsufflation device for respiratory tract secretion suctioning
15862769|NCT03940105|Behavioral|Packout|Each packout provided during 3 of the 4 snack patterns will contain a variety of foods to be consumed, ad libitum, throughout the remainder of the day following the standardized lunch. There are 3 different packouts that will be provided for 3 nonconsecutive weekdays (for a total of 9 packouts). Each packout contains the same calories and types of foods. However, they differ in packaging size and variety.
15862770|NCT03940092|Other|MRI|"This is a prospective, non-randomised, exploratory study on healthy female volunteers (>18 years), and female patients (>18 years) diagnosed with primary breast cancer.
~Healthy volunteers will be scheduled for an 23Na-MRI examination.
~Patients scheduled for primary surgery will undergo an MR examination, involving 23Na-imaging prior to their planned surgery."
15862771|NCT03940092|Other|PET/MRI|Patients undergoing neo-adjuvant chemotherapy will undertake up to two (2) combined PET/MR examinations with FDG and 23Na-MRI
15862772|NCT03940079|Device|computer-based cognitive game (including 3 training tasks)|"First task was short-term memory training. Participants were instructed to memorize different colored circles with ordinal numbers which would disappear later. They triggered correct colored sensor in sequence according to their memory.
~Second task was divided attention training. Different colored circles with ordinal numbers would not disappear this time.The participants should trigger correct colored sensor according to their sequence.
~Third task was inhibitory function training. There were red and green lights, just like the traffic light, hung up at the upper left of the scene. Red light represented prohibition of triggering the colored sensor, while green light urged to trigger it. Yellow, red, blue and green circles showed up randomly and moved toward the beige region. When the circle came extremely closer to the beige region, the traffic light was randomized to lighten up red or green.The participants should judge and trigger the correct colored sensor."
15862773|NCT03940066|Device|Biomonitor-2 and Kardia mobile|Implantable cardiac monitor and Smart-phone based electrocardiogram recording
15862774|NCT03940066|Other|No Intervention|No intervention
15862775|NCT03940053|Drug|Arginine hydrochloride|Arginine hydrochloride injection 5g/dose; 40g/d; ivgtt; sustained medication for 24 days; drug withdrawal for 4 days. Treatment is continued until the levels of tumor marker dropped to normal
15862776|NCT03940040|Other|Usual care|Usual Care
15862777|NCT03940040|Other|High flow nasal oxygen|High flow nasal oxygen
15862778|NCT03940027|Procedure|EUS-guided celiac plexus neurolysis|EUS-guided celiac plexus neurolysis (EUE-CPN) is an endoscopic ultrasound-guided injection of local anesthetics and neurodegenerative agents into the abdominal ganglion area through the gastric wall, so as to achieve irreversible damage of the abdominal nerve and interrupt the pain pathway of pancreatic cancer.EUS-CPN has the advantages of less trauma, higher technical success rate and lower risk of complications compared with traditional ct-guided CPN in vitro puncture.The data showed that eus-cpn was effective in the treatment of pancreatic cancer related persistent abdominal pain up to about 70%, significantly reducing the dosage of analgesics and improving the quality of life of patients with advanced pancreatic cancer.
15862779|NCT03940014|Other|Data collection from standard follow up|"Annual clinical consultation with an Hereditary Haemorrhagic Telangiectasia (HHT) specialist and/or pneumologist and organ specialists when necessary (such as hepatologists, cardiologists and neurologists).
~Explorations (contrast echography, chest Computed Tomography and treatments performed according to international guidelines.
~TransCatheter Embolotherapy for each treatable Pulmonary Arteriovenous Malformations (PAVMs) and follow-up every 3 years.
~Chest Computed Tomography (CT) every 6-12 months."
15862780|NCT03940001|Biological|Sintilimab|Other Name: (IBI308)
15862781|NCT03940001|Drug|carboplatin/paclitaxel|carboplatin AUC 2/paclitaxel 50 mg/m2 weekly
15862782|NCT03940001|Radiation|Radiation|IMRT or VMAT
15862783|NCT03939988|Radiation|Photobiomodulation|Immediately after the installation of the separators, the subjects will be submitted to photobiomodulation. The laser will be infrared, in continuous mode with wavelength of 808 nm. The tip will be positioned perpendicularly in the mucosa, without exerting pressure. At each point 2J of energy will be irradiated for 20 seconds, totaling 12J per tooth, 6J on the buccal side and 6J of the lingual side of the teeth.
15862784|NCT03939988|Radiation|Placebo photobiomodulation|In the placebo group, the same procedures will be made, but the laser will be turned off.
15862785|NCT03939975|Drug|pembrolizumab or nivolumab or JS001|ICIs therapy of nivolumab (3 mg/kg, per 2 weeks) or pembrolizumab (2 mg/kg, per 3 weeks) or JS001 (240mg, per 3 weeks) was performed until the off-treatment criteria were met. For participants with stable disease or atypical progression to ICIs therapy, thermal ablation of radiofrequency ablation or microwave ablation was performed addtionally.
15862786|NCT03939962|Drug|SHR1210 combined with FOLFOX|"SHR1210, iv, 200 mg d1, 30-minute intravenous infusion, repeated every 14 days.
~mFOLFOX6:Oxaliplatin 85mg/m2 ivgtt 2h d1,5-fluorouracil 400mg/m2 iv d1,leucovorin 400mg/m2 ivgtt 2h d1,5-fluorouracil 2.4mg/m2 CIV 46h, repeated every 14 days Patients who have no disease progression and can tolerate surgery receive surgery. When the investigator believes that the patient is not suitable for continued medication or according to the RECIST 1.1 standard, the evaluation is PD and the medication is over. The PD-1 monoclonal antibody does not allow for reductions and can only delay or suspend medication."
15862790|NCT03939936|Other|Psoriatic measurements|Psoriasis Area and Severity Index (PASI) was performed baseline and after 8 weeks. Saliva samples were taken from patients for the evaluation of proinflammatory cytokine baseline and after 8 weeks.
15862792|NCT03939936|Other|saliva samples|Saliva samples were taken from patients for the evaluation of proinflammatory cytokine baseline and after 8 weeks.
15862797|NCT03939910|Device|Pudendal Nerve Block needle in pre-packaged kits that include both the trumpet and the needle. The needle will limits its depth of penetration to 5 mm beyond the trumpet.|Patients will receive a pudendal nerve block injection on each side as previously described 5-10 minutes before the beginning of surgery. A tubular director that allows 1.0-1.5 cm of a 15-cm-long, 22-gauge needle to protrude beyond its tip will be used to guide the needle into the pudendal trunk at lesser sciatic foramen about 1 cm inferior-medial to attachment of the sacrospinous ligament to the ischial spine. The end of the director will be placed against the vaginal epithelium just beneath the tip of the ischial spine. The needle pushed beyond the tip of the director, and 5 ml of the anaesthetic solution will be injected. The needle advanced 1 cm posterior and lateral, and another 5 mL of the anaesthetic solution will be injected into this region.
15862798|NCT03939897|Drug|Abemaciclib|Given PO
15862799|NCT03939897|Drug|Copanlisib Hydrochloride|Given IV
15862800|NCT03939897|Drug|Fulvestrant|Given IM
15862801|NCT03939884|Drug|MuscleCare Topical Product|Application of the product will be applied with six circular applications over the trigger point and left to rest for 7 minutes.
15862802|NCT03939884|Drug|Voltaren Topical|Application of the product will be applied with six circular applications over the trigger point and left to rest for 7 minutes.
15862803|NCT03939884|Drug|Nivea, Topical Cream|Application of the product will be applied with six circular applications over the trigger point and left to rest for 7 minutes.
15862804|NCT03939871|Drug|fluvestrant + oral vinorelbine|Eligible patients will be treated with the fluvestrant + oral vinorelbine regimen until the disease progresses or intolerable toxicity
15862805|NCT03939858|Procedure|Cognitive Assessment|Tests have been selected to represent a range of cognitive functions affected by cancer and radiotherapy including basic attention, recent memory, executive functions (spanning verbal fluency, cognitive set-shifting, and abstract reasoning), and visual perceptual/spatial skills.
15862806|NCT03939858|Diagnostic Test|Blood Collection|16 ml of blood will be collected before 10 a.m. and after the participant has fasted for 8 hours. White blood cells and platelets will be used for respirometric analysis. Plasma will be additionally processed and saved in 500uL aliquots(x2) and the remainder in 1mL aliquots at -80°C.
15862807|NCT03939858|Diagnostic Test|Bioenergetic Profiling|Peripheral blood mononuclear cells (PBMCs) and platelets will be separated from the blood. Primary respirometric parameters will be measured with high-throughput respirometry using the Agilent Seahorse 24XFe. Additional parameters will be collected with high-resolution respirometry using the OROBOROS Oxygraph-2k. Both methods will report a variety of mitochondrial parameters resulting in 48 measures per participant, creating robust profiles of bioenergetic health. Additional analysis will include western blots to enumerate protein density for the five major mitochondrial complexes, mtDNA copy number analysis, and citrate synthase activity as these assays provide different but complementary data to respirometry for a more dynamic picture of mitochondrial metabolism.
15862808|NCT03939845|Radiation|RT|external- beam radiotherapy (EBRT)
15862809|NCT03939845|Procedure|TACE|transarterial chemoembolization (TACE)
15862810|NCT03939832|Other|Fraction of inspired oxygen level|A fraction of inspired oxygen level during cardiac surgery using cardiopulmonary bypass will be set differently: 0.5 versus 1.0.
15862811|NCT03939819|Device|ViSiGi® 3D suction calibration device|ViSiGi 3D®is a non-sterile, single patient use device. The device comprises a tube with a closed, rounded tip, and holes at the distal end. The proximal end of ViSiGi 3D® includes an integral suction regulator and vented On/Off valve.
15862812|NCT03939819|Device|Esophagogastroduodenoscopy (EGD) calibration|Gastroscope is an illuminated optical, slender and tubular instrument (a type of borescope) used in esophagogastroduodenoscopy.
15862813|NCT03939806|Drug|Oxytocin|To be given to Oxytocin group following the clamping of the umbilical cord
15862814|NCT03939806|Drug|Carbetocin|To be given to Carbetocin group following the clamping of the umbilical cord
15862815|NCT03939793|Behavioral|IMPaCT Community Health Worker|"Once a CHW receives notification of a struggling patient, the CHW will visit the patient at their home within 1-2 days to initiate the IMPaCT intervention.
~Elements of the standard IMPaCT intervention: During the first home visit, the CHW will use an in-depth semi-structured interview guide to get to know patients holistically and assess for unmet socioeconomic needs. This allows patients to express goals in line with their own needs and preferences. These individualized goals will become the basis for tailored action plans. The CHW will then provide hands-on, tailored support for the remainder of the 24-week study period to help patients achieve their goals.
~Additional elements to help patients cope with failure: In this study, we will test a refined version of IMPaCT that incorporates two behavioral techniques for coping with failure: positive affect induction and attribution retraining."
15862816|NCT03939793|Behavioral|Digital health monitoring with financial incentives|Participants are encouraged to use their glucometer to check their blood glucose via bidirectional texting and lottery-based financial incentives, which both serve to reinforce self-monitoring behavior.
15862817|NCT03939793|Other|Usual Care|Usual Care
15862818|NCT03939780|Diagnostic Test|[F18]RO-948|Single radiotracer IV injection with subsequent emission scan
15862819|NCT03939780|Diagnostic Test|[F18]MK-6240|Single radiotracer IV injection with subsequent emission scan
15862820|NCT03939780|Diagnostic Test|[F18]AV1451|Single radiotracer IV injection with subsequent emission scan
15862821|NCT03939767|Drug|Aflibercept (Eylea, BAY86-5321)|As prescribed by the treating physician according to the local label. No IVT aflibercept will be provided due to a nature of observational study.
15862822|NCT03939754|Behavioral|Dedalo project|Physical activity, healthy food, socialization and mental activity promotion
15862823|NCT03939741|Biological|SVF Containg Autologous Non Expanded ADSC|5 ml of SVF containing Autologous Non Expanded ADSC will be injected intravenously and outcome will be observed over the period of 1(one) year.
15862824|NCT03939728|Radiation|Chest radiography and lung ultrasound|We'll include all patients which have, during their stay in pediatric intensive care unit, in order to have a pleural or pulmonary diagnosis, a chest radiography and then a lung ultrasound, at less than 2 hours interval.
15862825|NCT03939715|Biological|DermaPure®|Surgical intervention using DermaPure®
15862826|NCT03939715|Procedure|native tissue|Surgical intervention using native tissue
15862827|NCT03939702|Drug|BMS-986177|An orally administered anticoagulant to prevent and treat thromboembolic events
15878818|NCT03814005|Drug|Paclitaxel|Paclitaxel intravenous infusion.
15862828|NCT03939689|Drug|I-131-1095|I-131-1095 will be administered intravenously at 100 mCi for the initial therapeutic dose, and up to 3 additional dose(s) at 75 mCi or 100 mCi each, administered at least 8 weeks apart as determined by dosimetry evaluation and occurrence of dose-limiting events.
15862829|NCT03939689|Drug|Enzalutamide|Enzalutamide will be given orally once daily as prescribed by the physician as standard of care.
15862830|NCT03939663|Drug|misoprostol|misoprostol 2 tablets
15862831|NCT03939663|Drug|Placebo|starch pills manufactured to mimic misoprostol 200 mg tablets
15862832|NCT03939650|Device|Diaana|"Diaana, the AMHTD used, functions as follows: on the basis of an interactive questionnaire completed by the patient before the consultation, it performs an exhaustive anamnesis focused on the problem and proposes a panel of DDs with a high sensitivity. The artificial reasoning system of Diaana mimics how a specialist physician would reason to establish a DD. The information transmitted is in an easy-to-use form for the physician that includes a summary of the anamnesis centered on relevant elements from the questionnaire and a list of possible diagnoses with their emergency level, potential contributing factors, and first-line management proposals."
15862833|NCT03939637|Drug|Eltrombopag|"Starting dose for eltrombopag will be based on manufacturer recommendations, and drug will be titrated to effect per guidelines.
~Children 1 to 5 years: Initial: 25 mg once daily
~Children ≥6 years and Adolescents: Initial: 50 mg once daily (25 mg once daily for patients of East-Asian ethnicity [e.g., Chinese, Japanese, Korean, Taiwanese])
~Dose should be titrated based on platelet response. Maximum dose: 75 mg once daily."
15862834|NCT03939637|Drug|Steroids|Prednisone/Prednisolone 4mg/kg/day (Max 120 mg/day) x 4 day
15862835|NCT03939637|Drug|IVIG|IVIG 1 g/kg x1 (no steroids for pre-medication or adjunctive therapy)
15862836|NCT03939637|Drug|Rho(D) Immune Globulin|Anti-D globulin 75 mcg/kg x1 (no steroids for pre-medication or adjunctive therapy)
15862837|NCT03939624|Drug|Sodium-glucose cotransporter 2 (SGLT2) inhibitors|Exposure to SGLT2 will be defined as a prescription for a SGLT2 inhibitor alone (canagliflozin, dapagliflozin, empagliflozin) or in combination with non-DPP4 inhibitor drugs at cohort entry date.
15862838|NCT03939624|Drug|Dipeptidyl peptidase-4 (DPP-4) inhibitors|Exposure to DPP-4 will be defined as a prescription for a DPP-4 inhibitor (alogliptin, linagliptin, saxagliptin, sitagliptin, vildagliptin) alone or in combination with non-SGLT2 inhibitor drugs at cohort entry date.
15862839|NCT03939611|Other|Foot Reflexology|Reflexology is one of the complementary health approaches; it is based on systematic pressure and stimulation with fingers to energy points in feet and hands and is a topic nowadays studied. Reflexology argues that the reflex maps in the hands and feet with all of the parts of the body are in contact. The pressure applied to each point stimulates the circulation of blood and energy like a sensor, gives a sense of relaxation, provides homeostasis. With a touch that is a different way of communication with children, is supported to create physical awareness via reflexology techniques, and is provided healthy nutrition of the stimulated tissue.
15862840|NCT03939611|Other|Placebo Foot Reflexology|Placebo reflexology was performed by touch without pressure to the same rotation and to the same points as foot reflexology application. It was performed only to compare foot reflexology with a placebo effect.
15862841|NCT03939585|Biological|Cellular therapy product|"Cellular therapy product: Allogeneic transplant donor lymphocytes, depleted of TCR-αβ T cells and B cells; enriched for NK cells and TCRγδ T cells.
~Infused using venous catheter on post-transplant Day 28 (+ 7 days).
~Single infusion of entire lymphocyte product derived from two-blood volume leukapheresis (non-mobilized)."
15862842|NCT03939572|Behavioral|Accurate step count feedback|After one week of baseline step count measurement, participants will receive the intervention. Starting day 8, participants' Apple Watches will start displaying their step count. In this arm, they will simply see their accurate step count.
15862843|NCT03939572|Behavioral|Deflated step count feedback|After one week of baseline step count measurement, participants will receive the intervention. Starting day 8, participants' Apple Watches will start displaying their step count. In this arm, they will see their step count deflated by 40% (i.e., their step count multiplied by 0.6).
15862844|NCT03939572|Behavioral|Inflated step count feedback|After one week of baseline step count measurement, participants will receive the intervention. Starting day 8, participants' Apple Watches will start displaying their step count. In this arm, they will see their step count inflated by 40% (i.e., their step count multiplied by 1.4).
15862845|NCT03939572|Behavioral|Accurate feedback + mindset intervention|"After one week of baseline step count measurement, participants will receive the intervention. Starting day 8, participants' Apple Watches will start displaying their step count. In this arm, they will simply see their accurate step count.
~Additionally, participants in this arm will receive a meta-mindset intervention in the first weekly survey on day 7, which consists of a series of videos and reflection exercises to teach participants about the power of mindsets and encourage them to choose adaptive mindsets that will benefit their health. There are also short booster reflection exercises in all subsequent daily and weekly surveys, reinforcing the message about adaptive mindsets."
15862846|NCT03939559|Procedure|Static, dynamic and functional balance exercises|In the first group (G1), 4 exercise packages which include static, dynamic and functional balance exercises will be taught in the first part of exercise period for 4 weeks
15862847|NCT03939559|Procedure|Static, dynamic and functional balance exercises with dual task|In the second group (G2), 4 exercise packages which include static, dynamic and functional balance exercises with cognitive or motor dual task will be taught in the first part of exercise period for 4 weeks.
15862848|NCT03939546|Other|B. infantis EVC001|"Bifidobacterium longum subspecies infantis strain EVC001, designated a Foods for Special Dietary Use (FSDU)"
15862849|NCT03939533|Drug|CUTAQUIG|Human normal immunoglobulin
15862850|NCT03939520|Drug|pirfenidone and nintedanib|The experimental group will receive pirfenidone 2403 mg per day (at least 1602 mg) in combination with nintedanib 300 mg per day (at least 200 mg) during 24 weeks.
15862851|NCT03939520|Drug|pirfenidone or nintedanib|The second intervention group will switch from one monotherapy during 24 weeks: with pirfenidone 2403 mg per day (at least 1602 mg) or nintedanib 300 mg per day (at least 200 mg) to the other monotherapy (nintedanib in patients who received pirfenidone as first line therapy before inclusion and conversely).
15862852|NCT03939520|Drug|pirfenidone or nintedanib|The control group will keep on the same monotherapy during 24 weeks: with pirfenidone 2403 mg per day (at least 1602 mg) or nintedanib 300 mg per day (at least 200 mg) to the other monotherapy (nintedanib in patients who received pirfenidone as first line therapy before inclusion and conversely).
15862858|NCT03939468|Device|DES+DCB|A hybrid strategy is defined as overlapping or slightly (2-3 mm) superimposing a new generation DES implantation for a de novo lesion (located in the larger, more proximal part of the vessel) and DCB inflation for a concomitant de novo small vessel disease
15862859|NCT03939455|Other|Mobile Augmented Screening tool|Tablet-based intervention
15862860|NCT03939442|Procedure|Sleeve gastrectomy with jejunoileal anastomosis|The sleeve gastrectomy was performed first, after using a sealer and divider device to dissect the omentum away from the greater gastric curvature from approximately 5 cm proximal to the pylorus up to the angle of His. Excision of the fundus and the body of the stomach was then performed with a laparoscopic linear stapler upon a 36 French orogastric tube (bougie). An isoperistaltic side-to-side anastomosis between the jejunum (at 50 cm distal to the Treitz ligament) and the distal ileum ( at 200 cm proximal to the ileocecal valve) was then created using the same linear stapler with a blue cartridge (3.5 mm). A soft Penrose drain was left at the subdiaphragmatic space, and the abdominal wound was closed.
15862861|NCT03939429|Drug|QPX2015|antibiotic
15862862|NCT03939429|Drug|Placebo oral capsule|Placebo comparator
15862863|NCT03939416|Other|Experimental|"STANDART
~Physical exercise: degreed joint mobilization, self muscle elongation and postural correction.
~Sophrology: mental control of insomnia and painful perception
~Cognitive behavioral therapy: analysis of non-assertive relationship patterns or dependence, dysfunctional beliefs, as well as their consequences, psychoeducation of the disease. Strategies for pain management, anxiety, assertiveness and acceptance of the disease
~POLD
~Rhythmic transversal muscle mobilization in posterior chain musculature.
~General vertebral decompression from the sacrum and pelvis
~Metameric subcutaneous mobilization
~Rhythmic vertebral mobilization from the spinous processes."
15862864|NCT03939416|Other|Control|"STANDART
~Physical exercise: degreed joint mobilization, self muscle elongation and postural correction.
~Sophrology: mental control of insomnia and painful perception
~Cognitive behavioral therapy: analysis of non-assertive relationship patterns or dependence, dysfunctional beliefs, as well as their consequences, psychoeducation of the disease. Strategies for pain management, anxiety, assertiveness and acceptance of the disease"
15862865|NCT03939403|Drug|Time of administration of Corifollitropin Alfa|"The used treatment will be identical in both arms. The difference between the groups will be the moment of beginning of the stimulation as well as the later administration of more FSH activity.
~The control grup will receive the treatment on the 5th day after the cessation of hormonal contraceptive use. The used treatment will be identical in both arms. The difference between the groups will be the moment of beginning of the stimulation as well as the later administration of more FSH activity.
~The intervention grup will receive the treatment on the 7th day after the cessation of hormonal contraceptive use."
15862866|NCT03939390|Drug|time of administration of Corifollitropin Alfa|The treatment will be identical in both arms. The difference between the arms is the moment of the Administration of Corifollitropin Alfa: follicular phase of the menstrual cycle (control group) vs. luteal phase of the menstrual cycle (study group).
15862867|NCT03939377|Other|Questionnaire and treatment|EVA questionnaire every day for 7 days. treatment (real or simulated) at J3 and J5
15862870|NCT03939351|Diagnostic Test|OCT-angiography and SD-OCT|Performing an OCT-angiography and SD-OCT examination
15862871|NCT03939338|Other|Treg levels and CMR results|This is an observational study. Exposure: Different Treg levels and CMR results.
15862872|NCT03939325|Radiation|ESWL|The impact of different frequencies on pattern of disintegration of renal stones
15862873|NCT03939312|Drug|Atogepant 60 mg|Tablet containing Atogepant 60 mg
15862874|NCT03939299|Procedure|OCT|Patients with coronary chronic total occlusion received successful stenting. Optimal coherence tomography imaged immediately and at 9-12 months after the index procedure to explore long-term vascular response and healing profile.
15862875|NCT03939286|Other|Clinical-neurological and neuropsychological tests|The tests include established standardized questionnaires and detailed clinical neuropsychological examinations (e.g., tests on cognition and perception). In order to avoid exercise effects in multiple examinations, so-called parallel procedures should be used.
15862876|NCT03939286|Diagnostic Test|Blood sampling|Venous blood sampling (40 ml) is performed according to the usual criteria of sterile working at baseline and after intervention.
15862877|NCT03939286|Other|Assessment of physical activity via fitness tracker/diary|All study participants, regardless of group classification, are randomly selected for a period of one week using Fitbit Charge 2® fitness trackers. The study participants are asked in this context to pursue their regular activity and to wear the bracelets for a week throughout. All study participants are asked to document their activities in a hand-written diary.
15862878|NCT03939286|Other|MRI-examinations|Standard MRI-methods, Sodium MRI, Phosphor MRS, Wholebody-Fat-MRI
15862879|NCT03939273|Drug|Vancomycin Oral|500 mg thrice per day for seven days
15862880|NCT03939273|Drug|Metronidazole Oral|500 mg thrice per day for seven days
15862881|NCT03939273|Drug|Ciprofloxacin Pill|500 mg twice per day for seven days
15862882|NCT03939273|Drug|Fluconazole Oral Product|200 mg once per day for six days
15862883|NCT03939273|Drug|Placebos|seven day course of placebo tablets and capsules identical in appearance and number to active treatment
15862884|NCT03939260|Other|Extracorporeal CO2 Removal|Extracorporeal carbon dioxide removal (ECCO2R), a low flow extracorporeal CO2 removal, may be used in association with ultraprotective mechanical ventilation (tidal volume < 6 ml/kg and Pplat <20-25 cmH2O).
15862885|NCT03939247|Other|Active Tecaretherapy|"The Tecaretherapy: consists of using a specific device providing high frequencies (between 300 kHz and 1 MHz) supposed to accelerate the tissues healing process"
15862886|NCT03939247|Other|Inactive Tecaretherapy|"Inactive Tecaretherapy: the device will not provide any current."
15862887|NCT03939247|Other|CPT|Conventional physiotherapy treatment (massage, eccentric exercises, stretching)
15862888|NCT03939234|Combination Product|PD-L1, PD-L2 peptides with Montanide ISA51|PD-L1: 19 amino acid sequence from the PD-L1 protein; PD-L2: 21 amino acid sequence from the PD-L2 protein; The peptides are dissolved in dimethyl sulphoxide (DMSO) and mixed with Montanide.
15862996|NCT03938207|Diagnostic Test|Whole-genome genotyping|Using Whole-genome genotyping from Taiwan Biobank between Dry eye syndrome and healthy control.
15863161|NCT03936894|Drug|Canakinumab Injection [Ilaris]|Subject receives subcutaneous injection of canakinumab 2 mg/ kg or 4 mg/kg
15862889|NCT03939221|Behavioral|Infrared Lamp and Acupressure|Measure the ankle and wrist acupoints skin conductance to evaluate the basic condition of terminal hospice patients. Then investigators use the infrared lamp and acupressure(tender points, PC6 and ST36 for one minutes) for our patient for the cold limbs, pain control and constipation problems.
15862890|NCT03939208|Behavioral|BRISC|
15862891|NCT03939208|Behavioral|SAU|
15862892|NCT03939195|Other|Follow-up|4 follow-up visits with OCT Angiography and Structural OCT B
15862893|NCT03939182|Drug|Abexinostat|Two doses of the abexinostat will be tested: 30 mg/m2 and 45 mg/m2 orally twice daily, 7 days/week given every other week during a 28-day cycle.
15862894|NCT03939182|Drug|Ibrutinib|Ibrutinib will be given at the FDA-approved dose for mantle cell lymphoma (MCL) of 560 mg orally daily for 28 day cycle.
15862895|NCT03939169|Other|Installation of a naso-gastric feeding tube|Insertion of the feeding tube with skin-to-skin contact or whilst being held in the mother's arms, or by using the four hands technique or by performing positional support with appropriate equipment
15862896|NCT03939156|Other|Completion of questionnaires|Completion of questionnaires at the time of study entry
15862897|NCT03939143|Drug|DA-1229_01(A), Sugamet SR Tab 5/1000mg®|"Period 1: Single oral administration of 1 tablet of test drug together with 150 mL of water containing 30 g sugar.
~The wash-out for fed study is 14 days. Period 2: Single oral administration of 1 tablet of reference drug together with 150 mL of water containing 30 g sugar."
15862898|NCT03939143|Drug|Sugamet SR Tab 5/1000mg®, DA-1229_01(A)|"Period 1: Single oral administration of 1 tablet of reference drug together with 150 mL of water containing 30 g sugar.
~The wash-out for fed study is 14 days. Period 2: Single oral administration of 1 tablet of test drug together with 150 mL of water containing 30 g sugar."
15862899|NCT03939130|Dietary Supplement|Fructose|Consumption of 1.0g / kg of body mass / day of fructose.
15862900|NCT03939130|Dietary Supplement|Glucose|Consumption of 1.0g / kg of body mass / day of glucose.
15862901|NCT03939130|Other|Fructose and exercise|Consumption of 1.0g / kg of body mass / day of fructose + 3 weekly sessions of 60 minutes of aerobic exercise.
15862902|NCT03939104|Drug|Artemether-lumefantrine+amodiaquine|"AL: Currently available as dispersible tablets containing 20 mg of artemether and 120 mg of lumefantrine, in a fixed-dose combination formulation. The flavoured dispersible tablet paediatric formulation facilitates use in young children.
~The dose of artemether-lumefantrine is administered approaching the WHO-recommended target ranges of artemether 5-24 mg/kg and lumefantrine 29-144 mg/kg over 3 days.
~AQ: Amodiaquine is available as dispersible tablets of 40 mg. The weight-based treatment schedule aims for a dosage of approximately 10mg (4.5-15mg)/kg/day amodiaquine for three days."
15862903|NCT03939104|Drug|Artemether-lumefantrine+placebo|"AL: Currently available as dispersible tablets containing 20 mg of artemether and 120 mg of lumefantrine, in a fixed-dose combination formulation. The flavoured dispersible tablet paediatric formulation facilitates use in young children.
~The dose of artemether-lumefantrine is administered approaching the WHO-recommended target ranges of artemether 5-24 mg/kg and lumefantrine 29-144 mg/kg over 3 days.
~PBO: Placebo tablets for amodiaquine are identical in size, shape and color to the amodiaquine tablets."
15862904|NCT03939104|Drug|Artesunate-mefloquine+piperaquine|"AS: Artesunate will be administered according to an optimised dosing schedule using tablets of 32 or 100 mg artesunate with a dosing target of 4 mg/kg/day.
~MQ: Mefloquine will be administered according to an optimised dosing schedule using tablets of 70 or 220 mg mefloquine hydrochloride with a dosing target of 8.3 mg/kg/day.
~PPQ: Piperaquine will be administered according to an optimised dosing schedule using tablets of 160 or 500 mg of piperaquine tetraphosphate. The weight-based treatment aims for a dosage of approximately
~24 mg/kg/day in patients <25 kg (range 16.0 - 32.0 mg/kg) piperaquine for three days, thereby approaching the WHO-recommended target range of 20 - 32 mg/kg per day.
~18 mg/kg/day in patients ≥25 kg (range 15.0 - 29.4 mg/kg) piperaquine for three days, thereby approaching the WHO-recommended target range of 16 - 27 mg/kg per day."
15862905|NCT03939104|Drug|Artesunate-mefloquine+placebo|"AS: Artesunate will be administered according to an optimised dosing schedule using tablets of 32 or 100 mg artesunate with a dosing target of 4 mg/kg/day.
~MQ: Mefloquine will be administered according to an optimised dosing schedule using tablets of 70 or 220 mg mefloquine hydrochloride with a dosing target of 8.3 mg/kg/day.
~PBO: Placebo tablets for piperaquine are identical in size, shape and colour to the piperaquine tablets."
15862906|NCT03939091|Diagnostic Test|Ultrasonography|Renal Ultrasonography
15862907|NCT03939078|Radiation|CO2 fractional ablative laser|3 intravaginal fractional ablative CO2 laser sessions, with one month interval between them.
15862908|NCT03939065|Device|Sensor Augmented Pump Therapy|Incorporating both insulin pump and CGM technology together (also known as SAP therapy) has the potential to better optimize glycemic control than each device alone. Participants in this arm will receive their insulin dosing via insulin pump and their blood sugars will be monitored using a Continuous Glucose Monitor.
15862909|NCT03939065|Device|Standard of Care with CGM|Participants assigned to this arm will receive conventional diabetes management with daily insulin injections (or on an insulin pump if already on an insulin pump in the outpatient setting) and capillary blood glucose monitoring. These participants will also wear a blinded Continuous Glucose Monitor (CGM) for outcome assessment.
15862910|NCT03939052|Dietary Supplement|Free amino acids intake|Oral consumption of eight hourly experimental meals- -4 tracer free experimental meals containing a mixture of free amino acids and calories from protein free flavoured liquid, protein free cookies and corn oil -4 isotopically labeled experimental meals. The same protocol will be repeated with glycomacropeptide (GMP).
15862911|NCT03939026|Genetic|ALLO-501|ALLO-501 is an allogeneic CAR T cell therapy targeting CD19
15862912|NCT03939026|Biological|ALLO-647|ALLO-647 is a monoclonal antibody that recognizes a CD52 antigen
15862913|NCT03939026|Drug|Fludarabine|Chemotherapy for lymphodepletion
15862914|NCT03939026|Drug|Cyclophosphamide|Chemotherapy for lymphodepletion
15862915|NCT03939013|Diagnostic Test|Xpert HCV VL|Use of Cepheid GeneXpert HCV VL test as diagnostic tool to test for HCV RNA for diagnosis of hepatitis C infection, to test for sustained virological response at 12 weeks post treatment completion
15862997|NCT03938207|Diagnostic Test|Whole-genome sequencing|Using whole-genome sequencing from Taiwan Biobank between Dry eye syndrome and healthy control to investigate the difference among the genetic variant, gene copy number, single nucleotide variation, chromosomal recombination, and very low-level gene expression differences
15863182|NCT03936673|Procedure|Percutaneous nephrostomy|
15862916|NCT03938987|Biological|autologous CD19-directed chimeric antigen receptor (CAR) T-cells|Anti-CD19/4-1BB/CD3ζ CAR T-cell: autologous, unselected CD3+ lymphocytes collected from whole blood or apheresis, transfected with a lentiviral vector containing a 2nd generation chimeric antigen receptor (CAR) consisting of a scFv recognizing CD19 and dual co-stimulatory intracellular signaling domains (4-1BB and CD3ζ). All patients will receive lymphodepleting, conditioning chemotherapy in the form of cyclophosphamide (500 mg/m2/day) and fludarabine (30 mg/m2/day) on Days -5, -4, and -3 prior to a CAR T-cell intravenous, single dose administration on Day 0.
15862917|NCT03938948|Device|low-level laser/light therapy|Participants will wear light therapy devices for 14 weeks
15862918|NCT03938935|Procedure|Absorbable polydioxanone suture (PDS)|PDS is a Polydioxanone synthetic monofilament which is absorbable.
15862919|NCT03938922|Drug|Active Investigational Treatment ENT-01|"ENT-01 will be administered in tablet form, once daily.
~Other Names:
~ENT-01"
15862920|NCT03938909|Genetic|cif mtDNA biomarker|The aim is to evaluate the role of ccf-mtDNA as a specific and early biomarker for different clinical pictures
15862921|NCT03938896|Other|platelet rich plasma|Patients were put in supine position. Betadine was used to disinfect the skin of the heel. 1 ml of local anesthesitic (lidocaine) was injected;then, by the same syringe, 2.5 ml of PRP was injected in the tenderestarea.After extraction of the needle, a bandage was puton the injected area. The patient was kept in the supine position for twentyminutes and then discharged
15862922|NCT03938896|Other|corticosteroid|Patients were put in the supine position. Injection was done usingthe medial technique. Identification of the tenderest point of the heel was done by palpation. Antiseptic solution was used to disinfect the skin overlying theheel. Then1ml of 40 mg methylprednisolone acetate and 1 ml of local anaesthetic as lidocaine 2% were injected into the plantar fascia by a 22gauge needle. After injection, participants were advised to stay sitting without foot movement for 15 minutes
15862923|NCT03938883|Device|Ocular Bandage Gel (OBG)|A modified form of the natural polymer hyaluronic acid, which is a gel that possesses unique physical and chemical properties such as hydrating and healing when applied to the ocular surface. The ability of CMHA-S to adhere longer to the ocular surface, resist degradation and protect the ocular surface makes it well-suited for treating various ocular surface injuries including surgical trauma.
15862924|NCT03938883|Device|Bandage Contact Lens (BCL)|A bandage contact lens protects an injured or diseased cornea from the mechanical rubbing of the blinking eyelids, therefore allowing it to heal. It is a normal (usually soft, but not always) contact lens has no power. It is not intended to improve your vision.
15862925|NCT03938870|Other|L-Leucine 13C6|
15862926|NCT03938857|Drug|Fentanyl|Fentanyl standard of care
15862927|NCT03938857|Drug|Dexmedetomidine|Dexmedetomidine (0.5 mcg/kg + 0.2 mcg/kg/hr)
15862928|NCT03938857|Drug|Dexmedetomidine|Dexmedetomidine (0.5 mcg/kg + 0.5 mcg/kg/hr)
15862929|NCT03938857|Drug|Dexmedetomidine|Dexmedetomidine (0.5 mcg/kg + 0.7 mcg/kg/hr)
15862930|NCT03938844|Procedure|BURCH Colposuspension|stress urinary incontinence surgery ( burch or tot)
15862931|NCT03938844|Procedure|TOT|
15862932|NCT03938831|Drug|Dexmedetomidine|dexmedetomidine 0.5 micg/kg/hr infusion during operation and followed by 0.2 mic/kg/hr with fentanyl-based PCA mixture for 2 days
15862933|NCT03938831|Drug|Fentanyl-based PCA infusion|Fentanyl-based PCA infusion
15862934|NCT03938818|Behavioral|Tu'Washindi intervention|"The intervention includes the following components:
~PrEP sensitization for men (community level). These activities will aim to provide men with basic information about PrEP and will be used to prepare men for more effective engagement in Buddy Days, described below.
~Buddy Days (partner level). Buddy days will target male partner engagement by inviting couples to attend a community-wide event with health screenings, and PrEP sensitization, which aim to facilitate further communications about PrEP and increase men's support for AGYW's PrEP use.
~Adherence support clubs (individual and peer levels). Support clubs will provide a forum for AGYW to discuss challenges and successes around PrEP use in relationships, including in the context of partner violence. Participation in these groups is hypothesized to increase self-efficacy for PrEP use by reducing social isolation and providing additional positive role-modeling from peer leaders."
15862935|NCT03938818|Other|Control|Standard of care will include PrEP delivery according to the usual DREAMS procedures, including attendance at routine Safe Space meetings and routine PrEP provision at the Safe Space, if applicable.
15862936|NCT03938805|Behavioral|Internet-based cognitive behavioral therapy for insomnia|Patients will be provided with psycho education on different cardiovascular diseases, sleep, insomnia, and provided with different behavioral techniques to improve their sleep. The participants in the intervention Group who receives the Internet-based cognitive behavioral therapy program will also have access to support given by a nurse specialized in sleep. A module is given each week during the 9-week intervention.
15862937|NCT03938805|Other|Control group|Control group receiving 3 weeks internet-based education on sleep hygiene. A module is given each week during the 3 weeks.
15862938|NCT03938792|Drug|PF-06741086|300 milligrams(mg) subcutaneous (sc) loading dose followed by 150 mg sq once weekly (qw). 300 mg sc qw is prescribed for participants who meet dose escalation criteria.
15862939|NCT03938779|Behavioral|Pelvic Floor Muscle Training (PFMT)|PFMT is a protocol of exercises for prevention and treatment for Stress Urinary Incontinence in elite females athletes, volleyball team
15862940|NCT03938779|Diagnostic Test|Pad test|Pad test is a standardised test for quantifying urine loss. Pad test is not invasive and provide an easy, inexpensive and objective assessment of urine loss.
15862941|NCT03938766|Diagnostic Test|PSMA PET/CT|Repeat PSMA PET/CT 4 weeks post initiation of clinically indicated ADT in patients with prior negative PSMA PET/CT performed for biochemical recurrence.
15862942|NCT03938753|Device|Audéo M90-T|Receiver in the canal (RIC) Hearing aid form Phonak which will be fitted to the participants individual Hearing loss.
15862943|NCT03938740|Drug|HDV-Insulin Lispro and Insulin Degludec (-40%)|HDV-Insulin Lispro and Insulin Degludec (-40%)
15862944|NCT03938740|Drug|HDV-Insulin Lispro and Insulin Degludec (-10%)|HDV-Insulin Lispro and Insulin Degludec (-10%)
15862945|NCT03938714|Procedure|Hemorrhoidectomy|Excision of third and fourth degree hemorrhoids
15862946|NCT03938701|Drug|OTL38|Intravenous administration of 0.0125 mg/kg OTL38 2-3 hours prior to fluorescence imaging.
15862998|NCT03938207|Diagnostic Test|TCM pattern|We want to use TCM pattern to investigate the difference among Sjögren's syndrome, Dry eye syndrome and healthy subjects
15862947|NCT03938701|Device|Fluorescence Imaging|"Fluorescence Imaging Rheumatoid Arthritis (RA):
~Open-air camera - a camera that enables detection of fluorescent signals.
~Fluorescence Imaging inflammatory bowel disease (IBD):
~Molecular Fluorescence Endoscopy - a flexible fiber-bundle is attached to a fluorescence camera platform to enable the detection of fluorescence signals. The fluorescence fibre-probe is inserted through the standard working channel of the standard clinical endoscope. Fluorescence imaging will be performed during standard clinical colonoscopy."
15862948|NCT03938688|Procedure|Mesh placement with Transfascial Sutures|Sutures that pass through the full thickness of the abdominal wall, which are used routinely for mesh fixation
15862949|NCT03938662|Dietary Supplement|formulation containing S-Adenosyl methionine and choline|Patients will be administered with formulation containing S-Adenosyl methionine and choline once daily for the period of 24 weeks.
15862950|NCT03938662|Dietary Supplement|Placebo|Placebo of same appearance, colour and taste,
15862951|NCT03938649|Radiation|Conventional IMRT|"RapidArc IMRT to prostate and pelvic nodes. 76Gy to prostate, 70Gy to proximal 2/3 of seminal vesicles, and 50Gy to pelvic nodes (up to bifurcation of common iliac nodes).
~38 fractions of daily treatment, Monday to Friday.
~All patients will be given neoadjuvant and adjuvant androgen deprivation therapy."
15862952|NCT03938649|Drug|SBRT|RapidArc IMRT to prostate and pelvic nodes. 40Gy to prostate, 36.25Gy to proximal 2/3 of seminal vesicles, and 25Gy to pelvic nodes (up to bifurcation of common iliac nodes) 5 fractions of weekly treatment. Once fraction per week. All patients will be given neoadjuvant and adjuvant androgen deprivation therapy.
15862953|NCT03938636|Drug|TC99m-tilmanocept|Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
15862954|NCT03938623|Other|Training|Teaching general practitioners to use the patient-centered approach when suggesting colorectal cancer screening
15862955|NCT03938584|Dietary Supplement|Vitamin C|Just after induction of anesthesia in the OR, subjects will be administered a single intravenous (IV) dose of Vitamin C at 66mg/kg/hr for 2 hours during surgery. Post-operatively (beginning the morning after surgery) Vitamin C Treatment Group subjects will receive a 4 week prescription of oral, liquid Vitamin C, 500mg by mouth two times a day. These dosages are known to be safe and effective.89-91
15862956|NCT03938584|Other|Placebo|Subjects will receive IV placebo (normal saline) identically packaged. Post-operatively Placebo Control Treatment Group participants will receive a 4-week prescription of the aqueous solution base used for the treatment group without the active component (Vitamin C).
15862957|NCT03938571|Procedure|Duodenal Switch|
15862958|NCT03938558|Other|MS-Dance|The experimental group will perform 10 weeks of dance training
15862959|NCT03938558|Other|MS-Art|The other group will contribute to the production in various ways (e.g. word art, photography, painting, …)
15862960|NCT03938545|Drug|RVT-1401 (Administered via subcutaneous injection)|RVT-1401 is a fully human anti-neonatal Fc receptor (FcRn) monoclonal antibody.
15862961|NCT03938545|Other|Placebo (Administered via subcutaneous injection)|Placebo
15862962|NCT03938532|Device|Volume Targeted Ventilation (VTV) using the Philips Respironics NM3 monitor|Infants in the intervention arm will receive VTV following intubation. Peak inspiratory pressure (PiP) provided via T-piece resuscitator will be visible to the providers, and the provider can regulate the PiP to achieve the desired TV goal (4-6 ml/kg), at a rate of 40-60 breaths/min
15862963|NCT03938532|Device|Tidal Volume Measurement using the Philips Respironics NM3 monitor|Tidal Volume Measurement using the Philips Respironics NM3 monitor
15862964|NCT03938506|Other|cuff pressure of the endotracheal tube|The endotracheal intubation will be performed after the anesthetic induction. The cuff will be inflated using the air by the palpation method. The cuff pressure of the endotracheal tube will be measured using the manometer.
15862965|NCT03938493|Other|monitoring of the endotracheal tube cuff|We will enroll adult patients who will undergo endotracheal intubation for general anesthesia of head and neck surgery. The cuff pressure of the endotracheal tube will be monitored continuously during anesthesia. The cuff pressure value will be recorded and analyzed after completing the study.
15862966|NCT03938467|Drug|Antiseptic Cleanser|Contains 0.05% Chlorhexidine gluconate in sterile water for irrigation. The mechanical action of the Irrisept system removes bacteria and debris without harming underlying tissues. Irrisept has demonstrated broad spectrum bactericidal activity against antibiotic-resistant strains. Its contents are wrapped in two sequential sterilization wraps which repel water blood, and saline, making it effective against both air and water borne bacteria.
15862967|NCT03938454|Drug|crizanlizumab|Crizanlizumab is a concentrate for solution for infusion, i.v. use. Supplied in single use 10 mL vials at a concentration of 10 mg/mL. One vial contains 100 mg of crizanlizumab
15862968|NCT03938441|Other|Intermittent Fasting|"The version of 5:2 intermittent fasting to be applied in this study will be somewhat less intensive than implemented then what has been proposed in some recent, similar studies.
~On fasting days, instead of limiting the subject to a specific calorie count, the subject will be instead instructed to skip either the first or last meal of the day in order to complete a 12 to 16 hour fast, during which time they are allowed drink water or any non-caloric beverage of their choice, but not consume any calories.
~Furthermore, the patient will be instructed for their remaining 2 meals to consume no more than they would on a normal, non-fasting day."
15862969|NCT03938428|Other|Survey|Patients who are eligible for this study will have been previously identified as part of the PREFACES project. The pharmacist who has conducted the clinical medication review will obtain verbal permission from the patient to be contacted by the research study team. This will be documented on the referral outcome document that is returned to the YAS clinical team. A member of YAS clinical staff from the PREFACES project will forward the name and residential address of patients who have agreed to be contacted to the research paramedic for this study. A covering letter, participant information sheet, questionnaire and consent form, will be posted to potential participants. A stamped addressed envelope will be included to enable return of the completed booklet at no costs to participants.
15862970|NCT03938415|Procedure|Acupuncture|Acupuncture involving the Koffman protocol (body acupuncture) for anxiety control (needles will be placed at bilateral LR-3, bilateral LI-4, GV 24.5 and GV 20) and Auricular ATP Plus (ear) for pain control (needles will be placed at points hippocampus, amygdala, hypothalamus, prefrontal cortex, Point Zero, Shen Men, vagus, insula, external genitalia). Subjects who tolerate the auricular needles will be offered replacement with ASP acupuncture needles for continued pain management post-procedure. The subjects will receive local anesthetic during the vasectomy per standardized clinic protocol.
15862971|NCT03938415|Other|Standardized pre-procedure medications|The clinic standardized pre-procedure medications alone (which include diazepam 5 mg by mouth (PO) x1 30 minutes prior to the procedure, an additional 5 mg PO x1 15 minutes later if desired effect is not achieved; and oxycodone/acetaminophen 5/325 mg PO x 1 30 minutes prior to the procedure. The subjects will receive local anesthetic during the vasectomy per standardized clinic protocol.
15862972|NCT03938402|Other|Positive end-expiratory pressure|Different levels of positive end-expiratory pressure (i.e., 5, 10 and 15 cm H2O) will be applied to the groups.
15862973|NCT03938389|Drug|Sacubitril-Valsartan Tab 97-103 MG|Participants will take Sacubitril-Valsartan for 26 weeks
15862974|NCT03938389|Drug|Valsartan 160mg|Participant will take Valsartan for 26 weeks
15862975|NCT03938389|Drug|Placebo Oral Tablet|Participant with take placebo for 26 weeks or if blood pressure elevated will receive standard of care blood pressure medication, amlodipine.
15862976|NCT03938376|Diagnostic Test|Micro-Ultrasound guided biopsy|High-resolution imaging device
15862977|NCT03938363|Other|Treadmill|Walk on the Biodex Gait Trainer (TM) 3 Treadmill for registration of gait parameters Gait parameters will be evaluated 5 weeks after Botulinum Toxin injection for the two experimental groups and 5 weeks after the first evaluation for the control groups
15862978|NCT03938363|Drug|Botulinum Toxin injection|injection of Botulinum Toxin in the two groups of CD and BS
15862979|NCT03938363|Diagnostic Test|Severity scale of the disease|JRS for BS TWSTRS for CD
15862981|NCT03938337|Drug|Cohort 1 Not Previously Treated|Abemaciclib 150mg by mouth twice daily Pembrolizumab 200mg IV every 3 weeks
15862982|NCT03938337|Drug|Cohort 2 Treated Previously|Abemaciclib 150mg by mouth twice daily Pembrolizumab 200mg IV every 3 weeks
15862983|NCT03938324|Behavioral|PiCASO Intervention Group|This mobile health intervention utilizes an established telephone/text based secure interface to allow AYAs access knowledge, experience, and instrumental/emotional support from a trained peer coach who has already developed independence an active self-manager. Peers with shared experiences provide instrumental (e.g., health maintenance skills) and emotional support that likely lead to improvements in quality of life. Involving peers in supporting AYAs with chronic conditions to promote self-management and patient activation disrupts the typical over-reliance on the parent and health care provider that often impedes developing independence.
15862984|NCT03938324|Behavioral|Sham Comparator: Attention Control Group|Over 12 months the attention control group participants will receive a monthly electronic newsletter with educational content about childhood onset chronic condition management and the differences between pediatric and adult health care systems, as well as a monthly phone call from study staff to ensure receipt of the newsletter and to answer questions regarding content, and an opportunity to link them to other resources. If participants report health concerns they will be directed to contact their health care team.
15862985|NCT03938311|Other|early rehabilitation|"The three study groups share a same intervention protocol in addition to the initiation timing of intervention from the stroke onset. The frequency and intensity of the intervention is titrated according to functional activity baseline and monitored daily and adjusted with recovery. Encourage patients to move out of bed as soon as possible.
~Definition of bed movement: Encourage and help patients to perform functional actions, focusing on activities such as sitting, standing, walking out of the bed."
15862986|NCT03938298|Other|ENDS (vaporizer/e-cig) and smoking cessation counseling|"Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive standards of care, i.e. smoking cessation counseling and encouragement to use NRT. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date and again at week 1, 2, 4 and 8 after the target quit date. All participants will be followed over a 6-month period. After 6 months, participants will be asked to come to a final clinical visit.
~PFT and MBW will be performed at baseline and after the 6 months follow-up period in all participants of the substudy."
15862987|NCT03938298|Other|Smoking cessation counseling|"Participants in the control group will receive standard of care only, i.e. i.e. smoking cessation counseling and encouragement to use NRT. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date and again at week 1, 2, 4 and 8 after the target quit date. All participants will be followed over a 6-month period. After 6 months, participants will be asked to come to a final clinical visit.
~PFT and MBW will be performed at baseline and after the 6 months follow-up period in all participants of the substudy."
15862988|NCT03938285|Other|Theranova 400 membrane|Patients will receive 4 different dialysis treatment, HD with a high flux membrane, extended HD, On Line Hemodiafiltration, and the novel On Line Hemodiafiltration with an MCO membrane.
15862989|NCT03938285|Other|FxCordiax 120 membrane|Patients will receive 4 different dialysis treatment, HD with a high flux membrane, extended HD, On Line Hemodiafiltration, and the novel On Line Hemodiafiltration with an MCO membrane.
15862990|NCT03938272|Biological|Oxabact OC5 - Oxalobacter formigenes Strain HC-1|Live, commensal bacteria
15862991|NCT03938259|Drug|Fentanyl|identification of respiratory parameter changes following administration of fentanyl in children with and without OSA
15862994|NCT03938233|Behavioral|A low-cost DSME program and scalable delivery model for roll-out within the Thai primary care system|The intervention will be based on behaviour-change and social support theories, delivered in monthly group meetings by lay health workers or nurses, and aided by a suite of short films to introduce key topics and stimulate discussion.
15862995|NCT03938220|Device|Electrical Cardiometry|Electrical cardiometry (EC) measurements: by the ICON_ hemodynamic monitor (ICON Cardiotronics, Inc., La Jolla, CA 92307; Osyka Medical GmbH, Berlin, and Germany, model C3, Serial no: 1725303). Four sensors of EC will be applied (1st: 5 cm above the base of the neck, 2nd: on the base of neck, 3rd: lower thorax at the level of the xiphoid and 4th: 5 cm below the 3rd electrode at the level of anterior axillary line). The ICON continuously displays HR, SV and CO.
15862999|NCT03938207|Diagnostic Test|DNA Exome sequencing|The DNA of Sjögren's syndrome, Dry eye syndrome and healthy subjects will take to do the DNA Exome sequencing.
15863000|NCT03938207|Diagnostic Test|Physical examination indicators, blood, urine and biochemical function test|To investigate the difference of Physical examination indicators, blood, urine and biochemical function test among Sjögren's syndrome, Dry eye syndrome and healthy subjects
15863001|NCT03938207|Diagnostic Test|Demographics, personal health behavior, living environment, dietary status, family history|To investigate the difference among the demographics, personal health behavior, living environment, dietary status, family history of Dry eye syndrome and healthy subjects
15863002|NCT03938194|Procedure|Aquablation|a novel minimally invasive water ablation therapy combining image guidance and robotics for the targeted and heat-free removal of prostate tissue
15863003|NCT03938168|Diagnostic Test|Biopsy, fecal sample|Preoperatively and at 12 months after surgery, patients will obtain a fecal stool sample for microbioma analysis. Adhesions that are cut and released to acquire access to the operative field are stored for molecular and histological analyses.
15863004|NCT03938142|Other|Filling in an online survey regarding goalsettings|Patients are asked to fill in an online survey regarding their individual goalsettings.
15863005|NCT03938129|Other|Blood sample|1st trimester blood sample for bio-bank
15863006|NCT03938129|Other|Urine sample|1st trimester urine sample for bio-bank
15863007|NCT03938129|Other|Pregnancy, maternal health, and fetal health data|Pregnancy, maternal health, and fetal health data
15863008|NCT03938116|Other|Healing Hearts Together|Participants in the HHT group will be assembled in groups and attend 8 weekly 2-hr sessions at UOHI led by 2 facilitators with psychology training. Sessions: 1) focus on understanding love, attachment, and their relationship to heart health; 2) provide an opportunity to share experiences related to cardiovascular disease with partners and peers; and 3) assist in identifying and improving communication patterns that may inhibit positive interactions and healthy behaviours. Participants are introduced to concepts through didactic presentations, videos, group and couple discussion and homework exercises. Participants will receive a folder containing copies of in-session and take-home exercises as well as the Hold Me Tight book to review between sessions.
15863011|NCT03938090|Device|Optimised MultiSite Pacing|The intervention includes using optimal programming settings with MultiSite pacing configurations via the patient's CRT device. The device in use is the same for each arm, the only changes are the programming settings.
15863012|NCT03938090|Device|Standard biventricular pacing|Conventional programming settings using biventricular pacing will be used
15863013|NCT03938077|Device|Storytelling 4 Empowerment|S4E application was developed in collaboration with youth in Southeast Michigan. S4E aims to prevent and reduce HIV/STI risk behaviors, including drug use and sexual risk behaviors, and increase HIV testing among youth. Content produced for the application is based on scientific prevention principles in conjunction with youth input. To date, we have developed modules focused on youth alcohol & drug use, HIV & STIs, and tobacco prevention and cessation.
15863014|NCT03938064|Drug|Prontogest 400 mg vaginal pessaries|natural progesterone in the form of vaginal suppositories 400 mg
15863015|NCT03938051|Other|Experimental group|Multicomponent intervention for twice weekly 55-60 minutes 6 weeks
15863016|NCT03938051|Other|Control group|20 minutes treadmill walk thrice weekly, 5-7 /10 subjective rate of perceived exertion
15863017|NCT03938038|Diagnostic Test|Serial ultrasound assessments for GDT|routine ultrasound assessments of volume status and fluid responsiveness for goal-directed therapy (GDT)-based fluid resuscitation
15863018|NCT03938038|Diagnostic Test|Usual care|Close hemodynamic cardiac monitoring and volume responsiveness assessment on an unscheduled basis to aid physicians in resuscitation feedback
15863019|NCT03938025|Procedure|Gastric volume resected in sleeve gastrectomy|Misure of resected gastric volume and outcome
15863020|NCT03937999|Drug|Bezlotoxumab|Injection: 1,000 mg/40 mL (25 mg/mL) solution in a single-dose vial.
15863021|NCT03937986|Drug|Suvorexant|The pharmacodynamic effects of suvorexant maintenance will be determined.
15863022|NCT03937986|Drug|Cocaine|The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and suvorexant.
15863023|NCT03937986|Drug|Placebo oral capsule|The pharmacodynamic effects of placebo will be determined.
15863024|NCT03937973|Behavioral|Social rejection|Social rejection paradigm
15863027|NCT03937934|Behavioral|Nutrition Education|Weekly box of healthy groceries and nutrition education including a recipe, food to make the recipe, extra fruit and vegetables.
15863028|NCT03937921|Drug|Gadavist 15Ml Solution for Injection|Group 2 (n=30) will receive the clinically approved gadobutrol (Gadavist, 0.1mmol/kg) as contrast agent. The contrast agents will be administered at a flow rate of 5.0 ml/s for both groups. In this study aim, all imaging protocols will comply with standard of care and only the perfusion data will be post-processed and analyzed.
15863065|NCT03937648|Drug|Placebo|Placebo
15863066|NCT03937635|Biological|Daratumumab|Given IV
15863067|NCT03937635|Drug|Dexamethasone|Given PO
15863029|NCT03937908|Drug|2g Centella asiatica water extract product|2g of Centella asiatica water extract (CAW) in a standardized product containing excipients to improve palatability, color matching and dispersability. The product (CAP) is a powder which will be dissolved in 10-12 ounce of water and consumed by mouth once on an empty stomach.
15863030|NCT03937908|Drug|4g Centella asiatica water extract product|4g of Centella asiatica water extract (CAW) in a standardized product containing excipients to improve palatability, color matching and dispersability. The product (CAP) is a powder which will be dissolved in 10-12 ounce of water and consumed by mouth once on an empty stomach.
15863031|NCT03937895|Biological|'SMT-NK' Inj (allogeneic Natural Killer cell)|In 120 mL, 3x10^6 (± 20%) cells/kg. weekly administration via Intravenous for 2 weeks. After that, 1 week is a withdrawal period.
15863032|NCT03937895|Drug|Pembrolizumab Injection [Keytruda]|Administration via Intravenous of 200 mg every 3 weeks(one administration per cycle.).
15863033|NCT03937882|Drug|RGN-259|A preservative-free, sterile eye drop solution containing Thymosin beta 4 for direct instillation into each eye, four times a day (QID) for 14 days
15863034|NCT03937882|Drug|Placebo|It is composed of the same excipients as RGN-259 but does not contain Thymosin beta 4
15863035|NCT03937869|Drug|Secnidazole|One dose
15863036|NCT03937856|Behavioral|Calm- Mindfulness Meditation smartphone application|Participants will be asked to register and download the Calm application on participants' phones or home computer. Daily use for a minimum of 5 minutes will be suggested and will be recorded at study end.
15863037|NCT03937843|Drug|Carboplatin|Patients in cohort 1 will receive a 60-minute i.v. infusion of carboplatin AUC 7 at day 1 of treatment.
15863038|NCT03937843|Drug|Cisplatin|"Patients in cohort 2 will receive on day 1 to day 5:
~a 60-minutes i.v. infusion of etoposide 100mg/m2 per day followed by
~a 60-120 minutes i.v. infusion of cisplatin 20mg/m2 per day."
15863039|NCT03937843|Drug|Etoposide|"Patients in cohort 2 will receive on day 1 to day 5:
~a 60-minutes i.v. infusion of etoposide 100mg/m2 per day followed by
~a 60-120 minutes i.v. infusion of cisplatin 20mg/m2 per day."
15863040|NCT03937830|Drug|durvalumab|1,150 mg flat dose every 21 days, starting on day 1 of cycle 1
15863041|NCT03937830|Drug|Doxorubicin-Eluting Beads|used for TACE (only in patients with HCC BCLC stage B)
15863042|NCT03937830|Procedure|TACE|TACE with Doxorubicin-Eluting Beads (only in patients with HCC BCLC stage B) on Cycle 2. More TACE can be done if clinically necessary.
15863043|NCT03937830|Drug|bevacizumab|7.5 mg/kg dose every 21 days, starting on day 1 of cycle 1
15863044|NCT03937830|Drug|Tremelimumab|300 mg once on day 1 of cycle 1
15863045|NCT03937791|Biological|E7 T Cell Receptor (TCR)|One dose of E7 TCR T cells (1x10^11 cells) will be administered intravenously over 20 to 30 minutes.
15863046|NCT03937778|Behavioral|Deep pressure block|Apply deep pressure block by using blood pressure cuff.
15863047|NCT03937765|Procedure|PRP harvest and preparation|"The PRP harvest and preparation will be done in the operating room with the help of the hospital blood bank. The skin graft surgery will be completed by Dr. Jason Lowe and/or one of the Orthopaedic Surgery residents. Follow up will also be completed by Dr. Lowe or one of the residents. Data analysis will be done by Drs. Lowe and Manoharan.
~Each patient that will be undergoing a skin graft surgery will be randomized into either the PRP (intervention) group or the control group. Follow up and dressing changes will be the same for both groups. Each group will be prescribed a multi-modal pain regimen to reduce narcotic usage."
15863048|NCT03937752|Other|3D endodanal ultrasound|Endoanal ultrasound performed with two different transducers preoperatively during a fistula treatment procedure.
15863049|NCT03937739|Other|Nutritional and constipation questionnaire|Alcohol and smoking habits, daily activity, frequency of food consumption and the constipation scoring according to Agachan et all. were examined using questionnaire
15863050|NCT03937726|Other|Boiled peanut|Desensitisation using boiled peanut for induction and initial updosing
15863051|NCT03937726|Other|Defatted roasted peanut flour|Desensitisation using defatted peanut flour for induction and initial updosing
15863052|NCT03937713|Drug|eszopiclone|Eszopiclone is a nonbenzodiazepine benzodiazepine receptor agonists, effective for both sleep onset insomnia and sleep maintenance insomnia
15863053|NCT03937713|Behavioral|Brief behavioral therapy for insomnia|BBTI is based on the core principles that are fundamental to other empirically-supported behavioral treatments of insomnia delivered over four consecutive weeks.
15863054|NCT03937700|Device|CPWalker Robotic Exoskeleton|The CPWalker rehabilitation platform is a robotic device composed by an exoskeleton linked to a walker that provides support and balance to a child during overground training. The device is able to implement user's partial body weight support (PBWS) and allows the adaptation of exercises to the patient's capabilities by means of individual controllers for each joint, which increases the modularity of the system. Each joint of the CPWalker can operate in a range of modes with varied levels of robotic assistance or resistance
15863055|NCT03937687|Drug|Caffeine+TeaCrine+Dynamine|combination of caffeine, TeaCrine, and Dynamine
15863056|NCT03937687|Drug|Placebo|Placebo
15863057|NCT03937687|Drug|Caffeine|Caffeine
15863058|NCT03937674|Behavioral|HeartSteps: A just-in-time intervention for increasing physical activity among sedentary adults.|HeartSteps is a smartphone based mHealth intervention that contains the following intervention components: (1) contextually-tailored suggestions for activity; (2) motivational messages aimed at keeping individuals motivated to be active; (3) planning of the next week's activity; and (4) adaptive weekly activity goals. Activity suggestions provide individuals with suggestions for how they can be active, and are tailored based on time of day, user's location, day of the week (weekend/weekday), and weather. Motivational messages are delivered to individuals via a push notification. Activity planning asks users to create a plan of how they will be active in the coming week. Participants are prompted to plan once a week. Each week, as part of the weekly planning, HeartSteps suggests an activity goal for the coming week based on their activity levels the previous week. Participants can edit the suggested goal, and the system-suggested goals top out at 150 minutes of activity per week.
15863059|NCT03937661|Biological|PRP|Autologous PRP intra ovarian infusion
15863060|NCT03937661|Biological|Placebo|Autologous PFP intra ovarian infusion
15863061|NCT03937648|Drug|COL-144 50mg|COL-144 50mg
15863062|NCT03937648|Drug|COL-144 100mg|COL-144 100mg
15863063|NCT03937648|Drug|COL-144 200mg|COL-144 200mg
15863064|NCT03937648|Drug|COL-144 400mg|COL-144 400mg
15863071|NCT03937622|Other|17 items questionaire|This is a prospective multicenter observational trial. Included patients and attending physician complete a standardised questionnaire.
15863072|NCT03937609|Drug|Infliximab|infliximab iv 5mg/kg
15863073|NCT03937596|Drug|D-cycloserine|Daily oral D-cycloserine 100mg during the blinded phase (10 days).
15863074|NCT03937596|Device|Transcranial Magnetic Stimulator|Repetitive Transcranial magnetic stimulation (rTMS) will be delivered using a MagPro X100 device with B70 coil and the intermittent theta burst (iTBS) protocol to the left dorsolateral prefrontal cortex. Participants will receive daily treatments (Monday-Friday) over four weeks.
15863075|NCT03937596|Drug|Placebo oral capsule|Daily oral placebo during the blinded phase (10 days).
15863076|NCT03937583|Drug|Fludeoxyglucose 18F|"The performance of the 18 FDG PET-CT will require fasting of at least 6 hours, and the glycemia will have to be lower than 126 mg / dL before the injection of 3-5 MBq / kg of 18FDG. Intravenous injection will follow a period of approximately 60 minutes in a quiet room.
~Computed tomography (CT) will be performed from the middle of the forehead to the feet with normal and shallow breathing using a low dose adjustment Iodinated contrast will not be administered intravenously."
15863077|NCT03937570|Device|echo-optimization|LVAD echo-optimization consists of routine comprehensive transthoracic echocardiography at the baseline speed setting, followed by stepwise incremental adjustments to the LVAD speed (revolutions per minute: rpm), with collection of prespecified echocardiographic parameters at each new speed (eg, left ventricle end-diastolic diameter, interventricular septal position, aortic valve opening frequency/duration, tricuspid and/or mitral regurgitation severity). The optimal velocity is defined as the one that allows an intermittent aortic valve opening and a neutral position of the interventricular septum without increasing aortic or tricuspid regurgitation, associated or not to a dilatation of the right ventricle. The recommended speed range varies according to the indications given in the data sheet for each specific device.
15863078|NCT03937557|Diagnostic Test|photofinder levicam|Exam frontal, bilateral Temporal and occipital scalp by photofinder levicam and compare the pros and cons with the data from scalp biopsy.
15863079|NCT03937544|Biological|CD19 CAR-T CELLS|CD19 CAR-T cells will be administered after completion of the chemotherapy.
15863080|NCT03937544|Drug|Cyclophosphamide|Patients will receive lymphodepleting chemotherapies consisting Cyclophosphamide 250mg/m2/day IV(Day -5, Day -4, Day -3 ).
15863081|NCT03937544|Drug|Fludarabine|Patients will receive lymphodepleting chemotherapies consisting of Fludarabine 25mg/m2/day IV (Day -5, Day -4, Day -3 ).
15863082|NCT03937531|Procedure|Bladder Scanner|PVR will be measured by using a bladder scanner.
15863083|NCT03937518|Drug|Strontium Ranelate|"Patients received strontium ranelate 2gm (one sachet daily with 50 ml water at bedtime at least 2 h after food), as the compliance of patient assessed by counting number of sachet that patient returns at every visit and safety is assessed by recording adverse effects as blood pressure and heart rate every visit and patients received physiotherapy program in the form of (US therapeutic acoustic radiation and exercise program) 3 times per week for 6 months.
~Ultra sound (US):
~Pulsed ultrasonic waves were delivered at a 1 MHz frequency and at an intensity of 1 watt/ cm2 via a transducer with a diameter of 5 cm and effective radiating area of 3.5 to 5cm² for 9.5 min ("
15863084|NCT03937518|Other|physiotherapy|"Ultra sound (US):
~Pulsed ultrasonic waves were delivered at a 1 MHz frequency and at an intensity of 1 watt/ cm2 via a transducer with a diameter of 5 cm and effective radiating area of 3.5 to 5cm² for 9.5 min (Medserve, England) (Huang et al., 2001). Patients were positioned in a supine position with the affected knee flexed at 90° and the sound head was held stationary over the tibiofemoral joint medial to the patellar tendon to enhance energy penetration into the joint space (White et al., 2007).
~Exercise program:
~The subjects were treated with a group-exercise program composed of a range of motion of all lower limb and 45 min strengthening exercises with 5 min stretching exercises of lower limb muscles 3 times per week under the supervision of the same physiatrist (Fitzgerald and Oatis"
15863085|NCT03937505|Drug|IS-001|intravenous injection of IS-001 investigational drug
15863086|NCT03937505|Drug|No treatment|no drug injection
15863087|NCT03937492|Other|GMI protocol|"This group follow GMI program split in 3 step:
~left/right descrimination
~visual motor imagery
~mirror therapy
~Patients perform this exercises 3 times every day and they have checks in therapy al least twice a week."
15863088|NCT03937492|Other|Standard Rehabilitation Protocol|"This group follow standard rehabilitation protocol, with active and passive motion of upper limb structure, including hand, wrist, elbow, shoulder.
~Patients perform this exercises 3 times every day and they have checks in therapy al least twice a week."
15863089|NCT03937479|Drug|Ensifentrine (formerly RPL554) 0.375 mg twice daily plus placebo, in addition to tiotropium|"Patients will be randomized to receive one of the following treatment arms plus tiotropiuim:
~● RPL554 0.375 mg twice daily The approximate planned duration for each completed patient will be 14 days of run-in and 28 days of treatment with study medication."
15863090|NCT03937479|Drug|Ensifentrine (formerly RPL554) 0.75 mg twice daily plus placebo, in addition to tiotropium|"Patients will be randomized to receive one of the following treatment arms plus tiotropiuim:
~● RPL554 0.75 mg twice daily The approximate planned duration for each completed patient will be 14 days of run-in and 28 days of treatment with study medication."
15863091|NCT03937479|Drug|Ensifentrine (formerly RPL554) 1.5 mg twice daily plus placebo, in addition to tiotropium|"Patients will be randomized to receive one of the following treatment arms plus tiotropiuim:
~● RPL554 1.5 mg twice daily The approximate planned duration for each completed patient will be 14 days of run-in and 28 days of treatment with study medication."
15863092|NCT03937479|Drug|Ensifentrine (formerly RPL554) 3.0 mg twice daily plus placebo, in addition to tiotropium|"Patients will be randomized to receive one of the following treatment arms plus tiotropiuim:
~● RPL554 3.0 mg twice daily The approximate planned duration for each completed patient will be 14 days of run-in and 28 days of treatment with study medication."
15863093|NCT03937479|Drug|Ensifentrine (formerly RPL554) placebo twice daily, in addition to tiotropium|"Patients will be randomized to receive one of the following treatment arms plus tiotropiuim:
~● Placebo twice daily The approximate planned duration for each completed patient will be 14 days of run-in and 28 days of treatment with study medication."
15863094|NCT03937466|Device|Cooling mattress pad|The cooling mattress pad is a commercially available pad designed to be placed between the top of a mattress and bed sheets. It allows for precise temperature regulation in one's bed.
15863541|NCT03933774|Drug|Tretinoin 0.05% cream|Stieva-A Cream 0.05%, 25g, GSK
15863095|NCT03937453|Diagnostic Test|MRI/MRCP|An MRI/MRCP with IV gadolinium contrast with high resolution imaging of the pancreas will be performed annually
15863096|NCT03937440|Drug|Deep neuromuscular block with 'rocunium®'|Rocuronium will be maintained in a arm 1) deep neuromuscular block group or arm 2) moderate neuromuscular block group (control group) according to the assignment. The degree of muscle relaxation is determined by 1 to 2 for post-tetanic count (PTC) in deep neuromuscular group.
15863097|NCT03937440|Drug|Moderate neuromuscular block with 'rocunium®'|Rocuronium will be maintained in a arm 1) deep neuromuscular block group or arm 2) moderate neuromuscular block group (control group) according to the assignment. The degree of muscle relaxation is determined by 1 to 2 for train-of-four (TOF) in moderate neuromuscular group.
15863098|NCT03937414|Device|The OSNA assay|SLN was defatted after SLNB. If the node weighed less than 100mg, the node was only assessed by histology postoperatively. If the node weighed more than 100mg, the node was sliced to equal blocks according to the length of short axis: If the length was less than 4mm, the node was sliced into two blocks along the long axis (a, b). Intraoperatively, the block a and b were tested by TIC, and the block a was prepared for OSNA. Postoperatively, the block b was assessed by histology. If the length was more than 4mm, the node was sliced into four blocks (a, b, c, d). Intraoperatively, all blocks (a, b, c, d) were tested by TIC, and the block a and c were prepared for OSNA.
15863099|NCT03937401|Drug|Oxytocin|Oxytocin infusion during MRI-HIFU treatment
15863100|NCT03937388|Other|Cochlear stimulation strategy including time-fixed gaps|Investigation of the impact of time-fixed gaps (zero-stimulation periods) in the cochlear stimulation strategy on speech performance and hearing quality.
15863101|NCT03937375|Behavioral|High PEEP|Use of high levels of PEEP combined with recruitment maneuvers and low tidal volume ventilation during general anesthesia
15863102|NCT03937375|Behavioral|Low PEEP|Use of low levels of PEEP without recruitment maneuvers and low tidal volume ventilation during general anesthesia
15863103|NCT03937362|Diagnostic Test|First clinical response evaluation (CRE-1)|Consisting of: endoscopy with bite-on-bite biopsies
15863104|NCT03937362|Diagnostic Test|Second clinical response evaluation (CRE-2)|Consisting of: PET-CT, endoscopic bite-on-bite biopsies,EUS with FNA
15863105|NCT03937336|Behavioral|Bike Intervention Group|A 1-month biking-based program. The biking program consists of 4 sessions/month of 120 min at physical education lessons in school, and will focus on promote biking through theory and practice lessons about cycle training skills including on-road training
15863106|NCT03937323|Other|Blood lymphocyte subtypes and serum cytokines|Blood samples will be taken from the patients with biliary pancreatitis and healthy volunteers to perform flow-cytometric analysis and to determine the proinflammatory cytokines
15863107|NCT03937310|Diagnostic Test|Next-generation sequencing of swabs collected during surgery|Traditional swabs for culturing as well as swabs for NGS testing will be collected
15863108|NCT03937297|Behavioral|Six Arts|"The Six Arts intervention is a 24 session, twice a week intervention protocol. There will be four sessions per Art, with specific sequence designed to enhance group dynamic and create harmony. Each session starts with a 15 minutes warm-up exercise, followed by the Six Art theme activity. The program design emphasizes on integrated cognitive, physical, and social activities covering all domains of Six Arts."
15863109|NCT03937297|Behavioral|Cognitive Stimulation Therapy (CST)|The CST to be used involve 24 sessions of theme activities, twice a weekly intervention protocol. It is modified into CST-Hong Kong for activities that are not applicable in Hong Kong Chinese culture (e.g. word games involving alphabets)
15863110|NCT03937297|Behavioral|Usual Care|usual dementia care provided by participating center
15863111|NCT03937284|Other|Patients not treated|
15863112|NCT03937271|Diagnostic Test|Traditional Chinese Medicine pattern|Autoimmune disease (AID) as Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), Rheumatoid Arthritis (RA), Systemic Sclerosis (SSc), Ankylosing spondylitis (AS) for comparing with the Dry eye syndrome (DES) subjects will take the Traditional Chinese Medicine pattern.
15863113|NCT03937271|Diagnostic Test|Traditional Chinese Medicine tongue diagnosis|Autoimmune disease (AID) as Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), Rheumatoid Arthritis (RA), Systemic Sclerosis (SSc), Ankylosing spondylitis (AS) for comparing with the Dry eye syndrome (DES) subjects will take the Traditional Chinese Medicine tongue diagnosis.
15863114|NCT03937271|Diagnostic Test|Traditional Chinese Medicine pulse diagnosis|Autoimmune disease (AID) as Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), Rheumatoid Arthritis (RA), Systemic Sclerosis (SSc), Ankylosing spondylitis (AS) for comparing with the Dry eye syndrome (DES) subjects will take the Traditional Chinese Medicine pulse diagnosis.
15863115|NCT03937271|Diagnostic Test|Heart rate variability|Autoimmune disease (AID) as Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), Rheumatoid Arthritis (RA), Systemic Sclerosis (SSc), Ankylosing spondylitis (AS) for comparing with the Dry eye syndrome (DES) subjects will take the Heart rate variability.
15863116|NCT03937271|Diagnostic Test|Schirmer's test|Autoimmune disease (AID) as Sjögren's syndrome (SJS), Systemic lupus erythematosus (SLE), Rheumatoid Arthritis (RA), Systemic Sclerosis (SSc), Ankylosing spondylitis (AS) for comparing with the Dry eye syndrome (DES) subjects will take the Schirmer's test.
15863117|NCT03937258|Drug|PF-04965842|Participants will be administered a single oral 200 mg dose of PF-04965842 in the morning on Period 1 Day 1 and Period 3 Day 2 under fasted conditions. In Period 2, participants will receive oral 200 mg dose of PF-04965842 once daily (QD) in the morning of Day 1 to Day 4 under fasted conditions
15863118|NCT03937258|Drug|Probenecid|In Period 3, participants will receive probenecid 1000 mg twice daily (BID) in the mornings and evenings of Day 1 to Day 3. On the morning of Period 3 Day 2, after an overnight fast of approximately 8 hours, participants will be administered probenecid 1000 mg. A single 200 mg oral dose of PF 04965842 will be administered approximately 2 hours after the probenecid dose.
15863119|NCT03937232|Behavioral|Cross-Education|Home exercise program + usual care
15863120|NCT03937232|Behavioral|Mirror Visual Feedback|Home exercise program + usual care
15863121|NCT03937232|Other|Usual care|Hand rehabilitation provided by occupational therapists and physiotherapists in a multidisciplinary outpatient setting
15863122|NCT03937219|Drug|Cabozantinib|Specified dose on specified days.
15863123|NCT03937219|Biological|Nivolumab|Specified dose on specified days.
15863124|NCT03937219|Biological|Ipilimumab|Specified dose on specified days.
15863125|NCT03937219|Drug|Cabozantinib-matched placebo|Specified dose on specified days.
15863128|NCT03937193|Diagnostic Test|computerized tomography|abdomen contrast computerized tomography performed for both emergency and elective purposes in HK public hospitals.
15863129|NCT03937180|Behavioral|Blended care|An interactive e-learning programme delivered through a secured web-based platform for patients and general practitioners (GPs), blended with face-to-face contacts between the involved GP and patient.
15863130|NCT03937180|Behavioral|Usual care|"General practitioners offering usual care are expected to follow the Belgian guidelines as described in the most recent online version of Anxiety, stress and sleeping problems A toolbox for general practitioners. or Sleeping pills and sedatives. How to assist your patients in the search for other solutions? which are both available in French and Dutch."
15863131|NCT03937167|Other|Psychotherapy group|Added to standard treatment patients will participate in a standardized group of psychological intervention. 21 sessions with 10 to 12 members closed-ended groups.
15863132|NCT03937154|Drug|Romiplostim|This study is designed to study Romiplostim for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for the treatment of non-small cell lung cancer (NSCLC), ovarian cancer, or breast cancer
15863133|NCT03937154|Drug|Placebo|Placebo comparator
15863134|NCT03937141|Drug|ADU-S100|intratumoral
15863135|NCT03937128|Behavioral|Virtual Reality Job Interview Training|Participants will engage in training related to preforming well during a job interview as well as repeated job interview practice with a virtual hiring manager. Participants will receive feedback and tips on improving skills throughout the training.
15863136|NCT03937128|Behavioral|Services as usual|Study participants will be receiving Vocational Village services as usual that may include but is not limited to vocational skill training, daily living skill training, and social skill training.
15863137|NCT03937115|Device|Active tDCS|2 active tDCS sessions (20 min each, 2 mA) applied to the dlPFC and right motor cortex
15863138|NCT03937115|Device|Sham tDCS|1 sham tDCS session (20 min, 0 mA) applied to the dlPFC
15863139|NCT03937115|Device|Active tDCS|10 tDCS sessions (2 sessions/day for 5 days, 20 mA, 20 min each) applied to the dlPFC
15863140|NCT03937115|Device|Sham tDCS|10 tDCS sessions (2 sessions/day for 5 days, 0 mA, 20 min each) applied to the dlPFC
15863141|NCT03937102|Procedure|cardiac output measure with TTE|All patients included will be simultaneously monitored with transthoracic echocardiography (TTE) and the Physioflow® thoracic electrical bioimpedance device. Cardiac output is measured by the Physioflow® Thoracic Bioimpedance Device and TTE before and after passive leg raising maneuver (PLR)
15863142|NCT03937102|Procedure|cardiac output measure with Physioflow® thoracic electrical bioimpedance|All patients included will be simultaneously monitored with transthoracic echocardiography (TTE) and the Physioflow® thoracic electrical bioimpedance device. Cardiac output is measured by the Physioflow® Thoracic Bioimpedance Device and TTE before and after passive leg raising maneuver (PLR)
15863143|NCT03937089|Other|Data collection|Data collection from medical file
15863144|NCT03937076|Procedure|PECS II block|"Pectoral muscles Nerve block for postsurgical pain, PECS II, based on BUPIVACAINE:
~Pectoral muscles nerve block is a procedure in which local anesthetic is injected into two sites.
~between the major and minor pectoral muscles, in order to anesthetize the lateral and medial nerve. This injection is referred to as PECS I block.
~between the minor pectoral muscle and the anterior serratus muscle, in order to anesthetize the intercostal nerves."
15863145|NCT03937063|Other|Collecting recorded videos of Colonoscopy screening tests|To evaluate, in objective way, the usability of the future alpha version of the APDS device by testing the sensitivity and specificity of its results achieved from running it on the collected recorded videos of Colonoscopy screening tests of the general population.
15863146|NCT03937050|Behavioral|Intervention|"Three film-based components:
~Professional development of doctors and nurses to improve screening and management of GDM. Modules will cover knowledge and relevant clinical guidelines, skills for glucose monitoring and managing medication, specialist obstetric and neonatal care, and lifestyle counselling. These films will be screened 6-monthly at routine professional development meetings.
~Awareness-raising among pregnant women and family members regarding GDM and the importance of healthy lifestyles during pregnancy. The films will be culturally tailored and will be screened in waiting areas of antenatal clinics.
~Structured diabetes self-management education programme for women with GDM to empower them with the necessary knowledge, skills, and confidence to manage GDM successfully. The programme will incorporate behavioural counselling and educational reinforcement. Films will be screened at weekly group sessions and optimised for viewing on mobile devices."
15863147|NCT03937037|Procedure|Saline irrigation|100ml saline irrigation after CBD stone removal with routine ERCP procedure
15863148|NCT03937011|Device|Robotic Suturing of gastric sleeve oversew and vaginal cuff closure|"Robotic Bariatric Sleeve gastrectomy
~Robotic Hysterectomy with or without oophorectomy;"
15863149|NCT03936998|Combination Product|Vancomycin plus VE416 before PNOIT|Vancomycin PO QD x 5 days, followed by VE416 PO QD x 6 weeks followed by PNOIT
15863150|NCT03936998|Combination Product|Vancomycin plus VE416 with PNOIT|Placebo for vancomycin for 5 days and placebo for VE416 x 6 weeks, followed by Vancomycin PO QD x 5 days, followed by VE416 PO QD x 6 weeks with concomitant PNOIT
15863151|NCT03936998|Combination Product|Placebo plus VE416 with PNOIT|Placebo for vancomycin for 5 days and placebo for VE416 x 6 weeks, followed by placebo for vancomycin PO QD x 5 days, followed by VE416 PO QD x 6 weeks with concomitant PNOIT
15863152|NCT03936998|Combination Product|Placebo plus placebo with PNOIT|Placebo for vancomycin for 5 days and placebo for VE416 x 6 weeks, followed by placebo for vancomycin PO QD x 5 days, followed by placebo for VE416 PO QD x 6 weeks with concomitant PNOIT
15863153|NCT03936972|Procedure|ilizarov circular frame and uni-planarexternal fixator|both are types of external fixators, but one is circular frame and other is uni-planar frame
15863154|NCT03936959|Drug|LY3434172|Administered IV
15863155|NCT03936946|Behavioral|Audio Content 1|~30 minute daily audio recordings of content 1 for 28 days
15863156|NCT03936946|Behavioral|Audio Content 2|~30 minute daily audio recordings of content 2 for 28 days
15863157|NCT03936933|Drug|Goserelin acetate 3.6 mg Injection|3.6 mg, Subcutaneously at every 28 days
15863158|NCT03936933|Drug|ZOLADEX® 3.6mg Injection|3.6 mg, Subcutaneously at every 28 days
15863159|NCT03936907|Drug|OWCP Orally Disintegrating Tablet|Medical Grade Cannabis - Orally Disintegrating Tablet (MGC-ODT) containing 5 mg THC and 5 mg CBD
15863160|NCT03936907|Drug|Sativex|Sativex® Oromucosal Spray
15863162|NCT03936868|Procedure|Tendon transfer|flexor carpi radialis transfer in most of patients and boye-transfer in very few
15863163|NCT03936855|Procedure|Direct composite resin|"For both groups: The teeth will have the enamel surface conditioned with 37% phosphoric acid. For the restorative procedure, the same adhesive system will be used
~GROUP ACTIVE COMPARATOR
~Insert resin-modified glass ionomer cement into the pulp chamber;
~Complete the restoration by incremental technique using conventional composite resin in increments of 2mm;
~EXPERIMENTAL GROUP
~Insert Bulk Fill composite inside the pulp chamber to the height of 5 mm;
~Complete the insertion of the Bulk Fill resin to the limit of the caval surface angle in the occlusal"
15863164|NCT03936842|Behavioral|Breast Pain video|An educational video of approximately 10 minutes about breast pain, self-examination and breast awareness will be shown to the participant.
15863165|NCT03936842|Behavioral|Semi-structure interviews|A semi-structured, face-to-face interview will be then undertaken. The principles of Grounded Theory will be used to guide the interview. All of the interviews will be recorded and transcribed securely, only referencing the patient according to their study number. Their name and hospital number will not be used.
15863167|NCT03936816|Other|GBS vaginal double swab|The vaginal double swab will be assessed by two different lab tests: The first one for GBS culture on selective media after enrichment of 16h and the second swab by the Cepheid Xpert GBS Assay performed on the GeneXpert Dx system which is a qualitative in vitro diagnostic test designed to detect GBS DNA from vaginal swab specimens, using fully automated real-time polymerase chain reaction (PCR).
15863168|NCT03936803|Behavioral|aerobic interval training exercise .|Its consisted of cycle ergometer training, 3 days a week for 6 weeks. Aerobic interval training consisted of ( 8 )minutes warm-up, followed by 4 times of 4-minute intervals with HR at 85% of sub maximum HR, with active pauses of 3 minutes of walking at 60% of sub maximum HR. The exercise session was terminated by 5 minutes cool-down
15863169|NCT03936803|Device|electro acupuncture|"electroacupuncture (EA) of (2 Hz, 4 mA) was applied at points of:liver 3 LR3,liver 14 LR 14, gall bladder 34 (GB 34) and stomach 36 (ST36) .
~Duration of the session was 15 min / each, three sessions per week for six weeks"
15863170|NCT03936790|Other|Ropivacaine|In case of successful spinal anaesthesia, the dose of spinally administered ropivacaine will decrease by 0.375 mg for the next participant.In case of unsuccessful spinal anaesthesia, the dose of spinally administered ropivacaine will increase by 0.375 mg for the next participant.
15863171|NCT03936790|Other|Fentanyl|A fix dose of fentanyl (15 mcg) will be co-administered spinally to all participants.
15863172|NCT03936777|Drug|ZX008 (Fenfluramine Hydrochloride)|Fenfluramine hydrochloride provided in a concentration of 2.5 mg/mL.
15863173|NCT03936764|Other|Preoperative Pulmonary Rehabilitation|"Each prehabilitation session will last approximately 90 minutes and will include:
~Endurance training at the ventilatory threshold, determined according to the initial CPET. The first session will last for 15 to 20 minutes then increase by 5 minutes each session to reach 45 minutes in total (including a 5-minute warm-up and 5 minutes of active recovery). The intensity will then increase by 5 or 10 W, as could be tolerated;
~Peripheral muscle strengthening at 60% to 70% of the 1-repetition maximum of 3 main components (quadriceps press, whole-leg extension, and upper limb pull down). Three sets of 12 movements will carry out for each exercise and the load will increase weekly as tolerated;
~Inspiratory muscle training using a threshold calibrated to at least 30% of the MIP. Patients will be encouraged to carry out 15 minutes of independent training daily and to increase the resistance regularly.
~Education to bronchial drainage techniques as well as directed coughing."
15863174|NCT03936751|Device|CPAP|This is the standard treatment for OSA.
15863175|NCT03936751|Device|Nasal Strips|Nasal strips were commercially available in the market for supposing treat snoring and sleep apnea but no proof that this is true. Our group previously validated nasal strips as an interesting placebo.
15863176|NCT03936725|Other|1 year phone call : data collection|"Included patients are contacted by telephone at 12 months after discharge. The investigators explain to the patient that this call is in the same context as a regular follow-up rehabilitation consultation and that the data collected will also be part of a study to evaluate and improve the program in which they participated. The interview will be transcribed in writing in their computerized and secure medical file. During this 20-minute telephone conversation, the patient answers a number of questions via a standardized questionnaire, in order to gather the various criteria for judgment.
~If patients do not answer the first call, a phone message will be left and they will be contacted again up to 2 times. Patients who do not respond to 3 calls will be considered lost to follow-up."
15863177|NCT03936712|Dietary Supplement|Energy Drink|Each participant visited the laboratory for two formal test sessions, drinking a caffeine-containing ED (RB) and a caffeine and taurine free beverage drink (PL). All sessions were arranged in the early evening hours to avoid any time of day effects. The two definitive test sessions were separated by an interval of seven days to allow sufficient recovery between tests and to ensure caffeine washout. To avoid identification, two opaque and unmarked cans of RB or PL were ingested by each participant (i.e., 500 mL) in the presence of a researcher. The two drinks were similar in volume, texture, and appearance. One can of RB drink (i.e., 250ml) contained 80 mg of caffeine, 1 g of taurine, 27 g of carbohydrates, 0.6 g of protein, 5 mg vitamin B6 and 487 kJ of energy.
15863178|NCT03936712|Dietary Supplement|Placebo Drink|The PL drink was prepared by an agri-food engineer; it did not contain any caffeine or taurine, but comprised carbonated water, carbohydrates, citric acid lemon juice reconstituted from concentrate (1 %), supplemented by flavorings, of sodium citrate, acesulfame K, sucralose, potassium sorbate and RB (a flavoring that contains propylene glycol E1520 (0.23 mL).
15863179|NCT03936699|Device|Transcutaneous Nerve Stimulator (TENS)|"The Elira wearable patch system is a Radio Frequency (RF) coupled, wearable transcutaneous electrical nerve stimulator (TENS) device controlled via Bluetooth by a smart phone unit running a custom application which directs therapy from the patch within safe limits set by a clinician and also includes a weight loss diary.
~Behavioral: Diet & Exercise Subjects to be instructed on a healthy 1200 calorie diet."
15863180|NCT03936699|Behavioral|Diet & Exercise|Subjects to be instructed on a healthy 1200 calorie diet.
15863181|NCT03936686|Other|Survey tool to assess CVD risk factor knowledge|The survey tool was used to assess the participant's knowledge level and their previous methods of education regarding cardiovascular disease risk factors.
15863183|NCT03936660|Other|Intense Education Intervention|Intervention will involve guideline-based care education.
15863184|NCT03936647|Procedure|surgical clipping, simple coiling, high-porosity stenting with/ without coiling, intra-arterial flow diversion with/ without coiling|Treatment may include the most appropriate amongst surgical clipping, simple coiling, high-porosity stenting with or without coiling, and intra-arterial flow diversion with or without coiling, which will be predetermined by the treating physician prior to randomization.
15863185|NCT03936647|Device|WEB embolization device|WEB embolization device
15863186|NCT03936621|Drug|Omega 3 fatty acid|To evaluate the efficacy of 3.6 g omega 3 fatty acid supplements (2.4 g EPA + 1.2 g DHA)/day for 6 months versus no treatment at reducing the level of C-reactive protein (CRP) in ever smokers at high risk of lung cancer. The primary endpoint of the study is reduction of CRP.
15863187|NCT03936608|Device|Programming individualized RV-LV pacing offset to optimize ECG|After CRT device implant, participants will undergo physiologic evaluations at various (up to 10 or more) RV-LV offset settings including ECGs. The RV-LV offset that optimizes the paced QRS morphology on ECG will be programmed.
15863188|NCT03936608|Device|Nominally programming CRT device without RV-LV offset|After CRT device implant, participants will undergo physiologic evaluations at various (up to 10 or more) RV-LV offset settings including ECGs. Nominal standard-of-care CRT programming with no RV-LV offset will be programmed.
15863189|NCT03936595|Other|Core exercises protocol|"Participants will perform:
~Squats, 4 sets of 5 repetitions at 60% 1RM
~Deadlifts, 4 sets of 5 repetitions at 60% 1RM
~Lunges, 4 sets of 5 repetitions at 60% 1RM
~Step ups, 4 sets of 5 repetitions at 60% 1RM"
15863190|NCT03936595|Other|Structural exercises protocol|"Participants will perform:
~Snatch, 4 sets of 5 repetitions at 60% 1RM
~Hang clean, 4 sets of 5 repetitions at 60% 1RM
~Push jerk, 4 sets of 5 repetitions at 60% 1RM
~Split push jerk, 4 sets of 5 repetitions at 60% 1RM"
15863191|NCT03936595|Other|Accentuated eccentric load exercises protocol|"Participants will perform:
~Deadlifts - squat jump, 4 sets of 5 repetitions at 30% body mass (BM)
~Step down - squat jump, 4 sets of 5 repetitions at 30% BM
~Step down - lunges, 4 sets of 5 repetitions at 30% BM
~Hip thrusts, 4 sets of 5 repetitions at 30% BM"
15863192|NCT03936595|Other|Control condition|Participants will perform all the measurements that are comprised in the experimental conditions without performing any exercise protocol
15863193|NCT03936582|Behavioral|Treatment|information already included in arm/group descriptions
15863194|NCT03936569|Drug|Marketed Toothpaste|Marketed stannous fluoride (0.454%) toothpaste
15863195|NCT03936569|Drug|Marketed Cavity Protection Toothpaste|Marketed sodium monofluorophosphate (0.76 %) toothpaste
15863196|NCT03936556|Drug|Marketed toothpaste|Marketed stannous fluoride (0.454%) toothpaste
15863197|NCT03936556|Drug|Marketed Cavity Protection Toothpaste|Marketed sodium monofluorophosphate (0.76 %) toothpaste
15863198|NCT03936543|Other|Position change|Different position during central line catheterization
15863199|NCT03936543|Other|Conventional position|Conventional position during central line catheterization
15863200|NCT03936517|Drug|Prednisolone|Low dose prednisolone for the treatment of adrenal insufficiency. Usually administered once daily
15863201|NCT03936517|Drug|Hydrocortisone|Standard regimens of hydrocortisone for the treatment of adrenal insufficiency. Usually administered thrice daily.
15863202|NCT03936504|Behavioral|Control Group ：conventional exercise rehabilitation programs (CERP)|The participants in the control group will receive a conventional exercise rehabilitation programs (CERP) thrice a week for 12 weeks. Each training session lasts for 60 minutes, including ordinary warm-up exercises (10 minutes), aerobic activity (30 minutes), resistive exercise (10 minutes), and cool-down exercises(10 minutes). Each training session includes:(1) an active warm-up including arm-swinging, gentle stretches of the neck, shoulders, spine, arms, legs and so on;(2) aerobic activity mainly including aerobic radio exercise;(3) resistive exercise mainly including elastic belt exercise;(4) cool-down session involving active and static stretching exercises with primary body movements.
15863203|NCT03936504|Behavioral|Experimental Group ：Tai Chi cardiac rehabilitation program (TCCRP)|Participants perform Tai Chi cardiac rehabilitation program(TCCRP) thrice a week for 12 weeks. Each training session lasts for 60 minutes, including Tai Chi warm-up exercises(10 minutes), Bafa Wubu of Tai Chi(30 minutes), Tai-Chi in conjunction with X-light-band resistance exercise(10 minutes), and Tai Chi cool-down exercises(10 minutes). All participants are encouraged to practice Tai Chi followed the instructional video until finishing 12-week exercise.
15863204|NCT03936491|Drug|Methylphenidate|Methylphenidate is a central nervous system stimulant used for the therapy of attention deficit disorder and narcolepsy.
15863205|NCT03936491|Drug|Atomoxetine|Atomoxetine is a medication used to treat attention deficit hyperactivity disorder (ADHD).[6] Use is only recommended in those who are at least six years old.[6] It is taken by mouth.[6]
15863207|NCT03936465|Drug|BMS-986158|BMS-986158 belongs to a group of drugs called Bromodomain (BRD) and Extra-Terminal Domain (BET) inhibitors. These drugs block proteins that are important in reading DNA, which is a process important for cancer cells.
15863208|NCT03936452|Drug|Sintilimab|Sintilimab 200mg ivdrip D1 Anlotinib 12mg po D1-14 Peg-aspargase 2500U/m2 im D1 combined with radiotherapy
15863209|NCT03936426|Drug|Cu-64 SARTATE and Cu-67 SARTATE|Cu-64 SARTATE diagnostic drug Cu-67 SARTATE therapy drug
15863210|NCT03936413|Device|Bay Labs EchoGPS Echcoardiogram|An echocardiogram will be performed in this arm using the Bay Labs EchoGPS. The Bay Labs EchoGPS system is an ultrasound system which uses the techniques of computer vision to analyze echocardiography images in real time. It then provides feedback to the user to optimize the images, and once they meet a specific level of quality it automatically records the images.
15863211|NCT03936413|Device|Native Terason Echocardiogram|An echocardiogram will be performed in this arm using a native Terason echocardiography system. This system will not have any artificial intelligence assistance in image optimization or selection.
15863212|NCT03936400|Behavioral|Couple-based intervention and and evaluation of effectiveness in increasing adjustment of sexuality and intimacy|Three face-to-face therapeutic conversations and an optional web-based evidence based information (about sexual consequences of cancer treatment)
15863398|NCT03934931|Other|Streamlined weekly DOT visits|Streamlined, weekly DOT clinic visits to have health worker observe medication ingestion and screen for side effects
15863213|NCT03936387|Drug|Ropivacaine|Erector spinae blocks: T4/5 transverse process is identified with the ultrasound transducer in a parasagittal orientation; the needle tip is advanced until it contacts the transverse process, just below the erector spinae muscle complex; the erector spinae muscle is visualized to be elevated up off of the transverse process with normal saline injection. Following a bolus injection of 2ml/kg of 0.2% ropivacaine, a catheter is threaded into the space occupied by the local anesthetic bolus. Repeated on contralateral side.
15863214|NCT03936374|Drug|BMS-986205|Participants will receive BMS-986205 on Days 1 and 15
15863215|NCT03936374|Drug|omeprazole|Participants will receive omeprazole on Days 10 to 15
15863216|NCT03936361|Drug|Statins|Statin drugs (already prescribed) at ICH onset will be either continued or discontinued by the participants following qualifying ICH
15863217|NCT03936348|Device|Exercise training program with and without FB|"Participants carried out a supervised RP for 8 weeks, 3 days per week. The training sessions lasted 60 minutes and included a warning up phase, the main phase and a recovery phase. After each session, Borg's perceived exertion was measured. The Rehabilitation Program (RP) included aerobic exercise on cycle ergometer and on treadmill (progressing since 10' to 30' and since 40 to 75% of the reserve heart rate (RHR) or 6-7 score based on Borg's perceived exertion), strengthening of lower and upper limb muscles groups, breathing exercises (pursed lip breathing, diaphragmatic and abdominal breathing and diaphragmatic mobility) and finally stretching exercises.
~In the FB group, for restricted nasal breathing, at the beginning of the training program, the small size device was used (4 mm). The size of the device was progressively increasing according to the patient adaptation to the 5 or 6 mm device, depending on the score on Borg's perceived exertion scale."
15863218|NCT03936335|Drug|dupilumab|No study drug will be administered. This study is based on an analysis of automated medical and prescription claims, supplemented by information abstracted from the medical record.
15863219|NCT03936322|Device|Minimally invasive fetoscopic repair of MMC|Uses a technique to open your belly (skin, muscles and abdomen) without opening the uterus, except for a small puncture, to repair the fetal spina bifida defect during the second trimester of pregnancy.
15863220|NCT03936309|Other|Scar Deactivation Surface Release Technique protocol|▪ Alternating placement of Spring Ten (0.30x40 mm) acupuncture needles to surround scar left in place for a treatment duration of 20 minutes. Needles will be placed at intervals of 1cm to 1.5 cm and will surround the scar with a maximum of 20 needles per treatment.
15863221|NCT03936309|Other|Scar Infiltration with 0.25-1% Lidocaine|▪ Will consist of calculation of 3 mg/kg dose of 0.5-1% Lidocaine and a dermal followed by subcutaneous injection using 1.5 inch 25 G needle and syringe appropriate for volume based on calculated dose.
15863222|NCT03936309|Other|Physical therapy|▪ Will be a referral to physical therapy specifying McKenzie protocol treatment for the presenting complaint. The McKenzie protocol is a form of standard of care physical therapy in which the physical therapist tries to find a cause and effect relationship between the positions the patient usually assumes while sitting, standing, or moving, and the location of pain because of those positions or activities. The therapeutic approach requires a patient to move through a series of activities and test movement to gauge the patient's pain response. The approach then uses that information to develop an exercise program designed to centralize or alleviate the pain.
15863223|NCT03936296|Procedure|mpMR guided MR-US fusion transrectal prostate biopsy|mpMR images will be loaded to US fusion platform and registration of the will be performed. Suspicious lesions on MR which have PIRADS score 3 and above are targeted. Additional 2-4 cores biopsies will be taken them
15863224|NCT03936296|Procedure|12 core standard transrectal prostate biopsy|Under the guidance of transrectal ultrasonography, 12 core biopsies taken from apex, apex lateral, mid, mid lateral, base and base lateral of right and left prostate lobe
15863225|NCT03936283|Behavioral|Intervention|The goal of the intervention is to help women increase their minutes of moderate-to-vigorous physical activity and to increase their knowledge of the IOM gestational weight gain guidelines. The lifestyle intervention will be delivered through telephone counseling sessions with a study dietician trained in motivational interviewing techniques, as well as through technology-based tools, automated text messages and core lifestyle intervention sessions.
15863226|NCT03936270|Drug|Palbociclib 125mg|The Palbociclib capsules supplied for this study contains 75 mg, 100 mg or 125 mg of Palbociclib. It must be taken orally 125 mg once daily for 21 consecutive days followed by 7 days off treatment (Schedule 3/1) to comprise a complete cycle of 28 days.
15863227|NCT03936270|Drug|Letrozole 2.5mg|Letrozole will be supplied as a 2.5 mg film-coated tablet. It must be taken at the recommended dose of 2.5 mg once daily.
15863228|NCT03936257|Other|Breastfeeding|Infants were breastfed during 3 months minimum. Data on growth and tolerance were collected. 10 out of 40 infants take a blood test to metabolome analysis
15863229|NCT03936257|Other|Conventional BIO Infant formula|Infant were fed during 6 months with a conventional BIO infant formula. Data on growth and tolerance were collected. 10 out of 40 infants take a blood test to metabolome analysis
15863230|NCT03936257|Other|TrueGreen BIO infant formula|Infant were fed during 6 months with the TrueGreen BIO infant formula. Data on growth and tolerance were collected. 10 out of 40 infants take a blood test to metabolome analysis
15863231|NCT03936244|Device|Transurethral Resection of the Prostate (TURP)|Randomized allocation to M-TURP or PK-TURP
15863232|NCT03936231|Other|NO Intervention|"Given the observational nature of this study, we consider that no intervention is required.
~Participation in concomitant studies: given the observational condition of this study, patiens that are included in other observational and/or experimental researches, can be included in the current study."
15863233|NCT03936218|Drug|Inj. Goserelin (Test) Subcutaneously|10.8 mg, subcutaneously at every 3 month
15863234|NCT03936218|Drug|Inj. Zoladex (Reference) Subcutaneously|10.8 mg, Subcutaneously at every 3 month
15863235|NCT03936205|Drug|Dexmedetomidine|Patients allocated to this group receive a combination of Morphine and Dexmedetomidine
15863236|NCT03936192|Drug|glucosamine sulphate 1500mg and meloxicam 15mg|glucosamine sulphate 1500mg plus meloxicam 15mg, manufactured by Eurofarma Laboratories S.A., administered once a day for 12 weeks.
15863237|NCT03936192|Drug|Glucosamine sulfate 1500mg and chondroitin sulfate 1200mg|Glucosamine sulfate 1500mg and chondroitin sulfate 1200mg, manufactured by Zodiac Pharmaceutical Products S.A. (Condroflex®)
15863238|NCT03936192|Drug|Placebos|Placebo administered once daily for 12 weeks.
15863505|NCT03934203|Drug|Placebo matching to BI 409306|Film-coated tablet
15863239|NCT03936179|Radiation|high dose radiation therapy with concurrent chemotherapy|standard dose of 50 Gy concurrent weekly with paclitaxel (45 mg/m2) and carboplatin (area under curve 1.5 ), immediately followed by hyperfractionated radiotherapy boost of 36 Gy in 30 fractions of 1.2 Gy to residual metabolic disease as defined by PET/CT
15863240|NCT03936166|Drug|CRN01941 Oral Solution|Investigational drug
15863241|NCT03936166|Drug|CRN01941 Oral Capsule|Investigational drug
15863242|NCT03936166|Drug|Placebo Oral Solution|Placebo
15863243|NCT03936166|Drug|Placebo Oral Capsule|Placebo
15863244|NCT03936153|Drug|abexinostat|abexinostat tablet
15863245|NCT03936140|Drug|Inhaled iloprost|Study drug was inhaled to ventilated lung through a nebulized system in inspiratory limb after one-lung ventilation in the lateral decubitus position.
15863246|NCT03936140|Drug|Distilled water|Study drug was inhaled to ventilated lung through a nebulized system in inspiratory limb after one-lung ventilation in the lateral decubitus position.
15863247|NCT03936127|Procedure|Ultrasound (US) Targeted Fusion Biopsy|Ultrasound (US) Targeted Fusion Biopsy
15863248|NCT03936114|Behavioral|SMART|SMART program mindfulness training program
15863249|NCT03936101|Diagnostic Test|Prenatal Genomic Sequencing|Whole genome sequencing (which initially will be masked and reported as exome only)
15863250|NCT03936088|Device|"Intervention -- Headspace mindfulness application"|"Patients will be provided with a pre-paid 12-week subscription to the mindfulness application, and provided an in-person demonstration on how to use it, and the subscription license code will be recorded for the purposes of tracking use after the conclusion of the study. The intervention group will be asked to use the mindfulness app 10 minutes per day/5 days per week. To standardize Pack usage across all participants, users will be asked to complete the Headspace Essentials, Pain Management, and Physical Health Session Packs."
15863251|NCT03936088|Device|"Control -- My Water Balance application"|My Water Balance calculates an individual's recommended daily water requirements and assists users in tracking their daily fluid intake. The control group will be asked to log their water intake for the duration of the study, with requested use of 5 days per week to create an equal control. This application is free to download and use. There are options for in-app purchases and application upgrades, though users will be advised against doing so. Information logged in the application may be stored on a third party server; however, no application data will be extracted by the study team. Application use will be reported via weekly surveys, alone.
15863252|NCT03936075|Behavioral|the Guided Imagery and Music method|the method involves listening to the music while describing the experience to the therapist, any visual imagery that is evoked by the music, emotions, body sensations, thoughts or memories. after the music listening session, there is discussion upon making meaning of the experience and finding resources as potential coping skills
15863253|NCT03936075|Behavioral|standard care and verbal counselling|the participants receive their usual cancer treatment and two individual counselling sessions
15863254|NCT03936062|Drug|Sitagliptin|Sitagliptin dispensing claim is used as the exposure
15863255|NCT03936062|Drug|Sulfonylurea|2nd generation sulfonylurea dispensing claim is used as the reference
15863256|NCT03936049|Drug|Liraglutide|Liraglutide dispensing claim is used as the exposure group
15863257|NCT03936049|Drug|DPP-4 inhibitor|DPP-4 inhibitor dispensing claim is used as the reference group
15863258|NCT03936036|Drug|Linagliptin|Linagliptin dispensing claim is used as the exposure
15863259|NCT03936036|Drug|Sulfonylurea|2nd generation sulfonylurea dispensing claim is used as the reference
15863260|NCT03936023|Drug|Saxagliptin|Saxagliptin dispensing claim is the exposure
15863261|NCT03936023|Drug|Sulfonylurea|2nd generation sulfonylurea dispensing claim is used as the reference
15863262|NCT03936010|Drug|Canagliflozin|Canagliflozin dispensing claim is exposure
15863263|NCT03936010|Drug|DPP-4 inhibitor|DPP4 inhibitor dispensing claim is reference
15863264|NCT03935997|Other|Strengthening a Palliative Approach in Long-Term Care (SPA-LTC) Program|"Our team will work with long-term care homes in the study to implement the Strengthening a Palliative Approach in Long Term Care (SPA-LTC) which consists of the following core, evidence-informed components:
~Interdisciplinary Champion Teams (to provide leadership and support implementation); Palliative Care Education (including illness trajectory pamphlets); Comfort Care Rounds with staff (for capacity building and reflection); Prognostic Tools to trigger end-of-life discussions; Palliative Care Conferences with families and residents; Bereavement Pamphlets; and Post-Bereavement Follow-Up for families, and staff."
15863265|NCT03935984|Drug|Calcitonin|Treatment with calcitonin to lower high calcium levels prior to reimaging exam
15863266|NCT03935971|Drug|Dupilumab|See arm/group description
15863267|NCT03935958|Dietary Supplement|Curcumin|Patients will receive curcumin (Longvida) 2000 mg, once a day, for 12 months
15863268|NCT03935958|Other|Placebo|Patients will receive placebo capsule identical in appearance and taste to the supplement, for 12 months
15863269|NCT03935945|Behavioral|Personalized Feedback Intervention|Participants in the intervention group will receive a computerized personalized feedback intervention (PFI) lasting approximately 20-30 minutes. PFI highlights discrepancies between one's own drinking and typical drinking; reframes use in terms of personal, social, financial, and health consequences; and, offers strategies for reducing alcohol use. The feedback is non-confrontational in tone, seeks to increase motivation to reduce drinking and is based on the information provided during the baseline assessment
15863270|NCT03935932|Device|nasal delivery of heated and humidified air|Subjects will receive nasal delivery of heated and humidified air (plus oxygen if needed) at 30 liters/minute from the Fisher and Paykel myAirvo2 heater/humidifier using an Optiflow nasal cannula.
15863271|NCT03935906|Other|Reach Pathway|Trial of outreach nurse offering point-of-care Hepatitis C (HCV) testing to opiate substitution therapy patients in community pharmacies, which is hypothesised to improve number of patients tested and cured of HCV.
15863272|NCT03935906|Other|Education-only Pathway|Trial of community pharmacists advising opiate substitution therapy patients to attend a local blood-borne virus clinic to be tested for Hepatitis C by a specialist nurse, which represents the standard care pathway for HCV patients in the countries included in the study.
15863301|NCT03935646|Drug|Adderall IR 10mg|At one of the experimental appointments, participants will be administered a stimulant medication. Following a wait period, the participants will complete executive functioning tasks of working memory and sustained attention.
15863302|NCT03935646|Drug|Placebo|Placebo
15863273|NCT03935893|Biological|Tumor Infiltrating Lymphocytes (TIL)|TIL are to be infused intravenously through a central vein catheter over 20-30 minutes followed by Aldesleukin, administered at a dose of 600,000 IU/kg (based on total body weight) as an intravenous bolus over a 15-minute period approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to a maximum of 6 doses.
15863274|NCT03935893|Drug|Fludarabine + Cyclophosphamide combination|Preparative lymphocyte depleting (immunosuppressive) combination regimen consisting of fludarabine and cyclophosphamide administered prior to TIL infusion.
15863275|NCT03935880|Device|Cartiva Implant|Cartiva hemiarthroplasty: The procedure starts with a small incision over the top of the 1st MTP joint. The joint is exposed. Bone spurs on the metatarsal and proximal phalanx are resected, leaving approximately 2 mm of surrounding bone on the metatarsal head. A guide pin is placed within the metatarsal and a drill is then used to create a site for the implant. The implant is then placed using the implant introducer. The incision is then closed and a sterile dressing is placed.
15863276|NCT03935880|Procedure|Cheilectomy|Cheilectomy: A small incision is made over the top of the 1st MTP joint. The joint is exposed. Bone spurs on the metatarsal and proximal phalanx are resected. The top of the metatarsal head is then cut with a saggital saw. Additional bone spurs are resected. The incision is closed and a sterile dressing is placed.
15863277|NCT03935867|Behavioral|C-PROFET|An expansion of the evidence-based, multi-factorial, fall prevention program PROFET (Prevention Of Falls in the Elderly Trial), developed for older adults who experienced a fall-related injury, to an at risk community-dwelling population who have not sustained a fall-related injury requiring medical intervention.
15863278|NCT03935854|Other|LCHF, Ketogenic Diet|Low Carbohydrate, Moderate Protein, High Fat Ketogenic Dietary Intervention 16 weeks
15863279|NCT03935841|Dietary Supplement|3-OHB salt (NaCl)|36 gram 3-OHB salt diluted in 500 ml sterile water
15863280|NCT03935828|Drug|Oral versus topical antibioitics|Previously described in two arms
15863281|NCT03935815|Drug|Ropivacaine injection|30 mL of 0.25% ropivacaine will be administered on both the right and left sides with a 20 gauge, 4 inch ultrasound needle using a SonoSite ultrasound machine with a linear transducer probe. The tip of the ultrasound needle will be placed posterior to the quadratus lumborum muscle (QL2) made in the plane between the quadratus lumborum muscle and thoracolumbar fascia.
15863282|NCT03935815|Procedure|Sham treatment|A sham procedure with a superficial 22 gauge needle stick will be performed without injectate.
15863283|NCT03935802|Radiation|radiation|
15863284|NCT03935789|Behavioral|BLAST|12-week self-guided intervention using a web-based platform
15863285|NCT03935776|Behavioral|Risk Factors Modification Programme|12- week supervised risk factor modification programme derived from the Euroaction study standards
15863286|NCT03935776|Behavioral|Standard Healthcare|Patients are advised to adjust lifestyle without the support of the structured supervised programme
15863287|NCT03935763|Other|observational disease study|observation of routine clinical practices in mCRC
15863288|NCT03935750|Procedure|Anterior cruciate ligament reconstruction (ACLR)|All participants will undergo an anatomic ACLR with either a BPTB or QT autograft, as randomized.
15863289|NCT03935750|Procedure|Lateral extra-articular tenodesis (LET)|Participants randomized to the BPTB or QT arms will be randomized a second time to a LET procedure or no additional surgery.
15863290|NCT03935737|Diagnostic Test|Full Dose Chest X-Ray|Full dose X ray at Day 1
15863291|NCT03935737|Diagnostic Test|Low Dose Chest X-Ray|Low dose X ray within 3 months from full dose
15863292|NCT03935724|Biological|Neuro-Cells|Neuro-Cells is an autologous fresh stem cells containing product which modulates the secondary inflammation following a TSCI, reduces apoptosis (cell death) in the injured spinal cord, reduces scar tissue formation in the damaged spinal cord and creates a cell regenerative environment in the injured spinal cord.
15863293|NCT03935698|Other|Physiotherapy|
15863294|NCT03935685|Drug|Mirtazapine (Remeron)|Eligible patients should start Mirtazapine 15mg and stay there unless not tolerated, If there is no improvement in nausea dose can be increased to 30 mg and respectively 45 mg, 4 days apart. If excessive sleep, dose can be doubled. Patients should not take tryptophan while they are part of the study.
15863295|NCT03935672|Procedure|PET-CT scans|"Patients will have three scans during the trial.
~The 1st scan (prePET) is a baseline diagnostic scan. The patient is in a thermoplastic shell and PET CT will be used by to define a bGTV_P. bGTV_P will then be used as an adjunct to help us delineate the GTV_P.
~The 2nd scan (iPET) takes place following 2 weeks (10 fractions) of chemo-radiotherapy. The patient is in a thermoplastic shell and the PET CT will be used to delineate the remaining avid disease (bGTV_iP).
~The 3rd scan takes place 3 months following the last dose of radiotherapy. It will be used to ascertain whether any avid disease remains and may inform the need for further treatment."
15863296|NCT03935672|Procedure|Outlining the biological GTVs (bGTV_P and bGTV_iP)|The biological GTVs (bGTV_P and bGTV_iP) will be automatically delineated by ATLAAS and verified manually by a nuclear medicine physician and a clinical oncologist. It will consist of the high FDG uptake volume based on visual assessment whilst using suitable windowing levels. Any differences in contouring will be settled either by the two doctors reaching a consensus or by a third doctor if differences between the first two cannot be resolved.
15863297|NCT03935672|Procedure|Blood samples for cell-free DNA analysis|In order to contribute to our understanding of how disease processes may be monitored in a less invasive and less morbid manner, we will be collecting blood and saliva samples prior to, during, and after the radical treatment of OPSCC in PEARL, to see if there is correlation with disease status and FDG-PET-CT response.
15863298|NCT03935672|Procedure|Salivary samples for cell-free DNA analysis|In order to contribute to our understanding of how disease processes may be monitored in a less invasive and less morbid manner, we will be collecting blood and saliva samples prior to, during, and after the radical treatment of OPSCC in PEARL, to see if there is correlation with disease status and FDG-PET-CT response.
15863299|NCT03935659|Device|Negative Pressure Pressure Wound Therapy|Investigators will be using a Negative Pressure Wound Therapy Powered Suction Pump on primarily closed groin wounds after open common femoral artery exposure, The Negative pressure dressing will be applied in a sterile fashion in the operating room. The negative pressure dressing will be removed at day 5 postoperatively, or at discharge, whichever occurs first.
15863300|NCT03935659|Procedure|Standard Wound Care|Standard sterile gauze coverage of the primarily closed groin wound.
15863303|NCT03935633|Drug|CN128 Tablets|Iron chelator， oral tablets
15863304|NCT03935620|Behavioral|Enhanced Milieu teaching|"Enhanced Milieu Teaching (EMT) an evidence-based, naturalistic language intervention that has been optimized to address the specific language and communication deficits associated with DS. EMT is a parent-implemented intervention that involves home-visits during which clinicians teach parents to support their child learning language during typical parent-child interactions at home (play with toys, music, book reading, and snack time). Clinicians follow an evidence-based instructional framework called Teach-Model-Coach-Review to teach parents language support strategies."
15863305|NCT03935607|Diagnostic Test|Transvaginal sonography|Transvaginal sonography for the evaluation of an amniotic fluid pocket preceding the fetal presenting part.
15863306|NCT03935594|Biological|PRP Injection|1mL platelet rich plasma will be injected into each 1cm x 1cm area of scar tissue of the experimental half of the scar.
15863307|NCT03935594|Drug|Saline Injection|1mL NS will be injected into each 1cm x 1cm area of scar tissue of the control half of the scar.
15863308|NCT03935581|Device|ExAblate|Auto Focusing (AF) echo imaging
15863309|NCT03935568|Drug|PU-AD|3 cohorts receiving a single oral dose of PU-AD at one time.
15863310|NCT03935568|Drug|Placebo|3 cohorts receiving a single oral dose of Placebo at one time
15863311|NCT03935568|Drug|Placebo|2 cohorts receiving multiple oral dose of Placebo at one time
15863312|NCT03935568|Drug|PU-AD|2 cohorts receiving multiple oral dose of PU-AD at one time
15863313|NCT03935555|Drug|PU-H71|PU-H71 is a synthetic purine-scaffold stress chaperome inhibitor, which specifically targets HSP90 in the tumor-specific epichaperome
15863314|NCT03935529|Behavioral|Behavioural Activation|"Participants will receive five sessions of Behavioural Activation. Behavioural Activation uses strategies such as activity scheduling, mastery and pleasure ratings, and graded task assignments to change a participant's perception of specific situations.
~Behavioural Activation is based on the behavioural model of depression (Lewinsohn & Shaffer, 1971). Specifically, that depression is a result of reduced positive reinforcement, particularly in social relationships. Behavioural Activation aims to reduce depressive symptoms by implementing a schedule of positive reinforcement by altering a participant's behaviour and/or their environment. As, in certain environmental contexts, behaviours that reduce depression will continue to occur through reinforcement and those that increase depression will decrease over time (Roane, Fisher, & Carr, 2016).
~Behavioural Activation has been shown to be an effective intervention for the reduction of depressed mood."
15863315|NCT03935516|Other|Cast|The use of plaster and/or fiberglass for casting of subject arm.
15863316|NCT03935503|Procedure|TEP|By making a 2 cm incision under the umbilicus, skin subcutaneous tissues are passed through blunt dissections and the anterior fascia of the rectus muscle is exposed. An anterior rectus sheath with a scalpel is performed with a 15 mm incision. The rectus muscle is laterally lateralized and the balloon trocar or laparoscope itself is advanced from the midline to the symphysis pubis via the posterior rectus sheath. After the peritoneal cavity is dissected, a low pressure pneumoperitone 10 mm Hasson trocar or another 10 mm balloon caged trocar is advanced through the subumblic incision. 9-11 mmHg low pressure pneumoperitoneum is created to prevent the development of subcutaneous emphysema. For proper imaging, the patient should have complete muscle relaxation. The patient is given a position towards the light trandelenburg and non-hernia side.
15863317|NCT03935503|Procedure|Lichtenstein repair|"After the inguinal incision, the skin and subcutaneous camper and scarpa tissues are passed and the external oblique aponeurosis is dissected in the direction of the extension of the fibers and the medial lateral edge of the rectus is dissected to the lateral inguinal ligament, then the spermatic cord is released and suspended.The spermatic cord is separated from the inguinal canal.
~In indirect hernias, the hernia sac is dissected from the spermatic cord and rejected into the abdomen by high ligation. In direct hernia, the hernia sac is pushed in and the transverse fascia is sutured with 2-3 separe stitches."
15863318|NCT03935490|Procedure|emergency transrectus sheath pre-peritoneal mesh repair (e-TREPP)|"The Trans REctussheath PrePeritoneal mesh repair (TREPP) was developed in 2006 as an open preperitoneal technique to reduce CPIP. In short: a 4-5 centimeters (cm) transverse incision is made about 1 cm above the localization of the deep inguinal ring. The anterior rectus sheath is opened. After retracting the rectus muscle medially, the preperitoneal space (PPS) is bluntly dissected and a complete overview can be achieved. All possible hernia orifices can be visualized such as: a direct, indirect, pantaloon, and/or femoral hernia. A self-expandable mesh is then positioned in the PPS. Due to the upstream principle no mesh fixation is necessary."
15863319|NCT03935477|Device|WellBeing catheter|Urethral catheterisation with integral Wellbeing Catheter to measure bladder tissue oxygen tension
15863320|NCT03935464|Behavioral|PUMA|Collect urine on intervention participants and screen for presence of TFV. Feedback will be provided to the participant based on the results on their adherence with provision of standard adherence counseling.
15863321|NCT03935451|Drug|Apixaban 2.5 milligram|2.5 milligram daily dosing of Apixaban beginning on the first day of hospital discharge for a total of 30 days
15863322|NCT03935451|Drug|Placebo Oral Tablet|placebo oral tablet that resembles the experimental drug. To be taken with the same frequency and duration
15863323|NCT03935438|Other|Cardiac rehabilitation|The training program of cardiac rehabilitation, depending on the results of the patient's medical qualification, will consist of the following: free active exercises, isometric exercises, active exercises in relief with resistance, isotonic exercises, isokinetic exercises, active breathing exercises, active breathing exercises with resistance, balance exercises, general exercises- individual and in groups, interval training on a treadmill or cycling cycloergometer, continuous training on a treadmill or cycling cycloergometer, circuit training, walking training, march training with accessories, autogenic training, walking. The training program will last an average 2 weeks.
15863324|NCT03935425|Device|FitMi Plus|A set of common objects that couple with a wireless sensor platform to allow the performance of functional exercises to be measured by a motivating software platform.
15863325|NCT03935425|Device|FitMi Basic|A wireless sensor platform that allows movement subcomponents and point-to-point exercises to be measured by a motivating software platform.
15863326|NCT03935412|Procedure|Erector Spinae Plane Block|Erector Spinae Plane Block
15863327|NCT03935399|Drug|Oxytocin|10 IU oxytocin (Pitocin) for intramuscular injection
15863328|NCT03935399|Drug|Saline|1.5 ml preservative free saline for intramuscular injection
15863329|NCT03935386|Procedure|Standard Multi-layered Compression dressing|Compression therapy with a multi-layered compression dressing for the treatment of venous leg ulceration
15863330|NCT03935386|Procedure|Standard Multi-layered Compression dressing with a cryopreserved skin allograft (TheraSkin)|Application of a cryopreserved skin allograft (TheraSkin) beneath compression therapy with a multi-layered compression dressing.
15863331|NCT03935373|Diagnostic Test|DNA Exome sequencing|The DNA of Sjögren's syndrome patients and health subjects will take to do the DNA Exome sequencing.
15863332|NCT03935373|Diagnostic Test|Oral microbiome|The saliva of Sjögren's syndrome patients and health subjects will take to do the oral microbiome.
15863333|NCT03935373|Diagnostic Test|Proteomics|The protein of Sjögren's syndrome patients and health subjects will take to do the proteomics.
15863334|NCT03935373|Diagnostic Test|RNA sequencing|The RNA of Sjögren's syndrome patients and health subjects will store to do the RNA sequencing.
15863335|NCT03935373|Diagnostic Test|Cytokine|The serum of Sjögren's syndrome patients and health subjects will store to do the cytokine detection in the future.
15863336|NCT03935373|Diagnostic Test|Traditional Chinese Medicine pattern|Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pattern.
15863337|NCT03935373|Diagnostic Test|Traditional Chinese Medicine tongue diagnosis|Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine tongue diagnosis.
15863338|NCT03935373|Diagnostic Test|Traditional Chinese Medicine pulse diagnosis|Sjögren's syndrome patients and health subjects will take the Traditional Chinese Medicine pulse diagnosis.
15863339|NCT03935373|Diagnostic Test|Heart rate variability|Sjögren's syndrome patients and health subjects will take the heart rate variability.
15863340|NCT03935373|Diagnostic Test|Schirmer's test|Sjögren's syndrome patients will take the Schirmer's test.
15863341|NCT03935373|Diagnostic Test|Blood function test, liver function test, kidney function test, and immune function test|Sjögren's syndrome patients and health subjects will take the blood function test (WBC, RBC, Hb, HCT, Platelet, MCV, MCH, and MCHC), liver function test (AST and ALT), kidney function test (BUN and Cre), and immune function test (RF, Anti-SSA, Anti-SSB Ab, ESR, and CRP)
15863342|NCT03935360|Other|Oakland-Jairath Risk Score|Oakland and Jairath developed a clinical prediction rule for safe discharge among patients with LGIB using data from their UK National Audit. They defined safe discharge as the absence of rebleeding, blood transfusion, need for endoscopic/radiologic/surgical intervention for hemostasis, readmission with LGIB, and death and developed a seven variable risk score: age, sex, previous history of LGIB admission, presence of blood on digital rectal exam, heart rate, systolic blood pressure, and hemoglobin. Using a cut-off score ≤8, they reported excellent discrimination (AUC 0.84, 95% CI 0.82-0.86), good calibration, and a 95% probability of safe discharge.
15863343|NCT03935347|Drug|Cyclophosphamide|Given IV
15863344|NCT03935347|Drug|Fludarabine|Given IV
15863345|NCT03935347|Drug|Fludarabine Phosphate|Given IV
15863346|NCT03935347|Biological|Pembrolizumab|Given IV
15863347|NCT03935347|Biological|Autologous Tumor Infiltrating Lymphocytes LN-145|Given IV
15863348|NCT03935347|Biological|Aldesleukin|Given IV
15863349|NCT03935334|Biological|Biosimilar eptacog alfa, activated (AryoSeven)|A single dose of eptacog alfa biosimilar (AryoSeven) 90 μg/kg or 270 μg/kg. Then, in an open follow up phase of 12 months, for every bleeding episode patients will receive eptacog alfa biosimilar, on demand, for one of more days until resolution of bleeding, based on the Investigator's decision - or - prophylaxis with eptacog alfa biosimilar, with dose, frequency, and duration of treatment based on the Investigator's decision. The modality of treatment (on demand or prophylaxis) will be decided by the Investigator.
15863350|NCT03935334|Biological|Eptacog alfa, activated (Novoseven)|A single dose of eptacog alfa (Novoseven) 90 μg/kg or 270 μg/kg. Then, in an open follow up phase of 12 months, for every bleeding episode patients will receive eptacog alfa biosimilar, on demand, for one of more days until resolution of bleeding, based on the Investigator's decision - or - prophylaxis with eptacog alfa biosimilar, with dose, frequency, and duration of treatment based on the Investigator's decision. The modality of treatment (on demand or prophylaxis) will be decided by the Investigator.
15863353|NCT03935308|Radiation|MR guided Linear Accelerator|The aim is to perform treatment planning to compute the highest feasible simultaneous boosting dose to the intraprostatic lesion while respecting normal tissue dose constraints. Patients will be treated with MR-guided localization and adaptive planning techniques.
15863354|NCT03935295|Drug|AbobotulinumtoxinA|Paraspinal abobotulinumtoxinA injections (compared to placebo)
15863355|NCT03935295|Drug|Placebos|Placebo prepared by Ipsen for use as control
15863356|NCT03935295|Device|Custom Thoracolumbosacral Orthosis|Non-operative external bracing for scoliosis curves
15863357|NCT03935282|Other|AH-HA Tool in the EPIC EHR|The Automated Heart-Health Assessment tool implemented in clinics' EPIC EHR will be used by providers during routine follow-up care appointments.
15863358|NCT03935269|Device|Cereset Research Wearable|CRW is a stress-relaxation device where participants listen to sounds that help to balance brain rhythms. Participants will be asked to come to an office for 5 days over 1-2 weeks, on your their schedule. Sessions will take approximately one (1) hour to complete.
15863359|NCT03935269|Procedure|Stress management therapy|Undergo Cereset research office intervention
15863360|NCT03935269|Other|Questionnaire administration|Ancillary studies
15863361|NCT03935269|Other|Quality of Life Assessment|Ancillary studies
15863362|NCT03935256|Drug|Carboplatin and Paclitaxel|Regimen I: Carboplatin AUC 6 & Paclitaxel 175mg/m2 given intravenously for 4 cycles during weeks 1, 10, 13, 16 Regimen II: Carboplatin AUC 2 & Paclitaxel 45mg/m2 given intravenously for 2 cycles during weeks 4 & 7 concurrent with radiotherapy
15863363|NCT03935256|Radiation|Radiation Therapy|"An external beam radiation dose of 45 Gy in 25 fractions is routinely prescribed to the Planning Target Volume (PTV) for postoperative radiotherapy.
~The Vaginal Brachytherapy (VBT) Boost will be delivered after the external beam radiation. Doses of 12-18 Gy in 2-3 fractions are often prescribed to the surface of the vagina to a treatment length of 3-5 cm. There is no standard dose or fractionation schedule, so this dose, fractionation, location of dose specification , and length of vagina treated will be individualized for the patient and will be at the discretion of the treating radiation oncologist."
15863397|NCT03934944|Other|Usual care|Usual routine of diabetic foot education
15863583|NCT03933449|Drug|docetaxel|IV infusion
15863364|NCT03935243|Behavioral|equine assisted therapy|The equine assisted group therapy is carried out by a riding therapist (nurse psychiatry HF, certified riding therapist SG-TR). There is a detailed plan for the PT.
15863365|NCT03935243|Behavioral|activating control phase|The control phase includes a generally activating employment offer, such as board games, light physical activations, roundtables and artistic design.
15863366|NCT03935217|Drug|Secnidazole|Oral Granules containing secnidazole
15863367|NCT03935217|Drug|Placebo|Oral Granules of placebo manufactured to mimic secnidazole
15863368|NCT03935204|Biological|HPV Vaccine,270μg/1.0ml|HPV vaccine (270μg/1.0ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
15863369|NCT03935204|Biological|Placebo|Aluminium adjuvant (1.0ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule.
15863370|NCT03935191|Device|Dexcom CGM System|Dexcom CGM System
15863371|NCT03935178|Diagnostic Test|Measuring Right Ventricular Size and Function|This study focuses on evaluating different approaches to evaluation of right ventricular size and function using the Upper Valley Right Ventricle Algorithm and novel imaging modalities
15863372|NCT03935165|Drug|Indocyanine Green|"0.25 mg /(kg BW) Indocyanine Green PULSION®/ VERDYE Diagnostic Green®
~- Indocyanine Green is administered Intravenously"
15863373|NCT03935152|Drug|Dydrogesterone|dydrogesterone capsule
15863374|NCT03935152|Drug|placebo|placebo capsule
15863375|NCT03935139|Biological|glucose measurement|Glucose values will be recorded during 5 days as following : every hour at day 0, every 2 hours at day 1, every 3 hours at days 2 to 5.
15863376|NCT03935139|Biological|lactacte measurement|Lactate values will be recorded during 5 days as following : every hour at day 0, every 2 hours at day 1, every 3 hours at days 2 to 5.
15863377|NCT03935139|Biological|pyruvate measurement|pyruvate values will be recorded during 5 days as following : every hour at day 0, every 2 hours at day 1, every 3 hours at days 2 to 5.
15863378|NCT03935139|Biological|glycerol measurement|glycerol values will be recorded during 5 days as following : every hour at day 0, every 2 hours at day 1, every 3 hours at days 2 to 5.
15863379|NCT03935139|Procedure|Bone free flap monitoring|Bone free flaps will be monitored with a microdialysis catheter directly positioned in bone tissue.
15863380|NCT03935126|Diagnostic Test|Diagnostics|Diagnostics
15863381|NCT03935113|Other|Kinesio taping|In KT group, KT was applied using the insertion-origin muscle and space-correction technique of affected upper limb with stroke patients.
15863382|NCT03935100|Procedure|Endoscopic clipping|Endoscopic clips fired to close mucosa over diverticular defects.
15863383|NCT03935100|Other|Placebo - colonoscopy without clipping|Colonoscopy performed, no clipping of diverticula
15863384|NCT03935087|Diagnostic Test|two-dimensional echocardiogram|two-dimensional echocardiogram with evaluation of left ventricle volumes and of left ventricular ejection fraction
15863385|NCT03935074|Drug|intra-arterial administration of melphalan|
15863386|NCT03935061|Other|Mulberry juice|On the second visit at the 1st month, measurements of clinical symptoms and inflammation status are conducted. No mulberry juice is given to patients further on. All patients are evaluated again with the same assessment tools, as well as the immunology markers in their sera during the third visit.
15863387|NCT03935048|Dietary Supplement|Higher protein, low glycemic load diet|"All dietary treatments will be designed to be isoenergetic within individual participants. Energy content of the diets will be individualized to ensure weight maintenance throughout the dietary intervention period using the Harris Benedict equation x 1.35. Glycemic load for the treatment groups will be calculated using the following equation:
~Glycemic Load = Glycemic Index x Grams of carbohydrates/100. Potatoes, processed potato products, and control carbohydrate foods will be provided."
15863388|NCT03935035|Behavioral|internet-delivered Cognitive Therapy for PTSD (iCT)|Participants will receive 10 hours of Cognitive Therapy for PTSD over 12 weeks, with a baseline assessment at the beginning and follow up interview at the end of treatment. The treatment consists of online modules (9 core modules, 11 optional modules and parent/carer modules) and a weekly phone call with a qualified and trained therapist.
15863389|NCT03935022|Other|Rice|"Each group will randomly receive, during three different experimental days, one of the following treatments by different allocation sequences:
~80g of black rice Venere (Group A)
~80g of black rice Artemide (Group B)
~80g of brown rice (Group C) The three treatments will be separated by a 7 day wash-out period. After an overnight fast, volunteers will consume the rice serving within 10-15 min, immediately after the first basal blood collection at 8:00 a.m. (baseline). Other blood withdrawals will be carried out a 0.5, 1.0, 2.0 and 3.0 h after rice administration."
15863390|NCT03935009|Behavioral|Manual toothbrush Curaprox 5460 ultra soft|Soft manual toothbrush (Curaprox 5460 ultra soft) and Jordan Miracle Flossers floss, Curaprox toothpaste 1450 and mobile phone application Chomper Chumswill will be used to brush teeth.
15863391|NCT03935009|Behavioral|Electric toothbrush Play Smart Brush N°1|Electric toothbrush (Play Smart Brush N°1) and Jordan Miracle Flossers floss, Curaprox toothpaste 1450 and mobile phone application Playbrush App will be used to brush teeth.
15863392|NCT03935009|Behavioral|Electric toothbrush Play Smart Brush N°2|Electric toothbrush (Play Smart Brush N°2) and Jordan Miracle Flossers floss, Curaprox toothpaste 1450 and mobile phone application Utoothia will be used to brush teeth.
15863393|NCT03934996|Other|Runners with educational training|"Intervention will consist of an educational talk to know the anatomy and function of the Pelvic Floor Muscles and 20 minutes of both strength and endurance exercises with biofeedback. An exercise protocol will be carried out. The participants will be instruct to contract and maintain maximum force for a mean period of 6 seconds (endurance training) and rest for twice the length of the endurance training time, followed by three fast contractions in a row as strength training. It will be done twice a week, during 12 weeks.
~Pelvic floor assesment: Perineometry, manual palpation, electromyography Trunk and lower limbs electromyography and kinematics"
15863394|NCT03934983|Diagnostic Test|Quantra System|Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
15863395|NCT03934970|Diagnostic Test|Diffusion tensor imaging of peripheral nerves|All subjects underwent evaluation using 1.5T DTI of median nerves and NCS. Patients underwent clinical evaluation using Neuropathy Deficit Score (NDS), Neuropathy Impairment Score in the Lower Limbs (NIS-LL) and Diabetic Neuropathy Examination (DNE) score.
15863396|NCT03934944|Device|Phone application|Weekly foot alerts and educational video
15863399|NCT03934931|Other|Weekly DOT visit reminders|Weekly SMS or interactive voice response (IVR) phone call reminder for DOT clinic visits
15863400|NCT03934931|Other|Cost reimbursement DOT|Reimbursement of costs associated with weekly clinic visits (15,000 Ush/visit in Weeks 2-12)
15863401|NCT03934931|Other|99DOTS|99DOTS-based digital adherence technology to monitor and promote adherence
15863402|NCT03934931|Other|Weekly SAT dosing reminders/check-ins|Weekly SMS or IVR phone call dosing reminder/check-in for side effects
15863403|NCT03934931|Other|Cost reimbursement SAT|Reimbursement of costs associated with streamlined refill and end-of treatment clinic visits (15,000 Ush/visit in Weeks 6 and 12)
15863404|NCT03934918|Other|Treatment|Patients for IOL are sent home after placement of intracervical balloon
15863407|NCT03934892|Diagnostic Test|serum lactate|check lactate levels during cardiopulmonary bypass in adult cardiac operations
15863408|NCT03934879|Behavioral|FitClub|Participants will rotate through each fitness module, which includes spin class, Pilates, strengthening exercises (weight training), basketball, running and rhythm, and cardio fitness. Students will meet five days per week during their first class of the day for 35 minutes and participate in two randomly assigned modules for two week periods. After 2 weeks, they participate in 2 different modules. Resting and peak heart rate (during exercise), calories burned and steps taken will be collected during each session.
15863409|NCT03934879|Other|Regular School Activities|Students will participate in regular school activities.
15863410|NCT03934866|Radiation|Low Dose CT scan|Low Dose chest CT scan conferring an equivalent radiation dose of less than 2 mSv to the average size patient. The study aims to keep most scans under 1 mSv (ultra-low dose), and all scans under 2 mSv.
15863411|NCT03934853|Device|Dynamic Dental Navigation|Aid in dental implant placement in humans
15863412|NCT03934840|Drug|Cabazitaxel|20 mg/m2 Q 21 days
15863413|NCT03934840|Drug|Carboplatin|AUC 4 Q21 Days x 6 cycles with ADT
15863414|NCT03934840|Drug|Abiraterone|1000 mg PO daily
15863415|NCT03934840|Drug|Prednisone|5 mg PO daily on chemotherapy completion
15863416|NCT03934827|Drug|MRx0518 Capsules|MRx0518 is a live biotherapeutic product consisting of a lyophilised formulation of a proprietary strain of bacterium. The dosing regimen is one capsule orally twice daily for 2-4 weeks until surgery.
15863417|NCT03934827|Drug|MRx0518/placebo Capsules|MRx0518/placebo product consist of a lyophilised formulation of either a proprietary strain of bacterium or placebo.The dosing regimen is one capsule orally twice daily for 2-4 weeks until surgery. Placebo capsules are manufactured to mimic MRx0518 capsules and contain the same excipients as the active biotherapeutic product.
15863418|NCT03934814|Drug|TJ011133|TJ011133 will be administered weekly.
15863419|NCT03934814|Drug|Pembrolizumab|Pembrolizumab will be administered every 3 weeks.
15863420|NCT03934814|Drug|Rituximab|Rituximab will be administered weekly for 5 doses, then followed by monthly doses.
15863421|NCT03934801|Other|Brainstorming 1|Expert recommendation statements will be collected for peer evaluation.
15863422|NCT03934801|Other|Ranking Round 1|Each participant will rank each statement using a likert scale: strongly disagree -- disagree -- neutral -- agree -- strongly agree.
15863423|NCT03934801|Other|Ranking Round 2|Each participant will rank each statement using a likert scale: strongly disagree -- disagree -- neutral -- agree -- strongly agree.
15863424|NCT03934801|Other|Ranking Round 3|Each participant will rank each statement using a likert scale: strongly disagree -- disagree -- neutral -- agree -- strongly agree.
15863425|NCT03934788|Device|oxysoft (olifilcon C)|subjects meet certain criteria will be administered randomly oxysoft on both eye for one month on daily wear single use modality.
15863426|NCT03934788|Device|Si-Hy (olifilcon B)|subjects meet certain criteria will be administered randomly Si-Hy on both eye for one month on daily wear single use modality.
15863427|NCT03934775|Device|Finapres Nova|Non-invasive mesurement of hemodynamic parameters and heart rate variability
15863428|NCT03934762|Biological|Placebo|A placebo solution that will not include aloe vera will be applied on the quadriceps of one of the lower limbs.
15863429|NCT03934762|Biological|Natural Aloe Vera|Natural aloe vera solution including peel and leaf from aloe will be applied on the the quadriceps of one of the lower limbs.
15863430|NCT03934762|Biological|Aloe vera soup|Aloe vera solution including aloe vera soup will be applied on the the quadriceps of one of the lower limbs.
15863431|NCT03934749|Device|Non Invasive Ventilation|NIV using standard mode or Lowenstein mode
15863432|NCT03934736|Drug|HEPLISAV-B®|HEPLISAV-B®, a licensed, commercially-available hepatitis B vaccine consisting of the adjuvant cytidine phosphoguanosine (CpG) 1018 combined with the antigen recombinant hepatitis B surface antigen (rHBsAg).
15863433|NCT03934723|Behavioral|Exercise|The intervention consists of 180 minutes of moderate-vigorous aerobic exercise per week for 6 weeks.
15863434|NCT03934710|Drug|Placebo|Drug will be administered in solution form
15863435|NCT03934710|Drug|Serotonin agonist|13ug lysergic acid diethylamide
15863436|NCT03934697|Behavioral|imaginal exposure therapy|All participants will complete the same arm, which is ten sessions of imaginal exposure across a ten week time period. Each session is separated by 1 week.
15863437|NCT03934684|Drug|Drug: Carfilzomib + Dexamethasone|"Drug: Carfilzomib + Dexamethasone
~Carfilzomib will be administered as a 30-minute infusion.
~Dexamethasone will be taken by mouth or intravenously."
15863438|NCT03934684|Drug|Drug: Carfilzomib + Lenalidomide + Dexamethasone|"Drug: Carfilzomib + Lenalidomide + Dexamethasone
~Carfilzomib will be administered as a 10 minute infusion.
~Lenalidomide will be taken orally.
~Dexamethasone will be taken by mouth or intravenously."
15863439|NCT03934671|Device|Antioxidant dressing (active product)|"Antioxidant dressing (active product), covered with secondary dressing. Compression bandage if necessary.
~Device: Reoxcare®"
15863440|NCT03934671|Device|Usual care dressing that create a moist environment (standard clinical practice)|Usual care dressing; moist environment dressing chosen from the study centres' formulary (hydrocolloid, alginate, polyurethane foam dressings, silver dressings). Compression bandage if necessary
15863441|NCT03934658|Device|NightWare Therapeutic System|A wearable digital therapeutic system that will measure physiologic data when worn during sleep to deliver a mild vibration via the watch to elicit arousal thereby disrupting nightmares. This detection and stimulation sequence will be performed according to NightWare's proprietary algorithm.
15863442|NCT03934658|Device|NightWare Therapeutic System in Sham Mode|A wearable digital therapeutic system that will measure physiologic data when worn during sleep that does not deliver interventions.
15863443|NCT03934645|Other|Delirium prediction model for ICU patients, version 1|The pre-deliric model version 1 for intensive care patients consists of ten risk factors that are readily available within 24 hours after intensive care admission and has a high predictive value. The model allows for early prediction of delirium and initiation of preventive measures. Data of the patient in the first 24 hours of admission to the intensive care unit are collected and the delirium prediction score is found.
15863444|NCT03934645|Other|Delirium prediction model for ICU patients, version 2|The pre-deliric model version 2 for intensive care patients consists of ten risk factors that are readily available within 24 hours after intensive care admission. Data of the patient in the first 24 hours of admission to the intensive care unit are collected and the delirium prediction score is found. The model allows for early prediction of delirium and initiation of preventive measures.
15863445|NCT03934645|Other|Early prediction model for delirium in ICU patients|The e-pre-deliric model enables the clinician to identify those patients likely to develop delirium following ICU admission using only nine predictors. In the e-pre-deliric model, delirium prediction score is determined by inputting the data of the patient in admission to the intensive care unit.
15863446|NCT03934632|Other|Postabsorptive|Saline will be infused to mimic postabsorptive circulating amino acid concentrations
15863447|NCT03934632|Other|Postprandial|An amino acid infusate will be administered to mimic postprandial circulating amino acid concentrations
15863448|NCT03934632|Procedure|Immobilisation|One leg will undergo 2 days immobilisation prior to the test day
15863449|NCT03934619|Device|Dolores One|Dolores One, which is a will be applied personal sounds amplification device, will be used to determine if it improves the ability to communication and improves intelligibility
15863450|NCT03934606|Behavioral|Genetic testing for hereditary predisposition|Change in distress levels (HADS-Anxiety) from Baseline to Assessments #2 and #3, measured as an effect size among participants who receive a pathogenic variant(s), no pathogenic variant(s), and variant(s) of uncertain significance
15863451|NCT03934593|Behavioral|Faith-Based (FB, BHT DSMS)|BHT DSMS Intervention components include Health Sermon and a 6-session Health Bible Study with cooking demonstrations, followed by the Stanford DSMP and a Diabetes Resource Seminar. All intervention activities are implemented by trained church lay leaders.
15863452|NCT03934593|Other|Faith-Placed (FP, Stanford DSMP)|Standard Stanford DSMP delivered by health professional
15863453|NCT03934580|Other|hallucinated meal|a breakfast meal (white bread plus ham and cheese with 250 ml still water) is hallucinated by participants under hypnosis
15863454|NCT03934580|Other|Real meal|A real breakfast (white bread plus ham and cheese with 250 ml still water) is consumed by participants
15863455|NCT03934567|Drug|Abexinostat|Abexinostat tablets
15863456|NCT03934541|Biological|MPER-656 Liposome Vaccine|Administered by intramuscular injection
15863457|NCT03934541|Biological|Placebo for MPER-656 Liposome Vaccine|Administered by intramuscular injection
15863458|NCT03934528|Device|Virtual environment activity|Patients undertake an activity using simulated arm movement within a virtual reality environment every day for two months
15863459|NCT03934515|Other|etCO2|"At the end of the procedure, therefore, for each patient two values of etCO2 are acquired which will allow to obtain two populations of values of the etCO2: the values at the endotracheal level and the esophageal level values. The authors will find the threshold value of etCO2 collected when the NGT is well positioned in trachea. The study manager is not directly involved in the measurement and recording of etCO2 values."
15863460|NCT03934515|Other|pH|"At the end of the procedure, for each patient two values of pH are acquired which will allow to obtain two pH value populations: a value at esophageal level and a value at the gastric level. The authors will find the threshold value of pH collected when the NGT is positioned in the esophagus and in the stomach. The study manager is not directly involved in the measurement and recording of pH values."
15863461|NCT03934502|Drug|Evobrutinib|Participants will receive single oral dose of evobrutinib either after an overnight fast of at least 10 hours (Treatment A), within 30 minutes after start of a light meal (Treatment B), 1 hour prior to a low-fat meal (Treatment C), or 2 hours after start of a low-fat meal (Treatment D).
15863462|NCT03934489|Behavioral|PERSIST|12-week group, adapted from Dialectical Behavior Therapy, that focuses on emotion regulation skills training and practice.
15863463|NCT03934489|Behavioral|Facilitated Peer Support|12-week group, adapted from community-based peer support groups, that focuses on participant-generated topics and facilitated discussion.
15863464|NCT03934476|Behavioral|Ketogenic diet|The study subjects randomized for this intervention will observe the ketogenic diet, as prescribed by the protocol.
15863465|NCT03934476|Behavioral|Exercise HIIT|The study subjects randomized for this intervention will observe the HIIT exercise programme, as prescribed by the protocol.
15863466|NCT03934450|Drug|RPQ|The study will compare the individual enantiomers of primaquine - R- (-)-PQ, S-(+)-PQ, and Placebo along with the racemic version.
15863467|NCT03934450|Drug|SPQ|The study will compare the individual enantiomers of primaquine - R- (-)-PQ, S-(+)-PQ, and Placebo along with the racemic version.
15863468|NCT03934450|Drug|Primaquine Phosphate|The study will compare the individual enantiomers of primaquine - R- (-)-PQ, S-(+)-PQ, and Placebo along with the racemic version.
15863469|NCT03934450|Drug|Placebo|The study will compare the individual enantiomers of primaquine - R- (-)-PQ, S-(+)-PQ, and Placebo along with the racemic version.
15863470|NCT03934437|Behavioral|mLTCR|mHealth-enhanced Linkage to Care and Retention
15863471|NCT03934437|Behavioral|LTCR|Linkage and Retention Services (Standard-of-Care)
15863472|NCT03934424|Behavioral|Weight stigma|Subject will read an article depicting discrimination against individuals with higher body weights for 5-10 minutes on one day
15863473|NCT03934424|Behavioral|Ethnic stigma|Subject will read a control article for weight stigma depicting discrimination against individuals from a minority ethnic group for 5-10 minutes on one day
15863474|NCT03934411|Drug|Tramadol|The subjects will orally ingest 100 mg tramadol retard actavis
15863475|NCT03934411|Other|Placebo|The subjects will orally ingest 100 mg calcium powder
15863476|NCT03934398|Diagnostic Test|Cardiovascular Assessments|Participants will undergo the following cardiovascular assessments: 24-hour blood pressure monitoring, arterial stiffness measurements, endothelial function measurements.
15863477|NCT03934398|Diagnostic Test|Actigraphy|Participants will wear an actigraph device for 7 days to measure participant's activity and sleep.
15863478|NCT03934398|Diagnostic Test|Laboratory assessments|Participants will provide blood and urine samples for laboratory assessments.
15863479|NCT03934398|Diagnostic Test|Emotional/Behavioral Assessments|Participants and parents will fill out questionnaires for emotional/behavioral assessments
15863480|NCT03934385|Behavioral|Mental Rehearsal|After each exposure session, participants complete three rehearsal/retrieval exercises that involve viewing images of spiders and completing multiple-choice and free-response questions. Exercises involve retrieving information specific to the spider exposures, reflecting on the experience, and highlighting expectancy violation (i.e., that the participant's feared outcome did not occur).
15863481|NCT03934385|Behavioral|Exposure|All participants complete two exposure sessions. The first set of exposures consists of ten 30-second trials hovering one's hand 3 inches over a live tarantula. The second set of exposures consists of ten 30-second trials placing one's hand inside the spider's terrarium with all five fingertips touching the bottom.
15863482|NCT03934372|Drug|Ponatinib|Ponatinib administered as a tablet or age-appropriate formulation for pediatric participants according to age-based cohort assignment.
15863483|NCT03934359|Drug|DN1508052-01|DN1508052-01 will be administered subcutaneously on Day 1, Day 8 and Day 15 of each cycle.
15863484|NCT03934346|Other|Zinc amino acid complex|Zinc in the form of a Zinc Amino Acid Complex (ZnAA) is provided with a test diet, and the amount of zinc that dissociates from the ZnAA and is thus absorbed via an ionic zinc transport pathway is determined based on the Hill transport kinetics for the respective subject.
15863485|NCT03934333|Drug|BDA MDI 160/180 mcg|Budesonide/albuterol sulfate pressurized inhalation suspension, single dose given as 2 inhalations of 80/90 mcg.
15863486|NCT03934333|Drug|Pulmicort Flexhaler 180 mcg|Pulmicort Flexhaler aerosol, power, single-dose given as 2 inhalations of 90 mcg.
15863487|NCT03934320|Other|FAMCAT|The intervention is a computer-based software algorithm (FAMCAT) for use in general practice with a family history questionnaire.
15863488|NCT03934307|Drug|ALN-AGT01|ALN-AGT01 will be administered by subcutaneous (SC) injection.
15863489|NCT03934307|Drug|ALN-AGT01-Matching Placebo|Normal saline (0.9% NaCl) matching volume of ALN-AGT01 doses will be administered SC.
15863490|NCT03934307|Drug|Irbesartan|Irbesartan will be administered orally.
15863491|NCT03934307|Drug|Irbesartan-Matching Placebo|Irbesartan-matching placebo will be administered orally.
15863492|NCT03934294|Other|Specific acupuncture group|"In addition to routine ICU treatments, patients in the specific acupuncture group will also receive daily bilateral traditional Chinese medicine style acupuncture on the following acupuncture points: ST36 (Zu San Li), ST37 (Shangjuxu), ST39 (Xiajuxu), PC6 (Nei Guan) and LI4 (He Gu). The acupoints indications in this group are specific to treat indigestion related conditions. The treatment will take place once a day, over three days, for a total of three treatments. A total of 10 Needles will be used in each session Acupuncture treatment will be performed with sterile needles manufactured by Yu Kuang acupuncture needles 40mm with 30G."
15863493|NCT03934294|Drug|Metoclopramide 10mg|Patients in all groups will receive Metoclopramide 10mg/ per 8 hours in the case of poor digestion, alongside the individualized drug treatment prescribed by the ICU medical doctor as per individual patient needs.
15863494|NCT03934294|Other|Non-specific acupuncture group|Patients' in the non-specific acupuncture group (Con-Acu) will receive routine ICU treatment as well as a total of 3 daily non digestion related Traditional Chinese medicine style acupuncture treatments at the following acupoints: LI 15 (Jianyu), SJ 14 (JianLiao) LU3 (Tianfu), GB35 (Yangjiao), BL 59 (Fuyang). The selected control points are not indicated for the treatment of digestion related conditions, and are not reported to improve digestive function.
15863495|NCT03934281|Device|Honey dressing Melectis G|"The protocol includes rinsing the wound with the saline, gently drying the edge of the wound, applying a thin Mélectis®G film to the entire wound surface and covering with a secondary dressing.
~Dressings will be rehabilitated based on the evolution of the wound and clinical judgement of the investigator or nurse at home as recommended."
15863496|NCT03934281|Device|HAS recommendation dressing|"Patients included in the standard arm will receive the best available dressing according to the HAS recommendations.
~Dressings will be rehabilitated based on the evolution of the wound and clinical judgement of the investigator or nurse at home as recommended."
15863497|NCT03934268|Genetic|KCNQ2|The researchers extracted DNA from the baby's serum and sent it to WES to get the baby's total exon sequence.
15863498|NCT03934255|Other|Constant Routine Protocol|Constant routine protocols are used in circadian research to examine underlying circadian rhythms in the absence of light, activity, and meals
15863499|NCT03934242|Other|Questionnaire on new born's bedding|Questionnaire on new born's bedding (Child's position in the bed : dorsal, ventral or lateral, presence of pillow or stuffed in bed, presence of coverage and presence of the bed sharing) at two times (during hospitalisation and one month later)
15863500|NCT03934229|Dietary Supplement|Daily intake of study product|Daily intake of Bifidobacterium animalis ssp. lactis 420 or placebo for a 6-month period
15863501|NCT03934216|Drug|BMS-986165|Specified Dose on Specified Days
15863502|NCT03934216|Other|Placebo|Specified Dose on Specified Days
15863503|NCT03934203|Drug|BI 409306|Film-coated tablet
15863504|NCT03934203|Drug|Moxifloxacin|Film-coated tablet
15863506|NCT03934177|Dietary Supplement|Blueberry powder|Dried, powdered blueberries will be consumed at 24 g/day in two divided doses at least 4 hours apart.
15863507|NCT03934177|Dietary Supplement|Placebo powder|A placebo consisting maltodextrin will be consumed at 24 g/day in two divided doses at least 4 hours apart.
15863508|NCT03934151|Procedure|intracorporeal ileocolic anastomosis|laparoscopic bowel transection and ileocolic anastomosis performed inside the abdomen with specimen retrieval in plastic bag
15863509|NCT03934151|Procedure|extracorporeal ileocolic anastomosis|ileocolic anastomosis is carried out by exteriorizing the bowel through a limited laparotomy
15863510|NCT03934138|Other|Educational movie on placebo mechanisms|"Educational movie on placebo mechanisms : animated video, duration : 12 minutes.
~It will be followed by the CPTs : experimentally induced pain by keeping the non dominant hand in cold water (1° Celsius) for a limited time. The duration of immersion is personal and calibrated to be around to ensure that the intensity of pain will be homogeneous (around 7/10 on the visual analogue scale with no treatment)"
15863511|NCT03934138|Other|Informative movie on hand washing|Animated video, duration : 11 minutes. It will be followed by the CPTs : experimentally induced pain by keeping the non dominant hand in cold water (1° Celsius) for a limited time. The duration of immersion is personal and calibrated to be around to ensure that the intensity of pain will be homogeneous (around 7/10 on the visual analogue scale with no treatment).
15863512|NCT03934099|Drug|Xanthine Oxidase Inhibitor|Test drug
15863513|NCT03934099|Drug|Placebo|Matching placebo
15863514|NCT03934086|Drug|rimegepant|rimegepant 75 mg
15863515|NCT03934073|Other|DEXTRAIN|12 sessions of 1 hour of rehabilitation (3 sessions / 4 weeks) for the DexTrain group will consist of 20 minutes of conventional training followed by 40 minutes of exercises using the DexTrain targeting the dexterity components.
15863516|NCT03934073|Other|CONVENTIONNELLE|12 sessions of 1 hour of rehabilitation (3 sessions / 4 weeks) Conventional will be constituted of conventional training consisting of stretching of the spastic muscles as well as exercises used classically in the protocols of rehabilitation post-stroke
15863517|NCT03934073|Other|CONTROLE|Only one assessment will be provided for the control group which will include, Box & Blocks Test (BBT), FFM Dexterity Assessment, Moberg Pick-Up Test (MPUT), Maximal Finger Tapping Rate, Proprioception, SMT, fMRI, Spontaneous hand activity (accelerometry / portable electromyography)
15863518|NCT03934060|Other|Exercise|specific strength training
15863519|NCT03934047|Drug|Tranexamic Acid 100 MG/ML|Visual Field Infiltration of Tranexamic Acid during the operation of total knee replacement.
15863520|NCT03934008|Other|MOtivational interviewing Tool to Improve Vaccine AdherencE (MOTIVE)|The MOTIVE tool incorporates the principles of motivational interviewing (MI) and provides a flowchart approach in which parental health beliefs have a corresponding MI-based strategy to further explore and/or address the hesitancy. The tool was developed from interviews with pediatricians and pediatric pharmacists, a review of the literature focusing on vaccine health beliefs, and the Parent Attitudes about Childhood Vaccines (PACV) Survey Tool. The tool was reviewed by multiple providers and feedback was provided on its usability in clinical practice when interacting with vaccine-hesitant parents and/or caregivers. The tool was then modified based on this feedback. Pediatric providers will complete four educational sessions on vaccine hesitancy, MI, and the use of the MOTIVE tool in clinical practice prior implementation.
15863521|NCT03933995|Other|no Intervention|no Intervention
15863522|NCT03933982|Drug|Pyrotinib Plus Vinorelbine|Pyrotinib: 320mg/d, q.d., p.o. A course of treatment need 21 days. Vinorelbine: 60mg/m2 q.d. d1,8,15, p.o. A course of treatment need 21 day.
15863523|NCT03933956|Drug|Empagliflozin 10 MG|Oral empagliflozin 10mg daily for 30 days
15863524|NCT03933943|Drug|LY3361237|Administered SC
15863525|NCT03933943|Drug|Placebo|Administered SC
15863526|NCT03933930|Other|Lactate-directed therapy|If the lactate level elevates, we transfuse pRBC to increase Hct>30%. If Hct >30%, dopamine infusion starts.
15863527|NCT03933930|Other|Goal-directed therapy|If SVV>15%, transfuse lactate ringer/normal saline alternatively to keep SVV<15%.
15863528|NCT03933917|Procedure|Acute Normovolemic Hemodilution|Following induction of anesthesia, the volume of blood to be removed during Acute Normovolemic Hemodilution was calculated using an established formula:V=Weight（Kg）×12-15（mL/Kg）;Blood to be removed was capped at： Vmax=EVB×(Hi-Hf)/Hav（EBV= estimated blood volume （male:70mL/Kg，female:65mL/Kg）；Hi= initial hemoglobin ；Hf=target Hb（ 10g/dL ）；Hav= the average of the initial and minimal allowable hemoglobin）.Ensure the volume of removed blood does not exceed the upper limit and Hb ≥10g/dL after blood removed.
15863529|NCT03933904|Drug|Sirolimus|Sirolimus (also known as rapamycin) inhibits the mTOR protein kinase and is approved by the USA FDA for the prevention of allograft rejection in renal transplant patients ≥ 13 years of age and for the treatment of lymphangioleiomyomatosis.
15863530|NCT03933891|Procedure|TIPS|TIPS: Established distributary channel between the portal vein and hepatic vein via the jugular vein, portal vein blood directly shunts into the systemic circulation to reduce portal vein pressure to effectively prevent bleeding and refractory ascites.
15863531|NCT03933865|Drug|HYDROmorphone Injectable Solution|Hydromorphone will be given via intramuscular injection (8 mg)
15863532|NCT03933865|Drug|Ketamine|Ketamine will be given via intramuscular injection (0.1, 0.2 or 0.4 mg/kg)
15863533|NCT03933865|Drug|Placebos|Placebo will be normal saline solution given via intramuscular injection.
15863534|NCT03933839|Behavioral|PainCOACH|PainCOACH is an eight-week, automated, internet-based training in specific pain coping skills (such as progressive muscle relaxation, pleasant imagery and activity pacing), and guided practice with each skill.
15863535|NCT03933813|Other|Iron Sucrose|Venofer (Iron Sucrose Injection USP) is a brown, sterile, aqueous, complex of polynuclear iron (III)-hydroxide in sucrose for intravenous use.
15863536|NCT03933800|Device|High flow nasal cannula|High flow nasal cannula therapy
15863537|NCT03933800|Device|Continuous positive airway pressure|Continuous positive airway pressure therapy
15863538|NCT03933787|Drug|Saxagliptin 5mg|Randomised study: session 1 the volunteer will receive either saxagliptin or placebo. Session 2 the volunteer will receive the placebo or saxagliptin
15863539|NCT03933787|Drug|Placebo oral capsule|Randomised study: session 1 the volunteer will receive either saxagliptin or placebo. Session 2 the volunteer will receive the placebo or saxagliptin
15863540|NCT03933787|Other|ergometric test in healthy volunteers|The volunteers will undergo an ergometric test in each session
15863542|NCT03933774|Drug|Placebo cream|Physiogel Daily Mositure Therapy Facial cream, 150mL, Stiefel
15863543|NCT03933761|Drug|Pamiparib|60 mg of pamiparib (3 capsules of 20mg) will be administered orally twice a day, once in the morning and once in the evening continuously in 28 day cycles.
15863544|NCT03933748|Drug|Teicoplanin-PMMA|Therapeutic drug monitoring of teicoplanin
15863545|NCT03933735|Drug|TNB-383B|TNB-383B is a bispecific antibody targeting BCMA on tumor cells and CD3 on T-cells.
15863546|NCT03933722|Device|Caretaker|Application of Caretaker device to subjects that have septic shock and that have an invasive arterial pressure monitor placed.
15863547|NCT03933709|Dietary Supplement|Nutritional Support System (NSS)|Envelope 1 4.9g of Spirulina, 100mg ascorbic acid, 5mg folic acid and 10mg of glutamine. Was to be added to shake 1 during the first 10 days. Envelope 2 1g PUFAs n-3 and was to be added to shake 2 which was given throughout the intervention. Envelope 3 4.9g of Spirulina Maximum, 100mg ascorbic acid, 5mg folic acid, 5.2g vegetable protein, 125mg nicotinic acid, 50mg zinc, 100 mcg selenium and 800 UI cholecalciferol. Was to be added to shake 1 from day 11 until the end of week 6, after which it was suspended for 10 days and substituted for envelope 5 and then to be retaken until the end of the intervention. Envelope 4. 1g arginine and was to be added to shake 3 from day 8 until the end of the intervention. Envelope 5 contained the same ingredients as envelope 3 with an additional 10mg glutamine and was to be added to shake 1 from the start of week 7 for 10 days, after which envelope 3 was restarted. Probiotic at a dosage of 200 mg every 12 hours for 3 days at the beginning and week 6
15863548|NCT03933709|Other|deworming|nitazoxanide at a dosage of 7.5 mg / kg every 12 hours for 3 days.
15863549|NCT03933709|Other|recommended diet|WHO Diet
15863550|NCT03933696|Device|Tailored Lighting Intervention|Lighting Intervention either Active or Placebo
15863551|NCT03933683|Device|Pudendal nerve terminal motor latency assessment|After a specialized coloproctology evaluation, each patient with pelviperineal dysfunction was addressed to dynamic transperineal ultrasound to determine anterior and posterior displacement of puborectalis muscle, and subsequently a blinded neurophysiologist performed pudendal nerve terminal motor latency assessment to identify pudendal neuropathy.
15863552|NCT03933670|Drug|Hyperpolarized Carbon C 13 Pyruvate|Given IV
15863553|NCT03933670|Procedure|Magnetic Resonance Spectroscopic Imaging|Undergo MRSI
15863554|NCT03933670|Procedure|MRI Ultrasound Fusion Guided Biopsy|Undergo MR/US fusion-guided prostate biopsy
15863555|NCT03933657|Device|SoundBite™ Crossing System - Peripheral|SoundBite™ Crossing System consisting of the SoundBite™ Console and SoundBite™ Active Wire 18. The Investigator may use the SoundBite™ Active Wire during the procedure to cross the proximal aspect and/or to cross multiple lesions.
15863556|NCT03933644|Device|Gastric Tube|SGA is inserted with a gastric tube as guide for insertion
15863557|NCT03933644|Device|No gastric Tube|SGA is inserted without a gastric tube as guide for insertion
15863558|NCT03933631|Drug|Pilocarpine|pilocarpine hydrochloride ophthalmic solution 2% (20 mg/mL)
15863559|NCT03933631|Drug|Prednisolone|Prednisolone acetate ophthalmic suspension 1%
15863560|NCT03933631|Drug|Ofloxacin|Ofloxacin Drops
15863561|NCT03933618|Drug|Anastrozole 1mg|
15863562|NCT03933618|Drug|Clomiphene Citrate 25mg|
15863563|NCT03933618|Drug|Placebo - Cap|
15863564|NCT03933605|Drug|midazolam and palonosetron group|intravenous midazolam and palonosetron administraion as prevention of postoperative nausea and vomiting
15863565|NCT03933605|Drug|palonosetron group|intravenous palonosetron administraion as prevention of postoperative nausea and vomiting
15863566|NCT03933592|Procedure|Serratus anterior block|after induction of anesthesia and Patients will be placed in the lateral position with the diseased side up. A linear ultrasound transducer (10-12 MHz) will be placed over the mid-axillary region of the thoracic cage in a sagittal plane. The rib will be counted inferiorly and laterally, until the fifth rib is identified in the mid-axillary line. The following muscles will be identified easily overlying the fifth rib: the latissimus dorsi (superficial and posterior), teres major (superior) and serratus muscle (deep and inferior). The needle (22- G, 50 - mm Touhy needle) will be introduced in-plane with respect to the ultrasound probe targeting the plane superficial to the serratus muscle. Under continuous ultrasound guidance a bolus of 30 ml of 0.25% levobupivacaine 30 mint before skin incision. At the end of surgery, surgeon will put the catheter deep to serratus muscle and get it out with chest tube and fix it followed by an infusion of 5 ml/hour of 0.125% Levobupivacaine.
15863567|NCT03933592|Procedure|thoracic epidural|In group I: thoracic epidural inserted at low thoracic level in sitting position then test dose will be administered to detect any complications then a bolus of 10 ml of 0.25% levobupivacaine 30 mint before skin incision followed by an infusion of 5 ml/hour of 0.125% levobupivacaine after surgery.
15863568|NCT03933579|Diagnostic Test|Deep phenotyping|Each participating hospitals will be collecting whole blood from each patient, through which DNA, RNA, serum, plasma, and peripheral blood mononuclear cells will be extracted from the buffy coat layer for further multi-omics analysis.
15863569|NCT03933566|Procedure|Ultrasound-Guided Superficial Cervical Plexus Block|Ultrasound-Guided Superficial Cervical Plexus Block
15863570|NCT03933566|Procedure|Landmark-Based Superficial Cervical Plexus Block|Landmark-Based Superficial Cervical Plexus Block
15863571|NCT03933553|Other|Aromatherapy with essential oil|the aromatherapy by fragrance inhalation
15863572|NCT03933527|Behavioral|making staining beverage rinse during in-office tooth bleaching|the subjects in experimental group should make staining beverage(coffee or tea) rinse for 30 second, four times daily.
15863573|NCT03933514|Other|Plaque control|Children were instructed about the hygiene procedures
15863574|NCT03933501|Drug|amoxicillin and metronidazole|375 mg amoxicillin and 250 mg metronidazole prescribed on the day of treatment, every 8 hours for 7 days.
15863575|NCT03933501|Drug|Placebos|Two distinct placebo pills prescribed on the day of treatment and taken every 8 hours for 7 days.
15863576|NCT03933488|Drug|TAK-994|TAK-994 tablets.
15863577|NCT03933488|Drug|TAK-994 Placebo|TAK-994 placebo-matching tablets.
15863578|NCT03933475|Device|Virtual reality game|Use of virtual reality games on television screens
15863579|NCT03933462|Device|InnoSpire Go|Participants will use for 30 days.
15863580|NCT03933462|Device|Jet Nebulizer|Participants will use for 30 days.
15863581|NCT03933449|Biological|pembrolizumab|IV infusion
15863582|NCT03933449|Drug|paclitaxel|IV infusion
15863585|NCT03933436|Other|Iodine swabs.|Children will then have their periurethral region gently cleansed for ten seconds with iodine swabs.
15863586|NCT03933436|Other|Saline flush.|Children will then have their periurethral region gently cleansed for ten seconds with saline flush.
15863587|NCT03933423|Device|Home based phototherapy and referral|CHWs will visit the household twice in a month and will counsel mother and families on use of preventive care such as routine antenatal check care and newborn care. The investigators will conduct blood grouping and rhesus (Rh) typing. If the mother is Rh negative, investigators will also measure the Rh status of the father prior to delivery to determine the risk of Rh disease in the newborn. The investigators will establish an emergency contact system both in intervention and comparison arm where mothers and family members contact and inform the research team about delivery. The trained phlebotomist will collect cord blood for measuring glucose 6-phosphate dehydrogenase and infant blood type, Rh status, direct antigen testing. The investigators will develop a protocol for treating infants at home based on the ETAT (Emergency Triage Assessment AND Treatment) AAP (American Academy of Paediatrics) guidelines and treat with LED based phototherapy
15863588|NCT03933410|Drug|KB195|KB195 is a novel glycan
15863589|NCT03933397|Other|Patient-Specific Protocol|Patients assigned to this treatment protocol will be given pain medicine(s) based on the pain medicine(s) they take at home for pain and what was needed during their past hospital and emergency department visits to treat pain. Medicines will include opioids, either morphine or hydromorphone. A member of the outpatient SCD provider team will review the patient's medical record to determine: 1) the patient's maximum home opioid dose, and 2) previous ED analgesic medication(s) and doses that have been effective and safe in the past. The patient's regular hematologist/sickle cell team will write the treatment plans. Medications will be given every 20-30 minutes for up to 6 hours.
15863590|NCT03933397|Other|Weight-based Protocol|Patients assigned to this treatment protocol will be given pain medicine(s) based on their weight. Medicines will include opioids, either morphine or hydromorphone. Plans will be written by the patients regular hematologist/sickle cell team.
15863591|NCT03933397|Drug|Morphine|4 mg for participants weighing <50 kgs, 6mg for participants weighing 50-69.9 kgs, 8mg for participants weighing 70 - 89.9 kgs and 10mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%.
15863592|NCT03933397|Drug|Hydromorphone|1 mg for participants weighing <60 kgs, 1.5 mg for participants weighing 60 - 89.9 kgs, and 2 mg for participants weighing greater than or equal to 90 kgs. dose is given. Re-dosing is every 20-30 minutes up to 6 hours with one possible dose escalation of 25%.
15863593|NCT03933384|Drug|Tenofovir alafenamide|Tenofovir alafenamide 25mg/tab once daily
15863594|NCT03933384|Drug|Entecavir|Entecavir 0.5mg/tab once daily
15863595|NCT03933371|Device|Colon Capsule Endoscopy|The capsule endoscopy will be ingested by the participant. This device captures images along the large bowel. This images are stored in an external memory and afterwards they are downloaded in a computer
15863596|NCT03933358|Other|Thyroid hormone levels|This is an observational study. Exposure: Different thyroid hormone levels.
15863597|NCT03933345|Other|Study provides naloxone to participants who wish to have it. Not required to accept naloxone and no control.|At enrollment, participants will complete a detailed survey instrument establishing histories of substance use, naloxone exposure, and other potential barriers to the uptake of naloxone training. Because extant research establishes a clear public health and ethical imperative to provide PWUIO with naloxone, we will also offer all participants training to become naloxone-equipped OD responders at enrollment. We will follow the sample for two years using a mixed-methods approach involving text-message-based exposure tracking, monthly surveys using a state-of-the-art online data collection portal, and a qualitative subsample to ensure that naloxone exposures and changes in OD risk behavior are carefully tracked and contextualized by ethnographic data about the psychosocial and sociocultural mechanisms underlying participant experiences.
15863598|NCT03933332|Other|Diaphragm thickness|measured at apposition zone using ultrasonography in mm
15863599|NCT03933332|Other|Cross-sectional area of rectus femoris muscle|measured at lower one-third line between Spina iliaca anterior inferior (SIAI) and upper border femur patella using ultrasonography in cm^2
15863600|NCT03933332|Other|Cross-sectional area of biceps brachii|measured at biceps brachii muscle using ultrasonography in cm^2
15863601|NCT03933332|Diagnostic Test|C-Reactive Protein (CRP) Level|quantitative CRP using ELISA method in mcg/mL
15863602|NCT03933319|Drug|pegylated liposomal doxorubicin|Eligible patients will be treated with the PLD+trastuzumab regimen until the disease progresses or intolerable toxicity
15863603|NCT03933306|Drug|Dexmedetomidine|Loading dose dexmedetomidine (0.6 mcg/kg for 10 min) administered before anesthesia induction, followed by a continuous infusion (0.5 mcg/kg/h) until 1 hour before the end of surgery.
15863604|NCT03933306|Drug|Placebo|Loading dose placebo administered before anesthesia induction, followed by a continuous infusion until 1 hour before the end of surgery.
15863605|NCT03933306|Other|Goal-directed blood pressure management|Blood pressure is maintained within ±10% of baseline with noradrenaline infusion and fluid management.
15863606|NCT03933306|Other|Routine blood pressure management|Blood pressure is maintained according to routine practice, i.e., systolic blood pressure > 90 mmHg or within ±30% of baseline within intermittent ephedrine or phenylephrine.
15863607|NCT03933293|Drug|AK102|450mg, Q4W, subcutaneous injection
15863608|NCT03933293|Drug|Statins|Lipid-lowering therapies
15863609|NCT03933293|Drug|Ezetimibe|Lipid-lowering therapies
15863610|NCT03933280|Drug|Nalbuphine|i.v. nalbuphine bolus of 50 μg/kg.
15863611|NCT03933280|Drug|Propofol|A bolus i.v. dose of propofol 0.5 mg/kg followed by an infusion of 0.025 mg/kg/min
15863612|NCT03933280|Drug|Dexmedetomidine|i.v. loading dose of dexmedetomidine 1 μg/kg over 10 min followed by a maintenance infusion of 0.5 μg/kg/h.
15863613|NCT03933280|Drug|Benoxinate Hydrochloride 0.4% Eye Drops|Benoxinate hydrochloride 0.4% eye drops instilled twice, 5 minutes apart.
15863636|NCT03933046|Diagnostic Test|PSG|polysomnography and urine analaysis for protein levels
15863637|NCT03933033|Device|Fractional Erbium Yağ Laser|Multiple sessions of Fractional Erbium Yağ Laser
15863638|NCT03933033|Procedure|Platelet Rich Plasma|Multiple injections of Platelet Rich Plasma
15863915|NCT03930758|Combination Product|Dietary intervention of exercise after the meal|40 minutes of downhill exercise started 1 hour after the meal
15863614|NCT03933267|Other|Cervical sensorimotor control training exercises|"Cervical sensory motor training exercises consisting of cervical position sense and cervical movement sense exercises with 3 levels of difficulty and 5 repetitions * 3 sets for each exercise will be given. Some exercises are:
~Head relocation with laser feedback:
~head relocation to neutral and predetermined position with eyes opened (in horizontal / vertical direction) (5 reps x 3 sets) Head relocation to neutral, predetermined and to specific targets with eyes opened (in diagonal directions) (5 reps x 3 sets) Head relocation to neutral and predetermined position with eyes closed (in all directions)(5 reps x 3 sets) In addition to it conventional physical therapy protocol consisting of Generalized stretching and cervical strengthening exercises along with joint mobility."
15863615|NCT03933267|Other|Conventional Exercises|conventional physical therapy protocol consisting of Generalized stretching and cervical strengthening exercises along with joint mobility exercises will be given to patients.
15863616|NCT03933254|Diagnostic Test|Intraocular pressure measurement via ocular tonometry|Intraocular pressure and optic nerve sheath diameter changes of the patients undergoing laparoscopic cholecystectomy will be measured throughout the surgery at different times using ocular tonometry and ultrasound, respectively.
15863617|NCT03933241|Behavioral|nasal irrigation|nasal irrigation after Transnasal transsphenoidal surgery for pituitary tumor
15863618|NCT03933228|Procedure|Interscalene-Cervical Plexus Block|Ultrasound-Guided Combined Interscalene-Cervical Plexus Block
15863619|NCT03933228|Procedure|Supraclavicular-Cervical Plexus Block|Ultrasound-Guided Combined Supraclavicular-Cervical Plexus Block
15863622|NCT03933189|Other|Physical Therapy|Physical therapy modalities to treat chronic pain
15863623|NCT03933176|Procedure|Restoration of carious lesions|Selective carious tissue removal followed by restoration of the cavity using composite resin.
15863624|NCT03933163|Drug|Resveratrol|Drug name: Micronised resveratrol. Dosage form: 500mg capsules. Alternate name: 1,3-Benzenediol, 5-[2-(4-hydroxyphenyl)ethenyl]-, (E). Ingredients: 99.50% pure trans-resveratrol. Placebo capsules will be identical in terms of taste, smell, and appearance.
15863625|NCT03933150|Device|ultrasound guided caudal epidural injection|"A. Ultrasound-Guided CESI (Group 1) All the injection procedures were performed as an outpatient clinic setting. We used Acuson P300 (Siemens, Italy) with a linear transducer at 6 to 12 MHz as the US instrument, another curved transducer at 2-5 MHz was available for obese patients.
~B. Fluoroscopy-Guided CESI (Group 2) All the injection procedures were performed in a specialized room with a FL device in the radiology department. We used a FL device GS 1004 with ALLURA XPER FD 20 system (Philips, Holland) with X-ray tube housing assembly, X-ray tube, beam limiting device and image receptor"
15863626|NCT03933137|Other|Portsmouth Physiological and Operative Severity Score for the Enumeration of Mortality and Morbidity (P-POSSUM) score|P-POSSUM score's variables are divided into physiological parameters (age, cardiac, respiratory, ECG, systolic blood pressure, pulse rate, haemoglobin, leukocyte count, urea, sodium plasma, potassium plasma, and GCS) and operative parameters (operation type, number of procedures, operative blood loss, peritoneal contamination, malignancy status, CEPOD).
15863627|NCT03933124|Device|Virtual Reality|The Virtual Reality intervention is used for 10 minutes minimal 3 times a day on postoperative day 2-4.
15863628|NCT03933111|Diagnostic Test|local sound velocity measurement|All patients are scanned by Fuji film su-9000 ultrasonic system. After the lesions are found, local sound velocity measurement technology will be used to measure the sound velocity in the lesions.Pathology diagnosis or clinical follow-up results will be regard as diagnostic gold standard divide the patients into pancreatic cancer and pancreatic cancer group.
15863629|NCT03933098|Biological|Test Vaccine Vi-DT Typhoid conjugate|"Manufacturer: SK Bioscience Co., Ltd.
~Ingredient: Purified Vi-polysaccharide conjugated to diphtheria toxoid
~Dose: 25 µg of Vi polysaccharide/0.5 mL, presented in 3 mL multi-dose glass vial"
15863630|NCT03933098|Biological|Control Vaccine Typbar TCV®|"Manufacturer: Bharat Biotech
~Ingredient: Purified Vi capsular polysaccharide of Salmonella Ty2 conjugated to tetanus toxoid protein
~Dose: 0.5 ml"
15863631|NCT03933085|Behavioral|Memory Support System (MSS)|A calendar/notetaking system focused on training a person with MCI to use a specific external memory compensatory strategy to complete relevant IADLs independently.
15863632|NCT03933072|Procedure|obtaining of autologous human olfactory bulb, autologous sural nerve preparation|The operative procedure will be aimed to obtain one of the patient's olfactory bulbs. The operation will be performed using a minimally invasive intracranial microsurgical endoscopy-assisted or transnasal endoscopic approach. During the same operation the patient sural nerve will be prepared for a future grafting.
15863633|NCT03933072|Biological|production of Glial Neuropatch|The human autologous olfactory ensheathing glia and olfactory fibroblast isolated from the olfactory bulb will be used for production of Glial Neuropatch in a laboratory facility in accordance with good manufacture procedures (GMP). The final Product will consist of the aforementioned cell suspension embedded with collagen scaffold. The European Medicines Agency/Committee for Advanced Therapies (EMA/CAT) considers that the Product Glial Neuropatch falls within the definition of a tissue engineered product of an advanced therapy medicinal product (decision EMA/CAT/293903/2018 from 22 June 2018: Scientific recommendation on classification of advanced therapy medicinal products Article 17 - Regulation (EC) No 1394/2007).
15863634|NCT03933072|Procedure|microsurgical reconstruction of the transected spinal cord with autologous Glial Neuropatch-nerve bridges|The surgery will consists of laminectomy/laminotomy, midline durotomy above the area of spinal cord lesion, detethering of the spinal cord from fibrotic adhesions, resection of the posttraumatic spinal cord glial scar, delivering of cultured OEC/ONFs explants (Glial Neuropatch) to the area of spinal cord injury and finally bridging of the spinal cord gap by harvested autologous sural nerve grafts.
15863635|NCT03933059|Other|Psychotherapy|Cognitive Processing Therapy is a primarily cognitive form of Cognitive Behavioral Therapy, which has been shown to be effective at reducing symptoms of PTSD.
15878819|NCT03814005|Drug|Carboplatin|Carboplatin intravenous infusion.
15863639|NCT03933020|Device|VR active video game intervention|The Microsoft VR active game program will consist of 3 weekly sessions of 45 minutes each combining 3 different types of exercise
15863640|NCT03933020|Behavioral|Educational session|This consists of two education discussion sessions on the benefits of exercise for people with MS. The investigator MS specialists will conduct these sessions either by phone or at the time of a clinic visit and will also discuss difficulties encountered by participants with adherence.
15863641|NCT03933020|Behavioral|Standard Management of Physical Activity|Routine discussion of lifestyle factors including physical activity during clinic visits
15863642|NCT03933007|Drug|Colchicine,|"the day of phenotyping assay
~Colchicine : 1.5 mg over 1 hour (1 mg + 0.5 mg 1 hour later)"
15863643|NCT03933007|Drug|midazolam,|Midazolam 1 mg
15863644|NCT03933007|Drug|fexofenadine|Fexofenadine 120 mg
15863645|NCT03932994|Behavioral|ACT on Health|This intervention consists of an online canvas course based on Acceptance and Commitment Therapy, focused on increasing healthy diet and physical activity and addressing barriers to change. The intervention also consists of weekly phone coaching calls.
15863646|NCT03932981|Drug|Temozolomide|Temozolomide at a monthly standard dose of 150-200 mg/m2/day at day 1 to day 5 for a duration of treatment of 12 months
15863647|NCT03932968|Procedure|pH-metry during 24 hours|For patients with gastric symptoms such as retrosternal burning, regurgitations, and epigastric pain, a pH-metry will be performed
15863648|NCT03932955|Biological|MC-19PD1 CAR-T cells|T cells purified from the PBMC of subjects, transduced with anti-CD19 CAR and PD1/CD28 chimera lentiviral vector, expanded in vitro for future administration.
15863649|NCT03932942|Diagnostic Test|QIAstat at pediatric emergency room|Pediatric acute care nurses will obtain respiratory samples for testing from all patients with fever or any respiratory symptom.
15863650|NCT03932929|Device|Scotchbond Universal Adhesive (3M ESPE)|Adhesive system
15863651|NCT03932916|Drug|Donepezil Pamoate for Injection 17mg|A dosage of 17mg HHT201 will be injected into the muscle in the gluteus once.
15863652|NCT03932916|Drug|Donepezil Pamoate for Injection 34mg|A dosage of 34mg HHT201 will be injected into the muscle in the gluteus once.
15863653|NCT03932916|Drug|Donepezil Hydrochloride 5mg|A tablet of 5mg Donepezil Hydrochloride will be administered once.
15863654|NCT03932903|Behavioral|AYA ADAPTS (ADherence Assessments and Personalized Timely Support).|AYA ADAPTS is a mobile app intervention that integrates contextually-tailored mobile messages and decision rules about when to deliver the messages, with the ultimate goal of improving oral chemotherapy adherence in adolescents and young adults with acute lymphoblastic leukemia. Each participant will be micro-randomized to receive messages on some days that are adapted to their current characteristics (e.g., mood, pain, location) and designed to promote adherence, and no messages (no intervention) on other days.
15863655|NCT03932890|Device|Patient controlled fluid device administering high volume thirst guided fluid bolus|The administration of a 200ml fluid bolus in response to subjective thirst. Participant activates trigger in response to thirst which activates fluid pump to deliver 50ml IV fluid bolus of 4% dextrose & 0.18% sodium chloride
15863656|NCT03932890|Device|Patient controlled fluid device administering low volume thirst guided fluid bolus|The administration of a 50ml fluid bolus in response to subjective thirst. Participant activates trigger in response to thirst which activates fluid pump to deliver 50ml IV fluid bolus of 4% dextrose & 0.18% sodium chloride
15863657|NCT03932877|Other|MMP-14 and s-ENG levels|Venous blood sampled from the antecubital veins for measuring the serum concentration of MMP-14 and s-ENG levels. The serum MMP-14 and s-ENG levels measured using commercially available reagent kits, which is produced to detect human MMP-14 and s-ENG levels (Rel Assay Diagnostics Gaziantep, Turkey). The MMP-14 and s-ENG levels measurements were performed in accordance with the company's protocol.
15863658|NCT03932864|Biological|MGTA-145|MGTA-145 will be given in various doses intravenously
15863659|NCT03932864|Biological|plerixafor|240 µg/kg subcutaneously
15863660|NCT03932864|Biological|Placebo|Placebo will be given in various doses intravenously
15863661|NCT03932851|Other|IVF-ET|HBV-infected pregnant women and non-HBV-infected pregnant women underwent IVF operation
15863662|NCT03932838|Other|Clinical and radiologic evaluation|Follow up post surgery: clinical and radiologic evaluation
15863663|NCT03932825|Drug|Nitrous Oxide|An 1-hour session of inhaled nitrous oxide at concentrations of 50%.
15863664|NCT03932825|Drug|Placebo|An 1-hour session of mixed oxygen-air gas(inspired oxygen concentration ~50%)
15863665|NCT03932812|Behavioral|Options Counselor Health Educator (OC-HE) Intervention|The OC-HE will meet in person with the participant one time and five times via telephone to provide options counseling based on modules developed by the research team
15863666|NCT03932799|Other|Prospective prior authorization (PA) with hard stops in Washington|"Under Washington regulatory procedures, payment for any opioid prescription billed beyond six weeks after the injury is denied unless the prescriber has submitted a checklist attesting to completion of all best practices from the regulations/guidelines.Thus, the Washington intervention is prospective and includes a hard stop subject to an insurer's decision based on regulatory authority."
15863667|NCT03932799|Other|Retrospective review (RR) with prescriber notification in Ohio|In Ohio an automated report identifies new opioid prescriptions beyond the acute phase. Ohio Workers' Compensation pharmacy and clinical staff review the medical record at 12 weeks to determine whether best practices were met. If not, the prescriber is notified via letter, and cases are reviewed again at 16 weeks. If best practices have still not been met, the prescriber and worker are notified via letter that opioid coverage will end in 4 weeks. The Ohio program relies on retrospective chart review and communication of best practices to prescribers.
15863668|NCT03932786|Procedure|Biospecimen collection|Collection of tissue and saliva samples
15863669|NCT03932786|Other|Vision assessment|Undergo vision assessment
15863670|NCT03932786|Other|Questionnaire administration|Complete questionnaires
15863671|NCT03932786|Other|Quality of life assessment|Complete questionnaires
15863672|NCT03932786|Other|Laboratory Biomarker Analysis|Correlative studies
15863696|NCT03932591|Procedure|kinesio taping method|Kinesio tape is an elastic, adhesive, hypo-allergenic, latex-free tape. Kinesio taping method is rehabilitative taping technique. One of the purposes of this technique is to facilitate or inhibit the muscles.
15863916|NCT03930758|Combination Product|Behavioral intervention of sedentary no-exercise trial|Sedentary no-exercise trial
15863673|NCT03932773|Device|Active rTMS|"A Magstim Rapid2 Stimulator repetitive transcranial magnetic stimulation (rTMS) device will be used to deliver 1 hertz (Hz) stimulation to right dorsolateral prefrontal cortex (rDLPFC) at 110% of a participant's rTMS motor threshold. The device passes electric current through a coil generating an alternating magnetic field. When positioned over the skull, the changing magnetic field causes electromagnetic inducted current flow in brain regions subjacent to the coil. Magnetic pulses (1.5-2.0 Tesla) lasting 100-300 microseconds at 1 Hz will be used.
~Motor threshold will be defined by the TMS intensity to right motor region required to induce visually perceptible movement of the contralateral abductor pollicus brevis 50 percent of the time."
15863674|NCT03932773|Device|Sham rTMS|"A Magstim Rapid2 Stimulator repetitive transcranial magnetic stimulation (rTMS) device will be paired with sham coil. The sham coil will induce electrical current flow in the tissue above the skull but will not induce current flow in brain tissue. The sham coil will be placed over the right prefrontal scalp region to target current flow in rDLPFC. Magnetic pulses lasting for 100-300 microseconds at 1 Hz will be used.
~For consistency across the rTMS conditions, motor threshold in the sham condition also will be determined by positioning the active rTMS coil over the right motor region and identifying the stimulation intensity required to induce visually perceptible movement of the contralateral abductor pollicus brevis 50 percent of the time."
15863675|NCT03932773|Behavioral|Cognitive Processing Therapy|Cognitive Processing Therapy (CPT) is an evidenced based, trauma-focused treatment for Posttraumatic Stress Disorder (PTSD). CPT is a recommended form of treatment in the Veterans Administration - Department of Defense Clinical Practice Guideline for PTSD. The CPT manual delineates the agenda for each of 12 sessions (60 minutes per session): 1) Introduction to CPT and Patient Education regarding PTSD, 2) Meaning of the Trauma, 3) Identification of Thoughts and Feelings related to the Trauma, 4) Remembering the Trauma, 5) Identification of Stuck points, 6) Challenging Questions about the Trauma, 7) Dysfunctional/Maladaptive Thinking patterns related to the Trauma, 8) Safety Issues, 9) Trust Issues, 10) Power and Control Issues, 11) Self-Esteem Issues, and 12) Intimacy Issues.
15863676|NCT03932760|Behavioral|UPLIFT Program|UPLIFT is based on cognitive behavioral therapy and mindfulness-based practices. Participants meet by videoconference using any electronic device (laptop, tablet, smart phone) from their own home.
15863677|NCT03932760|Behavioral|Attention Control Group|Program is based on standard prenatal, childbirth, infant feeding, and parenting education curriculum. Participants meet by videoconference using any electronic device (laptop, tablet, smart phone) from their own home.
15863678|NCT03932747|Other|pre- Hydratión skin|Measurement of hydration of the skin.
15863679|NCT03932747|Other|post- Hydratión skin|Measurement of hydration of the skin.
15863680|NCT03932734|Other|survey|Face-Q conversion table
15863681|NCT03932721|Drug|Evolocumab 140 MG/ML|Evolocumab is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). PCSK9 is a protein that targets LDL receptors for degradation and thereby reduces the liver's ability to remove LDL-C.
15863682|NCT03932708|Behavioral|CDC Core Elements of Outpatient Stewardship|The intervention is described above and includes components of leadership, action of policy and practice, tracking and reporting, and education and expertise.
15863683|NCT03932695|Dietary Supplement|Low dose milk peptide|what is the effect of milk peptides 1400mg on postprandial glycemia after a meal rich in carbohydrates (75g)
15863684|NCT03932695|Dietary Supplement|High Dose milk peptide|what is the effect of milk peptides 2800mg on postprandial glycemia after a meal rich in carbohydrates (75g)
15863685|NCT03932695|Dietary Supplement|Placebo|what is the effect of placebo on postprandial glycemia after a meal rich in carbohydrates (75g)
15863688|NCT03932669|Drug|Nilotinib|150-300mg daily dose of nilotinib
15863689|NCT03932656|Behavioral|Combined schema-therapy and cognitive behavioral therapy|A six-week inpatient psychotherapeutic program consisting of one small group and one big group therapy per day, one individual session per week, daily sport activities, imagery and relaxation techniques. The therapeutic approach presents a combination of schema-therapy and cognitive behavioral therapy. Schema-therapy will follow guidelines for the treatment of individuals with borderline personality disorder (Farrell and Shaw 2012). A later step in the therapy - strengthening of the called Healthy Adult (that is the ability to perceive situations realistically, think rationally, plan time, set appropriate goals, or behave assertively) will be done by standard cognitive behavioral strategies (cognitive restructuring, core beliefs work, time planning, problem solving, assertiveness training). A detailed description of the program is going to be published in a paper.
15863690|NCT03932656|Drug|Psychopharmaceuticals|Pharmacotherapy will be implemented according to the National Institute for Health and Care Excellence guidelines and will target comorbidities if present to such extent that warrants a pharmacological intervention. If not needed, patients will not use medication. Most patients will be recommended to hospitalization by their outpatient psychiatrists who prescribe the medication. If needed, medication will be changed to meet the guideline standards (i.e., tapering off benzodiazepines or augmentation with a mood stabilizer). The medication will be controlled but not directed by the study.
15863691|NCT03932643|Drug|ONC201|"ONC201 Capsules, 125 mg
~Oral ONC 201 at various dose levels will be given at weekly intervals for up to 13 cycles (52 weeks); 4-week therapy will be considered 1 cycle."
15863692|NCT03932630|Other|Low carbohydrate diet|The study intervention will be an eucaloric low carbohydrate diet (15-20 % of carbohydrates) for 2 weeks.
15863693|NCT03932630|Other|balanced diet|The control intervention will be a energy-matched balanced diet (50 % of carbohydrates) for 2 weeks.
15863694|NCT03932617|Device|end tidal carbon dioxide by capnography|"Moreover, since PETCO2 is mainly determined by tissue CO2 production (VCO2), alveolar ventilation and CO, when stable metabolic conditions are assumed and minute ventilation is kept constant, acute changes in PETCO2 have been shown to correlate strongly with changes in CO.
~Thus, PETCO2 has been suggested as a simple economic and noninvasive alternative for continuous assessment of CO in different shock states."
15863695|NCT03932604|Device|Atrial sensing On mode|Single lead VDD-ICD programmed as atrial sensing On mode.
15878820|NCT03813992|Drug|MED2005|Topical Product
15863697|NCT03932591|Procedure|Sham kinesio taping|Sham kinesio tape will be used for controlled group. 2,5 cm width, 5 cm length, skin color 2 pieces kinesio tape will be applied on medial and lateral head of gastrocnemius muscle without stretch. 5 cm length, 5 cm width, skin color 1 piece kinesio tape will be a
15863698|NCT03932578|Drug|Atropine sulfate|Patients will receive intrathecal 100 μg of a 1 mg/ml preservative-free atropine sulfate solution
15863699|NCT03932578|Drug|Metoclopramide|Patients will receive IV metoclopramide 10 mg in 2 ml
15863700|NCT03932565|Biological|CAR-T therapy for nectin4-positive malignant solid tumor|The Intravenous minimally invasive surgery combined with intratumoral injection of Nectin4/FAP-targeted the fourth-generation CAR-T cells (expressing IL7 and CCL19, or IL12) are used to treat Nectin4-positive advanced malignant solid tumors, maximally eliminating residual cancer cells and preventing recurrence.
15863701|NCT03932552|Other|Exercise|aerobic exercise program during 2 + 12 weeks, highly monitored and tailored to individual physical capacity.
15863702|NCT03932552|Other|nutritional therapy|individualised nutritional intervention
15863703|NCT03932526|Drug|Vinorelbine + placebo|Combined administration of vinorelbine and placebo. Based on oral administration of vinorelbine, the patients will be given oral placebo (starch as an ingredient). The placebo appearance, including shape, size, color and weight, taste, labeling and packing are the same with those of apatinib mesylate tablets.
15863704|NCT03932526|Drug|Vinorelbine + Apatinib|Combined administration of vinorelbine and apatinib. Vinorelbine tartrate soft capsule (also named Navelbine; registration No. H20140657; Pierre Fabre Medicament, Boulogne, France) 40 mg once orally, taken in the morning (at least 1 hour before or at least 1 hour after meals), three times a week (Mondays, Wednesdays, and Fridays), for a continuous 21-day cycle. Apatinib mesylate tablets (also named Aitan, State Medical Permission No. H20140103; Jiangsu Hengrui Pharmaceutical Co., Ltd., China), 500 mg orally, taken once a day for a continuous 21-day cycle.
15863705|NCT03932513|Drug|inarigivir soproxil|Inarigivir 200mg and 400mg oral tablets, once daily
15863706|NCT03932487|Other|urinary iodine and urine BPA|urinary iodine and urine BPA
15863707|NCT03932474|Combination Product|SAMEUp|One tablet per day of food supplements containing S-adenosyl methionine (SAMe) 200 mg and Lactobacillus plantarum HEAL9 1x109 CFU.
15863708|NCT03932474|Other|Placebo|One tablet per day identical in shape, size, colour and taste to the SAMEUp tablet
15863709|NCT03932461|Procedure|Vacuum assisted closure|The Vacuum assisted closure system consists of an abdominal dressing covering the intra abdominal viscera over the dressing there will be placed a blue sponge which will be covered by drape and connected to a vacuum pump.
15863710|NCT03932461|Procedure|"Relaparotomy on demand"|Abdomen is closed at the index operation after source of peritonitis is treated. Every 48-hours the patients are evaluated for the need of relaparotomy based on clinical and paraclinical parameters.
15863711|NCT03932448|Other|The proposed study is not interventional.|The proposed study is not interventional. However, if a treatable microorganism is detected, e.g. Borrelia or Anaplasma, suitable therapy, e.g. doxycycline, will be in initiated if appropriate.
15863712|NCT03932435|Drug|Fisrt period TWLO_C|"First Period: Single oral administration of 1 tablet of Dong-a Bepotastine Besilate Tab(Bepotastine Besilate 10mg)"
15863713|NCT03932435|Drug|Fisrt period TWLO|"First Period: Single oral administration of 1 tablet of Twolion Tab(Bepotastine Besilate 10mg)"
15863714|NCT03932435|Other|Washout period|7 days
15863715|NCT03932435|Drug|Second period TWLO_C|"Second Period: Single oral administration of 1 tablet of Dong-a Bepotastine Besilate Tab(Bepotastine Besilate 10mg)"
15863716|NCT03932435|Drug|Second period TWLO|"Second Period: Single oral administration of 1 tablet of Twolion Tab(Bepotastine Besilate 10mg)"
15863717|NCT03932422|Diagnostic Test|Evaluate if the individuals are resistant hypertensive patients|Evaluation of the individuals has the objective determine if they are resistant hypertensive patients. This is important because the resistant people have worse prognosis than the controlled people and need more attention from the health professionals. Analysis must be done using the ambulatory blood pressure monitoring.
15863718|NCT03932409|Drug|Pembrolizumab|"prior to VCB: 200mg IV given one week (7 days) before radiation
~after VCB: 200mg IV on day 1 of a 21 day cycle prior to chemotherapy"
15863719|NCT03932409|Radiation|Vaginal cuff brachytherapy (VCB)|Treatment should commence within 12 weeks of the surgery/hysterectomy
15863720|NCT03932409|Drug|Paclitaxel|after VCB, Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles
15863721|NCT03932409|Drug|Carboplatin|after VCB, Carboplatin IV on day 1 of a 21 day cycle for 3 cycles
15863722|NCT03932396|Other|Observational study|No intervention is planned outside of usual clinical practice. Only active screening for hepatotropic virus infection, mainly hepatitis C virus, HIV, and mental illness will be carried out. If any disease is detected, patients will be referred to the corresponding specialized care following the usual clinical practice.
15863723|NCT03932383|Device|Custom CPAP mask|Modified CPAP mask based on 3D image capture
15863724|NCT03932370|Procedure|endoscopic surgery|The procedure will be performed in an endourology room where a radiolucent operative table together with a C-arm, a video-camera unit and a Laser device are available. Irrigation fluids include normal saline and/or sterile water
15863725|NCT03932357|Radiation|CBCT|measuring soft tissue thickness using a CBCT
15863726|NCT03932344|Drug|Anakinra|Anakinra according to prescription
15863727|NCT03932331|Drug|Acalabrutinib|Acalabrutinib 100 mg orally twice daily
15863728|NCT03932318|Biological|Lintuzumab-Ac225|In the Phase I, patients will be enrolled into the following dose escalation cohorts: 0.50 μCi/kg, 1.0 μCi/kg, and 1.5 μCi/kg. If the 0.50 μCi/kg dose is determined to exceed the MTD, a 0.25 μCi/kg dose will be explored.
15863729|NCT03932318|Drug|Venetoclax|400 mg daily will be taken orally on Days 1-21 of a 28-day cycle. There will be a ramp up of venetoclax dosing in the first cycle, with 100 mg administered on Day 1, 200 mg on Day 2, and 400 mg on Day 3 and Day 4 and later. Patients on antifungal azoles should receive one-half these doses, up to a maximum of 200 mg of venetoclax.
15863730|NCT03932318|Drug|Azacitidine|75 mg/m2 will be administered on days 1-7 of a 28-day cycle.
15863731|NCT03932305|Dietary Supplement|Lutein|Lutein is a common oral supplement that may have neuroprotective effect on the human retina
15863732|NCT03932305|Dietary Supplement|Placebo|Inactive placebo tablet
15863917|NCT03930758|Combination Product|Dietary intervention of eating two meals|Meals eaten at 10 and 17 h during a sedentary trial
15863733|NCT03932292|Drug|Ectoin Mouth Wash|According to medical prescription of the instruction for use under consideration (at least 4x1 ampoule (5ml) daily, rinsed in the mouth for at least 30 seconds)
15863734|NCT03932292|Drug|Supersaturated solution of calcium and phosphate ions|According to medical prescription of the instruction for use under consideration (4 times a day).
15863735|NCT03932266|Drug|Endostar|Endostar, 15 mg/m2, continous intravenous infusion, 3 cycles during induction chemotherapy, 4 cycles during concurrent chemoradiotherapy.
15863736|NCT03932266|Drug|Cisplatin|Cisplatin, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy; Cisplatin, 80 mg/m2, intravenous infusion, 2 cycles during concurrent chemoradiotherapy.
15863737|NCT03932266|Drug|Docetaxel|Docetaxel, 75 mg/m2, intravenous infusion, 3 cycles during induction chemotherapy.
15863738|NCT03932266|Radiation|Intensity Modulated Radiation Therapy (IMRT)|IMRT: 66 Gy, 2-2.2 Gy per fraction, a total of 33 fractions
15863739|NCT03932253|Drug|FCN-159|Administered orally once a day
15863740|NCT03932240|Drug|Fibrinogen Concentrate (FC)|The dose of fibrinogen concentrate will be calculated to achieve a level of 300mg/dL after drug administration.
15863741|NCT03932240|Drug|Cryoprecipitate|Standard transfusion algorithm includes two units of cryoprecipitate, which result in a median post-operative fibrinogen level of 345mg/dL
15863742|NCT03932227|Device|Cardioskin|Subjects will have a 24h recording with Cardioskin, next will be unequipped.
15863743|NCT03932227|Device|Holter|Subjects will have a 24h recording with Holter, next will be unequipped.
15863744|NCT03932214|Device|ACCUVEIN|The nurse uses the Accuvein® device to identify the veins before puncture and then proceeds as usual, under illumination of the device.
15863745|NCT03932201|Drug|Damoctocog alfa pegol (Jivi, Bay94-9027)|Follow clinical practice. BAY94-9027 is a B-domain-deleted recombinant factor VIII (rFVIII) product site-specifically conjugated to a single (dual 30-kDa branched) 60-kDa polyethylene glycol (PEG) molecule. BAY 94-9027 is intended for prophylaxis and treatment of bleeds in patients with hemophilia A aged ≥12 years, with a narrow, predictable weekly dose that allows for the treatment regimen to be tailored to individual patient needs.
15863746|NCT03932188|Behavioral|Mental Health Assessments and Computerized Cognitive Test|Participants will be asked to complete questionnaires and will be asked questions that address a broad range of personal life experiences involving social, occupational, domestic, and other behaviors.
15863747|NCT03932188|Device|MRI scan|Up to two MRI scan sessions will be done, altogether totaling just under 3 hours of scanning. MR scanners measure brain anatomy and activity using very strong magnets. No X-rays or radiation are involved.
15863748|NCT03932175|Behavioral|Intervention group|Behaviorial intervention on non-invasive ventilation use and adherence alongside lifestyle changes recommendations supported by an mHealth tool (MyPathway app)
15863749|NCT03932162|Drug|Insulin-Like Growth Factor 1|Growth factor protein
15863750|NCT03932162|Other|No Insulin-Lie Growth Factor 1|No Insulin-Like Growth Factor 1 will be given.
15863751|NCT03932149|Device|Intermittent Theta Burst Stimulation (iTBS)|The target is left DLPFC and the iTBS protocol is: 70% of RMT; triplet 50 Hz bursts, repeated at 5 Hz; 2s on and 8s off; 600 pulses a session.
15863752|NCT03932149|Device|Sham stimulation|The target is right DLPFC and the sham stimulation protocol is: triplet 50 Hz bursts, repeated at 5 Hz; 2s on and 8s off; 600 pulses a session.
15863753|NCT03932136|Dietary Supplement|Sulforaphane|Sulforaphane (SFN) is a natural compound extracts from cruciferous vegetables, especially broccoli, with cytoprotective, anti-inflammatory, and antioxidant effects.
15863754|NCT03932136|Combination Product|Placebo|The placebo is safe, with no therapeutical effect, and has same appearance and similar smell and taste with active tablet.
15863755|NCT03932123|Drug|Piperacillin and tazobactam, azlocillin, latamoxef, meropenem, vancomycin，cefotaxime|Efficacy and safety of antibiotics
15863756|NCT03932110|Diagnostic Test|omentin, visfatin|diagnostic blood test
15863757|NCT03932097|Behavioral|Parenting Now|Preventive Parenting Now digital intervention emphasizing parent-teen/young adult communication on drinking/risks of drinking/risks of alcohol abuse, with the addition of a communication component on the risks of nicotine and marijuana use, with the goal of reducing alcohol, nicotine and marijuana use in college students.
15863758|NCT03932097|Other|Active Control Materials|SAMHSA alcohol prevention materials for parents
15863759|NCT03932084|Behavioral|Control group|"During hospitalization:
~Monitor subjects' blood glucose;
~One-on-one education: Education includes skills related to diabetes self-management, basic knowledge of diabetes, diet, exercise, medication, blood glucose monitoring, risks of glucose fluctuations;
~Teaching patients and their families to use blood glucose meters and correctly record results. The diabetes specialist nurses demonstrate correct methods for self-monitoring blood glucose.
~During discharge: Patients were given standard hospital discharge instructions and were asked to monitor their blood glucose 5 times daily after discharge.
~Follow-up: If a patient FPG was less than 7 mmol/L, 2hPG was less than 10 mmol/L, or A1c was less than 7%, no intervention would be implemented. If one of these items was above the numbers, a referral would be made to an endocrinologist for medication adjustment. Participants received telephone follow-up one week after discharge, thereafter, follow-up were conducted once a month."
15863760|NCT03932084|Behavioral|Glucose fluctuation targeted intervention|We set achieving goals for this intervention group (both A1c<7% and LAGE<80mg/dl). Participants received the same usual care as the control group; though additional attention was paid to glucose fluctuation on the basis of glucose control. Even the patient's FPG, 2hPG, and A1c were all well controlled, If his or her LAGE≥80mg/dl, we would carefully assess the patient's diet and exercise and daily activities first. If it was caused by lifestyle or events, the researchers worked with patients to find a self-care behavioral solution for the glucose fluctuation, and set behavioral goals, otherwise, the researchers would refer the patient to an endocrinologist for medication adjustment. During next follow-up, we evaluated the glucose fluctuation and target completion.
15863761|NCT03932071|Drug|Zoledronic Acid|
15863762|NCT03932058|Drug|Chemotherapy|all osteosarcoma patients will give regular chemotherapy for osteosarcoma, the protocol is the same as Methotrexate+Doxorubicin+Cisplatin.
15863763|NCT03932045|Device|SYB Filler (SF-01)|Apply up to 1.0 ml of the test device (SF-01) and the contrast device (Ellansé M) to both sides of the nasolabial fold.
15863764|NCT03932045|Device|Ellansé M|Apply up to 1.0 ml of the test device (SF-01) and the contrast device (Ellansé M) to both sides of the nasolabial fold.
15863765|NCT03932032|Behavioral|Attention Bias Modification Treatment|At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in social anxiety.
15863766|NCT03932032|Behavioral|Neutral Control Task|At each of eight sessions, participants complete 160 computer administered trials wherein a pair of neutral stimuli is presented simultaneously and then followed immediately by a probe. NCT matches ABMT on duration, format, and number of trials, but does not engage attention to social threat and does not train attention.
15863767|NCT03932019|Drug|Jitongning tablet|Jitongning tablet,3tablets,bid,treat 12 weeks
15863768|NCT03932019|Drug|Jitongning tablet,Jitongning tablet placebo|Jitongning tablet,2tablets,bid,treat 12 weeks Jitongning tablet placebo,1tablet,bid,treat 12 weeks
15863769|NCT03932019|Drug|Jitongning tablet placebo|Jitongning tablet placebo,3tablets,bid,treat 12 weeks
15863770|NCT03932006|Drug|Fengshigutong Capsule plus Imrecoxib|Fengshigutong Capsule 1.2g twice a day,Imrecoxib 0.1g twice a day,orally
15863771|NCT03932006|Drug|Fengshigutong Capsule|Fengshigutong Capsule 1.2g twice a day,orally
15863772|NCT03932006|Drug|Imrecoxib|Imrecoxib 0.1g twice a day,orally
15863773|NCT03931993|Biological|Placebo comparator|
15863774|NCT03931993|Biological|Grass MATA MPL|
15863775|NCT03931980|Procedure|Robotic-assisted rectal cancer resection and Laparoscopic rectal cancer resection|we perform robotic surgery using the da Vinci Robot System Si version and laparoscopic surgery to treat rectal cancer
15863776|NCT03931967|Diagnostic Test|MR-proADM|to evaluate the plasmatic level of MR-proADM and endothelin-1 in the first five days of ICU stay.
15863777|NCT03931941|Drug|RBX2660|RBX2660 is a microbiota suspension administered as an enema
15863778|NCT03931928|Drug|(Z)-Endoxifen supplementation according to genotype|Group 2: CYP2D6 genotype predicted intermediate metabolizer receive 1.5 mg, poor metabolizer receive 3 mg (Z)-Endoxifen and extensive or ultrarapid metabolizer receive 0 mg endoxifen (Placebo)
15863779|NCT03931928|Drug|(Z)-Endoxifen supplementation according to plasma levels|Group 3: Patients will receive (Z)-endoxifen according to (Z)-endoxifen steady state plasma concentrations (phenotype) at screening (i.e. ≤ 15 nM receive 3 mg, > 15 and ≤ 25 nM receive 1.5 mg (Z)-Endoxifen and > 25 nM receive 0 mg (Placebo)
15863780|NCT03931915|Drug|TAK-385|TAK-385 40 mg tablets + Leuprorelin acetate placebo injection
15863781|NCT03931915|Drug|Leuprorelin acetate|TAK-385 placebo tablets + Leuprorelin acetate 1.88 mg / 3.75 mg injection
15863782|NCT03931902|Device|intubation with Endotracheal tube|After masking ventilation with sevoflurane till the adequate anesthetic depth, intubation will be done with endotracheal tube (ETT).
15863783|NCT03931902|Device|intubation with laryngeal mask airway|After masking ventilation with sevoflurane till the adequate anesthetic depth, intubation will be done with laryngeal mask airway (LMA).
15863784|NCT03931889|Dietary Supplement|Vitamin D3|Cap. Cholecalciferol 40,000 IU
15863785|NCT03931876|Drug|Placebos|Single ascending dose administration
15863786|NCT03931876|Drug|AV-006|Single ascending dose administration
15863787|NCT03931863|Drug|Ondansetron 4mg|Intravenous administration of ondansetron 4mg diluted in 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia.
15863788|NCT03931863|Drug|Ondansetron 8mg|Intravenous administration of ondansetron 8mg diluted in 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia.
15863789|NCT03931863|Drug|100ml normal saline 0.9 percent|Intravenous administration of 100ml of normal saline 0.9 percent within 10 minutes prior to spinal anesthesia.
15863790|NCT03931850|Procedure|Pudendal nerve block|Pudendal nerve block is the one of peripheral nerve block. Injection local anesthetic medication around this nerve can provide analgesia around perineal area.
15863791|NCT03931837|Device|Tourniquet: Systolic blood pressure + 75 mmHg|Spinal block without morphine. Medial parapatellar approach. Same posterior stabilized design and operated by a single surgeon. Drug: Peri-articular Transmine(15 mg/kg) combined with multimodal local anesthetic infiltration (0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg) mixed NSS up to 75 mL. Procedure/Surgery: TXA combined with multimodal local anesthetic infiltration inject into peri-articular area (Anterior soft tissue 25 mL+Medial gutter area 25 mL+Lateral gutter area 25 mL) prior to capsular closure and tourniquet deflation
15863792|NCT03931837|Device|Tourniquet: Systolic blood pressure + 100 mmHg|Spinal block without morphine. Medial parapatellar approach. Same posterior stabilized design and operated by a single surgeon. Drug: Peri-articular Transmine(15 mg/kg) combined with multimodal local anesthetic infiltration (0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg) mixed NSS up to 75 mL. Procedure/Surgery: TXA combined with multimodal local anesthetic infiltration inject into peri-articular area (Anterior soft tissue 25 mL+Medial gutter area 25 mL+Lateral gutter area 25 mL) prior to capsular closure and tourniquet deflation
15863793|NCT03931837|Device|Tourniquet: Systolic blood pressure + 150 mmHg|Spinal block without morphine. Medial parapatellar approach. Same posterior stabilized design and operated by a single surgeon. Drug: Peri-articular Transmine(15 mg/kg) combined with multimodal local anesthetic infiltration (0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg) mixed NSS up to 75 mL. Procedure/Surgery: TXA combined with multimodal local anesthetic infiltration inject into peri-articular area (Anterior soft tissue 25 mL+Medial gutter area 25 mL+Lateral gutter area 25 mL) prior to capsular closure and tourniquet deflation
15863819|NCT03931577|Procedure|Communication skill enhancement|Continuous (on-site and monthly online training) illness-focused intervention (enhancement of communication skills to optimise doctor-patient consultations and share decision making with the aid of patient-centred leaflets) in the primary care practices.
15863820|NCT03931564|Procedure|PRESERFLO Microshunt implantation|The intervention consists of the microshunt implantation augmented with mitomycin C application.
15863821|NCT03931564|Procedure|Trabeculectomy|The usual care / control group will undergo a standard fornix based trabeculectomy augmented with mitomycin C application.
15865786|NCT03915600|Other|Quinoa and Flaxseed|personalized diet added with quinoa and flaxseed
15863794|NCT03931824|Other|PRP|"A venous blood sample of 8.5 ml were obtained from patients. For the study group, the blood samples were mixed with 1.5 ml ACD-A or sodium citrate to achieve anticoagulation. Resulting material was then centrifugated for 5 minutes with RCF 1200 G speed to clump erythrocytes, and then centrifugated for 10 minutes in same speed to obtain thrombocyte concentrate. 2 ml's of the platelet rich plasma was injected to the shoulder of the subjects. For the sham injection group, same amount of blood was taken and they were given a of waiting time of same duration with the study group, with the resulting preparate being 2 ml's of 0,9% saline instead. PRP solutions were prepared with kits of Easy PRP(Neotec Biotechnology, Istanbul, Turkey).
~Injections were done every two weeks, for a total of 3 times. 21 G injection needles with injection technique of posterior approach were used(18, 19). To provide blindness, all injections were done using injectors coated with non transparent tape."
15863795|NCT03931824|Other|Exercise|All of the patients were also informed about proper positioning and the standard care for the affected extremity. Their process of neurological rehabilitation was not changed, which was 5 days of the week, one session of 45 minutes a day. They were also given a program of standardized ROM exercises, which included passive and active motions.
15863796|NCT03931811|Device|Short wave diathermy|SWD group took short wave diathermy with specifications of 400 watt power output, 27.12 MHz frequency, 11.06m wave length, using condensators and electrodes of 12 cm diameter parallel to the knee for 20 minutes(Enraf-Nonius, Curapuls 970 Short wave diathermy device).
15863797|NCT03931811|Other|Prolotherapy|Prolotherapy solutions were injected to the knee by a blinded physician in the group, using 25 gauge needle, with solutions being 6 ml 25 % dextrose (3 ml 20% dextrose + 3 ml 30% dextrose) for intraarticular, and 20 ml 15% dextrose (10 ml 0,9% NaCl + 10 ml 30% dextrose) for periarticular. Injection points wwere defined as medial collateral ligaments, adhesion points of quadriceps tendon, adhesion points of patellar tendon, tuberositas tibia, pes anserinus, lateral collateral ligaments, coronal ligaments, medial and lateral tibia plateaus. Patients were blinded to their treatment groups
15863798|NCT03931798|Diagnostic Test|Visual Scanning Test|The Visual Scanning Test (VST) involved a visual search for a target between similar visual distractors, projected in the far space, so as to simulate the search within a visual field. It is overall composed by four trials, each trial contained 20 cases and made up by 20 stimuli. On about the 80% of cases, the test provided the presence of target in the left, center or in right hemispace. In the remaining 20% of cases, the test provided the presence of a catch trial (absence of the target), to assess the presence of frontal disturbances or malingering. The test is constructed according to an increasing attentional load for the target on the left-hemispace. Participants, sitting in front a blank wall, were required to actively and free explore the projected visual field to search for the visual target, naming its identification (saying YES or NO). During the task, the examiner annotated the reaction times and the errors.
15863799|NCT03931785|Drug|MD-7246|Oral tablet
15863800|NCT03931785|Drug|Placebo|Matching oral tablet
15863801|NCT03931772|Behavioral|Automated Self-Hypnosis|Hypnosis is a very safe and validated mind-body technique for symptom management of various clinical problems. The intervention is designed by the protocol's principal investigator, Dr. David Spiegel.
15863802|NCT03931759|Diagnostic Test|laparoscopic surgery|patients with diabetes mellitus in laparoscopic surgery
15863803|NCT03931746|Device|Porcine xenograft|The EZ-DERM™ porcine xenograft is a biosynthetic dressing made from porcine collagen containing aldehyde crosslinking. It has been most commonly applied to the management of 2nd degree burns, both partial-thickness and full-thickness defects. This dressing can be used for two healing purposes, either for primary healing or as an intermediate in the preparation for a skin graft
15863804|NCT03931733|Other|Music Therapy|Single thirty minute receptive music therapy intervention.
15863805|NCT03931720|Biological|BiCAR-NK/T cells (ROBO1 CAR-NK/T cells)|The subject will be observed for any side effects during this time and all the adverse events will be recorded.
15863806|NCT03931707|Genetic|Genomic sequencing|Both sick and high-risk newborn un-randomized to receive genomic sequencing will receive a Genomic Newborn Sequencing Report which will include pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease.
15863807|NCT03931694|Device|e-DOL|e-health program (smartphone and web platform)
15863808|NCT03931681|Drug|OKI-179|OKI-179 single agent
15863809|NCT03931668|Drug|TPN-672|single dose of TPN-672 maleate tablet
15863810|NCT03931655|Diagnostic Test|Spectroscopic photoacoustic imaging|Spectroscopic photoacoustic imaging uses a laser that is pulsed for a nanosecond, applying laser light to the patient's skin. Hemoglobin and melanin absorb the laser's energy and convert it to heat, which rapidly expands local tissue and produces a broadband ultrasound wave and is detected with a clinical ultrasound transducer. Because the signal is proportional to the optical absorption in tissue, high resolution images of the lymph nodes can be acquired from the detected ultrasound waves, and can be used to measure saturated oxygen in the nodes.
15863811|NCT03931642|Drug|RCHOP|"D1 : Rituximab 375 mg/m² IV + Cyclophosphamide 750 mg/m² IV + Doxorubicin 50 mg/m² IV + Vincristine 1.4 mg/m² IV.
~From D1 to D5 : Prednisone 60 mg/m² PO."
15863812|NCT03931642|Drug|Blinatumomab|Blinatumomab by continuous vein infusion
15863813|NCT03931629|Procedure|CONVENTIONAL PHACO|Cataract surgery by means of Femtosecond Laser-Assisted Cataract Surgery,
15863814|NCT03931616|Procedure|STEMO|STEMO, the intervention, includes prehospital neurological emergency assessment with the option to perform CT and CT-angiography, start specialized treatment at the door-step of the patient's house, including thrombolysis with tissue Plasminogen Activator and blood pressure management (choice of drug at discretion of treating physician), use of telemedicine for image transfer as well as results of point-of-care laboratory, prenotification (e.g. for endovascular treatment), triage and transport.
15863815|NCT03931616|Procedure|Regular care|A regular ambulance, the comparator, not equipped with advanced point-of-care laboratory or CT scanner, without telemedicine and not staffed with a neurologist.
15863816|NCT03931603|Other|MRI|MRI protocol associating sagittal and axial (+/- coronal) sequences in T2 + / - turbo spin T1 weighting with fat saturation.
15863817|NCT03931590|Drug|[14C]-Omaveloxolone|[14C]-Omaveloxolone 50 mg capsules
15863818|NCT03931577|Diagnostic Test|C-reactive protein rapid testing|Continuous (workshop and monthly web-based training) disease-focused intervention with the provision of CRP rapid testing in the primary care practices.
15863912|NCT03930758|Combination Product|Behavior intervention of downhill exercise|40 minutes of downhill exercise
15863822|NCT03931551|Drug|Olaparib [Lynparza®] plus Trastuzumab [Herceptin®]|Participants will receive olaparib (300 mg tablets, orally twice daily during 21-day cycles) in combination with herceptin (intravenous dose of 4 mg/kg body weight with subsequent weekly doses of 2 mg/kg or subcutaneous dose of 600 mg every 3 weeks) until progression or unacceptable toxicity.
15863823|NCT03931538|Diagnostic Test|Guidance 4.0 PCR test|All patients will have a urine culture and Guidance 4.0 PCR test run on their urine, but physicians will receive one or the other, or both depending on the treatment arm.
15863824|NCT03931538|Diagnostic Test|Urine Culture|All patients will have a urine culture and Guidance 4.0 PCR test run on their urine, but physicians will receive one or the other, or both depending on the treatment arm.
15863825|NCT03931525|Device|Fractitional Radiofrecuency with Drug Delivery|Electromagnetic energy within the spectrum of radio frequencies applied to the skin whose purpose is to generate thermal effects and which will be complemented with a skin drug
15863826|NCT03931525|Device|Fractitional Radiofrecuency|Electromagnetic energy within the spectrum of radio frequencies applied to the skin whose purpose is to generate thermal effects
15863827|NCT03931512|Device|transcranial direct current stimularion|aplication of direct current stimulation on the scalp wiht sponge electrodes
15863828|NCT03931499|Diagnostic Test|Metabolomic analysis|Blood will be collected in all patients blood before surgery and after surgery (postoperative day 1). Our study is based on a polar metabolomics profiling of plasma and/or serum using hybrid triple quadrupole mass spectrometer coupled with chromatographic system.
15863829|NCT03931473|Other|Bed nets|Next-generation bed nets combining insecticides with different modes of action or a standard pyrethroid bed net
15863830|NCT03931460|Drug|Medical Abortion|Medical Abortion
15863831|NCT03931447|Biological|JNJ-72537634|Participants in Cohort 1 and 3 will receive Dose 1 and participants in Cohort 2 and 4 will receive Dose 2 of JNJ-72537634 as oral capsule.
15863832|NCT03931447|Biological|Placebo|Participants will receive matching placebo as oral capsule in all cohorts.
15863833|NCT03931434|Dietary Supplement|Aged Garlic Extract (AGE)|2400mg of Aged Garlic Extract (AGE)
15863834|NCT03931434|Dietary Supplement|Placebo|Placebo
15863835|NCT03931421|Biological|CAR-T treatment|a novel method for treatment of multiple myeloma, in which patients' T cells are engineered into B Cell Maturation Antigen（BMCA）-Targeted CAR-T cells to eliminate myeloma cells.
15863836|NCT03931408|Drug|Gentamicin Sulfate|Gentamicin will be compounded for immediate use in single-dose, disposable BD 50ml Luer-Lok tip syringes. The container closure system for the diluted gentamicin sulfate solution and saline solution will be sterile and processed with depyrogenation. The solution will be slowly infused into the bladder after drainage of urine is complete. While monitoring blood pressure, the solution will remain in the participant's bladder for a least 30 minutes (unless the participant is experiencing autonomic dysreflexia, and in that case, immediately drained) with the goal of attaining 2 hours.
15863837|NCT03931408|Other|Placebo instillation (saline alone)|Saline will be compounded for immediate use in single-dose, disposable BD 50ml Luer-Lok tip syringes. The container closure system for the diluted gentamicin sulfate solution and saline solution will be sterile and processed with depyrogenation. The solution will be slowly infused into the bladder after drainage of urine is complete. While monitoring blood pressure, the solution will remain in the participant's bladder for a least 30 minutes (unless the participant is experiencing autonomic dysreflexia, and in that case, immediately drained) with the goal of attaining 2 hours.
15863838|NCT03931408|Other|No instillation|Participants will not receive an instillation of gentamicin or saline alone, but instead will continue standard of care. Participants will be assessed at the pre-, mid- and post-intervention time points.
15863839|NCT03931395|Dietary Supplement|Honey|Will give patients and families included in the honey standard of care group 40 packets of hospital approved honey to implement in the tonsillectomy post-operative care of the child
15863840|NCT03931395|Other|Standard of Care|Patients will receive standard post operative medications per surgeon
15863841|NCT03931382|Behavioral|Virtual Reality|The VR intervention is underpinned by experiential learning and social cognitive theory, such that user will observe successful performance and simulation to encourage imitation and reinforce success in the assessment. All participants will be undergoing a simulation assessment with the head coil.
15863842|NCT03931382|Behavioral|Simulator Preparation|The mock MRI is provided by the Child Life Specialist, according to the current care plan which consists of exposing children to the MRI simulator, medical devices, and procedures. The mock MRI is located within the medical imaging facility. All participants will be undergoing a simulation assessment with the head coil.
15863843|NCT03931382|Behavioral|Preparation Booklet for Non-Sedated MRI|The standard MRI preparation booklet provides access to a series of printed photos and text showing the MRI experience step-by-step to help prepare for MRI. All participants will be undergoing a simulation assessment with the head coil.
15863844|NCT03931369|Drug|Tolvaptan 15 MG|Single administration of one pill of 15 MG tolvaptan
15863845|NCT03931356|Other|Pulmonary function tests|analysis of lung volume and diffusion capacity
15863846|NCT03931343|Procedure|Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidance|Thoracolumbar interfascial plane block: Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between multifidus and longissimus muscle with USG guidance
15863847|NCT03931343|Procedure|Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidance|Erector spinae plane block: Bilateral 20 ml 0.25 % Bupivacaine with 2mg preservative free dexametasone and 5mcg/ml epinephrine injected between the erector spinae muscles and transverse process with USG guidance
15863848|NCT03931330|Device|Percutaneous neurostimulation|Percutaneous neurostimulation using NSS-2 Bridge device
15863849|NCT03931317|Drug|Latanoprostene bunod 0.024% QD|This is a randomized, single-center, investigator-masked, 2-period, 8-week treatment study with washout and crossover between treatment periods. There will be 2 treatments in this study: latanoprostene bunod 0.024% QD and timolol maleate 0.5% BID.
15863850|NCT03931317|Drug|Timolol maleate 0.5% BID|This is a randomized, single-center, investigator-masked, 2-period, 8-week treatment study with washout and crossover between treatment periods. There will be 2 treatments in this study: latanoprostene bunod 0.024% QD and timolol maleate 0.5% BID.
15863851|NCT03931304|Procedure|Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure|Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure
15863852|NCT03931291|Drug|APR-246|APR-246 will be administered on Days 1-4, with azacitidine on Days 1-5, of every 28 day cycle. Patients may receive a maximum of 12 cycles.
15863853|NCT03931278|Other|learning and recall of a sequence of body movements|The objective of this study to investigate, if learning and recall of a sequence of body movements (steps that realize a pattern on the ground) can be improved by self-produced music (having particular melodic-structures in relation to the pattern), compared to the same sound (a single tone) for each pattern in persons
15863854|NCT03931265|Diagnostic Test|ketohexokinase|Check the isoforms of ketohexokinase in the specimen of endometrial cancer
15863855|NCT03931252|Dietary Supplement|Boost VHC|8 ounce can liquid meal, calories 530kcal, Carbohydrate 46g, Protein 22g, Fat 30g
15863856|NCT03931252|Dietary Supplement|Ensure High Protein|8 ounce can liquid meal, calories 160kcal, Carbohydrate 13g, Protein 16g, Fat 2g
15863857|NCT03931239|Biological|Study subjects will be vaccinated with 3 (three) vaccine doses. The first vaccine will be administered intramuscularly starting at 6-12 weeks of age followed by two doses at four-week interval|An openlabel, multicentric, bridging study to assess the safety of Diphtheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influenzae type b Conjugate Vaccine (Adsorbed) manufactured by Serum Institute of India Pvt. Ltd in Vietnamese infants aged 6-12 weeks, given as a 3-dose regime, with 4 week intervals between the doses
15863858|NCT03931226|Drug|Drug consumption|number of Daily Defined Doses (DDDs) of medications prescribed and given to children in connection with the indication of the spa treatment
15863859|NCT03931187|Behavioral|Cognitive progressive muscular relaxation therapy|This therapy combines cognitive psychotherapy and progressive muscular relaxation, intervened 6 times with 1-1.5 hour each time. The whole therapy will last round 20-30 days during IVF-ET.
15863860|NCT03931174|Behavioral|Addiction Technology Transfer Center (ATTC) Training Strategy|Participating organizations will receive training consisting of 3 components: 1) didactic workshop - full-day workshop led by a contingency management (CM) expert for both CM staff and leaders, 2) performance feedback - submission of CM session recordings for review and performance feedback at least monthly for 9 months for CM staff, and 3) staff coaching - monthly provider coaching calls led by a CM expert for 9 months for both CM staff and leaders.
15863861|NCT03931174|Behavioral|Enhanced Addiction Technology Transfer Center (E-ATTC) Training Strategy|Participating organizations will receive all of the elements of the ATTC control condition. In addition, organizations will receive two additional elements: 1) Implementation Sustainment Facilitation - monthly coaching calls for CM leaders and staff focused on sustainment, 2) Pay for Performance - participating CM staff will have the opportunity to earn monthly monetary bonuses for achieving pre-defined implementation goals for 9 months.
15863862|NCT03931161|Drug|Evolocumab Auto-Injector [Repatha]|Auto-Injector, 140 mg every two weeks.
15863863|NCT03931161|Drug|Placebo Auto-Injector|Matching Placebo for the active comparator (Evolocumab)
15863864|NCT03931148|Diagnostic Test|Geriatric Assesment with neuropsychological test more specific on decision making|The following tests will be made : MoCA, FAB, TMT, Stroop-Victoria, JAT
15863865|NCT03931148|Diagnostic Test|Functional RMI|With specific test of decision making (IGT) specially adapted to the population
15863866|NCT03931148|Diagnostic Test|High Resolution EEG|With specific test of decision making (BART) specially adapted to the population
15863867|NCT03931148|Other|Qualitative interview|Qualitative semi-directed interviews with participants, their caregivers and their geriatrician to analyse everyday life decision making ability.
15863868|NCT03931135|Drug|IV Cyclizine versus IV Dexamethasone for prevention of nausea and vomiting after intrathecal morphine in patients undergoing cesarean section|"The first group (Dexamethasone) will receive 8 mg IV dexamethasone within 1-2 minutes after the umbilical cord is clamped.
~The second group (Cyclizine) will receive 50 mg cyclizine within 1-2 minutes after the umbilical cord is clamped"
15863869|NCT03931122|Device|Ear Size Based Method (Ambu® AuraOnce™ Laryngeal Mask Airway)|"The Laryngeal Mask Airway (LMA) is one of the devices used to maintain airway during general anesthesia. Its appropriate size is selected according to patients body weight as recommended by the manufacturer.
~However its appropriate size can also be selected via several other methods and one of them is patients external ear size. In this study the investigators will compare external ear size based method for LMA selection with the standard weight based method for LMA size selection.
~Vertical Ear length: will be measured from the most dependent portion of the lobule to the furthest portion of the auricle.
~Horizontal Ear length (width): from the tragus to the furthest part of the helix horizontally.
~Dimension(cm2): Vertical length (L) × Horizontal length (width-W)
~LMA Size LMA Cuff Length (cm) corresponding to vertical ear length.
~LMA Cuff Width (cm) corresponding to horizontal ear width."
15863870|NCT03931096|Other|Quality of life questionnaire|Self and proxy PedsQL 4.0 questionnaires.
15863871|NCT03931083|Diagnostic Test|Screening for CIN2+/HSIL|The investigators will compare three different screening methods: visual assessment with portable magnification device , visual inspection after application of acetic acid, screening for high risk variants of HPV. All patients will receive cervical biopsies and histopathological examination.
15863872|NCT03931070|Drug|Ramelteon|Nightly administration of Ramelteon 8 mg
15863873|NCT03931070|Drug|Placebo - Cap|Nightly administration of Placebo capsule, which is indistinguishable from Ramelteon
15863874|NCT03931057|Drug|ADV6209 (=gamma-cyclodextrin-Midazolam)|30 min. before anesthesia children have to swallow the anxiolytic drug (ADV6209)
15863875|NCT03931057|Drug|Midazolam|30 min. before anesthesia children have to swallow the anxiolytic drug Midazolam
15863876|NCT03931044|Procedure|Image-Guided Robotic Gastrectomy|The near-infrared technology, integrated in the robotic camera, will be used to detect fluorescent lymphonodes.
15863877|NCT03931031|Diagnostic Test|Quantra System|Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care
15863878|NCT03931018|Other|Alcohol|Administration of one dose of alcohol among two possible different doses (in males) or only one possible dose (in females) simulating a binge drinking episode under experimental conditions.
15863913|NCT03930758|Combination Product|Dietary intervention of exercise before the meal|40 minutes of downhill exercise completed 1 hour before the meal
15863914|NCT03930758|Combination Product|Behavioral intervention of downhill exercise|40 minutes of downhill exercise
15863879|NCT03931005|Other|Collaboration Decision Support Guide|Electronic toolkit intended to help organizational leaders select partners and negotiate partnerships for implementation. This will contain: 1) a brief summary of collaboration approaches associated with implementation, 2) detailed descriptions of collaboration strategies, 3) a decision analysis tool that guides the selection of collaborative strategies given the community context, and 4) sample contract or agreement language that specifies the nature of the partnership and expectations.
15863880|NCT03931005|Other|General Collaboration Support|Electronic description of collaborative implementation strategies and their definitions.
15863881|NCT03930992|Drug|Colaren in HIV positive|1 Arm (HIV+): will receive Zoledronic acid 4mg and colaren ® (vitamin D, magnesium, phosphate, calcium).
15863882|NCT03930992|Drug|standard treatment in HIV positive|2 Arm (HIV+): will receive Zoledronic acid 4mg and standard treatment (vitamin D and calcium carbonate)
15863883|NCT03930992|Drug|Colaren in HIV negative|3 Arm (HIV-): will receive Zoledronic acid 4mg and colaren ® (vitamin D, magnesium, phosphate, calcium).
15863884|NCT03930992|Drug|standard treatment in HIV negative|4 Arm (HIV-): will receive Zoledronic acid 4mg and standard treatment (vitamin D and calcium carbonate)
15863885|NCT03930966|Diagnostic Test|PDEQ, PCL-5 and demographic survey|Questionnaires
15863886|NCT03930953|Drug|CC-99282|CC-99282
15863887|NCT03930953|Drug|rituximab|rituximab
15863888|NCT03930940|Device|remote ischemic conditioning|RIC is a non-invasive therapy that performed by an electric autocontrol device with cuffs placed on arm and inflated to 200 mmHg for 5-min followed by deflation for 5-min, the procedures is performed repeatedly for 4 to 5 times.
15863889|NCT03930940|Other|Regular treatment|Regular treatment is based on associated guidelines for ICH.
15863890|NCT03930927|Drug|Self Assembling peptide|enamel regeneration
15863891|NCT03930927|Drug|remineralizing agent|enamel regeneration
15863892|NCT03930914|Device|Parasym (TM) Transcutaneous Electrical Nerve Stimulation (TENS) Device|Daily use of Parasym (TM) device on tragus or ear lobe, as assigned treatment arm
15863893|NCT03930901|Other|Health education learning package|Health education learning package (HELP) was introduced to children in the selected schools. The package involved different items and activities during the study period, e.g. comic booklet on the intestinal parasitic infections, stand banners, posters, lectures, songs, drawing competition, puppet show, lectures, with a toolkit that involved soap, slipper (plastic clogs shoes), & nail clipper).
15863894|NCT03930888|Dietary Supplement|Dietary supplement|Patients with preoperative nutritional support with special nutritional supplements vs. patients without special nutritional support.
15863895|NCT03930875|Other|Aspirin Resistance testing|Aspirin resistance will be measured using platelet aggregometry (VerifyNow assay)
15863896|NCT03930862|Device|Locator Attachment (positioner)|intra oral attachment
15863897|NCT03930849|Behavioral|AIMS|Participants randomized to the AIMS arm be enrolled in VA's Annie text messaging program and receive the study protocol. Annie text messages will ask the participate to provide feedback about specific domains related to their depression treatment and goals. The Veteran participant will receive a weekly report about their Annie responses through My HealtheVet, VA's patient portal, and instructed to share information with their care team at their next scheduled appointment. In addition, a summary of response will be provided to the participant's clinician prior to their appointment(s) during the studies 12 week time frame.
15863898|NCT03930849|Behavioral|AIMS plus|Participants randomized to the AIMS Plus arm will receive a weekly phone call in addition to being enrolled in VA's Annie text messaging program/study protocol. Annie text messages will ask the participate to provide feedback about specific domains related to their depression treatment and goals. The Veteran participant will receive a weekly report about their Annie responses through My HealtheVet, VA's patient portal, and instructed to share information with their care team at their next scheduled appointment. In addition, a summary of response will be provided to the participant's clinician prior to their appointment(s) during the studies 12 week time frame.
15863899|NCT03930836|Behavioral|Hand Arm Bimanual Intensive Therapy Including Lower Extremities|Intensive intervention focusing on a constant bimanual coordination with a lower extremities and trunk control stimulation during play and functional activities. 50% of therapeutic time will be performed using the new interactive interface
15863900|NCT03930836|Behavioral|Conventional physical and occupational therapy|Conventional therapy (physical and occupational therapy) is mainly based on neurodevelopmental therapeutic principles. 50% of therapeutic time will be performed using the new interactive interface
15863901|NCT03930823|Other|Interview|One to one interview
15863902|NCT03930810|Procedure|Surgical biliary diversion|Surgical interruption of enterohepatic circulation
15863903|NCT03930797|Behavioral|Intimacy Enhancement|The IE intervention is grounded in cognitive behavioral couple therapy and sex therapy, and includes education and skills training with a focus on the following major topics: understanding effects of breast cancer on sex and intimacy; goal-setting; communication skills; problem-solving and engaging in activities to build intimacy; identifying and restructuring negative or inflexible thoughts; and planning ahead and preparing for challenges. Participants will be asked to participate in written and behavioral activities at home between sessions to strengthen skills acquisition.
15863904|NCT03930797|Behavioral|Living Healthy Together|The Living Healthy Together (LHT) intervention focuses on delivering education and support to breast cancer survivors and their partners across a range of topics including social support, sleep and fatigue, stress and stress management, nutrition, and physical activity. Participants will be asked to engage actively with the material and to review readings and intervention material between sessions.
15863905|NCT03930784|Other|Nil intervention|
15863906|NCT03930771|Drug|Capecitabine|1500mg/m2 orally per day (divided into two doses with maximum daily dose of 2500mg) on days 1 through 14.
15863907|NCT03930771|Drug|Temozolomide|150 to 200 mg/m2 orally on days 10 through 14.
15863908|NCT03930758|Combination Product|Behavior intervention of uphill exercise|40 minutes of uphill exercise
15863909|NCT03930758|Combination Product|Dietary intervention of exercise before the meal|40 minutes of uphill exercise completed 1 h before the meal
15863910|NCT03930758|Combination Product|Dietary intervention of uphill exercise|40 minutes of uphill exercise
15863911|NCT03930758|Combination Product|Dietary intervention of exercise after the meal|40 minutes of uphill exercise started 1 hour after gthe meal
15880246|NCT03803202|Biological|PPSV23|Intramuscular Injection
15863925|NCT03930719|Diagnostic Test|Stroke screening tools|"Patients are evaluated for the presence of PSD using DSM-5 criteria (gold standard). Established delirium detection tools are evaluated for their diagnostic accuracy compared to the gold standard."
15863926|NCT03930706|Other|Longer administration of estradiol (Progynova®)|All women included will take exogenous hormone with daily administration of Estradiol Valerate (Progynova®), the standard dose used will be 6 mg/day (Cobo et al., n.d.). On day 7 of endometrial preparation patients will be examined with vaginal ultrasound and blood test, to evaluate the endometrial thickness and the hormones levels. In both arms the FET will take place after 6 days of Progesterone supplementation (600 mg per day, vaginal administration of Utrogestan®) According to embryo quality after warming, embryo transfer to the uterine cavity will be performed on day 5 of development under ultrasound guidance whenever possible. Following embryo transfer, luteal support will be continued with vaginally administered P (Utrogestan®). All patients 12 days after the FET will undergo the pregnancy test (blood test to evaluate hCG).
15863927|NCT03930693|Dietary Supplement|Beetroot juice|Beetroot juice shot (70mL containing 400mg inorganic nitrate)
15863928|NCT03930680|Drug|Dexrazoxane|One dose of dexrazoxane
15863929|NCT03930667|Procedure|clips|
15863930|NCT03930667|Procedure|knotting|
15863931|NCT03930654|Behavioral|iPrEP|"iPrEP transforms the standard emergency department (ED) visit experience through an intervention presented as a standard assessment that is equipped to: 1) increase knowledge of HIV transmission and 2) provide information on how to reduce an individual's risk for HIV.
~Women will receive the iPrEP intervention on an iPAD Air tablet device
~iPrEP serves a dual role as a data collection instrument and an intervention--the survey incorporates brief, informational messages into a traditional survey instrument
~iPrEP uses qualitative themes
~iPrEP is divided into sections addressing factors with historical success at predicting pre-exposure prophylaxis (PrEP) adherence
~Scales chosen to measure themes and sections were retained from the original HIV Prevention Trials Network (HPTN) 073 instrument
~Scales were modified (in some cases) for cultural competency and tailoring to women"
15863932|NCT03930654|Behavioral|Usual Care|"Women will receive usual care
~Usual care includes an assessment visit with an emergency department (ED)-assigned social worker who specializes in substance use
~Social worker will offer a list of substance abuse treatment referral agencies"
15863933|NCT03930641|Drug|RTH258|6 mg in prefilled syringe
15863934|NCT03930615|Drug|Letermovir|LET tablet or intravenous infusion at a total daily dose of 240 mg (when given with cyclosporin A) or 480 mg (when given alone).
15863935|NCT03930615|Drug|Placebo|Placebo was administered as tablets matched to LET or as inactive (saline) intravenous infusion.
15863936|NCT03930602|Drug|BMS-986165|Participants will receive BMS-986165.
15863937|NCT03930602|Drug|Fluvoxamine|Participants will receive fluvoxamine.
15863938|NCT03930589|Procedure|Remote Ischemic conditioning|BP cuff inflation for 5 min and deflation for 5 mins with 4 cycles
15863939|NCT03930589|Other|Standard of care|Standard of care
15863940|NCT03930576|Other|Receipt of termination services outside of legal setting|This study uses variation in gestational age to examine the impact of receipt of legal termination services compared to denial and receipt outside legal settings and birth.
15863941|NCT03930563|Dietary Supplement|Pre-beetroot juice supplementation|Before administering beetroot juice to subjects.
15863942|NCT03930563|Dietary Supplement|Post-beetroot juice supplementation|After administering beetroot juice to subjects.
15863943|NCT03930550|Procedure|Tracheal intubation by endoscopy with flexible bronchoscope|A blinking infrared light source is placed on the anterior neck at the level of the cricothyroid membrane to serve as a guide to facilitate finding the way to the trachea
15863944|NCT03930537|Device|Hip replacement|The hip replacement surgery is when a damaged hip is replaced with artificial one
15863945|NCT03930524|Behavioral|Personalized Normative Feedback (PNF)|Personalized normative feedback is generated by a process in which: (1) baseline surveys gather respondent information; (2) a computer program links the data with algorithms to select feedback messages; (3) a format for feedback presentation is specified; and (4) the program generates output. Norms will focus on prevalence of drinking, consuming 4/5+ drinks, total number of drinks consumed each week, and maximum drinks consumed. Normative information will be from the national Monitoring the Future (MTF) study college student sample and the University of Minnesota Twin Cities campus. Students will be sent a link to a website where they see their own personal responses in the feedback. Feedback will detail quantity and frequency of drinking (a) reported by the participant him/herself, (b) according to the participant's perception of the descriptive norm for drinking quantity and frequency for the reference group, and (c) reflecting the actual descriptive norm for the reference group.
15863946|NCT03930524|Behavioral|M-Bridge Online Health Coach|A health coach will correspond with students via a secure online chat platform, utilizing motivational interviewing strategies to encourage students to consider their values and goals, the possibility of behavior change, and available services. The goal of the dialogue is to motivate the student to access alcohol use interventions (Web-BASICS or an in-person health promotion consultation).
15863974|NCT03930277|Diagnostic Test|Electroencephalogram|Electroencephalogram for fetal brain activity monitoring.
15863975|NCT03930264|Drug|Azathioprine 50Mg Tab|tablet
15863976|NCT03930264|Drug|Azathioprine 10mg/mL oral suspension|oral suspension
15863977|NCT03930251|Behavioral|Clinic-Based Cognitive Remediation|Computer-based exercises targeting impairments in cognitive domains (sensory processing, processing speed, attention, working memory, executive functions) are paired with verbal discussions and group-based activities to strengthen metacognition and bridge newly learned cognitive skills to everyday life. Sessions are led twice weekly by a clinician in small groups.
15863947|NCT03930524|Behavioral|Web-BASICS|Web-BASICS is delivered online and responds to individual participant input with the same motivational information and feedback as used in the in-person BASICS intervention. In-person BASICS content (Dimeff et. al., 1999) was developed for online use in studies conducted by Drs. Larimer and Lee (e.g., LaBrie et al., 2013; Lee et al., 2014; Neighbors et al., 2012a). Web-BASICS feedback contains text and graphical feedback regarding students' reported drinking quantity, frequency, peak alcohol consumption, and blood alcohol content (BAC), risks for alcohol problems based on participant family history and consumption patterns, protective behaviors the participant already uses and others he/she might consider, and a tips page with a BAC chart, information on reduced-risk drinking, and where to get more information. Participants can print and/or view their individualized content online for up to 3 months.
15863948|NCT03930524|Behavioral|Health Promotion Consultation|A health promotion consultation via a campus clinic is a confidential exploration of student drug and alcohol use. Health Promotion Consultants help students assess how their alcohol and other substance use affects their life and learn how to make healthier decisions.
15863949|NCT03930524|Behavioral|Self-Monitoring (SM)|Students will be asked to self-report their alcohol use every 2 weeks in response to two main questions (frequency of 4/5+ drinking in the past 2 weeks, frequency of past 2-week 8/10+ drinking), as well as consequences of their drinking. The therapeutic role of SM is two-fold. First, SM facilitates deliberate attention to and reflection on the person's actions, the conditions under which these actions occur, and their consequences (Bandura, 1998; Kanfer, 1970). Hence, SM of drinking behaviors and consequences has the potential to promote awareness of problematic drinking and need for health services. Second, SM affords the opportunity to obtain ongoing information concerning the target behavior, which can be used to inform timely intervention decisions (Nahum-Shani et al., 2016)
15863950|NCT03930511|Procedure|Pulmonary Rehabilitation|According to patients' needs and physician referral, individually tailored treatments of respiratory physiotherapy, functional training, exercise training and patient education
15863951|NCT03930498|Drug|PD-1 blocking antibody|Toripalimab is an antibody targeting PD-1 developed by Shanghai Junshi Biosciences Co., Ltd.
15863952|NCT03930498|Drug|Chemotherapy|Cisplatin and Gemcitabine
15863953|NCT03930498|Radiation|IMRT|IMRT 60-66Gy, 1.8-2.0Gy/f/day
15863954|NCT03930472|Behavioral|Market vouchers|Receiving $80 in vouchers good for fruits and vegetables or for SNAP-eligible foods at 4 out of 5 markets in late July and in August, 2019.
15863955|NCT03930459|Procedure|Static cold storage (SCS)|The liver is flushed and cooled with specialist preservation fluid, then stored in an icebox.
15863956|NCT03930459|Device|Normothermic machine perfusion (NMP)|During NMP, the liver is perfused with oxygenated blood, medications and nutrients at normal body temperature to maintain a physiological milieu.
15863957|NCT03930446|Drug|Ethanol|The 0.8 g/kg body weight dose of oral alcohol (190-proof ethanol) will be divided into 4 servings of 0.2 g/kg each. The 0.8 g/kg dose is equivalent to 4 standard drinks, where a standard drink is defined as one 12 oz beer, one 5 oz glass of wine, or one 1.5 oz shot of 80 proof alcohol. Women will receive a reduced dose (0.68 g/kg) to account for sex differences in total body water
15863958|NCT03930446|Other|Placebo|The placebo beverage will consist of the cranberry or orange juice plus 1% alcohol added as a taste mask. All beverages will be sprayed with an alcoholic mist to provide a strong alcoholic scent.
15863959|NCT03930433|Drug|Nebivolol|Patients are randomly assigned to a ratio of 1: 1: 1, divided into 3 groups.
15863960|NCT03930433|Drug|Diltiazem|Patients are randomly assigned to a ratio of 1: 1: 1, divided into 3 groups.
15863961|NCT03930433|Drug|Nebivolol+Diltiazem|Patients are randomly assigned to a ratio of 1: 1: 1, divided into 3 groups.
15863962|NCT03930420|Behavioral|Connect to Wellness|The research team will train LHD staff and offer them technical assistance to work with small worksites. LHD staff will be trained to deliver the Connect to Wellness program to worksites. Connect to Wellness is a program to disseminate EBIs to small worksites. Worksites receive guidance about EBIs and ongoing implementation assistance from a trained interventionist. In this study, LHD staff will be the interventionists. Worksites participating in Connect to Wellness complete three phases of activities, Assessment, Recommendations, and Implementation. LHD staff will receive Connect to Wellness intervention materials, multiple webinars delivered in real-time, access to a comprehensive intervention and training platform with features that allow them to connect with each other and with research staff, and group technical assistance calls to support their ability to recruit worksites in their communities and deliver Connect to Wellness to these worksites.
15863963|NCT03930407|Procedure|The Hayman uterine compression suture.|Hayman suture is a common technique for uterine compression to stop bleeding due to uterine atony. Hayman described placement of two to four vertical compression sutures from the anterior to posterior uterine wall without hysterectomy. It is usually employed to overcome uterine atony during cesarean section.
15863964|NCT03930394|Diagnostic Test|Contrast ultrasound perfusion imaging|Contrast ultrasound perfusion imaging for microvascular perfusion, and carotid ultrasound data on intima-media thickness (or plaque size) will be serially assessed in subjects started on ponatinib.
15863965|NCT03930381|Other|ASTHMAXcel App|ASTHMAXcel includes interactive games, educational videos, quizzes and personalized feedback to teach different aspects of asthma management.
15863966|NCT03930368|Other|low GI diet with regular supplementation of raw corn starch|Patients will be guided with a low GI diet with 60%~70% of energy from carbohydrates. RCS constituted 30%~50% of daily carbohydrate, and was supplemented as snacks every 4~6 hours (25g per time) especially at night.
15863967|NCT03930355|Other|Blood transfusion|Patients who received blood transfusion in the perioperative period
15863968|NCT03930355|Other|Control|Patients who did not receive blood transfusion in the perioperative period
15863969|NCT03930342|Behavioral|Native-CHOICES|Native CHOICES is a behavioral intervention for prevention of prenatal alcohol exposure in women at high risk for alcohol-exposed pregnancies. The intervention uses motivational interviewing and cognitive-behavioral strategies, and targets adoption of effective contraception and reduction of alcohol use.
15863970|NCT03930329|Behavioral|MBRP group|same as arm description
15863971|NCT03930316|Device|NOX T3|portable sleep study device
15863972|NCT03930303|Behavioral|Multimedia- based patient education|Patients will receive a 5 minutes video education before D&C
15863973|NCT03930290|Diagnostic Test|Vaginal tactile imager|Vaginal elasticity evaluation by vaginal tactile imaging analysis.
15863978|NCT03930251|Behavioral|Partial-Remote Cognitive Remediation|Computer-based exercises targeting impairments in cognitive domains (sensory processing, processing speed, attention, working memory, executive functions) are paired with verbal discussions and group-based activities to strengthen metacognition and bridge newly learned cognitive skills to everyday life. Sessions are led once weekly by a clinician in small groups and clients gain additional practice by accessing clinician-assigned computer-based exercises independently.
15863979|NCT03930238|Behavioral|VA MapTrek|The objective is to report activity levels in our virtual environment to Veterans, thereby encouraging them to walk more.
15863980|NCT03930238|Behavioral|Fitbit Only|Fitbit Only
15863981|NCT03930225|Behavioral|Stigma Directed Psycho-educational Intervention program|psycho-educational intervention with emphasis on Stigma
15863982|NCT03930212|Drug|Progesterone|received rectal progesterone suppositories 400 mg once daily
15863983|NCT03930212|Drug|Placebos|received placebo suppositories rectally once daily.
15863984|NCT03930199|Other|Needs-based intervention (physical, psychological, or both)|Individuals identified as having physical issues (poor prosthesis fit, function, comfort or physical conditioning) will receive prosthetic care and physical therapy. This includes adjusting socket fit, component fit and repair, and in some instances replacement. Rehabilitation strategies include gait and prosthesis use retraining, balance fall-prevention, and range-of-motion training, strengthening, pain management, and activities of daily living training, based on participant-reported mobility goals. Individuals whose prosthesis use is reduced due to psychological issues will be provided with motivational interviewing and other related psychological interventions. During these interventions participant will be asked to set personal goals using a semi-structured interview that explores facilitators and barriers to wearing their prosthesis. If both physical and psychological issues are present, participant may receive both types of interventions simultaneously.
15863985|NCT03930186|Drug|Apremilast|Apremilast
15863986|NCT03930173|Drug|18F-fluciclovine|A single dose of 18F-fluciclovine will be administered intravenously for PET/CT imaging. The standard 10 mCi dose will be used for this study.
15863987|NCT03930173|Device|PET/CT of the brain|Each subject will undergo 18F-fluciclovine PET/CT of the brain which will be performed ≤ 30 days from equivocal MRI brain
15863988|NCT03930160|Other|Logistic Organ Dysfunction System Score|Variables of logistic organ dysfunction system score, including: GCS; heart rate; systolic BP; blood urea; serum creatinine; urine output; leucocyte count; platelet count; PaO2/FiO2; serum bilirubin; prothrombin time.
15863989|NCT03930147|Procedure|ASV ventilation|Ventilation on ASV mode
15863990|NCT03930134|Procedure|sparse uterine suture|The slowly absorbed Vicryl 1 suture with a large round needle is introduced intramyometrially right above the endometrium. The suture starts in one corner and proceeds along the lower then the upper edge returning back to the incision point. Subserous layer is closed upon using the same thread in order to cover the purse suture and to complete the haemostasis while increasing the wound thickness.
15863991|NCT03930134|Procedure|one layer uterine closure|one layer classical continious uterine closure using slowly absorbed Vicryl 1
15863992|NCT03930121|Other|Anodal transcranial direct current stimulation (tDCS) combined with speech-language therapy (SLT, including naming therapy and communicative-pragmatic therapy)|Two daily sessions of intensive SLT combined with tDCS of the left primary motor cortex (M1)
15863993|NCT03930108|Other|SOFA score|Variables of sequential organ failure assessment score, including: P:F ratio; MAP or vasoactive treatment; creatinine or 24-h diuresis; platelet count; serum bilirubin; GCS.
15863994|NCT03930095|Behavioral|Acceptance-based Behavior Therapy|The protocol is widely based on Roemer and Orsillo (2007) acceptance model of GAD, using functional assessment, psychoeducation, mindfulness, commitment to valued behavior, and exposure techniques used in a willingness improvement verbal context.
15863995|NCT03930095|Behavioral|Non-directive Supportive Therapy|NDST consists in a form of therapeutic intervention from which all intervention principles pertaining to specific psychotherapeutic protocols are removed while maintaining the so-called common factors from different psychotherapy approaches. In other words, it is an unstructured therapy without specific psychological techniques other than those belonging to the basic interpersonal skills of the therapist, such as reflection, empathic listening, encouragement, and helping people to explore and express their experiences and emotions.
15863996|NCT03930082|Other|Frailty Index Scale|We will evaluate the frailty with a Frailty Index Scale in elderly patients undergoing gastrointestinal surgery.
15863997|NCT03930069|Drug|Misoprostol|prostaglandin E1 analogue vaginally inserted two hours before hystertsopic myomectomy to evaluate intraoperative blood loss and operative time needed for completion of myomectomy
15863998|NCT03930069|Drug|Vasopressin|one ampoule of vasopressin was diluted to 50 ml of normal saline, and 10 ml (4 units of vasopressin) was withdrawn in a syringe. Needle was inserted through the working channel of the hysteroscope until its tip was seen. The needle tip was pointed to the site of injection under hysteroscopic guidance during the whole injection technique. Aspiration was done first to avoid intravascular injection of vasopressin. The diluted solution was injected into the surface, especially to parts with dilated vasculature till they blanch.
15863999|NCT03930056|Device|C-Brace II|"Participant will complete 3-6 orthoses sessions to complete clinical evaluations and fittings conducted by certified orthotists.
~Participant will receive 10-20, one hour training sessions over 1-2 months in the lab. These sessions include tuning the device and system tweaks in accordance to needs/preferences of participant, vitals signs, skin checks, pain, and exertion levels. Sessions involve training with the device, which includes putting on / taking off the device, transfer training, gait training, and balance and fall prevention.
~Up to 20 sessions will be conducted until minimum safety guidelines are reached during a minimum of at least 3 training sessions in a row.
~Participant will take the assigned device home to use for a 3-month period. Participant will be given an activity monitor to wear at all times except showering and instructed how to charge the device and use it. Participant will return for testing at 3, 6 and 12 months after receiving the brace for testing."
15864029|NCT03929744|Drug|Atorvastatin|Administered orally.
15864030|NCT03929744|Drug|Simvastatin|Administered orally.
15864031|NCT03929744|Drug|Midazolam|Administered orally.
15864032|NCT03929731|Diagnostic Test|Indocyanine Green Angiography|Intravenous injection of dye-indocyanine green
15864033|NCT03929718|Drug|Spironolactone|receive spironolactone treatment after CTI ablation
15864034|NCT03929718|Drug|No Spironolactone|no spironolactone treatment
15864000|NCT03930056|Device|Traditional Care KAFO intervention|Participant will continue with use of their own KAFO. Participant will receive 10-20, one hour training sessions over 1-2 months in the lab, if Patient is not already receiving care in a therapy setting. These sessions include tuning the device and system tweaks in accordance to needs/preferences of participant, vitals signs, skin checks, pain, and exertion levels. Sessions involve training with the device, which includes putting on / taking off the device, transfer training, gait training, and balance and fall prevention. Up to 20 sessions will be conducted until minimum safety guidelines are reached during a minimum of at least 3 training sessions in a row. Participant will continue with the assigned device home to use for a 3-month period. Participant will be given an activity monitor to wear at all times except showering and instructed how to charge the device and use it. Participant will return for testing at 3, 6 and 12 months after receiving the brace for testing.
15864001|NCT03930043|Diagnostic Test|Metagenomic shotgun sequencing|preforming metagenomic shotgun sequencing on patients' or volunteers' feces specimen
15864002|NCT03930017|Biological|Seasonal influenza vaccine - VAXIGRIP TETRA influenza vaccine (quadrivalent, split virion, inactivated)|Influenza virus (quadrivalent, split virion, inactivated) of the strains that comply with the World Health Organization (WHO) recommendations (Northern Hemisphere) and European Union (EU) decision for the 2018/2019 season. The quadrivalent vaccine is propagated in fertilised hens' eggs from healthy chicken flocks.
15864003|NCT03929991|Other|Observational|To record social and clinical characteristics
15864004|NCT03929965|Drug|Anlotinib|Anlotinib
15864005|NCT03929952|Other|Neurofeedback treatment|"20 sessions of neurofeedback of 5 minutes each consisting of :
~The patient is equipped with an electroencephalography headset. The feedback visual has the form of a candle flame and is modulated by alpha synchrony.
~The height of the flame is proportional to the intensity of the patient's pain. The patient has to concentrate on the height of this flame by thought to modulate it and, at the same time, to decrease the intensity of his own pain."
15864006|NCT03929952|Other|functional magnetic resonance imaging (fMRI) scans|The patient in alpha synchrony related state and in rating state will undergo an fMRI
15864007|NCT03929939|Behavioral|Exercise training and healthy eating|"Exercise Training: A personalized training program will be developed for participants. Based on maximal steady state heart rate and resting heart rate, three training zones (recovery, base pace, and maximal steady state) will be determined. The target heart rate for each training zone will be set for each patient. The majority of training sessions during the early phase of the program will be prescribed as base pace with target heart rate equivalent to about 75% of maximal. Initially, patients will train 3 times per week for 20-30 minutes per session by walking, jogging or swimming. As the patients become relatively fit, the duration of the base training sessions will be prolonged, and subsequently sessions of increased intensity (i.e., maximal steady state) will be added.
~Healthy Eating: Participants will be provided with dietary advice consistent with the American Heart Association guidelines (D.A.S.H. diet eating plan)."
15864008|NCT03929926|Other|Best Practice|receive usual care
15864009|NCT03929926|Behavioral|Cancer Educational Materials|Receive educational materials via mail
15864010|NCT03929926|Other|Behavioral, Psychological or Informational Intervention|Receive shared decision making and lung cancer screening information
15864011|NCT03929926|Other|Counseling|Undergo decision counseling session
15864012|NCT03929913|Device|Transmural Systems Transcatheter Mitral Cerclage Annuloplasty (TMCA)|The Transcatheter Mitral Cerclage Annuloplasty implant comprises two components, with or without a coronary artery protection element, and the wishbone lock with coronary sinus and RVOT limbs. The procedure is performed from a transjugular venous approach. Coronary guidewires and microcatheters are used to navigate into a coronary vein towards the target capture catheter. The implant is then attached to the back end of the guidewire and pulled out of the internal jugular sheath. The position of the implant is adjusted so that the coronary protection element lies directly over any underlying branch of the left coronary artery. The wishbone lock is then advanced over the two limbs of the implant and the desired tension is titrated to the degree of mitral regurgitation. Coronary angiography is performed to confirm there is no coronary compression. Once the desired tension has been achieved, the wishbone lock is locked and the two limbs of the implant are cut with a cutter catheter.
15864013|NCT03929887|Other|Kidney Biopsy|Patients scheduled to undergo a clinically indicated kidney biopsy will be requested to consent to an additional renal core and various patient-derived samples.
15864014|NCT03929861|Drug|Fluconazole (BAYT006267) 150 mg capsules|Fluconazole 150 mg
15864015|NCT03929861|Drug|Fluconazole 150 mg capsules (DiflucanTM)|Fluconazole 150 mg
15864016|NCT03929848|Procedure|Cuff pressure|observe and record the required cuff pressure to prevent gas leakage during mechanical ventilation for laryngomicrosurgery
15864017|NCT03929835|Drug|Cannabis oil|T1/C20 CBD
15864018|NCT03929835|Drug|Placebo|Olive oil with chlorophyl
15864019|NCT03929822|Diagnostic Test|Contrast-Enhanced Spectral Mammography|A standard dose of contrast material for other contrast mammography examinations and for body CT scanning, 1.5 ml/kg of Iohexol350 will be injected intravenously (IV) using a power injection (3-4 ml/s) with a maximum does of 150 ml. The IV injection is performed while the patient is in a sitting position. The mammogram will be performed in a standing position.
15864020|NCT03929809|Device|Cochlear Implant|adults with unilateral hearing loss who wish to regain bilateral hearing will be implanted with a cochlear implant on their deafened ear.
15864021|NCT03929783|Procedure|Contrast Enhanced Digital Mammography|Undergo CEM
15864022|NCT03929770|Procedure|with pause|When the practitioner or expert investigator recognize that the tip of Swan-Ganz catheter arrive in the right ventricle, the practitioner pause the advancement for 10 sec. Next, the practitioner re-advance it to the pulmonary artery.
15864023|NCT03929770|Procedure|without pause|When the practitioner or expert investigator recognize that the tip of Swan-Ganz catheter arrive in the right ventricle, the practitioner advance it continuously without pause to the pulmonary artery.
15864024|NCT03929757|Biological|Ad26.ZEBOV|Participants will receive 0.5 mL IM injection of Ad26.ZEBOV as first vaccination.
15864025|NCT03929757|Biological|MVA-BN-Filo|Participants will receive 0.5 mL IM injection of MVA-BN-Filo as second vaccination.
15864026|NCT03929757|Biological|MenACWY|Participants will receive 0.5 mL IM injection of MenACWY.
15864027|NCT03929744|Drug|LY3502970|Administered orally.
15864028|NCT03929744|Drug|Placebo|Administered orally.
15864037|NCT03929679|Drug|semaglutide|Patients will be treated with commercially available semaglutide in a prefilled pen injector (FlexTouch® variant) according to routine local clinical practice at the discretion of the treating physician. Other anti-hyperglycaemic treatments will be prescribed at the physician's discretion.
15864038|NCT03929666|Drug|ZW25 (Zanidatamab)|"Part 1: administered IV at dose levels and schedules determined by the Safety Monitoring Committee (SMC)
~Part 2: RD identified in Part 1"
15864039|NCT03929666|Drug|Capecitabine|Administered orally twice daily (PO bid)
15864040|NCT03929666|Drug|Cisplatin|Administered IV
15864041|NCT03929666|Drug|Fluorouracil|Administered IV
15864042|NCT03929666|Drug|Leucovorin|Administered IV
15864043|NCT03929666|Drug|Oxaliplatin|Administered IV
15864044|NCT03929666|Drug|Bevacizumab|Administered IV
15864045|NCT03929666|Drug|Gemcitabine|Administered IV
15864046|NCT03929653|Other|Personalized therapy model with Molecular Tumor Board and Next Generation Sequencing|This study is to observe this therapy model outcomes
15864047|NCT03929640|Drug|Acetaminophen|Acetaminophen 650 mg tablet every 6 hours
15864048|NCT03929640|Drug|Placebo|Placebo oral tablet every 6 hours
15864049|NCT03929640|Drug|Ibuprofen|Ibuprofen 600 mg tablet every 6 hours
15864050|NCT03929627|Other|Cortisol awakening response|Cortisol awakening response
15864051|NCT03929614|Other|MOBI validation|Final version will be distributed to 176 French speaking subjects, 30 of whom are randomly selected and will fill it a second time, at after 72 hrs. To consider of its kind, Moreover, the Bem Inventory for Children will be completed by everyone as well as the SF-12 and SRS-22.
15864052|NCT03929601|Drug|Rituximab|Participants will receive Rituximab dosing from Week 1 to Week 4 of the trial. Rituximab will be given by IV infusion over a 3-8 hour period, at a dose of 375mg/m2 on four visits each one week apart.
15864053|NCT03929601|Drug|Abatacept|Participants will receive initial Abatacept dosing at Week 16 of trial. Abatacept will be given by a subcutaneous (SC) formulation weekly for two years, and dosing be will determined according to weight: Up to 25 kg: 50 mg (0.4 mL); 25 to <50 kg receive 87.5 mg (0.7 mL), and > 50 kg receive 125 mg (1.0 mL). Abatacept treatment will continue for full 24-month period regardless of whether participants have progressed to stage 3 type 1 diabetes during treatment.
15864054|NCT03929588|Device|Hand-held device supported by a mobile application|Hand-held device supported by a mobile application to obtain refractive error of the eye.
15864055|NCT03929588|Device|Phoropter|Manual refraction and ETDRS chart
15864056|NCT03929588|Device|Autorefractor|Automated refraction
15864057|NCT03929575|Dietary Supplement|Placebo of calcium|Ingestion of 250 mg of calcium
15864058|NCT03929575|Dietary Supplement|Rhodiola|Ingestion of 250 mg of Rhodiola
15864059|NCT03929575|Dietary Supplement|Rhodiola and Cordyceps|Ingestion of 250 mg of Rhodiola and 225 mg of Cordyceps
15864060|NCT03929562|Behavioral|Brief advice|One 10-minute brief advice session
15864061|NCT03929562|Behavioral|Health coaching|Two 50-minute health coaching sessions will use a non-confrontation motivational interviewing (MI) style. Intervention delivery will include expressing concern about unhealthy drinking, providing feedback linking alcohol use and health (related to surgery and general health), advising the patient regarding abstinence or alcohol use reduction, and working with the patient to set a drinking goal if he/she is ready to change. We will also include a personalized feedback component to address the links between pre-operative alcohol use and postoperative morbidity/mortality.
15864062|NCT03929549|Device|RCMP titration|An overnight titration polysomnogram with gradual mandibular protrusion and assessment of polysomnographic parameters (i.e. AHI, oxygen saturation, etc.) at various magnitudes of protrusion.
15864063|NCT03929523|Device|End-ischemic Hypothermic Oxygenated Machine Perfusion (HOPE)|"In the experimental group, ECD liver grafts will first undergo a classical static cold (4°C) storage with Institute George Lopez (IGL-1)® solution from graft harvesting until transport to the transplantation center. They will then undergo a hypothermic oxygenated perfusion (HOPE) via the portal vein for a period of 1 to 4 hours (minimum 1 hour) after the back-table phase (graft preparation), in parallel with the recipient hepatectomy, using the CE-certified Liver Assist® perfusion pump/device (Organ Assist®, the Netherlands) with Machine Perfusion Solution (Belzer-MPS, CE-certified)."
15864064|NCT03929523|Device|classic static cold storage|The control group will consist of a classic static cold (4°C) storage with Institute George Lopez (IGL-1)® solution from graft harvesting until liver transplantation, which is the gold standard procedure in liver transplantation
15864065|NCT03929510|Drug|14C-PF-06651600|Oral solution of 200 mg 14C labeled PF-06651600 containing approximately 300 nCi radioactivity
15864066|NCT03929510|Drug|14C-PF-06651600 IV|IV solution 60 micrograms of 14C labeled PF-06651600 containing approximately 300 nCi radioactivity
15864067|NCT03929510|Drug|PF-06651600|Oral solution 200mg
15864068|NCT03929497|Drug|Lu AF11167|Lu AF11167 - 2 or 4 mg/day; tablets, orally
15864069|NCT03929484|Device|Nasal reservoir cannula|The experimental oxygen mask (nasal reservoir cannula) fits over a standard nasal cannula. The system is designed to reduce administered oxygen to deliver an equal or higher fraction of inspired oxygen (FiO2) per oxygen delivered (L/min) compared with a standard nasal cannula alone.
15864070|NCT03929471|Other|Target weight correction protocol|The intervention group will undergo target weight correction process based on time averaged fluid overload measurement (by bio-impedance).
15864071|NCT03929445|Device|Endotracheal tube introducers|"Endotracheal tube introducers (gum elastic bougie) for emergency intubation The endotracheal tube introducer (ETI) is an effective and inexpensive adjunct to difficult airway management that is easy to use.
~ETI is solid introducer 60-70 cm long with a 35 - 40 distally angulated (Coude) tip. They are easy to use, widely available, and have been used as adjuncts to difficult direct laryngoscopy for many decades.
~The gum elastic bougie is usually guided by tactile clicks as the device passes the cartilage rings of the trachea. After Supraglottic devices are removed, an ETT can subsequently be railroaded over the bougie."
15864101|NCT03929185|Diagnostic Test|blood analysis with SCENT B1|analyze blood samples with chemoresistive sensors
15864102|NCT03929185|Diagnostic Test|tissue analysis with SCENT B1|analyze tumor biopsies collected during surgery with chemoresistive sensors
15864103|NCT03929172|Biological|AAVLP-HPV|20μg/injection formulated in a ready to use solution containing 100mM sodium citrate, 2.5 mM MgCl2, 0.001% pluronic F-68, pH 6.0 for i.m. injection as 0.5 mL per injection.
15864072|NCT03929432|Device|Active Transcranial Direct Current Stimulation with SLT|"Soterix Medical 1×1 transcranial Direct Current Stimulator for Clinical Trials (1x1 tDCS-CT).
~Excitatory stimulation to the left hemisphere will be achieved through a 1x1 montage utilizing two carbon-rubber electrodes and 5x7 EASY pad sponges (A-tDCS [excitatory]left target; C-tDCS [inhibitory]right hemisphere). Each PWA will have a unique 5-digit tDCS program code for each treatment phase. One code will instruct the 1x1 tDCS-CT to administer active stimulation as describe above (i.e., 1.5 mA for 20 min). The other will administer 1.5 mA for only a few seconds to simulate active stimulation. SLT will consist of Semantic Feature Analysis, Phonological Component Analysis, and Verb Network Strengthening Treatment"
15864073|NCT03929432|Device|Sham Transcranial Direct Current Stimulation with SLT|Control condition in which only SLT is administered.Participant receives 1.5 mA for only a few seconds to simulate active stimulation, then the stimulation will cease. SLT will consist of Semantic Feature Analysis, Phonological Component Analysis, and Verb Network Strengthening Treatment
15864074|NCT03929419|Drug|intranasal insulin|application of 160 units human insulin
15864075|NCT03929419|Drug|Placebo spray|nasal spray containing placebo solution
15864076|NCT03929406|Device|Brain Tissue Imprint|"Brain Tissue Imprint procedure (BTI) is performed during DBS surgery. Before the implantation of the electrode, the surgeon uses a dilator. It is a rigid stylet with a blunt end, intended to prepare the way for the final electrode. This dilator is lowered gently through the cerebral parenchyma up to the target then removed to be replaced by the electrode.
~In our BTI study, the standard dilator used in DBS surgery will be replaced by a CE marked Medical Device. This brain imprint kit will be used for each hemisphere. The procedure is the following:
~The guide tube with the first stylet is set up to the target
~Withdrawal of the first stylet and insertion of the second stylet for one minute to have a spontaneous and adequate tissue adhesion
~Withdrawal of the guide tube containing the stylet. This last step will prevent contamination of the harvested material on the stylet during the removal."
15864077|NCT03929393|Behavioral|Mindful Movement|The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception, by providing opportunities for education, practice, and social suppo
15864078|NCT03929393|Other|Keys to Health & Wellbeing|This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
15864079|NCT03929380|Other|Squat protocol|60% of 1RM weight for 100 squat reps
15864080|NCT03929367|Drug|Oxytocin|Single IV administration of oxytocin
15864081|NCT03929354|Behavioral|Risk Factors Modification Programme|12-week supervised risk factor modification programme derived from the EuroAction Study standards.
15864082|NCT03929354|Behavioral|Standard Care|Patients advised to adjust lifestyle without the support of the structured supervised programme.
15864083|NCT03929341|Diagnostic Test|Coronary Computed Tomography Angiography (CCTA)|Cardiac imaging test that is able to detect changes is cardiac vessels and the heart.
15864084|NCT03929341|Other|Cardiac Link|Clinical patient flow pathway that will enable radiologist to activate expedited cardiology referral for patients who exhibit clinically significant changes during CCTA.
15864085|NCT03929328|Procedure|High flow oxygen therapy in spontaneous breathing trial|Patients were randomized to undergo a spontaneous breathing trial with high flow oxygen therapy that is connected on endotracheal tube. Patients tolerating the spontaneous breathing trial underwent extubation.
15864086|NCT03929315|Behavioral|OLV technique on tracheo-bronchial model|Models will range in size from 6 yrs to 6 weeks.
15864087|NCT03929302|Device|MyTAP oral appliance plus mouth shield|The midline traction oral appliance (MyTAP, AMI Inc., Dallas, Texas) is currently marketed as a medical device to treat snoring and obstructive sleep apnea and is FDA cleared will be used only in Phase-2 of the study. Phase-1 doesn't include any intervention.
15864088|NCT03929289|Behavioral|Social Facilitation|During the functional Magnetic Resonance Imaging (fMRI) scans, the subject will perform cognitive tasks measuring eye movements and attention alternatively observed by a familiar peer (in an adjacent room) or not.
15864089|NCT03929276|Device|high-intensity laser therapy & exercises|A total of 15 sessions of high-dose laser treatment- i Lux Laser (Mectronic Medicale, Italy)- (in the first phase, 8 Watt for the analgesic effect; in the second phase, 12 Watt in burst mode for the biostimulation effect; and finally in the third phase with 8 Watt) will be applied.
15864090|NCT03929276|Device|Shame laser & exercises|Sham laser treatment (the same device to be used, 0 watts) will be given.
15864091|NCT03929276|Other|exercise|Therapeutic exercises All participants received 25-minutes of passive stretching, active assisted range of motion and codman pendicular exercises (10 repetitions, 3 sets, 3-minutes rest between sets) to the shoulder joint, supervised by the same physiotherapist five times a week for 3 weeks.
15864092|NCT03929263|Behavioral|Real-time fMRI neurofeedback|Participants will attempt to regulate own and/or their partner's brain activation in a specified brain region via real-time fMRI neurofeedback.
15864093|NCT03929250|Drug|2g Centella asiatica water extract product|2g Centella asiatica water extract product is a powder containing Centella asiatica water extract and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.
15864094|NCT03929250|Drug|4g Centella asiatica water extract product|4g Centella asiatica water extract product is a powder containing Centella asiatica water extract and excipients to improve palatability, color matching and dispersability in water. It will be consumed on an empty stomach orally suspended in 10-12 ounces of water.
15864095|NCT03929237|Other|observe when return to school after surgery|Short written questionnaire asking when they returned to school and what accommodations, if any, the school made available for them
15864096|NCT03929224|Drug|Medicinal honey and bacitracin|Treat healing surgical site with medicinal honey and bacitracin
15864097|NCT03929224|Drug|Bacitracin|Treat healing surgical site with bacitracin
15864098|NCT03929211|Drug|CPI-613|Given intravenously, CPI-613 dose will be 2,000 mg/m² and will not escalate.
15864099|NCT03929211|Drug|Hydroxychloroquine|Given by mouth, hydroxychloroquine will be dose escalated from 600 mg to 1,200 mg orally given 2 hours before the CPI-613 infusion on days 1-5 of every 28 day cycle in a 3+3 dose escalation design.
15864100|NCT03929198|Other|Healthy Lifestyle|6 week Diet, Exercise training, Behavioral modification
15864104|NCT03929172|Drug|Placebo|0.5 mL 100 mM Sodium Citrate, 2.5 mM MgCl2, 0.001% Pluronic F-68, pH 6 for i.m. injection as 0.5 mL per injection.
15864105|NCT03929159|Procedure|Biospecimen Collection|Undergo blood biospecimen collection
15864106|NCT03929146|Drug|Exparel|Patients will receive a local injection of liposomal bupivacaine near the end of their shoulder arthroplasty operation.
15864107|NCT03929146|Procedure|Interscalene Nerve Block|Patients will undergo a pre-operative interscalene nerve block performed by the anesthesiology team.
15864108|NCT03929133|Device|automatic screening machine on congenital heart disease|
15864109|NCT03929120|Biological|Allogeneic Bone Marrow Derived Mesenchymal Stem Cells (BMD-MSCs)|Subjects will be treated with regular standard of care plus 0.5-1 million MSC/Kg intravenously.
15864110|NCT03929107|Biological|Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T cells|patient's T cells were seperated and engineered into Interleukin-7 and Chemokine (C-C Motif) Ligand 19-expressing CD19-CAR-T cells, and retransfused into the patient for treatment of their B cell lymphoma.
15864111|NCT03929094|Drug|Paclitaxel for Injection（Albumin Bound）|Patients firstly receive nab-paclitaxel 100 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity，death or begin a novel therapeutic.
15864112|NCT03929094|Drug|Gemcitabine|Patients secondly receive gemcitabine 1000 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks until the disease recurrence or unacceptable toxicity，death or begin a novel therapeutic.
15864113|NCT03929081|Behavioral|Inference Based Approach (IBA)|The Inference Based Approach aims at strengthening reality testing in patients with Obsessive-Compulsive Disorder, by teaching the patient to actively rely on sensory information.
15864114|NCT03929081|Behavioral|Cognitive Behavioural Therapy (CBT)|CBT teaches the patient with Obsessive-Compulsive Disorder to refrain from compulsive acts.
15864115|NCT03929068|Drug|carbidopa-levodopa|Motivated by the success of dopaminergic drugs in treating rigidity associated with Parkinson's disease, some neurologists have used carbidopa-levodopa to attempt to improve spasticity in ALS and PLS patients.
15864116|NCT03929068|Drug|Placebo Oral Tablet|Placebo will be given to maintain blinding of participants and study team.
15864117|NCT03929055|Device|Physiological assesment|"Arterial blood gas analysis.
~esophageal pressure variation during inspiration and expiration
~Arterial blood pressure, central venous pressure (CVP), heart rate.
~diaphragmatic contraction detected by ultrasound"
15864118|NCT03929042|Device|Posture correction girdle|Our research team has designed a prototype of posture correction girdle based on the clinical, textile science, material and ergonomics engineering analyses as an alternative to hard brace for AIS. The design of the posture correction girdle incorporates different mechanisms, such as 1) compression and pulling forces through a close fit of the intimate apparel, 2) lumbar flexion by using supporting belt, 3) transverse forces applied by inserting pads inside the pocket lining by using the principle of the 3-point pressure system.
15864119|NCT03929029|Drug|Nivolumab|Nivolumab is an antibody that prevent cancer cells from suppressing the immune response so that the body can attack and kill the cancer
15864120|NCT03929029|Biological|NeoVax plus Montanide|Montanide® is an activator of immunity that enhances response to vaccination through slow release of the peptides from the injection site and its ability to create an inflammation and stimulate the recruitment of specific cells of your immune system. Montanide® will be mixed with the personalized neoantigen vaccine
15864121|NCT03929029|Drug|Ipilimumab|Ipilimumab is an antibody that prevent cancer cells from suppressing the immune response so that the body can attack and kill the cancer
15864122|NCT03929016|Drug|DNDI-0690|capsules of 10, 100 and 200 mg
15864123|NCT03929016|Drug|Placebo of DNDI-0690|capsules of matching placebo
15864124|NCT03929003|Behavioral|Inspired|The investigators will be studying the ability of using videogame-based rewards to increase smoking abstinence when they are made contingent on meeting abstinence goals.
15864125|NCT03928990|Device|ActiGraph accelerometer|ActiGraph accelerometer + calibration with Cortex MetaMax3B ergospirometer
15864126|NCT03928977|Diagnostic Test|Functional Magnetic Resonance Imaging|fMRI sequences done with motor paradigm (right and left arm), followed by resting state acquisition
15864127|NCT03928951|Other|General practitioner reassessment of urinary infection antibiotherapy prescribed by emergency departments|Antibiotherapy will be prescribed by emergency physicians and general practitioners will be contacted 4 to 5 days later to know if antibiotherapy was modified
15864128|NCT03928938|Device|Electronic patient reported outcomes|Electronic patient reported outcomes-tool
15864129|NCT03928925|Other|Bougie|disposable tracheal tube introducer of approximately 70 cm in length
15864130|NCT03928925|Other|Endotracheal Tube with Stylet|endotracheal tube preloaded with a removable, malleable stylet
15864131|NCT03928899|Procedure|New procedure|An optimal management on the timing and mode of delivery of pregnant women with GDM, by a comprehensive assessment and consideration of their fetal weight, gestational age, and cervical ripeness.
15864132|NCT03928886|Device|bilateral two-view (CC and MLO) FFDM (full field digital mammography) using patient-assisted compression mode|Patient-assisted mode of Senographe Pristina (a commercial mammography medical device consisting of the Senographe Pristina FFDM system -2D- and Senographe Pristina DBT option -3D-) for FFDM imaging procedure. The patient-assisted compression feature enables the patient to personally refine breast compression using a hand-held remote control after the compression has been initiated by the operator, which is required to ensure proper breast positioning.
15864133|NCT03928886|Device|bilateral two-view (CC and MLO) FFDM (full field digital mammography) using standard compression mode|"Standard compression mode of Senographe Pristina (a commercial mammography medical device consisting of the Senographe Pristina FFDM system -2D- and Senographe Pristina DBT option -3D-) for FFDM imaging procedure.
~Study-related compressions will consist of the first and second CC and MLO compressions performed on each breast during each subject's exam."
15864134|NCT03928873|Device|Low energy ESWT|1500 impulses and 0.006mJ/mm2, 3bar, once per week for 4 weeks
15864135|NCT03928873|Device|High energy ESWT|1500 impulses and 0.01mJ/mm2, 5.8bar, once per week for 4 weeks
15864136|NCT03928873|Device|Sham ESWT|sham treatment using ESWT Probe with only vibration without transferring energy once per week for 4 weeks
15866278|NCT03911648|Drug|0.5 ml.kg-1 bupivacaine 0.25% with the addition of 3 mg/kg lidocaine 1%|Caudally
15864137|NCT03928860|Other|OMT session|Patients with PAD will be received 30 minutes of osteopathic manual treatment for one session. During application, the patient was in the supine position. OMT treatment session include, sub occipital release technique, supraclavicular release technique, sternal mobilization, omentum minus release, liver pumping, diaphragmatic mobilization, grand manevra technique, hip mobilization, knee mobilization and ankle mobilization. Each technique was applied for 3 minutes to patients.
15864138|NCT03928847|Drug|Epigallocatechin-3-gallate (EGCG)|Epigallocatechin-3-gallate (EGCG) capsules
15864139|NCT03928834|Behavioral|Adapted Nzira Itsva|Adolescents will be provided an enhanced adherence package consisting of VL testing using DBS, including the NI intervention and low-cost genotyping and drug resistance monitoring. Participants receiving the intervention will have their first session after recruitment and enrollment, and will schedule up to 4 additional booster sessions at a time convenient for them spaced approximately 1 month apart. This may be modified after the formative assessment.
15864140|NCT03928821|Biological|PGT121|20 mg/kg administered intravenously
15864141|NCT03928821|Biological|PGDM1400|20 mg/kg administered intravenously
15864142|NCT03928821|Biological|10-1074|20 mg/kg administered intravenously
15864143|NCT03928821|Biological|VRC07-523LS|20 mg/kg administered intravenously
15864144|NCT03928808|Biological|Fecal Microbiota Transplantation (FMT)|Nasogastric administration of OpenBiome 25 g/mL solution administered nasogastrically once weekly for 4 consecutive weeks
15864145|NCT03928795|Procedure|elective caesarean section|elective caesarean section
15864146|NCT03928782|Radiation|5 Gy or 10 Gy units of whole-body radiation|8 subjects will be received 5 Gy units of whole-body radiation or 10 Gy units of whole-body radiation.
15864147|NCT03928756|Behavioral|Push Notifications with Tailored Intervention Content|Participants will receive a push notification with a therapeutic message (e.g., about stress, mood, substance use motives, tools to reduce risky substance use) tailored to their recent daily or weekly survey responses. Messages include visual (memes, images, videos) and written content.
15864148|NCT03928756|Behavioral|Push Notifications with Engaging, Non-therapeutic Content|Participants will receive a push notification with an engaging, non-therapeutic message (e.g., fun facts).
15864149|NCT03928756|Behavioral|No Push Notifications|Participants will not receive a push notification.
15864150|NCT03928743|Drug|Bimekizumab|Subjects will receive bimekizumab at pre-specified time-points.
15864151|NCT03928743|Other|Placebo|Subjects will receive placebo at pre-specified time-points during the Double-Blind Treatment Period.
15864152|NCT03928730|Procedure|resection and removal|Surgical resection or removal for histopathological examination
15864153|NCT03928717|Behavioral|Text-Based Adherence Game|A mobile health intervention facilitated by a cloud-hosted web application and designed to promote adherence to HIV care through text message-delivered gamification strategies including peer comparison, point reinforcement, feedback on adherence outcomes, facilitation of social support, and use of an engaging and culturally-relevant story-line.
15864154|NCT03928717|Behavioral|Standard of Care (SOC)|A 10- to 20-minute in-person intervention led by a trained HIV treatment adherence counselor focused on providing basic knowledge of HIV and HIV treatment, motivating participants to engage in HIV treatment, and problem-solving barriers to adherence.
15864157|NCT03928691|Drug|Magnesium Sulfate|4 gram MgSo4 diluted in 150 cc saline infused IV within 30 minutes as loading dose then the patient will receive the maintenance dose of 1gram MgSo4 per hour for 6 hours.
15864158|NCT03928678|Procedure|enhanced recovery after surgery program in colorectal cancer surgery|to determine the feasibility of implementation of the ERAS protocol in our institute and its impact on hospital length of stay and outcome of surgery.
15864159|NCT03928626|Behavioral|Regulation of craving|Participants in the ROC-T condition will be trained to use a strategy that instructs them to think of the negative outcomes associated with alcohol drinking while looking at alcohol-related images.
15864160|NCT03928626|Behavioral|Control (NO REGULATION)|In the CONTROL condition, participants would simply observe non-alcohol-related images and allow natural responses to come
15864161|NCT03928613|Behavioral|tablet based Cognitive Training based on location information|Participants perform Tablet based Cognitive training using interactive voice services and tags three times (minimum 30 minutes per time) a week for 6 weeks
15864162|NCT03928600|Combination Product|Cervical Foley combined with Misoprostol|Placement of cervical Foley catheter along with application of vaginal misoprostol 25ug that will be repeated 4/4h until 150ug
15864163|NCT03928600|Drug|Dinoprostone 10mg insert OR|Application for 24h of Dinoprostone 10mg insert
15864164|NCT03928600|Drug|Misoprostol|Application of vaginal misoprostol 25ug 4/4h until 150ug
15864165|NCT03928587|Dietary Supplement|2 billion CFU in total of the two strains Lactobacillus paracasei subsp. paracasei and Lactobacillus rhamnosus and arginine.|One lozenge once daily for 12 months
15864166|NCT03928587|Dietary Supplement|Placebo|Placebo once daily for 12 months
15864167|NCT03928574|Procedure|Ultrasound-Guided Plane Block|Ultrasound-Guided Plane Block Medial Brachial Cutaneous and the Intercostobrachial Nerves
15864168|NCT03928574|Procedure|Conventional Block|Conventional Block Medial Brachial Cutaneous and the Intercostobrachial Nerves
15864169|NCT03928561|Device|Active intense Pure Air XL air cleaner|Cat allergen is nebulized in the EEC. When the concentration is stable, air cleaners are switched on. The number of air cleaners placed in the EEC is defined according to the volume of the EEC and the air renewal. Patients are exposed to cat allergen in the presence of active air cleaners in the EEC
15864170|NCT03928561|Device|Placebo Intense Pure Air XL air cleaner|Cat allergen is nebulized in the EEC. When the concentration is stable, placebo air cleaners are switched on. The placebo effect is obtained thanks to the removal of air cleaners filters prior to the exposure. The number of placebo air cleaners placed in the EEC is defined according to the volume of the EEC and the air renewal. Patients are exposed to cat allergen in the presence of placebo air cleaners in the EEC.
15864202|NCT03928353|Drug|Ticagrelor Oral Tablet - Pre-Treatment|Ticagrelor 180 mg + 90 mg BID for 5 doses prior to PB2452 or Placebo
15864273|NCT03927833|Device|Phototherapy lights|Phototherapy lights used continuously or timed, following an algorithm based upon TSB levels.
15864171|NCT03928535|Device|High-FlowNasal Cannula|High-flowoxygenwas applied immediately after extubation through specific nasal cannula. Flow was initially set at 10 L/min and titrated upwards in 5-L/min steps until patients experienced discomfort.Temperature was initially set to 37°C, unless reported too hot by patients, and FIO2 was regularly adjusted to the target peripheral capillary oxygen saturation (SPO2) of greater than 92%. After 24 hours, high-flow was stopped and, if necessary, patients received conventional oxygen therapy.
15864172|NCT03928535|Device|Noninvasive Ventilation|Full face mask NIV was continuously delivered immediately after extubation for a scheduled period of 24 hours after extubation. Afterward, NIV was withdrawn and oxygen was administered by Venturi mask.Both PEEP and inspiratory pressure supportwere adjusted to target a respiratory rate of 25/min and adequate gas exchange (arterial oxygen saturation [SaO2] 92%, with pH of 7.35). The FIO2 was adjusted to maintain SPO2 at less than 92%. Sedatives to increase tolerance to NIV were not allowed.
15864173|NCT03928522|Drug|hand mixed vancomycin|hand mixed vancomycin powder into cement
15864174|NCT03928522|Drug|hand mixed tobramycin|hand mixed tobramycin into cement
15864175|NCT03928522|Device|pre-mixed tobramycin|this cement is already pre-mixed with tobramycin
15864176|NCT03928509|Other|No intervention|No intervention
15864177|NCT03928496|Drug|AbobotulinumtoxinA|Subjects were injected with 0.1 ml (12.5 units of Abobotulinumtoxina) into 31 distinct muscle locations in the head and neck
15864178|NCT03928496|Drug|Normal saline|Subjects were injected with 0.1 ml of preservative free normal saline into 31 distinct muscle locations in the head and neck
15864179|NCT03928483|Behavioral|Modified WW Food program|Participants will receive a structured, holistic, behavioral weight management program that encourages development of healthy habits to help individuals eat healthier, move more, and shift to a more helpful mindset.
15864180|NCT03928470|Drug|EsoDuo Tab. 20/800mg|Nexium Tab. 20mg
15864181|NCT03928457|Other|Parental questionnaire|Parental questionnaire on pregnancy history and environmental exposure
15864182|NCT03928457|Other|Daily continuous recording of radiofrequency exposure levels|Daily continuous recording of radiofrequency exposure levels (6 weeks) by placing a dosimeter inside the incubator
15864183|NCT03928457|Other|Follow-up of daily infants environmental and clinical parameters|Follow-up of daily infants environmental and clinical parameters: morphological characteristics, drugs, ventilatory support, dietary management, clinical outcomes, incubator data (temperatures…)
15864184|NCT03928457|Other|Nocturnal polysomnography|Nocturnal polysomnography (at 3 and 6 weeks of life, between 8 pm and 8 am) with recording of sleep (electroencephalography, electrooculography),
15864185|NCT03928457|Diagnostic Test|cerebral hemodynamics|cerebral hemodynamics (near infrared spectroscopy)
15864186|NCT03928457|Diagnostic Test|activity of the autonomic nervous system|activity of the autonomic nervous system (electrocardiography, analysis of heart rate variability)
15864187|NCT03928444|Procedure|intradermal injection of adipose derived stem cells to one side of the face|"Lipoaspiration for preparation of ADSC will be done according to the following technique:
~Under local anesthesia using strict aseptic technique, a small incision will be done in the lateral aspect of the thigh or lower abdomen, through which the infiltration cannula will be introduced to inject the local anesthetic solution using the wet technique. This will be followed 15 minutes later by lipo-aspiration of (50 ml fat ) using a blunt tipped cannula under the negative suction pressure of a 60 ml syringe.
~Autologous adipose tissue derived stem cells (At-ADSCs) will be separated from the lipo-aspirate using enzymatic digestion and differential centrifugation in the Center of Excellence for Research in Regenerative Medicine and its Application (CERRMA), Alexandria Faculty of Medicine.
~Viability of collected cells will be checked using trypan blue stain. Characterization of the isolated ADSCs population will be performed by flow cytometry."
15864188|NCT03928444|Procedure|intradermal injection of saline to one side of the face|intradermal injection of saline to one side of the face
15864189|NCT03928431|Other|Maternal microbiota|See arm descriptions
15864190|NCT03928418|Behavioral|In-person counseling session|Brief alcohol reduction counseling is provided by a trained counselor to the study participant at the HIV clinic during two sessions that are 3 months apart.
15864191|NCT03928418|Behavioral|Live phone call booster session|Brief alcohol reduction counseling booster sessions every 3 weeks delivered via a live phone call from a trained counselor to the study participant given within 3 months and in between two in-person counseling sessions.
15864192|NCT03928418|Behavioral|Technology (IVR or SMS) booster session|Brief alcohol reduction counseling booster sessions once to twice a week delivered via a choice of interactive voice response (IVR) or short message service (SMS) phone technology to the study participant given within 3 months and in between two in-person counseling sessions.
15864193|NCT03928405|Other|Exercises with Nintendo Wii virtual reality device|In the first session, each Nintendo Wii components were introduced to each individual. The selected games and how they were played were taught to each individual by the physiotherapist and practically taught. The games were played with the help of physiotherapists in the first session so that individuals could transfer the correct weight on the Nintendo Wii balance board and to use the game console's control. The patient was supported with verbal and physical feedback when the patient played incorrectly during the games in the next sessions. Games that require serious balance and coordination were considered as a difficult activity for the patient and were not used in this study. The difficulty of the games was set to the simplest level for each patient. As the patients were successful the games' difficulty level was upgraded. The difficulty of the games has been increased according to the classification determined by the Nintendo Wii device.
15864194|NCT03928392|Behavioral|SCUBA with Occupational Therapy (OT)|Study participants will complete two OT sessions in conjunction to their regular SCUBA diving activity. OT intervention includes breathing techniques, mindfulness strategies and a journal activity.
15864195|NCT03928392|Behavioral|Self-Contained Underwater Breathing Apparatus (SCUBA) without OT|Study participants will continue their regular SCUBA diving activity through the Wounded American Veterans Experience SCUBA (WAVES) program. They will complete two dives.
15864196|NCT03928379|Drug|LY3305677|Administered SC
15864197|NCT03928379|Drug|Placebo|Administered SC
15864198|NCT03928366|Drug|Propofol|sedation
15864199|NCT03928366|Drug|Remifentanil|remifentanil
15864200|NCT03928353|Drug|PB2452 Infusion|30 minute - 24 hour infusion
15864201|NCT03928353|Drug|Placebo - Sodium Chloride|30 minute - 24 hour infusion
15864203|NCT03928353|Drug|Ticagrelor Oral Tablet - Pre-Treatment and Post-Treatment|Ticagrelor 180 mg + 90 mg BID for 5 doses prior to PB2452 or Placebo and Ticagerlor 180 mg 24 hours following PB2452 or Placebo
15864204|NCT03928353|Drug|Ticagrelor Oral Tablet - Pre-Treatment|Ticagrelor 180 mg BID for 5 doses prior to PB2452 or Placebo
15864205|NCT03928353|Drug|PB2452 Infusion|30 minute - 16 hour infusion
15864206|NCT03928353|Drug|Placebo - Sodium Chloride|Placebo - Sodium Chloride
15864207|NCT03928340|Drug|Metformin|"40 patients will be treated with metformin
~(1 gm twice daily (with the 2 main meals)), combined with insulin therapy"
15864208|NCT03928340|Drug|Insulin|40 patients will be treated with insulin alone. (Insulin dosage will be adjusted according to endocrinological recommendations)
15864209|NCT03928327|Drug|TAK-788|TAK-788 Capsules
15864210|NCT03928327|Drug|Itraconazole|Itraconazole Oral solution
15864211|NCT03928327|Drug|Rifampin|Rifampin Capsules
15864212|NCT03928314|Drug|ORIC-101|ORIC-101 once daily, 5 or 7 days/week, for 21 days of each 28-day cycle
15864213|NCT03928314|Drug|Nab-paclitaxel|75 or 100 mg/m2 Days 1, 8, and 15 of each 28-day cycle
15864214|NCT03928301|Behavioral|Wholetones Music|Participants listened to the Wholetones music for 10 nights consecutively. Participants began playing the music 30 minutes before going to bed and were asked to allow it to play continuously throughout the night.
15864215|NCT03928301|Behavioral|Classical Music|Participants listened to the classical music for 10 nights consecutively. Participants began playing the music 30 minutes before going to bed and were asked to allow it to play continuously throughout the night.
15864216|NCT03928288|Drug|Cabergoline 0.5 MG|Medication
15864217|NCT03928288|Drug|Placebo - Cap|Placebo capsule
15864218|NCT03928275|Biological|Interleukin-2|IL-2 is prepared as 4 million International Units (IU) per 0.8ml at a total dose of 500,000 IU in 0.1ml of sterilized saline (0.9%, m/v)/lesion.
15864219|NCT03928275|Biological|Combination therapy Interleukin-2 and Bacillus Calmette Guerin|"BCG (OncoTICE solutions 1-8 x 10-8 Colony Forming Units (CFU)) will be administered at a maximum dose of 3.2 million CFU per treatment at a maximum of 1.6 million CFU per lesion (max 2 lesions).
~IL-2 is prepared as 4 million International Units (IU) per 0.8ml at a total dose of 500,000 IU in 0.1ml of sterilized saline (0.9%, m/v)/lesion (in remaining lesions)."
15864220|NCT03928262|Biological|Benralizumab|Treatment 1: Benralizumab single dose, Treatment 2: Benralizumab single dose and Treatment 3: Benralizumab single dose subcutaneously administration on 36 healthy Chinese male and female subjects in 1:1:1 ratio.
15864221|NCT03928249|Dietary Supplement|Eriocitrin|"A crossover, double-blind, randomized, placebo-controlled clinical study with a duration of 26 weeks will be performed. All individuals and the principal investigator will remain blind to treatment until all analyzes are completed.
~Participants will be invited to attend 12-hour fasting to measure glucose levels, glycated hemoglobin and to perform the glucose tolerance test, in addition to an individual interview (Appendix B) to confirm eligibility according to the inclusion and exclusion criteria . The collection of blood and the glycemic curves will be performed at the beginning of the first, 12th, 14th and 26th week in the Laboratory of Clinical Analyzes ( Araraquara)
~At the beginning of the first, 12th, 14th and 26th week the following anthropometric parameters will be evaluated: body weight (kg), muscle mass (kg), fat mass (kg), body fat (%) (InBody 720, Biospace, Tokyo, Japan ) and waist-hip ratio."
15864222|NCT03928236|Other|Limited Intraoperative Benzodiazepine|policy for limited use of intraoperative benzodiazepine
15864223|NCT03928236|Other|Liberal Intraoperative Benzodiazepine|policy for liberal use of intraoperative benzodiazepine
15864224|NCT03928223|Other|exploratory survey on Itch modification by color viewing|"Patients relate their itch to a color of the Manchester Color Wheel (MCW) and choose a color of the MCW aimed at counteracting their itch. They complete the ItchyQoL (German version), which is a standard tool to assess itch-related quality of life. Then patients look at their antipruritic monochrome color for five minutes on a lap-top screen. Itch intensity (0-10 NRS) will be assessed at baseline and again after the patients looked at this color for 5 minutes."
15864225|NCT03928210|Drug|Digoxin|Patients will receive a daily maintenance dose of digoxin. The daily dose of digoxin will be calculated according to the renal function and the target serum digoxin concentration and applied in an adjusted regimen based on the availability of 0.125 mg and 0.25 mg pills in the morning (before 10 am). Blood samples for analyses of mean CTC cluster size will be drawn at screening, on day 0 (2 hrs after first oral intake), on day 3 and on day 7. Depending on the digoxin serum level maintenance therapy with digoxin will be continued up to 3 weeks if the digoxin serum level on day 7 or day 14 is below 0.70 ng/ml. For the third week of maintenance therapy individual dose adjustments will be carried out as needed.
15864226|NCT03928197|Behavioral|Tilt Test|Volunteers need to lay down for 15 minutes and afterwards stand up for 15 minutes
15864227|NCT03928197|Device|Inbody S10|Bio-electrical impedance measurement every 5 minutes
15864228|NCT03928197|Device|Tape measurements|Every 5 minutes, circumference of every leg is measured using a tape measure
15864229|NCT03928197|Device|SOMNOtouchTMNIBP, Vivisol, Belgium|Continous measurement of blood pressure, heart rate and saturation
15864230|NCT03928184|Drug|Lorecivivint|Healthcare professional-administered intra-articular injection; performed on Day 1
15864231|NCT03928184|Drug|Placebo|Healthcare professional-administered intra-articular injection; performed on Day 1
15864232|NCT03928171|Other|Intra-abdominal pressure during laparoscopy|Insufflation pressure of the abdomen during laparoscopy
15864233|NCT03928158|Drug|LCZ 696|50-100-200 mg tablet
15864234|NCT03928158|Drug|Valsartan|40-80-160 mg tablet
15864235|NCT03928145|Drug|Chlorthalidone 25 mg|Chlorthalidone 25 mg taken orally in the morning for 12 weeks.
15864236|NCT03928145|Drug|Hydrochlorothiazide 50 mg|Hydrochlorothiazide 50 mg taken orally in the morning for 12 weeks.
15864237|NCT03928145|Drug|Amiloride 20 mg|Amiloride 20 mg taken orally in the morning for 12 weeks.
15864238|NCT03928145|Drug|Amiloride 10 mg|Amiloride 10 mg taken orally in the morning for 12 weeks.
15864239|NCT03928132|Behavioral|CPD Workshop on Depression and Diabetes|2 parallel face-to-face onsite workshops on diabetes and depression in primary care given by experts in French (control and experimental) using Powerpoint presentations.
15864272|NCT03927846|Behavioral|Nurse-guided Web-based Cognitive Behavioral Therapy|nurse contact is to support and enhance participants' motivation to engage in the web-based CBT program.
15864240|NCT03928119|Behavioral|public education and network construction|Publication education includes multiple methods of acute myocardial infarction knowledge education. Network construction includes regional connection of ST-Segment Elevation Myocardial Infarction patients transfer for percutaneous coronary intervention treatment, as well as physicians skill improvement in primary hospital.
15864241|NCT03928106|Other|pharmacists' recommendation|For patients in the intervention group, upon identification of drug discrepancies, pharmacist responsible for enrollment will be intervened by contacting the responsible clinician using a structured written consult form. The number of accepted recommendations by the clinicians will be documented and recorded. When the researcher suggests resolving an identified discrepancy and the responsible clinicians accept the suggestion will be called an accepted recommendation (just an acceptance without any correction), if the accepted suggestion is implemented then this will be called implemented recommendation.
15864242|NCT03928093|Drug|Pregabalin|Pregabalin /placebo capsules will be taken by mouth and will be prescribed for the study participants in the doses, depending on their weight and treatment phase: Participant < 25 kg at baseline will start with 50 mg per day, increasing the dose by 50 mg each week until their maximum dose 200 mg per day; Participants who are greater than or equal to 25 kg at baseline will start with 100 mg per day, increasing their dose by 50 mg each week until their target dose 300 mg per day is achieved. The study medication will be taken twice per day.The dose will be weaned down every 1-2 days by 25 mg in the last two weeks of each treatment period.
15864243|NCT03928080|Diagnostic Test|Bleeding on brushing|Index tests are bleeding on brushing and aMMP-8 Gold standard: clinical diagnosis performed by specialist
15864244|NCT03928067|Behavioral|PNF + SAF|Personalized normative feedback (PNF) to correct misperceived peer drinking norms abroad + sojourner adjustment feedback (SAF) to promote cultural engagement abroad.
15864245|NCT03928054|Other|Kinesio Taping and therapeutic alliance|bandage used in the treatment of orthopedic diseases and the technique of therapeutic approach in the known patient with therapeutic alliance
15864246|NCT03928041|Device|Device: EVOS Lumbar Interbody System (EVOS-HA)|All subjects will receive the EVOS Lumbar Interbody System (EVOS-HA) device if according to the investigators opinion they are clinically indicated to have surgery treatment for degenerative disc disease and spondylolisthesis.
15864247|NCT03928028|Behavioral|Cognitive Remediation Therapy|Cognitive Remediation Therapy (CRT) is an adjunctive treatment focused on increasing set-shifting ability and developing meta-cognition.
15864248|NCT03928028|Behavioral|Family Based Treatment|Family Based Treatment (FBT) is an evidence based treatment in which parents are responsible for adolescent re-nourishment. They play an active role in treatment and their self-efficacy to make decisions regarding their child's treatment is empowered.
15864249|NCT03928015|Drug|Adjunctive dronabinol|5mg BID and adjusting within the range of 2.5mg - 10mg BID, minimum of 48 hours, as an adjunct to systemic analgesics
15864250|NCT03928015|Drug|Systemic analgesics|multimodal analgesia including opioid and non-opioid analgesics
15864251|NCT03928002|Other|4D Flow magnetic resonance imagery|acquisition of anatomical, volume, right ventricular remodeling and intracardiac flow information
15864252|NCT03928002|Procedure|Cardiac catheterization|pulmonary vascular resistance calculation ;
15864253|NCT03927989|Behavioral|Text messaging plus nicotine replacement therapy|Brief advice to quit smoking prior to lung cancer screening (LCS), 8 weeks of gain-framed, LCS-tailored text messages, and nicotine replacement therapy.
15864254|NCT03927989|Other|Standard Care at Lung Cancer Screening|Brief advice to quit smoking prior to lung cancer screening
15864255|NCT03927976|Behavioral|Path2Quit - culturally specific text message intervention|SMS text delivers over 6 weeks with links to 20-120 second video clips from PTF. The message library contains 155 videos and assessment questions. First message is tailored to wake-up times, and the topic of the video (e.g., Never Quit Quitting) accompanies the text. Messages are pushed to participants 1-2 times/day, with 24/7 access to messages pulled from 3 keywords (HELP1, JONES, SLIP). Participants also receive inquiry texts, designed to push videos of interest/relevance to the individual. The cultural adaptations are infused throughout the video segments. Topics include deep structure: race and smoking in general, African American smoking statistics; norms for smoking; concerns about nicotine replacement/medication; family/collectivism; unique stressors; racism/discrimination, depression; co-morbid addiction; neighborhood/environmental influences; menthol cigarettes; race-specific weight issues and concerns; and working as a community against the tobacco industry.
15864256|NCT03927963|Drug|Dexmedetomidine|Dexmedetomidine 0.7 ug/kg/h with sevoflurane 0.5 MAC and remifentanil infusion are used throughout anesthesia period
15864257|NCT03927963|Drug|Propofol|Effect site concentration of propofol 1.5 ng/ml with sevoflurane 0.5 MAC and remifentanil infusion are used throughout anesthesia period
15864258|NCT03927950|Drug|escitalopram|escitalopram 10-20mg per day 12 weeks
15864259|NCT03927950|Drug|bupropion|bupropion 150-300mg per day 6 weeks
15864260|NCT03927937|Procedure|AUTOTRANSPLANTATION TOOTH|Tooth with imposible prognosis is replace with a healthy tooth from the same patient.
15864261|NCT03927924|Procedure|High-intensity focused ultrasound|Energy employed to exert its effect through thermal and mechanical destruction of cancer tissue
15864262|NCT03927911|Drug|EXPAREL and Bupivacaine|Drug: EXPAREL and Bupivacaine HCl 0.5%
15864263|NCT03927911|Drug|Standard of Care|Standard of Care
15864264|NCT03927898|Drug|Toripalimab|Participants receive Toripalimab (240mg)/q3w till progression of disease after SBRT
15864265|NCT03927898|Radiation|Stereotactic Body Radiotherapy|Participants receive SBRT (BED>80Gy) to oligometastatic lesions followed by Toripalimab (240mg)/q3w
15864266|NCT03927885|Other|Placebo|Given open labeled placebo PO
15864267|NCT03927885|Other|Quality-of-Life Assessment|Ancillary studies
15864268|NCT03927885|Other|Questionnaire Administration|Ancillary studies
15864269|NCT03927885|Other|Waiting List|Assigned to a waiting list
15864270|NCT03927872|Other|blood biomarkers|assessment of serum BNP, D-Dimer and CK-MB and CRP and globulin /albumin ratio stroke outcome
15864271|NCT03927859|Other|a mail letter, a phone call and a phone call plus mailed letter|"All patients will be administered an intervention that will contain one or more of 3 possible interventions (a mail letter, a phone call and a mail plus phone call). Some patients will also be assigned into a condition where none of the interventions will be present.
~Patients at Black Creek CHC will only be offered a phone or a phone plus incentive intervention or a no intervention."
15864274|NCT03927820|Other|Benefits investigation|The study pharmacist will review the prescribed inhaler for 1) insurance coverage and 2) clinical appropriateness. The pharmacist will conduct a benefits investigation at time of hospital admission. The benefits investigation involves running test claims for inhalers to determine the most cost-effective inhaler for the patient's insurance plan. The study pharmacist will utilize clinical practice guidelines to assess appropriateness of the prescribed inhaler. Based on this review, the study pharmacist will submit a pharmacy consult to the inpatient pharmacist on the patient's healthcare team who will pend the inhaler orders (changing the patient's prescribed inhaler, if necessary) for the prescriber to send to the Meds to Beds discharge pharmacy. The Meds to Beds pharmacist will counsel the patient on inhaler use techniques prior to discharge.
15864275|NCT03927807|Drug|Misoprostol|"This study will include 150 pregnant women who fulfill the inclusion criteria and will be subdivided in two groups.
~Group1 will receive repetitive hourly dose of oral misoprostol solution equal to 10 microgram up to 12 doses or regular uterine activity.
~Group2 will receive oral misoprostol solution every two hours as 20 microgram up to 6 doses or regular uterine activity."
15864276|NCT03927794|Other|Self-Assembling Peptide P11-4|Self-Assembling Peptide P11-4 promotes subsurface biomimetic remineralization of enamel. It is a small peptide comprising 11 amino acids that when applied to an initial carious lesion diffuses into the body of the lesion, re-assembles itself into fibrils forming larger fibers and hence a 3-dimensional (3-D) matrix is formed. Natural remineralization driven by saliva is promoted through the surface of the P11-4 by increasing the surface area for calcium phosphate deposition. As a result, mineralization of the subsurface lesion occurs possibly due to the formation of de novo hydroxyapatite crystals on the surface of the P11-4 fibers.
15864277|NCT03927781|Drug|Pregabalin 300mg|One 300mg capsule will be administered PO 1 hour before surgery
15864278|NCT03927768|Diagnostic Test|Predictive Model|Anonymized, post-processed MRI imaging data will be analyzed to construct a model predicting benign vs malignant lesions. Model will be tested on a second cohort.
15864279|NCT03927768|Diagnostic Test|Breast Imagers|Anonymized research sequence with the addition of modeling data (Aims 1A and 1B) will be read by three blinded breast imagers and final evaluation compared to the full protocol.
15864280|NCT03927755|Other|Education|Physicians will undergo training on how to rapidly obtain appropriate images.
15864281|NCT03927742|Behavioral|Shade + app with messaging|Shade wearable device and application with UV messaging activated
15864282|NCT03927742|Behavioral|Shape + app without messaging|Shade wearable device and application without UV messaging activated
15864283|NCT03927729|Drug|Methoxyflurane|Pain will be treated with inhaled methoxyflurane (Penthrox®).
15864284|NCT03927716|Drug|SB206 12%|Topically once daily
15864285|NCT03927716|Drug|Placebo|Topically once daily
15864286|NCT03927703|Drug|SB206 12%|Topically once daily
15864287|NCT03927703|Drug|Placebo|Topically once daily
15864292|NCT03927677|Drug|Xanthine Oxidase Inhibitor|LC350189 200mg qd
15864293|NCT03927664|Other|Radiological assessment|Radiological assessment of findings in the peritoneum, omentum, mesentery, ascites and other abdominal findings
15864294|NCT03927651|Drug|ICG|Indocyanine green (ICG) is a Food and Drug (FDA)-approved tricarbocyanine dye that is fluorescent under near-infrared (NIR) light. ICG solutions for injection often contain sodium iodide. ICG is water soluble and when introduced intravenously, it is bound by plasma proteins, namely albumin. The intravascular half-life of ICG is 3-4 minutes with rapid hepatic clearance.
15864295|NCT03927638|Behavioral|sit/stand|Subjects will be asked to both sit and stand during a single trial.
15864296|NCT03927625|Drug|Ascorbate-Meglumine|Ascorbate, meglumine and sodium salt made by combining 375 mM sodium ascorbate, 125 mM ascorbic acid and 125 mM meglumine in sterile water for injection.
15864297|NCT03927612|Device|Virtual reality perspective taking training|Virtual reality system provides first-person perspective of a virtual social interaction in a school cafeteria as the subject attempts to complete a goal. A virtual counterpart interferes with this goal. In the alternate perspective condition, participants will then experience the scenario again from the counterpart's perspective, including internal thoughts of the virtual counterpart.
15864298|NCT03927612|Device|Virtual reality control perspective|Virtual reality system provides first-person perspective of a virtual social interaction in a school cafeteria as the subject attempts to complete a goal. A virtual counterpart interferes with this goal. In the control perspective condition, participants will then experience the scenario again from identical perspective.
15864299|NCT03927599|Other|Data Collection|Colleciton of data from medical records only
15864300|NCT03927586|Other|cognitive training|We will be using commercialized cognitive-based training programs in order to facilitate several cognitive functions. We will be targeting attention, recognition, color and shape identification, calculation, visual perception, visuospatial processing and executive function. Participants will perform tasks designed to enhance different types of cognitive functions. Cognitive program difficulty will be adjusted automatically and continuously based on each participant's level of performance.
15864301|NCT03927586|Other|physical exercise training|The physical exercise programs will involve balance or strength training or aerobic exercises. These may include (but not limited to) stepping, walking, dancing, ball kicking and throwing, and etc. The exercise session will be break up into 2 to 3 parts, and the participants can rest as needed during the exercise period. The exercise intensity will be progressed as the participants improve their performance throughout practice. To prevent exercise-induced injuries, vital signs and the Borg Perceived Exertion Scale will be monitored and recorded in each training session. If the training therapist observed that the exercise may be too intense for the participants, he/she will immediately reduce the training intensity.
15864302|NCT03927573|Drug|GEM3PSCA|Infusion of GEM3PSCA, administered intravenously, continuously over 7 days, 2 cycles
15864303|NCT03927560|Procedure|Robotic Assisted Percutaneous Coronary Intervention|Robotic Assisted Percutaneous Coronary Intervention
15864304|NCT03927547|Device|Inclined Sleep|Study participants randomized to the interventional arm will be instructed to sleep on inclined wedge mattress.
15864538|NCT03925779|Drug|Dexmedetomidine|dexmedetomidine sedation
15864539|NCT03925779|Drug|Propofol|propofol sedation
15864305|NCT03927534|Behavioral|Mindful Eating|The ME group will be composed by 7 weekly group sessions with a minimum duration of two hours, mixing theoretical contents with practices. Sessions will always be the same day of the week, except for bank holidays or eventualities, and will be conducted by a psychologist specially trained and certified in ME with experience in leading mindfulness groups. Group sizes will range between 10 and 12 participants. At the end of each session, participants will receive theoretical contents and homework activities to be practiced along the week.
15864306|NCT03927521|Procedure|Focal HIFU using PET-MRI/68Ga-PSMA imaging guidance|Focal HIFU treatment will be conducted with the Focal One® device using the PET-MRI/68Ga-PSMA imaging. The treatment area will be defined using PET-MRI/68Ga-PSMA imaging data and 3D biopsies.
15864307|NCT03927508|Drug|r-tPA|Pulse spray and infusion
15864308|NCT03927508|Device|The Bashir™ Endovascular Catheter|The Bashir™ Endovascular Catheter is a device intended for the localized infusion of therapeutic agents into the pulmonary artery and peripheral vasculature.
15864309|NCT03927495|Drug|KN046|Cisplatin+paclitaxel will be administered once every three weeks for four cycles. During the period of radiotherapy, KN046 will be administered once every two weeks until progressive disease, unacceptable toxicity or up to 2 years.
15864310|NCT03927495|Radiation|palliative radiotherapy|3D conformal radiation therapy will be administered for esophageal lesion or nearby lymph node. Stereotactic body radiation will be administered for metastatic lesion.
15864311|NCT03927495|Drug|KN046|Cisplatin+paclitaxel will be administered once every three weeks for four cycles. After completion of radiotherapy, KN046 will be administered once every two weeks until progressive disease, unacceptable toxicity or up to 2 years.
15864312|NCT03927482|Behavioral|CARES mobile smart phone app|The CARES smart phone mobile app contains a number of features to support safety while drinking and reduced alcohol consumption plus regular test messages for personal support
15864313|NCT03927482|Behavioral|Check Your Drinking|Check Your Drinking is an online alcohol assessment that provides normative feedback on the user's drinking habits relative to his/her peers. Alcohol interventions that provide normative feedback are rated by the NIAAA Alcohol Intervention Matrix as effective and low cost, and with few administrative or structural barriers to implementation thus making it suitable for community colleges.
15864314|NCT03927469|Other|age, sex, hemiplegic side, stroke duration, First hospitalisation duration (day)|This is a retrospiective descriptive study
15864315|NCT03927456|Drug|SHR6390|SHR6390 150 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
15864316|NCT03927456|Drug|Placebo|Placebo 150 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
15864317|NCT03927456|Drug|Fulvestrant|Fulvestrant 500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 for every cycle until progressive disease
15864318|NCT03927443|Drug|SDP-133|one drop
15864319|NCT03927443|Drug|Lumigan|one drop
15864320|NCT03927430|Procedure|pars plana vitrectomy with membrane peeling|23-gauge pars plana vitrectomy with peeling of the epiretinal and internal limiting membrane as well as air- or gastamponade
15864321|NCT03927404|Device|Active vacuum test prosthesis|The adaptive vacuum prosthesis is sold as a commercial device by the company Willow Wood with suggested U.S. L-Code L5781. The device is designated as a Class 1 Medical Device and 510(K) Exempt. This category is part of a low or moderate risk to patient safety and health. The Prosthetic socket system uses an active vacuum pump to push air out of the socket. The level of vacuum is controlled by hardware that automatically detects the socket fit based on in-socket motion and adjusts vacuum as needed to eliminate this motion.
15864322|NCT03927391|Drug|Enzalutamide|enzalutamide treatment
15864323|NCT03927378|Drug|S-ketamine|S-ketamine (0.2 mg/kg in 20 ml normal saline) is administered by intravenous infusion in 40 minutes after childbirth.
15864324|NCT03927378|Drug|Placebo|Placebo (20 ml normal saline) is administered by intravenous infusion in 40 minutes after childbirth.
15864325|NCT03927365|Device|Inhalation from a salt particle inhaler with or without content|Inhalation from inhaler with (active) or without (placebo) content
15864326|NCT03927352|Biological|SCT630|Administered by subcutaneous injection
15864327|NCT03927352|Biological|Adalimumab|Administered by subcutaneous injection
15864328|NCT03927339|Diagnostic Test|pre and post excercise group|"Treadmill Training Protocol
~Each eligible participant in the patients group was then prospectively assigned to undergo exercise session of full-body-free weight treadmill training. Once the participants were prepped, they performed stretching for 5 min and slow walking for 3 min as a warm-up exercise before starting the training. Stretch was carried out similarly to all the subjects to quadriceps femoris and the hamstring. In the warm-up time period , it was enforced for 3 min at the speed of1 km/h. Then patients began the walking trials and walked at 1 to 1.34 m/s on an electric car treadmill (JACO fitness: JACO-212C)."
15864329|NCT03927326|Drug|Exparel 266 MG Per 20 ML Injection|Liposomal bupivacaine
15864330|NCT03927313|Drug|Linezolid|For both experimental arms: 1.2g linezolid 28 days, followed by 600mg linezolid for 28 days
15864331|NCT03927313|Drug|High dose rifampicin|For both experimental arms: additional 25mg/kg (making a total of 35mg/kg) rifampicin, for the first 56 days of treatment
15864332|NCT03927313|Drug|Aspirin|For only one of the experimental arms: 1000mg of aspirin daily for 56 days.
15864333|NCT03927313|Drug|Standard of Care anti-tuberculous therapy|10mg/kg oral rifampicin, 5mg/kg oral isoniazid, 15mg/kg oral ethambutol, 25mg/kg oral pyrazinamide daily for 56 days.
15864334|NCT03927313|Drug|Dexamethasone|Dexamethasone according to doses of Thwaites criteria for the first 8 weeks of anti-tuberculous treatment. Doses differ according to participants Medical Research Council (MRC) grade. Given orally if participant can swallow and intravenously if they cannot.
15864335|NCT03927300|Device|Telemonitoring Software|Recovery of retrospective data in dialysis patients follow or not follow by a telemonitoring application.
15864336|NCT03927287|Diagnostic Test|Free PSA ratio test in patients after definitive treatment for localized prostate cancer|Free PSA ratio blood test done on biobank samples of patients after radical prostatectomy who developed biochemical recurrence.
15864337|NCT03927274|Drug|Topotecan|Intratumorally-administered topotecan using convection-enhanced delivery (CED) in patients with suspected recurrent/progressive High Grade Glioma (HGG) requiring stereotactic biopsy and is focused on investigating topotecan brain tissue distribution and determining the safety, toxicity, and tolerability of intratumorally-administered topotecan.
15864339|NCT03927248|Drug|Nivolumab|See description in Arms/Groups section
15864340|NCT03927235|Procedure|Transbronchial Cryobiopsy|Transbronchial Cryobiopsy in the Diagnosis of Diffuse Parenchymal Lung Diseases
15864341|NCT03927222|Biological|Human CMV pp65-LAMP mRNA-pulsed autologous DCs containing GM CSF|2x10^7 human CMV pp65-LAMP mRNA-pulsed autologous DCs are given intradermally and bilaterally at the groin site (divided equally to both inguinal regions). Patients will receive up to a total of 10 DC vaccines.
15864342|NCT03927222|Drug|Temozolomide|Temozolomide is a chemotherapy drug given to all enrolled patients at the post-RT clinic visit as dose-intensified TMZ (100 mg/m2/day for 21 days).
15864343|NCT03927222|Biological|Tetanus-Diphtheria Toxoid (Td)|Before the first DC vaccination, patients will receive 0.5 mL of Td (tetanus and diphtheria toxoids adsorbed) intramuscularly into the deltoid muscle to ensure adequate immunity to the tetanus antigen. Prior to pp65 DC vaccination #4,(3±1) weeks after leukapheresis 2 the vaccine site will receive a pre-conditioning intradermal injection of Td (1 flocculation unit (Lf), in 0.3 mL of saline for a total of 0.4 mL).
15864344|NCT03927222|Biological|GM-CSF|Granulocyte macrophage-colony stimulating factor (GM-CSF) is a sterile, white, preservative-free lyophilized powder in a vial containing 250 mcg that will be reconstituted in 0.5 mL of sterile water for injection and used as an adjuvant with the DC vaccine.
15864345|NCT03927222|Biological|111-Indium-labeling of Cells for in vivo Trafficking Studies|111-In-labeled DCs are 2 x 10^7 pp65-LAMP mRNA loaded mature DCs labeled with 111-In (50 μCi / 5 x 10^7 DCs) and given i.d. as the fourth vaccine. In up to 16 patients, the fourth vaccine will be labeled with 111-In (50 μCi / 5 x 10^7 DCs) prior to injection.
15864346|NCT03927209|Drug|BI 1467335|tablet
15864347|NCT03927196|Behavioral|extended counseling|Patients are handed out information leaflets on the correction of risk factors, SMS reminders, extended statins counseling.
15864348|NCT03927183|Other|person-centred practice|The structure and content of the intervention is constructed on principles for person-centredness. Each patients in the intervention are allocated a hospital-initiated nurse care manager during one year after surgery. Self-management support is primarily conducted between the patient and the nurse care manager. The primary goal of the support is to facilitate patients own resources in managing illness and health education on e.g. physical activity and diet. The support also comprises patient-held documentation and health plan. Other components of the intervention comprise accessibility and continuity which is secured by a structured clinical care pathway with planned care and defined care contacts. The patient has continuous access to the nurse care manager by telephone and face-to-face contact according to a structured follow-up plan. An interdisciplinary team as well as a patient education program constitutes distinct parts of the support during the year after surgery.
15864349|NCT03927170|Combination Product|Janumet XR tablet 100/1000 mg|To administrate the Janumet XR tablet
15864350|NCT03927170|Combination Product|GLH1SM tablet 100/1000 mg|To administrate the GLH1SM tablet
15864351|NCT03927157|Biological|Experimental: Tezepelumab|Tezepelumab subcutaneous injection
15864352|NCT03927157|Other|Placebo|Placebo subcutaneous injection
15864355|NCT03927131|Biological|QIV-IB|Inactivated split-virion quadrivalent influenza vaccine
15864356|NCT03927131|Biological|TIVV-IB|Inactivated split-virion trivalent Influenza Vaccine containing Influenza B virus - Victoria lineage
15864357|NCT03927131|Biological|TIVY-IB|Inactivated split-virion trivalent Influenza Vaccine containing Influenza B virus - Yamagata lineage
15864358|NCT03927131|Biological|QIV-IB Lot A|Inactivated split-virion quadrivalent influenza vaccine - Lot A
15864359|NCT03927131|Biological|QIV-IB Lot B|Inactivated split-virion quadrivalent influenza vaccine - Lot B
15864360|NCT03927131|Biological|QIV-IB Lot C|Inactivated split-virion quadrivalent influenza vaccine - Lot C
15864361|NCT03927118|Procedure|intravitreal dexamethasone implant application|Peripapillary RNFL thickness measurements and colored fundus photographs were compared before and 6 months after intravitreal DEX implant injection. The cup-to-disc ratios of fundus photographs were calculated using the Image-J program.
15864362|NCT03927105|Drug|Nivolumab|Nivolumab is a human monoclonal antibody (HuMAb; immunoglobulin G4 [IgG4]-S228P) that targets the programmed death-1 (PD-1) cluster of differentiation 279 (CD279) cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes.1 Binding of PD-1 to its ligands, programmed death-ligands 1 (PD-L1) and 2 (PD-L2), results in the down-regulation of lymphocyte activation. Inhibition of the interaction between PD-1 and its ligands promotes immune responses and antigen-specific T-cell responses to both foreign antigens as well as self-antigens. Nivolumab will be delivered intravenously at a fixed dose of 240 mg on day 1 of 14 day cycles.
15864363|NCT03927105|Drug|cabiralizumab|Cabiralizumab is a recombinant, humanized Immunoglobulin G4 (IgG4) monoclonal antibody that binds to human colony stimulating factor 1 receptor (CSF1R; c-fms). Cabiralizumab will be delivered intravenously at a dosage of 4 mg/kg on day 1 of 14 day cycles.
15864364|NCT03927092|Other|Multiple Sclerosis Knowledge Questionnaire|A 25-item self-administered questionnaire
15864365|NCT03927079|Biological|measure of intra-alveolar antibiotic concentration in µg/ml|included patients will have a broncho-alveolar lavage (BAL) to measure intra-alveolar antibiotic concentration, and a blood test to measure plasmatic concentration
15864366|NCT03927079|Procedure|broncho-alveolar lavage (BAL)|included patients will have a broncho-alveolar lavage (BAL) to measure intra-alveolar antibiotic concentration, and a blood test to measure plasmatic concentration
15864367|NCT03927079|Biological|blood test to measure plasmatic antibiotic concentration in µg/ml|included patients will have a broncho-alveolar lavage (BAL) to measure intra-alveolar antibiotic concentration, and a blood test to measure plasmatic
15864368|NCT03927066|Other|Assigned Interventions|Simulated hypovolemia by applied suction to lower extremities to cause venous pooling.
15864540|NCT03925779|Drug|Remifentanil|Remifentanil sedation
15864369|NCT03927040|Device|MemorEM 1000|The MemorEM 1000 device is self-contained and has been designed for in-home daily electromagnetic treatment in the radiofrequency range, allowing for complete mobility and comfort in performing daily activities during treatment. The device has a custom control panel that is powered by a rechargeable battery. This control panel/battery box is worn on the upper arm and wired to specialized emitters in the head cap worn by the subject. The device provides global treatment to forebrain. For each of the 120 days of in-home treatment, a single 1-hour treatment will be administered by the subject's caregiver, who will position the device on the patient's head and monitor treatment.
15864370|NCT03927027|Drug|Isosulfan Blue|Given SC
15864371|NCT03927027|Procedure|Axillary Lymph Node Dissection|Undergo ALND
15864372|NCT03927027|Procedure|Mapping|Undergo ARM
15864373|NCT03927027|Other|Quality-of-Life Assessment|Ancillary studies
15864374|NCT03927027|Other|Questionnaire Administration|Ancillary studies
15864375|NCT03927014|Other|thiol/disulfide levels|Venous blood will sample from the antecubital veins for measuring the serum concentration of thiol/disulfide levels. The serum thiol/disulfide levels will measure using commercially available reagent kits, which is produced to detect human thiol/disulfide levels (Rel Assay Diagnostics Gaziantep, Turkey). The thiol/disulfide levels measurements were performed in accordance with the company's protocol.
15864376|NCT03927001|Device|NeVa Stent Retrievers|mechanical neurothrombectomy
15864377|NCT03926988|Device|NeVa Stent Retriever|mechanical neurothrombectomy
15864378|NCT03926975|Device|Scleral Lens|The contact lens will be worn on one eye.
15864379|NCT03926975|Other|No lens|No lens worn on the contralateral control eye
15864380|NCT03926962|Drug|WCK 4873|100 to 1200 mg in tablets (the 100 mg dose cohort will receive half a tablet; higher dose cohorts will receive 1 or more tablets)
15864381|NCT03926962|Drug|Placebo Oral Tablet|Visually matching placebo
15864382|NCT03926949|Other|Parenteral Nutrition|Olimel 7.6% E 1000 ml will be infused over 4-5 hours at outpatient infusion clinic for 5-10 days within 14 days prior to surgery.
15864383|NCT03926949|Other|Standard Nutrition Care|Participants will receive nutrition therapy by registered dietitians within 14 days prior to surgery. Patients with SGA B and SGA C will receive advanced nutrition care and specialized nutrition care, respectively.
15864384|NCT03926936|Drug|Fulvestrant|intramuscular injection (2x 250mg), once every 2 weeks for the first month, and then monthly until completion of the study
15864385|NCT03926923|Other|no intervention|There will be no intervention. The blood sample is taken while a routine blood sampling.
15864386|NCT03926910|Diagnostic Test|Detection of hypovolemia using a ventricular stimulation without atrial pacing|"Upon the return in intensive care:
~Baseline measurements: 1) Three measurements of blood pressure during inspiration and 3 during expiration will be collected for averaging systolic blood pressure, diastolic blood pressure, mean arterial pressure and ΔPP. Data from a pulmonary artery catheter will be also collected.
~Realization of VESAP pacing with adjustment of the pacemaker (PM) at a heart rate 5 bpm higher than the heart rate of the patient. After 20 seconds of stimulation, recording of the blood pressure curve as done at baseline during at least 3 respiratory cycles,
~Then vascular filling with 500 ml of physiologic saline solution over 10 minutes and new set of measurement (same than at baseline)
~Second realization of VESAP pacing, and new set of measurement (same than at Baseline)
~Then, if the ΔPP is >10%, new vascular filling with 500 ml of physiologic saline solution over 10 min and new set of measurements as previously performed."
15864387|NCT03926884|Dietary Supplement|Three-seeds mixture|mixture of white mustard seeds, radish seeds and beefsteak plant (Korean perilla, a species of Perilla in the mint family, widely cultivated and edible for humans; a daily food for Korean people; many Japanese people drink as tea) seeds
15864388|NCT03926884|Dietary Supplement|Control|warm water with negligible amount of the three-seeds mixture
15864389|NCT03926871|Other|Ergonomic Training|The ergonomic training consisted of an educational program in Ergonomics with a duration of 60 (sixty) minutes divided into a theoretical exposition and videos of the occupational tasks performed by the workers themselves. Theoretical lecture covered topics such as ergonomics, human anatomy, worker health, prevention measures to minimize the risks of musculoskeletal diseases. A better way of performing the work to protect the musculoskeletal system was demonstrated.
15864390|NCT03926845|Other|Isobutylamido-thiazolyl-resorcinol Cream 0.2%|Each bottle contains Isobutylamido-thiazolyl-resorcinol cream 0.2% to be applied on the entire face twice daily for 12 weeks.
15864391|NCT03926845|Other|Vehicle|Each bottle contains vehicle cream to be applied on the entire face twice daily for 12 weeks.
15864392|NCT03926832|Device|Continuous Positive Airway Pressure (CPAP)|Continuous positive airway pressure (CPAP) is the gold standard for Obstructive Sleep Apnea Syndrome (OSAS) management when moderate-to-severe. Subjects with OSA will be trained in the use of CPAP and will be instructed to use it every night for 3 months. These subjects will then return for a post-treatment completion of questionnaires (ESS and FAS) and compliance analysis.
15864393|NCT03926819|Drug|HBI-002|Oral liquid carbon monoxide drug product.
15864394|NCT03926806|Other|Plain yoghurt|cups of 200 g yoghurt
15864395|NCT03926806|Other|Vitamin B yoghurt|cups of 200 g yoghurt
15864396|NCT03926793|Drug|GB002|GB002 low dose or high dose for inhalation
15864397|NCT03926793|Drug|Placebo|Placebo for inhalation
15864398|NCT03926793|Device|Generic Dry Powder Inhaler|Generic dry powder inhaler for GB002 or Placebo delivery
15864399|NCT03926780|Drug|Rivaroxaban 20 MG|38 Patients with evidence of LV thrombus as assessed by trans-thoracic echocardiography (TTE) will be assigned randomly to receive rivaroxaban 20 mg per day
15864400|NCT03926780|Drug|Warfarin Sodium|38 Patients with evidence of LV thrombus as assessed by trans-thoracic echocardiography (TTE) will be assigned randomly to receive warfarin sodium by a dose starting from 3 mg per day and titrated accordingly to target an INR of 2-3
15864401|NCT03926767|Other|Pain Neuroscience Education (PNE)|A power-point presentation with metaphors and animated videos will be employed. The PNE program will be held in 2 sessions of 30 minutes each. The intervention program will be divided into 17 thematic topics according to Explain Pain.
15864402|NCT03926767|Other|Orofacial Manual Therapy|A protocol of Orofacial Exercises and Manual Therapy will be adopted in the present study. The manual therapy techniques will be: Intraoral temporalis release, Intraoral medial and lateral pterygoid (origin) technique and Intraoral sphenopalatine ganglion technique.
15880345|NCT03802331|Drug|BI 1323495,|single oral doses
15864403|NCT03926767|Other|Orofacial Exercises|Two mandibular exercises: Mandibular body-condylar cross-pressure chewing technique and Post-isometric relaxation stretches-laterotrusion and opening. Each exercise will be executed 10 times per session for 10 seconds.
15864404|NCT03926767|Other|Neck Motor Control Exercises|A protocol of neck motor control protocol will be adopted in our study. The exercises included bracing exercises (six hierarchical levels) in neurodevelopment stages for the cervical spine. Extremity range of motion exercises will be conducted while maintaining a stable spine at the specific positions. Also, cervical isometric exercises (five hierarchical levels) will be carried out directly forward, obliquely, toward right and left, and directly backward by maintaining a stable spine with elastic resistive bands. Finally, exercises also included functional training with elastic resistance and exercise balls on unstable surfaces (eight hierarchical levels). The criteria to progress in each exercise domain (bracing, isometric exercises or functional training) will be sustain the contraction for 10 seconds, 10 times.
15864405|NCT03926754|Drug|Mirabegron|"Study A The maximum tolerated dose up to a maximum of 300 mg per day for 26 weeks.
~Study B One single dose of 300 mg at day one followed by 150 mg x 2 for 1 week (8-11 days)."
15864406|NCT03926741|Drug|GSNO|patient will use a nebulizer to inhale (breathe in) a solution of GSNO followed by repeated measurements of airway function (breathing tests)
15864407|NCT03926728|Biological|CTH522-CAF01 IM|On-site reconstitution of IMPs is performed by mixing 85 microgram CTH522 with CAF01. The preferred for IM is in the non-dominant deltoid muscle. IM injection will be performed with a 1-2 ml polypropylene Luer-Lok™ syringe via 23-25-gauge needle. The identity of the injected trial vaccine will be known to the clinical site staff dispensing and/or injecting the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial.
15864408|NCT03926728|Biological|CTH522-CAF09b IM|On-site reconstitution of IMPs is performed by mixing 85 microgram CTH522 with CAF09b. The preferred for IM is in the non-dominant deltoid muscle. IM injection will be performed with a 1-2 ml polypropylene Luer-Lok™ syringe via 23-25-gauge needle. The identity of the injected trial vaccine will be known to the clinical site staff dispensing and/or injecting the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial.
15864409|NCT03926728|Biological|CTH522 ID|24 microgram CTH522 given ID is in the non-dominant deltoid muscle. ID with a 1 ml syringe via a 26-28 gauge needle using a NanoPass device or similar. The identity of the injected trial vaccine will be known to the clinical site staff dispensing and/or injecting the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial.
15864410|NCT03926728|Biological|CTH522 TO|24 microgram CTH522 (12 microgram in each eye) TO administrations will be performed using a Gilson positive displacement pipette. The identity of vaccine will be known to the clinical site staff dispensing/administrating the trial vaccine to the subject and by the unblinded trial monitor. The identity of the trial vaccine administered will remain unknown to the subject during the trial.
15864411|NCT03926728|Biological|Placebo (Saline)|Placebo only given as IM, ID and TO
15864412|NCT03926715|Other|Nutritional status|
15864413|NCT03926702|Drug|Radiopharmaceuticals|All subjects will receive radiopharmaceutical for positron-emission tomography (PET) scan.
15864414|NCT03926689|Behavioral|SMS messages|A package of at least monthly SMS messages delivered to all adults in households with an individual in the 1000-day period between pregnancy and a child turning 2 years of age.
15864415|NCT03926689|Behavioral|Standard SII SBCC|Home visits/IPC; community events including food demo and key life events; and Bhanchhin Aama radio program episodes
15864416|NCT03926676|Other|grandio blocks|nano hybrid composite blocks
15864417|NCT03926676|Other|emax|ceramic blocks
15864418|NCT03926663|Drug|Dexmedetomidine|"Dexmedetomidine, a potent α-2 adrenoceptor agonist, is approximately 8 times more selective toward the α-2 adrenoceptors than clonidine.
~Patients will receive 0.25% bupivacaine (with an average dose of 1-1.5 mg/kg) + 0.2 μg/kg dexmedetomidine preincisional local infiltration of the nasal mucosa."
15864419|NCT03926663|Drug|Bupivacaine|patients will receive 0.25% bupivacaine (with an average dose of 1-1.5 mg/kg) preincisional local infiltration of the nasal mucosa.
15864420|NCT03926650|Device|Masimo Sedline Monitor Patient State Index|Masimo Sedline Monitor shows frontal electromyography and patient state index, Train of four monitor shows muscle strength on adductor pollicis muscle
15864421|NCT03926637|Other|Multiple Sclerosis Performance Test (MSPT)|Administered as specified in the treatment arm.
15864422|NCT03926624|Drug|DFP-10917|DFP-10917 Powder for Injection. Active ingredient: 4-amino-1-(2-cyano-deoxy-β-D-arabinofuranosyl)-2(1H)-pyrimidinone monohydrochloride
15864423|NCT03926624|Drug|Cytarabine|cytosine arabinoside (ara-C)
15864424|NCT03926624|Drug|Azacitidine|Azacitidine
15864425|NCT03926624|Drug|Decitabine|Decitabine
15864426|NCT03926624|Drug|Mitoxantrone|Mitoxantrone
15864427|NCT03926624|Drug|Etoposide|Etoposide
15864428|NCT03926624|Drug|Fludarabine|Fludarabine
15864429|NCT03926624|Drug|Idarubicin|Idarubicin
15864430|NCT03926624|Drug|Venetoclax|Venetoclax
15864431|NCT03926624|Drug|Cladribine|Cladribine
15864432|NCT03926611|Drug|LOU064 Arm 1|Low dose of LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85
15864433|NCT03926611|Drug|LOU064 Arm 2|Medium dose of LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85
15864434|NCT03926611|Drug|LOU064 Arm 3|High dose of LOU064 orally in the morning (once daily) and matching placebo in the evening from Day 1 to 85
15864435|NCT03926611|Drug|LOU064 Arm 4|Low dose of LOU064 orally, twice daily from Day 1 to 85
15864436|NCT03926611|Drug|LOU064 Arm 5|Medium dose of LOU064 orally, twice daily from Day 1 to 85
15864437|NCT03926611|Drug|LOU064 Arm 6|High dose of LOU064 orally, twice daily from Day 1 to 85
15864438|NCT03926611|Drug|Placebo arm|Matching placebo, orally, twice daily from Day 1 to 85
15864439|NCT03926598|Behavioral|Patient and/or Family Member Intervention|On the Patient Login Screen, log in using your last name and session ID provided by the research team on the Surveys Screen, click on a pending survey when the survey opens, respond to the survey submit the survey log out of the Guide-Goals Application.
15864440|NCT03926598|Behavioral|Certified Diabetes Educator Intervention|On the Provider Login Screen, log in using the username and password provided by the research team on the Patients Screen, choose patient Will Owens on the Visit Status Screen, add comments needs to be followed up regarding ketosis education in the comments for provider text box on the Visit Status Screen, add a goal for the patient log out of Goals-to-Guide application.
15864441|NCT03926598|Behavioral|Physician Intervention|On the Provider Login Screen, log in using the username and password provided by the research team on the Patient Screen, add a new patient on the Edit Patient Screen, add the Diabetes Family Responsibility Questionnaire on the Edit Patient Screen, create a survey access code to share with the patient.
15864442|NCT03926598|Behavioral|Front Desk Staff Intervention|On the Provider Login Screen, log in using the username and password provided by the research team on the Patients Screen, choose patient Will Owens on the Visit Status Screen, add comments needs to be followed up regarding ketosis education in the comments for provider text box on the Visit Status Screen, add a goal for the patient log out of Goals-to-Guide application.
15864443|NCT03926598|Behavioral|Nurse Intervention|On the Provider Login Screen, log in using the username and password provided by the research team on the Patients Screen, choose patient Will Owens on the Visit Status screen, change HbA1C value to 10% on the Visit Status screen, change Nephropathy evaluation to Abnormal log out of Guide to Goals application.
15864444|NCT03926572|Other|A biobank will be created from blood samples taken at admission, days 3 and days 7|A biobank will be created from the blood samples taken on admission, days 3 and 7 of admission. The prognostic value of the preselected biomarkers will be analyzed and a proteomic analysis will be performed to identify new biomarkers. The prognostic value of these new biological parameters will be compared to the usual surveillance parameters that will be collected during the follow-up (clinical, echocardiographic and hemodynamic parameters)
15864445|NCT03926559|Drug|Morphine.|Pregnant patients with a perineal tear postpartum receive 2mg of morphine through their epidural. This will be a one time dose immediately postpartum.
15864446|NCT03926546|Behavioral|ERP for Individuals|Comparing Group vs. Individual ERP for OCD
15864447|NCT03926533|Other|Telehealth|Telehealth visits will be conducted from a private telehealth lab room in the Vanderbilt ICU Recovery Center using a live and interactive approach where providers and patients interact and communicate in real-time using Zoom, a secure video-conferencing platform recommended by Vanderbilt Telehealth.
15864448|NCT03926520|Device|Electroconvulsive Therapy (ECT)|Stimulus method of delivery will be RUL electrode placement, and ultra-brief (UB) pulse width (0.25-0.37ms). At the first ECT session, seizure threshold (ST) will be determined by titration with the empirical dose titration method and subsequent treatments will be approximately 6 times the ST. Following other NIMH sponsored multicenter ECT studies (PRIDE, U01 MH055495), stimulus settings will be adjusted as needed during the ECT course based on seizure quality and treatment efficacy. Participants will be administered anesthesia.
15864449|NCT03926520|Other|Simulated Electroconvulsive Therapy (S-ECT)|The participant is brought to the ECT suite for the length a session would normally take (approximately 2 hours). While in the ECT suite, conducting gel will be placed on the scalp of the S-ECT subjects to parallel the ECT procedures in the ECT active group. An IV will be placed to provide PRN medication and fluids as needed. IV placement will also provide a method for study staff to assess physical interference and subject resistance to treatment. Participants will not be administered anesthesia.
15864450|NCT03926507|Procedure|Computed Tomography|Undergo PET/CT scan
15864451|NCT03926507|Other|Fluciclovine F18|Given IV
15864452|NCT03926507|Procedure|Positron Emission Tomography|Undergo PET/CT scan
15864453|NCT03926481|Behavioral|Evaluate Healthy Lifestyle Program on cognitive outcomes|The healthy lifestyle program will be delivered once a week for 17 weeks as part as regular clinical care. It will include an group classes taught by health coaches and dieticians. These classes will focus on diet, exercise, and behavior modification. We plan 2 cohorts of 15 subjects (n=30). In-person research assistant-led assessments will occur at baseline and 17 weeks.
15864454|NCT03926468|Diagnostic Test|Liquid biopsy|Before onset of treatment, cell-free DNA (cfDNA) is extracted from venous blood sample for next-generation DNA sequencing (NGS) using a commercially available platform (Roche Foundation ACT) For this purpose, 4 x 10 ml of venous blood will be collected from each patient. Two tubes (Streck) will be sent to service provider (Roche), one tube will be used for droplet digital polymerase chain reaction (ddPCR, QX200 Droplet Digital PCR System, BioRad) and ddPRC/NGS analyses and one is collected and stored in Auria Biobank (www.auria.fi) for possible future analyses.
15864455|NCT03926455|Biological|Typhax (investigational typhoid fever candidate vaccine)|
15864456|NCT03926455|Biological|Placebo|Placebo is administered to the control group on Day 0 and 28
15864457|NCT03926455|Biological|Active Comparator Typhim Vi|A single dose of commercial typhoid fever vaccine Typhim Vi is administered on Day 0, followed by placebo control on Day 28
15864458|NCT03926442|Other|Italian Herb meal|Italian Herb in active breakfast meal
15864459|NCT03926442|Other|Cinnamon Meal|Cinnamon in active breakfast meal
15864460|NCT03926442|Other|Pumpkin Spice meal|Pumpkin Spice Mix in active breakfast meal
15864461|NCT03926442|Other|Placebo meal|Placebo in breakfast meal
15864462|NCT03926429|Other|Standardised data collection|The following variables will be retrospectively assessed by medical record review using a standardised data collection form:demographics; gender, age; family or personal history of spondyloarthritis, psoriasis, uveitis, inflammatory bowel disease; clinical presentation; mono, oligo or polyarthritis, dactylitis, inflammatory joint pain, enthesopathy, axial symptoms, fever, extra-articular manifestations (conjunctivitis, anterior uveitis, circinate balanitis, skin rash); time interval between infection and musculoskeletal manifestations; causal microorganism if known, or triggering event; HLA-B27; radiographic sacroiliitis; treatments and outcomes (complete recovery at one year follow-up, relapse within 6 months after onset, or spondyloarthritis according to the ASAS criteria).
15864463|NCT03926416|Biological|CodaVax-H1N1|Live-attenuated vaccine against influenza A H1N1, A/California/07/2009
15864464|NCT03926416|Biological|Fluzone quadrivalent|Fluzone® (QuadriFlu - TIV), inactivated, quadrivalent influenza vaccine
15864465|NCT03926403|Other|"State-Trait Anxiety Inventory (Spielberger Self-Assessment Questionnaire)"|"Patients will be given, a State-Trait Anxiety Inventory (Spielberger Self-Assessment Questionnaire) that will be collected on the same day. Each patient's initial anxiety score will be calculated so as to select only patients who are at least lightly anxious about their management (score ≥ 36)."
15864466|NCT03926403|Procedure|hypnosis techniques|Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from experimental management based on hypnosis techniques.
15864467|NCT03926403|Procedure|local anaesthesia|Patients requiring facial surgery under local anaesthesia in an ultra-short circuit will benefit from conventional management (local anaesthesia).
15864468|NCT03926390|Dietary Supplement|Bovine colostrum|bovine colostrum for first 2 weeks
15864469|NCT03926377|Procedure|bone densitometry|Patients with bullous pemphigoid will benefit from bone densitometry at the initiation of treatment, at 3 months (theoretical end of the treatment of attack) and at 6 months (theoretical end of the treatment).
15864470|NCT03926377|Biological|blood test|Blood test of serum calcium, phosphoremia, albumin, 25 OH vitamin D and cortisol at 8 hours to highlight possible correlations between changes in bone mineral density and phosphocalcic parameters and 8 hours cortisolemia.
15864471|NCT03926377|Procedure|radiographs of the thoracic and lumbar spine|standard radiographs of the thoracic and lumbar spine will be done at the initiation of treatment and at 6 months.
15864472|NCT03926377|Procedure|Clobetasol propionate|Clobetasol propionate (Dermoval® 0,5% cream), administered for 6 months.
15864473|NCT03926364|Other|Patients with referred pain|The project does not affect treatment or does not offer any intervention.
15864474|NCT03926351|Dietary Supplement|Omega-3 capsules|BASF AS is the developer of the gelatine capsules containing Omega-3 ethyl ester from fish oil concentrate, as the dietary (nutritional) ingredient. The additional capsule fill ingredients are food additives permitted in food supplements according to Regulation (EC) No 1333/2008 on Food additives.
15864475|NCT03926351|Dietary Supplement|Olive oil|Soft gelatine capsule containing 1000 mg olive oil, refined.
15864476|NCT03926338|Drug|Neoadjuvant therapy with PD-1 inhibitor plus COX inhibitor|Toripalimab (IV given over 30 min at a dose of 3mg/m2 on day 1, every 2 weeks for 6 cycles) and Celecoxib (oral 200mg twice daily for 12 weeks) followed by colectomy
15864477|NCT03926338|Drug|Neoadjuvant therapy with PD-1 inhibitor|Toripalimab (IV given over 30 min at a dose of 3mg/m2 on day 1, every 2 weeks for 6 cycles) followed by colectomy
15864478|NCT03926312|Device|Smart device-based cardiac rehabilitation|A smart device coupled with remote monitoring will be used to increase physical activity of patients after myocardial infarction with a history of low physical activity.
15864479|NCT03926299|Device|FotonaSmooth SP® Spectro laser device|dual laser treatment with thermal Nd:YAG and ablative Er:YAG (Fotona medical device), 4 laser sessions 4-8 weeks apart.
15864480|NCT03926299|Drug|Clobetasol propionate 0.05% ointment|6 months standard treatment with topical steroid cream (high dose for the first two months, medium dose for the next two months, low dose for the last two months)
15864481|NCT03926286|Drug|FMP-30|FMP-30 containing frozen human fecal microbiota administered as (3) units of FMP30 enema on Day 0 and Week1
15864482|NCT03926260|Other|ctDNA analysis|blood sample at Baseline, 3weeks, 9 weeks after treatment, at progression if applicable
15864483|NCT03926247|Behavioral|Immigrant Well-Being Project|The IWP intervention emphasizes a sustainable and replicable partnership model between community-based organizations and universities that involves Mexican immigrants and undergraduate advocates working together to: a) increase immigrants' abilities to navigate their communities; b) improve immigrants' access to community resources; c) enhance meaningful social roles by valuing immigrants' culture, experiences, and knowledge; d) reduce immigrants' social isolation; and e) increase communities' responsiveness to immigrants through changes in policy and practice. The IWP is administered by university students enrolled in a service learning course, and has two elements: 1) Learning Circles, which involve cultural exchange and one-on-one learning opportunities, and; 2) Advocacy, which involves collaborative efforts to mobilize community resources related to health, housing, employment, education, and legal issues.
15864484|NCT03926234|Other|Four-level Chinese Emergency triage scale|a four-level category system, i.e. life-threatening (Level I), emergent (Level II), urgent (Level III) and semi-urgent (Level IV) . This system contains critical indicators (cardiac arrest, shock, and apnea), high risk indicators (ACS and DKA), single objective indicators (SBP, RR, HR, and SpO2) and MEWS (synthesis indicator). According to patients' health care problems, patients are rated by nurses into one of the four mentioned levels.
15864485|NCT03926221|Behavioral|Parent Behavior Change Intervention (PBC-I) and Transdiagnostic Sleep and Circadian Intervention (TranS-C)|PBC-I will be administered to the parent and TranS-C will be administered to the teenager. Both interventions are cognitive-behavioral and comprised of six weekly sessions. Parent and teenager sessions will be held in parallel.
15864486|NCT03926208|Procedure|Soak and Scrub|Betadine soak and scrub in addition to standard clorhexadine scrub (standard of care).
15864487|NCT03926208|Procedure|Clorhexadine scrub|Clorhexadine scrub (standard of care).
15864488|NCT03926195|Drug|Filgotinib|200-mg tablet administered orally once daily
15864489|NCT03926195|Drug|Placebo|Placebo to match filgotinib tablet administered orally once daily
15864490|NCT03926195|Drug|Standard of Care|Locally approved treatment, accepted by medical experts as a proper treatment for rheumatic conditions, prescribed according to best clinical practice, with no known testicular toxicity.
15864491|NCT03926182|Drug|AST2818 Tablets|AST2818 Tablets: Period 1 Fasted from 10 hours prior to dosing with 80 mg AST2818 tablet (p o, once) and 4 hours after dosing on day 1. Period 2 Allocated high-fat meal prior to dosing with 80 mg AST2818 tablet (p o, once) and fasted 4 hours after dosing on day 1.
15864492|NCT03926182|Drug|AST2818 Tablets|AST2818 Tablets: Period 1 allocated high-fat meal prior to dosing with 80 mg AST2818 tablet (p o, once) and fasted 4 hours after dosing on day 1. Period 2 fasted from 10 hours prior to dosing with 80 mg AST2818 tablet (p o, once)and 4 hours after dosing on day 1.
15864493|NCT03926169|Drug|Risankizumab|Risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS)
15864494|NCT03926169|Drug|Placebo for risankizumab|Placebo for risankizumab is administered as a subcutaneous (SC) injection in pre-filled syringe (PFS)
15864495|NCT03926156|Drug|Rivaroxaban|Rivaroxaban will be used as the anticoagulation drug for the intervention group. Rivaroxaban is an anticoagulant and the first orally active direct factor Xa inhibitor. Unlike warfarin, routine lab monitoring of INR is not necessary. However there is no approved antidote available in the event of a major bleed. Only the 10 mg tablet can be taken without regard to food. The 15 mg and 20 mg tablet should be taken with food
15864541|NCT03925740|Drug|MI Varnish|Application of MI varnish material versus the standard 1.23% APF.
15864496|NCT03926156|Drug|Warfarin|Warfarin will be used as the anticoagulation drug for the control group. Warfarin decreases blood clotting by blocking an enzyme called vitamin K epoxide reductase that reactivates vitamin K1. Without sufficient active vitamin K1, clotting factors II, VII, IX, and X have decreased clotting ability. The anticlotting protein C and protein S are also inhibited but to a lesser degree. A few days are required for full effect to occur and these effects can last for up to five days, and the final dose will be adjusted according to PT and related INR.
15864497|NCT03926143|Drug|BAY94-9343 (Anetumab ravtansine)|BAY94-9343 (Anetumab ravtansine) will be administered as specified in the parent studies
15864504|NCT03926117|Biological|Ziltivekimab|human IgG1k anti-human IL-6 monoclonal antibody
15864505|NCT03926091|Drug|Docetaxel|Docetaxel chemotherapy (injection)
15864506|NCT03926091|Drug|Cyclophosphamide|Cyclophosphamide chemotherapy (injection)
15864507|NCT03926078|Other|3D optical surface image|3D optical surface images will be acquired and used to calculate the EHI
15864508|NCT03926078|Radiation|Chest radiography|Chest radiographies will be acquired and used to calculated the HI and EHI
15864509|NCT03926078|Radiation|CT scan|CT scans will be acquired and used to calculate the HI and EHI
15864510|NCT03926065|Other|Plain Vegetables Served in 100% Portion Size|Lunch includes (a) vegetables without added flavoring (b) the baseline portion size of vegetables
15864511|NCT03926065|Other|Plain Vegetables Served in 200% Portion Size|Lunch includes (a) vegetables without added flavoring (b) 200% of the baseline portion size of vegetables
15864512|NCT03926065|Other|Enhanced Vegetables Served in 100% Portion Size|Lunch includes (a) vegetables with added flavoring (b) the baseline portion size of vegetables
15864513|NCT03926065|Other|Enhanced Vegetables Served in 200% Portion Size|Lunch includes (a) vegetables with added flavoring (b) 200% of the baseline portion size of vegetables
15864514|NCT03926052|Drug|Lisdexamfetamine Dimesylate|Participants randomly assigned to this arm will receive 12 weeks of LDX medication.
15864515|NCT03926052|Drug|Placebo|Participants randomly assigned to this arm will receive 12 weeks of an inactive placebo.
15864517|NCT03926026|Drug|Fluticasone Propionate|NCX 4251 Ophthalmic Suspension, 0.1%
15864518|NCT03926026|Drug|Placebo|NCX 4251 Ophthalmic Suspension, 0%
15864519|NCT03926013|Drug|JNJ-63898081|JNJ-63898081 will be administered.
15864520|NCT03926000|Drug|Pregabalin (PG)|Pregabalin 150 mg one hour before the procedure as premedication.
15864521|NCT03926000|Drug|Control placebo (C)|Placebo tablets one hour before the procedure as premedication.
15864522|NCT03925987|Behavioral|Exposure therapy|10 weekly sessions of group-based exposure therapy
15864523|NCT03925974|Drug|KN026 10 mg/kg QW|10 mg/kg QW as safety run-in dosage
15864524|NCT03925974|Drug|KN026 20 mg/kg Q2W|20 mg/kg Q2W as target dosage
15864525|NCT03925974|Drug|KN026 30 mg/kg Q3W|30 mg/kg Q3W as another target dosage
15864527|NCT03925948|Behavioral|PLAN 4 Success-Diabetes|The study intervention-PLAN 4 Success-Diabetes-consisted of four 1 to 1 ½-hour weekly health literacy training and disease knowledge education sessions for four weeks (4 in-person sessions), followed by two home visits and monthly phone counseling for over 6 months (5 phone sessions). The intervention is theory-driven and builds on von Wagner's model to incorporate key elements such as health literacy, disease knowledge, and self-efficacy for better glucose outcomes.
15864528|NCT03925935|Biological|AB-205|Engineered human umbilical vein endothelial cells
15864529|NCT03925909|Dietary Supplement|Eriocitrin|The responsible nutritionists will do 1) Anthropometric Assessment, in which weight data will be collected (kg); height (m); waist circumference (cm), waist circumference (cm) and hip circumference (cm), muscle mass (kg /%) and percentage of fat by means of bioimpedance equipment; 2) Dietary assessment, which will be performed through a 24-hour Food Recall, a 3-day Food Record and a Food Consumption Frequency Questionnaire; 3) Evaluation of the microbiota, for which stool will be collected from the last 24 hours on the day before the beginning of the experiment and at the end of the study (week 12); 3) Biochemical evaluation, which includes the collection of 30 mL of blood to be performed by trained and qualified technicians.
15864530|NCT03925896|Drug|LMP2 Antigen-specific TCR T cells|All enrolled subjects will be infused with EBV TCR-T cells. The project which enrolls 27 patients, according to the patient's HLA subtypes will be divided into HLA-A2, HLA-A11, HLA-A24 three groups, 9 patients in each group. Using a dose climbing method, each group will be divided into three dose subgroups. In the first dose subgroup, 5×106/kg TCR-T cells will be returned, and in the second dose subgroup, 1×107/kg TCR-T cells will be returned. The third dose subgroup 5 x 107/kg TCR-T cells will be returned.
15864531|NCT03925883|Behavioral|Patient navigation|Receive up to 6 live phone calls with a patient navigator for education, barrier assessment, and barrier resolution to follow up colonoscopy
15864532|NCT03925870|Drug|KN046|Eligible subjects will be enrolled and receive KN046 (3 mg/kg) monotherapy treatment until progressive disease according to RECIST 1.1, unacceptable toxicity, completion of 2 years' KN046 treatment, or withdrawal of informed consent, whichever comes first
15864533|NCT03925857|Biological|Allocetra-OTS|Allocetra-OTS contains allogeneic donor mononuclear enriched cells in the form of a liquid suspension with at least 40% early apoptotic cells. The suspension is prepared with Ringer's lactate solution.
15864534|NCT03925844|Other|Classification according to the cardiovascular risk|All patients are cognitively assessed at the beginning of the study and their cardiovascular risk is calculated. After 5 years of follow-up, patients are re-evaluated cognitively and their cardiovascular risk is recalculated.
15864535|NCT03925818|Drug|Bismuth Subcitrate Potassium|Pylera capsules
15864536|NCT03925818|Dietary Supplement|Gastrus|Gastrus 1 tablet
15864537|NCT03925792|Behavioral|Lifestyle Medicine|diet, sleep, exercise and mindfulness
15864542|NCT03925740|Drug|PreviDent Varnish|Application of PreviDent Varnish material versus the standard 1.23% APF.
15864543|NCT03925740|Drug|1.23% APF|Standard 1.23% APF application
15864546|NCT03925714|Other|life style|life sryle control only
15864547|NCT03925714|Drug|Metformin|metformin twice daily
15864548|NCT03925714|Drug|Nigetella salivata|NS twice daily
15864549|NCT03925701|Drug|Vildagliptin|vildagliptin twice daily
15864550|NCT03925701|Drug|vildagliptin\metformin|vildagliptin\metformin twice daily
15864551|NCT03925675|Drug|PET/CT with F-Fluciclovine (Axumin)|Comparison between PET/CT, MRI / MRS imaging, and biopsy histopathology. Data from each modality will be analyzed separately as described above to determine tumor recurrence and/or presence of radiation changes. Different metabolic profiles measured in areas of imaging changes and depicted by PET imaging will be characterized. Biopsy locations from stereotactic MRI data will be co-localized with PET/CT and MRSI to correlate biopsy histopathology with MRI+, MRSI+ and PET+ lesion data.
15864552|NCT03925662|Drug|Folfox with avastin|Folfox with avastin only
15864553|NCT03925662|Drug|Mebendazole|Folfox with avastin with mebendazole
15864554|NCT03925649|Biological|HB-adMSCs|single infusion of HB-adMSCs
15864555|NCT03925636|Dietary Supplement|Specific Carbohydrate Diet|The diet removes all grains such as wheat, barley, corn, rice, and most dairy products (except yogurt fermented for 24 hours and cheese aged for grater than 30 days). The diet mainly consists of meat, fruits, vegetables, nuts, oils, and honey.
15864556|NCT03925623|Other|Novel approaches for the design of child resistant closures|"Two novel designs for child resistant closures are tested.
~One is sized based on the anthropometric properties of adults and children's hands such that it should disallow children from engaging the system and enable adults (the physically based design strategy). The other replicates the first design, but is sized such that either of the two populations should be able to engage the closure.
~In testing this way, we begin to differentiate the paradigm that holds the children out (the cognitively based design strategy-- they do not understand and/or a physical one- they are unable to use the closure).
~Results (proportion of children opening within the first or second five minute periods of test and time to opening during the same) from each of these, will be compared to results from the third treatment, a standard, commercially available push and turn system."
15864557|NCT03925597|Dietary Supplement|Fiber supplement|3 week sequential supplementation with each fiber supplement
15864558|NCT03925584|Other|Music Therapy|Standardized music playlist will be played centrally at the subjects head or feet for a period of 20 minutes once during a 12-hour shift for 14 days or until mechanical ventilation has been discontinued, whichever is first
15864559|NCT03925571|Other|musicotherapy|If the patient is randomized in the experimental group, he listens the Music-care® playlists and chose two closed to his musical tastes. The playlists are unique compositions create by Music-care® (french company), not known from the general public, categorized by theme (jazz, rock, world music…).
15864560|NCT03925558|Dietary Supplement|Probiotics|
15864561|NCT03925558|Dietary Supplement|Placebo|
15864562|NCT03925545|Device|FluidVision AIOL|Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject
15864563|NCT03925545|Device|AcrySof IQ monofocal IOL|Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject
15864564|NCT03925545|Procedure|Cataract surgery|Standard cataract extraction with phacoemulsification
15864565|NCT03925532|Biological|Denosumab|Given SC
15864566|NCT03925519|Other|Supervised aerobic exercise|
15864567|NCT03925493|Behavioral|Graded Exercise Stress test (GXT) with Target Heart Rate Range|Patients assigned to one of two intervention groups will complete a GXT prior to the 4th CR session. The GXT will be completed in Baystate Medical Center's stress lab using standard protocols. This test will be used to set the target heart rate range, which will guide exercise intensity for the remainder of exercise training in cardiac rehabilitation.
15864568|NCT03925493|Behavioral|Heart rate monitors|Heart rate monitors (HRM) will be given to half of the patients randomly assigned to exercise stress testing group. Patients will receive a polar heart rate chest strap and polar watch. Patients will be asked to wear both, the chest strap and the watch during cardiac rehabilitation. Ultimately, we hope that the use of HRM is not necessary, but it may be needed to assure that patients in the THHR are able to consistently know their HR and adjust their exercise prescription. This will also increase the likelihood that there is a difference in heart rates between the THRR group from the RPE group.
15864569|NCT03925480|Drug|Azithromycin 500 mg Oral Tablet x 4|A single prophylactic dose of antibiotic given during labour
15864570|NCT03925480|Drug|Matching Placebo|Matching Placebo
15864571|NCT03925467|Other|Acupuncture|"Proximal acupoints: disposable acupuncture needles will be inserted into acupoints (GB34, SP9, EX-LE2) bilaterally for a depth of 10-30 mm.
~Distal acupoints: disposable acupuncture needles will be inserted into acupoints (LI11, HT3, TE10) bilaterally for a depth of 10-30 mm.
~Sham acupoints: Sham acupuncture needles will be administered into sham acupoints RN12, ST21."
15864572|NCT03925428|Drug|Entinostat|Given PO
15864573|NCT03925428|Drug|Molibresib|Given PO
15864574|NCT03925402|Drug|Ertapenem|Ertapenem injection
15864575|NCT03925402|Drug|Carbapenems|Other carbapenems injection
15864577|NCT03925376|Procedure|Redo cardiac surgery|Redo cardiac surgery is technically challenging due to scarring of tissues resulting in loss of tissue planes, adhesions, multiple comorbid factors and risk of injury during re-entry.Suggested techniques in coronary artery surgery with a left internal mammary artery include routing the graft through a slit in the pericardium to minimize the possibility of adherence to the sternal table.
15864578|NCT03925363|Device|Physical activity mobile-application|The active group will be given the feedback app and the control group the blind app
15864632|NCT03925103|Procedure|2D VATS lobectomy|pulmonary lobectomy carried out by video-assisted thoracoscopic surgery with a 2 dimensional display system
15864633|NCT03925090|Drug|Cisplatin+Toripalimab|chemotherapy and monoclonal antibody
15864580|NCT03925337|Device|Computer Aided Diagnostic Software|The research software is deep learning algorithm used to aid in the detection of polyps (abnormal tissue growths in the wall of the colon and adenomas (pre-cancerous growths) during colonoscopy. In its current form, the automatic polyp detection system is installed on a computer system unit that utilizes an an operating system.
15864581|NCT03925324|Biological|Human Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)|Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) 1.5 million cells/kg
15864582|NCT03925324|Other|Placebo|1.5 mL/kg Lactated Ringer's Solution
15864583|NCT03925311|Procedure|endometrial biopsy and blood sampling|patient will be performed endometrial biopsy and collected blood samples at particular time points
15864584|NCT03925285|Drug|Bevacizumab-800CW|Two to four days prior to surgery bevacizumab-800CW will be administered intravenously
15864585|NCT03925272|Procedure|Collection of samples (blood, stool, etc.)|
15864586|NCT03925272|Genetic|Genetic determinants analysis|
15864587|NCT03925272|Procedure|Sample obtained after surgery performed in the context of care|
15864588|NCT03925259|Behavioral|Acceptance and Commitment Therapy|Acceptance and commitment therapy (ACT) is a 'third wave' behaviour therapy delivered on a one to one basis.
15864589|NCT03925246|Drug|Nivolumab|"Nivolumab (Opdivo) is a potent human monoclonal antibody (mAb) of the IgG4 isotype designed to directly block the interaction between Programmed Cell Death 1 (PD-1) and its ligands, Programmed Death Ligand 1 (PD-L1) and PD-L2.
~Nivolumab is administered by a 30 minutes intravenous infusion at dose of 240 mg every 2 (+/- 2 days) weeks for 8 cycles (4 months), followed by a dose of 480 mg administered by a 60 minutes intravenous infusion every 4 weeks (+/-3 days) (beginning at cycle 9) for a total therapy duration of 1 year (maximum 16 cycles of treatment) or until progression, death, unacceptable toxicity."
15864590|NCT03925233|Drug|Trastuzumab|Trastuzumab Injection
15864591|NCT03925233|Drug|Doxorubicin Hydrochloride|Doxorubicin Hydrochloride Injection
15864592|NCT03925233|Drug|Epirubicin hydrochloride|Epirubicin hydrochloride injection
15864593|NCT03925233|Drug|Fluorouracil|Fluorouracil injection
15864594|NCT03925233|Drug|Paclitaxel|Paclitaxel injection
15864595|NCT03925233|Drug|Gemcitabine|Gemcitabine injection
15864596|NCT03925233|Drug|Cisplatin|Cisplatin injection
15864597|NCT03925233|Drug|Recombinant Human Endostatin|Recombinant Human Endostatin Injection
15864598|NCT03925233|Drug|Pirarubicin hydrochloride|Pirarubicin hydrochloride injection
15864599|NCT03925233|Drug|Pyrrolidine|Pyrrolidine tablets
15864600|NCT03925233|Drug|Ixabepilone|Ixapilone Injection
15864601|NCT03925233|Drug|Tamoxifen citrate|Tamoxifen citrate tablets
15864602|NCT03925233|Drug|Vinorelbine tartrate|Vinorelbine tartrate injection
15864603|NCT03925233|Drug|Carboplatin|Carboplatin injection
15864604|NCT03925233|Drug|Methotrexate|Methotrexate injection
15864605|NCT03925233|Drug|Eribulin mesylate|Eribulin mesylate injection
15864606|NCT03925233|Drug|Toremifene citrate|Toremifene citrate tablets
15864607|NCT03925233|Drug|Anastrozole|Anastrozole tablets
15864608|NCT03925233|Drug|Letrozole|Letrozole tablets
15864609|NCT03925233|Drug|Exemestane|Exemestane tablets
15864610|NCT03925233|Drug|Fulvestrant|Fulvestrant injection
15864611|NCT03925233|Drug|Olaparib|Olapani pill
15864612|NCT03925233|Drug|Bevacizumab|Bevacizumab injection
15864613|NCT03925233|Drug|Apatinib mesylate|Apatinib mesylate tablets
15864614|NCT03925233|Drug|Pattozumab|Pattozumab injection
15864615|NCT03925233|Drug|Capecitabine|Capecitabine tablets
15864616|NCT03925233|Drug|Ear particles|Ear particles
15864617|NCT03925233|Drug|Aidi Injection|Aidi Injection
15864618|NCT03925233|Drug|Cyclophosphamide|Cyclophosphamide injection
15864619|NCT03925220|Behavioral|The SUPPER Project|Substance Use Promoted by Eating family meals Regularly
15864620|NCT03925220|Behavioral|Improving nutrition and physical activity among youth|A brief intervention focused on improving nutrition and physical activity among youth
15864621|NCT03925194|Drug|Anakinra|Application of Anakinra once daily for 28 days
15864622|NCT03925181|Behavioral|Counselling Group|All sessions will be based off of SAMHSA's recovery curriculum but tailored to the participants recovering from the ICU and their caregivers. Throughout the 6-weeks, the sessions will be holistic, strengths-based, hopeful, respectful, relational, and subjective, while emphasizing social relationships, social contexts, and meaning and purpose.
15864623|NCT03925168|Behavioral|Music therapy|Music therapy will be administered according to the Eyre (2008) decision tree model. According to this model, the patient chooses his or her preferred musical intervention at the beginning of each session. Choices include: sing songs, compose a song, listen to songs, play instruments, have an imagery experience, listen to music, improvise, and use music for relaxation.
15864624|NCT03925155|Drug|EZ scrub vaginal chlorhexidine 4% solution|Patients will be randomized to receive one of two solutions. Either chlorhexidine 4% solution or standard of care 10% provodine-iodine vaginal solution
15864625|NCT03925155|Drug|10% provodine-iodine vaginal preparation|Patients will be randomized to receive one of two solutions. Either chlorhexidine 4% solution or standard of care 10% provodine-iodine vaginal solution
15864628|NCT03925129|Device|high frequency TENS treatment|Treatment with high frequency for minimum of 1 hour after misoprostol administration
15864629|NCT03925129|Device|Sham TENS treatment|Treatment with sham TENS device for minimum of 1 hour after misoprostol administration
15864630|NCT03925116|Other|COntraceptive pathway|alternative way of aiding patients in deciding contraception method
15864631|NCT03925103|Procedure|3D VATS lobectomy|pulmonary lobectomy carried out by video-assisted thoracoscopic surgery with a 3 dimensional display system
15864635|NCT03925077|Other|Movement-to-Music|The M2M program has been developed for onsite instruction and will be repurposed into an eHealth version. The program is based on the positive effects of exercise and music on both physiological and psychosocial outcomes in people with disabilities. Investigators aim to advance our current M2M program by enabling more robust personalization features, allowing people with SCI to individualize their M2M program. Movement and tempo-based adaptations will also be available. A typical M2M session will consist of tailored movement routines starting with a warmup using range of motion exercises, followed by muscle strengthening, cardiorespiratory, and/or balance routines, and ending with a cool down emphasizing breathing and mindfulness.
15864636|NCT03925077|Other|Standard Exercise Training|The SET program is based on the NCHPAD 14-Weeks to a Healthier You program launched in 2008. Exercise videos including range of motion, muscle strengthening, cardio and balance routines performed both seated and standing have been developed and will be restructured for use in this study. The SET program will be delivered through the same platform as M2M.
15864637|NCT03925064|Other|myocardial performance index|fetal right ventricular myocardial performance index measured with tissue doppler
15864638|NCT03925051|Drug|Prolia®|mAb targeting RANKL. human monoclonal antibody targeting RANKL.
15864639|NCT03925051|Drug|CMAB807|human monoclonal antibody targeting RANKL.
15864640|NCT03925038|Behavioral|Augmented Care: Electronic Media Dashboard|A participant-specific dashboard that highlights patterns of patient electronic communication usage relevant to understanding participants' mental health will be developed and used to augment treatment as usual.
15864641|NCT03925038|Behavioral|Treatment as Usual|Participants will receive psychotherapy as treatment as usual.
15864642|NCT03925025|Drug|Magnesium Sulfate|Treatment in addition to standard therapy
15864643|NCT03925025|Drug|Nimodipine|Treatment in addition to standard therapy
15864644|NCT03925012|Behavioral|Intervention|
15864645|NCT03924999|Combination Product|Combined decongestive treatment (CDT) & Combined exercise|Combined decongestive treatment consists of manual lymphatic drainage and compression bandaging for 30 sessions.
15864646|NCT03924999|Combination Product|Intermittent pneumatic compression & Combined exercise|Intermittent pneumatic compression for 5 days a week, for 6 weeks (totally, 30 sessions).
15864647|NCT03924999|Combination Product|Combined exercise|30 minutes aerobic exercise program including treadmill training consisted of a 5-minute warm-up and cool-down period and 25-minute submaximal aerobic exercise 5 days a week, for 6 weeks. Exercise intensity was calculated from the initial 6MWT. Each session was completed with 15 minutes of strengthening and stretching exercises.
15864652|NCT03924973|Behavioral|ESDM followed by treatment as usual|"The intervention was ESDM, delivered by professionals, one therapist per child, 12 hours per week during 2 years.
~Then, they will receive the treatment as usual during 3 years in this current follow-up study.
~Precise description of the 2 years ESDM treatment can be found in the published protocol of IDEA.
~What is called treatment as usual is what the community can usually offer. That is what the control group in IDEA received.
~In IDEA-2, both control and interventional group of IDEA will receive treatment as usual during 3 years.
~Treatment as usual comprises of different types of interventions, such as speech pathology therapy, occupational therapy and other types of therapy more or less specific to ASD in the community.
~All the interventions received by the children will be monitored in IDEA-2. All different treatment approaches will be quantified (type, frequency, intensity and duration)."
15864653|NCT03924960|Behavioral|High-intensity interval training|Participants in this group will perform a 20-25 minutes of aerobic exercise with a maximum capacity of 3-4 minutes (HRmax 80-95%) and active recovery for 3-4 minutes (HRmax 30-50%), five exercise sessions per week for 6 weeks.
15864654|NCT03924960|Behavioral|Moderate-intensity continuous training|Participants in this group will perform a 30-45 minute ergometric cycling exercise at 65-70% of the measured maximum heart rate (HRmax), five exercise sessions per week for 6 weeks.
15864655|NCT03924960|Behavioral|Control|Usual care control group
15864657|NCT03924921|Other|autogenic training|autogenic training
15864658|NCT03924908|Behavioral|VRH|Patients will see a 3D film combined with a hypnotic voice during the entire procedure of dressing change
15864659|NCT03924908|Behavioral|VR|Patients will see a 3D film without any hypnotic voice during the entire procedure of dressing change
15864663|NCT03924882|Drug|Anlotinib|Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
15866279|NCT03911635|Procedure|URAGPI technique|the Urethral Advancement, Glanuloplasty and Preputioplasty
15864672|NCT03924830|Procedure|Bulk without surface sealant|Adhese SE self-etch adhesive system will be applied according to the manufacturer's instructions in 53 teeth.Then, the Tetric N-Ceram Bulk fill composite will be used in increments of no more than 4 mm, using the bulk restoration technique, and each increment will be photoactivated for 40 seconds.
15864673|NCT03924830|Procedure|Bulk with Biscover|Adhese SE self-etch adhesive system will be applied according to the manufacturer's instructions in 53 teeth.Then, the Tetric N-Ceram Bulk fill composite will be used in increments of no more than 4 mm, using the bulk restoration technique, and each increment will be photoactivated for 40 seconds. After the restoration is completed, biscover surface sealant will be applied according to the manufacturer's instructions.
15864674|NCT03924830|Procedure|Bulk with Permaseal|Adhese SE self-etch adhesive system will be applied according to the manufacturer's instructions in 53 teeth.Then, the Tetric N-Ceram Bulk fill composite will be used in increments of no more than 4 mm, using the bulk restoration technique, and each increment will be photoactivated for 40 seconds. After the restoration is completed, Permaseal surface sealant will be applied according to the manufacturer's instructions.
15864675|NCT03924804|Drug|Ringer's solution acetate|Intravenous infusion of 2 ml/kg Ringer's solution acetate within 1 hour after induction.
15864676|NCT03924804|Drug|Ringer's solution acetate|Intravenous infusion of 8ml/kg Ringer's solution acetate within 1 hour after induction.
15864677|NCT03924804|Drug|Ringer's solution acetate|Intravenous infusion of 16ml/kg Ringer's solution acetate within 1 hour after induction.
15864678|NCT03924791|Drug|Lidocaine|In combination with dexamethasone or methylprednisolone acetate
15864679|NCT03924791|Drug|Methylprednisolone Acetate|In combination with lidocaine
15864680|NCT03924791|Drug|Dexamethasone|In combination with lidocaine
15864681|NCT03924778|Behavioral|DASH diet|brief description
15864682|NCT03924778|Behavioral|standard American diet|describe
15864683|NCT03924765|Device|Powered hip exoskeleton|The study team will be testing a powered hip exoskeleton and its capability to improve locomotion in stroke survivors.
15864684|NCT03924752|Device|Powered hip exoskeleton|The study team will test a powered hip exoskeleton and its capability to improve locomotion.
15864685|NCT03924739|Behavioral|Nurse-coordinated integrated care model for AF|Participants in the intervention group will participate in a 13-week, nurse-coordinated integrated care model comprising the following care components intended to comprehensively address the needs of AF patients: 1) a risk profile assessment and shared decision-making regarding OAC use; 2) an empowerment-based educational module on AF self-care; 3) nurse-initiated telephone support; and 4) patient-initiated contact for professional advice.
15864686|NCT03924726|Procedure|Micro-osteoperforation (MOP)|Micro-osteoperforation technique is used to accelerate orthodontic tooth movement.
15864687|NCT03924713|Behavioral|Supportive services|Assessment of behavioral, medical, and social needs, development of individual goals and action plan, follow-up to assist and work to ensure identified needs/goals are met. CHWs use their professional judgement to assess how long follow-up is required.
15864688|NCT03924700|Procedure|Biportal endoscopy|Biportal endoscopic spine surgery (BESS)
15864689|NCT03924700|Procedure|Microdiscectomy|Using microscope for discectomy
15864690|NCT03924687|Behavioral|Acceptance and Commitment Therapy (ACT) bibliotherapy for chronic pain|"The intervention consisted of the book Libérez-vous de la douleur par la méditation et l'ACT (Dionne, 2014) and a participant workbook, along with two phone calls of approximately 15 minutes each and weekly e-mails presenting the week's content. Participants also had access to audio meditation exercises on the book's website (http://liberezvousdeladouleur.com/meditations/)."
15864691|NCT03924674|Other|Education, clinical decision support tools|"Interventions will include:
~Education (webinars) for physicians and nurses regarding AAP IVF guidelines, including evidence on safety of isotonic maintenance IVF
~Implementation of algorithms, ordersets and checklists to guide choice of IVF and clinical indications to start/stop IVF;
~Tools to promote discussion about timing and necessity of routine lab draws
~Education and feedback for physicians regarding costs and harms of routine lab testing"
15864692|NCT03924661|Device|Aortic Valve Replacement|SJM™ Masters Series Hemodynamic Plus (HP) 15mm aortic mechanical heart valve as a replacement device for patients with a diseased, damaged, or malfunctioning aortic valve
15864693|NCT03924648|Other|Endocan levels|Venous blood sample from the antecubital veins for measuring serum concentration of Endocan. The serum endocan level was measured using a commercially available ELISA kit, which is produced to detect human endocan levels with high sensitivity and specificity (Elabscience Biotechnology Inc., Houston, TX, USA). The endocan measurements were performed in accordance with company's protocol.
15864694|NCT03924635|Combination Product|SYMBICORT and salbutamol|Salbutamol is a short-acting β-agonist and SYMBICORT (fixed dose combination of inhaled corticosteroid plus long-acting β2-agonist) is an anti-inflammatory reliever for asthma. SYMBICORT will be given in a TURBOHALER. Salbutamol will be given in a pressurised metered dose inhaler.
15864695|NCT03924622|Device|Mepilex|Mepilex Border Sacrum dressing is a multi-layered soft silicone dressing that is a recommended strategy to augment standard nursing interventions (i.e., repositioning, offloading) to prevent pressure injuries. The dressing will be placed on the sacrum.
15864696|NCT03924622|Device|LiquiCell|LiquiCell is a thin layer of low-viscosity fluid contained in a series of bursa-like pouches. Baffles within each pouch channel the liquid to disperse pressure and the volume of liquid in the pouch is so small that there is no pressure-build up. LiquiCell is available commercially as a 36 X 18-inch mattress overlay (LiquiCell Shear Reducing Mattress Overlay) with a soft pliable top and a non-slip bottom. The overlay is positioned from the shoulders to below the hips to minimize shear.
15864697|NCT03924609|Diagnostic Test|Intensive screening / routine screening|Recommendation and results of bone imaging such as bone scan or PET/CT, or bone CT /MR are collected.
15864698|NCT03924596|Drug|AKBA-Incense (3-acetyl-11-keto-ß-boswellic acid)|AKBA-Incense 2 capsules daily, 30% 3-acetyl-11-keto-ß-boswellic acid, from ZeinPharma
15864699|NCT03924596|Drug|Potassium Sodium Hydrogen Citrate|Uralyt-U (Potassium Sodium Hydrogen Citrate, 10g orally in 3 divided doses with pH target 6.2-6.8 for Calcium Oxalate stones and 7.0-7.2 for Uric Acid stones)
15864700|NCT03924583|Diagnostic Test|Duplex ultrasonography|Ultrasound examination of whole vena cava venous system with central venous catheter inserted, using duplex US method to detect catheter related thrombosis
15864701|NCT03924570|Behavioral|IPASS|IPASS is behavioral package to improve transitions of care by providing a framework to hands off.
15864702|NCT03924557|Diagnostic Test|Genotype-guided Supportive Care|In this arm, supportive care will be administered based on the results of the genotype test.
15864703|NCT03924544|Drug|Decorin|Antifibrotic agent
15864704|NCT03924544|Drug|Mitomycin c|Antifibrotic agent
15864705|NCT03924531|Behavioral|Mindful Awareness Program|2-hour mindfulness training for 6 weeks.
15864706|NCT03924531|Behavioral|Health Promotion Program|Health Promotion Program
15864707|NCT03924518|Drug|Granisetron Hydrochloride|Granisetron will be diluted with 0.9% saline to ensure that the therapeutic drug and placebo are identical in appearance, and 50 ml syringes will serve as the containers for all intravenous drugs.
15864708|NCT03924518|Drug|Placebo（Normal saline）|therapeutic drug and placebo are identical in appearance, and 50 ml syringes will serve as the containers for all intravenous drugs.
15864709|NCT03924505|Behavioral|Implementation Manual with External Facilitation Intervention|Participating organizations will receive the implementation manual and the external facilitation (EF) intervention. The manual provides instructions for organizations wanting to implement a high quality naloxone program. The EF will assist syringe service programs to integrate naloxone delivery within their organization. As part of these efforts, we will use a measurement framework to understand naloxone delivery within SSPs along the four phases of the implementation process-exploration, preparation, implementation and sustainment (EPIS).
15864710|NCT03924505|Behavioral|Implementation Manual only|Participating organizations will receive the implementation manual.The manual provides instructions for organizations wanting to implement a high quality naloxone program.
15864711|NCT03924492|Drug|ZULRESSO (brexanolone) injection|ZULRESSO
15864712|NCT03924479|Device|PowerBreathe (Breathing muscle training)|The breathing muscle breathing training will consist of using the PowerBreathe training for 8 weeks. The PowerBreathe is an inspiratory pressure threshold trainer.The valve blocks the airflow until the threshold pressure is achieved by breathing in forcefully into the device.
15864713|NCT03924466|Drug|68GaNOTA-Anti-HER2 VHH1|Injection of the radiopharmaceutical and PET/CT 90 min post injection
15864714|NCT03924453|Diagnostic Test|Pearl Powered by Proov|Participants self test in their homes and report back data via uploading onto an app and taking surveys.
15864715|NCT03924440|Diagnostic Test|Proov (Ovulation Double Check) Test|Rapid response urine progesterone test strips, Proov (formerly named Ovulation Double Check
15864716|NCT03924427|Drug|BMS-986165|Oral tablet administration
15864717|NCT03924414|Drug|Zoledronic Acid 5Mg/Bag 100Ml Inj|Zoledronic acid 5mg/100 ml IV infusion: Zoledronic acid-5 mg (ZA) is an FDA approved therapy for men and postmenopausal women for the treatment and prevention of osteoporosis.
15864718|NCT03924414|Other|Placebo|Normal Saline 100 ml (placebo) IV infusion
15864719|NCT03924401|Drug|Abatacept|All patients will receive 8 doses of abatacept (10 mg/kg intravenously on days -1, +5, +14, +28, +56, +84, +112, and +150) in addition to conventional GVHD prophylaxis.
15864720|NCT03924388|Device|Epidural spinal cord stimulation|The measurements will be obtained in 2 positions of supine and ~ 70° upright adjusted by the tilt-up table.
15864721|NCT03924388|Device|Trnascutaneous electrical spinal cord stimulation.|The measurements will be obtained in 2 positions of supine and ~ 70° upright adjusted by the tilt-up table.
15864722|NCT03924362|Procedure|PCNL|Percutaneous Nephrolithotomy is a means of treating large kidney stone burdens.
15864723|NCT03924349|Device|ICG-coated clip|Tumor localization using ICG-coated clip prior to surgery
15864724|NCT03924336|Procedure|Advanced- platelets rich fibrin (A-PRF) + Open flap debridement (OFD)|Elevation of flap.Thorough debridement of the defects using curettes and ultrasonic scalers. Clinical measurements will be then recorded , one PRF of the required size will be filled into the intraosseous defect, and the other will be used to prepare the membrane that will be used to cover the defect as a barrier. The mucoperiosteal flaps will be repositioned and secured in place using4-0 silk sutures
15864725|NCT03924336|Procedure|Open flap debridement (OFD) alone|Elevation of flap.Thorough debridement of the defects using curettes and ultrasonic scalers. Clinical measurements will be then recorded. After debridement and intraoperative recordings, interrupted sutures using 4-0 silk sutures will be placed to reposition the flaps.
15864726|NCT03924323|Drug|Escitalopram|8-weeks of treatment followed by 1-week taper down period
15864727|NCT03924323|Other|Placebo|Matching oral administration of inactive substance once daily
15864728|NCT03924310|Device|FeetBack System Active|Commercially available hand prosthesis with feedback device turned on
15864729|NCT03924310|Device|FeetBack System Passive|Commercially available hand prosthesis with feedback device turned off
15864730|NCT03924297|Device|chilipad|Chilipad is a commercially available pad designed to be placed between the top of a mattress and bed sheets. It allows for precise temperature regulation in one's bed.
15864731|NCT03924284|Diagnostic Test|PB2 gene RT-PCR; NS gene RT-PCR|PB2 gene RT-PCR: RT-PCR targeting the PB2 gene of influenza A virus NS gene RT-PCR: RT-PCR targeting NS gene of influenza A virus
15864732|NCT03924271|Diagnostic Test|Iron deficiency testing|Blood sample for complete iron status
15864733|NCT03924258|Diagnostic Test|Iron status testing|Blood sample for iron status testing
15864734|NCT03924245|Drug|Entinostat|Given by mouth
15864735|NCT03924245|Drug|Olaparib|Given by mouth
15864736|NCT03924219|Other|CMV T cell Immunity Assay|Flow cytometry based assay quantifying IFN-gamma expression in T cells following CMV peptide stimulation (Viracor)
15864737|NCT03924206|Device|Smoke evacuation system|The smoke evacuation system removes the surgical smoke directly near the electrocautery tip, where it is generated
15864738|NCT03924193|Drug|Lisdexamfetamine Dimesylate|Participants randomly assigned to this arm will receive 12 weeks of LDX medication.
15864739|NCT03924193|Behavioral|Cognitive-Behavioral Therapy|Participants randomly assigned to this arm will receive 12 weeks of Cognitive-Behavioral Therapy
15864740|NCT03924193|Other|Combination LDX and Cognitive-Behavioral Therapy|Participants randomly assigned to this arm will receive 12 weeks of LDX and Cognitive-Behavioral Therapy
15864741|NCT03924180|Dietary Supplement|Dietary Supplement for PKU patients|For both treatment groups, the objective in total protein will be 1g / kg / day of ideal weight, in 3-6 doses / day, including natural proteins and supplemented by the products under study.
15864830|NCT03923465|Device|Bone substitutes application|Following the application of EMD, filling the bone defect with bone substitutes.
15864742|NCT03924167|Behavioral|Weaving Healthy Families Program|The Weaving Healthy Families program is created from integrating the widely disseminated, ecological, innovative, and culturally grounded Framework of Historical Oppression, Resilience, and Transcendence (FHORT) with the the Celebrating Families! evidenced-based program (EBP). The goal of this program is to reduce and postpone Alcohol and other Drug (AOD) use, decrease and prevent violence in families, and promote resilience and wellness (including mental health) among NA adults and youth. This intervention seeks to promote wellness by targeting key behavioral (AOD), mental/emotional (emotional regulation/anger management, cognitions, resilience), social and familial (healthy and safe relationships, the family environment, and parenting), cultural (values, traditions), and physical (nutrition) factors.
15864743|NCT03924154|Drug|RVT-1201|RVT-1201 600 mg immediate-release tablet
15864744|NCT03924154|Drug|Placebo|Inactive pill manufactured to mimic RVT-1201 600 mg immediate-release tablet
15864745|NCT03924141|Behavioral|Training in de-escalation|Will receive one hour of de-escalation training
15864746|NCT03924128|Device|Photobiomodulation|The Photobiomodulation device should cover the entire knee junction, with time of application from 6 to 8 minutes and device turned on.
15864747|NCT03924115|Device|Transmedial Psychoeducational Program to improve adherence full or partial (PS)|Intervention consists of a transmedial Psychoeducational Program, which includes cognitive, behavioral and affective aspects to generate knowledge and skills that improve self-efficacy in the elderly, it is a program based on communication in health. The proposed transmedial narrative will allow older adults to assemble information from messages arranged through various media, including audiovisual capsules that will be transmitted on screens located in the Health Center and the development of a mobile application incorporated in the cellular that will be delivered with a data plan for one year. This intervention is designed to strengthen the personal resources of the elderly (such as self-efficacy, empowerment, knowledge) that promote self-care in health.
15864748|NCT03924102|Drug|Cardiac Perfusion and Metabolism with [11C] Acetate PET/CT|A rest and stress imaging study will be conducted on the PET/CT scanner with [11C] Acetate.
15864749|NCT03924089|Dietary Supplement|Oral nutritional supplement with probiotics|Oral nutritional supplement specifically developed for undernourished hemodialysis patients enriched with functional nutrients (extra virgin olive oil, omega 3 fatty acids, whey protein, antioxidants and carnitine), with probiotics.
15864750|NCT03924089|Dietary Supplement|Oral nutritional supplement without probiotics|Oral nutritional supplement specifically developed for undernourished hemodialysis patients enriched with functional nutrients (extra virgin olive oil, omega 3 fatty acids, whey protein, antioxidants and carnitine), without probiotics.
15864751|NCT03924089|Other|Dietary recommendations|Dietary recommendations
15864752|NCT03924076|Dietary Supplement|UHT Milk + Lactobacillus plantarum IS-10506|125 ml UHT milk (+Lactobacillus plantarum IS-10506) given to treatment group
15864753|NCT03924076|Dietary Supplement|UHT Milk|125 ml UHT milk given to placebo group
15864754|NCT03924063|Device|Hemiverse|Implantation of the hemiverse shoulderprothesis
15864755|NCT03924050|Drug|TORIPALIMAB INJECTION(JS001 )|TORIPALIMAB INJECTION(JS001 ) or Placebo, 240mg/6ml/vial, Q3W,up to 2 years of treatment.
15864756|NCT03924037|Behavioral|Intergenerational Knowledge Sharing group|Participants will attend a CBPR developed 12-session individual treatment for suicidal behavior. In addition to receiving the 12-session individual treatment, participants that are assigned to the Intergenerational Knowledge Sharing group will attend 12 weekly groups taught by tribal elders that focuses on sharing knowledge about the tribe.
15864757|NCT03924037|Behavioral|Support group|Participants will attend a CBPR developed 12-session individual treatment for suicidal behavior. In addition to receiving the 12-session individual treatment, participants that are assigned to the support group will attend 12 weekly support groups led by a behavioral health specialist that focuses on social support of the youth.
15864758|NCT03924024|Device|Accelerated intermittent theta burst treatment|"All participants will receive accelerated intermittent theta-burst stimulation to the left DLPFC. Stimulation intensity will be standardized to 80% of resting motor threshold.
~Stimulation will be delivered to L-DLPFC using the Brainsway stimulator."
15864759|NCT03924011|Device|Photobiomodulation therapy (PBMT)|PBMT sessions will be planned 2x/week after RT.
15864760|NCT03924011|Device|Sham laser|Sham laser sessions will be applied 2x/week after RT.
15864761|NCT03923998|Drug|Neoadjuvant chemotherapy|Three weekly concurrent chemotherapy with cisplatin 100 mg /m2
15864762|NCT03923998|Radiation|Neoadjuvant radiotherapy|Preoperative radiotherapy over 5 weeks- Dose 180-200cgys per day/ total 4500 cgys
15864763|NCT03923998|Procedure|Resection and reconstruction|Resection and reconstruction of mandibular/maxillary segment with prefabricated fibular graft
15864764|NCT03923985|Dietary Supplement|Probiotic containing Lactobacillus Crispatus|1 tablet / day of probiotic (275 mg of live probiotic lactic ferments: 10 Mld L. fermentum (SGL 10), 10 Mld L. gasseri, 10 Mld L. casei, 10 Mld L. acidophilus, 10 Mld L. crispatus) during 2 months.
15864765|NCT03923959|Drug|Tranexamic Acid Injectable Solution|100 cc normal saline mixed with 1g of tranexamic acid in solution
15864766|NCT03923959|Other|Placebo|100 cc normal saline
15864767|NCT03923946|Behavioral|Compassion focused therapy|Compassionate Imagery intervention based on compassionate imagery exercises in The Compassionate Mind Workbook by Irons and Beaumont, 2017
15864768|NCT03923933|Drug|Chlorthalidone|Chlorthalidone
15864769|NCT03923933|Drug|Bumetanide|Bumetanide
15864770|NCT03923920|Procedure|Biopsy|During clinically-scheduled spinal stenosis surgery, ligamentum flavum tissue (which may contain surrounding tissue and subcutaneous fat) that is removed during the procedure will be sent to pathology to be analyzed with amyloid-specific staining.
15864771|NCT03923907|Behavioral|EIM intervention group|As in arm description
15864772|NCT03923894|Dietary Supplement|Blueberry Yeast Fermentation Freeze Dying Powder Extract|Blueberry Yeast Fermentation Freeze Dying Powder Extract 2.07 g/day for 8 weeks.
15864773|NCT03923894|Dietary Supplement|Placebo|Placebo 2.07 g/day for 8 weeks.
15864774|NCT03923881|Device|MSOT Acuity Echo|Optoacoustic imaging with the MSOT Acuity Echo
15864775|NCT03923868|Drug|D-0120|D-0120 monotherapy dose escalation, oral, multiple dose for up to 28 days
15864776|NCT03923855|Device|BTL-899|BTL-899 therapy
15864976|NCT03922282|Procedure|Gasless BABA|BABA robotic-thyroidectomy that is using elevation of flap instead of using carbon dioxide.
15864777|NCT03923842|Drug|Denosumab Inj 120 MG/1.7ML|Denosumab 120 mg sc on day -15, -8 and day 1, followed by Denosumab 120 mg sc q4wks + platinum based drugs q3wks + Gemcitabine 1250 mg/sm day 1,8 q3wks for 6 cycles. Denosumab 120 mg sc q4wks will continue for 12 months since chemotherapy end.
15864778|NCT03923842|Drug|Chemotherapy as clinical standard of care|platinum based drugs q3wks + Gemcitabine 1250 mg/sm day 1,8 q3wks for 6 cycles. Gemcitabine will continue for 12 months if the patient will not shown disease progression
15864779|NCT03923829|Drug|Zinc Sulfate|systemic administration of Zinc sulfate with scaling and root planing
15864780|NCT03923829|Procedure|scaling and root planing|scaling and root planing
15864781|NCT03923816|Drug|Conservative fluid strategy: 12 mL/kg/h of Lactated Ringer (LR).&Restrictive fluid strategy:6 mL/kg/h of Lactated Ringer (LR).|comparison of two intraoperative fluid strategies upon hepatic outcome in hepatobiliary surgery
15864782|NCT03923803|Diagnostic Test|C- reactive protein|the measurement will be done by chemileumeniscence
15864783|NCT03923803|Diagnostic Test|Pro calcitonin|the measurement will be done by chemileumeniscence
15864784|NCT03923790|Behavioral|Educational Packet|The patient will receive an educational packet.
15864785|NCT03923790|Behavioral|Phone call at 72 hours by discharge nurse navigator|Patients will receive a phone call at 72 hours by the discharge nurse navigator (standard of care) to assure that they have received their medications and follow-up appointments
15864786|NCT03923790|Behavioral|Telehealth visit at 7 days, 1 month, 3 months, and 5 months after discharge|A stroke prevention trained nurse practitioner or MD or social worker will review the participant's hospital records and depression, dietary, and sleep apnea screens,will reinforce the care plan based on patient-specific needs.They will counsel patients on salt reduction, the Mediterranean diet, and the importance of diet and exercise for stroke prevention.Along with the pharmacist they will also review the BP data to determine the need for medication adjustment and will discuss the side effects and interactions.The social worker will assess the need for medication assistance and other resources. The care plan will be shared with primary care providers (PCP)and patients will be referred to a PCP if they do not have one. The social worker will also will assist uninsured patients in applying for Texas County Indigent Care programs.
15864787|NCT03923790|Behavioral|Educational messages every other week|The messages will be sent to the participants cellular phones and will contain one of the following: a reminder to monitor BP, information from about lifestyle and diet for BP reduction, or a message from the pharmacist about medication adherence
15864788|NCT03923790|Diagnostic Test|BP monitoring by QardioARM with periodic transmission of BP data|Participants will be prompted to transmit BP logs through the telemonitoring device every 2 weeks until average BP is < 130/80, then monthly thereafter. Uncontrolled BP will prompt a call from the pharmacist to discuss medication adherence and the need for further titration.
15864789|NCT03923777|Other|Active Surveillance|Agreeing to postpone treatment while continuing with a CT scan surveillance regimen to follow tumor growth. SABR should be offered if either the tumor is >3 cm in size or the VDT decreases to <400 days.
15864790|NCT03923764|Dietary Supplement|High protein and energy diet|Intervention group receives nutritional counseling to increase protein and energy in their diet to reach their estimated protein need (1.3 g/kg). Kontrol group continues their usual diet.
15864791|NCT03923764|Other|Habitual Diet|Patients continue their usual diet
15864792|NCT03923751|Other|Invitation to regional anesthesia survey|An invitation letter sent to Head of Anesthesiology and Intensive Care Department of Polish Hospital
15864793|NCT03923738|Drug|Tocilizumab|TCZ will be administered by IV infusion at two dose levels Q4W. The maximum dose of TCZ that will be administered is 800 mg. The dose of TCZ infusion will be calculated on the basis of body weight measured prior to each infusion.
15864794|NCT03923725|Drug|Artemether-lumefantrine+ Amodiaquine (AL+AQ)|"AL: Currently available as dispersible tablets containing 20 mg of artemether and 120 mg of lumefantrine, in a fixed-dose combination formulation. The flavoured dispersible tablet paediatric formulation facilitates use in young children.
~The dose of artemether-lumefantrine is administered approaching the WHO-recommended target ranges of artemether 5-24 mg/kg and lumefantrine 29-144 mg/kg over 3 days.
~AQ: is available as dispersible tablets of 40 mg. The weight-based treatment schedule aims for a dosage of approximately 10mg (4.5-15mg)/kg/day amodiaquine for three days."
15864795|NCT03923725|Drug|Artemether-lumefantrine + placebo (AL+PBO)|"AL: Currently available as dispersible tablets containing 20 mg of artemether and 120 mg of lumefantrine, in a fixed-dose combination formulation. The flavoured dispersible tablet paediatric formulation facilitates use in young children.
~The dose of artemether-lumefantrine is administered approaching the WHO-recommended target ranges of artemether 5-24 mg/kg and lumefantrine 29-144 mg/kg over 3 days.
~PBO: Placebo tablets for amodiaquine are identical in size, shape and color to the amodiaquine tablets."
15864796|NCT03923725|Drug|Artesunate-mefloquine+piperaquine (AS-MQ+PPQ)|"AS: Artesunate will be administered according to an optimised dosing schedule using tablets of 32 or 100 mg artesunate with a dosing target of 4 mg/kg/day.
~MQ: Mefloquine will be administered according to an optimised dosing schedule using tablets of 70 or 220 mg mefloquine hydrochloride with a dosing target of 8.3 mg/kg/day.
~PPQ: Piperaquine will be administered according to an optimised dosing schedule using tablets of 160 or 500 mg of piperaquine tetraphosphate. The weight-based treatment aims for a dosage of approximately.
~24 mg/kg/day in patients <25 kg (range 16.0 - 32.0 mg/kg) piperaquine for three days, thereby approaching the WHO-recommended target range of 20 - 32 mg/kg per day.
~18 mg/kg/day in patients ≥25 kg (range 15.0 - 29.4 mg/kg) piperaquine for three days, thereby approaching the WHO-recommended target range of 16 - 27 mg/kg per day."
15864797|NCT03923725|Drug|Artesunate-mefloquine+placebo (AS-MQ+PBO)|"AS: Artesunate will be administered according to an optimised dosing schedule using tablets of 32 or 100 mg artesunate with a dosing target of 4 mg/kg/day.
~MQ: Mefloquine will be administered according to an optimised dosing schedule using tablets of 70 or 220 mg mefloquine hydrochloride with a dosing target of 8.3 mg/kg/day.
~PBO: Placebo tablets for piperaquine are identical in size, shape and colour to the piperaquine tablets."
15864828|NCT03923465|Procedure|Procedure: Periodontal surgery with entire papilla preservation (EPP) technique|After local anesthesia injection an modified flap is designed according to minimally invasive microsurgical techniques. After flap elevation, careful removal of granulation tissues from the periodontal defects is performed. Scaling and root planing of the involved dental roots is ensured and finally suture is placed.
15864829|NCT03923465|Device|EMD application|Application of Pref-Gel for 2 minutes and then the application of Enamel Matrix Derivatives (EMD) on the surgically exposed root surface.
15864798|NCT03923712|Behavioral|Supervised Exercise Programme|The methodology will be multicomponent, including aerobic, strength, coordination-cognitive and balance-agility. The physical exercise sessions will be designed in such a way that they work the dimensions but being attractive and motivating for the participants. Each session will include 10 minutes of warm-up with smooth running and mobility exercises; 35-40 minutes of aerobic, strength, coordination-cognitive and balance-agility progressively developed; and 10 minutes back to calm at low intensity with stretching exercises. Nutritional intervention will not be included. For quality purposes, we will use small groups (10-15 pers). After each session participants will be asked about their subjective perception of the effort and the intensity will be controlled by heart rate monitors.
15864799|NCT03923699|Device|Anesthesia Control Tower monitoring|Real time data will be monitored through the AlertWatch® system as well as the patient's EHR.
15864800|NCT03923686|Procedure|EUS-guided drainage using LAMS with DPS|Endoscopic ultrasound-guided drainage using lumen-apposing metal stent with coaxial plastic stent in the treatment of walled-off pancreatic necrosis.
15864801|NCT03923686|Procedure|EUS-guided drainage using LAMS alone|Endoscopic ultrasound-guided drainage using lumen-apposing metal stent without coaxial plastic stent in the treatment of walled-off pancreatic necrosis.
15864802|NCT03923673|Procedure|Pericardiotomy|The minimally invasive procedure that creates a small opening in the sac that surrounds the heart.
15864803|NCT03923660|Other|Incremental Concentric-eccentric exercise test|Patients will perform incremental exercise test on semi recumbent eccentric ergometer
15864804|NCT03923660|Other|Incremental Eccentric-concentric exercise test|Patients will perform incremental exercise test on semi recumbent concentric ergometer
15864805|NCT03923647|Device|Laparoscopy|Laparoscopic insertion with carbon dioxide via open technique at the umbilicus
15864806|NCT03923634|Device|Princess® RICH|Princess® RICH is injected into lateral canthal lines and/or perioral rhytids
15864807|NCT03923621|Procedure|EPSiT|Specialised fistuloscope to indentify sinus tracts, cautery tracts, remove causative hair, irrigation.
15864808|NCT03923621|Procedure|Excision|Surgery to remove all affected tissue, followed by wound closure.
15864809|NCT03923608|Diagnostic Test|Maximal muscle strength Test|1RM test performed in 5 different tools (Elastic Band, Pulley, halter, digital dynamometer and isokinetic dynamometer)
15864810|NCT03923608|Diagnostic Test|Exhaustion test|Test performed until individual exhaustion in 5 different tools (Elastic Band, Pulley, halter and isokinetic dynamometer)
15864811|NCT03923595|Other|Adherence intervention research|dedicated management
15864812|NCT03923582|Behavioral|Health Curriculum Training|"This is a randomized, controlled, single blinded, trial, stratified by health profession, of the intervention versus waitlist control assessing knowledge, attitude change and skill development. At the end of the intervention as compared with waitlist controls…
~Participants will significantly increase knowledge about sexual health and sexual health care.
~Participants will significantly improve attitudes about provision of sexual health services, sexual health communication skills, and comfort in addressing sexual health care in routine care.
~Participants' sexual health communication, history taking, and counseling skills will be significantly improved as assessed by independent evaluators blinded to trial assignment.
~Secondary analyses will assess whether at post-test, sexual health knowledge, attitudes and skills will vary by health discipline, and test for differential intervention effects by discipline."
15864813|NCT03923569|Diagnostic Test|Overnight polysomnography|Overnight polysomnography with evaluation of each form of epileptiform activity during each vigilance state and memory scores at the overnight retention test
15864814|NCT03923569|Diagnostic Test|blood sample|blood sample for genetic testing of the Apolipoprotein E
15864815|NCT03923569|Diagnostic Test|high-resolution MRI scan|Evaluation of anomalies in brain structure and functional resting state connectivity
15864816|NCT03923569|Behavioral|neuropsychological evaluation|neuropsychological evaluation including episodic memory tests before an overnight polysomnography
15864817|NCT03923556|Drug|Sugammadex|Administration of Sugammadex intravenously at a dose appropriate for the reversal of neuromuscular blockade (usually 0.03-0.07 mg/kg) at the end of the surgery before tracheal extubation
15864818|NCT03923556|Drug|Neostigmine|Administration of Neostigmine intravenously at a dose appropriate for the reversal of neuromuscular blockade (usually 2-4 mg/kg) at the end of the surgery before tracheal extubation
15864819|NCT03923543|Diagnostic Test|Neutrophil to lymphosit ratio|
15864820|NCT03923530|Drug|Eplerenone|Eplerenone 50 mg daily
15864821|NCT03923517|Device|RHAPSODY online program and MEET online sessions|"internet-based information and skill-building program (RHAPSODY) specifically developed for family carers of care recipients with young onset dementia (Kurz, et al., 2016).
~MEET is a software for online meetings."
15864822|NCT03923504|Other|Physical Activity Intervention (PAI)|Those who opt-in to attend in-person study visits and to undergo COVID testing will also complete an MRI exam and CPET testing. Participants unwilling to have COVID testing done will only complete an MRI exam and home-based testing. All testing will take place either within 6 weeks of initiating systemic treatments or within 8 weeks of completing radiation then at 3 & 6 months. Patients may participate in 1-2 training sessions per week offered under the direct supervision of a master's level clinical exercise physiologist, as well as 1-2 sessions at home. PAI sessions consist of slow aerobic warm-up, followed by 20 minutes of strength training,15 minutes of progressive intensity aerobic exercise (AE), and then 10 minutes of stretching for cool-down. Participants will have the ability to participate in training sessions facilitated via online channels at home.
15864823|NCT03923504|Other|Healthy Living Control|Patients randomized to the control arm will either attend online sessions via secure video conferencing (e.g. Zoom) or telephone or to come to a centralized meeting location (if safety allows) to participate in organized health workshops. Session attendance will be required 2 times/month (over the 6 months). Make up sessions will be offered for those participants who have to miss a group session. Each session lasts 60 minutes and matches the number of visits made by the PAI group as much as possible.
15864824|NCT03923491|Behavioral|Healthy Feeding, Healthy Eating|Home Based Motivational Interviewing to Improve Diet Quality of Preschoolers
15864825|NCT03923491|Behavioral|Reading Readiness|Active Control that uses Motivational Interviewing to improve Reading Readiness of Preschool Children
15864826|NCT03923478|Drug|ABI-M201|Active Treatment
15864827|NCT03923478|Drug|Placebo|Control Treatment
15880383|NCT03802032|Drug|Lidocaine Gel|topical lidocaine gel
15864831|NCT03923452|Behavioral|Mindfulness-based Stress Reduction|"Mindfulness-based stress reduction is a manualized mindfulness training protocol that has been researched for over 20 years. The original protocol will be used, with the exception of the prescribed home practice duration (i.e. 30 mins of practice). Rather, the program will be modified to set up participants for success by providing them with instruction to build on their meditation practice, beginning with 8 minutes a day."
15864832|NCT03923439|Device|Multi-b diffusion sequence MRI|Patients will be explored with the multi-b diffusion sequence on a new 3T research magnet equipped with high gradient system.
15864833|NCT03923426|Other|Zavicefta Treatment|Non-interventional - Retrospective Chart Review
15864834|NCT03923413|Other|Blood samples|Blood samples for MP evaluation
15864835|NCT03923387|Device|MynxGrip|Vascular Closure
15864836|NCT03923387|Other|Manual compression|Manual compression is a commonly used method to achieve hemostasis of femoral artery
15864837|NCT03923374|Drug|Subutex / Buprenorphine|Pregnant Mothers must be taking buprenorphine / subutex for opioid use disorder.
15864838|NCT03923374|Diagnostic Test|Fetal & Neonatal MRI|Mothers who consent will be given a fetal MRI and after the baby is born, a neonatal MRI.
15864839|NCT03923374|Diagnostic Test|DNA/Genetic/Pharmacokenetic Blood Draws|Throughout the pregnancy, Mothers will be participating in blood collection throughout the study. At enrollment, we will collect DNA, Genetic and PK blood specimens, then throughout the study, we will be collecting random PK samples.
15864840|NCT03923361|Drug|Diprivan|Similar to the high-intensity propofol treatments in Phase 1, the anesthesiologist will administer an induction dose of propofol followed by a continuous infusion, insert an airway, and begin mechanical ventilation. Propofol dosing will be adjusted with the goal of achieving a burst-suppression state with a SR of 40-60 for 12-15 minutes.
15864841|NCT03923348|Device|Leva device|The leva® Pelvic Digital Health System by Renovia Inc is a novel tool for subjects with urinary incontinence to train and strengthen pelvic floor muscles via directional mechano-transductive feedback on performance in the privacy of their own homes.
15864842|NCT03923335|Other|DNA methylation detection|detecting the methylation status of colorectal cancer specimen
15864843|NCT03923322|Drug|Botanical Tincture|Study participants will meet with the Investigator at baseline and week 2, 6, and 10 after the study period begins. Trial continuation criteria at 2 weeks after the start of the study includes abdominal pain intensity and stool frequency. Participants randomized to Botanical Tincture will have a 2-week withdrawal period. On the visits study participants may expect to be asked about epidemiologic information, IBS medications, IBS Quality of Life survey instruments, and daily diary of pain scale, bloating scale, and number of bowel movements.
15864844|NCT03923322|Other|Placebo|Study participants will meet with the Investigator at baseline and week 2, 6, and 10 after the study period begins. Trial continuation criteria at 2 weeks after the start of the study includes abdominal pain intensity and stool frequency. On the visits study participants may expect to be asked about epidemiologic information, IBS medications, IBS Quality of Life survey instruments, and daily diary of pain scale, bloating scale, and number of bowel movements.
15864845|NCT03923296|Device|Blood measurement and monitoring|Blood from a single fingerprick will be used to used to measure and monitor patients blood parameters
15864846|NCT03923270|Drug|Durvalumab|Participants in all arms will be administered 1500 mg of Durvalumab intravenously every 4 weeks.
15864847|NCT03923270|Drug|Tremelimumab|Participants in arm B will be administered 75 mg of Tremelimumab intravenously every 4 weeks for up to 4 doses.
15864848|NCT03923270|Drug|Olaparib Pill|Participants in arm C will be self-administer 300 mg of Olaparib orally.
15864849|NCT03923270|Radiation|Thoracic Radiotherapy|Thoracic Radiotherapy will be administered at 3 Gray units X 10 fractions
15864850|NCT03923270|Drug|Tremelimumab|Participants in arm D will be administered 300 mg of Tremelimumab intravenously in 1 single dose
15864851|NCT03923257|Drug|177Lu-DOTA-tyr3-OCTREOTATE|This is a peptide receptor radiotherapy that targets somatostatin receptors on tumor cells.
15864852|NCT03923257|Procedure|Peptide Receptor Radiotherapy (PRRT)|PRRT is internal radiation that is individually dosed according to patient body surface area, kidney function and bone marrow status.
15864853|NCT03923244|Diagnostic Test|OSDI survey|"Normal patient consultation schedule for cataract surgery with:
~Preoperative appointment scheduled for the patient
~Post-operative appointment 1 month before surgery No additional appointments.
~After geting consent and during the two consultations:
~Completion of a quality of life survey by the patient. Collection of the patient's history and general and ophthalmological treatments. Questionnaire of 12 items on quality of life to be completed. For each question, the patient must answer on the frequency of the discomfort felt, from never to all the time.
~An analysis of the ocular surface is performed by a non-invasive and non-contact device for 4 minutes. This consists of taking different photographs of the eye and eyelids, allowing each to study a part of the tears.
~Schirmer test is performed, consisting of applying the end of a small strip of blotting paper behind the lower eyelid and examining the strip after 5 minutes."
15864854|NCT03923231|Drug|Atazanavir 300mg/ Ritonavir 100 mg once daily|There is no intervention in this study - participants will all be receiving atazanavir (usually boosted with ritonavir) as part of their routine clinical care
15864855|NCT03923231|Drug|Atazanavir 250 mg / ritonavir 80 mg|There is no intervention in this study - participants will all be receiving atazanavir (usually boosted with ritonavir) as part of their routine clinical care. This dose of 250/ 80 is for participants weighing between 15 and 25 Kg
15864856|NCT03923218|Other|LL-37 levels in Gingival crevicular fluid|Collected gingival crevicular fluid
15864857|NCT03923218|Other|Serum Vitamin D3 levels|Collected serum
15864858|NCT03923218|Other|Clinical parameters|Recorded plague index, gingival index, probing depth, clinical attachment level
15864859|NCT03923205|Other|Dietary Intervention|The effect of a buckwheat beverage on postprandial glucose metabolism in healthy individuals and those with T2D controlled by medication and diet will be studied.
15864860|NCT03923192|Device|Vistacam|device for early proximal caries detection
15864861|NCT03923192|Radiation|Bitewing radiograph|radiograph for proximal caries detection
15864862|NCT03923179|Drug|Pyrotinib|Pyrotinib, 400mg qd
15864863|NCT03923179|Drug|Etoposide|Etoposide, 50mg，qd,d1-21,Q4W
15864864|NCT03923166|Drug|Pyrotinib|400mg qd
15864865|NCT03923166|Drug|capecitabine|capecitabine 500mg tid
15864866|NCT03923153|Device|Inspiratory muscle training with PowerBreathe (IMT Technologies Ltd., Birmingham,England)|"Treatment group II will receive inspiratory muscle endurance training (IMT) using threshold loading device (POWERbreathe Classic, IMT Technologies Ltd. Birmingham, England) at 30% of maximal inspiratory pressure (MIP).
~The MIP will be measured at supervised session each week, and 30% of measured MIP value will be the new training workload.
~The treatment group will train for 30 min-per/day, 7 days/week, for 8 weeks. Six sessions at home and 1 session will be performed at department."
15864867|NCT03923153|Device|Sham group with PowerBreathe (IMT Technologies Ltd., Birmingham, England)|"Treatment group II will receive inspiratory muscle endurance training (IMT) using threshold loading device (POWERbreathe Classic, IMT Technologies Ltd. Birmingham, England) at 10% of maximal inspiratory pressure (MIP).
~The MIP will be measured at supervised session each week, and 30% of measured MIP value will be the new training workload.
~The treatment group will train for 30 min-per/day, 7 days/week, for 8 weeks. Six sessions at home and 1 session will be performed at department."
15864868|NCT03923140|Drug|Tranilast|5mg/kg.d for juvenile patients with a maximum dose of 0.3g per day; 0.1g each time, three times a day for adults patients
15864869|NCT03923127|Other|Elan and HealthDot|Patients with elective surgery will wear two devices (HealthDot and Elan) after surgery in hospital and after discharge at home for up to 2 weeks (HealthDot) or 3 weeks (Elan).
15864870|NCT03923114|Radiation|Ga-68-NODAGA-exendin-4 PET/CT|PET/CT imaging after injection with Ga-68-NODAGA-exendin-4
15864871|NCT03923101|Diagnostic Test|Topographic, tomographic and biomechanical analysis.|"The study is based upon data obtained during routine medical follow-ups using
~the Pentacam high resolution (Oculus, Wetzlar, Germany)
~the Corvis ST (Oculus, Wetzlar, Germany)
~the Anterior-Segment Optical Coherence Tomograph (AS-OCT) Casia 2 (Tomey, Nagoya, Japan)
~the Ocular Response Analyzer (Reichert Technologies, New York, USA)."
15864872|NCT03923088|Behavioral|jacobson's progressive muscle relaxation technique|This involves tensing specific muscle groups for 5-7 seconds, followed by 20 seconds of relaxation. The method can be demonstrated chairside, and should be practiced and rehearsed by the patient at home. Four major muscle groups are commonly tensed and relaxed. These are: 1) feet, calves, thighs, and buttocks; 2) hands, forearms, and biceps; 3) chest, stomach, and lower back; and 4) head, face, throat, and shoulders
15864873|NCT03923088|Behavioral|audio-visual distraction technique|audiovisual distraction not only leads to full involvement of scenes (visual and auditory), but it also induces a positive emotional reaction resulting in a relaxed experience.
15864874|NCT03923075|Drug|Dexmedetomidine|INFUSION BEFORE INDUCTION OF ANAESTHESIA
15864875|NCT03923075|Other|0.9% saline|INFUSION BEFORE INDUCTION OF ANAESTHESIA
15864876|NCT03923062|Device|chemicalpeeling|"Cleansing and degreasing the face with alcohol .
~The patients must be sitting at an angle of 45.
~A 2 × 2 cm cotton gauze will be used to apply TCA 20%.
~We will apply the acid from the midline to the right side of the forehead and under the right eye, covering the right cheek and perioral area.
~We then will wait for a few minutes and will observe the frost developing.
~The patient will be then allowed to wash her face."
15864877|NCT03923062|Device|cryopeeling|Cryopeeling will be performed by spraying the freezing substance(Liquid Nitrogen) on the face at 1-2cm distance and moving along the affected area until freezing appear.
15864878|NCT03923062|Combination Product|microneedling|"Tranexamic acid will be used in aconcentration of 4mg/ml ,1ml will be used fo half of the face.
~After gentle cleansing, topical analgesic cream will be applied over the area to be treated.
~The microneedles will be used, the skin will be stretched and microneedling will be carried out in vertical, horizontal, and both diagonal directions for about four to five times. Tranexamic acid, 0.5 to 1 ml (4 mg/mL), will be applied over this area, and the procedure will be repeated four to five times in the above-said directions"
15864879|NCT03923049|Diagnostic Test|hybrid PET/MRI|On the day of the procedure, subjects will undergo a PET scan followed by MRI scan.
15864880|NCT03923036|Drug|Antineoplastic Agents|Exposure measurement to any anticancer drug in its therapeutic use for the metastatic colorectal cancer with its posology and duration (the list provided is non-limitative). Exposure to anticancer drugs for another indication than the colorectal cancer will also be collected.
15864881|NCT03923010|Drug|Itraconazole|Participants will receive itraconazole 200 mg orally once daily for 7 days and at the discretion of the treating physician on Day 14. Participants will also get their regular clinical care at the discretion of their treating physician.
15864882|NCT03922997|Drug|Atezolizumab|Atezolizumab will be administered at a fixed dose of 1200 mg intravenously on the first day of each 21-day cycle.
15864883|NCT03922984|Procedure|MRI with Arterial Spin Labeling (ASL)|Week 0 (Before initiation of chemoradiation): MRI with ASL will be performed along with patient's standard of care imaging session Week 3: contrast-enhanced research MRI with ASL Week 6: contrast-enhanced research MRI with ASL Week 10: MRI with ASL will be performed along with patient's standard of care imaging session Week 18: MRI with ASL will be performed along with patient's standard of care imaging session Week 26: MRI with ASL will be performed along with patient's standard of care imaging session Week 34: MRI with ASL will be performed along with patient's standard of care imaging session
15864884|NCT03922971|Other|Option 1: National comparison|Ability to view center's rate compared with all others.
15864885|NCT03922971|Other|Option 2: National comparison with benchmarking|Ability to view center's rate compared with the others with a similar patient comorbidity profile and in addition to viewing option 1.
15864886|NCT03922945|Drug|VI-0521 oral capsule|Phentermine/Topiramate
15864887|NCT03922945|Drug|Placebo oral capsule|Inactive drug
15864888|NCT03922919|Drug|Cefotaxime Injection|Systematic use of cefotaxime.
15864889|NCT03922919|Procedure|Rectal swab|Rectal swab every 3 days during hospitalization and then 30 days after the first antibiotic infusion
15864890|NCT03922919|Drug|Cefotaxime/ceftriaxone|ceftriaxone or cefotaxime infusion at the discretion of the prescribing physician
15864891|NCT03922906|Device|Pure-Vu System|Pure-Vu System is intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating and/or cleaning the colon and evacuating the irrigation fluid (saline water), feces and other bodily fluids and matter, e.g. blood.
15864892|NCT03922893|Other|Family History Information|The family history ascertainment focuses on self-reported family history of first-, second-, and third-degree family members, including types of malignancies/ pre-malignant lesions and age at diagnosis.
15864977|NCT03922282|Procedure|Classic BABA|BABA robotic-thyroidectomy that is using carbon dioxide.
15864893|NCT03922893|Genetic|ORAGENE|Approximately 2-4mL of saliva may be collected in specialized Oragene DNA Self-Collection Kit tubes or buccal swab-based collection devices.
15864894|NCT03922893|Genetic|Blood|For select participants, 1-2 tubes of blood will be drawn for DNA and RNA analysis
15864895|NCT03922893|Other|Skin Biopsy|In certain circumstances, for Memorial Sloan Kettering participants and their family members, it may be necessary to obtain a skin biopsy.
15864896|NCT03922880|Drug|ADI PEG20|ADI-PEG 20 will be administered at a dose of 36mg/m2 intramuscularly once a week.
15864897|NCT03922880|Drug|Nivolumab|Nivolumab 240mg + Ipilimumab 1mg/kg for up to 8 total doses of ipilimumab. One ipilimumab has completed, nivolumab 480mg will be given every 4 weeks.
15864898|NCT03922880|Drug|Ipilimumab|Ipilimumab 1mg/kg with Nivolumab 240mg for up to 8 total doses of ipilimumab. The first four doses of ipilimumab will be scheduled once every 3 weeks. The 5th-8th doses of ipilimumab will be scheduled once every 6 weeks with nivoumab 240mg every 3 weeks.
15864899|NCT03922867|Behavioral|CBT|A web-based educational platform to deliver cognitive behavioral therapy (CBT) for insomnia
15864900|NCT03922854|Other|Non-interventional data collection only|There is no clinical intervention. This study is just capturing data from devices used part of routine clinical care. The results of this data collection will be analysed to inform study results.
15864901|NCT03922841|Other|Pleural disease management|History, physical examination, pleural drainage, lab/radiographic investigations
15864902|NCT03922828|Diagnostic Test|CT scans|CT surveillance, Lung biopsy, Lung resection
15864903|NCT03922815|Drug|rescue fentanyl|a rescue dose of fentanyl 0,5 mcg per kilogram of body
15864904|NCT03922815|Drug|rescue propofol|propofol in a single dose of 0,5 mg/kg of body weight
15864905|NCT03922802|Device|Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training|Subjects will receive up to 45 minutes of AIH prior to receiving transcutaneous electrical spinal cord stimulation delivered by a Transcutaneous Spinal Cord Neurostimulator while performing locomotor activities.
15864906|NCT03922802|Other|Sham Acute Intermittent Hypoxia + Non Invasive Spinal Cord Stimulation + Gait Training|Subjects will perform locomotor activities with transcutaneous electrical spinal cord stimulation after receiving sham acute intermittent hypoxia
15864907|NCT03922802|Other|Sham Acute Intermittent Hypoxia + Sham Non Invasive Spinal Cord Stimulation + Gait Training|Subjects will perform locomotor activities with sham transcutaneous electrical spinal cord stimulation after receiving sham acute intermittent hypoxia
15864908|NCT03922789|Diagnostic Test|6 minute walking test|change of 6MWT pre to post pulmonary rehabilitation
15864909|NCT03922776|Procedure|Blood sample collection|"Participants will receive the following interventions because they are enrolled in the study: blood sample collection
~at diagnosis, before chemotherapy (pre-CT)
~after chemotherapy (post-ct) Collection of two blood samples (5mL),
~before chemotherapy (pre-CT), at diagnosis, up to 1 month after enrollment
~and then, after chemotherapy (post-CT), up to 3 months after enrollment"
15864910|NCT03922763|Procedure|Anatomical cut|Surgeon-derived cut based on patient's anatomy
15864911|NCT03922763|Procedure|Cutting guide|Angle cut at 132.5 degrees based on cutting guide
15864912|NCT03922750|Drug|Insulin icodec|Participants will receive subcutaneous (s.c.) injections of Insulin 287 OW for 16 weeks.
15864913|NCT03922750|Drug|Insulin glargine U100|Participants will receive s.c. injections of insulin glargine OD for 16 weeks
15864914|NCT03922737|Procedure|In-person office visit|Post-operative visit to occur in-person with provider
15864915|NCT03922737|Procedure|Teleheath visit|Post-operative visit to occur via telehealth software platform with provider
15864922|NCT03922711|Drug|Pridopidine|Oral capsule
15864923|NCT03922711|Drug|Placebo|Oral capsule
15864924|NCT03922698|Other|No interventions|No interventions - observational study
15864925|NCT03922685|Combination Product|Dietary manipulation (25% carbohydrate diet) and behavioral (exercise)|The 25% carbohydrate diet consisted of Pulmocare-vanilla liquid, white roll, butter, and string cheese in proportions to achieve 33% of weigh-maintenance diet containing 25% carbohydrate, 20% protein, and 55% fat. Exercise was walking 1 hour on level treadmill at 50% of maximal effort starting 40 minutes after the beginning of the meal
15864926|NCT03922685|Combination Product|Dietary manipulation (25% carbohydrate diet) and behavioral (sedentary)|The 25% carbohydrate diet consisted of Pulmocare-vanilla liquid, white roll, butter, and string cheese in proportions to achieve 33% of weigh-maintenance diet containing 25% carbohydrate, 20% protein, and 55% fat. There was no exercise during this trial.
15864927|NCT03922672|Behavioral|Group piano training|The group piano training is scheduled over 4 months of a two-hour weekly group piano lesson. There is also a 3-hour weekly practice at home.
15864928|NCT03922659|Combination Product|Transcranial magnetic stimulation and Cognitive behavioral therapy|Transcranial magnetic stimulation on different side with/without cognitive behavioral therapy
15865014|NCT03921931|Other|White light stimulation|Stimulation of the retina with white light
15865015|NCT03921918|Device|Breast Pump|Hydraulic Breast pump
15864929|NCT03922646|Behavioral|Neurocognitive Empowerment for Addiction Treatment (NEAT)|NEAT will be conducted in person, in groups of 6-14, and consist of 14, 1.5-hour sessions. Each NEAT session will consist of (1) a didactic, psychoeducation portion describing the concepts and skills of focus, (2) written material with descriptions of the concepts/skills in verbal and pictorial (cartoon) formats, (3) practicing with cognitive tasks relevant for each skill, (4) discussion of how they can monitor and practice each skill in their daily life. Specifically, we will provide psychoeducation, cognitive exercises, time-management and daily practice focused on domains of attention (focused and divided attention; attentional biases), memory (declarative, prospective, emotional memory), flexibility and inhibition, and problem-solving. Each session will discuss the relevance of these functions for the recovery from drug addiction and for managing affective/motivational symptoms commonly related to substance use (i.e., craving, anxiety, depression, trauma).
15864930|NCT03922646|Behavioral|Active Control|The active control intervention will be composed of active, but non-essential aspects of the larger treatment program (i.e., those that treatment programs do not believe are necessary or central to their program, for example, art classes, exercise classes, chore time, or extra 12 steps meetings). This will ensure that subjects are not being prevented from accessing treatment that is already known to be helpful in substance use recovery, that the active control condition and NEAT intervention have equivalent credibility and expectancies, and optimizing the generalizability of findings.
15864931|NCT03922633|Drug|E3112|Intravenous infusion.
15864932|NCT03922633|Other|Placebo|Intravenous infusion.
15864935|NCT03922607|Drug|ABBV-157|ABBV-157 will be administered orally as capsule
15864936|NCT03922607|Drug|Placebo for ABBV-157|Placebo for ABBV-157 will be administered orally as capsule
15864937|NCT03922594|Diagnostic Test|Differential diagnosis for infectious causes of microcephaly|Zika virus, cytomegalovirus, rubella, toxoplasmosis
15864938|NCT03922581|Behavioral|Mindfulness-Based Cognitive Therapy|The intervention consists of MBCT for the prevention of depression relapse with adaptations for discussing trauma and PTSD. Participants attend eight, weekly 90-minute group sessions involving skills training and in-class practice. Participants will return one month after the intervention has ended for a follow-up assessment.
15864939|NCT03922568|Other|Density Gradient Centrifugation|semen was layered over 50 % and 90% discontinuous Density Gradient layers in a 15ml conical tube, then centrifuged at 250 g for 8 min at room temperature. supernatant was aspirated and the resulted pellet was washed using Sperm wash media and centrifuged at 250 g for 8 min at room temperature. The final pellet was re suspended in residual volume
15864940|NCT03922568|Device|Physiological ICSI|Semen processing is done by double layer density gradient method followed by adding Sperm to the dot of hyaluronan on the PICSI dish, within minutes the bound sperm are attached by their acrosome to the surface of the dot. Hyaluronan bound sperms are selected for oocyte injection
15864941|NCT03922568|Device|Magnetic Activated Cell Sorting|Semen processing is done by double layer density gradient method. The resulted pellet is labeled with Annexin V microbeads followed by separation on MACS column, the eluted fraction contains non apoptotic sperms suitable for oocyte injection.
15864942|NCT03922555|Drug|ASTX727|ASTX727 is made up of the 2 study drugs cedazuridine and decitabine. Cedazuridine is believed to work by slowing down how fast decitabine is broken down by the body. Decitabine is believed to work by blocking abnormal cells or cancer cells from growing.
15864943|NCT03922542|Combination Product|riboflavin 0.1%|Use of riboflavin 0.1% eye drops and 9 mW/cm2 UVA light for 10 minutes
15864944|NCT03922542|Combination Product|Riboflavin 0.1%|Use of riboflavin 0.1% eye drops and 3 mW/cm2 UVA light for 30 minutes
15864945|NCT03922529|Behavioral|MACRO|Modified application of cardiac rehabilitation for older adults (MACRO) intervention transforms Cardiac Rehabilitation by organizing relative to participants' goals of care and composite risks rather than central emphasis on cardiovascular disease (CVD). Participants are engaged, assessed for their goals of care as well as their risks, and education is initiated to best facilitate informed choices regarding realistic and practical strategies.
15864946|NCT03922529|Other|Standard of Care|Participants will follow the standard of care hospital practice that is recommended for the participant. The study will follow the participant for the course of the study to see the comparison to the MACRO arm
15864947|NCT03922516|Diagnostic Test|ULDCT|Ultra-Low-Dose-CT (ULDCT) of the chest using tin filters with third-generation dual-energy CT devices. The projected dose used will be approximately 0.2 mSv per ULDCT of the chest.
15864948|NCT03922503|Procedure|Advanced- platelets rich fibrin (A-PRF) with Demineralized freeze-dried bone allograft (DFDBA)|In A-PRF assigned group, one PRF will be cut into small pieces and added to the Demineralized freeze-dried bone allograft (DFDBA) in a ratio of 1:1 and the mixture is applied into the intraosseous defect, and the other will be used to prepare the membrane to cover the defect as a barrier.The mucoperiosteal flaps will be repositioned and secured in place using4-0 silk sutures.
15864949|NCT03922503|Procedure|Collagen membrane with Demineralized freeze-dried bone allograft (DFDBA)|After debridement and intraoperative recordings, in the control group, Demineralized freeze-dried bone allograft (DFDBA) will be applied to the bone defect without overfilling and is protected by a collagen membrane, then interrupted sutures using 4-0 silk sutures will be placed to reposition the flaps.
15864950|NCT03922490|Device|Lipogems Device PLUS debridement|Lipogems is the name of the technology used to obtain stem cells from the abdomen, which will then be injected into the knee after knee arthroscopy.
15864951|NCT03922490|Procedure|Debridement only|Patients will undergo knee arthroscopy as a standard treatment for their condition but will not receive the fat-derived stem cell treatment nor will undergo any additional procedures.
15864952|NCT03922477|Drug|Atezolizumab|Atezolizumab will be administered to participants by IV infusion at a fixed dose starting on Day 22 of Cycle 1. In subsequent cycles (Cycles 2 and beyond), IV atezolizumab will be given every 2 weeks (Q2W) on Days 8 and 22 of each 28-day cycle.
15865016|NCT03921905|Diagnostic Test|ABI measurement|ABI measurement wil be done with an automatic device to diagnose PAD in patients with CAD
15865367|NCT03919032|Other|This is an observational study without intervention|This is an observational study without intervention
15864953|NCT03922477|Drug|Hu5F9-G4|Two priming doses of 1 mg/kg of Hu5F9-G4 will be administered to participants by continuous IV infusion on Days 1 and 4 of Cycle 1, followed by loading doses of 15 mg/kg IV on Day 8 and 30 mg/kg IV on Day 11. Starting on Day 15 of Cycle 1, Hu5F9-G4 maintenance will be given by IV infusion at a dose of 30 mg/kg once a week (QW) of each 28-day cycle. Dosing for de-escalation, if needed: Hu5F9-G4 will be given as two priming doses of 1 mg/kg IV on Days 1 and 4, followed by loading doses of 10 mg/kg IV on Day 8 and 15 mg/kg on Day 11. Starting on Day 15, maintenance treatment with Hu5F9-G4 will be given by IV infusion at a dose of 15 mg/kg once a week (QW).
15864954|NCT03922464|Device|Poly-L-lactic acid (Sculptra® Aesthetic)|"Sculptra® Aesthetic is a commercially available product that is licensed for sale in Canada. It is an injectable implant that contains microparticles of poly-L-lactic acid (PLLA), a biocompatible, biodegradable, synthetic polymer from the alpha-hydroxy-acid family. Sculptra® Aesthetic is suitable for increasing the volume of depressed areas, particularly to correct skin depressions, such as in skin creases, wrinkles, folds, scars and for skin aging. Sculptra® Aesthetic is also suitable for large volume corrections of the signs of facial fat loss (lipoatrophy).
~The safety and efficacy of Sculptra® Aesthetic has been investigated in the literature and is generally considered safe and effective. PLLA has been used successfully to reverse HIV-associated lipoatrophy as well as to rejuvenate the face, neck, décolletage, hands, abdomen and gluteal regions."
15864955|NCT03922451|Drug|piperacillin-tazobactam|Administered for infection treatment or prophylaxis per hospital protocol
15864956|NCT03922451|Drug|Cefazolin|Administered for infection treatment or prophylaxis per hospital protocol
15864957|NCT03922438|Procedure|usage of cleft margin flap with anterior palatal closure during primary cleft lip repair.|Under general anesthesia, preparation of lip and palatal flaps will be done and then cleft margin flap which is designed to be inferiorly based will be used with anterior palatal closure in an attempt to decrease the incidence rate of naso-alveolar fistula (defect) that is usually occur and remain in those patients post-operatively.
15864958|NCT03922425|Other|Community mental health team|CMHT will provide home-based treatment inclusive of crisis resolution services and procedures for early recognition of subclinical psychosis and bipolar disorder, and intensive case management. Integrated care (i.e. health and social care interventions) will be provided to all clients. Furthermore, health and social care evidence-based interventions for severe mental illness (SMI) will be employed during home treatment, such as family-based interventions, motivational interviewing, and cognitive behavioural therapies, combined with medication management and identifying employment (paid and non paid options) and support in finding and maintaining this employment, recovery groups and housing opportunities.
15864959|NCT03922412|Procedure|PLANTAR BLOCK|"Sciatic popliteal block : patient in lateral position, injection of 20 ml of the mixture labelled  BLOC POPLITE  containing 20 ml of mepivacain 1% (200mg)
~Plantar block 10 minutes later : patient in supine position. Medial midfoot injection of 5 ml of the mixture labelled  BLOC PLANTAIRE  containing 5 ml of Ropivacaine 0,5% (25mg) with 0,5 ml dexaméthasone (2mg)
~Distal deep fibular block : patient in supine position, injection around the dorsal foot artery of 2 ml of the mixture labelled  BLOC FIBULAIRE  containing 2 ml of Ropivacaine 0,5% (10mg)."
15864960|NCT03922412|Procedure|Sciatic popliteal block|"1-Sciatic popliteal block : patient in lateral position, injection of 20 ml of the mixture labelled  BLOC POPLITE  containing 20 ml of ropivacaine 0,5% (100mg) with 2mg (0,5 ml) of dexamethasone"
15864961|NCT03922399|Procedure|Laser and Surgery|Laser and Surgery in patients with major burn scars Evaluating after three years treatment
15864962|NCT03922386|Device|XFINE leads|Pacemaker subjects with at least one XFINE passive lead
15864963|NCT03922373|Drug|Group A: Benzonatate 100mg|Subjects in group A will be given benzonatate 100mg once after a 10-hour fast in the first day of the trail
15864964|NCT03922373|Drug|Group B: Benzonatate 200mg|Subjects in group B will be given benzonatate 200mg once after a 10-hour fast in the first day of the trail, and they will be given benzonatate 200mg thrice in the second and third day of the trail, in the fourth day, they will be given benzonatate 200mg once after a 10-hour fast.
15864965|NCT03922373|Drug|Group C: Benzonatate 400mg|Subjects in group C will be given benzonatate 400mg once after a 10-hour fast in the first day of the trail
15864966|NCT03922360|Behavioral|Smartphone-based Financial Incentives|"Best Practices- The 2008 Clinical Practice Guidelines for smoking cessation recommends that pregnant smokers be provided with the 5As. Research staff will implement the 5As at three assessments that take place during pregnancy.
~Best Practices + Financial Incentive- Women assigned to this condition will receive the best practices treatment described above plus the remote incentives intervention.
~Beginning on the quit date and extending for one week, participants will be required to submit twice daily CO samples. All samples < 6 ppm will be considered negative and those > 6 ppm will be considered positive. Participants will earn incentives for breath tests indicating smoking abstinence, and incentive values will increase with each consecutive negative sample. Following the initial quit week, the schedule of monitoring will be reduced and incentives will be contingent on submitting a negative saliva cotinine test."
15864967|NCT03922360|Behavioral|Best Practices|Best Practices- The 2008 Clinical Practice Guidelines for smoking cessation recommends that pregnant smokers be provided with the 5As. Research staff will implement the 5As at three assessments that take place during pregnancy.
15864968|NCT03922347|Diagnostic Test|Screening program including 2 consecutive tests|visual acuity test by Snellen chart, fundus imaging by fundus photography (Visucam Pro NM; Carl Zeiss Meditec AG, Germany)
15864969|NCT03922347|Diagnostic Test|Screening program with mobile health|Peek Acuity and Peek Retina installed on smart phones (Samsung Galaxy S8)
15864970|NCT03922334|Behavioral|Patient Navigation Program|A postpartum patient navigation program is designed to reduce barriers to care, enhance access, and improve multiple postpartum health outcomes, including retention in care, contraception uptake, vaccination, and depression screening.
15864971|NCT03922321|Drug|RVT-1401 (Administered via subcutaneous injection)|RVT-1401 is a fully human anti-neonatal Fc receptor (FcRn) monoclonal antibody.
15864975|NCT03922295|Procedure|Endoscopic tympanoplasty|"In the double flap group, graft is placed via elevation of both posterior and anterior flaps.
~In the single flap group, graft is placed via elevation of posterior flap only"
15864978|NCT03922256|Other|molded brace|The moldable brace utilized in the current study will be pre-fabricated and of the short-arm brace variety , which is primarily indicated for non-displaced fractures of the distal radius or distal ulna. The braces are available in multiple sizes for both right and left hands.
15864979|NCT03922243|Other|retrospective|Retrospective study to assess treatment done by dental students
15864980|NCT03922217|Device|Mindful My Way|Mindful My Way (MMW) is a mobile application created for iOS, designed to delivered a form of mindfulness-based therapy to depressed older adults
15864981|NCT03922204|Drug|MCLA-145|full-length IgG1 bispecific antibody specifically targeting PD-L1 and CD137
15864982|NCT03922191|Other|Data extraction from medical files|Data extraction from medical files
15864983|NCT03922178|Device|Pressure/Volume Combination Catheter|Hemodynamic data routinely collected and data collected by means of the placement of a Pressure/Volume Combination Catheter (Pressure/Volume Combination Catheter,Leycom,The Netherlands) will be collected simultaneously. The catheter will be placed and held in place as long as the patient is in a position to be assisted by extracorporeal circulation. This means that the placement of the catheter will follow the heparinization of the patient and the placement of the cannulas necessary for the realization of extracorporal circulation. It will be removed from the left ventricular cavity before removal of extra-corporal cannulas.
15864984|NCT03922178|Device|Transthoracic echocardiography|A complete transthoracic echocardiography will be performed the day before the surgical procedure, as per standard of care. It will establish the presence of the inclusion and exclusion criteria and evaluate the contractile function of the left ventricle. This will be done using a Philips IE33 echocardiograph (Koninklijke Philips Electronics N.V., Netherlands).
15864985|NCT03922178|Device|Transesophageal echocardiogram|A transesophageal echocardiogram will be performed during the cardiac surgery, as per standard of care, using an Acuson Sequoia system (Siemens AG, Germany). It will facilitate the placement of the pressure/volume combination catheter and collect echographic data.
15864986|NCT03922165|Procedure|Adenotonsillectomy|Routine AT per clinical care.
15864987|NCT03922152|Radiation|Short course radiotherapy|An accelerated hypo-fractionation 2D-radiotherapy is delivered for palliation in patients with advanced esophageal cancer.
15864988|NCT03922139|Drug|OnabotulinumtoxinA Injection|"Ultrasound guided 1 mg/1 mL injection.
~25 units of Botox will be injected 2 cm proximal and 2 cm distal to the midpoint of the tibialis anterior muscle."
15864989|NCT03922126|Other|Peer counseling|Information, motivation, and behavioral skills for HIV/STI testing and pre-exposure prophylaxis uptake
15864990|NCT03922126|Diagnostic Test|HIV/STI self-testing kits|Kits to self-test for HIV/STIs
15864991|NCT03922113|Other|Patient follow up|Patient follow up during one month
15864992|NCT03922100|Drug|NMS-03592088|NMS-03592088 will be administered orally once daily for 21 or 28 consecutive days of each treatment cycle. A treatment cycle will comprise 21 days of NMS-03592088 administration (Day 1 to 21) followed by 7 days of rest for a total of 28 days (4 weeks) period for Schedule A and 28 days of NMS-03592088 administration (Day 1 to 28) for a total of 28 days (4 weeks) period for Schedule B.
15864993|NCT03922087|Other|No intervention|No intervention
15864994|NCT03922074|Procedure|Sedation directed by an endoscopist|"The nurse begins with fentanyl infusion in bolus: 75 μg (1.5 ml) and initial propofol dose (10mg/ml) in bolus of 0.5 - 2.5 mg/Kg followed by a maintenance dose of 20 - 60ml/h through Target-controlled infusion (TCI) pump. In this way, we get a target level sedation between 1 - 3, according to Observer's Assessment of Alertness/Sedation Scale (OAAS).
~The role of the nurse, directed by an endoscopist, it is exclusively the administration of intravenous drugs and the patient monitorship throughout the procedure."
15864995|NCT03922074|Procedure|Sedation directed by an anesthesiologist|The choice of the drugs and the target level sedation are directed by an anesthesiologist
15864996|NCT03922061|Biological|dmLT|double mutant [LT(R192G/L211A)] Enterotoxigenic Escherichia coli heat labile toxin (dmLT)
15864997|NCT03922061|Biological|fIPV|fractional-dose inactived polio vaccine
15864998|NCT03922048|Drug|HTX-011|Single-dose instillation of approximately 0.17 mL/kg (total dose does not exceed 10.5 mL) of HTX-011.
15864999|NCT03922048|Device|Luer lock applicator|Applicator for instillation.
15865000|NCT03922048|Drug|Bupivacaine HCl|Bupivacaine HCl 0.25% (without epinephrine) 0.5 to 1.0 mL/kg (total dose not to exceed 75 mg).
15865001|NCT03922048|Drug|HTX-011|Dose to be determined from Cohort 1.
15865002|NCT03922048|Drug|HTX-011|Dose to be determined from Cohorts 1 and 2.
15865003|NCT03922048|Drug|HTX-011|Dose to be determined from Cohort 1 Part A.
15865004|NCT03922035|Other|Best Practice|Receive standard peri-/post-transplant supportive care
15865005|NCT03922035|Drug|Clostridium butyricum CBM 588 Probiotic Strain|Given PO
15865006|NCT03922022|Behavioral|EIM exercise classes and intervention|This is a complex intervention. On recruitment, they will be seen by a nurse and counselled using motivational technique. They will then undergo a 12-week class. The exercise levels will be regularly feedback to the patients by use of mobile devices and trackers. Peer support is formed during the 12-week class. Resources to continue exercise will be provided to patients. Regular monitoring of physical improvement will be feedback to patients to encourage continued exercise.
15865007|NCT03922009|Device|Virtual Reality|The primary objective of this study was to evaluate the use of VR to reduce anxiety in spinal anesthesia patients compared with controls
15865008|NCT03921996|Procedure|Radical prostatectomy (RP) followed by ePLND|ePLND is performed either before or after radical prostatectomy and includes the removal of all nodal and fibro-fatty tissue
15865009|NCT03921996|Procedure|Radical prostatectomy (RP) only|Radical prostatectomy
15865010|NCT03921983|Other|Oxygen supplementation|short term O2 supplementation during 1 hour
15865011|NCT03921970|Other|ESP block (Group ESP)|Patients will be administered paracetamol 1 gr IV every 8 hours in the postoperative period. The PCA device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 20 mcg bolus without infusion dose, 20 min lockout time and 4 hour limit.
15865012|NCT03921957|Radiation|stereotactic radiotherapy|first level : W1 : 3 fractions - W2 : 2 fractions - W3 : 3 fractions second level : W1 3 fractions - W2 : 3 fractions - W3 : 3 fractions Third level : W1 : 4 fractions - W2 : 2 fractions - W3 : 2 fractions Fourth level : W1 : 4 fractions - W2 : 4 fractions
15865013|NCT03921944|Diagnostic Test|CT scan of the shoulders|studies of both operative and nonoperative shoulders
15865017|NCT03921892|Behavioral|Parenting Education|Parenting education such as positive parenting interactions with their child, knowledge of developmental milestones and interactions with the child to support that development, as well as co-parenting skills will be provided either in-person or on-line to adolescent fathers
15865018|NCT03921879|Drug|OT-82 Dose Escalation|The starting OT-82 dose level will be16.5mg/m2 given orally as an oral suspension once daily on Days 1-3, 8-10, and 15-17 of each successive 28-day cycle. Dose escalation will follow a modified 3+3 design. There is no maximum duration of OT-82 treatment; however, treatment will be discontinued if there is unacceptable toxicity, disease progression, withdrawal of consent by the patient, noncompliance with study requirements, intercurrent illness, development of symptoms or conditions listed as exclusion criteria, or closure of the study by the Sponsor.
15865019|NCT03921879|Drug|OT-82 Dose Expansion|A total of 25 patients evaluable for disease response will be treated with OT-82 on Days 1-3, 8-10, and 15-17 of the 28-day cycle at the MTD or maximum tested dose determined from Stage 1. This may include patients treated at that dose in Stage 1 plus expansion at that dose during Stage 2. Evaluability for disease response requires that patients receive at least one dose of OT-82. There is no maximum duration of OT-82 treatment; however, treatment will be discontinued if there is unacceptable toxicity, disease progression, withdrawal of consent by the patient, noncompliance with study requirements, intercurrent illness, development of symptoms or conditions listed as exclusion criteria, or closure of the study by the Sponsor.
15865020|NCT03921866|Drug|Palbociclib|Palbociclib
15865021|NCT03921853|Other|Behavioral|The 20-week RT program will consist of three sessions per week, each lasting for 1 hour that will be applied to both control obese (CG) and morbid obese (MO) group. All sessions will start with 15 minutes warm-up with continuous walking and joint mobility and flexibility exercises, 5 minutes of cool down and stretching, in order for preventing injuries. Sessions will include 4 to 8 RT exercises targeting different muscle groups; 1. forearm, 2. knee flexors and 3. extensors, 3. trunk, 4. chest, 5. shoulder elevators, 6. horizontal shoulder flexors and 7. extensors, and 8. plantar flexors. The exercises for each muscle group will be performed in 3 sets of as many repetitions (continuous concentric/eccentric voluntary contraction) possible in 1 minute followed by 2.0 minutes of passive recovery. Before the RT program, each participant will be measure using the subjective modified Borg scale (1-10 points), in order of identifying the muscle failure into 1 minute of exercise.
15865022|NCT03921840|Behavioral|ELDERFITNESS|"In person training: Participants will receive a 2-hour in person education session with the exercise trainer. Self-monitoring: Subjects will self-monitor subjects' level of physical activity (steps & minutes of moderate activity) using the smartwatch. The Google calendar and Fitbit apps will send messages and alerts to the subject's smartwatch that encourage subjects to achieve subjects' daily goals. If a participant has low activity for 3 consecutive days, the research assistant will call the participant to either encourage the participant to adhere to the plan or provide a modified plan after consulting the exercise trainer.
~Phone consultation: Subjects will have biweekly phone consultation with the research team members to receive guidance and adjustment on activity plans. Financial incentives: The intervention will include financial incentives. Specifically, when the daily activity goal is achieved for more than four days per week, a $5 reward will be given to subjects."
15865023|NCT03921840|Other|Control|General education on physical activity for older adults and continue daily activity and healthcare routine. Participants will also receive a Go4Life program book from the National Institute on Aging.
15865024|NCT03921827|Device|Enhance External Counterpulsation Therapy|EECP therapy would be administered to this group for 1-hour a day for a total of 35 sessions
15865025|NCT03921814|Device|Treatment with IPL device|Exposure of body parts to the IPL device
15865026|NCT03921801|Behavioral|Strength training + biofeedback|Home based strength training intervention for plantarflexor muscles conducted three times per week for 14 weeks. In addition, gait retraining session using real-time electromyography biofeedback performed once per week.
15865027|NCT03921775|Drug|Remimazolam Tosilate|For induction and maintenance of general anesthesia
15865028|NCT03921775|Drug|Propofol|For induction and maintenance of general anesthesia
15865029|NCT03921762|Procedure|Cataract surgery with Artis Active IOLs|Patients will be implanted with the Artis Active IOLs during cataract surgery
15865030|NCT03921762|Procedure|Cataract surgery with AT Lara IOLs|Patients will be implanted with the AT Lara IOLs during cataract surgery
15865031|NCT03921749|Device|Shockwave|"Both shockwave interventions will be administered without local anaesthesia. Three sessions will be administered at one-week intervals. During each session, 2000 pulses (1000 shots at the patellofemoral and tibiofemoral borders of the target knee and 1000 shots on the subchondral bone of the medial tibia condyle of the affected knee) will be delivered at 5 Hz. Energy flux density was 0.20 mJ/mm2 for patients in the focused group while radial shock waves were transmitted with 0.17 mJ/mm2 corresponding to a 3-bar energy level setting."
15865032|NCT03921736|Drug|Perindopril|4 mg/day p.o. for 12 months
15865033|NCT03921736|Drug|Hydrochlorothiazide|hydrochlorothiazide 25 mg/day p.o. for 12 months
15865034|NCT03921736|Drug|Estracomb TTS|Transdermal patches releasing 17β-estradiol (0.05 mg/24 hours) and norethisterone (0.25 mg/24 hours) for 12 months
15865035|NCT03921723|Drug|Dolutegravir dispersible tablet|DTG will be available as an oral tablet with dosing strength of 5 mg 2 tablet will be dispersed in water will be administered orally for prescribed regimen.
15865036|NCT03921723|Drug|Dolutegravir oral suspension|DTG will be available as an oral suspension with dosing strength of 5 mg per milliliter (ml) or 2 mg per ml with miglyol 812N or ethyl cellulose in miglyol 812N as vehicle for suspension administered orally for prescribed regimen.
15865037|NCT03921723|Drug|Dolutegravir oral solution|DTG will be available as an oral solution with dosing strength of 2 mg per ml will be administered orally for prescribed regimen.
15865038|NCT03921710|Drug|CAPA-IVM|Immature oocytes were plated into a 4-well dish (Nunc, Denmark) at 10 COCs/well using CAPA medium (Medicult IVM medium; Origio, Denmark supplemented with 1 mIU/mL rFSH, 5 ng/mL insulin, 10 nM estradiol, 10 mg/mL human serum albumin [SAGE, Denmark] and 25 nM CNP under oil for 24 h at 37°C, 6% carbon dioxide in air). After 24 hours, COCs were washed and transferred into IVM medium (Origio, Denmark) containing 5 ng/mL insulin, 10 nM estradiol, 100 ng/mL human recombinant amphiregulin and 100 mIU/mL rFSH, and incubated under oil for 30 h at 37°C, 6% carbon dioxide in air.
15865128|NCT03921008|Radiation|Radiation therapy|-Patients may be treated with electrons, 3D conformal photon radiotherapy, intensity modulated photon radiotherapy (IMRT), proton radiation therapy, or a combination of these.
15865039|NCT03921710|Drug|Standard-IVM|Immature oocytes are plated into a 4-well dish at 10 COCs/well using IVM medium supplemented with 75 mIU/mL recombinant FSH (Merck, Switzerland), 100 mIU/mL hCG (MSD, USA), 0.01 mg/mL growth hormone (Merck, Switzerland) and 10 mg/mL human serum albumin (SAGE, Denmark). COCs were incubated for 30 hours at 37°C, 6% carbon dioxide in air.
15865040|NCT03921697|Device|Werable sensors|Parkinson Disease Patients monitored by werable sensors
15865041|NCT03921684|Drug|Capecitabine|Capecitabine 825 mg/m2 orally twice-daily, 5 days a week for a total of 28 days, given with radiation therapy
15865042|NCT03921684|Radiation|Radiation therapy|1.8 Gy/day, 5 days a week for a total of 28 days, given with Capecitabine
15865043|NCT03921684|Drug|mFOLFOX6|oxaliplatin 85 mg/m2, leucovorin 400 mg/m2 and fluorouracil 400 mg/m2 IV, fluorouracil 2400 mg/m2 IV (a 46 hrs CI), day 1 of each treatment cycle, every 2 weeks, given with nivolumab
15865044|NCT03921684|Drug|Nivolumab|Nivolumab 240mg IV, day 1 of each treatment cycle, every two weeks, given with mFOLFOX6
15865045|NCT03921671|Combination Product|Ramucirumab|Combination of ramucirumab (10 mg / kg) + carboplatin (AUC 5) and paclitaxel (200 mg / m2) in patients with carcinoma thymic (or thymoma B3 with areas of carcinoma), relapsed and / or metastatic, in the first line.
15865046|NCT03921645|Drug|aerosol antibiotics|use of inhaled Antibacterial drug combined with intravenous antibiotics to treatment multiple drug resistance GNB ventilator associated pneumonia.
15865047|NCT03921632|Behavioral|Smiles Matter Oral Health Education Series|Three sessions scheduled 2 weeks apart consisting of 15-20 minutes of didactic learning, 10 minutes of a group/personal exercise, and 10 minutes of questions that the patients have on the topic discussed that day
15865048|NCT03921619|Device|Shoulder Sling|soft shoulder sling that is placed around the forearm, with a strap draped over the shoulder
15865049|NCT03921606|Behavioral|Motivational Interviewing (i-BMI)|A brief MI via WhatsApp/WeChat
15865050|NCT03921606|Behavioral|Individual face-to-face generic health advice|Individual face-to-face generic health advice (about 5 minutes) on a health-related lifestyle practice such as eating more vegetables and fruits, eating less high salt, fat or sugar foods, consuming less sugary drinks, engaging in more exercise of any kind or intensity, reducing alcohol consumption or reducing weight (if overweight or obese). A self-help booklet on smoking cessation published by the Hong Kong Council on Smoking and Health with Hotline will be also provided in the SOPCs.
15865051|NCT03921593|Procedure|Solid Organ Pancreas Transplantation with or without Kidney Transplantation|Deceased donor pancreas transplantation
15865052|NCT03921580|Other|Control Canned Tuna|210 g/day
15865053|NCT03921580|Other|Enriched Canned Tuna Variety 1|210 g/day
15865054|NCT03921580|Other|Enriched Canned Tuna Variety 2|210 g/day
15865055|NCT03921567|Drug|Lidocaine Hydrochloride|at induction of anesthesia will be given lidocaine 2mg / kg / i.v., bolus, and in perioperative and postoperative period will be given lidocaine 1.5mg / kg / h-1, continuously during surgery and 48 hours after surgery.
15865056|NCT03921567|Drug|Lidocaine Hydrochloride and Ketamine|at induction of anesthesia will be given lidocaine 2mg / kg / i.v., bolus, and ketamine 0.15mg / kg / , bolus, i.v .; lidocaine will continue during the operation and in the postoperative period with a dose of 1.5mg / kg / h-1, continuously, during the operation and 48 hours after the operation
15865057|NCT03921567|Drug|Placebo|will be given opioids during surgery, and opioids and nonsteroid antiinflammatory agents will be given 48 hours after surgery.
15865058|NCT03921554|Drug|Baricitinib|Baricitinib will be taken by mouth or via gastrostomy feeding tube or nasogastric tube as directed by the study doctor. Baricitinib will be dosed by patient age, weight range and estimated glomerular filtration rate (eGFR). Dosing formulations in use in this study will include 1 mg and 2 mg tablets and will be used without splitting. Dispersion will be permitted to aid in swallowing.
15865059|NCT03921541|Drug|Pegzilarginase|Individualized disease management which includes severe protein restriction, essential amino acid supplementation and the ammonia scavengers when indicated
15865060|NCT03921541|Drug|Placebo|Individualized disease management which includes severe protein restriction, essential amino acid supplementation and the ammonia scavengers when indicated
15865061|NCT03921541|Drug|Pegzilarginase|Individualized disease management which includes severe protein restriction, essential amino acid supplementation and the ammonia scavengers when indicated
15865062|NCT03921528|Biological|SRK-015|SRK-015 is a fully human anti-proMyostatin monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/lambda isotype that binds to human pro/latent myostatin with high affinity. SRK-015 will be administered every 4 weeks by intravenous infusion.
15865065|NCT03921502|Procedure|Gall bladder transmural drainage with LAMS|Placing a PAL Axios (Boston Scientific) usually 15x10 mm or 10x10 mm to allow direct cholecystoscopy with a conventional gastroscope or transnasal gastroscope. The placement of the drainage will be performed in the same endoscopic act, by means of an Olympus® sectorial echoendoscope, assisted with X-rays, which allows puncturing the vesicle from the gastric antrum or the duodenal bulb to generate a cholecysto-gastrostomy or cholecysto-duodenostomy respectively. After the puncture of the vesicle from the most optimal anatomical point, it will be tutored with guidance and a Hot Axios® PAL 15x10 mm or 10x10 mm will be *placed on it to generate the anastomosis between the aforementioned structures.
15865066|NCT03921489|Procedure|Subchondroplasty|Calcium phosphate mineral compound injected into the bone marrow lesions
15865067|NCT03921476|Other|Online survey|Online survey completion through Northwestern's REDCap
15865068|NCT03921450|Device|1 Hz rTMS|1 Hz stimulation at 110% of resting motor threshold over supplementary motor area
15865069|NCT03921450|Device|iTBS|50 Hz theta burst stimulation at 80% of resting motor threshold over supplementary motor area
15865070|NCT03921450|Drug|Placebo|1 Hz stimulation with the placebo TMS coil without any magnetic emission
15865368|NCT03919019|Other|Macuprev Group|oral supplementation (Macuprev) 2 capsules per day for 6 months
15865071|NCT03921437|Radiation|decision support intervention|CKD Guardian is the decision-maker and uses the e-book software to develop medical decision-assist tools, and applies this tool and decision-directed mode to introduce and select. The implementation steps include team discussion, option discussion and decision-making. The group is introduced with traditional care instructions for routine care.
15865072|NCT03921424|Biological|V114|15-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) present in Prevnar 13™ plus 2 additional serotypes (22F, 33F) in each 0.5 mL dose.
15865073|NCT03921424|Biological|Prevnar 13™|13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F) in each 0.5 ml dose.
15865074|NCT03921424|Biological|Pneumovax™23|23-valent pneumococcal polysaccharide vaccine containing 23 serotypes (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F) in each 0.5 mL dose
15865075|NCT03921411|Biological|Nemolizumab|Participants received subcutaneous (SC) injection of 30 milligram (mg) of Nemolizumab every 4 weeks (Q4W) over a 16-week treatment period, with a loading dose of 60 mg on Day 1.
15865076|NCT03921385|Device|Augmented Reality Headset|Patients undergoing navigated cranial or spine procedures will acquire standard of care clinical high-resolution imaging to be used for registration purposes intraoperatively. VGA output on the navigation machine will be utilized to project imaging information to the augmented reality headset. The holographic image will then be recorded to assess feasibility and ease of use.
15865077|NCT03921372|Diagnostic Test|Isometric exercise|Squatting for 5 minutes
15865078|NCT03921359|Behavioral|SMARTfit training|For SMARTfit training, participants receive three 1-hour training sessions per week for 8 weeks. During each week, participants will receive physical training focused on six tasks, which are the functional tasks individuals with PD commonly have difficulty with. The six tasks are paired into 3 pairs: (1) sit-to-stand and multi-plane locomotor tasks, (2) gait and reach & grasp, and (3) floor-to-stand; stand-to-floor and single limb standing. Participants will focus on practicing one pair of tasks during each session. There is an additional cognition component that can be manipulated using features provided by SMARTfit.
15865079|NCT03921359|Behavioral|Conventional physical training|For conventional physical training, participants receive three 1-hour training sessions per week for 8 weeks. During each week, participants will receive physical training focused on six tasks, which are the functional tasks individuals with PD commonly have difficulty with. The six tasks are paired into 3 pairs: (1) sit-to-stand and multi-plane locomotor tasks, (2) gait and reach & grasp, and (3) floor-to-stand; stand-to-floor and single limb standing. Participants will focus on practicing one pair of tasks during each session.
15865080|NCT03921346|Device|Mobile device app (PedAMINES™) 1st drug|To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)
15865081|NCT03921346|Device|Mobile device app (PedAMINES™) 2nd drug|To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)
15865082|NCT03921346|Device|Mobile device app (PedAMINES™) 3rd drug|To prepare 4 mL/kg dextrose 10%
15865083|NCT03921346|Device|Mobile device app (PedAMINES™) 4th drug|To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)
15865084|NCT03921346|Device|Conventional method 1st drug|To prepare 0.01 mg/kg epinephrine (0.1 mL/kg of 0.1 mg/mL concentration)
15865085|NCT03921346|Device|Conventional method 2nd drug|To prepare 0.1 mg/kg midazolam (of 5 mg/mL concentration ad 10 mL sodium chloride 0.9%)
15865086|NCT03921346|Device|Conventional method 3rd drug|To prepare 4 mL/kg dextrose 10%
15865087|NCT03921346|Device|Conventional method 4th drug|To prepare 1 mmol/kg sodium bicarbonate (of 4.2% = 0.5 mmol/L concentration)
15865088|NCT03921333|Dietary Supplement|Low dose response efficacy of plant extracts|300mg
15865089|NCT03921333|Dietary Supplement|Middle dose response efficacy of plant extracts|500mg
15865090|NCT03921333|Dietary Supplement|High Dose response efficacy of plant extracts|700mg
15865091|NCT03921333|Dietary Supplement|Placebo|Cellulose microcrystalline
15865092|NCT03921320|Procedure|Bilateral sequential sympathectomy|Bilateral videothoracoscopic sequential R4 sympathectomy
15865093|NCT03921320|Procedure|Unilateral sympathectomy|Unilateral videothoracoscopic R4 sympathectomy in dominant side (right side)
15865094|NCT03921320|Procedure|Contralateral sympathectomy|Contralateral (left side) videothoracoscopic R4 sympathectomy
15865095|NCT03921294|Drug|Emicizumab|bispecific monoclonal antibody binding to activated Factor IX and Factor X
15865096|NCT03921281|Other|scalp acupuncture treatment|"The parameters for scalp acupuncture are set as follows:
~Scalp acupoint selection: The Motor Area of Jiao's Scalp acupuncture and Si shencong (EX-HN1).
~Acupuncture manipulation: Disposable stainless steel needles will be manually inserted in at an approximately 15-degree angle to a depth of 1.5-2.0 cm respectively along the upper point and middle point of the motor area on the scalp. The acupuncture direction of Si shencong (EX-HN1) acupoint is toward the Baihui (GV20) acupoint. the needles will be rotated for at least 200 revolutions per minute for 1 minute every 20 minutes for a total of 60 minutes.
~Treatment course: three times a week, 12 weeks in total."
15865097|NCT03921281|Other|Rehabilitation Treatment|The children with CP will receive the conventional rehabilitation programs as mentioned above. The rehabilitation programs will be carried out three times a week (once every other day) for 12 weeks, and every time, the rehabilitation treatment (PT and OT) will last approximately for 1 hour. All rehabilitation treatments will be carried out by qualified therapists.
15865098|NCT03921268|Drug|AZD1402|AZD1402 (PRS-060) is presented as a solution and dry powder for oral inhalation and belongs to a new class of therapeutics, Anticalin® proteins, which are modified lipocalins. AZD1402 is an inhaled IL-4Rα antagonist, which is being developed as controller therapy for asthma.
15865125|NCT03921034|Drug|Saline|All patients will receive sedation with midazolam and/or fentanyl titrated to comfort during block procedures. Per our standard practice at Ochsner Medical Center, all patients will have either spinal or combined spinal-epidural anesthesia with mepivacaine 1.5% as the primary anesthetic during the surgery and sedation with propofol titrated to comfort. Also per our standard practice at Ochsner Medical Center, multimodal therapy will include ketamine 0.25mg/kg IV (up to 50mg) intraoperatively, dexamethasone 8mg IV intraoperatively, pregablin 150mg PO preoperatively (adjusted to 75mg for age over 70) followed by 75mg nightly (or home gabapentin dose), acetaminophen 1000mg IV followed by 100mg PO every 6 hours postoperatively, and celecoxib 400mg PO on POD #0 followed by 200mg PO daily.
15865099|NCT03921255|Other|Cognitive Bias Modification|There is support that CBM-I may work through the process of cognitive restructuring, and specifically, threat reappraisal. Threat appraisal is a tendency to overestimate the likelihood of harm (i.e., likelihood bias) and/or the negative consequences of anticipated harm (i.e., Clark & Beck, 2010), producing avoidance, thus interfering with effectively reappraising threat, thereby creating a vicious cycle (Beck et al., 1985; Clark & Beck, 2010). CBM-I procedures ensure that an interpretation bias is triggered by the ambiguous scenarios, and participants are then guided to solve the key word in accordance with a healthy response (Grey & Mathews, 2000). The observed effects of CBM-I may stem from active generation of benign or positive meanings in response to ambiguous situations, where threats were previously interpreted (Beadel et al., 2014).
15865105|NCT03921229|Behavioral|Tele-coaching|"Patients will meet with a tele-coach, who is a care team member, via video-calling, on a regular basis for six months to identify and address treatment adherence concern(s)."
15865106|NCT03921190|Procedure|Local anesthesia|Patients scheduled for a dental procedure that requires local anesthesia will be given the injection using two 2 techniques; an open-mouth and closed-mouth techniques
15865107|NCT03921177|Dietary Supplement|Multiple micronutrient supplement|Preconception to 12-weeks gestation: daily (coded) multiple micronutrient supplement containing 15-nutrients (vitamins and minerals) providing an approximate recommended dietary allowance for pregnant women, approximating the UNICEF UNIMAP formulation (UN micronutrient preparation).
15865108|NCT03921177|Drug|Placebo Oral Tablet|Preconception to 12-weeks gestation: identical tablet
15865109|NCT03921164|Procedure|Trans-oesophageal Doppler|"As required by the standard of care of the interventional neuroradiology procedure, the neuroradiologist also cannulates the femoral artery. At the end of the procedure, during catheter withdrawal, pressure waveforms are recorded in the descending thoracic aorta just in front of the esophageal Doppler probe.
~Descending aortic velocity is measured with a transesophageal Doppler CardioQ-ODM+ (Deltex Medical, Chichester, UK) in order to construct the VP Loop in descending thoracic aorta."
15865110|NCT03921164|Procedure|Trans-thoracic echocardiography|Estimation of ventricular diastolic pressure by measuring mitral and aortic flow gradients by echocardiography (EPIQ G7 Philips© or similar) Determination of left ventricular volumes during the cardiac cycle by echocardiography (3D EPIQ G7 Philips© or similar).
15865111|NCT03921164|Procedure|Applanation tonometry|"Measurements using the SphygmoCor radial tonometer (AtCor Medical, Pty Ltd, Sydney, Australia), the most widely used tonometer in clinical research for non-invasive central pressure measurement and pulse wave analysis. The central blood pressure is then estimated using a validated radial-aortic transfer function.
~The tonometer requires prior calibration by mean (MAP) and diastolic (PAD) blood pressure measured with the conventional brachial cuff as validated in the literature."
15865112|NCT03921151|Drug|Mirtazapine 15 MG Oral Tablet|15mg of mirtazapine oral table prior to scan
15865113|NCT03921151|Other|Placebo oral capsule|Oral placebo consisting of dextrose in gelatin capsule prior to scan
15865114|NCT03921138|Other|Histopathologic tube anomalies|Assessment of prevalence of histopathologic tube anomalies (Serous Tubal Intraepithelial Carcinoma (STIC) or tumor protein 53 (p53) lesion)
15865115|NCT03921125|Device|Massimo for Pleth variability index|To assess fluid response
15865116|NCT03921112|Device|lung ultrasound|bedside lung ultrasound will be done for patients
15865117|NCT03921112|Other|routine tools|chest X-ray , ABG, RSBI, Ventilator parameters will be done for all patients
15865118|NCT03921099|Drug|Ascorbic Acid|ascorbic acid is an antioxidant that is expected to prevent nephrotoxicty induced by Vancomycin.
15865119|NCT03921086|Drug|Antihypertensive medication according to the study's algorithm|"Patients with stage 1 hypertension will receive monotherapy and risks of hypotension are negligible. A single antihypertensive lowers blood pressure (BP) on average by 10/5 mmHg.
~Patients with stage 2 hypertension will be initiated on two medications and this is recommended by all international hypertension guidelines and studies have shown prompt BP control with minimal side effects.
~For borderline patients, the investigators will elect to not treat them for blood pressure ranges of BP: 135-140/85-90 mmHg and give them a letter on discharge to be followed up at their local clinic. The letter will detail that they are potentially hypertensive patients and need to be followed up closely in future.
~Patients with Stage 3 hypertension will be referred to the in-hospital physician as per the algorithm."
15865120|NCT03921073|Drug|T-VEC|Participants will receive intralesional injections of T-VEC of up to 4cc. Dosing of T-VEC is dependent of the size of the lesion.
15865121|NCT03921060|Drug|Denosumab|treatment with denosumab every 6 months for up to 5 years
15865122|NCT03921047|Procedure|Biospecimen Collection|Undergo collection of blood samples
15865123|NCT03921047|Other|Laboratory Biomarker Analysis|Correlative studies
15865124|NCT03921034|Drug|Ropivacaine|All patients will receive sedation with midazolam and/or fentanyl titrated to comfort during block procedures. Per our standard practice at Ochsner Medical Center, all patients will have either spinal or combined spinal-epidural anesthesia with mepivacaine 1.5% as the primary anesthetic during the surgery and sedation with propofol titrated to comfort. Also per our standard practice at Ochsner Medical Center, multimodal therapy will include ketamine 0.25mg/kg IV (up to 50mg) intraoperatively, dexamethasone 8mg IV intraoperatively, pregablin 150mg PO preoperatively (adjusted to 75mg for age over 70) followed by 75mg nightly (or home gabapentin dose), acetaminophen 1000mg IV followed by 100mg PO every 6 hours postoperatively, and celecoxib 400mg PO on POD #0 followed by 200mg PO daily.
15865126|NCT03921021|Drug|Telomelysin|OBP-301, the investigational product (IP) is formulated in 20 mM Tris pH 8.0, 25 mM NaCl with 2.5% glycerin, USP by volume. OBP-301 will be injected into the target tumor lesions.
15865127|NCT03921008|Drug|Paclitaxel|-Commercial supply
15865369|NCT03919019|Other|Placebo Group|oral placebo 2 capsules per day for 6 months
15865129|NCT03921008|Procedure|Research blood draw|-Within 1 week (prior to cycle 1 of paclitaxel preferred but not required), pre-radiation therapy (any time weeks 5-7 as long as radiation therapy has not started), post-radiation therapy (day of last fraction), 14 days post-radiation therapy, and within 2 weeks post-surgery
15865130|NCT03920982|Diagnostic Test|Determination of the blood concentration of indoxyl sulfate (IS)|IS concentration will be determined in blood of patients with septic shock and acute kidney injury. IS blood concentration will be done every day during 7 first days after patient will be admitted in intensive care unit. Relation between IS peak serum concentration and mortality at day 28 will be determined.
15865131|NCT03920969|Behavioral|Sports activity|Evaluation of physical activity using the International Physical Activity Questionnaire (IPAQ) short version.
15865132|NCT03920956|Other|ABPM service by Pharmacists|Patients will receive ABPM services provided by a pharmacist and complete a patient satisfaction survey
15865133|NCT03920943|Other|Measurement of temperature using non-invasive means|The study intervention will involve paramedics using the TAT device to measure temperature non-invasively,the first measurements made at least 5 minutes after insertion of the temperature probe (control measurement #1), and also prior to departure from the sending facility (control measurement #2). Once the patient is in the transport vehicle and the vehicle in motion for at least 10 minutes, the paramedics will measure the patient's temperature non-invasively using the TAT. If the transport time exceeds 1 hour, additional measurements taken at 1 hour intervals for the duration of transport (up to a total of 8 hours).
15865134|NCT03920930|Procedure|Late local infiltration analgesia|Patient receive an infiltration of local anaesthetics around the knee directly after total knee replacement for postoperative pain control.
15865135|NCT03920930|Procedure|Early local infiltration analgesia|The local infiltration analgesia is applied in a total of 4 steps during the preparation of the knee joint: 1. after the skin incision, 2. after the capsule incision, 3. after complete exposure of the knee joint, 4. when the posterior knee capsule is reached.
15865136|NCT03920917|Procedure|Cryoballoon Pulmonary Vein isolation|"Pulmonary vein isolation will be performed using a cryoballoon catheter.
~Esophageal temperature will be monitored to prevent esophageal injury.
~A 28mm second or third cryoballoon catheter will be used.
~Esophageal temperature will be monitored to prevent esophageal injury.
~Cryoablation will be performed for 180 secs at -45°C or below on condition that the pulmonary vein is occluded with a cryoballoon.
~CMAP (compound motor action potential) monitoring will be done to avoid phrenic nerve damage during the freezing of the right superior pulmonary vein.
~The procedure and cryoablation times will be evaluated.
~Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design."
15865137|NCT03920917|Procedure|Radiofrequency Pulmonary Vein isolation and Additional Right Atrial linear ablation|"Pulmonary vein isolation will be performed using a radiofrequency catheter.
~Additional cavo-tricuspid isthmus ablation will be performed with a radiofrequency catheter.
~Additional superior vena cava-right atrial septal linear ablation will be performed with a radiofrequency catheter.
~If any other trigger came from beyond pulmonary vein is detected after the administration of isoproterenol, additional local radiofrequency ablation will be followed.
~Evaluated the procedure and radiofrequency ablation time.
~Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design."
15865138|NCT03920904|Other|Collection of blood samples|Nine blood samples will be collected to determine bupivacaine pharmacokinetics at T10min, T20min, T30min, T45min, T60min, T90min, T120min, T180min, and T240min. T0 will be defined as the end of bupivacaine injection.
15865139|NCT03920891|Procedure|Cryoballoon Pulmonary Vein isolation|"Pulmonary vein isolation will be performed using a cryoballoon catheter.
~Esophageal temperature will be monitored to prevent esophageal injury.
~A 28mm second or third cryoballoon catheter will be used.
~Esophageal temperature will be monitored to prevent esophageal injury.
~Cryoablation will be performed for 180 secs at -45°C or below on condition that the pulmonary vein is occluded with a cryoballoon.
~CMAP (compound motor action potential) monitoring will be done to avoid phrenic nerve damage during the freezing of the right superior pulmonary vein.
~The procedure and cryoablation times will be evaluated.
~Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design."
15865140|NCT03920891|Procedure|Radiofrequency Pulmonary Vein isolation and Additional Right Atrial linear ablation|"Pulmonary vein isolation will be performed using a radiofrequency catheter.
~Additional left atrium posterior wall isolation, left atrium anterior wall linear ablation, cavo-tricuspid isthmus ablation, superior vena cava-right atrial septal ablation.
~If any other trigger came from beyond pulmonary vein is detected after the administration of isoproterenol, additional local radiofrequency ablation will be followed.
~Evaluated the procedure and radiofrequency ablation time.
~Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design."
15865141|NCT03920878|Drug|Aflibercept injected Pre- and Post-operatively|Three injections of aflibercept before cataract surgery, and aflibercept injections after surgery within 14-21 days of the day of surgery (number of injections depends on clinical exam findings, visual acuity and retinal thickness).
15865142|NCT03920878|Drug|Aflibercept injected intraoperatively|Three injections of aflibercept before surgery and one injection of aflibercept during the course of the surgery by cataract surgeon.
15865143|NCT03920865|Drug|Risdiplam|5 milligram (mg) oral dose administered in fasted state
15865144|NCT03920852|Drug|Ruxolitinib cream|Ruxolitinib 1.5% cream applied twice daily.
15865145|NCT03920839|Drug|Retifanlimab|INCMGA00012 administered intravenously every 3 weeks.
15865146|NCT03920839|Drug|Gemcitabine|Gemcitabine administered intravenously on Days 1 and 8 of 21-day cycles.
15865147|NCT03920839|Drug|Cisplatin|Cisplatin administered intravenously on Day 1 of 21-day cycles.
15865148|NCT03920839|Drug|Pemetrexed|Pemetrexed administered intravenously on Day 1 of 21-day cycles.
15865149|NCT03920839|Drug|Carboplatin|Carboplatin AUC5 or AUC6 administered intravenously on Day 1 of 21-day cycles.
15865150|NCT03920839|Drug|Paclitaxel|Paclitaxel administered intravenously on Day 1 of 21-day cycles.
15865151|NCT03920826|Device|transcranial alternating current stimulation|The alternating current is administered through medical grade conductive pads that are produced specifically for the Nexalin technology. The pads are places on the forehead and behind each ear, and are connected to the Nexalin device with thin cables. Intervention will be implemented with a tACS device with gamma-frequency (40 Hz) and a peak-to-peak amplitude of 15mA, 30 one-hour sessions in 3 weeks (21 days).
15865493|NCT03917914|Drug|Placebo Oral Tablet|As in arm description
15865152|NCT03920826|Device|sham stimulation|Electrodes will also be put on patient's forehead and behind each ear. The sham stimulator has the exactly same appearance with the true stimulator. Participants and operators cannot determine whether the stimulator is true based on its appearance or patients' feelings. However, when the device is started, no current flows through the electrodes. Participants in this controlled group will also receive sham stimulations with 30 one-hour sessions in 21 days.
15865153|NCT03920813|Drug|Mercaptopurine|Dose of mercaptopurine was adjusted to maintain a target white blood cells (WBC) between 2.0-3.0 × 109/L.
15865154|NCT03920800|Other|Data extraction from medical files|Data extraction from medical files
15865155|NCT03920800|Biological|Immunohistochemistry|Immunohistochemistry with Ki67 and p16 antibodies on residual samples, if this had not been foreseen in the standard of care management of the patient.
15865156|NCT03920787|Dietary Supplement|Inofolic Combi|Myo-inositol 1100 mg + D-Chiro-inositol 27,6 mg + Folic Acid 400 μg. 2 capsules every day for 1 month.
15865157|NCT03920787|Other|Placebo|2 capsules every day for 1 month
15865158|NCT03920761|Device|EarlySense Insight system|a small piezoelectric sensor pad that can be placed under the mattress and provide contact-free monitoring by measuring and recording a patient's vital signs and motion parameters
15865159|NCT03920761|Device|Advanced Neonatal Epidermal System|a system of neonatal non-invasive adhesive sensors. Sensors are attached directly on the patient's body and are capable of continuously measuring and recording heart rate, respiratory rate, oxygen saturation, and skin temperature.
15865160|NCT03920748|Other|Group D|According to Cormack-Lehane (CL) Classification; laryngoscopic view grade 3-4 is defined as Group D
15865161|NCT03920748|Other|Group E|According to Cormack-Lehane (CL) Classification; laryngoscopic view grade 1-2 is defined as Group E
15865162|NCT03920722|Drug|Rituximab|1 gram IV on Day 1 and 15 after premedication with 100 mg méthylprednisolone, 1 gramm paracetamol and 5 mg dexchlorpheniramine
15865163|NCT03920722|Drug|placebo|Placebo-Rituximab 1 gram IV on Day 1 and 15 after premedication with 100 mg méthylprednisolone, 1 gramm paracetamol and 5 mg dexchlorpheniramine
15865164|NCT03920709|Other|Blood sample and Nasal swabs (right an left) samples|"Nasal swabs (right and left) will be performed (FLOQSwabTM)
~Blood samples of 20 mL EDTA will be taken in addition to the current care report"
15865165|NCT03920683|Other|Data collection|Retrospective : data from medical record Prospective : vital statuts from follow-up phone call
15865166|NCT03920670|Device|TetraGraph (TG)|TetraGraph device is a neuromuscular transmission monitor capable of estimating the depth of neuromuscular block in anesthetized patients who received neuromuscular blocking agents. TetraGraph uses EMG to measure the muscle action potentials that are generated in response to percutaneous electrical neurostimulation. Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis will be measured.
15865167|NCT03920670|Device|ToFscan (TS)|ToFscan is a nerve stimulator module used for the measurement of neuromuscular transmission via accelerometry. ToFscan was developed by Drager Technologies, Canada, and it uses a three-dimensional piezoelectric sensor that attaches to the thumb via a hand adapter to measure acceleration in multiple planes (Murphy et al, 2018). Following simultaneous ulnar nerve stimulation on each arm, the response of the adductor pollicis will be measured.
15865168|NCT03920657|Drug|Deferasirox|Fixed dose of 3.5 mg/kg/day of DFX FCT
15865169|NCT03920644|Drug|Scopolamine Transdermal Patch [Transderm Scop]|Current Motion Sickness treatment, 1 patch behind the ear.
15865170|NCT03920644|Drug|Scopolamine|IND, up to 6 administration of intranasal gel.
15865171|NCT03920644|Drug|Placebo Patch|Placebo Patch, 1 patch behind the ear.
15865172|NCT03920644|Drug|Placebo Gel|Placebo Gel,up to 6 administration of intranasal gel.
15865173|NCT03920631|Drug|Nivolumab|Nivolumab (1 mg/Kg or 3 mg/kg) every 2 weeks per cohort dose level and schedule
15865174|NCT03920631|Biological|Microtransplantation|HLA-mismatched peripheral blood stem cells
15865175|NCT03920618|Drug|Entecavir|Patients would receive treatment of oral entecavir (ETV) 0.5 mg once per day.
15865176|NCT03920618|Drug|Tenofovir Disoproxil Fumarate|Patients would receive treatment of oral tenofovir disoproxil fumarate (TDF) 300 mg once per day.
15865177|NCT03920618|Drug|Tenofovir Alafenamide|Patients would receive treatment of oral tenofovir alafenamide (TAF) 25 mg once per day.
15865178|NCT03920605|Drug|Tenofovir Disoproxil Fumarate|Patients would receive oral Tenofovir Disoproxil Fumarate 300mg once per day.
15865179|NCT03920605|Drug|Peginterferon Alfa-2a|Patients would receive subcutaneous injection of Peginterferon Alfa-2a 180 μg once per week.
15865180|NCT03920605|Drug|Peginterferon Alfa-2b|Patients would receive subcutaneous injection of Peginterferon Alfa-2b 80 μg once per week.
15865181|NCT03920592|Behavioral|Virtual Reality of Bullying|"Immersive videos (360º) filmed by 12-14 year old pupils who, guided by professional actors, represented the subjective experience of bullying.
~Eight different potential situations designed depending on the sex of the pupil were filmed:
~Girls:
~Classmates steal her personal diary
~Classmates tear her clothing
~Classmates insult her and steal her belongings
~Classmates deliberately exclude her in class
~Boys:
~Classmates exclude him while playing with a ball
~Classmates bother him in the dining room
~Classmates insult and steal him in class
~Classmates insult him and steal his belongings"
15865182|NCT03920579|Drug|CKD-386 formulation 1|A single oral dose of 1 tablet under fasting conditions for each period
15865183|NCT03920579|Drug|CKD-386 formulation 2|A single oral dose of 1 tablet under fasting conditions for each period
15865184|NCT03920579|Drug|D326, D337 and D013|A single oral dose of 3 tablets(D326, D337 and D013) under fasting conditions for each period
15865185|NCT03920566|Other|Anti-Xa level|Anti-Xa level taken before commencing enzalutamide and repeated after 4 weeks of treatment
15865186|NCT03920553|Biological|Hyaluronic acid|Topical application of hyaluronic acid following Laser assisted frenectomy
15865187|NCT03920540|Combination Product|GC1111|GC1111 is 0.5mg per kg of body weight once weekly to be administered slowly by intravenous infusion.
15865188|NCT03920540|Combination Product|Comparator|Comparator is 0.5mg per kg of body weight once weekly to be administered slowly by intravenous infusion.
15865189|NCT03920527|Drug|Itraconazole 400 mg|Duration of itraconazole
15865190|NCT03920514|Drug|hCG|Women will be given hCG before or with IUI
15865494|NCT03917901|Other|Anxiety Sensitivity Training|Computerized Single-Session Anxiety Sensitivity Reduction Program
15865191|NCT03920501|Behavioral|Tele-Critical Care|Daily multidisciplinary rounds with a board certified physician through tele-critical care focusing on: 1) diagnosis; 2) active problems; and 3) therapeutic goals. In addition, the management of health care quality indicators will be conducted by a specially trained (Science of Improvement) board-certified intensive care physician.
15865192|NCT03920475|Drug|Sertraline or venlafaxine|Patients were treated as needed with sertraline or venlafaxine following the official guidelines, starting with a dose of 25 mg/d or respectively 37,5 mg/day. The starting dose could be increased during the course of the treatment as clinically needed according to guide lines.
15865193|NCT03920475|Diagnostic Test|Immune parameters|Serum was taken before, during an after treatment for measurement of different immune parameters.
15865194|NCT03920462|Device|Programme of intelligent electric bike for health|It is a programme of 6 excursions with an intelligent electric bike for health and connected vests during 1 month (two excursions per week according the weather)
15865195|NCT03920449|Drug|Botulinum Toxins|In group I (BT injection), 21 U will be injected in 3 divided doses through the internal anal sphincter at 3,9, and 12 o'clock. In the Egyptian market two commercial forms are available; botulinum toxin type A (Botox 100 IU/vial; Coolock, Dublin, Ireland), and abobotulinumtoxin A (Dysport 500 U/vial; Ipsen Biopharm Ltd, Wrexham, UK). In case of Dysport it should be remembered that dosing is on a ratio of approximately 1 to 3, meaning that 50 IU of Botox have the same effect as 150 IU of Dysport.
15865196|NCT03920449|Procedure|Posterolateral internal sphincterotomy|In group II (PIAS), A 1.5 to 2-cm circumferential skin incision will be placed at 5 o'clock position outside the anal verge using an electrocautery device. Dissection will be proceeded through the intersphincteric groove to separate both IAS and external anal sphincter (EAS). Then, the IAS will be identified by its characteristic white fibers, separated from the anal mucosa, and assessed under direct vision. Subsequently, about 50 % of the IAS will be divided at 5 o'clock position and any skin tags or hypertrophied anal papillae will be removed leaving the skin incision open to allow drainage.
15865197|NCT03920436|Dietary Supplement|infrared water group|This group takes 1,8 L of drinking water using a tumbler that emits far infrared rays at room temperature.
15865198|NCT03920436|Dietary Supplement|sham group|This group takes 1,8 L of drinking water using a tumbler at room temperature.
15865199|NCT03920423|Procedure|improvement of arterial depth|deepen radial arterial depth by injection of saline to more than deep cutoff point relative to result.
15865200|NCT03920410|Other|serotonergic stimulation|Increase of serotonergic activity by a single oral administration of 10 mg Escitalopram, a Selective Serotonin Reuptake Inhibitor (SSRI), packed in a coloured hydroxypropylmethylcellulose capsule.
15865201|NCT03920410|Other|no serotonergic stimulation|Oral administration of a placebo. The placebo will consist of a coloured hydroxypropylmethylcellulose capsule filled with microcrystalline cellulose.
15865202|NCT03920397|Biological|Infusion of adipose tissue-derived stem/stromal cells and oral Cholecalciferol supplementation|The investigators will acess area under the curve of C-peptide after a liquid mixed meal (Glucerna®), considering the time 0 (basal), 30, 60, 90 and 120 minutes in each follow-up outpatient visit (3 [T3], 6 [T6], 12 [T12], 18 [T18], and 24 [T24] months after the adipose tissue-derived stem/stromal cells infusion). Other Clinical and Pancreatic Function Evaluation that wil be assess are: Weight, height, body mass index (BMI), blood pressure, heart frequency, frequency of hypoglycemia and insulin dose/kg of body weight, blood count, lipids, renal and hepatic function, thyroid stimulating hormone, free tyroxine, antithyroglobulin antibody, calcium, phosphorus and 25-Hydroxy Vitamin D.
15865203|NCT03920384|Behavioral|Experimental intervention arm|Psychological therapy for psychosis with new therapy components
15865204|NCT03920384|Behavioral|Active control arm|Standard psychological therapy for psychosis without new therapy components
15865205|NCT03920371|Other|gamma camera imaging|Following the administration of the routine radiopharmaceutical and the standard wait before clinical diagnostic imaging, additional research gamma camera imaging is carried out
15865206|NCT03920358|Device|FRED, FRED Jr and FRED X|Subjects aged ≥ 18 requiring treatment for an unruptured or recanalized intracranial aneurysm
15865207|NCT03920345|Device|MultiZYTE|Subjects can be treated either unilateral or bilateral, depending on their condition and the recommended treatment by the surgeon. The decision is a clinical one and is not influenced by the decision of whether to be included in the study or the subsequent outcomes and QoL analysis.
15865208|NCT03920319|Drug|Bupropion|Bupropion 150 mg sustained release
15865209|NCT03920319|Other|Placebo|
15865210|NCT03920306|Drug|oral anti-acid treatment|This study investigates a bundle of three commonly used treatments
15865211|NCT03920293|Biological|Ravulizumab|Concentrated sterile, preservative-free aqueous solution (10 milligrams [mg]/milliliter [mL]) in single-use, 30-mL vial for intravenous (IV) infusion. Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight.
15865212|NCT03920293|Drug|Placebo|Matching, sterile, preservative-free aqueous solution in single-use, 30-mL vial for IV infusion. Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight.
15865214|NCT03920254|Drug|TD-1473 Dose A|See Arm description
15865215|NCT03920254|Drug|TD-1473 Dose B|See Arm description
15865216|NCT03920254|Drug|TD-1473 Dose C|See Arm description
15865217|NCT03920241|Behavioral|Mindfulness-Based Stress Reduction|"The MBSR is an 8-week standardized program (Kabat-Zinn, 1990) consisted of 2.5-hour of face-to-face weekly sessions, and 45 minutes of daily home formal and informal practices. Training will be conducted in groups of 20-30 participants. During the program, different mindfulness practices are performed, including focused attention on the breath, open monitoring of awareness in body-scanning, prosocial meditation (i.e. loving kindness and compassion) and gentle yoga.
~Training is delivered by certificated instructors by the University of Massachusetts Centre for Mindfulness (https://www.umassmed.edu/cfm/)."
15865253|NCT03919968|Behavioral|Martial Arts|The training will be performed 3 times a week, for 12 weeks, during 60 minutes, being that will be divided into 20 min of general exercises, 20 min of specific exercises and 20 min of fight simulation and / or play activities. The activities will be carried out in a way adapted for the elderly. Will be used kickers, gauntlets, thorax and head protectors, shin guards, gloves, and other devices.
15865495|NCT03917901|Other|Health Control|Computerized Single-Session Health Information Control
15865218|NCT03920241|Behavioral|Compassion Cultivation Training|"The CCT is an 8-week standardized program (Jinpa, 2010; Jazaieri et al. 2013, 2014) consisting of 2.5-hour of face-to-face weekly sessions and 30 minutes of daily home formal and informal practices. Training will be conducted in groups of 20-30 participants. The CCT consists of six sequential steps: 1) Settling the mind and learn how to focus it; 2) Loving kindness and compassion for a loved one practice; 3) Loving kindness and compassion for oneself practice; 4) compassion toward others, embracing shared common humanity and developing appreciation of others; 5) compassion toward others including all beings; and 6) active compassion practices (Tonglen) which involve explicit evocation of the altruistic wish to do something about others' suffering.
~CCT program is delivered by certificated instructors by the University of Stanford Centre for Compassion and Altruism Research and Education (http://ccare.stanford.edu/)."
15865219|NCT03920241|Other|Control Group|A group of participants, matched by age, gender, and meditation experience is selected to compare their performance on experimental lab tasks in relation to the MBSR and CCT participants.
15865220|NCT03920228|Drug|PTX-022|PTX-022 QTORIN
15865221|NCT03920228|Drug|Placebo|Placebo topical
15865222|NCT03920215|Drug|OC-01 (varenicline) nasal spray|Long-term follow-up study is to evaluate the safety of OC-01 Nasal Spray at 6 months and 12 months post treatment in the OPP-002 study.
15865223|NCT03920189|Diagnostic Test|echocariographic ultrasound|left ventricular diastolic function description
15865224|NCT03920176|Diagnostic Test|Computed tomography coronary angiography|CTCA >64 detector row scanner
15865225|NCT03920176|Other|ASSIGN Score|ASSIGN Cardiovascular Risk Score
15865226|NCT03920163|Other|Enhanced Recovery Measures|Perioperative measures
15865227|NCT03920150|Drug|Vitamin D3|Patient will be treated with 3 doses of alcoholic solution for 3 months.
15865228|NCT03920150|Drug|Vitamin D oily capsules|Patient will be treated with 3 capsules for 3 months.
15865229|NCT03920150|Drug|Vitamin D oily capsules|Patient will be treated with weekly capsules for an individually calculated number of weeks.
15865230|NCT03920137|Behavioral|UP-ST Therapy|Phase 1 analyses will focus primarily on demonstrating feasibility and utility of the new UP-ST intervention. Feasibility will be determined by examining the proportion of individuals who 1) complete each module of the UP-ST treatment, 2) complete a full course of the UP-ST treatment, and by 3) benchmarking participant ratings of treatment credibility, expectancy, and satisfaction with corresponding ratings from our previous clinical trials examining the UP or ST interventions. The investigators will include and examine outcomes on the same measures that will be used in phase 2, but due to the sample size our analyses for Phase 1 will focus on intraindividual effect sizes (with 95% CI) for continuous smoking, anxiety, and depression outcomes
15865231|NCT03920137|Behavioral|Standard Therapy|In the control group therapists will hold standard smoking cessation therapy sessions.
15865232|NCT03920137|Device|Nicotine Patch|Nicotine patches will be worn in tandem with UP-ST therapy
15865233|NCT03920124|Other|Step and walk-based high intensity interval exercise|"Four hospital-based trials will include two step-based (3 x 20 sec with 120 sec rest, or 3 x 60 sec with 60 sec rest) and two walking-based (e.g. 3 x 60 sec with 60 sec rest or 3 x 180 sec with 180 sec rest) interval exercise protocols, in a randomised and counterbalanced order.
~Unsupervised (At home) exercise intervention will incorporate patients' preferred stair and/or walking-based interval exercise (from those completed during hospital trials). Initially patients will complete their chosen protocol three days per week, and then gradually progress exercise load (i.e. reps, work-to-rest ratio, and/or sessions per week) as appropriate, to a maximum of 6 x 60 sec stepping / 5 x 180 sec walking, five times per week (i.e. maximum of ~30 min daily or ~150 min weekly)."
15865234|NCT03920111|Biological|IMOJEV|live attenuated Japanese encephalitis (JE) vaccine IMOJEV®
15865235|NCT03920098|Other|Altered metabolic milieu during first full term pregnancy|The altered metabolic milieu is defined as a fasting glucose level >100 mg/dL at the first trimester of pregnancy by national guidelines. Altered metabolic milieu during the second trimester (24-28 weeks of pregnancy) is defined as a fasting glucose levels > 92 mg/dL and/or plasma glucose levels > 153 mg/dL two hours afterload in the oral glucose tolerance test according to ADA guidelines or a fasting glucose >100 mg/dL and/or > 140 mg/dL two hours afterload in the oral glucose tolerance test according to national guidelines.
15865236|NCT03920085|Device|OneTouch Verio|OneTouch Verio Blood Glucose Monitoring System.
15865237|NCT03920085|Device|OneTouch Select Plus|OneTouch Select Plus Blood Glucose Monitoring System.
15865238|NCT03920085|Device|OneTouch Ultra|OneTouch Ultra Blood Glucose Monitoring System.
15865239|NCT03920072|Drug|Burosumab|Burosumab is a sterile, clear, colourless and preservative free solution supplied in single-use 5ml vials containing 1mL of burosumab at a concentration of 30mg/mL
15865240|NCT03920059|Drug|Mycophenolate Mofetil|"Description Each capsule contains Mycophenolate mofetil 250 mg. Presentation / Packing Cap 250 mg (white to off white powder, light blue/peach hard gelatin, imprinting with MMF on cap and 250 on body) x 10 x 10's.
~Storage Store below 30 degree Celcius."
15865241|NCT03920046|Behavioral|Control Group|The prevalence of laryngospasm in sedation applied to endoscopic intervention whose parents no smoking.
15865242|NCT03920033|Radiation|Salvage radiation therapy|Salvage radiation therapy for biochemical recurrence
15865243|NCT03920020|Other|the concentric isokinetic exercise group|concentric isokinetic exercises
15865244|NCT03920020|Other|the eccentric isokinetic exercise group|eccentric isokinetic exercises
15865245|NCT03920020|Other|the control group|conventional physiotherapy and standard therapeutic exercises predetermined by us
15865246|NCT03920007|Drug|SAR439483|Pharmaceutical form:Solution for intraocular administration Route of administration: Subretinal injection
15865247|NCT03920007|Drug|SAR439483 Diluent Solution|Pharmaceutical form:Solution for parenteral use Route of administration: Subretinal injection
15865248|NCT03920007|Drug|Prednisone|Pharmaceutical form:Tablet Route of administration: Oral
15865249|NCT03920007|Drug|Triamcinalone Acetonide|Pharmaceutical form:Suspension Route of administration: Peri-ocular injection
15865250|NCT03920007|Drug|1% Prednisolone|Pharmaceutical form:Suspension Route of administration: Drops
15865251|NCT03920007|Drug|Trimethoprim/polymyxin B|Pharmaceutical form:Solution Route of administration: Topical
15865252|NCT03919981|Other|Blood sampling|25 mL blood sample will be collected on citrate tubes for osteoclastic analysis.
15880384|NCT03802032|Drug|KY jelly|topical KY jelly
15865254|NCT03919968|Behavioral|Functional Training|The training will be performed 3 times a week, for 12 weeks, during 60 minutes, being that will be divided into 20 min of general exercises, 20 min of specific exercises and 20 min of play activities. The activities will be carried out in a way adapted for the elderly. Will be carried out neuromotor control / coordination, balance, flexibility and static and dynamic stabilization. They will also have acceleration and deceleration activities, rotation and counter-rotation, extension and counter-extension, flexion and counter-flexion.
15865255|NCT03919955|Drug|Atomoxetine|Atomoxetine 80 mg, per mouth, before bed
15865256|NCT03919955|Drug|Oxybutynin|Oxybutynin 5 mg, per mouth, before bed
15865257|NCT03919955|Drug|Placebo|Placebo, per mouth, before bed
15865258|NCT03919942|Other|OxyFlower gel|the region with pericoronitis was debrided using gauze and curettes, with copious irrigation with sterile saline solution. At this moment, the gel was applied topically under the pericoronal hood, with a standard volume of 2microIiters, using a dosing syringe. Then, participants received instructions on oral hygiene and how to use the gel at home, twice a day for one week. After 30 days, it was performed third molar removal or distal wedge removal
15865259|NCT03919942|Other|Chlorhexidine gel|the region with pericoronitis was debrided using gauze and curettes, with copious irrigation with sterile saline solution. At this moment, the gel was applied topically under the pericoronal hood, with a standard volume of 2microIiters, using a dosing syringe. Then, participants received instructions on oral hygiene and how to use the gel at home, twice a day for one week. After 30 days, it was performed third molar removal or distal wedge removal.
15865260|NCT03919942|Other|Placebo gel|the region with pericoronitis was debrided using gauze and curettes, with copious irrigation with sterile saline solution. At this moment, the gel was applied topically under the pericoronal hood, with a standard volume of 2microIiters, using a dosing syringe. Then, participants received instructions on oral hygiene and how to use the gel at home, twice a day for one week. After 30 days, it was performed third molar removal or distal wedge removal
15865261|NCT03919929|Drug|Semaglutide 3mg and 7mg [Rybelsus]|Once daily oral tablet of semaglutide for 4 months
15865262|NCT03919929|Other|Weight loss diet|Prescribed weight loss diet to match weight loss in Drug arm
15865263|NCT03919916|Procedure|Serratus plane block|Placement of initial local anaesthetic bolus and catheter for continuous infusion in the plane between latissimus dorsi and serratus anterior in the midaxillary line at the level of the 5th rib
15865264|NCT03919916|Other|Patient controlled analgesia|Computerised pump device facilitating the patient self administration and titration as needed of morphine
15865265|NCT03919890|Drug|ONO-7684|Single ascending doses for cohorts A1-A8 and multiple ascending doses cohorts B1-3
15865266|NCT03919890|Drug|ONO-7684 Placebo|Placebo comparator
15865267|NCT03919877|Other|Dietary|Dietary counseling based on results of CGM analyses.
15865268|NCT03919864|Behavioral|CONNECT Intervention|Participants will be included in a multi-component e-tool with brief educational videos, an assessment of multidimensional supportive care needs, a tailored resource list and an optional automated referral to a caregiver navigator. Two weeks after baseline participants will receive re-education and an optional referral.
15865269|NCT03919864|Behavioral|CONTROL Group|Participants will receive a generic printed list of hospital, community, and national supportive care resources.
15865270|NCT03919851|Drug|Antibiotics|Administration of antibiotics
15865271|NCT03919838|Dietary Supplement|Probiotics|A half of the participants will be randomly allocated to the probiotics group. They will receive two probiotics lozenge before falling asleep for 8 weeks. Clinical examination will be conducted before study and after 8 weeks.
15865272|NCT03919838|Dietary Supplement|Placebo - No probiotics|A half of the participants will be randomly allocated to the placebo group. They will receive two no probiotics lozenge before falling asleep for 8 weeks. Clinical examination will be conducted before study and after 8 weeks.
15865273|NCT03919812|Dietary Supplement|Cholecalciferol supplementation|supplementation received by subject according to their vitamin D status: insufficiency or deficiency.
15865276|NCT03919786|Procedure|topical local anesthesia of pulmonary vein combined with vagus nerve block|"Injecting 1% lidocaine 1.5ml+0.375% ropivacaine 1.5ml into vascular sheaths of all pulmonary vein of the surgery side at the beginning of surgery operation.
~Wrapping all pulmonary vein of the surgery side with cotton sheet infiltrated with 1% lidocaine+0.375% ropivacaine at the end of surgery operation.
~Blocking vagus nerve above the aortic vein on the right side of the trachea with 1% lidocaine 1ml+0.375% ropivacaine 1ml after exposing the pleural apex."
15865277|NCT03919773|Drug|IVIG|"If you participate in this study there will be 18 scheduled treatment infusions during the 30 week study period. All the study visits and treatment visits will be outpatient visits.
~Once you qualify to participate in the study and begin treatment, there will be two 12 week treatment periods separated by a 6 week washout period. The infusion visits will take approximately 3-4 hours each."
15865278|NCT03919773|Drug|Albumin|This will be the matching placebo used in the study.
15865279|NCT03919760|Behavioral|NAVIGATE|"NAVIGATE was developed in consultation with clinical and research experts, biostatisticians, health economists, consumers, family members, advocacy groups, and government officials. It is a form of coordinated specialty care for first episode psychosis consisting of 4 key intervention components:
~individualized medication management using a decision support tool;
~a package of psychoeducation and a blend of evidence-based psychotherapies called individual resiliency training (IRT);
~supported employment and education (SEE);
~a family education program"
15865280|NCT03919721|Behavioral|Applied Behavioral Analysis|Children are receiving Applied Behavioral Analysis therapy to treat their autism. Therapy is comprised of 15-20 discrete programs that are intended to shape specific behaviors. Tutors collect data on child's performance towards goals. For each child, some of the programs will be tracked with paper data collection methods, others will use electronic data collection. This study is to test the usefulness of the electronic data collection system to replace paper in existing interventions.
15865281|NCT03919708|Device|Retinal Birefringence Imager|Device is a hand-help object approximately the size of a brick, and is held, by the user, 30cm away from the patient/subject. The subject peers in to an aperture that includes a fixation target that is in the shape of a smiley face. During this time, a ring of LED lights illuminates the eye and captures an image of the retina in approximately 3 seconds. The results instantaneously identify the presence of amblyopia / strabismus.
15865282|NCT03919695|Behavioral|Behavioral and Structural Intervention|"The intervention has two components; a structural component and a behavioral component.
~Structural component: This component is about receiving work payments via mobile money instead of cash.
~Behavioral component: This component includes feedback on alcohol screening, counseling, client-centered goal setting, self-monitoring, financial literacy training, and text message reminders of life/savings and healthy living goals."
15865283|NCT03919695|Behavioral|Screening and Referral|Alcohol screening and referral
15865284|NCT03919682|Other|Experimental: Training, Phase 1|Weeklong training in signs, symptoms and treatability of breast cancer, performance of clinical breast exam, and structured algorithms for management of breast complaints followed by regular mentorship for health center nurses. CHWs received a one-day training in breast awareness and how to educate communities about breast health.
15865285|NCT03919682|Other|Experimental: Training, Phase 2|Weeklong training in signs, symptoms and treatability of breast cancer, performance of clinical breast exam, and structured algorithms for management of breast complaints followed by regular mentorship for health center nurses. CHWs received a one-day training in breast awareness and how to educate communities about breast health.
15865286|NCT03919669|Drug|All Subjects|All subjects will be given the experimental tau PET radioligand [18F]MK-6240
15865287|NCT03919656|Drug|Dapagliflozin 10 mg|Dapagliflozin 10 mg daily in a green, plain, diamond shaped, film coated tablet (orally)
15865288|NCT03919656|Drug|Placebo Oral Tablet|Green, plain, diamond shaped, film coated tablet (orally). Does not contain active ingredient
15865289|NCT03919630|Other|Thrust Mobilization|Once therapist has assessed subject and has found the patients most comparable sign they will be performing a high velocity thrust at the end of the patients available range, as described by Maitland's Approach. The thrust will be performed only once. The therapist will perform either a localized cervical rotation thrust which primary movement is rotation or a longitudinal cephalad C1 and C2 thrust, both targeting the upper cervical spine
15865290|NCT03919630|Other|Non-Thrust Mobilizations|Therapists will perform unilateral posterior to anterior mobilization (UPA) or central posterior to anterior (CPA) mobilizations grades I-IV as described above by Maitland concepts at levels C0-C3 which reproduce the patient's most comparable sign. Therapists will be instructed to perform 3x 30 second bouts of mobilizations at that level.
15865291|NCT03919617|Drug|REMD-477|4-Week, open-label, once weekly subcutaneous injection with 70mg REMD-477.
15865292|NCT03919604|Procedure|Extracorporeal Life Support|Any extracorporeal blood treatment technique for respiratory and/or cardiac support
15865293|NCT03919591|Other|Challenge virus RSV-A Memphis 37b|Each subject will receive one titre of virus, which will be up to approximately 4.5 log10 PFU.
15865294|NCT03919578|Biological|Recombinant Hepatitis B vaccine|Recombinant Hepatitis B vaccine is an inactivated HbsAg produced in yeast cells (Hansenula polymorpha) using recombinant DNA technology. It is a whitish liquid produced by culture genetically engineered yeast cell which carry the relevant gene of the HbsAg. The inactivated HbsAg (bulk) is imported from Serum Institute of India and then formulated and filled at Bio Farma.
15865295|NCT03919578|Biological|Recombinant Hepatitis B (Bio Farma)|Recombinant Hepatitis B vaccine is an inactivated HbsAg produced in yeast cells (Hansenula polymorpha) using recombinant DNA technology. It is a whitish liquid produced by culture genetically engineered yeast cell which carry the relevant gene of the HbsAg. The inactivated HbsAg (bulk) is imported from The Janssen Vaccine Corp and then formulated and filled at Bio Farma.
15865296|NCT03919565|Drug|Tenofovir Disoproxil Fumarate|Patients would receive oral Tenofovir Disoproxil Fumarate 300mg once per day.
15865297|NCT03919565|Drug|Peginterferon Alfa-2a|Patients would receive subcutaneous injection of Peginterferon Alfa-2a 180 μg once per week.
15865298|NCT03919565|Drug|Peginterferon Alfa-2b|Patients would receive subcutaneous injection of Peginterferon Alfa-2b 80 μg once per week.
15865299|NCT03919552|Drug|Docetaxel,Carboplatin|Patients receive docetaxel (75mg/m2 on day 1), carboplatin (AUC 4 on day 1) every three weeks for two cycles before the radiotherapy.
15865300|NCT03919552|Drug|Docetaxel,Cisplatin|Patients receive docetaxel (75mg/m2 on day 1), cisplatin (75mg/m2 on day 1) every three weeks for two cycles before the radiotherapy.
15865301|NCT03919552|Radiation|Carboplatin-based concurrent chemoradiotherapy|Patients receive radical radiotherapy and carboplatin (AUC 5) every three weeks for three cycles during radiotherapy.
15865302|NCT03919552|Radiation|Cisplatin-based concurrent chemoradiotherapy|Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
15865303|NCT03919539|Diagnostic Test|5hmc testing|NGS
15865304|NCT03919526|Biological|anti-CD19/CD22 CAR-T cells|Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-CD22 CARs
15865305|NCT03919526|Drug|Fludarabine|30mg/m2/d
15865306|NCT03919526|Drug|Cyclophosphamide|300mg/m2/d
15865307|NCT03919513|Device|inspiratory pressure threshold device|The threshold loading device is composed of a mouth -piece attached to a small plastic cylinder that contains a spring-loaded poppet value. The valve opens to permit inspiratory flow only once the person has generated adequate negative intrathoracic pressure to condense the spring.
15865308|NCT03919500|Drug|EPO|Infants in EPO group are administered 500IU/kg intravenously within 72 hours after birth every other day for 2 weeks.
15865309|NCT03919500|Drug|Normal saline|Infants in control group are administered normal saline with the same volume and period as EPO.
15865310|NCT03919487|Procedure|Back to back colonoscopy|After first colonoscopy performing with polypectomy, the 2nd colonoscopy will be performed right after the 1st colonoscopy, and if the missed lesion during the 1st colonoscopy will be found, it should be removed.
15865311|NCT03919474|Diagnostic Test|microvascular markers|follow up of microvascular biomarkers during patient follow up
15865312|NCT03919461|Drug|Propranolol and etodolac|A perioperative combined drug regimen
15865313|NCT03919461|Other|Placebo|Placebo
15865314|NCT03919448|Biological|Bevacizumab|Single-dose infusion
15865315|NCT03919435|Drug|Trimethoprim Sulfamethoxazole|Dosage: 160mg-800mg Frequency: 2 times a day Dosage Form: Pill (oral) Duration: 4 weeks
15865316|NCT03919422|Procedure|T2 paravertebral block|Ultrasound guided T2 thoracic paravertebral block is added in ICTP group. After interscalene brachial plexus block and superficial cervical plexus block have been administrated, selective 2nd thoracic nerve root(T2) will be blocked with 10 ml of 0.25% ropivacaine(naropin).
15865317|NCT03919422|Procedure|interscalene brachial plexus block and superficial cervical plexus block|An ultrasound-guided IC block using an ultrasound machine (Sonosite, USA), and an linear array probe with a sterile cover and a 22G(Gauge) block needle is performed. An in-plane approach, advancing the needle along the longitudinal axis of the ultrasound transducer and visualizing the entire shaft is employed. Twenty ml of 0.375% ropivacaine(naropin) is injected around brachial plexus and 10 ml of 0.25% ropivacaine around superficial cervical plexus.
15865318|NCT03919409|Drug|TS-161|TS-161 capsules
15865319|NCT03919409|Drug|TS-161 Placebo|TS-161 matching placebo capsules
15865320|NCT03919396|Device|Breath-O orthokeratology lenses|"Specially designed rigid gas permeable lenses which
~reshapes corneal profile for myopia control
~has higher elasticity compared to traditional lens material."
15865321|NCT03919383|Drug|Lenvatinib|12 mg (or 8 mg) once daily (QD) oral dosing
15865322|NCT03919383|Drug|Toripalimab|240mg intravenously every 3 weeks
15865323|NCT03919370|Other|No intervention|there will be NO intervention
15865324|NCT03919357|Behavioral|BMT-i|Passing the BMT-i test
15865325|NCT03919344|Other|Critical airway closure pressure (Pcrit) measurment|Pcrit is measured in awake patient, by applying a gradually decreasing pressure through a nasal NIV mask. Pcrit is defined as the pressure inducing airflow cessation in upper airway
15865326|NCT03919344|Other|Acoustic pharyngometry|Acoustic pharyngometry will assess the volume of the pharynx and determine if there is an obstacle in the upper airways.
15865327|NCT03919344|Other|High density surface electroencephalogram neural mapping|Mapping of the respiratory neural network will allow us to study the areas of the brain activated during breathing
15865328|NCT03919331|Diagnostic Test|Assessment of tidal volume using Electrical Impedance Tomography (EIT) during high flow nasal canula(HFNC)|After information and consent, patients under HFNC for de novo acute hypoxemic respiratory failure will undergo a ten minutes 4cmH2O continuous positive airway pressure(CPAP) test while monitored with 1)chest Electrical Impedance Tomography (EIT) 2) a pneumotachograph inserted on the ventilator circuit between the mask and the Y-piece and connected to a differential pressure sensor, and 3) respiratory inductance plethysmography (RIP). Airway flow signal will be acquired using an analog/digital converter and stored for further analysis with acknowledge software. This will allow converting EIT data into tidal volume (TV), and estimating TV under HFNC. RIP signals will allow evaluating asynchronism between chest and abdomen by calculating the phase angle, thus quantifying respiratory distress. Patients monitored with an arterial catheter, arterial blood gas measurements will be done during CPAP and HFNC. These measures will be collected the first day of HFNC, and everyday up to three days
15865329|NCT03919318|Other|Root Canal Filling Sealers|Root Canal Obturation
15865332|NCT03919279|Device|active tVNS|tVNS using TENS device from Schwa-Medico (TENSeco2) + auricular electrode applied on the left ear (Schwa-Medico) + conductive gel class I; 25 Hz stimulation 1 hour daily for 1 month
15865333|NCT03919266|Procedure|Intervention: Combined use of a respiratory broad panel multiplex PCR and procalcitonin|The actions or procedures added by the research are the realization of a nasopharyngeal swab in the two strategies, and the PCT assay at D1, D3 and D7 in the pathogen-directed strategy
15865334|NCT03919266|Procedure|Control: usual antibiotic treatment|usual antibiotic treatment
15865335|NCT03919253|Combination Product|pyrotinib maleate tablets+nab-paclitaxel|pyrotinib maleate tablets: 400mg orally once daily continunously nab-paclitaxel: 125mg/m2 iv d1、8 of each 21 day cycle, 6cycles.
15865336|NCT03919240|Biological|CAR T-cell therapy|Patients enrolled will receive infusion of CD19-targeting CAR T-cells with a target dose of 5~10×10E6/kg of recipient weight, after the preparative regimen consisted of fludarabin (30mg/m2, day -5 to -3) and cyclophosphamide (300mg/m2, day -5 to -3).
15865337|NCT03919227|Procedure|empty bladder before inserting UAS|In group 1, investigator empty the bladder of urine with a catheter before inserting UAS, so that we can see if the empty bladder is easier for inserting UAS.
15865338|NCT03919227|Procedure|do not interfere with the filling degree of bladder|In group 2, investigator does not interfere with the filling degree of bladder before inserting UAS, so that we can see if the filling degree of bladder has impact on the insertion of UAS.
15865339|NCT03919214|Other|Automated Messaging|This is a 12-week prospective study with two phases. Participants will use the QardioArm device to obtain 3 separate blood pressure measurements per week (2 morning, 1 evening). The QardioArm device will only be used as a tool to gather data. In Phase 1 (Weeks 1-4), participants will self-monitor their blood pressure using the Qardio Bluetooth device. In Phase 2 (Weeks 5-12), we will implement the auto-messaging system triggered by a weekly average systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg.
15865340|NCT03919201|Other|Resistance band exercise intervention|Resistance band exercise intervention (12 weeks, 5x per week, 60 minutes per day)
15865341|NCT03919201|Other|No exercise intervention group|Control group: no exercise intervention
15865342|NCT03919188|Procedure|computer adjusted air temperature control to minimize Body Heat Loss (BHL) compared to current|Currently there are no guidelines for setting incubator parameters. The Cochrane database point out for further research (Sinclair, 2002). The investigators aim at evaluating 3 different incubator settings for the INOTHERM incubator (Mediprema, France): First parameter : computer adjusted air temperature control to minimize Body Heat Loss (BHL) compared to current
15865343|NCT03919188|Procedure|air temperature control (ATC)|Currently there are no guidelines for setting incubator parameters. The Cochrane database point out for further research (Sinclair, 2002). The investigators aim at evaluating 3 different incubator settings for the INOTHERM incubator (Mediprema, France): second parameter : air temperature control (ATC)
15865344|NCT03919188|Procedure|skin servocontrol (SSC)|Currently there are no guidelines for setting incubator parameters. The Cochrane database point out for further research (Sinclair, 2002). The investigators aim at evaluating 3 different incubator settings for the INOTHERM incubator (Mediprema, France): Third parameter : skin servocontrol (SSC).
15866280|NCT03911622|Device|MRI|medical device that is used as an imaging tool for soft tissues
15865345|NCT03919175|Drug|Umbralisib|Umbralisib is an investigational drug which blocks a protein called PI3K. PI3K is a protein that plays a role in the way cells grow. In this type of cancer, PI3K is increased and more active than usual. This helps the cancer cells to grow and survive.
15865346|NCT03919175|Drug|Rituximab|Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells
15865347|NCT03919162|Drug|PQ912|PQ912 150 mg tablets
15865348|NCT03919162|Other|Placebo|Placebo tablets to mimic PQ912 150 mg tablets
15865349|NCT03919136|Device|Wrist-worn measurement device (LiveMetric)|Evaluation of the wrist-worn measurement devices accuracy referenced to interventional (A-line) measurements.
15865350|NCT03919123|Other|Evaluation of laparoscopic promontofixation|Evaluation of Functional Outcomes and Quality of Life After Laparoscopic Promontofixation (PFL). Unicentric Retrospective Cohort Study (PeSuLife)
15865351|NCT03919110|Diagnostic Test|Collection of biological samples|"Investigators are building a collection of biological samples to perform biological assays and multiple analyses so-called omics: genomics (on the entire genome), proteomics (on all proteins) etc...This will make it possible to identify the genetic mutations or biological markers present or absent in these diseases, making it possible to confirm a diagnosis or to eliminate differential diagnoses."
15865352|NCT03919097|Other|Medical Data extraction|Data extraction from the patient's Medical Files
15865353|NCT03919084|Other|THRIVE screening and referral|The THRIVE screening tool includes questions to identify eight potentially unmet health-related social needs associated with health outcomes and healthcare utilization: housing and food insecurity, inability to afford medications, need for transportation, trouble paying for heat and electricity, need for employment or education, and difficulty taking care of children or other family members. The survey is written at a 3rd grade reading level, is available in multiple languages, and requires less than five minutes to complete. The paper screener consists of two parts: part one screens patients for health-related social needs in the eight domains. Part two asks patients to indicate the resources they want help accessing across the eight domains. Patients who request resources in one or more domains receive paper guides that describe available hospital and community resources to address the specific domain(s) indicated.
15865354|NCT03919084|Other|Pharmacy Care Program services|Pharmacy services provided by a pharmacy liaison include assessing gaps in obtaining refills, identifying barriers to medication adherence, reviewing the patient's engagement in medical care, and developing an action plan with the patient. Action plans focus on strategies to increase medication adherence and engagement in care. The pharmacy liaison will also link the patient to a clinical pharmacist, when appropriate, and will assist the patient with prescription management. After the initial intake is completed, the pharmacy liaison will call patients monthly (or meet with them prior to or following scheduled appointments) over a twelve-month period to confirm medication adherence and address any new barriers to medication adherence and engagement in medical care. The pharmacy liaison in the control arm does not systematically initiate screening for health-related social needs.
15865355|NCT03919084|Other|Patient Navigation Services|In traditional patient navigation programs, a lay person from the community guides individuals through the healthcare system to receive appropriate services. For the present study, the research team will train pharmacy liaisons (pharmacy technicians or pharmacy interns with at least a high school degree and four years of pharmacy experience) to provide patient navigation services, in addition to providing medication adherence support and assistance resolving barriers to accessing medication. In an effort to avoid duplication of services the patient navigation intervention will be delivered via a pharmacy liaison trained in patient navigation, thereby decreasing multiple intervention providers and increasing the potential for sustainability should the intervention prove effective.
15865356|NCT03919084|Other|Motivational Interviewing|Motivational interviewing is a counseling method that encourages patient-centered discussions. Motivational interviewing will be delivered by the intervention arm pharmacy liaison-patient navigators to identify the patient's unmet needs and encourage the patient to adopt behavior change that will promote engagement with resources and services to mitigate or alleviate HRSN.
15865357|NCT03919084|Other|Linkage to Community Partner Organization|The pharmacy liaison-patient navigator will partner with a community organization, Action for Boston Community Development (ABCD). ABCD will help connect patients receiving THRIVE+ to community resources including childcare, food, heating, and housing. The pharmacy liaison-patient navigator will interface directly with ABCD to coordinate receipt of resources for their patients.
15865361|NCT03919058|Other|Baseline activity (control regime)|This is a baseline measurement of physical activity during which subjects will be instructed not to change activity patterns during four days and to note all activities they perform.
15865362|NCT03919058|Other|Increased sitting time (sit regime)|Participants have to spend 14h of their day sitting, 1h walking and 1h standing, for four consecutive days. According to the compendium of Ainsworth et al. (2011), this corresponds with a daily workload of activities (DWA) of 27 metabolic equivalents (MET's) per day.
15865363|NCT03919058|Other|Non-exercise physical activity (sit less regime)|Each day (4 days in total) will consist of 3h walking, 4h standing and 9h sitting. These time frames are chosen to result in a comparable DWA increase as the exercise regime compared to the sit regime (+7 MET's)27. The additional 2h of walking and 3h of standing, compared to the sitting regime, will be done in a minimum of four bouts with a time interval of > 1h. The subjects will be instructed to walk on a slow pace. i.e. 2-3 km/h (e.g. walking during shopping and work related walking in an office).
15865364|NCT03919058|Other|Structured exercise (exercise regime)|One hour of sitting in the sit regime will be replaced with 1 training session (1h) on a cycle ergometer in the research center. The remaining hours of each day (4 days in total) have to be spent as follows: 13h sitting, 1h walking and 1h standing for daily care. The intensity of the training session (50-60% of Wmax) results in a DWA of 34.5 MET's according to the compendium of physical activities. Duration of training sessions will be adapted individually with ActivPAL data of the sit less and sit regime to identically match DWA increase between the sit less and exercise regime, compared to the sitting regime.
15865365|NCT03919045|Drug|Saline injection|Half of the patients will be randomized to saline injections into the neck and head muscles
15865366|NCT03919045|Procedure|Placebo|Half of the group will be treated with needle stings without injections
15865370|NCT03919006|Other|non surgical periodontal treatment|SRP under local anaesthesia, in a total of 2 clinical visits. Oral hygiene instructions including the modified Bass technique and an appropriate interdental cleaning device with dental floss and interdental brush.
15865371|NCT03919006|Other|Gingival crevicular fluid, saliva and serum collection|GCF with filter paper using the intracrevicular method, saliva and serum collection
15865372|NCT03918993|Drug|Tadalafil 5mg tablet|Once-a-day 5 mg dose of tadalafil for 8 weeks
15865373|NCT03918980|Drug|LOU064|LOU064 will be administered as oral capsules in parts 1 to 6.
15865374|NCT03918980|Drug|Placebo|Matching placebo capsules will be administered in parts 1,2, 4 and 6.
15865375|NCT03918967|Drug|CT-G11|oral tablet of CT-G11 Experimental Drug
15865376|NCT03918967|Drug|CT-G20|oral tablet of CT-G20 Experimental Drug
15865377|NCT03918967|Drug|CT-G11 Placebo|oral tablet of Placebo
15865378|NCT03918967|Drug|CT-G20 Placebo|oral tablet of Placebo
15865379|NCT03918954|Device|Virtual sensory room|A pair of virtual reality glasses (Oculus Go) with installed the program Calm Place, a program designed for anxiety reduction.
15865380|NCT03918954|Other|Sensory room|A room with calming elements that patients can use to feel calm.
15865381|NCT03918941|Device|Carey|mobile application
15865382|NCT03918941|Other|conventional information|leaflet, internet link and oral information
15865383|NCT03918915|Drug|SYD-101 Dose 1|Sterile topical ophthalmic solution
15865384|NCT03918915|Drug|SYD-101 Dose 2|Sterile topical ophthalmic solution
15865385|NCT03918915|Drug|Vehicle|Sterile topical ophthalmic solution without active ingredient
15865386|NCT03918902|Behavioral|Qestinnaires|Questionnaires
15865387|NCT03918889|Drug|Dexmedetomidine Injectable Product|dexmedetomidine infusion at 0.5 µg•kg-1 for 10 min before tracheotomy then adjusted to 0.3µg•kg-1•h-1
15865388|NCT03918889|Drug|Midazolam injection|midazolam infusion at 0.05 mg•kg-1 ten minutes before tracheotomy then adjusted to 0.02mg•kg-1•h-1
15865389|NCT03918863|Other|Neuromuscular electrical stimulation|Exercise protocol associated with neuromuscular electrical stimulation on vastus medialis and gluteus medius. Parameters: rectangular pulse shape, biphasic, symmetrical, pulse duration of 200μs, interbust interval of 10ms and frequency of 2.500Hz modulated in 50 bursts.
15865390|NCT03918863|Other|Exercise|Same protocol of exercises of the other group, without association of electrical stimulation.
15865391|NCT03918850|Drug|Buprenorphine Injection|Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
15865392|NCT03918850|Drug|Buprenorphine Sublingual Product|Sublingual buprenorphine (BUP-SL), administered daily.
15865393|NCT03918837|Other|Sham rTMS|Participants will undergo sham rTMS for five days with two daily fifteen minutes rTMS sessions.
15865394|NCT03918837|Other|Active rTMS|Participants will undergo active rTMS for five days with two daily fifteen minutes rTMS sessions.
15865395|NCT03918824|Other|Data extraction from medical files|Data extraction from medical files
15865396|NCT03918811|Procedure|Positive Pressure Extubation Technique|Positive-pressure extubation is performed by only one operator. Ventilator parameters are set to pressure support ventilation mode, with an inspiratory pressure of 15 cm H2O and PEEP of 10 cm H2O. Then, the cuff is deflated, and the ETT is removed without endotracheal suction. Once the ETT is removed, a suction catheter is introduced through the mouth to suction secretions drawn to the oropharynx by the air flow from the ventilator passing between the ETT and the larynx.
15865397|NCT03918811|Procedure|Traditional Extubation Technique|Traditional extubation is performed by 2 operators. Without reconnection to the ventilator, the closed suction system catheter is introduced by one of the operators into the ETT and suctioning is initiated. The cuff is immediately deflated by the other operator, and the ETT is removed with continuous endotracheal suction during the whole procedure by the first operator.
15865398|NCT03918798|Drug|Chloroprocaine 1% Injectable Solution|All the eligible patients will be administrated by Chloroprocaine 1 % according to the randomization criteria.
15865399|NCT03918798|Drug|Chloroprocaine 2% Injectable Solution|All the eligible patients will be administrated by Chloroprocaine 1 % according to the randomization criteria.
15865400|NCT03918785|Dietary Supplement|Rice germ|25 g twice a day.
15865401|NCT03918785|Dietary Supplement|Wheat-based supplement|25g twice a day.
15865402|NCT03918746|Behavioral|internet Attachment-Based Compassion Therapy (iABCT)|"The internet version of Attachment-Based Compassion Therapy (iABCT) will be developed to be totally self-applied over the Internet through the website www.psicologiaytecnologia.com designed by Labpsitec (Laboratory of Psychology and Technology, Universitat Jaume I, and University of Valencia). The iABCT will consist of eight sequential modules: Module 0) Welcome module: approaching to the compassion; Module 1) Preparing ourselves for compassion. Kind attention; Module 2) Discovering our compassionate world; Module 3) Developing our compassionate world; Module 4) Understanding our relationship with compassion; Module 5) Working on ourselves; Module 6) Understanding the importance of forgiveness; Module 7) Consolidating the practice of compassion
~The content will present through texts, audios, videos, pictures, vignettes, and interactive exercises. Downloadable PDF files will be available so that users can review them offline."
15865403|NCT03918733|Procedure|surgical treatment|surgical treatment will be done of failed root canal treated teeth
15865404|NCT03918733|Procedure|Non surgical retreatment|Non surgical retreatment will be done.
15865405|NCT03918720|Behavioral|Trekkers Family Health Empowerment Programme|Health Assessment, Health Enablement and Health Literacy provided to empower participants awareness towards a healthier life style
15865406|NCT03918707|Diagnostic Test|Rapid Whole Genome Sequencing (rWGS)|rWGS will be performed on blood samples from subjects in the prospective group in addition to standard of care laboratory testing and imaging studies. Blood samples will also be obtained from biological parents (if available), to determine if variants are inherited or de novo and for variant segregation.
15865407|NCT03918694|Dietary Supplement|Vitamin C|Daily use of Vit C tablets
15865408|NCT03918694|Dietary Supplement|Placebo|Daily use of placebo tablets
15865496|NCT03917888|Diagnostic Test|lung ultrasound|lung ultrasound will be performed daily in mechanically ventilated patients after 48 hours of ventilation to screen for ventilator associated pneumonia
15865817|NCT03915340|Drug|Propafenone|Propafenone is manufactured by Pharmtechnology LLC, Republic of Belarus. Each tablet contains 300 mg of propafenone hydrochloride.
15865409|NCT03918681|Other|Therapeutic Intervention|Instruction for all participants in the experimental group will begin with transitioning foot strike pattern from a rearfoot strike to a non-rearfoot strike running pattern (NRFS) and increasing preferred step rate by 5-10%. Each participant program thereafter will be progressed individually according to the clinical investigators follow up assessments of running mechanics and participant pain and function with running. Intervention gait retraining sessions will include drills for reinforcement to include soft landing single leg bounding, adequate time to practice, and pre-class and post-class video assessment with feedback.
15865410|NCT03918668|Behavioral|Women with recent diagnosis of breast cancer|To evaluate dietary habits of a group of women with pre and post-surgical breast cancer
15865411|NCT03918642|Behavioral|Emotional Awareness and Expression Therapy|Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.
15865412|NCT03918642|Behavioral|Cognitive Behavior Therapy|Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
15865413|NCT03918629|Biological|Clostridium difficile|Toxoid-based Clostridium difficile vaccine
15865414|NCT03918629|Biological|Placebo|Normal saline solution (0.9% sodium chloride)
15865415|NCT03918616|Drug|Memantine, Dopamine receptor-agonists|The study do not provide any experimental drugs. Patientes will receive treatment routinary used by Neurologist for these diseases.
15865416|NCT03918603|Other|ventral décubitus|Patient will have one session at least more than 12 hours between inclusion and H48 of ventral décubitus
15865417|NCT03918590|Drug|nepafenac 0.3% suspension (Ilevro; Alcon, Fort Worth, TX)|NSAID
15865418|NCT03918590|Drug|Theratears tear drop, (Akron, Ann 111 Arbor, MI)|preservative-free Artificial Tears
15865419|NCT03918590|Other|patching|no drug/ patching
15865420|NCT03918577|Other|Caloric Vestibular Stimulation|Cold water creates a convection current in the semicircular canal of the vestibular apparatus, leading to brief (<3 min) and typically well tolerated sense of rotational movement. Similar stimulation is routinely used in standard vestibular diagnostic testing.
15865421|NCT03918564|Device|Laparoscopic Gastric Vest (LGV)|"The Laparoscopic Gastric Vest (LGV), branded the ReShape Vest™, is a long-term, silastic, implantable system that is placed around the stomach to encompass the gastroesophageal junction to the Incisura Angularis.
~The main materials used to make the LGV is Implant Grade Silicone (95%) and Barium Sulfate (5%).
~The LGV is indicated for weight reduction for obese people with a Body Mass Index (BMI) between ≥35 kg/m2 and ≤55 kg/m2. It is indicated for use in adult patients (≥22 to ≤65 years) who have failed one or more conservative weight reduction alternative(s), such as supervised diet, exercise, and behavior modification program(s)."
15865422|NCT03918551|Drug|Febuxostat|Febuxostat is manufactured by Pharmtechnology LLC, Republic of Belarus. Each film-coated tablet contains 120 mg of febuxostat.
15865423|NCT03918551|Drug|Adenuric|Adenuric is manufactured by Menarini - Von Heyden GmbH, Germany (MAH: Menarini International Operations Luxembourg S.A., Luxembourg). Each film-coated tablet contains 120 mg of febuxostat.
15865424|NCT03918538|Behavioral|Home rehabilitation exercise program|After pre-test, the intervention participants received a 60 minutes of teaching regarding the home rehabilitation exercise program, with a printed exercise manual. The intervention participants also received a weekly phone call from the interventionist to enhance their exercise adherence and helping to overcome exercise barriers.
15865425|NCT03918525|Other|Sindhi families|It is an observational study and no intervention is involved
15865426|NCT03918512|Other|nine online self-administered questionnaires|"patients will be invited to complete the following nine online self-administered questionnaires at baseline, 7 days and 3 months:
~Demographical and clinical characteristics at baseline
~Consolidated version of the CSS-48 questionnaire
~Lumbar pain numeric rating scale (NRS)
~Radicular pain NRS
~Zurich Claudication Questionnaire (ZCQ) (physical function subscale)
~Oswestry Disability Index (ODI)
~Fukushima LSS Scale 25 (FLS-25)
~12-Item Short Form Health Survey (SF-12)
~Anchoring questions : 1 anchoring question about patient acceptable symptom state (at baseline, 7 days and 3 month) and 1 anchoring question about patient minimal clinically important difference (at 3 months)."
15865427|NCT03918499|Drug|Cyclophosphamide|Given IV
15865428|NCT03918499|Biological|Cytokine-based Biologic Agent IRX-2|Given SC
15865429|NCT03918499|Biological|Pembrolizumab|Given IV
15865430|NCT03918486|Device|Caretaker|Application of Caretaker device to subjects that are scheduled for elective surgeries.
15865431|NCT03918473|Other|Mobilization with Movement|The MWM group will receive manual therapy with the following protocol: the participant will be relaxed and standing in a staggered stance with the involved foot on an eight-inch step and both feet facing forward. The clinician will be positioned in front of the participant's leg and a non-elastic belt will be placed around the distal leg of the participant and the clinician's pelvis. The clinician will then apply a sustained posteroanterior glide to the tibia through the belt by leaning backwards, while stabilizing the fixed talus and forefoot with both hands. The participant will perform a slow lunge until the end range of motion without their heel lifting off the ground. The belt will be kept perpendicular to the tibia throughout the movement and 2 sets of 10 repetitions will be applied.
15865432|NCT03918473|Other|Thrust Mobilization|The talocrural joint TM will be a high velocity low amplitude manual therapy technique. This technique will be applied with the participant in the supine position on a plinth. The clinician grasps the foot with one hand with the fifth finger contacting the anterior surface of the ankle at the talus. The other hand reinforces the contact points and both thumbs are placed on the sole of the participant's foot. The clinician gives slight caudal traction focused on the talocrural joint with the ankle dorsiflexed and everted. The therapist then applies a high-velocity thrust distraction technique to the talocrural joint. Only one thrust will be applied and no audible cavitation is required. This manual therapy technique will be performed once.
15865433|NCT03918460|Device|ANEUFIX|ANEUFIX is administered through translumbar injection into the AAA using imaging techniques to guide the place of injection.
15865434|NCT03918447|Drug|Bardoxolone methyl oral capsule|Bardoxolone methyl capsules dose escalated from 5 mg to a maximum of 20 or 30 mg, depending on baseline proteinuria status.
15865435|NCT03918447|Drug|Placebo oral capsule|Capsule containing an inert placebo
15865553|NCT03917420|Drug|Emtricitabine 200 MG|Once daily dose of the combo tab x 5 days pre-sampling
15865436|NCT03918421|Other|Clinical examination and patients' questionnaires regarding activity and participation (preliminary Immunogloblin M (IgM)-Rasch-built overall Disability Scale (RODS), and finalized IgM-RODS)|Rasch-built overall Disability Scale (RODS) is a disease-specific, patient-based, linearly weighted scale that captures activity and social participation limitations to detect activity limitations in patients with Immunogloblin M (IgM) anti-myelin-associated-glycoprotein peripheral neuropathy. For this study, the preliminary RODS is a 146 item patient-reported outcome instrument that assesses activity and social participation limitation. Rasch Measurement Methods examine the extent observed data (patients' actual responses to scale items) accord with predictions of those responses from a mathematical model.
15865437|NCT03918408|Combination Product|PXL-330 Platinum device for crosslinking with Peschke ribofflavin solution|Riboflavin will be used to load the cornea, followed by UV-A crosslinking of the cornea
15865438|NCT03918395|Dietary Supplement|Placebo beverage|A placebo beverage will be consumed both post-exercise and pre-bed
15865439|NCT03918395|Dietary Supplement|Protein-polyphenol beverage|A protein-polyphenol beverage will be consumed both post-exercise and pre-bed
15865440|NCT03918382|Other|Electronic Patient-Reported Outcome|Weekly reporting of patient-reported outcomes on a tablet for closer contact between patient and clinic during radiotherapy.
15865441|NCT03918369|Procedure|Laparoscopic right hemicolectomy with intracorporeal anastomosis.|Intracorporeal anastomosis group The laparoscopic right hemicolectomy with intracorporeal mechanical side-to-side isoperistaltic anastomosis. In this procedure, intracorporeal division of the mesoileum and transverse colon is performed, as shown in the animation. The ileum and transverse colon are divided with the Endopath® Echelon Flex ™ 60 stapler. The specimen is inserted in a plastic bag. Side-to-side isoperistaltic mechanical anastomosis is performed using the same endostapler. A running suture is performed of the mechanical suture orifice, with another reinforcing suture with Monocryl ™ (poliglecaprone 25) or with STRATAFIX ™ Spiral Knotless barbed suture. The specimen is extracted through a Pfannestiel minilaparotomy (3.5-4 cm) Wound Protector
15865442|NCT03918369|Procedure|Laparoscopic right hemicolectomy with extracorporeal anastomosis.|Laparoscopic right hemicolectomy with extracorporeal anastomosis with the technical features of each center
15865443|NCT03918356|Device|electrical impedance myography|Electrical impedance myography (EIM) is a new electrodiagnostic method of quantitative muscle evaluation. It utilizes concepts of bio impedance, the ability of biological tissue to impede externally applied electrical current.
15865444|NCT03918356|Other|healthy control group|healthy control
15865445|NCT03918343|Other|Blood sample|blood samples (4 times; 14ml per visit)
15865446|NCT03918317|Device|AirXpanders AeroFormtissue expander|The AeroFormdevice will be placed in an immediate fashion at the time of mastectomy in a submuscular, prepectoral or dual-plane approach. The tissue expander will be minimally inflated intraoperatively to minimize dead space and while facilitating tension free closure. Participants will undergo standard postoperative management, and will be given instructions on utilization of the device, including daily expansion until desired volume is reached as determined b surgeon and participant agreement.
15865447|NCT03918291|Other|Addition of whole-body vibration to squat training|
15865448|NCT03918291|Other|Squat training|squatting exercises for 12 weeks, 3x/week
15865456|NCT03918265|Drug|Tacrolimus|On refractory autoimmune cytopenia patients, tacrolimus was tried. Dosage: 1mg bid and tacrolimus trough targets were 5-10 ng/ml throughout the study
15865457|NCT03918252|Drug|Nivolumab Injection|Receive preoperative nivolumab, 240mg IV, on Day -42, -28 and Day -14 (+/- two days for each timepoint) prior to planned surgery on Day 0 (to allow for scheduling surgery may take place between Day -3 and Day +10).
15865458|NCT03918252|Drug|Ipilimumab Injection|Receive preoperative nivolumab, 3mg/kg IV, on Day -42, -28 and Day -14 (+/- two days for each timepoint) + ipilimumab 1mg/kg IV on Day -42 prior to planned surgery on Day 0 (to allow for scheduling surgery may take place between Day -3 and Day +10).
15865459|NCT03918239|Drug|SHP643|Participants will receive injection of SHP643.
15865460|NCT03918226|Procedure|exploratory laparotomy|Patients presenting with acute abdomen were operated. Exploratory Laparotomy of patients was done. Further procedure was done according to peroperative findings. Ileostomy for perforation of gut, stricturoplasty for strictutre, biopsy for mesentric lymphadenopathy
15865461|NCT03918213|Diagnostic Test|High-Resolution anorectal manometry with the use of solid-state catheter|High resolution anorectal manometry with the use of solid-state catheter will be performed to eligible subjects willing to participate in the study
15865462|NCT03918200|Other|Serum amyloid A level|For determination of SAA level, a 5-ml sample of venous blood will be taken from each participant under aseptic conditions, and centrifuged at 2500 g for 15 minutes at 4°C c. separated into serum aliquots,and stored frozen at -80°C until analysis of SAA ,which will be done by a double-antibody sandwich Enzyme Linked Immunosorbent Assay (ELISA) kits supplied by cusabio,USA according to manufacturers instruction .Each sample was tested in duplicate and the average will be taken. A cut off level of 30 mg/L SAA level will be chosen to reflect a real increase in its level
15865463|NCT03918187|Drug|Bupivacaine|compare between nalbuphine versus midazolam as an adjuvant to intrathecal bupivacain to evaluate postoperative analgesia .
15865464|NCT03918187|Drug|Nalbuphine|compare between nalbuphine versus midazolam as an adjuvant to intrathecal bupivacain to evaluate postoperative analgesia .
15865465|NCT03918187|Drug|Midazolam|compare between nalbuphine versus midazolam as an adjuvant to intrathecal bupivacain to evaluate postoperative analgesia .
15865466|NCT03918174|Device|Dart splint orthosis|The Dart Splint orthosis was fitted to the subjects in the research group on their first evaluation session. They received oral and written instructions regarding the donning and manner of exercise. Specifically, they were instructed to use the Dart splint orthosis at home. For each 10-minute exercise session, they were asked to perform 5 minutes of radial-extension under resistance and then 5 minutes ulnar-flexion under resistance. In addition, this group was required to fill in a chart at the end of each practice session (morning, noon and evening), throughout the intervention period.
15865467|NCT03918174|Other|Conventional treatment|The control group activated the wrist mostly in the sagittal plane. This group was instructed to perform at home active wrist motion similar to that practiced during the supervised therapy sessions. The prescribed instructions were similar to the exercises performed during the sessions. Specifically, they were instructed to exercise at home for 10-minute in each session, three times a day (morning, noon and evening), throughout the intervention period.
15865468|NCT03918161|Device|MRE exam|Magnetic Resonance Elastography
15865469|NCT03918148|Drug|SGLT-2i|Dapagliflozin or canagliflozin or empagliflozin add on to metformin ± basal insulin
15865470|NCT03918148|Drug|DPP-4i|Sitagliptin or vildagliptin or saxagliptin or linagliptin or alogliptin add on to metformin ± basal insulin
15865471|NCT03918135|Drug|Paracetamol|"1000 mg of paracetamol (parol 10mg/ml Mefar, Turkey) intravenous (IV) was given 100 patients
~Other Names:
~Perfalgan
~Paracerol"
15865472|NCT03918135|Drug|Ibuprofen|"400mg of ibuprofen(intrafen 400mg/4ml Gen ilaç sanayi, Turkey) intravenous (IV) was given 100 patients
~Other Names:
~Dorifen"
15865473|NCT03918122|Other|Self-Assessment via pre and post survey|Master Preceptor Fellows will assess and evaluation professional development, knowledge, clinical practices and master preceptor knowledge before the Master Preceptor Fellowship and After completion of the Master Preceptor Fellowship
15865474|NCT03918109|Drug|OTO-313|single intratympanic injection of gacyclidine
15865475|NCT03918109|Drug|Placebo|single intratympanic injection of placebo
15865476|NCT03918096|Other|Questionnaire|Questionnaire to the parents after the hospital discharge
15865477|NCT03918083|Behavioral|Wellness|Assess the feasibility of an integrated, prescriptive, and trackable wellness intervention amongst residents at Orange Park Medical Center (OPMC) by combining five wellness elements including: exercise, mindfulness, sleep, social connectedness, and nutrition.
15865478|NCT03918070|Device|Yukon Choice PC and Yukon Chrome PC|The Yukon Choice PC & the Yukon Chrome PC Sirolimus Eluting Bioabsorbable Polymer Coronary Stent Systems are indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease.
15865479|NCT03918057|Behavioral|Cognitive Behavioural Therapy for Insomnia|Cognitive behavioural therapy for insomnia (CBT-I) is an evidence-based psychotherapeutic intervention that combines cognitive and behavioural principles. Specifically, this therapy provides psychoeducation about thoughts contributing to the maintenance of sleep problems, and instruction in behavioural techniques to help decrease sleep onset latency and promote effective sleep maintenance.
15865480|NCT03918057|Other|Active Control|Participants will receive regular obstetric care and will be placed on a wait-list for CBT-I treatment after their final assessment. All activities women try for improving their own sleep problems between assessments will be recorded and coded for.
15865481|NCT03918031|Behavioral|PFI for Smoking & Distress Tolerance|Personalized Feedback Intervention for smoking and distress tolerance.
15865482|NCT03918031|Behavioral|PFI for Smoking Only|Personalized Feedback Intervention for smoking only (no distress tolerance component)
15865483|NCT03918018|Device|BORA Band SpO2 Validation Study|"Qualified healthy volunteers will be enrolled into the study. Subjects will recline for the study. Reference sensor(s) will be placed on each subject to evaluate the SpO2 accuracy and performance. Shield material may be used between any adjacent finger sensors to prevent optical crosstalk.
~Simultaneous data collection will be set up for device under test and the control pulse oximeter. The data from the test device will be collected by the sponsor or trained Clinimark Study staff. Data will be collected for 1 second intervals data analysis. The SpO2 accuracy of the test devices will be evaluated over the oxygen saturation range between 70-100%.
~The investigational device will only be placed on the wrist. The control pulse oximeter may be alternated through fingers between subjects."
15865484|NCT03918005|Other|Low glycemic load diet|Foods with low glycemic index or glycemic load (brown rice, brown bread, whole wheat pasta, oat bran, yogurt, milk, apple, pear, peach)
15865485|NCT03917979|Behavioral|Individual GIM|Participants are provided with a series of 10 individual GIM sessions, scheduled once every two weeks. Frequency may change if clinically indicated. Individual GIM sessions begin with a discussion of important issues related to the client's life and symptoms, forming a focus for the session. Then, the therapist provides suggestions to help the client become highly relaxed and focused in preparation for the music-listening portion of the session. The therapist plays specially-selected music from the Western classical tradition to match the client and the focus for the session, and engages in verbal dialogue with the client to help them explore their own internal imagery while listening to the music. After the music ends, the therapist and client engage in discussion about their imagery in metaphoric connection to their therapeutic process. This may include arts-based approaches to process the session. Sessions last approximately 90-120 minutes.
15865486|NCT03917979|Behavioral|Waitlist Control|Participants complete an initial wait list period of 26 weeks, equivalent to the treatment and 6-week follow-up period for the experimental arm. They are then provided with four Group GIM sessions scheduled once per week. Group GIM sessions start with a group discussion about events or feelings from the week and issues related to depression and wellbeing. Then the therapist provides suggests to help the clients relax and focus in preparation for the music-listening period. Group members will explore a theme or issue related to therapy while focusing on whatever comes to them as the music is played. After the music, there will be a time to work with the imagery experienced during the music. This may be in the form of discussion or other art forms. The session ends with a discussion about gains and insights from the music and imagery. Sessions last 90-120 minutes.
15865487|NCT03917966|Drug|SHR-1210+docetaxel+nedaplatin|neoadjuvant chemotherapy:SHR-1210, 200mg,q2w, a total of 3 times; docetaxel 75mg/m2 ivgtt d1, nedaplatin 75mg/m2 ivgtt d1, q3w, for 2 cycles.The patient was evaluated after 2 cycles of neoadjuvant chemotherapy. The surgery was performed 3-4 weeks after the completion of neoadjuvant chemotherapy.
15865488|NCT03917953|Device|Transcutaneous Electrical Acupoint Stimulation|"Patients in the experimental group will be treated for 20 min TEAS, twice a week, for a total of 4 weeks of treatment.The same intervention was performed in the sham group (electrode patches were attached at corresponding acupoints without electrical stimulation).
~Acupoint selection: baihui (GV 20), taichong (LR 3), taixi (KI 3)."
15865489|NCT03917940|Dietary Supplement|Omega 3 fatty acids 1000 mg per day + glimepiride 2 mg or 3 mg oral|Omega 3 fatty acids 1000 mg per day oral
15865490|NCT03917940|Drug|Glimepiride|glimepiride 2 mg or 3 mg per day oral
15865491|NCT03917927|Device|Eztetic dental implant|narrow diameter dental implant
15865492|NCT03917914|Drug|Bisoprolol|As in arm description
15865497|NCT03917875|Behavioral|Personalized feedback intervention|The novel integrated PFI will be developed and modeled from past PFIs targeting hazardous drinking. Participants will view feedback on the computer screen. The computer program/algorithm will determine the proper normative feedback to participants.
15865498|NCT03917862|Combination Product|TDM-621|The TDM-621 is a topic hemostatic product which will be used during ascending aortic surgery.
15865499|NCT03917849|Behavioral|Exercises program for patellar tendinopathy|To compare the effectiveness of the inertial flywheel resistance program versus slow heavy resistance in patients with chronic patellar tendinopathy
15865500|NCT03917836|Diagnostic Test|endoscopy and histology|diagnostic evaluation of chronic gastritis
15865501|NCT03917823|Device|Cryoneurolysis|The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation separated by 1-minute defrost periods for the target intercostal nerves.
15865502|NCT03917823|Device|Sham comparator|For the sham probes, the nitrous oxide will be vented prior to reaching the probe shaft, resulting in a lack of perineural temperature change.
15865503|NCT03917810|Other|Diet|Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated
15865504|NCT03917797|Biological|MSC treatment|Umbilical cord-derived Mesenchymal Stromal Cell
15865505|NCT03917797|Drug|Standard of Care|Methylprednisolone; Cyclophosphamide; Prednisone; Mycophenolate
15865506|NCT03917797|Drug|Placebo|MSC infusion vehicle
15865507|NCT03917784|Drug|Curcumin|Oral supplementation with curcumin 500 mg oral dosing for 3 months
15865508|NCT03917784|Drug|Starch|Oral supplementation with starch 500 mg oral dosing for 3 months
15865509|NCT03917771|Other|Early lymphedema detection|Face-to-face consultation in Rehabilitation for early detection of lymphedema after surgery (1,6,12 months). Lower Limb measurement and care education
15865510|NCT03917771|Other|Usual follow-up|Usual follow-up carried out in GO consultation
15865511|NCT03917758|Drug|SGLT2 inhibitor|Start of the treatment with SGLT2i.
15865512|NCT03917745|Behavioral|eHealth mindfulness intervention|The web-based intervention consists of eight sessions including psycho-education about the mechanisms of stress, coping and relaxation, especially related to pregnancy, practicing mindfulness skills (i.e. mindful breathing, mindful moving, observing and letting-go of thoughts and emotions with a non-judgmental attitude), sharing experiences, and doing home assignments. The sessions have been developed specifically for pregnant women and acknowledge pregnancy-related distress. An online coach will review questions and home assignments of the participants. Women will start the training at 16 weeks gestation.
15865513|NCT03917732|Behavioral|cognitive training|"The cognitive training the investigators are planning consists of three modules which, in their entirety, are intended to help improve bladder dysfunction, which leads to psychological distress in patients: psychoeducation, training of cognitive functions and training in behavioural therapeutic techniques.
~The training will take place over six weeks, with two sessions per week in the first three weeks. In the following three weeks the frequency will be reduced to once a week so that there will be 9 sessions. The duration of each training session is 90 minutes."
15865514|NCT03917732|Behavioral|pelvic floor training|"At the beginning of the training, perception of the pelvic floor is the most important factor. The patients should learn the motor skills to consciously perceive and feel the pelvic floor muscles. This requires a lot of concentration and movement control. After this perception phase, the learned movements are internalized. The fine coordination of the pelvic floor muscles is more harmonious and the tensing and relaxing of the muscles becomes easier over time. In the last phase of the training, the movements and muscle activations should be internalised in such a way that they are anchored as automated movement patterns.
~The training will take place over six weeks, with two sessions per week in the first three weeks. In the following three weeks the frequency will be reduced to once a week so that there will be 9 sessions. The duration of each training session is 90 minutes."
15865515|NCT03917719|Drug|Edasalonexent|100 mg/kg/day
15865516|NCT03917706|Other|Questionnaire|Patients will be contacted by phone in order to fill in a questionnaire regarding their quality of life.
15865517|NCT03917693|Dietary Supplement|Phytin, rice extract|Consumption of a rice extract, called phytin for a period of 2 weeks
15865518|NCT03917693|Other|MCC, placebo|Consumption of MCC, a placebo, for a period of 2 week
15865519|NCT03917680|Diagnostic Test|Factor XII dosage|Factor XII (FXII, Hageman factor) will be measured in plasma. It is converted to FXIIa by an activator. The FXIIa protease cleaves a chromogenic substrate and releases p-nitroaniline (pNA), which can be measured photometrically.
15865520|NCT03917680|Genetic|p.Thr328Lys mutation detection|Sequencing of exon 9 of franking introns of FXII, for identification of the p.Thr328Lys mutation.
15865521|NCT03917680|Diagnostic Test|Videocapillaroscopy|It is an optical method to visualize the most superficial part of the cutaneous microcirculatory network. It provides morphological information.
15865522|NCT03917667|Diagnostic Test|EWGSOP2|EWGSOP2 criteria (Writing Group for the European Working Group on Sarcopenia in Older People 2) will be followed to determine the diagnosis of sarcopenia, considered as a dichotomous variable -yes/no- in presence of low grip strength + low muscle mass + low gait speed.
15865523|NCT03917654|Biological|Pfs230D1M-EPA/AS01|Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM phosphate-buffered saline (PBS) to a 2x dilution of the high dose (160 micrograms/mL in cGMP compliance at Walter Reed Bioproduction facility in April 2016 and will be provided as a single use vial. AS01B adjuvant was manufactured for use in the SHINGRIX vaccine by G
15865524|NCT03917654|Biological|HAVRIX|HAVRIX (Hepatitis A Vaccine; HAV) is produced by GSK and is a sterile suspension of inactivated virus for IM administration. The virus (strain HM175) is propagated in MRC-5 human diploid cells. HAVRIX is FDA approved for active immunization against disease caused by HAV for persons 12 months of age and older.
15865525|NCT03917654|Biological|TYPHIM Vi (Salmonella typhi vaccine)|TYPHIM Vi (Typhoid Vi Polysaccharide Vaccine), produced by Sanofi Pasteur SA, for IM use, is a sterile solution containing the cell surface Vi polysaccharide extracted from Salmonella enterica serovar Typhi, S typhi Ty2 strain (inactivated, subunit vaccine). TYPHIM Vi vaccine is indicated for active immunization for the prevention of typhoid fever caused by S typhi and is FDA approved for use in persons 2 years of age or older
15865580|NCT03917160|Device|EMS device|EMS treatment will be performed
15865818|NCT03915340|Drug|Rytmonorm|Rytmonorm is manufactured by Famar Lyon, France (MAH: Mylan Healthcare GmbH, Germany). Each tablet contains 300 mg of propafenone hydrochloride.
15865526|NCT03917654|Biological|Menactra|Menactra (Sanofi Pasteur) is a sterile, intramuscularly administered vaccine that contains Neisseria meningitidis serogroup A, C, Y, and W-135 capsular polysaccharide antigens individually conjugated to diphtheria toxoid protein. No preservative or adjuvant is added during the manufacturing process. Menactra is FDA approved for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 (but does not protect against serotype B) for use in individuals 9 months through 55 years of age.
15865527|NCT03917654|Biological|AVAXIM|AVAXIM (Registered Trademark) - Pediatric [Hepatitis A Vaccine Inactivated] is a sterile, whitish, cloudy suspension. The active ingredient is a purified and formaldehyde-inactivated hepatitis A virus (HAV) obtained from the GBM strain, cultured on MRC-5 human diploid cells. HAV is adsorbed onto aluminum. (Delta)
15865528|NCT03917641|Biological|Khat leaves|One of the two compressions (one per each eye) the patient will use will contain the Khat leaves.
15865529|NCT03917628|Drug|SCT630|SCT630 single s.c. injection
15865530|NCT03917628|Drug|adalimumab-EU source|adalimumab-EU source single s.c. injection
15865531|NCT03917615|Other|pelvic floor contraction|Ultrasound examination will be performed to asses urinary bladder displacement being a marker for pelvic floor muscle function
15865532|NCT03917602|Procedure|human amniotic membrane plug with vitrectomy|using human amniotic membrane plug with vitrectomy to try to close large macular hole
15865533|NCT03917576|Other|Behavioral|The resting heart rate (HRrest), maximum HR (HRmax), HR recovery (HRRTEST), delta HR recovery (ΔHRRTEST) were measured by continuous telemetric heart rate sensor (Polar FT4, PolarTM, Finland) during an incremental exercise test designed to obtain maximum oxygen consumption (VO2max) on a cycle ergometer (Lode Corival, Groningen, The Netherlands) similar with previous studies using similar cohort. An indirect calorimetry/ergospirometry system (Ultima CPXTM metabolic system, Medgraphics, Minnesota, USA) was used to measure VO2max until volitional exhaustion. Thus, the modified Astrand volitional protocol was applied in the participants of all NG, Pre-T2D and T2D groups increasing the load (i.e., Watts) 25 W each 2 min to women, and 50 W each 2 min to men.
15865534|NCT03917576|Other|Exercise training intervention|Subjects also participated in a single HIIT session composed of 10-cycling intervals, using a Lode Corival cycle ergometer. The exercise session consisted of 1-minute cycling at high intensity (workload during each interval was set at ~80-100 % maximal power achieved during the incremental exercise test with a workload that allowed to work until the volitional muscle failure in 1-minute), followed by 2-minutes of inactive resting period (sitting still on the cycle ergometer), and was repeated 10 times (1x2x10 protocol; 1:2:10 to work:rest:repetitions respectively).
15865535|NCT03917563|Device|WATCHMAN LAA occluder|WATCHMAN LAA occluder
15865536|NCT03917550|Behavioral|Recovery (Transdiagnostic & self)|This transdiagnostic program is based on the general Cognitive Behavioral Therapy (CBT) principles and targets core higher order factors such as negative affectivity and emotion dysregulation, using common intervention techniques applicable across disorders. The program was designed to directly address the aversive emotional experiences often reported by clients, hoping to reverse participants' maladaptive thinking style and dysfunctional behaviors. In addition, specific intervention designed to improve self-compassion, unconditional self-acceptance, self-esteem and self concept clarity were added.
15865537|NCT03917550|Behavioral|Transdiagnostic|This transdiagnostic program is based on the general Cognitive Behavioral Therapy (CBT) principles and targets core higher order factors such as negative affectivity and emotion dysregulation, using common intervention techniques applicable across disorders. The program was designed to directly address the aversive emotional experiences often reported by clients, hoping to reverse participants' maladaptive thinking style and dysfunctional behaviors.
15865538|NCT03917537|Genetic|HNSCC patients have used Nivolumab|Using Whole-Genome Analysis on Cancer Tissue of Patients with Platinum-refractory Head and Neck Squamous cell carcinoma Who Underwent Nivolumab to Precisely Predict Responders: An Observational Biomarker Study
15865539|NCT03917511|Behavioral|Robotic training with mirror therapy|Participants will receive 18 intervention sessions for about 6 consecutive weeks in a clinical setting (1 hour per session, 3 sessions per week). For each intervention session, participants will first receive 20 minutes mirror therapy followed by 40 minutes robotic-assisted training (robotic-assisted training includes 10 minutes active/passive training mode and 30 minutes robot-participant interactive training mode).
15865540|NCT03917511|Behavioral|Robotic-assisted training|The training procedure will be the same as the robotic-assisted training with mirror therapy group except that sham mirror therapy will be provided in the first 20 minutes in the intervention session.
15865541|NCT03917498|Radiation|Single Pre-Operative Radiation Therapy - with Delayed Surgery|Single Pre-Operative Radiation Therapy - with Delayed Surgery
15865542|NCT03917472|Drug|Brolucizumab|Intravitreal injection
15865543|NCT03917472|Drug|Aflibercept|Intravitreal injection
15865544|NCT03917459|Drug|LCZ696|LCZ696 50 mg = 24 mg/26 mg bid sacubitril/valsartan; 100 mg= 49 mg/51 mg bid sacubitril/valsartan or 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tablets
15865545|NCT03917459|Drug|Enalapril matching placebo|Placebo to Enalapril 2.5 mg, 5 mg and 10 mg film-coated tablets
15865546|NCT03917459|Drug|Enalapril|Enalapril 2.5 mg, 5 mg and 10 mg film-coated tablets
15865547|NCT03917459|Drug|LCZ696 matching placebo|Placebo to LCZ696 50 mg = 24 mg/26 mg bid sacubitril/valsartan; 100 mg= 49 mg/51 mg bid sacubitril/valsartan or 200 mg = 97 mg/103 mg bid sacubitril/valsartan film-coated tabletsLCZ696 50 mg, 100 mg and 200 mg
15865548|NCT03917446|Drug|Propofol bolus|Each patient gets propofol bolus in three doses. 0.25 mg/kg, 0.5 mg/kg and 1 mg/kg. After each dose patient's blood pressure, heart rate and haemodynamic values calibrated with PICCO device (cardiac output, cardiac index, stroke index, stroke volume, stroke volume variation, dPmax) are recorded in 15 seconds intervals for 10 minutes.
15865549|NCT03917433|Behavioral|Virtual Reality Exposure Therapy|Participant completes virtual reality exposure therapy for acrophobia involving walking across a plank at higher and higher levels in a virtual city environment.
15865550|NCT03917433|Behavioral|Tactile Feedback|In the real world, the participant walks across an actual wooden plank on the floor, which mirrors the plank in the virtual world.
15865551|NCT03917433|Behavioral|Point-based Rewards|Participant has the opportunity to pop balloons upon reaching the ends of the plank to gain points. Participant's popping instrument in the virtual world upgrades as more points are accumulated.
15865552|NCT03917420|Drug|Tenofovir 300Mg Oral Tablet|Once daily dose of the combo tab x 5 days pre-sampling
15865554|NCT03917407|Drug|DUR-928 (Moderate AH)|"A total of no more than two doses of DUR-928 will be given, with 72 hrs between each dose. A second dose of the assigned study treatment (test drug) will be repeated 3 days after Dose 1 to patients who are still hospitalized. If a patient meets the discharge criteria prior to Day 4, the patient will receive only one dose of DUR 928.
~Patients of Part A (MELD 11-20) will follow the dose escalation procedure based on cohort; each patient will receive an intravenous infusion dose of:
~Cohort 1A: 30 mg of DUR-928in 100 mL 5% dextrose or 0.9% sodium chloride administered over approximately 2 hrs via IV infusion.
~Cohort 2A: 90 mg of DUR 928 in 100 mL5% dextrose or 0.9% sodium chloride administered over approximately 2 hrs via IV infusion.
~Cohort 3A: 150 mg of DUR 928 in 100 mL5% dextrose or 0.9% sodium chloride administered over approximately 2 hrs via IV infusion."
15865555|NCT03917407|Drug|DUR-928 (Severe AH)|"Dose escalation to the next cohort will be determined after review of safety, tolerability and pharmacokinetic data of the previous cohort. Dose escalation for Part B will follow the same requirements as for Part A. The dose levels for Part B are planned to be the same as Part A.
~Patients of Part B (MELD 21-30) will follow the dose escalation procedure based on cohort; each patient will receive an intravenous infusion dose of:
~Cohort 1B: 30 mg of DUR-928 in 100 mL 5% dextrose or 0.9% sodium chloride administered over approximately 2 hrs via IV infusion.
~Cohort 2B: 90 mg of DUR 928 in 100 mL5% dextrose or 0.9% sodium chloride administered over approximately 2 hrs via IV infusion.
~Cohort 3B: 150 mg of DUR 928 in 100 mL5% dextrose or 0.9% sodium chloride administered over approximately 2 hrs via IV infusion More details on preparation and administration of study drug will be provided in the Investigation Product Manual for this study."
15865556|NCT03917394|Drug|rHuEPO|rHuEPO was administrated daily with 10000 IU or 20000 IU
15865557|NCT03917394|Drug|Iron sucrose|Iron sucrose was administrated daily with 100mg or 200mg
15865560|NCT03917368|Other|Ultrasound scan of the internal jugular veins|Participants, lying at their hospital bed, will maintain their head in a fixed position on the longitudinal axis, while an operator gently places a linear probe L12-RS (7.5-11 MHz), smeared with gel, on one side of the neck, at the middle level. A 15-sec video clip of the ultrasound images will be recorded. This procedure will be repeated on the other side of the neck. In addition, three electrodes will be placed on participants' chests and connected to the ultrasound system for simultaneously measuring the ECG signal.
15865561|NCT03917355|Behavioral|Nonverbal synchrony, therapeutic alliance|Association between motor synchronisation in psychiatrist/patient dyad and patient therapeutic adherence in patients with a first psychotic episode will be measured, 6 months after the first post hospitalisation consultation, using video without sound. Nonverbal synchrony, therapeutic alliance and treatment will evaluated.In this purpose, videos of patients and psychiatrist will be made (for all patients included), and the images will be analyzed.
15865562|NCT03917342|Device|EEG measure|Frontal 3-derivation EEG measure under different conditions in pregnancy (healthy vs preeclampsia) and baseline non-pregnant women
15865563|NCT03917329|Other|ACT and PBS group workshop|Acceptance and Commitment Therapy and Positive Behaviour Support Group Workshop. Three sessions of approximately three hour duration. Groups will consist of 5-10 parents or 5-10 members of education staff. The group will include both didactic and experiential elements.
15865564|NCT03917316|Other|Language and neuropsychological tests|Tests related to language, narrative and specific and general cognitive function
15865565|NCT03917303|Drug|Adalimumab|episodic treatment with subcutaneous adalimumab for 6 months
15865566|NCT03917303|Drug|standard step-up care|conventional step-up care starting with corticosteroids
15865567|NCT03917290|Behavioral|Neuromuscular training|Training will be conducted with a research assistant under the supervision of Dr. Howell (PI), a certified athletic trainer, who will meet with participants either at the individual or small group level (3-4 participants maximum). Training will be done within the Children's Hospital Colorado network-of-care locations, dependent on the location of participants. Due to in-person restrictions that have resulted from COVID-19, participants may also complete the intervention via remote (virtual) training sessions.
15865568|NCT03917277|Device|Musculoskeletal ultrasound|"Ankle sonographic examination will be performed using Samsung UGEO H60 ultrasound machine in use since 2016. In order to optimize reproducibility, all examinations will be performed by a single examiner. Multiplanar (longitudinal/transverse) scanning will be done in B- and PD-mode to identify pathologies defined by the OMERACT network in the following structures:
~Talocrural joint:synovial fluid (scored 0-3);synovitis with synovial hypertrophy and PD signal (each scored 0-3); bone erosion with distance between cortices and presence/absence of DP signal
~Tibialis anterior,tibialis posterior, extensor digitorum longus, fibularis brevis,fibularis tertius,and calcaneal tendons: presence/absence of tenosynovitis, thickening, hypoechogenicity, nodularity, fusiform aspect, and DP signal
~Calcaneal enthesis: presence/absence of thickening,hypoechogenicity,calcification, cortical irregularity,and DP signal
~Retrocalcaneal and calcaneal bursa: presence/absence of bursitis and DP signal"
15865569|NCT03917264|Procedure|Peri-implantitis debridement|Mechanical cleaning of titanium implants, peri-implantitis debridement.
15865570|NCT03917264|Other|Dental hygiene procedures|Titanium scalers and nylon brushed used for implant cleaning
15865571|NCT03917251|Diagnostic Test|Coronary flow and pressure measurement in patients with ventricular pacing|Coronary flow and pressure measurement in patients with ventricular pacing
15865572|NCT03917238|Radiation|gallium-68-exendin injection followed by PET/CT scan|After injecting gallium-68-exendin, a PET/CT scan is performed during the honeymoon phase and repeated once the honeymoon phase has ended
15865573|NCT03917225|Drug|MIN-102|Once-daily dosing with a volume specified by the pharmacokineteic specialistto achive the desired plasma exposure. Min-102 Oral suspension, strength 15mg/ml.
15865574|NCT03917225|Drug|Placebo|Once-daily dosing with a volume specified by the pharmacokinetic specialist. Oral Suspension.
15865575|NCT03917212|Other|No intervention|No intervention, observational study with metabolic characterisation
15865576|NCT03917186|Drug|Sevoflurane|administration of sevoflurane
15865577|NCT03917186|Drug|Desflurane|administration of Desflurane
15865578|NCT03917173|Procedure|Surgery plus HIPEC CO2|Prophylactic surgery plus HIPEC CO2 performed with mitomycin and cisplatin v
15865579|NCT03917173|Procedure|Standard surgery|Standard surgery without HIPEC CO2
15865581|NCT03917147|Procedure|Office Hysteroscopy|Patients underwent office hysteroscopy with a 5-mm continuous-flow hysteroscope and endometrial biopsies were taken using miniaturized instruments. Histopathological examination was conducted to confirm the diagnosis.
15865582|NCT03917134|Drug|cephalosporin + Metronidazole Vaginal|administration of cephalosporin in doses of 2 grams administered intravenously before surgery and metronidazole vaginal ovules 500mg twice a day for 5 days after performing laparoscopic hysterectomy
15865583|NCT03917134|Drug|cephalosporin + Placebos|administration of cephalosporin in doses of 2 grams administered intravenously before surgery and vaginal ovules of placebo twice a day for 5 days after performing laparoscopic hysterectomy
15865584|NCT03917121|Device|Jet injector|"The injection site will be dried with a sterile cotton swab and benzocaine 20% topical anesthetic gel/ Opahl® (Dharma Research, Inc., Miami, FL, USA) will be applied to the site using a cotton applicator for 2 mins prior to injection.
~Articaine hydrochloride 4% with epinephrine 1:100,000 anesthetic solution/ ARTINIBSA 4%® (Inibsa Dental S.L.U., Lliçà de Vall, Barcelona, Spain) will then be delivered using Madajet XL injector as per the manufacturer's instructions.
~A classical formocresol pulpotomy treatment procedure will be performed using formocresol/ Pyrocresol® (Pyrax Polymars, Roorkee, Uttarakhand, India) for fixation and polymer reinforced zinc oxide-eugenol/ Zinconol® (PREVEST DentPro, Digiana, Jammu, India) for restoration.
~Primary and secondary outcome variables will be measured and recorded via selected tools at pre-specified time points.
~All treated molars will be finally restored with stainless steel crowns or definitive restorations as indicated."
15865585|NCT03917121|Device|Needle attached dental syringe|"The injection site will be dried with a sterile cotton swab and benzocaine 20% topical anesthetic gel/ Opahl® (Dharma Research, Inc., Miami, FL, USA) will be applied to the site using a cotton applicator for 2 mins prior to injection.
~Articaine hydrochloride 4% with epinephrine 1:100,000 anesthetic solution/ ARTINIBSA 4%® (Inibsa Dental S.L.U., Lliçà de Vall, Barcelona, Spain) will then be delivered using standard needle-attached syringe in a classical local infiltration.
~A classical formocresol pulpotomy treatment procedure will be performed using formocresol/ Pyrocresol® (Pyrax Polymars, Roorkee, Uttarakhand, India) for fixation and polymer reinforced zinc oxide-eugenol/ Zinconol® (PREVEST DentPro, Digiana, Jammu, India) for restoration.
~Primary and secondary outcome variables will be measured and recorded via selected tools at pre-specified time points.
~All treated molars will be finally restored with stainless steel crowns or definitive restorations as indicated."
15865586|NCT03917108|Device|retraction cord|retraction cord ( Ultra dent sizes #0, #00, #000 ) is placed in the gingival sulcus using blunt instrument and using cotton roll isolation.
15865587|NCT03917108|Device|subgingival clamp|subgingival clamp (KSK clamps W8A, #44, #42, #43) or (Brinker clamps B5, B6) is placed to retract the gingiva with rubber dam isolation
15865588|NCT03917095|Device|The Colonic Transendoscopic enteral Tubing.|The medications were infused into the colon through the Colonic Transendoscopic enteral Tubing(TET).
15865589|NCT03917095|Drug|Glutamine|The medications were infused into the colon
15865590|NCT03917095|Drug|Mesalazine|The medications were infused into the colon
15865591|NCT03917082|Drug|Tamoxifen Citrate|current standard of care is 5 years endocrine therapy after early breast cancer. Intervention will test if 2 years is adequate for population with low recurrence risk based on genomic tissue based test
15865592|NCT03917069|Drug|Chemotherapeutic Combinations|nab-paclitaxel 260mg/m2 d1+Carboplatin AUC=5 d1+ endostatin 15mg d1-14，q28d
15865593|NCT03917069|Drug|chemotherapy|paclitaxel 175 mg/m2 d1+Carboplatin AUC=5 d1, q21d
15865594|NCT03917056|Procedure|Cap-assisted endoscopic sclerotherapy using long needle|Participants were treated with CAES using long needle.
15865595|NCT03917056|Procedure|Cap-assisted endoscopic sclerotherapy using short needle|Participants were treated with CAES using short needle.
15865596|NCT03917043|Drug|APG-2449|Capsule, multiple dose cohorts, oral administration every day (QD) of a 28-day cycle
15865597|NCT03917030|Procedure|Open flap debridement with osteoplasty|Treatment of furcation grade II defect with open flap debridement followed by osteoplasty treatment. Osteoplasty includes altering the bone buccal to the furcation opening to >90 degrees relative to the apico-coronal axis of the toot.
15865598|NCT03917030|Procedure|Open flap debridement without osteoplasty|Treatment of furcation grade II defect with open flap debridement only.
15865599|NCT03917017|Device|Radiomics and Watson artificial intelligence|"The artificial intelligence platform developed by IBM Watson can provide treatment decisions and corresponding theoretical basis to guide surgical decisions based on the key clinical data of liver cancer patients.
~The imaging histology can be used to conduct intraoperative navigation surgical resection and treatment monitoring, and established a prognosis model to predict the prognosis of patients by grading the results of postoperative follow-up and microvascular invasion of pathological liver cancer, so as to better achieve accurate diagnosis and treatment of the disease."
15865600|NCT03917004|Drug|Nitroglycerin|"The starting rate of nitroglycerin was 0.25 μg / kg / min and the mean arterial pressure (MAP) decreased to 80% of the baseline but not less than 70%.The drug infusion rate was adjusted so that the MAP was maintained in the range to the suture, and the administration was stopped and the blood pressure was gradually returned to the pre-depressurization level."
15865601|NCT03916991|Other|Exercise|Hip focused Neuromuscular Activation Exercise
15865602|NCT03916978|Biological|Autologous PRP intra ovarian infusion|Autologous PRP intra ovarian infusion
15865603|NCT03916978|Biological|Autologous PFP intra ovarian infusion|Autologous PFP intra ovarian infusion
15865604|NCT03916952|Diagnostic Test|Six Minute Walk Test|The patients walked as far as possible for 6 minutes--over two separate trials. In one trial, an examiner walked with the participant. In the second trial, the participant walked independently. A paired T test was performed to see if there was a significant difference in the distance walked or gait speed between the trials.
15865605|NCT03916939|Other|osteopathy|osteopathy treatment
15865606|NCT03916939|Other|simulated osteopathy|simulated osteopathic sessions
15865607|NCT03916926|Device|"A simple medical strategy consisting of silver diamine fluoride (SDF)"|Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL)
15865608|NCT03916926|Device|"B typical dental strategy consisting of atraumatic restorative treatment (ART) with glass ionomer cement + Fluoride varnish (FV)"|GC Fuji (for ART) and FluoriMax Advantage Arrest, Elevate Oral Care LLC., West Palm Beach, FL (for FV)
15865609|NCT03916913|Radiation|Local radiation therapy|Local radiotherapy on all sites of disease including primary and metastatic lesions
15865610|NCT03916900|Procedure|Pulpotomy|Pulpotomy is a procedure in which the coronal pulp is amputated, and the remaining radicular pulp tissue is treated with a medicament to preserve the pulp's health .This technique involves administration of local analgesia, Isolation of the tooth with rubber dam, Complete caries removal and then access to the pulp chamber using drills
15865611|NCT03916900|Procedure|Root canal treatment|Root canal treatment is an often straightforward procedure to relieve dental pain and save teeth. Patients typically need a root canal when there is inflammation or infection in the roots of a tooth. During root canal treatment, an endodontist who specializes in such treatment carefully removes the pulp inside the tooth, cleans, disinfects and shapes the root canals, and places a filling to seal the space.
15865612|NCT03916887|Behavioral|Golf instruction|Non-golfers instructed to golf over 10 weeks
15865613|NCT03916861|Device|Bioelectrical Impedance Analysis|We use Inbody S20 analysis to measure fluid status before each hemodialysis session to guide fluid removal.
15865614|NCT03916861|Procedure|Physician-guided|This intervention used physical examination as guided to adjust fluid therapy together with the chart record of intake and output per day
15865615|NCT03916848|Procedure|Combined Micro-Macro SEEG Electrodes|The novel combined micro-macro electrodes will then be used during the surgical implantation procedure. The use of these novel electrodes will not change the surgical procedure, which is conducted using robotic assistance to ensure optimal accuracy. The macro electrode recordings will be used for routine clinical analysis and the duration of recording and subsequent analysis of the recordings will not be affected by the micro electrode data captured for research purposes. The clinical SEEG also involves electrical stimulation of the brain which will not be affected by the study.
15865616|NCT03916835|Device|Pain evaluation ( FLACC scale) before and during the cleaning care with and without music therapy.|"Each child will benefit two cleaning cares during hospitalization. One with music therapy and the other without music therapy.
~Every time, the preparation will be the same with an equipment installation in order to keep comparability and blind.
~Child will be videotaped without sound during the care. The order of music therapy intervention will be randomized."
15865617|NCT03916822|Diagnostic Test|Alloantigen-specific B-cells|Alloantigen-specific B-cells which express CD154 and their subsets which also co-express cytokines, memory and naive markers, and additional derivatives of these markers will be measured with flow cytometry
15865618|NCT03916809|Other|EMST|Expiratory muscle strength training (EMST) is an exercise program designed to strengthen the muscles of expiration by increasing expiratory load during breathing exercises using either resistive or pressure threshold devices. The EMST150 is a commercially-available device considered non-significant risk (NSR). The EMST150 device will be used for this study.
15865619|NCT03916796|Other|Exercise|-The exercise part will consist of an evaluation and treatment as prescribed by a physical therapist including aerobic & dynamic stretching warm-up, strength training, balance training, and flexibility training. Will also include a home exercise program (HEP). Physical therapists will have specialized training in cancer rehabilitation obtained through the ReVital certification process.
15865620|NCT03916796|Other|Enhanced Recovery after surgery|-The protocols include instructions for patient care from the time of pre-surgical admission to discharge, including directives regarding diet, labs, IV fluids, pain management, prophylactic medications, management of indwelling catheters and drains, and activity.
15865621|NCT03916796|Other|Psychological screening with counselling services as needed|-The psychological screening will be completed by the Radiation Oncology nurse at the consult visit
15865622|NCT03916796|Other|Dietary Counseling Services|-Patients will have a baseline nutrition counseling visit with a Registered Dietician. This may include a nutrition assessment and nutrition counseling to set priorities, establish goals, and create an individualized plan
15865623|NCT03916783|Behavioral|Combination intervention|"The FDA will be a matched savings account held in the child's name with the parent or caregiver as the co-signer, in a financial institution registered by the Central Bank (Bank of Uganda). The account opened will be matched with money from the program up to a match cap of 72,000 Uganda shillings (an equivalent of $20) a month per family for the 9-month intervention period.
~The FDAs will be complemented with four sessions of Financial Literacy and Management (FL&M) and two sessions of cancer education conducted over a 4-week period. The two cancer-specific education sessions will use UCI materials to address: 1) definitions of cancer, potential causes, signs and symptoms, and importance of cancer testing; 2) debunking cultural explanations for the causes of cancer and misconceptions (beliefs, values, norms and prevailing attitudes)regarding cancer that largely impede service use."
15865624|NCT03916770|Device|Sham vibrator|The Sham control group will have WBV the same time,in the same position with the same frequency but 99.5% weakened amplitude.
15865625|NCT03916770|Device|Real vibrator|The intervention group will have WBV(frequency:30Hz,amplitude:2,2mm,at upright position
15865626|NCT03916757|Biological|V-Boost|Open label setting
15865627|NCT03916744|Drug|Giredestrant|Giredestrant will be administered orally once daily (QD) starting on Day 1 up to and including the day of surgery (if allowed per local process) on Day 15 (+/-2 days).
15865628|NCT03916744|Procedure|Surgery|Breast cancer surgery will take place on Day 15 (+/-2 days).
15865629|NCT03916731|Device|STARgraft AV|Implant of STARgraft AV shunt in the upper arm and subsequent use for hemodialysis access. After healing from the surgical procedure the graft will be routinely cannulated for hemodialysis sessions. Periodic evaluations of blood flow by ultrasound imaging will be made over the study period. Established standards of care will be followed as needed to maintain dialysis function.
15865630|NCT03916731|Device|ePTFE AV graft (control)|Implant of standard ePTFE AV shunt as a control in the upper arm and subsequent use for hemodialysis access. After healing from the surgical procedure the graft will be routinely cannulated for hemodialysis sessions. Periodic evaluations of blood flow by ultrasound imaging will be made over the study period. Established standards of care will be followed as needed to maintain dialysis function.
15865665|NCT03916497|Diagnostic Test|Quantiferon CMV|Evaluate and compare interferon gamma (IFNy) production by T CD8 cells exposed to CMV antigens in CMV seropositive kidney transplant recipients, hemodialysis and control patients
15865702|NCT03916237|Other|Home remediation|Low level home remediation according to previously established protocol (Kercsmar CM, Dearborn DG, Schluchter M, et al. Reduction in asthma morbidity in children as a result of home remediation aimed at moisture sources. Environ Health Perspect. 2006;114(10):1574-80)
15866024|NCT03913624|Other|Neuromuscular electrical stimulation|
15865631|NCT03916718|Behavioral|Care EcoSystem|This is a care management program and health care outcomes feasibility study utilizing the dementia Care Ecosystem (CE) program developed at UCSF and tailored to high need Ochsner PWD (patient with dementia) and their CGs (caregivers). Dyads (CGs and PWD) will receive a tailored clinical assessment addressing dementia severity, PWD and CG needs, education/strategies to management common dementia issues, medical issues and medication reconciliation, caregiver wellness strategies, linkages to community-based resources, advance care planning, education about the risk of ED and hospitalization, and care coordination with other specialties. Dyads will be followed on a monthly basis to monitor needs, provide support, and problem solve issues.
15865632|NCT03916705|Other|High Velocity Low amplitude spinal manipulation (HVLA-SM)|HVLA-SM is a commonly used spinal manipulation treatment for patients with chronic low back pain.
15865633|NCT03916692|Dietary Supplement|Carbohydrate drink|Meal replacement drink containing 200 kcal
15865634|NCT03916692|Dietary Supplement|Energy smart Carbohydrate blend|Carbohydrate blend drink designed for low glycemic responses containing 200 kcal
15865635|NCT03916692|Dietary Supplement|Liquid Dextrose|Liquid Dextrose drink of 200 kcal
15865636|NCT03916679|Biological|anti-MESO CAR-T cells|Retroviral vector-transduced autologous T cells to express anti-MESO CARs
15865637|NCT03916666|Procedure|Epiduroscopy|Endoscopic intervention
15865638|NCT03916653|Procedure|osseous resection using piezoelectric device in surgical crown lengthening|In this group piezoelectric device will be used for osseous resection in crown lengthening procedure with copious irrigation of sterile saline.
15865639|NCT03916653|Procedure|Osseous resection using conventional rotary instruments in surgical crown lengthening|For osseous resection in crown lengthening procedure, conventional rotary instruments will be used with copious irrigation of sterile saline.
15865640|NCT03916640|Drug|ADO09 formulation|Subcutaneous injection of ADO09 formulation
15865641|NCT03916640|Drug|Placebo|Subcutaneous injection of 0.9% NaCl
15865642|NCT03916640|Drug|Symlin®|Subcutaneous injection of pramlintide
15865643|NCT03916640|Drug|Humulin®|Subcutaneous injection of human insulin
15865644|NCT03916640|Drug|Humalog®|Subcutaneous injection of insulin lispro
15865645|NCT03916627|Drug|cemiplimab|Administered intravenous (IV)
15865646|NCT03916627|Drug|Platinum Doublet|Administered intravenous (IV)
15865647|NCT03916614|Behavioral|Screening Tool for Relief of Trauma (START)|The Screening and Tool for Awareness and Relief of Trauma (START) was developed for patients that come from communities with sustained and persistent trauma. It consists of six screening questions adapted from the validated Primary Care PTSD Screen,[30] with input from focus groups, surveys and in-depth interviews with victims of violence. The full START intervention requires 30-45 minutes of structured conversation at the end of which the participant leaves with a better understanding of trauma symptoms as well as on-the-spot instruction on a set of techniques designed to alleviate the symptoms of PTSD. Based on the results of their screening, the participant will be offered up to four techniques to alleviate their symptoms
15865648|NCT03916614|Behavioral|standard of care|Screening for PTSD and referral for outpatient services if warranted as well as usual care from Violence Prevention and Outreach Program (VPOP) staff.
15865649|NCT03916601|Drug|SAR341402|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous"
15865650|NCT03916601|Drug|Insulin Aspart|"Pharmaceutical form: suspension for injection
~Route of administration: subcutaneous"
15865651|NCT03916601|Drug|Insulin Aspart|"Pharmaceutical form: suspension for injection
~Route of administration: subcutaneous"
15865652|NCT03916601|Drug|SAR341402|"Pharmaceutical form: suspension for injection
~Route of administration: subcutaneous"
15865653|NCT03916588|Behavioral|Individualized Care Plan|Medical, neuropsychological, and social assessment of patient's cognitive, behavioral, medical, and environmental needs with a focus on improving quality of life, reducing health care utilization, and improving staff/family caregiving burden along with a specific plan to address and monitor identified patient and staff/facility needs
15865654|NCT03916562|Behavioral|Manipulation of spatiotemporal coordination during walking|A description of the intervention is included in the description of the study arms.
15865655|NCT03916549|Device|Acupuncture|The acupuncture procedure is performed by one well trained person, 1 time per week in total of 10 weeks on the same day time. Sterile, disposable, stainless steel acupuncture needles (40x0.25 mm diameter) were inserted to corporal acupoints, with initial gentle stimulation by quick rotation of 1080°, after then leaving needle in located place for twenty minutes. Needling deep - 0.5-1 cm. If the intent was to invigorate - the needle was inserted to the flow of energy; if harmonization needed - the needle was placed perpendicular to the point flow of energy; if sedation was needed, needles were placed against to the flow of energy on channel. The selection of acupoints was based according by traditional Chinese medicine, literature findings.
15865656|NCT03916536|Procedure|Holmium Laser|Holmium laser enucleation of large sized prostate
15865657|NCT03916536|Procedure|Thulium Laser|Thulium laser enucleation of large sized prostate
15865658|NCT03916536|Procedure|Bipolar diathermy|Bipolar enucleation of large sized prostate
15865659|NCT03916523|Procedure|Sustained lung inflation|"Preterm infants will receive a total of 15 sustained lung inflations during the first 4 days of life as follows:
~On day 1 of life (a total of 6 sustained lung inflations, 20 cmH2O for 21 seconds each) once at enrollment and then once every 4 hours
~On day 2 of life (a total of 3 sustained lung inflations, 15 cmH2O for 21 seconds each) once every 8 hours.
~On day 3 of life (a total of 3 sustained lung inflations 10cmH2O for 21 seconds each) once every 8 hours.
~On day 4 of life (a total of 3 sustained lung inflations 10cmH2O for 21 seconds each) once every 8 hours."
15865660|NCT03916523|Procedure|Continuous positive airway pressure (CPAP)|Preterm infants will receive CPAP for respiratory support.
15865661|NCT03916523|Procedure|Mechanical ventilation|Preterm infants in this group will receive mechanical ventilation for respiratory support
15865662|NCT03916510|Biological|Enadenotucirev|Enadenotucirev is a live replicating oncolytic adenovirus; it is considered a BioSafety Level 1 (BSL-1) infectious substance.
15865663|NCT03916510|Drug|Capecitabine|Capecitabine is a chemotherapy drug licensed for use in rectal cancer, it is a non-cytotoxic pre-cursor of the cytotoxic 5-fluorouracil. Due to Capecitabine not being taken on Enadenotucirev dosing days it is considered an investigational medicinal product within this trial.
15865664|NCT03916510|Radiation|Radiotherapy|50 Gy/25#
15865666|NCT03916484|Behavioral|AllyQuest HIV Medication Adherence app-delivered intervention|"AQ provides daily ART reminders and calendar; weekly tailored message; monthly appointment and refill reminders; social support via daily chat wall; daily challenge featuring skills-building and articles; education center; narrative collections; in app account rewards daily use by adding or subtracting small financial reward dependent on daily app use; personalized profile and avatar. Participants have 24-hour access to all features of the AQ app."
15865667|NCT03916484|Behavioral|AllyQuest HIV Medication Adherence app-delivered intervention + NSC|In AQ+, participants receive all of AQ and have the added ability to text in the app with an adherence counselor, using Next Step Counseling (NSC). NSC is an interactive, client-centered motivational intervention to improve ART adherence. Key components of NSC include: review experiences with adherence, exploration of adherence facilitators and barriers, identification of adherence needs, identification of strategies to meet needs, and development of an adherence action plan. AQ+ includes unprompted check-in messages from the NSC counselor and scheduled in-app NSC sessions approximately every other week.
15865668|NCT03916471|Device|Solyx™ SIS System|Single-incision sling system
15865669|NCT03916471|Device|Obtryx™ II System (Halo)|Transobturator Mid-urethral Sling System
15865670|NCT03916445|Other|Connor Davidson Resilience Scale (CD-RISC 10)|questionnaires about resilience (Connor Davidson Resilience Scale(CD-RISC 10)) and quality of life (EQ-5D-5L)
15865671|NCT03916432|Device|HELIOS biodegradable polymer sirolimus-eluting stents|HELIOS biodegradable polymer sirolimus-eluting stents
15865672|NCT03916419|Device|ViewRay MR-Linear Accelerator|-Radiation will be delivered by this machine
15865673|NCT03916419|Radiation|Radiation therapy|-60Gy in 15 fractions
15865674|NCT03916419|Drug|Paclitaxel|-50 mg/m^2 intravenous
15865675|NCT03916419|Drug|Carboplatin AUC|-2 mg/mL/min intravenous over 30 minutes
15865676|NCT03916419|Biological|Durvalumab|-10 mg/kg
15865677|NCT03916406|Drug|PF 06835919|300 mg
15865678|NCT03916406|Drug|Midazolam|7.5 mg
15865679|NCT03916393|Drug|PF-06651600 20 mg|PF-06651600 in four (4) different oral formulations will be administered in different periods.
15865680|NCT03916393|Other|Bitrex solution|Bitrex solution at 0.5 ppm will be included in the treatment sequence together with the four PF-06651600 formulations.
15865681|NCT03916380|Dietary Supplement|Grapefruit Juice|Single 8 ounce administration of oral grapefruit juice
15865682|NCT03916367|Radiation|CT-guided Radioactive I-125 Seeds Implantation|The radioactive Iodine-125 seed can release low dose of irradiation persistently which kills tumors cell and causes less damage to normal tissue at the same time. The treatment was performed under CT monitoring.
15865683|NCT03916341|Other|EC with nicotine|Use an EC with nicotine for up to 30 minutes
15865684|NCT03916341|Other|EC without nicotine|Use an EC without nicotine for up to 30 minutes
15865685|NCT03916341|Other|control|sham control
15865686|NCT03916341|Other|TC with nicotine (own brand)|smoke a TC
15865687|NCT03916341|Other|research TC with very low level nicotine|smoke a research TC with very low level nicotine
15865688|NCT03916328|Drug|B/F/TAF|A third of the women will be randomized to Bictergravir /Emtricitabine / Tenofovir alafenamide (B/F/TAF; Biktarvy®).
15865689|NCT03916328|Drug|TDF/3TC/EFV or DTG or NVP|A third of the women will remain on Tenofovir Disoproxil Fumurate.(TDF) containing ART.
15865690|NCT03916328|Other|DMPA|Two thirds of the women will be on DMPA for contraception.
15865691|NCT03916315|Behavioral|Transdiagnostic Treatment|"The Unified Transdiagnostic Protocol (PUT) is a cognitive-behavioral treatment focused on emotions. The PUT was developed to be applicable to anxiety disorders, mood disorders, as well as other disorders in which anxiety and emotional dysregulation play an important role, such as many somatoform and dissociative disorders.
~The PUT proposal includes 8 modules, of which 5 are nuclear, it is recommended to give these modules between 11 to 17 sessions with a duration of one hour each."
15865692|NCT03916289|Other|No intervention would be taken|No intervention would be taken. Patients enrolled would be managed by this tiered diagnosis and treatment system and receive standard treatment according to clinical guidelines of osteoporosis.
15865693|NCT03916276|Behavioral|Cognitive Therapy (CT)|"The cognitive-restructuring technique will be used to help participants recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts; recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via weighing the evidence; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs."
15865694|NCT03916276|Behavioral|Mindfulness Meditation (MM)|Participants will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. A standard script will be implemented by the clinician, and participants will be seated in a comfortable yet alert position.
15865695|NCT03916276|Behavioral|Activation Skills (AS)|Participants will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.
15865699|NCT03916250|Drug|PF-06700841 cream|PF-06700841 will be applied topically
15865700|NCT03916250|Drug|White petrolatum|White petrolatum will be applied topically
15865701|NCT03916237|Other|Home assessment|Home assessment for environmental hazards according to protocol established by Environmental Health Watch (Healthy Home Audit https://www.ehw.org/healthy-home-audit/)
15881663|NCT03792217|Other|5.25% NaOCl|Endodontic irrigant
15865703|NCT03916237|Other|Referral to Medical Legal Partnership|Medical Legal Partnership referral as described by the National Center for Medical Legal partnerships and others (Beck AF, Identifying and treating a substandard housing cluster using a medical-legal partnership. Pediatrics. 2012;130(5):831-838)
15865704|NCT03916237|Other|Regular School Based Health Asthma Care|Regular care in the School Health Program
15865705|NCT03916211|Biological|MSCs treatment|intramuscular injection of adipose stem cells treat diabetic foot
15865706|NCT03916198|Drug|Polydeoxyribonucleotides|Just after arthroscopic rotator cuff repair, 3cc polydeoxyribonucleotide will be injected, and 2 weeks after the surgery the same amount of the material will be injected.
15865707|NCT03916198|Drug|Normal saline|Just after arthroscopic rotator cuff repair, 3cc normal saline will be injected, and 2 weeks after the surgery the same amount of the material will be injected.
15865708|NCT03916185|Biological|RSV ΔNS2/Δ1313/I1314L Vaccine|10^6 plaque-forming units (PFU); administered as nose drops
15865709|NCT03916185|Biological|RSV 6120/ΔNS2/1030s Vaccine|10^5 plaque-forming units (PFU); administered as nose drops
15865710|NCT03916185|Biological|RSV 276 Vaccine|10^5 plaque-forming units (PFU); administered as nose drops
15865711|NCT03916185|Biological|Placebo|Administered as nose drops
15865712|NCT03916172|Behavioral|The Open Door Approach to Parenting Teenagers (APT)|APT works on a one-to-one or couple basis. It offers 6 weekly 50-minute appointments with an optional 7th review session. The practitioners delivering the intervention have qualifications in psychology, or significant experience of working with adolescent populations, and have undertaken training and supervision in the model. Its aim is to help the parent manage the parenting of their teenager more effectively and establish a more balanced relationship by eliciting their views, feelings, and understanding of their teenager and their relationship, discussing their parental identity and role, carefully examining communication, responses, and information giving, and supporting appropriate boundary making. This is achieved through a collaborative development of strategies, psychoeducation and behavioural experiments.
15865713|NCT03916159|Procedure|Extrauterine placental transfusion (Intervention group)|At delivery by caesarean section, the infant is born with the placenta still attached via the umbilical cord and placental transfusion is performed at least 1 minute but not more than 10 minutes by holding the placenta ~40-50cm above the babies' heart level while respiratory support by mask continuous-positive-airway-pressure (CPAP) is initiated simultaneously.
15865714|NCT03916159|Procedure|Delayed cord clamping (Control group)|At delivery by caesarean section, delayed cord clamping will be performed by having the delivering obstetrician delay clamping of the umbilical cord for at least 30 seconds with initiation of respiratory support by mask CPAP after cord clamping.
15865715|NCT03916146|Behavioral|Parent Training Intervention|Adapted version of the Family Check-Up/Everyday Parenting intervention
15865716|NCT03916133|Diagnostic Test|Intervention group|6s PBV mapping will be conducted
15865717|NCT03916120|Genetic|Genetic analysis|Collect 2ml intravenous blood from patients after anaesthesia.
15865718|NCT03916107|Procedure|Levator muscle and tarsus resection|Shortening the levator muscle with resection of tarsus to correct severe ptosis
15865719|NCT03916107|Procedure|Frontalis flap|Using frontal muscle flap to correct severe ptosis
15865720|NCT03916094|Drug|HLX22|Humanized Anti-Human Epidermal Growth Factor Receptor-2 Monoclonal Antibody
15865721|NCT03916081|Drug|ARQ-151 cream 0.05%|0.05% active concentration
15865722|NCT03916081|Drug|ARQ-151 cream 0.15%|0.15% active concentration
15865723|NCT03916081|Drug|ARQ-151 cream Vehicle|Cream placebo
15865724|NCT03916068|Procedure|Hyperbaric Oxygen Therapy|Hyperbaric oxygen therapy at 2.4 atmospheres for 90 minutes for 30 sessions.
15865725|NCT03916068|Drug|Trental Pill|Trental 400 mg three times daily, in combination with Vitamin E 400 IU twice daily
15865726|NCT03916068|Dietary Supplement|Vitamin E|Vitamin E 400 IU twice daily, in combination with Trental 400 mg three times daily
15865727|NCT03916055|Behavioral|Exposure and response prevention (ERP)|"The intervention consists of 10 modules/chapters for children/adolescents, delivered over 10. Each of the 10 modules includes age-appropriate texts, animations and exercises. The intervention is primarily based on ERP techniques. During the treatment, participants are instructed to practice suppressing their tics, this is known as 'response prevention'. Then, with the help of their caregiver/parent, the participant is instructed to provoke premonitory urges (a sensation usually felt before a tic is expressed), while still suppressing tics, which is known as 'exposure'.
~The parent is provided with her/his own separate login to the internet platform, which consists of 10 separate modules/chapters. The parent intervention consists mainly of information regarding parent coping strategies, social support and functional analysis relating to tics. Both the child/adolescent and the parent have individual access to the same therapist."
15865728|NCT03916055|Behavioral|Education on tics|"The active comparator is designed to match the experimental intervention in all aspects except for the module content (same platform, same treatment length, same therapist support etc.). The intervention consists mainly of psychoeducational information about TD/PTD and common comorbid conditions, and reviews the definition of tics, natural history, common presentations, prevalence, aetiology, risks and protective factors, strategies for describing tics to other people, among others. Problem-solving and development of expertise in tic disorders is emphasised. The intervention does not include any information on ERP or functional analysis and interventions.
~As in the experimental intervention, the parent is provided with her/his own separate login to the internet platform. The parent intervention consists mainly of information regarding parent coping strategies and social support. Both the child and the parent have individual access to the same therapist."
15865729|NCT03916042|Drug|Reproxalap Ophthalmic Solution (0.25% Novel Formulation) QID to BID|Reproxalap Opthalmic Solution (0.25% Novel Formulation) administered QID for four weeks, followed by BID administration for eight weeks
15865730|NCT03916042|Drug|Vehicle Ophthalmic Solution (0.25% Novel Formulation) QID to BID|Vehicle Ophthalmic Solution administered QID for four weeks, followed by BID administration for eight weeks
15865731|NCT03916029|Behavioral|facilitator|Training and employment of community members to assist the diagnosis and management of otitis media
15865767|NCT03915704|Device|Buzzy|Buzzy was placed 3-5 cm above the injection site 60 sec before the injection and used until the procedure was completed.The Buzzy application to all children in this group was done by the second researcher. After the injection, the ice pack was wiped with 70% alcohol and frozen again by freezing.
15865732|NCT03916016|Behavioral|Enhanced Integrated Behavioral Health Care|The intervention involved moving from HFHC's previous collaborative model, where medical and behavioral providers worked with each other episodically, to a more fully integrated collaborative care model with care coordination, shared treatment plans, shared service provision, and shared record keeping. To achieve this enhanced level of integration, HFHC changed its current primary care workflow to include a behavioral health specialist who conducted assessments, provided initial counseling (individual or group), and coordinated referrals to care management and/or community-based health services.
15865733|NCT03916016|Behavioral|Usual Care|A collaborative model where medical and behavioral providers worked with each other episodically
15865734|NCT03916003|Drug|primaquine|Primaquine regimen over 7 days (1.0 mg/kg/day for 7 days)
15865735|NCT03915990|Diagnostic Test|umbilical and middle cerebral artery Doppler|Umbilical and middle cerebral arteries Doppler indices (resistance index and pulsatility index) and Cerebroplacental Doppler ratio will be measured for every patient.
15865736|NCT03915977|Behavioral|Post ICU recovery program|Standardized follow up program
15865737|NCT03915964|Drug|Baricitinib|Administered orally.
15865738|NCT03915964|Drug|TNF Inhibitor|Administered SC
15865739|NCT03915951|Drug|encorafenib|self-administered orally
15865740|NCT03915951|Drug|binimetinib|self-administered orally
15865741|NCT03915938|Drug|Ketamine|S-ketamine will be administered in precalculated infusion rates to obtain a plasmatic level of 60 ng/ml
15865742|NCT03915938|Drug|Placebo|Administered in an identical way than ketamine.
15865743|NCT03915912|Behavioral|Mindfulness meditation|The study intervention consists of seven mindfulness sessions (six 1-hour telephone sessions and one 1-hour in-person session). The six weekly telephone-based mindfulness sessions will occur in a one-on-one format and will be followed by one in-person, one-on-one session, which will occur at the post-chemoradiation standard of care clinic visit.
15865744|NCT03915899|Behavioral|WIN (Welcome Incoming Neighbor)|WINs will conduct active community surveillance to rapidly identify and welcome in-migrants, provide them with information about the availability of CHP, utilize a motivational interviewing approach to encourage CHP adoption, refer in-migrants to free services, and follow-up in-migrants to assess and further encourage engagement in CHP.
15865745|NCT03915886|Drug|JNJ-0440|JNJ-0440 tablets will be administered orally.
15865746|NCT03915886|Drug|Placebo|Matching placebo tablets will be administered orally.
15865747|NCT03915873|Diagnostic Test|The von Willebrand Antigen level|blood sample
15865748|NCT03915860|Drug|Trifarotene|Topical Cream
15865749|NCT03915847|Procedure|Single layer closure|Uterine incision will be approximated with continuous unlocked suture, including a narrow band of the endometrial layer, without trimming incision edges.
15865750|NCT03915847|Procedure|Double layer closure|The first layer suture penetrated the whole thickness of the uterine wall, including a narrow band of the endometrial layer. Second layer sture is acontinous sture performed in a lateral-to lateral position , imbricating first layer.
15865751|NCT03915847|Procedure|Doble layer closure with trimming|Uterine incision will be trimmed and old scar tissue will be removed. The first layer suture penetrated the whole thickness of the uterine wall, including a narrow band of the endometrial layer. Second layer sture is acontinous sture performed in a lateral-to lateral position , imbricating first layer.
15865752|NCT03915834|Device|Endovascular treatment|Mechanical thrombectomy and/or Aspiration
15865753|NCT03915821|Device|ECT|"Electroconvulsive therapy was administered by using bidirectional constant current, brief-pulse devices. During the procedure, the patients were sedated using propofol or thiopenthal. Succinylcholine (1 mg/kg) was used as muscle relaxant, and glycopyrrolate (0.2 mg) or atropine was used as an anticholinergic agent when necessary. The mean charges were 351 (SD, 143) mC for the unilateral electrode placement group, 417 (SD, 192) mC for the bitemporal electrode placement group and 260 (SD, 76) mC for the bifrontal electrode placement group, (Brus, Ole MSc, 2017).
~The average course of treatment for depression is 6 to 12 treatments, but some patients may require as many as 20 treatments,"
15865754|NCT03915808|Dietary Supplement|Conjugated linoleic acid group|supplementation of 3.2 g/day conjugated linoleic acid in 8 capsules, and receive education sessions every four weeks (Dietary and lifestyle counselling, featured with low fat and low added sugar, moderate physical activity)
15865755|NCT03915808|Dietary Supplement|Sunflower oil group|supplementation of equivalent sunflower oil in 8 capsules, and receive education sessions every four weeks (Dietary and lifestyle counselling, featured with low fat and low added sugar, moderate physical activity)
15865756|NCT03915782|Device|Remote ischemic conditioning|Remote ischemic conditioning (RIC): Four cycles of [5 minutes of brachial cuff inflation at 200 millimeters (mm) of mercury (Hg) followed by 5 minutes of cuff deflation] started as soon as possible after Magnetic Resonance Imaging (MRI).
15865757|NCT03915782|Device|Patients with a sham procedure of remote ischemic conditioning|Sham procedure: Four cycles of [5 minutes of brachial cuff inflation at 30 millimeters (mm) of mercury (Hg) followed by 5 minutes of cuff deflation] started as soon as possible after Magnetic Resonance Imaging (MRI).
15865758|NCT03915769|Drug|Ozanimod|Ozanimod is an orally bioavailable, small molecule compound that activates the sphingosine 1-phosphate 1 receptor (S1P1) and the S1P 5 receptor (S1P5), although it is more selective towards S1P1 over S1P5
15865759|NCT03915769|Other|Placebo|The placebo is a capsule that contains no study medication but looks exactly like the study medication capsule.
15865760|NCT03915756|Procedure|Drainage of surgical wound|Introduction of a drain before full fascial closure
15865761|NCT03915743|Other|palliative care|complex and multi-faceted individualized palliative care
15865762|NCT03915730|Other|Initial periodontal therapy|Scaling and root planing and polishing with specific curettes were performed to patients with CP and oral hygiene education was provided to each patient.
15865763|NCT03915717|Device|EchoMark|EchoMark is implanted during surgery to mark the at-risk blood vessels to enable EchoSure ultrasound-based monitoring
15865764|NCT03915717|Device|EchoSure|EchoSure ultrasound scans are performed to monitor the free flap
15865765|NCT03915704|Device|Shotblocker|Injection was administered with ShotBlocker.The Shotblocker application to all children in this group was done by the second researcher. After the injection, the shotblocker was wiped with 70% alcohol.
15865766|NCT03915704|Procedure|Control|No intervention was made in the children.
15865768|NCT03915691|Procedure|Catheter ablation of atrial tachycardia: Ripple Mapping guided.|Ripple Mapping (CARTO3v6 mapping system, Biosense Webster Inc) is used to map the atrial tachycardia mechanism. The Ripple Map is interpreted and catheter ablation directed to the site of the heart identified as putative to the arrhythmia mechanism. All ablation lesions are confirmed to have conduction block across them using Ripple Mapping. This can include lesions created at previous ablation procedures.
15865769|NCT03915691|Procedure|Catheter ablation of atrial tachycardia: Conventional mapping guided.|Conventional activation mapping (CARTO3v6 mapping system, Biosense Webster Inc) is used to map the atrial tachycardia mechanism. The resultant (activation) map is interpreted and ablation directed to the site of the heart identified as putative to the arrhythmia mechanism. All ablation lesions are confirmed to have conduction block across them using conventional mapping. This can include lesions created at previous ablation procedures.
15865770|NCT03915678|Drug|Association atezolizumab + BDB001 + RT|"A treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg).
~BDB001 will be administered by a 30-minute intravenous infusion before atezolizumab, on Days 1, 8, and 15 of cycles 1, 2, and 3. Then from cycle 4 BDB001 will be administered on Day 1 every 3 weeks.
~Radiotherapy will start at least one week after the first administration of atezolizumab and at the latest before the 2nd administration. All participants will be treated by high dose irradiation in stereotactic conditions on non-injected metastasis: 3 to 5 fractions for a total dose between 27 Gy and 60 Gy."
15865771|NCT03915678|Drug|Association atezolizumab + BDB001+ RT|"A treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg).
~BDB001 will be administered by a 30-minute intravenous infusion before atezolizumab, on Days 1, 8, and 15 of cycles 1, 2, and 3. Then from cycle 4 BDB001 will be administered on Day 1 every 3 weeks.
~Radiotherapy will start at least one week after the first administration of atezolizumab and at the latest before the 2nd administration. All participants will be treated by high dose irradiation in stereotactic conditions on non-injected metastasis: 3 to 5 fractions for a total dose between 27 Gy and 60 Gy."
15865772|NCT03915678|Drug|Association atezolizumab + BDB001+ RT|"A treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg).
~BDB001 will be administered by a 30-minute intravenous infusion before atezolizumab, on Days 1, 8, and 15 of cycles 1, 2, and 3. Then from cycle 4 BDB001 will be administered on Day 1 every 3 weeks.
~Radiotherapy will start at least one week after the first administration of atezolizumab and at the latest before the 2nd administration. All participants will be treated by high dose irradiation in stereotactic conditions on non-injected metastasis: 3 to 5 fractions for a total dose between 27 Gy and 60 Gy."
15865773|NCT03915678|Drug|Association atezolizumab + BDB001 + RT|"A treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg).
~BDB001 will be administered by a 30-minute intravenous infusion before atezolizumab, on Days 1, 8, and 15 of cycles 1, 2, and 3. Then from cycle 4 BDB001 will be administered on Day 1 every 3 weeks.
~Radiotherapy will start at least one week after the first administration of atezolizumab and at the latest before the 2nd administration. All participants will be treated by high dose irradiation in stereotactic conditions on non-injected metastasis: 3 to 5 fractions for a total dose between 27 Gy and 60 Gy."
15865774|NCT03915678|Drug|Association atezolizumab + BDB001 + RT|"A treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg).
~BDB001 will be administered by a 30-minute intravenous infusion before atezolizumab, on Days 1, 8, and 15 of cycles 1, 2, and 3. Then from cycle 4 BDB001 will be administered on Day 1 every 3 weeks.
~Radiotherapy will start at least one week after the first administration of atezolizumab and at the latest before the 2nd administration. All participants will be treated by high dose irradiation in stereotactic conditions on non-injected metastasis: 3 to 5 fractions for a total dose between 27 Gy and 60 Gy."
15865775|NCT03915678|Drug|Association atezolizumab + BDB001 + RT|"A treatment cycle consits of 3 weeks. Atezolizumab will be administered as a 1-hour infusion on day 1 every 3 weeks (1200 mg).
~BDB001 will be administered by a 30-minute intravenous infusion before atezolizumab, on Days 1, 8, and 15 of cycles 1, 2, and 3. Then from cycle 4 BDB001 will be administered on Day 1 every 3 weeks.
~Radiotherapy will start at least one week after the first administration of atezolizumab and at the latest before the 2nd administration. All participants will be treated by high dose irradiation in stereotactic conditions on non-injected metastasis: 3 to 5 fractions for a total dose between 27 Gy and 60 Gy."
15865776|NCT03915665|Drug|Chlorhexidine|Chlorhexidine gel 1% one single application after mechanical biofilm removal through manual instruments
15865777|NCT03915665|Device|Air-powder|Erythritol powder using air-powder device
15865778|NCT03915652|Behavioral|Rheum iCMP|Selected iCMP nurses will receive a 4-hour training using unique educational materials already developed by our team that specifically address lupus-related racial, ethnic and socioeconomic disparities, as well as clinical information about lupus. These iCMP nurses will then reach out to high-risk lupus patients to ensure that patients attend scheduled rheumatology appointments, fill prescriptions for lupus-specific medications, and obtain recommended lupus screening labs and preventive care.
15865779|NCT03915639|Procedure|Peri-incisional injection|The surgeons are planned to inject the cocktail mixture or ropivacaine to muscles and the subcutaneous tissue beneath the fixation sites and incision site using a 22-gauge needle in a sterile fashion prior to skin incision.
15865780|NCT03915626|Drug|Rivastigmine (RLD) transdermal patch|brand name patch
15865781|NCT03915626|Drug|Rivastigmine (generic) transdermal patch|generic patch
15865782|NCT03915613|Drug|Humulin R|"The investigator and/or designee will instruct the study participant on how the intranasal insulin spray should be administered. Each study participant is to receive a single dose of Humulin R 160 U.
~The nasal spray bottles provide a deliverable volume of 0.1 mL/spray. Humulin R insulin will be sourced as 100 units/mL in a vials of 10 mL from Eli Lilly. 16 sprays in alternating nostrils (8 per nostril) will be administered per dose."
15865783|NCT03915613|Drug|Diluent|"The investigator and/or designee will instruct the study participant on how the intranasal placebo spray should be administered. Each study participant is to receive a single dose of placebo.
~The nasal spray bottles provide a deliverable volume of 0.1 mL/spray. Diluent will be sourced as 10 mL/vial from Eli Lilly. 16 sprays in alternating nostrils (8 per nostril) will be administered per dose."
15865784|NCT03915600|Other|Quinoa|Personalized diet added with quinoa
15865785|NCT03915600|Other|Flaxseed|personalized diet added with flaxseed
15882020|NCT03789214|Drug|Low Dose Suvorexant|Low Dose Suvorexant
15865787|NCT03915587|Device|CardioQ-EDM and CipherOx-CRI|A CardioQ-EDM probe will be placed on the day of surgery after induction of general anesthesia. The anesthesiologist will inform the investigator of plans to provide a fluid or blood bolus per clinical judgement in addition to the protocolized 10 ml/kg bolus provided after induction. While the anesthesiologist is preparing to administer volume expansion, a co-investigator will collect pre-fluid bolus data. Measurements will be recorded for data analysis at the completion of the trial. Additionally, a CipherOx-CRI probe will be placed on the patient's index finger (recorded data will be interpreted post hoc) and a bedside ultrasound will be performed by either the principal investigator (PI) or one of two co-investigators to measure the IVC CI. Ultrasound cine-loops will be recorded, and CI will be calculated post-hoc. Data will be recorded on the Data Collection Form for each fluid bolus administered. The PI and co-investigators will manage all aspects of investigational devices.
15865788|NCT03915574|Device|25G Dural Puncture Epidural|Dural puncture created with a 25 gauge spinal needle
15865789|NCT03915574|Device|Standard Epidural|Control group - standard epidural (no dural puncture)
15865790|NCT03915561|Drug|Parecoxib Injectable Product|Dynastat (parecoxib sodium) is rapidly converted to valdecoxib following injection and reduces the production of prostaglandins that are important mediators of pain and inflammation. After intravenous injection with 40mg Dynastat, the onset of analgesia was 7-14 minutes and reached a peak effect within 2 hours. After a single dose, the duration of analgesia was dose and clinical pain model dependent and ranged from 6 to greater than 24 hours and maximal daily dose of Dynastat is 80mg. According to recommendation of acute postoperative pain management and product information, the timing of first injection will be at 10 minutes before anesthetic induction, and second injection will be 6 to 12 hours after first injection.
15865791|NCT03915561|Drug|Normal saline|Placebo group (0.9% saline, group S) will be received intravenous injection with 10ml 0.9% saline alone (transparent solution) twice.
15865792|NCT03915548|Behavioral|The Behavioral Activation/ Problem Solving Intervention|The interventionist presents the rationale for BA/PS, promotes a positive problem orientation, and educates about the framework for problem-solving and action planning. The interventionist then administers the Canadian Occupational Performance Measure to elicit participant priorities, motivation, and long-term goals. The interventionist then guides the participant in using the BA/PS framework to set a goal, brainstorm solutions to challenges, and create a detailed action plan for the coming week.
15865793|NCT03915548|Behavioral|Attention Control Condition|The interventionist provides education regarding nine cancer survivorship topics (i.e., healthy diets, physical activity, lymphedema management, smoking cessation, stress management, communication with providers, body image and sexuality, communication with social supports, work accommodations) during the control telephone contacts.
15865794|NCT03915535|Dietary Supplement|Eicosapentaenoic acid + Docosahexaenoic acid|Monoglyceride Omega-3 fish oils
15865795|NCT03915535|Dietary Supplement|Eicosapentaenoic acid|Monoglyceride Omega-3 fish oil
15865796|NCT03915522|Procedure|Single adductor canal block|The operated leg is slightly externally rotated and prepared for a block with 2% chlorhexidine and sterile dressing. The adductor canal is identified using ultrasound image at the mid-thigh level and after a subcutaneous injection of 2 ml of 1% lidocaine a total of 20 ml of 0'5% ropivacaine is injected into the canal using a 22 gauge ultrasound-visible needle. In the end, a sterile apposite is placed at the puncture site
15865797|NCT03915522|Procedure|Simulated adductor canal block|The operated leg is slightly externally rotated and prepared with 2% chlorhexidine and sterile dressing. The adductor canal is identified using ultrasound image at the mid-thigh level and at this leve a subcutaneous injection of 2 ml of 1% lidocaine . After, a sterile apposite is placed at the puncture site.
15865798|NCT03915509|Device|Evaluation of the effect of surface properties on the stability of the different implants with resonance frequency analysis|Lasak Impladent Implants (sandblasted)
15865802|NCT03915483|Device|transcranial direct current stimulation (tDCS)|sham or real tDCS for 10 minutes of 1.5 milliampere (mA) tDCS targeting the prefrontal and the posterior parietal cortex
15865803|NCT03915470|Drug|XF-73|XF-73 is a dicationic porphyrin derivative having potent bactericidal properties with a novel mode of action.
15865804|NCT03915470|Drug|Placebo|Placebo to match XF-73 nasal gel for colour and viscosity.
15865805|NCT03915457|Other|Dry immersion Control Group|Subjects are immersed up to the neck for 5 days in a specially designed bath filled with tap water.
15865806|NCT03915457|Other|Thigh cuffs intervention|Subjects are immersed up to the neck for 5 days in a specially designed bath filled with tap water. During the 5 days of dry immersion, the subjects will wear the thigh cuffs daily for 10 hours during the day (8 am to 6 pm). Thigh cuffs are strips of fabric with inserts of elastic fabric. Different sizes exist to adapt to different thighs. Each cuff has five tightening positions (from 1 to 5) and they will be tightened at the upper third of the thighs to create an occlusion pressure of about 30 mmHg.
15865807|NCT03915444|Drug|nab-Paclitaxel + Cisplatin + Gemcitabine|"Cisplatin 25mg/m2 in 500 mL of NS over 60 minute IV infusion on days 1 and 8 repeated every 21 days.
~Gemcitabine 1000mg/m2 in 500 mL* over 30 minute IV infusion on days 1 and 8 repeated every 21 days.
~Post cisplatin hydration: IV fluids up to 1000 mL (with additives as clinically indicated) IV given as infusion on days cisplatin is administered on days 1 and 8 repeated every 21 days."
15865808|NCT03915431|Biological|NCS-01|single infusion
15865809|NCT03915431|Biological|Placebo|single infusion
15865810|NCT03915418|Procedure|Connected tools|At home, parents will record their child's sleep for 3 consecutive nights Then, on the date scheduled for the inclusion of the children and after the recording of the 3 nights at home, the child will spend a night in a hospital environment to carry out the recording by polysomnography and tools connected simultaneously.
15865811|NCT03915405|Drug|KHK2455|orally, once daily.
15865812|NCT03915405|Drug|Avelumab|IV Administration
15865813|NCT03915379|Drug|JNJ-67571244|JNJ-67571244 will be administered.
15865814|NCT03915366|Drug|Valganciclovir Oral Solution [Valcyte]|Treatment for CMV
15865815|NCT03915366|Drug|Tuberculostatic Agents|Treatment for tuberculosis
15865816|NCT03915353|Other|No Intervention|No Intervention
15865819|NCT03915327|Drug|Intravenous iron dextran|Enrolled subjects would receive intravenous iron dextran within 24 hours of the subject's inclusion.
15865820|NCT03915314|Diagnostic Test|Neuropsychological tests|The investigators do the neuropsychological tests, Mini-Mental score examination (MMSE),Charlson Comorbidity Index(CCI)，Quality of Recovery Score - 40 (QoR-40),CAGE Alcoholism Questionnaire,blood albumin、hemoglobin content、ALT、AST、BUN、Cr、1 day before the surgery（baseline);serum biomarkers of endothelial dysfunction，blood brain barrier disruption and neuronal injury to be measured at 2 time points,1 day before the surgery（baseline）and postoperative day 1； Confusion Assessment Method（CAM)，Numerical Rating Scale（NRS）once before discharge from PACU and 1、2、3 days after surgery twice a day； QoR-40 1 day after surgery.
15865821|NCT03915301|Procedure|Satisfaction assessed by the VAS [followed by its scale information in the Description]|Erector spinae plane block provided in thoracic part of spine, VAS scale 0-10
15865822|NCT03915288|Other|Group continuous training at moderate intensity|70 minutes for intervention, where 10 minutes were warm up (breathing exercises, walking, stretching), 30 minutes of continuous aerobic training at moderate intensity (60-80% FCM), with fast walking or endless tread with the floor inclined to reach the desired intensity. Also on bicycle, rowing and elliptical; Then, 20 minutes of strength training (40-60% maximum strength) with dumbbells and theraban. Ends with 10 minutes of cooling with walking and breathing exercises.
15865823|NCT03915288|Other|Group high Intensity Interval Training|70 minutes for intervention, where 10 minutes were for warm-up (Respiratory exercises, walking, stretching), 30 minutes consisted of an intensity of interval training. That is, the participants who underwent 30 minutes of aerobic exercise consisted of a protocol created for this experimental group that we named 30-30. 30 seconds at moderate intensity (60-80% FCM) and 30 seconds at high intensity (80-90%). ; Then, 20 minutes of strength training (40-60% maximum strength) with dumbbells and theraban. Ends with 10 minutes of cooling with walking and breathing exercises.
15865824|NCT03915288|Other|Group control|This group did not perform supervised exercise nor were they given exercise recipes or formal intervention programs. Only continued with the usual care and gave directions to maintain a healthy lifestyle based on proper nutrition and usual activities.
15865825|NCT03915262|Biological|Search for exocrine pancreatic insufficiency at week 0 and 12|"We will collect 24 hours stool to search for steatorrhea, and to measure elastase and calprotectin.
~We will collect a total of 8 additional blood tubes (25mL), during regular blood sampling for a patient under biological therapy for a Crohn's disease.
~We will gather the total caloric and fat intake with a diet record."
15865826|NCT03915236|Device|MON4STRAT Strategy|Meropenem infusion guided by daily Therapeutic Drug Monitoring (adjusted in order to reach predetermined PK/PD targets) using MON4STRAT device.
15865827|NCT03915236|Other|Control group|Meropenem 1 gram infused every 8 hours over 30 minutes, consistent with standard-of-care treatment and published guidelines. Meropenem doses will be modified according to SmPC recommendations.
15865828|NCT03915223|Drug|Solumedrol (steroidal anti-inflammatory drug)|Surgical leg fracture with injection of solumedrol (steroidal anti-inflammatory drug)
15865829|NCT03915197|Diagnostic Test|Pneumological evaluation|Consultation with a pneumopediatrician: collection of respiratory symptoms, respiratory treatments, evaluation of the atopic site and environmental risk factors for bronchial aggression, especially passive smoking
15865830|NCT03915184|Biological|CT053|A single autologous chimeric antigen receptor-B-cell maturation antigen (CAR-BCMA T cell) infusion
15865831|NCT03915171|Diagnostic Test|Next generation sequencing|NGS can provide genetic and MSI test for patients
15865832|NCT03915158|Procedure|bariatric surgery|sleeve gastrectomy
15865833|NCT03915145|Other|Kinesio tape application|Kinesio tape application will be performed.Taping is carried out from the estimated day of ovulation (cycle length in days minus 14) until the next menstrual period begins
15865834|NCT03915145|Other|Sham Kinesio tape application|Sham kinesio tape application will be performed. Sham taping is carried out from the estimated day of ovulation (cycle length in days minus 14) until the next menstrual period begins
15865835|NCT03915145|Other|No intervention|The natural process will be followed from the estimated day of ovulation (cycle length in days minus 14) until the next menstrual period begins
15865836|NCT03915132|Drug|Nimotuzumab|Nimotuzumab 200mg/m2 IV on d1 of a week before radiotherapy , and 100mg/m2 IV on d1 weekly for 7 cycles
15865837|NCT03915132|Radiation|VMAT|Intensity-modulated radiotherapy was given to the patients with regimen of 69.96 Gy-73.92 Gy to the gross target volume of nasopharynx,69.96 Gy to the gross target volume of positive nodes, 60.06 Gy the high risk clinical target volume, 50.96 Gy to the low risk clinical target volume.
15865838|NCT03915119|Other|GFT AI training|navigates a cluttered environment of stationary and moving/pursuing virtual obstacles to reach a way-point as quickly and efficiently as possible. Block order and difficulty, as well as the behavior of the obstacles in each block, will be driven by the AI and statistically weighted to specifically target the perceptual-motor and neuromechanical mechanisms based on each athlete's visit 1 performance
15865839|NCT03915106|Device|Brace|Wear a rigid brace
15865840|NCT03915106|Procedure|Surgical correction using implants|Surgical correction of spine using implants (metallic rods and metallic screws)
15865841|NCT03915093|Other|Educational nursing protocol|It is a booklet given to study group ,which contains Knowledge and practice about thoracoscopy, pre - post operative care and home care instructions
15865842|NCT03915093|Other|Routine hospital care|The routine care given by physicians and nurses after thoracoscopic surgery
15865843|NCT03915080|Drug|Oktokog alpha|adjusting dose and dose interval according to MyPKFIT
15865844|NCT03915067|Drug|BOTOX High Dose|BOTOX will be injected into the platysma muscle
15865845|NCT03915067|Drug|BOTOX Low Dose|BOTOX will be injected into the platysma muscle
15865846|NCT03915067|Drug|Placebo|Placebo will be injected into the platysma muscle
15865847|NCT03915054|Drug|AREG-TRIGGER|"Oocytes in AREG-TRIGGER medium will be mature in AREG + FSH + HSA + Insulin + Estradiol medium.
~Per case (6mL) 5940 µL Basal Medium
~60 µL IVM MIX Do not need to filtrate media."
15865848|NCT03915054|Drug|CONTROL-TRIGGER|"Oocytes in CONTROL-TRIGGER medium will be mature in FSH + hCG + GH + HSA medium.
~Per case (5 mL) 4.3 ml IVM Medicult Medium (Vial 2) 0.5 ml HSA (from stock 10% solution) 50µl FSH (from stock 7.5 IU/ml) 5µl hCG (from stock 100 IU/ml) 75 µl GH (from stock 0.66mg/ml)"
15866395|NCT03910595|Other|Mepitel Film|Mepitel film is a barrier film that may help in reducing radiation dermatitis by limiting friction.
15865849|NCT03915041|Device|VR + active brain stimulation|Active Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)
15865850|NCT03915041|Device|VR +sham brain stimulation|Sham Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)
15865851|NCT03915028|Other|Spa therapy|"The standardized treatment will consist of 4 spa treatments per day for 3 consecutive weeks.
~Each day, the patient receives at least four treatments, among which:
~Cure of Drink (in addition to 4 daily cares)
~Bath in running water: Bath
~Bath in running water: Pool at 32 ° C
~Bath with aerobain
~Immersion shower bath
~Shower of high pressure under immersion in swimming pool
~General penetrating shower
~General jet shower
~Local jet shower
~Local mud bath at the feet
~Single poultice
~Multiple poultice
~Compress
~Mobilization pool
~Massages under water"
15865852|NCT03915015|Diagnostic Test|MRI|MRI
15865853|NCT03914989|Other|olfactory enrichment (essential oils)|Participants will be exposed to either a higher or lower concentration of essential oils nightly for two hours as they are going to sleep, using a nebulizing fragrance diffuser, rotating through seven different scents, one per night.
15865854|NCT03914976|Procedure|patient having to undergo a high risk programmed digestive surgery|The objective is to determine if there is an association between the mean intraoperative values and within 24 hours postoperative ΔPCO2 and the occurrence of major post-operative complications at day 28 in high-risk surgery (major hepatectomy, esophagectomy or duodeno- cephalic pancreatectomy)
15865855|NCT03914963|Biological|Fibrin sealant hemipelvis|Following the manufacturer´s instructions, 5 ml of sealant was sprayed evenly across the entire surgical bed in only one hemipelvis (the treated hemipelvis) after pelvis bilateral lymphadenectomy.
15865856|NCT03914963|Biological|Control hemipelvis|Contralateral hemipelvis not treated with fibrin sealant
15865857|NCT03914950|Diagnostic Test|PET/CT results with TOF/without TOF|"Diagnostic CT of the abdomen or upper abdomen with parenteral contrast medium (Visipaque=Iodixanol) if creatinine, GFR, and TSH levels are within the normal range and oral (water) contrast medium within TOF-18F-FDG PET/CT. In the case of elevated creatine or decreased GFR or TSH levels a diagnostic CT of the abdomen or upper abdomen without contrast medium is performed.
~Biopsy or FNA or operation of the pancreas."
15865858|NCT03914937|Other|Virtual reality|A virtual reality device will be worn over the eyes that allows the patient to feel that they are at a quiet seaside beach.
15865859|NCT03914937|Other|Music|Music of the patient's choice will be played
15865860|NCT03914924|Behavioral|Exercise Program|"The 12-week program consisting of 16 exercise sessions in a total of supervised and individually prescribed aerobic and muscle-strengthening exercise of approximately 60 minutes duration. The exercise sessions will be delivered as follow:
~4 weeks - supervised exercise sessions 2x / week
~8 weeks - supervised exercise sessions 1x / week
~In addition, they will receive counseling for unsupervised exercise sessions in their community, to accumulate a minimum of 150 min/week."
15865861|NCT03914924|Behavioral|Lifestyle Education Program|"The 12-week program consisting of 18 education classes of 30 minutes duration delivery by a health educator team. Participants receive a comprehensive education workbook to accompany the sessions, containing 20 chapters. The classes will be delivered as follow:
~initial class to program introduction
~4 weeks - education classes 2x / week
~8 weeks - education classes 1x / week
~final class to program graduation"
15865862|NCT03914911|Device|Smart Biopsy Device|The radiologist will perform a routine ultrasonic guided biopsy procedure using the smart biopsy system, with the device readings not visible (i.e. the radiologist will be blinded to device readings)
15865863|NCT03914898|Other|Nurse led intervention group|This program is based on cognitive restructuring tecniques.
15865864|NCT03914885|Genetic|ATLCAR.CD30|Administered at a dose of 2 x 10^8 cells/m2
15865865|NCT03914885|Drug|Bendamustine|Administered as a dose of 70mg/m2/day over 3 consecutive days; maybe dose reduced per treating physician discretion based on prior toxicities and the patient's clinical status
15865866|NCT03914885|Drug|Fludarabine|Administered at a dose of 30mg/m2/day over 3 consecutive days; given concomitantly with bendamustine
15865867|NCT03914872|Biological|Neoantigen DNA Vaccine|The schedule for vaccination will be weeks 1, 5, 9, 13, 17, and 21. All vaccines will occur within +/- 1 week with at least 3 weeks between vaccines.
15865868|NCT03914872|Device|Integrated electroporation device|"Ichor Medical Systems
~All study injections will be given intramuscularly using an integrated electroporation device"
15865869|NCT03914859|Biological|IN VITRO FERTILIZATION|Using exposure biomarker as a reliable means of evaluating gamete quality to estimate the chances of success in in vitro fertilization.
15865870|NCT03914846|Procedure|Ultrasound|Undergo ultrasound with elastography
15865871|NCT03914833|Other|Inclusion Questionnaires|During the inclusion visit, neuropsychologist tests the scales: SCAT3 (Sport Concussion Assessment Test 3ème version), Trail-making test (TMT), Wechsler Adult Intelligence Scale (WAIS) TAP, HAS (Hospital Anxiety and Depression scale) ; PSQI (Pittsburg Sleep Quality Scale) ; RPQ (Rivermead Post concussion symptoms Questionnaire) ; and RHFUQ (Rivermead head injury follow-up questionnaire)
15865872|NCT03914833|Other|Questionnaires at inclusion, M1 and M3|During the inclusion visit, the 1-month visit and the 3-month visit; neuropsychologist grading of the scales: SCAT3 (Sport Concussion Assessment Test 3ème version), Trail-making test (TMT), Wechsler Adult Intelligence Scale (WAIS) TAP, HAS (Hospital Anxiety and Depression scale) ; PSQI (Pittsburg Sleep Quality Index) ; RPQ (Rivermead Post concussion symptoms Questionnaire) ; and RHFUQ (Rivermead head injury follow-up questionnaire)
15865873|NCT03914820|Procedure|HIPEC CO2|Prophylactic surgery plus HIPEC CO2 performed with mitomycin
15865874|NCT03914820|Procedure|Standard surgery|Standard surgery without HIPEC CO2
15865875|NCT03914807|Other|Whole (3.25%) cow's milk recommendation|Children randomized to the whole milk recommendation will receive a recommendation a primary care recommendation to consume 500 mL of whole fat (3.25%) milk instead of transitioning to reduced fat (1%) milk at 2 years of age. The primary care physician will verbally make this recommendation during the recruitment well-child visit. Parents will also be reminded bi-monthly by phone calls made by a research assistant. Children in the whole milk recommendation group will be provided with the same age-appropriate nutritional recommendations as children in the reduced fat recommendation group as part of routine healthcare according to the Rourke Baby Record.
15866025|NCT03913611|Other|Accelerated rehabilitation protocol|Patients in this group will undergo an accelerated rehabilitation protocol, without movement restrictions. Movement restriction will instead be governed by patient comfort.
15865876|NCT03914807|Other|Reduced (1%) fat milk|Children randomized to the reduced fat group will receive a primary care recommendation to transition from whole milk to 500 mL reduced fat (1%) milk daily once the child is two years of age (consistent with current guidelines). The physician will verbally make this recommendation during the recruitment well-child visit. Parents will also be reminded bi-monthly by phone calls made by a research assistant. Children who receive the reduced fat recommendation will be provided with the same age-appropriate nutritional recommendations as children who receive the whole fat recommendation as part of routine healthcare according to the Rourke Baby Record.
15865878|NCT03914781|Behavioral|SPIN-SELF Program|The SPIN-SELF program utilizes social modelling through educational videos of scleroderma patients who describe their own challenges and what they have done to cope with living with scleroderma, as well as videos of patients and health professionals who teach key self-management techniques. The program includes sections on general self-management skills, including goal-setting and self-monitoring), progress tracking, sharing goals and progress with friends and family, and patient stories of experiences with using self-management techniques to cope with SSc symptoms. The program's 9 modules focus on (1) coping with pain; (2) skin care, finger ulcers and Raynaud's; (3) sleep problems; (4) fatigue; (5) gastrointestinal symptoms; (6) itch; (7) managing emotions and stress; (8) coping with body image concerns due to disfigurement; and (9) effective communication with healthcare providers.
15865879|NCT03914768|Biological|Immunomodulatory DC vaccine to target DIPG and GBM|This study will inject DC vaccine cells near lymphoid tissue close to the tumor. The patient will receive intravenous cyclophosphamide (200 mg/m2) or oral (cytoxan) before the vaccine, followed by DC vaccine and intravenous bevacizumab (15 mg/kg) the next day. The cells will be repeatedly infused every month for six consecutive months depending on the response and the condition of the patient. The amount of DC vaccine cells per injection is based on prior report at 5-10x106. An initial dose escalation scheme will be imposed.
15865880|NCT03914755|Drug|Tucatinib|Administered via oral tablet
15865881|NCT03914742|Drug|PARP Inhibitor BGB-290|Given PO
15865882|NCT03914742|Drug|Temozolomide|Given PO
15865883|NCT03914742|Procedure|Therapeutic Conventional Surgery|resection surgery
15865884|NCT03914729|Procedure|Primary Closure|A symmetrical elliptical incision of skin and subcutaneous fat around primary and secondary orifices is performed. The cyst is excised en bloc down to the sacral fascia and removed. The lateral edges of the wound are approximated and sutured in the midline: subcutaneous fat - with a running suture, skin - with a separate running suture.
15865885|NCT03914729|Procedure|Gluteus Maximus Fascia Plasty Flap|A symmetrical elliptical incision of skin and subcutaneous fat around primary and secondary orifices is performed. The cyst is excised en bloc down to the sacral fascia and removed. The lateral edges of the gluteus maximus muscles fascia bilaterally are mobilised in the direction from the fixation point to the sacrum and for 3-4 cm in lateral direction. The fascia flaps edges are approximated and fixed in the midline with a running suture. The subcutaneous fat is closed with a running suture, skin is closed with a separate running suture.
15865886|NCT03914716|Diagnostic Test|Study group|Subjects will have physical, imaging examinations and provide samples for biological markers
15865887|NCT03914703|Procedure|EZ Pass Suture Passer|Instruments used to help with rotator cuff or ACL repair
15865888|NCT03914690|Drug|Erythropoietin|EPO is administered 500IU/kg, intravenously after diagnosis of IVH within 72h after birth, and every other day for 2 weeks.
15865889|NCT03914690|Drug|Normal saline|Normal saline is administered the same volume with EPO, intravenously after diagnosis of IVH within 72h after birth, and every other day for 2 weeks.
15865890|NCT03914677|Drug|Mecamylamine Oral Tablet|nicotinic antagonist (ganglionic blocker)
15865891|NCT03914664|Diagnostic Test|Electroencephalogram (EEG) testing procedure|EEG testing procedure, comprised of somatosensory and auditory event-related potential paradigms, as well as resting state EEG
15865892|NCT03914651|Drug|300IU rFSH Gonal-F® starting dose during controlled ovarian stimulation|On menstrual cycle day 2 or day 3, 300IU rFSH Gonal-F® will be administrated daily till the day of trigger. The dosage of rFSH can be adjusted only if there is a risk of ovarian hyperstimulation syndrome（OHSS）.
15865893|NCT03914651|Drug|150IU rFSH Gonal-F® starting dose during controlled ovarian stimulation|On menstrual cycle day 2 or day 3, 150IU rFSH Gonal-F® will be administrated daily till the day of trigger. The dosage of rFSH can be adjusted only if there is a risk of OHSS or insufficient follicular growth.
15865894|NCT03914638|Drug|Salbutamol 4Mg Tablet|Salbutamol 4 mg, three times daily
15865895|NCT03914638|Drug|Placebo oral capsule|Placebo, three times daily
15865919|NCT03914586|Device|oXiris filter|Continuous Renal Replacement Therapy with oXiris filter
15865920|NCT03914560|Other|Burn injury|minor burn injury
15865921|NCT03914547|Behavioral|REDCHiP|REDCHiP includes seven group-based sessions and three individual sessions. REDCHiP uses a three-pronged approach to reduce parents' FH. It uses T1D education and problem-solving to enhance parents' knowledge and skills. It uses child age-appropriate behavioral parent training to promote parents' skills and confidence in managing disruptive child behaviors and reducing their reliance on hypoglycemia avoidance behaviors. It uses cognitive-behavioral therapy strategies to help parents reduce maladaptive thinking/coping related to hypoglycemia fear.
15865922|NCT03914547|Behavioral|ATTN|Provides a similar attention control. ATTN includes seven group-based sessions and three individual sessions.
15865923|NCT03914534|Drug|Valproic Acid 500 MG|Administration of 500 mg of Valproic Acid
15865924|NCT03914534|Drug|Valcote 500 mg|Administration of 500 mg of Valproic Acid
15865925|NCT03914508|Behavioral|Memory + Behavioral Weight Loss|BWL and memory enhancement (M+BWL) will be integrated to capitalize on the strengths of both treatments. All participants will be taught general behavioral weight loss skills including to decrease caloric intake and increase physical activity, self-monitoring, goal setting, managing high-risk situations, meal planning, slowing eating, problem solving, social support, cognitive restructuring, lapse and relapse prevention skills, and maintaining weight loss. The proposed M+BWL program provides memory interventions based on the literature, including eating attentively, memory of previous meal, memory skills for planning, effects of diet on memory and the relationship between memory and satiety. The M+BWL program will also utilize experiential learning during the group program such as practicing memory enhanced skills during eating.
15865926|NCT03914495|Dietary Supplement|Inulin|Powdered inulin will be provided in pre-weighed portions for consumption in a 1 week titration to reduce GI side effects with a 21 day intervention at full dose.
15865927|NCT03914495|Dietary Supplement|Placebo|Powdered maltodextrin will be provided in pre-weighed portions for consumption in a 1 week titration with a 21 day intervention at full dose.
15865928|NCT03914482|Device|MRI|The device will acquire thermoacoustic data while the ultrasound probe acquires ultrasound images, and an MR of the liver is acquired as a comparative modality
15865929|NCT03914469|Behavioral|Behavioral Intervention Group|The active intervention will include eight tele-delivered health coach sessions, three tele-based outcome assessments, and up to two semi-structured interviews at 6 months post-intervention. Each tele-based outcome assessment is roughly 45-60 minutes and will be conducted by a member of the research team. Each intervention session will be delivered by a trained health coach over a period of 10-20 weeks (up to 5 months total, accounting for additional time between sessions if needed).
15865930|NCT03914456|Other|rehabilitation treatment|
15865931|NCT03914443|Biological|Nivolumab|240 mg or 360 mg
15865932|NCT03914443|Drug|5-FU|750 or 800 mg^2
15865933|NCT03914443|Drug|CDDP|70 or 80 mg/m^2
15865934|NCT03914443|Drug|DTX|70 mg/m^2
15865935|NCT03914430|Other|Food|The intervention represents a breakfast meal (cereals with cultured products) or breakfast skipping (water control)
15865936|NCT03914417|Drug|Imiquimod 3.75% Cream|Approximately two weeks after Day 0, the entire treatment area was treated with imiquimod 3.75% cream. Subjects utilized the 2 weeks on, 2 weeks off, 2 weeks on regimen. Subjects were followed every 2 weeks during treatment (week 2, 4 and 6) and then at 4 and 8 weeks post last-imiquimod application (week 10 and 14).
15865937|NCT03914404|Drug|γ-linoleic acid and placebo(Thioctic Acid)|"γ-linoleic acid (Evoprim soft capsule) twice a day and 4 capsules at a time.
~Thioctic Acid(LipoA HR Tab. 600mg) placebo once a day and 1 tablet at a time."
15865938|NCT03914404|Drug|Thioctic Acid and placebo(γ-linoleic acid)|"Thioctic Acid(LipoA HR Tab. 600mg) once a day and 1 tablet at a time.
~γ-linoleic acid (Evoprim soft capsule) placebo twice a day and 4 capsules at a time."
15865939|NCT03914365|Procedure|Ultrasound-guided pudendal nerve block (PNB) and Ultrasound-guided penile nerve block (DPNB)|Our primary objective is to compare analgesia between the two blocks during and after pediatric circumcisions to minimize post-operative pain.
15865940|NCT03914352|Drug|PD-1 antibody|In this group participants were treated with PD-1 antibody (240mg, Intravenous drip infusion, Q14 days) since the15 days after hepatic resection and at the interval of 15 days.
15865941|NCT03914352|Procedure|TACE|In this group enrolled patients were treated with TACE at the30 days after hepatic resection.
15865942|NCT03914339|Procedure|Periodontal and orthodontic treatment|Eighteen periodontally compromised patients who give be given both periodontal and orthodontic treatment
15865943|NCT03914339|Procedure|periodontal treatment|Eighteen periodontally compromised patients who give be given periodontal treatment alone.
15865944|NCT03914326|Drug|Semaglutide|Increasing doses (3 mg/7 mg/14 mg) of semaglutide tablets to be taken with water at the same time every morning in a fasting state
15865945|NCT03914326|Drug|Placebo (semaglutide)|Placebo tablets to be taken with water at the same time every morning in a fasting state
15865946|NCT03914313|Device|Robotic Treatment plus VR|The patients included will be divided into three groups of 30 patients each. In this group patients will undergo a rehabilitation training with the Lokomat-Pro, in which the exoskeleton device is equipped with a screen with virtual reality. The rehabilitation protocol consists of 24 training sessions (3 sessions per week, for 8 weeks, each session lasting about 45 minutes). The Lokomat-Pro will be used to improve gait, whereas motor and cognitive function will be normally trained by using conventional neurorehabilitation. Patients will be evaluated at baseline (T0), immediately (T1) and after 3.month (T2) of treatment.
15865950|NCT03914287|Other|Self-Myofascial release|The Self-Myofascial release protocol for the lower limbs using a Foam Roller will include: Self-Myofascial release of the plantar region using and Solid Ball Massage; release of the myofascial components of the back of the leg using a Foam Roller; release of the myofascial components of the anterior part of the leg using a Foam Roller; release of myofascial components of the hamstring region using a Foam Roller; release of the myofascial components of the adductor muscles using a Solid Ball Massage in a sitting position; release of the myofascial components of the abductor muscles using a Foam Roller in lateral decubitus; and release of the myofascial components of the pelvitrochanteric muscles using a Foam Roller in a sitting position.
15866026|NCT03913611|Other|Traditional rehabilitation protocol|Patients in this group will undergo a traditional rehabilitation protocol, with movement restrictions and sling use for 6 weeks following surgery.
15865951|NCT03914274|Device|Technical sock|Socks were of two types: technical socks, designed for high performance sports use (Lurbel brand, models Tierra and Set), and non-technical socks for everyday use. The socks had different composition: Tierra (50% regeneractiv, 25% cool-teak, 17% polyamide ions, 8% lycra); Set (75% cotton, 17% polyamide, 8% lycra) and cotton (98% cotton, 2% elastane).
15865952|NCT03914261|Drug|Risankizumab|Tablet
15865953|NCT03914235|Combination Product|Tumescent Anesthesia|A tumescent solution is prepared with 2% lidocaine (10ml), 1:1000 epinephrine (0.4ml) and 7.5% sodium bicarbonate (4ml) dissolved in 0.9% saline solution (40ml) and applied from 3 to 20ml (depending on the pathology to be repaired) at the incision site.
15865954|NCT03914235|Drug|Lidocaine|Apply 3 to 20 ml at the incision site, depending on the pathology to be repaired(carpal tunnel syndrome, trigger finger or Quervain syndrome).
15865955|NCT03914235|Device|Pneumatic tourniquet|Level of the forearm at 250 mmHg, after exsanguination with Esmarch bandage.
15865956|NCT03914235|Procedure|Open release of the tendon|Standard surgical procedure for carpal tunnel syndrome, trigger finger and Quervain syndrome.
15865957|NCT03914222|Device|CardioSpire (Respirix) Device|Patients will blow into the device through a small tube, which analyzes the signals in the airway patterns.
15865958|NCT03914209|Other|EHL clotting factor|This study shall not implement any intervention that might alter the normal development of the daily life activities of hemophilia patients included in the study. They will continue with the prophylactic regimen prescribed by their hematologist. Patients will also be asked to continue to develop their physical, work, entertainment and leisure activities in the same way as at baseline.
15865959|NCT03914196|Diagnostic Test|Liver Stiffness Ultrasound|Research imaging will include liver assessments of stiffness (ultrasound shear wave elastography), tissue attenuation (if available), and blood flow (gray-scale and Doppler imaging).
15865960|NCT03914183|Device|mCPN Intervention|"Each box of montméd Coloured Pen Needles (mCPN) has the following five features:
~i. Distinctively coloured pen needles ii. A user-defined association tool which is intended to help the patient associate each colour to a specific injection zone iii. A concise and intuitive educational message Change color, change site siteTM iv. Unique packaging with educational content v. Four distinctive message-in-a-box educational sound-chips which serve to reinforce the recommended educational message on site rotation at home and come on every tenth time the pen needle box is opened"
15865961|NCT03914183|Device|Control|Use of standard of care insulin pen needle
15865962|NCT03914170|Drug|Folfirinox + cetuximab|Cetuximab 250 mg/m² iv infusion for 2h, Oxaliplatin 85 mg/m² administered as an iv infusion for 2h Elvorine 200 mg/m² administered as an iv infusion for 2h, Irinotecan 180 mg/m² iv infusion, 5FU 400 mg/m2 bolus then 5FU 2,400 mg/m² iv infusion for 46h D1=D15 (12 cycles max)
15865963|NCT03914157|Device|Low-energy extracorporeal ultrasound shockwave therapy (SWT)|SWT delivers 10% energy of the traditional SWT used for clinically indicated lithotripsy, evokes neovascularization, and improves regional blood flow and function in various ischemic tissues.
15865964|NCT03914144|Other|Catheter insertion|A data collection sheet will be assigned for every patient who is recruited for the study. The clinician caring for the patient will be asked to fill in this form after the delivery has occurred. The form essentially will describe if the patient received any catheter during the delivery and if so, an indwelling catheter or an intermittent (in/out) catheter and how many episodes this occurred.
15865965|NCT03914131|Drug|Xinnaoning Capsule|Xinnaoning Capsule used in study group(treatment period) is the true drug that the investigators are to evaluate.
15865966|NCT03914131|Other|Xinnaoning Capsule Simulator|Xinnaoning Capsule Simulator used in control group and introduction period(both groups) is the placebo to reduce the risk of bias.
15865967|NCT03914118|Drug|Preoperative modafinil + postoperative placebo|200 mg modafinil pre-operatively and placebo immediately post-operatively.
15865968|NCT03914118|Drug|Preoperative modafinil + postoperative modafinil|200 mg modafinil pre-operatively and 200 mg modafinil immediately post-operatively.
15865969|NCT03914118|Drug|Preoperative placebo + postoperative placebo|Placebo pre-operatively and placebo immediately post-operatively.
15865970|NCT03914105|Procedure|Without music|"The starting condition will be without music: the subjects, after a rest period of 10 minutes, will perform a test of induced pain for 6 minutes. There will be no music for the duration."
15865971|NCT03914105|Procedure|With music|"The starting condition will be with music: the subjects, after a rest period of 10 minutes, will perform a test of induced pain for 6 minutes. There will be music for the duration."
15865972|NCT03914092|Drug|triamcinolone acetonide injection|,1 mm percutaneous intralesional injection
15865973|NCT03914092|Behavioral|Smith Accent method of voice therapy|regular sessions of smith accent voice therapy (about 24 sessions, twice session / week) for 3 months
15865974|NCT03914066|Behavioral|A group-based treatment of overweight and obesity|The intervention is a group treatment of overweight and obesity in primary care inspired by cognitive behavioural therapy. The main goal of the group treatment is for the participants to obtain and maintain healthy lifestyle habits, with emphasis on diet and physical activity. Every group has 8-12 participants and is led by two persons; the main group leader is either a primary care nurse or a physiotherapist with special training. The groups meet six times (2 hours every time) once a month over a 6-8 month period. Every group session has a set agenda with different topics, for example a healthy diet, recommended physical activity or how to deal with setbacks. Between group sessions there are home assignments. The home assignments are followed-up at the next session and participants are encouraged to share experiences with each other in order to inspire, challenge and help fellow group participants. Data is collected prior to the start of group treatment, after 6-8 and 12 months.
15865975|NCT03914040|Other|IPSE program|"Pre-immersion preparation. A self-study course will be offered about lifestyle modification. Some readings will be suggested to introduce students to the concepts of health promotion and prevention of metabolic syndrome.
~Immersion. Four different learning methods will be provided: I) four hours of didactic lectures followed by group discussion, II) four hours per student of role playing, III) 30' per students of standardized patient experiences and IV) 30' per students of a new immersive advanced simulation learning environment (e-REAL). Four case-studies will be used to create scenarious, including woman with menopause weight gain, obese young adult, obese child and adult with unhealthy behaviours."
15866027|NCT03913598|Other|patient questionnaire|self-administered patient questionnaire regarding the different aspects of internet and social media use in dermatology patients
15865976|NCT03914027|Behavioral|Telerehabilitation|"Each patient will have the opportunity to have minimum one VC per week the first month, one Video Consultation each second week the second month one VC a month the rest of the trial. Here the physiotherapist, via history will extract the information needed to calibrate the daily TR program according to the patient's physical status and needs.
~Workout Sessions with a Virtual Physiotherapist Agent (VPA): The patient will train according to what is decided by the physiotherapist and the patient in the VC or chat meetings. Normally, the patients will train 10-20 minutes daily at home with its individual and tailored VPA. Instead of ergometer bike training, the patient will receive some easy training tools such as elastics, weights and a fitness-step that can be used in the different exercises showed by the VPA to reach the same intensity of workout. The VPA will then be animated to motivate and encourage the patient to exercises at home."
15865977|NCT03914014|Other|connective tissue manipulation|From the estimated date of ovulation to the onset of menstrual bleeding, connective tissue massage will be applied to the sacral, lumbar, lower thoracic and anterior pelvic regions for 5 days per week. The application will take 10 min. During the massage treatment, the physiotherapist will touch the end of the middle finger with the skin of the patient and apply the skin to the pull. The patient will be in the supine position during the treatment of the anterior pelvic region while the patient is in the sitting position during the treatment of the back area.
15865978|NCT03914014|Other|placebo ultrasound|From the estimated date of ovulation to the beginning of the next menstrual bleeding, placebo ultrasound will be applied a total of 10 minutes (5 minutes for sacral and lumbar, and lower thoracic regions and 5 min for the anterior pelvic region). Placebo ultrasound application will be performed with superficial circular movements without applying excessive pressure. During the application, the device will only be switched on, the dose will not be adjusted and the patient will be given an image of ultrasound dose.
15865979|NCT03914001|Device|mpMRI|all eligible patients will undergo mpMRI 4 weks after initial TURBT
15865980|NCT03914001|Procedure|Second look TURBT|after mpMRI all patients will subjected to second look TURBT
15865981|NCT03913988|Behavioral|Lucid Dream|Lucid dream techniques are a set of strategies to induce the ability to obtain conscious awareness during the dream state and include mental suggestions before sleep.
15865982|NCT03913988|Behavioral|Stress Reduction|Stress reduction techniques are a set of strategies designed to reduce anxiety and include meditation and guided imagery.
15865983|NCT03913988|Behavioral|Sleep Hygiene Techniques|Sleep hygiene is a set of techniques intended to enhance sleep quality and quantity and include maintaining consistent sleep-wake times and avoiding stimulating activities before bed.
15865984|NCT03913975|Other|Neuromuscular training|The novel training program with real-time biofeedback added consists of 2 sets of 10 repetitions per session with a progression in exercise intensity (Squat: 40 repetitions during week 1; Squat Jump: 80 repetitions during weeks 2-3; Tuck Jumps: 120 repetitions during weeks 3-6) over the 6-week training period.
15865985|NCT03913962|Other|indirect calorimetry|Patients will be separated in different subgroups. Subgroups will be constituted according the disease status (i.e. active vs inactive) to assess the impact of the pathology on physical fitness and according to treatments to assess the effect of treatment on physical fitness.
15865986|NCT03913949|Drug|APG-2575|Multiple dose cohorts, PO, every day (QD) of a 28-day cycle
15865987|NCT03913936|Other|YES portal|The YES portal is designed to collect and assess participants' toxicities and symptoms, as well as informational needs in between visits with their clinician
15865988|NCT03913923|Biological|BCD-217|Combination of anti-CTLA-4 and anti-PD-1 monoclonal antibodies, 1mg/kg and 3 mg/mg, respectively, given Q3W as IV infusion
15865989|NCT03913923|Biological|BCD-100|Anti-PD-1 monoclonal antibody, 1 mg/kg, given Q2W as IV infusion
15865990|NCT03913923|Other|Placebo|Placebo
15865991|NCT03913910|Procedure|Lipogems|Autologous micro-fragmented adipose tissue is injected in the internal orifice, mucosal, submucosal and muscular layer, then in the fistula tract and external orifice in addition to anal flap.
15865992|NCT03913897|Other|distraction methods|The children in the groups were distracted by virtual reality goggles and kaleidoscope 2 minutes before venipuncture, until the process was over
15865993|NCT03913884|Procedure|Concentrated growth factor|CGF fibrin matrix was placed in one socket which was randomly selected (test side). The flap was sutured with 4/0 atraumatic silk suture (½ cutting edge, 75 cm, Doğsan, İstanbul, Turkey) for each surgical site.
15865994|NCT03913884|Other|Non-Concentrated growth factor Group|To control group, extraction of the tooth on the opposite site was performed and the socket left to heal naturally. The flap was sutured with 4/0 atraumatic silk suture (½ cutting edge, 75 cm, Doğsan, İstanbul, Turkey) for each surgical site.
15865995|NCT03913871|Behavioral|Texts to support healthy eating|The intervention arm will receive tailored text messages to encourage healthy eating (increase consumption, fruits, vegetables and water; and a reduce intake of sugar sweetened beverages). Participants will receive an average of 1-2 messages per day for 4 weeks.
15865996|NCT03913871|Behavioral|Texts to support physical activity|The intervention arm will receive tailored text messages to support increased minutes of physical activity per day. Participants will receive an average of 1-2 messages per day for 4 weeks.
15865997|NCT03913858|Procedure|Obesity Surgery with Low-Flow Anesthesia|Group 1 had 1 liter/minute (50% O2, 50% air) flow administered.
15865998|NCT03913858|Procedure|Obesity Surgery with High-Flow Anesthesia|Group 2 had 4 liter/minute (50% O2, 50% air) flow administered.
15865999|NCT03913845|Drug|lidocaine with epinephrine|One of the most commonly used local anesthetic agents in surgical practice is lidocaine. Lidocaine as a local anesthetic is characterized by a rapid onset of action (typically within 2-5 minutes of injection) and intermediate duration of efficacy and thus is often favored in the outpatient setting for pre-incisional injections. Of note, however, its effects general only last up to 2 hours. Epinephrine (adrenaline) vasoconstricts arteries, delaying the resorption of lidocaine, and thus almost doubles the duration of anesthesia.
15866058|NCT03913377|Device|ACUVUE OASYS®1-Day with HydraLuxe™ Technology|Test 1
15866059|NCT03913364|Dietary Supplement|Probiotic|B. bifidum 900791-containing ice cream
15866060|NCT03913364|Dietary Supplement|Placebo|Placebo ice-cream
15866061|NCT03913351|Behavioral|Lifestyle modification|The program consists of education on glycemic index, balanced diet, interpretation of food labels, food exchanges, healthy eating out techniques and healthy cooking methods.
15866490|NCT03909802|Other|Usual care|Usual care
15866000|NCT03913845|Drug|Normal saline with epinephrine|Several mechanisms could explain the inability to void postoperatively, including nerve conduction impairment from anesthesia. Multiple studies have investigated the use of various types of anesthesia and downstream effects on postoperative urinary retention. It is postulated that denervating the regional pelvic nerves for pain control may lead to denervation of the bladder for a transient period of time, block both the afferent and efferent pathways of the voiding mechanism, affect the urethral retro-resistance pressure and impact urethral length thereby contributing to voiding dysfunction postoperatively. The use of normal saline in this setting may have a reduction in rates and duration of postoperative urinary retention following retropubic midurethral sling placement.
15866001|NCT03913832|Device|sirolimus drug coated balloon (SCB)|"Magic TouchTM (Concept Medical) is a sirolimus drug coated balloon (SCB) for PCI, based on a polymer-free and Nano based drug delivery technology. Magic Touch SCB is a product of CMI proprietary drug delivery technology Nanolute. It is indicated (CE approved) for ISR, small vessels, bifurcation lesions & de novo lesions."
15866002|NCT03913832|Device|paclitaxel releasing coronary balloon catheter|SeQuent PleaseTM (B. Braun Melsungen AG, Vascular Systems,Berlin, Germany) is a paclitaxel releasing coronary balloon catheter.
15866003|NCT03913819|Drug|First line treatment: oral NSAID and anticholinergic agents|oral NSAID and anticholinergic agents
15866004|NCT03913819|Drug|Second line treatment: additional treatment for pain control|Gabapentin, tramadol, Lyrica
15866005|NCT03913819|Drug|Third line treatment: A course of intravesical hyaluronate will be given.|A course of intravesical hyaluronate will be given.
15866006|NCT03913819|Procedure|Fourth line treatment: surgical intervention|Consideration of hydrodistention and augmentation cystoplasty
15866007|NCT03913806|Drug|Bevacizumab-IRDye800CW|dose finding:10mg; 25mg; 50mg
15866008|NCT03913793|Other|Exercise based-cardiac rehabilitation (EB-CR) program|The exercise group underwent an outpatient EB-CR program (phase II) according to the American College of Sports Medicine guidelines for exercise prescription for cardiac patients.[19] Sessions were 3 days/week for 8 weeks. The program included: (1) Warm up (10 minutes): stretching exercises. (2) Aerobic exercise training using treadmill (30 - 60 minutes/session): with target heart rate (HR) at 45 - 75% of HR reserve. The maximal HR (HR max) was derived from that obtained during exercise stress test (EST). Patients who had ischemic/arrhythmic manifestations during EST, exercise intensity was prescribed at a HR below the ischemic threshold (10 beats below). (3) Cool down (10 minutes): light intensity treadmill walking. Supervision was provided according to the risk status of each patient that was determined according to the American Association of cardiovascular and Pulmonary Rehabilitation criteria for risk stratification.
15866009|NCT03913780|Other|Aerobic exercise more force|The work force for aerobic exercise is 50 to 70% of your maximum heart rate (HRM) achieved in the stress test according to the Naughton protocol. For strength, between 30% to 50% of 1 RM was determined, prolonging a percentage of heart rate that did not surpass 70% of the FCM nor the subjective uptake of physical effort to more than 6 on the modified Borg scale.
15866010|NCT03913754|Other|Psycho-social consequences of lupus erythematosus|It will be necessary to take into account the psychosocial experience of the disease [47] and to allow a narrative exploration of this experience and its psycho-social consequences both for the patients and their spouses (ie the experiential dimension of the disease in connection with the life trajectory, the life of a couple, elaborate representations concerning the disease). The purpose of this approach is not only to question the meaning of the disease (beliefs, representations), the psycho-social management of the disease, its inclusion in the socio-cultural condition of the patients, but also to allow an analysis of the inscription. of the disease in the relationship and its implications (relational, affective, sexual) and its impact on the possibilities of social participation.
15866011|NCT03913741|Drug|tisotumab vedotin|Tisotumab vedotin will be administered intravenously once every 21 days. The dose levels will be determined by the starting dose and the escalation steps taken in the trial
15866012|NCT03913728|Other|Drug level blood tests|All information included previously.
15866013|NCT03913728|Other|Telephone Interview|All information included previously.
15866014|NCT03913715|Behavioral|Ostomy Self-Management Training|include the dose and intensity of the intervention in the description, if applicable
15866015|NCT03913702|Drug|Ketorolac Tromethamine|2ml of injectable Ketorolac (30mg/ml) will be mixed with 8ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 60mg of active substance in 10ml).
15866016|NCT03913702|Drug|Methylprednisolone Acetate|1ml of injectable Methylprednisolone (80mg/ml) will be mixed with 9ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 80mg of active substance in 10ml)
15866017|NCT03913689|Device|StimRouter Neuromodulation System|An implantable neuromodulation device that treats chronic peripheral nerve pain.
15866018|NCT03913676|Behavioral|Velibra|"Velibra is grounded in a cognitive-behavioral theoretical orientation and consists of six treatment modules representing different skills and therapeutic techniques. Each of the first five modules is followed by a training session, and contains activities related to training attention biases (CBM-I). All sessions plus trainings are designed to be completed in 1 - 2 hours, depending on the user's reading speed, interest, motivation, and individual path through the program. The modules cover a variety of therapeutic content that is broadly consistent with a cognitive-behavioral perspective. The modules' content draws from therapeutic strategies: (1) Cognitive Modification, (2) Mindfulness, Acceptance, and Relaxation techniques (4) Exposure, (5) Interpersonal Skills, (6) Psychoeducation and Relapse Prevention."
15866019|NCT03913663|Other|vestibuloocular training|using vestibulo ocular training program for training neglect patient
15866020|NCT03913663|Other|regular exercise training for hemiplegic patients|Traditional gait training program.
15866021|NCT03913650|Procedure|0.25% bupivacaine|nerve block procedure will be decided by patients' will for post-op pain
15866022|NCT03913637|Behavioral|Strategy Training|Occupational therapists deliver Strategy Training to older adults virtually. Strategy training optimizes engagement in meaningful daily activities through generating self-selected goals, monitoring daily activities, scheduling activities, and problem-solving solutions to barriers experienced when engaging in activities.
15866023|NCT03913637|Other|Enhanced Usual Care|In this comparison condition, usual care will be enhanced by connecting older adults with MCI to resources available to meet their needs, and notify appropriate physicians when required. Enhanced Usual Care provides a usual care comparison while providing the participants with close monitoring of changes in symptoms.
15866028|NCT03913585|Behavioral|Lifestyle intervention|Upon inclusion and consent all patients receive a questionnaire to estimate risk of disease and risk behavior. Information about lifestyle is systematically registered and collated with existing Electronic Patient Record (EPR) data and the patients risk of developing a lifestyle-related disease is estimated based on validated algorithms for risk of type-2 diabetes, cardiovascular disease and COPD (Stratification). All patients receive digital feedback including a personal health profile and targeted advice. Patients at high risk of lifestyle-related disease(s) are offered targeted prevention activities at the GP including a health examination and if needed a health dialog. Patients with health risk behavior are offered behavior counselling in the municipality and community health services, if necessary. Patients diagnosed with a lifestyle related disease and patients with a healthy lifestyle are not offered any further services.
15866029|NCT03913572|Procedure|Injection of adipose-derived stem cells into perianal fistula|The plastic surgery team will perform fat graft harvest. Tumescent solution will be infiltrated into the area of liposuction, generally the abdomen, flanks, or thighs. Approximately a00ml of liposuction aspirate will be retrieved. It will be washed and condensed down to about 5-25 ml of good-quality fat graft using the REVOLVE System by Acelity. This will then be loaded into a syringe fitted with an injection cannula. The colorectal surgeon will perform an exam under anesthesia and determine if any additional procedure such as ligation of fistula tract, fistulotomy, endorectal advancement flap, or seton placement/exchange is needed. Severity of disease at time of surgery will be recorded by the attending surgeon. Following any indicated procedure, the lipoaspirate will be injected into the soft tissues around the fistula tract.
15866030|NCT03913559|Drug|Inotuzumab ozogamicin|dose: 0.5 mg/m2 IV over 60 minutes, days: 1, 8 and 15 every 4 weeks (28 days per cycle) for up to 6 cycles.
15866031|NCT03913559|Drug|Methotrexate|Intrathecal (IT) therapy
15866032|NCT03913559|Drug|Hydrocortisone|Intrathecal (IT) therapy
15866033|NCT03913559|Drug|Cytarabine|Intrathecal (IT) therapy
15866034|NCT03913559|Drug|Diphenhydramine|1 mg/kg (max 50 mg) IV
15866035|NCT03913559|Drug|Acetaminophen|10 mg/kg (max 650 mg) PO x 1
15866036|NCT03913559|Drug|Methylprednisolone|1 mg/kg IV x 1
15866037|NCT03913546|Procedure|Spinal manipulative therapy|Participants in the actual spinal manipulative therapy group will be assessed through the activator basic method protocol. SMT will be performed with an Activator IV (Activator Methods International, Phoenix, AZ) setting the force at level 3 for the low thoracic spine (T7-T12), and level 4 for the lumbar spine and pelvis.
15866038|NCT03913546|Other|Sham spinal manipulative therapy|Participants in the sham SMT group will undergo a protocol identical to the actual one, with the exception that a sham mechanical thrust (force set at level 0) will be delivered to the targeted areas. In the force level 0 no excursion of the stylus occurs, but the instrument produces the same clicking sound as in the actual SMT condition
15866039|NCT03913533|Device|Heart rate assessment using the Neonatal Resuscitation Program 6-sec assessment method|Heart rate assessment using the Neonatal Resuscitation Program 6-sec assessment method At birth, the clinical team will place the stethoscope on the infant chest and calculate heart rate by listening to the heart beat for 6-sec and then compute the heart rate of the newborn infant.
15866040|NCT03913533|Device|Heart rate assessment using Tap-based smartphone application|At birth, the clinical team will place the stethoscope on the infant chest and calculate heart rate using a Tap-based smartphone application by tapping the screen for 3 beats at that time a heart rate will be displayed.
15866041|NCT03913520|Other|Outcome research|patients will undergo an evaluation of their outcome at 30 days postoperatively
15866042|NCT03913507|Device|Macroduct® Advanced Model 3710 SYS, Wescor|for each subject, both methods will be tested in order to compare the efficacy of the new sweat collection method (Macroduct® Advanced Model 3710 SYS, Wescor) to the method currently used in clinical routine.
15866043|NCT03913494|Device|Transoral Neurostimulation Device (Snoozeal)|Use of the Transoral Neurostimulation Device for 20 minutes, morning and night, every day for at least 4 weeks.
15866044|NCT03913481|Procedure|Acute normovolemic hemodilution|In the ANH arm, after induction of general anesthesia, a total blood volume of at least 650 ml of blood will be drawn from a central line. The amount of volume drawn can be replaced with Ringer lactate or a similar crystalloid fluid up to a 3:1 ratio.
15866045|NCT03913481|Procedure|Standard care|Best available treatment without ANH
15866046|NCT03913468|Drug|Intravenous Ascorbic Acid|1.5 grams IV ascorbic acid q6h, 50 mg IV hydrocortisone q 6 hours, and 200mg IV thiamine BID administered (as documented in medical record)
15866047|NCT03913455|Drug|Guadecitabine|Guadecitabine 30 mg/m2 subcutaneously Days 1-5
15866048|NCT03913455|Drug|Carboplatin|Carboplatin AUC 4 IV Day 5
15866049|NCT03913442|Drug|Colchicine 0.8 mg or 0.6 mg orally once daily|Colchicine 0.8 mg orally once daily for 1.5 months, and then 0.6 mg once daily for the remainder of the time (1.5 months)
15866050|NCT03913442|Drug|Placebo oral capsule|Placebo 0.8 mg or 0.6 mg orally once daily for 3 months
15866051|NCT03913429|Procedure|Infiltration|"Infiltration performed by the surgeon at the intraoral and intranasal submucosal level in the maxilla (blockage of terminal branches of the maxillary nerve) after intubation and previous to surgical incision.
~A total of 50ml of the following preincisional mixture is infiltrated: ½ amp Adrenaline + 1amp Lidocaine 2% in physiological saline (SF) 100ml"
15866052|NCT03913429|Procedure|Maxillary nerve blockade|"Bilateral ultrasound-guided maxillary nerve block by suprazygomatic route after intubation and previous to surgical incision performed by the anesthesiologist.
~A total of 5ml of Ropivacaine 0.37% infiltrated on each side. Together with adrenaline infiltration performed by the surgeon at the intraoral and intranasal submucosal level in the maxilla.
~A total of 50ml of the following preincisional mixture is infiltrated: ½ amp Adrenaline + 110ml SF."
15866053|NCT03913416|Device|3D printed model|Before surgery, the surgeon will have a 3D printed model of the pulmonary malformation as well as the lung, the rib cage and the tracheal trunk based on the initial scanner images. He will then be able to train and plan the surgical strategy, as well as to discuss the pulmonary exclusion with the anesthetist.
15866054|NCT03913416|Other|Control group|The control group is composed of patients operated with standard surgery
15866055|NCT03913403|Procedure|ECHO|Echocardiogram at baseline and 24 hours later
15866056|NCT03913403|Procedure|Blood Draw|Blood Draw for Troponin Levels - 5ml at baseline and 24 hours later
15866057|NCT03913377|Device|Spectacles|Subjects' own habitual spectacles
15866062|NCT03913338|Procedure|LasikXtra|By randomized selection, one eye was treated with the LASIK Xtra procedure that consists of fs-LASIK treatment combined with intraoperative accelerated continuous UV-riboflavin crosslinking. After laser ablation, the corneal bed under the flap was coated with riboflavin, rinsed with saline solution, and after 90 seconds the corneal flap was repositioned. The eye was irradiated at 30 mW/cm2 for 90 seconds with continuous UVA.
15866063|NCT03913338|Procedure|LASIK|Femtosecond-assisted preparation of a corneal flap and subsequently excimer-laser ablation of corneal stroma. Repositioning of the corneal flap and installation of a therapeutic contact lens.
15866064|NCT03913325|Other|PREVSAM model|A person-centred rehabilitation plan, including coordinated measures within primary health care as well as in collaboration with participants' employers, and when relevant the Swedish Public Employment Agency
15866065|NCT03913325|Other|Treatment as usual (standard treatment)|Treatment as usual (ordinary/standard) treatment. Can include unimodal or multimodal treatment of physiotherapy solely and/or occupational therapy
15866066|NCT03913312|Biological|Unrelated cord blood|Unrelated cord blood comes from Shandong cord blood bank. TNC>1.5*107/kg;HLA 4-5/6
15866067|NCT03913286|Device|Cortimo|The Cortimo comprises an implanted brain activity sensor and a wearable powered arm orthosis.
15866068|NCT03913273|Procedure|AMI transtibial amputation|Two Agonist-antagonist myoneural interfaces (AMIs) were surgically constructed during a modified transtibial amputation procedure. Each AMI was made of natively innervated and vascularized muscle segments - an agonist and antagonist - that were surgically connected in series within the amputated residuum. Tarsal tunnels, including segments of each tunnel's native tendon component, were procured from the amputated joint. The tunnels were affixed to the residual limb tibia and the AMIs were constructed by coaptation of an agonist and an antagonist muscle to either end of the tendon passing through the tunnel. Consequently, the force produced by one muscle stretches its partner such that the AMI can communicate signals from the mechanoreceptors in both muscles to the central nervous system.
15866069|NCT03913273|Procedure|Standard transtibial amputation|A standard transtibial amputation was performed according to traditional techniques. No surgical construction of agonist-antagonist myoneural interfaces (AMIs) was performed.
15866070|NCT03913260|Drug|LY3375880|Administered SC
15866071|NCT03913260|Drug|Buffer Matrix (No LY3375880)|Administered SC
15866072|NCT03913260|Device|Autoinjector (AI)|AI used to administer LY3375880 or Buffer Matrix
15866073|NCT03913260|Device|Manual Syringe|Manual syringe used to inject LY3375880
15866074|NCT03913247|Other|Size Measurement using a measuring tape, a caliper and a metric|Each patient will have the following measure: measure of the span, the tibia, the ulna, the distance between the hill and the knee, the head, the trunk and the leg. The different measures will be done using a measuring tape and with a caliper. Before leaving the intensive care unit, each patients will be measured according to the WHO standard, that is to say strictly lengthened, using a metric for patient younger than 2 and stand up using a stadiometer for patient older than 2.
15866075|NCT03913234|Drug|Ribociclib, Trastuzumab, Letrozole|Phase IB: letrozole 2.5mg (fixed dose), trastuzumab (8mg/kg loading followed by 6mg/kg q 3weeks, fixed dose) plus ribociclib (dose escalation from 200mg to 600mg) to identify recommended phase iI dose (RPIID) Phase II: letrozole, trastuzumab (same as phase IB) plus ribocicilb RPIID
15866076|NCT03913221|Drug|Caffeine Citrate 5 mg/kg|Loading dose of caffeine 20 mg/kg IV followed by two daily doses of 5 mg/kg IV.
15866077|NCT03913221|Drug|Caffeine Citrate 10 mg/kg|Loading dose of caffeine 20 mg/kg IV followed by two daily doses of 10 mg/kg IV.
15866078|NCT03913208|Procedure|Priority to freeze|Priority for cryopreservation and later on embryo transfer in artificial cycle with endometrium preparation by the exogenous administration of estrogen-progesterone.
15866079|NCT03913208|Procedure|Fresh embryo transfer|usual strategy of giving the priority for fresh embryo transfer
15866080|NCT03913195|Drug|ibalizumab-uiyk|Ibalizumab-uiyk is an IgG4 monoclonal antibody targeting domain 2 of the extracellular portion of the CD4 protein. Ibalizumab-uiyk is FDA approved for the treatment of multi-drug resistant HIV in treatment experienced patients.
15866081|NCT03913182|Drug|apatinib|500mg po Qd
15866082|NCT03913169|Other|Educational Implementation of Interprofessional Curriculum|The intervention utilized in this project will involve a 2-year curriculum. The year one/pre-clinical curriculum will be presented to pre-clinical doctor of osteopathic medical students (DO) and physician assistant students (PA) students. The year two/clinical curriculum will be presented to third year DO students and second year PA students once clinic sites are identified.
15866083|NCT03913156|Other|B2970 Metabolic Texture Modified Protein Substitute|The study product is a powdered phe-free protein substitute supplemented with long chain polyunsaturated fatty acids (LCP's), containing essential and non-essential amino acids, carbohydrate, fat, vitamins, minerals and trace elements and has been designed for use in the management of proven PKU in children aged 6 months to 5 years.
15866084|NCT03913143|Drug|sepofarsen|RNA antisense oligonucleotide for intravitreal injection
15866085|NCT03913143|Other|Sham|Sham intravitreal injection (no experimental drug administered)
15866086|NCT03913130|Drug|QR-110|First treated eye: maintenance dose every 6 months, intravitreal administration Contralateral eye: loading dose followed by maintenance dose, every 6 months, intravitreal administration
15866087|NCT03913117|Biological|pNGVL4aCRTE6E7L2|Naked pNGVL4aCRTE6E7L2 DNA plasmid
15866088|NCT03913117|Biological|TA-CIN|TA-CIN is a single fusion protein comprised of HPV16 L2, E7 and E6 proteins linked in tandem.
15866089|NCT03913104|Drug|Mifepristone|Patients will have MifeprexⓇ (mifepristone) shipped to a preferred address via an online mail order pharmacy rather than standard care at clinic visit.
15866090|NCT03913091|Drug|Liposomal Bupivacaine|Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL
15866091|NCT03913091|Drug|0.5% Bupivacaine HCL|0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)
15866092|NCT03913078|Behavioral|Group Fitness|Traditional Group Fitness consisting of aerobic and strength exercises performed in a group setting and led by a trained instructor.
15866093|NCT03913078|Behavioral|PlayFit|Modified sports fitness exercise program consisting of games played in groups and led by a trained instructor.
15866094|NCT03913065|Diagnostic Test|CT|"Head computed tomography on patients still unconscious 48 hours after cardiac arrest.Visual evaluation of generalized oedema (eye-balling). Manual and automated measurement of the differentiation of gray and white matter (GWR) using circular regions of interest (ROI)."
15866095|NCT03913052|Procedure|Intra-articular Viscosupplement Application|Injection containing hyaluronic acid, chondroitin sulphate and glucosamine is performed once when the knee joint was in the supine position and the knee is in the extension.
15866096|NCT03913039|Procedure|Transperineal biopsy Protocol|"Transperineal biopsy approach with avoidance of rectal flora
~MRI-ultrasound fusion-guided biopsies with reduced number of biopsy cores, where clinically indicated
~Rectal swab to identify the presence of fluoroquinolone resistant (FQR) bacteria
~Multi-antibiotic prophylaxis
~Urine culture, prostate tissue culture and rectal swab culture to define contemporary, region-specific antibiotic resistance patterns."
15866097|NCT03913026|Biological|Transplant with an expanded ECT-001 cord blood|"Patients will receive a conditioning regimen (such as: cyclophosphamide 120 mg/kg, fludarabine 75mg/m2 and TBI 12 Gy or cyclophosphamide 50 mg/kg, fludarabine 150 mg/m2, thiotepa 10 mg/kg and TBI 4 Gy).
~The cord to be expanded will undergo CD34+ selection. The CD34- product is cryopreserved and will be thawed and infused on Day +1 post-transplant. The CD34+ product will be placed in a closed culture with UM171 for a 7-day expansion and is infused on Day 0.
~Patients will receive standard supportive care and GVHD prophylaxis (such as MMF and tacrolimus). Tacrolimus will be discontinued on Day 100 post-transplant unless GVHD arises."
15866098|NCT03913013|Behavioral|Family-Focused Treatment with MCC App|12 sessions of family-focused therapy plus use of a mobile app that enhances the skill training taught in the sessions.
15866099|NCT03913000|Drug|ID-085|Hard capsules for oral administration formulated at a strength of 200 mg
15866100|NCT03912974|Drug|Escitalopram|see 'arm description'
15866101|NCT03912974|Drug|Placebo oral capsule|see 'arm description'
15866102|NCT03912961|Other|Picture of the retina with a handheld retinal camera|Patient with diabetes will have their undilated and dilated images taken, with the images being centered on the macula and on the optic disc.
15866103|NCT03912935|Other|comparison between two different intubating position|Comparing to different position (sniffing and BUHE) in endotracheal intubation for rapid sequence induction in simulated emergency cases
15866104|NCT03912922|Other|Activity regime|Activity regime of 4 days followed by a test day.
15866105|NCT03912909|Drug|Empagliflozin Oral Tablet [Jardiance]|Participants will be randomly assigned to receive either Empagliflozin 10mg/daily or Placebo and will later receive the alternate treatment. As the study is double blind neither the participant nor the study personnel will be aware of which treatment is currently being tested to avoid any effect this may have on the results. The two 4-week treatment phases will be separated by a 4-week wash out (drug-free) period. The study will consist of a total of 5 visits conducted over approximately 18 weeks; one screening visit, one baseline visit, 1 short visit at the start of the second treatment phase and 2 comprehensive testing visits, each at the end of the two treatment phases
15866106|NCT03912909|Drug|Placebo Oral Tablet|Participants will be randomly assigned to receive either Empagliflozin 10mg/daily or Placebo and will later receive the alternate treatment. As the study is double blind neither the participant nor the study personnel will be aware of which treatment is currently being tested to avoid any effect this may have on the results. The two 4-week treatment phases will be separated by a 4-week wash out (drug-free) period. The study will consist of a total of 5 visits conducted over approximately 18 weeks; one screening visit, one baseline visit, 1 short visit at the start of the second treatment phase and 2 comprehensive testing visits, each at the end of the two treatment phases
15866107|NCT03912896|Behavioral|Taekwondo|Children will participate in a 7-week taekwondo program.
15866108|NCT03912870|Other|Value of Flow Cytometry in Infectious Point of Care|"To validate the diagnostic orientation properties of two new biomarkers (CD64, CD169) for patients with infectious syndromes arriving in emergency departments. This prospective observational study will focus on the quantification of these biomarkers on a hematology tube background (Pr Morange laboratory) without modifying the usual diagnostic and therapeutic procedures. The results of these assays will be compared with the diagnoses made at the end of treatment in order to determine their sensitivity and specificity.
~This study is the preliminary study, necessary to determine the detection characteristics of these biomarkers."
15866109|NCT03912857|Drug|Camrelizumab|"Experimental: test group Drug:Camrelizumab(SHR-1210) 200mg, once every 2 weeks, each 4 weeks is 1cycle.
~Apatinib :250 mg or 375 mg, qd"
15866110|NCT03912844|Procedure|SIRT followed by liver resection or liver transplantation|The ESSURE registry is a prospective observational study. Patients are only asked to be enrolled when they are treated with SIR-Spheres microspheres followed by liver resection/liver transplantation or when SIRT has been performed with the intention to downsize/ downstage the tumor, to induce hypertrophy of the contralateral lobe, making the patient eligible for a future liver resection/transplantation. In no way will participation in the registry influence the way in which the patient is treated according to the treating clinician, or will it influence the quality of the treatment. If a patient is included in the registry, a documented decision of a multidisciplinary tumour board for the treatment algorithm including SIRT must be available. The follow-up periods depend on the treating clinician and local practice and guidelines. Typically, the follow ups are done every three months. So data of a single patient will be included over two years after the treatment.
15866111|NCT03912831|Drug|KITE-439|A single infusion of E7 T-cell receptor (TCR) T cells (KITE-439)
15866112|NCT03912831|Drug|Cyclophosphamide|Administered intravenously
15866113|NCT03912831|Drug|Fludarabine|Administered intravenously
15866114|NCT03912818|Drug|Carboplatin|Given IV
15866115|NCT03912818|Drug|Cisplatin|Given IV
15866116|NCT03912818|Procedure|Cystectomy|Undergo cystectomy
15866117|NCT03912818|Drug|Doxorubicin|Given IV
15866118|NCT03912818|Biological|Durvalumab|Given IV
15866119|NCT03912818|Drug|Gemcitabine|Given IV
15866120|NCT03912818|Drug|Methotrexate|Given IV
15866121|NCT03912818|Drug|Vinblastine|Given IV
15866122|NCT03912805|Biological|botulinum toxin, Type A|topical liniment
15866123|NCT03912805|Biological|Vehicle|Vehicle Formulation
15866124|NCT03912779|Behavioral|C2Hear RLOs|Freely available online RLOs
15866125|NCT03912779|Behavioral|Printed hearing aid booklet|Departmental printed hearing aid booklet (standard care)
15866126|NCT03912766|Diagnostic Test|serum copeptin|routine surgical method using resectoscope inserted into the urinary bladder
15866195|NCT03912285|Drug|Amlodipine10mg|Amlodipine 10mg will be administered orally twice a day for 9 days
15866196|NCT03912285|Drug|Losartan potassium 100mg|Losartan 100mg will be administered orally once a day for 9 days
15866127|NCT03912753|Behavioral|Comunică|Comunică is based on the Information-Motivation-Behavioral Skills (IMB) model of health behavior change, which postulates that individuals must possess the requisite information for enacting sexual health, motivation to change their HIV risk and alcohol use, and behavioral skills necessary for reducing their risk. Therefore, Comunică includes MI to provide accurate information about HIV transmission, alcohol abuse, and local GBM-affirmative health resources and build motivation to improve behavioral skills (via CBST). CBST is a therapeutic approach used in the treatment of various behavioral problems, such as alcohol abuse and depression and more recently HIV risk. CBST can help modify cognitions driving unhealthy behaviors, promote awareness of contextual triggers and unhealthy behavioral patterns, and teach coping skills to improve health. Comunică also draws upon minority stress theory recognizing that stigmatizing societal contexts compromise health behavior.
15866128|NCT03912753|Other|Education Attention Control|The EAC condition consists of eight self-administered modularized topics, content-matched with the Comunică sessions, which we have generated based on our HIV-prevention education with GBM in the US and Romania.
15866129|NCT03912740|Drug|Dexmedetomidine|Patients in the dexmedetomidine-remifentanil group will receive an infusion of 0.6 mcg/kg in half an hour followed by an infusion of 0.6 mcg/kg/hour.
15866130|NCT03912740|Drug|sodium chloride|Patients in the remifentanil group will receive an infusion of 0.9% sodium chloride instead of dexmedetomidine (identical infusion rate)
15866131|NCT03912740|Drug|Remifentanil|Both groups will have remifentanil analgesia guided by the Nol-Index
15866132|NCT03912727|Dietary Supplement|Alpha-Lipoic acid plus renal replacement therapy|Alpha lipoic acid (ALA) is a vitamin-like antioxidant
15866133|NCT03912727|Other|renal replacement therapy|standard renal replacement therapy
15866134|NCT03912714|Procedure|Laparoscopic appendectomy|Surgery will be performed under general anaesthesia. The laparoscopic appendectomy can be performed with the use of 3 trocars; one subumbilical, one suprapubic and one in the lower right quadrant of the abdomen. The appendix is removed using a laparoscopic endostapler enabling a safe and complete appendectomy with the cross stapling line at coecal base. Laparoscopic appendectomy will be performed by a gastrointestinal surgeon with sufficient experience in laparoscopic appendectomies (>20).
15866135|NCT03912714|Procedure|Endoscopic appendix biopsies|Appendix biopsies will only be taken when the scope easily slides into the lumen of the appendix (the scope will not be pushed into the appendix lumen)
15866136|NCT03912701|Diagnostic Test|Vitalpac early warning score (VIEWS)|The Vitalpac early warning score (ViEWS) is an early warning system aimed primarily at prediction of the first 24-hour mortality in emergency patients and has not been used to assess intensive care unit discharge.
15866137|NCT03912688|Device|acupoint stimulation|
15866138|NCT03912688|Device|single acupoint|
15866139|NCT03912688|Device|dual acupoints|
15866140|NCT03912675|Procedure|Integra® dermal substitute and RigeneraTM protocol|Integra® dermal substitute enriched with the autologous dermal micro-grafts obtained with RigeneraTM protocol
15866141|NCT03912662|Device|Mesh augmented reinforcement|Abdominal wall sutureline reinforcement with ProgripTM Self-Gripping Polyester Mesh
15866142|NCT03912649|Device|RemovAid|The RemovAid device is used for removal
15866143|NCT03912636|Behavioral|Diaphragmatic breathing|Subjects will perform Diaphragmatic breathing after the test meal.
15866144|NCT03912636|Behavioral|Deep Slow Breathing|Subjects will perform Deep Slow Breathing after the test meal.
15866145|NCT03912636|Behavioral|Normal breathing|Subjects will perform Normal Breathing (as a control) after the test meal as a control.
15866146|NCT03912623|Other|SPA Treatment with therapeutic education and physical activity|3 weeks SPA Treatment plus therapeutic education plus physical activity
15866147|NCT03912623|Other|Week end|access to the station for a week end after maintenance of usual treatment during 6 months
15866148|NCT03912610|Diagnostic Test|Functional magnetic resonance examination|Functional magnetic resonance examination by a Ultra high field magnetic resonance instrument named MAGNATOM 7T.
15866149|NCT03912597|Device|Virtual Reality|The 4-minute virtual reality video depicts a day in a life of a student with depression. The one-take video, filmed with a 360° camera, is designed to provide users with an immersive experience that simulates what it feels like to have depression. The user interface consisted of a Google Cardboard VR headset attached to a smartphone.
15866150|NCT03912597|Device|Brochure|Participants read an informational brochure about depression depicting standard information about depression, including symptoms and information on how to support someone with depression.
15866151|NCT03912597|Device|Standard Video Control|The 4-minute standard video depicts a similar storyline as was shown in the VR video. The standard video is filmed from a third-party perspective with multiple takes edited into a final video, following the standard filming style of these videos. The standard video will be viewed from a laptop with headphones attached.
15866152|NCT03912584|Device|P200TE|The P200TE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.
15866153|NCT03912584|Device|P200TxE|The P200TxE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.
15866154|NCT03912571|Diagnostic Test|Structural 3T MRI|measures of global and hippocampal atrophy)
15866155|NCT03912571|Diagnostic Test|MRI Based Perfusion Imaging|brain blood flow
15866156|NCT03912571|Diagnostic Test|VR-CO2 MRI Scans|reduced vaso reactivity to carbon dioxide
15866157|NCT03912558|Procedure|Butterfly device implantation|The Butterfly device will be positioned and deployed with cystoscopy guidance
15866158|NCT03912545|Diagnostic Test|Quantra System|Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
15866159|NCT03912532|Biological|NGM282|NGM282
15866160|NCT03912532|Other|Placebo|Placebo for NGM282
15866161|NCT03912519|Procedure|Parallel placement of 16 gauge electrodes|Parallel technique
15866162|NCT03912519|Procedure|Perpendicular placement with 22 gauge electrodes|Perpendicular technique
15866197|NCT03912285|Drug|Amlodipine plus Losartan|"Amlodipine plus Losartan same way as arm: amlodipine and arm: losartan"
15866198|NCT03912272|Behavioral|High-intensity Interval Training|In the high-intensity interval training group, subjects will receive respective prescribed exercise once a week.
15882021|NCT03789214|Drug|High Dose Suvorexant|High Dose Suvorexant
15866163|NCT03912493|Device|Game Based Virtual Reality Exercises|A game-based virtual reality device named USE-IT will be added to the rehabilitation program. USE-IT is a technological rehabilitation system designed by the Department of Physiotherapy and Rehabilitation at Hacettepe University. It is a smart gaming device which has been used in patients who suffer from movement loss in their upper extremities due to various neurological and orthopedic reasons.
15866164|NCT03912493|Other|Conventional Physiotherapy and Rehabilitation|The conventional physiotherapy and rehabilitation program includes the application of Transcutaneous Electrical Nerve Stimulation (TENS), cold pack, therapeutic ultrasound, Codman Exercises, Wand exercises, shoulder wheel exercises, finger ladder exercises, strengthening exercises with elastic band and capsule stretching.
15866165|NCT03912480|Biological|Stem cells from human exfoliated teeth|Intravenous infusion of pulp mesenchymal stem cells
15866166|NCT03912467|Other|Pressure Ulcer Evaluation|Patient was evaluated according to presence of pressur ulcer or not
15866167|NCT03912454|Other|Autologous Bone Marrow Aspirate Concentrate (BMAC) Injection|Subjects will undergo bone marrow aspiration from the iliac crest. Bone marrow will be concentrated and injected into the symptomatic lumbar disc.
15866168|NCT03912441|Biological|BCD-147|Bispecific anti-HER2 monoclonal antibody
15866169|NCT03912428|Drug|Celecoxib|COX-2 inhibitor
15866170|NCT03912428|Diagnostic Test|11C-MC1|PET radioligand for COX-2
15866171|NCT03912428|Diagnostic Test|11C-ER176|PET radioligand for TSPO
15866172|NCT03912415|Biological|BCD-100|Anti-PD-1 monoclonal antibody, IV infusion
15866173|NCT03912415|Biological|Bevacizumab|IV infusion
15866174|NCT03912415|Drug|Paclitaxel|IV infusion
15866175|NCT03912415|Drug|Cisplatin (or Carboplatin)|IV infusion
15866176|NCT03912415|Other|Placebo|Placebo
15866177|NCT03912402|Biological|BCD-100|Anti-PD-1 monoclonal antibody, IV infusion
15866178|NCT03912402|Biological|Bevacizumab|IV infusion
15866179|NCT03912402|Drug|Paclitaxel|IV infusion
15866180|NCT03912402|Drug|Cisplatin (or carboplatin)|IV infusion
15866181|NCT03912389|Biological|BCD-100|Anti-PD-1 monoclonal antibody, IV infusion
15866182|NCT03912389|Drug|Pemetrexed|IV infusion
15866183|NCT03912389|Drug|Cisplatin (or carboplatin)|IV infusion
15866184|NCT03912389|Other|Placebo|IV infusion
15866185|NCT03912376|Diagnostic Test|Quest Hyperspectral Imaging System|In this camera 3 sensors are combined for optimal spectral imaging. For 2D reference, and to facilitate annotating the data, a high resolution (full HD) color image, recorded with an RGB-sensor, is included with each hyperspectral dataset.
15866186|NCT03912363|Other|Rotating fluids protocol|"IV fluids at a rate of 100-150 ml/hr will be administered:
~For blood glucose < 100 mg/dL or less: IV fluids with 5% dextrose
~For blood glucose between 101-140 mg/dL: IV fluids without 5% dextrose
~For blood glucose > 140 mg/dL on two consecutive occasions: insulin infusion protocol (Study arm 2)"
15866187|NCT03912363|Other|Insulin infusion protocol|"Regular insulin at 1 unit/ml AND IV fluids at a rate of 100-150 ml/hr will be administered:
~For blood glucose < 80 mg/dL: No insulin AND IV fluids with 5% dextrose
~For blood glucose 80-100 mg/dL: Insulin at 0.5 U/hr AND IV fluids with 5% dextrose
~For blood glucose 101-140 mg/dL: Insulin at 1.0 U/hr AND IV fluids with 5% dextrose
~For blood glucose 141-180 mg/dL: Insulin at 1.5 U/hr AND IV fluids with 5% dextrose
~For blood glucose 181-220 mg/dL: Insulin at 2.0 U/hr AND IV fluid without dextrose
~For blood glucose > 220 mg/dL: Insulin at 2.5 U/hr AND IV fluids without dextrose"
15866189|NCT03912337|Drug|Placebo|Placebo once every 4 weeks. SC injection.
15866190|NCT03912337|Drug|Erenumab|Erenumab once every 4 weeks. SC injection.
15866191|NCT03912324|Procedure|Unipolar voltage subtraction map guided PV isolation group|"Pulmonary vein isolation will be performed using a radiofrequency catheter
~Esophageal temperature will be monitored to prevent esophageal injury
~Mapping of echocardiographic unipolar voltage subtraction after atrial septal puncture
~the electrode map data is transferred to the core lab by network to calculate the unipolar voltage subtraction color map (within 10 minutes)
~Increase radiofrequency ablation time by 2 to 5 seconds in areas with high potential in unipolar voltage subtraction color map
~Decrease radiofrequency ablation time by 2 to 5 seconds in areas with low potential in unipolar voltage subtraction color map
~Evaluation of success rate and time of pulmonary vein isolation after bilateral pulmonary vein primary columnar resection
~Evaluate time to complete isolation after additional ablation
~Evaluation of Procedure and Ablation time, and perfusion saline dose
~Rhythm follow-up after the procedure in accordance with the study design."
15866192|NCT03912324|Procedure|CT myocardial thickness map guided PV isolation group|"Pulmonary vein isolation will be performed using a radiofrequency catheter
~Esophageal temperature will be monitored to prevent esophageal injury.
~Prepared myocardial thickness map with CT DICOM images conducted prior to procedure.
~Increase radiofrequency ablation time by 2 to 5 seconds in thick areas in CT myocardial thickness map
~Decrease radiofrequency ablation time by 2 to 5 seconds in thin areas in CT myocardial thickness map
~Evaluation of success rate and time of pulmonary vein isolation after bilateral pulmonary vein primary columnar resection
~Evaluate time to complete isolation after additional ablation
~Evaluation of Procedure time, Ablation time, and perfusion saline dose
~Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design."
15866193|NCT03912324|Procedure|Empirical PV isolation group|"Pulmonary vein isolation will be performed using a radiofrequency catheter
~Esophageal temperature will be monitored to prevent esophageal injury.
~The procedure is performed by adjusting radiofrequency energy according to the traditional method and experience of the practitioner.
~Evaluation of success rate and time of pulmonary vein isolation after bilateral pulmonary vein primary columnar resection
~Evaluate time to complete isolation after additional ablation
~Evaluation of Procedure time, Ablation time, and perfusion saline dose
~Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design."
15866194|NCT03912298|Other|Opioid Taper Pain perception|Pain Responses: The primary dependent variable, pain, will be measured using two highly reliable and valid pain induction techniques, the CPT and QST, employing procedures consistent with those described in the literature. Order of pain testing will vary, and three aspects of the pain response will be captured at each study session: evoked pain; temporal summation; and conditioned pain modulation, which map on to the hypothesized peripheral, spinal and supra-spinal mechanisms of OIH. Protocols for each assay have been uploaded.
15866199|NCT03912272|Behavioral|Usual Care Control|In the usual care control group, obesity-related health briefing, dietary caloric restriction advice, and lifestyle counseling/consultation will be provided.
15866200|NCT03912259|Drug|Dupilumab|"Pharmaceutical form: solution,
~Route of administration: SC"
15866201|NCT03912259|Drug|Placebo|"Pharmaceutical form: solution,
~Route of administration: SC"
15866202|NCT03912259|Drug|Emollient (moisturizer)|"Pharmaceutical form: cream,
~Route of administration: topical use"
15866203|NCT03912246|Biological|biological samples|collection of blood, urine, saliva, stool, skin and mouth swabs, tears
15866204|NCT03912246|Procedure|lumbar puncture|collection of cerebrospinal fluid
15866205|NCT03912233|Drug|VX-121|VX-121 tablet for oral administration.
15866206|NCT03912233|Drug|TEZ|TEZ tablet for oral administration.
15866207|NCT03912233|Drug|VX-561|VX-561 tablet for oral administration.
15866208|NCT03912233|Drug|TEZ/IVA|100 mg TEZ/150-mg IVA, film-coated fixed-dose combination (FDC) tablet for oral administration.
15866209|NCT03912233|Drug|IVA|150-mg film-coated tablet for oral administration.
15866210|NCT03912233|Drug|Placebo|Matched Placebo.
15866211|NCT03912220|Drug|Nicotinamide riboside|The experimental arm will investigate the effects of nicotinamide riboside on nerve degeneration and regeneration.
15866212|NCT03912220|Drug|Placebo Oral Tablet|Placebo drug that looks like the experimental drug, nicotinamide riboside tablets.
15866213|NCT03912207|Biological|BCG Danish|BCG Danish 1331 is on the WHO list of pre-qualified vaccines and has a well-defined side effect profile. BCG is licensed for delivery via the intradermal route. It is not licensed for delivery via the aerosol route.
15866214|NCT03912207|Other|Saline placebo|Saline is a routinely used placebo.
15866215|NCT03912194|Behavioral|cognitive-behavioral withdrawal regulation strategies|Participants will generate and refine individualized withdrawal regulation strategies with the aid of a therapist
15866216|NCT03912194|Behavioral|relaxation strategies|Participants will generate and refine relaxation techniques with the aid of a therapist
15866217|NCT03912194|Behavioral|early withdrawal exposure|Exposure to the first 4 hours of abstinence across 4 separate sessions
15866218|NCT03912168|Other|Question Prompt List|Question prompt list for common orthopaedic conditions
15866219|NCT03912168|Other|3 questions list|3 questions from the AskShareKnow model
15866220|NCT03912155|Other|Multi-scale analysis of physiological brain networks|It will be simultaneously record the surface EEG, the MEG and in patients only the intracerebral EEG (SEEG). In the case of SEEG with micro contacts, these additional signals will also be recorded in parallel and will provide greater sensitivity to high frequency activities. The physiological networks will be studied in patients thanks to stimulations (external or intracerebral) carried out within the framework of the functional cartography, and the pathological networks thanks to measures in state of rest. For external stimulation protocols, it will be constitute a reference base in MEG and EEG alone (non-invasive) on control subjects.
15866221|NCT03912142|Diagnostic Test|three dimensional Transperineal Ultrasound Scan|Diagnostic test: three dimensional transperineal ultrasound scan
15866222|NCT03912129|Genetic|blood sample|"A first systematic approach by Targeted-Next Generation Sequencing will be used on the entire cohort of patients with pSE. This step will be performed on a sequencing chip specifically developed to detect anomalies in known genes involved in autoimmunity.
~In patients for whom no mutations are identified, a whole exome sequencing (WES) approach will be applied to patients and their parents to seek to identify mutations in new genes that may be related to pSE.
~In patients for whom this WES approach is unsuccessful, the search for somatic lymphocyte mutations, or copy number variants will be performed before considering a complete genome sequencing .
~If several candidate genes are identified, the clinical data provided by the CEREVANCE and the phenotypic analyses carried out prior to genetic analyses by the CEDI laboratory will guide the choices to prioritize the study of the identified variants."
15866223|NCT03912116|Other|CLARIX FLO|100mg CLARIX FLO
15866224|NCT03912116|Other|Saline|Saline
15866225|NCT03912103|Other|Interdisciplinary Deprescribing and Medication Optimization Intervention|as current
15866226|NCT03912077|Behavioral|Culturally Adapted Cognitive Behavioural Therapy|7-session psychosocial intervention
15866227|NCT03912064|Drug|Ipilimumab|Ipilimumab is an antibody that acts against CTLA-4
15866228|NCT03912064|Biological|CD25hi Treg depleted DLI|Donor lymphocyte product
15866229|NCT03912051|Device|asymmetric balloon|Asymmetric balloon for treatment of intranasal bleeding
15866230|NCT03912038|Other|No intervention.|No intervention
15866231|NCT03912025|Other|Relationship between positive mindset and exercise capacity|No intervention. Cross-sectional study looking at the relationships between questionnaire scores and outcomes
15866232|NCT03912012|Drug|Iohexol renal clearance measurement|intravenous injection of Iohexol (Omnipaque 300mg) with blood sampling at 0, 120, 180 and 240 minutes (during Day 1.
15866233|NCT03912012|Device|microcirculation assessment through Laser Doppler associated to iontophoresis.|endothelial function evaluated following a protocol of iontophoresis of acetylcholine (during Day 1).
15866234|NCT03912012|Device|Cardiovascular assessment though Intima-media Thickness and Extra-media Thickness measurement|carotid ultrasound (during Day 1)
15866235|NCT03912012|Biological|Blood sampling|37 mL of blood sample will be performed at Day 1
15866236|NCT03912012|Biological|Urine sampling|The urinary collection will be done during the Day 1, on the first morning urination
15866237|NCT03912012|Device|High-resolution peripheral quantitative computed tomography (HR-pQCT)|assessment of the Body Mass Index by HR-pQCT (during the Day 1)
15866238|NCT03912012|Radiation|Dual-energy X-ray (DXA)|assessment of bone parameters by DXA (during the Day 1)
15866239|NCT03911986|Device|R Test 4 External Loop Recorder|The R-Test 4 is an externally worn, re-usable, battery-powered, lightweight ECG monitor, which records events triggered by cardiac arrhythmias. It is worn for 7 days. Cardiac monitoring is triggered by tachycardia or detection of irregular pulses or patient may trigger recording, if the participant experience symptoms (e.g. palpitations). The patient wears 2 chest leads (on one, the R-Test device is attached, weight 42g). The R-Test 4 is CE marked, and uses an FDA-approved algorithm for automatic detection of atrial fibrillation, and permits 5 minutes of pre-event recording and 5 minutes of post-event recording.
15866240|NCT03911973|Drug|Gedatolisib|Gedatolisib, 150-180MG IV
15866242|NCT03911960|Behavioral|Acceptance and Commitment Therapy|2 in person and 5 telephone sessions of acceptance and commitment therapy for tobacco cessation plus up to 8 weeks of nicotine patch
15866243|NCT03911960|Behavioral|Enhanced Usual Care|2 in person sessions of tobacco cessation counseling, up to 8 weeks of nicotine patch, referral to state quitline.
15866244|NCT03911947|Device|Vibrolung|Device for vibroacoustic respiratory therapy
15866245|NCT03911934|Other|Polypharmacy intervention|A physician from the Department of Clinical Pharmacology prepares a critial medication review before the first visit in the outpatient clinic through critical review of the patient's medical journal and communication with the patient's GP. During the visit in the outpatient clinic, medications are changed based on the medication review with consent from the patient. After the visit the GP is notified of the changes. It is possible to see the patient more than one time in the outpatient clinic (might be needed if tapering or lots of changes) and possible to follow-up on medication changes by telephone with the patient.
15866246|NCT03911934|Other|Usual care|Usual care in the geriatric outpatient clinic with geriatric assessment from a trained geriatrician
15866247|NCT03911921|Drug|RSYRT decoction|Compound granules of traditional Chinese medicine
15866248|NCT03911921|Drug|Astragalus membranaceus|One herb
15866249|NCT03911908|Combination Product|Cerebral oximetry (near infrared) based CPR-Algorithm|If NIRS values do not increase over time until ROSC (target: >40 % after 10 min), interventions are suggested in a modified CPR/NIRS algorithm.
15866250|NCT03911895|Device|Stent more than 26 mn length|stent length in patients undergoing PCI (Drug Eluting Stent)
15866251|NCT03911895|Device|Stent equal to or less than26 mn length|stent length in patients undergoing PCI (Drug Eluting Stent)
15866252|NCT03911882|Dietary Supplement|Celergen Administration|The food supplement Celergen was administered on a daily basis for a total of 3 months (90 days) to participating fibromyalgia patients
15866253|NCT03911869|Drug|encorafenib|taken orally
15866254|NCT03911869|Drug|binimetinib|taken orally
15866255|NCT03911856|Other|Echocardiography|We hypothesize that non-invasive indices of RV (echocardiograph-derived strain and strain rate) and pulmonary (gas exchange-derived lung diffusion and surface area) function during light exercise will successfully identify and discern patients with known RV dysfunction (PAH/HFpEF with RV failure) from those with known pulmonary dysfunction (PAH/HFpEF with pulmonary fibrosis). Additionally, we hypothesize that our assessment techniques will identify subtle derangements in RV and pulmonary function in newly diagnosed PAH and HFpEF patients, and that this may guide early and targeted therapeutic intervention.
15866256|NCT03911856|Other|Pulmonary Gas Exchange|We hypothesize that breathing hyperoxia will increase exercise capacity by reversing RV and pulmonary derangements, and that the mechanisms of action will be related to the underlying dysfunction (e.g., reducing PVR, increasing RV functional reserve, increasing gas diffusion).
15866257|NCT03911843|Drug|omega-3 supplementation|Supplementation with Ω-3, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) at a dose of 50-60 mg/kg/day for 12 months, currently underway or completed after 12 months of omega-3 administration, in 22/64 T1D children
15866258|NCT03911843|Drug|Vitamin D supplementation|Cholecalciferol 1000 IU/die
15866259|NCT03911830|Other|Exercise followed cold water immersion|Rehabilitation program of 17 sessions with 30 minutes of exercise followed by 15 minutes of submerged recovery at 17 ° C (3 sessions per week / 6 weeks).
15866260|NCT03911817|Drug|Midodrine|The oral vasoactive drug (Midodrine) at a dose of 10-20 mg every 8 hours will be used in one arm .After the blood pressure goal is met for more than 24 hours without IV vasopressor ,midodrine will be discontinued prior to discharge
15866261|NCT03911804|Procedure|bolus group and infusion group for epidural block|Randomly selected patients of the bolus group are given 0.3 ml/kg bolus/hr of 0.15% ropivacaine for epidural analgesia. In contrast, patients in the infusion group are administered 0.3 ml/kg/hr 0.15% ropivacaine at a constant rate for epidural analgesia.
15866262|NCT03911778|Other|Improvement of symptoms|Improvement of symptoms on the Patient Global Impression of Improvement Index (PGI-I) scale (score 1, 2, or 3) at 6 weeks postoperatively
15866263|NCT03911765|Behavioral|digital cognitive training|Digital cognitive exercises, used in the intervention group, have the primary objective of stimulating executive functions, and will be made available through the Internet using the BrainHQ platform.
15866264|NCT03911752|Other|Semi-structured interviews|Semi-structured interviews were used to obtain the main data in this study.
15866265|NCT03911752|Other|Canadian Occupational Performance Measure|The Canadian Occupational Performance Measure was used with the group of people with Acquired Brain Injury to know their occupational priorities.
15866266|NCT03911739|Drug|Buprenorphine Injection|Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
15866267|NCT03911739|Drug|Buprenorphine Sublingual Product|Sublingual buprenorphine (BUP-SL), administered daily.
15866268|NCT03911726|Radiation|Single PET/MR-measurement|A single PET/MR-measurement using [18F]Fallypride with a duration of 180min. Within this measurement, the dopamine receptor agonist apomorphine is applicated.
15866269|NCT03911713|Drug|VX-561|VX-561 tablets for oral administration.
15866270|NCT03911713|Drug|IVA|150-mg film-coated tablet for oral administration.
15866271|NCT03911713|Drug|Placebo|Placebo matched to IVA.
15866272|NCT03911713|Drug|Placebo|Placebos matched to VX-561.
15866273|NCT03911687|Behavioral|CONCERN CDS system notification|"The CONCERN CDS will trigger based on analytics of nursing documentation that indicates recognition and concern of patient changes. The CONCERN CDS will alert the care team of the patients risky state to increase team-based situational awareness (i.e., shared understanding of the patient situation) of patients predicted to be at risk for patient decompensating in need of rapid intervention to prevent mortality and associated harm.
~Version 1: Burn in phase to evaluate adoption and adaptation to the algorithm being studied. Expected time frame - 3 months
~Version 2: Version 2 refined based on continuous monitoring of data. Expected time frame - 3 months
~Version 3: Version 3 refined based on continuous monitoring of data. Expected time frame - 3 months"
15866274|NCT03911674|Other|Oral manual stimulation of feeding in preterm infants|Manual stimulation of the cheeks (internal and external), lips, gums, tongue and palate by finger-strokin.
15866275|NCT03911661|Other|Fearon warfarin dosing algorithm|Blood test drawn by patient using a point of care INR monitor
15866276|NCT03911661|Other|Usual care|Historical management of warfarin by patient's usual care providers
15866281|NCT03911609|Other|Exercise|Subjects will perform isometric (static) handgrip exercise at submaximal intensity for four minutes. The exercise will be performed while the subject is seated, and the elbow bent at around 90° and unsupported. Subjects will be asked to rate their pain using numerical pain rating scale that ranges from 0 (no pain) to 10 (worst pain), perceived exertion (RPE) from 0 (Nothing at all) to 10 (extremely strong), and perceived stress from 0 (not stressed at all) to 10 (extremely stressed). The ratings of pain intensity, RPE and perceived stress will be provided before, at the middle and at the end of the exercise.
15866282|NCT03911609|Other|Cognitive Task|The mental math task, which is also known as serial subtraction test, will be performed for four minutes. Subjects will be asked to rate their pain intensity and perceived stress before, at the middle and at the end of the mental math task.
15866283|NCT03911596|Device|Smart Autofocusing Eyeglasses|The smart eyeglasses system is meant to be a next generation alternative technology which replaces the generic eyeglasses used for correction of refractory defects in human vision. These smart eyeglasses do not fix any internal eye problems. They just externally compensate for the loss of eye focusing functions caused by presbyopia. This system is a medical assistive device which is meant to improve the quality of life of presbyopic patients.
15866284|NCT03911583|Behavioral|Control Group (CG)|The control group does not receive these notifications (PUSH)
15866285|NCT03911583|Behavioral|Moderate physical activity group (MPA)|The women of the experimental group receive PUSH notifications remembering the objective set in consultation and encouraging them to achieve it.
15866286|NCT03911583|Behavioral|Intense physical activity group (IPA)|The women of the experimental group receive PUSH notifications remembering the objective set in consultation and encouraging them to achieve it.
15866287|NCT03911570|Drug|Glucosamine Sulfate|Therapy with the prescription formulation of crystalline glucosamine sulfate
15866288|NCT03911557|Drug|Durvalumab and Tremelimumab|Durvalumab 1500mg + tremelimumab 75mg via IV infusion Q4W, starting on Week 1, for up to a maximum of 4 doses/cycles followed by durvalumab monotherapy 1500 mg via IV infusion Q4W, starting 4 weeks after the last infusion of the combination, for up to a maximum of 2 years of total therapy.
15866289|NCT03911544|Device|BIS monitor|Participants allocated to the intervention group will receive TIVA anesthesia adjusted by the BIS monitoring in addition to clinical signs of poor anesthesia.
15866290|NCT03911531|Diagnostic Test|Whole Exome Sequencing|Whole exome sequencing (WES) provides more detailed information through greater resolution, identifying single base-pair changes and small insertions and deletions. WES performs sequencing on the protein-coding exons, which are contained in 1-2% of the genome but make up over 85% of all known pathogenic mutations.
15866291|NCT03911531|Diagnostic Test|Whole Genome Sequencing|Whole Genome Sequencing (WGS) has emerged in recent years as a diagnostic tool that sequences the entire genome and can pick up insertions or deletion of bases, structural variants and intronic single nucleotide variations.
15866292|NCT03911518|Procedure|Loop drainage|Loop drainage will occur via 2 small incisions, approximately 2 cm, with the cuff from the base of a sterile glove pulled through and then tied off.
15866293|NCT03911518|Procedure|Incision and drainage|The wound will be incised with a #11 blade scalpel along the point of maximal fluctuance, approximately 2-3 cm, and then all loculations bluntly dissected with a set of Kelly clamps. After drainage of pus, the wound will be loosely packed with gauze.
15866296|NCT03911492|Procedure|SCPP Management => 65 mmHg|A lumbar intrathecal catheter will be inserted pre-operatively for the measurement of Intrathecal pressure (ITP) and the collection of cerebrospinal fluid (CSF) samples. SCPP will be calculated as the difference between Mean Arterial Pressure (MAP) and the ITP.
15866297|NCT03911479|Procedure|Bariatric Surgery|Bariatric Surgery - convencionals Roux-en-Y gastric bypass (RYGB) and vertical gastrectomy (Sleeve; SG)
15866298|NCT03911466|Drug|Buprenorphine Injection|Weekly and monthly formulations of injectable, extended-release buprenorphine (BUP-XR).
15866299|NCT03911466|Drug|Buprenorphine Sublingual Product|Sublingual buprenorphine (BUP-SL), administered daily.
15866300|NCT03911453|Drug|Rucaparib|Patients will be treated with single agent rucaparib for 3wks and then proceed to surgery. Core-biopsies (at the time of diagnosis) and tumor from the surgical resection will be assessed for change in expression of PD-L1 by Immunohistochemical assay (IHC).
15866301|NCT03911440|Drug|Doxycycline|Oral doxycycline is given with a dosage of 2-4 mg/kg/day divided into twice a day for 5-10 days.
15866302|NCT03911440|Drug|Azithromycin|Azithromycin is given with a dosage of 10 mg/kg/day once a day for 3 days.
15866303|NCT03911427|Other|Active oat beverage|Powder packaged in sachets, mixed with water and consumed 3 times per day for 1 month
15866304|NCT03911427|Other|Control rice beverage|Powder packaged in sachets, mixed with water and consumed 3 times per day for 1 month
15866305|NCT03911414|Drug|Open-label Treatment with Omega-3 Fatty Acids + Inositol|Open-label Treatment with Omega-3 Fatty Acids + Inositol
15866306|NCT03911414|Drug|Open-label Treatment with N-acetylcysteine|Open-label Treatment with N-acetylcysteine
15866307|NCT03911401|Drug|0.3% OPA-15406|Twice daily
15866308|NCT03911401|Drug|1% OPA-15406|Twice daily
15866309|NCT03911401|Drug|Placebos|Twice daily
15866310|NCT03911388|Biological|G207|Single dose of G207 infused through catheters into region(s) of tumor. If G207 is safe in the first cohort of patients, subsequent patients will receive a single dose of G207 infused through catheters into region(s) of tumor followed by a 5 Gy dose of radiation to the tumor (which includes progressive leptomeningeal disease or any site of gross tumor progressing in the brain parenchyma) within 24 hours of virus inoculation.
15866311|NCT03911375|Other|Mindfulness Based Stress Reduction (MBSR)|"Psycho-educational program of stress reduction based on mindfulness. Program of 30 hours of duration divided into 9 sessions with a weekly frequency of 2.5 h and an intensive session between week 6 and 7 of the program with a duration of 7.5 hours.
~Each week the theoretical contents necessary to understand the attention development practices proposed in mindfulness-based interventions will be covered. In addition, basic concepts of the psychobiology and psychology of stress and pain are explained. The subjects will have a homework load of approximately 45 minutes per day during the duration of the intervention."
15866312|NCT03911362|Behavioral|Lumbopelvic Stabilisation Exercises Group|Lumbopelvic stabilisation exercises will be taught the basic movement, starting with co-contraction of the transversus abdominis (TA) muscle and other muscles together with diaphragm breathing, and continuing the exercises with upper and lower extremity movements together with TA and multifidus contraction.
15866313|NCT03911362|Behavioral|Pelvic Floor Exercises Group|The pelvic flor exercise will be in the form of contraction-release for rapidly contracting muscle fibres, and for slowly contracting muscle fibres, slow contraction by counting to ten, hold for a count of ten, then gradually relax by counting to ten
15866314|NCT03911336|Drug|Group A - test:Tooth extraction and intake of NSAID and a non-NSAID|Tooth extraction and intake of an NSAID (i.e. Ketoprofen ER 50 mg) at 8 AM and a non-NSAID (i.e. Acetaminophen / Paracetamol 500 mg) at 2 PM and 8 PM for a 3-day period, starting the regime at 2 PM on the day of the extraction.
15866315|NCT03911336|Drug|Group B - Control 1: tooth extraction and intake of NSAID and a non-NSAID|Tooth extraction and intake of an NSAID (i.e. Ketoprofen ER 50 mg) at 8 PM and a non-NSAID (i.e. Acetaminophen / Paracetamol 500 mg) at 8 AM and 2 PM for a 3-day period, starting the regime at 2 PM on the day of the extraction.
15866316|NCT03911336|Drug|Group C - Control 2: tooth extraction and intake of a Non-Nsaid|Tooth extraction and intake of a non-NSAID (i.e. Acetaminophen / Paracetamol 500 mg) at 8AM, 2 PM and 8 PM for a 3-day period, starting the regime at 2 PM on the day of the extraction.
15866317|NCT03911323|Other|diabetic retinopathy|Patients with diabetes enrolled will undergo nonmydriatic fundus imaging and seven-field stereoscopic photography. The images will be run on an artificial intelligence (AI) algorithm. The diagnosis of the AI algorithm will be compared to the diagnosis of seven-field stereoscopic photography by ophthalmologist. Sensitivity and specificity will be calculated to evaluate the performance of AI algorithm.
15866318|NCT03911310|Diagnostic Test|[18F]PSMA-11|[18F]PSMA-11 PET/CT
15866319|NCT03911310|Diagnostic Test|[68Ga]PSMA-11|[68Ga]PSMA-11 PET/CT
15866320|NCT03911297|Other|Women with polycystic ovary syndrome|Prospective cohort study in women with polycystic ovary syndrome to identify the risk of developing metabolic disease
15866321|NCT03911271|Drug|0.1% atropine and 0.01% atropine|0.1% atropine loading dose for 6 months followed by 0.01% atropine for 18 months
15866322|NCT03911271|Drug|0.01% atropine|0.01% atropine for 24 months
15866323|NCT03911271|Drug|0.9% Sodium-chloride|Placebo for 24 months
15866324|NCT03911258|Procedure|nasopharyngeal swab versus nasal wash|The type of procedure will be determine according to patient collaboration
15866325|NCT03911245|Other|Retrospective study. Analyze of data in medical records|Retrospective study. Analyze of data in medical records
15866326|NCT03911232|Drug|sugammadex|standard general anesthesia protocol with sugammadex
15866327|NCT03911219|Other|eHealth system support for symptom management via CANKADO|Regular use of eHealth support system CANKADO by the patient: symptom self-reporting triggering alerts to the patient; in addition to standard of care symptom management.
15866328|NCT03911206|Behavioral|Inspiratory muscle training (IMT)|IMT exercises at home will gradually ramp up
15866329|NCT03911206|Behavioral|Exercise alone|Subjects will be asked to exercise 2x/week for 6 weeks in person at the Duke research facility and again 2x/week at home for 30 minutes.
15866330|NCT03911206|Behavioral|IMT and Exercise|Combining IMT training and exercise
15866331|NCT03911193|Drug|Cabozantinib|Patients will be treated with cabozantinib 60 mg/daily (cycles each 28 days) until progression, toxicity or patient refusal.
15866332|NCT03911180|Device|Proximal femoral nail with straight parallel blade|Petrochanteric fixation with Heracles proximal femoral nail
15866333|NCT03911167|Procedure|open, laparoscopic, and robotic|Radical resection of rectal cancer in robotic, laparoscopic, and open approach
15866334|NCT03911154|Device|Philips SmartSleep Technology|"During the 4 nights of sleep restriction (5 hours time in bed), subjects will have one of the following SmartSleep stimulation modalities each night in a randomized order. All subjects will receive all 4 stimulation modalities:
~Continuous Fixed Interval
~Block
~In-Phase Adjustable
~Sham: No auditory stimulation while wearing the SmartSleep headband"
15866335|NCT03911141|Behavioral|Gamification|"Participants have an 8-week ramp-up period where daily goals increase from baseline to the step target, and sign a pledge agreeing to try their best to meet their goals.
~Participants are entered into a game. Each week they receive 70 points. Each day they're told their step count and points. If the step goal was met they keep their points, but if not, they lose 10 points. At the end of the week if they have at least 40 points they move up a level, but if not, they drop a level. Participants start in the middle of 5 levels.
~Participants choose a support partner who gets a weekly email with the participant's progress. We hold a 3-way phone call with the participant and supportive sponsor to discuss ways they can help the participant meet their goal. Every 8 weeks, have a follow up call if the participant is stuck in a lower level and restart them back at the middle level.
~In the follow-up period, participants continue to get a daily text stating if they met their step goal."
15866336|NCT03911141|Behavioral|Financial|"Participants are informed that each week money is placed in a virtual account for them. Each day the participant is informed of their step count on the prior day. If the step goal was achieved, the balance remains. Each day the goal is not achieved, the participant is informed that some of the money was taken away. We will use an 8-week ramp-up period in which daily goals are increased gradually from baseline to targets.
~During the follow-up period, participants in this arm will continue to receive a daily text message stating whether or not they achieved their step goal on the prior day."
15866337|NCT03911128|Other|Observational|Observational study - no intervention
15866338|NCT03911115|Other|Food preference questionnaire|This is an online questionnaire administrated once to the participants, to assess food preferences after bariatric surgery. The investigating team will also collect data on the type of surgery, anthropometry, nutrition, taste, smell, disgust and intolerance as well as sociodemographic data.
15866339|NCT03911102|Biological|DaxibotulinumtoxinA for injection|Intramuscular injection
15866340|NCT03911089|Other|UCD Anamix Infant|UCD Anamix infant with DHA and ARA is an amino acid based infant medical food containing only the essential amino acids, carbohydrate, fat, vitamins, minerals and trace elements.
15866341|NCT03911076|Biological|PVX-2|pNGVL4a-Sig/E7(detox)/HSP70 (naked DNA plasmid priming vaccine) TA-CIN (HPV16 L2E7E6 fusion protein booster vaccine)
15866342|NCT03911076|Other|Placebo|PBS and PGC
15867747|NCT03899779|Other|Online hypnotherapy|12 weeks treatment with online hypnotherapy
15866343|NCT03911063|Behavioral|CBT sessions|weekly 20-40 min CBT sessions during 8 weeks; Both the talking sessions (i.e., placebo) and CBT sessions will be performed via telemedicine either via a HIPAA secure telemedicine platform or the telephone based on the preference of the individual patient.
15866344|NCT03911063|Behavioral|Talking Sessions|20-40 min talking sessions (i.e., placebo) for 8 weeks; The placebo talking sessions will be performed by an acute care and palliative care board certified, New York State licensed nurse practitioner at the NYU Dysautonomia Center who is familiar with each FD subject enrolling in the study and an expert in familial dysautonomia. The NP will focus the 20-40 minute conversation on typical medical questions and concerns that the FD patient routinely calls the Center to discuss.
15866345|NCT03911050|Dietary Supplement|Apple consumption|Apple blends (600 g) One single dose
15866346|NCT03911050|Dietary Supplement|Control group|Breakfast without any apple-related products
15866347|NCT03911037|Drug|G-CSF|G-CSF will be administered as prefilled syringes at a dosage of 5 μg/Kg subcutaneously every 12 hr for five consecutive days. Four such cycles will be administered at three monthly intervals.
15866348|NCT03911037|Drug|Placebo|Placebo ( prefilled syringe) filled with normal saline subcutaneously every 12 hr will be administered for five consecutive days. Four such cycles at 3 monthly intervals will be administered.
15866349|NCT03911024|Behavioral|HIV|At the completion of each EMA, participants in the intervention group (n=50) will receive messages that address:1) unsafe sexual behaviors, 2) alcohol/drug use, 3) PrEP interest, and 4) HIV testing. In addition, participants will have access to a button in the app that will link them to resources when/if they are the victim of sexual assault. Finally, intervention arm youth will be asked to set a behavioral goal related to HIV prevention during this session. Those goals will include increasing condom use, PrEP use, non-occupational post-exposure prophylaxis (nPEP) use, reducing number of sexual partners, not having sex with using drugs or drinking alcohol, avoiding IV drug use, getting testing for HIV, and testing and treating sexually transmitted infections (STIs) as needed
15866350|NCT03911024|Behavioral|General health|Participants in the attention control condition (n=50) will answer the same EMA items as the Intervention group. However, the intervention messages will contain content related to nutrition, physical activity, sleep hygiene, and tobacco use. Finally, control arm youth will be asked to set a behavioral goal related to general health during this session.Those goals will include getting 7+ hours of sleep, eating >= 5 servings of fruits or vegetables, not using tobacco products, exercising at least 60 minutes.
15866351|NCT03911011|Other|Fresh air|Fresh air insufflation of 2 L/min toward mouth/nose.
15866352|NCT03910998|Drug|Rocuronium IV bolus 0.1 mg/kg guided by TOF that must remain between 1-3 during surgery|Bolus of rocuronium 0.1 mg/kg at the discretion of anesthetist to keep the TOF between 1-3 out of 4 during surgery
15866353|NCT03910998|Drug|Rocuronium IV bolus 0.1 mg/kg guided by TOF 0/4 and PTC≤ 2|Bolus of rocuronium 0.1 mg/kg IV will be given during surgery for a TOF 0/4 and a PTC ≤ 2 (parameters measured every 10 minutes).
15866354|NCT03910985|Drug|Duovent HFA|bronchodilation
15866355|NCT03910972|Biological|Sm-TSP-2/Alhydrogel® vaccine|The Sm-TSP-2/Alhydrogel® candidate vaccine contains recombinant Sm-TSP-2 adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10mM imidazole buffer containing 2mM phosphate and 15% sucrose, with pH 7.4 ± 0.1. The final concentrations of Sm-TSP-2 and Alhydrogel® in the drug product are 0.1mg/ml and 0.8mg/ml respectively.
15866356|NCT03910972|Biological|Sm-TSP-2/Alhydrogel® vaccine plus AP 10-701|The Sm-TSP-2/Alhydrogel® candidate vaccine co-administered with the immunostimulant, AP 10-701. b) AP 10-701, also known as Gluco-Pyranosylphospho-Lipid A Aqueous Formulation (GLA-AF), is a Toll-like Receptor-4 agonist. Point-of-injection formulations with this immunostimulant will be prepared immediately prior to vaccination by adding an appropriate volume of AP 10-701 to Sm-TSP-2/Alhydrogel® and withdrawing an appropriate volume to administer the desired amount of Sm-TSP-2 plus 5µg GLA-AF.
15866357|NCT03910972|Biological|ENGERIX-B Hepatitis B Vaccine|Recombinant hepatitis B vaccine containing 10 mcg recombinant hepatitis B surface antigen per dose
15866358|NCT03910959|Other|Animal-assisted therapy|Therapy in the presence and with interaction with an animal. Involved animals can be all species that live at REHAB Basel and are part of the AAT program. All animals are trained for the specific service with vulnerable patients.
15866359|NCT03910959|Other|Conventional therapy|Parallelled conventional therapy sessions (treatment as usual)
15866360|NCT03910946|Drug|Tuberculin, Purified Protein 5Unt/0.1 mL Solution|Tuberculosis (diagnosis)-Tuberculin, purified protein derivative (PPD) is indicated as a diagnostic aid in the detection of Mycobacterium tuberculosis infection. It is also indicated when BCG vaccination or isoniazid prophylaxis is being considered
15866361|NCT03910933|Other|elearning patient information|The videos will standardize patient teaching about anticoagulants, warfarin, INR testing, and warfarin safety for Patient Self-Testing, and Patient Self-Management. eKITE, will provide a user-friendly interface to provide health education about anticoagulation. eKITE will teach concepts to the patient, facilitate sustained patient knowledge (6 month evaluation), reduce stress associated with learning, actively engage patients in their anticoagulant management (preference, satisfaction and knowledge).
15866362|NCT03910907|Drug|Comparison of two standard of care regimens|Treatment according to results of laboratory detection of resistance markers
15866363|NCT03910881|Other|Open-platform patient support system (PSS) app|The PSS app enables tracking and visualization of patient-selected health outcomes and sharing of select outcomes with family and providers. The CF clinical team and the family jointly decide which aspects of daily life to track, how often, and the content and frequency of patient-generated reports. Examples of daily care that can be tracked include symptoms (respiratory, gastrointestinal, pain), energy level, appetite, sleep, exercise, mood, medications, therapies, school/work attendance. Prior to a clinic visit, the patient/family generates a report of the outcomes they have been tracking, to help prepare for the visit and identify successes and areas of struggle. This information facilitates meaningful conversations during the visit and promotes shared decision-making. Patients/families can view their progress at any time and share selected outcomes with family and friends as often as desired.
15866364|NCT03910855|Behavioral|Mindfulness Based Intervention|The mindfulness-based intervention consists of four 2-hour sessions covering various mindfulness techniques (e.g. mindfulness of breath, body and movement, senses and informal practice, and empathy and compassion) that pertain to stroke survivors and their family caregivers. Participants will be provided handouts for the information covered during these talks and discussions.
15866365|NCT03910855|Other|Health Education Program|The health education program consists of four 2-hour sessions covering various health topics (e.g. diet, nutrition and exercise) that pertain to stroke survivors. Participants will be provided handouts for the information covered during these talks and discussions.
15866366|NCT03910842|Biological|CD19-TriCAR-T/SILK|A conditioning chemotherapy regimen of fludarabine and cyclophosphamide may be administered, followed by a single infusion of CD19-TriCAR-T cells or 4 repeat infusions of CD19-TriCAR-SILK cells.
15866367|NCT03910829|Behavioral|Action Observation|Action observation training
15866368|NCT03910829|Behavioral|Motor Imagery|Motor imagery protocol
15866369|NCT03910829|Behavioral|Placebo Action Observation|Placebo Action Observation
15866370|NCT03910803|Drug|Brodalumab|"Brodalumab is a human monoclonal IgG2κ antibody directed against human interleukin-17 receptor A (IL-17RA). It is expressed in a Chinese Hamster Ovary (CHO) cell line. Brodalumab is comprised of 1312 amino acids and has an estimated molecular mass of 144,000 Daltons.
~Brodalumab Injection is a sterile, preservative-free, yellow solution, delivered via subcutaneous injection. . Each Brodalumab single dose prefilled syringe delivers 1.5 mL of solution containing 210 mg of brodalumab formulated in glutamate (6.5 mg), polysorbate 20 (0.15 mg), proline (36 mg), and Water for Injection, USP at pH 4.8."
15866371|NCT03910790|Device|19 gauge needle liver biopsy|Obtaining liver tissue with a 19 gauge core needle and whether a good core biopsy can be obtained without the use of suction and secondly to determine the diagnostic yield and safety of 19 gauge core needle for liver biopsy.
15866372|NCT03910777|Diagnostic Test|Early Warning Score|National early warning score (NEWS) is another early warning scoring system recommended by the Royal College of Physicians in London to detect early clinical deterioration in hospitalized patients
15866373|NCT03910764|Other|no intervention|Investigators review patients' medical records and collect personal data, underlying diseases, indwelling catheter duration, laboratory data, diagnosis, treatment and prognosis.
15866374|NCT03910751|Device|Transcatheter Aortic Valve Implantation with ACURATE Neo Aortic Bioprosthesis|Transfemoral TAVI using the Boston Scientific ACURATE Neo Aortic Bioprosthesis
15866380|NCT03910725|Other|Electrocardiographic imaging|ECGi is a non-invasive body surface mapping technique that collects electrocardiographic data using 252 leads, and combines it with subject specific anatomic data acquired from cross sectional imaging to recreate epicardial electrograms.
15866381|NCT03910712|Drug|Pyrotinib|Pyrotinib were administered 400 mg orally daily. Oral administration within 30 minutes after breakfast, and continuous administration for 21 days for 1 cycle.
15866382|NCT03910712|Drug|Trastuzumab|Trastuzumab were administered every 3 weeks intravenously (8 mg/kg loading doses followed by 6 mg/kg maintenance doses).
15866383|NCT03910712|Drug|Aromatase inhibitor|The investigator chose an aromatase inhibitor (either anastrozole, letrozole or exemestane 1 mg/2.5 mg/25 mg), once daily, oral.
15866384|NCT03910699|Device|Three-row circular stapler|Para-aortic lymph node dissection, inferior mesenteric artery skeletonisation and ligation below left colic artery origin, nerve-preserving total mesorectal excision, rectum division with a linear stapler, sigmoid colon division and circular stapler envil fixation with a purse-string suture, end-to-end colorectal anastomosis creation with a three-row circular stapler, defunctioning colostomy is performed.
15866385|NCT03910699|Device|Two-row circular stapler|Para-aortic lymph node dissection, inferior mesenteric artery skeletonisation and ligation below left colic artery origin, nerve-preserving total mesorectal excision, rectum division with a linear stapler, sigmoid colon division and circular stapler envil fixation with a purse-string suture, end-to-end colorectal anastomosis creation with a two-row circular stapler, defunctioning colostomy is performed.
15866386|NCT03910686|Combination Product|Transcranial magnetic stimulation and cognitive behavioral therapy|Transcranial magnetic stimulation on different side with/without cognitive behavioral therapy
15866387|NCT03910673|Drug|Fosfomycin disodium|Fosfomycin (a phosphonic acid derivative) formulated as a disodium salt.
15866389|NCT03910647|Drug|pantoprazole|effect of this drug on renal function
15866390|NCT03910634|Drug|Fluorouracil|1.33g/body surface QW1, continuous intravenous infusion for 72 hours, repeated for 4 weeks
15866391|NCT03910634|Radiation|Intensity modulated radiation therapy|Radiotherapy for 5-6 weeks，50-60Gy
15866392|NCT03910634|Drug|carboplatin|Carboplatin (AUC 2), QW1, intravenous drip, repeat for 4 weeks
15866394|NCT03910608|Device|MagPro X100 device (MagVenture, Farum, Denmark)|Each cPAS experimental session contained 100 pairs of stimuli at 0.2 Hz. The experimental conditions differed in the interstimulus interval of the paired pulses. DLPFC stimulation precedes IPL/MPFC stimulation by 10 ms (DLPFC+10) or by 4 ms (DLPFC+4), and IPL/MPFC stimulation precedes DLPFC stimulation by 4 ms (IPL/MPFC+4) or by 10 ms (IPL+10).
15882779|NCT03783442|Drug|Paclitaxel|175 mg/m2 IV on Day 1 Q3W
15866396|NCT03910582|Procedure|personalized frozen-thawed embryo transfer|The blastocysts were delayed or advanced transferred after ovulation depending on the endometrium dating in RIF group
15866397|NCT03910582|Procedure|routine frozen-thawed embryo transfer|The blastocysts were transferred 5 days after ovulation regardless of endometrium dating in control group.
15866398|NCT03910556|Drug|Propofol|intraoperative factors
15866399|NCT03910543|Drug|Tofacitinib 5 mg twice daily|Tofacitinib will be administered at a dose of 5 mg twice daily
15866400|NCT03910530|Drug|Retifanlimab|Part 1: INCMGA00012 500 mg every 4 weeks administered intravenously over 60 minutes.
15866401|NCT03910530|Drug|INCB001158|Part 1: INCB001158 75 or 100 mg twice daily administered orally.
15866402|NCT03910530|Drug|Retifanlimab + INCB001158|Part 2: INCB001158 at the recommended Phase 2 dose selected from Part 1 in combination with INCMGA00012 .
15866403|NCT03910517|Other|No intervention|No intervention
15866404|NCT03910504|Drug|Rocuronium 0.3 mg*kg|Patients randomized to the control group will receive rocuronium at 0.3 mg*kg ev bolus at the induction of anesthesia.
15866405|NCT03910504|Drug|No Rocuronium|Patients randomized to the interventional group will not receive neuromuscular blockade at the induction of anesthesia.
15866406|NCT03910491|Behavioral|PriCARE|PriCARE is a group parent training program designed to improve child behavior, improve parent-child relationships, and decrease stress for parents. PriCARE emphasizes the 3 Ps (Praise, Paraphrase, and Point-out-Behavior). The training initially focuses on parenting skills including giving attention to the child's positive behaviors and ignoring minor misbehaviors. The second phase of training includes teaching techniques for giving children effective commands to set age-appropriate limits. The PriCARE curriculum also includes trauma and stress education components in order to contextualize the use of these skills with the types of behaviors and problems demonstrated by many children who have experienced psychosocial adversity and chronic familial stress. Throughout the curriculum, caregivers are encouraged to practice the skills. PriCARE has been evaluated in the primary care setting and has shown promise. There have been limited studies on PriCARE for foster caregivers.
15866407|NCT03910478|Device|DBS Self-Collection Kit|Kit for self-collection of Dried Blood Spot (DBS) samples
15866408|NCT03910478|Other|Standard Control Strategy|Standard of care with office-based testing.
15866409|NCT03910452|Drug|Busulfan|3 days of IV Busulfan. An alkylating chemotherapeutic agent determined to have broad myelosuppressive effects. On this study is being used as part of conditioning regimen for myelosuppressive properties as per package insert and standard of care.
15866410|NCT03910452|Drug|Alemtuzumab|5 days of IV Alemtuzumab. A humanized monoclonal antibody directed against CD52 (which is abundantly expressed on all human lymphocytes), and causes T cell activation in vitro as well as complement-mediated lysis and antibody-dependent cellular toxicity. For this study, being used as part of the conditioning regimen per package insert and standard of practice.
15866411|NCT03910452|Drug|Cyclophosphamide|2 days of IV Cyclophosphamide. This is an antineoplastic, and for this study is bine used for its immunosuppressive mechanism of action per package insert and standard of care
15866412|NCT03910452|Drug|Sirolimus|Post Peripheral blood stem cell infusion. It is used for its immunosuppressive mechanism of action.
15866413|NCT03910452|Radiation|Total Body Irradiation|2 fractionated doses on -2 day. It is used for its immunosuppressive mechanism of action. It is SOP for conditioning for transplant.
15866414|NCT03910452|Biological|Allogeneic peripheral blood stem cell|IV infused donor peripheral blood stem cell. Stem cells are cells that give rise to the blood cells - red blood cells that carry oxygen, white blood cells that help the body to fight infections, and platelets that help make the blood clot. Collected and infused per the standard of operating procedures established by the Department of Transfusion Medicine.
15866415|NCT03910439|Biological|Avelumab|Avelumab 800 mg intravenous (IV) over 60 minutes (+/- 20 minutes) on days 1 and 15 of each 28-day cycle
15866416|NCT03910439|Radiation|External beam radiotherapy|5 gray (Gy) per fraction will be delivered on 5 consecutive treatment days for a total dose 25 Gy
15866417|NCT03910426|Other|Blood sampling|Blood is sampled before a midweek dialysis session once every year with a maximum of 3 samples in total.
15866418|NCT03910426|Other|Nails collection|At the occasion of the blood sampling, finger nails are cut and collected.
15866419|NCT03910426|Other|Stool collection|At the occasion of the blood sampling, patients are asked to bring a stool sample.
15866420|NCT03910426|Other|Physical Functioning|A subgroup of patients are asked to perform some physical tests.
15866421|NCT03910426|Other|Sleep|A subgroup of patients are asked to sleep 2-3 nights with a Motionwatch (Actigraphy) to recording their arm movements.
15866423|NCT03910400|Diagnostic Test|Computation of quantitative flow ratio|"After stents were implanted whenever technically possible in the STEMI patients, the investigators created a temporary artificial stenosis inside the stent by partially inflating a balloon catheter during pharmacologic hyperemia.
~Computation of QFR was performed offline, using AngioPlus system(Pluse medical imaging technology, Shanghai, China). In the first step, 2 diagnostic angiographic projections with the artifical stenosis, at least 25° apart, were selected and 3D reconstruction of the interrogated vessel without its side branches was performed. Then, the software computed the QFR."
15866427|NCT03910374|Procedure|Dural closure|Evaluation of the safety and effectiveness of autologous blood-derived products (L-PRF and fibrinogen) compared to the fibrin sealants as an adjunct for dural repair
15866428|NCT03910361|Drug|Evogliptin|evogliptin 5mg tablet qd + placebo tablet matching to pioglitazone 15mg qd
15866429|NCT03910361|Drug|Pioglitazone|pioglitazone 15mg tablet qd + placebo tablet matching to evogliptin 5mg qd
15866430|NCT03910348|Device|Whole-body vibration exercise|The WBV training consisted of a high frequency (30-40 Hz) vibration stimulus at a low setting on a Power Plate pro5 vibration platform (Performance Health Systems, LLC, Northbrook, IL, USA).
15866431|NCT03910348|Other|High-impact exercise|In the high-impact exercise program, the patients were asked to jump using a jump-rope at the beginning of each session
15866432|NCT03910335|Diagnostic Test|LSS Screen|Patients will fill out a questionnaire with 13 questions related to presence or absence of clinical symptoms of lumbar spinal stenosis (neurogenic claudication)
15866433|NCT03910322|Dietary Supplement|Bif195|Two different doses of the bacterial strain Bif195 is compared to placebo
15866434|NCT03910322|Dietary Supplement|Placebo|Placebo
15866435|NCT03910309|Device|TLIF with Titan TT/TO interbody cage|fusion surgery
15866436|NCT03910296|Behavioral|Acceptance & Commitment Therapy|ACT is a unique, third-wave therapy that uses metaphors and experiential exercises to encourage contact with previously avoided thoughts, feelings, and behaviors.
15866437|NCT03910257|Behavioral|nutrition education module|12 activities of nutrition education module will deliver by the teacher. The activities consists of coloring my meal plate, playing pictures, story telling: Zizi and Ziko, pictures station, fruits and vegetables card, cooking class, planting bean sprouts, field visit to fruits and vegetables garden, making collages, dot to dot, watching video, making healthy snacks
15866438|NCT03910244|Drug|Pomalidomide Oral Product|Pomalidomide, a third generation derivative of thalidomide, given orally at a starting dose of 4 mg/day for days 1-28 of six 28-day cycles. The dose may be reduced to 3 or 2 mg/day based on specific AE criteria.
15866439|NCT03910244|Drug|Placebo oral capsule|Matching placebo will be given.
15866440|NCT03910231|Drug|Tolvaptan Oral Tablet|Tolvaptan, to block V2R
15866441|NCT03910218|Behavioral|NCM4HIV|Participant will receive NCM4HIV intervention which includes Personalized HIV prevention education, behavior goal-setting,behavioral self-monitoring, PrEP eligibility screening,PrEP/nPEP services (labs, medication), healthcare planning/coordination, MI counseling approach, assisting with cognitive appraisals (clarifying misconceptions),promoting health seeking and coping behaviors that incorporate the situational, personal, social, and resource needs affecting health
15866442|NCT03910218|Behavioral|Usual Care|Participant will receive usual care which includes Housing, food, and clothing needs,health assessment, basic healthcare, limited anticipatory guidance, mental health counseling, substance use treatment referrals, PrEP/nPEP referrals
15866443|NCT03910205|Diagnostic Test|ELISA|Enzim linked immunoabsorbant assay
15866444|NCT03910192|Behavioral|Mindfulness-based coaching|16 week mindfulness-based protocol focused on home-based and weekly group practice of mindfulness meditation and mindful movement.
15866445|NCT03910192|Behavioral|Dietary cardiovascular risk reduction coaching|Regular in-person meetings, phone calls, or email from study coordinator instructing them on how to integrate exercise and dietary changes in their lifestyle to reduce their risk of future cardiovascular events.
15866446|NCT03910166|Procedure|drug-coated balloon catheter（Orchid, Acotec）|After predilation, using drug-coated balloon catheter to cover the whole treated segment
15866447|NCT03910166|Procedure|Intracranial artery stent system（APOLLO）|stent assisted angioplasty
15866448|NCT03910153|Dietary Supplement|MSPrebiotic|MSPrebiotic digestion resistant starch from potatoes (30 g) will be mixed in 1 glass (approximately 250 mL) of non-heated fluid or non-heated semi solid food and consumed. If the subject is on any medications, the potato resistant starch will be administered either 2 hours before medications or 2 hours after participants have taken their medications.
15866449|NCT03910153|Other|Placebo|Corn starch (30 g) will be mixed in 1 glass (approximately 250 mL) of non-heated fluid or non-heated semi solid food and consumed. If the subject is on any medications, the corn starch will be administered either 2 hours before medications or 2 hours after participants have taken their medications.
15866450|NCT03910140|Procedure|TILA-TACE treatment|TACE was performed through the transfemoral route using a 5-Fr catheter (Shepherd-hook modified Angiographic Catheter, HANACO Medical, Tian Jin, China ) that was advanced from celiac artery to common hepatic artery, proper hepatic artery, hepatic artery and ultimately to tumor feeding arteries which are defined by angiography. Then, a coaxial microcatheter (2.8 Fr Marguerite II, ASAHI INTECC GMA CO., LTD, Nagoya, Japan) was selectively inserted through a 5-Fr catheter into the tumor feeding artery, into which, 5% sodium bicarbonate was infused alternatively with doxorubicin-lipiodol emulsion. Finally, the artery was embolized with PVA (Embosphere®, BioSphere Medical, Paris, France) and microcoil ( Tornado ®, COOK Medical, USA).
15866451|NCT03910127|Drug|TQB2450|TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
15866452|NCT03910127|Drug|Anlotinib|a multi-target receptor tyrosine kinase inhibitor
15866453|NCT03910127|Drug|Anlotinib|matching placebo
15866454|NCT03910114|Drug|Magnevist|GBCA enhancement
15866455|NCT03910114|Drug|Dotarem|GBCA enhancement
15866456|NCT03910114|Drug|Gadovist|GBCA enhancement
15866457|NCT03910101|Procedure|Hand surgery and intensive rehabilitation|Spasticity-correcting upper-limb surgery comprised lengthening of tendons, release of muscles, and occasionally correction of deformities. Rehabilitation starts the first post-operative day and comprised physiotherapy and occupational therapy. Patients are also taught a home-training program. Up to 1 week of intensive in-hospital rehabilitation followed 3 weeks after surgery and a new home-training program are designed.
15866458|NCT03910088|Drug|Pregabalin 100Mg Oral Cap|giving a drug to relieve post-dural puncture headache
15866459|NCT03910088|Drug|Hydrocortisone|Giving drug to relieve post-dural puncture headache
15866460|NCT03910088|Drug|Acetaminophen|giving a drug to relieve post-dural puncture headache
15866461|NCT03910088|Other|oral fluids|giving oral fluids to maintain good hydration
15866462|NCT03910088|Drug|Caffeine|giving a drug to relieve post-dural puncture headache
15866463|NCT03910088|Drug|Diclofenac|giving a drug to relieve post-dural puncture headache
15866464|NCT03910075|Behavioral|I-ACQUIRE - High Dosage|Children in this group will receive 6 hours of I-ACQUIRE therapy daily, 5 days a week for 4 consecutive weeks. Treatment is delivered in the home or homelike setting by a study trained I-ACQUIRE pediatric therapist.
15866465|NCT03910075|Behavioral|I-ACQUIRE - Moderate Dosage|Children in this group will receive 3 hours of I-ACQUIRE therapy daily, 5 days a week for 4 consecutive weeks. Treatment is delivered in the home or homelike setting by a study trained I-ACQUIRE pediatric therapist.
15866466|NCT03910075|Behavioral|Usual & Customary Treatment (U&CT)|Children in this group will receive the same U&CT that they had been receiving prior to the baseline assessment. The type and dosage of treatment(s) will be documented weekly.
15866467|NCT03910062|Procedure|Lower limb angiography via the reperfusion cannula and NIRS monitoring|Data collection only (lower limb angiography, lower limbs NIRS values).
15866468|NCT03910049|Drug|Indocyanine Green|Indocyanine green will be administered intravenously to patients enrolled in this study after the completion of total thyroidectomy in order to assess the visibility of parathyroid glands and to assess the possible correlation of ICG score with post-operative parathormone levels in order to predict post-thyroidectomy hypoparathyroidism.
15866469|NCT03910036|Biological|platelet rich plasma|Thirty ml of venous blood was taken from every patient and collected in sodium citrated sterile tubes. Platelet concentrates obtained by adjusting centrifuge at 1800 rpm for 15 min to separate erythrocytes, then at 3500 rpm for 10 min to concentrate the platelets. The preparation was done by a single laboratory technician. Thus 5 ml of PRP were obtained, 0.2 mL of 10% calcium chloride was added to the final product to activate the platelets and injected immediately without storage.
15866470|NCT03910023|Other|Usual care comporting a home-exercise program (UCHE)|"The UCHE intervention will correspond to current practice (including the continuation of previous treatments, if applicable) as decided by the attending physician. The patient will also be provided with a practical guide on how to manage back pain (the back book), including a recommended home exercise program."
15866471|NCT03910023|Other|Spa therapy|the spa-therapy intervention consists of 18 consecutive days of spa-therapy (excepting Sundays), that must occur with 60 days of randomisation. The latter will combine mineral water with physical and hydrotherapeutic treatments, including massages, heat and water exercises.
15866472|NCT03910010|Drug|Placebos|Positive treatment expectations will be induced by giving participants capsules containing inert material and telling them that the capsules contain an effective drug that has been approved for treating Chronic Pain. They will be requested to take two capsules four times a day and report their pain on paper forms organized as a calendar or on REDCap.
15866473|NCT03909984|Device|Nightwatch|Nocturnal monitoring for 2 months with three different seizure detection devices.
15866475|NCT03909958|Other|Electroacupuncture+Routine rehabilitation training Group|"Electroacupuncture： Major acupoints: Jiaji points. With urinary and stool dysfunction:+Shenshu (BL23) ,Huiyang(BL35).
~Localization:Jiaji points of the upper 1 and the lower 1 segment of the Spinal cord injury plane, a total of 4 points.
~Operation: Insert Jiaji points By using Hwato-brand disposable acupuncture needles(0.30mm*50mm), with 0.5 inch from the median line and a depth of 50 to 60mm with perpendicular insertion.Then, participants will receive electroacupuncture treatment by connecting Han's pain irritant instrument (HANS100A) for 30min with the stimulation frequency of 2 /100 Hz and intensity of 1-2mA. Once a day, 5 days a week and rest 2 days, a week is one course and the duration need 12 courses.
~Routine rehabilitation training:
~Same as Routine rehabilitation training Group."
15866476|NCT03909958|Behavioral|Routine rehabilitation training Group|"Routine rehabilitation training:
~Participants with good spinal stability will receive sitting training as early as possible, and will carry out standing training if participants had no adverse reactions (postural hypotension, etc.) after sitting training. Muscle strength training will be performed in recovery phase, and functional movement training will be selected according to participants' conditions. Functional movement training and transfer training will be performed for 20min each time and once a day;Standing and walking training, 2 times a day, 30min each time."
15866477|NCT03909945|Dietary Supplement|Annona muricata|Patients with prehypertension or stage 1 hypertension, in dietary measures, will received daily one tablet of 796 mg of aqueous extracts of Annona muricata leaves. During 60 days
15866478|NCT03909932|Other|Observational study : no intervention|Observational study : only exporting data
15866479|NCT03909919|Procedure|Standard Care or Usual Clinical Practice|The guidelines for the management according to the heart failure in primary care will be the treatment guidelines for the Standard Care.
15866480|NCT03909906|Drug|Euphytose®|(50mg Valeriana officinalis L., 40mg Passiflora incarnate L., 10mg Crataegus sp., 10mg Ballota nigra L.)
15866481|NCT03909906|Drug|Placebo Oral Tablet|Placebo comparator
15866483|NCT03909880|Device|kinesio tape|Kinesio taping(kinesio taping;kinesio holding corporation,USA) is given between the pretest and the posttest. The taping is operated by a physical therapist who is the co-host of this experiment in 614 room, Research Building, National Yang-Ming University. Posttest will be started immediately after taping. After posttest, kinesio tape will be removed. There are 3 types of taping conditions. Kinesio tape is pulled from 5 cm distal wrist joint line to medial epicondyle and 5 cm at both ends of the head and tail without tension .All participants will receive all conditions of taping. They will be randomly assigned to any taping conditions. In order to wash out the effect of taping, the interval of any condition is at least 7 days.
15866484|NCT03909854|Procedure|mode of mechanical ventilation|Adaptive Pressure Control mechanical ventilation is a dual controlled mode that is designed to auto-control flow and minimize inspiratory pressure while delivering a provider-determined tidal volume. Assist Volume Control mechanical ventilation is a mode in which the respiratory care provider determines patient tidal volume and flow.
15866485|NCT03909841|Behavioral|Cambridge Neuropsychological Test Automated Battery (CANTAB)|Cognition using Cambridge Neuropsychological Test Automated Battery (CANTAB)
15866486|NCT03909841|Other|Chinese (Hong Kong) 12-item Short-Form Health Survey (version 2)|Quality of Life using Chinese (Hong Kong) 12-item Short-Form Health Survey (version 2)
15866487|NCT03909815|Device|Dual mobility cup|Patients with a displaced femoral neck fracture eligible for THA receive a dual mobility cup, as opposed to a standard cup in the control group.
15866488|NCT03909815|Device|Standard cup|Patients with a displaced femoral neck fracture eligible for THA receive a standard cup, as opposed to a dual mobility cup in the experimental group.
15866489|NCT03909802|Behavioral|Self-and family management of diabetic foot ulcers programs|The intervention combines self-management and family management focusing on behavioral changes in patients with diabetic foot ulcers. Self-management focuses on intensive health education of physical activities, diet, medication, foot care, and blood glucose control. Family management focuses on problem-solving, establishing roles, and effective involvement in providing care amid individuals suffering DFU.
15866491|NCT03909789|Dietary Supplement|Plant based bioequivalent Nitrate supplementation|The nitrate supplement consists of nitrate-rich beetroot extract 20mg, thiamine mononitrate 90mg, potassium nitrate 480mg, ascorbic acid 150mg, folic acid 200mcg, methylcobalamin 200mcg, calcium 115mg, pomegranate fruit extract 5mg and green coffee bean extract 115mg.
15866492|NCT03909789|Dietary Supplement|Placebo|Placebo
15866493|NCT03909776|Drug|Cisplatin|Cisplatin was administered intravenously or intraarterially after adequate IV hydration. For IA infusion, cisplatin was given via insertion of a catheter percutaneously by using the Seldinger technique through the brachial or femoral artery under anesthesia and usually at 120 mg/m2 as a 3-h/6-h continuous infusion; while for IV administration, it was given at 100-120 mg/m2 as 6-h infusions.
15866494|NCT03909763|Drug|Berberine plus danazol|Oral BBR (0.3g thrice daily) plus oral danazol (200 mg twice daily) for 16 weeks
15866495|NCT03909750|Procedure|Lipoaspiration|Close syringe microcannula harvesting subdermal fat and perivascular stem/stromal cells
15866496|NCT03909750|Procedure|AD-cSVF|Isolation of AD-cSVF
15866497|NCT03909750|Procedure|Normal Saline IV|Normal Saline IV containing AD-cSVF
15866498|NCT03909737|Drug|Azithromycin to pregnant women|Azithromycin to pregnant women at antenatal care visits and during delivery
15866499|NCT03909737|Drug|Azithromycin to infants|Azithromycin to infants at 6 and 14 week EPI visits
15866500|NCT03909737|Other|Placebo to pregnant women|Placebo to pregnant women at antenatal care visits and during delivery
15866501|NCT03909737|Other|Placebo to infants|Placebo to infants at 6 and 14 week EPI visits
15866502|NCT03909737|Other|No intervention to pregnant women|No intervention to pregnant women
15866503|NCT03909724|Drug|Sunitinib Malate|After study inclusion, patients will be randomized (1:1) via a centralized randomization system to receive either oral sunitinib (700 mg once every 2 weeks) or TAS-102 (35 mg per square meter, twice daily, 5 days a week, with 2 days of rest, for 2 weeks, followed by a 14-day rest period). Patients will receive treatment until disease progression or discontinuation due to unacceptable toxic effects, withdrawal of consent, or other reason.
15866504|NCT03909724|Drug|TAS 102|After study inclusion, patients will be randomized (1:1) via a centralized randomization system to receive either oral sunitinib (700 mg once every 2 weeks) or TAS-102 (35 mg per square meter, twice daily, 5 days a week, with 2 days of rest, for 2 weeks, followed by a 14-day rest period). Patients will receive treatment until disease progression or discontinuation due to unacceptable toxic effects, withdrawal of consent, or other reason.
15866505|NCT03909698|Other|Blood and urine sampling|During a period of maximum 6 days blood is sampled at different time points and urine is collected during documented time intervals.
15866506|NCT03909685|Behavioral|Mobile Mental Health App|The Mobile Mental Health App is an app that utilizes artificial intelligence to identify symptoms and provides targeted, tailored solutions for its users.
15866507|NCT03909672|Other|Cupping Therapy|application of cupping therapy with two acrylic type 1 cups (4.5 cm internal diameter, Dong Yang ® brand) with a distance of 3 cm each cup, parallel to the L1 to L5 vertebrae bilaterally
15866508|NCT03909659|Behavioral|Dietary sodium reduction|A supply of a reduced-sodium added-potassium salt substitute
15866509|NCT03909646|Drug|Methyl Aminolevulinate (Mal) for Topical Administration, 16.8%, 1 Gram|A layer of methylaminolevulinc acid 160 mg/g cream (about 1 mm thick) is applied to the lesion, with a clinical margin of 5-10 mm surrounding of normal skin and then covered by an occlusive dressing. After 3 hours the occlusive dressing will be removed and the area is illuminated with Omnilux or Actilite (Galderma). After PDT the treatment site is covered again with the above mentioned occlusive dressings during 48 hours. Treatment is performed by an authorized nurse in the hospital. Two sessions should be administered with an interval of one week between sessions.
15866510|NCT03909646|Drug|5Fluorouracil|5-FU is applied on the treatment area by the patient in a thin layer twice daily during 4 weeks.
15866511|NCT03909646|Other|Surgical excision|Local anesthesia with lidocain 1% (1-2ml) will be used before performing standard surgical excision with 5 mm safety margin followed by routine histological examination. The skin will be closed using cutaneous sutures, which will be removed after 1-2 weeks. The surgical excision will take place in the hospital by the treating physician
15866512|NCT03909633|Behavioral|a series of tests|all patients in every group will do a series of tests,including DSST、DST、MoCA、WCST、HADS
15866513|NCT03909620|Diagnostic Test|Low-dose computed tomography of chest|Eligible subjects will undergo a single round of LDCT screening. The LDCT will be considered as positive if a solid nodule or part-solid nodule of size ≥6 mm or non-solid nodule of size ≥20 mm is identified. Evaluation of positive nodules will be performed as per existing standard recommendations
15866514|NCT03909607|Drug|Ketamine 0.75 mg/kg|Patients with moderate to severe pain will receive Ketamine at a dose of 0.75mg/kg
15866515|NCT03909607|Drug|Ketamine 1.0 mg/kg|Patients with moderate to severe pain will receive Ketamine at a dose of 1.0 mg/kg
15866516|NCT03909607|Drug|Ketamine 1.5 mg/kg|Patients with moderate to severe pain will receive Ketamine at a dose of 1.5 mg/kg
15866517|NCT03909594|Drug|Bupivacaine|Bupivacaine
15866518|NCT03909594|Drug|Ketamine|Ketamine
15866519|NCT03909581|Procedure|Endoscopic coronary arterial bypass|is defined, for the purposes of this trial, as a planned off-pump minimally invasive (sternal-sparing), isolated LIMA-LAD revascularization (50 participants)
15866520|NCT03909581|Procedure|Percutaneous Coronary Intervention|will be performed using standard techniques at the discretion of the operator (50 participants)
15866521|NCT03909568|Procedure|Third molar surgery|Comparing complete removal of third molar with removal of crown only on contralateral side
15866522|NCT03909555|Other|Complications assessment|Records of cardiovascular diseases (CVD), carotid ultrasonography, electrocardiogram, echocardiography, fundus photography, urinary albumin excretion, Toronto Clinical Neuropathy Scale and Composite Autonomic Symptom Score.
15866523|NCT03909529|Drug|Digoxin 250 MCG Oral Tablet|The intervention is for study of drug drug interaction of digoxin when administered with spironolactone oral suspension
15866524|NCT03909529|Drug|Spironolactone 25 mg/ 5 mL S/F Suspension|The intervention is for study of drug drug interaction of digoxin when administered with spironolactone oral suspension
15866577|NCT03909100|Device|CoolSculpting® System|A treatment session is comprised of timed segments of cooling (treatment cycles) followed by 2 minutes of manual massage.
15867748|NCT03899779|Other|Online psychoeducation|12 weeks treatment with online psychoeducation
15866525|NCT03909516|Device|iovera°|"The iovera° device will be prepared by the trained Anesthesiologist User Guide. If at any time the device does not perform as expected the Investigator and Anesthesiologist will follow procedures as outlined in the User Guide. Start and end time will be recorded. Once localized anesthesia of the block area is achieved, the Anesthesiolgist, or designee, will complete the iovera° treatment. Upon completion of block, The Anesthesiologist or designee will assess the treatment areas for adverse events. Adductor Canal Block required, the formulation, or cocktail, of medications used are to be recorded in the medical record. Start and end time will be recorded.
~Local Infiltration Analgesia - 20cc 0.5% ropivicaine only"
15866527|NCT03909490|Other|Preference elicitation tool|Ranking tool to assess patient preferences for trigger finger treatment
15866528|NCT03909490|Other|handout|handout with information about trigger fingers
15866529|NCT03909477|Diagnostic Test|Hyperpolarized Xenon-129 MRI of the lungs|Participants will be imaged using MRI using hyperpolarized xenon-129 gas as a contrast gas
15866530|NCT03909477|Diagnostic Test|Computed Tomography (CT)|Participants will undergo a CT scan of the thoracic cavity
15866531|NCT03909477|Diagnostic Test|Pulmonary Function Tests (PFTs)|Participants will have their lung function evaluated using PFTs
15866532|NCT03909477|Diagnostic Test|Six Minute Walk Test (6MWT)|Participants >35 years of age will perform the six minute walk test as a measure of exercise capacity
15866533|NCT03909477|Diagnostic Test|Cardiopulmonary exercise testing (CPET)|Participants <35 will perform cardiopulmonary exercise testing as a measure of exercise capacity
15866534|NCT03909477|Diagnostic Test|Sputum analysis|Participants will provide a sputum sample that will be analysed for eosinophils
15866535|NCT03909477|Diagnostic Test|Blood analysis|Participants will have their blood drawn and analysed for eosinophil count.
15866536|NCT03909464|Device|Neurosensory testing with Pressure-Specified Sensory Device|Patients will have neurosensory function of hands and feet tested with the non-invasive Pressure-Specified Sensory Device.
15866537|NCT03909451|Drug|Sotagliflozin (SAR439954)|"Pharmaceutical form: tablet
~Route of administration: oral"
15866538|NCT03909451|Drug|Placebo|"Pharmaceutical form: tablet
~Route of administration: oral"
15866539|NCT03909438|Procedure|Endovascular Thrombectomy|Endovascular therapy includes direct mechanical thrombectomy or intravenous thrombolysis with mechanical thrombectomy. Endovascular Thrombectomy Device: Trepo trevor Retriever Device: SolitaireTM FR Revascularization Device
15866540|NCT03909412|Drug|Carfilzomib|Carfilzomib will be administered over 10 minutes for the 20 mg/m2 and 27 mg/m2 dose and over 30 minutes for all higher doses.
15866541|NCT03909412|Drug|Cyclophosphamide|Cyclophosphamide dosed at 2gm/m2 administered over 1 hour.
15866542|NCT03909412|Drug|Dexamethasone|Dexamethasone 40mg IV/PO to be administered as a premedication.
15866543|NCT03909412|Drug|Granulocyte Colony-Stimulating Factor|On day 7 subjects will initiate high dose G-CSF injections at 14mcg/kg daily (with a cap of 1440mcg daily).
15866544|NCT03909373|Other|PSFS|Patients will complete the patient specific functional scale. no intervention being administered
15866545|NCT03909360|Procedure|drainage tube|sub-hepatic drainage tube for laparoscopic cholecystectomy
15866546|NCT03909347|Behavioral|PLAN|The study intervention, PLAN is a multifaceted intervention led by trained CHW. It consists of two main components: dementia literacy education and phone counseling with navigation assistance through (1) 1-hour visit for dementia literacy education and (2)monthly counseling with navigation assistance
15866547|NCT03909347|Behavioral|Standard of Care|The investigators will refer control group participants to participants' primary physicians for follow-up and provide an Alzheimer's Association brochure about signs of dementia and dementia treatment, which is publicly available in Korean.
15866548|NCT03909334|Drug|Osimertinib|Osimertinib 80 mg orally on Day 1
15866549|NCT03909334|Drug|Ramucirumab|Ramucirumab 10 mg/kg intravenously (IV) over 60 minutes for first infusion and if tolerated subsequent infusions may be over 30 minutes
15866550|NCT03909321|Behavioral|Beach tennis training group|Beach Tennis Training Group (BTG) will perform two sessions of 40-60 min of beach tennis during 12 weeks. BT sessions will be composed by a warm up of 5-10 min of BT technical exercises (i.e., serve, volley, forehand and backhand exercises) followed by 3 BT small games of 10-15 min each.
15866551|NCT03909308|Behavioral|Beach Tennis session|The Beach Tennis training session will be composed by a warm up of 5 min of BT in which technical exercises (i.e., serve, volley, forehand and backhand) will be performed After that, 3 BT small games of 12 min with a 2 minute interval between games using the conventional rules of sport will be performed. Before the session and after each small game, data regarding heart rate, blood pressure and rate perceived exertion will be recorded.
15866552|NCT03909295|Drug|LCZ696|Starting dose was either 50 mg b.i.d. or 100 mg b.i.d. largely depending on the last dose level taken by the patient at the time of completing PARAGON-HF and patient condition. The dose level was gradually up-titrated with the goal of reaching the target dose of 200 mg b.i.d. as soon as tolerated by the patient
15866553|NCT03909282|Procedure|Lumpectomy|Standard of Care surgery for DCIS (either lumpectomy or mastectomy)
15866554|NCT03909282|Radiation|Partial breast irradiation prior to surgery|Partial breast irradiation (PBI) will be delivered once aday for 5 days. The planned daily dose is 6 Gy prior to surgery (neo adjuvant)
15866555|NCT03909269|Device|Continuous glucose monitoring|Continuous glucose monitoring five times over 17 weeks
15866556|NCT03909269|Diagnostic Test|Glycaemic markers|Measurement of HbA1c by immunoassay (Roche) and chromatography (TOSOH), including glycated albumin and fructosamine.
15866557|NCT03909269|Radiation|Erythrocyte life span|Erythrocyte life span measured by Crom-51 labelling over 4 weeks
15866558|NCT03909269|Device|Carbon monoxide (CO)-rebreathing method|Measurement of total blood volume, plasma volume and erythrocyte volume
15866671|NCT03908229|Procedure|Trainee colonoscopy|Colonoscopy performed by trainee
15866559|NCT03909256|Other|NUTRI-HAB|"The rehabilitation program is a coordinated multidisciplinary effort involving several specialists e.g. clinical dietitians, nurses, physiotherapists, occupational therapists (responsible for dysphagia management in Denmark), psychologists and social workers.
~The program includes group sessions with patient education on how to handle the different aspects of living with eating problems and other late effects. Practical kitchen exercises, physical activity sessions and instruction in swallowing training are included. Individual counseling sessions with clinical dietitians and other health professionals (e.g. physicians) are offered depending on participants' needs.
~Participants stay at the premises and all meals throughout the day are served in the dining room or in the café. Foods of different textures and flavors are served to inspire participants and to allow them to experiment.
~Between the initial stay and follow-up participants are contacted twice by a clinical dietitian."
15866560|NCT03909217|Procedure|TECAS Procedure|"Location:
~Cranial electrical stimulation acupoints: Baihui (DU20) and Yintang (DU29).
~Auricular electrical stimulation zone: the distribution area of auricular branch of the vagus nerve.
~Two electrodes electric stimulation at a frequency of 4/20 Hz will be employed on the cranial acupoints and the auricular zone respectively. The TECAS treatment will consistent of two sessions per day (30 minutes) for 8 consecutive weeks."
15866561|NCT03909217|Drug|Escitalopram|Each subject shall receive oral administration Escitalopram (10-20mg/day, q.d.), as prescribed by clinical psychiatrist with respect to patients' conditions for 8 consecutive weeks.
15866562|NCT03909217|Drug|Insomnia medication|For patients with severe insomnia, stabilizers and benzodiazepines could be prescribed and must be recorded in the case report form.
15866563|NCT03909204|Procedure|LAPEC|Laparoscopic-Assisted Percutaneous Endoscopic Cecostomy: Initially, one to tree-laparoscopy port technique will be used, with hand placement of seroperitoneal sutures for cecal fixation. After than during colonoscopy a cecal position will be visualized and colonic lumen will be insuflated. After than the PEC tube will be introduced into the cecum using the dilators and sheath. Intravenous antibiotics will be given prior to the procedure and will continued parental temporary and later orally after catheter insertion. One weeks later, antegrade colonic enema will start during an out-patient visit including an educational training of the patient to the catheter manipulation. Antegrade enema solution will start at dose of 2ml/kg and will be increased up to 20ml/kg or a maximum dose of 2000 mL daily. Adjuvant of colonic motility stimulants are allowed during follow-up.
15866564|NCT03909191|Diagnostic Test|serum HBV RNA|serum HBV RNA level was determined by using HBV-SAT kit at different time point
15866571|NCT03909152|Drug|Onapristone ER|50 mg PO BID (with dosage adjustments) until POD, unacceptable toxicity or withdrawal of consent.
15866572|NCT03909152|Drug|Onapristone ER + Anastrozole|Onapristone ER Patients will take 50 PO BID in the form of two 20 mg tablets and one 10 mg tablet taken with food and water twice daily. Patients will be prescribed anastrozole 1mg PO QD. Anastrozole will be taken once daily in the AM with patients morning dose of onapristone ER.
15866574|NCT03909126|Biological|Boostrix administered during gestational diabetes screening|Boostrix administered during gestational diabetes screening
15866575|NCT03909126|Biological|Boostrix administered in high volume obstetric clinic|Boostrix administered in high volume obstetric clinic
15866576|NCT03909113|Dietary Supplement|amino acid based formula|amino acid based formula
15866672|NCT03908229|Procedure|Experienced physician colonoscopy|Experienced physician colonoscopy
15866578|NCT03909074|Biological|36-71 months old children-experimental EV71 vaccine.|Two doses experimental EV71 vaccine at the 0, 30 days vaccination schedule.
15866579|NCT03909074|Biological|36-71 months old children-control EV71 vaccine.|Two doses control EV71 vaccine at the 0, 30 days vaccination schedule.
15866580|NCT03909074|Biological|6-35 months old children-experimental EV71 vaccine.|Two doses experimental EV71 vaccine at the 0, 30 days vaccination schedule.
15866581|NCT03909061|Behavioral|Wheelchair Maintenance Training|Wheelchair Maintenance Training Program: WMTP training consists of three parts. It starts with an overview of basic wheelchair maintenance items, continues with the second section discussing how to inspect the parts of a wheelchair and finishes with the third section discussing how to perform wheelchair maintenance on a wheelchair. Throughout the course, there are videos and pictures demonstrating the activities discussed in the training program. Participants will also be informed when a repair requires professional assistance and where such assistance may be found.
15866582|NCT03909048|Behavioral|Interactive - Psychoeducation|Individuals will receive interactive psychoeducation in the lab over the course of a week period. Each session will take approximately 30 minutes.
15866583|NCT03909048|Behavioral|Non-interactive Psychoeducation|Individuals will receive non-interactive psychoeducation over the course of a week period. Each session will take approximately 30 minutes.
15866584|NCT03909035|Other|Medication therapy management|"The intervention is in the form of a pharmacist-led medication review aimed at detecting potentially inappropriate prescribing. It includes:
~A patient-pharmacist interview to collect comorbidities, medication, laboratory results, self-medication, adherence, medication patient's knowledge.
~A pharmacist's evaluation of the prescriptions based on the patient's conditions and on the current recommendations for clinical practice.
~Detailed feedback to the general practitioner.
~An appointment with the patient to explain the modifications made by the general practitioner (GP)"
15866585|NCT03909009|Device|rTMS + Neuronavigation|Repetitive Transcranial Magnetic Stimulation (Neuro-MS/D) + Neural Navigator
15866586|NCT03908996|Behavioral|Profile by Sanford weight management plan|The purpose of this study is to observe weight changes in patients who completed endometrial cancer treatment, are clinically overweight, and who participate in the Profile by Sanford weight management program. An exploratory purpose is to examine the bacterial content of the patient's gut by examining stool specimens before starting the Profile by Sanford weight management program and after 6 months of participation in the Profile by Sanford weight management program.
15866587|NCT03908983|Device|Kalios Implant|KALIOS is an adjustable annuloplasty ring, to be implanted by open surgery, having a hollow structure that comprises a flat rigid ring surrounding a deformable cage. The unique feature of KALIOS is that its annular shape and dimension can be finely adjusted percutaneously by an external actuator (three-balloon catheter) independently in the three areas corresponding to P1, P2 and P3
15866588|NCT03908970|Drug|1% OPA-15406|Twice daily
15866589|NCT03908970|Drug|Placebos|Twice daily
15866590|NCT03908957|Drug|Ga68-Dolacga Injection|Ga68-Dolacga Injection, 3.5±0.25 mCi, single dose iv
15866591|NCT03908944|Drug|Methadone|Individuals in this group will receive an identical anesthetic without the addition of remifentanil. They will be given methadone 0.2 mg/kg IV at the beginning of the anesthetic. A lidocaine bolus of 1.5 mg/kg will be given with induction of anesthesia followed by an infusion of lidocaine at 2 mg/kg/hr until the end of surgery.
15866592|NCT03908944|Drug|Standard of Care|Standard of Care patients will be given an infusion of remifentanil 0.15-0.25 mcg/kg/min as part of their intraoperative anesthetic regimen. The infusion will be maintained until the end of surgery and will be discontinued upon emergence. Prior to emergence, 100-200 mcg of fentanyl will be titrated for additional analgesia after emergence.
15866593|NCT03908931|Radiation|MRI|Follow up of osteochondral surgery by MRI and clinical examination
15866594|NCT03908918|Other|Mindfulness app|Mobile app-delivered mindfulness intervention delivered over 4 weeks.
15866595|NCT03908905|Diagnostic Test|Polysomnography|Sleep screening, neurocognitive assessment, activity monitoring questionnaires, blood sample
15866596|NCT03908892|Drug|zanthoxylum nitidum tincture|Local application with zanthoxylum nitidum tincture soaked blocks for the sick nail(s) for 30 minutes, twice a day.
15866597|NCT03908892|Drug|tetracycline ointment|Local use of 1% tetracycline ointment for the sick nail(s), 3 times a day
15866598|NCT03908879|Procedure|Standard intraosseous (IO) catheter confirmation procedure|The physician will evaluate the ability or inability of the intraosseous (IO) catheter to stand upright unassisted, the ability or inability to aspirate blood or bone marrow from the IO catheter, and whether or not there is visible or palpable extravasation of infusate from the IO catheter insertion site or surrounding subcutaneous tissue during IO catheter use.
15866599|NCT03908879|Procedure|Color flow Doppler intraosseous (IO) catheter confirmation procedure|The high frequency probe of a portable ultrasound with color flow Doppler is placed adjacent to the intraosseous (IO) catheter, visualizing the IO space in long or short axis. Color flow Doppler signal will be turned on during IO use and the physician will determine if the Doppler signal is in the intraosseous space or the extraosseous space. Saved data of the ultrasound image will be reviewed independently by at least two blinded reviewers. If the conclusions from the blinded reviewers are discordant then a third blinded reviewer will evaluate the saved data.
15866600|NCT03908879|Procedure|Pressure transduction intraosseous (IO) catheter confirmation procedure|The intraosseous (IO) catheter will be attached to a pressure transducer to demonstrate a waveform on the telemetry monitor. Physicians will evaluate for the presence of a pulsatile waveform with objective measurements of a systolic pressure, diastolic pressure and mean pressure. Saved data of the waveform image will be reviewed independently by at least two blinded reviewers. If the conclusions from the blinded reviewers are discordant then a third blinded reviewer will evaluate the saved data.
15866601|NCT03908866|Other|PICC(Peripherally inserted central catheter)|The peripherally inserted central catheter with different sizes (French scale). Trained vascular access nurses will perform the insertion of the PICC, guided by ultrasound at bedside using the Seldinger technique. A suitable sterile field will be established.
15866602|NCT03908866|Other|CVC(Central venous catheter )|The central venous catheter with different sizes (French scale). Trained doctors will perform the insertion of the CVC, using the Seldinger technique. A suitable sterile field will be established.
15866766|NCT03907475|Drug|Capecitabine|Given PO
15866767|NCT03907475|Drug|Carboplatin|Given IV
15866603|NCT03908840|Biological|TBI 302|TBI 302 administered once a week in first 3 weeks and no treatment in week 4 (28 days is 1 cycle). Followed once weekly treatment of TBI 302 for 3 weeks followed by no treatment in week 4 (cycle 2)
15866604|NCT03908827|Biological|Bone Mineral Aspirate Concentrate (BMAC)|A single BMAC injection will be performed into the arthritic joint
15866605|NCT03908814|Drug|Whole Human Anti-PD-L1 Antibody Injection (LDP)|Dose escalation study evaluating six dose levels (0.1, 0.3, 1, 3 , 10and 20 mg/kg) of LDP.
15866606|NCT03908801|Behavioral|Specialized water dance intervention|Group activity in a warm pool (32-34 °C) led by two SWAN leaders. During each session, nine songs are played and the participants, assisted by a support person, perform dance movements rhythmically to the mood of the music. The songs are chosen to stimulate different movement patterns and to emphasize different emotions.
15866607|NCT03908788|Device|Intplex test|Blood sample at each tumor assessment
15866608|NCT03908775|Device|C-MAC videolaryngoscope|An intubating device that is used for nasotracheal intubation in children undergoing dental interventions. Nasotracheal intubation was applied by anesthesiologist with C-MAC videolaryngoscope.
15866609|NCT03908775|Device|Direct Laryngoscope|An intubating device that is used for nasotracheal intubation. Nasotracheal intubation was applied by anesthesiologist with direct laryngoscope.
15866610|NCT03908762|Device|iSage App with connected glucometer|Providers prescribe an insulin dosing plan to patients and provide them with a connected glucometer. The patient's plan is administered through a mobile application. In addition, patients receive education and guidance on insulin administration.
15866611|NCT03908762|Behavioral|Magnet|Patients are given a refrigerator magnet with an insulin titration algorithm and are asked to follow the instructions on the magnet.
15866612|NCT03908736|Drug|Zinc Picolinate 15 Mg|zinc picolinate, 15 mg/day for 6 months
15866613|NCT03908723|Other|Panretinal photocoagulation|Intravitreal Aflibercept with PRP to the peripheral vascular lesions
15866614|NCT03908710|Other|Treatment of hypertension using blood pressure self-measurement at home|The primary aim of the present study is to investigate whether home blood pressure recording via Bluetooth and continuous communication between doctor and patient will give improved blood pressure values when comparing the initial values with the blood pressure values recorded after 3 months. Secondary examinations include treatment of hypotension and adverse events, the patient's experience, the user's potential problems with the blood pressure cuff, app downloading, problems with history issues or problems with technical
15866615|NCT03908697|Device|Mira monitor comparison to ClearBlue monitor|Testing first morning urine with hormone test sticks at home
15866616|NCT03908684|Other|Imaging|
15866617|NCT03908671|Biological|Personalized mRNA Tumor Vaccine|subcutaneous injection with personalized mRNA tumor vaccine
15866618|NCT03908658|Other|Inspiratory muscle Training and Nasal High Flow|Inspiratory muscle Training will be used to increase respiratory muscle strength. Initial settings will depend on patient's maximal inspiratory pressure. Nasal High Flow will support respiratory muscles and thus reduce the work of breathing. By this mechanism the endurance of the respiratory muscles will increase in parallel with the strenght
15866619|NCT03908658|Device|Inspiratory muscle training and Venturi mask|Inspiratory muscle Training will be used to increase respiratory muscle strength. Initial settings will depend on patient's maximal inspiratory pressure. Venturi mask is usually applied after extubation in every day clinical practice for oxygen supplementation
15866620|NCT03908645|Device|Artificial intelligence assisted bowel preparation quality scoring system|After receiving standard bowel preparation regimen, patients go through colonoscopy under the AI monitoring device. During the withdrawal process, bowel preparation quality is monitored by AI-associated scoring system. Whenever a sub-score below 2 points is detected, endoscopist will be alarmed up to three times to wash and suck the colonic contents. Videos will be recorded and re-evaluated by experts to determine the final BBPS score. The withdrawal time is targeted at least 6min in accordance with colonoscopy quality practice. All detected polyps will be removed and obtained for histological assessment, with the possible exception of diminutive(less than 5mm) rectal polyps.
15866621|NCT03908645|Device|Conventional human scoring|After receiving standard bowel preparation regimen, patients go through conventional colonoscopy without the AI monitoring device. During the withdrawal process, after washing and sucking the colonic contents according to endoscopist's personal experience, bowel preparation quality is evaluated by human. Videos will be recorded and re-evaluated by experts to determine the final BBPS score. The withdrawal time is targeted at least 6min in accordance with colonoscopy quality practice. All detected polyps will be removed and obtained for histological assessment, with the possible exception of diminutive(less than 5mm) rectal polyps.
15866622|NCT03908619|Drug|Omeprazole 20mg|Omeprazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days
15866623|NCT03908619|Drug|Esomeprazole 20mg|Esomperazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days
15866624|NCT03908619|Drug|Rabeprazole Sodium 20mg|Rabeprazole 20mg bd/ Amoxicillin 1g bd/ Clarithromycin 500mg bd for 14 days
15866625|NCT03908619|Drug|Vonoprazan|Vonoprazan 20mg bd/ Amoxicilllin 1g bd/ Clarithromycin 500mg bd for 7 days
15866626|NCT03908606|Procedure|Scaling and root planing|Supra and subgingival scaling and root planing.
15866627|NCT03908593|Drug|Pantoprazole|Pantoprazole (40mg qd) will be concomitant used with DAPT
15866628|NCT03908580|Drug|Meditoxin|Meditoxin® (Botulinum toxin type A) was injected up to 360 U.
15866629|NCT03908567|Drug|Intranasal Drug|Intranasal administration of solution with betahistine dihydrochloride; Dosing 3 times a day
15866630|NCT03908567|Drug|Oral Tablet|Oral dosing with tablets 3 times a day
15866631|NCT03908567|Other|Intranasal Placebo|Intranasal administration of solution without betahistine dihydrochloride; Dosing 3 times a day
15866632|NCT03908554|Other|WORKPLACE HEALTH PROMOTION PROGRAM|WHPP was PMR training, posture and breath exercises, and ergonomic suggestions.
15866633|NCT03908528|Dietary Supplement|Alpha-lipoic acid Plus Chemotherapy (doxorubicin (also known as Adriamycin) plus cyclophosphamide followed by taxol)|600 mg Alpha-lipoic acid daily (an antioxidant that's in many foods, and it's made naturally in the investigator's bodies) with four cycles of doxorubicin (also known as Adriamycin) plus cyclophosphamide followed by weekly taxol for 12 weeks..
15866634|NCT03908528|Other|Placebo Plus Chemotherapy (doxorubicin (also known as Adriamycin) plus cyclophosphamide followed by taxol)|Placebo with four cycles of doxorubicin (also known as Adriamycin) plus cyclophosphamide followed by weekly taxol for 12 weeks.
15866635|NCT03908515|Device|Foldable Capsular Vitreous Body (FCVB)|FCVB can be regarded as an artificial vitreous and consists of a thin vitreous-shaped capsule, a drain tube, and a valve. After foldable implantation into the eye, then silicone oil is injected into the capsule which inflated to support the retina. The capsular material of FCVB is silicone rubber. The capsule was fabricated a computer simulation of the human and rabbit vitreous cavities. The control of the intraocular pressure is achieved with adjusting the amount of injected medium through the tube-valve system. After the medium was injected into the capsule through the tube-valve system, the valve was subsequently fixed onto the sclera surface similar to the glaucoma valve.
15866636|NCT03908489|Procedure|vital pulpotomy primary molars using garlic oil|vital pulpotomy using garlic oil
15866637|NCT03908489|Procedure|vital pulpotomy using mta|mta vital pulpotomy
15866638|NCT03908476|Device|Burst-capable SCS system|Subjects will be given Burst stimulation using a market-released Abbott SCS system. Burst stimulation may be achieved through surgical or non-surgical means.
15866639|NCT03908476|Device|DRG Stimulator|Subjects will be implanted with a market-released Abbott DRG stimulation system.
15866640|NCT03908463|Device|Percutaneous coronary intervention|All coronary intervention procedures will be performed according to current standard techniques.
15866641|NCT03908450|Device|PTCA of coronary de novo lesion PCB|PTCA of coronary de novo lesion with drug coated balloon
15866642|NCT03908450|Device|PTCA of coronary de novo lesion SCB|PTCA of coronary de novo lesion with drug coated balloon
15866643|NCT03908437|Drug|buprenorphine/naloxone|"A mobile team will be led by a nurse practitioner (able to prescribe buprenorphine/naloxone in PA) and include a peer recovery specialist (PRS), and a case manager. The team will rapidly confirm opioid use disorder and risk of overdose, complete informed consent, and begin induction procedures for a transitional (one month) course of buprenorphine/naloxone treatment. During this time, the dedicated case manager and PRS will work with the participants to help them become engaged in existing medication assisted treatment programs"
15866644|NCT03908424|Other|Epidural Blood patch.|"An epidural blood patch is a surgical procedure that uses autologous blood in order to close one or many holes in the dura mater of the spinal cord, usually as a result of a previous lumbar puncture. A small amount of the patient's blood is injected into the epidural space near the site of the original puncture; the resulting blood clot then patches the meningeal leak. An epidural needle is inserted into the epidural space at the site of the cerebrospinal fluid leak and blood is injected. The clotting factors of the blood close the hole in the dura."
15866645|NCT03908411|Procedure|Paratracheal pressure|Paratracheal pressure is applied by 30N force with the ultrasound transducer.
15866646|NCT03908411|Procedure|Sellick's maneuver|Conventional Sellick's maneuver is applied by 30N force
15866647|NCT03908372|Drug|Docetaxel|Induction CT: Docetaxel 75mg/m2 IV on d1, every 21 days for two cycles
15866648|NCT03908372|Drug|Cisplatin|Induction chemotherapy:cisplatin 75mg/m2 IV on d1,every 21 days for two cycles.Concurrent chemoradiotherapy:cisplatin 100mg/m2 IV on d1 of each 21 days for at least two cycles during 70 Gy radiotherapy
15866649|NCT03908372|Radiation|IMRT|IC+IMRT arm:the patients with complete response will receive 60Gy to the gross target volume of nasopharynx, partial response 64Gy, and the absence of response or stable will receive 70Gy. CCRT arm: 70Gy to the gross target volume of nasopharynx.
15866650|NCT03908359|Procedure|traditional cataract surgery|ACCC+ I/A + PCCC + Anti-vit: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy
15866651|NCT03908359|Procedure|minimal invasive lens surgery|We decreased the size of the capsulorhexis opening to 1.0-1.5 mm in diameter. Then we moved the location of the capsulorhexis to the peripheral area of the lens instead of the central area. A 0.9 mm phacoemulsification probe was used to remove the lens contents and/or cortical opacities.
15866652|NCT03908346|Other|Decision Aid for Surrogate Decision Makers of Comatose Survivors of Cardiac Arrest|a decision aid has been created that is a four page document meant to support surrogate decision makers for comatose survivors of cardiac arrest
15866653|NCT03908333|Drug|Ascorbic Acid|25, 37.5, 56.25 or 75 grams/m2
15866654|NCT03908333|Drug|Paclitaxel protein-bound|125mg/m2 over 30 minute IV infusions on days 1 and 8 repeated every 21 days
15866655|NCT03908333|Drug|Cisplatin|25mg/m2 in 500 mL of NS over 60minute IV infusion on days 1 and 8 repeated every 21 days
15866656|NCT03908333|Drug|Gemcitabine|1000mg/m2 in 500 mL over 30 minute IV infusion on days 1 and 8 repeated every 21 days
15866657|NCT03908320|Other|Menstrual Cycle Timing|Quit date is set to menstrual phase.
15866658|NCT03908320|Other|Menstrual Cycle Timing|Menstrual cycle timing of quit date is monitored
15866659|NCT03908320|Drug|NRT Patch|NRT patch is provided
15866660|NCT03908320|Behavioral|Cessation Counseling|Cessation counseling is provided
15866661|NCT03908307|Drug|OZURDEX|Implant 700 μg
15866662|NCT03908294|Diagnostic Test|Lab tests, non-invasive fibrosis (Fibroscan/ARFI)|Patient characteristics, lab values reflecting glucose metabolism and non-invasive fibrosis tests are documented at baseline, during therapy and up to one year after end of treatment.
15866663|NCT03908281|Behavioral|Fasted Exercise|Exercise training will take place 3 times per week and will progress to 60 minutes at a workload corresponding to 80% of Ventilatory Threshold.
15866664|NCT03908281|Behavioral|Postprandial Exercise|Exercise training will take place 3 times per week and will progress to 60 minutes at a workload corresponding to 80% of Ventilatory Threshold.
15866665|NCT03908268|Behavioral|Family Nurture Intervention (FNI)|The mother-child pair will be asked to talk and play with each other as the pair customarily does. If the child becomes restless and dysregulated, the mother will be coached by the Nurture Specialist to bring the child back into a calm state through sustained physical contact, comforting touch, soothing words and eye contact. Each dyad will attend eight group FNI sessions within sixteen weeks.
15866666|NCT03908268|Behavioral|Standard Children's Learning Center (CLC) Program|Typical, age-tailored CLC curriculum taught by CLC teachers. Children attend CLC as usual and parents do not take part in group sessions.
15866667|NCT03908255|Drug|Branch Chain Amino Acid|Nutritional supplementation
15866668|NCT03908255|Other|maltodextrin|Placebo
15866669|NCT03908242|Drug|salvianolic acid A|salvianolic acid A/Placebo 90 mg bid; salvianolic acid A/Placebo 180 mg qd
15866670|NCT03908242|Drug|Placebo|salvianolic acid A/Placebo 90 mg bid; salvianolic acid A/Placebo 180 mg qd
15866768|NCT03907475|Biological|Durvalumab|Given IV
15866673|NCT03908203|Procedure|Minimally invasive one-level lumbar deformity correction|The study treatment represents modified technique of MIS TLIF: one level screws fixation using Wiltse approach at one side, the other side - percutaneously, one level decompression, correction of segmental deformity by performing vertebrotomy and then intervertebral fusion.
15866674|NCT03908190|Behavioral|Personalized Support for Progress|Participants will receive the Personalized Support for Progress Intervention from a peer support provider including sessions with the peer support provider to complete a prioritization task, develop a personalized care plan, and receive support for implementing the personalized care plan.
15866675|NCT03908177|Device|Ceramic Dental Implant|The ceramic implant will be placed in healed extraction sockets in the premolar-to-premolar area in the mandible and maxilla for single tooth replacement followed by prosthetic loading after 4 months healing time. Type 4 surgery will be performed as defined by the ITI Consensus Statements for Implant Placement in Extraction Sockets: healed sites, typically around 16 weeks after tooth was extracted or after tooth was lost to allow complete healing of the ridge as well as soft- and hard tissue maturation. Both SG and CG receive routine treatment, only the choice of the implant material is defined by the study protocol.
15866676|NCT03908177|Device|Titanium Dental Implant|The titanium implant will be placed in healed extraction sockets in the premolar-to-premolar area in the mandible and maxilla for single tooth replacement followed by prosthetic loading after 4 months healing time. Type 4 surgery will be performed as defined by the ITI Consensus Statements for Implant Placement in Extraction Sockets: healed sites, typically around 16 weeks after tooth was extracted or after tooth was lost to allow complete healing of the ridge as well as soft- and hard tissue maturation. Both SG and CG receive routine treatment, only the choice of the implant material is defined by the study protocol.
15866677|NCT03908164|Biological|Pertussis containing vaccine|Participants will receive a pertussis containing vaccine licensed for use in pregnancy at one of three time periods.
15866678|NCT03908151|Device|CMK21 Hip system|Total hip arthroplasty
15866679|NCT03908138|Drug|RDD|Lenalidomide: 25mg, po, d1-21， Pegylated Liposomal Doxorubicin: 30-40mg/m2，ivgtt, d1 Dexamethasone: 20-40mg, po, d1，d8，d15，d22
15866680|NCT03908138|Drug|VDD|Bortezomib:1.3mg/m2，ih，d1，d4，d8，d11 Pegylated Liposomal Doxorubicin: 30-40mg/m2，ivgtt, d1 Dexamethasone: 20 mg, ivgtt, d1, 2, 4, 5, 8, 9, 11,12
15866681|NCT03908125|Device|Eversense® CGM system|Continuous Glucose monitoring device that lasts up to 90 days
15866682|NCT03908112|Behavioral|Standard Community Concussion Care (SC)|temporary rest, gradual increase in activity, and return to school and sports. In some cases vestibular an balance therapy are necessary, aerobic exercises, medication, counseling.
15866683|NCT03908112|Behavioral|SC plus Simple Convergence Exercises (SC+)|In addition to standard community care in this intervention the participants must perform convergence therapy every day at home
15866684|NCT03908112|Behavioral|SC plus Office-based Vergence/Accommodative Therapy (SC+OBVAT)|In addition to standard community care in this intervention the participants must come to the office once a week for a 1-hour therapy session with a therapist. Office-based vergence/accommodative therapy is performed for 12 weeks with home reinforcement.
15866685|NCT03908099|Behavioral|Fit-For-Fertility program|The Fit-for-Fertility Program aims at implementing progressive and sustainable lifestyle changes. Participants will attend individual sessions with a dietitian and a kinesiologist every 6 weeks for the first 6 months, then every 8 weeks for the 6 following months, and then every 12 weeks until end of the study. Follow-up by telephone/e-mail will be offered between in-person meetings. These professionals will be trained in motivational counselling skills. Participants will also benefit from weekly group sessions divided into 2 parts: 1) Workshops covering 8 different topics (45 minutes) addressing healthy lifestyle and 2) Supervised classes of physical activity where one of 8 different types of exercise (45 minutes) will be practiced. Women will be required to attend all 8 different sessions within the first 6 months. Pregnant women will be met to set new lifestyle objectives specific to pregnancy, including optimal gestational weight gain based on the Institute of Medicine guidelines.
15866686|NCT03908099|Other|Standard of care|The control intervention will consist of immediate initiation of usual fertility care, as recommended by each fertility specialist, for a maximum of 24 months. The experimental intervention will be the Fit-for-Fertility Program alone for the first 6 months, then in combination with usual fertility care for an additional 12 months and thereafter, usual fertility care can continue to be provided alone for a maximum follow-up of 24 months. The lifestyle program is provided for a maximum of 18 months if there is no pregnancy, or otherwise, up to the end of pregnancy or to a total study follow-up of 24 months (whichever comes first).
15866687|NCT03908086|Other|Risk factors in RA cohort|
15866688|NCT03908086|Other|Risk factors in general population|
15866689|NCT03908073|Device|Transcutaneous vagal nerve stimulation|The use of a transcutaneous vagal nerve stimulator by the participant
15866690|NCT03908060|Drug|Methadone|One intravenous administration of methadone (0.2 mg/kg ideal body weight)
15866691|NCT03908060|Drug|Morphine|One intravenous administration of morphine (0.2 mg/kg ideal body weight)
15866692|NCT03908047|Other|magnetic resonance imaging|functional magnetic resonance imaging and diffusion tensor imaging after tibialis nerve stimulation
15866693|NCT03908034|Other|presence of uncontrollable risk factor|the presence of an uncontrollable / unremovable risk factor for a disease
15866694|NCT03908034|Other|induction of anticipated regret|higher level of elaboration on potential regret
15866695|NCT03908021|Diagnostic Test|Microbiome analysis and 16S rRNA gene-based analysis|microbial DNA is extracted from the saliva and 16s library is prepared for sequencing.
15866696|NCT03908008|Drug|Botox (Botulinum toxin type A)|20U of the investigational drug will be intramuscularly injected to 5 sites of the glabella line. Treatment will be conducted just once in visit 2.
15866697|NCT03908008|Drug|MT10107 (Botulinum toxin type A)|20U of the investigational drug will be intramuscularly injected to 5 sites of the glabella line. Treatment will be conducted just once in visit 2.
15866698|NCT03907995|Behavioral|Cognitive Behavioral Therapy|The form of treatment will involve 6 group sessions every two weeks about an hour each. Sessions consist of teaching a different coping technique in each session to help cope with disaster or other events.
15866699|NCT03907982|Procedure|DC Cardioversion|DC cardioversion (DCCV) is used to treat irregular heart rhythms (commonly atrial fibrillation). The procedure involves sedation or anaesthetic and placement of electrodes on the chest. An electrical impulse is passed across the electrodes to return the heart rhythm to normal.
15866700|NCT03907982|Procedure|Pulmonary vein isolation|The cryoballoon (CE marked) is the key specified technique for performing pulmonary vein isolation in the ablation arm in this trial. This allows the physician electrophysiologist to perform a circumferential freeze around the pulmonary veins to electrically isolate the vein, thus preventing pulmonary vein ectopy from triggering AF.
15866701|NCT03907982|Device|Implantable loop recorder|The Reveal device is inserted in the pre-pectoral position under the skin. This is performed with local anaesthetic and sedation at the end of the procedure clinic by the electrophysiologist performing the procedure. The device will provide a continuous recording of the heart rhythm and rate, and will be able to down load duration of AF episodes via a home monitoring system to establish the primary endpoint of the study.
15866704|NCT03907956|Other|Dry Needling with Fascial Winding Technique|"For placement of Dry Needling (DN) needles with Fascial Winding Technique (FWT) according to the Four-pole Carpal Dry Needling (FCDN) approach model, only anatomical references are used, in all cases from a carpal ventral approach. The needles used are the Chinese type with silver handle and guide tube, measuring 25x0.30 mm., Agupunt® brand. Four needles are placed, at the level of the bones: scaphoid, pisiform, trapezius and hamate. The four needles follow an oblique direction, always on the back and looking for the midline of the center of the carpal tunnel, with an inclination of approximately 45º, both in the cranio-caudal and medial-lateral directions. In each of the needles, it deepens until it reaches a firm elastic stop, attributable to the Transverse Carpal Ligament. Next, the FWT is applied to each of the needles, consisting of rotating them in the same direction until you feel the final stop of the needle grasp."
15866705|NCT03907943|Procedure|carotid endarterectomy|Surgical treatment of ICA stenosis.
15866706|NCT03907930|Procedure|percutaneous nephrolithotripsy|removal of kidney and upper ureteric stones through small incision in the loin using nephroscope after disintegration by lithoclast
15866707|NCT03907917|Device|tDCS|Subjects will receive 20 minutes of multifocal transcranial direct current stimulation. The anode will be placed over the frontal pole (Fpz, 10-20 EEG) and will be surrounded by 5 return electrodes (cathodes). Current will be set at 1.5mA and will be ramped in/out at the begging and end of the 20-minutes of stimulation over the course of 30 seconds.
15866708|NCT03907904|Device|CPOM Optical Neuromonitor|Prior to induction of anesthesia, the CPOM monitor will be secured to the temporal region of the participant's forehead to measure and record the cerebral hemodynamic data before, during, and following intubation. Hemodynamic, respiratory, body temperature, and anesthetic data will be continuously digitally records. The CPOM device will be detached after extubation in the operative room.
15866709|NCT03907891|Behavioral|Motivational social support from nurse|A 60-minute motivational interviewing session with a nurse, followed by 6 weeks of daily motivational social support text messages.
15866710|NCT03907891|Behavioral|Motivational social support from nurse with additional support from significant other|A 60-minute motivational interviewing session with a nurse, followed by 6 weeks of daily motivational social support text messages from both a nurse and the patient's self-identified significant other.
15866711|NCT03907891|Behavioral|Attention control|A 60-minute session with a nurse focused on American Heart Association educational videos and written information.
15866712|NCT03907878|Biological|Ligelizumab|Liquid in vial
15866713|NCT03907865|Drug|Softacort|Group 1: 4 times daily for the first 12 days of the treatment period and then 2 times daily for 2 additional days Group 2: 3 times daily for the first 8 days of the treatment period and then 2 times daily for 3 additional days
15866714|NCT03907852|Drug|gavo-cel|gavo-cel
15866715|NCT03907852|Drug|fludarabine|fludarabine
15866716|NCT03907852|Drug|cyclophosphamide|cyclophosphamide
15866717|NCT03907852|Biological|anti-PD1|anti-PD1
15866718|NCT03907839|Other|clinical trials|examined two type of training on cognitive parameters for COPD patients
15866719|NCT03907826|Drug|PD-1 blocking antibody|Toripalimab is an antibody targeting PD-1 developed by Shanghai Junshi Biosciences Co., Ltd.
15866720|NCT03907826|Radiation|IMRT|IMRT 60-66Gy, 1.8-2.0Gy/f/day
15866721|NCT03907813|Drug|Exparel|liposomal bupivacaine wound infiltration
15866722|NCT03907813|Other|Saline infiltration|saline wound infiltration
15866723|NCT03907800|Drug|Nab-paclitaxel|125 mg/m² weekly, infusion, 3 weeks on 1 week off, applicated for four cycles.
15866724|NCT03907800|Drug|Carboplatin|AUC 2, weekly, 3 weeks on 1 week off, applicated for 4 cycles
15866725|NCT03907800|Drug|Herceptin|In case of HER2-positive, patients receive Herceptin weekly during all cycles.
15866726|NCT03907787|Dietary Supplement|Zingiber officinale and Acmella oleracea|Subjects were supplied for four weeks with two tablets/day and there was the evaluation of pain intensity, by a 30-days Visual Analogue Scale (VAS) and b) the assessment of knee function by Western Ontario and McMaster Universities Arthritis Index and by Tegner Lysholm Knee Scoring collected at baseline, at 15 and 30 days after treatment, Health-related quality of life, by the ShortForm36, inflammation by C-reactive protein and Erythrocyte Sedimentation Rate, body composition by dual-energy X-ray absorptiometry measured at baseline and 30 days after treatment.
15866727|NCT03907761|Procedure|Hydrodissection|high velocity stream of normal saline is given to the dissection area by help of 10 ml syringe
15866728|NCT03907748|Other|Music Intervention|After training, caregivers will deliver the music intervention to the person with dementia whom they care for. The music intervention will include: a) singing familiar/preferred music followed by discussions facilitated by the caregiver about any associated meanings or memories; b) movement to music (e.g. upper body and arms imitating familiar dance movements to music); c) instrument playing; and d) listening to familiar/preferred relaxing or enlivening music (dependent upon symptoms present in the moment). These methods are known to assist in emotion regulation and increase cognitive reserve (e.g. attention and perceptual-motor function).
15866769|NCT03907475|Drug|Gemcitabine Hydrochloride|Given IV
15866770|NCT03907475|Drug|Nab-paclitaxel|Given IV
15866771|NCT03907475|Drug|Paclitaxel|Given IV
15866772|NCT03907475|Drug|Pegylated Liposomal Doxorubicin Hydrochloride|Given IV
15867000|NCT03905681|Device|Transcutaneous Electrical Nerve Stimulation|Application of TENS pads and wearing of the TENS device.
15868288|NCT03895489|Device|Zimmer|Zimmer Persona® The Personalized Knee prosthesis
15866729|NCT03907748|Other|Reading Intervention|After training, caregivers will deliver the reading intervention to the person with dementia whom they care for. The reading intervention will include: a) the caregiver reading aloud to the person they are caring for; b) the person with dementia reading aloud to their caregiver; and c) discussion of the text and personal responses. Strategies to engage the person with dementia and to create opportunities for meaningful dialogue will be provided, as well as guidance on selecting reading material that is accessible to the person's level of cognitive impairment.
15866730|NCT03907735|Other|Myometrial tissue sample collection|Myometrial tissue samples by core needle biopsy under ultrasound guidance
15866731|NCT03907722|Other|Long pentraxin 3|Primary PCI
15866732|NCT03907709|Behavioral|In-Home Addiction Treatment Program|"Treatment was delivered per treatment protocol
~Primary IHAT Care Team consisted of a licensed Care Coordinator (LPN, RN, MSW, LPC, or LMFT) and two Recovery Advisors
~Urine drug screens administered randomly
~Appointments were scheduled per protocol for 52 weeks
~Within first two weeks of care, all clients are provided an evaluation by a psychiatrist to ensure fitness for program"
15866733|NCT03907696|Other|Anti-stigma interventions curriculum|educational curriculum aimed at reducing stigma
15866734|NCT03907683|Behavioral|Short Message with Text and Optional Image|"Messages can be up to 256 characters of text and with or without an image. Move more and sit less messages were written to target established cognitive and affective constructs associated with physical activity (e.g., prompts to action plan, guidance for maximizing pleasure by regulating intensity)."
15866735|NCT03907657|Drug|Perflutren lipid microsphere|Baseline B-mode US will be performed to confirm the lesions being imaged (unless it is a subject with no lesions, then a basic B-mode US will be performed. Perflutren is a diagnostic drug that is intended to be used for contrast enhancement. The vial contains a clear, colorless, sterile, non-pyrogenic, hypertonic solution which is activated by mechanical agitation with Vialmix®.It will be dispensed in inactivated form to a study team member. The contrast agent will be activated just prior to administration (ideally to be used within 5 minutes of activation). Contrast agent Definity (or Lumason) will be activated according to package insert instructions, including use of VialMix®, the device used to activate Definity. Administration will occur IV in coordination with sonography staff trained specifically in contrast ultrasound imaging.The total imaging time is anticipated to be less than 30 minutes.
15866736|NCT03907657|Drug|Sulfur hexafluoride lipid microspheres|Baseline B-mode US will be performed to confirm the lesions being imaged (unless it is a subject with no lesions, then a basic B-mode US will be performed. Lumason will be used as a secondary contrast agent only if Definity(perflutren) is unavailable.This drug will be administered using the dosing range and administration type within the Lumason prescribing information. The contrast agent will be activated just prior to administration (ideally to be used within 5 minutes of activation). Contrast agent Definity (or Lumason) will be activated according to package insert instructions, including use of VialMix®, the device used to activate Definity. Administration will occur IV in coordination with sonography staff trained specifically in contrast ultrasound imaging.The total imaging time is anticipated to be less than 30 minutes.
15866737|NCT03907644|Device|Transcranial Alternating Current Stimulation (tACS)|The tACS stimulator delivers very low (2mAmp) current with surface electrodes to the skull.
15866738|NCT03907631|Other|Standard of care|care decisions driven by local physicians; this is an observational cohort
15866739|NCT03907618|Diagnostic Test|ovarian reserve|To assess ovarian reserve in patients with Type 1 Diabetes Mellitus aged 18-40 years; ultrasonographic and laboratory parameters will be looked at.
15866740|NCT03907605|Other|anti- mullerian hormone|All patients belong to the same group. The blood samples will be collected at the time of surgery and 3 months after surgery from the patients who need uterine artery ligation for PPH. The blood samples will be centrifuged within 2 hours after being obtained and assessed on the same day. AMH concentrations will be measured with an enzymatically amplified two-sided immunoassay
15866741|NCT03907592|Dietary Supplement|L-carnitine supplementation|Supplementation of 1000 mg L-carnitine-L-tartrate in combination with 3000 mg L-leucine per day throughout the study period.
15866742|NCT03907592|Dietary Supplement|Leucine supplementation|Supplementation of 4000 mg L-leucine per day throughout the study period.
15866743|NCT03907592|Procedure|Resistance training|Resistance training at the gym, twice a week for 24 weeks (48 training units in total).
15866744|NCT03907579|Behavioral|Inflatable colon educational module|Participants attend a brief educational presentation in an inflatable colon, learning about colorectal cancer prevention and screening.
15866745|NCT03907566|Other|The Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals|Swallowing function will be evaluated by the Turkish Oropharyngeal Dysphagia Screening Test for Patients and Professionals
15866746|NCT03907553|Diagnostic Test|targeted genome sequencing|
15866750|NCT03907527|Biological|PRGN-3005 UltraCAR-T cells|Given IP
15866751|NCT03907527|Biological|PRGN-3005 UltraCAR-T cells|Given IV
15866752|NCT03907514|Behavioral|"FALE Application"|"FALE is a digital tool, in the form of an application for smartphones, which aims to demonstrate empathy and facilitate communication between the adolescent patient and the dentist. The application contains 14 questions regarding dental anxiety, feelings and patient coping preferences regarding dental care."
15866753|NCT03907501|Dietary Supplement|Synbiotic|an herbal prebiotic plus probiotic
15866754|NCT03907501|Dietary Supplement|Probiotic|Triphala alone
15866755|NCT03907501|Dietary Supplement|Placebo|Inert capsule
15866773|NCT03907462|Behavioral|SMART 2.0|SMART 2.0 uses a fully integrated system of modalities that includes: 1) a popular consumer-level wearable, wireless scale, and corresponding app; 2) a highly tailored and interactive text messaging system; 3) multiple social media streams; 4) social network mechanisms of influence; and 5) technology-mediated health coaching.
15866774|NCT03907449|Diagnostic Test|Preview Rapid Strep A test|Rapid assay for the detection of type A streptococcal infection of the throat.
15866775|NCT03907436|Other|USDA Diet|Participants will receive counseling and education on USDA Guidelines for Americans, 2010
15866776|NCT03907436|Other|Mediterranean Diet|Participants will receive counseling and education on a Mediterranean diet.
15866777|NCT03907423|Drug|Rosuvastatin10 mg tablet|Diabetic patients treated with Rosuvastatin 10mg/day plus Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral
15866778|NCT03907423|Drug|Placebo Oral Tablet|Diabetic patients treated with Glimepiride 1-8mg/day and Metformin 500-2550 mg/day oral
15866779|NCT03907410|Other|Nominal Financial Incentives|The nominal financial incentives will consist of fixed-ratio incentives for each inhaled corticosteroids (ICS) actuation (25 cents for children on 4 daily ICS doses and 50 cents for children on 2 daily doses), with a maximum of $1 per day.
15866780|NCT03907410|Other|Daily Adherence Reminders/Adherence Performance Feedback|Study participants will receive automated daily text message or push notification reminders and automated weekly feedback summarizing their adherence performance through Way to Health, a mobile health, electronic monitoring platform.
15866781|NCT03907397|Biological|Peanut Protein|up to 9043 mg
15866782|NCT03907384|Behavioral|Mat Pilates training|This group completed 12-weeks of training
15866783|NCT03907371|Drug|Donepezil Hydrochloride|Donepezil will be used with a dosage of 5 milligram at 8 am for one week (Week 1), then 10 milligram at 8 am for 23 weeks (Week 2-24).
15866784|NCT03907371|Other|Placebo|Placebo will be used with a dosage of one half pill at 8 am for one week (Week 1), then one pill at 8 am for 23 weeks (Week 2-24).
15866785|NCT03907358|Procedure|phacoemulsification|
15866786|NCT03907345|Behavioral|Exposure|The exposure session comprises a hierarchy of 7 steps, reaching from (1) holding a glass with the spider 30cm in from the body / face, to (7) letting the spider walk on the arm. The exposure session has a duration of 120 minutes. Prior to the exposure, participants receive psychoeducation on anxiety and phobias. A house spider (Tegenaria domestica) is used for the exposure.
15866787|NCT03907332|Other|Home visits|An experimental design, a cluster randomized controlled trial (RCT) will be used. A total of 20 clusters will be randomized with block randomization of electoral areas with a) resident staff midwives and b) resident Community Health Nurse midwifes. All women residing in an electoral area will receive the same intervention for practicality and to prevent contamination.
15866788|NCT03907319|Device|SIS System|Software technology for visualization of anatomical structures in the brain
15866789|NCT03907306|Procedure|Wound healing|The measurement of a wound area is committed on the 2nd, 8th, 14th, 21nd and 30th day after operation. By means of the mathematical formulas the wound healing speed will be defined. The wound process will be researched with the help of cytological method. The wound prints will be taken on the 2nd, 8th, 14th, 21nd and 30th day after operation. Microbiological research of a wound will be held on the 2nd, 8th, 14th, 21nd and 30th day after operation (in study groups before and after the usage of CAP, in control groups once). The pain assessment will be measured by a visual analogue scale on the 2nd, 3rd,4th, 5th, 6th, 7th, 8th, 14th, 21nd and 30th day after operation. The life quality will be researched by means of Health Status Survey on the 8th and 30th day before operation.
15866790|NCT03907293|Behavioral|Exercise-based cardiac rehabilitation|Moderate intensity aerobic exercise, lifestyle advice, and psychological support.
15866791|NCT03907280|Drug|BI 1265162 (T1)|oral solution
15866792|NCT03907280|Drug|BI 1265162 (T2)|Solution for inhalation
15866793|NCT03907280|Drug|BI 1265162 (R)|concentrate for i.v. solution
15866794|NCT03907280|Drug|BI 1265162 (T3)|Solution for inhalation
15866795|NCT03907267|Drug|Taurine Solution|Taurine Solution
15866796|NCT03907267|Dietary Supplement|Normal Saline|Normal Saline
15866797|NCT03907254|Other|Service Dog Training Program|Participants will spend one hour, two times a week working with professional service dog trainers in order to shape the dog's behavior for it's future role as a service dog for service members with mobility impairments.
15866798|NCT03907241|Drug|Octanorm 16.5%|Human normal immunoglobulin
15866799|NCT03907228|Dietary Supplement|RHT-3201|PROBIOTIC
15866800|NCT03907215|Drug|ACT541468|50 mg; film-coated tablet for oral use
15866801|NCT03907215|Drug|ACT541468 placebo|film-coated tablet for oral use
15866802|NCT03907215|Drug|Citalopram|20 mg; tablet tor oral use; for single- or repeated dosing
15866803|NCT03907202|Drug|Daily injection of KBP/placebo for up to 28 days|Daily sub-cutaneous injection of KBP-089/Placebo into a lifted skin fold of the abdominal wall.The injection will be administered in the morning before breakfast.
15866804|NCT03907176|Drug|HTX-011|300 mg
15866805|NCT03907176|Device|Luer lock applicator|Applicator for instillation
15866806|NCT03907176|Drug|Ibuprofen|600 mg
15866807|NCT03907176|Drug|Acetaminophen|1 g
15866808|NCT03907163|Drug|Dronabinol|Capsules containing 5 mg Dronabinol
15866809|NCT03907163|Other|Placebo|capsules identical in appearance to dronabinol
15866810|NCT03907150|Diagnostic Test|Strain ultrasound|Post-interpretation of recorded ultrasound loops
15866811|NCT03907124|Drug|Genetically-guided treatment with FDA-approved psychotropic drugs|Psychiatric patients in this experimental arm will receive genetically-guided treatment with psychotropic medications
15866812|NCT03907124|Drug|Treatment as usual (TAU)|All subjects assigned to TAU group, which is the control arm, will continue to receive FDA-approved psychotropic medications for psychiatric indications investigated in this study
15866813|NCT03907111|Device|Chitosan Gauze|Gauze made by chitosan material
15866814|NCT03907111|Device|placebo|traditional gauze
15866815|NCT03907098|Drug|Endostar|an anti-angiogenesis drug
15866816|NCT03907098|Drug|Chemotherapy|Physician's choice
15866962|NCT03905954|Other|Usual care|For this cross sectional survey, participants will be receiving usual care according to there health care systems
15867223|NCT03904004|Procedure|Botulinum toxin injection|Injection of botulinic toxin to inhibit the contraction of the gastro-oesophageal junction muscular layer
15866817|NCT03907085|Other|HILT + exercise|High intensity laser therapy-Patients received pulsed laser treatment, using a HIRO 3 device (ASA Laser, Arcugnano, Italy), five times a week for a period of three weeks, and one session per day for a total of 15 sessions. A 3-phase treatment program was performed in each session, and the patients were then given a daily exercise program once a day by a physiotherapist. Exercise program; A physiotherapist-assisted exercise program was performed by the two groups, five times a week for three weeks, for approximately 25 minutes. The exercise programs consisted of stretching exercises to the plantar fascia and Achilles tendon, active range of motion (ROM) exercises, and strengthening exercises to the tibialis posterior and peroneus muscles. The patients were also taught to collect the foot and towel.
15866818|NCT03907085|Other|Placebo HILT + exercise|Placebo HILT group; Placebo therapy was applied in five sessions a week for three weeks, with a total of 15 sessions a day, with no current flowing through the device. This was followed by the exercise programs described above, performed once a day with the physiotherapist. Exercise program; A physiotherapist-assisted exercise program was performed by the two groups, five times a week for three weeks, for approximately 25 minutes. The exercise programs consisted of stretching exercises to the plantar fascia and Achilles tendon, active range of motion (ROM) exercises, and strengthening exercises to the tibialis posterior and peroneus muscles. The patients were also taught to collect the foot and towel.
15866819|NCT03907072|Drug|WVE-210201 (suvodirsen)|WVE-210201 is a stereopure antisense oligonucleotide (ASO)
15866820|NCT03907072|Drug|Placebo|Buffered saline solution
15866821|NCT03907059|Dietary Supplement|whey protein|supplementation individually adjusted to 1.6g/kg/day
15866822|NCT03907059|Dietary Supplement|soy protein|supplementation individually adjusted to 1.6g/kg/day
15866825|NCT03907033|Drug|Liposomal bupivacaine|Liposomal bupivacaine is a novel formulation of local bupivacaine and allows prolonged release of the medication, thereby providing longer lasting effects. It is approved by the FDA and has been shown to provide excellent pain control after surgery.
15866826|NCT03907033|Drug|Bupivacaine Hydrochloride|We currently administer local plain bupivacaine during vaginal hysterectomy to decrease pain in the postoperative period. Bupivacaine is an anesthetic that works by blocking nerve conduction and producing a numbing effect.
15866827|NCT03907020|Dietary Supplement|Barley|Assessing the metabolic availability of lysine in barley.
15866828|NCT03907007|Device|Percutaneous electrical nerve stimulation|Stimulation and medication at the same instant
15866829|NCT03907007|Device|Percutaneous electrical nerve stimulation|Stimulation is given without administering medication
15866830|NCT03906994|Other|Video game Mario Kart Wii|Subjects will place a patch over the better-seeing eye and play the video game Mario Kart Wii for a total of 40 hours over a 1 month perior
15866831|NCT03906981|Other|Plaque from each subject will be collected but there will be no intervention|No intervention
15866832|NCT03906968|Device|SinuSonic Device|A medical device that utilizes sound and pressure combined with normal breathing to relieve nasal congestion
15866833|NCT03906955|Behavioral|Efficacy for Lifestyle PA|The intervention group is asked to participate in three (10-minute) video chats during the first three weeks of six weeks of engaging in lifestyle physical activity. Participants in this group will receive information that addresses outcome expectations in week one (e.g. physical, social, and self-evaluative outcomes and intrinsic and extrinsic motives), self-efficacy in week two (e.g. the four efficacy sources: vicarious experiences, mastery experiences, social persuasion, and perceptions of physiological and affective responses to behavior), and self-regulatory strategies in week three (e.g. goal-setting, self-monitoring, and planning) for engaging in lifestyle physical activity.
15866834|NCT03906955|Behavioral|Efficacy for Work-life Balance|The time-matched control group is asked to participate in three (10-minute) video chats during the first three weeks of six weeks of engaging in lifestyle physical activity. Participants in this group will receive information that addresses outcome expectations in week one (e.g. physical, social, and self-evaluative outcomes and intrinsic and extrinsic motives), self-efficacy in week two (e.g. the four efficacy sources: vicarious experiences, mastery experiences, social persuasion, and perceptions of physiological and affective responses to behavior), and self-regulatory strategies in week three (e.g. goal-setting, self-monitoring, and planning) for work-life balance.
15866835|NCT03906942|Behavioral|Fun For Wellness (FFW)|FFW consists of videos, games, and content in the form of 152 BET I CAN challenges [1]. Behavior challenges are intended to increase a participant's capabilities to set a goal and to create positive habits. Emotion challenges are intended to increase a participant's capabilities to cope with negative emotions and to cultivate positive emotions. Thought challenges are intended to increase a participant's capabilities to challenge negative assumptions and to create a new narrative for their life. Interaction challenges are intended to increase a participant's capabilities to communicate and connect with others. Context challenges are intended to increase a participant's capabilities to read cues and to change cues in the environment. Awareness challenges are intended to increase a participant's capabilities to know herself/himself and to know the issue. Next steps challenges are intended to increase a participant's capabilities to make a plan and to stick with a plan.
15866836|NCT03906929|Device|buried intramedullary K-wire|Using of buried kirschner wire in pediatric forearm fixation
15866837|NCT03906929|Device|exposed intramedullary K-wire|Using of exposed kirschner wire in pediatric forearm fixation
15866838|NCT03906916|Diagnostic Test|1,3-β-D-glucan quantification|Patients hospitalised in Internal Medicine with suspicion of invasive candidiasis will be evaluated by 1,3-β-D-glucan test and by means of blood culture to confirm the diagnosis
15866839|NCT03906916|Drug|Micafungin|Patients hospitalised in Internal Medicine with suspicion of invasive candidiasis will be treated with an echinocandin (micafungin) as timely as possible, and they will continue the antifungal treatment according to international guidelines when diagnosis is confirmed by positive 1,3-β-D-glucan test.
15866840|NCT03906903|Device|Repetitive Transcranial Magnetic Stimulation|Subjects will receive both active and placebo rTMS, in a crossover modality.
15866841|NCT03906903|Behavioral|Cognitive Stimulation|Subjects will receive 30 sessions of 30 minutes with Cognitive Stimulation in three areas (attention, memory and executive functions), one each week.
15866842|NCT03906877|Procedure|Acid hyaluronic injection laryngoplasty|Hyaluronic acid is injected into the paralyzed vocal fold
15866843|NCT03906877|Behavioral|Voice therapy|"15 sessions of thirty minutes of voice therapy, twice a week, and home practice.
~This voice management will be specific to unilateral vocal fold paralysis and will focus on three objectives: reinforcement of the vocal muscle, glottal closure and glottal opening. These three objectives will be worked through different vocal exercises (on voiced phonemes) and breathing exercises"
15866844|NCT03906877|Other|Sham of injection|Injection of physiological saline under the skin of the neck (sham of injection).
15866845|NCT03906877|Other|Sham of voice therapy|"15 sessions of thirty minutes of voice therapy, twice a week, and home practice.
~This voice management will not be specific to UVFP but may allow patients to improve their vocal gesture."
15866846|NCT03906864|Other|Care Pathway|"The intervention group had the following as part of the integrated care pathway:
~Medical assessment on admission for risk factors for falls.
~A weekly assessment of complications including pain, deep venous thrombosis, anaemia, wounds and pressure ulcers, etc. The Confusion Assessment Method and the Geriatric Depression Scale were utilized.
~Physiotherapy and occupational therapy guidelines with recommended milestones (set for the full, partial and non-weight bearing groups)
~Physiotherapy Clinical Outcome Variables Scale (PTCOVS)16 was used by the physiotherapists in the intervention group to assess the baseline mobility, to define outcome goals and to direct treatment plans.
~A postoperative hip precaution handout (containing information on avoiding hip prosthesis dislocation in patients with total hip replacement or hemiarthroplasty) was given to patients and their caregivers."
15866847|NCT03906851|Behavioral|Activity and diet|Physical activity: use of physical activity in theoretical subjects (3 x 30 min/week), physically active breaks (5 x 5 min/week), physical education (2 x 45 min/week) Nutrition: focus on school meals
15866848|NCT03906838|Drug|Ropivacaine injection|Regional Anesthesia Nerve Block: Incremental injections up to total of 20 mL of 0.5% ropivacaine is administered.
15866849|NCT03906825|Dietary Supplement|CEAG|Curcuminoids, EPA (OMEGA-3), Astaxanthin, GLA
15866850|NCT03906825|Dietary Supplement|placebo|placebo
15866851|NCT03906812|Other|Telemetry|Bed type assignment
15866852|NCT03906812|Other|Unmonitored|Bed type assignment
15866853|NCT03906799|Drug|OMT-28|1 capsule given daily orally from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days).
15866854|NCT03906799|Drug|Placebo|1 capsule given daily orally from Visit 3 (Day 1) to Visit 8 (Day 99 ± 3 days).
15866855|NCT03906786|Behavioral|motivational interviewing|The intervention will consist of 4 structured medical consultations in the form of a motivational interviewing compared to usual care, covering a 12-month intervention period. In both groups, the frequency of visits (c / 3 months) and the variables collected will be the same.
15866856|NCT03906773|Other|Patient Centered Medical Home Based Electronic Framework for Advance Care Planning|The intervention tested a pre-visit ACP workflow centered around a framework sent via secure Electronic Health Record (EHR)-linked patient portal in a real world clinical setting. The primary objectives were to determine its impact on frequency and quality of ACP documentation.
15866857|NCT03906760|Other|Magnetic resonance imaging (MRI)|MRI protocol associating sagittal and axial (+/- coronal) sequences in T2 + / - turbo spin T1 weighting with fat saturation.
15866858|NCT03906747|Other|Interviews, questionnaire and focused group discussions|"To determine the effectiveness of the quality of care as perceived by relatives, we will perform a survey during the ED stay, with the next-of-kin to patients who was on the EOL pathway using a questionnaire developed for ED settings. The questionnaire will be administered by the research assistant face-to-face in the emergency department to assess the quality of care and the level of support provided to patients and their families in the last days of life.
~We will also determine the level of staff's knowledge and perception of the EOL care using a locally-designed self-administered anonymous survey.
~A focus group discussion (FGD) will be formed in each hospital to identify the gaps to the current EOL care by structured questionnaire. The group will also make recommendations to improve the quality of the EOL care. There will be separate FGD for: (i) healthcare professionals (ii) family members and (iii) general practitioners who will care for the patient if terminally discharged."
15866859|NCT03906747|Other|Review of medical records|"Electronic medical records will be reviewed to collect the following data:
~Proportion of patients who fits criteria of EOL who died within 48 hours;
~Proportion of patients on EOL pathway who have documentation that patient and/or family are given opportunities to discuss an individualised care plan;
~Proportion of patients on EOL pathway who have documentation of an individualised care plan that is followed;
~Proportion of patients on EOL pathway who have symptoms who are prescribed with medicines with individualised indications for use, dosage and route of administration"
15866860|NCT03906734|Procedure|Septal myectomy|Transaortic septal myectomy
15866861|NCT03906734|Procedure|alfieri stich|Transaortic Mitral valve repair using alfieri technique
15866862|NCT03906734|Procedure|Subvalvular intervention|Transaortic Mitral valve subvalvular intervention including anterior mitral leaflet secondary cord cutting, papillary muscle release
15866863|NCT03906721|Drug|Placebo|Sugar pill used to condition patients.
15866864|NCT03906721|Drug|Oxycodone|An opioid used for analgesia.
15866865|NCT03906721|Other|Essential Oil|An aromatic oil used for conditioning.
15866866|NCT03906708|Other|Diffusion Capacity of the Lung for Carbon Monoxide (DLCO)|Infant lung function testing
15866867|NCT03906695|Drug|ASTX727|oral decitabine 5mg + cedazuridine
15866868|NCT03906695|Drug|ASTX727|oral decitabine 5mg + cedazuridine
15866869|NCT03906695|Drug|ASTX727|oral decitabine 10mg + cedazuridine
15866870|NCT03906695|Drug|ASTX727|oral decitabine 20mg + cedazuridine
15866871|NCT03906695|Drug|ASTX727|oral decitabine 10mg + cedazuridine
15866872|NCT03906682|Behavioral|RAP Club|RAP Club was adapted from a trauma treatment program called Structured Psychotherapy for Adolescents Responding to Chronic Stress (SPARCS). Core program components include psychoeducation, mindfulness, and cognitive-behavioral strategies.
15866963|NCT03905941|Drug|Metformin|Metformin 2000 mg/day will be used in this study. Metformin is a antihyperglycemic agent that is used as a first line medical therapy to treat type 2 diabetes mellitus. It is also used to prevent progression of impaired glucose tolerance. It decrease hepatic glucose production and increase insulin sensitivity.
15867001|NCT03905668|Other|Video Monitoring|Patients may have video monitoring for up to seven days while in the ICU. The video system will be placed in an unobtrusive area in the patient's ICU room.
15867272|NCT03903640|Biological|Ipilimumab|-Standard of care
15866873|NCT03906682|Behavioral|Healthy Topics|Co-investigator Dr. Sibinga developed the Healthy Topics curriculum to function as an active control condition for randomized controlled trials in both clinic-based and school-based studies of mindfulness instruction for urban youth. Adapted from the Glencoe Health Curriculum (McGraw Hill), it was designed to control for the effects of a positive adult, time and attention, a small group learning environment, engaged instruction, and interesting material. The Healthy Topics curriculum has been successfully implemented as an effective active control condition, with student engagement and participation comparable to the intervention arm. The curriculum includes information about nutrition, exercise, sleep, drug use, and other topics related to physical health.
15866874|NCT03906669|Drug|Letrozole|PO daily for 14 days
15866875|NCT03906669|Drug|Letrozole and Prometrium|PO daily for 14 days
15866876|NCT03906669|Drug|Tamoxifen and Prometrium|PO daily for 14 days
15866877|NCT03906656|Device|C-Brace|The C-Brace consists of individually fabricated thigh, calf and foot components. An ankle joint, unilateral or bilateral fitting, or an individual spring element connects the foot and calf components. The sensor system continuously measures the flexion of the knee joint and its angular acceleration. This allows the C-Brace to detect the user's current walking phase, so it can regulate the hydraulic resistances as well as control the flexion and extension of the knee joint.
15866878|NCT03906656|Device|KAFO/SCO|Current knee ankle foot orthosis that the subject was wearing at baseline
15866879|NCT03906643|Drug|HS-201|HS-201 will be administered intravenously as a single dose
15866880|NCT03906630|Diagnostic Test|Telehealth clinical exam|This is a pseudo telehealth clinical exam for patients presenting with shoulder pain
15866881|NCT03906630|Diagnostic Test|Standard clinical exam|This is a standard in-person clinical exam for patients presenting with shoulder pain
15866882|NCT03906617|Drug|Intercostal nerve block and wound infiltration with liposomal bupivacaine|Intercostal nerve block and wound infiltration with liposomal bupivacaine during robotic lung resection surgery. 266mg of liposomal bupivacaine with 24 ml of 0.5% bupivacaine will be used.
15866883|NCT03906617|Drug|Intercostal nerve block and wound infiltration with bupivacaine/epinephrine + dexamethasone|Intercostal nerve block and wound infiltration with liposomal bupivacaine during robotic lung resection surgery. 42 ml of 0.5% Bupivacaine/epinephrine with 8mg dexamethasone will be used.
15866884|NCT03906604|Procedure|Carpal Tunnel Procedure (open)|Patients with bilateral CTS will have one side released with incisionless thread carpal tunnel release and the contralateral side released with the mini-open carpal tunnel release.
15866885|NCT03906591|Procedure|allogenic bone ring|allogenic bone ring with simultaneous dental implant placement
15866886|NCT03906591|Procedure|autogenous bone ring|autogenous bone ring with simultaneous dental implant placement
15866887|NCT03906578|Dietary Supplement|Vivomixx®|Microbiotic food supplement with L. paracasei, L. plantarum, L. acidophilus, L. delbrueckii, B. longum, B. infantis, B. breve, S. thermophilus
15866888|NCT03906578|Other|Placebo|Placebo with similar appearance to probiotic
15866889|NCT03906565|Drug|utidelone injection|utidelone monotherapy in patients with advanced or metastatic CRC by iv transfusing utidelone injection
15866890|NCT03906552|Other|nonpharmalogocial methods|neonates received acupressure (acupressure group) or massage (massage group) before heel lancing procedure
15866891|NCT03906539|Drug|Atorvastatin 10mg|Atorvastatin 10 mg per day
15866892|NCT03906539|Dietary Supplement|Virgin Coconut Oil (VCO)|Capsule VCO (1000 mg/day)
15866893|NCT03906539|Other|Placebo|Placebo capsule - 1 capsule per day
15866896|NCT03906513|Device|OMK2|OMK2 (including citicoline 2%, high molecular weight hyaluronic acid 0.2%, cyanocobalamin and 0.01% BAK, Omikron Italia SRL) is a Class IIa device CE marked registered in Medical Devices Database of Italian Ministry of Health (identification number of registration: 1170558).
15866897|NCT03906500|Behavioral|High schools High on Life|"The intervention consist of three main components.
~Environmental factors of the school environment
~The component targeting the high school environment consisted of two separate elements:
~Revision of school alcohol policy
~Appointment of coordinator(s) of student committees organizing events, where alcohol is sold, and student introduction committee.
~Student component
~The Student components consisted of three main elements:
~Online education for the student committees organizing events where alcohol is sold and the student introduction committee
~Pocket movie campaign competition
~Social norms campaign
~Parent component
~The parent component consisted of three separate elements:
~Parent Information Meeting
~Parent Information Folder
~Parent Information Website"
15866898|NCT03906487|Behavioral|Assessment measures MINI, PCL5 and BDI-II and definition of 5 SDM|"This group will have two visits:
~the first to verify inclusion criteria and assessed psychotraumatic and depressive symptoms by completing assessment measures called MINI, PCL-5, BDI-II ;
~the last to characterize the SDM by defining 5 personal memories"
15866899|NCT03906487|Behavioral|Assessment measures MINI and definition of 5 SDM|"This group will have two visits:
~the first to verify inclusion criteria and assessed psychotraumatic and depressive symptoms by completing MINI questionary;
~the last to characterize the SDM by and defining 5 personal memories"
15866900|NCT03906474|Biological|Blood-stage controlled human P. falciparum malaria infection|Volunteers will be challenged with malaria by administering a small amount of P. falciparum infected blood intravenously.
15866901|NCT03906461|Device|Radiofrequency Ablation|The Tacticath Contact Force Ablation Catheter, Sensor Enabled (TactiCath SE) is designed to facilitate electrophysiological mapping of the heart chambers and to transmit radiofrequency (RF) current to the catheter tip electrode for intracardiac ablation purposes.
15866902|NCT03906448|Combination Product|TTFields with adjuvant temozolomide|Patients will begin study treatment with temozolomide and TTFields within 2 weeks of the baseline evaluation, and no later than 6 weeks from last dose of concomitant temozolomide or radiation therapy (the latter of the two). A minimum of 6 and a maximum of 12 cycles of adjuvant temozolomide will be given, depending on tolerability and toxicity.
15866965|NCT03905928|Other|Nicotine Containing ECIG with tobacco flavor|"Participants will be provided with an EGO style ECIG to be used for 28 days. The EGO style ECIG is a vape pen-style device that comprises of a rechargeable battery and a tank containing liquid. Those in this intervention group will receive an ECIG with 18mg/ml nicotine concentration and a tobacco flavor."
15867403|NCT03902496|Device|Sham Spectacles|Sham
15866903|NCT03906435|Behavioral|Cognitive Behavioral Therapy|The intervention group will receive standard NICU and follow up care information plus a total of 5 CBT sessions split between the NICU and outpatient clinic visits post discharge from NICU. The CBT sessions will address PPCV in parents and parenting skills to address this. The CBT sessions will be standardized with a manual for study investigators to follow during sessions, and made with Dr. Richard Shaw from Stanford University, who wrote the prior CBT manual for anxiety, depression, and PTSD for NICU parents. Study staff will be trained to give the standardized CBT sessions using the manual via pilot sessions. There will be 3 CBT sessions given in the Parkland NICU before discharge and then 2 in the THRIVE follow up clinic at Children's Medical Center after discharge from the NICU.
15866904|NCT03906422|Device|3M Unitek 0.016 orthodontic archwire|Placement of 3M Unitek 0.016 archwire for orthodontic treatment
15866905|NCT03906422|Device|"Device: 0.016 Ormco 27oC NiTi orthodontic archwire"|"Placement of 0.016 Ormco 27oC NiTi orthodontic archwire"
15866906|NCT03906422|Device|"Device: 0.016 Ormco 35oC NiTi orthodontic archwire"|"Placement of 0.016 Ormco 35oC NiTi orthodontic archwire"
15866907|NCT03906409|Other|Constant|Participants will be provided with their daily energy requirements in a continuous drip across the day (1 ml/minute).
15866908|NCT03906409|Other|Bolus|Participants will be provided with their daily energy requirements in two bolus feeds. One at 08:00-08:15 and one at 20:00-20:15
15866909|NCT03906396|Device|Xbox 360 Kinect|A session 30 minutes of exercise game activities using the Xbox 360 Kinect will be performed by each participant. Games uses for the activity are Sports Kinect and Sports Kinect 2. Xbox 360 Kinect - the players themselves become the ''game controller'' via their body movements and gestures, Kinect-enabled game titles lend themselves comfortably to the class of exercise games.
15866910|NCT03906383|Other|Remote Ischemic Conditioning|Brief reversible restriction of blood flow to upper limb in four cycles of 5 minutes of inflation at 200mm Hg followed by 5 minutes of deflation.
15866911|NCT03906370|Diagnostic Test|Diagnostic criteria for MS|The diagnosis healthy/diseased was made by 2017 Mc Donald criteria.
15866912|NCT03906357|Drug|Pemigatinib|
15866913|NCT03906344|Drug|INCB052793|
15866915|NCT03906318|Drug|Itacitinib|
15866916|NCT03906305|Other|Dry needling in a myofascial trigger points area plus physical therapy based on Bobath concept|"Other: Dry Needling Participants will receive dry needling application over a myofascial trigger point by an experienced physical therapist with clinical experience in neurological patients, that will be inserted into taut bands of the following shoulder spastic muscles (when a trigger point was present): upper trapezius, supraspinatus, infraspinatus and deltoid anterior.
~Other: Physical Therapy
~Participants will receive physical therapy treatment based on the modulating Bobath technique. This technique will be applied using the general parameters, carrying out similar action protocols with every patient, based on the aim of normalizing upper limb muscle tone.
~Device: stainless steel needles (0.3mm x 50mm)"
15866917|NCT03906305|Other|Dry needling in a non myofascial trigger points area plus physical therapy based on Bobath concept|"Other: Dry Needling Participants will receive dry needling application carried out over a non trigger point area by an experienced physical therapist with clinical experience in neurological patients, that will be inserted into a non trigger point spastic muscle of the shoulder area: upper trapezius, supraspinatus, infraspinatus and deltoid anterior.
~Other: Physical Therapy Participants will receive physical therapy treatment based on the modulating Bobath technique. This technique will be applied using the general parameters, carrying out similar action protocols with every patient, based on the aim of normalizing upper limb muscle tone.
~Device: stainless steel needles (0.3mm x 50mm)"
15866918|NCT03906292|Drug|Imatinib|Imatinib 400 mg QD and asciminib 60 mg QD
15866919|NCT03906292|Drug|Nilotinib 300 mg|Nilotinib 300 mg BID and asciminib 20 mg BID or 40 mg QD
15866920|NCT03906292|Drug|Dasatinib|Dasatinib 100 mg QD and asciminib 80 mg QD
15866921|NCT03906292|Drug|Asciminib|Asciminib 80 mg QD Monotherapy
15866922|NCT03906266|Diagnostic Test|NRS 2002, nutric, SGA and adductor pollicis|NRS 2002, nutric, SGA and adductor pollicis tests detects the malnutrition
15866923|NCT03906253|Device|Fractionated Laser Resurfacing|A rejuvenating laser that makes tiny holes in the very superficial part of the skin.
15866924|NCT03906240|Behavioral|Moral Elevation intervention|The intervention will be administered twice per week for 8 sessions total. The intervention will include two types of moral elevation exercises related to witnessing virtuous behavior and subsequently setting session goals aimed to facilitate social engagement.
15866925|NCT03906227|Device|ENUMERATION OF CD5+ B Cells|A blood test is done to assess what percentage of CD5+ is present within CD19+. The result is then used to guide choice of arm.
15866926|NCT03906214|Other|Web-based Survey|"Participants will be directed to online forms to report general information (ex. age, sex, test results, family history), suspected medication-related acute attacks, and uneventful use of possibly risky medication. If a patient has multiple medication-related acute attacks, the patient/caregiver will be able to submit multiple report forms that will be linked. In addition to the report forms, patients will be asked to review a list of Medications of Interest and report current or past use."
15866927|NCT03906201|Dietary Supplement|Ecdysterone|Food supplement of plant origin with pronounced biological activity and potentially hypoglycaemic
15866928|NCT03906201|Other|Placebo|no pharmacologic effect
15866929|NCT03906188|Other|LitEmotion|LitEmotion is a serious video game programmed for helping managing emotions. The experimental group will play during 3 weeks while the control group will not play. The sample will play during 21 days, one session daily, around 45 minutes. After the 21 sessions the group will stop playing during 3 weeks. Therefore, the scales are done three times. In the very beginning (before playing), 21 days after playing, and, finally, 21 days no playing.
15866930|NCT03906175|Device|Whole-body hyperthermia|Whole-body hyperthermia will be applied two times during 4 weeks (week 0 and 2 after randomization). The hyperthermia will be applied using Heckel-HT3000 MPIIb.
15866964|NCT03905941|Drug|Oral combined hormonal contraceptives|"Oral combined hormonal contraceptive (OCs) with a combination of ethinyl estradiol 20 mcg/norethindrone acetate 1 mg will be used in this study. OCs are normally used to prevent pregnancy by suppressing ovulation and to prevent endometrial hyperplasia by inducing regular withdrawal bleeding. OCs help control both clinical and biochemical hyperandrogenism in PCOS and are considered first line medical therapy until the age of menopause."
15882781|NCT03783442|Drug|Oxaliplatin|30 mg/m2 IV on Day 1 Q3W
15866931|NCT03906162|Behavioral|Motivational interviews|"During the 12-week intervention, the participants will receive seven telephone calls from a physical therapist. The interviews will be held in week 1, 2,3,5,7,9, and 12.
~The telephone call will consist of a motivational interview focused on enhancing the daily level of physical activity in the participants.
~MI is a form of counselling aiming at prompting increases in self-efficacy, which may leave people more open to and invested in changing their behaviours and shows potential for significant effects for exercise behaviour change.
~In addition to the telephone based motivational interviews, the experimental group will also receive the base intervention which is described in detail under the control intervention paragraph."
15866932|NCT03906162|Behavioral|Base intervention|"The base intervention consists of a physical activity monitor (PAM) for everyday use in the intervention period and a pamphlet with information about Danish recommendations on physical activity in aging populations. The PAM will be the Garmin Vivofit 3 monitor linked to a pre-specified Garmin Connect account. The participants will be asked to install the Garmin Connect application on their smartphone and use the given ID/password in the app. The participants will be asked to wear the monitor 24-hours a day for the 12-week intervention period. The participants can use the PAM as they like but they will be asked to try to use the PAM and the application to enhance their daily level of physical activity."
15866933|NCT03906149|Combination Product|Whole-body hyperthermia + standard medical care|Whole-body hyperthermia will be applied two times during 4 weeks (week 0 and 2 after randomization) in addition to standard medical care. The hyperthermia will be applied using Heckel-HT3000 MPIIb. During the 6 weeks of primary observation, the current medication should be maintained. The dose may be optimized with respect to clinical effectiveness and the reduction of side effects. The type of medication should not be changed during the 6 weeks. The use of additional somatic therapies such as sleep deprivation, light therapy, electroconvulsive therapy, or transcranial magnetic stimulation is not allowed.
15866934|NCT03906149|Combination Product|Standard medical care|Standard medical care included guideline-based anti-depressive drug treatment in combination with psychotherapy. During the 6 weeks of primary observation, the current medication should be maintained. The dose may be optimized with respect to clinical effectiveness and the reduction of side effects. The type of medication should not be changed during the 6 weeks. The use of additional somatic therapies such as sleep deprivation, light therapy, electroconvulsive therapy, or transcranial magnetic stimulation is not allowed.
15866935|NCT03906136|Biological|Secukinumab/Adalimumab-Biosimilar|Secukinumab 150 mg, s.c. Secukinumab 300 mg, s.c. Adalimumab-Biosimilar, s.c.
15866936|NCT03906136|Other|Standard-of-care|Patients will receive treatment according to local practice standards by their treating physician following the current treatment recommendations.
15866937|NCT03906123|Drug|NBP|NBP soft capsules
15866938|NCT03906123|Drug|Placebos|Soft capsules manufactured to mimic NBP
15866939|NCT03906110|Behavioral|Community Colorectal Cancer Awareness, Research, Education & Screening (C-CARES) Materials|Educational materials (photonovella +DVD) + Fecal Immunochemical Test (FIT) kit. Offers colorectal cancer screening information using a novella format. Materials describe colorectal cancer and screening tests that are available, and procedures for completing FIT kit.
15866940|NCT03906110|Behavioral|Contact Message|Card with a general message about colorectal cancer screening. This same message will be delivered at 3 time points.
15866941|NCT03906110|Behavioral|Personalized One on One Education|"Trained study coordinators will meet with participant for a brief 15 minute educational session delivered in clinic that summarizes information from the materials and demonstrates FIT collection.
~Email or text reminders with brief messages in clear language will be sent that aim to remind and prompt patients to complete FIT.
~For participants that are not responsive to above, trained study staff will address specific FIT specific hinderances by telephone or in clinic.
~Participants will receive a one page summary of key points of salience of repeat screening GET FIT AGAIN. Another FIT kit is provided."
15866942|NCT03906110|Diagnostic Test|Fecal Immunochemical Test (FIT)|The Fecal Immunochemical Test (FIT), is a screening test that detects hemoglobin in stool samples, only requiring one stool sample.
15866943|NCT03906097|Other|Play and Competition-Based Cognitive Therapy|The intervention group was received play and competition-based cognitive therapy for 10 weeks, 3 days a week, 1 hour per day; the control group was the group who continued the special education program
15866944|NCT03906084|Procedure|Corticotomy and low laser therapy|Corticotomy is carried out under local anesthesia followed by low-intensity laser therapy that is started on the selected experimental side on the same day as placement of the coil spring
15866945|NCT03906084|Procedure|Corticotomy facilitated Orthodontics|Corticotomy is carried out under local anesthesia in right side.
15866946|NCT03906071|Biological|Nivolumab|Nivolumab is an antibody directed at the programmed death receptor-1 (PD-1), blocking its interaction with PD-L1 and PD-L2.
15866947|NCT03906071|Drug|Sitravatinib|Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.
15866948|NCT03906071|Drug|Docetaxel|Docetaxel is an anti-neoplastic agent that acts by disrupting the microtubular network in cells.
15866949|NCT03906058|Drug|Anlotinib|All patients enrolled in the study will accept anlotinib treatment as a palliative treatment .
15866950|NCT03906045|Drug|BGF-MDI|Budesonide, Glycopyrronium and Formoterol Fumarate.
15866951|NCT03906032|Device|TFNA IM Nail|IM nail
15866952|NCT03906032|Device|Sliding hip screw|SHS surgical fixation
15866953|NCT03906019|Procedure|ESP Block|Erector spinae plane block performed with 0,25% bupivacaine (0,5 mL/kg-max 20mL), under general anesthesia before the start of the surgery.
15866954|NCT03906019|Diagnostic Test|FLACC score|For up to 7 years old patients, Face, Legs, Activity, Cry and Consolability (FLACC) scores during postoperative 24h period.
15866955|NCT03906019|Diagnostic Test|NRS score|Patients older than 7 years, NRS scores during postoperative 24h period.
15866956|NCT03906006|Drug|ABP-671|Drug: ABP-671, single oral dose
15866957|NCT03906006|Other|Placebo|Other: Placebo, single oral dose
15866958|NCT03905980|Procedure|vaginal delivery|pregnancy ended by vaginal delivery
15866959|NCT03905980|Procedure|Cesarean section|pregnancy ended by cesarean delivery
15866960|NCT03905967|Procedure|TACE|TACE will be performed one day after oral administration of lenvatinib. TACE with either cTACE or DEB-TACE can be used, depending on the condition of each center.
15866961|NCT03905967|Drug|Lenvatinib|Lenvatinib will be taken within 3 days of randomization (dose: 8 mg qd for patients <60kg, and 12 mg qd for patients >60kg)
15866966|NCT03905928|Other|Nicotine Containing ECIG with Strawberry Vanilla Flavor|"Participants will be provided with an EGO style ECIG to be used for 28 days. The EGO style ECIG is a vape pen-style device that comprises of a rechargeable battery and a tank containing liquid. Those in this intervention group will receive an ECIG with 18mg/ml nicotine concentration and a strawberry vanilla flavor."
15866967|NCT03905928|Other|Placebo ECIG with Tobacco Flavor|"Participants will be provided with an EGO style ECIG to be used for 28 days. The EGO style ECIG is a vape pen-style device that comprises of a rechargeable battery and a tank containing liquid. Those in this intervention group will receive an ECIG with 0mg/ml nicotine concentration and a tobacco flavor."
15866968|NCT03905928|Other|Placebo ECIG with Strawberry Vanilla Flavor|"Participants will be provided with an EGO style ECIG to be used for 28 days. The EGO style ECIG is a vape pen-style device that comprises of a rechargeable battery and a tank containing liquid. Those in this intervention group will receive an ECIG with 0mg/ml nicotine concentration and a strawberry vanilla flavor."
15866969|NCT03905915|Device|Virtual reality (VR) session with AQUA module|A device with virtual reality is given to the patients with a film of 15 minutes
15866970|NCT03905902|Biological|DCVAC/OvCa|activated autologous dendritic cells
15866971|NCT03905902|Biological|DCVAC/OvCa placebo|placebo for activated autologous cells
15866972|NCT03905889|Drug|Abemaciclib|Subjects will by given oral Abemaciclib every 12 hours for 14 days followed by 7 days off (i.e. a 21 day cycle). The initial dose will be 100 mg (Dose level 1) followed by 150 mg (Dose Level 2) depending on tolerability and toxicity assessment of the combination of medications. If at Dose Level 1 subjects cannot tolerate the combination of medications, the Abemaciclib would not be increased, and the dose will remain stable at 100 mg (Dose Level -1).
15866973|NCT03905889|Drug|Sunitinib|Subjects will take oral Sunitinib daily for the 21-day cycle. Dosing will be at 50 mg for both Dose Levels 1 and 2. If the combination of the 2 medications is not tolerated by Subjects at Dose Levels 1 a lower dose of Sunitinib (37.5 mg) will be given (Dose Level -1).
15866974|NCT03905876|Other|Questionnaire|Questionnaire to evaluate psychological experience
15866975|NCT03905863|Device|Natrox® Oxygen Wound Therapy|A battery-operated device which delivers 98% pure humidified oxygen to the wound bed through water electrolysis via a sterile oxygen delivery system.
15866976|NCT03905850|Drug|somapacitan|5 mg/1.5 ml and 10 mg/1.5 ml doses administered s.c. (subcutaneously, under the skin)
15866977|NCT03905837|Drug|Lidocaine|Intravenous or paravertebral lidocaine
15866978|NCT03905837|Drug|Remifentanil|intravenous remifentanil
15866979|NCT03905824|Biological|Allogenic stromal mesenchymal cells derived from the umbilical cord|Platelet-poor plasma (PPP) scaffold embedded in allogenic stromal mesenchymal cells derived from the umbilical cord added to the traditional treatment for osteochondral lesions of the talus
15866980|NCT03905824|Procedure|Debridement and microfracture|Debridement and microfracture in LOC is the traditional treatment for osteochondral lesions of the talus
15866981|NCT03905811|Drug|Terazosin 5 MG|5 milligrams by mouth daily at bedtime
15866982|NCT03905811|Drug|Placebo oral capsule|1 capsule by mouth daily at bedtime
15866983|NCT03905798|Drug|Lorazepam|"The usual dose of lorazepam in adults is 4 mg administered intravenously. The drug should be given slowly with the administration rate at 2 mg/min as a guide. If necessary, 4 mg may be added but the dose should not exceed 8 mg as the sum of initial and additional doses.
~The usual dose of lorazepam in children aged 3 months or older is 0.05 mg/kg (up to 4 mg) administered intravenously. The drug should be given slowly with the administration rate at 2 mg/min as a guide. If necessary, 0.05 mg/kg may be added but the dose should not exceed 0.1 mg/kg as the sum of initial and additional doses."
15866984|NCT03905785|Behavioral|Samarthan|Samarthan intervention was designed as group program, training parents in cognitive-behavioural techniques for managing child's difficult behaviour and issues. Program was focused on parent-child problem solving method and positive interaction.
15866985|NCT03905772|Other|Voluntary exercise|The participants will perform 36 maximal voluntary contractions, 3 times per week for 8 weeks.
15866986|NCT03905772|Other|Wide pulse responder group|The participants will perform 36 contractions with the following current parameters: pulsed current (100 Hz, pulse duration 1 ms, Ton: 6 s, Toff: 18 s), 3 times per week for 8 weeks. This group will be classified in responder group in acute fase.
15866987|NCT03905772|Other|Wide pulse non responder group|The participants will perform 36 contractions with the following current parameters: pulsed current (100 Hz, pulse duration 1 ms, Ton: 6 s, Toff: 18 s), 3 times per week for 8 weeks. This group will be classified in non responder group in acute fase.
15866988|NCT03905772|Other|Pulsed current group|The participants will perform 36 contractions with the following current parameters: pulsed current (100 Hz, pulse duration 250 μs, Ton: 6 s, Toff: 18 s), 3 times per week for 8 weeks.
15866989|NCT03905759|Drug|Dronedarone|Dronedarone (200 mg twice daily starting from day before operation till 5 days after)
15866990|NCT03905759|Drug|Amiodarone|Group A:-amiodarone (200 mg three times per day)21 administered 6 days prior to surgery through 6 days after surgery
15866991|NCT03905759|Drug|Colchicine|Colchicine will be used at the dose of 1 mg orally, twice daily, preoperatively (1 days), and of 0.5 mg, twice daily, until hospital discharge
15866992|NCT03905746|Other|blood sample at Day 0|"40mL blood (plasma and PBMCs) will be performed at D0 (inclusion), at the time of routine exams.
~(20 ml will be used for study analyzes ; 20mL will constitute the biological collection)"
15866993|NCT03905746|Other|blood sample at Day 2 and Day 7|20mL blood (plasma and PBMCs) will be performed at Day 2 and Day 7 from recruitment, at the time of routine exams. These two samples will constitute the biological collection.
15866994|NCT03905746|Other|stool sample at Day 0|stool sample (2mL) will be performed at D0 (inclusion), at the time of routine exams.
15866995|NCT03905733|Device|Optiflow|supply of oxygen at 2 L / min/ kg through Optiflow
15867002|NCT03905668|Other|Accelerometer Monitoring|Patients may have accelerometer monitoring for up to seven days while in the ICU. Commercially available accelerometer units, which have been validated in previous clinical studies, will be used.
15867003|NCT03905668|Other|Electromyographic Monitoring|Patients may have electromyographic monitoring for up to seven days while in the ICU.
15867004|NCT03905668|Other|Noise Level Monitoring|Patients may have noise level monitoring (in decibels) for up to seven days while in the ICU.
15867005|NCT03905668|Other|Light Level Monitoring|Patients may have light level monitoring for up to seven days while in the ICU.
15867006|NCT03905655|Drug|Placebo Oral Tablet|Number of placebo tablets administered orally depends on the arm
15867007|NCT03905655|Drug|Nitazoxanide|Number of Nitazoxanide 300 mg extended release tablets administered orally depends on the arm
15867008|NCT03905642|Drug|Arikayce™|Amikacin (aminoglycoside) in a liposomal formulation.
15867009|NCT03905629|Other|None (retrospective observational study)|"This multi-centric retrospective observational cohort study is conducted using the PMSI. Predictive ability of HFRS estimated on the basis of 3 binary outcomes: 30-day in-patient mortality (main outcome), 30-day emergency and potentially avoidable readmission, length of stay >15 days. Odds ratios (ORs) and c-statistics calculated and compared to the original UK results in order to validate the use of the HFRS in France. Other secondary objectives include:
~Evaluate agreement between HFRS and Charlson or Elixhauser comorbidity indices
~Evaluate ability of HFRS combined with comorbidity indices (Charlson on one hand, and Elixhauser on other hand), to predict 30-day in-patient mortality, 30-day emergency and potentially avoidable readmissions, and long length of stay
~Identify specific risk associations in France of a high risk of frailty (as assessed by the HFRS) with individual, organizational and territorial factors"
15867010|NCT03905616|Device|functional Magnetic Resonance Imaging|In a 2-hour session, the subject we be shown different control and experimental conditions (all being visual stimuli) in perceptive tasks.
15867011|NCT03905603|Drug|ACTH|ACTH (Cosyntropin) 250 mcg will be given once during the study.
15867012|NCT03905603|Drug|rhCG|rhCG (Ovidrel) 250 mcg will be given once during the study.
15867013|NCT03905590|Procedure|Periapical surgery with amniotic membrane|periapical surgery will be done followed by amniotic membrane placement over the defect
15867014|NCT03905590|Procedure|periapical surgery without amniotic membrane|periapical surgery will be done without placement of membrane over the defect.
15867015|NCT03905577|Behavioral|Action Observation|Action Observation training
15867016|NCT03905577|Behavioral|Motor imagery|Motor imagery protocol
15867017|NCT03905577|Behavioral|Placebo Action observation|Placebo Action Observation
15867018|NCT03905564|Drug|doxylamine succinate 10 mg/pyridoxine hydrochloride 10 mg combination|Delayed-release tablet containing a fixed-dose combination of doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg (product of Tecnandina, S.A. TENSA).
15867019|NCT03905564|Drug|Diclegis (Registered Trademark)|Delayed-release tablet containing a fixed-dose combination of doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg (product of Duchesnay Inc.).
15867020|NCT03905551|Procedure|Cold Dialysis|Dialysate temperature reduced to 35oC for a period of 7 months.
15867021|NCT03905551|Procedure|Typical Dialysis|Dialysate temperature is set at 37oC for a period of 7 months
15867022|NCT03905551|Procedure|Exercise|Aerobic Intradialytic exercise training
15867023|NCT03905538|Drug|[18F]FLT-PET/CT|Dose of 0.07 mCi/Kg [18F]FLT to max of 5 mCi (± 20%) will be given intravenously.
15867026|NCT03905512|Drug|SEL-212|SEL-212
15867027|NCT03905512|Drug|SEL-037|SEL-037, PEGylated uric acid specific enzyme (uricase)
15867028|NCT03905512|Drug|SEL-110|ImmTOR (SEL-110)
15867029|NCT03905512|Drug|KRYSTEXXA®|KRYSTEXXA®, PEGylated uric acid specific enzyme (uricase)
15867030|NCT03905499|Device|Robotic mediated therapy with MJS (multi joint system) Tecnobody|The intervention will include 18 30-minutes trainings evenly distributed over a time period of 6 weeks and will be administered by the same two physiotherapists at the Schulthess clinic based on the standardized protocol
15867031|NCT03905486|Drug|Pregabalin 300mg|Group 1: will receive pregabalin as a monotherapy. Pregabalin will be administered according to the treatment recommendations for fibromyalgia in the package insert [Pfizer Inc., 2012] starting by 50 mg twice daily increasing to 300 mg twice daily according to the efficacy and tolerability for 3 months.
15867032|NCT03905486|Drug|Combined pregabalin 300mg and milancipran 100mg|Group 2: will receive a combined pregabalin and milancipran. Pregabalin will be administered as group 1, while milancipran will be administered according to the treatment recommendations for fibromyalgia, starting by 50 mg once daily for 1 week then increased to reach 100 mg daily (50 mg twice daily) based on efficacy and tolerability for 3 month.
15867033|NCT03905473|Behavioral|Accelerometer measurements|To validate the questionnaires about physical activity, some patients will be wearing an accelerometer for one week. An accelerometer is a little device worn in a belt around the hip, which can measure intensity of the patient's activity level. The accelerometer is worn 24 hours a day for one week and is only removed when bathing.
15867034|NCT03905460|Diagnostic Test|Point-of-care ultrasound|Focused ultrasound of the heart, lungs and pleurae
15867035|NCT03905447|Drug|PC945|Nebulized PC945 5mg OD for 28 days with an optional extended treatment period of a further 56 days.
15867036|NCT03905447|Drug|Standard of Care|Standard of Care antifungal medication
15867038|NCT03905408|Drug|50 mL of 50% Glucose|1st dose
15867039|NCT03905408|Drug|100 mL of 50% Glucose|2nd dose
15867040|NCT03905408|Drug|150 mL of 50% Glucose|3rd dose
15867041|NCT03905408|Drug|200 mL of 50% Glucose|4th dose
15867042|NCT03905395|Behavioral|Meditation and mindfulness|Women in the intervention arm will 3 times receive a three hours work shop with introduction to meditation and mindfulness over a 7 week period from a certified meditation instructor. Questionnaires before and after the intervention.
15867043|NCT03905382|Other|Qualitative|Focus group and 1:1 telephone interviews
15867404|NCT03902483|Device|renal doppler ultrasound|renal doppler ultrasound measuring renal resistive index
15867044|NCT03905369|Other|Decision aid and SDM booster|The investigators develop the decision aid and SDM booster. The scope of the investigators of decision making combines the clinical and patient perspective. The decision aids are developed for patients with TC either newly diagnosed or patients with advanced disease, presently in the follow-up at the participating centers, covering the whole treatment trajectory of these patients (Figure 4). Three treatment decisions are considered: 1) the extent of thyroid resection, 2) the use of RAI, and 3) the initiation of TKIs.The SDM-booster is developed alongside the decision aids, as the SDM-booster (or values clarification exercise) is often a component developed together with a decision aid. The SDM-booster aims to shape patients' values regarding aspects of the decision and ensuing treatment preferences.
15867045|NCT03905369|Other|Deliberation training|The investigators develop the deliberation training. It makes physicians more aware and responsive to patients' values. The communication training for physicians will consist of 1) an e-learning SDM-training lasting 40 minutes and, 2) an individual values deliberation training lasting 2 hours.
15867046|NCT03905356|Behavioral|Exercise Therapy|Certified exercise oncology specialists will personalize, prescribe, and guide ET, including twice weekly resistance training and walking, performed at home, with supervision in the Exercise Medicine Unit. The cancer exercise physiologist will teach participants proper warm ups, use of equipment, exercise form, modes of activity, intensity of exercise, flexibility exercises, and cool down. In addition, patients will be instructed to exercise on their own, at home, according to the instructions from the cancer exercise specialist.
15867047|NCT03905343|Drug|Ribociclib|Ribociclib 600mg p.o. d1-21, q4w in combination with endocrine treatment for 3 years.
15867048|NCT03905343|Other|Mono-chemotherapy|mono-chemotherapy for at least 12 weeks (afterwards, maintenance endocrine therapy ± ribociclib inhibitor is allowed) and up to 3 years.
15867049|NCT03905343|Other|Endocrine-Therapy|The choice of endocrine therapy is up to the investigator, but the chosen endocrine therapy has to be registered to be used in combination with ribociclib in the investigated indication.
15867050|NCT03905330|Drug|Maralixibat|Maralixibat oral solution (up to 600 mcg/kg) orally twice daily for 26 weeks.
15867051|NCT03905330|Other|Placebo|Placebo matching to maralixibat orally twice daily for 26 weeks.
15867052|NCT03905317|Drug|Bevacizumab Injection|Bevacizumab maintenance therapy starts 1-2 months later after the chemotherapy.The recommended dose for intravenous infusion is 15mg/kg body weight, and the drug is given every 3 weeks until disease progression or intolerable toxicity occurs.
15867053|NCT03905317|Radiation|chest radiation|The patients receive SBRT radiotherapy for the primary (if any) and metastatic lesions or divided radiotherapy with or without concurrent chemotherapy.
15867054|NCT03905317|Drug|concurrent chemotherapy|weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with chest radiation
15867055|NCT03905304|Biological|Medytoxin|Intramuscular injection up to 300U.
15867056|NCT03905304|Biological|Botox|Intramuscular injection up to 300U.
15867057|NCT03905291|Drug|MT921|Formulated as an injectable solution
15867058|NCT03905291|Drug|Placebo|normal saline
15867059|NCT03905278|Behavioral|Parental guidance|A psychological intervention including 4 sessions to assess how participants communicate with their children about the disease and take stock of their questions and difficulties. To identify children's reactions and needs. Practical situation are analyzed and worked through role play centered on communicational difficulties to enhance communicational self-efficacy and mutual support among participants. Emotional regulation strategies are learned through relaxation exercises. A relaxation booklet is given to the participants to practice at home too. Moreover, all participants receive an informational booklet containing age-appropriate recommendations on communication with children about cancer.
15867060|NCT03905265|Drug|Moxidectin Oral Product|The required number of moxidectin 2 mg oral tablets will be administered as a single dose with placebo to match as required
15867061|NCT03905252|Other|sample analysis|blood, Random urine sample and 24-hour urine samples
15867062|NCT03905239|Diagnostic Test|algorithm|clinical examination and procalcitonin assessment
15867063|NCT03905213|Device|dressing MEPORE|assignation to three different authorised and on label dressing: conventional dressing (MEPORE)
15867064|NCT03905213|Device|dressing MEPILEX|assignation to three different authorised and on label dressing: absorbent(MEPILEX)
15867065|NCT03905213|Device|dressing PICCO|assignation to three different authorised and on label dressing:vacuum Therapy dressing(PICCO)
15867066|NCT03905200|Diagnostic Test|3D-speckle tracking imaging|The strain peak value and strain peaking time of each segment (including 16 segments) of the left ventricular myocardium can be obtained by 3d-sti technology.
15867067|NCT03905187|Behavioral|Modified CR|Stress management involved modified cardiac rehabilitation
15867068|NCT03905187|Behavioral|Traditional CR|Traditional cardiac rehabilitation
15867069|NCT03905187|Behavioral|Education|Education
15867070|NCT03905174|Device|custom made device|surgical intervention to place custom made orthopaedic device
15867071|NCT03905161|Other|6-minute walk test|The 6-minute walk test (6MWT) is widely used in the clinic to measure treatment efficacy and disease progression in patients with neuromuscular diseases and is found valid and reliable to measure decrease in walking speed for neuromuscular patients.
15867072|NCT03905148|Drug|Lifirafenib|RAF Dimer Inhibitor
15867073|NCT03905148|Drug|mirdametinib|MEK Inhibitor
15867074|NCT03905135|Drug|rhIL-15|IL-15 will be administered by continuous intravenous infusion in a dose-escalation fashion with a starting dose of 1 mcg/kg/day, a second dose level of 2 mcg/kg/day, a third dose level at 3 mcg/kg/day, and a fourth dose level at 4 mcg/kg/day on days 1-5 of each of six cycles.
15867075|NCT03905135|Biological|Avelumab|Avelumab (IV over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.
15867076|NCT03905122|Device|bioreactans tool|It is a completely non-invasive method by bioreactance method and it can be done to measure the intra-body fluid status with the help of the probes.
15867077|NCT03905109|Drug|ABX464|ABX464 is a new anti-inflammatory drug. In the treatment arm, patients will receive 50 mg of ABX464 orally once daily during 112 days.
15867078|NCT03905109|Drug|Placebo|In the placebo group, patients will receive 50mg ABX464-matching-placebo orally once daily during 112 days.
15867079|NCT03905096|Drug|BI 425809|Film coated tablet
15867080|NCT03905096|Drug|Donepezil|Film coated tablet
15882782|NCT03783442|Drug|Tislelizumab|200 mg IV Q3W
15867081|NCT03905083|Other|Exercise Rehab|Participants who do the Exercise Rehab will engage in up to four center-based exercise rehab sessions each week for approximately 12 weeks; each session lasting roughly 1-hour with a stimulus (exercise) phase and a mix of warm up and cool down. Cycle ergometer and treadmill exercise may be used.
15867082|NCT03905057|Device|Dornier Aries 2 (with active applicator)|Active ESWT: 5000 shockwaves per session. 2 ESWT sessions per week, 12 sessions in total.
15867083|NCT03905057|Device|Dornier Aries 2 (with sham applicator)|Sham ESWT - No shockwave administered
15867084|NCT03905044|Other|eyes with congenital cataracts|observation
15867085|NCT03905031|Device|InfraScanner 2000|The InfraScanner is a portable screening device that measures lateralized differences in optical density (OD) to determine the presence of intracranial hematoma. A difference in OD>0.2 is abnormal and suggestive of intracranial hematoma.
15867086|NCT03905018|Drug|Tadalafil 20 MG|tadalafil 20 mg orally ,after a single administration
15867087|NCT03905005|Procedure|Mandibular reconstruction with free tissue transfer.|Mandibular reconstruction with free tissue transfer (free-flap bony reconstruction) requires the use of a titanium plate to secure bony segments until bony healing is complete. Plates are made of titanium but can be customised to the anatomical shape of the mandible by two different techniques: flexing (bending) of the plate before surgery, or printing of the plate from titanium alloy powder bed fusion techniques (additive manufacturing, such as selective laser melting).
15867088|NCT03904992|Other|Progressive web app|Access to a progressive web app for the promotion of healthy habits in preescholers through the participant's smatphone
15867089|NCT03904979|Other|Writing exercises|Participants will be given journals with writing prompts to be completed throughout their pregnancy.
15867090|NCT03904966|Device|Kinesio tape|Kinesio tape will be applied on the plantar heel (the most painful area) of the patients for the treatment of plantar fasciitis, in addition to the extracorporeal shock wave therapy
15867091|NCT03904966|Device|Extracorporeal shock wave therapy|Extracorporeal shock wave therapy will be used for all patients with plantar fasciitis. (5 sessions for 5-week)
15867092|NCT03904953|Other|Pilates Training|Clinical pilates exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.
15867093|NCT03904953|Other|Conventional exercise programme|Stretching of erector spine, hip flexors, hamstring muscles and gastro-soleus muscles; back-strengthening of cervical, thoracic and lumbar spine and posture exercises will be taught to the patients in the first session and the patients will be requested to repeat the exercises three times a week for 8 weeks individually at home.
15867094|NCT03904940|Device|Total Contact Insole|Ethyl vinyl acetate insole shaped in the cast of the patient's foot.
15867095|NCT03904940|Device|Ethyl vinyl acetate flat insole|Flat insole made of the same material ethyl vinyl acetate
15867096|NCT03904927|Other|Radiation, Surgery or Radiofrequency ablation|Patients with no more than 4 metastases located in less than 2 organs/ lymphatic drainage regions treated with combined chemotherapy and radiation, surgery or radiofrequency.
15867097|NCT03904927|Drug|Chemotherapy|"First-line chemotherapy (previously without chemotherapy), paclitaxel 175mg/m2, d1+cisplatin 25mg/m2, d1-3, repeated every 28 days, intravenous infusion, a total of 4 cycles.
~If patients have a history of chemotherapy, use a regimen of docetaxel 75mg/m2, d1, intravenous infusion, repeated every 21 days for a total of 4 cycles. If previously use docetaxel but not irinotecan, then use a regimen of irinotecan 180mg/m2, d1, d15, repeated every 28 days for a total of 4 cycles. If both docetaxel and irinotecan have been used, the investigator could decide the chemotherapy regimen."
15867098|NCT03904914|Other|TOCI|TOCI staging evaluated
15867099|NCT03904901|Dietary Supplement|Probiotics|Individuals will receive individual capsules containing the daily dose of lyophilized probiotics (Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus lactis, Bifidobacterium lactis and Bifidobacterium bifidum) and will be advised to remain at room temperature, ingest with water and drink before bed.
15867100|NCT03904901|Dietary Supplement|Placebo|The placebo product had only the excipient, microcrystalline cellulose, and was identical to the active product in relation to color, shape, size and packaging.
15867101|NCT03904888|Procedure|r-TAPP|Robot-assisted repair
15867102|NCT03904888|Procedure|l-TAPP|Laporoscopic repair
15867103|NCT03904888|Procedure|local anesthetics|local anesthetics will be administred
15867104|NCT03904875|Other|collection of data about each acute exacerbation of COPD|COPD is chronic obstructive pulmonary disease. Data collected are need of hospitalisation, final diagnosis, home address, work address and air quality data.
15867105|NCT03904862|Drug|CX 4945|CX-4945 is supplied as 200 mg capsules delivered orally as a formulated API
15867106|NCT03904849|Drug|Cannabidiol|Cannabidiol oral solution
15867107|NCT03904849|Drug|Placebo|Placebo oral solution
15867108|NCT03904836|Drug|Tobramycin|5 milligrams per kilogram intravenous for one dose
15867109|NCT03904823|Drug|famitinib po|Patients would be treated with famitinib po combined with HS-10296 po till progression disease or withdrawal from the study.
15867110|NCT03904823|Drug|HS-10296 po|Patients would be treated with famitinib po combined with HS-10296 po till progression disease or withdrawal from the study.
15867111|NCT03904810|Behavioral|Exercise intervention|HIIT groups performed 30-meter shuttle runs on a rooftop covered field whereas MICT group ran on a footpath with an overall flat and non-slippery road surface. All training sessions were preceded by a 5-minute self-pace warm-up jogging and ended with a 5-minute self-pace jogging or walking cool-down. Each session of MICT consisted of 30 minutes of continuous exercise at an intensity of 60% of heart rate reserve (HRR); [i.e., (maximal HR - resting HR) × intensity + resting HR]. For each HIIT session, the intensity was set at 90% HRR for high-intensity bouts, interspersed with active recovery at 70% HRR. All exercise sessions were supervised by qualified athletic coach or strength and conditioning coach.
15867147|NCT03904550|Drug|Cisatracurium + Neostigmine|Maintenance neuromuscular blockade with boluses of cisatracurium to keep train-of-four (TOF) 1-2 twitches. For reversal, neostigmine with glycopyrrolate
15867148|NCT03904550|Drug|Rocuronium + Sugammadex|Maintenance neuromuscular blockade with boluses of rocuronium to keep TOF 1-2 twitches. For reversal, sugammadex
15867149|NCT03904537|Biological|anti-PD-1 antibody-activated TILs|Participants would received one dose anti-PD-1 antibody-activated TILs at the final cycle of XELOX regimen chemotherapy
15868319|NCT03895307|Other|kinesio tape|two 15 cm I type kinesio tape applied longitudinally
15867112|NCT03904797|Behavioral|Young Children's Participation and Environment Measure (YC-PEM) electronic patient-reported outcome (e-PRO)|"Participants were primary caregivers (n=149) recruited from a large, urban early intervention program. All caregivers were approached by early intervention staff the month prior to the child's annual evaluation of progress.
~Each caregiver confirmed his or her eligibility online by verifying that they were at least 18 years old; could read, write, and speak English or Spanish; had internet access; and had a child between 0-3 years old who had received early intervention for at least 3 months.
~Participants enrolled online and provided consent, signed a HIPAA authorization for service record release, and then proceeded to completing a demographic questionnaire and YC-PEM e-PRO to receive an online report of their responses to share with their child's EI team."
15867113|NCT03904784|Behavioral|school withdrawal teenagers|The teenagers will have 4 interview with medical team alone or with his familly in order to have questionnaries, schools reports, psychological evaluation.
15867114|NCT03904771|Behavioral|Nutrition counselling + peer support|Behavioral nutrition counselling and peer support, delivered in small groups. Includes six sessions extending over 8 weeks, with participatory activities facilitated by a nutrition therapist.
15867115|NCT03904771|Behavioral|Social activation + peer support|Social activation and peer support, delivered in small groups. Includes six sessions extending over 8 weeks, with participatory activities facilitated by group leader.
15867116|NCT03904758|Diagnostic Test|Pepsin in saliva test|The presence of pepsin in the saliva will be tested in both groups of patients.
15867117|NCT03904745|Drug|Atosiban|6,75mg of atosiban will be administered intravenously 30 minutes before embryo transfer
15867118|NCT03904732|Drug|Acetylsalicylic Acid (Aspirin, BAYE4465)|Low-dose acetylsalicylic acid, Aspirin (75-150 mg)
15867119|NCT03904719|Drug|CM082 plus JS001|CM082: 150mg once a day orally (taken within half an hour after breakfast) JS001: An intravenous infusion of a solution having a concentration of 1-3mg/ml was prepared with 0.9% physiological saline, and administered once every three weeks. Using an inline filter (0.2 or 0.22 μm), the drug was diluted with physiological saline and intravenously administered within 60 minutes.
15867120|NCT03904706|Other|Audits only|Formalized audit teams with monthly meetings at each facility.
15867121|NCT03904706|Other|Audits with community feedback|This intervention will implement the audits as described in arm 1; however, key community representatives (approximately 3-5 members) will be identified to attend monthly follow-up meetings with audit team leaders to discuss the community aspects (phase one and two-delays) that could have prevented the death, near miss or severe adverse outcome. Information regarding the cause(s) of death in the community will be collected by the LHW or CMW, who reports to the health facility on a monthly basis.
15867128|NCT03904680|Drug|Methotrexate|Methotrexate 2.5 mg tablet
15867129|NCT03904680|Drug|Vitamin D|Vitamin D 200,000 IU ampules
15867130|NCT03904667|Other|Watson on oncology surgery decision evaluation|Watson on oncology surgery decision evaluation. The system acquires and evaluates a large amount of structured and unstructured data from previous medical records through machine learning and natural language processing, and USES algorithms to select treatment options as the best choice for a particular patient.
15867131|NCT03904654|Behavioral|Mindfulness-based cognitive therapy (MBCT)|MBCT is an evidence-based psychotherapy which combines mindfulness skills with cognitive therapy strategies.
15867132|NCT03904641|Radiation|aPDT|For aPDT, PapacarieMblue (Fórmula e Ação) will be used. It will be left for 5 minutes in the cavity. The carious tissue will be removed and the application of the PapacarieMblue will be repeated. The tissue will then be irradiated in a single spot with a red laser, of wavelength of 660 nm, for 300 s, with the energy of 500mJ.
15867133|NCT03904641|Procedure|ART|Removal of infected dentin with a curette only, followed by cavity cleaning and restoration with glass ionomer cement.
15867134|NCT03904628|Drug|TG02 capsules oral administration, BIW in every 28d|TG02 capsules150mg oral administration, BIW in every 28d
15867135|NCT03904628|Drug|TG02 capsules oral administration, BIW in every 28d|TG02 capsules 200mg oral administration, BIW in every 28d
15867136|NCT03904628|Drug|TG02 capsules oral administration, BIW in every 28d|TG02 capsules 250mg oral administration, BIW in every 28d
15867137|NCT03904615|Dietary Supplement|Whey Protein|30 g of whey protein in flavored water, twice daily, during hospitalization and for 30 days post-discharge
15867138|NCT03904615|Dietary Supplement|Collagen Protein|30 g of collagen protein in flavored water, twice daily, during hospitalization and for 30 days post-discharge
15867139|NCT03904615|Dietary Supplement|Placebo|30 g of maltodextrin in flavored water, twice daily, during hospitalization and for 30 days post-discharge
15867140|NCT03904602|Device|Edema Wear fuzzy wale compression garment|net-like compression structure of Lycra spandex elastic yarn with longitudinal fuzzy wales (similar to corduroy fabric)
15867141|NCT03904589|Diagnostic Test|Quality of Life assessment|Quality of life will be assessed by means of the Seattle Angina Questionnaire and the Patient Health Questionnaire.
15867142|NCT03904576|Drug|BI 1358894|Film-coated tablet
15867143|NCT03904576|Drug|Placebo|Film-coated tablet
15867144|NCT03904563|Drug|Bevacizumab|Every patients are treated with 6 courses of Bevacizumab 1-2 months after the chemoradiotherapy.The recommended dose for intravenous infusion is 15mg/kg body weight, which is given every 3 weeks for 6 courses.
15867145|NCT03904563|Radiation|chest radiation|split-course chest radiation
15867146|NCT03904563|Drug|concurrent chemotherapy|weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with chest radiation
15867150|NCT03904524|Behavioral|SET-to-Meet|The overall objective of this study is to pilot test, in advance of a larger randomized trial, a scalable, nurse-led intervention to ensure timely interdisciplinary family meetings are held on behalf of critically-ill ICU patients who cannot participate in discussions about their care.
15867151|NCT03904511|Other|Souroubea-Platanus Preparation|Extracts of S. Sympetala and P. occidentalis.
15867152|NCT03904511|Other|Placebo|Placebo
15867153|NCT03904498|Drug|Tolcapone|Tolcapone 100 mg tablets
15867154|NCT03904498|Drug|Placebo|Placebo tablets
15867155|NCT03904485|Radiation|cardiac magnetic resonance(CMR) T2 mapping|T2 value before transplant，3 month and 6month after transplant
15867156|NCT03904472|Behavioral|Web-based CBTI|Sessions comprise a range of cognitive and behavioral techniques and psychoeducation including sleep hygiene. During the intervention period the participant will complete daily online sleep diaries. Additionally, participants will be asked to complete multiple questionnaires.
15867157|NCT03904459|Other|no intervention|
15867158|NCT03904446|Drug|Methylergonovine|0.2 mg of intramuscular methylergonovine at the time of cesarean section following standard IV oxytocin infusion.
15867159|NCT03904446|Drug|Normal Saline (placebo)|1 ml of normal saline intramuscular at the time of cesarean section following standard IV oxytocin infusion
15867160|NCT03904433|Other|Coconut oil|Coconut oil given in coffee with cream
15867161|NCT03904433|Dietary Supplement|Caprylic acid|Caprylic acid given in coffee with cream
15867162|NCT03904433|Other|Sunflower oil|Sunflower oil given in coffee with cream
15867163|NCT03904433|Other|Glucose|Glucose dissolved in water
15867164|NCT03904420|Other|Clinical Education and Treatment Model|Patients will have self directed equipment education and standardized programming approaches
15867165|NCT03904420|Other|Traditional Model|Standard clinical practice and education
15867166|NCT03904407|Other|Lactobacillus Probiotic Capsule|"One over-the-counter, probiotic capsule taken by mouth once daily for 4 weeks. Each capsule contains 10 billion cells comprised of:
~Lactobacillus crispatus LbV 88
~Lactobacillus jensenii LbV 116
~Lactobacillus gasseri LbV 150N
~Lactobacillus rhamnosus LbV 96"
15867167|NCT03904407|Other|Matching Lactobacillus Probiotic Placebo Capsule|Lactobacillus Probiotic placebo capsules identical in appearance taken by mouth once daily for 4 weeks
15867168|NCT03904394|Other|Exercise|Four sets of 7 minutes at 65% of VO2peak interspersed with 3 min of passive recovery
15867169|NCT03904381|Drug|5-fluorouracil|5-fluorouracil subconjunctival injections were a first-choice therapy for bleb failure and were administered according to predetermined criteria.
15867170|NCT03904381|Procedure|Transconjunctival needling|Transconjunctival needling was administered according to predetermined criteria.
15867171|NCT03904381|Procedure|Transconjunctival revision|Transconjunctival revision was administered according to predetermined criteria.
15867172|NCT03904368|Procedure|Open myomectomy|laparotomy then enucleation of the myoma followed by closure of the myometrial cavity
15867173|NCT03904368|Drug|Gonadotropins|Gonadotropin stimulation of follicular growth
15867174|NCT03904368|Drug|Human chorionic gonadotropin|HCG triggering of ovulation
15867175|NCT03904368|Procedure|Ovum pick up|34 to 36 hours after HCG triggering
15867176|NCT03904368|Procedure|Embryo transfer|Transfer of 2 grade 1 embryo on day 2,3 or 5 from oocyte retrieval
15867177|NCT03904355|Drug|Gonadotropins|Gonadotropin stimulation of follicular growth
15867178|NCT03904355|Drug|human chorionic gonadotropin|HCG triggering of ovulation
15867179|NCT03904355|Procedure|Ovum pick up|34 to 36 hours after oocyte retrieval
15867180|NCT03904355|Procedure|Embryo transfer|Transfer of 2 grade 1 embryo on day 2,3 or 5 from oocyte retrieval
15867181|NCT03904342|Behavioral|Sophie CBT System|The Sophie CBT system is a tablet-based system that delivers self-paced cognitive behavioral therapy educational curriculum in the format of 6 discrete modules.
15867182|NCT03904342|Behavioral|iHope CBT|Licensed therapists will use the iHope HIPAA-compliant telemedicine platform to deliver cognitive behavioral therapy to patients via telephone, videoconferencing, and/or text chat.
15867183|NCT03904329|Drug|Oral Anticoagulant|Oral tablets of anti coagulations either warfare or NOACs
15867184|NCT03904316|Biological|Biodesign Otologic graft|Acellular matrix derived from porcine small intestine submucosa
15867185|NCT03904316|Other|Autologous temporalis fascia|An autologous graft for tympanic membrane repair
15867186|NCT03904303|Drug|A 06 ad|Colonic cleansing before colonoscopy and CT colonografi
15867187|NCT03904290|Other|PFO Closure|Subject will undergo percutaneous closure of PFO/ASD utilizing FDA-approved PFO/ASD closure device(s).
15867188|NCT03904264|Device|Receiver in the canal (RIC) hearing aids|The RIC hearing aids fitted to subjects in arm 1 of the study will be manufactured by Widex.
15867189|NCT03904251|Drug|Gemtuzumab Ozogamicin|Given IV
15867190|NCT03904251|Drug|Liposome-encapsulated Daunorubicin-Cytarabine|Given IV
15867191|NCT03904238|Behavioral|Cognitive-Behavior Therapy for Hypersomnia (CBT-H)|"The CBT-H intervention consists of 6 weekly sessions that are conducted either individually or in small groups. Each session is expected to last about 45 to 60 minutes and will be delivered a study therapist using live videoconferencing or in-person. The treatment package consists of cognitive and behavioral modules that include education about hypersomnia, coping skills training, emotion regulation regarding the perceived limitations of living with chronic hypersomnia (e.g., I cannot live a full life because of my illness), and behavioral techniques using scheduled naps, sleep hygiene, and regularizing sleep schedules at night which are on the current optional recommendations for hypersomnia."
15867192|NCT03904225|Drug|Tegafur-Gimeracil-Oteracil|oral administration for 12 months
15867193|NCT03904212|Procedure|Adipose tissue injection|Injection with freshly harvested autologous adipose tissue
15867194|NCT03904212|Procedure|saline|injection with saline
15867195|NCT03904199|Drug|Insulin|Participants will receive long-acting insulin and/or rapid-acting insulin per protocol
15867221|NCT03904004|Procedure|Peroral endoscopic myotomy|Endoscopic myotomy after performing a tunnel to reach the muscular layer through a mucosal incision
15867222|NCT03904004|Procedure|Neumatic dilatation|Inflation of a ballon of specific diameter in the gastro-oesophageal junction
15868320|NCT03895307|Other|local anesthetic|local anesthetic: 18-20 cc %0.5 lidocaine subcutaneous injection
15867196|NCT03904186|Behavioral|QUIT|QUIT is a transdiagnostic Cognitive Behavioral Therapy-based smoking cessation protocol designed to address distress intolerance, anxiety sensitivity, and anhedonia in people living with HIV who smoke. QUIT is delivered in 9 60-minute individual weekly sessions over a 10-week period. Sessions are active, with treatment components practiced within and outside of the session. Participants will also receive the transdermal nicotine patch for 8 weeks, starting when they attempt to quit smoking during week 7 of the study.
15867197|NCT03904186|Behavioral|Time-Matched Control (TM)|Participants will receive a standard smoking cessation treatment, based on the clinical practice guidelines from the U.S. Department of Health and Human Services, Treating Tobacco Use and Dependence. Treatment will be delivered in nine, 60-minute sessions over a ten-week period. The treatment is based on a treatment protocol developed and used previously by Dr. Zvolensky. Because clinical guidelines recommend that all smokers attempting to quit smoking receive pharmacotherapy, participants will also receive the transdermal nicotine patch for 8 weeks.
15867198|NCT03904173|Diagnostic Test|Multi-parameter tests|Prosigna Breast Cancer Prognostic Gene Signature Assay (PAM50) risk of recurrence (ROR) analysis CE marked assay termed Prosigna™ using digital bar code technology (NanoString Technologies Inc.).
15867199|NCT03904160|Behavioral|Weight management|Please see the arm descriptions.
15867200|NCT03904147|Device|Tricuspid valve repair|Transcatheter TriClip placement in the tricuspid valve to repair the valve and correct regurgitation
15867201|NCT03904134|Other|Donor Search Prognosis Score|Patients will be placed on a study arm after receiving a Donor Search Prognosis Score, which is based on HLA allele frequencies and race/ethnicity. This score predicts the likelihood of successfully identifying a 10/10 matched unrelated donor.Worse search prognosis is associated with racial and ethnic minority status but not with other patient and disease biology characteristics that might influence the success of hematopoietic cell transplantation (HCT). Thus, the use of donor search prognosis in this trial as a tool for biologic assignment to matched unrelated donors vs. mismatched donors provides a mechanism to minimize bias from disease characteristics.
15867202|NCT03904121|Procedure|Curative operation|Postoperative morbidity, mortality, functional outcome, survival
15867203|NCT03904108|Drug|Ramucirumab|platinum doublets chemotherapy plus ramucirumab, intravenously(IV)
15867204|NCT03904095|Procedure|Psoas Compartment Block Group (GROUP I)|Psoas Compartment Block will perform preoperative to all patients in Group I. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.
15867205|NCT03904095|Procedure|Erector Spinae Plane block ( Group II)|ESP Block will perform preoperative to all patients in ESP block group. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.
15867206|NCT03904095|Procedure|Control Group (GROUP III)|Control group will receive no intervention. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.
15867207|NCT03904082|Procedure|Erector Spinae Plane block ( Group ı)|ESP Block will perform preoperative to all patients in ESP block group. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.
15867208|NCT03904082|Procedure|Serratus Anterior Plane block ( Group ıı)|SAP Block will perform preoperative to all patients in SAP block group. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.
15867209|NCT03904082|Procedure|Control Group (GROUPIII)|Control group will receive no intervetion. Patients in all groups will provide with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.
15867210|NCT03904069|Drug|AMG 553|AMG 553 is a chimeric antigen T-cell receptor (CAR-T) therapy
15867211|NCT03904056|Procedure|ISQ-RP|"Patients were treated with single-spot targeted retinal photocoagulation directed toward areas of retinal nonperfusion detected by fluorescein angiography. In this group, laser treatment was performed in two sessions (week 0 and 2), with a shot duration of 100 ms, but spots were placed 1/2 burn apart and power modulated in order to generate moderately white spots on the retina.
~Retinal photocoagulation was performed with single-spot full-scatter PRP using Purepoint green diode laser (Alcon, Fortworth, Texas) with an Ocular Mainster PRP 165 lens with a dynamic field of view of 180 degrees, and a 200 micron spot size (which produces a 392 micron spot size on the retina). Intravitreal injection of 0.5 mg (0.05 ml) ranibizumab (Lucentis®) (IVR) were performed 180 minutes after the first laser session (week 0) by a single retina specialist."
15867212|NCT03904056|Procedure|ETDRS-PRP group|Panretinal photocoagulation (PRP) as described in ETDRS Study combined with intravitreal injection of ranibizumab
15867218|NCT03904030|Other|Rehabilitation with or without Anti-Gravity Treadmill|The study will include patients with grade III-IV primary knee osteoarthritis. The investigators will take 27 patients to the both groups. The investigators will look after more specifically the anti-gravity treadmill rehabilitation and traditional rehabilitation after arthroplasty. Follow-up is one year. Functional tests will be made and questionnaires will be given to the patients before operation and after operation. After 6 to 8 weeks, 4 months and 12 months of operation questionnaires will be fil up again. After six month the investigators will send a questionnaire and there will be asked possible rehabilitation sessions, use of drugs and possible complications after knee arthroplasty.
15867219|NCT03904017|Other|Oxygen|100% Oxygen air
15867220|NCT03904017|Other|placebo|medical air
15868321|NCT03895307|Other|local serum physiologic|serum physiologic : 18-20 cc % 0.09 NaCl subcutaneous injection
15867224|NCT03904004|Procedure|Laparoscopic Heller Myotomy|Five or six small incisions are made in the abdominal wall and laparoscopic instruments are inserted. The myotomy is a lengthwise cut along the oesophagus, starting above the lower oesophageal sphincter (LOS) and extending down onto the stomach a little way. The oesophagus is made of several layers, and the myotomy only cuts through the outside muscle layers which are squeezing it shut, leaving the inner mucosal layer intact.
15867225|NCT03903991|Other|Temperature recording|Tympanic and oesophageal temperatures will be recorded during the procedure
15867226|NCT03903978|Behavioral|Cognitive Behavioral Therapy|"The training protocol consists of 6 weekly modules:
~0.Welcome:Introduction module to the program, with an explanation about the tools and the way to use CORE
~Psychoeducation: Explanation of psychological wellbeing and the concept of resilience
~Autonomy, building my way: Enhancement of autonomy
~Mindfulness and self-compassion:Training in mindfulness, savoring, and an attitude of self-compassion
~Overcoming obstacles: Development of coping strategies to deal with daily difficulties in life
~Connecting to others:Acknowledge the relevance of relationships and how they can be helpful in the construction of well-being
~Purpose in life and personal growth:Approach the future with a positive attitude, planning goals for the future."
15867227|NCT03903978|Behavioral|Healthy lifestyle|"Beginning of a lifestyle change The patient will learn to identify healthy and risky behaviors and recognize obstacles that prevent them from adopting a healthy lifestyle.
~Physical activity The importance of moving on and activating behavior will be taught through regular exercise information to improve mood.
~Diet This module is dedicated to teaching the importance of diet for good physical and mental health. The Mediterranean diet will be taken as an example for a balanced and balanced diet, because it does not differ from the habits of other countries.
~Sleep The importance of good sleep will be addressed with information and strategies for understanding the relationship between sleep and overall health."
15867228|NCT03903952|Dietary Supplement|Vitamin B12 and folate|Vitamin B12 and folate levels in blood
15867229|NCT03903939|Drug|Iloprost|continuously infusion for 72 hours 1 ng/kg/min
15867230|NCT03903939|Drug|Isotonic saline|continuously infusion for 72 hours equal volume to Iloprost
15867231|NCT03903926|Biological|5000 volunteers (6-35 months)-EV71 vaccine|two doses EV71 vaccines will be administrated on day 0, 30 respectively
15867232|NCT03903913|Drug|S-1226|The drug product S-1226 has two components delivered by inhalation. It is a mixture of perfluorooctylbromide (PFOB) nebulized with a medical gas mixture containing CO2. The PFOB component remains the same but the medical gas component contains 4%, 8% or 12% CO2.
15867233|NCT03903900|Behavioral|Lifestyle-oriented Occupational Therapy added to current treatment of chronic non-malignant pain|The participants are recruited from the outpatient cohort admitted at The Multidisciplinary Pain Center (MPC) at Naestved Hospital (Zealand Region, Denmark). The participants receive both, the current treatment based on Cognitive Behavioural Therapy (CBT) and delivered by physicians, nurses, physical therapists and a social worker as usual care, and a lifestyle-oriented Occupational Therapy intervention. The Occupational Therapy intervention targets meaningful daily occupations, physical activity, and eating habits and routines. The intervention is delivered by graduated occupational therapists once á week during the 15 weeks after the initial 5-weeks compulsory psychoeducation course at the MPC. The intervention contains in-person contacts with OTs every other week (e.g. two 1-hour individual sessions at the hospital and/ or at-home and five 2-hours group sessions) and seven phone consultations in the opposite weeks.
15867234|NCT03903887|Biological|anti-PD1 antibody-activated TILs|Participants would receive one dose of anti-PD1 antibody-activated TILs at the final cycle of docetaxel and cisplatin (DP) regimen chemotherapy.
15867235|NCT03903874|Behavioral|Deep south Interactive voice response system supported Active Lifestyle (DIAL)|12 months of automated telephone physical activity counseling with community health worker support
15867236|NCT03903861|Other|Glucose alone|Young men or women will complete a glycogen depleting bout of exercise followed by the provision of glucose-alone over 4 hours of recovery before a subsequent bout of exercise.
15867237|NCT03903861|Other|Galactose alone|Young men or women will complete a glycogen depleting bout of exercise followed by the provision of galactose-alone over 4 hours of recovery before a subsequent bout of exercise.
15867238|NCT03903861|Other|Glucose and galactose|Young men or women will complete a glycogen depleting bout of exercise followed by the provision of glucose and galactose over 4 hours of recovery before a subsequent bout of exercise.
15867239|NCT03903848|Other|Exercise|Single session of treadmill walking and resistance exercise
15867240|NCT03903835|Drug|Enzalutamide Oral Capsule [Xtandi]|Detailed conditions for the use of the study treatments including dose and dosages are described in accordance with the marketing authorization in the SmPC (Summary of Product Characteristics).
15867241|NCT03903835|Drug|Abiraterone Oral Tablet [Zytiga]|Detailed conditions for the use of the study treatment including dose and dosages are described in accordance with the marketing authorisation in the SmPC.
15867242|NCT03903835|Drug|Carboplatin|Carboplatin will be administered every 3rd week with an AUC (area under curve) = 5 with a dose calculated according to the Carboplatin AUC Dose calculation (Calvert formula):Dose (mg) = TargetAUC (mg/ml x min) x [GFR ml/min + 25].
15867243|NCT03903835|Drug|Cabazitaxel 60 mg Solution for Injection|Detailed conditions for the use of the study treatment including dose and dosages are described in accordance with the marketing authorisation in the SmPC.
15867244|NCT03903835|Drug|Docetaxel Injectable Solution|Detailed conditions for the use of the study treatment including dose and dosages are described in accordance with the marketing authorisation in the SmPC.
15867245|NCT03903835|Drug|Radium Chloride Ra-223|Detailed conditions for the use of the study treatment including dose and dosages are described in accordance with the marketing authorisation in the SmPC.
15867246|NCT03903835|Drug|Niraparib plus Abiraterone acetate plus Prednisone|Niraparib and Abiraterone acetate will be provided by Janssen and will be provided either as a fixed dose combination or as single agents. Detailed use of the study treatment including dose and dosages are described in the Investigator's brochures and SmPC.
15867247|NCT03903822|Drug|PF-06700841|PF-06700841 topical cream
15867248|NCT03903822|Drug|Vehicle (Placebo)|Vehicle topical cream
15867249|NCT03903809|Drug|Pegol-Sihematide|Participants received Pegol-Sihematide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 10.0-12.0 grams per deciliter (g/dL).
15882783|NCT03783442|Drug|Placebo|Placebo to match Tislelizumab
15867250|NCT03903809|Drug|ESPO|Participants received ESPO by subcutaneous injection weekly. The starting dose was 6000 IU and was adjusted according to the instruction to maintain a hemoglobin target range of 10.0-12.0 grams per deciliter (g/dL).
15867251|NCT03903796|Drug|HS-10234|Drug: HS-10234 HS-10234 25mg will administer orally once daily Drug: TDF placebo TDF placebo 300mg will administer orally once daily
15867252|NCT03903796|Drug|TDF|Drug: TDF TDF 300mg will administer orally once daily Drug: HS-10234 placebo HS-10234 placebo 25mg will administer orally once daily
15867253|NCT03903783|Other|Cefotaxime|"Patients with C3G antibiotic therapy will receive cefotaxime. On the day of inclusion (T0, + 24 hours), a stool culture is performed on the first stool issued after the start of antibiotic therapy to detect BMR carriage and to evaluate the initial flora and fecal abundance initial relative in culturable multiresistant bacteria. In the absence of stool emission by the patient, an eswab rectal swab will be performed.
~72 hours (± 24 hours, T1) after the start of antibiotic therapy, a stool sample will be taken and at the end of antibiotic therapy (+ 24 hours, T2) or during the oral relay to evaluate the modification of the initial flora and the relative fecal abundance of culturable multiresistant bacteria. In the case of normal transit (daily bowel movement), the bowel movement 72 hours after the start of antibiotic therapy will be analyzed. In the absence of stool emission by the patient, an eswab rectal swab will be performed."
15867254|NCT03903783|Other|Ceftriaxone|"Patients with C3G antibiotic therapy will receive ceftriaxone. On the day of inclusion (T0, + 24 hours), a stool culture is performed on the first stool issued after the start of antibiotic therapy to detect BMR carriage and to evaluate the initial flora and fecal abundance initial relative in culturable multiresistant bacteria. In the absence of stool emission by the patient, an eswab rectal swab will be performed.
~72 hours (± 24 hours, T1) after the start of antibiotic therapy, a stool sample will be taken and at the end of antibiotic therapy (+ 24 hours, T2) or during the oral relay to evaluate the modification of the initial flora and the relative fecal abundance of culturable multiresistant bacteria. In the case of normal transit (daily bowel movement), the bowel movement 72 hours after the start of antibiotic therapy will be analyzed. In the absence of stool emission by the patient, an eswab rectal swab will be performed."
15867255|NCT03903770|Device|Upper extremity rehabilitation|Participants receive the SUPER intervention 3 times per week for 1 hr, during 4 weeks. For participants with a low recovery potential for hand function, the SUPER interventions consists in robot-assisted reaching movements and unilateral and bilateral VR activities. The robot-assisted activity consists of a reaching task to six targets placed at maximal reach distance. For the VR activity, we use a reach and grasp VR activity based on a shopping task. Participants with good potential for hand recovery also receive 30 min of electromyography-triggered muscle stimulation, combined with the VR activity. The muscle stimulation is triggered when the participant attempts to grasp a virtual object and helps with hand opening movements.
15867256|NCT03903757|Other|DNA methylome and total RNA sequencing|Epigenomics tools combined with bioinformatic analysis to correlate putative useful clinical biomarkers with clinical features
15867257|NCT03903744|Procedure|Cardioneuroablation|The electroanatomical map of the right (RA) and left (LA) atrium will be created and anatomically-based ablation of GP will be performed. Ablation in the RA is started from the supero-posterior area (superior right atrial GP), to the middle-posterior area (posterior right atrial GP). In the LA, ablation is started at the site of the anterior right GP and is continued downwards along the anterior part of a common vestibulum of the right pulmonary veins (PV), opposite to the right-sided ablation lesions. Finally, area of right inferior GP, close to the RIPV is ablated under intracardiac echocardiography control. Using this technique, GP's located close to the left PV are not ablated. We use a pure anatomic approach without identification of GP.
15867258|NCT03903731|Device|Total knee arthroplasty with Journey II BCS Total Knee System|Journey II BCS Total Knee System
15867259|NCT03903718|Drug|Oseltamivir|75 mg capsules orally twice a day from Day 2 to Day 7
15867260|NCT03903718|Biological|MEDI8852|MEDI8852 is a human IgG1 kappa monoclonal antibody administered as a single IV infusion at either dose 1 or dose 2 on Day 2.
15867261|NCT03903718|Drug|Placebo|Placebo is salt-water solution containing no active ingredients and administered as a single IV infusion on Day 2.
15867262|NCT03903705|Drug|Fruquintinib in Combination with Sintilimab|"Cohort A: Fruquintinib 3 mg QD, oral dosing, 3 weeks on/1 weeks off+Sintilimab 200mg Q4W, intravenous dosing.
~Cohort B: Fruquintinib 4 mg QD, oral dosing, 3 weeks on/1 weeks off+Sintilimab 200mg Q4W, intravenous dosing
~CohortC: Fruquintinib 5 mg QD, oral dosing, 2weeks on/1 weeks off+ Sintilimab 200mg Q3W, intravenous dosing
~CohortE: Fruquintinib 3 mg QD, continuous，oral dosing, + sinitilimab 200mg Q3W, intravenous dosing
~Patients will be treated until disease progression, death, unacceptable toxicity, loss of follow-up, withdrawal of consent or other conditions meet the end of treatment criteria."
15867263|NCT03903692|Device|Marine polysaccharide dressing|The MPS-Ag dressing used in this study has a unique gelling action which helps to remove dead, damaged, and infected tissues from the wound by trapping and removing them later at dressing changes. It is designed to provide intimate contact with the wound for gentle healing. It also contains ionic silver.
15867264|NCT03903692|Device|Carboxymethylcellulose dressing|The CMC-Ag dressing used in this study incorporates two technologies to help eliminate the key barriers to healing that are exudate, infection, and bioburden. It can be used on chronic and acute wounds that are infected or at risk of infection with varying exudate levels.
15867265|NCT03903679|Device|Laryngeal mask airway|Patients will be maintained with laryngeal mask airway during the septal surgery.
15867266|NCT03903679|Device|Endotracheal tube|Patients will be maintained with endotracheal tube during the septal surgery.
15867267|NCT03903666|Other|Nocturnal gaz exchanges measurement|Nocturnal gaz exchanges at patient's home BRIEF neuropsychological questionnaire VINELAND-II neuropsychological questionnaire Clinical OSA assessment Dysautonomia assessment
15867268|NCT03903653|Drug|Botulinum toxin type A|"Use of chemodenervation (botulinum toxin A) for treatment of lower extremity spasticity in ABI inpatients with regards to ankle range of motion.
~(a total of 350-400 units of botulinum toxin A per treated limb)"
15867269|NCT03903653|Device|Serial Casting|"Using Serial Casting in conjunction with Botox injection for treatment of lower extremity spasticity in ABI inpatients with regards to ankle range of motion.
~(a total of 350-400 units of botulinum toxin A per treated limb)"
15867270|NCT03903640|Device|Optune|-Optune is programmed by Novocure to deliver 200 kHz TTFields in two sequential, perpendicular field directions at a maximal intensity of 707mARMS.
15867271|NCT03903640|Biological|Nivolumab|-Standard of care
15867273|NCT03903627|Other|verbal instruction|Verbal instruction for pelvic floor contraction will be given to participants. Ultrasound examination will be conducted to asses urinary bladder displacement being a marker for pelvic floor muscle function.
15867274|NCT03903614|Behavioral|SML|SML consists of supervised handwriting practice, fitness exercises, and fine motor speed drills that preferentially belabor a participant's right eye, ear, hand and leg during therapy.
15867275|NCT03903614|Behavioral|CON|CON consists of supervised handwriting practice, fitness exercises, and fine motor speed drills on the participant's dominant hand.
15867276|NCT03903601|Diagnostic Test|Magnetic Resonance Imaging (MRI)|Magnetic Resonance Imaging (MRI) to diagnose ischemic changes in the brain.
15867277|NCT03903601|Diagnostic Test|Blood samples collection|Trimethylamine N-oxide (TMAO) concentration, oxidative stress markers and endothelial dysfunction markers will be determined in blood samples.
15867278|NCT03903601|Diagnostic Test|Neuropsychological tests|Cognitive functions assessment
15867279|NCT03903588|Device|Optical Coherence Tomography|Imaging of the Retina
15867280|NCT03903575|Procedure|En masse anterior teeth retraction|After extraction of the four premolars the posterior teeth will be tied-together and the six anterior teeth will be retracted by sliding mechanics.
15867281|NCT03903575|Procedure|Two-Step Retraction|After extraction of the four premolars the posterior teeth will be tied-together and the canines will be retracted by sliding mechanics. After the distalization of the canines they will be tied to the posterior teeth and the incisors will be retracted by sliding mechanics.
15867282|NCT03903562|Biological|V503|0.5 mL 9vHPV VLP Vaccine
15867283|NCT03903549|Drug|[18F]P17-059|Injection of < 10 mCi [18F]P17-059 followed by PET/CT scanning
15867284|NCT03903536|Procedure|Thrombectomy|A small procedure where surgeons make a cut in the hemorrhoid and drain the blood.
15867285|NCT03903536|Procedure|Hemorrhoidectomy|A surgery to remove the hemorrhoid, including the blood vessels and clot.
15867286|NCT03903523|Device|Lumen apposing metal stent (LAMS)|Stent positioning
15867287|NCT03903510|Device|Virtual Reality (VR)|Participants in the experimental group will receive an AppliedVR virtual reality headset during their cast removal.
15867288|NCT03903497|Device|NBI|optical assessment of diminutive colorectal polyps by NBI mode using the WASP assessment
15867289|NCT03903484|Other|Deprescribing toolbox and intervention|Pharmacist-led deprescribing plan with the patient which will include the patient's deprescribing goals. The intervention advocates for deprescribing according to recognized algorithms and guidelines which will be included in a resource toolbox/website.
15867290|NCT03903471|Device|22G-ProCore Endobronchial Ultrasound Needle|EchoTip Procore® Endobronchial HD Ultrasound Biopsy Needle, COOK
15867291|NCT03903471|Device|22G-Standard Endobronchial Ultrasound Needle|EchoTip® Ultra Endobronchial High Definition Ultrasound Needle, COOK
15867292|NCT03903458|Drug|Tinostamustine|First-in-human administration of the combination of Tinostamustine and Nivolumab.
15867293|NCT03903445|Behavioral|Masayang Pamilya Para Sa Batang Pilipino Program (MaPa Kids)|"MaPa Kids is an 8-session parenting program delivered weekly to groups of parents (N=15 per group).
~The program includes the following content: 1) spending one-on-one time with children; 2) describing actions and feelings for cognitive development and socio-emotional awareness; 3) using praise and rewards to encourage positive behavior; 4) establishing limits through effective instruction giving and consistent household rules; 5) nonviolent discipline such as ignoring negative attention seeking behavior, and consequences for noncompliance, rule-breaking, and aggressive behavior; 6) problem solving with children; and 7) mindfulness based stress reduction."
15867294|NCT03903445|Behavioral|Masayang Pamilya Para Sa Tinedyer Pilipino Program (MaPa Teens)|"MaPa Teens is a 9-session parenting program delivered to groups of parents and children aged 10-17 (N=15 dyads per group).
~The program includes the following content: 1) one-on-one time with parents and teens, 2) positive reinforcement of positive behavior, 3) managing anger and stress, 4) establishing rules and routines, 5) family budgeting, 6) accepting responsibility for actions, 7) resolving family conflicts, 8) keeping safe in the community and resolving conflicts, and 9) reflection and moving on."
15867295|NCT03903432|Other|MRI|candidates for ESS will be referred to conventional CT scans of the sinuses. If surgery is to be performed, the patients will sign an informed consent and be referred for a sinus MRI.
15867296|NCT03903419|Diagnostic Test|Feasibility study for the realization of 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT for identification of early recurrence in patients treated with radiotherapy for glioblastoma.|"This study is a non-randomized, prospective, feasibility study assessing 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT to differentiate early recurrence from post-radiation modifications in patients treated with radiotherapy for glioblastoma.
~Patients with a MRI performed since the end of the radiotherapy until 12 months of follow up after the end of radiotherapy, will be referred for both 68Ga-PSMA and 18F-FDOPA PET-CT, whatever the conclusion of the MRI (post radiation modifications, relapse or doubtful MRI)."
15867297|NCT03903406|Drug|ixazomib in combination with lenalidomide and dexamethasone|Patients with RRMM who have received at least one prior therapy will receive Ixazomib in combination with lenalidomide and dexamethasone within the routine clinical practice in accordance with prescription. Duration of therapy - until disease progression or unacceptable toxicity.
15867298|NCT03903380|Other|Manual Therapy and Usual care exercise protocol for neck pain|Manual Therapy protocol between four to eight sessions and exercise protocol will be progressively added to the intervention (from the fouth session of MT approximately).
15867299|NCT03903380|Other|Manual Therapy and Augmented reality exercise protocol|Manual Therapy protocol between four to eight sessions and Augmented reality exercise protocol will be progressively added to the intervention (from the fouth session of MT approximately).
15867300|NCT03903367|Drug|Fentanyl Citrate|standard GA and receive fentanyl infusion 2 mcg/kg/h after tracheal intubation and stopped at the end of the operation ,When HR or MBP increased ≥20% from base line readings, incremental dose of fentanyl will be given (2mcg /kg).
15867301|NCT03903354|Other|Incidence of infections within 7 days postoperatively|Measure blood glucose concentration intraoperatively and evaluate incidence of infections 7 days after surgery
15867302|NCT03903341|Other|fMRI|bold signal in visual pathway
15867303|NCT03903328|Other|Sarcopenia assessment|Sarcopenia assessment by measurement of Skeletal Muscle mass index, hand grip strength and usual gait speed for 5 meter distance, as per the guidelines of Asia Working group for Sarcopenia study, was carried out.
15867304|NCT03903315|Other|Comparison between patients with Patients with central malignant airway obstructions undergoing medical treatment alone versus medical and endoscopic treatment|Comparison between patients with Patients with central malignant airway obstructions undergoing medical treatment alone versus medical and endoscopic treatment with reference to mortality and complications.
15867305|NCT03903302|Drug|CS1-Sodium Valproate|Single and multiple dose evaluation of CS1
15867306|NCT03903289|Procedure|Automated red cell exchange|Erythrocytapheresis is an automated red cell exchange procedure that removes blood that contains HbS from the patient while simultaneously replacing that same volume with packed red cells free of HbS.
15867307|NCT03903289|Procedure|Manual red cell exchange|Active Comparator: Manual red cell exchange
15867308|NCT03903289|Procedure|Simple red cell transfusion|Active Comparator: Simple red cell transfusion
15867309|NCT03903276|Other|rehabilitation|Tens
15867310|NCT03903263|Diagnostic Test|survey on sleep disorders|self-administered patient questionnaire regarding the different aspects of sleep disorders in patients with dermatologic diseases
15867311|NCT03903250|Dietary Supplement|A-GPC|Taken orally in liquid form
15867312|NCT03903250|Dietary Supplement|Sugar|Taken orally in liquid form
15867313|NCT03903237|Other|retrospective chart review|retrospective report review of HZ patients treated between 2005 and 2018 in the Department of Dermatology at the University Hospital Basel
15867314|NCT03903224|Procedure|Combined Modified Pectoralis and Transversus Plane Blocks|"Modified pectoralis nerve block (Pecs II) aims to block at least the pectoral nerves, the intercostobrachial, intercostals III-IV-V-VI. This will cover dermatomes T2, T3 and T4. The probe is positioned under the lateral third of the clavicle .After locating the subclavian muscle, the axillary artery and the axillary vein we move the probe distally towards the axilla, until the pectoralis minor is identified. We start counting the ribs , from r1 under the axillary artery, we move distally and laterally until the lateral border of pectoralis minor is reached. The serratus anterior muscle which covers r2, r3, r4 is the point of entrance into the axilla.
~Blocking of multiple anterior branches of intercostal nerves (Th2-6) using a transversus thoracic muscle plane (TTP) block is used as an additive to pecs II to cover the internal mammary region"
15867315|NCT03903224|Procedure|Erector Spinae block|The patient is placed in a sitting position and The T5 spinous process is located by palpating and counting down from the C7 spinous process. Under complete aseptic conditions a linear ultrasound probe is then placed in a transverse orientation at the level of the T5 transverse process. The tip of the transverse process is centred on the ultrasound screen and the probe is then rotated into a longitudinal orientation to produce a parasagittal view. From T1 to T5 the erector spinae, rhomboid major and trapezius muscles are visible posterior and superficial to the transverse processes.
15867316|NCT03903211|Drug|[18F]PI-2620|Imaging for evaluating the accumulation of abnormal tau protein in the brain
15867317|NCT03903185|Drug|Ledipasvir / Sofosbuvir Oral Product|45 mg of ledipasvir and 200 mg of sofosbuvir orally, once daily with food
15867318|NCT03903172|Device|Abdominal binder|Abdominal binder
15867319|NCT03903159|Behavioral|Positive Peer Journaling (PPJ)|"PPJ is a journaling practice to support addiction recovery. PPJ encourages past 24 hour review and upcoming 24 hour planning to improve quality of life in recovery and reduce relapse. PPJ uses standard lined journals with column headings under which individuals make bullet-pointed lists. On the left hand page, past 24 hours is recalled, itemizing good and bad things that happened and things for which one is grateful. Wishes for others are also expressed on this page. On the right hand page, values-based activities for the upcoming 24 hours are planned via headings representing valued life domains such as recovery, work/school, spirituality, home and household, and health."
15867320|NCT03903146|Behavioral|Early Childhood Obesity Risk-Reduction Program in Hispanics|"Sessions Prenatal (40 min): Includes a colorful binder with information about breastfeeding. Set her goals and action plan for breastfeeding. Past experiences with breastfeeding. Benefits of adopting a healthy behavior, describe and discuss infant feeding and qualms about mixed feeding, barriers to EBF and self-efficacy.
~Prenatal Calls (10 min.): Discuss strategies available to accomplish mother's breastfeeding goals. Answer questions. Follow-up call until delivery.
~Hospital visit (30 min.): PC visit mother at the hospital stay to support the participant in her effort to breastfeeding.
~Postpartum home-visit (40 min.) IBCLC performs a home visit to assess infant feeding pattern, breastfeeding techniques with hands-on assistance if needed. Provide supplemental breastfeeding devices as needed. Answer all questions.
~Postpartum calls (10 min.): PC/IBCLC ask about problems/concerns and answer questions. Repeat phone calls as needed (at least 1 a month)."
15867321|NCT03903133|Drug|Vitamin E|vitamin E supplementation for three months (400-600 mg/day) (400 mg/day in those weighed less than 20 kg and 600 mg/day in those weighed at least 20 kg)
15867322|NCT03903120|Behavioral|ASSIST|"Integral stimulation based treatment (watch me, listen to me, say what I say) for CAS that is based on principles of motor learning and neuroplasticity and includes a systematic approach to adaptive practice. Treatment includes a focus on prosody, use of visual, tactile, auditory cues, slowing speech rate, and large amounts of practice."
15867323|NCT03903107|Procedure|Conventional fluoroscopy guided HBP|conventional standard approach his bundle pacing using fluoroscopy
15867324|NCT03903107|Procedure|Electroanatomic Mapping (fluoroless) guided HBP|his bundle pacing using electroanatomic mapping system with no or minimal fluoroscopy
15867326|NCT03903081|Drug|HEC110114 tablet|administered orally once daily
15867327|NCT03903081|Drug|Placebo Oral Tablet|Placebo will be administered orally at a dose and frequency matched to HEC110114
15867328|NCT03903068|Device|NEXALIN ADI AC stimulator|When the patient is ready for the treatment, place an electrode on the patient's forehead and place an electrode in each of the mastoid areas behind each ear. The three electrodes are placed in this way to enhance the performance of the Nexalin ADI device. When the device is activated, there will be a weak current passing through the forehead electrode and each mastoid electrode. The current intensity of Nexalin ADI treatment defaults to 15.00 mA and the duration defaults to 40 minutes. Both are preset to default parameters and cannot be changed.
15867405|NCT03902470|Procedure|Thoracic epidural anaesthesia video assisted thoracoscopic surgery|Patients in (TEA) group will pre-medicated using midazolam 3-4 mg (IV)and fentanyl 50 mcg (IV). Then An epidural catheter will be inserted between T3-T4 and T4-T5 . A test dose (5 ml) of 2% lidocaine will be given, followed by 15-20 ml of bupivacain 0.5%.
15867329|NCT03903068|Device|Pseudo-stimulator|When the patient is ready for the treatment, place an electrode on the patient's forehead and place an electrode in each of the mastoid areas behind each ear. When the device is started, no current flows through the electrodes, but the instrument's operating procedures, parameter displays, and prompts are the same as for a real instrument.
15867330|NCT03903055|Diagnostic Test|MDS group|patients diagnosed as MDS with high risk，aged 18-80，men/wemen
15867331|NCT03903029|Drug|Low-dose (10mg) rosuvastatin|Low-dose (10mg) rosuvastatin in 4 statin benefit groups per 2013 ACC/AHA guideline
15867332|NCT03903016|Drug|Insulin Lispro SAR342434|Pharmaceutical form:solution for injection Route of administration: subcutaneous
15867333|NCT03903016|Drug|Insulin Lispro SAR342434|Pharmaceutical form:solution for injection Route of administration: subcutaneous
15867334|NCT03903003|Device|high flow nasal oxygen device (POİNT)|With POINT device (peri-operative insufflatory nasal therapy); patients are heated at higher flow and applied to humidified oxygen.
15867335|NCT03903003|Device|Face mask|In order to protect the mother from hypoxia, preoxygenation is performed with face mask before induction of anesthesia.
15867336|NCT03902990|Other|Dual task|The patients in the dual task group received cognitive tasks during treadmill training sessions.
15867337|NCT03902990|Other|Treadmill Training|Standard treadmill training
15867338|NCT03902990|Other|Standard exercise programme|Standard exercise programme for Parkinson Disease
15867339|NCT03902977|Procedure|quilting|After mastectomies or ALND dissections using standard technique for wound closure multiple sutures (monocryl 3.0) every 3 to 4 cm in the site of the mastectomy (1 or 2 rows) or in the dissected axilla.Placement of one drain into the breast and axilla or in the axillary cavity by a separate stab incision
15867340|NCT03902977|Procedure|conventional suture|After mastectomies or ALND dissections standard technique for wound closure. Placement of one drain into the breast and axilla or in the axillary cavity by a separate stab incision
15867341|NCT03902951|Drug|Abiraterone Acetate|Given PO
15867342|NCT03902951|Drug|Apalutamide|Given PO
15867343|NCT03902951|Drug|Leuprolide Acetate|Given SC
15867344|NCT03902951|Other|Quality-of-Life Assessment|Ancillary studies
15867345|NCT03902951|Other|Questionnaire Administration|Ancillary studies
15867346|NCT03902951|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15867347|NCT03902938|Biological|Biodesign Otologic graft|Patient's mastoid cavity will be covered with porcine small intestine submucosa, Biodesign.
15867348|NCT03902938|Other|Autograft temporalis fascia|Patient's mastoid cavity will be covered with covered with autograft.
15867349|NCT03902925|Procedure|Topical lidocaine 2% jelly plus sub-tenon ropivacaine 10% injection|Lidocaine 2% jelly applied to conjunctival fornices for 5 minutes then injection of 2-4 ml of ropivacaine 10% in the sub-tenon space with a blunt cannula through a temporal inferior incision
15867350|NCT03902925|Procedure|Peribulbar injection|Peribulbar injection of 4-6 ml of ropivacaine 10%
15867351|NCT03902912|Drug|Prednisolone|prednisolone oral 10 mg/day from day one of the subsequent menstrual cycle to day LH 7 of that cycle. Then, the participants will be given a tailing off dose of 5 mg/day for 3 days followed by 2 mg/day for 3 days and then 1 mg/day for 3 days.
15867352|NCT03902899|Other|Educational intervention (oral presentation)|A brief oral presentation (30-45 minutes) which focused on making endoscopists aware of the significance and characteristics of serrated polyps.
15867353|NCT03902886|Diagnostic Test|gait analysis|gait analysis using an optoelectronic system and a surface EMG
15867354|NCT03902873|Other|Real-time audiovisual feedback|During the chest compressions, doctors receive audiovisual feedback on the depth and speed of the appropriate chest compressions.
15867355|NCT03902847|Behavioral|motor imagery|All subjects had to imagine that he/she was performing each exercise during 1 set of 12 repetitions prior to the real execution of this. During the second phase (the second and third week), subjects had to complete the set both imagining, with visual mental motor imagery, and actively performing the exercises.
15867356|NCT03902847|Behavioral|Action observation|A video was shown in third-person perspective. All subjects watched one person performing each exercise during 1 set of 12 repetitions. During the second phase (the second and third week), subjects had to perform actively the exercises while they watched the video.
15867357|NCT03902847|Behavioral|Motor Control Exercises|The subjects were asked to perform 3 sets, of 10-12 repetitions each six exercise, with a total duration of approximately 30-35 minutes. The exercises program had to do it once a day, 6 days a week, for 3 weeks.
15867358|NCT03902834|Other|Fitbit|Use the wearable technology (Fitbit) and proven behavioural change techniques to precondition patients prior to lung cancer surgery
15867359|NCT03902821|Other|XR-NTX and Certified Recovery Mentor|All consented participants will be offered an injection of extended-release naltrexone 3-7 days prior to release from prison. All consented participants will also be introduced to Certified Recovery Mentors one month prior to release.
15867360|NCT03902795|Diagnostic Test|Microperimetry|Microperimetry is a procedure to assess retinal sensitivity while fundus is directly examined; it enables exact correlation between macular pathology and corresponding functional abnormality.
15867361|NCT03902795|Diagnostic Test|M-charts|The M-chart (Inami Co., Tokyo, Japan) is a diagnostic tool developed by Matsumoto to quantify the degree of metamorphopsia in patients with macular diseases.
15867362|NCT03902782|Procedure|ESP block|"ESP with 20 ml of Bupivacaine 0.25%, Epinephrine 5mcg/ml and Dexamethasone 10mg.
~Sham intercostal block with 20 ml Normal Saline"
15867363|NCT03902782|Procedure|Intercostal block|"Intercostal block with 20 ml of Bupivacaine 0.25%, Epinephrine 5mcg/ml and Dexamethasone 10mg.
~Sham ESP with 20 ml Normal Saline"
15867364|NCT03902782|Procedure|Sham ESP block|As described earlier
15867365|NCT03902782|Procedure|Sham Intercostal block|As described earlier
15867366|NCT03902782|Drug|Bupivacaine-epinephrine|As described earlier
15867367|NCT03902782|Drug|Dexamethasone injection|As described earlier
15867368|NCT03902782|Drug|Normal saline|As described earlier
15867369|NCT03902769|Procedure|Prescribing conventional chemotherapy while with holding allo-SCT|Prescribing conventional chemotherapy (chemotherapy consolidations or autologous SCT) while with holding allo-SCT
15867370|NCT03902756|Other|Endotracheal cuff inflation|Endotracheal cuff inflation is putting the air in to the endotracheal tube cuff to make the proper sealing.
15867371|NCT03902743|Other|Anticipatory Care Plan group|The Anticipatory Care Plan will be delivered by a trained nurse. At the initial visit, the nurse will conduct a hollistic assessment using the EasyCare Assessment Tool. Following this visit, the nurse will draft a strucutred summary report of the home visit to include patient goals, preferences for care, identified problems and action list. The nurse will then consult with a pharmacist to identify any potential inappropriate prescribing. The nurse will then meet with the participants GP and review and provide feedback. The nurse will then re visit participants and discuss the report and agree a support plan and actions for follow up.
15867372|NCT03902730|Other|Traditional Back Squat|Participants will complete traditional back squat in this four treatment crossover design.
15867373|NCT03902730|Other|Barefoot Back Squat|Participants will complete barefoot back squat in this four treatment crossover design.
15867374|NCT03902730|Other|Box Squat|Participants will complete box squat in this four treatment crossover design.
15867375|NCT03902730|Other|Traditional Back Squat with Chains|Participants will complete traditional back squat with chains in this four treatment crossover design.
15867376|NCT03902717|Procedure|Minimally invasive cardiac surgery|Patients will undergo minimally invasive cardiac surgery
15867377|NCT03902704|Device|Cleverscope|the device is used in patients without difficult airways predictors
15867378|NCT03902704|Device|Laryngoscope / Videolaryngoscope C-MAC® Storz|the device is used in patients with difficult airways predictors
15867379|NCT03902691|Drug|Pegol-Sihematide|Participants received Pegol-Sihematide by subcutaneous injection once every 4 weeks ; the dose was adjusted throughout the study to maintain a hemoglobin target range of 10.0-12.0 grams per deciliter (g/dL).
15867380|NCT03902691|Drug|ESPO|Participants received ESPO by subcutaneous injection or subcutaneous injection weekly. The dose was adjusted throughout the study to maintain a hemoglobin target range of 10.0-12.0 g/dL.
15867381|NCT03902678|Procedure|EUS guided fine needle aspiration of portal vein thrombus|endoscopic ultrasound guided fine needle aspiration of portal vein thrombus which did not fulfill criteria of malignancy by imaging technique
15867382|NCT03902665|Drug|Up-front allogeneic hematopoietic stem cell transplantation (HSCT)|"Patients classified as fit/unfit are included in the HSCT program. There are two early approaches allowed. A) Patients will be left untreated until HSCT B) Patients will receive 1 short course of chemotherapy before HSCT (Ara-C and anthracycline).
~Selection of strategy A or B, will be patient based on disease characteristics and dynamics or presence of high tumor load.
~Conditioning for haplo-HSCT should be started as soon as possible, within day 45 after initial diagnosis. This is to avoid delayed transplantation. Two dosing levels of the Thiotepa-Busulfan-Fludarabine (TBF) based protocol are allowed based on the clinical condition of the patient: fit patients below 70 will receive the TBF with 2 days of Busulfan, whereas patients with poorer clinical condition or above the age of 70 will receive a dose-reduced TBF, in which Busulfan may be reduced to 1 day only."
15867383|NCT03902652|Procedure|Intervention (21% oxygen during CC+SI)|"Infants randomized into the 21% oxygen CC+SI group will receive a SI with a PIP of 25-30 cmH2O while receiving chest compression.
~The SI will be delivered over a period of 20 seconds. This will be followed by PEEP of 5-8 cm water fro 1sec. The use of 20sec SI will be repeated 3 times, which results to 60sec of chest compression. At that time the clinical team will perform an assessment of the newborn's heart rate.
~If heart rate is >60/min continue with standard care as per local hospital policy (standard hospital practice guideline). If heart rate remains <60/min continue with CC+SI for another 20sec at which time a further assessment should be performed. If heart rate remains <60/min continue with CC+SI.
~During CC+SI the clinical team will only use 21% oxygen."
15867384|NCT03902652|Procedure|Intervention (100% oxygen during CC+SI)|"Infants randomized into the 100% oxygen CC+SI group will receive a SI with a PIP of 25-30 cmH2O while receiving chest compression.
~The SI will be delivered over a period of 20 seconds. This will be followed by PEEP of 5-8 cm water fro 1sec. The use of 20sec SI will be repeated 3 times, which results to 60sec of chest compression. At that time the clinical team will perform an assessment of the newborn's heart rate.
~If heart rate is >60/min continue with standard care as per local hospital policy (standard hospital practice guideline). If heart rate remains <60/min continue with CC+SI for another 20sec at which time a further assessment should be performed. If heart rate remains <60/min continue with CC+SI.
~During CC+SI the clinical team will only use 100% oxygen."
15867385|NCT03902626|Other|Physiotherapy students|
15867386|NCT03902626|Other|Medical students|
15867387|NCT03902613|Drug|Lurasidone|Participant will have an open label trial of lurasidone for eight weeks.
15867388|NCT03902600|Radiation|Moderately Hypofractionated RT|Patients will be treated with moderately hypofractionated radiation treatment
15867389|NCT03902587|Device|Samsung's E-cervix technology|While patients are having their routine cervical ultrasound assessments which requires a 5 minute time period, we will use the built-in software to obtain additional E-cervix measurements to evaluate the consistency of the cervical os. This will be done within the standard 5 minute period which is typically done to observe for dynamic changes. The measurements will be obtained with the same sonogram machine, using updated software.
15867390|NCT03902574|Drug|Brexpiprazole ODT 2mg with water|Brexpiprazole ODT 2mg is administered with water.
15867391|NCT03902574|Drug|Brexpiprazole ODT 2mg without water|Brexpiprazole ODT 2mg is administered without water.
15867392|NCT03902574|Drug|Brexpiprazole conventional tablet 2mg|Brexpiprazole conventional tablet 2mg is administered with water.
15867393|NCT03902561|Device|one time colonoscopy in inpatients|All the inpatients with indication of colonoscopy will be prepared with 4 liters polyethylene glycol bowel cleansing prior to colonoscopy. Colonoscopy will be performed as regular practice under conscious sedation.
15867394|NCT03902548|Drug|[18F]P16-129|Injection of < 10 mCi [18F]P16-129 followed by PET/CT scanning
15867395|NCT03902535|Other|Comprehensive Geriatric Assessment|Complete comprehensive geriatric assessment
15867396|NCT03902535|Other|Quality-of-Life Assessment|Complete quality of life assessment
15867397|NCT03902535|Other|Questionnaire Administration|Complete questionnaires
15867398|NCT03902522|Drug|PRO 140|2 injections of PRO 140 (2 X 2 mL/inj.)
15867399|NCT03902509|Drug|Pirfenidone|pirfenidone capsule made in China
15867400|NCT03902509|Drug|basic treatment|glucocorticoid and expectant treatment etc.
15867401|NCT03902496|Other|HIT-6 Questionnaire|Headache Impact Test
15867402|NCT03902496|Device|Avulux Spectacles|Avulux™ Optical Filter in the Form of Spectacle Lenses
15867406|NCT03902457|Procedure|Maxillary sinus augmentation|Maxillary sinus augmentation procedures have become increasingly popular procedures before placement of dental implants in posterior maxillae that have suffered severe bone loss due to sinus pneumatization, alveolar bone atrophy, or trauma.
15867407|NCT03902444|Device|Credo® Stent, NeuroSpeed® PTA balloon catheter|a self-expanding stent is used together with a PTA balloon catheter
15867408|NCT03902431|Behavioral|ABCS training|Clinicians and patients will be given information regarding the ABCS (Aspirin, Blood Pressure control,Cholesterol control, and Smoking Cessation) and for reducing CVD risk among HIV patients.
15867409|NCT03902418|Drug|emtricitabine/tenofovir|Women recruited at ante-natal clinics, counseled about PrEP, and provided medication and follow up if desired
15867410|NCT03902405|Behavioral|Active CEASAR Intervention|Healthy and stimulant-use related pictures will be presented on a computer screen. Using a joystick, participants will be trained to pull in pictures that are presented in portrait orientation, and push those presented horizontally. In the active experimental condition, pushed pictures will exclusively be stimulant-related pictures.
15867411|NCT03902405|Behavioral|Placebo CEASAR|In the control condition, stimulant cues and healthy cues will be randomized and stimulant use-related pictures will be equally divided into push and pull conditions.
15867412|NCT03902392|Dietary Supplement|NaturOx Group (A)|Comparison between dietary supplement and placebo
15867413|NCT03902392|Other|Placebo Group (B)|Comparison between dietary supplement and placebo
15867414|NCT03902379|Other|Internet-Based Intervention|Receive CCI intervention
15867415|NCT03902379|Other|Quality-of-Life Assessment|Ancillary studies
15867416|NCT03902379|Other|Questionnaire Administration|Ancillary studies
15867417|NCT03902379|Other|Survey Administration|Ancillary studies
15867418|NCT03902366|Diagnostic Test|Neuropsychological assessment|Clinical research staff will complete a standardized neuropsychiatric study visit protocol with eligible participants who provide informed consent. The protocol will be conducted twice for each participant (baseline and 6 months later).
15867419|NCT03902366|Behavioral|Neuroimaging|Subjects, well characterized with respect to their substance use, will be evaluated with fMRI tasks, rsMRI, high resolution anatomical MRI, standard DWI and high angular resolution diffusion imaging (HARDI) at baseline and 6 months later.
15867420|NCT03902353|Other|Screening of adult without diagnosis of PH carrying an heterozygous EIF2AK4 mutation.|will be performed : a clinical evaluation (dyspnea assessed by New York Heart Association functional class (I-IV), signs of right heart failure), a 6min walk test, a Computerized Tomography scan of the chest, an electrocardiogram, an echocardiography (measurement of the velocity of tricuspid regurgitation, measurement of Tricuspid Annular Plane Systolic Excursion (TAPSE) and Tei index, pericardial effusion, dilatation and hypertrophy of the right ventricle), an abdomina ulstrasound, a stress Test (ventilation oxygen peak and ventilation oxygen specific, minute ventilation, dead-space ventilation / dead space, ventilatory reserve, alveolar-arterial gradient, pulse oxygen, PaO2), a lung function tests and measurement of Diffusing capacity or transfer factor of the Lung for Carbon mOnoxide (DLCO) and Nitric Oxide (DLNO), and a blood sample.
15867421|NCT03902340|Device|ActiTENS|ActiTENS is a rechargeable box, weighing 64g attached by Velcro to an adhesive support, which can be positioned on the skin at any position chosen by the patient. The patient will use the programme (P4) prescribed by his doctor and will regulate the intensity of stimulation using an application downloaded to his smartphone which will communicate with the box via Bluetooth.
15867422|NCT03902340|Drug|Level 2 Analgesic Treatments|"There are 4 level 2 oral analgesic treatments indicated for chronic nociceptive pain of moderate to severe intensity (between 4 and 7 on a simple numerical scale of 11 points) (12):
~Tramadol immediate release formulation (IR, one intake every 6 hours) or prolonged release formulation (PR, one intake every 12 hours); maximum posology 400mg/24h.
~Dihydrocodeine: 60mg every 12 hours; maximum posology 120mg/24h.
~Combination of paracetamol and codeine in a fixed combination every 6 hours; maximum posology of codeine: 300mg/24h.
~Combination of paracetamol and tramadol in a fixed combination; maximum posology of tramadol: 8 tablets/24h ie 300mg/24h."
15867423|NCT03902327|Dietary Supplement|NAC group|Nutrition intervention focused on the treatment of carbohydrate metabolism disorder + N - acetylocysteine supplementation (1600 mg /d, 400 mg x 4 times a day)(30 people).
15867424|NCT03902327|Dietary Supplement|Control group|Nutrition intervention focused on the treatment of carbohydrate metabolism disorder + placebo (4 times a day) (30 people).
15867425|NCT03902314|Drug|Lidocaine Iv|Intravenous infusion
15867426|NCT03902314|Drug|Saline Solution|Intravenous infusion
15867427|NCT03902301|Dietary Supplement|Lactobacillus group|Nutrition intervention focused on the treatment of insulin resistance + Lactobacillus rhamnosus supplementation (6x10 9 of lactobacillus rhamnosus x 2 times a day) (35 people).
15867428|NCT03902301|Dietary Supplement|Dietary group|Nutritional intervention focused on the treatment of insulin resistance (35 subjects).
15867429|NCT03902288|Other|Fresh pomegranate juice|Pomegranate seeds (arils) were separated by hand, and fresh pomegranate juice was prepared by squeezing the seeds using a fruit squeezing machine. Fresh pomegranate juice was given at 1.5 mL/kg of body weight for the fasted recruited patient with type 2 diabetes (FSG < 15.8 mmol/L). Blood was collected before and after 1 and 3 hours of ingesting the juice.
15867430|NCT03902275|Other|Quantra-Algorithm|Hemotherapy based on Quantra-Algorithm
15867431|NCT03902275|Other|ROTEM-Algorithm|Hemotherapy based on Basic-Algorithm
15867432|NCT03902262|Procedure|appendicectomy|
15867433|NCT03902249|Drug|Dexamethasone|
15867434|NCT03902236|Other|Reaction Time and Postural Control|Reaction Time and Postural Control: With ''Fitlight TrainerTM'', 6 light emitting diode (LED) lights placed at certain points on the wall are randomly lit and expected to deactivate them as fast as possible. In the protocol, the leds will be placed according to the physical structure of the person, and the scores of 29 LED's will be kept in seconds. The scores will be compared cystic fibrosis, bronchiectasis and healthy groups.
15867435|NCT03902236|Other|Muscle oxygenation|Muscle oxygenation will be assessed with wearable lactate threshold predicting device in cystic fibrosis, bronchiectasis and healthy groups.
15867471|NCT03901963|Drug|Daratumumab|Daratumumab 1800 mg will be administered by SC injection weekly during Cycles 1 and 2, every 2 weeks during Cycles 3 through 6, and every 4 weeks from Cycle 7 onward until confirmed progressive disease (PD), unacceptable toxicity, or until end of study treatment for a maximum of 36 cycles.
15867436|NCT03902236|Other|Exercise capacity|Exercise capacity will be assessed with incremental shuttle walk test in cystic fibrosis, bronchiectasis and healthy groups.The patient is required to walk around two cones set 9 metres apart (so the final track is 10 metres) in time to a set of auditory beeps played on a CD. Initially, the walking speed is very slow, but each minute the required walking speed progressively increases.The patient walks for as long as they can until they are either too breathless or can no longer keep up with the beeps, at which time the test ends The number of shuttles is recorded. Each shuttle represents a distance of ten metres
15867437|NCT03902236|Other|Balance|Balance will be assessed with functional reach test in cystic fibrosis, bronchiectasis and healthy groups Functional Reach measures the maximum distance a person can reach forward, the distance of the person standing at the edge of the wall with a 90-degree shoulder flexion and the maximum distance to the front of the thumb will be noted.
15867438|NCT03902223|Diagnostic Test|Enhanced Screening Protocol for Cardiac Sarcoidosis.|To utilize enhanced screening tests for cardiac sarcoidosis in an undiagnosed and potentially under-diagnosed patient population to determine the rate of missed cardiac sarcoidosis diagnosis. Following testing by the standard screening tests, this intervention includes a subsequent echocardiogram and a wearable ECG, also known as a Holter Monitor or ambulatory ECG.
15867439|NCT03902223|Diagnostic Test|Routine Screening for Suspected Cardiac Sarcoidosis|To utilize standard of care screening tests for cardiac sarcoidosis. This includes symptom check and a standard ECG.
15867440|NCT03902210|Behavioral|Online Yoga|60 minutes per week of online yoga through Udaya.com
15867441|NCT03902210|Behavioral|Podcast|60 minutes per week of podcasts
15867442|NCT03902197|Biological|CD19 hsCAR-T|CD19 hsCAR-T will be administered by I.V. infusion
15867443|NCT03902184|Biological|IPH4102|Patients will receive a flat dose of 750mg
15867444|NCT03902171|Device|Soberlink|Soberlink delivers real-time blood alcohol results to people who support individuals in recovery from alcohol use disorder. In-Home Addiction Treatment program Care Team monitors and responds to results as part of care to improve treatment outcomes.
15867445|NCT03902158|Device|Glasses|The patient will wear virtual reality glasses during anesthesia
15867446|NCT03902158|Behavioral|Distraction techniques|The patient will undergo distraction techniques
15867447|NCT03902145|Other|Egg|One egg per day for 6 months
15867448|NCT03902132|Other|Core Stability exercises group|Core Stability Exercises were given in addition to the traditional physical therapy treatment as given to the control group. It included moist heat pack (10mins), Transcutaneous Electrical Nerve Stimulation (10 min), and strengthening regimen (2 sets with 15 isometric repetitions each).
15867449|NCT03902132|Other|Traditional low back physical therapy group|The control group was given traditional low backache physical therapy management such as moist heat pack, TENS, and strengthening regimen (2 sets with 15 isometric repetitions each)
15867450|NCT03902119|Device|INYBI tool|Patients will lie down in supine position so that the INYBI tool will contact the suboccipital muscles at the posterior arch of the atlas. The therapist will adapt the height of the tool for each individual. All patients will use the softest head of the device. A 50Hz vibration speed will be set sup during 5 minutes.
15867451|NCT03902119|Other|Manual suboccipital inhibition|Patients will lie down in supine position.The therapist will be seated at the head of the treatment table. The therapist will keep the metacarpophalangeal joints in a flexed position, while therapists fingertips of both hands will contact with the suboccipital muscles at the posterior arch of the atlas.
15867452|NCT03902106|Drug|salbutamol|subjects ingest salbutamol
15867453|NCT03902106|Other|exercise|subjects undergo 6 weeks of endurance training (3 times weekly)
15867454|NCT03902093|Diagnostic Test|Morphology changes with extended wear hearing aid|Possible changes in morphology due to wearing an extended wear hearing aid device will be assessed with imaging
15867455|NCT03902080|Drug|Vibegron|oral administration
15867456|NCT03902080|Drug|Placebo|oral administration
15867457|NCT03902067|Biological|UC-MSC|0.25ml Shanghai Life UC-MSC injection is resuspended into 10ml of cell suspension and slowly infused into infarct-related blood vessels through an administration catheter in 2 minutes, and the number of cells transplanted each time is 5x10(6) cells. The UC-MSC products are manufactured by Shanghai Life with viability>80%, and endotoxin<0.1 EU， at the concentration of 2x10(7) cells/ml.
15867458|NCT03902067|Biological|Control Group|Routine treatment without catheter infusion
15867459|NCT03902054|Biological|Three-dose regimen of high dosage investigational sIPV|The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..
15867460|NCT03902054|Biological|Three-dose regimen of medium dosage investigational sIPV|The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..
15867461|NCT03902054|Biological|Three-dose regimen of low dosage investigational sIPV|The investigational vaccines were manufactured by Beijing Minhai Biotechnology Co. Ltd..
15867462|NCT03902054|Biological|Three-dose regimen of commercialized sIPV|The control vaccine was manufactured by Chinese Academy of Medical Sciences.
15867463|NCT03902054|Biological|Three-dose regimen of commercialized IPV|The control vaccine was manufactured by Sanofi Pasteur S.A (IMOVAX POLIO).
15867464|NCT03902041|Drug|Eltrombopag|The patients will receive Eltrombopag treatment after transplantation
15867465|NCT03902028|Other|Reinforced multidisciplinary follow-up|Reinforced multidisciplinary follow-up
15867466|NCT03902015|Device|Nuance Phone case|"participants will receive a phone (iPhone) with the Nuance Phone case and a designated app required for the use of the device. Participants will first undergo hearing test via the app, and afterwards (in case they are not excluded based on hearing status), will receive a introduction on how to use the app and the device. Before starting the clinical trial, children will undergo three adjustments days in which they will practice using the device in school. During this period the researchers will make sure that the participants are adapting to the use of the device, and in any case there is a problem, will be able to contact a representative of Nuance Hearing who will be available to support technical issues."
15867467|NCT03902002|Drug|Omaveloxolone 50 mg capsules|Capsules containing 50 mg of omaveloxolone
15867468|NCT03901989|Device|zeolite|given for a period of 12 months
15867469|NCT03901989|Device|cellulose|given for a period of 12 months
15867470|NCT03901976|Device|bed exit detection|bed exit detection to avoid patients fall
15868766|NCT03891862|Drug|Valbenazine|vesicular monoamine transporter 2 (VMAT2) inhibitor
15867472|NCT03901963|Drug|Lenalidomide|Lenalidomide 10 mg will be administered orally from Day 1 to Day 28 (continuously) of each 28-day cycle until confirmed PD, unacceptable toxicity, or until end of study treatment for a maximum of 36 cycles. After 3 cycles of maintenance therapy, if well tolerated, the lenalidomide dose may be increased to 15 mg daily, at the discretion of the investigator.
15867473|NCT03901950|Drug|XNW7201 tablets|A wnt pathway inhibitor
15867474|NCT03901937|Drug|ω-3 polyunsaturated fatty acid|CD patients are divided into two groups, which include with and without ω-3 polyunsaturated fatty acid-based PN (0.1-0.2g/kg/d).
15867475|NCT03901937|Procedure|Intestinal surgery for Crohn's Disease|Patients receive bowel resection due to complications of Crohn's Disease
15867476|NCT03901924|Other|Volume Support Mode Mechanical Ventilation|This is a spontaneous mode of mechanical ventilation that depends on the patient's efforts. A target volume (6 cc/kg of IBW), PEEP and FiO2 are set by the medical team, and the ventilator varies the inspiratory pressure support with each breath to achieve the target volume. The respiratory rate is fully dependent on the patient. Sedation while on mechanical ventilation will be set at a goal RASS of 0 to -2.
15867477|NCT03901924|Other|Assist Control Mode Mechanical Ventilation|This is a controlled mode of mechanical ventilation that is independent of patient's efforts. A tidal volume (6 cc/kg of IBW), respiratory rate, PEEP and FiO2 are set by the medical team. Sedation while on mechanical ventilation will be set at a goal RASS of 0 to -2.
15867478|NCT03901898|Behavioral|Training, audit, and reminders|Briefing and training for participating practices, baseline practice audit, addition of electronic prompts to patient records, GP-endorsed patient reminders (in person, phone and letter), and re-audit at 6 months.
15867479|NCT03901898|Behavioral|Intervention after 6 months (wait list)|After 6 months, practices receive the intervention: briefing and training for participating practices, baseline practice audit, addition of electronic prompts to patient records, GP-endorsed patient reminders (in person, phone and letter).
15867480|NCT03901885|Other|Female Sexual Function Index questionnaire|Assessment of FSFI (Female Sexual Function Index) questionnaires preoperatively and postoperatively (4 months).
15867481|NCT03901872|Device|Contemporary endovascular venous intervention by Zelante pharmacomechanical thrombolysis|All patients will undergo ultrasound guided micro puncture venous access of the enrolled ipsilateral lower extremity popliteal vein followed by a diagnostic venogram to define thrombus burden and anatomic extent of DVT. Prior to and every 30 minutes during the endovascular procedure, an activated clotting time (ACT) will be obtained. Intravenous unfractionated heparin will be administered to keep the ACT between 250 - 300. A Zelante catheter will be utilised to perform pharmacomechanical thrombolysis of the enrolled lower extremity. If there is involvement of the popliteal and/or femoral vein, pharmacomechanical thrombolysis should also be performed of these veins. Venous stenting may be implemented to address areas of residual venous stenosis or outflow obstruction following pharmacomechanical thrombolysis. Stent placement in the common iliac, external iliac, and common femoral vein are routinely done to address inflow or outflow issues after pharmacomechanical thrombolysis.
15867482|NCT03901846|Device|ColdZyme|ColdZyme is a Class I medical device (CE-marked) with the following composition: glycerol, water, Tris buffer, CaCl2, menthol and trypsin
15867483|NCT03901833|Behavioral|Telemedicine Support|Telemedicine intervention
15867484|NCT03901833|Other|Standard of Care|Standard of Care
15867485|NCT03901820|Device|Medication Interaction System of Dr App (SIMDA)|A module for the electronic clinical records allowing detection of the potential drug interactions
15867486|NCT03901807|Device|Toraymyxin PMX 20R Extracorporeal Hemoperfusion Cartridge|TORAYMYXIN PMX-20R (PMX) is an extracorporeal hemoperfusion cartridge intended for the selective removal of endotoxin from circulating blood through direct hemoperfusion (DHP). Each treatment will target 2 hours with a minimum of 1 ½ hours, at a flow rate of approximately 100 mL/minute, (range of 80 to 120 mL/minute).
15867487|NCT03901794|Device|Non-invasive hemodynamic monitor|MAP, HR, CO, SVI, from Non-invasive hemodynamic monitor
15867488|NCT03901781|Combination Product|ST266 via Intranasal Delivery|ST266 administered by non-invasive trans-cribriform intranasal delivery using the SipNose intranasal device.
15867489|NCT03901768|Drug|Dexamethasone|a syringe having 4ml of 4mg/ml of dexamethasone is used for intravenous injection.
15867490|NCT03901768|Drug|Triamcinolone|1ml of 40mg triamcinolone is mixed in the syringes containing solution for intrarticualar local infiltration. The solution is injected intraarticularly.
15867491|NCT03901768|Drug|Placebos|A syringe having 4ml of saline is used for intravenous injection. 1ml of saline is mixed in the syringes containing solution for intrarticualar local infiltration. The solution is injected intraarticularly.
15867492|NCT03901755|Drug|Alprolix|Extended half-life factor IX product
15867493|NCT03901742|Other|Protein-enriched nutrition|Protein-enriched enteral nutrition with a polymeric infant formula
15867494|NCT03901742|Dietary Supplement|High Protein-enriched Nutrition|High protein-enriched enteral nutrition with a polymeric infant formula plus a protein supplement
15867495|NCT03901742|Other|Standard Enteral Nutrition|Cow's milk based infant formula.
15867496|NCT03901729|Drug|BAY 1753011|Tablet; 30mg or 5mg unit; 30mg once daily in the morning; Oral
15867497|NCT03901729|Other|Placebo BAY 1753011|Tablet; Once daily in the morning; Oral
15867498|NCT03901729|Drug|Furosemide|Tablet; 40mg unit; 80mg once daily in the morning; Oral
15867499|NCT03901729|Other|Placebo Furosemide|Tablet; Once daily in the morning; Oral
15867500|NCT03901716|Drug|Sufentanil|Patients in Group S received sufentanil 0.1 mcg/kg.
15867501|NCT03901716|Drug|Fentanyl|Patients in Group F received fentanyl 1 mcg/kg.
15867502|NCT03901716|Drug|Remifentanil|Patients in Group R received remifentanil target-controlled infusion with effect-site target concentration of 1ng/ml.
15867503|NCT03901716|Drug|Midazolam|Patients in all groups received midazolam to achieve moderate levels of sedation as assessed by the Narcotrend (NT; between B1 and C2).
15867504|NCT03901703|Other|Physiotherapy and Rehabilitation|The children in each group will receive 6 weeks of functional strengthening exercises targeting each muscle group according to the arm they are included in.
15867505|NCT03901690|Drug|Betaglucin soluble gel 0.2%|With the prior informed consent of the 51 study participants, 5 grams of 0.2% soluble betaglucin gel will be self-applied every 12 hours for 5 days. Both groups will receive an unlabeled tube so that none of the study participants will know what topical treatments they are receiving.
15867506|NCT03901690|Drug|Imiquimod 5% cream|With the prior informed consent of the 51 study participants, 1 gram of 5% imiquimod will be self-applied once a day for 5 days. Both groups will receive an unlabeled tube so that neither study participant knows what topical treatments they are receiving.
15867507|NCT03901677|Other|Tai-chi training|Group exercise apply with physiotherapist
15867508|NCT03901651|Diagnostic Test|Colonoscopy with Retroview scope combing forward and retroflexed withdrawal technique|"Colonoscopy using a combined forward and retroflexed evaluation of the colonic mucosa. using the Retroview™ scope. The operator will be blind to the standard colonoscopy findings.
~The operator will record the polyps and adenoma encountered, describing the size and location."
15867509|NCT03901651|Diagnostic Test|Colonoscopy with standard colonoscope and forward withdrawal technique|"A standard colonoscopy with forwarding viewing withdrawal technique. An HD colonoscope with I-scan technology will be used by one expert endoscopist.
~Each polyp and adenoma will be recorded, including the size and location."
15867510|NCT03901638|Drug|Tllsh2910|Tllsh2910 80mg twice per day orally for 12 weeks
15867511|NCT03901638|Drug|Placebo|Placebo
15867512|NCT03901625|Device|Manual Toothbrush|A manual toothbrush is used to clean teeth surfaces.
15867513|NCT03901625|Device|Dental floss|A dental floss is used to clean inter-proximal areas.
15867514|NCT03901625|Device|Waterjet|A waterjet is used to clean inter-proximal areas.
15867515|NCT03901625|Device|Electric Toothbrush|An electric toothbrush is used to clean teeth surfaces.
15867516|NCT03901612|Drug|Ropivacaine 0.2%|Continuous post operative regional analgesia
15867517|NCT03901612|Drug|saline 09%|Continuous post operative regional analgesia
15867518|NCT03901599|Other|Alveolar ventilation monitoring estimated by the capnographic ventilation|Children are monitored using end-tidal CO2, Transcutaneous CO2 and volumetric capnographic. Respiratory rate is set using textbooks and guidelines (pediatric advanced life support). The physician in charge adapts the volume to target a CO2 between 38 and 42 mmHg. Data are recorded after a stabilization period of at least 5 minutes.
15867519|NCT03901586|Other|Satisfaction assessment|Patient will be asked to assess their satisfaction concerning the Richter procedure and its long term effect
15867520|NCT03901586|Other|Quality of life|The Quality of life will be assessed with 3 questionnaires (I-Qol / PISQ-12/PFDI-20)
15867521|NCT03901586|Other|Gynecological assessment|An optional gynecological consult is proposed to the patients to better estimate the gynecological long-term impact of the procedure
15867524|NCT03901560|Other|Music Therapy|
15867525|NCT03901547|Behavioral|Communication Skills Training|Education training in the serious illness communication guide (SICG) by Ariadne labs.
15867526|NCT03901547|Behavioral|Profile feedback|Providing participants their personal documentation rate of SICG in the electronic medical record
15867527|NCT03901547|Other|Maslach burnout inventory|Maslach burnout inventory
15867528|NCT03901547|Other|Emotion Regulation Skills Question (ERSQ)|This validated instrument consists of 27 items, and includes subscales related to nine competencies of coping with negative emotion (awareness, sensations, clarity, understanding, acceptance, tolerance, readiness to confront, compassionate self-support and modification) which can be summed to a total score (TOTAL). This validated instrument consists of 27 items, and includes subscales related to nine competencies of coping with negative emotion (awareness, sensations, clarity, understanding, acceptance, tolerance, readiness to confront, compassionate self-support and modification) which can be summed to a total score (TOTAL).
15867529|NCT03901547|Other|Semi-structured interview|Interviewer asked subjects are a series of questions based on interview guide. Current guide designed to assess subject perception of implementation of training in clinical encounters, most recent encounter with patient with serious illness, barriers to documentation and coaching by faculty on communication. Interviews will be recorded and expected duration is 20-40 minutes.
15867530|NCT03901547|Behavioral|Priming|"Participants will be provided a list of 30 patients they have encountered before that 1) have at least one documented note and 2) have a high probability for having serious illness as determined by electronic medical record screening. Participants will be asked 4 yes or no questions on each patient. Questions: 1) do you believe this patient has serious illness?; 2) would you be surprised if this patient died in the next year?; 3) would the patient benefit from the serious illness conversation guide? and 4) If you saw this patient again, would you use the serious illness conversation guide with him/ her?"
15867531|NCT03901534|Device|Auto-CPAP|Use of Auto-CPAP
15867532|NCT03901534|Other|Withdrawal of Auto-CPAP|Withdrawal of Auto-CPAP
15867533|NCT03901508|Device|TDCS|20 minutes, 2 electrodes (C3/FP2)
15867534|NCT03901495|Other|Diaana|"Diaana, the AMHTD used, functions as follows: on the basis of an interactive questionnaire completed by the patient before the consultation, it performs an exhaustive anamnesis focused on the problem and proposes a panel of DDs with a high sensitivity. The artificial reasoning system of Diaana mimics how a specialist physician would reason to establish a DD. The information transmitted is in an easy-to-use form for the physician that includes a summary of the anamnesis centered on relevant elements from the questionnaire and a list of possible diagnoses with their emergency level, potential contributing factors, and first-line management proposals."
15867535|NCT03901482|Drug|Dihydroergotamine|Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
15867536|NCT03901482|Drug|Placebos|Placebo for STS101
15867537|NCT03901469|Drug|ZEN003694|Bromodomain Inhibitor
15867538|NCT03901469|Drug|Talazoparib|PARP Inhibitor
15867565|NCT03901274|Behavioral|Clinical Services Support|The CSS framework packages together evidence-based practices of family engagement, modular evidence-based practice, quality assurance, and implementation support. Depending on their time of enrollment, participants can be involved in this condition for one to three years. They will be asked to complete assessments during their therapy sessions periodically throughout the trial.
15867776|NCT03899571|Drug|Oseltamivir Oral Capsule for 10 days post-exposure|Patients will receive oseltamivir for 10 days after last influenza exposure.
15867539|NCT03901456|Behavioral|Care to Plan|Care to Plan (CtP) is an online care planning tool that provides a succinct and clear overview of various types of ADRD caregiver interventions, administers a brief validated assessment of risk, and generates individualized service recommendations for Alzheimer's disease and related dementia (ADRD) caregivers as well as resources that link users to a selected recommendation. Caregivers will complete the tool with the guidance of a CtP interventionist (Senior Care Navigator/Riverside Health System staff). The interventionist will discuss CtP recommendations with caregivers and help caregivers enroll in a recommended support service if so desired.
15867540|NCT03901456|Behavioral|Usual Care|"Receive care as usual.
~Note: If eligible, participants in this control group will be asked if they are interested in enrolling in a similar, additional feature of the study to test the Care to Plan tool following the initial 6-month study."
15867541|NCT03901443|Other|Survey on itch|self-administered patient questionnaire regarding the different aspects of itch
15867542|NCT03901430|Behavioral|Group navigation model|In a series of peer group sessions facilitated by Guadalupe Fuentes, a CHW who designed the model, we will create a culturally-appropriate, non-stigmatizing group intervention. The group process will allow participants to explore their own MEH, better understand the ways that mental health influences well-being and everyday dynamics of their lives, and to develop empowering knowledge and action plans through the support of other women.
15867543|NCT03901417|Device|Fraxel Restore (Non-ablative Fractional Laser)|In the study, one side of the face will be treated with non-ablative fractional laser monthly for three months.
15867544|NCT03901417|Device|Fraxel Restore (Non-ablative fractional laser) and SkinPen (Microneedling Device)|In the study, one side of the face will be treated with a combination of non-ablative fractional laser and microneedling monthly for three months.
15867545|NCT03901404|Procedure|Myomectomy Operation|Patients undergoing myomectomy for myoma uteri
15867546|NCT03901391|Diagnostic Test|Whole Exome Sequencing|Whole Exome Sequencing
15867547|NCT03901378|Drug|Pembrolizumab|Intravenous administration of pembrolizumab in combination with cisplatin or carboplatin and etoposide in first line metastatic or unresectable high grade neuroendocrine carcinoma:
15867548|NCT03901365|Other|Neuroscience pain education|In Neuroscience pain education (NPE) sessions, patients were informed about the pain experience and the neurophysiological process about pain. NPE was performed by the method proposed by Louw et al (12). NPE was administered 4 sessions per week for four weeks. Trainings were conducted in the form of face-to-face interview and 45-50 minutes of one-to-one sessions.
15867549|NCT03901365|Other|Traditional patient education|In traditional patient education (TPE) sessions were aimed to explain to patients a proposed treatment or efficacy of a certain manual therapy technique or approach, have focused heavily on biomechanical and anatomical models. These models would imply that injury, disease, and muscle guarding may lead to altered movement patterns, asymmetrical loading, and resultant pain and dysfunction. TPE was administered 4 sessions per week for four weeks. Trainings were conducted in the form of face-to-face interview and 45-50 minutes of one-to-one sessions.
15867550|NCT03901365|Other|Manual therapy|Manual therapy (MT) was individualized according to each patient's response to treatment. In this method, the physiotherapist identifies and performs techniques suitable for the patient's symptoms. If the selected techniques do not have a direct positive effect on the patient's symptoms, they are replaced with other techniques.MT were performed in a total of 8 sessions, held twice a week for 4 weeks. Treatment sessions lasted an average of 40-45 minute.The entire treatment program was carried out by the same physiotherapist who is trained and experienced in this area.
15867551|NCT03901352|Drug|Placebo|Matching placebo tablets for oral administration
15867552|NCT03901352|Drug|Mirogabalin|Mirogabalin tablets for oral administration
15867553|NCT03901339|Drug|Sacituzumab Govitecan-hziy|Administered intravenously
15867554|NCT03901339|Drug|Eribulin|Administered intravenously per NCCN guidelines
15867555|NCT03901339|Drug|Capecitabine|Administered orally per NCCN guidelines
15867556|NCT03901339|Drug|Gemcitabine|Administered intravenously per NCCN guidelines
15867557|NCT03901339|Drug|Vinorelbine|Administered intravenously per NCCN guidelines
15867558|NCT03901326|Diagnostic Test|CT-FFR|When subjects are randomized to the CTA/CT-FFR arm, FFR based on the coronary CTA imaging will be measured. DeepFFR workstation is very dedicated software utilizing the original CTA imaging to meter simulated FFR values in artificial intelligence model.The first step is to extract a 3D coronary artery model and generate coronary centerlines which are similar to the routine reconstruction of coronary CTA. The centerlines are extracted using a minimal path extraction filter. Then a novel path-based deep learning model, referred to DeepFFR, is used to predict the simulated FFR values on the vascular centerlines. Deep learning algorithm is used to establish characteristic sample database of coronary hemodynamics characteristic parameters. When deep training model is proved to be valid, it is applied to a new lesion-specific measurement. Lesion-specific CT-FFR is defined as simulated FFR value 2-3cm downstream of an interest lesion.
15867559|NCT03901313|Drug|Treatment A - 400 mg Fasting|Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning under fasting conditions
15867560|NCT03901313|Drug|Treatment B - 400 mg Fed|Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning within 30 minutes (min) after a low-fat standard breakfast meal
15867561|NCT03901313|Drug|Treatment C - 200 mg Fed|Single oral 200 mg (1 × 200 mg capsule) dose of pexidartinib in the morning within 30 min after a low-fat standard breakfast meal
15867562|NCT03901300|Behavioral|Fundamental Motor Skills App|Lessons will be provided over the app each week with notifications sent 5 days/week over 12 weeks specific to randomized experimental group.
15867563|NCT03901300|Behavioral|Unstructured Physical Activity App|Lessons will be provided over the app each week with notifications sent 5 days/week over 12 weeks specific to randomized active comparator group.
15867564|NCT03901287|Other|dual energy CT scans|The procedure involves post processing and analysis of reconstructed images from dual energy CT scans available at the Bordeaux University Hospital and used in routine care, which will allow us to collect morphometric data (bronchial wall thickness and cross sectional area of small pulmonary vessels) and to assess pulmonary perfusion by studying iodine mapping and quantifying pulmonary perfusion blood volume (PVB)
15867600|NCT03900949|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic SCT
15867601|NCT03900949|Drug|Cytarabine|Given IV
15867602|NCT03900949|Drug|Daunorubicin Hydrochloride|Given IV
15867566|NCT03901274|Behavioral|Patient Centered Enhancements|The two PCEs are: enhancing mental health literacy and stigma reduction, and improving family-school-mental health partnerships. Depending on their time of enrollment, participants can be involved in this condition for one to three years. They will be asked to complete assessments during their therapy sessions periodically throughout the trial.
15867567|NCT03901261|Procedure|Neuro-imaging, Lumbar puncture|Optional Lumbar Puncture will be performed at inclusion visit Optional Neuro-Imaging (MRI (Magnetic Resonance Imaging) will be performed within 3 months after inclusion visit
15867568|NCT03901248|Other|No Intervention|Observational study
15867569|NCT03901235|Biological|Mesenchymal Stromal Cells|Suspension of mesenchymal stromal cells for intratissular injection
15867570|NCT03901222|Device|tDCS|20 minutes of anodal tDCS (C3 & C4/FPZ) 2mA or sham
15867571|NCT03901209|Device|Mid-face osteotomy|The mid-face osteotomy - typically according to LeFort I - is performed using a pulsed erbium-doped yttrium aluminium garnet (Er:YAG) laser driven by the CARLO robot arm.
15867572|NCT03901196|Diagnostic Test|Elemental analysis|LIBS multi elemental analysis of the specimen
15867573|NCT03901183|Other|Plant-based Diet|Patients are guided to change their nutrition to a plant-based diet.
15867574|NCT03901170|Drug|Letrozole 2.5mg|oral administration of letrozole 2.5mg/tab, 1tab once per day from stimulation Day 7 to hCG Day.
15867575|NCT03901157|Dietary Supplement|Yogurt A: Active|Free fat yogurt containing oil-filled alginate gels
15867576|NCT03901157|Dietary Supplement|Yogurt B: Control|Free fat yogurt containing the same amount of fat as the active one, and empty alginate gels
15867577|NCT03901144|Drug|Cream 1107.57|Moisturizing cream for topical application
15867578|NCT03901144|Drug|Glycerol cream|Moisturizing cream for topical application
15867579|NCT03901144|Drug|Paraffin cream|Emollient cream for topical application
15867580|NCT03901131|Drug|Norethisterone enantate/estradiol valerate (Mesigyna, BAY98-7040)|Follow clinical administration
15867581|NCT03901118|Drug|chiauranib|in the phase of pilot trial, 25mg orally once daily; in the formal phase, 50mg orally once daily
15867582|NCT03901118|Drug|etoposide|50mg orally once daily for 21 days, 7 days off, every 28 days for a cycle, 6 cycles at most
15867583|NCT03901118|Drug|paclitaxel|60mg/m2, i.v infusion on day 1, 8 and 15, every 21 days for a cycle, 6 cycles at most
15867584|NCT03901105|Drug|flortaucipir F18|No study drug will be administered. Scans previously acquired from Study I8D-MC-AZES (NCT02245737, Eli Lilly and Company sponsor) at baseline will be read by independent, blinded readers. IV injection, 240 megabecquerel (MBq) (6.5 mCi), single dose in AZES
15867585|NCT03901105|Procedure|Brain PET Scan|positron emission tomography (PET) scan of the brain
15867586|NCT03901092|Drug|flortaucipir F 18|No study drug will be administered.
15867587|NCT03901079|Other|single-arm study|single-arm study
15867588|NCT03901053|Device|Reaktiv AFO|This device is a carbon fiber ankle foot orthosis (brace) that contacts the foot and lower leg. It consists of a foot plate that is designed to protect the foot, a carbon fiber strut on the back that stores and returns energy, and a cuff that goes below the knee. It has a custom geometry and alignment that is specific to the individual.
15867589|NCT03901053|Device|PhatBrace AFO|Although lighter and thinner than the Reaktiv it has a similar overall design. The posterior strut is typically longer and the footplate is thinner, more compliant and less customized. Further, the device is formed into a single piece.
15867590|NCT03901040|Device|endoscopic ultrasound|endoscopic ultrasound with boutlinum toxin injection in the antrum of the stomach to decrease satiety
15867591|NCT03901027|Behavioral|Therapeutic Conversation Interventions|Parents (N=31) at the Children's Hospital at the National University Hospital of Iceland, got two sessions of the FAM-SOTC intervention focusing on emotional support, evidence based information and recommendations and on the strengths of family members. The parents meet with the Advanced Practice Nurse at the Children´s Hospital without the child in both sessions, but each session lasted for 45 to 90 minutes. The sessions were offered with 4-8 weeks interval.
15867592|NCT03901014|Other|Standard American diet|Standard American diet with 50% energy from carbohydrate, 30% from fat, and 20% from protein.
15867593|NCT03901014|Other|Very low carbohydrate diet|Ketogenic diet with <50g carbohydrate, 60-75% energy from fat, and 20% from protein
15867594|NCT03901001|Drug|sirolimus and oseltamivir|Sirolimus 1 mg daily and oseltamivir 75 mg bid for 5 days, both given orally. Extension of dosing to 10 days for oseltamivir and the study drug is allowed if there is slow recovery, lack of improvement, or deterioration.
15867595|NCT03901001|Drug|Oseltamivir|oral oseltamivir 75 mg bid alone for 5 days. Extension of dosing to 10 days for oseltamivir and the study drug is allowed if there is slow recovery, lack of improvement, or deterioration.
15867596|NCT03900988|Drug|N-acetyl cysteine|N-acetyl cysteine will be administered at 100 mg/kg daily as a continuous IV infusion (in 1000ml of 5% dextrose) over 24 hrs and oseltamivir 75 mg bid orally for 5 days. Extension of dosing to 10 days for oseltamivir and the study drug is allowed if there is slow recovery, lack of improvement, or deterioration.
15867597|NCT03900988|Drug|5% Dextrose|5% dextrose 1 liter given over 24 hrs and oral oseltamivir 75 mg bid for 5 days. Extension of dosing to 10 days for oseltamivir and the study drug is allowed if there is slow recovery, lack of improvement, or deterioration.
15867598|NCT03900962|Other|Home-based resistance training|"Patients completed two home-based resistance training sessions each week on non-consecutive days for 12 weeks. The programme was delivered online via individual playlists on Youtube (YouTube, San Bruno, California, USA), with each playlist involving an individually-prescribed series of pre-recorded exercise videos. Each session involved a dynamic warm-up followed by 11 resistance exercises using body weight and resistance bands, and finished with static stretching. Participants completed 1-2 sets of 5-12 repetitions at 4-7 on a modified 10-point rating of perceived exertion scale, which corresponded to qualitative descriptors of moderate to hard. Resistance training stimuli were progressed weekly by increasing the external load, modifying the exercise selection, increasing the number of repetitions, and/or increasing the number of sets."
15867599|NCT03900962|Other|Walking intervention|After the initial baseline assessment, participants recorded the number of steps they walked daily for seven days using a waist-worn pedometer. Participants maintained their usual physical activity levels during this period. Participants were then encouraged to increase their total steps walked each day by 5% each week during the 12-week intervention.
15867605|NCT03900936|Diagnostic Test|Neuropsychological tests|This study is not an intervention as such. We are simply comparing the scores of MCI patients who subsequently went on to develop dementia vs those who did not.
15867606|NCT03900923|Drug|98% pure CBD|A Bayesian optimal interval (BOIN) design was used, such that participants were assigned to cohorts of size 3 receiving doses of 3, 6, or 9 mg/kg/day, depending on the treatment response of participants in prior cohorts. The BOIN design has ended, and two doses have been tested and eliminated (3 and 6 mg/kg/day). We are now examining 9 mg/kg/day exclusively.
15867607|NCT03900910|Other|Gastric cancer prevention|Participants will receive the 13C-urea breath test and those with test positive will further receive H. pylori eradication treatment.
15867608|NCT03900897|Device|MED-EL SYNCHRONY PIN Cochlear Implant|Subjects will be implanted with the MED-EL SYNCHRONY PIN Cochlear Implant System with +FLEX24, +FLEX28, +FLEXSOFT electrode arrays. Subjects will be fit with the SONNETEAS (ear-level) and/or RONDO 2 (single-unit) external audio processors.
15867609|NCT03900884|Drug|Venetoclax|At commencement of study: Venetoclax will commence at 100 mg daily (oral) for days 1-21 of each 28 day cycle. This is a dose finding study so doses will be adjusted between 100 and 800 mg/day depending on dose escalation results and recommendation of the safety committee.
15867610|NCT03900884|Drug|Palbociclib|At commencement of study: Palbociclib will commence at 100 mg daily (oral) for days 1-21 of each 28 day cycle. This is a dose finding study so doses will be adjusted between 75 and 125 mg/day depending on dose escalation results and recommendation of the safety committee.
15867611|NCT03900884|Drug|Letrozole|Letrozole will be dosed daily at a fixed dose of 2.5 mg/day throughout the study.
15867612|NCT03900871|Drug|Acetylsalicylic acid|Aspirin (aspirin), also known as acetylsalicylic acid (acetylsalicylic acid), is a salicylic acid drug commonly used as a painkiller, antipyretic and anti-inflammatory drug. There is growing evidence that aspirin has a preventive effect on certain cancers, especially gastrointestinal cancers, and that taking aspirin every day can reduce the risk of colon cancer, and in vitro experiments have also shown that aspirin inhibits the growth of a variety of cancer cells and induces apoptosis.
15867613|NCT03900858|Drug|Isoniazid；Rifapentine|1 months (12 doses) of three-weekly rifapentine at a dose of 450mg plus isoniazid at a dose of 400mg given under direct observation
15867614|NCT03900845|Device|Dynamic Air Exchange - Rising Edge Design (DAE-RED)|The DAE-RED suspension system expels perspiration to the prosthesis exterior using a hybrid battery-powered pump and a body-weight activated pump. To use the DAE-RED, subjects will be fit with a modified patellar tendon-bearing socket that fits over a custom liner and sock. Up to four air intake ports are located proximally on the liner, approximately 25 mm superior to the socket brim. These ports incorporate a microvalve that allows air to flow into the liner-skin interstitial space while still maintaining a vacuum suspension. Distally, the pin lock has a 3-mm hole along its longitudinal axis that allows perspiration to be expelled into a distal reservoir. The prosthesis will also include: a standard aluminum pylon, pyramid adapters, and an Ossur Proflex XC prosthetic foot with Unity pump and foot cover.
15867615|NCT03900845|Device|Perforated elastomeric liner|The unique element of this perforated elastomeric liner are small perforations (~0.3 mm diameter), uniformly distributed on a 4 x 5 mm grid, but with no perforations on the distal umbrella, that allow perspiration to be exuded into the liner-socket interstitial space. To use the perforated elastomeric liner, subjects will be fit with a modified patellar tendon-bearing socket that fits over a sock and the perforated elastomeric liner with a pin lock. The sock, worn between the socket and the liner, is used to absorb perspiration that is transported through the perforations in the liner. When needed for residual limb volume control, additional socks will be donned and included in tare weighing. The prosthesis will also include: a standard aluminum pylon, pyramid adapters, and an Ossur Proflex XC prosthetic foot and cosmesis.
15867616|NCT03900845|Device|As-prescribed prosthesis|The individual's as-prescribed suspension system is the prosthesis prescription that the patient and their clinical care team believes is the best prosthesis for their needs.
15867617|NCT03900832|Other|Without Heating|Subject will complete walking protocol without any heating procedure
15867618|NCT03900832|Other|Warm Bath|"Subjects will sit in a warm bathtub with water up to their shoulders, while one arm will be out of water for BP and HR measurement. The water temperature and internal temperature (Tcore), BP and HR will be measured throughout the bath.
~The water temperature will be controlled between 38-41°C. Subjects will remain in the tub for ≤ 30 minutes. If the HR increases more than 15 -20 bpm, or a significant BP drop occurs (e.g. BP >20 mmHg), the subject will be removed from the bath even if the time is <30 min."
15867619|NCT03900832|Other|Neutral Bath|"Subjects will sit in a warm bathtub with water up to their shoulders, while one arm will be out of water for BP and HR measurement. The water temperature and internal temperature (Tcore), BP and HR will be measured throughout the bath.
~The water temperature will be controlled between 35 - 37°C. Subjects will remain in the tub for ≤ 30 minutes."
15867620|NCT03900832|Other|Heating Suit|The mean skin temperature Tsk will be controlled with a water-perfused suit worn by subjects. Whole-body heating will be accomplished by perfusing warm water (~ 45 - 50 °C) through the suit to elevate the Tsk to ≤ 38 °C (100 oF). Warm water is through plastic tubes, and subjects' skin will not directly touch warm water. The heating will be continued until the ∆Tcore reaches ~ 0. 6 - 1.0 °C. This may take approximately 60 - 90 min.
15867621|NCT03900832|Other|Lower limb warm water immersion|Subjects will sit on a chair and put their lower legs and feet in a bucket with warm water. The water level will be just below the knees (depth of approximately 40 cm). The water temperature will be monitored and controlled at ~38 - 42 °C throughout the 30 minutes. BP, HR, Tcore, the skin temperature and skin blood flow (e.g. on a thigh and/or forearm) will be measured before, during and after the lower limbs warm water immersion.
15867622|NCT03900832|Other|Gardner walking protocol|The Gardner protocol begins at 2 mph and 0% grade for 2 minutes. The grade increases by 2% every 2 minutes (the speed remains 2 mph) until the subject says they want to stop or 22 minutes maximum. BP and HR will also be measured throughout the protocol.
15867623|NCT03900819|Other|dexterity measurement|4 non-invasive tests will be performed
15867687|NCT03900273|Other|Preclinical Alzheimer's Cognitive Composite (PACC), Alzheimer's Disease Assessment Scale-Cognitive Scale (ADAS-Cog), and Functional Assessment Questionnaire (FAQ)|Established measures of Cognitive and Everyday Function
15867744|NCT03899805|Drug|Pembrolizumab|The drug blocks the PD-1 receptor, preventing binding and activation of PD-L1 and PD-L2. This mechanism causes the activation of T-cell mediated immune responses against tumor cells.
15867624|NCT03900806|Behavioral|online cognitive rehabilitation|The cognitive rehabilitation program will be based on the protocol of a frequently used meta-cognitive strategy approach applied in many rehabilitation centers in the Netherlands. The program consists of several modules that can be used in a flexible way, depending on the specific individual problems and goals. Therapists have undergone additional training in issues related to cancer-related cognitive impairment and problems occupationally active cancer survivors might experience at work. In both intervention arms, participants will receive access to a secured personal webpage, where all content relevant to the treatment sessions can be obtained.
15867625|NCT03900793|Drug|Losartan|Losartan will be administered orally daily on days 1-42 (6 weeks) with dose level assignments per Table 1 of the protocol. Dosing will be performed based on weight in kilograms and rounded to the nearest 12.5 mg (half of 25 mg tablet). Dose level 1 dosing will not exceed 50 mg daily and dose levels 2 and 3 dosing will not exceed 100 mg daily. Doses should be taken at approximately the same time daily and patients should fast for > 4 hours prior to dosing
15867626|NCT03900793|Drug|Sunitinib|Sunitinib will be administered orally daily on days 1-28 (4 weeks), followed by 14-day rest period (2 weeks). Dosing will be performed based on body surface area (BSA) in mg/m2 per Table 1 of the protocol. Doses should be taken at approximately the same time daily.
15867627|NCT03900780|Procedure|PGT-A|ovarian stimulation, oocyte aspiration, embryo culture until the blastocyst stage (day 5/6), TE biopsy, vitrification of all embryos in the blastocyst stage, PGT-A by NGS and finally embryo transfer of genetically normal embryos in cumulative frozen-thawed embryo transfer cycles
15867628|NCT03900780|Procedure|Control|ovarian stimulation, oocyte aspiration, embryo culture until the blastocyst stage, fresh embryo transfer of the morphologically best embryo on day 5/6, vitrification of supernumerary embryos and embryo transfer in cumulative frozen-thawed embryo transfer cycles if not pregnant from the fresh cycle.
15867629|NCT03900767|Other|Electronic Health Record intervention|AAC
15867630|NCT03900767|Behavioral|Smoking Cessation Intervention|Receive standard Utah Quitline treatment
15867631|NCT03900767|Behavioral|Telephone-Based Intervention|Receive text messages
15867632|NCT03900767|Behavioral|Telephone-Based Intervention|Receive phone calls
15867633|NCT03900754|Drug|Oxytocin|Intranasal administration of oxytocin
15867634|NCT03900754|Drug|Placebo|Placebo
15867635|NCT03900741|Procedure|Submerged healing|Bone regeneration of peri-implantitis defects using a bone xenograft and a resorbable collagen membrane, with flap suturing using a submerged healing protocol
15867636|NCT03900741|Procedure|Non-submerged healing|Bone regeneration of peri-implantitis defects using a bone xenograft and a resorbable collagen membrane, with flap suturing using a non-submerged healing protocol
15867637|NCT03900728|Device|Auriculotherapy with needles|Single-use 1.2mm acupuncture press needles attach to pre-specified acupoints on the participant's ears with adhesive disk/tape.
15867638|NCT03900728|Device|Auriculotherapy with beads|A trained co-investigator will place the beads onto prespecified acupoints of the participant's ears. An adhesive disk will adhere the beads to the ears.
15867639|NCT03900728|Device|Placebo Adhesive disks|Single-use adhesive disks without needles or beads.
15867640|NCT03900715|Drug|Luspatercept|Luspatercept
15867641|NCT03900702|Behavioral|Gaze-driven training games|Training games are played on a PC with attached eye-tracker. Games include embedded training principles to improve attentional control including resistance to distraction and inhibitory control.
15867642|NCT03900689|Other|Part 1 Survey Group|At the first study visit, participants will answer a series of survey questions about their neighborhoods, educational levels, social activities, access to transportation and food, healthcare management and where participants find social and spiritual support. General information such as age, ethnicity and address will also be collected.
15867643|NCT03900689|Other|Part 2 Focus Group|If participants from Part 1 agree to be contacted for Part 2, participants will be included in a focus group to explore unexpected findings and further investigate social determinants identified in Part 1.
15867644|NCT03900676|Drug|VB-1953 - 2%|Topical Gel
15867645|NCT03900676|Drug|VB-1953 - 0% (Vehicle)|Topical Gel
15867646|NCT03900663|Device|Anthropometric measures|Measure body weight , height , chest circumference , mid upper arm circumference,skin fold thickness , head circumference
15867647|NCT03900650|Behavioral|High provocation manipulation|Participants will engage in a laboratory task and will then report their emotions following the task.
15867648|NCT03900650|Behavioral|Low provocation manipulation|Participants will engage in a laboratory task and will then report their emotions following the task.
15867649|NCT03900650|Behavioral|Alcoholic beverage|Participants will consume an alcoholic beverage (vodka mixed with fruit juice) that is the equivalent of 3-4 standard alcoholic drinks based on their body weight.
15867650|NCT03900650|Behavioral|Non-alcoholic beverage|Participants will consume a nonalcoholic beverage (fruit juice) that is the isovolemic equivalent of 3-4 standard alcoholic drinks based on their body weight.
15867651|NCT03900637|Drug|Leuprorelin acetate|In premenopausal women, 3.75mg of leuprorelin acetate is subcutaneously administered once every 4 weeks for 16 weeks. (if needed, maximum for 24 weeks)
15867652|NCT03900637|Drug|Letrozole|2.5 mg tablet is orally administered once a day, without regard to meals, for 16 weeks (if needed, maximum for 24 weeks)
15867653|NCT03900637|Genetic|MammaPrint|In this study, patients with MammaPrint test is performed, neoadjuvant chemotherapy is conducted to genomic High Risk patients, and neoadjuvant endocrine therapy is conducted to Low Risk patients.
15867654|NCT03900624|Drug|Dexamethasone|Non-randomized, open-label, prospective use of intravenous dexamethasone for children admitted to the PICU with status asthmaticu
15867655|NCT03900611|Device|peripheral electrical stimulation|The subjects will undergo 8-week home-based peripheral electrical simulation on the median nerve. The peripheral electrical simulation will be performed once a day for 30 minutes. The stimulation will be active or sham depend on the group assignment.
15867656|NCT03900598|Drug|JNJ-67856633|JNJ-67856633 capsule will be administered orally.
15867657|NCT03900585|Behavioral|Interval walking|Interval walking administered by an app on the patient's telephone. Interval walking for 150 minutes/week for 10 weeks.
15867658|NCT03900572|Biological|HPV Vaccine|Intramuscular injection, 3 doses
15867659|NCT03900572|Drug|Placebo|Intramuscular injection, 3 doses
15867745|NCT03899792|Drug|LOXO-292|Oral LOXO-292
15867660|NCT03900559|Behavioral|NO-FEAR Airlines|"NO-FEAR Airlines is an Internet-based self-applied treatment program that allows people with Flying Phobia the exposure to images and sounds related to their phobic fears on a standard personal computer. The treatment can be totally self-applied.
~NO-FEAR Airlines contains 6 scenarios related to the flight process: (1) flight preparation, (2) airport, (3) boarding and taking off, (4) the central part of the flight, (5) the airplane's descent, approach to the runway, and landing, (6) sequences with images and auditory stimuli related to plane crashes."
15867661|NCT03900546|Device|MostCare|CO measurement using echocardiography and PRAM before and after noradrenaline dose change due to clinical reason
15867662|NCT03900533|Behavioral|Adjunctive group emotion regulation skills training|The adjunctive emotion regulation skills training is delivered in a group format once a week during 7 weeks to adolescents and parents jointly together with treatment as usual
15867663|NCT03900533|Behavioral|Treatment as usual|Treatment as usual at the child- and adolescent psychiatric clinic is delivered during 7 weeks
15867664|NCT03900507|Procedure|endometriosis surgery|"Medical treatment was initiated in patients with abdominal incision due to endometriotic focus in the incision line.
~however, patients with surgical excision indications were the study group."
15867665|NCT03900494|Device|VHC 1|Salbutamol 0.6-0.8 mg given 20-40 min. maximum four times depending on the bronchodilator response delivered via valved holding chamber 1. Same salbutamol dosing protocol for both arms. Only difference is the VHC used.
15867666|NCT03900494|Device|VHC 2|Salbutamol 0.6-0.8 mg given 20-40 min. maximum four times depending on the bronchodilator response delivered via valved holding chamber 2. Same salbutamol dosing protocol for both arms. Only difference is the VHC used.
15867667|NCT03900481|Procedure|Vertical gastric plication|Vertical gastric plication ( without cutting gastric wall) is a novel surgical approach for reducing the stomach capacity. A transoral or endoluminal approach (i.e. a procedure that requires no incision, because access is granted through the mouth) offers some potential additional benefit to the patient, because the procedures continue to become more and more minimally invasive.
15867668|NCT03900468|Device|Activa™ PC and Percept™ PC Neurostimulation Systems|Implanted DBS system consisting of a Neurostimulator, Leads, Extensions, and potential accessories including Burr Hole Cover, Clinician Programmer, Clinician programmer Therapy Application Software, Clinician Programmer Communicator, Application Card, External Neuro Stimulator (ENS), Patient Programmer, and Antenna.
15867669|NCT03900455|Device|Hydrocellular polyurethane foam multilayer dressing|Application of a multilayer foam with 4 flaps that can be adapted to several areas of the body (including the sacrum) and consists of: an external polyurethane film, which is impermeable to liquids and bacteria using dynamic transpiration, which can form an impenetrable barrier to protect the skin; a protective layer that shields the skin against accidental knocks and helps to spread the pressure; a highly absorbent and leak-proof layer that traps the exudate inside; a layer of hydrocellular polyurethane foam; and, finally, in contact with the skin, a perforated evenly covered layer of silicone gel adhesive. in addition to Standard preventive care
15867670|NCT03900455|Procedure|Standard preventive care|Pressure Ulcer risk assessment using the Braden scale within 8 hours of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score <17, daily inspection of the skin in the various pressure points and moving the patient at list every 4 hours. Management of possible incontinence, humidity control and prevention of skin damage and rubbing/friction during postural changes as per hospital procedure
15867671|NCT03900442|Drug|PTX-100|Doses of 500 to 2000 mg/m2 will be administered.
15867672|NCT03900429|Drug|MGL-3196|Tablet
15867673|NCT03900429|Drug|Placebo|Matching Tablets
15867674|NCT03900416|Behavioral|Mindfulness App|Mindfulness exercises will last 1-12 minutes. Each one asks participants to focus on something (e.g., breath, sounds, physical sensations) using guided instruction.
15867675|NCT03900403|Other|Walnut Intake|40g of daily walnut intake for 12 weeks
15867676|NCT03900390|Procedure|cross-preconditioning|After the establishment of the cardiopulmonary bypass, the ascending aorta of the CICP group will be crossclamped 2 minutes, separated by a 3-minute rest interval, and repeated successively on 2 occasions.
15867677|NCT03900377|Drug|SyB L-0501RI|The specified dose of SyB L-0501RI and rituximab will be administered by intravenous rapid infusion over 10 minutes on specified days.
15867678|NCT03900364|Procedure|partial nephrectomy|Partial nephrectomy is the standard technique for organ-sparing resection of renal tumors. The EAU Guidelines recommend partial nephrectomy to all patients with T1 tumours and can be performed either with an open, pure laparoscopic or robot-assisted approach, based on surgeon's expertise and skills.
15867679|NCT03900351|Procedure|Wii fit protocol of virtual reality games|the Wii fit session by standing on the Wii fit board with bare feet, hands on hips and both eyes open. Pretest on Wii fit was done to make the subject familiar with the board and tasks of weight shift .
15867680|NCT03900351|Procedure|Regular exercise rehabilitation protocol|It will be according to the criterion of Adams et al. (2012).
15867681|NCT03900325|Drug|Nimacimab|2.5 mg/kg
15867682|NCT03900325|Drug|Placebo|0.9% sodium chloride
15867683|NCT03900312|Behavioral|Asdzaan Be'eena' Program|The program will consist of 11 sessions conducted with girls ages 8-11 and their female caregivers. 5 of the 11 sessions will be taught to groups of 8-12 girls and their mothers, and 6 of the sessions will be taught to individual girl/female caregivers' dyads. The mix of group- and home-based lessons is based on findings from the formative phase about preference for certain topics to be taught in groups vs. individual dyads. Each of the sessions (group and individual) will be 60-90 minutes in duration and delivered by a trained Family Health Coach (FHC). Group sessions will take place at a local community center in a private room. Individual dyad sessions will take place in the girls'/female caregivers home or another private place of their choosing such as our local Johns Hopkins offices. The program will be conducted over 2.5-3 months with one session occurring every week for 11 weeks.
15867684|NCT03900299|Procedure|oncoplastic breast surgery|oncoplastic breast surgery with level 1 or 2 according to the case using intra operative frozen section to assess the margin
15867685|NCT03900286|Dietary Supplement|Total Dietary Replacement|Total Dietary Replacement
15867686|NCT03900273|Other|No Practice Effects (NPE) cognitive battery, and Miami Computerized Functional Assessment Scale (CFAS)|Novel measures of Cognitive and Everyday function
15867716|NCT03900013|Procedure|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft alone will be placed into the intraosseous defect
15867688|NCT03900260|Device|Softec HP1 Intraocular Lens|The Softec HP1 IOL is a single-piece, biconvex, ultraviolet absorbing intraocular lens designed for insertion into the posterior chamber of the human eye for visual correction of Aphakia in adults over the age of 21, and as a replacement of a damaged (cataract) natural lens.
15867689|NCT03900247|Device|REMAP EEG based BCI and SEM-Glove BioServo|EEG-based brain computer interface (BCI) will be adapted to individual ALS patients and modified to control external robotic devices
15867690|NCT03900234|Other|No intervention will be administered|No intervention will be studied. Clinical and ultrasound examinations will be used to find the prevalence of CVD.
15867691|NCT03900221|Other|No intervention|No intervention
15867692|NCT03900208|Diagnostic Test|Hystological analysis of ventricular tissue|Sections (4μm thick) will be stained with hematoxylin and eosin stain (H&E) for diagnosis. After diagnosis, sections of the representative heart tissue will be stained with a PicroSirius Red/Fast Green for fibrosis evaluation. All stained samples will be examined under digital and light microscope. Beside the location of adipose/fibrous tissue in the right or left ventricles and in the septum, seven high magnification fields (40x) will be evaluated in five regions of the myocardium.
15867693|NCT03900195|Other|BottlePEP|Positive expiratory device with a bottle
15867694|NCT03900182|Device|Hyperbaric Oxygen Therapy|The Hyperbaric Oxygen Therapy (HBOT) patients were placed in a chamber that was pressurized with air to 2.5 ATA during 15 min and were supplied 100% oxygen for 25 mins, followed by a 5-min air break. This cycle was repeated once and followed by 100% oxygen for 10 min, after which time the chamber was depressurized to 1 ATA over 15 min with 100% oxygen for a total treatment time of 100 min.
15867695|NCT03900169|Genetic|Genetic|Lipid profile
15867696|NCT03900156|Other|goal-setting|The interviewer will have access to key information from the initial assessment such as details of identified risks. Areas where the participant would like to make changes or improvements will be identified and prioritized, and up to five specific, realistic and achievable goals will be identified.
15867697|NCT03900143|Device|Tightra vaginal device|Vaginal device for improvement of vaginal symptoms, reduce vaginal laxity, improve sexual functioning, and treat stress urinary incontinence.
15867698|NCT03900130|Dietary Supplement|Preload|"In the 2 x 2 factorial design we vary two factors:
~caloric load of the preload such that it is either high calorie or low.
~protein to carbohydrate ratio of the preload such that it is either high or low"
15867699|NCT03900117|Radiation|split-course radiotherapy|Patients are irradiation at a palliative dose at the initial course: 40Gy/10f to PTV-GTV. The disease is re-evaluated one month after the end of the initial course using CT. The patient who achieved a partial remission according to the RECIST criteria and had a recovery of lung function should get the additional boost. At the second course, the tumor is repositioned and scanned. The residual tumor was then treated with the second course of radiotherapy. A dose of 28Gy/7f is delivered to the residue tumor.
15867700|NCT03900117|Drug|concurrent chemotherapy|Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration.
15867701|NCT03900104|Procedure|Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particles|Transcervical endometrial injection of technetium 99 m-labeled human albumin colloid particles, in 5 mL saline, 2 hours before surgery. Injection performed with a trans-cervical catheter
15867702|NCT03900104|Procedure|Cervical injection of technetium 99 m-labeled human albumin colloid particles|Cervical injection of technetium 99 m-labeled human albumin colloid particles, in 5 mL saline, 2 hours before surgery.
15867703|NCT03900091|Diagnostic Test|Multiplex PCR assay for meningitis|CSF from cases to be analysed with a FilmArray ME Panel
15867704|NCT03900091|Diagnostic Test|Multiplex vertical flow microarrray assay for meningitis|CSF from cases will also undergo analysis with a newly developed prototype for point-of-care diagnostic tool for CNS infections identification. The tool is a DNA-based vertical flow microarray technology printed on paper.
15867705|NCT03900091|Diagnostic Test|Profiling of blood proteins by multi-analyte Profiling technology|Blood from cases and controls to be analysed using Luminex technology to identify protein profiles associated with severe and non-severe infection. Myxovirus protein A (MxA) will also be analysed by the Luminex assay, to associate MxA levels with severe/non-severe infection.
15867706|NCT03900091|Other|Typing and whole genome sequencing|Pathogenic strains isolated from nasopharyngeal swabs from cases and controls will undergo whole genome sequencing (WGS) and typing .
15867707|NCT03900078|Other|Incisional negative pressure wound therapy|A negative pressure dressing is applied to the skin incision.
15867708|NCT03900078|Other|Wound dressing with adhesive tapes|Regular adhesive wound tapes are applied over the closed skin.
15867709|NCT03900065|Procedure|Preconditioning|Foam-mediated intermittent negative pressure will be applied to the skin of the planned flap for 5 days before surgery.
15867710|NCT03900052|Device|Haptic cane|• A haptic biofeedback cane was designed and manufactured to measure the user applied axial cane load, compare the load to the targeted 20% BW threshold, and then deliver a vibrotactile feedback in the cane handle when the loading was greater than threshold. The cane data acquisition was temporally synchronized to the motion analysis system and recorded axial cane loads at 100 Hz for later analysis. The haptic biofeedback cane consisted of a conventional bariatric walking cane (Patterson Medical Ltd) with a loadcell (Digi-Key100 LBS. Load Cell) placed inside a 3D printed modular cane foot. A microcontroller (Sparkfun™ Pro Micro), SD disk storage (Sparkfun™ OpenLog), eccentric rotating mass vibration motor (model 306-109, Precision Microdrives Limited), USB communications port, and battery completed the system.
15867711|NCT03900052|Device|typical cane|Typical training cane loading training
15867712|NCT03900039|Device|Highly Cross Linked Polyethylene and oxidized zirconium femoral head|"Differing bearing surfaces:
~Conventional polyethylene versus cobalt Chrome heads
~Conventional polyethylene versus Oxidized Zirconium heads
~Highly Cross-linked polyethylene versus Cobalt Chrome heads
~Highly Cross-linked polyethylene versus Oxidized Zirconium heads"
15867713|NCT03900026|Drug|Evolocumab|REPATHA (evolocumab) is a human immunoglobulin G2 (IgG2) monoclonal antibody that has high affinity binding to Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9); it will be administered via subcutaneous injection
15867714|NCT03900026|Other|Placebo|Placebo cartridges will contain vehicle only; placebo will be administered via subcutaneous injection.
15867715|NCT03900013|Procedure|Injectable platelet rich fibrin combined with DFDBA|The i-PRF will be mixed with bone graft then will be placed into the intraosseous defect
15867717|NCT03900000|Other|Physiotherapy|Ambulatory leg-muscle oriented physiotherapy (2 x 45 minutes per week for at least 8 weeks) at Aachen University Hospital. Daily protocol of leg muscle training, exercises, sufficient fluid intake of 2liter/day, pressure stockings.
15867718|NCT03899987|Drug|Aspirin|Given PO
15867719|NCT03899987|Procedure|Radical Prostatectomy|Undergo radical prostatectomy
15867720|NCT03899987|Biological|Recombinant Interferon Alfa-2b|Given IV
15867721|NCT03899987|Drug|Rintatolimod|Given IV
15867722|NCT03899974|Other|Test meal|"Participants received in random order the three test meal (700Kcal, 80g available carbohydrates) containing breads prepared with amylose-rich wheat flours (70% or 85%) or conventional flour. Blood samples were collected at fasting and every 30 minutes over 4 hours. Breath hydrogen was evaluated as a marker of intestinal fermentation. Participants underwent Visual Analogue Scale to assess subjective appetite sensations.
~After 4 hours, all participants consumed a standard lunch (700 kcal, 100 g available carbohydrates) identical on all the three experimental days to evaluate the second meal effect from breakfast to lunch."
15867723|NCT03899961|Drug|Oxytocin|Oxytocin 2.5 U i.v.
15867724|NCT03899961|Drug|Carbetocin|Carbetocin 100 µg i.v.
15867725|NCT03899948|Behavioral|Teacher Anxiety Program for Elementary Students|TAPES consists of three core components: 1) training in evidenced-based anxiety reduction strategies that teachers will implement to identify and assist specific anxious students and classroom-wide strategies helpful to all students, 2) evidenced-based material for teachers to review with parents regarding how to reduce student anxiety at home, thus improving school-home communication and shared goals and 3) training in how to conduct 5 brief (30 minute) teacher-parent-student meetings to teach and practice the TAPES anxiety-reduction strategies.
15867726|NCT03899948|Behavioral|Teacher Anxiety Training|The TAT is a 3-hour professional development training for teachers. Training focuses on recognizing the signs and symptoms related to child anxiety and utilizing classroom-wide strategies to help reduce anxiety in the classroom.
15867727|NCT03899935|Procedure|Laparoscopy|Laparoscopy for endometriosis
15867728|NCT03899922|Drug|Drugs inducing uveitis|Drugs susceptible to induce uveitis
15867729|NCT03899909|Drug|GLPG3121 SAD|GLPG3121 oral suspension, single ascending doses
15867730|NCT03899909|Drug|Placebo SAD|Placebo oral suspension
15867731|NCT03899909|Drug|GLPG3121 MAD|GLPG3121 oral suspension, multiple ascending doses, daily for 13 days
15867732|NCT03899909|Drug|Placebo MAD|Placebo oral suspension, daily for 13 days
15867733|NCT03899883|Drug|Pegloticase 8 MG/ML [Krystexxa]|One time dosing of pegloticase will be administered. Participants will receive an infusion of pegloticase over two hours in the outpatient clinical and translational research center (CTRC) at Children's Hospital Colorado, and will be monitored after infusion.
15867734|NCT03899870|Procedure|Rectal resection|Patients underwent anterior or low anterior resection. Patients with tumors in the lower third of the rectum where anal sphincters could not be preserved underwent abdominoperineal resection. In majority of the cases, inferior mesenteric artery (IMA) was ligated caudal to the origin of the left colic artery. For the tumors of the upper rectum, partial excision of the mesorectum was performed up to the minimum of 5 cm from the inferior aspect of the tumor. For the tumors of the middle and low rectum a total mesorectum excision was done with the minimum distal mucosal margin of 1 to 2 cm. Ileostomy was performed in cases where colon was poorly prepared, anastomotic leak test was positive or colonel anastomosis was made. In most of the cases, open surgery was performed. Laparoscopic surgery was performed in selected cases. Wide local excision was performed in selected cases with T1 tumors without locoregional lymphadenopathy.
15867735|NCT03899870|Drug|Neoadjuvant therapy|Patients with locally advanced disease (T3, T4) or lymph nodal positive disease were offered neoadjuvant therapy. In the neoadjuvant therapy, we used 45 Gy in 25 fractions with concurrent 5-fluorouracil [5-FU] and patients were operated 8 to 10 weeks after neoadjuvant therapy. In some cases, especially the elderly patients with multiple co-morbidities, we used short-course pelvic radiation therapy which included 25 Gy in 5 fractions over 1 week.
15867736|NCT03899870|Drug|Adjuvant therapy|Patients with locally advanced disease (T3, T4) or lymph nodal positive disease were offered adjuvant therapy. In most of the cases, FOLFOX (leucovorin, 5-FU, oxaliplatin) regimen was used and for elderly patients who could not tolerated this regimen, we used oral capecitabine.
15867737|NCT03899857|Drug|Pembrolizumab|Pembrolizumab will be added to standard of care
15867738|NCT03899844|Other|Blood collection, PiB PET/MRI, and cognitive testing|Blood and imaging results will be analyzed for amyloid beta. Cognitive testing will be performed to determine clinical and cognitive status.
15867739|NCT03899831|Behavioral|Function-Based Elopement Treatment (FBET)|"The Function-Based Elopement Treatment (FBET) includes 12 appointments over 16 weeks. FBET focuses on parent-training, with the parent implementing procedures with therapist support. The goals of FBET are:
~to create a safer environment
~teach adaptive skills to replace elopement
~arrange the environment and rewards to reduce elopement
~and teach caregivers how to respond if elopement occurs Psychoeducation is emphasized, including discussions of elopement as a learned behavior, reinforcement, functions of elopement, extinction, and descriptions of treatment components. The FBET manual includes scripted text, examples, caregiver completed activities, and checks for understanding."
15867740|NCT03899831|Behavioral|Parent Education Program (PEP)|The Parent Education Program (PEP) will include 12 appointments over 16 weeks, focused on general education about autism spectrum disorder and resources about elopement prevention. PEP will be administered by a Board Certified Behavior Analyst (BCBA). Participants randomized to the PEP study arm can receive the FBET intervention after completing the 16 week study period.
15867741|NCT03899818|Device|drug-eluting balloon|Patients will be randomized to drug-eluting balloon (DEB) or standard therapy with second generation drug-eluting stent (DES)
15867742|NCT03899818|Device|drug-eluting stent|Patients will be randomized to drug-eluting balloon (DEB) or standard therapy with second generation drug-eluting stent (DES).
15867743|NCT03899805|Drug|Eribulin|The ability of chemotherapy to kill cancer cells depends on its ability to halt cell division. Usually, the drugs work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die. The faster the cells are dividing, the more likely it is that chemotherapy will kill the cells, causing the tumor to shrink. They also induce cell suicide (self-death or apoptosis).
15867746|NCT03899779|Other|Face-to-face hypnotherapy|12 weeks treatment with face-to-face hypnotherapy (6 individual, bi-weekly sessions)
15867749|NCT03899766|Other|Animal Assisted Intervention|Operators of AAI and their dog meet the child and his/her parent in the waiting room and facilitates interaction using their professional characteristics. The interaction continue in the venipuncture room during the procedure and at its conclusion; in fact, the operators accompany the child and his/her parent outside the venipuncture room, to not abruptly interrupt the interaction.
15867750|NCT03899766|Other|Clowns|Hospital clowns meet the child and his/her parent in the waiting room and facilitates interaction using their professional characteristics. The interaction continue in the venipuncture room during the procedure and at its conclusion; in fact, the operators accompany the child and his/her parent outside the venipuncture room, to not abruptly interrupt the interaction.
15867751|NCT03899766|Other|Musicians|Musicians meet the child and his/her parent in the waiting room and facilitates interaction using their professional characteristics. The interaction continue in the venipuncture room during the procedure and at its conclusion; in fact, the operators accompany the child and his/her parent outside the venipuncture room, to not abruptly interrupt the interaction.
15867752|NCT03899753|Device|2-Octyl Cyanoacrylate and Mesh|2-Octyl Cyanoacrylate and a mesh will be applied to final closure of wounds after undergoing a Total Shoulder Arthroplasty
15867753|NCT03899753|Device|2-Octyl Cyanoacrylate|Incisions will be closed with 2-Octyl Cyanoacrylate after undergoing a Total shoulder arthroplasty
15867754|NCT03899740|Other|Brainstorming 1|Expert recommendation statements will be collected for peer evaluation.
15867755|NCT03899740|Other|Ranking - Round 1|Each participant will rank each statement using a likert scale: strongly disagree -- disagree -- neutral -- agree -- strongly agree.
15867756|NCT03899740|Other|Ranking - Round 2|Each participant will rank each statement using a likert scale: strongly disagree -- disagree -- neutral -- agree -- strongly agree.
15867757|NCT03899740|Other|Ranking - Round 3|Each participant will rank each statement using a likert scale: strongly disagree -- disagree -- neutral -- agree -- strongly agree.
15867758|NCT03899727|Device|Polysomnography|Polysomnography, also called a sleep study, is a test used to diagnose sleep disorders. Polysomnography records your brain waves, the oxygen level in your blood, heart rate and breathing, as well as eye and leg movements during the study
15867759|NCT03899714|Other|Cryotherapy|Crushed ice in a plastic bag will be used, as it is a widely accessible and financially convenient method of cryotherapy. One half of a kilogram of ice will be placed in a plastic bag. The plastic bags will be 17 cm wide and 22 cm long. The air will be squeezed out of the bag and it will be sealed. The bag will be wrapped in a wet towel and applied to the tested area. Every five bags of crushed ice will be kept in an insulated foam container containing one kilogram of dry ice. Dry ice has a temperature of negative 80 degrees Celsius, and is used to keep the bags of crushed ice in a frozen state till the participants are briefed and the testing began.
15867760|NCT03899701|Procedure|PEC I and PEC II blocks|Participants will get a PEC I block with 10ml of 0.375% ropivacaine and a PEC II block with 20ml of 0.375% ropivacaine using ultrasound guidance.
15867761|NCT03899688|Procedure|Maxillary sinus augmentation|Surgical technique for increasing the vertical bone height of the posterior maxilla an antrostomy of about 5 mm in height and 10 mm long will be prepared using a diamond insert mounted on a sonic-air surgical instrument. The Schneiderian membrane will be elevated and clinical measurements will be performed using an UNC 15 probe. The space obtained underneath the sinus mucosa will be filled with the xenograft and a resorbable collagen membrane will be placed to cover the antrostomy only at the randomly selected control sites.
15867762|NCT03899675|Dietary Supplement|Placebo|On the first day of collection, the volunteers will not take placebo intake, the data will be collected in a standardized way, respecting the times defined for the analysis of the cardiac activity. Then the collection will be continued. On the next day of evaluation, volunteers will receive a capsule containing 300 mg of placebo and will be advised to consume 1 hour before the procedure.
15867763|NCT03899675|Other|Caffeine|On the first day of collection, the volunteers will not take caffeine intake, the data will be collected in a standardized way, respecting the times defined for the analysis of the cardiac activity. Then the collection will be continued. On the next day of evaluation, volunteers will receive a capsule containing 300 mg of caffeine and will be advised to consume 1 hour before the procedure.
15867764|NCT03899662|Other|Cognitive Training|Cognitive training included memory, attention, velocity, intelligence
15867765|NCT03899662|Other|Physical Training|Physical training included aerobic, strength, flexibility and balance.
15867766|NCT03899649|Drug|SOC|Standard of Care treatment
15867767|NCT03899649|Device|NanoKnife System|Irreversible Electroporation
15867768|NCT03899636|Drug|Modified FOLFIRINOX Regimen|Chemotherapy regimen of leucovorin, fluorouracil, irinotecan, and oxaliplatin
15867769|NCT03899636|Device|NanoKnife System|IRE using NanoKnife System
15867770|NCT03899610|Drug|Neoadjuvant chemotherapy+Durvalumab+Tremelimumab|"Neoadjuvant treatment:
~Standard chemotherapy + Durvalumab + Tremelimumab Durvalumab : 1500mg q3 weeks (total 3 dosing) Tremelimumab : 75mg q 3 weeks (total 3 dosing) Chemotherapy regimen: Paclitaxel 175 mg/m2 , Carboplatin AUC 5-6 q3 weeks (total 3 dosing)
~Interval debulking surgery
~Adjuvant treatment:
~Standard chemotherapy + Durvalumab Durvalumab; 1120mg q3 weeks (total 12 dosing) Chemotherapy regimen: Paclitaxel 175mg/m2, carboplatin AUC 5-6 q 3weeks (total3 dosing)"
15867771|NCT03899597|Drug|Oxytocin|The intervention group (ARTCON) will receive the standard assignment for the elective caesarean section, but at least one hour before surgery oxytocin exposure will be performed with cardiotocographic (CTG) monitoring and obstetrical supervision.
15867772|NCT03899597|Other|Normal saline|The control group (SA) will receive the standard assignment for the elective caesarean section, but at least one hour before surgery placebo exposure will be performed with cardiotocographic (CTG) monitoring and obstetrical supervision.
15867773|NCT03899584|Drug|4-Aminopyridine|Each patient will take 10 mg per kilogram of weight (example: a person weighing 60 kg, will take two capsules three times a day after meals, for a total of 6 capsules / day). Each capsule will contain 10 milligrams of 4-Aminopyridine that will allow to be administered sequentially at progressively higher doses / day. The dose of 4-aminopyridine will increase 10 mg / 2 to 4 weeks.
15867774|NCT03899584|Drug|Placebo oral capsule|The placebo arm will include a placebo of microcrystalline cellulose.
15867775|NCT03899571|Drug|Oseltamivir Oral Capsule for 5 days post-exposure|Patients will receive oseltamivir for 5 days after last influenza exposure.
15867825|NCT03899194|Drug|escitalopram|escitalopram 10-20 mg/d
15867777|NCT03899558|Device|Humidified nasal high-flow device|Humidified nasal high-flow device which delivers warmed, humidified air at flow rates of up to 60 litres per minute via a nasal cannula interface. Intended delivery at 30 L/min at 37 degrees Celsius, if tolerated.
15867778|NCT03899545|Other|Serratus Plane Block|0.5 ml /kg Bupivacaine/lidocaine mixture will be injected onto the serratus muscle
15867779|NCT03899545|Other|Serratus Plane Block plus Pectoral I Block|0.5 ml / kg %0.25 Bupivacaine/ %1 lidocaine mixture will be injected onto the serratus muscle and injected between the pectoralis minor/pectoralis major muscles.2/3 of the total drug will be applied for the serratus plane block and 1/3 of the total drug for the pectoral I block. If the total amount of the drug is less than 30 ml, it will be completed with isotonic saline to 30 ml.
15867780|NCT03899532|Device|Remote Ischemic Conditioning|Standard manual blood pressure cuff
15867781|NCT03899532|Other|No-Remote Ischemic Conditioning|No-Remote Ischemic Conditioning
15867782|NCT03899506|Drug|Olanzapine|Patients receiving Olanzapine per the ED protocol
15867783|NCT03899506|Drug|Midazolam|Patients receiving Midazolam per the ED protocol
15867784|NCT03899493|Other|Observation|Patients will be dispositioned to usual obstetric care which may include minimal intervention if spontaneous labor, induction of labor or augmentation of labor as indicated and dictated by the participants obstetrical provider. This study is observational only.
15867785|NCT03899480|Biological|Haploidentical Natural Killer (NK) Cells|infusion with N-803 activated NK cells
15867786|NCT03899467|Drug|GT0918|anti-tumor activity
15867787|NCT03899454|Drug|Garcinia-mangostana-L-rind and Solanum-Lycopersicum-Fructus mixture-extract|Administration of mixed extract of Garcinia mangostana 400mg and Solanum Lycopersicum Fructus 200mg (OKSI(R) POM TR 193324351)
15867788|NCT03899454|Drug|Placebo Control|Placebo Control
15867789|NCT03899441|Other|Video|Two short animated videos - one that reviews minimally-invasive surgery and sentinel lymph node mapping and biopsy for endometrial cancer treatment. This video as reviews possible complications. The second video reviews peri-operative instructions.
15867790|NCT03899428|Drug|Durvalumab|Durvalumab 1500 mg IV (intravenous infusion)
15867791|NCT03899428|Drug|Sorafenib|Prescribed by physician.
15867792|NCT03899428|Drug|Lenvatinib|Prescribed by physician.
15867793|NCT03899428|Drug|Regorafenib|Prescribed by physician.
15867794|NCT03899428|Drug|Cabozantinib|Prescribed by physician.
15867795|NCT03899415|Biological|TCR redirected T cells|HBV antigen specific TCR redirected T cell Infusions. Subjects will receive 1x10^4 - 5x10^6 TCR redirected T cells by IV infusion.
15867796|NCT03899402|Drug|Insulin|Standard of care insulin for pump or injection and serves as a control
15867797|NCT03899402|Drug|Semaglutide|Injectable weekly GLP-1RA given as open label experimental drug
15867798|NCT03899402|Drug|Dapagliflozin|Oral daily SGLT2 Inhibitor given as experimental drug
15867799|NCT03899402|Drug|Placebo to Dapagliflozin|Placebo to Dapagliflozin given as a control to the experimental drug
15867800|NCT03899389|Diagnostic Test|plasma samples collection|Trimethylamine N-oxide (TMAO) concentration will be determined in plasma samples
15867801|NCT03899376|Radiation|Volumetric modulated arc therapy|VMAT therapy focuses on reducing the dose radiation in adjacent organs at risk
15867802|NCT03899376|Radiation|conventional radiotherapy|Radiotherapy focus on pelvis area
15867803|NCT03899363|Procedure|custom thermoplastic orthosis|extended the DIP by a custom thermoplastic orthosis or the Kirschner wire through the joint
15867804|NCT03899350|Other|No intervention|No intervention
15867805|NCT03899337|Drug|Acalabrutinib|100mg capsule, PO, BD
15867806|NCT03899337|Drug|Cyclophosphamide|750mg/m^2, IV bolus
15867807|NCT03899337|Drug|Doxorubicin|50mg/m^2, IV bolus
15867808|NCT03899337|Drug|Vincristine|1.4mg/m^2, IV infusion
15867809|NCT03899337|Drug|Prednisolone|40mg/m^2, PO, OD
15867810|NCT03899337|Drug|Rituximab|375mg/m^2, IV infusion
15867811|NCT03899324|Drug|Bumetanide white, oblong, scored tablet|Bumetanide with a titration period
15867812|NCT03899324|Drug|Placebo white, oblong, scored tablet|placebo intake identically to group 1
15867813|NCT03899311|Other|protein-sparing modified fast diet|a PSMF diet follow the usual care format in the Center
15867814|NCT03899298|Biological|Amniotic and Umbilical Cord Tissue Procedure|Amniotic and Umbilical Cord Cell Therapy with protocols dependent on the patient condition. Protocols include options for IV, Injection, Intranasal and/or Nebulizer.
15867815|NCT03899285|Drug|Citalopram 20mg or 40 mg (phase 2)|For non-responders, a randomisation 1:1 was chosen. The group A will receive 40 mg and the group B will receive 20 mg once daily of citalopram for 14 days.
15867816|NCT03899259|Drug|Baricitinib|Administered orally
15867817|NCT03899259|Drug|Placebo|Administered orally
15867818|NCT03899246|Drug|Eight Percent Topical Capsaicin|See arm description
15867819|NCT03899233|Device|Fractional CO2 laser|Low power fractional CO2 laser with a power of 12 watts, spacing 800 micrometer (7.3% density), and dwell time 300 microsecond
15867820|NCT03899233|Drug|Tranexamic acid intradermal microinjections|Tranexamic acid 500mg/5ml ampules
15867821|NCT03899220|Behavioral|Project Matter|This intervention includes 5 face-to-face therapy sessions with a trained clinician plus a bidirectional text component that queries mood, substance use, and medication adherence. Both the intervention group and the enhanced treatment as usual (E-TAU) involve a one-session behavioral engagement in care intervention as well as substance use treatment counseling.
15867822|NCT03899207|Other|training +acupressure|".Training+acupressure group; received training for coping with PMS prepared under the guidance of HBM and The Booklet of Training for Coping with Premenstrual Symptoms including information about the training given. In addition to the training, acupressure was applied by the researcher twice a week and 24 times in total. Acupressure application was continued with the same frequency until the end of the study (24 times in total for 3 months). One month after the first home visit, reminder training for coping with premenstrual symptoms was given to the women"
15867823|NCT03899207|Other|training|"Training Group; received the training for coping with PMS prepared under the guidance of HBM and The Booklet of Training for Coping with Premenstrual Symptoms including information about the training given. One month after the first home visit, reminder training was given to the women."
15867824|NCT03899194|Dietary Supplement|fish oil capsules|fish oil capsules(1000mg，EPA 180mg；DHA 120mg)
15867826|NCT03899181|Device|Translumbosacral Neuromodulation Therapy (TNT)|A probe with 2 pairs of bipolar steel ring electrodes, will be placed in the rectum. At each site a mapping procedure is performed with single stimulus coil to assess the motor threshold intensity, defined as the minimum level of magnetic stimulation intensity required to achieve an anal and rectal MEP response of 10 microvolts and an anterior tibialis MEP of 20 microvolts with 50% of trials.The intensity for TNT at each site is capped at a maximum of 150% above this threshold to comply with safety guidelines. Thus, intensity of magnetic stimulations will be individualized. Bilateral lumbar stimulations (rTLMS) are administered at L2/L3 disc space, and sacral stimulations (rTSMS) at S2/S3 level. Next a 70 mm double air film self-cooling coil is positioned randomly over one of the 4 sites, held in place by a coil fixator and 300 or 450 stimulations are delivered. After a 5 min rest the cycle is repeated (Total =600-900/site).The coil is moved to the opposite side and it is repeated.
15867827|NCT03899181|Other|Sham TNT Therapy|This is the sham TNT treatment as mentioned in the different ARMs using the fake coil with no magnetic stimulations.
15867828|NCT03899168|Other|Social Tag Popularity|The relative size of treatment tags in a tag cloud was either larger for antidepressant treatments or psychotherapy treatments.
15867829|NCT03899168|Other|Confidence in Prior Attitudes|Participants thought back of situations in which they were either confident or doubtful about their own knowledge. This should elicit a mindset where participants are more or less confident about their own prior attitudes.
15867830|NCT03899168|Other|Source Credibility|The source credibility of the community that allegedly collected and labelled the blog posts was either high or low in terms of expertise. Either experts (high credibility) or first semester students (low credibility) did allegedly collect blog posts. This was indicated by banners on top of the navigation platform in the internet browser.
15867831|NCT03899155|Drug|Nivolumab|Solution for IV Injection
15867832|NCT03899142|Biological|a human hepatitis B immunoglobulin solution for injection for intramuscular administration|intramuscular administration
15867833|NCT03899129|Procedure|simultaneous working length control using E-CONNECT S|E-CONNECT S (Eighteeth medical technology Co., Ltd, china) is an endomotor with integrated apex locator newly introduced in the market with continuous WL measuring function. It contains an optional module for rotary instrumentation, allowing the device to function as a low-speed handpiece, apex locator, or a combination of both. This motor has an attention-grabbing property that when an instrument reaches the predetermined working length, the motor automatically stops the instrumentation. Thus, it can be concluded that automatically stopping instrumentation when the instrument reaches the working length would decrease postoperative pain compared with manually controlling the working length by using stoppers during instrumentation (separate length determination and root canal preparation).
15867834|NCT03899129|Procedure|separate length determination and root canal preparation using Root ZX apex locator.|Using manual control of the working length by using stoppers during instrumentation (separate length determination and root canal preparation) using Root ZX apex locator.
15867835|NCT03899116|Other|deflation of pneumatic tourniquet|gradual deflation with variable degrees
15867836|NCT03899103|Drug|Rituximab|First course Course Rituximab at Randomization.
15867837|NCT03899103|Drug|Mycophenolate Mofetil|Addition of Maintenance Mycophenolate Mofetil from 4 Month onwards
15867838|NCT03899090|Behavioral|Float pool|Subject floats supine in a pool of water saturated with Epsom salt in an environment which minimizes stimulation of the nervous system, including reduced light, sound, and pressure on the spinal cord.
15867839|NCT03899090|Behavioral|Float chair|Subject floats supine in a zero-gravity chair in an environment which minimizes stimulation of the nervous system, including reduced light, sound, and pressure on the spinal cord.
15867840|NCT03899077|Drug|Apalutamide|Apalutamide 240mg daily for 6 months (i.e. 6 28-day cycles); oral use
15867841|NCT03899077|Drug|Leuprorelin Acetate 45Mg Powder for Injection Suspension Vial|Leuprorelin acetate 45mg for 6 months; subcutaneous use
15867842|NCT03899077|Drug|Goserelin Acetate 10.8 MG Subcutaneous Implant|Goserelin acetate 10.8mg for 6 months; subcutaneous use
15867843|NCT03899077|Drug|Triptorelin Pamoate|Triptorelin pamoate 22.5mg for 6 months; intramuscular use
15867844|NCT03899077|Drug|Degarelix acetate|Degarelix acetate 80mg for 6 months; subcutaneous use
15867845|NCT03899064|Drug|Induction: Application of MC2-01 Cream, irradiation|Repeated applications of MC2-01 Cream (CAL/BDP, 0.005%/0.064%), followed by irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation
15867846|NCT03899064|Drug|Induction: Application of MC2-01 Cream, no irradiation|Repeated applications of MC2-01 Cream, CAL/BDP, 0.005%/0.064%, no irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation
15867847|NCT03899064|Drug|Induction: Applications of MC2-01 vehicle, irradiation|Repeated applications of MC2-01 cream, followed by irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation
15867848|NCT03899064|Drug|Induction: Applications of MC2-01 vehicle, no irradiation|Repeated applications of MC2-01 vehicle, no irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation
15867849|NCT03899064|Drug|Challenge: Application of MC2-01 Cream, irradiation|Single application of MC2-01 Cream (CAL/BDP, 0.005%/0.064%), followed by irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema and edema
15867850|NCT03899064|Drug|Challenge: Application of MC2-01 Cream, no irradiation|Single application of MC2-01 Cream (CAL/BDP, 0.005%/0.064%), no irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema and edema
15867851|NCT03899064|Drug|Challenge: Applications of MC2-01 vehicle, irradiation|Single application of MC2-01 vehicle, followed by irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema and edema
15867852|NCT03899064|Drug|Challenge: Applications of MC2-01 vehicle, no irradiation|Single application of MC2-01 vehicle, no irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema and edema
15867853|NCT03899064|Drug|Challenge: Control, irradiation|No application, but irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema and edema
15868375|NCT03894852|Diagnostic Test|PCR and cytogenetics|detection of SRSF2 gene mutation and cytogenetic studies
15867854|NCT03899051|Procedure|interdental papilla reconstructive surgery with PRF|Papilla reconstruction would be done with platelet rich fibrin
15867855|NCT03899051|Procedure|interdental papilla reconstructive surgery with subepithelial connective tissue graft|Papilla reconstruction would be done with subepithelial connective tissue graft
15867856|NCT03899038|Procedure|spinal anesthesia|Patients will receive real-time ultrasound guided spinal anesthesia using Taylor's approach. Various doses of bupivacaine 0.5% (Bupivacaine hydrochloride injection, Harvest Pharmaceutical CO., LTD., Shanghai, China) will be administered.
15867857|NCT03899025|Radiation|CT|CT = computed tomography of the hand/wrist HRpQCT = high resolution peripheral quantitative CT scan of the hand/wrist
15867858|NCT03899012|Procedure|Incisional Hernia Surgery|Verification of the accuracy in the collection of 21 selected variables in the Spanish EVEREG Incisional Hernia Surgery Registry
15867859|NCT03898999|Other|Overall status|An assessment is made of the participants measuring both the joint range of the ankle and the balance and risk of falls.
15867860|NCT03898986|Biological|Live attenuated influenza vaccine (LAIV4)|LAIV4 vaccine dosage is 0.2 mL. The vaccine will be administered as an intranasal spray. Each sprayer contains a single dose of FluMist® Quadrivalent; approximately one-half of the contents should be administered into each nostril. 0.1 mL (i.e., half of the dose from a single FluMist sprayer) is administered into each nostril while the recipient is in an upright position. Insert the tip of the sprayer just inside the nose and rapidly depress the plunger until the dose-divider clip stops the plunger. The dose-divider clip is removed from the sprayer to administer the second half of the dose (0.1 mL) into the other nostril.
15867861|NCT03898986|Biological|Inactivated Influenza Vaccine (IIV4)|IIV4 vaccine will be administered as a 0.5 mL dose, with a sterile, disposable syringe and needle by IM injection.
15867862|NCT03898973|Biological|Quadrivalent inactivated influenza vaccine (IIV)|Intramuscular Injection. Participants will receive the inactivated flu vaccine into anterior quadriceps.
15867863|NCT03898960|Device|NIMBUS Device|NIMBUS Geometric Clot Extractor
15867864|NCT03898947|Procedure|Diagnostic hysteroscopy and targeted endometrial biopsy|Diagnostic hysteroscopy and targeted endometrial biopsy
15867865|NCT03898934|Drug|Vitamin D|receive 6000iu daily for 8 weeks
15867866|NCT03898934|Drug|Placebo Oral Tablet|placebo for the same period
15867867|NCT03898921|Radiation|stereotactic body radiotherapy (SBRT)|Radiotherapy dose is 36-54 Gy, irradiated in 3 times, every other day, completed within 1 week.
15867868|NCT03898921|Procedure|Radiofrequency ablation (RFA)|RFA with a safe margin, RFA again if residual,no more than 3 times.
15867869|NCT03898908|Drug|encorafenib|"Encorafenib 75mg and 50mg (capsules) for a 450mg daily for oral administration during 56 days and after local radiation treatment.
~If no progression of disease progression (PD) is reported, treatment will continue until PD, unacceptable toxicity or death."
15867870|NCT03898908|Drug|binimetinib|Binimetinib 15mg (tablets) for a 45mg/12 hours for oral administration during 56 days and after local radiation treatment.
15867871|NCT03898908|Radiation|Whole brain radiation therapy|"The whole brain planning target volume (PTV) will receive 30 Gy in 10 fractions.
~Treatment will be delivered once daily, 5 fractions per week, over 2 to 2.5 weeks."
15867872|NCT03898908|Radiation|Radiosurgery/stereotactic radiosurgery|"Dose selection must be based on previously published Radiation Therapy Oncology Group (RTOG) data, with dose modification left up to the treating physician. The total dose will depend on the size of the metastatic lesion(s) and proximity to critical structures.
~Suggested doses are as follow: 1 fraction x 15-25 Gy; 3 fractions x 9-11 Gy; 5 fractions x 6-7 Gy; or 6 fractions x 5-6 Gy.
~For GTV > 20 mm hypofractionated stereotactic radiotherapy could be preferred. Treatment will be delivered once daily, alternate-day, 3 fractions per week."
15867873|NCT03898895|Combination Product|Radiotherapy+anti-PD-1|The total radiation dose is over 40Gy without damaging organic fucntion. Conventional intensity-modulated radiotherapy or stereotactic body radiation therapy are both allowed. Camrelizumab 200mg intravenously every 3 weeks will be initiated within 7 days after radiotherapy. Patients will receive camrelizumab until clinical or radiographic disease progression, unacceptable toxicity, death, termination of the study or withdrawal. If disease progression is confirmed by radiologic examinations, another 200mg camrelizumab should be applied to the patient, then another radiologic examination will be performed 4 weeks later to confirm or exclude progression. If progression is confirmed, the camrelizumab should be stopped.
15867874|NCT03898895|Drug|Gemcitabine+cisplatin|Cisplatin 25mg/m2 intravenously (day 1 and day 8) and then gemcitabine 1000mg/m2 intravenously (day 1 and day 8) every 3 weeks (1 cycle), for 8 cycles.
15867875|NCT03898882|Drug|oxytocin|PK measurements of oxytocin
15867876|NCT03898882|Device|Shore durometer|The investigators will take serial readings from a digital durometer at the uterine fundus at 3, 6, 9 and 12 minutes following OXT administration to provide data that will inform an estimate of the timing of peak effect. Shore durometers measure the hardness of materials on a scale of 0-100 Shore Units (SU). Preliminary (unpublished) data provided a range of 10-56 SU after oxytocin administration at cesarean delivery. Durometer readings were also shown to correlate positively with the obstetrician's manual assessment of uterine contractility, which is traditionally used to determine the success or failure of uterotonic therapy.
15867877|NCT03898869|Diagnostic Test|Intraoperative NIRS monitoring|Near infrared spectroscopy non invasively used to register changes in tissue oxygen amount during endovascular revascularization
15867878|NCT03898856|Drug|Crofelemer|125 mg tablets taken by mouth twice daily for 28 days
15867879|NCT03898856|Diagnostic Test|Diagnostic tests for cause of chronic diarrhea|Diagnostic tests include: Esophagogastroduodenoscopy, Colonoscopy, biopsies of the upper gastrointestinal tract (duodenum) and lower gastrointestinal tract (colon), genetic testing for Congenital sucrase-isomaltase deficiency (CSID),Prometheus IBcause Chronic Diarrhea panel, Thyroid Panel, Stool osmolality, Stool Ova and Parasites, Stool Culture, Stool Qualitative Stool Fat, Stool Reducing Substances, Laxative Screening, Lactulose Hydrogen Breath Test, Gastrin Level, Calcitonin Level, Vasoactive Intestinal Polypeptide(VIP) level.
15867880|NCT03898843|Other|Animal assisted therapy|Patients of AAT group will leave their hospital bedroom to go in the session room, where they will meet a dog, who has come with his veterinary student master. Animal assisted therapy session will last at most 20 minutes, in which the patient is going to interact with the dog, pet him, play with him, etc.
15867881|NCT03898843|Biological|Nasal swab sampling|All patients will have nasal swab sampling at inclusion and 7 days after AAT session or sham session in order to screen multidrug resistant bacteria
15867882|NCT03898843|Behavioral|STAI-Y and POMS Questionnaires|Before and after AAT or sham session, patients will answer State-Trait Anxiety Inventory Y (STAI-Y), Profile of Mood States (POMS) questionnaires.
15867883|NCT03898843|Procedure|physiological parameters measure|Before and after AAT or sham session, blood pressure, heart rate dans respiratory rate will be measured.
15867884|NCT03898843|Other|Visual Analog Scale (VAS)|Before and after AAT or sham session, pain will be evaluated thanks to VAS
15867885|NCT03898843|Behavioral|Impact of Event Scale - Revised (IES-R)|Patients will answer IES-R questionnaire 3 months after AAT or sham session
15867886|NCT03898843|Behavioral|satisfaction questionnaire|Patients of the AAT group will answer satisfaction questionnaire at the end of the AAT session and 3 months after AAT
15867887|NCT03898843|Biological|Rectal swab sampling|All patients will have rectal swab sampling at inclusion and 7 days after AAT session or sham session in order to screen multidrug resistant bacteria
15867888|NCT03898830|Device|eon™ FR 1064 nm device|The subject treatment area - abdomen, was treated with the 1064 nm wavelength laser.
15867889|NCT03898817|Other|taking of cutaneous cells|Taking of cutaneous cells by biopsy Sample of blood
15867890|NCT03898804|Device|BCI and FES|The intervention consists of surgical implantation of the device components, BCI and FES that will interface with computers that process and decode neural information, compute stimulation parameters, and control communication between the device components. The device will be tested during research sessions spanning a 13-month period.
15867891|NCT03898791|Drug|LY3295668 Erbumine|oral capsules
15867892|NCT03898765|Diagnostic Test|Dry blood spot screening|Dry blood spot measurement of biomarker for screening biliary atresia
15867893|NCT03898752|Dietary Supplement|Omega 3|Omega 3: 1g daily for 3 months CoQ10: 100 mg daily for 3 months Multivitamin: 1 normal multivitamin tablet daily for 3 months
15867894|NCT03898739|Other|Cervical Traction from different angles|Intermittent traction will be applied, maximum force will be 16 kg, minimum force will be 12 kg, traction cycle of each minute consists of 20 seconds static traction at the maximum force then released down to the minimum force for 20 seconds then repeated for 20 seconds static traction. Traction session time will be 15 minutes, and the traction force will be increased progressively with speed (50%) of increment of force
15867895|NCT03898726|Biological|laparoscopical l cuff closure|closure of vaginal cuff following hysterectomy
15867896|NCT03898713|Diagnostic Test|Intelligence quotient|intelligence quotient (IQ) is a total score derived from several standardized tests designed to assess human intelligence
15867897|NCT03898700|Behavioral|strength based coaching|strength based and solution focused coaching
15867898|NCT03898687|Device|SLN Biopsy with Magtrace®/Sentimag®|Identification of SLN by means of Magtrace®/Sentimag® and SPIO-MRI
15867899|NCT03898674|Drug|Intra venous fluid|Volume of intra venous fluid administered during GDT protocol
15867900|NCT03898661|Drug|Collagenase histiolyticum|local injection of collagenase histiolyticum into the esophageal stricture, 1 day before balloon dilation
15867901|NCT03898648|Other|Waiting room task|"The waiting room task consists in a computerized neuropsychological task in which the participant is asked to freely choose a chair to sit in a waiting room. In a row of four chairs, the two in the middle are occupied by two males or females. One of the two subjects sitting either has a neutral face, or express a negative emotion (fear or anger).
~To make their decision, participants must press the S keyboard button to go left or the L keyboard button to go right in a time limit of 1500 milliseconds.
~One third of the time, the cursor moves in the opposite direction to that requested by the participant. For example, if the subject presses S, the cursor moves to the right instead of to the left.
~Those reverse trials are used to evaluate their motivation to correct the movement of the cursor.
~The participant will repeat the task 360 times for the assessment to be completed."
15867902|NCT03898635|Drug|Linezolid|To add linezolid 600mg or 1200mg daily in the initial or subsequent treatment regimen of TBM.
15867903|NCT03898622|Drug|Levothyroxine|levothyroxine with a safe dose for our population with high cardiovascular risk of 0.25mcg so that the patient's weight range between 50-80kg maintains a dosage of 0.3-0.5mcg / kg / day that does not affect the thyroid axis) fasting levothyroxine (in the case of taking a drug that interacts with absorption, use of it is changed according to the specified hours, see Table 2), and adjusted according to TSH levels > 1 and normal T4L
15867904|NCT03898609|Other|Dietary intervention|3 weeks
15867905|NCT03898596|Diagnostic Test|ECG|An ECG collects superficial readings of heart activity
15867906|NCT03898583|Drug|Microarray patch A|Microarray patch
15867907|NCT03898583|Drug|Microarray patch B|Microarray patch
15867908|NCT03898583|Drug|Placebo|Microarray patch vehicle
15867909|NCT03898583|Drug|Daivobet|Daivobet Gel
15867910|NCT03898570|Behavioral|Patient reported outcomes|"Patients will download the research app onto their phone and enter pertinent medical history and surgical history data similar to standard registries for specific procedures. Over the next 12 months the investigators will obtain patient-reported outcomes (PROs) using the patient's phone.
~Specifically, the investigators will obtain daily activity data, weekly 6-minute-walk tests, and quarterly quality of life surveys"
15867911|NCT03898557|Behavioral|Provision of HIV self-test with Commitment and planning prompts|The interventions will use behavioral interventions such as commitment and planning prompts to increase the update of HIV self-testing
15867912|NCT03898557|Behavioral|Provision of HIV self-test|This arm will receive a HIV self-test
15867913|NCT03898544|Device|Group primary TKA|"Assessment by gait kinematics analysis The total knee arthroplasty will be performed as usual with the dedicated instrumentation.
~The gait kinematics analysis will be performed with the KneeKG system on a treadmill, with infrared sensors (IR) on the leg. This system is not invasive. The IR sensors are positioned on the pelvis, the distal femur and the tibial crest. This system records the flexion/extension, the varus/valgus and the rotation during the walking (1 minute of walking)."
15867914|NCT03898544|Device|Group TKA revision|"Assessment by gait kinematics analysis The total knee arthroplasty will be performed as usual with the dedicated instrumentation.
~The gait kinematics analysis will be performed with the KneeKG system on a treadmill, with infrared sensors on the leg. This system is not invasive. The IR sensors are positioned on the pelvis, the distal femur and the tibial crest. This system records the flexion/extension, the varus/valgus and the rotation during the walking (1 minute of walking)."
15868456|NCT03894111|Other|decesased patients|mortality ratio
15867915|NCT03898531|Procedure|hip prosthesis removed metal / polyethylene, simple mobility|"Patients are hospitalized in order to change their hip prosthesis at the hospital la Croix-Rousse in Lyon.
~Patients have to complete before the surgery a survey on occupational and environmental exposures to mineral dust.
~The prosthesis removed is composed by metal/polyethylene. It's a simple mobility The aim is to define the types of particles that cause the most tissue inflammation"
15867916|NCT03898531|Procedure|hip prosthesis removed metal / polyethylene, double mobility|"Patients are hospitalized in order to change their hip prosthesis at the hospital la Croix-Rousse in Lyon.
~Patients have to complete before the surgery a survey on occupational and environmental exposures to mineral dust.
~The prosthesis removed is composed by metal/polyethylene. It's a double mobility.
~The aim is to define the types of particles that cause the most tissue inflammation"
15867917|NCT03898531|Procedure|hip prosthesis removed ceramic/ polyethylene, simple mobility|"Patients are hospitalized in order to change for their hip prosthesis at the hospital la Croix-Rousse in Lyon.
~Patients have to complete before the surgery a survey on occupational and environmental exposures to mineral dust.
~The prosthesis removed is composed by ceramic/polyethylene. It's a simple mobility.
~The aim is to define the types of particles that cause the most tissue inflammation"
15867918|NCT03898531|Procedure|hip prosthesis removed ceramic/ polyethylene, double mobility|"Patients are hospitalized in order to change their hip prosthesis at the hospital la Croix-Rousse in Lyon.
~Patients have to complete before the surgery a survey on occupational and environmental exposures to mineral dust.
~The prosthesis removed is composed by ceramic/polyethylene. It's a double mobility.
~The aim is to define the types of particles that cause the most tissue inflammation."
15867919|NCT03898531|Procedure|Primary implanted hip prosthesis|"Patients are hospitalized in order to have a first hip prosthesis at the hospital la Croix-Rousse in Lyon.
~Patients have to complete before the surgery a survey on occupational and environmental exposures to mineral dust.
~The patients will be received a first prosthesis."
15867920|NCT03898531|Procedure|hip prosthesis removed metal/metal|"Patients are hospitalized in order to change their hip prosthesis at the hospital la Croix-Rousse in Lyon.
~Patients have to complete before the surgery a survey on occupational and environmental exposures to mineral dust.
~The prosthesis removed is composed by metal/metal. The aim is to define the types of particles that cause the most tissue inflammation"
15867921|NCT03898531|Procedure|hip prosthesis removed ceramic/ceramic|"Patients are hospitalized in order to change their hip prosthesis at the hospital la Croix-Rousse in Lyon.
~Patients have to complete before the surgery a survey on occupational and environmental exposures to mineral dust.
~The prosthesis removed is composed by ceramic/ceramic. The aim is to define the types of particles that cause the most tissue inflammation"
15867922|NCT03898518|Other|12-week jump rope exercise program|Each jump rope exercise session of the program was performed for 50 minute, with a 5 minute warm-up and cool-down. Sessions were performed once a day, 5 days a week, for 12 weeks. The program consisted of various main jump rope exercises (1 line 2 jump, jumping feet together, running jumping, open side jump, open back and forth jump, rock paper scissor jump). The warm-up and cool-down consisted of static stretching, walking, and jogging. Intensity of exercise was gradually increased form 40-50% heart rate reserve (HRR) in weeks 1-4 and 60-70% HRR in weeks 9-12. Each training session was supervised by the researchers. Ever subject wore a heart rate monitor during the whole training session in order to maintain the designated training intensity.
15867923|NCT03898505|Dietary Supplement|AvoMax (Low Dose)|AvoMax (Low Dose) is a natural spray-dried avocado powder, which contains 50 mg of a combination of bioactive polyhydroxylated fatty alcohols (PFAs), avocadyne and avocadene.
15867924|NCT03898505|Dietary Supplement|AvoMax (High Dose)|AvoMax (High Dose) is a natural spray-dried avocado powder, which contains a total of 200 mg of a combination of bioactive polyhydroxylated fatty alcohols (PFAs), avocadyne and avocadene.
15867925|NCT03898505|Other|Placebo|Placebo product is powder containing only non-medicinal ingredients used in the test product: Oryza sativa (rice) bran extract (65-70% w/w of total placebo formulation), sodium bicarbonate, rosemary extract, xylitol, silicon dioxide, microcrystalline cellulose, rice hull powder, strawberry flavour.
15867926|NCT03898492|Other|Physical training|Training two times/week for an hour each time in 8 weeks. The training included strength training, aerobic training, balance training and flexibility training. The training was modified to the participants and initiated by the staff at the center.
15867928|NCT03898466|Drug|Fluticasone furoate|Inhaled corticosteroid
15867929|NCT03898466|Other|Matching placebo|Placebo inhaler
15867930|NCT03898453|Behavioral|EMDR psychotherapy|Visit 0 : patient inclusion (questionnaires and interview) Visit 1 : anamnesis Visit 2 : patient stabilisation Visit 3 : EMDR psychotherapy care Visit 4 : EMDR psychotherapy care Visit 5 : EMDR psychotherapy care and questionnaires Visit 6 : EMDR psychotherapy care Visit 7 : EMDR psychotherapy care and questionnaires Follow-up 8 (three month after) : data recovery (questionnaires) Follow-up 9 (six month after) : data recovery (questionnaires)
15867931|NCT03898453|Behavioral|support psychotherapy|"Visit 0 : patient inclusion (questionnaires and interview) Visits 1-7: several methods could be used: psychoeducation about cancer and psychotherapy, positive interaction and activity schedule, emotional support , relaxation, prevention techniques… Questionnaires will be completed by patients at visit 5 and 7.
~Follow-up 8 (one month after) : data recovery (questionnaires) Follow-up 9 (six month after) : data recovery (questionnaires)"
15867932|NCT03898427|Device|Wrist Actigraphy Devices|A watch-like wearable sensor
15867933|NCT03898427|Device|Polysomnography|Sleep Monitor
15867934|NCT03898427|Device|Videography|Thermal Camera
15867935|NCT03898401|Combination Product|Platelet rich plasma|After isolation of the PRP, calcium chloride (0.5ml) was added to the 5 ml of PRP isolate to activate the thrombin cascade, thereby causing degranulation of platelets, releasing growth factors and cytokines, and starting the transformation of the PRP to platelet rich fibrin matrix (PRFM) Before the PRFM became too gelatinous for passing through a needle (less than 10 minutes), two injections will be given through a 27-gauge needle in the posterior vaginal wall and perform clinical evaluations at 0, 1, 3, and 6 months.
15867936|NCT03898388|Procedure|Bone Marrow Concentrate treatment|Correlate patient outcomes 6 months after receiving the Regenexx SD treatment with measurements of synovial fluid collected before treatment
15868032|NCT03897621|Drug|Placebo|Patients in the placebo group will receive normal saline (a bolus of sodium chloride 0.9%, 0.1 mL/kg or maximal dose of 10 mL).
15867937|NCT03898375|Other|Walking with different optic flow speeds|Patients will perform 4 sessions of 20 minutes treadmill walking: one control session without VR and 3 walking sessions with the VR. In each VR session, patients will walk with a different optic flow speed: the same as, faster than or slower than their walking speed.
15867938|NCT03898362|Other|pneumatically powered wheelchair or scooter|a wheelchair or scooter powered by compressed air will be used for 6 months. Compressed air is a novel power source and no batteries are used in these devices.
15867939|NCT03898362|Device|battery powered wheelchair or scooter|a wheelchair or scooter powered by a battery will be used for 6 months. These are conventional mobility devices that the participants are using or in the process of obtaining
15867940|NCT03898349|Other|Annie text messaging system|Annie text messaging system for patient self-management of HCV treatment including medication, lab, and appointment reminders, and motivational messages.
15867941|NCT03898349|Other|Annie text messaging system with Usual implementation|"Three comparison sites received usual implementation of the automated text messaging system Annie only, which involves an orientation/training meeting and the option of attending twice-monthly Annie clinical adoption calls"
15867942|NCT03898349|Other|Annie text messaging system with Augmented implementation|"Four facilities received the automated text messaging system Annie and our augmented implementation strategy. These facilities had regular facilitation calls, a site visit to assist with implementation, and were given the toolkit, in addition to receiving usual implementation assistance"
15867943|NCT03898336|Other|broad-spectrum micronutrient|daily intake of capsules containing a blend of Vitamin B3 (NADH), Vitamin B6 (pyridoxal-5-phosphate), folic acid (5-MTHF), Vitamin B12 (methylcobalamin), Vitamin D3 (25-hydroxyvitamin D3), Magnesium (magnesium oxide), Zinc (zinc methionine), Iron (ferric phosphate), Selenium (selenomethionine), Phospholipids, L-carnitine (L-carnitine-L-tartrate)
15867944|NCT03898336|Other|placebo|daily intake of capsules
15867945|NCT03898323|Device|Alcohol Approach Bias Modification|Computerized training
15867946|NCT03898310|Dietary Supplement|Cranberry extract capsules|Participants in the treatment arm will receive cranberry extract capsules.
15867947|NCT03898310|Dietary Supplement|Placebo capsule|Participants in the placebo arm will receive placebo capsules.
15867948|NCT03898297|Radiation|[18F]FPEB|Radiotracer: [18F]FPEB
15867949|NCT03898297|Radiation|[11C]APP311|Radiotracer: [11C]APP311, [11C]UCB-J
15867950|NCT03898284|Diagnostic Test|Impulse Oscillometry|Impulse Oscillometry will be performed in addition to usual care
15867951|NCT03898271|Other|Virtual World|Participants will complete a synchronous PTSD training in an immersive virtual world environment.
15867952|NCT03898258|Other|Qualiveen full version|Qualiveen full version questionnaire with 40 questions for assessing the quality of life in relation to bladder dysfunction in persons with neurogenic bladder
15867953|NCT03898258|Other|Qualiveen short-form|Qualiveen short-form questionnaire with 8 questions for assessing the quality of life in relation to bladder dysfunction in persons with neurogenic bladder
15867954|NCT03898245|Device|apply tDCS|Intensity 2mA, 20minues, 4 times (post operation in 30min, in 4hrs, next day morning and next day afternoon) anodal tDCS applied over the left DLPFC cathodal tDCS applied over the right DLPFC
15867955|NCT03898245|Device|Sham tDCS|Intensity 0mA, 40 seconds, 4 times (post operation in 30min, in 4hrs, next day morning and next day afternoon) anodal tDCS applied over the left DLPFC cathodal tDCS applied over the right DLPFC
15867956|NCT03898232|Radiation|Computed Tomography (CT) Scan of the Lumbar Spine|Patients in the cohort who have not received a 12 month post-op CT scan will be asked to enroll in the study and undergo a CT of the lumbar spine.
15867957|NCT03898206|Other|Breaking up sitting with walking breaks|See Breaking up sitting with walking breaks arm description
15867958|NCT03898206|Other|Prolonged sitting|See Prolonged sitting arm description
15867959|NCT03898193|Drug|Montelukast|Montelukast, 5 mg Chewable Tablets, manufactured by Pharmtechnology LLC, Republic of Belarus
15867960|NCT03898193|Drug|Singulair|Singulair, 5 mg Chewable Tablets, marketed by Merck Sharp & Dohme B.V., the Netherlands
15867964|NCT03898167|Behavioral|Telephone Recall|Participants receive a scripted telephone recall from a trained patient navigator.
15867965|NCT03898167|Behavioral|Mailed HPV Self-Sampling Kit|Participants receive a mailed kit that allows them to self-collect a cervical sample in their home and return it to a laboratory for human papillomavirus (HPV) testing.
15867966|NCT03898167|Behavioral|Patient Navigation|Participant receives telephone call from patient navigator within 3-5 days of receipt of self-collection kit. Patient navigator provides one-on-one education on cervical cancer screening and self-collection of cervical sample.
15867969|NCT03898141|Other|Placebo (PL)|"Participants will get deceptive and receive an inert cream (=placebo intervention) that reduces pain."
15867970|NCT03898141|Other|Dog only (DO)|In the dog intervention a dog will be present during the second measurements. However, participants will only learn the true aims of the presence of the dog after the study (delayed informed consent).
15867971|NCT03898141|Other|Animal-assisted placebo (AAPL)|Participants receive the placebo intervention in the presence of a dog.
15867972|NCT03898128|Drug|Anti-CD22 Immunotoxin|Clinical data (treatment, survival, adverse events) of patients treated with anti-CD22 immunoconjugates from 2014 will be collected
15867973|NCT03898115|Behavioral|CHG Education|"The CHG educational intervention will include educational outreach and audit and feedback implementation strategies"
15867974|NCT03898102|Drug|Regorafenib|regorafenib plus zinc gluconate
15867975|NCT03898102|Dietary Supplement|Zinc gluconate supplement|Zinc gluconate supplement
15868457|NCT03894098|Procedure|Nerve block|High ankle nerve block
15867976|NCT03898089|Other|Core Stability Exercise|The participants in the core stability exercise group will be included in a treatment program for 3 days per week for 6 weeks. Traditional physiotherapy methods will be applied to all participants. Traditional physiotherapy will include heat modality (a hot pack for 15 minutes), electrotherapy (transcutaneous electrical nerve stimulation (TENS), a 50 Hz conventional TENS with a pulse duration <150 microseconds).Each training session will be lasted 60 min, starting with a 10-min warm up program mainly consisting of core strength exercises and ending with a 5-min cool-down program (stretching). Progression of exercises will be tailored to individual patients' ability, fatigue and pain. Exercises will be designed from 1 set to 3 sets, from 8 to 15 repetitions and contractions from 5 seconds to 10 seconds.
15867977|NCT03898089|Other|Core Stability Exercise plus Myofascial Release Technique Group|In addition to the core stabilization exercise group myofascial relaxation technique will be performed with roller massager (Theraband®, The Hygenic Corporation, Akron, OH.) for 3 days per week for 6 weeks. The myofascial relaxation technique will be performed along the superficial back line (plantar fascia gastrocnemius muscles, hamstring muscles, sacrolumbar fascia, erector spinae muscles) bilaterally. Myofascial relaxation will be done to the anatomical structures indicated by roller massage technique. Applications will be made in 3 sets of 30sec for each zone (1 min rest between sets) and 7/10 according to VAS.
15867978|NCT03898076|Device|Flash Glucose Monitoring|Continuous Glucose Monitoring (CGM) values will be downloaded from CGM device for a period of 90 days.
15867979|NCT03898076|Other|A1c|A1c levels will be collected from Hospital EMR prior to CGM data downoad
15867980|NCT03898076|Other|Predictive A1c|Predictive A1c will be calculated based on the first 15 days of CGM data using time in range (TIR), coefficient of variation (CV), mean amplitude of glycemic excursion (MAGE), mean of daily differences (MODD), continuous overall net glycemic action (CONGA). Predictive A1c will be correlated with actual A1c.
15867981|NCT03898063|Behavioral|90 DAYS film|the intervention conditions include exposure to a film, 90 DAYS (approx 20 minutes long), an entertainment film detailing a woman's decision to tell her romantic partner that she is HIV-positive.
15867982|NCT03898063|Behavioral|HIV pamphlet on disclosure|A standard-of-care brochure given to newly diagnosed HIV patients about the importance of status disclosure
15867983|NCT03898050|Procedure|transcutaneous cardiac pacing|transcutaneous cardiac pacing
15867984|NCT03898037|Behavioral|weight loss intervention|weight loss intervention under the guidance of a dietitian, including: restricted energy balanced diet, aerobic exercise, etc.
15867985|NCT03898037|Drug|metformin intervention|metformin intervention with a starting dose of 0.5g bid, and the dose will be adjusted by doctors according to the patient's insulin level and adverse events.
15867986|NCT03898024|Drug|SHR-1222|Pharmaceutical form: water injection; Route of administration: subcutaneous
15867987|NCT03898024|Drug|Placebo|Pharmaceutical form: water injection; Route of administration: subcutaneous
15867988|NCT03898011|Drug|Lamotrigine|Lamotrigine, 100 mg Tablets, manufactured by Pharmtechnology LLC, Belarus
15867989|NCT03898011|Drug|Lamictal|Lamictal®, 100 mg Tablets, marketed by GlaxoSmithKline Trading CJSC, Russia
15867990|NCT03897998|Drug|Naloxone|"4mg of Naloxone will be administered (0.1 mL of 40 mg/ml naloxone solution given intranasally).
~A random allocation sequence will be independently generated by the UM Pharmacy. The Principal investigator will call for each experiment."
15867991|NCT03897998|Other|Saline|"Intranasal Normal Saline (0.1 mL 0.9% sodium chloride) will be administered shortly before beginning the fMRI experiment.
~A random allocation sequence will be independently generated by the UM Pharmacy. The Principal investigator will call for each experiment."
15867992|NCT03897985|Device|Narcotrend TM|Measurement of anesthesia depth
15867993|NCT03897972|Behavioral|Non-personalised diet advice delivered via the eNutri app (control)|Non-personalised dietary advice to improve food choices based on standard population guidelines delivered by the eNutri app and irrespective of the dietary intakes from the food frequency questionnaire (control group).
15867994|NCT03897972|Behavioral|Personalised diet advice delivered via the eNutri app (intervention)|Personalised dietary advice to improve food choices based on adherence to an 11-item diet quality score, which is determined by the eNutri app in response to the dietary intakes from the food frequency questionnaire (intervention group).
15867995|NCT03897959|Device|Kohli vs Foley catheter|Alternative suprapubic catheter used for bladder drainage.
15867996|NCT03897946|Biological|Birth dose hepatitis B vaccine|Groups A and C will receive a birth dose of hepatitis B vaccine within 24 hours of life.
15867997|NCT03897933|Procedure|Erector Spinae Plane block ( Group I)|ESP Block was performed preoperative to all patients in ESP block group. Patients in all groups were provided with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.
15867998|NCT03897933|Procedure|non- blocked Group (GROUP II)|This group was received no intervetion. Patients in all groups were provided with intravenous patient- controlled analgesia device containing morphine for postoperative analgesia.
15867999|NCT03897920|Other|Doppler ultrasound assessment of renal arteria resistive index|A high frequency probe will be used together with the use of color or power Doppler to help vessel localization. As resistance to blood flow progressively increases from the hilar arteries toward the more peripheral parenchymal vessels, renal arteria resistive index (RRI) will be done at the level of the arcuate or interlobar arteries, adjacent to medullary pyramids. Measurements will be repeated in different parts of both organs (superior, median, and lower) when at least three reproducible waveforms have been obtained. An RRI will be calculated with the following formula: (peak systolic velocity - end diastolic velocity)/peak systolic velocity, and the mean value of three measurements at each kidney is usually considered. An RRI value 0.60 ± 0.01 (mean ± SD) is usually taken as normal with a value of 0.70 being considered the upper normal threshold
15868000|NCT03897907|Other|Psychologically Informed Education Video|"The education session will teach participants how the body processes nociception and experiences pain, and pain does not mean tissues are being damaged. Additionally we will use the framework called the Common Sense Model of Self-Regulation which advocates for education to address five cognitive dimensions: (1) identity (the effort to evaluate symptoms and label the illness); (2) cause (the subjectively formulated belief of what is causing the symptoms); (3) time-line (the patient's perception of how long the problem will last); (4) consequences (the patient's predictions of how the illness will affect them in different areas of their life); and (5) controllability (the patient's belief regarding their outcome and personal ability to change it)"
15868001|NCT03897907|Other|Anatomy Education Video|Participants in the control education group will watch a video on the iPad equal in length to the psychologically informed education video. The control video will discuss basic anatomy of the knee and provide no psychosocial education or positive reinforcement about their condition.
15868002|NCT03897894|Behavioral|Child Friendly Space|Child Friendly Spaces (CFS) are one of the most widely used interventions to provide Mental Health and Psychosocial Support (MHPSS) as well as provide a protective environment for children in humanitarian settings.
15868003|NCT03897881|Biological|mRNA-4157|Personalized cancer vaccine
15868004|NCT03897881|Biological|Pembrolizumab|Intravenous infusion
15868005|NCT03897868|Drug|HCP1803|HCP1803
15868006|NCT03897868|Drug|Amlodipine|Amlodipine
15868007|NCT03897868|Drug|Losartan|Losartan
15868008|NCT03897868|Drug|Placebo|Placebo
15868009|NCT03897855|Other|Post Traumatic Stress Disorder|"The test Think / No-Think"
15868010|NCT03897842|Device|Reprieve Cardiovascular System|The Reprieve Cardiovascular System (RCS) shall be utilized to maximize fluid removal over a maximum duration of 72 hours.
15868011|NCT03897803|Diagnostic Test|strain elastography|strain elastography as apart of muscle ultrasound examination of the biceps brachii and rectus femoris muscles will be performed to the patients and control groups at baseline evaluation and after 4 months follow up in the patients groups only.
15868012|NCT03897790|Other|Transcranial Doppler (DTC)|Evaluation of Vasoconstrictor Vasoreactivity with Transcranial Doppler
15868013|NCT03897777|Behavioral|Exercise Training effect on Hypertension and Gut Dysbiosis|the proposed research will: 1) Characterize gut microbial community structure in AA with hypertension in two important compartments that make up the overall gut bacteria in the colon (fecal and colon mucosa); 2) Quantify the relationship between aerobic exercise training and gut bacteria to identify SCFA microbes that adapt to exercise and benefit BP.
15868014|NCT03897764|Procedure|Intraoperative superior hypogastric plexus block|SHP is situated anterior to L5-S1 vertebral bodies, caudal to the bifurcation of the aorta. An injection of 20 ml of bupivacaine 2,5 mg/ml or saline 9 mg/ml was done retroperitoneally in the area.
15868015|NCT03897738|Dietary Supplement|Amberen|Amberen is a succinate-based dietary supplement previously shown to help provide relief for common menopausal symptoms.
15868016|NCT03897738|Dietary Supplement|Smart B|Smart B contains vitamins B1, B2, B6, B9, B12 and sodium fumarate.
15868017|NCT03897738|Dietary Supplement|Placebo|Placebo capsules are identical to Amberen and Smart B capsules.
15868018|NCT03897725|Other|Telehealth Coaching|Telehealth coaching to promote adherence
15868019|NCT03897699|Device|Transcranial Direct Current Stimulation|A non-invasive neuromodulation technique that can modulate neural activity. Weak electrical current (~2mA) is applied to the scalp using anodal and cathodal electrode sponges, which increase or decrease cortical excitability respectively.
15868020|NCT03897699|Behavioral|Mindful Breathing|MBT is a mindfulness-based intervention that guides participants to pay attention to the present experience. Participants will be trained to become aware of mind-wandering, disengage, and shift attention back to the present experience. Participants will practice mindful breathing using a computerized application that they will be able to access on the web.
15868021|NCT03897699|Other|Sham|Weak electrical current (~2mA) is applied to the scalp using anodal and cathodal electrode sponges, which increase or decrease cortical excitability respectively. Sham stimulation will serve as a control condition with current applied only for the first and last 30 seconds of the 20-minute session.
15868022|NCT03897686|Device|"hydrous biopolymer with silver ions Argiform"|4.0 ml for one injection with one-week interval between injections. Course - 2 injections.
15868023|NCT03897686|Device|saline solution|4.0 ml for one injection with one-week interval between injections. Course - 2 injections.
15868024|NCT03897673|Dietary Supplement|Early Iron|iron syrup for the first three months (84 days) and placebo syrup for the fourth month
15868025|NCT03897673|Dietary Supplement|Delayed Iron|placebo syrup for the first month (28 days) and iron syrup for the second, third, and fourth months
15868026|NCT03897660|Dietary Supplement|Omega-3 + vitamin K2 (TG form of omega-3)|"The intervention is a randomized double bond cross over design testing the pharmacokinetics of a monoglyceride formulation compared to a triglyceride and an ethyl ester form.
~Treatments are randomly assigned on days 0, 7 and 14 of the clinical study. Blood samples will be collected at time 0, 1, 2, 4, 5, 6, 8, 9, 10, 12 and 24 hours. Each participant will perform all three treatments, with a minimum of 6 days between treatments. A questionnaire will document the side effects felt by participants during the omega-3 supplement taking day."
15868027|NCT03897660|Dietary Supplement|Omega-3 + vitamin K2 (EE form of omega-3)|"The intervention is a randomized double bond cross over design testing the pharmacokinetics of a monoglyceride formulation compared to a triglyceride and an ethyl ester form.
~Treatments are randomly assigned on days 0, 7 and 14 of the clinical study. Blood samples will be collected at time 0, 1, 2, 4, 5, 6, 8, 9, 10, 12 and 24 hours. Each participant will perform all three treatments, with a minimum of 6 days between treatments. A questionnaire will document the side effects felt by participants during the omega-3 supplement taking day."
15868028|NCT03897660|Dietary Supplement|Omega-3 + vitamin K2 [MaxSimil (MAG form of omega-3)]|"The intervention is a randomized double blind cross over design testing the pharmacokinetics of a monoglyceride formulation compared to a triglyceride and an ethyl ester form.
~Treatments are randomly assigned on days 0, 7 and 14 of the clinical study. Blood samples will be collected at time 0, 1, 2, 4, 5, 6, 8, 9, 10, 12 and 24 hours. Each participant will perform all three treatments, with a minimum of 6 days between treatments. At each blood draw time points, a questionnaire will be administered to the particpant to monitor if they experiencec side effects with the dietary supplement they ingested in the morning."
15868029|NCT03897647|Device|General Electric (GE) VScan|This is a small, point-of-care, hand-held device used for ultrasound (POCUS). It uses sound waves to generate images without using any radiation.
15868030|NCT03897634|Device|Remote Microphone|Experienced hearing aid users will be trained on and use a remote microphone for 30 days. Pre- and Post- measures will be taken to determine benefit. Participant characteristics will also be assessed (such as self-efficacy) to explore personality factors that may contribute to benefit from devices.
15868031|NCT03897621|Drug|Tranexamic Acid|tranexamic acid will be administered intravenously after induction of anesthesia (a bolus of 10 mg/kg or maximal dose of 1g).
15868767|NCT03891862|Drug|Placebo oral capsule|non-active dosage form
15868033|NCT03897608|Behavioral|short form 36|"The Short Form (SF)-36 Health Survey was used to measure HRQL. The SF-36 generates a profile of HRQL outcomes by measuring health across eight different dimensions: physical functioning, role limitation because of physical health, social functioning, vitality, bodily pain, mental health, role limitation because of emotional problems and general health. Responses to each question within a dimension are combined to generate a score from 0to100; where100 indicates good health"
15868035|NCT03897569|Other|frontal projection angle, ankle dorsiflexion|Dorsiflexion measurements will be taken in 4 different positions and repeated and recorded 3 times in each position, Prone bent, straight knee and Standing bent, straight knee. Prior to the measurement, the participants completed two 30-second calf stretches The FPPA was determined as the angle at the knee formed by lines connecting the anterior superior iliac spine, the midpoint of the femoral condyles and the midpoint of the malleoli at the deepest part of the squat
15868036|NCT03897556|Dietary Supplement|Guarana herb|The intervention is a functional food bar produced in a licensed commercial kitchen that contains guarana powder as well as dates, raisins, oats, spirulina, walnuts, flour, coconut butter, soybean oil, xanthan gum and chocolate chips.
15868037|NCT03897556|Other|Usual Care|Participant will receive 'usual-care' for cancer survivors. At the end of the study, after completing the Final Visit, they will receive 21 guarana energy bars to thank them for being in the study.
15868038|NCT03897543|Drug|ABX196|ABX196 will be administered as an IM injection 120 minutes (+/- 15 minutes) after the completion of the nivolumab infusion on Day 1 of every other 28-Day treatment cycle (i.e., every 8 weeks).
15868039|NCT03897530|Behavioral|Smoking Cessation Intervention|View and purchase hypothetical tobacco products during four distinctly different ETM
15868040|NCT03897530|Other|Functional Assessment|Visual attention is evaluated via eye-tracking equipment
15868041|NCT03897530|Other|Questionnaire Administration|Ancillary studies
15868042|NCT03897517|Dietary Supplement|Proprietary Botanical Blend|Oral administration of capsules containing proprietary botanical blend 30 minutes prior to carbohydrate ingestion.
15868043|NCT03897517|Dietary Supplement|Placebo|Oral administration of capsules containing rice flour (placebo) 30 minutes prior to carbohydrate ingestion.
15868044|NCT03897504|Procedure|feminizing genitoplasty using inner surface of the prepuce as pedicled tubularized flap|the prepuce of the females with congenital adrenal hyperplasia will be tubularized and used as pedicled flap in creating the new vagina, the urethra will be completed with the urogenital sinus, no mobilization either partial or complete urogenital mobilization will be needed in cases with low and intermediate confluence level (less than 30 mm), in case with high confluence (more than 30 mm) laparoscopic vaginal pullthrough will be attempted first then the same previously described technique will be applied, the depth of the confluence will be determined before starting surgery by doing genitograph under general anaesthesia, stent will be kept in the new vagina for 5 days and further scheduled calibrations and dilatations will be applied regularly with paying attention to urinary complications like incontinence and urethrovaginal fistula by doing urodynamics and micturating cystourethrogram if there is a complain.
15868045|NCT03897491|Drug|5-aminolevulinic acid|5-aminolevulinic acid powder for oral solution
15868046|NCT03897478|Diagnostic Test|ISCDX blood test|"The ISCDX test is based on gene expression changes that occur as a result of the ischemic stroke. When the stroke occurs, the immune system in the body reacts and causes changes in gene expression in several types of cells, including white blood cells, related to activation of innate and adaptive immune systems.
~The ISCDX test distinguishes between cardioembolic and large artery atherosclerotic origin of stroke using a gene signature. The pattern or signature of up or down regulation for all genes for a patient determines whether the patient's pattern of gene expression is more like the pattern seen in other cardioembolic patients or more like the pattern seen in patients with large artery atherosclerotic cause of stroke."
15868047|NCT03897465|Device|Lomatuell Pro|Patients will receive Lomatuell Pro dressings during 3 weeks. Lomatuell Pro® may be left in place up to 7 days; additional dressing changes can be performed as often as necessary according to the instruction for use.
15868048|NCT03897465|Device|UrgoTul|Patients will receive UrgoTul dressings during 3 weeks. UrgoTul® may be left in place up to 7 days; ; additional dressing changes can be performed as often as necessary according to the instruction for use.
15868049|NCT03897452|Drug|Fentanyl (5 microgram/ml) prediluted ampoules|"Bolus; Fentanyl (5 microgram/ml) 0,5 microgram/kg (0.1 ml/kg) is administered over 1 min starting 3-5 min before the lighter skin breaking procedure.
~Fentanyl (5 microgram/ml) 2 microgram/kg is administered over 10 min before the start of the more painful procedur ( pleura drainage or tracheal intubation)."
15868050|NCT03897439|Drug|Nicotine patch|Participants will receive the 24-hour 21mg nicotine patch for up to 18 weeks of treatment.
15868051|NCT03897439|Drug|Varenicline Tartrate|VAR will be dispensed 0.5 mg once daily on Days 1-3, 0.5 mg twice daily on Days 4-7, and 1 mg twice daily from Day 8 through the end of treatment.
15868052|NCT03897439|Drug|Bupropion|BUP will be dispensed 150 mg once daily on Days 0-3 and then 150 mg twice daily from Day 4 through optimization or the end of treatment.
15868053|NCT03897426|Behavioral|Mediterranean Diet - Remote Coaching using a Mobile App|Patients randomized to the intervention arm will be then given an instruction booklet on using Mobile App, directed to a website for additional instruction on its use, and have the app set up to establish connectivity to the RD.
15868054|NCT03897413|Drug|S-888711|Administered orally as three 0.25 mg tablets
15868055|NCT03897413|Dietary Supplement|Calcium Antacid|Calcium carbonate 4000 mg chewable tablets
15868056|NCT03897400|Other|AMH levels in young women with crohn's disease will be considered.|Ovarian Reserve in Young Women of Reproductive Age with Crohn's Disease;Blood will be taken from both the study and control groups and the AMH level will be evaluated.
15868057|NCT03897374|Diagnostic Test|Genetic Testing|Buccal swab
15868058|NCT03897361|Genetic|CTNS-RD-04|Peripheral blood autologous CD34+ enriched cell fraction transduced with lentiviral vector, pCCL-CTNS, that contains the human CTNS complementary deoxyribonucleic acid (cDNA) sequence.
15868458|NCT03894085|Drug|Paroxetine|Paroxetine treatment for 4 weeks usage:20-80mg Qd
15868459|NCT03894072|Device|CPAP|Conventional CPAP
15868061|NCT03897335|Drug|Aminophylline|Aminophylline pre cardiopulmonary bypass and immediately post cardiopulmonary bypass. The dose will be Aminophylline 5 mg/kg/dose, max 350 mg slow infusion. The infusion rate duration will be standardized to 20 minutes. There will be no other aminophylline treatments for the first post-op five days.
15868062|NCT03897335|Drug|Placebos|The placebo group will not receive any aminophylline treatments for the first post-op five days
15868063|NCT03897309|Biological|VXA-G1.1-NN|Monovalent GI.1 tableted vaccine
15868064|NCT03897309|Biological|VXA-G2.4-NS|Monovalent GII.4 tableted vaccine
15868065|NCT03897309|Biological|Placebo Tablets|Tablets matching in number and appearance to active vaccine doses
15868066|NCT03897296|Diagnostic Test|High resolution anorectal manometry, water perfused catheter|High resolution anorectal manometry with the use of water-perfused catheter will be performed to eligible subjects willing to participate in the study
15868067|NCT03897283|Drug|TQB2450|TQB2450 1200 mg administered IV on Day 1 of each 21-day cycle
15868068|NCT03897283|Drug|Anlotinib|Anlotinib capsules given orally in fasting conditions, dose ranging from 8 mg to 12 mg once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21). Initial dose is 10 mg. If there are no patients with DLT in first treatment cycle , begin to explore dose of 12 mg. If there are 2 or more patients in 3 patients with DLT, 8 mg dose is to explore.
15868069|NCT03897270|Procedure|Photoacoustic Imaging|Undergo photoacoustic imaging of the breast
15868075|NCT03897244|Drug|High-dose dual therapy (rabeprazole, amoxicillin)|High-dose dual therapy (rabeprazole 20 mg qid + amoxicillin 750 mg qid, for 14 days)
15868076|NCT03897244|Drug|Bismuth High-dose dual therapy (rabeprazole, amoxicillin, tripotassium dicitrate bismuthate)|Bismuth-High-dose dual therapy (rabeprazole 20 mg qid + amoxicillin 750 mg qid + tripotassium dicitrate bismuthate 300 mg qid, for 14 days)
15868077|NCT03897244|Drug|Amoxicillin-Metronidazole Bismuth quadruple therapy|Amoxicillin-Metronidazole Bismuth quadruple therapy (rabeprazole 20 mg bid + tripotassium dicitrate bismuthate 600 mg bid + amoxicillin 1000 mg bid + metronidazole 500 mg tid, for 14 days)
15868078|NCT03897231|Other|questionnaire|Participants will be invited to participate in the study during their dialysis treatment at the participating hemodialysis outpatient centres. Allocated nurses at Copenhagen University Hospital, Rigshospitalet (MS, AB, LFH, AH), Copenhagen University Hospital, Hillerød (MPL) and Copenhagen University Hospital Herlev (TM) will be responsible for recruitment. Eligible patients will be informed orally and in writing about the study. Participants who wish to participate will be asked to provide informed consent and, following this, complete a paper-based questionnaire during treatment. Patients who have difficulty reading Danish and patients with visual or physical impairments that impinge on their ability to complete the questionnaires will be interviewed using a structured interview approach based on the questionnaires.
15868079|NCT03897218|Dietary Supplement|oatmeal flakes with prebiotic food supplements|The study participants should consume the prescribed amount of the study product every day. The intake should be divided into 1-2 meals. It is not necessary to limit or change normal eating habits.
15868080|NCT03897218|Dietary Supplement|millet flakes|The study participants should consume the prescribed amount of the study product every day. The intake should be divided into 1-2 meals. It is not necessary to limit or change normal eating habits.
15868081|NCT03897205|Drug|Imlifidase|Imlifidase is an IgG degrading enzyme of Streptococcus pyrogenes that cleaves all 4 human subclasses of IgG with strict specificity.
15868082|NCT03897205|Other|Plasma Exchange|The subject's plasma is removed and discarded and the subject receives replacement donor plasma, albumin, or a combination of albumin and saline. IA may be used instead of PE to the discretion of the investigator. IA is achieved by passing a subject's plasma over columns that bind immunoglobulins (Igs) and then the plasma is passed back to the subject.
15868083|NCT03897192|Drug|Bevacizumab|Anti-vascular endothelial growth factor (VEGF)
15868084|NCT03897179|Device|INVSENSOR00032 and INVSENSOR00033|Investigational pulse oximeter device
15868085|NCT03897166|Device|Trimodality|Positron Emission Tomography coupled with Computed tomography and immediately followed by Magnetic Resonance Imaging
15868086|NCT03897153|Device|SONAS® Ultrasound Device|The SONAS® Ultrasound Device is intended for non-invasive transcranial ultrasound and used with a commercially approved contrast agent (e.g., Lumason®/SonoVue®).
15868087|NCT03897140|Diagnostic Test|Diagnostic Test: Limited Echocardiogram|STUDY SOFTWARE non-significant risk (NSR) Bay Labs EchoGPS software interfaced with the Terason uSmart 3200t FDA 510(k)-cleared, commercially available ultrasound EchoGPS software communicates with the ultrasound image formation engine of the 510(k)-cleared Terason uSmart 3200t through an application programming interface (API). EchoGPS will be used to provide visual guidance feedback to users during image acquisition. For this study, RNs will use EchoGPS to perform limited echocardiogram examinations.
15868088|NCT03897127|Drug|Cytarabine|"Induction therapy: 200 mg/m2 i.v. (continuously) d1-7
~Consolidation therapy:
~Patients age 18-60 years
~o Intermediate-dose cytarabine 1500 mg/m2 i.v. q12h (3 hrs) d1-3
~Patients age >60 years o Intermediate-dose cytarabine 1000 mg/m2 i.v. q12h (3 hrs) d1-3"
15868089|NCT03897127|Drug|Daunorubicin|Induction therapy: 60 mg/m2 i.v. (1 hr) d1-3
15868090|NCT03897127|Drug|CPX-351|"Induction 1:
~o CPX-351 44 mg/m2 daunorubicin / 100 mg/m2 cytarabine [100 U/m²] i.v. (90 min) d1,3,5
~Induction 2:
~o CPX-351 44 mg/m2 daunorubicin / 100 mg/m2 cytarabine [100 U/m²] i.v. (90 min) d1,3
~Consolidation therapy:
~o CPX-351 29 mg/m2 daunorubicin / 65 mg/m2 cytarabine [65 U/m²] i.v. (90 min) d1,3"
15868091|NCT03897114|Dietary Supplement|Cocoa group|Athletes perform the same training program and they take 5 g of cocoa (83 mg of flavonoids per gram of cocoa) mixed with low-fat milk for 10 weeks.
15868092|NCT03897114|Dietary Supplement|Placebo group|The athletes perform the same training program and they take for 10 weeks 5 g maltodextrin mixed with low-fat milk for 10 weeks
15868855|NCT03891108|Drug|BMS-986231 Formulation C|Participants will be administered BMS-986231 Formulation C as IV infusion for 48 hours.
15868095|NCT03897075|Drug|Tildrakizumab|PART 1: Double-blind Placebo-controlled PART 2: Double-blind Active Treatment Extension PART 3: Observational Safety Follow-up
15868096|NCT03897075|Drug|Placebo|PART 1: Double-blind Placebo-controlled PART 2: Double-blind Active Treatment Extension PART 3: Observational Safety Follow-up
15868097|NCT03897062|Drug|Suvorexant 20 mg|Placebo controlled double blind suvorexant vs placebo
15868098|NCT03897062|Other|placebo|Placebo controlled double blind suvorexant vs placebo
15868099|NCT03897049|Behavioral|Trans Women Connected|The intervention will address the unique needs of transgender women and the lack of evidence-based, transgender-specific HIV prevention. It is a mobile app delivered sexual health promotion program that engages transgender women through a strengths based approach to HIV prevention and sexual health that uses the power of social networks to identify and encourage protective factors that support the health of transgender women. This approach recognizes the social and structural barriers that transgender women face. In the context of these barriers, which include stigma and discrimination in a number of interconnected spheres, individually-focused behavioral interventions are insufficient. This intervention takes a more comprehensive approach that intentionally targets community strengths and challenges. The mobile app will include more than 30 interactive activities including resource maps, PrEP/PEP content, and communication forums.
15868100|NCT03897049|Behavioral|General Health App|The control group will download a mobile app that addresses general health behaviors and concerns, including sexual health topics.
15868102|NCT03897023|Biological|Gut Microbiota|Status of microbiota
15868103|NCT03897010|Device|Socket Graft|5 patients had bilateral decayed upper premolar or anterior teeth, in one side SCPC graft was inserted in socket and in the contralateral site was a control, 5 months months postoperative core biopsies were taken from both grafted sockets and control ungrafted sockets during implant insertion. The biopsy samples from SCPC-grafted and control ungrafted sockets were fixed, decalcified and embedded into paraffin wax. All samples were serially sectioned in serial 5μm-thin sections were stained separately with Hematoxylin and Eosin staining, Sirius red and Mason trichrome and immunostaining with osteopontin.
15868104|NCT03896984|Drug|Radium-223 (Xofigo, BAY88-8223)|Ra-223 was approved by the FDA in May 2013 for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease.
15868105|NCT03896984|Drug|Abiraterone|Abi is a CYP17 inhibitor. It was approved by the FDA for the treatment of patients with mCRPC in 2011, and for patients with metastatic high-risk castration-sensitive prostate cancer in 2018.
15868106|NCT03896984|Drug|Enzalutamide|Enzalutamide is an androgen receptor inhibitor. It was approved by the FDA for the treatment of patients with mCRPC in 2012, with warning and precautions added in 2017 regarding the risk of seizure and encephalopathy.
15868107|NCT03896971|Drug|Combination of thrombopoietin mimetic and cyclosporin A|This is a controlled interventional study that will be carried out in the Clinical Hematology Unit, at the Department of Internal Medicine , Assiut University Hospital. Patients will be recruited among those who attending the outpatient clinic or admitted in the unit.
15868108|NCT03896945|Drug|Placebo|oral capsules
15868109|NCT03896945|Drug|AVP-786|oral capsules
15868110|NCT03896932|Other|minipooled- Intravenous immunoglobulin(MP-IVIG)|The process of MP-IVIG preparation will involve the use of caprylic acid for purification and virus inactivation of Igs from mini-pools of 20 plasma donations collected in our CBTS in AUH. The equipment used for the process comprised disposable blood bags, hemodialyzers, and purification and microbial filters.
15868111|NCT03896919|Diagnostic Test|HLA-DQ by luminex technology in kidney transplantation|HLA typing (DQ) for donor and recipient using Luminex microbead method from EDTA blood sample
15868112|NCT03896906|Device|High-flow nasal cannula|Apply high ﬂow heated (34 °C) and humidified nasal oxygen with the OptiFlow System (Thrive, Fisher & Paykel®, Aukland New Zealand) using a ﬂow of 30 liter/minute and an inspiratory oxygen fraction (FiO2) of 1.0. Increase the oxygen flow to 60 liter/minute over the course of the first minute. Ask the patients not to speak during anesthesia induction and keep the mouth closed.
15868113|NCT03896906|Device|simple mask|Perform standard preoxygenation by oxygen insufflation via a face mask using the standard anesthesia ventilators (semicircular system) with 100% oxygen ﬂow of 12 liter/minute. The patients breathe with tidal volume.
15868114|NCT03896893|Other|Skin antisepsis|1% aqueous chlorhexidine gluconate
15868115|NCT03896893|Other|Emollient|Aquaphor skin cream
15868116|NCT03896880|Diagnostic Test|blood culture|"During the febrile episode, two blood samples per patient will draw from two separate sites including central venous catheter if present and directly injected to Bact/Alert® bottles and incubated in Bact/ALERT system instrument (bioMérieux Diagnostics, Lyon, France).
~A-Identification of microorganisms including:
~Isolation of microorganisms:
~Blood culture samples with positive signals will be cultured on blood agar, chocolate agar , MacConkeys agar and Sabouraud dextrose agar (SDA) plates.
~B-Identification of the bacterial organism
~Pure colonies of isolated microorganisms were identified by:
~Morphology on agar,Gram stain film was made from the growth to identify morphology of the organism ,Biochemical tests
~C-For fungi isolate the following will perform:
~Microscopic examination of Lactophenol cotton blue (LCB) wet mounts.
~Culture on Brilliance Candida differential agar"
15868117|NCT03896880|Other|Anti fungal susceptibility testing or antibiotic susceptibility testing|isolation of microbes from positive blood culture and anti fungal susceptibility testing or antibiotic susceptibility testing according to isolated microbes by disc diffusion method and Vitek2
15868118|NCT03896880|Other|phenotypic identification methods of the isolated organism by Vitek2 (BioMerieux,France)|The VITEK 2 is an automated microbial identification system that utilizing growth-based technology. With its colorimetric reagent cards, the VITEK 2 offers a state of the art technology platform for phenotypic identification methods.
15868119|NCT03896880|Other|Identification of the isolated organism by multiplex PCR|FilmArray blood culture identification (BCID) is automated multiplex PCR assay, the FilmArray blood culture identification which directly identifies common pathogens, including 7 genera/ species of Gram-positive bacteria, 10 genera/species of Gram-negative bacteria, and 5 species of Candida (as well as 3 resistance determinants) in the positive blood culture bottles. The assay requires about 2 min of hands-on sample processing time and 1 h of instrument time (which includes DNA isolation, amplification, and detection).
15868120|NCT03896867|Device|Anapod™ Humi-Therm Heated Humidification System Breathing Circuit|"For the Anapod™ group, the BairHugger™ blanket will be connected, but the unit will not be turned on. The Anapod™ will be used with a starting circuit temperature set at the standard 45°C (note, this is temperature at the unit - NOT the temperature of the gas reaching the trachea). In the event that the patient's rectal temperature falls below 35.6C, the BairHugger™ warming system will be activated (Hypothermic Rescue). In the event that rectal temperature increases to a value of ≥37.5C, the Anapod system will be turned off - and the BairHugger turned on with the warming unit set to ambient (meaning cool operating room temperature will be blown over the patient (Hyperthermic Rescue)."
15868121|NCT03896867|Device|Bair Hugger™ Warming Blanket|"For the BairHugger™ group, the blanket will be used with a starting temperature set at HIGH. The BairHugger™ unit will be attached to the warming unit and started as soon as possible. In the event that the patient's rectal temperature falls below 35.6C, the Anapod™ warming system will be activated (Rescue). In the event that rectal temperature increases to a value of ≥37.5C, the BairHugger™ warming unit will be set to ambient (meaning cool operating room temperature will be blown over the patient (Hyperthermic Rescue)."
15868122|NCT03896854|Biological|CART-19|CART-19 Split intravenous infusion of CART-19 cells of (Dose escalating infusion of 1 - 20 x10^6 CART-19 cells/kg).
15868123|NCT03896841|Other|Observation|Ocular Findings Observations
15868124|NCT03896828|Dietary Supplement|Mixed-macronutrient meal|"Participants will be provided a mixed-macronutrient meal (liquid drink) at hours 0 and 3, mimicking the energy and macronutrient composition of breakfast and lunch in Western society (38). 20% of daily energy intake will be provided as breakfast and 30% at lunch. Macronutrient composition will reflect a diet providing 55% energy needs from carbohydrate (CHO) and 1.2g/kg/d protein. The remaining energy requirements, as determined by total energy intake, will be met with dietary fat (estimated to be ~0.2 and 0.3g/kg fat for breakfast and lunch, respectively), similar to previous liquid mixed-meal approaches."
15868125|NCT03896815|Drug|INCB054329|
15868126|NCT03896802|Procedure|Physiological assesment|"Arterial and mixed venous blood gas analysis.
~Alveolar and physiologic dead space via volumetric capnometry, as well as carbon dioxide (CO2) production, end-tidal CO2 and mixed expired CO2
~Respiratory system (Crs), chest wall (Ccw) and lung (Cl) compliance measurement via an end-inspiratory and end-expiratory pause.
~Arterial blood pressure, central venous pressure (CVP), heart rate, cardiac output through the arterial pulse contour and transpulmonary thermodilution methods (PiCCO technology). Global end-diastolic volume, Intra-thoracic blood volume, Extravascular lung water will also be assessed. Respiratory hold maneuvers (at PEEP, and +10, +15 and +20 cmH2O) will be performed and CVP and cardiac output will be measured in the last 3 s of the 12 s inspiratory hold. Venous return curve will constructed and the zero-flow pressure recorded as the mean systemic filling pressure.
~Urine flow in 1h and determination of the fractional excretion of sodium and creatinine."
15868127|NCT03896789|Other|PEGASUS Program for Care|This is in essence a checklist of pediatric guidelines to follow for participants who meet inclusion criteria. Site staff will receive training in how to implement this pathway into their usual care.
15868128|NCT03896776|Behavioral|Keep It Up! 3.0|KIU! is an online HIV prevention intervention developed for high-risk young men who have sex with men (YMSM) who recently tested HIV negative. Content was developed in collaboration with YMSM-serving CBOs and subjected to usability testing with diverse YMSM. The Information-Motivation-Behavioral Skills model and eLearning principles guided development of highly interactive, engaging, and culturally relevant health messages. KIU! involves 7 modules completed across 3 sessions, totaling ~1 hour of main content, plus 2 booster sessions at 6- and 12-week follow-ups. Each module is based on a setting or situation relevant to YMSM (e.g., connecting to the gay community and meeting guys through apps), with developmentally appropriate behavior change content embedded. KIU! uses diverse delivery methods (e.g. videos, animation, games) to address HIV knowledge gaps, motivate safer behaviors, teach behavioral skills, and instill self-efficacy for preventive behaviors.
15868129|NCT03896763|Other|Either supine or prone positioning and either CMV or HFOV|"Supine positioning: Subjects randomized to supine positioning will remain supine.
~Prone positioning: Subjects randomized to prone positioning will be positioned prone ≥16 hours/day for a maximum of 28 days.
~CMV strategy: Low tidal volume to obtain exhaled Vt of 5-7 ml/kg (ideal body weight), PIP goal limited to ≤ 28 cm H2O and lung recruitment maneuver to identify best PEEP then maintained per PEEP-FiO2 grid.
~HFOV strategy: Frequency at 8-12 Hz, amplitude (delta-P) 60-90 and mPaw recruitment maneuver."
15868131|NCT03896737|Drug|Daratumumab plus Velcade Cyclophosphamide Dexamethasone|To compare Dara-VCd versus VTd as pre transplant induction and post transplant consolidation, both followed by a maintenance phase with Ixazomib alone or in combination with Daratumumab, in newly diagnosed Multiple Myeloma (MM) young patients eligible for autologous stem cell transplantation.
15868132|NCT03896737|Drug|Velcade Thalidomide Dexamethasone|To compare Dara-VCd versus VTd as pre transplant induction and post transplant consolidation, both followed by a maintenance phase with Ixazomib alone or in combination with Daratumumab, in newly diagnosed Multiple Myeloma (MM) young patients eligible for autologous stem cell transplantation.
15868133|NCT03896724|Biological|R21 adjuvanted with 25mcg Matrix-M|Vaccine
15868134|NCT03896724|Biological|Rabies Vaccine|Vaccine
15868135|NCT03896724|Biological|R21 adjuvanted with 50mcg Matrix-M|vaccine
15868176|NCT03896477|Biological|Synflorix|One single dose contains 1μg of polysaccharide for serotypes 1, 5, 6B, 7F, 9V, 14, and 23F, and 3μg of serotypes 4, 18C, and 19F formulated with aluminum phosphate as an adjuvant.
15868856|NCT03891108|Drug|BMS-986231 Formulation D|Participants will be administered BMS-986231 Formulation D as IV infusion for 48 hours.
15868138|NCT03896698|Device|Transcranial Ultrasound Stimulation|TUS activate the brain cells
15868139|NCT03896685|Drug|Bedaquiline 100 MG|Bedaquiline: 400 mg QD x 2 weeks, followed by 200 mg 3x/week
15868140|NCT03896685|Drug|Delamanid 50 MG Oral Tablet|Delamanid: 100 mg BID
15868141|NCT03896685|Drug|Clofazimine 100 MG Oral Capsule|Clofazimine: 100 mg QD
15868142|NCT03896685|Drug|Linezolid 600Mg Tab|Linezolid: 600 mg QD up to Week 16, followed by 300 mg QD or 600 mg 3x/week according to a secondary randomization
15868143|NCT03896685|Drug|Control arm MDR-TB regimen, designed according to latest WHO guidelines|Control arm MDR-TB regimen, designed according to latest WHO guidelines (might include bedaquiline, delamanid, linezolid, clofazimine, or all of these drugs).
15868144|NCT03896672|Device|Continuous Positive Airway Pressure|Continuous Positive Airway Pressure will be applied three times daily during 7 consecutive days, if the physiotherapist follow the previous training. Each application should during 30 minutes. Pressure should be adjusted in 15 centimeters of water.
15868145|NCT03896659|Drug|Hydrocortisone Oral|Hydrocortisone 160 mg tablet
15868146|NCT03896659|Drug|Placebo Oral Tablet|Hydrocortisone-matched Placebo tablet
15868147|NCT03896646|Procedure|Computed Tomography|Undergo SPECT/CT HIDA scan
15868148|NCT03896646|Other|Hepatobiliary Iminodiacetic Acid Scan|Undergo SPECT/CT HIDA scan
15868149|NCT03896646|Procedure|Single Photon Emission Computed Tomography|Undergo SPECT/CT HIDA scan
15868150|NCT03896646|Radiation|Yttrium Y 90 Glass Microspheres|Undergo radioembolization with yttrium Y 90 glass microspheres
15868151|NCT03896646|Procedure|Yttrium-90 Microsphere Radioembolization|Undergo yttrium-90 microsphere radioembolization
15868152|NCT03896633|Drug|brinzolamide 1% ophthalmic suspension|brinzolamide 1% ophthalmic suspension
15868153|NCT03896633|Drug|Azopt 1%|Azopt 1%, RLD
15868158|NCT03896594|Drug|HL237|Experimental
15868159|NCT03896594|Drug|Placebo Oral Tablet|placebo with same properties except for active ingredient
15868162|NCT03896568|Biological|Oncolytic Adenovirus Ad5-DNX-2401|Given IA
15868163|NCT03896568|Procedure|Therapeutic Conventional Surgery|Undergo surgery
15868164|NCT03896555|Device|ExacTrac position verification|Repeated measurement of patient head position with ExacTrac X-ray Monitoring
15868165|NCT03896542|Device|Commercial video game.|Stroke patient had played with commercial video game, along 12 sessions.
15868166|NCT03896542|Device|rehabilitation video game|Stroke patient had played with an specific video game for rehabilitation, along 12 sessions
15868167|NCT03896529|Behavioral|Anticipatory psychological stress|Unpredictable delivery of low-level electrical stimulation to left ankle periodically throughout psychology tasks (virtual navigation). Established procedure for inducing anticipatory stress.
15868172|NCT03896490|Behavioral|ACT|Infants watch interactive cartoons that respond to infants' direction of gaze. An eye-tracker records the infant's eye movements in real time, relaying this information to the computer. These presentation trigger motivating stimulations (cartoon animations with child-friendly sounds) every time the infant fulfils the demands of a task (e.g. when the infant looks at a character on the screen avoiding to be distracted by other objects moving across the screen). The length of training sessions varies depending on infants' engagement with stimuli and time criteria.
15868173|NCT03896490|Behavioral|Control|The control procedure will involve presentation of cartoons on a screen, while infants' gaze direction will also be recorded using the same eye-tracker and camera. The crucial difference will be that the cartoons in this case are not interactive, thus do not change depending on infants' gaze direction. To ensure presentations in the control procedure are similar in length to those of the intervention group, infants in the control group will be matched infant-by-infant and visit-by-visit with participants in the ACT treatment group: Infants in the control group will see a replay of the session of the matched treated infant. Therefore, while the presentation will be exactly the same (i.e. same length and same stimuli) for the treated and the control child, in the latter case the presentation will not be interactive (i.e. not generated contingently on the infants' visual behaviour).
15868174|NCT03896477|Biological|Pneumosil|One single dose contains 2μg of polysaccharide for serotypes 1, 5, 6A, 7F, 9V, 14, 19A, 19F and 23F, and 4μg for serotype 6B formulated with aluminium phosphate as an adjuvant in an appropriate buffer
15868175|NCT03896477|Biological|Prevenar 13|One single dose contains 2.2 µg of the following pneumococcal polysaccharides serotypes - 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F - and 4.4 µg of pneumococcal polysaccharide serotype 6B, all conjugated to CRM197 and absorbed onto aluminum phosphate
15868177|NCT03896464|Procedure|Soft tissue hamstring autograft|Patients will be prescribed to receive a soft tissue hamstring autograft to for ACL reconstruction.
15868178|NCT03896464|Procedure|Quadriceps tendon autograft|Patients will be prescribed to receive a quadriceps tendon autograft to for ACL reconstruction.
15868179|NCT03896451|Device|Total knee endoprothesis|Total knee endoprosthesis after knee joint osteoarthritis
15868182|NCT03896412|Other|Detecton of circulating tumor DNA|7 blood samples to design a molecular probe
15868183|NCT03896399|Procedure|Laparoscopic ischemic conditioning followed by esophagectomy|All included patients will receive a laparoscopic ischemic conditioning followed by an esophagectomy after an interval of 12-18 days.
15868184|NCT03896386|Other|Use of seizure diary|"The participants will press the alert button when they witness and alerting behaviour on their dogs or the Seizure button when they had experienced a seizure. We will receive this information live through the app back-end"
15868185|NCT03896373|Other|Blood samples|Blood samples
15868186|NCT03896360|Behavioral|Food order behavioral intervention plus standard care|Subjects in the Food order behavioral intervention plus standard care will receive standard counseling by a registered dietitian and additional carbohydrate last food order behavioral counseling by a member of the research team at baseline and Weeks 4, 8 and 12.
15868187|NCT03896360|Behavioral|Standard Care|Subjects will receive standard counseling by a registered dietitian at the baseline visit. Standard counseling will be similarly reinforced at weeks 4, 8 and 12.
15868188|NCT03896347|Other|ViBone®|Viable bone allograft
15868189|NCT03896347|Other|Demineralized Bone Matrix|Demineralized Bone Matrix
15868190|NCT03896347|Other|Bone Morphogenetic Protein|Bone Morphogenetic Protein
15868191|NCT03896334|Behavioral|Supervised Isometric Handgrip Training|The participants randomized to the experimental group will perform 24 weeks of isometric handgrip exercise training, three times/week for 16 minutes with time to rest.
15868192|NCT03896334|Behavioral|Sham comparator - stretching and relaxation exercises|The participants randomized to the control group (active comparator) will perform 24 weeks of stretching and relaxation exercise training, three times/week for 16 minutes with time to rest.
15868193|NCT03896321|Drug|Antiplatelet Agents|effect of dual antiplatelet in management of coronary artery ectasia
15868194|NCT03896321|Drug|Anticoagulants|effect of oral anticoagulants in management of coronary artery ectasia
15868195|NCT03896295|Drug|M281|M281 injection administered as intravenous infusion
15868196|NCT03896282|Other|Mobilization at a dedicated daycare facility|"All THA's are performed using a standard posterolateral approach with simple posterior soft-tissue repair. No infiltration anesthesia (LIA) is used in THA's. All TKA's are performed with a standard medial parapatellar approach without the use of tourniquet. Physiotherapy is started as soon as possible after surgery in the dedicated day care facility. Time till first mobilization is recorded as is total time mobilized supervised by a physiotherapist before discharge.
~Patients are discharged if fulfilling the discharge criteria before 8 pm. Number of hours spent in hospital in total is recorded."
15868197|NCT03896269|Drug|Liposome-encapsulated Daunorubicin-Cytarabine|Given IV
15868198|NCT03896256|Drug|ketamine infusion|Ketamine will be used in subanesthetic doses for patients with refractory chronic migraine to see if it improves pain after a 5-day continuous infusion.
15868199|NCT03896243|Diagnostic Test|Uterine artery ligation (UAL)|"Uterine artery ligation (UAL) We will invite the patients to the hospital at least 6 months after surgery who underwent only uterine artery ligation performed due to uterine atony during C-section.
~They will evaluated for their ovarian reserve via hormones and antral follicle count (AFC)"
15868200|NCT03896230|Drug|Ketamine Injectable Product|Three different doses of ketamine will be administered.
15868201|NCT03896217|Drug|Simvastatin|Simvastatin 40mg for first 4 weeks and 80mg (if tolerated) thereafter up to 17 weeks
15868202|NCT03896204|Behavioral|telephone-suppoted joint protection technique|After joint protection technics training, patients will be followed up with telephone support for 1 month.
15868203|NCT03896204|Behavioral|joint protection technique training|Training will be given to individuals about joint protection technique
15868204|NCT03896191|Procedure|Revision TKR surgery|This study will follow the cohort of patients who have an unstable primary TKR with which they are dissatisfied. They will be assessed before and after their revision TKR surgery.
15868205|NCT03896191|Other|No intervention.|This study will also make a case-control comparison between patients with a stable primary TKR and an unstable primary TKR.
15868206|NCT03896178|Other|None, observational study|None, observational study
15868207|NCT03896165|Other|Reiki|Reiki is a complementary health approach where trained providers place their hands lightly on or just above a person, in discrete positions, with the goal of facilitating the person's own healing response. A Reiki practitioner will perform the initial teaching and instruct the parent how to perform a simple 15-minute Reiki session. Parents will complete a return demonstration using light touch with their adolescent. Parents will be asked to complete a minimum of 15 minutes of Reiki with their adolescent at least five days per week for the four-week intervention period.
15868209|NCT03896139|Drug|Kinase inhibitor|Patients treated with kinase inhibitors for cancer or other conditions
15868210|NCT03896126|Other|Observational|There is no intervention. This is an observational study attempting to establish parameters of normal and abnormal vagal tone in healthy control and gastroparesis patients, as there is currently no metric to determine what dose of vagal stimulation is required to treat gastroparesis.
15868211|NCT03896113|Drug|Celecoxib 200mg capsule|Patient confirmed with endometrial cancer will received twice daily 200 mg Celecoxib, 15 days before the surgery.
15868212|NCT03896087|Diagnostic Test|Abbott RealTime HCV assay from DBS|The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays for detection of HCV RNA. Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.
15868213|NCT03896087|Diagnostic Test|HCV for use on the cobas® 6800/8800 Systems from PSC and DBS|The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays cobas® 6800/8800 Systems for detection of HCV RNA. Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.
15868214|NCT03896087|Diagnostic Test|Aptima® HCV Quant Dx Assay from DBS|The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays Aptima® HCV Quant Dx Assay from DBS for detection of HCV RNA. Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.
15868215|NCT03896087|Diagnostic Test|HCV for use on the cobas® 4800Systems from PSC and DBS|The trial intervention will consist of testing DBS, PSC and plasma samples obtained from trial participants using the centralised molecular assays cobas® 4800 for detection of HCV RNA. Results of testing DBS samples on the HCV assay will not be used to make any clinical decisions, and should not be communicated to study participants.
15868216|NCT03896074|Drug|Atezolizumab|Atezolizumab administered intravenously at 1200 mg every 3 weeks
15868217|NCT03896074|Drug|Bevacizumab|Bevacizumab intravenously at 15 mg/kg every 3 weeks
15868218|NCT03896061|Device|Laparoscopic sleeve procedures|Laparoscopic sleeve procedures with powered stapler
15868219|NCT03896035|Behavioral|Behavioral Intervention Group|The behavioral intervention is designed for older Veterans with cLBP and depression and will include 8 individual telephone sessions delivered by health coaches over a period of 10-20 weeks (up to 5 months total, accounting for additional time between sessions if needed).
15868220|NCT03896022|Device|Acupressure with Beads|Single-use gold-plated 1.2mm beads/balls attach to pre-specified acupoints on the participant's ears with adhesive disk/tape.
15868221|NCT03896022|Device|Acupuncture with Needles|Single-use 1.2mm acupuncture press needles attach to pre-specified acupoints on the participant's ears with adhesive disk/tape.
15868222|NCT03896022|Device|Placebo Adhesive Disks|Single-use adhesive disks without needles or beads.
15868223|NCT03896009|Drug|AXS-07 (MoSEIC meloxicam and rizatriptan)|AXS-07 taken once upon onset of a qualifying migraine.
15868224|NCT03896009|Drug|Meloxicam|Meloxicam taken once upon onset of a qualifying migraine.
15868225|NCT03896009|Drug|Rizatriptan|Rizatriptan taken once upon onset of a qualifying migraine.
15868226|NCT03896009|Drug|Placebo|Placebo taken once upon onset of a qualifying migraine.
15868227|NCT03895996|Drug|AVT001|autologous dendritic cell therapy
15868228|NCT03895996|Other|Placebo|matched placebo
15868229|NCT03895983|Procedure|Percutaneous primary coronary intervention|Percutaneous primary coronary intervention
15868230|NCT03895970|Drug|Lenvatinib plus Pembrolizumab|Lenvatinib 12mg, once a day, oral at least 38 days of each 6 weeks cycle. Pembrolizumab 200mg, every 3 weeks, intravenous infused of each 6 weeks cycle. Number of cycle: until progression or unacceptable toxicity develops.
15868231|NCT03895957|Behavioral|Virtual Reality Exposure Therapy VR Mind+|Virtual Reality Exposure Self-Therapy led by a participant
15868232|NCT03895957|Behavioral|Virtual Reality Exposure Therapy VR Mind|Treatment with Virtual Reality Exposure Therapy led by a therapist
15868233|NCT03895957|Behavioral|Cognitive Behavioral Therapy|Standard treatment for social phobia led by a therapist
15868234|NCT03895944|Biological|ET190L1-ARTEMIS™ T cells -iv low dose|Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET190L1) -ARTEMIS™ expression construct, 1x10^6
15868235|NCT03895944|Biological|ET190L1-ARTEMIS™ T cells -iv middle dose|Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET190L1) -ARTEMIS™ expression construct, 3x10^6
15868236|NCT03895944|Biological|ET190L1-ARTEMIS™ T cells - iv high dose|Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET190L1) -ARTEMIS™ expression construct, 10x10^6
15868237|NCT03895918|Other|Educational Activity|Undergo parenting skills intervention
15868238|NCT03895918|Procedure|Patient Monitoring|Undergo medication adherence monitoring
15868239|NCT03895918|Other|Questionnaire Administration|Ancillary studies
15868240|NCT03895905|Diagnostic Test|colposcopy and colposcopic biopsy|high-risk hpv positivity and colposcopy and cervical biopsy results will be evaluated. thus, it will be defined whether colposcopy will be performed routinely at high-risk hpv.
15868241|NCT03895892|Behavioral|20 km time trial|20 km time trial cycling test will be conducted to measure the effect of different drinks on time
15868242|NCT03895892|Behavioral|Wingate test|30 second all-out effort on a bike will be conducted to measure the effect of different drinks on peak power output
15868243|NCT03895892|Dietary Supplement|Ketone/Caffeine|Dietary supplement containing ketone salts and caffeine
15868244|NCT03895892|Dietary Supplement|Ketone|Dietary supplement containing only ketone salts
15868245|NCT03895892|Dietary Supplement|Water Placebo|Dietary supplement containing only water
15868246|NCT03895879|Drug|Tocilizumab|Tocilizumab sc (162 mg) once every 2 weeks
15868247|NCT03895879|Drug|Tocilizumab|Tocilizumab sc (162 mg) once every week
15868248|NCT03895866|Other|The participants were assigned to different groups according to the results of HPV detection.|The participants were assigned to different groups according to the results of HPV detection
15868249|NCT03895853|Other|Best Practice|Receive standard of care
15868250|NCT03895853|Dietary Supplement|early metabolic resuscitation|Given Intravenous
15868286|NCT03895489|Device|Journey II|Smith and Nephew Richards (SNR) Journey II Knee prosthesis
15868251|NCT03895840|Drug|Zilretta|Zilretta (triamcinolone acetonide extended-release injectable suspension) is indicated as an intra-articular injection for the management of pain due to knee osteoarthritis.
15868252|NCT03895827|Behavioral|Recovery Initiation and Management after Overdose (RIMO)|RIMO uses motivational interviewing and linkage assistance techniques to get people who have had a recent opioid overdose reversal to go to medication-assisted treatment (MAT), stay in MAT, and, if they drop out, go back to MAT treatment.
15868253|NCT03895827|Other|Passive Referral to Treatment Control|Currently neither first responders or emergency department staff regularly refer people to any kind of substance use after an opioid overdose reversal. In the passive referral condition they will at least get a brochure with information on recently expanded and publicly-funded medication-assisted treatment in their community.
15868254|NCT03895814|Behavioral|Protective Step Training|Participants will undergo 6, 1 hour visits (over the course of 2 weeks) where they will be exposed to repeated slips on a treadmill.
15868255|NCT03895801|Drug|IFX-1|intravenously administered
15868256|NCT03895801|Drug|Placebo-IFX-1|intravenously administered
15868257|NCT03895801|Drug|Glucocorticoid (GC)|orally administered
15868258|NCT03895801|Drug|Placebo-Glucocorticoid (Placebo-GC)|orally administered
15868259|NCT03895788|Drug|niraparib|Niraparib will be administered as a flat-fixed dose (100mg or 200 mg, daily) depending on the cohort the patient is enrolled to, and not by body weight or body surface area. Each dose should be swallowed whole without chewing. The consumption of water is permissible. Patients should take doses at approximately the same times each day, and record this information in the patient diary. Patients will be provided with a diary in which to record their intake of study drug. However, the actual number of doses taken by the patient must be calculated from the number of tablets dispensed and returned.
15868260|NCT03895788|Drug|Brivanib|Brivanib will be administered as a flat-fixed dose (200mg, 400 mg, or 600 mg daily) depending on the cohort the patient is enrolled to, and not by body weight or body surface area.
15868261|NCT03895749|Dietary Supplement|NEO40 Daily|Per Capsule: N5-carbamoylornithine 100 mg, crataegus laevigata 100 mg, L-ascorbic acid 50 mg, vitamin B-12 0.05 mg, vitamin C 50 mg.
15868262|NCT03895736|Biological|blood sampling|Sampling of 15 ml of blood during a blood test at Day 0, Day 1 and Day 3
15868263|NCT03895723|Procedure|laparoscopic and robotic liver resection|laparoscopic and robotic procedure for liver resection
15868264|NCT03895723|Procedure|open surgery|using open surgery procedure for liver resection
15868265|NCT03895697|Drug|dasiglucagon|Glucagon analogue
15868267|NCT03895671|Drug|Ponatinib|"Induction phase (first three cycles)
~- ponatinib: 45 mg/day orally continuously
~Following the results of disease evaluation after 3 cycles:
~Cohort A: AP-CML If a CHR and complete cytogenetic response are obtained after 3 months, ponatinib will be decreased at 30mg/day. If CHR and/or CCyR are not reached, ponatinib may be maintained at 45mg/day for another 3 cycles if decided by the investigator.
~Cohort B: MBC-CML If a CHR is obtained during the induction phase, ponatinib daily dose will be reduced to 30 mg/day. If CHR is not reached, ponatinib may be maintained at 45mg/day for another 3 cycles if decided by the investigator.
~Maintenance therapy:
~Ponatinib will be decreased to 30 mg/day. During maintenance therapy, If a major molecular response is reached, ponatinib will be decreased to 15mg/day"
15868268|NCT03895671|Drug|Azacitidine|"Induction phase (first three cycles), Following the results of disease evaluation after 3 cycles and Maintenance therapy:
~- 5-azacitidine : 75 mg/m² subcutaneously day 1 to day 7, every 4 weeks
~No dose modification of 5-Azacitidine is planned in both cohorts. Azacitidine may be stopped at 24 months in case of MR4 defined as 0.0032%<MR4≤0.01%;"
15868272|NCT03895619|Other|Safer conception strategies|Individuals and couples adopt safer conception strategies including HIV-serostatus disclosure to partner, ART uptake and adherence and HIV-RNA suppression, STI testing and treatment, timing condomless sex to peak fertility, partner ARV use (ART if living with HIV, PrEP if HIV negative), and contraception until ready to conceive.
15868273|NCT03895606|Other|Data collection|This study is an observational study collecting perioperative data. There is no intervention regarding this study.
15868274|NCT03895593|Other|rescue fecal microbiota transplantation|Fecal microbiota transplantation refers to the infusion of fecal microbiota from healthy donor into patients' gastrointestinal tract.
15868275|NCT03895580|Other|In-store POP education|Six in-store nutrition counseling sessions with a registered dietitian nutritionist.
15868276|NCT03895580|Other|Online POP education|Education on the use of an online grocery shopping, an online recipe tool, a grocery pickup service, a home grocery delivery service, and a phone application that promotes healthy food selection.
15868277|NCT03895567|Drug|A. Ceftriaxone (Roche ®) 500mg (slow intravenous injection)|"Parenteral ceftriaxone
~Intravenous injection of 500mg of ceftriaxone sodium (Rocephin®; Roche)."
15868278|NCT03895567|Drug|B. Ceftriaxone rectal dosage form test formulation 1 (1 x 500mg)|"Rectal ceftriaxone formulations
~Formulation 1 ceftriaxone 500mg + Na-CDC 125mg + dicalcium phosphate (binder)"
15868279|NCT03895567|Drug|C. Ceftriaxone rectal dosage form test formulation 2 (1 x 500mg)|"Rectal ceftriaxone formulations
~Formulation 2 ceftriaxone 500mg + Na-CDC 125mg + mannitol (binder)"
15868280|NCT03895554|Procedure|cardiac PET stress test|Volunteers will undergo cardiac PET stress testing
15868281|NCT03895541|Diagnostic Test|SuperSonic image|3 examen performed assessed to compared evaluation type: Cardiac magnetic resonance imaging, standard ultrasound imaging and ultrafast imaging
15868282|NCT03895528|Drug|Lonafarnib|Farnesyl transferase inhibitor
15868283|NCT03895515|Drug|Fiasp®|Participants receive treatment with Fiasp® according to routine clinical practice. All treatment decisions, including assignment of participants to Fiasp® treatment, were made independently of the study and prior to the participants' inclusion in the study.
15868284|NCT03895502|Drug|12-month Edoxaban|Prescription of Edoxaban for 12 months
15868285|NCT03895502|Drug|3-month Edoxaban|Prescription of Edoxaban for 3 months
15868287|NCT03895489|Device|Stryker|Stryker Triathlon Total Knee prosthesis
15868289|NCT03895476|Diagnostic Test|palatal wound will not cover|after harvesting the graft from the palate the wound will be left uncovered with secondary healing intention
15868290|NCT03895476|Diagnostic Test|palatal wound covered with platelet rich fibrin|after harvesting the graft from the palate the platelet rich fibrin will be sutured to covered the harvested site
15868291|NCT03895476|Diagnostic Test|palatal wound covered with a collagen sponge and cyanoacrylate|after harvesting the graft from the palate a collagen sponge will be sealed with cyanoacrylate in position
15868292|NCT03895476|Diagnostic Test|palatal wound covered with a stent|after harvesting the graft from the palate a stent that will be prepared for the patient, will be placed on to cover the wound
15868293|NCT03895450|Behavioral|Aerobic Exercise Protocol|Participants randomized to AEP will be asked to exercise 30 minutes per day or until symptom exacerbation, 5-6 days per week either at home, outdoors or at a fitness facility of choice. The assigned exercise prescription target will be 70-80% of the maximum HR achieved during the treadmill test. HR monitors will be provided to monitor exercise intensity.
15868294|NCT03895450|Behavioral|Stretching Protocol|Participants will follow a stretching protocol for 30 minutes a day, 6 days a week. Individuals in the SP group will be given a booklet explaining a low-impact breathing and stretching program developed at the University of Buffalo. All stretches will explained and demonstrated by a member of the study team prior to commencement of the program. Stretches focus on lower extremity muscles. During the protocol HR should be low as to not exceed 50% of age predicted max. A HR monitor will be worn during stretching.
15868295|NCT03895437|Biological|TOL-3021|TOL-3021 1 mg is a bacterial plasmid expression vector containing the coding sequences for the human proinsulin (hINS) gene.
15868296|NCT03895437|Other|TOL-3021 Placebo|TOL-3021 Placebo
15868297|NCT03895424|Dietary Supplement|IFAC|This intervention will contain the iron fatty acid complex in a capsule. The complex will be labelled with the iron isotope 58Fe
15868298|NCT03895424|Dietary Supplement|MIFAC|This intervention will contain the micellarized form of the iron fatty acid complex in a capsule. The complex will be labelled with the iron isotope with 57Fe
15868299|NCT03895424|Dietary Supplement|Control Ferrous Sulfate|This intervention will contain ferrous sulfate in the form of a solution labelled with the iron isotope 54Fe. A capsule with the same amount of fat as in the other arms will be administered to the participants
15868300|NCT03895411|Drug|sotalol|Oral sotalol 2.5mg/kg/time, per 12h
15868301|NCT03895411|Drug|Propafenone|Oral Propafenone 5mg/kg/time, pre 8h
15868302|NCT03895411|Drug|betaloc|Oral betaloc 0.5mg/kg/time ,pre 12h
15868303|NCT03895398|Other|nutrition and psychosocial intervention with community participatory|community participation to ensure the intervention is given to the study subject (underfive children)
15868304|NCT03895385|Drug|Bimekizumab|Subjects will receive a single dose bimekizumab at a predefined time point during the Treatment Period.
15868305|NCT03895372|Drug|PF-06826647 or Placebo|Delivered orally (tablet) once daily (QD) for 16 weeks during the Investigational Treatment Period
15868306|NCT03895372|Drug|PF-06826647|Delivered orally (tablet) once daily (QD) for 24 weeks during the Extension Period
15868307|NCT03895359|Radiation|Stereotactic Body Radiation|For patients randomized to the SMRT arm, SBRT is to be delivered over 5 fractions delivered over 5 to 15 days.
15868308|NCT03895359|Drug|Transarterial Chemoembolization|Transarterial chemoembolization is a standard treatment for patients with hepatocellular carcinoma (liver cancer). Chemotherapy is injected into the arteries of the liver and liver cancer.
15868309|NCT03895346|Behavioral|Mindfulness|Mindfulness meditation is a technique of sustained attention and focus, involving preventing the mind from wandering from the meditative object (i.e. breath or body sensations)
15868310|NCT03895346|Behavioral|Brain Games and Puzzles|Intervention will include the instruction and practice of puzzles such as word searches, crossword puzzles, Sudoku, and KenKen.
15868311|NCT03895333|Other|Audiological profiling and bone mineral densitometry measurement|bone mineral densitometry measurements and hearing test patients, osteoporosis according to whether the hearing test will be analyzed.
15868312|NCT03895320|Behavioral|Sexual Health Risk Assessment|The self-assessment ('Sexual Health Risk Assessment'), will pertain to sexual and reproductive health. The self-assessment, will include a valid clinical prediction tool, established to predict STI positivity.
15868313|NCT03895320|Behavioral|Sexual Health Score|The results of the 'Sexual Health Risk Assessment' will produce a score ('Sexual Health Score'). The 'Sexual Health Score' will be presented as a number (0/10) and will be organized by category: Low, Medium or High Risk.
15868314|NCT03895320|Behavioral|Sexual Health Messaging|After the score ('Sexual Health Score') the participant will receive personalized messaging ('Sexual Health Messaging') that relates to their score and risk level (i.e. Low, Medium or High). Short messages that indicate key steps the person can take to lower their risk for STIs will be displayed on the screen that correspond to their 'Sexual Health Score.'
15868315|NCT03895320|Behavioral|Water SSB Quiz|The self-assessment ('Water SSB Quiz') will pertain to consumption of water, soda and sugar sweetened beverages. There will not be a comparable clinical prediction tool in the control self-assessment ('Water SSB Quiz).
15868316|NCT03895320|Behavioral|Water SSB Score|The results of the 'Water SSB Quiz' will produce a score ('Water SSB Score'). The 'Water SSB Score' will be presented as a number (0/10).
15868317|NCT03895320|Behavioral|Water SSB Messaging|After the score ('Water SSB Score') the participant will receive personalized messaging ('Water SSB Messaging') that relates to their score. Short messages that indicate key steps the person can take to meet the recommended daily intake for water and sugar sweetened beverages will be displayed on the screen that correspond to their 'Water SSB Score.'
15868318|NCT03895320|Behavioral|STI Screening|All participants regardless of group, will be offered a STI screening kit immediately after receipt of their respective program (intervention or control). Participants will have the option of completing the kit at the first study visit, taking it with them after the first study visit is over, or receiving it later from one of our staff either at our local project office or the kit can be dropped off at a location the participant chooses. Completed kits can be returned to our office or picked up by a study staff. (NOTE: while the STI screening kit will be available to all participants should they request it at subsequent study visits, e.g. the 3- and 6-month follow-ups, the STI screening kit will only be explicitly offered by the study team at the first study visit immediately after participants complete their respective quiz).
15868322|NCT03895294|Other|Health care under the strategic purchase-Clinical pathway|1) purchase of DAA by the MoHSP; 2) diagnosis of the patient (confirmed by quantitative HCV RNA test); 2) prescription of the treatment by a specialist in internal medicine, hepatology or Infectious disease; 3) daily supervised drug administration by a nurse or weekly treatment dispensing by pharmacist; 4) Pharmaceutical Care (includes: consultation with pharmacist at weeks 0, 4, week of the end of treatment (8, 12 or 24) and week of evaluation of effectiveness (week 12 or 24 after the end of treatment); health education and administrative support. In case of identifying any Drug-related Problem, the respective pharmaceutical intervention was made.
15868323|NCT03895294|Other|Usual care process prior strategic purchase-clinical pathway|1) diagnosis of the patient (confirmed by quantitative HCV RNA test); 2) prescription of the treatment by a specialist in hepatology; 3) weekly treatment dispensing by pharmacist; 4) patient use; 5) Pharmaceutical Care (includes: consultation with pharmacist at weeks 0, 4, 8, week of the end of treatment (12 or 24) and week of evaluation of effectiveness (week 12 or 24 after the end of treatment); health education and administrative support). In case of identifying any Drug-related problem, the respective pharmaceutical intervention was made.
15868324|NCT03895281|Diagnostic Test|FilmArray Meningitis/Encephalitis (ME) Panel|The FilmArray ME pouch is a closed system disposable that houses all the chemistry required to isolate, amplify and detect nucleic acid from multiple meningitis and encephalitis pathogens within a single CSF specimen obtained from a lumbar puncture. The rigid plastic component (fitment) of the FilmArray ME pouch contains reagents in freeze-dried form. The flexible plastic portion of the pouch is divided into discrete segments (blisters) where the required chemical processes are carried out. The user of the FilmArray ME Panel loads the sample into the FilmArray ME pouch, places the pouch into the FilmArray instrument/Module, and starts the run. All other operations are automated.
15868325|NCT03895268|Device|ALiA Analyser|NPS specimens shall be tested with the investigational device
15868326|NCT03895268|Device|Influenza A+B Test Kit|NPS specimens shall be tested with the investigational device
15868327|NCT03895255|Procedure|Paraaortic lymph node dissection, IMA high ligation, TME, routine splenic flexure mobilization|Nerve-sparing paraaortic lymph node dissection is performed. The inferior mesenteric artery is divided at 1-2 cm from its origin from the aorta. Nerve-sparing total mesorectal excision is performed. Splenic flexure is mobilized. Side-to-end sigmoido-rectal anastomosis is created.
15868328|NCT03895255|Procedure|Paraaortic lymph node dissection, IMA low ligation, TME, selective splenic flexure mobilization|Nerve-sparing paraaortic lymph node dissection is performed. Then inferior mesenteric artery is skeletonized down to the origin of left colic artery and divided below it. Nerve-sparing total mesorectal excision is performed. Splenic flexure is mobilized only if sigmoid colon is unsuitable for anastomosis or doesn't reach the rectal stump. Then descending-rectal side-to-end anastomosis is created.
15868329|NCT03895242|Behavioral|Group 1:Supine-Prone|After the infants were treated and fed, supine position was first given and waited for 60 minutes to stabilise (no data was collected during this time). After 61 minutes, it was allowed to stay in supine position for 2 hours. From the 61st minute, heart rate and oxygen saturation were evaluated in each infant in the supine positions at intervals of 15 min over a period of 120 min. At the end of two hours, the infant was given the prone position after the routine requirements such as diaper replacement were completed. Infants were waiting for 60 minutes to stabilize after the prone position (no data was collected during this time). From the 61st minute, heart rate and oxygen saturation were evaluated in each infant in the prone positions at intervals of 15 min over a period of 120 min.
15868330|NCT03895242|Behavioral|Group 2:Prone-Supine|After the infants were treated and fed, prone position was first given and waited for 60 minutes to stabilise (no data was collected during this time). After 61 minutes, it was allowed to stay in prone position for 2 hours. From the 61st minute, heart rate and oxygen saturation were evaluated in each infant in the prone positions at intervals of 15 min over a period of 120 min. At the end of two hours, the infant was given the supine position after the routine requirements such as diaper replacement were completed. Infants were waiting for 60 minutes to stabilize after the supine position (no data was collected during this time). From the 61st minute, heart rate and oxygen saturation were evaluated in each infant in the prone positions at intervals of 15 min over a period of 120 min.
15868331|NCT03895229|Drug|Empagliflozin 10 MG Oral Tablet [Jardiance]|Empagliflozin is a sodium-glucose co-transporter 2 inhibitor approved for treatment of type 2 diabetes mellitus
15868335|NCT03895190|Behavioral|Flourishing App Program|This intervention is based on relaxation, well-being promotion, meditation practices and positive psychology principles. The program is being evaluated in a classroom format into another project and was adapted for this project in the application format for mobile devices. It will last for 8 weeks, with trainings of 15 to 25 minutes, four times a week.
15868336|NCT03895177|Diagnostic Test|contrast enhanced computed tomography|pancreatic protocol CT with 80kVp tube voltage and more than 500mA tube current acquire late arterial phase and portal venous phase using volus tracking method
15868337|NCT03895164|Behavioral|Enhanced NE|Standard nutrition education package from primary health care enhanced with local specific food-based complementary feeding recommendation
15868338|NCT03895164|Behavioral|Standard NE|Standard nutrition education package from primary health care
15868339|NCT03895151|Dietary Supplement|Milk supplementation|Fresh milk from local farmer. No artificial sweetener and preservatives. Brandless.
15868340|NCT03895151|Other|Food Based Recommendation (FBR) nutrition education|Food Based Recommendation is result of OPTIFOOD WHO that analysed local food to optimize nutritional status according to problem nutrient.
15868341|NCT03895138|Other|Standard Glucommander Protocol (SGP)|Subjects receive standard Glucommander-based insulin therapy from the clinical staff of U.Va.'s cardiothoracic ICU and follow manufacturer's guidelines for starting with an initial multiplier value of .05.
15868373|NCT03894865|Other|procedure1|The students will be asked to bend forward with his knees straight, feet together and hands freely and loosely hanged. if there was scoliosis the rib cage rotated and a hump appeared. Positive test indicated the presence of a rib hump and negative if there was any hump appeared
15868374|NCT03894865|Other|procedure2|Measurement of the angle of trunk rotation (ATR) by using a scoliometer HD smartphone application.
15868342|NCT03895138|Other|Optimized Glucommander (OGM)|The experimental arm of the study involves treating subjects with a lower initial multiplier (.02 versus .05), a higher set of BG thresholds (140-180 mg/dl vs 120-160) in the first eight (8) hours of care for avoidance of hypoglycemia in that time period, and a requirement for consistent hourly-or-faster sampling of BG (as opposed to the Glucommander recommendation which is dependent on the trajectory of BG and can sometimes allow intervals of two hours between samples). After the eight (8) hours, the Glucommander is set back to the standard protocol for the entire duration of the subject's post-operative hospital stay.
15868343|NCT03895125|Behavioral|[year1] dual-task training with task priority strategy|postural focus: focus mainly on postural performances while dual-tasking suprapostural focus: focus mainly on suprapostural performances while dual-tasking
15868344|NCT03895125|Behavioral|[year2-3] dual-task training with internal and external focus|internal focus: focus mainly on body movements external focus: focus mainly on object in the environment
15868345|NCT03895112|Drug|AVID200|dose cohorts of 21-day cycles
15868346|NCT03895099|Drug|Desogestrel early follicular phase|Start of ovarian stimulation in early follicular phase
15868347|NCT03895099|Drug|Desogestrel medium follicular phase|Start of ovarian stimulation in medium follicular phase
15868348|NCT03895099|Drug|Desogestrel ovulatory phase|Start of ovarian stimulation in ate follicular phase
15868349|NCT03895099|Drug|Desogestrel late follicular phase|Start of ovarian stimulation in ovulatory Phase
15868350|NCT03895099|Drug|Desogestrel luteal phase|Start of ovarian stimulation in luteal phase
15868351|NCT03895086|Other|Specific Physical Activity|An individual one hour face-to-face session conducted by adaptated physical activities teachers followed by eight telephone sessions by physical therapists and adaptated physical activities teachers (4 sessions each)
15868352|NCT03895086|Behavioral|Classic Physical Activity|"One session per week in groups conducted by adaptated physical activities teachers of Siel Bleu association"
15868353|NCT03895073|Other|healthy volunteers|the questionnaire has been assessed by both groups, healthy and heart failure
15868354|NCT03895060|Device|autogenous ring blockls with GBR covered by collagen membrane|"A crestal incision is made using No. 15 blade extending over the anterior maxilla, an anterior vertical releasing incision is made and a full mucoperiosteum flaps elevated to provide access to the alveolar ridge and the lateral aspect of the maxilla
~Autogenous onlay ring blocks is taken by a trephine bur from the chin area and then fixed by screws to the deficient maxillary alveolar height.
~Equally autogenous and xenograft bone particles is packed around the screw to fill the defect area completely.
~The collagen membrane is fixed to the alveolar ridge by bone tacks and the mixture of autogenous and xenograft bone is then packed.
~The flap will then be closed using interrupted 4/0 resorbable sutures."
15868355|NCT03895047|Other|tomographic EEG Neurofeedback Training|EEG-Electrodes are placed on the patients head to record the brain activity, EEG-recordings are processed by the standardized Low Resolution Brain Electromagnetic Tomography algorithm (sLORETA) to calculate the frequency spectrum in the auditory cortex, the insula and the anterior cingulate cortex and deliver feedback for the patient
15868356|NCT03895034|Device|Light Adjustable lens (LAL) and Light Delivery Device (LDD)|Eligible eyes will receive Light adjustable lens with Light delivery Device treatments
15868357|NCT03895021|Behavioral|Pisando Fuerte|"Pisando Fuerte, a linguistically and culturally appropriate version for Spanish speakers of an evidence-based fall prevention program (Stepping On [SO])."
15868358|NCT03895008|Other|Cardia and Non-cardia gastric cancer|We classify gastric cancer into cardia gastric cancer and non-cardia gastric cancer.
15868359|NCT03894995|Other|Installation of ventilation|The intervention is installation of a ventilating structure, in this case a window in the house roof.
15868360|NCT03894982|Other|Group Classes|Family Learning on Asthma Topics classes will aim to emphasize, encourage, and support teaching methods that include standardized instructions. There will be three topics lasting approximately 45 minutes: General Asthma Knowledge; Asthma Triggers, Medications, and Self-Management. These topics were chosen based on the EPR-3 guideline recommendations to ensure the continuity of messaging. Each class size will be approximately 8 persons and will be taught by a Certified Asthma Educator (AE-C) and will be held in the Family Learning Center at the Children's Hospital Colorado. Classes will be taught in both English and Spanish.
15868361|NCT03894969|Biological|GSK's investigational non-typeable Haemophilus influenzae (NTHi) and Moraxella catarrhalis (Mcat) multi-antigen vaccine (GSK3277511A) adjuvanted with AS01E|2 doses of the investigational NTHi-Mcat vaccine will be administered 2 months apart to all subjects in all the groups. The vaccine will be given intramuscularly (IM) in the upper deltoid of non-dominant arm
15868362|NCT03894969|Biological|Shingrix GSK's lyophilized formulation of the herpes zoster (HZ) vaccine (GSK1437173A)|2 doses of the Shingrix vaccine will be administered at days 1 and 61 to all subjects in groups Sh_NTHi-Mcat_1, 3 and 6. The vaccine will be given intramuscularly (IM) in the upper deltoid of the non-dominant arm
15868363|NCT03894943|Diagnostic Test|PET/CT scan|Patient receive a PET/CT scan of their cerebrum and lumbar spine prior to surgery, 4-6 weeks after surgery and 6 months after surgery
15868364|NCT03894943|Diagnostic Test|Quantitative Sensory Testing|Patients undergo a battery of quantitative sensory tests prior to surgery, 4-6 weeks after surgery and 6 months after surgery
15868365|NCT03894930|Behavioral|Metta meditation|Administered 5 days per week for 8 weeks.
15868366|NCT03894917|Other|Comprehensive Geriatric Assessment (CGA)|Assessments will be done for participants that are 65 years or older.
15868367|NCT03894904|Drug|Papaverine|"1mL volume bolus will be given from the research syringe as soon as the arterial catheter is placed. Another subsequent 1mL bolus will be given one hour after the initial bolus if needed."
15868368|NCT03894904|Drug|Heparin|"1mL volume bolus will be given from the research syringe as soon as the arterial catheter is placed. Another subsequent 1mL bolus will be given one hour after the initial bolus if needed."
15868369|NCT03894891|Drug|Nivolumab|Nivolumab is a type of immunotherapy that tries to enhance participants own immune system to fight cancer
15868370|NCT03894891|Drug|Cisplatin|Cisplatin is a chemotherapy medication used to treat a number of cancers
15868371|NCT03894891|Drug|Docetaxel|Docetaxel (Taxotere®) is a chemotherapy drug. It is used to treat many types of cancer including head and neck
15868372|NCT03894891|Radiation|Radioimmunotherapy|Radiation Therapy to shrink or kill tumors.
15868857|NCT03891095|Drug|Oxytocin|intranasally administrated
15868376|NCT03894839|Other|glutaraldehyde disinfection and microwave application|Combination of the chemical disinfection which could be done by patients and professional disinfection methods which is done by dentists
15868377|NCT03894839|Other|Chlorhexidine gluconate disinfection and microwave application|Combination of the chemical disinfection which could be done by patients and professional disinfection methods which is done by dentists
15868378|NCT03894839|Other|Sodium hypochlorite disinfection and microwave application|Combination of the chemical disinfection which could be done by patients and professional disinfection methods which is done by dentists
15868379|NCT03894839|Other|glutaraldehyde disinfection and ozone therapy|Combination of the chemical disinfection which could be done by patients and professional disinfection methods which is done by dentists
15868380|NCT03894839|Other|Chlorhexidine gluconate disinfection and ozone therapy|Combination of the chemical disinfection which could be done by patients and professional disinfection methods which is done by dentists
15868381|NCT03894839|Other|Sodium hypochlorite disinfection and ozone therapy|Combination of the chemical disinfection which could be done by patients and professional disinfection methods which is done by dentists
15868382|NCT03894826|Drug|Vorinostat 100 MG|Vorinostat administered by mouth, once daily at a dose of 230 mg/m2/day for a total of 6 weeks
15868383|NCT03894813|Drug|"Probiotics and Metronidazole"|Oral probiotics (Umeta-Miyue, Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14) (qd, 30 days)+Metronidazole Suppositories (qd, 7 days)
15868384|NCT03894813|Drug|Metronidazole Vaginal|Metronidazole Suppositories,qd, 7 days
15868385|NCT03894800|Drug|Methoxyflurane (M)|The subjects will undergo CPT (cold pressor test) to determine the analgesic effect of the drugs, in this intervention inhalation of metoxyflurane 3 ml and NaCl i.v. will be administered.(13,14) The CPT will be conducted using a temperature-controlled bath with circulating 3°C water (FP 45-HE Refrigerated/Heating Circulator, Julabo Labortechnic, 77960 Seelback, Germany). The subjects submerge their right hand to the wrist with fingers abducted for up to 90 s. The endpoints are NRS scores every 10 s.This test will be performed 3 times for each session.
15868386|NCT03894800|Drug|Fentanyl (F1)|The subjects will undergo CPT (cold pressor test) to determine the analgesic effect of the drugs, in this intervention fentanyl 0.025 mg i.v. and NaCl for inhalation will be administered(13,14) The CPT will be conducted using a temperature-controlled bath with circulating 3°C water (FP 45-HE Refrigerated/Heating Circulator, Julabo Labortechnic, 77960 Seelback, Germany). The subjects submerge their right hand to the wrist with fingers abducted for up to 90 s. The endpoints are NRS scores every 10 s.This test will be performed 3 times for each session.
15868387|NCT03894800|Drug|Fentanyl (F2)|The subjects will undergo CPT (cold pressor test) to determine the analgesic effect of the drugs, in this intervention fentanyl 0.05 mg i.v. and NaCl for inhalation will be administered.(13,14) The CPT will be conducted using a temperature-controlled bath with circulating 3°C water (FP 45-HE Refrigerated/Heating Circulator, Julabo Labortechnic, 77960 Seelback, Germany). The subjects submerge their right hand to the wrist with fingers abducted for up to 90 s. The endpoints are NRS scores every 10 s.This test will be performed 3 times for each session.
15868388|NCT03894800|Drug|NaCl (C)|The subjects will undergo CPT (cold pressor test) to determine the analgesic effect of the drugs, in this intervention NaCl i.v. and NaCl inhal will be used - placebo(13,14) The CPT will be conducted using a temperature-controlled bath with circulating 3°C water (FP 45-HE Refrigerated/Heating Circulator, Julabo Labortechnic, 77960 Seelback, Germany). The subjects submerge their right hand to the wrist with fingers abducted for up to 90 s. The endpoints are NRS scores every 10 s.This test will be performed 3 times for each session.
15868389|NCT03894774|Behavioral|Intensive in-patient psychotherapy treatment|Intensive non-pharmaceutical in-patient intervention with high degrees of individual psychotherapy (5 sessions a week, psychodynamic and specific trauma therapy), group therapy (music-, arts-, sports- and concentrative movement therapy - each one session a week) as well as an ongoing milieutherapeutic setting where patients live during the whole treatment (approximately a 1:1-Ratio caregiver per patient is given) of 6 to 8 month treatment duration.
15868390|NCT03894774|Other|Treatment as usual|Combination of behavioral or psychoanalytic outpatient psychotherapy and pharmacotherapy
15868391|NCT03894761|Other|Night Pain in Patients with Rotator Cuff Syndrome|The pain severity was evaluated using a 10 cm visual analogue scale , where 0 represented no pain, while 10 represented unbearable pain.At evaluation, the average of the pain during night for the last one week were inquired.
15868392|NCT03894748|Drug|Botulinum Toxin Type A|20U of the investigational drug will be intramuscularly injected to 5 sites of the glabella line. Treatment will be conducted just once in visit 2.
15868393|NCT03894722|Procedure|Control|During the third molar extraction the saline solution will be used in the control group.
15868394|NCT03894722|Procedure|0.5% concentration of PVP-I|During the third molar extraction 0.5% concentration of PVP-I solution will be used in the test group.
15868395|NCT03894722|Procedure|1 % concentration of PVP-I|During the third molar extraction 1 % concentration of PVP-I solution will be used in the test group.
15868396|NCT03894722|Procedure|3 % concentration of PVP-I|During the third molar extraction 3 % concentration of PVP-I solution will be used in the test group.
15868397|NCT03894709|Behavioral|family-centered care model|Teaching and training family caregivers to enhancing their skills for providing care for hip-fractured older persons The content of teaching material provided including management of wound, nutritional and balanced diet, rehabilitation exercises, home environment and behavioral problems after a hip surgery
15868398|NCT03894696|Drug|Direct Acting Antivirals|follow up chronic HCV patients recieving DAAs to detect anxiety and depression
15868399|NCT03894683|Drug|Melatonin 10 mg|Melatonin tablets (10 mg)
15868400|NCT03894683|Drug|Placebo Oral Tablet|Placebo tablets manufactured the same as melatonin tablets
15868401|NCT03894670|Other|Standard mixed breakfast meal|"The standard mixed breakfast meal consists of:
~150 g yoghurt, 20 g muesli; 50 g wheat bun; 22 g rye bread; 25 g cheese; 25 g marmalade; 8 g butter; Total energy content: 500 kcal Macronutrient composition: 34 E% fat, 17 E% protein, 49 E% carbohydrate"
15868402|NCT03894670|Other|SmartBar™|SmarBar™ (Medtronic, North Haven, MA, USA). Weight: 72 g; Total energy content: 260 kcal Macronutrient composition: 7 E% fat, 19 E% protein, 74 E% carbohydrate.
15868403|NCT03894657|Diagnostic Test|Nasal brushing|Nasal scrapping at visit V0
15868460|NCT03894072|Device|HFHO|A device that can provide heated humidified oxygen up to 30-60 liter per minute, FiO2 (fraction of inspired oxygen) 0.21-0.95
15868404|NCT03894657|Other|Sputum sample|"Visit V0 : 1 Aliquot for Sputum biobank
~Visit V1 : 2 Aliquots
~for Sputum biobank
~for pharmacokinetic (PK) study
~Visit V2 : 2 Aliquots
~for Sputum biobank
~for pharmacokinetic (PK) study"
15868405|NCT03894657|Other|blood sample|"Visit V0 : Additional 14 mL
~5 mL in ethylenediaminetetraacetic acid (EDTA) tube for DNA Analysis
~3 mL in Dry tube for Serum biobank
~6 mL in acid citrate dextrose (ACD) tube for peripheral blood mononuclear cell (PBMC) biobank
~Visit V1 : Additional 9 mL
~2x3 mL in dry tube for pharmacokinetic (PK) study
~3 mL in Dry tube for Serum biobank
~Visit V2 : Additional 6 mL
~3 mL in dry tube for pharmacokinetic (PK) study
~3 mL in Dry tube for Serum biobank"
15868406|NCT03894657|Drug|Orkambi|"Study the predictive value for improvement of the respiratory function after 24 weeks of Orkambi treatment.
~Orkambi treatment is part of usual care."
15868407|NCT03894644|Other|Simulation technology|The intervention involves three consecutive sessions of the PeriopSim™ Instrument Trainer, followed by two consecutive sessions of the PeriopSim™ for Burr Hole Surgery (https://periopsim.com).
15868408|NCT03894631|Procedure|KDB/Phacoemulsification|50 eyes of 50 patients will receive combined KDB/phaco surgery
15868409|NCT03894631|Procedure|Trabectome/Phacoemulsification|The contralateral 50 eyes of the same 50 patients will receive combined Trabectome /phaco surgery
15868410|NCT03894618|Drug|SL-279252|The investigational product (IP), SL-279252, is a first-in-class agonist redirected checkpoint (ARC) fusion protein (FP) consisting of the extracellular domains of human programmed cell death 1 (PD- 1) and OX40L, linked by a central Fc domain (PD1-Fc-OX40L).
15868411|NCT03894605|Device|thalassemia|thalassemic patient use chelator and thaladssemic patient with frequent blood transfusion
15868412|NCT03894592|Other|Virtual reality|Trauma patients enrolled in the study will be offered Virtual Reality experieince per the protocol
15868413|NCT03894579|Biological|Study Product: SNK01|SNK01 administered using an intravenous line (IV) to all patients at weeks 1, 2, 3, and 4
15868414|NCT03894566|Other|No intervention - birth cohort study|There are no interventions because it is a birth cohort study
15868415|NCT03894553|Device|ExAblate Neuro|Unilateral stereotactic focused ultrasound lesioning of the contralateral mesencephalon
15868416|NCT03894540|Drug|IPN60090|Oral capsules given daily
15868417|NCT03894540|Drug|pembrolizumab|An intravenous solution in single-use vial to be diluted for infusion.
15868418|NCT03894540|Drug|paclitaxel|An intravenous solution in single-use vial to be diluted for infusion.
15868419|NCT03894540|Drug|IPN60090 single administration|Oral capsules given once
15868420|NCT03894527|Behavioral|Single Bout of Exercise|An exercise condition, which will be walking at a moderate intensity (~70% VO2peak). Time will vary based upon individual fitness levels to burn ~400kcals (estimated 0.5 - 1hr). Oxygen consumption will be measured during exercise via a metabolic cart to confirm energy expenditure. Participants will then rest following the exercise procedure for 20 minutes. Between 20 and 45 minutes following exercise, oxygen consumption will be measured to understand and capture excess post-exercise oxygen consumption (EPOC). Following this, participants will be provided with a standardize dinner and snack to consume in the AMP lab.
15868421|NCT03894527|Behavioral|Control Condition|A control (no-exercise) condition. Participants will report to the AMP lab to rest for the same duration as the exercise bout and consume the standardized dinner and snack.
15868422|NCT03894501|Behavioral|Mindfulness Oriented Recovery Enhancement|MORE sessions involve mindfulness training to prevent opioid relapse and reduce pain, cognitive reappraisal to decrease negative affect and regulate opioid craving, and savoring to augment natural reward processing and evoke positive emotion. Each session begins with a mindful breathing meditation, followed by a debriefing session. The therapist then debriefs participants' homework practice of using mindfulness, reappraisal, and savoring skills to cope with pain and enhance well-being in everyday life. During this debrief of the homework. Next, new psychoeducational material is introduced. Sessions culminate with an experiential exercise, and close with a brief mindful breathing meditation. Participants are asked to practice 15 minutes of mindfulness/reappraisal/savoring skills each day.
15868423|NCT03894501|Behavioral|Methadone program behavioral treatment as usual|In the methadone programs, clients typically come to the clinic regularly to get their methadone dose. Clients see their clinic substance abuse counselor for individual counseling, usually weekly at the beginning of treatment, with decreasing frequency if they remain abstinent and progress through treatment. Depending on clients' stage of MMT and success with remaining abstinent from drugs, they may be required to attend clinic treatment groups. Also, some clients may choose to go to voluntary counseling, educational, or support groups.
15868424|NCT03894488|Diagnostic Test|FilmArray Gastrointestinal (GI) Panel|The FilmArray GI Panel tests for 22 of the most commonly associated pathogens related to gastroenteritis-all from one patient sample, one easy to use reagent, and results are available in about one hour.
15868425|NCT03894475|Device|AioCare|AioCare is an ultraportable, handheld hardware module that contains the MEMS-based flow sensor and electronics, with a dedicated mobile application that works on iOS and Android operating systems. The unit is used with a disposable mouthpiece fitted to the tip of the flow tube, and a nose clip. AioCare is connected to its dedicated mobile application, which contains software that will show flow-volume graphs and results in real time. The device encompasses all of the widely used spirometry parameters, including: peak expiratory flow (PEF), forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC), FEV1/FVC ratio, forced expiratory flow at 25% of expiration (FEF25), forced expiratory flow at 50% of expiration (FEF50), forced expiratory flow at 75% of expiration (FEF75), and forced expiratory volume in 6 second (FEV6).
15868426|NCT03894475|Device|Spirometer USB CPFS/D (MGC Diagnostics)|Spirometer USB CPFS/D (MGC Diagnostics) is a diagnostic desktop spirometer used in hospitals/clinics. CPFS/D USB spirometer is compatible with desktop and laptop computers.
15868427|NCT03894462|Behavioral|Attempted Suicide Short Intervention Program|ASSIP is a manualized, three-session intervention, delivered either in-person or via telehealth: In Session 1, the therapist guides the patient in telling the story of their attempt. The session is video recorded. In Session 2, the therapist and patient sit side-by-side to view selections of the video, working together to understand the feelings and events that preceded the attempt. The patient is assigned a homework task. In Session 3, the therapist and patient create a summary of the suicide attempt and what led up to it, along with creating a personal safety plan.
15868524|NCT03893695|Drug|GT90001 and Nivolumab|Stage1:Dose de-escalation. Stage2:the expansion cohort where one or no DLT takes place in planned study cohort.
15868428|NCT03894462|Behavioral|Zero Suicide Usual Care|Participants will have access to outpatient treatment in facilities that are adopting NYS Zero Suicide protocols. Those who do not engage in care will nonetheless experience enhanced transition and follow-up contact from the services from which they are discharged.
15868429|NCT03894449|Combination Product|Prebiotic + Iron Forificant|A combination dosage of prebiotic (Inulin or GOS) and Iron Fortificant (FeSO4 or NaFeEDTA) will be given to the study subjects.
15868430|NCT03894436|Combination Product|Ultrasound assessment of diaphragm thickness in B-mode|assess the thickness of diaphragm needed as a tool for prediction of extubation and proper timing of weaning from mechanical ventilation in the ICU which is measured by B mode ultrasound in ventilated cancer patients
15868431|NCT03894397|Device|Electrical stimulation of the BNST|Electrical stimulation of the BNST
15868432|NCT03894384|Diagnostic Test|Trefoil factor family 3 (TFF3),Pepsinogen 1(PG1)|Diagnostic Test: A) CBC . B) FBG. C)KFT. D) LFT. A)CBC: Complete blood count. B)FBG: Fasting blood glucose. C)KFT: Kidney function tests. D)LFT: Liver function tests.
15868433|NCT03894371|Device|Thermage FLX|Thermage FLX system for the correction of mild to moderate laxity of the skin of the face, neck, and eyelids.
15868434|NCT03894358|Dietary Supplement|FeFum and 7.5 g prebiotic mixture|"The 3 weeks intervention will consist of 24 g of wheat-based instant cereal and 90 ml of water per portion and will contain 3.6 mg FeFum and AA (molar ratio Fe:AA between 2.5 and 3) plus 7.5 g prebiotics mixture
~The absorption study test meals will consist of 24 g wheat-based instant cereal and 90 ml of water per portion and additionally:
~Test meal 1 will be composed of: 3.6 mg of Fe as 57FeFum and 0 g prebiotic mixture added extrinsically.
~Test meal 2 will be composed of: 3.6 mg of Fe as 1.5 mg iron as 58FeFum, 2.09 mg iron as 56FeFum and 7.5 g prebiotic mixture added extrinsically."
15868435|NCT03894358|Dietary Supplement|FeFum and 3 g prebiotic mixture|Standard wheat-based instant cereal containing 3.6 mg FeFum and AA (molar ratio Fe:AA between 2.5 and 3) plus 3 g prebiotics mixture per portion
15868436|NCT03894358|Dietary Supplement|Fefum and no prebiotic mixture|Standard wheat-based instant cereal containing 3.6 mg FeFum and AA (molar ratio Fe:AA between 2.5 and 3) per portion.
15868437|NCT03894345|Drug|Prazosin|Competitive alpha-1 adrenergic receptor blocker which has been used to treat PTSD and Benign Prostatic Hypertrophy
15868438|NCT03894332|Diagnostic Test|Electrical Impedance Tomography (EIT)|"After enrollment, a silicon EIT belt of proper size with 16 electrodes was placed around the patient's chest between the 4th and 6th intercostal spaces, and connected to the EIT device. All patients were ventilated in Pressure Support Ventilation (PSV) mode, with a dedicated ventilator connected to the EIT device.
~We acquired 5-min EIT data records at baseline (during PSV), during the first (SBT_0) and the last (SBT_30) 5 minutes of SBT, and, when the patient was extubated, during spontaneous breathing soon after (SB_0) and 30 minutes after extubation (SB_30).
~EIT and ventilator data were recorded at a sample of 20 Hz. The last 3 minutes of each record were analyzed.
~We measured respiratory rate (RR); Vt changes from baseline, expressed as percent (dVt%); dEELI variations from baseline, expressed in mL; the Global Inhomogeneity index (GI); Impedance ratio (IR) and the Center of Ventilation (CoV)."
15868439|NCT03894306|Other|Medication lock box|given a lock box and instructed on how to use the device.
15868440|NCT03894306|Other|medication lock bag|given a lock bag and instructed on how to use the device.
15868441|NCT03894306|Other|brief counseling|After completing the per-intervention survey, a research assistant or investigator will perform brief counseling, including educational handouts and information on safe medication storage
15868442|NCT03894280|Drug|Fluticasone propionate 250 mcg and salmeterol xinafoate 50 mcg inhalation powder/Respirent Pharmaceuticals|2 inhalations in one study period
15868443|NCT03894280|Drug|SERETIDE DISKUS® 250/50 inhalation powder/GSK|2 inhalations in one study period
15868444|NCT03894280|Other|Activated Charcoal suspension|oral suspension before and after inhalation of study Investigational Products
15868445|NCT03894267|Device|Cutimed Siltec Heel and Sacrum dressing|The dressing has been developed to facilitate exudate management in the treatment of wounds. Newly formed tissue enjoys optimal protection under a moist environment. The foam core with super-absorbers ensures reliable absorption in slightly to heavily exuding wounds. This core has an excellent retention capacity, even under compression. Hydrogen bridges bind the water so securely that, even when subject to pressure, the water is not released. Vertical absorption through the polyurethane foam and the hydro- phobic wound contact layer minimizes the risk of macerations in the peri-ulcer skin.
15868446|NCT03894254|Other|no intervention|This is study carried out in current practice. Patients are undergoing a medical examination in a memory center, with extensive and systematic evaluations for the study involving the following tests: IADL, DAD6, New AGGIR, NPI, and mini-Zarit) assessing the functions (autonomy, behavior and caregiver burden).
15868447|NCT03894241|Behavioral|physical activity|"Participants will assist to the three different sessions at the same weekday (e.g., Monday) and at the same daytime to avoid differences in preceding school activities or circadian rhythms. Participants will undergo a Sedentary condition (SC), sitting and watching a documentary on TV as has been used previously, and two different PA protocols consisting in Moderate-Intensity Continuous Training (MICT), i.e., continuous outdoor walking, and Cooperative High-Intensity Interval Training (C-HIIT), composed of a circuit training with a partner (physical education teacher)"
15868448|NCT03894215|Drug|AGEN2034|PD-1 antibody
15868449|NCT03894215|Drug|AGEN1884|CTLA-4 antibody
15868450|NCT03894189|Drug|Doxapram Hydrochloride|the diaphragmatic function will be assessed measuring right and left diaphragmatic thickening fraction in the two groups to be compared as a primary outcome using ultrasound. following the administration of the selected drug
15868451|NCT03894189|Drug|Theophylline|the diaphragmatic function will be assessed measuring right and left diaphragmatic thickening fraction in the two groups to be compared as a primary outcome using ultrasound. following the administration of the selected drug
15868452|NCT03894176|Other|Plasma PTX3 concentration|Long pentraxin 3, thrombus burden, final TIMI flow, ST segment resolution, STEMI, primary PCI
15868453|NCT03894150|Drug|F0002-ADC|Every 21 days for 1 cycle, continue treatment until a maximum 16 cycles. Dose Escalating: 0.3 - 4.8 mg/kg
15868454|NCT03894137|Dietary Supplement|Grains of Paradise (Aframomum Melegueta)|This is a randomized, double blind, crossover design testing the effect of grains of paradise on resting energy metabolism
15868455|NCT03894124|Drug|Doravirine|Non-nucleoside reverse transcriptase inhibitor. Administered as film coated tablet.
15868461|NCT03894059|Other|Educational Intervention|Additional training provided to ambulance telecommunicators in participating sites to help increase recognition of agonal breathing in the presence of out-of-hospital cardiac arrest.
15868462|NCT03894046|Drug|ETX2514/Sulbactam + Imipenem/Cilastin|1.0 g ETX2514/1.0 g sulbactam IV infused over 3 hours q6h plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h
15868463|NCT03894046|Drug|Colistin + Imipenem/Cilastin|2.5 mg/kg colistin IV infused over 30 minutes q12h (after an initial loading dose of colistin 2.5 to 5 mg/kg) plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h.
15868464|NCT03894046|Drug|ETX2514/Sulbactam + Imipenem/Cilastin|1.0 g ETX2514/1.0 g sulbactam IV infused over 3 hours q6h plus 1.0 g imipenem/1.0 g cilastatin IV infused over 1 hour q6h.
15868465|NCT03894033|Device|Ascyrus Medical Dissection Stent (AMDS)|The device will be implanted during already planned surgical intervention for aortic dissection repair. The participant will be observed and data gathered during the surgery and routine standard of care follow up visits.
15868466|NCT03894007|Drug|Docetaxel|75 mg/m2 iv, escalated to 100 mg/m2 if tolerated, day 1 every third week, 4 courses preoperatively.
15868467|NCT03894007|Drug|Carboplatin|AUC 6 iv, day 1 every third week, 4 courses preoperatively.
15868468|NCT03894007|Drug|Trastuzumab|600 mg sc, day 1 every third week, 4 courses preoperatively. 14 courses postoperatively if complete response.
15868469|NCT03894007|Drug|Pertuzumab|840 mg iv starting dose, thereafter 420 mg, day 1 every third week. 14 courses postoperatively if complete response in patients with baseline high risk tumours.
15868470|NCT03894007|Drug|Epirubicin|90 mg/m2 iv, escalated to 100 mg/m2 if tolerated, day 1 every third week, 3 courses preoperatively
15868471|NCT03894007|Drug|Cyclophosphamide|600 mg/m2 iv, day 1 every third week, 3 courses preoperatively
15868472|NCT03894007|Drug|Atezolizumab|840 mg iv, day 1 every third week, 3 courses preoperatively if randomised to arm A.
15868473|NCT03894007|Drug|Trastuzumab emtansine|3.6 mg/kg iv, day 1 every third week, 14 courses postoperatively if not complete response.
15868474|NCT03894007|Drug|Paclitaxel|80 mg/m2 iv, day 1 weekly, 12 weeks (4 cycles), in case of (anticipated) unmanageable toxicity related to docetaxel.
15868475|NCT03893994|Other|Stretching exercises|Stretching exercises will be applied 6 days a week, 30sec / 5 reps
15868476|NCT03893981|Other|Proprioception and Balance Program|Balance Trainer device and playing ball in tandem position for using to improve balance, vibration and reposition exercises for using to improve proprioception. Progressive of training will increase after each 2 weeks.Patients will be taken to the treatment program 3 days in a week for 8 weeks.
15868477|NCT03893981|Other|Strengthening Program|Exercises which include open and closed kinetic chain exercise will be applied to strength knee and hip muscle. Progressive of training will increase after each 2 weeks. Patients will be taken to the treatment program 3 days in a week for 8 weeks.
15868478|NCT03893968|Behavioral|Information by an assistant nurse|Information received by patients after ambulatory hand surgery under local anaesthetic about postoperative self care given by an assistent nurse.
15868479|NCT03893968|Behavioral|Information by a doctor|Information received by patients after ambulatory hand surgery under local anaesthetic about postoperative self care given by a doctor.
15868480|NCT03893955|Drug|ABBV-927|Intravenous (IV) Infusion
15868481|NCT03893955|Drug|ABBV-368|Intravenous (IV) Infusion
15868482|NCT03893955|Drug|ABBV-181|Intravenous (IV) Infusion
15868483|NCT03893955|Drug|Carboplatin|Intravenous (IV) Infusion
15868484|NCT03893955|Drug|Nab-paclitaxel|Intravenous (IV) Infusion
15868485|NCT03893942|Other|Questionnaires administration|Psychological and quality of life questionnaires
15868486|NCT03893942|Other|Langer Mindfulness Scale (LMS)|The LMS is a 21-item questionnaire, assessing four domains associated with mindful thinking: novelty-seeking, engagement, novelty producing, and flexibility.
15868487|NCT03893942|Other|Mindful Attention Awareness Scale (MAAS)|The MAAS is a 15-item questionnaire, designed to assess a core characteristic of dispositional mindfulness, namely, open or receptive awareness of and attention to what is taking place in the present
15868488|NCT03893942|Other|Cognitive Flexibility Scale (CFS)|The CFS is 12-item self-report test assessing awareness.
15868489|NCT03893942|Other|Life Orientation Test (LOT)|The LOT is a 10-item, self-administered scale assessing generalized expectancies for positive versus negative outcomes.
15868490|NCT03893942|Other|Mini Locus of Control test (MLS)|The MLS is a 6-item questionnaire that includes 3 factors : chance, powerful others, and internality.
15868491|NCT03893942|Other|Hospital Anxiety and Depression Scale (HADS)|The HADS is a 14-items rated on a four-point Likert scale. The questionnaire was designed to screen for the presence and severity of depression (HADS-D) and anxiety (HADS-A) in people with a physical symptomatology
15868492|NCT03893942|Other|Perceived Stress Scale (PSS)|The PSS is 14-item self-report tool commonly used to provide a global measure of perceived stress in daily life.
15868493|NCT03893929|Diagnostic Test|New Biological markers for prostate cancer diagnosis and management|To identify potential new blood and urine markers for the diagnosis, risk stratification and prognosis prediction for prostate cancer in Chinese population.
15868494|NCT03893916|Procedure|MEG - EEG HR|"MEG : Magnetoencephalography is the study of the magnetic fields produced by the electrical activity of the brain.
~MEG signals are obtained while the patient is placed in a device specific to this technique. The latter comprises a recording chamber, recording sensors which are placed in a cryostat and an electronic measuring system. The magnetic fields are measured while the subject is placed in a shielded magnetic chamber protecting it from variations in the ambient magnetic field (displacement of metal masses, sector ...).
~EEG HR: High Resolution EEG is defined as the recording of cerebral electrical activity with 128 electroencephalographic electrodes and with high temporal resolution usually followed by the use of source localization tools. The HR EEG is therefore derived from standard EEG techniques, but requires a higher number of electrodes and the use of source localization tools."
15868495|NCT03893903|Drug|IDH1R132H peptide vaccine|"The vaccine is applied by s.c. injection with 300 μg IDH1R132H peptide emulsified in 0.5 ml 33% DMSO / 0.5 ml Montanide® per dose.
~Patients receive 3 doses in two week intervals for 6 weeks, followed by re-resection. 4 weeks after surgery, treatment will be resumed consisting of 5 additional vaccinations in 4 week intervals, followed by maintenance vaccines until progression in three months intervals after a pause of 16 weeks."
15868858|NCT03891095|Drug|L-DOPA|orally administered
15868496|NCT03893903|Drug|Avelumab|"Avelumab is a humanized anti-PD-L1 antibody approved for patients with Merkel cell carcinoma and urothelial cancer. It is applied by i.v. infusion with 10 mg/kg per dose.
~Patients receive 3 doses of Avelumab in 2week intervals for 6 weeks, followed by re-resection. Avelumab will be administered in monthly intervals starting 4 weeks after the surgery until progression."
15868497|NCT03893890|Biological|Previously Treated with EN3835|No treatment to be administered - Observational only
15868498|NCT03893877|Device|nasal cannula|experimental group will be applied nasal cannula
15868499|NCT03893877|Device|nasal mask|active comparator group will be applied nasal mask
15868500|NCT03893864|Dietary Supplement|Administration of a product with Fitosomed Ubiquinone|Healthy runner athletes, > 50 years old, without any chronic illness, without any other nutritional supplementation or drug intervention, took 100 mg/d of fitosomed Ubiquinone with lunch, daily, during one month, maintaining their usual training sessions.
15868501|NCT03893864|Procedure|Coenzyme Q10 level in muscle biopsies|Determination of the muscle Ubiquinone concentration, the metabolic and structure characteristics of the muscle before and after one month of supplementation
15868502|NCT03893864|Diagnostic Test|Coenzyme Q10 level in plasma, blood cells, urine cells|Determination of Ubiquinone concentration in different tissues before and after one month of supplementation or not
15868503|NCT03893864|Diagnostic Test|Total antioxidant capacity after strenous exercise|Determination of the Total Antioxidant Capacity after strenous exercise in the Climate Chamber
15868504|NCT03893851|Behavioral|Interactions Competencies with Children - for Teachers (ICC-T)|Core training components include teacher-student interaction, maltreatment prevention, effective discipline strategies, identifying and supporting burdened students and implementation of the training materials into the school setting.
15868507|NCT03893812|Device|MRI|diffusion weighted MR
15868508|NCT03893812|Device|Ultrasound|Color Doppler ultrasound
15868509|NCT03893799|Drug|Iron sucrose (FeS) and Stannous Protoporphyrin (SnPP)|Escalating doses of iron sucrose and stannous protoporphyrin
15868510|NCT03893786|Device|Robotic Rehabilitation|"Fifteen patients with Parkinson's Disease will perform ten 45-minute training sessions of the upper limb bilaterally with the Armeo®Spring, an electromedicad device aimed at improving force and coordination in neurologically affected patients.
~The device was built to sustain the forearm during the upperlimb training and is equipped with a VR screen with which the patient may interact during the playful and motivating rehab."
15868511|NCT03893773|Device|doppler ultrasonagraphy|"The following parameters will be measured:
~Hepatic artery Resistance index (HARI), Diameter, peak systolic velocity (HAPSV, cm/s).
~Portal vein peak velocity (PVPV) and diameter at the anastomotic and non-anastomotic sites.
~Hepatic vein peak velocity and wave form"
15868512|NCT03893760|Diagnostic Test|Ventriculo-arterial coupling assessment (R-V/A)|R-V/A was achieved by computing the R-Elv/P-Ea ratio (Right ventricular elastance/Pulmonary arterial elastance). R-Elv was computed as PAPm / end-systolic area (ESA) of the right ventricle. P-Ea was obtained as (PAPm-PCWP)/ right ventricle stroke volume (R-SV).
15868513|NCT03893747|Biological|The first batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor|500 subjects will be randomized to receive the first batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor
15868514|NCT03893747|Biological|The second batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor|500 subjects will be randomized to receive the second batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor
15868515|NCT03893747|Biological|The third batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor|500 subjects will be randomized to receive the third batch of inactivated EV-A71 vaccine (vero cell) producted by 40 L reactor
15868516|NCT03893747|Biological|The first batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor|500 subjects will be randomized to receive the first batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor
15868517|NCT03893747|Biological|The second batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor|500 subjects will be randomized to receive the second batch of inactivated EV-A71 vaccine (vero cell) producted by 150 L reactor
15868518|NCT03893747|Biological|The third batch of inactivated EV-A71 vaccine (vero cell) proudected by 150 L reactor|500 subjects will be randomized to receive the third batch of inactivated EV-A71 vaccine (vero cell) proudected by 150 L reactor
15868519|NCT03893734|Drug|methadone|Patients in the methadone group will receive a syringe of methadone at induction of anesthesia and a syringe of saline at the end of anesthesia
15868520|NCT03893734|Drug|Hydromorphone|Patients in the hydromorphone group will receive a syringe of saline at induction of anesthesia and a syringe of hydromorphone at the end of anesthesia
15868521|NCT03893721|Diagnostic Test|arsenic exposure|analysis of hair samples for Arsenic using Agilent graphite tube atomizer 120
15868522|NCT03893708|Behavioral|Prenatal yoga|The prenatal yoga classes will be offered at Urban Wellness (2024 N. 7th St., Phoenix, AZ 85006). Classes will be offered Tuesdays's from 4:15-5:30 pm and Saturday's from 9:00-10:15 am. Participants will be able to attend both classes if they so choose but are only asked to attend 1/week. Participants will be asked to arrive to class at least 10 minutes early in order for the research team to collect their weight in a private room. Additionally, if participants have attended at least 70% of classes (1 per week for 8/12 weeks), participants will be able to attend sessions up until birth (beyond the 12-week intervention) if they so choose. If participants decide to attend classes beyond the 12-week intervention the investigators will continue to collect their weight at each session.
15868523|NCT03893708|Behavioral|Pregnancy education|Pregnancy education classes will be offered at the Arizona Biomedical Collaborative Building on ASU Phoenix Campus. Classes will be offered on Tuesday's from 5:30-6:45 pm and Saturday's from 9:00-10:15 am. Participants will be able to attend both classes if they so choose but are only asked to attend 1/week. Participants will be asked to arrive to class at least 10 minutes early in order for the research team to collect their weight in a private room. Additionally, if participants have attended at least 70% of classes (1 per week for 8/12 weeks), participants will be able to attend sessions up until birth (beyond the 12-week intervention) if they so choose. If participants decide to attend classes beyond the 12-week intervention the investigators will continue to collect their weight at each session.
15868572|NCT03893357|Other|Data extraction from medical files|Retrospective data extraction from the medical files
15868525|NCT03893682|Drug|CG-806|CG-806 will be given orally in ascending doses starting at 150 mg PO BID until the maximum tolerated dose or recommended dose is reached.
15868526|NCT03893669|Biological|NBP607|1 dose, 0.5ml, Intramuscular (IM) injection
15868527|NCT03893669|Biological|Agrippal|1 dose, 0.5ml, Intramuscular (IM) injection
15868528|NCT03893643|Other|no intervention|no intervention in an observational study
15868529|NCT03893630|Drug|Acetylsalicylic Acid 81 mg|Patients will receive 81mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.
15868530|NCT03893630|Drug|Acetylsalicylic Acid 162 mg|Patients will receive 162mg acetylsalicylic acid daily, initiated between 11 and 16 weeks of gestation and continued until 36 weeks of gestation.
15868531|NCT03893630|Other|Control|Standard of Care
15868532|NCT03893617|Drug|Propranolol|A single oral dose (80mg) of propranolol will be administered in a blinded capsule at the start of the baseline monitoring period of the acute stress study visit.
15868533|NCT03893617|Drug|Placebo oral capsule|A single blinded capsule containing no active medication will be administered at the start of the baseline monitoring period of the acute stress study visit.
15868534|NCT03893617|Behavioral|Acute stress task|Participants will complete speech and arithmetic tasks, performed in front of an audience (e.g., researcher staff members) and recorded by a video camera to assess non-verbal behaviors and evaluate performance. The task will be initiated following completion of baseline sample collection during the acute stress study visit and will take approximately 15 minutes.
15868535|NCT03893617|Behavioral|No stress task|Participants will sit quietly for 5 minutes, read a short passage aloud for 5 minutes, and read a list of numbers aloud for 5 minutes. The task will be initiated following completion of baseline sample collection during the no stress study visit and will take approximately 15 minutes.
15868536|NCT03893604|Device|tDCS|20 minutes of anodal tDCS (C3/FP2) 2mA or sham
15868537|NCT03893591|Diagnostic Test|Anti Xa levels|one Blood sample
15868538|NCT03893578|Device|Mitral valve-in-valve|The Synecor Conveyor System shall be used to position the Edwards SAPIEN 3 valve at the mitral location.
15868539|NCT03893565|Drug|GSK2831781 - Double Blind Phase|GSK2831781 will be administered intravenously in the double blind induction phase and subcutaneously in the double blind ETP (both according to randomization).
15868540|NCT03893565|Drug|Placebo|Placebo (commercial saline solution) will be administered intravenously in the double blind induction phase and subcutaneously in the double blind ETP (both according to randomization).
15868541|NCT03893565|Drug|GSK2831781 - Open Label phase|GSK2831781 will be administered intravenously in the open label induction phase and subcutaneously in the open label ETP.
15868542|NCT03893552|Device|Negative expiratory pressure|Using a cough assist, a negative expiratory pressure will be applied while recording the respiratory flow in patients suffering from sleeping disorders or snoring.
15868543|NCT03893539|Device|Ion Endoluminal System™|The Ion™ Endoluminal System, Model IF1000, is a software-controlled, electro-mechanical system designed to assist qualified physicians to navigate a catheter and endoscopic tools in the pulmonary tract using endoscopic visualization of the tracheobronchial tree for diagnostic and therapeutic procedures.
15868544|NCT03893526|Drug|Entresto|Single dose administration of entresto
15868545|NCT03893526|Drug|Sitagliptin|Single dose administration of sitagliptin
15868546|NCT03893526|Drug|Valsartan|single doses administration of valsartan
15868547|NCT03893526|Drug|Placebo|placebo day
15868548|NCT03893513|Device|Transthoracic Electrical Bioimpedance|Non-invasive hemodynamic monitor
15868549|NCT03893513|Device|Pulse Contour Analysis|Invasive hemodynamic monitor
15868550|NCT03893500|Device|Home-based 6 minute walk test|Participants will receive a loaner Apple Watch with the Walk.Talk.Track. (WTT, produced by PHaware) app downloaded. Participants will perform a daily 6MWT at home using the Apple Watch and WTT app. They will undergo a history and physical, blood draw, echocardiogram and in-clinic 6MWT at the baseline and 12-week follow up visit.
15868551|NCT03893487|Drug|Fimepinostat|Fimepinostat capsules
15868552|NCT03893487|Procedure|Therapeutic Conventional Surgery|Undergo surgery
15868553|NCT03893474|Diagnostic Test|OCT|Optical Coherence Tomography of study eye.
15868554|NCT03893474|Diagnostic Test|Visual Acuity|Visual acuity measured by ETDRS
15868555|NCT03893461|Radiation|x|Stereotactic body radiation therapy for localized NSCLC
15868556|NCT03893448|Biological|V114|V114 15-valent pneumococcal conjugate vaccine containing 13 serotypes present in Prevnar 13® (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL intramuscular administration.
15868557|NCT03893448|Biological|Prevnar 13™|Prevnar 13™ 13-valent pneumococcal conjugate vaccine containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL IM administration.
15868558|NCT03893448|Biological|RotaTeq™|A total of 3 RotaTeq™ 2 mL oral dosings at ~2, ~4, and ~6 months of age.
15868559|NCT03893448|Biological|Pentacel™|A total of 3 Pentacel™ 0.5 mL IM dosings at ~2, ~4, and ~6 months of age.
15868560|NCT03893448|Biological|RECOMBIVAX HB™|A total of 3 RECOMBIVAX HB™ 0.5 mL IM dosings at ~2, ~4, and ~6 months of age.
15868561|NCT03893448|Biological|VAQTA™|One VAQTA™ 0.5 mL IM dosing at 12 to 15 months of age.
15868562|NCT03893448|Biological|MMR II™|One MMR II™ 0.5 mL subcutaneous (SC) dosing at 12 to 15 months of age.
15868563|NCT03893448|Biological|VARIVAX™|One VARIVAX™ 0.5 mL SC dosing at 12 to 15 months of age.
15868564|NCT03893448|Biological|HIBERIX™|One HIBERIX™ 0.5 mL IM dosing at Visit 5.
15868565|NCT03893435|Drug|Sacubitril / Valsartan Oral Tablet [Entresto]|Sacubitril/Valsartan with the recommended starting dose: 24 mg/26 mg PO BID. After 2-4 weeks, the dose will be doubled to the target maintenance dose of 97 mg/103 mg PO BID (if tolerated) for 6 months.
15868566|NCT03893422|Other|WB-010|Medical food formulation
15868567|NCT03893422|Other|WB-011|WB-011 medical food product
15868568|NCT03893422|Other|Placebo|Placebo Capsules identical to those containing WB-010 and WB-011.
15868569|NCT03893396|Device|Coronary angioplasty|Procedure used to open clogged heart arteries. Involves the insertion of a tiny balloon and/or a stent to widen the artery.
15868573|NCT03893344|Diagnostic Test|detection of STAT4 gene|Individuals within both groups will be subjected to STAT4 gene polymorphism typing using both PCR and flow cytometry from a peripheral blood sample
15868574|NCT03893331|Device|AcQMap System|To evaluate procedural and long-term outcomes when using the diagnostic AcQMap System as an imaging and mapping system for ablation of arrhythmias in accordance with the Instructions for Use (IFU).
15868575|NCT03893318|Drug|IV lidocaine|an amide-type, short-acting local anesthetic and delivered as an aqueous solution for intravenous administration. It has a half-life of 1.5-2 hours. A traditional method of administration is via epidural delivery. Epidural lidocaine is effective and this effect is due, in part, to systemic absorption. Systemic (intravenous) administration of lidocaine is a Food and Drug Administration approved method of delivery. Low plasma levels are needed for effective use, 0.5µg/mL to 5.0µg/mL. Given this low concentration required and the short half-life, continuous infusion of lidocaine is thought to be generally safe with low risk of complication.
15868576|NCT03893318|Drug|Placebos|Saline
15868577|NCT03893292|Procedure|Total knee replacement|Patients will undergo total knee replacement surgery.
15868578|NCT03893292|Device|COOLIEF|The superior lateral genicular nerve, superior medial genicular nerve, and inferior medial geniculate nerve will be ablated.
15868579|NCT03893279|Behavioral|Smell and Taste and questionnaire|The questionnaire must be completed before the antibiotic is taken, if a change of antibiotic is planned (stop of a treatment or addition of another treatment) and at the end of the antibiotic treatment.
15868580|NCT03893266|Other|Interviews|An interview will be realized with each patient in order to precise the issues they have to reconcile their diabetes and their work. Some questions will be posed to the patients and they respond as they wish.
15868581|NCT03893253|Other|Early Booster Teaching|The early booster group will receive a booster teaching session at 3 weeks post-training followed by feedback.
15868582|NCT03893253|Other|Late Booster Teaching|The late booster group will receive a booster teaching session at 2 months post-training followed by feedback
15868583|NCT03893240|Diagnostic Test|Neutralizing Antibody to SPK-3006 capsid|Collected during a single study visit to establish the occurrence of neutralizing antibodies to SPK-3006 capsid in participants with LOPD on an enzyme replacement regimen.
15868584|NCT03893227|Other|Questionnaire|Patients and healthy controls will fill out a questionnaire
15868585|NCT03893214|Behavioral|virtual reality exposure for acrophobia|"The setting of the virtual reality is the Gasometer Oberhausen, Europe's largest disc-type gas container which is one of the most famous high buildings in the area. After a baseline phase, participants will undergo a gradual exposure. Participants will first look up to the building and then be guided upstairs to have an exposure phase on 11 floors. On the highest floor they will walk around a gallery. In the end, there will be a recovery phase."
15868586|NCT03893214|Behavioral|movie|Participants will watch a movie without height content for the same amount of time as the virtual reality exposure will need.
15868587|NCT03893201|Other|Questionnaires|Questionnaires to assess quality of life
15868588|NCT03893175|Drug|Ibuprofen|400 mg by mouth every 4 hours for 2 days after third molar extraction and then as needed for pain up to 7 days after third molar extraction
15868589|NCT03893175|Drug|Acetaminophen|500 mg by mouth every 4 hours for 2 days after third molar extraction and then as needed for pain up to 7 days after third molar extraction
15868590|NCT03893175|Drug|Placebo|By mouth
15868591|NCT03893175|Drug|Oxycodone|5 mg by mouth every 6 hours as needed for pain
15868592|NCT03893162|Dietary Supplement|Multi-strain probiotic|"The intervention in this study is a multi-strain probiotic which contains:
~Bacillus subtilis, Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium longum, Lactobacillus acidophilus, Lactobacillus delbrueckii ssp. bulgaricus, Lactobacillus casei, Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus helveticus, Lactobacillus salivarius, Lactococcus lactis ssp. lactis, Streptococcus thermophilus.
~Each capsule contains minimum 2 billion live microorganisms per capsule, equivalent to 10 billion live microorganisms per gram."
15868593|NCT03893162|Other|Placebo|Visually identical capsules in identical packaging containing no active bacteria.
15868594|NCT03893149|Behavioral|Active-Start intervention|Supervised exercise training. The intervention is a physical activity intervention that consist of 5 times per week before starting the first school-class (8:00-8:30 a.m.), 5 times per week. Each session was previously planned and described in a manual dedicated to the study. These sessions were designed by the research team and delivered by a graduate in Sport The intervention program included sports games adapted to the age of the participants, playground games, dance and other recreational activities. The intensity of the main part of the sessions was moderate-to-vigorous according to a previous study and this intensity was confirmed by accelerometry. Also, different activities favoring social interactions were designed to facilitate the interactions between the participants at the end of the sessions (cold-down).
15868595|NCT03893149|Behavioral|No Intervention|No-exercise
15868596|NCT03893136|Biological|Tocilizumab|The scramble TA group is given bioagents such as IL-6R antibody, CD20-antibody, TNF-alpha antibody, and other bioagents which are safe to use in human to treat other refractory diseases. The sham group is given cyclophosphamide. And the prednisone is the basic drugs to be used in TA.
15868597|NCT03893136|Drug|Leflunomide|The scramble TA group is given new molecules such as Leflunomide, Iguratimod, and other molecules which are safe to use in human to treat other refractory diseases. The sham group is also given cyclophosphamide. And the prednisone is the basic drugs to be used in TA.
15868598|NCT03893123|Other|Observational study, prostate cancer is outcome of interest|Observational study
15868599|NCT03893110|Procedure|surgical stabilization of the spine due to primary and secondary spinal tumors|Posterior instrumentation with pedicle screw system
15868600|NCT03893097|Drug|Praziquantel|40 mg/kg at baseline
15868601|NCT03893097|Drug|Artesunate + Mefloquine|4mg/kg artesunate and 8 mg/kg mefloquine at baseline (3 consecutive days) and repeated at Week 6 and Week 12
15868602|NCT03893084|Other|Pregnancy preparation training|Pregnancy preparation education; folic acid use, physical activity, nutrition, addictions counseling issues are included.
15868603|NCT03893071|Drug|Hydroxypropyl-β-cyclodextrin|HP-β-CD will be administered as Trappsol® Cyclo 25% (250mg/mL) by slow intravenous infusion over a period of 8 up to 9 hours.
15868859|NCT03891095|Drug|Placebos|intranasally administrated and orally administered
15882784|NCT03783429|Drug|Digoxin|Digoxin tablets will be given orally
15868604|NCT03893045|Drug|ferumoxytol|Each 20 mL single-use vial contains 17 mL of ferumoxytol that consists of iron at a concentration of 30 mg Fe/mL, coated with polyglucose sorbitol carboxymethylether and formulated with mannitol, at a concentration of 44 mg/mL, in a black to reddish brown sterile, aqueous, colloidal, isotonic solution
15868605|NCT03893045|Drug|Iron sucrose|Each mL contains 20 mg of elemental iron as iron sucrose in water for injection. The 5 mL single-use vial contains 100 mg of iron per 5 mL. The drug product contains approximately 30% sucrose (300 mg/mL).
15868606|NCT03893032|Drug|Modafinil 200mg|single 200 mg dose
15868607|NCT03893032|Drug|mixed amphetamine salts|single 10 mg dose
15868608|NCT03893032|Drug|Placebo|single oral-administration placebo tablet
15868609|NCT03893019|Biological|MB-CART20.1|MB-CART20.1 consists of autologous CD20 Chimeric Antigen Receptor (CAR) transduced CD4/CD8 enriched T cells targeting CD20.positive tumor cells
15868610|NCT03893006|Device|Level of vehicle automation|From no automation of the vehicle to full automation through warnings, shared control and partly automated automation levels.
15868611|NCT03892993|Other|Decision Aid|Use decision aid
15868612|NCT03892993|Other|Questionnaire Administration|Ancillary studies
15868613|NCT03892980|Device|Nipple-Sparing Mastectomy|Nipple-sparing mastectomy using da Vinci Xi Surgical System.
15868614|NCT03892967|Other|E2C2 Collaborative Care|Stepped collaborative care to address moderate and severe levels of sleep disturbance, pain, anxiety, depression, fatigue, and functional decline.
15868615|NCT03892941|Device|Imaged based fitting|Mapping of the electrical input of the cochlear implant will be based on an individualized natural frequency alignment as estimated with imaging methods.
15868616|NCT03892928|Drug|Dexmedetomidine group|Propofol group：2-5 mg/kg.h propofol during the whole colonoscopy； Dexmedetomidine group：0.1mcg/kg continuous infusion for 15min（the patients older than 65 years old, 0.5 mcg/kg was continuous infusion for 15min）, 0.7-1mcg/kg.h during the whole colonoscopy
15868617|NCT03892915|Combination Product|evidence-based depression treatment|We will use a stepped care approach to depression treatment. Participants with clinical depression (defined as PHQ-9>9) will be offered either Problem Solving Therapy (PST) or Antidepressant Therapy (ADT), but those with moderate to moderately severe depression will be recommended PST, while those with severe depression will be recommended ADT. Participants with subthreshold depressive symptoms (PHQ-9: 5-9) will receive depression psychoeducation and continued depressive monitoring.
15868618|NCT03892902|Drug|ACT-541468|Film-coated tablet for oral use at a dose strength of 50 mg.
15868619|NCT03892902|Drug|Zopiclone 7.5 mg|Over-encapsulated to maintain blinding.
15868620|NCT03892902|Other|Placebo|Matching to maintain blinding.
15868621|NCT03892889|Combination Product|Abilify MyCite®|Combination product of aripiprazole tablet embedded with sensor and wearable patch.
15868622|NCT03892876|Diagnostic Test|Auditory High Frequency Tetanizing Stimulation|50 ms tone pips presented at high frequency for 120 seconds
15868623|NCT03892876|Diagnostic Test|Sham Comparator|auditory tone pips with interstimulus interval (ISI) 1 sec
15868624|NCT03892863|Device|active repetitive transcranial magnetic stimulation|High frequency rTMS to induce the long term potentiation in the left dorsolateral prefrontal cortex
15868625|NCT03892863|Device|sham repetitive transcranial magnetic stimulation|High frequency rTMS to induce the long term potentiation in the left dorsolateral prefrontal cortex
15868626|NCT03892850|Behavioral|Nurse prescription|Pharmacological nurse prescription. Subjects are individuals who request a same day consultation for minor acute pathologies and meet the selection criteria
15868627|NCT03892850|Behavioral|Medical prescription|Pharmacological medical prescription. Subjects are individuals who request a same day consultation for minor acute pathologies and meet the selection criteria
15868628|NCT03892837|Procedure|PRP|PRP treatment following the conventional treatment for benign airway stenosis which contain a concentrate of platelet-rich plasma protein derived from whole blood.
15868629|NCT03892837|Procedure|Conventional treatment for benign airway stenosis|Including, but not limited to: laser, high frequency electric knife, argon plasma coagulation (APC), cryotherapy, balloon dilation and metal stent placement
15868630|NCT03892824|Device|Vine™ Embolic Protection System|"The system includes the implant and the Vine™ Inserter (inserter) manufactured by Javelin Medical LTD (Israel). The inserter comprises a Motor Unit and a Needle Unit (Needle Unit) available in two sizes. The system is operable when the Needle Unit is loaded with the implant (labeled Loaded Needle Unit) and connected to the Motor Unit. A flag indicating the needle orientation is attached to the needle luer. The implant is automatically deployed from the needle upon activation of the operating button."
15868631|NCT03892811|Other|Three study conditions|Continuous fluoroscopy (at 30 frames/second) will be used for intermittent periods to capture 10 swallows in the initial sucking sequence of each of three study conditions: 1) Dr. Brown's Ultra-Preemie bottle nipple, 2) Dr. Brown's Preemie bottle nipple, and 3) Dr. Brown's Level 1 bottle nipple.
15868632|NCT03892798|Other|No interventions are planned|No interventions are planned
15868633|NCT03892785|Drug|Prednisone treatment|tapering prednisone regimen
15868634|NCT03892785|Drug|Tocilizumab treatment|Tocilizumab 162 mg/week subcutaneous from W0 to W51 (52 injections)
15868635|NCT03892785|Drug|Methotrexate treatment|"Methotrexate subcutaneous from W0 to W51 (52 administrations).
~W0: 7.5 mg/week
~W1: 0.2 mg/Kg/week
~W2 to W51: 0.3 mg/Kg/week (without exceeding 20 mg/week) Folic acid 10 mg/week, 48h after taking Methotrexate, from W0 to W51"
15868636|NCT03892785|Other|Questionnaires|HAQ, SF-36, FACIT-fatigue
15868637|NCT03892785|Biological|Blood samples|Additionnal blood samples for immunomonitoring
15868638|NCT03892772|Drug|SAS0421a|treatment will be given for 3 days
15868639|NCT03892772|Drug|SAS0421b|treatment will be given for 3 days
15868640|NCT03892772|Drug|SAS0421c|treatment will be given for 3 days
15868641|NCT03892772|Drug|placebo|placebo will be given for 3 days
15868642|NCT03892759|Other|Osteopathic Manipulative Therapy|A set of hands-on techniques used by Osteopathic Physicians for the assessment and treatment of somatic dysfunction.
15868671|NCT03892564|Drug|MC2-01 Cream, no irradiation|One application of MC2-01 Cream. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation
15869143|NCT03888469|Device|Verofilcon A contact lenses|Investigational daily disposable soft contact lenses
15868643|NCT03892746|Device|Active tDCS + task oriented practice|Participants in this arm will receive active tDCS(2mA) to the motor cortex(targeting the triceps) of the weaker upper limb for 2 30 minute cycles during each 2 hour upper limb training session. While receiving tDCS the participant will be performing task oriented practice for the weaker upper limb. Participants will receive these interventions for 5 days a week for 3 weeks.
15868644|NCT03892746|Device|Sham tDCS + task oriented practice|Participants in this arm will receive sham tDCS(0mA) to the motor cortex(targeting the triceps) of the weaker upper limb for 2 30 minute cycles during each 2 hour upper limb training session. While receiving tDCS the participant will be performing task oriented practice for the weaker upper limb. Participants will receive these interventions for 5 days a week for 3 weeks.
15868645|NCT03892733|Behavioral|calorie health education knowledge and skills|45 minute intervention done by health educator to give participants skills to use calorie information posted in fast-food restaurants
15868646|NCT03892720|Other|Quality-of-Life Assessment|Ancillary studies
15868647|NCT03892720|Other|Questionnaire Administration|Ancillary studies
15868648|NCT03892720|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15868649|NCT03892707|Drug|Exposure of interest (within routine clinical practice):Vitamin B complexes Milgamma® and Milgamma® compositum|"Milgamma®: 2 mL injection solution containing thiamin hydrochloride 100 mg, pyridoxine hydrochloride 100 mg, cyanocobalamin 1 mg, lidocaine hydrochloride 20 mg.
~Milgamma® compositum: 1 tablet containing benfotiamine 100 mg, pyridoxine hydrochloride 100 mg."
15868650|NCT03892694|Device|RejuvenAir System|Bronchial metered cryospray using RejuvenAir® System.
15868651|NCT03892694|Other|Sham|Sham control procedure
15868652|NCT03892681|Other|hepatocyte-specific contrast agent, extracellular contrast agent|The type of contrast agent for the 1st MRI will be performed using hepatocyte-specific contrast agent (Primovist). The participant will undergo the 2nd MRI using extracellular contrast agent (Gadovist).
15868653|NCT03892668|Drug|Tranexamic Acid|Patients in the TXA group will be given 15 mg/kg of tranexamic acid (Cyklokapron@; Amoun Pharmaceutical Co., SAE) slowly intravenously 30 min before surgery followed by 10 mg/ kg/h infusion in 500 ml Ringer's by infusion pump till the end of the procedure.
15868654|NCT03892668|Drug|oxytocin|An equal volume of normal saline syringe in a double blinded manner will be intravenously administered to the OXYtocin group 30 min before surgery and will be followed by one ampoule of oxytocin (10 U/mL/amp) (Syntocinon; Aventis Pharmaceutical Co.) will be added to 500 mL Ringer's solution running at a rate of 400 mU/min by infusion pump till the end of the procedure.
15868655|NCT03892668|Drug|placebo|An equal volume of normal saline syringe in a double blinded manner will be intravenously administered to the Oxytocin group 30 min before surgery and will be followed by 500 ml saline infusion during the operation
15868656|NCT03892642|Drug|Avelumab|"Induction phase:
~once weekly for weeks 1-6,
~once every 2 weeks at week 8, 10, and 12
~Maintenance phase:
~Once every week for weeks 1-3
~Once every 2 weeks starting at week 5, until the next BCG treatment"
15868657|NCT03892642|Biological|BCG|"Induction phase (cycle 1):
~• Once weekly for weeks 1-6
~Maintenance phase (Month 3, 6, and 12):
~• Once weekly for 3 weeks"
15868658|NCT03892629|Behavioral|Baduanjin exercise|Participants received Baduanjin exercise. Each Baduanjin exercise session lasts 30 minutes and continues twice a day, 5 times per week for 12 weeks
15868659|NCT03892629|Device|Instrument rehabilitation|Participants received pulmanory rehabilitation by using tri-ball respiratory trainer. Each instrument exercise session lasts 30 minutes and continues twice a day, 5 times per week for 12 weeks
15868660|NCT03892616|Drug|BI 1358894 (B)|Tablet formulation 2 (TF2a), fed
15868661|NCT03892616|Drug|BI 1358894 (C)|Tablet formulation 2 (TF2a), fasted
15868662|NCT03892616|Drug|BI 1358894 (D)|Tablet formulation 2 (TF2b), fed
15868663|NCT03892616|Drug|BI 1358894 (E)|Tablet formulation 2 (TF2b), fasted
15868664|NCT03892616|Drug|BI 1358894 (A)|Tablet formulation 1 (TF1), fed
15868665|NCT03892603|Other|Strengthening exercises program|Participants from this group will be given a progressive shoulder strengthening exercises program based on 1 RM that will involve isometric, concentric and eccentric contractions. The exercises will target shoulder internal/external rotators and abductors and the scapular muscles. They will have to exercise every other day for 12 weeks. At each session with the therapist (6 over a 12 week period), strength will be reassessed and the program will be progressed accordingly. Any questions or concerns will also be addressed and participants will be requested to complete a paper based or digital record of their exercise participation.
15868666|NCT03892603|Other|Motor control exercises program|Each session will start with a series of clinical tests that will look at the influence of different corrections to alleviate symptoms during upper limb movements.The tests will be performed in a sequential format through four key areas: thoracic repositioning, scapula facilitation, humeral head procedures and neuromodulatory techniques. If a correction reduces pain, that technique will then be performed as exercises and incorporated into the participant's functional movement. In addition, motor control exercises during arm elevation, progressed through a standardized 6-phase retraining sequence, will be executed. Retraining phases will be graded according to: 1) resistance applied on the shoulder; and 2) use or non-use of feedback. Once participants reach pain free execution, the program will be progressed into re-education exercises according to the participants' work, sport and activities of daily living and will incorporate activities involving the upper and lower limbs.
15868667|NCT03892603|Other|Education and advice|Each participant will be given written information about the shoulder (anatomy and function), basic pain science and will be directed to the Internet to watch a series of carefully selected educational videos. Comprehensive written advice will include: Information about the shoulder and the condition; Pain neuroscience; Activity modification (when to increase and decrease); Pain management (night and day); A series of educational videos to watch with 2 questions to answer per video: a) what was the most important message? and b) was there anything you didn't understand in the video?
15868668|NCT03892590|Biological|Gut microbiota|Status of microbiota
15868669|NCT03892577|Drug|Precision oncology including targeted therapy and immunotherapy|Therapeutic regimens are based on the clinicopathological features, genomic alterations, advices from multidisciplinary tumor board and willings from patients.
15868670|NCT03892564|Drug|MC2-01 Cream, irradiation|One application of MC2-01 Cream, followed by irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation
15868672|NCT03892564|Drug|MC2-01 vehicle, irradiation|One application of MC2-01 vehicle, followed by irradiation. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation
15868673|NCT03892564|Drug|MC2-01 vehicle, no irradiation|One application of MC2-01 vehicle. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation
15868674|NCT03892564|Drug|Control, irradiation|Untreated, irradiated site. Visual evaluation of application site using a visual scale that rated the degree of erythema, edema and other signs of cutaneous irritation
15868675|NCT03892551|Other|Assessment of symptoms patients presenting when admitted to ED|Questionnaire with a predefined list of 35 symptoms
15868676|NCT03892551|Other|Reason for patient presentation at ED|Exploratory interview assessing reason for patient presentation at ED
15868677|NCT03892551|Other|physicians rating of severity of illness|numeric scale ranging from 0 (perfect condition) to 10 (extremely ill)
15868678|NCT03892551|Diagnostic Test|Assessment of vital signs|Assessment of vital signs (heart rate, blood pressure, body temperature, respiration rate, peripheral capillary haemoglobin oxygen saturation)
15868679|NCT03892551|Other|Clinical Frailty Scale|Assessment of frailty by Clinical Frailty Scale (CFS): assess patients' frailty level from 1, very fit, to 9, terminally ill
15868680|NCT03892551|Other|Impaired mobility on presentation (IMOP)|Assessment of IMOP: defined as being unable to stand unaided or walk without help
15868681|NCT03892551|Other|Assessment of suspected diagnosis and differential diagnoses|Assessment of treating physician's suspected diagnosis and differential diagnoses. Answers will be recorded in free text form.
15868682|NCT03892525|Drug|Selicrelumab|escalated dose in intratumoral injection, every 3 weeks, for 3 cycles
15868683|NCT03892525|Drug|Atezolizumab|1200mg IV every 3 week until progression or relapse for maximum 1 year
15868684|NCT03892512|Drug|Esmolol Hydrochloride|Patients will receive hypotensive anesthesia via I .V infusion with esmolol ( Esmolol Hydrochloride )
15868685|NCT03892512|Drug|Dexmedetomidine|The Patients will receive hypotensive anesthesia via I .V infusion with dexmedetomidine (Percedex )
15868686|NCT03892499|Drug|Olinciguat|Oral Tablet
15868687|NCT03892499|Drug|Itraconazole|Oral Capsule
15868688|NCT03892486|Other|The high PUFA diet group|Assumptions of nutritional intervention: in a randomized manner volunteers will be assigned to one of two groups: a control group which will receive general nutritional recommendations, based on the Polish nutrition pyramid, and the intervention group which will receive nutritional recommendations, based on the Polish nutrition pyramid and will consume at least 4 tablespoons of olive oil or 30 grams of nuts every day for 12 weeks.
15868689|NCT03892473|Other|Community mental health teams (CMHT)|Community mental health teams (CMHTs) delivering evidence-based interventions to people with SMI, inspired by the Flexible Assertive Community Treatment (FACT) service delivery model.
15868690|NCT03892473|Other|Care as usual (CAU)|Care as usual (CAU) usually consisting of inpatient psychiatric care or outpatient care prescribing medication.
15868691|NCT03892460|Device|neuromuscular electrical stimulation|bilateral quadriceps exercise with neuromuscular electrical stimulation
15868692|NCT03892447|Drug|Alprostadil|Alprostadil 0.2~0.3ug/kg.h,iv,1h/d,14d
15868693|NCT03892447|Drug|Sodium Ferulate|Sodium Ferulate 2~6mg/kg.d,iv,14d
15868694|NCT03892447|Drug|Dopamine|Dopamine3～5 ug/kg·min,iv,3 h/d,14d
15868695|NCT03892434|Drug|Intravitreal bevacizumab and dexamethasone implant Injection|Bevacizumab 1.25mg is injected into the vitreous cavity through the pars plana using 30G needle-attached syringe for branch retinal vein occlusion, and Dexamethasone 0.75mg implant is injected using injector.
15868696|NCT03892434|Device|Intravitreal dexamethasone implant|Dexamethasone implant insertion using approved kit
15868697|NCT03892421|Drug|Rituximab|Rituximab 375 mg/m²
15868698|NCT03892421|Drug|Carboplatin|Carboplatin AUC5
15868699|NCT03892421|Drug|Cytarabine Injection|Cytarabine 2000 mg/m² qd 2 days
15868700|NCT03892421|Drug|Dexamethasone|Dexamethasone 40 mg
15868701|NCT03892421|Drug|Filgrastim 0.3 MG/ML|One subcutaneous injection daily for 5 days
15868702|NCT03892408|Device|Optiflow ™|supply of 100 % of oxygen at 70 L / min through Optiflow ™ (Fisher and Paykel Healthcare Limited, Auckland, New Zealand) plus standard oxygen supply through rigid bronchoscope during apnea period.
15868703|NCT03892395|Dietary Supplement|B-vitamin supplementation on bone health|An intervention study to investigate the effect of B-vitamin supplementation for 2-years on bone health
15868704|NCT03892395|Dietary Supplement|Control group; Vitamin D, a daily capsule containing 10 µg/day vitamin D|Vitamin D, a daily capsule containing 10 µg/day vitamin D
15868705|NCT03892382|Device|rTMS|High frequency rTMS to induce the long term potentiation in the left dorsolateral prefrontal cortex.
15868706|NCT03892369|Other|Ethanol|Ethanol administration
15868707|NCT03892343|Diagnostic Test|Cardiac MRI|Cardiac Magnetic Resonance Imaging (Siemens Skyra 3T): will be performed using protocols and techniques already in use in our group. All CMR scan derived parameters will be analysed with the investigator blinded to treatment allocation as in previous studies.
15868708|NCT03892330|Drug|Vincristine|Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.
15868709|NCT03892330|Drug|Oxytetracycline/ Cyclophosphamide|Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.
15868710|NCT03892330|Drug|Liposomal doxorubicin|The dosage of Liposomal doxorubicin is half of doxorubicin dosage in Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.
15868711|NCT03892330|Drug|Doxorubicin|Dosage according to Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.
15868712|NCT03892330|Drug|Pharmorubicin|The dosage of pharmorubicin is 2 times of doxorubicin dosage in Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.
15868713|NCT03892330|Drug|Pirarubicin|The dosage of pirarubicin is equal to doxorubicin dosage in Children Wilms tumor diagnosis and therapy recommendations: Wilms Tumor-2016 (WT-2016) (2-6) Chemotherapy.
15868714|NCT03892317|Behavioral|Pharmacist led medication adherence interventions|Medication adherence interventions which will be tailored to individual patient need
15868715|NCT03892304|Other|Self-report written questionnaire|"Patient questionnaire filled-out in presence of clinical nurse. Gynecological options and contraceptive choices were recorded. Close-ended questions used (yes/no): contraception use; contraceptive pill use; contraceptive implant; intrauterine device; tubal sterilization; mechanical contraception; other type of contraception use; previous term delivery; gynecological follow-up; previous Pap smear. If Yes was noted, more details were requested (contraception name, delivery date, gynecological follow-up frequency, last Pap smear date).
~Other gynecological history and management data not included in the 2014 questionnaire: age at first menstruation, menstrual cycle regularity without hormonal contraception, age at menopause, previous human papilloma virus vaccination, recurrent vulvovaginal candidiasis, urinary incontinence, fertility/infertility data, and infertility treatment with assisted reproductive technologies. Results were compared with those obtained in 2014 (121 women)."
15868716|NCT03892278|Behavioral|Water-based aerobic training|Participants who will be randomized for the intervention in the aerobic training group will carry out exercises with no interval for exercise change. Intensity will be increased every mesocycle and participants will carry out three 3-minute series of each exercise. In the first mesocycle (weeks 1-2) the intensity will correspond to 80-85% of heart rate corresponding to the anaerobic threshold (HRat). In the second mesocycle (weeks 3-4) the intensity will correspond to 85-90% of HRat. In the third mesocycle, the intensity will correspond to 90-95% of HRat from weeks 5-7. In the fourth mesocycle, the intensity will correspond to 95-100% of HRat from weeks 8-10. In the fifth mesocycle (weeks 11-13) the intensity will correspond to the 100-105% of HRat for 2 minutes and <85% of HRat for 1 minute. The last mesocycle (weeks 14-16) the intensity will correspond to the 105-110% of HRat for 2 minutes and <85% of HRat for 1 minute.
15868717|NCT03892278|Behavioral|Water-based aerobic and combined training|Participants who will be randomized for the intervention in the aerobic and combined training group will perform 8 weeks of aerobic training and more 8 weeks of aerobic and resistance training in same session. In aerobic training the participants will perform three 3-min series of each exercise. The intensity will correspond to 80-85% of heart rate of anaerobic threshold (HRat) (weeks 1-2), 85-90% of HRat (weeks 3-4), 90-95% of HRat (weeks 5-7), 95-100% of HRat (weeks 8-10), 100-105% for 2 min and <85% of HRat for 1 min (weeks 11-13) and 105-110% for 2 min and <85% of HRat for 1 min (weeks 14-16). Resistance training will be divide into two blocks of exercises perform each repetition at maximal effort, speed and amplitude. Participants will perform 2 sets of 30 s for each block in the first mesocycle (weeks 9-10), 3 sets of 20 s in the second mesocycle (weeks 11-13) and 4 sets of 15 s in the third mesocycle (weeks 14-16).
15868718|NCT03892278|Behavioral|Control group|The control group will perform a weekly session composed of 30 minutes of therapeutic and playfull exercises in the aquatic environment, involving games, relaxation, massage and conversation.The participants will receive instructions to perform the movements as slowly as possible to avoid physical effort.
15868719|NCT03892265|Other|Observational Study|No intervention is included in this observational study.
15868720|NCT03892252|Other|No intervention|No intervention
15868721|NCT03892239|Behavioral|RunIn3 Prevention Program|"The intervention will be delivered online. Every two weeks we will send a link to participants that will direct them to an online questionnaire. The online questionnaire will collect information on complaints and symptoms related to running, and the volume, intensity and frequency of running practice within the 2-week period. If the participant reports any symptom and if she/he accepts a suggestion regarding running training, an algorithm embedded in the online system will automatically suggest a training volume for the next two weeks based on the distance and/or duration reported by the participant.
~Through a website we will make available informative texts, videos and infographics in order to increase the participant's knowledge regarding topics such as: musculoskeletal symptoms; foot strike patterns; training workload; running shoes; warming-up/cooling-down, stretching; and concomitant strength training."
15868722|NCT03892239|Behavioral|Feedback Based Surveillance|The intervention will be delivered online. Every two weeks we will send a link to participants that will direct them to an online questionnaire. The online questionnaire will collect information on complaints and symptoms related to running, and the volume, intensity and frequency of running practice within the 2-week period. If the participant reports any symptom and if she/he accepts a suggestion regarding running training, an algorithm embedded in the online system will automatically suggest a training volume for the next two weeks based on the distance and/or duration reported by the participant.
15868723|NCT03892213|Drug|Benznidazole|Benznidazole single dose (2.5 mg/kg) at Day 1. Benznidazole single dose (2.5 mg/kg) at Day 9*. Benznidazole multiple dose (2.5 mg/kg twice daily) from Day 12* until Day 15.
15868724|NCT03892213|Drug|E1224|"E1224 multiple dose 400 mg loading dose once daily for 3 days (i.e. from Day 4 to Day 6 followed by maintenance dose 100mg once daily for 9 days (from Day 7 to Day15).
~On Day 9 and from Day 12 to Day 15, E1224 and benznidazole will be given concomitantly."
15868725|NCT03892200|Behavioral|Daily Mouth Care|Nursing assistants will be trained to provide daily mouth care to all residents in nursing homes. Mouth care supplies will also be provided to intervention assisted living communities.
15868726|NCT03892187|Behavioral|Intervention Group|Walking prescriptions plus weekly coaching calls prior to surgery.
15868727|NCT03892174|Other|Treatment protocol with adsorption|Adsorption while patients are in the OR on the extracorporeal circuit
15868728|NCT03892161|Drug|Darunavir/ritonavir 800/100 mg tablet|Standard dose DRV/r administered
15868729|NCT03892161|Drug|Rifampicin 600mg QD tablet and DTG 50mg BD|Rifampicin and DTG added
15868730|NCT03892148|Drug|Furosemide|Protocol for the use of diuretics
15868731|NCT03892148|Drug|Hydrochlorothiazide|Protocol for the use of diuretics
15868732|NCT03892135|Other|Interviews with parents of children with juvenile idiopathic arthritis|Interviews with parents of children with juvenile idiopathic arthritis
15868733|NCT03892135|Other|Interviews with children with juvenile idiopathic arthritis|Interviews with children with juvenile idiopathic arthritis
15868734|NCT03892135|Other|Interviews with Physicians|Interviews with Physicians
15868764|NCT03891875|Combination Product|Subcutaneous elamipretide through the elamipretide delivery system|Subjects will be randomized in a 2:1 ratio to receive either elamipretide or placebo through the elamipretide delivery system. Subjects will dose daily for up to 48 weeks.
15868765|NCT03891875|Combination Product|Subcutaneos placebo through the elamipretide delivery system|Subjects will be randomized in a 2:1 ratio to receive either elamipretide or placebo through the elamipretide delivery system. Subjects will dose daily for up to 48 weeks.
15868735|NCT03892122|Drug|Propofol Fresenius|"Propofol will be infused with TCI (Target Controlled Infusion) pump. TCI system has been developed to provide improved convenience and control during intravenous anaesthesia. The basic principle is that the anesthetist sets and adjusts the target blood concentration- and depth of anesthesia-as required on clinical grounds.
~Infusion rates are altered automatically according to a validated pharmacokinetic model. TCI technology uses different pharmacokinetic modeling to control the infusion rate of the pump, which allows for a direct control of the sedative agent brain concentration rather than its blood concentration. (de vito 2017) The development of target-controlled infusion (TCI) technology has increased the number of indications for propofol sedation in clinical practice. Furthermore, several studies have demonstrated that propofol-based TCI allows for the accurate control of sedation during DISE and results in an authentic reproduction of the sleep process."
15868736|NCT03892122|Drug|Dexmedetomidine|is a selective alpha-2 adrenergic receptor agonist, which seems to act on the locus coeruleus (LC) or to the preoptic hypothalamus to decrease wakefulness, with almost no effect on respiratory depression. Dexmedetomidine exerts its hypnotic action through activation of central pre- and postsyn¬aptic alpha2-receptors in the locus coeruleus, thereby inducting a state of unconsciousness similar to natural sleep, with the unique as¬pect that patients remain easily arousable and cooperative. Comparing with propofol, dexmedetomidine provides a state of sedation closer to natural sleep and lesser upper airways muscular relaxing effect, even at the increased anesthetic dosage Otherwise, Dexmedetomidine is characterized by a slightly longer onset of action (5-10 minutes), and patients take longer timing to recover..The sedative action of Dexmedetomidine can be reached by means of infusion technique (starting dose: 1 μg/kg over 10 minutes; maintenance infusion rate: 0,7 μg/kg/h).
15868737|NCT03892109|Other|No Cord impression material|the no cord self- retracting impression material placed directly in the tray
15868738|NCT03892109|Device|cord|Cords were placed in the gingival sulcus with use of a cord packer, and left in situ for 10 min before making the impression. None of the retraction cords were immersed in any solution or medicaments prior to insertion.
15868739|NCT03892109|Other|Gingitrac|packed into the sulcus
15868740|NCT03892096|Diagnostic Test|Blood-based cell-free cfDNA qPCR assay|Up to 30mL of blood via venipuncture
15868741|NCT03892083|Device|Transcranial direct current stimulation (tDCS)|Transcranial direct current stimulation is a noninvasive technique of neuronal modulation that has been used in different neurological conditions, including children with cerebral palsy.
15868742|NCT03892070|Dietary Supplement|BETA-HYDROXY-BETA-METHYLBUTYRATE (HMB)|1.5 g of HMB will be provided for 12 weeks twice daily
15868743|NCT03892070|Dietary Supplement|Mannitol|1.5 g twice daily for 12 weeks
15868744|NCT03892057|Behavioral|Internet-based Positive Psychological Intervention|"The investigator's culturally-tailored internet-based Positive Psychology Intervention is a non-pharmacotherapy approach aimed at increasing positive emotional experiences by teaching individuals to engage in intentional activities known to increase psychological and emotional well- being, e.g., mindfulness/meditation. The current 5-week Internet-based intervention will be delivered via a secure website which participants will access at home (or in a public setting with Wi-Fi) using an assigned username and password. The on-line program includes didactic material and home practice with participants logging into the website 3-4 times per week for 15 to 20 minute sessions. In addition to weekly on-line instruction, participants are assigned homework as a means of incorporating skills learned into their day-to-day activities."
15868745|NCT03892044|Drug|Duvelisib|Given PO
15868746|NCT03892044|Biological|Nivolumab|Given IV
15868747|NCT03892018|Drug|Oraxol|Oraxol will be supplied as paclitaxel capsules and HM30181AK-US tablets.
15868748|NCT03892005|Procedure|Total Hip Arthroplasty using MOTIVATION HIP Total Hip System|To systemically document the clinical safety and performance of the commercially available MOTIVATION HIP Total Hip System in primary THA.
15868749|NCT03891979|Drug|Pembrolizumab|"Pembrolizumab will be given for two doses every 3 weeks starting on day 8 (ie days 8 and 29). Antibiotics will continue throughout the entire four week pre-operative period.
~Ciprofloxacin 500mg PO BID days 1-29; Metronidazole 500mg PO TID days 1-29; Pembrolizumab 200mg IV days 8 and 29."
15868750|NCT03891979|Drug|Ciprofloxacin 500mg PO BID days 1-29|Antibiotics will continue throughout the entire four week pre-operative period.
15868751|NCT03891979|Drug|Metronidazole 500mg PO TID days 1-29|Antibiotics will continue throughout the entire four week pre-operative period.
15868752|NCT03891966|Procedure|Rigid Splint|50 patients undergoing operative fixation of isolated bothbone forearm, radial head, olecranon, distal humerus, or humeral shaft fractures will either receive a splint.
15868753|NCT03891966|Procedure|Soft Dressing|50 patients undergoing operative fixation of isolated both bone forearm, radial head, olecranon, distal humerus, or humeral shaft fractures will either receive a soft dressing post-operatively.
15868754|NCT03891953|Drug|DKY709|Novel immunomodulatory agent
15868755|NCT03891953|Drug|PDR001|PDR001 is a high-affinity, ligand-blocking, humanized IgG4 monoclonal antibody directed against PD-1 that blocks the binding of PD-L1 and PD-L2
15868756|NCT03891940|Procedure|patients recieving anterior cervical spine surgery|Anterior cervical discectomy with fusion, or ACDF, is a surgery designed to relieve spinal cord or nerve root pressure in the neck by removing all or part of a damaged disc
15868757|NCT03891927|Dietary Supplement|extra virgin olive oil|During the experimental period (3 months ), participants will be requested to consume daily dose of 30 mL (3 tablespoons) of HP-EVOO
15868758|NCT03891914|Drug|Positron Emission Tomography using 18F-FCH|Positron Emission Tomography imaging coupled with scanner (PET-CT). with the injection of a radiopharmaceutical drug, the 18F-FCH(or fluorocholine) for the detection of bone lesions
15868759|NCT03891914|Drug|Positron Emission Tomography using 18F-FDG|Positron Emission Tomography imaging coupled with scanner (PET-CT). with the injection of a radiopharmaceutical drug, the 18F-FDG (or fluorodeoxyglucose) for the detection of bone lesions
15868760|NCT03891901|Drug|Imatinib|Tablets, administered orally
15868761|NCT03891901|Drug|Isoniazid|300 mg tablets, administered orally
15868762|NCT03891901|Drug|Rifabutin|300 mg capsules, administered orally
15868763|NCT03891888|Procedure|Intramedullary Bone Graft|Patients in this group will undergo standard treatment for their open tibia shaft fracture (irrigation and debridement of their open fracture and reamed intramedullary nailing), but will also have the reamings from the medullary canal preparation collected and packed into the exposed fracture cortex
15868768|NCT03891849|Drug|Octreotide Injection|Patients admitted in intensive care unit after variceal hemorrhage treated with norepinephrine perfusion will received an additional octreotide perfusion during one hour.
15868769|NCT03891823|Device|MitraClip|Study participants will be randomized to MitraClip device to determine treatment efficacy in improving LV remodelling or functional capacity.
15868770|NCT03891823|Drug|Medical Therapy|Study participants will be randomized to medical therapy to determine treatment efficacy in improving LV remodelling or functional capacity.
15868771|NCT03891810|Behavioral|Calm|"The intervention ran for 8-wks with a 4-wk follow-up period. Intervention participants completed 7 days of Calm during Week 1. For the remaining weeks (Week 2- Week 8) intervention participants were asked to meditate during the weekday from a 10-minute meditation of their choice. Throughout the intervention, the Calm College group were sent reminder texts/emails via Google Voice to participate in the meditation sessions if participants are not meditating for more than 30 minutes a week (see Participant Scripts)."
15868772|NCT03891797|Other|Cognitive Processing Therapy|Group-based psychotherapy.
15868773|NCT03891784|Drug|Abemaciclib|Given PO
15868774|NCT03891771|Device|Telemonitoring sensors|This complex platform entails several sensors aimed at detecting falls, nocturia and environmental variables in the participant's home. Sensors are non-intrusive and its only wearable component is the panic button which must be carried by the participant.
15868775|NCT03891758|Biological|DPT-IPV-Hib|0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
15868776|NCT03891758|Biological|Hib vaccine|0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
15868777|NCT03891758|Biological|DPT-IPV|0.5mL, subcutaneous injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
15868778|NCT03891732|Diagnostic Test|MRI prostate|plain biparametric MRI prostate
15868779|NCT03891719|Procedure|Unilateral cleft lip rhinoplasty|"Perform marking with methylene blue tattoo marks
~Inject Local anesthetic solution with epinephrine
~Harvest auricular cartilage
~Make the incisions parallel the lip scar, extende into the marginal incision and encompass any alar webbing. The incisions outline the entirety of the lower lateral cartilage and create sliding chondrocutaneous flap. This flap combines with reverse U incision.
~Harvest septal bony cartilaginous unit for grafting the caudal septum and suspend the medial crural cartilages
~Create dome symmetry at the cartilage level and reconstruct nasal tip with other grafts (shield-type tip graft, cap graft, alar batten graft)
~Dorsal augmentation
~Lip reconstruction and alar base repositioning.
~Closure and repair vestibular deficiency with the reverse-U component of the chondrocutaneous flap at the alar rim."
15868784|NCT03891693|Device|Passeo-18 Lux and SUPERA® stent|Angioplasty of Arteriovenous Fistula (AVF) performed using Passeo-18 Lux and SUPERA® stent for patients with cephalic arch stenosis
15868785|NCT03891680|Drug|Botox Injectable Product|Intra articular Botox injection
15868786|NCT03891680|Device|Radiofrequancy|Genicular nerves radiofrequancy
15868787|NCT03891667|Drug|Disulfiram|Patients will receive disulfiram for 4 weeks followed by placebo for 4 weeks or disulfiram for 8 weeks.
15868788|NCT03891654|Diagnostic Test|Dynamic Contrast Enhanced Computed Tomography|Patients will receive DCE-CT prior to the start of standard of care, Stereotactic Body Radiation Therapy (SBRT), as well as 6 hours post administration of SBRT and 6 weeks post administration of SBRT.
15868789|NCT03891641|Behavioral|Treadwell Tredlr|Complete treadling exercise 3x per week (15 min sessions) for 6 weeks.
15868790|NCT03891628|Behavioral|Modified Attachment and Biobehavioral Catch-up|Intervention targets include enhancing nurturance and following the child's lead, as well as supporting use of kangaroo care, swaddling, and breastfeeding.
15868791|NCT03891628|Behavioral|Modified Developmental Education for Families|Intervention targets include supporting developmental monitoring and parental engagement in activities that promote cognitive and motor development.
15868792|NCT03891615|Drug|Niraparib|"Niraparib is a type of drug called a PARP inhibitor, which blocks DNA (the genetic material of cells) damage from being repaired or may prevent damage from occurring in the first place. In cancer treatment, inhibiting PARP may help kill cancer cells through deadly DNA damage."
15868793|NCT03891615|Drug|Osimertinib|Osimertinib blocks mutated EGFR, which may cause tumor regression (when the tumor starts to shrink) and prevent the spread of the cancer.
15868794|NCT03891602|Behavioral|Cataldo Lung Cancer Stigma Scale (Smoking-Related Subscale)|Perceived Smoking-Related Stigma will be measured using the 5-item Cataldo Lung Cancer Stigma Scale (Smoking-Related Subscale). The response scale is 1 = strongly disagree, to 4 = strongly agree, and scores range from 5 to 25 (high stigma). Cronbach's alphas were 0.75 to 0.89 in prior studies.
15868795|NCT03891602|Behavioral|Patient Trust in the Medical|"Medical Mistrust will be measured using the 5-item Patient Trust in the Medical Profession Scale.80 The five-point Likert responses measure the extent to which patients perceive their clinician to be honest, caring more about convenience, thorough and careful, and trusted. The range of scores is 5 to 25 (higher mistrust). Reliability and validity have been well established with a Cronbachs alpha of 0.84."
15868796|NCT03891602|Behavioral|Decision Conflict Scale - Lung Cancer Screening|"The DCS is a 16-item Likert-response item scale that has been modified for the lung cancer screening and smoking cessation contexts. The DCS was developed by OConnor,74-75 and validated in many health decisions including breast cancer screening with Cronbachs alphas ranging from 0.78 to 0.81. 74-75 Despite its name, the DCS measures more than decision conflict to encompass personal perceptions of perceived decision-making quality such as feeling the choice is informed, values based, and likely to be implemented as well as expressing satisfaction with the decision. 74-75 The DCS is comprised of items with response options ranging from 1 (strongly disagree) to 5 (strongly agree). The items are summed to total scale score with lower scores reflective of higher decision conflict and higher scores reflective of lower decision conflict."
15868797|NCT03891602|Behavioral|Shared Decision Making Questionnaire - Patient|"Shared Decision Making Process will be measured from the patient perspective using the 9-item Shared Decision Making Questionnaire (SDM-Q-9),77 which has been validated with a Cronbachs alpha of 0.94."
15868798|NCT03891602|Behavioral|Stage of Readiness for Smoking Cessation - Contemplation Ladder|Among current smokers
15868799|NCT03891602|Behavioral|Primary Care Clinicians' Lung Cancer Screening Survey|Includes items to assess attitudes, barriers, and knowledge of lung cancer screening guidelines.
15868800|NCT03891589|Behavioral|Nutritional education program|These programs were a process of providing information or knowledge to mother of the children consisting of information on initiation of complementary feeding, variety, and frequency of food, nutrient requirements and diet pattern for children (the amount and types of food), and benefits of Taburia. All this information provided through class-based activities and group discussion by using leaflet and food model conducted by the researchers. Education materials developed based on CFR models from our previous study by applying the LP approach. There was also a demonstration on administering complementary feeding (demo and cooking class) to improve skills of the mother on food from selection, design, handling and preparing, based on requirements of the children. This activity conducted through training once per month for the first four months of the intervention. Components of complementary feeding promoted in this study are based on CFR using LP approach from our previous research.
15868801|NCT03891589|Dietary Supplement|Home fortification (Taburia)|Taburia is a multivitamin and mineral fortification to provide sufficient amount of nutrient for optimal growth and development of children aged 6-59 months. Every sachet of Taburia prepared to fulfill minimum nutrient requirements for children aged 6-59 months. Each sachet is one gram in weight and contains vitamin A (417 mcg), B1 (0.5 mg), B2 (0.5 mg), B3 (5.0 mg), B6 (0.5 mg), B12 (1 mcg), D3 (5 mcg), E (6 mg), K (20 mcg), C (30 mcg), folic acid (150 mcg), pantothenic acid (3 mcg), Iodium (50 mcg), Iron (10 mg), Zn (5 mg) and Selenium (20 mcg). One sachet of Taburia given to the subject by adding it to their breakfast and must be finished. The frequency of Taburia consumption per week follows the finding of the LP analysis from the previous study. Taburia intervention complemented by health education related to benefits, administration of Taburia, and its side effects. Compliance will be evaluated directly by the researcher based on empty Taburia sachet and conducted every month.
15868802|NCT03891576|Drug|Niraparib|Niraparib is a potent, orally active PARP1 and PARP2 inhibitor being developed as a treatment for patients with tumors that harbor defects in the homologous recombination DNA repair pathway or that are driven by PARP-mediated transcription factors.
15868803|NCT03891550|Drug|Epclusa|sofosbuvir (SOF) 400 mg/Velpatasvir(VEL) 100 mg fixed-dosage combination once-daily for 12 weeks for all HCV genotype patients with and without hepatic decompensation
15868804|NCT03891524|Drug|JNJ-70033093 25 mg|Participants will receive JNJ-70033093 25 mg (1*25 mg capsule) BID (in Group A) or once daily (in Group E), orally for 10 to 14 postoperative days.
15868805|NCT03891524|Drug|JNJ-70033093 50 mg|Participants will receive JNJ-70033093 50 mg (2*25 mg capsules) BID orally for 10 to 14 postoperative days.
15868806|NCT03891524|Drug|JNJ-70033093 100 mg|Participants will receive JNJ-70033093 100 mg (1*100 mg capsule) BID, orally for 10 to 14 postoperative days.
15868807|NCT03891524|Drug|JNJ-70033093 200 mg|Participants will receive JNJ-70033093 200 mg (2*100 mg capsules) BID (in Group D) or once daily (in Group F), orally for 10 to 14 postoperative days.
15868808|NCT03891524|Drug|Placebo|Participants will receive placebo matching to JNJ-70033093, orally.
15868809|NCT03891524|Drug|Enoxaparin 40 mg|Participants will receive enoxaparin 40 mg once daily subcutaneously for 10 to 14 postoperative days.
15868810|NCT03891511|Device|MRI scann|MRI will be performed in the TMJ of participants affected with TMD
15868811|NCT03891498|Drug|MgSO4|The magnesium sulfate will be given according to the regimen of 6 grams intravenous over 20 minutes as a loading dose.
15868812|NCT03891485|Biological|Immunological and tumour characterization|FFPE, blood samples (liquid biopsy, heparin and EDTA blood) performed in patients presenting a renal metastatic cancer receiving treatment as standard practice according to physician's choice (2nd or 3rd line of treatment with nivolumab, or other second line according to physician's choice)
15868813|NCT03891472|Drug|Patients will receive initial chemotherapy, followed by evaluation of the response to the treatment, followed by SBRT, followed by chemotherapy.|mFOLFIRINOX > SBRT > mFOLFIRINOX > Surgical Intervention
15868814|NCT03891459|Behavioral|spray+ manipulation|Participants in spray+ group received placebo manipulation and were told they sprayed was oxytocin (in fact, it was saline);
15868815|NCT03891459|Behavioral|control manipulation|Participants in control group were told they sprayed saline (in fact, it was saline).
15868816|NCT03891446|Drug|Bimatoprost SR|Patients from Stage 2 of lead-in study 093 are eligible to receive up to 2 additional Bimatoprost SR administrations of the 10 mcg dose in the study eye through completion of Month 12 visit Patients from lead-in studies 091, 092 and 095 will not receive additional Bimatoprost SR administrations in the study eye Fellow eye of all patients will receive only standard of case based on investigator judgment.
15868817|NCT03891433|Drug|Meropenem|Carbapenems group intervention.
15868818|NCT03891433|Drug|Ertapenem 1000 MG|Carbapenems group intervention.
15868819|NCT03891433|Drug|Piperacillin, Tazobactam 4-0.5G Solution for Injection|Piperacillin/Tazobactam group intervention.
15868820|NCT03891420|Drug|Galidesivir|Galidesivir IV infusion
15868821|NCT03891420|Drug|Placebo|Placebo IV infusion
15868822|NCT03891407|Diagnostic Test|Self-Testing Education and Promotion|Camp members will receive the Self-Testing Education and Promotion (STEP locally referred to as Mate Yako Afya Yako) intervention and will receive HIV-counseling and oral HIV self-testing kits.
15868823|NCT03891394|Diagnostic Test|Human epididymis protein 4|Human epididymis protein 4 serum level in predicting persistent proteniuria
15868824|NCT03891381|Device|Tetragraph quantitative monitoring|Neuromuscular monitoring will be guided by information provided by the Tetragraph
15868860|NCT03891082|Procedure|B-Lynch|A 70 mm round bodied hand needle on which a No. 2 absorbable suture is mounted is used to puncture the uterus 3 cm from the right lower edge of the uterine incision and 3 cm from the right lateral border. The mounted No. 2 absorbable suture is threaded through the uterine cavity to emerge at the upper incision margin 3 cm above and approximately 4 cm from the lateral border
15869044|NCT03889405|Device|TOCO|Some of the study participants will undergo continuous recording of the uterine contractions and the fetal heart rate (FHR) by TOCO as well.
15868827|NCT03891355|Drug|Carfilzomib|Carfilzomib
15868828|NCT03891355|Drug|Lenalidomide|Lenalidomide
15868829|NCT03891355|Drug|Dexamethasone|Dexamethasone
15868830|NCT03891342|Drug|Fluid bolus administration|"Fluid bolus administration either fast in 5 minutes or slow in 30minutes."
15868831|NCT03891329|Device|Acticor/Rivacor ICDs/CRT-Ds|pre-defined device programming, measurements and follow-up schedule
15868832|NCT03891329|Device|Plexa S DX|Implantation, measurements and follow-up schedule
15868833|NCT03891316|Diagnostic Test|HFIP and Sevoflurane are measured after 3 consecutive days of work.|Concentration of hexafluoroisopropanol and Sevoflurane are measured in urine by gas chromatography
15868834|NCT03891303|Other|Allogenic blood transfusion (ABT)|During elective open aortic surgery, the autologous blood from ICS was processed and re-transfused in all patients. However, TR group additionally received ABT.
15868835|NCT03891290|Other|Collecting recorded videos of Colonoscopy screening tests of the general population|To evaluate, in objective way, the usability of the future alpha version of the APDS device by testing the sensitivity and specificity of its results achieved from running it on the collected recorded videos of Colonoscopy screening tests of the general population.
15868836|NCT03891277|Drug|Ferrous succinate|"Ferrous succinate sustained-release tablets（Ferrous succinate 0.2g）1 tablet, Qd,po during or after breakfast, Lasting for 12 weeks.
~placebo with almost the same size, color and smell as Ferrous iron will be used with 1 tablet, Qd, po during or after breakfast, Lasting for 12 weeks."
15868837|NCT03891264|Drug|Cannabidiol|Epidiolex, an agent within the anti-epileptic drug class, will be used. Epidiolex, Greenwich Biosciences Inc.'s CBD formulation, is a 100 mg/mL purified oral solution. The recommended starting dosage is 2.5mg/kg taken twice daily (5mg/kg/day). After one week, the dosage will be increased to a maintenance dosage of 10 mg/kg twice daily (20 mg/kg/day). At the end of the first week, the patient will increase the dose to 10 mg/kg twice daily for the following week.
15868838|NCT03891251|Other|Collecting recorded videos of Colonoscopy screening tests|To evaluate, in objective way, the usability of the future alpha version of the APDS device by testing the sensitivity and specificity of its results achieved from running it on the collected recorded videos of Colonoscopy screening tests of the general population.
15868839|NCT03891238|Drug|Avelumab|Patients will receive avelumab at standard dosage of 10 mg/kg as a 1-hour intravenous infusion once every 2 weeks (Q2W).
15868840|NCT03891225|Procedure|Amniotic Membrane implantation|Surgical procedure will be performed with Longemire Traverso technique. At the end of all pancreatic, biliary and duodenal anastomosis, the AM will be implanted.
15868841|NCT03891212|Behavioral|Placed in prone position for at least 16 consecutive hours a day.|Patients assigned to the prone group had to be turned within the first hour following randomization. They were placed in prone position for at least 16 consecutive hours. Patients assigned to the control group had to be turned within the first hour following randomization. They were placed in supine position for at least 16 consecutive hours.
15868842|NCT03891199|Procedure|Robotic-Arm Assisted THA|The study will examine the acetabular cup placement of THA patients and compare results for patients who undergo THA with robotic-arm assistance with those who undergo traditional THA.
15868843|NCT03891186|Behavioral|Metacognitive Training in Schizophrenia (MCT)|"MCT is a group program with eight modules referring to common cognitive and biases in solving problems in schizophrenia. The following topics of MCT are: attribution blaming and taking credit (module 1), jumping to conclusions (modules 2 and 7), changing beliefs (module 3), deficits in theory of mind and social cognition (modules 4 and 6), overconfidence in (memory) errors (module 5) and depression and low self-esteem (module 8). Each session lasts 45 to 60 minutes and follows a protocol defined in the manual Metacognitive Training for Psychosis (MCT) that is currently available in 35 languages (available in www.uke.de/mkt)."
15868844|NCT03891186|Other|Treatment As Usual (TAU)|In both groups will be maintained the TAU.
15868845|NCT03891173|Drug|L-DOS47|L-DOS47 lyophilized powder reconstituted and diluted for iv injection
15868846|NCT03891173|Drug|Cisplatin|Cisplatin concentrate for solution for iv infusion
15868847|NCT03891173|Drug|Vinorelbine|Vinorelbine concentrate for solution for iv infusion
15868848|NCT03891160|Other|3D model of heart|To assess if a 3D printed cardiac model improves visualization of VAD and cannula placement sites in CHD-HF patients as compared to 2D imaging. The investigators will prospectively enroll CHD-HF patients at multiple centers and randomize to group A (3D printed models will be used for pre-VAD planning) or Group B (controls).
15868849|NCT03891147|Other|Electro-acupuncture|
15868850|NCT03891134|Dietary Supplement|Branched Chain Amino Acid|Participants were purposively sampled to receive one sachet enriched BCAA twice a day(7.2g) for 5 weeks.
15868851|NCT03891121|Device|Occlusal Splint|Occlusal splints are appliances that were usually applied to the upper jaw and covering all teeth and they are made of autopolymerizing acrylic resin. It is produced by using 2 mm thick hard acrylic between the maxilla and mandible as defined by the Okeson.
15868852|NCT03891121|Drug|Botulinum toxin type A|We diluted 100-U freeze-dried BTX-A with 1.0 milliliters of sodium chloride, resulting in a dose of 1.0 U per 0.1 mL. We administered all skin injections by using a 1-inch 30-gauge needle. Patients were placed with the Frankfurt horizontal plane parallel to the floor.
15868853|NCT03891108|Drug|BMS-986231 Formulation A|Participants will be administered BMS-986231 Formulation A as IV infusion for 48 hours.
15868854|NCT03891108|Drug|BMS-986231 Formulation B|Participants will be administered BMS-986231 Formulation B as IV infusion for 48 hours.
15868861|NCT03891082|Procedure|BALLOON INSERTION|Insert the balloon portion of the catheter in the uterus; making certain that the entire balloon is inserted past the cervical canal and internal ostium. NOTE: Avoid excessive force when inserting the balloon into the uterus. Place a Foley catheter in patient bladder to collect and monitor urine output. To ensure maintenance of correct placement and maximize tamponade effect, the vaginal canal may be packed with iodine or antibiotic soaked vaginal gauze at this time.
15868862|NCT03891069|Device|AHA Exergame System|The AHA Exergame System consists of a mobile computing platform running a set of parameterizable exergames purposely designed for elderly fitness training. The platform is equipped with a 1000 lumens video projector capable of creating a 2.05m by 1.16m floor projection display and a Kinect V2 sensor to serve as game controller. The AHA exercise-based computer games have been designed for and tested with elderly people and were adapted for the functional limitations of PD patients. The system includes five different games that aim to train patients motor ability, cardiorespiratory and muscular strength.
15868863|NCT03891056|Procedure|metabolic surgery|The study will randomize patients into two arms, one where a laparoscopic gastric bypass will be performed and another that will perform slevee gastrectomy.
15868864|NCT03891043|Dietary Supplement|Selenium|A 100 micrograms of Selenium was given to be taken twice a day.
15868865|NCT03891043|Other|Placebo|Placebo pill of 100 micrograms of starch was given to be taken twice a day.
15868866|NCT03891030|Other|Checklist Based Box system intervention|The intervention has both behavioural change and service utilization drop out tracing mechanism. Special type of boxes designed to schedule health educations and continued service utilization monitoring boxes will be placed at health posts and health centers respectively. Community level survey will be conducted to identify suspected pregnant mothers using stanback et al, 1999 checklist, and mothers are linked to health centers. Then, they will be followed for their subsequent attendance of consecutive maternal health services (ANC 2nd-third PNC). Mothers who fail to utilize the service will be traced; will get person-centered health education to continue the service.
15868867|NCT03891017|Other|vacuum casting|Participants will be cast using vacuum casting (Ottobock Harmony) method. The method of casting will be randomized via RNG. Participants will be fitted with both sockets and dynamic alignment procedures will be performed. This 15-minute fitting and alignment period will address any extreme gait deviations and initial socket discomforts. After fitting, the participant will then be given a 15-minute adjustment period to wear the device. We will then begin the assessment phase, beginning with the timed Get-Up and Go test and followed by the 6-Minute Walk test. Each patient will perform 3 rounds of each test and patient order will be determined at random. The participants will be given a 10 min break between each series of tests. At the end, a questionnaire will be given.
15868868|NCT03891017|Other|hydrostatic casting|Participants will be cast using aqua casting method. The method of casting will be randomized via RNG. Participants will be fitted with both sockets and dynamic alignment procedures will be performed. This 15-minute fitting and alignment period will address any extreme gait deviations and initial socket discomforts. After fitting, the participant will then be given a 15-minute adjustment period to wear the device. We will then begin the assessment phase, beginning with the timed Get-Up and Go test and followed by the 6-Minute Walk test. Each patient will perform 3 rounds of each test and patient order will be determined at random. The participants will be given a 10 min break between each series of tests. At the end, a questionnaire will be given.
15868869|NCT03891004|Procedure|Subcuticular Skin Closure|We will only close the subcuticular layer with suture
15868870|NCT03891004|Device|Tissue Adhesives|No subcuticular closure will be done. Only tissue adhesives applied to the approximated skin
15868871|NCT03890991|Behavioral|SCOPE-DM|The 12-week programme aims to support motivation and enable capability for managing diabetes. To this end, the sessions will integrate the knowledge and practical skills components offered in traditional diabetes education with psychological techniques and principles for behavioural change: problem solving, goal-setting and monitoring. The programme offers the potential for older people to learn about their condition and treatment in a psychologically-motivating and confidence-enhancing structure - as such the emphasis is on empowering individuals to make choices and lifestyle changes in line with treatment recommendations through the use of problem solving, goal setting and feedback, and not just on knowledge transfer which has not been shown to be successful in behavioural change. The content and delivery format will largely be informed by motivational interviewing
15868872|NCT03890991|Behavioral|SCOPE-DM with 3 months' supply of glucometer|Participants in this arm will participate in the SCOPE-DM programme and use the glucometer for 3 months.
15868873|NCT03890991|Behavioral|SCOPE-DM with 6 months' supply of glucometer|Participants in this arm will participate the in SCOPE-DM programme and use the glucometer for 6 months.
15868874|NCT03890978|Other|promotional Exclusive breastfeeding text messages|promotional Exclusive breastfeeding text messages will be send to women via mobile phone
15868875|NCT03890965|Other|Reflex locomoction therapy|"The intervention of the stimulation of the reflex locomotion is carried out in this study in a sitting position in a conventional chair, an unorthodox posture in the usual treatment of Vojta therapy.
~The reflex stimulation is performed by the passive pressure exerted by the weight of the wrist (pisiform) on the rubber sphere. Simultaneously the patient has to exert a slight pressure with the heel towards the ground with his foot. This foot will be the opposite of the wrist that has the sphere under the pisiform.
~Alternating each diagonal 4 times, 5 minutes each. Total session 20 minutes, 2 times x day, every day according to degree of affectation."
15868876|NCT03890952|Drug|Nivolumab|Treatment with the combination of Nivolumab and bevacizumab every 2 weeks
15868877|NCT03890952|Drug|Bevacizumab|Treatment with the combination of Nivolumab and bevacizumab every 2 weeks
15868878|NCT03890939|Device|BiPAP AutoSV Advanced System One|A mode of positive airway pressure used to treat sleep apnea. The difference between this device and the other experimental device is in the algorithm of the pressure settings.
15868879|NCT03890939|Device|Dreamstation BiPaP AutoSV|A mode of positive airway pressure used to treat sleep apnea. The difference between this device and the other experimental device is in the algorithm of the pressure settings.
15868880|NCT03890939|Device|ResMed S7 VPAP Adapt Device|A mode of positive airway pressure used to treat sleep apnea. This device is widely used by physicians to treat sleep apnea and will be the active comparator to the two experimental devices.
15869045|NCT03889392|Procedure|Kidney transplantation and nephrectomy|Bilateral nephrectomy of polycystic kidneys are routinely performed during kidney transplantation in ADPKD patients
15868881|NCT03890926|Radiation|radioactive Iodine-125 seed implantation under the guidance of 3D template|3D-PNCT assisted with CT-guidance for radioactive Iodine-125 seed brachytherapy is a conventional treatment for patients with local recurrent rectal carcinoma. Retrospective data on the effectiveness and adverse effects of the past radioactive Iodine-125 seed implantation is collected.
15868882|NCT03890900|Other|T2DXcel mobile application|T2DXcel is a mobile application (patient-facing) that delivers guideline-based diabetes education.
15868883|NCT03890887|Drug|BI 1291583|Tablet
15868884|NCT03890887|Drug|Itraconazole|Oral solution
15868885|NCT03890861|Behavioral|Physical activity|Promotion of physical activity to the current federal physical activity guidelines.
15868886|NCT03890861|Behavioral|Successful Aging|Seminars of health topics related to aging in African Americans with light stretching and low intensity activites
15868887|NCT03890848|Behavioral|Wechat application reminder intervention|precautions and rehabilitation progress reminders and other news by optimized WeChat applet regularly
15868888|NCT03890848|Behavioral|routine guidance during discharge|rehabilitation exercise guidance during routine discharge
15868889|NCT03890835|Procedure|MTA Pulpotomy.|Pulpotomy using MTA.
15868890|NCT03890835|Procedure|Biodentine Pulpotomy|Pulpotomy using Biodentine
15868891|NCT03890809|Drug|BMS-986165|Oral administration
15868892|NCT03890796|Behavioral|Activity Scheduling|AS is strategy for behavioral activation that has also been used with success in people with dementia, after the training of their caregivers. A certified occupational therapist will train up the caregivers of dementia in conducting AS activities for participants in experimental group
15868893|NCT03890796|Behavioral|Educational|A serial of dementia care education program with a weekly theme of topics like: importance of exercise and healthy eating, sleep management, counselling, acceptance therapy, commitment therapy, reminiscence therapy.
15868894|NCT03890783|Other|Evaluation of phonation quality|"Evaluation of phonation quality by :
~Self-evaluation: completion of the Voice Handicap Index questionnaire, in its 30 items version
~Hetero-evaluation: reading and recording of 2 texts, and notation by 3 practitioners using the grade, rough, breathy, asthenic, strained (GRBAS) scale, to evaluate the occurrence and the gravity of rhinolalia"
15868895|NCT03890783|Other|Evaluation of swallowing quality|"Evaluation of swallowing quality by:
~Self-evaluation: completion of the Deglutition Handicap Index questionnaire
~Hetero-evaluation: nasofibroscopy to evaluate the occurrence of aspiration and nasal regurgitation"
15868896|NCT03890783|Other|global quality of life questionnaire|Completion of the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ - C30) and the EORTC QLQ - H&N35 questionnaires
15868897|NCT03890770|Drug|BMS-986165|Oral administration
15868898|NCT03890757|Other|ultrasound guided paravertebral or serratus anterior block|"Patients groups will be as follow:
~Group (I): Serratus plane block will be performed with the patient in the lateral position and the arm abducted. Using a high-frequency linear ultrasound probe ,Group (II): thoracic paravertebral block will be performed in the sitting position. The spinal level chosen for needle insertion will be two segments below the upper most fractured rib or midway between the upper most and lowest fractured rib, 2-2.5 cm distance from the midline in the same injury site"
15868901|NCT03890718|Procedure|Simultaneous Lenticule Impanation (SLI)|Increase cornea stromal thickness in patients with advance ectasia by donor lenticule created during small incision lenticule extraction (SMILE)
15868902|NCT03890692|Procedure|flexible nasoendoscopy|"nasopharyngeal endoscopy : After washing nasal cavities with a sterile physiologic solution to remove secretions or scabs, and decongesting them with an oxymetazoline solution in the subjects with turbinate hypertrophy,
~Endoscopy will be performed by passing the endoscope along either the floor of the nose or just under the middle turbinate. the condition of the nasal mucosa\ septum\ turbinates and the presence of discharge The postnasal space will be assessed . All abnormalities will be recorded .the images will be recorded and assessed separately by two independent otolaryngologists"
15868903|NCT03890679|Diagnostic Test|rapid whole genomic sequencing (rWGS)|rWGS and NewbornDx are genomic sequencing platforms
15868904|NCT03890666|Drug|Albuterol eMDPI DS|"Albuterol sulfate electronic multidose dry powder inhaler (Albuterol eMDPI) Digital System (DS) with 4 component devices:
~Device 1: Albuterol eMDPI
~Device 2: Albuterol eMDPI Patient-facing smart device application (App)
~Device 3: Digital Health Platform (DHP, Cloud solution)
~Device 4: Provider-facing dashboard (dashboard)"
15868905|NCT03890666|Drug|albuterol|Standard of care albuterol-administering rescue inhaler
15868906|NCT03890653|Behavioral|Performance-Based Financing|Incentive-based payments
15868907|NCT03890653|Behavioral|Decentralized Facility Financing|Financing not linked to service delivery.
15868908|NCT03890640|Procedure|Ultrasound-guided TECI|When performing an ultrasound-guided thoracic epidural catheter insertion (TECI), an 18-gauge Tuohy needle will be used for interlaminar epidural access. All procedures will be performed with a paramedian approach under ultrasound-guidance and using the loss of resistance technique with saline. If the needle is deemed to be in the epidural space when the loss of resistance occurred, fluoroscopic views will be obtained to confirm which the catheter tip is located in the epidural space or not.
15868909|NCT03890627|Device|Thoracic bio-reactance|Cardiac output variation measured by thoracic bio-reactance, between inclusion and one year after hemodynamic evaluation by right cardiac catheterization, to discriminate stable patients from those that degrade.
15868993|NCT03889886|Drug|SDP-4 Ophthalmic Solution (3.0%)|Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
15869349|NCT03886883|Other|Rest|The participants rested in a seated position for 10 minutes
15868911|NCT03890601|Biological|blood sample|"A single 15 mL blood draw is planned for this study, as follow:
~10 mL citrated tube (2 tubes) for APTT, PT, D-Dimers, LA, aCL, aβ2GP1, aβ2GP1-dm1 and TGA
~5 mL EDTA tube for blood count
~During a follow up visit, a 5 ml citrated tube and a 5 mL EDTA tube are collected from each patient for their routine laboratory evaluation. One additional citrated tube will be required to measure thrombin generation and aβ2GP1-dm1."
15868912|NCT03890588|Other|CKD enhanced clinical decision support|The CKD-CDS intervention provides clinical recommendations at any primary care visit for patients with a deficit in any of 5 key elements of CKD care.
15868913|NCT03890575|Procedure|Airway stent implantation|The airway stents modified with 3D printing were implanted to treat malignant stricture involving carina and bronchi distal to carina.
15868914|NCT03890562|Other|Auricular acupressure|Auricular acupressure will be applied to five specific acupressure points using a stainless-steel acupressure probe. The five auricular points are: (1) Shen Men, 2) Sympathetic, (3) Kidney, (4) Lung, and (5) Liver. (Tyme, 2001). These sites have been identified by the National Acupuncture Detoxification Association and used for the treatment of withdrawal in adults.
15868915|NCT03890549|Diagnostic Test|SnoreLab (smart phone application for snoring recording)|The investigators selected 3 appropriate downloadable smart phone applications for snoring recording and make validation with the golden standard of polysomnography.
15868916|NCT03890523|Procedure|Airway stent implantation|The segmented airway stent modified with 3D printing were implanted to treat gastro-respiratory fistula involving carina and distal bronchi. The stents were removed because of stent-related complications or tracheobronchial healing.
15868917|NCT03890510|Other|Ringer's Lactate solution|Patients in both groups will receive Ringer's lactate solution continuously during operation with different infusion volume.
15868918|NCT03890510|Procedure|Spine surgery under general Anesthesia in the prone position|The surgery, general anesthesia, and the placement of the prone position will be performed according to the standard procedures.
15868919|NCT03890497|Biological|IPV|The inactivated poliovirus vaccine (IPV) developed by Salk was the first available polio vaccine licensed in 1955 in the United States. The current formulation of IPV got licensed in 1987 and has a higher potency than the original Salk IPV. Almost 100% of children two months of age or older who receive 2-3 doses of intramuscular (IM) IPV achieve high antibody levels against the all three serotypes. IPV (.5mL) can be administered subcutaneously (SC) or IM and fractional (0.1 ml) doses of IPV are generally administered intradermally
15868920|NCT03890484|Behavioral|Peer Type|The type of peers (close friends or new peers) will be manipulated between arms.
15868921|NCT03890471|Behavioral|Preoperative telephone call three days before surgery|Patients will receive a provider-initiated telephone call three days before surgery. In order to standardize counseling across providers, each provider will use a telephone script addressing the following components: Purpose of the surgery, alternatives to the surgery, surgical benefits, surgical risk (such as infection, bleeding, injury to other organ systems), potential surgical complications (such as mesh erosion, voiding dysfunction, urinary retention requiring indwelling catheter), bowel complaints (such as nausea, vomiting, constipation, diarrhea), and postoperative expectations (such as Foley management, pain management, activity restrictions, and diet. The following ERAS-specific components will be incorporated into the counseling: management of chronic medical conditions, cessation of alcohol and tobacco, and daily exercise until surgery. Questions from patients and total counseling time will be recorded.
15868922|NCT03890458|Drug|DEVIT-3|The physicians gave the women in the experimental group vitamin D oral drops in an ampoule of 300,000 IU and a vial of 50,000 IU to take during the IVF treatment. Written and verbal information about how to take vitamin D was provided to the participants by the nurses. The women took 300,000 IU vitamin D orally for the first week. In the second week of the treatment, 50,000 IU vitamin D (15 drops/day) was used as maintenance dose until the pregnancy test day.
15868923|NCT03890432|Device|GLUCOSAFE 2|Use of GLUCOSAFE 2 software for nutrition management and insulin-therapy
15868924|NCT03890432|Device|Local protocol control group with routine care|Use of the local protocols (electronic or paper version) for nutrition management and blood glucose control.
15868925|NCT03890432|Device|Historical control group with routine care|Use of the local protocols (electronic or paper version) for nutrition management and blood glucose control.
15868926|NCT03890419|Device|Green light|Green light exposure
15868927|NCT03890419|Device|Clear light|Full spectrum light exposure
15868928|NCT03890419|Device|Blue Light|Blue light exposure
15868929|NCT03890406|Drug|Rocuronium: PTC(Post-tetanic count) 1~2|Deep neuromuscular blockade will be maintained using continuous infusion of rocuronium.
15868930|NCT03890406|Drug|Rocuronium: TOF(Train-of-four) 1~2|Moderate neuromuscular blockade will be maintained using continuous infusion of rocuronium.
15868931|NCT03890393|Device|Electromyography|Muscle activity was bilaterally tested with needle electromyography at rest status, targeting at myofascial trigger points (MTrPs) in the frontal, temporal, sternocleidomastoid (SCM), splenius capitis, splenius cervicis and trapezius of each subject.
15868932|NCT03890380|Device|Magneto Wire|Patients will be treated with Magneto Wire
15868933|NCT03890367|Biological|Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid Conjugate vaccine|Pharmaceutical form: Liquid solution for injection Route of administration: Intramuscular
15868934|NCT03890367|Biological|Meningococcal polysaccharide group A, C, W-135 and Y Conjugate vaccine|Pharmaceutical form: Powder and solvent for suspension for injection Route of administration: Intramuscular
15868935|NCT03890367|Biological|Meningococcal group C polysaccharide Conjugate vaccine adsorbed|Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
15868936|NCT03890354|Procedure|Hand-Sewn Repair|gastotomy to identify and remove gastric subepithelium tumor and hand sawn repair
15868937|NCT03890341|Drug|Drospirenone/Ethinylestradiol|A single oral dose of drospirenone/ethinylestradiol 3 mg/0.02 mg (OC) tablets will be administered on Days 1, 13 and 19.
15868938|NCT03890341|Drug|Midazolam|Midazolam 2 mg will be administered orally on Days 1, 13 and 19.
15868939|NCT03890341|Drug|JNJ-64530440|A single oral dose of JNJ-64530440 2,000 mg will be administered on Day 6 and once daily on Days 13 to 22.
15868940|NCT03890328|Procedure|radiofrequency ablation|apply RF therapy to the treatment of splenic trauma
15868994|NCT03889886|Drug|Vehicle|Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
15868941|NCT03890315|Diagnostic Test|Functional MRI|"In fMRI, patients will first be taking a resting state phase in case of activations. In the block design phase, they will be given tactile stimuli in affected extremity, and then healthy extremity in 3 blocks, followed by pauses.
~Primary and secondary sensorial cortex, insular cortex, anterior cingulate cortex, preforntal cortex and amygdala activation will be chosen as regions of interest, and their activation will be recorded for analyses."
15868942|NCT03890302|Drug|FB704A|Administered by IV infusion
15868943|NCT03890302|Drug|Placebo|Identical in appearance and same excipients as FB704A, but without active compound. Administered by IV infusion
15868944|NCT03890289|Drug|Idelalisib|Idelalisib Plus Obinutuzumab In Patients With Relapsed/Refractory Follicular Lymphoma
15868945|NCT03890289|Drug|Obinutuzumab|Idelalisib Plus Obinutuzumab In Patients With Relapsed/Refractory Follicular Lymphoma
15868946|NCT03890276|Other|HMS EL&C training module|No additional information
15868947|NCT03890276|Other|Videos used to supplement live trainer|[Cherrie to add]
15868948|NCT03890263|Behavioral|Chronic Pain Self-Management Support|"Family physicians and nurse practitioners will participate in an academic detailing session with a pharmacist that focuses on safe, evidence-based opioid deprescribing. The pharmacist will provide pre-visit recommendations for each visit with a person on high doses of opioids. The pharmacist and healthcare providers will develop a patient centered, opioid taper schedule, with follow-up at 2 to 4 week intervals to assess for efficacy and safety.
~The self-management intervention will be Chronic Pain Self-management Support with Pain Science Education and Exercise (COMMENCE), which consists of 2 visits per week over 6 weeks. One visit per week is 1.5 hours in a group format. with education about self-management and pain science as well as cognitive behavioural principles. The 2nd visit each week is 30 minutes in a one-to-one format and is individually tailored to support implementation of self-management plans and development of an exercise program."
15868949|NCT03890250|Other|Aerobic exercise|A 20-30 minutes low-medium intensity aerobic exercise training with cycling ergometer.
15868950|NCT03890250|Other|Neuromuscular electrical stimulation|Bilateral NMES application on Quadriceps femoris muscle will be applied as symmetrical biphasic square wave current with a wave frequency of 35-60 Hz, phase transition time of 8 seconds and active resting time of 15 seconds
15868951|NCT03890237|Behavioral|Her Spaces|Her Spaces will comprise a set of activities leveraging the Her Spaces curriculum and program model which includes curriculum-based sessions for 11-13 year old girls, with 40 sessions delivered weekly over the course of 10 months
15868952|NCT03890237|Behavioral|Act With Her|Act With Her was designed to facilitate adolescent transitions to adulthood via improvements across the six GAGE domains (education, bodily integrity, health, psychosocial well-being, voice and agency, and economic empowerment). Project activities fall into three main categories: curriculum-based programming with adolescent girls and boys, community transformation, and systems strengthening. Act With Her will work with 10-13 year old girls and boys for 10 months and implement community-level and high-level system strengthening work up to 24 months (in rural and pastoralist areas).
15868953|NCT03890237|Behavioral|Act With Her + Asset Transfer|This arm will implement the Act With Her program described above, using program curricula with 10-13-year-old girls and boys over 10 months and conducting community-level systems strengthening up to 24 months. Additionally, the girls participating in this arm will receive one of three asset transfer options. The packages will be of equal value (115 USD) - one will include school supplies, one will include hygiene supplies, and will be a combination of both. Each adolescent girl will choose which package she would like to receive and will receive components of the package at 3 timepoints over the course of the first 10 months of the project.
15868954|NCT03890237|Behavioral|Act With Her (simple)|This arm will implement the Act With Her curricula described above with 10-13 year old girls and boys over 10 months. The adolescent groups will follow the same model (near-peer, same-sex mentors, 40 weekly meetings for girls, 18 meetings for boys, 4 of which are joint sessions for boys and girls, 6 sessions for parents), but will not include community-level systems strengthening activities
15868955|NCT03890224|Device|home ventilators|The 3 test treatments are home non-targeted NIV, home targeted NIV and rescue home NIV. COPD patients will be equipped with home ventilators and fitted with either nasal, oronasal or facial masks. All the ventilators used will be CE marked.
15868956|NCT03890211|Device|Non-Electric Infant Warmer|Electric warmers are the standard of care in developed countries, but are extremely costly, complicated with risk of causing both hypo and hyperthermia with misuse, and often not feasible in settings without stable electricity. Through a multi-institutional collaboration, the investigators have developed an electricity-free infant warmer.
15868957|NCT03890198|Biological|LCAR-C182A cells|Patients receive fludarabine (3×300 mg/ m^2) and cyclophosphamide (3×30 mg/m^2) IV on days -5 to-3, and then Patients receive CAR-T cells. PS：The specific dose of fludarabine and cyclophosphamide is adjusted according to the individual condition of the subject and the judgment of the investigator.
15868958|NCT03890185|Combination Product|Chemo + Low dose RT|Intervention will include chemotherapy using Docetaxel 75mg/m2 IV D1, Cisplatin 75mg/m2 IV D1.Radiathion therapy (LDFRT) using 50 cGy of radiation per fraction BID on the day of chemotherapy and the day after during induction i.e. 50 cGy x 4 times per cycle given for total of 2 cycles every 21 days.
15868959|NCT03890185|Drug|Chemo alone|Chemo alone: Intervention will include chemotherapy using Docetaxel 75mg/m2 IV D1 and Cisplatin (CDDP) 75mg/m2 IV D1 given for 2 cycles every 21 days.
15868960|NCT03890172|Other|20-100 ml venous blood will be drawn the from patient into sterilized centrifuge tube ,following centrifuge to separate PRP and at the bed side and tricked onto the ulcer twice weekly|topical application of platelets rich plasma after Centrifugation at diabetic foot ulcer to study group ,history taking . Ankle brachial index (ABI) measuring and laboratory testes including hemoglobin A1c ( HgA1)c,cbc and prothrombin time( pt) and prothrombin concentration ( pc)
15868961|NCT03890172|Other|standard treatment|Subjects in the control group will receive Standard Wound Care treatment for chronic ulcers according to accepted medical practices.
15868962|NCT03890159|Behavioral|Computer Assited Cognitive rehabilitation|Patients will receive their therapies 1 day a day, 2-3 days a week. The computer-aided cognitive rehabilitation group will perform simulation-based exercises, including exercises related to attention, in a special computer program (Cogniplus TR version) during therapy hours. The total duration of intervention will be 1 month.
15869042|NCT03889405|Device|INVU™|The subject will undergo continuous recording of the uterine contractions and the fetal heart rate (FHR) for 30 to 60 min using INVU™.
15868963|NCT03890159|Behavioral|Conventional Cognitive Rehabilitation|Patients will receive their therapies 1 day a day, 2-3 days a week. The home (paper pen) exercise group will take the necessary exercises on paper suitable for their respective levels and the daily tasks suitable for their functional needs and interests. The total duration of intervention will be 1 month.
15868964|NCT03890133|Behavioral|Ba-Duan-Jin|"Ba-Duan-Jin is a common form of self-healthcare Qigong exercise that has been practiced by Chinese people for at least eight hundred years.It consists of eight sets of simple movements. By combining meditation with slow, graceful movements,deep breathing, and relaxation, Ba-Duan-Jin practitioners believe it has the ability to move vital energy (Qi) throughout the body. Ba-Duan-Jin is also considered to be a multicomponent intervention that integrates physical, psychosocial, emotional, spiritual, and behavioral elements. While the biological mechanisms remain unclear."
15868965|NCT03890133|Drug|Pregabalin capsule|Pregabalin is one of the three medications (pregabalin, duloxetine, and milnacipran) that have been approved by the Food and Drug Administration (FDA) to treat fibromyalgia in US, and the only medicine that has been approved in China.
15868966|NCT03890120|Drug|Cilofexor|100 mg tablet administered orally once daily
15868967|NCT03890120|Drug|Placebo|Tablet administered orally once daily
15868968|NCT03890107|Device|OtoSight Middle Ear Scope|OtoSight imaging using a near-infrared laser
15868969|NCT03890094|Drug|Sufentanil|Patients were applied sufentanil and midazolam intravenously and topical anesthetized.
15868970|NCT03890081|Other|Questionnaire|Translate and culturally adapt the original English version of the Coping Strategies Questionnaire into Turkish
15868971|NCT03890068|Drug|Anlotinib Hydrochloride|48 subjects with advanced soft tissue sarcoma will receive anlotinib at a dose of 12 mg once daily (day1-14 PO) in 21-day cycles until disease progression (defined by RECIST version 1.1) or unacceptable toxicity.
15868972|NCT03890055|Drug|Anlotinib Hydrochloride|Best supportive care
15868973|NCT03890042|Drug|Dienogest group|VISANNE 2MG Tablet once daily
15868974|NCT03890042|Drug|Gestodene-Ethinyl Estradiol|Gynera tablet once daily
15868975|NCT03890042|Radiation|Ultrasound|ultrasound assessment of uterine volume
15868976|NCT03890042|Other|visual analogue scale|visual analogue scale for assessment of pain
15868977|NCT03890029|Behavioral|Intervention Training|After pre-testing and randomization, intervention participants will meet in small groups for 60 minutes/week over eight weeks for resilience training. Participants needing extra help will receive it at the end of each session. Controls will be on a minimal attention list, not being trained. After eight weeks, all participants will be post-tested.
15868978|NCT03890029|Behavioral|Control Condition|While intervention participants receive resilience training, the control group will not receive training but will receive minimal attention of a bi-monthly telephone call to indicate to participants that they are still enrolled in the study. A monthly flyer will be mailed to them about wellness and PTSD in recent news coverage. Following completion of an intervention group, participants and controls will be scheduled for post-testing that will be identical to the pre-testing and will occur within two weeks after the final treatment session. After the post-testing and 3-month follow up testing, the controls will be offered the resilience training.
15868979|NCT03890016|Diagnostic Test|20'Whole Blood ClottingTest (WBCT)|"1ml of blood drawn from snake bite victims in clean glass test tubes of 1 cm diameter Kept undisturbed for a period of 20 minutes (measured by a stop watch). At the end of 20 minutes the tube is tilted to see if the blood has clotted or not.
~If a well formed clot is not formed, the test is recorded as 'abnormal'.
~If the clot seems well formed, it is further observed for a period of 30 minutes to look for dissolution of the formed clot and would be termed clot lysis. Clot lysis indicates an unstable clot."
15868980|NCT03890016|Diagnostic Test|Modified Lee and White (MLW) Method Clotting Time|"The blood collected in three additional test tubes would be utilised for MLW.
~The three test tubes would be kept on a rack at ambient temperature.
~The blood sample would be drawn in a 5cc syringe and 1 ml would be added in the three test tubes consecutively.
~The test tube would be left undisturbed for 5 minutes, after that the first tube would be tilted approximately to check for clot formation every 30 seconds while the other tubes are left undisturbed.
~After the blood in the first tube has clotted, the time would be noted and the second tube would be tilted every 30 seconds and examined.
~Following its clotting, the third tube would be examined. The time at which the third tube is recorded as the CT value.
~Once clotted, then the sample in the all three test tube would be assessed at 20 minute and 30 min to look for breakup or lysis of the clot."
15868981|NCT03890003|Device|AID System|AID system
15868982|NCT03890003|Drug|Insulin Lispro|Individualized doses of insulin lispro administered via the AID system to maintain glycemic control, except during procedures designed to induce hyperglycemia and hypoglycemia.
15868983|NCT03889990|Device|IQOS|"Smoke IQOS"
15868984|NCT03889977|Other|Resistance exercise|2 major muscle groups (lower extremity, chest)
15868985|NCT03889964|Other|Measurement of lung function, electrocardiography, echocardiography and cardiopulmonary exercise testing|Measurement of lung function, electrocardiography, echocardiography and cardiopulmonary exercise testing
15868986|NCT03889938|Diagnostic Test|Serum and urinary assessment|Assess bioactive lipid mediators in blood and biopyrins in urine
15868987|NCT03889925|Drug|Hymovis|Patients will receive 2 intra-articular injections of autologous conditioned plasma and hyaluronic acid once a week for 2 weeks and a third injection on the third week of ACP.
15868988|NCT03889925|Biological|Autologous conditioned plasma|Patients will receive 3 intra-articular injections of autologous conditioned plasma dosed at once a week for 3 weeks.
15868989|NCT03889912|Drug|Cemiplimab|Each patient will receive intralesional injections of cemiplimab every week (QW) into the lesion at the assigned dose level for 12 weeks prior to scheduled surgery
15868990|NCT03889899|Device|Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)|An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.
15868991|NCT03889886|Drug|SDP-4 Ophthalmic Solution (0.1%)|Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
15868992|NCT03889886|Drug|SDP-4 Ophthalmic Solution (1.0%)|Investigational product (IP) will be administered via topical ocular instillation, one drop per eye, twice daily (BID) for 12 weeks (84 days). Both eyes will be treated.
15882785|NCT03783429|Drug|Placebos|Placebo tablets will be given orally
15868995|NCT03889873|Behavioral|Narrative Writing|An writing task in which participants are given a description of a possible future self (that varies 3 factors: topic; drinking vs. smartphone; perspective: 1st vs. 3rd-person; and social network: specifically asked to be included vs. not specifically asked to be included). Participants are asked to imagine that future self vividly and to write about the thoughts and feeling describe themselves and their experiences, the characteristics they hope or wish they will ideally possess, the characteristics that they would need to have and the roles they will take on or things they will be doing. Participants are given 20 minutes to think and write. They will write and think about the same future on each of three lab-sessions (which occur at 1-week intervals).
15868996|NCT03889847|Device|Fibreoptic intubation with silicone double lumen tube|Fibreoptic intubation with silicone double lumen tube
15868997|NCT03889847|Device|Fibreoptic intubation with PVC double lumen tube|Fibreoptic intubation with PVC double lumen tube
15868998|NCT03889834|Procedure|Autologous Blood Transfusion|Autotransfusion of packed red blood cells (200 ml) stored at 4 or -80°C for 31 days
15868999|NCT03889834|Other|No transfusion|no transfusion
15869000|NCT03889821|Behavioral|Parent-implemented Early Start Denver Model|The Parent-implemented Early Start Denver Model (P-ESDM; Rogers et al., 2012) consists of 12 consecutive sessions, each session approximately 1 hour long, that promote parental ability to support and interact with their young children with autism spectrum disorder (ASD). Intervention sessions are conducted in the clinic setting by therapists trained to fidelity by ESDM-certified parent trainers. The manualized intervention has a detailed parent-training curriculum, a specific coaching intervention method, and a therapist fidelity measure. Therapists introduce skills through descriptions, interaction, modeling, coaching, and feedback.
15869001|NCT03889821|Behavioral|Mindfulness Based Stress Reduction|The Mindfulness Based Stress Reduction (MBSR) protocol is derived from the work by Dykens et al. (2014), which is based on the stress reduction and relaxation program (Kabat-Zinn, 1982, 1990). In this study, it is offered as 6 weekly sessions that run concurrent with the P-ESDM intervention. Participants work one-on-one with a therapist for instruction and practice in mindfulness skills as well as discussions of stress, coping, and homework assignments.
15869002|NCT03889808|Diagnostic Test|Determination of serum anti-toxin Abs for C. difficile|
15869003|NCT03889795|Drug|Metformin|Metformin oral pill will be taken daily at breakfast (cohort 1) and breakfast and dinner (cohort 2 and 3).
15869004|NCT03889795|Drug|Simvastatin|Simvastatin oral pill will be taken daily in the evening.
15869005|NCT03889795|Drug|Digoxin|Digoxin oral pill will be taken daily in the morning.
15869006|NCT03889769|Diagnostic Test|OSNA test|Analysis of lymph node with OSNA
15869007|NCT03889756|Drug|Ketamine infusion|The dose of ketamine established in prior research (0.5 mg/kg over 40 minutes) will be used in this study to minimize risks. The maximum total single dose allowed in this study will be 40mg, corresponding to a weight of 80kg.
15869008|NCT03889756|Drug|Midazolam infusion|The weight-based midazolam dosing established in prior ketamine trials in adults (0.045mg/kg) will be used to minimize risks, as this is considered a very low dose compared to the sedation literature. The maximum total dose allowed in this study will be 3.6mg per infusion, corresponding to a weight of 80kg.
15869009|NCT03889743|Drug|Dexamethasone treatment during 3 days|Dexamethasone 1,5 mg oral tablets, may be halved into 2 x 0,75 mg. The exact daily dose of dexamethasone will be 0.3 mg/kg (maximum 6.0 mg). The recommended administration of all tablets is to crush the tablets to a smooth powder and then mix with jelly or yogurt. The dissolved dexamethasone is given by mouth and it is recommended to give it in relation to a meal/breastfeeding. If a child vomits within 30 min, the same dose will be given one more time after a break.
15869010|NCT03889743|Drug|placebo treatment during 3 days|1,5 mg oral tablets, may be halved into 2 x 0,75 mg. The exact daily dose of lactose (instead of dexamethasone) will be 0.3 mg/kg (maximum 6.0 mg). The recommended administration of all tablets is to crush the tablets to a smooth powder and then mix with jelly or yogurt. The dissolved dexamethasone is given by mouth and it is recommended to give it in relation to a meal/breastfeeding. If a child vomits within 30 min, the same dose will be given one more time after a break.
15869011|NCT03889717|Dietary Supplement|vitamin D|vitamin d drops will be given daily to the 2 groups of neonates ( 1st group will be given 400 iu /day and 2nd group will be given 1000 iu per day ) when they reach 100 cc per kg enteral feeding .. until they reach 40 weeks gestational age
15869012|NCT03889704|Device|Omnistim® FX²|The Omnistim® FX² is a neuromuscular stimulation device that provides patterned electrical neuromuscular stimulation (PENS) via cutaneous electrodes placed over relevant musculature. The device mimics physiologic patterns of neuron firing.
15869013|NCT03889691|Procedure|Third molar surgery|Surgical extraction of impacted lower third molar tooth under local anesthesia
15869014|NCT03889678|Diagnostic Test|Color flow doppler|Color flow doppler proximal to vein insertion site to document flow
15869015|NCT03889665|Other|Suspension training|Nine sessions of suspension training The suspension device will be TRX (R) The intervention will be administered in work:rest intervals (2:1) A global training approach will seek to train lower limbs, upper body and core musculature
15869016|NCT03889652|Diagnostic Test|Oct scans|Oct scans to assess thickness of RNFL and GCC before and after cataract extraction surgery in both groups
15869017|NCT03889639|Drug|SAR442168|Pharmaceutical form: Film coated tablet; Route of administration: Oral
15869018|NCT03889639|Drug|Placebo|Pharmaceutical form: Film coated tablet; Route of administration: Oral
15869019|NCT03889639|Drug|Locally approved intravenous contrast medium for contrast enhanced magnetic resonance imaging (MRI)|Pharmaceutical form: Solution for injection; Route of administration: Intravenous
15869020|NCT03889626|Drug|Apatinib|Apatinib: 500mg qd po, q4w
15869021|NCT03889626|Drug|Capecitabine|Capecitabine: 1000mg/m2 bid po, d1-14, q3w
15869022|NCT03889613|Other|prospective follow-up with videocapsule|prospective follow-up with videocapsule
15869023|NCT03889600|Other|REDD-CAT|After obtaining informed consent from a participant and gathering baseline data, the study RA will send a flag in the EMR to notify the nurse care manager that a patient has enrolled in the REDD-CAT pilot. The nurse care manager will then incorporate the administration of the REDD-CAT to the patient as part of standard care discharge planning. He or she will utilize the REDD-CAT results report as a guideline for generating appropriate referrals to address unmet social needs identified.
15869043|NCT03889405|Device|IUPC|The study participants will undergo continuous recording of the uterine contractions by IUPC.
15869024|NCT03889587|Procedure|Innervation|There will be simultaneous innervation of vascularized iliac or fibular bone flaps through neurorrhaphy between the nerves innervating iliac or fibular bones and recipient site.
15869025|NCT03889587|Procedure|Non-innervation|This will be the traditional method of vascularized iliac or fibular bone flaps, and neurorrhaphy will not be performed.
15869026|NCT03889561|Behavioral|Drink Tap|The Drink Tap intervention consists of increased access to safe and appealing drinking water, multicultural water promotion, and soda taxes.
15869027|NCT03889548|Other|Mental Imagery|Immediately after determination of the resting motor threshold and pre-test measurements, the TMS administrator will leave the room so as to be blinded to the treatment condition of the participant. At this time the participant will be given instructions regarding the mental imagery protocol from a separate investigator who will not be blinded to the condition. During the mental imagery protocol, participants will be instructed to close their eyes and imagine they are maximally contracting the muscles in their forearm and imagine that they are making their wrist flex and that they are pushing maximally against a hand grip in their hand. This will be a kinesthetic imagery task, in which they are urging their muscles to contract maximally.
15869028|NCT03889535|Device|Resin strip crowns|"Technique:
~I.Select shade of resin-based composite II.Rubber dam isolation III.Select primary incisor celluloid crown form with mesiodistal width similar to the tooth to be restored and trim the selected crown form to fit.
~IV.Remove decay with slow speed round bur. Perform pulp therapy, if indicated. V.Reduce incisal edge by 1.5 mm VI.Reduce interproximal surfaces by 0.5 to 1.0 mm with feather edge at gingival margin. The interproximal walls should be approximately parallel.
~VII.Reduce buccal surface by 1.0 mm and lingual surface by 0.5 mm with feather edge at gingival margins.
~VIII. Round line angles IX.Etch for 15 to 20 seconds, rinse and air dry X. Apply bond and polymerise XI. Fill crown form to 2/3 full with composite resin and seat onto the tooth. Remove excess material with hand instrument. Polymerise.
~XII. Remove celluloid crown form with scaler XIII. Finish and polish"
15869029|NCT03889535|Device|Zirconia crowns|I.Choose appropriately sized crown based on tooth's dimension; evaluate occlusion. II.Rubber dam isolation. III.Remove decay, perform pulp therapy if indicated. IV.Prep mesial half of incisal edge to complete thickness of 001 donut bur. V.Prep and blend distal half of incisal edge to create uniform incisal reduction. VI. Create chamfer margin at gum line at least half the thickness of bur tip. VII. Taper incisal half lingually to create a thin incisal edge. VIII. Remove cingulum and 0.75-1.25mm of lingual enamel; blend together forming smooth, slightly concave surface extending to tissue. IX. Thin incisal half. X.With 004 flame bur, remove chamfer margin at tissue level. Keep bur parallel to long axis of tooth. Remove chamfer in incremental steps, XI. Extend tip of bur full 2mm subgingivally. While hugging bur axially along root surface, make 3 circumferential passes. XII.Clean tooth and control bleeding. XIII.Cement crown with pure glass ionomer cement
15869030|NCT03889522|Diagnostic Test|Bioelectrical Impedance Analysis|BIA is a radiation-free and clinically accessible measure of body composition [47, 49]. An electrode is placed on the youth's extremities and they are asked to sit for 10 minutes. The youth's height and weight is manually inputted and the measure is obtained (approx. 90 seconds to complete). BIA sends a low level of electrical current through the body and measures the impedance to the current based on fat, muscle, bones providing a measure of body composition.
15869031|NCT03889522|Diagnostic Test|Total Body Dual-energy X-ray Absorptiometry|The DXA total body scan provides measurements of percent body fat, lean and fat free mass throughout the body. Youth lay on a table while the machine moves around them. The process takes about 3 minutes and 20 seconds.
15869032|NCT03889522|Diagnostic Test|Blood draw|Blood will be drawn to assess the following labs: HbA1c, leptin, lipid panel and comprehensive metabolic panel.
15869033|NCT03889496|Radiation|indium-111-exendin SPECT/CT|SPECT/CT imaging after injection with In-111-DTPA-exendin-4
15869034|NCT03889483|Device|NeuroCatch™ Platform|The NeuroCatch™ Platform consists of software and hardware that captures brain health information. The platform intends to provide a quick, portable and easy to use solution for the acquisition, display, analysis, storage, reporting and management of electroencephalograph (EEG) and event-related potential (ERP) information.
15869035|NCT03889470|Drug|NTG 1 MG/ML Injectable Solution|administered after sheath placement
15869036|NCT03889457|Other|anticoagulation choice|Type of anticoagulant chosen by the patient (oral or injectable).
15869037|NCT03889444|Drug|Dexamethasone intravitreal implant|Dexamethasone intravitreal implant 0.7 mg injection, as per routine clinical practice.
15869038|NCT03889431|Dietary Supplement|Iodine capsule|225 µg of iodine daily as a capsule of potassium iodide
15869039|NCT03889431|Other|Iodized Salt|450 g iodized salt provided for the household weekly. Salt iodine content was 30 to 40 mg iodine /kg salt as KIO3
15869040|NCT03889418|Behavioral|Electronic medical recorded clinical decision support [EMR CDS]|The opioid management tool has quick links to the Opioid Risk Tool (ORT), health maintenance reminders for risk mitigation tasks (pain management agreements; urine drug screening; prescribing naloxone); Pain Scale and depression/anxiety screen. The frequency with which providers are prompted to complete mitigation tasks is based on patients' level of risk for aberrant drug behavior defined by the ORT score. Additionally, the EMR CDS flags patients as high risk if one of the following criteria are met: (1) co-prescriptions for benzodiazepines; (2) active diagnosis of substance abuse in the last 12 months; or (3) MEDD >=90 mg. The ORT score, morphine equivalent daily dose (MEDD), and hyperlinks to the Louisiana pharmacy drug monitoring program data are visible in the prescription writer. If MEDD >=90 mg, the calculated MEDD is displayed in red font to alert the prescribing provider of high dosage. An Epic banner appears in charts to alert providers of existing pain management agreements.
15869041|NCT03889418|Behavioral|Stepped opioid collaborative care model [CCM]|The licensed clinical social worker (LCSW) will provide counseling services as indicated (behavioral activation, psychotherapy, crisis planning, facilitating connection to substance abuse counseling and treatment); meet weekly with the consulting psychiatrist for complex case review and care plan adjustments; and supervise the community health worker (CHW) case management and depression/anxiety care management activities. The CHW will update assets and barriers to recovery and self-management and help patients navigate community resources. The clinical pharmacist will review and reconcile active medication lists, assess medication side effects, drug interactions and adverse events; monitor analgesia; recommend algorithm based anti-depression medication titration as indicated. The consulting psychiatrist will directly co-manage patients with severe mental illness, substance abuse and complex medication regimens.
15882846|NCT03783000|Drug|BI 425809 mixed with [C-14]-BI 425809|Treatment R
15869046|NCT03889379|Drug|Administration of albuterol|Participants will inhale nebulized albuterol at a concentration of 2.5mg diluted in 3mL of normal saline for 20 minutes.
15869047|NCT03889366|Drug|Aprepitant 125 mg|Single dose in the fasted state during treatment period 1,2 or 3
15869048|NCT03889353|Device|BCI sessions|up to 3 test sessions (D-30) to eliminate BCI illiteracy, then 10 rehabilitation sessions of 90 minutes (D1-D5 and D8-D12) - Session content : Guided training - Control of an avatar (VR, first person view) of the affected limb by motor mental imagery decoded by a brain computer interface.
15869049|NCT03889340|Device|IQool|Subjects will undergo hypothermia therapy with the IQool system
15869050|NCT03889327|Behavioral|Neuropsychological Feedback & Psychoeducation (Cognition)|The customary practice of providing feedback on neuropsychological test performance can address patient misperceptions of cognitive impairment by distinguishing between perceived and objective neuropsychological test performance. Explaining how normative data is derived by comparison to same age peers, patients are able to better understand their current cognitive functioning. The proposed intervention will employ both psychoeducation and neuropsychological feedback for participants assigned to the treatment group, and psychoeducation for participants assigned to the control group. Both groups will watch 3 brief videos (exactly the same length in time) and answer two qualitative questions following each video.
15869051|NCT03889327|Behavioral|Psychoeducation (Health)|Information on importance of healthy eating habits and benefits of a healthy diet including medical outcomes such as reduced blood pressure, and decreased risk of stroke and cardiovascular disease. This intervention will also cover recommended serving sizes for daily helpings of fruits and vegetables, and ways to incorporate fruits and vegetables into meals throughout the day. The control intervention will include expert testimony from a nutritionist and expert dietician.
15869052|NCT03889314|Drug|Rosuvastatin 20mg|Statin Therapy
15869053|NCT03889314|Other|Placebo|Placebo
15869054|NCT03889301|Behavioral|E-E Video|The E-E video was developed by the research team and chronicles the story of Ana who while enjoying coffee with two family members, shares her challenges with depression and her successful outcome with therapy. The video utilizes the genre of the telenovela which creates an entertaining environment where the audience is captivated by the content and absorbs the messages portrayed.
15869055|NCT03889301|Behavioral|Discussion|Structured psychoeducation and pamphlet about anxiety and depression.
15869056|NCT03889288|Device|Medical device - electronic-pain killer|Treatment sessions with the medical device (no-marked EC): 2 sessions before surgery and 4 or 5 sessions until 48 hours after surgery. Each treatment sessions takes 45 minutes. Each session is spaced by 12 +/-3 hours.
15869057|NCT03889275|Biological|MEDI5395|Subjects will receive multiple doses of MEDI5395 over several days.
15869058|NCT03889275|Biological|Durvalumab|Durvalumab will be administered periodically for a maximum of 2 years or until radiologically confirmed disease progression, clinical deterioration, withdrawal of consent, or unacceptable toxicity
15869059|NCT03889262|Other|Hippotherapy|Hippotherapy is a therapeutic method in which a mechanical horse is used for therapeutic purposes.
15869060|NCT03889262|Other|Neurodevelopmental Therapy|Neurodevelopmental therapy (NDT) is a hands-on treatment approach used by physical therapists, occupational therapists, and speech-language pathologists. NDT was developed to enhance the function of children who have difficulty controlling movement as a result of neurological challenges, such as cerebral palsy and head injury. During treatment interventions, repeated experience in movement ensures that a particular pattern is readily accessible for motor performance. The more a patient performs certain movements, the easier these movements becomes.
15869061|NCT03889249|Drug|Tenecteplase|Stroke Thrombolytic
15869062|NCT03889249|Drug|Alteplase|Stroke Thrombolytic
15869063|NCT03889236|Other|Fasting mimicking diet Prolon|5-day fasting mimicking diet
15869064|NCT03889236|Dietary Supplement|Food supplement Endocalyx|Food supplement
15869065|NCT03889236|Dietary Supplement|Placebo|Placebo
15869066|NCT03889223|Procedure|Anatomical intervention with USG and comfort evaluation with NRS|The anatomical evaluation of the two neuraxial positioning techniques sonographically and comparison of comfort with the 7-point NRS
15869067|NCT03889210|Other|HVMN Ketone|Water-based, flavoured sport beverage
15869068|NCT03889210|Other|Placebo|Water, stevia, malic acid, and thickening agent
15869069|NCT03889197|Drug|Sodium supplementation guided by urine sodium concentration algorithm|4 mEq/kg/d sodium added the first time urine [Na] below threshold; for each subsequent time urine [Na] below threshold, add additional 2 mEq/kg/d.
15869070|NCT03889184|Other|rehabilitating meals-on-wheels service|the meals-on-wheels service will be specifically targeted for old people discharged from hospital, receiving exercise rehabilitation in the municipality or already receiving meals-on-wheels
15869071|NCT03889171|Behavioral|Behaviour|Comparison to psychological, medical and emotional Influencing communication and achievement factors to Oncogenetics tests
15869072|NCT03889158|Biological|Typhoid Vaccine/Ascorbic Acid|All participants will receive the typhoid vaccine and Vit C.
15869073|NCT03889145|Drug|Telmisartan 80mg|Telmisartan 80mg
15869074|NCT03889145|Drug|Amlodipine10mg|Amlodipine 10mg
15869075|NCT03889145|Drug|Hydrochlorothiazide|Hydrochlorothiazide 25mg
15869076|NCT03889132|Procedure|Bariatric Surgery|Subjects with obesity (N=60) will be undertaken a hypocaloric diet and a periodic follow up, also 30 of them will undergo bariatric surgery
15869077|NCT03889119|Radiation|Stereotactic Body Radiation Therapy (SBRT) radiation for prostate cancer utilizing the Elekta Versa or Agility System.|SBRT uses advanced imaging techniques to deliver targeted radiation to a tumor. The Elekta Versa and Agility Systems are approved by the Food and Drug Association (FDA) for SBRT treatment of cancer.
15869078|NCT03889106|Drug|Ribavirin|Standard of care: Intravenous administration of ribavirin at currently recommended dosages. Loading dose of 30 mg/kg (maximum 2 g), followed by 15 mg/kg (maximum 1 g) intravenously QDS for four days, followed by 7.5 mg/kg intravenously (maximum 500 mg) TDS for six days.
15869080|NCT03889080|Diagnostic Test|functional MRI|functional MRI scan of the brain
15869081|NCT03889067|Biological|Salmonella Typhi challenge|The challenge agents will be delivered in 30 ml of sodium bicarbonate solution, preceded by 120 ml of solution of sodium bicarbonate to neutralise gastric acid.
15882847|NCT03782987|Drug|BI 730357|Tablet
15869082|NCT03889054|Behavioral|Education program|"The education sessions will be given in 3 opportunities (15-30, 45 and at 90 days from diagnosis of the exacerbation) and it will be individualized. The program will include measures of self-care and self-management recommended in patients with COPD:
~Plan of action in an exacerbation.
~Education related to COPD.
~Information on pharmacological medication.
~Management of the exacerbation.
~Management of stress and / or anxiety.
~Nutritional recommendations.
~Physical exercise recommendations.
~Healthy lifestyle recommendations. The first session will last 90 minutes and will be explain according to the contents of the manual Controlling COPD. A presentation designed for this purpose will be displayed and this manual will be provided to patients to carry out their reading at home. The second and third sessions will last 15 minutes and the purpose will be to resolve doubts."
15869083|NCT03889041|Other|Quality of life assessment|The Turkish Feeding/Swallowing Impact Survey will be completed by the caregivers
15869084|NCT03889015|Dietary Supplement|Probiotic yogurt|Probiotics are found in different dairy products including yoghurt, that are known as carriers of probiotics. These products can be easily integrated in daily meals to reduce cariogenic streptococcus mutans bacteria in dental biofilm
15869085|NCT03889015|Dietary Supplement|xylitol chewing gum|Xylitol is widely used as an added sweetener in sugar-free products. It has been found to prevent dental caries through reducing dental plaque and limiting salivary streptococcus mutans counts and their produced levels of lactic acid
15869086|NCT03888989|Biological|Quadrivalent inactivated influenza vaccine (IIV)|Quadrivalent inactivated influenza vaccine (IIV), Intramuscular Injection
15869087|NCT03888976|Procedure|Cholecystectomy|Cholecystectomy with repair of duodenal wall.
15869088|NCT03888963|Procedure|PRF|patients will receive pulsed radiofrequency, 4 cycles (each cycle, 2 minutes) on the thoracic paravertebral nerves number 2,3, and 4 under fluroscopic guidance
15869089|NCT03888963|Procedure|SHAM|patients will be subjected to the same procedure like PRF group without giving PRF
15869090|NCT03888950|Diagnostic Test|FDG PET-CT|FDG PET/CT for oncological imaging of adult patients
15869091|NCT03888924|Drug|Bacille Calmette-Guerin vaccine|"One dose (0.1 mL) contains 50 μg of the semi-dry mass of BCG bacilli, i.e. from 150,000 to 600,000 of live BCG bacilli (Bacillus Calmette-Guerin), the Brazilian Moreau substrain.
~One ampoule or vial with the powder contains: 0.5 mg (from 1.5 mln to 6 mln) of live BCG bacilli (Bacillus Calmette-Guerin), the Brazilian Moreau substrain.
~Powder: monosodium glutamate. Solvent: isotonic solution of sodium chloride."
15869092|NCT03888924|Drug|Placebo|isotonic solution of sodium chloride (2mL vials).
15869093|NCT03888911|Dietary Supplement|High dose IQP-LU-104 (5120mg)|1 sachet to be taken 2 times daily orally, together with 2 main meals
15869094|NCT03888911|Dietary Supplement|Low dose IQP-LU-104 (2560mg)|1 sachet to be taken 2 times daily orally, together with 2 main meals
15869095|NCT03888911|Dietary Supplement|Placebo|1 sachet to be taken 2 times daily orally, together with 2 main meals
15869096|NCT03888898|Other|Reusable respirator fit test and competency evaluation|Feasibility of rapid conversion to reusable elastomeric respirator use during public health emergency
15869097|NCT03888898|Other|Control fit test evaluation|control comparator for fit testing time threshold
15869098|NCT03888885|Behavioral|Sport Education Model|A total number of 25 lecturers participated in the 12-hour CPD workshop on Sport Education curriculum on June 2018. The content of the workshop focused on the development of a Sport Education season, the changing roles of teachers and students, the assessment of personal and social responsibility, and the application of sport education season and related pedagogies on handball, badminton, swimming and physical conditioning. The Sport Education courseware and class materials were then designed by the eligible lecturers. The intervention was lasted for 10-lesson, 1-day per week and the duration for each lesson was around 90 minutes. The specific five phases in Sport Education model of team selection, teacher-directed, pre-season, formal competition and cumulating event were included. The eligible lecturers led the lessons according to the designated course wares and lesson plans for each sport.
15869099|NCT03888872|Device|High tone power therapy|"1- High Tone Power Therapy (HiTop 191): (For group I). The high tone power therapy through using a device (HiTop 191; gbo Medizintechnik, Rimbach, Germany).
~The intensity of the electrical stimulation will be adjusted to a pleasant level that did not produce any pain or discomfort. Duration: 60 min (Each one electrode to both thighs to the knee, each one electrode to both thighs to the groin). Position: lying / setting, Number of sessions: 10, Frequency of sessions: 3 times per week."
15869100|NCT03888872|Other|Selected Physical Therapy Program|"Selected physical therapy program: (For both groups).
~Wobble board training:
~Active range of motion exercises (AROM):
~Gentle manual stretching exercises for both UL & LL:
~Graduated gait training:"
15869101|NCT03888859|Biological|ET1402L1-ARTEMIS™ T cells -IV|Autologous T cells transduced with lentivirus encoding an anti-AFP (ET1402L1) -ARTEMIS™2 expression construct -intravenous (i.v.) arm
15869102|NCT03888859|Biological|ET1402L1-ARTEMIS™ T cells -intra-hepatic artery|Autologous T cells transduced with lentivirus encoding an anti-AFP (ET1402L1) -ARTEMIS™2 expression construct: intra-hepatic artery (i.a.) arm
15869103|NCT03888859|Biological|ET1402L1-ARTEMIS™ T cells -Intratumoral Injections|Autologous T cells transduced with lentivirus encoding an anti-AFP (ET1402L1) -ARTEMIS™2 expression construct: Intratumoral Injections (i.t.) arm
15869104|NCT03888846|Drug|Pentoxifylline|Topical gel version of pentoxifylline to be administered intraorally.
15869105|NCT03888846|Drug|Colchicine|Colchicine therapy is provided to patients with oral ulcers as part of supportive care routinely offered by Behcet's Clinic-Istanbul.
15869106|NCT03888833|Device|ECMO|ECMO installation
15869107|NCT03888820|Drug|Biofreeze|Biofreeze is a topical analgesic that uses the cooling effect of menthol, a natural pain reliever, to soothe minor muscle and joint pain. The product will be applied immediately after walking. The participant will wait 15 minutes prior to walking again.
15869108|NCT03888820|Drug|Placebo|The placebo is the Biofreeze product with all active ingredients removed. The product will be applied immediately after walking. The participant will wait 15 minutes prior to walking again.
15869109|NCT03888807|Drug|Biofreeze|Biofreeze is a topical analgesic that uses the cooling effect of menthol, a natural pain reliever, to soothe minor muscle and joint pain. The product will be applied immediately after walking. The participant will wait 15 minutes prior to walking again.
15869142|NCT03888482|Device|Somofilcon A contact lenses|Commercially available daily disposable soft contact lenses
15869110|NCT03888807|Drug|Placebo|The placebo is the Biofreeze product with all active ingredients removed. The product will be applied immediately after walking. The participant will wait 15 minutes prior to walking again.
15869111|NCT03888794|Device|Magnetic Resonance Imaging|Magnetic Resonance Imaging on pregnant women after 18 weeks of pregnancy with US diagnosis of congenital CNS fetal abnormality.
15869112|NCT03888781|Device|Echocardiography|An echocardiogram (also called an echo) is a type of ultrasound test that uses high-pitched sound waves that are sent through a device called a transducer. The device picks up echoes of the sound waves as they bounce off the different parts of your heart. These echoes are turned into moving pictures of your heart that can be seen on a video screen.
15869113|NCT03888768|Drug|MonoFer|Administration of IV Monofer will be given according to body weight as recommended by the drug manufacturer.
15869114|NCT03888755|Drug|Icatibant|Participants will receive icatibant 30 mg SC injection in the abdominal area.
15869115|NCT03888729|Drug|sofosbubir/velpatasvir|SOF/VEL (400 mg/100 mg) FDC once daily
15869116|NCT03888729|Drug|sofosbubir/velpatasvir/voxilaprevir|SOF/VEL/VOX (400 mg/100 mg/100 mg) FDC once daily
15869119|NCT03888703|Device|Fractional ablative CO2 laser|Three treatments with a fractional ablative CO2 laser 8 weeks apart
15869120|NCT03888690|Device|Virtual Reality Headset|Standardized procedures, with or without Virtual Reality Headset.
15869121|NCT03888677|Drug|5-FU, epirubicin and cyclophosphamide|Tailored dose escalation of epirubicin and cyclophosphamide.
15869122|NCT03888664|Drug|gamma interferon|1st two weeks: gIFN 100 ugr/three times a week from the 3rd week: gIFN 200 ugr/ three times a week for the following 22 weeks From the 25th week: no treatment for the following 24 weeks
15869123|NCT03888651|Other|Quality-of-Life Assessment|Complete quality of life assessment
15869124|NCT03888651|Other|Questionnaire Administration|Complete questionnaire
15869125|NCT03888638|Procedure|Hepatectomy|Removal of a part of the liver because of tumor
15869126|NCT03888625|Procedure|Conventional ILM Peeling|peeling with complete removal of the internal limiting membrane (ILM)
15869127|NCT03888625|Procedure|Inverted ILM Peeling|the inverted ILM peeling technique - the technique of Inverted flap described by Michalewska, in which the ILM is left in the edge of the macular hole and the free area is inverted over the macular hole before fluid-air exchange
15869128|NCT03888612|Drug|ARV-110|"Part A: Daily oral dosages are predetermined by cohort review committee after the initial starting dose cohort after the first 28 days of treatment
~Part B: Daily oral dosage and schedule at a recommended Phase 2 dose based on data from Part A"
15869129|NCT03888599|Behavioral|knowledge questioannaire|", all enrolled undergraduate student received directly on your email the online questionnaire based on the Fluid Survey tool, which was an on line survey tool (https://fluidsurveys.com/)"
15869130|NCT03888586|Device|Trigger Point Dry Needling Technique|The type of needle and the depth of the entrance varied depending on the estimated muscle thickness (0.25 - 25 mm, 0.25 - 30 mm and 0.25-40 mm). The disposable stainless-steel sterile needles were inserted through the skin over the trigger point in the taut band of muscle using the fast-in/out technique. Forward and backward needling was repeated until the local twitch responses were obtained. The depth of the needle was changed depending on the muscle thickness. After the first local twitch response, the needle was moved up and down 3 to 5 mm in only vertical directions until no more local twitch responses were elicited. After removing the needle, the insertion area was compressed with a piece of cotton
15869131|NCT03888586|Other|Deep Friction Massage Technique|For supporting the normal healing conditions, the deep and transverse friction causes hyperaemia in the involved soft tissue, which results in increased blood ﬂow to the area.
15869132|NCT03888573|Other|Stretching protocol|Patients within Stretch Group will receive stretching protocols to the cervical musculature at the side of symptoms. Traction Group will be treated with traction from 15-degree flexion, 30-degree lateral bending, and 15-degree rotation toward the painful side.
15869134|NCT03888547|Other|Occupational Therapy Health & Wellness Education|The OT Health and Wellness Program will have four weeks of education and individual integration intervention modules. One of the investigators will lead each of these weekly modules under the direct supervision of the Principal Investigator. Investigators will be trained to provide the standardized educational module for each topic area and for using outcome measures. Each module will have an identified theme and information provided in each group will be education to topic, evidence based literature on intervention strategies, lifestyle, or environmental modifications that improve performance of daily activities that will last approximately 45 minutes. After, group sharing of ideas and individual identification of weekly goals for integration of 1-3 targeted interventions will occur and last approximately 30-45 minutes).
15869135|NCT03888534|Drug|Ixazomib|Ixazomib intravenous injection in combination with reduction chemotherapy.
15869136|NCT03888521|Behavioral|Resound Relief smartphone app|The intervention is a smartphone app which has been developed to include a wide range of sounds and techniques aimed at reducing the impact of tinnitus.
15869137|NCT03888508|Other|SIT|"sensory integration therapy along with standard therapy.
~Primary care giver will be trained to perform sensory integration therapy at home.
~. Sensory interventions will include maneuvers for both hypo and hyper-reactive behaviors in five senses as tactile, vestibular, proprioception, vision and auditory using a sensory integration kit and other items available at home
~Daily sessions of approx 60 minutes/ day with each sensory stimulus given for 10-30 minutes 6 days in a week will be done."
15869138|NCT03888495|Behavioral|Gender Socialization Training workshop|Hands-on training workshops including lectures, group activities, role play and group discussions focused on gender socialization.
15869139|NCT03888495|Behavioral|Financial Literacy Training Intervention|Hands-on training workshops including lectures, group activities, role play and group discussions focused on financial literacy.
15869140|NCT03888495|Behavioral|Family Planning Counseling and Services|Family planning counseling sessions and linkage to services.
15869141|NCT03888482|Device|Verofilcon A contact lenses|Investigational daily disposable soft contact lenses
15869144|NCT03888469|Device|Etafilcon A contact lenses|Commercially available daily disposable soft contact lenses
15869145|NCT03888456|Other|osteopathic treatment|the intervention will be based on 2 phases: 1) assessment to identify areas with somatic dysfunction, 2) treatment to improve the function of the area identified
15869146|NCT03888456|Other|sham|the sham intervention will consists of 2 overlapping phases as the intervention group but without applying any technique
15869147|NCT03888443|Device|"Bimanual 3D Motion Analysis  Be-API "|"Movements will be measured using an optoelectronic system (12 cameras) which captures the displacement of 26 markers placed on the upper limbs and trunk of the child, according to the standards of the International Society of Biomechanics.
~The child is installed on a chair and table height (equipment adapted and approved for pediatrics). A game board is installed in front of the child, with objects to handle, set and placed according to its anthropometry (joystick, steering wheel, buzzer, board, chip)."
15869148|NCT03888430|Procedure|PtcCO2 measure during intubation|Transcutaneous measure during intubation. Non invasive measure without any risk according to the literature
15869149|NCT03888417|Device|Therapeutic plasma exchange (TPE)|All TPEs were performed by the centrifugation technique using the Fresenius Kabi COMTEC machine
15869150|NCT03888404|Other|Pregnancy preferences (Aim 1)|The primary exposure of interest for Aim 1 will be pregnancy preferences, measured with the Desire to Avoid Pregnancy scale.
15869151|NCT03888404|Other|Sociocultural environment (Aim 2)|For Aim 2 will assess the roles of contextual and individual variables on pregnancy decision-making and care-seeking outcomes (including state political environment, stigma, social emotional and instrumental support, feelings about the pregnancy, SES).
15869152|NCT03888404|Other|Pregnancy preferences (Aim 3a)|The primary exposure of interest for Aim 3a will be pregnancy preferences, measured with the Desire to Avoid Pregnancy scale.
15869153|NCT03888404|Other|Pregnancy (Aim 3b)|The exposure of interest for Aim 3b will be experiencing pregnancy. DAP level will be examined as an effect modifier.
15869154|NCT03888391|Device|Active TNS|
15869155|NCT03888378|Drug|0.3% Topical Minocycline Ointment|0.3% Topical Minocycline ointment to treat inflamed Meibomian Gland Dysfunction
15869156|NCT03888378|Drug|1% Topical Minocycline Ointment|1% Topical Minocycline ointment to treat inflamed Meibomian Gland Dysfunction
15869157|NCT03888378|Other|Topical Vehicle Ointment|Topical vehicle ointment to treat inflamed Meibomian Gland Dysfunction
15869158|NCT03888365|Drug|Treprostinil|Treprostinil treatment will be at the discretion of the participant's physician, and determined on an individual basis.
15869159|NCT03888365|Drug|Non-Treprostinil PAH Medications|Non-treprostinil treatment will be at the discretion of the participant's physician, and determined on an individual basis.
15869160|NCT03888339|Procedure|Commercially available high abutments placement|Patients will be randomly selected for the commercially available high abutments option. Two or three implants will be placed following the drilling protocol suggested by the manufacturer. Implants will be placed 0.5mm subcrestal. Once the implants have been placed, periapical radiographs and clinical pictures will be taken. Implants will be uncovered 10 weeks after being placed. After performing the incision and elevation a minimal flap, conventional high transmucosal abutments will be screwed using the torque recommended by the manufacturer. Once the abutments have been screwed, periapical radiographs and clinical pictures will be taken. The abutments will not be unscrewed thereafter throughout the study.
15869161|NCT03888339|Procedure|Modified shape abutments|Patients will be randomly selected for the modified shape abutments option. Two or three implants will be placed following the drilling protocol suggested by the manufacturer. Implants will be placed 0.5mm subcrestal. Once the implants have been placed, periapical radiographs and clinical pictures will be taken. Implants will be uncovered 10 weeks after being placed. After performing the incision and elevation a minimal flap, modified high transmucosal abutments will be screwed using the torque recommended by the manufacturer. Once the abutments have been screwed, periapical radiographs and clinical pictures will be taken. The abutments will not be unscrewed thereafter throughout the study.
15869162|NCT03888326|Device|1x1 anodal tDCS|20 minutes of 2mA anodal tDCS applied by a Soterix Medical 1x1 tDCS device while the participants are doing the robotic rehabilitation
15869163|NCT03888326|Device|Sham tDCS|Sham 2mA anodal tDCS applied by a Soterix Medical 1x1 tDCS device while the participants are doing the robotic rehabilitation
15869164|NCT03888326|Behavioral|Robotic Rehabilitation|10 days of robotic rehabilitation targeted at proprioception. Therapy is conducted for 1 hour each day for 10 consecutive days (excluding weekends), in combination with either anodal or sham tDCS.
15869165|NCT03888313|Other|Pretreatment group consultation|A consultation in group with several patients and one surgeon
15869166|NCT03888300|Other|Physiotherapy|Chest Physiotherapy, physical exercises
15869167|NCT03888287|Device|Watch Rx system|The Watch Rx system consists of a Watch Rx smartwatch, Watch Rx application and a WatchRx Web Interface. The Watch Rx smartwatch will be worn on the patient's wrist. The smart watch will send alerts to the caregivers through the Watch Rx app when it is time to administer the medication. The Web Interface will be used to store the medical documentations
15869168|NCT03888287|Other|Parkinson's Disease Inpatient Clinical Knowledge and Management Program|Parkinson's Disease Inpatient Clinical Knowledge and Management Program educates clinical staff and measures difference in knowledge of medication adherence and compliance for hospitalized Parkinson's Disease patients
15869169|NCT03888274|Device|ClearUP Sinus Pain Relief|Microcurrent Device Treatment
15869170|NCT03888261|Behavioral|Mind-Body Approaches for Medical Conditions|"The intervention programme of the present trial is delivered in a group-based format (15 participants per group) and overall applies three therapeutic components:
~Contemplative practices
~Psychoeducation
~Dialogue, including therapist-group dialogue as well as participant-participant dialogue."
15869171|NCT03888248|Device|Whole-body vibration|Home-based whole-body vibration therapy by standing on Galileo Med 15 platform for 9 mins twice a day for 5 days per week
15869172|NCT03888248|Other|Muscle strengthening exercises|Daily muscle strengthening exercises to be performed at home following a group education session by paediatric physiotherapist
15869689|NCT03883984|Drug|Placebo Oral Tablet|Placebo administered for 8 weeks. 125mg tablet QID.
15869173|NCT03888235|Procedure|Immediate corrective exercises|The sacroiliac forward flexion test (SIFFT) finds the position of each innominate bone. Subjects learn 1 of 3 exercises. To correct anterior rotation, flex the thigh hard against the ilium, pushing it backwards. To correct posterior rotation, hyperextend the thigh to pull the ilium forward. 1.Genuflect, anterior foot and posterior knee on the floor hands on the floor on either side of the foot, sliding the knee backwards to hyperextend the thigh. 2. Supine, anterior foot on an assistant's sternum, posterior thigh hyperextended. Assistant leans forward, forcing the anterior thigh against the ilium and pushing down on the posterior thigh. 3. For anterior rotation alone: anterior foot on a chair seat, pulling up hard with both hands, leaning back, forcing the thigh against the ilium. Hold position for 2 minutes. Use as needed for pain control. They are reassessed one month later when they receive the pelvic support belt. Both treatments used together will be assessed one month after.
15869174|NCT03888235|Device|Immediate use of pelvic support belt|"Participants will be given a pelvic support belt to stabilize their sacroiliac joints. The belt is fitted tightly around the pelvis, over the sacrum and below the anterior superior iliac spines (ASISs) to prevent opening the joint. (The upper part of the innominate bones flares out so pushing them inwards will move the lower part outwards, away from the sacrum, opening the sacroiliac joints, increasing their instability). They will use this belt for activities which have in the past precipitated back pain. They will be reassessed one month later.
~At that time they will be given the exercises to correct their sacroiliac malrotation and the concurrent use of both treatments will be assessed at their last visit one month later."
15869175|NCT03888235|Other|Delayed treatment|Participants will continue the treatments they are currently using to relieve their low back pain for one month. At their one-month visit, they will be taught how to assess the direction of sacroiliac malrotation and how to do the corrective exercise. They will also be fitted for a pelvic stabilization belt.
15869176|NCT03888222|Drug|Placebo Oral Tablet|"Fifteen (15) patients in group 1 will receive the matching placebo(sugar pill) one (1) tablet orally once daily for 3 months (90 days) ."
15869177|NCT03888222|Drug|Bosutinib Oral Tablet|Fifteen (15) patients in group 1 will receive the 100 mg of Bosutinib one (1) tablet orally once daily for 3 months (90 days) .
15869178|NCT03888209|Device|tDCS|20 minutes of anodal tDCS (C3/FP2 or C4/FP1 depending on side of lesion) 2mA or sham
15869179|NCT03888196|Dietary Supplement|Panax Ginseng Supplementation|500 mg/day of Panax Ginseng
15869180|NCT03888196|Dietary Supplement|Placebo Supplementation|500 mg/day of Cellulose
15869181|NCT03888183|Drug|salt solution without 0.15% HA|received AIM Artificial Tears (4 to 8 times per day) with 12 weeks
15869182|NCT03888183|Drug|preservative-free 0.15% HA|received Per-Young Eye Drops (4 to 8 times per day) with 12 weeks
15869183|NCT03888170|Other|No intervention|No intervention
15869184|NCT03888157|Drug|Liraglutide|Patients will be treated according to the Iranian label for Victoza®, following routine clinical practice and at the discretion of the study doctor. The study doctor will determine the intended maintenance dose of Victoza®, as well as any changes to the maintenance dose thereafter. Patients will be treated according to the Iranian label for Victoza®, following routine clinical practice and at the discretion of the study doctor. The study doctor will determine the intended maintenance dose of Victoza®, as well as any changes to the maintenance dose thereafter. The physician's decision to initiate treatment with Victoza® is clearly separate from the opportunity to include the patient in the study.
15869185|NCT03888144|Drug|Oxycodone|5 mg of oxycodone taken by mouth every 6 hours for 5 days
15869186|NCT03888144|Drug|Ketorolac|10 mg of ketorolac taken by mouth every 6 hours for 5 days
15869187|NCT03888131|Drug|CHF 1535 100/6 µg pMDI plus Symbicort® Turbohaler® Placebo|Fixed combination of beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg (BDP/FF)
15869188|NCT03888131|Drug|Symbicort® Turbohaler® plus CHF 1535 pMDI Placebo|Fixed combination of 160 µg budesonide + 4.5 µg formoterol fumarate (BUD/FF)
15869189|NCT03888118|Device|Luna EMG|The duration of the overall therapeutic intervention in both groups will be the same.
15869191|NCT03888092|Drug|Z650|receive oral Z650 once daily until disease progression or unacceptable toxicity occurs, each cycle is defined as 28 days
15869192|NCT03888079|Drug|Local anesthetic|1% or 2% lidocaine with 1:100,000 epinephrine, augmented by intravenous sedation and analgesia
15869193|NCT03888079|Drug|general anesthetic|Endotracheal intubation, intravenous narcotic agents, and inhaled agents
15869196|NCT03888053|Biological|BB-101|Within each cohort, 8 subjects will be randomized to receive BB-101 and 4 subjects to receive placebo.
15869197|NCT03888040|Other|Exercise|The participant will attend 3 training sessions per week for 8 weeks. Resistance training will be performed by each leg with a load of 30% of maximal strength: one leg with and the other without blood flow restriction.
15869199|NCT03888014|Device|GLOW800|The treatment group will consist of patients who require a medically necessary craniotomy. If an investigator deems that it will be useful to see blood vessels better with indocyanine green (ICG) videoangiography (VA), patients may be consented for the use if ICG VA using augmented reality (GLOW800). This will not add additional time or risk to their surgery
15869200|NCT03888014|Drug|indocyanine green (ICG)|This is a standard medication which can be given IV during a surgery to better visualize blood vessels under the microscope
15869205|NCT03887975|Procedure|Monoplane Occlusion|Monoplane and lingualized occlusion effect on force distribution
15869206|NCT03887975|Procedure|Lingualized occlusion|Monoplane and lingualized occlusion effect on force distribution
15869207|NCT03887962|Device|Virtual Environment Biofeedback|Treadmill walking. Modified available technology for gait capture. Tailored software for virtual environment rendering and immersive qualities
15869208|NCT03887962|Device|Treadmill walking with no Virtual Environment Biofeedback|Treadmill walking. Flat screen / no virtual environment to act as attentional control.
15869209|NCT03887949|Device|Group VCV|Volume controlled ventilation
15869210|NCT03887949|Device|Group PCV|Pressure controlled ventilation
15869211|NCT03887949|Device|Group PCV-VG|Pressure controlled ventilation with volume guarantee
15869212|NCT03887936|Drug|Testosterone gel 1.62%|Testosterone gel 1.62%, apply 2 pumps to upper arm and shoulder.
15869213|NCT03887936|Drug|Placebo|Matching placebo gel, apply 2 pumps to upper arm and shoulder
15869214|NCT03887923|Behavioral|Vestibular Physical Therapy|Balance, Gaze Stabilization, Habituation, and Walking exercises
15869215|NCT03887910|Other|Enhanced Intervention|Participants randomized to the Enhanced Intervention group will receive the Family Connects program, an evidence- based structure that begins at the birthing hospital stay, followed by 1 to 3 nurse home visits between 4 to 12 weeks of infant age, a follow-up contact one month later and a discharge home visit six months later and a final follow-up contact one month after that. During the home visits, the nurse engages with the mother and completes a holistic health and psychosocial assessment, during which the unique risks and family needs across 12 family domains are evaluated and addressed with either referrals with matched community resources or thorough education. In addition, they will be given a set of six developmental toys.
15869216|NCT03887910|Other|Intervention|Participants randomized to the Intervention group will receive the Family Connects program, an evidence- based structure that begins at the birthing hospital stay, followed by 1 to 3 nurse home visits between 4 to 12 weeks of infant age, a follow-up contact one month later and a discharge home visit six months later and a final follow-up contact one month after that. During the home visits, the nurse engages with the mother and completes a holistic health and psychosocial assessment, during which the unique risks and family needs across 12 family domains are evaluated. For each screened domain, the nurse is able to systematically address them, which may result in an immediate intervention; either referrals with matched community resources or thorough education.
15869217|NCT03887897|Procedure|Tracheal Intubation|Tracheal intubation performed by attending anesthesiologists using either Airtraq laryngoscope or Macintosh laryngoscope
15869218|NCT03887884|Drug|CVT-301|Levodopa Inhalation Powder
15869219|NCT03887884|Drug|Sinemet|Single oral dose of Carbidopa/Levodopa 25 mg/100 mg
15869220|NCT03887871|Drug|Harnal-D Tab.|Harnal-D Tab. 1T single oral administration after meal
15869221|NCT03887871|Drug|Chong Kun Dang Tamsulosin HCl Tab.|Chong Kun Dang Tamsulosin HCl Tab. 1T single oral administration after meal
15869222|NCT03887858|Drug|Harnal-D Tab.|Harnal-D Tab. 1T single oral administration under fasting
15869223|NCT03887858|Drug|Chong Kun Dang Tamsulosin HCl Tab.|Chong Kun Dang Tamsulosin HCl Tab. 1T single oral administration under fasting condition
15869224|NCT03887845|Procedure|Surgery|The respective surgical approach for any gastric and colorectal surgery
15869225|NCT03887832|Other|SMBI digital app|Digital platform on the smartphone for the media package
15869226|NCT03887832|Behavioral|media package|The SMBI app contains a <1 minute video of a mother and baby or just mother, a reflection question about the video, a few questions about their mood and stress, and some prompts and suggestions on what to do if they have problems.
15869227|NCT03887832|Other|standard newborn and infant care|Recommended standard pediatric primary care will be provided for infants up to 6 months.
15869228|NCT03887819|Diagnostic Test|Hystological evaluation|The original tissues samples will be fixed in 10% neutral buffered formalin and embedded in paraffin blocks. Sections (4 μm thick) will be stained with hematoxylin and eosin stain (H&E) for diagnosis. The immunohistochemistry for anti-LCA, anti-CD68, and anti-CD3 will be performed to identify the inflammatory infiltrate.
15869229|NCT03887793|Other|VACs|The VACs (Vaccinate Adolescents against Cancer) model for HPV vaccine quality improvement is a strategy developed by the American Cancer Society to improve HPV vaccination coverage in large integrated health care delivery systems. It includes the development of a quality improvement (QI) action plan, the formation of a QI team of health care providers, education for the QI team about HPV-related disease burden and vaccine efficacy, HPV vaccine coverage assessments at several time points that are shared with individual clinics within the health are system, and the adoption of specific QI strategies by participating clinics in the health care system.
15869231|NCT03887754|Drug|Risperidone|It is antipsychotic drug used by dose: 0.25 mg per day in children weighing less than (20 kg); 0.5 mg per day in persons weighing more for 8 months.
15869232|NCT03887754|Device|hyperbaric oxygen therapy|Sessions were done at pressure 1.5 ATA (atmosphere absolute) with 100% oxygen concentration, each lasting for one hour either in multiplace chamber or in monoplace chamber.
15869233|NCT03887754|Drug|Non specific Multivitamin|control group received non specific multivitamins as placebo for 8 months.
15869236|NCT03887715|Device|Vagus Nerve Stimulation (VNS)|VNS is an implantable device that delivers stimulation to the vagal nerve.
15869237|NCT03887702|Other|Best Practice|Receive best practice
15869238|NCT03887702|Drug|Entecavir|Given PO
15869239|NCT03887702|Drug|Tenofovir Alafenamide|Given PO
15869240|NCT03887702|Drug|Tenofovir Disoproxil Fumarate|Given PO
15869241|NCT03887689|Behavioral|Modified prolonged exposure|Participants will receive three sessions of modified prolonged exposure therapy.
15869242|NCT03887676|Drug|Arbaclofen|Administered orally as disintegrating tabs, round, white and beveled edges, at the following strengths: 5mg, 10mg, 15mg and 20mg
15869243|NCT03887676|Other|Placebo|Administered orally as disintegrating tabs, round, white and beveled edges
15869275|NCT03887403|Behavioral|Multimodal Intervention|
15869244|NCT03887650|Drug|Liposomal Bupivicaine 1.3%|10mL Liposomal Bupivacaine 1.3% (133 mg) mixed with 10mL of 0.5% Bupivacaine (total volume 20mL) in single injection interscalene brachial plexus block
15869245|NCT03887650|Drug|Bupivacaine 0.5%|20mL 0.5% Bupivacaine with 5 mg PF dexamethasone and 5 mcg epinephrine (total volume 20.5mL) in single injection interscalene brachial plexus block
15869246|NCT03887637|Drug|DAAs|Patients with CHC and cirrhosis who fulfills the indication of antiviral therapy will be administered with DAAs treatment.
15869247|NCT03887624|Drug|Ethosuximide|2 times/day, take it orally after breakfast/dinner; take 500mg in the morning and 500mg in the evening on day1, 500mg in the morning and 750mg in the evening on day2, 750mg in the morning and 750mg in the evening on day3, 750mg in the morning and 1000mg in the evening on day4, 1000mg in the morning and 1000mg in the evening on day5, maintain this dose until the end of treatment for 2 weeks.
15869248|NCT03887624|Drug|Placebo|2 times/day, take it orally after breakfast/dinner; take 500mg in the morning and 500mg in the evening on day1, 500mg in the morning and 750mg in the evening on day2, 750mg in the morning and 750mg in the evening on day3, 750mg in the morning and 1000mg in the evening on day4, 1000mg in the morning and 1000mg in the evening on day5, maintain this dose until the end of treatment for 2 weeks.
15869249|NCT03887624|Drug|Escitalopram|1 time/day, 20mg/day, take it orally after breakfast, take it for 4 weeks without interruption.
15869250|NCT03887611|Device|Ultrasound diagnosis|Ultrasound diagnosis of lesions with Samsung S-Detect and ECI technology
15869251|NCT03887598|Device|Ultrasound diagnosis|Ultrasound diagnosis of lesions with Samsung S-Detect and ECI technology
15869252|NCT03887585|Procedure|Achilles tendon lengthening|Achilles tendon lengthening by triple hemisection for Achilles tendon contracture
15869253|NCT03887572|Other|MOVIN|MOVIN is a multi-component unit-based intervention comprised of five components that are implemented simultaneously in a hospital unit. The five components are: 1) psychomotor skills training, 2) unit ambulation culture, 3) communication, 4) resources, 5) ambulation environment.
15869254|NCT03887559|Behavioral|Group-based stabilization and skill training in addition to individual treatment|"Group-based stabilization and skill training, weekly 2-hour sessions during 20 weeks. Based on the manual Tilbake til Nåtid (Back to here and now) (Holbæk, 2014) developed by clinicians in the highly specialized national trauma clinic 'Modum Bad's Trauma Clinic'."
15869255|NCT03887559|Other|Treatment as usual|Treatment as usual: conventional individual treatment (outpatient). Not standardized.
15869256|NCT03887546|Device|Inspiratory muscle trainer|The device incorporate a unidirectional valve independent of flow to guarantee constant resistance and included a specific pressure setting (in cm H2O).
15869257|NCT03887546|Procedure|Respiratory exercise|Respiratory exercise program involving nasal breathing and maximum exhalation during 12 weeks, 5 days/week, 15 minutes/day.
15869259|NCT03887520|Diagnostic Test|Blood draw for Lp(a)|Collect sample for Lipoprotein(a) testing
15869260|NCT03887507|Other|Vojta Therapy|Each session will consist of a 45-minute Vojta thera between py protocol based on three exercises, 15 minutes per exercise: Crawling reflex, and 1st phase and 2nd phase Rolling reflex.
15869261|NCT03887507|Other|Standard Program|The program consist in balance exercises targeting core stability, exercises of coordination and Pilates as well as individual sessions using the Bobath concept.
15869262|NCT03887494|Device|Implantation|Implantation of Y-Strut + cementoplasty in the femoral neck
15869263|NCT03887481|Device|"High-definition active tDCS (HD-tDCS) + Repeat After Me (RAM) Treatment"|"Device: Active HD-tDCS & Repeat After Me (RAM) Treatment
~Stimulation will be delivered by a battery-driven constant current stimulator. Electrical current will be administered to left supramarginal gyrus (L_SMG). The stimulation will be delivered at an intensity of 2 milliamperes (mA) (estimated current density 0.04 mA/cm2; estimated total charge 0.048 Coulombs/cm2) in a ramp-like fashion for a maximum of 20 minutes.
~Participants will receive RAM consisting of word span repetition span (increasing length, with/without response delay). Span tasks will be manipulated in terms of list length (single words, pair, triplets) and response delay (1 sec, 5 sec). Each list will consist of 10 spans. During each trial, participants will be asked to repeat words in the span after a response delay."
15869264|NCT03887481|Device|"Sham + Repeat After Me (RAM) Treatment"|"Device: Sham Current will be administered in a ramp-like fashion but after the ramping phase the intensity will drop to 0 mA. Current under the Sham condition will last for a maximum of 30 seconds.
~Participants will receive RAM consisting of word span repetition span (increasing length, with/without response delay). Span tasks will be manipulated in terms of list length (single words, pair, triplets) and response delay (1 sec, 5 sec). Each list will consist of 10 spans. During each trial, participants will be asked to repeat words in the span after a response delay."
15869265|NCT03887468|Device|EvoCit|hemodialysis using the combination of the Evodial dialyzer with a citrate enriched dialysate
15869266|NCT03887468|Device|EvoHep|hemodialysis using the combination of the Evodial dialyzer with a conventional bicarbonate based dialysate and systemic anticoagulation using unfractionated heparin
15869269|NCT03887442|Drug|Paclitaxel|Paclitaxel 80 mg/m2 may be infused, intravenously, every week.
15869270|NCT03887442|Drug|Cetuximab + Paclitaxel|Cetuximab 250 mg/m2 and Paclitaxel 80 mg/m2, both may be infused intravenously, every week. Cetuximab will be administered prior to paclitaxel.
15869271|NCT03887429|Drug|SXC-2023|SXC-2023 oral capsules
15869272|NCT03887429|Drug|Placebos|Matching Placebo oral capsules
15869273|NCT03887416|Drug|Dapagliflozin 10 MG Oral Tablet [Farxiga]|"The investigational medicinal product (IMP) is dapagliflozin10 mg given once daily (film coated tablets, oral use).
~Dapagliflozin will be administered through out the planned intervention period of the study (12 weeks).
~Dosage form and strength: 10 mg, Green, plain, diamond shaped, film coated tablet (orally)"
15869274|NCT03887416|Drug|Placebo Oral Tablet|"The comparator will be placebo oral tablet matching dapagliflozin 10 mg. Placebo will be administered through out the planned intervention period of the study (12 weeks).
~Dosage form and strength: Green, plain, diamond shaped, film coated tablet (orally). Does not contain active ingredient"
15869277|NCT03887390|Behavioral|Depression Medication Choice|The Depression Medication Choice tool is a series of cards emphasizing issues that are important for the patient and the health care professional when choosing antidepressants: weight change, sexual issues, sleep, cost, side effects, and stopping approach. The Depression Medication Choice tool uses clear language and is designed to improve the understanding of patients regarding the different attributes of antidepressants, and for use during clinical encounters.
15869278|NCT03887377|Drug|Botulinum Toxins|We will be comparing botulinum toxin following breast reduction surgery to placebo injection. We will then compare photos of each breast reduction scar at set intervals following surgery.
15869279|NCT03887377|Drug|Normal saline|Normal saline will serve as the placebo control on the contralateral breast
15869280|NCT03887364|Other|Group A-Diaphragmatic breathing|Patient was in casual and agreeable position in which gravity helped the stomach, for example, a semi fowler's position. Hand was put on the rectus abdominis just beneath the foremost costal edge and requested that the patient take in gradually and profoundly through the nose. Persistent was told to keep the shoulder casual and upper chest very, enabling the belly to rise marginally. At that point persistent was guided to remain loose and breathed out gradually through the mouth. The patient rehearsed this 3 to 4 times and the rest time frame was given so patient couldn't hyperventilate.This group was given 10 reps of 3 sets with 4 weeks of follow up
15869281|NCT03887364|Other|Group B-Icing and Airflow Stimulation|"Patient was lying comfortable in semi fowler position. Facial muscle icing was given using ice pack wrapped in cloth over cheeks and nose in butterfly pattern and over forehead for 5 minutes. Ice pack was applied on the patients face (around the cheek & nose) and accessory muscles (sternocleidomastoid muscles, upper trapezius) for single session of 5 to 10 minutes.
~After that airflow stimulation was given with the help of table fan. Table fan was placed on the central area of face. Duration of the fan for the patient was at least 5 minutes to relive dyspnea and distance kept approximate of 60 centimeter (2 rulers)."
15869282|NCT03887338|Other|Transnasal Fiberoptic Laryngoscopy|Use of Transnasal Fiberoptic Laryngoscopy during NIV titration to optimalize the NIV settings to laryngeal responses during the NIV treatment.
15869283|NCT03887325|Drug|Maxipost|To investigate the role of maxipost on cerebral hemodynamic and headache in healthy volunteers and migraine patients
15869284|NCT03887325|Drug|Saline|To investigate the role of saline on cerebral hemodynamic and headache in healthy volunteers and migraine patients
15869285|NCT03887312|Behavioral|t-CETA|Cognitive Behavioural Therapy (CBT) based approach delivered over the telephone. Components are available for common problems, including anxiety, depression, PTSD, conduct problems, substance abuse, and safety issues (including self-harm or suicidal ideation), and a tailored treatment package is produced for each child based on the presenting problem(s) and response to treatment. There are components for use with both child and caregiver.
15869286|NCT03887312|Behavioral|Médecins du Monde treatment as usual|Case manager-led care, with referral to a psychotherapist or psychiatrist as necessary. Médecins du Monde's approach is based on a joint collaboration between mental health trained case managers (who undergo extensive training by experts in the field on topics including Psychological First Aid, Child Protection, Gender Based Violence, etc.) and psychotherapists from different schools (providing Eye Movement Desensitization and Reprocessing [EMDR] for trauma, Interpersonal Therapy [IPT] for depression, Cognitive Behavioural Therapy [CBT], motivational counselling, familial or systemic therapy, and integrative approaches). Thus the number and content of sessions, and the person delivering treatment (case manager, psychotherapist, psychiatrist) vary.
15869287|NCT03887299|Combination Product|ReliaTect™ Post-Op Dressing (contains chlorohexidine gluconate or CHG)|Dressing will be applied in the operating room at the end of case and be in place until postoperative day 7
15869288|NCT03887299|Other|Standard Wound Care|Wound care will be administered as standard protocol in our institution
15869289|NCT03887286|Device|Philips EPIQ 7 ultrasound machine|Standard transthoracic echocardiography
15869290|NCT03887286|Device|Philips Lumify Broadband sector array transducer|Portable hand-held ultrasound device
15869291|NCT03887273|Biological|Q-Cells|cellular therapeutic comprised of human cells of the glial lineage
15869292|NCT03887260|Drug|Morphine PCA pump|Morphine given postoperatively.
15869293|NCT03887260|Procedure|ESP block|Regional anaesthesia technique performed under ultrasound guidance before surgery
15869294|NCT03887260|Drug|Fentanyl|Fentanyl administration during procedure, calculated per patient's weight and duration of surgery (minutes).
15869295|NCT03887247|Behavioral|E-mail Alert|Encrypted email to the following providers: the patient's opioid prescriber(s), benzodiazepine prescriber(s), and/or primary care manager. If there is more than one provider, they are copied together on the same message. The email identifies the concurrent prescriptions, details the patient's prescription history, includes relevant VA/DoD guidelines, states the risk of concurrent prescribing to patient, and provides action steps and relevant resources. When multiple providers are involved, the message encourages the providers to coordinate with each other and provides provider contact information to facilitate this communication.
15869296|NCT03887234|Procedure|Coracoclavicular ligament reconstruction|Arthroscopically conducted ligament reconstruction for the treatment of an AC dislocation
15869297|NCT03887221|Drug|Safinamide 50 mg|Safinamide 50mg film-coated tablets will be administered to subjects in Cohort 1. The subjects will receive the tablets orally in the morning, at 8:00±1hour, under fasting conditions, with 240 mL (total volume) of still mineral water. A mouth-and-hand check will be performed immediately after dosing to ensure treatment compliance.
15869298|NCT03887221|Drug|Safinamide 100mg|Safinamide 100mg film-coated tablets will be administered to subjects in Cohort 2. The subjects will receive the tablets orally in the morning, at 8:00±1hour, under fasting conditions, with 240 mL (total volume) of still mineral water. A mouth-and-hand check will be performed immediately after dosing to ensure treatment compliance.
15869299|NCT03887208|Procedure|Laser therapy|non-ablative fractional laser therapy of skin
15869300|NCT03887208|Biological|Autologous ADSC injection|Subcutaneous injection of autologous ADSC
15869301|NCT03887208|Procedure|Normal saline injection|Subcutaneous Normal saline injection
15869347|NCT03886883|Other|Exercise induced hypoalgesia (EIH)|An EIH response was induced by a 3-minute isometric contraction of the hand flexor muscles at 25% of maximal voluntary contraction (MVC).
15869348|NCT03886883|Other|Static stretch (SS)|Two bouts of 30 seconds of static stretching (SS) of the knee flexors.
15869302|NCT03887195|Other|Training mandatory module about the therapeutic relationship|"The training programme is composed by:
~2 lectures (optional)
~6 supervision sessions by Balint type groups (5 of which are mandatory);
~5 role-plays (all required);
~2 OSCE with patient actors (all required). This teaching is initiated by two lectures on the relationship, the awareness, the listening, the empathy, the therapeutic distance, and the personal impacts that affect the relationship.
~It included six sessions of Therapeutic Relation Training Groups inspired by the Balint groups. Five role-play sessions are also organized from January to May, the students could play the doctor or the patient. The scenarios are about the following themes: announcement of bad news; accompaniment of chronic disease; management of aggressiveness and hostility; etc. After the role-play, a feedback done by the teacher and the group helps to elaborate what has happened. Finally, a formative assessment will be made during the Clinical Objective Structured Examination."
15869303|NCT03887182|Diagnostic Test|functional MRI|Additional sequence (DTI) and functional MRI (fMRI) during the MRI which is done as part of the usual care
15869304|NCT03887182|Diagnostic Test|Automated Cortical Brainstem Auditory Evoked Potential|Automated Cortical Brainstem Auditory Evoked Potential correspond to a non-invasive EEG
15869305|NCT03887182|Genetic|whole exome sequencing|A study of all the DNA-encoding exons of the child/parent from a sample taken as part of the usual care
15869306|NCT03887182|Diagnostic Test|Standard Cortical Brainstem Auditory Evoked Potential|Standard Cortical Brainstem Auditory Evoked Potential correspond to a non-invasive EEG
15869307|NCT03887182|Diagnostic Test|multidisciplinary consultation|"multidisciplinary consultation is composed of:
~an ENT consultation and audiometry
~a speech therapy assessment
~a psychometric evaluation"
15869308|NCT03887169|Drug|Methionine|Administration of methionine from D1 to D60
15869309|NCT03887169|Drug|Vitamin B12, B9, B6, C supplementation|In case of hyperhomocysteinemia
15869310|NCT03887169|Diagnostic Test|Methionine/homocysteine Dosage|Plasma concentration control of methionine and homocysteine from D0 to D75
15869311|NCT03887169|Diagnostic Test|Thoracic CT scan|At D60
15869312|NCT03887169|Diagnostic Test|Abdominal and liver ultrasound.|At D60
15869313|NCT03887169|Diagnostic Test|Brain MRI|In case of abnormal neurological examination
15869314|NCT03887156|Diagnostic Test|Ex vivo capacities of CD4neg INkT expansion of the peripheral blood donor with the Predictor test|Calculation of ex vivo capacities of CD4neg INkT expansion of the peripheral blood from an identified donor for an allograft. Sample is collected before mobilization and the blood culture and analysis using the Predictor test are performed by the central lab.
15869315|NCT03887130|Drug|oral vinorelbine|Oral vinorelbine 60 mg/m² on day 1 & day 8, for cycle 1, and then 80 mg/m² on day 1 & day 8, every 3 weeks for subsequent cycles
15869316|NCT03887130|Drug|Capecitabine|Capecitabine 1000 mg/m² twice a day (2000 mg/m² daily) from day 1 to day 14
15869317|NCT03887130|Drug|Gemcitabine 1250 mg/m²|Gemcitabine 1250 mg/m² on day 1 & day 8
15869318|NCT03887130|Drug|Gemcitabine 1000 mg/m²|Gemcitabine: 1000 mg/m² on day 1 & 8
15869319|NCT03887130|Drug|Paclitaxel|Paclitaxel 175 mg/m² on day 1
15869320|NCT03887130|Drug|Docetaxel|Docetaxel 75 mg/m² on day 1
15869321|NCT03887117|Other|IQOS + Exercise Training Program|Switch to IQOS use + participation in a training program
15869322|NCT03887117|Other|No Training|Switch to IQOS use only, without participation in a training program
15869323|NCT03887117|Other|Cigarette Smoking + Exercise Training Program|Continue to smoke cigarettes + participation in a training program
15869324|NCT03887117|Other|Smoking Abstinence + Exercise Training Program|Switch to smoking abstinence + participation in a training program
15869325|NCT03887104|Device|SD-OCT|Spectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures
15869326|NCT03887091|Other|Postwire|Postwire© is a web-based, video platform
15869327|NCT03887078|Behavioral|Noom Coach for Bariatric Health|Noom Coach for Bariatric Health offers a sustainable, low-cost, coach-led intervention, and an innovative solution to issues with pre-bariatric surgery weight loss. The intervention will take place over 8 weeks pre and or post-surgery.
15869328|NCT03887065|Drug|JM-4|Novel small human peptide derived from erythropoietin
15869329|NCT03887052|Device|ASSURE™ Wearable Cardioverter Defibrillator (WCD)|WCD with shock alarms and shock functionality disabled
15869330|NCT03887039|Other|clinical examination|clinical examination for all the oral findings
15869331|NCT03887026|Drug|Norketotifen|Norketotifen oral capsule
15869332|NCT03887026|Drug|Placebo|Placebo oral capsule
15869333|NCT03887013|Drug|Trimetazidine|Trimetazidine is given as 20mg every time and three times per day (Tid) or 20mg every time and two times per day (when renal function is declined).
15869334|NCT03887000|Other|magnesium|Fibromyalgia patients taking either magnesium or placebo according to the randomized plan
15869335|NCT03887000|Other|placebo|Fibromyalgia patients taking either magnesium or placebo according to the randomized plan
15869336|NCT03886987|Device|Blue Non Sterile Powder Free Nitrile Examination Gloves|Approximately 2cm x 2cm square positioned to ensure that the inside portion of the test material maintained skin contact.
15869337|NCT03886961|Device|Reflux Band|The Reflux Band is to be worn when sleeping by lung transplant patients for 4 weeks starting 8 weeks after transplant.
15869338|NCT03886948|Drug|LY3074828|Administered subcutaneously (SC)
15869339|NCT03886948|Device|PFS|PFS used to administer LY3074828
15869340|NCT03886948|Device|AI|AI used to administer LY3074828
15869341|NCT03886935|Diagnostic Test|Metabolomics|
15869342|NCT03886922|Drug|Levcromakalim|Intravenous infusion of levcromakalim or placebo for 20 minutes. To investigate the role of levcromakalim/placebo on cranial arteries in healthy volunteers after glibenclamide administration.
15869343|NCT03886922|Drug|Saline|Intravenous infusion of levcromakalim or placebo for 20 minutes. To investigate the role of levcromakalim/placebo on cranial arteries in healthy volunteers after glibenclamide administration.
15869344|NCT03886909|Behavioral|Exercise|The exercise intervention is at least 2 weeks lasting (till the day transplant is taking place) 5-times weekly resistance training intervention combined with aerobic exercise (mostly walking).
15869345|NCT03886909|Behavioral|Prehabilitation Education|Participant will receive a prehabilitation and stem cell education class which will be held at the Penn State Cancer Institute.
15869350|NCT03886883|Other|Conditioned pain modulation (CPM)|A CPM response was induced by way of the cold pressor test.
15869351|NCT03886870|Behavioral|Lifestyle and work intervention|"The intervention period lasted for a year with three institution-based stays, 4 weeks at baseline and 2 weeks at 6 and 12 months. At baseline, participants got a functional assessment and an individual adjusted rehabilitation plan. At all three stages: The intervention contains activity training with a focus on the joy of movement, strength- and cardio-training. There were lectures and cognitive therapy to promote self-care and lifestyle change. The intervention contained lectures on diet, nutrition and cooking-classes. Participants set goals at baseline and adjusting these during the progress. Exercise programs was designed to use at home. The Cognitive Information Processing model of career guidance was the mainframe for the work dimension. All participants had talks with the work consultant at baseline, 6 and 12 months. Two work lectures, Duties and rights as employees and Work as medicine. When needed the work consultant contacted the employer in order to facilitate changes."
15869352|NCT03886870|Behavioral|Lifestyle intervention|"The intervention period lasted for a year with three institution-based stay, 4 weeks at baseline and 2 weeks at 6 and 12 months. At baseline, participants got a functional assessment and an individual adjusted rehabilitation plan.
~At all three stages: The intervention contains activity training with focus on joy of movement, strength- and cardio-training. There was lectures and cognitive therapy to promote self-care and lifestyle change. The intervention contained lectures on diet, nutrition and cooking-classes. Participants set goals at baseline and adjusting these during the progress. They developed exercise programs designed to use at home."
15869353|NCT03886857|Device|transcutaneous spinal cord stimulation|noninvasive electrical stimulation of the human lumbar spinal cord
15869354|NCT03886844|Dietary Supplement|Human milk fortifier based on human milk (Prolacta)|Intervention is started with an enteral intake of 100 ml/kg until 32 weeks corrected for prematurity, afterwards a human milk fortifier based on bovine milk is administered until estimated date of birth or 52 weeks corrected for prematurity (weight <10. percentile) according to ESPGHAN(=European Society for paediatric gastroenterology, hepatology and nutrition) guidelines
15869355|NCT03886831|Drug|PRT543|PRT543 will be administered orally
15869356|NCT03886818|Device|Standard dressings|Standard dressings will be used from surgery to wound healing
15869357|NCT03886818|Device|PICO strategy|The PICO system with negatif pression will be used from surgery to day 7. After that, standard dressing will be used untill the wound Healing.
15869358|NCT03886805|Other|Dual task with variable- and fixed-priority instructions|The participants were asked to perform dual-task activities focused, interchangeable or simultaneously, on balance (motor tasks) and on cognitive tasks performance, according to the instructional priority established by the physical therapist.
15869359|NCT03886805|Other|Dual-task with variable-priority instructions|The participants were asked to spend half the session focused on balance (motor tasks) and half the session focused on cognitive tasks performance, according to the instructional priority established by the physical therapist.
15869360|NCT03886792|Behavioral|Triggered reinforcement|This group will participate in a home-based experimental intervention for 10 minutes, twice/day for 10 days within 2 weeks. The infants will be supported in sitting with a tray secured anterior to the trunk. This intervention will involve reinforcement of biceps muscle activation in the affected arm if the infant generates a muscle contraction above a pre-set threshold (V). The threshold needed to trigger a toy to move and make sounds (reinforcement) will be set at baseline as determined by surface electromyography (SEMG). During the training time-points, the parent or care-giver will be allowed to sing or talk to the infant but are not to shake the toys or place dowel-based rattles or toys in either palm of the infant.
15869361|NCT03886792|Behavioral|Social interaction|This group will participate in a home-based dose-equivalent control intervention for 10 minutes, twice/day for 10 days within 2 weeks. The infants will be supported in sitting with a tray. This control program will combine social interaction between infant/parent with the opportunity for self-initiated play with toys repeatedly placed on the tray. A toy will be placed in front of the infant seat and tray but it will not be connected to the SEMG unit nor will the infant have an SEMG electrode attached over the biceps. During the intervention, the parent or care-giver will be allowed to sing or talk to the infant but are not to shake the toys or place dowel-based rattles or toys in either palm of the infant.
15869362|NCT03886779|Drug|Bromfenac|0.7 MG/ML [Prolensa]
15869363|NCT03886779|Drug|Nepafenac|3 MG/ML [Ilevro]
15869364|NCT03886766|Drug|Hot-melt extruded amorphous solid dispersion of Efavirenz|Hot-melt extruded amorphous solid dispersion of Efavirenz, 50 mg, oral administration (product 1)
15869365|NCT03886766|Drug|Hot-melt extruded amorphous solid dispersion of Efavirenz homogenized to drug rich particles|Hot-melt extruded amorphous solid dispersion of Efavirenz, 50 mg, homogenized to drug rich particles, oral administration (product 2)
15869366|NCT03886766|Drug|Efavirenz solution|Efavirenz solution, 3 mg, oral administration (product 3)
15869367|NCT03886753|Other|Registry|Collect data on subjects
15869368|NCT03886753|Other|PK microsampling of blood|Obtain 5 microsamples of blood from subjects via a fingerstick.
15869369|NCT03886740|Procedure|Reducing symptoms of Eustachian tube dysfunction|One of two methods of reducing Eustachian Tube dysfunction will be performed and the Eustachian Tube Dysfunction Questionnaire-7 (ETDQ-7) scores will be compared
15869370|NCT03886727|Device|Rubber Dam Set|Rubber dam set is the generic name of an isolation device that consists of a rubber sheet that isolates the tooth from saliva, a clamp to hold the rubber sheet on the tooth to be isolated, and a metal frame to keep the rubber sheet in a stretched position during dental procedures.
15869371|NCT03886727|Device|Dental Cotton Roll|Cotton roll is the generic name of a disposable isolation device made of cotton in a cylindrical form. Cotton rolls are used to isolate the teeth from saliva, by being placed in the cheek and tongue during placement of sealants or filings.
15869372|NCT03886714|Diagnostic Test|Screening for Fabry disease|Screening for the α-galactosidase (GAL) enzyme activity (men + women) and plasma Lyso globotriaosylsphingosine (GL3, women) for the diagnosis of Fabry disease.
15869373|NCT03886714|Diagnostic Test|Screen for α-galactosidase mutation|If necessary (positive for GAL), genetic confirmation tests for Fabry disease will be performed (men + women).
15869374|NCT03886701|Drug|Doravirine (DOR)|Non-nucleoside reverse transcriptase inhibitor indicated for the treatment of HIV-1 infection in adults in combination with other antiretroviral agents.
15882848|NCT03782987|Drug|Itraconazole|Oral solution
15869375|NCT03886701|Drug|Rifapentine (RPT)|Rifamycin anti-tuberculosis agent indicated for the treatment of latent and active tuberculosis infection.
15869376|NCT03886701|Drug|Isoniazid (INH)|Anti-tuberculosis agent indicated for the treatment of latent and active tuberculosis infection.
15869377|NCT03886688|Drug|HEC53856|oral administration
15869378|NCT03886688|Drug|placebo|oral administration
15869379|NCT03886675|Other|CO2 flushing|As above
15869380|NCT03886675|Other|Saline flushing|As above
15869381|NCT03886662|Drug|LB-100|"Phase Ib: Two escalating doses of LB-100 in two separate cohorts will be administered intravenously on days 1, 3 and 5 of a 21-day cycle over 120 minutes.
~Phase 2: Safe dose of LB-100 as determined from phase Ib will be administered intravenously on days 1, 3 and 5 of a 21-day cycle over 120 minutes."
15869382|NCT03886649|Drug|Copanlisib|Duration of IMP administration: a maximum of twelve 28-day cycles of the combination treatment. Copanlisib will be administered i.v. on days 1, 8, and 15 of each cycle. The only dose level 1 (DL1) is 60 mg copanlisib.
15869383|NCT03886649|Drug|Venetoclax|Duration of IMP administration: a maximum of twelve 28-day cycles of the combination treatment. Copanlisib will be administered i.v. on days 1, 8, and 15 of each cycle. The starting dose is dose level 1 (DL1): 600 mg venetoclax.
15869384|NCT03886636|Other|neuroscience pain education|A total of 4 NPE (Neuroscience paine education) sessions were held, once each week, before an MT session. The NPE sessions were conducted by an experienced physiotherapist certified in NPE in face-to-face, one-on-one sessions lasting 40-45 minutes. In NPE, the patient is taught about the physiology of pain, central sensitization, representation of the different body regions in the brain, pain-related changes in body perception, and the psychosocial dimensions of pain.
15869385|NCT03886636|Other|manual therapy|In our study, Manual therapy (MT) was individualized according to each patient's response to treatment. In this method, the physiotherapist identifies and performs techniques suitable for the patient's symptoms. If the selected techniques do not have a direct positive effect on the patient's symptoms, they are replaced with other techniques.MT were performed in a total of 8 sessions, held twice a week for 4 weeks. Treatment sessions lasted an average of 40-45 minute.The entire treatment program was carried out by the same physiotherapist who is trained and experienced in this area.
15869386|NCT03886636|Other|home exercises|All participants in all groups were assigned the home exercise program. The program aims to increase strength and flexibility of the abdominal, erector spinae, gluteal, quadriceps, and hamstring muscles. The participants were then asked to perform all of the exercises with 10 repetitions of each exercise 3 times a day for 4 weeks.
15869387|NCT03886623|Procedure|4-day systematic oral hygiene|he intervention proposed would include a 4-5 day systematic oral hygiene program. Using a pea-sized amount of Colgate Total Clean Mint Toothpaste with a Battery-operated Oral-B Pro-Health Type 3744 toothbrush, all surfaces, tongue-side, check-side, and biting surfaces of the participants teeth will be brushed. The tongue will be brushed with a GUM Dual Action Tongue Cleaner and flossing will be done with GUM Flossmate handle and Oral B Guide Floss in between the contacts of each tooth. The mouth will then be rinsed with Crest Pro-Health mouthwash rinse for 30 seconds twice daily. A Medline Remedy Phytoplex lip balm will then be applied.
15869388|NCT03886623|Other|Standard of Care oral care|Standard of Care oral care. Currently, the intensive care units utilize a commercially available pre-package oral hygiene kit. This includes mouthwash swabbing every 2 hours with Careline Alcohol-Free mouthwash or Sage Alcohol Free mouthwash, teeth brushing (with Sage Toothette Oral Care, Sodium Bicarbonate Toothpaste and Sage Suction Toothbrush) every 12 hours, deep oral suctioning every 8 hours and prior to oral Endotracheal tube (ET) retaping, and Paroex Oral Rinse chlorohexidine gluconate (15ml) swabbed onto oral surfaces every 12 hours (SICU patients only). Mouth care is documented every two hours.
15869389|NCT03886610|Other|Healthy controls|individuals without spinal cord injury
15869390|NCT03886610|Other|Subacute SCI patients|individuals with spinal cord injury ≥ 2 weeks
15869391|NCT03886610|Other|Chronic SCI patients|individuals with spinal cord injury ≥ 24 months
15869392|NCT03886597|Other|Table Olives|At early morning (08:00 h e.g.) and after 10 hours of fasting conditions, the olives of the Arbequina variety will be administered to each subject. The 60 olives will be weighted before the ingestion and the remaining stones will be subsequently weighted to keep a record of the amount of olive pulp that has been consumed. The subjects will have a period of 5 minutes to ingest 60 olives with 240 mL of water. Blood samples will be collected from 1 hour prior to administration until 24 hours after dosing. Urine samples will also be collected and blood pressure will be measured.
15869393|NCT03886597|Other|Table Olives|At early morning (08:00 h e.g.) and after 10 hours of fasting conditions, the olives of the Arbequina variety will be administered to each subject. The 120 olives will be weighted before the ingestion and the remaining stones will be subsequently weighted to keep a record of the amount of olive pulp that has been consumed. The subjects will have a period of 10 minutes to ingest 120 olives with 240 mL of water. Blood samples will be collected from 1 hour prior to administration until 24 hours after dosing. Urine samples will also be collected and blood pressure will be measured.
15869394|NCT03886597|Other|Table Olives|All the subjects will perform two experimental sessions of 30 days with 15 days of washout periods within experimental periods. In one experimental session subjects will ingest table olives and in the other session they will act as their own controls following their normal dietary habits. During all the experiment participants will avoid the consumption of products rich in phenolic and triterpenic compounds. Subjects will include the dose of 60 table olives within their normal dietary habits. Consequently, the olives will be consumed two times daily within each main meal; 30 olives before lunch and 30 olives before dinner. Blood samples will be collected at baseline and 15 and 30 days of each experimental session. Tolerability variables and blood pressure will also be measured.
15869395|NCT03886584|Other|Monitoring source test|Internal- and external-monitoring correct responses and inversions
15869431|NCT03886233|Drug|Corticosteroid Series|immunosuppressives are divided into alkylating agents (cyclophosphamide and chlorambucil), antimetabolites (methotrexate, azathioprine, and Mycophenolate Mofetil), and calcineurin inhibitors (cyclosporine, tacrolimus and sirolimus) Biological anti-inflammatory agents (for exapmle antagonists of tumor necrosis factor alpha like Infliximab and adalimumab).
15869432|NCT03886220|Drug|Elagolix|Oral; Tablet
15869433|NCT03886220|Drug|Placebo|Oral; Tablet
15869434|NCT03886207|Other|ginger powder footbath|38-40° C warm water footbath with an additive of dried ginger powder reaching up to mid-calf level, as practiced in anthroposophic medicine
15869396|NCT03886558|Other|A multicomponent intervention program was developed consisting of two 60-minute sessions per week, held on non-consecutive days, for a period of 8 months.|The sessions consisted of a warm-up phase (10') in which individuals performed joint mobility exercises and walked at a rate of 3 km/h. Afterwards, muscular strength work was carried out on the upper and lower limbs, including calisthenic exercises, and the use of dumbbells or medicine balls (1-3kg). Generally, the exercises were organized in two sets of 10-15 repetitions, resting for two minutes between sets. Communal ball games and relay games were then practiced (over a distance of 30 meters). Finally, 10 minutes were devoted to relaxation and stretching exercises. multicomponent intervention program was designed and monitored by a specialist in gerontogymnastics.
15869397|NCT03886545|Other|Assessment of physical and functional capacities|Comparaison of physical and functional capacities between caregivers with work-related musculoskeletal disorders of the shoulder healthy subjects matched in age and gender;
15869398|NCT03886532|Other|Medical Marijuana|registry and blood samples
15869399|NCT03886519|Procedure|BRAP (Bevel/rotate/advance procedure)|Trichiasis surgery using the BRAP procedure
15869400|NCT03886519|Procedure|Trabut|Trichiasis surgery using the Trabut procedure
15869401|NCT03886506|Biological|PLX-PAD|PLX-PAD 300×106 cells in a mixture containing 10% DMSO, 5% human serum albumin and Plasma-Lyte, will be administered via 30 IM injections (0.5 mL each) delivered into the leg twice,at 8 weeks interval.
15869402|NCT03886493|Drug|Dupilumab|dupilumab 600 mg SQ on day 1, and then 300 mg SQ on days 8,15, 22, 29, 36, 43.
15869403|NCT03886480|Device|SaeboVR|Use of the SaeboVR rehabilitation system for approximately 1 hour, 3 times per week for 4 weeks. Each intervention session will consist of the participant engaging in a series of virtual occupations involving their affected upper extremity and will include a 5 minute warm up activity followed by 3, 15 minute sessions of virtual occupation practice separated by 2, 5 minute breaks. The virtual occupations will include: grocery shopping, grocery storage, breakfast preparation, pet shopping, pet feeding, pet bathing, garden planting, garden harvesting, dinner preparation, closet organizing, and soup kitchen volunteering.
15869404|NCT03886467|Other|Community-based nutrition education|Nutrition education will be included in community development training. The nutrition education will target child nutrition, particularly consumption of animal-source foods and especially milk. The importance of dietary diversity will also be emphasized. Demonstrations of food preparation techniques will also be included in the training.
15869405|NCT03886441|Drug|Beclomethasone propionate|Beclomethasone propionate inhaled twice daily during radiotherapy
15869406|NCT03886428|Other|100% portion size|Entree portion size 100% of baseline
15869407|NCT03886428|Other|125% portion size|Entree portion size 125% of baseline
15869408|NCT03886428|Other|150% portion size|Entree portion size 150% of baseline
15869409|NCT03886428|Other|175% portion size|Entree portion size 175% of baseline
15869410|NCT03886415|Drug|Jaktinib hydrochloride tablets|Jaktinib hydrochloride tablets 100mg bid dose group and Jaktinib hydrochloride tablets 200mg qd dose group
15869411|NCT03886402|Device|GID SVF-2|Treatment of erectile dysfunction with the subjects own cells
15869412|NCT03886389|Dietary Supplement|PreOP|Mixture of Carbohydrates; standard amount designed for enhanced recovery after surgery (ERAS) i.e. preoperative carbohydrate loading before long standing surgery to enhance recovery.
15869413|NCT03886376|Other|Deep Massage|The deep massage group received 12 minutes of massage on the legs, arms and the back with three different sliding pressures.
15869414|NCT03886376|Other|Superficial Massage|The superficial massage group received 12 minutes of only one sliding pressure performed on the legs, arms and the back.
15869415|NCT03886363|Behavioral|MBSR|Described previously
15869416|NCT03886350|Other|blood and sputum samples|Blood and sputum samples for research purpose collected during routine tests performed at steady state and acute exacerbation
15869417|NCT03886337|Device|Germicidal lighting|Germicidal ambient lighting
15869418|NCT03886324|Combination Product|GIE Medical Drug Coated Balloon|Stricture patients treated by DCB
15869419|NCT03886311|Drug|Talimogene Laherparepvec 100000000 PFU/1 ML Injection Suspension [IMLYGIC]|Talimogene laherparepvec, 1Bil is given intratumorally every 2 weeks according to tumor size
15869420|NCT03886311|Drug|Nivolumab IV Soln 100 MG/10ML|NIVOLUMAB 240 mg IV over 30 min q 2 weeks
15869421|NCT03886311|Drug|Trabectedin 0.25 MG/1 VIAL Intravenous Powder for Solution|TRABECTEDIN 1.2 mg/m2 CIV over 24 hours q3 weeks
15869422|NCT03886298|Procedure|radiofrequency splanchnic denervation|the authors will denervate the splanchnic nerves via radiofrequency
15869423|NCT03886298|Procedure|retrocrural celiac denervation|the authors will denervate the splanchnic nerves in the retrocrural space via injection of alcohol
15869424|NCT03886285|Other|Questionnaire|Completion of the questionnaire by the patient after consultation with the general practitioner
15869425|NCT03886272|Drug|BI 730357 (Test)|tablet
15869426|NCT03886272|Drug|BI 730357 (Reference)|tablet
15869427|NCT03886259|Other|Neuromuscular exercises (NEMEX-TJR) and pain neuroscience education|"60min. of neuromuscular exercises (NEMEX-TJR) training two times a week for 3 months (12 weeks, 24 sessions). Physiotherapists will instruct and supervise the participants during the neuromuscular exercises. The aim of the neuromuscular exercise program is to restore normal movement, improve sensorimotor control, re-establishing normal motor program strategies and muscle activation.
~60min. of pain neuroscience education at the beginning of intervention period and after 6 weeks. Both sessions will take 60min. and will be conducted by physiotherapists. The aim of the pain neuroscience education is to increase the pain neuroscience knowledge of the patients leading to a better understanding of their chronic pain and thereby engaging the patients in the treatment of their chronic pain and impaired function."
15869428|NCT03886259|Other|Pain neuroscience education|60min. of pain neuroscience education at the beginning of intervention period and after 6 weeks. Both sessions will take 60min. and will be conducted by physiotherapists. The aim of the pain neuroscience education is to increase the pain neuroscience knowledge of the patients leading to a better understanding of their chronic pain and thereby engaging the patients in the treatment of their chronic pain and impaired function.
15869429|NCT03886246|Drug|Spesolimab|Solution for infusion
15869430|NCT03886246|Drug|Spesolimab|Solution for injection
15869435|NCT03886207|Other|warm water only footbath|38-40° C warm water footbath without any additive reaching up to mid-calf level
15869436|NCT03886194|Procedure|interventional treatment in pulmonary|Thrombolytic group: urokinase 20,000 units / kg body weight, 2 hours intravenous drip; or rtPA 50mg, 2 hours intravenous drip; and interventional treatment group: intracavitary catheter contact thrombolysis (urokinase 500,000 u 5 minute pulse Give), catheter thromboembolism, thrombus aspiration and mechanical thrombectomy.
15869437|NCT03886181|Device|Device: Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)|An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.
15869438|NCT03886168|Other|Signal processing intervention of a biomedical device|This is a signal processing intervention of an FDA approved biomedical device for study participants that have received the cochlear implant based on clinical recommendations (i.e. not study related). Based on image processing of pre- and post-implant CT, cochlear segmentation, electrode scalar localization, and definition of the electrode-to-neural interface, the investigators will manipulate the stimulus delivery of the incoming signal within the FDA approved clinical software and thereby is within the electrical and clinical specifications of the FDA approved device and accompanying software.
15869439|NCT03886155|Procedure|Biopsy|During clinically-scheduled trigger finger release surgery, soft tissue will be removed from the trigger finger tenosynovium (which may include synovial sheath and subcutaneous fat tissue) and send to pathology to be analyzed with amyloid-specific staining.
15869440|NCT03886142|Procedure|radiofrequency|radiofrequency of the genicular nerves
15869441|NCT03886142|Procedure|platelet rich plasma injection|intra articular injection of platelet rich plasma
15869442|NCT03886129|Diagnostic Test|Transcranial Doppler Ultrasound (TCD)|Participants will undergo an assessment of brain blood flow using TCD, with two small ultrasound probes held in place on the temples with a customised headframe. During the assessment, heart rate, breathing and blood pressure will also be monitored using a 3 lead ECG, nasal capnography and Finometer® respectively. The assessment will comprise three recordings. Firstly, participants will sit quietly for 5 minutes. Next, they will be asked to sit quietly for one minute before standing and remaining standing for 5 minutes. Lastly, they will be asked to stand and then complete a squat-stand manoeuvre in time with a computer sequence. A tilt sensor attached to the thigh will measure the efficiency and angle of the squatting motion. The squat-stand manoeuvre will consist of 15 squats and participants will be informed that they should try and complete all 15 squats if possible.
15869443|NCT03886116|Other|Exercise|3 sets of 10 forearm exercises performed twice in the Morning and Evening for 6 weeks.
15869444|NCT03886103|Drug|14C labeled PXL770|Single administration
15869445|NCT03886090|Behavioral|aerobic exercise|Single-bout of moderate intensity aerobic exercise on a cycle ergometer following motor skill practice
15869446|NCT03886090|Behavioral|rest|Seated rest following motor skill practice
15869447|NCT03886090|Behavioral|motor learning|Motor learning task on a stability platform (Stabilometer). Participants try to keep the tiltable platform in a horizontal position.
15869448|NCT03886077|Drug|glecaprevir/pibrentasivir|12 weeks of oral open label glecaprevir/pibrentasivir (Dose 3 tablets daily per package label).
15869449|NCT03886064|Other|Multi-behavioral intervention|The interventional group will then meet regularly under the aegis of the trainer to work on modifying each person's risk factors. The one-hour sessions will be scheduled every two weeks for two months and then every month for two months and then every three months until the end of the study (13 sessions). These sessions will be behavior change sessions, focused on goal setting, action planning, and problem solving. Trainers will facilitate these sessions and use motivational interviewing techniques
15869450|NCT03886051|Procedure|Connective Tissue Graft before Orthodontic treatment|Scaling and root planing will be performed and after resolution of periodontal inflammation, root coverage will be done using sub - epithelial connective tissue graft. Orthodontic treatment will be 3 months following the grafting procedure.
15869451|NCT03886051|Procedure|Orthodontic treatment only|Scaling and root planing will be performed and after resolution of periodontal inflammation, orthodontic treatment will be initiated.
15869452|NCT03886038|Biological|Shingrix|immunization with 2 doses of a subunit vaccine against herpes-zoster (Shingrix) administrated with at least 2 months apart
15869453|NCT03886025|Other|Anodal transcranial Direct Current Stimulation (tDCS)|Non-invasive brain stimulation
15869454|NCT03886025|Behavioral|Cognitive training|Iowa Gambling Task will be used for cognitive training
15869455|NCT03886025|Other|Sham transcranial Direct Current Stimulation (tDCS)|Non-invasive brain stimulation
15869456|NCT03886012|Device|Otoband|The Otoband will be used by participants during migraine associated vertigo (MAV). We expect the research subjects to use the device for at least 20 minutes, with the hardware limiting any one session to a duration of 30 minutes, up to 4 times per calendar day. The Otoband will be set to the effective power level during the course of a given calendar day.
15869457|NCT03886012|Device|Otoband sham|The Otoband will be used by participants during migraine associated vertigo (MAV) for a maximum of 30 minutes, up to 4 times per calendar day. The Otoband will be set to an ineffective power level (considered a sham device) during the course of a given calendar day.
15869458|NCT03885999|Device|Fecobionics|Fecobionics is a new device for studying defecation
15869459|NCT03885986|Radiation|Ultrasound|role of ultrasound in comparison to magnetic resonance imaging in diagnosis of benign cystic lesions of knee
15869460|NCT03885973|Drug|Lactobacillus plantarum|Fermented milk containing probiotic Lactobacillus plantarum for three weeks
15869461|NCT03885973|Drug|Placebo|Fermented milk containing placebo for three weeks
15869462|NCT03885947|Biological|Cord blood stem cells|CD34 selected VPA expanded umbilical cord blood cells used in combination with or without unmanipulated umbilical cord blood .
15869463|NCT03885947|Drug|Valproic Acid|Valproic Acid (VPA) expanded cord blood stem cells
15869464|NCT03885947|Drug|Fludarabine|Fludarabine 150 mg/m2
15869465|NCT03885947|Drug|cytoxan|Cytoxan 50 mg/m2
15869466|NCT03885947|Drug|Thiotepa|Thiotepa 10 mg/m2
15869467|NCT03885947|Biological|TBI|TBI 400cGy
15869468|NCT03885934|Biological|V114|V114 15-valent PCV containing 13 serotypes present in Prevnar 13® (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) and 2 unique serotypes (22F and 33F) in each 0.5 mL IM administration
15869469|NCT03885934|Biological|Prevnar 13®|Prevnar 13® 13-valent PCV containing 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) in each 0.5 mL IM administration.
15869473|NCT03885908|Other|in-person geriatric co-management|"The geriatrics service sees these patients for at least 2 postoperative days, if deemed clinically necessary by the geriatrician. During the inpatient hospital course, the geriatrics service will ensure the execution of preoperative recommendations and will discuss with the surgical team, who will act as a primary team, any additional recommendation in order to improve postoperative care. In-person geriatric consults to be done via telemedicine due to the current pandemic and consideration for patient safety."
15869474|NCT03885908|Other|automated geriatric co-management|Following completion of the eRFA, the summary of impairments as well as the recommendations generated by the study team (hard-copy or email) will be provided in real-time to the surgery team for their attention.
15869475|NCT03885895|Drug|Tranexamic Acid Injectable Product|Ampoules used for intradermal injection
15869476|NCT03885895|Device|Q switched KTP (532nm)|LASER
15869477|NCT03885882|Drug|E0302 SR1|E0302 SR1, oral tablet.
15869478|NCT03885882|Drug|E0302 SR3|E0302 SR3, oral tablet.
15869479|NCT03885882|Drug|E0302 SR2|E0302 SR2, oral tablet.
15869480|NCT03885882|Drug|E0302 IR|E0302 IR, oral tablet.
15869481|NCT03885869|Other|Ankle Joint Position Sensation Evaluation|In this test, individuals are placed in the supine position with their eyes closed for prevent visual cues; measurements are performed with the plex of the goniometer, 1.5 cm below the lateral malleol, the fixed arm parallel to the long axis of the fibula and the movable arm parallel to the long axis of the 5th metatarsal. Desired target angles were defined as 10 ° dorsi flexion, 10 ° plantar flexion and 20 ° plantar flexion. Individuals are instructed to focus on the position of the ankle joints in space for 5 s by bringing the feet in neutral position to the target position by the researcher. This procedure is repeated 3 times and the patient is expected to learn this position. The target angle is then asked to repeat in the testing phase. The measurement is repeated 3 times for each target angle. As a result criterion; By recording the absolute value of the deviation amounts from the target angles; The averages of the deviations during the 3 repetitions are averaged.
15869482|NCT03885869|Other|Knee Joint Position Sensation Evaluation|Bilateral knee joint position sensation will be evaluated in the literature with an analogue inclinometer(BASELINE®),which is a valid and reliable method for measuring joint position sensations.Measurements were planned to made in the sitting position,with the eyes of the individual closed and the joint to be evaluated bare,without any socks or shoes worn,fixing the inclinometer with a strap to the lower leg perpendicular to the knee flexion axis.In this measurement,the knees of the participants are passively shifted from the initial (90°flexion)position to the 30°flexion position,at this point 5 sec is waited and after they are told to keep this angle in mind,the starting position is returned.This procedure is repeated 3 times and the patient is expected to learn this position.After the individuals are rested for 5 s,they are asked to actively perform the target angle again.The same procedure was planned to be repeated 3 times for each angle at 45° and 60° knee flexion target angles.
15869483|NCT03885869|Other|The Evaluation of Plantar Sensation|"In the plantar sensory evaluation of the participants, Semmes-Wenstein Monofilament, which is frequently used in the literature and to be a reliable method in the diagnosis of neuropathy, was aimed to be tested by touching 7 regions on the foot base .
~In this evaluation, the individual is in the supine position, the physiotherapist is at the foot end of the patient; monofilament should be applied 90⁰ to the surface.
~The filament thickness which is the first feeling of the individual is recorded by being asked whether the individual is feeling. The 3 most commonly used monofilaments for patients with diabetic neuropathy are 4.17, 5.07 and 6.10 monofilaments. The highest monofilament value is the hardest and most difficult bending monofilament."
15869484|NCT03885869|Other|The Evaluation of Balance|In order to evaluate the static and dynamic balances of the participants, determination of open and closed postural oscillations and stability limits were planned with Prokin branded isokinetic balance system.
15869485|NCT03885869|Other|Evaluation of Dual Task Performance|"In order to evaluate double task performances, it is planned to evaluate 1 dynamic and 1 static 2 different performances, including Time Up and Go Test (TUG) and single leg standing time. For each performance; the single task, the motor second task and cognitive seconder tasks separately, and again for each application to be performed in such a way that two trials, the average time was planned to record. Motor and cognitive tasks for each test are planned as described below.
~Motor Task (TUG): Carrying cup full of water on tray. Cognitive Task (TUG): Counting the days of the week backwards from the current day Motor Task (Single Leg Standing Time): Hand-Over ball transfer Cognitive Task (Single Leg Standing Time): Counting backward month names from the current month"
15869486|NCT03885869|Other|General Evaluation Form|A form, which is prepared by us, including demographic information and physical characteristics of the individuals.
15869487|NCT03885856|Other|single row repair technique|single row repair technique
15869488|NCT03885856|Other|double row repair technique|double row repair technique
15869489|NCT03885843|Procedure|Renal nerve stimulation, mapping and denervation|After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal nerve stimulation, mapping and denervation procedure after randomization.
15869490|NCT03885843|Procedure|Sham Procedure: Renal angiography|After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal
15869491|NCT03885830|Drug|Bosutinib|Subjects will be enrolled into this group if they are receiving bosutinib per standard of care. This is an observational study and no interventions will be made.
15869492|NCT03885830|Drug|Dasatinib|Subjects will be enrolled into this group if they are receiving dasatinib per standard of care. This is an observational study and no interventions will be made.
15869493|NCT03885830|Drug|Imatinib|Subjects will be enrolled into this group if they are receiving imatinib per standard of care. This is an observational study and no interventions will be made.
15869494|NCT03885830|Drug|Nilotinib|Subjects will be enrolled into this group if they are receiving nilotinib per standard of care. This is an observational study and no interventions will be made.
15869495|NCT03885817|Behavioral|Exercise training and nutritional guide|30 minutes of a combination of sensorimotor- and strength training guided by a physical therapist twice a week. In addition 90 minutes a week of moderate intensity aerobic training or 45 minutes a week of high intensity aerobic training. Once a month the participants will fill out the form, PG-SGA SF, and he or she will be referred to a nutritionist if the score is 2 or higher. The intervention period lasts as long as the participants receives adjuvant chemotherapy, i.e. 3 - 6 months.
15869496|NCT03885817|Other|Standard follow-up care|standard recommendations regarding physical activity and nutrition during the period with adjuvant chemotherapy.
15869497|NCT03885804|Drug|Quadratus lamborum dexmedetomidine intravenous|Patients will receive quadratus lamborum block on the same surgical side then a bolus of 0.5 ml/Kg bupivacaine 0.25% in addition to 2ml normal saline will be injected then dexmedetomidine (precedex 200 micrograms per 2ml, Abbott laboratories, Abbott park, IL, USA) which will be prepared in concentration 1μg/ml. 1ml/kg loading dose will be given over 10 min followed by 0.5 ml/kg/h infusion maintenance dose till the end of surgery
15869498|NCT03885804|Drug|Quadratus lamborum dexmedetomidine perineural group(|Patients will receive quadratus lamborum block on the same surgical side then1μ g/kg diluted to 2 mL with 0.9% saline added to 0.5 ml/kg of 0.25% bupivacaine in addition to saline infusion 1ml/kg IV loading dose followed by by 0.5 ml/kg/h infusion maintenance dose till the end of surgery.
15869499|NCT03885791|Device|vaginal cryotherapy|"Both groups will be given the same instructions for use, which will include intravaginal placement of one tube for 10 minutes while resting in a supine position. A lubricant may be used for comfort with insertion.
~Patients will perform their first intervention in the office with a repeat examination within 10 minutes of completing therapy. Patients participating in Specific Aims #2 will perform the intervention once daily at home. Patients will be asked to complete a short diary for each session, which will include the time of day, duration of application, pain score prior to and after application, and presence of any pelvic floor disorder symptoms prior to and after application."
15869500|NCT03885778|Drug|Besifovir dipivoxil|150mg Besifovir dipivoxil, single dose, oral
15869501|NCT03885765|Diagnostic Test|Predictive data|"The novel predictive data in this study includes 5 predefined variables derived from thoracic CT scans:
~(i) Expiratory to inspiratory ratio of mean lung density (MLDe/i), total; (ii) MLDe/i of the section to be excised / MLDe/i total; (iii) Percentage of emphysema according to voxel thresholding at -950 HU (PVOX-950), total; (iv) PVOX-950 for the section to be excised; (v) Iodine concentration [I] of the section to be excised / [I] total."
15869502|NCT03885765|Procedure|Lung resection|Surgical resection will be characterised by type (pneumonectomy, bi-lobectomy, lobectomy, or lobectomy with anastomosis resection), whether or not lymph node dissection was performed, and whether or not the resection was atypical.
15869503|NCT03885752|Drug|chewed mint gum|In the preoperative waiting area before transferring to the operating room, patients in group G chewed mint gum for 2 minutes and then spit it out.
15869504|NCT03885752|Other|swallow twice|asked to swallow twice without any additional treatment.
15869505|NCT03885739|Other|Continuous Pericapsular Nerve Group block|Continuous Pericapsular Nerve Group block to standardize the approach. Injections were performed using a curvilinear low-frequency ultrasound probe (3.5- to 5-MHz). The lateral border of iliopsoas tendon in an oblique axial plane at level of iliopectineal eminence provides target for needle placement. Toggling the transducer was necessary to optimize visualization of the iliopsoas tendon secondary to anisotropy. Injections were performed using an 18-gauge Tuohy needle under sterile conditions. Then, 10 mL 0.25% bupivacaine was administered and a 20-G polyamide catheter (connect to a filter) was advanced into the space. The end point of the catheter placement was the direct visualization of microbubbles in a peritendinous distribution using a bolus of agitated saline applied through threaded catheter connected to not purged filter. After catheter placement patients received a 0.1% bupivacaine continuous infusion at a constant rate.
15869506|NCT03885726|Device|Precision Flow Plus|High velocity nasal insufflation
15869507|NCT03885726|Device|Treatment as Usual|Conventional therapy per institution
15869508|NCT03885713|Biological|Infliximab or adalimumab or golimumab or vedolizumab or ustekinumab|Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use) per clinical practice or adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus) per clinical practice or golimumab (subcutaneus 50 mg milligram(s)-subcutaneus) per clinical practice or vedolizumab (infusion 300 mg milligram(s)) per clinical practice or ustekinumab (subcutaneous 90 mg milligram(s)-subcutaneus) per clinical practice
15869509|NCT03885700|Behavioral|Educational program for 2 months|"The intervention was suggested based on the recommendations for adolescents' healthy diet and physical activity, it was derived from the 2008 Physical Activity Guidelines for Americans and Dietary Guidelines for Americans, 2010 by the U.S. HHS, Physical activity guidelines for children and adolescents by CPS 2012. The Food Guide Pyramid by the USDA, Nutrition &Healthy Eating by Mayo clinic & CDC website. The program was modified according to the age of the child. This plan was typically pursued in a School-based Intervention to Promote Healthy Lifestyles in Sousse, Tunisia, by Harrabi et al. The 1st month covered the healthy diet & the 2nd month covered the physical activity as follow:
~1st & 5th week: A 60-minutesession in health education.
~2nd & 6th week: Group counselling.
~3rd & 7th week: Students were divided into 8 groups & each group was asked to make presentation about a task related to the topic.
~4th & 8th week: Discussing the presentation."
15869510|NCT03885687|Behavioral|Exercise with Music|The Exercise with Music intervention is recorded exercise playlist, which provide exercise instructions tailored to patients' musical choices and exercise capacity.
15869511|NCT03885687|Behavioral|Exercise|The exercise group will receive exercise brochure and will be advised to exercise at least twice daily.
15869512|NCT03885674|Other|Video Call Reminder Condition|Receive daily video call reminders from Kessler Foundation research staff directly at the time of each medication dose and instructed to take the medication while on the video call.
15869513|NCT03885674|Other|Automated Text Message Reminder Condition|Receive daily automated text messages at the time of each medication dose and will be instructed to take the medication at that time. Each text message reminder will also contain a photo of the medication to be taken. On a weekly basis, study personnel will contact participants in this group to make sure they are receiving the text messages appropriately.
15869514|NCT03885661|Drug|Icosapent Ethyl 1000 MG [Vascepa]|Icosapent ethyl is an ethyl ester of the omega-3 fatty acid eicosapentaenoic acid (EPA). The empirical formula of icosapent ethyl is C22H34O2 and the molecular weight is 330.51. The chemical name for icosapent ethyl is ethyl all-cis-5,8,11,14,17-icosapentaenoate.
15869515|NCT03885635|Procedure|Hemiarch repair|Current standard of surgical repair consisting of ascending aortic replacement with open distal anastomosis at level of proximal arch under a period of hypothermic circulatory arrest . No surgical or endovascular intervention is carried out in the mid arch or descending aorta. Intra-operative management, including cannulation, cardioplegia, cerebral perfusion technique, and neurologic monitoring will be done according to each institution's current standard of practice.
15869516|NCT03885635|Procedure|Extended arch repair|Surgical replacement of the ascending aorta along with intervention on the arch and descending aorta. Techniques for distal aspect of extended arch technique include but are not limited to total arch replacement along with TEVAR, Frozen Elephant Trunk procedure or surgical proximal arch replacement with bare metal stents in arch and descending aorta. Intra-operative management, including cannulation, cardioplegia, cerebral perfusion technique, and neurologic monitoring will be done according to each institution's current standard of practice.
15869517|NCT03885622|Device|ANTHEM™ CR Total Knee System|The ANTHEM CR Total Knee System is a CE marked device. It is a cruciate retaining (CR) total knee system. It is intended to be used in patients for primary total knee replacement surgery where the posterior cruciate ligament and collateral ligaments remain intact. It is a comprehensive system which allows surgeons to address simple to complex knee arthroplasties.
15869518|NCT03885609|Device|ToothWave|RF-utilizing powered toothbrush for teeth whitening
15869519|NCT03885609|Device|powered toothbrush|regular powered toothbrush with no RF
15869521|NCT03885583|Procedure|thoracic epidural block|thoracic epidural block with bupivacaine 0.25% will be given in the 8th thoracic space using ultrasound
15869522|NCT03885583|Procedure|paravertebral block|paravertebral block with 0.25 bupivacaine will be given at the level of the incision using ultrasound
15869523|NCT03885570|Procedure|Mitral valve replacement|Blood transfusion
15869524|NCT03885557|Other|Group I Experimental DOS|After the application of hot pack treatment of 7-10 minutes, dynamic oscillatory stretch(DOS) technique (30 repetitions each of 2 seconds stretch duration in one session) was applied to DOS group. An experienced orthopedic manual physical therapist provided these techniques to patients .
15869525|NCT03885557|Other|group II SS group|After the application of hot pack treatment of 7-10 minutes , Static stretching (2 repetitions each of 30 seconds in one session) was applied to SS group. An experienced orthopedic manual physical therapist provided these techniques to patients .
15869526|NCT03885544|Other|Controlled Lacto-ovo vegetarian diet|Subjects will be randomized and assigned into an intervention to consume the controlled lacto-ovo vegetarian (LOV) diet for 3 weeks. All foods will be provided to subjects during the intervention. Each subject's energy requirement will be estimated using sex-specific equations published by the Institute of Medicine for weight maintenance during the intervention.
15869527|NCT03885544|Other|Controlled Unprocessed red meat diet|The unprocessed red meat diet will be the same as the LOV diet except that one 3-ounce portion of unprocessed red meat per day, 7 days per week (21 oz/wk) will be included. The unprocessed red meat will include beef tenderloin and pork loin. All foods will be provided to subjects during the intervention.
15869528|NCT03885544|Other|Controlled processed red meat diet|The processed red meat diet will be the same as the LOV diet except that one 3-ounce portion of processed red meat per day, 7 days per week (21 oz/wk) will be included. The processed red meat will include a variety of beef and pork luncheon meats with different methods of preservation. All foods will be provided to subjects during the intervention.
15869529|NCT03885531|Device|Total knee arthroplasty with Journey II CR Total Knee System|TKA with Journey II CR Total Knee System
15869530|NCT03885518|Other|Playground Stencils|The stencils (hopscotch, agility trail, foursquare, bullseye, etc.) will be painted on the playgrounds at each childcare center. A toolkit and training video will be distributed to staff at each center to aid in instructing the children on how to perform the tasks.
15869531|NCT03885479|Diagnostic Test|ELISA for the semi-quantitative analysis of serum food-specific IgGs against food-derived antigens|An enzyme-linked immunosorbent assay (ELISA) for the semi-quantitative analysis of serum food-specific IgGs against 7 food-derived antigens (Wheat, rice, beans, cow milk, eggs, chicken and beef)
15869532|NCT03885466|Behavioral|Nordic Walking exercise|Participants will initially train 3 times per week for 3 months. Training sessions will be led by trained peer- and/or student-instructors. Nordic walking sessions (starting at 20 and progressing to 60min/session) will include a warm-up, strengthening, and dynamic balance and stretching exercises in addition to Nordic walking, as per the Saskatoon Health Region guide (Saskatoon Health Region, 2014). Training (distance and intensity) will be progressive and individually set.
15869533|NCT03885440|Other|Age|Age<40 years old is chosen as the cutoff value.
15869534|NCT03885440|Other|OSA|The diagnosis of OSA (obstructive sleep apnea) relies on polysomnographic data showing an apnea-hypopnea index at least 5/hr with compatible symptoms.
15869535|NCT03885427|Drug|Ketamine|evaluate sedative, and analgesic effects of oral or nebulized ketamine
15869536|NCT03885414|Behavioral|In-session Virtual Reality exposure therapy|A series of exposure exercises (speech exercises) in front of a virtual audience, focusing on promoting inhibitory learning, with audio-feedback.
15869537|NCT03885414|Behavioral|Internet-administered transition program|Four-module internet program with weekly therapist guidance, focusing on transitioning to in-vivo exposure in everyday settings.
15869538|NCT03885401|Behavioral|Enhanced care planning|The intervention includes (1) screening for unhealthy behaviors, mental health needs, and social needs, (2) creation of a care plan, (3) quarterly updates to the plan, (4) a clinical navigator and community health worker to support accomplishing the care plan, (5) registry of community resources and programs, and (6) messaging and video-visit system for team members.
15869539|NCT03885388|Drug|MTX|multicourse methotrexate chemotherapy
15869540|NCT03885388|Drug|MTX+ACTD|combination use of methotrexate and actinomycin
15869541|NCT03885362|Device|Dexcom G6 and Abbott Freestyle Libre|Dexcom G6 - continuous glucose monitoring device - blinded. CE mark 2018 Abbott Freestyle Libre - flash glucose monitoring device. CE mark 2014
15869571|NCT03885102|Behavioral|Intradialytic exercise intervention|50% aerobic exercise, 50% resistance training thrice a week for 60 min per dialysis session, and health literacy counselling
15869572|NCT03885102|Behavioral|Usual Care|Usual care with no exercise intervention or health literacy counselling
15869650|NCT03884374|Behavioral|Standard Breathing and Attention Training (BAT)|Standard BAT intervention will incorporate most of the general aspects of the Focused BAT intervention but without the specific instructions related to mindfully attending to the breath in a non-evaluative manner.
15869651|NCT03884374|Device|Transcranial Direct Current Stimulation (tDCS)|A Soterix 1x1 Clinical Trials Direct Current Stimulator will apply 20 minutes of 2.0mA direct current through two bicarbon rubber electrodes encased in saline-soaked sponges
15869542|NCT03885349|Behavioral|SBIP+ ADAPs-IMP|Standard batterer intervention program plus Individualized Motivational Plans adapted to alcohol and/or drug abuse problems. The SBIP consist of 70 hr of a cognitive-behavioral intervention including discussion topics such as sexism, sex roles, and gender equality. The intervention phase consisted of six modules in which different intervention techniques were applied (i.e., group dynamics, roleplaying, videos, training in cognitive restructuring, emotion management skills). The IMP included a set of motivational strategies to increase treatment compliance and motivation for change and had four main strategies: (a) five individual motivational interviews, to identify IPV related personal goals and follow up their achievement (in this case, one of the goals has to be related to ADAPs); (b) three group sessions where participants share their goals; (c) therapists follow-up and reinforcement of participants' goals; and (d) use of retention techniques.
15869543|NCT03885349|Behavioral|SBIP+IMP|Standard batterer intervention program plus Individualized Motivational Plans. The SBIP consist of 70 hr of a cognitive-behavioral intervention including discussion topics such as sexism, sex roles, and gender equality. The intervention phase consist of six modules in which different intervention techniques are applied (i.e., group dynamics, roleplaying, videos, training in cognitive restructuring, emotion management skills). The IMP include a set of motivational strategies to increase treatment compliance and motivation for change and has four main strategies: (a) five individual motivational interviews, to identify IPV related personal goals and follow up their achievement; (b) three group sessions where participants share their goals, explain their progress to the group, and receive feedback, support and advice from the group; (c) therapists follow-up and reinforcement of participants' goals; and (d) use of retention techniques.
15869544|NCT03885336|Other|No Interventions|There are no interventions in this study. Participants are observed.
15869545|NCT03885323|Device|RF utilizing powered toothbrush|RF utilizing Powered toothbrush
15869546|NCT03885323|Device|Control placebo with no RF|Placebo control, with no RF
15869547|NCT03885310|Device|GIE Drug Coated Balloon|The GIE DCB is a balloon catheter with a 3 stage inflatable balloon coated with a proprietary coating containing the drug and carriers.
15869548|NCT03885297|Drug|Saxenda|Obesity pharmacotherapy
15869549|NCT03885297|Other|Lifestyle modification|Tier 3 NHS weight management
15869550|NCT03885297|Diagnostic Test|Metabolomics|Small molecule intermediates and products of metabolism
15869551|NCT03885297|Diagnostic Test|miRNA|Small non-coding RNA molecules
15869552|NCT03885284|Drug|mFOLFIRINOX|"Chemotherapy will consist of mFOLFIRINOX in 14-day cycles x 12 as used in the PRODIGE 24 study:
~Irinotecan 150 mg/m2 IV day 1
~Oxaliplatin 85 mg/m2 IV day 1
~Leucovorin 400 mg/m2 IV day 1
~5-fluorouracil 2,400 mg/m2 IV days 1-3 (no bolus)
~Pegfilgrastim 6 mg SC on-body injector day 3 (optional, up to investigator's discretion, can alternatively do day 4 without on-body injector)
~Suggested supportive care medications: fosaprepitant 150 mg IV day 1, dexamethasone 12 mg IV day 1, ondansetron 16 mg IV day 1, dexamethasone 4 mg PO q AM days 2-3, ondansetron 8 mg PO BID days 2-3."
15869553|NCT03885284|Radiation|Proton beam radiation|Proton beam radiation will consist of 5 daily doses of 5 GyE total, ideally administered Monday through Friday but can be administered within 7 business days, between cycles 6 and 7
15869554|NCT03885271|Other|Hall Technique|The Hall technique is a simplified method of utilizing stainless steel crowns in treatment of carious primary molars. The SSC is cemented onto the carious tooth using glass ionomer cement. Since there is no need for carious lesion removal, the use of local anesthesia is not mandate
15869555|NCT03885271|Other|Formecresol Pulpotomy|Pulpotomy is a procedure in which the coronal pulp is amputated, and the remaining radicular pulp tissue is treated with a medicament to preserve the pulp's health .This technique involves administration of local analgesia, Isolation of the tooth with rubber dam, Complete caries removal and then access to the pulp chamber using drills
15869556|NCT03885258|Drug|Melatonin Replacement Therapy|Melatonin (Aché Pharmaceutics, Brazil), 3 mg, administered in the evening, 30 minutes before the usual bedtime, every day for 3 months. After discontinuation of melatonin therapy, patients are followed up for 6 months to assess safety parameters and cardiac autonomic activity.
15869557|NCT03885245|Drug|L-ctirulline|7 weeks of treatment with 15 g/day of orally administered (powder form mixed with water) L-citrulline
15869558|NCT03885245|Drug|Matching Placebo|7 weeks of treatment with orally administered matching placebo (to 15 g/day of L-citrulline)
15869559|NCT03885232|Behavioral|Experimental: PIVOT with MI|Providers in participating intervention clinics will be trained in the PIVOT-MI strategy in which a presumptive format is used to initiate the childhood vaccine recommendation with all parents followed by use of motivational interviewing (MI) with parents who voice resistance to that recommendation. Parent participants will receive PIVOT-MI.
15869560|NCT03885232|Other|Active Comparator: Control|Providers at participating control clinics will deliver care as usual. Parent participants will receive standard care.
15869561|NCT03885219|Drug|Nab-paclitaxel and S-1|Nab-paclitaxel: 120 mg/m2 d1, 8, S-1:Body surface area < 1.25 m2, 80 mg/d; Body surface area ≥ 1.25 m2 , < 1.5 m2, 100 mg/d; Body surface area ≥1.5 m2, 120 mg/d; Bid, d1-14; repeat every 21 days.
15869562|NCT03885206|Other|Level of healthcare services|Patiens judged to be eligible for admittance to a municipal acute care wrad will be admitted to hospital as an intervnetion, to be able to compare same patient groups.
15869563|NCT03885180|Drug|Warfarin Sodium|Extending warfarin anticoagulation
15869564|NCT03885167|Other|Specimen Collection|No interventions take place as part of study participation- only specimen collection occurs for both cohorts.
15869565|NCT03885154|Drug|Valproic Acid (VPA)|IV VPA load 20mg/kg, followed by continuous infusion of 1mg/kg/hr for 24 hours
15869566|NCT03885154|Drug|Dihydroergotamine (DHE)|0 hour: 0.50 x (wt in kg) x (0.014) =Xmg 8 hour: 0.75 x (wt in kg) x (0.014) =Xmg 24 hour: 1.00 x (wt in kg) x (0.014) =Xmg
15869567|NCT03885141|Drug|Zolpidem|Zolpidem or Placebo if there is a wake up during the night
15869568|NCT03885128|Device|High frequency extra thoracic oscillations vest|Oscillations applied extra thoracic through vest device aiming for airway clearance
15869569|NCT03885128|Device|Intrathoracic oscillatory quake|Oscillation introduced intrathoracic through quake device through placing quake in mouth and ordering patient to breathing to move secretions
15869570|NCT03885115|Behavioral|Intervention|Involves 12-weeks of education related to healthy behaviors, nutrition, and exercise from certified fitness instructors.
15869688|NCT03883984|Drug|Cysteamine Bitartrate|Cysteamine bitartrate administered four times per day (QID) for 8 weeks. 125mg tablet QID.
15869573|NCT03885089|Drug|Infliximab [infliximab biosimilar 3]|<Psoriasis> The usual dose is 5 mg as Infliximab (Genetical Recombination) [Infliximab Biosimilar 3] for every kg of body weight given as an intravenous infusion. After an initial dose is given, the subsequent doses are given at Weeks 2 and 6, and every 8 weeks thereafter. After a dose at Week 6 is given, the dose may be increased or the dosing interval may be reduced for patients who have an incomplete response or reduced effects. These adjustments should be made in a stepwise manner according to condition of patients. The maximum dose is 10 mg for every kg of body weight at the dosing interval of 8 weeks and 6 mg for every kg of body weight at a reduced dosing interval. The minimum dosing interval is 4 weeks.
15869574|NCT03885076|Procedure|Blood collection and bone marrow aspirate|Blood and bone marrow samples will be collected for the trial alongside routine tests.
15869575|NCT03885063|Behavioral|Benjamin Rose Institute Care Consultation (BRI-CC)|The BRI-CC is a telephone-based intervention designed for adults with chronic conditions and has been used in persons with dementia and their caregiver (CG). This assessment is guided by the use of assessment tools with domains that trigger specific and pertinent needs of the dyad such as relationship strain, depression, financial concerns, memory problems, and difficult behaviors. To address unmet needs, the care consultant and dyad develop action plans with specific action steps pertinent to the dyad. The intervention involves maintenance and support where the care consultant (CC) continues the relationship with the dyad through regular telephone contact, email and mail. CC use a web-based reporting system, to maintain and track dyad information, assessments, action plans, completed tasks, and ongoing contacts. At a minimum, the care consultant will contact the dyad by telephone once per month over the duration of the study period (i.e. 6 months).
15869576|NCT03885050|Other|Ross score|modified score used for evaluation of heart failure in children, as a diagnostic tool for severity of heart failure
15869578|NCT03885024|Other|Retention Video|Participants assigned to the retention training arm will watch a brief training video that will include information on how to retain peers in clinical trials.
15869579|NCT03885011|Drug|CSF-1|This treatment arm consists of 2 different concentrations of CSF-1. Subjects randomized to the CSF-1 treatment arm will receive their first dose of CSF-1 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 arm will now receive a different concentration of CSF-1. Subjects will continue dosing twice a day in both eyes for approximately 1 week.
15869580|NCT03885011|Drug|CSF-1 Component #1|"This treatment arm consists of 2 different concentrations of CSF-1 Component #1.
~Subjects randomized to the CSF-1 Component #1 treatment arm will receive their first dose of CSF-1 Component #1 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 Component #1 arm will now receive a different concentration of CSF-1 Component #1. Subjects will continue dosing twice a day in both eyes for approximately 1 week."
15869581|NCT03885011|Drug|CSF-1 Component #2|This treatment arm consists of a single concentration of CSF-1 Component #2. Subjects randomized to the CSF-1 Component #2 treatment arm will receive their first dose of CSF-1 Component #2 in-office at Visit 2. All subjects will dose twice a day in both eyes with a single drop for approximately 1 week. At Visit 3, subjects randomized to the CSF-1 Component #2 arm will continue dosing with the same concentration of CSF-1 Component #2. Subjects will continue dosing twice a day in both eyes for approximately 1 week.
15869582|NCT03884998|Drug|Copanlisib|Given IV
15869583|NCT03884998|Biological|Nivolumab|Given IV
15869584|NCT03884985|Other|Visual stimulation|In the experiments, participants will sit in front of a computer monitor located a less than a meter of distance and will analyze the content of images extracted from collections of natural and computer-generated scenes. Subjects will be asked to report verbally or by pressing keys on a keyboard on image characteristics such as the locations of the objects present in the scenes, their number and/or their identities. Some experiments will involve a search paradigm in which subjects will have to report on the location and/or fine characteristics of a target element among a field of distracting similar elements, and/or visual discrimination tasks. The duration of the interval of time in which the image is maintained on the screen may be varied between few tens of milliseconds to several seconds. In a set of experiments, the eye movements performed by the subjects during the execution of the visual tasks will be recorded as explained below.
15869585|NCT03884972|Drug|Trabectedin|Given IV
15869586|NCT03884972|Drug|Venetoclax|Given PO
15869587|NCT03884959|Biological|HepaStem Infusion|HepaStem will be infused intravenously into the portal vein, either (1) via a permanent mesenteric PAC inserted surgically in an affluent of the portal vein; or (2) through a transient percutaneous transhepatic catheter inserted in to the portal vein under radio guidance.
15869588|NCT03884946|Other|Getting Off App|"A mobile phone application based on the Getting Off methamphetamine treatment manual. Participants download the app and progress through the sessions of the Getting Off intervention through the administration of games, activities, lessons, quizzes, and tutorials. There are 24 sessions total in the app, each addressing a different component of the methamphetamine treatment process. The fundamental basis of the app is gay-specific cognitive behavioral therapy, with elements of motivational interviewing, social support theory, and health belief model dynamics included."
15869615|NCT03884712|Device|CalmiGo|The CalmiGo handheld device is a device of similar size to an inhaler that uses guided breathing, aromatherapy and grounding techniques to regulate breathing to bring users a sense of calm and relaxation. The CalmiGo handheld device is being tested in this study to alleviate participants' anxiety and panic attack symptoms.
15869652|NCT03884374|Device|Sham Transcranial Direct Current Stimulation (tDCS)|Sham stimulation procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of 2 mA (30s ramp up/down) of stimulation at the beginning of the session.
15882894|NCT03782571|Device|etafilcon a Test 1|1-DAY ACUVUE® MOIST
15869589|NCT03884933|Other|Mobile team community mental health services|The intervention focuses on changing mental health care systems to be able to provide community-based mental health care for people with severe mental illness. This will be done through the development and implementation of multidisciplinary community mental health teams (CMHTs) in each of the implementation sites, consisting of at least one nurse, psychiatrist, psychologist, social worker, and peer worker (person with lived experience of a severe mental illness). The structure and delivery method of the community mental health teams is part of an evidence-based service delivery model providing flexible, assertive community mental health teams providing integrated services to people with severe mental illness (SMI) in order to structurally attain their recovery goals, as well as timely and appropriate care in the event of a crisis.
15869590|NCT03884920|Dietary Supplement|Polyherbal formulation|Test candidate will be administered per oral before / with meal in two divided doses
15869591|NCT03884907|Procedure|The patients will receive human bone graft screws surgically|All patients undergo Hallux valgus correction according to the Austin procedure using human bone graft screws.
15869592|NCT03884894|Diagnostic Test|molecular assay|performed with blood culture simultaneously
15869593|NCT03884894|Diagnostic Test|Blood culture|performed with molecular assay simultaneously
15869594|NCT03884881|Diagnostic Test|metagenomic next generation sequencing|Pathogens in the NGS group will be tested by NGS，then according the NGS results, adjust antibiotics
15869595|NCT03884881|Diagnostic Test|Conventional pathogen detection|Morphological detection, microbial culture, nucleic acid amplification technology, serological pathogen antibody titer detection and specific pathogen PCR detection. Then, according to the pathogen results, adjust antibiotics
15869596|NCT03884881|Drug|Meropenem，Imipenem，Caspofene，Osstat|Meropenem，Imipenem，Caspofene，Osstat
15869597|NCT03884868|Other|Iconographies to communicate risks|Use of iconographies to communicate the risks of the different possible diagnosis after a positive FIT during the screening program nurse visit.
15869598|NCT03884855|Other|Classical Cardiac Rehabilitation|Patients benefit from classical cardiac rehabilitation during 3 months.
15869599|NCT03884855|Other|Karate rehabilitation|Patients benefit from cardiac rehabilitation with traditional karate during 3 months. Patients will have four 60-minute group sessions four times a week, during which they will have 45-minute individual exercises and 15-minute pairs of exercises. The course of the sessions has been protocolised.
15869600|NCT03884842|Biological|Dupilumab/Dupixent|a monoclonal antibody designed for the treatment asthma and atopic dermatitis.
15869601|NCT03884842|Biological|Placebo|Matched placebo
15869602|NCT03884829|Drug|CYC140|CYC140 single agent
15869603|NCT03884816|Other|Determine the Incidence and Retention Rate|Determine the incidence of HIV and the retention rate of MSM/TGW/TGM/Intersex at risk for HIV infection
15869604|NCT03884803|Behavioral|E-health website|Access to the e-health intervention (website)
15869605|NCT03884803|Other|Standard Care|Control group to continue with standard care
15869606|NCT03884790|Device|surgical repair of long bone defects|"Current treatment of bone defects usually implies the use of bone grafts and/or biocompatible materials, to create a scaffold that bridges the defect, favoring the migration of cells from the neighboring tissues to fill the gap. Autograft and Allograft are the treatments most currently used for large bone loss, but both treatments have significant disadvantages. Different types of synthetic materials have been tested for repair of long bone gaps.
~However, at the moment, there is not any bone substitute with the ideal/desirable osteoinductive, osteoconductive and mechanical properties. GreenBone Implant is a synthetic, acellular, reabsorbable, new generation bone graft, being suitable for surgical reconstruction of bone defects."
15869607|NCT03884764|Procedure|pulsed radiofrequency|patients with chronic pelvic pain due to chronic prostatitis will receive pulsed radiofrequency on sacral root number 3 and ganglion impar denervation and the patients will be followed for 6 months to assess pain severity radiofrequency procedure: patients will positioned prone on the operating table and under x-ray guidence sacral foramen number 3 will be identified and through it radiofrequency needle will be advanced to target the sacral root ganglion impar procedure: under x-ray guidance the sacrococcygeal junction is identified and spinal needle will be introduced through it to target ganglion impar and 4 ml of alcohol 50% will be injected
15869608|NCT03884764|Procedure|ganglion impar denervation|patients with chronic pelvic pain due to chronic prostatitis will receive ganglion impar denervationand and the patients will be followed for 6 months to assess pain severity ganglion impar procedure: under x-ray guidance the sacrococcygeal junction is identified and spinal needle will be introduced through it to target ganglion impar and 4 ml of alcohol 50% will be injected
15869609|NCT03884751|Biological|CAR-GPC3 T Cells|CAR-GPC3 T Cells injection
15869610|NCT03884738|Other|Concentric Exercise|"Leg Curl Machine: 1st week - 1st day is 10 maximum repeat test. 2nd week - 2 days of training - 2 sets of 6 repeats. %60 percent of maximum load.
~3rd week - 3 days of training - 3 sets of 6-8 repeats. %60-80 of maximum load. 4th-8th week - 3 days of training - 3 sets of 8-12 repeats. when 3 sets of 12 achieved, load was increased with 2.5kg."
15869611|NCT03884738|Other|Nordic Eccentric exercise|"st week - 1 day - 2 sets of 5 repeats.
~nd week - 2 days - 2 sets of 6 repeats.
~rd week - 3 days - 3 sets of 6-8 repeats.
~th week - 3 days - 3 sets of 8-10 repeats. 5-8th weeks - 3 days - 3 sets of 12-8 repeats. When achieved 3 sets of 12 repeats with full range, speed was increased."
15869612|NCT03884738|Other|Neuromuscular Electrical Stimulation|8 weeks, three times per week, 15 minutes of bilateral hamstring stimulation. 100 Hz. frequency, 600 microsecond duration rectangular current
15869613|NCT03884725|Drug|Fibrinogen Concentrate|Fibrinogen Concentrate is to be administered as an intravenous infusion after discontinuation of cardiopulmonary bypass and administration of protamine. Subjects are to be given Fibrinogen Concentrate at an individually determined dose based on FIBTEM MCF and body weight as follows: (15 [mm] - MCF [mm]) * body weight [kg] / 140 [mm*kg/g] = gram fibrinogen to be dosed as Fibrinogen Concentrate. Fibrinogen Concentrate is to be infused over 1 to 2 minutes. After Fibrinogen Concentrate infusion, bleeding treatment will follow the predefined, standardized treatment regimen.
15869614|NCT03884725|Other|control|0.9% saline is to be administered as an intravenous infusion after discontinuation of cardiopulmonary bypass and administration of protamine. Patients randomized to the control group will receive the infusion of 0.9% saline (SF0,9%) prepared based on ROTEM measurement of maximum clot firmness (MCF). 0.9% saline is to be infused over 1 to 2 minutes. After 0.9% saline infusion, bleeding treatment will follow the predefined, standardized treatment regimen.
15869616|NCT03884699|Procedure|Accuracy of planned transverse Maxillary distance using Mimics software after fixation using Patient specific implant|"Virtual planning: based on clinical evaluation and 3D cephalometric analysis. Virtual osteotomies mimicking segmental Lefort I and a bilateral sagittal split osteotomy.
~Designing the virtual cutting guide. Virtual movement into the desired positions of the segmented maxilla and mandible, based on: clinical evaluation, 3D cephalometric analysis and the desired occlusion.
~Once the optimal position of the maxilla is achieved, a patient specific implant will be virtually designed to fix the segmented maxilla in its new position.
~Fabrication of the cutting guide using additive manufacturing technique from polymer material.
~Fabrication of PSI from titanium alloy using additive manufacturing technique."
15869617|NCT03884686|Other|Web-based education resource|Intervention includes fact sheets, question and answers, short videos featuring patients and/or clinicians.
15869618|NCT03884673|Drug|DTG+ 3TC|It is a simplified therapy regimen study of dolutegravir combined with lamivudine for HIV-1 infected patients in the real world of China.
15869619|NCT03884660|Device|remede System|Patients undergoing a remede System implant attempt. Study devices will be used per approved indications for use for each geography.
15869620|NCT03884647|Device|DELPhI (software as a medical device)|DELPhI software is acquiring and analyzing the TMS evoked response recorded with the EEG.
15869621|NCT03884634|Device|Dabir Micropressure Overlay|"The study intervention is the use of the Dabir micropressure overlay on the operating room table during surgical operations. The device is positioned on top of a standard foam pad and gel heat exchanger. The overlay is already in use in some (but not all) adult cardiac operating rooms.
~The overlay will be present on the operating room table for all adult cardiac operations. On odd calendar dates the device will be powered on, and on even calendar dates the device will be powered off."
15869622|NCT03884621|Other|EHP Group|The Enhanced post-discharge home-based care program (EHP) plus usual care
15869623|NCT03884595|Diagnostic Test|IG, IPF, NRBC, CRP, PCT, presepsin|Assessment of blood cell count parameters and inflammation markers - IG, IPF, NRBC, CRP, PCT, presepsin according to study group.
15869624|NCT03884582|Device|Cova Monitoring System 3|Healthy Volunteers
15869625|NCT03884556|Drug|TTX-030|Variable dose and schedule
15869626|NCT03884556|Drug|Pembrolizumab|Dose and schedule per standard of care
15869627|NCT03884556|Drug|Docetaxel|Dose and schedule per standard of care
15869628|NCT03884556|Drug|Gemcitabine|Dose and schedule per standard of care
15869629|NCT03884556|Drug|nab paclitaxel|Dose and schedule per standard of care
15869630|NCT03884543|Procedure|Individualized high PEEP strategy|Patients are randomized and intra-operatively ventilated with an individualized high PEEP strategy (Highest PEEP with the lowest driving pressure with recruitment maneuvers)
15869631|NCT03884530|Drug|Ticagrelor (Brilique) 90|Drug name Brilique 90 ml Drug form tablet
15869632|NCT03884530|Drug|Aspirin 75mg|Drug name Aspirin 75 ml Drug form tablet
15869633|NCT03884517|Drug|BAT8003|Phase 1 dose titration study from BAT8003 0.2mg/kg to 10mg/kg, then choose a proper dose for amplification study based on DLT result
15869634|NCT03884504|Device|Ventricular Assist Device System|Ventricular Assist Device System
15869635|NCT03884491|Drug|Vortioxetine IV|an intravenous (IV) 10 mg dose (1 mg/mL) of vortioxetine infused over 2 hours
15869636|NCT03884491|Drug|Vortioxetine SLA|5-25 mg of sublingual formulation A of vortioxetine
15869637|NCT03884491|Drug|Vortioxetine SLB|5-25 mg of sublingual formulation B of vortioxetine
15869638|NCT03884491|Drug|Vortioxetine SLC|formulation SLC: solution of vortioxetine, concentrate (12.5 mg/mL-62,5 mg/mL) 200 uL or 400 uL, SL, 5-25 mg
15869639|NCT03884478|Behavioral|Personalized Normative Feedback|Personalized Normative Feedback (PNF) is a popular social norms-based intervention strategy which presents individuals with a personalized, individual report designed to correct misperceived peer norms using a graphical display. Bar charts compare actual alcohol use statistics for the peer group to A) participants' estimates of peer drinking and, B) their own self-reported drinking.
15869640|NCT03884465|Drug|Inhaled dry powder treprostinil (LIQ861)|Inhaled dry powder treprostinil (LIQ861) at 25μg, 50μg, 75μg, or 100μg capsule strengths. Single dose in the acute setting. QID in the chronic setting.
15869641|NCT03884452|Drug|Atorvastatin|Tablets taken orally once daily in the morning
15869642|NCT03884452|Drug|Simvastatin|Tablets taken orally once daily in the morning or evening
15869643|NCT03884452|Drug|Ezetimibe|Tablet taken orally once daily in the morning or evening
15869644|NCT03884452|Drug|Placebo for Ezetimibe|Tablets taken orally once daily in the morning or evening
15869645|NCT03884439|Drug|Infliximab [infliximab biosimilar 3]|<Crohn's disease> The usual dose is 5 mg as Infliximab [Infliximab Biosimilar 3] for every kg of body weight given as an intravenous infusion. After an initial dose is given, the subsequent doses are given at Weeks 2 and 6, and every 8 weeks thereafter. After a dose at Week 6 is given, the dose may be increased or the dosing interval may be reduced for patients who have reduced effects. At an increased dose, the dose may be adjusted to 10 mg for every kg of body weight. At a reduced dosing interval, the dose of 5 mg for every kg of body weight may be given at the minimum dosing interval of 4 weeks. <Ulcerative colitis> The usual dose is 5 mg as Infliximab [Infliximab Biosimilar 3] for every kg of body weight given as an intravenous infusion. After an initial dose is given, the subsequent doses are given at Weeks 2 and 6, and every 8 weeks thereafter.
15869646|NCT03884413|Other|questionnaires|Longitudinal observational study. Collection of health data using self-administered questionnaires online.
15869647|NCT03884400|Procedure|Specimens obtained from surgical, phlebotomy or other non-invasive procedure|Biospecimen Collection
15869648|NCT03884387|Other|Patient Decision Aid|The Patient Decision aid used in this project is a tool designed to facilitate shared decision making in patients with lumbar herniated disk. It is intended to complement counseling with health professionals and help patients become involved in decision making by making explicit the decision that needs to be made, providing information about the advantages and disadvantages of having or not having surgery, knowledge of treatment outcomes, and by clarifying personal values.
15869649|NCT03884374|Behavioral|Focused Breathing and Attention Training (BAT)|Participants will receive mindfulness-based mental training regimen to independently practice mindfulness meditation.
15869685|NCT03884036|Biological|Vitamin D|Vitamine D
15869686|NCT03884010|Other|No intervention|Cross-sectional
15869687|NCT03883997|Other|No intervention|Cross-sectional
15869653|NCT03884361|Diagnostic Test|Vaginal Microbiome as result of aminocentesis|we will take a blood samples and a vaginale samples after and before the aminicentesis and check if the sample that we took after is different and contain microrganisms , if we find a different o we can say that as result of the Elective Amniocentesis
15869654|NCT03884348|Drug|proton pump inhibitor, amoxicillin, clarithromycin|non-resistant group with treatment of proton pump inhibitor, amoxicillin, clarithromycin
15869655|NCT03884348|Drug|proton pump inhibitor, amoxicillin, metronidazole|clarithromycin-resistant group with treatment of proton pump inhibitor, amoxicillin, metronidazole
15869656|NCT03884335|Procedure|laparoscopic radical prostatectomy|The surgery was carried out by laparoscopy. Intraoperative anesthetic maintenance was performed with TCI of propofol infusion for bispectral index between 40 and 60, restrictive administration of fluids or goal-directed parenteral fluid administration, normothermia, normotension and optimal intraoperative analgesia were maintained following the criteria of ERP. Afterwards, patients were awoken from general anaesthesia and transferred to the post-anaesthesia care unit (PACU) for a 6-hour follow-up prior to transfer to conventional ward.
15869657|NCT03884322|Other|Prepod|the prepod is either a 4 way stretch polyester blend fleece with 8 to 10% lycra, or a 95%cotton5% lycra blend knit. It comes in 4 different sizes to assure a pod that has a conforming but not restricting fit so that the infant is free to stretch in any direction at any time but is loosely held in a position of physiological flexion (the fetal position) when not stretching.
15869658|NCT03884322|Procedure|Joint compression exercises|Each premature infant enrolled as a control subject received approximately 10 minutes of joint compression exercises provided by a NICU trained physical or occupational therapist 5x a week. The exercises consisted of waking the infant slowly, gently if necessary just before feeding with a simple range of motion stretching program then stabilizing an extremity and applying force distally to proximally for 6 repetitions with a brief pause between each compression.
15869659|NCT03884309|Other|Experimental Hydrolyzed Protein Infant Formula|fed ad libitum
15869660|NCT03884296|Biological|FluMist|Quadrivalent, live, attenuated influenza vaccine, intranasal spray
15869661|NCT03884283|Device|FIBERGRAFT BG Matrix|Subjects who meet the criteria for entrance into the study will undergo posterolateral fusion using FIBERGRAFT® BG Matrix in combination with autograft and bone marrow aspirate (BMA)
15869662|NCT03884270|Behavioral|Hypnotherapy|7 sessions of self-administered gut-directed hypnotherapy for functional dyspepsia
15869663|NCT03884257|Device|Passeo-18 Lux treatment group|Percutaneous endovascular angioplasty with the Passeo-18 lux
15869664|NCT03884257|Device|IN.PACT Admiral treatment group|Percutaneous endovascular angioplasty with the IN.PACT Admiral
15869665|NCT03884244|Other|chewing gum|The group who take chewing gum after operation
15869666|NCT03884231|Procedure|MRI imaging procedure|MRI imaging procedure is performed in each subject with Infinity DBS
15869667|NCT03884218|Other|Infra red thermal imaging|thermal image using a non-touch, non-ionising, thermal camera system
15869668|NCT03884192|Drug|Consolidation Sintilimab|Sintilimab consolidation therapy after concurrent chemoradiation, 200mg IV, every 3 weeks, until progressive disease (PD, unless patients can continuously benefit from study treatment per investigators' judgement), start new anti-cancer therapy, intolerable toxicity, withdraw informed consent or other conditions that require study treatment discontinuation. Sintilimab will be given at a maximum of 12 months.
15869669|NCT03884166|Diagnostic Test|bronchoscopy|Patients will undergo bronchoscopy to sample respiratory tissue in different heights in order to analyze mucociliary clearance
15869670|NCT03884153|Device|CRP apheresis|"selective CRP apheresis by use of the PentraSorb-CRP"
15869671|NCT03884127|Drug|Ezetimibe 10mg|On the basis of the intervention of life style, drug intervention therapy was carried out for a period of 12 weeks
15869672|NCT03884127|Drug|Orlistat 120 MG|On the basis of the intervention of life style, drug intervention therapy was carried out for a period of 12 weeks
15869673|NCT03884114|Other|High-fidelity simulation|The first evaluation modality studied is high fidelity (HF) simulation. In our study, this modality is considered to be the gold-standard assessment method of clinical assessment, because HF simulation corresponds to the modality which reflects the best clinical competence in hospital settings. The HF pediatric manikin used (SimBaby), is able to reproduce all the signs of an asthma exacerbation (coughing, wheezing, tachypnea, chest indrawing, seesaw respiration, cyanosis). In the simulation room, participants can use the same items that those present in the simulation game (a glass of water, paracetamol, short acting beta-agonist, controller treatment (Fluticasone), an asthma spacer with a facial mask, saline nose drops to perform nasal irrigation, oral steroids in tablets (prednisone), and a phone).
15869674|NCT03884114|Other|Simulation game|"EfficAsthme is a simulation game used on a tablet computer. This simulation game was developed to train parents on the management of asthma exacerbations of their children. For the purpose of the study, EfficAsthme is diverted from its original use to assess students' clinical skills. The training scenario A polluted atmosphere is used in this study. Participants need to observe the signs presented by the child, and to determine the severity of the asthma exacerbation. From a menu on the right of the screen, the participant can choose several actions, especially to provide the short acting beta-agonist."
15869675|NCT03884114|Other|Multiple choice questionnaire|The third evaluation modality corresponds to a multiple choice questionnaire (MCQ) including 15 questions. As for HF-simulation and the simulation game, the MCQ starts with the same briefing and continues with 15 questions regarding the management of a moderate asthma exacerbation.
15869676|NCT03884101|Drug|Lenvatinib|Lenvatinib 4 mg or 10 mg capsules at a total daily dose of 20 mg taken by mouth once per day.
15869677|NCT03884101|Biological|Pembrolizumab|Pembrolizumab 200 mg IV infusion given on Day 1 of each cycle.
15869678|NCT03884101|Drug|Paclitaxel|Paclitaxel 175 mg/m^2 IV infusion given on Day 1 of each cycle.
15869679|NCT03884101|Drug|Carboplatin|Carboplatin 10 mg/mL IV infusion at a total dose of are-under-the-curve (AUC) 6 (per Calvert's formula) given on Day 1 of each cycle.
15869680|NCT03884088|Other|Limits of Stability|Balance analysis is assessment method to estimate fall of risk and deterioration of postural control.
15869681|NCT03884075|Drug|Semaglutide|Semaglutide injection once weekly
15869682|NCT03884062|Drug|DAAs|lab, U/S, Fibroscan & CT if needed
15869683|NCT03884049|Procedure|Embolization|transcatheter arterial embolization of neovessels around the knee
15869684|NCT03884049|Procedure|Sham embolization|Sham transcatheter arterial embolization of neovessels in the knee
15869690|NCT03883971|Other|3D printed model|Same as previously reported in arm descriptions
15869691|NCT03883971|Other|Placebo|nothing other than the ultrasound
15869692|NCT03883958|Procedure|Erector Spinae Plane Block|ESPB will be performed in sitting or lateral decubitus position. The target vertebral level will be correspond to the approximate mid-point of the extent of fractured ribs. The tip of the transverse process of the target vertebra will be identified using the high-frequency linear placed in cephalocaudal orientation about 3 cm to the spinous process. The skin and subcutaneous tissue will be infiltrated with 2-3 ml of 2% lignocaine. With the transducer fixed over the targeted TP, a 22-gauge 88-mm needle (Spinocan, B. Braun, Germany) will be advanced in-plane to the ultrasound beam in a cephalo-caudal direction to contact the TP. Correct needle tip position will be confirmed by doing alternating aspiration to confirm lack of inadvertent vascular puncture with injection of 1-2 ml of saline and visualizing linear fluid spread deep to erector spinae muscle, separating it from the TP. A bolus dose (2ml/segment) of plain bupivacaine 0.5% plus 4mg of Dexamethasone will be injected.
15869693|NCT03883958|Procedure|Paravertebral Block|TPVB will be performed at a spinal level midway between the uppermost and the lowest fractured rib with the patient in sitting or lateral decubitus position (with patients lying on their unaffected side). The ultrasound-guided technique will be used. A high-frequency linear transducer will be used to confirm the levels of the fractured ribs. The most cephalad and most caudad fractured ribs will be identified first. The fractured rib in the middle will be then identified, and the rib will be then traced back medially. After skin and subcutaneous tissue infiltration with 2-3 ml of 2% lignocaine, a 22-gauge 88-mm needle (Spinocan, B. Braun, Germany) will be inserted in a lateral-to-medial direction until the needle tip entered the paravertebral space. 1-2 ml of Saline will be injected into the paravertebral space while observing the pleura being moved deeply. A bolus dose (2ml/segment) of plain bupivacaine 0.5% plus 4mg of Dexamethasone will be injected.
15869694|NCT03883945|Drug|AIV001|intradermal injection
15869695|NCT03883945|Drug|Vehicle|intradermal injection
15869696|NCT03883932|Behavioral|Fatherhood Focused FVEP (F3)|F3 is designed to focus specifically on the importance of fathering within a cognitive-behavioral intervention.
15869697|NCT03883932|Behavioral|Family Violence Education Program (FVEP)|FVEP is a court-mandated program intended to treat those arrested for intimate partner violence (IPV).
15869698|NCT03883919|Drug|5-FU|-Standard of care drug
15869699|NCT03883919|Drug|Leucovorin|-Standard of care drug
15869700|NCT03883919|Drug|Liposomal Irinotecan|-Standard of care drug
15869701|NCT03883919|Drug|Paricalcitol|-Investigational drug
15869702|NCT03883919|Procedure|Serum and plasma blood samples|-baseline, day 1 of each cycle beginning with cycle 2
15869703|NCT03883919|Procedure|Tumor biopsy|"5 patients in each arm will be required to undergo a mandatory tumor biopsy from the primary pancreatic site or metastatic site, if safe and feasible, prior to cycle 1
~After Cycle 3 of treatment, all patients who had a baseline biopsy will be required to undergo a mandatory biopsy of the same site if safe and feasible."
15869704|NCT03883906|Biological|Viral Specific T-cells (VSTs)|VSTs will be infused into stem cell transplant recipients
15869705|NCT03883893|Drug|Intravenous acetaminophen|Intravenous acetaminophen will be given in the OR.
15869706|NCT03883893|Other|Normal saline|Normal saline will given if randomized to this group.
15869707|NCT03883880|Other|Epigallocatechin gallate|Colored solution prepared with epigallocatechin gallate to be consumed daily for two weeks during the epigallocatechin gallate intervention.
15869708|NCT03883880|Other|Epigallocatechin gallate control|Colored control solution to be consumed daily for two weeks during the epigallocatechin gallate intervention.
15869709|NCT03883880|Other|Linoleic acid|Colored emulsion prepared with linoleic acid to be consumed daily for two weeks during the linoleic acid intervention.
15869710|NCT03883880|Other|Linoleic acid control|Colored control solution to be consumed daily for two weeks during the linoleic acid intervention.
15869711|NCT03883880|Other|Capsaicin solution|Colored solution prepared with capsaicin to be consumed daily for two weeks during the capsaicin intervention.
15869712|NCT03883880|Other|Capsaicin control|Colored control solution to be consumed daily for two weeks during the capsaicin intervention.
15869713|NCT03883841|Drug|Iron Sucrose Solution for Injection|intravenous infusion of iron sucrose
15869714|NCT03883828|Drug|Chlorhexidine gluconate solution|Patients in the intervention arm will receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares and chlorhexidine wash to be used once daily to the body.
15869715|NCT03883828|Drug|Mupirocin Ointment|Patients in the intervention arm will receive a decolonization regimen, consisting of intranasal mupirocin ointment to be applied twice daily to the nares and chlorhexidine wash to be used once daily to the body.
15869716|NCT03883815|Other|Active Video Games Therapy|"Interventions were completed in 1-week periods, after 3 clinical visits. All individuals underwent both neurodevelopmental therapy and active video games therapy. Demographic data of individuals were recorded and muscle tone and gross motor functions were evaluated at the first visit. The games determined by the physiotherapist were explained and experienced by individuals. During the second visit, individuals played 4 games that were previously determined and experienced for about 45 minutes. On the last visit, individuals underwent neurodevelopmental therapy. During both treatment sessions, the accelerometer was fitted on a flexible belt by attaching it to the dominant wrist. Individuals were instructed not to remove the device during both treatment sessions.
~One session individuals treated with exercises which weight transfer and postural reactions were facilitated.
~Other session they played Nintendo Wii games in accordance with their current level and skills."
15869717|NCT03883802|Drug|Foxy-5|Lyophilized powder for solution for intravenous infusion
15869718|NCT03883802|Drug|FOLFOX regimen|6 months treatment regimen
15869719|NCT03883802|Procedure|Tumour resection (colon cancer surgery)|Surgical removal of patients colon cancer
15869720|NCT03883789|Diagnostic Test|FibroScan|FibroScan will be used to assess liver stiffness
15869721|NCT03883776|Drug|Al18F-NOTA-octreotide|One intravenous injection of 4 MBq/kg
15869751|NCT03883555|Device|High flow nasal therapy (HFNT) : Optiflow™|"HFNT will be administered through a heated humidifier (Airvo 2, Fisher and Paykel healthcare) and applied through large bore binasal prongs.
~Initial gas flow rate will be set at of 60 l/min and adjusted to 40-50 l/min based on patient's tolerance. FiO2 will be adjusted to maintain an SpO2 ≥ 92%. Initial temperature will be set at 37° and reduced according to patient's tolerance"
15869722|NCT03883776|Device|PET/CT|"Part 1: Healthy volunteers will undergo consecutive whole-body PET scans, including one low-dose CT, for the first 90 minutes. At 150 ± 15 min and 300 ± 30 min post injection two additional static whole-body PET/CT scans will be acquired.
~Part 2: Neuroendocrine tumor patients will undergo a dynamic PET scan for the first 45 minutes, followed by 3 static whole-body PET/CTs at 60 ± 10 min, 120 ± 30 min and 180 ± 30 min post injection."
15869723|NCT03883776|Other|Venous blood samples|Blood samples will be obtained for laboratory safety evaluation for initial screening and safety evaluation after injection. Furthermore, venous blood samples will be obtained for metabolite analysis and activity measurements (only for patients) at various time points post injection (5 ± 2 min, 10 ± 5 min, 20 ± 10 min, 40 ± 20 min, 60 ± 30 min, 120 ± 60 min).
15869724|NCT03883763|Drug|bupivacaine S75:R25 plus 8% glucose|Spinal anesthesia, 20 mg
15869725|NCT03883763|Drug|bupivacaine S50:R50 plus 8% glucose|Spinal anesthesia, 20 mg
15869726|NCT03883737|Other|PNM|an asymmetric rectangular biphasic current (250 microseconds, 10 Hz)
15869727|NCT03883724|Behavioral|Brief behavioral treatment of insomnia (BBTI)|The BBTI consists of a 45- to 60-minute individual intervention session followed by a 30-minute follow-up session 2 weeks later and 20-minute telephone calls after 1 and 3 weeks. The brief behavioral treatment component will focus on four behaviors that promote sleep through homeostatic, circadian, or association mechanisms. 50 These four interventions are simple to conceptualize and implement, and constitute the core of efficacious multi-modal behavioral treatments for insomnia.
15869728|NCT03883724|Behavioral|Information-only control (IC)|The IC condition is intended to emulate the behavioral treatment information generally to available patients. It includes instructions to review hand out on healthy sleep practices. We will also use patient education videos on insomnia developed locally and widely used in clinical research. The content of these videos overlap substantially with BBTI but without individualized behavioral instructions. Two weeks later, IC participants will receive a 10-minute follow-up telephone call to encourage continued participation. Participants will be referred to the brochures for specific sleep-related questions.
15869729|NCT03883711|Other|Database|Create a database containing clinical characteristic, clinical presentation, flow indexes and treatment of consecutive incident patients with ACS or myocardial injury.
15869730|NCT03883698|Drug|Sofosbuvir|Sofosbuvir is the backbone of the most of the currently used anti-HCV treatment regimens
15869731|NCT03883698|Drug|Daclatasvir 60 mg|Daclatasvir, in combination with sofosbuvir, is approved for the treatment of hepatitis C virus infection in absence of liver cirrhosis
15869732|NCT03883685|Dietary Supplement|Probiotane|probiotics capsules of blended strains including Lactobacillus acidophilus, L. casei and L. rhamnosus
15869733|NCT03883685|Dietary Supplement|Placebo|Placebo
15869734|NCT03883672|Behavioral|Personality and transactional factors|"Pre-admission transplant questionnaire: given and collected by the transplant physician during the pre-graft consultation before entering hospitalization (approximatively 15 days before). To be completed by the patient on site (approximately 45 minutes to complete the questionnaire)
~Transplant admission questionnaire: given during the first days of hospitalization. To be completed within 6 days and returned to the transplant physician (approximately 30 minutes to complete the questionnaire)
~Post-transplant follow-up questionnaire: given in consultation at 6 months by the transplant physician (between 30 and 45 minutes to complete the questionnaire in consultation)"
15869735|NCT03883659|Other|Smartphone|patients with frozen shoulder in the smartphone group will use the smartphone to conduct the home exercise program. The patients will be asked to follow the description to have mobility assessment at least 1 week and do the individualized exercise themselves.
15869736|NCT03883659|Other|traditional paper hangouts|patients with frozen shoulder in the smartphone group will use the paper hangouts to conduct the home exercise program. The content of the paper hangouts were description of the home exercise.
15869737|NCT03883646|Behavioral|Mindfulness|Mindfulness-based Relapse Prevention. Guided meditation/discussion (Group sessions).
15869738|NCT03883646|Behavioral|Relapse Prevention|Relapse Prevention. Cognitive behavioral principles/strategies (Group sessions).
15869739|NCT03883633|Behavioral|ReCODE Protocol|Functional medicine approach to address symptoms of Alzheimer's and cognitive decline
15869740|NCT03883620|Biological|Dengushield 1 mg/kg (Cohort 1) intravenous|Participants will be administered Dengushield 1 mg/kg as slow intravenous injection.
15869741|NCT03883620|Biological|Dengushield 3 mg/kg (Cohort 2) intravenous|Participants will be administered Dengushield 3 mg/kg as slow intravenous infusion.
15869742|NCT03883620|Biological|Placebo 3 mg/kg (Cohort 2) intravenous|Participants will be administered Placebo 3 mg/kg as slow intravenous infusion.
15869743|NCT03883620|Biological|Dengushield 7 mg/kg (Cohort 3) intravenous|Participants will be administered Dengushield 7 mg/kg as slow intravenous infusion.
15869744|NCT03883620|Biological|Placebo 7 mg/kg (Cohort 3) intravenous|Participants will be administered Placebo 7 mg/kg as slow intravenous infusion.
15869745|NCT03883620|Biological|Dengushield 12 mg/kg (Cohort 4) intravenous|Participants will be administered Dengushield 12 mg/kg as slow intravenous infusion.
15869746|NCT03883620|Biological|Placebo 12 mg/kg (Cohort 4) intravenous|Participants will be administered Placebo 12 mg/kg as slow intravenous infusion.
15869749|NCT03883594|Behavioral|Technology-assisted Stepped-care|Step 1 of the intervention includes educational materials related to asthma. Step 2 includes electronic monitoring of adherence and a text messaging intervention personally tailored to the participant. Step 3 includes problem solving telehealth sessions with a trained clinician.
15869750|NCT03883581|Drug|dextromethorphan HBr and quinidine sulfate|All eligible and enrolled study participants will be administered the study drug, Nuedexta, as recommended by their treating neurologists.The drug will be administered per the efficacy and safety protocol, with no changes in administration method or recommended dose for individuals with ALS. Prior to commencing treatment with Nuedexta, participants will undergo a comprehensive bulbar evaluation of swallowing, airway protection, speech functions, and complete validated patient-reported surveys. Following 30 days of Nuedexta treatment, participants will be e-evaluated using the same battery of assessments.
15869793|NCT03883269|Drug|70% topical ethanol solution|70% topical ethanol solution, BID, 4 weeks
15869752|NCT03883555|Device|Non invasive ventilation (niv)|"NIV will be delivered through a face mask connected to a dedicated ventilator with pressure support applied in a noninvasive ventilation mode (Monnal T75, Airliquide Medical Systems, Antony, France).
~The Pressure-support level will be adjusted to obtain an expired tidal volume of 6-8 ml/kg of predicted body weight and a respiratory rate of 25-30 b/min. PEEP (range 5-10 cm of water) and FiO2 will be adjusted to maintain an SpO2 ≥92% and to patient's comfort."
15869754|NCT03883529|Other|Writing about and reviewing birth experience|Writing about and reviewing birth experience with a known midwife from antenatal care about 6 weeks post-partum.
15869755|NCT03883516|Other|Pre-briefing with the current SE treatment guidelines|instruction of the study participants according to the evidence-based guideline for the treatment of SE published by the American Epilepsy Society prior to the simulation training
15869756|NCT03883516|Other|"Pre-briefing with a consolidated one page SE treatment guide"|"instruction of the study participants with a consolidated one page SE treatment guide prior to the simulation training"
15869757|NCT03883516|Other|No Pre-briefing|no instruction of the study participants prior to the simulation training
15869758|NCT03883503|Other|Beer 5%o|Weight adjusted beer to reach 0.8 blood alcohol content will be given over the time course of 1 hour to the participants
15869759|NCT03883503|Other|Beer 8.5%o and water|Weight adjusted beer to reach 0.8 blood alcohol content and water will be given over the time course of 1 hour to the participants
15869760|NCT03883503|Other|Beer 8.5%o and stock|Weight adjusted beer to reach 0.8 blood alcohol content and stock will be given over the time course of 1 hour to the participants
15869761|NCT03883503|Other|Water|Water equivalent to the calculated volume of beer will be given over the time course of 1 hour to the participants
15869762|NCT03883490|Diagnostic Test|ECG|A 12-lead ECG will be taken for each participant.
15869763|NCT03883490|Diagnostic Test|Blood test and biobanking|All patients will undergo venepuncture and blood sample will be taken for full blood count, renal function and plasma will be stored for future biomarker analysis.
15869764|NCT03883490|Diagnostic Test|Trans-thoracic Echocardiogram|A standard TTE will be undertaken to measure severity of AS as well as bi-ventricular function. Speckle-tracking data will be performed offline to assess diastolic function.
15869765|NCT03883490|Diagnostic Test|Vicorder recording|Measurement of carotid-femoral PWV will be made using the Vicorder technique.
15869766|NCT03883490|Diagnostic Test|Magnetic Resonance Imaging|Patients will undergo a stress MRI scan of their heart and aorta on a 3T scanner, including 4D flow.
15869767|NCT03883477|Device|Endoscopic Release|Retrograde endoscopic release of the A1 pulley for treatment of trigger finger will be performed using a commercially available device by A.M. Surgical, Inc. This device has been cleared for marketing, sale and use by the U.S. Food and Drug Administration (FDA) for use as an Orthopedic manual surgical instrument based on its similarity in structure and function to previously used devices.
15869768|NCT03883477|Procedure|Standard Open Release|Standard open surgical release of the A1 pulley for treatment of trigger finger.
15869769|NCT03883464|Other|Diet|Restriction in postoperative fat diet
15869770|NCT03883451|Other|Helmet Model|helmet model worn by football players
15869771|NCT03883438|Procedure|Modified coronally advanced flap and acellular dermal matrix graft|Evaluation of the effectiveness of vertical incisions in the management of multiple gingival recessions (Miller Class I&II ≥3 mm) treated with coronally advanced flap and acellular dermal matrix graft
15869772|NCT03883425|Other|interRAI-HC assessments|Standardized geriatric assessments done with the interRAI-HC instrument (Canadian French version 9.1) by trained nurses
15869773|NCT03883412|Other|Exercise|16 weeks of treatment
15869774|NCT03883412|Drug|Liraglutide|16 weeks of Liraglutide
15869775|NCT03883399|Other|Survey|Survey among colorectal surgeons
15869776|NCT03883386|Drug|Loratadine|10 mg in a capsule
15869777|NCT03883386|Drug|Placebo|Administered via capsule
15869778|NCT03883373|Procedure|alveolar bone graft with cancellous bone and a cortical block|alveolar bone graft with cancellous bone only
15869779|NCT03883373|Procedure|alveolar bone graft with cancellous bone only|alveolar bone graft with cancellous bone only
15869780|NCT03883360|Drug|Cannabidiol (CBD)|Participants receive a single dose of CBD (600 mg p.o.) per day for 12 weeks.
15869781|NCT03883360|Drug|Placebo|Participants receive a single daily dose of the oil vehicle used to dissolve CBD but without any active ingredient, in the same amount as the CBD group, for 12 weeks.
15869782|NCT03883347|Drug|Dexmedetomidine|Intravenous administration of dexmedetomidine 0.6 mcg / kg within 10 minutes prior to regional anesthesia and 0.6 mcg / kg / h after performing regional anaesthesia until the end of the surgery
15869783|NCT03883347|Drug|Remifentanil|Intravenous administration of remifentanil 1 mcg / kg within 10 minutes prior to regional anesthesia and 0.025 mcg / kg / h after performing regional anaesthesia until the end of the surgery
15869784|NCT03883334|Drug|Metisoprinol|Immunodulator
15869785|NCT03883321|Other|Cognitive behavioral stress management|Management of patients in 10 group sessions with cognitive and behavioral therapies associated with relaxation in order to learn how to manage stress
15869786|NCT03883308|Behavioral|Multi-domain cognitive training|The cognitive exercises are designed to train executive functions and memory.
15869787|NCT03883308|Behavioral|Cross-word puzzle training|The active control group will be asked to complete a variety of crossword puzzles using the same curriculum assigned to the TG group.
15869788|NCT03883295|Procedure|Control|The specimens will be root canal treated conventionally
15869789|NCT03883295|Procedure|NeoMTA Plus|The specimens will be subjected to vital pulp amputation using NeoMTA Plus.
15869790|NCT03883282|Other|Not Provided|Not Provided
15869791|NCT03883269|Drug|Erythromycin 4% topical gel formulation|Erythromycin 4% topical gel formulation, BID, 4 weeks
15869792|NCT03883269|Drug|Clindamycin 1% topical lotion formulation|Clindamycin 1% topical lotion formulation, BID, 4 weeks
15869794|NCT03883256|Device|high flow nasal cannula|High flow nasal cannula is a device that delivered heated and humidified high flow gases to at or near body temperature to avoid drying and possible injury to the nasal mucosa. In this study, subjects perform a constant-load exercise test with high flow nasal cannula.
15869795|NCT03883256|Device|nasal cannula|Nasal cannula is a device that delivered oxygen to patients. In this study, subjects perform a constant-load exercise test with nasal cannula.
15869796|NCT03883243|Device|Telecoaching|A telecoaching application linked to a step counter will be installed on a patients smartphone for 8 weeks. The application shows a daily goal (expressed as amount of steps per day) to the patient. This goal is weekly revised and patients themselves are able to increase the goal every week with 500 or 1000 steps/day. Every evening, they are able to check the daily feedback platform, which gives them insights in their physical activity pattern of the day and previous weeks. At a regular basis, 'tip of the day' messages appear as a pop-up, to keep patients motivated.
15869797|NCT03883230|Diagnostic Test|GLYWD|As mentioned in the group description, GLYWD is a plastic test tube and a chromatic test that contains two solutions. When combined with a wound exudate and incubated at RT, it will change colour to red if there is a pathological bacterial wound infection present.
15869798|NCT03883217|Device|PDVibe2|The PDVibe2 is owned by Resonate Forward, LLC and will be loaned to Virginia Commonwealth University (VCU) for this project. The device is non-invasive, lightweight, untethered, contains a rechargeable battery, and is worn on both feet and ankles. PDVibe2 delivers vibration when activated by an easy to access switch on the device or by remote. The internal circuitry has been miniaturized, is encased in a small box, and is attached to the ankle using a soft flexible band.
15869799|NCT03883204|Drug|Aripiprazole|Initial dose: 10 mg.
15869800|NCT03883204|Drug|Risperidone|Initial dose: 2 mg.
15869801|NCT03883191|Other|L. rhamnosus bv-77, B. animalis subsp. lactis CP-9 and L. salivarius AP-32 mix probiotics powder|Taking 1 pack of L. rhamnosus bv-77, B. animalis subsp. lactis CP-9 and L. salivarius AP-32 mix probiotics powder three times a day before meals for three months.
15869802|NCT03883191|Other|Placebo|Taking 1 pack of placebo powder three times a day before meals for three months.
15869803|NCT03883178|Procedure|Minimal-invasive endoscopic transgluteal approach|Every patient, suffering from a pudendopathie or clunealgie, conform the Nantes criteria, and who are candidates for a surgical treatment through the transgluteal open approach, will be asked their permission to perform the procedure through a minimal-invasive endoscopic transgluteal approach.
15869804|NCT03883165|Other|high-intensity neck strengthening|"All subjects will exercise 2 days per week for 12 weeks under the direct supervision of a study-assigned strength coach with a minimum of 1 day of rest between exercise sessions.
~Participants will perform a standardized set of general resistance exercises targeting the chest, shoulders, back, upper and lower extremities, and core. Additionally, they will also perform a higher number of repetitions of manual resistance neck strengthening exercises in sagittal plane flexion and extension, coronal plane lateral flexion in both directions, and axial plane rotation in both directions,as well as dumbbell shoulder shrugs."
15869805|NCT03883165|Other|low-intensity neck strengthening|All subjects will exercise 2 days per week for 12 weeks under the direct supervision of a study-assigned strength coach with a minimum of 1 day of rest between exercise sessions. Participants will perform a standardized set of general resistance exercises targeting the chest, shoulders, back, upper and lower extremities, and core. Additionally, they will also perform a lower number of repetitions of manual resistance neck strengthening exercises in sagittal plane flexion and extension, coronal plane lateral flexion in both directions, and axial plane rotation in both directions, as well as dumbbell shoulder shrugs.
15869806|NCT03883165|Other|Control group|"All subjects will exercise 2 days per week for 12 weeks under the direct supervision of a study-assigned strength coach with a minimum of 1 day of rest between exercise sessions.
~Participants will perform a standardized set of general resistance exercises targeting only the chest, shoulders, back, upper and lower extremities, and core, without resistance exercises specifically targeting the neck."
15869807|NCT03883139|Behavioral|JASPER|JASPER is a developmentally anchored behavioral intervention that assumes that communication develops from social interactions in which specific social engagement strategies, symbolic representations, and early communication forms are modeled and naturally reinforced by the adult's responses to the child.
15869808|NCT03883139|Behavioral|DTT (Discrete Trial Training)|"DTT is an adult-led, highly structured, behavioral teaching approach, is considered to have the strongest evidence as a standard of care for young children with autism. DTT emphasizes didactic, adult-led instruction."
15869809|NCT03883126|Behavioral|Contingency management|Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions and verified abstinence from alcohol.
15869810|NCT03883126|Behavioral|Contingency management|Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions only with no contingency on alcohol use.
15869811|NCT03883113|Biological|MVA-NP+M1|Trial Vaccine
15869812|NCT03883113|Biological|Saline|Sodium Chloride Placebo
15869813|NCT03883113|Biological|H3N2 (A/Belgium/2417/2015)|Challenge Agent
15869814|NCT03883100|Drug|HQP1351|40 mg tablet, taken orally once every other day
15869815|NCT03883087|Drug|HQP1351|40 mg tablet, taken orally once every other day of a 28-day cycle
15869816|NCT03883074|Device|hyaluronic acid with chondroitin + sulphate + magnesium trisilicate|Melt in mouth tablets (1100 mg)
15869817|NCT03883074|Device|Placebo|tablets with the same aspect of the active device
15869818|NCT03883061|Other|regular medical treatment|regular medical treatment
15869819|NCT03883048|Other|Observation of bronchiectasis with pulmonary hypertension|Interleukin 1 beta, IL - 18, endothelin 1 in peripheral blood and bronchoalveolar lavage from patients will be examined through enzyme linked immunosorbent assays (ELISA). NLRP3 inflammasome, ASC, Caspase 1 mRNA expression from peripheral blood mononuclear cells and mucous membrane of the bronchial lung tissues will be examined through RT-PCR method.
15869820|NCT03883035|Other|automatic quality-control system|Automatic quality-control system could real-time measuring endoscopic inspection completeness, detecting gastric neoplasms and evaluating gastric mucosal visibility.
15869821|NCT03883022|Drug|with U-VANCO (vancomycin hydrochloride)|1 gm or 2 gm mixed with autogenous cancellous bone graft
15869822|NCT03883022|Drug|without U-VANCO (vancomycin hydrochloride)|no vancomycin added
15869823|NCT03882996|Drug|Ezetimibe|Ezetimibe 10 mg daily in the morning
15869824|NCT03882996|Drug|Atorvastatin|Atorvastatin 10 mg daily in the morning. Atorvastatin dose could be titrated up (by doubling the dose up to a maximum of 80 mg daily) to achieve the target low-density-lipoprotein cholesterol (LDL-C) level of 100 mg/dL (2.59 mmol/L) after a minimum of 4 weeks of treatment.
15869825|NCT03882983|Drug|Antria Cell Preparation Process|"Biological/Vaccine: Stromal Vascular Fraction The SVF obtained from adipose tissue will be added to the graft
~Other Names:
~Stromal Vascular Fraction
~Adiployx Biological/Vaccine:"
15869826|NCT03882970|Drug|Tirzepatide|Administered SC
15869827|NCT03882970|Drug|Insulin Degludec|Administered SC
15869828|NCT03882957|Behavioral|Sustained attention|participants will complete a sustained attention task
15869829|NCT03882957|Behavioral|media multi-task|participants will complete multiple media tasks at the same time
15869830|NCT03882957|Other|Video|participants will watch a video of media tasks being completed
15869831|NCT03882931|Other|Theta Burst Transcranial Magnetic Stimulation|Theta Bursts are short bursts of stimulation at high frequencies, which are applied 5 times per second
15869832|NCT03882931|Other|Focused Ultrasound|Low intensity focused ultrasound is sound energy stimulation at a low intensity of 1-30 W/cm2
15869833|NCT03882931|Other|Sham|The investigators will simulate theta bursts pulses similar to the Theta Burst Transcranial Magnetic Stimulation groups but without stimulation.
15869834|NCT03882918|Drug|OV101|Each subject will be titrated to his or her maximal tolerated daily dose, up to a maximum daily dose of 15 mg at bedtime.
15869835|NCT03882905|Drug|Ezetimibe|10 mg tablet, oral, once daily
15869836|NCT03882905|Drug|Placebo|one tablet, oral, once daily
15869837|NCT03882905|Drug|Simivastatin|Once daily administration at dose to be determined
15869838|NCT03882905|Drug|Statin|Statin administered orally once daily at dose determined by treatment prior to enrollment by personal physician
15869839|NCT03882892|Drug|Ezetimibe|Ezetimibe 10 mg tablets
15869840|NCT03882892|Drug|Atovastatin|Atorvastatin 10, 20, and 40 mg tablets at a daily dose of 10 to 80 mg
15869841|NCT03882892|Drug|Placebo|Placebo tablets matched to ezetimibe
15869842|NCT03882879|Behavioral|Karate Classes|Eligible subjects will engage in twice-weekly karate classes for 6 months, specifically designed for individuals with early to middle stage PD, focused on incorporating upper and lower limb movements in multiple directions, increasing awareness throughout the body, shifting body weight and rotation, relaxation of the muscles, improving reaction time, using complex repetitive actions to improve coordination, footwork training and centered weight shifts to help with fall prevention, and striking shields for self-defense and stress relief
15869843|NCT03882879|Behavioral|Pre-Intervention Study Visit|At the pre-intervention study visit, the study logistics will be reviewed, informed consent process will occur, the subject will complete a battery of pre-intervention assessments focused on overall mobility, gait, balance, mood, cognition, and quality of life, and the subjects will be prompted to share their expectations of and goals for the karate classes.
15869844|NCT03882879|Behavioral|Bimonthly Online Survey|All participants in both arms will receive a personalized email every two months directing them to indicate how frequently they have attended karate classes, how frequently they have engaged in exercise, how frequently they have fallen, whether their PD medication regimen has changed, and they will complete brief surveys about mood, camaraderie, and overall quality of life.
15869845|NCT03882879|Behavioral|6-month Study Visit|All participants in both arms will complete questionnaires and assessments of their PD symptoms, cognition, mood, camaraderie, and quality of life. Subjects will meet with a member of the study team to complete a series of physical and cognitive assessments. At this visit, subjects will review the initial expectations they shared at the pre-intervention visit and indicate if they thought their goals were achieved for the class.
15869846|NCT03882879|Behavioral|12-month Study Visit|At the 12-month study visit, the assessments from the baseline and 6-month study visit will be readministered, along with an assessment of the subject's global impression of change. Subjects will be prompted to share their thoughts on how the intervention impacted their overall wellbeing, balance, and mindfulness; whether the intervention achieved their expectations; and they will be asked to provide feedback for improvements.
15869847|NCT03882866|Procedure|3D-printed non-coplanar template|3D-printed non-coplanar template is used in the intervention group. Iodine-125 seed implantation therapy is assisted using 3D-printed non-coplanar template as a guide in patients with locally advanced pancreatic cancer. 3D-printed non-coplanar template is designed and printed according to a preoperative CT scan and treatment planning system.
15869848|NCT03882866|Procedure|3D-printed coplanar template|3D-printed coplanar template is used in the intervention group. Iodine-125 seed implantation therapy is assisted using 3D-printed coplanar template as a guide in patients with locally advanced pancreatic cancer. 3D-printed coplanar template is designed and printed according to a preoperative CT scan and treatment planning system.
15869849|NCT03882853|Other|Conservative exercise group|The group will be thought exercise series which based on recommendations published on October 2016 by UK national osteoporosis foundation.Handouts including pictures and narrations of the exercises will be given to patients. Patients would be encouraged to perform the exercises 5 days a week. A diary will be given to note the days exercises completed.
15869850|NCT03882853|Other|Tree pose added exercise group|"The group will be thought exercise series which will be based on recommendations which is published on October 2016 by UK national osteoporosis foundation, also be taught tree pose of yoga. Handouts including pictures and narrations of the exercises will be given to patients. Patients would be encouraged to perform the exercises 5 days a week. A diary will be given to note the days exercises completed."
15869851|NCT03882840|Biological|NK cell therapy|Infusion of itNK cells
15869852|NCT03882814|Drug|pethidine|Pethidine 50 mg intramuscular (IM) injection was performed when cervical dilatation was at or greater than 4 cm and the cardiotocogram uterine contraction recordings of 200 Montevideo units was reached. Opioid analgesia (pethidine HCl - 50 mg I.M.) was given following amniotomy.
15869853|NCT03882814|Drug|Placebo - Concentrate|Intramuscular saline was administered to the control group as placebo. Salin intramuscular (IM) injection was performed when cervical dilatation was at or greater than 4 cm and the cardiotocogram uterine contraction recordings of 200 Montevideo units was reached. salon was given following amniotomy.
15869854|NCT03882801|Drug|Gefapixant|In Periods 1 and 2 (7 days each) participants receive 4 tablets (180 mg) of gefapixant (MK-7264) QHS.
15869855|NCT03882801|Drug|Placebo|In Periods 1 and 2 (7 days each) participants receive 4 tablets of placebo QHS.
15869856|NCT03882788|Drug|Isoflurane|Isoflurane (volatile anesthesia) will be delivered at 1.5-2.0%% as required for anesthetic management.
15869857|NCT03882788|Drug|Fentanyl|Fentanyl (narcotic anesthesia) maintenance will be with fentanyl 5 mcg/kg/hr not to exceed 10 mcg/kg/hr.
15869858|NCT03882775|Drug|Bivalirudin|Patients would be given anticoagulant therapy with bivalirudin in acute STEMI during emergency PCI operation.
15869859|NCT03882775|Drug|Heparin|heparin with or without gpi during emergency PCI.
15869860|NCT03882762|Drug|Cebranopadol 200 μg tablet|200 μg cebranopadol film-coated tablet was taken with 240 mL of water under fed conditions.
15869861|NCT03882736|Procedure|gluteal augmentation with flap in circumferential body lift|classic circumferential bodylift surgery, using two different well-known flaps for gluteal augmentation
15869862|NCT03882723|Device|Evaluated masks used for NIV with mechanical ventilators|Order of the masks were randomly chosen. Investigators randomly assigned all masks for paper raffling from container. All subjects performed 20 minutes on each mask followed by 5 minutes wash out interval between masks. EPAP levels will be 0, 2, 4, & 5 (5 minutes for each level) while IPAP remains at 5 higher than EPAP. FiCO2 and EtCO2 were collected at 4:00, 4:30 and 5:00 minute mark for each EPAP level. Also, subjective mask comfort was assessed via visual analog scale (VAS) with 1 referring to least comfortable and 5 being the most comfortable after 5 each EPAP setting.
15869863|NCT03882710|Drug|Metoprolol XR|Metoprolol XR capsule 25/50/100 mg once daily for 12 weeks
15869864|NCT03882684|Diagnostic Test|In-situ imprinting detection|The loss of imprinting (LOI) and copy number variation (CNV) from biopsies will be tested by LiSen in-situ imprinting detection.
15869865|NCT03882671|Device|EpiTel Epilog|EEG recording device
15869866|NCT03882671|Device|Empatica E4|PPG, sweat level, temperature and accelerometry recording device
15869867|NCT03882671|Device|GENEActiv|Temperature, light level and accelerometry recording device
15869868|NCT03882645|Other|CHH-diet|"This study took the DASH Diet as the basic model and developed the Chinese Heart Healthy Diet ( CHH-diet) according to the principles in the 2016 Dietary Guidelines for Chinese Residents. The nutrients targets in CHH-diet are set as following: fat % of total kcal: 25-27% (saturated: 6%; monounsaturated: 12%; polyunsaturated: 8%); carbohydrate % of total kcal: 55-60%; protein % of total kcal: 17-19%; dietary fiber: 30 g/day; sodium: 3000 mg/day; potassium: 3700 mg/day; magnesium: 500 mg/day; calcium: 1200 mg/day. The total energy will be set according to how much participants are eating in run-in period."
15869869|NCT03882645|Other|local usual diet|The nutrients targets and total energy in usual diet are set according to how much participants are eating in run-in period.
15869870|NCT03882632|Device|Fat Grafting for Fecal Incontinence|Autologous adiopse tissue harvesting/grafting using Lipogems
15869871|NCT03882619|Behavioral|Calligraphy|Participants will (1) detect the emotion him or herself; (2) do the calligraphy activity by writing positive terms (e.g., peace, life); (3) detect emotion again; (4) share the experience with group members.
15869872|NCT03882606|Device|Scharioth Macula Lens (SML, Medicontur)|magnifying intraocular lens for pseudophakic patients implanted in the ciliary sulcus in one eye of each patient
15869873|NCT03882593|Procedure|Analysis of arterial filters after CPB|At the end of surgery, the arterial filter is withdrawn from cardiopulmonary bypass circuit to be prepared and analysed by SEM.
15869874|NCT03882580|Drug|Anti-Cancer Agents|Drugs and treatments used in cancer inducing cardiovascular and metabolic side effects
15869875|NCT03882567|Other|Electro Neuro adaptative Regulator|The SCENAR device has been previously described and generates high-amplitude, pulsed, damped biphasic sinusoidal current that is delivered to the tissue via a pair of concentric electrodes placed in direct contact with the target area. The intensity of the interactive waveform adjusts in response to changes in skin impedance
15869876|NCT03882554|Device|PoNS Treatment|"PoNS Treatment will consist of three stages: an in-clinic training program, a home training program, and an extended home training program. During all stages of the study, subjects will complete three training sessions per day, morning, afternoon and evening, 6 days per week.
~Daily Training Program: The same daily training program will be performed during all stages with the exception of the morning BAT session, which is not performed during stage 2 or 3:
~Morning:
~Warm Up Exercises without the PoNS Balance Training with PoNS Gait Training with PoNS Breathing and Awareness Training (BAT) with PoNS 3- to 4-hour break between morning and afternoon sessions
~Afternoon:
~Balance Training with PoNS Movement Control Training without PoNS Gait Training with PoNS
~Evening:
~Breathing and Awareness Training with PoNS To be performed at home during all stages"
15869877|NCT03882541|Other|Music therapy|To evaluate the effect of music in patients anxiety and pain during perioperative process in surgical intervention with regional anaesthesia without sedatives or anxiolytics.
15869878|NCT03882541|Drug|Sedation with midazolam|To evaluate the effect of sedation (in comparation with music group) in patients anxiety and pain durin perioperative process in surgical intervention with regional anesthesia without music
15869879|NCT03882528|Biological|Plasmodium falciparum malaria parasite|Laboratory cultured Plasmodium falciparum strain 3D7 delivered via the bite of 5 infected mosquitoes with salivary gland scores of at least 2+ (11-100 sporozoites observed).
15869880|NCT03882515|Other|Myofascial Release|With the right hand in hand exerts caudal pressure in the superior fibers of the muscle, both sides by a minute and a half each. In the ventral decubitus, apply pressure and slip from T12 to the base of the skull nine times. Thumb in the individual's acromion and with the other to hold the pressure and slide in the direction of the other acromion three times. Hand at the base of the skull and with the contralateral tenar region perform pressure and slip in caudal direction on both sides by three times. Hand at the base of the skull and with the contralateral thumb exerting pressure and slip of C3 the distal insertion of the upper fibers on both sides. Thumbs at the base of the skull, exerting lateral traction of the fascia in opposite directions. Dorsal decubitus, thumbs above clavicles, perform detachment of fibers for one and a half minutes. Patient sitting, support the head of the metacarpals beside the spinous process from T1 to T12 and exert pressure and slip three times each.
15869908|NCT03882255|Drug|Ponesimod dose range (2 - 20 mg)|Participants will receive ponesimod oral tablet at a dose of 2 mg in Treatment period 1 and as an up-titrating regimen (dose range: 2mg-20mg) in Treatments period 2.
15869909|NCT03882255|Drug|Placebo Propranolol|Participants will be administered placebo propranolol oral capsule from Day 1 to Day 19 in Treatment A of Treatment period 2.
15869881|NCT03882515|Other|Continuous Surface Slip Technique|"Individual in the ventral decubitus, position the entire palmar surface bilaterally in the spinous process of T1 in the caudal direction, performing superficial smoothing in a smooth and rhythmic movement up to T12.
~Return of the hands from the caudal direction towards the cranial direction, bypassing the lateral borders of the trapezius muscle following the direction of the inferior, middle and superior fibers.
~Continue surface smoothing with a smooth and rhythmic movement until the distal insertion of the trapezius upper fibers into the skull and resume step 1 slowly and continuously for 10 minutes."
15869882|NCT03882515|Other|Without intervention|Evaluation and re-evaluation without intervention
15869883|NCT03882502|Other|anodal transcranial direct current stimulation (tDCS)- accompanied naming therapy or sham stimulation|anodal tDCS or sham stimulation will be combined with an intensive naming training and the number of items that could be named will be assessed immediately after the intervention.
15869884|NCT03882489|Drug|Isobaric 2-chloroprocaine|The doses of isobaric 2-chloroprocaine will be administrated intrathecally and will be adjusted according to the observed responses in the previous subjects.
15869885|NCT03882476|Diagnostic Test|InSight|Clinical decision support (CDS) system for sepsis detection
15869886|NCT03882463|Device|Continuous glucose monitoring with the stop insulin pump function|"Children with type 1 diabetes using insulin pump and continuous glucose monitoring without the stop insulin pump functionare then using the predictive system for stopping before hypoglycaemia medtronic Minimed with SmartGuard technology."
15869887|NCT03882450|Procedure|Flexible fiberoptic laryngoscopy|Flexible fiberoptic laryngoscopy with examination and video documentation of laryngeal function preoperatively (if the participant is not intubated and is stable enough to do so) and postoperatively with a 2.4mm flexible laryngoscope will be performed.
15869888|NCT03882450|Procedure|Laryngeal ultrasonography|Laryngeal ultrasonography will be performed using a portable ultrasound system while the participants are awake.
15869889|NCT03882437|Biological|RP-A501|RP-A501 is a gene therapy product consisting of a rAAV9 capsid containing the human LAMP2B transgene which will be administered as a single IV infusion.
15869890|NCT03882424|Biological|TRS003|25mg/mL (4 mL/vial) Injection，Single dose of 3mg/kg Intravenous infusion for 90 minutes
15869891|NCT03882424|Biological|China-approved Bevacizumab|25mg/mL (4 mL/vial) Injection，Single dose of 3mg/kg Intravenous infusion for 90 minutes
15869892|NCT03882424|Biological|US-licensed Avastin|25mg/mL (4 mL/vial) Injection，Single dose of 3mg/kg Intravenous infusion for 90 minutes
15869893|NCT03882411|Behavioral|Electronic shared decision making (eSDM) tool|The web application includes depression screening, behavioral activation, and a patient preference driven treatment selection decision aid. Treatment options will include medications, cardiac rehab/exercise program, and therapy. Providers will receive a patient preference report in real time with options for coordination of care.
15869894|NCT03882398|Other|Balance|"Balance program (10 minutes)
~Balance on bosu ball and ball drills Coordination in rings with single leg stance and ball drills Straight line walk with head up Straight line walk and hip flexion, knee flexion and head up
~(Duration: 10 minutes. Sets: 2 minutes per exercise. Rest: 30 seconds between exercises)"
15869895|NCT03882398|Other|Endurance|"Progressive-cycle program (15-25 minutes)
~Warming up Pedalling with 0 resistance (2 minutes)
~Main Part* Week 1-2 : 3x2 minutes Week 3-4 : 4x2 minutes Week 5-6 : 5x2 minutes Week 7-8 : 6x2 minutes
~Return to resting stage Pedalling with 0 resistance (1 minute)
~(*Pedalling with resistance set at 3-4. Rest: 2 minutes between sets or 120 beats/minute. One more set added every two weeks and workout intensity maintained at 70% of heart rate reserve-HRR)"
15869896|NCT03882372|Device|Nasal high flow|See arm description.
15869897|NCT03882359|Diagnostic Test|Echocardiogram|"Images will be recorded in parasternal long, short axis, apical four, two, and three chamber views according to the American Society of Echocardiography (ASE) 17 segment model. Each assessment will include one round of low MI imaging (<0.3) and one round of very low MI imaging (<0.2) in each of the pre-specified windows according to the 2014 ASE Sonographer Guidelines.
~A baseline echocardiogram will be performed prior to the administration of DEFINITY® or MVT-100. Assessments will be made three times, once from 0 - 1 ½ minutes following injection, once between 1 ½ minutes to 3 minutes following IV injection and once from 3 - 4 ½ minutes following IV injection. Assessments at each time point will include one round of low MI imaging (<0.3) and one round of very low MI imaging (<0.2). Each round will include the views in the following order: parasternal long, parasternal short, apical 4, apical 2 and apical 3."
15869898|NCT03882359|Drug|MVT-100|After randomization, MVT-100, the experimental drug, is administered via IV infusion or bolus administration and echocardiograms are subsequently obtained.
15869899|NCT03882359|Drug|Definity|After randomization, Definity, the active comparator, is administered via IV infusion or bolus administration and echocardiograms are subsequently obtained.
15869900|NCT03882346|Combination Product|LifeLiver|LifeLiver is an extracorporeal bioartificial liver (BAL) system. The system has shown remarkable detoxification capacity and sustained hepatic functions and also provides a bridge to transplant for patients who are unable to receive timely liver transplantation.
15869901|NCT03882333|Other|Acute exercise|30 min acute exercise (bicycle at stationary cycle)
15869902|NCT03882320|Procedure|Patient Controlled Analgesia (PCA)|Patient Controlled Analgesia (PCA)
15869903|NCT03882307|Drug|sofosbuvir and daclatasvir|oral tablets
15869904|NCT03882294|Other|Probiotics|Participants will be requested to consume the drinks (80 ml) twice a day - after lunch and dinner for 12 weeks.
15869905|NCT03882294|Other|Placebo|Participants will be requested to consume the drinks (80 ml) twice a day - after lunch and dinner for 12 weeks.
15869906|NCT03882281|Drug|HQP1351|Orally, single dose of 30mg on day 1 and day 8.
15869907|NCT03882268|Behavioral|MIYCN interventions|"Capacity building for health provider and nutritional counselors (training on MIYCN SBCC from A&T)
~Available and dedicated space for MIYCN counseling with standard layout, logo and specifications.
~Availability of standardized MIYCN-specific BCC materials and job aids
~Regular counseling services offered by a dedicated counselor hired by A&T
~Routine counselling on IFA and calcium supplementation from dedicated counselor during ANC contact
~Counseling on weight monitoring and availability of standard weighing scales
~Breastfeeding and complementary feeding related counseling regularly offered as a service by a dedicated counselor
~Dedicated community worker to identify and mobilize beneficiaries needing services in the community; use of mass media to improve awareness; scheduled follow ups"
15869910|NCT03882255|Drug|Propranolol 80 mg|Participants will receive propranolol 80 mg long acting oral capsule from Day 1 to Day 19 in Treatment B of Treatment period 2.
15869911|NCT03882242|Behavioral|Facilitation of a school-based program|Participants deliver the prevention program (described in previous research) to school-children.
15869912|NCT03882229|Device|MED-EL CI systems|• Cochlear Implant (CI) and external audio processor
15869913|NCT03882216|Procedure|soft tissue augmentation using pouch technique|crestal incision with split thickness flap without vertical releasing incision till the mucogingival line then apply the harvested connective tissue graft through it.
15869914|NCT03882216|Procedure|soft tissue augmentation using modified pouch technique|tunneling will be done at the pontic site till the mucogingival line then a distant vertical incision near the tunnel at the lining mucosa where the harvested connective tissue graft wll be applied .
15869915|NCT03882203|Drug|CLAGE-FluBu|Cladribine combined with cytarabine and VP16 sequential with Fludarabine combined with busulifan
15869916|NCT03882190|Drug|GnRHa|patients in the experimental group are supposed to receive GnRHa preoperatively and postoperatively according to their individual situation
15869917|NCT03882177|Drug|Pravastatin|Tablets, administered orally
15869918|NCT03882177|Drug|Rifafour|Fixed-dose combination (isoniazid, rifampin, pyrazinamide, and ethambutol) tablets, administered orally
15869919|NCT03882177|Dietary Supplement|Vitamin B6|Administered orally.
15869920|NCT03882164|Diagnostic Test|Blood-Bile Ratio of Tacrolimus|Diagnosis of early transplanted liver dysfunction to adjust Tacrolimus dose adminstered
15869921|NCT03882151|Diagnostic Test|electrical source imaging|automated analysis of surface EEG with electrocal source imaging
15869922|NCT03882138|Procedure|open flap debridement|Modified Widman flap surgery followed by meticulous debridement, root planning and thorough irrigation with normal sterile saline solution
15869923|NCT03882125|Behavioral|Mindfulness-based relapse prevention|Psychosocial intervention integrating mindfulness practice and cognitive behavioral relapse prevention approaches
15869924|NCT03882112|Drug|HIP1601 40mg|Single dosing of HIP1601 40mg, orally
15869925|NCT03882099|Diagnostic Test|Determination of Vitamin D by ELISA|Blood samples
15869926|NCT03882086|Other|foot reflexology|Four sessions foot reflexology was applied for 15 minutes in each foot, every other days between postpartum 14th- 20th day
15869927|NCT03882073|Procedure|Modified amputation procedure|A fishmouth incision will be made. Radial and ulnar (BEA) or humoral (AEA) osteotomies will be performed. Segments of the flexor carpi radialis (FCR), extensor carpi radialis longus (ECRL), flexor digitorum profundi (FDP), extensor digitorum communis (EDC), flexor pollicis longus (FPL) and extensor pollicis longus (EPL) will be isolated, as well as the biceps (B) and triceps (T) groups in the AEA model; if it is not possible to preserve native innervation to these muscles, functional motor units will be constructed from muscle coapted to the appropriate motor nerve endings. Sensory nerve endings of the distal median, ulnar and radial nerves will then be isolated and redirected to discrete skin patches in the proximal residual forearm or proximal brachium. Coaptation of the FCR/ECRL, FDP/EDC, FPL/EPL and B/T muscles will then be performed to promote dynamic coupling of these agonist/antagonist pairs. The skin envelope will then be closed in layers over percutaneous drains.
15869928|NCT03882073|Procedure|Standard amputation procedure|Amputation is performed via standard techniques at either the BEA or AEA level. No construction of agonist-antagonist muscle pairs will be performed.
15869929|NCT03882060|Drug|erythropoietin|Recombinant human erythropoietin (500 U/kg IVS x 3 times) is administrated to increase the neovascularization after revascularization surgery.
15869930|NCT03882060|Drug|Normal saline|Control group, no intervention.
15869931|NCT03882047|Drug|Mometasone furoate|Mometasone furoate nasal spray, 200 mg once daily
15869932|NCT03882047|Drug|Fluticasone propionate|Fluticasone propionate nasal spray, 200 mg once daily
15869933|NCT03882047|Drug|Mometasone furoate placebo|Mometasone furoate placebo matching nasal spray, once daily
15869934|NCT03882047|Drug|Fluticasone propionate placebo|Fluticasone propionate placebo matching nasal spray, once daily
15869935|NCT03882034|Drug|Pegvisomant|A fixed dose of pegvisomant 10-mg started on Day 1 of intervention and continued daily afterwards, will be administered subcutaneously according to manufacturer's recommendations. Adjustment of the dose will occur as per protocol.
15869936|NCT03882021|Procedure|A specific electrophysiology mapping protocol is applicable with the GRID catheter.|The procedure will be done according to a standard ablation approach. During the electrophysiology study, additional mapping data will be collected to support the study endpoints using the GRID catheter.
15869937|NCT03882008|Drug|Abatacept|All the subjects will receive Abatacept subcutaneous injection once a week for 24 weeks
15869938|NCT03881995|Drug|IGlarLixi|Dose titration will be done based on the subjects fasting blood glucose
15869939|NCT03881995|Drug|Insulin Glargine 100 UNT/ML|Dose titration will be done based on the subjects fasting blood glucose
15869940|NCT03881982|Other|PIMPERNEL Novel Electronic Log: Pain display can be seen|Pain scores are displayed on the screen when the participant presses the corresponding button
15869941|NCT03881982|Other|PIMPERNEL Novel Electronic Log: Pain display is hidden|Participants press the buttons to record their pain score but the score is not on display (the screen is turned backwards).
15869942|NCT03881969|Behavioral|Financial Payment of £100|No financial payment
15869943|NCT03881956|Behavioral|Health-promoting lifestyle education program|The intervention group were included in the health-promoting lifestyle education program. The education program consisted of three 45-min sessions, which included a face-to-face lecture with the dissemination and presentation of written and visual materials. Each participant in the intervention group was given the Health-Promoting Lifestyle Booklet and the Diary of a Woman with GDM card. The booklet features all of the health-promoting practices (self-monitoring of blood glucose, nutrition, physical activity, stress, sleeping, smoking, self-care and breastfeeding). The Diary of a Woman with GDM card features the daily program that women should follow (the hours for main meals and snacks, insulin hours, etc.). The education and counseling were maintained through follow-up via phone for intervention group.
15869944|NCT03881943|Drug|Ticagrelor 60 mg|Potent antiplatelet agent, 60mg twice daily for 3 months
15869945|NCT03881943|Drug|Aspirin 100 MG Oral Tablet, Enteric Coated|antiplatelet agent, 100mg once daily for 3 months
15871778|NCT03867812|Other|Control food|Chexmix (General Mills Inc.), Honey Nut Flavor
15869946|NCT03881930|Other|Balance rehabilitation with modified visual input|Patients will perform the exercises alternatively: while keeping their eyes closed or their vision will be obstructed by a opaque mask or disturbed by moving luminous dots projected on the environment in a dark room without any visual reference cues.
15869947|NCT03881930|Other|Balance rehabilitation with no modified visual input|Patients will perform the exercises while keeping their eyes openned
15869948|NCT03881917|Diagnostic Test|Cystatin c and beta 2 microglobulin kits|Kits for measurement concentration
15869949|NCT03881904|Drug|0.075mg gestodene/0.03mg ethinylestradiol|OCPs will be started from day 2 of the cycle preceding COH and continued for 21 days, then induction of ovulation using antagonist protocol will be started.
15869950|NCT03881891|Behavioral|Follow-app intervention arm|The intervention includes implementation and evaluation of the effectiveness of a mobile phone-based text messaging system (FollowApp.Care) to collect patients' assessments of their post-op symptoms (pain intensity) and to use that data to improve their quality of care (pain experience) in the dental office setting
15869951|NCT03881878|Drug|TAHP and AHP|"(A, Neoadjuvant setting): D1 X 6 cycles, q3weeks
~Docetaxel (75mg/m2, IV)
~Atezolizumab (1200mg, IV)
~Tastuzumab (600mg, SC)
~Pertuzumab (840mg loading dose at Cycle 1 followed by 420mg, IV)
~(B, Adjuvant setting) : patients with pCR:D1 X 11-12 cycles, q3weeks
~Atezolizumab (1200mg, IV)
~Trastuzumab (600mg, SC)
~Pertuzumab (420mg, IV)"
15869952|NCT03881878|Drug|TAHP plus AC and AHP|"(A, Neoadjuvant setting): D1 X 6 cycles, q3weeks
~Docetaxel (75mg/m2, IV)
~Atezolizumab (1200mg, IV)
~Tastuzumab (600mg, SC)
~Pertuzumab (840mg loading dose at Cycle 1 followed by 420mg, IV)
~(B, Adjuvant setting) : patients with non-pCR
~Doxorubicin(60mg/m2) plus cyclophosphamide (600mg/m2) D1 X 4cycles q3weeks followed by
~Atezolizumab (1200mg, IV), Trastuzumab (600mg, SC) and Pertuzumab (420mg, IV) D1 X 11-12 cycles q3weeks"
15869953|NCT03881852|Drug|AXS-12 (Reboxetine)|Dosed orally, twice daily for up to 3 weeks
15869954|NCT03881852|Drug|Placebo|Dosed orally, twice daily for up to 3 weeks
15869955|NCT03881839|Other|emergency|The objective of this research will be to assess, in patients presenting in an emergency department, the prior consultation of medical information on a website, the impact on the emergency consultation decision and the relevance of this consultation.
15869956|NCT03881826|Other|collection of clinical data and biological samples|"nutritional assessement
~cachexia symptoms
~urine, feces and blood samples"
15869957|NCT03881813|Device|Orthodontic retainers|Orthodontic retainers were bonded on the lower teeth of the subjects after fixed orthodontic treatment and were evaluated for their effectiveness for the followup of one year.
15869958|NCT03881800|Other|titration- blood sample|Ceftazidime titration
15869959|NCT03881787|Drug|anti-EGFR monoclonal antibody|Recombinant anti-EGFR human mouse chimeric monoclonal antibody injection
15869960|NCT03881787|Drug|Cetuximab injection|Cetuximab injection
15869961|NCT03881774|Biological|CAR-T cells|collecting cord blood for CAR-T cells culture; three days later, FC regimen (fludarabine 30mg/m2/d x 3, cyclophosphamide 600-800mg/m2/d x 2) another two days later, transfusing CAR-T cell with a dose of 0.5-3x106/kg
15869962|NCT03881761|Biological|CD19/CD20 bispecific CAR-T cells|collecting blood for CAR-T cells culture three days later, FC regimen (fludarabine 30mg/m2/d x 3, cyclophosphamide 600-800mg/m2/d x 2) another two days later, transfusing CD19/CD20 bispecific CAR-T cell with a dose of 1-3x106/kg
15869963|NCT03881748|Other|Manual acupuncture|"Manual acupuncture twice a week for 20 treatments.
~Acupuncture will be administered on an outpatient basis in private rooms with participants lying supine. The acupuncturist will disinfect the selected acupuncture points with alcohol and then needle them so that the participant achieves a de qi sensation if possible, which is often described as a pressure or achiness feeling. Acupuncture needles will be left in place for approximately 20 minutes."
15869964|NCT03881748|Other|Electro-acupuncture|"Electro-acupuncture twice a week for 20 treatments.
~Acupuncture will be administered on an outpatient basis in private rooms with participants lying supine. The acupuncturist will disinfect the selected acupuncture points with alcohol and then needle them so that the participant achieves a de qi sensation if possible, which is often described as a pressure or achiness feeling. Acupuncture needles will be left in place for approximately 20 minutes.
~Electrical stimulation will be applied to the needles concomitantly and continuously to acupuncture points by placing lead wires on the needles connected to an electro-acupuncture stimulator such as the Model IC-1107. The stimulator will be set on the Dense-Disperse wave setting with low frequency at 2-10 Hz and high frequency at 100-110 Hz. The needles will not be manually stimulated after electrical stimulation is applied."
15869965|NCT03881735|Drug|Enasidenib|Given PO
15869966|NCT03881735|Procedure|Hematopoietic Cell Transplantation|Undergo HCT
15869967|NCT03881722|Dietary Supplement|Mg alginate|Mg alginate after feedings
15869968|NCT03881709|Behavioral|Using an E-Book|The intervention group will receive the biopsy decision support intervention delivered by a nurse using an E-Book containing a comprehensive information about prostate biopsy.
15869969|NCT03881696|Drug|Omalizumab|Omalizumab will be supplied in pre-filled syringes (PFS). PFS of omalizumab will be provided to the clinical research units as 75 mg and 150 mg dosage forms.
15869970|NCT03881696|Drug|Placebo for Omalizumab|Placebo contains the same ingredients as the omalizumab formulation, excluding omalizumab. Placebo will be supplied in pre-filled syringes (PFS). PFS of placebo will be provided to the clinical research units as 75 mg and 150 mg dosage forms.
15869971|NCT03881696|Drug|Multi-Allergen Oral Immunotherapy|"Multi-allergen OIT will be any of the following drug products: peanut, milk, egg, wheat, cashew, hazelnut, and walnut (all food protein flours).
~A prescription for each participant for the appropriate dose of each of the allergens will be prepared. The pharmacist will compound the appropriate allergens and dispense the Multi-allergen OIT dose in a blinded (masked) fashion. The Clinical Research Unit (CRU) staff will administer food flour to the participant orally in an age-appropriate food vehicle (e.g., applesauce, pudding, etc.). Dosage will be administered according to the study protocol."
15869972|NCT03881696|Drug|Placebo for Multi-Allergen Oral Immunotherapy|Oat flour will be used for placebo for Multi-allergen OIT. Route: by mouth/oral. Dosage will be administered according to the study protocol.
15870005|NCT03881371|Other|Placebo|At baseline (Day 1), eligible patients will be randomised to receive matching placebo, orally OD. Placebo will be added to the standard stabilized treatment as a control of the safinamide group, hence patients on placebo will have benefit from other ongoing anti-PD medication
15883520|NCT03777800|Behavioral|Treatment as usual|Standard treatment
15869973|NCT03881696|Other|Double-Blind Placebo-Controlled Food Challenge Based Treatment|"Each participant will receive a separate treatment plan for peanut and each of the two other participant-specific foods. A treatment plan will include instructions for one of the following:
~Long-term follow-up with dietary consumption of a food; or
~Long-term follow-up with avoidance of a food; or
~Rescue OIT for a food. The treatment plan for each food may change depending on a participant's response to prescribed treatment over time."
15869974|NCT03881683|Diagnostic Test|HRD and BRCA mutations|Compare BRCA1/2 and HRD genes mutation detected from blood sample (20 ml) and biopsy
15869975|NCT03881670|Device|Lotrafilcon B|commercially available contact lens
15869976|NCT03881670|Device|lotrafilcon B with Hydraluxe|commercially available contact lens
15869977|NCT03881657|Behavioral|Reverse Colocated Integrated Care|A reverse colocated integrated care model is one where primary care and preventive services are embedded within a behavioral health service setting.
15869978|NCT03881657|Behavioral|Usual Care|Behavioral health services without primary care or integrated care services
15869979|NCT03881644|Drug|Imigran|All patients will undergo this intervention on one of two study days
15869980|NCT03881644|Other|Isotonic Saline|All patients will undergo this intervention on one of two study days
15869981|NCT03881644|Other|Pituitary adenylate cyclase-activating peptide-38|All patients will undergo this intervention on both study days
15869982|NCT03881631|Behavioral|Mindfulness Based Stress Reduction Program|Group-based intervention
15869983|NCT03881631|Behavioral|Living Well Program|Group-based intervention
15869984|NCT03881618|Procedure|electroacupuncture+auricular pressure,|electroacupuncture+auricular pressure for 20 minutes
15869985|NCT03881605|Diagnostic Test|MRI screening|A standard contrast-enhanced MRI and Chemical Exchange Saturation Transfer (CEST) MRI of the brain will be performed at baseline, 4 months, 8 months and 12 months.
15869986|NCT03881579|Behavioral|nurse-led supportive care assessment|Trained project nurses will conduct systematic assessment and provide coaching to patients in the experimental arm
15869987|NCT03881553|Device|NEATCAP|NEATCAP: Neurosensory, Environmental Adaptive Technology is a sound attenuating earmuff that reduces unsafe high-frequency noise.
15869988|NCT03881553|Device|SVS mattress|SVS mattress: Stochastic Vibratory Stimulation is a mattress that provides gentle, random, vibrotactile stimulation.
15869989|NCT03881540|Other|tDNA-MI group|tDNA care with structured low calorie meal plan of 1200-1500 kcal/day with conventional foods + 1-2 serving of diabetes specific meal replacements and motivational interviewing counseling. .
15869990|NCT03881540|Other|tDNA-CC group|tDNA care with structured low calorie meal plan of 1200-1500 kcal/day with conventional foods + 1-2 serving of diabetes specific meal replacements+ 150 min/week of moderate intensity exercise + and conventional counselling.
15869991|NCT03881540|Other|UC group|Meal plan of 1200-1500 kcal/day using conventional foods + 150 min/week of moderate intensity exercise + and conventional counselling
15869992|NCT03881527|Device|Aortic valve replacement using a nitinol blade|A circular nitinol blade will be inserted by to cut the aortic valve leaflets during conventional aortic valve replacement procedure
15869993|NCT03881527|Procedure|aortic valve replacement|Aortic valve replacement in a standard fashion
15869994|NCT03881488|Drug|CTX-471|IV infusion every 2 weeks
15869995|NCT03881475|Other|questionnaire|"During consultations in occupational medicine (periodic visit and / or visit at the request of the employee), the nurses (or physicians) will propose the passation of the questionnaire to the voluntary agents.
~The questionnaire, composed of 79 items with 2 validated questionnaires (HAD and MBI), will be filled using a digital tablet (via the REDCAP software).
~Time required to complete the questionnaire 10 minutes."
15869996|NCT03881462|Procedure|Axillary nerve block for artificial deltoid muscle palsy|"Axillary nerve block block (AXNB):
~The ultrasound probe is placed transversally in the infraclavicular region with the arm in 90° abduction. The brachial plexus and its cords are identified l lateral to the brachial artery. The posterior cord is identified by ultrasound and is blocked - or, if the axillary nerve visible too - the axillary nerve is selectively blocked when it leaves the posterior cord and lies on the subscapular muscle accompanied by the posterior circumflex humeral artery. Using an in-plane technique, a short bevel connected to a nerve stimulator with the setting 0.5 mA current intensity, 0.1 ms impulse duration and 2 Hz impulse frequency for dual guidance, will be advanced until its tip is positioned near the nerve without eliciting motor contractions. After careful negative (for blood) aspiration local anesthetic will be applied until the targeted neuronal structure is surrounded by the injected fluid."
15869997|NCT03881449|Combination Product|ABILIFY MYCITE|Initiation of ABILIFY MYCITE will commence immediately, with subjects wearing the patch and using the smartphone app for a total of 3 months from baseline visit to the 3 month visit. Following the initial 90-days, the physician and patient may determine to use ABILIFY MYCITE anytime during the following 9 months. Following this period (up to 12 months), the subjects will not use ABILIFY MYCITE and return to standard care. A safety follow-up phone call will occur at 2 weeks after the 12 month/early termination (ET) visit. In addition, individuals in the ABILIFY MYCITE arm will evaluate satisfaction with the use of ABILIFY MYCITE.
15869998|NCT03881436|Diagnostic Test|MRI with DTI sequence|"At the end of the planned sequence, but before any contrast agent injection:
~Acquisition of a an additional anatomical T2 SPACE sequence
~Acquisition of a tractography DTI sequence"
15869999|NCT03881423|Drug|Rocuronium Bromide|DEEP block to PTC 1-3
15870000|NCT03881410|Procedure|different types of ultrasound technique|Shear-wave elastography-guided or Convention ultrasound-guided
15870001|NCT03881397|Behavioral|Family Media Use Plan|A tool developed by the American Academy of Pediatrics that engages teens and parent to discuss internet safety ideas and develop rules around technology use together.
15870002|NCT03881397|Behavioral|Media Use Resources Awareness|Resources offered to parents and teens that include tools and publicly available resources for safe technology use among teens
15870003|NCT03881384|Other|ctDNA level during neoadjuant chemotherapy|Draw blood from each enrolled patient every time before chemotherapy and measure the ctDNA level in plasma.
15870004|NCT03881371|Drug|Safinamide|At baseline (Day 1), eligible patients will be randomised to receive safinamide (initial 50 mg titrated to 100 mg the day after the Visit 3/week 2, ideally at day 15). The investigational medicinal product (IMP) will be taken in the morning at breakfast time, in addition to the morning dose of L-dopa and other (if any) PD medications.
15870006|NCT03881358|Device|ortho-k lenses and thinner spectacles|Conventinally designed (Emerald) ortho-k lenses (target for -4.00D) and thinner specs during day time
15870007|NCT03881358|Device|newly designed ortho-k lenses|Newly designed (Topaz) ortho-k lenses for high myopia (target for full correction)
15870008|NCT03881345|Drug|Anticoagulants|anticoagulation according to the main diagnosis
15870009|NCT03881345|Procedure|Open surgery|removal of blood clots with open surgery
15870010|NCT03881345|Procedure|Thrombolysis|removal of blood clots with thrombolysis
15870011|NCT03881345|Procedure|Venous stenting|elimination of vein obstruction by stenting
15870012|NCT03881319|Drug|Conventional gynecologic treatment|Taking NSAIDs or oral contraceptives.NSAIDs include Ibuprofen, Naproxen, Diclofenac, and Piroxicam. Oral contraceptives include Yasmin.
15870013|NCT03881319|Device|Low dose acupuncture|Six acupoints: Three Yin Intersection( SP6)、Grandfather Grandson(SP4)、 Sea of Blood(SP10) 、Sea of Qi(RN6)、Origin Pass(RN4) 、Inner Pass(PC6)
15870014|NCT03881319|Device|High dose acupuncture|Twelve acupoints: Three Yin Intersection( SP6)、Grandfather Grandson(SP4)、 Sea of Blood(SP10) 、Sea of Qi(RN6)、Origin Pass(RN4) 、Middle Extremity(RN3)、Inner Pass(PC6) 、Supreme Rush(LR3) 、Joining Valley(LI4) 、Supreme Stream(KI3) 、Uterus(EX-CA1) 、Leg Three Miles(ST36)
15870015|NCT03881306|Drug|D-TACE|D-TACE with CalliSpheres-Oxaliplatin
15870016|NCT03881293|Drug|lidocaine 2% gel|Transurethral instillation of 5 ml lidocaine 2% gel
15870017|NCT03881293|Drug|water soluble lubricant|Transurethral instillation of 5 ml water soluble lubricant
15870018|NCT03881280|Behavioral|Parenting education program|"Parenting education program through the app Fammeal. It includes educational content, tailored to parents and centered on positive parenting child-feeding practices. The app will also include a virtual-pet game for children, in order to help them self-regulate their intake.
~Through the app, parents will:
~Fill in a registration questionnaire, which will tailor recommendations.
~Receive information and video content recommendations.
~Set goals related to their child's lifestyle and tracking progress.
~Earn points by watching the contents.
~Invite children to play a serious game.
~Exchange messages with other users.
~The investigators created a support website that connects to the main server to get data gathered from the mobile app and game."
15870019|NCT03881267|Other|Human Autologous Homologous Skin Construct|Application of a autologous human derived skin polar units
15870020|NCT03881267|Other|Additional Outer Dressing Application|Application of Moisture retentive dressing, and a multi-layer compression dressing
15870021|NCT03881267|Other|Fibracol Wound Dressing|Application of Collagen Alginate Dressing
15870022|NCT03881254|Other|Human Autologous Homologous Skin Construct|Application of a autologous human derived skin polar units
15870023|NCT03881254|Other|Additional Outer Dressing Applicaiton|Application of Moisture retentive dressing, and a multi-layer compression dressing
15870024|NCT03881254|Other|Offloading|Patient will be offloaded in a diabetic camboot after treatment, or total contact cast if patient cannot be fit with diabetic offloading boot
15870025|NCT03881254|Other|Fibracol Wound Dressing|Application of Collagen Alginate Dressing
15870026|NCT03881228|Behavioral|Increasing the completion of IPT|Behavioral intervention with three components to increase the completion of IPT among children
15870027|NCT03881215|Procedure|Platelet Rich Plasma|Platelet Rich Plasma
15870028|NCT03881215|Procedure|intra-uterine balloon|intra-uterine balloon
15870029|NCT03881202|Device|PoNS Treatment|"PoNS Treatment will consist of three stages: an in-clinic training program, a home training program, and an extended home training program. During all stages of the study, subjects will complete three training sessions per day, morning, afternoon and evening, 6 days per week.
~Daily Training Program: The same daily training program will be performed during all stages with the exception of the morning BAT session, which is not performed during stage 2 or 3:
~Morning:
~Warm Up Exercises without the PoNS Balance Training with PoNS Gait Training with PoNS Breathing and Awareness Training (BAT) with PoNS 3- to 4-hour break between morning and afternoon sessions
~Afternoon:
~Balance Training with PoNS Movement Control Training without PoNS Gait Training with PoNS
~Evening:
~Breathing and Awareness Training with PoNS To be performed at home during all stages"
15870030|NCT03881189|Device|SUNEKOS® 200|The intradermal injection procedure was performed bilaterally, on the area around the eyes including the eyelids, using periosteal and subepidermal injection techniques. This injective procedure consists of micro-wheals of 0.2 ml just above the periosteum and micro-wheals of 0.1 ml very superficially, just under epidermis.
15870031|NCT03881176|Device|PoNS Treatment|"The study site will deploy either PoNS Treatment Schedule A or PoNS Treatment Schedule B. Both PoNS Treatment Schedules will consist of three stages: an in-clinic training program, a home training program, and an extended home training program.
~During all stages of the study, subjects will complete three training sessions per day, morning, afternoon and evening, 6 days per week. Daily evening sessions and training sessions on weekends will always be performed independently, at-home by the subject"
15870032|NCT03881163|Drug|N-acetylcysteine (NAC)|Two ampoules of IMP (300 + 300 mg) corresponding to a total dose of 600 mg of NAC diluted in 10 mL of NaCl 0.9% sterile saline solution, will be administered by a 5-minute i.v. infusion.
15870033|NCT03881150|Other|Comprehensive assessment|Includes evaluation about physical activity, diet, tobacco consumption, overweight/obesity, blood pressure, self-efficacy, and medications. Additionally, levels of lipids and glycaemia will be reviewed from clinical chart.
15870034|NCT03881150|Other|Counseling|Physical activity, diet, smoking, and medication compliance counseling will be provided by the physiotherapist across exercise sessions, using a self-efficacy approach. A booklet was designed in order to support the individual counseling.
15870035|NCT03881150|Other|Group education|Group education sessions about physical activity, diet, smoking, and medication compliance (without individual counseling), as actually performed in each center.
15870036|NCT03881150|Other|Exercise sessions in hybrid program|"10 supervised exercise sessions over 4-6 weeks of aerobic and resistance training will ensue, supervised by a physiotherapist. Exercise sessions are 10 minutes in duration at the beginning of the program, and are progressed to 60 minutes by the end as tolerated.
~Intensity of exercise will be moderate."
15870037|NCT03881150|Other|Exercise sessions in standard program|"18-22 supervised exercise sessions are delivered over the 8-12 week program. These sessions include aerobic and resistance training and a similar progression of duration as the experimental group.
~Intensity of exercise will be moderate."
15870038|NCT03881150|Other|Transition to unsupervised phase|After 4-6 weeks with face-to-face exercise sessions in hybrid program, all patients will be monitored through mobile technology. Delivery methods will include voice calls biweekly, and text messaging three per week through to 10-12 weeks from program initiation. The content will promote physical activity, healthy diet, and medication adherence.
15870039|NCT03881137|Other|Geriatric assessment with management|"A multicomponent intervention, carried out in cooperation between hospital and community services, based on a geriatric assessment (GA) followed by individually adapted measures targeting identified needs.
~The GA and the start of the intervention will be handled by a PhD student (geriatrician) or project cancer nurse at start of RT. Pre-planned guidelines will be followed. Contribution from relevant hospital professionals will be sought according to needs. Then the intervention will be offered in the primary health care taking advantage of existing services, e.g. home care, rehabilitation services, exercise groups etc. A community-based coordinating nurse will follow the patients with weekly contacts throughout RT and to end of intervention 8 weeks post-RT. To ensure that each patient's intervention is properly adjusted to changing needs, repeated clinical assessments will be performed by the end of RT and 4 weeks post-RT."
15870040|NCT03881111|Biological|Pembrolizumab|200 mg administered IV Q3W on Day 1 of each 3-week cycle, up to 35 administrations.
15870041|NCT03881111|Drug|Placebo|Placebo to pembrolizumab (saline) administered IV Q3W on Day 1 of each 3-week cycle, up to 35 administrations.
15870042|NCT03881111|Drug|Cisplatin|80 mg/m^2 administered IV Q3W on Day 1 of each 3-week cycle. Duration of cisplatin treatment will be capped at 6 doses.
15870043|NCT03881111|Drug|5-FU|800 mg/m^2/day (4000 mg/m^2 total per cycle) administered as continuous IV infusion on Days 1 to 5 (120 hours) of each 3-week cycle, or per local standard for 5-FU administration.
15870047|NCT03881072|Other|Ultrasounicelastography|Observing the correlation between endometrial elasticity score, endometrial blood flow index (PI, RI, S/D, endometrial thickness, morphology) and clinical pregnancy rate.
15870048|NCT03881059|Other|BMS-986165 Placebo|Participants will receive BMS-986165 matching placebo QD
15870049|NCT03881059|Drug|BMS-986165 Dose A|Participants will receive BMS-986165 Dose A QD.
15870050|NCT03881059|Drug|BMS-986165 Dose B|Participants will receive BMS-986165 dose B QD.
15870051|NCT03881059|Drug|Ustekinumab|Participants will receive ustekinumab SQ injection QD.
15870052|NCT03881059|Other|Ustekinumab Placebo|Participants will receive ustekinumab SQ matching placebo QD
15870053|NCT03881033|Other|Peep 5cmH2O|Face mask ventilation with peak inspiratory pressure according to the group P7+5 means face mask ventilation with peak inspiratory pressure 7cmH2O plus PEEP 5 cmH2O.
15870054|NCT03881033|Other|Peak inspiratory pressure|Face mask ventilation with peak inspiratory pressure according to the group P12 means face mask ventilation with peak inspiratory pressure 12cmH2O without PEEP.
15870055|NCT03881020|Drug|Silver diamine Fluoride 38%|In the intervention group 38% Silver Diamine Fluoride will be applied to the surface of the isolated lesion for a period of 1 minute followed by glass ionomer restoration at the same visit.
15870056|NCT03881020|Procedure|Conventional atraumatic restorative treatment|In the active comparator group caries will be removed from primary molars using sharp excavators then teeth will be restored using glass ionomer filling material at the same visit.
15870057|NCT03881007|Other|Mouthwash with LCM|Subjects will mouthwash daily with LCM and before/after sex
15870058|NCT03881007|Other|Mouthwash with placebo|Subjects will mouthwash daily with placebo and before/after sex
15870059|NCT03880981|Drug|Ibuprofen 600 mg|ibuprofen 600mg Po q 6 hours prn pain
15870060|NCT03880981|Drug|Acetaminophen|acetaminophen 600mg po q6 hours prn pain
15870061|NCT03880968|Drug|tapering or discontinuation of etanercept|Active AS patients initially managed with ETN 50mg weekly for 12 weeks, and then randomized into subgroups with different tapering or discontinuation strategies according to ASDAS at week 12. Patients who achieved inactive disease (ASDAS<1.3, group A) at week 12 were either assigned to sequential tapering group (A1) or discontinuation group (A2), and those who reached low disease activity (LDA) (1.3≤ASDAS<2.1, group B) were designated to sequential tapering group (B1), delayed tapering group (B2) or discontinuation group (B3).
15870062|NCT03880955|Device|ReUnion RSA System|The ReUnion RSA System is designed as a reverse total shoulder endoprosthesis to address unrepairable gross rotator cuff tear, rotator cuff arthropathy with pseudoparalysis of the shoulder joint, advanced arthritic and rheumatic disorders affecting the shoulder joint, and failed previous shoulder arthroplasty. The ReUnion RSA System is comprised of a Humeral Cup, Humeral Insert, Glenosphere, Glenoid Baseplate and Screws. The intended purposes of the ReUnion RSA System are to achieve pain relief, improvement of range of motion and restoration or improvement of the shoulder function while ensuring long-term replacement of the shoulder joint with sufficient stability of all endoprosthesis components.
15870063|NCT03880942|Other|Informative story book|Patients will be given a colorful story book that tells the hospital and operation procedure named 'Elif Ameliyat Oluyor'(Elif is undergoing surgery) and will be asked to read the book with children at least once before the operation.
15870097|NCT03880656|Biological|Intramuscular administration of autologous BM-MNCs|Intramuscular administration of autologous BM-MNCs at either a low or high cell dose.
15870064|NCT03880942|Other|Non Informative Story Book|Patients will be given a non-medical colorful story book called 'Çiftlik Öyküleri-Kamp' (Farm Stories-Camp) and will be asked to read the book with children at least once before the operation.
15870065|NCT03880929|Other|no intervention|no intervention
15870066|NCT03880916|Drug|Duloxetine|"Phase I (preemptive): 2weeks before operation (30mg for 2weeks)
~Phase II (maintenance): 6weeks after operation (30mg for 6 weeks) plus routine pain control (celecoxib, pregabalin, acetaminophen/tramadol, oxycodone)"
15870067|NCT03880916|Drug|Placebo|Phase I (preemptive): 2weeks before operation (Placebo for 2weeks) Phase II (maintenance): 6weeks after operation (Placebo for 6 weeks) plus routine pain control (celecoxib, pregabalin, acetaminophen/tramadol, oxycodone)
15870068|NCT03880903|Drug|normal saline and salbutamol|patients will recieve treatment with nebulized salbutamol and normal saline every 4 to 6 in hours
15870069|NCT03880903|Drug|hypertonic saline and salbutamol|patients will recieve treatment with nebulized salbutamol and hypertonic saline 3% in adose of 4ml every 4 to 6 hours
15870070|NCT03880903|Drug|Hypertonic saline|patients will recieve treatment with nebulized hypertonic saline 3% in adose of 4ml every 4 to 6 hours
15870071|NCT03880890|Procedure|sphenoidotomy versus sphenoid nasalisation|sphenoidotomy opening of sphenoid sinus ostum and cleaning of the sinus sphenoid nasalization in which bilateral extended sphenoidotomy, the posterior aspect of the nasal septum is resected, along with the sphenoid rostrum, the intersinus septum, and other intrasphenoid partitions, creating a common cavity with a broad drainage pathway .
15870072|NCT03880877|Drug|Regorafenib|Regorafenib is administered at dose of 120 mg daily for 3 weeks in a 4-week cycle
15870073|NCT03880877|Genetic|UGT1A1 genotyping (TA6/TA6)|The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 260 mg/m2
15870074|NCT03880877|Genetic|UGT1A1 genotyping (TA6/TA7)|The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 240 mg/m2
15870075|NCT03880877|Genetic|UGT1A1 genotyping (TA7/TA7)|The dosage of irinotecan in FOLFIRI is escalated from 120mg/m2 to180 mg/m2
15870076|NCT03880877|Drug|Leucovorin and 5-FU|Leucovorin (400 mg/m2 IV infusion over 2 hours), and 5-FU (2800 mg/m2 IV infusion over a 46-hour period)
15870077|NCT03880864|Radiation|Ultrasound|Lung ultrasound
15870078|NCT03880851|Radiation|Plan adaptation of Radiation Treatment in case of anatomical changes|Image guided radiotherapy is given to 60Gy in 20 fractions. Intervention: Radiation treatment plan adaption in case of volume changes of target volume or not meeting OAR constraints due to volume changes.
15870079|NCT03880838|Behavioral|Personal testimonial|Participants will receive a letter promoting a plant-based diet. This letter will feature a personal testimonial about the benefits of a plant-based diet. Presenting this information to participants might encourage them to make behavioral changes to improve their health.
15870080|NCT03880838|Behavioral|Forks Over Knives Documentary|Participants will be mailed the documentary Forks Over Knives, which provides scientific arguments promoting a plant-based and whole foods diet. The behavioral effect of this documentary comes from watching the documentary and potentially choosing to order a free cookbook (participants are given this opportunity in the letter accompanying the documentary). The effect of the diet itself is not a central part of the intervention, as people can choose to adopt or not adopt any part of the diet.
15870081|NCT03880838|Behavioral|Commitment nudge|At the end of the letter promoting a plant-based diet, participants will be asked to write dates and personal signatures committing to watching the documentary. They will be asked to mail back this written commitment. Stating one's intentions to implement certain behavior is meant to increase the likelihood of follow-up behavior. This request might nudge more people to watch the documentary and make some behavioral changes to prevent negative health outcomes.
15870082|NCT03880838|Behavioral|Prevention nudge|As part of the letter promoting a plant-based diet, one paragraph will describe the risks of not taking action. This phrasing reframes the status quo as contributing to future loss (e.g., costs of medication and operations). In effect, the letter encourages participants to focus on preventing this loss by taking action. This additional text might nudge more people to watch the documentary and make some behavioral changes to prevent negative health outcomes.
15870083|NCT03880825|Drug|Metformin 500 mg Oral Tablet|single dose
15870084|NCT03880825|Drug|Levoketoconazole 150 - 600 mg (BID)|escalating dose from 150 mg to 600 mg (BID)
15870085|NCT03880812|Other|Societal cost|Annual societal cost information to the US for carpal tunnel release surgery was displayed.
15870086|NCT03880799|Behavioral|Mindfulness Session|one hour mindfulness session conducted by a certified mindfulness teacher with the breast cancer patient
15870087|NCT03880786|Device|pudendal PNE test lead|All patients eligible for release surgery will be implanted a PNE test lead (Medtronic) which will be placed (transforaminal or transgluteally) next to the pudendal nerve, at the level of the ischial spine, after surgical release and connected to an external stimulation device. The PNE lead will be fixed at the ischial-spinal ligament with an absorbable suture to prevent dislocation. If a bilateral dissection is needed, bilateral test leads will be placed. Stimulation will be switched on at the second postoperative day, according to the sensory threshold described by the patient. After three weeks the PNE test lead will be removed at the outpatient clinical visit.
15870088|NCT03880773|Device|Stapler|for transection of the pancreas and pancreatic stump treatment
15870089|NCT03880773|Device|ultrasonic shears|for transection of the pancreas and pancreatic stump treatment
15870090|NCT03880760|Other|L. johnsonii MH-68, B. animalis subsp. lactis CP-9 and L. salivarius AP-32|Taking 1 L. johnsonii MH-68, B. animalis subsp. lactis CP-9 and L. salivarius AP-32 mix probiotics capsule twice a day before meals for six months.
15870091|NCT03880760|Other|Placebo|Taking 1 placebo capsule twice a day before meals for six months.
15870092|NCT03880747|Procedure|Vagus nerve-preserving distal gastrectomy|Laparoscopic distal gastrectomy with the preservation of the celiac and hepatic branch of the vagus nerve.
15870093|NCT03880734|Drug|Cholecalciferol|ingredients-Cholecalciferol (40,000 IU),Microcrystalline Cellulose (58.1 gm),Butylated Hydroxy Toluene (0.2 mg),Magnesium Stearate (3 mg),Gelatin Capsule Shell (1 mg)
15870094|NCT03880734|Other|Placebo oral capsule|ingredients- Microcrystalline Cellulose (303.8 gm),Butylated Hydroxy Toluene (0.2 mg),Magnesium Stearate (3 mg),Gelatin Capsule Shell (1 mg)
15870095|NCT03880721|Procedure|Microwave abaltion|Use microwave ablation to treat hepatocellular carcinoma
15870096|NCT03880695|Drug|Anlotinib+ Liposomal Doxorubicin|Anlotinib : 12 mg, qd, po day 8-21 every 3 weeks Liposomal Doxorubicin: 50 mg/m2, day 1 every 3 weeks
15870098|NCT03880630|Other|Inspiratory muscle training|Patients will perform 3 inspiratory loading tests (15%, 30%, and 50% of maximum inspiratory pressures) on 3 separate days with the sequence will be randomized. Patient will then be trained with individualized IMT program based on the results of 3 inspiratory loading tests.
15870099|NCT03880604|Procedure|Triple tourniquets|A number 1 polyglactin suture was tied around the cervix to occlude the uterine arteries, and polythene tourniquets were tied around the infundibulopelvic ligament to obstruct the ovarian vessels
15870100|NCT03880604|Drug|TA|1-gram tranexamic acid (10 ml) in 100 ml saline infusion
15870101|NCT03880604|Other|placebo to TA|placebo to 1-gram tranexamic acid (10 ml) in 100 ml saline infusion
15870102|NCT03880578|Drug|Levothyroxine Sodium|thyroid hormone replacement
15870103|NCT03880565|Device|Early Extracorporeal Membrane Oxygenation (ECMO) Facilitated Resuscitation|Early use of ECMO
15870104|NCT03880565|Device|Standard Advanced Cardiac Life Support (ACLS) Resuscitation|Standard life support resuscitation
15870105|NCT03880552|Other|Primigravid women with singleton pregnancy at 35th week over|Primigravid women with singleton pregnancy at 35th week over; only observational study will be done in this group and the data will be recorded.
15870106|NCT03880539|Drug|bezlotoxumab|Adding BEZLO to SOC oral VAN pulse/taper
15870107|NCT03880539|Drug|Vancomycin Oral|SOC vancomycin pulse/taper
15870108|NCT03880513|Diagnostic Test|Cardiovascular status and quality of life|Psychosocial and cardiovascular evaluation includes medical history, physical examination, laboratory tests, analysis of endothelial function, 24h blood pressure profile, Holter ECG, transthoracic echocardiography, cardiac MRI, and quality of life assessment
15870109|NCT03880500|Other|Spinal Manipulative Therapy|The patient lies in sidelying position, with the hip of the upper leg flexed to 90° and the foot of the flexed leg hooked behind the popliteal space of the downside leg. The chiropractor faces the subject at a 45°-angle, fixates the flexed knee with his own knee/thigh. The fingers of the cephalic hand reach under the patient's upper arm to contact the upside lateral surface of the superior spinous process. The fingers of the caudal hand hook down-side aspect of the spinous process, the forearm contacts the patient's buttock and thigh. The cephalic hand thrusts lateromedially and caudocranially, from upside toward downside (push). The caudal hand thrusts lateromedially in the opposing direction, from downside toward upside (pull). SMT is repeated after the patient turns to left side lying.
15870110|NCT03880487|Drug|KP-1199|Single dose and Multiple ascending doses of KP-1199 oral capsules
15870111|NCT03880487|Drug|Placebo oral capsule|Single dose and Multiple dose identical to active treatment but without KP-1199.
15870112|NCT03880487|Drug|Oxycodone oral capsule|10 mg Oxycodone Capsules
15870113|NCT03880474|Biological|MVA-NP+M1|Trial Vaccine
15870114|NCT03880474|Drug|Saline|Sodium Chloride Placebo
15870115|NCT03880461|Behavioral|Lifestyle Intervention|Behavioral lifestyle intervention
15870116|NCT03880448|Drug|Metronidazole|Metronidazole 500mg/8h/7days
15870117|NCT03880448|Drug|Placebo|Cornstarch 500mg/8h/7days
15870118|NCT03880448|Procedure|periodontal surgery|periodontal surgery
15870119|NCT03880435|Device|Hyalobarrier® gel endo|Intra-uterine application of 10ml sterile gel containing 30mg APC. It will be administered once, peroperatively immediate after the complete hysteroscopic removal of the polyp, myoma, adhesion, uterine septum or retained products of conception
15870120|NCT03880422|Dietary Supplement|Dietary Intervention|Receive diet plan
15870121|NCT03880422|Other|Educational Intervention|Attend educational meeting
15870122|NCT03880422|Behavioral|Exercise Intervention|Complete exercise program
15870123|NCT03880422|Other|Quality-of-Life Assessment|Ancillary studies
15870124|NCT03880422|Other|Survey Administration|Ancillary studies
15870125|NCT03880409|Drug|2% lidocaine with 1:000,000 epinephrine|2% lidocaine with 1:000,000 epinephrine is dental local anesthesia
15870126|NCT03880409|Drug|4% articaine with 1:000,000 epinephrine|4% articaine with 1:000,000 epinephrine is dental local anesthesia
15870127|NCT03880396|Radiation|hypofractionated Rth with platinol|hypofractionated Rth with weekly cisplatin 40mg/m2
15870128|NCT03880383|Behavioral|Coaching|Parents will interact and communicate regularly with a coach in person or by telephone. Coaches will be responsible for: identifying developmental concerns, proactive health promotion, guidance and training for developmental stimulation, parent support and education about child development, navigation of the health care system and self-management techniques. The frequency of coaching will be: once a month (minimum), for 18 months, at an average of 2.5 hours per month.
15870129|NCT03880383|Behavioral|Online parent education|Parents will be provided access to an online platform which will provide educational resources and access to parent-parent support. Online resources on child development are curated by researchers and representative of parent groups, and linked to this online platform. The themes covered in the online tool include resources on child development, accessing health care services and managing emotions and family dynamics. These topics range from: practical tips for managing day-to-day challenges, strategies to cope and support the child's transitions from one stage to another, practical tips when looking for developmental services for the child: knowing where and how to access services.
15870130|NCT03880383|Behavioral|Online peer support|Parents will have access to a secure online social media tool to connect to other parents going through a similar experience. Through this tool, parents can help support each other, and share their experiences and knowledge. This will put each family at the centre of each network (family, friends, health providers), allowing family networks to link with one another. Families will be able to find resources, create connections with the coach, health providers and other families, thus creating a network to support one another.
15870131|NCT03880370|Behavioral|Questionnaires / scales|EVA, ROLAND MORRIS, OWESTRY and Global Questionnaire of Physical Activity (GPAQ)
15870132|NCT03880370|Diagnostic Test|Ultrasound imaging|Rectus abdominis dominant side & non-dominant side external oblique dominant side & non-dominant side internal oblique dominant side & non-dominant side transversus abdominis dominant side & non-dominant side lumbar multififidus l4-l5-s1 gluteus medius dominant side & non-dominant side
15870133|NCT03880370|Diagnostic Test|FLEXIBILITY|weight-bearing lunge hip lateral rotation straight leg raise fingertip to floor test
15870134|NCT03880370|Diagnostic Test|FUNCTIONAL TESTS|Star excursion balance test (sebt) prone bridging test Side bridging test Modified biering-sørensen
15870173|NCT03880058|Drug|Formulation buffer|Placebo treatment
15870135|NCT03880357|Drug|Betamethasone Scalp Suspension 0.064%;0.0005%|applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.
15870136|NCT03880357|Drug|Taclonex®|applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.
15870137|NCT03880357|Drug|Placebo topical suspension|applied once daily by gently rubbing to the affected area(s) of the scalp for approximately 4 weeks.
15870138|NCT03880344|Device|Vibration Therapy|Vibration therapy as a pre-operative rehabilitation programme 3 times a week for 3 months + Normal Regular out-patient department physiotherapy
15870139|NCT03880344|Combination Product|Physiotherapy|Physiotherapy as post-operative rehabilitation programme for 6 months.
15870140|NCT03880331|Procedure|Debridement|Aggressive vs Minimal Debridement
15870141|NCT03880318|Procedure|Joint Preserving Surgery in spasmodic flat foot|extensor digitorum longus, peroneus brevis and tertius lengthening together with calcaneal osteotomies
15870142|NCT03880305|Diagnostic Test|complete blood count|complete blood count
15870143|NCT03880292|Procedure|Document intraoperative Maneuvers|Monitoring procedure during surgery
15870144|NCT03880279|Biological|TAC01-CD19|Dose-escalating cohorts plus expansion groups
15870145|NCT03880266|Drug|Glycopyrronium cloth, 2.4%|Pre-saturated 100% polypropylene, nonwoven, fabric cloth with glycopyrronium
15870146|NCT03880266|Drug|Vehicle|Pre-saturated 100% polypropylene, nonwoven, fabric cloth
15870147|NCT03880253|Drug|CTP-692|Placebo or CTP-692
15870148|NCT03880240|Device|Transcranial Alternating Current Stimulation (tACS)|tACS is a non-invasive way of stimulating the brain externally using weak electric currents. Electrodes are placed into a cap that you wear on your head. A weak electrical current travels back and forth through the electrodes to your head. tACS will be applied at a frequency of 40Hz and targeting the area of maximal tracer uptake on amyloid PET imaging using an individualized multielectrode design to maximize the induced electrical current to the target region.
15870149|NCT03880240|Other|Sham Transcranial Alternating Current Stimulation|Placebo Control, simulation of transcranial alternating current stimulation without receiving any stimulation
15870150|NCT03880227|Device|Active anodal tDCS|active anodal tDCS with behavioral tasks to assess visual attention
15870151|NCT03880227|Device|Sham tDCS|sham tDCS with behavioral tasks to assess visual attention
15870152|NCT03880201|Procedure|ultrasound guided supraclavicular block|"The linear transducer will be applied firmly above the clavicle in the coronal oblique plane the 22-gauge needle will be inserted at the lateral side of the ultrasound probe using In-plane approach. The needle will be advanced towards the target nerves inferior, lateral and superficial to subclavian artery respectively. Local anesthetic solution is injected between 20 to 25 ml.
~Motor block will be assessed as follow Radial nerve = Push the arm by extending the forearm at the elbow against the resistance, musculocutaneous nerve = Resisting the pull of the forearm at the elbow, median nerve = Thumb and second digit pinch, ulnar nerve = Thumb and fifth digit pinch.
~Sensory block will be assessed by using piece of ice in the distribution of median, ulnar, radial and musculocutaneous nerves."
15870153|NCT03880201|Device|Masimo SET pulse oximetry (Masimo Corporation, Irvine, CA, USA)|Masimo reading of PI values will be recorded every minute (at both index and fifth digits) for 20 minutes then every 3 minutes for 30 minutes.
15870154|NCT03880175|Behavioral|FCC (Força à Comunidade e Crianças) program- direct beneficiary|Households are directly linked to the FCC implementing organization
15870155|NCT03880175|Behavioral|FCC (Força à Comunidade e Crianças) program- non-direct beneficiary|Households live in FCC implementing communities but are not directly linked to the FCC implementing organization
15870156|NCT03880175|Behavioral|Anti Stigma Information|Adults in the households are provided anti-stigma information
15870157|NCT03880175|Behavioral|HIV/AIDS Information|The households receive information about HIV infection and AIDS
15870158|NCT03880175|Behavioral|ART Information|The households receive information about antiretroviral therapy.
15870159|NCT03880175|Behavioral|HIV/AIDS and ART Information Combined|The households receive both information about HIV/AIDS and information about antiretroviral therapy.
15870160|NCT03880175|Behavioral|High coupon value|The HIV testing coupons distributed to households in this group have higher values.
15870161|NCT03880162|Other|Low carbohydrate diet|A energy deficient (30% deficit) low carbohydrate diet (10% of carbohydrates)
15870162|NCT03880162|Other|Energy-matched standard diet|Energy-matched (30% deficit) standard diet (50% of carbohydrates)
15870163|NCT03880149|Dietary Supplement|Omega-3|Each omega-3 capsule contains 600 mg, including 400 mg EPA + 200 mg Docosahexaenoic acid (DHA) and 400 IU of vitamin E for 5 omega-3 capsules. Omega-3 dosage: 1 g per 15 kg body mass
15870164|NCT03880149|Other|Placebo|Medium-chain triglyceride (MCT) and vitamin E
15870165|NCT03880136|Drug|CTP-543|Once daily dosing
15870166|NCT03880123|Drug|Selinexor|"Selinexor will be taken orally on Days 1, 8, 15, and 22 of each cycle at the following dose levels (DLs):
~DL 1: 40 mg; DL 2: 60 mg; DL 3: 80 mg; DL 4: 100 mg
~The selinexor product is provided as 20 mg tablets in wallet-sized blister packs. Selinexor should be taken together with ixazomib."
15870167|NCT03880123|Drug|Ixazomib|"Ixazomib will be taken orally on Days 1, 8, and 15 of each cycle at the same dose level: 4 mg.
~The ixazomib product is provided in strengths of 4.0, 3.0, and 2.3 mg capsules as the active boronic acid. Ixazomib should be taken on an empty stomach (no food or drink) at least 1 hour before or at least 2 hours after food."
15870168|NCT03880097|Procedure|Research Biopsy|"The Research Biopsy is a biopsy in addition to the standard of care biopsies that the patient will have to inform their diagnosis. The actual procedure is not any different to the standard per-cutaneous biopsy, this is just an additional procedure, solely for research purposes."
15870169|NCT03880084|Other|Observation|To systematically assess the onset of delirium, quantify the level of agitation/sedation, estimate the grade of pain and survey the level of dyspnea in patients undergoing non invasive mechanical ventilation
15870170|NCT03880071|Behavioral|DBT+ACT|- The experimental group (DBT+ ACT) will have: 25 therapy group sessions (1 sessions of 2 hours once a week) 25 individual interview sessions (1 sessions of 1 hour once a week) will receive 25 group sessions and 25 individual ones during 6 months.
15870171|NCT03880071|Behavioral|DBT|"The control group (DBT) will have:
~50 therapy group sessions (1 session of 2h30 once a week) 50 individual interview sessions (1 sessions of 1 hour once a week)"
15870172|NCT03880058|Drug|SLI-F06|Active treatment
15870174|NCT03880045|Drug|Topical TA|A gauze soaked with 2 g tranexamic acid (20 ml) diluted in 100 ml of sodium chloride0.9%
15870175|NCT03880045|Drug|vasopressin|intraoperative perivascular injection of one ampoule of vasopressin containing 20 units in 1 ml after dilution in 19 ml of normal saline during myomectomy
15870176|NCT03880045|Other|placebo to TA|(120 ml of sodium chloride 0.9%) used to compress the myoma bed for 5 min.
15870177|NCT03880032|Behavioral|Cognitive Behavioral Therapy Intervention for Anxiety|Happy Mother Healthy Baby (HMHB) is a CBT-based psychosocial intervention for expectant women experiencing anxiety during their pregnancy. Strategies such as empathetic listening, thought challenging, behavior activation, problem management, take-home exercises, and family involvement are employed by HMHB.
15870180|NCT03880006|Behavioral|Case management|Case management intervention is a multi-step process to coordinate care and provide a family-like support system for people living with HIV. Individuals are assigned to a specific case manager who will provide support throughout the study. The case management approach has five key components: 1) initial meeting between person living with HIV and case manager; 2) follow up meeting between case manager and participant; 3) biweekly automatic text messages sent to participant; 4) monthly phone calls from case manager; and 5) face-to-face meetings between case manager and participant every 6 months.
15870181|NCT03879993|Other|Exercise group|Resistance training 3 times per week (45-60 minutes of resistance training)
15870182|NCT03879980|Drug|Bilateral QL block|Bilateral lateral Quadratus Lumborum block using 20 ml of 0.25% bupivacaine each injection as preemptive analgesia.
15870183|NCT03879980|Drug|Non-QL block|Only received fentanyl IV during surgery.
15870184|NCT03879967|Device|Allograft block graft|The graft used is a mineralized, cortico-cancellous, delipidized, lyophilized allogenic block.
15870185|NCT03879954|Device|Catetherization approach|Out of plane inetrnal jugular vein Vs in plane supraclavicular subclavian vein catetherization
15870186|NCT03879928|Drug|Single ascending doses of FM101|The study drug (FM101 and placebo comparator) will be administered orally as SAD doses
15870187|NCT03879928|Drug|Multiple ascending doses of FM101|The study drug (FM101 and placebo comparator) will be administered orally as MAD doses
15870188|NCT03879928|Drug|Food effects of FM101|The study drug (FM101) will be administered orally under fasted condition and fed condition.
15870189|NCT03879915|Procedure|Dental Implant placement|Surgical placement of dental implant not associated with prior or concurrent bone augmentation
15870190|NCT03879889|Drug|Nicotine patch|Four weeks of nicotine patch will be provided at the first contact, which will be prescribed using the guidelines based on the subject's daily cigarette consumption. At week-4 visit, four more weeks of NRT will be provided.
15870191|NCT03879876|Drug|Human T Lymphoid Progenitor (HTLP) injection|Injection of progenitors derived from HTLP culture at Day 8-Day 12 after partially HLA compatible allogeneic hematopoietic stem cell transplantation in SCID patients (Day7 of culture)
15870192|NCT03879863|Drug|Reproxalap Ophthalmic Solution (0.25%) QID|Reproxalap Ophthalmic Solution (0.25%) administered QID for twelve weeks
15870193|NCT03879863|Drug|Vehicle Ophthalmic Solution QID|Vehicle Ophthalmic Solution administered QID for twelve weeks
15870194|NCT03879863|Drug|Reproxalap Ophthalmic Solution (0.25%) QID to BID|Reproxalap Ophthalmic Solution (0.25%) administered QID for four weeks, followed by BID administration for eight weeks
15870195|NCT03879863|Drug|Vehicle Ophthalmic Solution QID to BID|Vehicle Ophthalmic Solution administered QID for four weeks, followed by BID administration for eight weeks
15870196|NCT03879837|Drug|Fluticasone propionate pressurized metered dose inhaler|110 mcg per actuation
15870197|NCT03879837|Drug|Flovent HFA pressurized metered dose inhaler|110 mcg per actuation
15870198|NCT03879837|Drug|Placebo pressurized metered dose inhaler|no active content
15870199|NCT03879824|Procedure|Secondary Radial Artery Access|Patients undergoing transcatheter aortic valve implantation (TAVI) will receive secondary arterial access via percutaneous access of the right radial artery for the purpose of insertion of a standard pigtail catheter for aortic route angiography during TAVI.
15870200|NCT03879824|Procedure|Secondary Femoral Artery Access|Patients undergoing transcatheter aortic valve implantation (TAVI) will receive secondary arterial access via percutaneous access of the contralateral femoral artery for the purpose of insertion of a standard pigtail catheter for aortic route angiography during TAVI.
15870201|NCT03879811|Drug|TMZ|Oral TMZ at 150mg/m2
15870202|NCT03879811|Drug|Nivolumab|Nivolumab via IV infusion at 480 mg every four weeks (Q4W) starting 4 weeks after TMZ day 1
15870203|NCT03879798|Drug|DS-3201b|100 mg daily
15870204|NCT03879798|Drug|irinotecan|Irinotecan 125 mg/m^2 intravenously on days 1 and 8 every 3 weeks in a 21-day cycle.
15870205|NCT03879785|Other|Screening|Screening and validation of assessment tool translated into Spanish
15870206|NCT03879772|Drug|Mometasone furoate nasal spray|intranasal administration
15870207|NCT03879772|Drug|Beclomethasone dipropionate nasal spray|intranasal administration
15870208|NCT03879772|Drug|Placebo nasal spray|intranasal administration
15870209|NCT03879772|Drug|Chlorpheniramine maleate syrup|oral administration
15870210|NCT03879759|Drug|NAC 2400mg/day|2400mg/day 2 x 600mg b.d
15870211|NCT03879759|Drug|Placebo|4 matched placebo tablets/day
15870212|NCT03879746|Drug|Tamsulosin|drug will be used in treatment of premature ejaculation
15870213|NCT03879746|Drug|Paroxetine Hydrochloride|drug will be used in treatment of premature ejaculation
15870214|NCT03879746|Other|placebo|tablets without active substance will be given to patients suffering from premature ejaculation
15870215|NCT03879733|Behavioral|Thrive by Three|"The intervention consists of the following components:
~Measurement of daycare quality with CLASS (Classroom Assessment Scoring System) 3 times during the intervention period
~Feedback to group staff on 8 CLASS-quality dimensions
~Monthly supervision of staff on two levels: supervision of daycare staff, and supervision of supervisors
~Competence building with all staff: 3 full training days, plus 2 extra training days for pedagogical leaders/supervisors
~Written material to parents, supervisors, and staff
~Web page for staff and parents: tf3.no"
15870250|NCT03879512|Biological|cancer vaccine|4 weekly intradermal injections of lysate-loaded dendritic cells, followed by 3 monthly boost vaccines with tumor lysate and further boost vaccines every three months
15870216|NCT03879733|Behavioral|Treatment as usual (TAU)|The wait-list control group will continue with their daily activities and work in the childcare as usual. The wait list control group will have received general information about the study prior to consenting, however no materials or are provided by project. The child-care centers in the control conditions will receive a gift certificate of 3000 Norwegian Crones (NOK) by the end of the intervention period.
15870217|NCT03879720|Procedure|Endoscope assisted endotracheal intubation [EAEI]|Endoscope assisted endotracheal intubation [EAEI] performed by anesthesiologist with endoscopist assistance.
15870218|NCT03879707|Drug|Melatonin 5 mg|Melatonin is known to induce sleep
15870219|NCT03879707|Drug|Placebo Oral Tablet|Placebo
15870220|NCT03879707|Drug|Magnesium 500Mg Oral Tablet|Magnesium plays a role in supporting deep, restorative sleep by maintaining healthy levels of GABA, a neurotransmitter that promotes sleep. Research indicates supplemental magnesium can improve sleep quality, especially in people with poor sleep
15870221|NCT03879694|Biological|Incomplete Freund's Adjuvant|Given SC
15870222|NCT03879694|Drug|Octreotide Acetate|Given IM
15870223|NCT03879694|Biological|Sargramostim|Given SC
15870224|NCT03879694|Biological|SVN53-67/M57-KLH Peptide Vaccine|Given SC
15870225|NCT03879681|Dietary Supplement|Jelly confectionary Snakes|"The participants will be randomized by computer generated randomisation to receive either the jelly snake (n=120) or no intervention (n=120) apart from standard institutional management.
~All children randomised into the snake group will be offered a chewy jelly snake once alert and cooperative in PACU or on the ward once University of Michigan Sedation Scale (UMSS) is 025,26. The UMSS is a simple observational tool that assesses the level of alertness on a five-point scale ranging from 1 (wide awake) to 5 (unarousable with deep stimulation).
~The children randomized into the control group will receive a chewy jelly snake as a treat at discharge."
15870226|NCT03879668|Device|eIPOS|Electronic version of IPOS
15870227|NCT03879655|Drug|VTS-270|Lumber intrathecal infusion of VTS-270
15870228|NCT03879642|Behavioral|REDCHiP|10 week video-based telemedicine intervention to reduce hypoglycemia fear
15870229|NCT03879629|Drug|Carvedilol|oral Carvedilol maximally tolerated doses 3.125 mg to 25 mg twice a day
15870230|NCT03879616|Behavioral|An Enhanced Reminder|"This study will be a randomized trial over a 6-month period (March 8 through September 7, 2019) in 3 GI endoscopy clinics (Franklin, Rock Creek, and Lone Tree). All members currently receive a text reminder 7 days prior to their procedure, which rolls over to a telephone reminder if the text cannot be delivered or the member's phone is not text-enabled. Members will be randomized either to receive this standard IVR-T protocol (control) or to receive an enhanced reminder (intervention) protocol.
~Data from the randomized trial, for both intervention and control participants, will be analyzed to develop a statistical prediction rule that identifies members at highest risk of missing their procedure."
15870231|NCT03879603|Biological|VRC-WEVVLP073-00-VP|VRC-WEVVLP073-00-VP is composed of 1:1:1 ratio of WEE, EEE, and VEE virus-like particles (VLP)
15870232|NCT03879603|Other|VRC-GENMIX083-AL-VP|VRC-GENMIX083-AL-VP is an adjuvant
15870233|NCT03879590|Drug|Doxophylline|Both groups will receive doxophylline one group will maintain the ICS dose and the other group will receive a reduced ICS dose (Maintaining the same GINA treatment step). After 4 weeks both groups will interchange treatment scheme.
15870234|NCT03879590|Drug|Budesonide|Both groups will receive doxophylline one group will maintain the ICS dose and the other group will receive a reduced ICS dose (Maintaining the same GINA treatment step). After 4 weeks both groups will interchange treatment scheme.
15870235|NCT03879577|Drug|Docetaxel|Administered to all patients for a minimum of 4 cycles for 12 weeks.
15870236|NCT03879577|Drug|Herceptin|Administered for 18 cycles every three weeks (52 weeks) for each patient starting at the first day of treatment with docetaxel.
15870237|NCT03879577|Drug|FEC|Only administered to patients who received docetaxel and herceptin and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable).
15870238|NCT03879577|Drug|Tamoxifen|Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole.
15870239|NCT03879577|Drug|Letrozole|Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole.
15870240|NCT03879577|Drug|LHRH agonist|Administered to all premenopausal patients.
15870241|NCT03879564|Drug|Ketamine|ketamine in NSS (1 mg/ml) IV bolus 0.3 ml/kg then drip 0.09 ml/kg/hr
15870242|NCT03879564|Drug|Normal saline|NSS IV bolus 0.3 ml/kg then drip 0.09 ml/kg/hr
15870243|NCT03879551|Device|repetitive Transcranial Magnetic Stimulation|By defining intensity of 80% of the resting Motor Threshold detected from motor area for Rt Abductor digiti minimi (ADM), we will apply repetitive Transcranial Magnetic Stimulation (rTMS) using 70-mm diameter air-cooled figure-of-8 coil and SuperRapid2 Magnetic Stimulator with high frequency (25Hz), Stimuli will be delivered for total 2000 pulse (divided on 50 trains with 40 pulses per train with inter-train interval 30 seconds) for each hemisphere (coil placed tangential over the optimal position of hand motor area detected for Real group and the same coil placed perpendicular with hand of coil pointing upward over occipital cortex for Sham group). Sessions will be consecutive for ten days period with repetition of consecutive 5 sessions as boosting doses on 5 days period over the follow up visits every month for the next 3 months.
15870244|NCT03879538|Drug|Nitrous Oxide|a total of three treatments (6 total exposure hours) over one week with 2 or 3 days between each session.
15870245|NCT03879538|Drug|Oxygen|a total of three treatments (6 total exposure hours) over one week with 2 or 3 days between each session.
15870246|NCT03879525|Other|EMR-based-interventional method|Questionnaire delivery method. Participants will complete standard care anxiety and depression screening and quality of life assessment directly into the patient entered section of the EMR, administered on arrival in the clinic.
15870247|NCT03879525|Other|Telephone-based-standard method|Questionnaires delivered via phone. Participants will complete standard care anxiety and depression screening and quality of life assessment via phone. Standart delivery method.
15870248|NCT03879512|Drug|depletion of regulatory T cells|oral metronomic cyclophosphamide
15870249|NCT03879512|Procedure|reoperation|resection of relapsed tumor in order to improve clinical condition of the patient and to acquire tumor tissue for vaccine generation
15870251|NCT03879512|Biological|checkpoint blockade|Immediately one week after the DC-induction vaccines, patients will receive four applications of Nivolumab/Ipilimumab double checkpoint blockade in threeweekly intervals, followed by Nivolumab monotherapy every month for a total duration of one year.
15870252|NCT03879486|Other|Intrarectal povidone-iodine cleansing plus formalin disinfection of needle tip during transrectal ultrasound guided prostate biopsy|The examiner will use a gauze soaked and saturated with iodopovidone and perform a mechanical friction motion on the anterior wall of the rectum, at least 5 times from one margin to another of the prostate laterally-laterally. A period of two (2) minutes shall be waited from the prophylactic cleaning of the rectum to the beginning of the biopsy. The examiner will use a technique of disinfecting the 10% formaldehyde biopsy needle without manual contact by soaking the distal 3 cm of the needle directly into a vial containing the bactericidal solution between obtaining the different fragments. An individual bottle will be used for each patient
15870253|NCT03879460|Drug|Naltrexone Hydrochloride|50 mg per os naltrexone hydrochloride
15870254|NCT03879447|Drug|Herbal medicine|Herbal medicine will be administered in water-based decoction (120ml) and dried powder (2g) form (Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, Saposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycine max, Atractylodes japonica) at the physician's discretion.
15870255|NCT03879447|Procedure|Chuna manual medicine|Chuna is a Korean manual therapy directed at the spine and joints that incorporates various spinal manual medicine techniques for joint mobilization involving high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement. Chuna manual medicine will be administered to the pelvic, lumbar, thoracic, and cervical vertebrae at the physician's discretion.
15870256|NCT03879447|Procedure|Bee venom pharmacopuncture|Bee venom pharmacopuncture will be administered only after confirming a negative response to hypersensitivity skin test. Diluted bee venom (saline:bee venom ratio, 10,000:1) filtered for allergens will usually be injected at 4-5 acupoints proximal to the dysfunctional site at the physician's discretion. Each acupuncture point will be injected to a total of 0.5-1 cc using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
15870257|NCT03879447|Procedure|Pharmacopuncture|Pharmacopuncture consisting of select herbal ingredients will be administered at Hyeopcheok (Huatuo Jiaji, EX B2), Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea) at the physician's discretion.
15870258|NCT03879447|Procedure|Acupuncture|Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
15870259|NCT03879447|Procedure|Electroacupuncture|Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
15870260|NCT03879447|Procedure|Cupping|Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.
15870261|NCT03879447|Procedure|Other intervention(s)|Patients will be allowed any other additional intervention(s) as deemed necessary regardless of type or dose, and patterns of use will be investigated and recorded as a pragmatic clinical study.
15870262|NCT03879434|Device|Ostenil® Mini|Ostenil® Mini is a CE-certified viscoelastic solution for injection into the Joint cavity, containing 1.0 % sodium hyaluronate from fermentation
15870263|NCT03879421|Procedure|Accelerated corneal collagen cross linking|This strategy is based on the underlying pathology of the disease. Corneal collagen cross linking (CXL) idea was based on the fact that a photosensitizer substance like riboflavin (vitamin B2) can interact with ultraviolet irradiation (Ultraviolet-A) to strengthen the corneal tissue inter and intrafibrillar collagen bonds thus preventing further thinning, corneal protrusion and reduces corneal irregular astigmatism.
15870264|NCT03879408|Drug|440 mg naproxen sodium with 1000 mg acetaminophen|440 mg naproxen sodium with 1000 mg acetaminophen administered as a single dose of two naproxen sodium 220 mg tablets and two acetaminophen 500 mg tablets
15870265|NCT03879408|Drug|220 mg naproxen sodium with 650 mg acetaminophen|220 mg naproxen sodium with 650 mg acetaminophen administered as a single dose of one naproxen sodium 220 mg tablet and two acetaminophen 325 mg tablets and one placebo tablet
15870266|NCT03879408|Drug|10 mg hydrocodone + 650 mg acetaminophen|10 mg hydrocodone with 650 mg acetaminophen administered as a single dose of two hydrocodone 5 mg + acetaminophen 325 mg tablets and two placebo tablets
15870267|NCT03879408|Drug|440 mg naproxen sodium|440 mg naproxen sodium administered as a single dose of two naproxen sodium 220 mg tablets and two placebo tablets
15870268|NCT03879408|Drug|Placebo tablet|Single dose of four placebo tablets
15870269|NCT03879395|Procedure|Abdominal surgery with metastasectomy|Emergency or elective surgery on indications related to abdominally metastasized malignant melanoma
15870270|NCT03879382|Biological|anti-CD19/BCMA CAR-T cells|Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-BCMA CARs
15870271|NCT03879382|Drug|Fludarabine|30mg/m2/d
15870272|NCT03879382|Drug|Cyclophosphamide|300mg/m2/d
15870273|NCT03879369|Diagnostic Test|Hormonal assay|LH , FSH and Free testosterone index (FTI) levels
15870274|NCT03879356|Drug|N-acetyl cysteine|effect of N-acetyl cysteine in Aluminum phosphide poisoning patients
15870275|NCT03879343|Other|Known diagnosis of attention deficit / hyperactivity disorder|Clinical group includes subjects with clinical diagnosis of attention deficit / hyperactivity disorder
15870276|NCT03879330|Device|NIRS monitoring|aSAH patients will be given continuous NIRS and blood pressure monitoring at same time. The correlation curve between the brain oxygenation index or the brain hemoglobin index (ORI/THx) and the blood pressure will be obtained through continuous monitoring of 4 hours. According to the correlation curve, the optimal blood pressure will be determined which provides the optimal CPP.
15870277|NCT03879317|Device|Continuous NIRS monitoring|Septic shock patients who have continuous NIRS and blood pressure monitoring at same time will be included. The correlation curve between the brain oxygenation index or the brain hemoglobin index (ORI/THx) and the blood pressure will be obtained. According to the correlation curve, the optimal blood pressure will be determined which provides the optimal CPP.
15871918|NCT03866824|Drug|injection of corticosteroids|intra-articular injection
15870280|NCT03879291|Other|pinpointIQ|The study will utilize physIQ's multivariate analytical methods that detect vital sign relationship changes compared to a patient's individual baseline. Changes in vital signs relationships may be indicative of current or future important clinical events. These changes are indicated through the Multivariate Change Index (MCI), which is a scalar index between 0 and 1, where values close to 0 indicate no significant change from baseline and values close to 1 indicated greater changes from baseline
15870281|NCT03879278|Drug|NPT189|NPT189 is a recombinant immunoglobulin Fc fusion of GAIM (GAIM-IgG1Fc) as a potential treatment for peripheral amyloidosis.
15870282|NCT03879265|Diagnostic Test|Noninvasive chromosome screening|Screening based on MALBAC-NGS technology
15870283|NCT03879252|Device|Toothbrush|Brushing teeth three times a day (extra-soft toothbrush) with a 1.4% baking mouthwash solution.
15870284|NCT03879252|Drug|Mouthwashes|Mouthwashes three times a day with a 1.4% baking mouthwash solution.
15870285|NCT03879239|Device|Vibrating capsule|Vibrating Capsule administered 5 times per week
15870286|NCT03879226|Device|PBMT|PBMT will be applied bilaterally using the direct contact method with light pressure on the skin at different sites, namely 9 sites on the knee extensor muscles, 6 sites on the knee flexor muscles, and 2 sites on the plantar flexor muscles. A 12-diode cluster, with 4 905-nm laser diodes (12.5W peak power for each diode), 4 875-nm LED diodes (17.5 mW mean power for each diode), and 4 640-nm LED diodes (15 mW mean power for each diode), manufactured by Multi Radiance Medical® (Solon, OH, USA), will be used to apply the PBMT. The dose used for the applications during the training and/or detraining periods will be 30 Joules (J) per site (510 J per lower limb). PBMT will be applied before and after each training session and during the detraining period, depending on the group to which the volunteers are allocated.
15870287|NCT03879226|Device|Placebo|Placebo will be applied bilaterally using the direct contact method with light pressure on the skin at different sites, namely 9 sites on the knee extensor muscles, 6 sites on the knee flexor muscles, and 2 sites on the plantar flexor muscles. The placebo PBMT will per performed using the dose of 0 J per diode. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (active or placebo). Placebo will be applied before and after each training session and during the detraining period, depending on the group to which the volunteers are allocated.
15870288|NCT03879213|Dietary Supplement|Active breakfast|freeze-dried red raspberry powder (12.5 g) in drink+ freeze-dried red raspberry powder (12.5 g) in buttermilk biscuit sandwich
15870289|NCT03879213|Dietary Supplement|Control breakfast|Control drink + buttermilk biscuit sandwich
15870290|NCT03879200|Other|Group antenatal care|Care will be provided in group sessions in dialogue sensitive to language and cultural issues. Group numbers will be around 8; the woman with partner or other companion welcome. The content of the sessions will be designed in collaboration with midwives and Somali born women, following the present parental education and findings from the focus groups. The sessions will be held at the antenatal clinic led by one or two midwife, assisted by the trained female Somali interpreter.
15870291|NCT03879187|Dietary Supplement|High-fat, high-energy diet|Participants consumed a diet that was high in fat and high in energy
15870292|NCT03879174|Drug|Pembrolizumab + Tamoxifen|"The choice of the 200 mg Q3W as an appropriate dose for the switch to fixed dosing is based on simulations performed using the population PK model of pembrolizumab showing that the fixed dose of 200 mg every 3 weeks will provide exposures that 1) are optimally consistent with those obtained with the 2 mg/kg dose every 3 weeks, 2) will maintain individual patient exposures in the exposure range established in melanoma as associated with maximal efficacy response and 3) will maintain individual patients exposure in the exposure range established in melanoma that are well tolerated and safe.
~A fixed dose regimen will simplify the dosing regimen to be more convenient for physicians and to reduce potential for dosing errors. A fixed dosing scheme will also reduce complexity in the logistical chain at treatment facilities and reduce wastage."
15870294|NCT03879148|Other|Erector spinae plane block|Erector spinae plane block was performed to the patients under aseptic conditions
15870295|NCT03879135|Biological|rVWF|Recombinant von Willebrand factor
15870296|NCT03879135|Biological|rFVIII|Recombinant Factor VIII
15870297|NCT03879122|Drug|Ipilimumab 5 MG/ML|Ipilimumab will be administered on day 1 of each cycle every 3 weeks. In arm 3, ipilimumab should be started at least 2 weeks but no later than 120 days after surgical castration or the first dose of LHRH analogue. Patients should receive 2 doses of ipilimumab (6 weeks). It will be followed, 3 weeks later, by 3 cycles of docetaxel and by 2 additional doses of ipilimumab and 3 more cycles of docetaxel. Four weeks later, Nivolumab will be administered on day 1 every 2 weeks until a maximum of 24 doses (48 weeks)
15870298|NCT03879122|Drug|Nivolumab 10 MG/ML|Nivolumab will be administered every 2 weeks, until clinical progression or a maximum of 24 doses. Nivolumab should be started 4 weeks after the last dose of docetaxel, providing all the adverse effects have recovered, as if a new cycle of docetaxel were to be administered
15870299|NCT03879122|Drug|Docetaxel|"Docetaxel should be given on day 1 every 21 days, for up to 6 cycles (1 cycle = 21 days). Docetaxel should be started within 7 working days from the date of randomization in the arm 1 and 2.
~In arm 3, docetaxel will be given 3 weeks after the last dose of the previous treatment, providing all the side effects are grade ≤1."
15870300|NCT03879122|Drug|ADT (androgen deprivation therapy)|Androgen deprivation therapy per the standard of care
15870301|NCT03879109|Drug|Chemotherapy FOLFIRINOX, 6 cycles|"oxaliplatin: 85 mg/m2
~irinotecan: 180 mg/m²
~folinic acid: 400 mg/m2
~5FU : 400 mg/m2 (bolus)
~5FU : 2400 mg/m2 (continuous infusion)"
15870302|NCT03879109|Radiation|Radiochemotherapy|Reirradiation consists in conformational intensity modulated external irradiation (Intensity-modulated radiotherapy Volumetric Modulated Arc Therapy or tomotherapy) delivering a 30.6 Gy dose with high-energy photons in fractions of 1.8 Gy per day (17 fractions) 5 days a week With Concomitant chemotherapy including Capecitabine 1600 mg/m²/day, five days a week.
15870303|NCT03879109|Procedure|Surgery|"Surgery will be performed at:
~Arm A: 8 weeks (±1) after the end of treatment
~Arm B: 6 weeks (±1) after the end of treatment
~Surgical procedures are defined into three categories:
~Total mesorectal excision (TME)
~Extended-TEM (e-TME)
~Pelvic exenteration (PE)"
15870323|NCT03878901|Combination Product|low risk warm|30 min prewarming The Bair HuggerTM Forced-air Warming System and cotton blanket warming through operation
15870304|NCT03879096|Other|Therapeutic Exercise and Education|Intervention will consisted of 30 minutes of strength exercises followed by 20 minutes of endurance with aerobic training, individualised based on the evaluations of muscular strength and endurance as well as the determination of the aerobic-anaerobic zone transition. Sessions lasted 1 hour, carried out twice a week, during 12 weeks. This intervention will be complemented by nutritional education.
15870305|NCT03879083|Other|Addition of palatal rugae to the complete denture surface|The addition and reproduction of the patient's own palatal rugae to the complete maxillary denture palatal surface.
15870306|NCT03879083|Other|The removal of the palatal rugae from the complete denture surface|The removal of the palatal rugae from the complete maxillary denture palatal surface to become a smooth surface
15870307|NCT03879070|Device|Ankle active and passive mobilization using an Ankle mobilization device|The treatment consists in 20 rehabilitation sessions, 5 times/week for 4 weeks. The device is capable of generating ankle dorsi/plantarflexion movements using two activation modes: passive and assistive. In the passive mode the device generates a movement pattern which the patient follows passively without exerting any force on the device. During the assistive mode, the device follows the active movement of the patient. During the intervention, these two modes will be alternated.
15870308|NCT03879057|Drug|Surufatinib/humanized anti-PD-1 monoclonal antibody|humanized anti-PD-1 monoclonal antibody(JS001) is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with th combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activitation of lymphocytes and elimination of malignancy theoretically.
15870310|NCT03879031|Diagnostic Test|Cluster of Clinical tests to measure lumbar stability|"All subjects will be submitted to a cluster of clinical test before the starting of the first session, and at the ending of the last session of the physical therapy program. This cluster will include:
~Aberrant Movements (AM) Test,
~Active Straight Leg Raise Test (ASLR) Test,
~Supine Bridge Test (SuBT),
~Right Side Bridge Test (RBT),
~Left Side Bridge Test (LBT),
~Prone Bridge Test (PrBT),
~Passive Lumbar Extension (PLE) Test,
~Prone Instability Test (PIT)."
15870311|NCT03879018|Behavioral|Reach training with visual feedback|Reach training will be accomplished using an Oculus Rift and Touch 3D headset. Active markers will be placed on the shoulder, elbow, wrist, and finger in order to capture limb movement in real time. During each training session, participants will first be familiarized with the task and then will reach from a home position to 4 virtual targets that are presented in the front of the participant and within the workspace where most natural arm movements are performed.Targets will be presented in a pseudorandom order and participants will reach a total of 400 times
15870312|NCT03879005|Other|renal scintigraphy|"99mTc-DTPA Scintigraphy Five mci of 99mTc-DTPA will be injected by IV route together with diuretic. Dose will be adjusted according to the age and weight of the patients. A total of 20 min dynamic imaging followed by calculation of GFR and SRF according to the built-in processing protocol Gate's method.
~99mTc-DMSA scintigraphy Five mci of 99mTc- DMSA will be injected by IV route with adjustment according to age and weight. Static images will be acquired in the posterior, anterior, andposterior oblique projections for 60 s each."
15870313|NCT03878992|Drug|Genotropin miniquick 0.5 mg, injection|GH will be given as an injection. Muscle biopsy will be obtained from m. vests laterals of the dominant leg. Fat biopsies will be obtained from subcutaneous abdominal fat. Tracers will be given as a bolus followed by continuous infusion for 6 hours. For palmitate tracer the infusion will be for only 1,5 hours followed by a one hour break and then another 1 hour infusion. Blood tests will be drawn from a venous catheter placed on the dorsal side of the hand.
15870314|NCT03878979|Drug|Nivolumab 480mg and surgical resection|One dose of Nivolumab 480mg given four weeks prior to surgical resection.
15870315|NCT03878966|Device|Inserting polymer free drug eluting stent in the coronary arteries|• Early invasive strategy with percutaneous coronary intervention will be done for the patients presenting with NST ACS who meet the inclusion criteria using Polymer-free drug eluting stents instead of the polymer-permanent drug eluting stents .
15870316|NCT03878953|Drug|rhPTH(1-84)|Participants will receive a SC injection of initial dose of 50 mcg of rhPTH(1-84) once daily (QD) in the thigh (alternate thigh every day). If albumin-corrected serum calcium (ACSC; [mg/dL] = serum calcium [mg/dL] +0.8*[4-serum albumin (g/dL)]) is >2.25 mmol/L (>9.0 mg/dL), a starting dose of 25 mcg will be considered. At 4 week intervals the rhPTH(1-84) dose may be increased in 25 mcg increments to a maximal dose of 100 mcg SC QD. At any time during the study as needed for safety reasons, rhPTH(1-84) doses may be decreased in 25 mcg decrements to a minimum of 25 mcg QD. If the ACSC is >2.97 mmol/L (>11.9 mg/dL), then the investigational product should be stopped until the calcium level is corrected.
15870317|NCT03878940|Diagnostic Test|Abdominal ´yes-no´ pathway|A set of blood samples, a FIT, and an abdominal US (and a TVUS in women)
15870318|NCT03878927|Drug|CPX-351|CPX-351 is a liposomal formulation of a fixed combination of the antineoplastic drugs cytarabine and daunorubicin. The two drugs are present inside the liposome in a 5:1 molar ratio. The liposome membrane is composed of distearoylphosphatidylcholine, distearoylphosphatidylglycerol and cholesterol in a 7:2:1 molar ratio.
15870319|NCT03878927|Drug|Gemtuzumab Ozogamicin|Gemtuzumab ozogamicin is a CD-33 directed antibody drug conjugated to calicheamicin. CD 33 is expressed on myeloid leukemic blast cells and on normal hematopoietic cells. The drug is approved for the treatment of newly diagnosed CD 33 positive AML in adults and the treatment of relapsed and refractory CD 33 positive AML in adults. The drug is available for injection 4.5 mg as a lyophilized cake or powder in a single use vial for reconstitution and dilution.
15870320|NCT03878914|Drug|Corticosteroids|Patients will be divided into two groups based on time to remission with initial standard dose of corticosteroids. Patients who respond within 10 days (Group A) will receive a total of 8 weeks of corticosteroid therapy whereas those who respond between 10 days to 28 days (Group B) will receive ≥12 weeks ((maximum of 16 weeks) of corticosteroid therapy.
15870321|NCT03878901|Combination Product|high risk warm|Bair HuggerTM Forced-air Warming System to 30min pre- and entire operation warming, combined fluid warming
15870322|NCT03878901|Combination Product|moderate risk warm|30 min prewarming The Bair HuggerTM Forced-air Warming System cotton blanket warming and fluid warming through operation
15870324|NCT03878901|Other|passive warming|cotton blanket warming through operation
15870325|NCT03878888|Drug|Exparel 266 MG Per 20 ML Injection|patients receive Exparel in bilateral TAP blocks for open abdomen surgery
15870326|NCT03878875|Diagnostic Test|Session One Test Battery|"Prior to noise exposure:
~Test battery - High-frequency audiometry, Distortion Product Otoacoustic Emissions, Middle Ear Muscle Reflex, Speech-in-Noise test, Tinnitus Functional Index (Around 35 minutes with breaks if required)
~Extended Frequency Audiometry (~ 8 min): Participants will be asked to press the button when they hear a sound through the headphones in a soundproof booth.
~DPOAE (~ 5 min): A small tip will be placed in participants' ear and they will hear a sound. The tip measures a response from hair cells in the cochlea and they will not need to do anything.
~MEMR (~ 8 min): A small tip placed in both ears and again a sound heard, however, this sound will gradually get louder until an involuntary muscle reflex is noted.
~Speech-in-Noise Test (~ 5 min): Participants asked to repeat back a list of words as best as they can.
~TFI (~ 8 min): Participants given a self-report sheet in which they have to fill out aspects of any tinnitus experienced."
15870327|NCT03878875|Diagnostic Test|Session Two Test Battery|"Exposure at single loud music event (Important that this is part of participants' normal recreational routine, and specifically require that attendance is not prompted by participation in this study): Participants to use sound level meter provided from the Audiology Department at Charing Cross Hospital to measure sound levels inside the loud event.
~Morning after exposure: Repeat test battery from session one - Ideally as soon as event is over."
15870328|NCT03878875|Diagnostic Test|Session Three Test Battery|1 week later (recovery): Repeat test battery.
15870329|NCT03878849|Drug|2X-121|Every patient will receive daily oral administrations of 3 x 200 mg 2X-121 hard gelatin capsules in a 28-day cycle.
15870330|NCT03878849|Device|2X-121 DRP®|A DRP is an assay that based on samples from a tumor can predict whether the tumor will respond to a specific drug or not.
15870331|NCT03878836|Other|Routine assessments|Routine assessments, no specific intervention
15870333|NCT03878810|Behavioral|Exergaming|A video game-based physical activity training applied using a commercial game console.
15870334|NCT03878784|Drug|Imigran|All patients will undergo this intervention on one of two study days
15870335|NCT03878784|Other|Isotonic Saline|All patients will undergo this intervention on one of two study days
15870336|NCT03878771|Biological|Platelet rich fibrin gel in Orabase|applied on oral mucositis and /or ulcer 3 times per day
15870337|NCT03878771|Drug|Dermovate cream in Orabase|applied on oral mucositis and /or ulcer 3 times per day
15870338|NCT03878758|Device|BD Nano™ PRO|Insulin Pen needle
15870339|NCT03878758|Device|33G Artsana Insupen Extr3me|Insulin Pen Needle
15870340|NCT03878758|Device|34G Artsana Insupen Extr3me|Insulin Pen Needle
15870341|NCT03878758|Device|Simple Diagnostics Comfort EZ™|Insulin Pen Needle
15870342|NCT03878745|Device|Terumo Nanopass® 34G pen needle|Insulin pen needle
15870343|NCT03878745|Device|BD Nano™ PRO 32G pen needle|Insulin pen needle
15870344|NCT03878732|Diagnostic Test|Bindex measurement|One time bone density measurement with ultrasound device
15870345|NCT03878719|Drug|binimetinib|taken orally
15870346|NCT03878719|Drug|encorafenib|taken orally
15870347|NCT03878693|Drug|Fomepizole|IV 4-MP.
15870348|NCT03878693|Drug|APAP|Oral APAP
15870349|NCT03878680|Other|Study questionnaires|"Completion of the International study of Asthma and Allergies in Children(ISAAC)core questionnaires:
~Core questionnaire on wheezing.
~Core questionnaire on rhinitis.
~Core questionnaire on atopic dermatitis."
15870350|NCT03878667|Dietary Supplement|Curves Calcium|Curves Essential Bio-Available Calcium (providing 800 mg/d of calcium [as calcium citrate malate and calcium citrate], 400 IU/d of Vitamin D, 300 mg/d of magnesium, 4 mg/d of zinc, 2 mg/d of copper, 2 mg/d of manganese, 198 mg/d of potassium, 100 mg/d of trace mineral complex, and 2 mg/d of boron).
15870351|NCT03878667|Dietary Supplement|Calcium Carbonate|Calcium (providing 950 mg/d as carbonate)
15870352|NCT03878667|Dietary Supplement|Placebo|Dextrose placebo
15870353|NCT03878654|Drug|Tauroursodeoxycholic Acid|Naturally occurirng bile acid
15870354|NCT03878641|Behavioral|Children in Grade 1 to 5 with literacy and language needs|The investigators deliver a telepractice-based intervention targeting: (a) Word reading and phonics instruction, (b) applying a comprehension monitoring strategy to improve text reading accuracy, and (c) complex sentences use in written text. Participants receive 3 online 50-minute tutoring session weekly across 15 weeks.
15870355|NCT03878628|Drug|Adipose tissue-derived mesenchymal stem cells|CSCC_ASC(22), a ready-to-use suspension containing 22 million adipose tissue-derived mesenchymal stem cells per millilitre
15870356|NCT03878615|Procedure|elective surgery, according to deprtement routine|none, descriptive study
15870357|NCT03878602|Procedure|Delayed umbilical cord clamping|Umbilical cord will be clamped after 1 min after the birth of the newborn
15870358|NCT03878602|Procedure|Immediate umbilical cord clamping|Umbilical cord will be clamped immediately after the birth of the newborn
15870359|NCT03878589|Drug|Oxytocin (OT)|During the 4 week intervention, participants will self-administer twice daily 24 IUs intranasal oxytocin (OT) and will be contacted once a week for assessment of adverse effects and for download of the smartwatch data. During the last week of the intervention period, three assessment sessions will follow that will be identical to the baseline sessions.
15870360|NCT03878589|Drug|Placebo (P)|During the 4 week intervention, participants will self-administer twice daily 24 IUs intranasal placebo (P) and will be contacted once a week for assessment of adverse effects and for download of the smartwatch data. During the last week of the intervention period, three assessment sessions will follow that will be identical to the baseline sessions.
15870361|NCT03878576|Other|REFERENCE: white bread - BGL0 [RP]|Determination of glycemic response after consumption of BGL0.
15870362|NCT03878576|Other|TEST: b-glucan enriched bread - BGL2 [IP1]|Determination of glycemic response after consumption of BGL0.
15870363|NCT03878576|Other|TEST: b-glucan enriched bread - BGL3 [IP2]|Determination of glycemic response after consumption of BGL0.
15870364|NCT03878576|Other|TEST: b-glucan enriched bread - BGL4 [IP3]|Determination of glycemic response after consumption of BGL0.
15870501|NCT03877926|Biological|BioThrax|BioThrax (Anthrax Vaccine Adsorbed; AVA), is currently licensed for post-exposure prophylaxis and pre-exposure prophylaxis of anthrax disease in persons at high risk of exposure.
15870365|NCT03878563|Device|Cellvisio 100 Series (fibered confocal microscopic system)|"This system is intended to allow confocal laser imaging of the internal microstructure of tissues within or adjacent to anatomical tracts, i.e. Gastrointestinal accessed trough an endoscope.
~An 488-nm wavelength laser system is used, images are steamed at a frame rate of 12 frames per second, obtaining real time videos of the mucosa. In this trial we will use the Confocal miniprobe ColoFlex UHD and GastroFlex UHD."
15870366|NCT03878524|Drug|Abemaciclib|Given PO
15870367|NCT03878524|Drug|Abiraterone|Given PO
15870368|NCT03878524|Drug|Afatinib|Given PO
15870369|NCT03878524|Biological|Bevacizumab|Given IV
15870370|NCT03878524|Drug|Bicalutamide|Given PO
15870371|NCT03878524|Procedure|Biospecimen Collection|Undergo collection of biospecimens (including tissue, blood, or previously collected archival specimens)
15870372|NCT03878524|Drug|Bortezomib|Given IV
15870373|NCT03878524|Drug|Cabazitaxel|Given IV
15870374|NCT03878524|Drug|Cabozantinib|Given PO
15870375|NCT03878524|Drug|Capecitabine|Given PO
15870376|NCT03878524|Drug|Carboplatin|Given IV
15870377|NCT03878524|Drug|Celecoxib|Given PO
15870378|NCT03878524|Drug|Cobimetinib|Given PO
15870379|NCT03878524|Drug|Copanlisib|Given IV
15870380|NCT03878524|Drug|Dabrafenib|Given PO
15870381|NCT03878524|Drug|Dacomitinib|Given PO
15870382|NCT03878524|Drug|Darolutamide|Given PO
15870383|NCT03878524|Drug|Dasatinib|Given PO
15870384|NCT03878524|Drug|Doxorubicin|Given IV
15870385|NCT03878524|Biological|Durvalumab|Given IV
15870386|NCT03878524|Drug|Enasidenib|Given PO
15870387|NCT03878524|Drug|Entrectinib|Given PO
15870388|NCT03878524|Drug|Enzalutamide|Given PO
15870389|NCT03878524|Drug|Erlotinib|Given PO
15870390|NCT03878524|Drug|Everolimus|Given PO
15870391|NCT03878524|Drug|Fluorouracil|Given IV
15870392|NCT03878524|Drug|Idelalisib|Given PO
15870393|NCT03878524|Drug|Imatinib|Given PO
15870394|NCT03878524|Biological|Ipilimumab|Given IV
15870395|NCT03878524|Drug|Lenvatinib|Given PO
15870396|NCT03878524|Drug|Leucovorin|Given IV
15870397|NCT03878524|Drug|Lorlatinib|Given PO
15870398|NCT03878524|Drug|Losartan|Given PO
15870399|NCT03878524|Drug|Nab-paclitaxel|Given IV
15870400|NCT03878524|Drug|Neratinib|Given PO
15870401|NCT03878524|Biological|Nivolumab|Given IV
15870402|NCT03878524|Drug|Olaparib|Given PO
15870403|NCT03878524|Drug|Oxaliplatin|Given IV
15870404|NCT03878524|Drug|Palbociclib|Given PO
15870405|NCT03878524|Drug|Panobinostat|Given PO
15870406|NCT03878524|Biological|Pembrolizumab|Given IV
15870407|NCT03878524|Biological|Pertuzumab|Given IV
15870408|NCT03878524|Drug|Ponatinib|Given PO
15870409|NCT03878524|Other|Quality-of-Life Assessment|Ancillary studies
15870410|NCT03878524|Drug|Regorafenib|Given PO
15870411|NCT03878524|Drug|Ruxolitinib|Given PO
15870412|NCT03878524|Drug|Sirolimus|Given PO
15870413|NCT03878524|Drug|Sorafenib|Given PO
15870414|NCT03878524|Drug|Sunitinib|Given PO
15870415|NCT03878524|Drug|Trametinib|Given PO
15870416|NCT03878524|Biological|Trastuzumab Emtansine|Given IV
15870417|NCT03878524|Drug|Tretinoin|Given PO
15870418|NCT03878524|Drug|Vemurafenib|Given PO
15870419|NCT03878524|Drug|Venetoclax|Given PO
15870420|NCT03878524|Drug|Vismodegib|Given PO
15870421|NCT03878524|Drug|Vorinostat|Given PO
15870422|NCT03878511|Dietary Supplement|Lactose|Lactose monohydrate 810 mg, silicon dioxide 20 mg, and magnesium stearate 14 mg
15870423|NCT03878511|Dietary Supplement|Placebo|Dextran 40 EP 671 mg, silicon dioxide 20 mg and magnesium stearate 14 mg
15870424|NCT03878498|Other|therapeutic management|therapeutic management of anal fistula in Crohn Disease
15870425|NCT03878485|Device|MRIdian Linac System from ViewRay|"0.35T MRI combined with a linear accelerator
~This device will be used for the Stereotactic MRI-guided Adaptive Radiotherapy"
15870426|NCT03878485|Radiation|Stereotactic MRI-guided Adaptive Radiotherapy|-The MR-linac will be delivering the radiation
15870427|NCT03878472|Drug|SHR1210|In 28 ± 3 and 14 ± 3 days before surgery, every patients will received SHR-1210 (200mg iv q2w).
15870428|NCT03878472|Drug|apatinib|In 28 ± 3 and 14 ± 3 days before surgery, every patients will received apatinib (250mg orally every day until 10 ± 2 days before surgery).
15870429|NCT03878472|Drug|S1|In 28 ± 3 and 14 ± 3 days before surgery, every patients will received S1 (30mg/m2, bid, po, d1-d9).
15870430|NCT03878472|Drug|Oxaliplatin|In 28 ± 3 and 14 ± 3 days before surgery, every patients will received Oxaliplatin (130mg/m2, ivdrip, d1).
15870431|NCT03878459|Drug|Pioglitazone 45 mg|patients will be started on 15 mg and the dose escalated to the maximal tolerated dose
15870432|NCT03878459|Drug|Placebo|PATIENTS WILL RECEIVE PLACEBO
15870433|NCT03878446|Drug|somapacitan|Somapacitan injected under the skin once a week for a total of 52 weeks
15870434|NCT03878446|Drug|Norditropin®|Norditropin® injected under the skin once a day for a total of 52 weeks
15870435|NCT03878433|Drug|Glisodin|500 mg/day between 12 weeks
15870436|NCT03878433|Other|placebo|Placebo group (20 patients) will receive 2 pills of placebo per day + sunscreen for 6 months
15870437|NCT03878420|Device|Valeda PBM treatment|The Valeda Light Delivery System delivers 590, 660 and 850 nm wavelengths of light to the study eye. The Valeda Light Delivery System will treat through the open eyelid with the 590 nm and 850 nm wavelengths together. The 660 nm wavelength will be treated through the closed eyelid.
15870438|NCT03878420|Device|Valeda Sham treatment|The sham mode emits an approximate 100x reduction in the highest dose for the 660 nm wavelengths as compared to the treatment mode, producing a slightly duller light. The 850 nm (NIR) wavelength (which is not visible light) is not provided in the sham treatment.
15870439|NCT03878407|Other|Monitoring of ARCH variants|Blood samples will be tested for mutations, before patients are given Standard of Care chemotherapy/radiation or after given Standard of Care chemotherapy/radiation. Another testing is done after 3 months and after 1 year if positive for ARCH.
15870440|NCT03878394|Other|aerobic exercise and balance exercises|The first group will be prescribed aerobic exercise and balance exercises as home exercise. Participants in this group will perform 30 min moderate walking exercises and balance exercises. Balance exercises shall consist of feet static stops for 30 second , one leg stance for 30 second, standing at tandem position for 30 second and uplift exercises at the fingertips for 30 second. Exercises will be held once a day for 3 days per week over 6 weeks.Exercise will be held once a day for 3 days per week over six weeks. Participants will be called by the researcher on the days of the exercise and the participant's compliance with the exercise program will be checked.
15870441|NCT03878394|Other|aerobic exercise and balance exercises with cognitive exercises|The second group will be prescribed cognitive tasks combined with aerobic exercise and balance exercises as home exercises. Participants in this group will have 30 minutes of moderate intensity exercise and cognitive tasks combined with balance exercises. Participants will be asked to count backwards from 20 during the walk and then count back the days of the week back and repeat it for 30 minutes. Balance exercises shall consist of feet static stops for 30 second , one leg stance for 30 second, standing at tandem position for 30 second and uplift exercises at the fingertips for 30 second. Patients will be asked to count backwards from 20 to count the days of the week backwards during balance exercises. Exercises will be held once a day for 3 days per week over six weeks. Participants will be called by the researcher on the days of the exercise and the participant's compliance with the exercise program will be checked.
15870442|NCT03878381|Combination Product|Skin Care Cream|The skin care regimen we will be testing includes ingredients such Hyaluronic acid 1%, Vitamin E Acetate, Vitamin A Acetate, Co-enzyme Q 10, L-Arginine, L-glutamine, Phytonadione, Argireline Peptide solution, GABA, Vitamin C, glycolic acid, and Fenugreek.
15870443|NCT03878381|Drug|Placebo|The placebo will be a formula with no active ingredients
15870444|NCT03878368|Dietary Supplement|Sulforaphane|Intervention soup with dietary sulforaphane
15870445|NCT03878368|Dietary Supplement|Placebo|Control soup without dietary sulforaphane
15870446|NCT03878355|Procedure|radical endoscopic sinus surgery (RESS) plus Draf 3 surgery.|"The procedure of RESS was completed as described in full-house FESS (FHF) approach, involving complete removal of all nasal polyps along with a full maxillary antrostomy, total ethmoidectomy, wide sphenoidotomy, and a Draf 2A frontal sinusotomy. Moreover the bilateral inferior two-thirds of MTs were meanwhile resected. The technique for the Draf 3 frontal drillout procedure was described in detail in previous publications with resection of the superior nasal septum, central frontal sinus floor, and frontal beak region, resulting in a widely patent, oval-shaped, common frontal sinus neo-ostium"
15870447|NCT03878355|Procedure|radical endoscopic sinus surgery (RESS)|"The procedure of RESS was completed as described in full-house FESS (FHF) approach, involving complete removal of all nasal polyps along with a full maxillary antrostomy, total ethmoidectomy, wide sphenoidotomy, and a Draf 2A frontal sinusotomy. Moreover the bilateral inferior two-thirds of MTs were meanwhile resected"
15870448|NCT03878355|Procedure|functional endoscopic sinus surgery (FESS)|FESS was performed by Messerklinger technique with middle turbinate preservation
15870449|NCT03878342|Radiation|Radiotherapy|two fractionation regimens will be allowed for whole-breast irradiation: 50 Gy in 25 fractions over 5 weeks or 40 Gy in 15 fractions over 3 weeks. The delivery of an additional dose to the tumour bed (boost) will be at the referring physician discretion, according to the guidelines
15870450|NCT03878342|Other|No Radiotherapy|No Irradiation- Active surveillance
15870451|NCT03878329|Behavioral|remote home monitoring|Will use telemedicine to guide behavior changes in outcomes
15870453|NCT03878303|Drug|AC0058TA|25 mg capsules
15870454|NCT03878303|Drug|Placebo AC0058TA|equivalent dose of investigational product
15870455|NCT03878290|Behavioral|Resilience, Stress, and Ethnicity (RiSE)|Group based stress reduction program focused on helping minorities develop coping and empowerment skills
15870456|NCT03878277|Drug|Starbucks® Cold brew - 325ml bottle|Starbucks® Cold brew 325ml bottles daily [205mg caffeine] will be provided to the participants. Participants will be instructed to drink 1 bottle every morning between 6 and 9 am for 6 days prior to the post-intervention visit. The 7th day is the post-intervention visit, and participants will be asked to drink 1 bottle the morning of the study visit
15870457|NCT03878264|Drug|CORT118335 Oral|CORT118335 900 mg spray-dried dispersion in bottle and vehicle for oral administration
15870458|NCT03878264|Drug|14C-CORT118335 intravenous|14C-CORT118335 solution for infusion 100 µg containing not more than 37 kiloBequerel (1 µCi) 14C
15870459|NCT03878264|Drug|14C-CORT118335 oral|14C-CORT118335 oral solution 150 mg containing not more than 3.3 megaBequerel (90 µCi) 14C
15870460|NCT03878251|Device|Quantitative attention evaluation criteria in intellectual disability|Quantitative interactive attention evaluation tests by using games on touchscreen and or eye tracking (oculometer)
15870461|NCT03878238|Dietary Supplement|Probiotic Bths-003|Probiotic with maltodextrin as a carrier.
15870462|NCT03878238|Other|Placebo|Placebo with maltodextrin base.
15870463|NCT03878225|Dietary Supplement|H.V.M.N. Ketone Ester|The ketone mono ester will be ingested 5 times daily for 3 days (72 hours). Please see above for details.
15870464|NCT03878225|Other|Placebo|The placebo will be ingested 5 times daily for 3 days (72 hours). Please see above for details.
15870465|NCT03878212|Other|mHealth application with interactivity|a mHealth device with interactivity with nurse case manager
15870466|NCT03878212|Other|mHealth application|a mHealth device
15870467|NCT03878199|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic SCT
15870468|NCT03878199|Drug|Liposome-encapsulated Daunorubicin-Cytarabine|Given IV
15870469|NCT03878199|Drug|Ruxolitinib|Given PO
15870470|NCT03878186|Other|Usual Care (UC)|Usual Care: single in-person psycho-educative session with information about HIV, transmission, natural history of the disease, importance of antiretroviral adherence. All the information is based on guidelines and information sheets from InfoVIHt
15870500|NCT03877926|Biological|AV7909|AV7909 consists of Anthrax Vaccine Adsorbed (AVA) drug substance and CPG 7909 adjuvant. AVA drug substance is identical in composition and manufacturing process to commercial BioThrax. BioThrax is currently licensed for post-exposure prophylaxis and pre-exposure prophylaxis of anthrax disease in persons at high risk of exposure. CPG 7909 is an immunostimulatory synthetic oligodeoxynucleotide that functions as an adjuvant. It is designed to induce an enhanced immune response.
15870471|NCT03878186|Behavioral|Cognitive Behavioral Therapy (CBT)|Cognitive behavioral therapy (CBT): Usual Care + Cognitive-behavioral therapy program intervention (AppraHIV). This intervention involves 7 in-person weekly sessions based on Adjuvant Psychological Therapy centered in three areas: cognitive appraisal, affect and adherence and self-care, everyone with different techniques: cognitive techniques, diaphragmatic breathing, scheduling pleasurable activities, use of pillbox, solving problems, planning for the future, etc. The intervention was manualized (according to Template for Intervention Description and Replication TIDieR), piloted and validated.
15870472|NCT03878173|Other|No intervention|No intervention
15870473|NCT03878160|Other|Individual Interview|Individual Interviews will focus on exploring (a) changes after ACS, such as psychosocial changes and health behavior changes; (b) specific preferences for the MBCT intervention; and (c) potential barriers and facilitators of group videoconferencing and (d) blood spot data collection. Individual interviews will use a semi-structured interview guide. Individual interviews will be conducted until thematic saturation is reached. Individual interviews will be audio-recorded for transcription and data analysis.
15870474|NCT03878147|Behavioral|Cognitive Games Training|Brain Powered Games (BPG) uses games for neurocognitive assessment and training, using images and sounds more familiar to African children. As a computerized cognitive rehabilitation training (CCRT) program designed for Sub-Saharan African school-age children, it can help children infected affected directly or indirectly by HIV. BPG consists of 5 core games evaluating different cognitive abilities (learning, memory, language, attention). Each game includes a visual tutorial, several adjustable settings on the administrative side (Admin), and records game play data for research purposes. Village Builder (VB) is a pro-social reasoning/planning world building strategy type game intended to evaluate frontal lobe executive functions in a culture-friendly and enjoyable game manner. It consists of many of the village artistic components as used in BPG but orchestrated into a village setting where children must gather resources and protect them in order to expand the capacity of the village.
15870475|NCT03878134|Device|PHOTON COUNTING CT|Enrolled patients will undergo the requested clinical diagnostic CT study on the PCCT system using the standard detector, with or without IV and/or oral contrast as indicated. They will also undergo a brief PCCT scan as part of the examination. The scan will thus include both clinically indicated radiation exposure with the standard detector and research radiation with the PCCT detector.
15870476|NCT03878121|Biological|Ad4-Env145NFL|10^8 vp doses of Ad4-Env145NFL formulated as a liquid for intranasal administration.
15870477|NCT03878121|Biological|Ad4-Env150KN|10^8 vp doses of Ad4-Env150KN formulated as a liquid for intranasal administration.
15870478|NCT03878121|Biological|VRC-HIVRGP096-00-VP (Trimer 4571) with alum|500-mcg dose of protein boost vaccine formulated for intramuscular administration.
15870479|NCT03878108|Dietary Supplement|LCHF diet|low-carbohydrate, high-fat (LCHF)diet
15870480|NCT03878108|Dietary Supplement|LFHC diet|low-fat, high-carbohydrate (LFHC) diet
15870483|NCT03878082|Drug|Propacetamol 1g|pain control with IVPCA and propacetamol 1g every 6 hours for 2 days
15870484|NCT03878082|Drug|Propacetamol 2g|pain control with IVPCA and propacetamol 2g every 6 hours for 2 days
15870485|NCT03878082|Drug|IVPCA|pain control with IVPCA
15870486|NCT03878069|Biological|elapegademase-lvlr|"Patients transitioning from Adagen: For patients currently receiving Adagen at ≤ 30 U/kg/wk or an unknown Adagen dose, the suggested dosage of Revcovi is 0.2 mg/kg/wk IM. For patients currently receiving Adagen at > 30 U/kg/wk the suggested equivalent Revcovi dosage (mg/kg/wk) is the Adagen dosage in U/kg/wk divided by 150.
~At the investigator's discretion, the total weekly dose may be divided and administered in multiple IM injections, increased by 0.033 mg/kg/wk if trough ADA activity is < 30 mmol/hr/L, dAXP is > 0.02 mmol/L, and/or the immune reconstitution is inadequate.
~Adagen-naïve patients: The suggested starting Revcovi dosage is 0.2 mg/kg twice weekly IM based on ideal body weight, for a minimum of 12 to 24 weeks until immune reconstitution is achieved. At the investigator's discretion, the dosage may be gradually increased to maintain trough ADA activity > 30 mmol/hr/L, dAXP < 0.02 mmol/L, and/or to maintain adequate immune reconstitution."
15870487|NCT03878056|Device|Vaginal: UpholdTM Lite Vaginal Support - Boston Scientific|Apical prolapse reconstructive surgery by Transvaginal mesh vs Robotic sacral colpopexy
15870488|NCT03878043|Other|Follow-up Care|Follow up care provided upon readmission to patients who were diagnosed with a TSDH upon initial visit.
15870489|NCT03878030|Drug|nusinersen|Subjects will receive nusinersen and be observed with motor assessments for 24 months
15870490|NCT03878017|Procedure|skin marking of clip axillary lymph node for localisation|to determine the feasibility of skin marking to localize clipped ln
15870491|NCT03878004|Biological|GamTBvac vaccine|introduction of GamTBvac (lyophilisate for preparation of solution for subcutaneous administration, 5.35 mg / dose) twice into a shoulder with an 8-week interval.
15870492|NCT03878004|Biological|placebo|introduction of placebo twice into a shoulder with an 8-week interval.
15870493|NCT03877991|Drug|CBD-sesame oil capsule|A capsule containing cannabidiol dissolved in sesame oil and surfactant vehicle.
15870494|NCT03877991|Drug|CBD-LNL capsule|A capsule containing Cannabidiol dissolved in self nano emulsifying formulation
15870495|NCT03877991|Drug|CBD powder form capsule|Powder of Cannabidiol filled in a hard gelatin capsule, without formulation.
15870496|NCT03877978|Biological|Nephrocheck test|Nephrocheck® measurement on urine sample at different timepoints.
15870497|NCT03877965|Drug|Digoxin|Drug administered per standard of care, with a dosing regimen within the labeled dose range of 7.5-20 mcg/kg/day divided in 2 or 3 equal doses
15870498|NCT03877952|Drug|14C-CORT125281|14C-CORT125281 360 mg capsule for oral administration containing not more than 2.5 megaBequerel (67 μCi) 14C
15870499|NCT03877939|Diagnostic Test|Blood samples collection for analysis|"Blood samples:
~Blood samples will be collected for the determination of the levels of various biomarkers (Kisspeptins and miRNAs), which are molecules that regulate the expression of proteins and can serve as markers for predicting pregnancy viability. Additionally, after biochemical or week 10 of clinical pregnancy confirmation, blood samples will be collected for KIR and HLA-C typing, Oral glucose tolerance test (OGTT) and analysis of the levels of miRNAs related with insulin resistance, miR-424-5p and miR-15b.
~Uterine biopsy (only in patients with BP):
~Uterine biopsy samples will be collected also after biochemical pregnancy confirmation for the determination of the levels of miRNAs related with insulin resistance, miR-424-5p and miR-15b."
15870502|NCT03877887|Diagnostic Test|echo cardiogram|Assessment of left ventricular systolic and diastolic function
15870503|NCT03877874|Drug|Aironyl syrup(Terbutaline sulfate) + Epidrone syrup(Dexamethone)|Aironyl syrup(Terbutaline sulfate ................. 1.5mg) 0.075-0.29 mg/ kg body weight 3 times daily Apidone syrup(Dexamethone) (0.02 to 0.3 mg per kilogram (kg) of body weight per day, divided and taken 3 or 4 times a day)
15870504|NCT03877861|Device|Readiband Sleep Tracking|Once a patient has consented to study progression, a Readiband™ Sleep Tracker device will be provided to the patient, along with necessary instructions. Patients will return home with the device and fatigue data will be obtained from the device at subsequent standard care follow-up visits. In addition, surveys related to fatigue and quality of life will be administered via secure electronic survey to participants.
15870505|NCT03877848|Device|Percutaneous Coronary Intervention (PCI)|Patients enrolled to the study will undergo angiography followed by PCI according to current guidelines.
15870506|NCT03877835|Procedure|Peripheral nerve blocks|LSIB + SSNB
15870507|NCT03877822|Behavioral|Habitual activity|Two days of habitual physical activity, under normal free-living conditions
15870508|NCT03877822|Behavioral|Bed rest|Two days of bed rest, to induce whole-body physical inactivity
15870509|NCT03877809|Drug|Sirolimus 0.5 mg|Daily administration of 1 or more tablets
15870510|NCT03877796|Device|Drug Response Predictor® (DRP)|A DRP is an assay that based on samples from a tumor can predict whether the tumor will respond to a specific drug or not.
15870511|NCT03877783|Dietary Supplement|mediterranean diet|The recommended Mediterranean diet is based on lean meat, fish, eggs, vegetables, fruits, berries, and nuts. Extra-virgin olive oil is the recommended additional fat source for use in food preparation and dressings. Recommended exclusions or restrictions include dairy products, cereals, added salt, refined fats, and sugar. Participants in the intervention group will receive weekly deliveries of olive oil and mixed nuts, free of cost, and they will receive recipes for Mediterranean meals on a regular basis. During the study, the intervention group will receive written, personalized advice from a project dietician on how to improve their Mediterranean diets. This written personalized advice will be based on the reported food intake, its coherence with a Mediterranean diet, and its adherence to the recommended intakes of energy and nutrients for each participant.
15870512|NCT03877783|Behavioral|individualized fitness program|The exercise intervention will consist of individualized training programs designed to improve cardiovascular fitness (VO2). A personal trainer will distribute the training program instructions and monitor the training during the entire intervention. Support will be provided via text messages. The training intensity will be based on results from an extensive pre-test of individual physical fitness performance, and we will adjust the intensity over the study period, as fitness improves. The goal is to engage participants in training three times per week, for up to one hour per training session. The individualized training programs will consist of brisk walks, jogging, and cycling, tailored to each participant. To ensure that the training intensity is sufficient to improve cardiovascular fitness, heart rate will be monitored during each session.
15870513|NCT03877783|Other|recommended modified pharmacological treatment|"Hyperglycemia: first metformin till target level of HbA1c 1) 53-58 mmol/mol for patients with ≤2 coexisting chronic illnesses or 2) 59-64 mmol/mol for those with established cardiovascular disease (CVD). We will recommend a second glucose-lowering drug when HbA1c is not achieved and which reduce CVD even when the participant does not have a manifest CVD.
~Hypertension: will be treated to achieve a target level according to European guidelines. Start with a combination of a renin-angiotensin system (RAS)-blocker and a thiazide in low dose or a combination of a RAS-blocker a calcium channel blocker in low dose. If the target is not reached within 12 weeks additional drugs should be added.
~Dyslipidemia: Patients with a CVD risk of 2-8% within 5 years should receive treatment with atorvastatin 10mg +ezetimib 10mg; CVD risk 8-20%, atorvastatin 20mg + ezetimib 10mg and CVD risk > 20% atorvastatin 40-80mg +ezetimib 10mg."
15870514|NCT03877744|Behavioral|interactive virtual presence|parents will install car seat through remote guidance via interactive virtual presence
15870515|NCT03877744|Behavioral|live technician|parents will install car seat through guidance from a live certified technician who is present
15870516|NCT03877731|Procedure|isolated septal myectomy|
15870517|NCT03877731|Procedure|septal myectomy + edge-to-edge mitral valve repair|
15870518|NCT03877731|Procedure|septal myectomy + posterior leaflet sliding plasty|
15870519|NCT03877731|Procedure|septal myectomy + secondary chordae transection|
15870520|NCT03877718|Drug|Arm 1: CL-H1T|One capsule of CL-H1T (total dose: sumatriptan succinate 90mg/promethazine HCl 18.75 mg)
15870521|NCT03877718|Drug|Arm 2: CL-H1T|One capsule of CL-H1T (total dose: sumatriptan succinate 90mg/promethazine HCl 37.5 mg)
15870522|NCT03877718|Drug|Arm 3: Sumatriptan Succinate 100 mg capsule|One capsule of sumatriptan succinate 100 mg
15870523|NCT03877718|Drug|Arm 4: Promethazine HCl 18.75 mg|One capsule of promethazine HCl 18.75 mg
15870524|NCT03877718|Drug|Arm 5: Promethazine HCl 37.5 mg|One capsule of promethazine HCl 37.5 mg
15870525|NCT03877718|Other|Placebo|One capsule of placebo
15870526|NCT03877705|Drug|Listerine ready tabs|Technically, it's a rectangular-shaped, bilayer-compressed tablet that once chewed, creates just enough liquid to swish around your mouth to get a whole-mouth clean feeling.As manufacture claimed the tablet is easy to use just in three simple steps: chew (to activate), swish (to clean), then swallow as unlike mouthwashes which may contain alcohol and other ingredients not intended for ingestion, Listerine Ready Tabs are alcohol-free and safe to swallow which is highly suitable for bedridden patients.
15870527|NCT03877692|Drug|Experimental dosing of labetalol|Subjects with preexisting hypertension who have sustained severe hypertension (SBP≥160 mmHg and/or DBP≥110 mmHg), 15 min apart receive the experimental dosing of labetolol. Subjects in both groups are managed following the standard guidelines established by ACOG (Committee Opinion #623). For each successive episode of hypertension treatment, patients are asked a set of questions to monitor for adverse medication side-effects. The fetus is electronically monitored for four hours after the last IV dose.
15870588|NCT03877237|Other|Placebo|Tablets administered orally once daily. Treatment start within 24h after randomisation for 16 weeks.
15870589|NCT03877224|Drug|Dapagliflozin|Tablets administered orally once daily. Treatment start within 24h after randomisation for 16 weeks.
15870590|NCT03877224|Other|Placebo|Tablets administered orally once daily. Treatment start within 24h after randomisation for 16 weeks.
15871919|NCT03866824|Device|RMI|A CONTROL RMI at 1 year follow-up.
15870528|NCT03877692|Other|Standard dosing of labetalol|Subjects with preexisting hypertension who have sustained severe hypertension (SBP≥160 mmHg and/or DBP≥110 mmHg), 15 min apart receive either the standard of care dosing of labetolol. Subjects in both groups are managed following the standard guidelines established by ACOG (Committee Opinion #623). For each successive episode of hypertension treatment, patients are asked a set of questions to monitor for adverse medication side-effects. The fetus is electronically monitored for four hours after the last IV dose.
15870529|NCT03877679|Drug|Triamcinolone|Triamcenolone +napolycarboxylate
15870530|NCT03877679|Drug|Turmeric paste|Topical turmeric paste (a mixture of curcumin powder and vegetable glycerin base in a ratio of 1:8 by weight) Mix with 85ml carbapol gel (125ml H2O + 0.5g carbapol + triethanolamine 3 drops) prepared in the Faculty of pharmacy-Cairo University
15870531|NCT03877653|Device|Wireless neuromodulation|A needle and catheter are carefully inserted near the enervated nerve. The stimulator is then placed through the catheter close to the nerve. The proximal end of the stimulator is then sutured underneath the skin to prevent migration.
15870532|NCT03877640|Device|BTL EMSELLA|High intensity focused electromagnetic (HIFEM) technology induces deep pelvic floor muscle contractions designed to deliver the equivalent of 11,200 Kegel exercises over 28 minutes.
15870533|NCT03877627|Procedure|Pelvic and Peritoneal Lymphadenectomy|Patients in arm 2 will be randomized to undergo pelvic and peritoneal lymphadenectomy to treat their endometrial carcinoma.
15870534|NCT03877614|Other|ASCVD risk score|ASCVD score< 10% will be in the control or low-risk group
15870535|NCT03877601|Drug|Bevacizumab-IRDye800CW|Topical administration of Bevacizumab-IRDye800CW during the endoscopic procedure.
15870536|NCT03877601|Diagnostic Test|Fluorescence endoscopy|Device: Molecular Fluorescence Endoscopy platform A flexible fluorescence fiber-bundle is attached to a fluorescence camera platform to enable the detection of fluorescence signals. The fluorescence fiber-probe is inserted through the standard working channel of the standard clinical endoscope.
15870537|NCT03877588|Dietary Supplement|Oral Nutritional Support|Preoperative oral nutritional support is provided according to malnutrition grade
15870538|NCT03877575|Other|No specific intervention. Collection of clinical data|
15870539|NCT03877562|Drug|Olanzapine|Olanzapine 10 mg oral tablet
15870540|NCT03877562|Drug|CORT118335|CORT118335 600 mg oral tablets administered as 2 X 300 mg or 6 X 100 mg tablets
15870541|NCT03877562|Drug|Placebo|Placebo matching CORT118335, 2 or 6 oral tablets, depending on the CORT118335 tablet strength available
15870542|NCT03877549|Drug|Dexamethasone|Additional of two different doses of dexamethasone via the epidural catheter during surgical closure after cesarean section
15870543|NCT03877536|Drug|Genvoya 150Mg-150Mg-200Mg-10Mg Tablet|Participants will receive 1 tablet per day throughout study duration (96 weeks).
15870544|NCT03877523|Dietary Supplement|Cocarnit|a metabolic complex
15870545|NCT03877510|Drug|IPX203 140 mg|35 mg - 140 mg CD-LD extended release capsules
15870546|NCT03877510|Drug|IPX203 210 mg|52.5 mg - 210 mg CD-LD extended release capsules
15870547|NCT03877510|Drug|IPX203 280 mg|70 mg - 280 mg CD-LD extended release capsules
15870548|NCT03877510|Drug|IPX203 350 mg|87.5 mg - 350 mg CD-LD extended release capsules
15870549|NCT03877497|Behavioral|Adapted SBIRT for transgender women|Transgender women will be screened for substance use. Those at moderate risk or less will be randomized into the study into either the intervention arm (SBIRT-A) or the control arm (CONTROL-C). Those at higher risk will be ineligible for the study and referred for substance use treatment services
15870550|NCT03877484|Device|ALLEVYN Gentle border|ALLEVYN Gentle border is a triple layer foam dressing consisting of a highly absorbent hydrocellular foam pad held between a perforated wound contact layer (WCL), which is coated with a soft silicone gel adhesive and a highly permeable outer top film.
15870551|NCT03877471|Genetic|Cell therapy|Ovary injection with MSC-like cells through transvaginal ultrasound,3 injection points for each ovary.
15870552|NCT03877458|Other|L. acidophilus TYCA06, B. longum BLI-02 and B. bifidum VDD088|Taking 1 mix probiotics capsule at bed time everyday for three months.
15870553|NCT03877458|Other|L. reuteri GL-104|Taking 1 probiotic capsule at bed time everyday for three months.
15870554|NCT03877458|Other|Placebo|Taking 1 placebo capsule at bed time everyday for three months.
15870555|NCT03877445|Device|exposition half-face|Patients will be included in the study and exposed on a half-face from Day1 to Day5. The other half-face will serve as unexposed control. The effect of blue light on the melasma lesions will be assessed from Day 1 to Day 6 using chromametry and a modified Melasma Area and Severity Index on standardized photographs
15870556|NCT03877432|Device|Dermatome stimulation|Dermatome (S2-S4) stimulation is aimed at improving the function of bladder storage and bladder capacity. A total of 8 serial cystometrograms will be performed: 2 control fills, followed by 4 fills with stimulation, followed by 2 control fills. The minimum (or threshold) stimulation amplitude (T) necessary to elicit the genito-anal reflex was first determined for each subject. Subsequently, each subject received a randomized sequence of cystometric fill trials with and without continuous dermatome stimulation. The dermatome stimulation was randomly stimulated at stimulation amplitudes of 1, 2, 3, and 4 T.
15870557|NCT03877406|Drug|Empagliflozin 10 MG|addition of empagliflozin 10 MG
15870558|NCT03877406|Drug|Hypoglycemics Oral|dose escalation of hypoglycemics oral
15870559|NCT03877393|Combination Product|Probiotic supplementation + gluten-free diet|The probiotic and gluten-free diet group (PRO-GFD) will receive one capsule containing the probiotic mixture powder (Sanprobi Stress; Sanprobi sp. z o.o., sp.k., Szczecin, Poland) in the amount of 3 × 10^9 colony forming units (CFU) per day divided in two equal doses, comprising two bacteria strains: Lactobacillus helveticusRosell®-52, Bifidobacterium longumRosell®-175, and excipients: potato starch, magnesium stearate, and the capsule shell of hydroxypropyl methylcellulose. The participants will be asked to consume supplements before breakfast. The group will follow the elimination diet containing no gluten.
15870560|NCT03877393|Combination Product|Placebo supplementation + gluten-free diet|The placebo and gluten-free diet group (PLA-GFD) will receive one capsule containing only the excipients, i.e. maize starch, maltodextrins, and the capsule shell. The participants will be asked to consume supplements before breakfast. The group will follow the elimination diet containing no gluten.
15870626|NCT03876925|Drug|CT053PTSA|Patients will received oral CT053PTSA once daily until disease progression or intolerable toxicity or subject's withdrawal from treatment ,each cycle is defined as 28 days
15870561|NCT03877393|Combination Product|Probiotic supplementation + gluten-containing diet|The probiotic and gluten-containing diet group (PRO-GD) will receive one capsule containing the probiotic mixture powder (Sanprobi Stress; Sanprobi sp. z o.o., sp.k., Szczecin, Poland) in the amount of 3 × 10^9 colony forming units (CFU) per day divided in two equal doses comprising two bacteria strains: Lactobacillus helveticusRosell®-52, Bifidobacterium longumRosell®-175 and excipients: potato starch, magnesium stearate, and the capsule shell of hydroxypropyl methylcellulose. The participants will be asked to consume supplements before breakfast. The group will stay with their current diet.
15870562|NCT03877393|Combination Product|Placebo supplementation + gluten-containing diet|The placebo and gluten-containing diet group (PLA-GD) will receive one capsule containing only the excipients, i.e. maize starch, maltodextrins, and the capsule shell. The participants will be asked to consume supplements before breakfast. The group will stay with their current diet.
15870563|NCT03877380|Other|semi-structured interview|Semi-strucured interview to identify the difficulties when first applying for a personalised autonomy allowance by beneficiaries and their relatives
15870564|NCT03877367|Other|Upper extremity manipulation|An upper extremity (glenohumeral, humeroulnar and radioulnar joints, bilaterally) or a lower extremity (coxofemoral, tibiofemoral, and tibiotalar, bilaterally) manipulation series.
15870565|NCT03877354|Other|Data from anaesthesia records for ventilation setting screening|Data from anaesthesia records will be retrospectively screened for the ventilation settings
15870566|NCT03877354|Other|Data from intensive care records for ventilation setting screening|Data from paediatric intensive care charts will be retrospectively screened for the ventilation settings
15870567|NCT03877341|Device|X-RAY|x-ray on lumbosacral antro-posterior and lateral and dynamic veiws CT lumbosacral +mri lumbosacral
15870568|NCT03877328|Other|BiotechCoachForAll|A group of thirty subjects diagnosed with heart failure (HF) of any etiology undergo an experimental procedure in the following order: resting-state (eyes-closed), passively viewing thirty two agents which are grouped with respect to different appearance characteristics and passively viewing combinations of virtual agents. During the experiment, brain activity, heart rate, skin conductance, temperature and eye-gaze biosignals are collected by means of electroencephalography, Empatica E4 and Gazepoint. Subsequently, a prospective cohort study is performed in a subgroup of ten participants which undergo a three additive stage procedure. Stage 1, a wearable monitoring device (Wavelet Health) is given in order to provide objective information on the patient's activity. Stage 2, the FitForAll physical exercise program is introduced. Stage 3, introduces the coaching aspects, where personalized recommendations and suggestions are delivered through home surfaces' projection.
15870569|NCT03877315|Device|Stemmed shoulder arthroplasty, Biomet Comprehensive® Total Shoulder System.|A total shoulder prosthesis used in treating glenohumeral osteoarthritis
15870570|NCT03877315|Device|Stemless shoulder arthroplasty, Biomet Comprehensive® Nano Shoulder System.|A total shoulder prosthesis used in treating glenohumeral osteoarthritis
15870571|NCT03877302|Other|reflexology|foot reflexology
15870572|NCT03877289|Drug|Oxybutynin|Oxybutynin is a tertiary amine anticholinergic. It exerts both antispasmodic and antimuscarinic activity on smooth muscle. It also exerts analgesic and local anaesthetic effects.
15870573|NCT03877289|Other|"Orasweet Liquid Placebo"|A formulated Oxybutynin placebo that is nearly identical in appearance, volume, weight, taste, and smell.
15870574|NCT03877289|Drug|Antibiotics|"All patients in treatment and control arms were treated as a co-intervention with an oral antibioitic, the type of which was chosen by the child's attending physician.
~Possible prescribed antibiotics include: trimethoprim and sulfamethoxazole (Septra), Cefalotin, Cephalexin, Cefapirin, Cefdroxil, Cefazolin, Cefradine, Cefacetrile, Cefaloridine, Cefroxadine, Cefatrizine, Cefuroxime, Cefixime, amoxicillin/clavulanic acid (Clavulin), and Nitrofurantoin."
15870575|NCT03877276|Dietary Supplement|Breakfast|a prepared meal consisting of pastry and 2 cooked egg whites
15870576|NCT03877276|Dietary Supplement|Spinach smoothie|a prepared blended spinach smoothie, consisting of banana, avocado, orange juice, and spinach
15870577|NCT03877276|Dietary Supplement|Kale smoothie|prepared blended kale smoothie, consisting of banana, avocado, orange juice, and kale
15870578|NCT03877276|Dietary Supplement|Blended smoothie|a prepared blended smoothie, consisting of banana, avocado, and orange juice
15870579|NCT03877276|Dietary Supplement|V spinach smoothie|a prepared blended spinach smoothie, consisting of banana, avocado, orange juice, and a varying amount (low, medium, high) of spinach
15870580|NCT03877276|Dietary Supplement|Sodium oxalate drink|a prepared sodium oxalate drink
15870581|NCT03877263|Diagnostic Test|Endocervical swab for detection of STI|After we collect the samples, they will be evaluated using the Hologic APTIMA Chlamydia trachomatis and Neisseria gonorrhoeae assays.
15870582|NCT03877263|Diagnostic Test|Vaginal swab for detection of STI|"After we collect the samples, they will be evaluated using the Hologic APTIMA Chlamydia trachomatis and Neisseria gonorrhoeae assays.
~We will then compare the results from a vaginal vs. endocervical specimens within and between the groups"
15870583|NCT03877250|Diagnostic Test|Pre-Treatment Biopsy|Participants screened for participation will include those with a diagnosis of advanced NSCLC who have undergone a pre-treatment biopsy prior to start of therapy with a PD-(L)1 inhibitor or who are medically able to undergo a biopsy if (1) no pre-treatment biopsy has been obtained and (2) no PD-(L)1 inhibitor has been started.
15870584|NCT03877250|Diagnostic Test|On-Treatment Biopsy|All participants who receive at least 1 dose of PD-(L)1 inhibitor will be referred for a biopsy. The biopsy should be obtained within 4 weeks of first on-treatment imaging (usually performed ~6-9 weeks after beginning therapy) and will be performed in participants regardless of radiologic response.
15870585|NCT03877250|Diagnostic Test|Biopsy at Disease Progression|All participants who develop disease progression after initial response to PD-(L)1 blockade will be considered for an additional, optional biopsy. Biopsies at disease progression are often obtained per standard of care within 4 weeks of documented progression on imaging and prior to the initiation of further systemic therapy.
15870586|NCT03877250|Diagnostic Test|Peripheral Blood-Based Studies|All participants will have peripheral blood obtained on Day 1 of cycles 1-4 (0, 3, 6, and 9 weeks). At each time point, peripheral blood sample will be collected pre-treatment and used for analysis of T cell subsets and TCR sequencing.
15870587|NCT03877237|Drug|Dapagliflozin|Tablets administered orally once daily. Treatment start within 24h after randomisation for 16 weeks.
15870748|NCT03875859|Drug|Remetinostat|Topical 1% remetinostat gel
15870591|NCT03877211|Other|speech audiometry in noise|Subjects will be asked to repeat lists of words played by speakers in a noisy environment generated by the same speakers. A percentage of correct recognition is calculated for each list.
15870592|NCT03877211|Other|Psychophysical tuning curves in forward masking|Sounds of variable center frequency are used as maskers, and a tone with a fixed frequency at a fixed level is the target. What is tested here is the level of masker that just masks the target.
15870593|NCT03877211|Other|Electrically-evoked Auditory Brainstem Response (EABR)|Channel interaction assessment using eABRs (auditory nerve responses). The method consists of two measurements: 1) eABR measurements with stimulation by a single electrode of the cochlear implant at 70% of the dynamic range (four different electrodes are tested); 2) Measurement of a single eABR with stimulation from all four electrodes at 70% of the dynamic range. A comparison of the eABRs obtained by these two measurements, indicates the electrical and neural interactions between the electrodes.
15870594|NCT03877211|Other|Tonal audiometry|Tonal audiometry will be performed with headphones
15870595|NCT03877211|Other|Auditory canal examination|Otoscopic examination of external auditory canal and eardrum
15870596|NCT03877198|Device|Automated oxygen control by the CLiO2 algorithm|Automated oxygen control for 24 hours by the CLiO2 algorithm, preceded by a 1 hour wash-out period
15870597|NCT03877198|Device|Automated oxygen control by the Oxygenie algorithm|Automated oxygen control for 24 hours by the Oxygenie algorithm, in case of switch in ventilator preceded by a 1-hour wash-out period.
15870598|NCT03877185|Diagnostic Test|Live birth rate|Live Birth Rate and Blastulation Rate according to the protocol of COS
15870599|NCT03877172|Device|High-flow nasal cannula|To provide high-flow nasal cannula in the immediate postoperative period after lung resection surgery as compared to conventional face-mask therapy, in a randomized sequence, for 30 minutes.
15870600|NCT03877159|Other|There is no intervention.|There is no intervention. This is a retrospective study analysing archived tumour samples.
15870601|NCT03877146|Behavioral|Controlled Breathing Intervention|Participants in the controlled breathing intervention will be provided with headphones to listen to the guided intervention audio file. The intervention will guide participants to breathe at a rate of six breaths per minute (approximately 50% of their normal breathing rate).
15870603|NCT03877120|Drug|Dexmedetomidine 0.004 MG/ML|Experimental studies and single case reports suggest the α2-agonist dexmedetomidine is effective in managing the autonomic symptoms seen with alcohol withdrawal.
15870604|NCT03877120|Drug|Diazepam Injectable Solution|diazepam start with 5-20 mg IV as a dose response, steps until a maximum dose of 120 mg diazepam.
15870605|NCT03877107|Diagnostic Test|Urinary symptoms profile questionnaire|Validated questionnaire (international) with validated french translation, before and after lumbar puncture, and after surgery if surgery is realized
15870606|NCT03877107|Diagnostic Test|Micturition calendar|Micturition calendar on 2 consecutive days, before and after lumbar puncture, and after surgery if surgery is realized
15870607|NCT03877094|Behavioral|Nature virtual reality video|the patient will receive a head-set dispositive to watch a nature virtual reality video during the whole procedure of breast biopsy
15870608|NCT03877081|Biological|Probiotics|Administration of oral probiotics with 2 doses a day
15870609|NCT03877081|Other|Placebo|Administration of oral placebo with 2 doses a day
15870610|NCT03877068|Device|Dexcom G6 CGM - Continues Glucose Monitoring sensor system|A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay up to 10 days using the Dexcom Studio software to download the Dexcom receiver data.
15870611|NCT03877068|Diagnostic Test|POC BG - Point-of-Care Blood Glucose monitoring|Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay up to 10 days.
15870612|NCT03877055|Drug|Copanlisib|Treatment will be with intravenous copanlisib on days 1, 8, 15 of 28 day cycles.
15870613|NCT03877055|Drug|Ibrutinib|Oral ibrutinib daily in 28 day cycles. A cycle is defined as 28 days of therapy.
15870614|NCT03877042|Device|Cruciate-retaining (CR) prostheses|One leg is conducted TKA with Cruciate-retaining (CR) prostheses.
15870615|NCT03877042|Device|Posterior-stabilized (PS) prostheses|One leg is conducted TKA with Posterior-stabilized (PS) prostheses.
15870616|NCT03877016|Procedure|TENS|TENS Eco2 or actiTENS, both admitted and reimbursed in FRANCE according to regulation
15870617|NCT03877003|Other|Eggs|Eggs: Consume 3 eggs per day for 4 weeks Choline supplement: Consume 1.5 pills per day for 4 weeks
15870618|NCT03876990|Diagnostic Test|Multiplex PCR|Quick adaptation of antibiotic treatment according to the species identified and to the results of the resistance markers present in the multiplex PCR
15870619|NCT03876990|Diagnostic Test|Current strategy alone|Identification of bacteria and micromyces isolated in blood cultures after subculture by mass spectrometry (MALDI-TOF) and determination of their sensitivity to antibiotics or antifungals by antibiotic susceptibility testing or antifungigram
15870621|NCT03876964|Device|Transcatheter Aortic Valve Replacement|Minimally invasive replacement of the aortic valve through a catheter.
15870622|NCT03876951|Diagnostic Test|Vacuum-assisted biopsy|Patients will be submitted to percutaneous vacuum-assisted biopsy (VAB), followed by breast surgery.
15870623|NCT03876938|Drug|aprepitant|aprepitant 125 mg orally, dexamethasone 12 mg iv, ondansetron 8 mg iv before chemotherapy aprepitant 80 mg orally D2-4, dexamethasone 8 mg/day orally D2-4
15870624|NCT03876938|Drug|olanzapine 10 mg|olanzapine 10 mg orally, dexamethasone 12 mg iv, ondansetron 8 mg iv before chemotherapy olanzapine 10 mg orally D2-4, dexamethasone 8 mg/day orally D2-4
15870625|NCT03876938|Drug|olanzapine 5 mg|olanzapine 5 mg orally, dexamethasone 12 mg iv, ondansetron 8 mg iv before chemotherapy olanzapine 5 mg orally D2-4, dexamethasone 8 mg/day orally D2-4
15884472|NCT03770299|Drug|Carboplatin|Specified dose on specified days
15870627|NCT03876912|Drug|GnRH antagonist|18F-PSMA 1007 PET/CT before, 3 weeks after ADT, at 1 year and at CRPC in 35 patients. 18F-FDG PET/CT in a subgroup of 20 patients before ADT.
15870628|NCT03876899|Dietary Supplement|Evening Primrose Oil|botanical oil derivative from the seeds of Evening Primrose (Oenothera biennis),1,300 milligrams t.i.d.
15870629|NCT03876899|Dietary Supplement|Placebo|Pill
15870630|NCT03876886|Drug|Epirubicin|Epirubicin 90mg/m2 iv d1 or divide into two days
15870631|NCT03876886|Drug|Cyclophosphamide|cyclophosphamide600mg/m2 iv d1,q14d*4cycles;with G-CSF support: 3ug/kg ih
15870632|NCT03876886|Drug|Paclitaxel|paclitaxel 175mg/m2 iv d1, q14d*4cycles
15870633|NCT03876886|Drug|Carboplatin|carboplatin AUC=3 iv d2, q14d*8cycles;with G-CSF support: 3ug/kg ih
15870634|NCT03876886|Drug|Paclitaxel|paclitaxel 175mg/m2 iv d1, q14d*8cycles
15870635|NCT03876873|Procedure|Head Rotation During Face Mask Ventilation|Participants will receive face mask ventilation in either a neutral head position (practice standard position) or a head rotation position (45 degree angle).
15870636|NCT03876873|Device|Medline Top Valve Anesthesia Mask|Face mask used per standard of care to provide oxygen to subjects before surgical procedures.
15870637|NCT03876860|Device|Silicone Dilator|Addition of silicone band to standard vaginal dilator
15870638|NCT03876860|Device|Standard Dilator|Standard vaginal dilator
15870639|NCT03876834|Other|respiratory training|Respiratory training was done by using threshold inspiratory muscle trainer(Respironics, New Jersey , USA, No.8373-0730)
15870640|NCT03876808|Device|Bair Hugger™ Temperature Management Unit Model 750|Forced-air temperature management unit used for preoperative and intraoperative participant warming
15870641|NCT03876808|Device|3M™ Bair Paws™ Flex Gown|Bair Paws™ patient warming gown used for preoperative and intraoperative participant warming
15870642|NCT03876795|Biological|Bone Marrow Concentrate|Bone Marrow Concentrate injection
15870643|NCT03876782|Diagnostic Test|IOLMaster|IOL power calculation will be done with IOLMaster
15870644|NCT03876782|Diagnostic Test|Verion|IOL power calculation will be done with Verion
15870645|NCT03876769|Biological|CTL019|"Based on the subject's weight, one of two possible dose ranges will be prepared for the subject:
~Subjects ≤ 50 kg: 0.2 to 5.0 x 10(6) CAR-positive viable T cells per kg body weight
~OR
~Subjects > 50 kg: 0.1 to 2.5 x 10(8) CAR-positive viable T cells"
15870646|NCT03876756|Other|postpartum acute urinary retention|Collection of risk factors
15870647|NCT03876756|Other|no postpartum acute urinary retention|Collection of risk factors
15870648|NCT03876743|Other|Group 1-Knee Arthroscopy|Will have all of their post-operative prescriptions sent down to the pharmacy on the day of surgery to be collected.
15870649|NCT03876743|Other|Group 2-Knee Arthroscopy|Will have all prescriptions sent to pharmacy with the exception of an opiate prescription. Instead, they will be handed a physical paper prescription. They will be instructed to only fill the prescription if absolutely needed.
15870650|NCT03876743|Other|Group 1-ACL reconstruction|Will be prescribed 60 opiate tablets in addition to other routine post-operative pain medication regimens.
15870651|NCT03876743|Other|Group 2-ACL reconstruction|Will be prescribed 30 opiate tablets in addition to other routine post-operative pain medication regimens.
15870652|NCT03876730|Other|ICF CP Core Set|Core set
15870653|NCT03876717|Drug|Colesevelam Hydrochloride|Colesevelam is a sequestrant that binds bile acids in the intestinal lumen, the bile acids are then excreted with the feces. Colesevelam is registered for treating hypercholesterolemia but it is as other sequestrants (e.g. cholestyramine and colestipol) effective against bile acid diarrhoea.
15870654|NCT03876717|Drug|Placebo oral capsule|Inactive placebo tablets over-encapsulated with DB caps AAA
15870655|NCT03876704|Drug|High dose of fat-Soluble Vitamin|Supplementation of 5 times current dose of fat-soluble vitamins by intravenous perfusion
15870656|NCT03876704|Drug|Conventional dose of fat-Soluble Vitamin|Supplementation of the current dose of fat-soluble vitamins by intravenous perfusion
15870657|NCT03876691|Other|Patients|Patients who are considered as terminally ill and would not benefit from aggressive treatment, who physicians suggest to family about a do-not-resuscitate.
15870658|NCT03876691|Other|Physician|The current emergency medical department departments within the preparation of the attending physician
15870659|NCT03876678|Other|Lactobacillus Salivarius AP-32|Taking 1 probiotic capsule two times everyday for 7 days.
15870660|NCT03876678|Other|Bifidobacterium Animalis subspecies Lactis CP-9|Taking 1 probiotic capsule two times everyday for 7 days.
15870661|NCT03876678|Other|Placebo|Taking 1 placebo capsule two times everyday for 7 days.
15870662|NCT03876665|Other|No intervention|No intervention
15870663|NCT03876652|Device|Pacemaker with Closed Loop Stimulation (CLS)|In active mode of closed loop sensor (CLS), evaluate its impact on quality of life and recurrence of syncope.
15870664|NCT03876639|Other|Application of emulsion|Daily application of the assigned formulation on the non-dominant volar forearm for 4 weeks
15870665|NCT03876639|Procedure|Measurement of physiological skin parameters|Weekly measurement of physiological skin parameters using confocal Raman spectroscopy, Corneometer® CM 825, Sebumeter®, Skin-pH-Meter®, AquaFlux® and Epsilon®
15870666|NCT03876639|Procedure|Tape stripping|Removal of 40 adhesive strips after application of a model drug-loaded emulsion and determination of the transepidermal water loss
15870667|NCT03876626|Other|PositiveLinks RX Mobile App|A mobile app designed with tools to facilitate patient self-monitoring, patient-provider communication, medication refills, and social support.
15870668|NCT03876626|Other|PositiveLinks RX Portal|An online portal that interacts with the mobile app to enable users to engage with participants though messaging and medication refill tracking.
15870669|NCT03876613|Behavioral|Different music types|the type of music that reduces anxiety best and most effectively.
15870670|NCT03876600|Procedure|Replacement of permanent pacemakers for elective wear.|"START's intervention is a replacement of permanent pacemakers for elective wear, for the both arms the surgical intervention is the same. The surgical procedure is the same in the both arms.
~The differences are in conventional hospitalization, patient comes to hospital one day before operation and he can go out one day after operation. In ambulatory patient come to hospital operation days and he can got out the same day."
15870671|NCT03876587|Drug|Pyrotinib Maleate combine with Docetaxel|Pyrotinib Maleate combine with Docetaxel as the first-line treatment to HER2-positive Metastatic Breast Cancer
15870672|NCT03876574|Procedure|DSA-guided implantation of hepatic artery infusion pump|Implant the infusion catheter and injection port (Celsite, B. Braun, Chasseneuil, France) under DSA-guiding. The proximal end of the infusion catheter was connected to the injection port and the device was implanted in a subcutaneous pocket in the right inner thigh; the distal end of the infusion catheter guarantee uni-direction infusion to liver.
15870673|NCT03876574|Drug|Gemcitabine|Given intra-arterially for 30 minutes
15870674|NCT03876574|Drug|Floxuridine|Given intra-arterially continuously for 14 days
15870675|NCT03876574|Drug|dexamethasone|Given intra-arterially continuously with 5-FUDR
15870676|NCT03876561|Procedure|Pelvic floor prehabilitation|The systematic pelvic floor prehabilitation will start 4 weeks before stoma closure and will include 1 session per week before stoma closure and 1 session per week during 6 weeks following stoma closure. The prehabilitation will be performed according to a predefined protocol based on a biofeedback strategy.
15870677|NCT03876548|Device|Cadexomer Iodine Gel|Subjects will apply gel product to keloid scar site every other day for 28 days following keloid scar revision surgery.
15870678|NCT03876535|Other|Nanomix eLab® System molecular diagnostic test (non-interventional)|This is not an interventional study. It involves performance equivalence demonstration of a point of care diagnostic system to FDA cleared predicate devices currently used in sepsis and SIRS diagnosis.
15870679|NCT03876509|Diagnostic Test|Impedance Cardiography|"Impedance Cardiography will be conducted in patients with suspected Pulmonary Hypertension within an interval of 24 hours to right-heart catheterization. Usually, 8 electrodes will be attached on the neck and thorax of the patient. These electrodes will produce current (max 400µA) and measure the voltage which is produced by the current running through the body. The Signal will be analyzed for specific signs of Pulmonary Hypertension.
~At the same time electrocardiography and non-invasive continuous blood pressure will be measured."
15870680|NCT03876496|Device|SensableCare System|"The Sensable®Care Mattress has sensors embedded in it. Sensable®Care System is able to identify if the subject is stirring in bed, sitting up from the bed, attempting to leave the bed, or being out of the bed. If the subject is found to be in any of these four scenarios, four different types of alerts/notifications will warn clinicians: Stirring Notification, Sitting Up Notification, Bed Leaving Alert, Out of Bed Alert, will be generated by Sensable®Care System respectively.
~Once these four alerts/notifications are generated, designated attending nurses or caregivers equipped with a mobile app will receive audible, vibratory, and/or visual alerts from the Dashboard with subject's room number and type of alert displayed mobile app. Thus, interventions/assistance can be carried out presumably early. Harm to patient safety may be prevented."
15870682|NCT03876470|Other|Hepatitis C treatment as chosen by provider|Participants' providers will determine the type of HCV treatment as appropriate.
15870683|NCT03876457|Device|Endovascular Thrombectomy|Patients randomized to endovascular thrombectomy arm will receive thrombectomy plus medical management. They will be treated with thrombectomy devices (stent-retrievers or aspiration devices) currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke within 24 hours of symptom onset. The devices which will be used are FDA-approved stent retrievers: the Trevo Retriever, the Solitaire Revascularization Device, EmboTrap Revascularization Device and Tigertriever Revascularization Device; and/or the aspiration devices approved by the FDA (e.g. MicroVention SOFIA Catheter, and the Penumbra thrombectomy system). The choice of thrombectomy method, primary approach/technique, whether primary aspiration or primary stent-retriever with or without aspiration, will be left up to the interventionalist, with any of the FDA-approved devices approved in the study protocol or a combination of them.
15870684|NCT03876457|Other|Medical Management|Patients will receive standard AHA guideline-directed medical therapy, which will include IV thrombolytic therapy available for use according to practice guidelines in patients presenting within the first 3 hours from last-seen-normal and meeting other FDA label criteria, or up to 4.5 hours from last-seen-normal and meeting other AHA guidelines. For non-thrombolysis treated patients, this will include aspirin 325 mg on day 1 followed by aspirin 81 mg or 325 mg thereafter, which will be determined by treating physician and standard deep venous thrombosis prevention therapy. Intravenous anticoagulation and dual anti-platelet therapy will be discouraged without clear documented reasoning. Post-thrombolysis patients will be treated based on standard study site protocols for these patients.
15870685|NCT03876444|Drug|Intravenous Methylprednisolone|Intravenous Methylprednisolone will be used in the intervention group
15870686|NCT03876444|Drug|Oral Pednisolone|Oral Prednisolone will be used in the Control Group
15870687|NCT03876431|Device|Easy-Flex|The Easy-Flex device will be used to increase knee flexion and extension ROM.
15870688|NCT03876431|Other|Exercise|After total knee replacement surgery, exercise program including strengthening, stretching and patient training will be applied.
15870689|NCT03876418|Diagnostic Test|Intra-abdominal Pressure|Aggressive screening, prevention and treatment of intra-abdominal hypertension
15870690|NCT03876405|Device|smartskin non-invasive sensory feedback|"The sensory feedback system used was a simple non-invasive, non-electronic system based on air-mediated pressure. A silicone glove with bulbs (35 mm in length) volar in every fingertip was made and applied on a VariPlus Speed hand (OttoBock), size 7¾.
~The sensory feedback system was embedded in the prosthetic socket."
15870691|NCT03876392|Diagnostic Test|magnetic resonance imaging|Compare bone marrow biopsy with magnetic resonance imaging to detect bone marrow metastases
15870692|NCT03876366|Other|online survey|Part 1: online survey (quantitative) with questions on basic socio-demographic data, medical data and family characteristics (e.g. age, ethnicity, education) and information about FP.
15870779|NCT03875625|Behavioral|Dietitian led life style modification intervention|Intensive 6 months life style changes supervised by diatitians.
15870693|NCT03876366|Other|focus group meeting|Part 2: At the end of the online survey, participants are invited to attend one of the consecutively performed focus groups conducted according to standardized focus group methodology and moderated by a clinical psychologist and a specialist in reproductive medicine.
15870694|NCT03876353|Other|Floss|All participants will have half of their mouth flossed. Each participant will act as their own control.
15870695|NCT03876340|Other|Treatment algorithm|Digital infrared thermograms will be obtained during the first contact with the patients. Temperature recordings of the injured and healthy skin will be used to calculate the temperature difference between the structures. The thermograms will be used to dictate the initial treatment.
15870696|NCT03876340|Other|Current treatment|Digital infrared thermograms will be obtained during the first contact with the patients. Temperature recordings of the injured and healthy skin will be used to calculate the temperature difference between the structures, but the results will be kept sealed until the study is finished. The patients will receive the usual standard of care as dictated by the surgical team.
15870697|NCT03876327|Procedure|fecal microbial transplantation|Fecal microbiota transplantation (FMT) is a technique in which intestinal microbiota are transferred from a healthy donor to the patient, with as primary goal to introduce - or restore - a stable and 'healthy' microbial community in the gut.
15870698|NCT03876314|Behavioral|Physical Activity Condition|Subjects will attend virtual group exercise sessions 3x/week for 1 year. Each subject will be encouraged to walk at a moderate intensity (target heart rate (HR)= 40-59% HR reserve) dependent on resting HR and age. Subjects will perform aerobic exercise on their own and resistance exercises will be completed in virtual exercise sessions with an instructor 1 hour/day for 3 days/week for 1 year. At the exercise sessions, these participants will be asked to record measures of the exercises completed and may be asked to provide measures of heart rate (assessed by palpation for 20-seconds) and rate of perceived exertion (RPE). They will be asked to submit exercise logs providing this information. Data from exercise logs and exercise specialist records will be reviewed for evidence of progression, consistent attainment of moderate intensity, and with respect to the prescribed duration of the aerobic and strength training components.
15870699|NCT03876301|Drug|Standard of Care FVIII Replacement therapy|There is no investigational product being administered. Subjects will be administering their own standard of care FVIII replacement therapy.
15870700|NCT03876288|Device|GI Neuromodulation|The investigators would include follow up with: No treatment; temp GES only; temp followed by Perm GES; Other device therapies; specific pain therapies; drug therapies, including investigational drugs; immunotherapy; pyloric therapies; psychological/behavioral therapies; nutritional support; radiological and surgical therapies; infection rates related to procedures; if enrolled in any therapy research trials; morbidity and mortality after specific therapies; other treatments used.
15870701|NCT03876288|Drug|Immunotherapy|The investigators would include follow up with: No treatment; temp gastric electrical stimulation (GES) only; temp followed by Perm GES; Other device therapies; specific pain therapies; drug therapies, including investigational drugs; immunotherapy; pyloric therapies; psychological/behavioral therapies; nutritional support; radiological and surgical therapies; infection rates related to procedures; if enrolled in any therapy research trials; morbidity and mortality after specific therapies; other treatments used.
15870702|NCT03876288|Procedure|Pyloric Therapies|The investigators would include follow up with: No treatment; temp gastric electrical stimulation (GES) only; temp followed by Perm GES; Other device therapies; specific pain therapies; drug therapies, including investigational drugs; immunotherapy; pyloric therapies; psychological/behavioral therapies; nutritional support; radiological and surgical therapies; infection rates related to procedures; if enrolled in any therapy research trials; morbidity and mortality after specific therapies; other treatments used.
15870703|NCT03876262|Drug|Moxidectin|2mg tablets, encapsulated for blinding
15870704|NCT03876262|Drug|Ivermectin|3mg tablets, encapsulated for blinding
15870705|NCT03876249|Other|exposure to RSV|No intervention will be given, children naturally exposed to RSV in their early life
15870706|NCT03876210|Combination Product|PK101|PK101-001 + PK101-002 (combination)
15870707|NCT03876210|Drug|PK101-001, PK101-002|coadministration
15870708|NCT03876197|Biological|Autologous adipose-derived mesenchymal stem/stromal cells|Autologous adipose-derived mesenchymal stem/stromal cells
15870709|NCT03876197|Other|Placebo|Isotonic NaCl (0,9mg/ml) and human albumin (HA) 1%
15870710|NCT03876184|Other|Aesthetic archwires|During bond-up, randomly allocated envelope will be opened and archwires will be ligated with elastomeric ligatures.After 4 weeks,the same archwires will be retied.Any fractured archwire will be recorded and discarded.The fractured wire will be replaced with conventional archwire and treatment continues.On the 2nd follow-up (at 8th week), the tested wires are collected, disinfected, dried and placed back in the allocated envelope.Upper and lower impressions will be taken.Questionnaires will be answered by participants.The trial ends and treatment continues as planned.Fractured archwire will be recorded and discarded.
15870711|NCT03876184|Other|Control group|During bond-up, randomly allocated envelope will be opened and archwires will be ligated with elastomeric ligatures.After 4 weeks,the same archwires will be retied.Any fractured archwire will be recorded and discarded.The fractured wire will be replaced with conventional archwire and treatment continues.On the 2nd follow-up (at 8th week), the tested wires are collected, disinfected, dried and placed back in the allocated envelope.Upper and lower impressions will be taken.This group will not answer the questionnaire.The trial ends and treatment continues as planned.Fractured archwire will be recorded and discarded.
15870712|NCT03876171|Behavioral|Haitian youth and family intervention study: family functioning|A weekly group therapy with the youth, the parents and other members of the family.
15870713|NCT03876171|Behavioral|Haitian youth intervention study: youth psychoeducational|Weekly one and one psychoeducational module will be delivered to the youth.
15870714|NCT03876171|Behavioral|Haitian family intervention study: family psychoeducational|Weekly psychoeducational module will be delivered to the family.
15870715|NCT03876171|Behavioral|Diversion Programs|Youth will attend individual psychological counselling at an assigned Juvenile Services Department (JSD) diversion program.
15870716|NCT03876158|Device|Prometra II Programmable Pump system(Flowonix Medical)|This valve gated Prometra II Programmable Pump system will be replacing prior peristaltic Synchromed II pump
15870780|NCT03875625|Behavioral|Conventional care (control)|receive routine care
15870781|NCT03875599|Other|Pulmonary Rehabilitation|Respiratory Physiotherapy, Exercise Therapy, Patient Education
15870717|NCT03876145|Other|Minimal ovarian stimulation|After obtaining informed consent to participate in the study, the subjects will be randomly divided into the following 4 groups: The group of minimal ovarian stimulation with rec-FSH or HMG. The group of mild ovarian stimulation with rec-FSH or HMG. In all 4 experimental groups, after reaching at least three follicles the size of 12 millimeters (mm), daily administration of 0.25 milligram (mg) Cetrotide (antagonist GnRH) will be started and after reaching at least three follicles the size of 17 mm, 500 microgram Ovitrelle (recombinant Human curionic gonadotropin) will be prescribed. 36 hours later, ovulation process will be done. On the day of Ovitrelle administration, serum levels of estradiol and progesterone will be also evaluated. Based on the patient's condition and the quality of obtained oocytes and embryos, 2 embryos will be transferred.
15870718|NCT03876119|Drug|Intraarterial alteplase|See arm/group descriptions.
15870719|NCT03876119|Drug|Placebo|See arm/group descriptions.
15870720|NCT03876106|Drug|LUT014|Topical
15870721|NCT03876080|Other|Dry needling|The use of a solid filiform needle to treat trigger points
15870722|NCT03876080|Other|Sham needling|Simulated needling
15870723|NCT03876067|Drug|Ozone|"Our procedures for O3T application in CBP surgery conform to international guidelines of the ''Madrid Declaration on Ozone Therapy'' 32 . M-O3T will be carried out as follows:
~50mL of blood drawn by vacuum from the patient central catheter into a sterile blood transfusion bag in which 10 mL of 3.8% Na citrate solution (Galenica Senese Industries, Siena, Italy) as an anticoagulant will be previously added so that the blood/citrate volume ratio was 9:1. After blood withdrawal, the bag will momentarily disconnected leaving the venous access open by a saline infusion 33 . A corresponding volume (50 mL) of gas was immediately added with an O3 concentration of 20-50 micrograms/mL gas. Ozone was produced by Medozon compact generator (Herrmann Apparatebau GmbH, Germany).
~At this point, the hyper-oxygenated ozonated blood will be mixed with the cold cardioplegia (Thomsons cardioplegia) this amount of ozonated blood will be added to each 500 ml of cardioplegic solution"
15870724|NCT03876067|Drug|Cardioplegic Solutions|in which in which only cold blood cardioplegia
15870727|NCT03876041|Drug|solumedrol|intravenous solution for injection
15870728|NCT03876041|Drug|Dexamethasone phosphate|intravenous solution for injection
15870729|NCT03876028|Biological|Tisagenlecleucel|Infusion
15870730|NCT03876028|Drug|Ibrutinib|Oral (tablets or capsules)
15870731|NCT03876015|Drug|Semaglutide|Patients will be treated with commercially available semaglutide in a prefilled pen injector (FlexTouch® variant) according to routine local clinical practice at the discretion of the treating physician. Other anti-hyperglycaemic treatments will be prescribed at the physician's discretion.
15870732|NCT03876002|Drug|[18F]PBR06|Subjects will undergo PET imaging using 1 single intravenous (IV) injection of [18F]PBR06, a PET radioligand for evaluation of microglial activation in the brain. PBR06 will be injected intravenously as a bolus at a dose of no more than 5.5mCi (millicurie).
15870733|NCT03875989|Procedure|Anterior colporraphy|It will be delimitate a rectangular vaginal strip which will be isolated from the anterior colpocele. The superior edge of the strip is placed 2 cm from the urethral orifice. After lateral vesico-vaginal dissection, the paravesical fossae will be wide opened to repair the tendinous arches. The vaginal plastron will be fixed to the tendinous arch of the pelvic fascia by 3 lateral stitches (anterior/ lateral/ posterior) on each side of the plastron. After, the plastron will be tensioning and the cystocele will be suspended. The closure of the vaginal wall will end the procedure.
15870734|NCT03875989|Procedure|vaginal patch plastron|It will be make a midline incision of the anterior vaginal wall from the urethrovesical junction to the vaginal apex or anterior fornix. The vaginal epithelium will be separated from the underlying fibromuscular layer (Halban Fascia) after the midline incision. Midline plication of the fibromuscular layer will be obtained by interrupted horizontal stiches. The closure of the vaginal wall will end the procedure.
15870735|NCT03875976|Procedure|Fast Track Protocol|Fast Track Care consists in educational preoperative preparation for patients, particular strategies for controlling pain and intensive early rehabilitation protocol
15870736|NCT03875976|Procedure|Standard Care Protocol|Standard Care Protocol consists in the same surgical intervention without educational preoperative preparation for patients and intensive early rehabilitation protocol
15870737|NCT03875963|Other|Antibiotic loaded bone filler|Defect management by placement of antibiotic loaded Stimulan as a bone void filler [calcium sulfate bone void filler (10 cc of STIMULAN(R) Rapid Cure, Biocomposites Ltd, UK) combined with the following antibiotic combination: 1g Vancomycin, 240mg Tobramycin].
15870738|NCT03875950|Behavioral|Clinician training intervention|This intervention is a clinician training using standardized patient actors to improve communication and empathy skills of health care workers delivering PrEP to adolescent girls and young women to prevent HIV in Kenya.
15870739|NCT03875937|Drug|Tranexamic 1 gram|To be administered intramuscularly (2 injections)
15870740|NCT03875924|Other|VWD treatments|Modalities and types of treatments in VWD patients for severe hemorrhagic events: INN, quantities, duration of treatment
15870741|NCT03875911|Drug|Mitomycin C|Three delivery methods of Mitomycin-C in Trabeculectomy
15870742|NCT03875898|Other|150 g bread fortified (15 g mix fibre)|Daily consumption of 150g of a bread fortified in fibre mix (15g) during eight weeks.
15870743|NCT03875898|Other|150 g unfortified bread|Daily consumption of 150g of an usual bread in fibre-unfortified bread during eight weeks
15870744|NCT03875885|Behavioral|CONNECT|A novel web-based intervention with input from an advisory panel of cancer caregivers, oncology providers, and psychosocial oncology professionals empowering caregivers with needs to seek services by providing education about the benefits of supportive care resources, systematically identifying their unmet needs, and connecting them with tailored supportive care resources.
15870745|NCT03875885|Behavioral|CONTROL|This group will receive a generic resource list. The generic resource list will be printed for participants and emailed to them, if participants have an email address.
15870746|NCT03875872|Drug|Propofol|Patients who had surgeries and were anaesthetized with propofol at Queen Mary Hospital, Hong Kong from Jan 2015 to Dec 2017
15870747|NCT03875872|Drug|inhalation anaesthetics|Patients who had surgeries and were anaesthetized via inhalation at Queen Mary Hospital, Hong Kong from Jan 2015 to Dec 2017
15870749|NCT03875846|Diagnostic Test|Intraoperative Hemodynamic Pressures|Secondary analyses will examine the Ankle-Brachial Index, and the absolute limb pressures. In addition, the changes in flow rate of contrast before- and after- intervention will be examined as an indicator of perfusion.
15870750|NCT03875846|Diagnostic Test|Contrast Flow Rate|A secondary analysis will examine the rate of contrast flow during pre-intervention and post-intervention angiograms, and correlate these findings with hemodynamic measurements recorded during surgery.
15870751|NCT03875833|Device|Collagen Nerve Wrap Conduit|The collagen nerve wrap conduit will be placed on all exposed radial and ulnar nerves at the time of free flap harvest.
15870752|NCT03875820|Drug|RO5126766|"RO5126766 will be supplied as 0.8mg hypromellose (HPMC) capsules for oral administration. The capsule fill consists of RO5126766 and the inactive ingredients mannitol and magnesium stearate.
~RO5126766 will be administered on a twice weekly (Monday and Thursday or Tuesday and Friday) schedule for 3 weeks followed by 1 week off in every 4 week cycle, under fasting conditions (approximately 1 hour prior or 2 hours after a meal). The starting dose, based on the previous Phase I trial will be 3.2 mg given orally as a single daily dose. This can be escalated to a maximum of 4mg (as per dose escalation rules in the protocol)."
15870753|NCT03875820|Drug|VS-6063|"VS-6063 is formulated as a white to off-white oval tablet for oral administration and supplied in single unit dose strength of 200 mg in 120 cc (HDPE) bottles. In addition to VS-6063, formulation components include microcrystalline cellulose, lactose monohydrate, sodium starch glycolate, and magnesium stearate.
~Patients will receive VS-6063 orally immediately after a meal twice daily (approximately every 12 hours) for 3 weeks followed by 1 week off in every 4 week cycle. The starting dose will be 200mg. This can be escalated to a maximum of 400mg (as per dose escalation rules in the protocol)."
15870754|NCT03875807|Procedure|ACLR done at 0 degrees KFA|Patients randomized to this arm will undergo the following intervention: Anterior Cruciate Ligament Reconstruction (ACLR) done at 0 degrees knee angle flexion (KFA)
15870755|NCT03875807|Procedure|ACLR done at 30 degrees KFA|Patients randomized to this arm will undergo the following intervention: Anterior Cruciate Ligament Reconstruction (ACLR) done at 30 degrees knee angle flexion (KFA)
15870756|NCT03875794|Other|Osteopathic Manipulation|Using osteopathic manipulation as an intervention to increase milk supply in lactating women.
15870757|NCT03875781|Drug|Chemotherapy|"Arm A : Experimental
~Intervention Type : Drug
~Intervention Name : Modified FOLFIRINOX (experimental arm)
~Intervention Description : preoperative chemotherapy: Modified FOLFIRINOX regimen comprised oxaliplatin 85mg/m2 + irinotecan 180mg/m2 + Folinic acid 400 mg/m2 at day1, then 5-FU given as a continuous infusion over 46h every two weeks. Six cycles are planned preoperatively."
15870758|NCT03875781|Drug|Radiochemotherapy|"Arm B: Active comparator
~Intervention Name : modified FOLFIRINOX followed by preoperative standardized radiochemotherapy (control arm)
~Intervention Description : preoperative chemotherapy: Modified FOLFIRINOX regimen comprised oxaliplatin 85mg/m2 + irinotecan 180mg/m2 + Folinic acid 400 mg/m2 at day1, then 5-FU given as a continuous infusion over 46h every two weeks. Six cycles are planned preoperatively.followed by preoperative radiochemotherapy with concurrent capecitabine 825 mg/m2/12h 5 days/week and intensity modulated radiation therapy using a simultaneous integrated boost technique with 45 Gy in 25 fractions in pelvic volume and 50 Gy in 25 fractions to the tumor."
15870759|NCT03875768|Behavioral|Tracking plus coaching|Participants will track their nutrition intake every day for six months using a study app and receive tailored feedback via text message based on their nutritional intake and adherence to the DASH dietary pattern. If necessary, they will receive responsive coaching from a Nourish registered dietitian in order to increase adherence to the DASH dietary pattern and their engagement with the intervention.
15870760|NCT03875755|Dietary Supplement|Myo Inositol|One soft gel capsule containing MI 600 mg and folic acid 200 μg twice a day, until delivery.
15870761|NCT03875755|Other|Placebo|One soft gel capsule of placebo (folic acid 200 μg) twice a day until delivery.
15870762|NCT03875742|Device|Ultraplex 360(Braun)|"This group will use as first needle the ultraplex 360 (Braun)"
15870763|NCT03875742|Device|STIMUPLEX D SH, 30°(Braun)|"This group will use as first needle the  STIMUPLEX D SH, 30° (Braun)"
15870764|NCT03875729|Biological|teplizumab|Treatment
15870765|NCT03875729|Biological|Placebo|Control
15870766|NCT03875716|Radiation|Radiation therapy|Radiation therapy
15870767|NCT03875690|Drug|Injection of methylprednisolone|Patients will receive 20mg/kg IV of methylprednisolone at the time of anaesthetic induction. Methylprednisolone will be infused in a ready-to-use 50 mL bag of sodium chloride 0.9% during 30 minutes at anaesthesic induction.
15870768|NCT03875690|Drug|Injection of sodium chloride|patients in the placebo group will receive 50 mL of sodium chloride 0.9% in a ready-to-use bag during 30 minutes at anaesthesic induction.
15870769|NCT03875690|Biological|Blood samples|electrolyte panel and glycemia performed within the first 24 hours after surgery.
15870770|NCT03875677|Device|HD-tDCS group|5 sintered Ag/AgCl ring electrodes will be used at a radius of ~5cm. The electrodes will be placed inside plastic electrode holders which will be filled with gel to have better contact with the scalp.
15870771|NCT03875677|Device|Conventional tDCS group|A pair of 25 cm2 rubber electrodes enclosed in saline-soaked sponges and affixed to the head with rubber bands.
15870772|NCT03875677|Device|Sham HD-tDCS group|A pair of 25 cm2 rubber electrodes enclosed in saline-soaked sponges and affixed to the head with rubber bands.
15870773|NCT03875664|Drug|Liposomal bupivacaine|Extended-release local anesthetic
15870774|NCT03875664|Drug|Placebo - injection|Injectable normal saline solution
15870776|NCT03875638|Drug|Levetiracetam|Levetiracetam is an antiepileptic medication that has been shown to reduced network cortical hyperexcitability
15870777|NCT03875638|Drug|Placebo oral capsule|The placebo is a capsule that is identical in appearance to the levetiracetam
15870778|NCT03875625|Procedure|Bariatric surgery|Use of the normal bariatric surgery procedures commonly conducted in our hospital, such as: Laparoscopic Roux-en-Y gastric bypass (RYGB) and Laparoscopic sleeve gastrectomy (LSG)
15870782|NCT03875573|Drug|Durvalumab|an anti PD-L1 intravenous administration at 1500 mg every 4 weeks for 19 weeks.
15870783|NCT03875573|Radiation|Stereotactic Body Radiotherapy|Pre-operative radiation therapy (boost dose) 3x8 Gy on the primary tumour at week 5 given in 3 fractions. The 3 fractions will be spread at the minimum over 3 days and at the maximum over 6 days.
15870784|NCT03875573|Drug|Oleclumab|an anti-CD73 intravenous administration at 3000 mg every 2 weeks for the first 4 administrations then every 4 weeks for the last 3 administrations.
15870785|NCT03875560|Biological|IC14|recombinant chimeric anti-human CD14 monoclonal antibody
15870786|NCT03875560|Drug|Placebo|Inactive
15870787|NCT03875547|Drug|Refixia®|Patients will be treated with commercially available Refixia® according to routine clinical practice at the discretion of the treating physician
15870788|NCT03875508|Drug|Risankizumab|Risankizumab to be injected subcutaneously (SC)
15870789|NCT03875508|Device|Autoinjector|Single dose pre-filled autoinjector containing risankizumab for SC injection
15870790|NCT03875495|Drug|Temferon|Genetically modified autologous HSPCs
15870791|NCT03875482|Drug|Risankizumab|Risankizumab 150 mg (150 mg/mL) in prefilled syringes, self-administered subcutaneously
15870792|NCT03875482|Drug|Placebo solution for risankizumab|Placebo solution in prefilled syringes, self-administered subcutaneously
15870793|NCT03875469|Device|Centargo injector (BPI 1000045)|Contrast-enhanced computer tomography conducted with Centargo injector
15870794|NCT03875469|Device|Stellant MP injector|Contrast-enhanced computer tomography conducted with Stellant MP injector
15870795|NCT03875443|Other|Instructional video|Video (produced by AO Trauma and Prof. Daniel Rikli) includes a stepwise and structured explanation of the different fluoroscopic views necessary to evaluate intraoperatively with the fluoroscope different aspects of the proximal femur. The video is publically available under: (https://www.aointeract.org/#/watch/video/L3YxL3ZpZGVvcy8xOTc=/intraoperative-imaging-of-femur).
15870796|NCT03875443|Other|Reduction algorithm|Intraoperative reduction algorithm (developed by PD Henrik Eckardt); each step in the algorithm will be checked and documented with the fluoroscope and archived using the store function of the fluoroscope.
15870797|NCT03875430|Dietary Supplement|Humulus lupulus L|Patients with this intervention will receive a dietary supplement to relieve the symptoms of menopause
15870798|NCT03875417|Procedure|liver resection|resection of one or more HCC nodules within the liver
15870799|NCT03875417|Procedure|Thermic ablation|ablation of HCC nodule through a percutaneous needle, by using radiofrequency or microwaves
15870800|NCT03875417|Procedure|Transcatheter arterial chemoembolization|embolization of HCC nodule via drug-eluted microbeads.
15870801|NCT03875404|Diagnostic Test|Functional MRI|A special type of MRI measuring the metabolic changes that occur within the brain. It may be used to examine the brain's anatomy and determine which parts of the brain are handling critical functions. It helps identify important language and movement control areas in the brain.
15870802|NCT03875391|Drug|Oxytocin|Drug: Oxytocin nasal spray
15870803|NCT03875391|Drug|Placebo|Drug: Placebo nasal spray
15870804|NCT03875378|Drug|Transdermal estrogen|Transdermal estradiol (0.045mg)/levonorgestrel (0.015mg) weekly patch
15870805|NCT03875378|Drug|Placebos|Placebo weekly patch
15870806|NCT03875365|Procedure|POPE|Patients who have undergone Per-oral Plication of the Esophagus (POPE) procedure.
15870807|NCT03875352|Procedure|CHG technique|The CHG technique includes treatment using dressing with chlorhexidine.
15870808|NCT03875352|Procedure|HMG technique|The HMG technique includes treatment using hydrophilic methacrylate gel and transparent foil.
15870809|NCT03875339|Behavioral|Navigator Guidance|Use of a dedicated Navigator to determine if follow-up and compliance rates can be improved for those infants initially demonstrating an abnormal hearing result.
15870810|NCT03875326|Device|1 mA HD-tDCS|Participants will receive HD-tDCS at 1 mA for 30 minutes, for between 5-30 sessions.
15870811|NCT03875326|Device|2 mA HD-tDCS|Participants will receive HD-tDCS at 2 mA for 30 minutes, for between 5-30 sessions.
15870812|NCT03875326|Device|3 mA HD-tDCS|Participants will receive HD-tDCS at 3 mA for 30 minutes, for between 5-30 sessions.
15870813|NCT03875326|Device|Sham|Participants will receive sham (placebo) HD-tDCS for 30 minutes, for between 5-30 sessions.
15870814|NCT03875313|Drug|CB-839|CB-839 oral tablets administered twice daily with food at the assigned dose level on 28 day cycles with talazoparib.
15870815|NCT03875313|Drug|Talazoparib|Talazoparib oral tablets administered at the standard dose once daily with or without food on 28 day cycles with CB-839.
15870816|NCT03875300|Behavioral|Foodwise in Pregnancy|A 7 week programme of nutrition and lifestyle advice, delivered in community venues by trained Healthy Lifestyle Support Workers (HLSWs). Participants must meet study inclusion criteria.
15870817|NCT03875287|Drug|Decitabine|"DOSING REGIMEN(S):
~Level -1 10mg daily days 1-4
~Level 1 10mg daily days 1-5
~Level 2 15mg daily days 1-5
~Level 3 20mg daily days 1-5"
15870818|NCT03875287|Drug|Cedazuridine|"DOSING REGIMEN(S):
~Level -1 100mg daily days 1-4
~Level 1 100mg daily days 1-5
~Level 2 100mg daily days 1-5
~Level 3 100mg daily days 1-5"
15870819|NCT03875274|Drug|Ropivacaine, Morphine|Morphine added to ropivacaine for fascia iliaca compartment block
15870820|NCT03875274|Drug|Ropivacaine, Saline|Normal saline added to ropivacaine for fascia iliaca compartment block
15870821|NCT03875261|Drug|Cannabinoid treatment|Participants are treated with cannabinoid derivates with a dose between 1 to 12 puffs, each puffs contains 2,7 mg of delta-9-tetrahidrocannabinol and 2,5 mg of cannabidiol.
15870822|NCT03875248|Device|Blood pressure measurement|Measure optically the blood pressure through the use of a smartphone
15870823|NCT03875235|Drug|Durvalumab|IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
15870824|NCT03875235|Drug|Placebo|IV infusion every 3 weeks with gemcitabine plus cisplatin up to 8 cycles followed by monotherapy every 4 weeks until disease progression or other discontinuation criteria.
15870825|NCT03875209|Biological|10E8.4/iMab|bispecific monoclonal antibody
15870826|NCT03875196|Device|Pelvic Floor Muscle Training With Biofeedback|Biyofeedback: The Biyofeedback allows the patient to see the results of her behavior immediately By a perineometer device or electromyelography that is placed in the vagina, the patient sees how she hears the pelvic floor muscles, hears the sound or hears her voice, and detects how much she needs to contract.
15884473|NCT03770299|Drug|Paclitaxel|Specified dose on specified days
15870827|NCT03875196|Device|Extracorporeal Magnetic Innervation|Extracorporeal Magnetic Innervation: The patients are seated in a special chair connected to an external power unit and a magnetic field generator inside with their clothes on. In order to coincide the spreading magnetic field with pelvic floor muscles, the urethral and anal sphincters, the perineum of the patients should be placed in the center of the chair. In this way, the perineum tissues are stimulated by emitted magnetic field waves. Thus no electrical current passes through the device to the patient's body and the patient is exposed to only the magnetic current.
15870828|NCT03875183|Drug|INL1|Capsules
15870829|NCT03875183|Other|Placebo|Capsules
15870830|NCT03875170|Other|Experimental|The technique will be carried out with the subjects in the positions of supine, prone and lateral position, for the flexor muscles of the hip, hamstrings and quadriceps, where the musculature and the joint to be treated will be taken to a range of functional mobility. The subject will be asked to perform an isometric contraction, with a series of 3 seconds for sustained contraction and a rest between contraction of 2 to 3 seconds after activating the Golgi apparatus, making an inhibition of the stimulus and bringing the joint and muscle to the highest possible range of motion without pain.
15870831|NCT03875170|Other|Control|The active stretching technique will be performed for the hip, quadriceps and hamstring flexors with a voluntary antagonist activation to relax the agonist muscle, holding the movement to be performed for 30 seconds to stimulate the neuromuscular spindle and produce a relaxation of the muscle fibers.
15870832|NCT03875157|Biological|IBI318|0.3mg Intravenous infusion, first day of first cycle and afterwards Q2W
15870833|NCT03875157|Biological|IBI318|1mg Intravenous infusion, first day of first cycle and afterwards Q2W
15870834|NCT03875157|Biological|IBI318|3mg Intravenous infusion, first day of first cycle and afterwards Q2W
15870835|NCT03875157|Biological|IBI318|10mg Intravenous infusion, first day of first cycle and afterwards Q2W
15870836|NCT03875157|Biological|IBI318|30mg Intravenous infusion, first day of first cycle and afterwards Q2W
15870837|NCT03875157|Biological|IBI318|100mg Intravenous infusion, first day of first cycle and afterwards Q2W
15870838|NCT03875157|Biological|IBI318|300mg Intravenous infusion, first day of first cycle and afterwards Q2W
15870839|NCT03875157|Biological|IBI318|600mg Intravenous infusion, first day of first cycle and afterwards Q2W
15870840|NCT03875157|Biological|IBI318|Intravenous infusion, first day of first cycle and afterwards Q3W
15870841|NCT03875157|Biological|IBI318|Intravenous infusion, first day of first cycle and afterwards Q3W
15870842|NCT03875157|Biological|IBI318|Intravenous infusion Q3W
15870843|NCT03875144|Procedure|PIPAC|Pressurized IntraPeritoneal Aerosol Chemotherapy of Cisplatin 10.5mg/m² + Doxorubicin 2.1 mg/m² every 6 weeks
15870844|NCT03875144|Drug|Cisplatin|standard intravenous chemotherapy for mesothelioma (Cisplatin 75mg/m² + Pemetrexed 500mg/m²)
15870845|NCT03875144|Drug|Pemetrexed|standard intravenous chemotherapy for mesothelioma (Cisplatin 75mg/m² + Pemetrexed 500mg/m²)
15870846|NCT03875131|Other|Biomarkers of Dementia and Cognitive Decline|"Biomarkers will be obtained at baseline, 6, 12, 18, and 24 months.
~The six questionnaires listed below will be administered at the baseline visit, and repeated at the 24-month visit to evaluate cognitive decline.
~Mini-Mental Status Evaluation
~Hachinski Ischemic Scale
~Cognitive Subscale of Alzheimer's Disease Assessment Scale
~Disability Assessment for dementia
~Quality of life improvement as assessed by:
~Minnesota Living with Heart Failure Scale
~Anti-Clot Treatment Scale (ACTS) Quality of Life Survey"
15870847|NCT03875118|Behavioral|The mouth-opening training with follow-up telephone calls program|Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks. Subjects in the intervention group received additional 6 follow-up phone calls (at 1, 2, 3, 4, 8 and 12-week after discharge) from the interventionist to enhance mouth-opening exercise adherence.
15870848|NCT03875118|Behavioral|The mouth-opening training without follow-up telephone calls program|Subjects in both groups received two 30-minute individual trainings on the mouth-opening exercises before discharge from the hospital. Subjects were instructed to practice the mouth-opening exercises three times a day, every day, for 12 weeks.
15870854|NCT03875079|Drug|RO6874281|"Part I Safety Run in:
~Cohort 1.1: RO6874281 will be administered by intravenous (IV) infusion; 10 mg (Q3W) every 3 weeks and will be observed over 2 administration cycles (i.e. 6 weeks) in order to confirm the safety of the proposed dose and schedule that will be used in Part II of this study.
~Cohort 1.2: RO6874281 will be administered by IV infusion via an induction and maintenance phase; 10 mg (QW) every week for 3 weeks followed by 10 mg (Q3W) every 3 weeks and will be observed over 2 administration cycles (6 weeks) to confirm safety of the proposed dose and schedule to be used in Part III of this study.
~Part II Expansion: RO6874281 will be administered by IV infusion; 10 mg (Q3W) every 3 weeks (or lower dose level depending on Part I Cohort 1.1 outcome).
~Part III Expansion: RO6874281 will be administered by IV infusion; 10 mg (QW) every week or 10mg (Q3W) every 3 weeks (or lower dose level depending on Part I Cohorts 1.1 and 1.2 outcomes) in either a Q3W or QW/Q3W schedule."
15870855|NCT03875079|Drug|Pembrolizumab|"Part I Safety Run in (Cohorts 1.1 and 1.2): Pembrolizumab will be administered by IV; 200 mg Q3W and will be observed over 2 administration cycles (i.e. 6 weeks).
~Part II Expansion: Pembrolizumab will be administered by IV; 200 mg Q3W (or lower dose level depending on Part I Cohort 1.1 outcome)
~Part III Expansion: Pembrolizumab will be administered by IV; 200 mg Q3W (or lower dose level depending on Part I Cohorts 1.1 and 1.2 outcomes)"
15870856|NCT03875066|Other|Stepping training without feedback|Subjects stand in a step standing position with placing one leg on the load cells of the device and the other leg at the posterolateral direction to the trained leg outside the load cells. Then subjects will be instructed to shift/take their body-weight onto the trained leg as most as they can. If the subjects can take a proper level of their body-weight onto the trained leg, the subjects can step the other leg forward to the marker. Then they have to do the same when steps the leg backward.
15870990|NCT03873961|Device|Low-level Laser therapy|tissue photobiostimulation for pain reduction and healing enhancement.
15870857|NCT03875066|Other|Stepping training with feedback|Subjects stand in a step standing position with placing one leg on the load cells of the device and the other leg at the posterolateral direction to the trained leg outside the load cells, look at the displayed section which will be positioned at their eye level. Then subjects will be instructed to shift/take their body-weight onto the trained leg until the green zone of the displayed section is lightened. When the subjects can take a proper level of their body-weight onto the trained leg, the beep sound will be alarmed to trigger the subjects and therapist that the subjects can step the other leg forward to the marker. Then they have to do the same when steps the leg backward.
15870858|NCT03875053|Diagnostic Test|Monitoring Device|Patients wear the home sleep apnea machine overnight. Patients undergoing standard of care CRT wear the home sleep apnea machine a second time 3 months after completion of CRT.
15870859|NCT03875053|Other|Quality-of-Life Assessment|Ancillary studies
15870860|NCT03875053|Other|Questionnaire Administration|Ancillary studies
15870861|NCT03875040|Behavioral|kinesiophobia|patients who have a high-level or low-level kinesiophobia have been evaluated.
15870862|NCT03875027|Procedure|proximal femur replacement|patient with proximal femur fracture or those in whom previous surgery on hip is failed and treated with replacement of proximal femur implant
15870863|NCT03875014|Device|surgery with implant for hip fracture|hip replacement with bipolar hemiarthroplasty or total hip arthroplasty dual mobility done and patients was followed
15870864|NCT03875001|Drug|BI 1358894|tablet
15870865|NCT03875001|Drug|Placebo|tablet
15870866|NCT03874988|Behavioral|Portion-Controlled Meals|Participants will receive portion-controlled meals with the aim of encouraging weight loss and healthier eating.
15870867|NCT03874988|Behavioral|Enhanced Self-Monitoring|Participants will be encouraged to track their physical activity, food intake, and weight using technology that will be provided as part of the study.
15870868|NCT03874988|Behavioral|GLB-SCI|Participants will take part in a lifestyle intervention program (tailored for spinal cord injury needs) that encourages steady weight loss through increased physical activity and healthier diet patterns.
15870869|NCT03874988|Behavioral|GLB-SCI+|Participants will receive a combination of the prior interventions studied, with the goal of showing that a multi-component intervention will be the most effective in encouraging weight loss among participants with a spinal cord injury.
15870870|NCT03874975|Drug|oral vitamin D|vitamin D and UVB versus UVB alone in psoriatic patients and evaluate patients by PASI score before and after treatment and measure serum vitamin D before and after treatment
15870871|NCT03874962|Other|Routine oral cleaning and professional oral care group|Besides routine oral cleaning was conducted by caregivers, professional oral care intervention was conducted by dental hygienists, and it included muscle massage, oral cleaning, and oral health education once a week.
15870872|NCT03874949|Device|SEALITE Regular|Patients are treated with SEALITE Regular sealer (zinc oxide eugenol sealer). The SEALITE Regular powder is mixed with SEALITE Liquid according to the manufacturer instructions and added to gutta percha in the root canal for permanent obturation. The apical obturation is assessed by a postoperative radiographic control.
15870873|NCT03874949|Device|SEALITE Ultra|"Patients are treated with SEALITE Ultra sealer (zinc oxide eugenol sealer containing 1% Enoxolone).
~The SEALITE Ultra powder is mixed with SEALITE Liquid according to the manufacturer instructions and added to gutta percha in the root canal for permanent obturation. The apical obturation is assessed by a postoperative radiographic control."
15870874|NCT03874936|Drug|Dexamethasone 24mg Solution for Injection|Administrated i.v.
15870875|NCT03874936|Drug|Saline Solution for Injection|administrated i.v.
15870876|NCT03874923|Other|Fluid challenge|After randomisation, patient will receive 250 ml or 500 ml of fluid challenge. VO2 will be assessed before fluid challenge, immediately, 30 minutes and 60 minutes after fluid challenge.
15870877|NCT03874897|Drug|CAR-CLDN18.2 T-Cells|"Preconditioning with fludarabine, cyclophosphamide, based chemotherapy regimen at sub-clinical doses
~• Chimeric Antigen Receptor T Cells Targeting Claudin18.2"
15870878|NCT03874884|Drug|Olaparib|During dose escalation doses of olaparib that can be administered are 50mg BD, 100mg BD, 150mg BD,200mg BD,250mg BD or 300mg BD. The recommended phase 2 dose of olaparib will be used during dose expansion. Olaparib will be given on days 2-15 of each 42 day cycle for upto 4 cycles.
15870879|NCT03874884|Combination Product|177Lu-PSMA|A fixed 7.4Gbq administered activity of 177Lu-PSMA will be given 6 weekly.
15870880|NCT03874871|Procedure|Function preserving gastrectomy|Function preserving gastrectomy include pylorus preserving gastrectomy, proximal gastrectomy, and partial gastrectomy.
15870881|NCT03874871|Procedure|Standard gastrectomy|Standard gastrectomy include distal gastrectomy and total gastrectomy with standard lymphadenectomy according to the Japanese gastric cancer treatment guideline.
15870882|NCT03874858|Drug|Nilotinib|Nilotinib oral 300 mg QD hard capsules
15870883|NCT03874845|Behavioral|Mindfulness-Based Cognitive Therapy|Participants will attend 8 weekly group therapy sessions. Prior to and after therapy participants will have assessments related to their PTSD, fill out surveys, and have an fMRI.
15870884|NCT03874845|Behavioral|Muscle Relaxation Therapy|Participants will attend 8 weekly group therapy sessions. Prior to and after therapy participants will have assessments related to their PTSD, fill out surveys, and have an fMRI.
15870885|NCT03874832|Drug|Dihydroergotamine|Dihydroergotamine is a semi-synthetic derivative of ergotamine tartrate.
15870886|NCT03874819|Device|Medium cut-off dialyzer|Treatment using a Medium Cut-Off Dialyzer
15870887|NCT03874819|Device|High-flux dialyzer|Treatment using a high-flux dialyzer
15870888|NCT03874806|Drug|Ropivacaine 0.25%-NaCl 0.9% Injectable Solution|0.25% ropivacaine administered through a nerve catheter
15870889|NCT03874806|Drug|Ropivacaine 0.2%-NaCl 0.9% Injectable Solution|0.2% ropivacaine administered through a nerve catheter
15870890|NCT03874793|Behavioral|Mindfulness-Based Cognitive Therapy|Participants will attend 8 weekly group therapy sessions. Prior to and after therapy participants will have assessments related to their PTSD, fill out surveys, and have an fMRI.
15870891|NCT03874793|Behavioral|Muscle Relaxation Therapy|Participants will attend 8 weekly group therapy sessions. Prior to and after therapy participants will have assessments related to their PTSD, fill out surveys, and have an fMRI.
15870892|NCT03874780|Device|Vibe Delivery system|delivery of Botox (TM) to the bladder wall using an ultrasound technology with the Vibe delivery system
15870893|NCT03874767|Behavioral|Patient Mobility|A team of two mobility technicians will switch between two units on a monthly basis. The unit staffed by the mobility technician will be referred to as the intervention unit, while the other will be referred to as the control unit. One unit will start as the control unit and will switch to being the intervention unit after one month. Similarly, the other unit will start as the intervention unit and will switch to becoming the control unit after one month. All patients present on a unit during the intervention period will be provided mobility technician support according to standardized clinical guidelines that have been developed by the care team and described below. Patients who are present on a unit at the time of cross-over will not be included in the analysis, but will either no longer receive mobility technician support (if crossing from intervention to control) or will start to receive mobility technician support (if switching from control to intervention).
15870894|NCT03874754|Other|Tailored Technology-Enhance Home-based exercise program (iHBE)|The tailored technology enhanced home-based exercise (iHBE) program is a 4-week program with 1 assessment home visit session, 4 home visits during exercise. The detail activities are presented in table 1. The technologies, a wearable device, and a smartphone application, will be used as a tool to monitor physical performance (heart rate [HR], step count), provide immediate feedback, send daily reminding message through Mobile Ecological Momentary Assessment (mEMA). The coded raw data without personal identification information from the wearable device will be sent to the servers where the investigators can store it in the database alongside the mEMA data and create custom reports showing Heart Rate (HR) 30 minute before each Ecological Momentary Assessment (EMA) survey, showing HR and previous self-report responses before/ after each automatically triggered EMA.
15870895|NCT03874741|Drug|SCT200|"Anti-EGFR monoclonal antibody DDP(75mg/m2),d1; 5-FU(750mg/m2),d1-5, every 21d; PF chemothrapy up to 6 cycles. 6.0mg/kg of SCT200 will be administered once a week for a maximum of 6 cycles. After 6 cycles, 8.0mg/kg of SCT200 will be administered every two weeks until disease progression
~Other Names:
~• SCT200"
15870896|NCT03874728|Other|Minimal shoes|A minimal shoe (Vivobarefoot Ltd., London, UK) will be used.
15870897|NCT03874728|Other|Standardised conventional shoes|The Go Walk 4.0-Pursuit shoe for women (Skechers USA, Inc.) and the Superior 2.0-Jeveno shoe for men (Skechers USA, Inc) will be used.
15870898|NCT03874728|Other|Barefoot|Participants will conduct the assessments barefoot.
15870899|NCT03874728|Other|"Smart shoe insoles"|Arion pressure-measuring insoles (Eindhoven, The Netherlands) will be used in the study.
15870900|NCT03874715|Drug|Insulin Aspart SAR341402|Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
15870901|NCT03874715|Drug|Insulin Aspart|Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
15870902|NCT03874715|Drug|Insulin glargine U100|Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
15870903|NCT03874676|Other|PEACE Rounds|PEACE Rounds are a routine process for providing self help to clinicians who care for difficult patients from the perspective of ethics and the need for cross-disciplinary communication. PEACE Rounds participants will be interviewed about how they experience the rounds and for their perspective on the effects on their own wellness and resilience.
15870904|NCT03874663|Device|Directly assisted oral HIV self-testing (HIVST)|"To determine the ability of participants with unknown HIV status to correctly perform oral HIVST;
~To compare the results of the oral HIVST with confirmatory rapid finger prick HIV test.
~To explore participants attitudes and preferences towards oral HIVST.
~To explore the feasibility, acceptability and appropriateness of using a mobile photo verification app to verify HIV self-testing results."
15870905|NCT03874650|Behavioral|Activity Planning Group|Participants in this group will receive 8 1-hour sessions of Behavioural Activation combined with select Goal Management Training strategies over the course of 8 weeks.
15870906|NCT03874650|Behavioral|Activity Engagement Group|Participants in this group will attend 8 1-hour sessions of various social activities such as board games and puzzles.
15870907|NCT03874650|Behavioral|Waitlist Group|Participants in this group will continue on their care as usual before being re-randomised into either the Activity Planning Group or Activity Engagement Group after 8 weeks.
15870908|NCT03874637|Device|Treament|Placement of the FemPulse System with therapy delivery
15870909|NCT03874637|Device|Sham Control|Placement of the FemPulse System without therapy delivery
15870910|NCT03874624|Diagnostic Test|two-dimensional speckle tracking|Analysis of myocardial left atrial strain using two-dimensional speckle tracking echocardiography.
15870911|NCT03874611|Other|electrophysiological data from DBS|For each selected patient, the evaluation of cognitive or sensory-motor functions by electrophysiology will be conducted in the operating room, preoperatively the week before implantation and post-operatively within five days between the implantation of deep electrodes and the setting of the stimulator.
15870912|NCT03874598|Procedure|Ear acupuncture|Patients in the intervention group are treated twice a week for five weeks using semi-standardized ear acupuncture.
15870913|NCT03874598|Behavioral|Psychoeducation|Patients of the control group receive a 1,5 h psychoeducation group concerning sleep improving behaviour.
15870914|NCT03874585|Behavioral|Group counseling and nicotine replacement|Participants will receive a 30-minute group smoking cessation counseling session and a supply of nicotine replacement.
15870915|NCT03874585|Behavioral|Group counseling, nicotine replacement, and text messaging support|Participants will receive a 30-minute group smoking cessation counseling session, a supply of nicotine replacement, and the 6-week text messaging intervention to provide ongoing support for quitting
15870916|NCT03874572|Biological|Allogeneic adipose derived stem/stromal cells|Culture expanded allogeneic adipose derived stem/stromal cells
15870917|NCT03874559|Diagnostic Test|Blood Draw|Serum samples will be obtained from each patient enrolled
15870918|NCT03874546|Other|Questionnaire|"Two clinicians will complete a questionnaire that analyses their perception of the patient's prognosis at Day1 and Day7.
~At 6 months, another clinician will establish the patient prognosis using Glasgow Outcome Scale and Glasgow outcome scale extended. This clinician must not know the patient's IMPACT score and prognosis established at Day 1 and Day 7. His evaluation will be compare to the patient's prognosis established previously (Day1 and Day7)."
15870919|NCT03874533|Device|Self-adjustment tests|"For patients with an implant Cochlear™, we will be trained during workshop, to use a tablet how to do some tests ; They will do alone, by themselves the tests, just after the workshop and 8 to 30 days later.
~Self audiometric test : digit triplet test, consonants discrimination test, Self-fitting of cochlear implant"
15870920|NCT03874520|Other|Video triage|The operator will offer the parent calling regarding the sick child to assess the child on video, as compared to the current standard; on the telephone.
15870921|NCT03874507|Other|Virtual Reality/Augmented Reality Headset|"A virtual reality (VR) headset is a device the participant will wear over his/her head and eyes like a pair of goggles. It blocks out all external light and shows him/her an image on high-definition screens in front of his/hers eyes. It implies a complete immersion experience that shuts out the physical world.
~Augmented reality (AR) headset is a device that the participant will wear over his/hers head and eyes and it adds digital elements to a live view."
15870922|NCT03874494|Drug|Brexpiprazole|Brexpiprazole 2-4 mg/day
15870923|NCT03874494|Drug|Aripiprazole|Aripiprazole 10-20 mg/day
15870924|NCT03874481|Other|Observation|follow up regularly for MACE
15870925|NCT03874468|Device|X-ray|standing anteroposterior radiographs of the full-length lower limb with patients in the standing position. ( HKA Long Film Radiographs ).
15870926|NCT03874455|Drug|Tazemetostat|Tazemetostat (EPZ-6438) is a selective small molecule inhibitor of the histone-lysine methyltransferase EZH2 gene
15870927|NCT03874442|Other|CliniPup serious game|"The interactive game is played at home by the children on a computer or tablet before the surgery. The SERES Pain in Children-game is created with realistic scenarios based on scientific literature about perioperative pain and fear in children. The primary goal of the game is to provide the children insight in the impact of their personal choices on their well-being and on their environment by giving the children information about the day of the surgery. The ultimate aim of the game is to create a change in behaviour, enhance children's coping strategies and reduce the burden of pain and fear in the children and parents."
15870928|NCT03874429|Device|T2259|HA and Trealose
15870929|NCT03874429|Device|Vismed multi|HA
15870930|NCT03874416|Other|Specific rehabilitation|"Experimental rehabilitation of working memory:
~3 sessions per week during 3 months, for a total 36 sessions."
15870931|NCT03874416|Other|Non-specific rehabilitation|Usual non-specific rehabilitation treatment for moderate to severe TBI in healthcare facilities: 2-3 sessions per week for 3 months.
15870932|NCT03874403|Procedure|DSA|The changes on DSA on NIVATS and VATS
15870933|NCT03874390|Other|ozone|gaseous ozone was applied on periodontal pocket two times in one week.
15870934|NCT03874377|Behavioral|Mindfulness|Mindfulness refers to the experience of paying attention to the present moment in a nonjudgmental manner. The mindfulness intervention consists of 6 weekly sessions focused on: experiential mindfulness exercises, such as mindful eating, loving kindness practices, breath awareness, and mindful movement; hunger and satiety awareness; improving responses to emotions; practicing acceptance and being non-judgmental; and tolerating negative feelings and sensations, including those related to hunger and cravings. Participants will be assigned brief homework exercises (approximately 10 minutes) daily in between appointments.
15870935|NCT03874377|Behavioral|Usual Care|Participants will receive the recommended standard of medical management of overweight and obesity. The clinic team conducts a comprehensive evaluation of the patient to assess dietary and activity behavior change needs of each patient and family, as well as obesity-associated comorbidities. In addition to management of comorbidities, goals for improved physical activity and dietary behaviors are set with the patient and family at each visit.
15870936|NCT03874364|Device|Lidocaine gel|10 ml 2% lidocaine gel is instilled with a syringe through the length of the urethra and kept in site at least 5 minutes prior the introduction of the cystoscope.
15870937|NCT03874364|Other|Counselling|Patients receive a brochure in the waiting room explaining the procedure in details.
15870938|NCT03874364|Other|Monitor|Patients are allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.
15870939|NCT03874364|Device|Lubricating gel|10 ml plain lubrificant gel is instilled with a syringe through the length of the urethra and kept in site at least 5 minutes prior the introduction of the cystoscope.
15870940|NCT03874364|Other|No counselling|Patients won't receive a brochure in the waiting room explaining the procedure in details.
15870941|NCT03874364|Other|No monitor|Patients are not allowed to view and follow the procedure on a monitor connected to the cystoscope's camera.
15870942|NCT03874351|Device|non-invasive transcranial direct current stimulation (tDCS)|Non-invasive remotely supervised transcranial direct current stimulation at intensity 1.5mA or sham applied by participants at home for 20 minutes per day on 60 consecutive days, over the area of the dorsolateral prefrontal cortex, using sponge saline-premoisturized electrodes of size 5x5cm, the anode on the left, the cathode on the right.
15870943|NCT03874338|Drug|Colchicine Pill|Participants in the main CLEAR SYNERGY trial are randomized to colchicine/spironolactone versus placebo in a 2x2 factorial design. The substudy is interested in the evaluation of biospecimens obtained from patients in the colchicine vs placebo group.
15870944|NCT03874325|Drug|Durvalumab|1500 mg Durvalumab will be administered intravenously every 4 weeks for 6 months.
15870945|NCT03874325|Drug|Anastrozole 1mg|Participants will self administer 1 mg anastrozole by mouth daily for 6 months.
15870946|NCT03874325|Drug|Letrozole 2.5mg|Participants intolerant to anastrozole will self administer 2.5 mg letrozole by mouth daily for 6 months. Exemestane may be substituted.
15870947|NCT03874325|Drug|Exemestane 25 MG|Participants intolerant to anastrozole will self administer 25 mg exemestane by mouth daily for 6 months. Letrozole may be substituted.
15870948|NCT03874312|Diagnostic Test|Linear ultrasound (US) assessment of the internal jugular vein|Evaluation of jugular vein distensibility at rest and after Valsalva maneuver by US at the time of the RHC. US-guided IJV is routinely performed at the time of vein cannulation.
15870949|NCT03874286|Diagnostic Test|Liver Transplant|Patients will obtain a research blood draw and a liver biopsy at 4 months and 12 months post transplant. Liver biopsies are routinely performed in the liver transplant population. We will be obtaining a liver biopsy at this particular time point to compare the biopsy results with the peripheral blood results.
15870950|NCT03874273|Drug|Crizotinib|Crizotinib 280mg/m2 twice a day (for 24 months maximum)
15870951|NCT03874260|Drug|Fenofibrate|statin(rosuvastatin 10mg or atorvastatin 10mg or atorvastatin 20mg) + choline fenofibrate vs statin(rosuvastatin 10mg or atorvastatin 10mg or atorvastatin 20mg) + choline fenofibrate placebo / once a day, P.O
15870952|NCT03874247|Drug|pelubiprofen 45mg|bid for 3 days after meal
15870953|NCT03874247|Drug|pelubiprofen placebo|bid for 3 days after meal
15870954|NCT03874234|Drug|GSK3186899|GSK3186899 will be available as white to slightly colored, spray dried powder in a bottle to be administered orally along with mixture of propylene glycol and water.
15870955|NCT03874234|Drug|Placebo|Placebo will be available as white to slightly colored, blend powder in a bottle to be administered orally along with mixture of propylene glycol and water.
15870956|NCT03874208|Other|MRI sequence|An additional sequence to conventional MRI exam (Diffusion tensor imaging) lasting less than 10 min (depending on the MR scanner type and sequence used).
15870957|NCT03874208|Other|MRI|MRI exam
15870958|NCT03874195|Behavioral|Access to PCforMe for review|Intervention Arm subjects will receive access to PCforMe.
15870959|NCT03874195|Behavioral|Access to three nationally-recognized Palliative Care websites for review|Subjects in the Active Control arm will receive a list of three nationally-recognized websites to receive information on palliative care
15870960|NCT03874169|Device|E4 wristband|A biosensor watch that monitors the patient's heartbeat, heart rate variability, skin conductance, and temperature in order to discover if they are having a GI bleed
15870961|NCT03874156|Drug|Atorvastatin 40mg|Oral tablet fabricated and labelled at Krageroe Tablettproduksjon AS
15870962|NCT03874156|Drug|Placebo Oral Tablet|Oral tablet fabricated and labelled at KrageroeTablettproduksjon AS
15870963|NCT03874143|Other|mHealth Intervention for Quality of Care|Does use of a specially equipped smartphone make a difference in the diagnosis and treatment by RCom of malaria, pneumonia and diarrhea in children aged 2 to 59 months
15870964|NCT03874130|Drug|Scopolamine|IV Scopolamine
15870965|NCT03874117|Other|Twice weekly hemodialysis|Effect of hemodialysis prescriptions of twice weekly versus thrice weekly on quality of life will be evaluated. All hemodialysis will be prescribed to achieve adequate treatment based on current National Kidney Foundation guidelines.
15870966|NCT03874117|Other|Thrice weekly hemodialysis|Effect of hemodialysis prescriptions of twice weekly versus thrice weekly on quality of life will be evaluated. All hemodialysis will be prescribed to achieve adequate treatment based on current National Kidney Foundation guidelines.
15870967|NCT03874104|Dietary Supplement|Extensively Hydrolysed Formula containing Pre- & Probiotics|Extensively Hydrolysed Formula containing Pre- and Probiotics
15870968|NCT03874091|Procedure|bilateral ESP block with 0,25% Bupivacaine+ Adrenaline|Regional anaesthesia technique performed under ultrasound guidance before surgery
15870969|NCT03874091|Procedure|ESP block continuous infusion with 0,125% Bupivacaine+Adrenaline|Continous infusion of Local Anaesthetic (LA) given postoperatively via the catheter.
15870970|NCT03874091|Drug|Morphine PCA pump|Morphine given postoperatively.
15870971|NCT03874065|Other|Medical Chart Review|Collection of data from participant's medical chart
15870972|NCT03874052|Drug|Ruxolitinib|Given PO
15870973|NCT03874052|Drug|Venetoclax|Given PO
15870974|NCT03874039|Device|Gas sensor|The gas sensor is an airtight gas capsule attached with a floating solid phase microextraction (SPME) tube. SPME uses a fiber coated with a nontoxic liquid (polymer), and a nontoxic solid (sorbent). The fiber coating extracts the compounds from the gas being released from the skin. Only the glass sample is in contact with the skin.
15870975|NCT03874039|Device|Sweat Sensor|The sweat sensor is a soft, flexible device that rests on the skin and collects secreted sweat through capillary action. The device is held in place by medical-grade acrylic adhesive film.
15870976|NCT03874026|Drug|Folfiri/Cetuximab|"Cetuximab 400 mg/mq intravenously (iv) with load dose of 400 mg/mq at the first cycle followed by 250 mg/mq iv weekly by iv infusion in 90 minutes. The administration of irinotecan will precede that of cetuximab and will consist on a dose of 180 mg/mq iv in 60 minutes every two weeks and it will be followed by fluorouracil (5-FU) at a dose of 400 mg/mq in slow iv bolus at half of lederfolin 200 mg/mq 2-hours infusion. At the end of the infusion of lederfolin an elastomeric pump loaded with 5-FU 2400 mg/mq in continuous 46 hours iv infusion will be applied. Only at the first administration of CT (load dose of cetuximab), irinotecan will not be administered."
15870977|NCT03874013|Drug|MOD-4023|"MOD-4023 is a long-acting modified recombinant human growth hormone (r-hGH) which utilizes C-terminal peptide (CTP) technology. It will be provided as a solution for injection containing 20 or 50 mg/mL MOD-4023 in a multi-dose disposable pre-filled PEN.
~MOD-4023 will be administered as a SC injection once weekly, using a delivery device."
15870978|NCT03874013|Drug|Genotropin|"Genotropin® is dispensed in a 2-chamber cartridge. The front compartment contains recombinant somatropin, glycine, mannitol, sodium dihydrogen phosphate anhydrous and disodium phosphate anhydrous. The rear compartment contains m-Cresol and mannitol in water for injections.
~A delivery device (Genotropin®) will be used for daily (evening/bedtime) SC administration of Genotropin® into the region of the upper arms, buttocks, thighs or abdomen (8 locations). Injection sites should be rotated.
~Dose regimen for Genotropin®: 0.025 mg/kg/day (or 0.175 mg/kg/w divided equally to 7 injections over a week)."
15870979|NCT03874000|Biological|Sintilimab|Given IV
15870980|NCT03874000|Drug|Metformin Hydrochloride|Given PO
15870981|NCT03873987|Drug|Current Formulation of Oritavancin|Current formulation of oritavancin (3 hour infusion of 1200 mg in 1000 ml of D5W)
15870982|NCT03873987|Drug|Kimyrsa|New formulation of oritavancin (1 hour infusion of 1200 mg in 250 ml of saline)
15870983|NCT03873974|Diagnostic Test|DualDur dark-field microscopic test|Morphologically identify the presence of Borrelia burgdorferi sensu lato bacteria (in a broader sense) which are present in the body fluid, hence to verify Borreliosis. Manual evaluation.
15870984|NCT03873974|Diagnostic Test|DualDur dark-field automatic microscopic test|Morphologically identify the presence of Borrelia burgdorferi sensu lato bacteria (in a broader sense) which are present in the body fluid, hence to verify Borreliosis. Software evaluation.
15870985|NCT03873974|Diagnostic Test|Western blot IgM and IgG|Borrelia qualitative in vitro test in order to detect and reliably identify IgG and IgM antibodies against Borrelia burgdorferi from human serum or plasma.
15870986|NCT03873974|Diagnostic Test|Bózsik Western blot IgM and IgG|Borrelia qualitative in vitro test in order to detect and reliably identify IgG and IgM antibodies against Borrelia burgdorferi from human serum or plasma.
15870987|NCT03873974|Diagnostic Test|enzyme-linked immunosorbent assay (ELISA) IgM and IgG|Standard ELISA test for Lyme borreliosis.
15870988|NCT03873974|Diagnostic Test|DualDur Polymerase chain reaction|DualDur PCR test for Lyme borreliosis.
15870989|NCT03873961|Device|High-intensity laser therapy|tissue photobiostimulation for pain reduction and healing enhancement.
15870991|NCT03873948|Other|Evaluation of arginine serum level|correlation of serum arginine level with periodontal and cardiovascular disease
15870992|NCT03873935|Other|Evaluation of periodontal status|Clinical examination
15870993|NCT03873922|Other|Ketogenic diet intervention|Ketogenic, really low carbohydrate containing (15-20 g/day), meals will be offered to the participants.
15870994|NCT03873909|Other|Fruit Smoothie|Fruit Smoothie with 150-200 g mamey sapote fruit
15870995|NCT03873909|Other|Matrix-Free Shake|Shake containing mamey sapote extracted carotenoids (2 g, 845 µg sapotexanthin and 1.21-1.51 mg cryptocapsin
15870996|NCT03873896|Diagnostic Test|Stimulated skin wrinkling test|Stimulated skin wrinkling induced by the application of EMLA (eutectic mixture of local anesthetic) cream to the finger pads of blocked and unblocked fingers of study volunteers (test applied to both study arms)
15870997|NCT03873896|Procedure|Digital Nerve Block|A digital nerve block is performed by injecting a total of 3 millilitres of 2% Lidocaine at the base of the ring finger of randomized hand of the volunteer. The effect of the block is confirmed clinically before proceeding with the study data collection. Please see the description for more details on the procedure
15870998|NCT03873883|Drug|EOS100850|Oral administration
15870999|NCT03873883|Drug|Pembrolizumab|IV Infusion
15871000|NCT03873883|Drug|Chemotherapy|Standard of Care
15871001|NCT03873870|Diagnostic Test|68Ga -DOTATATE PET scans|PET scan using 68Ga-DOTATATE contrast
15871002|NCT03873857|Drug|Venetoclax|tablet;oral
15871003|NCT03873844|Behavioral|Speed of Processing Training|"Speed of Processing Training (SOPT). Speed of processing training involves trainer-guided practice of computer-based video games. The games require the player to identify targets that are presented very briefly. SOPT has the primary aim of improving the fluid ability of mental processing speed such that trainees can process increasingly more information and increasingly more complex information over briefer periods of time. The training primarily involves practice with feedback. Trainers also offer suggestions, encouragement, and personalized modifications of difficulty for the trainee according to a specified protocol. At a display speed and task difficulty level tailored to their ability, trainees practice blocks of 16 trials. Trainees receive immediate feedback after each trial and see their total correct trials at the end of each block of trials. Trainers tell the trainees that their goal is to achieve performance of 10 to 12 correct trials for each training block."
15871004|NCT03873844|Behavioral|Transfer Package from CI Therapy|Behavioral Contract. At the outset of treatment, the therapist negotiates a contract with the participant and caregiver, if one is available.Daily home diary. During treatment, the participants catalog the ADL and IADL for the part of the day spent outside the laboratory. Daily administration of the Cognitive Task Activity Log (CTAL). The CTAL collects information about attempts by the participant to complete ADL and IADL. Problem Solving. The therapist helps participants to think through any barriers to completing ADL and IADL independently. Home skill assignments during treatment. Participants are assigned on a written check-off sheet 10 specific ADL tasks. Home skill assignments after treatment. Toward the end of treatment, a written individualized post-treatment program is developed containing a list of up to 10 IADL for each day of the week. Post-treatment telephone contacts. Participants are contacted during the 12 month period after treatment to evaluate treatment outcomes.
15871005|NCT03873831|Behavioral|Animal-assisted intervention|The therapy dog is present during the session.
15871006|NCT03873831|Behavioral|Social skills group|"The group program is 10 weeks in duration, with 1-hour long sessions once per week. Children will be taught new social skills each week using an established teaching interaction procedure, in which the therapist first describes the target skill, provides a rational and context for the behavior, divides the skill into smaller steps, demonstrates the behavior, and has each learner role-play the skill while providing feedback in the form of praise and tokens and corrective instruction. The last week involves a probe free-play session, in which children are assessed in a more naturalistic environment without any corrective feedback from therapists."
15871007|NCT03873818|Biological|Ipilimumab|Given IV
15871008|NCT03873818|Biological|Pembrolizumab|Given IV
15871009|NCT03873805|Biological|Autologous Anti-PSCA-CAR-4-1BB/TCRzeta-CD19t-expressing T-lymphocytes|Given IV
15871010|NCT03873805|Drug|Cyclophosphamide|Given IV
15871011|NCT03873805|Drug|Fludarabine|Given IV
15871012|NCT03873805|Drug|Fludarabine Phosphate|Given IV
15871013|NCT03873792|Diagnostic Test|Physician diagnoses a history of asthma or eczema or allergic rhinitis or health pregnant women|Physician diagnoses a history of asthma or eczema or allergic rhinitis
15871014|NCT03873779|Device|The ZELTIQ System|The CoolSculpting machine will be used to perform the treatments.
15871015|NCT03873766|Drug|Intrapleural Medications|The IPFT group will receive a total of 5-6 doses of alteplase 10mg and DNase 5 mg twice daily x 3 days. delivered through a chest tube or small bore catheter into the pleural space. The doses will be given twice a day. If the first IPFT dose is given in the evening on the first day, they will only receive a total of 5 doses of the dual-agent IPFT (alteplase and DNase).
15871016|NCT03873766|Procedure|Surgery|The surgical arm will have either open surgery or a Video assisted Thoracoscopic Surgery (VATS) approach at the discretion of the surgeon
15871017|NCT03873766|Procedure|Pleural Sampling|Pleural fluid may be sampled by the responsible clinical service in the course of clinical care for patients with suspected pulmonary infection or by consulting service after identification of patient. Some patients will have a thoracentesis or tube drainage, and others will have no intervention at the time of referral for study eligibility review. Enrollment reflects real world clinical care and patients will be considered for enrollment regardless of sampling techniques or timing prior to evaluation
15871018|NCT03873766|Procedure|Pleural fluid drainage|All patients in the study must have tube thoracostomy for drainage of the pleural space. This may have been done by the clinically responsible team or by the study team. Physicians may select chest tubes of any type, but the minimum size is 14 French. For patency, chest tubes 14-20 French should be kept at negative 20 suction and flushed daily. Large bore chest tubes (>20French) may be kept at negative 20 suction at the discretion of the physician managing the chest tube and do not require daily flushing. Supportive care will follow Institutional Guidelines.
15871067|NCT03873363|Device|CR TKA|Implantation of a cruciate retaining Total Knee Arthroplasty.
15871068|NCT03873350|Other|Consumption of kombucha|The intervention performed in the study implies letting healthy individuals consume one bottle (33 cl) of living kombucha daily for three weeks.
15871019|NCT03873766|Radiation|Protocol Image #1|"Once the chest tube is placed, imaging is obtained within 24-48 hours to assess the fluid drainage. The choice of image, either Chest X-ray or CT Chest, is up to the discretion of the treating physician. Based on the imaging, patients will be separated into 2 groups:
~A: Complete drainage/re-expansion of the lung: If there is complete drainage of the pleural fluid collection and lung re-expansion based on image #1, patients will follow usual clinical care without randomization and be observed until discharge. Patients will remain in the study and their data will be collected.
~B: Incomplete drainage/incomplete lung re-expansion: For those patients that have incomplete drainage of the pleural fluid collection on image #1 and/or the lung does not re-expand."
15871020|NCT03873766|Other|Surgical Consultation|A thoracic surgery consultation will be obtained on all patients with incomplete drainage and/or the lung does not re-expand, to determine surgical candidacy. Those patients that the surgical team deem unsafe for surgery will receive clinically appropriate guideline centered, non-surgical, care. These patients will not be randomized but they will remain in the study and their data will be collected. Criteria deeming patients unfit for surgery include, but are not limited to: inability to tolerate single lung ventilation, severe chronic obstructive pulmonary disease (COPD), and risk of surgery prohibitive. Patients not excluded from surgery will be randomized.
15871021|NCT03873766|Radiation|Protocol Image #2: Chest X-ray PA/Lateral|The morning after intervention completion (surgery or last dose of IPFT), a chest X-ray PA/lateral will be obtained (protocol image #2). Based on Image #2 the patient will be categorized into one of three groups: satisfactory improvement of pleural fluid collection, unsatisfactory improvement in pleural fluid collection on imaging, or treatment failures.
15871022|NCT03873766|Behavioral|Quality of Life|Quality of life will be measured at 30 day and 90 day and 1 year clinical follow-up using the SF-36 quality of life survey and return to work questionnaires
15871023|NCT03873753|Other|Cleaning|Gauze and mineral water
15871024|NCT03873753|Other|No oral cleaning|Absence of cleaning
15871025|NCT03873740|Biological|EV71 inactived vaccine（Vero cells）|The EV71 inactived vaccine（Vero cells） was manufactured by Sinovac Biotech Co., Ltd.
15871026|NCT03873740|Biological|EV71 inactived vaccine（Human diploid cells）|The EV71 inactived vaccine（Human diploid cells） was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.
15871027|NCT03873727|Biological|Prevenar13 (PCV13) and Pneumovax (PPS23)|One dose of PCV13 at Month 0 and one dose of PPS23 at Month 12
15871028|NCT03873727|Biological|Placebo / Pneumovax (PPS23)|One dose of Placebo at Month 0 and one dose of PPS23 at Month 12
15871029|NCT03873727|Biological|Blood sample|an additional 5 mL sample of blood at one of the visits, preferably at the first visit, concerning patients included in Parisian centers who did not participate in SPLENEVAC 1 study.
15871030|NCT03873714|Device|Pipeline™ Vantage Embolization Device with Shield Technology™|Pipeline™ Vantage Embolization Device with Shield Technology™
15871031|NCT03873701|Diagnostic Test|bedside ultrasonography|Patients suspicious to urinary tract infection with kidney involvement are being examined by ultrasonography to detect hydroneprhosis. The treating clinicians fill out questionnaires to validate the impact of the bedside ultrasonography on the patient care and treatment.
15871032|NCT03873688|Other|expiratory muscle training|The intensity of training will been determined after assessment of maximal expiratory pressure (MEP). The first training session will perform under the supervision of a physiotherapist, patients will perform training at home. MEP measurement will reevaluate every two weeks and the intensity of training will set according to MEP levels.
15871033|NCT03873675|Diagnostic Test|parathyroid hormone|10-20ml blood samples taken from the arterial catheter every 12 hours to obtain parathyroid hormone serum concentration. 6-8 samples per patient
15871034|NCT03873662|Diagnostic Test|Blood sample|Biochemical markers will be recorded as follows: as soon as possible after the arrival of the patient and insertion of a intravenous line, blood will be drawn for the analysis of arterial blood gases, which are a standard test in patients admitted to emergency department. Blood will be analysed in a bed-side analyzer. Serum lactate and base-excess (BE) will be documented from this blood sample. Another blood sample will be drawn parallelly for biochemical tests which will be sent to the laboratory. These tests standard in patients admitted to emergency department. Serum concentration of NSE and S100B protein will be analysed and recorded from this sample. A sample of blood for the evaluation of the early dynamics of the serum concentration of NSE and S100B will be redrawn after 12 and 48/24 hours after admitting the patient.
15871035|NCT03873649|Other|Bronchoscopy with lavage|"Bronchoscopy will be performed according to standard clinical procedures. Bronchoscopy will be performed under conscious sedation with continuous cardiopulmonary monitoring and the subject's upper airway will be anesthetized with topical lidocaine. The bronchoscope will be passed through the naris or mouth to the upper airway and then into the lower airway. 360cc of sterile saline will be instilled into 2 sub-segments by instilling and aspirating 3 aliquots of 60cc sequentially into each sub-segment.
~Venipuncture to obtain peripheral blood mononuclear cells (PBMCs) for the proposed assays.
~Cells collected will be analyzed for various T-cell subsets and gene expression to help determine the type of immune response."
15871036|NCT03873636|Other|Stimulation via noninvasive brain stimulation systems|Active (at or below 2mA) stimulation targeting brain regions engaged in task-switching and dual-tasking for 30-40 minutes. Local IRB has determined the Soterix, Neuroelectrics, & Halo devices to be non-significant risk (NSR) devices via abbreviated investigational device exemption (IDE) procedure.
15871037|NCT03873610|Behavioral|Stress and Symptom Management Program 1|The Stress and Symptom Management Program 1 introduces and reinforces stress and symptom management for adolescents with NF. The program consists of 8 weekly 45 minute sessions, delivered through videoconferencing.
15871038|NCT03873610|Behavioral|Stress and Symptom Management Program 2|The Stress and Symptom Management Program 2 introduces and reinforces stress and symptom management for adolescents with NF. The program consists of 8 weekly 45 minute sessions, delivered through videoconferencing.
15871069|NCT03873350|Other|Consumption of heat-sterilized kombucha|The intervention performed in the study implies letting healthy individuals consume one bottle (33 cl) of heat-sterilized kombucha daily for three weeks.
15871070|NCT03873337|Behavioral|Persistence Targeted Smoking Cessation in Schizophrenia|All participants will receive 8 weeks of smoking cessation counseling
15871071|NCT03873337|Behavioral|Clearing the Air|All participants will receive 8 weeks of smoking cessation counseling
15871072|NCT03873337|Drug|Nicotine patch|All participants will receive 10 weeks of nicotine patch
15871039|NCT03873597|Behavioral|Tele-coaching + Usual Care|The tele-coaching intervention will be delivered for 3 months following discharge from hospital. This consists of: 1) An interview discussing motivational issues, favourite daily activities and strategies to become more physically active; 2) a step counter 3) a smart phone with tele-coaching application providing activity goals (daily steps), feedback and educational tips on a daily basis. Patients' targets will be automatically revised on a weekly basis, based on performance in the preceding week; (4) a booklet containing home exercises; (5) weekly activity proposals; (6) tele-phone contacts triggered in the case of non-compliance, failure to transmit data or difficulty to progress.
15871040|NCT03873584|Other|Fatigue|Iron deficiency anemia with fatigue symptoms
15871041|NCT03873545|Procedure|Cryopreserved Osteochondral Allograft|This tissue is a laser-etched, cryopreserved fresh osteochondral allograft that was developed as a single-stage alternative for articular cartilage restoration.
15871042|NCT03873532|Drug|Surufatinib|Patients receive oral Surufatinib at a dose of 300mg/d within 1 hour after breakfast (once-daily dosing continuously, every 21-day treatment cycle).
15871043|NCT03873532|Drug|Capecitabine|Capecitabine is given at 1250 mg/m2 by oral administration twice a day (BID, one dose each in the morning and evening, with a total dose of 2500 mg/m2 per day) for 2 weeks followed by 1 week of drug interruption. Each course of treatment will last 3 weeks. Capecitabine tablets should be swallowed with water within 30 minutes after a meal.
15871044|NCT03873519|Other|Chromatic Environment|Rooms where chemotherapy sessions are delivered will be modified to show warm/cold color temperature in walls and equipment.
15871045|NCT03873519|Other|Room Orientation|Room will be facing North or South
15871046|NCT03873506|Drug|transplantation of hUC-MSCs|Human umbilical cord-derived mesenchymal stem cells had given to preterm infants through intravenous infusion.
15871047|NCT03873493|Drug|Venetoclax|tablet; oral
15871048|NCT03873493|Drug|Ibrutinib|capsule; oral
15871049|NCT03873480|Procedure|Administration of Marcaine without Epinephrine prior to the start of surgery|The intervention is the timing of administration of marcaine without epinephrine during a trigger thumb surgery.
15871050|NCT03873467|Behavioral|Group Lifestyle Balance|The Group Lifestyle Balance (GLB) program is a self-management intervention that has been shown to result in weight-loss and reduce the risk for Type 2 diabetes through increased physical activity and healthy eating behaviors in the general population. The GLB is a direct adaptation of the Diabetes Prevention Program, both developed at the Diabetes Prevention and Support Center at the University of Pittsburgh. The GLB is designed for delivery in a group-based, community setting, and has resulted in weight-loss in a variety of settings, such as community centers, churches, worksites, and healthcare systems. The GLB curriculum used in this study has been adapted for people with stroke.
15871051|NCT03873467|Other|Usual Care|Participants randomized to the wait-list control group will receive usual care for 6 months before beginning the modified GLB program.
15871052|NCT03873454|Device|Sennheiser non-occlusive headphones|Patients listened to music of their choice using non-occlusive headphones
15871053|NCT03873454|Device|Sennheiser non-occlusive headphones without music|Patients wore non-occlusive headphones but had no music playing
15871054|NCT03873454|Other|No Sennheiser non-occlusive headphones|Patients did not wear non-occlusive headphones and did not listen to music
15871055|NCT03873441|Other|Computer Games-Aided Balance Training Protocol|"1) Sitting Balance exercises while playing the interactive computer games starting with bi manual object placed in hands for controlling the games, then using the head rotation movements to control the games progressing to use of trunk motions to control games while balancing on the compliant surfaces in order to progress by increasing the balance costs.
~(2) Standing Balance exercises progressing from a fixed support surface to uneven, compliant surfaces like progression from standing over ground to sponge to air bladder as child tolerates increased balance costs.
~(3) Progression then to balancing while performing the visuomotor and visuospatial game tasks such as playing the games starting with bi-manual object placed in hands for controlling the games, then using the head rotation movements to control the games and then progressing to use of trunk motions to control games while balancing on compliant surface.
~(4) Progression to single-leg stance and stepping activities."
15871056|NCT03873441|Other|Conventional Balance Training Protocol|"The following is a summary of the conventional physical therapy balance training protocol:
~Active-assisted stretching exercises for lower limb musculature focusing on postural control and improvement in dynamic stability,
~Balance and weight bearing exercises with multi-directional reach outs associated with trunk movements on fixed surface gradually progressing to unstable movable and compliant surfaces,
~Weight transfer exercises with multi-directional reach outs and
~Stepping exercises in different directions on variety of surfaces."
15871057|NCT03873428|Other|FES PET|FES injection
15871058|NCT03873415|Drug|BMS-986165|Oral administration
15871062|NCT03873389|Drug|Ocrelizumab|Patients who are beginning this medication based on patient's treating physician's recommendation will be enrolled in the study.
15871063|NCT03873376|Behavioral|Opt-in; Receive offer to order self-sampling kit|Women in the opt-in arm receive an offer to order a HPV self-sampling kit, in addition to information about the study. Women who order, receive a kit that includes a self-sampling brush (Evalyn, Rovers Medical Devices), with instructions for use and a pre-paid envelope for returning the brush for HPV testing. The women are also informed that they can attend ordinary screening, i.e. performed by a physician. Women who choose self-sampling and test positive for high-risk HPV will be 1:1 allocated to follow-up by their general practitioner or a gynecologist. Women who test negative for high-risk HPV return to the ordinary screening program
15871064|NCT03873376|Behavioral|Opt-out; Receive self-sampling kit unsolicited|Women in the opt-out arm receive the self-sampling kit directly, without having ordered it themselves. The kit has the same contents, and the follow-up is the same, as that described for the opt-in arm.
15871065|NCT03873376|Behavioral|Control; Receive open reminder to be screened by physician|Similar to the procedure of the national screening program, women in the control arm receive a reminder to be screened by their general practitioner, and continues in the ordinary screening program
15871066|NCT03873363|Device|PS TKA|Implantation of a posterior stabilized (cruciate substituting) Total Knee Arthroplasty.
15871073|NCT03873324|Drug|CPL500036 compound|IMP is a capsule with CPL500036 as an Active Pharmaceutical Ingredient (API).
15871074|NCT03873324|Drug|Placebo|matching placebo capsules
15871075|NCT03873311|Drug|Azacytidine, HAG Regimen|Azacytidine（75mg/m2 QD for 7 days）+ HAG Regimen（Homoharringtonine(HHT) 1mg/(m2.d) for 14 days), Cytarabine 10mg/(m2.d) for 14 days, granulocyte colony-stimulating factor(G-CSF) 200ug/(m2.d) for 14 days until absolute neutrophil count(ANC) ≥ 10X109／L)
15871076|NCT03873311|Drug|Azacytidine|Azacytidine 75mg/m2 QD for 7 days.
15871077|NCT03873298|Drug|Inhaled nitric oxide|Inhaled nitric oxide delivered through a pulsatile nitric oxide drug delivery system
15871078|NCT03873285|Genetic|Genetic diagnostic by mendeliome or genome|For cases not explained by a mendeliomes: genome and transcriptome on fibroblast culture
15871079|NCT03873272|Device|Cryotherapy|Study subjects will wear NatraCure flexible socks on bilateral hands and feet. The sock will act as a mitten and covers the entire hand until past the wrist. There are 2 gel packs inserted into the sock, to provide cooling to the dorsal and frontal aspect of the hand. For the feet, the sock will cover the entire foot until above the ankle. Garments will be refrigerated for at least 3 hours at -25 to -30 Celsius prior to use. With each infusion, patients will wear the frozen garments on their hands and feet for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion. Two sets of socks will be used during each session for 45-60 minutes each to maintain a consistently low temperatures of the extremities.
15871080|NCT03873272|Device|Compression Therapy|Study participants will wear Sigvaris Secure Arm Sleeves and Gloves on bilateral upper extremities. The sleeves and gloves provide 20-30mmHg of compression. Subjects will wear Sigvaris CompreFlex Lite compression garments on the lower extremities which includes a transition liner with a compressive foot, providing 20-30mmHg of compression on the lower leg and 15mmHg on the toes and feet. AccuTabs will be placed along the CompreFlex Lite to easily and accurately set the compression level at 20-30mmHg. With each chemotherapy infusion, patients will wear the sleeves/gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.
15871081|NCT03873272|Device|Loose glove/sock|Study participants will wear a non-compressive sleeve and loosely fitting glove on bilateral arms and hands. They will also wear a non-compressive Sigvaris Basic Liner with the CompreFlex Lite loosely applied over it. The investigators will verify that no compression is applied via using an interface pressure sensor (PicoPress). The maximum level of allowed pressure for garments will be 3mmHg. If the pressure reading is greater than 3mmHg, then a larger garment size will be used. Measurements with the pressure sensor will be repeated as needed to ensure a low pressure level of less than 3mmHg. With each chemotherapy infusion, patients will wear the gloves and socks for a total of 90-120 minutes, beginning 15 minutes before the start of the infusion and until 15 minutes after the end of the infusion.
15871082|NCT03873259|Device|Burst Wave Lithotripsy|Fragment upper urinary tract stones
15871083|NCT03873246|Drug|OC-01|OC-01
15871084|NCT03873246|Drug|Placebo|placebo
15871085|NCT03873233|Device|Aisys Carestation ventilator and normal endotracheal tube|Fraction of Inspired Oxygen (FIO2) 0.3 End Expiratory Pressure (EEP) at +5 cm H2O Ratio of duration of inspiration to the duration of expiration (I:E ratio) 1:1 Tidal Volume: 6 mL/kg Zero inspiratory pause Respiratory frequency will be adapted to produce an End-Tidal CO2 35-40 mmHg
15871086|NCT03873233|Device|Evone ventilator and Tritube|Fraction of Inspired Oxygen (FIO2) 0.3 Ratio of duration of inspiration to the duration of expiration (I:E ratio) 1:1 End Expiratory Pressure (EEP) at +5 cm H2O Flow: start with 10 L/min and adjusted along with the peak inspiratory pressure to produce a tidal volume of 6 mL/kg and End-Tidal CO2 35-40 mmHg
15871087|NCT03873220|Device|Wrist Actigraphy Devices|A watch-like wearable sensor
15871088|NCT03873220|Device|Sleep Monitor|Remote Sensor
15871089|NCT03873220|Device|Polysomnography|Sleep Monitor
15871090|NCT03873220|Device|Videography|Thermal Camera
15871091|NCT03873207|Device|PopSole™ offloading device|Offload Device Distribution to remain in use at all times during ambulation and activity instruction to stay off of feet as much as possible for 3 days, then limit ambulation to 10 minutes per hour for 4 weeks and no sports, kicking, running or exercise for 4 weeks. Devices will be provided for both feet to maintain symmetry and gait stability between the two feet.
15871092|NCT03873207|Device|padded insole|the control arm will be provided with standard padded insole to wear inside footwear
15871093|NCT03873194|Other|Meditation|Participants will be instructed to find a comfortable position, with a straight back, feeling the general state of their bodies (tensions, pains, heat, cold, etc.), to relax and pay attention to their own breathing, being aware of the air that gets into and out of the lungs. The women will be told that whenever their attention disperses (to another focus such as a thought, a sound, a body sensation, a judgment, etc.) they should go back to the original focus (breathing) with no feeling/judgment about the loss of focus. The practice involves focus and attention exercises and the gradual insertion of other anchors (focus points) as participants improve their skills in this practice.
15871094|NCT03873194|Other|conventional treatment|"Early prenatal care, when possible, is recommended as the first measure. Prenatal appointments usually take place fortnightly or weekly for hypertensive pregnant women. Extensive lab testing including specific tests for the first trimester, as well as tests for the diagnosis of superimposed pre-eclampsia and for the evaluation of lesions in target organs.
~Drug treatment is only used when non-drug measures against hypertension are inefficient to decrease blood pressure levels and diastolic pressure is 90 mmHg or higher (in the first half of pregnancy) and over 100 mmHg (after 20 weeks)."
15871095|NCT03873181|Device|HEMOBLAST™ Bellows|Surgeon has chosen to use HEMOBLAST™ Bellows as an adjunct to hemostasis when control of minimal, mild, or moderate bleeding by conventional procedures is ineffective or impractical in laparoscopic abdominal, gynecological, or urological surgeries.
15871096|NCT03873168|Device|HEMOBLAST™ Bellows|Surgeon has chosen to use HEMOBLAST™ Bellows as an adjunct to hemostasis when control of minimal, mild, or moderate bleeding by conventional procedures is ineffective or impractical in gynecological, urological, vascular, ENT and head and neck surgeries.
15871097|NCT03873155|Behavioral|Mindfulness Based Cognitive Therapy|Mindfulness based cognitive group therapy (MBCT) is a structured eight-week programme (although an extra introductory week will be added in the current study) that combines mindfulness-based exercises with cognitive therapy.
15871098|NCT03873142|Behavioral|Mindful Parenting|The mindful parenting intervention is an adaption for parents of the Mindfulness-Based Cognitive Therapy (MBCT) for depression (Kabat-Zinn, 1990), and the Mindful-Based Stress Reduction program (MBSR; Kabat-Zinn, 1990). The mindful parenting intervention will follow the manual developed by Bögels and Restifo (2014). The intervention consists of 9x3hour sessions. Eight of these sessions are run on consecutive weeks and the final session is run eight weeks after the eighth session. These groups involve group discussions around parenting, meditation exercises, and yoga, amongst other things.
15871099|NCT03873129|Behavioral|mobile health app (mHealth)|A-CHESS is a mobile health app for participants to interact with their treatment team for 12 months.
15871100|NCT03873116|Drug|BCX7353 capsules|BCX7353 capsules administered orally once daily
15871101|NCT03873116|Drug|BCX7353 capsules|BCX7353 capsules administered orally once daily
15871102|NCT03873116|Drug|Placebo oral capsule|Matching placebo capsules administered orally once daily
15871103|NCT03873090|Other|SBRT|hypofractionated accelerated RT for prostate cancer with FFF (Free Flattened Filter) beam. The schedule will be [ 4 x 9.5 Gy = 38 Gy ] delivered in 5 alternative days, corresponding to an NTD2 between 95 and 119 Gy for an α/β estimate between 3 and 1.5 Gy.
15871104|NCT03873077|Procedure|local infiltration analgesia|10 mL ropivacaine 7.5 mg/mL and 10 mL lidocaine 10 mg/mL
15871105|NCT03873051|Behavioral|Challenge-Focused Program|Participants receiving the Challenge-Focused intervention will complete an 8-week group program. Group sessions meet once per week for 90 minutes and include three components - discussion-based health promotion initiative, team-based physical activity games/activities, and team-based goal-setting and behavioral skills training. Among participants with high autonomous motivation, those receiving the Challenge-focused intervention are expected to show greater improvement from baseline to post- in total PA than those receiving the Rewards-Focused intervention.
15871106|NCT03873051|Behavioral|Rewards-Focused Program|Participants receiving the Rewards-Focused intervention will complete an 8-week group program. Group sessions meet once per week for 90 minutes and include three components - discussion-based health promotion initiative, group-based walking program, and individual-based goal-setting and behavioral skills training with partner-based contracts and financial incentives. Among participants with high controlled motivation, those receiving the Rewards-focused intervention are expected to show greater improvement from baseline to post- in total PA than those receiving the Challenge-Focused intervention.
15871107|NCT03873038|Drug|MK-2060|"Part 1: Single doses (8 mg, 20 mg, or 40 mg) of MK-2060 will be administered via IV infusion on Day 1.
~Part 2: Three doses of 25 mg of MK- 2060 administered via IV infusion on Days 1, 3 and 5; Followed by single doses of 25 mg of MK-2060 administered via IV infusion on Days 8, 15, and 22."
15871108|NCT03873038|Drug|Placebo|Part 1: Single dose of placebo will be administered via IV infusion on Day 1. Part 2: Three doses of placebo administered via IV infusion on Days 1, 3 and 5; Followed by single doses of placebo administered via IV infusion on Days 8, 15, and 22.
15871109|NCT03873025|Combination Product|Pembrolizumab and CXD101|Pembrolizumab is a humanised monoclonal antibody which targets the programmed cell death 1 (PD-1) receptor. It blocks a protective mechanism on cancer cells, and allow the immune system to destroy these cancer cells. CXD101 is a histone deacetylase (HDAC) inhibitor which kills cancer cells by blocking the vital functions of HDAC enzymes.
15871110|NCT03872999|Other|Functional brain imaging without any contrast agent|"During the functional magnetic resonance imaging (fMRI) protocol, the subject will perform the attentional task while whole-brain activity will be recorded using Echo Planar Imaging (EPI) that measures the Blood Oxygen Level Dependent (BOLD) signal (2x2x2 isotropic voxels, Echo Time (ET) = 30 ms, Repetition Time (RT) = 2.5 sec). The functional session will be subdivided into several parts (Runs, duration: 10-15 min). Together with the functional data, the protocol will include a structural scan (T1 weighted, 1x1x1 mm voxels; duration 5-7 min) and a field mapping sequence (duration: 1 min)."
15871111|NCT03872986|Device|SDF|Combined Silver Diamine Fluoride (SDF) and Potassium Iodide (KI)
15871112|NCT03872986|Device|Giomer|Beautifil II dental restorative material
15871113|NCT03872986|Device|GIC|Equia forte dental restorative material
15871114|NCT03872973|Other|Neuromuscular Training|"The experimental group will perform neuromuscular exercise for 6 weeks.
~The other experimental group will perform neuromuscular exercises with strobe glasses."
15871115|NCT03872973|Other|Strobe Glasses|Stroboscopic glasses, which is characterized by intermittent vision obstruction, is a clinical tool that allows clinicians to examine sensory feedback in a progressive manner without fully seeing visual information.
15871116|NCT03872960|Procedure|Transfer to cardiac arrest centre|Patients in the intervention arm will be taken directly to a the catheter lab of a heart attack centre.
15871117|NCT03872947|Biological|TRK-950|Intravenously over 60 minutes
15871118|NCT03872947|Drug|Irinotecan|Intravenously over 30 - 90 minutes
15871119|NCT03872947|Drug|Leucovorin|Intravenously over 30 - 90 minutes
15871120|NCT03872947|Drug|5-FU|Intravenously bolus and intravenously for two days
15871121|NCT03872947|Drug|Gemcitabine|Intravenously over 30 minutes
15871122|NCT03872947|Drug|Cisplatin|Intravenously over 60 minutes
15871123|NCT03872947|Drug|Carboplatin|Intravenously
15871124|NCT03872947|Biological|Ramucirumab|Intravenously over 60 minutes
15871125|NCT03872947|Drug|Paclitaxel|Intravenously
15871126|NCT03872947|Biological|Nivolumab|Intravenously over 30 minutes
15871127|NCT03872947|Biological|Pembrolizumab|Intravenously over 30 minutes
15871128|NCT03872947|Drug|Imiquimod Cream|Topically
15871129|NCT03872947|Biological|Bevacizumab|Intravenously over 90 minutes for the first dose, over 60 for the second dose and over 30 minutes for all subsequent doses
15871130|NCT03872947|Biological|Ipilimumab|Intravenously over 90 minutes
15871131|NCT03872934|Behavioral|implant anxiety|to determine the type of music that reduces anxiety in patients undergoing implant surgery.
15871132|NCT03872921|Drug|norUrsodeoxycholic Acid|oral treatment
15871133|NCT03872908|Device|Chilled gloves|Chilled glove for non-dominant hand (patients treated with paclitaxel)
15871134|NCT03872908|Device|Surgical gloves|Surgical gloves (patients treated with oxaliplatine)
15871135|NCT03872869|Other|Hip school or Tai CHi for arthritis|Eighty-nine individuals were randomized to one of the three intervention groups 30 individuals to Tai Chi,30 individuals to Hip School and 29 individuals to the control group
15871136|NCT03872856|Device|BP-ICAN|"One of two home blood pressure monitor devices will be used.
~Omron 7 Series Wrist cuff
~Omron 10 Series Upper Arm cuff"
15871137|NCT03872843|Drug|Norco 5milligram-325milligram Tablet|Designated coated 7 days supply of pain medication (Norco 5 milligram-325milligram Tablet) will be sent home with discharged subjects. Pain medication is administered/scheduled 4 times per day until the stent will be removed in clinic a week later.
15871138|NCT03872843|Drug|Ibuprofen 400 MILLIGRAM in 1 TABLET ORAL TABLET, FILM COATED|Designated coated 7 days supply of pain medication (Ibuprofen 400 milligram) will be sent home with discharged subjects. Pain medication is administered/scheduled 4 times a day as needed until the stent will be removed in clinic a week later.
15871139|NCT03872830|Drug|Felbinac Trometamol Injection|"Felbinac Trometamol Injection diluted to 100 ml with 0.9% sodium chloride injection,a 30-minute period using a Microinjection pump.
~One dose at 8h and 16h after the start of the first dose,the first intravenous infusion was started at the end of the operation (Skin suture completes the last stitch).the drug was given 3 times,3 times/day,once every 8 hours."
15871140|NCT03872830|Drug|Placebos|"Placebo diluted to 100 ml with 0.9% sodium chloride injection,a 30-minute period using a Microinjection pump.
~One dose at 8h and 16h after the start of the first dose,the first intravenous infusion was started at the end of the operation (Skin suture completes the last stitch).the drug was given 3 times,3 times/day,once every 8 hours."
15871141|NCT03872817|Other|Intervention ProLiSMentAl|"Using different methods and pedagogical techniques, mental health literacy psychoeducational intervention called ProLiSMentAl consist of 4 sessions of 90 minutes: 1) improvement social anxiety recognition; 2) prevention strategies; 3) self-help strategies; 4) knowledge of first aid strategies and 5) knowledge of professionals and treatments available."
15871142|NCT03872804|Procedure|Autologous punch mini grafts:|"Under local anesthesia, multiple 1mm holes will be made in the depigmented treatment area using 1mm punch graft instrument inserted to a depth of 2-4 mm to remove a small column of depigmented skin that is to be discarded. The punches will be situated at or very close to the border of the lesion to avoid leaving an achromic fissure and will be separated by 5-8 mm distance from each other.
~On the donor area mostly is the gluteal area, punches will be harvested using the same sized punches very close to each other so that maximum number of grafts can be taken from a small area.
~Then the harvested-punch minigrafts will be inserted into the recipient chambers, pressed firmly by saline soaked gauge for hemostasis and secured by sterile strips or a compression bandage if applicable."
15871143|NCT03872804|Procedure|Transverse needling|Needling will be done for selected treatment patch using a 30 G disposable insulin syringe, going from the pigmented margins of the lesion into the vitiliginous patch, Position of the needle will be kept close to the dermoepidermal junction and movement will be from normal skin towards the lesion. Needle pricks may lead to oozing of a small drop of blood which will be managed by physical pressure. No dressings will be needed. The procedure will be repeated for selected lesions weekly for a duration of 3 months.
15871144|NCT03872804|Procedure|Punch minigrafts followed by transverse needling|In a third lesion, punch minigrafts will be done as mentioned in line 1 and will be left to stabilize for 3 months then transverse needling will be done weekly for the margins of the lesion as well as the areas of the punch grafts toward the vitiliginous area.
15871145|NCT03872804|Other|Oral pulse steroid with narrow band|"A fourth lesion will be chosen as a control lesion, to which no surgical treatment will ba attempted.
~All lesions will receive NB-UVB therapy according to standard protocol twice weekly and the patients will continue on the oral mini pulse dexamethasone at 2.5 mg dose for two consecutive days weekly all through the study period"
15871146|NCT03872791|Biological|KN046|KN046 at a dose level of 3 or 5 mg/kg via intravenous infusion on Days 1 and 15 of 28-day cycle
15871147|NCT03872791|Drug|Nab-paclitaxel|Nab-paclitaxel at dose level of 100 mg/m2 via intravenous infusion on Days 1, 8 and 15 of 28-day cycle
15871148|NCT03872778|Drug|[177Lu]-NeoB|[177Lu]-NeoB: peptide receptor radionuclide therapy
15871149|NCT03872778|Drug|[68Ga]-NeoB|[68Ga]-NeoB radioactive diagnostic agent
15871150|NCT03872765|Device|Laser surgery|Use of CO2 laser to perform surgeries to treat chronic anal fissure
15871151|NCT03872752|Behavioral|FL lay leader training and workshop implementation|Intervention components will include a training course for community lay leaders, enabling them to acquire the skills to lead food literacy workshops. This includes raising their knowledge about nutrition recommendations and food labels, raisin self efficacy, and improving nutrition related organization and preparation skills.
15871152|NCT03872739|Procedure|enhanced computed tomography|undergoing enhanced computed tomography
15871153|NCT03872700|Drug|Intranasal fentanyl|Fentanyl Citrate
15871154|NCT03872700|Drug|Placebo|Sterile Water Up to 5Cc
15871155|NCT03872687|Device|single tufted brush with IDB|Subjects in this group will receive a single tufted brush and interdental brushes of an appropriate size that will fit the interdental spaces around the implant.
15871156|NCT03872687|Device|interdental brushes|Subjects in this group will only receive interdental brushes
15871157|NCT03872674|Biological|high-flow humidified oxygen-delivery system (OptiFlow THRIVE)|stand oxygenation arm will receive oxygen at 5 L/min via nasal cannula, while Optiflow THRIVE arm will receive oxygen at 50 L/min via Optiflow THRIVE during the procedure.
15871158|NCT03872661|Drug|IBI308|IBI308 was given 200 mg iv infusion on day 1 of each 21-day cycle for 4 cycles.
15871159|NCT03872661|Drug|Bevacizumab|Bevacizumab was administered at a dose of 15 mg/kg on day 1 of each 21-day cycle for 4 cycles.
15871160|NCT03872661|Drug|Pemetrexed|Pemetrexed was given 500 mg/m^2 i.v. injection on day 1 of each 21-day cycle for 4 cycles.
15871161|NCT03872661|Drug|Carboplatin|Carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 5 i.v. on day 1 of each 21-day cycle for 4 cycles.
15871162|NCT03872661|Procedure|Thoracic surgery|Surgery will be performed at least 21 days after the last dose of neoadjuvant therapy.
15871163|NCT03872635|Other|oral carbohydrate liquid|patients undergoing neoadjuvant chemotherapy and radical hysterectomy with bilateral pelvic lymph node dissection were randomized to receive 300mL of an oral carbohydrate liquid supplement 2 hour before surgery
15871164|NCT03872622|Other|Blood tests, intestinal biopsies, stool samples, environmental exposure questionnaire and FFQ questionnaire|Blood tests, intestinal biopsies, stool samples, environmental exposure questionnaire and FFQ questionnaire.
15871165|NCT03872596|Drug|Seroquel IR 300mg|Administered during Part A, administered orally BID with water, over 5 days.
15871166|NCT03872596|Drug|Seroquel IR 25mg|Administered during Part B, as a single, 25mg dose taken with water.
15871167|NCT03872596|Drug|Quetiapine Formulation A 300mg|Administered during Part A, administered orally BID with water, over 5 days.
15871168|NCT03872596|Drug|Quetiapine Formulation B 300mg|Administered during Part A, administered orally BID with water, over 5 days.
15871169|NCT03872596|Drug|Quetiapine Formulation 25mg|Administered during Part B, as a single, 25mg dose taken with water.
15871170|NCT03872583|Other|Understanding MRI in MS (website)|Access to an innovative, interactive and evidence-based online education tool about MRI in multiple sclerosis.
15871171|NCT03872583|Other|Control website|Access to a specifically designed control website containing information on MRI in MS freely available on the websites of major European MS self-help organizations.
15871172|NCT03872570|Drug|Phenylephrine|intravenous administration
15871173|NCT03872570|Drug|Norepinephrine|intravenous administration
15871174|NCT03872557|Dietary Supplement|Tyrosine (TYR) Supplementation|L-Tyrosine dietary supplement will be provided as 500 mg capsules and 4 (four) 500 mg capsules are to be given before OGTT. The capsules are formed from animal gelatin, and the contents are formulated with magnesium stearate as a flow agent, but without binders, coatings or colorings and also have no added flavorings, sugars, salt, artificial sweeteners, preservatives or salicylates. The capsules are to be administered with less than eight ounces of water to minimize dilution of gastric acidity.
15871175|NCT03872518|Device|Urovac|The Urovac is simply a regular plastic handheld urinal attached by tubing to a pump that evacuates urine to a reservoir. The Urovac is simply a regular plastic handheld urinal attached by tubing to a pump that evacuates urine to a reservoir. There is also a removable cloth-covered platform to reduce spills.
15871176|NCT03872505|Drug|Durvalumab|IV administration of 5 treatments;every 2 weeks for 2 treatments and then every 4 weeks for 3 treatments
15871177|NCT03872505|Radiation|Radiation Therapy|The second dose of durvalumab will be given in conjunction with an RT boost, consisting of 8 Gy in 3 fractions for a total of 24 Gy.
15871178|NCT03872505|Drug|Carboplatin|IV administration weekly for 12 weeks
15871179|NCT03872505|Drug|Paclitaxel|IV administration every week for 12 weeks
15871180|NCT03872492|Other|Digital Assessment on mobile|"The digital assessment is composed on 5 tests:
~My daily survey
~My evaluation
~My cognition
~My emotions
~My voice
~Data will also be collected passively."
15871182|NCT03872453|Drug|BHV3500 (zavegepant) 10mg|one dose
15871183|NCT03872453|Drug|BHV3500 (zavegepant) 20mg|one dose
15871184|NCT03872453|Drug|BHV3500 (zavegepant) 5mg|one dose
15871185|NCT03872453|Drug|BHV3500 (zavegepant) matching placebo|one dose
15871186|NCT03872453|Device|Intranasal Aptar Pharma Unit Dose System|one dose intranasal device
15871187|NCT03872427|Other|Pharmacodynamic Study|Correlative studies
15871188|NCT03872427|Drug|Telaglenastat Hydrochloride|Given PO
15871189|NCT03872414|Behavioral|Anterior cingulate cortex activation|"Functional Magnetic Resonance Imaging Participants in the experimental group will be trained using functional magnetic resonance imaging to regulation brain activity in anterior cingulate cortex.
~The anterior cingulate cortex is a brain region that is known to be involved in emotion processing. Activation of this region is expected to improve emotion processing."
15871190|NCT03872414|Behavioral|Primary auditory cortex activation|"Functional Magnetic Resonance Imaging Participants in each group will be trained using functional magnetic resonance imaging to regulation brain activity in primary auditory cortex. The primary auditory cortex is a brain region that is NOT specifically involved in emotion processing. Activation of this region is NOT expected to improve emotion processing; and thus activation of this brain region serves as control/placebo condition in the current design (placebo comparator)."
15871191|NCT03872401|Drug|Evolocumab|Administered subcutaneously using an autoinjector pen.
15871192|NCT03872401|Drug|Placebo|Administered subcutaneously using an autoinjector pen.
15871193|NCT03872388|Drug|Atorvastatin|"Patients will receive Atorvastatin per ASCVD guidelines dosed as either a moderate intensity (20mg/day) or high intensity statin (80mg/day). Tablets are available in either 20mg or 80mg and will be dispensed as per standard of care for up to 24 months as part of the study.
~Patients may also receive capecitabine concurrently with Atorvastatin per physician discretion as standard of care. Standard of care dosing of Capecitabine is a 21 day cycle consisting 14 days on and 7 days off. The starting dosing will be per physician discretion, but may be up to 2500mg/m2 per day."
15871194|NCT03872388|Drug|Capecitabine|Patients not eligible to receive atorvastatin in group II will be enrolled into non-statin observation group with/without capecitabine treatment. Capecitabine administration will be dosed as per standard of care. Standard of care dosing of Capecitabine is a 21 day cycle consisting 14 days on and 7 days off. The starting dosing will be per physician discretion, but may be up to 2500mg/m2 per day.
15871195|NCT03872375|Dietary Supplement|Meal-Replacement Therapy|The meal replacement shake, consumed once per day on two consecutive days, will over a given week lead to negative energy balance and induce weight loss.
15871196|NCT03872375|Behavioral|Dietary Counseling|A Registered Dietitian of Nutrition will provide consultation on how to induce moderate weight loss.
15871197|NCT03872362|Diagnostic Test|radiomics|The high-throughput extraction of large amounts of quantitative image features from medical images
15871198|NCT03872349|Other|Monounsaturated fatty acids diet|During 4 weeks, subjects eat a diet high in monounsaturated fatty acids and will have a duodenal gastroscopy and a kinetic study at the end of the 4-week period.
15871199|NCT03872349|Other|Saturated fatty acids diet|During 4 weeks, subjects eat a diet high in saturated fatty acids and will have a duodenal gastroscopy and a kinetic study at the end of the 4-week period.
15871200|NCT03872336|Drug|Experimental labetalol dose|Subjects who have sustained severe hypertension (SBP≥160 mmHg and/or DBP≥110 mmHg), 15 min apart receive the experimental dosing of labetolol. Subjects in both groups are managed following the standard guidelines established by ACOG (Committee Opinion #623). For each successive episode of hypertension treatment, patients are asked a set of questions to monitor for adverse medication side-effects. The fetus is electronically monitored for four hours after the last IV dose.
15871276|NCT03871699|Drug|Ferric carboxymaltose|Administration of Ferric Carboxymaltose intravenously, one dose only.
15871201|NCT03872336|Other|Current standard of care|Subjects who have sustained severe hypertension (SBP≥160 mmHg and/or DBP≥110 mmHg), 15 min apart receive the standard dosing of labetolol. Subjects in both groups are managed following the standard guidelines established by ACOG (Committee Opinion #623). For each successive episode of hypertension treatment, patients are asked a set of questions to monitor for adverse medication side-effects. The fetus is electronically monitored for four hours after the last IV dose.
15871202|NCT03872323|Procedure|Endovascular treatment|The arteries injuries are repaired by endovascular treatment.
15871203|NCT03872323|Procedure|Open surgery|The arteries injuries are repaired by open surgical operation.
15871204|NCT03872310|Device|STARSTIM|Right DLPC was located as F4 according to the international 10-20 EEG system. Anodal tDCS was delivered with the anodal pole on the right DLPFCand the cathodal pole on the left cheek of the participant to avoid contaminating other brain regions during electrical stimulation via a pair of rubber electrodes housed in saline-soaked sponge coverings (5x5 cm^2). The direct current was applied with 1.5 mA for 15 min which can facilitate visual short-term memory and create an excitatory effect for up to 90 min. The anodal tDCS stimulated the right DLPC for 15 min with 1.5 mA in active tDCS condition. The sham tDCS condition followed identical tDCS protocol and same 15-min duration except the stimulation time only lasted for the initial 30s so that the participants felt the same initial tingling sensation (if any, only in some participants) but without the actual stimulation. The investigators will perform assessments of adverse effects after each session by a standardized questionnaire.
15871205|NCT03872297|Dietary Supplement|Placebo supplement|"Consumption of a non active food complement during 3 months.
~Tests performed :
~2 blood tests :
~2 body composition analysis via Dual-energy X-ray absorptiometry (DXA)
~2 stool collections The first one of these analysis was performed at the beginning, second at the end of the study."
15871206|NCT03872297|Dietary Supplement|Naticol supplement|"Consumption of the active food complement during 3 months containing Naticol.
~Tests performed :
~2 blood tests :
~2 body composition analysis via Dual-energy X-ray absorptiometry (DXA)
~2 stool collections The first one of these analysis was performed at the beginning, second at the end of the study."
15871207|NCT03872284|Other|oculomotor movement recordings, neurovisual assessment|Each participant will have a neurovisual assessment and an oculomotor movement recording with an eye tracker (infra red cameras).
15871208|NCT03872271|Procedure|ileal pouch-anal anastomosis with diverting loop ileastomy|Defunctioning ileostomy has demonstrated its benefits (rate and seriousness of anastomotic leakage) in cancer for low colorectal and coloanal anastomoses, whereas there are no such good quality evidences in case of ileal pouch-anal anastomosis (IPAA) performed for inflammatory bowel disease (IBD). However, most surgical teams do protect systematically IPAA by an ileostomy.
15871209|NCT03872271|Procedure|ileal pouch-anal anastomosis with diverting loop ileastomy|Defunctioning ileostomy has demonstrated its benefits (rate and seriousness of anastomotic leakage) in cancer for low colorectal and coloanal anastomoses, whereas there are no such good quality evidences in case of ileal pouch-anal anastomosis (IPAA) performed for inflammatory bowel disease (IBD). However, most surgical teams do protect systematically IPAA by an ileostomy.
15871210|NCT03872258|Behavioral|Control|Counseling on physical activity
15871211|NCT03872258|Behavioral|Intervention group|Program of combined exercise and a Smartband for 6 months.
15871212|NCT03872245|Biological|Probiotics|The patients will receive Adomelle 1caps/12h during 10 weeks
15871213|NCT03872245|Procedure|PENS T6|The patients will undergo percutaneous electrical neurostimulation of dermatome T6 weekle, during 10 weeks
15871214|NCT03872232|Drug|Ezetimibe/Rosuvastatin|PO, Once daily(QD), 8weeks
15871215|NCT03872232|Drug|Telmisartan|PO, Once daily(QD), 8weeks
15871216|NCT03872219|Combination Product|Nature-based materials|In the intervention arm, theycontain inactive and slowly-growing environmental bacteria and other microbiota. In the placebo arm, they do not contain the microbiota.
15871217|NCT03872206|Biological|HPN536|Dose escalation: HPN536 will be administered once weekly via IV infusion Dose expansion: HPN536 will be administered at the RP2D once weekly via IV infusion
15871218|NCT03872193|Other|Exercise|Virtual Reality Exercies
15871219|NCT03872180|Drug|Bendamustine|Given IV
15871220|NCT03872180|Biological|Obinutuzumab|Given IV
15871221|NCT03872180|Drug|Venetoclax|Given PO
15871222|NCT03872167|Device|BIPAP, Intelligent automatic mode defined by assured volume with pressure support|Correction of night ventilation through an automatic mode of ventilation with assured volume with pressure support
15871223|NCT03872167|Device|BIPAP, manual tritration.|Correction of night ventilation through a manual titration of non-invasive mechanical ventilation using polysomnography.
15871224|NCT03872154|Other|Checklist-guided shared decision-making|"Physicians will receive a checklist and a decision aid for shared decision-making during code status discussion.
~Ancillary project: Physicians will receive a checklist to communicate the futility."
15871225|NCT03872141|Diagnostic Test|Quantitative measures of reduction in Chemotherapy Induced Neuropathy (CIPN) and Cognitive Impairment (CICI) in patients with stage I-III breast cancer|Quantitative measures that include additional aspects of peripheral neuropathy, such as pain, thermal allodynia, numbness and tingling are needed. We propose to evaluate several pharmacodynamics biomarkers in patients before and during chemotherapy: changes in nerve conduction velocity and amplitude, quantitative sensory testing (QST), computer based cognitive assessment, and rate of drop-out from treatment. The tests from this list that best correlate with decreased CIPN would be added to EORTC QLQ-CIPN20 scores and will provide an early indication of CIPN and/or CICI.
15871226|NCT03872128|Drug|Pregnenolone|300mg
15871227|NCT03872128|Drug|Pregnenolone|500mg
15871228|NCT03872128|Other|placebo|placebo
15871229|NCT03872115|Device|PDVibe2|The PDVibe2 is owned by Resonate Forward, LLC and will be loaned to Virginia Commonwealth University (VCU) for this project. The device is non-invasive, lightweight, untethered, contains a rechargeable battery, and is worn on both feet and ankles. PDVibe2 delivers vibration when activated by an easy to access switch on the device or by remote. The internal circuitry has been miniaturized, is encased in a small box, and is attached to the ankle using a soft flexible band.
15871230|NCT03872089|Other|Infrared Thermography|Measurements of the temperature of the plantar arch by thermal imaging (Infrared Thermography)
15871277|NCT03871686|Behavioral|Brief Internet-based Behavioral Activation Intervention|A brief Internet-based behavioral activation intervention consisting of 4 sessions.
15871231|NCT03872076|Other|Experimental|"The Drom Jump technique with the legs flexed will be performed with the patient standing in front of a bench 30 cm high by 100 cm wide. The physiotherapist will be placed lateral to the athlete. The subject will be asked to jump up from the box or bench, with the hip and knees in semi-reflexion, with his hands on his hip and he will be asked for an explosive jump, followed by a jump downwards falling the floor of the same way.
~The technique of lateral jumps on cones will be carried out by means of unipodal jumps, achieving a distance of 50 cm between cones. The physiotherapist will stand in front of the athlete. The subject will be asked to perform a lateral unipodal explosive jump by flexing the hip and knee."
15871232|NCT03872076|Other|Control|"Elastic bands will be combined with isometric exercises in 3 sets of 10 repetitions each. The exercises they will perform are front squat. On the one hand, separating the legs at the height of the shoulders with hip and knee flexion, with the elastic band above the knees, maintaining the position 20 seconds.
~In the following exercise, with the elastic band on the ankle, in unipodal support at the same time that the contralateral limb is free of support, the hip will be flexed at 45º with full knee extension, requesting the athlete to keep the tension 20 seconds, performing 3 sets of 10 repetitions."
15871233|NCT03872063|Other|Experimental|The intervention by myofascial induction will consist of the application of two techniques: global technique of myofascial induction of the pectoralis major muscle (once the tissue is placed in tension, the direction of fascia release in that region should be followed and as a result of the release, the caudal hand can move to the pelvis in any direction, to the right or to the left) and telescopic technique for the upper extremity of the subject's dominant arm (gently tractioning the upper limb of the subject, making a slight external rotation, so slow and progressive). The subjects will then perform the eccentric exercises, which will also be done by control group subjects
15871234|NCT03872063|Other|Control|The intervention by eccentric exercises will consist of two exercises using an elastic band. In the supine position, with the elastic band on the contralateral side attached to a fixed body perpendicular to the subject's hand performing a slow and constant movement of external rotation against resistance in an approximately 45 degree arc; holding for 5 seconds and relaxing slowly (perform 3 sets of 12 repetitions). The second exercise, with the elbow in 90 degrees of flexion and a shoulder abduction also of 90 degrees, with the elastic band in front of the subject, executing a movement against resistance performing an external rotation.
15871235|NCT03872050|Diagnostic Test|No intervention apart from tests, including interview|No interventions
15871236|NCT03872037|Procedure|Selective removal of carious tissue and restoration with Maxxion|Molars subjected to selective removal and restored with Maxxion
15871237|NCT03872037|Procedure|Control|Molars subjected to selective removal and restored with Ketac Molar Easymix
15871238|NCT03872024|Device|For the first 60 patients: 3 XXL probe prototypes of the FibroScan 630 Research Model|"After the patient informed consent form signature and during the patient pre-operative routine hospitalization, the following examinations will be done:
~An ultrasound examination
~One examination with the FibroScan® 430 mini fitted with the XL+ probe (commercial reference)
~Three examinations with the FibroScan® 630 Expert - Research model fitted with the 3 XXL probe prototypes."
15871239|NCT03872024|Device|From patient 61 to patient 120: 1 XXL probe prototype of the FibroScan 630 Research Model|"After the patient informed consent form signature and during the patient pre-operative routine hospitalization, the following examinations will be done:
~An ultrasound examination
~One examination with the FibroScan® 430 mini fitted with the XL+ probe (commercial reference)
~One examination with the FibroScan® 630 Expert - Research model fitted with 1 adjusted XXL+ probe prototype (H+F prototype probe)."
15871240|NCT03872011|Drug|Vitamin C,thiamine,hydrocortisone|"Vitamin C (2g) will be diluted in 100ml 0.9%NACL and administered ivd every 6 hours for 5 days or until participant is discharged from the ICU.
~Thiamine(200mg) will be diluted in 100ml 0.9%NACL and administered ivd every 12 hours for 5 days or until participant is discharged from the ICU. Hydrocortisone was administered 200 mg/d as a continuous infusion for 5 days or until participant is discharged from the ICU."
15871241|NCT03872011|Drug|Placebo|Normal saline (0.9% NaCl solution) volume to match all components
15871242|NCT03871998|Other|Skin barrier protection in the first 2 months of life|Skin barrier protection in the first 2 months of life using a commercially available moisturiser from birth 2 months. Twice daily, whole-body application.
15871243|NCT03871985|Procedure|Subglottic secretion lavage combined with aspiration|Ventilator-associated pneumonia preventive measures were applied to all patients according to VAP bundle. Subglottic secretion lavage combined with aspiration was performed every 4 hours: Underwent preoxygenation before cuff pressure checking, and was maintained between 30 and 35 cmH2O. After aspirating secretions from the mouth, nose, and airway, 2-5 mL distilled sterile water was instilled through the subglottic lumen, and then the negative pressure suction device is connected with the outer opening of the side cavity of endotracheal intubation for suction with a negative pressure of 100 mmHg, and each suction was kept under 15 seconds. Repeat lavage and aspiration until the irrigation fluid is clear. After washing, cuff pressure checking and was maintained between 25 and 30 cmH2O.
15871244|NCT03871985|Procedure|Subglottic secretion aspiration|Ventilator-associated pneumonia preventive measures were applied to all patients according to VAP bundle. Subglottic secretion aspiration was performed every 4 hours:Underwent preoxygenation before cuff pressure checking ,and was maintained between 25 and 30 cmH2O. After aspirating secretions from the mouth, nose, and airway, the negative pressure suction device is connected with the outer opening of the side cavity of endotracheal intubation for suction with a negative pressure of 100 mmHg, and each suction was kept under 15 seconds. Repeat suction until the secretion is completely absorbed.
15871245|NCT03871972|Drug|Umbilical Cord Blood Unit|3 infusions of umbilical cord blood (UCB) unit (TNC > 2.0ⅹ107cells/kg) each 4 months apart and take oral Sirolimus (1 mg/m2/day) for 7 days (from 3 days before UCB infusion until 3 days after UCB infusion)
15871246|NCT03871959|Drug|Pembrolizumab|200 mg, intravenous (IV), to be administered on Day 1 of every 3-week cycle i.e. Q3W.
15871247|NCT03871959|Drug|DEBIO1143|3 escalating dose level (100 mg, 150 mg, 200 mg) of Debio 1143 administered daily for 14 days over a 21-day cycle period.
15871248|NCT03871946|Diagnostic Test|oral glucose tolerance test (OGTT)|Implementation of OGTT: The patient was seated in a quiet room after 10-12 h of overnight fasting, and blood samples were drawn. Thereafter, 75 g glucose solution dissolved in 300 mL of water was administeredwithin 5 min. Two hours after this,another blood sample was drawn. During the test, the patient wasn't allowed to rest and eat, but not smoke.
15884474|NCT03770299|Other|Observation|Observation by the investigator
15871249|NCT03871933|Other|Measurement of lung function, electrocardiography, echocardiography and autonomic function|Measurement of lung function, electrocardiography, echocardiography and autonomic function
15871250|NCT03871920|Other|physical therapy treatment|any treatment chosen by treating physiotherapist
15871251|NCT03871907|Behavioral|Digital technology|Lifestyle-Focused Text Messaging
15871252|NCT03871894|Other|Indirect calorimetry based nutritional intervention till patient in ICU(Intensive care unit)|Nutrition therapy based on indirect calorimetry (IC) measurements(measured resting energy expenditure and/or substrate utilization) and to be adjusted according to the variations shown by IC.
15871253|NCT03871894|Other|Standard and fixed nutritional intervention till patient in ICU|Fixed standard nutritional therapy 40 Kcal/Kg IBW/day and 1.5 to 2 g protein /Kg IBW/Day throughout the period of ICU stay
15871254|NCT03871881|Other|Magnetic Resonance Imaging|Magnetic Resonance Imaging (MRI) of the brain's macro- and microstructures. Furthermore, brain regional interactions and activity is examined with quantitative functional-MRI (fMRI)
15871255|NCT03871881|Other|Neuropsychological assessment|A special designed neuropsychological test battery of validated tests to assess function of cognitive domains
15871256|NCT03871855|Drug|SHR-1702|Administered IV
15871257|NCT03871855|Drug|Camrelizumab|Administered IV
15871258|NCT03871842|Device|active tDCS|Considering that the daily outpatient use of tDCS equipment is not feasible for most patients, the Pain and Neuromodulation group of the Hospital de Clínicas de Porto Alegre developed a portable tDCS device for home use that has a safe protocol, in addition of being easy to use so that the patient can use it at home without help. The safety protocol embedded in the device does not, for example, allow the appliance to be used for more than 20 minutes per day. The device can also provide the assisting staff with data such as the time the patient used the equipment, providing an accurate picture of the patient's adherence to this type of equipment. This tDCS equipment for home use has already been validated in a pilot study and will be used in this work.
15871259|NCT03871842|Device|sham tDCS|The sham intervention will be applied exactly equal to active intervention, but the electric stimulus will last just for 30 seconds.
15871260|NCT03871829|Drug|Carfilzomib 20 mg/m^2|Carfilzomib 20 mg/m^2 will be administered intravenously (IV).
15871261|NCT03871829|Drug|Carfilzomib 70 mg/m^2|Carfilzomib 70 mg/m^2 will be administered IV.
15871262|NCT03871829|Drug|Dexamethasone 40 mg|Dexamethasone 40 mg will be administered as IV infusion or orally.
15871263|NCT03871829|Drug|Dara-SC 1800 mg|Dara-SC 1800 mg will be administered by SC injection.
15871264|NCT03871829|Drug|Dexamethasone 20 mg|Dexamethasone 20 mg will be administered as IV infusion or orally.
15871265|NCT03871816|Other|Saliva, Blood, or and/or Archival Tumor Tissue Collection and Analysis|Saliva, blood, and/or archival tumor tissue will be collected from the participants with metastatic PC for genomic testing to confirm DRD status.
15871266|NCT03871803|Drug|Controlled withdrawal of beta-blockers|Controlled withdrawal of previos doses of beta-blockers after diagnosis of chronotropic incompetence
15871267|NCT03871803|Diagnostic Test|Cardiopulmonary Exercise Testing|Cardiopulmonary Exercise Testing to evaluate the chronotropic incompetence and the primary endpoint (functional capacity)
15871268|NCT03871777|Other|Placebo mouthwash|Participants received placebo mouthwash (ultrapure unflavoured water) with which they rinsed their mouth for one minute, twice a day for 7 days. Resting metabolic rate and blood pressure were measured on day eight. Additionally, blood and saliva samples were taken from all the participants. Dietary records of seven days were also collected in order to confirm the foods and portion sizes consumed, preparation methods, recipes and any brand names.
15871269|NCT03871777|Other|Chlorhexidine mouthwash|After using placebo and complete all the physiological measurements, participants were given a further one-week supply of antibacterial mouthwash containing 0.2% chlorhexidine (Corsodyl, GlaxoSmithKline, UK), encouraged to rinse their mouth for one minute, twice a day for 7 more days. They returned to the laboratory in 7 days to repeat all measurements in the same order.
15871270|NCT03871764|Diagnostic Test|blood sample , doppler of uterine vessel and placenta|blood sample for factor V and doppler examination of uterine arteries , placenta pathology post partum
15871271|NCT03871751|Behavioral|Safe and Sound Protocol|The auditory intervention will consist of listening to computer-altered acoustic stimulation, designed to modulate the frequency band of vocal music passed to the participant. The frequency characteristics of the acoustic stimulation are selected to emphasize the relative importance of specific frequencies in conveying the information embedded in human speech. Modulation of the acoustic energy within the frequencies of human voice, similar to an exaggerated vocal prosody, are hypothesized to recruit and modulate the neural regulation of the middle ear muscles and to functionally reduce sound hypersensitivities and improve auditory processing.
15871272|NCT03871738|Other|Proprioceptive training|"The intervention to the experimental group will consist of the application of the protocol of proprioception exercises. Before the exercises of the protocol, a warm-up will be carried out that will last 3 minutes and consists of exercises of joint mobility and jumping rope.
~The protocol consists in carrying out two exercises per session, of 10 minutes each. A minute of rest will be implemented between the warm-up and the completion of the protocol, in addition to one minute between the two proprioception exercises in each session. The exercises will vary from week to week, and all the protocol exercises should be done barefoot. The exercise protocol proposed in this study consists of a total of 7 exercises: of unipodal and bipodal support, with unstable surfaces and postural changes."
15871273|NCT03871725|Combination Product|Sonodynamic therapy (SDT)|Sinoporphyrin sodium (DVDMS) as sonosensitizer, is dissolved in 0.9% sodium solution for following skin test and intravenous injection. 0.01mg/ml DVDMS solution (0.1ml) is prepared for skin test followed by 0.04 mg/ml DVDMS solution intravenous injection (0.2mg/kg).The target atherosclerotic lesions are marked on the corresponding skin with ultrasound guidance and underwent ultrasound exposure after 4 hours incubation. The therapeutic ultrasonic transducer is fixed to the marked skin site for 15min of each lesion. Ultrasound parameters included intensity of 1.6W/cm2 for carotid lesions, resonance frequency: 1.0 MHz and duty factor: 30%.
15871274|NCT03871712|Behavioral|Motivational interview|The participants will be called twice with 2-4 weeks interval after the randomisation. This will be after 8 weeks of sick leave.
15871275|NCT03871712|Behavioral|Stratified vocational advice|The participants will be called after the randomisation. The amount of calls/meetings will be decided after each call, but with a maximum of 4 for the high risk group. This may include physical meetings.
15871278|NCT03871673|Dietary Supplement|sweet polvilho|100 g of starch diluted in 200 ml of water at room temperature In the subsequent night the patient is crossed over to the other starch.
15871279|NCT03871673|Dietary Supplement|Cornstarch|100 g of starch diluted in 200 ml of water at room temperature In the subsequent night the patient is crossed over to the other starch.
15871280|NCT03871660|Device|FreeStyle Libre Pro|Flash glucose monitoring device. Measures patients interstitial glucose levels continuously.
15871281|NCT03871647|Drug|Beta blocker|perioperative beta blockers
15871282|NCT03871621|Drug|Diabetes Medicines|Anti-diabetic medications except SGLT2 inhibitors
15871283|NCT03871621|Drug|Dapagliflozin|Dapagliflozin tablet (10 mg)
15871284|NCT03871608|Other|Examination of functional etiologies on DTM Disorders|Evaluating functional etiologies accessible to rehabilitation, consists of 4 categories (Orofacial dyspraxia, parafunctions, posture, Chewing) and includes 11 items in total
15871285|NCT03871608|Other|Assessment of symptoms on DTM Disorders|Examining the symptoms of the patient, consists of 5 categories (Muscle examination, Areas of cellulalgic infiltrates, Mandibular kinetics, Joint sounds, Thrust)and includes 21 items
15871286|NCT03871595|Drug|BI 894416|Oral
15871287|NCT03871582|Other|No intervention|Cross-sectional
15871288|NCT03871569|Other|bucco-dental teleexpertise|A bucco-dental consultation remotely using telemedicine system
15871289|NCT03871556|Diagnostic Test|LOGIQ P6 Diagnostic Ultrasound|Ultrasound measurements of subcutaneous fat thickness
15871290|NCT03871543|Device|AquaComfort Plus|Test Lens 1
15871291|NCT03871543|Device|Acuvue Oasys 1-Day|Test Lens 2
15871292|NCT03871530|Other|Coordinate A|"PIEB Next Bolus: 45 minutes, PIEB Interval: 50 minutes, and PIEB volume: 5 mL"
15871293|NCT03871530|Other|Coordinate B|"PIEB Next Bolus: 45 minutes, PIEB Interval: 40 minutes, and PIEB volume: 6.5 mL"
15871294|NCT03871530|Other|Coordinate C|"PIEB Next Bolus: 45 minutes, PIEB Interval: 50 minutes, and PIEB volume: 8 mL"
15871295|NCT03871530|Other|Coordinate D|"PIEB Next Bolus: 45 minutes, PIEB Interval: 60 minutes, and PIEB volume: 6.5 mL"
15871296|NCT03871530|Other|Coordinate E|"PIEB Next Bolus: 30 minutes, PIEB Interval: 40 minutes, and PIEB volume: 5 mL"
15871297|NCT03871530|Other|Coordinate F|"PIEB Next Bolus: 30 minutes, PIEB Interval: 40 minutes, and PIEB volume: 8 mL"
15871298|NCT03871530|Other|Coordinate G|"PIEB Next Bolus: 30 minutes, PIEB Interval: 60 minutes, and PIEB volume: 8 mL"
15871299|NCT03871530|Other|Coordinate H|"PIEB Next Bolus: 30 minutes, PIEB Interval: 60 minutes, and PIEB volume: 5 mL"
15871300|NCT03871530|Other|Coordinate I|"PIEB Next Bolus: 15 minutes, PIEB Interval: 50 minutes, and PIEB volume: 5 mL"
15871301|NCT03871530|Other|Coordinate J|"PIEB Next Bolus: 15 minutes, PIEB Interval: 40 minutes, and PIEB volume: 6.5 mL"
15871302|NCT03871530|Other|Coordinate K|"PIEB Next Bolus: 15 minutes, PIEB Interval: 50 minutes, and PIEB volume: 8 mL"
15871303|NCT03871530|Other|Coordinate L|"PIEB Next Bolus: 15 minutes, PIEB Interval: 60 minutes, and PIEB volume: 6.5 mL"
15871304|NCT03871530|Other|Coordinate M|"PIEB Next Bolus: 30 minutes, PIEB Interval: 50 minutes, and PIEB volume: 6.5 mL"
15871305|NCT03871530|Other|Coordinate N|"PIEB Next Bolus: 30 minutes, PIEB Interval: 50 minutes, and PIEB volume: 6.5 mL"
15871306|NCT03871517|Drug|Indobufen|Indobufen inhibits platelet aggregation by reversibly inhibiting the platelet cyclooxygenase enzyme thereby suppressing thromboxane synthesis.
15871307|NCT03871517|Drug|Aspirin|Aspirin is a salicylate (sa-LIS-il-ate). It works by reducing substances in the body that cause pain, fever, and inflammation.
15871308|NCT03871504|Other|Submaximal isometric exercise|The exercise is a submaximal isometric contraction
15871309|NCT03871491|Drug|Azithromycin|The study intervention is a single 2 g dose of directly observed oral azithromycin, to be administered as four 500 mg pills or tablets directly after randomization. By random allocation, participants will receive 2 g of oral azithromycin.
15871310|NCT03871491|Drug|Placebo|Identical appearing placebo, administered as a single oral dose directly after randomization.
15871311|NCT03871478|Drug|Lidocaine|See Arm Description
15871312|NCT03871478|Drug|Bupivacaine|See Arm Description
15871313|NCT03871478|Drug|Lidocaine and Bupivacaine|See Arm Description
15871314|NCT03871465|Drug|Triamcinolone SASD injection|2ml triamcinolone (1ml/10mg) and 3ml 1% xylocain will be injected into the affected SASD bursa under ultrasound guidance.
15871315|NCT03871465|Procedure|Physiotherapy|The physiotherapy program consists of hot pack, interferential therapy, and exercise program, which includes stretch exercise, mobilization of the glenohumeral joint, manual pressure to the possible trigger points, scapular stabilization exercise, and strengthening exercise of the rotator cuff, trapezius, and serratus anterior muscles.
15871316|NCT03871465|Drug|Triamcinolone injections & Physiotherapy|"2ml triamcinolone (1ml/10mg) and 3ml 1% xylocain will be injected into the affected SASD bursa under ultrasound guidance.
~The physiotherapy program consists of hot pack, interferential therapy, and exercise program, which includes stretch exercise, mobilization of the glenohumeral joint, manual pressure to the possible trigger points, scapular stabilization exercise, and strengthening exercise of the rotator cuff, trapezius, and serratus anterior muscles."
15871317|NCT03871452|Procedure|Ankaferd Blood Stopper in theTraumatic Bleeding|"ankaferd blood stpper They were trained to apply compression of approximately 3-kg weight after irrigation with saline in patients with active bleeding who met inclusion criteria. Bleeding was controlled in every minute and data were collected. Traditional methods such as primary suturing were performed in patients whose bleeding did not stop within 10 minutes. Patients whose bleeding was stopped were monitored for half an hour for bleeding recurrence.
~The patients were divided into two groups; ones treated by ABS soaked wet compresses (group I) and ones treated by dry sponge compresses"
15871318|NCT03871439|Drug|PF-05221304 Formulation A|50mg
15871319|NCT03871439|Drug|PF-05221304 Formulation B|50mg
15871320|NCT03871426|Procedure|manual therapy|Manual Cervical Traction, Trunk Stabilization Maneuver
15871321|NCT03871413|Device|TRV-chair|Repositioning maneuvers in TRV-chair
15871322|NCT03871413|Procedure|Manual repositioning maneuver|Treatment with manual repositioning maneuver
15871323|NCT03871400|Procedure|Anterior cervical discectomy and fusion|primary, 2-level, contiguous
15871362|NCT03871088|Dietary Supplement|Omega-3 fatty acids|12-week double-blind, randomized controlled trial
15871324|NCT03871387|Drug|Deep Group|"Continuous Rocuronium (Rocnium®, Hanlim Pharm. Co., Ltd., South Korea) infusion during surgery
~Titrate Rocuronium (Rocnium®) infusion rate to maintain TOF = 0 & PTC= 1~2 (TOF = train-of-four. PTC = post-tetanic count)
~TOF and PTC are assessed by acceleromyography (TOF-Watch® SX, Organon Ltd., Drynam Road, Swords, Co. Dublin, Ireland).
~At the end of surgery, IV Sugammadex (Bridion®, Merck Sharp and Dohme [MSD], Oss, the Netherlands) injection to reverse muscle relaxation.
~Sugammadex dose = 2mg/kg at TOF ≥2 or 4mg/kg at TOF < 2"
15871325|NCT03871387|Drug|Control Group|"Continuous Rocuronium (Rocnium®, Hanlim Pharm. Co., Ltd., South Korea) infusion during surgery
~Titrate Rocuronium (Rocnium®) infusion rate to maintain TOF = 1~2
~TOF and PTC are assessed by acceleromyograph (TOF-Watch® SX, Organon Ltd., Drynam Road, Swords, Co. Dublin, Ireland).
~At the end of surgery, IV Sugammadex (Bridion®, Merck Sharp and Dohme [MSD], Oss, the Netherlands) injection to reverse muscle relaxation.
~Sugammadex dose = 2mg/kg at TOF ≥2 or 4mg/kg at TOF < 2"
15871326|NCT03871361|Drug|Abatacept 125 MG/ML Prefilled Syringe|Abatacept 125 MG/ML Prefilled Syringe [Orencia] weekly
15871327|NCT03871348|Drug|SAR441000|"Pharmaceutical form: concentrate for solution for injection
~Route of administration: intratumoral"
15871328|NCT03871348|Drug|Cemiplimab REGN2810|"Pharmaceutical form: solution for injection
~Route of administration: intravenous"
15871329|NCT03871335|Diagnostic Test|Investigation of the work-related musculoskeletal disorders|Structured questionnaires will be used to determine the prevalence of the work-related musculoskeletal disorders and work-related factor. Photogrammetric method will be used to evaluate working posture.
15871330|NCT03871322|Dietary Supplement|Vitamin D and K2 supplementation|if supplementation of vitamin D and K2 changes the time to fracture healing
15871331|NCT03871322|Dietary Supplement|Vitamin D supplementation|if supplementation of vitamin D alone changes the time to fracture healing
15871332|NCT03871322|Dietary Supplement|Placebo|Placebo control group
15871333|NCT03871309|Device|Tigertriever|Mechanical Thrombectomy
15871339|NCT03871244|Procedure|Less red blood cell transfusions|The instructions given to caregivers will be to consider prescribing a red blood cell transfusion only if the hemoglobin level is ≤ 70 g per L.
15871340|NCT03871244|Procedure|More red blood cell transfusion (standard transfusion strategy in PICU)|The instructions given to caregivers will be to prescribe a red blood cell transfusion according to their usual standard practice
15871341|NCT03871231|Device|Unpinning Termination Therapy|The Cardialen External Stimulation System (CESS) is the research delivery system for the proprietary Cardialen Unpinning Therapy (UPT) therapy. The CESS is a custom designed and built research device. It is comprised of off-the-shelf commercial components (power supplies, waveform generators, laptop computer, monitor, rack, ECG system, leads, etc.) combined with a custom electrical circuit board and custom software.
15871342|NCT03871218|Biological|Hyaluronic acid group|Applicaton of topical Hyaluronic acid
15871343|NCT03871205|Biological|Neoantigen loaded DC vaccine|Patients will be vaccinated with autologous mature dendritic cells loaded with neoantigen, DC vaccine will be injected subcutaneously 6 times, once a week.
15871344|NCT03871192|Diagnostic Test|FACET JOINT UNDER CT GUIDANCE|injection of triamcinolone in the facet joint under CT guidance
15871345|NCT03871192|Diagnostic Test|NERVE BLOCK UNDER CT GUIDANCE|injection of triamcinolone around the dorsal ramus under CT guidance
15871346|NCT03871192|Diagnostic Test|FACET JOINT UNDER FLUOROSCOPY GUIDANCE|injection of triamcinolone in the facet joint under fluoroscopy guidance
15871347|NCT03871192|Diagnostic Test|NERVE BLOCK UNDER FLUOROSCOPY GUIDANCE|injection of triamcinolone around the dorsal ramus under fluoroscopy guidance
15871348|NCT03871192|Diagnostic Test|FACET JOINT UNDER ULTRASOUND GUIDANCE|injection of triamcinolone in the facet joint under ultrasound guidance
15871349|NCT03871192|Diagnostic Test|NERVE BLOCK UNDER ULTRASOUND GUIDANCE|injection of triamcinolone around the dorsal ramus under ultrasound guidance
15871350|NCT03871166|Other|Blood transfusion|"Observational post-ad-hoc design to compare patients admitted with an ARDS and separated into different groups according to their mean hemoglobin concentration during their stay on the intensive care unit.
~Approximately 1000 adult patients admitted from 2007 to 2018 to the Charite ARDS center will be enrolled in the study. They are followed up until their discharge from the ICU.
~[Time Frame: 01/2007 - 12/2018]"
15871351|NCT03871153|Device|Durvalumab|"Neoadjuvant Durvalumab 750 mg IV on Days 1, 15 and 29
~Adjuvant Durvalumab 12 weeks after undergoing surgical resection 1,500 mg IV on Day 1"
15871352|NCT03871153|Drug|Paclitaxel|Paclitaxel 45 mg/m2 IV Days 1, 8, 15, 22, 29 and +/- 36
15871353|NCT03871153|Drug|Carboplatin|Carboplatin AUC of 2 IV Days 1, 8, 15, 22, 29 +/- 36
15871354|NCT03871153|Radiation|Radiation|1.8-2.0 Gy per day (5 days/week) for a total of 45-61.2 Gy over 5-6 weeks. Treatment will be delivered using IMRT or 3DCRT using typically 6-10MV photons. Proton therapy is also allowed. 4D simulation and appropriate IGRT are encouraged. Radiation therapy must begin within one week of the first day of chemotherapy (or vice versa).
15871355|NCT03871153|Procedure|Surgical Resection|Patients will undergo repeat imaging between 4 and 12 weeks after completing neoadjuvant therapy. Those without evidence of progressive disease and found to be a surgical candidate by a thoracic surgeon will undergo surgical resection between 4 and 12 weeks after neoadjuvant therapy.
15871356|NCT03871140|Other|diagnosis|therre is no intervention diagnosis or treatment for patients
15871357|NCT03871127|Procedure|Percutaneous coronary intervention|Using sirolimus eluting stent
15871358|NCT03871127|Procedure|coronary artery bypass graft|coronary artery bypass graft
15871359|NCT03871114|Drug|Triamcinolone Acetonide in orabase|treatment of OLP with topical steroid
15871360|NCT03871101|Procedure|Scalpel|Exposure of the cover screw of osseointegrated dental implants embedded under oral mucosa by performing the soft tissue incision with scalpel for placing the healing abutment.
15871361|NCT03871101|Device|2780 nm Er,Cr:YSGG Laser|Exposure of the cover screw of osseointegrated dental implants embedded under oral mucosa by performing the soft tissue incision with erbium laser for placing the healing abutment.
15884475|NCT03770286|Device|5% Fluoride Varnish|Topical varnish
15871363|NCT03871075|Device|intermittent pneumatic compression|Intermittent pneumatic compression is a non-invasive intervention, consisting of an air pump inside inflatable cuffs that are wrapped around the feet, ankles, and calves. The cuffs rapidly inflate to a pressure of 120 mm Hg, which is sustained for three seconds, followed by rapid deflation. Participants will be asked to wear the device for two hours daily. The device will inflate 180 times/hour.
15871364|NCT03871075|Behavioral|exercise|Participants will be asked to walk for exercise five days/week, working up to 50 minutes of exercise per day. The intervention includes a) group meetings at the medical center with the coach and other PAD participants; b) regularly scheduled individual telephone check-in by the coach c) weekly remote monitoring by the coach; d) use of the activity monitor to monitor exercise intensity and duration.
15871365|NCT03871075|Device|Sham device|The sham control device is a non-invasive intervention, consisting of an air pump inside inflatable cuffs that are wrapped around the feet, ankles, and calves. The cuffs rapidly inflate to a pressure of 25 mm Hg, which is sustained for three seconds, followed by rapid deflation. Participants will be asked to wear the device for two hours daily. The device will inflate 180 times/hour.
15871366|NCT03871075|Behavioral|Health Education|Participants attend health-education lectures and receive telephone calls at the same frequency as the exercise group. On-site lectures are delivered by faculty and staff at the medical center. Telephone calls review health-related handouts from the NIA website that are mailed in advance of the telephone call. Content does not include exercise information.
15871367|NCT03871062|Procedure|Two step anesthesia|conjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times + 2% lidocaine 0.2 ml subconjunctival injection
15871368|NCT03871062|Procedure|topical anesthesia|conjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times
15871369|NCT03871049|Drug|Bupivacaine with dexamethasone|bupivacaine with dexamethasone
15871370|NCT03871049|Drug|Bupivacaine|bupivacaine
15871371|NCT03871036|Drug|Tremelimumab|See experimental arm description for more details.
15871372|NCT03871036|Drug|Durvalumab|See experimental arm description for more details.
15871373|NCT03871036|Drug|Paclitaxel|See experimental arm description for more details.
15871374|NCT03871023|Device|Smith & Nephew PICO Negative wound pressure versus standard dresing|To investigate if negative wound pressure improves wound outcome
15871375|NCT03871023|Device|PREVENA Negative pressure wound versus standard dressing|To investigate if negative wound pressure improves wound outcome
15871376|NCT03871010|Device|Midline catheter|Midline catheter is used for administration of intravenous therapy, and is inserted in a larger vein.
15871377|NCT03870997|Behavioral|Diabetes Digital Intervention|The Diabetes Digital Intervention is a digital campaign that provides interactive ways (e.g., videos, infographics, quizzes) for individuals to learn about influenza and related complications, and the importance of influenza vaccination. It is tailored to people living with diabetes and highlights the importance of influenza vaccination for this specific patient population.
15871378|NCT03870997|Behavioral|Generic Digital Intervention|The Generic Digital Intervention is a digital campaign that provides interactive ways (e.g., videos, infographics, quizzes) for individuals to learn about influenza and related complications, and the importance of influenza vaccination. It provides generic influenza vaccination interventions that can be applicable to any adult who should receive influenza vaccination.
15871379|NCT03870984|Dietary Supplement|wNUTS, low-caloric diet plus nuts|15g of nuts and 15g of hazelnuts in association with low caloric diet
15871380|NCT03870984|Other|w/oNUTS, low-caloric diet without nuts|low caloric diet
15871381|NCT03870971|Other|blood glucose measurement|After the patient has performed the manual reading, the investigator or staff member will obtain another capillary blood sample and a reference reading by means of the YSI 2300 Stat plus analyzer will be performed and recorded. If patients need more than one attempt to get a successful blood glucose reading, the number of attempts will be documented. A questionnaire needs to filled by the participant
15871382|NCT03870958|Procedure|GIC sealant (GC Fuji TRIAGE®)|Children allocated to this group will receive the same dietary advices and brushing instructions. Additionally, all MIH molars from will receive a GIC sealant (GC Fuji TRIAGE®, GC Europe, Leuven, Belgium).
15871383|NCT03870958|Procedure|Control|Children allocated to this group will receive the same dietary advices and brushing instructions.
15871384|NCT03870945|Biological|MB-CART2019.1 Dose level 1|This is a prospective, multi-center, open phase I/II trial to evaluate feasibility, dosage, safety and toxicity as well as efficacy of ex vivo expanded autologous T cells genetically modified to express anti-CD20 and CD19 immunoreceptor (MBCART2019.1) in patients with relapsed or resistant aggressive CD20 and CD19 positive B-NHL/CLL/SLL.
15871385|NCT03870945|Biological|MB-CART2019.1 Dose level 2|This is a prospective, multi-center, open phase I/II trial to evaluate feasibility, dosage, safety and toxicity as well as efficacy of ex vivo expanded autologous T cells genetically modified to express anti-CD20 and CD19 immunoreceptor (MBCART2019.1) in patients with relapsed or resistant aggressive CD20 and CD19 positive B-NHL.
15871386|NCT03870932|Other|Motor Imagery physical therapy|
15871387|NCT03870932|Other|Conventional physical therapy|
15871388|NCT03870919|Drug|Palbociclib|"The included patients will first receive the following systemic treatment according standard of care:
~Non-steroidal aromatase inhibitor (letrozole)
~Palbociclib
~Monthly Luteinizing hormone-releasing hormone (LHRH) analogue for non-menopausal patients only. Surgical bilateral oophorectomy is an acceptable option."
15871389|NCT03870919|Other|locoregional treatment|After 6 courses of systemic treatment initiation, the loco-regional treatment of the primary tumour will be performed: surgery (conservative or mastectomy) with or without radiotherapy, or radiotherapy
15871390|NCT03870906|Behavioral|Occupational-specific health talk|Health talk will provide information about hazards of tobacco (active smoking, second- and third-hand smoke), benefits of quitting smoking and methods to quit smoking.
15871391|NCT03870906|Behavioral|WhatsApp interaction|Individual WhatsApp interactions last 3-month and consist of 2 parts. First part is regular WhatsApp message. The schedule will be adjusted according to the participants' quitting status. Second part is real-time discussion intervention based on participants' socio-demographic characteristics, smoking habit at baseline and updated smoking status obtained during online conversation. At 3-month follow-up, participants who are still smoking are encouraged to join an additional 1-month online group chat moderated by a smoking cessation counselor.
15871392|NCT03870906|Behavioral|Phone follow-up/counselling service|The intervention outcomes and participants' smoking status will be followed up regularly via telephone interviews (15 - 30 minutes).
15871393|NCT03870906|Biological|Text message|Participants will receive regular text messages with similar frequency to those in the intervention group.
15871394|NCT03870893|Behavioral|hippotherapy|16weeks hippotherapy program
15871395|NCT03870880|Drug|Risperidone ISM 75 mg|Monthly intramuscular (IM) injection in the gluteal or deltoid muscle.
15871396|NCT03870880|Drug|Risperidone ISM 100 mg|Monthly IM injection in the gluteal or deltoid muscle.
15871397|NCT03870867|Other|No intervention|No intervention
15871398|NCT03870854|Procedure|PEFA VT ablation technique|Catheter ablation guided by PEFA technique
15871399|NCT03870841|Drug|PC945|PC945, nebulized
15871400|NCT03870828|Diagnostic Test|Bronchoalveolar lavage and taking bronchial mucosa samples|"Regional anesthesia and sedation with use of lidocaine and midazolam will be performed, according to anesthesia protocols applied in respective endoscopy units. Intravenous cannula will be inserted prior to BF. During endoscopy, the patient will be monitored according to safety protocols applied in respective endoscopy units.
~Bronchoalveolar lavage will be performed in the bronchus from the middle robe of right lung or the lingula of left lung (B4, B5). Localization will be chosen based on HRCT results and will be recorded in patient's medical history. Sterile solution of 0, 9% NaCl will be instilled. 200 ml fluid will be applied with a syringe in portions of 25 ml or 50 ml. It is recommended that minimum 60 % of the lavage fluid is retrieved."
15871401|NCT03870828|Diagnostic Test|6minute walk test|a submaximal exercise test which entails measurement of distance walked over a span of 6 minutes. Blood pressure, pulse oximetry are measured directly before and after the test. The participant is also periodically asked about their dyspnea sensation
15871402|NCT03870828|Diagnostic Test|Arterial blood gas|If SpO2 is measured to be < 92%, an artery (radial or femoral) is punctured in order to take a sample of arterial blood. Then, the artery is compressed in order to prevent bleeding/ hematoma.
15871403|NCT03870828|Procedure|Blood drawing|A vein will be punctured in order to take a blood sample for further tests
15871404|NCT03870815|Procedure|CABG|Patients who undergoing CABG
15871405|NCT03870815|Procedure|PCI|Patients who undergoing PCI with second-generation DES
15871406|NCT03870802|Other|Characterization of breast stem & immune system cells infiltrated in the mammary gland|Isolation, quantification and characterization of breast stem and immune cells of samples obtained during the prophylactic mastectomy in women presenting different tumor progression risks.
15871407|NCT03870776|Drug|MAP4343|Daily oral administration of MAP4343
15871408|NCT03870776|Drug|Placebo|Daily oral administration of Placebo
15871409|NCT03870763|Drug|Dimethyl Fumarate|Administered as specified in the treatment arm.
15871410|NCT03870763|Drug|Peginterferon Beta-1a|Administered as specified in the treatment arm.
15871411|NCT03870763|Drug|Placebo|Administered as specified in the treatment arm.
15871412|NCT03870750|Other|Supportive Palliative Care|focuses on relieving symptoms of stress from serious illness and care through physical, cultural, psychological, social, spiritual, and ethical aspects
15871413|NCT03870750|Other|Clinical Management|physical exercise, strength training, stress reduction, medication management, dietary recommendations, and education
15871414|NCT03870750|Other|Best Practice|Given standard of care
15871415|NCT03870750|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo HCT
15871416|NCT03870750|Other|Questionnaire Administration|Ancillary studies
15871417|NCT03870750|Other|Quality-of-Life Assessment|Ancillary studies
15871418|NCT03870750|Other|Survey Administration|Ancillary studies
15871419|NCT03870737|Device|Active TNS|Participants will receive 4-weeks nightly treatment with active TNS. Positive responders will be invited to participate in 12-month open-extension study.
15871420|NCT03870711|Drug|lidocaine spray|10% lidocaine spray 4 puffs
15871421|NCT03870711|Drug|Placebo|Sterile water 4 puffs
15871422|NCT03870698|Procedure|Laparoscopic group|The patients in laparoscopic group will underwent pylorus preserving pancreaticoduodenectomy in laparoscopic manners.
15871423|NCT03870685|Procedure|TAP Block|Transversus Plane block
15871424|NCT03870685|Procedure|Surgical Site Infiltration|Surgical Site Infiltration
15871425|NCT03870685|Drug|Exparel|liposomal bupivacaine
15871426|NCT03870672|Device|Contralaterally Controlled Functional Electrical Stimulation|Contralaterally Controlled Functional Electrical Stimulation (CCFES) uses electrical stimulation to open the weak hand. Sticky patches called electrodes are placed on the participant's affected arm to stimulate the hand muscles, and a special glove is worn on the participant's strong hand and controls the stimulator. When the participant opens the gloved hand, stimulation opens the weak hand; when they close the gloved hand, stimulation turns off and the weak hand relaxes. During the clinic visits, participants will use CCFES to assist hand opening during functional training. During participant home sessions, they will use CCFES to perform hand opening exercise.
15871427|NCT03870672|Device|New rTMS approach|Participants in this arm will receive rTMS-based facilitation of the contralesional dorsal premotor cortex (cPMd) located in the non-stroke hemisphere before start of each session. High-frequency rTMS (5-Hz) will be delivered using five 1-min trains of 300 pulses each (total 1500 pulses) for a period of 10 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training + CCFES for a total of one hour. Participants will receive these interventions 2 days a week for 12 weeks.
15871428|NCT03870672|Device|Conventional rTMS approach|Facilitation of M1 will be achieved using 5Hz rTMS. Eight 1-min trains of 300 pulses each will be delivered over a period of 15 min (2400 pulses total).Immediately after the completion of rTMS, participants will undergo upper limb training + CCFES for a total of one hour. Participants will receive these interventions 2 days a week for 12 weeks.
15871429|NCT03870672|Device|Sham rTMS approach|In the sham rTMS group, ipsilesional motor hotspot will be targeted in half the patients and cHMC location will be targeted in the other half (based on random assignment). Immediately after the completion of rTMS, participants will undergo upper limb training + CCFES for a total of one hour. Participants will receive these interventions 2 days a week for 12 weeks.
15871430|NCT03870659|Radiation|Breast MRI|Magnetic resonance imaging to the breast
15871431|NCT03870646|Combination Product|Hypertonic saline of NaCl (7%) in combination with hyaluronic acid|Critical adult tracheostomized patients will receive, in the intervention arm, nebulized Hypertonic saline of NaCl (7%) in combination with hyaluronic acid 5ml twice daily for 10 days from the day of the tracheotomy or until decannulation or discharge from the ICU if it happens before. The treatment will be applied through a jet nebulizer located in the inspiratory branch in patients under mechanical ventilation and in the sole tubulant of patients under T-piece oxygen regimen. Salbutamol 100 micrograms / dose, suspension for inhalation in pressure pack: 2 inhalations through the tracheostomy cannula 10 minutes before the application of the nebulization with hypersaline in order to avoid bronchospasm.
15871432|NCT03870646|Combination Product|Isotonic saline of NaCl (0,9%)|Critical adult tracheostomized patients will receive, in the control arm, nebulized isotonic saline of NaCl (0,9%) 5ml twice daily for 10 days from the day of the tracheotomy or until decannulation or discharge from the ICU if it happens before. The treatment will be applied through a jet nebulizer located in the inspiratory branch in patients under mechanical ventilation and in the sole tubulant of patients under T-piece oxygen regimen. Salbutamol 100 micrograms / dose, suspension for inhalation in pressure pack: 2 inhalations through the tracheostomy cannula 10 minutes before the application of the nebulization with isotonic saline in order to avoid bronchospasm.
15871433|NCT03870633|Other|Medical Chart Review|Undergo medical chart abstraction
15871434|NCT03870633|Other|Interview|Complete telephone interview
15871435|NCT03870633|Other|Questionnaire|Ancillary studies
15871436|NCT03870633|Other|Quality-of-Life Assessment|Ancillary studies
15871437|NCT03870607|Dietary Supplement|prebiotics in combination with probiotics|Administration of prebiotics in combination with probiotics before the start of Ch-RT
15871438|NCT03870594|Diagnostic Test|glycated hemoglobin|hemoglobin A1c level in blood
15871439|NCT03870581|Behavioral|AI-based social software management model|a AI-based miniprogram, embedded in the Wechat social software, to manage participants' warfarin therapy, such as dose adjustment, INR monitoring alert, etc.
15871440|NCT03870581|Behavioral|Human-based social software management model|a Human-based miniprogram, embedded in the Wechat social software, to manage participants' warfarin therapy, such as dose adjustment, INR monitoring alert, etc.
15871441|NCT03870555|Drug|TAK-954|TAK-954 infusion administered intravenously.
15871442|NCT03870555|Drug|TAK-954 Placebo|TAK-954 placebo-matching infusion intravenous.
15871443|NCT03870542|Procedure|kidney transplantation|Kidney transplant for end-stage renal disease from deceased kidney donors
15871444|NCT03870529|Drug|Vitamin A Compound|Participants randomized to this arm will receive 7 consecutive days of of Vitamin A compound without disease progression or unacceptable toxicities. Within 21 days of completion of treatment participants will undergo surgical resection
15871445|NCT03870529|Procedure|Therapeutic Conventional Surgery|Participants randomized to this arm will receive surgical resection
15871446|NCT03870516|Procedure|Mitral valve replacement|Replacing the diseased mitral valve in cases with severe mitral regurgitation with a prosthetic valve.
15871447|NCT03870516|Device|Speckle tracking echocardiography|We will perform Speckle tracking echocardiography in order to identify patients with early subclinical left ventricular or left atrial dysfunction and refer them to surgery, Then after surgery, speckle tracking echocardiography will be performed for all patients to assess improvement of left atrial (conduit, reservoir and booster contractile functions) and left ventricular (global longitudinal strain) function
15871448|NCT03870503|Drug|oxytocin|The patient will be received oxytocin 20 IU by intravenous infusion
15871449|NCT03870503|Drug|oxytocin plus misoprostol|The patient will be received oxytocin 20 IU by intravenous infusion plus 400 mic gm sublingual misoprostol
15871450|NCT03870503|Drug|Carbetocin|The patient received Carbetocin 100 mic gm
15871451|NCT03870490|Drug|VNRX-5133 + cefepime|IV infusion (3 doses)
15871452|NCT03870477|Device|THP Hip Fracture Plating System with telescoping lag screws|The fracture plates are contoured plates used in conjunction with telescoping lag screws that are 7.5mm in diameter with lengths ranging from 70mm to 130mm in 5mm increments.
15871453|NCT03870464|Diagnostic Test|CT-scans extended|CT scans of thorax, abdomen and lower extremities are performed - screening for venous trombolisms at baseline and at 6 months in each patient. If VTE is diagnosed, medications according to guidelines will be administered.
15871454|NCT03870464|Diagnostic Test|MRI scan of the brain|MRI scan of the brain screening for brain metastases. If brain metastases are diagnosed - the possibility of giving radiotherapy along the course of ICI is discussed with the patient. In case of brain metastases consecutive MRI scans of the brain will be performed in order to follow the course (natural or post-radiotherapy) of the disease.
15871455|NCT03870464|Other|Prospective registration of irAEs|irAEs are registered according to Common Terminology Criteria for Adverse Events version 4.0 by a medical doctor or trained experienced clinical nurse.
15871456|NCT03870464|Behavioral|Quality of Life questionnaires|Participants fill out two Quality of Life questionnaires. The European Organization of Research and Treatment of Cancer, Quality of Life -30 questionnaire (EORTC QoL-30) and the European Questionnaire - 5 dimensions-5-level questionnaire (Euro EQ-5D-5L).
15871457|NCT03870451|Device|VascuTherm5 vascular compression device|VascuTherm5 vascular compression unit to function as an intermittent external pneumatic compression device
15871458|NCT03870438|Drug|Lamivudine Oral Solution|In the intervention arm, HIV-1 negative children with HIV-1 positive mothers who have an HIV-1 viral load ≥ 1000 copies/ml will receive lamivudine syrup orally (7.5 mg twice daily if 2 to 4 kg; 25 mg twice a day if weight <8 kg; and 50 mg twice a day if weight >8 kg). The intervention will last a maximum of 10 months (until the baby is 12 months old or until the confirmed end of breastfeeding). Breastfeeding will be considered to be ceased if the mother confirms she is no longer breastfeeding for 2 consecutive monthly visits
15871459|NCT03870425|Other|Distribution pattern of dietary proteins (minced meat)|Study effect of an even or skewed distribution pattern of dietary protein
15871460|NCT03870412|Drug|PEG-rhG-CSF|The test drug PEG-rhG-CSF was administered prophylactically to elderly lymphoma patients who met the inclusion/exclusion criteria 24-72 hours after chemotherapy.
15871461|NCT03870399|Drug|Tamoxifen|The treatment to be used will be tamoxifen 20mg orally once daily.
15871462|NCT03870386|Procedure|EUS-BD with LAMS|Endoscopic ultrasound guided insertion of lumen apposing metal stent forming a choledochoduodenostomy
15871463|NCT03870386|Procedure|ERCP|Endoscopic retrograde cholangiopancreatography to localize and cannulate the bile duct using the guidewire-assisted technique.
15871464|NCT03870373|Device|Pulse Oximeter|Aulisa's non-invasive pulse oximeter sensor is applied to a foot of the neonate; an adhesive patch secures the sensor to the neonate.
15871465|NCT03870360|Behavioral|HOLA Component 1|At week 1 and week 8 participants will meet individually with Community Health Worker (CHW) for 30 minutes for a manualized social and physical activation session.
15871466|NCT03870360|Behavioral|HOLA Component 2|A CHW led 45 minute (10 minutes of stretching and warm up, followed by 30 minutes of walking with a 5 minute cool down) group walk session of six participants at a time done 3 times a week that utilized interval training that slowly gradually increases in intensity.
15871467|NCT03870360|Behavioral|HOLA Component 3|A CHW led pleasant event discussion, asking each participant to identify a pleasant event. This task is done in conjunction with the cool down of HOLA 2.
15871468|NCT03870360|Behavioral|HOLA Component 4|One booster walking session twice a month for six months post intervention for reinforcement, then one booster walking session a month for eighteen months.
15871469|NCT03870360|Behavioral|Healthy lifestyles education program|Biweekly telephone check in calls for the first 16 weeks followed by monthly check in calls during the two year follow up period.
15871470|NCT03870347|Diagnostic Test|Endoscopic ultrasound|Upper endoscopy using an echoendoscope to obtain ultrasound images of the pancreaticobiliary system and adjacent structures.
15871473|NCT03870321|Other|Core training|"In the first week different types of abdominal exercises will be performed: standard, with trunk rotation, extension of the back raising the upper extremity of the body and legs, extension of the back raising one arm and the contralateral leg. In the same way, the subject will raise from the quadruped position one arm and the contralateral leg on each side, and we will ask for the exercise of the front plate, positioning itself in a position of four support points: feet and elbows. When performing the rear bridge exercise the subject will raise the trunk resting on both feet, while in the lateral bridge exercise will be done with support on the right and left side. All exercises will be done for 30 seconds, in 3 series).
~During the next three weeks we will continue with the same training, but for each week we will increase 10 seconds per exercise."
15871474|NCT03870308|Diagnostic Test|Functional MRI|A special type of MRI measuring the metabolic changes that occur within the brain. It may be used to examine the brain's anatomy and determine which parts of the brain are handling critical functions. It helps identify important language and movement control areas in the brain.
15871475|NCT03870295|Diagnostic Test|Sympathetic skin response (SSR) measure|Ankle - ground distance measurement, hand and foot cutaneous temperature reading, low intensity electrical stimulations on hand and on foot to determine SSR at these two points and DN4 questionnaire to assess the possible presence of neuropathic pain
15871476|NCT03870282|Behavioral|Sleep Extension|The intervention is designed to test if sleep tips delivered by text messages can aid with reaching sleep targets. And if additional motivational text messages can further aide with reaching sleep targets.
15871477|NCT03870269|Device|Ceevra Reveal|VR models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source CT/MR image.
15871478|NCT03870256|Drug|misoprostol|Patient receive 600mic gm sublingual misoprostol
15871479|NCT03870256|Drug|Carbetocin|Patient receive 100 mic gm carbetocin IV
15871480|NCT03870256|Drug|TA|The patient receives 1gm oral tranexamic acid
15871483|NCT03870230|Device|Fourier Domain Doppler Optical Coherence Tomography (FDOCT)|Retinal blood flow will be assessed using FDOCT
15871484|NCT03870230|Device|Dynamic Vessel Analyzer (DVA)|Retinal vessel diameters and oxygen saturation will be measured with the DVA device
15871485|NCT03870230|Device|Pattern Electroretinography (pERG)|to assess the neuronal function of the retina, pattern ERG will be performed
15871486|NCT03870230|Device|Optical coherence tomography (OCT)|to assess the morphology of the retina, OCT will be performed
15871487|NCT03870230|Device|Laser Speckle Flowgraphy (LSFG)|to assess retinal blood flow, LSFG will be performed
15871488|NCT03870217|Behavioral|Site selection|Turning off electrodes on the electrode array based on imaging and psychophysical measures
15871489|NCT03870204|Diagnostic Test|POC-CCA rapid urine test|Fresh urine samples will be tested by POC-CCA
15871490|NCT03870191|Other|Injection of either twin block or trigger point injection.|Study participants will be randomized into either group and will receive the intervention.
15871491|NCT03870178|Device|Transcranial direct current stimulation (tDCS)|The noninvasive and nonpharmacological weak electrical current applied to the scalp to modulate cortical excitability.
15871492|NCT03870165|Behavioral|Resistance exercise|Participants will perform leg press and leg extension immediately prior to ingestion of salmon or isolated mixture
15871493|NCT03870165|Other|Salmon|Participants will ingest salmon immediately after resistance exercise
15871494|NCT03870165|Dietary Supplement|Isolated amino acids and fatty acids|Participants will ingest a mixture of isolated amino acids and fatty acids immediately after resistance exercise
15871495|NCT03870152|Procedure|Electrocautery Ablation (EC)|For the purposes of the trial, one round of EC treatment consists of two individual EC treatments with a post-EC AFB in between to check for a response to the 1st EC treatment. Within each round, the second EC treatment will only be administered if the post-treatment AFB confirms presence of persistent high grade disease. Patients in the intervention arm will receive up to three rounds of EC treatment (no more than one round annually) to all their HGLs identified at baseline.
15871585|NCT03869320|Other|Placebo|Matching placebo is available as matching capsules for oral administration, formulated with the same excipients but without ACT-1004-1239.
15871496|NCT03870139|Device|Cerebral stimulation|Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation (NIBS) technique that has been investigated for the management of various health conditions. However, its ergogenic effect still has controversial results.
15871497|NCT03870139|Device|Peripheral stimulation|Peripheral electrical stimulation (PES) activates a complex neural network involving a series of neurotransmitters and receptors capable of promoting segmental and extrasegmental analgesia. Moreover, recent evidence has shown that PES can activate brain motor areas such as primary motor cortex.
15871498|NCT03870126|Other|Flavored beverage|Consume one beverage at the beginning of each visit of the cross-over sequence
15871499|NCT03870113|Biological|Vaccinated group|Develop highly reactive DC vaccines targeting HPV 16/18 E6/ E7 protein and DC vaccine would be injected to patients once a week, six doses in total.
15871500|NCT03870100|Drug|SHR-1222|Pharmaceutical form: water injection Route of administration: subcutaneous
15871501|NCT03870100|Drug|Placebo|Pharmaceutical form: water injection Route of administration: subcutaneous
15871502|NCT03870087|Device|Robotic-assisted PCI|The CorPath GRX is intended for use in the remote delivery and manipulation of guidewires and rapid exchange balloon/stent catheters, and remote manipulation of guide catheters during percutaneous coronary intervention (PCI) procedures.
15871503|NCT03870061|Behavioral|All Babies Are Equal Initiative (conditional cash transfer program)|New Incentives, an NGO, offers cash incentives to caregivers for bringing their child to clinics for the first five visits of the Nigerian Routine Immunization schedule. These small cash transfers can provide some material benefit to new caregivers from poor communities. At a minimum, they help offset time and transport costs. The following vaccines are directly incentivized by the New Incentives' program: tuberculosis (BCG vaccine); diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae Type B (Pentavalent Vaccine), pneumococcal bacteria (PCV vaccine), measles vaccine.
15871504|NCT03870048|Device|transcranial direct current stimulation|A tDCS device (Soterix) will deliver a small direct current through two sponge surface electrodes (5cm × 5cm, soaked with 15 mM NaCL). The positive electrode will be placed over the motor cortex representation of the more affected leg, and a second electrode will be placed on the forehead above the contralateral orbit.
15871505|NCT03870022|Device|Pivot Breath Sensor System|Collect breath sample from the Pivot Breath Sensor to measure the carbon monoxide in the participant's exhaled breath, along with recording responses to user documentation questions and rating scales.
15871506|NCT03870022|Device|Similar Carbon Monoxide breath sensor system|Collect breath sample from a similar breath sensor to measure the carbon monoxide in the participant's exhaled breath.
15871507|NCT03870009|Other|ARDS patients|"The patient will be installed on the scanner bed. Two series of tomographic sections will be acquired: one during an expiratory break, the other during an inspiratory pause.
~cyclic hyperinflation measured by semi-automatic segmentation and by manual segmentation"
15871508|NCT03869996|Procedure|fast track care protocol|fast track care consists in educational preoperative preparation for patients, particular strategies for controlling pain and bleeding and intensive early rehabilitation protocol.
15871509|NCT03869996|Procedure|standard care protocol|standard care protocol consists in the same surgical intervention without educational preoperative preparation for patients and intensive early rehabilitation protocol.
15871510|NCT03869983|Other|Omnipaque™ (iohexol) Injection|755 mg/mL iohexol (350 mgI/mL), 80 mL infused intravenously over approximately 20 seconds
15871511|NCT03869983|Other|CE-Iohexol|755 mg/mL iohexol (350 mgI/mL)/50 mg CAPTISOL®/mL, 80 mL infused intravenously over approximately 20 seconds
15871512|NCT03869970|Behavioral|REST|The REST group will be recommended to return to school and light physical and cognitive activity as soon as tolerated- but no sooner than 48 hrs post-injury per current consensus recommendations. Notifications from the Fitbit app will be turned off, and step goal will be set at 500, to minimize positive feedback and reminders from achievement of activity goals
15871513|NCT03869970|Behavioral|ACTIVITY|ACTIVITY group will be encouraged to engage in light to moderate physical activity with the goal of reaching 10,000 steps a day for one or more days during the first week. Subjects will be encouraged to engage in low-risk activities (e.g. walking). Subjects will be instructed to avoid activities that may increase risk of re-injury (e.g. bike riding, climbing, trampoline, sports). Fitbit notifications will be turned on and step goals will be set at 10,000. The simple goal of reaching 10,000 steps is clear to patients regardless of health literacy level, and real-time feedback provides continuous motivation.
15871514|NCT03869970|Behavioral|mHEALTH|mHEALTH group will be instructed to download the SuperBetter© app. In addition to the pre-programmed general resilience goals, research assistants will help the subjects to set personal mental, social, and emotional rehabilitation goals and milestones for acute recovery from mTBI (e.g. return to school for ½ the day, have an improvement in symptoms). These goals/milestones will give the patient an opportunity to celebrate the achievement of improvement from mTBI with the goal of generating a positive contextual frame for recovery.
15871515|NCT03869957|Dietary Supplement|Intervention group|0.1-0.2 g n-3 PUFA/kg body weight/day for 7 days
15871516|NCT03869944|Drug|Lamivudine Oral Solution|"During the EPI-2 visit, HIV-1 negative children of mothers with a unsuppressed plasma HIV-1 VL (≥ 1000 copies/mL) will be initiated on PrEP, lamivudine syrup (7.5 mg twice daily if 2 to 4 kg; 25 mg twice a day if weight <8 kg; and 50 mg twice a day if weight >8 kg) for 10 months, until the child is 12 months old. A monitoring on the mother's VL and child's diagnosis will take place at 6 and 12 months.
~Mothers with unsuppressed plasma HIV-1 VL (< 1000 copies/mL) and HIV-1 negative children will not be offered PrEP but the mother's VL and child diagnosis will be monitored at 6 and 12 months: If the VL is ≥ 1000 copies/mL, the child will be initiated on PrEP until the child is 12 months old.
~Children infected with HIV-1 will be referred to the National Program for immediate ART."
15871517|NCT03869931|Drug|Fenofibrate|Fenofibrate 100 mg or 300 mg (according to CrCl)
15871518|NCT03869918|Other|Exercise Program|Exercise at home or through a class as chosen by the subject.
15871519|NCT03869905|Drug|Aquamin®|4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day)
15871520|NCT03869905|Drug|Placebo first then Aquamin®|4 capsules per day; 2 to be taken in the morning and 2 in the evening
15871550|NCT03869671|Behavioral|Harm reduction standard of care|Participants will be provided with harm reduction supplies and health information and counseling according to routine practice at the community-based setting (harm reduction organization).
15871521|NCT03869892|Drug|Trifluridine/tipiracil hydrochloride (S95005)|Film-coated tablets of S 95005 (35 mg/m²/dose) will be administered orally twice a day (BID), within 1 hour after completion of morning and evening meals, 5 days on/2 days off, over 2 weeks, followed by a 14-day rest; This treatment cycle will be repeated every 4 weeks.
15871522|NCT03869892|Drug|Capecitabine|Film-coated tablets, Capecitabine (1250 mg/m²/dose) will be administered orally BID on Days 1-14 of each cycle. This treatment cycle will be repeated every 3 weeks.
15871523|NCT03869892|Biological|Bevacizumab experimental|Concentrate for solution for infusion, Bevacizumab (5 mg/kg, IV) administered every 2 weeks (Day 1 and Day 15). This treatment cycle will be repeated every 4 weeks.
15871524|NCT03869892|Biological|Bevacizumab control|Concentrate for solution for infusion, Bevacizumab (7.5 mg/kg, IV) will be administered on Day 1 of each cycle.This treatment cycle will be repeated every 3 weeks.
15871525|NCT03869879|Other|Feedback-assisted physical therapy|The system uses unobtrusive, wearable, inertial sensors with real-time algorithms to provide real-time feedback on: step time asymmetry, foot clearance, arm swing, trunk lateral range, and foot strike angle during gait.
15871526|NCT03869879|Other|Traditional physical therapy|Therapists will treat these patients with traditional therapeutic modalities and practices.
15871527|NCT03869866|Biological|Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine MenACYW conjugate vaccine|Pharmaceutical form: Solution for injection Route of administration: Intramuscular
15871528|NCT03869853|Behavioral|Entrepreneurial stimulation and integrated education|one month cycle of stimulation of business with integrated education on nutrition, health, and gender empowerment
15871529|NCT03869853|Behavioral|control|no intervention
15871530|NCT03869840|Device|Sensor to spot check blood levels|Sensor to check blood levels, not used as intervention
15871531|NCT03869827|Other|necrotizing enterocolitis|Collection of necrotizing enterocolitis diagnosis, as well as its severity, are based on the classification of Belle modified in 3 stages: 1) Suspected, 2) Proven, 3) Advanced
15871532|NCT03869814|Diagnostic Test|Non-invasive Liquid Biospy|Non-invasive Liquid Biospy
15871533|NCT03869801|Procedure|erector spinae plane block|Ultrasound-guided bilateral Erector spinae plane (ESP) block performed before the surgery. Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed.
15871534|NCT03869801|Procedure|quadratus lumborum block|Ultrasound-guided bilateral Quadratus lumborum (QLB) type 2 block performed before the surgery. Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed.
15871535|NCT03869775|Device|perfusion index monitor|perfusion index measured in patients undergoing spinal anesthesia with non-invasive perfusion index monitor
15871536|NCT03869775|Diagnostic Test|ewing test|ewing tests will be applied to diabetic patients undergoing spinal anesthesia for cardıovascular autonomous neuropathıa diagnosis
15871537|NCT03869762|Drug|Xgeva|Denosumab is a human monoclonal antibody (IgG2) that targets and binds with high affinity and specificity to RANKL, preventing the RANKL/RANK interaction from occurring and resulting in reduced osteoclast numbers and function, thereby decreasing bone resorption and cancer induced bone destruction.
15871538|NCT03869762|Drug|Xtandi|"Enzalutamide is a potent androgen receptor signalling inhibitor that blocks several steps in the androgen receptor signalling pathway. Enzalutamide competitively inhibits binding of androgens to androgen receptors, inhibits nuclear translocation of activated receptors and inhibits the association of the activated androgen receptor with DNA even in the setting of androgen receptor overexpression and in prostate cancer cells resistant to anti-androgens.
~Enzalutamide treatment decreases the growth of prostate cancer cells and can induce cancer cell death and tumour regression."
15871539|NCT03869749|Behavioral|Learning to BREATHE Plus|Activities include psycho-education about stress and emotion regulation, and practices of body scanning, non-aerobic yoga, and meditation, which are designed to cultivate and provide opportunities to practice present-focused, non-judgmental attention.
15871540|NCT03869749|Behavioral|Health and wellness|The Health Education Wellness Program (modeled after Hey Durham) (Bravender, 2005) will provide didactic information on substance use, nutrition/body image, stress management, exercise, and signs of depression/suicide.
15871541|NCT03869736|Drug|Nitrous Oxide|1-hour sessions of inhaled nitrous oxide at concentrations of 25% or 50% (randomly assigned) to be administered weekly for 4 weeks.
15871542|NCT03869736|Drug|Placebo|1-hour sessions of inhaled oxygen-air mixture (inspired oxygen concentration ~23-30%) to be administered weekly for 4 weeks.
15871543|NCT03869723|Procedure|Virtual planning using customized surgical devices|Preoperative modeling was conducted by obtaining scans of patient maxillofacial skeleton and angioscans of the lower extremities. The planning phase was then carried out by the surgeon and the engineer (from MATERIALISE, Leuven, Belgium) so as to define the clinical and technical parameters of the reconstruction. This stage consisted of discussing and determining osteotomy lines, donor side, anastomosis site, and overall reconstruction contour. Resection was decided by the surgeon. 3D modeling and the manufacture of cutting guides and customized osteosynthesis plates were then undertaken
15871544|NCT03869723|Procedure|Conventional surgery|Classical surgery for mandibular reconstruction with fibula free flap
15871545|NCT03869710|Device|Ultrasound-guided Dry-Needling Therapy|The needle will be insert under ultrasound guidance to elicit the myofascial response on the neck of the patients
15871546|NCT03869697|Drug|SCB-313|5 mg or 20 mg lyophilized powder in a single-use glass vial
15871547|NCT03869684|Drug|MT-0814|Randomly assigned dose
15871548|NCT03869684|Drug|Placebo|Placebo manufactured to mimic MT-0814
15871549|NCT03869671|Behavioral|PrEP uptake/adherence intervention|The interventionist will follow the manual to deliver informational and motivational strategies to participants to enhance their PrEP uptake (including completing clinical screening and obtaining/filling a PrEP prescription) and adherence (taking daily oral PrEP doses). The interventionist will assist participants in problem-solving around topics including limited transportation options, identifying local pharmacies, storing medications given complex living arrangements, coping with side effects, communicating with providers and pharmacists, and maintaining daily medication schedules with reminders and cues.
15871551|NCT03869658|Behavioral|COCO application|All participants will complete a screening survey to determine their eligibility for the study, if eligible and willing to participate, he or she will sign an informed consent form. Once participants are enrolled in the study, a demographics questionnaire will be completed along with 5 days of food tracking on the COCO application. Between days 3 and 7, participants will complete two 24-hr diet recall, one a day, and a patient satisfaction questionnaire.
15871552|NCT03869645|Device|CAPERE Thrombectomy System|Mechanical thrombectomy of acute thrombus in peripheral vasculature with the CAPERE Thrombectomy System
15871553|NCT03869632|Drug|YL-13027|Daily doses by oral administration on each day of each 28 day cycle. Starting dose is 60mg, with escalation to 360mg, and subsequent dose escalation using a modified Fibonacci algorithm.
15871554|NCT03869619|Other|Real-life epidemiological platform of lymphoma in France|"The REALYSA database will be described with the following characteristics:
~Number of patients included per month in total and according to subtype of lymphoma
~Number of patients in each region in total and according to subtype of lymphoma"
15871555|NCT03869606|Device|NICOM by Cheetah Medical|Observational measurement, Cardiac Output, Pre- and Post Anesthesia
15871556|NCT03869593|Genetic|Sample analysis|Here, to determine the importance of the mutation we will analyze the blood content of patients presenting E. coli and S. aureus bacteremia
15871557|NCT03869567|Device|cone beam CT|Just after thrombectomy, a cone beam CT will be done, while patient is on angiography table, in order to determine if hemorrhage image is due to contrast accumulation or blood-brain barrier disruption.
15871558|NCT03869554|Diagnostic Test|Detection of Fabry disease|Systematic detection of Fabry disease
15871559|NCT03869541|Other|Mobilization|Physical rehabilitation
15871560|NCT03869528|Drug|5 sprays of 10% lignocaine|5 sprays of 10% lignocaine
15871561|NCT03869528|Drug|10 sprays of 10% lignocaine|10 sprays of 10% lignocaine
15871563|NCT03869489|Device|Anodal left dorsolateral prefrontal cortex tDCS stimulation|Anodal tDCS will be applied to the left dorsolateral prefrontal cortex of participants
15871564|NCT03869489|Device|Anodal right dorsolateral prefrontal cortex tDCS stimulation|Anodal tDCS will be applied to the right dorsolateral prefrontal cortex of participants
15871565|NCT03869489|Device|Sham tDCS stimulation|Sham tDCS stimulation will be applied
15871566|NCT03869476|Diagnostic Test|Non-invasive diagnosis score|"spleen fibrosis by elastography
~plasma cytokines levels
~mutationnal landscape by NGS
~CD34 circulating cells"
15871567|NCT03869463|Other|Computerized Cognitive Training|Participants will complete 8 weeks of computerized cognitive training through the Peak platform on mobile devices.
15871568|NCT03869463|Other|Control|This group will not receive computerized cognitive training.
15871569|NCT03869450|Device|Restylane Volyme|Hyaluronic based filler
15871570|NCT03869450|Device|Restylane Defyne|Hyaluronic based filler
15871571|NCT03869450|Device|Restylane Lyft Lidocaine|Hyaluronic based filler
15871572|NCT03869437|Drug|Cefiderocol|2 g intravenously over 3 hours every 8 hours for a period of 7 to 14 days (dosage adjustment is necessary based on renal function).
15871573|NCT03869437|Other|Best Available Therapy|Standard of care was determined by the investigator
15871574|NCT03869424|Other|Active Placebo labelled as antidepessant|Participants receive an active nasal spray that is in fact a placebo.
15871575|NCT03869411|Behavioral|supervised aerobic exercise or home-based aerobic exercise|"The aerobic exercise and home exercise programs are consisted of 50 minutes per time, 3 times per weeks and totally 3 months.
~The aerobic exercise group will perform the exercise program under one physical therapy and one aerobic dance teacher supervised. The home exercise group will do the exercise program based on ACSM's aerobic exercise recommend, and will used the home exercise record form to make sure their cooperation."
15871576|NCT03869398|Dietary Supplement|Tums|start their calcitriol 0.25mcg PO BID and Tums 1,500mg PO TID 5 days before surgery. The five days is determined due to the time it takes vitamin D to have an effect on the guts reabsorption of calcium.
15871577|NCT03869398|Dietary Supplement|Calcitriol|start their calcitriol 0.25mcg PO BID and Tums 1,500mg PO TID 5 days before surgery. The five days is determined due to the time it takes vitamin D to have an effect on the guts reabsorption of calcium.
15871578|NCT03869385|Drug|Albutein® 200 g/L or Plasbumin® 20|The initial dose of the trial drug must be started within 6 to 24 hours after the beginning of the septic shock. Starting dose: 60 g human albumin 20% (Albutein® 200 g/L, infusion solution) over 2-3 h Daily administration of the trial drug will be based on the serum albumin concentration measured each day. Dose adjustment will follow a predetermined schedule with the aim of maintaining a serum albumin concentration of at least 30 g/l. Administration of the trial drug will continue for a maximum of 28 study days after randomisation and only as long as the participant is being treated in the ICU.
15871579|NCT03869372|Device|rTMS|In subsequent sessions, the same measures of autonomic activity and MEPs will be monitored but different patterns of repetitive TMS (rTMS) will be applied to motor cortex or other areas before the test meal, water or nutrient drink is consumed.
15871580|NCT03869359|Other|Gluten-free diet with gluten powder|The subjects will sprinkle gluten powder over their meals, twice a day. (14 g/day vital gluten: Real Foods, Edinburgh, United Kingdom). Plastic sachet marked with B (WePack, Derbyshire, United Kingdom). Free of fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs).
15871581|NCT03869359|Other|Gluten-free diet with placebo powder|The subjects will sprinkle placebo powder over their meals, twice a day. (14 g/day rice starch: Doves Farm Foods Ltd., Berkshire, United Kingdom) Plastic sachets marked with A (WePack, Derbyshire, United Kingdom). Low in fermentable oligosaccharides, disaccharides, monosaccharides and polyols (FODMAPs).
15871582|NCT03869333|Biological|Invaplex[AR-DETOX]|Detoxified Shigella flexneri 2a Artificial Invasin Complex (Invaplex[AR-Detox]) Vaccine
15871583|NCT03869333|Other|Placebo|Saline
15871584|NCT03869320|Drug|ACT-1004-1239|ACT-1004-1239 will be available for clinical study use as hard gelatin capsules for oral administration formulated in strengths of 1, 10, and 100 mg. For the ADME subpart, a single oral dose of 1 μCi of 14C radiolabeled ACT-1004-1239 will be given simultaneously with the ACT-1004-1239 capsule. For the absolute bioavailability subpart, a single intravenous dose of a maximum of 1 μCi of 14C radiolabeled ACT-1004-1239 will be given at the expected tmax after the administration of the ACT-1004-1239 capsule.
15871586|NCT03869320|Drug|ACT-1004-1239 (Food-effect subpart)|ACT-1004-1239 will be available for clinical study use as hard gelatin capsules for oral administration formulated in strengths of 1, 10, and 100 mg.
15871587|NCT03869320|Other|Placebo (Food-effect subpart)|Matching placebo is available as matching capsules for oral administration, formulated with the same excipients but without ACT-1004-1239.
15871588|NCT03869307|Other|Exercise|The exercise programme includes exercises identified in literature to target scapular and rotator cuff muscles.
15871589|NCT03869294|Drug|GS|Gemcitabine plus S-1 (GS) was used to treat advanced pancreatic cancer
15871590|NCT03869281|Procedure|Pancreas transplantation alone|Pancreas transplantation
15871591|NCT03869268|Drug|Aspirin|Aspirin will be allocated in different doses and will be used in conjunction with ticagrelor depending on the arm of the trial the participant is randomised to. The different doses are as follows: 20 mg, 75 mg and 300 mg.
15871592|NCT03869268|Drug|Ticagrelor|Ticagrelor will be allocated as a single loading dose of 180 mg (2 x 90 mg orodispersible tablets) and will be used in conjunction with aspirin depending on the arm of the trial the participant is randomised to.
15871593|NCT03869255|Procedure|Nasal swab|In hospitalized patiens, a nasal swab will be performed within the first 48 hours and on the 7th day. In community patient, only one swab will be performed
15871594|NCT03869242|Device|NovoTTF-200A|newly diagnosed GBM patients treated with NovoTTF-200A concomitant to RT and TMZ.
15871595|NCT03869229|Biological|Intra-articular injection of ADMSC|Intervention: Intra-articular injection of Adipose-derived Mesenchymal Stem Cells (ADMSC)- ultrasound guided intra-articular injection of at least 10 million of ADMCS per procedure, maximum four procedures (i.e. injections per joint), minimum number of cells pre protocol 40 million
15871597|NCT03869203|Other|Enhanced recovery after surgery (ERAS)|The patients in the ERAS group were given a pre-treatment drug [300 mg (gabapentin, Neurontin 300mg) and 10 mg oxycontin (oxycontin, Oxycontin CR 10mg) and 2 mg prednisolone (prednisolone 10 mg, Solondo 5mg)] on the evening before surgery. And pre-operative fasting should not exceed 6 hours, and clear liquid fasting should not exceed 2 hours. In addition, 400 ml of oral carbohydrate should be taken 2 to 4 hours before surgery to ensure adequate blood sugar and encourage regular diet (light meal) as soon as possible within a tolerable range after surgery. The initial pain after surgery is actively controlled by oral drugs such as celebrex and IR codon, and injections such as tramadol and demerol. On the first postoperative day, the urinary catheter is removed and CPM (continuous passive motion) rehabilitation is started.
15871607|NCT03869177|Other|Implementation support program|"The IFIP intervention consists of the following elements:
~I. Clinical interventions 1.1 A basic level of family involvement and support 1.2 Family psychoeducation in single-family groups
~II. Implementation interventions 2.1 Training and guidance of health care personnel 2.2 A family coordinator 2.3 Other implementation measures"
15871608|NCT03869164|Device|ValveClamp|ValveClamp is an easy-to-operate transcatheter edge-to-edge mitral valve repair system with larger coaptation width
15871609|NCT03869151|Diagnostic Test|CBC|lymphocyte and monocyte count
15871610|NCT03869138|Behavioral|Virtual-reality based dance training|"Participants will receive therapy using the Just Dance using the commercially available Kinect gaming system (Microsoft Inc, Redmond, WA, USA. Each song involves repetitive action for each dance step (at least 20 repetitions over the entire song) and visual cues on the screen (a stick figure at the bottom right) indicating the upcoming dance step. Participant's playing the game to reduce risk of exercise related adverse effects. Participants will dance on 10 songs starting from a slow-pace progressing to a medium pace (each max 5 minutes long). Participants will receive 5 minutes rest after playing on each song. This will be conducted by two physical therapists."
15871611|NCT03869125|Diagnostic Test|Blood pressure measurement|Blood pressure monitoring using automated office blood pressure measurement (AOBPM), office blood pressure measurement (OBPM), and 24-hour ambulatory blood pressure monitoring
15871612|NCT03869112|Behavioral|Physical activity intervention|Physical activity group will be given a charge 2 FitBit device to monitor their PA specially steps count, step targets will be discussed with the participants with a view to increasing their daily physical activity over the 6 week period. A recent protocol has been described that encouraged an increase of 500 steps weekly. This was well tolerated by participants (Demeyer, Louvaris et al. 2017). This will be an unsupervised, home-based intervention.
15871613|NCT03869112|Other|Pulmonary rehabilitation group|Pulmonary rehabilitation group is a 6-week intervention of supervised exercise and group education and will follow the BTS guidelines. (Bolton, Bevan-Smith et al. 2013)
15871614|NCT03869099|Other|Pneumonia Case Management Practices|Standard practices of pneumonia case management at three levels of health care; community level, first level care facility and practitioner level, across Pakistan.
15871615|NCT03869086|Other|Freeze dried blueberry powder|36 g of freeze-dried blueberry powder to be mixed with milk and served together with an energy-dense meal.
15871616|NCT03869086|Other|Anthocyanin free, sugar-matched placebo|36 g of isocaloric placebo, matched for sugars to be mixed with milk and served together with an energy-dense meal.
15871617|NCT03869073|Drug|Evolocumab|Three pre-filled shrouded syringes for subcutaneous injection in abdomen.
15871618|NCT03869073|Drug|Placebo|Preservative free 0.9% sodium chloride. Three pre-filled shrouded syringes for subcutaneous injection in abdomen.
15871619|NCT03869060|Biological|Dengue-1 Virus-Live Virus Human Challenge (DENV-1-LVHC)|Dengue subtype 1 Challenge Virus (DENV-1) strain 45AZ5
15871620|NCT03869047|Drug|Dexmedetomidine +bupivacaine|patients will receive combined general anesthesia and Quadratuslumborum block( transincisional ie before wound closure)with 19 mL of bupivacaine 0.20%plus 1 mic/kg of dexmedetomidine, total volume 20 ml
15871621|NCT03869047|Drug|Bupivacaine|patients will receive combined general anesthesia and quadratus lumborum block (transincisional) with 20 ml of bupivacaine 0.20% .
15871622|NCT03869034|Combination Product|TAI+PD1|Patients receive Sintilimab on the first day of TAI+PD1 treatment. On the day 2-3 during the same hospitalization, the FOLFOX chemotherapy regimen of TAI is perform for 48 hours continuous infusion. The TAI+PD1 treatment repeats every 3 weeks, and the hematological parameters are reviewed before the start of each course of TAI+PD1 treatment. Those who meet the inclusion criteria can be prescribed according to the plan. Patients with G2 toxicity have to delay the planned treatment until the toxicity is reduced to G1. If the toxicity does not return to a state in which treatment can be continued after 2 weeks of active treatment, the treatment need suspended for safety.
15871623|NCT03869034|Combination Product|TAI with FOLFOX|The FOLFOX chemotherapy regimen of TAI is perform for 48 hours continuous infusion. The TAI+PD1 treatment repeats every 3 weeks, and the hematological parameters are reviewed before the start of each course of TAI+PD1 treatment. Those who meet the inclusion criteria can be prescribed according to the plan. Patients with G2 toxicity have to delay the planned treatment until the toxicity is reduced to G1. If the toxicity does not return to a state in which treatment can be continued after 2 weeks of active treatment, the treatment need suspended for safety.
15871624|NCT03869021|Other|3D printed surgical guide constructed|A printed surgical guide ( to direct through the surgery and make results predictable), the guide is designed by Mimics 19.0, Materialise NV,Belgium and printed with self cure resin
15871625|NCT03869021|Other|free hand surgery|A control group in which patients are randomly assigned and surgeries are planned without surgical guides and performed free handed
15871626|NCT03869008|Device|gammaCore Sapphire|"gammaCore SapphireTM (non-invasive vagus nerve stimulator) is intended to provide non-invasive vagus nerve stimulation (nVNS) on the side of the neck. gammaCore provides a mild electrical stimulation to the vagus nerve, which runs through the neck and carries information to the central nervous system.
~Subjects will be instructed to use the gammaCore Sapphire to stimulate 2 minutes on each side of the neck, twice a day, every day. The subject controls the intensity level of the electrical stimulation."
15871627|NCT03869008|Device|Sham Device|The Sham device delivers no electrical stimulations but subjects randomized to the Sham device will received the same instructions to use the Sham device to stimulate 2 minutes on each side of the neck, twice a day, every day for the first 4 weeks after randomization.
15871628|NCT03868995|Procedure|Sham injection|Dextrose water injection to subcutaneous layer at tender point
15871629|NCT03868995|Procedure|Tendon injection|Dextrose water injection to injured tendon
15871630|NCT03868982|Device|Neurally adjusted ventilatory assist|NAVA uses the diaphragm activity to deliver mechanical ventilation
15871631|NCT03868969|Drug|Fosfomycin Oral Suspension|Man with urinary tract infections with BLSE enterobacteriaceae will be treated by fosfomycin 1 packet by day for 21 days
15871632|NCT03868956|Diagnostic Test|Colour doppler ultrasound with or without D-dimer test|"Positive CDUS: anticoagulant treatment
~Negative CDUS: no anticoagulant treatment
~Non diagnostic CDUS : reference to routine D-dimer test
~Negative test : no anticoagulant treatment
~Positive test : second CDUS 7 days (±2) after first one
~No change in CDUS : no anticoagulant treatment
~Change in CDUS : anticoagulant treatment"
15871633|NCT03868943|Drug|Soliramfetol|Solriamfetol will be dosed by flexible dose titration starting at 75 mg daily in all patients and escalating after 7 days (1 week) to 150 mg daily and then after 7 days to 300 mg daily for a total duration of 3 weeks (flexible dose titration period).
15871634|NCT03868930|Behavioral|STEP-Home|This group will meet for 2 hours a week for 12 weeks. The core skills of Emotional Regulation (ER) (45-minutes) and Problem Solving (PS) (45-minutes) are introduced and then integrated throughout all Veteran-specific content modules for practice and repetition for 12 weeks. Attention Training (AT) augments PS and ER core skills and is interspersed throughout group and individual sessions.
15871635|NCT03868930|Behavioral|PCGT|The PCGT group will also meet for 2 hours a week for 12 weeks. It is a nonspecific and supportive intervention to control for the nonspecific benefits of the group experience (e.g., therapist contact, instillation of hope, expectation of improvement). It will focus on identifying and discussing current life stressors that contribute to reintegration difficulties, psychoeducation, and promotion of wellness and physical health.
15871636|NCT03868917|Procedure|thoracic paravertebral block using pressure measurement technique|The continuous thoracic paravertebral block using ultrasound machine is combined with pressure measurement during needle advancement.
15871637|NCT03868904|Device|OCS Lung System|No active interventions are part of this study. This study will collect long-term survival and BOS data in subjects who were part of the INSPIRE trial.
15871638|NCT03868891|Device|EMST150|The EMST150 consists of a handheld plastic tube with a mouthpiece on one end and an adjustable valve on the other end. Your child will close his/her lips around the mouthpiece and breathe out against resistance. The EMST150 will be adjusted to the point where airflow stops. Each day, your child will blow into the EMST150 5 sets of 5 times with a 10-15 second rest between each use and a 1-2 minute rest between each set of 5. You will adjust the resistance of the device each week, take a picture of the device settings, and document exercise sets performed in an exercise diary. These exercises will be performed twice in each nostril 2 times a day until your child's next visit at the MEPL (at least 8 weeks). Each session should take approximately 10-15 minutes, for a total of 30 minutes per day.
15871639|NCT03868878|Other|Capoeira training|The Capoeira training protocol, based in the modern styles was applied by an instructor with 16 years of experience. The protocol followed the directions of the ABADÁ Capoeira system, being adapted to the sample of older adults of the present study. The experimental protocol for Capoeira progressive training program lasted 12 weeks and was performed twice a week with duration of 60 minutes each. Each session was divided in three parts, being: 1) initial part: consisting of 10 minutes warm-up with recreational activities at low intensity; 2) main part: consisting of 30 minutes of basic movements in the modality and; 3) final part: consisting of 20 minutes with theoretical instructions related to Capoeira and musicality (singing and touch of typical instruments). In order to perform the Capoeira progressive training program, the technical improvement naturally occurred every week, resulting in a higher speed in movements execution and thus to a gradual increase in training intensity.
15871640|NCT03868865|Behavioral|Integrative mind-body-medicine group program|The mind-body-medicine group program focuses on support in coping with the disease, in lifestyle modification and in reduction of chemotherapy induced side effects. The self-contained modules of the mind-body-medicine group program can be followed in an individual order, to allow adoption to different chemotherapy concepts and continued access is possible. Patients can join in the group program eleven times for six hours each visit. They participate in every one of the eleven modules once.
15871641|NCT03868852|Drug|Apatinib mesylate tablets|Apatinib mesylate tablets were orally administered 250 mg QD from 1 week before radiotherapy to the whole radiotherapy period. (Appatinib is no longer used after radiotherapy)
15871642|NCT03868852|Radiation|Three-dimensional conformal intensity modulation|Three-dimensional conformal intensity modulation (IMRT) technique was used for post-operative radiotherapy. The radiation dose was 45-54 Gy.
15871643|NCT03868839|Drug|Telmisartan Pill|telmisartan 40mg once a day during week 1; the dose will be increased to 80mg (target dose) or as tolerated during the remaining three weeks.
15871644|NCT03868826|Procedure|Orthopaedic surgery and/or rehabilitation|The avulsion is repaired and hereafter the patient follows rehabilitation. Some are treated conservatively and only follow rehabilitation.
15871645|NCT03868813|Behavioral|Semi-structured Interview|One-on-one semi-structured interviews
15871646|NCT03868800|Other|SDM-DC|The SDM-DC intervention is designed for patients with kidney failure who must make a decision regarding type of dialysis: haemodialysis or peritoneal dialysis. SDM-DC consists of patient and his or her relative(s) being given a patient decision aid called 'Dialysis choice' and booked for meetings with a dialysis coordinator. There were optional videos describing other patients' experiences making this decision. The dialysis coordinators were trained in the why, what and how in relation to SDM-DC and to deliver the intervention by tailoring to patients' needs and using three different communication skills: mirroring, active listening and value clarification.
15871647|NCT03868787|Device|TENS|TENS units are small, inexpensive, portable, battery-powered devices which deliver mild, alternating electrical currents via electrodes positioned on the skin near the anticipated dermatomal distribution of pain.
15871648|NCT03868787|Device|Sham TENS|Non-active TENS unit
15871649|NCT03868774|Procedure|repetitive transcranial magnetic stimulation|rTMS is a new non-invasive antidepressant method, which implies non-convulsive focal stimulation of the prefrontal cortex of the brain through a time varying magnetic field.
15871650|NCT03868761|Behavioral|Sonoma Rises|All participants will receive the intervention, Sonoma Rises, a mobile app designed by psychologists at the National Center for PTSD for wildfire survivors to facilitate recovery from disaster. Users can access evidence-informed tools to help cope with stress, heal from loss, prioritize self-care, connect with others, manage anger, and track their mood using validated assessments. There are also tools designed just for teens and users are linked to psychoeducation on disaster and health and other mental health resources and services.
15871651|NCT03868748|Dietary Supplement|Beta-arbutin|Beta-arbutin capsules
15871652|NCT03868748|Other|Placebo|Placebo capsules containing non-medicinal ingredients
15871653|NCT03868735|Device|CleanSweep Closed Suction System|Device with balloon sweeping technology
15871654|NCT03868722|Drug|Acalabrutinib|Acalabrutinib 100 mg BID from cycle 1 day 1 for 3 cycles of 28 days.
15871655|NCT03868722|Drug|Venetoclax|Venetoclax, ramp up during the first five weeks starting cycle 1 day 1, 7 days treatment on each dose level (20-50-100-200-400 mg), thereafter 400 mg once daily for a total of 3 cycles of 28 days.
15871656|NCT03868709|Drug|Penehyclidine inhalation|Penehyclidine inhalation is administered by inhalation (penehyclidine hydrochloride 0.5 mg/0.5 ml, mixed with normal saline 5.5 ml) once every 12 hours from the night before surgery till the second day after surgery. The total number of inhalation is seven times. Study drug inhalation is performed with the high-flow oxygen-driven method for the non-intubated patients or with the atomizing inhalation device of ventilator for the intubated patients
15871657|NCT03868709|Drug|Placebo inhalation|Placebo inhalation is administered by inhalation (water for injection 0.5 ml, mixed with normal saline 5.5 ml) once every 12 hours from the night before surgery till the second day after surgery. The total number of inhalation is seven times. Study drug inhalation is performed with the high-flow oxygendriven method for the non-intubated patients or with the atomizing inhalation device of ventilator for the intubated patients.
15871658|NCT03868696|Procedure|MUA with sham ultrasound|Standard MUA with sham ultrasound
15871659|NCT03868696|Procedure|MUA with active ultrasound|Standard MUA guided by ultrasound
15871660|NCT03868683|Other|Glucose Reference 1|30 g of glucose dissolved in 250 ml of water
15871661|NCT03868683|Other|Glucose Reference 2|30 g of glucose dissolved in 250 ml of water
15871662|NCT03868683|Other|Glucose reference 3|30 g of glucose dissolved in 250 ml of water
15871663|NCT03868683|Other|Sucrose|30 g of Sucrose dissolved in 250 ml of water
15871664|NCT03868683|Other|Regular Bake beans in tomato sauce|Bake beans in tomato sauce containing 14 g of sugar
15871665|NCT03868683|Other|Bake beans in tomato sauce, reduced sugar|Bake beans in tomato sauce containing 12.2 g of sugar
15871666|NCT03868683|Other|Bake beans in tomato sauce, low GI|Bake beans in tomato sauce containing 7.2 g of sugar
15871733|NCT03868098|Drug|Crisaborole 2%|Crisaborole ointment 2% (application rate A, B, C) for 15 days (double blind)
15871734|NCT03868098|Drug|Placebo ointment|Placebo ointment (vehicle)
15871735|NCT03868085|Diagnostic Test|dual energy x-ray absorptiometry|DXA scan
15871736|NCT03868072|Drug|XELJANZ 5Mg Tablet|XELJANZ 5Mg Tablet 1T single oral administration under fasting
15871667|NCT03868670|Device|responsive neurostimulation|The RNS® System is a novel, implantable therapeutic device that delivers responsive neurostimulation, an advanced technology designed to continuously monitor brain electrical activity, detect abnormal electrical activity and respond by delivering imperceptible levels of electrical stimulation to normalize that activity before an individual experiences seizures. This is an Early Feasibility Study determining the safety and efficacy of NAc-RNS in the treatment of LOC eating in treatment-refractory obesity.
15871668|NCT03868657|Drug|Moxifloxacin|Moxifloxacin is solely used to cause a known and for the drug well documented effect, namely blockade of the Kv11.1 channel.
15871669|NCT03868657|Drug|Placebo|Placebo
15871670|NCT03868644|Behavioral|Voluntary Counseling and Testing for HIV (VCT)|Youth are offered VCT conducted onsite via mobile clinics in accordance with Kenya National HIV Testing Guidelines by certified VCT counselors trained by the National AIDS and STI Control Program (NASCOP).
15871671|NCT03868644|Behavioral|Condoms|Youth are offered 50 packages containing 3 condoms each of Trust brand condoms free of charge.
15871672|NCT03868631|Dietary Supplement|Whey protein supplement|19 g whey protein isolate (contains 2 g leucine) was consumed daily by one intervention group.
15871673|NCT03868631|Dietary Supplement|Soy protein supplement|26 g soy protein isolate (contains 2 g leucine) was consumed daily by the other intervention group.
15871674|NCT03868618|Device|Genio™ system|The Genio™ device is a permanent implant. It is implanted in the chin area and delivers stimulation to both hypoglossal nerve branches (i.e., the left and right branches). The implant does not include a battery or an embedded software and is externally powered.
15871675|NCT03868605|Device|EMR and ESD|Endoscopic mucosal resection using a resection snare Endoscopic submucosal dissection using an electrosurgical knife
15871676|NCT03868605|Device|Over- the- scope full- thickness resection device|Endoscopic resection of neoplastic lesions of the colon using the over- the- scope full- thickness resection device
15871677|NCT03868592|Procedure|Gastric sleeve/bariatric surgery|weight loss
15871678|NCT03868579|Procedure|Biopsy|Undergo biopsy
15871679|NCT03868579|Other|Medical Chart Review|Review medical chart
15871680|NCT03868579|Procedure|Thoracoscopy|Undergo pleuroscopy
15871681|NCT03868566|Drug|SNP-612 dose1|Subjects will take dose1 once a day orally for 12 weeks
15871682|NCT03868566|Drug|SNP-612 dose2|Subjects will take dose2 once a day orally for 12 weeks
15871683|NCT03868566|Drug|SNP-612 dose3|Subjects will take dose3 once a day orally for 12 weeks
15871684|NCT03868566|Drug|SNP-612 placebo|Subjects will take placebo once a day orally for 12 weeks
15871685|NCT03868553|Other|No intervention|observational study
15871686|NCT03868540|Drug|BI 1291583|tablet
15871687|NCT03868540|Drug|Placebo|tablet
15871688|NCT03868527|Other|Data collection|Data collection for biostatistical analysis about hematological diseases
15871689|NCT03868514|Device|TiLOOP® Bra Pocket|Primary or secondary breast reconstruction following mastectomy with titanised polypropylene mesh TiLOOP® Bra Pocket
15871690|NCT03868501|Behavioral|n-back task|All participants will be asked to finish the 3-back task and the 1-back task. The 3-back task and the 1-back task will be carried out at intervals to avoid the influence between different tasks. The sequence of the 3-back task and the 1-back task will be counterbalanced across participants.
15871691|NCT03868488|Behavioral|Imagery tasks|All participants need to finish both visual imagery tasks and auditory imagery tasks. Visual imagery tasks and auditory imagery tasks will be carried out at intervals to avoid the influence of different tasks. The sequence of imagery tasks will be counterbalanced across participants.
15871692|NCT03868475|Procedure|Vacuum-assisted percutaneous excision|The intervention group will undergo the vacuum assisted percutaneous excision (VAPE). All VAPE procedures will be performed on a digital supine table using the ATEC© Breast Biopsy System hand piece (Hologic) with a 9-gauge needle and a 10 or 20 mm aperture providing 6-mmHg of suction strength to completely excise the breast lesion.
15871693|NCT03868475|Procedure|Open surgical excision|The control group will undergo standard open surgical excision of the breast lesion. This will be done in the operating room using preoperative image-guided localization with radioactive seed (I-125) or in the procedure room of the Breast Care Centre if appropriate (i.e. lesion is palpable and localization is not required).
15871694|NCT03868462|Device|Optos P200TE|The P200TE Ophthalmoscope provides widefield Scanning Laser Ophthalmoscope (SLO) fundus imaging and Optical Coherence Tomography (OCT) imaging in one device.
15871695|NCT03868462|Device|Predicate Device|The predicate device is an optical coherence tomography system intended for in vivo imaging, axial cross-sectional, three-dimensional imaging and measurement of anterior and posterior ocular structures.
15871696|NCT03868449|Other|Question Prompt List|Question prompt list
15871697|NCT03868449|Other|3 questions|3 questions from the AskShareKnow model
15871698|NCT03868436|Drug|Methoxyflurane 3mL|As soon as possible following enrollment and initial procedures, the patient will be supplied with a PENTHROX™ kit which includes one inhaler containing 3 mL of MEOF for pain management. A member of the research team will train the patient to self-administer MEOF. PENTHROX™ is an approved (trademarked) product in Canada and is commercially available in a combination blister pack with one 3 mL sealed bottle and one PENTHROX™ inhaler with the Activated Carbon (AC) chamber.
15871699|NCT03868423|Drug|Brigatinib|90 mg orally QD for 7 days followed by 180 mg orally QD continuously thereafter. One cycle of therapy will consist of 28 days of treatment.
15871700|NCT03868423|Other|Laboratory Biomarker Analysis|Correlative studies
15871701|NCT03868423|Other|Quality-of-Life Assessment|Ancillary studies
15871702|NCT03868423|Other|Questionnaire Administration|Ancillary studies
15871703|NCT03868410|Device|New rTMS Approach|Participants in this arm will receive rTMS-based facilitation of the contralesional dorsal premotor cortex (cPMd) located in the non-stroke hemisphere before start of each session. High-frequency rTMS (5-Hz) will be delivered using five 1-min trains of 300 pulses each (total 1500 pulses) for a period of 10 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 3 days a week for 5 weeks, i.e., for a total of 15 sessions.
15871737|NCT03868072|Drug|Chong Kun Dang Tofacitinib Tablet|Chong Kun Dang Tofacitinib Tablet 1T single oral administration under fasting
15871738|NCT03868059|Drug|LPCN 1021|LPCN 1021 is gelatin capsule product provided as 112.5 mg testosterone undecanoate per capsule.
15871704|NCT03868410|Device|Conventional rTMS Approach|Participants in this arm will receive rTMS-based facilitation of the ipsilesional primary motor cortex (iM1) before the start of each session. iM1 will be facilitated using a widely-used approach of stimulation delivered to inhibit the contralesional motor cortices located in the non-stroke hemisphere. Low-frequency rTMS (1-Hz) can inhibit the excitability of targeted regions. Therefore, this low-frequency approach will be delivered to suppress the excitability of the non-stroke hemisphere. A total of 1500 pulses will be given for 25 minutes. Immediately after the completion of rTMS, participants will undergo upper limb training for a total of one hour. Participants will receive these interventions 3 days a week for 5 weeks, i.e., for a total of 15 sessions.
15871705|NCT03868397|Diagnostic Test|Liver MRI|"Liver MRI including 4D flow sequence is performed twice in liver transplantation recipients, before and 1 month-after transplantation.
~In donor candidates, liver MRI including 4D flow sequence is performed twice in 1-3 weeks to assess repeatability of the technique."
15871706|NCT03868371|Dietary Supplement|High phosphorous containing meal|A meal with a high phosphorous content
15871707|NCT03868371|Dietary Supplement|Low phosphorous containing meal|A meal with a low phosphorous content
15871708|NCT03868358|Device|transcranial magnetic stimulation|"The stimulations were performed by MagStim Rapid2. Participants in active comparator will receive active transcranial magnetic stimulation(Real Stimulation) daily for two weeks.
~Participants in sham comparator will receive no stimulation(Sham Stimulation) daily for two weeks"
15871709|NCT03868319|Procedure|lung protective ventilation strategy|low tidal volumes and positive end-expiratory pressure mechanical ventilation during robot-assisted laparoscopic radical cystectomy for bladder cancer
15871710|NCT03868319|Procedure|nonprotective ventilation|large tidal volume and zero PEEP mechanical ventilation during robot-assisted laparoscopic radical cystectomy for bladder cancer
15871711|NCT03868306|Other|CBC , Iron study and Haemoglobin electrophoresis .|The study will conducting on 100 patients of microcytic hypochromic anaemia who recruited from the hematology outpatient clinic , Assiut University Children Hospital . Beside history and clinical examination , the studied cases will be subjected to the following investigations Complete blood count ( CBC ) with comparison of MCV , RBCs count , RDW and RDWI . Determination of serum ferritin , serum iron and total iron bending capacity ( TIBC ) . HB electrophoresis . Patient with HBA2 more than 3.2 % are identified as beta thalassemia trait and patients with serum ferritin less than 12 ng / ml are identified as IDA cases. Validity of both discrimination indices are evaluated by calculating there sensitivity , specificity , positive predictive value , negative predictive value and Youden index ( YI ) Based on statistical criteria in ideal test should have high sensitivity and specificity and Youden index.
15871712|NCT03868293|Device|Focused ultrasound|Pulsed low intensity focused ultrasound
15871713|NCT03868280|Procedure|Antegrade femoral nailing Supine Position|Antegrade femoral nailing in Supine Position using a Fracture Table
15871714|NCT03868280|Procedure|Antegrade Femoral Nailing Lateral Position|Antegrade femoral nailing in Lateral Position using a Free drape
15871715|NCT03868254|Device|XEN Group|Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent as a standalone procedure from 1 January 2014 to 1 October 2015.
15871716|NCT03868254|Procedure|Phacoemulsification|Chart review was conducted in participants with open angle glaucoma who underwent placement of the implant XEN 45 Gel Stent in combination with phacoemulsification (Phaco) from 1 January 2014 to 1 October 2015.
15871717|NCT03868241|Device|Coated devices|Gold-silver-palladium coated devices (endotracheal tube, central venous catheter and urinary catheter) will be used whenever necessary. All three devices are required to be inserted as soon as possible after randomization and need for all three devices are the main inclusion criteria
15871718|NCT03868241|Device|Control|Devices without coating available at each participating intensive care unit
15871719|NCT03868228|Procedure|Pressurised Intraperitoneal Aerosol Chemotherapy (PIPAC)|Use of CapnoPen device to aerosolise Oxaliplatin 92mg/m2 chemotherapy 6-8 weekly intervals for intraperitoneal distribution via laparoscopy.
15871720|NCT03868215|Diagnostic Test|Next-generation sequencing (NGS)|NGS test for colorectal tumor-specific plasma ctDNA methylation markers prior to endoscopy and before surgical resection.
15871721|NCT03868202|Drug|Estradiol Transdermal Product|Hormone replacement therapy will be given to postmenopausal women for up to 1 month.
15871722|NCT03868189|Other|Electroneuromyography with ultrasound|Patients whose electroneuromyography examination will be performed using an ultrasound
15871723|NCT03868189|Other|Electroneuromyography without ultrasound|Patients whose electroneuromyography examination will be performed without ultrasound (fake tracking)
15871724|NCT03868176|Other|short message service|short message service
15871725|NCT03868150|Drug|Amiodarone Injection|Patients stratified into the amiodarone study group were administered amiodarone until day of discharge. Amiodarone administration began intraoperatively with the administration of a 150 mg IV amiodarone loading bolus prior to separation from coronary pulmonary bypass, followed by 1 mg/min IV amiodarone for six hours (360 mg), then 0.5 mg/min IV amiodarone for 18 hours (540 mg), then transitioned to 400 mg oral amiodarone twice a day until discharge. In total, patients in the amiodarone treatment group received 1,050mg of IV amiodarone plus 800mg/day of oral amiodarone thereafter until discharge.
15871726|NCT03868150|Device|Intraoperative Rapid Atrial Pacing|Intraoperative rapid atrial pacing for 30 seconds after cannulation and prior to initiation of cardiopulmonary bypass by having the surgeon attach insulated forceps to the superior right atrial free wall and connected to a temporary pacemaker to burst pace at a rate of 800 bpm for 30 seconds (pulse width 1.0 ms, output: 20 mA) Patients are monitored for successful atrial fibrillation induction defined as 30 seconds of sustained atrial fibrillation on ECG.
15871727|NCT03868137|Drug|Ibuprofen|3 doses of Ibuprofen 800 mg
15871728|NCT03868137|Drug|Placebos|Placebo
15871729|NCT03868124|Combination Product|G2TR intraocular implant containing travoprost|Provided in Arm/Group descriptions
15871730|NCT03868124|Drug|Sham surgery + active-comparator eye drops|Sham surgery plus postoperative active-comparator eye drops (Timolol Maleate ophthalmic solution, 0.5%)
15871731|NCT03868111|Drug|Sufentanil|The infusion rate of sufentanil is adjusted to achieve a surgical pleth index of 20-50 throughout the operative time.
15871732|NCT03868111|Drug|Remifentanil|The infusion rate of remifentanil is adjusted to achieve a surgical pleth index of 20-50 throughout the operative time.
15884476|NCT03770286|Device|38% Silver diamine fluoride|Topical varnish
15871739|NCT03868046|Drug|Treatment with immune checkpoint inhibitors.|Treatment with approved immune checkpoint inhibitors, namely ipilimumab, nivolumab, pembrolizumab, atezolizumab and avelumab, alone or in combination, administered per standard protocol.
15871740|NCT03868046|Diagnostic Test|Blood tests.|Patients will undergo ordinary blood tests obtained at specific moments predefined per protocol and extraordinary blood tests at the time of the detection of an eventual irAE.
15871741|NCT03868033|Drug|Zoledronic Acid|Use Zoledronic acid as a sequential therapy after denosumab treatment for more than 2 years
15871742|NCT03868033|Drug|Denosumab|Continuous Denosumab treatment in arm 1 for two years or as a 2nd year treatment in arm 2 for one year
15871743|NCT03868020|Procedure|Computed Tomography|Undergo PET/CT
15871744|NCT03868020|Radiation|Fluciclovine F18|Given IV
15871745|NCT03868020|Procedure|Positron Emission Tomography|Undergo PET/CT
15871746|NCT03868007|Device|RIC|The RIC procedure during which bilateral arm cuffs are inflated to a pressure of 200mmHg for five cycles of 5 min followed by 5 min of relaxation of the cuffs.
15871747|NCT03868007|Device|sham-RIC|The sham-RIC procedure during which bilateral arm cuffs are inflated to a pressure of 60mmHg for five cycles of 5 min followed by 5 min of relaxation of the cuffs.
15871748|NCT03867994|Drug|Atorvastatin|
15871749|NCT03867994|Drug|Carvedilol|
15871750|NCT03867994|Drug|saline|
15871751|NCT03867981|Behavioral|Internet-based weight loss program|12-month, Internet-based weight loss/maintenance program.
15871752|NCT03867981|Behavioral|Brief phone coaching|Some individuals will receive 3 weeks of phone coaching. Coaching calls will occur 1x/week, starting at week 5. Once coaching calls are completed, the participant will not have any other contact with their coach.
15871753|NCT03867981|Behavioral|Extended phone coaching|Some individuals will receive 12 weeks of phone coaching. Coaching calls will occur 1x/week, starting at week 5. Once coaching calls are completed, the participant will not have any other contact with their coach.
15871754|NCT03867968|Behavioral|TIPS Intervention|Web-based training for family member.
15871755|NCT03867968|Behavioral|Control|Traumatic Brain Injury website for family members.
15871756|NCT03867955|Other|Collection of datas|Collection of datas by videopupillometer results: pupil diameter and variation of the pupillary diameter.
15871757|NCT03867942|Drug|Monolayer group|Monolayered combination of gemigliptin and rosuvastatin
15871758|NCT03867942|Drug|Bilayer group|Bilayered combination of gemigliptin and rosuvastatin
15871759|NCT03867929|Other|25-Hydroxy vitamin D|27.32 is calculated as a cut fo level for 25 hydroxy vitamin D deficiency
15871763|NCT03867903|Device|Babysparks Application|mHealth application, BabySparks©, will be implemented for infant and toddler developmental activities through 24 months of age. (Currently, BabySparks is only designed to work on the developmental milestones through 24 months of age, and therefore the use of the application will no longer be applicable to the patient after reaching a developmental age of 24 months. If the subject has not reached a developmental age of 24 months at the time he/she is chronologically 24 months, the subject/family will be able to continue to utilize the application for a maximum of 24 months from the time they began to use the application or until reaching a study endpoint of reaching 24 months developmentally or death, whichever the infant reaches first.)
15871764|NCT03867903|Other|pre and post-test Redcap Survey|Prior to starting the use of the application, parents will be given a REDCap survey to complete to determine their current awareness and interventions being implemented with their child related to reaching developmental milestones. Data entered into application by the subject's caregivers will be stored by BabySparks.After completion of the use of the application (subject reaches a study endpoint), the caregivers will be asked to complete a REDCap survey asking them about their experience with the application.
15871765|NCT03867890|Other|no intervention|
15871766|NCT03867877|Other|Periodized training with motor practice|Exercises at 75-80% of the subject's maximum for strength exercise using contractions with 2 second concentric and 3 second eccentric for the strength day. 30-80% of subjects' maximal strength for the power day with high-speed concentric and 2 second eccentric contractions, and exercises that simulate activities of daily living for the motor practice day. All resistance-training will be performed on Keiser air-driven machines. Subjects will perform 10 exercises targeting all major muscle groups. The training will last for 12 consecutive weeks, for a total of 36 visits. Each visit will be approximately 60 minutes long and will consist of 5 minutes warm-up, 50 minutes of training and five minutes of cool-down.
15871767|NCT03867877|Other|Simple Periodized Training|Exercises at 75-80% of the subject's maximum for strength using contractions with 2 second concentric and 3 second eccentric for the strength day. 30-80% of subjects' maximal strength for the power day, with high speed concentric and 2 second eccentric contractions, and for hypertrophy day at 60-75% of subjects' maximum strength. All resistance-training will be performed on Keiser air-driven machines. Subjects will perform 10 exercises targeting all major muscle groups. The training will last for 12 consecutive weeks, for a total of 36 visits. Each visit will be approximately 60 minutes long and will consist of 5 minutes exercise using contractions warm-up, 50 minutes of training and five minutes of cool-down.
15871768|NCT03867864|Device|Necklace with essential oil for the first 4 weeks|The necklaces contain essential oil.
15871769|NCT03867864|Device|Necklace without essential oil for the first 4 weeks|The necklaces do not contain essential oil.
15871770|NCT03867864|Other|Washout|Washout (do not wear the necklace) for one week for two groups, then two groups cross-over.
15871771|NCT03867864|Device|Necklace with essential oil for last 4 weeks|The necklaces contain essential oil.
15871772|NCT03867864|Device|Necklace without essential oil for last 4 weeks|The necklaces do not contain essential oil.
15871773|NCT03867851|Drug|IBsolvMIR|Study drug IBsolvMIR
15871774|NCT03867851|Drug|Heparin|Clinical praxis
15871775|NCT03867838|Device|compliant support|Participants will be given compliant arm support and their reachable workspace measured
15871776|NCT03867825|Device|Non-invasive hemodynamic monitoring|Impedance cardiography
15871777|NCT03867812|Other|SOBAR|SOBAR is a high protein nutrition bar optimized to delay gastric emptying
15871779|NCT03867812|Other|Full meal|Stouffer's Bistro Crostini 5 cheeses, Oikos Strawberry yogurt, Tropicana Orange juice, Dad's oatmeal cookie
15871780|NCT03867799|Drug|Nivolumab|Immunotherapy
15871781|NCT03867786|Behavioral|Exercise|Participants will complete an acute exercise visit.
15871782|NCT03867786|Behavioral|Video Control|Participants will complete a video control visit.
15871783|NCT03867773|Behavioral|Time restricted feeding|TRF subjects will consume food ad libitum during the feeding window (4-h or 6-h window), and refrain from eating during the fasting window (20-h or 18-h window)
15871784|NCT03867760|Behavioral|Recorded Hypnosis Intervention|The RHI consists of four digital recordings developed by the investigator using standardized hypnosis scripts for pain reduction and uploaded to a MP3 player. The scripts were developed for patients with chronic pain and tested by a psychologist who is an expert in hypnosis research. Participants will listen to the recordings daily for 28 days in the prescribed order (4 recordings for 3 days each, and then any recording for the remaining 16 days). The script includes an induction, suggestions for how to access inner resources and manage pain, and post-hypnotic suggestions for permanence of hypnosis benefits and self-hypnosis practice.
15871785|NCT03867760|Behavioral|Recorded Relaxation Intervention|The recorded relaxation intervention consists of four digital recordings developed by the investigator using standardized relaxation scripts and uploaded to a MP3 player. Participants will listen to the recordings daily for 28 days in the prescribed order (4 recordings for 3 days each, and then any recording for the remaining 16 days).
15871786|NCT03867747|Radiation|Cardiac Radiosurgery|Image-guided stereotactic body radiation therapy
15871787|NCT03867734|Drug|Aztreonam|2g IM Aztreonam
15871788|NCT03867721|Device|Ventilator|Comparison of two ventilators for mouthpiece ventilation
15871789|NCT03867708|Radiation|ASD device closure|transcatheter secundum ASD device closure
15871790|NCT03867695|Drug|Ropivacaine|At the end of the lobectomy VATS procedure, 0,5 mL/kg of 0.375% ropivacaine will be administered.
15871791|NCT03867695|Drug|sterile saline|Patients will receive a placebo injection with 0,5 mL/kg of sterile normal solution
15871792|NCT03867682|Biological|Lintuzumab-Ac225|In the Phase I, patients will be enrolled into the following dose escalation cohorts: 0.50 μCi/kg, 1.0 μCi/kg, and 1.5 μCi/kg. If the 0.50 μCi/kg dose is determined to exceed the MTD, a 0.25 μCi/kg dose will be explored.
15871793|NCT03867682|Drug|Venetoclax|400 mg daily will be taken orally on Days 1-21 of a 28-day cycle. There will be a ramp up of venetoclax dosing in the first cycle, with 100 mg administered on Day 1, 200 mg on Day 2, and 400 mg on Day 3 and Day 4 and later. Patients on antifungal azoles should receive one-half these doses, up to a maximum of 200 mg of venetoclax.
15871794|NCT03867682|Drug|Spironolactone|25 mg by mouth daily, administered on Cycle 1 Day 15 and continued for 12 months after the subject's last treatment with lintuzumab-Ac225.
15871795|NCT03867669|Other|Open Bay Unit|The eligible infants will be randomized at birth/admission to either the single patient room (experimental) or the open bay unit (Comparator)
15871796|NCT03867669|Other|Single patient room|The eligible infants will be randomized at birth/admission to either the single patient room (experimental) or the open bay unit (Comparator)
15871797|NCT03867656|Other|GLP-2|GLP-2 injection
15871798|NCT03867656|Other|GIP|GIP injection
15871799|NCT03867656|Other|Placebo|Placebo injection
15871800|NCT03867630|Procedure|Transforaminal Block|Epidural block via neural foramen of lumbar spine
15871801|NCT03867617|Other|Regulatory T cells|Single infusion of expanded regulatory T cells.
15871802|NCT03867617|Drug|Tocilizumab|Treatment during first month post-transplant.
15871803|NCT03867617|Other|Bone marrow|Infusion of donor bone marrow cells.
15871804|NCT03867617|Procedure|Kidney transplant|Living donor kidney transplantation.
15871805|NCT03867617|Other|Immunosuppressive drug therapy|Immunosuppressive drug therapy.
15871806|NCT03867604|Procedure|Sham injection|Injection to the subcutaneous layer at upper trapezium level
15871807|NCT03867604|Procedure|Fascia injection|Injection to the fascia below upper trapezium muscle
15871808|NCT03867591|Other|Gastro-AD®|"The product under study is Gastro-AD® fermented soy powder in the form of orodispersible flavored powder packed in non-transparent sachets.
~Content: 1 g of Gastro-AD® powder per sachet + flavoring agents."
15871809|NCT03867591|Other|Placebo|The placebo product will have very similar appearance, color, texture and taste as the Gastro-AD® flavored sachet. The placebo sachets contain the respective amount of maltodextrin (1 g) and exactly the same flavoring and coloring agents as Gastro-AD® powder flavored sachets.
15871810|NCT03867578|Diagnostic Test|HR-MRI|The first 5 patients will undergo HR-MRI scans using different sequence parameters. Results in these patients will then be assessed along with standard CT Imaging to determine which sequences appear to best identify peritoneal disease. The optimal HR-MRI sequences will then be used for the next 19 patients in the Testing phase to formally define their performance compared to standard imaging.
15871811|NCT03867578|Diagnostic Test|Standard CT Imaging|Standard CT scans will be performed for preoperative imaging in all patients.
15871812|NCT03867578|Diagnostic Test|Ultrasound|Ultrasound Elastography will be performed using an FDA-Approved diagnostic GE ultrasound scanner
15871813|NCT03867565|Other|Nutritional intervention|Indirect calorimetry Weight development Nitrogen balance Food records Physical activity Nutritional risk screening and assessment Inflammatory response Wound healing as number of days from burn to no more need of dressing changes via health care facility Frequency of infections as the number, sort, dose, and length of antibiotic treatment(s) from burn to no more need of dressing changes via health care facility
15871814|NCT03867552|Procedure|Altered gas (86% CO2, 10% N2O, 4% O2)|Assessment of pain degree after laparoscopic surgery with the altered gas (86% CO2, 10% N2O, 4% O2)
15871815|NCT03867552|Procedure|Standardized gas (100% CO2)|Assessement of pain degree after laparoscopic surgery with the standardized gas (100% CO2)
15871816|NCT03867539|Other|Differing pain management strategy|"The investigators aim to investigate an alternative (vs standard) pain management strategy for post operative carpal tunnel release. All drugs used are FDA approved for these indications, and no drug itself is being investigated."
15871817|NCT03867513|Other|Multimodal imaging|All participants will attend the Sir Peter Mansfield Imaging Centre for a scanning session using three imaging systems (SQUID MEG, OPM MEG and 7T MRI), cognitive testing and symptom questionnaires. Remote symptom monitoring and cognitive testing at three and six months.
15871818|NCT03867500|Drug|Niacin|All participants will receive intravenous Niacin and each participant will serve as their own saline control on the second study
15871819|NCT03867500|Other|Saline|All participants will serve as their own controls with a saline infusion study day.
15871820|NCT03867487|Drug|Empagliflozin 10 MG|Participants will take a 10 mg oral tablet of empagliflozin, an orally-active inhibitor of sodium-glucose co-transporter 2 (SGLT2)
15871821|NCT03867487|Drug|Placebo Oral Tablet|Participants will take an identical appearing oral tablet with zero active ingredient.
15871822|NCT03867474|Behavioral|Mindfulness-Based Stress Reduction (MBSR)|The intervention group will be delivered in a group-based format, for one three-hour session per week for an 8-week period. Each session will consist of mindfulness practice (e.g. lying down body scan, sitting meditation, mindful eating, mindful movements such as walking and light hatha yoga movements) along with an inquiry about the practice. Strategies on stress reactivity, responding to stress, and some basic content on cognitive behaviour therapy principles will also be taught. Participants will be placed in dyads during the group. Homework practice will be given to complete on a daily basis for approximately 30-45 minutes. During week six participants will attend an all-day silent meditation retreat on a Saturday (Total of 10 sessions = 8 sessions, 1 orientation, and 1 all-day retreat).
15871823|NCT03867461|Procedure|Venous Sinus Stenting|Venous sinus stenting is performed under general anesthesia. Patients are loaded with aspirin and clopidogrel before the procedure. After induction, the right femoral vein is accessed and an 8 F sheath is placed. Intravenous heparin is administered. A 0.070-0.088 guide catheter is navigated into the ipsilateral jugular vein near the jugular bulb. Pre-stenting manometry is performed in every patient. To do so, a Renegade Hi-Flo microcatheter is navigated into the superior sagittal sinus and then used to measure ipsilateral venous pressures across the site of outflow obstruction (this will be the time point where the study intervention will be performed).
15871824|NCT03867461|Other|Adjustment to end-tidal carbon dioxide concentrations ( 38-40 mmHg range)|End-tidal carbon dioxide concentrations will be adjusted to fall in the End-tidal carbon dioxide concentrations will be adjusted to fall in the 38-40 mmHg range
15871825|NCT03867461|Other|Adjustment to Mean Arterial Pressure (100-110 mmHg range)|Mean arterial pressure will be adjusted to fall in the 100-110 mmHg range
15871826|NCT03867461|Other|Adjustment to Mean Arterial Pressure (60-80 mmHg range)|Mean arterial pressure will be adjusted to fall in the 60-80 mmHg range
15871827|NCT03867461|Other|Adjustment to end-tidal carbon dioxide concentrations (24-26 mmHg range)|End-tidal carbon dioxide concentrations will be adjusted to fall in the 24-26 mmHg range
15871828|NCT03867409|Behavioral|message delivered via virtual technology|The intervention is precision messaging tailored to target audiences through development and evaluation of culturally sensitive, interactive messages about CRC screening delivered using VHT. The study will investigate whether interactive, tailored messages contribute to an overall enhancement of knowledge of CRC and screening options by eliciting positive attitudes and behaviors toward FIT screening.
15871829|NCT03867396|Device|CROS|Advanced Bionics CROS
15871830|NCT03867396|Device|Hearing Aid|Advanced Bionics Naida hearing aid
15871831|NCT03867396|Other|Cochlear Implant Alone|No hearing device on contralateral ear
15871832|NCT03867383|Drug|Calcium Chloride|"All included in intervention description.
~1 gram of calcium chloride in total 60 milliliters normal saline"
15871833|NCT03867383|Drug|Placebo|60 milliliters normal saline
15871834|NCT03867370|Drug|Toripalimab (JS001 )|Given IV
15871835|NCT03867370|Drug|Toripalimab (JS001 ) Lenvatinib|Given IV 4 mg capsules
15871836|NCT03867370|Drug|Toripalimab (JS001 ) Lenvatinib|Given IV 4 mg capsules
15871837|NCT03867357|Drug|GnRH agonist|Zoladex is a gonadotropin-releasing hormone agonist, or GnRH-A. It is an implant that is injected under the skin (subcutaneously). The implant gradually dissolves and releases the drug over the time between injections. There are two dosages of Zoladex: Zoladex 10.8 mg, which is injected once every 3 months, and Zoladex 3.6 mg, which is injected once a month.
15871838|NCT03867344|Other|Hypoglycemic Hyperinsulinemic Clamp|Participants undergo a 120-minute hypoglycemic hyperinsulinemic clamp procedure.
15871839|NCT03867344|Other|Normoglycemic Hyperinsulinemic Clamp|Participants undergo a 120-minute normoglycemic hyperinsulinemic clamp procedure.
15871840|NCT03867331|Biological|5 microgram VLPM01|VLPM01 is an alpha-VLP pre-erythrocytic malaria vaccine which targets circumsporozoite protein (CSP), adjuvanted with 0.75 mg alum.
15871841|NCT03867331|Biological|15 microgram VLPM01|VLPM01 is an alpha-VLP pre-erythrocytic malaria vaccine which targets circumsporozoite protein (CSP), adjuvanted with 0.75 mg alum.
15871842|NCT03867331|Biological|30 microgram VLPM01|VLPM01 is an alpha-VLP pre-erythrocytic malaria vaccine which targets circumsporozoite protein (CSP), adjuvanted with 0.75 mg alum.
15871843|NCT03867331|Other|Plasmodium falciparum challenge|Expose forearms to five (5) Plasmodium falciparum (strain NF54; clone 3D7) bites
15871844|NCT03867318|Drug|Atorvastatin|Atorvastatin administered orally QD as 10 mg tablets.
15871845|NCT03867318|Drug|Ezetimibe|Ezetimibe administered orally QD as 10 mg tablets
15871846|NCT03867318|Drug|Placebo for Ezetimibe|Single placebo tablet administered orally QD
15871847|NCT03867318|Drug|Placebo for Atorvastatin|Single placebo tablet administered orally QD
15871848|NCT03867305|Device|MOBIDERM|Use of a MOBIDERM mobilizing band after total knee prosthesis
15871849|NCT03867292|Other|Myofascial|"The aim of the application of the crossed hands technique is to produce a deep fascial release, placing the subject in prone position, while the standing physiotherapist will contact with one hand on the spine at the level of the thoracolumbar hinge and with the other hand on the sacrum, so that the hands are crisscrossed. The crossed hands technique will be performed between 90 seconds and 5 minutes.
~The application of the TENS, will be performed for 10 minutes by means of a device, model Compex in the lumbar area, subjects will receive a TENS application of low frequency (less than 40Hz). The electrode - (black) in proximal position or on the most painful zone. The electrode + (red) will be placed distally."
15871850|NCT03867292|Other|Electrotherapy|The application of the TENS, will be performed for 10 minutes by means of a device, model Compex in the lumbar area, subjects will receive a TENS application of low frequency (less than 40Hz). The electrode - (black) in proximal position or on the most painful zone. The electrode + (red) will be placed distally.
15871851|NCT03867279|Other|Flossing|The reeducation exercises are: lunge and hold (the subject performs a lunge increasing the dorsiflexion of the ankle, advancing the tibia as much as possible without taking off the heel of the floor and without valgus of the knee, 15 repetition of 10 seconds of duration each); back squat (squat with a pike supported on scapulae); and chaturanga (from the prone position with extension of elbows and spine, the subject raises upper antero iliac spines performing a shoulder flexion and raising the pelvis to the ceiling maintaining the hip flexion and knees extended and keeping the heels touching the ground. The subjects included in this group will perform the exercises while a compression band is applied to the ankle.
15871852|NCT03867279|Other|Reeducation exercises|The reeducation exercises are: lunge and hold (the subject performs a lunge increasing the dorsiflexion of the ankle, advancing the tibia as much as possible without taking off the heel of the floor and without valgus of the knee, 15 repetition of 10 seconds of duration each); back squat (squat with a pike supported on scapulae); and chaturanga (from the prone position with extension of elbows and spine, the subject raises upper antero iliac spines performing a shoulder flexion and raising the pelvis to the ceiling maintaining the hip flexion and knees extended and keeping the heels touching the ground.
15871853|NCT03867266|Procedure|Ablation with radiofrequency|Ablation point by point on the cavo tricuspid isthmus guided by an index lesion
15871854|NCT03867253|Drug|ORY-2001 Low dose|0.6mg ORY-2001 capsule
15871855|NCT03867253|Drug|ORY-2001 High dose|1.2mg ORY-2001 capsule
15871856|NCT03867253|Drug|Placebo|Placebo capsule
15871857|NCT03867240|Drug|Gabapentin|Gabapentin (10 mg/kg up to 600 mg) will be given 30 minutes prior to being transported to the operating room. The gabapentin will be in the standard liquid with a concentration of 250mg/5mL. Starting postoperative day 1, patients in the experimental group will receive gabapentin three times daily. Dose of gabapentin will be 100 mg for patients <50 kg and 200 mg for patients > 50 kg. Gabapentin will be continued for 5 days postoperatively. If patients are discharged prior to postoperative day 5, they will be provided with gabapentin for the remainder of their doses upon discharge.
15871858|NCT03867240|Other|Placebo|Placebo will be given 30 minutes prior to being transported to the operating room. Placebo will be identically appearing to gabapentin. Starting postoperative day 1, control group will receive placebo medication at the same interval with the appropriate number of capsules or liquid for their weight to match the experimental group. It will be continued for 5 days postoperatively. If patients are discharged prior to postoperative day 5, they will be provided with placebo for the remainder of their doses upon discharge.
15871859|NCT03867227|Device|left atrial appendage occluder implantation|all patients will get implantation of LAA occluder
15871860|NCT03867214|Drug|Tranexamic Acid|1 g of tranexamic acid in 100 mL of normal saline intravenously approximately 15 minutes before incision
15871861|NCT03867214|Drug|Normal saline|100 mL of normal saline intravenously approximately 15 minutes before incision
15871862|NCT03867201|Biological|Erenumab|Administered by pre-filled syringe
15871863|NCT03867201|Other|Placebo|Administered by pre-filled syringe
15871864|NCT03867188|Drug|Liposomal Bupivacaine|A 25 gauge or larger bore needle will be used to inject the liposomal bupivacaine at the site of operation following the prescription guidelines provided by Exparel®. The maximum dose allowable for this study is 266mg or 20 mL as indicated in the FDA package insert.
15871865|NCT03867175|Radiation|Stereotactic Body Radiation Therapy|Patients undergo 3-10 treatments of stereotactic body radiation therapy (SBRT)
15871866|NCT03867175|Biological|Pembrolizumab|Patients undergo 3-10 treatments of SBRT. Patients also receive pembrolizumab IV over 30 minutes every 3-4 weeks for 1 year at the discretion of the treating physician.
15871867|NCT03867162|Biological|Live Attenuated Tularemia Vaccine|Subjects will be vaccinated with a bifurcated needle; approximately 0.06 mL of the reconstituted vaccine will be placed on the volar surface of the forearm and applied by multiple puncture.
15871868|NCT03867149|Other|neuroimaging|neuroimaging including high-resolution imaging of the thalamus, DTI and resting state fMRI
15871869|NCT03867149|Other|Neuropsychological assessment|neuropsychological assessment of memory, language, executive functions and mood
15871870|NCT03867136|Drug|PZA sensitivity guided ultra-short all Oral Regimen|Pyrazinamide 1500 mg daily; Levofloxacin ≤50kg 500 mg daily, >50kg 750mg daily; Linezolid: 600 mg daily; Cycloserine ≤50kg 500 mg daily, >50kg 750mg daily; Clofazimine 100 mg daily; All treatment is taken daily;
15871871|NCT03867136|Drug|Standardized Shorter Regimen|Pyrazinamide 1500 mg daily;Levofloxacin 400 mg daily,; Prothionamide ≤50kg 500 mg daily, >50kg 750mg daily; Ethambutol: ≤50kg 750 mg daily, >50kg 1000mg daily; Clofazimine: 100 mg daily; Amikacin 600mg daily; High-dose isoniazid 600mg daily. All treatment is taken daily.
15871872|NCT03867123|Drug|2-OHOA|Arm 1: Daily for 6 weeks. Arm 2: daily, two 28-day cycles
15871873|NCT03867123|Radiation|RT|In Arm 1: Fractionated focal irradiation of 1.8-2 Gy/fraction/day, 5 days/week, 6 weeks. Total dose up to 60 Gy
15871874|NCT03867123|Drug|TMZ|Arm 1: 75 mg/m2/day, daily, 6 weeks Arm 2: 200 mg/m2/day, daily the first 5 days of two 28-day cycles (in case of toxicity, TMZ dose may be reduced to 150 mg/m2/day at Cycle 3 to allow for recovery)
15871875|NCT03867110|Drug|Placebo|
15871876|NCT03867110|Drug|Ezetimibe 10 mg|
15871877|NCT03867110|Drug|Atorvastatin 10 mg|
15871878|NCT03867110|Drug|Atorvastatin 20 mg|
15871879|NCT03867110|Drug|Atorvastatin 40 mg|
15871880|NCT03867110|Drug|Atorvastatin 80 mg|
15871881|NCT03867097|Drug|Placebo IV infusion|Study drug will be initiated at a starting dose of 0.5 ng/kg/min up to 2.0 ng/kg/min. Subjects will receive study drug for 5 consecutive days as an IV infusion over 6 hours each day via a peripheral line.
15871882|NCT03867097|Drug|Iloprost Injection, for intravenous use|Study drug will be initiated at a starting dose of 0.5 ng/kg/min up to 2.0 ng/kg/min. Subjects will receive study drug for 5 consecutive days as an IV infusion over 6 hours each day via a peripheral line.
15871885|NCT03867071|Other|recombinant erythropoietin injection|Intravenous injection of 300 international units (IU) per kg (kg) of recombinant erythropoietin with a maximum of 20.000 IU, daily for a maximum of 10 days (D0 to D9).
15871886|NCT03867071|Other|placebo injection|Intravenous injection 0,9% saline solution.
15871887|NCT03867058|Behavioral|Electrode selection/electrode configuration|Electrodes will be chosen based on their spatial tuning curves. Focused stimulation will be applied to electrodes with good temporal processing acuity.
15871888|NCT03867045|Device|Usability of an electronic symptom management application|Usability of an electronic symptom management application in a pilot group of patients receiving cabozantinib for mRCC through data analytics and feedback from users
15871889|NCT03867032|Behavioral|Auditory training|Training with psychophysical tests (amplitude modulation detection on single electrodes) for improving speech recognition
15871890|NCT03867019|Diagnostic Test|Heart rate variability parameters monitoring|"No intervention- only additional monitoring of heart rate, physical tests and filling of questionnaires:
~Heart rate variability parameters monitoring- by wearing a Polar watch (RS800CX).
~Isometric grip test- by using a Jamar Hand Held Dynamometer.
~Questionnaires:
~Dizziness Handicap Inventory (DHI) - hebrew version.
~Stait-Trait Anxiety Inventory (STAI)"
15871891|NCT03867006|Dietary Supplement|Protein|In addition to their normal meal, patients will eat 30g of whey protein every lunch during 90 days.
15871892|NCT03867006|Dietary Supplement|Protein and Carbohydrate|In addition to their normal meal, patients will eat 30g of whey protein every lunch during 90 days and eat 60g of carbohydrates 2h after every diner during 90 days.
15871893|NCT03866993|Biological|AK105|IV infusion
15871894|NCT03866993|Drug|Paclitaxel|IV infusion
15871895|NCT03866993|Drug|Carboplatin|IV infusion
15871896|NCT03866993|Drug|Placebo|IV infusion
15871897|NCT03866980|Biological|AK105|IV infusion
15871898|NCT03866980|Drug|carboplatin|IV infusion
15871899|NCT03866980|Drug|pemetrexed|IV infusion
15871900|NCT03866980|Drug|placebo|IV infusion
15871901|NCT03866967|Biological|AK105|intravenous (IV) infusion
15871902|NCT03866954|Combination Product|EE-TP|Ecoli thymidine phoshorylase encapsulated within autologous erythrocytes
15871903|NCT03866941|Behavioral|causes of abuse synthetic cannibinoids|Epidemiological data (age, sex, residence, occupation, route of abuse, the cause of abuse and smoking) (2) Symptoms and signs (seizures, psychosis, hallucinations) (3) Injuries and their relation to violence (type of wound, type of instrument, number of injuries, external or internal injuries and assailant or victim).
15871904|NCT03866928|Drug|Stiripentol|1500 mg of stiripentol b.i.d.
15871905|NCT03866915|Diagnostic Test|Aortic pulse wave velocity measurement|Aortic pulse pulse wave velocity (AoPWV) measured by photoplethysmography
15871906|NCT03866915|Diagnostic Test|6 minutes walking test|This test is performed routinely in the pre-rehabilitation units or in external anesthesiology consultations during the preoperative visit. In essence, it consists in measuring the maximum distance the patient is able to walk in 6 minutes, in a short walk in a corridor, simultaneously assessing the heart rate, oxygen saturation and the degree of dyspnea. In general, healthy people can walk between 400 and 700 meters in 6 minutes, depending on age, height and sex.
15871907|NCT03866902|Behavioral|Nutrition and Physical Activity Intervention|"Mothers. Twelve weekly classes for one hour focused on nutrition and exercise education and coping skills training followed by a forty five minute exercise class for mothers. Then they will return for one hour for continued support and a forty-five minute exercise class.
~Children. Twelve weekly classes for one hour focused on Color Me Healthy and one hour of free play. Then 6 monthly continued support classes where a Color Me Healthy class will be reviewed and they will have one hour of free play."
15871908|NCT03866902|Other|English for Second Language Intervention|"Mothers. Control group mothers will receive 12 weekly English for Second Language classes for one hour and forty-five minutes. Then 6 monthly one hour and forty minute follow-up classes receiving English for Second Language material.
~Children. Control group children will receive 12 weekly one hour and forty five minutes of having books read to them. Followed by 6 monthly meetings for one hour and 45 minutes being read to and coloring with crayons."
15871909|NCT03866889|Other|Strength|"In the performance of the squat exercise (Back Squat), the subjects will be standing, with an Olympic bar behind their neck, supported on both trapezoids, while the hands will help to hold and stabilize the bar, taking it from below.
~For hamstring curl, the subject will be in the prone position, clinging to the backrest, with the legs under the arm that lifts the weight.
~The deadlift exercise will be performed from the standing posture, holding the bar with your arms extended and the trunk straight, while your hands will hold the bar at the height and separation of the hips.
~Finally, in the quadriceps chair the subject will find himself sitting with his back straight and supported on the back of the seat, while the legs will go under the arm that lifts the weight."
15871910|NCT03866889|Other|Normal activity|The subjects included in the control group will continue to perform the same strength training plan that they did before starting this one. The periodicity will be the same (4 days / week) and with the same intensity.
15871911|NCT03866876|Other|Eucapnic pH|Collection of Biological marker (proposed by Racinet): eucapnic pH
15871912|NCT03866863|Other|Intrauterine growth restriction (IUGR)|Collection of number of patient's diagnosed with IUGR as defined in accordance with the consensus-based definition for early and late IUGR : birthweight < 3rd centile using French AUDIPOG curves adjusted for term and sex or estimated fetal weight < 10th centile combined with umbilical artery pulsatility index > 95th centile or breakage of growth.
15871913|NCT03866850|Behavioral|Phase duration|We will vary the phase duration in the stimulation, and examine detection threshold, spatial spread of neural excitation, and speech recognition as the outcomes.
15871914|NCT03866837|Dietary Supplement|Galacto-oligosaccharides|Galacto-oligosaccharides are classified as Generally Recognized As Safe (GRAS) by the U.S. Food and Drug Administration, are components of cow's milk and have been used repeatedly in clinical trials without adverse effects.
15871915|NCT03866837|Dietary Supplement|Bovine lactoferrin|Bovine lactoferrin is classified as Generally Recognized As Safe (GRAS) by the U.S. Food and Drug Administration, is a component of cow's milk and has been used repeatedly in clinical trials without adverse effects.
15871916|NCT03866837|Dietary Supplement|Multiple micronutrient powders with 5 mg iron|The multiple micronutrient powders are composed of Vitamin A, 400 μg; Vitamin D, 5 μg; Tocopherol Equivalents, 5 mg; Thiamine, 0.5 mg; Riboflavin, 0.5 mg; Vitamin B6, 0.5 mg; Folic Acid, 90 μg; Niacin, 6 mg; Vitamin B12, 0.9 μg; Vitamin C, 30 mg; Copper, 0.56 mg; Iodine, 90 μg; Selenium, 17 μg; Zinc, 4.1 mg; Phytase, 190 FTU; Iron, 5 mg [(as Ferrous fumarate, 2.5 mg and sodium iron ethylenediaminetetraacetate (NaFeEDTA), 2.5 mg].
15871917|NCT03866824|Drug|injection of Platelet Enhanced Plasma(PRP)|intra-articular injection
15871920|NCT03866811|Behavioral|Dr. Erica|The 10 week texting intervention contains the follow characteristics to increase engagement: (1) Dr. ERICA (Emergency Room Interventions to Improve the Care of Adolescents): The persona and brand of the intervention is Dr. Erica, a relatable, empathetic, straightforward and reliable female doctor; (2) Personalization: Information collected at baseline will be incorporated into each individualized program; (3) Interactivity: The majority of text message algorithms contain 3-4 two-way automated messaging conversations. (4) Feedback loops: The investigators will collect feedback from participants to prompt action; (5) Visual stimuli: Texts include emojis, memes, and other visual stimuli, similar to current teen texting behaviors; (6) Social media: The investigators designed sexual health comic strips posted as an Instagram story; (7) Links and role modeling: Texts contain links to testimonials, influencers, and evidence-based websites.
15871921|NCT03866798|Biological|Panzyga|Immune Globulin, intravenous, human-ifas
15871922|NCT03866785|Diagnostic Test|interview|The goal is to evaluate the needs, the constraints and representations of patients on the practice of physical activity.
15871923|NCT03866785|Diagnostic Test|Adult Physical Activity Questionnaire (APAQ)|The goal of this questionnaire is to evaluate the sedentary lifestyle of patients.
15871924|NCT03866785|Device|Activity actigraph|An activity actigraph will use by the patient for a week. It measures the level of physical activity and the sedentary lifestyle of patients.
15871925|NCT03866785|Other|Peer training|"The goal of the peer training will organize once a week for 3 weeks for a patient.
~After this training, they will have :
~Skills in physical activity advice
~Knowledge of functional signs (symptoms)
~Knowledge to examine heart rate and perceived effort rate"
15871926|NCT03866785|Other|Physical Activity Program|"During the Physical Activity Program, patients will be supervised by peers and a clubs and sports associations labeled sport-health by Olympic and Sports Committee of the Loire Department.
~The peer will coach the patient once a week minimum for 3 months."
15871927|NCT03866772|Drug|Misoprostol Oral Tablet|50 mcg oral consumption
15871928|NCT03866772|Device|double balloon device for cervical ripening|insertion for 6 hours and followed by the above mentioned protocol
15871930|NCT03866746|Drug|Aflibercept Injection|Group A;Under complete aseptic conditions; intravitreal aflibercept injections with dose of 2 mg/0.05 mL per injection was given for the patients. Patients were scheduled to receive 3 loading injections at monthly interval. At the 3rd month; further treatment was planned pro re nata (PRN) according to the response. Injections were discontinued when the CMT reached 250 µm or less. If there was no change in the CMT after two consecutive injections; patients shifted to other line of treatment. Reinjection was continued for the other eyes with re-evaluation of the response every month.In group B Patients received the initial 3 monthly loading doses of IVI of aflibercept followed by MPL therapy (within one week after the 3rd injection). Patients were scheduled for follow-up monthly. Injection followed by MPL was then repeated according to the response as in group A.
15871931|NCT03866746|Other|micropulsed yellow laser|Micropulse yellow IQ 577nm laser (Iridex Corporation, Mountain View, CA, USA) was employed. The Area Centralis lens (laser spot size magnification 0.94) was utilized with 400 mw power, 200μm spot size and 200 ms pulse duration with 5% duty cycle after micropulse mode activation. Laser was applied on clinically visible thickened macula with different number of confluent non- spacing shots in 7x7 grids. Care was taken to begin treatment outside the foveal avascular zone and not to treat the fovea when there was no visible reaction. If there was any visible reaction; treatment was stopped and the power was reduced until there was no visible reaction.
15871932|NCT03866733|Other|continous erector spinea block|Ultrasound guided erector spinea block will be performed while the patient is in left lateral position ) the US probe will be placed in longitudinal parasagittal plane lateral to the T5 spinous process. An 18-gauge epidural needle will be inserted in-plane in a cranial-to-caudal direction until the tip is deep to erector spinae muscle. A 5 cm of epidural catheter will be threaded in cephalad direction. The same steps will be performed on the other side, after the negative aspiration for blood, bolus dose 15 ml of 0.25% bupivacaine will be injected in each of the catheters followed by a continuous infusion of 0.125% plain bupivacaine at the rate of 0.1 ml/kg/h.
15871933|NCT03866733|Drug|intravenous narcotics|intervention: injection of boluses of intra venous Narcotic drugs (fentanyl) in the dose of (1-2mcg/kg) during the surgery after induction of anesthesia then fentanyl infusion through the postoperative first 24 hours postoperative till extubation then intravenous pethidine till 48 hours after surgery.
15871934|NCT03866720|Other|Carbohydrate rich breakfast|A porridge breakfast meal fed at a carbohydrate delivery rate of 7.3 mg/kJ of each participants resting metabolic rate.
15871935|NCT03866720|Dietary Supplement|Whey protein enriched breakfast|A porridge breakfast meal in which 15 grams of whey protein is substituted in place of carbohydrate and a small portion of fat.
15871936|NCT03866707|Other|One-time blood draw|"Subjects will have a one-time blood draw of 5-10mL. Quantity of blood drawn for study and routine care will not exceed the maximum safe blood volume for subject size.
~Evaluation of CpG methylation sites will be completed using the MethylationEPIC BeadChip (Infinium) microarray. This covers over 850,000 CpG methylation sites and is available in the investigator's Genomics Core Facility. Dr. Langefeld has analyzed numerous methylation studies, both array-based and next generation sequencing.
~Metabolomic analysis will be performed by mass spectrometry when funds are available."
15871937|NCT03866707|Other|Evaluation of CpG methylation|Evaluation of CpG methylation sites will be completed using the MethylationEPIC BeadChip (Infinium) microarray.
15871938|NCT03866707|Other|Metabolomic analysis|Metabolomic analysis will be performed by mass spectrometry when funds are available.
15871939|NCT03866694|Behavioral|BRIGHT|Dyadic therapeutic parenting intervention (BRIGHT) beginning in third trimester of pregnancy through six months postpartum focusing on child-parent relationship, mental health, infant social-emotional development, and recovery. Monthly handouts for mothers in recovery with information about child development and recovery from substance misuse while parenting and the standard of care at participant's high risk maternal-fetal medical clinic.
15871940|NCT03866694|Other|STAR/TAU+|Monthly handouts for mothers in recovery with information about child development and recovery from substance misuse while parenting and the standard of care at participant's high risk maternal-fetal medical clinic
15872357|NCT03863418|Other|placebo|placebo
15871941|NCT03866681|Drug|sirolimus|The dose of sirolimus is adjusted according to monitored serum concentration, maintain Rapamycin concentration ranging from 4 to 10ng/ml.Warfarin was administered orally at a dose of 1mg per day for a year,then gradually reduced to stop.
15871942|NCT03866668|Drug|Esomeprazole|Esomeprazole Dosage (Weight Less Than 20 kg) -- 10 mg QD for 8 weeks Esomeprazole Dosage (Weight 20 kg or Greater) -- 10 mg QD for 4 weeks followed by 20 mg QD for 4 weeks
15871943|NCT03866655|Device|OWise|OWise Breast Cancer is a supportive care digital tool for breast cancer patients. The tool can be accessed as a mobile phone application or as a website. The tool has various tools for self-managing and self-monitoring treatment and symptoms such as an appointment calendar, a symptom-tracker, a modifiable question list and a recording device for consultations.
15871944|NCT03866642|Device|Cadence Total Ankle Replacment|Cadence Total Ankle prosthesis
15871945|NCT03866629|Drug|Lifitegrast|Lifitegrast ophthalmic solution 5%
15871946|NCT03866616|Behavioral|Brain Builders Parenting Class|Brain Builders Parenting Class group sessions goal is to increase parental knowledge of brain development and increase responsive parenting
15871947|NCT03866616|Behavioral|Control (Usual care)|"This arm receives usual care (control group) consisting in: WIC participants will attend their usual appointments completed at the WIC clinics."
15871948|NCT03866577|Biological|Biological: M254|M254 administered as intravenous infusion
15871949|NCT03866577|Drug|Placebo|Placebo administered as intravenous infusion
15871950|NCT03866577|Biological|Intravenous immunoglobulin (IVIg)|IVIg administered as intravenous infusion
15871951|NCT03866564|Diagnostic Test|Echocardiography|Cardiac ultrasound to measure left ventricular systolic function.
15871952|NCT03866564|Diagnostic Test|Neuropsychological Testing|Standard clinical testing designed to establish or exclude the presence of cognitive dysfunction.
15871953|NCT03866564|Diagnostic Test|Quantitative Sensory Testing|Clinically accepted quantitative assessment of chronic pain burden.
15871954|NCT03866564|Diagnostic Test|Nocturnal Polysomnography|Routine overnight sleep study to measure apnea-hypopnea index.
15871955|NCT03866551|Device|Reprieve Cardiovascular System|The Reprieve Cardiovascular System (RCS) shall be utilized to maximize fluid removal over a maximum duration of 72 hours.
15871957|NCT03866525|Biological|OH2 injection, with or without irinotecan or HX008|OH2: Oncolytic Type 2 Herpes Simplex Virus Irinotecan: cytotoxic agent HX008: anti-PD-1 antibody
15871958|NCT03866512|Behavioral|Forearm immobilization|Two days of forearm immobilization
15871959|NCT03866499|Drug|BPI-7711|180 mg, oral, QD
15871960|NCT03866499|Drug|Gefitinib|250 mg, oral, QD
15871961|NCT03866499|Drug|Placebo Tablet|250 mg gefitinib placebo tablet, QD
15871962|NCT03866499|Drug|Placebo capsule|180 mg BPI-7711 placebo capsule, QD
15871963|NCT03866473|Device|Retilux|670nm wavelength light
15871964|NCT03866473|Device|Sham Light Device|Broad spectrum light device
15871965|NCT03866460|Diagnostic Test|Distortion product otoacoustic emission measurement (DPOAE)|Hearing will be measured at baseline and 3-9 months after completion of treatment with IA carboplatin chemotherapy.
15871966|NCT03866447|Drug|Vitamin D analog|Patients will be clinically and photographically evaluated at baseline and at each follow up visit every month for 3 months. Any local or systemic clinical side effects of the medications will be noted during each follow up visit.
15871967|NCT03866447|Drug|Adapalene|Patients will be clinically and photographically evaluated at baseline and at each follow up visit every
15871968|NCT03866434|Drug|SPD422|Participants will receive 1 mg of SPD422 (2*0.5 mg) capsule orally on Day 1 and 8 in fasted state.
15871969|NCT03866434|Drug|Omeprazole|Participants will receive 40 mg of Omeprazole orally once daily on Days 2 - 8.
15871970|NCT03866421|Diagnostic Test|MR spectroscopy of the liver|Magnetic resonance spectroscopy of the liver. Golden standard for non-invasive determination of NAFLD
15871971|NCT03866421|Diagnostic Test|Fibroscan of the liver|Transient Elastography for Measurement of liver fibrosis.
15871972|NCT03866421|Device|Continuous glucose monitoring (CGM) for four days.|CGM is attached to the abdominal skin for four days. Afterwards data is converted and analysed in a computer program.
15871973|NCT03866421|Diagnostic Test|Oral glucose tolerance test (OGTT)|OGTT with incretin hormones. Measured for three hours.
15871974|NCT03866421|Diagnostic Test|Intra venous glucose infusion (IIGI)|This test is combined with the OGTT to compare responses of parenteral vs enteral stimulation. The test is followed by a bolus of 5 g of L-arginin.
15871975|NCT03866421|Radiation|Dual Energy X-ray Absorptiometry (DEXA) scan|DEXA-scan of the body composition.
15871976|NCT03866421|Biological|Blood samples|Immediately analyse of basic lab data. Later analyses for glucagon, amino acids, bile acids, lipidomics and metabolomics.
15871977|NCT03866421|Other|Clinical and demographic data|Measurements of blood pressure, pulse, height, weight.
15871978|NCT03866408|Behavioral|Immediate weight loss|Upper body obese subjects will undergo behavioral intervention with a life coach and a physical activity program of their choice for 4 months.
15871979|NCT03866408|Drug|Pioglitazone|Upper body obese subjects will be block randomized to pioglitazone or placebo at enrollment.
15871980|NCT03866408|Behavioral|Deferred weight loss|Upper body obese subjects will complete a weight-stable period of 4 months and subsequently undergo behavioral intervention with a life coach and a physical activity program of their choice for 4 months.
15871981|NCT03866408|Drug|Placebo|Upper body obese subjects will be block randomized to pioglitazone or placebo at enrollment.
15871982|NCT03866395|Drug|Ivabradine|Ivabradine 5 mg twice a day
15871986|NCT03866369|Drug|Moxifloxacin|Single oral dose at D-8
15871987|NCT03866369|Drug|Placebo|Single oral dose at D-1
15871988|NCT03866369|Drug|Lanifibranor|Single daily oral dose during 14 days
15871989|NCT03866369|Drug|Placebo|Single daily oral dose during 14 days
15871990|NCT03866356|Behavioral|intervention group|The women in the intervention group were provided care according to SICP
15872600|NCT03861507|Device|Prostate Brachytherapy|High dose - rate (HDR) brachytherapy
15871991|NCT03866343|Other|Diet low or high in advanced glycation endproducts|All subjects will undergo an intervention consisting of a prescribed diet containing either a low or high quantity of AGEs during 4 continuous weeks.
15871992|NCT03866330|Biological|Intraarticular injection of WJMSC|ultrasound guided intra-articular injection of at least 10 million of Wharton's jelly-derived mesenchymal stem cells per procedure
15871993|NCT03866317|Drug|Secukinumab|All subjects will receive secukinumab 300 mg injections subcutaneously at week 0, 1, 2, 3, 4, then every 4 weeks until week 12.
15871994|NCT03866304|Device|Device: S2 Picosecond laser|Each subject will receive up to 16 laser treatments.
15871995|NCT03866291|Other|No intervention, observational|See above
15871996|NCT03866265|Dietary Supplement|Food Grade Extract of Salmon Polar Lipids (FGE-Salmon-PLs)|Each participant will be administered per day a capsule of the FGE-Salmon-PLs food supplement (containing 0.125 g of FGE-Salmon-PLs) for a period of 28 days in a double blind randomized, crossover and placebo-controlled design.
15871997|NCT03866265|Other|Placebo|Each participant will be administered per day a placebo capsule (containing 0.125 g of glycerin) for a period of 28 days in a double blind randomized, crossover design.
15871998|NCT03866252|Drug|LSD|LSD administration per os
15872003|NCT03866213|Diagnostic Test|BiliSpec|BiliSpec will quantitatively measure the bilirubin content of a neonatal blood sample.
15872004|NCT03866200|Drug|resveratrol|125 mg/day or 5 ml once per day for 90 days
15872005|NCT03866200|Drug|Placebo|5 ml once per day for 90 days
15872006|NCT03866187|Biological|ChAd155-hIi-HBV low dose formulation|Subjects in group A1 receive one dose of ChAd155-hIi-HBV low dose formulation at Day 1, by intramuscular injection in the deltoid of the non-dominant arm.
15872007|NCT03866187|Biological|ChAd155-hIi-HBV high dose formulation|"Subjects in groups B1 and B3 receive one dose of ChAd155-hIi-HBV high dose formulation at Day 1 and Day 113 respectively, by intramuscular injection in the deltoid of the non-dominant arm.
~Subjects in groups C1 and C2 receive one dose of ChAd155-hIi-HBV high dose formulation at Day 1 and Day 113 respectively, by intramuscular injection in the deltoid of the dominant arm."
15872008|NCT03866187|Biological|HBc-HBs/AS01B-4 low dose formulation|Subjects in group A1 receive two doses of HBc-HBs/AS01B-4 low dose formulation, one at Day 113 and one at Day 169 and subjects in group A2 receive four doses of the low dose formulation, one dose each at Days 1, 57, 113 and 169, by intramuscular injection in the deltoid of the non-dominant arm.
15872009|NCT03866187|Biological|HBc-HBs/AS01B-4 high dose formulation|Subjects in group B1 receive two doses of HBc-HBs/AS01B-4 high dose formulation, one at Day 113 and one at 169; subjects in group B2 receive four doses, one dose each at Days 1, 57, 113 and 169; subjects in group C1 receive four co-administered doses at Days 1, 57, 113 and 169 and subjects in group C2 receive two co-administered doses at Days 113 and 169, by intramuscular injection in the deltoid of the non-dominant arm.
15872010|NCT03866187|Biological|MVA-HBV low dose formulation|Subjects in group A1 receive one dose of MVA-HBV low dose formulation at Day 57, by intramuscular injection in the deltoid of the non-dominant arm.
15872011|NCT03866187|Biological|MVA-HBV high dose formulation|"Subjects in groups B1 and B3 receive one dose of MVA-HBV high dose formulation at Day 57 and Day 169 respectively, by intramuscular injection in the deltoid of the non-dominant arm.
~Subjects in group C1 receive three co-administered doses of the vaccine at Days 57, 113 and 169 and subjects in group C2 receive one co-administered dose of the vaccine at Day 169, by intramuscular injection in the deltoid of the dominant arm."
15872012|NCT03866187|Drug|Placebo|Subjects in group A3 receive four doses of placebo, one each at Days 1, 57, 113 and 169 and subjects in group B3 receive two doses of placebo one each at Days 1 and 57, by intramuscular injection in the deltoid of the non-dominant arm. Subjects in group C2 receive 2 co-administered doses of placebo at Days 1 and 57, by intramuscular injection in the deltoid of the dominant and non-dominant arm.
15872013|NCT03866174|Drug|Psilocybin|The psilocybin used in this study is synthetically manufactured in a laboratory and meets quality specifications suitable for human research use. The active drug is encapsulated using a hydroxypropyl methylcellulose (HPMC) capsule and contains 25 mg of psilocybin.
15872014|NCT03866174|Drug|Niacin|The active placebo is encapsulated using a HPMC capsule and contains 100 mg of pharmaceutical grade niacin.
15872015|NCT03866161|Device|Continuous positive airway pressure|Continuous positive airway pressure treatment
15872016|NCT03866148|Device|Reveal LINQ|Insertion of monitoring device called Reveal-LINQ (an implantable loop recorder)
15872017|NCT03866122|Device|NTM Monitoring|NTM and a patient monitor will continuously collect temperature for up to 72 hours. Additionally, Bempu and Thermospot may monitor temperature for up to 72 hours.
15872018|NCT03866109|Drug|Temferon|Genetically modified HSPCs
15872019|NCT03866096|Other|Experimental|The player will perform exercises of balance, stability, and strengthening of the abdomen, back and gluteus. All these exercises will be carried out in first instance on flat surfaces and later on unstable surfaces to increase the difficulty of it. The training will be done in different levels of difficulty, once the participant managed to master the initial level, advance to the next level to complete the three levels of difficulty during the 6 weeks of training. There will be 3 repetitions of each exercise with a duration of one minute and breaks of 30 seconds between each repetition and 2 minutes of rest between exercises. The duration of the intervention of the experimental group will last 20 minutes
15872020|NCT03866096|Other|Control|Neuromuscular training will be applied through balance and stability exercises on both flat and unstable surfaces. There will be 3 repetitions of each exercise with a duration of one minute and breaks of 30 seconds between each repetition and 2 minutes of rest between exercises. The duration of each session of the control group is 10 minutes.
15872990|NCT03858933|Device|eBrainFit Platform|Amygdala regulation with eyes open
15872021|NCT03866083|Drug|Extracorporeal Cytokine hemadsorption therapy|Hemoperfusion will be carried out for one session within 12 hours for all randomized patient using the adsorption columns for Jianfan Biotechnology Co., Zhuhai, China). The hemoperfusion apparatus will be connected in front of the hemodialyzer in series.
15872022|NCT03866083|Drug|Standard Medical Treatment|Standard Medical Treatment
15872023|NCT03866070|Other|Experimental|Two exercises will be done to strengthen the external rotation (using elastic bands): standing with 90 degrees of shoulder abduction and elbow flexion and also in standing with the shoulder in neutral position and the elbow flexed to 90 degrees. Subjects will perform 3 sets of 10 repetitions with the band slightly stretched, at a distance of 0.70 m from the wall. Dumbbell exercises will be performed through 4 exercises: flexion in the horizontal plane of 135º, external rotation in lateral decubitus, horizontal abduction with external rotation, and extension in prone position. There will be 5 repetitions each exercise of 3 seconds each, with 2 minutes of rest between exercises.
15872024|NCT03866070|Other|Control|Two exercises will be done to strengthen the external rotation, using elastic bands. The first, standing, with 90 degrees of shoulder abduction and elbow flexion. The second, also in standing, with the shoulder in neutral position and the elbow flexed to 90 degrees. Subjects will perform 3 sets of 10 repetitions with the band slightly stretched, at a distance of 0.70 m from the wall. The band will be subject to a surface, at an equal distance from the subject's elbow to the ground. The repetitions will last one second in concentric external rotation and two seconds in eccentric external rotation, with a rest of 30 seconds between series.
15872025|NCT03866031|Other|implant-supported mandibular overdenture|The implant-supported overdentures will be placed in immediate functional loading on the same day of implants placement. A direct restorative protocol will be applied to modify the existing prosthesis to implant-supported overdentures.
15872026|NCT03866018|Other|Adapted physical activity|12 sessions of one hour of adapted physical activity.
15872027|NCT03866005|Dietary Supplement|Diabetes Visual Function Study (DiVFuSS) softgels|The adjunctive nutritional supplement will be the multi-component formula used in the Diabetes Visual Function Supplement Study (Western IRB number 1129944 Olympia, WA), containing the macular carotenoids lutein and zeaxanthin, as well as antioxidants (vitamins B1, B12, C, D, E, lipoic acid, coenzyme Q10, resveratrol), omega3 fatty acids (EPA/DHA) and botanical extracts (Pycnogenol™ [patented extract of French maritime pine bark, Pinus pinaster], grape seed and green tea extracts, curcumin).
15872028|NCT03866005|Other|canola oil placebo softgels, 2 per day|Placebo containing canola oil, 2 softgels per day
15872029|NCT03865992|Dietary Supplement|Curcumin|Given capsules for oral administration
15872030|NCT03865992|Other|Placebo|Given capsules for oral administration
15872031|NCT03865992|Other|Nanoemulsion|Given nanoemulsion curcumin PO
15872032|NCT03865992|Other|Quality-of-Life Assessment|Ancillary studies
15872033|NCT03865992|Behavioral|Questionnaire|Ancillary studies
15872034|NCT03865979|Device|Viz RECRUIT|Viz RECRUIT includes the following modules: Viz ICH, Viz VOLUME, Viz VIEW and Viz HUB
15872035|NCT03865953|Drug|LAT8881|LAT8881 oral capsule
15872036|NCT03865953|Drug|Placebo|Placebo oral capsule
15872037|NCT03865940|Drug|Lidocaine|6 mL of 1% lidocaine
15872038|NCT03865940|Drug|Guanfacine|250 mcg
15872041|NCT03865901|Diagnostic Test|Mellitus GCD59 Test|An ELISA for screening for the risk of gestational diabetes
15872042|NCT03865888|Drug|Cyclosporins|Cyclosporins eye drops to be administered in dry eyes
15872043|NCT03865888|Drug|Tacrolimus|Tacrolimus eye drops to be administered in dry eyes
15872044|NCT03865875|Behavioral|Exercise Program|Participants will start the exercise program within 2 weeks of enrollment and will continue until surgery. This program will consist of twice weekly individualized sessions with a trainer.
15872045|NCT03865875|Behavioral|Nutrition Program|Each patient enrolled will undergo nutritional assessment at their initial post-enrollment visit to develop an individualized nutrition plan to be implemented up until when the patient undergoes surgery.
15872046|NCT03865862|Other|Experimental|The athletes will perform an intervention of 4 weeks, with two weekly sessions, in which the intervention will be performed during the training, with these sessions lasting 10 minutes. During the performance of the intervention, they will perform 3 sets of 15 repetitions of squats in a 25º inclined plane, performing the eccentric phase of the squat in a time of 4 seconds, the concentric phase in 3 seconds, and a rest of 15 seconds between series. This intervention will be performed adding 50% of his OR as external load during the first two weeks, 55% of his MR during the third week, and 60% of his MR in the fourth week of the intervention. During the exercise you can help the physiotherapist who will accompany you to perform the concentric phase without load.
15872047|NCT03865862|Other|Control|Intervention of 4 weeks, with two weekly sessions, in which the intervention will be carried out during the training, these sessions having a duration of 10 minutes. During the performance of the intervention, they will perform 3 sets of 15 squat repetitions on a 25º inclined plane, performing the eccentric phase of the squat in a time of 4 seconds, the concentric phase in 3 seconds, and a 15-second rest between series. The subjects of this group will perform the protocol using only their own weight as a load.
15872048|NCT03865849|Device|Cooled radiofrequent treatment|In the cooled radiofrequency group a treatment of 60°C measured at the tip and on average 80°C in the targeted tissue is applied during 150 seconds using the Coolief system.
15872049|NCT03865849|Device|Conventional radiofrequent treatment|In the conventional radiofrequency group a treatment of 80°C at the tip is applied during 90 seconds at each nerve.
15872050|NCT03865836|Biological|ATB200|
15872051|NCT03865836|Drug|AT2221|
15872052|NCT03865823|Procedure|pus sample|A pus sample from the fistula will be taken by the doctor during this first consultation or, failing that, in the operating room before disinfection.
15872079|NCT03865576|Diagnostic Test|Non-invasive ICP measurement|Intracranial pressure will be measured non-invasively using transorbital Doppler ultrasound. Values will be compared to ICP measured by lumbar puncture or implanted ICP sensors
15872143|NCT03865082|Drug|Tilsotolimod|9 doses of Tilsotolimod Intratumoral injection administered as a dose of 8mg at Week 0 Day 1 (7 days prior to the start of Cycle 1), Day 1 and Day 8 of Cycle 1, and on Day 1 of Cycles 2 through 7.
15872053|NCT03865797|Other|Experimental|Each session will last approximately 15 minutes, taking place during 2 days a week, in a period of 4 weeks. The intervention will be done before the training session. The intervention by motor control will consist of the application of a series of Core exercises. The exercises will be carried out with the subjects in different positions of prone, lateral and supine position, for the Core musculature. The exercises will be repeated 10 times each and there will be 8 different exercises: roll up, mermaid, raised crossed, stretch two leg back, shoulder bridge and leg pull up.The intervention will be done before the training session.
15872054|NCT03865797|Other|Control active|Each session will last approximately 15 minutes, taking place during 2 days a week, in a period of 4 weeks. The intervention will be done before the training session. The intervention by motor control will consist of the application of a series of Core exercises. The objective of the application of these exercises is to increase the control of the Core, and therefore improve the stability both central and of members. The exercises will be carried out with the subjects in different positions of prone, lateral and supine position, for the Core musculature. The exercises (13) will be repeated 10 times each and there will be 8 different exercises: roll up, mermaid, raised crossed, stretch two leg back, shoulder bridge and leg pull up.
15872055|NCT03865784|Other|Experimental|The intervention through Core exercises will consist in the application of a protocol of four Core stabilization exercises. This protocol will consist of the following exercises: abdominal plate, bilateral plate, hunting dog and gluteal bridge. The intervention by Kinesiotape will be performed with the subject in a sitting position with both arms relaxed throughout the body, while the physiotherapist will place the bases of the strips without tension, on the sacroiliac joint. Once this is done, proceed to ask the subject to lean forward applying the rest of the strip, except the distal edge, with a tension of between 15 and 25%, finally requesting the subject to rejoin straining the distal base without tension, on the twelfth dorsal spinous process.
15872056|NCT03865784|Other|Control|The intervention through Core exercises will consist in the application of a protocol of four Core stabilization exercises. The objective of the application of the technique based on this type of exercise is to improve muscle strength, endurance and neuromuscular control. This protocol will consist of the following exercises: abdominal plate, bilateral plate, hunting dog and gluteal bridge. The intervention by Kinesiotape will be performed with the subject in a sitting position with both arms relaxed throughout the body, while the physiotherapist will place the bases of the strips without tension, on the sacroiliac joint. Once this is done the tape will be placed without tension and sn movement of the subject.
15872057|NCT03865771|Behavioral|Neuropsychological testing|memory, executive testing, behaviour questionnaire, visual attention,
15872058|NCT03865771|Behavioral|Neuropsychological procedure|Rey auditory verbal learning test, Delayed recall : 1h, 5h, 24h (after one night sleep)
15872059|NCT03865771|Other|Video EEG and polysomnography|Video EEG : 10 electrodes + 3 electrodes for PSG 2h wake EEG Whole night EEG
15872060|NCT03865758|Device|IN2L computer system|Therapists will use the IN2L computer system to choose videos, music, games and exercise specific to the rehabilitation needs and personal preferences of patients.
15872061|NCT03865745|Dietary Supplement|Korean Red Ginseng|Take one pack of the product (3g) once a day for 24 weeks
15872062|NCT03865732|Drug|Ganaxolone|active drug
15872063|NCT03865732|Drug|Placebo|inactive
15872064|NCT03865719|Behavioral|Healthy Habits for Life|Healthy Habits for Life: 11-session, 6 month, one-on-one, dietician-lead weight management manualized treatment.
15872065|NCT03865706|Drug|Inulin Oral Suspension|Inulin powder, derived from chicory root and re-suspended in 250cc water Dosage will be either 8g twice a day or 16g twice a day - dissolved in 250cc sterile water, given oral or via enteric tube
15872066|NCT03865706|Drug|Placebo Oral Suspension|250cc sterile water alone, given twice daily a sweetener is added to the water to create identical flavor
15872067|NCT03865706|Drug|Broad-spectrum antibiotics|Standard of care treatment for infections
15872068|NCT03865693|Device|scarmbler therapy|Scrambler therapy is a patient-specific electrocutaneous nerve stimulation device.
15872069|NCT03865680|Drug|CPP-ACP|The fluoride varnish applications will be applied with identical intensive protocols every 2 weeks for 6 weeks. The application of will be according to manufacturer's instructions.
15872070|NCT03865680|Drug|Duraphat|The fluoride varnish applications will be applied with identical intensive protocols every 2 weeks for 6 weeks. The application of will be according to manufacturer's instructions.
15872071|NCT03865667|Device|PROFEMUR® Preserve Femoral Stem|Total Hip Total Hip Arthroscopy
15872072|NCT03865654|Other|Communication Tool|Summarizes recommendations for clinicians and patients for surveillance mammography and follow-up care for breast cancer survivors
15872073|NCT03865641|Device|Virtual reality rehabilitation|Task-specific training has been shown to be more effective when tasks were ordered in a random practice sequence using repetition and positive feedback. VR is an interactive and enjoyable intervention. VR creates a virtual rehabilitation scene in which the intensity of practice can be systemically manipulated.
15872074|NCT03865615|Drug|Oxytocin|intranasal oxytocin 40IU/mL
15872075|NCT03865615|Drug|Placebo|Placebo
15872076|NCT03865602|Behavioral|Sepsis Transition And Recovery (STAR)|In the STAR program intervention, a centrally located nurse navigator facilitates the application of four evidence-based core components of post-sepsis care (i.e., review of medications, new impairments, comorbidities, and palliative care) to patients prior to and during the 30 days after hospital discharge. The STAR navigator will provide telephone and EHR-based support within the hospitalization and to patients across all discharge settings with remote monitoring at specified intervals following hospital discharge. Patients will continue to receive STAR directed services for 30 days following their discharge and then will be transitioned back to the next appropriate care location.
15872077|NCT03865602|Behavioral|Usual care|Patients and their providers will not have access to the STAR program. Patients will continue to receive usual care throughout their stay and discharge, consisting of: patient education and follow-up instructions at discharge, which are not specific to sepsis; routine recommendations for follow-up visits with primary care providers; arrangements for home health services or care management follow-up based on each patient's needs but not specifically tailored to the sepsis population; discharge to post-acute setting with no sepsis-specific follow-up. All aspects of usual care will be determined by treating clinicians independent of trial assignment.
15872080|NCT03865563|Drug|Retrograde venous infusion of gemcitabine/lipiodol|Access will be gained into the portal vein via a transhepatic approach. The pancreatic tumor-draining veins will be accessed via a catheter positioned in the portal vein, superior mesenteric vein or splenic vein. The catheter is then advanced into the vein draining the segment in which the targeted tumor is located. Tumor location and its venous drainage will be confirmed with sub-selective pancreatic venography and cone-beam CT. Once correct catheter positioning is confirmed, the gemcitabine/Lipiodol® emulsion will be administered under real-time fluoroscopic guidance until the entire dose is administered or until stasis is achieved in the vein through which the drug is being delivered.
15872081|NCT03865550|Drug|Isotonic saline|Placebo
15872082|NCT03865550|Drug|Ketamine Injectable Solution|Active comparator
15872083|NCT03865537|Procedure|Cold snare EMR|Participants will have their large polyp removed without electrocautery
15872084|NCT03865537|Procedure|Hot snare EMR|Participants will have their large polyp removed with electrocautery
15872085|NCT03865537|Procedure|Eleview injection|Participants will have their polyp submucosally injected with Eleview
15872086|NCT03865537|Procedure|Placebo injection|Participants will have their polyp submucosally injected with placebo
15872087|NCT03865524|Device|Total knee arthroplasty implanted with GPS navigation system|Obese patients undergoing Total Knee Arthroplasty, GPS achieved alignment
15872088|NCT03865524|Device|Total knee arthroplasty implanted with standard guides.|Obese patients undergoing Total Knee Arthroplasty, alignment achieved by using standard guides
15872089|NCT03865511|Drug|TAGRISSO® 80mg (Osimertinib)|Oral administration of TAGRISSO® 80mg (Osimertinib) as a single daily dose until disease progression or unacceptable toxicity.
15872090|NCT03865511|Genetic|Tumor biopsies|"Tumor biopsies performed at baseline and clinical progression will be processed (fixed) on site, and sent to Nantes University Hospital for analysis.
~The following analysis will be performed:
~Analyses performed on a regular basis, in order to allow subsequent inclusion in other clinical trials :
~C797S testing (digital PCR)
~MET amplification (dPCR/FISH)
~Histological examination of the tissue sample (to identify small cell transformation)
~Expression of proteins by immunohistochemistry: PD-L1 (Ventana SP263 antibody); CD73 ; CD4; CD8.
~At the end of inclusions, deep sequencing analysis to identify acquired mutations and copy number variations (amplifications)."
15872091|NCT03865511|Genetic|ctDNA analysis|"ctDNA analysis by Collection of plasma (two 10-ml Streck tubes) at each time point indicated in the trial.
~These samples will be sent at room temperature by courier to the central laboratory (Nantes University Hospital). There they will be centrifuged, and plasma will be frozen (-80°C).
~Analyses :
~Detection of the EGFR activating mutation in plasma at baseline By dPCR (characterization of patients enrolled)
~Detection of the EGFR activating mutation at d7 and m1 by dPCR (early detection of response to osimertinib)
~Analysis of the plasma samples collected at clinical progression in order to identify acquired mechanisms of resistance by NGS (and comparison with analysis of the biopsies).
~Kinetics studies of the alterations"
15872092|NCT03865498|Behavioral|Twitter for Hispanic caregivers|This group will be asked to follow and use (i.e., retweet, reply, like) our Hispanic Twitter network for social support
15872093|NCT03865498|Behavioral|Twitter for African American caregivers|This group will be asked to follow and use (i.e., retweet, reply, like) our African American Twitter network for social support.
15872094|NCT03865485|Behavioral|Parenting for Lifelong Health (PLH)|The Parenting for Lifelong Health (PLH) initiative is focused on the development, evaluation, and dissemination of parenting programs to reduce violence against children and improve child wellbeing in LMIC. It was established to address the need to develop low-cost, evidence-based parenting programs that can be integrated within existing service delivery systems in LMIC. The PLH for Young Children from 2-9 y. (PLH 2-9) program includes general content like one-on-one time/child-led play; praising and rewarding children; instructions, household rules, and routines; managing difficult behaviours: ignore and consequences; reflection and moving on. Core activities during sessions include group discussions illustrated vignettes, role-plays, collaborative problem solving, practicing skills at home.
15872095|NCT03865472|Other|Questionnaire Administration|Ancillary studies
15872096|NCT03865472|Procedure|Repetitive Transcranial Magnetic Stimulation|Undergo rTMS
15872097|NCT03865472|Procedure|Sham Intervention|Undergo sham rTMS
15872098|NCT03865459|Other|Video group|Patients in the video group started to watch the relaxing video about 5-10 minutes before cystoscopy, and continued to watch video during the whole procedure.
15872099|NCT03865446|Drug|Dacomitinib|anti-cancer agent
15872100|NCT03865433|Other|Aerobic Exercise|Sub-symptom threshold aerobic exercise at a dose of 30 minutes per day, five days per week.
15872101|NCT03865433|Other|Placebo/Stretching|A detailed, progressive stretching program to be performed for approximately 20-30 minutes per day, five days per week
15872102|NCT03865407|Drug|Allopurinol|Allopurinol dosed to target uric acid levels of 3-5 mg/dL.
15872103|NCT03865394|Biological|Application of allogeneic ADSC stem cells in fibrin gel|Chronic wounds in diabetic foot ulcer will be covered with ADSC suspended in fibrin gel - single dose will be administered followed by weekly wound control.
15872104|NCT03865394|Procedure|Standard care in diabetic foot ulcer|Chronic wounds in diabetic foot ulcer will be covered with fibrin gel followed by weekly wound control.
15872105|NCT03865381|Device|Onduo App|The Onduo App is a software application which tracks data relevant to diabetes care, such as, but not limited to, medication, meal logs and glucose readings, and activity data. The Onduo App connects wirelessly to a Care Team Console through the Internet. The Onduo App may also connect wirelessly to commercially available FDA-regulated (i.e., cleared and approved) medical devices and non-medical devices through the subject's Smartphone.
15872106|NCT03865368|Other|Whole Body Vibration Training|Whole Body Vibration Training (WBVT) method has been used as an alternative to conventional strengthening exercises. In this method, the patient stands on the platform of the WBVT device in a static position or performs dynamic exercises, the mechanical vibration produced by the device is transferred to the body
15872107|NCT03865355|Other|Non- interventional|Translational, observational study
15872141|NCT03865108|Procedure|Ultrasound imaging|This standard of care procedure is being done for research purposes and used to collect information and measure the maternal and fetal anatomy.
15872142|NCT03865108|Procedure|Cervical speculum examination|This standard of care procedure is being done for research purposes and used to collect tissue and measure the strength and stiffness of cervix.
15872108|NCT03865342|Behavioral|Noom Coach DPP|Subjects receiving the smartphone app will receive the DPP core curriculum for 16 weeks and then the post-core curriculum for 36 weeks through the app. The Noom mobile app allows secure patient monitoring through a participant dashboard that the coach can use to increase patient adherence and motivation to achieve DPP goals. The participant can log their food intake, weight, steps, exercise, in addition to participating in the DPP group interaction through the application.
15872109|NCT03865329|Behavioral|Intervention- Home-based Pulmonary Rehabilitation|Home-based Pulmonary Rehabilitation (PR) with health coaching using a remote system that will allow patients to complete PR at home. The program involves upper and lower extremity exercises, self-report of symptoms (fatigue, breathlessness, physical activity and overall well-being).
15872110|NCT03865316|Device|SedLine Vs Comparator Test Group|Subjects will receive electrodes that compare EEG signals between Masimo's SedLine system and the comparator's system.
15872111|NCT03865290|Drug|Ondansetron 8mg|Oral Ondansetron 8 mg
15872112|NCT03865290|Drug|Placebo|Oral matched placebo
15872113|NCT03865277|Radiation|dose-escalated radiochemotherapy|"Patients will receive simultaneous radiochemotherapy, however the simultaneous chemotherapy is standard and not part of the evaluation in this trial. Present standard chemotherapy is cisplatinum 40 mg/m²/week (chemotherapy over the whole course of radiotherapy).
~Radiotherapy is applied to doses of 54 Gy(RBE)/ 1.8 Gy(RBE) per fraction to the adjuvant region, 70 Gy(RBE)/ 2 Gy(RBE) per fraction to the tumor and involved lymphonodes and, if hypoxic and randomized to the intervention arm, 77 Gy(RBE)/ 2.2 Gy(RBE) per fraction to the primary tumor and lymphonode metastases > 2 cm.
~Radiotherapy is always applied with 5 fractions per week."
15872114|NCT03865277|Radiation|dose-escalated radiochemotherapy with carbon ion boost|"Patients will receive simultaneous radiochemotherapy, however the simultaneous chemotherapy is standard and not part of the evaluation in this trial.
~Radiotherapy is applied to doses of 54 Gy(RBE)/ 1.8 Gy(RBE) per fraction to the adjuvant region, 70 Gy(RBE)/ 2 Gy(RBE) per fraction to the tumor and involved lymphonodes and, if hypoxic and treated in the study site Heidelberg, 77 Gy(RBE)/ 2.2 Gy(RBE) per fraction to the primary tumor and lymphonode metastases > 2 cm using a carbon ion boost.
~Radiotherapy is always applied with 5 fractions per week."
15872115|NCT03865277|Radiation|standard radiochemotherapy|"Patients will receive simultaneous radiochemotherapy, however the simultaneous chemotherapy is standard and not part of the evaluation in this trial. Present standard chemotherapy is cisplatinum 40 mg/m²/week (chemotherapy over the whole course of radiotherapy).
~Radiotherapy is applied to doses of 54 Gy(RBE)/ 1.8 Gy(RBE) per fraction to the adjuvant region and 70 Gy(RBE)/ 2 Gy(RBE) per fraction to the tumor and involved lymphonodes.
~Radiotherapy is always applied with 5 fractions per week."
15872116|NCT03865264|Other|Recovery Enhancement Program|Behavioral, nutritional, physical and opioid-reduction pain medication
15872117|NCT03865251|Device|Kinesiology tape|Application for 0%, 50%, and 100% of maximal KT stretch to the calf muscle during lying and standing positions
15872118|NCT03865238|Biological|EV71vac|Subjects are to receive a 0.5 mL IM injection of EV71vac. Study drug is administered on Day 1 and Day 57 of the study. Subjects 2 months to < 2 years of age will receive a booster vaccination on Day 366.
15872119|NCT03865238|Biological|Placebo|Subjects are to receive a 0.5 mL IM injection of placebo. Study drug is administered on Day 1 and Day 57 of the study. Subjects 2 months to < 2 years of age will receive a booster vaccination on Day 366.
15872120|NCT03865225|Other|Biofeedback|9 x 10 minutes biofeedback sessions over period of three days
15872121|NCT03865225|Other|Sham-Biofeedback|9 x 10 minutes sham-biofeedback sessions over period of three days
15872122|NCT03865212|Drug|Recombinant Vesicular Stomatitis Virus-expressing Interferon-beta and Tyrosinase Related Protein 1|Given IT and IV
15872123|NCT03865199|Behavioral|Narrative Intervention|"Participants in the intervention group will first view a digital story on a tablet with headphones that will combine a fictional patient's abortion story with basic medical and social facts regarding abortion. After viewing the narrative, participants will be asked to write a narrative either on a tablet provided or on paper with the prompt: Patients have different thoughts and feelings about their experiences when they have this procedure. Tell a story (about yourself or someone else, real or imaginary) that might help another patient feel supported."
15872124|NCT03865186|Behavioral|Psychoeducation Program|"The program titled, Psychoeducation Program for Emotion Identification and Expression in Those Diagnosed with Schizophrenia was conducted with the patients in the intervention groups once a week for ten weeks."
15872125|NCT03865186|Behavioral|no intervention|
15872126|NCT03865173|Other|Telephone Interview|Telephone Interview
15872127|NCT03865160|Drug|Atropine eye drops, 0.01%|One drop of the above mentioned drug will be installed into each at bedtime.
15872128|NCT03865160|Drug|Placebo (NaCl 0.9%) eye drops|One drop of the above mentioned placebo will be installed into each at bedtime.
15872129|NCT03865147|Drug|Tri-Solfen Gel (Lidocaine HCl, Bupivacaine HCl, Adrenaline Acid Tartrate /Cetrimide)|Investigational Drug
15872130|NCT03865147|Drug|EMLA cream|Active Comparator
15872131|NCT03865147|Drug|Post Operative Analgesia (Paracetamol, Ibuprofen)|Standard of Care
15872132|NCT03865134|Diagnostic Test|Snellen Test|Visual acuity measurement
15872133|NCT03865134|Diagnostic Test|Autorefractometer|Refraction measurement
15872134|NCT03865134|Diagnostic Test|Titmus Stereo Fly Test|Stereopsis measurement
15872135|NCT03865134|Diagnostic Test|Optical Kohlerans Tomography|Retinal development measurement
15872136|NCT03865134|Behavioral|Investigation of Visual Motor Integration|Investigation of visual motor integration, motor coordination and visual perception by Beery- Buktenica Developmental Test of Visual Motor Integration.
15872137|NCT03865134|Behavioral|Peabody Developmental Motor Scales - II|Evaluation of motor development
15872138|NCT03865134|Behavioral|World Health Organization Quality of Life - BREF|Assesment of quality of life
15872139|NCT03865134|Behavioral|State - Trait Anxiety Inventory|Assesment of anxiety
15872140|NCT03865121|Drug|Nicotine Nasal Spray 10 MG/ML (0.5 MG/SPRAY)|Patients will receive incremental doses of Nicotine Nasal Spray 10 MG/ML (0.5 MG/SPRAY) starting with 3 bilateral puffs per day (3 mg total) for 3 days, followed by 5 bilateral puffs per day (5 mg) for 3 days, followed by 8 bilateral puffs per day (8 mg) for 4 days, followed by 10 bilateral puffs per day (10 mg) for 10 days.
15872144|NCT03865082|Drug|Nivolumab|Specified dose on specified days.
15872145|NCT03865082|Drug|Ipilimumab|Specified dose on specified days.
15872146|NCT03865069|Other|Mode of ventilation (Volume Guarantee)®|This is a volume-targeted mode of ventilation aimed at delivering the set tidal volume of gas by automatically adjusting the peak inspiratory pressure (PIP) on a breath-by-breath basis. Theoretically this should minimise variation in tidal volume delivery as lung compliance and the infant's condition changes. This function is achieved by an automated servo-controlled mechanism. The upper PIP limit can be set by the clinician as a safety mechanism.
15872147|NCT03865069|Other|Mode of ventilation (Volume control Ventilation)|Volume-Controlled ventilation (VCV) is a type of 'volume targeted' mode. It aims to target be supported the desired tidal volume by delivering a set volume (chosen by the clinician) irrespective of the underlying lung mechanics. The ventilator will generate whatever peak inspiratory pressure is necessary to deliver this volume. There is constant inspiratory flow pattern (a square flow waveform) and peak volume and inspiratory pressure delivery are achieved at the end of inspiration. During the 'control period' of 12 hours without VG, infants will using VCV A/C (assist control) as is our current clinical standard.
15872148|NCT03865056|Device|Optiflow (High-flow Nasal Cannula)|Optiflow will be applied for 20 minutes
15872149|NCT03865056|Device|Non-invasive Ventilation|non-invasive ventilation will be applied for 20 minutes
15872150|NCT03865030|Device|audiovestibular function|"Hearing test- includes a pure tone audiometry, speech audiometry and discrimination level.
~tympanometry- Includes inserting headphones into the participants ears and computer calculation the compliance of the eardrum.
~otoacoustic emission: Includes headphones insertion and calculation of the inner ear audiological function.
~Video head impulse test.
~- Dizziness handicap inventory questionnaire. questionnaire filled by the participants provides a subjective data regarding the severity of the dizziness."
15872151|NCT03865017|Biological|Regulatory T cells|The trial will be carried out in Alzheimer's disease patients. The investigators will isolate CD4+CD25+ Tregs from these patients, expand and injection.
15872152|NCT03865017|Other|Saline|Saline+cell suspension solution infusion
15872153|NCT03865004|Drug|Paracetamol+Morphine|1gr paracetamol plus 0.1 mg/kg morphine were performed simultanously
15872154|NCT03865004|Drug|Dexketoprofen plus Morphine|Intravenous 75 mg Dexketoprofen plus 0,1 mg/kg morphine were performed simultanously
15872155|NCT03865004|Drug|Placebo plus Morphine|100 cc NaCl plus 0.1 mg/kg morphine were performed simultanously
15872156|NCT03864991|Device|e-device for step count (fit-bit)|Patients in this group will receive fitbit device to count their daily steps and record it into their log books.
15872157|NCT03864991|Behavioral|e-messages for log book|Patients in this group will receive e-messages to maintain their log books as per instruction for blood sugar levels and send back weekly through snap shot.
15872158|NCT03864991|Behavioral|e-messages for log book & fit-bit|Patient in this group will receive e-messages to maintain their log books for blood sugar levels as well as use fitbit device and maintain their log book for daily step count and send back weekly through snap shot.
15872159|NCT03864978|Drug|Rifaximin delayed release 400 mg tablet|Rifaximin delayed release
15872160|NCT03864978|Drug|Placebo|Placebo
15872162|NCT03864939|Drug|dHAM|A dehydrated human amnion membrane (dHAM, 1x3cm) is placed around the neurovascular bundle (NVB) on the left and right side and vesicourethral anastomosis (VUA) during radical retropubic prostatectomy (RRP).
15872163|NCT03864939|Drug|No dHAM|A standard radical retropubic prostatectomy (RRP) without dHAM is performed (Walsh, 2005).
15872164|NCT03864926|Drug|Envarsus XR|"Envarsus XR is FDA approved for the prophylaxis of organ rejection in kidney transplant recipients converted from tacrolimus immediate-release formulations, in combination with other immunosuppressants. Envarsus XR, is designed to deliver tacrolimus more smoothly over the whole day.
~Envarsus XR, a calcineurin-inhibitor immunosuppressant, is available for oral administration as extended-release tablets containing the equivalent of 0.75 mg, 1 mg, or 4 mg of anhydrous tacrolimus USP. Inactive ingredients include hypromellose USP, lactose monohydrate NF, polyethylene glycol NF, poloxamer NF, magnesium stearate NF, tartaric acid NF, butylated hydroxytoluene NF, and dimethicone NF. Tacrolimus is the active ingredient in ENVARSUS XR."
15872165|NCT03864926|Drug|Tacrolimus|Tacrolimus (generic; immediate release) is FDA approved for the prophylaxis of organ rejection in heart, kidney and liver transplant recipients.
15872166|NCT03864913|Drug|Testosterone injection|SQ or IM testosterone injections for pubertal induction of transgender male adolescents. Increasing doses per protocol at 3 month and 6 month follow up.
15872167|NCT03864913|Behavioral|PedsQL questionnarie|Validated Pediatric Quality of Life questionnaire completed by subjects at baseline, 3 month and 6 month study visits.
15872168|NCT03864913|Other|Masculinizing effects questionnaire|Subjects complete self-reported questionnaire at 3 month and 6 month study visits.
15872169|NCT03864913|Other|Medication experience questionnaire|Subjects complete self-reported questionnaire at 3 month and 6 month study visits.
15872170|NCT03864900|Behavioral|The medication adherence intervention|The health belief model based medication adherence intervention comprised two main components: a 60-minute individual face to face instruction and six follow-up telephone calls.
15872171|NCT03864887|Procedure|Oxygen supply of high-low-high procedure|The protocol consisted of 1-hour resting, 3-minute baseline measurement, half-hour measurement at 60% FIO2 (phase I, high oxygen), half-hour measurement at 40% FIO2 (phase II, low oxygen) and half-hour measurement at 60% FIO2 (phase III, high oxygen).
15872172|NCT03864887|Procedure|Oxygen supply of low-high-low procedure|The protocol consisted of 1-hour resting, 3-minute baseline measurement, half-hour measurement at 40% FIO2 (phase I, low oxygen), half-hour measurement at 60% FIO2 (phase II, high oxygen) and half-hour measurement at 40% FIO2 (phase III, low oxygen).
15872173|NCT03864887|Device|Optical monitor for hemodynamic parameter.|Near infrared spectroscopy probes of tow wavelengths were attached on the subjects' foreheat to detect the changes of hemodynamic parameters.
15872174|NCT03864874|Diagnostic Test|Intraoperative intracavitary lung ultrasonography|Ultrasonography on the deflated lung for detection of lung nodules
15872214|NCT03864419|Drug|Cyclophosphamide|Given IV
15872215|NCT03864419|Drug|Vincristine|Given IV
15872216|NCT03864419|Drug|Methotrexate|Given IV
15872217|NCT03864419|Drug|Doxorubicin|Given IV
15872218|NCT03864419|Drug|Doxorubicin Hydrochloride|Given IV
15872175|NCT03864835|Behavioral|Moderate intensity aerobic exercise|Subjects that meet requirements for the exercise arm (12 total) will be required to exercise 30 minutes, five days per week at a moderate intensity (HR target corresponding to 45-55% of their relative VO2max). Each session will be supervised in-person at the Penn State University Fitness Center with an ACSM certified exercise physiologist. This is feasible as Zhang et al.(87) found 66 out of 70 subjects (95%) completed the twelve-month supervised in-person moderate-intensity exercise protocol five-days a week.
15872176|NCT03864822|Device|High-Definition Transcranial Direct Current Stimulation|Device uses an array of electrodes over the scalp, in contact via gel, to provide a weak electrical current.
15872177|NCT03864809|Behavioral|sleep disturbance|we observe sleep disturbance among patients with psoriasis and atopic dermatitis and control group
15872178|NCT03864783|Dietary Supplement|Curcumin (Meriva®)|"Experimental drug:
~Meriva® 500 mg tablet (contains 1 mg curcumin)"
15872179|NCT03864783|Drug|Placebo Oral Tablet|"Placebo:
~Contains same ingredients as Meriva®, apart from curcumin. Similar in appearance to Meriva®."
15872180|NCT03864770|Device|Extracorporeal shock wave therapy|Extracorporeal shock wave therapy is a mechanical sound wave that generates energy by extremely high-frequency vibration to compress the medium. Low-energy extracorporeal shock waves can be used for cell regeneration and pain control therapy; medium-high energy can be used to treat patients with poor bone healing; high-energy can be used to lithotrite. In recent years, extracorporeal shock waves have been applied on the musculoskeletal diseases, such as: epicondylitis, plantar fasciitis, chronic pelvic pain, chronic heel pain syndrome, lymphedema, burns, pressure sores, calcific tendinitis and myofascial pain syndrome. This treatment is a non-invasive and safe treatment.
15872181|NCT03864770|Procedure|General physical therapy|The general physical therapies such as: thermotherapy, straight leg raise (SLR), transcutaneous electrical nerve stimulation (TENS) for treatment on calf muscle.
15872182|NCT03864757|Device|thyroplasty implant|Short-term implantation of thyroplasty implant, VOIS, and evaluation of voice quality and glottal closure. After evaluation, remove VOIS and perform medialization of vocal folds using conventional thyroplasty.
15872183|NCT03864731|Device|Bone conduction device (ADHEAR)|adhesive bone conduction device
15872184|NCT03864718|Procedure|photodynamic therapy|Intralesional 5-aminolevulinic acid gel 2% was directly injected into the fistula. The internal and external orifices were closed. After an incubation period of 2 h, the fistula was irradiated using an optical fibre connected to a red laser (MULTIDIODE 630 PDT, INTERmedic, Spain) operating at 1 W/ cm for 3 min (180 Joules).
15872185|NCT03864705|Diagnostic Test|Measurement of plasma metformin levels|Subjects on chronic metformin therapy will have their plasma metformin levels measured during a regular check-up with glycated hemoglobin assessment.
15872186|NCT03864679|Other|Exercise|Subjects will perform a cycling test with 5 min incremental intensity exercise and 1 h cycling test exercising at a moderate-intensity (load will be selected in incremental intensity exercise).
15872187|NCT03864666|Drug|Cilostazol 100 mg|One Cilostazol 100 mg at 08:00 and another at 20:00, two oral doses (total daily dose of 200 mg)
15872188|NCT03864666|Drug|PMR 200 mg|Two PMR 200 mg at 08:00, single oral dose (total daily dose of 400 mg)
15872189|NCT03864653|Behavioral|MoodGym|"MoodGym is a preexisting Internet-based CBT program that uses interactive content and character-driven narratives to help alleviate symptoms of depression and comorbid anxiety. The program also aims to improve the individual's functioning by promoting the development of skills and strategies to manage depression.
~MoodGym consists of an introduction module, five structured intervention modules, and a workbook of assessments. Each MoodGym session takes place entirely on an Internet-connected tablet while in the physical co-presence of a Study Counselor, who can answer questions should they arise. Each session takes approximately one hour to complete."
15872190|NCT03864627|Drug|MOR106|MOR106 liquid formulation for s.c. injection administered concomitantly with TCS (medium potency).
15872191|NCT03864627|Drug|Placebo|Placebo liquid formulation for s.c. injection administered concomitantly with TCS (medium potency).
15872192|NCT03864614|Drug|SAGE-217|SAGE-217
15872193|NCT03864601|Drug|14C-JNJ-56136379|14C-JNJ-56136379 25 mg dose formulated as a polyethylene glycol (PEG)-based oral solution containing 3,145 kilo Becquerel (kBq) of 14C labeled JNJ-56136379, with a maximal total radiation burden of 1,000 micro Sievert.
15872194|NCT03864588|Drug|Ropivacaine|For primary TKA, Ropivacaine is used in both arms, either performed intra-operatively by surgeon or post-operatively (ultrasound guided) by anesthesiologist.
15872195|NCT03864575|Drug|Celecoxib 400 mg|Celecoxib 400 mg/day in combination with nivolumab fixed dose
15872196|NCT03864549|Dietary Supplement|Femina II|2 capsules per day until delivery
15872197|NCT03864549|Other|Placebo|2 capsules per day until delivery
15872198|NCT03864536|Behavioral|Cognitive Prescriptions|Personalized information on their risk factor profile across five CogRx domains (physical activity, cognitive activity, diet, sleep, social activity) and develop a tailored 3-month intervention plan, which will consist of simple evidence-based strategies to implement at home.
15872199|NCT03864523|Drug|Pioglitazone|
15872200|NCT03864497|Procedure|Myocardial perfusion imaging|
15872201|NCT03864484|Device|iPad Application + Usual Rehabilitation|The experimental group receives usual rehabilitation. In addition, the experimental group will watch movies using the iPad application for 3 minutes, once daily for 5 weeks.
15872202|NCT03864484|Behavioral|Usual rehabilitation|The control group receives usual rehabilitation.
15872203|NCT03864471|Other|HCOACDM|The intervention, the HCOACDM, involves case screening, comprehensive assessment, and care coordination, and will be given over a 6-month period.
15872204|NCT03864471|Other|Routine care|The routine care services include home visits, telephone checkups, meals on the wheel, and health promotion activities.
15872205|NCT03864458|Drug|KHK7791|oral administration
15872206|NCT03864458|Drug|Placebo|oral administration
15872207|NCT03864445|Drug|KHK7791|oral administration
15872208|NCT03864445|Drug|Placebp|oral administration
15872209|NCT03864432|Drug|Gemigliptin 25mg|Gemigliptin 50mg 1/2T
15872210|NCT03864432|Drug|Gemigliptin 50mg|Gemigliptin 50mg 1T
15872211|NCT03864432|Drug|Gemigliptin 100mg|Gemigliptin 50mg 2T
15872212|NCT03864432|Drug|Gemiglptin 50mg multiple dose|Gemigliptin 50mg 1T * 10days
15872213|NCT03864419|Biological|Rituximab and Hyaluronidase Human|Given SC
15872226|NCT03864393|Other|Multimodal overground locomotor training|Locomotor training sessions use various movement drills emphasizing power, stability, and stepping in a specific direction: forward, backward, lateral, rotational. Sessions also have an additional focus on gait initiation or steady-state walking. After circuit-style warm up exercises, participants perform overground movement drills that are specific to the emphasis of the individual training session, culminating in practicing everyday overground walking. Participants wear a heart rate monitor to ensure that the majority of the training session is performed at an aerobic intensity greater than 60% age predicted heart rate maximum (220-age +/- 5 bpm).
15872227|NCT03864380|Diagnostic Test|Color retinography|Non mydriatic color retinography within 1 month before and within 1 hour after the marathon
15872228|NCT03864380|Diagnostic Test|OCT-A|Optical Coherence Tomography - Angiography within 1 month before and within 1 hour after the marathon
15872229|NCT03864380|Diagnostic Test|Blood pressure measurement|Blood pressure measurement within 1 month before and within 1 hour after the marathon
15872230|NCT03864367|Device|Device - Prism Medical FGA-700 Bariatric Floor Lift|This group will be using a Mobile Weight-Support Therapy (MWeST) device (the Prism Medical FGA-700 Bariatric Floor Lift) to determine if it improves mobilization of older patients with traumas of their legs.
15872231|NCT03864354|Procedure|Osteopathic Manipulative Treatment|Osteopathic Manipulative Treatment (OMT) is a cost-effective, noninvasive treatment that is used to optimize the body's structure and function. By improving the biomechanical, autonomic, and circulatory mechanisms involved in the disease process of asthma, OMT can help maximize respiratory function. The specific OMT protocol used in this study included the following: supine OA joint myofascial release (MFR), supine cervical spine Still technique, supine thoracic inlet MFR, supine rib raising soft tissue, supine rib MFR, supine abdominal diaphragm MFR, seated thoracic spine Still technique, and seated posterior rib Still technique. Treatments were performed by Predoctoral Osteopathic Manipulative Medicine (OMM) Fellows at Des Moines University (DMU) and supervised and checked by one of two board-certified OMM/NMM physicians from the OMM Department at DMU. The treatment lasted an average of 21 minutes and repeated three times, spaced one week apart.
15872232|NCT03864341|Behavioral|Referral to homelessness prevention services|Referral to Homebase homelessness prevention services offered by community-based organizations in NYC
15872233|NCT03864341|Behavioral|Substance use services|Referral to substance use services (SBIRT and peer counselor/social work contact) available at Bellevue Hospital
15872234|NCT03864341|Behavioral|Follow-up|Follow-up to assist participants in receiving homelessness prevention services
15872235|NCT03864328|Drug|RVT-1601|Inhaled RVT-1601 administered TID via eFlow nebulizer
15872236|NCT03864328|Drug|Placebo|Inhaled Placebo administered TID via eFlow nebulizer
15872237|NCT03864315|Device|HGM|To Study the Efficacy of Therapeutic Pulsed Ultrasound in the Treatment of Vitiligo: a Randomized, Intra-individual, Left-right Comparison Study
15872238|NCT03864302|Behavioral|Motor Imagery|Motor imagery (MI) is a psychological technique for improvement of motor skills.(24) MI skill training (MIST) has been used and explored in several disciplines including Sports, Music, Education, Psychology and Medicine.(18) The literature has found positive effects on performances in professional athletes but also on rehabilitation of stroke patients.(25,26) MI is a cognitive imagery of a physical performance, e.g. a high jumper imagine a high jump, prior to performance. MI is not as effective as physical practice, but more effective compared to no training.(27) Further, MI combined with physical practice has been found to be more effective in skill performance in sports compared to physical practice alone.(18) MIST has shown promising results on surgical performances in flexible cystoscopy performed by doctors.(28)
15872239|NCT03864289|Behavioral|Parent skills training|Parents of children with autism spectrum disorder attend the parental training course once a week, and there was a total of eight courses with each course lasting 3 hours
15872240|NCT03864276|Drug|inhalation (desflurane) group|Anesthesia is induced and maintained with desflurane and sufentanil
15872241|NCT03864276|Drug|total intravenous (propofol) anesthesia|Anesthesia is induced and maintained with propofol and sufentanil
15872242|NCT03864250|Drug|Tacrolimus|The initial dose of TAC is 0.05-0.1 mg/kg/d, taking 2 hours before and after meals. The interval is strictly 12 hours. The blood concentration is measured after taking the drug. According to the concentration of blood drug valley, the dose of tacrolimus (blood concentration of ≤10ng/ml) is adjusted. If the blood drug concentration is low, the drug dose (≤0.1mg/kg/d) is increased accordingly. After 6 months of treatment, the drug is discontinued. The TAC dose is maintained at the original dose after 6 months of treatment with complete or partial remission of urinary protein until the end of the 48-week trial.
15872243|NCT03864250|Drug|Prednisone|The initial dose of prednisone is 0.5 mg/kg/d orally (maximum dose 40 mg/d), and after 8-12 weeks, the dose was gradually reduced until discontinuation. TAC treatment is given at the same time (the treatment plan is the same as the experimental group).
15872244|NCT03864237|Behavioral|Alcohol texts|A text message each day for 10 weeks, containing factual information about campus drinking norms.
15872245|NCT03864237|Behavioral|Attention control|"A text message each day for 10 weeks, containing this day in history facts."
15872246|NCT03864224|Behavioral|GLA:D Back|GLA:D Back is a 10-week program based on first-line recommendations of patient education and structured exercise taught in a group format.
15872247|NCT03864211|Procedure|Thermal ablation|Radiofrequency ablation or microwave ablation is performed under CT or ultrasound guidance for one to five target lesions.
15872248|NCT03864211|Drug|Toripalimab|"Protocol 1. Patients received toripalimab (240mg, Q3W) as monotherapy.
~Protocol 2. Patients received toripalimab (240mg, Q3W) on day 3 after ablation.
~Protocol 3. Patients received toripalimab (240mg, Q3W) on day 14 after ablation."
15872249|NCT03864198|Dietary Supplement|Genante|A dietary supplement for male infertility
15872250|NCT03864185|Biological|Rituximab (genetical recombination)|Administer 375 mg/m2 of rituximab (genetical recombination) IV infusion once weekly for 4 doses.
15872251|NCT03864185|Other|Placebo|Administer placebo IV infusion once weekly for 4 doses.
15872252|NCT03864172|Dietary Supplement|Usual intake + placebo fruit juice|Participants will consume 200 mls of placebo fruit flavoured juice
15872253|NCT03864172|Dietary Supplement|Usual intake+SCF fruit juice|Participants will consume 200 mls of fruit flavoured juice containing 12 g soluble corn fiber (SCF)
15872254|NCT03864172|Dietary Supplement|Adequate calcium + placebo fruit juice|Participants will consume 200 mls of placebo fruit flavoured juice added with 600 mg calcium to meet RNI
15872255|NCT03864172|Dietary Supplement|Adequate calcium+ SCF fruit juice|Participants will consume 200 mls of fruit flavoured juice containing 12 g soluble corn fiber (SCF) added with 600 mg calcium to meet RNI
15872256|NCT03864159|Other|Suction cups|The technique will be performed with the subject sitting on the floor, placing the Foam roller on the back of the thigh, requesting the athlete to perform cranial and caudal movements during the established time. The stretching exercise with the Foam roller will be done during 2 minutes in each member. The intervention through the suction cups will be performed with the subject in prone position, on the stretcher. The suckers are placed in the proximal part where the posterior musculature of the leg originates and in the distal part of the biceps femoris, semitendinosus and semimembranous insertion. This administration of the suckers will be applied during a period of 7 minutes in each member.
15872257|NCT03864159|Other|Foam roller|Each session will last 18 minutes, taking place two days a week, in a period of 4 weeks. The intervention will be carried out before starting the training session. The intervention through the self-administration of Foam roller has the objective of increasing the flexibility of the isquitibial musculature. The technique will be performed with the subject sitting on the floor, placing the Foam roller on the back of the thigh, requesting the athlete to perform cranial and caudal movements during the established time. The stretching exercise with the Foam roller will be done during 2 minutes in each member.
15872258|NCT03864146|Behavioral|Brief Behavioral Compliance Enhancement Treatment|This is a standardized 15-minute intervention that emphasizes medication adherence as a crucial element to change alcohol use behavior.
15872259|NCT03864133|Drug|Omidria|Phenylephrine and Ketorolac infusion of 1%/0.3% during cataract surgery.
15872260|NCT03864094|Drug|Ephedrine|0,1 mg/kg
15872261|NCT03864094|Drug|Phenylephrine|1 microg/kg
15872262|NCT03864094|Drug|Norepinephrine|0,1 microg/kg
15872263|NCT03864094|Drug|Sodium chloride|0,1 ml/kg
15872264|NCT03864094|Drug|Propofol|2 mg/kg
15872265|NCT03864094|Drug|Remifentanil|1,7 microg/kg
15872266|NCT03864068|Other|Placebo|Placebo
15872267|NCT03864068|Drug|Inositol|1gm/bid, 2gm/bid or 3gm/bid of Inositol powder
15872268|NCT03864042|Drug|losartan|taken orally
15872269|NCT03864042|Drug|dextromethorphan|taken orally
15872270|NCT03864042|Drug|caffeine|taken orally
15872271|NCT03864042|Drug|omeprazole|taken orally
15872272|NCT03864042|Drug|midazolam|taken orally
15872273|NCT03864042|Drug|rosuvastatin|taken orally
15872274|NCT03864042|Drug|bupropion immediate release (IR)|taken orally
15872275|NCT03864042|Drug|encorafenib|taken orally
15872276|NCT03864042|Drug|binimetinib|taken orally
15872277|NCT03864042|Drug|modafinil|taken orally
15872278|NCT03864029|Drug|KUVAN|retrospective data on the effectiveness of past treatment with KUVAN®. It includes blood Phe level, physical development status, intelligence development status, etc., during treatment with KUVAN
15872279|NCT03864016|Drug|Induction and maintenance of anesthesia|The hypnotic agent used is Propofol and the morphine agent used is Sufentanil.
15872280|NCT03864016|Drug|Adaptation of sufentanil doses according to the usual protocol|At induction the target concentration of sufentanil is 0.5 ng/ml. The sufentanil dose is decided by the anaesthetist, taking into account the operating times (induction, TIO, incision, opening and sternal spacing, CEC, closure), the usual data provided by the monitoring: heart rate, blood pressure, BIS, EtCO2, modification of insufflation pressures.
15872281|NCT03864016|Drug|Adjustment of sufentanil doses according to pupillometry|At induction, the target concentration of sufentanil is 0.5 ng/ml. The dose of sufentanil is then adjusted according to the dilation reflex obtained with the PPI (Pain Pupillary Index) at predefined times.
15872282|NCT03864003|Behavioral|Community Health Workers and Teleaudiology as a Culturally-Relevant Approach to Improving Access to Hearing Health Care|In this project, remote hearing aid fittings will be delivered by an audiologist with patient-site support from a local facilitator for a cohort of older adults (>50 years) from a rural area that has been identified as under-resourced for hearing health care.
15872283|NCT03863990|Drug|PAH medication|Any PAH-targeted medication
15872284|NCT03863977|Drug|Dexamethasone|After the surgery, dexamethasone added to 1mg/kg of 0.5% bupivacaine in the TAP block.
15872285|NCT03863977|Drug|Bupivacaine|After the surgery,1mg/kg of 0.5% bupivacaine in the TAP block.
15872286|NCT03863964|Diagnostic Test|blood test|13 blood samples will be drawn: at 3 min, 7 min, 15 min, 30min, 1h, 1.5h, 2h, 2.5h, 3h, 3.5h, 4h, 4.5h, and 5h post-treatment with TXA. Blood samples will be processed for ROTEM® analysis and for plasma concentration of TXA. TXA plasma concentrations will be modeled with a non-linear mixed-effects strategy using Monolix 4.1 and NONMEM(®) 7.2.
15872287|NCT03863938|Drug|Tegoprazan 50mg|K-CAB
15872288|NCT03863925|Device|Target controlled infusion, Schnider model|Target controlled infusion (TCI) is an intravenous drug delivery system estimating pharmacokinetics after input of patient's data, e.g. age, sex, body height, body weight. Schnider model is one of TCI model to deliver Propofol. After target concentration at effect site (e.g. the brain) is keyed in, the computerized infusion pump will calculate dosage of bolus and infusion rate for each individual, and calculated concentration of propofol at plasma and brain will be displayed. The clinicians should evaluate the patient's sedation level in response to calculated propofol concentration and titrate target concentration to achieve desired sedation level.
15872289|NCT03863925|Behavioral|Bolus injection of Propofol|Bolus intravenous injection is a traditional way to deliver anesthetic, and the dosage and amount of medication is based on clinical experience and patients' response.
15872290|NCT03863912|Other|Disney movie|Disney movie on portable DVD Player.
15872291|NCT03863912|Other|EORTC QLQ-C30 and EORTC QLQ-FA12 surveys|EORTC QLQ-C30 and EORTC QLQ-FA12 surveys
15872292|NCT03863899|Procedure|Nerve block|drug mixture: 10-15 ml 0.5% ropivacaine plus 5 ml 1% lidocaine plus 1 mg dexamethasone plus 50 ug adrenaline
15872293|NCT03863899|Procedure|Local infiltration|15-20 ml of mixture of 0.5% bupivacaine and 1% lidocaine (1:1)
15872294|NCT03863899|Procedure|TAVI|Insertion of an aortic valve prothesis through the aorta accessed through femoral artery
15872295|NCT03863899|Drug|Additional intraoperative analgesia|Administration of any analgesics during the operation
15872296|NCT03863899|Drug|Additional postoperative analgesia|Administration of any analgesics within first 24 hours after the operation
15872297|NCT03863886|Procedure|Endoscopic ultrasound catheter (UM-2R/3R, Olympus)|A miniprobe ultrasound catheter (UM-2R/3R, Olympus) will be passed into the colonoscope's accessory channel at the time of colonoscopy to measure the thickness of the different colon wall layers (mucosa, submucosa, muscular propria, and total wall thickness) in the cecum and rectum.
15872298|NCT03863873|Procedure|Platelet-Rich Plasma Injection Group|Platelet-Rich Plasma Injection Group
15872299|NCT03863860|Drug|Fluzoparib capsules|Fluzoparib capsules
15872300|NCT03863860|Drug|Placebo capsules|Placebo capsule
15872301|NCT03863847|Procedure|Neurofeedback|The patients will receive neurofeedback on pain related brain-activity, and through training, learn to control said brain-activity.
15872302|NCT03863847|Procedure|Sham|The patients will receive sham neurofeedback on non-pain related brain-activity, and through training, learn to control said brain-activity.
15872303|NCT03863834|Device|InModeRF|InModeRF minimally invasive treatment based on Radiofrequency-assisted lipolysis (RFAL) technology
15872304|NCT03863821|Device|HHHFNC|"HHHFNC setting:
~Flow rate: 40L/min
~FiO2: 0.4
~HHHFNC will use immediately before 6MWT and remove at the end of 6MWT"
15872305|NCT03863808|Behavioral|Cognitive Behavioural Therapy|"Following assessment a one on one session will be given comprising education cognitively targeting false ideas and beliefs on the nature of pain, differentiating nociception due to a painful stimulus and the transition of such a stimulus to a centrally sensitized experience due to misinformation, maladaptive behaviour and fear avoidance. Upon completion of the session assessment using the NPQ will be done to assess the understanding of the patient and further address any shortcomings in future exercise sessions.
~Another SEMG recording of the Flexion Relaxation phenomenon will be upon completion of the educational session and a SEMG biofeedback session will begin to help the patient regain their sense of control over their body and function.
~After the SEMG biofeedback session a graded exposure exercise program of strengthening and functional training starting from the least feared movements to the most over 10 sessions over 5 weeks."
15872306|NCT03863808|Other|Strengthening exercises|Strengthening exercises in a gradual manner to the Multifidus and Transversus Abdominis muscles.
15872307|NCT03863795|Other|Survey Administration|Respond to SurveyGizmo survey online
15872308|NCT03863782|Other|No intervention|No specific intervention. Collection of clinical data
15872309|NCT03863769|Other|Lumbar Spinal Stenosis|Posture and Performance testing: ABC-6 Scale, low back pain NRS, buttock or leg pain NRS, five times sit-to-stand, timed up-and-go, PGIC, eyes open force plate assessment (30 seconds), and eyes closed force plate assessment (30 seconds).
15872310|NCT03863756|Radiation|EOS|The new EOS-technology (EOS imaging, Paris, France) based on a low-dose X-ray system allows 3D modeling of the spine based on 2-dimensional
15872311|NCT03863743|Other|integrated care pathway|Incidence of POUR after undergoing total hip or knee replacement and integrated care pathway will be evaluated.
15872312|NCT03863743|Other|physician's standard of care|Incidence of POUR will be evaluated in standard of care treatment.
15872313|NCT03863730|Dietary Supplement|Profermin Plus, FSMP, probiotics|Participants will have to supply their normal intake with Profermin Plus, FSMP, Prbiotics product twice every day for 24 weeks.
15872314|NCT03863730|Dietary Supplement|Fresubin, dietary supplement|Participants will have to supply their normal intake with the control product, Fresubin, dietary supplement twice every day for 24 weeks.
15872315|NCT03863717|Other|Arm Endurance Exercise Training|Pulmonary Rehabilitation Program including Upper Limb Endurance Exercise Training with arm cycle ergometer
15872316|NCT03863717|Other|Control|Pulmonary Rehabilitation Program without Upper Limb Endurance Exercise Training
15872317|NCT03863704|Device|Transcutaneous Electrical Nerve Stimulation (TENS)|To apply transcutaneous electrical stimulation using a TENS unit to the ear or the leg.
15872318|NCT03863691|Drug|Amisulpride 300 MG|A single dose of 300 mg amisulpride that looks identical to placebo control capsules.
15872319|NCT03863691|Drug|Placebo oral capsule|A placebo capsule with no inert pharmacological effect. Looks identical to the amisulpride capsules.
15872320|NCT03863678|Other|Neurodevelopemental therapy (NDT)|NDT treatment will be given for 45 minutes, 3 sessions per week in 4 weeks period (total of 12 sessions).
15872321|NCT03863678|Other|Neurodevelopemental therapy (NDT) and dry needling|NDT treatment will be given for 45 minutes, 3 sessions per week in 4 weeks period (total of 12 sessions). Dry needling will be applied on M. Gastrocnemius, M.Quadriceps, M.Flexor Carpi Radialis, and M.Biceps Brachii muscles, 60 seconds (sec) for each muscle groups at the end of the NDT treatment.
15872322|NCT03863665|Device|A&D BP Digital Blood Pressure Monitor (UA-767PBT-Ci) CE Declaration UA-767PBT-Ci|Telemetric home monitoring is a promising strategy to facilitate home BP monitoring after stroke, which should improve adherence and optimize medication to better control BP. Telemetry allows patients with hypertension to monitor their own BP and automatically send the information to a secure website, available to their clinicians to monitor and adjust their treatment.
15872323|NCT03863652|Procedure|Percutaneous coronary intervention via snuffbox approach|After local anesthesia on left or right anatomical snuffbox with lidocaine hydrochloride using a 26 gauge needle, the puncture is performed using a 20 gauge needle with the through-and-through puncture technique or a 21 gauge open needle with anterior wall puncture technique. After successful puncture, 0.025-inch straight wire or 0.018-inch hair wire are inserted, followed by an insertion of the 5Fr. or 6Fr radial sheath (Prelude® Radial; Merit medical, UT, USA or Radifocus® Introducer II or Glidesheath Slender®; Terumo Corporation, Tokyo, Japan). The selection of puncture device is at physician discretion.
15872324|NCT03863639|Diagnostic Test|Neuroimaging Procedures|"Subjects will complete neuroimaging procedures at 2-6-week postpartum or during hospitalization after delivery prior to discharge, which will consist of high-resolution anatomic, perfusion and resting-brain fMRI sequences; all of which will be acquired on a 3-Tesla General Electric magnetic resonance scanner
~provided by the Brain Imaging and Analysis Center (BIAC) at Duke University. No contrast agent will be administered in these imaging procedures."
15872325|NCT03863639|Diagnostic Test|Neuropsychological Assessment Procedures|Once identified as meeting study criteria and consented for participation, parturients will be tested during hospitalization or as outpatients for controls, and at 2-6 weeks postpartum with the following cognitive battery. Wechsler Test of Adult Reading (WTAR), CANTABeclipse Computerized Cognitive Assessment Measures, Stroop Color-Word Test, Controlled Oral Word Association Test, EuroQol, Beck Depression Inventory Revised
15884642|NCT03769012|Dietary Supplement|Placebo|microcrystalline cellulose
15872326|NCT03863626|Other|Frusemide IV shots|"giving frusemide by IV shots
~And if developed diuretic resistance (diminishing diuretic effect despite incremental dose of IV loop diuretic), adjuvant oral Metolazone will be given for sequential nephron blockade comparing its administration timed 60 minutes prior to the morning Frusemide shot versus given after. (This will be in a second level of randomization)"
15872327|NCT03863626|Other|Frusemide IV infusion|"giving frusemide by continuous IV infusion
~And if developed diuretic resistance (diminishing diuretic effect despite incremental dose of IV loop diuretic), adjuvant oral Metolazone will be given for sequential nephron blockade"
15872328|NCT03863613|Device|Pessary|A soft, flexible, silicone pessary (Arabin®, Dr Arabin GmbH & Co KG, Germany) will be inserted through the vagina, upward around the cervix.
15872329|NCT03863613|Procedure|Cervical cerclage|Cervical cerclage using Mc Donald technique, under anaesthesia
15872330|NCT03863613|Drug|Vaginal progesterone|Cyclogest® 400mg, Actavis, United Kingdom, applied once daily at bedtime
15872331|NCT03863600|Behavioral|Midwife-led continuity of care|Midwives from governmental hospitals provide antenatal and postnatal case-load-care in rural villages governmental clinics
15872332|NCT03863587|Biological|HLX12|healthy volunters receive HLX12 (8mg/kg) once
15872333|NCT03863587|Biological|Cyramza (Ramucirumab)|healthy volunters receive Cyramza (Ramucirumab) 8mg/kg once
15872334|NCT03863574|Drug|Saroglitazar Magnesium 2mg|Patients randomly assigned to this group will receive Saroglitazar Magnesium 2 mg tablet orally once daily for 24 weeks.
15872335|NCT03863574|Drug|Saroglitazar Magnesium 4mg|Patients randomly assigned to this group will receive Saroglitazar Magnesium 4 mg tablet orally once daily for 24 weeks.
15872336|NCT03863574|Drug|Placebos|Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks.
15872337|NCT03863561|Behavioral|Diabetes self-management education (DSME) program|Diabetes educators customized care paths for their patients based on their individual responses to the SCPI questions. Patients met with an educator five to seven times over the course of three to four months.
15872338|NCT03863548|Other|complication|collection of post-operative bleeding complications
15872339|NCT03863535|Drug|Conbercept|Participants were randomized (1:1) to receive IVC+PRP or PRP monotherapy. Patients in IVC+PRP group with diabetic macular edema (DME) received 3 monthly IVC injections along with standard PRP within 1 week after the first injection. Those without DME received 1 lVC injection and standard PRP within 1 week after the injection . Re-treatments in both groups were at the investigators'discretion.
15872340|NCT03863535|Procedure|Panretinal coagulation|The PRP monotherapy group received standard PRP between day 1 and month 2; thereafter, re-treatments in both groups were at the investigators'discretion.
15872341|NCT03863522|Procedure|Fine needle aspiration|Fine needle aspiration is a type of biopsy procedure to diagnose suspicious lesions. After giving numbing medicine, a thin needle is inserted into the breast to obtain a sample. This procedure is followed by the standard of care and will last about 10 minutes. The sample will be analyzed by a diagnostic cartridge and by the cytopathologist.
15872342|NCT03863522|Device|Cancer Detection cartridge|The Cancer Detection cartridge has the ability to measure methylated gene changes in breast cells. The device will not be in contact with the patients. The FNA samples will be smeared on a slide which will be placed into the cartridge for analysis.
15872343|NCT03863509|Behavioral|Cigarettes|smokes daily
15872344|NCT03863509|Behavioral|E-Cigarettes|E-cigarette usage >/= 5 days/week
15872345|NCT03863496|Procedure|Scoliosis surgery|All patients will be implanted Medtronic CD Horizon Legacy 4.5 and 5.5 under X-ray control (C-arm), intraoperative spinal deformity surgery safety control and standard anesthetic support.
15872346|NCT03863483|Drug|Sintilimab|Sintilimab will be administered intravenously at a fixed dose of 200 milligrams (mg) on Day 1 of each 21-day cycle.
15872347|NCT03863483|Drug|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) will be administered intravenously on Day 1 of each 21-day cycle.
15872348|NCT03863483|Drug|Pemetrexed|Pemetrexed 500 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle.
15872349|NCT03863483|Drug|Placebo|0.9% sodium chloride injection as placebo will be administered intravenously at a fixed dose of 100 milliliters (mL) on Day 1 of each 21-day cycle.
15872350|NCT03863470|Behavioral|Early mobilization intervention|The intervention consists of 3 components: 1) A simplified mobilization goal (using the Surgical Optimal Mobility Score) will be defined during daily morning ward rounds and displayed on the doors of patients' rooms; 2) a facilitator will communicate to the care team regarding mobility goals; 3) clinicians will receive feedback on patient's mobility as mobility scores will be made available electronically on the ICU board - a dashboard for monitoring patient care in the ICU
15872351|NCT03863457|Drug|Fluoroglutamine [18F]F-GLN|Evaluate the kinetics and biodistribution of [18F]F-GLN in primary and metastatic breast cancer.
15872352|NCT03863444|Other|Prenatal Preparation Education|Intervention, provided by researchers, includes video, counseling, and skill practices. Video contains (1) Newborn Reaction, including rooting reflex, correct latch-on posture, assuring newborn having enough milk intakes; (2) Newborn Care, including holding, dipper-changing, clothes-changing, and swaddle the newborn; and (3) Partner Support, including the importance of partner support and the content how partner provide support to the postpartum women. After watching the video, the researcher will provide participants counseling, and then each pair of participants will have skill practice.
15872353|NCT03863444|Other|Routine care|Routine care, provided by clinic nurses, includes antenatal breastfeeding education (i.e., providing education sheet, explaining the benefits and importance of breastfeeding, exclusive breastfeeding for six months, responsive breastfeeding, maintaining milk production, immediately skin-to-skin touch after delivery, and room-in) and demonstration of newborn care (i.e., newborns holding posture, breastfeeding holding posture, and newborn latch-on posture) by pictures and baby models.
15872354|NCT03863431|Other|High-fat diet|"Participants will consume a high fat diet for 14 days with approximately 65% of energy from fat. The diet will also provide an energy excess, at 130% of energy requirements.
~Participants will be provided with all of their meals and snacks throughout the study."
15872355|NCT03863431|Other|High-carbohydrate diet|"Participants will consume a high fat diet for 14 days with approximately 70% of energy from carbohydrate. The diet will also provide an energy excess, at 130% of energy requirements.
~Participants will be provided with all of their meals and snacks throughout the study."
15872356|NCT03863418|Dietary Supplement|Lactobacillus rhamnosus GG|PROBIOTIC
15872358|NCT03863405|Drug|Metformin|metformin 850 mg bid for RA patients with moderate to high disease activity provided by DAS-28 score greater than 3.2
15872359|NCT03863405|Drug|Conventional DMARDs|methotrexate, leflunomide, hydroxychloroquine or sulfasalazine
15872360|NCT03863405|Drug|Placebo Oral Tablet|oral tablet
15872361|NCT03863392|Drug|Misoprostol|induction of labor
15872362|NCT03863379|Diagnostic Test|whole body DXA|Measurements of body composition may be used to study how lean body mass and body fat change during health and disease and have provided a research tool to study the metabolic effects of obesity and various wasting conditions. DXA measurements are based in part on the assumption that the hydration of fat-free mass remains constant at 73%.
15872363|NCT03863366|Drug|Prucalopride|1mg prucalopride tablet, encapsulated in white capsule
15872364|NCT03863366|Other|Placebo|Lactose placebo tablet, encapsulated in white capsule
15872365|NCT03863353|Behavioral|Educational Intervention|This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.
15872366|NCT03863340|Behavioral|interruptions of work tasks|"During each activity two interruptions/breaks were selected randomly from a set of ten predetermined actions:
~Active break types:
~Move shoulder and upper back
~Swing arms near the body
~Three slow but forceful elevations of the shoulders, a relaxation exercise based on the principles developed by Jacobson
~Stand up and stretch
~Slowly turn head in all possible directions.
~Passive break types:
~Tell a couple of jokes
~Stand up and have a drink
~Relaxing the trapezius
~Questions on actual posture and feelings of comfort / discomfort.
~A short rest on the couch"
15872367|NCT03863327|Other|No intervention|There will be no intervention as a part of this protocol.
15872368|NCT03863314|Device|Virtual Simulation|Virtual simulation of workplace-related scenarios of pre-recorded videos using the same actors
15872369|NCT03863314|Other|In-person Simulation|In-person simulation of workplace-related scenarios with live actors
15872370|NCT03863301|Radiation|MR-guided single dose preoperative PBI|A single dose of 20Gy to the gross tumor volume (GTV) is prescribed, to the clinical target volume (GTV + 20mm margin) 15Gy is prescribed.
15872371|NCT03863288|Procedure|fMRI|functional mri (fMRI) scan with affective/cognitive tasks
15872372|NCT03863288|Drug|Oxytocin Intranasal Spray 8IU|Oxytocin intranasal spray liquid administration
15872373|NCT03863288|Drug|Oxytocin intranasal spray 24IU|Oxytocin intranasal spray liquid administration
15872374|NCT03863288|Drug|Oxytocin intranasal spray 48IU|Oxytocin intranasal spray liquid administration
15872375|NCT03863288|Drug|Oxytocin intranasal spray 80IU|Oxytocin intranasal spray liquid administration
15872376|NCT03863288|Drug|Placebo|Placebo intranasal spray liquid administration
15872377|NCT03863275|Device|functional apparatus|The EMG activity will be recorded during different shots: T0. The activity of the muscles of the mastication in the position of clinical rest for a minute, in maximum intercuspidation. (It will be measured with a dynamometer to standardize the force), and with the use of the equipment. T1 The patient's citation is scheduled six months after the use of myofunctional device Sn1 and the test will be performed again measuring electrical activity of right and left masseter and right and left temporal muscle at clinical rest for one minute, in maximum intercuspation, and with the use of the equipment To avoid the effects of fatigue, a rest period of at least 5 minutes between each of the recordings will be allowed
15872378|NCT03863275|Other|Diagnosis and observation|Six months of observation in the control group: patients group the efforts are controlled. to obtain models and have an observation of the molar classification, and to verify if the terms of the inclusion in the study are taken into account, once it is confirmed that the activity is observed in the muscular activity of the chewing muscles, in two stages , at the beginning of the session and six months later. .
15872379|NCT03863249|Procedure|SCALE AND ROOT PLANING|"SRP will be performed two quadrants at a time under local anaesthesia at approximately weekly intervals.
~Each session will be carried out with the following materials: - Ultrasound device (SONICflex 2003 / L) and curettes (Hu-Friedy Manufacturing, Illinois, USA)."
15872380|NCT03863249|Drug|ADJUNTIVE ANTIBIOTICS|"The antimicrobial adjunctive agents selected by 'Echevarne' laboratories analysis will be started at the second SRP visit.
~The antibiotic will be selected among AMOXICILIN, METRONIDAZOLE, AMOXICILIN + METRONIDAZOLE AND AZITROMYCIN."
15872381|NCT03863249|Diagnostic Test|MICROBIAL SAMPLING|"Before treatment, the 10 deepest interproximal sites in each quadrant will be selected and exposed to microbial sampling. Two sterilized paper points will be inserted into the pocket of each site and will be keep in place for 60 s. The twin paper points will be remove and distributed in two vials and transfer for microbiological processing.
~The subgingival microbiota will be harvested from the sampling sites 2 months after the completion of active therapy."
15872382|NCT03863236|Dietary Supplement|regular diet|The control group (group 1) will continue their regular diet.
15872383|NCT03863236|Dietary Supplement|nutritional support Resource 2.5|The intervention group (group 2) will get preoperative nutritional support (Resource 2.5 Compact/fibre combact) two weeks before the operation and the nutritional support will continue 10 days after the operation.
15872384|NCT03863223|Drug|Pyrotinib, Trastuzumab, Docetaxel|Pyrotinib 400mg orally daily until progressive disease
15872385|NCT03863223|Drug|Placebo, Trastuzumab, Docetaxel|Placebo 400mg orally daily until progressive disease
15872386|NCT03863210|Other|"60-minute lecture titled Change of lifestyle and nutrition habits to reduce cardiovascular risk"|"All participants were exposed to the intervention. The intervention consisted of a 60-minute lecture titled Change of lifestyle and nutrition habits to reduce cardiovascular risk. The lecture was delivered in family medicine offices by four specialists of family medicine individually to the groups of 6-8 participants. The lecture was verbal, harmonized among four family physicians, and contained instructions for changing nutrition habits, smoking habits and instructions for increasing physical activity. At the end of the lecture, each participant received a personally tailored decision aid, which included the list of her risk factors, assessment of the 10-year risk of fatal CVD (based on the data provided by the participants before the lecture), and instructions on what she should do in terms of changing the lifestyle habits."
15872387|NCT03863197|Behavioral|Progressive strength training|Progressive Supervised Home-based Strength Training
15872388|NCT03863184|Drug|Acalabrutinib|Acalabrutinib, oral, 100 mg BID, continuous
15872389|NCT03863184|Drug|Lenalidomide|Lenalidomide, 15 mg for cycle 1, then escalated as tolerated to 20 mg, QD, Days 1-21 out of 28 day cycles
15872390|NCT03863184|Drug|Rituximab|Rituximab, IV, weekly during Cycle 1, and every other cycle starting with Cycle 4
15872391|NCT03863171|Diagnostic Test|Arterial spin labeling (ASL) magnetic resonance imaging|Arterial spin labeling (ASL) magnetic resonance imaging test
15872392|NCT03863171|Diagnostic Test|Fundus fluorescein angiography|Fundus fluorescein angiography test
15872393|NCT03863158|Other|No intervention|No intervention / medical records only
15872394|NCT03863145|Drug|CB-03-10|CB-03-10, 100 mg capsule for oral use
15872395|NCT03863132|Device|TAVR|Repair of defective aortic valve by microsurgical Intervention.
15872396|NCT03863119|Drug|Vamorolone|2.0 mg/kg/day, 4.0 mg/kg/day, or 6.0 mg/kg/day at physician discretion
15872397|NCT03863106|Other|Metastatic gastroenteropancreatic and lung neuroendocrine tumors|Patients with metastatic GEP and lung NETs will be selected via the Cancer Database on NEN of the Hospices Civils de Lyon. Data from this database will be matched with the French nationwide claims and hospitalization database (SNDS database), allowing access to the corresponding healthcare resources use and their related costs. Data regarding clinical and tumour characteristics and treatments patterns will be collected via the database between 1 January 1990 and 31 of December 2017.
15872398|NCT03863093|Device|Electro Medical Systems AIRFLOW®|An erythritol powder will be used by Electro Medical Systems AIRFLOW® and then Electro Medical Systems Piezo will be used for supra- and subgingival ultrasonic instrumentation
15872399|NCT03863093|Device|Electro Medical Systems Piezo|Electro Medical Systems Piezo will be used for supra- and subgingival ultrasonic instrumentation
15872400|NCT03863080|Drug|RVT-1401|Subcutaneous administration of RVT-1401
15872401|NCT03863080|Drug|Placebo|Subcutaneous administration of Placebo
15872403|NCT03863054|Device|NATROX™ Topical Oxygen Therapy System|"A small battery-powered electrochemical oxygen generator to concentrate atmospheric oxygen and feed to wound site through a dressing-like oxygen distribution system"
15872404|NCT03863041|Other|Additional sequence performed during MRI scan|An additional sequence will be performed during the MRI scan.
15872405|NCT03863028|Other|Simulation training|It is not a randomized trial - all three groups are exposed to simulation training.
15872406|NCT03863015|Drug|Tocilizumab 20 Mg/mL Intravenous Solution|Tocilizumab is suspended in isotonic saline to a total volume of 100mL prior to infusion
15872407|NCT03863015|Drug|isotonic saline|A one hour infusion of 100mL isotonic saline
15872408|NCT03863002|Biological|Mesenchymal Stem Cell|Mesenchymal stem cell transplantation via peripheral vein: 1.0-10x10^5 MSCs/kg body weight administered via peripheral vein at week 0, 1, 2, 3 weeks
15872409|NCT03862989|Procedure|Radiofrequency catheter ablation|A catheter is inserted into the heart and signals are recorded from the heart whilst at rest or whilst being stimulated by a catheter, in order to determine the site to ablate. Radiofrequency is then delivered to the target site in order to disrupt the pathological electrical activation which is causing the abnormal heart rhythm.
15872410|NCT03862976|Diagnostic Test|computerized cardiotocography|computerized cardiotocography (C-CTG)
15872411|NCT03862963|Behavioral|Standard of diabetes care|The standard of diabetes care consisted of standard treatment protocols used by the MOH Diabetes Clinic. These included placing T2D patients on anti-hyperglycemic agents appropriate to their HbA1c levels (including sulfonylureas, metformin, and insulin) and providing oral and written information about the importance of maintaining a healthy weight, eating a healthy diet, and getting regular exercise. Participants in the control group were instructed not to make changes in their diet and activity levels during the study.
15872412|NCT03862963|Behavioral|Lifestyle Intervention|The lifestyle intervention consisted of a high-fiber, low-fat, mostly plant-based diet and 30-60 minutes per day of culturally-relevant, moderate intensity exercise. Participants initially received 12 weeks of group educational classes and some prepared meals and then followed the lifestyle intervention on their own for the remaining 12 weeks. Group classes included informative sessions on healthy eating, exercise (both aerobic and strength training), and stress management, as well as hands-on cooking classes. Classes were delivered as a combination of PowerPoint presentations, practical workshops, dine-outs, shopping tours, and cooking classes with spouses.
15872413|NCT03862950|Drug|Placebo Medication|Placebo liquid or capsules given in parallel to active medication.
15872414|NCT03862950|Drug|Metformin|Active medication
15872415|NCT03862937|Dietary Supplement|Exercise training + whey protein|Whey protein (2x / day - 20g for breakfast and 20g for dinner).
15872416|NCT03862937|Other|Exercise training + placebo (maltodextrin)|Maltodextrin (2x / day - 20g for breakfast and 20g for dinner).
15872417|NCT03862924|Device|Standardized Research Electronic Cigarette|Participants will receive SREC weekly and eill be encouraged to replace their usual combustible cigarette with the SREC whenever they would normally smoke.
15872418|NCT03862911|Radiation|palliative radiotherapy|Radiotherapy for patients in the standard arm should follow the principles of palliative radiotherapy as per the individual institution, with the goal of alleviating symptoms or preventing imminent complications. Patients in this arm should not receive stereotactic doses or radiotherapy boosts. Recommended dose fractionations in this arm will include 8 Gy in 1 fractions, 20 Gy in 5 fractions, and 30 Gy in 10 fractions.
15872419|NCT03862911|Radiation|Stereotactic ablative radiotherapy|"Lung:
~Tumors 5 cm or less surrounded by lung parenchyma 48 Gy/4#, or 54 Gy/3#, daily or every second day Within 2 cm of mediastinum or brachial plexus 60 Gy/8#, daily
~Bone: Any bone 35 Gy/5#, or 24 Gy/2#, daily Brain: Stereotactic lesions (no whole brain RT) <2cm 20-24 Gy/1#, once 2-3 cm 18 Gy/1#, once Metastases only: 35Gy/5# to PTV, daily Whole brain + Mets: 35Gy to metastases, daily 20 Gy whole brain, daily Liver: 54 Gy/3#, every second day Adrenal: 40 Gy/5#, daily Lymph Node: 40 Gy/5#, daily"
15872420|NCT03862898|Other|Lumbar stabilization exercises|Patients performed exercises to stabilize and strengthen paravertebral muscles. Three sets of ten repetitions with a minute break between each.
15872421|NCT03862885|Drug|Avapritinib|Avapritinib will be administered orally (PO) at a dose of 300 mg once daily (QD) in continuous 28-day cycles.
15872558|NCT03861806|Behavioral|PAS sham|Participants will receive paired associative stimulation (transcranial magnetic stimulation and peripheral nerve stimulation) with an inter-stimulus interval length known to not modulate corticospinal excitability.
15872422|NCT03862872|Dietary Supplement|Anti-Aging Formula|Anti-Aging Formula contains 1050 mg of EPA and 350 mg of DHA from anchovies, sardines, and/or mackerel whole body oil, 120 mg of GLA from Borage (Borago officianalis) seeds, 2.5 mg of zeaxanthin from Capsicum annuum L. fruit, 5 mg of lutein from Tagetes erecta flower, and 25 μg (1000 IU) of vitamin D3 (cholecalciferol) from lanolin per 4 capsule daily dose. This dosage form is the same as is commercially marketed in Canada under license Natural Product Number (NPN) 80077254.
15872423|NCT03862872|Dietary Supplement|Control Fish Oil|The control fish oil is a soft gelatin capsule containing 1,106 mg of triglyceride fish oil from anchovies, sardines, and/or mackerel whole body oil. A four capsule per day dose provides 816 mg EPA and 572 mg DHA, which is only slightly less EPA+DHA than is provided within a four capsule per day dose of Anti-Aging Formula. This minor difference would not be expected to alter clinical outcomes.
15872424|NCT03862872|Other|Inert Placebo|The inert placebo is a soft gelatin capsule containing 1040 mg of corn oil.
15872425|NCT03862859|Drug|Warfarin|Dose adjusted Warfarin targeting an international normalized ratio of 2-3.
15872426|NCT03862846|Drug|REN001|Once daily
15872427|NCT03862833|Drug|IL2|"Three IL2 levels will be tested:
~Level 1: 2 millions UI/Infusion Level 2: 4 millions UI/Infusion Level 3: 6 millions UI/Infusion 4 weeks, 5 days per week from day + 15 post graft to day + 40"
15872428|NCT03862833|Drug|Zoledronic Acid|4 mg at day +15 post graft
15872429|NCT03862820|Diagnostic Test|dynamic ultrasound|move abdomen with ultrasound probe to predict intraabdominal adhesions
15872430|NCT03862807|Drug|Patisiran|Patisiran will be administered by intravenous (IV) infusion.
15872431|NCT03862794|Behavioral|new social norm feedback letter with bar chart|letter with the percentile prescribing the practice is on and a bar chart, comparing prescribing to the national average
15872432|NCT03862794|Behavioral|standard social norm feedback letter|social norm feedback letter used as standard practice, without specific information about the prescribing percentile
15872433|NCT03862781|Procedure|Right Hemicolectomy|Minimally invasive approach (robotic or laparoscopic) with the creation of an anastomosis.
15872434|NCT03862768|Procedure|surgery|Surgery requires at least removal of all drug-resistant lesions.
15872435|NCT03862768|Drug|Imatinib 400 MG|Imatinib 400 MG/d should be taken once the patients resume oral diet
15872436|NCT03862768|Drug|Imatinib escalation|Imatinib 600 MG/d
15872437|NCT03862768|Drug|Sunitinib|Sunitinib 37.5 MG/d
15872438|NCT03862755|Drug|Chemoprophylaxis with Low Molecular Weight Heparin (LMWH)|Early chemoprophylaxis means low-molecular weight heparin (LMWH) 3075 IU (WHO Units) injection subcutaneously QD no later than 24 hours after surgery. Early ambulation means activity out of bed no later than 24 hours after surgery. According to different risk level, patients received different thromboprophylaxis strategies. Early ambulation alone was for patients at low risk (Caprini 0-4), early chemoprophylaxis plus early ambulation was for patients at moderate (Caprini 5-8) or high risk (Caprini ≥9).
15872439|NCT03862729|Procedure|Minimally invasive surgery|Intracranial hematoma will be removed by intraoperative stereotactic computer tomography-guided endoscopic surgery, or surgical aspiration followed by alteplase clot irrigation (1·0 mg every 8 h for up to nine doses). CTA will be performed before operation in all the patients for intraoperative navigation, and the minimally invasive surgery will be performed within 24 hours after intracerebral hemorrhage onset.
15872440|NCT03862729|Procedure|conventional treatment|Conventional treatment includes medical treatment and conventional craniotomy.
15872441|NCT03862716|Drug|IDegLira|Dose is titrated to achieve fasting normoglycemia
15872442|NCT03862716|Drug|insulin degludec|In those who need additional insulin or who cannot tolerate IDegLira, insulin degludec will be used. Dose is titrated to achieve fasting normoglycemia.
15872443|NCT03862716|Drug|Metformin|Dose is titrated to 2000 mg per day or maximal tolerated dose
15872444|NCT03862716|Behavioral|Lifestyle Therapy|Lifestyle intervention includes individualized dietary and exercise advice targeting at least 5% weight loss with frequent visits and coaching for goal reinforcement, behavior modification and problem-solving
15872445|NCT03862703|Device|mHealth intervention, PTSD Help app.|Experimental group will receive the app, PTSD Help.
15872446|NCT03862690|Drug|BIAsp 30|Participants will receive commercially available BIAsp 30 once daily (QD), twice daily (BID) or thrice daily (TID) for 24 weeks according to routine clinical practice. The physician will determine the starting dose and any potential later change to the dose. The decision to switch the patient to NovoMix® 30 is at the treating physician's discretion and independent from the decision to include the patient in the study.
15872447|NCT03862677|Other|No intervention|Observational study, no intervention
15872448|NCT03862664|Procedure|Collection of data|The investigators will retrieve retrospectively the medical record of donors who underwent hepatic lobectomy for liver transplantation
15872449|NCT03862651|Drug|Cangrelor|Cangrelor is an intravenous analog of adenosine triphospate with a potent, selective and specific affinity for P2Y12 receptors.
15872450|NCT03862638|Other|Yoga Therapy|Yoga therapy is therapeutic application of yoga, specifically designed to treat the condition using physical posture, breathing exercises, guided relaxation and meditation.
15872453|NCT03862612|Procedure|regional anaesthesia with Levobupivicaine 0.25% 30mls with two methods either erector spinae plane block or serratus anterior plane block|Erector Spinae Plane Block will be compared to the Serratus Anterior Plane Block in patients undergoing Video assissted thoracic surgery
15872454|NCT03862599|Device|Extra-corporeal shockwave therapy (ESWT)|low-intensity extra-corporeal shockwave therapy
15872455|NCT03862599|Other|Standard care|Cialis and vacuum pump
15872456|NCT03862586|Drug|N-acetyl cysteine|
15872457|NCT03862586|Drug|Placebos|
15872458|NCT03862573|Device|Virtual Reality|Participants wear a Virtual Reality headset that consists of a ASUS phone and a VOX+ Z3 3D Virtual Reality Headset. The phone runs the VR Roller Coaster app to produce the virtual environment.
15872459|NCT03862560|Other|Strength training program|Strength training program in female soccer players
15872559|NCT03861793|Biological|ALKS 4230|SC injection administered in the back of the arm or the abdomen
15872560|NCT03861793|Biological|Pembrolizumab|Administered as an intravenous (IV) infusion over 30 minutes
15872460|NCT03862547|Diagnostic Test|A peripheral blood sample from the cubital vein|"Evaluation of NGF and Cytokine levels A portion of each blood sample and medium conditioned by PBMC will be used for the enzyme immunoassay of NGF and pro and anti-inflammatory cytokine levels (TNF alfa and IL-10).
~Expression analysis of TrKA and p75NTR receptors and intracellular cytokines in PBMCs The remaining part of each blood sample and PBMC of the in vitro experiment will be used for the cytofluorimetric evaluation of the expression of TrKA, p75NTR and the pro and anti-inflammatory cytokines and reactive oxygen species."
15872461|NCT03862534|Procedure|CAF|After the cementum enamel junction (CEJ) was restorated, a split thickness flap was raised, coronally advanced and sutured to cover the recession
15872462|NCT03862534|Procedure|CAF + CTG|After the cementum enamel junction (CEJ) was restorated, a split thickness flap was raised. Then a connective tissue graft was harvested from the palate and sutured over the exposed root. Finally the flap was coronally advanced and sutured to cover the recession
15872463|NCT03862521|Other|Low carbohydrate diet|Low carbohydrate diet
15872464|NCT03862521|Other|Very low carbohydrate diet|Very low carbohydrate diet
15872465|NCT03862508|Other|Plyometric exercises|"Jump Drop Jump, dropping the subject from a height of 30cm and then make a vertical jump.
~Long jumps asking the athletes to take momentum and make a leap forward trying to reach the greatest possible distance.
~Jump Countermovement jump unilaterally, alternating the lower extremities. Jumps 180º with the athletes maintaining a semi-squat position. Jump Countermovement jump repeatedly starting from an upright position and the upper extremities in both hips.
~All the exercises will be done through 8 repetitions per session during the first two weeks, increasing two repetitions every two weeks (until reaching 12 repetitions at the end of the intervention).
~For the realization of each one of the exercises, the ballasted weight will be used (Powerinstep® model)."
15872466|NCT03862495|Diagnostic Test|C. trachomatis and N. gonorrhoeae|In vitro nucleic acid amplification test for the qualitative detection of Chlamydia trachomatis and/or Neisseria gonorrhea in patient specimens utilizing amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of C. trachomatis and N. gonorrhoeae.
15872467|NCT03862495|Drug|Azithromycin|Azithromycin 1g administered as a single oral dose
15872468|NCT03862495|Other|Partner notification and treatment|Pregnant women who test positive for Chlamydia will also be suggested to take Azithromycin home to treat their spouses
15872469|NCT03862482|Device|Brånemark® 2, Swede-Vent® 2, Screw-Vent® 1 (Configuration 1)|Brånemark® implant placed at sites 2 (left medial) and 5 (right distal), Swede-Vent® implant placed at sites 1 (left distal) and 4 (right medial), Screw-Vent® implant placed at site 3 (para symphysis)
15872470|NCT03862482|Device|Brånemark® 1, Swede-Vent® 2, Screw-Vent® 2 (Configuration 2)|Brånemark® implant placed at site 3 (para symphysis), Swede-Vent® implant placed at sites 2 (left medial) and 5 (right distal), Screw-Vent® implant placed at sites 1 (left distal) and 4 (right medial)
15872471|NCT03862482|Device|Brånemark® 2, Swede-Vent® 1, Screw-Vent® 2 (Configuration 3)|Brånemark® implant placed at sites 1 (left distal) and 4 (right medial), Swede-Vent® implant placed at site 3 (para symphysis), Screw-Vent® implant placed at sites 2 (left medial) and 5 (right distal)
15872472|NCT03862469|Procedure|Individualized laboratory test|Laboratory test administered between 6 and 2 days prior to the subsequent menstrual cycle.
15872473|NCT03862456|Other|Azithromycin|azithromycin (500 mg/24h/3 days)
15872474|NCT03862456|Other|Metronidazole|metronidazole (500 mg/8h/7 days)
15872475|NCT03862443|Behavioral|Fixed Incentive|The Fixed Incentive intervention is a fixed reward, in which participants are eligible for fixed weekly payments based on toothbrushing performance collected through smart powered toothbrush synced to a smartphone app.
15872476|NCT03862443|Behavioral|Drawing Incentive|The Drawing Incentive intervention is a drawing reward, in which participants are eligible for weekly payments based on toothbrushing performance collected through smart powered toothbrush synced to a smartphone app.
15872477|NCT03862430|Drug|NVX-108|0.1 mL/kg (2% w/vol emulsion)
15872478|NCT03862430|Drug|Placebo Saline Infusion|0.1 mL/kg Saline Infusion
15872479|NCT03862417|Other|Schroth exercises|An exercise program begun individually and then continued in groups.
15872480|NCT03862404|Drug|Bupivacaine-epinephrine|See previous description
15872481|NCT03862404|Drug|Normal saline|See previous descreption
15872482|NCT03862391|Drug|Analgesics|while patients are in the PACU after general anesthesia, if patients' VAS scores are higher than 3, we will give them 50 mg of deksketoprofen as analgesic.
15872483|NCT03862391|Drug|Antiemetics|while patients are in the PACU after general anesthesia, if patient' Nausea and vomiting scores are higher than 1, we will give them 4 mg of ondansetron
15872484|NCT03862365|Genetic|Nerve conduction Studies|Patients will be genotyped for comparison of patients With and without pain, With different clinical subgroups as mentioned.
15872485|NCT03862352|Device|Covered coronary stent|Insertion of covered coronary stent as part of standard care
15872486|NCT03862326|Behavioral|Exercise|From lying to sitting to active exercises with focus on the pelvic floor
15872487|NCT03862313|Device|active-rtACS treatment|For the active-rtACS treatment arm, a CE-certificated proprietary class IIa medical device will be used to apply transorbital symmetrical rectangular current pulses in bursts (NextWave® 1.1 system; EBS Technologies GmbH, Germany). The stimulation protocol will be patient-individualized, with a stimulation current strength of 125% of the phosphene threshold recorded during 5Hz stimulation and stimulation frequencies between the individual's EEG alpha frequency and their flicker fusion frequency.
15872488|NCT03862313|Device|sham-rtACS treatment|For the sham-rtACS treatment arm, exactly the same medical device, setup, time schedule, etc. will be used as for the patients of the active-rtACS arm. However, sham-treated patients will receive no actual current stimulation during the therapy sessions.
15872489|NCT03862287|Drug|Lidocaine|See arm description.
15872490|NCT03862287|Drug|Bupivacaine Hcl 0.5% Inj_#2|See arm description.
15872491|NCT03862274|Other|CLN2 Treatment|Patients that have a TPP1 enzyme deficiency and/or confirmed molecular diagnosis of pathogenic variants in the TPP1 gene are eligible to participate if they are receiving cerliponase alfa.
15887934|NCT03743649|Other|Quality-of-Life Assessment|Ancillary studies
15872492|NCT03862261|Other|Integrated pediatric TB services|"pediatric TB services will be integrated into key child healthcare services: maternal neonatal and child health (MNCH) services, under-5 clinic, pediatric outpatient services, nutrition services, pediatric antiretroviral therapy (ART) services and primary health care:
~Integration of the screening into all the child health care services with introduction of a specific case detection tool and updated presumptive TB register.
~Improvement of diagnosis capacities and their integration in all levels of care and all services."
15872493|NCT03862248|Drug|6EH³RZ|New high-dose isoniazid retreatment regimen (6EH³RZ) - H 15mg/kg
15872494|NCT03862248|Drug|6EHR³Z|New high-dose rifampicin retreatment regimen (6EHR³Z) - R 30mg/kg
15872495|NCT03862248|Drug|6EHRZLfx|WHO levofloxacin-strengthened regimen (6EHRZLfx)
15872496|NCT03862235|Diagnostic Test|Cardiovascular Magnetic Resonance|The patients underwent to CMR examination on a Philips Achieve 1.5 device. Images were acquired coupled to the electrocardiogram and during respiratory pause, in four chambers, short axis and long axis of the left ventricle, in the same exact location in different sequences. A gradient - echo sequence (steady-state free precession) was used to evaluate cardiac function (functional evaluation). We will also evaluate T1 weighted images (T1 -relaxation times) and T2, performed sequentially, through spin-echo pulse (black-blood), triple inversion recovery sequence, for the morphological evaluation
15872497|NCT03862235|Diagnostic Test|Transthoracic echocardiography|The images were collected by the Vivid E9. The patients were submitted to one-dimensional (M-mode), two-dimensional (B-mode), and three-dimensional (three-dimensional) echocardiographic studies. The images obtained were associated with pulsed, continuous and color Doppler.
15872498|NCT03862222|Other|Retinal Imaging|Retinal imaging will be conducted on the Heidelberg SPECTRALIS (FDA 510k cleared) device, routinely used in clinical care in ophthalmology. Optical Coherence Tomography (OCT) and Angiography (OCT-A) sequences will be conducted, as well as a sequence examining macular pigment (MPOD).
15872499|NCT03862222|Other|Pupillometry|Participants will complete a task studying pupillary response to light
15872500|NCT03862222|Other|Contrast Sensitivity|Participants will complete a task evaluating contrast sensitivity
15872501|NCT03862222|Diagnostic Test|Neuropsychological Evaluation|Neuropsychological evaluation will be completed, including testing in domains of memory, executive function, visuospatial ability, language, processing speed. Results will be used for research purposes only.
15872502|NCT03862222|Genetic|APOE genotyping|APOE genotyping will be completed during screening to assign participants to the correct group. Results will not be shared with participants as part of the study.
15872503|NCT03862222|Other|blood draw|Blood will be drawn and banked for proteomic, biomarker, and GWAS analysis
15872504|NCT03862222|Other|Gait Assessment|Gait assessment will be conducted by trained researcher
15872505|NCT03862222|Other|Actigraphy|Actigraphy monitors will be worn by all participants for 2 weeks after each visit to examine physical activity, movement, and sleep patterns.
15872506|NCT03862209|Other|Community mental health team|CMHT will provide home-based treatment inclusive of crisis resolution services and procedures for early recognition of subclinical psychosis and bipolar disorder, and intensive case management. Integrated care (i.e. health and social care interventions) will be provided to all clients. Furthermore, health and social care evidence-based interventions for severe mental illness (SMI) will be employed during home treatment, such as family-based interventions, motivational interviewing, and cognitive behavioural therapies, combined with medication management and identifying employment (paid and non paid options) and support in finding and maintaining this employment, recovery groups and housing opportunities.
15872507|NCT03862196|Behavioral|Tailored text messages to improve retention in HIV care|Trained counselors will deliver the text messages. After a block randomization, the trained counselor (a nurse) will send the first welcoming message to participants in the intervention arm. The nurse will send 2 tailored text messages per week. In addition 2 to 4 days before an appointment, the nurse will send a message reminder. In addition, the nurse will have bilateral communication with participants using text messages according to their needs. The participants of the intervention arm will interact with the nurse during 3 months with a semi-structured strategy, that is, with template text messages (predesigned) and open messages (for which the nurse will be trained). Three and six months after started the intervention the variables of interest will be assessed.
15872508|NCT03862183|Other|continuing medical education program|educating all the involved doctor the same medical knowledge on hypertension control
15872509|NCT03862170|Drug|Ciprofloxacin|Ciprofloxacin 400 mg IV 120mn before HDR brachytherapy
15872510|NCT03862170|Drug|Cefazolin|
15872511|NCT03862157|Drug|Azacitidine|Given IV or SC
15872512|NCT03862157|Drug|Pevonedistat|Given IV
15872513|NCT03862157|Drug|Venetoclax|Given PO
15872514|NCT03862144|Drug|Netupitant/Palonosetron|
15872515|NCT03862131|Device|MyoStrain®|MyoStrain® SENC software receives image data from MRI storage archives and performs viewing, image manipulation, communication, printing, and quantification of images.
15872516|NCT03862118|Other|PRP|platelet rich plasma will be delivered by intradermal method using mestherapy needle.
15872517|NCT03862105|Other|Mobile Health app tool - Twistle|The investigators propose to use radical cystectomy as a model to examine the utilization of an electronic, internet-based mobile health intervention that can prospectively collect Patient Reported Outcome data while providing timely feedback to patients and clinicians. This mobile health intervention will utilize a well-established platform (Twistle) that can be accessed through multiple technologies, including laptops, smartphones, and other computer-based systems.
15872518|NCT03862092|Diagnostic Test|Salivary VZV-DNA PCR|VZV-DNA PCR of saliva samples
15872519|NCT03862079|Other|Best Practice|Given standard of care
15872520|NCT03862079|Procedure|Fecal Microbiota Transplantation|Undergo FMT
15872521|NCT03862079|Drug|Nystatin|Given PO
15872522|NCT03862079|Drug|Piperacillin-Tazobactam|Given PO
15872523|NCT03862066|Other|Blood collection|5 milliliters (mL) of blood will be collected at the time of surgery
15872524|NCT03862066|Other|Tissue collection|Left over tissue will be collected at the time of surgery
15872525|NCT03862053|Drug|Manuka honey|manuka eyedrops applied to the ocular surface
15872526|NCT03862040|Drug|Cefiderocol|Administered intravenously, at a dosage determined based on renal function.
15872527|NCT03862040|Drug|Standard of Care Antibiotic|Standard of care antibiotic treatment for pneumonia
15872528|NCT03862027|Device|Esophageal Balloon catheter|"Pressures [Esophageal Pressure (Pes), Airway Pressure (Paw), and Transpulmonary Pressure (Ptp)] are measured directly through the ventilator. The waveforms of Paw, Pes, and Ptp will be visualized on the ventilator. Ptp is obtained from Paw - Pes. All patients will have baseline measurements recorded of ICP, CPP, and MAP.
~PEEP will be increased on the ventilator to achieve a Ptp between 0 and +2 cm H2O (Optimal PEEP).
~Measurements of Intracranial pressure (ICP), cerebral perfusion pressure (CPP), and mean arterial pressure (MAP) will be repeated 5 minutes after the change in PEEP."
15872529|NCT03862014|Device|SDF only|Molar with MIH will be treated with SDF
15872530|NCT03862014|Device|SDF+ARR|Molar with MIH will be treated with SDF+ARR
15872531|NCT03862001|Behavioral|LungCARE|"The LungCARE intervention involves patient and PCP components. The patient component consists of watching a short, educational video, answering questions about lung cancer screening preferences, and receiving a patient report and handout.
~The PCP component consists of receiving a similar report (physician report) prior to the patient visit. This report is based on the patient's risk factors and lung cancer screening preferences. It contains additional information about documenting discussions related to risk, screening, and referrals in the electronic medical record system."
15872532|NCT03861988|Drug|Ketamine|0.5 mg/kg over 40 minutes, intravenous.
15872533|NCT03861988|Drug|Normal saline (placebo)|Normal saline infusion over 40 minutes, equivalent volume to ketamine infusion.
15872534|NCT03861975|Other|Breast Cancer-Related Lymphedema Measurements|All patients will receive bilateral arm measurements using the LymphaTech Scanner and the Perometer.
15872535|NCT03861962|Other|"DNA sequencing called new generation (or NGS)"|"Redo HLA-typings with a method exploring all the genes (add DQA1, DRB3 / 4/5, DPB1 and DPA1), i.e. DNA sequencing called new generation, when this has not been done after the graft as part of the standard care"
15872536|NCT03861949|Other|5 cmH2O CPAP|
15872537|NCT03861949|Other|head-up position|
15872538|NCT03861936|Biological|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A;BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1.
15872539|NCT03861936|Drug|Normal saline|Normal saline (placebo) administered intramuscularly to the bilateral masseter muscles on Day 1.
15872540|NCT03861923|Other|Dry needling|Trigger point dry needling to trigger points in the shoulder or parascapular muscles using monofilament needle (i.e., acupuncture needle). Clean needle approach using sterile needles.
15872541|NCT03861923|Other|Sham Dry Needling|Sham needle approach using a finishing nail in a tube sheath. The finishing nail will be placed over the trigger point so that the patient perceives a sharp sensation. The tube (not the nail) will be moved up and down to mimic the action of needling.
15872542|NCT03861923|Other|Therapeutic Exercise|Exercise including flexibility, range of motion, strengthening will be provided by the treating physical therapist based on the impairments identified.
15872543|NCT03861910|Dietary Supplement|hypoallergenic formulas|hypoallergenic formulas used for cow milk allergy treatment
15872544|NCT03861897|Other|KRP-NI + KM|Non instrumental pleural chest physiotherapy (KRP-NI), 2 sessions a day on weekdays and 1 session a day on weekends and mobilization physiotherapy (KM), 1 session per day except weekend during the hospitalization. The combination of the two physiotherapy is KRP-NI + KM. Afterward, 3 sessions per week, renewable until M3 of non instrumental pleural respiratory physiotherapy. If necessary the doctor can prescribe sessions of mobilization physiotherapy
15872545|NCT03861897|Other|KM|Mobilization physiotherapy (1 session per day except weekend) during the hospitalization. Afterward, if necessary the doctor can prescribe sessions of mobilization physiotherapy(KM).
15872546|NCT03861884|Diagnostic Test|Cognitive assessments|Cognitive assessment and MRI at 3T and/or 7T
15872547|NCT03861871|Drug|Fenfluramine Hydrochloride|Oral Solution 2.5mg/mL
15872548|NCT03861858|Behavioral|DBT-A|DBT-A is a multimodal therapy which consists of weekly individual therapy, weekly multifamily skills groups, as needed phone coaching, and weekly consultation team for the therapists.
15872549|NCT03861845|Device|Standard off-the-shelf pillbox|Then the participant will receive a store bought one-dose per day pillbox.
15872550|NCT03861845|Device|Custom off-the-shelf pillbox|Then the participant will be administered an off-the-shelf pillbox that was purchased specifically for the participant's preferences, routine, medication regimen, and skills/abilities.
15872551|NCT03861845|Device|Custom designed and manufactured pillbox|Then the participant will describe any design preferences for the pillbox. The researcher will design and manufacture the pillbox using a 3D printer, publically available 3D printing object repository, and computer aided design software.
15872552|NCT03861845|Behavioral|Education & Training|The participant will receive education and training on how to use the pillbox and how to incorporate the pillbox and taking medications into their daily routine.
15872553|NCT03861845|Behavioral|Reflection on medication routines|The participant will reflect on his or her daily routine, medication regimen, and use of existing pillboxes. The participant will also engage in a hands-on standardized pillbox task.
15872554|NCT03861832|Dietary Supplement|KB220Z|Acts to enhance dopamine
15872555|NCT03861832|Dietary Supplement|Placebo|A placebo that looks the same, but does not contain amino acid precursors or any active ingredients in the nutraceutical
15872556|NCT03861819|Behavioral|Vigorous-intensity interval training (VIIT)|Subjects will be fitted with a heart rate monitor around the chest and a baseline 4ml blood sample will be drawn. Vigorous intensity interval training will correspond to heart rate (HR) range of 80-90% of heart rate at age-predicted heart rate maximum (220-age). After approximately 5 minutes of warmup subjects will perform 10 intervals of VIIT: 30 seconds of vigorous intensity exercise followed by 60 seconds of rest. Rated Perceived Exertion (RPE) will be rated by 15-point Borg scale; should correspond to HR/10 at end of each interval. The subject will self-adjust the intensity of the exercise bouts and will be encouraged by the researcher to achieve the desired intensity. The exercise session will finish with a short cool-down period and will last no more than 25 minutes in total. A 4ml blood sample will be drawn immediately following the exercise session and 2-hours after exercise cessation.
15872557|NCT03861806|Behavioral|PAS true|Participants will receive paired associative stimulation (transcranial magnetic stimulation and peripheral nerve stimulation) with an inter-stimulus interval length known to modulate corticospinal excitability.
15872564|NCT03861767|Drug|Metformin ER|tablet
15872565|NCT03861767|Drug|Placebo|Matched placebo in doses of 1, 2 and 3 tablets to coincide with the 500, 1000, and 1500 mg arms.
15872566|NCT03861754|Behavioral|Lifestyle modification|
15872567|NCT03861741|Genetic|WES|A peripheral venous blood sample will be processed internally, and externally subjected to WES. Only genetic material from relatives of probands in which a mutation has been identified will be sequenced.
15872568|NCT03861741|Diagnostic Test|MRI|A MRI of the thoracic aorta will be performed in all relatives able to attend the Glenfield Hospital and who have no contra-indications to this imaging modality; pulse-wave velocity will be recorded.
15872569|NCT03861741|Diagnostic Test|TTE|TTE screening will be performed by a trained physiologist. Aortic diameter will be measured from the parasternal long-axis view at the sinuses of Valsalva and at the widest level of the ascending aorta. All measurements will be made in end-diastole.
15872570|NCT03861741|Other|Questionnaire|Acceptability questionnaires will be submitted to assess a baseline score of depression/anxiety that will be compared with a follow up value at three months
15872571|NCT03861728|Device|0.01% Hypochlorous acid|Randomized to treatment 0.01% Hypochlorous acid four times a day to the affected eye for 2 weeks. (Avenova is a FDA approved device)
15872572|NCT03861728|Other|Placebo|Placebo to be used four times a day to the affected eye for 2 weeks
15872573|NCT03861715|Diagnostic Test|live birth rate|The blastulation rate and live birth rate according to the protocol of COS
15872576|NCT03861689|Diagnostic Test|MRI pelvis|MRI pelvis monitoring every 6 months; FiLAC to treat fistula tract within 24 months if the anatomy of the fistula is favourable
15872577|NCT03861676|Radiation|Focal brachytherapy with PSMA PET imaging|Focal brachytherapy with PSMA PET imaging. Focal (partial prostate gland) brachytherapy following 18F-DCFPyl PET/CT radiotracer imaging. Patients will also undergo pre-treatment transperineal mapping biopsy.
15872578|NCT03861676|Drug|(18F)DCFPyL|18F-DCFPyl PET/CT scan
15872579|NCT03861663|Device|Ultrasound|Eligible subjects will be positioned for their ultrasound exam, which will take a similar amount of time and be performed in a similar manner as standard of care ultrasound exams at the site. The type and duration of ultrasound exam will be based on the subject's clinical condition.
15872580|NCT03861650|Other|Bone Marrow Aspirate Concentrate|A rich MSCs prepration made by centrifugation and concentration of aspirated bone marrow
15872581|NCT03861650|Other|Saline|Physiological saline is added in control group to act as placebo
15872582|NCT03861637|Other|ESA for correction of PTA to 12-13g/dl|To assess the impact of full correction of chronic PTA(to near normal values) on cardiovascular system and quality of life in renal transplant recipients with stable graft function using erythropoietin stimulating agents in comparison to partially treated PTA with HB level between 12-13g/dl.
15872583|NCT03861624|Procedure|Intramedullary nailing with standard SIGN nail|Patients meeting eligibility requirements are randomized to either study arm. Patients receive definitive fixation of AO/OTA-42 open tibia diaphyseal fractures using the standard SIGN nail (SIGN Fracture Care International, Richland, WA). The number of interlocking screws is at the discretion of the treating surgeon, who also has the option to use an external fixator for damage control, and later conversion to IMN when clinically appropriate. The experimental group procedure is less common in the study setting, and thus, viewed as the experimental group.
15872584|NCT03861624|Procedure|External Fixation with uniplanar Dispofix external fixator|Patients meeting eligibility requirements are randomized to either study arm. Patients receive definitive fixation of AO/OTA-42 open tibia diaphyseal fractures using the uniplanar Dispofix external fixator with two Shanz screws placed proximally and two Schanz screws placed distally to fracture site with a single stainless steel bar.The active comparator group procedure is more common in the study setting, and thus, viewed as the comparator group.
15872585|NCT03861611|Drug|Ketorolac|Participants may be randomized to receive Ketorolac oral medication 10 mg, every 8 hours for 5 days as needed
15872586|NCT03861611|Drug|Ibuprofen|Participants may be randomized to receive Ibuprofen oral medication 600 mg, every 8 hours for 5 days as needed
15872587|NCT03861611|Drug|Diclofenac|Participants may be randomized to receive Diflofenac oral medication 50 mg, every 8 hours for 5 days as needed
15872588|NCT03861611|Behavioral|Educational Intervention|Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp)
15872589|NCT03861598|Drug|Carvedilol|Carvedilol orally starting at 6.25 mg and increasing to 12.5 mg if tolerated after 1-2 weeks for a total of 4 cycles of treatment.
15872590|NCT03861585|Other|Semantic group|"The semantic task has to categorise semantically (i.e., type of contexts or type of objects) one image at each trial."
15872591|NCT03861585|Other|Emotional group|"The emotional task has to evaluate the emotional content (i.e., neutral, positive or negative) of one image at each trial."
15872592|NCT03861572|Other|Isokinetic eccentric training|Training sessions will be performed in the same isokinetic dynamometer used in previous evaluations, twice a week, with a minimum interval of 72 hours between sessions.
15872593|NCT03861572|Other|Traditional eccentric training|Training sessions will be performed at university gym, twice a week, with a minimum interval of 72 hours between sessions.
15872594|NCT03861559|Drug|mometasone furoate nasal spray|intranasal administration
15872595|NCT03861559|Drug|placebo nasal spray|intranasal administration
15872596|NCT03861546|Behavioral|Healthy lifestyle Shared Medical Appointment (SMA) program|Social network-based, culturally-tailored healthy lifestyle SMA program for high risk SAs will be piloted to collect pre-post data on diet and exercise habits, and to determine feasibility and acceptability. Patients will participate in physician-led group visits every other week focused on improving dietary and exercise practices to reduce weight. Biometric measurements (weight, height, blood pressure) will be collected, point of care glucose and lipid testing will be done.
15872597|NCT03861533|Other|survey|Cross-Reference
15872598|NCT03861520|Device|Midtrimester anomaly scan|A detailed anomaly scan to detect soft markers at 16 to 24 weeks pregnancy
15872599|NCT03861520|Genetic|Fetal Karyotyping|Fetal karyotyping after birth to confirm chromosomal anomaly diagnosed clinically
15887935|NCT03743649|Other|Questionnaire Administration|Ancillary studies
15872601|NCT03861494|Behavioral|Enhanced Stroke Education|In addition to the general stroke education materials and verbal education, the enhanced stroke education group will receive a personalized verbal and written information addressing the patient's specific risk factors including their current status and goals, laboratory values and goals, and current blood pressure and goal. Specific stroke type and etiology is discussed, medication including indication, dose, frequency, physical activity goals, smoking cessation resources, appropriate diet, stroke signs and symptoms and best practice if one sees a stroke (BE-FAST), phone number to call for non-urgent questions, and education over the importance of keeping follow up appointments including Stroke Clinic. Verbal feedback of key points is encouraged.
15872602|NCT03861494|Behavioral|Usual Stroke Education|The usual stroke education group will receive general stroke education including written and verbal information about signs and symptoms of stroke, best practice to engage medical treatment if stroke occurs, general information about heart healthy diet and need for daily physical activity as well as need for compliance with medication recommendations. The education is incorporated with routine patient care and as allowed during quiet times. On the day of discharge, the patient will receive written materials reviewing stroke symptoms, risk factors, heart healthy diet and follow up appointments. The patient will receive written and verbal information about medications including indication, dose, frequency, physical activity goal, smoking cessation resources, appropriate diet, stroke signs and symptoms and best practice if one sees a stroke (BE-FAST), phone number to call for non-urgent questions, the importance of keeping follow up appointments including Stroke Clinic.
15872603|NCT03861481|Drug|Rozanolixizumab|Subjects will receive rozanolixizumab in a specified sequence during the treatment period.
15872604|NCT03861481|Other|Placebo|Subjects will receive placebo in a specified sequence during the treatment period.
15872605|NCT03861468|Other|Care pathway|Screening for OSA using a combination of bicarbonate assay and STOP-BANG questionnaire and further management by a pneumologist as necessary
15872606|NCT03861455|Drug|Dupilumab|patient receive dupilumab 300 mg every 2 weeks after a 600 mg-loading dose of dupilumab on day 0
15872607|NCT03861455|Drug|placebo|patient receive placebo
15872608|NCT03861429|Behavioral|Me & My Wishes|Me & My Wishes videos communicate residents' preferences via personalized video recorded conversations. Me & My Wishes are videos of nursing home residents talking about their preferences for care, and include four sections: About Me, Preferences for Today, Preferences for Medical Intervention and End of Life, and Afterthoughts.
15872609|NCT03861416|Drug|L-arginine 1.4% 500 ml|Infusion of L-arginine 1.4% solution by 500 ml (2 vials 250 ml each) IV daily for 10 days
15872610|NCT03861416|Drug|L-arginine 1.4% 250 ml + placebo 250 ml|Infusion of L-arginine 1.4% solution 250 ml IV daily for 10 days and placebo infusion by 250 ml IV daily for 10 days.
15872611|NCT03861416|Drug|Placebo solution|Infusion of Ringer's solution by 500 ml (2 vials 250 ml each) IV daily for 10 days
15872612|NCT03861403|Drug|TRX518|Administered by IV infusion
15872613|NCT03861403|Drug|Cyclophosphamide|Administered by IV infusion
15872614|NCT03861403|Drug|Avelumab|Administered by IV infusion
15872615|NCT03861390|Drug|60 mg Prednisone|Immediately following exit from the wood smoke chamber, subjects will receive 60 mg of prednisone per randomization schema
15872616|NCT03861390|Drug|Placebo|Immediately following exit from the wood smoke chamber, subjects will receive a matching placebo to the 60 mg of prednisone per randomization schema
15872617|NCT03861377|Drug|Remifentanil R2|0,7 microg/kg
15872618|NCT03861377|Drug|Remifentanil R4|1,1 microg/kg
15872619|NCT03861377|Drug|Remifentanil R8|1,7 microg/kg
15872620|NCT03861364|Drug|Propofol|2,4 mg/kg
15872621|NCT03861364|Drug|Propofol|1,4 mg/kg
15872622|NCT03861351|Device|Mini WELL Toric Ready intraocular lens|The aim of cataract surgery is to remove the cloudy lens and replace it with the artificial intraocular lens called Mini WELL Toric Ready to correct presbyopia and to correct corneal astigmatism.
15872623|NCT03861338|Drug|Sublocade|The monthly Sublocade buprenorphine extended-release (BXR) injection will be administered in two doses (100 mg and 300 mg). Following a 4 day induction onto oral buprenorphine, the first 300 mg injection of Sublocade will be administered. A second 300 mg Sublocade injection will be administered 1 month later and the third and final monthly injection of 100 mg of Sublocade will be administered 2 months post the successful buprenorphine induction.
15872624|NCT03861312|Behavioral|Neck Laterality|"Patients who belonged to the neck group performed the recognition of laterality with certain parameters. The execution of the recognition began with a test to familiarize themselves with the program at the Basic level and then followed the laterality test. It was done with 20 images and 4 seconds for each image in the Vanilla program"
15872625|NCT03861312|Behavioral|Foot Laterality|"Patients who belonged to the foot group performed the recognition of laterality with certain parameters. The execution of the recognition began with a test to familiarize themselves with the program at the Basic level and then followed the laterality test. It was done with 20 images and 4 seconds for each image in the Vanilla program"
15872626|NCT03861299|Procedure|Awake craniotomy|Awake craniotomy
15872627|NCT03861299|Procedure|Craniotomy under general anesthesia|Craniotomy under general anesthesia
15872628|NCT03861273|Biological|PF-06838435/ fidanacogene elaparvovec|Gene Therapy
15872629|NCT03861260|Procedure|Rigid cystoscopy with urethral dilatation|Patients will have a general anaesthetic and a rigid cytoscopic examination of the bladder dilated with sterile water. The urethra will be dilated from FR20 in incremental diameter increases of 2 to French 32 if possible.
15872630|NCT03861260|Procedure|Flexible cystoscopy and installation of Glycosaminoglycan layer replacement (laluril)|Patients will undergo flexible cystoscopy and intravesical installations of Hyaluronic acid (HA) + Chondroitin Sulphate (CS) (GAGs) weekly for 4 weeks and then at 8 weeks and 12 weeks.
15872631|NCT03861247|Drug|Phosphate-binder intervention|Use phosphate-binders according to KDIGO Guidelines, Chinese Guidance for Diagnosis and Treatment of Mineral and Bone Disorder in Chronic Kidney Disease and drug specification .
15872632|NCT03861247|Dietary Supplement|Phosphorus-restricted dietary intervention|Use low phosphorus diet and prolong the time of hemodialysis according to the phosphorus balance evaluation if necessary
15872633|NCT03861234|Drug|BI 836880|Solution for Intravitreal (IVT) injection
15872635|NCT03861208|Other|diet|foods with high satiation (high protein and high fiber foods) are offered to modify children's hunger and fullness ratings postprandial
15872636|NCT03861208|Other|usual diet|foods representing the usually provided foods at childcare are offered
15872637|NCT03861195|Procedure|laparoscopic surgery|patients affected by uterine diseases that undergo treatment
15872638|NCT03861182|Biological|Biological functionalization of the prosthetic materials by PRF|The biological functionalization of the prosthetic materials by host PRF would improve the biological colonization of materials and thus reduce the risk of prosthetic release.
15872639|NCT03861169|Device|Transluminal viscoelastic delivery and trabeculotomy|Ab-interno transluminal viscoelastic delivery and trabeculotomy using OMNI Surgical System
15872640|NCT03861156|Drug|D-0316|Firstly, D-0316 was orally given 75mg for a cycle(21 days), if tolerated, the dose will be increased to 100mg. Otherwise, the dose will be maintained at 75mg.
15872641|NCT03861143|Drug|BT-11 (500 mg)|Subjects will be randomized to receive BT-11 low-dose (500 mg) once-daily for 12 weeks. All tablets administered (placebo and BT-11) will have the same appearance and size. Each subject will receive blister packs of the study drug (high-dose BT-11, low-dose BT-11, or placebo).
15872642|NCT03861143|Drug|BT-11 (1000 mg)|Subjects will be randomized to receive BT-11 low-dose (1000 mg) once-daily for 12 weeks. All tablets administered (placebo and BT-11) will have the same appearance and size. Each subject will receive blister packs of the study drug (high-dose BT-11, low-dose BT-11, or placebo).
15872643|NCT03861143|Drug|Placebo|Subjects will be randomized to receive Placebo once-daily for 12 weeks. All tablets administered (placebo and BT-11) will have the same appearance and size. Each subject will receive blister packs of the study drug (high-dose BT-11, low-dose BT-11, or placebo).
15872646|NCT03861104|Other|medical educational video|information based on visual and auditory communication
15872647|NCT03861091|Drug|risedronate|Risedronate 150 mg Oral Given once 7 - 21 days prior to initiation of SBRT
15872648|NCT03861091|Drug|Matching placebo|Dose not applicable, given once 7-21 days prior to initiation of SBRT
15872649|NCT03861078|Other|Own Brand Cigarette|Effects of own brand cigarette use.
15872650|NCT03861078|Other|ECIG 15 mg nicotine, sweetened|Effects of using a 30 Watt ECIG filled with 15 mg nicotine, sweetened liquid
15872651|NCT03861078|Other|ECIG 15 mg nicotine, unsweet|Effects of using a 30 Watt ECIG filled with 15 mg nicotine, unsweet liquid
15872652|NCT03861078|Other|ECIG 0 mg nicotine, sweetened|Effects of using a 30 Watt ECIG filled with 0 mg nicotine, sweetened liquid
15872653|NCT03861078|Other|ECIG 0 mg nicotine, unsweet|Effects of using a 30 Watt ECIG filled with 0 mg nicotine, unsweet liquid
15872654|NCT03861065|Procedure|Tertiary Wound Closure|The wound will be closed with what is considered tertiary wound closure. This means, rather than leaving the wound open, the wound will be partially closed after surgery, and then completely closed 4-7 days after surgery.
15872655|NCT03861065|Procedure|Historical Wound Closure|Participants wounds are left partially open to heal.
15872656|NCT03861052|Drug|Tirzepatide|Administered SC
15872657|NCT03861052|Drug|Dulaglutide|Administered SC
15872658|NCT03861039|Drug|Tirzepatide|Administered SC
15872659|NCT03861026|Device|Bilateral NIRS (Masimo, O3TM Regional Oximetry)|Bilateral NIRS (Masimo, O3TM Regional Oximetry) will be used to measure rSO2 intraoperatively. The NIRS electrodes will be placed on fronto-temporal area and baseline values of rSO2 obtained according to manufacturer's guidelines in the operating room prior to induction of anesthesia. The NIRS screen will be concealed in the control group to ensure blinding.
15872660|NCT03861013|Behavioral|Multidimensional stress prevention program (GeDStress)|The multidimensional stress prevention program (GeDStress) is composed of 8 session of 2-hour weekly sessions and integrated cognitive and behavioral strategies, mindfulness-based activities, emotional regulation and social skills exercises. Brief homework activities were given between sessions. The groups were composed by a maximum of 8 students and were led by two trained clinical psychologists.
15872661|NCT03861000|Drug|[C-11]T-1650|radio-labeled drug
15872662|NCT03861000|Drug|BPN14770|selective compound
15872663|NCT03860987|Drug|goserelin|Goserelin will be administered SC at 10.8 mg every 12 weeks
15872664|NCT03860987|Drug|Enzalutamide|Enzalutamide will be given orally at 160mg once daily
15872665|NCT03860987|Drug|Abiraterone|Abiraterone will be taken orally at 1000 mg once daily
15872666|NCT03860987|Drug|18F-DCFPyL|18F-labeled agent that is a high affinity small molecule inhibitor of PSMA to detect prostate cancer via PET imaging
15872667|NCT03860987|Drug|Prednisone|Prednisone will be taken orally at 5mg twice a day for each dose, or 10 mg once a day. Doses should be taken about 12 or 24 hours apart
15872668|NCT03860987|Procedure|Radical Prostatectomy|Radical Prostatectomy
15872669|NCT03860974|Drug|Serratus Plane block (single injection)|A single-injection serratus plane block will be administered using ropivacaine 0.5% with epinephrine 1:200,000-400,000 (20 mL of local anesthetic for unilateral surgery; 16 mL of local anesthetic each side for bilateral surgery).
15872670|NCT03860974|Drug|Paravertebral block (single injection)|Single injection paravertebral blocks will be administered using ropivacaine 0.5% with epinephrine 1:200,000-400,000 (20 mL for unilateral surgery; 16 mL each side for bilateral surgery). For paravertebral blocks without axillary involvement, this will be at the T3 and T5 levels. For paravertebral blocks with axillary involvement, this will be at the T2 and T4 levels. For unilateral PVBs, 10 mL of local anesthetic will be injected per level. For bilateral paravertebral blocks, 8 mL of local anesthetic will be injected per level.
15872671|NCT03860961|Other|Questionnaire Administration|Ancillary studies
15872672|NCT03860961|Other|Survivorship Care Plan (SCP)|Given survivorship care plan
15872673|NCT03860961|Other|Treatment Plan|Given treatment plan
15888384|NCT03740165|Drug|Carboplatin|IV infusion
15872674|NCT03860948|Drug|Savolitinib Test Preparation|Test preparation (T): dry granulation savolitinib tablets.
15872675|NCT03860948|Drug|Savolitinib Reference Preparation|Reference preparation (R): wet granulation savolitinib tablets.
15872676|NCT03860935|Drug|acoramidis|TTR stabilizer administered orally twice daily (BID)
15872677|NCT03860935|Drug|Placebo Oral Tablet|Non-active control administered orally twice daily (BID)
15872678|NCT03860922|Device|Magnetic Resonance Imaging|all patient will undergo Magnetic resonance imaging and magnetic imaging arthrography of the ankle joint.
15872679|NCT03860896|Drug|GB004|GB0004 high dose
15872680|NCT03860896|Drug|Placebo|Placebo
15872681|NCT03860896|Drug|GB004|GB004 low dose
15872682|NCT03860883|Procedure|Wide Local Excision = 1cm Margin|"A wide local excision involves removing an extra safety margin of skin surrounding the original melanoma site, to ensure that any remaining scattered melanoma tumour cells that may have been left behind after the first initial biopsy/surgery are removed."
15872683|NCT03860883|Procedure|Wide Local Excision = 2cm Margin|"A wide local excision involves removing an extra safety margin of skin surrounding the original melanoma site, to ensure that any remaining scattered melanoma tumour cells that may have been left behind after the first initial biopsy/surgery are removed."
15872684|NCT03860870|Drug|Clenbuterol Oral Product|Subjects ingest 4x20 microgram clenbuterol tablets
15872685|NCT03860870|Drug|Placebo|Subjects ingest placebo tablets
15872686|NCT03860857|Radiation|Amyloid PET scan|Amyloid Positron Emission Tomography scan using radio tracer florbetapir-F18
15872687|NCT03860857|Drug|Tau PET scan using MK-6240|Tau Positron Emission Tomography scan using radio tracer MK-6240
15872688|NCT03860857|Behavioral|Neurocognitive testing|A battery of clinical neuropsychological assessments and computerized cognitive tasks will be used to test participants' memory and cognitive abilities.
15872689|NCT03860857|Other|MRI|High-resolution structural, functional, and diffusion Magnetic Resonance Imaging scans will be collected during the study.
15872690|NCT03860844|Drug|Montelukast|Pharmaceutical form: tablet Route of administration: oral
15872691|NCT03860844|Drug|Isatuximab|Pharmaceutical form: Solution for injection Route of administration: Intravenous
15872692|NCT03860844|Drug|Dexamethasone|Pharmaceutical form: Solution for injection or tablet Route of administration: Intravenous or oral
15872693|NCT03860844|Drug|Fludarabine|Pharmaceutical form: Solution for injection Route of administration: Intravenous
15872694|NCT03860844|Drug|Cytarabine|Pharmaceutical form: Solution for injection Route of administration: Intravenous
15872695|NCT03860844|Drug|Liposomal daunorubicin|Pharmaceutical form: Solution for injection Route of administration: Intravenous
15872696|NCT03860844|Drug|Daunorubicin|Pharmaceutical form: Solution for injection Route of administration: Intravenous
15872697|NCT03860844|Drug|Idarubicin|Pharmaceutical form: Solution for injection Route of administration: Intravenous
15872698|NCT03860844|Drug|Filgrastim|Pharmaceutical form: Solution for injection Route of administration: Intravenous
15872699|NCT03860844|Drug|Mitoxantrone|Pharmaceutical form: Solution for injection Route of administration: Intravenous
15872700|NCT03860844|Drug|Doxorubicin|Pharmaceutical form: Solution for injection Route of administration: Intravenous
15872701|NCT03860844|Drug|Vincristine|Pharmaceutical form: Solution for injection Route of administration: Intravenous
15872702|NCT03860844|Drug|PEG Asparaginase|Pharmaceutical form: Solution for injection Route of administration: Intravenous
15872703|NCT03860844|Drug|Cyclophosphamide|Pharmaceutical form: Solution for injection Route of administration: Intravenous
15872704|NCT03860844|Drug|Etoposide|Pharmaceutical form: Solution for injection Route of administration: Intravenous
15872705|NCT03860844|Drug|Methotrexate|Pharmaceutical form: Solution for injection Route of administration: Intravenous
15872706|NCT03860844|Drug|L - Asparginase|Pharmaceutical form: Solution for injection Route of administration: Intramuscular
15872707|NCT03860844|Drug|Hydroxyurea|Pharmaceutical form: Solution for injection Route of administration: Intravenous
15872708|NCT03860844|Drug|L - Asparaginase (Erwinase)|Pharmaceutical form: Solution for injection Route of administration: Intramuscular
15872709|NCT03860844|Drug|Tocilizumab|Pharmaceutical form: Solution for injection Route of administration: Intravenous
15872710|NCT03860831|Drug|Ketamine + midazolam|Group IN received intranasal midazolam (0.2 mg/kg) +ketamine (5mg/kg). Group IM received intramuscular midazolam (0.2 mg/kg) +ketamine (5mg/kg) in the gluteal region.
15872711|NCT03860818|Other|Health services delivery|Technology-enabled pharmacist intervention
15872712|NCT03860805|Procedure|Laparoscopic tubal ligation|Laparoscopic tubal ligation
15872713|NCT03860805|Procedure|Laparoscopic bilateral salpingectomy|Laparoscopic bilateral salpingectomy
15872714|NCT03860792|Behavioral|Ketogenic Diet|Three-month 1:1 ketogenic diet intervention (approximately 70% fat, <10% carbohydrate, and 20% protein).
15872715|NCT03860792|Behavioral|Therapeutic Lifestyles Changes Diet|Three-month diet intervention that is low in fat and cholesterol, high in fruits, vegetables, and whole grains, and moderate in protein.
15872716|NCT03860766|Other|Photobiomodulation|An LED blanket with 267 infrared lamps with predetermined doses will be used, given a wavelength of 940nm, for 5 weeks, it will be applied by all extension of the quadriceps and hamstrings bilaterally, just before the force training protocol for the groups intervention or simulation for the sham group. Photochemical or photophysical effects are expected from its application.
15872717|NCT03860753|Drug|Pioglitazone|For the current trial we will follow recommended adult initial dosing at 30 mg/d to reach maintenance dose of 45 mg/d by week 2, which is within standard titration parameters as per the investigator's brochure.
15872718|NCT03860753|Drug|Placebo|Pill capsules will look same as that of active drug.
15872719|NCT03860740|Other|Exercise|Exercise intervention adapted to maximum rate of oxygen consumption measured during incremental exercise (VO2level) of each patient, working between 60% to 100% VO2level. The activity will be walk-run in a treadmill. 10 sessions minimum
15872720|NCT03860740|Other|Stretching|Stretching and relaxing exercise during 30 minutes. Same number of sessions as intervention group
15872721|NCT03860727|Diagnostic Test|Welch Allyn IExaminer|Fundus Examination
15872992|NCT03858920|Procedure|Low-dose non-contrast CT|CT scan as part of routine research care
15872722|NCT03860714|Diagnostic Test|Neuropsychological tests|We do the neuropsychological tests, Mini-Mental score examination (MMSE),Charlson Comorbidity Index(CCI)，Clinical Dementia Rating(CDR),Quality of Recovery Score - 40 (QoR-40),Geriatric Depression Scale (GDS),CAGE Alcoholism Questionnaire，Pure Tone Audiometry，blood albumin、hemoglobin content、ALT、AST、BUN、Cr、serum folic acid、vitamin B12、homocysteine and branched chain amino acid content 1 day before the surgery（baseline）； 1 day before the surgery（baseline）； Confusion Assessment Method（CAM)，Numerical Rating Scale（NRS）once before discharge from PACU and 1、2、3 days after surgery twice a day； QoR-40 1 day after surgery； Neuropsychological tests and MMSE 6±1 days and one month after surgery.
15872723|NCT03860701|Procedure|Remote ischemic conditioning|An appropriately sized blood pressure cuff will be inflated around a limb (systolic blood pressure + 15 mmHg) for different periods of time (1 to up to 4 minutes), times (1 to up to 4 times) and consecutive days (1 to up to 2).
15872724|NCT03860688|Drug|TED + glucose|Teduglutide, up to 0.05mg/kg, subcutaneous, single dose Glucose, 25g, oral, single dose
15872725|NCT03860675|Diagnostic Test|Assessment of walking-related fatigability|participants perform two six-minute walking test (6MWT), with 3-5 days in between. Before and after the 6MWT, three screenings test (spasticity, muscle strength, balance) are executed and the participants have to indicate the severity of eleven possible symptoms (= symptom inventory, SI) on a VAS scale. These screening tests and SI are continued every 10 minutes for half an hour. During a third test session, participants perform a 6-minute vigilance alphabet test in rest and while doing a 6MWT to investigate the relationship between cognitive and motor fatigability.
15872726|NCT03860662|Diagnostic Test|Nociceptor flexor reflex|The nociceptive flexion reflex (NFR) is a physiological, polysynaptic reflex allowing for painful stimuli to activate an appropriate withdrawal response
15872727|NCT03860662|Drug|Botox|botox
15872728|NCT03860662|Drug|Baclofen|baclofen
15872729|NCT03860649|Other|Nordic Walking|24 sessions will be held twice a week, with each session taking an average of 60 minutes.
15872730|NCT03860649|Other|Jogging|24 sessions will be held twice a week, with each session taking an average of 60 minutes.
15872731|NCT03860649|Other|Dance|24 sessions will be held twice a week, with each session taking an average of 60 minutes.
15872732|NCT03860649|Other|Pilates Training|24 sessions will be held twice a week, with each session taking an average of 60 minutes.
15872733|NCT03860636|Diagnostic Test|Endometrial Pattern on Ultrasound at ET|Ultrasound scan
15872734|NCT03860636|Diagnostic Test|Endometrial Pattern on Ultrasound at HCG|Ultrasound
15872735|NCT03860636|Diagnostic Test|Endometrial Pattern on Ultrasound at TVOR|Ultrasound
15872736|NCT03860636|Diagnostic Test|Endometrial Pattern on Ultrasound at co-ordination scan|Ultrasound
15872737|NCT03860636|Diagnostic Test|Endometrial thickness at HCG|Ultrasound
15872738|NCT03860636|Diagnostic Test|Endometrial thickness at TVOR|Ultrasound
15872739|NCT03860636|Diagnostic Test|Endometrial thickness at ET|Ultrasound scan
15872740|NCT03860636|Diagnostic Test|Endometrial thickness at coordination scan|Ultrasound scan
15872741|NCT03860636|Diagnostic Test|Endometrial volume at HCG|Ultrasound scan
15872742|NCT03860636|Diagnostic Test|Endometrial volume at TVOR|Ultrasound scan
15872743|NCT03860636|Diagnostic Test|Endometrial volume at ET|Ultrasound scan
15872744|NCT03860636|Diagnostic Test|Endometrial volume at coordination scan|Ultrasound scan
15872745|NCT03860636|Diagnostic Test|Blood test for progesterone at HCG|Blood test
15872746|NCT03860636|Diagnostic Test|Blood test for progesterone at TVOR|Blood test
15872747|NCT03860636|Diagnostic Test|Blood test for progesterone at ET|Blood test
15872748|NCT03860636|Diagnostic Test|Blood test for progesterone at coordination scan|Blood test
15872749|NCT03860636|Diagnostic Test|Change in endometrial pattern between TVOR and ET|Ultrasound scan
15872750|NCT03860636|Diagnostic Test|Blood test for estradiol at HCG|Blood test
15872751|NCT03860636|Diagnostic Test|Blood test for estradiol at TVOR|Blood test
15872752|NCT03860636|Diagnostic Test|Blood test for estradiol at ET|Blood test
15872753|NCT03860636|Diagnostic Test|Blood test for estradiol at coordination scan|Blood test
15872754|NCT03860636|Diagnostic Test|Endometrial blood flow (doppler) at HCG|Ultrasound scan
15872755|NCT03860636|Diagnostic Test|Endometrial blood flow (doppler) at TVOR|Ultrasound scan
15872756|NCT03860636|Diagnostic Test|Endometrial blood flow (doppler) at ET|Ultrasound scan
15872757|NCT03860636|Diagnostic Test|Endometrial blood flow (doppler) at coordination scan|Ultrasound scan
15872758|NCT03860636|Diagnostic Test|Contractility at embryo transfer on a subgroup of participants|Ultrasound scan
15872759|NCT03860636|Diagnostic Test|Change in endometrial pattern between coordination scan and ET|Ultrasound scan
15872760|NCT03860636|Diagnostic Test|Change in endometrial pattern between HCG and ET|Ultrasound scan
15872761|NCT03860610|Diagnostic Test|Muscle strength test|Muscle strength in knee flexion and extension and hip abduction will be tested using using a dynamometer (Biodex System 4 Pro: Biodex Medical Systems, Shirley, NY, USA)
15872762|NCT03860610|Diagnostic Test|Dynamic stability test during level and uphill walking|Instrumented gait analysis on an overground walkway with two embedded force plates (Kistler force plate 9260AA6, Kistler AG, Winterthur, Switzerland; sampling rate 2400 Hz) and on a treadmill with an embedded plantar pressure plate (h/p/cosmos, Zebris FDM-T, Isny, Germany)
15872763|NCT03860610|Diagnostic Test|Postural stability test|The overall stability index (OSI) will be assessed using the Biodex Balance System SD (Biodex Medical Systems, Inc., Shirley, NY, USA) and is determined by the variance in platform displacement from the horizontal plane.
15872764|NCT03860610|Diagnostic Test|EuroQol Group Health questionnaire (EQ-5D-5L)|Overall health will be assessed using the EQ-5D-5L health questionnaire
15872765|NCT03860610|Diagnostic Test|HOOS/ KOOS|Site specific pain and function will be assessed with the Hip Osteoarthritis Outcome Score (HOOS) and Knee Injury and Osteoarthritis Outcome Score (KOOS) depending on the affected joint (hip or knee).
15872796|NCT03860428|Other|Expectant Management|Expectative PDA management is character-ized as 'watchful waiting'. No intervention is initiated with the intention to close a PDA.
15872797|NCT03860415|Dietary Supplement|Vivomixx|Two months of 2 sachets vivomixx each morning and 2 sachets each night. Each sachet of viviomixx contains 450 billion live bacteria.
15872766|NCT03860610|Diagnostic Test|Muscle activity test|Surface electrodes (Ag/AgCl, Noraxon, U.S.A. Inc., Scottsdale, AZ, USA: 10 mm diameter, 22 mm inter-electrode distance) will be placed bilaterally on glutaeus medius, vastus medialis, semitendinosus, tibialis anterior, gastrocnemius medialis, and peroneus longus muscles. Periods of muscle activity will be defined as intensity above 2 Standard Deviation (SD) of the resting Electromyography (EMG) signal. Duration of overlapping muscle activity between agonists and antagonists normalized to one gait cycle or of a balance test, respectively, will be determined.
15872767|NCT03860610|Diagnostic Test|Passive range of motion|Passive range of motion will be assessed for ankle plantar-/dorsiflexion, knee flexion/extension and hip flexion/extension, ab/adduction, internal/external rotation using goniometers and recorded in degrees. The range between two maxima will be recorded.
15872768|NCT03860597|Drug|Memantine|To assess the acute effects of MEM (0 vs. 20 mg) on measures of auditory processing fidelity, auditory learning and EAIP, in AP-medicated adult SZ patients and HS.
15872769|NCT03860597|Drug|Placebos|To assess the acute effects of MEM (0 vs. 20 mg) on measures of auditory processing fidelity, auditory learning and EAIP, in AP-medicated adult SZ patients and HS.
15872770|NCT03860584|Dietary Supplement|MFGM-enriched full-fat dairy milk|MetS adults with metabolic endotoxemia will be enrolled to complete a 2-arm, double-blind, randomized controlled, crossover trial to test the independent benefits of MFGM. For each 2-wk arm, they will receive MFGM-enriched full-fat dairy milk (3 servings/d) or a matched dairy milk that instead contains soy phospholipid/lecithin (control). Milks have been formulated with soy lecithin or MFGM at 10% phospholipid (relative to total lipid content). This delivers MFGM at ~10-times that in full-fat dairy milk, which reflects that consumers obtain MFGM from dairy foods other than whole milk.
15872771|NCT03860584|Dietary Supplement|Soy phospholipid/lecithin milk|MetS adults with metabolic endotoxemia will be enrolled to complete a 2-arm, double-blind, randomized controlled, crossover trial to test the independent benefits of MFGM. For each 2-wk arm, they will receive MFGM-enriched full-fat dairy milk (3 servings/d) or a matched dairy milk that instead contains soy phospholipid/lecithin (control). Milks have been formulated with soy lecithin or MFGM at 10% phospholipid (relative to total lipid content).
15872772|NCT03860571|Drug|BT-11 Placebo|BT-11 Placebo (Finished Product),
15872773|NCT03860571|Drug|BT-11 Active|BT-11 active - 500 mg Oral Tablets
15872774|NCT03860558|Other|Lifestyle Intervention|Participants will undergo a 12-week multidisciplinary program for weight control and intensive diabetes management. The program includes adjustments to diabetes medications to enhance weight reduction and improve glycemia, dietary modification, and activity instructions.
15872775|NCT03860558|Other|No Intervention|Participants will not undergo an intervention.
15872776|NCT03860545|Diagnostic Test|urine and blood analysis|concentration of ischemia modified albumin assessed in blood before operation, immediately and one hour after cardiopulmonary bypass, 24 hours after operation; concentration of urinary excretion of brush-border enzymes of the proximal renal tubules assessed before operation, immediately and one hour after cardiopulmonary bypass, 24 hours after operation, serum creatinine levels will be evaluated on the day of the operation and 24 h and 48 h postoperatively
15872777|NCT03860532|Drug|HMPL-011 tablets|Eligible subjects will recieve 1200 mg HMPL-011 tablets under fed and diet circumstance.
15872778|NCT03860532|Drug|HMPL-011 capsules|Eligible subjects will recieve 1200 mg HMPL-011 capsules under fed and diet circumstance.
15872779|NCT03860519|Behavioral|Electronic Medication Monitors on ICS and SABA - Active Mode|"The patients in the intervention group will have sensors that are active, so that these patients receive reminders about when to use their inhalers medications."
15872780|NCT03860519|Behavioral|Electronic Medication Monitors on ICS and SABA - Silent Mode|"The patients in the control group will have sensors that are silent, so that these patients do not receive reminders about when to use their inhalers medications."
15872781|NCT03860519|Behavioral|Asthma App Tracking of ICS/SABA Usage - Active Mode|Patients in the intervention group will have access to their medication usage information (as collected by their sensors) via their Propeller Health applications.
15872782|NCT03860519|Behavioral|Asthma App Tracking of ICS/SABA Usage - Silent Mode|Patients in the control group will not have access to their medication usage information (as collected by their sensors) via their Propeller Health applications.
15872783|NCT03860519|Behavioral|NorthShore Connect Real Time ICS and SABA Usage Feedback - Yes|Patients in the intervention will receive feedback from the Research Nurse about their medication use and asthma control status.
15872784|NCT03860519|Behavioral|NorthShore Connect Real Time ICS and SABA Usage Feedback - No|Patients in the intervention will not receive feedback from the Research Nurse about their medication use and asthma control status.
15872785|NCT03860519|Behavioral|Asthma Nurse Monthly Phone Calls for ICS/SABA Usage Feedback - Yes|Patients in the intervention group will receive monthly calls from the Research Nurse to obtain feedback information about the Propeller Health Platform.
15872786|NCT03860519|Behavioral|Asthma Nurse Monthly Phone Calls for ICS/SABA Usage Feedback - No|Patients in the control group will not receive monthly calls from the Research Nurse to obtain feedback information about the Propeller Health Platform.
15872787|NCT03860506|Drug|PSI-697|
15872788|NCT03860506|Drug|Placebo|
15872789|NCT03860493|Procedure|Perfusion evaluation with indocyanine green|"1. At least 10 minutes before surgery, will receive a weight-scaled dose of indocyanine green by IV and the time of administration and any adverse reactions will be recorded. The Surgeon/researcher will visualize and record the images given by the KARL STORZ VITOM II ICG System and the IC-Flow camera.
~3. The surgery will proceed as planned pre-operatively. The surgeon will conduct the surgery under white light and will categorize initial visualization of the organs."
15872790|NCT03860480|Procedure|ESP with Bupivacaine 0.5%|Regional anesthesia procedure with Bupivacaïne 0.5%
15872791|NCT03860480|Procedure|ESP with Saline 0.9%|Regional anesthesia procedure with Normal Saline
15872792|NCT03860467|Other|collection of patient data|Patient data will be collected using the in-house digital patient record systems and the local digital electroencephalogram (EEG)-database
15872793|NCT03860441|Other|Computerized cognitive training|Intervention used CogniFit platform with Personalized brain training sub-option
15872794|NCT03860428|Drug|Ibuprofen|In the medical treatment arm the in-tention is to close the ductus arteriosus.
15872795|NCT03860428|Drug|Paracetamol|In the medical treatment arm the in-tention is to close the ductus arteriosus.
15872798|NCT03860415|Dietary Supplement|Placebo|Two months of 2 sachets placebo each morning and 2 sachets each night. Each sachet of placebo contains 450 billion live bacteria.
15872799|NCT03860402|Other|Temperature|temperature of drug
15872800|NCT03860389|Other|Exercise|An exercise programme will be delivered in the school for a period of up to 16 weeks. Exercise classes will take place 3 times a week and will be of 60 minutes duration.
15872801|NCT03860363|Device|Blood drainage post cardiac surgery|Blood drainage post cardiac surgery with Thoraguard Surgical Drainage System.
15872802|NCT03860350|Dietary Supplement|Aged Garlic Extract|
15872803|NCT03860350|Dietary Supplement|Placebo|
15872804|NCT03860337|Dietary Supplement|Alginate Sausage|Alginate sausage
15872805|NCT03860337|Other|Control Sausage|Control Sausage
15872806|NCT03860324|Procedure|Single-shot erector spinae plane block|Single-shot Erector Spinae Plane block with 30ml of ropivacaine 0,5% + adrenaline 150mcg.
15872807|NCT03860324|Procedure|Single-shot fascia iliaca block|Single-shot Fascia Iliaca block with 40ml of ropivacaine 0,2%
15872808|NCT03860311|Device|Bladder Ultrasound|"Bladder fullness will be assessed upon enrollment and if not full, the patient will receive hydration, determined by treating physician, and the bladder ultrasound will be repeated every 30 minutes until the patient states that the bladder is full, or until bladder is deemed full based on a previously validated bladder fullness qualitative scale, at which point patients in this group will proceed to undergo pelvic ultrasound."
15872809|NCT03860311|Other|Standard of Care|Per institution protocol, patients in the standard of care group will have urethral (bladder) catheter placed immediately after the order for pelvic ultrasound and will undergo retrograde bladder filling as determined by the radiologist/ultrasonographer to the point necessary to fully visualize pelvic structures.
15872810|NCT03860298|Device|NaviFUS System|Using NaviFUS System treatment for 10 minutes in drug resistant epilepsy. The site of the NaviFUS exposure is where the future surgery will be removed. Patients will concomitant use of anti-epileptic drugs (AEDs).
15872811|NCT03860285|Other|Short form 36 quality of life survey|Prospective non-comparative observational study of cohorts
15872812|NCT03860272|Drug|AGEN1181|An Fc-Engineered Anti-CTLA-4 Monoclonal Antibody
15872813|NCT03860272|Drug|AGEN1181|An Fc-Engineered Anti-CTLA-4 Monoclonal Antibody
15872814|NCT03860272|Drug|AGEN2034|A fully human monoclonal Anti-PD-1 Antibody
15872815|NCT03860259|Device|Auriculotherapy cryopuncture device without nitrogen gas|Auriculotherapy cryopuncture device without nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy
15872816|NCT03860259|Device|Auriculotherapy cryopuncture device with nitrogen gas|Auriculotherapy cryopuncture device with nitrogen gas will be administered. In addition, an interscalene block will be performed as well as standard of care treatment for surgery, post-operative pain management and physical therapy
15872817|NCT03860246|Diagnostic Test|Portable ECG monitor|Recording of ECG rhythm on a portable monitor (Kardia Mobile)
15872818|NCT03860233|Drug|Oxytocin|40 IU administered intranasal, within 1 hour prior to sleeping for 14 days
15872819|NCT03860233|Drug|Placebo|Intranasal spray to mimic Oxytocin intranasal spray
15872820|NCT03860220|Drug|NEWSTATIN TS|Wash out/run in period with Amlodipine 5mg for 6 weeks and then treatment with triple therapy (Newstatin TS 40/5/10mg) ; 1 tab qd for 8 weeks
15872821|NCT03860220|Drug|CADUET|Wash out/run in period with Amlodipine 5mg for 6 weeks and then treatment with dual therapy (Caduet 5/10mg) ; 1 tab qd for 8 weeks
15872822|NCT03860207|Biological|Humanized 3F8 Bispecific Antibody|Phase I Hu3F8-BsAb is given IV over ~1-3 hours on Days 1 and 8 for each cycle.Phase II Hu3F8-BsAb is given IV over ~1-3 hours on Days 1 and 8 for each cycle.
15872823|NCT03860207|Other|Blood draw|In cycle 1, blood is drawn for PK studies.
15872824|NCT03860194|Dietary Supplement|Protison with High Protein 51(Original Flavor)|Contents of each supplement sachet has a calorie of 88 kcal, 12.8 g protein( including 8.5 g whey protein concentrate), 1.2 g leucine, 7.3 g carbohydrates, 0.8 g fat and 120 IU vitamin D per serving. This supplement was added 200 ml water and stirred well, then drank before meal.
15872825|NCT03860181|Procedure|Subcuticular Sutures - Surgeon 1|This intervention closes incisions after shoulder arthroplasty using subcuticular sutures with Dermabond.The deep layer closure will require interrupted sutures.
15872826|NCT03860181|Procedure|Metal Staples - Surgeon 2|This intervention closes incisions after shoulder arthroplasty with metal staples. The deep layer closure will require interrupted sutures,
15872827|NCT03860181|Device|PRINEO - Surgeon 1|The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
15872828|NCT03860181|Device|PRINEO - Surgeon 2|The closure system uses the Dermabond PRINEO (which is similar to clear tape stuck over the wound) placed over running sutures for both the deep and subcuticular layer.
15872829|NCT03860168|Other|PICU Up!|The PICU Up! intervention is a multifaceted mobility program incorporating the ABCDEF bundle components into routine PICU care through multidisciplinary staff education and a structured pathway to determine a patient's daily mobility goal. PICU Up! was developed by a collaborative multidisciplinary team approach, and the central components include the consultation and involvement of physical therapy/occupational therapy (PT/OT) by PICU Day 3, sleep hygiene promotion and routine delirium screening for all PICU patients utilizing a validated tool.
15872830|NCT03860155|Biological|allo-APZ2-ACLF|Administration of 2 x 10e6 allogeneic ABCB5-positive stem cells/kg bodyweight, each at Day 0, Day 5 (±1) and Day 13 (±1) into peripheral vein (arm) intravenously with a flow rate of 1-2 ml/min. Infusion of the product via a central venous catheter (CVC), a Port-a-Cath (Port) or a similar catheter is also possible. Allo-APZ2-ACLF will be in a concentration of 1 x 10e7 cells/mL in Human Serum Albumin/Ringer-Lactate/Glucose (HRG)-solution.
15872831|NCT03860142|Behavioral|Archet scale|Parents will be asked to answer questions about their child's nutrition by using a new scale : Archet scale
15872832|NCT03860129|Drug|Isoflurane|Group A: Isoflurane (0.5 MAC)
15872833|NCT03860129|Drug|Sevoflurane|Group B: Sevoflurane (0.5 MAC)
15872834|NCT03860129|Drug|Desflurane|Group C: Desflurane (0.5 MAC)
15872956|NCT03859102|Drug|Infiltration of surgical wounds with local anaesthetic|Infiltration of surgical wounds with local anaesthetic at the end of surgery, Bupivacaine 1-2mg/kg.
15872835|NCT03860116|Behavioral|APP-based case management service|The intervention consists of 4 parts, educational articles, online communication with case managers, supportive service information and visit reminder. Educational articles are both delivered automatically and retrieved by participants. Online communication can also be initiated by participants and case managers. Case managers are request to respond to questions from participants as well as care about medication taking behaviors of each patients during the first month. Supportive service information, which include time, location and charges of service providers will be retrieved by participants, with reminders of available service information scheduled at the beginning of every month. Visit reminders are scheduled at one week before due date.
15872836|NCT03860116|Behavioral|Standard-of-care followup service|When participants initiate HIV antiretroviral treatment (ART), they receive 20-minute ART-related education from the case managers, and have physical examination including blood test, CD4 count, hepatic and renal function tests. Subsequent visits are scheduled at month 1, 2, 3, 6 and 12. During each visit, pills enough to cover days until the next visit will be distributed. And patients will be asked about their medication adherence, high risk behavior and side effects experienced. Any relevant questions from patients will be answered. Physical tests are also included in the routine of each visits.
15872837|NCT03860090|Device|Pacemaker implant|Implantation of endovenous cardiac stimulation device.
15872838|NCT03860090|Device|Defibrillator implant|Implantation of endovenous cardiac defibrillation device.
15872839|NCT03860090|Procedure|AXILLARY VEIN ACCESS|Fluoroscopy-guided axillary puncture to get vein access
15872840|NCT03860090|Procedure|CEPHALIC VEIN ACCESS|Optimized cephalic vein cutdown to get vein access
15872841|NCT03860077|Drug|Very Low Nicotine Content Cigarettes|Very Low Nicotine Content Cigarettes
15872842|NCT03860077|Drug|Normal Nicotine Content Cigarettes|Normal Nicotine Content Cigarettes
15872843|NCT03860064|Other|Non intervention|Non
15872845|NCT03860025|Other|No intervention.|No intervention.
15872846|NCT03860012|Drug|Folic Acid|Patients on daily folic acid with a normal baseline folate level will be switched to once weekly dosing.
15872847|NCT03859999|Diagnostic Test|Analysis of primary radiograph and available demographics|Multivariate analysis of the fracture x-ray features measured by computer, together with the database demographic and outcome data will be used to develop the best model /decision rule to predict likelihood of MUA success
15872848|NCT03859986|Drug|ALX-101 Gel Vehicle|ALX-101 Gel Vehicle
15872849|NCT03859986|Drug|ALX-101 Gel 5%|ALX-101 Gel 5%
15872852|NCT03859960|Diagnostic Test|body composition|fat mass % (FM%) and fat-free mass (FFM%)% of arms, legs, trunk, android, gynoid and total body
15872853|NCT03859960|Diagnostic Test|glucose, insulin, glycohemoglobin|In the morning after 12 hours overnight fast, all individuals underwent a 75 gram (g) oral glucose tolerance test (OGTT). Blood samples were taken before loading glucose and then 30, 60, 90 and 120 minutes after taking glucose solution in order to measure serum glucose and insulin levels. Glycohemoglobin (HbA1c) was measured in blood samples taken before the OGTT. We calculated the Matsuda index and Homeostasis model assessment index (HOMA-IR) using glucose and insulin levels.
15872854|NCT03859947|Device|Heated humidiﬁed high-flow nasal cannula|Non-invasive ventilation with a nasal cannula
15872855|NCT03859934|Drug|Melatonin|Melatonin treatment
15872856|NCT03859934|Drug|Placebo Oral Tablet|Placebo treatment
15872857|NCT03859921|Drug|Dydrogesterone|Progesterone
15872858|NCT03859921|Drug|Placebo|Placebo with appearance similar to Dydrogesterone
15872859|NCT03859908|Drug|Iodine Povacrylex 7 MG/ML / Isopropyl Alcohol 0.74 ML/ML|As preoperative antiseptic, applied once as suggested by Centers for Disease Control recommendations in surgical asepsis
15872860|NCT03859908|Drug|Chlorhexidine Gluconate 20 MG/ML / Isopropyl Alcohol 0.7 ML/ML|As preoperative antiseptic, applied once as suggested by Centers for Disease Control recommendations in surgical asepsis
15872861|NCT03859882|Other|Sleep deprivation|40 hours of continuous awaking in the sleep laboratory in order to compare before and after sleep deprivation for each treatment (Caffeine vs. placebo).
15872862|NCT03859869|Drug|Pancrelipase|Pancrelipase is administered orally as capsules with a meal or snack
15872863|NCT03859869|Drug|Placebo|Placebo is administered orally as capsule with a meal or snack
15872864|NCT03859856|Other|hormone panel and ultrasonography|Blood sampling on the 3rd day of menstrual cycle for the measurement of serum FSH, LH, E2 and AMH hormone levels and ultrasonography for antral follicle count and ovarian volume measurement will be done.
15872865|NCT03859843|Combination Product|PRP|Ten mL of venous blood will be drawn in a syringe fill with 1.5 mL of anticoagulant solution (anticoagulant citrate dextrose solution formula A, Baxter, Deerfield, IL). The blood will be centrifuged at 160 g for 10 minutes. After the first spin, the lower red blood cell portion will be discarded, and the supernatant will be centrifuged at 400 g for 10 minutes. The resulting pellet of platelets will be mixed with 1.5 mL of supernatant, which make 1.5 mL of PRP. One mL of 3% calcium chloride will be added to the PRP to induce platelet activation.
15872866|NCT03859843|Other|Chemical peeling (Salycilic acid)|SA is a 2-hydroxybenzoic acid (from willow tree) used for superficial peeling due to its strong keratolytic and comedo- lytic properties. It promotes shedding of epidermal cells and due to its lipophilic properties can penetrate comedones and pores to prevent clogging and neutralize bacteria. It promotes desquamation of the upper lipophilic layers of the stratum corneum.19 These chemical properties explain its popularity and success in acne patients.It also has well- documented anti-inflammatory properties.
15872867|NCT03859843|Other|Chemical peeling (Jessener's solution)|is a superficial peeling agent used as adjuvant therapy for acne. it is generally proposed to break of the hydrogen bonds of keratin (keratolysis), disruption of cell membranes (cell death) and is bactericidal.
15872868|NCT03859830|Device|Artis Dialysis System, ArtiSet PrePost and Ultra HDF Line|The HDF session will be performed in post-dilution volume-controlled mode, with a minimum target total convective volume (VCtot) of 16 L and blood flow rate (QB) set at 200-300 mL/min.
15872869|NCT03859830|Device|AK200 Ultra S, extracorporeal circulation conduct of blood purification|The HDF session will be performed in post-dilution volume-controlled mode, with a minimum target total convective volume (VCtot) of 16 L and blood flow rate (QB) set at 200-300 mL/min.
15872870|NCT03859817|Other|Comparison of eGFR values and ketonemia in diabetic patients|To verify if there is a correlation between the level of ketones and an alteration of the renal function in the diabetic patient, the values of the prognostic markers indicated in the protocol and the data downloaded by the glucometers will be evaluated in addition to the blood tests of the patients
15872871|NCT03859804|Procedure|Standard transrectal 12 core biopsy|TRUS-guided SPB was performed by obtaining 12 core samples in each patient. 6 cores from left and right. the cores labeled as, apex, mid, base, apex far lateral, mid far lateral and base far lateral
15872872|NCT03859804|Procedure|MRI- US fusion prostate biopsy (FPB)|FPB was performed by obtaining 10-12 core samples in each patient, followed by the acquisition of 2-4 core samples for each suspected lesion detected on MpMRI (combined biopsy)
15872873|NCT03859791|Other|THA|Study participants have received a total hip arthroplasty due to arthritis. We do not make further intervention.
15872874|NCT03859778|Other|survey|French pharmacy students will be contacted by email thanks to the student associations and scolarity departments. Answer to the survey will be done online
15872875|NCT03859765|Behavioral|HCT Symptoms and Steps|HCT Symptoms and Steps will provide patients with cognitive behavioral coping skills training and activity coaching sessions to enhance their ability to manage symptoms that interfere with activity.
15872876|NCT03859752|Biological|TR1801-ADC|Humanized anti-c-Met monoclonal antibody conjugated to a cleavable pyrrolobenzodiazepine toxin
15872877|NCT03859739|Drug|MK-8558|Single dose of MK-8558 administered as a tablet at a dose up to 1600 mg.
15872878|NCT03859726|Diagnostic Test|NIRS|Near-infrared spectroscopy (NIRS) offers non-invasive, in-vivo, real-time monitoring of tissue oxygenation. Changes in regional tissue oxygenation as detected by NIRS may reflect the delicate balance between oxygen delivery and consumption.
15872879|NCT03859726|Diagnostic Test|Sublingual microcirculation|The sidestream dark field (SDF) imaging devices provide high contrast images of the microvasculature.
15872880|NCT03859713|Behavioral|Physical Therapy|Evidence-based physical therapy provided in 8 individual sessions including patient education, exercise instruction and manual therapy.
15872881|NCT03859713|Behavioral|Cognitive Behavioral Therapy|Evidence-based cognitive behavioral therapy provided in 8 individual sessions focused on key components of CBT; 1) identifying and monitoring maladaptive cognitions, 2) developing coping strategies (e.g., distraction, relaxation, etc.), 3) setting and working towards behavioral goals, especially focused on physical activity, and 4) focusing on self-management skills and home instruction
15872882|NCT03859713|Behavioral|Mindfulness|Mindfulness is provided in 8 individual sessions. Focus of sessions is cognitive reappraisal, positive savoring and mindfulness practices.
15872883|NCT03859700|Biological|DBV712 250 mcg|DBV712 250 mcg, once daily
15872884|NCT03859687|Biological|Vitamin A supplementation|liquid oral vitamin A supplementation
15872885|NCT03859687|Biological|No vitamin A supplementation|No vitamin A supplementation
15872886|NCT03859661|Dietary Supplement|Fitabisc|Fitabisc is a chocolate cookie with vanilla cream filling which contains the most important antioxidants Vitamin C, Vitamin E, and the mineral Selenium. Fitabisc is not commercially available and for the purposes of this study it will be manufactured by Calerrific Ltd, which already produces a biscuit called CalBisc 100 as a simple calorie and nutritional supplement. Production takes place in a BRC Global Standard Grade A certified bakery operated by Farringford Foods in Portadown, Northern Ireland.
15872887|NCT03859648|Device|BONEBRIDGE|Bone Conduction Implant
15872888|NCT03859635|Drug|Liposomal Bupivacaine|20 ml
15872889|NCT03859635|Drug|Bupivacaine, 0.25%|10 ml
15872890|NCT03859635|Drug|Bupivacaine, 0.5%|30 ml
15872891|NCT03859609|Procedure|Spinal Fusion|Spinal alignment was evaluated according to two different score-systems
15872892|NCT03859596|Procedure|MGB/OAGB|BARIATRIC PROCEDURE INVOLVED CREATION OF SLENDER GASTRIC POUCH OF 12-15CM IN LENGTH AND BILIO-PANCREATIC LIMB OF 150-200 CM
15872893|NCT03859583|Dietary Supplement|Capsaicin|4 tsp of cayenne in a breakfast omelette
15872894|NCT03859583|Dietary Supplement|Control|breakfast omelette without cayenne pepper
15872895|NCT03859570|Drug|Pentoxifylline|Pentoxifylline (PTX) is a methylxanthine derivative that is a nonselective inhibitor of cyclic nucleotide phosphodiesterase (PDE). This enzyme, which has at least 5 subtypes, is responsible for inactivation of the important second messengers, Cyclic adenosine monophosphate (AMP) and cyclic guanosine monophosphate (GMP)
15872896|NCT03859570|Drug|Placebos|Placebo
15872897|NCT03859544|Other|Retrospective study|Retrospective study to search mutations associated with Central nervous system lymphoma and study of the prognostic impact (overall survival and progression-free survival) of these mutations.
15872898|NCT03859518|Other|blood and skin samples|To study the presence and type of ILC and NK in the blood and skin of vitiligo patients compared to control subjects.
15872899|NCT03859505|Device|Placebo PBMT|The PBMT treatments will be performed using the Multi Radiance Medical™ Super Pulsed Laser MR4™console (Solon, OH, USA), with the LS50 (emitter with an area of 20 cm2) and SE25 (emitter with an area of 4 cm2) cluster probes as emitters. Nine sites will be irradiated at patient's lumbar region: 3 central sites, using the SE25 (without any dose, 0 J); and 6 sites in the same direction, but laterally (both sides, 3 at a side), using the LS50 (without any dose, 0 J). Patients will be treated in a single session and they will receive a total dose of 0 J.
15872900|NCT03859505|Device|Active PBMT|The PBMT treatments will be performed using the Multi Radiance Medical™ Super Pulsed Laser MR4™ console (Solon, OH, USA), with the LS50 (emitter with an area of 20 cm2) and SE25 (emitter with an area of 4 cm2) cluster probes as emitters. Nine sites will be irradiated at patient's lumbar region: 3 central sites, using the SE25 (3000 Hz of frequency, 3 minutes of irradiation per site, 24.75 J per site, a totalizing 74.25 J irradiated from SE25); and 6 sites in the same direction, but laterally (both sides, 3 at a side), using the LS50 (1000 Hz of frequency, 3 minutes of irradiation per site, 24.30 J per site, a total of 145.80 J irradiated from LS50). Patients will be treated in a single session and will receive a total dose of 220.05 J.
15872901|NCT03859492|Device|Contrast Enhanced Digital Mammography|High-resolution, low-energy, full-field digital mammography (FFDM) image and contrast-enhanced image
15872902|NCT03859479|Procedure|Cold snare polypectomy|After a target polyp was identified, it should be placed at the comfortable position. Then the snare will be opened and encircled the polyp without air aspiration. Then, the snare will be captured the polyp with at least 1-2 mm of surrounding normal tissue. The polyp will be guillotined and would not be lifted or tented until complete closure is achieved. After resection, the mucosal defect the marginal mucosa was carefully observed, with used of magnification and image enhancement. If residual polyp tissue was recognised, additional removal using the cold snare technique or biopsy forceps will be performed. If a submucosal injection prior to snaring was necessary it will be permitted. After polypectomy all patients will be observed for 3-4 days in-hospital
15872903|NCT03859479|Procedure|Hot snare polypectomy|After a target polyp was identified, it should be placed at the comfortable position. Then the polyp with minimal normal tissue will be captured by the snare. The ensnared polyp should be tented away from the colonic wall and removed by one the types of electric currents. After resection, the mucosal defect will be washed thoroughly and the marginal mucosa was carefully observed, with used of magnification and image enhancement, such as near focus imaging or narrow band imaging. If a submucosal injection prior to snaring was necessary it would be permitted. If residual polyp tissue was recognised, additional removal using coagulation or biopsy forceps will be performed. After polypectomy all patients will be observed for 3-4 days in-hospital
15872904|NCT03859466|Device|Shockwave Therapy|"Surgically invasive device, transient use only for the time of surgical intervention, intended for use in direct contact with the heart, intended to correct defect of the heart.
~Throughout the study, investigators are permitted to use their clinical judgement when prescribing concomitant medications and treatments for trial patients. Local prescribing information and institutional guidelines should be followed as applicable"
15872905|NCT03859440|Device|DSiHy Silicone hydrogel soft contact lens|•Device: DSiHy (test lens) Silicone hydrogel soft contact lens for daily disposable wear.
15872906|NCT03859440|Device|CE-marked Silicone hydrogel soft contact lens|"・Device: Silicone hydrogel soft contact lens CE-marked for daily disposable wear.
~Other Name : MyDay"
15872915|NCT03859401|Device|EnMPC (Ensemble Model Predictive Control) AP Controller|This AP controller has the ability to anticipate exercise activity by use of trends seen during the Data Collection Period.
15872916|NCT03859401|Device|rMPC (Naïve Model Predictive Control) AP Controller|This AP controller does not have the ability to anticipate exercise activity.
15872917|NCT03859375|Other|microbial skin counts in the disinfection area after paints of skin disinfectants|microbial skin counts in the disinfection area after 2 and 3 paints of skin disinfectants (chlorhexidine in alcohol [CHX] and povidone iodine in alcohol [PI])
15872918|NCT03859362|Drug|Ertapenem Injection|1 g of ertapenem q24h, 30 min infusion
15872919|NCT03859349|Diagnostic Test|Selective Targeted Sampling|After CLNS assessment, patients with proven malignant mediastinal lymph nodes will be referred for chemoradiation and patients with proven benign mediastinal lymph nodes will undergo surgical resection as per standard of care guidelines. Final pathology from the resected specimen will be considered the gold standard for analysis of sensitivity and specificity.
15872920|NCT03859349|Diagnostic Test|Systematic Sampling|Following routine biopsy of lymph nodes, patients with proven malignant mediastinal lymph nodes will be referred for chemoradiation and patients with proven benign mediastinal lymph nodes will undergo surgical resection as per standard of care guidelines. Final pathology from the resected specimen will be considered the gold standard for analysis of sensitivity and specificity.
15872921|NCT03859336|Device|Transdermal Neuromodulation Stimulation|The TEN device administers a tuned high frequency electrical stimulation delivered to the cervical plexus (C2-C4) on the back of the neck for 20 minutes. This stimulation will activate common trigeminovagal pathways modulating noradrenergic signaling to attenuate sympathetic activity. This stimulation can subsequently regulate the activity of several deep-brain nuclei within the ascending reticular activating system (RAS). Nuclei in the RAS regulate powerful neuromodulators like norepinephrine (NE), acetylcholine (ACh), and serotonin (5-HT). The investigators will examine whether this modulation from TENS will decrease anxiety and improve sleep quality in the study participants.
15872922|NCT03859323|Drug|SHP681|Participants will receive SC injection of SHP681 in the abdomen.
15872923|NCT03859323|Other|Placebo|Participants will receive SC injection of placebo matched to SHP681 in the abdomen.
15872924|NCT03859310|Device|SD-OCT|Spectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures
15872957|NCT03859102|Drug|Intravenous Magnesium intra-operatively|One infusion of intravenous Magnesium Sulphate intra-operatively as an analgesic, 50mg/kg given over 30minutes.
15872958|NCT03859102|Drug|Post-operative Gabapentin analgesia|Post-operative oral Gabapentin 300mg, three times daily as an analgesic.
15872959|NCT03859102|Drug|Post-operative oral Paracetamol analgesia|Post-operative Paracetamol as an analgesic. Initially intravenously, then orally. One gram four times daily.
15872991|NCT03858920|Device|Fibroscan of Liver|A non-invasive diagnostic device used to measure liver scarring
15872925|NCT03859297|Behavioral|Rumination-Focused CBT|"RF-CBT targets rumination and other maladaptive forms of emotion regulation such as suppression and avoidance and provides skills training in effectively coping with rumination. RF-CBT specifically targets rumination through psychoeducation, adopting a functional analytic approach to the learned habitual behavior of rumination, and a focus on shifting process style. The adolescent is taught to notice triggers to ruminate as well as the consequences of rumination and to shift into practicing a more adaptive strategy such as an attention training exercise, behavioral activation, thinking in a concrete way, or active problem-solving. RF-CBT directly teaches adolescents to recognize rumination or when the participant gets stuck in their head and to notice the influence this has on their mood."
15872926|NCT03859297|Behavioral|Relaxation-based Therapy|Sessions will include progressive muscle relaxation, simple breathing techniques, and guided imagery that focus on bodily and somatic relaxation. Adolescents randomized to Relaxation Therapy (RelaxT) will also receive exercises to do as homework in between sessions, parallel to the RF-CBT group.
15872927|NCT03859284|Other|flowable resin composite|gold standard
15872928|NCT03859284|Other|self adhering flowable|moist bonding self adhering flowable composite
15872929|NCT03859284|Other|self adhering flowable with adhesive|moist bonding self adhering flowable composite with the aid of an adhesive system.
15872930|NCT03859271|Behavioral|Brief motivational interviewing|Children and parents will receive BMI and instant messaging delivered by a trained research nurse. At the time of recruitment, both children and parents will receive an education talk on the significance of and misconceptions about regular physical activity for cancer survivors and strategies for overcoming barriers to engaging in physical activity. Parents will then receive a face-to-face BMI to motivate their children to engage in regular physical activity. Parents will also be encouraged to motivate their children to intensify their physical activity levels progressively, with the ultimate goal of achieving the Global Recommendations on Physical Activity on Health suggested by the World Health Organization. Additionally, they will be invited to download a mobile health application from the Centre for Health Protection, Department of Health, HKSAR website that contains information on physical activity.
15872931|NCT03859271|Behavioral|Placebo control|Children and parents will receive the education talk on physical activity and ask to download the mobile health application that contains information on physical activity at the time of recruitment similar to the intervention group. However, parents will not receive BMI and instant messaging throughout the study period.
15872933|NCT03859245|Behavioral|Photobiomodulation|Photobiomodulation therapy, via Joovv red light/infrared LED device, three days/week, 20 minutes per session for experimental and control groups.
15872934|NCT03859245|Behavioral|Ketogenic diet|Experimental group will follow a clinically prescribed ketogenic diet.
15872935|NCT03859232|Other|Delta Dry® Waterproof Pantaloon|Cast with newer waterproof material developed to reduce the skin complications associated with traditional cotton liners.
15872936|NCT03859232|Other|Cotton Padding|Cast with traditional cotton liner.
15872937|NCT03859219|Drug|Rozanolixizumab|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous infusion"
15872938|NCT03859219|Drug|Placebo|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous infusion"
15872939|NCT03859206|Other|Medical thoracoscopy|• With the closed biopsy forceps, step by step, fibrinous septae were perforated, the pleural space was irrigated with saline and fluid and fibrinopurulent material were aspirated and removed from the pleural cavity, the entire pleural cavity was inspected and biopsies were obtained from suspicious areas carefully by the biopsy forceps under vision. Multiple lesions were encountered, multiple biopsies were taken & If no lesion, biopsy from parietal pleura was obtained from any sites.
15872940|NCT03859193|Behavioral|Nutritional Video|A 10 - 15 minute video
15872941|NCT03859180|Behavioral|Focused breathing|Focused breathing is a series of focused, controlled breaths that aid in relaxation. Each participation in this group will be taught how to do focused breathing by the study investigator. Once determined to be able to perform focused breathing, participants will be asked to practice it for 4 minutes, twice a day, for 6 weeks. If they choose to do so, they may practice focused breathing if they become anxious at other times. They will be asked to keep a diary of each time they practice and/or use focused breathing.
15872942|NCT03859167|Other|Stress Test|Participants will reach maximum exercise on a treadmill and results will be collected and recorded.
15872943|NCT03859141|Biological|Quadrivalent influenza vaccine|One dose of quadrivalent influenza vaccine: 0.25 ml per dose containing 7.5μg antigen.
15872944|NCT03859141|Biological|Quadrivalent influenza vaccine|One dose of quadrivalent influenza vaccine: 0.25 ml per dose containing 7.5μg antigen.
15872945|NCT03859141|Biological|Trivalent influenza vaccine (contains B/Victoria strain)|One dose of trivalent influenza vaccine (contains B/Victoria strain): 0.25 ml per dose containing 7.5μg antigen.
15872946|NCT03859141|Biological|Trivalent influenza vaccine (contains B/Yamagata strain)|One dose of trivalent influenza vaccine (contains B/Yamagata strain): 0.25 ml per dose containing 7.5μg antigen.
15872947|NCT03859128|Biological|TORIPALIMAB INJECTION(JS001 )|Arm A: Toripalimab 240mg IV(Injection of Vein) Q3W Arm B: Placebo 240mg IV(Injection of Vein) Q3W
15872948|NCT03859115|Procedure|TENS (transcutaneous electrical nerve stimulation)|transcutaneous nerve stimulation with electrical pulse generation
15872949|NCT03859115|Procedure|sham intervention|sham stimulation without electrical pulse generation
15872950|NCT03859102|Dietary Supplement|Pre-operative Carbohydrate PreLoad drink|Pre-operative Carbohydrate PreLoad drink, 1 sachet given the night before surgery. One sachet given 2-4hours before surgery.
15872951|NCT03859102|Drug|Oral Gabapentin pre-op|One dose of Gabapentin pre-operatively, 300mg orally.
15872952|NCT03859102|Drug|Oral Lansoprazole pre-op|One dose of Lansoprazole pre-operatively, 30mg orally.
15872953|NCT03859102|Drug|Intravenous Paracetamol intra-operatively|One dose of Paracetamol intra-operatively, 1gram intravenous infusion.
15872954|NCT03859102|Drug|Intravenous Dexamethasone intra-operatively|One dose of Dexamethasone intra-operatively as an anti-emetic, 8mg intravenous.
15872955|NCT03859102|Drug|Intravenous Ondansetron intra-operatively|One dose of Ondansetron intra-operatively as an anti-emetic, 4mg intravenous
15872989|NCT03858933|Device|eBrainFit Platform|Alpha/Theta regulation with eyes open
15872960|NCT03859102|Drug|Post-operative Ondansetron anti-emesis|Intravenous Ondansetron administered post-operatively as prophylactic anti-emesis. 4mg three times daily, for 24 hours. Then as required.
15872961|NCT03859102|Procedure|Early extubation|Removal of the endotracheal tube in the Intensive Care Unit as soon as is safe.
15872962|NCT03859102|Procedure|Early mobilisation/physiotherapy|Mobilisation (active and passive limb movements, deep breathing) with the assistance of nurse/physiotherapist to occur as soon as possible post-operatively.
15872963|NCT03859102|Other|Encourage early oral food intake|Patients will be encouraged to start eating as soon as possible post-operatively
15872964|NCT03859089|Other|Medical Cannabis|N/A - Observational Cohort Study
15872965|NCT03859076|Behavioral|MB-BP|MB-BP customizes Mindfulness-Based Stress Reduction (MBSR) to participants with hypertension. It consists of nine 2.5-hour weekly group sessions & a 7.5-hour one-day session. Content includes education on hypertension risk factors, hypertension health effects, & specific mindfulness modules focused on awareness of BP determinants such as diet, physical activity, anti-hypertensive medication adherence, alcohol consumption, & stress reactivity. Students learn a range of mindfulness skills (body scan exercises, meditation and yoga). Participants are given a home BP monitor. Participants with uncontrolled hypertension are offered to have their physicians notified; for those without a physician, the investigator works to provide access within health insurance constraints.
15872966|NCT03859076|Other|Enhanced Usual Care Control|Those in the control group receive an educational brochure from the American Heart Association (product code 50-1731) and a validated home blood pressure monitor (Omron, Model PB786N), that has an evidence-based approach to lower blood pressure. All participants who have uncontrolled hypertension (blood pressure >140/90 mmHg) will be offered to have their physicians notified, if not already being overseen for it. For participants with uncontrolled hypertension who do not have a physician, the investigator works to provide access within constraints of their health insurance. Additionally, participants randomized to the control group are asked to refrain from engaging in any type of formal mindfulness practice more than weekly during the first six months of study involvement.
15872967|NCT03859063|Behavioral|Intervention|Participants randomized to the intervention arm will be followed with monthly meetings by a stroke coordinator for 18 months. The stroke coordinator will assess the patients risk factors within the domains of physical function, cognitive function, social function, medication and lifestyle factors and make a treatment plan targeting the individual needs for further follow-up.
15872968|NCT03859063|Behavioral|Control|Community based follow-up as usual
15872969|NCT03859050|Other|bronchoscopy with intrabronchial administration of lipopolysaccharide|The PI will administer intrabronchial LPS into the lungs of healthy volunteers and then obtaining macrophages by bronchoalveolar lavage (BAL) 24, 48, 72, 96, or 120 hours later.
15872970|NCT03859037|Other|Umbilical cord milking|100 babies will have squeezing of blood from umbilical cord towards baby
15872971|NCT03859024|Drug|Oxycodone|oxycodone tablet
15872972|NCT03859024|Drug|Acetaminophen|acetaminophen tablet
15872973|NCT03859024|Drug|Gabapentin|gabapentin tablet
15872974|NCT03859024|Drug|celebrex|Celebrex tablet
15872975|NCT03859024|Drug|Bupivacaine|bupivacaine injection
15872976|NCT03859024|Drug|Ibuprofen 800 mg|ibuprofen tablet
15872977|NCT03859024|Drug|Dexamethasone|Dexamethasone injection
15872978|NCT03859011|Other|Acupuncture|"Patients will have DBC Spring Ten acupuncture needles (manufactured in China) manually inserted bilaterally on five standardized acupuncture points according to the treatment points of GB20, BL10, BL11, SI3, BL62 at 6-8 mm depth for 20 minutes each using a tonification technique to elicit a de qi response.
~After those needles are removed, the number of additional needles and additional acupuncture points used will be chosen at the acupuncturist's discretion."
15872979|NCT03859011|Other|Usual Care|Physical therapy, oral medications and topical ointments pre the discretion of the primary physician
15872980|NCT03858998|Other|Case Management Intervention|A 90-day case management intervention to link hospitalized HIV-infected participants with local HIV clinics.
15872981|NCT03858998|Other|Control|Current routine HIV care in Tanzania.
15872982|NCT03858985|Device|Cervical Transcutaneous Vagus Nerve Stimulation (Active Comparator)|Both sham and active nVNS treatment produce low-voltage electrical signal that induce reliable sensation on subject skin on upper anterior cervical area (overlying carotid artery).
15872983|NCT03858985|Device|Cervical Transcutaneous Vagus Nerve Stimulation (Sham Comparator)|Both sham and active nVNS treatment produce low-voltage electrical signal that induce reliable sensation on subject skin on upper anterior cervical area (overlying carotid artery).
15872984|NCT03858972|Drug|Tesetaxel|Tesetaxel plus reduced dose of capecitabine
15872985|NCT03858972|Drug|Capecitabine|Reduced dose of capecitabine
15872986|NCT03858959|Device|topical agent|"HBX protocol consisted in product application into the periodontal pocket (starting from the base) with a delivery syringe, second saline solution irrigation after 60 seconds to flush-out the product and Teflon-curettes debridement to remove the deposits.
~CHX protocol consisted in Teflon-curettes debridement to remove the deposits, associated with a first saline solution irrigation, and product application into the periodontal pocket (starting from the base) with a delivery syringe."
15872987|NCT03858946|Procedure|Simple trapeziectomy|A curvilinear incision is made over the base of the 1. metacarpal towards the tendon of the extensor pollicis brevis in the distal part of the anatomical snuffbox. The joint is opened as widely as possible and the trapezium is dissected free in a proximal direction until the articulation with the scaphoid is reached. Then trapezium is removed taking care not to damage tendon of the flexor carpi radialis. The joint capsule is closed and skin sutured in the usual manner. At the completion of the procedure two small shame incision are made (1 cm each) involving only epidermis on the volar aspect of the palm and forearm. Each of them will be closed with one stitch
15872988|NCT03858946|Procedure|Weilby|The first part of the surgical procedure is identical to simple trapeziectomy. In addition, the tendon sheath of the first extensor compartment is divided. After this, a strip consisting of approximately one-third of flexor carpi radialis tendon is dissected using two small incisions on the volar aspect of the wrist and distal forearm. The distally based tendon strip is tunneled to its insertion on the second metacarpal bone. Then the strip of tendon is winded around the abductor pollicis longus tendon and the rest of the tendon at least twice, pulling those tendons together into the space created after excision of the trapezium. The tendons are sutured together with non-absorbable sutures while the skin is sutured in the usual manner
15872993|NCT03858894|Drug|DE-117 Ophthalmic Solution QD|DE-117 ophthalmic solution QD and Vehicle (no active DE-117 ingredient) QD add one drop in each eye
15872994|NCT03858894|Drug|DE-117 Ophthalmic Solution BID|DE-117 ophthalmic solution BID twice Daily (20:00 and 8:00) add one drop in each eye
15872995|NCT03858881|Behavioral|PROJECT PERSONALITY|"PROJECT PERSONALITY is self-administered by youth via Qualtrics and is 30 minutes in duration. The intervention includes five elements: 1. An introduction to the brain, including a lesson on neuroplasticity (how and why our behaviors are controlled by thoughts and feelings in the brains, which have potential for change); 2. Testimonials from older youths who describe their views that people's traits are malleable, given the brain's plasticity; 3. Additional vignettes written by older youths, describing times when they used growth mindsets to persevere through social and emotional setbacks; 4. A summary of selected scientific studies suggesting that personality can, and often does, change in positive ways over time; and 5. An exercise in which the participants write notes to younger students, drawing on scientific information to describe the malleability of people's personal traits"
15872996|NCT03858881|Behavioral|VR PERSONALITY PROJECT|The VR PERSONALITY PROJECT contains similar elements as PROJECT PERSONALITY, including a lesson on neuroplasticity; testimonials from older youths; information about research on the malleability of personal traits; and an exercise wherein the participant provides advice to a student in the VR environment who has experienced a peer-related setback. Content is delivered by characters in the VR environment (hired/filmed actors) who guide youths through the program, providing scientific information and personal stories. Completion time is 30-40 minutes. The key difference between the VR and web-based mindset intervention is the delivery system, and by extension the level of immersion each program offers. The VR program is designed to be immersive, fun and interactive; youth choose to speak to various scientists and students within the VR environment and navigate themselves from scene to scene. In the online program, participants automatically view a series of text-based activities.
15872997|NCT03858881|Behavioral|SHARING FEELINGS PROGRAM|The web-based supportive therapy (ST) intervention, called the Sharing Feelings Program, is delivered via Qualtrics, self-administered by youth, and 30 minutes in duration. It aims to encourage youths to identify and express feelings to close others and does not teach specific skills or beliefs. It is designed to control for nonspecific aspects of intervention, including engagement in a technology-based program. It mirrors the web-based growth mindset intervention as closely as possible, including vignettes written by older youths who describe times when they benefited from sharing their feelings with friends or family.
15872998|NCT03858868|Behavioral|Church and park-based intervention|Multiple components involving motivational messages and concrete opportunities for physical activity at the church and the local park.
15872999|NCT03858868|Behavioral|Standard health education on physical activity|Participants will receive publicly available brochures, tip sheets, etc. about physical activity
15873000|NCT03858855|Procedure|Aromatherapy and Essential Oils|Use bergamot essential oil
15873001|NCT03858855|Procedure|Aromatherapy and Essential Oils|Use chamomile essential oil
15873002|NCT03858855|Procedure|Aromatherapy and Essential Oils|Use ginger essential oil
15873003|NCT03858855|Procedure|Aromatherapy and Essential Oils|Use almond essential oil
15873004|NCT03858855|Other|Subject Diary|Complete journal
15873005|NCT03858842|Other|epidemiology, healthcare costs in non-IPF PF-ILD and SSc-ILD|epidemiology, characteristics, healthcare resources and associated costs of patients diagnosed with non-IPF PF-ILD and SSc-ILD
15873006|NCT03858829|Other|Psychometric analysis|Psychometric analysis
15873007|NCT03858816|Other|Mixture probiotics|The mixture probiotics capsule
15873008|NCT03858816|Other|Placebo|The placebo contains the same excipient ingredients but without the live bacteria.
15873009|NCT03858803|Behavioral|Families Matter 2|Parents training in communication, youth sexual development, parental monitoring, parental use of positive reinforcement, risks facing adolescents and their management.
15873010|NCT03858803|Behavioral|Living as a Safer Teen|Prevention intervention for adolescents 13-18 that provides information, motivation, and behavioral skills to prevent STIs, HIV, and unplanned pregnancy.
15873011|NCT03858790|Device|PINS Spinal Cord Stimulator|Subjects will be implanted with PINS spinal cord stimulator
15873012|NCT03858777|Diagnostic Test|cell free DNA|All groups will have blood draws and cfDNA measured
15873013|NCT03858751|Drug|Placebo oral capsule|Placebo capsule before bedtime
15873014|NCT03858751|Drug|LTM1201AZ|LTM1201AZ oral capsule before sleep
15873015|NCT03858751|Drug|LTM1201AT|LTM1201AT oral capsule before sleep
15873016|NCT03858751|Drug|LTM1201AG|LTM1201AG oral capsule before sleep
15873017|NCT03858751|Drug|LTM1201AD|LTM1201AD oral capsule before sleep
15873018|NCT03858738|Device|Thermographic breast examination performed by Braster device|Patient undergo contact thermography examination with the use of liquid crystal contact thermography device- Braster.
15873019|NCT03858725|Drug|D569 Tab.|D569 Tab. 1T single oral administration under fasting condition
15873020|NCT03858725|Drug|CKD-374 5mg Tab.|CKD-374(Tofacitinib) 5mg Tab. 1T single oral administration under fasting condition
15873021|NCT03858712|Other|Active Care Team Alert|"2) Active care team alert via office practice nurse monitoring of ePRO oral responses scored at 3, indicating moderate-severe (grade ≥3) toxicity.
~Office practice nurses will monitor ePRO oral responses and respond to those scored at 3 per disease center symptom management protocol.
~The ePRO oral responses from the remaining participants will additionally be monitored by office practice nurses who will respond to ePRO responses with scores of 3, indicating a moderate-severe toxicity (grade 3 or higher)."
15873022|NCT03858712|Other|Passive Care Team Alert|"Primary care teams are assigned an EHR inBasket pool through which PP messages are delivered. Providers will be responsible for reviewing ePRO responses via inBasket, selecting mark as reviewed button as mandated for all clinical messages within 48 hours per policy."
15873023|NCT03858699|Other|Recording of electroencephalographic (EEG) data|Non-invasive brain activity will be measured with electroencephalography (EEG). EEG uses scalp sensors to monitor the brain's electrical activity. EEG sensors are placed on the scalp and passively record neural activity with high time resolution.
15873024|NCT03858686|Drug|FP-025 capsules|FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
15873256|NCT03856827|Drug|IW-6463|IW-6463 Tablet
15873257|NCT03856827|Drug|Matching Placebo|Matching Placebo Tablet
15873025|NCT03858686|Drug|Placebo FP-025 capsules|Placebo FP-025 capsules, BID will be administered to subjects in either Period 1 or Period 2, and given for 12 consecutive dosing days.
15873026|NCT03858673|Procedure|VTH via the Tsuzi method with residual uterine ligament ligation|VTH via the Tsuzi method with residual uterine ligament ligation
15873027|NCT03858660|Other|No intervention|No intervention
15873028|NCT03858634|Drug|KPL-716|solution for injection
15873029|NCT03858634|Drug|Placebo|solution for injection
15873030|NCT03858621|Drug|fentanyl NOL guided|Intervention is NOL monitoring in this group that will help to guide intravenous administration of fentanyl during surgery.
15873031|NCT03858608|Dietary Supplement|Counterweight Plus|Total diet replacement followed by food reintroduction and weight maintenance.
15873032|NCT03858608|Other|Usual asthma care|Usual asthma management
15873033|NCT03858595|Device|Self monitoring of blood pressure using Health Gauge Device and monthly monitoring of weight gain|"Women in the intervention arm will be provided with the Health Gauge device. With this device, the women will be able to do self-monitoring of blood pressure as well as a few other things like heart rate, daily activities. We will also measure weight gain of the mothers at monthly basis."
15873034|NCT03858582|Drug|pembrolizumab|pembrolizumab 200mg
15873035|NCT03858582|Radiation|Radiation|52.8Gy/24Fx or 59.4Gy/27Fx
15873036|NCT03858569|Procedure|active management of third stage of labor|Active management of the third stage of the labor will be done administering oxytocin and cord traction.
15873037|NCT03858556|Procedure|Chuna manipulation|Chuna is a Korean spinal manipulation that incorporates spinal manipulation techniques for joint mobilization involving high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement. Chuna manipulation will be administered to pelvic, lumbar, thoracic, and cervical vertebrae at the physician's discretion.
15873038|NCT03858556|Drug|Herbal medicine|Herbal medicine will be administered in water-based decoction (120ml) and dried powder (2g) form (Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, Saposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycine max, Atractylodes japonica).
15873039|NCT03858556|Procedure|Bee venom pharmacopuncture|Bee venom pharmacopuncture will be administered only after confirming a negative response to hypersensitivity skin test. Diluted bee venom (saline:bee venom ratio, 10,000:1) filtered for allergens will be injected at 4-5 acupoints proximal to the dysfunctional site at the physician's discretion. Each acupuncture point will be injected to a total of 0.5-1 cc using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
15873040|NCT03858556|Procedure|Pharmacopuncture|Pharmacopuncture consisting of select herbal ingredients will be administered at Hyeopcheok (Huatuo Jiaji, EX B2), Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
15873041|NCT03858556|Procedure|Acupuncture|Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
15873042|NCT03858556|Procedure|Electroacupuncture|Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
15873043|NCT03858556|Procedure|Cupping|Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.
15873044|NCT03858556|Other|Other intervention(s)|Patients will be allowed any other additional intervention(s) as deemed necessary by the attending physician regardless of type or dose, and patterns of use will be investigated and recorded as an pragmatic clinical study.
15873045|NCT03858543|Drug|Poly-L Lactic Acid|After initial treatment, reassessment will be conducted at 3 follow-up visits. Photographs will be taken for blinded evaluators to compare post-treatment to the original pre-treatment photographs. At final visit, a questionnaire will be administered to rate treatment satisfaction.
15873046|NCT03858543|Device|Fractional laser treatment|After initial treatment, reassessment will be conducted at 3 follow-up visits. Photographs will be taken for blinded evaluators to compare post-treatment to the original pre-treatment photographs. At final visit, a questionnaire will be administered to rate treatment satisfaction.
15873047|NCT03858530|Diagnostic Test|Ultrasound Examination|Grayscale ultrasound, Doppler ultrasound, ultrasound elastography with or without ultrasound intravenous contrast will be performed.
15873048|NCT03858517|Device|ReUnion TSA System|The ReUnion TSA System is designed as an anatomical total shoulder or hemi-shoulder endoprosthesis to address advanced arthritic disorders affecting the shoulder joint in subjects having intact or repairable rotator cuff function. The ReUnion TSA System consists of a completely modular shoulder platform including a Humeral Stem, Humeral Head and Glenoid. The intended purposes of the ReUnion TSA System are to achieve pain relief, improvement of range of motion and restoration or improvement of the shoulder function while ensuring long-term replacement of the shoulder joint with sufficient stability of all endoprosthesis components.
15873049|NCT03858504|Other|Exercise|The children with enthesitis related arthritis will be randomized into one of the exercise groups as yoga or home exercises and will perform the exercise program for 2 times a week for 8 weeks according to their groups.
15873050|NCT03858491|Drug|Cobicistat|Cobicistat will be added to the treatment with osimertinib. The initial dose will be 150 mg cobicistat, which equals the dose used in the treatment of HIV-infected patients. If this dose is well tolerated and the increase in exposure of osimertinib is not sufficient, the dose of cobicistat will gradually be escalated to 600 mg per day (150 mg cobicistat, four times per day).
15873051|NCT03858478|Drug|Biktarvy arm|BIKTARVY : one tablet QD, every day between D0 and M12 includind - TAF (25mg) / FTC (200mg) / BICTEGRAVIR (50mg)
15873052|NCT03858465|Drug|Ephedrine|intravenous 25 mg of ephedrine
15873053|NCT03858465|Drug|Phenylephrine|intravenous 0,3 mg of phenylephrine
15873054|NCT03858452|Procedure|Muscles exercises program|
15873055|NCT03858439|Other|Dietary|Low sodium, low protein dietary recommendation
15873056|NCT03858426|Other|no intervention|no intervention
15873057|NCT03858413|Diagnostic Test|No intervention|No intervention
15873058|NCT03858387|Drug|Meropenem|"This group is composed of 52 critically ill patients, meropenem dosage is chosen by the intensivist in charge of the case.
~Blood sampling: 5 blood samples (3 mL) were obtained from a heparinized intravascular catheter by direct venipuncture at the following time: before (time 0) and during 0-0.5 h, 0.5-2.5 h, 2.5-4 h, 4-8 h or 4-12 after meropenem administration."
15873059|NCT03858387|Drug|Imipenem|"This group is composed of 50 critically ill patients, imipenem dosage is chosen by the intensivist in charge of the case.
~Blood sampling: 5 blood samples (3 mL) were obtained from a heparinized intravascular catheter by direct venipuncture at the following time: before (time 0) and during 0-0.5 h, 0.5-2 h, 2-4 h, 4-6 h or 4-12 after imipenem administration."
15873060|NCT03858374|Device|transferred by air-suspending mattress|Put mattress in advance on the bed. When patients need to be transferred from bed to bed, fill the mattress with gas and keep it inflated, then pull the mattress .
15873061|NCT03858374|Device|transferred by slide board|When patients need to be transferred from bed to bed, insert slide board under patient, then pull the slide board.
15873062|NCT03858374|Device|transferred by bedsheet|When patients need to be transferred from bed to bed, just lift the bedsheet.
15873063|NCT03858361|Device|Atrial Flutter Ablation|Catheter-based electrophysiological (EP) intervention.
15873064|NCT03858335|Other|Constraint-induced movement therapy|The constraint-induced movement therapy (CIMT) program requires children to wear forearm splint on the unaffected arm 24 hours for 3 weeks. The program consists of 5 sessions per week for 3 weeks.
15873065|NCT03858322|Drug|Paclitaxel|The drug work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die.
15873066|NCT03858322|Drug|Cyclophosphamide|The drug work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die.
15873067|NCT03858322|Drug|Carboplatin|The drug work by damaging the RNA or DNA that tells the cell how to copy itself in division. If the cells are unable to divide, they die.
15873068|NCT03858309|Behavioral|Breathing Group 1|The 8-week breathwork intervention incorporates a set of breathing practices under the guidance of a certified yoga teacher.
15873069|NCT03858309|Behavioral|Breathing Group 2|The 8-week breathwork intervention incorporates a set of slow breathing practices under the guidance of a certified yoga teacher.
15873070|NCT03858296|Behavioral|Internet-delivered emotional awareness training|Emotional awareness training is delivered via an internet platform during 4 weeks and includes therapist contact several times per week via the platform.
15873071|NCT03858296|Behavioral|Internet-delivered Cognitive reappraisal training|Cognitive reappraisal training is delivered via an internet platform during 4 weeks and includes therapist contact several times per week via the platform.
15873072|NCT03858296|Behavioral|Internet-delivered awareness and reappraisal training|Emotional awareness and cognitive reappraisal training is delivered via an internet platform during 4 weeks and includes therapist contact several times per week via the platform.
15873073|NCT03858283|Behavioral|Mindfulness Based Health Care (MBHC) Program|Mindfulness Based Health Care (MBHC) Program for Caregivers of Alzheimer's Disease Patients. The duration of this group was 8 weeks. The program included one session per week, with each session lasting 1 hour and 30 minutes
15873074|NCT03858270|Drug|Memantine|Memantine will be started at 10 mg tablet once/day for a week at bedtime. After one week Memantine will be administered at 10 mg tablet twice/day for 51 weeks.
15873075|NCT03858270|Other|Placebo|Placebo will be started at 10 mg tablet once/day for a week at bedtime. After one week Placebo will be administered at 10 mg tablet twice/day for 51 weeks.
15873076|NCT03858257|Device|High flow nasal oxygen|The Optiflow device (Fisher and Paykel Healthcare, Auckland, New Zealand) will be used.
15873077|NCT03858257|Device|Standard oxygenation|Supplemental oxygen through a facemask.
15873078|NCT03858231|Drug|Norco 5Mg-325Mg Tablet|1 tablet up to 4 times per day for 7 days
15873079|NCT03858231|Drug|Ibuprofen 600 mg|1 tablet up to 4 times per day for 7 days
15873080|NCT03858231|Drug|Acetaminophen 325Mg Tab|1 tablet up to 4 times per day for 7 days
15873081|NCT03858218|Other|questionnaires set|questionnaires set: The Chinese version of the Pittsburgh Sleep Quality Index (PSQI)+The Chinese version of the Center for Epidemiologic Studies Depression Scale for Children (CES-DC)+ The Chinese version of the Pediatric Quality of Life Inventory 4.0 Generic Core Scale (PedsQL 4.0)
15873085|NCT03858192|Procedure|Colorectal surgery procedure|Elective admission for colorectal surgery
15873086|NCT03858192|Procedure|Emergency abdominal surgery|Emergency admission necessitating emergency surgery
15873087|NCT03858192|Drug|Antibiotics|Treatment for infection and reason for admission
15873088|NCT03858179|Device|PBMT|PBMT will be applied bilaterally using the direct contact method with light pressure on the skin to 6 sites of the anterior thigh (2 medial, 2 lateral, and 2 central). A 12-diode cluster, with 4 905-nm laser diodes (12.5W peak power for each diode), 4 875-nm LED diodes (17.5 mW mean power for each diode), and 4 640-nm LED diodes (15 mW mean power for each diode), manufactured by Multi Radiance Medical® (Solon, OH, USA), will be used to apply the PBMT. The dose used for applications during the training and/or detraining periods will be 30 Joules (J) per site (180 J per thigh). PBMT will be applied before each workout and during the detraining period, depending on the group to which the volunteers are allocated.
15873089|NCT03858179|Device|Placebo|Placebo PBMT will be applied bilaterally using the direct contact method with light pressure on the skin to 6 sites of the anterior thigh (2 medial, 2 lateral, and 2 central). The placebo PBMT will per performed using the dose of 0 J per diode. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (active or placebo). Placebo PBMT will be applied before each workout and during the detraining period, depending on the group to which the volunteers are allocated.
15873090|NCT03858166|Drug|PEG-rhG-CSF|6mg PEG-rhG-CSF was administrated subcutaneously at different time after chemotherapy.
15873091|NCT03858153|Behavioral|EXCAP Exercise|12 weeks of at-home walking and resistance exercise.
15873092|NCT03858153|Behavioral|Nutrition Education|12 weeks of implementing eating tips and tracking food.
15873093|NCT03858127|Other|Collection of urine sample|Collection of urine sample for measurement of LH and FSH
15873094|NCT03858127|Other|Examination of genitalia|Examination of genitalia
15873095|NCT03858127|Other|Video messaging|Short video of infant recorded at home by the parents
15873556|NCT03854539|Other|Transdermal Vagus Nerve Stimulation|intermittent transdermal stimulation of the aurical vagus
15873096|NCT03858114|Other|Mild-to-moderate physical activity|"According to ACSM guidelines, mild-to-moderate Physical Activity (PA) will be established as ≤ 60% of the Heart Rate Reserve (HRR). Baseline HR will be registered for all participants for three days, and the mean data will be utilized. PA intervention will consist of three phases:
~warm up (10 minutes), up to 40% of HRR, with slow, dynamic movements and stretching for principal muscular groups;
~Active phase (45 minutes), from >40% to 60% HRR, with static and dynamic exercises for postural control and spine mobility, and balance exercises, with activation of core muscles;
~cool down (10 minutes), < 40% of HRR, with cardiorespiratory cool-down exercises followed by relaxation, and post-stretch exercises to return muscles to a pre-exercises length."
15873097|NCT03858114|Other|Cultural group program|A cultural group program with 12-weeks thematic meetings on places of historical and artistic interest in the city of Cagliari, Sardinia, with one visit/week to the same sites. The participants will be accompanied by expert tour guides to museums, monuments, city parks and archeological sites.
15873098|NCT03858088|Procedure|Liver transplantation|Liver transplantation from deceased donors
15873099|NCT03858075|Drug|BLU-782|oral capsules
15873100|NCT03858075|Drug|Placebo|oral capsules
15873101|NCT03858075|Drug|BLU-782 taken with food|oral capsules
15873102|NCT03858062|Device|Insulin pump therapy (with or without glucose sensor)|Patients' own insulin pump with fast-acting insulin analog and optionally with own glucose sensor
15873103|NCT03858062|Device|Artificial pancreas (Inreda Diabetic)|Bi-hormonal reactive closed loop system without mealtime announcement
15873104|NCT03858049|Drug|Crinone|Participants will receive 90 milligram (mg) of intravaginal Crinone gel daily in the morning in the treatment period for approximately 75 days.
15873105|NCT03858049|Drug|Duphaston|Participants will receive 10 mg of Duphaston orally twice a day in the treatment period for approximately 70 days.
15873106|NCT03858036|Drug|Ricrolin+|1 to 2 drops of Ricrolin+ will be instilled topically in the eye every 2 minutes for 30 minutes. At the end of the Ricrolin+ pre-treatment period, the eye will be examined at the slit lamp to detect the presence of a yellow flare in the anterior chamber, indicating adequate riboflavin saturation of the corneal tissue. If the yellow flare is not detected, Ricrolin+ will continue to be instilled 1 drop every 2 minutes for an additional 5 to 10 minutes; and the anterior chamber will be rechecked for yellow flare. This process will be repeated as necessary. During the irradiation period, 1 to 2 drops of Ricrolin+ to cover the cornea (in the same manner as during the riboflavin pre-treatment) before the start of irradiation and every 5 minutes during irradiation until irradiation is complete.
15873107|NCT03858036|Device|VEGA UV-A system|The VEGA light will be administered for 30 minutes. The VEGA light will stop automatically every 5 minutes for Ricrolin+ administration.
15873108|NCT03858023|Other|Hippotherapy|The hippotherapy program consists of 2 sessions per week for 15 weeks. One session is 30-minute session. The program involves 2 therapists and 3 personnel for safety issues.
15873109|NCT03858010|Diagnostic Test|Wheeze and me questionnaire|validation of questionnaire assessing disease control and quality of life in preschool children with recurrent wheeze
15873110|NCT03857997|Biological|Patient blood sampling|sequencing by WGS and RNA-seq
15873111|NCT03857997|Biological|Parents blood sampling|sequencing by WGS
15873112|NCT03857984|Other|Blood sampling|blood sample before and after a single HD
15873113|NCT03857971|Device|Coronary Optical Coherence tomography|Optical coherence tomography imaging is performed of non-obstructive, non-culprit coronary lesions to assess plaque morphology.
15873114|NCT03857958|Procedure|endoscopic retrograde cholangio-pancreatography|In patients who were identified to have malignant hilar biliary obstruction, bilateral stents insertion is attempted via ERCP. There will be two groups divided by stent material; FCSEMS and Plastic stent.
15873115|NCT03857945|Other|Preoperative mobility device(s) training|Patients in Group 1 (the intervention, that is the mobility device training group group) will receive training on the mobility device(s) with the physical therapy visit during their standard pre-operative care.
15873116|NCT03857932|Procedure|Participants receive SLNB as well as non SLNs resection|Participants only receive SLNB preoperative CT lymphography SLNB with stained non-SLN resection SLNB with ARM dissection
15873117|NCT03857919|Device|TearCare|The TearCare SmartLids will be applied to the external surface of each eyelid. The TearCare System will be turned on and heat will be delivered to the eyelids for 15 minutes. Immediately following the thermal portion of the procedure, the SmartLids will be removed and the doctor will manually express the meibomian glands.
15873118|NCT03857919|Device|LipiFlow|The LipiFlow activators will be placed between the inner eyelid and the corneal surface of each eye. The LipiFlow System will be turned on and heat and pressure will be delivered to each eyelid for 12 minutes.
15873119|NCT03857906|Device|Intra-Aortic Ballon Pump insertion|The IABP (Ultraflex IAB 7.5F, 2.5mm; Arrow International, Reading, PA) was inserted percutaneously through the right femoral artery in the previous 1 - 6 hours before the scheduled surgery. Positioning of the IABP was guided by radioscopy. The balloon size was based on the patient's height (30, 40 or 50 cc). Transesophageal echocardiography was used to confirm correct IABP placement before and after CABG
15873120|NCT03857893|Device|Dynamic Quadripolar Radio-Frequency treatment|"Novel low-energy Dynamic Quadripolar Radio-frequency thermal treatment through Eva™ Device. Eva™ Device combines both advanced VDR™ technology (Vaginal Dynamic Radiofrequency) and RSS™ (Radiofrequency Safely System) technology."
15873121|NCT03857893|Drug|pH-Cream|1g of Cetomacrogol cream (pH-cream) to self-administered with a vaginal applicator for 12 weeks (one dose every three days)
15873122|NCT03857867|Device|Tactile Stimulation Glove|A glove device produces non-painful sensory (tactile) vibratory stimulation to the fingertips of Parkinson's patients.
15873123|NCT03857867|Device|Sham Stimulation Glove|Sham Device to mimic tactile stimulation glove.
15873124|NCT03857854|Drug|Pirfenidone|treatment group
15873125|NCT03857854|Drug|Placebos|placebo group
15873126|NCT03857841|Biological|UNEX-42|UNEX-42 is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells suspended in phosphate-buffered saline.
15873127|NCT03857841|Biological|Phosphate-buffered saline|Phosphate-buffered saline
15873128|NCT03857828|Other|semen sample|• seminal sample for measuring clusterin level.
15873614|NCT03854071|Other|intravenous fluid challenge|Patients will undergo a receive a pre-load increasing stress test with intravenous fluids depending on tolerability
15873129|NCT03857815|Radiation|anti-PD-1 antibody|"In patients with inoperable hepatocellular carcinoma or recurrence after local or regional therapy, stereotactic body radiation therapy will be combined with anti-PD-1 antibody.
~Stereotactic body radiation therapy: SBRT is delivered to 1~5 Evaluable lesions of liver, lung, bone, brain or lymph nodes in limited fractions .
~Anti-PD-1 treatment: anti-PD-1 antibody (IBI308) is injected intravenously 200mg every three weeks."
15873130|NCT03857802|Behavioral|Sleep hygiene intervention|"An individual education will be carried out following a bidirectional feedback method. It is intended to develop skills to make conscious and autonomous decisions. The explanation will consist:
~Information and reading with discussion of the educational sheet: The 9 tips for a healthy sleep will be read, point by point. The nurse will be open to discuss those that generate doubt.
~Confrontation: even if the patient does not ask any questions about it, it will be necessary to ask if he has understood the advice.
~Participated information: Questions will be asked to the patient such as: Did you already know any of these tips?.
~A telephone call per month will be made as an educational reinforcement to the intervention."
15873131|NCT03857789|Other|Questionnaire|A 40 question frailty questionnaire.
15873132|NCT03857776|Other|Open dialogue about complementary alternative medicine|1-hour dialogue about CAM with a nurse specialist as an Integrated part of conventional oncology care
15873133|NCT03857776|Other|Standard care|Standard care including referral to a homepage about CAM
15873134|NCT03857763|Combination Product|Apatinib,Paclitaxel,Cisplatin,RT|Apatinib Mesylate Tablets 250mg qd p.o. d1-35; Paclitaxel：50mg/m2 iv d1，8，15，22，29; Cisplatin: 30mg/m2 iv d1，8，15，22，29; RT：41.4Gy/23f , 1.8Gy/f，5 f/w
15873135|NCT03857750|Drug|Rocuronium|0.6 mg/kg
15873136|NCT03857737|Procedure|endoscopic submucosal dissection|Endoscopic submucosal dissection is an endoscopic procedure which can achieve en bloc resection of GI tumor. ESD is characterized by three steps: injecting fluid into the submucosa to elevate the lesion from the muscle layer, circumferential cutting of the surrounding mucosa of the lesion, and subsequent dissection of the connective tissue of the submucosa beneath the lesion. The ESD procedure will be carried out by experienced endoscopists.
15873137|NCT03857737|Procedure|Surgery|Surgery for EGC include Distal, proximal, or total gastrectomy, which will be performed according to the location and macroscopic tumor type by experienced surgeons.
15873138|NCT03857724|Procedure|prolapse surgery|prolapse surgery
15873139|NCT03857711|Procedure|Conventional CABG|Coronary artery bypass grafting
15873140|NCT03857711|Procedure|CABG+ PVI|CABG+ prophylactic epicardial bipolar radiofrequency isolation of the pulmonary veins
15873141|NCT03857711|Procedure|CABG+ PVI+amiodarone|CABG+PVI+amiodarone (CABG+RFA + class III antiarrhythmic drug- amiodarone)
15873142|NCT03857711|Procedure|CABG+amiodarone|
15873143|NCT03857698|Other|Conservative Physical Therapy|"Patients who were discharged from the hospital and received the sutures will be supervised 2 days a week for 8 weeks. Exercise programs will be promoted individually.
~Ice application for pain, edema control
~Patellar mobilization
~Three-way straight leg lifting exercises
~Isometric exercises around the hips and knees
~Active assisted, active, resistant knee range of motion exercises
~Heel shift exercises in supine and sitting
~Hip abduction on the side lying
~Stretching exercises for patients with gastrosoleus, hamstring, hip flexor muscles
~Neuromuscular Electrical Stimulation (NMES) for quadriceps muscle of patients will be applied. The isometric quadriceps contraction observed during the procedure will be required to actively participate in the patients."
15873144|NCT03857698|Other|Body Stabilization Exercise|"In the first session, breathing control and alet abdominal hallawing of movement will be taught to the patients with the help of the pressure biofeedback device. The degree of difficulty of the exercises will be improved by using different positions, by adding rotations to the motion, making the pelvic control more difficult and increasing the number of repetitions. In case of exacerbation of symptoms, the level will not be advanced. Exercises will be advanced according to the patient's initial level and response to exercise.
~Consecutive shoulder flexion and extension in supine
~Building a bridge
~Lower body and hip flip
~Single leg extension with bilateral arm elevation
~Resilient leg stretch with bilateral arm elevation
~Hip external rotation in lateral hospitalization
~Side-lying arm opening
~Shoulder girdle retraction on ball, horizantal abduction and extension"
15873145|NCT03857685|Procedure|In-vitro model|In-vitro model of posterior capsule opacification by culturing the lens capsule
15873146|NCT03857672|Behavioral|Hypnotic Cognitive Therapy (HYPNOCT)|The HYPNOCT intervention will use hypnotic strategies and suggestions for identifying adaptive cognitions and for making adaptive changes in cognitions more integrated into the participant's belief system (note that traditional CT uses purposeful argument and logic to make these changes; in this condition the investigators add a hypnotic automaticity to this process). Thus, HYPNOCT is a hybrid intervention (more than the sum of CT and hypnosis) that overlaps with both hypnosis and CT. The participant will relax in a comfortable position and listen to the clinician speak. However, unlike standard hypnosis for pain, the post-induction suggestions will focus on changes in cognitive content and processes (as opposed to changes in sensory experience).
15873147|NCT03857659|Diagnostic Test|Point-of-care ultrasound (POC-US)|POC-US evaluation will be conducted using the portable ultrasound machine, which is capable of straight-line measurements for assessment of the amniotic fluid, as well as ellipse measurements for determination of abdominal circumference. POC-US evaluation will be conducted every 4 weeks from 28-36 weeks.
15873148|NCT03857659|Diagnostic Test|Routine antenatal care|Routine care with fundal height measurement at each antenatal appointment every 2 weeks from 28-36 weeks. As well as clinically indicated obstetric ultrasound by a Registered Diagnostic Medical Sonographer (RDMS)
15873149|NCT03857659|Diagnostic Test|Formal ultrasound|Formal growth ultrasound performed between 36-38.6 weeks by RDMS.
15873150|NCT03857646|Drug|Intralipid, 20% Intravenous Emulsion|Lipids start at 1 g/kg/day and advance by 1 g/kg/day to a maximum of 3 g/kg/day as tolerated by the the neonate.
15873151|NCT03857646|Drug|SMOF lipid|Lipids start at 1 g/kg/day and advance by 1 g/kg/day to a maximum of 3 g/kg/day as tolerated by the the neonate.
15873152|NCT03857633|Diagnostic Test|Cardiac MRI 1 - With Gadolinium Contrast|"Cines for cardiac function and volumes, T2 myomaps, Resting perfusion and strain analysis, Tagging (strain), T1 myomaps, Late gadolinium enhancement
~During the MRI scan participants would be required perform a short period of low intensity exercise involving peddling on an adapted cycle for 10-15 minutes to provide additional data on cardiac function under exertion."
15888385|NCT03740165|Drug|Paclitaxel|IV infusion
15873153|NCT03857633|Diagnostic Test|Cardiac MRI 2 - With Gadolinium Contrast|"Cines for cardiac function and volumes, T2 myomaps, Resting perfusion and strain analysis, Tagging (strain), T1 myomaps, Late gadolinium enhancement
~During the MRI scan participants would be required perform a short period of low intensity exercise involving peddling on an adapted cycle for 10-15 minutes to provide additional data on cardiac function under exertion."
15873154|NCT03857633|Diagnostic Test|Cardiac MRI 3 - Without Gadolinium Contrast|"Cines for cardiac function and volumes, T2 myomaps, Resting perfusion and strain analysis, Tagging (strain), T1 myomaps.
~During the MRI scan participants would be required perform a short period of low intensity exercise involving peddling on an adapted cycle for 10-15 minutes to provide additional data on cardiac function under exertion."
15873155|NCT03857633|Diagnostic Test|Cardiac MRI 3 - With Gadolinium Contrast|"Cines for cardiac function and volumes, T2 myomaps, Resting perfusion and strain analysis, Tagging (strain), T1 myomaps, Late gadolinium enhancement
~During the MRI scan participants would be required perform a short period of low intensity exercise involving peddling on an adapted cycle for 10-15 minutes to provide additional data on cardiac function under exertion."
15873156|NCT03857633|Diagnostic Test|Peripheral Whole Blood Samples|20ml EDTA whole blood samples - collected sequentially during study - max 8 time points
15873157|NCT03857620|Other|Best Practice|Receive usual care
15873158|NCT03857620|Other|Informational Intervention|Receive OPTI-Surg program materials
15873159|NCT03857620|Other|Questionnaire Administration|Ancillary studies
15873160|NCT03857620|Other|Informational Intervention with Coaching|Receive OPTI-Surg program materials plus individual coaching
15873161|NCT03857607|Genetic|Whole exome sequencing|Whole exome sequencing will be used to identify causative genes in ATP1A3 mutation negative patients, to confirm causality in ambiguous phenotypes and to identify modifier genes.
15873162|NCT03857607|Diagnostic Test|Broadband Near Infrared Spectroscopy (broadband-NIRS)|A novel NIRS technology will be used to explore brain metabolism during paroxysmal events in ATP1A3-related disease
15873163|NCT03857607|Diagnostic Test|Transcranial Magnetic Stimulation (TMS)|TMS will be employed to explore motor cortex function in patients with ATP1A3-related disease.
15873164|NCT03857581|Drug|Clozapine|Subjects will be randomly assigned to clozapine or olanzapine and followed for up to 12 weeks with weekly visits.
15873165|NCT03857581|Drug|Olanzapine|Subjects will be randomly assigned to clozapine or olanzapine and followed for up to 12 weeks with weekly visits.
15873166|NCT03857568|Drug|SHR0410|drug will be dosed repeatedly
15873167|NCT03857568|Drug|Placebo|Placebo will be dosed repeatedly
15873168|NCT03857542|Drug|AGN-190584|Ophthalmic solution, one drop, dosed bilaterally, once daily for 30 days
15873169|NCT03857542|Other|Vehicle|Matching AGN-190584 ophthalmic solution dosed bilaterally, once daily for 30 days
15873170|NCT03857529|Device|transcranial direct current stimulation and electrical stimulator|"Contralaterally Controlled Functional Electrical Stimulation: An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator will be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES).
~Transcranial direct current stimulation (tDCS): TDCS is a method of noninvasive stimulation of the brain. Using electrodes placed in saline-soaked sponges, low level of direct current (1mA) is delivered over the scalp. This intervention is considered safe and noninvasive because it does not involve implantation or injection or any skin penetration."
15873171|NCT03857516|Device|Multipolar left ventricular lead implantation|Multipolar left ventricular lead implantation with measurements of pacing thresholds in varrious pacing configurations.
15873172|NCT03857503|Diagnostic Test|iFR|"Patients will undergo standard of care diagnostic coronary angiography using established invasive physiological criteria for iFR and FFR to aid in clinical decision making for coronary revascularization.
~Angiograms will be made in at least two projections, and the treating physician will record his/her estimation of stenosis severity.
~Resting iFR and Pd/Pa measures will then be made distal to the target lesion; adenosine will be administered, and the FFR measures will be made without moving the wire. An iFR pullback will then be made after hyperemia as abated. Patients will be treated or deferred from treatment based on physician decision aided by the iFR measures."
15873173|NCT03857490|Behavioral|Lower leg heat therapy|Home-based 8 weeks of lower leg repeated heating.
15873174|NCT03857477|Genetic|Genetic SNP profiling|Genetic SNP profiling of known prostate cancer predisposition SNPs will be performed on DNA extracted from saliva samples.
15873175|NCT03857477|Other|Prostate cancer screening|Prostate cancer screening in the form of PSA testing will be offered to all men who have a benign biopsy result for five years in order to track development of cancer in the future.
15873176|NCT03857477|Procedure|MRI Scan|MRI scan will be offered to men identified within the top 10% genetic risk score profile.
15873177|NCT03857477|Procedure|Prostate biopsy|Transperineal prostate biopsy under local anaesthetic will be offered to men identified within the top 10% genetic risk score profile.
15873178|NCT03857464|Diagnostic Test|Near Patient Testing|Near-patient testing will be conducted at Foothills Hospital rapid response lab. Negative results using C. DIFF QUIK CHEK COMPLETE® will be reported immediately to the patient wards. Positive results will be confirmed using nucleic acid testing at the centralized testing facility.
15873179|NCT03857464|Diagnostic Test|SOP for C. difficile diagnostics|Two-step testing algorithm for Clostridium difficile at centralized testing facilities. No change from the current protocol.
15873180|NCT03857451|Diagnostic Test|Clinical gait analysis|Three dimensional gait analysis consisting of joint kinematics, kinetics and dynamic EMG data will be introduced into the diagnostic scheme
15873181|NCT03857438|Drug|Ongoing treatment for bipolar mania|Prescribed by the following doctor during hospitalization and after discharge
15873182|NCT03857438|Diagnostic Test|Audiovisual recording during guided presentation|Seven tasks such as explaining the reason to come to hospital/participate in the activity, describing happy and sad memories, counting up to thirty, explaining two emotion eliciting pictures
15873183|NCT03857425|Drug|Clostridum Butyricum Capsule|Clostridum Butyricum Capsule 3*420mg,twice daily for 8 weeks
15873184|NCT03857425|Drug|Bacillus Coagulans Tablets|Bacillus Coagulans Tablets 3*350mg, three times daily for 8 weeks
15874312|NCT03848507|Drug|albumin 20%|Intravenous administration of 20% albumin during cystectomy
15873185|NCT03857425|Drug|Clostridum Butyricum Capsule plus Bacillus Coagulans Tablets|Clostridum Butyricum Capsule 3*420mg, twice daily for 8 weeks and Bacillus Coagulans Tablets 3*350mg, three times daily for 8 weeks
15873186|NCT03857412|Procedure|Capsular polishing|Capsular polishing taking place during cataract surgery
15873187|NCT03857412|Other|Non capsular polishing|No capsular polishing taking place during cataract surgery
15873188|NCT03857399|Drug|Caspofungin|Considering the possibility of fungal infection, we take empiric therapy for the patients with persistent fever and agranulocytosis using caspofungin for injection.
15873189|NCT03857386|Procedure|PECS group|Pecs block performed using ultrasound guidance
15873190|NCT03857386|Procedure|Control group|Local infiltration anesthesia performed during the operation
15873191|NCT03857360|Dietary Supplement|Pentabiocel|Pentabiocel is the trade name of the product containing the probiotic mixture of: Lactobacillus paracasei LMG P-17504, Lactobacillus plantarum CECT 4528, Bifidobacterium breve Bbr8 LMG P-17501, Bifidobacterium breve BL10 LMG P-17500 and Bifidobacterium animalis subsp lactis Bi1 LMG P -17,502.
15873192|NCT03857360|Dietary Supplement|Placebo|Placebo is composed of maltodextrin which is easily digestible, being absorbed as rapidly as glucose. Maltodextrin listed by the U.S. Food and Drug Administration (FDA) as a safe food additive.
15873193|NCT03857347|Other|Psychoeducation Group for FND|he intervention is a psychoeducation based group.
15873194|NCT03857334|Biological|Injection of autologous platelet rich plasma|
15873195|NCT03857334|Drug|Injection of cortivazol : Altim®|Corticosteroids
15873196|NCT03857321|Drug|Insulin|20 IU Humulin® R U-100 (NDC: 0002-8215, Eli Lilly & Company)
15873197|NCT03857321|Other|Placebo|Matching placebo (sterile saline) to 20 IU Humulin® R U-100
15873198|NCT03857321|Device|intranasal nebulizer-like device|Participants will be assigned to receive placebo or regular insulin (U100, 20 IU) administered through an intranasal nebulizer-like device.
15873199|NCT03857308|Behavioral|Mindfulness Training|"This stress reduction training will last 14 days and teach participants skills in concentration, monitoring of present-moment bodily experience, and acceptance of experience. Participants are encouraged to mentally welcome all physical and emotional experience. Each day will consist of approximately 25 to 30 minutes of training.
~A full explanation of the mindfulness training compared to the reappraisal training could interfere with study blinding procedures. A complete description can be provided after data collection is complete."
15873200|NCT03857308|Behavioral|Reappraisal Training|"This stress reduction training will last 14-days. Each day consists of 25 to 30 minutes of daily practice in Coping control. Participants are encouraged to reframe and reappraise life events, both past and present, and encouraged to solve personal problems through active change.
~A full explanation of the reappraisal stress reduction program compared to the mindfulness program could interfere with study blinding procedures. A complete description can be provided after data collection is complete."
15873201|NCT03857295|Other|No interventions|No intervention
15873202|NCT03857282|Other|Aerobic Exercises|5 to 10 min warm up exercises than 30min bicycle exercise and 5 to 10 min cool down exercises
15873203|NCT03857282|Other|Tai Chi Exercises|5 to 10 min warm up exercises and 30 min Tai Chi exercises and than than 5 to 10 min cool down exercises.
15873204|NCT03857269|Other|Acupoint Massage|The operators is trained for two weeks. At 9 o'clock in the morning, the elderly are organized by Nursing home to perform acupressure.Intervention frequency will be monday to saturday per week for 6 months.
15873205|NCT03857269|Other|lavender essential oil|Modulated by an international aroma therapist,The cotton ball containing essential oil is replaced by the operator at 9 am.Intervention frequency will be monday to saturday per week for 6 months.
15873206|NCT03857269|Other|Acupoint Massage and lavender essential oil|At the same time as the acupressure, patients began to smell the essential oil.Intervention frequency will be monday to saturday per week for 6 months.
15873209|NCT03857243|Device|dual transcranial direct current stimulation|Mild, non-invasive battery powered direct current applied to the head over the motor areas. No shaving or invasive procedures needed.
15873210|NCT03857230|Drug|Follitropin alfa (Primapur)|"During the crossover pharmacokinetic phase, after 42 days of combined oral contraceptive (ethinylestradiol and drospirenone) administration subjects with endogenous level of follicle stimulating hormone (FSH) less than 5 IU/l were randomly assigned to receive one of the following treatment sequences:
~Sequence A: Single subcutaneous injection of 300 IU Primapur on study day 1, after 10 days of wash out a single subcutaneous injection of 300 IU Gonal-F.
~Sequence B: Single subcutaneous injection of 300 IU US Gonal-F on study day 1, after 10 days of wash out a single subcutaneous injection of 300 IU Primapur."
15873211|NCT03857230|Drug|Follitropin alfa (Gonal-F)|"During the crossover pharmacokinetic phase, after 42 days of combined oral contraceptive (ethinylestradiol and drospirenone) administration subjects with endogenous level of follicle stimulating hormone (FSH) less than 5 IU/l were randomly assigned to receive one of the following treatment sequences:
~Sequence A: Single subcutaneous injection of 300 IU Primapur on study day 1, after 10 days of wash out a single subcutaneous injection of 300 IU Gonal-F.
~Sequence B: Single subcutaneous injection of 300 IU US Gonal-F on study day 1, after 10 days of wash out a single subcutaneous injection of 300 IU Primapur."
15873212|NCT03857217|Device|Extra-Corporeal Membrane Oxygenation|ECMO is implanted in cardiac surgery patients.
15873213|NCT03857204|Device|SAMPL plain wave algorithm|SAMPL's plain-wave algorithm allowing portable US or Wireless Probe scanning - thus enabling clinicians with more flexible point-of-care locations when performing US scans for fetal weight assessment.
15873214|NCT03857191|Dietary Supplement|Nutritional psychocomportemental rehabilitation|Nutritional psychocomportemental rehabilitation
15873215|NCT03857165|Drug|SAP-001|SAP-001 or placebo treatment in a 3:1 randomization ratio.
15873216|NCT03857152|Diagnostic Test|Contrast enhanced spectral mammography (CESM)|"Contrast enhanced spectral mammography (CESM) will be undertaken in addition to routine practice.
~CESM is a specialist mammography test that aims to 'highlight' areas of concern within the breast in more detail than a standard mammogram.
~The difference between CESM and a standard mammogram (x-ray of the breast) is the use of a special dye (called contrast medium) that is injected into the veins before the mammogram images are taken. The contrast enhanced images give more detailed information to the breast radiologists (expert doctors trained to analyse breast imaging)."
15873217|NCT03857139|Drug|Nicotine patch|Participants will receive the transdermal nicotine patch (TNP) to use during the first 2 weeks post-quit. We chose the TNP because of the extensive empirical literature supporting its effectiveness and safety, ease of use, and relatively benign side effect profile. Anxiety and depressive symptoms predict poor smoking cessation outcomes among individuals receiving NRT , suggesting that emotional disturbance influences relapse even in the context of NRT.
15873218|NCT03857126|Other|Signal acquisition|ECG-PCG-CTG synchronized signals acquisition over a monitoring phase of 30 minutes. These signals will be acquired with passive non invasive sensors (abdominal and thoracic).
15873219|NCT03857113|Procedure|PSMA-radioguided surgery|PSMA-radioguided surgery
15873220|NCT03857100|Other|Audit and feedback - letter and report|letter describing project and report of participants' outlier status and how participants compare to peers
15873224|NCT03857074|Device|Green Light Exposure|To test whether exposure to a narrow band of green light (520-540 nm) at low intensities (1-10 cd/m2) decreases interictal epileptiform discharges in patients with epilepsy. The overall hypothesis for this open-label trial is based on findings in patients with migraine that indicate an engagement of thalamocortical inhibitory circuits by green light.
15873225|NCT03857061|Device|smartphone, smartwatch, WearCOPDv2 application|"WearCOPD2 consists of hardware and software components.
~6.1 Hardware The hardware for wearCOPDv2 consists of three main components; (1) a smartwatch, (2) a phone, and (3) a server.
~6.2 Software
~The wearCOPDv2 system has two main software components:
~Data collection service
~Participant user interface"
15873226|NCT03857048|Other|Weight Loss|12-wk weight loss intervention using a meal replacement strategy (Health & Nutrition Technology, Carmel, CA), with an 8-10% weight loss goal
15873227|NCT03857048|Other|Exercise training|16-wk supervised endurance exercise training program
15873228|NCT03857048|Other|Overfeeding|3-day hypercaloric diet designed to overfeed by 40% above total daily energy requirements
15873229|NCT03857035|Other|Piezosurgery group|Piezosurgery technique will be examined about impacted third molar surgery.
15873230|NCT03857022|Device|Enhanced External Counterpulsa|The EECP therapy was given as a 1-hour session, once daily, for a total of 35 sessions. The daily urine amount, blood pressure, time for taper off positive inotropic agents, length of hospital stay, and will be monitored daily in the hospital stay. Patients will be followed-up if he or she can be released from hospital and the mortality, readmission for heart failure, and 6-minute walking distance will be checked at the end of 6th month. Plasma natriuretic peptide (BNP) or N-terminal pro-brain natriuretic peptide (NT-pro-BNP) levels will be checked at enrollment, day 35, and 6th month.
15873231|NCT03856996|Biological|Stable CH505TF gp120|Administered by IM injection in the deltoid of the non-dominant arm
15873232|NCT03856996|Biological|Transient CH505TF gp120|Administered by IM injection in the deltoid of the non-dominant arm
15873233|NCT03856996|Biological|Glucopyranosyl Lipid Adjuvant-Stable Emulsion (GLA-SE)|Admixed with Stable CH505TF gp120 or Transient CH505TF gp120 for IM injection in the deltoid of the non-dominant arm
15873234|NCT03856983|Other|Point light display|Experimental group who will do usual rehabilitation and visualization of point-light human actions
15873235|NCT03856970|Drug|Microgestin®|30 μg/1500 μg tablets for oral administration
15873236|NCT03856970|Drug|Levothyroxine|600 μg tablets for oral administration
15873237|NCT03856970|Drug|Glyburide|5 mg tablets for oral administration
15873238|NCT03856970|Drug|Digoxin|0.25 mg tablets for oral administration
15873239|NCT03856970|Drug|IW-3718|500-mg film-coated tablets for oral administration
15873240|NCT03856957|Device|Endocuff colonoscopy|Colonoscopy performed with Endocuff for mucosal inspection and interventions (eg. polypectomy).
15873241|NCT03856957|Device|control|colonoscopy without endocuff
15873242|NCT03856944|Device|ReSTOR Toric|ReSTOR Toric bilateral IOL implantation
15873243|NCT03856918|Procedure|PEEP 3 cm of water|PEEP of 3 cm of water will be applied during one-lung ventilation.
15873244|NCT03856918|Procedure|PEEP 6 cm of water|PEEP of 6 cm of water will be applied during one-lung ventilation.
15873245|NCT03856918|Procedure|PEEP 9 cm of water|PEEP of 9 cm of water will be applied during one-lung ventilation.
15873246|NCT03856905|Other|Physical therapy program|It will consist of gentle stretching exercises for spastic muscles, facilitation of muscle contraction for the anti-spastic muscles, proprioceptive training, balance and postural control exercises, neurodevelopmental techniques, and gait training.
15873247|NCT03856905|Device|Extracorporeal shock wave therapy|It is an electromagnetic coil lithotripter (Modulith SLK; Storz Medical AG, Tagerwillen, Switzerland) provided with in-line ultrasound, radiographic, and computerized aiming (Lithotrack system; Storz Medical AG). The energy applied will be 0.030 mJ/mm2. The frequency will be 5 Hz, with a pressure of 1.5 bars, burst mode.
15873248|NCT03856905|Device|Functional electrical stimulation|It is a highly advanced medical device that consists of a battery-operated, single-channel electrical stimulator, two electrodes, and electrode leads with a cuff holds the system in place. The stimulation parameters will include pulse frequency (16-33 pulses per second), pulse width (25-300 µs) to produce a desired movement as close to normal as possible at the ankle during gait.
15873249|NCT03856892|Other|Hatha yoga|Novice subjects engage in an intensive full yoga practice of hatha breath based practices and inner meditative techniques along with body-based asana. Intensive level uses breath, management of abdomen, inner focus in all practices.
15873250|NCT03856892|Other|Not-breath-based yoga practices|Subjects engage in a limited regular hatha yoga practice that is mainly body-based asana at a less intensive level without abdomen, breath or inner focus. Subjects have begun as novices six months prior to active intervention group and move at a simple pace through practice.
15873251|NCT03856879|Behavioral|Proactive E-consult|E-consult recommendations and orders will be developed by a panel of pulmonologists and will address a range of care elements for patients with COPD.
15873252|NCT03856866|Drug|Hydroxychloroquine|Hydroxychloroquine: 4mg/kg/day, divided bid.
15873253|NCT03856866|Drug|Placebo|Liquid suspension compounded to mimic the active hydroxycholoquine interventional agent.
15873254|NCT03856853|Drug|Pirfenidone|pirfenidone for SSc-ILD treatment
15873255|NCT03856853|Other|placebo|as control
15873258|NCT03856814|Device|ELVeS® Radial® 2ring slim fiber used for EndoVenous Laser Ablation|Device for endovenous laser ablation manufactured by Biolitec AG company (ELVeS system) - diode laser with a wavelength of 1470 nm
15873259|NCT03856801|Other|Exercise|Whole-body vibration training in hypoxia and normoxia condition
15873260|NCT03856788|Drug|Saline|40 mL sterile normal saline
15873261|NCT03856788|Drug|Bupivacaine|40 mL 0.25% bupivacaine
15873262|NCT03856775|Device|Quantitative EEG and Seizure detector|Paediatric intensive care unit nurses, residents or fellows will perform hourly review of a bedside graphical display of the previous hour's epoch of quantitative EEG for seizure patterns. One page of quantitative EEG data represents one hour of recording. The graphical display will include a seizure-detection marker, seizure probability indicator, bilateral rhythmicity spectrogram and bilateral amplitude integrated EEG.
15873263|NCT03856762|Dietary Supplement|traditional Jiangnan diet|traditional Jiangnan diet supplement from Monday to Friday for six months
15873264|NCT03856762|Dietary Supplement|Mediterranean diet|Mediterranean diet supplement from Monday to Friday for six months
15873265|NCT03856762|Dietary Supplement|Current Shanghai diet|current Shanghai diet supplement from Monday to Friday for six months
15873266|NCT03856749|Other|Remote wheelchair skills training|"Prior to the first training session, the trainer will be provided with the results from the assessment immediately preceding training to provide him/her time to individualize the training session. Trainer will provide self-study materials (the Caregiver Handbook and caregiver-training video-recording) and an explanation on how these materials should be used.
~The wheelchair user and caregiver will be trained together on wheelchair skills, using the principles of the Wheelchair Skills Training Program, as outlined in the Wheelchair Skills Program Manual using remote technology. Each training session will be with a trainer-to-dyad ratio of 1:1 1 dyad = 1 manual wheelchair user + his/her caregiver. Training will continue until the goals have been met and retained (for at least one subsequent session), using up to 4 training sessions that will each last up to 60 minutes at intervals a minimum of 3 days."
15873267|NCT03856736|Other|MIAT|Moderated aerobic exercise
15873268|NCT03856736|Other|Control|Weekly body relaxation and sham group
15873269|NCT03856723|Other|Renal Replacement Therapy|"Indications for RRT were defined as previously reported.
~Kidney Disease: Improving Global Outcomes (KDIGO) stage 2 ;
~severe sepsis, persistence of hypotension (for more than 6 h) despite preload optimization and use of vasopressors or catecholamines (norepinephrine or epinephrine >0.1 μg/kg/min),
~refractory fluid overload (worsening pulmonary edema, PaO2/FiO2 <300 mm Hg or fluid balance >10% of body weight),
~low probability of rapid renal recovery according to the judgment of the intensivists and nephrologists."
15873270|NCT03856710|Device|self-gripping mesh|The initial laparoscopic approach will be the same for both groups until the process of selection and placement of the mesh (ProGripTM self-gripping mesh versus standard 'lightweight' (large pore) polypropylene mesh fixed with SecurestrapTM) which would be decided by randomization by sealed envelope into one of the 2 intervention groups: Group 1 (Self-gripping Mesh), Group 2 (Stapled Mesh).
15873271|NCT03856710|Device|Stapled mesh|The initial laparoscopic approach will be the same for both groups until the process of selection and placement of the mesh (ProGripTM self-gripping mesh versus standard 'lightweight' (large pore) polypropylene mesh fixed with SecurestrapTM) which would be decided by randomization by sealed envelope into one of the 2 intervention groups: Group 1 (Self-gripping Mesh), Group 2 (Stapled Mesh).
15873272|NCT03856697|Drug|Abivertinib Maleate Capsules|patients receive the test drug (Abivertinib maleate Capsules) since the first day of cycle 1. One cycle is defined as 21 days. The patient shall take the study drugs twice a day. The first dose is 3 capsules, and the second dose is 3 capsules. The drugs should be administered with water before or after meals.
15873273|NCT03856697|Drug|Placebo Gefitinib Tablets|patients receive the test drug (Placebo Gefitinib Tablets) since the first day of cycle 1. One cycle is defined as 21 days. The patient shall take the study drugs twice a day. The first dose is 1 tablet. The drugs should be administered with water before or after meals.
15873274|NCT03856697|Drug|Gefitinib Tablets|patients receive the control drug (Gefitinib Tablets) since the first day of cycle 1. One cycle is defined as 21 days. The patient shall take the study drugs twice a day. The first dose is 1 tablet. The drugs should be administered with water before or after meals.
15873275|NCT03856697|Drug|Placebo Abivertinib Maleate Capsules|patients receive the control drug (Placebo Abivertinib Maleate Capsules) since the first day of cycle 1. One cycle is defined as 21 days. The patient shall take the study drugs twice a day. The first dose is 3 capsules, and the second dose is 3 capsules. The drugs should be administered with water before or after meals.
15873294|NCT03856580|Behavioral|Alternative long-acting PrEP injection strategies|"Participants in the two intervention groups will complete injection procedures (e.g., self-injection, injection by healthcare providers at drop-in clinics) to determine if this could facilitate improved adherence to an inert version of long-acting cabotegravir injections"
15873615|NCT03854058|Diagnostic Test|magnetic phrenic nerve stimulation|cervical and cortical stimulation of N. Vagus
15873280|NCT03856671|Drug|Neomycin,metronidazole|Orally intake neomycin 1g and metronidazole 0.2g four times before surgery
15873281|NCT03856658|Drug|Floxuridine (FUDR)|Together the FUDR and the HAI pump are experimental because they are being used to treat hepatic liver metastases of Pancreatic adenocarcinoma. They have not yet been FDA approved for this indication, although they are both approved for other indications. The intervention is surgical placement of an HAI pump with subsequent delivery of FUDR via the pump in 28-day cycles. FUDR will be delivered via the HAI pump for 6 months, in 28 day cycles: 2 weeks of therapy, followed by 2 weeks of heparinized saline.
15873282|NCT03856658|Device|Hepatic Artery Infusion Pump|Together the FUDR and the HAI pump are experimental because they are being used to treat hepatic liver metastases of Pancreatic adenocarcinoma. They have not yet been FDA approved for this indication, although they are both approved for other indications. The intervention is surgical placement of an HAI pump with subsequent delivery of FUDR via the pump in 28-day cycles. The primary tumor will be resected or ablated with irreversible electroporation at the time of HAI pump placement. FUDR will be delivered via the HAI pump for 6 months, in 28 day cycles: 2 weeks of therapy, followed by 2 weeks of heparinized saline.
15873283|NCT03856658|Drug|Heparinized Saline|Together the FUDR and the HAI pump are experimental because they are being used to treat hepatic liver metastases of Pancreatic adenocarcinoma. They have not yet been FDA approved for this indication, although they are both approved for other indications. FUDR will be delivered via the HAI pump for 6 months, in 28 day cycles: 2 weeks of therapy, followed by 2 weeks of heparinized saline.
15873284|NCT03856645|Drug|OKG-0301|OKG-0301 is an experimental ophthalmic antiviral and immunomodulatory therapeutic
15873285|NCT03856632|Drug|Liraglutide|Liraglutide will be administered with a starting dose of 0.6 mg once daily and subsequent increments to 1.2 mg once daily (after at least one week) and to 1.8 mg once daily (after at least a week on 1.2 mg). This will be taken for 3 consecutive months in conjunction with RFM program prior to catheter ablation. Treatment will resume post ablation and will be continue for 6 months.
15873286|NCT03856632|Other|RFM|The program involves weight management and exercise regimen (30 minutes for 2 to 4 times a week), hyperlipidemia management (lifestyle measure changes and initiation of statins and fibrates if necessary), management of obstructive sleep apnea (initiation of Continuous Positive Airway Pressure (CPAP) if necessary), management of hypertension (reduction of salt intake, initiation of Angiotensin Converting Enzyme Inhibitor (ACEI) or Angiotensin II Receptor blockers (ARB) medications if necessary), diabetes management (lifestyle measure changes, endocrine review and initiation of metformin if necessary) and smoking cessation and alcohol abstinence or reduction. This program will be performed at start of study participation all throughout the follow up period.
15873287|NCT03856632|Drug|Anti Arrhythmics|The choice of antiarrhythmic drug will be at the discretion of the managing physician, but will generally include either a class IC or class III antiarrhythmic drug. If necessary, and clinically indicated, amiodarone may be used. Therapy will be initiated at the start of study participation and will be discontinued 6-12 weeks after the ablation, as deemed clinically appropriate by the managing electrophysiologist.
15873288|NCT03856632|Procedure|Afib Catheter Ablation|The procedure will be performed according to usual clinical practice. The primary approach will be antral pulmonary vein isolation (PVI), preferably performed by cryoballoon ablation, though radiofrequency may be used as deemed necessary by the operator for clinical reasons. This will be performed after 3 months of RFM or RFM + Liraglutide program.
15873290|NCT03856606|Behavioral|Prolonged sitting without exercise|Subjects will have a 2-day control period during which step count and diet will be controlled for and recreated for the other trial. Following this 2-day period, they will undergo the prolonged sitting trial. Day 4 will consist of the lipid tolerance test to determine the ability of the body to clear triglycerides.
15873291|NCT03856606|Behavioral|Prolonged sitting with interval exercise|Subjects will have a 2-day control period during which step count and diet will be controlled for and recreated for the other trial. Following this 2-day period, they will undergo a prolonged sit which with will be broken up every hour on the hour by a small bout of interval exercise. Day 4 will consist of the lipid tolerance test to determine the ability of the body to clear triglycerides.
15873292|NCT03856593|Behavioral|Letter A|The letter will be signed by the Chief Medical Examiner-Coroner and County Health Officer of Los Angeles County to notify prescribers of the death in their practice. The letter includes the decedent's name, date of birth and date of death, and outlines the annual number and types of prescription drug deaths seen by the medical examiner, discusses the value of and way to access the State's prescription drug monitoring program and includes five Centers for Disease Control and Prevention (CDC) guideline-recommended safe prescribing strategies: 1) Avoid co-prescribing of opioids with benzodiazepines, 2) prescribe minimal dose necessary for acute pain, 3) consider slow tapers with pauses to below 50 MME per day, 4) avoid prescriptions lasting greater than 3-months for pain, and 5) prescribe naloxone in conjunction with opioids for patients taking > 50 MME per day. The letter also states that CURES review is required by law as of October 2, 2018.
15873293|NCT03856593|Behavioral|Letter B|"This letter includes all the details in Letter A plus additional text involving an if/when/then statement along with an injunction to providers to share safety information with patients so that they identify as a safe prescriber. Specifically, the additional text reads as follows: When your next patient presents with pain, keep the above 5 recommendations close at hand to assist with their safe care. Also, be comfortable voicing your concern about prescribing safety with them so that they are also aware of the dangers scheduled drugs may carry. If/when/then is a form of pre-suasion that provides simple rules that tie goals to specific actions and has been used successfully to encourage behavior in many areas including medication adherence and drug abuse rehabilitation."
15873527|NCT03854786|Dietary Supplement|Pacebo|Methyl Crystalline Cellulose
15874347|NCT03848156|Other|biopsy|Biopsy of nasal polyp for RNA sequencing
15873295|NCT03856580|Behavioral|mHealth adherence app|"Participants in the two experimental arms will be given a smartphone application, designed to facilitate adherence (this app will be developed during earlier phases of the study using in-depth interviews and design session groups)"
15873296|NCT03856554|Procedure|Unilateral Transforaminal Interbody fusion|TLIF via unilateral factectomy and insertion of one cage
15873297|NCT03856554|Procedure|Bilateral Transforaminal Interbody fusion|TLIF via bilateral factectomy and insertion of two cages
15873298|NCT03856541|Drug|SHR-A1403|SHR-A1403 is a humanized anti C-Met immunoglobulin G2 (IgG2) monoclonal antibody conjugated with microtubule inhibitor. SHR-A1403 is provided as the lyophilized powder,40 mg/vial.SHR-A1403 was given intravenously per 3 weeks at the day 1.Intravenous infusion over 30 min
15873299|NCT03856528|Other|collection of patient data|Patient data will be obtained using digital patients records systems. The following data will be assessed: Demographics and baseline patient characteristics (e.g., gender, age, hospital admission and discharge dates), diagnoses, comorbidities (history of meningitis and/or encephalitis, epileptic disorders, remote stroke, remote intracranial bleeding, remote autoimmune disease, neurodegenerative disorders), laboratory features (blood cultures, lumbar puncture), features of neuroimaging (e.g., time admission-to-CT), therapeutic features (incl. time admission-to-treatment), Patients' outcome measures (Glasgow Outcome Score)
15873300|NCT03856515|Drug|Nicotine-Containing Standard Research Electronic Cigarette|E-cigarettes with Nicotine
15873301|NCT03856515|Device|Non-Nicotine Standard Research Electronic Cigarette|E-cigarettes without Nicotine
15873302|NCT03856502|Drug|8 mg of dexamethasone|Effect of intrathecally administered dexamethasone in spinal anaesthesia for surgical correction of the hip fracture.
15873303|NCT03856502|Drug|12,5 mg of 0,5 % of levobupivacaine|Local anaesthetic standardly used in spinal anaesthesia for surgical correction of the hip fracture by the particular hospital's protocol.
15873304|NCT03856489|Other|Richards-Campbell Sleeping Questionnaire (RCSQ)|This five-item visual analogue scale was designed as an outcome measure for assessing the perception of sleep in critically ill patients. The scale evaluates perceptions of depth of sleep, sleep onset latency, number of awakenings, time spent awake, and overall sleep quality.
15873305|NCT03856463|Behavioral|Lay Navigator Intervention|Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: education on early advance care planning and documenting goals of care.
15873306|NCT03856463|Other|Usual Care|Usual care as provided by local oncologists
15873307|NCT03856450|Device|DTS|Subjects undergo wrist imaging using DTS.
15873308|NCT03856450|Device|X-ray|Subjects undergo wrist imaging using standard X-ray imaging.
15873309|NCT03856450|Device|MRI or CT|Subjects may undergo wrist imaging using MRI or CT.
15873310|NCT03856437|Behavioral|Framed HPV vaccination messages|Digital multimedia messages consisting of text and imagery conveying the benefits of being vaccinated against HPV or the costs of not being vaccinated against HPV.
15873311|NCT03856424|Procedure|Modality 1|Pressure support ventilation (PSV) modality
15873312|NCT03856424|Procedure|Modality 2|T-Piece modality
15873313|NCT03856424|Procedure|Modality 3|High-flow oxygen
15873314|NCT03856411|Drug|TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy|TORIPALIMAB INJECTION(JS001 ) or Placebo ,240mg/6ml/vial, Q3W,up to 2 years of treatment.
15873315|NCT03856398|Device|C- MAC VS|C-MAC VS, Karl Storz AG, 78532 Tuttlingen, Germany It has a flexible tip and a distal angular offset, in which the camera and light sources are integrated. It can be aligned (up to 60°) to the patient's anatomical structures to facilitate intubation.
15873316|NCT03856385|Behavioral|Mindful Walking|Weekly 60 minute mindful walking sessions involving observations of bodily sensations, experiences, and breath. Discussion of mindful walking experiences and encouragement to meet physical activity goals.
15873317|NCT03856372|Radiation|Hypofractionated|daily fractions, five fractions per week.
15873318|NCT03856372|Radiation|Conventional|daily fractions, five fractions per week.
15873319|NCT03856359|Drug|Rifaximin 550 milligrams (MG)|Rifaximin (Xifaxan, Salix Pharmaceuticals, Bridgewater, N.J.) (See Package Insert) is a drug that is approved by the FDA for use in humans for the treatment of Hepatic Encephalopathy, Traveler's Diarrhea and Irritable Bowel Syndrome. It is commercially available. It will be used in accordance with approved labeling as pertains to dosage and administration for Hepatic Encephalopathy, contraindications and warnings. However, it will be used investigationally in this trial as rifaximin is not FDA approved for the treatment of Alzheimer's Disease.
15873320|NCT03856346|Diagnostic Test|Biometry|Biometry for phaco-vitrectomy procedures pre- and postoperatively
15873321|NCT03856333|Other|Assigned Interventions|exercises, physical agents
15873322|NCT03856320|Behavioral|Educational Video|An educational video describing obesity treatment options available in the VA.
15873323|NCT03856307|Diagnostic Test|point of care ultrasound|to evaluate the reliability of simple pre-specified ultrasound findings acquired at the bedside with a hand-held apparatus with regards to five clinical scenarios most commonly encountered in the hospital, i.e. vaginal bleeding in early pregnancy, pre-eclampsia, prolonged/obstructed labor, antepartum hemorrhage (APH) and high risk pregnancies encountered in ANC.
15873324|NCT03856294|Drug|Rikkunshito|Rikkunshito, 2,5g dissolved in 200 mL lukewarm water, three times daily, 30min before meal intake
15873325|NCT03856294|Drug|Placebos|Placebo, 2,5g dissolved in 200 mL lukewarm water, three times daily, 30min before meal intake
15873326|NCT03856281|Device|Intermittent Pneumatic Compression|Participants administer an intermittent pneumatic compression device in addition to their standard lymphoedema care for a 5 week treatment period
15873327|NCT03856268|Procedure|'Surgical Menopause' Group|Women undergoing laparoscopic oophorectomy surgery ('surgical menopause') will be enrolled at Pennington Biomedical.
15873328|NCT03856268|Drug|'Drug-Induced Menopause' Group|Women undergoing gonadal suppression via leuprolide acetate (Lupron [AbbVie Inc.]) will be enrolled at the University of Colorado-Denver.
15873329|NCT03856255|Device|Micro-Tech Endoscopic Gauge|Use of Micro-Tech Endoscopic Gauge to measure any polyp detected during a screening or surveillance colonoscopy.
15873330|NCT03856242|Drug|Tamsulosin Oral Capsule|Tamsulosin Oral Capsule - alpha-1-adrenoblocker for treatment LUTS/BPH 0.4 mg
15873331|NCT03856242|Procedure|TURP|Routine transurethral prostatic resection
15873332|NCT03856229|Drug|Conventional steroid regimen|Subjects will receive the conventional steroid regimen with prednisolone or equivalent (with methylprednisolone): Day 1 to 5: 40 mg orally every 12 h; Day 6 to 10: 40 orally every 24 hours; and Day 11 to 21: 20 mg orally every 24 h.
15873333|NCT03856229|Drug|Shortened steroid regimen|"Subjects with Moderate PCP. Prednisolone (or equivalent with methylprednisolone) 40 mg orally every 12 h (Day 1 to 5);40 mg orally every 24 hours (Day 6 to 8).
~Subjects with severe PCP. Prednisolone (or equivalent with methylprednisolone) 40 mg orally every 12 h (Day 1 to 5),40 mg orally every 24 hours (Day 6 to 10); and 20 mg orally every 24 h (Day 11 to 14)."
15873334|NCT03856216|Procedure|Allogeneic Bone Marrow Transplantation|Given IV
15873335|NCT03856216|Biological|Anti-Thymocyte Globulin|Given IV
15873336|NCT03856216|Drug|Bendamustine|Given IV
15873337|NCT03856216|Biological|Filgrastim-sndz|Given IV
15873338|NCT03856216|Drug|Fludarabine|Given IV
15873339|NCT03856216|Biological|Inotuzumab Ozogamicin|Given IV
15873340|NCT03856216|Drug|Melphalan|Given IV
15873341|NCT03856216|Drug|Methotrexate|Given IV
15873342|NCT03856216|Procedure|Peripheral Blood Stem Cell Transplantation|Given IV
15873343|NCT03856216|Biological|Rituximab|Given IV
15873344|NCT03856216|Drug|Tacrolimus|Given IV and PO
15873345|NCT03856190|Other|Fasting and plant-based nutrition|The experimental intervention is divided into an initial part with periodic fasting for 7-10 days on an outpatient basis, which is followed by a build-up phase. This group part then receives a diet change with a specific normocaloric nutrition including the concept of time restricted eating (TRE, 16/8h) and according to the following criteria: 1) plant-based, 2) rich in prebiotics, 3) enriched with kitchen spices and kitchen herbs known for their anti-mycotic and anti-inflammatory potential.
15873346|NCT03856190|Other|Standard Nutrition Counselling|The control group receives a diet considered to be fundamentally beneficial to health in the sense of the recommendations of the German Association for Nutrition (DGE), which contain a reduced intake of arachidonic acid and, as a result, modulate an anti-inflammatory effect.
15873347|NCT03856177|Behavioral|Emotion Induction|Described in arm
15873348|NCT03856164|Drug|Tranexamic Acid|Two doses of Tranexamic Acid (1 gram), diluted in 100 cc of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
15873349|NCT03856164|Drug|Placebo|100 mL of normal saline. Administered intravenously at least 10 minutes prior to skin incision and repeated immediately after placental delivery.
15873350|NCT03856151|Device|"HEALTHY BOX Powered heating pad (electronic moxibustion)"|Using heating pad (electronic moxibustion) with insulating materials on low temperatures (56±8℃) in treating patients with intra-dialytic hypotension
15873351|NCT03856125|Other|PENS plus exercise|"The technique will be performed ultrasound-guided on the radial nerve, the places of the needle's insertions will be the following:
~Needle will be placed at under the lateral intermuscular septum between the triceps brachii and brachialis, approximately 10cm superior to the lateral epicondyle
~Needle will be placed at the upper third of the forearm on the posterior interosseous nerve after passing the arcade of Froshe's
~The percutaneous electrical stimulation will be realized with a transcutaneous electric nerve stimulation (TENS) current:
~TENS Frequency - 2 Hz
~TENS Pulse width - 250 microseconds
~Duration - 30 minutes.
~TENS Intensity - Increased at an intensity of visible motor response of the innervated musculature and maximal tolerable intensity.
~Administration - One per week"
15873352|NCT03856125|Other|Sham PENS plus exercise|"The technique will be performed on the radial nerve, the places of the needle's. The technique will be performed ultrasound-guided on the radial nerve, the places of the needle's insertions will be the following:
~Needle will be placed at under the lateral intermuscular septum between the triceps brachii and brachialis, approximately 10cm superior to the lateral epicondyle.
~Needle wil be placed at the at the upper third of the forearm on the posterior interosseous nerve after passing the arcade of Froshe's.
~The current will not be working, and the needles will be placed during 30 minutes.
~- Administration - One per week"
15873353|NCT03856112|Drug|Dexamethasone|Given PO
15873354|NCT03856112|Drug|Ixazomib|Given PO
15873355|NCT03856112|Drug|Ixazomib Citrate|Given PO
15873356|NCT03856112|Drug|Venetoclax|Given PO
15873357|NCT03856099|Drug|TTAC-0001|"Investigational product (IP): TTAC-0001
~Treatment groups: 3 dose groups
~Dose group A : TTAC-0001 16 mg/kg on D1 and D15
~Dose group B : TTAC-0001 20 mg/kg on D1 and D15
~Dose group C : TTAC-0001 24 mg/kg on D1 and D15
~Cycle: 4 weeks (28 days per cycle)"
15873358|NCT03856086|Behavioral|Baseline questionnaire|Baseline questionnaire on the day of the patient's surgery.
15873359|NCT03856086|Behavioral|NCCN Problem List|NCCN Distress Thermometer
15873360|NCT03856086|Behavioral|FACT-GP|Greater overall quality of life
15873361|NCT03856086|Behavioral|HADS|Lower anxiety and depression
15873362|NCT03856086|Behavioral|CSS-CG|web-based CSS-CG
15873363|NCT03856073|Behavioral|Novice|Using the simulate device, the novices in bronchoscopy are going to trained and evaluated the ability of driving bronchoscopy in simulate device and clinical practice.
15873364|NCT03856060|Other|Questionnaire Administration|Complete questionnaires
15873365|NCT03856060|Other|Video|Watch videos of doctor and patient interaction in different settings
15873366|NCT03856047|Drug|NNC0174-0833|Participants will get one dose of NNC0174-0833 once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.
15873367|NCT03856047|Drug|Placebo (NNC0174-0833)|Participants will get one dose of Placebo (NNC0174-0833) once weekly. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using NovoPen® 4. Participants will gradually increase the dose until they reach the target dose, and will continue on the this dose once weekly up to 26 weeks.
15873368|NCT03856047|Drug|Liraglutide 3.0 mg|Participants will get one dose of liraglutide 3.0 mg once daily. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using pre-filled PDS290 pen-injector. Participants will gradually increase their dose every week until they reach the target dose of 3.0 mg daily. The participants will continue on 3.0 mg of liraglutide, once daily up to 26 weeks.
15873616|NCT03854045|Other|Telepsychiatry|Receive telepsychiatry with clinician obtaining initial data and presenting it to the psychiatrist
15873369|NCT03856047|Drug|Placebo (Liraglutide 3.0 mg)|Participants will get one dose of Placebo (liraglutide 3.0 mg) once daily. The medicine is injected with a thin needle in a skin fold in the stomach, thigh or upper arm using pre-filled PDS290 pen-injector. Participants will gradually increase their dose every week until they reach the target dose of 3.0 mg. The participants will continue on Placebo (liraglutide 3.0 mg), once daily up to 26 weeks.
15873370|NCT03856034|Device|Fetoscopy|Patients will receive fetoscopic repair of myelomeningocele. Patients with an anterior placenta will undergo the laparotomy with uterine exteriorization approach. Patients with a posterior placenta will undergo the percutaneous approach (or, if patient prefers, the laparotomy with uterine exteriorization approach).
15873371|NCT03856021|Procedure|Microfracture with Bone Marrow Aspirate Concentrate|Bone Marrow Aspirate Concentrate harvested and prepared from the iliac crest
15873372|NCT03856021|Procedure|Microfracture|All surgeons will use a 2 mm microfracture pick to perform the microfracture procedure. Using the 2 mm pick, surgeons will make 5 holes per 10 cm2.
15873373|NCT03856008|Other|Exercises focused on flexor muscles|Exercises emphasis flexor muscles.
15873374|NCT03856008|Other|Exercises focused on extensor muscles|Exercises emphasis extensor muscles.
15873376|NCT03855982|Drug|Drug inducing myocarditis|Drugs susceptible to induce myocarditis
15873377|NCT03855969|Procedure|Removal of a central venous access device|We are interested in those patients for which a central venous access device was removed.
15873378|NCT03855956|Other|KB174|KB174 is a novel mixture of oligosaccharides.
15873379|NCT03855956|Other|Maltodextrin|Maltodextrin is a commercially available easily digestible polysaccharide.
15873380|NCT03855943|Behavioral|Personalized Computer Program|Training with a personalized computerized inhibitory training program
15873381|NCT03855943|Behavioral|CBT|Cognitive Behavioral Therapy (CBT), consisting of Exposure and Ritual Prevention Therapy
15873382|NCT03855930|Diagnostic Test|functional MRI|During the study, standard motor and sensory paradigms will be performed to establish anatomical and functional patterns in the non-painful state. The patient will then be asked to urinate (to an external collecting tube system).
15873383|NCT03855917|Drug|Sofosbuvir 400mg [Sovaldi]|Four weeks.
15873384|NCT03855917|Drug|Glecaprevir/pibrentasvir (300mg/120mg)|Four weeks.
15873385|NCT03855904|Device|TC-325|TC-325 compounds of inorganic, non-absorbable powder which acts locally at the mucosal tissue. When spraying the powder on to the blood, it will become a stable barrier sheet because of the effect of clotting factors accumulation and, then the normal healing process can be promoted.
15873386|NCT03855891|Diagnostic Test|blood test|Blood test for spectrum and level of cardiospecific micro-RNA
15873387|NCT03855865|Drug|Rapastinel|Rapastinel (prefilled syringe, weekly intravenous IV administration).
15873388|NCT03855865|Drug|Vortioxetine|Vortixetine (10 mg with available dose increase to vortioxetine 20 mg oral daily after 3 weeks of administration).
15873389|NCT03855865|Drug|Placebo|Placebo (prefilled syringe, weekly IV administration or oral daily).
15873390|NCT03855852|Procedure|Xenograft and Collagen membrane|Placing the implant with collagen membrane and xenograft at esthetic zone of maxillary ridge with 2-4 mm thread exposure .
15873391|NCT03855852|Procedure|Xenograft and APRF|Placing the implant with APRF and xenograft at esthetic zone of maxillary ridge with 2-4 mm thread exposure .
15873392|NCT03855839|Device|Posture shirt|Posture shirts are designed, and marketed to the general public and health service providers to improve posture and consequently alter muscle activity, reduce musculoskeletal pain and discomfort.
15873393|NCT03855839|Device|Compression shirt|Compression shirts are designed for recreational sport activities and can be bought in any local sports store
15873394|NCT03855826|Drug|Nifekalant hydrochloride|Both groups were given conventional treatment except for arrhythmia drugs.Only nyficarine hydrochloride or amiodarone hydrochloride could be used according to random results, and the antiarrhythmic drugs should be replaced according to the protocol rules.
15873395|NCT03855826|Drug|Amiodarone|Both groups were given conventional treatment except for arrhythmia drugs.Only nyficarine hydrochloride or amiodarone hydrochloride could be used according to random results, and the antiarrhythmic drugs should be replaced according to the protocol rules.
15873396|NCT03855813|Other|Intra rater reliability|Patients will perform the 30 seconds chair stand test as a self-test twice at home with approximately two days apart. The last self-test should be performed approximately one week before the testing with a physical therapist.
15873397|NCT03855813|Other|Inter rater reliability|Same patients performing the self-test will be tested by a physical therapist approximately one week after the last self-test. The physical therapist will be blind to the self-test results.
15873398|NCT03855800|Diagnostic Test|Blood, stool, pancreatic juice and cyst fluid collection|Blood and stool will be collected at baseline from all study participants. Those in the Immediate Surgery group may undergo endoscopic pancreatic juice collection before surgery, either at the time of a clinically indicated endoscopic ultrasound (EUS) exam or during an optional pre-operative research endoscopy. Pancreatic cyst fluid will also be obtained from all participants in the Immediate Surgery group, either at the time of surgery, or during a clinically indicated preoperative EUS FNA procedure, or both. Pancreatic juice and cyst fluid will be collected opportunistically from participants in the Clinical Follow-up group who undergo a clinically indicated EUS, EUS FNA, or endoscopy exam.
15873399|NCT03855800|Procedure|Pancreatic Surgery|Surgical resection of pancreatic cyst
15873400|NCT03855800|Procedure|Endoscopy Exam|Clinically indicated endoscopic ultrasound
15873401|NCT03855787|Procedure|Ureteroscopy|Ureteroscopy for 1.5cm or less renal stones.
15873402|NCT03855774|Genetic|Polymorphisms|Classification of sleep disorders using 22 genetic polymorphisms
15873403|NCT03855761|Behavioral|Occupational Therapy|Detailed narrative assessment and person-centered participation in meaningful activities
15873404|NCT03855761|Behavioral|Case management; psychological services|Weekly consultation with case managers to address housing and therapy needs
15873548|NCT03854604|Other|postoperative pain assessment|evaluation of the efficacy of PI as an objective measure for postoperative pain assessment in pediatric population undergoing adenotonsillectomy.
15873549|NCT03854591|Other|No intervention|No intervention
15873405|NCT03855748|Other|Healthy group|"Subjects undergo the following activities:
~Walking
~Jogging (8-11 km/h)
~Maximal 5 meters sprint acceleration
~Single leg drop jump from 35 cm height
~Horizontal jump with single leg landing with a distance of 100% and 150% of leg length
~Maximal change of direction at 45, 135, 180 degrees
~Single-leg cross-country skiing exercise"
15873406|NCT03855735|Behavioral|Intervention Group (IG)|The developed short manual for the teaching of different communication models competences will enable those who have been arbitrarily assigned to the intervention group and their relatives to develop secure communication competences. The intervention group will also have access to the digital app.
15873407|NCT03855722|Procedure|RIPC|Remote Ischaemic Preconditioning
15873408|NCT03855722|Procedure|Sham-RIPC|Sham procedure
15873409|NCT03855709|Diagnostic Test|microbiological culture and sensetivity|microbioloical culture will be used to detect microbiological profile in hepatic patients with infections, drug sensitivity to detect resistent bacteria which will be confirmed using PCR detection of resistent gene
15873412|NCT03855683|Behavioral|Unified Protocol for The Treatment of Emotional Disorders|Unified Protocol (UP) is is an 8-week intervention designed to specifically benefit individuals who report co-occurring symptoms of anxiety, stress, and mood by providing them with psychoeducation regarding (mal)adaptive emotion regulation, as well as with skills for effectively responding to stress. UP is based on a cognitive-behavioral framework and uses cognitive and behavioral therapy techniques. Each session of UP group therapy is 90 minutes in duration. Sessions themselves generally include a review of homework and previously discussed concepts, introduction of new material, and in-session discussions/activities.
15873413|NCT03855631|Genetic|Intervention on primary cultured cells|The intervention includes primary cultured cells, reprograming them into mesenchymal stem cells and CRISPR/Case9 gene therapy treatment on patients' cells
15873414|NCT03855579|Drug|Levosimendan|Intraoperative infusion of Levosimendan
15873415|NCT03855579|Drug|Milrinone|Intraoperative infusion of Milrinone
15873416|NCT03855566|Behavioral|Intensive behavioral therapy for obesity|Approximately 24, 20 minute sessions over 12 months focused on diet and physical activity behavior change goals to promote weight loss. Framework includes health belief model, transtheoretical model and motivational interviewing.
15873417|NCT03855553|Behavioral|Family Based Treatment|"10 families will be randomized to receive 10 - 16 weeks of Family Based Treatment (FBT), the gold standard in eating disorder treatment for adolescents. FBT is a highly structured behavioral intervention in which caregivers are charged with the primary task of re-feeding their child and normalizing his or her eating behaviors and weight status."
15873418|NCT03855553|Behavioral|Enhanced Cognitive Behavioral Therapy|10 families will be randomized to receive 10 - 16 weeks of Enhanced Cognitive Behavioral Therapy (CBT-E), a clinically validated treatment for adolescent eating disorders. CBT-E is a short-term, individual treatment focused on normalizing eating behaviors and modifying underlying cognitions that contribute to the maintenance of eating disorder behaviors (e.g., over-importance of shape and weight in one's self-evaluation).
15873419|NCT03855540|Diagnostic Test|ECHOcardiography|"ECHO parameters
~LA diameter
~LVEDD
~LVEF
~Diastolic dysfunction
~Valvular disease"
15873420|NCT03855540|Diagnostic Test|Peripheral blood samples for plasmatic biomarkers|"Coagulation
~D - dimer
~Fibrinogen
~Inflammation and fibrosis
~Hs - CRP
~AGEs
~Soluble RAGE
~Hemodynamics (LA stretch)
~Apelin
~NT - proBNP
~Hs - troponin
~MiRNA
~miRNA - 1
~miRNA - 133
~miRNA - 29b
~miRNA - 208a
~miRNA - 208b
~miRNA - 499"
15873421|NCT03855540|Diagnostic Test|Athens insomnia scale questionnaire|Athens insomnia scale questionnaire
15873422|NCT03855540|Diagnostic Test|ECG Holter monitor|Patient receives ECG Holter monitor if included to the control group
15873423|NCT03855540|Diagnostic Test|ECG event recorder|Patient receives ECG event recorder for twice daily (or if symptoms), 90 seconds duration ECG monitoring if included to the control group
15873424|NCT03855527|Drug|Silver Diamine Fluoride|SDF will be applied as a cavity disinfected after atraumatic restorative technique (Antimicrobial effect)
15873425|NCT03855527|Drug|Chlorhexidine|Chlorhexidine will be applied as a cavity disinfected after atraumatic restorative technique (Antimicrobial effect)
15873426|NCT03855527|Procedure|Atraumatic Restorative Treatment without Disinfection|Atraumatic Restorative Technique will be performed without cavity disinfection
15873427|NCT03855514|Other|NuShield|NuShield® is a dehydrated placental allograft.
15873428|NCT03855501|Other|Mineral trioxide aggregate|Apexification treatment was done with mineral trioxide aggregate
15873429|NCT03855501|Other|Calcium hydroxide|Apexification treatment was done with calcium hydroxide
15873430|NCT03855488|Behavioral|Standard cognitive bias modification|Participants will be asked to repeatedly listen to descriptions of ambiguous scenarios that resolve positively and answer one question following each scenario that reinforces the positive interpretation; participants will listen to 60 scenarios/day for 7 days.
15873431|NCT03855488|Behavioral|Imagery enhanced cognitive bias modification|Participants will be asked to imagine themselves as though they are actively involved in the scenarios that they listen to. This condition will be required to answer two questions following each scenario; one that reinforces the positive interpretation and another that promotes engagement with imagery. Participants will listen to 60 scenarios/day for 7 days.
15873432|NCT03855488|Behavioral|Neutral Control Condition|Participants will be asked to listen to descriptions of neutral (i.e., non-emotional) scenarios. This condition will also be required to answer one comprehension question following each scenario. Participants will listen to 60 scenarios/day for 7 days.
15873433|NCT03855475|Behavioral|Aerobic exercise|Participants will complete 12 weeks of supervised aerobic exercise, 3 times per week, on a treadmill or stationary bicycle
15873434|NCT03855475|Behavioral|Stretching|Participants will complete 12 weeks of supervised stretching, 3 times per week
15873435|NCT03855462|Device|MCT oil injection|"The patient treatment is the classical surgical procedure which is used for retinal detachment with MCT oil :
~Vitrectomy, then flattened retina, and finally MCT injection in place of the vitreous.
~MCT ablation after 4 to 6 weeks (after effective retinopexy)
~after MCT ablation, total follow-up duration by patient is 6 months."
15873550|NCT03854578|Drug|BI 1358894|Film-coated tablet
15873551|NCT03854578|Drug|Placebo matching BI 1358894|Film-coated tablet
15873552|NCT03854578|Drug|Citalopram|Film-coated tablet
15873436|NCT03855449|Behavioral|Task Analysis Intervention Group|Will conduct 9 week in-person group sessions of the DECIDE curriculum with recruited volunteers. This is part 1 or phase I of the eventual pilot clinical trial. Participants will attend weekly group sessions to learn problem-solving skills and management of their diabetes.
15873437|NCT03855423|Dietary Supplement|Tocotrienol-rich Fraction (TRF)|TRF consists of alpha, gamma and delta tocotrienols in addition to small amount of alpha-tocopherol
15873438|NCT03855410|Behavioral|S4E|The face-to-face version of S4E (i.e., Storytelling for Empowerment) is registered as a best-practice with the Substance Abuse and Mental Health Services Administration's (SAMHSA) National Registry of Evidence-Based Practices and Programs.The S4E mHealth app was developed in collaboration with youth in Southeast Michigan. Content produced for the application is based on scientific prevention principles in conjunction with youth input. To date, we have developed modules focused on youth alcohol and drug use, HIV and STIs. We now propose to develop modules focused on tobacco prevention and cessation. S4E aims to increase self-efficacy and communication about health risk behaviors. The face-to-face version of S4E has been shown to prevent and reduce substance use, including cigarette use, as well as increase (1) substance use prevention knowledge, (2) communication about health risk behaviors, and (3) perception of harm and self-efficacy in refusing licit and illicit substances.
15873439|NCT03855410|Behavioral|Attention-Matched Control Group|Participants in the Attention-Matched Control group will receive a PDF version of the tobacco module material, an enhancement to the usual care they would receive should they not join the study. Participants in this group will also receive usual care. The Clinic's usual care includes standard risk behaviors intake form, pamphlets highlighting resources on sexual, physical, and mental health, and other healthcare services.
15873440|NCT03855397|Other|Microneedle|A microneedle patch (no drug) was applied in the following oral cavity sites: lip, buccal, tongue, palatal and gingival mucosa to access pain, discomfort and safety.
15873441|NCT03855397|Other|Hypodermic needle|30 gauge hypodermic needle was inserted in the following oral cavity sites: lip, buccal, tongue, palatal and gingival mucosa.
15873442|NCT03855397|Other|Flat patch|A flat patch was applied in the following oral cavity sites: lip, buccal, tongue, palatal and gingival mucosa.
15873443|NCT03855384|Drug|TQB2450+cisplatin or carboplatin + 5-Fluorouracil (5-FU)|TQB2450 1200mg IV ，cisplatin 75 mg/m^2 IV or carboplatin AUC 5 IV on Day 1 of each week in 3-week cycles (6 cycle maximum); plus 5-FU 750 mg/m^2/day IV continuous from Day 1-5 of each 3- week cycle (6 cycle maximum).
15873444|NCT03855384|Drug|placebo+cisplatin or carboplatin + 5-Fluorouracil (5-FU)|placebo 1200mg IV ，cisplatin 75 mg/m^2 IV or carboplatin AUC 5 IV on Day 1 of each week in 3-week cycles (6 cycle maximum); plus 5-FU 750 mg/m^2/day IV continuous from Day 1-5 of each 3- week cycle (6 cycle maximum).
15873445|NCT03855371|Drug|Decitabine|20mg/m2/d, intravenously, d1-d5, q4w
15873446|NCT03855371|Drug|Arsenic Trioxide|0.16mg/kg/d, intravenously, d1-d5, q4w(maximum dose: 10mg/d)
15873447|NCT03855358|Drug|TQB2450 Injection and Anlotinib Hydrochioride Capsules|TQB2450 1200mg intravenously (IV) every-3-weeks (Q3W) and Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
15873448|NCT03855345|Procedure|Conventional treatment|The treatment will consist of oral hygiene orientation, with instructions of brushing technique and recommendation of the daily use of dental floss. All patients will receive a demonstration of oral hygiene techniques. The calculus deposits on the teeth will be removed with ultrasound equipment and curettes for root scaling and straightening. After the use of ultrasound and curettes, bicarbonate jet will be used to remove dental biofilm. Treatment will be performed in 2 to 4 sessions under local anesthesia (typically 2% mepivacaine with 1: 100,000 noradrenaline). Gracey periodontal curettes (numbers 3/4, 7/8, 11/12 and 13/14) and Mc Call curettes for removal of the dental calculus will be used. Other biofilm-retaining factors, such as carious lesions, condemned teeth, and ill-adapted restorations, will be removed during these periodontal treatment sessions.
15873449|NCT03855345|Radiation|aPDT|aPDT will be performed at the end of each periodontal treatment session, at sites with bags greater than or equal to 4 mm. The photosensitizer PapaMBlue® (F & A Ltda, São Paulo, Brazil) will be deposited in the pouches with a syringe, with the application in coronal direction, and a time of 1 min of pre-irradiation will be adopted so that the substance can stain bacterial biofilm (according to the manufacturer's information). Next, the diode laser emitting wavelength of ʎ=660 nm, with power of P=100 mW, will be applied. The laser will be applied to the mucosa, over the oral epithelium with an optical fiber. Irradiation will be performed until the entire periodontal pocket is illuminated for 2 min at each point. Each irradiation point will be approximately 0.4cm2, which will result in energy density of 30 J/cm2 in 2 min irradiation. The irradiation will have a constant power density of 250 mW/cm2.
15873450|NCT03855332|Drug|Sildenafil|See above
15873451|NCT03855332|Drug|Cilostazol|See above
15873452|NCT03855332|Drug|Placebo|Overencapsulated placebo
15873453|NCT03855319|Behavioral|SMR neurofeedback training to MCI|The intervention consisted to increase the synaptic strengths and sensitivity within this network. Electroencephalography signals for SMR/theta training was recorded at channel Cz according to the international 10-20 system. Theta rhythm was also recorded and, in this case, SMR was stimulated while theta waves were suppressed.A 32 channels system (EEGDigitrcak Biofeedback plus module, Inc Elmiko Medical) was used for the SMR/theta Neurofeedback training.
15873454|NCT03855306|Drug|Glibesyn|1 tablet contains 5 mg Glibenclamide
15873455|NCT03855306|Drug|Daonil|1 tablet contains 5 mg Glibenclamide
15873456|NCT03855293|Procedure|Rhexis protection shield|In the study group the anterior capsule will be used as a protection shield during pacoemulsifikation and removed after the phacoemulsifikation
15873457|NCT03855280|Drug|APVO101|APVO101: 35 - 75 IU/kg; twice weekly
15873458|NCT03855267|Drug|Propofol 20 MG/ML|Pump propofol to keep bispectral index within 40 # 60
15873459|NCT03855267|Drug|Propofol 20 mg/ml , etomidate 2 mg/ml|Propofol was mixed with etomidate in different proportions.keep bispectral index within 40 # 60.
15873460|NCT03855254|Behavioral|communication type|Positive and negative communication types are the way that the practitioner communicates to the participant about the potential effectiveness of the osteopathic treatment. The control is a neutral communication condition.
15873461|NCT03855241|Behavioral|Informational Sheet|The informational sheet details how use opioid medicines safely, and lists ways to properly dispose of leftover opioids
15873462|NCT03855241|Behavioral|DisposeRx Drug Disposal kit|DisposeRx is a powder that is activated with water and traps leftover drugs (i.e. pills, capsules, caplets, liquids or tablets) in a semi-solid gel. The trapped drug cannot be retrieved from the resulting gel material for misuse, abuse or to leach into landfills. The participant can then throw away the biodegradable solid material in the prescription bottle into the trash, as it is safe for the environment.
15873463|NCT03855228|Drug|Mometasone furoate nasal spray (MFNS)|Daily dose of 200 µg of mometasone furoate administered as a nasal spray for 15 days.
15873464|NCT03855228|Drug|Loratadine|Daily dose of 10 mg of loratadine administered as an oral tablet for 15 days.
15873465|NCT03855228|Drug|Placebo nasal spray|Daily dose of placebo administered as a nasal spray for 15 days.
15873466|NCT03855228|Drug|Placebo tablet|Daily dose of placebo administered as an oral tablet for 15 days.
15873467|NCT03855215|Diagnostic Test|ACTIM CRP Rapid Test (Medix, Biochemica)|The implementation of CRP point of care tests will be conducted at commune health centres (CHCs), the primary access point for public health services in Vietnam. In the intervention CHCs, healthcare workers will be trained on the use and interpretation of CRP testing in ARI. healthcare workers can decide to follow the test results or not.
15873468|NCT03855202|Biological|CBMNC|autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg
15873469|NCT03855202|Biological|PS+CBMNC|autologuous umbilical cord blood mononuclear cells 48 hours after birth ,dose is 25 million cells/kg ,PS,dose is 70mg/kg
15873470|NCT03855202|Biological|PS|PS,dose is 70mg/kg
15873471|NCT03855202|Other|Placeo|0.9% sodium chloride installation after 24 hours
15873472|NCT03855189|Drug|Mometasone Furoate (MF)|Mometasone furoate nasal spray administered as 200 mcg total dose per day for 4 weeks.
15873473|NCT03855189|Drug|Beclomethasone Dipropionate (BDP)|Beclomethasone dipropionate nasal spray administered as 168 mcg twice daily (BID) [336 mcg total dose per day] for 4 weeks.
15873474|NCT03855189|Drug|Placebo|Placebo nasal spray administered for 4 weeks.
15873475|NCT03855176|Drug|Vaqta Injectable Product|Inactive vaccine against hepatitis A virus
15873476|NCT03855163|Behavioral|Inspection visits|Normative intervention aimed at enforcing compliance with legal occupational health and safety requirements
15873477|NCT03855163|Behavioral|Guidance workshops|Pedagogical intervention aimed to motivate managers and employee representatives to comply with legal occupational health and safety requirements
15873478|NCT03855163|Behavioral|Online risk assessment tool|Pedagogical intervention aimed to motivate managers and employee representatives to comply with legal occupational health and safety requirements
15873479|NCT03855137|Drug|Atogepant 30 mg|Tablets containing 30 mg atogepant
15873480|NCT03855137|Drug|Atogepant 60 mg|Tablets containing 60 mg atogepant
15873481|NCT03855137|Drug|Placebo|30 mg/60 mg tablets containing atogepant-matching placebo
15873482|NCT03855124|Device|Posture shirt|Posture shirts are designed, and marketed to the general public and health service providers to improve posture and consequently alter muscle actitity, reduce musculoskeletal pain and discomfort.
15873485|NCT03855098|Other|Biomarkers of Fruit and Vegetable Intake|"Cross-over study where participants will visit the Human Intervention Centre (in UCD) on 3 occasions (3 study days) with a minimum one week between each visit. The order of consumption of the test foods will be randomized. The test foods are mixed vegetables (spinach and lettuce), green beans and mixed berried (strawberries and blueberries). The following definition of portion sizes will be used; green beans (120g), lettuce (20g), spinach (90g), strawberries (96g) and blueberries (75g).
~For each study day, the participants will arrive fasting and provide a urine sample (0h sample). For 24h prior to the study day participants will avoid the test foods. Participants will consume the food and urine samples will be taken at 2, 4, 6 and 24 h post consumption."
15873486|NCT03855072|Procedure|customized fixation plate|"All cases will undergo one surgery under general anesthesia.
~Incision was made medial to external oblique ridge from the asendindg ramus to second molar region
~Amucoperiosteal flap was reflected to expose the lateral mandibular ramus to the posterior border and the sigmoid notch
~The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible.
~3D virtual planning and 3D mandible model represented fom CBCT in MIMICS
~The customized fixation plate is positioned to fix the proximal and distal segment together after setback"
15873487|NCT03855072|Procedure|maxillomandibular fixation|"All cases will undergo one surgery under general anesthesia.
~incision was made medial to external oblique ridge from the asendindg ramus to second molar region .
~The intraoral vertical osteotomy is accomplished by using an oscillating saw to make the cut from the sigmoid notch through the inferior border of the mandible.
~Patient is placed in maxillomandibular fixation (MMF) using a prefabricated occlusal splint to assure accuracy of the mandibular position."
15873488|NCT03855059|Drug|Placebos|This will be a saline solution of given IV or perineural.
15873489|NCT03855059|Drug|Dexamethasone Sodium Phosphate|This will be the active drug solution given IV or perineural.
15873490|NCT03855046|Drug|IncobotulinumtoxinA 50 U Intramuscular Powder for Solution|"Sparing surgical removal of fissure without internal sphincter incision is held under spinal anesthesia in surgical room at lithotomy position using electrocoagulation.
~After that Botulinum Toxin Type A is injected into the internal anal sphincter at 1, 5, 7 and 11 o'clock (localization of injection points), 10 U at each point (40 U in total). Botulinum toxin type A (a 50 U vial) is diluted with 1.0 ml of 0.9% saline solution."
15873528|NCT03854773|Other|Erector spinae plane block (Group ESPB)|Patients will be administered A 400 mg dose of ibuprofen every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
15873553|NCT03854565|Diagnostic Test|Glycocalyx measurement，respiratory mechanics measurement|ELASA measure glycocalyx, measure plateau pressure, driving pressure
15873554|NCT03854552|Drug|BI 764198|capsule
15873491|NCT03855046|Procedure|Lateral subcutaneous sphincterotomy.|The patient is positioned on the table like for perineal lithotomy. After spinal anesthesia, the anal canal and then the surgical field are treated with 70% ethanol. Under the rectal speculum control, sparing surgical removal of fissure without internal sphincter incision is held using electrocoagulation.Then, in a 3 or 9 o'clock position, a narrow (eye) scalpel is inserted into the intersphincteric groove separating the external and internal sphincters, the scalpel blade is turned to the rectal lumen, and the internal sphincter is dissected up to the wall of the anal canal mucosa under the control of the finger inserted into the anal canal. After controlling hemostasis, the operation is ended with the introduction of the vent tube and hemostatic sponge.
15873492|NCT03855033|Behavioral|Media Aware Sexual Health - High School|Media Aware Sexual Health is a web-based comprehensive sexual health education program for high school students that uses a media literacy approach.
15873493|NCT03855020|Diagnostic Test|Plasma EBV DNA|Parameters analyzed will include (1) the changing pattern of plasma EBV DNA concentrations during chemotherapy and radiotherapy (2) half-life values (t1/2) of plasma EBV DNA clearance rate
15873494|NCT03855007|Drug|Iguratimod|Iguratimod tablet，25mg, po, twice per day (Bid) prescribed at the beginning and adjusted due to patient response. Then may titer down until the endpoint.
15873495|NCT03855007|Drug|MTX|MTX，7.5mg to 15mg, po, once per week (Qw) prescribed if needed and adjusted due to patient response or unacceptable toxicity develops.
15873496|NCT03855007|Drug|HCQ|HCQ，200mg, po, twice per day (Bid) prescribed if needed and adjusted due to patient response.
15873497|NCT03855007|Drug|Pred|Pred, 5-15mg, po, once per day (Qd) prescribed if needed and adjusted due to patient response
15873498|NCT03854994|Biological|Anti-CD19 CAR-T Cells Injection|Autologous genetically modified anti-CD19 CAR transduced T cells
15873499|NCT03854981|Behavioral|Exercise|Subjects will be asked to exercise 5 days/week in addition to receiving standard care before bariatric surgery.
15873500|NCT03854981|Procedure|Standard Care|Standard preoperative care of bariatric surgery
15873501|NCT03854968|Other|Quality control|The performance of the home mechanical ventilator of all patients in the study will be evaluated with a portable device
15873502|NCT03854955|Other|iScribes|Device-based scribing service.
15873503|NCT03854942|Drug|Placebo|Placebo oral tablet daily
15873504|NCT03854942|Drug|Naltrexone|Naltrexone (Nemexin) oral tablet 50 mg daily for 2 days, Naltrexone (Nemexin) oral tablet 100 mg daily for 5 days
15873505|NCT03854929|Drug|Ciprofloxacin|"Fluoroquinolone, ATC code: J01MA02
~DNA-gyrase and topoisomerase IV inhibitor"
15873506|NCT03854929|Drug|Azithromycin|"Macrolide, ATC code: J01FA10
~Binds to ribosomal 50S sub-unit inhibiting translocation of peptides thereby suppressing bacterial protein synthesis."
15873507|NCT03854916|Other|Caminemos Juntas App|A tailored mobile app that encourages Latinas and Hispanic women to walk together using location-based services.
15873508|NCT03854916|Other|World Walking App|A mobile app that encourages users to walk.
15873509|NCT03854903|Drug|Palbociclib|Palbociclib is taken orally.
15873510|NCT03854903|Drug|Bosutinib|Bosutinib is taken orally.
15873511|NCT03854903|Drug|Fulvestrant|Fulvestrant is given as an intramuscular injection.
15873512|NCT03854890|Drug|Indocyanine Green|Indocyanine Green will be injected to the submucosal layer around the lesion one day before surgery.
15873513|NCT03854877|Behavioral|Health behaviour intervention|The intervention uses the principles of acceptance-commitment therapy (ACT). It aims to increase healthy eating and good sleep. Based on personal needs participants can choose task for physical activity, relaxation, healthy eating, sleep eg. Their get regular feedback and support from their personal trainer via phone and computer.
15873514|NCT03854864|Other|survey|to assess the current practices of management by oncologists in France in 2019, for any type of practitioners of university hospital, or general hospital, for all type of neurotoxic anticancer drugs.
15873515|NCT03854851|Drug|Naldebain|In Naldebain group, patients will be injected with Naldebain (150 mg/2 ml, IM injection) between 12 and 24 hours prior to surgery.
15873516|NCT03854851|Drug|Morpine|In Morphine group, patients will receive morphine as needed after surgery.
15873517|NCT03854838|Drug|Tolipalimab|Radiation begun the day after the first dose of Toripalimab. Toripalimab (240mg dose every 3 weeks for 7 cycles, one cycle is three weeks) will be administered as an intravenous infusion over 60 minutes.
15873518|NCT03854838|Radiation|Reirradiation|intensity-modulated radiation therapy (IMRT), 60 Gy 2.2Gy per fraction ,5 fractions per week, for 6 weeks
15873519|NCT03854825|Procedure|Cardiac surgery|
15873520|NCT03854812|Drug|Magnesium Sulphate|a loading of 50 mg/kg in 15 minutes of Magnesium sulphate, and will be followed by continuous infusion at 1 ml/kg/h of 15 mg/ml solution
15873521|NCT03854812|Drug|Fentanyl|loading of 1 mcg/kg in over 15 minutes of fentanyl then will receive continuous infusion starting at 1 ml /kg/h. of 0.5 mcg/ml solution
15873522|NCT03854812|Drug|Propofol|0.5-1.5 mg/kg bolus of propofol over 10 minutes to achieve target Ramsay sedation scale (RSS) of 3 (respond to command), if RSS afterwards does not reach 3 a supplementary bolus dose of 0.2 mg/kg propofol will be given to the patients, and will be followed by 1-2.5 mg/kg/hr infusion to maintain Intraoperative BIS readings between 60 - 80
15873523|NCT03854799|Drug|Avelumab|"Eligible patients will receive:
~CHEMORADIOTHERAPY PLUS AVELUMAB:
~CAPECITABINE 825 mg/sqm/bid p.o. 5 days/week
~EXTERNAL-BEAM IRRADIATION 50.4 GY in 28 fractions over 5.5 weeks
~AVELUMAB 10 mg/Kg ev over 1 hour every 2 weeks at days 1, 14, 28, 42, 56, 70
~Surgery with TME must be performed at week 8-10 after the end of CTRT. The final choice of surgical procedure (ie, abdominoperineal surgery or anterior resection) is at the surgeon's discretion."
15873524|NCT03854799|Drug|Capecitabine|"Eligible patients will receive:
~CHEMORADIOTHERAPY PLUS AVELUMAB:
~CAPECITABINE 825 mg/sqm/bid p.o. 5 days/week
~EXTERNAL-BEAM IRRADIATION 50.4 GY in 28 fractions over 5.5 weeks
~AVELUMAB 10 mg/Kg ev over 1 hour every 2 weeks at days 1, 14, 28, 42, 56, 70
~Surgery with TME must be performed at week 8-10 after the end of CTRT. The final choice of surgical procedure (ie, abdominoperineal surgery or anterior resection) is at the surgeon's discretion."
15873525|NCT03854799|Radiation|EXTERNAL---BEAM IRRADIATION 50.4 GY|Surgery with TME must be performed at week 8-10 after the end of CTRT. The final choice of surgical procedure (ie, abdominoperineal surgery or anterior resection) is at the surgeon's discretion.
15873526|NCT03854786|Dietary Supplement|Oxyjun|Oxyjun is the proprietary single ingredient product containing high concentrated well standardized aqueous extract of Terminalia arjuna.
15873529|NCT03854773|Other|Thoracal paravertebral block (Group TPVB)|Patients will be administered A 400 mg dose of ibuprofen every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
15873530|NCT03854773|Other|Control group (group C)|Patients will be administered A 400 mg dose of ibuprofen every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.
15873531|NCT03854760|Behavioral|anesthesiologist with limited experiment|Using the simulate device, the trainees are going to trained and evaluated the ability of driving bronchoscopy in simulate device and clinical practice.
15873533|NCT03854734|Behavioral|Community Event|Formative focus group data was used to design an educational community event to improve information share and vaccine education/knowledge.
15873534|NCT03854734|Behavioral|Educational Material|Formative focus group data was used to design educational messaging to be electronically distributed to intervention participants
15873535|NCT03854721|Drug|VAX014|Solution for intravesical infusion, 3.33x10^10 rBMCs per vial
15873536|NCT03854708|Drug|3 pmol/kg*min pancreatic polypeptide|PP 3 pmol/kg*min was intravenously infused 30 minutes before the meal until the end of the meal. For this purpose, a cannula was inserted into the subjects' forearm vein. Human PP (CS Bio, Menlo Park, USA) was dissolved in a 0.9 % saline solution containing 5 % albumin to reduce absorption of PP to the syringe and tubing.
15873537|NCT03854708|Drug|10 pmol/kg*min pancreatic polypeptide|PP 10 pmol/kg*min was intravenously infused 30 minutes before the meal until the end of the meal. For this purpose, a cannula was inserted into the subjects' forearm vein. Human PP (CS Bio, Menlo Park, USA) was dissolved in a 0.9 % saline solution containing 5 % albumin to reduce absorption of PP to the syringe and tubing.
15873538|NCT03854708|Drug|Placebo|Placebo (saline solution) was intravenously infused 30 minutes before the meal until the end of the meal. For this purpose, a cannula was inserted into the subjects' forearm vein. The placebo consists of a 0.9 % saline solution containing 5 % albumin.
15873539|NCT03854682|Procedure|Radiofrequency microtenotomy|A longitudinal incision of about 3 cm will be made over the most tender part of the foot taking care to avoid the weight bearing part of the sole, and the tissues dissected down to the affected plantar fascia. After initiating sterile isotonic saline flow of 1 drop every 1-2 s from a line connected to the RF system, the TOPAZ tip will be placed onto the fascia and the micro debridements carried out in a grid like pattern on and throughout the symptomatic fascia area. After debridement, the wound will be irrigated with copious amounts of normal saline solution and closed in layers. A local anaesthetic will be injected into the skin and subcutaneous tissues around the wound and standard wound dressings will be applied
15873540|NCT03854682|Behavioral|Strength training|Non-surgical treatment consists of one-legged heel lift to primarily activate the windlass effect and increase the mechanical stress on the tendon. The exercise is performed on a step, a thick book or the like, so the heel movement finishes below the horizontal level. The exercise is performed every other day with as many sets as possible and as heavy as possible, but not heavier than eight repetitions can be performed per. set. The load progressed from two to one leg +/- backpack. The exercise is performed as 3 s/2 s / 3 s concentric, isometric and eccentric respectively followed by 2 min rest. Patients continue to exercise 4 weeks after patient acceptable symptom state (PASS) has been achieved
15873541|NCT03854669|Device|pain reporting accuracy|pain reporting accuracy will be assessed by the Focused Analgesia Selection Task (FAST) procedure. The FAST is based on recording a subject's pain reports in response to repeated administration of thermal noxious stimuli of various intensities, applied on the non-dominant arm with the Medoc® Thermal Sensory Analyzer II. The subjects will receive 1 of 7 designated temperatures (44°C, 45°C, 46°C, 47°C, 48°C, 49°C, and 50°C), each presented 7 times in a random block-ordered design (49 stimuli in total).
15873542|NCT03854656|Other|Time-restricted eating|"Participants will be instructed to eat within a self-selected 10-hour timeframe between 6AM and 8PM every day. All food/beverages except water must be consumed within the time-interval. Staff will help participants select a time-interval that fits into their daily life and optimally fulfil the following guiding principles:
~The first food item/beverage of the day should optimally be ingested at least 2 hours after usual wake-up time
~The last food item/beverage of the day should optimally be ingested at least 3 hours before usual bed time
~Diet is ad libitum and with no further dietary restrictions. Participants will receive advice about a healthy lifestyle according to the national dietary recommendations from the Danish Health Authority."
15873543|NCT03854643|Other|Pilates group|Pilates exercises were performed three times a week for 4 weeks, totaling 12 treatment sessions. Each session lasted 40 minutes and was performed by a researcher with training in the method and previous training in the exercise. The patients were evaluated as follows: initial assessment, after two weeks, after four weeks and a follow up after three months.
15873544|NCT03854643|Other|Control group|These patients did not receive any type of intervention. The patients were evaluated as follows: initial assessment, after two weeks, after four weeks and a follow up after three months.
15873545|NCT03854630|Drug|Engerix-B|The vaccine contains HBsAg which was produced by genetic engineering yeast. It stimulates the active immunity generated by human immune system toward the HBsAg.
15873546|NCT03854617|Drug|Oral NVB Metronomic|50mg three times weekly on Mondays (or Tuesdays), Wednesdays (or Thursdays) and Friday (or Saturdays). A cycle is a 3 weeks period.
15873547|NCT03854617|Drug|Oral NVB Weekly|60mg/m2 weekly for cycle 1 and 80mg/m2 weekly for subsequent cycles in the absence of grade 3 or 4 toxicity. A cycle is a 3 weeks period
15873555|NCT03854552|Drug|Placebo|capsule
15873557|NCT03854526|Other|Evaluation of the quality of direct and indirect partial dental coronal restorations in adults|"The medical and dental anamnesis are registered. In addition to the medical history questionnaire, the patient completes the self-assessment questionnaire on oral health. Then, a complete and intra-oral clinical examination is performed. The collection of clinical data is done on the dentist's chair. All data are included in the e-CRF.
~All radiographic procedures will be performed according to national guidelines. If the investigator deems it clinically necessary, a panoramic X-ray will be taken and stored in the patient's HER system. Periapical radiographs (using a parallelogram technique with a radiographic film holder) will be taken for teeth with periapical radiolucency on panoramic X-ray, or with defective coronal restoration, or when the clinician needs more information for diagnosis or planning."
15873558|NCT03854513|Device|dialysis machine|A machine used in dialysis that filters a patient's blood to remove excess water and waste products when the kidneys are damaged
15873559|NCT03854500|Drug|Tenecteplase|0.4 mg/kg single bolus intravenously
15873560|NCT03854500|Drug|Alteplase|0.9 mg/kg as 10% bolus + 90% infusion/60 minutes intravenously
15873561|NCT03854487|Behavioral|Mirror therapy|A mirror is placed at the midsagittal plane of the patient. The patients in the mirror therapy group watched the mirror illusion of the non-affected arm in the mirror and moved together with the affected arm. The treatment programme for all groups consisted of 12 sessions (4 per week for 3 weeks), each lasting for 30 minutes. The movement practice involved 5 table-top tasks and the patient was instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session. Treatment activities are graded according to the severity of the patient's upper extremity impairment.
15873562|NCT03854487|Behavioral|Sham mirror|A transparent glass wall is placed at the midsagittal plane of the patient. The patients in the sham mirror group watched the movements of the affected arm through the transparent glass wall and moved together with the non-affected arm. The treatment programme for all groups consisted of 12 sessions (4 per week for 3 weeks), each lasting for 30 minutes. The movement practice involved 5 table-top tasks and the patient was instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session. Treatment activities are graded according to the severity of the patient's upper extremity impairment.
15873563|NCT03854487|Behavioral|Covered mirror|A covered mirror is placed at the midsagittal plane of the patient. The patients in the control group watched the movements of the non-affected arm and moved together with the affected arm behind the covered mirror. The treatment programme for all groups consisted of 12 sessions (4 per week for 3 weeks), each lasting for 30 minutes. The movement practice involved 5 table-top tasks and the patient was instructed to perform as many trials as possible in each session with a maximum of 30 trials per task, giving a total of 150 trials per session. Treatment activities are graded according to the severity of the patient's upper extremity impairment.
15873566|NCT03854461|Behavioral|Personalised dietary advice and educational material|As within arm/group description
15873567|NCT03854461|Behavioral|Educational material|As within arm/group description
15873568|NCT03854448|Device|holter monitoring|"Transthoracic Echocardiography (TTE) Left atrial ( LA) volume will be measured using standard apical two- and four-chamber views on the frame just prior to mitral valve opening and as specified by current American Society of Echocardiography guidelines (10) LA volume is indexed to body surface area. Mitral inflow velocity is obtained in the apical four-chamber view by placing a pulsed-Doppler sample volume between the tips of the mitral leaflets. Mitral annular velocity is assessed during the early phase of diastole(e=) using pulsed-wave Doppler sampling of septal mitral annular motion from the four chamber view.
~24 to 48 hours Holter monitoring after 1 month after PCI"
15873569|NCT03854435|Other|Heart rate assessment (stethoscope)|Immediately after birth heart rate will be evaluated by auscultation
15873570|NCT03854435|Other|Heart assessment (umbilical cord palpation)|Immediately after birth heart rate will be evaluated by palpation of the umbilical cord
15873571|NCT03854422|Device|left position|colonoscopy will be performed in 3 different locations. Left position, the patient will be in the left-side position during the entire colonoscopy
15873572|NCT03854422|Device|left supine position|Colonoscopy in the Left supine position
15873573|NCT03854422|Device|dynamic position|Colonoscopy in the Dynamic position
15873574|NCT03854409|Drug|Aripiprazole|Injection.
15873575|NCT03854396|Drug|Prasterone|Nightly intravaginal prasterone insert (6.5 mg prasterone at a concentration of 0.50%) for 24 weeks.
15873576|NCT03854396|Drug|Placebo|Nightly intravaginal placebo insert (Witepsol H-15, a mix of synthetic triglycerides) for 24 weeks.
15873577|NCT03854383|Drug|Isosorbide mononitrate|Administration of isosorbide mononitrate vaginaly together with misoprostol in induction of labor in postdate women
15873578|NCT03854383|Drug|Misoprostol|Used intravaginally to ripe the cevix in induction of labor
15873579|NCT03854370|Other|Baby shampoo|baby shampoo will be used to prepare the surgical site prior to incision
15873580|NCT03854370|Other|Betadine|Betadine (Povidone- iodine) will be used to prepare the surgical site prior to incision
15873581|NCT03854370|Other|Peridex|Peridex (Chlorhexidine) will be used to prepare the surgical site prior to incision
15873582|NCT03854370|Other|TechniCare|TechniCare (chloroxynel) will be used to prepare the surgical site prior to incision
15873583|NCT03854357|Procedure|Subscapularis Rehabilitation|Specific subscapularis rehabilitation exercises which are not included in the current, standard rehabilitation protocol assigned to total shoulder arthroplasty patients post-operatively.
15873584|NCT03854357|Procedure|Standard Rehabilitation|Standard post-operative rehabiliation protocol assigned to all total shoulder arthroplasty patients postoperatively
15873585|NCT03854344|Drug|Lidocaine Hydrochloride|Injected subcutaneously for skin graft harvesting
15873586|NCT03854344|Drug|Liposomal bupivacaine|Injected subcutaneously for skin graft harvesting
15873621|NCT03854019|Drug|Dextromethorphan/quinidine 20mg/10mg (DM/Q 20mg/10mg)|DM/Q 20mg/10mg one capsule once daily for 1 week, followed by DM/Q 20mg /10 mg twice daily for subsequent 4 weeks, and finally DM/Q 20mg/10mg once daily for 7days.
15873587|NCT03854331|Behavioral|Resilience program|The resilience program consists of different modules that are based on research on mentalization, mindfulness, parent management training, improving self-control and self-efficacy, cognitive behaviour therapy, social learning theory and neuroscience. The MyResilience program is also informed by cognitive bias modification and self-control training research. These techniques have been found to be effective in improving engagement in health behaviours and reducing symptoms and negative behaviours in clinical groups
15873588|NCT03854305|Drug|PRV-6527|Treatment
15873589|NCT03854305|Drug|Placebo|Comparator
15873590|NCT03854292|Procedure|Hysteroscopic tubal electrocoagulation|Unilateral or bilateral electrocoagulation of the cornual end of the tube and the surrounding part of the uterine horn was performed using a hysteroscopicelectrocoagulating roller ball.
15873591|NCT03854279|Device|tonsillar dissection|The tonsils will be removed by bizact device
15873592|NCT03854266|Drug|Low dose alteplase|Low dose alteplase is 4 milligram per pulmonary artery (maximum dose 8 milligram) infused in the pulmonary arteries over 2 hours
15873593|NCT03854266|Drug|Unfractionated heparin|Unfractioned heparin is administered in a peripheral vein with an initial dose of 80 international units per kilo (IU/kg) bolus followed by 18 IU/kg as continuous infusion with dose adjustment every 6 hours and once daily when activated partial thromboplastin time (APPT) is 1.5-2.3 times control value.
15873594|NCT03854266|Device|Infusion catheter|A sidehole catheter (Unifuse, AngioDynamics, US) catheter will be advanced to the pulmonary arteries to facilitate the catheter directed thrombolysis
15873595|NCT03854253|Procedure|Long introducer sheath|The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-25cm
15873596|NCT03854253|Procedure|Short introducer sheath|The investigators will perform transradial coronary angiography and percutaneous coronary interventions using introducer sheath 6Fr-10cm
15873597|NCT03854240|Other|Classic block (Group C) and modified block (Group M) groups|Classic block (Group C) and modified block (Group M) will be performed following induction of general anesthesia, with patients in the prone position by using ultrasound device
15873598|NCT03854227|Drug|PF-06939999 dose escalation|PF-06939999 orally at escalating doses on a continuous basis
15873599|NCT03854227|Drug|PF-06939999 monotherapy|PF-06939999 at the recommended Phase 2 dose orally on a continuous basis
15873600|NCT03854227|Drug|PF-06939999 in combination with docetaxel|PF-06939999 orally on a continuous basis in combination with docetaxel
15873601|NCT03854214|Device|Functional Electric Stimulation cycling|The Functional Electrical Stimulation (FES) cycling group will use RT300 ergometer (Restorative Therapies, Inc). Bilateral glutei, quadriceps and hamstrings will be stimulated. The stimulation parameters will be set as follows: waveform biphasic, charged balanced; phase duration of 250 microseconds; pulse rate 33-45 pps. The stimulus intensity will be adjusted for individual patients and muscle group so that a tolerable stimulation is provided that will generate a cycling action. Target cycling speed is 50 RPM. Resistance will be automatically adjusted by the FES bike according to the subject's performance. When fatigue occurs, participants will continue cycling with electrical stimulation and motor support. FES therapy will be administered for one hour per session 3 times a week.
15873602|NCT03854214|Device|Passive cycling|The passive cycling group will use the same RT300 ergometer however during this period stimulation will not be turned on. Instead, continuous motor support will be activated resulting in passive cycling. Target cycling speed is 50 RPM. Participants assigned to passive cycling will be required to have one hour of passive therapy 3 times a week for the entire duration of treatment assignment.
15873603|NCT03854201|Behavioral|Personalized Exercise Counseling (PEC)|At the first counseling appointment, PEC-participants answer the physical activity (PA) questionnaire, perform fitness tests and discuss with their exercise instructor. The target is a personalized short-term PA plan including where and when the PA/exercise takes place and what is the mode. Participants may choose instructed group-exercise sessions provided by the municipal sports/leisure sector or exercising alone as preferred. The exercise instructors utilize the fitness test results and feedback data of the research accelerometers by the UKK Institute to guide the participants. The PEC includes 2 more face-to-face sessions and 4-6 phone calls by the instructors aimed at checking the realization of exercise plans and discussing the outcomes provided by the interactive accelerometer.
15873604|NCT03854188|Procedure|Acupuncture|Use acupuncture therapy in the treatment of chronic pelvic pain.
15873605|NCT03854175|Drug|sildenafil citrate|25mg vaginally every 6 hours (a half of 50 mg tablet is crushed and dissolved in 2cc of distilled water and injected in to vagina) starting from day 2-14 of the cycle
15873606|NCT03854175|Drug|Estradiol Valerate 2 MG|2mg 6-8 hourly from the day 2-14 of the cycle to prepare the endometrium
15873607|NCT03854162|Device|SMART Guide|The device manufactured according to a digital plan based on patient anatomy. Guiding sleeves are used, through which bone drills are applied. These sleeves sit in a plastic template that is a negative of the patient's dentition, so that the guide is properly stabilized during the operation. The position of the sleeves is calculated from the surgical plan in a way that they guide the drills in the planned position.The material of the template is medical plastic, the sleeves are made of medical steel.The device is applied by the dentist during the implant surgery. The template is placed on the remaining dentition of the patient and stabilized this way. By this, the sleeves are also stabilized in their planned position. Access through the soft tissue can be prepared through the given sleeve with a circular trephine, but the system also supports flap surgery. As access has been established, the dentist performs the surgical protocol as planned.
15873608|NCT03854136|Procedure|Excision of tumor|Wide margin excision of tumors +/- limb preservation
15873609|NCT03854110|Drug|GP-2250|GP-2250 monotherapy for pharmacokinetics; GP-2250 plus gemcitabine for tolerability and biomarker assessments
15873610|NCT03854097|Device|Active Intermittent Negative Pressure (INP)|Application of -40mmHg negative pressure on the lower limb
15873611|NCT03854097|Device|Placebo Intermittent Negative Pressure (INP)|Application of -10mmHg negative pressure on the lower limb
15873612|NCT03854084|Other|The cranial osteopathic techniques|Technique of the temporal bones in favor of the free movement. Ear Pull technique: the hands of the osteopath holds the auricle of the individual with the thumb, index and the middle finger in a tweezer shape and with the elbows resting over the stretcher. Ruddy technique: The osteopath puts the thumbs on the eyelid of each eyeball.
15873613|NCT03854084|Other|Control group|Simulation of the techniques was used in the interventional group
15873622|NCT03854019|Drug|Placebo|Placebo once daily for 1 week, followed by placebo twice daily for subsequent 4 weeks, and finally placebo once daily for 7days.
15873623|NCT03854006|Procedure|Cryoballoon pulmonary vein isolation|During cryoballoon pulmonary vein isolation, under local anaesthesia, diagnostic catheters are placed in the coronary sinus. The cryoballoon is advanced to the left atrium via a steerable sheath after single transseptal puncture and inflated at the PV(pulmonary vein) ostia. A spiral mapping catheter is advanced through the balloon inner lumen and positioned in the PV at the closest achievable proximity to the cryoballoon in order to record real-time PV potentials during PV isolation. During PV isolation the potentials from the PV are recorded. The TTI is defined as the time of the last recording of a PV potential before sustained isolation. Isolation of all PVs is reassessed at the end of the procedure by documentation of entrance- and exit-block.
15873624|NCT03853993|Biological|Quadrivalent influenza vaccine|Received single dose QIV (15µg/0.5ml)
15873625|NCT03853993|Biological|Trivalent influenza vaccine (contains B/Victoria strain)|Received single dose TIV which contains B/Victoria strain (15µg/0.5ml)
15873626|NCT03853993|Biological|Trivalent influenza vaccine (contains B/Yamagata strain)|Received single dose TIV which contains B/Yamagata strain (15µg/0.5ml)
15873627|NCT03853980|Device|Focal Contouring System|Single treatment of skin resection (removal of loose skin)
15873628|NCT03853967|Other|Low dose CT scan|low dose CT scan
15873629|NCT03853954|Device|Methoxyflurane|Methoxyflurane (Penthrox) inhaler, 3mL inhalation vapour, liquid
15873630|NCT03853941|Behavioral|Intervention|Theory-based communication training programme delivered to healthcare professionals
15873631|NCT03853928|Dietary Supplement|Probiotics|"Each 50 ml bottle contains Lactobacillus casei 3.3 x 107 CFU / day, Lactobacillus plantarum 3.3 x 107 CFU / day, Streptococcus faecalis 3.3 x 107 CFU / day and Bifidobacterium brevis 1.0 x 106 CFU / day (BIOFLORA®, BIOSIDUS SA, Argentina) .
~Medication Reference intervention. Name of the active substance: Placebo. Administration way: Oral 5 ml orally every 12 hours for 10 consecutive days (Cycle, monthly)
~Likewise, both branches will explicitly request the non-consumption of alcohol and the consumption of a non-hypercaloric Mediterranean diet throughout the study for all patients in each branch (ANNEXIII)."
15873632|NCT03853915|Diagnostic Test|[18-F]- FDG - PET|[F-18]-FDG Injection is an intravenous diagnostic radiopharmaceutical used for Positron Emission Tomography. While this is not the subject of investigation in this study, [F-18]-FDG will be used in the PET imaging assessment of study participants during their 3 month follow-up post-treatment.
15873633|NCT03853902|Behavioral|Mindfulness Program|Mindfulness Program
15873634|NCT03853889|Procedure|USG guided ONSD measurement preepidural|Measurement of the diameter of the optic nerve sheath preepidural and postepidural anesthesia
15873635|NCT03853863|Behavioral|in-school walking training with minimalist shoes|Participants in the MSW group will be given a pair of minimalist shoes for all in-school activities (i.e., 5 days/week and 7 hours/day) for 12 weeks. Similar to previous minimalist footwear studies, the intervention duration will be gradually increased over the 12-week training. In brief, subjects will wear the minimalist shoes for 1 out of 5 school days at the first week; 2 days at the second week, and so on until fully use of the minimalist shoes at the fifth week.
15873636|NCT03853863|Behavioral|in-school walking training with protective shoes|Participants in the TSW group will be given a pair of given a pair of protective shoes with arch support for all in-school activities (i.e., 5 days/week and 7 hours/day) for 12 weeks,while follow the same wearing pattern as the MSW group.
15873637|NCT03853850|Behavioral|Mobile phone text messages|From their babies' day of birth until 6 months of age, participating mothers will receive supportive and educational text messages to promote breastfeeding. Messages will be on benefits of breastfeeding, newborn hunger cues, proper latch technique, healthy infant feeding practice, and maternal self care. Messages will be sent regularly, initially several messages every day during the babies' first few weeks of life, then few messages every week. A total of 158 (***) messages will be sent. Messages will be sent in English or in Spanish depending on participant language preference.
15873638|NCT03853837|Diagnostic Test|rest-exercise echocardiography|an echocardiogram performed during rest and exercise
15873639|NCT03853824|Other|Increased postoperative surveillance|Increased postoperative surveillance can include either of the following; i) admission to a higher care ward than had been planned at the time of surgery, ii) an increase in the frequency of nursing observations in the postoperative period, iii) ensuring that the patient is placed in view of the nursing station, and not in a remote location in the postoperative ward, or iv) allowing family members to stay with the patient in the ward in the postoperative period.
15873640|NCT03853824|Other|Usual postoperative care|Participating sites randomised to the control arm will provide usual postoperative care to patients. The care will be left to the discretion of the healthcare providers.
15873641|NCT03853811|Device|Ankle Foot Orthosis (AFO)|The intervention group will receive the custom AFO to use in their standard Mitchell shoe.
15873642|NCT03853798|Drug|AG-348|Participants will receive 5, 20, or 50 mg twice a day for up to 192 weeks (not including dose taper) unless the dose is modified for reasons related to safety.
15873643|NCT03853785|Biological|MMR vaccine|Intralesional injection of 0.5 ml MMR vaccine in the largest lesion . Injections will be repeated into the same lesion every 2 weeks for a maximum of three treatment sessions.
15873644|NCT03853785|Biological|Candida antigen|Intralesional injection of Candidal antigen with a dose of (0.1ml -0.3ml) by an insulin syringe in the largest wart at the first visit. Injections will be repeated for all patients into the same lesion every 2 weeks for a maximum of three treatment sessions.
15873645|NCT03853785|Drug|Topical Podophyllin|It will be applied to the wart by using a cotton tipped swab once a week . The procedure will be limited to 10 cm2 per session .Surrounding skin will be protected by Vaseline. Podophyllin will be washed 4 hour after application . The procedure will be repeated every week till 6 weeks .
15873646|NCT03853746|Drug|Ocrelizumab|Patient will be treated with two courses of ocrelizumab (Ocrevus) for one year and then will stop the medication and will be monitored for the return of the disease activity. Those who experience return of the disease activity can go back on the medication.
15873647|NCT03853733|Radiation|rectal cancer radiotherapy|Conformal three-dimensional radiotherapy to deliver to the primary tumor and the enlarged pelvic nodes a total dose of 39Gy in 13 sessions of 3Gy in 17 days.
15888386|NCT03740165|Drug|Olaparib|Oral tablet
15873648|NCT03853720|Procedure|balloon-occluded retrograde transvenous and endoscopic obliteration of high-risk gastric varices|"Catheterization of the left renal vein and the inferior diaphragmatic vein and occlusion with a balloon placed in the distal portion of this vein.
~Endoscopic access to the gastric cavity, gastric varices identification and flow measurement, including velocity, by endoscopic Doppler ultrasound (US). The balloon in the draining vein will be inflated and the velocity will be reassessed. Endoscopic puncture of the varices will be done and the embolization will be conducted under balloon-occlusive conditions (Injection of Cyanoacrylate: Lipiodol mixture 1:1 slowly and gradually). Balloon will be kept inflated and a microcatheter will be used through its lumen inside the variceal bed to inject occlusive agent (cyanoacrylate) mixed with Lipiodol.
~At the end of the procedure an occlusion device (plug amplatzer 2) will be placed."
15873649|NCT03853707|Drug|Atezolizumab|Given IV
15873650|NCT03853707|Drug|Capecitabine|Given PO
15873651|NCT03853707|Drug|Carboplatin|Given IV
15873652|NCT03853707|Drug|Ipatasertib|Given PO
15873653|NCT03853707|Drug|Paclitaxel|Given IV
15873654|NCT03853707|Other|Quality-of-Life Assessment|Ancillary studies
15873655|NCT03853707|Other|Questionnaire Administration|Ancillary studies
15873656|NCT03853694|Drug|50 mcg Duramorph+ EXPAREL + multi-modal pain regimen|Intrathecal injection of 50 mcg Duramorph + EXPAREL administered via TAP infiltration + multi-modal pain regimen.
15873657|NCT03853694|Drug|150 mcg Duramorph + multi-modal pain regimen|Intrathecal injection of 150 mcg Duramorph + multi-modal pain regimen.
15873658|NCT03853694|Drug|Exparel TAP + multi-modal pain regimen|EXPAREL administered via TAP infiltration + multi-modal pain regimen.
15873659|NCT03853681|Diagnostic Test|additional blood sampling|additional blood sampling
15873660|NCT03853668|Behavioral|exercise|control group (n=40) did aerobic exercises on treadmill for 10 weeks experimental group (n=40) did combined aerobic and resisted exercises for 10 weeks
15873661|NCT03853655|Radiation|Post-operative adjuvant radiotherapy|"Conventional treatment planning, as well as intensity-modulated radiation therapy (IMRT) planning, would be allowed on the study with patients being stratified on the RT technique.
~Treatment would be delivered on telecobalt unit (gamma-rays/linear accelerator (6MV photons). All fields would be treated daily.
~Phase I: 46 Gray(Gy) in 23 fractions over 4.5 weeks Phase II: 14Gray in 7 fractions over 1.5 weeks
~For IMRT, inverse planning would be done on a commercial TPS configured to deliver IMRT using 6MV photons. Patients shall be treated using the simultaneous integrated boost (SIB) technique with 5 fractions being delivered every week."
15873662|NCT03853642|Other|Blood sampling|Blood sampling, Spirometry, Fraction exhaled Nitric Oxide
15873663|NCT03853629|Other|None. Not applicable|None. Not applicable
15873664|NCT03853616|Biological|MB-CART19.1|MB-CART19.1 consists of autologous CD19 Chimeric Antigen Receptor (CAR) transduced CD4/CD8 enriched T cells targeting CD19-positive tumor cells in b cell malignancies
15873665|NCT03853603|Dietary Supplement|Santa herba|Santa herba dry extract; 400 mg/day. 2 capsules/day; 1 capsule twice daily with the main meals (lunch and dinner)
15873666|NCT03853603|Dietary Supplement|Placebo|Maltodextrin; 400 mg/day. 2 capsules/day; 1 capsule twice daily with the main meals (lunch and dinner)
15873667|NCT03853590|Procedure|Roux-en-Y gastric bypass|Creation of a small pouch from the stomach and connection of the newly created pouch directly to the small intestine so that swallowed food bypasses most of the stomach and the first section of the small intestine.
15873668|NCT03853590|Procedure|Laparoscopic adjustable gastric banding|Placement of a soft silicone ring with an expandable balloon in the center, around the top part of the stomach to create a two-compartment stomach, with a much smaller top part above the band. The subject will eat enough food only to fill the top part of the stomach decreasing caloric consumption.
15873669|NCT03853577|Other|TMS/EEG|navigated TMS/high-density(hd)-EEG to directly stimulate defined cortical areas and investigate quantitatively the level of consciousness in psilocybin-induced altered brain states
15873670|NCT03853564|Behavioral|Video-Feedback Intervention|Mothers and infants of the VFG arm will participate to a 6-session video-feedback intervention structured as follows: 4 sessions of video-review discussions with a trained clinician + 2 sessions of integrative intervention aimed at translating into practical caregiving the insights developed during the video-review discussions.
15873671|NCT03853564|Other|Phone-Call Intervention|Mothers of the PCG arm will participate in 6-session of telephone call during which a trained collaborator will ask details on different domains of infants behavioral development.
15873672|NCT03853551|Drug|Osimertinib|Osimertinib is an oral, potent, selective, irreversible inhibitor of both epidermal growth factor receptor - Tyrosine kinase inhibitors (EGFR-TKI) sensitizing and resistance mutations in nonsmall cell lung cancer (NSCLC) with a significant selectivity margin over wild-type EGFR.
15873673|NCT03853538|Drug|BAY207543 (Bepanthol, Bepantol® Derma Spray)|Product is applied to one hemiface.
15873674|NCT03853538|Other|Semisolid vaseline|Product is applied to one hemiface.
15873675|NCT03853525|Drug|BAY207543 (Bepanthol, Bepantol® Derma Spray)|Product is applied to one side of the inguinal region.
15873676|NCT03853525|Other|Semisolid vaseline|Product is applied to one side of the inguinal region.
15873677|NCT03853512|Drug|BAY207543 (Bepanthol, Bepantol® Derma Spray)|Product is applied to one side of the inguinal region.
15873678|NCT03853512|Other|Semisolid vaseline|Product is applied to the other side of the inguinal region.
15873679|NCT03853499|Other|No intervention (observational study)|No intervention (observational study)
15873680|NCT03853473|Procedure|Remote Ischemic Preconditioning|Remote Ischemic Preconditioning (RIPC) occurs when a limb is made transiently ischemic (5 minutes) using a simple blood pressure cuff. We are proposing that study participants in the RIPC group perform the intervention daily at home for at least 14 days prior to scheduled surgery. They will inflate a blood pressure cuff on the upper portion of their nondominant arm, inflate it to 225 mmHg for 5 minutes, release the cuff for 5 minutes, and repeat this 5 times (for a total of 45 minutes). A study coordinator will monitor compliance with phone calls and daily log sheets that must be filled out.
15873681|NCT03853460|Procedure|epidural catheter|ultrasound low frequency probe will be used to determine the depth of the posterior complex to assists placement of midline thoracic epidural
15873682|NCT03853460|Procedure|nerve block catheter|ultrasound guided placement of bilateral quadratus lumborum catheters
15873823|NCT03852407|Drug|Cyclophosphamid|50 mg/kg on days +3 and +4.
15873683|NCT03853447|Diagnostic Test|Diagnostic imaging|MRI assessments including magnetic resonance cholangiopancreatography (MRCP) and diffusion weighted imaging (DWI) combined with gold standard EUS
15873684|NCT03853434|Procedure|Embolization|Angiographic embolization
15873685|NCT03853421|Drug|Sevuparin|The study will consist of three dose cohorts (3, 6 and 9 mg/kg sevuparin). Subjects in each cohort will receive a single dose of sevuparin or placebo subcutaneously on Day 1.
15873686|NCT03853408|Procedure|Cholecystectomy|Cholecystectomy (removal of the gallbladder) for acute cholecystitis
15873687|NCT03853395|Diagnostic Test|Tests for drug levels and anti-drug antibodies|Measurement of drug levels and anti-drug antibodies will be undertaken using commercially available enzyme-linked immunosorbent assays (ELISAs) and/or radioimmunoassays
15873688|NCT03853382|Behavioral|Cognitive analytic informed brief therapy|"The brief CAT-informed therapy will take place over two sessions. Session one will last around 90 minutes. In session one, we will discuss with the participant their experience of self-harm and begin to support them to make sense of patterns in their self-harming behaviour. This will be done by thinking about the events that come before or follow self-harm, as well as thoughts and emotions associated with self-harm; it will also be done by thinking about ways that the participant relates to him/herself and other people. By the end of the first session, the researcher and the participant will have collaboratively developed a written diagram which shows patterns in the participant's self-harm.
~Session two will involve revisiting the mapping of patterns. The researcher and participant will the collaboratively develop 'exits' or ways to break patterns and cycles of thinking, feeling and behaviour. Both sessions will have structured endings."
15873689|NCT03853369|Drug|Nifekalant hydrochloride|Treatment is not limited. Patients who have used or will use Nifekalant hydrochloride.
15873690|NCT03853356|Device|Orthoss|Orthoss® granules. Orthoss® granules mixed with local bone and pedicle bone marrow aspirate.
15873691|NCT03853343|Dietary Supplement|Seaweed extract|1 capsule 3 times per day
15873692|NCT03853343|Dietary Supplement|Placebo|1 capsule 3 times per day
15873693|NCT03853330|Device|Ultrasound|Ultrasound-guided Thoracic Epidural Analgesia and Erector spinae plane block.
15873694|NCT03853330|Drug|Bupivacaine HCl Inj 0.25%|Bupivacaine HCl Inj 0.25% will be used in both blocks by the same dose of 7.5-12 ml
15873695|NCT03853330|Drug|Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution|infusion of Bupivacaine Hydrochloride, 0.125%-0.9% Injectable Solution at 5-7 ml/h will be used in both blocks and also for breakthrough pain after both blocks as a bolus of 5-10 ml.
15873696|NCT03853317|Biological|Avelumab|For the treatment of adults and pediatric patients 12 years and older with Metastatic Merkel Cell Carcinoma (MCC).
15873697|NCT03853317|Biological|N-803|Recombinant human super agonist interleukin-15 (IL-15) complex
15873698|NCT03853317|Biological|haNK™|haNK™ for Infusion is a human, allogeneic, NK cell line that has been engineered to produce endogenous, intracellularly retained IL-2 and to express CD16, the high-affinity (158V) Fc gamma receptor (FcγRIIIa/CD16a).
15873699|NCT03853304|Other|+ Folic acid|Salt fortified with folic acid
15873700|NCT03853304|Other|+ Vitamin B12|Salt fortified with vitamin B12
15873701|NCT03853304|Other|DFS|Salt fortified with iron and iodine
15873702|NCT03853291|Behavioral|PICT Workbook|The length of PICT and the delivery model will be informed by observational research that has been approved as part of this protocol (the first participant in the observational phase of this work will be enrolled on March 7, 2019). Lacking knowledge from the information gleaned from the observational and field-testing phases of this study we cannot specify with 100% certainty what the intervention will look like. However, it is likely that PICT will consist of 4-5 weekly 30-minute sessions); the expected delivery model will likely include a combination of online (video observation) and telephone coaching.
15873703|NCT03853291|Behavioral|Information Pamphlet|Pamphlet with information about pain and dementia and links to Alzheimer's Association
15873704|NCT03853278|Behavioral|colorectal cancer self-management|The intervention includes a colorectal cancer self-management information booklet, a DVD, two individual skill training and 12 follow-up telephone calls. These are to establish participants' self-management skills and healthy lifestyle, including physical activity and healthy eating fruits and vegetables.
15873705|NCT03853265|Behavioral|Simulated dental office visit|An immersive first-person point of view (POV) video simulation of the dental office in the three-dimensional environment (using a virtual reality headset) which allows participant to look around the room as they move down the hallways which is to be watched/experienced by the participant as often as possible between the initial visit and the follow up visit
15873706|NCT03853252|Other|Skin biopsy|Skin biopsy on a location preliminarily anesthetized Disinfection protocol Combined required blood tests (HIV, Hepatitis B)
15873707|NCT03853239|Procedure|face mask ventilation crossover nasal ventilation|Group A was first ventilated through the face mask, and the tidal volume was measured under pressure-controlled mode (10, 15, 20 cm H2O) ;Switched to volume-controlled (6,8,10ml/kg predicted body weight)mode, the actual tidal volume was recorded, and the air leakage was calculated. Then, put a nasal RAE tube in one side of the nostril, inflate the cuff, make the catheter in a natural position after inflation, clip the other side of the nostril, close the lip with tape, connect the breathing circuit, record the actual tidal volume; measure the expired tidal volume during pressure-controlled ventilation (10, 15, 20 cm H2O).Subject will start with one technique and then cross over to the other technique.
15873708|NCT03853239|Procedure|nasal ventilation crossover face mask ventilation|Group B first placed a nasal RAE tube in one side of the nostril, the cuff was inflated, the catheter was in a natural position after inflation, the other side of the nostril was clamped, the lip was closed with tape, the breathing circuit was connected, and the amount of tidal volume was measured under pressure-controlled mode ( 10,15,20cm H2O) ; switch to volume-controlled ventilation mode (6,8,10ml/kg predicted body weight), record the actual tidal volume; pull out the tracheal tube, perform mask ventilation, record the actual tidal volume and tidal volume under volume-controlled mode(6,8,10ml/kg predicted body weight) and pressure-controlled mode (10, 15, 20 cm H2O) , respectively.Subject will start with one technique and then cross over to the other technique.
15873709|NCT03853226|Procedure|All monitoring|For all patients, data from trans-esophageal Doppler, trans-thoracic echocardiography (TTE) and hemodynamic data are collected at the end of the procedure. During catheter withdrawal, pressure waveforms are recorded at two predefined aortic locations: in the ascending aorta and in the descending thoracic aorta just in front of the esophageal Doppler probe.
15873710|NCT03853213|Behavioral|Cognitive Bias Modification Training|"In task 1, participants view a pair of threat-neutral words and then a single letter (E or F). Participants' task is to tap a button as quickly and accurately as possible to indicate whether they see E or F. The letter appears in the neutral location on 90.6% of trials, thereby reinforcing participants' attending away from threat. In task 2, participants view a word or phrase corresponding to a threatening (e.g., dying) or benign (e.g., sleep) interpretation of a sentence (e.g., You have been waking up tired recently). They are asked to tap a button to indicate whether the word or phrase was related to the sentence. Positive feedback (Correct) is given for rejected threat interpretations and for benign interpretations. Otherwise, negative feedback (Incorrect) is given."
15873711|NCT03853213|Behavioral|Attention Control Training|In task 1, participants view a pair of threat-neutral words and then a single letter (E or F). Participants' task is to tap a button as quickly and accurately as possible to indicate whether they see E or F. The target letter is equally likely to appear in the threat location as the neutral location. Thus, participants' patterns of attention are not trained toward or away from threat. In task 2, participants view a word or short phrase corresponding to either a threatening or benign interpretation of a sentence that follows it. They are asked to tap a button to indicate whether the word or phrase was related to the sentence. Positive feedback and negative feedback are equally likely to be given regardless of whether participants endorse the threatening or benign interpretations.
15873712|NCT03853200|Drug|QMix Root Canal Irrigant|Endodontic irrigant recommended for final irrigation
15873713|NCT03853200|Drug|17%EDTA+2%Chlorhexidine|two endodontic irrigants will be used in this group in a sequential manner
15873714|NCT03853200|Other|EDTA|17% EDTA irrigation solution
15873717|NCT03853174|Other|Endurance Training ET|Endurance training were prformed. Intensity was gradually increased.
15873718|NCT03853174|Other|Resistance Training RT|Resistance training were prformed. Intensity was gradually increased.
15873719|NCT03853161|Other|Vapotherm|A form of non invasive ventilation used in newborns
15873720|NCT03853161|Other|NIPPV|A form of non invasive ventilation used in newborns
15873721|NCT03853148|Behavioral|Otago|Exercise program for strength and balance
15873722|NCT03853148|Behavioral|Gentle yogic breathing|yogic breathing
15873723|NCT03853148|Behavioral|Behavioral Activation|Behavioral Activation incorporates daily planners and worksheets to identify and rate reinforcing behaviors and is often used in conjunction with other interventions because components of these interventions are easily incorporated into the daily planner based activities.
15873724|NCT03853148|Behavioral|Caregiver Gentle yogic breathing|yogic breathing
15873725|NCT03853135|Diagnostic Test|measurement of serum endocan|measurement of serum levels of endocan
15873726|NCT03853122|Other|Best current practice exercise programme|"Therapeutic Physical Exercise programme based on the protocol of Afredson (for Achilles and patellar tendinopathies) and LEAP (for gluteal tendinopathy).
~Achilles tendinopathy: ALFREDSON ECCENTRIC PROTOCOL: 3 sets of 15 repetitions of two eccentric exercises
~Patellar tendinopathy: ALFREDSON ECCENTRIC PROTOCOL: 3 sets of 15 repetions of one eccentric exercise
~Gluteal Tendinopathy: EXERCISE LEAP PROTOCOL: an exercise programme divided into stages with progression in different exercises, volumes and loads"
15873727|NCT03853122|Other|Experimental exercise programme|Therapeutic Physical Exercise programme structured in five stages oriented to specific neuromuscular adaptations based on the characteristics of the neuromuscular system, once daily, three times/week, sets, repetitions and load based on individually performed tests.
15873729|NCT03853096|Drug|Cefazolin|Cefazolin 100mg/mL, 3mL in three locations will be administered around a surgical incision on the anterior shoulder in a standard deltopectoral approach interval. This will be a one time administration. Administration and route will be subcutaneous.
15873730|NCT03853083|Device|Hypoxi Equipment|Using the Hypoxi exercise equipment to try and improve lipedema fat tissue
15873731|NCT03853083|Device|Recumbent Bicycle|Recumbent bike is a piece of exercise equipment used as the comparison group
15873732|NCT03853070|Device|ED Coil / Electro-detach Generator v4|The ED Coil is used for vascular embolization with a platinum coil at the target lesion in a patient's blood vessel. The ED Detach Generator is intended to for use solely to detach the platinum coil from the delivery catheter of the ED Coil.
15873733|NCT03853057|Other|body positions|positive pressure ventilation at different body positions
15873734|NCT03853044|Drug|Chidamide|Chidamide 20mg per day administered orally on Day 1, 4, 8, 11 of each 21-day cycle for 6 cycles
15873735|NCT03853044|Drug|Cyclophosphamide|Cyclophosphamide 750 milligrams per square metre (mg/m^2), administered intravenously (IV) on Day 1 of each 21-day cycle.
15873736|NCT03853044|Drug|Doxorubicin|Doxorubicin 50 mg/m^2 IV, administered on Day 1 of each 21-day cycle.
15873737|NCT03853044|Drug|Vincristine|Vincristine 1.4 mg/m^2 (maximum 2 mg) IV, administered on Day 1 of each 21-day cycle.
15873738|NCT03853044|Drug|Prednisone|Prednisone 60mg/m2 , Maximum 100 mg , (or equivalent prednisolone or methylprednisolone), administered orally on Days 1-5 of each 21-day cycle.
15873739|NCT03853031|Procedure|LVEDA cm2 guided intraoperative fluid in TEE /Study Group|Placement of Transoesophageal echocardiography probe in TEE group to measure Left ventricular end diastolic area cm2
15873740|NCT03853031|Procedure|CVP guided intraoperative fluid in CVP / Control group|Ultrasound guided Internal Jugular Vein catheter placement in CVP group to measure CVP value cms H2O .
15873741|NCT03853018|Device|CWAT intervention|Participant in the intervention group will wear an activity tracker for 12 weeks.
15873742|NCT03853018|Device|CWAT + motivation intervention group|Participant in the intervention group will wear an activity tracker for 12 weeks and are also motivated by the researcher via a lifestyle data platform.
15873949|NCT03851341|Combination Product|Janumet XR tablet 100/1000 mg|To administrate the Janumet XR tablet
15888387|NCT03740165|Drug|Placebo for olaparib|Oral tablet
15873743|NCT03853005|Other|HVHDF|Patients will receive HVHDF treatment for at least 48 hours. HVHDF will be performed via indwelling central venous catheter. The blood flow will be 180-240 ml/min, and ultrafiltration rate will be 35-50 ml/kg/h during HVHF. The substitute fluid will be infused with pre-dilution. Heparin will be used for anti-coagulation, whose initial dose will be 15-25 U/kg, and maintenance dose is 5-15 U/kg/h. aPTT time maintained between 60-80 second and will be checked every 12 hours.
15873744|NCT03853005|Other|controlled|supportive care
15873745|NCT03852992|Drug|Post-Laser Minoxidil 2%|2ml of 20mg/ml sterile solution, applied post-laser procedure
15873746|NCT03852992|Drug|At-Home Minoxidil 5%|2ml of 50mg/ml foam q24 h for duration of study
15873747|NCT03852992|Device|Laser|Fractional ablative, deep mode, 5% fractional coverage
15873748|NCT03852992|Drug|Post-laser 5mg minoxidil|0.25ml of 20mg/ml sterile solution, applied post-laser procedure
15873749|NCT03852992|Drug|Post-laser 10mg minoxidil|0.5ml of 20mg/ml sterile solution, applied post-laser procedure
15873750|NCT03852992|Drug|Post-laser 20mg minoxidil|1ml of 20mg/ml sterile solution, applied post-laser procedure
15873751|NCT03852979|Drug|Paclitaxel|weekly paclitaxel 80 mg/m2 for 12 weeks
15873752|NCT03852979|Drug|Carboplatin|weekly carboplatin AUC=2 for 12 weeks
15873753|NCT03852979|Procedure|conisation|if tumor is reduced to <2 cm, patients will be treated with a conisation
15873754|NCT03852966|Behavioral|CBT-i/ADHD|Cognitive Behavioral Therapy for insomnia adjusted for patients with ADHD
15873755|NCT03852953|Other|Under- or overdiagnosed cancer|Diagnosed with a cancer that was visible on prior mammograms
15873756|NCT03852953|Other|Screening|Invited or attended BreastScreen Norway
15873757|NCT03852940|Other|Parenteral nutrition|
15873758|NCT03852940|Other|Enteral Nutrition|
15873759|NCT03852927|Procedure|Computer guided contouring|Using virtual planing and rapid prototyping a surgical guide will be fabricated, and will be used for bone contouring of the bone lesion.
15873760|NCT03852914|Device|Sodium hyaluronate 2%|Each patient will receive a single injection of SH 2% and will be followed for 6 months. At 6 months follow up visit patients could be offered a second injection whenever and when they comply with the criteria established for re-treatment and will be followed for additional 6 months.
15873761|NCT03852901|Drug|Jardiance 25 mg|This study involves a screening visit (Visit 0) and 3 study visits (Visits 1, 2 and 3) to the NIA Clinical Unit. In this pilot study, each enrolled participant will have a baseline visit (Visit 1)where no medication will be given and frequent blood draws for 34 hours
15873762|NCT03852888|Biological|Urine samples taken to measure methotrexate and its major metabolite 7-OH-methotrexate level|Each patient will have to complete a total of 8 urine samples after treatment with methotrexate. The 8 samples will be taken over one week (just before taking, then 2 hours after taking treatment and then on D3, D4, D5, D6, D7, D8 before the new dose of methotrexate).
15873763|NCT03852875|Other|Education|Same
15873764|NCT03852875|Other|Control|Same
15873765|NCT03852862|Drug|Serratus plane block and paravertebral block|Single Administration of 20 mL of ropivacaine for Serratus plane block (Intra-muscular injection) followed by a single administration of 20 ml ropivacaine for paravertebral block (T4 inter-vertebral injection)
15873766|NCT03852862|Drug|paravertebral block|Single Administration of 20 ml of ropivacaine for paravertebral block (T4 inter-vertebral injection)
15873767|NCT03852849|Behavioral|Personal involved intervention strategies|Medical institutions will provide personal involved intervention strategies for patients which guided by viral load testing monthly until viral load drop below the detection limit.
15873768|NCT03852849|Drug|The dosage of 400mg EFV|The dosage of 400mg EFV will be used in the antiviral therapy.
15873769|NCT03852836|Other|ultra-rapid acquisition of bile ducts images|On top of the conventional SPACE sequence, 2 supplementary sequences will be performed with the ultra-rapid sequence (sequence CS-SPACE) either acquired in apnoea or synchronized with the breath.
15873770|NCT03852823|Drug|SG001|Phase Ia: Subjects will receive intravenous infusion of SG001 following a sequential dose escalation design (1mg/kg, 3mg/kg and 10mg/kg). Dose limited toxicity (DLT) will be observed within 21 days after the first administration, then subjects can continuously receive SG001 every 2 weeks until confirmed progression, unacceptable toxicity, or withdrawal from the trial. Phase Ib: Subjects will receive intravenous infusion of SG001 at the dose of 240 mg every 2 weeks until confirmed progression, unacceptable toxicity, or withdrawal from the trial.
15873771|NCT03852797|Drug|Oxytocin|Oxytocin solution, 20nM concentration
15873772|NCT03852797|Drug|Ketamine|Ketamine in solution, 10-4M to 10-7M
15873773|NCT03852797|Drug|Propofol|Propofol in solution, 10-4M to 10-7M
15873774|NCT03852797|Drug|Etomidate|Etomidate in solution, 10-4M to 10-7M
15873775|NCT03852784|Other|Bone and joint infection with Streptococcus peumoniae|description of the osteoarticular infection with Streptococcus peumoniae
15873776|NCT03852771|Device|Cirvo(TM) therapy|The Cirvo(TM) (also referred to as the Radial Medical Compression System) is a mobile wearable medical device that applies graded intermittent mechanical sequential compression to the lower leg.
15873777|NCT03852758|Behavioral|Outdoor Exercise|2 outdoor exercise sessions per week
15873778|NCT03852758|Behavioral|Indoor Exercise|2 indoor exercise sessions per week
15873779|NCT03852745|Behavioral|Cognitive Behavioral Therapy|cognitive behavioral therapy; focus on learning skills including acceptance and commitment
15873780|NCT03852732|Device|PoNS Treatment|"PoNS Treatment will consist of three stages: an in-clinic training program, a home training program, and an extended home training program. During all stages of the study, subjects will complete three training sessions per day, morning, afternoon and evening, 6 days per week.
~Daily Training Program: The same daily training program will be performed during all stages with the exception of the morning BAT session, which is not performed during stage 2 or 3:
~Morning:
~Warm Up Exercises without the PoNS Balance Training with PoNS Gait Training with PoNS Breathing and Awareness Training (BAT) with PoNS 3- to 4-hour break between morning and afternoon sessions
~Afternoon:
~Balance Training with PoNS Movement Control Training without PoNS Gait Training with PoNS
~Evening:
~Breathing and Awareness Training with PoNS To be performed at home during all stages"
15873782|NCT03852706|Other|LORETA|Twenty sessions of neurofeedback training using LORETA in combination with z-scores.
15873783|NCT03852706|Other|Treatment as usual|Treatment-as-usual
15873785|NCT03852680|Procedure|aneurysm clipping|treatment of wide necked intracranial aneurysms using different modalities as open surgery by clipping or endovascular techniques as coiling and flow diversion
15873786|NCT03852667|Behavioral|Pain Neuroscience Education|The PNE intervention consisted of 2 sessions of 30 minutes. In the first session, the main goal is to explain the patient why pain is important and why people can't live without it. Besides it is explained why objective findings such as x-rays, MRI, CT scans, etc. often lack significant findings despite the pain that the patient experiences. This first session of pain education might help the patient understand that pain is necessarily a result from tissue damage. Furthermore, the session explains the right approach to conquer pain and to avoid going down in this vicious circle of low back pain. The second session of PNE, is a revision of the first session, continuing on what was unclear from the first session.
15873787|NCT03852667|Other|Exercise therapy|The exercise therapy varies form analytical exercises in the first sessions, to functional and sports related exercises near the following sessions. The first session focuses on the lumbar neuromuscular control of the patients: first a voluntary contraction of the Transversus Abdominis muscle, the Multifidus muscle and the pelvic floor muscles is learned. When the subject is able to maintain the combined contraction for 10 times, the exercises evolve to more complicated tasks. In the final stage, more functional and sport specific tasks will be exercised.
15873788|NCT03852654|Drug|18F-DCFPyL|"Subjects with biopsy proven prostate cancer, no prior local therapy, and:
~PSA ≥ 10 ng/dl, or Gleason Sum ≥ 4+3, or clinical stage ≥cT2c Staging by 99mTc-MDP or NaF PET bone scan, and Diagnostic CT (pelvis) or MRI will undergo 18F DCFPyL PET CT scan."
15873789|NCT03852641|Other|Length of feeding|Feeds will be given via nasogastric tube over 15-30 min versus 2 hr
15873790|NCT03852628|Drug|2mg Buprenex and 380mg Vivitrol|Daily 2mg SL BUP (84 pills total, taken sublingual every day for 12 weeks) and Q4wks (given intramuscular, 3 injections total: at baseline, week4 and week8 ) IM NLTRX
15873791|NCT03852628|Drug|Placebo (SL pill qd, IM injection q4weeks)|Daily SL placebo (84 pills total, taken sublingual every day for 12 weeks) and Q4wks (given intramuscular, 3 injections total: at baseline, week4 and week8) IM Placebo
15873792|NCT03852615|Diagnostic Test|Pre operation Blood sample for AMH|Blood sample for Anti Mullarian Hormone (AMH) analysis will be taken during preparation for surgery, while inserting vein line and taking the customary blood samples.
15873793|NCT03852615|Diagnostic Test|3 month post operation blood sample for AMH|Additional blood sampling that will include a single tube containing 3 cc of blood for analysis of AMH will be taken three month from operation.
15873794|NCT03852602|Drug|Preemptive Analgesics|Analgesic application15 minutes before the treatment
15873795|NCT03852602|Drug|Control|Analgesic application15 minutes before the end of the treatment
15873796|NCT03852589|Device|C-MAC videolaryngoscope|An intubating device that is used for endotracheal intubation. PLMA will inserted by anesthesiologist with C-MAC videolaryngoscope.
15873797|NCT03852589|Device|Blind|PLMA will inserted by anesthesiologist with digital finger.
15873798|NCT03852576|Drug|KSP/QRH dimer|KSP-QRH-E3-IRDye800 (Peptide 919288G)
15873799|NCT03852563|Drug|BAY207543 (Bepanthol)|Product is applied to one hemiface.
15873800|NCT03852563|Other|Semisolid vaseline|Product is applied to one hemiface.
15873801|NCT03852550|Other|e-health application|In the first part of this study, an e-health application (MyREADY Transition[TM] BBD App) was developed, targeting the needs of youth with BBD during their transition and transfer from pediatric to adult health care. Program development centered on three core foci of health care transition planning: education, empowerment, and navigation. The intervention has an emphasis on the process of transition in which youth and young adults learn information and develop skills in order to eventually assume maximal responsibility for self-management of their conditions (e.g., learning how to speak directly with health providers) while also providing information to prepare youth for the event of the transfer from pediatric to adult health care.
15873802|NCT03852537|Drug|Methylprednisolone|Methylprednisolone will be administered based on CRP-guided protocol outlined under 'Biomarker-adjusted steroid dosing'.
15873803|NCT03852537|Other|Usual Care|Usual care as determined by the patients treatment team.
15873806|NCT03852511|Biological|NG-350A|NG-350A is oncolytic adenoviral vector which expresses a full length agonist anti-CD40 antibody at the site of virus replication.
15873807|NCT03852498|Genetic|Lenti-D|Lenti-D Drug Product (autologous CD34+ cell-enriched population that contains cells transduced with Lenti-D lentiviral vector that encodes an ABCD1 complementary deoxyribonucleic acid complementary DNA (cDNA) for human adrenoleukodystrophy protein, suspended in a cryopreservation solution) is administered intravenously. Lenti-D Drug Product is administered by IV infusion following myeloablative conditioning with busulfan and fludarabine.
15873808|NCT03852485|Device|SD-OCT|Spectral Domain Optical Coherence Tomography for non-invasive, light-based, cross-sectional imaging of ocular structures
15873809|NCT03852472|Drug|Avacopan|Active treatment
15873810|NCT03852472|Other|Placebo|Placebo
15873811|NCT03852459|Drug|S-Ibuprofen|Topical Gel 5%
15873812|NCT03852459|Drug|Vehicle|Vehicle Gel
15873813|NCT03852446|Drug|Indoximod HCL (F2) tablets|The doses will be ascending per cohort from 600 mg to 2400 mg
15873814|NCT03852446|Drug|Indoximod base formulation|Single oral administration of 1200 mg
15873815|NCT03852446|Other|Placebo|The matching placebo doses will be ascending per cohort from 1 to 4 tablets
15873816|NCT03852446|Drug|Indoximod HCL (F2) tablets|Single oral administration of 1200 mg
15873817|NCT03852433|Drug|Bulevirtide|daily subcutaneus injections
15873818|NCT03852433|Drug|Peginterferon Alfa-2a|weekly subcutaneus injections at a dose 180 mcg
15873819|NCT03852420|Device|LUMINIZE RF Balloon Catheter|Ablation Therapy with the LUMINIZE RF Balloon Catheter
15873820|NCT03852407|Drug|Thymoglobulin|ATG: 2.5 mg /kg/day on day -2 and -1 (day 0 is allogenic transplantation)
15873821|NCT03852407|Drug|Melphalan|100mg/m² on day -2
15873822|NCT03852407|Drug|Fludarabine|30mg/m² on days -6, -5, -4, -3, and -2
15873824|NCT03852394|Other|Respiratory mechanics assessment|The study protocol consisted of two consecutive phases; in the first step measurements of static respiratory mechanics and end expiratory lung volume (EELV) were performed after 30 minutes of MV in volume control mode. In the second step transdiaphragmatic pressure (Pdi) was calculated by means of a sniff maneuver (Maximal Pdi) after 30 minutes of spontaneous breathing trial. Linear regression analysis and Pearson's correlation coefficient was used to asses the association between Maximal Pdi values and static and dynamic mechanical features and the association between Maximal Pdi and Pdi/Maximal Pdi.
15873825|NCT03852381|Device|Spinal Cord Stimulation|Paresthesia-based SCS(PB-SCS), with stimulating frequencies between 30 to 80 Hz that confer a tingling sensation. Three different paresthesia-free SCS (PF-SCS) modes that use frequencies in the range of 400-10,000 Hz include Burst, High Frequency stimulation at 1.2 kHz and High Density stimulation at 400 Hz.
15873826|NCT03852368|Other|Exercise|The effects of exercise with different intensity on the executive functions of adolescents
15873827|NCT03852355|Drug|Radiofrequency|), received bilateral 3rd occipital nerve RF under fluoroscopic guidance. Levobupivacaine (0.3 mL; 0.75%) and triamcilonone (1 mg) were injected at each level
15873828|NCT03852355|Drug|Steroids|received systemic steroids oral prednisolone tablet, 10 mg/day
15873829|NCT03852329|Device|Lateral skull base navigation|"Patient preparation: The participant is prepared for the surgery according to clinical standards.
~System setup: The hardware components of the investigational device are set up
~Tripod fixation: The tripod with integrated registration fiducials is fixed on the participant's skull.
~CBCT imaging: A CBCT image of the participant is acquired
~Image processing: The CBCT data is loaded on the navigation platform. The registration fiducials are automatically detected in the image data and relevant anatomy is segmented using an otologic planning software.
~Measurements: The navigation software is started, and the fiducial positions and segmentations loaded. The measurements are conducted.
~Treatment: The surgery is conducted by the surgeon according to clinical standards"
15873830|NCT03852316|Device|Click Device|A single-use device containing a polymerase chain reaction (PCR)-based nucleic acid amplification test (NAAT) for detection of deoxyribonucleic acid (DNA) from Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) in self-collected vaginal specimens.
15873831|NCT03852303|Drug|ivermectin|evaluate effect of ivermectin on frequency of seizures
15873832|NCT03852264|Behavioral|Pet dog|Children will interact freely with their pet dog for 25 minutes.
15873833|NCT03852264|Behavioral|Unfamiliar dog|Children will interact freely with an unfamiliar dog for 25 minutes
15873834|NCT03852264|Behavioral|Nonsocial control|Children will play with age-appropriate toys/games for 25 minutes.
15873835|NCT03852251|Biological|AK104|Subjects will receive AK104 by intravenous administration.
15873836|NCT03852251|Drug|Oxaliplatin|Subjects will receive AK104 in combination with oxaliplatin and capecitabine.
15873837|NCT03852251|Drug|Capecitabine|Subjects will receive AK104 in combination with oxaliplatin and capecitabine.
15873838|NCT03852238|Other|Blood test and self-administrated questionnaires|
15873839|NCT03852225|Diagnostic Test|Intra-arrest echocardiography|Intra-arrest echocardiography performed by portable ultrasound device during ongoing chest compressions.
15873840|NCT03852212|Other|Manipulation|Thrust technique application
15873841|NCT03852199|Other|Test protocol for proprioceptive force sense in case group|"The FS in the knee region was measured by the pressure, biofeedback device (Stabilizer ™, Chattanooga Group Inc., Chattanooga, TN).
~Surface EMG device (Noraxon USA, Inc., Scottsdale, AZ) was used to measure activation levels of M. Vastus Medialis Obliquus (VMO), M. Vastus Lateralis (VL) and M. Rectus Femoris (RF) muscles. Due to the characteristics of the Bipolar Ag/AgCl surface electrodes, the distance between the electrodes was set to 1 cm and the electrode width to 2 cm. The electrode placement was determined according to the SENIAM (Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles) criteria."
15873842|NCT03852186|Behavioral|Cognitive behavioral therapy|Group based psychotherapy
15873843|NCT03852186|Behavioral|Acceptance and commitment therapy|Group based psychotherapy
15873844|NCT03852173|Behavioral|Wasserschulen|"Schools receive following materials and trainings:
~one training sessions for teachers (at the beginning of the intervention)
~refillable water bottles for each school student
~drying rack for water bottles for each classroom
~educational material for each class and for school events
~informational material for parents"
15873845|NCT03852160|Drug|Esketamine 28 mg|Participants will receive 28 mg esketamine as nasal spray (Initial dose for elderly participants with 65-74 years of age on Day 1 and then uptitrated to 56 mg on Day 4).
15873846|NCT03852160|Drug|Esketamine 56 mg|Participants will receive 56 mg esketamine as nasal spray (Initial dose for participants with 18-64 years of age) on Day 1. The dose may be increased/may remain same based on the efficacy and tolerability. Participants with 65 to 74 years of age will receive esketamine 56 mg from Day 4 onwards.
15873847|NCT03852160|Drug|Esketamine 84 mg|Participants may receive 84 mg (maximum uptitrated esketamine dose). The dose may be decreased/may remain same based on the efficacy and tolerability.
15873848|NCT03852160|Drug|Placebo|Participants will receive matching placebo as nasal spray.
15873849|NCT03852160|Drug|Escitalopram|Escitalopram can be selected as the oral antidepressant medication based on investigator's discretion. The initial dose for escitalopram is 5 mg once daily (for elderly participants) and 10 mg once daily (for adults). The dose may be increased to 10 mg (for elderly participants) and 20 mg (for adults) once daily at the discretion of treating physician/investigator.
15873850|NCT03852160|Drug|Sertraline|Sertraline can be selected as the oral antidepressant medication based on investigator's discretion. The initial dose for sertraline is 50 mg once daily and may be increased up to 200 mg once daily.
15873851|NCT03852160|Drug|Duloxetine|Duloxetine can be selected as the oral antidepressant medication based on investigator's discretion. The initial dose for duloxetine is 60 mg once daily and may be increased to 120 mg once daily.
15873852|NCT03852160|Drug|Mirtazapine|Mirtazapine can be selected as the oral antidepressant medication based on investigator's discretion. The initial dose for mirtazapine is 15 to 30 mg once daily and may be increased to 45 mg once daily.
15873853|NCT03852160|Drug|Agomelatine|Agomelatine can be selected as the oral antidepressant medication based on investigator's discretion. The initial dose for agomelatine is 25 mg once daily and may be increased to 50 mg once daily after 2 weeks.
15873950|NCT03851341|Combination Product|GLH1SM tablet 100/1000 mg|To administrate the GLH1SM tablet
15873854|NCT03852160|Drug|Bupropion|Bupropion can be selected as the oral antidepressant medication based on investigator's discretion. The initial dose for bupropion is 150 mg once daily and may be increased to 300 mg once daily after 4 weeks.
15873855|NCT03852160|Drug|Trazodone Prolonged Release|Trazodone prolonged release can be selected as the oral antidepressant medication based on investigator's discretion. The initial dose for trazodone prolonged release is 75 to 150 mg once or twice daily and may be increased up to 450 mg (adults) and 300 mg (elderly).
15873856|NCT03852147|Procedure|: hemodynamic management|"Control group: hemodynamic management of patients is done according to usual practices by maintenance of blood pressure by norepinephrine as well as optimization of SV by vascular filling and use of dobutamine if necessary.
~Experimental group: perioperative hemodynamic management is based on an algorithm that includes RQ measurement and includes volume expansion, norepinephrine, FiO2 enhancement, RBC transfusion and dobutamine."
15873857|NCT03852134|Procedure|MOCC Group|After 30 seconds of DCC, the cord will be clamped and cut 5 cm from the introitus in vaginal delivery or abdominal incision in the case of cesarean section before passing the infant with the long umbilical cord segment to the pediatric provider who will milk the cord one time towards the baby during resuscitation.
15873858|NCT03852134|Procedure|DCC Group|"The OB provider will hold the baby at or below the level of placenta, provide warmth, stimulate the baby to breathe and suction the mouth/nose if needed for the first 30 seconds.
~After these initial 30 seconds, if the baby is breathing then the obstetrician will continue DCC for a total of 60 seconds before clamping and cutting the cord close to the umbilicus and handing over the baby to the neonatal team for further stabilization as per standard NRP practice. If the baby is not breathing after the initial 30 seconds of DCC, then the OB provider will clamp and cut the cord close to the umbilicus and hand over the baby to the neonatal team to continue resuscitation of the baby as per the standard NRP guidelines."
15873859|NCT03852121|Behavioral|Bibliotherapy|"Bibliotherapy is the use of reading materials for therapeutic benefits. In this study, an evidence-based modified manual will be used as the reading material. The manual adopts the self-directed problem-solving approach to dementia caregiving, examples of how other caregivers solve the specific problem for each chapter is included in the corresponding chapter. Bibliotherapy also involves guided learning by reading written information, enabling caregivers to solve their caregiving problems step-by-step, so telephone coach is designed to figure out participants understanding, find out the unsolved problems and guide them for finding out the solution by themselves."
15873860|NCT03852108|Other|Comfort Care|Face, Hand and body care for 15 to 45 minutes
15873861|NCT03852095|Other|minor trauma|following the management of the patient's fracture in the emergency department, the patients / parents are recalled 2 months (J60) after the visit to the emergency room, and are interviewed by following the pre-established interrogation form, which checks the good agreement of the patient. treatment performed with the given sheet and recommendations, and assesses the satisfaction.
15873862|NCT03852082|Procedure|percutaneous coronary intervention|Patients with coronary heart disease co-morbid depression post percutaneous coronary intervention.
15873863|NCT03852069|Dietary Supplement|Inulin|Patient receive inulin as dietary supplement (16g/d) in combination with dietary advice to restrict caloric intake and to enhance the consumption of inulin-rich vegetables
15873864|NCT03852069|Dietary Supplement|Placebo|Patient receive maltodextrin as dietary supplement (16g/d) in combination with dietary advice to restrict caloric intake and to enhance the consumption of vegetables poor in inulin
15873865|NCT03852056|Drug|MFP Fluoride toothpaste|Whole mouth brushing with a toothpaste, 2 times/day for 1 minute each time for the duration of the study,
15873866|NCT03852056|Drug|Stannous fluoride toothpaste|Whole mouth brushing with a toothpaste, 2 times/day for 1 minute each time for the duration of the study,
15873867|NCT03852043|Behavioral|High-intensity interval training|The intervals of high intensity are conducted between 90 and 95 % of heart rate maximum (HRmax) and resting between 50 and 60 % of the HRmax 15 loads of 30 seconds at high intensity, with 60 seconds of recovery at loads of moderate intensity.
15873868|NCT03852043|Behavioral|Moderate-intensity continuous training|The continuous training will be carried out at an intensity between 65 and 75% of the HRmax.
15873869|NCT03852030|Behavioral|Text or email message|Text or email messages sent to research participants
15873870|NCT03852017|Behavioral|Audio Program|
15873871|NCT03852004|Other|ostheopathy|standardized osteopathic treatment
15873872|NCT03852004|Other|simulated osteopathic treatment|standardized simulated osteopathic treatment
15873873|NCT03851991|Drug|Arbidol|oral
15873874|NCT03851991|Drug|Placebos|controle
15873875|NCT03851978|Behavioral|Pharmacist Vaccine Education|When an eligible patient presents to the pharmacy for prescription pick up or drop off, the pop-up note will notify the technician to get a pharmacist for education. The pharmacist will educate the patient on the vaccine and then recommend that the patient receives the vaccine.
15873876|NCT03851965|Diagnostic Test|Soluble Urokinase Plasminogen Activator Receptor|Preoperative and postoperative determination of the Soluble Urokinase Plasminogen Activator Receptor levels in patients undergoing non-cardiac major surgery.
15873877|NCT03851952|Device|Optilume Drug Coated Balloon|The Optilume Drug Coated Balloon (DCB) is a guidewire compatible catheter with a tapered atraumatic tip. The distal end of the catheter has an inflatable balloon coated with a proprietary coating containing the drug paclitaxel that facilitates the drug's transfer to the urethral wall upon inflation.
15873878|NCT03851939|Combination Product|Transarterial Chemoinfusion (TAI) Combine Toripalimab|Transarterial Chemoinfusion (TAI) Combine Toripalimab
15873879|NCT03851926|Radiation|Hypofractionated volumetric radiotherapy in 20 fractions|Hypofractionated radiotherapy at 3 Gy per fraction for localized prostate cancer.
15873880|NCT03851913|Procedure|TAI|transarterial chemoinfusion with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
15873881|NCT03851900|Other|Teethmate Desensitizer (TM)|Desensitizing agent will be applied to sensitive teeth.
15873882|NCT03851900|Other|Clearfil SE Bond 2|Desensitizing agent will be applied to sensitive teeth.
15873883|NCT03851900|Other|Distilled water|Placebo will be applied to sensitive teeth as a negative control.
15873884|NCT03851887|Combination Product|TAI combine SBRT|TAI combine SBRT
15873885|NCT03851874|Procedure|Bariatric surgery|Bariatric surgery
15874024|NCT03850717|Device|acupuncture|insert in filiform needles into skin and other soft tissue to treat the illness or disorders
15873886|NCT03851861|Other|Mediterranean Diet|"Participants will be instructed to include the following in their diet: a) abundant use of olive oil for cooking and dressing dishes; b) consumption of ≥2 daily servings of vegetables; c) ≥2-3 daily serving of fresh fruits (including natural juices); d) ≥3 weekly servings of legumes; e) ≥3 weekly servings of fish or seafood (at least one serving of fatty fish); f) ≥3 weekly serving of nuts or seeds; g) select white instead of red meats or processed meats (burgers, sausages); h) cook at least twice a week with a tomato herb sauce.
~Participants will be instructed to eliminate or limit the consumption of the following foods: cream, butter, margarine, cold meat, paté, duck, carbonated and/or sugared beverages, pastries, industrial bakery products and desserts, French fries or potato chips, and out-of-home pre-cooked cakes and sweets. For usual drinkers, the main source of alcohol should be wine."
15873887|NCT03851848|Other|Joint mobilization (JM)|Joint mobilization (JM) is a manual therapy to move the joint in a desired direction. It is commonly used for improving the joints' ROM and pain intensity, and to overcome joint restriction.
15873888|NCT03851848|Other|Myofascial release (MFR)|Myofascial release (MFR) is a technique in which a slow, sustained pressure is applied to the restricted soft tissue in order to restore optimal length, reduce pain and improve function.
15873889|NCT03851835|Drug|Ondansetron Oral Solution|Six doses of oral ondansetron (0.15mg/kg) to be administered q8h (every 8 hours) to a maximum of 3 times in a 24 hour period, are provided to the participant/caregiver for use after emergency department disposition (i.e. home use).
15873890|NCT03851835|Drug|Oral Placebo|Six doses of oral placebo (0.15mg/kg) to be administered q8h (every 8 hours) to a maximum of 3 times in a 24 hour period, are provided to the participant/caregiver for use after emergency department disposition (i.e. home use).
15873891|NCT03851809|Drug|Wendan decoction combination in acute brain injury|In the intervention group, traditional Chinese medicine was given between 14 days of onset and TCM was used 1 month at least in intervention group.
15873894|NCT03851783|Device|Solar-powered oxygen|Constant and reliable administration of oxygen, using solar panels to power an oxygen concentrator and deliver medical grade oxygen at 1-5L/min.
15873895|NCT03851770|Other|Characterization of Vagus nerve stimulation|Characterization of Vagus nerve stimulation induced larynx evoked motor potential. Patients participating in the study will be asked to come to perform the experiment (duration maximum 1 hour) at the Neurophysiology Department of Saint Luc .
15873896|NCT03851757|Device|waist-shaped interdental brush|use four times each per interdental space
15873897|NCT03851757|Device|cylindric interdental brush|use four times each per interdental space
15873898|NCT03851744|Other|Sea Level|Carbohydrate consumed at 1.8 g/min during treadmill exercise at SL
15873899|NCT03851744|Other|High Altitude|Carbohydrate consumed at 1.8 g/min during treadmill exercise at HA
15873900|NCT03851731|Drug|Naltrexone|Intranasal spray
15873901|NCT03851731|Drug|Naloxone|Intranasal spray
15873902|NCT03851731|Drug|Naltrexol|Intranasal spray
15873903|NCT03851718|Device|Acupuncture Procedure|Each session will run about 30~40 minutes at the Family Medicine Clinic and performed by a licensed acupuncturist. The expense of all three sessions will be reimbursed by the project, not billed to the participant. The following points CV17, ST18 (bilateral), ST36 (bilateral), SI1(bilateral) and LR3(bilateral) , adopted from TCM classic text and previous studies done in China, will be used for all three sessions .
15873904|NCT03851718|Behavioral|Power pumping|It suggests the mom to set at least one hour and two hours preferably for the power pumping at least three days within a 5 weekday period, preferably on 3 consecutive days. During this one hour, the moms will be advised to pump for 20 minutes, rest for 10 minutes, pump for 10 minutes, then rest for 10 minutes and pump for 10 minutes. Alternatively they can also opt to pump and rest for every 10 minutes during the hour.
15873905|NCT03851705|Drug|Inclisiran for injection|Inclisiran is a synthetic, chemically modified small interfering ribonucleic acid (siRNA) targeting proprotein convertase subtilisin kexin type 9 (PCSK9) messenger ribonucleic acid (mRNA) with a covalently attached triantennary N-acetylgalactosamine (GalNAc) ligand. Inclisiran sodium 300mg equivalent to 284mg of inclisiran
15873906|NCT03851705|Drug|Placebo|Sterile normal saline (0.9% sodium chloride in water for injection)
15873907|NCT03851692|Other|Intravenous Cannulation (iv placement)|The aim of our study is to determine whether one should make intravenous attempts placement during the early induction period (at 60seconds) or lately (90 or 120 s) and waiting until the child receives additional sevoflurane inhalation anesthesia.
15873908|NCT03851679|Diagnostic Test|B-Type natriuretic peptide (BNP) serum values|"evaluation BNP serum values:
~pre- Cesarean Section (30 minutes before surgery)
~post- Cesarean Section (6 hour and 24 hour after surgery)"
15873909|NCT03851679|Device|Pulmonary echography|"Pulmonary echography:
~pre- Cesarean Section (30 minutes before surgery)
~post- Cesarean Section (6 hour and 24 hour after surgery)"
15873910|NCT03851679|Other|urine collection|6 hour and 24 hour urine collection after Cesarean Section
15873911|NCT03851666|Dietary Supplement|12 weeks daily administration Cereal 1|"The subjects will come to a visit every 4 weeks for a total period of 12 weeks. At the first, the second and the third visit the subjects will be supplied with a 5-week supply of product.
~Each daily administration will be supplied in a sachet. Subjects will be instructed to mix the contents of the sachet with 200mL of water and drink the solution within 5 minutes after preparation.
~The daily dose administrated is 15 grams."
15873912|NCT03851666|Dietary Supplement|12 weeks daily administration Cereal 2|"The subjects will come to a visit every 4 weeks for a total period of 12 weeks. At the first, the second and the third visit the subjects will be supplied with a 5-week supply of product.
~Each daily administration will be supplied in a sachet. Subjects will be instructed to mix the contents of the sachet with 200mL of water and drink the solution within 5 minutes after preparation.
~The daily dose administrated is 15 grams."
15873951|NCT03851328|Other|BPMH structured interview|creating a standardized medication list by interviewing patient and/ or relatives according to Best Possible Medication History (BPMH) after patient transfer to medical ward
15874025|NCT03850704|Drug|Selinexor|
15873913|NCT03851666|Other|12 weeks daily administration Placebo|"The subjects will come to a visit every 4 weeks for a total period of 12 weeks. At the first, the second and the third visit the subjects will be supplied with a 5-week supply of placebo.
~Each daily administration will be supplied in a sachet. Subjects will be instructed to mix the contents of the sachet with 200mL of water and drink the solution within 5 minutes after preparation."
15873914|NCT03851653|Behavioral|Lifestyle Intervention|Cognitive-behavioural intervention for weight loss and lifestyle change
15873915|NCT03851640|Drug|HC-1119|oral
15873916|NCT03851640|Drug|placebo|oral
15873917|NCT03851627|Drug|Testosterone Undecanoate|1000mg/4ml i.m. initial, after 6 weeks, every 10 weeks thereafter
15873918|NCT03851627|Drug|Placebo|Placebo Arm
15873919|NCT03851614|Biological|Durvalumab|Durvalumab is a human immunoglobulin G (IgG)1 kappa monoclonal antibody directed against human PD-L1. Durvalumab selectively binds human PD-L1 with high affinity and blocks its ability to bind to PD-1 and cluster of differentiation (CD)80. The fragment crystallizable (Fc) domain of durvalumab contains a triple mutation in the constant domain of the IgG1 heavy chain that reduces binding to the complement component C1q and the Fc gamma receptors responsible for mediating antibody dependent cell mediated cytotoxicity.
15873920|NCT03851614|Drug|Olaparib|Olaparib (AZD2281) is a potent oral poly Poly (ADP-ribose) Polymerase (PARP) enzyme inhibitor (PARP-1, -2 and -3) that is being developed as an oral therapy, both as a monotherapy (including maintenance) and for combination with chemotherapy and other anti-cancer agents. Olaparib specifically traps PARP1 and PARP2 enzymes at sites of damaged DNA; the trapped PARP1- or PARP2-DNA complex is cytotoxic and produces clinical response. Although olaparib also binds to PARP3, recent investigations have suggested PARP-3 inhibition does not contribute towards anti-cancer activity.
15873921|NCT03851614|Drug|Cediranib|Cediranib (AZD2171) is a potent oral small molecule Vascular Endothelial Growth Factor (VEGF) receptor tyrosine kinase inhibitor, specifically inhibiting all three VEGF receptors (VEGFR-1, -2 and -3). It has additional inhibitory activity against stem cell factor receptor tyrosine kinase, and less potency against platelet-derived growth factor receptor tyrosine kinases. Cediranib exerts its anti-angiogenic property by competitively inhibiting the ATP binding site on the VEGF receptors.
15873922|NCT03851601|Other|blood samples|Blood samples from 15 patients who receive ECP as part of the treatment of GVHD at our institution will be collected. Samples will be analyzed using the flow cytometer
15873923|NCT03851588|Other|Placebo|Dolutegravir-lamivudine-tenofovir fixed-dose combination tablet daily is not given with a supplementary dose of dolutegravir 50 mg.
15873924|NCT03851588|Drug|Dolutegravir 50 mg|Dolutegravir-lamivudine-tenofovir fixed-dose combination tablet daily is given with a supplementary dose of dolutegravir 50 mg.
15873925|NCT03851575|Other|Accelerated treatment of endocarditis|For the three main bacteria species we shorten the duration of antibiotic treatment
15873926|NCT03851575|Other|Usual guideline therapy|Usual guideline therapy
15873927|NCT03851562|Drug|Alprostadil 20 micrograms|Intravenous infusion of PGE1 (Days 0, +1 and +2)
15873928|NCT03851562|Drug|Placebo|Intravenous infusion of physiological saline solution
15873929|NCT03851549|Device|New BGMS (US)|New blood glucose monitoring system / In vitro diagnostic device (IVDD)
15873930|NCT03851536|Procedure|Transvaginal Ultrasound Guided ET|Use of TVUS to guide ET
15873931|NCT03851536|Procedure|Transabdominal Ultrasound Guided ET|Use of TAUS to guide ET
15873932|NCT03851523|Other|No intervention|No intervention
15873933|NCT03851471|Drug|Jiu-wei-zhen-xiao Granule|Patients will be treated for 12 weeks, with oral administration of 5g once of Jiu-wei-zhen-xiao Granule,three times a day, based on the conventional treatment for HCC, such as antiviral treatment, supportive treatment or symptomatic treatment.
15873934|NCT03851445|Drug|Screening Platform|The screening study tests patient specimens to determine eligibility for participation in the biomarker-driven and non-matched sub-studies included within the Lung-MAP umbrella protocol.
15873935|NCT03851432|Drug|Janagliflozin plus metformin|Janagliflozin: Tablets, Oral, 25 mg, Once daily, 52 weeks The patient's stable dose of background therapy of metformin should be continued throughout the study.
15873936|NCT03851432|Drug|Janagliflozin plus metformin|Janagliflozin: Tablets, Oral, 50 mg, Once daily, 52 weeks The patient's stable dose of background therapy of metformin should be continued throughout the study.
15873937|NCT03851432|Device|Placebo plus metformin|Placebo: Tablets, Oral, 25/50 mg, Once daily, 24 weeks The patient's stable dose of background therapy of metformin should be continued throughout the study.
15873938|NCT03851419|Diagnostic Test|Diagnosis of (Neuro)cysticercosis|"Serological tests for cysticercosis
~Neurological examination and cerebral CT scan for the diagnosis of neurocysticercosis
~Stool testing for T. solium"
15873939|NCT03851406|Device|5% Hypertonic Saline|Subjects will inhale 15 mL of 5% HS for 15 minutes delivered by an ultrasonic nebulizer with a coached cough maneuver
15873940|NCT03851393|Other|Induction of cough with inhaled citric acid|perform artificially induced cough by inhalation of citric acid at various strengths
15873941|NCT03851393|Procedure|Peptest™ analysis of saliva pepsin|collect patient saliva for analysis of pepsin levels
15873942|NCT03851393|Diagnostic Test|Peptest™|The Peptest™ lateral flow device
15873943|NCT03851380|Behavioral|Psychological / Functional Assessment|Psychological and functional assessment battery to characterize participants.
15873944|NCT03851380|Other|Structural and Functional MRI|Structural and functional magnetic resonance imaging session.
15873945|NCT03851380|Device|Transcranial Magnetic Brain Stimulation and MR Image Guidance|MRI guided transcranial magnetic stimulation and measurement of targeting accuracy.
15873946|NCT03851367|Procedure|Sling suspension using red cord|3 weeks duration, 15 sessions, and 30 minutes a day for five consecutive days a week. Back pain, endurance of trunk muscles (flexors, extensors and side flexors), and standing posture were evaluated pre and post interventions.
15873947|NCT03851367|Procedure|Gym ball exercises|3 weeks duration, 15 sessions, and 30 minutes a day for five consecutive days a week. Back pain, endurance of trunk muscles (flexors, extensors and side flexors), and standing posture were evaluated pre and post interventions.
15873948|NCT03851354|Other|Ultrasound meal acommodation test|to observe their tolerance a 500 ml of solution with glutamine, or Caseinate and the protocol will be carried out will be given. Ultrasound measures will be performed and observing changes in Cross Sectional Area of the gastric antrum of the first measurement at the time after administration. Gastric residue will be measured.
15873952|NCT03851315|Device|permanent left bundle branch area pacing|Implant the pacing lead in the left bundle branch area instead of traditional RV pacing site(septal or apical). Successful LBBAP was defined as the paced QRS morphology of right bundle branch block pattern in lead V1 and QRS duration (QRSd) less than 130ms.
15873953|NCT03851302|Other|Active Remote Ischemic Conditioning|The active RIC protocol involves 5 cycles of 5-min inflation and 5-min deflation on the non-target arm. The active RIC will be achieved via blood pressure cuff inflation to 200 mmHg.
15873954|NCT03851302|Other|Sham Remote Ischemic Conditioning|The sham RIC protocol involves 5 cycles of 5-min inflation and 5-min deflation on the non-target arm. The sham RIC will be achieved via blood pressure cuff inflation to 10 mmHg below the subjects' diastolic blood pressure which would not cause the blood occlusion.
15873955|NCT03851302|Other|Isometric hand exercise|Participants will be instructed to pinch a dynamometer with thumb and index finger at different intensities and durations. The intensities of pinch force will be 10%, 25%, and 50% of the maximal voluntary contraction (MVC). For each intensity, durations of 2, 4, and 6 s will be employed, which resulted in nine different combinations delivered in pseudorandom order. Participants will perform 2 sets of the isometric hand exercise (18 pinches in total). The interval between each pinch will be 2 seconds, with 30 second intervals between each set.
15873956|NCT03851289|Combination Product|platelet-rich fibrin and calcium sulfate|
15873957|NCT03851289|Combination Product|platelet-rich fibrin and xenograft|
15873958|NCT03851276|Radiation|Multi-sliced computed tomography (MSCT)|Surgery planning done based solely on MSCT.
15873959|NCT03851263|Biological|Evolocumab|Subcutaneous injection, using a pre-filled auto-injector pen. Each pen contains 1.0 ml fluid (containing 140 mg evolocumab) which is injected in the abdomen, thigh or outer area of upper arm every 2 weeks (q2w).
15873960|NCT03851250|Drug|MRx-4DP0004|Participants randomised to receive MRx-4DP0004 will take it in addition to their regular asthma medication.
15873961|NCT03851250|Drug|Placebo|Participants randomised to receive placebo will take it in addition to their regular asthma medication.
15873964|NCT03851224|Procedure|control group|immediate implant with immediate loading using no graft
15873965|NCT03851224|Procedure|study group|immediate implant with immediate loading using autogenous bone graft
15873966|NCT03851224|Procedure|study group 2|immediate implant with immediate loading using (Geistlich Bio-Oss®) xenograft
15873967|NCT03851198|Procedure|Standard Care or Usual Clinical Practice|The guidelines for the management according to the mild cognitive impairment in primary care will be the treatment guidelines for the Standard Care.
15873968|NCT03851172|Drug|Ketorolac Ophthalmic|Preoperative administration of Ketorolac 0.5% eye drops
15873969|NCT03851172|Drug|Nepafenac Ophthalmic|Preoperative administration of Nepafenac 1 mg eye drops
15873970|NCT03851172|Drug|Cyclopentolate Ophthalmic|Preoperative administration of Cyclopentolate eye drops
15873971|NCT03851159|Dietary Supplement|Nyaditum resae®|Heat-killed Mycobacterium manresensis
15873972|NCT03851159|Other|Mannitol|Placebo
15873973|NCT03851146|Biological|LeY CAR T cells|Autologous peripheral blood T-lymphocytes transduced with the anti-LeY-scFv-CD28-ζ vector (LeY CAR T cells)
15873977|NCT03851120|Dietary Supplement|Probiotics and LC-PUFA (480 mg DHA)|Probiotics and LC-PUFA (480 mg DHA)
15873978|NCT03851120|Dietary Supplement|Placebo probiotics and control LC-PUFA (120 mg DHA)|Placebo probiotics and control LC-PUFA (120 mg DHA)
15873979|NCT03851120|Behavioral|Psychosocial stimulation and healthy eating education|Psychosocial stimulation and healthy eating education
15873980|NCT03851107|Behavioral|Engagement in 6-week community-based activity program|Participants engage in a 6-week community-based activity program of their choice. In order to engage in the selected activity, an Occupational Therapist (OT) will meet with each youth in their home. Using the PREP 5 steps (Make goals; Map out a plan; Make it happen; Measure the process and outcomes; Move forward) the youth will choose a community program. The OT will then search for the appropriate program, identify and remove potential environmental barriers for participation in that activity (e.g., accessibility, equipment) and educate program instructors regarding the youth's specific needs. This process, which includes up to 12 hours of working with the OT, will set the stage for enrolment of the youth in a community program for a period of 6 weeks - the actual intervention phase.
15873981|NCT03851094|Behavioral|Wellth app|The intervention is the use of Restful, the Wellth self-management app. There is no clinical treatment intervention, as all participants will be receiving PAP therapy per standard of care. Restful is a smartphone-based patient engagement tool that utilizes concepts from behavioral economics to help patients improve their adherence to therapy. The intervention includes a financial and social incentive reward program.
15873985|NCT03851068|Device|Foldax Tria Aortic Valve|Aortic Valve Replacement
15873986|NCT03851055|Drug|Zinc|One arm will receive Zinc Second arm will receive placebo
15873987|NCT03851042|Device|Virtual Reality Head set in PACU|Use of VR headset to determine post op satisfaction in PACU, decreased pain reduction and opioid consumption
15873988|NCT03851042|Other|No intervention|Routine post laparoscopic hysterectomy management (no VR headset)
15873989|NCT03851029|Other|Tai chi|"Session:
~• 3 times a week for 30-45 min.
~Duration:
~• For 6 weeks
~Warm-up:
~• 10-15 mints
~Cool-down:
~• 10-15 mints or stretching's
~Exercises time:
~• 20-30 mints"
15874800|NCT03844763|Drug|Avelumab|Avelumab: 10 mg/kg every 2 weeks, untill PD or major toxicity
15873990|NCT03851029|Other|Aerobic Training|"Session:
~• 3 times a week for 30-45 min.
~Duration:
~• For 6 weeks
~Warm-up:
~• 10-15 mints
~Cool-down:
~• 10-15 mints or stretching's
~Exercises time:
~• 20-30 mints"
15873991|NCT03851016|Behavioral|Life Story Book|Life story Book is intended to allow a person the opportunity to reminisce chronologically through their life and capture their life stories into a book.
15873992|NCT03851016|Behavioral|Usual Care|Three weeks of Usual Care with no visits from research team
15873993|NCT03851003|Procedure|Endometrial suturing|Suturing will include endometrium during cesarean incision repair
15873994|NCT03851003|Procedure|Non- endometrial suturing|Suturing will not include endometrium during cesarean incision repair
15873995|NCT03851003|Device|Vaginal ultrasonography|All women will be invited six month post operation for vaginal sonographic evaluation of the uterine scar
15873996|NCT03851003|Other|Questionnaire|All women will be invited six month post operation for filling questionnaire concerning possibility of uterine scar defect ( spotting, pelvic pain, fertility abnormalities )
15873997|NCT03850990|Behavioral|Placebo pill and no placebo pill|The placebo pills will be green and white gelatin capsules containing microcrystalline cellulose and other inert ingredients.
15873998|NCT03850964|Drug|Pazopanib|gel capsule, with 25mg-similar fills
15873999|NCT03850964|Drug|Placebo oral capsule|identical gel capsule without active pharmaceutical ingredient
15874000|NCT03850951|Device|Lingual appliances|Patients with moderate crowding will be treated without extraction using lingual appliances.
15874001|NCT03850951|Device|Labial appliances|Patients with moderate crowding will be treated without extraction using labial appliances.
15874002|NCT03850938|Device|Conventional Kyphoplasty|The cement is injected into the cavity created by PKP. The diffusion of cement can be interfered by closely barriers formed by surrounding cancellous bones.
15874003|NCT03850938|Device|Kyphoplasty with Rotary Cutter|The rotary cutter is applied before cement injection to destroy the structure around the cavity created by inflated balloon. Then, the rotary cutter will make the bone cement to support a wider range and to blend with the surrounding cancellous bones more densely.
15874004|NCT03850925|Procedure|Laser therapy|4 consecutive sessions of laser therapy
15874005|NCT03850912|Other|eSyM App Usage|Patients (and/or proxy) will report their cancer-related symptoms and receive tailored feedback via eSyM
15874006|NCT03850912|Other|SASS Questionnaire|"A subset of eSyM+ and eSyM- patients will be asked to complete a research questionnaire called the SASS Questionnaire asking about their Self-efficacy, Attainment of information needs, Symptom burden, and Satisfaction with care (see PROMIS, CAHPS, IAM/AIM question banks - Appendices C through G). The questionnaire will stop being administered once 1800 total surveys have been received."
15874007|NCT03850886|Dietary Supplement|Niacinamide Oral Tablet|Nature's Life Niacinamide 1000 mg
15874008|NCT03850886|Drug|Antidiabetic|Metformin or Sulphonylurea
15874009|NCT03850873|Drug|TQB3616|TQB3616 administerde days 28 of a 28-day schedule,doses ranging from 20m，40mg，60mg，80mg，100mg，120mg once daily
15874010|NCT03850860|Other|empirical antibiotherapy|comparison of the outcome in the 2 groups having had 2 different empirical antibiotherapies
15874011|NCT03850847|Other|Step 1: Semi-structured Interviews|"Cover SDMs' experience around:
~withdrawal of life sustaining therapies
~organ donation among those who were approached (including with the medical team and the organ donation organisation)
~understanding of the situation
~views on any gaps in the quantity or quality of information and discussion they received concerning their loved one's end-of-life care or donation process
~Explore factors they perceived to influence their decision to consent to organ donation or not (or that would have influenced their decision for those not approached), and how such factors may have changed over the course of making this decision and since the decision (or since the event for those not approached)."
15874012|NCT03850847|Other|Step 2: National Telephone Survey|Explore SDM's beliefs and experiences around end of life and assess which beliefs are associated with the decision taken at the end of life, including decision to donate organs or not (and the strength of this association)
15874013|NCT03850834|Drug|Ammoxetine Hydrochloride Enteric-coated Tablets|There will be 3 ascending cohorts. The cohorts will be administered 15, 30, 45 mg q12h for 15 times. The results of each dose group were shown to be safe and tolerable, and then the next dose group was tested
15874014|NCT03850834|Drug|placebo enteric-coated tablets|There will be 3 ascending cohorts. The cohorts will be administered 15, 30, 45 mg q12h for 15 times. The results of each dose group were shown to be safe and tolerable, and then the next dose group was tested
15874015|NCT03850821|Behavioral|Connect Social Mechanisms Intervention|"The Get-to-Know-You small group sessions (30 minutes) were designed to increase friendship building skills and involved interactive student-led discussions and activities designed to foster the assets needed to build and support friendships, group cohesion, and staff connections through PA. The PA component of the program (60 minutes) was designed to promote a positive PA social experience and meet youth social affiliation goals. Available games to choose from were novel, inclusive, emphasized teamwork, and centered on social goals. Three different PA stations were offered each program day in which youth rotated. One day each week was designated as a choice day, whereby youth activity preference ratings were used to determine which activities were offered that day."
15874019|NCT03850769|Drug|nab-paclitaxel and S-1|Nab-Paclitaxel: 120 mg/m2 d1, 8, S-1: Body surface area < 1.25 m2, 80 mg/d; Body surface area ≥ 1.25 m2 < 1.50 m2, 100 mg/d; Body surface area ≥1.5 m2, 120 mg/d; Bid, d1-14;
15874020|NCT03850756|Diagnostic Test|Early kidney damage biomarkers|In the urine samples of these patients, a series of biomarkers of early kidney damage and / or predisposition to kidney damage will be measured.
15874021|NCT03850756|Diagnostic Test|Predisposition to kidney injury biomarkers|In the urine samples of these patients, a series of biomarkers of predisposition to kidney damage will be measured.
15874022|NCT03850756|Diagnostic Test|Tobacco consumption|In order to know the degree of tobacco consumption, the biomarker cotinine will be measured in the urine samples of these patients.
15874023|NCT03850730|Drug|Pazopanib|Active pharmaceutical ingredient plus excipients filled into a capsule for the lower dosing necessary in this study
15874026|NCT03850691|Drug|Aldesleukin: All Patients|"Cycle 1:
~(600,000 U/kg/dose) given as a bolus infusion once every 8 to 12 hours over 5 days or until no longer tolerated (to a maximum of 10 doses). Administered as an inpatient.
~Days 1-5 and Days 15-19 (all patients)"
15874027|NCT03850691|Drug|Nivolumab: Cohort 1 (Cutaneous)|"Cycle 1: 6 Week Duration Nivolumab 240 mg IV
~Cycle 2: 6 Week Duration Nivolumab 240 mg IV on Day 1, 15 and 29
~Cycle 3: 4 Week Duration Nivolumab 240 mg IV on Day 1 and 15
~Patients may continue maintenance nivolumab 240 mg IV every 2 weeks OR nivolumab 480 mg IV every 4 weeks per 2018 FDA approval at discretion of the treating physician and independent of this study"
15874028|NCT03850691|Drug|Nivolumab: Cohort 2 (Ocular)|"Cycle 1: 6 Week Duration Nivolumab 3 mg/kg IV on Day 29
~OR for a high risk patient with an excellent performance status, the following regimen may be given at the discretion of the treating investigator:
~Nivolumab 1 mg/kg IV on Day 29
~Cycle 2: 6 Week Duration Nivolumab on Day 8 and on Day 29 using the same dose regimen as used Cycle 1 Day 29
~Cycle 3: 4 Week Duration Nivolumab on Day 8 using the same dose regimen as used Cycle 1 Day 29.
~Patients may continue maintenance nivolumab 240 mg IV every 2 weeks OR nivolumab 480 mg IV every 4 weeks per 2018 FDA approval at discretion of the treating physician and independent of this study"
15874029|NCT03850691|Drug|Ipilimumab: Cohort 2 (Ocular)|"Cycle 1: 6 Week Duration Ipilimumab 1 mg/kg IV on Day 29
~OR for a high risk patient with an excellent performance status, the following regimen may be given at the discretion of the treating investigator:
~Ipilimumab 3 mg/kg IV on Day 29
~Cycle 2: 6 Week Duration Ipilimumab on Day 8 and on Day 29 using the same dose regimen as used Cycle 1 Day 29
~Cycle 3: 4 Week Duration Ipilimumab on Day 8 using the same dose regimen as used Cycle 1 Day 29"
15874031|NCT03850665|Procedure|Direct Anterior Approach (DAA)|Direct Anterior Approach surgery to replace the hip.
15874032|NCT03850665|Procedure|Anterolateral approach|Anterolateral approach surgery to replace the hip.
15874033|NCT03850652|Dietary Supplement|Prebiotic (Synergy-1) + Iron supplement|In addition, participants will be required to take one 7 g sachet of prebiotic food supplement daily. In addition, participants will be required to take one daily tablet of a generic, iron supplement (200 mg FeSO4 equivalent to 65 mg iron) (provided by pharmacy).
15874034|NCT03850652|Dietary Supplement|Placebo (Maltodextrin) + Iron Supplement|participants will be required to take one 7 g sachet of placebo (maltodextrin) daily. In addition, participants will be required to take an iron supplement (200 mg FeSO4 equivalent to 65 mg iron) (provided by pharmacy).
15874035|NCT03850639|Behavioral|Internet-based exposure therapy|The treatment is a three week long cognitive behavior therapy. It is based mainly on the principles of exposure; i.e. the participant is instructed to approach the memory of the traumatic event and situations they since the traumatic events are associated with fear and anxiety. Other interventions include psychoeducation, and breathing retraining to facilitate exposure.
15874036|NCT03850626|Biological|Immunotherapy|subcutaneous injection
15874037|NCT03850613|Behavioral|E-painting mobile app|The subjects can use the newly developed mobile app to draw their own pictures at the time convenient to them.
15874038|NCT03850600|Other|Diet-CD|CD patients will self-select into the intervention arm to follow the diet for 8-10 weeks during their third trimester of pregnancy.
15874039|NCT03850587|Drug|Celecoxib 200mg|comparator medication
15874040|NCT03850587|Drug|Tramadol 37.5Mg+ Celecoxib 200mg|experimental medication
15874041|NCT03850587|Drug|Tramadol 75mg+ Celecoxib 200mg|experimental medication
15874042|NCT03850587|Drug|Tramadol 150mg+ Celecoxib 200mg|experimental medication
15874043|NCT03850574|Drug|HM43239|Daily (QD), continuous dosing
15874044|NCT03850561|Dietary Supplement|Coenzyme Q10 200|Coenzyme Q10 200 mg/day
15874045|NCT03850561|Dietary Supplement|Coenzyme Q10 400|Coenzyme Q10 400 mg/day
15874046|NCT03850548|Other|Prosthetic joint infection with Cutibacterium acnes|patients having a prosthesis infection with C.acnes identified by specific PCR
15874047|NCT03850535|Drug|Idasanutlin|Participants will self-administer idasanutlin tablets by mouth (PO) once daily (QD) for 5 days of each 28-day treatment cycle for up to 2 cycles of induction, up to 4 cycles of consolidation, and 12 cycles of maintenance, according to the study's protocol.
15874048|NCT03850535|Drug|Cytarabine|Cytarabine will be administered for 7 days of each 28-day cycle for up to 2 cycles of induction treatment at a dose of 200 milligrams per meter squared (mg/m^2) of body surface area, once daily (QD) by intravenous (IV) infusion. At the investigator's discretion, cytarabine will also be administered as part of chemotherapy consolidation at a dose of 1.5 g/m^2 QD as IV infusion for 5 days of each 28-day cycle and for up to 4 cycles of treatment.
15874049|NCT03850535|Drug|Daunorubicin|Daunorubicin will be administered for 3 days of each 28-day cycle for up to 2 cycles of induction treatment at a dose of 60 mg/m^2 QD as IV infusion.
15874050|NCT03850535|Procedure|Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)|After induction treatment, participants who achieve remission will either receive chemotherapy consolidation treatment or undergo Allo-HSCT (as per local guidelines) at the investigator's discretion.
15874051|NCT03850522|Biological|PD-L1 peptide|PD-L1 peptide (100 micrograms) emulsified with the adjuvant Montanide ISA-51 given subcutaneously 10 times every second week over the course of 26 weeks including a five-week break.
15874052|NCT03850509|Drug|OPS-2071|OPS-2071 300 mg, tablets, orally, BID.
15874053|NCT03850509|Drug|Placebo|OPS-2071-matched placebo, tablets, orally, BID.
15874054|NCT03850496|Device|Revitive IX Neuromuscular Stimulation Device|Neuromuscular stimulation footplate device with a pre-programmed 30 minute varying electrical stimulation sequence.
15874055|NCT03850483|Drug|PF-06700841|PF-06700841 topical cream
15874056|NCT03850483|Drug|Vehicle (Placebo)|Vehicle topical cream
15874057|NCT03850470|Diagnostic Test|clinical examination|Thorough examination including history, screening, motion testing, strength testing, special testing
15874058|NCT03850470|Other|MRI|Low field MRI .25 Tesla
15874059|NCT03850457|Other|No intervention|The treatments will be determined by their neonatologists and no additional investigational drugs will be applied to the infants included in this study.
15874060|NCT03850444|Biological|pembrolizumab|
15874061|NCT03850444|Drug|carboplatin|
15874062|NCT03850444|Drug|paclitaxel|
15874063|NCT03850444|Drug|pemetrexed|
15874177|NCT03849547|Other|App Balance training|"Training specially designed for balance ability of chronic ankle instability groups.
~Guidance through smartphone application as home program."
15874064|NCT03850431|Behavioral|Social Norms + Behavioral Instructions|A letter with two types of nudges. One points out the common behavior of attending appointments. And one provides clear, specific instructions for making appointment changes. The appointment reminder also includes usual care (basic appointment information on date, location, and phone number(s) for scheduling changes).
15874065|NCT03850431|Behavioral|Caring + Consequences for Others + Behavioral Instructions|A letter with three types of nudges. One suggests that the institution cares about the patient. One highlights a potential negative consequence for others if the patient no-shows. And one provides clear, specific instructions for making appointment changes. The appointment reminder also includes usual care (basic appointment information on date, location, and phone number(s) for scheduling changes).
15874066|NCT03850431|Behavioral|Caring + Consequences for Self + Behavioral Instructions|A letter with three types of nudges. One suggests that the institution cares about the patients. One highlights potential negative consequences for the patient if s/he no-shows. And one provides clear, specific instructions for making appointment changes. The appointment reminder also includes usual care (basic appointment information on date, location, and phone number(s) for scheduling changes).
15874067|NCT03850431|Behavioral|Caring + Consequences for Others + Consequences for Self + Social Norms + Behavioral Instructions|A letter with all four types of nudges combined. One suggests that the institution cares about the patients. One highlights a potential negative consequence for others if the patient no-shows. One highlights potential negative consequences for the patient if s/he no-shows. One points out the common behavior of attending appointments. And one provides clear, specific instructions for making appointment changes. The appointment reminder also includes usual care (basic appointment information on date, location, and phone number(s) for scheduling changes).
15874068|NCT03850418|Drug|azacitidine|azacitidine 32mg/m2 x 5 days every 28 days for minimum of 4 cycles if tolerated
15874069|NCT03850405|Dietary Supplement|Dark Chocolate|20 patients (10 male, 10 female) will undergo a diet containing 25g of dark chocolate (70%), corresponding to ca. 145 kcal which will be detracted from the total caloric intake.
15874070|NCT03850392|Device|cryotherapy (Thermogel - Artsana or Cryo+ - Cryonic)|cold application (ice 30 min or cold CO2 2 min) twice during 1 day at an 8 hour-interval
15874071|NCT03850379|Drug|Levofloxacin|This is a prospective study comparing consecutive patients who will be be receiving ciprofloxacin prophylaxis vs. levofloxacin prophylaxis for Stem cell transplant till engraftment defined as ANC >1000
15874072|NCT03850379|Drug|Ciprofloxacin|This is a prospective study comparing consecutive patients who will be be receiving ciprofloxacin prophylaxis vs. levofloxacin prophylaxis for Stem cell transplant till engraftment defined as ANC >1000
15874073|NCT03850366|Drug|Bortezomib|GVHD prophylaxis
15874074|NCT03850327|Device|BIOMONITOR III|Patients with ICM indication receive a third-generation implantable cardiac monitor
15874075|NCT03850314|Dietary Supplement|Glycine|Glycine powder to be dissolved in water.
15874076|NCT03850301|Drug|XBD173|7 days treatment
15874077|NCT03850301|Drug|Etifoxine|7 days treatment
15874078|NCT03850288|Other|Neuropsychological assessment : Stroop task|"Stroop task is an interference task assessing cognitive inhibitory control. This paper-and-pencil task aims to evaluate the inhibition of an automated process such as reading by asking participants to name the color of color names written in a different color ink.
~This test is non-invasive."
15874079|NCT03850288|Other|Neuropsychological assessment : Go No Go task|"Go No Go task assessing motor inhibitory control. This computer-based task is designed to evaluate motor inhibition by asking participants to respond to a stimulus as quickly as possible by inhibiting another distractor stimulus.
~This test is non-invasive."
15874080|NCT03850275|Dietary Supplement|Intervention/treatment|Subjects received all 3 interventions Placebo ~3mg caffeine Caffeinated placebo ~100mg caffeine E+shots- The 4oz adaptogen-rich (E+shots) was E+ Shots (Isagenix International, LLC) containing approximately 90mg caffeine from green tea Camellia sinesis leaf extract (50%) and yerba maté extract (25%) along with a proprietary blend of adaptogenic herbs, including: eleutherococcus senticosus, crateagus oxycantha, rhodiola rosea and Schisandra chinensis.
15874081|NCT03850262|Radiation|MRI|"The study will be done on 1.5T MR unit (Siemens) and 1.5T MR unit (Philips) at Assuit University Hospital, or 1.5T MR unit (G.E.) at Eman General Hospital.
~The field of view varied between 14 cm and 16 cm, and slice thickness varied between 3 and 4 mm, with 0.5 mm intersection gap.
~Imaging sequences included sagittal PD proton density, T2 and STIR, axial PD, coronal STIR and coronal oblique."
15874082|NCT03850210|Device|Short Splint|Short Splint that permits maximal wrist flexion and up to 45° of wrist extension with a block to 30° of MCP joint extension.
15874083|NCT03850210|Device|Traditional Long Splint|Traditional splint is a forearm-based dorsal thermoplastic splint that immobilizes the wrist in neutral position with a block to 30° of metacarpophalangeal (MCP) joint extension
15874084|NCT03850197|Device|EarPopper|"The EarPopper is 510(K) regulated (510(K) Number K073401) and is marketed as a safe and effective way to aid muscle-assisted ET opening. It is a Politzer device, and aids ET opening by blowing a constant stream of air into the nasal cavity. It consists of a single nose piece connected to an air pump with no adjustable pressure settings. During the study, the subject will be asked to place the nose piece into one of the nostrils while occluding the contralateral. The subject will then perform the maneuvers (swallow, Fish, blowing out into the EMST-150)."
15874085|NCT03850197|Device|Tympanometry|The Tympanometer is 510(K) regulated (510(K) Number K083861) and is marketed as a way to measure auditory impedance and acoustics reflex by producing controlled levels of test tones and signals. It will be used before and after each maneuver for both the EarPopper and Tubomanometry tests to assess middle ear pressure change.
15874086|NCT03850197|Device|Tubomanometry|"Tubomanometry is an established test of Eustachian tube function. It is an easily-administered test used in clinical laboratories. It consists of a nosepiece and an ear canal pressure probe coupled to a manometer and air pump. When the nosepiece and ear canal probe is in place, a maneuver, such as swallowing, will cause the tubomanometer to generate a bolus of air at 30, 40, or 50 mbar through the nosepiece. In the event that the Eustachian tube opens, the tympanic membrane will be displaced, which in turn will be sensed by the ear probe. This event will be recorded as a Eustachian tube opening. For this test, the investigators will ask the subject to perform the maneuvers (swallow, Fish, blowing out into the EMST-150)."
15874087|NCT03850184|Diagnostic Test|The Exercise in Mental Illness Questionnaire (EMIQ)|Questionnaire assessing prescription behaviour, knowledge, barriers and behaviour of physical activity in mental health professionals
15874088|NCT03850171|Other|Exercise Training|Participants from the experimental study arm are assigned to a 12-week exercise training programme integrated in a multidisciplinary oncology rehabilitation programme at the Inselspital Bern, Spital AG Thun, or Bürgerspital Solothurn. The exercise programme will comprise 2 weekly exercise sessions lasting 90 min, supervised by experienced exercise therapists. The sessions start with approximately 40 min cycling on an ergometer at moderate intensity, increasing on a weekly basis if possible. After the cycling training, patients continue the exercise session with 40 min of strength training, stretching, relaxation, coordination and balance training. In addition, patients will be instructed to perform at least one additional endurance-related activity per week in their own time with a duration of 30-60 min at moderate intensity levels (e.g. walking, bicycling).
15874089|NCT03850158|Drug|Indocyanine Green|Indocyanine green is administered intra-venous after dilution with water in a peripheral vein at a dosage of 0.3mg/kg body weight as a bolus injection. The injection will take place during surgery. By using NIR fluorescence imaging ICG is made visible.
15874090|NCT03850132|Behavioral|FAM-SOTC-PL|"The adapted FAM-SOTC-PL intervention was delivered at the home of the participants and focuses on supporting the effective, cognitive, and behavioural domains of the bereaved family caregivers experience by targeting concerns/issues in these categories. The FAM-SOTC-PL comprises of the following five components:
~Drawing forward narratives about the pre- and post-loss experience.
~Asking therapeutic/interventive questions, emphasising on the most pressing concerns also assessing health issues.
~Validating/acknowledging emotional responses.
~Assessing the need for specific information and recommendations regarding bereavement.
~The use of commendation/commending strengths, by focusing on and affirming the strengths of the family caregiver."
15874091|NCT03850119|Procedure|Nanofat injection|Lipoaspirate, harvested during the surgery, is centrifuged for 1 minute at 2000 rpm to discard infiltration fluid. The residual fat is passed back and forth between two 10cc syringes interlocked with Tulip connecting pieces (2.4, 1.4 and 1.2 diameter, each 10 passes for a total of 30 passes). This is injected intradermally before the intradermal sutures are placed. The donor site is always entirely sutured (both sides) by the same person.
15874092|NCT03850106|Dietary Supplement|Placebo|Placebo
15874093|NCT03850106|Dietary Supplement|Indus810|Active product
15874094|NCT03850093|Drug|Gabapentin1200 mg|patients received 1200mg gabapentin 2 hrs preoperative
15874095|NCT03850093|Drug|bisoprolol 2.5mg|patients received 2.5mg bisoprolol 2 hrs preoperative
15874096|NCT03850093|Drug|placebo|patients received oral placebo 2 hrs preoperative
15874097|NCT03850080|Drug|Autologous Conditioned Serum|"Fifteen patients with clinical and radiological signs of OA of the knee were recruited for this study. 50mL of whole blood were taken using a special syringe containing CrSO4-coated grade glass beads in order to promote IL-1ra synthesis and aggregation.The incubation period lasted 7 hours after which, the blood-filled syringes were centrifuged and the serum supernatant was filtered and aliquoted into four 3mL portions. The aliquots were stored at -20oC until their use was necessary.
~Patients received 1 intra-articular injection for 4 consecutive weeks at the site of OA."
15874098|NCT03850067|Drug|CC-90011|CC-90011
15874099|NCT03850067|Drug|Cisplatin|Cisplatin
15874100|NCT03850067|Drug|Carboplatin|Carboplatin
15874101|NCT03850067|Drug|Etoposide|Etoposide
15874102|NCT03850067|Drug|Nivolumab|Nivolumab
15874103|NCT03850054|Procedure|AADI glaucoma shunt|"Implantation of the nonvalved AADI glaucoma shunt instead of the Bearveldt tube shunt, in eyes with intractable glaucoma.
~It is not a RCT study, but a prospective evaluation of the AADI device, and the study has been approved as a quality control study at the Department of Ophthalmology, at Odense University Hospital"
15874104|NCT03850028|Other|89Zr-atezolizumab PET scans|"The anti-PDL1 antibody atezolizumab, labeled with Zirconium-89 (89Zr) will be used as a molecular imaging tracer for PET scanning.
~These 89Zr-atezolizumab PET scans will be performed before and after induction therapy (R-CHOP) and at suspected relapse during or after consolidation treatment with atezolizumab (treatment trial HOVON 151)."
15874105|NCT03850015|Diagnostic Test|Standard echocardiography|Patients will undergo standard echocardiography, with and without contrast
15874106|NCT03850015|Other|High frame rate echocardiography|Following standard echocardiography, the test is repeated using high frame rate ultrasound
15874107|NCT03850002|Other|Early detection of CLAD by Lung Clearance Index (LCI)|Lung transplant candidates without prior CLAD (evaluated in study part I) will be followed over a period of 3 years to evaluate the potential of LCI to detect early CLAD
15874108|NCT03849989|Procedure|Skin biopsy|"Skin biopsy:
~Tissue samples will be taken by punch biopsy according to the daily routine of the Department of Dermatology of the Maastricht UMC+.
~Steps:
~Skin desinfection with chlorhexidine digluconate 1% solution
~Local anaesthesia with lidocaine hydrochloride 1%
~Biopsy specimens are taken with sterile punch device (disposable biopsy punch delivered by kai medical)
~Biopsy specimens are retrieved with sterile pincer and cut with sterile blade
~Wound is stitched with a single transcutaneous stich using absorbable suture (vicryl 4.0).
~Wound will be treated with R/ fusidic acid ointment 3 to 5 times per day for two weeks
~In the first week after laser therapy the wound will be covered by R/ Urgotull non-adhesive gauze, R/ Cutisoft cotton non-sterile gauze and R/ Klinipress exsupad absorbing bandage."
15874109|NCT03849976|Behavioral|Therapeutic communication|Patients will be accompanied to the operating room by a stretcher bearer trained in therapeutic communication
15874110|NCT03849963|Drug|Hyperpolarized [13C]Pyruvate|Injection of hyperpolarized [13C]pyruvate, a stable isotope, during magnetic resonance spectroscopic imaging.
15874111|NCT03849950|Other|SMARTCare|"Ambulatory nurses will undertake 4 hours of training consistent with the evidenced-based guidelines for SMS in routine care.
~An education program for patients in the intervention arm that targets training in core self-management skills and is comprised of an introduction and 5 education modules.
~An introductory call from a health coach prior to initiating treatment and 5 subsequent calls: prior to the first dose of treatment; 7-14 days following the first dose of treatment; within 2 weeks of coaching session 2; and timing is flexible for the last 2 sessions, but to be completed within 4 months following the first dose of treatment.
~Optional sub-study: A sub-set of patients will participate in an end of study interview to gain further insight into SMARTCare."
15874112|NCT03849950|Other|Control|1. Ambulatory nurses will undertake 4 hours of training consistent with the evidenced-based guidelines for SMS in routine care.
15874248|NCT03849053|Other|Mézières Therapy for Low back pain|Spinal muscular global stretching
15874113|NCT03849937|Behavioral|Changing Talk Online (CHATO)|Three, one-hour online training modules highlighting barriers and ineffective communication behaviors with older adults while teaching and modeling alternative, effective communication strategies.
15874114|NCT03849924|Behavioral|Self-affirmation|Self-affirmation implementation intentions in the form of a questionnaire.
15874115|NCT03849911|Diagnostic Test|Neurophysiological Prognosis|SEP and EEG evaluation for Neurological Prognosis of Cardiac Arrest
15874116|NCT03849911|Diagnostic Test|Multimodal Prognosis for poor early neurological outcome|Brain CT, SEP and EEG evaluation
15874117|NCT03849898|Procedure|Surgery|Surgical fracture treatment
15874118|NCT03849898|Other|Non-Surgical fracture treatment|Non-Surgical fracture treatment
15874119|NCT03849885|Drug|Benzoyl peroxide gel|Skin prep with Chlorohexidine wipes and BPO.
15874120|NCT03849872|Drug|ONO-5788|Investigational Drug
15874121|NCT03849872|Drug|[14C]-ONO-5788|Investigational Drug
15874122|NCT03849859|Device|Single plastic stent|Deployment of single plastic stent
15874123|NCT03849859|Device|Multiple plastic stents|Deployment of multiple plastic stents
15874124|NCT03849846|Other|Focus groups|Participants will also complete a sociodemographic questionnaire. The moderator will conduct the discussion using a semi-structured interview guide, based on the construct of the Theory of Planned Behaviour. The interview guide has been developed to identify the beliefs that determine the participants' attitudes (advantages/disadvantages), subjective norms (approval/disapproval of important others) and perceived behavioural control (facilitators/barriers) related to a hypothetical participation in the NutriQuébec study. The participants will also be questioned about their preferences regarding the recruitment as well as their concerns about the security, use and share of data.
15874125|NCT03849833|Dietary Supplement|cholecalciferol, Vitamin D3|Vitamin D3 as dietary supplement
15874126|NCT03849820|Device|Robotic-assisted partial nephrectomy|Application of the da Vinci surgical robot to assist the partial nephrectomy
15874127|NCT03849820|Other|Open partial nephrectomy|Open surgery to conduct the partial nephrectomy
15874128|NCT03849807|Other|Experimental group|the intervention group will receive 4 weeks of chiropractic care along with usual care(Cognitive-Behavioral, psychosocial Therapy).
15874129|NCT03849807|Other|Control group|Participants in the group will receive usual health (Cognitive-Behavioral, psychosocial Therapy) care or wish to engage in during the course of the study as well as receiving a passive movement control intervention delivered by a chiropractor 3 times per week in the same hospital setting as the group receiving chiropractic care.
15874130|NCT03849794|Other|Experimental Group|"Chiropractic Care A chiropractor will see participants in the experimental group about 3 times per week using a pragmatic approach for 4 weeks, and each session will be approximately 15-20 minutes in duration. The spinal adjustments performed in this study will be high-velocity, low-amplitude thrusts to the spine, pelvic joints, extremities or instrument-assisted adjustments
~Physiotherapy:
~Physiotherapists will see participants in each group 3 times per week for four weeks. Each session will be approximately 40 minutes in duration. Physiotherapy interventions are likely to include stretches and exercises, massage and mobilization as required."
15874131|NCT03849794|Other|Control group|The control group will receive the same physiotherapy intervention as the experimental group at the same frequency of care. The control group will also attend three passive movement sessions with the chiropractor each week, primarily to minimise the psychological effect of the interaction with the chiropractor, but also to act as a physiological control. These passive movement sessions will be 15 minutes in duration.
15874132|NCT03849781|Device|NeoBeat with a visible display|NeoBeat (Laerdal Medical) is a CE approved novel heart rate meter, able to detect heart rate in newborns within seconds of birth. The NeoBeat uses ECG dry-electrodes in a snug-fit abdomen-shaped buckle for rapid application around the newborn's abdomen or thorax. It allows healthcare providers to reliably assess heart rate of the newborn immediately after birth and continuously during resuscitation.
15874133|NCT03849768|Drug|HS-10296|Drug: HS-10296 110 mg/55 mg + placebo The initial dose of HS-10296 110 mg once daily can be reduced to 55 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
15874134|NCT03849768|Drug|Gefitinib|Drug: Gefitinib 250 mg + placebo The initial dose of Gefitinib 250 mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
15874135|NCT03849755|Device|PEPPER system|The PEPPER system offers insulin dosing advice that is highly adaptive to the insulin needs of individuals by using Case-Base Reasoning (CBR) approach.
15874136|NCT03849742|Other|Quality-of-Life Assessment|Ancillary studies
15874137|NCT03849742|Other|Questionnaire Administration|Ancillary studies
15874138|NCT03849742|Procedure|Supportive Care|Receive Uber rides
15874139|NCT03849729|Drug|Phentermine|This is a randomized, control trial to investigate the effect and safety of Phentermine in patients with obesity who need a bariatric surgery (BMI >35 kg/m2 with comorbidities or BMI > 40 kg/m2).
15874140|NCT03849729|Other|Placebo|his is a randomized, control trial to investigate the effect and safety of Phentermine in patients with obesity who need a bariatric surgery (BMI >35 kg/m2 with comorbidities or BMI > 40 kg/m2).
15874141|NCT03849716|Other|Blood sample|Blood samples obtained for biomarker analyses
15874142|NCT03849716|Other|Cheek swab|Cheek swab obtained for genetic analysis
15874143|NCT03849703|Behavioral|Full Intervention #1|Participants will receive 10 lessons on a weekly basis per semester for two semesters, for a total of 20 lessons. This Intervention group will receive the coparenting and then romantic relationship curricula. The lessons last between 45-60 minutes and are based on evidence based curricula.
15874144|NCT03849703|Behavioral|Full Intervention #2|Participants will receive 10 lessons on a weekly basis per semester for two semesters, for a total of 20 lessons. This Intervention group will receive the romantic relationship and then coparenting curricula. The lessons last between 45-60 minutes and are based on evidence based curricula.
15874176|NCT03849560|Biological|Grippol® Plus, trivalent (Victoria lineage)|Single intramuscular injection of 0.5 ml (1 dose) of vaccine Grippol® Plus, trivalent (Victoria lineage) into the upper third of the outer surface of the shoulder (the deltoid muscle).
15874145|NCT03849703|Behavioral|Partial Intervention #1|Participants will receive 10 lessons on a weekly basis per semester for two semesters, for a total of 20 lessons. This Partial Intervention group will receive the romantic relationship curriculum and a control curriculum. The lessons last between 45-60 minutes and are based on evidence based curricula.
15874146|NCT03849703|Behavioral|Partial Intervention #2|Participants will receive 10 lessons on a weekly basis per semester for two semesters, for a total of 20 lessons. This Partial Intervention group will receive the coparenting curriculum and a control curriculum. The lessons last between 45-60 minutes and are based on evidence based curricula.
15874147|NCT03849690|Drug|TAK-906|TAK-906 capsules.
15874148|NCT03849690|Drug|Esomeprazole|Esomeprazole capsules.
15874149|NCT03849677|Other|Endothelial function and inflammation|Analysis of endothelial function, oxidative stress
15874150|NCT03849664|Drug|Cytoflavin® solution|Single drip infusion of 20 ml of Cytoflavin® solution in 200 ml of 0.9%NaCl intravenously once a day
15874151|NCT03849664|Drug|Cytoflavin® enteric-coated tablet|2 tablets, orally, with 100 ml of drinking water, 30 minutes before meals, 2 times a day, with an interval of 8-10 hours (but no later than 18:00).
15874152|NCT03849664|Drug|Placebo solution|Single drip infusion of 20 ml of placebo solution in 200 ml of 0.9%NaCl intravenously once a day
15874153|NCT03849664|Drug|Placebo enteric-coated tablet|2 tablets, orally, with 100 ml of drinking water, 30 minutes before meals, 2 times a day, with an interval of 8-10 hours (but no later than 18:00).
15874154|NCT03849651|Drug|Cyclophosphamide|"Cyclophosphamide is a nitrogen mustard derivative. It acts as an alkylating agent that causes cross-linking of DNA strands by binding with nucleic acids and other intracellular structures, thus interfering with the normal function of DNA.
~intravenously (IV) once daily (QD) on day -9"
15874155|NCT03849651|Biological|Fludarabine|"Fludarabine phosphate is a synthetic purine nucleoside analog. It acts by inhibiting DNA polymerase, ribonucleotide reductase and DNA primase by competing with the physiologic substrate, deoxyadenosine triphosphate, resulting in inhibition of DNA synthesis.
~fludarabine phosphate IV QD on days -8 to -4"
15874156|NCT03849651|Drug|Thiotepa|Thiotepa is a cell-cycle nonspecific polyfunctional alkylating agent.
15874157|NCT03849651|Drug|Melphalan|"Melphalan, a derivative of nitrogen mustard, is a bifunctional alkylating agent. Melphalan is active against tumor cells that are actively dividing or at rest.
~melphalan IV QD on days -2 to -1"
15874158|NCT03849651|Biological|G-csf|G-csf (granulocytic colony stimulating factor), is a biosynthetic hematopoietic agent that is made using recombinant DNA technology in cultures of Escherichia coli. G-CSF stimulates production, maturation and activation of neutrophils. In addition, endogenous G-CSF enhances certain functions of mature neutrophils, including phagocytosis, chemotaxis and antibody--dependent cellular cytotoxicity.
15874159|NCT03849651|Drug|Mesna|Mesna is a synthetic sulfhydryl (thiol) compound. Mesna contains free sulfhydryl groups that interact chemically with urotoxic metabolites of oxaza-phosphorine derivatives such as cyclophosphamide and ifosfamide. Following glomerular filtration, mesna disulfide is rapidly reduced in the renal tubules back to mesna, the active form of the drug.
15874160|NCT03849651|Device|CliniMACS|Cells for infusion are prepared using the CliniMACS
15874161|NCT03849651|Biological|ATG (rabbit)|"Anti-thymocyte globulin is a purified, pasteurized, gamma immune globulin, obtained by immunization of rabbits with human thymocytes.
~rabbit anti-thymocyte globulin IV daily over 6 hours on days -5 to -3,"
15874162|NCT03849651|Drug|Blinatumomab|"Blinatumomab is a bispecific CD19-directed CD3 T-cell engager that mediates formation of a synapse between T cells and the CD19+ target cell, resulting in lysis of that CD19+ cell.Blinatumomab will be given to patients with a history of CD19+ malignancy as determined by St. Jude hematopathologist review of current and historical specimens and reports.
~blinatumomab IV for 28 days beginning at least 1 week post-DLI"
15874163|NCT03849651|Biological|TCRα/β+|IV on day 0 and may receive an additional dose on day 1
15874164|NCT03849651|Biological|CD19+|IV on day 0 and may receive an additional dose on day 1
15874165|NCT03849651|Biological|CD45RA-depleted DLI|infusion IV
15874166|NCT03849638|Other|Gait training with real time biofeedback|"Patients presenting asymmetry of the kinematic parameters of the step to the evaluation with sensorized treadmill, will undergo gait training program.
~The training program consists of 20 session (1 session/day) of gait training. Daily gait training will last 30 minutes as distributed:
~5 minutes of heating at a comfortable speed for the patient
~Three 5-minute sessions of gait training with biofeedback interspersed with a break of 5 minutes each."
15874167|NCT03849625|Drug|aspirin, NSAIDs, paracetamol|Perform skin test and/or provocation test with aspirin, paracetmol, or suspected NSAIDs in questionable cases
15874168|NCT03849612|Device|AID System|AID system
15874169|NCT03849612|Drug|Insulin Lispro|Individualized doses of insulin lispro administered via the AID system to maintain glycemic control, except during procedures designed to induce hyperglycemia and hypoglycemia.
15874170|NCT03849599|Biological|PRV-300|Treatment
15874171|NCT03849599|Biological|Placebo|Control
15874172|NCT03849573|Behavioral|"OncoTool Intervention (MBSR + HT education)"|OncoTool is a website intended to improve self-management practices for helping cancer patients cope with stress and improve health-related quality of life. OncoTool provides mindfulness-based education and management for dealing with the numerous physical and mental side effects associated with hormone therapy (e.g., muscle and joint pain, vaginal dryness, depressive symptoms). OncoTool is a website designed to improve hormone therapy adherence by improving quality of life, and hormone therapy associated symptom burden. Both intervention and active comparator conditions are administered to participants for 8 weeks.
15874173|NCT03849573|Behavioral|"Oncotool Control (health +HT education)"|OncoTool is a health promotion website with health education on subjects like nutrition and exercise specific to breast cancer survivors, as well as general advice on lifestyle choices and prevention. The Oncotool control has similar HT education content as the experimental content but without the CBT and MBSR state. Both intervention and active comparator conditions are administered to participants for 8 weeks.
15874174|NCT03849560|Biological|Grippol® Quadri|Single intramuscular injection of 0.5 ml (1 dose) of vaccine Grippol® Quadri into the upper third of the outer surface of the shoulder (the deltoid muscle).
15874175|NCT03849560|Biological|Grippol® Plus, trivalent (Yamagata lineage)|Single intramuscular injection of 0.5 ml (1 dose) of vaccine Grippol® Plus, trivalent (Yamagata lineage) into the upper third of the outer surface of the shoulder (the deltoid muscle).
15874178|NCT03849547|Other|Home Balance training|"Training specially designed for balance ability of chronic ankle instability groups.
~Follow the usual home program provided in clinics."
15874179|NCT03849534|Device|Soft occlusal appliance|According to Best Practice in Sweden the soft occlusal appliance is ranked as gold standard for children with mixed or primary dentition
15874180|NCT03849534|Behavioral|Jaw exercises|The participants do three exercises twice a day. Open and closing mouth against resistance as well as stretch
15874181|NCT03849534|Behavioral|Counseling|The patients are instructed to minimize jaw parafunctions, chewing chewing gum etc, to do exercises, to take pain-killers or NSAIDs etc.
15874182|NCT03849521|Diagnostic Test|MRI|Enhanced carotid calcification presented by UTE MR.
15874183|NCT03849508|Drug|Norepinephrine|"Drug: Norepinephrine Norepinephrine tartrate variable infusion with a starting rate of 0,1μg/kg/min (equivalent to norepinephrine base of 0.05 μg /Kg/min).
~Other name: Noradrenaline
~Drug: Hyperbaric Bupivacaine will be injected in the subarachnoid space with a dose of 8 to 12 mg adjusted according to height
~Drug: Sufentanil will be injected in the subarachnoid space with a dose of 2,5μg
~Drug: Morphine will be injected in the subarachnoid space with a dose of 100 μg"
15874184|NCT03849508|Drug|Phenylephrine|"Drug: Phenylephrine variable infusion with a starting rate of 0,5μg/kg/min
~Drug: Hyperbaric Bupivacaine will be injected in the subarachnoid space with a dose of 8 to 12 mg adjusted according to height
~Drug: Sufentanil will be injected in the subarachnoid space with a dose of 2,5μg
~Drug: Morphine will be injected in the subarachnoid space with a dose of 100 μg"
15874185|NCT03849495|Drug|CKD-370|Test drug
15874186|NCT03849495|Drug|D745|Reference drug
15874187|NCT03849482|Diagnostic Test|Multiparametric Magnetic Resonance Imaging|Multiparametric MRI evaluation includes Conventional MRI, Diffusion-Weighted MRI and Dynamic Contrast-Enhanced MRI
15874188|NCT03849482|Diagnostic Test|Fine Needle Aspiration Cytology|Ultrasound-Guided Fine Needle Aspiration Cytology
15874189|NCT03849482|Diagnostic Test|Clinical Evaluation|Patient's history and physical examination, reporting signs and symptoms suggestive of malignancy (pain, facial nerve weakness, fixation to skin and surrounding tissues, trismus, skin ulceration, lymphadenopathy, numbness, weight loss)
15874190|NCT03849482|Diagnostic Test|Final Histopathological Diagnosis|Final Diagnosis of the Disease from the Pathology Report after Surgical Resection of the Lesion
15874191|NCT03849469|Biological|XmAb®22841|Monoclonal bispecific antibody
15874192|NCT03849469|Biological|Pembrolizumab (Keytruda®)|FDA-approved humanized monoclonal antibody
15874193|NCT03849456|Drug|GWP42006|Oral solution containing cannabidivarin 50 milligrams per milliliter (mg/mL) in sesame oil with anhydrous ethanol, sucralose, strawberry flavoring, and β-carotene.
15874197|NCT03849417|Other|ECT|ECT administered as part of normal clinical management
15874198|NCT03849404|Biological|Adalimumab|Patients in AVT02 arm will receive an initial loading dose of AVT02 80 mg (2 × 40 mg) administered subcutaneously (SC), followed by 40 mg given SC once every other week (EOW) starting 1 week after the loading dose, and will continue to receive AVT02 until Week 48 Patients in EU-Humira arm will receive an initial loading dose of Humira 80 mg (2 × 40 mg) administered SC, followed by 40 mg given SC EOW starting 1 week after the loading dose and will continue to receive Humira until Week 48
15874199|NCT03849391|Dietary Supplement|Skate group|This group takes 500 mg/day Skate Skin extract for 12 weeks
15874200|NCT03849391|Dietary Supplement|Placebo group|This group takes 500 mg/day Placebo for 12 weeks
15874201|NCT03849378|Dietary Supplement|Sargassum Horneri Extract group|This group takes 1,000 mg/day of Sargassum Horneri Extract for 12 weeks.
15874202|NCT03849378|Dietary Supplement|Placebo group|This group takes 1,000 mg/day of Placebo Extract for 12 weeks.
15874203|NCT03849365|Drug|TOOKAD VTP|TOOKAD® VTP consists of the combination of a single, 10-minute IV infusion of TOOKAD® at the dose of 3.66 mg/kg, followed by the illumination of the zone to be treated with a 753-nm laser light delivered through transperineal interstitial optical fibers at a power of 150 mW/cm and light energy of 200 J/cm applied over 22 minutes and 15 seconds.
15874204|NCT03849352|Behavioral|Lifestyle changes with the support of health technology|Written instructions will be provided to participants, to include how to download supportive apps on smartphones. Participants will be asked to complete a 3 day food diary using an online platform (MyFood24) prior to attending a face to face consultation which will reinforce the participant's responsibilities. Participants will be assisted to set specific diet and lifestyle goals. 3 fortnightly follow ups will be arranged via 15 minute telephone consultations, three 24 hour dietary diaries will be completed via MyFood24 prior to each fortnightly digital consultation. Participants will be asked to measure their daily activity via a pedometer on their smart phones. Participants will be asked to complete the Godin leisure time questionnaire to assess changes in leisure time exercise.
15874205|NCT03849339|Drug|CKD-387|Test drug
15874206|NCT03849339|Drug|D635|Reference drug
15874207|NCT03849326|Other|Questionnaires|Quality of life Depression Physical pain Social provisions Quality of sleep
15874208|NCT03849326|Biological|blood test|complete blood count and cytokine concentration
15874209|NCT03849326|Other|Maximal effort test|The maximal effort test with VO2max recordings will be assessed during the first visit to the laboratory.
15874210|NCT03849326|Device|actigraphy|assessment of sleep quality
15874211|NCT03849326|Device|Neuromuscular evaluation|"The maximum isometric force produced by the knee extensors will be measured on the ergometer
~the intensity of muscular electrical activity recorded by surface electromyography
~Peripheral nerve stimulation
~Transcranial magnetic stimulation
~Magnetic resonance imaging (optional)"
15874249|NCT03849040|Procedure|Endobronchial Ultrasound|All patients will undergo EBUS-TBNA as per routine care, except for the one difference where the procedures will be video-recorded so that they can be used for computer analysis at a later time. Static images will be obtained from EBUS videos in order to perform segmentation. Segmentation will be conducted by both an experienced endoscopist and NeuralSeg.
15874250|NCT03849027|Drug|Methoxyflurane|Inhaled methoxyflurane will be administered using the disposable field inhaler device (Penthrop®) according to the recommended dosing schedule.
15874212|NCT03849313|Drug|Adalimumab|"AVT02, a proposed similar biological product (biosimilar) of Humira which contains adalimumab . Adalimumab is a recombinant, fully human monoclonal immunoglobulin G1 (IgG1) antibody that binds specifically and with high affinity to the soluble and transmembrane forms of tumor necrosis factor (TNF)-α thereby inhibiting the binding of TNF-α with its receptor, and inhibiting TNF -α's biological function.
~Tumor necrosis factor-α is a naturally occurring cytokine that is key to normal inflammatory and immune responses. Elevated levels of TNF-α are found in the synovial fluid of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis patients and psoriasis plaques and play an important role in both the pathologic inflammation and joint destruction that are hallmarks of these inflammatory diseases"
15874213|NCT03849300|Other|Aquatic walking exercise program group 1|12 week aquatic walking exercise program
15874214|NCT03849300|Other|Aquatic walking exercise program group 2|12 week aquatic walking exercise program
15874215|NCT03849300|Other|Land-based walking exercise group|12 week land-based walking exercise program
15874216|NCT03849287|Drug|CKD-333, formula I|Test drug
15874217|NCT03849287|Drug|CKD-333, formula II|Test drug
15874218|NCT03849287|Drug|CKD-330, D090|Reference Drug
15874219|NCT03849274|Combination Product|Smart Scar Care Pad=Pressure Garment|Smart Scar Care Pad (SSCP) + conventional Pressure Garment in the management of HS in adult with total hip replacement (THR) and total knee replacement (TKR)
15874220|NCT03849274|Device|Pressure Garment|Conventional Pressure Garment (PG) alone in the management of HS in adult with total hip replacement (THR) and total knee replacement (TKR)
15874221|NCT03849261|Drug|CKD-387|Test drug
15874222|NCT03849261|Drug|D635|Reference drug
15874223|NCT03849248|Other|Maternal scent cloth|The babies assigned to the intervention group will have a cloth with their mother's scent on it placed under their heads.
15874224|NCT03849235|Dietary Supplement|Standardised meal or glucagon|Standardised meal (Nutridrink, Nutricia, 300 kcal, 18.4 g carbohydrates, 5.8 g fat, 12 g protein) or 1mg glucagon
15874225|NCT03849222|Procedure|Apexification|
15874226|NCT03849222|Drug|MTA|
15874227|NCT03849222|Drug|Ca(OH)2|
15874228|NCT03849222|Drug|Apical matrix|collagen membrane (Biocollagen; Bioteck:Turin, Italy)
15874229|NCT03849209|Device|Stylet slow-pull technique|During endosonographic examination, the pancreatic mass was evaluated with color Doppler to avoid the involvement of vessels. The needle (20 Gauge, EchoTip ProCore 20G with ReCoil Stylet™, Cook Medical, Bloomington, IN, USA) was sharpened by withdrawing the stylet approximately 2 mm, and then was advanced into the lesion: 15 to-and-fro movements within the lesion were performed, with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously.
15874230|NCT03849209|Device|Standard suction technique|During endosonographic examination, the pancreatic mass was evaluated with color Doppler to avoid the involvement of vessels. The needle (20 Gauge, EchoTip ProCore 20G with ReCoil Stylet™, Cook Medical, Bloomington, IN, USA) was sharpened by withdrawing the stylet approximately 2 mm, and then was advanced into the lesion: 15 to-and-fro movements within the lesion were performed using a 10-mL suction syringe.
15874231|NCT03849196|Drug|2L PEG-Asc|PEG-Asc powder
15874232|NCT03849196|Drug|Bisacodyl 10Mg Suppository|bisacodyl 10 mg suppository
15874233|NCT03849196|Drug|1L PEG-Asc|PEG-Asc powder
15874234|NCT03849183|Drug|Nitroglycerin|Subcutaneous nitroglycerin injection to increase the first attempt success rate of radial artery cannulation in pediatric patients
15874235|NCT03849183|Drug|Normal saline|Subcutaneous normal saline injection to increase the first attempt success rate of radial artery cannulation in pediatric patients
15874236|NCT03849170|Behavioral|Stress Inoculation Technique|Teaches athletes to use cognitive-behavioral techniques to reduce their stress response during sporting events.
15874237|NCT03849170|Other|Health Intervention|Will provide basic dietary and lifestyle guidelines that athletes should follow in their daily lives to maintain their health
15874238|NCT03849157|Procedure|pelvic floor reconstructive surgery|transvaginal mesh implantation for pelvic organ prolapse
15874239|NCT03849144|Behavioral|Therapy dog activity|Visiting therapy dogs and their owners, evaluated and registered as therapy dog teams with Pet Partners will be spread around a large room on the Aetna campus. Employees will arrive at scheduled times to visit with the dogs for 15 minutes, talking to the dogs and owners and petting the dogs
15874240|NCT03849144|Behavioral|Low impact exercise|The low impact exercise will consist of stretching exercises conducted by a member of Aetna's wellness team in the same room for 15 minutes.
15874241|NCT03849131|Biological|Biological collection|"Blood samples will be collected only once at enrollment, before initiation of a checkpoint inhibitor.
~It will include:
~DNA samples collection
~RNA samples collection
~Blood sample collection"
15874242|NCT03849118|Diagnostic Test|89Zr-girentuximab|Single IV administration on Day 0, followed by diagnostic scan on Day 5 +/- 2 days.
15874243|NCT03849105|Radiation|4-L-[131I]iodo-phenylalanine (131I-IPA)|"Study participants will receive by intravenous infusion an escalating activity of 4-L-[131I]iodo-phenylalanine (131I-IPA).
~Additional therapy is received in the form of externally administered radiotherapy"
15874244|NCT03849092|Behavioral|Financial incentives|Cessation programs in municipalities will offer a financial incentive of 1200 DKK to smokers who achieve continuous abstinence from smoking when attending a group-based smoking cessation program. Aimed at smokers with low socioeconomic status but other smokers are also included.
15874245|NCT03849092|Behavioral|Campaigns|Municipalities will design anti-smoking campaigns targeting smokers, recommending to use a municipal free group-based smoking cessation program. Aimed at smokers with low socioeconomic status but other smokers are also included.
15874246|NCT03849079|Other|Hyponut|Prick tests with hyponut
15874247|NCT03849066|Other|Parent-Reported Symptom Assessment|As the basis for PRSA, the investigator will use the PediQuest Memorial Symptom Assessment Scale (PQ-MSAS), which is an adapted pediatric-specific version of the validated adult MSAS that assesses 24 physical and psychological symptoms over the past week. The study instrument is designed to be completed by a full-proxy parent, and 2 versions tailored for specific age groups are available (0-3, 3-18 years-old). Spanish versions are available for both instruments. The PQ-MSAS contains 24 symptom items, each with 4-point scores for domains of frequency, severity, and extent of bother. Based on these components, a global symptom score and individual symptom scores can be calculated (0-100 scale, with 100 being the worst).
15874275|NCT03848780|Drug|Desflurane|
15874251|NCT03849027|Drug|Placebo|The sham inhaler will have one droplet of methoxyflurane applied to the outer surface, but no drug in the vaporization chamber to give off the prominent odour with no analgesic effect, partially blinding the participants to the test.
15874252|NCT03849014|Procedure|Dynamic Hip Screw|Dynamic Hip Screw fixation: Fracture will be reduced under image intensifier. The incision will be made 7-10 cm with a lateral approach. The fascia lata will be incised and the vastus lateralis muscle will be splited along the axis of the femur, without stripping the periosteum. A135° angle guide will be inserted in the lower half of the femoral neck. The barrel of the plate will be guided to the hip screw by direct palpation to minimize the soft-tissue injury. After the insertion of the cortical screw, soft tissue will be protected with 4.5mm drill sleeve during drilling and tapping.
15874253|NCT03849014|Procedure|Proximal Femoral Nail|Proximal Femoral Nail fixation: Fracture will be reduced under image intensifier. The incision 2-3 cm with a lateral approach that extended from the cranial part to the tip of the greater trochanter. After palpating the greater trochanter tip, the nail will be then introduced manually into the femoral shaft. The guide wire of the anti-rotational hip blade then introduced. The hip blade should be introduced in the direction of the lower half of the femoral neck. Drilling will be performed under soft-tissue protection with a retractor. The blade will be inserted, and a distal static locking screw and end cap will be inserted under soft tissue protection with a drill sleeve.
15874254|NCT03849001|Behavioral|Exercise Conditions|Light Exercise
15874255|NCT03849001|Behavioral|Exercise Conditions|Moderate Exercise
15874256|NCT03849001|Behavioral|Exercise Conditions|Vigorous Exercise
15874257|NCT03849001|Behavioral|Exercise Conditions|Seated Rest
15874258|NCT03848975|Other|Simulation training for ECV|Intervention for the ECV group is a ECV simulation training. The group will have theoretical courses and five simulation sessions with four ECV simulation on a model (i.e., a total of 20 ECV), associated with clinical practice in the delivery room.
15874259|NCT03848975|Other|Simulation training for VE|Intervention for the VE group is a simulation training. The group will have theoretical courses and five simulation sessions with four VE simulation on a model (i.e., a total of 20 VE), associated with clinical practice in the delivery room. The investigators will us Kiwi® Omni Cup Vacuum Delivery System, as this is the vacuum system chosen for clinical practice in our obstetric service.
15874260|NCT03848949|Device|Evenup|Orthotic which increases effective leg length.
15874261|NCT03848936|Other|Survey|Survey includes age, gender, cerebral palsy type, education, mental status, working status, living conditions, comorbidities, pain, spasticity, contractures, deformities, mobility status and gross motor function classification system level
15874262|NCT03848910|Device|Investigational device - Sound Processor|"At visit 1 the subjects will complete self-reported assessments with respect to pre-study experience using precursor Sound Processor (comparator). At visit 1 the subjects will then receive the Investigational device (Sound Processor) which should be used during the following 6 weeks. At visit 3 the subjects will complete self-reported assessments regarding Investigational device and participate in audiology tests regarding both Sound Processors, comparator and Investigational device. The subject shall decide their preferred choice made by selection between Investigational device and the comparator."
15874263|NCT03848897|Other|Metrology of motor behavior|Biomechanical, physiological, psychological and behavioral analyses
15874264|NCT03848884|Behavioral|Adherence monitoring and education|Standardized medication counseling and education combined with individual patient customized guidance and counseling - administered monthly.
15874265|NCT03848871|Drug|Enstilar|Enstilar foam applied to affected area once daily
15874266|NCT03848858|Behavioral|EMDR plus TAU|The standard EMDR protocol will first be applied, consisting of 8 phases: 1) Patient history; 2) Patient preparation; 3) Evaluation of the main aspects of the traumatic memory; 4) Desensitization of the memory; 5) Installation of the positive cognition; 6) Body scan; 7) Close and 8) Reevaluation. The specific protocol for the sequelae of somatic illness and medical trauma is next applied. It first focuses on processing past memories related to diagnosis, symptom development, medical procedures and unjust or stressful behaviour with the medical system. Once these are processed, the intervention addresses current symptoms, impairments and triggers. Finally, the patient is helped to face the future and reduce avoidance of medical procedures, avoidance of social life and fear of dying.
15874269|NCT03848832|Drug|GWP42003-P|GWP42003-P presented as an oral solution containing cannabidiol in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
15874270|NCT03848832|Drug|Placebo|Placebo oral solution containing the excipients sesame oil and anhydrous ethanol with added beta-carotene, sweetener (sucralose) and strawberry flavoring.
15874271|NCT03848819|Device|VitaBreath device|The VitaBreath (Philips, Respironics) is a portable, handheld, battery powered, non-invasive ventilation device, that has been shown by our group to reduce activity-related shortness of breath in patients with COPD. It delivers 18 cmH2O inspiratory and 8 cmH2O expiratory pressures, but can only be used during recovery periods. In our study patients will perform consecutive bouts of exercise alternated by two minute of recovery in order to allow the use of the VitaBreath device during the first minute of each recovery period.
15874272|NCT03848806|Drug|HAT1|During the treatment phase, patients will be ask to apply the product twice daily on all lesional areas. The research team will provide instructions for the correct application of the treatment. If a lesion disappears, patients will continue applying the cream twice daily to the area. No additional creams, lotions or soaps other than provided test products will be allowed throughout the duration of the study.
15874273|NCT03848806|Drug|Calcipotriol|During the treatment phase, patients will be ask to apply the product twice daily on all lesional areas. The research team will provide instructions for the correct application of the treatment. If a lesion disappears, patients will continue applying the cream twice daily to the area. No additional creams, lotions or soaps other than provided test products will be allowed throughout the duration of the study.
15874274|NCT03848793|Drug|HS-20004|treatment
15874277|NCT03848767|Drug|Insulin Lispro|Individualized doses of insulin lispro administered via the AID system to maintain glycemic control except during meal challenges.
15874282|NCT03848741|Behavioral|Non-Exercise Control|Participants will not perform structured exercise and will continue with their normal physical activity for 12-weeks.
15874283|NCT03848741|Behavioral|Resistance Exercise Training|Participants will complete a 12-week whole-body progressive resistance exercise training program.
15874284|NCT03848741|Dietary Supplement|Placebo|Participants will be given placebo capsules to consume for 12-weeks.
15874285|NCT03848741|Dietary Supplement|HMB+VitD|Participants will be given HMB+VitD capsules to consume for 12-weeks
15874286|NCT03848728|Other|SEARCH Youth combination intervention|"Administration of life-stage assessment tool
~Structured choice clinic access
~Rapid feedback of VL results
~Provider e-collaboratives with chat groups for discussions of challenging cases using de-identified information"
15874287|NCT03848715|Biological|Endotoxin|Endotoxin
15874288|NCT03848715|Biological|Placebo|Placebo
15874289|NCT03848702|Device|Distal radius fracture brace|The distal radius fracture brace is constructed from biocompatible materials (like polylactic acid; PLA) and the skin is protected by commercially available and approved waterproof padding (like Aquacast®). The major brace components are connected and reinforced with carbon rods and plastic bolt-nut connections. PLA is extensively used, for example in surgical implants, but also as biological alternative for plastics. Aquacast® is approved and used as waterproof padding in swim plaster. The biomechanical function of the distal radius brace has been tested successfully in an ex vivo setting (results to be published). The DRFB includes the distal forearm, wrist an base of the hand. The thumb and fingers are free and the DRFB provides more movement than classical casting.
15874290|NCT03848689|Other|fluoroquinolone preprescription authorization|Requires authorization from Infection Control consult prior to prescribing fluoroquinolone
15874291|NCT03848689|Other|Control|Does not require authorization from Infection Control prior to prescribing fluoroquinolone
15874292|NCT03848676|Diagnostic Test|Evaluation of patients resistance to immunotherapies in Multiple Myeloma|There are only collections of the samples.
15874293|NCT03848663|Behavioral|Traditional Remapping|Shifting text outside of scotoma
15874294|NCT03848663|Behavioral|Personalized Remapping|Shifting text based on individual letter-based perimetry
15874295|NCT03848650|Device|OpSens Medical OptoWire|"The OptoWire is FDA approved to measure pressure in coronary vessels during diagnostic angiography and coronary interventions.
~The OptoWire Deux pressure wire (OpSens Medical, Quebec, Canada) is a novel technology utilizing optical coherence technology to enhance FFR assessment of the coronaries."
15874296|NCT03848650|Procedure|FFR|A guide wire-based procedure that can accurately measure blood pressure and flow through a specific part of the coronary artery. FFR is done through a standard diagnostic catheter at the time of a coronary angiogram (a.k.a. cardiac catheterization).
15874297|NCT03848637|Drug|CKD-375|Test drug
15874298|NCT03848637|Drug|D387|Reference drug
15874299|NCT03848624|Device|Cycling Group|Electrical pulses from a stimulator can stimulate the target muscles to generate muscle contraction to support a continuous cycling motion
15874300|NCT03848611|Drug|CM082 plus JS001|CM082：150mg once a day (qd) orally (taken within half an hour after breakfast). JS001 :An intravenous infusion of a solution having a concentration of 1-10 mg/ml was prepared with 0.9% physiological saline, and administered once every two weeks. Using an inline filter (0.2 or 0.22 μm), the drug was diluted with physiological saline and intravenously administered within 60 minutes.
15874301|NCT03848598|Diagnostic Test|Evaluation of local tendon deformation|Ultrasound-based speckle tracking to evaluate the local tendon tissue displacement during isometric exercise.
15874302|NCT03848585|Device|Pilloxa Pillbox|A Pilloxa Pillbox is used for the prescribed immunosuppressants.
15874303|NCT03848585|Other|Non active Pilloxa Pillbox|A Pilloxa Pillbox with reminders disabled and without active mobile application is used for the prescribed immunosuppressants.
15874304|NCT03848572|Diagnostic Test|Repetitive assessment of PRECISE-DAPT score|The PRECISE-DAPT score, which takes into consideration age, creatinine clearance, haemoglobin, white blood-cell count and previous spontaneous bleeding, will be reassessed every 3 months during the 12-month follow-up period
15874305|NCT03848559|Device|Airway management with a submerged model|Airway management with a submerged manikin using different airway devices in randomized order
15874306|NCT03848546|Behavioral|PDA|"Subjects receive personal dietary fiber advice to increase their fiber intake. This advice will be provided using an online web-portal, where subjects can choose high-fiber alternatives that closely match their own intake. The aim is to swap product for low in fiber for a high fiber alternative (such as white bread, whole wheat bread)."
15874307|NCT03848546|Other|Control (no intervention)|No intervention
15874308|NCT03848533|Drug|melatonin|"The administration of melatonin will be indicated at night before bedtime to avoid alterations of the circadian cycle. It will be contained in bottles labeled Medication 2 to maintain the masking. This intervention will be indicated in two groups (Melatonin plus metformin and Melatonin plus placebo)"
15874309|NCT03848533|Drug|metformin|"For the intervention with metformin, prolonged-release tablets will be used to reduce adverse effects and improve adherence to treatment. It will be contained in bottles labeled Medication 1 to maintain masking. This intervention will be indicated in two groups (Melatonin plus metformin and metformin plus placebo)"
15874310|NCT03848533|Drug|Placebo|"The placebo may be contained in bottles labeled Medication 1 or Medication 2 depending on the time of administration, and the group in which it is used. Placebo will be used in two groups (Melatonin plus placebo and Metformin plus placebo)"
15874311|NCT03848520|Procedure|TKA|TKA performed in the past
15874313|NCT03848494|Procedure|Surgery|Laparoscopic floppy Nissen, laparoscopic-left thoracoscopic Collis-Nissen, laparoscopic gastric fundus wrapped around the stomach
15874314|NCT03848481|Drug|CBDV Compound|CBDV is obtained from the Cannabis sativa L. plant and contains a negligible quantity (less than 0.2%) of THC
15874315|NCT03848481|Drug|Placebo|Placebo oral solution contains matching excipients.
15874316|NCT03848468|Procedure|Hemorrhoidectomy|excision of 3rd and 4th degree hemorrhoids
15874317|NCT03848455|Diagnostic Test|genetic diagnosis|The venous blood of the two groups of patients was taken for genetic testing, and the expression levels of PPP2CA, PPP3CB, SYNJ1, NSF and CYCS were extracted by pre-processing the genetic data of PD and non-PD patients.
15874318|NCT03848442|Other|'Uptime' participation|The intervention are designed for each individual and are consistent with the model for participation-based interventions. The interventions are goal-oriented (meaningful and family/client-selected goals), family/client-centered (promoted self-determination and decision making), collaborative (partnership between caregivers), strength-based (built on participant and caregiver strengths) and ecological (natural environment and real-life experiences). Design of the intervention comprised three steps: 1) Preparation period (6 weeks); 2) Intervention period (12 weeks); 3) Follow-up period (12 weeks)
15874319|NCT03848429|Procedure|Surgery for mechanical complications of acute myocardial infarction|Surgical treatment of post-AMI left ventricular free-wall rupture: sutured and sutureless repair. Surgical treatment of post-AMI ventricular septal defect: infarctectomy and infarct exclusion repair. Surgical treatment of post-AMI papillary muscle rupture: mitral valve repair and replacement
15874320|NCT03848416|Biological|Ixekizumab|Administered SC
15874321|NCT03848403|Biological|Ixekizumab|Administered SC
15874322|NCT03848390|Behavioral|Conventional diet|The conventional diet arm will be asked to consume a hypocaloric diet, and they will be allowed to eat at any time of the day with no time restriction.
15874323|NCT03848390|Behavioral|Modified Time-restricted Feeding|The modified time-restricted feeding arm will be asked to consume any food but will be asked to consume this food for only a 9 hour daytime period.
15874324|NCT03848390|Behavioral|Physical activity|At least 30 minutes of physical activity per day 5 times per week.
15874325|NCT03848390|Behavioral|Restricted consumption of sweetened beverages|Restricted consumption of juice, soda, and other sweetened beverages.
15874326|NCT03848364|Behavioral|Hip Hop Stroke 2.0|HHS2.0 is an innovative, multimedia program, a brief 3-hour (1hr/day for 3 days), school-based intervention designed to educate at-risk populations concerning stroke symptoms and calling 911 immediately in the event they occur (stroke literacy). HHS2.0 is accessed and delivered via a web link online as self-administered, interactive modules that target 4th and 5th grade children in the school system (ages 9-11) using narrative cartoons and multimedia games.
15874327|NCT03848351|Behavioral|Oral Hygiene Instruction (OHI)|OHI will be given focusing on electric toothbrushing as first instance and subsequently focusing on interdental cleaning. OHI will be delivered by trained dental hygienist/periodontist. In the first phase the clinician will explain and show the technique to the patient. The patient will be then invited to perform the technique. Each phase will be assisted and monitored by the clinician. Overall, this sequence may be repeated as many times as the clinician would deem appropriate.
15874328|NCT03848351|Procedure|Professional supragingival scaling and polishing|Patients will receive a session of professional supragingival scaling and polishing, that consists of removal of dental plaque and dental calculus from the surface of a tooth, with great care in performing exclusively coronal maneuver. No instrumentation or exploring of the gingival crevice/ sulcus will be performed. Instrumentation will be performed by a trained dental hygienist/periodontist.
15874329|NCT03848338|Procedure|Electrocochleography|Electrocochleography measurement Intra-operatively and Post-operatively at follow-up appointments along with correlative measurements (Impedance, eCAP, PTA, Speech)
15874330|NCT03848325|Behavioral|Sleep deprivation|Eight hour opportunity for sleep followed by 24 hours of sleep deprivation.
15874331|NCT03848312|Behavioral|Cognitive Training|Participants will be completing a total of 45 computerized sessions.
15874332|NCT03848312|Behavioral|Computerized Cognitive Stimulation|Participants will be completing a total of 45 computerized cognitive stimulation sessions.
15874333|NCT03848299|Other|Experimental: Single Arm|"All participants will have to consume the same standardized breakfasts from the second to the seventh day, except the ones that are intolerant or allergic to lactose or/and gluten. In those cases, they will follow an adapted diet for their intolerance or allergies.
~Day 2 and 3: 110 g white bread.
~Day 4 and 5 : 110 g white bread and 30 g butter or 55 g white bread, 50 g dark chocolate for lactose intolerant.
~Day 6 and 7: Glucose drink (50g).
~The bread will be replaced by gluten-free bread for gluten intolerant participants."
15874334|NCT03848286|Drug|KL-A167 Injection|KL-A167 900 mg intravenously (IV) every-2-weeks (Q2W)
15874335|NCT03848260|Device|Magnetic device prototype|The device prototype comprises a near-infrared light-emitting diode (SMT910, Epitex Inc, Kyoto, Japan) and receiver (PD15-22C TR8, Everlight Electronics Corporation, New Taipei City, Taiwan), a permanent electromagnetic actuator (JNP-12/12, Joint Magnetic Technology Corporation, Shenzhen, China), an iron sheet affixed to the paralytic upper eyelid, and a bio-signal acquisition module. The efficacy and safety of the device prototype was assessed using the device prototype.
15874336|NCT03848247|Other|Injection of Isotonic saline|Half the participants will be injected in a neck muscle with isotonic saline (Control group) and the other half will get NGF (Neck pain group).
15874337|NCT03848247|Other|Injection of NGF|Half the participants will be injected in a neck muscle with NGF (Neck pain group).
15874338|NCT03848234|Drug|Estradiol|2 trans dermal patches to be changed twice a week for the duration of 8 weeks.
15874339|NCT03848234|Device|Placebo|2 trans dermal patches to be changed twice a week for the duration of 8 weeks.
15874340|NCT03848221|Drug|Systane Complete|Systane Complete is an artificial tear.
15874341|NCT03848221|Drug|Sensitive Eyes Rewetting Drops|Sensitive Eyes Rewetting Drops is a rewetting drop.
15874342|NCT03848208|Drug|cytisine|cytisine film-coated oral tablet
15874343|NCT03848208|Drug|placebo|matching placebo oral tablet
15874344|NCT03848182|Drug|Gemcitabine|Gemcitabine will be administered on days 1, 8, 15 every 28 days
15874345|NCT03848182|Biological|TT vaccine booster|One human TT childhood vaccine booster will be administered on day 8
15874346|NCT03848169|Other|Radiofrequency|See previous page
15874348|NCT03848143|Drug|onabotulinum toxin A|Each subject will receive 50 units (50 U) of BoNT-A constituted in 1 mL of saline solution injected intraorally to the painful area divided in at least 3 sites, 0.5 to 1.0 cm apart depending on the size of the painful area and following a checkerboard pattern.
15874349|NCT03848130|Other|Mulligan Knee Taping with Home Exercises|Each patient in group I i.e. taping group with home exercises was given 40 minutes session. Each session started in sitting or lying position with leg extended and mulligan tape was used. Taping was started in the middle of patella, at the level of superior aspect of patella and pulled the tape medially and fixed the tape at medial border. This tilts the lateral border of patella away from femur and produced skin wrinkling. Besides this, home exercises such as quads isometrics and self stretchings & ROMs were also guided. This session was repeated three times a week for one month (Total 12 sessions/ one month).
15874350|NCT03848130|Other|Lateral wedge insoles with Home Exercises|Each patient in group II i.e. lateral wedge insole with home exercises group was given 20-minute session. In each session, Lateral wedge insoles of 7mm made of silicon or ledos material were advised and home exercises in the same way. This session was repeated once a month but evaluations were obtained after a complete week for one month. (Total 4 sessions/one month)
15874351|NCT03848130|Other|Traditional Physiotherapy with Home Exercises|Each patient in group III i.e. traditional physiotherapy with home exercises group was given 40 to 45-minute session. Each session started in lying position. In each session, therapeutic ultrasound with 1.5MHz frequency and continuous mode for 7 minute was given. Then passive stretchings of the following muscle groups was done; calf, hamstring, quadriceps, hip flexors and hip adductors & abductors and followed by strengthening exercises manually and with quadriceps bench. Home exercises were guided in the same way. This session was repeated 3 to 4 times a month. (Total 12 to 16 sessions/ one month)
15874352|NCT03848117|Other|Cyriax approach i.e. DTF massage and Mill's manipulation|Each patient in group I i.e. Cyriax group was given 20-minute session. Each session started in sitting position and initially deep transverse friction massage was done at lateral compartment of the elbow joint and immediately after that mill's manipulation at elbow joint with flexion at wrist joint in pronated arm position. This session was repeated three times a week for one month (Total 12 sessions/ one month).
15874353|NCT03848117|Other|Mulligan approach i.e. Taping and MWM|Each patient in group II i.e. Mulligan group was given 30 to 45-minute session. Each session started in sitting position and it included mobilization with movement which was given in such a way that initially lateral glide at elbow joint was performed and after holding it, I asked the patient to make a fist and open the fist. In this way, I repeated this procedure 36 times and after 12 repetitions, a short rest period was given. Taping was applied after mobilization around the elbow joint over extensor carpi radialis muscles. This session was repeated three times a week for one month (Total 12 sessions/ one month).
15874354|NCT03848104|Other|bone and joint infection treated with cefoxitin|the patients had cefoxitin in combination in continuous parenteral administration to treat their bone / joint infection
15874355|NCT03848091|Other|Antibiotic pretreatment|a strategy with antibiotic pretreatment before one-step exchange arthroplasty in patients who bacteria responsible for the infection has been indentified (puncture, blood cultures,...)
15874356|NCT03848078|Device|Optical Coherence Tomography|"OCT is an imaging technique, which is able to produce real-time, in vivo, cross-sectional images of lesions with a depth of 1,5-2 mm. OCT imaging is based on light-interferometry, calculating the interference of an optical beam reflected by the tissue with a reference. In such ways, microscopic details of lesions and tissues can be visualized. This information can be used to identify a lesion as BCC, and to specify the subtype. Therefore, we assume that the use of the OCT might reduce the number of biopsies and the accompanying morbidity.
~The investigator scans 6mm of skin with the OCT (30 seconds) and decides whether the lesion is a BCC or not."
15874357|NCT03848065|Biological|V114|15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.
15874358|NCT03848065|Biological|Pneumococcal 13-valent Conjugate Vaccine (PCV13)|13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B in each 0.5. mL dose.
15874359|NCT03848039|Biological|Gardasil-9|administration by intramuscular injection of the 9-valent HPV vaccine according to a 3-dose vaccination schedule (0, 2, 6 months).
15874360|NCT03848039|Drug|Placebo|administration by intramuscular injection of the placebo according to vaccination schedule of the 9-valent HPV vaccine (0, 2, 6 months)
15874361|NCT03848026|Other|Middle ear fluid viscosity|The patients were subdivided into two groups according to median viscosity level
15874362|NCT03848026|Other|Tympanostomy tube extrusion time|Tympanostomy tube extrusion time of the all patients recorded prospectively.
15874363|NCT03848013|Device|Q switched Nd YAG laser|Laser device emitting Q switched Nd YAG aiming for skin toning
15874364|NCT03848013|Device|Fractional CO2 laser|Laser device emitting fractionated ablative laser aiming for skin resurfacing
15874365|NCT03848000|Other|Exercise Programme|Two sessions per week for 12 consecutive weeks. 30 minute education talks covering topics regarding the physical and mental health benefits of exercise and behaviour change. The following 30-60 minute exercise sessions will utilise pad-boxing, football, body-weight training and circuit training.
15874366|NCT03848000|Behavioral|NHS Standard Care|Weekly one-to-one cognitive-behavioral counselling alcohol addiction support session lasting 1 hour. Drug therapy will be offered if indicated in line with standard therapy.
15874367|NCT03847987|Drug|RO7017773 Phase I Capsule|Participants will receive 1 single oral dose of RO7017773 Phase I Capsule.
15874368|NCT03847987|Drug|RO7017773 Phase II Tablet Unflavored|Participants will receive 3 single oral doses of unflavored RO7017773 Phase II tablet during Part 1, and 1 single oral dose of unflavored RO7017773 Phase II tablet during Part 2.
15874369|NCT03847987|Drug|RO7017773 Phase II Tablet Sweetened/Flavored|Participants will receive 1 single oral dose of sweetened/flavored RO7017773 Phase II tablet during Part 2.
15874370|NCT03847974|Drug|LIB003|300 mg SC Q4W
15874404|NCT03847766|Behavioral|PRO-based telephone consultation|diagnose-specific questionnaires are used to support communication between clinician and patient during a phone consultation
15874405|NCT03847753|Other|Organic Disorders|Individuals were considered to have a specific mental disorder from the date they received a relevant diagnosis registered in the Danish Psychiatric Central Research Register.
15874371|NCT03847961|Device|hemoperfusion with cytokine adsorption column (CA330)|Hemoperfusion treatments are performed using a perfusion machine via centrally inserted standard dialysis catheters at a prescribed blood flow rate of 100-300ml/min. In the beginning, lower flow rate is recommended, if there is no discomfort, then gradually increases. Each patient received 2 hemoperfusion treatments within 24 hours with a target duration for each treatment of 120-180 minutes (minimum of 120 minutes). The shorter the interval between the two hemoperfusion is, the better. It is suggested that the second hemoperfusion be performed within 0-5 hours after the first one.
15874372|NCT03847935|Procedure|surgery|A1 pulley release of finger
15874373|NCT03847935|Procedure|corticosteroid injections|corticosteroid injection to A1 pulley
15874374|NCT03847935|Other|Hand Therapy|orthosis fabrication, therapeutic exercise for range of motion to digits, ice massage, nodule massage, patient education,
15874375|NCT03847935|Other|Modality Hand Therapy|orthosis fabrication, therapeutic exercise for range of motion to digits, ice massage, nodule massage, patient education, plus modalities such as ultrasound, iontophoresis
15874376|NCT03847922|Drug|Nitrous Oxide + Oxygen Gas (Product)|Self-administered 50% nitrous oxide / 50% oxygen mixture will be given to the intervention group, starting just before the beginning of the urethral bulking procedure.
15874377|NCT03847922|Drug|lidocaine gel 2%|6mL of 2% lidocaine gel will be inserted and injected into the urethral canal approximately 10 minutes prior to the procedure for each participant regardless of group assignment.
15874378|NCT03847922|Other|Room air|Room air will be administered via the Pro-Nox machine to participants in the control group, starting just before the beginning of the urethral bulking procedure.
15874379|NCT03847909|Drug|DCR-PHXC|Multiple fixed doses of DCR-PHXC by subcutaneous (SC) injection
15874380|NCT03847909|Drug|Sterile Normal Saline (0.9% NaCl)|Sterile Normal Saline (0.9% NaCl) for subcutaneous (SC) injection, administered at same injection volume as DCR-PHXC, to serve as placebo
15874381|NCT03847896|Combination Product|Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg|Budesonide/albuterol sulfate combination inhalation aerosol
15874382|NCT03847896|Combination Product|Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg|Budesonide/albuterol sulfate combination inhalation aerosol
15874383|NCT03847896|Combination Product|Budesonide metered-dose inhaler 160 µg|Budesonide inhalation aerosol
15874384|NCT03847896|Combination Product|Albuterol sulfate metered-dose inhaler 180 μg|Albuterol sulfate inhalation aerosol
15874385|NCT03847896|Combination Product|Placebo metered-dose inhaler|Placebo inhalation aerosol administered 4 times daily
15874386|NCT03847883|Drug|Intravenous Solution Ateplase|Infusion Low dose 0.6 or 0.75 or 0.9 mg/kg Ateplase injection iv bolus 10% of total dose and infusion 90% of total dose in1 hour , with in 4.5Hr after onset of stroke
15874387|NCT03847870|Diagnostic Test|MORU in-house ELISA test followed by IFA if positive|An in-house rickettsial IgG ELISA test will be used for this study to determine previous rickettsial infections by measuring IgG levels. All specimens will be tested for IgG antibodies using ELISA tests for scrub typhus (Orientia tsutsugamushi strains Karp, Kato, Gilliam and TA716), murine typhus (Rickettsia typhi strain type Wilmington), and spotted fever rickettsiosis (Rickettsia honei and Rickettsia conorii). If the sample tests positive, it will be retested for the same antigens using the IFA test. The sample will be considered positive if both the ELISA and the IFA are positive.
15874388|NCT03847857|Biological|Porcine Fibrin Sealant (PFS)|McKeown esophagectomy will be performed for patients with resectable thoracic esophageal carcinoma or gastroesophageal junction cancer. At last, 2.5ml Porcine Fibrin Sealant will be instilled over the cervical anastomose line.
15874389|NCT03847857|Procedure|McKeown esophagectomy|McKeown esophagectomy including open or minimally invasive esophagectomy will be performed for patients with resectable thoracic esophageal carcinoma or gastroesophageal junction cancer. Two-field lymphadenectomy with total mediastinal lymph node dissection is performed during surgery.
15874390|NCT03847844|Biological|Umbilical cord derived mesenchymal stem cell|Umbilical cord derived mesenchymal stem cell
15874391|NCT03847844|Other|Placebo|Normal saline
15874392|NCT03847831|Behavioral|Active School Flag Program|Schools enrolled in the program take part in the 17 actions described in the PPASF.
15874393|NCT03847818|Drug|Pyrotinib+Trastuzumab+Docetaxel+Carboplatin|"Drug: Pyrotinib Pyrotinib: 400mg orally daily
~Drug: Trastuzumab Trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 6 cycles;
~Drug: Docetaxel Docetaxel: 75mg/m2 for a total of 6 cycles
~Drug: Carboplatin Carboplatin: AUC=5 or 6 for a total of 6 cycles"
15874394|NCT03847805|Other|Scapulothoracic and glenohumeral stabilization exercises|The experimental group followed a program that included three scapulothoracic stabilization exercises and three for glenohumeral stability, while subjects in the control group only performed the glenohumeral stabilization exercises. Two weekly sessions were carried out over a period of 6 weeks, and each session lasted 30 minutes. The intervention was conducted before starting the training session, to avoid muscle fatigue. Three series, with 10 repetitions of each exercise, with one minute rest between series.
15874395|NCT03847805|Other|Glenohumeral stability exercises|the control group only performed the glenohumeral stabilization exercises. Two weekly sessions were carried out over a period of 6 weeks, and each session lasted 30 minutes. The intervention was conducted before starting the training session, to avoid muscle fatigue.
15874396|NCT03847792|Drug|Group DB/Dexamethasone-Bupivacaine|The patient were received an intra-articular injection of 18ml bupivacaine 0.25% added to 8mg dexamethasone.
15874397|NCT03847792|Drug|Group FB /Fentanyl-Bupivacaine|The patient were received an intra-articular injection of 1 ug/kg fentanyl added to 18ml of 0.25% bupivacaine.
15874398|NCT03847792|Drug|Group PB/Placebo-Bupivacaine|Patients were received an intra-articular injection of 2ml isotonic saline added to 18ml of 0.25% bupivacaine.
15874399|NCT03847779|Other|"Rest"|Cutaneous perfusion and vasomotion assessment at rest in supoine position
15874400|NCT03847779|Other|"Exercise"|Cutaneous perfusion and vasomotion assessment after the 6minute-wlaking test
15874401|NCT03847779|Other|"Foot lowering"|Cutaneous perfusion and vasomotion assessment after foot lowering
15874402|NCT03847779|Other|"Hyperthermia"|Cutaneous perfusion and vasomotion assessment during hyperthermia
15874403|NCT03847766|Behavioral|PRO-based follow-up|Diagnose specific questionnaires are used to screen patients in need of contact to the outpatient clinic
15874801|NCT03844763|Drug|CTX|CTX: 50 mg Daily untill PD or major toxicity
15874802|NCT03844763|Radiation|RT|RT: 8 Gy single shot day 8
15874406|NCT03847753|Other|Substance Use Disorders|Individuals were considered to have a specific mental disorder from the date they received a relevant diagnosis registered in the Danish Psychiatric Central Research Register.
15874407|NCT03847753|Other|Schizophrenia Disorders|Individuals were considered to have a specific mental disorder from the date they received a relevant diagnosis registered in the Danish Psychiatric Central Research Register.
15874408|NCT03847753|Other|Mood disorders|Individuals were considered to have a specific mental disorder from the date they received a relevant diagnosis registered in the Danish Psychiatric Central Research Register.
15874409|NCT03847753|Other|Neurotic disorders|Individuals were considered to have a specific mental disorder from the date they received a relevant diagnosis registered in the Danish Psychiatric Central Research Register.
15874410|NCT03847753|Other|Eating Disorders|Individuals were considered to have a specific mental disorder from the date they received a relevant diagnosis registered in the Danish Psychiatric Central Research Register.
15874411|NCT03847753|Other|Personality Disorders|Individuals were considered to have a specific mental disorder from the date they received a relevant diagnosis registered in the Danish Psychiatric Central Research Register.
15874412|NCT03847753|Other|Intellectual Disorders|Individuals were considered to have a specific mental disorder from the date they received a relevant diagnosis registered in the Danish Psychiatric Central Research Register.
15874413|NCT03847753|Other|Developmental Disorders|Individuals were considered to have a specific mental disorder from the date they received a relevant diagnosis registered in the Danish Psychiatric Central Research Register.
15874414|NCT03847753|Other|Behavioral Disorders|Individuals were considered to have a specific mental disorder from the date they received a relevant diagnosis registered in the Danish Psychiatric Central Research Register.
15874415|NCT03847740|Device|Isometric Trumb Force handle|Compare the pattern of neuromuscular blocking drug between two devices applied on the same patient during general anesthesia.
15874416|NCT03847727|Drug|BR as Maintenance|Patients of the study group who have achieved at least a partial response after 6 cycles of BR induction will receive additionally 4 cycles of BR every 3 months as maintenance therapy.
15874417|NCT03847714|Dietary Supplement|Omni-Biotic Stress Repair|The probiotic supplement is a commercially available food for special medical purposes and includes 9 bacterial strains with at least 7.5 billion organisms (7.5 × 109 Colony Forming Units/g) per 1 portion (= 3 g).
15874418|NCT03847714|Dietary Supplement|placebo|similar looking and tasting powder
15874421|NCT03847688|Device|Transcranial Magnetic Stimulation|Patient receive Transcranial Magnetic Stimulation for treatment resistant depression as part of their routine care.
15874422|NCT03847675|Behavioral|Reach out and Read|"The intervention group will be viewing a video encouraging to read to their children and giving tips on reading methods, in addition will be given a schematic pamphlet highlighting the importance of reading Arabic to children.
~After each visit participants will receive an age appropriate book for their child (a total of 3 books). The first book consist of popular nursery rhymes that are usually sung for younger infants. The choice of the 2 other books is based on recommendations from an early child educator according to age specificity.
~Focus group conducted by a qualitative researcher will follow the protocol reported by Richard A. Krueger."
15874423|NCT03847649|Drug|Durvalumab|1500 mg IV, 60 min, Day 1 every 4 weeks
15874424|NCT03847649|Drug|Prednisone|0.5mg/kg; PO, Daily cycles 1 & 2
15874425|NCT03847649|Drug|Prednisone|10mg, PO, Daily cycles 1 & 2
15874426|NCT03847636|Device|CryoBalloon ablation|Endoscopic cryoablation (cryogen is contained nitrous) using a CryoBalloon catheter to ablate up to 4 separate DA.
15874427|NCT03847623|Dietary Supplement|Curcumin|Natural compound, active ingredient of turmeric, in bi-daily dosing
15874428|NCT03847623|Other|Placebo|Placebo tablets at bi-daily dosing
15874429|NCT03847610|Drug|Phenoxymethyl Penicillin|Phenoxymethylpenicillin tablets, 500mg every six hours for six doses, starting the day before study
15874430|NCT03847610|Device|Microneedle array|The microneedle biosensor will be sited peripherally (on the non-dominant arm) for the duration of the study. It will then be removed.
15874431|NCT03847597|Procedure|Explantation of the femoro-popliteal arterial segment from the amputed limb|Explantation of the femoro-popliteal arterial segment from the amputed limb
15874432|NCT03847584|Other|Survey|The survey is based on the Theory of Planned Behaviour and assesses intention to participate in NutriQuébec as well as attitude, subjective norm, and perceived behavioural control. The salient beliefs underlying the determinants of individual's intention to participate in the NutriQuébec study most frequently cited in the focus groups (from a preliminary elicitation study: 2018-042 A-1/18-05-2018) were used to develop the survey questions. The survey also assesses the preferences regarding the recruitment. Sociodemographic questions are also asked.
15874433|NCT03847571|Drug|Acetazolamide|Correction of metabolic alkalosis by inhibition of the filtered bicarbonate load reabsorption in the proximal tubules using acetazolamide (AZ)
15874434|NCT03847558|Diagnostic Test|FSH((Follicle Stimulating Hormone) and LH (Luteinizing Hormone) hormone for females and Testosterone hormone for males|assess of sexual maturation by clinical examination and hormonal studies (FSH.LH,Testosterone)
15874435|NCT03847545|Drug|Fampridine|sustained-release tablet 10 mg morning and evening.
15874436|NCT03847532|Genetic|Sanger sequencing method|Amplification of the examined fragments of the MutYH gene was conducted using the PCR machine TP4-PCR-01-Tertsik (DNA-Technology, Russia) containing 25 μL of the reaction mixture: 0.1-1.0 μg genomic DNA; 0.25 μM of each original oligoprimer; 200 μM of each nucleosidetriphosphate; 1 U Taq polymerase; PCR buffer (500 mM Tris, 500 mM KCl, pH 8.74); 2.5 μL MgCl2 (25 mM)); deionized water; 20-30 μL of mineral oil. For MutYH gene analysis (Transcript ENST00000257430) Primer3 software (http:// frodo.wi.mit.edu/primer3/input.htm) was selected and 16 primer pairs. The variants of the primary structure in the obtained fragments were revealed using SSCP. DNA fragments containing electrophoretically identified variants were sequenced.
15874437|NCT03847519|Drug|ADXS-503|A live attenuated Listeria monocytogenes (Lm)-based immunotherapy bioengineered to elicit T cell responses against shared tumor antigens commonly found in patients with squamous and non-squamous NSCLC.
15874438|NCT03847519|Drug|Pembrolizumab|a programmed death receptor-1 (PD-1)- blocking antibody.
15874439|NCT03847506|Drug|Ezetimibe/Rosuvastatin|Ezetimibe/Rosuvastatin 10 mg/10 mg + Candesartan cilexetil/Amlodipine besylate 8 mg/5 mg + Candesartan cilexetil 8 mg placebo
15874440|NCT03847506|Drug|Candesartan cilexetil/Amlodipine besylate|Candesartan cilexetil/Amlodipine besylate 8 mg/5 mg + Ezetimibe/Rosuvastatin 10 mg/10 mg placebo + Candesartan cilexetil 8 mg placebo
15874441|NCT03847506|Drug|Candesartan cilexetil|Ezetimibe/Rosuvastatin 10 mg/10 mg + Candesartan cilexetil 8 mg + Candesartan cilexetil/Amlodipine besylate 8 mg/5 mg placebo
15874442|NCT03847493|Other|Endothelial Glycocalyx|Non-invasive assessment of endothelial glycocalyx dimensions.
15874443|NCT03847480|Radiation|FDG-PET guided dose painting|The radiation dose inside the gross tumor volume is increased according to the voxel intensity (SUV - standardized uptake value) of pre-treatment FDG PET.
15874444|NCT03847467|Drug|2'-Fucosyllactose|Human milk oligosaccharide prebiotic dietary supplement
15874445|NCT03847467|Other|Placebo|Dextrose
15874446|NCT03847454|Combination Product|REACH|The intervention consists of a mobility device called ActivLife developed by Alreh Medical, that is coupled with serious games, a Kinect sensor and a wearable sensor called Stepwatch, to continuously measure the patients physical activity.
15874447|NCT03847454|Other|Standard of care|Standard of care for rehabilitation treatment for musculoskeletal patients.
15874448|NCT03847441|Drug|Calcipotriol|Calcipotriol ointment (0.005%)
15874449|NCT03847441|Device|Narrow Band UVB|NB-UVB (311nm) phototherapy
15874450|NCT03847441|Diagnostic Test|vitamin D3 level|vitamin D3 (ng/ml)
15874454|NCT03847415|Diagnostic Test|ultrasound|to evalute abnormal uterine bleeding in postmenopausal women using 3D(dimensional) ultrasound assessment of endometrial volume .Doppler assessment of endometrium and hysteroscopy and to correlate this finding with pathological finding of endometrial biopsy
15874455|NCT03847402|Behavioral|The early integrated intervention for GDD|The early integrated intervention for GDD integrates developmental approaches with strategies of applied behavior analysis.
15874456|NCT03847402|Behavioral|The early integrated intervention for ASD|The theoretical underpinnings of the early integrated intervention for ASD originate from Early Start Denver Model.
15874457|NCT03847402|Behavioral|The early integrated intervention for ADHD|The methods of the early integrated intervention for ADHD includes behavior training, sensory integration training and psychological counseling
15874458|NCT03847402|Behavioral|community intervention for ASD|TEACCH (Treatment and Education of Autistic and related Communication- handicapped Children) intervention or ABA(applied behavior analysis) intervention
15874459|NCT03847402|Behavioral|Community intervention for GDD|community intervention based on developmental approaches
15874460|NCT03847402|Behavioral|community intervention for ADHD|School and family education
15874461|NCT03847389|Drug|Clobetasol propionate 0.05% Topical Oil|thin film application of the oil twice daily
15874462|NCT03847376|Drug|Rilpivirine Long Acting (RPV LA)|Participants will receive RPV LA injectable suspension containing 300 milligram per milliliter (mg/mL) of RPV by intramuscular (IM) injection. A starting dose of 900 milligram (mg) RPV LA (3 milliliter [mL] suspension) will be administered with subsequent doses of 600 mg RPV given at 4-week intervals.
15874463|NCT03847363|Procedure|epidural anesthesia|epidural anesthesia
15874464|NCT03847363|Procedure|nerve block|paravertebral or serratus anterior plane block
15874465|NCT03847337|Other|Telehealth-Screening Tool for Autism in Toddlers (STAT)|Structured autism screening tool
15874466|NCT03847337|Other|Telehealth-Autism Spectrum Disorder-Pediatrics (ASD-PEDS)|Semi-structured autism screening tool
15874467|NCT03847324|Other|Pain Neuroscience Education|"This program is mainly based in Explain Pain concept, used in multiple rehabilitation programs. Its aim is to change the subject's pain understanding, teaching them the biological processes underneath the pain construct, as a mechanism to reduce itself and its related maladaptive thoughts and behaviors."
15874468|NCT03847324|Other|Multimodal Physiotherapy|This intervention will be divided in pain neuroscience education, orthopedic manual therapy and therapeutic exercise.
15874469|NCT03847324|Other|Usual Care|Usual care will be divided in: preoperative biomedical group-based education, postoperative hospital rehabilitation and home-based postoperative physiotherapy.
15874470|NCT03847311|Drug|Sulfasalazine|This group will receive supplies for 3 months of sulfasalazine at an initial dose of 0.5 gram three times a day for a week then at a dose of 1 gram three times a day for the remainder of the 3 months. Subjects will be asked to take their medications with every meal in addition to their regular pain medications.
15874471|NCT03847311|Drug|Placebos|This group will receive supplies for 3 months of sugar pills three times a day for 3 months. Subjects will be asked to take their medications with every meal in addition to their regular pain medications.
15874472|NCT03847298|Other|Physical activity and physical fitness assessment|Physical fitness was assessed using Munich Physical Fitness Test (MFT). The SenseWear Armband metabolic holter device was used to record the physical activity level for consecutive 7 days. The functional exercise capacity of the individuals was assessed by the six-minute walking test (6MWT) and cardiorespiratory capacity was assessed by maximal exercise test on the treadmill.
15874473|NCT03847285|Other|solid organ transplantation|solid organ transplantation: kidney, heart, pancreas, lung and liver transplantation
15874474|NCT03847272|Drug|prednisone and ustekinumab treatment|Treatment with prednisone and ustekinumab (90 mg subcutaneously at inclusion (W0), W4 and W16)
15874475|NCT03847272|Other|Ophthalmologic examination|Best corrected visual acuity (BCVA) testing, Slit Lamp Exam, tonometry, dilated indirect ophthalmoscopy, optical coherence tomography (OCT), Fluorescein angiography and Indocyanin green angiography
15874476|NCT03847272|Other|Questionnaires|VFQ-25 and SF-36
15874477|NCT03847272|Biological|Blood samples|Additional blood samples for immunomonitoring
15874478|NCT03847259|Diagnostic Test|mechanical posture changes|evaluated by Posture screen mobile, (BackPEI) questionnaire , VISUAL ANALOG SCALE (VAS), Depression Anxiety Stress Scales-21(DASS-21).
15874479|NCT03847246|Drug|Baraclude® tablets,1.0 mg|oral,once,under fasting condition
15874480|NCT03847246|Drug|Entecavir tablets,1.0 mg|oral,once,under fasting condition
15874481|NCT03847233|Device|Jetstream Atherectomy System|A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA
15874482|NCT03847220|Diagnostic Test|BOMET-QoL questionnaire|study to evaluate the utility of the BOMET-QoL questionnaire in patients with BC and BM
15874483|NCT03847207|Drug|HTL0030310|Solution for Subcutaneous injection
15874484|NCT03847207|Drug|Pasireotide|Pasireotide 600 μg for subcutaneous injection
15874485|NCT03847207|Drug|Placebo|Matching placebo Solution
15874490|NCT03847168|Drug|KN026|Patient will be intravenously administrated with one dose of KN026 every week or every other week.
15874491|NCT03847155|Drug|Nicotine patch|The patients will receive a nicotine patch for the period of a maximum of 7 days.
15874492|NCT03847155|Other|Placebo patch|The patients will receive a placebo patch for the period of a maximum of 7 days.
15874493|NCT03847142|Other|ASTHMAXcel mobile application|ASTHMAXcel is a mobile application (patient-facing) that delivers guideline-based asthma education.
15874494|NCT03847142|Other|Outpatient primary care|Usual care delivered through the outpatient primary care setting
15874495|NCT03847129|Other|Biofeedback training|Before the biofeedback training, the baseline pinch force detected from a pinch-holding-up activity is recorded to set the target level according to the baseline data. With the aim for improving the performance, a 94% peak force value detected at the baseline is set as the target threshold for the training. Each participant attends a 30-minute biofeedback protocol per session, two times a week for six to eight weeks. Once the pinch force value exceeds the target range, visual and auditory cues are provided to inform the subjects to modify the performance.
15874496|NCT03847129|Other|Home-based tendon gliding and resistance training|The participants receive similar doses of home-based tendon gliding exercises and resistance training with an anti-stress ball for 30 minutes at a frequency of 2 times a week for 6 to 8 weeks, also combined with the regular diabetic care treatment. Six to eight telephone visits are carried out to remind the patients to comply with the exercise program during the training period.
15874497|NCT03847103|Other|Robotic-assisted Therapy with Bilateral Practice|40-minute robotic-assisted therapy with bilateral practice program for wrist and forearm repetitive movement training was performed during each session.
15874498|NCT03847103|Other|Unilateral Task-specific Training|40 -minute unilateral task-specific training using various tasks: picks up beans with spoon, pouring water from one glass to another glass, opening and closing a drawer, drinking from a mug, and wiping the table were chosen for facilitating multitude of upper extremity functions. Three tasks per session were chosen for various specific components of hand-arm function training.
15874499|NCT03847103|Other|Sensorimotor Stimulation Program|10-minute sensorimotor stimulation program with repetitive range of motion exercises of upper extremity, proprioceptive neuromuscular facilitation and Rood approach
15874500|NCT03847090|Drug|Reloxaliase|Reloxaliase 2 capsules, orally, with each meal/snack, 3 to 5 times per day
15874501|NCT03847090|Drug|Placebo|Placebo 2 capsules, orally, with each meal/snack, 3 to 5 times per day
15874502|NCT03847077|Behavioral|iPad counseling|Women with leiomyomata confirmed on imaging who presented as a new patient to the gynecology clinic at a single institution were randomized to receive multimedia counseling using the drawMD OB/GYN iPad application.
15874503|NCT03847077|Behavioral|Standard Counseling|Women with leiomyomata confirmed on imaging who presented as a new patient to the gynecology clinic at a single institution were randomized to receive standard counseling.
15874504|NCT03847051|Diagnostic Test|MRI|Brain MRI without intravenous contrast
15874505|NCT03847038|Procedure|Preventive strategies advice and dementia risk estimate disclosure|The BBRC-DemPrev-2018 study is a multimodal lifestyle-interventional, longitudinal, and prospective study of participants with a subjective perception of cognitive decline (SCD) or with mild cognitive impairment (MCI). Participants are disclosed their 5-year dementia risk estimate
15874506|NCT03847012|Other|exercise|The test order will be random. After at least 12 times of cardiopulmonary rehabilitation training, the test will be performed again.
15874507|NCT03846986|Dietary Supplement|Apple Juice1|Apple Juice1
15874508|NCT03846986|Dietary Supplement|Apple Juice2|100% Apple Juice with enzyme-treated apple pomace fiber
15874509|NCT03846986|Dietary Supplement|Raw Apple|Raw Apple
15874510|NCT03846973|Drug|Tranexamic Acid|intravenous infusion of 1 g infusion to be given and completed over 8 h in the hospital
15874511|NCT03846973|Other|Placebo|placebo (normal saline) infusion to be given and completed over 8 h in the hospital
15874512|NCT03846960|Device|using specially adapted VNscope|surfactant administration via thin catheter using a specially adapted VNscope
15874513|NCT03846960|Drug|surfactant administration|surfactant administration via thin catheter using a specially adapted VNscope
15874514|NCT03846947|Device|MR Fingerprinting|The MR fingerprinting technique requires less than 15 minutes total and will be added before and after the standard MRI sequence.
15874515|NCT03846934|Device|Ultrasonography thoracic|Thoracic ultrasonography will be performed as soon as possible after admission to the ED, without delaying the start of treatment and in addition to routine thoracic radiography.
15874516|NCT03846921|Diagnostic Test|Laboratory blood test|Laboratory blood test will be analyzed to determine whether there is a rise in alpha-defensin
15874517|NCT03846908|Other|MCT|patients will receive fat load with MCT
15874518|NCT03846908|Other|SFA|patients will receive fat load with SFA
15874519|NCT03846908|Other|MUFA|patients will receive fat load with MUFA
15874520|NCT03846895|Device|Microablative Fractional CO2 laser|3 therapies intravaginally administered will be applied at monthly intervals
15874521|NCT03846869|Diagnostic Test|major cations|blood sample
15874522|NCT03846856|Other|Biopsy|Biopsy taken during surgical procedure
15874523|NCT03846843|Drug|OCR-002 IR Oral Tablet|OCR-002 3 gram immediate release (IR) tablet for oral administration
15874524|NCT03846843|Drug|OCR-002 Oral Solution|OCR-002 5 gram solution for oral administration
15874525|NCT03846843|Drug|OCR-002 IV Solution|OCR-002 5 gram solution for intravenous (IV ) administration
15874526|NCT03846830|Device|Incremental Velocity Error (IVE)|A lightweight headband has electronics attached that detect head velocity and move a laser target at a fraction of the head velocity.
15874527|NCT03846830|Behavioral|Traditional Vestibular Rehabilitation (VPT)|Standard of care, meta-analysis vetted, eye and head motion exercises to reduced morbidity associated with dizziness and imbalance.
15874528|NCT03846817|Other|Physiotherapist-led treatment|12-week of semi-standardized, progressive physiotherapist-led treatment aiming to increase hip muscle strength and load capacity.
15874529|NCT03846804|Diagnostic Test|Karius Test|Next-generation sequencing of blood and synovial fluid samples for pathogen identification in children with musculoskeletal infections
15874530|NCT03846791|Other|Observational Study Post MAKO Robotic Surgery|To assess clinical outcomes and surgery related resource use in the year post surgery for patients undergoing hip replacement surgery using the MAKO robot
15874531|NCT03846765|Drug|Phenylephrine|"Phenylephrine will be administered continuously after intubation in order to maintain blood pressure in a range from MAPbaseline -20% to normal (preoperative) values (MAPbaseline). If MAP decreases to a value lower than MAPbaseline -20%, a higher dose of vasopressor will be administered. If MAP increases to a value above MAPbaseline, the dosing rate will be decreased.
~Phenylephrine will be started at 0,2 μg/kg/min and adjusted according to the patient's hemodynamic status. The dose will be adjusted to MAP during a 30-minute study period."
15874532|NCT03846765|Drug|Dobutamine|"Dobutamine will be administered continuously after intubation in order to maintain blood pressure in a range from MAPbaseline -20% to normal (preoperative) values (MAPbaseline). If MAP decreases to a value lower than MAPbaseline -20%, a higher dose of vasopressor will be administered. If MAP increases to a value above MAPbaseline, the dosing rate will be decreased.
~Dobutamine will be started at 2 μg/kg/min; and adjusted according to the patient's hemodynamic status .The dose will be adjusted to MAP during a 30-minute study period."
15874533|NCT03846752|Procedure|radial artery access for complex PCI|Complex PCI with access via radial artery using a 7 Fr. Glideslender sheath. PCI will be performed according to standard procedures and left to the discretion of the operator, however in case of stent placement the use of Ultimaster stents (Terumo) are highly recommended.
15874534|NCT03846752|Procedure|femoral artery access for complex PCI|Complex PCI with access via femoral artery using a 7 Fr. standard femoral sheath . PCI will be performed according to standard procedures and left to the discretion of the operator, however in case of stent placement the use of Ultimaster stents (Terumo) are highly recommended.
15874535|NCT03846739|Drug|Oxytocin nasal spray|Intranasal administration, 6, 12, or 24 international units (IU) oxytocin.
15874536|NCT03846739|Drug|Placebo|The placebo nasal sprays contain identical ingredients except for the peptide itself.
15874537|NCT03846726|Procedure|standard TME surgery|radical resection for rectal cancer
15874538|NCT03846713|Procedure|non-thermosoftening|By using airway exchange catheter, tube exchange is performed from single to double lumen tube that was put into normal saline at room temperature.
15874539|NCT03846713|Procedure|thermosoftening|By using airway exchange catheter, tube exchange is performed from single to double lumen tube that was put into warm normal saline (40°C).
15874540|NCT03846700|Device|aquablation|"minimally invasive, robot-assisted and ultrasound-guided ablation of the prostate in targeted way and in heat-free way working by high pression water jet"
15874541|NCT03846700|Device|holep|holmium laser enucleation of prostate
15874542|NCT03846700|Device|pvp|photoselectivevaporization of prostate
15874543|NCT03846661|Device|Physiomesh|difference in risk for recurrence and postoperative complication
15874544|NCT03846648|Drug|Cypep-1|"Eligible subjects will be randomized to one of the two treatment groups in a ratio of 1:1 (active:placebo).
~The treatment groups are:
~CyPep-1 topical formulation 1% (w/w)
~Vehicle topical formulation (placebo) The minimum set of studied warts is 1 treated common wart per subject. The subjects will be randomly assigned to treatment. During the treatment period topical formulation will be applied daily on to a maximum of 3 warts. One selected wart will serve as target wart, i.e. the primary wart, for detailed analysis. Selection of warts will be based on the feasibility to conduct treatment application and pharmacodynamics (including biopsy sampling) on the region of interest."
15874545|NCT03846622|Other|Calculation of scoring systems for bleeding|
15874546|NCT03846609|Device|double balloon interventional platform (DiLumen)|double balloon interventional platform (DiLumen) is used for removal of colonic polyp
15874547|NCT03846609|Device|no double balloon interventional platform (DiLumen)|double balloon interventional platform (DiLumen) is not used for removal of colonic polyp
15874548|NCT03846596|Biological|Additional blood tube|Additional blood tube during care
15874549|NCT03846583|Drug|Tucatinib|Tucatinib is a drug that inhibits human epidermal growth factor receptor 2 (HER-2) protein, which is a protein expressed in the cancer cells. By inhibiting this protein, tucatinib may help stop or reduce the growth of the tumor
15874550|NCT03846583|Drug|Abemaciclib|Abemaciclib is a cyclin-dependent kinase (CDK) inhibitor. CDK inhibitors work to stop cell growth.
15874551|NCT03846583|Drug|Trastuzumab|"• Trastuzumab is called a targeted therapy because it works by attaching itself to specific receptors on the surface of breast cancer cells, known as HER2 receptors. When Trastuzumab attaches to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the immune system."
15874803|NCT03844750|Procedure|Hepatectomy|Undergo liver resection.
15874552|NCT03846583|Drug|Aromatase Inhibitor|These drugs act by lowering the amount of estrogen produced by the body by blocking an enzyme called aromatase
15874553|NCT03846570|Drug|Formoterol-beclomethasone|formoterol (fumarate dihydrate) 12 microg - beclomethasone (dipropionate) 200 microg administered BID, per inhalation using '100/6' Metered Dose Inhaler
15874554|NCT03846570|Drug|Placebo|Matching placebo (identically package) administered BID
15874555|NCT03846557|Device|Transcatheter Aortic Valve Implantation (TAVI)|Implantation of the Acurate Neo Transcatheter Heart Valve
15874556|NCT03846544|Drug|CFA-double pick up|In the study group, 225 IU of rFSH will continue after the first oocyte retrieval (OR). Antagonist administration will be initiated when at least one follicle measuring ≥14 mm will be present in the ultrasound. If one or more follicles ≥17 mm are observed, patients will undergo a second triggering with hCG 5000 IU and a second OR will be performed. In case of patients with no follicular development following 10 additional days of rFSH post-OR
15874557|NCT03846531|Device|Nano-Pulse Stimulation (NPS)|The Pulse generator delivers electrical pulses (nanosecond duration) that are applied directly to targeted lesion using sterile treatment tips with micro-needles.
15874558|NCT03846518|Device|Hyrax|Rapid maxillary expansion using the Hyrax expander. Appliance anchorage will be performed by bands adapted to the first maxillary molars and arms of the screw contoured to adapt to palatal faces of the first and second maxillary bicuspids, in wich will be bonded by resin. The screw will be positioned perpendicularly to the palate sagittal midline, between second maxillary bicuspids and first maxillary molars, and 5 mm apically from marginal gingiva of palatal face of the first maxillary molars.The activation protocol will be 2 turns a day up to obtain transverse overcorrection. After the active period of RME, the screws will be fixed with ligature wire and the appliance will be kept as a retainer for 6 months.
15874559|NCT03846518|Device|mini Hyrax|Rapid maxillary expansion using the mini Hyrax expander. Appliance anchorage will be performed by bands adapted to the first maxillary molars and arms of the screw contoured to adapt to palatal faces of the first and second maxillary bicuspids, in wich will be bonded by resin. The screw will be positioned perpendicularly to the palate sagittal midline, between second maxillary bicuspids and first maxillary molars, and 5 mm apically from marginal gingiva of palatal face of the first maxillary molars. The activation protocol will be 2 turns a day up to obtain transverse overcorrection. After the active period of RME, the screws will be fixed with ligature wire and the appliance will be kept as a retainer for 6 months.
15874560|NCT03846505|Drug|Oxytocin|A 40-IU dose of oxytocin will be self-administered 30 minutes prior to the start of each weekly ABCT session.
15874561|NCT03846505|Other|Placebo|A placebo will be self-administered 30 minutes prior to the start of each weekly ABCT session.
15874562|NCT03846492|Device|Transcranial Direct Current Stimulation (tDCS)|tDCS is a non-invasive brain stimulation modality that does not require general anesthesia or surgical implantation of a device. tDCS utilizes low intensity electrical current either to increase cortical excitability with an anodal electrode or to suppress cortical excitability with a cathodal electrode. It uses 3 AAA batteries to deliver direct current via rubber electrodes enclosed in saline soaked sponges.
15874563|NCT03846479|Drug|Itacitinib|for up to 56 days
15874564|NCT03846466|Drug|KHK4323 IV/S|IV / Single administration
15874565|NCT03846466|Drug|KHK4323 SC/S|SC / Single administration
15874566|NCT03846466|Drug|KHK4323 IV/M|IV / Multiple administration
15874567|NCT03846466|Drug|Placebo IV/S|IV / Single administration
15874568|NCT03846466|Drug|Placebo IV/M|IV / Multiple administration
15874569|NCT03846466|Drug|Placebo SC/S|SC / Single administration
15874570|NCT03846453|Biological|0.25% HL036 Ophthalmic Solution|0.25% HL036 Ophthalmic Solution consists of all components of the drug product solution with 0.25% Active Pharmaceutical Ingredient (API)
15874571|NCT03846453|Biological|Placebo|The placebo solution consists of all components of the drug product solution with the exception of API
15874572|NCT03846440|Other|No intervention|Cross-sectional
15874573|NCT03846427|Drug|Zanubrutinib|Zanubrutinib at a dose of 160 mg PO Twice a Day (BID)
15874574|NCT03846414|Drug|PEG-rhG-CSF|PEG-rhG-CSF was administered 24 hours after the end of chemotherapy for each chemotherapy cycle.
15874575|NCT03846401|Device|fiberoptic bronchoscopy|"Will be performed according to British Thoracic Society guidelines 2013.
~-Microbiological methods The specimen (tracheal aspirate & BAL) will be collected under aseptic conditions in a sterile container and immediately sent to the laboratory for microbiological analyses.
~Samples will be apply for:
~Direct smear by Gram stain and ZeihlNelseen stain
~Samples culturedinBact/alert bottle(BioMérieux, France).
~Isolation of causative organism from positive cases by:
~Subculture on MacConkey , blood , chocolate agar , Sabouroud's agar and Lowenstien Jensen media.
~Identification of isolated organism and drug sensitivity test by Automated Vitek2 Compact(BioMérieux, France).
~Multiplex PCR for detection of Respiratory viruses in lower respiratory tract"
15874576|NCT03846388|Diagnostic Test|follicular stimulating hormone|in the serum of our patients
15874577|NCT03846388|Diagnostic Test|Anti-mullerian hormone|in the serum of our patients
15874578|NCT03846388|Radiation|Basal antral follicle count|by ultrasound
15874579|NCT03846375|Behavioral|Psychotherapy|DBT is a well-established treatment for recurrent self-harm and suicidal thoughts. The program is principle-based, but the skills training follow a manualized curriculum.
15874580|NCT03846375|Other|Pre-intervention testing|Pre-intervention testing for baseline measures.
15874581|NCT03846362|Other|HSCT|allogenic HSCT from 5-8 HLA-MM family donor as a first choice for patients with initial high risk of relapse and for patients with MRD2>0,1% and initial intermediate risk
15874582|NCT03846349|Device|IOPI|IOPI is a portable device with a tongue bulb used to reinforce upper airway muscles.
15874583|NCT03846349|Device|EMT threshold|EMT threshold is a small portable device producing a positive expiratory pressure when the patient is exhaling.
15874584|NCT03846336|Other|Upper extremity function|Upper extremity function was evaluated with 9-Hole Peg Test (9-HPT). The 9-HPT is a brief, standardized, quantitative test of upper extremity function. It consists of moving nine pegs into one of the nine holes on a peg board, then back into an open box. Both the dominant and non-dominant hands are tested twice.
15874642|NCT03845959|Drug|TD0019 oral capsule|TD0019 are green, hard capsule with size 0, containing yellow herbal powder with special smell of herbal.
15874643|NCT03845959|Drug|Placebo oral capsule|Placebo
15874585|NCT03846336|Other|Shoulder position sense|Shoulder position sense was evaluated with a Dualer IQTM digital inclinometer (J-TECH medical, Salt Lake City, UT, USA). The absolute error scores (in degrees) for shoulder abduction and flexion at 30° and 60° was calculated. The upper extremity of the participant was positioned with the arm in the scapular plane for the abduction movement and in the sagittal plane for the flexion movement. After returning to the starting position, participants attempted to repeat the previously attained angle. Participants indicated verbally when they felt they had reached the angle and held their position. The measurement was repeated 2 more times for a total of 3 trials for each limb (non-dominant and dominant), with a 30-second rest period separating trials.
15874586|NCT03846323|Other|Visiting policies: 24 hours a day, 7 days a week|
15874587|NCT03846323|Other|Restriction of visiting policies < 6 hours|
15874588|NCT03846310|Drug|Etrumadenant|Etrumadenant is an A2aR and A2bR antagonist
15874589|NCT03846310|Drug|Zimberelimab|Zimberelimab is a fully human anti-PD-1 monoclonal antibody
15874590|NCT03846310|Drug|Carboplatin|Carboplatin administered as part of standard chemotherapy regimen
15874591|NCT03846310|Drug|Pemetrexed|Pemetrexed administered as part of standard chemotherapy regimen
15874592|NCT03846310|Drug|Pembrolizumab|Pembrolizumab is a humanized anti-PD-1 monoclonal antibody
15874593|NCT03846284|Drug|Bupivacaine|caudal block with bupivacaine 0.25% 1mg/kg diluted in 10 cm saline.
15874594|NCT03846284|Drug|Magnesium sulfate 50mg|caudal block with bupivacaine 0.25% 1mg/kg plus Magnesium sulfate 50 mg diluted in 10 cm saline.
15874595|NCT03846284|Drug|Magnesium sulfate 30 mg|"caudal block with bupivacaine 0.25% 1mg/kg diluted in 10 cm saline.
~+ I.V injection of Magnesium sulfate 30mg/kg diluted in 10 cm saline over 10 mins then, fol I.V infusion one ampule of Magnesium sulfate 500mg diluted in 50 cm saline with rate 10 mg/kg/h."
15874596|NCT03846271|Drug|intranasal oxytocin|24 IU of oxytocin nasal spray will be applied to each subject.
15874597|NCT03846271|Drug|intranasal placebo|an identical amount of placebo nasal spray will be applied to each subject.
15874598|NCT03846258|Drug|Low bicarbonate solution (22 mmol/L)|Participants randomized to this arm will be started on CRRT using Phoxillum as the replacement fluid.
15874599|NCT03846258|Drug|High Bicarbonate solution (32 mmol/L)|Participants randomized to this arm will be started on CRRT using Prismasate as the replacement fluid.
15874600|NCT03846245|Other|No intervention|No intervention
15874601|NCT03846232|Other|No intervention|No intervention
15874602|NCT03846219|Drug|IMU-838 (30 mg/day)|"Main treatment period: All patients will receive half the assigned dose during the first 7 days of the main treatment period (1 tablet per day) and then start taking the full assigned dose from Day 7 onwards (2 tablets once daily).
~Extended treatment period (optional): patients will receive 30 mg/day IMU-838 for up to 9.5 years. Patients on active treatment during the main treatment period will be randomized to continue their previous treatment assignment. Identical to the start of the main treatment period, all patients will receive half the assigned dose during the first 7 days of the extended treatment period and will then continue with the full assigned dose.
~Once the results of the main treatment period are available, investigators and patients currently in the extended treatment period will be unblinded and investigators may then recommend switching the dose to a more effective dose or to an equally effective dose but with a lower risk for adverse events."
15874603|NCT03846219|Drug|IMU-838 (45 mg/day)|"Main treatment period: All patients will receive half the assigned dose during the first 7 days of the main treatment period (1 tablet per day) and then start taking the full assigned dose from Day 7 onwards (2 tablets once daily).
~Extended treatment period (optional): patients will receive 45 mg/day IMU-838 for up to 9.5 years. Patients on active treatment during the main treatment period will be randomized to continue their previous treatment assignment. Identical to the start of the main treatment period, all patients will receive half the assigned dose during the first 7 days of the extended treatment period and will then continue with the full assigned dose.
~Once the results of the main treatment period are available, investigators and patients currently in the extended treatment period will be unblinded and investigators may then recommend switching the dose to a more effective dose or to an equally effective dose but with a lower risk for adverse events."
15874604|NCT03846219|Drug|Placebo|"Main treatment period: All patients will receive 1 tablet per day during the first 7 days of the main treatment period and then start taking 2 tablets once daily from Day 7 onwards.
~Extended treatment period (optional): Patients receiving placebo during the main treatment period will be randomized to 30 or 45 mg/day IMU-838. Identical to the start of the main treatment period, all patients will receive half the assigned dose during the first 7 days of the extended treatment period and will then continue with the full assigned dose.
~Once the results of the main treatment period are available, investigators and patients currently in the extended treatment period will be unblinded and investigators may then recommend switching the dose to a more effective dose or to an equally effective dose but with a lower risk for adverse events."
15874605|NCT03846206|Dietary Supplement|mediterranean diet|a Mediterranean diet supplemented with 50 g / day of olive oil and 15g / day of nuts for three months
15874606|NCT03846193|Biological|GT005|A recombinant non-replicating adeno-associated viral (AAV) vector encoding a human complement factor
15874607|NCT03846193|Biological|GT005|A recombinant non-replicating adeno-associated viral (AAV) vector encoding a human complement factor
15874608|NCT03846193|Biological|GT005|A recombinant non-replicating adeno-associated viral (AAV) vector encoding a human complement factor
15874609|NCT03846193|Biological|GT005|A recombinant non-replicating adeno-associated viral (AAV) vector encoding a human complement factor
15874610|NCT03846193|Device|GT005|A recombinant non-replicating adeno-associated viral (AAV) vector encoding a human complement factor
15874611|NCT03846193|Device|GT005|A recombinant non-replicating adeno-associated viral (AAV) vector encoding a human complement factor
15874612|NCT03846193|Device|GT005|A recombinant non-replicating adeno-associated viral (AAV) vector encoding a human complement factor
15874613|NCT03846180|Drug|Terlipressin|Continuous or intermittent intravenous infusion of terlipressin was given.
15874614|NCT03846180|Drug|Somatostatin|Continuous or intermittent intravenous infusion of somatostatin was given.
15874615|NCT03846180|Drug|Octreotide|Continuous or intermittent intravenous infusion of octreotide was given.
15874644|NCT03845946|Behavioral|angioedema|electronic tracking book
15874804|NCT03844750|Biological|Pembrolizumab|Given IV
15874616|NCT03846167|Drug|Imaging Drug FluorThanatrace (FTT)|[18F]FTT is an investigational radioactive PET drug used to see PARP-1 activity in tumors. This radioactive imaging drug is injected into the body to see how it goes into places where there is active breast cancer. Using an imaging scan called Positron Emission Tomography (PET/CT), the radioactive drug can be seen in the body.
15874617|NCT03846154|Behavioral|Comprehensive family intervention including individual sessions of FORNET|"A group intervention once a week for about 20 weeks, including psychoeducation on mental health and drug abuse, anger management, roles within families, developing plans for the future, communication skills, sex education.
~Access to schools and school material
~Family visits
~Their parents received training regarding agriculture and microcredit projects, and financial assistance
~FORNET if affected by trauma-related symptoms, and/or acting aggressive
~If needed medical assistance /.) If needed, legal assistance"
15874618|NCT03846141|Other|Placebo|Inhalation of room air for 20 min per day during 7 days
15874619|NCT03846141|Other|Hydrogen|Inhalation of 4% hydrogen for 20 min per day during 7 days
15874620|NCT03846128|Biological|blood sample|blood sample performed on C1D1, C1D14, C2D1, C3D1 and C6D1
15874621|NCT03846115|Behavioral|Peer-Led Seeking Safety app|This app offers participants sessions of Seeking Safety plus enhanced app features designed to engage and sustain participants in their recovery work.
15874622|NCT03846115|Behavioral|Control app|This app offers the Seeking Safety content but without the enhanced features
15874623|NCT03846102|Drug|Levobupivacaine|Levobupivacaïne for injection 7.5 mg/kg diluted with Sodium Chloride 0,9%
15874624|NCT03846102|Drug|Placebo|Sodium Chloride 0,9% for injection/infusion.
15874625|NCT03846102|Drug|Acetaminophen|Acetaminophen 500 milligram tablet
15874626|NCT03846102|Drug|Morphine|Morphine 1 mg/ml solution for infusion.
15874627|NCT03846102|Procedure|Fascia Iliaca Compartment Block with Levobupivacaine|Ultrasound guided Fascia Iliaca Compartment Block with levobupivacaine placed in the emergency department by an emergency physician.
15874628|NCT03846102|Procedure|Fascia Iliaca Compartment Block with placebo|Ultrasound guided Fascia Iliaca Compartment Block with placebo placed in the emergency department by an emergency physician.
15874629|NCT03846089|Procedure|Graft reperfusion|antegrade (forward) or retrograde (backward) blood reperfusion of the liver graft
15874630|NCT03846076|Behavioral|Cognitive behavioral therapy|Cognitive behavioral therapy
15874631|NCT03846063|Other|Home-based rehabilitation program|The duration of the program is 12 weeks. Patients start the program within 7 days after of the surgery. Patients perform exercises independently at home using the tablet PC for instructions. The program includes strengthening and walking exercises based on increasing the muscle force, balance, and functionality. The exercises comprise movements that train abductors, flexors, and extensors of the affected hip. The content of the program is based on previous research and on guidelines from the American Association of Orthopaedic Surgeons. For the rest, the program is designed in line with the most recent guidelines from the Royal Dutch Society for Physical Therapy. Patients are asked to exercise at least 5 days a week, with rest days on Thursday and Sunday. Strengthening exercises will be performed 3 times a week. The instructions for the exercises will be provided by videos on the tablet PC, which patients have to imitate.
15874632|NCT03846050|Behavioral|BAC feedback/warning|Participants will receive a warning when their BAC reaches a set limit. The cutpoint for this warning is not disclosed but is well below the legal limit for driving. Warning will notify them that their results indicate it is not safe for them to drive.
15874633|NCT03846050|Behavioral|No BAC feedback/warning|Participants will receive no information on their current intoxication and will be asked to report less information on their driving decisions.
15874634|NCT03846037|Other|Proprioceptive exercise on the vibratory platform|Unipodal support over the non-dominant lower limb with the contralateral limb in a knee flexion near 90ºon the vibratory platform
15874635|NCT03846037|Other|Proprioceptive exercise on the ground (stable surface)|Unipodal support over the non-dominant lower limb with the contralateral limb in a knee flexion near 90ºon the ground
15874636|NCT03846024|Device|RibFx Orthosis Belt|Each patient in the interventional arm will be fitted with a RibFx orthosis belt, which is to be worn during the majority of their day (excluding showering/bathing). It will be encouraged (though not mandatory) to wear at night. Patients in both the control and interventional arm will be expected to participate in pulmonary hygiene / toilet exercises with guided and independent incentive spirometry as per our normal routine and standard of care. There are no other interventions or procedures that the patients will be subjected to for the research trial- other procedures/interventions will be performed only if the clinical care team feels they are indicated.
15874637|NCT03846011|Other|24-h urine collection|Collecting 24-h urine prior and after stone removal surgery
15874638|NCT03845998|Procedure|use the three-finger method|The size of the laryngeal mask airway was determined by choosing the laryngeal mask that best matched the combined widths of the patient's index, middle and ring fingers.
15874639|NCT03845998|Procedure|use the weight-related method|The size of the laryngeal mask airway was determined by the patient's weight.
15874640|NCT03845985|Behavioral|Seeking Safety + Signs of Safety toolkit|"Seeking Safety is an existing, present-focused, first-stage manualized treatment for trauma and addiction. Session content engages clients in themes relevant to addiction and trauma, and to help them learn a specific skill to target symptoms of both AUD and PTSD (e.g., Coping with Triggers, Asking for Help).
~Signs of Safety is a culturally and linguistically Deaf-accessible toolkit to be used alongside Seeking Safety. The toolkit includes a therapist guide and population-specific client materials (e.g., visual handouts; ASL teaching stories on digital video). It is designed for Deaf/signing clinicians, as well as non-signing clinicians working with ASL interpreters."
15874641|NCT03845972|Procedure|SSFTB|Patients who underwent major knee surgery and had already planned to perform subsartorial femoral triangle block (SSFTB) were included in the study. They were measured the outcomes the night before surgery. The saphenous nerve and nerve to vastus medialis were blocked at the subsartorial femoral triangle level by experienced anesthesiologists. After standard monitor, the distal femoral triangle was identified 2 cm proximal to the opening of adductor canal by ultrasound guidance. At this level, The location of nerve to vastus medialis was confirmed by nerve stimulator and it was blocked with 0.5% levobupivacaine 5 ml. Then, 0.5% levobupivacaine 10 ml would be injected perifemoral artery. The outcomes were re-assessed 30 min after block.
15874805|NCT03844750|Drug|Vactosertib|Given orally, twice per day (PO BID)
15874645|NCT03845933|Procedure|Colon polypectomy|Polyp search and resection will be performed during the withdrawal phase in both groups. Insertion polypectomy will not be performed. All proximal colon polyps will be removed irrespective of their size and appearance.
15874646|NCT03845920|Combination Product|tdcs (sham/anodal) + drug (placebo/tyrosine)|"tDCS= A DC Stimulator Plus (neuroConn, Germany) with one 5 cm x 7 cm rubber electrode (anode) and a 10 cm x 10 cm (cathode; reference electrode), encased in saline soaked sponges will be used. The anode will be positioned over the left dlPFC, centered on F3 in the 10e20 electroencephalography (EEG) system, while the cathode on the contralateral supraorbital ridge (Fp2).Current will be delivered at 1.5mA for 20 min plus 30 s fade in/fade out periods.For sham stimulation, the current will be faded in over 30 s, at 1.5mA and then will be switched off.
~Drugs= 2.0 g of L-Tyrosine and 2.0 g of the placebo microcrystalline cellulose will be dissolved in 400ml of orange juice as per previously published protocols."
15874647|NCT03845907|Device|Gen 1B|Diagnostic Ultrasound and Optoacoustic Imaging
15874648|NCT03845907|Device|Gen 1|Diagnostic Ultrasound and Optoacoustic Imaging
15874649|NCT03845894|Drug|Liposomal bupivacaine|Interscalene brachial plexus blockade using liposomal bupivacaine (expanded with plain bupivacaine)
15874650|NCT03845894|Drug|Bupivacaine with adjuvants|Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone.
15874651|NCT03845881|Drug|Oxycodone|The primary endpoint will be pain scores, calculated by the Visual Analog Scale. This score will be collected daily during the hospital examination and by phone surveys for two weeks following discharge. Investigators hypothesize that the non-opioid pain regimen will provide equivalent relief as compared to the opioid regimen.
15874652|NCT03845881|Drug|Placebo Oral Tablet|The primary endpoint will be pain scores, calculated by the Visual Analog Scale. This score will be collected daily during the hospital examination and by phone surveys for two weeks following discharge. Investigators hypothesize that the non-opioid pain regimen will provide equivalent relief as compared to the opioid regimen.
15874653|NCT03845868|Other|Dietary and environmental exposure (Observational study)|
15874654|NCT03845855|Other|virtual reality|Virtual reality with a game
15874655|NCT03845855|Other|robotic gait|robotic gait therapy
15874656|NCT03845842|Behavioral|Volitional help sheet|Participants are asked to choose from a list of strategies for avoiding cannabis use.
15874657|NCT03845829|Procedure|In situ laser assisted fenestration|In situ laser assisted fenestration for the left subclavian artery during the procedure of TEVAR for type B aortic dissection
15874658|NCT03845816|Behavioral|Self-Compassion Scale (SCS) questionnaire|all included patients with chronic pain will answer the Self-Compassion Scale (SCS) questionnaire
15874659|NCT03845803|Other|Reducing sedentary behaviour|Implementing sit/stand workstations at work
15874660|NCT03845790|Other|Blood and microdialysis samples|Blood and microdialisys pharmacocinetic samples on one of the two antibiotics prescribed in routine use
15874661|NCT03845777|Diagnostic Test|Using Antiseptic solution|Using of iodine including antiseptic solutions. The investigators investigate the urine iodine status of staff before and after the using of antiseptic solution
15874662|NCT03845764|Diagnostic Test|Rapid on-site evaluation|Specimens obtained with endoscopic sampling procedures are stained with a rapid method (i.e., Diff Qui) and submitted to on-site cytologic review
15874663|NCT03845751|Drug|HIFU hemi-ablation combined with ADT.|Hemi-ablation of the cancer-harbouring prostatic lobe will be carried out using HIFU energy. Short-term 3-month ADT will be administered concomitantly.- Short-term ADT is administered as a single subcutaneous injection of 3-month depot of 22.5 mg of leuprolide acetate (luteinizing hormone-releasing hormone [LHRH] agonist). Additionally, oral antiandrogen bicalutamide 50 mg once per day is given for two weeks, starting one week before the LHRH agonist injection. The ADT protocol starts within 1 month prior to the scheduled HIFU session
15874664|NCT03845738|Device|OsseoSpeed EV implant|The investigational product (OsseoSpeed EV implant) is already included in a restoration in the subject at enrollment, thus this study does not involve the installation of any investigational products.
15874665|NCT03845712|Drug|MT1621|deoxythymidine/deoxythymidine substrate enhancement therapy
15874666|NCT03845699|Device|Diagnostic algorithms that detects/predicts hypoventilation|Produce mild and moderate respiratory depression (hypoventilation) using a controlled intravenous infusion of fentanyl while measuring/recording respiratory rate, tidal volume, body activity, and body position.
15874667|NCT03845686|Diagnostic Test|Perfusion functional Magnetic Resonance Imaging (perfusion fMRI)|The goal of this test is to measure brain activity during subacute and chronic post-stroke period using a widely available non-invasive neuroimaging tool - functional Magnetic Resonance Imaging (fMRI). Because fMRI relies in part on cerebral blood flow, which is altered in stroke, measuring longitudinal changes in neural activity with fMRI requires that we control for concomitant changes in blood circulation. To do this, we will employ a novel dual-echo perfusion fMRI sequence, which will allow us to separately estimate neural and vascular contributions to fMRI.
15874668|NCT03845673|Dietary Supplement|Psyllium|Psyllium fiber (Konsyl; Konsyl Pharmaceuticals, Easton, Md)
15874669|NCT03845673|Dietary Supplement|Bowel recipe|consisted of 1 cup of unprocessed wheat bran, 1 cup of applesauce, and 1/4 cup of prune juice.
15874670|NCT03845660|Behavioral|Electronic Alert|"Patients randomized to the intervention will have an alert of their prognosis based on the best available prognostic models for inpatient and 1-year mortality generated with information from their electronic health record, which will consist of a pop-up when the provider accesses a patient record to enter a progress note after the definitions for inclusions into the study have been registered."
15874671|NCT03845647|Procedure|contralateral central lymph node dissection|contralateral central lymph node dissection
15874672|NCT03845621|Device|Conventional Mouthguard|Use of a conventional custom-made mouthguard while playing water polo
15874673|NCT03845621|Device|Occlusal-adjusted Mouthguard|Use of an occlusal-adjusted custom-made mouthguard while playing water polo
15874674|NCT03845608|Combination Product|Pulmonary Recruitment Maneuver|Pulmonary recruitment maneuver will be performed manually using positive-pressure ventilation to inflate the lungs and lower the diaphragm, which can increase intraperitoneal pressure mechanically and remove residual carbon dioxide from the peritoneal cavity.recieve100 mg hydrocortisone in 250 ml normal saline at end of surgery and carbon dioxide will be removed by applying gentle abdominal pressure and removing carbon dioxide by passive exsufflation
15874675|NCT03845595|Device|(LF-rTMS) group|"The (LF-rTMS) (low frequency repetitive transcranial magnetic stimulation) group received 1-hertz (HZ) stimulation at 90% of motor threshold to the hot spot of the primary cerebral cortex, using a 70-mm figure- 8 coil and Magstim Rapid2 stimulator (Magstim Company, USA). Contralesional 1 HZ *rTMS* applied over the primary motor area hot spot at 90% of Active motor threshold . Each rTMS session consisted of 1,200pulses; lasting 20 minutes The optimal site of stimulation on the skull are known as the hot spot . Hot spots were found by searching for loci that triggered maximum visible contraction in the contralateral first dorsal interosseous *FDI* muscle, while the patient is contracting his whole limb as much as possible ."
15874676|NCT03845595|Other|Control group|neurodevelopmental technique (NDT) ( including Bobath and Brunnstrom approaches , proprioceptor and exteroceptor stimulation for the weak and inhibition for the hyperactive muscle groups, proprioceptive neuromuscular facilitation (PNF) specific techniques, Approximation and weight bearing, placing technique). Task-oriented training (moving, grasping and releasing bottles ,cups , small toys). Active participation of the whole hemiparetic upper extremity in different motor task training with coordination and Bilateral arm training exercise.
15874677|NCT03845582|Drug|ALK-001 oral capsule|Daily administration for 24 months
15874678|NCT03845582|Drug|Placebo oral capsule|Daily administration for 24 months
15874679|NCT03845569|Other|Dietary protein intake reduction|Following two days of controlled diet at 2.2g/kg/d of dietary protein, intake was reduced to 1.2g/kg/d for five days, and protein metabolism was measured on days 1, 3, and 5.
15874680|NCT03845569|Other|Three day Controlled Diet|Three days of a controlled diet providing 2.2g/kg/d of dietary protein with protein metabolism measured on day 3. This was used to model the habitual intake of this cohort.
15874681|NCT03845543|Device|Luminor-14 Paclitaxel eluting balloon|Patients will be treated with the Luminor-14 paclitaxel eluting balloon
15874682|NCT03845530|Diagnostic Test|Blood Test|Blood test taken and sent for laboratory analysis
15874683|NCT03845517|Drug|Placebo|Placebo
15874684|NCT03845517|Drug|PF-06700841 15 mg|PF-06700841 15 mg
15874685|NCT03845517|Drug|PF-06700841 30 mg|PF-06700841 30 mg
15874686|NCT03845517|Drug|PF-06700841 45 mg|PF-06700841 45 mg
15874687|NCT03845504|Device|Intermittent Theta Burst Stimulation|Daily open-label sessions delivered to left DLPFC over up to 6 weeks using the MagVenture MagPro rTMS Research System at currently FDA approved parameters (www.magvitatms.com). The TBS parameters will be 3-pulse 50-Hz bursts given every 200 ms (at 5 Hz) and an intensity of 80% active motor threshold, as measured from the right first dorsal interosseous muscle by a hand-held 700-mm figure-of-eight coil. rTMS will be applied for 9 min delivering a total of 1800 pulses/session.
15874688|NCT03845491|Device|Mechanical Thrombectomy|Treatment of LVO with mechanical thrombectomy
15874689|NCT03845478|Behavioral|Control Group (CG)|The control group is subjected to follow a hypocaloric diet and receives information about the benefits of achieving 10,000 steps a day in weight loss and improved body composition.
15874690|NCT03845478|Behavioral|Intervention Group (IG)|This group in addition to fulfilling a hypocaloric diet identical to the control group, and receive identical information about physical activity that the control group, it has a system of prescription, monitoring and establishing an objective to achieve 10,000 steps a day.
15874691|NCT03845465|Behavioral|Positive Affect + Education|Adolescents will complete a health behavior contract and receive an educational packet at baseline. Adolescents will complete a positive affect interview at baseline. They will receive automated text messages 5 days/week for 8 weeks. Messages will be tailored to include adolescents' responses to the baseline interview, including reminders to engage in gratitude and self-affirmation. Additionally, to induce positive mood they will be texted gift cards codes valued at $5.00. Further, caregivers will be asked to provide weekly positive affirmations to their adolescents, focused on non-diabetes strengths.
15874692|NCT03845465|Behavioral|Education|Adolescents will complete a health behavior contract and receive an educational packet with information about diabetes management.
15874693|NCT03845439|Other|Lumbar puncture|Lumbar puncture
15874694|NCT03845426|Other|Root canal treatment.|Once pulpal necrosis has been diagnosed, root canal treatment will be carried out by the patient's general practitioner. This is an end point for the tooth in the study.
15874695|NCT03845413|Behavioral|Control|Schedule an appointment to attend tobacco cessation at Basic Health Unit
15874696|NCT03845413|Behavioral|12-home visits by the Community Health Worker + referring to an appointment for the participant to attend the tobacco cessation program|12-home visits by the Community Health Worker + referring to an appointment for the participant to attend the tobacco cessation program
15874697|NCT03845387|Drug|KDT-3594|oral administration, dose titration
15874698|NCT03845387|Drug|Pramipexole|ER formulation, oral administration, dose titration
15874699|NCT03845374|Device|Hyper-CL™ lens|Use of the Hyper-CL™
15874700|NCT03845361|Procedure|Radial artery cannulation|Radial artery cannulation
15874701|NCT03845348|Other|TD03|Shampoo TD 3 days
15874702|NCT03845348|Other|TD07|Shampoo TD 7 days
15874703|NCT03845348|Drug|Ketoconazole 2% Shampoo|Ketoconazole 2% Shampoo
15874704|NCT03845335|Device|dental implant-supported restoration|During the oral surgery session for dental implant insertion, after implant site preparation, the opaque sealed envelope containing the patient allocation will be opened. Following the group allocation, the patient will receive either an HA-coated Hybrid or moderately rough dental implant
15874705|NCT03845322|Drug|Curcumin Pill|Curcumin (turmeric extract), over the counter supplement (1 capsule/three times a day). According to the Company, each capsule contains: 270 mg of pure curcuminoids (curcumin) and 3 mg of black pepper extract. Recommended serving size is 3 capsules per day in total, the patients will receive 810 mg of pure curcumin and 9 mg of black pepper extract (peperine/BioPerine) per day.
15874706|NCT03845322|Drug|Placebo pills|The placebo pill is a vegetarian cellulose capsule, with cellulose powder inside. The composition is cellulose and magnesium stearate.
15874707|NCT03845309|Behavioral|Self-Care Behavior|Limitations on liquid and sodium intake will be established in accordance with the NYHA functional classification, and patients will be provided with dietary assessments and nutrition advice according to personal characteristics such as age, physical activity level, and comorbidities. Additionally, suggestions on lifestyle changes were provided by referring to the advice for patients with heart failure from the American Heart Association.
15874708|NCT03845296|Drug|Rucaparib|Given PO
15874709|NCT03845283|Behavioral|Online Behavioral Weight Loss Program|A self-guided, online program that helps participants reduce excess calories and gradually increase physical activity.
15874710|NCT03845283|Behavioral|Physical Activity Intervention|An program designed to help participants gradually increase their physical activity and maintain an active lifestyle. The program encourages bouts of moderate-to-vigorous physical activity. Participants in this group will receive a Fitbit Versa to help them monitor their physical activity that they will be advised to wear daily. Participants will receive brief (5-10 minute) lessons weekly for the first 3 months and monthly for the last 3 months.
15874711|NCT03845283|Behavioral|Bite Counter|Participants will receive a Bite Counter device to help them monitor and reduce their within-meal consumption. Participants will be asked to wear the device daily.
15874712|NCT03845283|Behavioral|Virtual Reality|This program allows participants to practice behavioral weight loss skills using a virtual reality system compatible with their home device. This program helps patients practice these skills in the following artificial settings: at home, at work, at the gym, and at a party. Each participant will be asked to play through each scene at least once during their participation, though they are encouraged to use the program regularly.
15874713|NCT03845283|Behavioral|Virtual Meetings|Participants will attend virtual meetings using their own device. Each virtual meeting focuses on a specific topic that will help patients lose weight. Participants are asked to virtually attend at least 6 meetings during their participation. There is no limit to how many they can attend. The meeting topics will rotate and repeat on a schedule.
15874714|NCT03845270|Drug|pertuzumab + trastuzumab + docetaxel|Cycle 1 : D1 : pertuzumab 840 mg, D2 : trastuzumab 8 mg/kg + docetaxel 75 mg/m² Subsequent cycle : D1 : pertuzumab 420 mg + trastuzumab 6 mg/kg + docetaxel 75 mg/m²
15874715|NCT03845257|Diagnostic Test|Blood sampling, FeNO, bronchoalveolar lavage, bronchoscopic tissue sampling|Blood sampling (eosinophil count; eosinophilia is defined as >300/µl (or >150/µl during oral glucocorticosteroid treatment); FeNO: Measurement of fractional nitric oxide (NO) concentration in exhaled breath; Bronchoscopy: BAL: total leukocyte counts and leukocyte differential counts including eosinophils, PSB sampling: eosinophil count/100 cells, endobrochial biopsy: tissue eosinophil count/100 cells.
15874716|NCT03845244|Device|Flow reduction first|-10L/min q 1hr
15874717|NCT03845244|Device|FiO2 reduction first|- 0.1 q 1hr
15874718|NCT03845244|Device|Simultaneous (flow and FiO2) reduction|-10L/min and -0.1 q 1hr
15874719|NCT03845231|Biological|Flucelvax(R)|Cohort 1 will receive IM quadrivalent IIV (Flucelvax (R)) at the standard dose of 15 micrograms HA per strain (60 micrograms HA total).
15874720|NCT03845231|Other|Human Challenge virus|A dose of 10^7 50% tissue culture infective dose (TCID50) of human challenge virus will be administered intranasally to all participants using a nasal sprayer.
15874721|NCT03845205|Behavioral|Integrated AUD Treatment|IAT will include computer-delivered BI in the hospital, nurse-delivered alcohol monitoring counseling at each outpatient LT follow-up visit, and at-home participation in web-based, 7-session CBT4CBT, supplemented by tailored text messages.
15874722|NCT03845192|Device|ORI measurement by Radical 97|"ORI measurement is done from the beginning of the induction of anaesthesia until the end of the induction of anaesthesia or until the end of the stay in the operating theatre. The measurement to ORI is done by the Radical-97 device by Masimo®."
15874723|NCT03845179|Other|Placebo|Saline infusion
15874724|NCT03845179|Other|GIP receptor antagonist|Used for infusion on study days
15874725|NCT03845179|Drug|DPP-4 inhibitor|Oral administration of DPP-4 inhibitor in active treatment period
15874726|NCT03845179|Other|Placebo tablet|Oral administration of placebo tablet in placebo treatment period
15874727|NCT03845166|Drug|XL092|oral doses of XL092
15874728|NCT03845166|Drug|Atezolizumab|Supplied as 1200 mg/20 mL vials; administered as a 1200 mg IV infusion once every 3 weeks (q3w)
15874729|NCT03845166|Drug|Avelumab|Supplied as 200 mg/10 mL vials; administered as an 800 mg IV infusion once every 2 weeks (q2w)
15874730|NCT03845153|Drug|Metformin Retard 850 mg|tablet
15874731|NCT03845153|Other|Placebo|placebo tablet
15874735|NCT03845127|Device|Revivent TC Ventricular Enhancement System|Anchors that are implanted into the left ventricle to reshape and reduce the size and increase the efficiency of the pumping chamber.
15874736|NCT03845127|Drug|GDMT|Guideline Directed Medical Therapy
15874737|NCT03845114|Other|Continous exercise|60-minute continuous exercise on the ergocycle at 60% of VO2 peak (moderate intensity).
15874738|NCT03845114|Other|Interval exercise|Participants will perform a 60-minute interval exercise on the ergocycle at 60% of VO2 peak (moderate intensity).
15874739|NCT03845114|Other|Reduction of basal insulin by 40%|Participant's insulin basal rate will be reduced by 40% 1 hour before exercise onset.
15874740|NCT03845114|Other|Reduction of basal insulin by 80%|Participant's insulin basal rate will be reduced by 80% 1 hour before exercise onset.
15874741|NCT03845101|Behavioral|CBT with virtual reality exposure therapy|The patients receiving the in virtuo exposure will be immersed using an Oculus Go head-mounted display, enabling viewing of 360° spherically camera recorded VR environments. The VR scenarios will thus be high-resolution 360° stereoscopic films, that are played around the viewer. For ease of use, the individual videos will be administered from an app that has been designed to be as intuitive to operate as possible. The patient will only have to put on the headset, adjust the focus and choose the desired environment by looking at it in the app. 360° video was chosen because it gives the most photorealistic visuals, while also being the cheapest to produce. The downside is that it does not allow direct user-interaction (e.g. the viewer cannot affect the environment in any way). To circumvent this, there are multiple junctions throughout the films where the actors will talk directly and unsolicited to the viewer while also allowing time for the viewer to respond.
15874792|NCT03844789|Device|t:slim X2 with Control-IQ Technology & Dexcom G6 CGM|Eligible participants will be use the t:slim X2 with Control-IQ Technology & Dexcom G6 CGM technology for 16 weeks during the main study. All participants will be provided the option of continue using the t:slim X2 with Control-IQ system in a 12 week Extension Phase. This arm to be uset:slim X2 with Control-IQ Technology & Dexcom G6 CGM
15874742|NCT03845101|Behavioral|CBT in vivo|"The therapeutic intervention is manual-based cognitive-behavioral CBT group therapy adapted from the approach of Turk, Heimberg & Magee and Graske & Barlow with worksheets from Arendt & Rosenberg and inspiration from Bouchard et al. The treatment will consist of 14 weekly two-hour group sessions following the manual to ensure equal and uniform treatment for every patient throughout the study. Concurrent psychopharmacological treatment is allowed in both intervention arms.
~Turk CL, Heimberg RG, Magee L. Social anxiety disorder. In: Barlow DH, editor. Clin Handb Psychol Disord A step-by-step Treat Man.
~Graske MG, Barlow DH. Panic Disorder and Agoraphobia. In: Barlow DH, editor. Clin Handb Psychol Disord. 4th ed.
~Rosenberg NK, Mørck MM, Arendt M. Kognitiv terapi. Nyeste udvikling. Kogn Ter Nyeste Udvikl. 2012.
~Bouchard S, Robillard G, Larouche S, Loranger C. Description of a treatment manual for in virtuo exposure with specific phobia."
15874743|NCT03845088|Procedure|temporomandibular jont reconstruction with costochondral transplantation|temporomandibular jont reconstruction with costochondral transplantation guided by virtual mandibular position
15874744|NCT03845075|Drug|Tesofensine|During Part 1 subjects will be randomized to treatment with co-administration of 0.5 mg tesofensine/50mg metoprolol (active medication)
15874745|NCT03845075|Drug|Placebo|During Part 1 subjects will be randomized to matching placebo treatment with co-administration of 0.5 mg tesofensine/50mg metoprolol
15874746|NCT03845049|Other|Inclusion examinations|Pregnancy test, Visual acuity, ocular pressure, color retinophotography, OCT-SD (the Heidelberg SDOCT Spectralis, or the Cirrus HD-OCT, model 5000, Zeiss), OCT-angiography and fluorescein angiography and wide-field angiogram
15874747|NCT03845049|Drug|Aflibercept Injection [Eylea]|Intravitreal injection of aflibercept at inclusion, M1, M2, M3 and M4. An additional injection may be planned for M5, on the decision of the clinician and on clinical arguments only.
15874748|NCT03845049|Drug|SHAM injection|Intravitreal injection of SHAM at inclusion, M1, M2, M3 and M4. An additional injection may be planned for M5, on the decision of the clinician and on clinical arguments only.
15874749|NCT03845049|Other|Examinations during study (every month)|visual acuity, ocular pressure, OCT-SD, OCT-angiography and ocular fundus and a pregnancy test at M6
15874750|NCT03845036|Behavioral|DASH Diet plus Home-Based Exercise|The DASH dietary program consists of a diet emphasizing foods rich in fruits, vegetables, whole grains, and low-fat dairy, in which patients record daily servings of fruits and vegetables. The home-based exercise program consists of intermittent walking to moderate claudication pain 3 times per week for 3 months in a home-based setting.
15874751|NCT03845036|Behavioral|Home-Based Exercise|The home-based exercise program consists of intermittent walking to moderate claudication pain 3 times per week for 3 months in a home-based setting.
15874752|NCT03845023|Drug|AD036 Dose 1|AD036 Dose 1 oral capsule administered before sleep
15874753|NCT03845023|Drug|AD036 Dose 2|AD036 Dose 2 oral capsule administered before sleep
15874754|NCT03845023|Drug|AD036 Dose 3|AD036 Dose 3 oral capsule administered before sleep
15874755|NCT03845023|Drug|Placebo|Placebo oral capsule administered before sleep
15874756|NCT03845010|Drug|Sotalol|Patients will be titrated to the maximal tolerated dose of sotalol with a targeted dose of 80 thrice daily (TID)
15874757|NCT03845010|Drug|Flecainide and verapamil|Patients will receive maximal tolerated dose of flecainide and verapamil with titration to a maximal dose of 200 mg of flecainide and 240 mg of verapamil per day
15874758|NCT03845010|Procedure|Catheter ablation|Patients will undergo VPB/VT ablation using a percutaneous transfemoral approach according to standard clinical routine
15874759|NCT03844997|Drug|Palcociclib|"Palbociclib is an investigational (experimental) drug that works to induce early G1 arrest by inhibiting CDK4/6, which are two types of CDKs that are overexpressed in AML cell cancer lines. Palbociclib is experimental because it is not approved by the Food and Drug Administration (FDA).
~Palbociclib will be supplied as capsules or tablets containing 125 mg equivalents of Palbociclib free base"
15874760|NCT03844997|Drug|CPX-351|CPX-351 (daunorubicin and cytarabine) liposome for injection is a combination of daunorubicin and cytarabine in a 1:5 molar ratio encapsulated in liposomes for intravenous administration. CPX-351 is an investigational (experimental) drug that works as formulation of a fixed combination of the antineoplastic drugs cytarabine and daunorubicin. CPX-351 is experimental because it is not approved by the Food and Drug Administration (FDA).
15874761|NCT03844984|Drug|ketamine full dose|This group will receive induction of anesthesia using Ketamine 1 mg/Kg.
15874762|NCT03844984|Drug|Midazolam|This group will receive midazolam 0.05 mg/Kg
15874763|NCT03844984|Drug|Normal saline|This group will receive normal saline 10 mL
15874764|NCT03844984|Drug|ketamine half dose|This group will receive induction of anesthesia using Ketamine 0.5 mg/Kg.
15874765|NCT03844984|Drug|Lidocaine|This group will receive lidocaince 1 mg/Kg diluted in 10 mL normal saline.
15874766|NCT03844971|Procedure|Computer assisted arthrocentesis of|Under general anesthesia : patients specific preoperative prefabricated surgical guide will be used intraoperative for arthrocentesis of temporomandibular joint for patients with anterior disc displacement with reduction
15874767|NCT03844958|Other|Red Furu|"50 g red furu was consumed with 2 slices of plain bread for one-day
~50 g Fresh tofu was consumed with 2 slices of plain bread for one-day"
15874768|NCT03844958|Other|Tofu|"50 g Fresh tofu was consumed with 2 slices of plain bread for one-day
~50 g red furu was consumed with 2 slices of plain bread for one-day"
15874769|NCT03844945|Drug|Netarsudil Ophthalmic Solution 0.01%|Topical sterile ophthalmic solution
15874770|NCT03844945|Drug|Netarsudil Ophthalmic Solution 0.02%|Topical sterile ophthalmic solution
15874771|NCT03844945|Drug|Netarsudil Ophthalmic Solution 0.04%|Topical sterile ophthalmic solution
15874772|NCT03844945|Other|Netarsudil Ophthalmic Solution Placebo|Topical sterile ophthalmic solution
15874773|NCT03844932|Drug|ST-0529|ST-0529 utilizes SmPill® technology to encapsulate the otherwise insoluble cyclosporine in a presolubilized, lipid-based formulation.
15874793|NCT03844789|Device|Control Group|Eligible participants will be use the study Dexcom G6 CGM for 16 weeks during the main study. All participants will be provided the option of using the t:slim X2 with Control-IQ system in a 12 week Extension Phase.
15874794|NCT03844776|Drug|Co-Amoxiclav|amoxicillin + clavulanic acid orally
15874795|NCT03844776|Drug|Paracetamol|paracetamol orally
15874796|NCT03844776|Drug|Chlorhexidine mouthwash|0.2% chlorhexidine mouthwash
15874797|NCT03844776|Drug|Normal saline|0.9% normal saline irrigation
15874774|NCT03844919|Device|rTMS + CBIT|"Repetitive Transcranial Magnetic Stimulation (rTMS) parameters are: intensity 100% resting motor threshold (RMT), frequency 1Hz, duration = 30 minutes (1800 stimulations; 900 per side), target - the supplementary motor area (SMA). Treatments occur on weekdays (T - F) for four weeks (20 total).
~The Comprehensive Behavioral Intervention for Tics (CBIT) will be completed over eight sessions that will average 60 minutes in duration. First, participants will undergo awareness training. Participants will then be introduced to competing response training, which involves performing a voluntary behaviour designed to disrupt the execution of the tic. The eight sessions will occur on Mondays, once a week for six weeks and then on weeks 8 and 10."
15874775|NCT03844919|Behavioral|Sham rTMS + CBIT|Sham rTMS (sham coil) will be paired with CBIT. Sham rTMS will be delivered over the same time-frame as above. CBIT will be identical to the above.
15874776|NCT03844906|Drug|SAGE-718|SAGE-718 in combination with Ketamine
15874777|NCT03844906|Drug|Placebo|Placebo in combination with Ketamine
15874778|NCT03844893|Procedure|Mini bal|Mini-BAL is a minimally invasive technique frequently used in the investigator's local intensive care units (ICUs) to obtain alveolar fluid samples from mechanically ventilated patients. This is typically done for microbial analysis.
15874779|NCT03844880|Behavioral|Emotional Awareness and Expression Therapy|Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.
15874780|NCT03844880|Behavioral|Cognitive Behavior Therapy|Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
15874781|NCT03844867|Dietary Supplement|Filippo Cea and Carmel|"Subjects will be given a subjective organoleptic assessment of both the almonds (Filippo Cea and Carmel) administered blindly and randomly.
~Motility test: Each subject will be subjected to gastrointestinal motility study according to international guidelines, i.e. he will be evaluated in 3 different days. The test will be made in response to test-meal ('NutriDrink') or Filippo Cea almonds (12 gr. fat=24 gr. almonds) or Carmel almonds (12 gr. fat = 24 gr. almonds)."
15874782|NCT03844854|Other|Stabilization occlusal splint and manual therapy|Providing stabilization occlusal splint and manual therapy
15874783|NCT03844841|Drug|Propofol|At minimum 5 minutes before start of sedation for atrial fibrillation ablation a bolus of fentanyl (20-50 µg) will be administered. Thereafter, sedation is induced via the continuous infusion of propofol using a target-controlled infusion (TCI) pump. The effect-site propofol concentration will be initially set to 1.5 µg/ml, unless the patient is already sedated by fentanyl. Subsequently, an effect-site propofol concentration of 1 µg/ml will be chosen adjusted stepwise (using steps of 0.3 µg/ml) to reach a target score of 2-3 on the MOAA/S scale. In case of pain fentanyl can be administered bolus-wise (10-30 µg) at the cardiologists discretion.
15874784|NCT03844841|Drug|Dexmedetomidine|At minimum 5 minutes before start of sedation for atrial fibrillation ablation a bolus of fentanyl (20-50 µg) will be administered. Thereafter, sedation is induced with a loading dose of dexmedetomidine (0.8 µg/kg) over 10 minutes. The maintenance dexmedetomidine dose is adjusted to the appropriate sedation criteria for CA (0.4 µg/kg/h) and for a target score of 2-3 on the MOAA/S scale. In case of pain, additional fentanyl can be administered bolus-wise (10-30 µg) at the cardiologists discretion.
15874785|NCT03844828|Device|IOL implantation experimental|Mono- or bilateral implantation of trifocal toric intraocular lenses POD FT. If both eyes of the same patient qualify for the implantation of a trifocal toric lens, a bilateral implantation will be performed. If only one eye qualifies for a trifocal toric lens, the contralateral eye will be implanted with the spherical trifocal IOL POD F (both lenses: (PhysIOL, Liège, Belgium).
15874786|NCT03844815|Drug|Decitabine|"Decitabine will be administered intravenously at a dose of 20mg per day for 10 days during Cycle 1 (28 day cycle)
~Decitabine will be administered intravenously at a dose of 20mg per day for 10 days of Cycle 2 (28 day cycle).
~Decitabine will be administered intravenously at a dose of 20mg per day for 5 days of each 28 day maintenance cycle"
15874787|NCT03844815|Drug|Venetoclax|Venetoclax administered orally on days 1-21 of cycle 1, cycle 2 and maintenance (28 day cycles). Dose levels will be assigned at time of enrollment anywhere from 100mg-400mg. Dose escalation will follow the 3+3 study design.
15874788|NCT03844802|Other|Local Dry needling and exercise|"Deep dry needling will be applied bilaterally in the locus of active or latent myofascial trigger points of several neck shoulder muscles (scalene muscles, levator scapulae, splenius cervicis, multifidus cervicis and upper trapezius). The presence of active or latent myofascial trigger points will be assessed according to the diagnostic procedures described by Travell and Simons. The dry needling intervention technique will be the fast in-fast out Hong technique, with a minimum of 3 to 6 local twitch responses to be elicited.
~Patients will perform a home based therapeutic neck exercises program."
15874789|NCT03844802|Other|Distal Dry needling and exercise|"Patients in this group will undergo deep dry needling at a remote spot from the locus of the myofascial trigger point. As a result no local twitch response should be elicited. As in the previous group, dry needling will be carried out in the same assessed muscles (scalene muscles, levator scapulae, splenius cervicis, multifidus cervicis and upper trapezius) with active or latent myofascial trigger points, according to the diagnostic procedures described by Travell and Simons. The intervention technique chosen for these participants will be to insert the needle in a location in the same muscle, but far away (at least 1 to 1.5 cm) from the location of the myofascial trigger point. Likewise, the needle will be inserted without the intention to evoke local twitch responses. Therefore, the entry and exit of the needle will be performed in a slower fashion.
~Patients will perform a home based therapeutic neck exercises program."
15874790|NCT03844802|Other|Sham dry needling and exercise|"Patients in this group will undergo sham-placebo dry needling. For that purpose, placebo dry needling will be carried out in the same muscles previously described (scalene muscles, levator scapulae, splenius cervicis, multifidus cervicis and upper trapezius) with active or latent myofascial trigger points. The intervention technique will be carried out in the locus of the trigger point but using placebo needles. For this placebo group, a simulation needle procedure using a Dong Bang placebo needle, similar to the Streitberger needle, will be used. The placebo needles evoke mechanical stimulation without piercing the skin; hence, patients experience a pressure sensation similar to that of a real needle.
~Patients will perform a home based therapeutic neck exercises program."
15874791|NCT03844802|Other|Exercise|Patients will perform a home based therapeutic neck exercises program.
15874798|NCT03844776|Drug|Amoxicillin 500 Mg|Amoxicillin 500 orally
15874799|NCT03844776|Drug|Metronidazole|metronidazole 500 mg orally
15874806|NCT03844737|Device|VisuXL®|Treatment of discomfort forms of the ocular surface, in professional water-polo athletes exposed to pool water for prolonged periods.
15874807|NCT03844724|Device|ZENFlow™ Drug-eluting PTA Balloon Dilatation Catheter|Digital subtraction angiography（DSA）
15874808|NCT03844724|Device|Peripheral Balloon Dilatation Catheter|Digital subtraction angiography（DSA）
15874809|NCT03844711|Other|Transcutaneous electrical diaphragmatic stimulation (TEDS)|"Stage I: In the first day (group 1) the parameters will be with 30 Hz frequency and the second day (group 2) will be with 80 Hz, with one-day interval between interventions. The TEDS will be applied with symmetrical biphasic pulsed current, pulse width 0.4 ms, rise time of 1 second (s), 1s lift, 2 s descent, maintaining respiratory rate of 15 rpm, intensity required to obtain visible muscle contraction, for 20 minutes or until muscle fatigue.
~Stage II and III:The TEDS will be applied with symmetrical biphasic pulsed current, the parameters will be with 30 Hz frequency, pulse width 0.4 ms, rise time of 1 second (s), 1s lift, 2 s descent, maintaining respiratory rate of 15 rpm, intensity required to obtain visible muscle contraction, for 20 minutes or until muscle fatigue."
15874810|NCT03844711|Other|Inspiratory Muscle Training (IMT)|- Stage II and III: The training will start with a minimum load of 50% and will be progressed until reaching 60% of the PImax. Inspiratory muscle training will start with a minimum load of 50% and progress to 60% of the MIP. The patients will perform daily training, being two sets of 30 breaths, one in the morning and one in the afternoon.
15874811|NCT03844711|Other|Conventional physiotherapy|- Stage III: It consists of ventilatory exercises, bronchial hygiene techniques, passive, active-assisted or active exercises for upper and lower limbs, and resistance exercises.
15874812|NCT03844685|Drug|Promensil|1 tablet (80 mg) /day of MCE-11 (Promensil) taken orally for 24 months
15874813|NCT03844685|Drug|Placebo Oral Tablet|Placebo tablet (80 mg) (without active principle) given once a day for 24 months
15874814|NCT03844672|Behavioral|Low Power|Participants will receive a low power e-cigarette to use for 3 weeks
15874815|NCT03844672|Behavioral|High Power|Participants will receive a high power e-cigarette to use for 3 weeks
15874816|NCT03844672|Behavioral|Low Concentration|Participants will receive a low concentration e-liquid to use for 3 weeks
15874817|NCT03844672|Behavioral|High Concentration|Participants will receive a high concentration e-liquid to use for 3 weeks
15874820|NCT03844646|Device|CGM|Intermittent use of a continuous glucose monitor (CGM)
15874821|NCT03844646|Other|Dietitian|Monthly meetings with a dietitian
15874822|NCT03844633|Drug|Depo-Provera Injectable Product|Depo-Provera Injectable Product -- Shot administered within 48 hours of childbirth
15874823|NCT03844633|Drug|Placebos|Placebos -- Shot administered within 48 hours of childbirth
15874824|NCT03844620|Other|Best Practice|Receive SOC
15874825|NCT03844620|Other|Laboratory Procedure|Undergo ctDNA testing
15874826|NCT03844620|Other|Quality-of-Life Assessment|Ancillary studies
15874827|NCT03844620|Other|Questionnaire Administration|Ancillary studies
15874828|NCT03844620|Drug|Regorafenib|Given by mouth
15874829|NCT03844620|Drug|Trifluridine and Tipiracil Hydrochloride|Given by mouth
15874830|NCT03844607|Device|Active Transcranial Direct Current Stimulation (tDCS)|Cognitive training concurrent with 2 mAmps of anodal stimulation applied to the left frontal cortex for 20 minutes.
15874831|NCT03844607|Device|Sham Transcranial Direct Current Stimulation (tDCS)|Cognitive training concurrent with sham tDCS (30 secs ramp up/ramp down of current at beginning of session).
15874832|NCT03844594|Drug|Eptifibatide Injection|Recommendation: first, intravenously or intraductal injection of 135ug / kg (completed in 5 minutes), followed by continuous intravenous infusion of 0.75ug / kg / min for 24 hours.
15874833|NCT03844581|Device|interferential current|Treatment was applied using four vacuum electrodes with wet sponge, two of them were put under the patient lumber region on a distance from lumber spinous process by five cm on each side and the other two were applied over the suprapubic region parallel to iliac crest.
15874834|NCT03844581|Drug|Propiverine Hydrochloride|propiverine hydrochloride 20 mg/once per day in the morning
15874835|NCT03844568|Device|nocturnal nasal continuous positive airway pressure|applying nasal continuous positive airway pressure at 7.5-10cmH2O for at least 4 hours during nighttime
15874836|NCT03844555|Drug|Elafibranor|120mg oral single dose
15874837|NCT03844542|Device|Therapeutic plasma exchange|Perform therapeutic plasma exchange in patients with sepsis induced multi-organ failure
15874838|NCT03844529|Device|Sunmax FULLSGEN with Lidocaine|Subject who voluntarily sign the informed consent form (day -14~1) will be randomly assigned to investigational or control group and have intradermal allergy test. After the injection treatment by randomly choosing the device, every subject would have 6 follow-up visits.
15874839|NCT03844516|Other|Peak oxygen uptake test with pacing|Peak oxygen uptake test with paced heart rate
15874840|NCT03844516|Other|Peak oxygen uptake test without pacing|Peak oxygen uptake test without paced heart rate
15874841|NCT03844503|Dietary Supplement|Cereal Bar no fiber|Cereal Bar no fiber
15874842|NCT03844503|Dietary Supplement|Cereal bar with 10 g fiber|Cereal bar with 10 g fiber
15874843|NCT03844503|Dietary Supplement|Cereal bar with 20 g fiber|Cereal bar with 20 g fiber
15874844|NCT03844490|Other|CESSATION OF CORD PULSE|"In this group the umbilical cord will remain unclamped until the spontanous pulsation stops.
~At this time, cord clamping will be made."
15874845|NCT03844490|Other|CONTROL|In this group management will be carried out as usual routine (cord clamping from one to three minutes after delivey)
15874846|NCT03844477|Procedure|single-injection QLB(quadratus lumborum block)|"Inject 0.4ml/kg 0.5% ropivacaine between quadratus lumborum and psoas major without continuous local infusion
~Device: Ultrasound Scanner The curved (C1-5) probe of Ultrasound Scanner is used for scan
~Device: PAJUNK StimuLong Drug: single dose ropivacaine 0.4ml/kg 0.5% ropivacaine given immediately after the correct position of the tip of the needle has been verified."
15875378|NCT03840330|Other|Experimental: High-intensity interval training group|16 weeks of High-intensity interval training
15874847|NCT03844477|Procedure|Placebo control|"Inject 0.4ml/kg saline between quadratus lumborum and psoas major without continuous local infusion
~Device: Ultrasound Scanner The curved (C1-5) probe of Ultrasound Scanner is used for scan
~Device: PAJUNK StimuLong Drug: single dose 0.4ml/kg 0.9% NS. given immediately after the correct position of the tip of the needle has been verified."
15874848|NCT03844451|Drug|Liposomal Bupivacaine|At the conclusion of the procedure, liposomal bupivacaine will be administered as a V2 nerve block.
15874849|NCT03844451|Drug|Bupivacaine and Epinephrine|At the start of the procedure, 0.5% bupivacaine and 1:200,000 epinephrine as a surgical field block.
15874850|NCT03844438|Drug|LPM3480226|The starting dose was 50 mg and the subsequent dose was increased according to the protocol of 100 mg, 200 mg, 400 mg, 600mg.
15874851|NCT03844425|Device|Conventional VFR|Conventional retainers
15874852|NCT03844425|Device|VFR from SLA|SLA has better finishing compared to FDM but it is more expensive.
15874853|NCT03844425|Device|VFR from FDM|FDM has poorer finishing compared to SLA but it is cheaper.
15874854|NCT03844412|Drug|5% lidocaine/5 mg/ml 0.02% estradiol compound cream|Lidocaine/estradiol cream targets peripheral nerves and tissues affected in VBD. Participants will be provided with a diagram and written instructions, detailing how to apply the cream to the vaginal vestibule daily for weeks 1-16. Treatment with lidocaine/estradiol or placebo cream will be terminated at week 16 (end of month 4).
15874855|NCT03844412|Drug|Nortriptyline|Nortriptyline is a centrally-acting tricyclic antidepressant that is FDA-approved for treatment of neuropathic pain. Dosing will begin with one 10 mg pill nightly for week 1, then two 10 mg pills nightly for week 2, three 10 mg pills nightly for week 3, four 10 mg pills nightly for week 4, and five for weeks 5 -16. Treatment with nortriptyline or placebo pill will be tapered off over weeks 16-18, decreasing the dose by 10 mg every 4 days. Participants will be provided with a list of drugs to avoid that are known to interact with nortriptyline.
15874856|NCT03844412|Drug|Placebo cream|The comparison treatment will be an identical-appearing placebo Moisturel™ cream
15874857|NCT03844412|Drug|Placebo pill|The comparison treatment will be an identical-appearing placebo pill
15874858|NCT03844399|Device|Ablation|The medical device will passively record image data during the standard care ablation
15874859|NCT03844399|Device|Biopsy|The medical device will passively record image data during the standard care biopsy
15874860|NCT03844386|Biological|MVA.tHIVconsv3|viral-vector, MVA, expressing immunogens derived from conserved yet immunogenic regions of HIV-1
15874861|NCT03844386|Biological|MVA.tHIVconsv4|viral-vector, MVA, expressing immunogens derived from conserved yet immunogenic regions of HIV-1
15874862|NCT03844386|Other|Placebo|The appropriate amount of Sodium Chloride for Injection USP, 0.9% will be drawn into a syringe.
15874863|NCT03844373|Dietary Supplement|STOCKHOLM|STOCKHOLM is a Food for Special Medical Purposes (FSMP) and must, therefore, be used under medical supervision.
15874864|NCT03844360|Drug|Bortezomib|bortezomib was administered follow the doctor's advice.
15874865|NCT03844360|Drug|Eltrombopag|eltrombopag was administered follow the doctor's advice.
15874866|NCT03844360|Drug|Imatinib|imatinib was administered follow the doctor's advice.
15874867|NCT03844360|Drug|dasatinib|dasatinib was administered follow the doctor's advice.
15874868|NCT03844360|Drug|Pegaspargase|pegaspargase was administered follow the doctor's advice.
15874869|NCT03844360|Drug|Anti-Infective Drugs|anti-infective drugs was administered follow the doctor's advice.
15874870|NCT03844360|Drug|PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor|pegaspargase was administered follow the doctor's advice.
15874871|NCT03844347|Behavioral|Stress management sessions|Stress management sessions are proposed to the patients and consist of small exercises focused on breathing and bodily sensations. Each accompanying person has access to different exercises. The sessions are adapted to the state of the patient to promote his well-being, before or after his/her operation. The duration of a preoperative session is 1 hour, the duration of the postoperative sessions is 15 minutes.
15874872|NCT03844334|Device|WEB Aneurysm Embolization System|Subjects aged ≥ 18 years, but ≤ 80 years requiring treatment for single ruptured or unruptured intracranial aneurysms.
15874873|NCT03844321|Behavioral|Mindfulness-Based Cognitive Therapy|8 sessions of online mindfulness-based cognitive therapy
15874874|NCT03844321|Behavioral|Brief Mindfulness|3 sessions of online mindfulness therapy
15874875|NCT03844308|Behavioral|Isha Kriya Meditation|Isha Kriya (IK) meditation is a meditation that can be learned quickly and requires approximately 12 minutes, twice a day practice. This regimen was chosen because it excels in simplicity and is a great way to introduce meditation to beginners. It does not incorporate a spiritual or religious focus. It was developed by the Isha Institute of Inner Sciences, a nonprofit foundation located at McMinnville, Tennessee.
15874876|NCT03844295|Device|Activated Inspire® Upper Airway Stimulation System|At first, INSPIRE® device will be active a month
15874877|NCT03844295|Device|Inactivated Inspire® Upper Airway Stimulation System|"After 15 days wash-out INSPIRE® device will be inactivated for a second period of one month."
15874878|NCT03844282|Diagnostic Test|Clinical assessment (SCAT5)|The SCAT5 is a standardized tool for evaluating sports-related concussions designed for use by physicians and licensed healthcare professionals in patients aged 13 years and above. It is a ten minute paper-based assessment which includes immediate and office/off-field assessments. SCAT5 incorporates the Maddocks' questions, Glasgow Coma Scale (GCS), cervical spine assessment and symptom evaluation, in addition to cognitive and neurological screening.
15874879|NCT03844282|Diagnostic Test|ImPACT|ImPACT (Immediate Post-Concussion Assessment and Cognitive Testing) is a neurocognitive assessment administered online or using desktop software in a controlled environment. ImPACT has two components: baseline testing and post-injury testing, both of which are used to determine if a patient can safely return to sporting activity post-concussion.
15874931|NCT03843957|Other|"low touch Implementation Strategy"|"Clinics randomized to receive the low touch implementation strategy will receive:
~Pre-Implementation Activities
~• N/A
~Implementation Kick-Off (Day 1)
~• On-site training with key clinic personnel
~Months 1 - 6
~Phone/email technical support, as needed.
~Access to web-based QA dashboard
~Months 7 - 12
~Phone/email technical support, as needed
~Access to web-based QA dashboard"
15874932|NCT03843944|Drug|Safinamide|Overnight switch from rasagiline 1 mg OD to safinamide 50 mg OD
15875379|NCT03840330|Other|Experimental: Moderate-intensity interval training group|16 weeks of Moderate-intensity interval training
15874880|NCT03844282|Behavioral|CANTAB|"Originally developed at the University of Cambridge, the Cambridge Neuropsychological Test Automated Battery (CANTAB) platform includes highly sensitive, precise and objective measures of cognitive function, correlated to neural networks. These tests have demonstrated sensitivity to detecting changes in neuropsychological performance and include tests of working memory, learning and executive function; visual, verbal and episodic memory; attention, information processing and reaction time; social and emotion recognition, decision making and response control.
~The CANTAB touchscreen battery (www.camcog.com) will be utilised to perform neuropsychological assessments within RESCUE-RACER, whose study-specific protocol may include assessments of: Spatial Working Memory (working memory and strategy), Reaction Time (processing and psychomotor speed), Paired Associated Learning and the Multi-Tasking Test."
15874881|NCT03844282|Diagnostic Test|I-PAS/Dx100|I-PAS™ (now re-named Dx 100) is a portable, head-mounted, neural functional assessment tool. With its integrated clinical eye tracking and digital display, the FDA has cleared (K171884) fourteen tests and an unmatched list of variables for clinical use for a variety of conditions. This utility of this device will be investigated for motorsport-related concussion.
15874882|NCT03844282|Biological|Saliva sample|Micro RNA's (miRNA's) are easily measured in saliva and have proven to have both diagnostic and prognostic use in sports-related concussion across the adolescent and adult populations, with levels persisting for some weeks after the concussive event. RESCUE-RACER will collect saliva samples for analysis of biomarkers of concussion, which may include miRNA and other markers of injury.
15874883|NCT03844282|Other|fMRI|RESCUE-RACER participants will be invited to complete a functional MRI scan, whose 90-minute protocol may include: multi-parametric mapping (MPM), susceptibility weighted imaging (SWI), diffusion weighted imaging (DWI), proton spectroscopy and functional MRI (fMRI) with blood oxygenation-level dependent contrast (BOLD), completed at 7T (Tesla), or 3T if this is not possible.
15874884|NCT03844269|Device|AKL-T01|"AKL-T01 digital treatment is a state-of-the-art mobile video game-like platform, which deploys modern videogame graphics, engaging reward loops, and real-time adaptive mechanics to dynamically personalize difficulty based on the user's ability. AKL-T01 multitasking treatment employs perceptual discrimination attention/memory task as well as a continuous motor driving task. Performance on these tasks are assessed in isolation and when performed together to calculate a performance index for each individual user. A personalized multitask treatment regimen is automatically configured and delivered to the user and is optimized adaptively to increase multitask performance. As players proceed through the treatment periodic recalibration occurs to maintain an optimal difficulty level."
15874885|NCT03844256|Combination Product|nivolumab 480mg|Immuno-chemoradiotherapy
15874886|NCT03844256|Combination Product|nivolumab 3mg/kg, ipilimumab 1mg/kg|Immuno-chemoradiotherapy
15874887|NCT03844256|Combination Product|nivolumab 1mg/kg, ipilimumab 3mg/kg|Immuno-chemoradiotherapy
15874888|NCT03844243|Drug|NGF|Intramuscular injection
15874889|NCT03844243|Drug|Isotonic-saline|Intramuscular injection
15874890|NCT03844230|Other|Control - Inhibition|Taste and spit up water 10 minutes before drinking a glucose load
15874891|NCT03844230|Other|Experimental I- Inhibition|Taste and spit up water 10 minutes before drinking a glucose load mixed with lactisole
15874892|NCT03844230|Other|Experimental II- Inhibition|Taste and spit up sucralose 10 minutes before drinking a glucose load mixed with lactisole
15874893|NCT03844230|Other|Control- Stimulation|Taste and spit up water 10 minutes before drinking a glucose load
15874894|NCT03844230|Other|Experimental I- Stimulation|Taste and spit up sucralose 10 minutes before drinking a glucose load
15874895|NCT03844230|Other|Experimental II- Stimulation|Drink sucralose 10 minutes before drinking a glucose load
15874896|NCT03844230|Other|Sensory Evaluation|Taste different solutions to evaluate sweet taste preference, suprathreshold intensity and detection threshold
15874897|NCT03844217|Drug|Macimorelin 0.5mg/kg body weight|oral Macimorelin stimulation test with the dose of 0.5mg/kg body weight Macimorelin
15874898|NCT03844217|Drug|Macimorelin 0.75mg/kg body weight|oral Macimorelin stimulation test with the dose of 0.75mg/kg body weight Macimorelin
15874899|NCT03844204|Device|Thermal servo-controlled system|All patients will be positioned under the infant warmer. In the treatment group, a probe positioned on the skin of the neonate will guide the thermal exposure in a servo-controlled modality. In the control group, thermal exposure will be determined manually by setting the power of the heater at the maximum output.
15874900|NCT03844191|Drug|RUC-4 Compound|single subcutaneous administration of RUC-4
15874901|NCT03844178|Procedure|The option for compensation of Pupil centroid shift was ON|The option for compensation of Pupil centroid shift was ON
15874902|NCT03844178|Procedure|The option for compensation of Pupil centroid shift was OFF|The option for compensation of Pupil centroid shift was OFF
15874903|NCT03844178|Drug|installation of Tetracaine 1%|installation of Tetracaine 1%
15874904|NCT03844178|Procedure|Photorefractive keratectomy (PRK)|periorbital skin will be prepared with povidone iodine 5%. Iris registration will be performed in all eyes before epithelial removal. Ethylalcohol 20.0% into a 9.0 mm well for 20 seconds will be applied on the central cornea, and then the epithelium of the central 9.0 mm area will be removed by hockey knife. Excimer laser ablation will be performed by Wavelight Allegretto EX500 (Alcon, Fort Worth, TX, USA)
15874905|NCT03844165|Behavioral|Diet change (red rice)|This interventions specifically aims to reduce liver inflammation, by replacing white rice in the diet with equal amounts of red rice and lentils. This will also enable for the research team to tests specific scientific hypotheses regarding the effects of diet on insulin resistance, liver pathology and the gut microbiome in NAFLD.
15874906|NCT03844165|Behavioral|Yoga|All 84 study participants take part in the yoga intervention. This is an intensive programme organized and delivered by experienced practitioners under direction of Dr Leena Mohan at the Holistic Health and Research Institute. This will evaluate whether physical activity alone improves metabolic health of the liver.
15874993|NCT03843437|Device|Tencel Therapeutic Garments|Children age 6 months to 3 years will wear a Tencel full body suit with feet and mittens, while children age 3-6 years will wear Tencel long-sleeve shirts and pants that do not cover the hands and feet. Children will wear the study garments at night but may also wear garments during the day if desired.
15874996|NCT03843424|Behavioral|FBT program|An intensive,comprehensive, behavioral intervention aligned with the US Preventive Services Task Force recommendations for childhood obesity screening and counseling.
15874907|NCT03844152|Dietary Supplement|Fermented whey concentrate|The investigated dietary supplement is a form of lacto-fermented whey concentrate (FWC), which has been deproteinised and then diluted (1/20) in sugar-free flavoured water to improve palatability. The main solute within the lacto-fermented whey is L-(+)-lactic acid (7%), produced through bacterial fermentation of the milk sugar lactose. The research team will provide non-descriptive bottles of drink to all volunteers. The flavour of the FWC will be masked by the flavoured water. In order to assess compliance and minimize an initial treatment effect, a 14 day run-in period during which only flavoured water is to be consumed will be completed by all volunteers. At the same time, this period will act as a wash-out, as volunteers will be asked to abstain from the use of any dietary supplements during this period and the rest of the study. The daily energy content of the FWC is 4kcal.
15874908|NCT03844139|Device|Feeding pump and glycerin syringe|The continuous group use feeding pump and the intermittent group use syringe to give dysphagia patients after stroke prescribed nutrition through nasogastric tube.
15874909|NCT03844126|Other|Transition classes|90 minutes spent with patients and their families (separately) to review the changes and challenges associated with healthcare transition and help alleviate some of the barriers traditionally associated with this process.
15874910|NCT03844113|Drug|Carnosine|Each participant will be given a daily oral dose 2 g of carnosine for 6 months
15874911|NCT03844113|Drug|Placebo|Each participant will be given a daily oral dose 2 g of methycellulose powder for 6 months
15874912|NCT03844100|Drug|efficacy and safety of CNU® Capsule|All subjects take 250mg CNU capsule orally 1 capsule per time, 2 times a day (morning, evening / at meal or after meal) for 12 weeks.
15874913|NCT03844087|Device|Multiplanar neuromuscular training|See arm description
15874914|NCT03844074|Biological|bevacizumab|1.25 mg, intravitreal injection
15874915|NCT03844074|Biological|ranibizumab|0.5mg, intravitreal injection
15874916|NCT03844061|Drug|Belimumab|Belimumab decreases B-Cell survival and has been FDA approved for the treatment of systemic lupus erythematosus, another rheumatic autoimmune disease. Belimumab is a recombinant, fully human monoclonal antibody; it binds to the soluble human B lymphocyte stimulator (BLyS) with high affinity and inhibits its biologic activity. The background above provides a robust rationale for the investigation of belimumab in the treatment of dcSSc.
15874917|NCT03844061|Drug|Rituximab|Rituxan® (rituximab) is a genetically engineered IgG1 kappa chimeric murine/human monoclonal antibody containing murine light- and heavy-chain variable region sequences and human constant region sequences. The antibody reacts specifically with the CD20 antigen found on the surface of malignant and normal B cells, and established B cell lines. Studies have shown that rituximab binds via its Fc domain to human complement and lyses lymphoid B cell lines by complement dependent cytotoxicity through the induction of apoptosis and via antibody-dependent cell mediated cytotoxicity. Rituximab is approved by the U.S. Food and Drug Administration (FDA) to treat some types of cancer, rheumatoid arthritis and vasculitis.
15874918|NCT03844061|Other|Placebo Subcutaneous Injection|Normal Saline
15874919|NCT03844061|Other|Placebo Infusion|Normal Saline
15874920|NCT03844061|Drug|MMF|MMF belongs to a group of medicines known as immunosuppressive agents. It is used with other medicines to lower the body's natural immunity.
15874922|NCT03844035|Diagnostic Test|Periimplant crevicular fluid (PICF) collection|Prior to PICF sampling, supragingival plaque was removed by sterile curets and, after air drying, the surfaces were isolated by cotton rolls. Filter paper strips (periopaper, proflow Inc., Amityville, New York, USA) were placed in sulcus for 30s. Care was taken not to avoid mechanical trauma and strips contaminated with blood or saliva were discarded. The absorbed PICF volume was estimated by a calibrated instrument (periotron 8000, proflow Inc., Amityville, NY, USA). Then, the strips were sealed into sterile tubes before freezing at -80⁰C. The readings were converted to an actual volume (µl) by reference to the standard curve.
15874923|NCT03844022|Diagnostic Test|MRI|magnetic resonance imaging
15874924|NCT03844009|Other|Computer integrated debriefing|At the end of each computer-based simulation, the participant had a computer integrated debriefing of his performance during the neonatal resuscitation simulation and a debriefing based on an auto-evaluation of his non-technical skills.
15874925|NCT03843996|Device|Treatment - Stratamed|To determine if Stratamed is more effective than standard of care therapy in limiting severity and duration of signs and symptoms of acute inflammation post follicular harvesting procedure.
15874926|NCT03843983|Device|Lipiflow® application|"Lipiflow® will be applicated in both lids of each eye during 12 minutes once. Firstly, a drop of anesthetic will be instilled in each eye. Then, while the participant stays with his eyes closed, a one-used applicator will be placed covering the subject's lid. The instrument applies heat and pressure in the lid during 12 minutes. Time frame: between 2 and 7 days after visit 1.
~Then, there will be 3 follow-up visits in 3, 6 and 12 months after treatment."
15874927|NCT03843970|Drug|Levobupivacaine Hydrochloride 0.5%|The solution is called L solution, which contains a combination of 0.5% isobaric levobupivacaine with fentanyl. Injectable Solution.
15874928|NCT03843970|Drug|Isobaric bupivacaine 0.5%|The solution is called B solution, which contains a combination of 0.5% isobaric bupivacaine with fentanyl. Injectable Solution.
15874929|NCT03843957|Other|mPATH-CRC|mPATH-CRC is a self-administered iPad program that patients use in primary care clinics to help them receive CRC screening. The mPATH-CRC program also includes health questions to assist clinics with patient check-in, thereby incentivizing its use for all patients.
15874930|NCT03843957|Other|"high touch Implementation strategy"|"The high touch strategy consists of pre-implementation activities, training, and ongoing support.
~Pre-Implementation Activities
~Clinic champion identified.
~Study team meeting with clinic champion
~Implementation adaptations as needed for clinic flow
~Implementation Kick-Off (Day 1)
~• On-site training with key clinic personnel
~Months 1 - 6
~Phone/email technical support, as needed.
~Access to web-based QA dashboard
~Monthly program usage report sent to clinic champions
~Scheduled phone-calls with clinic champion to review QA data and explore potential barriers.
~Implementation adaptations as needed for clinic flow
~Goal-triggered follow-up on-site trainings
~Additional on-site trainings as requested.
~Months 7 - 12
~Phone/email technical support, as needed
~Access to web-based QA dashboard"
15875063|NCT03842917|Other|Blood pressure measurement|Home blood pressure self-measurement and hospital blood pressure measurement
15875064|NCT03842904|Drug|Trimbow pMDI|Clinical Trial of an Investigational Medicinal Product (CTIMP)
15874933|NCT03843931|Behavioral|GLA:D|The GLA:D exercise and education program is an 8-week treatment program delivered by GLA:D certified physiotherapists. It consists of 2 educational sessions over 2 weeks (1/week in week 1 and 2) and 12 exercise sessions over 6 weeks (2/week in weeks 2 thru 8) The 2 educational sessions provide knowledge of OA, treatment and self-management, with a special focus on exercise and its benefits. The exercise part lasts for 6 weeks with 2 exercise sessions per week of approximately 1 hour (12 sessions total). The exercise sessions are group based at a facility supervised by a GLA:D certified physiotherapist. The goal is the obtain muscle control and stability in situations resembling daily life and/or more strenuous activities.
15874934|NCT03843931|Drug|Intra-articular saline injection|"Four [4] dosages of 5 ml intra-articular isotonic saline (0.9% (9 mg/mL) Sodium Chloride Injection (sterile, isotonic solution of sodium chloride and sterile water for injection)) every other week from baseline (week 1, 3, 5 and 7 = 4 injections).
~The injections will be carried out with a 21 gauge (38 mm) needle and a Luer-lock syringe under ultrasound guidance to ensure that the needle is inserted into the study knee joint cavity and document correct deposition of the bolus in the joint cavity.
~If the investigator detects presence of excessive joint fluid during the ultrasound guided preparation of the injection, this will be aspirated before injection of the saline - if possible."
15874935|NCT03843918|Drug|LAE001|LAE001 BID will be orally administered until the subjects develop disease progression, intolerable adverse events, or trial withdrawal decided by the investigator/subject. The LAE001 dose adopted for the phase II study will be based on the RP2D determined in the phase I study.
15874936|NCT03843918|Drug|Placebo|Placebo BID will be orally administered until the subjects develop disease progression, intolerable adverse events, or trial withdrawal decided by the investigator/subject. The placebo dose adopted for the phase II study will be same as LAE001 (RP2D dose).
15874937|NCT03843905|Other|no intervention|The aim of this translational research project is to study the impact of these new prognostic tools on surgical and oncologic results in a prospective cohort of patients who underwent CRC surgery at the Digestive Surgery Department of the University Hospital of Clermont-Ferrand (France)
15874938|NCT03843892|Drug|OFEV|twice daily
15874939|NCT03843879|Procedure|Transversus Abdominis Plane Block|Single-injection transversus abdominis plane block with 30 mL of 0.25% Bupivacaine with 1:400,000 epinephrine
15874940|NCT03843879|Drug|Intravenous Lidocaine|Continuous intravenous lidocaine infusion
15874941|NCT03843866|Other|4-0 Monocryl|sutures and steri-strips
15874942|NCT03843866|Other|Adhesive Glue|Adhesive Glue
15874943|NCT03843853|Drug|Pemetrexed|Pemetrexed 500 mg/m2 d1
15874944|NCT03843853|Drug|S-1|S-1 (20mg、25mg), capsule, 40~60mg, Bid,p.o, d1~14
15874945|NCT03843853|Drug|Bevacizumab|Bevacizumab 7.5 mg/kg d1
15874946|NCT03843840|Device|Combined Coaxial Optical Coherence Tomography|Taking images of the retina with two wavelengths
15874947|NCT03843827|Device|Laryngeal Mask Airway|The aim of this study is to compare between cLMA and I gel regarding insertion success rate, the time of insertion, leaking pressure, assessment of position by fiber optic, hemodynamic, Spo2 for each device during insertion and maintenance of general anaesthesia and postoperative complications in obese patients
15874948|NCT03843827|Device|I gel Airway|I gel is a new type of laryngeal mask and doesn't have an inflatable cuff. Because of its thermoplastic elastomer structure, it exactly adapts to the supraglottic tissue by binding with body temperature, thus minimising air leakage
15874949|NCT03843814|Procedure|APT MRI|
15874950|NCT03843801|Device|Endomina|The intervention will be performed under general anesthesia with tracheal intubation. Endomina will be introduced into the stomach over guide wires and then fixed to the endoscope. The procedure will include the placement of transmural anterior-posterior sutures in the stomach in order to achieve a gastric remodelling. Patient will be kept overnight after the procedure.
15874951|NCT03843788|Device|Transcutaneous Electrical Nerve Stimulation (TENS)|Starting 8 hours after cesarean section, the TENS unit will be applied with charges above and below the incision. The device will be set to high frequency (>75 Hz) for pain relief. Intensity of stimulation will be set to patient threshold using the forearm as a guide. Stimulation will be turned on titrated to the level which is felt but not painful for the patient. It will remain on until the patient is discharged, to be removed for toilet and showering at the patient's discretion. Once the TENS unit is applied and turned on, the patient will not have to do anything else to maintain the therapy.
15874952|NCT03843775|Drug|Binimetinib|Dose level 1 binimetinib 45 mg PO BID. Dose level 2 binimetinib 60 mg oral BID
15874953|NCT03843775|Drug|Encorafenib|encorafenib 450 mg oral QD
15874954|NCT03843749|Drug|Pyrotinib|Pyrotinib in Combination With Trastuzumab
15874955|NCT03843736|Behavioral|Lifestyle intervention|"Balance the diet;
~Limit high-calorie and high-fat food intake, reduce eating out, and establish regular eating habits;
~Monitor body weight, avoid sedentary, get more sun and regular activities;
~Mental health regulation."
15874956|NCT03843736|Drug|Probiotic Agent|Patients have to take a probiotic powder (product name: Tangwen Tai, lactobacillus plantarum LP45 + Lactobacillus acidophilus La28 + Bifidobacterium lactobacillus BAL531) twice a day for three months.
15874957|NCT03843736|Drug|Oral contraceptive|The patient needs to take drospirenone ethinyl estradiol tablets (trade name: Yousi Yue) 1 tablet daily for 3 months.
15874958|NCT03843723|Other|Pre-flight evaluation|All the participants receive the interventions as part of their routine medical care during their annual visit for CF follow-up. Oxygen saturation are measured by pulse oximetry. Exercise testing is performed by 6MWT and CPET. Pre-flight evaluation is performed by HAST.
15874959|NCT03843710|Drug|Gold Nanocrystals|CNM-Au8 is a dark red/purple-colored liquid formulation consisting of a stable suspension of faceted clean surfaced elemental gold nanocrystals in buffered deionized water with a concentration of up to 0.5 mg/mL of gold. The formulation is buffered by sodium bicarbonate present at a concentration of 0.546 mg/mL. There are no other excipients. The drug product is formulated to be taken orally and will be provided in single dose HDPE containers. The study doses vary by the concentration of gold nanocrystals per milliliter in a volume of 60 mL.
15874994|NCT03843437|Device|Cotton Therapeutic Garments|Children age 6 months to 3 years will wear a cotton full body suit with feet and mittens, while children age 3-6 years will wear cotton long-sleeve shirts and pants that do not cover the hands and feet. Children will wear the study garments at night but may also wear garments during the day if desired.
15875065|NCT03842904|Drug|Fostair pMDI|Clinical Trial of an Investigational Medicinal Product (CTIMP)
15874960|NCT03843697|Device|An App for reminding patients to take their medication|Open-label, single-center study, up to 20 adults (>18) male and female with inflammatory bowel disease (chorn's disease, ulcerative colitis), unresponsive to biological drugs, will participate in a 4-week observation period during which no change in drugs is permitted. The patients will then begin 10-week treatment by taking their medications according to a semi-random schedule that is pre-set for them by the physician using the same drugs the patient is taking and only changing the dose and times of taking them each day while keeping the drugs within their therapeutic window.
15874961|NCT03843684|Device|3D-printed foot orthoses|3D printed foot orthoses with arch support
15874962|NCT03843684|Device|5 degrees lateral wedge insoles|Insoles with a lateral inclination set at 5 degrees
15874963|NCT03843671|Drug|Hyperbaric oxygen|Hyperbaric oxygen therapy
15874964|NCT03843671|Device|Hyperbaric chamber|Hyperbaric chamber
15874965|NCT03843658|Other|There is no intervention, but a diagnosis.|Cohorts will be determined by the primary rheumatology diagnosis.
15874966|NCT03843645|Procedure|general anesthesia|surgical procedure under general anesthesia
15874967|NCT03843645|Procedure|regional anesthesia|surgical procedure under regional anesthesia
15874968|NCT03843632|Biological|VARIVAX™|VARIVAX™ administered by SC injection as 0.5 mL Varicella Virus Vaccine Live in sterile suspension on Day 1 (all participants) and Day 43 (adult and adolescent participants).
15874969|NCT03843606|Other|Modified ketogenic diets|Different diet composition
15874970|NCT03843593|Behavioral|Demographics Questionnaire|A brief questionnaire will collect basic demographic information (i.e., age, gender, racial background, ethnicity, employment status, marital status) at time of enrollment.
15874971|NCT03843593|Behavioral|Adjuvant Treatment Beliefs Scale10|This brief PRO measure asks patients to indicate the likelihood, using a 5-point Likert type scale (1 [definitely not], 2 [probably not], 3 [maybe], 4 [probably], 5 [definitely]) of six positive (e.g., reduced risk of recurrence, greater chance of being cured) and five negative outcomes (e.g., side effects, health status) of adjuvant treatment.
15874972|NCT03843593|Behavioral|Functional Assessment of Cancer Therapy - Melanoma (FACT-M)11|FACT-M is a 51-item patient-self report measure for the assessment of quality of life (QOL) in patients with American Joint Committee on Cancer stages I through IV melanoma.
15874973|NCT03843593|Behavioral|Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - General (FACIT-TS-G)13|FACIT-TS-G is a brief, 8-item self-administered measure designed to assess general treatment satisfaction in patients.
15874974|NCT03843593|Behavioral|Decisional Regret14|This is a set of 5 questions examining level of regret for treatment decisions (in this case, decision to pursue adjuvant therapy), with answers scored on a 5-point Likert-type scale (i.e., 1 [Strongly Agree], 2 [Agree], 3 [Neither Agree Nor Disagree], 4 [Disagree], 5 [Strongly Disagree].
15874975|NCT03843593|Behavioral|Clinician Preference for Treatment|This is a single item to be completed by Medical Oncologists that will indicate their preference as to whether they prefer that their patient accepts adjuvant therapy.
15874976|NCT03843580|Device|optiflow|we use Transnasal Humidified Rapid-Insufflation Ventilatory Exchange (thrive-optiflow) during general anesthesia for suspension laryngoscopy
15874977|NCT03843567|Other|Endoscopic characterisation training|"Included in the training material is an overview of Resect and Discard, endoscopic platforms (NBI, BLI and i-Scan), NICE classification, SIMPLE classification, BASIC classification and example still images and videos of both classifications in use. Still images will be used to ensure participants have the best opportunity to observe and learn Kudo Pit Patterns and other polyp features without movement artefact before observing videos, which are more challenging to interpret. The training will last approximately 1 hour."
15874980|NCT03843541|Drug|N-acetylcysteine (NAC) 600 mg|NAC will be administered twice a day, morning and evening, during treatment period.
15874981|NCT03843541|Drug|Ambroxol hydrochloride 30 mg|Ambroxol hydrochloride will be administered twice a day, morning and evening, during treatment period.
15874982|NCT03843541|Other|placebo|Placebo will be administered twice a day, morning and evening, during treatment period.
15874983|NCT03843528|Drug|Vorinostat|Vorinostat will be administered concurrent with low-dose azacitidine post-transplant, on days 1-7 and 15-21 of 28 day cycles. This is an oral medication.
15874984|NCT03843528|Drug|Azacitidine Injection|Azacitidine will be administered on days 1-5 of each 28 day cycle, either by IV or subcutaneous injection. The dose of azacitidine will be fixed, with no dose-escalation.
15874985|NCT03843515|Drug|Nivolumab|Neoadjuvant nivolumab flat dose 400mg
15874986|NCT03843502|Drug|Kava Dietary Supplement|Participants will be given three 75mg kava capsules.
15874989|NCT03843476|Device|Patient Specific Rod|Posterior spinal fusion rod
15874990|NCT03843463|Drug|Escitalopram 10mg|Escitalopram tablet
15874991|NCT03843463|Drug|Placebo|Sugar pill manufactured to mimic escitalopram 10 mg tablet
15874992|NCT03843463|Behavioral|Computer-delivered naming treatment|15 45-minute sessions of computer-delivered naming treatment beginning two months following stroke
15874995|NCT03843424|Behavioral|eSOC program|American Medical Association (AMA) recommended staged approach to childhood obesity screening and counseling
15888388|NCT03740165|Biological|Bevacizumab|IV infusion
15874997|NCT03843398|Procedure|Colorectal cancer resection via minilaparotomy|According to the cancer location, a 7 cm incision is made in specific area of the patient's abdomen. The whole procedure of operation will be finished within this incision. If the incision must be lengthen due to the surgical demand, the failure of the minilaparotomy is determined.
15874998|NCT03843398|Procedure|Laparoscopic colorectal cancer resection|This is one of the routine procedures used for colorectal cancer resection.
15874999|NCT03843385|Drug|encapsulated faecal microbiota filtrate|Multidonor stool mixed with sterile normal saline, homogenized, filtered, centrifuged, air pressure filtered, encapsulated in hypromellose capsules and frozen.
15875000|NCT03843385|Drug|encapsulated faecal microbiota|Multidonor stool mixed with sterile normal saline, homogenized, filtered, encapsulated in hypromellose capsules and frozen.
15875001|NCT03843385|Drug|Placebo|Sterile saline encapsulated in hypromellose capsules and frozen.
15875002|NCT03843372|Device|High flow nasal cannula|All of participants will be received one night high flow nasal cannula and another night for continuous positive airway pressure.
15875003|NCT03843359|Drug|GSK3745417|GSK3745417 will be administered.
15875004|NCT03843359|Drug|Dostarlimab|Dostarlimab will be administered.
15875005|NCT03843333|Behavioral|Tai Ji Quan: Moving for Better Balance|TJQMBB is an evidence-based, Centers for Disease Control and Prevention (CDC)-recommended, group falls prevention program based in Tai Chi that has been shown to reduce falls risk, improve physical function, and improve cognition. The program is delivered in 1-hour sessions twice weekly over 24 weeks, with the first 12 weeks spent learning the basic Tai Ji Quan forms and the second 12 weeks focused on variations in practice that progressively increase physical and cognitive demands. A physical therapist at Dartmouth is an authorized TJQMBB trainer and will train the CHWs to deliver the intervention and provide remote supervision monthly.
15875006|NCT03843333|Behavioral|Behavioral Activation|BA is a brief intervention for depressive symptoms that focuses on engagement in positively-reinforcing activities and decreasing activity avoidance. CHWs will be trained by Dartmouth psychologists to deliver a brief behavioral activation program to encourage participants to increase their involvement in meaningful activities. BA will be delivered in one-hour sessions in the home every other week for 12 weeks. Supervision will be provided remotely on a weekly basis.
15875007|NCT03843333|Other|Resource Navigation|CHWs will assess participants' unmet psychosocial needs and assist them in identifying and connecting them with resources to address these needs.Types of assistance may include identifying transportation services, assisting with applications for benefits, linking participants to Meals on Wheels and other local food resources, and connecting participants to community programs for older adults. We expect that participant needs and services delivered will vary and acknowledge that this intervention component will not be standardized due to the nature of this work.
15875008|NCT03843333|Other|Enhanced Usual Care|Comparison participants will receive a detailed resource guide on community supports for older adults. The research team will facilitate referrals to local resources (e.g. the Dartmouth Aging Resource Center) if desired by participants. Data from research assessments of cognition, depressive symptoms, mobility, and functional status will be provided to the primary care team for follow-up and intervention as needed.
15875009|NCT03843320|Device|SAPIEN 3|Transcatheter aortic valve replacement
15875010|NCT03843320|Device|SAPIEN XT|Transcatheter aortic valve replacement
15875011|NCT03843320|Device|INSPIRIS RESILIA|Surgical aortic valve replacement
15875012|NCT03843320|Device|EDWARDS INTUITY|Surgical aortic valve replacement
15875013|NCT03843320|Device|Carpentier-Edwards PERIMOUNT Magna-Ease|Surgical aortic valve replacement
15875014|NCT03843307|Device|Avazzia Tennant Biomodulator® PRO|High-voltage pulsed current (HVPC) electrical stimulation with Reactions and BEST™ (Bio-Electric Stimulation Technology) microcurrent that measure and change with tissue electrical characteristics.
15875015|NCT03843294|Biological|TAA-T cells|The patient will receive two TAA-T cell infusions given 2 weeks apart. TAA-T cell dose: 2 x 107 cells/m2.per infusion.
15875016|NCT03843294|Drug|Nivolumab|Nivolumab: For patients <18 years, 3 mg/kg/dose (maximum 240mg/dose) every 2 weeks. For adult patients ≥18 years, a dose of 240mg every 2 weeks or 480mg every 4 weeks
15875017|NCT03843281|Drug|Paracetamol|s. above
15875018|NCT03843281|Drug|Placebo|s. above
15875019|NCT03843281|Drug|Morphine|s. above
15875020|NCT03843268|Device|AMPS Gondola|Gondola is a portable device that runs on batteries and is fitted on both patient's feet when the patient is lying down. The device has been designed for the stimulation of two areas of both feet (first toe and metatarsal) through mechanical impulses set up for pressure, duration and sequence (Automated Mechanical Peripheral Stimulation - AMPS); the treatment requires less than 2 minutes.
15875021|NCT03843268|Device|Sham Gondola|The Sham treatment consist in the stimulation of the same areas through mechanical impulses different for pressure since attached to the steel stick point is positioned a rigid plastic circle with a diameter (12mm); thanks to this the induced pressure ishence lower and the surface contact bigger
15875022|NCT03843255|Other|Part 1: DCM Cohort|Patients with a confirmed diagnosis of DCM will have samples that undergo whole genome sequencing and biomarker analysis
15875023|NCT03843255|Other|Part 2: Heritable CV Diseases and Family Members|Biomarker analysis will be undertaken on samples
15875024|NCT03843242|Device|Pacemaker with Fixed long AV delay|Fixed AV delay was applied in the first 3 months of pacemaker implantation according to previously proposed definition.
15875025|NCT03843242|Device|Pacemaker with VpS® algorithm on|"After first 3 months of pacemaker implantation, the patients will be randomized into two groups (Vp-suppression algorithm on group vs. IRS-plus algorithm on group) using a centralized randomization system.
~In Vp-suppression algorhithm on group, Vp suppression algorithm of Enitra 8 DR-T pacemaker will be turned on at 3month visit after enrollment.
~The patient will be followed at 3-month after enrollment and at 6-month and 12-month after applying the specific algorithm."
15875026|NCT03843242|Device|Pacemaker with IRSplus algorithm on|"After first 3 months of pacemaker implantation, the patients will be randomized into two groups (Vp-suppression algorithm on group vs. IRS-plus algorithm on group) using a centralized randomization system.
~In IRS-plus algorithm on group, IRS plus algorithm of Enitra 8 DR-T pacemaker will be turned on at 3 month visit after enrollment.
~The patient will be followed at 3-month after enrollment and at 6-month and 12-month after applying the specific algorithm."
15875129|NCT03842319|Other|Diet evaluation|Biochemical analysis and questionaries for diet adherence and exercise registration
15875027|NCT03843229|Drug|Cinobufacini injection|The treatment group receives Cinobufacini injection 20ml via hepatic artery during TACE operation , Cinobufacini injection 20ml+5% Glucose injection 500ml from the second day of TACE until 7th day, and Cinobufacini tablet 3 tablets Tid for 2 months.
15875028|NCT03843229|Procedure|Transarterial Chemoembolization(TACE)|TACE consists of an injection containing a mixture of chemotherapeutic agents and lipiodol followed by embolization with polyvinyl alcohol (PVA) particles until complete stasis was achieved in the tumor-feeding vessels.Tumor-feeding vessels should be selected/superselected whenever possible.
15875029|NCT03843229|Drug|cinobufacini tablet|The treatment group receives Cinobufacini injection 20ml via hepatic artery during TACE operation , Cinobufacini injection 20ml+5% Glucose injection 500ml from the second day of TACE until 7th day, and Cinobufacini tablet 3 tablets Tid for 2 months.
15875030|NCT03843216|Other|observation|patients not treated
15875031|NCT03843216|Other|Physiotherapic scoliosis specific exercise|Specific exercise according to the SEAS (Scientific Exercises Approach to Scoliosis) protocol
15875032|NCT03843216|Device|brace|different kind of braces being elastic, rigid or very rigid. All devices are custom made. The hours of application per day varied from 18 to 24h.
15875033|NCT03843203|Device|Transcranial Direct Current Stimulation - tDCS|- Intervention: tDCS is a therapeutic method that modulates the membrane potential, where anodic stimuli induce cortical excitability and cathodic stimuli reduce it
15875034|NCT03843190|Behavioral|Take of Pounds Sensibly (TOPS)|Peer led
15875035|NCT03843177|Other|No intervention|No intervention will be performed. Only assessment will be done.
15875036|NCT03843151|Drug|BI 1358894|tablet
15875037|NCT03843151|Drug|Itraconazole|oral solution
15875039|NCT03843112|Drug|Vivag Plus|Contains two lactobacilli strains; l. gasseri and l. rhamnosus
15875040|NCT03843112|Drug|Placebo - Cap|Vaginal supplements
15875041|NCT03843099|Behavioral|Behavioral Weight Loss + Future Thinking|Participants will receive a 4-week behavioral weight loss intervention based on evidence-based weight loss strategies focused on diet, exercise, and behavioral skills.
15875042|NCT03843099|Behavioral|Behavioral Weight Loss + Healthy Thinking|Participants will receive a 4-week behavioral weight loss intervention based on evidence-based weight loss strategies focused on diet, exercise, and behavioral skills.
15875043|NCT03843086|Device|Low Intensity Linear Shockwave Device for the treatment of Erectile Dysfunction|"This is a prospective, randomized, clinical study aimed to evaluate the safety and efficacy of the two treatment schedules on symptomatic erectile dysfunction patients using low intensity shockwave therapy. The patients are randomized in a 1:1 ratio into two active treatment groups.
~Group A: 5 daily sessions within a week (Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura).
~Group B: Three sessions per week (Monday, Wednesday, Friday) for 2 consecutive weeks, in which 600 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura)"
15875044|NCT03843073|Device|Connected Urinary Catheter|Patients will use the Connected Catheter to empty the bladder during the course of treatment.
15875045|NCT03843060|Drug|AZD9977|Participants will receive single AZD9977 (Dose 1) capsule orally once daily in fed state, on Day 1 followed by at least 3 days washout period.
15875046|NCT03843060|Drug|Itraconazole|Participants will receive Itraconazole daily (Dose 2) capsule orally once daily from Day 4 to Day 8 plus will be administered AZD9977 (Dose 1, fed state) as a single dose on Day 7. Dose of itraconazole has to be taken at -1 hour (1 hour prior to AZD9977 dosing) when co-administered with AZD9977.
15875047|NCT03843047|Drug|3 mg/mL nicotine strength e-liquid|Availability of 3 mg/mL nicotine strength e-liquid in the Experimental Tobacco Marketplace
15875048|NCT03843047|Drug|6 mg/mL nicotine strength e-liquid|Availability of 6 mg/mL nicotine strength e-liquid in the Experimental Tobacco Marketplace
15875049|NCT03843047|Drug|12 mg/mL nicotine strength e-liquid|Availability of 12 mg/mL nicotine strength e-liquid in the Experimental Tobacco Marketplace
15875050|NCT03843047|Drug|24 mg/mL nicotine strength e-liquid|Availability of 24 mg/mL nicotine strength e-liquid in the Experimental Tobacco Marketplace
15875051|NCT03843034|Genetic|Measure endometrial markers|Endometrial biopsies will be taken from participants in both groups
15875052|NCT03843021|Other|VAD Infection Prevention Survey|Healthcare providers caring for VAD Therapy recipients will answer questions regarding processes of care at their institutions.
15875053|NCT03843008|Dietary Supplement|Melatonin|Participants in the Melatonin Group will receive 3mg of melatonin each evening for up to seven days for a maximum total of 21mg of melatonin.
15875054|NCT03842995|Behavioral|Genetic Counselor|Standard of Care
15875055|NCT03842995|Behavioral|Trained Healthcare Provider|Neonatologists and Neonatology Nurse Practitioners that receive training to deliver whole genome sequencing results
15875058|NCT03842956|Procedure|Primary wound closure in Allgower Technique vs. secondary open wound healing of pin-sides after removal of the fixated-externe|We compare the outcome of primary wound closure (Allgower) and secondary open wound healing by comparing infection-rates, use of antibiotics, reoperation-rates, satisfaction of the patients and optical results using the Vancouver scar scale
15875059|NCT03842943|Drug|Pembrolizumab|Preoperative infusions
15875060|NCT03842943|Drug|Talimogene Laherparepvec|Preoperative intralesional injection
15875061|NCT03842930|Procedure|Endovascular embolization|Endovascular embolization of the Lumbar Arteries
15875062|NCT03842917|Other|Biological samples|Urine and blood samples
15888389|NCT03740165|Drug|Docetaxel|IV infusion
15875067|NCT03842852|Procedure|Inguinal hernia repair|The grupo one underwent open repair and laparoscopic repair
15875068|NCT03842839|Drug|Tiotropium|Tiotropium will be used once daily for 2 years.
15875069|NCT03842839|Drug|Olodaterol / Tiotropium|Tiotropium or dual bronchodilators will be used, (including but not limited to Olodaterol / Tiotropium) will be used once daily for 2 years.
15875070|NCT03842826|Diagnostic Test|Palpation, resistance and stretch tests|Palpation, resistance and stretch tests performed by 2 blinded examiners.
15875071|NCT03842813|Device|DES-CRE8|Polymer-free Amphilimus™ (Sirolimus + Fatty Acid) eluting coronary stent. The absence of the polymer minimizes the risk of inflammation/thrombosis, while the propriety formulation enhances drug absorption.
15875072|NCT03842800|Other|MRI|Patients and volunteers will receive an MRI.
15875073|NCT03842800|Drug|Ketamine|Ketamine will be administered to a subset of healthy controls that agree to receive the drug as part of receiving an MRI.
15875074|NCT03842787|Other|Biological analysis|"Biological and research analysis:
~Quantification of ficolin-3, anti-ficolin-3 antibodies, ficolin-2, anti-ficolin-2 antibodies
~Purification of patients' antibodies (anti-ficolin-3 and -2)
~Evaluation of effects of anti-ficolin-3 and anti-ficolin-2 purified antibodies Investigation of ficolin-3 and ficolin-2 deposition in renal biopsy"
15875075|NCT03842774|Dietary Supplement|Exract of Gelidium elegans|Exract of Gelidium elegans will be given to the test group.
15875076|NCT03842774|Dietary Supplement|Placebo|Placebo supplement will be given to the test group.
15875077|NCT03842761|Drug|BI 685509|Tablet
15875078|NCT03842761|Drug|Placebo|Tablet
15875079|NCT03842735|Other|exercise and rehabilitation counselling|The intervention consists in a standardized physical exercise (PE) and rehabilitation counselling indications (RCI). PE is done 5 days/week (2 days in autonomy by the patient with parents support and 3 days supervised). Each session lasts 30 minutes and this is supervised by one therapist for all patients. Patients are enrolled in an EP composed by three different types of exercises, each carried out for 10 minutes per session: muscle strength exercises for upper and lower extremities preceded by warming up, aerobic exercises and stretching. The kind of exercise is differentiated by age range (children, 5-12 years and adolescents, 13-18 years).
15875080|NCT03842735|Behavioral|rehabilitation counselling|RCI, which have to be followed daily, consist in some practical advice was given on how to adopt an active lifestyle during the recovery (e.g., getting up to go to the bathroom, getting up to move to the window to talk with visitors, sit on chair to have school lessons).
15875081|NCT03842722|Device|Protoporphyrin IX - Triplet State Lifetime Technique|Protoporphyrin IX - Triplet State Lifetime Technique is a way to measure mitochondrial oxygen tension in a non-invasive way at bedside.
15875082|NCT03842709|Drug|Pramipexole Oral Tablet|Initial dosage of 0.125 mg pramipexole daily, potentially titrated upward in 0.125 increments to a maximum of 0.5 mg daily, for 4 weeks.
15875083|NCT03842709|Other|Placebo|Administration of placebo
15875084|NCT03842696|Drug|Vorinostat|Vorinostat 30, 45 or 60 mg/m2 BID (100 mg/m2 BID maximum) PO from 10 days prior to transplant (day -10), until day +100 post-transplant (110 total days of dosing).
15875085|NCT03842696|Procedure|Blood and Marrow Transplant (BMT)|Undergo allogeneic BMT according to local site institutional practice.
15875086|NCT03842696|Drug|Tacrolimus (or cyclosporine)|Tacrolimus (or cyclosporine if tacrolimus becomes in shortage during the study period) will begin on day -3. Intravenous or oral dosing is permitted.In the absence of GVHD, it is recommended that tacrolimus or cyclosporine tapering begin on day +100 post-transplant as per local site BMT program clinical practice guidelines. In the presence of GVHD, it is recommended that tacrolimus or cyclosporine be continued at therapeutic dosing.
15875087|NCT03842696|Drug|Methotrexate|Methotrexate will be used in combination with tacrolimus (or cyclosporine) for standard GVHD prophylaxis. It will be given at a dose of 5 mg/m2/dose once daily intravenously on days +1, +3, +6, and +11. Standard criteria for administration will be followed per local site institutional BMT program clinical practice guidelines.
15875088|NCT03842683|Other|CGM|This study seeks to assess CGM accuracy and develop prediction models for hypoglycemia detection and no intervention is therefore applied.
15875089|NCT03842670|Behavioral|Cognitive Behavior Therapy|The CBT condition will include 8 weekly, 60-minute sessions, and will be delivered according to the Epstein & McCrady (2009) cognitive-behavioral treatment manual, excluding material provided in the platform treatment. The treatment manual and accompanying client workbook provide detailed therapist instructions for each session, client exercises, worksheets, and homework assignments. The treatment focuses on cognitive and behavioral coping skills training, and emphasizes problem-solving as an overall approach to dealing with drinking. Treatment sessions may be audio-recorded for supervision and to ensure that the treatment is being delivered as intended.
15875090|NCT03842670|Behavioral|Mindfulness Based Relapse Prevention|The MBT condition will be adapted from the 8-week version of the mindfulness-based relapse prevention (MBRP) manual (Bowen et al., 2011; Witkiewitz et al., 2005). The main adaptation will be to eliminate the relapse prevention/CBT components and focus attention on mindfulness practices. The mindfulness practices in MBT are designed to increase awareness of triggers and decrease reactivity to distress or discomfort in the presence of triggers (Witkiewitz & Bowen, 2010). The relevant worksheets and homework assignments focusing on mindfulness tools will be maintained from the MBRP manual. Treatment sessions may be audio-recorded for supervision and to ensure that the treatment is being delivered as intended.
15875091|NCT03842657|Combination Product|anticoagulation of the dialysis circuit|Each patient included in this study will receive two heparin-free dialysis sessions with heparin-grafted membrane (control group) or RCA with calcium-free citrate-containing dialysate and calcium reinjection according to the ionic dialysance (experimental group), alternatively
15875092|NCT03842644|Device|Tension reduction device|Continue using this device for 3 months post surgery.
15875093|NCT03842631|Drug|Timolol Maleate 0.5% Oph Soln|External use of 0.5% Timolol Maleate Drops for all patients in different depths of IH lesion.
15875094|NCT03842605|Other|Strength training|
15888862|NCT03736616|Drug|Ifosfamide|Chemotherapy
15875095|NCT03842592|Diagnostic Test|Treadmill Stress test|Ventricular arrhythmia will be assessed by ECG Holter and during treadmill stress test, both being performed 3 months and 1 year after acute myocarditis
15875096|NCT03842579|Other|Resistance training|Supervised progressive explosive type heavy-resistance training two times per week
15875097|NCT03842579|Other|High-protein diet|Daily supplementation with milk-based protein-rich products
15875098|NCT03842579|Other|Recommendations|Provided with the official national recommendations on nutrition
15875099|NCT03842553|Other|No Intervention: anonymous online survey|
15875100|NCT03842540|Behavioral|SpeakOut|"SpeakOut aims to increase social communication about contraception between adolescent IUD and implant users and their peers. SpeakOut has four components:
~Coaching session. Research staff will deliver a script to encourage recipients to share information about their contraceptive method with peers.
~Digital materials for recipients to keep and/or share with friends.
~Websites with information and resources. Staff will refer recipients to a website, either SpeakOutIUD.org or SpeakOutImplant.org, which contain information about their method.
~Text messages with information about recipients' method and about how to share their experience. Recipients will be given the opportunity to sign up for text messages that will be sent for 8 weeks following receipt of SpeakOut."
15875101|NCT03842540|Behavioral|PartyWise|The active comparator intervention is an alcohol assessment and education intervention using an SBIRT (Screening, Brief Intervention, and Referral to Treatment) framework. Staff will ask two screening questions developed by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the American Academy of Pediatrics to screen for adolescents potentially at risk. Using a script based on tenets of motivational interviewing to assess alcohol related consequences, the staff will guide teens in identifying personally relevant motivators for healthier behaviors, assess readiness to change, and offer educational materials and referrals.
15875102|NCT03842527|Device|Ultrasound|Gastric ultrasound of the stomach antrum to assess contents 1 hour prior to C-section surgery. Scans will be completed in both supine (lying on back) and right lateral decubitus (positions) positions. The completion of both scans will take 5-10 minutes total
15875103|NCT03842514|Dietary Supplement|Soya lecithin|The lecithin supplement will be soya lecithin granules given as 7.5 g twice daily, incorporated into juices
15875104|NCT03842501|Dietary Supplement|Release Supplement|Calorie reduced diet plus Release supplement
15875105|NCT03842501|Dietary Supplement|Placebo|Calorie reduced diet plus Placebo
15875106|NCT03842488|Drug|Experimental: RAL QD|Prescription of 2x RAL 600mg (1200MG) once daily
15875107|NCT03842488|Drug|Active comparator: DRV/cb|Prescription of DARUNAVIR/COBICISTAT 800 Mg-150 Mg once daily
15875108|NCT03842475|Procedure|Roux-en-Y gastric bypass (RYGB)|Bariatric surgery
15875109|NCT03842462|Other|nCPAP|infants receive primary non-invasive respiratory support by mean of nCPAP
15875110|NCT03842462|Other|NIPPV|infants receive primary non-invasive respiratory support by mean of NIPPV
15875111|NCT03842462|Other|NHFOV|infants receive primary non-invasive respiratory support by mean of NHFOV
15875112|NCT03842449|Diagnostic Test|BabyCO|An expired CO measurement will be performed by BabyCO and the result will be returned to the smoking pregnant woman by the consultant.
15875113|NCT03842449|Other|Biological samples|"The nature of the samples taken during the delivery are:
~maternal blood,
~cord blood
~placenta fragment"
15875114|NCT03842436|Device|Digital pill|Digital pills over encapsulating Truvada
15875115|NCT03842436|Drug|Truvada|Truvada prescribed with digital pills for PrEP
15875116|NCT03842423|Procedure|Brachial Plexus Anaesthesia|Regional anaesthesia for treatment of upper extremity injuries.
15875117|NCT03842410|Device|Single-Incision Sling|Solyx Single-Incision Sling for correction of stress urinary incontinence done in the office.
15875118|NCT03842397|Device|Kephalios Device 1|The Kephalios Device 1 is an adjustable annuloplasty ring, to be implanted by open surgery, having a hollow structure that comprises a flat rigid ring surrounding a deformable cage. The unique feature of the Kephalios Device 1 is that its annular shape and dimension can be finely adjusted percutaneously by an external actuator (three-balloon catheter) independently in the three areas corresponding to P1, P2 and P3
15875119|NCT03842384|Behavioral|distress tolerance training|The proposed intervention will initially target motivational processes in combination with introductory strategies for managing physical and emotional distress through a single, brief, computer-delivered session followed by eight weeks of theoretically-informed text messages intended to enhance motivation and promote distress tolerance.
15875120|NCT03842384|Other|treatment as usual|standard outpatient buprenorphine treatment
15875121|NCT03842371|Other|Metabolic level of BCAAs in monocytes and macrophages|Metabolic level of BCAAs in monocytes and macrophages
15875122|NCT03842358|Device|Hand-held hybrid probe|Consists of a commercially available US transducer located in the middle and near-infrared source and detector optical fibers distributed at the periphery
15875123|NCT03842332|Behavioral|Life Skills and Resilience Program|The 12 week life skills course includes resiliency modules that complement the strengths of participants as they progress toward the development and achievement of personal goals. The first module of the intervention engages youth through a caring/supportive relationship that sets these expectations. Activities are designed to support youth in identifying their existing strengths/skills. The second module explores, with youth, how they can apply and build upon their strengths/skills in the pursuit of self-generated goals. The third module is dedicated to building upon key problem solving skills that are especially important for young adults with autism, including conflict resolution and the management of stressors. The fourth module builds leadership capacity and self-advocacy skills.
15875124|NCT03842319|Other|Microbiota analysis|From the feces and oral cavity samples, the DNA of the microbiota will be extracted using specific extraction kits and the microbiome will be analyzed through the study of 16S ribosomal RNA amplicons.
15875125|NCT03842319|Other|Immunological analysis|A study of immunological cell populations, inmunogenetics and cytokines will be carried out from fresh blood samples using antibody panels and flow cytometry
15875126|NCT03842319|Other|Proteome analysis|A study of host and microbiota proteome will be carried out from samples using mass spectrometry
15875127|NCT03842319|Other|Metabolome analysis|A study of host and microbiota metabolome will be carried out from samples using MS-based as well as NMR-based methods
15875128|NCT03842319|Other|Clinical evaluation|Clinical evaluation including hemostasis and biochemical studies
15875130|NCT03842319|Other|MedDiet|The high-intensity Mediterranean diet will include the promotion of the following: a) abundant use of olive oil (>40 g/d) for cooking and dressing dishes; b) consumption of >2 daily servings of vegetables; c) >2-3 daily serving of fresh fruits; d) >3 weekly servings of legumes; e) >3 weekly servings of fish or seafood; f) >1 weekly serving of nuts or seeds; g) select white meats instead of red meats or processed meats; and h) cook regularly with tomato, garlic and onion adding or no other aromatic herbs, and dress vegetables, pasta, rice and other dishes with tomato, garlic and onion adding or no other aromatic herbs. Two main meals per day should be eaten (seated at a table, lasting more than 20 minutes). A recommendation to drink a glass of wine per day during meals is given. Limited consumption is advised for cured ham, red meat, chocolate, cured or fatty cheeses
15875131|NCT03842280|Device|Diaphragm ultrasound assessment & Esophageal pressure measurement|Diaphragm ultrasound assessment and/or Esophageal pressure measurement before, during and after spontaneous breathing trial
15875132|NCT03842267|Drug|Gemigliptin 50mg|"The subjects should visit a study site 9 times during the treatment period for about 52 weeks in total.
~Background therapy should be administered at the same time every day, keeping the same dosage administered before the study, according to the following criteria:
~Dapagliflozin 10 mg / day
~Metformin ≥ 1,000 mg / day"
15875133|NCT03842267|Drug|Gemigliptin Placebo|"The subjects should visit a study site 9 times during the treatment period for about 52 weeks in total.
~- The subjects should visit a study site 9 times during the treatment period for about 52 weeks in total.
~Background therapy should be administered at the same time every day, keeping the same dosage administered before the study, according to the following criteria:
~Dapagliflozin 10 mg / day
~Metformin ≥ 1,000 mg / day"
15875134|NCT03842254|Drug|Erythropoietin|Subcutaneous injection of erythropoietin 10,000 units
15875135|NCT03842241|Device|Non-custom made foot orthoses|Foot orthoses is an orthotic devices which are used to support arch and rear-foot and put it in a good alignment.
15875139|NCT03842215|Device|smart physical exam|Use smart physical exam to collect functional performance
15875140|NCT03842202|Drug|Semaglutide|Participants will receive gradually increasing doses of semaglutide (subcutaneous [s.c.], in the thigh, abdomen or upper arm) injection once weekly, until they reach a dose of level of 2.4 mg, which they will continue for 5 weeks.
15875141|NCT03842202|Drug|Placebo|Participants will receive once weekly injections of semaglutide matched placebo.
15875143|NCT03842176|Procedure|Neoadjuvant chemotherapy before surgery|The operable breast cancer patients takes neoadjuvant chemotherapy before surgery.
15875144|NCT03842176|Procedure|Surgery followed by adjuvant chemotherapy|The operable breast cancer patients takes surgery followed by adjuvant chemotherapy.
15875145|NCT03842163|Diagnostic Test|Diagnosis of TTR amyloidosis cardiomyopathy|Diagnosis of TTR amyloidosis cardiomyopathy with scintigraphy
15875146|NCT03842150|Diagnostic Test|biliary atresia screen score|The investigators aim to develop a scoring system according to clinical, laboratory, imaging features of biliary atresia in the derivation dataset and tested in the validation datasets.
15875147|NCT03842137|Device|tDCS|Each participant will undergo 5 consecutive (i.e., business days) sessions of active tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
15875148|NCT03842137|Device|sham tDCS|Each participant will undergo 5 consecutive (i.e., business days) sessions of sham tDCS delivered to the DLPFC. During each session, participants are engaging in tasks that activate the cognitive control network.
15875149|NCT03842124|Other|Force gauge|The investigators postulate that use of bidirectional traction (superior and inferior directions) and feedback from a digital force gauge is associated with minimal lead displacement compared to conventional lead extraction.
15875150|NCT03842085|Drug|Recombinant Humanized Bispecific Monoclonal Antibody MBS301|The patients confirming to the eligibility criteria will be assigned to the 5 dose groups (2mg/kg, 6mg/kg, 10mg/kg,15mg/kg, and 20 mg/kg, respectively) based on the sequence of inclusion. MBS301 will be administered intravenousely on day 1 of each 21-day cycle for each patient.The first intravenous infusion for each patientwill be last for 90 minutes.It could be changed to 60 minutes for the subsequent infusions if the drug is well tolerated.
15875151|NCT03842072|Device|Cervical collar|cervical collars prescribed will be use immediately following anterior cervical discectomy and fusion surgery.
15875152|NCT03842059|Device|Computer-aided detection|We developed an artificial intelligent computer system with a deep neural network (PX-1) to analyze real-time video signals from the endoscopy station
15875153|NCT03842059|Device|Standard colonoscopy|Standard colonoscopy
15875154|NCT03842046|Procedure|phenylephrine infusion|In parturients allocated to the phenylephrine group, a phenylephrine infusion will be initiated as soon as spinal anesthesia is established
15875155|NCT03842046|Procedure|norepinephrine infusion|In parturients allocated to the norepinephrine group group, a phenylephrine infusion will be initiated as soon as spinal anesthesia is established
15875156|NCT03842033|Behavioral|PEAKmAAP|"The PEAKmAAP group will use a mobile app that will help manage asthma."
15875157|NCT03842033|Behavioral|PEAKmAAP-DS|This group will use the mobile app to help manage asthma. the primary care provider will receive monthly reports to help him/her know how the participants asthma symptoms are over time.
15875158|NCT03842033|Behavioral|NutriMap Usual Care|This group will use a non-asthma related app daily to record their daily intake of fruits and vegetables.
15875159|NCT03842020|Other|Blood pharmacokinetic samples|1 or 3 sample(s) will be taken in the following time windows: [H0-H3]; [H5-H9] and just before the next set [H24], depending if the child is or is not admitted to hospital
15875160|NCT03842007|Diagnostic Test|Rectal Barostat Study|Contractions will be recorded with a balloon inserted into the rectum and inflated
15875161|NCT03842007|Diagnostic Test|Fecoflowmetry|Rectum will be filled with a small amount of paste.Two thin catheters will be inserted into the anus to measure pressures and electrical activity (electromyography or EMG). Subjects will be asked to sit on a commode, contract (squeeze) your anal muscles, blow into a balloon, and expel the paste into the commode.
15875380|NCT03840317|Biological|Autologous CD19-targeting CAR T cells|Autologous CD19-targeting CAR T cells
15875162|NCT03841981|Diagnostic Test|Anthropometric and physical examination|"Weight and height.
~Waist-to-hip ratio.
~Body composition: Bioelectrical impedance and [Dual energy X-ray absorptiometry (DEXA)]."
15875163|NCT03841981|Diagnostic Test|Indirect calorimetry, accelerometer and seven-day dietary recall|Energy availability assessment.
15875164|NCT03841981|Diagnostic Test|Biochemical, hormonal and metabolic phenotyping|"Lipid profile.
~Oral glucose tolerance test: plasma glucose and insulin, insulin sensitivity indices, gastrointestinal hormones, adipokines, oxidative stress markers.
~Sex steroid profile.
~Hypothalamic-pituitary-adrenal axis study.
~Ferrokinetic study.
~Subclinical chronic inflammatory markers."
15875165|NCT03841981|Diagnostic Test|Sonographic studies|"Polycystic ovarian morphology.
~Carotid intima-media thickness.
~Eco-FAT: Ultrasound measurements of adipose tissue depots including sc, preperitoneal, intraperitoneal (ip), mesenteric, and perirenal fat thickness."
15875166|NCT03841981|Diagnostic Test|24-hour Ambulatory blood pressure monitoring|A&D TM2430EX oscillometric devices (A&D Company Limited, Tokyo, Japan).
15875167|NCT03841981|Procedure|Percutaneous biopsy|Subcutaneous fat tissue and muscle tissue for proteomics an gene expression studies.
15875168|NCT03841981|Diagnostic Test|Cardiovascular autonomic function studies|Parasympathetic and sympathetic responses to deep breathing, Valsalva's maneuver and orthostatism.
15875169|NCT03841981|Diagnostic Test|Oral smear and feces specimen|Microbiome studies.
15875170|NCT03841968|Procedure|Dynamic needle tip positioning under ultrasound-guidance|The tip of needle is positioned under ultrasound-guidance using dynamic short-axis view.
15875171|NCT03841968|Procedure|Conventional long-axis view|The tip of needle is positioned under ultrasound-guidance using conventional long-axis in-plane view.
15875172|NCT03841955|Device|PICC with high pressure tolerance|Subjects signed informed consent, meet the inclusion criteria and did not meet the exclusion criteria, and were randomly admitted to the experimental group and given the intervention.
15875173|NCT03841955|Device|rontine central venous catheter|Subjects signed informed consent, meet the inclusion criteria and did not meet the exclusion criteria, and were randomly admitted to the control group and given the intervention.
15875174|NCT03841942|Other|clinically-based spacing strategy|All patients (as there are free from symptoms) will have a first step of a 2 weeks spacing of their infliximab infusion interval. Then, at the next infliximab infusion, if clinical remission is maintained (CDAI < 150 for CD, Partial Mayo score < 3 for UC), patients will have a second step of a 2 weeks infliximab infusion spacing which will be maintained until the end of the study.
15875175|NCT03841942|Other|Trough level-based strategy|"patients will have at inclusion a determination of the infliximab trough level. According to this dosage, only patients with a trough level ≥ 7 µg/ml will have a first step of a 2 weeks spacing of their infliximab infusion interval. Then, at the next infliximab infusion, if clinical remission (CDAI < 150 for CD, Partial Mayo score < 3 for UC) is maintained and if infliximab trough level is still ≥ 7 ug/ml, patients will have a second step of 2 weeks infliximab spacing until the end of the study.
~Patients with a baseline infliximab trough level < 7 ug/ml will keep their baseline infliximab infusion interval until the end of the study."
15875176|NCT03841929|Other|Hemodynamic report|The multimodal data comprising the clinical, biochemical, NIRS data and TNE where available will be used by the study team in such cases to reach a description of the hemodynamic status of the study infant and will be provided to the Clinical team.
15875177|NCT03841916|Diagnostic Test|transvaginal ultrasound|transvaginal ultrasound to measure endometrial thickness
15875178|NCT03841903|Diagnostic Test|spinal cord MRI|high-resolution spinal cord MRI sequences on a 3Tesla magnet (Siemens Prisma) with high contrast between SC and CSF as well as high contrast within the SC (grey-white matter contrast)
15875179|NCT03841890|Device|the Clarus Video System as a video stylet|video-guided intubation
15875180|NCT03841890|Device|the Clarus Video System as a lightwand|The endotracheal tube will be initially guided into larynx in the dimly lit operating room by a bright glow moving in the anterior soft tissue of the neck and finally by the image of the trachea rings on the video screen.
15875181|NCT03841890|Device|direct laryngoscope|Macintosh laryngoscope size 3
15875182|NCT03841877|Procedure|endodontic treatment|The operator will remove the pulp inside the tooth, clean, disinfect and shaping the root canals and seal the space with endodontic sealer.
15875183|NCT03841864|Other|IV placement using ultrasound guidance vs traditional method|Ultrasound guided IV placement
15875184|NCT03841851|Procedure|sub epithelial connective tissue graft|"Local anesthesia will be injected intra-orally at the implant site.
~Atraumatic extraction of badley decayed teeth in the aesthetic area traditional drilling for immediate implant placement .
~immediate temporization .
~subepithelial connective tissue graft from the palate"
15875185|NCT03841838|Other|Energy drink|Two 12 oz bottles of commercially available energy drink
15875186|NCT03841838|Other|Placebo drink|Two 12 oz bottles placebo drink. Placebo drink will contain carbonated water, lime juice, and cherry flavoring.
15875187|NCT03841825|Behavioral|Oral hygiene instructions|Oral hygiene instructions and motivation
15875188|NCT03841812|Drug|5mg/kg/h Propofol|5mg/kg/h Propofol continuously infused during intre-operation
15875189|NCT03841812|Drug|Sevoflurane|1% Sevoflurane continuously using during intre-operation.
15875190|NCT03841812|Drug|2 mg/kg/h Propofol|2mg/kg/h Propofol continuously infused during intre-operation
15875191|NCT03841786|Other|Phosphorus-supplemented study diet|Participants will be instructed to consume a normal diet and will take a total of 1,000 mg of supplemental phosphorus per day in the form of neutral sodium phosphorus (K-Phos neutral®) for 1 week.
15875192|NCT03841786|Other|Control Diet|Participants will be asked to consume a normal diet supplemented with sodium and potassium chloride tablets commensurate with the extra sodium and potassium content consumed during the study diet period for 1 week
15875193|NCT03841773|Drug|TNX-102 SL|Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
15875194|NCT03841773|Drug|Placebo SL Tablets|Patients will take 2 tablets of randomly assigned study drug sublingually starting on Day 1 for 12 weeks
15875219|NCT03841591|Drug|Metformin|Women with GDM will receive metformin and tailored according to their blood glucose levels to achieve glycemic control. They will receive an initial metformin dose of 500 mg once or twice daily (according to initial blood glucose level) with food and increased 500 mg every one or two weeks toward targets or up to a maximum daily dose of 2500 mg divided doses with each meal.
15875195|NCT03841760|Diagnostic Test|PSMA PET/CT|"For 18F-DCFPyL PET/CT: Approximately 9 mCi (333MBq) of 18F-DCFPyL is injected intravenously. Approximately 60-90 minutes following 18F-DCFPyL injection, CT and PET images are consecutively acquired from the base of the skull to the toes.
~For 68Ga-PSMA-11 PET/CT: Approximately 2.5 MBq/kg (0.068 mCi/kg) of 68Ga-PSMA, up to a maximum of 300 MBq (8 mCi), is injected intravenously. Approximately 60 minutes following 68Ga-PSMA injection, CT and PET images are consecutively acquired from the base of the skull to toes."
15875196|NCT03841747|Drug|Pembrolizumab|200 mg Pembrolizumab intravenously (IV) every 3 weeks (Q3W).
15875197|NCT03841747|Drug|Paclitaxel|80 mg/m2 paclitaxel intravenously (IV) on Days 1,8, and 15 of each 28 day cycle.
15875198|NCT03841734|Drug|treatment|8 patients will be treat with bosentan at 145 mg per day during 14 days
15875199|NCT03841721|Drug|Linezolid oral tablet 300 mg/day for 5 day|Linezolid oral tablet 300 mg/day for 5 day and blood sample were obtained by direct venipuncture at 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24 hour after drug administration in day 5
15875200|NCT03841708|Device|Pleth variability index|The utility of a early goal directed therapy will be evaluate by the pleth variability index (PVI). If above>13% in a well sedated patients perfectly synchronized with the ventilator providing at least 6ml/kg of ideal body weight, a fluid challeng with 10ml/kg of NaCl 0,9% will be administrated. Patient will be constantly re-assessed until the hemodynamic goals of a mean arterial pressure above 65 mmHg, a capillary refill time below 3 seconds, a decreasing trend on lactates and a urinary output above 0.5/ml/kg/h will be achieved. The second fluid challenge will always be performed with 100 ml of albumin 20%. The third fluid challenge if necessary will be performed with 10 ml/kg of NaCl 0.9%.
15875201|NCT03841708|Device|Standard non invasive monitoring|In the control group patients will be hemodynamically resuscitated in the early phases after ROSC based on standard non invasive monitoring such as SatO2, EtCO2, non invasive blood pressure and continuous ECG. If deemed necessary by the treating physician a fluid challenge of 10ml/kg of NaCl 0,9% will be administrated. Patient will be constantly re-assessed until the hemodynamic goals of a mean arterial pressure above 65 mmHg, a capillary refill time below 3 seconds, a decreasing trend on lactates and a urinary output above 0.5/ml/kg/h will be achieved. The second fluid challenge will always be performed with 100 ml of albumin 20%. The third fluid challenge if necessary will be performed with 10 ml/kg of NaCl 0.9%.
15875202|NCT03841695|Device|RMTC finger-hand robot (Mirror Hand)|The robotic hand will apply on the patient's affected hand and the sensor glove will apply on the patient's un-affected hand, the patient can manipulate their affected hand by their un-affected hand and do the task oriented bimanual training.
15875203|NCT03841695|Other|Conventional OT|The focus of occupational therapy is to help individuals achieve health, well-being, and participation in life through engagement in activities (American Occupational Therapy Association [AOTA], 2014). For stroke rehabilitation, occupational therapy includes retraining in self-care skills, addressing ongoing deficits such as weakness, sensory loss, and cognitive impairments that limit engagement in activities of daily living, and training in community reintegration and modifying tasks or environments.
15875207|NCT03841656|Procedure|PARORISKIMPLANT|Patients attending periodontal and implant treatment at the Department of Periodontology of the Dental Faculty at Strasbourg, France, between 2000-2015.
15875208|NCT03841643|Device|patient-specific implant|solid titanium implant that functions as a guiding template for harvesting, and as an implant for reconstruction of the cranial defect
15875209|NCT03841643|Device|cement|norian cement for reconstruction of the cranial defect
15875210|NCT03841630|Drug|LY3437943|Administered subcutaneously (SC)
15875211|NCT03841630|Drug|Placebo|Administered SC
15875212|NCT03841617|Drug|Thyrogen|intramuscular injection administered once/day for 2 consecutive days at Week 3; then once annually for subjects who meet criteria.
15875213|NCT03841617|Radiation|I-131|therapeutic dose administered orally to treat thyroid cancer at Week 8. 5-7 days later, the post-treatment I-131 Whole Body scan w/SPECT is performed; then administered once annually, if the patient needs to be re-treated.
15875214|NCT03841617|Radiation|I-124|one capsule ingested orally once at Week 3, and Week 8; then administered once annually to subjects who meet criteria.
15875215|NCT03841617|Other|Thyroid hormone withdrawal|withdrawal of thyroid hormone during weeks 4 through 8
15875216|NCT03841604|Drug|Safinamide Methanesulfonate|50 mg, 100 mg
15875217|NCT03841604|Drug|Safinamide methanesulfonate matching placebo|50 mg, 100 mg
15875218|NCT03841591|Drug|Insulin|Women with GDM will receive insulin and tailored according to their blood glucose levels to achieve glycemic control. Starting dose will be 30unit (20 unit intermediate dose + 10 unit rapid acting insulin) in the morning and before breakfast). In the 2nd trimester, we will start with half of the previous dose and if post dinner glucose level remain elevated additional injection of rapid acting insulin will be given just prior to dinner. If fasting glucose is elevated, intermediate acting insulin can be given along with the dinner dose of rapid acting insulin.
15875220|NCT03841591|Other|Assessment of weight gain|Body weight will be measured monthly from the start of treatment till delivery.
15875221|NCT03841578|Dietary Supplement|Healthy|25g of dark chocolate (70%) will be provided to participants on Phase 1 (organoleptic assessment). On Phase 2 (gastrointestinal motility assessment), they will ingest a standard liquid meal (NutriDrink, 200ml), consisting of 10g of lactulose and 12g of fat
15875222|NCT03841565|Biological|Daratumumab|Given IV
15875223|NCT03841565|Drug|Dexamethasone|Given PO
15875224|NCT03841565|Drug|Pomalidomide|Given PO
15875225|NCT03841552|Device|Augmented Feedback|An inertial measurement unit (IMU) system is the basis of the augmented feedback (AF) system, where the IMU-system communicates with a laptop using a bluetooth dongle. The corresponding software includes therapeutic games. Movements of the lower back and pelvis by the patient are used to control an avatars movement or the graphical interface in computer exercises. The AF-system provides real-time feedback regarding the patient's performance and helps to rectify incorrect execution of the exercises. The intervention took place at a physiotherapy clinic and in an home environment. In the physiotherapy clinic the patients exercised under the supervision of the physiotherapists. They continued the exercises at home as home exercises.
15875226|NCT03841552|Other|Control Group|Conventional impairment-specific physiotherapy exercises for low back pain patients.The control intervention took place at a physiotherapy clinic and in an home environment. In the physiotherapy clinic the patients exercised under the supervision of the physiotherapists. They continued the exercises at home as home exercises.
15875227|NCT03841539|Behavioral|Mediterranean Diet|Diet consisting of fruits, vegetables, whole grains, low-fat dairy, olive oil, seafood, nuts and beans. It is low in red and processed meats, solid fats and added sugars.
15875228|NCT03841539|Dietary Supplement|Study Supplement|Randomized to take a daily dose of either 2 grams of Omega 3 fatty acids or 2 grams of a Placebo.
15875229|NCT03841539|Behavioral|Low-fat Diet|Diet consisting of fruits, vegetables, whole grains, low-fat dairy, and low-fat protein, with fat contributing no more than 25% of calories.
15875230|NCT03841526|Drug|Glucagon RTU Injection|0.15 mg injection
15875231|NCT03841526|Other|Vehicle for Glucagon RTU Injection|0.15 mg injection
15875232|NCT03841513|Procedure|Laparoscopic Burch Colposuspension|The Burch Colposuspension is an anti-incontinence procedure where non-absorbable monofilament suture is used in the retropubic space to form a suture bridge between the anterior vagina and Cooper's ligament, thereby gently elevating the anterior vaginal wall and providing urethral support.
15875233|NCT03841500|Device|Biocomposite intereference screw femoral tunnel fixation|ACL reconstruction using biocomposite intereference screw for femoral tunnel fixation
15875234|NCT03841500|Device|Endobutton (Tightrope) femoral tunnel fixation|ACL reconstruction using endobutton (Tightrope) for femoral tunnel fixation
15875235|NCT03841487|Device|Aspiration thrombectomy|In the aspiration thrombectomy group, aspiration thrombectomy was performed for patients with ST elevation myocardial infarction who underwent primary percutaneous coronary intervention (PCI). In the PCI alone group, the STEMI patient received conventional primary PCI without aspiration thrombectomy during the procedure.
15875236|NCT03841474|Drug|Psychiatric treatment with sertraline|Psychiatric treatment with sertraline (range from 50 mg/day to 200mg/day according to clinical appearance) of newly recognized depression in patients after PCI
15875237|NCT03841474|Drug|Psychiatric treatment with escitalopram|Psychiatric treatment with escitalopram (range from 10 mg/day to 20 mg/day according to clinical appearance) of newly recognized depression in patients after PCI
15875238|NCT03841461|Other|International Physical Activity Questionnaire-Short Form|IPAQ has been developed to obtain valid and comparable information about the level of physical activity based on individual reports on daily physical activity in the international arena. This form consists of 7 questions; provides information about time spent in walking, moderate and violent activities, and time spent sitting. The calculation of the total score of the short form includes total of duration and frequency whom walking, moderate activity and severe activity. The energy required for the activities is calculated by the MET-minute score.Standard MET values for these activities has been established. These; Walking = 3.3 MET;Moderate Severe Physical Activity = 4.0 MET;Severe Physical Activity = 8.0 MET;Seating = 1.5 MET.Classification is based on the numerical data obtained.Accordingly,there are 3 activity levels: Inactive,minimal active and very active.
15875239|NCT03841461|Other|The Pittsburgh Sleep Quality Index|It is a scale that provides information about the sleep quality of the individuals and the type and severity of the sleep disorder in the last month. It consists of 24 questions, 19 of which are evaluated. The PSQI consists of 1 total score and 7 sub-dimensions (subjective sleep quality, sleep latency, sleep duration, usual sleep efficiency, sleep disturbance, sleep medication use, daytime dysfunction). Each item in the scale has a value between 0 (no distress) and 3 (serious distress). The sum of the scores related to the seven sub-dimensions gives the total PSQI score. The score of each sub-dimension ranges from 0 to 3. The total PSQI score ranged from 0 to 21. While the sleep quality of the patients with a total score of 5 and below is considered as 'good'; >5 refers to poor sleep quality.
15875240|NCT03841461|Other|The Fatigue Severity Scale|Each question on this scale, which is composed of Likert type questions: 1.I strongly disagree 2.I do not agree 3.No tend to disagree 4. Indefinitely. The score of the scale, which consists of 9 questions, varies between 9-63. People are asked to mark the appropriate options for each question taking into account their status in the last 1 month period.
15875241|NCT03841461|Other|General Information Form|A form, which is prepared by us, including the purpose of the study, demographic information, daily working hours and assignment durations.
15875244|NCT03841435|Radiation|Hypofractionated Radiotherapy|Radiotherapy Treatment, totaling 15 Gy, will be given in 3 fractions over 2 weeks.
15875245|NCT03841422|Procedure|video-assisted nasal self-packing|video-assisted nasal self-packing
15875246|NCT03841409|Other|Collection of blood samples|Nine blood samples will be collected to determine bupivacaine pharmacokinetics at T10min, T20min, T30min, T45min, T60min, T90min, T120min, T180min, and T240min. T0 will be defined as the end of bupivacaine injection.
15875247|NCT03841396|Drug|Sodium chloride|All participants received a single dose of sodium chloride as placebo
15875248|NCT03841383|Diagnostic Test|Echo stress dipyridamole|Echo stress dipyridamole
15875289|NCT03841006|Device|MRI|dynamic MRI pelvis
15875290|NCT03840993|Drug|MT-2990|IV
15875249|NCT03841370|Procedure|endodontic treatment|Color measurements of endodontically treated teeth (incisors, canines or premolar) will be collected regardless of technique, treatment time and sealer used.
15875250|NCT03841357|Drug|Abatacept Injection|Supplied as a weekly injection via a pre-filled syringe
15875251|NCT03841357|Other|Usual Care|Usual care will be defined by the clinical management team but includes steroid joint injections and non-steroidal anti-inflammatory drugs
15875252|NCT03841344|Device|MRI|Evaluation of the utility of candidate endpoints in PAH trials
15875253|NCT03841331|Drug|5 mg Serlopitant Tablets|Serlopitant Tablets
15875254|NCT03841331|Drug|Matching Placebo Tablets|Placebo Tablets
15875255|NCT03841318|Biological|blood sample|36 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
15875256|NCT03841318|Biological|biopsy of the labial salivary gland|Part of the biopsy of the labial salivary gland
15875257|NCT03841305|Procedure|Liver preparation before major hepatectomy|Simultaneous portal and hepatic vein embolization versus Portal vein embolization, also called venous deprivation OR portal vein embolization.
15875258|NCT03841292|Drug|Varenicline|Varenicline (Champix®), Pfizer Canada Inc., Kirkland, Quebec. Dispense for 12 weeks. One tablet (0.5mg) once daily for first three days, then one tablet (0.5 mg) twice daily for next four days, then 1 mg (one 1mg tablet) twice daily for the remainder of 12 weeks. Dose adjustments due to adverse events will be allowed (i.e. decrease to 0.5 mg twice daily).
15875259|NCT03841292|Device|Active tDCS|Active 2mA tDCS (Nuraleve, Canada) with the anode placed over the left dorsolateral prefrontal cortex (dlPFC) and the cathode placed over the right dlPFC for 20 minutes per session
15875260|NCT03841292|Device|Sham tDCS|Shame tDCS (Nuraleve, Canada) (30 seconds of 2mA and 19.5 minutes of 0 mA) with the anode placed over the left dorsolateral prefrontal cortex (dlPFC) and the cathode placed over the right dlPFC for 20 minutes per session.
15875261|NCT03841279|Diagnostic Test|MRI|Magnetic resonance imaging (MRI) produces detailed images of the body's internal structures without relying on radiation. It is used to diagnose and also gauge efficacy of treatment.
15875262|NCT03841266|Diagnostic Test|recurrence risk evaluation|Recurrence score were obtained by 21-gene detection kits from different biological companies. The expression of ER, PR, and Her-2 were also detected by IHC.
15875263|NCT03841253|Procedure|Trans-epithelial PTK|The MEL 90 excimer laser will be used to ablate the corneal epithelium and stroma to a pre-defined depth, using the epithelium as a natural masking agent to smooth the stromal surface.
15875264|NCT03841253|Device|EpiMaster Application Software|The EpiMaster Application Software imports epithelial thickness data and corneal front surface topography data, and uses this to calculate the refractive change that would be induced by a trans-epithelial PTK treatment.
15875265|NCT03841227|Device|Active-tDCS|Active home-based tDCS applied at home. 5 days a week for 4 weeks.
15875266|NCT03841227|Device|Sham-tDCS|Sham home-based tDCS applied at home. 5 days a week for 4 weeks.
15875267|NCT03841201|Drug|Lenvatinib|oral
15875268|NCT03841201|Drug|Nivolumab|iv infusion
15875269|NCT03841188|Other|Nutritional orientation|Nutritional orientation with emphasis in rich calcium food
15875270|NCT03841149|Other|Ultrasound Imaging|3D volume calculation using on-line and off-line softwares
15875271|NCT03841136|Drug|anlotinib|anlotinib 12mg PO QD CBP(AUC 5mg/mL/min，or DDP（75mg/m2）D1 etoposide（100mg/m2）D1~D3
15875272|NCT03841123|Other|Dietary Counseling|"The intervention will consist of an individualized, face-to-face, 20 to 30 minute counseling session to mothers by trained health workers who will address healthy eating practices during the first two years of life. A printed, colorful and illustrated material will be used to assist mothers in appropriate food choices, mainly to avoid the introduction of sugar and ultra-processed foods. In addition, they will receive a booklet which addresses the Ten Steps of Healthy Feeding for children from Birth to Two years of life. The research team will focus on Step2: Do not give added sugar or foods with added sugar, and Step8:Do not offer ultra-processed foods as candies and soft drinks. To reinforce the intervention, mothers will receive telephone calls up to the infant reach six months."
15875280|NCT03841097|Drug|Extended Release Tacrolimus Tablets|The primary objective is to assess the change in pulse wave velocity (PWV) and vascular compliance measurements from baseline to 12 months after transplant in kidney recipient subjects on LCPT compared to those on IR-Tac.
15875281|NCT03841097|Drug|Immediate Release Tacrolimus Capsule|The primary objective is to assess the change in pulse wave velocity (PWV) and vascular compliance measurements from baseline to 12 months after transplant in kidney recipient subjects on LCPT compared to those on IR-Tac.
15875282|NCT03841084|Drug|Oxygen|"Conservative oxygen management strategy- reduces oxygen on the inoblender in the ECMO circuit.
~Liberal oxygen management strategy - does not reduce the oxygen on the inoblender via the ECMO circuit"
15875283|NCT03841071|Other|ROM/CFS intervention|The intervention (ROM/CFS) includes self-reported measures for adaptation to life with an ostomy and health-related quality of life, as well as patient satisfaction recorded by the clinical feedback system. The measures are electronically assessed before each clinical consultation at 3, 6, and 12 months after surgery, and annually thereafter. The scores are instantly analysed and graphically presented for use during the consultation and the patient and stoma care nurse can discuss the findings.
15875284|NCT03841058|Drug|Abaloparatide|80 mcg delivered SC by a pen
15875285|NCT03841058|Drug|Placebo|A pen to deliver a SC dose of placebo
15875286|NCT03841032|Drug|Coppertone, BAY1183345|Lotion, for 4 weeks
15875287|NCT03841019|Device|Magpro X100 + Option|In addition to treatment as usual (TAU), participants were supposed to receive twelve sessions of MST in four weeks (three sessions per week)
15875288|NCT03841019|Device|ThymatronSystem Ⅳ Electroconvulsive System|In addition to treatment as usual (TAU), participants were supposed to receive twelve sessions of ECT in four weeks (three sessions per week)
15875293|NCT03840954|Other|Neuromuscular Electrical Stimulation|"The application of NMES will be performed with the patient positioned in the supine position in the bed. Self-adhesive electrodes will be positioned at the motor points of the quadriceps and anterior tibial muscles respectively. A symmetrical biphasic pulsed current with a frequency of 80 Hz, a pulse width of 500 μs and an intensity at the motor threshold will be applied up to the maximum tolerated by the patient. ON and OFF time and total session time will be used according to protocol with progressive increase of the total intervention time and reduction of OFF time of the NMES. The device used will be the Neurodyn II model, manufactured by IBRAMED.
~Patients will receive NMES for as long as they remain hospitalized or for up to 3 weeks."
15875294|NCT03840915|Drug|Cisplatin|Cisplatin will be administered intravenously at a dose of 75 milligrams per meter square (mg/m^2) over 60 minutes every 21 days for 4 cycles (each cycle is 21 days).
15875295|NCT03840915|Drug|Carboplatin|Carboplatin will be administered at area under the concentration-time Curve (AUC) 5 when combined with pemetrexed over 30 to 60 minutes every 21 days for 4 cycles (each cycle is 21 days).
15875296|NCT03840915|Drug|Pemetrexed|Pemetrexed will be administered intravenously at a dose of 500 mg/ m^2 over 10 minutes every 21 days.
15875297|NCT03840915|Drug|Nab-paclitaxel|Nab-paclitaxel will be administered intravenously at as dose of 100 mg/m^2 over 30 minutes in a 21 days cycle on Day 1, 8, and 15 in each cycle for 4 cycles (each cycle is 21 days).
15875298|NCT03840915|Drug|Gemcitabine|Gemcitabine will be administered intravenously at a dose of 1250 mg/m^2 over 30 minutes in a 21 days cycle on Day 1, and 8, in each cycle for 4 cycles (each cycle is 21 days).
15875299|NCT03840915|Drug|Docetaxel|Docetaxel will be administered intravenously at a dose of 75 mg/m^2 over 60 minutes every 21 days for 4 cycles (each cycle is 21 days).
15875300|NCT03840915|Drug|M7824|M7824 will be administered intravenously at a dose of 2400 mg every 21 days in combination with chemotherapy for 4 cycles (each cycle is 21 days) followed by up to 31 cycles in maintenance with M7824 and pemetrexed.
15875301|NCT03840915|Drug|Carboplatin|Carboplatin will be administered at area under the concentration-time Curve (AUC) 6 when combined with nab-paclitaxel over 30 to 60 minutes every 21 days for 4 cycles (each cycle is 21 days).
15875302|NCT03840915|Drug|Carboplatin|Carboplatin will be administered at area under the concentration-time Curve (AUC) 5 when combined with gemcitabine over 30 to 60 minutes every 21 days for 4 cycles (each cycle is 21 days).
15875303|NCT03840915|Drug|M7824|M7824 will be administered intravenously at a dose of 2400 mg every 21 days in combination with chemotherapy for 4 cycles (each cycle is 21 days) followed by up to 31 cycles in maintenance with M7824 alone.
15875304|NCT03840915|Drug|Paclitaxel|Paclitaxel will be administered intravenously at a dose of 200 mg/m2 over 3 hours every 3 weeks for 4 cycles (each cycle is 21 days).
15875305|NCT03840902|Drug|M7824|Participants will receive intravenous infusion of 1200 milligram (mg) M7824 over 1 hour every 2 weeks (q2w) during cCRT and up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
15875306|NCT03840902|Drug|Placebo|Participants will receive intravenous infusion of placebo matched to M7824 over 1 hour q2w during cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
15875307|NCT03840902|Drug|Durvalumab|Participants will receive intravenous infusion of durvalumab 10 milligram per kilogram (mg/Kg) over 1 hour q2w up to 1 year after cCRT until unacceptable toxicity, confirmed disease progression assessed by investigator.
15875308|NCT03840902|Drug|Etoposide|Participants will receive etoposide 50 mg/m^2 intravenously over a minimum of 30 minutes up to 60 minutes daily on Day 1 to 5 and Day 29 to 33 during cCRT.
15875309|NCT03840902|Drug|Pemetrexed|Participants will receive pemetrexed at a dose of 500 mg/m^2 intravenously over 10 minutes or according to local standards on Days 1, 22, and 43 during cCRT.
15875310|NCT03840902|Drug|Carboplatin|Participants will receive carboplatin intravenously based on area under curve (AUC) 2 over 30 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT.
15875311|NCT03840902|Drug|Paclitaxel|Participants will receive paclitaxel intravenously at a dose of 45 mg/m^2 over 60 minutes on Day 1, Day 8, Day 15, Day 22, Day 29, Day 36, and Day 43 during cCRT.
15875312|NCT03840902|Drug|Cisplatin|In combination with etoposide, participants will receive cisplatin 50 mg/m^2 intravenously over 60 minutes on Days 1, 8, 29, and 36 during cCRT. In combination with pemetrexed, participants will receive cisplatin 75 mg/m2 intravenously over 60 minutes on Days 1, 22, and 43 during cCRT.
15875313|NCT03840902|Radiation|Intensity Modulated Radiation Therapy (IMRT)|Participants will receive IMRT 5 fractions per week for about 6 weeks (Total 60 gray [Gy]).
15875314|NCT03840889|Other|Data collection|"he different modes of active data collection:
~Data collection by telephone
~Data collection by mail
~Collection from discharge database summaries (PMSI)"
15875315|NCT03840876|Device|WEI NASAL JET (WNJ)|Jet ventilation was achieved with WEI NASAL JET (WNJ) connected to a manual jet ventilator (Driving pressure: 40 psi, fraction of inspired oxygen: 100% O2, Respiratory rate: 25/min, I/E ratio: 40%)
15875316|NCT03840863|Dietary Supplement|Commercially-Available Energy Drink|Participant will consume 2 cans of an energy drink (16 oz./can) per day. One in the morning and one in the afternoon.
15875317|NCT03840850|Other|Personalized Risk Communication for People with Type 2 Diabetes|The risk communication intervention consists of communicating the impact of being poorly controlled on two types of outcome: (1) absolute 10-year risk of experiencing a cardiovascular event, i.e. heart attack or stroke (10-year CV risk); (2) life expectancy. These personalized risk estimates are calculated based on the UKPDS outcomes model (version 2), which is a prognostic model of reference in the area of Type 2 diabetes.
15875319|NCT03840811|Drug|Cefixime|Mandatory rescue therapy consisting of cefixime 400 mg orally in a single dose: on patient request, at the onset of symptoms or on the 5th study day after inoculation.
15875320|NCT03840811|Drug|Ceftriaxone|Mandatory rescue therapy consisting of ceftriaxone 250 mg intramuscularly in a single dose: on patient request, at the onset of symptoms or on the 5th study day after inoculation.
15875321|NCT03840811|Drug|Ciprofloxacin|Mandatory antibiotic treatment failure therapy: Ciprofloxacin 500 mg orally in a single dose: if the subject has a positie test of cure 1 week post initial antibiotic treatment
15875322|NCT03840811|Biological|Neisseria gonorrhoeae strain FA1090 A26|0.4 mL of a suspension containing 10^5 - 10^6 CFU of Neisseria gonorrhoeae, in phosphate-buffered saline, delivered to the anterior urethra through a No.8 pediatric French catheter.
15875323|NCT03840811|Biological|Neisseria gonorrhoeae strain FA7537|0.4 mL of a suspension containing 10^5 - 10^6 CFU of Neisseria gonorrhoeae, in phosphate-buffered saline, delivered to the anterior urethra through a No.8 pediatric French catheter
15875324|NCT03840798|Other|Child Abuse Clinical Decision Support system|"The investigators are implementing the following aspects of the Electronic Health Record (EHR) based child abuse- clinical decision support (CA-CDS) system.
~a universal child abuse screen (CAS)
~an embedded child abuse alert system
~alerts to physicians and advanced practice providers
~physical abuse order sets"
15875325|NCT03840785|Other|Argentine tango|"Argentine tango sessions will consist of:
~Body perception and body control: sitting, standing then moving around four axes : space, time, energy, gravity.
~Awareness of oneself, of other and music: listening, communication, touch, empathy, kinesthesia, letting go, feeling"
15875326|NCT03840772|Drug|Eribulin|Treatment with eribulin
15875327|NCT03840759|Other|inpatient geriatric consultation team|For the intervention group, a geriatric physician was consulted and recommendations were made by the geriatric consultant after a complete CGA.
15875328|NCT03840746|Other|Tomato, onion and lovage soup (TOL)|Soup
15875329|NCT03840746|Other|TOL soup with inulin|Soup
15875330|NCT03840707|Behavioral|LIFEwithIBD|"LIFEwithIBD programme is a psychotherapeutic programme based on Acceptance, Mindfulness and Compassion for inflammatory bowel disease patients
~Treatment as Usual (TAU): Standard personalized treatment of inflammatory bowel disease"
15875331|NCT03840694|Other|Smoking Abstinence|Participants will abstain from smoking for 24 hours.
15875332|NCT03840694|Other|Ad Lib Smoking|Participants will continue smoking as usual (i.e. ad lib) and smoke one cigarette of their own brand immediately prior to scanning.
15875333|NCT03840681|Other|Augmentation|non invasive technique to increase bone width and eliminate need for second surgery
15875334|NCT03840668|Device|USB Eye Mask|To evaluate the acceptance of the USB eye mask via questionnaire and also to monitor the use of USB eye mask over a period of 3 months.
15875335|NCT03840655|Procedure|Near-Infrared Imaging Thoracoscopy|Sympathicotomy performed by near-infrared imaging thoracoscopy
15875336|NCT03840642|Behavioral|Mirror Me|Mirror Me is a telehealth parent training intervention that teaches parents to promote their child's social imitation during play and daily routines. It uses content from Reciprocal Imitation Training (RIT), an evidence-based NDBI that teaches social imitation within affect-laden playful interactions. Mirror Me presents intervention content in four interactive modules. Program development was guided by the technology acceptance model, media richness theory, and principles of instructional design.
15875337|NCT03840642|Behavioral|Remote Coaching|Trained therapists will provide feedback to parents as they use the RIT techniques with their child at home. All sessions will follow a similar format including a discussion of accomplishments and challenges, parent practice with feedback, problem solving, and planning for the next week
15875338|NCT03840629|Other|No study intervention.|
15875339|NCT03840616|Drug|VT-1161 150 mg capsule|During Part 1, administered orally once daily for 2 days. During Part 2, administered orally once weekly for 11 weeks starting on Day 14.
15875340|NCT03840616|Drug|Fluconazole 150 mg|During Part 1, administered orally 3 sequential doses (every 72 hours).
15875341|NCT03840616|Other|Placebo|During Part 2, administered orally once weekly for 11 weeks starting on Day 14.
15875342|NCT03840603|Diagnostic Test|Film Array RP2 Assay guided|Nasopharyngeal swab sample collected from subjects with a suspected LRTI for the Film Array RP2 assay plus a blood sample for the PCT assay.
15875343|NCT03840590|Device|CSK AI system|CSK system is equipped with the endoscopic mainframe and alarms the examiners when suspect lesions appear.
15875344|NCT03840590|Device|Standard Colonoscopy|This is the routine examination in nowadays clinical practice. Both the equipment and the procedure are as usual as clinical routine.
15875345|NCT03840577|Device|Monitorization of sedation by Bispectral Index|"The BIS value of the patient will be evaluated twice per nursing shift (every 4 hours) and will be recorded in the electronic medical record. The objective of BIS will be between 40 and 60.
~According to the BIS of the patient at the time of the evaluation, the dose of sedative administered in a continuous infusion pump will be increased or reduced in order to reach the target BIS, with 20% modifications of the current dose at the time of evaluation.
~The dose of sedative used will be recorded in the electronic medical record. The BIS values will be saved in the equipment and downloaded every 72 hours."
15875346|NCT03840577|Other|Monitorization of sedation by clinical scales|"The BIS monitor will be placed on the patient but it will be left blind to the nursing team, the BIS values will be stored in the equipment and downloaded every 72 hours.
~The RASS of the patient will be evaluated twice per nursing shift (every 4 hours) and will be recorded in the electronic medical record. The RASS will be evaluated by a research team member.
~According to the patient's RASS at the time of evaluation, the dose of sedative administered in a continuous infusion pump will be increased or reduced in order to reach the target RASS. The modification of infusion speed will be done by the nurse in charge of the patient. The dose of sedative applied will be recorded in the electronic medical record."
15875347|NCT03840564|Other|Point of care (POC)|All the analyzes will be done in delocalized
15875348|NCT03840551|Other|Biomechanical analysis with inertial sensors (XSENS) and motion capture (BTS)|The kinematics of lower limbs, trunk and upper limbs will be calculated both with inertial sensors (XSENS) and motion capture marker-based system (BTS ). Inertial sensors and markers will be placed on the subjects clothes and on the skin (totally non-invasive) to identify body segments. Then subjects will perform their motor tasks normally. Lately, through the data post-processing, the kinematics evaluated with both the systems will be used to describe how well the task is performed in terms of ACL prevention, through derived biomechanical parameters.
15875349|NCT03840538|Drug|Probiotic Product - Cap|probiotic capsule complex composed of L.acidophilus, L. bulgaricus, Streptococcus thermophilus, and Bifidobacterium bifidus
15875350|NCT03840525|Behavioral|The Qigong Intervention|Qigong is a low-impact, slow-movement, meditative form of exercise that has helped relieve mental and physical stressors.
15875351|NCT03840525|Behavioral|Sham Qigong|This intervention includes similar body movements to qigong; however, it does not have the meditative or breath work.
15888863|NCT03736616|Drug|Etoposide|Chemotherapy
15875352|NCT03840512|Drug|CBD|"CBD + Standard aGVHD prophylaxis calcineurin inhibitor (cyclosporine or tacrolimus) + methotrexate (MTX).
~Subjects transplanted from unrelated donors or from mismatched siblings will also receive anti-T cell globulin."
15875353|NCT03840499|Drug|Optimal medical therapy|Optimal medical therapy
15875354|NCT03840486|Device|Non-rebreather mask (NRBM)|The non-rebreather mask (NRBM) will be used to assist in the delivery of oxygen. Participants will be placed on NRBM at different flow rates (15 LPM (Liter per minute), 35 LPM, or Flush rate at 55 LPM).
15875355|NCT03840486|Device|Non-invasive ventilator mask (NIV)|The NIV is a non-invasive face (nasal) mask for oxygen delivery. Participants will receive oxygen at 50% FiO2 for 3 minutes, 75% FiO2 for 3 minutes or 100% FiO2 for 3 minutes each.
15875356|NCT03840486|Device|Nasal cannula EtO2 sensor|The nasal cannula EtO2 sensor will be placed on the participant's face under the mask to detect the EtO2 levels.
15875357|NCT03840486|Drug|Oxygen (NRBM)|Oxygen will be delivered via the NRBM. Participants will receive oxygen at different flow rates (15 LPM (Liter per minute), 35 LPM, or flush rate at 55 LPM).
15875358|NCT03840486|Drug|Oxygen (NIV)|Oxygen will be delivered via the NIV mask. Participants will receive oxygen at 50% FiO2, 75% FiO2 or 100% FiO2 for 3 minutes each.
15875359|NCT03840473|Behavioral|MET|The patient was in a supine position with the cervical spine in the opposite lateral flexion to the treating part so that the upper trapezius muscle fibers were in a lengthened position.19 The moderate isometric contraction (approximately 75% of maximal) of the upper trapezius muscles was elicited for a period of 5 seconds followed by 3 seconds of relaxation while reaching the new barrier. The technique was repeated four times in each session.
15875360|NCT03840473|Behavioral|ICT|The patient lying in the supine position with the cervical spine in opposite lateral flexion to the treating part so that the upper trapezius muscle fibers were kept in a lengthened position.18,22 The physiotherapist applied gradually increasing pressure to the MTrPs until the subject perceived the first noticeable pain. At that moment, the pressure was maintained until the discomfort and/or pain eased by around 50% as perceived by the patient, at which time the pressure was increased until the discomfort appeared again. This process was maintained for 90 seconds.
15875361|NCT03840473|Behavioral|Conventional Intervention|Hot packs (75°C) for 20 minutes and active stretching exercises for the upper trapezius muscle (slow, 5 repetitions per session, 10-second hold and 10-second relaxation between two repetitions). Active stretching exercises were done by all the participants under the supervision of the physical therapist. This approach was standardized for all participants.
15875362|NCT03840447|Behavioral|Chronic Disease Self-Management programme|"The primary aim of the intervention is to achieve greater self-management of the chronic condition by changing the role of the passive citizen to empowerment in self-confidence and self-reliance. The intervention consists of a series of 6 workshops (with 7 to 8 activities), 2.5 hours each, which are held once a week for 6 weeks. One professional and one peer will volunteer together to lead a series of workshops. To this end, professionals and peers will be recruited and trained in the CDSMP principles.
~Over 6 workshops, citizens set realistic health goals, learn to self-manage pain and discomfort, to self-manage their diet, self-manage physical activity, mood and the way the disease influences their personal relationships. The intervention is designed to actively involve citizens."
15875363|NCT03840434|Diagnostic Test|MyotonPRO|Each patient will perform a stress test to trigger the painful. Measurements will be done by intramuscular punction as usually, and by non invasive tool : MyotonPRO
15875364|NCT03840421|Drug|gemcitabine and cisplatin|Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before concurrent chemoradiotherapy.
15875365|NCT03840421|Drug|cisplatin and fluorouracil|Patients receive fluorouracil (800mg/m2 d1-5) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before concurrent chemoradiotherapy.
15875366|NCT03840421|Radiation|IMRT|Intensity modulated-radiotherapy (IMRT) is given as 30～33 fraction with five daily fractions per week for 6-7 weeks to a total dose of 68～70 Gy to the primary tumor
15875367|NCT03840421|Drug|cisplatin|IMRT concurrently with cisplatin 100 mg/m² every 3 weeks for 2 cycles.
15875368|NCT03840408|Other|Mitochondria-targeted System Therapy Combined With Radiofrequency Ablation|Patients will be treated with mitochondria-targeted system therapy and radiofrequency ablation in the primary tumor sites
15875369|NCT03840408|Procedure|Surgery|Patients will be treated with surgery
15875370|NCT03840395|Device|Pharyngeal Electrical Stimulation (PES)|The Phagenyx® system is a two-part neurostimulation system. It is composed of a durable component called the Base Station and the single-use sterile disposable Catheter. The Base Station acts as the user interface and provides the means to generate, optimize and monitor the delivery of electrical stimulation to the oropharynx. The Phagenyx® devices are CE labelled (2012) and will be used in accordance with their intended use label.
15875371|NCT03840382|Behavioral|Tele-PrEP Intervention|Telemedicine conferences with PrEP-specialists
15875372|NCT03840369|Device|Repetitive Transcranial Magnetic Stimulation to Right Dorsolateral Prefrontal Cortex|Transcranial magnetic stimulation (TMS) works by delivering a magnetic pulse to a focal brain region. TMS has a high degree of safety and has been studied as an intervention for many mental health and neurological conditions. Repetitive TMS (rTMS) delivers pulses at a set time interval in order to modulate neural activity in that region.
15875373|NCT03840369|Device|Sham Repetitive Transcranial Magnetic Stimulation|The sham TMS coil will make a similar sound to the real rTMS coil, but will not deliver a magnetic pulse. This is a no-treatment device.
15875374|NCT03840369|Device|Repetitive Transcranial Magnetic Stimulation to Right Dorsomedial Prefrontal Cortex|Transcranial magnetic stimulation (TMS) works by delivering a magnetic pulse to a focal brain region. TMS has a high degree of safety and has been studied as an intervention for many mental health and neurological conditions. Repetitive TMS (rTMS) delivers pulses at a set time interval in order to modulate neural activity in that region.
15875375|NCT03840356|Other|Postoperative|No intervention is planned in the study. This study is simply evaluating the consistency with which patients report their pain levels to different members of the medical team.
15875376|NCT03840343|Biological|Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Lower Dose|Two MSC infusions of 2.5x10^5 cells/kg at time zero and three months; single kidney, intra-arterial delivery
15875377|NCT03840343|Biological|Autologous adipose-derived mesenchymal stem/stromal cells (MSC) Higher Dose|Two MSC infusions of 5.0x10^5 cells/kg at time zero and three months; single kidney, intra-arterial delivery
15875381|NCT03840304|Other|Yoga@work|Each session included warm-up practices(for the large joints, spine, and extremities), Physical postures (Asana), breathing exercises (pranayama) and supine meditation/relaxation (savasana).
15875382|NCT03840291|Drug|Edoxaban|Edoxaban will be used for resolution of left atrial appendage thrombi
15875383|NCT03840278|Device|Bihormonal iLet Bionic Pancreas|Bihormonal iLet Bionic Pancreas using insulin and dasiglucagon
15875384|NCT03840278|Device|Insulin-only Bionic Pancreas|Insulin-only iLet Bionic Pancreas using just insulin
15875385|NCT03840278|Drug|Dasiglucagon|Experimental stable glucagon for use in the iLet Bionic Pancreas
15875386|NCT03840265|Procedure|carotid endarterectomy|In this project the following parameters will be assessed both in asymptomatic and symptomatic patients underwent carotid endarterectomy: 1) hemodynamic modeling of effect of the supraaortic arteries anatomic variations and pathologies 2, preoperative stroke risk prediction based on comparative analysis of CTA results of plaque morphology and ultrasound-based plaque elastography analysis, 3) cerebral flow measurement by transcranial Doppler sonography(TCD), 4) presence recent of silent brain ischemia on DWI-MRI, 5) OCT angiography could be a useful non-invasive method for evaluation of the outcome of carotid interventions
15875387|NCT03840252|Diagnostic Test|3D gait analysis|Computed analysis of posture and gait pattern and motor performance by kinematic and kinetics parameters analysis such as the step length, gait velocity, stride time variability, 3D joint kinematics, ground reaction forces, joint kinetics
15875388|NCT03840252|Diagnostic Test|rsfMRI|MR scans acquired by 1.5 Tesla (Siemens Medical Systems, Erlangen, Germany).
15875389|NCT03840252|Diagnostic Test|Montreal Cognitive assesment (MoCA)|Standard clinical questionnaire
15875390|NCT03840239|Drug|Capecitabine, Oxaliplatin|Drug: Capecitabine, Oxaliplatin
15875391|NCT03840239|Radiation|External beam radiotherapy|External beam radiotherapy to the primary tumor, regional lymph nodes and clinical target volume
15875392|NCT03840239|Procedure|Surgery|'Local excision' or 'Intersphincter resection' or 'Total mesorectal excision' or other surgeries
15875393|NCT03840239|Other|Watch and wait strategy|Watch and wait strategy recommendation and discussion for cCR patients
15875394|NCT03840226|Drug|Placebo Oral Tablet|Placebo tablets
15875395|NCT03840226|Drug|Magnesium Oxide|Magnesium tablets
15875396|NCT03840213|Behavioral|Filling a questionnaire and interviewDescription|"The questionnaire focuses on the dietary practices of patients treated with chemotherapy. It consists of 35 questions, completing an average of 20 minutes.
~Interviews will be conducted with patients who have changed their diet since the beginning of their treatment in order to further develop the results of the quantitative survey."
15875397|NCT03840200|Drug|Part 1, Dose Level 1 and Dose Level 2a: Ipatasertib|Ipatasertib, 300 mg administered PO QD for 7 days (run-in period prior to Cycle 1), then administer 300 mg PO QD for each cycle. Each cycle has 28 days. Doses are administered until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
15875398|NCT03840200|Drug|Part 1, Dose level 2b and dose level 3: Ipatasertib|Ipatasertib, 400 mg administered PO QD for 7 days (run-in period prior to Cycle 1), then administer 400 mg PO QD for each cycle. One cycle has 28 days. Doses are administered until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
15875399|NCT03840200|Drug|Part 1, Dose Level 1 and Dose Level 2b: Rucaparib|Rucaparib is administered 400 mg twice daily (BID) for each cycle. One cycle has 28 days. Doses are administered until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
15875400|NCT03840200|Drug|Part 1, Dose Level 2a and Dose Level 3: Rucaparib|Rucaparib is administered 600 mg twice daily (BID) for each cycle. One cycle has 28 days. Doses are administered until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
15875401|NCT03840187|Diagnostic Test|Digital cervicography|Colposcopist findings and digital cervicography employing Gynescope system
15875402|NCT03840174|Biological|V160|V160 administered as a 0.5 mL (100 Units) IM injection containing 225 mcg aluminum phosphate adjuvant (APA)
15875403|NCT03840174|Other|Placebo|Saline solution administered as a 0.5 mL IM injection
15875404|NCT03840161|Device|non-invasive tissue glucose prediction|Generation of non-invasive and invasive glucose readings for comparison with a standard laboratory reference glucose determination method (YSI glucose analyzer)
15875405|NCT03840148|Drug|Cefepime/VNRX-5133 (taniborbactam)|Cefepime/VNRX-5133 administered q8h intravenously (IV) over a 2-hour period for 7 days (up to 14 days for patients with bacteremia). Patients will also receive meropenem placebo administered via IV over 30 minutes.
15875406|NCT03840148|Drug|Meropenem|Meropenem will be administered q8h IV over 30 minutes for 7 days (up to 14 days for patients with bacteremia). Patients will also receive cefepime/VNRX-5133 placebo administered via IV over a 2-hour period.
15875407|NCT03840135|Drug|Polyoxidonium 6 mg/ml|"Nasal and sublingual spray Polyoxidonium 6 mg/ml will be administered at a dose of 0,15 mg/kg daily for 7 days:
~in children aged from 1 to 2 years - 1 spray sublingually 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 spray intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spray intranasally (in each nasal passage) 2 times a day (every 12 hours)."
15875408|NCT03840135|Other|Placebo|"Placebo nasal and sublingual spray will be administered for 7 days:
~in children aged from 1 to 2 years - 1 spray sublingually 2 times a day (every 12 hours); in children aged from 2 to 5 years - 1 spray intranasally (in each nasal passage) 2 times a day (every 12 hours; in children aged from 5 to 8 years - 1 spray intranasally (in each nasal passage) 3 times a day (every 8 hours); in children aged from 8 to 12 years - 2 spray intranasally (in each nasal passage) 2 times a day (every 12 hours)."
15875409|NCT03840122|Other|ACB + IPACK block with injection of local anesthetic|"ACB + IPACK block with injection of local anesthetic which is comprised of the following agents and amounts:
~Ropivacaine 5mg/ml (49.25ml)
~Epinephrine 1mg/ml (0.5ml)
~Ketorolac 30mg/ml (1ml)
~Clonidine 0.1mg/ml (0.8ml)
~Saline 48.45ml"
15875410|NCT03840122|Other|ACB + IPACK block without injection|ACB + IPACK block without an injection of local anesthetic
15875411|NCT03840109|Behavioral|Questionnaire 1a|Participants will be randomly shown two versions of messages in which the last 20% of the message consists of negative statements of criticism and rate of the effectiveness of the message.
15875412|NCT03840109|Behavioral|Questionnaire 1b|Participants will be randomly shown two versions of messages in which the first 20% of the message consists of negative statements of criticism and rate of the effectiveness of the message.
15875413|NCT03840109|Behavioral|Questionnaire 2a|Participants will be randomly shown two versions of messages in which the last 40% of the message consists of negative statements of criticism and rate of the effectiveness of the message.
15875414|NCT03840109|Behavioral|Questionnaire 2b|Participants will be randomly shown two versions of messages in which the first 40% of the message consists of negative statements of criticism and rate of the effectiveness of the message.
15875415|NCT03840109|Behavioral|Questionnaire 3a|Participants will be randomly shown two versions of messages in which the last 60% of the message consists of negative statements of criticism and rate of the effectiveness of the message.
15875416|NCT03840109|Behavioral|Questionnaire 3b|Participants will be randomly shown two versions of messages in which the first 60% of the message consists of negative statements of criticism and rate of the effectiveness of the message.
15875417|NCT03840109|Behavioral|Questionnaire 4a|Participants will be randomly shown two versions of messages in which the last 80% of the message consists of negative statements of criticism and rate of the effectiveness of the message.
15875418|NCT03840109|Behavioral|Questionnaire 4b|Participants will be randomly shown two versions of messages in which the first 80% of the message consists of negative statements of criticism and rate of the effectiveness of the message.
15875419|NCT03840096|Device|Breg Flex|All subjects in the treatment group will receive quadriceps Neuro Muscular Electrical Stimulation using Breg Flex device on the affected leg to guide and monitor of knee HEP during the 6 weeks prior to surgery and 12 weeks following surgery.
15875420|NCT03840083|Behavioral|Sleep|Participants will sleep (either a mid-day nap or normal overnight sleep)
15875421|NCT03840070|Device|Potenfill|Maximum: 22ml
15875422|NCT03840057|Drug|Azithromycin Injection|Azithromycin, a semi-synthetic macrolide antibiotic derived from erythromycin. The role of azithromycin as a prokinetic agent was first reported in a retrospective cohort study, which showed azithromycin to be equivalent to erythromycin in accelerating gastric emptying in patients with gastroparesis. The aim of this intervention arm is to evaluate the effectiveness of azithromycin as a prokinetic agent in the management of UGIB.
15875423|NCT03840057|Drug|Metoclopramide Injectable Solution|Metoclopramide, a 5-HT4 agonist and a dopamine D2-receptor antagonist, is approved for short-term treatment of gastroparesis. The use of metoclopramide as a prokinetic agent in the setting of UGIB has been previously studied, but the number of subject involved was too low to adequately power the studies. The aim of this intervention arm is to further evaluate the effectiveness of metoclopramide as a prokinetic agent in the management of UGIB.
15875424|NCT03840057|Drug|Sodium chloride 0.9%|Normal saline is used as a placebo control.
15875425|NCT03840044|Other|Cold air exercise test|Subjects will perform a submaximal 90 minutes exercise test in a controlled cold air environment (-5°C, 60% relative humidity) in a climate chamber with evaluation pre§/during*/post§ of heart rate (HR)§* and blood pressure (BP)§*, spirometry§*, PNIF§, FeNO§, electrocardiogram (ECG)§*, body & exhaled air temperature§*, capsaicin cough threshold test§, histamine bronchial challenge test§, and sampling of nasal fluid§, induced sputum§, and venous blood§.
15875426|NCT03840031|Other|High Fe OFSP meal labelled with Fe-58|400 gram steamed, mashed OFSP high Fe with 0.33 mg FeSO4-58 daily for 10 days
15875427|NCT03840031|Other|Control OFSP meal labelled with Fe-57|400 gram steamed, mashed OFSP control with 0.33 mg FeSO5-57 daily for 10 days
15875428|NCT03840018|Other|Letter by post to patients|Patients received an informative letter by post, in which their doctor invited them to seek an appointment for a medication review
15875429|NCT03840005|Drug|Ursonorm|Ursodeoxycholic acid
15875430|NCT03839992|Diagnostic Test|spirometry|measure spirometry and lung CT
15875431|NCT03839979|Diagnostic Test|BIOLINE HCV kits|We used BIOLINE HCV kits to detect the presence of HCV antibodies in stick blood samples of all recruited patients.
15875432|NCT03839979|Diagnostic Test|ACCU-CHEK kits|For all patients, we measured random blood sugar levels by stick blood samples using ACCU-CHEK kits.
15875433|NCT03839979|Diagnostic Test|ErKameter 3000 mercury manometer|For all patients, we measured systolic blood pressure using ErKameter 3000 mercury manometer.
15875434|NCT03839966|Behavioral|Interpretation Bias Modification for Loneliness|Participants will receive eight treatment sessions. They will be presented with ambiguous training scenarios on a computer screen. Scenarios will be presented in two discrete formats: a word-sentence relatedness task (adapted from Beard & Amir, 2008 and Beard, Weisberg, & Amir, 2011), and a sentence completion and comprehension task (adapted from paradigms used by Mathews and Mackintosh (2000), Steinman and Teachman (2010), and Beard and Amir (2008)). Both of these formats have been used to reduce maladaptive threat interpretations and increase benign interpretations.
15875435|NCT03839966|Behavioral|Healthy Habits Psychoeducation and Relaxation|Participants will receive eight computerized sessions consisting of psychoeducation on healthy behaviors as well as relaxing video clips with pleasant music (e.g., videos of rainforests, wildlife, and space). These sessions will be matched for time with the active condition, lasting approximately 25-30 minutes each. Psychoeducation will cover the topics of exercise, diet, hygiene, social support, healthy activities, and sleep. The relaxing videos will be presented after the psycho-education in each session. At the conclusion of the study, participants will be provided with the active IBM treatment free of charge if they wish to receive it.
15875436|NCT03839953|Behavioral|Supervised Exercise Program|This intervention is a 12-week supervised exercise program at an established cardiac rehabilitation facility.
15875437|NCT03839953|Other|Best Medical Therapy|After undergoing revascularization for critical limb ischemia, patients will receive best medical therapy under the supervision of a vascular internal medicine specialist. This care will include advice on smoking cessation, physical activity guidelines, blood pressure regulation, statin administration and possible anti-platelet administration.
15875438|NCT03839940|Drug|Dexamethasone|Given as mouthwash
15875439|NCT03839940|Other|Placebo|Given as mouthwash
15875440|NCT03839940|Other|Questionnaire|Ancillary studies
15875441|NCT03839940|Other|Quality-of-Life Assessment|Ancillary studies
15875442|NCT03839940|Drug|Everolimus|Standard of care
15875443|NCT03839927|Other|Validity and reliability of Life-Space Assesment|Life-Space Assesment and SF-36 surveys will be applied. The reliability and validity of the results will be analyzed.
15875444|NCT03839914|Drug|Vancomycin powder|For the intervention group, the use of 1g vancomycin powder to be placed in the deep wound and subcutaneous layer prior to closure.
15875445|NCT03839901|Other|Home exercise program|Home exercise programme with participants followed up at week 1, 4, 6 and 8.
15875446|NCT03839888|Drug|0.125% Atropine|patients used 0.125% atropine eyedrop per night before sleep for 7 days.
15875447|NCT03839875|Drug|Gynomax® XL Vaginal Ovule|tioconazole, tinidazole, lidocaine
15875448|NCT03839862|Drug|TNF-inhibition|Initiation of immunosuppression with any TNF-inhibitor, e.g. infliximab, etanercept or adalimumab
15875449|NCT03839849|Procedure|: i-PRF|The description of this intervention has been already given before
15875450|NCT03839849|Procedure|saline|The description of this intervention has been already given before
15875451|NCT03839836|Other|Backpack child's body weight|Children are asked to walk naturally, facing forward, with their hands out of pockets; wearing light, comfortable clothes, with the BP placed correctly. As the children start walking, the researchers select the foot of the first step inside the bars, in the Optogait software. After being instructed to 'walk slowly at a comfortable speed', the children walk from a point two metres in front of the bar and stop at a point two metres behind the last bar, to minimize effects of acceleration and deceleration . A three-minute interval occurs between individual assessments to transmit the data, as well as to prepare for the next assessment. Only steps in the sensor areas are included in the analysis. Recording six to eight strides is reported as sufficient to obtain representative data for unimpaired adults. Subsequently, five experimental conditions are measured: without BP, BP loads of 5%, 10%, 15%, and 20% of body weight. The order of these loaded conditions are random.
15875452|NCT03839823|Combination Product|Docetaxel / Capecitabine|"Docetaxel (IV Infusion) / Capecitabine (Tablets for oral use):
~Docetaxel once, on day 1 of the 3-weeks cycle. Capecitabine twice daily, on Days 1 to 14, followed by a 1-week rest period, in 3 weeks cycle.
~Docetaxel (60 - 75 mg/m²)/capecitabine (1600 - 2500 mg/m²/day)"
15875453|NCT03839823|Combination Product|Capecitabine / Vinorelbine|"Capecitabine (Tablets for oral use) / Vinorelbine (Capsule for Oral use/IV infusion ).
~Capecitabine twice daily on day 1 to 14, followed by a 1-week rest period, in 3 weeks cycle.
~Vinorelbine, once, on Day 1 and Day 8 in 3 weeks cycles.
~Capecitabine (1600 - 2500 mg/m2/day)/vinorelbine (60 to 80 mg/m2/day [oral] or (25 to 30 mg/m2 [IV infusion]"
15875454|NCT03839823|Combination Product|Paclitaxel / Gemcitabine|"Paclitaxel (IV Infusion) / Gemcitabine (IV Infusion):
~Paclitaxel via 3-hour intravenous (IV) infusion on Day 1 in 3-weeks cycles, OR Paclitaxel via 1 hour intravenous (IV) infusion on Day 1 and day 8- in 3-weeks cycles.
~Gemcitabine at via 30 minute IV infusion on Day 1 and Day 8 in 3 weeks cycles.
~Paclitaxel (175 mg/m2) (on Day 1 in 3-weeks cycles)/ gemcitabine (1000 - 1250 mg/m2)
~OR
~Paclitaxel (80 - 90 mg/m2) (on Day 1 and Day 8 in 3-weeks cycles) / gemcitabine (800 - 1250 mg/m2)"
15875455|NCT03839823|Drug|Ribociclib|Dose: 600 mg (200 mg * 3) Days 1 to 21 of each 28 day cycle Tablets for oral use
15875456|NCT03839823|Drug|Letrozole OR Anastrozole|"Letrozole:
~Dose: 2.5 mg All days of every cycle without interruption). Tablets for oral use
~Anastrozole:
~dose: 1 mg All days of every cycle without interruption. Tablets for oral use
~The NSAI (letrozole or anastrozole) will be decided by the treating physician."
15875457|NCT03839823|Drug|Goserelin|"Dose: 3.6 mg Day 1 of each 28 day cycle (regardless of ribociclib treatment cycle) with an administration window of + 3 days.
~Subcutaneous implant"
15875458|NCT03839810|Other|stochastic resonance electrical stimulation|"stochastic resonance electrical stimulation is applied in the upper extremity during motor functional training.
~Sham comparator group uses sham stimulation - same electrode location, but no electrical current is applied during motor functional training"
15875459|NCT03839797|Behavioral|Cadet Healthy Personal Skills|7.5 hour skills training group intervention
15875460|NCT03839797|Behavioral|Standard Health Education|Standard Health Education
15875461|NCT03839784|Combination Product|Neurocognition Interventions|EEG, Neurocognitive Battery Testing, and Immune Profiles
15875462|NCT03839771|Drug|AG-120|250mg tablets
15875463|NCT03839771|Drug|Placebo for AG-120|250mg tablets
15875464|NCT03839771|Drug|AG-221|100mg tablets
15875465|NCT03839771|Drug|Placebo for AG-221|100mg tablets
15875466|NCT03839758|Procedure|TSA standard|Glenoid preparation will be done with 2D CT-Scan
15875467|NCT03839758|Procedure|RTSA standard|Glenoid preparation will be done with 2D CT-Scan
15875468|NCT03839758|Procedure|TSA Blueprint|Glenoid preparation will be done with Blueprint software
15875469|NCT03839758|Procedure|RTSA Blueprint|Glenoid preparation will be done with 2D CT-Scan
15875470|NCT03839745|Other|Electronic Cigarette|E-cigarette Device: The delivery device will be a variable wattage all-in-one device with operating wattage of 7.0 - 75.0 W, which is inclusive of the three power levels we intend to study.
15875471|NCT03839732|Diagnostic Test|Score of abdominal aorta calcifications|Radiographs showing VC will be used to assess whether the computer assisted VC scoring (primary objective) and Quantitative Vertebral Morphometry (QVM, limited to lumbar spine, secondary objective n.1) through the Calcify2D software are less variable with respect to the traditional visual scoring of VC and QVM.
15875472|NCT03839719|Procedure|Group PI|Before rinsing with the mouthrinse, Ultrasonic scaling was done in the 1st and 4th quadrant without any mouth rinse (placebo mouthrinse) and fall out samples were collected in the blood agar plates kept at a distance of 0.5 m and 1 m from the oral cavity.
15875473|NCT03839719|Procedure|Group OC|After ultrasonic scaling of the 1st and 4th quadrant minimum 30min interval maintained. After interval of 30min rinsing the mouth with the either OC/CHX/Placebo (OC= Ocimum sanctum mouthrinse, CHX=Chlorhexidine Gluconate mouthrinse) mouthrinse) done for 60s, Ultrasonic scaling was again done in the 2nd and 3rd quadrant and fall out samples were collected in the newly placed blood agar plates kept at 0.5 m and 1 m away from the patient.
15875474|NCT03839719|Procedure|Group CHX|After ultrasonic scaling of the 1st and 4th quadrant minimum 30min interval maintained. After interval of 30min rinsing the mouth with the either OC/CHX/Placebo (OC= Ocimum sanctum mouthrinse, CHX=Chlorhexidine Gluconate mouthrinse) mouthrinse) done for 60s, Ultrasonic scaling was again done in the 2nd and 3rd quadrant and fall out samples were collected in the newly placed blood agar plates kept at 0.5 m and 1 m away from the patient.
15875475|NCT03839706|Device|PET MRI|18F-Fluorodeoxyglucose Positron Emission Tomography combined with Primovist MRI
15875476|NCT03839693|Biological|botulinum toxin, Type A|topical liniment
15875477|NCT03839693|Biological|Vehicle|Vehicle Formulation
15875478|NCT03839680|Procedure|Endoscopy|The endoscopy procedure uses an endoscope to examine the interior of a hollow organ or cavity of the body.
15875479|NCT03839667|Behavioral|intensive diet intervention|the participants will be instructed to restrict the total daily calorie intake to 800 kcal by receiving the very-low-calorie meal replacement formula for 2 consecutive days per week. They will be allowed to maintain their normal diet in the remaining 5 days, but need to restrict total intake to 2000 kcal per day.
15875480|NCT03839667|Behavioral|Enhanced physical activity intervention|the participants will take high-intensity exercise in accordance with High Intensity Interval Training (HIIT) prescriptions, with maximum heart rate and relative maximal oxygen uptake monitored. They will take both aerobic and resistance training exercise consecutively, and total training time will be expected to reach at least 150 minutes per week.
15875481|NCT03839667|Behavioral|Standard education|the participants will receive no extra intervention but diabetes health education, which will be carried out in large classrooms, in groups, and over the telephone. The education is mainly consisted of instructions on healthy diet and exercise plans, prevention for acute and chronic complications and self-glycemic monitoring.
15875482|NCT03839654|Device|continuous positive airway pressure|The CPAP treatment group received both baseline medicine and CPAP treatment for 7 days preoperatively.
15875483|NCT03839641|Other|High fat meal|60% fat meal
15875484|NCT03839641|Other|Low fat meal|20% fat meal
15875485|NCT03839628|Other|Reduced Physical Activity|Participants will reduce their level of physical activity for 2-weeks as defined as approximately 75% reduction from their baseline level of physical activity.
15875486|NCT03839615|Procedure|guided bone regenerations|"intra oral procedures.
~Flap will be done.
~In the study group: bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral mineral will be packed then covered at the defected area by a native collagen membrane which will be stabilized by tacks.
~In the control group: : bone decortication will be done using surgical round bur, autogenous bone will be harvested by trephine bur ,mixed 1:1 with anorganic bovine bone derived mineral and packed at the defected area then covered by a titanium reinforced polytetraflouroethelene membrane which will be stabilized by tacks.
~The site will then be copiously irrigated with saline in preparation for closure.
~The flap will then be closed using interrupted 4/0 resorbable sutures."
15875487|NCT03839602|Radiation|Reducing CTV|CTVs were delineated in line with tumor stage, i.e. tumor invasion.
15875488|NCT03839589|Behavioral|Mindfulness Based Stress Reduction Adapated (MBSR-A)|Mindfulness-based stress reduction (MBSR) is a group-based intervention developed in 1979 by Dr. Jon Kabat-Zinn to provide mindfulness training in order to decrease stress and improve overall well-being. MBSR has been shown to be effective for a series of patient outcomes including depression, anxiety disorders, sleep disorders, and chronic pain management. MBSR is a structured intervention delivered through an 8-week course of up to 30 participants who meet for 2.5 hours per week.
15875489|NCT03839576|Behavioral|Exercise|Each session will last 60 min, consisting of 10 min of warm-up, 45 min of exercise, and a 5-min cool-down.
15875490|NCT03839576|Behavioral|Computerized training|Attention, memory, speed of processing, and executive functioning.
15875491|NCT03839563|Behavioral|Exercise|Each session will last 60 min, consisting of 10 min of warm-up, 45 min of exercise, and a 5-min cool-down.
15875492|NCT03839550|Combination Product|Apatinib Mesylate +SHR-1210|"Apatinib mesylate tablets: 250 mg, orally once a day. Take about half an hour after a meal with warm water (the daily dose should be as much as possible.
~SHR-1210: 200mg, intravenous infusion for 30 minutes (including the time of the tube, the overall infusion time is not shorter than 20 minutes, no longer than 60 minutes), once every 2 weeks. A total of 6 months of treatment,starting 4-8 weeks after radical hepatic resection."
15875493|NCT03839550|Procedure|Hepatic Arterial Infusion(HAI)|Twice standard HAI treatment, the first treatment was performed 4-8 weeks after radical hepatic resection, and the second treatment was given 4-8 weeks after the first treatment (the specific time interval depends on the recovery of liver function of the patient). The specific dosage regimen is 80-100 mg of epirubicin or 50 mg of epirubicin + oxaliplatin 50 mg per HAI treatment.
15875494|NCT03839537|Other|Exposure measurement|"2 measurements per subject (in warm season and in cold season)
~Devices placed inside taxi vehicles on the passenger seat in a sampling bag"
15875495|NCT03839537|Other|Spirometry test|"2 measurements per subject - before and after the work shift - in warm and cold seasons
~Subject will inhale and exhale in the device"
15875496|NCT03839537|Diagnostic Test|Exhaled carbon monoxide test|"2 measurements per subject - before and after the work shift - in warm and cold seasons
~Subject will exhale in the device"
15875497|NCT03839537|Diagnostic Test|Skin allergy test|- Performed by a physician during the inclusion clinical examination
15875498|NCT03839537|Diagnostic Test|Spirometry test|- Performed by a physician during the inclusion clinical examination
15875499|NCT03839537|Diagnostic Test|Fractional Exhaled Nitric Oxide Testing|- Performed by a physician during the inclusion clinical examination
15875500|NCT03839524|Drug|TG4050|Subcutaneous injections weekly for the first 6 weeks and then every 3 weeks.
15875501|NCT03839511|Procedure|Hyperinsulinemic-hypoglycemic clamp|Subjects will arrive at the inpatient unit in the morning after at least a 10 hour overnight fast. Upon arrival to PBRC, participants will be admitted to the inpatient unit. Following measurement of weight, vitals, and pregnancy test (women only), the 4-hour hypoglycemic clamp procedure (30 minute baseline, 120 minute insulin infusion, and 90 minute recovery) will be performed. Upon completion of the clamp procedure, participants will be provided lunch (Standard American Diet). Following lunch, the CGM sensor will be removed and pending a stable blood glucose level in the normal range, the participant will be discharged from the inpatient unit. This completes the study.
15875502|NCT03839498|Drug|Axitinib|"Axitinib (AG-013736) is an oral, potent and selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2, and 3.
~Starting dose level 1: 5 mg every morning; 5 mg every evening. Dose level 2: 7 mg every morning; 7 mg every evening. Dose level 3: 10 mg every morning; 10 mg every evening. Dose level -1: 3 mg every morning; 3 every evening. Dose level -2: 2 mg every morning; 2 mg every evening.
~Axitinib is supplied as 1 and 5-mg tablets and is administered orally twice a day with or without food, each morning and evening (i.e., every 12 hours). Axitinib will be given as self-administered."
15875503|NCT03839485|Drug|Endodontic treatment using Guedes-Pinto Paste|Dental procedure in which the entire pulp chamber is removed from the crown and roots of a tooth and the root filling material Guedes-Pinto paste is applied
15875504|NCT03839485|Drug|Endodontic using Guedes-Pinto Paste without antibiotic|Dental procedure in which the entire pulp chamber is removed from the crown and roots of a tooth and the root filling material Guedes-Pinto paste without antibiotic is applied
15875505|NCT03839472|Procedure|CBI|CBI with 5 liters normal saline in 1 liter increments up to 2 hours after TURBT procedure.
15875506|NCT03839459|Drug|Denosumab|120mg of Denosumab will be administered subcutaneously once every 4 weeks
15875507|NCT03839446|Drug|mitoxantrone + etoposide + gemtuzumab ozogamicin|10 mg/m2 mitoxantrone days 1-5 + 100mg/m2 etoposide days 1-5 + 3mg/m2 gemtuzumab ozogamicin on day 6.
15875508|NCT03839433|Drug|Ciclesonide|
15875509|NCT03839420|Device|CZM IOL|implantation of CZM IOL
15875510|NCT03839420|Device|Competitor IOL|implantation of Competitor IOL
15875511|NCT03839407|Device|MUSE Meditation Device|The MUSE Meditation Device guides users in mindful meditation using real-time feedback on brain wave activity.
15875512|NCT03839394|Behavioral|Telephone|A series of educational pamphlets on CVD risk reduction plus a telephone-based CVD risk reduction curriculum will be administered by Clinic-Based Case Managers (CCMs). Six modules will be given over 24 weeks in a rotating fashion on topics relevant to CVD risk. Subjects will be given the pamphlets every 2 weeks corresponding with the first time they receive the telephone - based module.
15875513|NCT03839394|Other|Educational pamphlets|A series of 6 handouts will be given to controls once monthly over 6 months on the same topics presented in the telephone modules. Educational packets will be primarily drawn from free printed material available at www.learningaboutdiabetes.org and the American Heart Association website.
15875514|NCT03839368|Procedure|fixation of angle fracture|open reduction and internal fixation of angle fracture
15875515|NCT03839355|Drug|Apixaban|Dosage either 5mg or 2.5mg for 2 years
15875516|NCT03839355|Drug|Warfarin|Dosage assessed by your treating physician for 2 years
15875517|NCT03839342|Drug|Binimetinib|MEK inhibitor, 45mg oral tablet
15875518|NCT03839342|Drug|Encorafenib|BRAF inhibitor, 450mg oral capsule
15875519|NCT03839329|Behavioral|Acceptance and Commitment Training|Acceptance and Commitment Therapy is an acceptance- and mindfulness-based psychotherapy that aims to foster psychological flexibility.
15875520|NCT03839316|Device|tDCS|A constant current stimulator (ZMI Electronics LTD.,Taiwan,2012) will be used through 2 saline-soaked surface gel-sponge electrodes (22 cm2 active area). Real stimulation consisting of thirty minutes of 2 mA direct current with the anode placed over the ipsilesional and the cathode over the contralesional motor cortex (C3 and C4 of the international 10-20 EEG electrode system).
15875521|NCT03839316|Device|sham tDCS|For sham tDCS, the same electrode positions were used. The current was ramped up to 2 mA and slowly decreased over 30 seconds to ensure the typical initial tingling sensation
15875522|NCT03839303|Device|Infra-zygomatic Mini Implant Supported Appliance|"leveling and alignment of the four maxillary incisors
~infra zygomatic mini-implant will be placed bilaterally
~wire frame work that is designed resembling the inner bow of headgear will be adapted to the upper arch
~a heavy arch wire engaging the 4 incisors will be attached to the wire frame work
~orthopedic force will be delivered from the mini-implants to the wire frame work"
15875523|NCT03839303|Device|high pull head gear|"acrylic maxillary splint is made with flying tubes
~high pull head gear is adapted to be inserted in the flying tubes"
15875524|NCT03839290|Procedure|Early neonatal cheiloplasty|
15875525|NCT03839277|Device|Endocuff Vision|Endocuff Vision is attached to the tip of colonoscope before intubation.
15875526|NCT03839264|Diagnostic Test|Graft stenosis and thrombosis|
15875527|NCT03839251|Drug|abilify maintena|aripiprazole 400mg or 300mg, IM, Once a month
15875528|NCT03839238|Biological|hESC derived MSC like cell|Different dosage of hESC derived MSC like cell for the meniscus injured patients
15875529|NCT03839225|Other|Community intervention|"Community intervention will be built depending on contextual factors and will contain the following elements:
~Cross-sector intervention, including sectors to define the intervention as primary health care services, education services (language, knowledge to prevent health problems and resilience strategies), family welfare units, Integral Care and Reparation Unit for Victims (UARIV), Ministry of Labour, national and international social support network, among others.
~The leader will be chosen by the community, with the capabilities to coordinate the community-based network.
~Mental health providers at the local level, who must develop psychosocial and mental diagnoses and interventions, based on experience and evidence, respectively. This team will include psychiatry, psychologists (one an expert in clinical psychology) and a community team involved in the implementation of mental interventions."
15875530|NCT03839212|Behavioral|HOLA Component 1|At week 1 and week 8 participants will meet individually with Community Health Worker (CHW) for 30 minutes for a manualized social and physical activation session.
15875531|NCT03839212|Behavioral|HOLA Component 2|A CHW led 45 minute (10 minutes of stretching and warm up, followed by 30 minutes of walking with a 5 minute cool down) group walk session of six participants at a time done 3 times a week that utilized interval training that slowly gradually increases in intensity.
15875532|NCT03839212|Behavioral|HOLA Component 3|A CHW led pleasant event discussion, asking each participant to identify a pleasant event. This task is done in conjunction with the cool down of HOLA 2.
15875533|NCT03839212|Behavioral|HOLA Component 4|One booster walking session twice a month for three months post intervention for reinforcement.
15875534|NCT03839173|Other|Human milk based human milk fortifier|A human milk fortifier with added minerals made from donor human milk
15875535|NCT03839160|Procedure|Serratus anterior plane block|Serratus anterior plane block was applied in Group S. It was performed at the end of the operation following the skin closure, while the patient lay on his side with his arm above the head. After proper site cleaning, the first and second ribs were identified with a linear probe in the midclavicular line. The USG probe was advanced caudally in the sagittal plane, and the fourth and fifth ribs were visualized. The USG probe was then directed posteriorly and the serratus, latissimus dorsi and intercostal muscles were visualized. Bupivacaine 0.25% 30 mL was administered to the lower plane of the serratus muscle through an inserted catheter under the guidance of USG through the in-line technique. Afterwards, 0.12% bupivacaine hydrochloride was maintained at the rate of 0.1ml/kg/hr.
15875536|NCT03839160|Drug|Intravenous patient-controlled-analgesia morphine|Morphine solution was prepared at a concentration of 0.5 mg/mL with the device programmed to 2 mg of bolus dose and 10 min of locking time.
15875537|NCT03839147|Behavioral|Education and counseling|After obtaining informed consent, the data collection form, Spielberger State Anxiety Scale and VAS scoring scale were applied to both groups by face to face interview during the day giving appointment for HSG. Immediately after the questionnaires were answered, individual education and counseling were giving by the nurse researcher to intervention group for 30 minutes. In addition, the education and counseling given to the participants by the researcher was repeated briefly on the morning of the HSG procedure and any questions of the patients were answered.
15875538|NCT03839134|Device|DentalVibe® Comfort Injection System|Soft tissue vibration for 10 seconds using DentalVibe®. The device induces approximately 16 soft tissue vibrations of per second. The device will be in touch of oral mucosa (at the site of injection) before and during the local anesthesia injection.
15875539|NCT03839134|Drug|Lidocaine Epinephrine|Dental local anesthesia injection of 1.8 mL Lidocaine (2%) with Epinephrine (1:80000 w/v).
15875540|NCT03839121|Device|Cardiac Resynchronization Therapy (CRT)|Observation and documentation of CRT patients
15875541|NCT03839108|Other|Paraffin wax|Paraffin group patients will be told to take of jewellery and dip their hands into the bath of melted wax (52 ºC) with hands open and hand wrist in neutral position for 10 times .In paraffin wax group, patients will be treated 5 days a week for 2 weeks period. Paraffin wax bath will be applied for 20 minutes in every physical therapy session.
15875542|NCT03839108|Drug|Prolotherapy|. Prolotherapy is a nonsurgical regenerative injection technique that introduces small amounts of an irritant solution to the site of painful and degenerated tendon insertions (entheses), joints, ligaments, and in adjacent joint spaces during several treatment sessions to promote growth of normal cells and tissues.Hypertonic dextrose solution is most common used agent. In prolotheraphy group, %15 dextrose solution will be applied to medial and lateral aspect of proximal interphalangeal joints (PIJ), distal interphalangeal joints and carpometacarpal joint of thumb for 3 sessions once a week period
15875543|NCT03839082|Other|Usual Care then FitBit|Usual care is a visit (15-20 mins) every 6-12 months. Usual care includes a Fibroscan (FDA 510(k) device).
15875544|NCT03839082|Other|FitBit then Usual Care|Intervention is tailored physical activity and nutritional counseling. Step counts are monitored by a FitBit Zip. A Fibroscan (FDA 510(k) device) is done.
15875545|NCT03839069|Procedure|minor salivary gland transplantation|The investigators will harvest the autologous labial salivary gland tissue and transplant to the upper and lower conjunctival fornix of the lesion eye.
15875546|NCT03839056|Device|IC+PIEB+PCEA high flow|"Ropivacaina 0,1 % is used with fentanilo 2ug/ml Also if during the dilation period a greater or equal AVE appears to 4 (inadequate analgesia) the patient can be administered a bolus of PCEA of the same solution.
~If the patient is administered PCEA, the programed intermittent epidural bolus is delayed automatically 20 minutes with regard to the time in which it would have to be administrated.
~If after two bolus of PCEA the analgesia keeps on being ineffective a clinical bolus is administered by the anaesthetist of 4ml of lidocaína to 1 %.
~This intervention is included in the clinical practice routine"
15875547|NCT03839056|Device|PIEB+PCEA high flow|"Ropivacaina 0,1 % is used with fentanilo 2ug/ml Also if during the dilation period a greater or equal AVE appears to 4 (inadequate analgesia) the patient can be administered a bolus of PCEA of the same solution.
~If the patient is administered PCEA, the programed intermittent epidural bolus is delayed automatically 20 minutes with regard to the time in which it would have to be administrated.
~If after two bolus of PCEA the analgesia keeps on being ineffective a clinical bolus is administered by the anaesthetist of 4ml of lidocaína to 1 %.
~In the group of pure boluses 10ml / h of perfusion will be administered through the high flow and standard flow infusion system, and the maximum sensory level achieved will be compared.
~This intervention is included in the clinical practice routine"
15875548|NCT03839056|Device|PIEB+PCEA standar flow|"Ropivacaina 0,1 % is used with fentanilo 2ug/ml Also if during the dilation period a greater or equal AVE appears to 4 (inadequate analgesia) the patient can be administered a bolus of PCEA of the same solution.
~If the patient is administered PCEA, the programed intermittent epidural bolus is delayed automatically 20 minutes with regard to the time in which it would have to be administrated.
~If after two bolus of PCEA the analgesia keeps on being ineffective a clinical bolus is administered by the anaesthetist of 4ml of lidocaína to 1 %.
~In the group of pure boluses 10ml / h of perfusion will be administered through the high flow and standard flow infusion system, and the maximum sensory level achieved will be compared.
~This intervention is included in the clinical practice routine"
15875549|NCT03839043|Behavioral|Brief behavioral intervention|"Quit for a bit- *advice to quit from the am. of surgery until one week post-surgery, a special emphasis on morning abstinence* risks of smoking to perioperative outcomes, includes wound infections, breathing problems, and heart problems*reduction of these risks if able to quit for a bit*the fact that most smokers don't experience cravings or increased stress around the time of surgery. Subjects will receive written summarizing instructions and a brief abstinence brochure. Quit for good- 3 out of the 5A's smoking cessation intervention, including Asking, Advising and Assistance will be provided. The advice endorses immediate, sustained quitting (quit for good), accent on the health and economic benefits of long-term abstinence. Assistance includes a method of setting the date of surgery as the quit date, enlisting social support, anticipation of withdrawal symptoms, and the need for complete abstinence. Subjects will receive written summarizing instructions and a 5As brochure."
15875550|NCT03839043|Other|SMS Program|"Quit for a bit- Subjects will get SMS messages focused on maintaining abstinence from the morning of surgery until one week after surgery. SMS content focus on the benefits of abstinence to surgical recovery rather than sustained benefits to overall health. Around day 7 postoperatively, messages will encourage subjects to consider extending their abstinence beyond 7 days.Quit for good- Subjects will get SMS messages focused on general advice for maintaining abstinence, focusing on the long-term health benefits rather immediate benefits to recovery from surgery. SMS content focus on the the surgical date as the quit date, general advice and support for quitting based on the standard Truth Initiative (UbiQUITxt) message library and there will be no references to effects of short-term abstinence on surgical outcomes."
15875551|NCT03839030|Other|MBHP-Educa|This intervention is a meditative practice which the individuals will practice in their daily life following the MBHP-educa protocol
15875552|NCT03839017|Device|SIMMAXMARCHERYAN2|Digital cognitive aid during the management of simulated war wounded.
15875553|NCT03839004|Behavioral|Integrated approach to pregnancy|Yoga classes, mindfulness classes, coaching, nutrition counselling and osteopathy
15875554|NCT03838991|Other|Blood sample|A study specific blood sample will be collected.
15875555|NCT03838991|Other|Waste bone tissue|For 3 patients of each group, patients having a scheduled surgery, a piece of waste bone tissue will be collected after surgery.
15875556|NCT03838978|Device|Calypso Knee System|The Calypso Knee System is an extra-capsular knee implant designed to fill the therapeutic gap between conservative care and more invasive surgical interventions for knee osteoarthritis.
15875557|NCT03838965|Device|biobeat sensor|biobeat sensor is a noninvasive sensor of the the hymodynamic measures during the childbirth and after 24 hours.
15875558|NCT03838952|Drug|Herbal medicine|Each pack: Jia Wei Xiao Yao San granule(5 gm), Gou Teng granule (1.1 gm),and Ba Ji Tian (1.1 gm), 2 times per day for 12 weeks.
15875559|NCT03838939|Other|Therapeutic education|"Individual and group therapeutic education sessions will consist of :
~acquisition by patient of self-care skills such as performing subcutaneous injection,
~acquisition by patient of safety skills such as identifying symptoms that should lead to consult general practitioner, and stop treatment ..."
15875560|NCT03838926|Drug|Trichostatin A|Intravenous Infusion
15875561|NCT03838900|Device|Loop|The Loop System consists of an insulin pump (certain versions of Medtronic insulin pumps) and a Dexcom or Medtronic CGM. The system includes an iPhone with the Loop app and a RileyLink to communicate between the pump and iPhone. An Apple Watch may optionally be used with the system.
15875562|NCT03838887|Device|ultrasound machine|Ultrasound machine with a vocal software
15875563|NCT03838874|Drug|Low-Dose Bupivacaine|10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic
15875564|NCT03838874|Drug|Mepivacaine|70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic
15875565|NCT03838861|Behavioral|NEMO: NEw MOdel of follow-up|The nurse led model is built upon phone contacts with content and intervals individually planned by the nurse and the patient. The individual contacts will be supported by graphic visualisation of ePROMs in REDCap filled out by the patient before each contact including DGCG's disease specific symptom list and the generic European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) (24) supplemented with the relevant disease-specific add-on module (25, 26). The sum scores are visualised with colours to indicate severe problems (red), no problems (green) and mild or moderate problems (yellow and orange), respectively. Hence, alarm symptoms and problem areas are clearly presented to the project nurse and changes can be visualised over time enhancing the interpretation. The patient will be given access to own scoring results to obtain an understanding of the meaning of changes in health status.
15875566|NCT03838848|Drug|KN046|KN046, Q2W, intravenous injection (IV) for 90-120 minites.
15875567|NCT03838835|Behavioral|Augmented equine-facilitated CBT group program|Consists of CBT strategies including 1) providing psychoeducation about anxiety, 2) teaching coping strategies when anxious,and 3) identifying and addressing dysfunctional thoughts that maintain anxiety.
15875568|NCT03838835|Behavioral|TAU is equine-facilitated group therapy|TAU is equine-facilitated group therapy at GallopNYC, which consists of horseback riding and integrates strategies to support the development of cognitive, physical, emotional, and social skills.
15875569|NCT03838835|Other|WLC|WLC consists of youth who are not yet receiving any services at Gallop NYC.
15875570|NCT03838822|Dietary Supplement|Cofactors|Oral administration of 1g nicotinamide riboside, 3g L-carnitine, 20g serine and 5g N-acetylcystein, first as single compounds, then combined, on 5 days
15875571|NCT03838809|Device|surface electromyography-biofeedback|Two electrodes were putted on the motor point of the extensor muscle of the hand and the foot. The positive electrode was placed on the distal zone of the hand or the foot, while the negative electrode was placed on the proximal zone.
15875572|NCT03838796|Drug|lenvatinib|for patients <60kg, lenvatinib 8mg bid po for patients >60kg, lenvatinib 12mg bid po
15875573|NCT03838796|Procedure|TACE|The patient underwent transfemoral hepatic artery angiography one month after surgery to observe whether there was tumor staining in the liver. If there was suspicious tumor staining, micro-catheter was superselected to the tumor blood vessel, the embolization agents and chemotherapy drugs were injected. If there was no tumor staining, a small amount of embolization agents were slowly injected into the artery.
15875574|NCT03838783|Drug|Insulin Degludec|50% of the patient's daily basal insulin dose delivered through once daily insulin degludec injected in the morning; 50% of the basal insulin to be delivered through previously established CSII
15875575|NCT03838770|Device|Active tDCS|Active target 2.0mA tDCS (n=60)
15875576|NCT03838770|Device|sham tDCS|sham left-anodal dorsolateral prefrontal cortex (DLFPC) montage
15875577|NCT03838744|Drug|Standard arm: Trabectedin in monotherapy|Trabectedin in monotherapy
15875578|NCT03838744|Drug|Experimental arm: Trabectedin + Olaparib|Trabectedin given in combination to olaparib
15875579|NCT03838731|Drug|REGN1908-1909|Single subcutaneous (SC) dose of REGN1908 and REGN1909
15875580|NCT03838731|Drug|Placebo|Single subcutaneous (SC) dose of matching placebo
15875581|NCT03838705|Procedure|hypoxia|It was accepted that hypoxia developed in patients with SpO2< 92 or falling over 20% compared to preoperative values.
15875582|NCT03838705|Procedure|normooxy|It was accepted that patients with SpO2 between 100-92 mmHg
15875583|NCT03838692|Drug|Ponatinib|A daily oral dose at 30 mg.
15875584|NCT03838679|Diagnostic Test|Best-corrected Visual acuity testing (BCVA)|Best-corrected visual acuity (BCVA) will be measured using Early Treatment of Diabetic Retinopathy Study (ETDRS) charts at 4 meters and 1 meter, respectively.
15875585|NCT03838679|Diagnostic Test|Optical coherence tomography (OCT)|Optical Coherence Tomography (OCT) is a non-invasive diagnostic technique that renders an in vivo cross sectional view of the retina.
15875586|NCT03838679|Diagnostic Test|Color fundus photography (CFP)|Color fundus photography is a non-invasive, fast and reliable imaging method providing a true-to-life depiction of the ocular fundus.
15875587|NCT03838679|Diagnostic Test|Optical coherence tomography angiography (OCTA)|OCTA, an extension of conventional OCT, offers noninvasive imaging of the retinal and choroidal vasculature.
15875588|NCT03838679|Diagnostic Test|Polarization-sensitive optical coherence tomography (PS-OCT)|PS-OCT, a functional exten- sion of conventional OCT technology, enables differentiation of retinal layers based on their distinct interference with the polarization state of the probing light beam, as opposed to mere light intensity.
15875589|NCT03838679|Diagnostic Test|Microperimetry (MP)|Microperimetry allows testing of retinal sensitivity at specific locations in the area of the fovea, parafovea or even more peipheral areas of the macula.
15875590|NCT03838679|Diagnostic Test|Adaptive-optics optical coherence tomography (AO-OCT)|AO-OCT, an extension of conventional OCT, offers non-invasive imaging of the retina with improved lateral resolution of up to 2-3 μm.
15875591|NCT03838679|Diagnostic Test|Fluorescein angiography (FA)|FA imaging is a standard imaging technique used for the diagnosis of vascular pathologies of the retina such as choroidal neovascularization.
15875592|NCT03838666|Drug|Suspension of human autologous MSC 3P|Single administration of the suspension of human autologous MSC 3P in 1.5 ml on the surface of the repaired rotator cuff tendon
15875593|NCT03838640|Device|EPIQ 5|As described in summary Trade name of the device Philips EPIQ 5
15875594|NCT03838614|Behavioral|Rhythmical auditory stimulation gait training and muscle power training (RAS-MPT)|The RAS-MPT group will attend a 60-minute training session once a week and home exercises (twice/week) for 12 weeks. Participants will receive two levels of training within each 60-minute session: (1) RAS-treadmill training and (2) MPT.
15875595|NCT03838614|Behavioral|Rhythmical auditory stimulation gait training (RAS)|The RAS group will attend a 60-minute training session once a week and home exercises (twice/week) for 12 weeks. Participants will receive RAS-treadmill training repeatedly within each 60-minute session.
15875596|NCT03838614|Behavioral|Muscle power training (MPT)|The MPT group will attend a 60-minute training session once a week and home exercises (twice/week) for 12 weeks. Participants will receive muscle power training repeatedly within each 60-minute session.
15875597|NCT03838614|Other|Controls|Participants in the control group will receive no intervention during the study period, but continue with their normal daily activities and usual medical care. They will receive the same training as the RAS-MPT group after the study.
15875598|NCT03838601|Drug|MET-4|Microbial Ecosystem Therapeutics (MET) is a new treatment approach developed as an alternative to fecal transplantation. Unlike donor stool used in fecal transplants, which are incompletely characterised complex communities of microbes and associated metabolites and fecal material, MET consists of a defined mixture of pure live cultures of intestinal bacteria isolated from a stool sample of a healthy donor.
15875599|NCT03838575|Drug|2% alcoholic chlorhexidine skin prep (SKIN PREP)|This intervention describes the preparation of the intact skin incision site immediately prior to incision, using chlorhexidine gluconate (CHG) in an alcohol-based solution, providing durable sterilisation of the surgical field. Pre-prepared applicators will be available for use in this trial (ChloraPrep™ sticks, 2% CHG with 70% isopropyl alcohol, BD Infection Prevention).
15875600|NCT03838575|Device|Iodophor Antimicrobial Incise Drapes (DRAPE)|This intervention describes the application of a single Iodophor Antimicrobial Incise Drape to be applied topically onto the prepared and draped surgical field by sterile, gloved members of the surgical team before the surgical incision is performed. Only after the skin preparation solution has dried completely can the incise drape be applied.
15875601|NCT03838575|Device|Gentamicin-impregnated implants/ sponges (SPONGE)|This intervention describes the implantation of Gentamicin-impregnated collagen implants at the time of fascial closure. Each sponge (10 by 10 cm) contains 280mg of collagen and 130mg of gentamicin. The sponges gradually degrade and the gentamicin solution permeates into surrounding tissues to create a high local antimicrobial concentration within the surgical wound.
15875602|NCT03838575|Other|NONE (Control)|"Any skin preparation of the surgeon's choice may be used in the control arm apart from 2.0% Alcoholic Chlorhexidine Skin Prep.
~No drapes or sponges of any kind may be used."
15875603|NCT03838562|Other|Vestibular rehabilitation with virtual reality|"Both group follow three or four weeks of vestibular rehabilitation program with 2 sessions of physical therapy per day and one collective session of balance exercices per day, five day per week. More orthoptist care and muscle strengthening.
~The exercises performed include rotating exercises, static balance exercises with eyes open and closed, head fixed and with head oscillation. Exercises on unstable planes and on dynamic force platforms. Different walking and eye stabilization exercises.
~Only visual misinformation is distinct in both groups. Optokinetic application with three-dimensional head-mounted is used in the experimental group."
15875604|NCT03838562|Other|Standard optokinetic stimulator or dynamic visual surround|"Both group follow three or four weeks of vestibular rehabilitation program with 2 sessions of physical therapy per day and one collective session of balance exercices per day, five day per week. More orthoptist care and muscle strengthening.
~The exercises performed include rotating exercises, static balance exercises with eyes open and closed, head fixed and with head oscillation. Exercises on unstable planes and on dynamic force platforms. Different walking and eye stabilization exercises.
~Only visual misinformation is distinct in both groups. Standard optokinetic stimulator (stimulopt) or dynamic visual surround (smart equitest) are used in the control group."
15875605|NCT03838549|Procedure|Prophylactic mastectomy with immediate breast reconstruction|It is an endoscopic approach for prophylactic mastectomy using an axillary single port
15875606|NCT03838536|Dietary Supplement|Whole Egg Powder|Breastfeeding mothers will consume the equivalent of 5 whole eggs per week for 3 months.
15875607|NCT03838536|Dietary Supplement|Egg White Powder|Breastfeeding mothers will consume the equivalent of 5 egg whites per week for 3 months.
15875608|NCT03838523|Other|Open Label Placebo|See group description
15875609|NCT03838510|Behavioral|REBOOT|The brief counseling intervention will utilize Motivational Interviewing and skills-building techniques to modify personal overdose risk behaviors and develop skills as a peer responder for witnessed overdose. The counselor will draw upon themes of safer substance use to address overdose risk behaviors and determine readiness for change in substance use.
15875610|NCT03838497|Biological|Prevenar13|Prevenar13 for both arms
15875611|NCT03838484|Drug|Nicotine Patch, 7 Mg/24 Hr|Nicotine patch, 7 mg/24 hour will be applied to the skin.
15875612|NCT03838484|Drug|Placebo patch|Placebo skin patch will be applied to the skin.
15875613|NCT03838445|Device|V-Wave Interatrial Shunt|The V-Wave Interatrial Shunt System, includes a permanent implant placed during a minimally invasive cardiac catheterization procedure using its dedicated Delivery Catheter. The device is implanted through the fossa ovals and straddles the interatrial septum.
15875614|NCT03838432|Device|Steep Pulse Device|Applying the steep pulse to treat the patients with Prostate cancer
15875615|NCT03838419|Radiation|intraoperative radiotherapy|IORT with 21 Gy prescribed to the 90% isodose line
15875616|NCT03838419|Radiation|whole breast irradiation|hypofractionated WBI Total dose 40.05 Gy (15 x 2.67 Gy)
15876045|NCT03834922|Other|Prospective data collection|No intervention. It's a prospective data collection.
15875617|NCT03838406|Genetic|BRCA 1|The investigators evaluated the incidence of BRCA loss in patients with advanced gastric cancer and observed the treatment outcome and prognosis.
15875618|NCT03838406|Drug|Chemotherapy|"FOLFOX :
~Day 1: Oxaliplatin 85mg/m2 IV + leucovorin 400mg/m2 IV + Fluorouracil (5-FU) 400mg/m2 IV Days 1 and 2: 5-FU 1200mg/m2 IV continuous infusion over 24 hours daily. Repeat cycle every 14 days.
~CAPOX:
~Day 1: Oxaliplatin 130mg/m2 IV Days 1-14: Capecitabine 1000mg/m2 orally twice daily. Repeat cycle every 21 days."
15875619|NCT03838393|Other|multidisciplinary management|pharmacological and non.pharmacological treatment (specially trained nurses, psychologists and physiologists)
15875620|NCT03838380|Other|Smartphone application|Mobile management group participants were given monitoring system devices including a glucometer with Bluetooth connectivity and an accelerometer to detect physical activity level. The mobile phone application specifically designed for this study was installed at enrollment for the mobile management group to collect clinical data and messages from the patients. The application consisted of four sections: clinical data, nutrition and diet, medication, and messaging system and information. Patients allocated to the mobile management group recorded their blood glucose level and diet via the smartphone application, and health care providers regularly scanned clinical data and messages from patients and sent return messages with tailored medical and nutritional guidance.
15875621|NCT03838367|Drug|350 mg leronlimab|leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
15875622|NCT03838367|Drug|525 mg leronlimab|leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
15875623|NCT03838367|Drug|700 mg leronlimab|leronlimab is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
15875624|NCT03838367|Drug|AUC 5 Carboplatin|Carboplatin is an anticancer drug chemotherapy drug.
15875625|NCT03838367|Drug|Maximum Tolerated Dose (MTD) of leronlimab|The decision on the MTD will be made following the results obtained from Phase I studies
15875626|NCT03838354|Drug|Chidamide|Chidamide 2.5 mg po biw, every four weeks for one cycle. It will be given three cycles.
15875627|NCT03838354|Drug|Chidamide|Chidamide 5 mg po biw, every four weeks for one cycle. It will be given three cycles.
15875628|NCT03838341|Device|AtriClip™ LAA Exclusion System|The left atrial appendage is closed from the epicardial side of the heart. Operative access is totally thoracoscopic. The designed and dedicated clip - AtriClip® (AtriCure, Ohio, USA) is introduced to the left pleura through thoracoscopic port.
15875629|NCT03838341|Drug|Oral anticoagulation therapy|Anticoagulation therapy discontinuation - according to the standard of care at the discretion of the Investigator.
15875630|NCT03838328|Drug|Tranexamic Acid|Tranexamic acid will be delivered by loading dose plus maintenance infusion until the end of the operation.
15875631|NCT03838315|Other|Neural Mobilization with Soft Tissue Mobilization|"Cervical Traction for 10mints 7%of body weight with 7 second hold time and 5 second rest time.
~Hot Pack for 10mints. Neural mobilization technique includes Median, Radial and Ulnar nerve mobilization. Frequency for neural mobilization is 3 sets of 10 repetitions for each and duration of 10minute.
~•Post isometric relaxation technique"
15875632|NCT03838315|Other|Neural Mobilization without Soft Tissue Mobilization|"Cervical Traction for 10mints 7%of body weight with 7 second hold time and 5 second rest time.
~Hot Pack
~Neural mobilization technique includes Median, Radial and Ulnar nerve mobilization Frequency for neural mobilization is 3 sets of 10 repetitions for each and duration of 10minute."
15875633|NCT03838302|Procedure|Transvaginal tissue retrieval via a posterior colpotomy|Transvaginal retrieval via a posterior colpotomy for removing tissue by laparoscopic surgery with uterus preservation
15875634|NCT03838302|Procedure|Transabdominal retrieval via trocar|Transabdominal retrieval via trocar for removing tissue by laparoscopic surgery with uterus preservation
15875635|NCT03838289|Radiation|multimodal magnetic resonance imaging or computed tomography|multimodal magnetic resonance imaging including T1 Flair,T2 Flair, magnetic resonance angiography (MRA), perfusion-weighted imaging (PWI), diffusion-weighted imaging (DWI), enhanced gradient echo T2 star weighted angiography (ESWAN); multimodal computed tomography including non-contrast CT, volume perfusion CT
15875636|NCT03838276|Procedure|AL 150 BPL100|Roux-en-Y gastric bypass with 150cm of alimentary limb and 100cm of biliopancreatic limb
15875637|NCT03838276|Procedure|AL 100 BPL 150|Roux-en-Y gastric bypass with 100cm of alimentary limb and 150cm of biliopancreatic limb
15875638|NCT03838263|Drug|Nivolumab|2 nivolumab infusion (240 mg IV) 2 weeks apart (on day 1 and day 15) followed by standard chemoradiation.
15875639|NCT03838263|Radiation|Chemoradiation|Standard of Care chemoradiation for 7 weeks (70 Gray delivered to the tumor by IMRT) with high-dose cisplatin (100mg/m2) at week 1, 4 and 7
15875640|NCT03838250|Biological|Cellgram™ (Bone marrow-derived MSCs)|Approximately 15 to 30 mL of bone marrow is aspirated from the posterior iliac crest of patients under local anesthesia. Approximately 30 days (±7 days) after BM aspiration, the participant will return to the study center for admission and for the infusion Cellgram™ (Bone marrow-derived MSCs).
15875641|NCT03838237|Diagnostic Test|Cardiological evaluation|"Baseline evaluation
~FAbry STabilization indEX (FASTEX)
~12 leads ECG
~Blood samples for microRNA, TnT HS and NT-proBNP dosages
~2D echocardiogram
~Cardio-pulmonary test
~Contrast-enhanced CMR including:
~Cine images
~T2 mapping sequences
~T1 mapping sequences before and 15' after contrast medium administration
~Late Gadolinium Enhancement (LGE) imaging
~Phase contrast images (LVOT, aortic flow)
~Follow up evaluation
~•After 18 months, the same procedures will be repeated"
15875642|NCT03838224|Other|dry needling|"Participants allocated in this group will receive a single session of dry needling of the obliquus capitis inferior. Prior to the intervention, participants will receive information about the procedure and will be free to withdraw. The needle was shown to the participant before the intervention. Participants will be requested to lie in prone on the plinth. Participants' skin will be sterilized with antiseptic spray for the skin. The therapist will clean his hands and use sterilized gloves. The needle will be moved up and down within the muscle, using a fast-in and fast-out technique. Needle insertions will be repeated 12 times."
15875643|NCT03838224|Other|Sham needling|Sham needling has shown to be a valid control method in dry needling research. The procedure in the sham group will be the same as the experimental group to guarantee the participants' blinding. Prior to the intervention, participants will receive information about the procedure and will be free to withdraw. The sham needle (same appearance/material as the true needle) was shown to the participant before the intervention to guarantee the blinding.
15875644|NCT03838211|Device|Anodal tDCS|Anodal transcranial direct current stimulation (tDCS), 9 sessions with 20 minutes stimulation each (current intensity of 1mA)
15875645|NCT03838211|Behavioral|Intensive cognitive training|Intensive cognitive training of a letter memory updating task and a 3-stage Markov decision making task, 9 sessions
15875646|NCT03838198|Behavioral|MI-Enhanced Safety Plan at Hospitalization (1st Component)|"The MI-enhanced safety plan intervention component is delivered during hospitalization and includes an individual and family meetings. The goal of the individual meeting with the adolescent is to develop an individualized safety plan for use during a suicidal crisis. This best practices approach of safety planning is augmented with Motivational Interviewing (MI) as a core strategy to explicitly elicit adolescents' motivation and commitment to behavior change (i.e. use safety plan; adaptive coping), address barriers or ambivalence, and strengthen self-efficacy. The focus of the family meeting, which is similarly guided by MI, is to prepare parents/guardians, with input from the adolescent, for how they may support the adolescent in implementing the individualized safety plan after discharge and on strengthening parents' commitment and self-efficacy."
15875647|NCT03838198|Behavioral|MI-Enhanced Text Boosters (2nd Component)|For participants randomized to receive text boosters, booster text messages will be sent daily for 4 weeks. The messages will be tailored to encourage use of individualized coping strategies identified as part of safety planning at hospitalization and will include additional adaptive coping tools and resources. The text message content and tone will be consistent with principles of MI.
15875648|NCT03838198|Behavioral|MI-Enhanced Booster Call (3rd Component)|The focus of the post-discharge booster phone call with adolescent and with parent, each conducted separately, will be to to further adjust the safety plan to better meet post-discharge needs, to further enhance adolescents' motivation and commitment to use coping strategies, and to further support adolescents' and parents' self-efficacy to manage suicidal crises.
15875649|NCT03838185|Drug|J147|Single oral dose of J147
15875650|NCT03838185|Drug|Placebo|Single oral dose of corn oil
15875651|NCT03838172|Other|Family impact scale|The family Impact Scale (FIS) will be completed by the parents
15875652|NCT03838159|Drug|Paclitaxel|"Paclitaxel must be administered by infusion over 3 hours in dextrose (D5W) or normal saline (NS). The concentration must not exceed 1.2 mg/ml.
~The infusions must be mixed as soon as possible before the start of each infusion since the stability of paclitaxel beyond 24 hours is not known.
~In-line filtration is obligatory since a small number of fibers within the acceptable limits of the USP Particulate Matter Test for LVP have been reported. Cellulose acetate filters of 0.22-micron pore size (such as IVEX II) can be used. The solution that shows excessive particulate matter must be rejected."
15875653|NCT03838159|Drug|Carboplatin|Carboplatin must be administered at the end of the Paclitaxel infusion
15875654|NCT03838159|Drug|Nivolumab|"Nivolumab is a soluble protein consisting of 4 polypeptide chains, which include 2 identical heavy chains and 2 identical light chains.
~The administration of nivolumab infusion must be completed within 24 hours of preparation."
15875655|NCT03838146|Behavioral|Types of Exercise|moderate intensity exercise
15875656|NCT03838133|Drug|TLC590|TLC590, a sustained-release formulation of the local anesthetics with lipid-based excipients
15875657|NCT03838133|Drug|Naropin®|Local infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. 50 mg (0.5%, 10 mL)
15875658|NCT03838133|Drug|Normal Saline|Normal Saline (0.9% sodium chloride, 10ml)
15875659|NCT03838133|Drug|Bupivacaine|Bupivacaine 50 mg (0.5%, 10 mL)
15875661|NCT03838107|Behavioral|observation and measure of trajectory of recovery in CRPS|Child participants enrolled in this study will undergo three sessions, which will include psychosocial measures, brain imaging, and quantitative sensory testing. Parent participants will also complete three sessions, which only include psychosocial measures.
15875662|NCT03838094|Biological|Biodentine|it is a dentin substitute, a new biologically active material facilitates its penetration through opened dentinal tubules to crystallize interlocking with dentin and provide mechanical properties.
15875663|NCT03838094|Biological|MTA|MTA is a powder that consists of fine hydrophilic particles that set in the presence of moisture. MTA consists of tricalcium silicate, tricalcium aluminate, tricalcium oxide and silicate oxide. MTA was considered a remarkable biocompatible material with various clinical applications that include surgical and non-surgical applications such as pulp capping
15875664|NCT03838081|Behavioral|Spielberger State Anxiety Inventory (STAI-S),|STAI is one of the most frequently used scales in anxiety research, although it is not a specific scale for dental anxiety
15875665|NCT03838081|Behavioral|Dental Fear Scale (DFS)|DFS is a scale developed by Kleinknecht used to determine dental fear in different dimensions. This is a Likert-type scale with a score of 1-5. It has 20 items. It examines the level of fear in terms of dentist avoidance, somatic symptoms of fear, and fear of various applications in dentistry practice
15875666|NCT03838081|Behavioral|Modified Dental Anxiety Scale (MDAS)|MDAS was developed by Humphris et al. by adding a question related to injection. The scale consists of five-point Likert-type rating with five options. The scoring in this scale varies between 5 and 25
15875667|NCT03838081|Behavioral|Visual Analog Scale (VAS)|"VAS is ideal for evaluating situations that cannot be measured using digital and oral information. In the present study, a scale comprising 100-mm closed-end line was used to measure the anxiety level. One end of the scale was labeled as no anxiety and the other end as maximum anxiety imaginable"
15875668|NCT03838068|Biological|Biodentine|Biodentine is considered a calcium silicate cement
15875669|NCT03838068|Biological|mineral trioxide aggregate|calcium based silicate cement
15875670|NCT03838068|Procedure|cervical pulpotomy|coronal pulp tissue was removed till the orifice
15875671|NCT03838068|Drug|Local Anesthetics Procaine|40 mg/0.01 mg/ml contains sodium metabisulfite and sodium and articaine as an active substance
15875672|NCT03838055|Procedure|Injection of tracer ( ICG) and detection of sentinel lymph nodes|Pelvic SLN's defined by ICG injected cervically
15875673|NCT03838042|Drug|Nivolumab and Entinostat|Patients entering phase I will receive one week entinostat without nivolumab (priming phase) before receiving the combination treatment of nivolumab and entinostat.
15875674|NCT03838029|Drug|Propranolol and etodolac|A perioperative combined drug regimen
15875675|NCT03838029|Other|Placebo|Placebo
15875676|NCT03838016|Behavioral|Babble Boot Camp|The Babble Boot Camp is an experimental study to investigate whether earliest and proactive activities and routines can positively influence the speech and language development of children who were diagnosed with classic galactosemia at birth. A speech-language pathologists implements the intervention by teaching parents to foster and expand earliest signals of communication, prespeech activities such as coo and babble, vocabulary growth, sentence complexity, and use of language to communicate. Examples are intentional eye contact, reinforcing babble with rewarding play activities, and repeating a child's rudimentary sentence with slight expansions to scaffold longer sentences.
15875677|NCT03838003|Procedure|ERIC protocol|ERIC protocol is an aerobic exercise protocol with 5 levels of intensity
15875678|NCT03837990|Drug|Helicobacter Pylori eradication therapy|Eradication therapy includes the administration of a proton pump inhibitor (PPI) and antibiotics. Triple therapy with a PPI (lansoprazole or esomeprazole), clarithromycin, and amoxicillin is the first-line regimen. Quadruple therapy with a PPI, bismuth, metronidazole, and tetracyclin is the second-line therapy.
15875679|NCT03837977|Drug|Liposomal Irinotecan|Arm I
15875680|NCT03837977|Drug|Fluorouracil|Arm I
15875681|NCT03837977|Drug|Folinic Acid|Arm I
15875682|NCT03837977|Drug|Docetaxel|Arm II
15875683|NCT03837964|Drug|BI 1291583|Tablet
15875684|NCT03837951|Other|Figure-of-eight tape measure measurements on both hands|Tape measure is wrapped around the wrist and hand and a measurement reading is taken. this is repeated 3 times.
15875685|NCT03837951|Other|Volumeter measurements|Volumeter measurements to uninjured participants had 3 measurements taken of each hand.
15875686|NCT03837938|Drug|Levopront® syrup 30 mg/5 ml|The first study drug administration will be performed at the clinical site on the day of randomization; the last study drug administration will be performed in the evening before Day 8 (±1).
15875687|NCT03837938|Drug|Libexin®|The first study drug administration will be performed at the clinical site on the day of randomization; the last study drug administration will be performed in the evening before Day 8 (±1).
15875688|NCT03837925|Drug|Atorvastatin 40mg Tablet|Patient participation for 6 weeks of treatment
15875689|NCT03837925|Drug|Placebo comparator|Patient participation for 6 weeks of treatment
15875690|NCT03837912|Behavioral|Patient reported safety experiences fed back to PC providers|The intervention will involve three key stages: a) Measurement: Patients will be invited to complete the Patient Reported Experiences and Outcomes of Safety in Primary Care (PREOS-PC) questionnaire using a tablet-computer. b) Feedback: Using a bespoke online tool, the information will be processed and presented to each centre in the form of a Feedback Report, which will offer comparisons with other centres along with a set of recommendations for addressing the problems identified. c) Action planning and change: centres will form an Action Planning Team, which will be responsible for analyzing the report, considering which area(s) should be improved, and developing, implementing and monitoring an action plan to address the safety problems identified.
15875692|NCT03837886|Dietary Supplement|Sodium bicarbonate|The subjects should ingest 0.3g.kg of sodium bicarbonate 90 minutes before the beginning of the protocol task.
15875693|NCT03837886|Dietary Supplement|Calcium carbonate|The subjects should receive gelatinous capsules containing 0.3 g.kg -1 of Calcium Carbonate
15875694|NCT03837873|Drug|Rituximab|rituximab 750mg/m2 i.v. on day 0
15875695|NCT03837873|Drug|Etoposide|50mg/m2, continuous i.v. on day 1-4
15875696|NCT03837873|Drug|Vincristine|0.4mg/m2, continuous i.v. on day 1-4
15875697|NCT03837873|Drug|Doxorubicin|10mg/m2, continuous i.v. on day 1-4
15875698|NCT03837873|Drug|Dexamethasone|30mg/day, i.v. on day 1-5 for R-DA-EDOCH regimen; 40mg/day, i.v. on day 1-4 for R(2)-DHAP regimen
15875699|NCT03837873|Drug|Cyclophosphamide|750mg/m2, i.v. on day5
15875700|NCT03837873|Drug|Lenalidomide|25mg/day, p.o. on day 0-9
15875701|NCT03837873|Drug|Cisplatin|100mg/m2 continuous i.v. on day 1
15875702|NCT03837873|Drug|Cytarabine|2g/m2 q12h, i.v. on day 2
15875706|NCT03837847|Behavioral|Health Coaching Calls|12 weekly health coaching calls
15875707|NCT03837847|Behavioral|Wait list control|after being 12 week in the usual care arm , patient will compassionately be offered the health coaching intervention
15875708|NCT03837834|Other|Functional Electrical Stimulation Leg Cycling Exercise|FES- leg cycling for 45 minutes (3 min warm up + 40 min HIIT + 2 min cooldown). The FES will be applied via surface electrodes and the stimulation intensity based on your tolerance level.
15875709|NCT03837821|Drug|Abemaciclib|Abemaciclib 200 mg oral, every 12 hours
15875710|NCT03837808|Drug|Nimotuzumab|nimotuzumab 200mg/week in concurrent with IMRT, d1,d8,d15,d22,d29,d36 of RT
15875711|NCT03837808|Drug|Cisplatin|cisplatin 40mg/m2/week in concurrent with IMRT, d1,d8,d15,d22,d29,d36 of RT
15875712|NCT03837795|Device|Neurofeedback treatment|A treatment that developed to train adults with sensory modulation disorder by applying EEG (Curry 7 EEG system, Neuroscan-Compumedics). This treatment will aim to normalize the Alpha power (amplitude).
15875713|NCT03837782|Procedure|minimally invasive surgery|Each participating site required accreditation by the trial management committee to ensure proper surgical technique during minimally invasive surgery. No individual surgeons performed only the open approach or only the minimally invasive approach. The committee members reviewed the patients' outcomes and the videos to ensure the adequacy of the surgeon's technique.
15876046|NCT03834909|Drug|Standard dose Truvada®|TDF/FTC fixed dose combination, 300 mg TDF/200 mg FTC, one tablet each day
15875714|NCT03837769|Device|Aktiia OBPM PulseWatch wrist device|The optical signals at the wrist are recorded non-invasively. The BP measurements are further determined from these optical signals and are compared to the reference BP readings.
15875715|NCT03837756|Drug|Saline|Placebo
15875716|NCT03837756|Drug|Lefitolimod|A TLR9 agonist administered s.c. once weekly for 8 weeks.
15875717|NCT03837756|Drug|3BNC117 and 10-1074|Broadly neutralizing antibodies against HIV env administered two times with a 3 week interval.
15875718|NCT03837743|Drug|DUR-928 Topical Solution|Topical solution containing active drug
15875719|NCT03837743|Drug|Vehicle Topical Solution|Topical solution containing no active drug
15875720|NCT03837717|Behavioral|Holding|Mothers will be assisted with holding their infants (and the cooling blanket) for a single 30-minute period, with the use of a thin foam barrier for thermal protection. Mothers and infants will not be skin-to-skin.
15875721|NCT03837717|Other|Saliva collection|Saliva will be collected from infants (via syringe suction) and mothers (via passive drool), and tested for levels of cortisol and oxytocin
15875722|NCT03837717|Behavioral|No Holding|Saliva will be collected from Mothers and infants, and vital sign information will be collected from infants in the same manner as the Holding intervention, with the exception of having mother's hold their infants.
15875723|NCT03837704|Other|IQOS|AAA patients will switch from cigarette smoking to ad libitum IQOS use, with no flavor variant restrictions.
15875724|NCT03837704|Other|Cigarette|AAA patients will continue to smoke their cigarettes ad libitum, with no brand restrictions.
15875725|NCT03837704|Other|Smoking Cessation|AAA patients who have completely quit smoking will continue to remain abstinent from smoking cigarettes or using any tobacco or nicotine-containing product(s)
15875726|NCT03837691|Device|Placement of Snowshoe Suture Anchors|Snowshoe suture anchors from g-Cath EZ Delivery Catheters are placed in the stomach with the aid of a Transport, g-Lix and g-Prox device
15875727|NCT03837691|Behavioral|Moderate Intensity Diet & Exercise Program|After placement of the snowshoe suture anchors in the stomach, subjects are asked to follow a moderate intensity diet and exercise program
15875728|NCT03837665|Biological|Platelet Rich Plasma|Platelet Rich Plasma (PRP) is blood plasma that has been enriched with platelets.
15875729|NCT03837652|Other|Use of bone-borne palatal expander & maxillary osteotomy|Application of bone-borne palatal expander in conjunction with maxillary osteotomy for expansion of constricted maxillae
15875730|NCT03837639|Other|Arm ergometer|Arm-crank exercise group will be performed twice a week for 12 weeks. In the first weeks of training, each session will consist of 15 bouts, two active minutes and two minutes of passive interval, consisting of 60 minutes of session (30 minutes of active exercise). After the first three weeks of training, the exercise time will progressively increase by one minute every 3 weeks and the recovery period will be decreased, completing, at the end, a maximum volume of 10 bouts of five minutes of exercise and one minute of passive interval. The intensity of the exercise will be determined by the load equivalent to the range of 13 - 15 of The Borg Rating of Perceived Exertion, considered as somewhat hard to hard
15875731|NCT03837639|Other|Treadmill ergometer|Walking exercise group will be performed twice a week for 12 weeks. In the first weeks of training, each session will consist of 15 bouts, two active minutes and two minutes of passive interval, consisting of 60 minutes of session (30 minutes of active exercise). After the first three weeks of training, the exercise time will progressively increase by one minute every 3 weeks and the recovery period will be decreased, completing, at the end, a maximum volume of 10 bouts of five minutes of exercise and one minute of passive interval. The intensity of the exercise will be determined by the load equivalent to the range of 13 - 15 of The Borg Rating of Perceived Exertion, considered as somewhat hard to hard.
15875732|NCT03837639|Other|Control group|Patients randomized to control group will attend to meetings with the researcher team twice a week during the 12 weeks. At these meetings, patients will perform manual tasks, with or without the use of artistic materials, cultural programs, cooking classes and home care, without any exercise component. This CG practice will be performed in order to minimize the effects of the patient's bi- weekly commitment and displacement to the training site, to minimize the influence of the patient- researcher contact and also minimize the convivial effect among the patients themselves, which will occur in the other two groups.
15875733|NCT03837626|Drug|Placebo - Cap|6 months of 1 pill a day
15875734|NCT03837626|Drug|Amiloride Pill|Max dose of 5 mg a day for 6 months
15875735|NCT03837613|Procedure|tumor resection and neck dissection|Surgical removal of the tumor with adequate safety margins. In addition to neck dissection to dissect the cervical lymph nodes.
15875736|NCT03837561|Drug|Cunox|Inject 4 Units (0.1 mL) of reconstituted investigational product or the comparator intramuscularly into each of 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle for a total dose of 20 Units.
15875737|NCT03837561|Drug|Botox|Inject 4 Units (0.1 mL) of reconstituted investigational product or the comparator intramuscularly into each of 5 sites, 2 in each corrugator muscle and 1 in the procerus muscle for a total dose of 20 Units.
15875738|NCT03837548|Other|Training with Neurofeedback|Neurofeedback the brain activities by Magnetoencephalography
15875739|NCT03837548|Other|The other Training with Neurofeedback|Neurofeedback the brain activities by Magnetoencephalography
15875740|NCT03837535|Procedure|Surgery|Neuro, Lung/thorax, GI, Gynecologic, Urologic, Orthopedic, Vascular surgery
15875741|NCT03837522|Diagnostic Test|Procurement Biopsy: Frozen section|Frozen sections are prepared by freezing and slicing the tissue sample; importantly, they can be done in about 15 to 20 minutes. Frozen sections are done when an immediate answer is needed, but do not provide optimal quality.
15875742|NCT03837522|Diagnostic Test|Procurement Biopsy: Permanent section|Permanent sections are prepared by placing the tissue in fixative (usually formalin) to preserve the tissue, processing it through additional solutions, and then placing it in paraffin wax. After the wax has hardened, the tissue is cut into very thin slices, which are placed on slides and stained. The process normally takes several days.
15875743|NCT03837509|Drug|INCB001158|Phase 1: INCB001158 administered orally twice daily at the protocol-defined starting dose, with dose escalation/de-escalation based on protocol-defined toxicity criteria to determine the maximum tolerated dose. INCB001158 is administered in combination with daratumumab SC. Phase 2: INCB001158 administered orally at the recommended dose from Phase 1 either as a monotherapy or in combination with daratumumab SC.
15876815|NCT03829319|Drug|Placebo matching lenvatinib|Oral capsule once daily
15875744|NCT03837509|Biological|Daratumumab SC|Daratumumab 1800 mg co-formulated with rHuPH20 (2000 U/mL) and administered subcutaneously once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and then once every 4 weeks. Daratumumab will be administered either as monotherapy or in combination with INCB001158.
15875747|NCT03837483|Genetic|OTL-103|Autologous hematopoietic stem cells collected from mobilized peripheral blood transduced ex vivo with a lentiviral vector encoding the WAS cDNA
15875748|NCT03837470|Drug|0.9% Sodium Chloride|Intravenous infusion of 0.25ml/kg/min of 0.9% sodium chloride intravenously for a total of 60 minutes
15875749|NCT03837470|Drug|Furosemide 40 mg|Bolus intravenous injection of 40 mg furosemide
15875750|NCT03837457|Drug|Cobomarsen|At least weekly intravenous infusions of cobomarsen (282 mg) throughout study treatment period
15875751|NCT03837431|Diagnostic Test|Skin slit|Skin slit microscopy, RDT and PCR
15875752|NCT03837431|Diagnostic Test|Dental broach|Dental broach RDT and PCR
15875753|NCT03837431|Diagnostic Test|Tape disc|Tape disc PCR
15875754|NCT03837405|Behavioral|Carbohydrate-restricted diet|Education for carbohydrate-restricted diet
15875755|NCT03837405|Behavioral|Mindfuless|Mindful eating app use plus group sessions to learn mindfulness
15875756|NCT03837392|Diagnostic Test|Baseline Assessment (18-26 weeks pregnant)|At baseline, participants will complete several interviews and questionnaires online and via phone to determine psychological history, current functioning, history of trauma, coping styles, and demographic variables.
15875757|NCT03837392|Behavioral|Online Intervention and Phone Coaching Interventions|ACT is a cognitive-behavioral therapy that seeks to promote psychological flexibility. The active comparator is the Supportive Control. Two phone coaching sessions will occur 2- and 4-weeks post-intervention in both conditions.
15875758|NCT03837392|Diagnostic Test|Follow Up Assessments: 34-36 weeks pregnant and 4-week postpartum|The follow-up assessments at 34-36 weeks pregnancy and 4-weeks postpartum will be completed via REDCap, an online secure survey platform in order to reduce participant burden.
15875759|NCT03837392|Diagnostic Test|Follow Up Assessments: 8 weeks postpartum|The follow-up assessment at 8-weeks postpartum will be completed via phone.
15875760|NCT03837379|Behavioral|Treatment as Usual|Participants in the Treatment As Usual condition will receive educational material on quitting smoking. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment.
15875761|NCT03837379|Combination Product|Goal2Quit + NRT Sampling|"Participants in the Goal2Quit + NRT Sampling condition will receive a download code to download the Goal2Quit mobile application. Goal2Quit is a mobile app for cigarette smokers with elevated symptoms of depression. Within the app, users identify values, create activities, schedule activities, rate mood daily, and track cigarette smoking. Participants in Group B will also receive a two-week starter kit sample of nicotine replacement therapy (NRT; 14mg patch and 4mg lozenge). Participants will be asked to utilize Goal2Quit regularly, at least once per day, as well as the NRT sample in an attempt to quit smoking. Participants will be asked to complete questionnaire measures weekly for 8 weeks, with a final follow-up questionnaire at 12 weeks following study enrollment."
15875762|NCT03837366|Behavioral|Activity tracker and health coaching|Use of an activity tracker alone or in combination with health coaching on physical activity behaviors.
15875763|NCT03837353|Drug|DKN-01 300 mg|DKN-01 300 mg intravenously (IV)
15875764|NCT03837353|Drug|DKN-01 600 mg|DKN-01 600 mg IV
15875765|NCT03837353|Drug|Docetaxel 75 mg/m2|Docetaxel 75 mg/m2, Day 1 of every 3 Weeks
15875766|NCT03837353|Drug|DKN-01 150 mg|DKN-01 150 mg intravenously (IV)
15875767|NCT03837340|Other|CMHT|Community mental health teams (CMHTs) delivering evidence-based interventions to people with SMI, inspired by the Flexible Assertive Community Treatment (FACT) service delivery model.
15875768|NCT03837340|Other|CAU|Care as usual (CAU) usually consisting of inpatient psychiatric care or outpatient care prescribing medication.
15875769|NCT03837314|Device|"Bioinduction Picostim Deep Brain Stimulation system"|Neurostimulation of the subthalamic nucleus region.
15875770|NCT03837301|Procedure|NESS-EFTR with sentinel lymph node navigation|Non-exposure Simple Suturing Endoscopic Full-Thickness Resection with sentinel lymph node navigation (basin dissection) for early gastric cancer patients
15875771|NCT03837288|Procedure|Cerclage|Cervical cerclage under effect of spinal anaesthesia
15875772|NCT03837275|Procedure|Sinus Floor Elevation Between Hydrodynamic Ultrasonic Maxillary Sinus Floor Elevation Technique|Sinus Floor Elevation Between Hydrodynamic Ultrasonic Maxillary Sinus Floor Elevation Technique (Intralift Technique) and implant placement
15875773|NCT03837275|Procedure|closed maxillary sinus lift|transdcrestal sinus lift and immediate implant placment
15875774|NCT03837262|Combination Product|Flash Glucose Monitoring and structured education|A feasibility study assessing the use of flash glucose sensing technology with structured education to improve glycemic outcomes in T2D adults and children
15875775|NCT03837249|Device|Personal Sleep Monitoring|Wearable Sleep Self-Monitoring Device (Actigraphy)
15875776|NCT03837236|Other|Study group|Evaluation parameters will be performed to the patients. Physical activity level, exercise barriers, disease activity, fatigue, depression, pain, sleep disorders, aerobic capacity and quality of life will be assessed using International Physical Activity Questionnaire-Short Form (IPAQ),Exercise Benefits/Barriers Scale, Behçet Disease Current Activity Form (BDCAF), Fatigue Severity Scale (FSS), Beck Depression Inventory (BDI), McGill Pain Questionnaire- Short Form (MPQ-SF), Pittsburgh Sleep Quality Index, 6 minute walk test and Behçet's Disease Quality of Life Questionnaire, respectively.
15875777|NCT03837223|Drug|GnRH agonist|In High Responder patients (HR) (more than 18 follicles with diameter ≥ 12mm at ovulation induction), the trigger was obtained with triptorelin 0.2 mg sc. In this cohort if less of 18 oocytes were retrieved, patients were considered at intermediate risk of OHSS and fresh transfer was performed. An adequate support of the luteal phase was initiated: HCG 1500 IU / sc the day of the pick up + estradiol 4 mg + vaginal progesterone 400 mg daily (Rescue protocol).
15875778|NCT03837210|Drug|Pylorin|Poly Herbal formulation
15875779|NCT03837197|Device|Kidney-Hypothermic oxygenated|"Kidney perfusion will be performed through the renal artery at 25-30 mmHg pressure.
~Flow, pressure and temperature will be monitored and registered on a Universal Serial Bus (USB) memory system during organ perfusion. Gas analysis of the effluent perfusate will be accomplished at the start of perfusion (T0) then every 30 minutes. Two perfusate samples will be collected at the beginning and at the end of perfusion to rule out bacterial or fungal contamination.
~HOPE will start by flushing the organ at low flow values (20 ml/min) with new oxygenated perfusion fluid during back-table preparation. Organ will be treated with continuous HOPE until transplant. Organ perfusion will be continuously monitored. Minimal perfusion time will be 2 hours for kidneys."
15875780|NCT03837197|Device|Liver-Hypothermic oxygenated|"Liver perfusion will be performed through the portal vein at a 5 mmHg pressure.
~Flow, pressure and temperature will be monitored and registered on a Universal Serial Bus (USB) memory system during organ perfusion. Gas analysis of the effluent perfusate will be accomplished at the start of perfusion (T0) then every 30 minutes. Two perfusate samples will be collected at the beginning and at the end of perfusion to rule out bacterial or fungal contamination.
~HOPE will start by flushing the organ at low flow values (30 ml/min) with new oxygenated perfusion fluid during back-table preparation. Organ will be treated with continuous HOPE until transplant. Organ perfusion will be continuously monitored. Minimal perfusion time will be 1 hour for livers."
15875781|NCT03837184|Biological|Onasemnogene Abeparvovec-xioi|Onasemnogene abeparvovec-xioi is a non-replicating recombinant adeno-associated virus serotype 9 (AAV9) containing the human survival motor neuron (SMN) gene under the control of the cytomegalovirus (CMV) enhancer/chicken β-actin-hybrid promoter (CB). Onasemnogene abeparvovec-xioi will be administered as a one-time intravenous infusion over approximately 60 minutes. Dosage will be determined by the participants weight.
15875782|NCT03837171|Biological|Liberal Red blood cell transfusion|"Hemoglobin level will be maintained above 9 g/dL (liberal strategy) for the first 48 hours following randomization. After 48 hours, indications of RBC transfusions will be at the discretion of attending physicians in patients with persistent circulatory failure.
~After resolution of acute circulatory failure, a 7 g/dL transfusion threshold will be recommended regardless of the allocation arm. In case of subsequent episodes of septic shock, the transfusion strategy will be at the discretion of attending physicians"
15875783|NCT03837171|Biological|Restrictive Red blood cell transfusion|Hemoglobin level will be maintained above 7 g/dL (restrictive strategy) during all the stay in ICU
15875784|NCT03837158|Procedure|early loading|two TiZr implants on SLA surface
15875785|NCT03837158|Procedure|immediate loading|four TiZr implants on SLA surface
15875786|NCT03837132|Behavioral|Palliative care assessment|Patients with advanced pancreatic cancer will have regular palliative care assessment with palliative care team
15875787|NCT03837119|Other|pregnancy outcome|descriptive statistics of variables
15875788|NCT03837106|Other|Rehabilitation program|3-month rehabilitation program comprising exercise and education specific to musicians. The program will be supported by an online platform containing more than 50 exercise videos, narrated powerpoint presentations, informative videos, quizzes, and forums for communicating with a physiotherapist and for organizing group exercise sessions.
15875789|NCT03837093|Drug|ILT101|Subcutaneous injections starting with induction course with once-daily administration for 5 consecutive days, followed by maintenance course with once every weeks administration during three weeks
15875790|NCT03837093|Drug|Placebo|Subcutaneous injections starting with induction course with once-daily administration for 5 consecutive days, followed by maintenance course with once every weeks administration during three weeks
15875791|NCT03837080|Other|Nutrition Education|Every patient will receive one individual and two group counselings on specific nutrition-related recommendations for chronic pain patients.
15875792|NCT03837054|Biological|Blood collection and Micronuclei assay on binucleate lymphocytes in culture|"The activity of the oncology Department of the North Hospital ensures the quick and easy recruitment of 30 patients over the 10-month inclusion period. The collection of samples will be done in a forward-looking manner during chemotherapy and at different times. The patients will have 4 blood samples of 10 mL carried out during their chemotherapy with a sampling at T0 (before the initiation of chemotherapy), then to T1 (after the first 3 cures), to T2 (after the 6th cure) and to T3 is 5 weeks after the end of the chemo And before the onset of radiation therapy. The samples will be carried out within the Medical Oncology Department of the hospital Nord of Marseille.
~We will also perform micronuclei testing on Binucleate lymphocytes in culture. The lymphocyte Micronuclei test reveals structure and number chromosomal damage and allows to reveal clastogenic or eugènes exposures."
15875793|NCT03837041|Other|Reconditioning Proprioception|Proprioceptive training using Delos Postural Proprioceptive System
15875794|NCT03837028|Other|FSFI|Sexual dysfunction was assessed via the self-administered Female Sexual Function Index Questionnaire which was adapted to the Turkish population. This is a 19-item questionnaire that covers six domains: desire; arousal, lubrication, orgasm, satisfaction, and pain. The full score is obtained by adding the six domain scores. FSFI scores range from 2.0 to 36.0, with higher scores indicating better sexual functioning.
15875795|NCT03837015|Drug|Estring Vaginal Ring|Estradiol vaginal ring, containing 2mg estradiol designed for slow release over 30 days
15875796|NCT03837015|Other|RepHresh Pro-B|Probiotic supplement containing 2.5 billion CFU of Lactobacilli reuteri RC-14 and Lactobacilli rhamnosus GR-1, administered vaginally or orally
15875797|NCT03837002|Other|foot care protocol|foot assesment, foot care, foot care education
15875798|NCT03836989|Device|Electrical stimulation device (tens unit)|An electrical stimulation device with adjustable voltage. Useful for both Sensory and Subsensory
15875799|NCT03836976|Other|Auditory gamma sensory stimulation|"Gamma-conditioning stimulation will be
~administered in 2 blocks of 3 min each. During each block, participants will be presented with a continuous
~tone at the CF (500 or 1200 Hz) that will be amplitude modulated at 40 H"
15875863|NCT03836456|Behavioral|Health Enhancement Program|This is a validated active control developed to serve as a control for mindfulness-based studies.
15875806|NCT03836937|Drug|Obeticholic acid|Farnesoid X receptor ligand which is a semi synthetic bile acid analogue
15875807|NCT03836924|Drug|Perampanel|Perampanel tablets.
15875808|NCT03836911|Other|serious game|Effect of serious game on elderly in comparison of the physical activity adapted meeting
15875809|NCT03836911|Other|classic program|Effect of serious game on elderly in comparison of the physical activity adapted meeting
15875810|NCT03836898|Device|Presbyopic posterior chamber phakic intraocular lens IPCL|Presbyopic posterior chamber phakic intraocular lens IPCL (EyeolUK, United Kingdom) has a refractive optic and diffractive trifocal pattern on its anterior optical surface to correct both distance and near refractive errors. Presbyopic addition is manufactured in a range of +1.0 to + 4.0 diopters (D) in 0.5 D steps.
15875811|NCT03836885|Drug|Apremilast|Apremilast tablets. Titration will occur in the initial five days of treatment as per dosing in psoriasis as follows: Day 1: 10 mg; Day 2: 20 mg; Day 3: 30 mg; Day 4: 40 mg; Day 5: 50 mg. Day 6 and thereafter patients will be dosed at 60 mg for a total of 12 weeks.
15875812|NCT03836885|Drug|Placebo|Placebo Oral tablets. Patients randomized to the control arm will receive color, taste, shape and odour matched oral placebo. The number of tablets and the days taken is analogous to the intervention arm had they been randomized to the intervention arm.
15875813|NCT03836872|Device|Acupuncture|Patients in the experimental group will receive, in addition to standard care, a standardised 30-minute acupuncture session needling specific acupoints although there will be flexibility in case some points cannot be punctured (e. g. in case of lymphoedema), and alternative points (as in routine practice) may be selected by the acupuncture practitioner using their discretion to maintain an equal dose of treatment to all patients. Bilateral acupoints will be stimulated. These points will include Waiguan (SJ5), Jianjing (GB21), Yanglingquan (GB34), Hegu (LI4), Jiexi (ST41) and Taixi (K3). In addition, joint specific acupoints will also be used, depending on where the joint symptoms are present.
15875814|NCT03836859|Drug|rhNGF 20μg/mL|"Study Eye (For subjects randomized to rhNGF group) Day 1: One drop instilled into study eye (35 μL, corresponding to 0.70 μg of rhNGF).
~Day 2, 3, 4, 5, 6: One drop six times a day (every 2h) into study eye (210 μL, corresponding to 4.20 μg of rhNGF).
~Total dose in the study eye will be 31 drops (1085 μL, equivalent to 21.7 μg rhNGF) over 6 days."
15875815|NCT03836859|Other|Placebo|Vehicle: formulation containing L-methionine as excipient.
15875816|NCT03836846|Behavioral|CBT Mobile App|TAU and the additional treatment of a Mental Health App (What's Up?). This app will be used to guide adolescents through cognitive behavioral therapy and acceptance commitment therapy techniques, as well as to assist in developing coping mechanisms to prevent readmission.
15875817|NCT03836846|Behavioral|Treatment as usual|TAU as per standard of care
15875818|NCT03836833|Drug|ABC/3TC/LPV/r granules (30/15/40/10 mgs)|"This is a fixed dose combination. Each capsule contains Lopinavir (40mg), Ritonavir (10mg), Abacavir (30mg) and Lamivudine (15mg) in granules formulation.
~Dosage according to patient's weight:
~Between 3 and 5.9kg: 2 capsules twice a day Between 6 and 9.9kg: 3 capsules twice a day Between 10 and 13.9kg: 4 capsules twice a day Between 14 and 19.9kg: 5 capsules twice a day Between 20 and 24.9kg: 6 capsules twice a day"
15875819|NCT03836833|Drug|LPV/r Pellets (40/10mgs) plus ABC/3TC (60/30mgs)|"Lopinavir/Ritonavir (40/10mg pellets) plus dual Abacavir/Lamivudine (60/30mg dispersible tablets)
~Dosage according to patient's weight:
~LPV/r Pellets:
~Between 3 and 5.9kg: 2 capsules twice a day Between 6 and 9.9kg: 3 capsules twice a day Between 10 and 13.9kg: 4 capsules twice a day Between 14 and 19.9kg: 5 capsules twice a day Between 20 and 24.9kg: 6 capsules twice a day
~ABC/3TC:
~Between 3 and 5.9kg: 1 tablet twice a day Between 6 and 9.9kg: 1.5 tablets twice a day Between 10 and 13.9kg: 2 tablets twice a day Between 14 and 19.9kg: 2.5 tablets twice a day Between 20 and 24.9kg: 3 tablets twice a day"
15875820|NCT03836820|Other|Clinical pilates exercise|Clinical pilates exercises will be performed three days in a week. Treatment will continue an hour in per session for 8 weeks.
15875821|NCT03836820|Other|Aerobic exercise|Progressive aerobic walking exercise will be performed three days in a week. Exercise intensity will be 50- 80% of maximal heart rate and exercises will be performed 45 minutes in per session for 8 weeks.
15875822|NCT03836820|Other|Clinical Pilates and Aerobic Exercise|Both clinical pilates exercises and progressive aerobic walking exercises will be performed three days in a week for 8 weeks.
15875823|NCT03836807|Drug|Ketoprofen|40 mg KLS granules (corresponding to 25 mg ketoprofen)
15875824|NCT03836807|Other|Placebo|0 mg KLS granules
15875825|NCT03836781|Drug|Ketorolac|Ketorolac 3% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe
15875826|NCT03836781|Drug|Chlorhexidine 2%|Chlorhexidine 2% topical subgingival irrigation was put into the periodontal pocket using an insulin syringe
15875827|NCT03836768|Drug|DTRMWXHS-12|DTRMWXHS-12 capsules: 150 mg, 300 mg
15875828|NCT03836755|Diagnostic Test|Metacos|Evaluation of stability of implant by RSA technique
15875829|NCT03836742|Procedure|Hemofiltration with regional citrate anticoagulation|To reduce risk of metabolic alkalosis during hemofiltration treatment, ACD-A citrate solution was proposed instead of most commonly used trisodium citrate solution and relatively low target citrate concentration (2.8 mmol/L) was adopted. In case of pH increase above 7.5 or bicarbonate concentration above 40 mmol/L filtrate flow was decreased from initial 35 ml/kg/hour down to 25 ml/kg/hour which reduced bicarbonate delivery by 25%. If metabolic alkalosis persisted, the second step involved reduction of blood flow from initial 5 times down to 4 times filtrate flow, which reduced citrate flow by the same factor.
15888864|NCT03736616|Biological|Rituximab|Anti-CD20 mAb
15875830|NCT03836729|Drug|Tenofovir alafenamide/emtricitabine|TAF/FTC will be available as 25/200 milligrams (mg) tablet. Subjects will be administered TAF/FTC 25/200 mg QD via the oral route.
15875831|NCT03836729|Drug|GSK3640254|GSK3640254 will be available as 100 mg capsule. Subjects will be administered GSK3640254 200 mg capsule QD via the oral route.
15875832|NCT03836716|Drug|Arimoclomol|Active treatment
15875833|NCT03836703|Drug|Feroglobin single daily use|Feroglobin single daily use ( IRON FUM&POLYSAC#1/FA/MV NO.18 162 Mg-115.2 Mg (106 Mg Iron)-1 Mg ORAL CAPSULE ) to prevent iron deficiency anemia during pregnancy from 14 weeks gestation going on.
15875834|NCT03836703|Drug|Feroglobin twice daily dose|Feroglobin twice daily dose ( IRON FUM&POLYSAC#1/FA/MV NO.18 162 Mg-115.2 Mg (106 Mg Iron)-1 Mg ORAL CAPSULE ) to prevent iron deficiency anemia during pregnancy from 14 weeks gestation going on.
15875835|NCT03836690|Biological|CD62L- Tem|Donor memory T cells that have been depleted of CD62L+
15875836|NCT03836677|Combination Product|BGF|Treatment with Budesonide/Glycopyrronium/FormoterolFumarate
15875837|NCT03836677|Combination Product|GFF|Treatment with Glycopyrronium/Formoterol Fumarate
15875838|NCT03836664|Drug|Timolol|Timolol is a clear solution supplied in a plastic ophthalmic dispenser.
15875839|NCT03836664|Drug|Placebo|Placebo is normal saline solution that will be supplied in container matched to Timolol container.
15875840|NCT03836651|Other|Dietary Antioxidant (V8® Low Sodium 100% vegetable juice)|Following completion of baseline data collection, participants will be randomized to one of two groups. Participants randomized to the intervention group will receive a month's supply of the V8® 100% Low-Sodium Vegetable juice as the dietary antioxidant intervention. Participants will be asked to drink one V8® juice each day for 30 days. Each V8® juice can is 11.5 ounces and can be consumed in divided amounts or all at once. The average daily intake of lycopene is estimated to be 5mg, one can of V8 juice provides 24 mg of lycopene. Thirty days duration for the intervention of V8® juice is based on previous data that indicates plasma antioxidant concentrations rise significantly within a two-week period and a plateau effect is reached within 4 weeks.
15875841|NCT03836651|Other|Control group|The control group will continue to be medically managed by their health care provider as usual. The control group will have the same visit and call schedule as the intervention group.
15875842|NCT03836638|Drug|30 Units of botulinum toxin|30 Units of botulinum toxin to upper face
15875843|NCT03836638|Drug|50 Units of botulinum toxin|50 Units of botulinum toxin to upper face
15875844|NCT03836625|Other|CareConekta|CareConekta is a smartphone app that uses the phone's GPS to prospectively characterize mobility and allow for intervening in real-time. CareConekta uses the phone's built-in GPS system to record location coordinates.
15875845|NCT03836612|Other|No intervention|Observation of routine clinical practice
15875846|NCT03836599|Drug|Verinurad|Participants will receive verinurad 24 mg in cohort 1 and 12 mg in cohort 2 once daily.
15875847|NCT03836599|Drug|Allopurinol|Participants will receive allopurinol 300 mg once daily.
15875848|NCT03836599|Drug|Placebo|During Run-in Period, participants in cohort 1 will receive placebo matching allopurinol capsule once daily from Day -7 to Day -1. During treatment period, participants in cohort 1 will receive placebo matching allopurinol capsule and placebo matching verinurad capsule once daily from Day 1 to Day 7.
15875849|NCT03836586|Behavioral|Cognitive-Behavioral Intervention|This intervention comprises three components: 1) general education about pain (e.g., pain pathways) and a rationale for the intervention (e.g., gate control theory); 2) impact of positive and negative pain-related thoughts on neural process of pain; and 3) a guided imaginal pain exposure exercise.
15875850|NCT03836586|Behavioral|Pain Education|General information about the neurobiology of pain and knee osteoarthritis will be given to participants assigned to this intervention.
15875851|NCT03836573|Behavioral|Smoking Cessation iPad Decision Aid Tool|Patients will be provided with the iPad-delivered decision aid. The patient will answer a series of questions and based on their responses be shown information based on the group of which they are a member: 1. Uninterested in quitting cigarettes (Harm-reduction Group); 2. Interested in quitting and using e-cigarettes (E-cigarette Cessation Group); 3. Interested in quitting but does not use e-cigarettes (Standard Smoking Cessation Group). Upon visiting the patient, the physician will address smoking cessation with the patient incorporating the provided decision aid results.
15875852|NCT03836560|Drug|Nicotine patch|nicotine patch given for 8 weeks
15875853|NCT03836560|Drug|Nicotine gum|nicotine gum given as requested
15875854|NCT03836547|Behavioral|Coaching and Weight Loss for patients with dyspnea|Patients with lung disease and a BMI of 35 or greater who suffer from shortness of breath will be invited to participate in a study involving a commercial weight loss application with health coaching. The patients will subscribe on their own to the weight loss application. The patients will be provided with a blue tooth scale so that they may weigh themselves weekly. A health coach will call them weekly for 8 weeks.
15875855|NCT03836547|Behavioral|Active Control|Participants will receive usual care for 12 weeks followed by the active intervention.
15875856|NCT03836534|Behavioral|adherence to treatment of patients coming out of emergencies|Phone contact of patients within 48 hours of the consultation
15875857|NCT03836521|Device|Transcatheter aortic valve replacement|
15875858|NCT03836508|Device|Medium cut-off|"All the dialysis sessions in this arm will be performed with the medium cut-off membrane (MCO) manufactured by Baxter International Corp. membrane for three months. This membrane will exclusively be used in hemodialysis. After third month, all patients will be switched to high-flux membrane manufactured by Fresenius.
~Modalities of hemodialysis : Blood flow: 300-400 mL/min; Dialysate flow: 500-800 mL/min"
15875859|NCT03836508|Device|High-Flux|"All the dialysis sessions in this arm will be performed with the high-flux membrane manufactured by Fresenius for three months. This membrane will exclusively be used in hemodialysis. After third month, all patients will be switched to MCO manufactured by Baxter International Corp.
~Modalities of hemodialysis : Blood flow: 300-400 mL/min; Dialysate flow: 500-800 mL/min"
15875860|NCT03836495|Dietary Supplement|lysine and phosphorus|addition of lysine and essential amino acid and/or phosphorus an essential mineral
15875861|NCT03836482|Device|Selective Cytopheretic Device|Treatment will be delivered for 6 hours a day for up to 6 consecutive days.
15875862|NCT03836456|Behavioral|Mindfulness-based Stress Resilience Training|Mindfulness is a form of cognitive training that cultivates self-regulative ability and enhances resilience
15875864|NCT03836443|Other|"western diet meal"|"A western diet meal (high saturated fat, high refined sugar, high fructose) will be administered in each group (800 kcal/meal) after an overnight fast."
15875865|NCT03836430|Behavioral|Newborn Behavioral Observation-Family Wellness (NBO-FW)|The intervention has been described in the arm description.
15875867|NCT03836404|Device|Iliac crest reconstruction surgery|When autologous bone graft is needed for the treatment of non-unions or bone defects, is harvested from the pelvic iliac crest. Harvested tricortical graft blocks are used to facilitate fusion of joints (ie pubis symphysis, sacroiliac joint), to structurally support metaphyseal areas of articular impaction injuries and to fill in metaphyseal bone voids. The GreenBone device, with its inherent physical and biomimic properties, possesses similar structural properties to bone, thus, being the ideal material to be used for the treatment of the bone defect (3- 4cm) induced from the harvested tricortical iliac crest, restoring therefore the pelvic anatomy and minimising the risk of chronic pain, haematoma formation and herniation of the abdominal contents.
15875868|NCT03836391|Behavioral|Nudge|Nudge is a smartphone-app-based micro-randomized trial that tests the effect of 7 intervention message types based on behavior change techniques on daily goal attainment. Participants have three daily goals: weigh daily, red foods goal, and active minutes goal.
15875869|NCT03836378|Procedure|BioXclude™|The addition of BioXclude™ dehydrated human amnion-chorion membrane into deep pockets with scaling and root planing.
15875870|NCT03836365|Other|Preoperative counseling office visit|All patients undergo a preoperative counseling session prior to surgery. Participants in this arm will have an in person preoperative counseling office visit.
15875871|NCT03836365|Other|Preoperative counseling phone call|All patients undergo a preoperative counseling session prior to surgery. Participants in this arm will have a preoperative counseling phone call.
15875872|NCT03836352|Other|DPX-Survivac|SubQ injection (q9w)
15875873|NCT03836352|Drug|Cyclophosphamide|PO (BID)
15875874|NCT03836352|Drug|Pembrolizumab|IV Infusion (q3w)
15875875|NCT03836326|Other|Sensorimotor intervention|Sensorimotor intervention involves, stroking of the whole body including the oral structures, trunk and limbs. This intervention does not involve any drugs or medical procedure.
15875876|NCT03836326|Other|Control|Routine care provided by health professionals in the NICU
15875877|NCT03836313|Device|iovera°|"Cryoneurolysis treatment using the iovera° device targeting the anterior femoral cutaneous nerve (AFCN) and the infrapatellar branch of the saphenous nerve (ISN) will occur approximately 4 weeks before surgery by a trained member of the study staff. Treatment will occur in clinic using suggested anatomical markings to target appropriate the AFCN and infrapatellar branch of the saphenous nerve (ISN) of the operative knee.
~The iovera° device contains three 27- gauge needles, all 6.9mm in length which will indent the subjects' skin and be inserted under the subcutaneous fat about 7 mm. Lidocaine will be used for superficial anesthetic at the treatment site before the needles puncture the patient's skin.There are a total of 9 iovera° cooling cycles. Treatment will be performed unilaterally and will be guided by visualization and palpation of anatomical landmarks."
15875878|NCT03836300|Behavioral|Parent-Infant fragile x Intervention (PIXI)|"Phase 1 will include parent education about early infant development and FXS along with parent-child interaction activities.
~Phase 2 includes direct parent coaching around parent-child interaction based on an empirically based parent-mediated early intervention, Infant Start, and repeated comprehensive assessments of family and child functioning."
15875879|NCT03836287|Drug|Sofpironium Bromide, 15%|Active
15875880|NCT03836287|Drug|Vehicle|Vehicle gel
15875881|NCT03836274|Dietary Supplement|AYMES MONACO|AYMES MONACO is a Food for Special Medical Purposes (FSMP) and must, therefore, be used under medical supervision. It is not designed as a sole source of nutrition.
15875882|NCT03836261|Drug|Acalabrutinib|Acalabrutinib,
15875883|NCT03836261|Drug|Venetoclax|Venetoclax
15875884|NCT03836261|Drug|Chemoimmunotherapy|fludarabine/cyclophosphamide/rituximab (FCR), bendamustine/rituximab (BR)
15875885|NCT03836261|Drug|Obinutuzumab|Obinutuzumab
15875886|NCT03836248|Other|Osteopathic treatment|"5 osteopathic treatment sessions lasting 20 to 40 minutes. Each session include diagnosis according to the specific methodology geometric model of osteopathy and treatment of necessary elements and a control of osteopathic treatment at the end of the session."
15875887|NCT03836248|Other|Sham osteopathic treatment|"5 sham osteopathic treatment sessions lasting 20 to 40 minutes. Each session include diagnosis according to the specific methodology geometric model of osteopathy and only contacts for no intent to treat. At the end of the session a control of the sham osteopathic treatment is performed."
15875888|NCT03836248|Other|Current practice Medication treatment|Analgesic medication of level 1 or a combination of level 1 and 2. Acetaminophen 1 g x 3 / day Ibuprofen 400mg x 3 / day
15875889|NCT03836222|Drug|PCS499|MR tablet
15875890|NCT03836222|Drug|Trental|comparator tablet
15875891|NCT03836209|Drug|Gilteritinib|"Induction: 120 mg orally daily x 14 days starting on day 8
~Consolidation: 120 mg orally daily x 14 days starting on day 8 of each cycle (up to 4 cycles)"
15875892|NCT03836209|Drug|Midostaurin|"Induction: 50 mg orally twice daily x 14 days beginning on day 8
~Consolidation: 50 mg orally twice daily x 14 days beginning on day 8 of each cycle (up to 4 cycles)"
15875893|NCT03836209|Drug|Daunorubicin|"First Induction: Daunorubicin 90 mg/m²/day IV Days 1,2,3
~Second Induction, if needed: Daunorubicin 45 mg/m²/day IV Days 1,2,3"
15875894|NCT03836209|Drug|Cytarabine|"Induction: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1
~Second Induction, if needed: Cytarabine 100 mg/m²/day continuous infusion x 7 days starting Day 1
~Consolidation: Cytarabine 3 g/m² (recommend 1.5 g/m² for age ≥ 55 or patients with decreased creatinine clearance) every 12 hours IV Days 1,3,5 or Days 1-3 for 6 doses for up to 4 cycles"
15875895|NCT03836196|Radiation|LDR Brachytherapy and External Beam Radiation Therapy|Low Dose Rate Brachytherapy (LDR-PB) and External Beam Radiation Therapy (EBRT)
15875896|NCT03836183|Diagnostic Test|Pleuropulmonary ultrasound with clinical examination|Pleuropulmonary ultrasound associate with a clinical examination
15875974|NCT03835533|Drug|Nivolumab (Cohort A, B and C)|Nivolumab will be administered intravenously every 3 weeks for up to 2 years to cohort A, every 4 weeks for up to 2 years for cohort B and C.
15877157|NCT03826550|Other|Placebo|Twice daily for 60 days. Each patient is expected to receive 120 doses
15875897|NCT03836170|Procedure|Laparoscopic cholecystectomy|A special catheter was inserted into the peritoneal cavity, and then about 2-5 liters of carbon dioxide was injected. After reaching a certain pressure, four small holes of 0.5-1.5cm were opened in the abdomen to dissect the structure of the triangle of the gallbladder. The gallbladder duct and gallbladder artery were cut off and closed, and then the entire gallbladder was removed.
15875898|NCT03836157|Drug|Mirvetuximab Soravtansine|The dose will not be recalculated unless the patient has ±10% weight change.
15875899|NCT03836157|Drug|Bevacizumab|Subject will receive IMGN853 first followed by bevacizumab. There is no planned delay between the IMGN853 and bevacizumab administration.
15875900|NCT03836144|Dietary Supplement|Potassium citrate|
15875901|NCT03836118|Procedure|Homologous intrauterine insemination (IUI)|"Patients were treated with HMG/rFSH according to classic protocols of therapy and monitoring. An injection of uHCG 5000 IU/ rHCG 250 mg was given to trigger ovulation. On the day of insemination, the semen sample was obtained through masturbation after a 2-5 day abstinence period and collected in a sterile cup. TMSC was determined by multiplying grade A or grade A + B sperm motility percentages by sperm volume and concentration. To evaluate sperm viability Eosin and Nigrosin (E&N) staining was carried out according to WHO standards. Sperm capacitation was performed using density gradient centrifugation or swim-up procedure in order to remove seminal fluids and enhance sperm quality for IUI.
~IUI was performed a t36 hours post-HCG. A fraction of the washed motile spermatozoa was inserted up to the uterine fundus and expelled into the uterine cavity. Daily treatment with micronized progesterone was prescribed for 14 days after IUI. Serum ß-HCG was determined 14 days after IUI."
15875902|NCT03836105|Drug|cemiplimab|No investigational agents will be provided to enrolled patients by the sponsor as part of this study. Patients will have recently initiated or be planning to initiate treatment with commercially available cemiplimab for advanced CSCC or advanced BCC in a real-world setting according to respective label indications. In addition to cemiplimab, patients may receive other therapies as deemed necessary by their physicians for the treatment of CSCC or BCC or comorbid conditions.
15875903|NCT03836092|Procedure|Radiofrequency ablation|RF applications were delivered with a maximal temperature of 43°C at the catheter tip (SmartTouch Navistar Thermocool catheter) and at the power between 25-50 watts. The primary end points during RF ablation were either complete elimination of areas with CFAE or conversion of AF to normal sinus rhythm (SR). When areas with CFAE were completely eliminated but the atrial arrhythmias persisted (organized atrial flutter or atrial tachycardia), they were subsequently mapped and ablated (occasionally in conjunction with ibutilide, 1 - 2 mgs intravenously over 10 minutes).
15875904|NCT03836079|Device|preCARDIA system|Intermittent occlusion of the SVC
15875905|NCT03836066|Drug|Atezolizumab-Bevacizumab|Atezoluzumab 1200 mg + Bevacizumab 15 mg / kg
15875906|NCT03836053|Drug|AMG 420|28 day continuous Intravenous infusion of either 400 mcg/d or 600 mcg/d followed by 2 treatment free weeks
15875907|NCT03836040|Drug|Erenumab Dose 1|Subjects in the low body-weight group at day 1 and who are randomized to Dose Level 1 will receive this dose.
15875908|NCT03836040|Drug|Erenumab Dose 2|Subjects in the low body-weight group at day 1 who are randomized to Dose Level 2 and subjects in the high body-weight group at day 1 who are randomized to Dose Level 1 will receive this dose.
15875909|NCT03836040|Drug|Erenumab Dose 3|Subjects in the high body-weight group at day 1 who are randomized to Dose Level 2 will receive this dose.
15875910|NCT03836040|Other|Placebo|Placebo matching dose for erenumab dose 1, 2 and 3.
15875911|NCT03836027|Other|No intervention|No intervention
15875912|NCT03836014|Combination Product|Daratumumab/Lenalidomide/Dexamethasone for 24 months|"Conditioning regimen: 16 mg/kg IV :
~Weekly (Cycles 1 and C2)
~Every two weeks (C3 to C6)
~Monthly from C7 up to 24 months in total (Arm 1)
~Infusion reaction prophylaxis :
~Acetaminophen (paracetamol) 650-1000 mg IV or orally (PO) approximately 1 hour or less prior to infusion
~An antihistamine (diphenhydramine 25-50 mg IV or PO, or equivalent but avoid IV use of promethazine) approximately 1hour prior to infusion; after Cycle 6, if a subject has not developed an infusion-related reaction and is intolerant to antihistamines, modifications are acceptable as per investigator discretion
~Dexamethasone 40 mg IV (preferred) or PO, approximately 1 hour or less prior infusion.
~Lenalidomide:
~Conditioning regimen: 25 mg per os. From day 1 to day 21 of each cycle up to 24 months in total (Arm 1)
~Dexamethasone:
~Conditioning regimen: 40 mg at day 1 (preinfusion medication IV preferred), day 8, day 15 and day 22 per os of each cycle up to 24 months in total (Arm 1)"
15875913|NCT03836014|Combination Product|Daratumumab/Lenalidomide/Dexamethasone until progression|"Conditioning regimen: 16 mg/kg IV :
~Weekly (Cycles 1 and C2)
~Every two weeks (C3 to C6)
~Monthly from C7 until disease progression (Arm 2).
~Infusion reaction prophylaxis :
~Acetaminophen (paracetamol) 650-1000 mg IV or orally (PO) approximately 1 hour or less prior to infusion
~An antihistamine (diphenhydramine 25-50 mg IV or PO, or equivalent but avoid IV use of promethazine) approximately 1hour prior to infusion; after Cycle 6, if a subject has not developed an infusion-related reaction and is intolerant to antihistamines, modifications are acceptable as per investigator discretion
~Dexamethasone 40 mg IV (preferred) or PO, approximately 1 hour or less prior infusion.
~Lenalidomide:
~Conditioning regimen: 25 mg per os. From day 1 to day 21 of each cycle until disease progression (Arm 2).
~Dexamethasone:
~Conditioning regimen: 40 mg at day 1 (preinfusion medication IV preferred), day 8, day 15 and day 22 per os of each cycle until disease progression (Arm 2)."
15875914|NCT03836001|Drug|Serlopitant Tablet|Serlopitant is a small molecule, highly selective NK1-R (neurokinin-1 receptor) antagonist. Two critical mediators of the urge to scratch are Substance P, or SP, and its receptor, NK1-R. SP is a naturally occurring peptide in the tachykinin neuropeptide family. Tachykinins have a broad range of functions in the nervous and immune systems. SP binding of NK1-R has been shown to be a key mediator of sensory nerve signaling, including the itch-scratch reflex and the vomiting reflex.
15875915|NCT03836001|Drug|Placebo Oral Tablet|The placebo is a tablet that looks like a drug but has no drug or other active ingredient in it.
15875916|NCT03835988|Device|Geniculate Artery Embolization|Embolization is a procedure completed by an Interventional Radiologist in which abnormal blood vessels are blocked for treatment purposes. In the case of geniculate artery embolization, abnormal blood vessels which supply your knee joint are blocked in an effort to reduce inflammation and subsequently and reduce pain and improve joint function.
15875917|NCT03835975|Biological|13vPnC|Pneumococcal conjugate vaccine
15875918|NCT03835975|Biological|PPSV23|Pneumococcal polysaccharide vaccine
15875919|NCT03835975|Biological|20vPnC|Pneumococcal conjugate vaccine
15875920|NCT03835962|Device|NeuroCatch™ Platform|NeuroCatch Platform™ consists of software and hardware that captures brain health information. The platform intends to provide a quick, portable and easy to use solution for the acquisition, display, analysis, storage, reporting and management of electroencephalograph (EEG) and event-related potential (ERP) information.
15875921|NCT03835949|Drug|TJ004309|Antibody to CD73
15875922|NCT03835949|Drug|Atezolizumab|Humanized monoclonal antibody to PD-L1
15875923|NCT03835936|Other|High frequency compression of the chest wall group|The protocol in the high frequency compression of the chest wall group device consists of the Smart Vest® application, with a fixed frequency of 13 Hz and a time of 15 minutes. The selected mode will be the normal (fixed parameters) and the pressure of 4 units (12 cm H2O). The patient remains seated on his parents, and with a cotton garment between the vest and the skin of the patient to prevent skin lesions.
15875924|NCT03835936|Other|Manual maneuvers physiotherapy group|20 minutes of manual maneuvers physiotherapy based on prolonged slow expiration: passive technique of expiratory help applied to the baby through a slow thoracic-abdominal pressure that begins at the end of spontaneous expiration and continues to the residual volume. The physiotherapist through the cough provoked or stimulation of the trachea gets expectoration of sputum, to be able to assess its weight.
15875925|NCT03835923|Behavioral|lifestyle intervention|"intervention phase 1 (baseline - month 6): Patients receive an individual exercise plan, nutritional recommendations and advices to increase daily activity. The intervention is accompanied by regular oral and written feedback.
~intervention phase 2 (month 6 - month 12): Patients receive an individual exercise plan, nutritional recommendations and advices to increase daily activity without additional oral or written feedback."
15875926|NCT03835923|Behavioral|usual care|Recommendation for lifestyle intervention at baseline and after 6 months (e.g. salt reduction, restricted alcohol consumption and smoking cessation, 10,000 steps/day, 150 minutes/week moderate intensity exercise)
15875927|NCT03835910|Behavioral|Social Incentives and Gamification to Promote Exercise|The intervention will provide social incentives and gamification to promote physical activity.
15875928|NCT03835910|Procedure|Corticosteroid Injection given in A-B order|The study will compare corticosteroid injections with lidocaine to lidocaine only in a crossover design. These participants will receive the medication in A-B order.
15875929|NCT03835910|Behavioral|No Social Incentive applied|No social incentive will be applied
15875930|NCT03835910|Procedure|Corticosteroid Injection given in B-A order|The study will compare corticosteroid injections with lidocaine to lidocaine only in a crossover design. These participants will receive the medication in B-A order.
15875931|NCT03835884|Drug|AR-13503 Implant 10.6 Dose|AR-13503 Implant 10.6 Dose (10.6 µg) administered as an intravitreal implant into a single eye
15875932|NCT03835884|Drug|AR-13503 Implant 21.2 Dose|AR-13503 Implant 21.2 Dose (21.2 µg) administered as intravitreal implants into a single eye
15875933|NCT03835884|Drug|AR-13503 42.4 Dose|AR-13503 Implant 42.4 Dose (42.4 µg) administered as intravitreal implants into a single eye
15875934|NCT03835884|Drug|AR-13503 63.6 Dose|AR-13503 Implant 63.6 Dose (63.6 µg) administered as intravitreal implants into a single eye
15875935|NCT03835871|Drug|Placebo|Intervention: Drug: placebo
15875936|NCT03835871|Drug|400 µg per day Beclomethasone|Intervention: Drug: Beclomethasone 400 µg HFA per day
15875937|NCT03835871|Drug|200 µg per day Beclomethasone|Intervention: Drug: Beclomethasone 200 µg HFA per day
15875938|NCT03835871|Drug|100 µg per day Beclomethasone|Intervention: Drug: Beclomethasone 100 µg HFA per day
15875939|NCT03835858|Other|Respiratory physiotherapy|The protocol consists of 20 minutes of FR based on nasal washes in sitting, prolonged slow expiration: passive technique of expiratory help applied to the baby through a slow thoracic-abdominal pressure that begins at the end of a spontaneous expiration and continuing to the residual volume. The physiotherapist through the the provoked cough or stimulation of the trachea achieves the expectoration of the sputum.
15875940|NCT03835845|Device|PICO7Y|The PICO 7Y pump maintains NPWT at -80 mmHg (nominal) to two wound surfaces simultaneously. Exudate is managed by the dressings through a combination of absorption and evaporation of moisture through the outer film. The PICO 7Y kit is intended to be used for up to 7 days on low exuding wounds. For moderately exuding wounds the system is intended to be used for up to 4 days without a dressing change. For 7 days use on moderately exuding wounds additional dressings will be supplied.
15875941|NCT03835832|Other|The participants do not receive any intervention for this study|The participants do not receive any intervention for this study
15875942|NCT03835819|Drug|Pembrolizumab|Pembrolizumab is an immunotherapy that activates a patient's own immune system to recognize and kill tumor cells
15875943|NCT03835819|Drug|IMGN853|Mirvetuximab soravtansine is an antibody-drug conjugate.
15875944|NCT03835806|Other|Elastikon|This randomized controlled trial will compare the traditional method of treating blisters with a multi-step approach of percutaneous drainage, paper tape, spray adhesive and then Elastikon which is our traditional blister treatment approach.
15875945|NCT03835806|Other|Rocktape|This randomized controlled trial will compare the traditional method of treating blisters with a multi-step approach of percutaneous drainage, paper tape and then Rocktape which is our novel blister treatment approach.
15875946|NCT03835793|Diagnostic Test|CAC-score|Testing for possible unfavourable health effects of early surgical menopause
15875947|NCT03835780|Other|No intervention|A observation of outcomes in usual practice
15875948|NCT03835767|Other|Peanut flour and Oat flour (placebo for peanut flour)|Peanut flour (12% light roast) with 50% protein content is manufactured by Byrd Mill. Oat flour is manufactured by GF Harvest.
15875949|NCT03835767|Other|Dry Milk Powder and Corn Starch (placebo for Milk powder)|Dry milk powder with 36% protein content is manufactured by Giant Food. Corn starch is Argo brand.
15875950|NCT03835767|Other|Baked milk and Rice milk (placebo for Baked milk)|Baked milk will be in the form of a muffin provided by the NIH CC Nutrition Department. Rice milk is manufactured by Rice Dream brand.
15875951|NCT03835754|Device|OCS Heart System|The OCS Heart System preserves the heart in a near-physiological, beating state by perfusing the heart with a warmed, donor-blood based perfusate that is supplemented with nutrients and oxygen in a controlled and protected environment
15875952|NCT03835741|Device|FreeO2|an automated adjustment of oxygen during patient hospitalisation by FreeO2 device
15875953|NCT03835741|Other|manual titration|a manual adjustment of oxygen during patient hospitalisation by hospital staff
15875956|NCT03835715|Drug|Vortioxetine|Flexible doses (10-20 mg) of vortioxetine; 10 mg during the first week which may be increased up to 20 mg week 2-8
15875957|NCT03835702|Other|SAM Clinic Intervention|SAM Clinic is a sleep provider led team comprised of either a sleep clinician or sleep nurse practitioner along with sleep nurses and or durable medical equipment representative. The provider interacts with each patient personally. Various modes of trouble shooting of PAP related issues are tailored to solve PAP adherence issues including mask complaints, nasal issues, pressure intolerance, anxiety, and other related barriers to PAP adherence. When the provider is seeing patients individually other patients have the opportunity to interact and offer informal interpersonal support to other participants in dealing with similar PAP issues. The provider makes an individualized follow-up plan for each patient, which may include another SAM visit or referral back to the non-sleep provider.
15875958|NCT03835689|Behavioral|Strongest Families Intervention (formerly Family Help)|Distance HEALTH education intervention focused on skill learning for parents
15875959|NCT03835676|Drug|Treprostinil|"After inclusion and baseline measurements, patients will receive treprostinil in addition to background therapy for 24 months. Follow-up assessment will include:
~Clinical, echocardiographic, laboratory assessments will be repeated at 1, 3, 6, 12, 18, and 24 month (or when there is clinical indication)
~CMR will be performed at 6 monthly intervals for 2 years.
~Peak power output at 6,12, 18 and 24 month
~Right-side cardiac catheterization will be performed at 6, 12 , 18 and 24 months (or when there is clinical indication)"
15875960|NCT03835663|Diagnostic Test|No intervention but patients are undergoing an upper GI endoscopy and biopsies for clinical purposes|Standard upper GI endoscopy with biopsies
15875961|NCT03835637|Drug|ORIC-101|Capsule or oral suspension
15875962|NCT03835624|Diagnostic Test|interleukin 33|serum and synovial fluid samples will be obtained from patients and serum samples from controls to measure interleukin 33 and its relative mRNA expression in peripheral blood mononuclear cells by PCR
15875963|NCT03835611|Other|Game based treadmill Platform|"The protocol for the intervention group will be:
~Warm up exercised consisting of rhythmical large movements (10minutes)
~Dynamic standing balance training by playing commercial games with head rotations while standing on a compliant surface to increase balance demands. (10 Minutes)
~DT treadmill training, consisting of playing commercial computer games while walking on the treadmill at a self-selected comfortable speed. Participants will be allowed to take rest when required and total effective DT treadmill walking will be for 30minutes. Treadmill speed will be aimed to progress depending on participant performance and documented. An overhead safety harness will always be provided to participants while walking on the treadmill. (25minutes)"
15875964|NCT03835611|Other|Control Group|"Warm-up exercise consisting of rhythmical large movements (10 minutes).
~Core standing balance exercises on a sponge surface (10 minutes).
~Treadmill walking for 20 minutes, which includes rests periods... An overhead safety harness will be provided to participants while walking on the treadmill
~Overground walking in an obstacle course. Participants will be instructed to walk along a curved path (marked by tape) and avoid obstacles placed randomly. The obstacle will be thin sponge pads with 10-12 inches in diameter (15minutes)."
15875965|NCT03835585|Device|Gun lock|A cable-style gun lock that can be applied to a wide variety of guns for safe storage. The application of this device to most firearms renders them impossible to use properly while the device is in place and locked.
15875966|NCT03835585|Other|Suicide Risk Assessment|Thorough suicide risk assessment according to guidelines established by research (Joiner et al., 1999; Chu et al., 2015). This is used to determine the severity of suicide risk and appropriate actions to be taken.
15875967|NCT03835585|Behavioral|Safety Planning|A psychological intervention for suicide risk that is based on research (Chu et al., 2015; Stanley & Brown, 2012). This involves listing the following on an index card: activities individuals can use to feel better during a crisis, contact numbers that are important to the individuals, emergency options that are always accessible, and reasons for living. Although the individualized nature of safety plans does not allow for a scripted/uniform approach, for this study they will all include 8 steps and steps 5-8 (emergency options) will be the same for each individual.
15875968|NCT03835585|Behavioral|Lethal Means Counseling|A psychological intervention for suicide risk that is based on research (Bryan et al., 2011; Chu et al., 2015; Rudd, 2006; Stanley, 2018). This involves a psychological clinician discussing, with an at-risk individual, the importance for increasing the distance/obstacles between the individual at risk for suicide and specific types of lethal means. In the present study, the lethal means targeted was firearms and the lethal means counseling approach was able to be standardized/scripted as has been done in previous research (see Stanley, 2018).
15875969|NCT03835572|Other|CircaHealth: a course on circadian rhythms and health|Participants will receive videos, behavioral modification checklists, and quizzes every week for six weeks.
15875970|NCT03835572|Other|Sleep hygiene materials|Participants in the control group will receive weekly materials from the National Sleep Foundation and American Academy of Sleep Medicine on sleep hygiene
15875971|NCT03835559|Procedure|Cyanoacrylate closure|After successful access of target vein and insertion of guidewire under any type of anesthesia, the procedure of cyanoacrylate closure is performed. A 5 French introducer and catheter is advanced and positioned 5.0 cm caudal to the junction with proximal saphenous vein compression by the ultrasound probe, two injections of approximately 0.10 mL glue are given 1 cm apart, followed by a 3min period of compression, and then repeat injections and 30sec ultrasound probe and hand compression sequences until the entire length of the target vein is treated. The catheter is removed.
15875972|NCT03835559|Procedure|Surgical stripping|All types of anesthesia (general, spinal, regional block, or local anesthesia) can be used. The surgical stripping is performed with a proper incision in the groin, with division and ligation of the saphenous vein and division of all tributaries. The saphenous vein is then removed using a stripper.
15875973|NCT03835533|Drug|NKTR-214 (Cohort A)|NKTR-214 will be administered intravenously every 3 weeks for up to 2 years
15876047|NCT03834909|Drug|Pregnancy-adjusted dose Truvada®|TDF/FTC fixed dose combination, 300 mg TDF/200 mg FTC, two tablets each day
15875975|NCT03835533|Radiation|Stereotactic body radiation therapy (SBRT) (Cohort B)|Radiation therapy will be administered at 30 - 50 Gy in 1 - 5 doses, starting on Day 1 or 2 of Cycle 1
15875976|NCT03835533|Drug|CDX-301 (Cohort B and C)|CDX-301 will be subcutaneously once a day for 5 days for cohort B. CDX-301 will be subcutaneously once a day for 10 days of immune-priming lead-in for cohort C.
15875977|NCT03835533|Drug|Poly-ICLC (Cohort B)|Poly-ICLC will be administered intramuscularly twice weekly for 3 weeks starting on Day 1 of Cycle 1
15875978|NCT03835533|Drug|INO-5151 (Cohort C)|INO-5151 will be administered intramuscularly on Day 8 of the Immune-priming Lead-in, and on day 1 of Cycle 1, 2 and 3, then every 12 weeks thereafter
15875979|NCT03835533|Device|Cellectra 2000|Electroporation device
15875980|NCT03835520|Drug|Immunotherapeutic Agent|Immunotherapy will be administered according to standard of care and reimbursement modalities in Belgium.
15875981|NCT03835520|Drug|Molecular Target|Targeted agents will be administered according to standard of care and reimbursement modalities in Belgium. Targeted agents will be administered according to manufacturer's instructions.
15875982|NCT03835507|Drug|recombinant human erythropoietin(rhEPO)|Injection of erythropoietin every months (total 12 months)
15875983|NCT03835494|Other|Transthoracic echocardiography at rest, during PLR, HG and CPX (including blood gas analysis in both groups). Additionally Fallot patients will undergo routine blood testings.|Transthoracic echocardiography at rest, during PLR, HG and CPX (including blood gas analysis in both groups). Additionally Fallot patients will undergo routine blood testings.
15875984|NCT03835481|Drug|BI 730357|Film-coated tablet
15875985|NCT03835481|Drug|Placebo to match BI 730357|Film-coated tablet
15875986|NCT03835468|Dietary Supplement|Galacto-oligosaccharides|GOS is a form of prebiotic, which enhance the growth of beneficial gut bacteria
15875987|NCT03835468|Dietary Supplement|Maltodextrin|sugar based placebo
15875988|NCT03835442|Drug|Baclofen|baclofen 10mg tid for 4 weeks
15875989|NCT03835442|Other|Placebos|placebo tid for 4 weeks
15875990|NCT03835429|Device|MyTAP oral appliance plus mouth shield|The midline traction oral appliance (MyTAP, Airway Management Inc.(AMI), Dallas Texas) is currently marketed as a medical device to treat snoring and obstructive sleep apnea and is FDA cleared.
15875991|NCT03835416|Dietary Supplement|Foods rich in high quality protein|Along with a weight reduction diet (by instruction), participants will receive high quality protein foods provided to them to include in their daily diet (see study arm description).
15875992|NCT03835403|Other|Activation of HeartRunners|Activation of volunteer citizen first-responders to respond to nearby cardiac arrests
15875993|NCT03835390|Behavioral|SIMDiscovery|The SIMDiscovery program consists of nine stations that were designed to mirror the different stages of the perioperative process. The stations mirror the different stages of the surgical process and provide patients and their families with education regarding what they can anticipate during each aspect of the intervention.
15875994|NCT03835377|Other|Iron-biofortified beans|Iron-biofortified beans (Phaseolus vulgaris L MIB465)
15875995|NCT03835377|Other|Control beans|Control beans (Phaseolus vulgaris L Jamapa variety), identical in color and size
15875996|NCT03835364|Device|Blood measurement|Single fingerprick to measure haemoglobin and haematocrit measurements using the Aptus Home, anaemia home monitoring system.
15875997|NCT03835351|Device|Urinary Catheter|An intraoperative urinary catheter will be inserted which will be taken out at the end of the case
15875998|NCT03835338|Device|Pulmonary Vein Isolation|Pulmonary Vein Isolation by RF Ablation
15875999|NCT03835338|Device|LAA Isolation|LAA Isolation by RF Ablation
15876000|NCT03835338|Device|LAA Occlusion|LAA Occlusion by implantation of the WATCHMAN LAAC Device
15876001|NCT03835325|Dietary Supplement|Cogmax®|Research participants will receive 2 capsules of Cogmax® per day (after lunch) for 12 weeks.
15876002|NCT03835312|Procedure|Sequential transplantation|After successful matching of umbilical cord blood stem cells, patients will receive pretreatment and chemotherapy under protective isolation, followed by thawing and reinfusion of umbilical cord blood stem cells. Immunosuppressive agents will be used for GVHD prevention and anti-infection support will be provided after reinfusion. The status of umbilical cord blood stem cell implantation, immune reconstruction and therapeutic effect will be evaluated. Islet transplantation will be performed in those who meet the conditions. The long-term prognosis will be observed by long-term follow-up.
15876003|NCT03835299|Behavioral|Fear Intervention|Coping information related to the fear that was identified by the participant will be presented via a computer tablet.
15876004|NCT03835286|Drug|Vitamin C|6 grams of Vitamin C in 250 ml of 0.9% saline in continuous infusion for 24 hours, 3 doses.
15876005|NCT03835286|Drug|Placebos|Placebos: 250 ml of 0.9% saline in continuous infusion for 24 hours, 3 doses.
15876006|NCT03835273|Other|3D motion capture system|Small reflective markers and inertia measurement units will be placed on the chest of the patients using hypoallergenic adhesive and a motion capture system will pick up a 3D image via these markers non-invasively.
15876007|NCT03835273|Other|Incentive spirometry|Incentive spirometry is a non-invasive device for assessment of pulmonary function.
15876008|NCT03835273|Other|Questionnaires|Two validated, European Organisation for Research and Treatment of Cancer Quality-of-life Questionnaire Core 30 (EORTC QLQ-C30) and Oesophago-Gastric Module 25 (EORTC QLQ-OG25) and one non-validated satisfaction questionnaire regarding the usability and acceptability of the 3D motion capture system [7,8]
15876009|NCT03835260|Device|Pivot Breath Sensor|The Pivot Breath Sensor measures the level of carbon monoxide in exhaled breath and displays the carbon monoxide value to the user.
15876010|NCT03835221|Device|methafilcon A toric contact lenses|Bilateral daily wear of methafilcon A toric contact lenses
15876011|NCT03835221|Device|fanfilcon A toric contact lenses|Bilateral daily wear of fanfilcon A toric contact lenses
15876012|NCT03835208|Behavioral|High/low carbohydrate distribution|A total of 2x3 days, were the patient follow a detailed diet plan. For 3 days they follow a diet plan where the majority of the carbohydrates are located on either the first part of the day(HMK) or the last part of the day(LMK). 4 days of washout are placed between the two interventions. They will not receive food but will be guided by a trained dietitian and the use of a meal plan.
15876044|NCT03834935|Drug|Cold Cream|Topical application on all lesions, twice daily. Sunscreen will not be indicated, and hygienic habits will not be changed
15876013|NCT03835195|Other|Diabetes Disease Management Program|The attention is carried out in a single physical place, in the city of Medellin. The scheme of intervention in the comprehensive Diabetes Clinic is based on the concept of disease management. The intervention is composed of 5 phases, which apply to all the patients cared for in the institution (access, reception, entry, clinical consultation, management plan, education, pharmaceutical care). The healthcare team consists of 5 endocrinologists, an endocrinologist pediatrician, 7 general practitioners trained in diabetes, 5 pharmacists trained in diabetes and certified in education for patients with diabetes and 3 nutritionists.
15876014|NCT03835195|Other|Usual Care Process|The patients are treated in the cardiovascular risk clinic (general practitioners) of their Primary Healthcare Provider Institution or by specialists in internal medicine, pediatrics or endocrinology in the different Provider Institutions of Health Services of the insurance service network of health or in private doctors' offices assigned to the insurer. In some cases there is assisted consultation (general practitioner - specialist). There is no defined periodicity for follow-up; Appointments are assigned to need, according to the criteria of the treating physicians. In some cases there is remission to educational activities, not necessarily focused on type 1 diabetes.
15876015|NCT03835182|Device|Ultrasound group|Ultrasound 1 MHz, 1.5 W/cm2 for a total of 10 min applied to the lower back
15876016|NCT03835182|Device|Short wave diathermy group|SWD frequency of 27.12MHz applied in continuous mode (thermic) applied to the lower back for twenty minutes
15876017|NCT03835182|Other|Control group|superficial heat, analgesic physical modality and exercise only
15876018|NCT03835143|Procedure|subinguinal varicocelectomy|varicocele ligation done at the level of subinguinal region
15876019|NCT03835117|Drug|Wide-spectrum nutritional supplement|Comprehensive powder with 33 dietary supplements and 1 dietary supplement via gel capsule.
15876020|NCT03835117|Other|Placebo|Inactive placebo comparator
15876021|NCT03835104|Device|CRP point-of-care testing|CRP point-of-care test using a fingerprick of blood and producing a result within 4 minutes, using the Afinion 2 (Abbott)
15876022|NCT03835091|Other|BRASS score|Brainstem response on neurologic examination
15876023|NCT03835078|Device|methafilcon A contact lenses|Bilateral daily wear of methafilcon A contact lenses
15876024|NCT03835078|Device|fanfilcon A contact lenses|Bilateral daily wear of fanfilcon A contact lenses
15876025|NCT03835065|Procedure|Closed Reduction|The primary goal of closed reduction is to maintain appropriate bony alignment and angulation to allow for appropriate healing.
15876026|NCT03835065|Other|Long Arm Fiberglass Cast|A stockingette and webril will first be applied, after which the short arm fiberglass portion of the cast will be applied. After short arm casting has been appropriately placed, randomization group will be revealed. Casting will be extended to the shoulder joint if the patient is assigned to the long arm cast group. The mold will then be applied and cast construct will be bivalved and taped.
15876027|NCT03835065|Other|Short Arm Fiberglass Cast|A stockingette and webril will first be applied, after which the short arm fiberglass portion of the cast will be applied. After short arm casting has been appropriately placed, randomization group will be revealed. Casting will be complete at this point if the patient is assigned to the short arm cast group. The mold will then be applied and cast construct will be bivalved and taped.
15876028|NCT03835039|Device|NIRS|Monitoring cerebral and perirenal perfusion using NIRS
15876029|NCT03835013|Drug|Saline 0.9%|Intravenous infusion of 0.9% saline
15876030|NCT03835013|Drug|GLP-1 7-36 amide (0.6pmol/kg/min)|Intravenous infusion of GLP-1 7-36 amide 0.6pmol/kg/min
15876031|NCT03835013|Drug|GLP-1 7-36 amide (1.2pmol/kg/min)|Intravenous infusion of GLP-1 7-36 amide 1.2pmol/kg/min
15876032|NCT03835013|Drug|Glucagon (25ng/kg/min)|Intravenous infusion of glucagon 25ng/kg/min
15876033|NCT03835013|Drug|Glucagon (50ng/kg/min)|Intravenous infusion of glucagon 50ng/kg/min
15876034|NCT03835013|Drug|Exenatide|Intravenous infusion of Exenatide (loading 50ng/min for 30 minutes followed by 25ng/min for 30 minutes
15876035|NCT03835000|Procedure|Orthopedic surgery|before and after surgery, patient will need medical imaging to asses their conditions
15876036|NCT03834987|Other|Neurodevelopmental Assessment|Developmental assessment at baseline and longitudinally as measured by age and ability-appropriate scales, including: the Mullen Scales of Early Learning, the Peabody Scales of Motor Development, the Vineland 3, and Beery Visual Motor Integration
15876037|NCT03834974|Behavioral|Sun Safety Social Media Challenge|Participants will attend a webinar to learn how to create effective social media posts about sun safety and be oriented to the social media accounts on which the messages will be posted. They will be informed that posts should include a sun safety message (e.g., promoting sunscreen use and protective clothing/hats or discouraging risk behaviors like tanning and burning). They will be encouraged to be creative so that the message gets likes and shares. Participants will be encouraged to follow the feeds to see the engagement on their posts, to share the posts in their feed, and to see other participants' posts. Participants will receive a $10 Amazon gift card per post for a maximum of 6 posts ($60). The participant who created the post that receives the most likes, comments, and shares each week will win a $50 Amazon gift card.
15876038|NCT03834974|Behavioral|Digital Health Social Media Challenge|Participants will attend a webinar to learn how to create effective social media posts about using technology to get healthy and be oriented to the social media accounts on which the messages will be posted. They will be informed that posts should mention some way that technology (e.g., mobile apps, wearables) can be used to promote a healthy habit (e.g., diet, exercise). They will be encouraged to be creative so that the message gets likes and shares. Participants will be encouraged to follow the feeds to see the engagement on their posts, to share the posts in their feed, and to see other participants' posts. Participants will receive a $10 Amazon gift card per post for a maximum of 6 posts ($60). The participant who created the post that receives the most likes, comments, and shares each week will win a $50 Amazon gift card.
15876040|NCT03834948|Drug|AO-176|Humanized monoclonal antibody (mAb) targeting CD47
15876041|NCT03834948|Drug|AO-176 + Paclitaxel|Humanized monoclonal antibody (mAb) targeting CD47 and paclitaxel
15876042|NCT03834948|Drug|AO-176 + Pembrolizumab|Humanized monoclonal antibody (mAb) targeting CD47 and pembrolizumab
15876043|NCT03834935|Drug|Elidel (pimecrolimus 1%)|topical application of product on all lesions, twice daily. Sunscreen will not be indicated, and hygienic habits will not be changed
15876048|NCT03834896|Other|AYMES MADRID|AYMES MADRID is a gum-based commercial thickener, that can be utilised to modify fluid consistencies to Stage 1, 2 or 3 (as per the National Descriptors for Texture Modification) to enhance the safety of fluids in those with dysphagia.
15876049|NCT03834883|Drug|Progesterone|Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days
15876050|NCT03834883|Drug|Ibutilide|Ibutilide 0.003 mg/kg administered to all subjects to moderately lengthen the QT interval
15876051|NCT03834870|Behavioral|Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES)|Virtual cOaching in making Informed Choices on Elder Mistreatment Self-Disclosure (VOICES) screening tool.
15876052|NCT03834857|Device|StentrodeTM|Implantation of Stentrode TM device
15876053|NCT03834844|Behavioral|Meditation|Guided Meditation for 10-15 minutes daily for 6 days/week for 6 weeks
15876054|NCT03834844|Other|AF Education|6 weekly education modules on topics related to AF
15876055|NCT03834844|Other|Phone Calls|Weekly phone call to discuss patient concerns or questions
15876056|NCT03834831|Dietary Supplement|Coenzyme Q10|Coenzyme Q10
15876057|NCT03834831|Dietary Supplement|Selenium|Selenium
15876058|NCT03834818|Behavioral|COMPAS Participants|"The schedule of events for this study are as follows:
~Day 1 Pre-Surgery:
~Download the Medable App
~Register to the study
~Validated Questionnaires
~Active Task
~Every Day
~9:00 a.m. Daily Questions
~9:00 p.m. Daily Questions
~Outcome Surveys and Active Task:
~Day 1 Pre-Surgery
~1-Week Post Operation
~2-Weeks Post Operation
~1-Month Post Operation
~3-Months Post Operation
~6-Months Post Operation"
15876059|NCT03834805|Other|lung and liver elastography measurement of fetus|Other: lung and liver elastography measurement of fetus
15876060|NCT03834792|Other|No intervention but exposure|Different sleep disorders will be considered as an exposure. The data elements included in the database: demographics, date of the sleep study, study type, all available polysomnography indices, symptoms, sleep schedule, comorbidities, medications, social history, electrocardiography, positive airway pressure treatment related variables.
15876061|NCT03834779|Behavioral|DOORS-CHW Intervention|"The behavioral intervention has been developed for a collaborative CHW and re-entry program intervention that targets HIV outcomes, substance use and recidivism in HIV+ jail releasees.
~Participants will be randomized to the DOORS+CHW intervention versus TAU and all participants will undergo study follow-up visits at 3, 6 and 12 months. In other words, participants randomized to the intervention arm will meet with the CHW and a staff member from DOORS. One of the primary study aims is a randomized controlled trial of an intervention which has a reasonable probability of improving the health and well-being of the subject by improving linkage to social services and the HIV clinic. The control arm will receive standard of care (referrals to case management)."
15876062|NCT03834766|Drug|AMPH ER Tab 5, 10, 15 and 20 mg|Amphetamine
15876063|NCT03834766|Drug|AMPH ER Tab Matching Placebo 5, 10, 15 and 20 mg|Placebo
15876064|NCT03834753|Biological|bevacizumab|1.25 mg, intravitreal injection
15876065|NCT03834753|Biological|ranibizumab|0.5mg, intravitreal injection
15876066|NCT03834740|Drug|Ribociclib|Ribociclib administered orally in 5 daily doses prior to resection
15876067|NCT03834740|Drug|Everolimus|Everolimus administered orally in 5 daily doses prior to resection
15876068|NCT03834714|Device|Near Infrared Light|NIR Light Therapy will be administered with the Earlight Generation 1.4 device during 2 out of the 4 sessions. It will be administered to each ear individually for 30 minutes per ear.
15876069|NCT03834714|Other|Noise Stimulus|Noise stimulus will be administered, open ear, to continuous broadband noise up to 25% of the allowable daily dose of noise per the AFI 48-127 Occupational Noise and Hearing Conservation Program.
15876070|NCT03834714|Device|Sham Near Infrared Light|Sham NIR Light Therapy will be administered with the Earlight Generation 1.4 device during 2 out of the 4 sessions. It will be administered to each ear individually for 30 minutes per ear.
15876071|NCT03834701|Device|EUS guided radiofrequency ablation|The EUS-RFA system (Taewoong, Seoul, Korea) utilized for EUS-RFA consists of an 19-gauge needle electrode (140-cm long), a radiofrequency generator, and an inner cooling system that circulates chilled saline solution during the RFA procedure. The inner metal part is insulated over its entire length, with the exception of the terminal 5 to 20mm for energy delivery. The needle electrode is attached to a radio frequency current generator (VIVA RF generator; Taewoong) and to a cooling pump. The generator, in addition to providing radio frequency current, allows the control of physical power and impedance parameters.
15876072|NCT03834688|Drug|Venetoclax|"Cycle 1: Venetoclax by mouth daily. The dose will gradually increase during Cycle 1. (Day 1-7: 20 mg; Day 8-14: 50 mg; Day 15-21: 100 mg; Day 22-28: 200 mg.)
~Cycles 2-6: Venetoclax 400 mg by mouth daily on Days 1-10 (1 cycle = 28 days)."
15876073|NCT03834688|Drug|Bendamustine|Cycle 1-6: Bendamustine 90 mg/m² intravenous (IV) on Days 1 and 2 of each cycle. Bendamustine may be started at 70 mg/m² in patients over the age of 75 years with comorbid conditions or patients over the age of 80 years without comorbid conditions.
15876074|NCT03834688|Drug|Rituximab|Cycle 1-6: Rituximab 375 mg/m² IV on Day 1 of each cycle. After 2 consecutive cycles of Rituximab IV are well tolerated, Rituximab may be given subcutaneously.
15876075|NCT03834675|Diagnostic Test|transpulmonary thermodilution|Thermodilution was attempted via PICC and via CICC
15876076|NCT03834662|Drug|AVID200|A TGFβ receptor ectodomain-IgG Fc fusion protein inhibitor of TGFβ
15876077|NCT03834649|Procedure|partially de-epithelized connective tissue graft|graft procedures to obtain simultaneous tissue augmentation in the horizontal and vertical dimensions. The donor site was prepared with a full-thickness coronal dissection and a partial-thickness apical dissection.The objectives were to use a single procedure to achieve simultaneously apico-coronal and buccolingual augmentation,to have a smaller open wound in the donor site and less patient discomfort, and to guarantee better revascularization of the onlay section aided by the submerged connective tissue section of the graft.
15876078|NCT03834649|Procedure|Mucograft|"For preprosthetic defects, a standard mucosal augmentation procedure, which is well reported in the literature, was performed. The surgical site produced by the surgery leaves a denuded area supraperiosteally that is addressed by grafting with a xenogeneic collagen membrane (Mucograft).
~purpose of the surgery is to improve the quantity of attached mucosa to facilitate the final dental reconstruction"
15876222|NCT03833635|Other|osteopathic manipulative treatment|OMT will be used to treat premature infants after having performed a manual osteopathic assessment. Techniques used are indirect
15876079|NCT03834636|Procedure|Restorations with nanoparticulated composites and self etch adhesives|The restorations will be placed according to the protocol developed for the care, following the guidelines of the manufacturers, with a self-etching dental adhesive (SingleBond Universal, 3M ESPE), selective enamel etching, and use of a nanoparticulated composite (Z350, 3M ESPE)
15876080|NCT03834636|Procedure|Restorations with nanoparticulated composites and total-etch adhesives|The restorations will be placed according to the protocol developed for the care, following the guidelines of the manufacturers, with a total-etching dental adhesive (SingleBond 2, 3M ESPE), and use of a nanoparticulated composite (Z350, 3M ESPE)
15876081|NCT03834636|Procedure|Restorations with nanohybrid composites and self etch adhesives|The restorations will be placed according to the protocol developed for the care, following the guidelines of the manufacturers, with a self-etching dental adhesive (SingleBond Universal, 3M ESPE), selective enamel etching, and use of a nanohybrid composite (IPS Empress Direct, Ivoclar Vivadent).
15876082|NCT03834636|Procedure|Restorations with nanohybrid composites and total-etch adhesives|The restorations will be placed according to the protocol developed for the care, following the guidelines of the manufacturers, with a total-etching dental adhesive (SingleBond 2, 3M ESPE), and use of a nanohybrid composite (IPS Empress Direct, Ivoclar Vivadent).
15876083|NCT03834623|Drug|CC-122|Oral CC-122 at 2 mg daily, 5 days out of 7
15876084|NCT03834623|Drug|Nivolumab|240 mg Nivolumab intravenously days 1 and 15 in each 28 day cycle
15876085|NCT03834610|Drug|L-arginine 5 gm oral caps|oral L-arginine 5 gm daily for 8 weeks
15876086|NCT03834610|Drug|Tadalafil 10 MG|oral daily tadalafil 10mg for 8 weeks
15876087|NCT03834610|Diagnostic Test|serum testosterone level|measurement of serum testosterone level
15876088|NCT03834610|Diagnostic Test|HbA1C|measurement of HbA1C levels
15876089|NCT03834610|Device|penile doppler|penile doppler to measure the degree of erection and penile vasculature
15876090|NCT03834597|Device|conventional Macintosh laryngoscope|After closure of surgical, anesthesiologist will perform the conventional Macintosh laryngoscope to assess post-thyroidectomy vocal cord mobility.
15876091|NCT03834597|Device|GlideScope®|Patient will be left for a while until hemodynamic stabilization then examination with GlideScope® will be commenced to assess postthyroidectomy vocal cord mobility by another experienced anesthesiologist
15876092|NCT03834584|Drug|AG-636|AG-636 will be administered orally intermittently in 28-day cycles.
15876093|NCT03834571|Drug|Carboplatin|Given IV
15876094|NCT03834571|Drug|Cisplatin|Given IV
15876095|NCT03834571|Drug|Paclitaxel|Given IV
15876096|NCT03834571|Procedure|Patient Monitoring|Undergo active monitoring
15876097|NCT03834571|Radiation|Radiation Therapy|Undergo radiation
15876098|NCT03834558|Other|Mixed exercise program|"A progressive program of high intensity strength and myofascial conditioning will be carried out in 2 non-consecutive weekly sessions (24 weeks). Each session will include:
~A) Warm up on a cycle ergometer
~B) Strength circuit: 6 exercises will be included to strengthen different muscle groups (2 in the upper extremities, 2 in the trunk and 2 in the lower extremities). 3 sets of 10-15 repetitions until the failure. The load will be set to 70% of 1 maximal resistance.
~C) Self-myofascial conditioning: 10 repetitions, in the direction of the fibres of each muscle group, with different materials. 7 muscle groups will be worked (quadriceps, hamstrings, abductors, gluteus, pectoralis, full back and trapezius).
~D) At the end, static stretches will be performed"
15876099|NCT03834532|Other|Breast reconstruction decision aid|The breast reconstruction decision aid is a web-based, interactive tool that participants will use after the first breast surgery visit and before a plastic surgery visit or surgery. The decision aid provides information about post-mastectomy breast reconstruction and helps the participant clarify their preferences related to the procedure.
15876100|NCT03834532|Other|Educational website|The educational website contains information on healthy living with breast cancer including, physical activity and nutrition.
15876101|NCT03834519|Biological|Pembrolizumab|IV infusion
15876102|NCT03834519|Drug|Olaparib|Oral tablets
15876103|NCT03834519|Drug|Abiraterone acetate|Oral tablets
15876104|NCT03834519|Drug|Prednisone|Oral tablets
15876105|NCT03834519|Drug|Enzalutamide|Oral tablets or oral capsules
15876106|NCT03834506|Biological|Pembrolizumab|IV infusion
15876107|NCT03834506|Drug|Docetaxel|IV infusion
15876108|NCT03834506|Drug|Prednisone|Oral tablets
15876109|NCT03834506|Drug|Placebo|IV infusion
15876110|NCT03834506|Drug|Dexamethasone|Oral tablets
15876111|NCT03834493|Biological|Pembrolizumab|IV infusion
15876112|NCT03834493|Drug|Enzalutamide|Capsules/Tablets
15876113|NCT03834493|Drug|Placebo|IV infusion
15876114|NCT03834480|Other|Ultrasound guided Sacroiliac intra-articular injection|At the level of the sacral hiatus, the sacral cornuae were identified. posterior aspect of the sacroiliac joint, at 4.5 cm depth the SIJ was found. localal anesthetic was injected at the medial edge of the transducer, the spinal needle was advanced in a medial to lateral direction, under direct vision, until the needle was positioned in the SIJ. Local steroid solution or PRP 4ml volume was injected according to the study group and patient enrollment. If the injection is extra-articular, injectate (hyperechoic solution as it contains particulate steroid) can be seen spreading medially over the sacrum. The visual analog score, Oswestry Disability Index (ODI) score and the overall success rate basal, after one week,after one month,after three and six month's follow-up period after the initial block.
15876115|NCT03834467|Other|Arm 1 - Elevation Stimulus Video|Subjects will watch a video that has been shown in previous studies to elicit an elevation response. This video shows a news story about a man saving the life of another man who falls onto the subway tracks.
15876116|NCT03834467|Other|Arm 2 - Control Stimulus Video|Subjects will watch a nature video.
15876117|NCT03834454|Drug|Bupivacaine|5 mg hyperbaric bupivacaine 0.5% and 25 mcg fentanyl for spinal anesthesia
15876118|NCT03834454|Drug|Bupivacaine|7.5 mg hyperbaric bupivacaine 0.5% and 25 mcg fentanyl for spinal anesthesia
15876119|NCT03834441|Other|Oral HRSN screening|Verbal screening delivered by an RA
15876120|NCT03834441|Other|Written HRSN screening|Patient completes written screen on iPad.
15876121|NCT03834428|Behavioral|Text Message Intervention|A text message will be sent once daily (between noon and 3p) to remind participants to ambulate at least 3 times each day while hospitalized.
15876122|NCT03834428|Behavioral|ICOUGH protocol|Education will be provided about the ICOUGH protocol which includes: Incentive spirometry (a breathing device that expands the lungs), Coughing and deep breathing, Oral hygiene (for example using a toothbrush), Understanding (patient and family education), Getting out of bed at least three times daily, and Head-of-bed elevation to prevent choking.
15876123|NCT03834415|Dietary Supplement|Lactobacillus reuteri DSM17038|Oil drops of L. reuteri containing 1x10>8 CFU
15876124|NCT03834415|Other|Placebo for Probiotics|Oil drops mimicking in consistency and flavor to experimental product
15876125|NCT03834389|Behavioral|Case- based Learning|critical thinking, self efficacy, focus group interview
15876126|NCT03834376|Drug|Pimodivir|Pimodivir will be administered as tablets taken orally, twice daily (2 tablets of 300 milligram [mg]) over a time period of 5 days.
15876127|NCT03834363|Drug|Fentanyl|Fentanylpatch 12 mcg/hr, change patch every three days.
15876128|NCT03834363|Drug|Morphine Retard|Morphine retard capsules 10 mg bid.
15876129|NCT03834363|Drug|Placebo patch|Placebo patch, change patch every three days.
15876130|NCT03834363|Drug|Placebo oral capsule|Placebo oral capsule bid
15876132|NCT03834324|Device|FES|Functional Electrical Stimulation during cycling with Virtual Reality Feedback
15876133|NCT03834311|Device|isokinetic strengthening|isokinetic upper extremity (forearm) strengthening for 4 weeks 3d/w
15876134|NCT03834311|Other|exercise band strengthening|upper extremity (forearm) strengthening with exercise band 4 weeks 3d/w
15876135|NCT03834298|Other|Four Food Elimination Diet|Food allergens are thought to initiate eosinophilic inflammation and dietary elimination of trigger allergens is an effective treatment for EoE. Previous work demonstrates that in both children and adult EoE patients, the food antigens including cow's milk, wheat, egg, soy, peanut/tree nut and fish/shell fish, are the most common food triggers causing esophageal inflammation. Participants will be assigned to single arm treatment / intervention with a diet restricted of the four most common food allergens, milk, soy, wheat and egg, or a four food elimination diet (FFED). With the goal to optimize diet treatment, in Aim 2, eligible participants will undergo sequential food reintroductions based on protocol.
15876136|NCT03834272|Combination Product|LUM Imaging System|Patients will be injected with one of 2 study doses of LUM015 and tissue will be imaged in vivo and ex vivo with the LUM imaging device.
15876137|NCT03834259|Procedure|sitting position|keeping the patient in a sitting position after spinal anaesthesia
15876138|NCT03834259|Procedure|supine position|keeping the patient in supine position after spinal anaesthesia
15876139|NCT03834233|Drug|Nivolumab|Nivolumab 3mg/kg IV every 14 days until disease progression, unacceptable toxicity or up to 12 months.
15876141|NCT03834207|Device|Use of the C3-Cloud IT system|Patients who are recruited to the intervention arm will use the C3-Cloud system during the pilot study.
15876142|NCT03834194|Behavioral|Lottery + Monthly Weight|"Lottery for daily self-weighing.
~Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis."
15876143|NCT03834194|Behavioral|Lottery + Overall Weight + Exercise|"Lottery for daily self-weighing.
~Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.
~Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists."
15876144|NCT03834194|Behavioral|Lottery + Overall Weight|"Lottery for daily self-weighing.
~Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study."
15876145|NCT03834194|Behavioral|Loss + Overall Weight|"Certain loss for not engaging in daily self-weighing.
~Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study."
15876146|NCT03834194|Behavioral|Loss + Overall Weight + Exercise|"Certain loss for not engaging in daily self-weighing.
~Incentives for gaining weight within a recommended (by Institute of Medicine) by the end of the study.
~Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists."
15876147|NCT03834194|Behavioral|Lottery + Monthly Weight + Exercise|"Lottery for daily self-weighing.
~Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.
~Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists."
15876148|NCT03834194|Behavioral|Loss + Monthly Weight|"Certain loss for not engaging in daily self-weighing.
~Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis."
15876149|NCT03834194|Behavioral|Loss + Monthly Weight + Exercise|"Certain loss for not engaging in daily self-weighing.
~Incentives for gaining weight within a recommended (by Institute of Medicine) on a monthly basis.
~Incentives for meeting an exercise goal of 150 minutes of moderate physical activity per week, as recommended by the American College of Obstetricians and Gynecologists."
15876150|NCT03834181|Device|"Monitoring evaluation by connected devices: Wristband activity tracker Garmin Vivosmart® 3, Fora® Scale 550, Terraillon® Tensioscreen, Pulse oximeter Nonin® 3230, thermometer Fora® IR20b"|"All patients will be monitored before and after the bariatric surgery:
~During the preoperative preparation phase: weight, exercise, blood pressure and heart rate
~In the immediate post operative period: continuous monitoring of the heart rate with a telemetry system
~Prolonged follow-up: weight, exercise, blood pressure and heart rate"
15876151|NCT03834168|Other|standardized Study Diet|Standardized diet consisted with eucaloric meals with 4.5 gm of sodium per day for 5 days.
15876152|NCT03834155|Other|Hospital-based CR + Movn Application|Participants will be randomly assigned to a group that will receive hospital-based CR and access to the Movn mobile application.
15876153|NCT03834155|Other|Choice of Hospital or home-based CR + Movn Application|Participants will be randomly assigned to a group that has opportunity to opt in to hospital-based cardiovascular rehabilitation or home-based cardiovascular rehabilitation. All will have access to the Movn Application.
15876154|NCT03834155|Other|Hospital-based CR + Movn Application + Nudge|Participants will be randomly assigned to a group that will receive hospital-based CR and access to the Movn mobile application, plus encouraging nudge messages.
15876155|NCT03834155|Other|Choice of Hospital or home-based CR + Movn Application + Nudge|Participants will be randomly assigned to a group that has opportunity to opt in to hospital-based cardiovascular rehabilitation or home-based cardiovascular rehabilitation. All will have access to the Movn Application, plus encouraging nudge messages.
15876156|NCT03834142|Device|NSS-2 Bridge|The NSS-2 BRIDGE is a battery operated and disposable percutaneous auricular nerve field stimulator (Innovative Health Solutions, Versailles, IN, USA), that was recently cleared by the FDA and assigned a Class II Risk Designation; a class which includes surgical drapes, pumps and power wheelchairs. The indication for the NSS-2 BRIDGE is for the treatment of clinical symptoms related to opioid consumption and opioid withdrawal.
15876157|NCT03834129|Drug|Dexmedetomidine|Two administrations, before anesthesia and during surgery, by intravenous infusion of dexmedetomidine 1 μg/kg in 250 ml of physiological serum for 30 minutes
15876158|NCT03834129|Drug|sodium chloride 0.9%|Two administrations, before anesthesia and during surgery, by intravenous infusion of 250 ml of physiological serum for 30 minutes
15876159|NCT03834116|Device|Inspiratory muscle training|A pressure threshold device will be used to deliver IMT, which is commercially available by Phillips Respironics.
15876160|NCT03834103|Behavioral|Self-rehabilitation program and protein supplement|"Participants follow a home-based self-rehabilitation program consisting of the realisation of a set of physical exercises using an elastic band. The exercises have to be performed 3 times a week, and are associated with a protein supplementation.
~The rehabilitation follow-up by the physician is planned once a week, by phone, and with face-to-face appointments at inclusion, 6 weeks and 3 months follow-up."
15876161|NCT03834090|Device|rESWT|rESWT was administered once per week for 3 weeks using a ShockMaster 500 device with 1.8 bar pneumatic pressure, 10 Hz frequency, with 2000 pulses.
15876162|NCT03834090|Other|Supervised exercises|A program including post-isometric relaxation, and progressive resistance exercise (eccentric wrist extension) on the wrist extensors
15876163|NCT03834077|Other|Tissue flossing|Electrotherapy (transcutaneous electrical nerve stimulation) and Ultrasound in addition to tissue flossing.
15876164|NCT03834077|Other|Placebo comparator|Conventional physiotherapy in addition to flossing without tension
15876165|NCT03834064|Behavioral|Oral health promotion strategy|The proposed intervention is comprised of four components : (a) planned action including a behavioral contract Activity 1) with caregivers and action planning for oral health (Activity 2), (b) caregiver capacity building with didactic training (Activity 3), observational learning and caregiver practice (Activity 4); (c) environmental adaptations with location of oral health activities and reminder posters - physical environment (Activity 5) and administrative oral health support- (social environment (Activity 6); and (d) reinforcement with caregiver coaching (Activity 7).
15876166|NCT03834051|Drug|Fecal Microbiota Transplantation|Fecal Microbiota Transplantation Enema Open Label
15876167|NCT03834038|Drug|Lyophilized Fecal Microbiota Transplantation|Lyophilized FMT
15876168|NCT03834025|Behavioral|Phase 1 Condition 1|Providers assigned to this condition will be sent recruitment materials that are 'recruitment as usual' (Phase 1 Condition 1). These materials will not include prosocial messaging and will not include an additional mention of financial support available for participation.
15876169|NCT03834025|Behavioral|Phase 1 Condition 2|Providers assigned to this condition will be sent recruitment materials that include an additional mention of financial support available for participation, but will not include prosocial messaging (Phase 1 Condition 2).
15876170|NCT03834025|Behavioral|Phase 1 Condition 3|Providers assigned to this condition will be sent recruitment materials that include prosocial messaging, but do not include an additional mention of financial support available for participation (Phase 1 Condition 3).
15876171|NCT03834025|Behavioral|Phase 1 Condition 4|Providers assigned to this condition will be sent recruitment materials that include prosocial messaging and an additional mention of financial support available for participation (Phase 1 Condition 4).
15876172|NCT03834025|Behavioral|Phase 2 Condition 1|Providers who enroll in the study and are assigned to this condition will be in this group. Other than the opportunity to participate in a learning collaborative, participants receive no compensation.
15876173|NCT03834025|Behavioral|Phase 2 Condition 2|Providers who enroll in the study and are assigned to this condition will be in this group. In addition to the opportunity to participate in the learning collaborative, participants receive a reimbursement at 30% of the NC Medicaid rate for a patient visit.
15876174|NCT03834025|Behavioral|Phase 2 Condition 3|Providers who enroll in the study and are assigned to this condition will be in this group. In addition to the opportunity to participate in the learning collaborative, participants receive a reimbursement at 100 percent of the NC Medicaid rate for a patient visit for their time participating in the learning collaborative.
15876175|NCT03834012|Drug|Beclomethasone 800 µg per day|Intervention: Drug: Beclomethasone 800 µg HFA per day
15876176|NCT03834012|Drug|Placebo|Intervention: Drug: placebo
15876177|NCT03834012|Drug|Beclomethasone 400 µg per day|Intervention: Drug: Beclomethasone 400 µg HFA per day
15876178|NCT03834012|Drug|Beclomethasone 640 µg per day|Intervention: Drug: Beclomethasone 640 µg per day
15876179|NCT03833999|Drug|Ondansetron 8mg|ondansetron, a 5HT3 receptor antagonist used clinically in nausea and vomiting
15876180|NCT03833999|Diagnostic Test|abdominal MRI|serial MRIs on day 1 and day 3 of the study, at baseline and 2 hours apart 0-6 hours after meal ingestion on day 1 and 0-4 hours after the meal on day 3
15876181|NCT03833999|Drug|Lactulose|Participants will receive 20mls lactulose twice daily for 48 hours prior to the third study day
15876182|NCT03833999|Drug|Placebo oral capsule|overcoated placebo tablet, identical to the ondansetron
15876223|NCT03833635|Other|Sham|the sham intervention consists in a stable skin-to-skin contact with the participant
15876224|NCT03833622|Other|Shared Decision Aid Assessment|Provide feedback on a shared decision making tool to aid in discussion on goals of care in the emergency department
15876183|NCT03833986|Other|Stress management program|Nurses stress management program will be an experiential teaching program consisting of six sessions of stress management strategies for public health centers nurses. the workshop will be in a warm quite room with efficient light, temperature, and ventilation. The intervention group will receive handouts copies of the stress management program for each session at the end of the study.
15876184|NCT03833973|Behavioral|Overtraining Monitoring|Athletes will be thoroughly monitored (i.e. training workload, match activities or event/race performance, markers of inflammation and oxidative stress as well as cell-free DNA) throughout the season in order to establish novel biomarkers that could function as either predictors or diagnostic tools of overtraining.
15876185|NCT03833947|Drug|lignocaine+bicarbonate|ETT cuff was filled with mixture of 2% lignocaine with bicarbonate
15876186|NCT03833947|Drug|lignocaine+dexamethasone|ETT cuff was filled with mixture of 2% lignocaine with dexamethasone
15876187|NCT03833934|Diagnostic Test|Plasma Next Generation Sequencing (NGS)|Liquid biospys
15876188|NCT03833921|Drug|Abiraterone Acetate|1000 mg orally daily until disease progression
15876189|NCT03833921|Drug|Prednisone|5 mg oral low dose prednisone, twice daily
15876190|NCT03833908|Device|MAF-1217|Patients will be enrolled at screening (2 weeks before surgery), then will be randomized with a 1:1 ratio to 2 groups of 23 patients each: A. patients receiving MAF-1217 B. patients receiving just standard antibiotic therapy
15876191|NCT03833895|Drug|Norepinephrine|0.05ug/kg/min Norepinephrine during Cesarean Section Operation
15876192|NCT03833895|Drug|Phenylephrine|0.25ug/kg/min phenylephrine during Cesarean Section Operation
15876193|NCT03833895|Drug|Ringer's Solution|3 ml/kg/min of LR was administrated according to standard weight.
15876194|NCT03833882|Device|MAF1217|The study population will have to self-administer the study treatment in a TID posology.
15876195|NCT03833882|Other|Cationorm|The study population will have to self-administer the study treatment in a TID posology.
15876196|NCT03833869|Procedure|Assisted hatching|Controlled hatching of the zona pellucida in the laboratory prior to embryo transfer
15876197|NCT03833856|Procedure|colonoscopy perforation|The development of perforation after colonoscopy
15876198|NCT03833843|Diagnostic Test|imaging|ECG, Echocardiography and cardiac magnetic resonance imaging
15876199|NCT03833830|Diagnostic Test|Optical Coherence Tomography angiography (OCTA)|There will be an OCTA measurement (observational study) for both groups. Group allocation will be made due to previous anti-VEGF treatments (longterm treatment group >20 injections and shortterm treatment group < 5 injections).
15876200|NCT03833817|Behavioral|Talking about Cancer (TAC)|The TAC intervention is a six session intervention designed to teach the techniques of distress tolerance and communication skills in order to assist patients and their caregivers in discussing the patients' prognoses.
15876201|NCT03833804|Other|Processing of clinical notes in the EHR data collected during routine care|Clinical notes collected in the first day of hospital admission during usual care as input to natural language processing and machine learning algorithm.
15876202|NCT03833791|Behavioral|education and modifying diet|The control group maintains a sedentary lifestyle and is only subjected to follow a hypocaloric diet
15876203|NCT03833791|Behavioral|education, modifying diet and physical activity prescription|"One group, in addition to fulfilling a hypocaloric diet identical to the control group, is subjected to prescribe moderate physical activity.
~Other group, in addition to fulfilling a hypocaloric diet identical to the control and moderate group, is subjected to prescribe intense activity."
15876204|NCT03833778|Other|intervention group|The CED patients play the tablet-CED-quiz, while they wait for their doctor's appointment, so that gaps in the CED knowledge can be clarified during the doctor's consultation.
15876205|NCT03833765|Procedure|CAF+XCM|After flap elevation according to the Coronally Advanced Flap procedure for multiple recession defects, a Xenogeneic Collagen Matrix was applied and then covered by the flap.
15876206|NCT03833765|Procedure|CAF alone|Coronally Advanced Flap procedure alone was performed to treat multiple recession defects
15876207|NCT03833752|Diagnostic Test|Diagnostic Flexible Cystosocpy|Endoscopic Visualization of the Lower Urinary tract using either a flexible cystoscope for the purpose of aiding the establishment of a Urological Diagnosis.
15876208|NCT03833752|Diagnostic Test|Diagnostic Rigid Cystoscopy|Endoscopic Visualization of the Lower Urinary tract using either a rigid cystoscope for the purpose of aiding the establishment of a Urological Diagnosis.
15876209|NCT03833739|Device|Fixed appliance|
15876210|NCT03833726|Procedure|Experimental: LED group|5 Sessions of 8 minute 405 nm Blue Light Emitting Diode, LED, with a power of 1.66 W / m2, 7 days apart.
15876211|NCT03833726|Procedure|Sham Comparator: Control|5 Sessions of 8 minute with device off and heated gel, 7 days apart.
15876212|NCT03833713|Behavioral|SMS Dialogue|Once-weekly SMS dialogue sessions or micro-interventions and use behavior change techniques (BCTs) including self-monitoring with performance feedback and goal support
15876213|NCT03833713|Behavioral|SMS Assessments|Once-weekly SMS assessments of motor vehicle risks
15876215|NCT03833687|Device|Profhilo®|Profhilo® (IBSA Farmaceutici Italia S.r.l.) is a resorbable medical device 2.25 ml non-pyrogenic pre-filled syringe, containing 2 ml of 3.2% hyaluronic acid for intradermal use (32 mg H-HA + 32 mg L-HA dissolved in 2 ml of saline buffered sodium chloride.
15876216|NCT03833674|Other|Daily AIH Block|Daily sessions of AIH (dAIH) with use of short episodes of low oxygen (9% O2)
15876217|NCT03833674|Other|Sham dAIH Block|Daily sessions of sham dAIH which includes breathing room air (21% O2)
15876218|NCT03833674|Other|Respiratory Strength Training Block|Respiratory strength training using a hand-held device that resists inspiration or expiration.
15876219|NCT03833674|Other|AIH + Strength Training Block|AIH followed by respiratory strength training.
15876220|NCT03833661|Drug|M7824|Participants will receive an intravenous infusion of 1200 milligrams (mg) M7824 once every 2 weeks until confirmed disease progression, death, unacceptable toxicity or study withdrawal.
15876221|NCT03833648|Other|UControl Pain App with Education|The intervention will include educational information on pain management, e.g., using acetaminophen and NSAIDs to manage pain, as well as information on addiction and safe storage of medications.
15876225|NCT03833609|Behavioral|Online yoga training (Group A)|The yoga training program is a structured low-intensity Vishwas-Raj (18). This yoga program consists of stretching, strengthening, meditation and deep breathing, and has been shown to be effective among adults with RA. Participants will be asked to complete three individual 1-hour sessions per week for 12 consecutive weeks by watching a previously filmed session led by a qualified yoga instructor and posted on Facebook. They will also take part in a 1-hour virtual group session per week using a video-conferencing platform. Participants will also participate in weekly e-consultations with a research coordinator and discussions on Facebook with other participants.
15876226|NCT03833609|Behavioral|Online aerobic dance training (Group B)|The aerobic dance program is a low to moderate intensity level program and will also use a video. The video, adapted for youth with JIA, was developed with feedback from a JIA patient with experience in aerobic dance and a physiotherapist with experience in pediatric rheumatology. The aerobic dance program will have the same characteristics in terms of frequency, total number of sessions and total duration as the yoga program (i.e., three 1-hour individual sessions and one 1-hour virtual group session per week for 12 weeks). Participants will also participate in weekly e-consultations with a research coordinator and discussions on Facebook with other participants.
15876227|NCT03833596|Drug|Prednisone|All 3 arms will receive Prednisone - 2 will be standard course treatment, 1 will be short course and rapidly-tapered
15876228|NCT03833596|Dietary Supplement|Exclusive Enteral Nutrition|2 arms will receive EEN, in concurrence with either regular-course or short course and rapidly-tapered CS.
15876229|NCT03833583|Device|Soterix Medical mini-CT tDCS stimulator|"Patients will have two electrodes applied (one anode, one cathode) administering active (real) or sham (placebo, not real) tDCS stimulation.
~Stimulation will last 20 minutes per day, three days per week, for 5 weeks"
15876230|NCT03833570|Dietary Supplement|Rapid Release Capsules Melatonin, 10 mg|Melatonin is a dietary supplement which is naturally produced in the body and closely involved in the natural sleep cycle. recently topical and systemic melatonin supplements. have been proposed as a new therapeutic modality for oral mucositis due to its anti-cancer, anti-inflammatory, and anti-oxidant effects.
15876231|NCT03833570|Drug|Miconaz oral gel|Antifungal agent
15876232|NCT03833570|Drug|BBC oral spray|Topical anesthetics and anti-inflammatory agent
15876233|NCT03833570|Drug|Oracure gel|Topical analgesic gel
15876234|NCT03833570|Other|Alkamisr sachets|Sodium bicarbonate mouthwash
15876235|NCT03833557|Procedure|Nanohydroxyapatite Pulpotomy|Biphasic calcium phosphate 500-1000 Um Straumann BoneCeramic
15876236|NCT03833557|Procedure|MTA pulpotomy|Angleus grey MTA
15876237|NCT03833557|Procedure|Formocresol Pulpotomy|Buckley's Fromocresol. diluted full strength foromocresol
15876238|NCT03833544|Other|Exercise training|Progressive resistance training of hip, knee, and ankle flexors.
15876239|NCT03833531|Behavioral|ImRS|ImRs is a PTSD treatment that specifically addresses the troubling memories of the traumatic event and the personal meaning of the event and consist of 12 to 18 sessions in maximum 6 months.
15876240|NCT03833531|Behavioral|SFT|SFT is a treatment for personality disorders that takes at least one group-session per week, for the duration of one year.
15876241|NCT03833518|Other|Rehabilitation using motorized glove for stroke and spinal cord injury|Individuals with hand impairment due to stroke or spinal cord injury will wear a motorized glove (Gloreha Sinfonia), or exoskeleton, as part of a rehabilitation protocol to improve dexterity. For each exercise, participants will attempt to do the action, receiving assistance as necessary via powered motors that can move each finger through its passive range of motion based on the current and target position.
15876242|NCT03833518|Other|Functional MRI for stroke and spinal cord injury|All participants will undergo 3 functional MRI's (fMRI's), two at the beginning of the experiment to document brain activity related to movement intention and ability to sense movement. A third MRI will be performed after the rehabilitation is completed to document the change in brain activity related to movement intention and ability to sense movement.
15876243|NCT03833518|Other|Transcranial magnetic stimulation (TMS) for stroke and spinal cord injury|Stimulation of the nervous system may be performed using a magnetic stimulator. TMS of the central nervous system is optional. Whether or not a participant undergoes TMS will depend upon their consent, their eligibility for TMS (i.e. no seizure history), and their neurological response to TMS.
15876244|NCT03833505|Other|Bitestrip|The parents of the patients were asked to complete a survey that included questions about the demographic data, medical history of the patient, clinical findings of E. For diagnosis of sleep bruxism, a single-use BiteStrip® device (Up2dent, Inc.), including an electromyographic electrode, small display screen and lithium cell, was used to record the increased electromyographic activity of the masticatory muscles during sleep and bruxism, other harmful oral habits, family life and habits.
15876245|NCT03833492|Behavioral|Underwater EMR|Polypectomy is performed under full water emersion without the use of submucosal injection.
15876246|NCT03833479|Other|No Further Treatment|No further treatment
15876247|NCT03833479|Drug|TSR-042|Fixed 500 mg TSR-042 dose Q3W for the first 4 doses followed by a fixed 1000 mg TSR-042 dose Q6W for up to 24 months
15876248|NCT03833466|Drug|metformin and chemotherapy|"Drug: Metformin Metformin is orally administered as 500mg bid for 7 days and escaladed to 500mg tid if adverse events are tolerated.
~Drug: Cisplatin Cisplatin is given at 75mg/m2 intravenously on day 1 of each 21 day cycle.
~Drug: Paclitaxel Paclitaxel is given at 175mg/m2 intravenously on day 1 of each 21 day cycle."
15876249|NCT03833453|Behavioral|EMDR|EMDR is a PTSD treatment that specifically addresses troubling memories of and the personal meaning of the traumatic event and consists of 12 to 18 sessions in a maximum of 6 months.
15876250|NCT03833453|Behavioral|DBT|DBT is a treatment for personality disorders (PD) focused on emotion regulation. It takes at least one group-session per week, and one individual coaching session every two weeks, for the duration of one year.
15876251|NCT03833440|Drug|Durvalumab (MEDI4736)|"1500 mg, every 4 weeks. CxD1 for each cycle, 1 cycle = 28 days
~EXCEPT FOR CYCLE 1 IN ARM C : at C1D8 and cycle 1 = 35 days
~c=cycle D= day"
15876252|NCT03833440|Drug|Monalizumab (IPH2201)|"1500 mg, every 4 weeks. CXD1 for each cycle, 1 cycle = 28 days
~c=cycle D= day"
15876253|NCT03833440|Drug|Oleclumab (MEDI9447)|"3000 mg every 2 week x 4 doses, followed by 3000 mg every 4 weeks. C1D1, C1D15, C2D1, C2D15 and CXD1 for the orther cycles, 1 cycle = 28 days.
~c=cycle D= day"
15876254|NCT03833440|Drug|Ceralasertib (AZD6738)|"240 mg bid in Cycle 1, Days 1-7, followed by 7 days on treatment in each cycle between Days 22 and 28.
~CxD22-D28 for each cycle, 1 cycle = 28 days EXCEPT FOR CYCLE 1 : at C1D1,C1D29 and cycle 1 = 35 days
~c=cycle D= day"
15876255|NCT03833440|Drug|DOCETAXEL|"75 mg/m2, every 3 weeks. CxD1 for each cycle, 1 cycle = 21 days
~c=cycle D= day"
15876256|NCT03833427|Drug|Selumetinib|Selumetinib oral capsules administered BID at escalating dose levels. Selumetinib administered only in weeks 1&2 of each 3-week treatment cycle.
15876257|NCT03833427|Biological|Pembrolizumab|Pembrolizumab administered by IV infusion at 200 mg Q3W, given on cycle day 1 of each 3-week treatment cycle.
15876258|NCT03833414|Procedure|triceps lifting and olecranon osteotomy approaches|two different surgical approaches for distal humerus fracture
15876259|NCT03833401|Procedure|Autologous tissue transplantation|Root canal disinfection and revascularization with patient's own minced pulp tissues
15876260|NCT03833401|Procedure|Root canal revascularization|Root canal disinfection and revascularization without tissue transplantation
15876261|NCT03833388|Drug|TOP1630 0.1% Ophthalmic Solution TID OU|Bilateral ocular drug administration
15876262|NCT03833388|Drug|Placebo to TOP1630 0.1% Ophthalmic Solution TID OU|Bilateral ocular drug administration
15876263|NCT03833375|Other|Decision Aid|Shared-decision making tool
15876264|NCT03833362|Drug|Narlaprevir|yellow film-coated 100 mg. tablets
15876265|NCT03833362|Drug|Ritonavir|100 mg tablets encapsulates in gelatin capsules (for blinding purposes)
15876266|NCT03833362|Drug|Placebo Narlaprevir|yellow film-coated 100 mg. tablets identical to Narlaprevir tablets
15876267|NCT03833362|Drug|Placebo Ritonavir|100 mg lactose/ cellulose tablets encapsulated in gelatin capsules (for blinding purposes) identical to Ritonavir capsules
15876268|NCT03833362|Drug|Pegylated interferon alfa-2a/ Pegylated interferon alfa-2b|180µg for subcutaneous injections in 0.5 ml syrettes / 1.5 µg/kg for subcutaneous injections in 50µkg, 80µkg,100µkg, 120µkg, 150µkg in vials
15876269|NCT03833362|Drug|Ribavirin|"hard gelatin, white 200mg. capsules
~Weight-based dose was 1000 mg/day (patient weight <75 kg) or 1200 mg/day (patient weight ≥75 kg) with Peginterferon alfa-2a and 800 mg/day (patient weight <65 kg) - 1400 (patient weight >105 kg) mg/day with Peginterferon alfa-2b"
15876270|NCT03833349|Behavioral|Spinning Class|Spinning Class twice a week for six weeks.
15876271|NCT03833349|Behavioral|Yoga Class|Yoga Class twice a week for six weeks.
15876272|NCT03833349|Behavioral|Dance Class|Dance Class twice a week for six weeks.
15876273|NCT03833336|Other|Placebo|The group assigned to placebo will receive an infusion of normal saline solution plus oral lactose capsules identical to oral medication.
15876274|NCT03833336|Drug|Ferric carboxymaltose|The group assigned to receive intravenous iron will receive intravenous ferric carboxymaltose ajusted by weight and Hb levels according to study protocol plus oral placebo
15876275|NCT03833336|Drug|Ferroglycine Sulfate|One group assigned to receive oral iron will receive two 100 mg oral capsule of ferroglycine sulfate plus intravenous placebo (normal saline solution)
15876276|NCT03833336|Drug|Sucrosomial Iron|One group assigned to receive oral iron will receive or two oral capsule containing 30 mg of pyrophosphate sucrosomial iron plus intravenous placebo (normal saline solution)
15876277|NCT03833323|Combination Product|Implantable System for Remodulin (treprostinil)|All patients will be implanted with the Implantable System for Remodulin (treprostinil).
15876278|NCT03833310|Diagnostic Test|Osteoprotegerin marker in serum in inflammatory bowel disease|I will measure Osteoprotegerin and Soluble Receptor activator of nuclear factor kappa-Β ligand markers in serum of patient with inflammatory bowel disease
15876279|NCT03833297|Drug|Drugs inducing hepatological toxicity|Drugs susceptible to induce hepatological toxicities
15876280|NCT03833284|Behavioral|Participant Barriers to TVU Screening|Workshops tailored toward patients to increase knowledge about TVU screening guidelines and benefits.
15876281|NCT03833284|Behavioral|Provider Barriers to TVU Screening|Workshops tailored toward providers to increase knowledge about TVU screening guidelines and benefits.
15876282|NCT03833271|Biological|Influenza vaccine, Immune function|Comparing immune function and seroconversion after immunizing healthy children and juvenile idiopathic arthritis (JIA) children treated with different type of medication with influenza vaccine.
15876283|NCT03833258|Behavioral|Rehabilitation with no precautions|Patients will recover from total hip replacement surgery being guided by pain only and not by the precautions imposed upon them by clinicians.
15876284|NCT03833245|Behavioral|Patient Navigation|The patient navigation (PN) intervention will initiate following participant recruitment. It is important to note that PN sessions do not strictly coincide with specific weeks of pregnancy since the women can be recruited up to ≤25 weeks of gestation. The prenatal portion of the intervention includes 10 sessions delivered within approximately 14 weeks. The postnatal portion of the intervention will be delivered as 4 sessions over 8 weeks. Women who complete the intervention before delivery will receive regular calls/texts until delivery wherein the navigator will encourage and reinforce abstinence and treatment retention. All contact will be reported by staff in a patient contact log developed for the study that will be used to quantify level of patient contact.
15876285|NCT03833232|Device|omentopexy with cyanoacrilate glue|apposition of omentum with cyanoacrilate glue on gastric section
15876286|NCT03833219|Behavioral|Weekly feedback|Send push notification reporting user's handheld phone use while driving compared to distribution for driver cohort (age, geographic area) each week.
15876287|NCT03833219|Behavioral|End of intervention period incentive|Notify participant about potential incentive at the end of the intervention period, but do not provide weekly feedback about performance.
15876288|NCT03833219|Behavioral|Loss-framed weekly incentive|Send push notification reporting user's handheld phone use while driving compared to distribution for driver cohort (age, geographic area) each week. Pay participant weekly according to where they fall on the distribution each week.
15876289|NCT03833206|Drug|PDC-1421 Capsule|PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient.
15876290|NCT03833193|Radiation|Hypofractionated radiotherapy|Radiation: Hypofractionated radiotherapy at 3Gy/f
15876333|NCT03832842|Diagnostic Test|Blood sample|Blood sample
15876294|NCT03833154|Drug|Durvalumab|Durvalumab 1500 mg every 4 weeks [q4w] intravenously [iv] for up to 24 months or until progression or other discontinuation criteria are met.
15876295|NCT03833154|Other|Placebo|Matching placebo for infusion every 4 weeks iv for up to 24 months or until progression or other discontinuation criteria are met.
15876296|NCT03833154|Radiation|SBRT|Delivered in 3, 4, 5 or 8 fractions.
15876297|NCT03833154|Radiation|SBRT|Delivered in 3, 4, 5 or 8 fractions.
15876298|NCT03833141|Other|Survey Administration|Patient Reported Outcomes (PROs) of health, quality of life, and economic outcomes during routine clinical practice.
15876299|NCT03833128|Drug|Low Dose REN001|Oral
15876300|NCT03833128|Drug|High Dose REN001|Oral
15876301|NCT03833115|Other|vaginal gel containing or not sodium lauryl sulfate|Prevention
15876302|NCT03833102|Other|biological analysis|ST types will be determined for all individualized bacterial strains. For all the bacterial strains, RNAs expression will be analyzed at three different growth phases: early exponential phase, mid exponential phase and early stationary phase. Expression of RNAIII and SprD will be evaluated by quantitative polymerase chain reaction.
15876303|NCT03833089|Combination Product|Targeted serum potassium level|In the following order, following advices end prescriptions will be provided: 1) Potassium rich dietary advice, 2) Potassium supplementation, 3) mineralocorticoid receptor antagonists,
15876304|NCT03833076|Device|Medical device Procto|Medical device Procto presents itself as a translucent green gel with a typical smell.
15876305|NCT03833076|Device|Matching placebo|IP placebo presents itself as a translucent green gel with a typical smell.
15876306|NCT03833063|Drug|botulinum toxin A|glabellar injections with botulinum toxin A
15876307|NCT03833063|Drug|Placebos|glabellar injections with sodium chloride
15876308|NCT03833037|Other|Soft tissue sarcomas in adults|Adult sinovial sarcoma
15876309|NCT03833024|Drug|Micronized Purified Flavonoid Fraction|After randomization (1:1 with stratification by centre) patients will receive 1000 mg of oral MPFF (Venixxa, one 500mg tablet BID) for 6 months, in addition to their usual PTS and DVT treatment
15876310|NCT03833024|Drug|Placebo|After randomization (1:1 with stratification by centre) patients will receive an oral placebo (one tablet BID) for 6 months, in addition to their usual PTS and DVT treatment
15876311|NCT03833011|Procedure|Osteopathic Manipulation|Osteopathic manipulation
15876312|NCT03832998|Drug|Erenumab Dose 1|Subjects in the low body-weight group at day 1 and who are randomized to Dose Level 1 will receive this dose.
15876313|NCT03832998|Drug|Erenumab Dose 2|Subjects in the low body-weight group at day 1 who are randomized to Dose Level 2 and subjects in the high body-weight group at day 1 who are randomized to Dose Level 1 will receive this dose.
15876314|NCT03832998|Drug|Erenumab Dose 3|Subjects in the high body-weight group at day 1 who are randomized to Dose Level 2 will receive this dose.
15876315|NCT03832998|Other|Placebo|Placebo matching dose for erenumab dose 1, 2 and 3.
15876316|NCT03832985|Genetic|Receive an adult-onset result|Assess the psychosocial outcomes and the lived experience of MyCode pediatric participants and parents who have received an adult-onset genomic result.
15876317|NCT03832985|Genetic|Receive a pediatric-onset result|Assess the psychosocial outcomes and the lived experience of MyCode pediatric participants and parents who have received an adult-onset genomic result.
15876318|NCT03832985|Genetic|Control - No Result|Assess the psychosocial outcomes and the lived experience of MyCode pediatric participants and parents who have not received an adult-onset genomic result.
15876319|NCT03832972|Other|estrogen level|Women are tested at different times in their menstrual cycle, if there is a cohesion between performance and level of estrogen
15876320|NCT03832959|Device|EnsoETM|The EnsoETM is a device with a esophageal probe that can provide temperature adjustment
15876321|NCT03832946|Drug|GB0139|GB0139 is a galectin-3 inhibitor designed to modulate the fibrogenic response to tissue injury. It is administered as inhalation once a day.
15876322|NCT03832946|Drug|Placebo|Placebo is administered as inhalation once a day
15876323|NCT03832933|Behavioral|High Protein Diet|16 week weight loss and 36 weight loss maintenance intervention. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 32%:40%:28%.
15876324|NCT03832933|Behavioral|Standard Protein Diet|16 week weight loss and 36 weight loss maintenance intervention. Approximate macronutrient distributions (carbohydrate:protein:fat) will be 53%:21%:25%.
15876325|NCT03832920|Other|Analgesia Nociception Index|A monitor of nociception for patients under general anesthesia
15876326|NCT03832907|Device|Dexcom G6 CGM - Continues Glucose Monitoring sensor system|A blinded factory-calibrated continues glucose monitoring sensor system Dexcom G6 will be placed shortly after admission. Two CGM devices will be inserted in all patients - one in the abdomen and one in the arm to also assess differences in blood glucose readings between upper extremity and abdominal insertion sites. Information on CGM readings will be collected daily during the hospital stay and after hospital discharge for 10 days using the Dexcom Studio software to download the Dexcom receiver data.
15876327|NCT03832907|Diagnostic Test|POC BG - Point-of-Care Blood Glucose monitoring|Standard of care - bedside point-of-care (POC) capillary blood glucose (BG) monitoring will be done before meals and bedtime daily during the hospital stay and after hospital discharge for 10 days.
15876328|NCT03832894|Drug|Estradiol Valerate|Oestradiol supplementation starting from day of trigger through out the luteal phase
15876329|NCT03832881|Diagnostic Test|ADAMTS13, VWF assay|
15876330|NCT03832868|Behavioral|Pre-visit timing of receipt of the ICDs implantation decision aid|The intervention is the timing of receipt of the decision aid. The decision aid is designed to facilitate informing patients and helping to reach a decision.The implantable cardioverter-defibrillators (ICDs) implantation decision aid presents treatment options, risks, and benefits in lay terms.It is currently utilized in all of the Emory cardiac electrophysiology clinics as part of usual clinical care.
15876331|NCT03832868|Behavioral|Post-visit timing of receipt of the ICDs implantation decision aid|The intervention is the timing of receipt of the decision aid. The decision aid is designed to facilitate informing patients and helping to reach a decision.The implantable cardioverter-defibrillators (ICDs) implantation decision aid presents treatment options, risks, and benefits in lay terms.It is currently utilized in all of the Emory cardiac electrophysiology clinics as part of usual clinical care.
15876332|NCT03832855|Biological|pING-hHER3FL|Plasmid vaccine containing HER3
15876334|NCT03832829|Device|Indirect composite restoration|Restoration of tooth with extensive substance loss
15876335|NCT03832816|Drug|Placebo|Placebo vapor (distilled water)
15876336|NCT03832816|Drug|Vaporized THC alone|Acute exposure to vaporized THC
15876337|NCT03832816|Drug|Vaporized CBD alone|Acute exposure to vaporized CBD
15876338|NCT03832816|Drug|Vaporized CBD with THC|Acute exposure to vaporized CBD with THC
15876339|NCT03832803|Behavioral|Empty bladder|No drinking protocol.
15876340|NCT03832803|Behavioral|Full bladder|Followed drinking protocol
15876341|NCT03832790|Other|observation|observation
15876342|NCT03832777|Device|Repetitive Transcranial Magnetic Stimulation|Subjects will receive both active and placebo rTMS, in a crossover modality.
15876343|NCT03832764|Device|ANSPEC-PRO|Device monitors for 140 minutes continuously the pain levels in awake patients in PACU/ICU
15876344|NCT03832751|Other|skin biopsy before and after NB-UVB phototherapy|skin biopsy before and after NB-UVB phototherapy to measure tissue human beta-defensin 1
15876345|NCT03832738|Drug|JTE-451 Tablets|Active drug tablets containing JTE-451
15876346|NCT03832738|Drug|Placebo Tablets|Placebo tablets matching in appearance to the active drug tablets
15876347|NCT03832725|Other|High Protein (HP) weight loss diet|"Newly diagnosed Type 2 Diabetic (NT2DM) subjects will be placed on a HP diet for 6 months with all food provided for weight loss and remission of NT2DM.
~Intervention with the HP diet will be 6 months. If subjects have not had remission of Type 2 Diabetes by the end of the 6 months, they will be referred to an endocrinologist for pharmaceutical treatment"
15876348|NCT03832725|Other|High carbohydrate (HC) weight loss diet|"Newly diagnosed Type 2 Diabetic (NT2DM) subjects will be placed on a HC diet for 6 months with all food provided for weight loss and remission of NT2DM.
~Intervention with the HP diet will be 6 months. If subjects have not had remission of Type 2 Diabetes by the end of the 6 months, they will be referred to an endocrinologist for pharmaceutical treatment"
15876349|NCT03832712|Procedure|Deep Brain Stimulation|Surgical implantation of intracranial leads for deep brain stimulation, extension cables and implantable pulse generator
15876350|NCT03832712|Drug|Best Medical Treatment|Unselective β-blockers such as Propanolol
15876351|NCT03832699|Drug|Dydrogesterone 10 MG|Oral progesterone 10 mg TID
15876352|NCT03832699|Drug|Endometrin 100Mg Vaginal Insert|Vaginal Endometrin 100 mg twice daily
15876353|NCT03832686|Other|Virtual Coach|The smartphone application, tailored to patients with HNC, will monitor patient progress while also providing a direct line to health care providers should any questions or concerns arise concerning their treatment. The mobile application will also feature instructional videos that describe the swallowing exercises in detail, providing patients with another resource to help improve their overall rehabilitation experience. Finally, home practice reminders and prompts will be used to help patients integrate the exercises into their daily routine.
15876354|NCT03832673|Drug|Pembrolizumab|Pembrolizumab 200 mg IV every 3 weeks (for 3 cycles)
15876355|NCT03832673|Drug|Epacadostat|Epacadostat 300 mg (BID) orally continuously every 28 days (for 3 cycles)
15876356|NCT03832660|Behavioral|Lifestyle|A 4-month lifestyle intervention will consist of two integrated components i.e. physical activity and dietary supplementation with inorganic nitrate. The physical activity component aims to increase daily physical activity level by at least 2000 steps/day from baseline (e.g. walking for approximately 30 minutes), at least 5-7 days per week. The second component of the lifestyle intervention is a dietary supplementation with inorganic nitrate. A single dose of inorganic nitrate given in the form of concentrated nitrate-rich beetroot juice (NO3-, BEET IT Sport, James White Drinks Ltd., Ipswich, UK) containing 6 mmol of NO3- in 70 ml bottle.
15876357|NCT03832660|Drug|Sacubitril/Valsartan|Angiotensin receptor neprilysin inhibitor Sacubitril / Valsartan: The treatment period begins on day 1 with initial dosing of sacubitril/valsartan, followed by uptitration every 2 to 4 weeks to the target dose of 97/103 mg twice daily. 3 doses of sacubitril/valsartan available throughout the study are 24/26 mg, 49/51 mg, and 97/103 mg, each taken by mouth twice daily. If the patient discontinues the study medication, the patient is advised to return to the clinic for an end-of-study visit. Patients undergo treatment for 4 months.
15876361|NCT03832634|Diagnostic Test|Fetal Genome Profiling.|Once pregnancy is achieved, patients will undergo non-invasive collection of trophoblast cells (trophoblast retrieval and isolation from the cervix, TRIC) at an early gestational age, approximately 5-6 weeks. The patient will also be screened with blood work for carrier status for genetic conditions.
15876362|NCT03832621|Drug|Temozolomide|temozolomide 150 mg/sqm daily on days 1-5 every 4 weeks
15876363|NCT03832621|Drug|Nivolumab|nivolumab 480 mg i.v. every 4 weeks
15876364|NCT03832621|Drug|Ipilimumab|low-dose ipilimumab 1 mg/Kg i.v. every 8 weeks
15876365|NCT03832608|Other|No intervention|There is not intervention to be administered, only collection of data through various tests and questionnaires.
15876366|NCT03832595|Other|Intervention Arm|"An EHR in-basket message will be sent to the patient's PCP which identifies the patient's high-risk CKD status and indicates that the patient will receive:
~Nephrologist led electronic consultation: review of the patient's EHR with recommendations sent to the PCP every ~6 months,
~Medication therapy management: PharmD led telephonic medication therapy management with the patient every ~6 months,
~and Nurse led CKD patient education, every ~6-12 months
~unless the PCP opts the patient out of the interventions (by responding to the EHR in-basket message and providing an opt-out reason or requesting an office consultation with nephrology)."
15876367|NCT03832595|Other|Usual Care|Patients in the usual care arm will continue to receive CKD care guided by their PCPs as per usual care practices (i.e., specialty consultation, pharmacotherapy, nurse education, etc. may be ordered by the PCP according to their usual practice).
15876368|NCT03832582|Drug|Annexin|All patients will undergo a 99mTc-annexin V-128 scintigraphy (SPECT)
15876369|NCT03832569|Drug|Pembrolizumab|Pembrolizumab 200 mg IV every 3 weeks over 30 minutes.
15876370|NCT03832556|Other|CT scan|CT scan with biphasic injection of contrast product
15876371|NCT03832556|Other|MRI examination|MRI with injection of contrast
15876593|NCT03830827|Drug|Vortioxetine|8-week 10-20mg/day vortioxetine; 2-hour MBRP intervention per week in 8 weeks
15876372|NCT03832530|Behavioral|Safer conception counseling inclusive of periconception PrEP|Observational evaluation of factors associated with uptake of and adherence to daily, oral TDF/FTC PrEP and other safer conception methods (including: CHCT, ART for the infected partner, and uptake of contraception for those who decide not to conceive during follow-up) over 9 month. Maximum 19 month follow-up period (through pregnancy outcome).
15876373|NCT03832517|Drug|Single intravenous doses of RC-01|Intravenous single escalating doses of RC-01
15876374|NCT03832517|Drug|Single intravenous doses of placebo|Intravenous single doses of placebo to match RC-01
15876375|NCT03832517|Drug|Multiple intravenous doses of RC-01|Multiple ascending doses of RC-01 given intravenously two or three times daily for 10 days
15876376|NCT03832517|Drug|Multiple intravenous doses of placebo|Multiple doses of placebo to match RC-01 given intravenously two or three times daily for 10 days
15876377|NCT03832504|Other|No intervention|The participant will rest in a seated position.
15876378|NCT03832504|Other|Fan|A fan placed in front of the participant will provide an airflow of 4 m/s throughout the exposure.
15876379|NCT03832504|Other|Skin Wetting|Tap water (~18°C) will be applied every 5 minutes to the face, neck, upper and lower arms and upper and lower legs using a spray bottle.
15876380|NCT03832504|Other|Fan + Skin wetting|A fan placed in front of the participant will provide an airflow of 4 m/s throughout the exposure. In addition, tap water (~18°C) will be applied every 5 minutes to the face, neck, upper and lower arms and upper and lower legs using a spray bottle.
15876381|NCT03832491|Other|Home based therapy|Airway clearence techniques
15876382|NCT03832491|Other|Game and home based therapy|Game based approach programme and airway clearence techniques
15876383|NCT03832478|Device|Virtual Reality Headset Given|Samsung Gear VR Headset with guided mindfulness meditation app
15876384|NCT03832465|Drug|Levofloxacin film-coated tablet|"50 participants are randomly assigned to receive intraluminal eradication of H. pylori.
~with medicaments containing levofloxacin powder or levofloxacin solution."
15876385|NCT03832465|Drug|Levofloxacin intravenous solution|"50 participants are randomly assigned to receive intraluminal eradication of H. pylori.
~with medicaments containing levofloxacin powder or levofloxacin solution."
15876386|NCT03832452|Drug|Lucerastat (Treatment A)|2000 and 4000 mg; hard capsules for oral administration
15876387|NCT03832452|Other|Placebo|hard capsules for oral administration
15876388|NCT03832452|Drug|Moxifloxacin|400 mg; film-coated tablets for oral administration
15876389|NCT03832452|Drug|Lucerastat (Treatment B)|1000 mg; hard capsules for oral administration
15876390|NCT03832452|Drug|Lucerastat (Treatment C)|4000 mg; hard capsules for oral administration
15876391|NCT03832439|Dietary Supplement|Probiotic|Lactobacillus rhamnosus GG 10 billion cells and microcrystalline cellulose
15876392|NCT03832439|Dietary Supplement|microcrystalline cellulose|Placebo
15876393|NCT03832426|Drug|Narlaprevir|100 mg film-coated tablets
15876394|NCT03832426|Drug|Ritonavir|100 mg film-coated tablets
15876395|NCT03832413|Diagnostic Test|DELPhI (TMS-EEG analysis)|We perform an evaluation not an intervention. the DELPhI evaluation comprises of an automated analysis to EEG data recorded during TMS (Transcranial Magnetic Stimulation) to the M1L (Primary motor cortex).
15876396|NCT03832400|Biological|MET-2|MET-2 is a defined consortium of human commensal bacteria derived from a healthy donor, which has the full metabolic functional capacity of fecal microbiota.
15876397|NCT03832400|Drug|Placebo oral capsule|Placebo oral capsule which is identical to the MET-2 capsules.
15876398|NCT03832387|Device|Non-invasive mechanical ventilation|
15876399|NCT03832387|Device|Continuous positive airway pressure|
15876400|NCT03832387|Device|Venturi mask|
15876401|NCT03832387|Device|Reservoir mask|
15876402|NCT03832374|Other|Descriptive|
15876403|NCT03832361|Drug|IMGN853|IMGN853 6 mg/kg intravenously every 3 weeks until disease progression
15876404|NCT03832348|Device|PET scan imaging|3 PET scans will be performed after each 3 first infusions of Pembrolizumab
15876405|NCT03832335|Diagnostic Test|Measurement of aniseikonia tolerance|Adding sizeglasses of different percent before right and left eye and measure the impact on stereopsis
15876406|NCT03832322|Procedure|Water exchange colonoscopy|During back-to-back colonoscopy, the first examination was completed with water exchange during insertion and CO2 insufflation during withdrawal. The second examination was completed with CO2 insufflation during both the insertion and withdrawal.
15876407|NCT03832322|Procedure|CO2 insufflation colonoscopy|During back-to-back colonoscopy, the first examination was completed with CO2 insufflation during both the insertion and withdrawal. The second examination was also completed with CO2 insufflation during both the insertion and withdrawal.
15876408|NCT03832309|Behavioral|Do we speak to them in a way that convinces them to have the dream|During induction, and depending on what group they are randomized to, the physician will speak to them about having a dream while on the drug
15876409|NCT03832309|Behavioral|Speaking to them as a regualar person|During induction, if the patient is in group 1, the resident performing procedural sedation will remind the patient about what the patient wanted to dream and ask them to focus on that as the ketamine is being administered. If the patient is in group 2, the resident performing procedural sedation will give no specific instruction to the patient at this point.
15876410|NCT03832296|Behavioral|Weight-Loss Maintenance|Over the course of the first 6-months, participants will build their self-efficacy to maintain weight loss on their own, empowered to do what is needed to achieve personal goals and long-term behavior change (months 7-18). The first 6 months of I-CAN will prepare participants for successful independent weight-loss maintenance in months 7-18. During the 12-month independent weight-loss maintenance phase participants exercise on their own and maintain their weight loss (or increase weight loss if they choose) with the only contact from interventionists being two newsletters at months 9 and 15.
15876411|NCT03832296|Behavioral|Health Education (Attention Control)|Participants in the control group will attend an individual session during month 1, and a monthly face-to-face group meeting during months 2-6. The sessions will provide attention, social interaction, and physician-based health education. Participants will receive a newsletter during months 9 and 15.
15876591|NCT03830866|Drug|Carboplatin|For patients enrolled under CSP v2 and prior - platinum based Standard of Care Chemotherapy administered concurrent with radiation therapy
15876412|NCT03832283|Diagnostic Test|CAD-MDD/CAT-DI screening via MyChart|Patients will receive invitations via MyChart to complete the CAD-MDD to screen for major depressive disorder (MDD). For patients who screen positive for MDD, CAT-DI will launch automatically and assess depression severity. CAT-DI assigns a score of 0 to 100 in four severity categories (<50=normal, 50 to 65=mild, 66 to 75=moderate, and >75=severe).
15876413|NCT03832283|Diagnostic Test|CAD-MDD/CAT-DI screening during clinic visit|During routine in-clinic visits, medical assistants or providers will ask patients to complete the CAD-MDD to screen for major depressive disorder (MDD). For patients who screen positive for MDD, CAT-DI will launch automatically and assess depression severity. CAT-DI assigns a score of 0 to 100 in four severity categories (<50=normal, 50 to 65=mild, 66 to 75=moderate, and >75=severe).
15876414|NCT03832283|Other|CAT-DI monitoring via MyChart|Patients with active MDD will receive invitations via MyChart to complete the CAT-DI to assess MDD severity and remission. A normal CAT-DI score (<50) will indicate that a patient's MDD is in remission.
15876415|NCT03832283|Other|PHQ-9 monitoring during clinic visits|During routine in-clinic visits, medical assistants or providers will ask patients to complete the PHQ-9 to assess MDD severity and remission. A PHQ-9 score < 5 will indicate that a patient's MDD is in remission.
15876416|NCT03832270|Behavioral|Parents InC|Based on social learning theory, Parents InC has been designed specifically for parents of children with an ADHD diagnosis with a particular focus on parenting sense of self competence.
15876417|NCT03832270|Behavioral|Incredible Years|Also based on social learning theory but focus is not specifically on ADHD.
15876418|NCT03832257|Other|ECHO CT Intervention|weekly video conference between hospitalist and skilled nursing facilities
15876419|NCT03832257|Other|Matched Non-Participating Facilities|Matched Non-Participating Facilities
15876420|NCT03832244|Diagnostic Test|Sub-mental ultrasonography|Sub-mental ultrasonography including tongue-base thickness, retropalatal distance and the distance between lingual arteries
15876421|NCT03832231|Device|Shear Wave Elastography|Ultrasound technology to assess tissue stiffness
15876422|NCT03832218|Diagnostic Test|Psychiatric assessment|"Psychiatric assessment and neuropsychological tests
~Test : Wechsler Intelligence Scale for Children (WISC-V)
~Test :Behavior Rating Inventory of Executive Function (BRIEF) : BRIEF-Parents, BRIEF-Teacher
~Global Assessment of Functioning Scale
~Scale : Brief Psychiatric Rating Scale (BPRS)
~Test : Children Depression Inventory (CDI)
~Scale : Revised-Children's Manifest Anxiety Scale (R-CMAS)
~Survey : Pediatric Quality of Life Inventory Version 4.0 (PedsQL™ 4.0)
~Scale : Conners' scale (parents and teachers)"
15876423|NCT03832205|Device|Capaciflector monitoring|Non-invasive capaciflector monitoring of respiratory rate and heart rate.
15876424|NCT03832192|Behavioral|care.coach Avatar (HELP-Protocolized)|care.coach human-in-the-loop avatar system with software-directed protocols based on the Hospital Elder Life Program (HELP).
15876425|NCT03832179|Drug|Bevacizumab|Bevacizumab
15876426|NCT03832179|Drug|Ranibizumab|Ranibizumab
15876427|NCT03832179|Drug|Aflibercept|Aflibercept
15876428|NCT03832179|Drug|Ozurdex|Ozurdex
15876429|NCT03832166|Other|Fruits and Vegetables|Fruits and vegetables delivery, once/week for 24 weeks
15876430|NCT03832166|Other|Cooking|Nutrition education and cooking instruction class, one class/week for 6 weeks
15876431|NCT03832153|Procedure|thrombus aspiration|Thrombus aspiration will be performed by experienced interventional cardiologists according to standard practices, as previously described. The intracoronary blood samples will be collected as well during the same procedure and- along with peripheral blood samples- they will be analyzed for the presence of specific miRNAs. The aspirated thrombi will be preserved in 10% formalin solution and will be analyzed using the micro/nano-CT scanners.
15876432|NCT03832127|Drug|18F-Fludarabine|Two PET with 18F-Fludarabine : one at Baseline, the second one at the end of treatment of myeloma
15876433|NCT03832114|Drug|LNP023|Increasing doses of LNP023 up to 200 mg.
15876434|NCT03832101|Behavioral|MATB|MATB has two multitasking tasks and two attention tasks. The two multitasking tasks evaluates performance on multiple cognitively demanding assignments in both the auditory and visual domains. The two attention tasks measures performance in sustained and selective attention
15876435|NCT03832088|Diagnostic Test|Berg Balance Scale|Berg Balance Scale performed for balance disorder
15876436|NCT03832088|Diagnostic Test|Timed Up and Go Test|Timed Up and Go Test for walking speed
15876437|NCT03832088|Diagnostic Test|Jamar hand dynamometer|Jamar hand dynamometer for grip strength which correlates with muscle strength of patient
15876438|NCT03832088|Diagnostic Test|Calf circumference|Calf circumference for muscle mass evaluation. Calf circumference is an anthropometric measurement which correlates with muscle mass.
15876439|NCT03832075|Diagnostic Test|Berg Balance Scale|Berg Balance Scale is 14 item scale for detecting balance disorder.
15876440|NCT03832075|Diagnostic Test|Timed Up and Go Test|Timed Up and Go Test assesses mobility, balance, walking ability, and fall risk in older adults.
15876441|NCT03832075|Diagnostic Test|Korebalance Balance System|"Korebalance Balance System evaluates the balance and stability using objective neuro-sensory balance assessment. Static Test requires standing steady & balancing on the platform, keeping the crosshairs of cursor in the center of the test pattern. The Score indicates the deviation of user's center of gravity from the center of the pattern. Dynamic Test offers a moving cursor that the user follows. Four patterns are offered: Circle, Square, Infinity and Random. Each pattern is available in three dimensions: Small, Medium and Large; five speeds; Clockwise and Counterclockwise directions."
15876442|NCT03832062|Other|Leftover surgical tissue homogenization|Leftover surgical tissue homogenization
15876443|NCT03832049|Biological|9-valent human papillomavirus vaccine (Gardasil 9) - 3 doses|0.5mL intramuscular dose - 3 doses (0, 2 and 6 months)
15876444|NCT03832049|Biological|9-valent human papillomavirus vaccine (Gardasil 9) - 2 doses|0.5mL intramuscular dose - 2 doses (0 and 6 months)
15876445|NCT03832049|Biological|9-valent human papillomavirus vaccine (Gardasil 9) - 1 dose|0.5mL intramuscular dose - 1 doses (0 months)
15876446|NCT03832036|Diagnostic Test|Paraspinal Mapping and Quantitative Sensory Pain Test|Participants will be tested at baseline.
15876476|NCT03831802|Device|Embrace with Mate app only|Patients will wear the device on their wrist as often as possible during the day and night. This group will just use the Mate app that summarizes Embrace Watch data for the owner and captures contextual information around events.This group will not receive any alert notification on the mobile phone when a seizure takes place.
15876447|NCT03832023|Other|Screening and initiating preventive therapy in communities|Symptom-based screening of tuberculosis household child contacts by community health workers; initiation of preventive therapy (3 months of a fixed-dose combination of rifampicin-isoniazid or 6 months isoniazid for HIV+ children on protease inhibitors) in the household by a nurse; follow-up of children under preventive therapy by a community health worker for eligible children at community level, and referral of presumptive tuberculosis cases (children and adults) to the facility.
15876448|NCT03832010|Drug|Crisaborole|Participants will be instructed to apply crisaborole to affected areas with eczema.
15876449|NCT03832010|Drug|Hydrocortisone Ointment|Participants will be instructed to apply hydrocortisone to affected areas with eczema on face, armpits or groin.
15876450|NCT03832010|Drug|Triamcinolone ointment|Participants will be instructed to apply triamcinolone to affected areas on the body excluding face, armpits or groin.
15876451|NCT03832010|Drug|Aquaphor|Participants will be instructed to moisturize all over the body with Aquaphor.
15876452|NCT03831997|Drug|Dextrose 5% W/ Sodium Chloride 0.225%|D5 1/4NS is comprised of 5% dextrose in a 0.225% sodium chloride (NaCl) solution. D5 1/4NS is initially slightly hypertonic to plasma, with an osmolarity of 321 mOSm/L. As the glucose component is rapidly metabolized, 0.225% NaCl solution remains and is hypotonic to plasma at an osmolarity of 77 mOsm/L. Because of the hypotonicity of the 1/4NS, it shifts into the intracellular compartments, followed by free water, and allows for volume expansion.
15876453|NCT03831984|Drug|0,09% Bromfenac|topical 0,09% Bromfenac, one drop twice daily 3 days before surgery
15876454|NCT03831984|Drug|0,1% sodium hyaluronate|topical 0,1% sodium hyaluronate, one drop twice daily 3 days before surgery
15876455|NCT03831971|Drug|ANS-6637|Subjects will receive (1) midazolam 5 mg po single dose on Day 1 followed by (2) Drug free period on Day 2 followed by (3) ANS-6637 600 mg po daily (Days 3-7) to reach steady state followed by (4) ANS-6637 600 mg po single dose + midazolam 5mg po single dose on Day 8
15876456|NCT03831945|Biological|VRC-HIVMAB060-00-AB (VRC01)|VRC01 is a broadly neutralizing human mAb targeted against the HIV-1CD4 binding site. As single intravenous infusion of VRC01(40 mg/kg) plus10-1074 (30mg/kg) or placebo will be administered after the first analytical treatment interruption phase once the subject's plasma viremia is > or = 200 copies/mL.
15876457|NCT03831945|Biological|10-1074|10-1074 is a recombinant, fully human mAb of the IgG1 lambda isotype that specifically binds to the base of the V3 loop within HIV-1 envelope gp-120. A single intravenous infusion of VRC01 (40 mg/kg) plus 10-1074 (30 mg/kg) or placebo will be administered after the first analytical treatment interruption phase once the subject's plasma viremia is > or = 200 copies/mL.
15876458|NCT03831945|Biological|Normal Saline Placebo|2 sequential infusions of normal saline placebo in matching volumes to antibody infusions will be administered after the first analytical treatment interruption phase once the subject's plasma viremia is > or = 200 copies/mL.
15876459|NCT03831932|Drug|Osimertinib|Given PO
15876460|NCT03831932|Drug|Telaglenastat Hydrochloride|Given PO
15876461|NCT03831919|Device|SYNC III|Hoya SYNC III design spectacle lenses
15876462|NCT03831919|Device|single vision lenses|single vision spectacle lenses with no addition
15876463|NCT03831906|Diagnostic Test|Xpert MTB/RIF Ultra (Ultra)|"The intervention will consist of the WHO standard of care for children with severe pneumonia plus the study intervention consisting in rapid detection of TB on the day of hospital admission using the Ultra assay performed on 1 NPA and 1 stool sample.
~The sample flow will be organised to reduce time-to-results to 3 hours. Ultra will be performed at the hospital laboratory using a standard GeneXpert device, or implemented directly inward using a one-module, battery-operated GeneXpert device (G1 Edge).
~Drugs will be available at the inpatient level to enable immediate initiation of TB treatment, as soon as a positive Ultra result is available."
15876464|NCT03831893|Other|Nopal food product 1|Dried Nopal incorporated in a food product
15876465|NCT03831893|Other|Nopal food product 2|Dried Nopal incorporated in a food product
15876466|NCT03831893|Other|control|Food Product without nopal
15876467|NCT03831880|Drug|Genotropin|Genotropin (dose [mg] at time of enrollment) given subcutaneously once daily
15876468|NCT03831880|Drug|somatrogon|0.66 mg/kg/week given subcutaneously once weekly
15876469|NCT03831867|Other|Pilates|The intervention program consisted in the realization of exercises of the Pilates Method. The duration of the program was 32 weeks, with a frequency of two weekly sessions and a duration per intervention of 10 minutes. During this time the experimental group developed the intervention program with the Pilates Method.
15876470|NCT03831854|Drug|Lamotrigine 300 MG|300 mg of oral Lamotrigine. One of the key studies in this area was reported at the Society of Neuroscience meeting in 1997 and later published in the Archives of General Psychiatry. This study reported that, in healthy subjects 300 mg oral lamotrigine significantly decreased ketamine-induced perceptual abnormalities as assessed by the Clinician-Administered Dissociative States Scale (P<.001).31 Furthermore lamotrigine increased the immediate mood-elevating effects of ketamine (P<.05).
15876471|NCT03831854|Drug|Placebo|300 mg of oral Placebo
15876472|NCT03831854|Drug|Ketamine|1mg/kg bolus at induction followed by 5 microgram/kg/min infusion till the end of the surgery
15876473|NCT03831841|Behavioral|Multicomponent exercise programe|An intervention consisting of training by a multicomponent program 3 times a week, working on aerobic capacity, flexibility, balance and strength.
15876474|NCT03831815|Drug|Cisatracurium|Patients were allocated to two groups based on the neuromuscular blocker used by the anesthesiologist participating in the surgery. In group C, the patients in whom cisatracurium was given and the R group consisted of the patients in whom rocuronium was administered. It is emphasized that the choice of the neuromuscular blocker was made by the preference and experience of the anesthesiologist of the case and not by randomization or lottery of the patients.
15876475|NCT03831802|Device|Embrace with Alert and Mate apps|Patients will wear the device on their wrist as often as possible during the day and night. The Embrace Watch contains sensors and memory recordings of electrodermal activity, temperature and physical activity from the wearer. This group will receive notifications on the mobile phone when seizure takes place. Quality of life questionnaires will be filled by the patients at the first follow-up and final assessments.
15876477|NCT03831789|Device|Cerebellar targeted rTMS|10 Hz cerebellar rTMS (250 pulses)
15876592|NCT03830866|Radiation|external beam radiation therapy (EBRT) + brachytherapy|Radiation therapy per standard of care
15888865|NCT03736616|Drug|Carmustine|Chemotherapy
15876478|NCT03831776|Drug|Bosutinib|Bosutinib, provided by Pfizer, starting dose of 200mg QD and stepwise dose escalation (> 300 mg/d > 400 mg/d) during the first three months. A pharmacological study will be performed in the French cohort (BOSUSTEP Substudy). BOS residual plasma concentration (Cmin) will be checked after initiation, before each dose step in the French cohort, and at M3 also for Nordic patients in ancillary studies.
15876479|NCT03831776|Drug|Ropeginterferon|Ro-Peg-Interferon α2b will be supplied by AOP Orphan to be administered by subcutaneous injections from prefilled injection pens. RoPegIFN will be given in an open-label fashion. Patients assigned to RoPegIFN will start with 50 μg injected subcutaneously every 14 days, in combination with Bosutinib.
15876480|NCT03831763|Device|ColdZyme|"ColdZyme® Mouth Spray is a CE-marked medical device with the following composition: glycerol, water, cod trypsin, ethanol (<1 %), calcium chloride, trometamol and menthol.
~ColdZyme® Mouth Spray consists of a 20 ml bottle, pump, spray nozzle and protective cap."
15876481|NCT03831750|Other|Stress Reduction Intervention|The tri-component intervention is comprised of guided videos for breath-work (5-15 min), stretching (5-15 min), and meditation (10-30 min). The intervention will be delivered online via an access restricted website.
15876482|NCT03831737|Behavioral|stretching exercises|"Head/neck stretches
~Head tilt side to side
~Cross-chest stretch Torso stretches
~Side stretch
~Mid-back stretch Lower limb
~Standing quadriceps stretch
~Standing hamstring stretch"
15876483|NCT03831724|Device|EndoFLIP™ System with FLIP Topography Module|The EndoFLIP system with the EF-322N catheter will be used. The EndoFLIP system is a tool that assesses esophageal, esophago-gastric junction (EGJ)/lower esophageal sphincter (LES), and pylorus function. It allows the measurement of LES and pylorus distensibility as well as esophageal contractile activity in response to distension. The system uses impedance planimetry to measure luminal cross-sectional area (CSA) along an axial plane during volume-controlled distention.
15876484|NCT03831711|Drug|Gallium Ga 68-labeled GRPR Antagonist BAY86-7548|Given IV
15876485|NCT03831711|Procedure|Magnetic Resonance Imaging|Undergo PET/MRI
15876486|NCT03831711|Procedure|Positron Emission Tomography|Undergo PET/MRI
15876487|NCT03831711|Device|Investigational software and coils in PET/MR scan|General Electric (GE) Healthcare non-approved PET scanner coils and software
15876488|NCT03831698|Drug|Omega-3 fatty acid ethyl esters (2 gram)|Omega-3 fatty acid ethyl esters (2 gram)
15876489|NCT03831685|Other|Blood sample|Patients meeting the inclusion criteria and none of the non-inclusion criteria will benefit from 2 venous blood samples in order to precise the initial blood lactate level, e.g. at the first medical contact, and the final blood lactate level, e.g. at the hospital admission.
15876490|NCT03831659|Other|self-questionnaires|After collecting their non-opposition, a self-questionnaire will be given to them. This questionnaire is validated in the literature concerning the diagnosis of migraine. It includes questions about medical history and possible headaches
15876491|NCT03831633|Drug|Akynzeo|"1 single oral dose of NEPA (capsule) on Day 1 to be administered approximately 1 hour prior chemotherapy (containing 300 mg netupitant and 0.5 mg palonosetron).
~- Dexamethasone 12 mg on Day 1 and 8 mg daily from Day 2 to Day 4"
15876492|NCT03831633|Drug|Standard of Care|"oral aprepitant 125mg (Day 1) and 80mg daily (on Day 2 and Day 3)
~IV ondansetron 8 mg on Day 1
~Dexamethasone 12 mg on Day 1 and 8 mg daily from Day 2 to Day 4"
15876493|NCT03831607|Drug|KHK7791|KHK7791 30 mg, 20 mg ,10 mg or 5 mg tablets
15876494|NCT03831594|Device|Galvanic Vestibular Stimulation|Electrical current (under 1.5mA) applied to the mastoid processes to stimulate the balance organs in the inner ear
15876495|NCT03831594|Other|Standard Physiotherapy|45 minutes of standard physiotherapy treating impairments and functional problems
15876496|NCT03831581|Procedure|Erector Spinae Plane Block|In patients with chest pain, ultrasound-guided Erector Spinae Plane Block block was performed at T5 transverse process in the cephalo-caudal direction with Tuohy 18 gauge needle in plane until the needle tip was located in the interfascial plane between the transverse process and the erector spinae muscles, 20 ml of bupivacaine 0.5% was administered and a catheter was inserted if indicated.
15876497|NCT03831555|Behavioral|PREP-C|"The Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment (PREP-C) tool assesses a patient's psychosocial readiness to start HCV treatment. There are nine sections in the survey:
~Motivation: reasons client wants to begin HCV treatment, concerns about treatment, and the importance of treatment
~Information: knowledge about HCV treatment and one's own HCV disease status
~Medication Adherence: current prescribed medications and adherence to them in the prior month
~Self-efficacy: self-confidence about adhering to HCV treatment
~Social Support and Stability: stability of financial, housing, and social support resources
~Alcohol and substance use: alcohol and substance use behaviors and current treatment
~Psychiatric Stability: current psychiatric status, previous and current treatment
~Energy Level: sleep and fatigue
~Cognitive Functioning: perceived difficulty with communication in health care setting, problem-solving ability, and memory."
15876498|NCT03831542|Behavioral|direct follicular aspiration|direct follicular aspiration
15876499|NCT03831542|Behavioral|follicular flushing|follicular flushing
15876500|NCT03831516|Diagnostic Test|Non Invasive Electroanatomical Mapping|All patients will undergo non contrast CT chest and be fitted with the Medtronic CardioInsight wearable 252 electrode vest. Non invasive electroanatomical maps of the ventricular arrhythmia will be created. All patients will be then brought to the electrophysiology laboratory and undergo an invasive electrophysiology study and ablation of the ventricular arrhythmia.
15876504|NCT03831490|Diagnostic Test|history|combining these 4 interventions will great an algorithm predicting preeclampsia
15876505|NCT03831477|Device|Venus Viva|The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator.
15876588|NCT03830879|Other|No intervention|This cohort study have any no intervention.
15876589|NCT03830866|Biological|Durvalumab|IV infusion every 4 weeks
15876590|NCT03830866|Drug|Cisplatin|Platinum based Standard of Care Chemotherapy administered concurrent with radiation therapy
15876506|NCT03831464|Drug|Metformin Hydrochloride|"The intervention will consist in IMP treatment during 30 months with half of the patients treated with Metformin Glucophage SR. Tablets of 500mg will be used at a dose of 2x500mg preferably taken during the evening meal.
~During the first month of the trial a dose of 1x500mg will be used in order to avoid as much as possible some well-known mainly gastrointestinal side effects of metformin treatment ."
15876507|NCT03831464|Drug|Placebo Oral Tablet|The intervention will consist in IMP treatment during 30 months with half of the patients treated with matched placebo. Tablets of 500mg will be used at a dose of 2x500mg preferably taken during the evening meal.
15876508|NCT03831451|Behavioral|Stroke preparedness intervention|Face-to-face interaction with research staff lasting between 5-10 minutes
15876509|NCT03831451|Behavioral|Healthy lifestyle stroke risk reduction intervention|Face-to-face interaction with research staff lasting between 5-10 minutes
15876510|NCT03831438|Drug|AVID200|Intravenous infusion of AVID200 Q2 weeks for 3 doses
15876511|NCT03831425|Dietary Supplement|Coenzyme Q10|6 week trial of either treatment with CoenzymeQ.
15876512|NCT03831425|Other|Placebo|6 week trial of either treatment with Placebo
15876513|NCT03831412|Behavioral|CBT-I|Targeting insomnia symptoms to reduce suicidal ideation and sleep problems related to traumatic experience.
15876514|NCT03831412|Behavioral|ERRT|Targeting post-trauma nightmares to reduce suicidal ideation and sleep problems related to traumatic experience.
15876515|NCT03831399|Dietary Supplement|Leucine|Administration 6 g/day of leucine at noon (12 pm) and in the late afternoon (8 pm) for 13 weeks
15876516|NCT03831399|Dietary Supplement|Placebo|Administration 6 g/day of lactose at noon (12 pm) and in the late afternoon (8 pm) for 13 weeks
15876517|NCT03831386|Procedure|Vacuum-Based IPC|An indwelling pleural catheter is placed inside the chest cavity to drain fluid from around the lungs. One end remains inside the body while the other drains via suction.
15876518|NCT03831386|Procedure|Gravity-Based IPC|An indwelling pleural catheter is placed inside the chest cavity to drain fluid from around the lungs. One end remains inside the body while the other drains via gravity.
15876519|NCT03831373|Other|Physical exercise|Three physical exercise programs, two of resistance training with elastic bands and one of stretching exercises, all performed in a sitting position.
15876522|NCT03831347|Behavioral|Hatha Yoga|12 weeks of Hatha Yoga
15876523|NCT03831334|Drug|oral minoxidil|Participants will be provided with minoxidil (2.5 mg tablets) for 90 days (45 tablets + 5 extra in case of splitting difficulty) of treatment drug in dispensing containers and instructed to take half a pill (1.25mg), once a day.
15876524|NCT03831321|Drug|Diclofenac Sodium|50 mg of diclofenac sodium will be administered to intervention group one hour before cystoscopy and lubricant gel with lidocaine will be administered to all patients just before cystoscopy.
15876525|NCT03831321|Device|Cystoscopy|Diagnostic cystoscopy
15876526|NCT03831321|Drug|Lubricant Gel|To prevent patients from side effects of cystoscopy ( like urethral strictures and discomfort)
15876527|NCT03831308|Diagnostic Test|clinical and physical assessment|information will be collected on fitness status, lifestyle, cognitive and psychological status, bone's health and quality of life
15876528|NCT03831295|Biological|Anti-OX40 Antibody BMS 986178|Given IT or IV
15876529|NCT03831295|Drug|TLR9 Agonist SD-101|Given IT
15876530|NCT03831282|Device|RD SET Neo SpO2|All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor.
15876531|NCT03831269|Drug|Azithromycin|Patients will be randomly distributed and start taking azithromycin according to the known dose /kg/day for repeated cycles till improvement or reaching the end of study
15876532|NCT03831269|Other|nbUVB|The patients will be randomly distributed to start nbUVB sessions and clinical improvement will be compared to that of Azithromycin
15876533|NCT03831256|Diagnostic Test|Traditional integrated prenatal screening|biochemical prenatal screening with or without nuchal translucency by US
15876534|NCT03831256|Diagnostic Test|Second-tier Non-invasive prenatal screening (NIPS)|genomics based NIPS after a positive traditional prenatal screen
15876535|NCT03831256|Diagnostic Test|First-tier Non-invasive prenatal screening (NIPS)|genomics based NIPS at first trimester
15876536|NCT03831256|Diagnostic Test|Invasive prenatal testing for fetal aneuploidy|amniocentesis or chorionic villi sampling (CVS)
15876537|NCT03831243|Radiation|Stereotactic body radiotherapy|Treatment will be prescribed to the periphery of the target, i.e. 80% of the dose should cover 95% of the PTV. The organ at risk (OAR) dose constraints will be in accordance with the recommendations from the report of the American Association of Physicists in Medicine (AAPM) task group 101. Image-guidance will consist of cone-beam CT in combination with 6 degrees of freedom corrections using robotic couch.
15876538|NCT03831243|Radiation|3D-conformal radiotherapy|In the standard setting, 95% of the PTV should receive 95% of the prescribed dose while near maximum dose (Dnear-max) in the PTV should not exceed 107%. Image-guidance will consist of portal images showing the relevant bony anatomy.
15876539|NCT03831230|Genetic|collection of blood, urine, tumor and ascite samples|collection of blood, urine, tumor and ascite samples during ovarian surgery
15876540|NCT03831217|Procedure|mid urethral sling surgery|patients with clinically and/or urodynamically proven stress urinary incontinence underwent mid urethral sling surgery under general anesthesia.
15876541|NCT03831204|Device|biopac|"Acoustic cardiography was performed for all participants using the BIOPAC system with Student Lab software version 3.7.2. An electrocardiogram was obtained by two electrodes placed at the right upper limb and the lower left limb. Simultaneously heart sounds were recorded with a specific sensor placed at the mitral focus."
15876542|NCT03831204|Diagnostic Test|prognostic scores|Effect and GWTGHF were calculated for every patient
15876543|NCT03831191|Drug|LY3375880|Administered SC
15876544|NCT03831191|Drug|Placebo|Administered SC
15876545|NCT03831178|Dietary Supplement|Docosahexaenoic acid (DHA)|Participants will take 11 capsules of DHA oil for 12-18 weeks (84-126 days), beginning on day 1 of initial cycle of chemotherapy, and continuing for 4-6 cycles of chemotherapy prior to definitive breast surgery. Study will end when subject undergoes breast surgery.
15877377|NCT03824743|Drug|Lactate Ringer|Patients managed with Lactate Ringer and obstetric hemorrhage
15876546|NCT03831178|Drug|Placebo oral capsule|Participants will take 11 capsules of placebo (corn/soy oil blend) for 12-18 weeks (84-126 days), beginning on day 1 of initial cycle of chemotherapy, and continuing for 4-6 cycles of chemotherapy prior to definitive breast surgery. Study will end when subject undergoes breast surgery.
15876547|NCT03831165|Combination Product|Melatonin|The volunteers will receive information about the study and sign the free and informed consent form (ICF). After, will be delivered bottle identified by letters (abc, bca or cab) with its drug without patient and investigator know its nature. It will only be revealed which drug was used by every woman at the end of the study; but occurring worsening of herpetic disease, the blind will be broken for proper assessment of the participant. If the employee drug is melatonin, this case will be considered as therapeutic failure in the final statistical analysis.
15876548|NCT03831165|Drug|Acyclovir 400 MG|These individuals will be instructed to take 2 tablets of 200mg acyclovir (400 mg) twice daily for 90 days
15876549|NCT03831152|Drug|ADV7103|Single group assignment
15876550|NCT03831139|Behavioral|TIM&SARA|
15876551|NCT03831126|Drug|Betamethason Sodium Phosphate|First measurement: 12-36 hours after betamethasone treatment Second measurement: within five days after betamethasone treatment and two weeks Third measurement (neonatal measurement): 1-8 weeks after birh
15876552|NCT03831113|Drug|Buprenorphine: Magnitude Group|Dose reductions will continue until the subject is no longer taking buprenorphine or is at the lowest tolerable dose.
15876553|NCT03831113|Drug|Buprenorphine: Frequency Group|Dose reductions will continue until the subject is no longer taking buprenorphine or is at the lowest tolerable dose.
15876554|NCT03831113|Drug|Buprenorphine: Dosing Group|Dose reductions will continue until the subject is no longer taking buprenorphine or is at the lowest tolerable dose.
15876555|NCT03831100|Behavioral|BRIGHT|The BRIGHT intervention consists of 5 weekly, 60-minute, tablet-based, one-one telehealth sessions with a licensed therapist. BRIGHT Therapist: A licensed clinical psychologist with extensive experience managing pyscho-oncologic concerns in patients with HNC will deliver BRIGHT.
15876556|NCT03831100|Behavioral|Active Control|AC consists of 5 weekly sessions of videos about HNC survivorship that are delivered using a telemedicine platform. Each AC session (Table 5) is a compilation of shorter videos featuring HNC survivors, caregivers, and oncologists discussing non-body image aspects of HNC survivorship.
15876557|NCT03831087|Diagnostic Test|TAVR-CMR|CMR protocol for the exact determination of the aortic valve dimensions, valve size and implantation route.
15876558|NCT03831087|Diagnostic Test|TAVR-CT|CT protocol for the exact determination of the aortic valve dimensions, valve size and implantation route.
15876559|NCT03831074|Device|Implantation of an intraocular lenses: iMics 1 NY-60 & NY-60G|
15876560|NCT03831061|Other|Cognitive stimulation|
15876561|NCT03831048|Device|OCS Heart System|Preserving and assessing donor after circulatory death hearts for transplant
15876562|NCT03831048|Other|Cold Storage|Active comparator intervention
15876563|NCT03831035|Other|Genetic analyse by whole exome sequencing|Exome sequencing requires analytic, bio informatic and interpretation steps.
15876564|NCT03831022|Other|Capillary refill time and skin mottling score measurement at the admission to the emergency department|Patients who meet the inclusion criteria and none of the non-inclusion criteria will benefit from capillary refill time and skin mottling score measurement at the admission to the emergency department (ED) and followed during their hospital stay to precise the destination after ED (home, ICU, ward) and 30- and 90-days mortality after hospital admission.
15876565|NCT03831009|Procedure|Open reduction internal fixation (ORIF)|Open fracture reduction followed by internal fixation using a plate and screws. The goal is an osteosynthesis that allow for early range-of-motion exercises, but weightbearing is usually not tolerated until 6 weeks postoperatively.
15876566|NCT03831009|Other|Conservative treatment|Conservative treatment involves ankle protection with a functional brace (AirCast) for 6 weeks. Participants will be instructed to bear weight as tolerated and to actively do standardized range-of-motion exercises.
15876567|NCT03830970|Dietary Supplement|Canned beans of multiple varieties|Daily rotation of different varieties of canned beans including black, navy, pinto, red kidney and white kidney
15876568|NCT03830970|Dietary Supplement|White Rice|Minute Rice Long Grain White Rice
15876569|NCT03830957|Drug|Ivabradine|7.5 mg oral single dose if the heart rate would not reach to 60/minute then give another dose, 7.5 mg
15876570|NCT03830957|Drug|Metoprolol|5 mg oral single dose if the heart rate would not reach to 60/minute then give another dose, 5 mg
15876571|NCT03830944|Diagnostic Test|Blood sampling|Assessment of complete blood count, biochemistry, inflammatory biomarkers, adhesion molecules
15876572|NCT03830944|Diagnostic Test|transthoracic echocardiography|Assessment of the ventricular anatomy, size, function, speckle tracking, myocardial strain, valvular function.
15876573|NCT03830944|Diagnostic Test|Late Gadolinium-Enhancement Cardiac Magnetic Resonance|Assessment of the ventricular anatomy, function, viability, degree of fibrosis, quantification of infarct size, mass.
15876574|NCT03830944|Diagnostic Test|Coronary Angio Computed Tomography|Assessment of coronary plaque anatomy, morphology, vulnerability features, quantification of epicardial adipose tissue
15876575|NCT03830918|Biological|Atezolizumab|Given IV
15876576|NCT03830918|Drug|Niraparib|Given PO
15876577|NCT03830918|Other|Quality-of-Life Assessment|Ancillary studies
15876578|NCT03830918|Other|Questionnaire Administration|Ancillary studies
15876579|NCT03830918|Drug|Temozolomide|Given PO
15876580|NCT03830905|Drug|XC221|Participants will receive 200 mg XC221 once a day during 3 days
15876581|NCT03830905|Drug|Placebo|Participants will receive Placebo once a day during 3 days
15876582|NCT03830892|Other|E-cigarette Lab Session 15 watts, 10 mg nicotine|E-cigarette paired with low nicotine, low device power
15876583|NCT03830892|Other|E-cigarette Lab Session 15 watts, 30 mg nicotine|E-cigarette paired with low nicotine, low device power
15876584|NCT03830892|Other|E-cigarette Lab Session 30 watts, 10 mg nicotine|E-cigarette paired with low nicotine, low device power
15876585|NCT03830892|Other|E-cigarette Lab Session 30 watts, 30 mg nicotine|E-cigarette paired with low nicotine, low device power
15876586|NCT03830892|Other|Own Brand Session - E-cigarette|E-cigarette paired with own brand liquid and preferred power
15876587|NCT03830892|Other|Own Brand Session - E-cigarette/Cigarette|Own brand cigarette OR E-cigarette paired with own brand liquid and preferred power
15876594|NCT03830814|Procedure|Echocardiography|Basal two dimensional and three dimensional echocardiographic parameters were compared to those obtained 3 months after starting the sacubitril/valsartan treatment
15876595|NCT03830801|Device|IVLCM tethered capsule|Obtaining biopsies for genomic sequencing of BE for the assessment of EAC risk using IVLCM tethered capsule
15876596|NCT03830788|Radiation|Radiation by brachytherapy|Brachytherapy by Iodine 125 delivering 144 Gy to the prostate
15876597|NCT03830788|Radiation|Radiation by SBRT|SBRT delivers 7.25 Gy per fraction, in five fractions, corresponding to a total dose of 36.25 Gy to the prostate. Fiducials are implanted in the prostate.
15876598|NCT03830775|Procedure|Platelet-rich plasma (PRP)|"PRP is obtained from obtaining an autologous blood sample, which is then condensed in a small commercial centrifuge to isolate a concentrated sample of platelets and growth factors. This sample contains high concentrations of Platelet-derived growth factors (PDGF), transforming growth factors β (TGFβ), insulin-like growth factor-1 (IGF1), and vascular endothelial growth factor-1 (VEGF) all of which aid in healing of soft tissues. (Padilla) The blood sample is autologous, the concentration is prepared in the clinic, and the complications of the injection are no greater than any other injection given in the clinic.
~All patients will have a blood sample prepared for PRP. The patient will then be blinded and half will randomly be assigned to PRP injection (2cc) and half will be randomly assigned to placebo (2cc of 0.9% sterile saline)"
15876599|NCT03830762|Drug|Xanamem|Oral Xanamem capsules 20mg or 30mg, administered PO once daily. Xanamem is formulated in green and cream coloured size 3, Coni-Snap shaped gelatin capsules as an excipient blend at a dose of 10mg. It contains active pharmaceutical ingredient of UE2343.
15876600|NCT03830762|Drug|Matching Placebo|Matching placebo which is identical in appearance to the test product (20mg, 30mg Xanamem™ QD) except that it contains no active ingredient.
15876601|NCT03830749|Drug|Eltrombopag|Eltrombopag Oral Tablet 25-75 mg daily for 12 weeks plus pulsed dexamethasone
15876602|NCT03830736|Combination Product|Oat Beverage 1|Oat based beverage with added different concentration of extracted oat component.
15876603|NCT03830736|Combination Product|Oat Beverage 2|Oat based beverage with added different concentration of extracted oat component.
15876604|NCT03830736|Combination Product|Oat Beverage 3|Oat based beverage with added different concentration of extracted oat component.
15876605|NCT03830736|Combination Product|Oat Beverage 4|Oat based beverage with added different concentration of extracted oat component.
15876606|NCT03830736|Combination Product|Control product|Glucose based beverage without added test components is used as control product
15876607|NCT03830723|Drug|Follitropin delta|Study medication doses during all 3 insemination will be personalized using a suggested algorithm
15876608|NCT03830697|Other|Acupuncture intervention|Patients in the experimental group were given acupuncture treatment for 12 weeks prior to COH. If the patient has a good COH timing during acupuncture treatment, he or she will enter the COH cycle at any time.The acupuncture intervention program of the test group is as follows:Acupoint group 1: Baihui（DU20）, Zhongyu（RN12）, Tianshu （ST25）(bilateral), Guanyuan（RN4）, uterus (bilateral)（EX-CA1）, Dahe（KI12） (bilateral),Zusanli （ST36）(bilateral), Sanyinjiao（SP6） (bilateral), Taichong （LR3）(both sides).
15876609|NCT03830684|Drug|Baicalein Tablets 400mg|4 Baicalein Tablets and 2 placebo per time, three times a day
15876610|NCT03830684|Drug|Baicalein Tablets 600mg|6 Baicalein Tablets per time, three times a day
15876611|NCT03830684|Drug|blank control 0mg|6 placebo per time, three times a day
15876612|NCT03830671|Drug|18-month regimen containing 6 anti-TB drugs|Investigational regimen:3Am-Mfx-PZA-X-Y-Z/3Am3-Mfx-PZA-X-Y-Z/12 Mfx-PZA-X-Y-Z.X、Y、Z are the drugs susceptible or possibly susceptible to mycobacterial bacilli(The candidated drugs to be selected are:Cs-Cycloserine,Pto-Protionamide,Clr-Clarithromycin,PAS-sodium para-aminosalicylate,E-ethambutol,Bdq-Bedaquiline,Cfz-Clofazimine,Lzd-linezolid).The abbreviation of the name of each drug in the regimen is explained as follows: PZA-pyrazinamide，Am-Amikacin，Mfx-moxifloxacin）and the total duration of the regimen is 18 months
15876613|NCT03830658|Behavioral|Structured Intervention on Self-care with AVF (SISC-AVF)|"Theoretical Part: structured intervention involved an educational group session with the purpose of teaching patients how to identify situations that can compromise AVF working. Each presentation allowed a maximum of eight patients and took 30 minutes. Each presentation was assessed in the end by asking participants to identify the signs and symptoms of infection, thrombosis and steal syndrome and to describe the care to be taken during dialysis and in the period outside dialysis.
~Practical Part: started a week after the theoretical part, lasting for two weeks, and was given to each participant in an appropriate room at the beginning of the HD treatment. Interactive training sessions were conducted using an informal approach with the objective of developing skills of inspection and palpation of the AVF arm. Inspection had the purpose of enabling participants to identify situations that could compromise the working of the AVF. Each patient was given two 15-minute sessions."
15876614|NCT03830645|Biological|Platelet Rich Plasma|Application of platelet rich plasma through the intercostal tube into the pleural space
15876615|NCT03830632|Other|Plyometric Training|
15876616|NCT03830632|Other|Traditional Training|
15876617|NCT03830619|Diagnostic Test|collect samples|collect serum samples and clinical features
15876618|NCT03830606|Drug|Nab-paclitaxel,S-1|Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) and S-1 (40mg BID for body surface area < 1.25 m2; 50mg BID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area >1.5 m2; D1-14, q3w)
15876619|NCT03830593|Procedure|Laparoscopic Adrenalectomy|minimally invasive lateral transperitoneal adrenalectomy
15876620|NCT03830580|Other|Positive stimulation (singing)|A nurse or assistant trained in singing with an operal singer sings a lullaby She sits next to the incubator and sings from the time the sucrose is administered (2 minutes before the fundus exams is performed) until the end of the examination - taking into account the child's reaction
15876621|NCT03830567|Other|Pharmacist prescription|Pharmacist prescribed hormonal contraception (initiation or continuation).
15876622|NCT03830567|Other|Clinician prescription|Clinician prescribed hormonal contraception (initiation or continuation).
15876662|NCT03830307|Device|NSS-2-Bridge|NSS-2-Bridge auricular therapy will be given in addition to standard of care
15876663|NCT03830294|Other|different temperature-controlled breast prostheses|Two types of temperature-controlled breast prostheses were applied to patients in each group
15876664|NCT03830281|Drug|Ultra-Rapid Lispro|Administered SC
15876623|NCT03830554|Other|Organic Atlas cedar wood essential oil (Cedrus Atantica)|At first day of admission, Intervention group received an intervention kit consist of 5 small glass essential oil bottles. Each essential oil bottle contains a small cotton ball saturated with two drops of Organic Atlas cedar wood essential oil (Cedrus Atantica). Participants were asked to open the bottle, inhale the smell directly and put it opened at 20 cm beside bed during night.
15876624|NCT03830541|Other|Oral care delivery analysis in participants with ASD|The analysis of oral health status, tooth loss, oral rehabilitation, characteristics of routine dental treatment and treatment in general anaesthesia in persons with ASD
15876625|NCT03830528|Drug|KW-6356 Low Dose|KW-6356 will be administered as single doses.
15876626|NCT03830528|Drug|KW-6356 Middle Dose|KW-6356 will be administered as single doses.
15876627|NCT03830528|Drug|KW-6356 High Dose|KW-6356 will be administered as single doses.
15876628|NCT03830528|Drug|KW-6356 X Dose|KW-6356 will be administered as multiple doses.
15876629|NCT03830528|Drug|KW-6356 Y Dose|KW-6356 will be administered for Japanese healthy men as multiple doses.
15876630|NCT03830528|Drug|Placebo|All study cohorts (except Part C) are placebo controlled.
15876631|NCT03830515|Device|microMend|Wound closure product consisting of tan array of tiny metal Microstaples affixed to adhesive backing. The device is the size and shape of a butterfly closure and intended for closure of skin wounds.
15876632|NCT03830502|Procedure|Surgical sterilization|Surgical sterilization either standard salpingectomy or tubal ligation with Pomeroy technique
15876633|NCT03830489|Drug|polyethylene glycol|The experimental arm will take 4 L polyethylene glycol solution (PEG) in split dose plus bisacodyl and 3 days of fiber-free diet
15876634|NCT03830489|Drug|polyethylene glycol plus ascorbic acid|The control arm will take 2 L polyethylene glycol solution (PEG) plus ascorbic acid in split dose plus 1 day of fiber-free diet
15876635|NCT03830476|Behavioral|Acceptance- and Commitment therapy group for parents to children with disabilities|ACT groups adjusted for parents to children with (any kind of) disabilities.
15876636|NCT03830476|Behavioral|Treatment as usual.|Treatment as usual within outpatient disability services.
15876637|NCT03830463|Drug|CTP-692|Single oral dose
15876638|NCT03830463|Drug|Placebo|Single oral dose
15876639|NCT03830437|Other|Evaluation of newborn stress|Newborn stress will be evaluated by salivary cortisol levels at 48 hr of life. Saliva sample of the newborns will be collected in oral cavity at 48 hr of life. Samples collected will be storage at -80 C for up to 4 months and analysed by analysis laboratory of Poliambulanza Foundation.
15876640|NCT03830437|Other|Evaluation of body weight trend|Body weight trend between newborns subjected to double weighing or to body weight control will be carried out at 36 hr and 48 hr of life
15876641|NCT03830424|Procedure|Pain stimulus|Pain stimulus - intramuscular K vitamin administration, heel lancing = standard healthcare procedure
15876642|NCT03830424|Dietary Supplement|Non-pharmacological pain relief|Administration of sucrose/mother milk during pain stimulus
15876643|NCT03830411|Drug|Sintilimab|Sintilimab will be administered intravenously at a fixed dose of 200 milligrams (mg) on Day 1 of each 21-day cycle.
15876644|NCT03830411|Drug|Docetaxel|Docetaxel 75 milligrams per square meter (mg/m^2) will be administered intravenously on Day 1 of each 21-day cycle.
15876645|NCT03830411|Drug|Pemetrexed|Pemetrexed 500 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle.
15876646|NCT03830398|Drug|Paracetamol|The investigators apply paracetamol during a week in preoperative room 45 min before ECT
15876647|NCT03830398|Drug|Deksketoprofen trometamol|The investigators apply paracetamol during a week in preoperative room 45 min before ECT
15876648|NCT03830398|Drug|Placebo|The investigators apply placebo during a week in preoperative room 45 min before ECT
15876649|NCT03830385|Drug|PaclitaxelPaclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or Carboplatin|All patients enrolled in the study will accept Paclitaxel (Albumin Bound),Bleomycin combined with Cisplatin or Carboplatin as their firstline chemotherapy
15876650|NCT03830372|Device|VR Tier One|"10 sessions of 20 minutes virtual terapeutic game
~Thanks to using VR googles and the phenomenon of total immersion VR Tier One terapy game allows to completely separate the patient from the hospital environment and provides an intense visual, auditory and kinesthetic stimulation. Depending on the stage of therapy it can have a calming and mood-improving effect or it can motivate and cognitively activate the patient. The additional aim of the game is to help the patients regain their emotional balance, let them recognize their resources in order to bring them to power in the rehabilitation process and trigger the natural recovery mechanisms."
15876651|NCT03830372|Other|Control|10 sessions of 20 minutes of Schultz Autogenic Training
15876652|NCT03830359|Other|T2769|55 patients treated by T2769 for 42 days
15876653|NCT03830346|Other|Instrument-assisted|instrument-assisted soft tissue mobilization techniques (applied with the subject in prone position. The technique lasted 20 seconds in a parallel direction and 20 seconds in a perpendicular direction on the posterior shoulder and scapula muscles. While the dominant hand was used to hold the instrument, the other hand was used to tighten the skin medially to ensure an even area of treatment) and post-isometric horizontal adduction stretches (carried out with the subject in the supine position, passively adducting the arm horizontally until the first motion barrier and performing active horizontal abduction for 5 seconds at 25% of force. The arm was then taken to the new motion barrier, repeating this process three times).
15876658|NCT03830320|Drug|[64Cu]FBP8|Injection of Copper-64 radiopeptide to detect thrombosis
15876659|NCT03830320|Device|PET/MR|Whole body imaging using Siemens mMR PET/MR scanner
15876660|NCT03830320|Procedure|Blood Collection|A total of 9 cc of blood sampled before, during, and after imaging for clinical chemistry
15876661|NCT03830320|Procedure|Electrocardiogram|A standard 12-lead ECG will be obtained pre-and-post injection with radiotracer
15876666|NCT03830268|Dietary Supplement|No MCT intake with breakfast, no lunch|Water given with a regular standardize breakfast and water given at noon without lunch.
15876667|NCT03830268|Dietary Supplement|No MCT intake with lunch, no breakfast|Water given in the beginning of the metabolic study day without breakfast and water given at noon with a regular standardize lunch.
15876668|NCT03830268|Dietary Supplement|10g of Betaquik|BQ10 given with a regular standardize breakfast and BQ10 given at noon without lunch.
15876669|NCT03830268|Dietary Supplement|10g of Betaquik with low-carbs breakfast|BQ10 given with a low-carbs standardize breakfast and BQ10 given at noon without lunch.
15876670|NCT03830268|Dietary Supplement|20g of Betaquik|BQ20 given with a regular standardize breakfast and BQ20 given at noon without lunch.
15876671|NCT03830268|Dietary Supplement|10g of Betaquik with lunch, no breakfast|BQ10 given in the beginning of the metabolic study day without breakfast and BQ10 given at noon with a regular standardize lunch.
15876672|NCT03830242|Diagnostic Test|<Sup>18<Sup>F-FDG PET/CT dynamic scan|The purpose of this study is to carry out <Sup>18<Sup>F-FDG PET/CT dynamic scans and Pathological examination of metastatic central lymph nodes in newly diagnosed patients with papillary thyroid cancer, and to compare imaging findings, genomics, and pathology at the same time. The intrinsic relationship between tissue characteristics and the diagnostic value of <Sup>18<Sup>F-FDG PET/CT dynamic imaging in metastatic central lymph nodes with papillary thyroid cancer are discussed.
15876673|NCT03830242|Diagnostic Test|B-ultrasonography|The purpose of this study is to carry out <Sup>18<Sup>F-FDG PET/CT dynamic scans and Pathological examination of metastatic central lymph nodes in newly diagnosed patients with papillary thyroid cancer, and to compare imaging findings of B-ultrasonography , genomics, and pathology at the same time. The intrinsic relationship between tissue characteristics and the diagnostic value of <Sup>18<Sup>F-FDG PET/CT dynamic imaging in metastatic central lymph nodes with papillary thyroid cancer are discussed.
15876674|NCT03830216|Device|Connected insulin pen and smartphone app|The InPen system is a reusable pen injector for single-patient use by people with diabetes age 12 and older for the self-injection of a desired dose of insulin. The pen injector is paired with a smartphone app with dose calculator.
15876675|NCT03830216|Device|Inactive connected insulin pen without smartphone app|The InPen system is a reusable pen injector for single-patient use by people with diabetes age 12 and older for the self-injection of a desired dose of insulin. The pen injector is inactive and not paired with a smartphone app or dose calculator.
15876676|NCT03830203|Drug|BAT1806|8 mg/kg
15876677|NCT03830203|Drug|Actemra(EU-licensed)|8 mg/kg
15876678|NCT03830190|Other|Parkinson's disease nurse specialist care|Specialized nursing care provided by a Parkinson's disease nurse specialist
15876679|NCT03830177|Drug|Natural Treatment|The participant will be given the treatment, which contains all natural ingredients, and a kit of all necessary materials to take home with them, which will include a set of instructions. The kit will contain the instruction handout and their treatment. They will be instructed to apply the treatment to their scalp, wait seven minutes, and then rinse their scalp. They will perform this entire procedure once per day for 14 days.
15876680|NCT03830164|Drug|Atorvastatin|Given PO
15876681|NCT03830164|Drug|Pentoxifylline|Given PO
15876682|NCT03830164|Dietary Supplement|Vitamin E Compound|Given PO
15876683|NCT03830151|Drug|Hyperpolarized Carbon C 13 Pyruvate|Given IV
15876684|NCT03830151|Procedure|Magnetic Resonance Spectroscopic Imaging|Undergo MRSI
15876685|NCT03830138|Genetic|Oxidized-LDL gene polymorphism|Oxidized-LDL gene polymorphism will be measured by RFLP. In addition, Oxidized-LDL will be measured in the plasma by ELISA
15876686|NCT03830125|Drug|BBT-877, Single dose|Single dose of BBT-877, 5 dose levels, oral capsule
15876687|NCT03830125|Drug|Placebo group|Placebo matched to BBT-877, oral capsule
15876688|NCT03830125|Drug|BBT-877, Multiple doses|Multiple doses of BBT-877, 14 days, 8 dose levels, oral capsule
15876689|NCT03830112|Behavioral|Pilates exercise with Theraband|The experimental group will perform all the exercises with Theraband® in the same manner than active comparator group.
15876690|NCT03830112|Behavioral|Pilates exercise|The active comparator group will perform all the exercises without Theraband®
15876691|NCT03830086|Drug|Midazolam|Used for general anesthesia for gynecological laparoscopic procedures, together with Propofol, Sufentanil, Rocuronium, Sevoflurane
15876692|NCT03830086|Drug|Sufentanil|Used for regional anesthesia (spinal or combined spinal-epidural anesthesia) for gynecological laparoscopic procedures together with Bupivacaine; and for general anesthesia for gynecological laparoscopic procedures, together with following drugs: Midazolam, Propofol, Rocuronium, Sevoflurane
15876693|NCT03830086|Drug|Propofol|Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Sufentanil, Rocuronium, Sevoflurane
15876694|NCT03830086|Drug|Rocuronium|Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Propofol, Sufentanil, Sevoflurane
15876695|NCT03830086|Drug|Sevoflurane|Used for general anesthesia for gynecological laparoscopic procedures, together with the following drugs: Midazolam, Propofol, Sufentanil, Rocuronium
15876696|NCT03830086|Drug|Bupivacaine|Used for regional anesthesia (spinal or combined spinal-epidural anesthesia) for gynecological laparoscopic procedures, together with Sufentanil
15876697|NCT03830073|Genetic|Measurement of VDR genetic polymorphism|VDR genetic polymorphism will be measured by RFLP and correlated with viral, autoimmune markers.
15876698|NCT03830060|Diagnostic Test|Measurement of cortisol|Cortisol will be measured by immunofluorescence and correlated with ANA and hs-CRP
15876699|NCT03830047|Device|nd yag laser|nd yag laser will be applied on the vulval warts
15876700|NCT03830034|Drug|Amino Acid chelated iron tab 15 mg|"Contain 75 pregnant women will recommended to take ferrotrone(iron chelated amino acid containing 15mg elemental iron) a dose recommended by the company of the product.
~Iron tablets should be taken at night or at least 1 hour prior to food to maximise absorption.
~Substances that inhibit absorption such as tannins & milk should be avoided but fruit juice contain ascorbic acid taken in conjunction with iron supplements increases their absorption.
~Follow up will be done for all the pregnant women included in our studies at baseline & then 4, 8 & 12 weeks after treatment at each visit breif history for outcomes and adverse effects will reviewed."
15876856|NCT03829007|Drug|Durvalumab|Durvalumab treatment is initiated after the PET/CT scan in a fixed dose of 1500 mg iv q4w
15876701|NCT03830034|Drug|Ferrous Fumarate tab 350 mg( 115 mg elemental iron)|"75 pregnant women will recommended to take ferrous fumarate e.g. Hema-caps (ferrous fumarate 350 mg with elemental iron 115mg) prepared by another egyptian pharmaceutical company (Amoun pharmaceutical company) once daily but in sever cases of iron deficiency anemia (Hb<9g/dl) this dose can be doubled as recommended by the company of the product.
~Some instructions will be given to all the pregnant women included in our study as follow: Iron tablets should be taken at night or at least 1 hour prior to food to maximise absorption.
~Substances that inhibit absorption such as tannins & milk should be avoided but fruit juice contain ascorbic acid taken in conjunction with iron supplements increases their absorption.
~Follow up will be done for all the pregnant women included in our studies at baseline & then 4, 8 & 12 weeks after treatment at each visit breif history for outcomes and adverse effects will reviewed."
15876702|NCT03830021|Behavioral|Salt reduction program|Dietary and behavioural change program, led by nutritionists, including low sodium dietary advice; use of aromatic herbs and spices in food instead of salt; motivational activities; food diaries; restrict salty processed foods; eat more fresh foods and seasoning advice; problem solving exercises; digital bulletins; individual counselling reinforced at each clinic visit and shopping counselling at local supermarket.
15876703|NCT03830021|Behavioral|Healthy lifestyle program|Participants receive an educational healthy lifestyle program that includes 1) methods to cook healthier and the Mediterranean diet based on a high intake of fresh fruit and, vegetables, beans, grain legumes, lentils, nuts, cereals, and olive oil as source of fat; moderate intake of fish, poultry, yoghurt and cheese, low intake of salt, red meat, processed meats and sugar; 2) physical activity; 3) drink more water and reducing alcohol consumption; and 4) sleep education.
15876704|NCT03830008|Behavioral|Problem Management Plus|PM+ is a new, brief, psychological intervention program based on CBT techniques that are empirically supported and formally recommended by the WHO. The full protocol was developed by the WHO and the University of New South Wales, Australia. The manual involves the following empirically supported elements: problem solving plus stress management, behavioural activation, facing fears, and accessing social support. These elements have been recommended in recent WHO guidelines.
15876705|NCT03829995|Other|Drug counseling|Participants can contact a hospital pharmacy department by phone or mail and ask questions regarding drug-related issues.
15876706|NCT03829982|Behavioral|Exposure to bright light during the day|Participants will be exposed to bright light (1250 lux) between 8:00 and 18:00 and to dim light (5 lux) between 18:00 and 23:00.
15876707|NCT03829982|Behavioral|Exposure to dim light during the day|Participants will be exposed to dim light (10 lux) between 8:00 and 18:00 and to dim light (1250 lux) between 18:00 and 23:00.
15876708|NCT03829969|Biological|Toripalimab|TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy or placebo combine with chemotherapy
15876709|NCT03829956|Device|Intraoral tongue stimulator (Snoozeal)|Electrical stimulation of the tongue muscle to improve muscle tone to treat primary snoring and mild obstructive sleep apnea.
15876710|NCT03829943|Diagnostic Test|Vitamin D|Blood will be drawn for Vitamin D level
15876711|NCT03829930|Drug|Entinostat|"Entinostat is formulated for oral administration. A food effect is evident for entinostat; exposure is significantly reduced when entinostat is administered with a high fat meal. Accordingly, entinostat is to be administered on an empty stomach, at least 1 hour before and 2 hours after a meal. Entinostat tablets should not be split, crushed, or chewed. Consult the individual clinical protocols for specific dosing instructions.
~Dose level 1: 3mg PO weekly. Dose level 2: 5mg PO weekly."
15876712|NCT03829930|Drug|Enzalutamide|Dose level 1: 160 mg PO daily. Dose level 2: 160 mg PO daily.
15876713|NCT03829917|Drug|Miltefosine and Paromomycin|28 days of miltefosine plus 28 days of Paromomycin cream
15876714|NCT03829917|Drug|miltefosine|28 days of miltefosine
15876715|NCT03829917|Drug|paromomycin|28 days of paromomycin creaam
15876716|NCT03829904|Drug|VGH-BPH1|A scientific Chinese granule powder
15876717|NCT03829904|Drug|Placebo (Corn starch pill manufactured to mimic VGH-BPH1)|Corn starch pill manufactured to mimic VGH-BPH1
15876718|NCT03829891|Drug|Beinaglutide|"Beinaglutide for 8 weeks,
~Beinaglutide + glargine for 8 weeks(only the subjects whose blood glucose not reach the standard )"
15876719|NCT03829891|Drug|glargine|"Glargine for 8 weeks,
~Glargine+Beinaglutide for 8 weeks(only the subjects whose blood glucose not reach the standard )"
15876720|NCT03829878|Drug|CP101|Orally administered donor derived full spectrum microbiota
15876721|NCT03829878|Drug|Placebo|Placebo for CP101
15876722|NCT03829865|Diagnostic Test|High resolution esophageal manometry|High resolution esophageal manometry will be performed to eligible subjects willing to participate in the study
15876723|NCT03829852|Drug|Regorafenib|Treatment was performed based on physician's discretion
15876724|NCT03829839|Drug|Oxytocin|Intranasal administration, 24 international units (IU) oxytocin
15876725|NCT03829839|Drug|Lorazepam 1 mg|Oral administration of 1mg lorazepam
15876726|NCT03829839|Drug|Placebo nasalspray|The placebo nasalspray contain identical ingredients except for the active agent itself.
15876727|NCT03829839|Drug|Placebo Oral Tablet|The placebo pill contain identical ingredients except for the active agent itself.
15876728|NCT03829826|Biological|HyQvia|Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase
15876729|NCT03829813|Other|Music therapy|20 to 40 minute music therapy treatment session with a qualified music therapist.
15876730|NCT03829800|Dietary Supplement|Ensure® Abbott Nutrition|Effect of the intake of Ensure® Abbott Nutrition on the glycemic index, insulin, GLP-1, GIP levels and subjective appetite in subjects with type 2 diabetes
15876731|NCT03829800|Dietary Supplement|Glucerna® Abbott Nutrition|Effect of the intake of Glucerna® Abbott Nutrition on the glycemic index, insulin, GLP-1, GIP levels and subjective appetite in subjects with type 2 diabetes
15876732|NCT03829800|Dietary Supplement|Diasip® Nutricia Advanced|Effect of the intake of Diasip® Nutricia Advanced on the glycemic index, insulin, GLP-1, GIP levels and subjective appetite in subjects with type 2 diabetes
15876733|NCT03829800|Dietary Supplement|Glicolab®|Effect of the intake of Glicolab on the glycemic index, insulin and subjective appetite in subjects with type 2 diabetes
15876734|NCT03829787|Device|Eye tracking|Subjects will be assessed for attentional biases, reward sensitivity, and cognitive control using eye tracking technology
15876806|NCT03829345|Drug|Olaparib|Patients will be administered olaparib orally twice daily (BD) at 300mg continuously for each 28 day cycle.
15876735|NCT03829774|Device|Primary Relief v 2.0|The test product or device called Primary Relief v 2.0 will be used for the study. The study will be conducted for a period of two to three months with the treatment period of 3 - 4 days i.e single treatment (installation). The additional time taken will be to define the characteristics of the patient population and to recruit appropriate patients. Finally, there will be a data analysis and report writing period. Overall, the study is expected to 3 months. The device will be placed onto the auricle part of the ear for percutaneous electrical nerve stimulation.
15876736|NCT03829774|Drug|Paracetamol|A control group, receiving a standard treatment as follows: primary choice of analgesic was intravenous paracetamol, 1 gram, and if the pain relief was inadequate, diclofenac inj. If pain persisted in spite of these measures, 50 mg tramadol was administered intravenously
15876737|NCT03829761|Device|Repetitive transcranial magnetic stimulation (rTMS)|Repetitive transcranial magnetic stimulation (rTMS). Participants will undergo 10 daily sessions (Mon-Fri) of 30 minutes of 1Hz stimulation, for a total of 1800 pulses delivered.
15876738|NCT03829761|Device|Sham transcranial magnetic stimulation|Sham transcranial magnetic stimulation (TMS). Participants will undergo 10 daily sessions (Mon-Fri) of 30 minutes of sham stimulation. Sham stimulation will imitate the active rTMS but does not have active stimulation.
15876739|NCT03829748|Procedure|Intermittent aspiration|Endoscopic ultrasound is done for the localization of the lesion and to localize the site of puncture.Prior to the puncture of the lesion the stylet is removed and a vacuum syringe is prepared with 10 cc of vacuum allowing the generation of continous pressure inside and connected to the end of the needle. Once the lesion is punctured 15 movements in and out of the lesions will be made while the syringe is opened and closed on and off for a total of 3 times each pass. A total of 4 passes will be done in each lesion.
15876740|NCT03829735|Other|Human biological samples|Collection of capillary blood for HbsAg testing. Collection of 12 mL of blood for HbsAg positive women and 1 mL for HbsAg positive children.
15876741|NCT03829722|Drug|Nivolumab|Given intravenously (IV), 240 mg every 2 weeks for 4 doses concurrent with radiation therapy (RT). Following completion of RT, 480 mg given every 4 weeks for 4 doses.
15876742|NCT03829722|Drug|Carboplatin|Given IV once per week during radiation therapy (AUC=1).
15876743|NCT03829722|Drug|Paclitaxel|Given IV once per week during radiation therapy (30mg/m^2)
15876744|NCT03829722|Radiation|Radiation Therapy|Given 5 days/week for a total of 35 doses (70 gray total).
15876745|NCT03829709|Other|Rehabilitation|The first training session each week will be held at the LAERF under the direct supervision of the investigator and the other two home-based training sessions under the supervisor's distance supervision. They will receive the Threshold® IMT linear loading device, and guidelines for handling, posture and asepsis. The initial training load for each participant will be adjusted to 25% of PiMáx. Participants will be trained and instructed to do the exercise program on their own at home. Once a week, during the return to the laboratory the researcher will determine the new values for load (1st week 25%, 2nd week 35%, 3rd week 40%, 4th week 45%, 5th week 50%).
15876746|NCT03829696|Drug|Mifeprex® (Mifepristone 200 mg)|Participants will receive Mifeprex® (mifepristone 800 mcg) from a clinician when they are not pregnant. Participants who have an unintended pregnancy during the study period and would like to have a medication abortion will consult with a clinician for an over-the-phone evaluation of contraindications and gestational age. Participants who take the medications will be evaluated again in-person at a subsequent follow-up visit.
15876747|NCT03829696|Drug|Misoprostol 800 mcg|Participants will receive misoprostol from a clinician when they are not pregnant. Participants who have an unintended pregnancy during the study period would like to have a medication abortion will consult with a clinician for an over-the-phone evaluation of contraindications and gestational age. Participants who take the medications will be evaluated again in-person at a subsequent follow-up visit.
15876748|NCT03829696|Drug|ella® (ulipristal acetate emergency contraception 30 mg)|Participants will receive one dose of ella (emergency contraception) from a clinician at the same time of receiving mifepristone and misoprostol, in case the participant should have unprotected intercourse or failed contraception and want to prevent unintended pregnancy.
15876749|NCT03829696|Diagnostic Test|AccuHome® Pregnancy OTC Test|Participants will receive 6 AccuHome® pregnancy tests, which are midstream urine pregnancy tests and provide results within 3 minutes. Participants may request additional tests to be mailed to them by the study at any time.
15876750|NCT03829683|Drug|Vitamin C|200mg/kg/24hours
15876751|NCT03829683|Drug|Dextrose 5% in water|50mL intravenously every 6 hours
15876752|NCT03829670|Diagnostic Test|Cytochrome P450 test|Blood samples will be drawn for cytochrome P450 testing.
15876755|NCT03829644|Device|Horizon 627 Lumbar Brace, Aspen Medical Company, Oak Canyon, Irvine, CA 92618|The brace is an FDA Class I device, one-size adjustable design to fit waists ranging from 24-70 inches. Participants will be instructed to wear the brace for six weeks. As this brace is semi-rigid, it does not prevent motion - only reduces motion in the lumbar areas. Our prior work and that of others have shown that this type of bracing does not reduce spinal function and is not associated with atrophy.
15876756|NCT03829631|Device|Horizon 627 Lumbar Brace, Aspen Medical Company, Oak Canyon, Irvine, CA 92618|The brace is an FDA Class I, one-size adjustable design to fit waists ranging from 24-70 inches. Participants will be instructed to wear the brace for six weeks during the daytime
15876757|NCT03829618|Drug|Topical lidocaine|1% lidocaine topically applied in 4 mL aliquots
15876758|NCT03829618|Drug|Nebuliser solution|2% lidocaine dose at 2 mg/kg (max 160 mg) applied via jet nebulizer
15876759|NCT03829618|Drug|Nebuliser Suspension|2% lidocaine dosed at 2 mg/kg (max 160 mg) applied via vibrating mesh nebulizer
15876760|NCT03829605|Other|Measurement of hydrogen sulfide|Hydrogen sulfide will be measured by ELISA and correlated with nitric oxide and hyperglycemia
15876761|NCT03829592|Drug|misoprostol in a neutral media|giving misoprostol in a neutral media
15876762|NCT03829592|Drug|misoprostol in an acidic media|giving misoprostol in an acidic media
15876763|NCT03829592|Drug|misoprostol in an alkaline media|giving misoprostol in an alkaline media
15876810|NCT03829319|Biological|Pembrolizumab|IV infusion Q3W
15876764|NCT03829579|Drug|Esketamine|Participants will self-administer esketamine nasal spray, under the supervision of the healthcare professional at the site of care. A starting dose of 56 milligram (mg) will be administered intranasally into each nostril on Day 1 with subsequent doses of 56 mg or 84 mg administered during Weeks 1-4 (2 treatment sessions per week). For participants who respond, treatment is continued as follows: 56 mg or 84 mg of esketamine nasal spray during Weeks 5-8 (once weekly), and Week 9 onwards (every 2 weeks or once weekly), with period re-evaluation to determine the need for continued treatment. Doses will be adjusted based on efficacy and tolerability to the previous dosing.
15876765|NCT03829566|Drug|Rituximab|Monoclonal antibody therapy used to treat certain autoimmune diseases and types of cancer
15876766|NCT03829566|Drug|Cyclophosphamide|A medication used as chemotherapy and to suppress the immune system
15876767|NCT03829566|Drug|Mesna|A medication used in those taking cyclophosphamide or ifosfamide to decrease the risk of bleeding from the bladder
15876768|NCT03829566|Drug|rATG|A rabbit polyclonal antibody to lymphocytes
15876769|NCT03829566|Drug|Methylprednisolone|A corticosteroid medication used to suppress the immune system and decrease inflammation
15876770|NCT03829566|Drug|G-CSF|A glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream
15876771|NCT03829566|Biological|IVIg|Pooled immunoglobulin (IgG) from thousands of plasma donors that has immunomodulatory and anti-inflammatory effects
15876772|NCT03829566|Biological|Autologous Stem Cells|Infusion of patient's own stem cells
15876773|NCT03829553|Radiation|Hypofractionated radiotherapy|4005 cGy/ 15 fractions / 3 weeks to ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2.67Gy for 4 fractions in patients with intact breast
15876774|NCT03829553|Radiation|Conventional radiotherapy|5000 cGy/ 25 fractions / 5 weeks ipsilateral chest wall or whole breast and regional lymph regions (including supraclavicular and internal mammary lymph nodes) and sequential tumor bed boost of 2Gy for 5 fractions in patients with intact breast
15876775|NCT03829540|Biological|CD4CAR|CD4CAR cells transduced with a lentiviral vector to express the single-chain variable fragment (scFv) nucleotide sequence of the anti-CD4 molecule derived from humanized monoclonal ibalizumab and the intracellular domains of CD28 and 4-1BB co-activators fused to the CD3ζ T-cell activation signaling domain administered by IV infusions as a single dose (total dose of up to ~4x106 T Cells/KG)
15876776|NCT03829527|Behavioral|Psychotherapy|Psychological intervention combining a standardized treatment manual with a smartphone application
15876777|NCT03829514|Drug|Fenofibrate|40 patients (20 males and 20 females) aged 18-70 years, with type 2 diabetes and triglycerides >150 mg/dL will be recruited. They will have a physical exam and blood draw at visit 1. Participants will receive 160 mg fenofibrate to be taken orally daily for six weeks. They will return for a second visit after 6 weeks and have blood draw as follow up.
15876778|NCT03829501|Drug|KY1044|A human anti-ICOS monoclonal antibody
15876779|NCT03829501|Drug|KY1044 and atezolizumab|A human anti-ICOS monoclonal antibody in combination with anti-PD-L1 monoclonal antibody (atezolizumab)
15876780|NCT03829488|Drug|Plasma-Lyte 148 (approx. pH 7.4) IV Infusion|Plasma-Lyte 148 (approx. pH 7.4) IV Infusion is a sterile, clear, non-pyrogenic isotonic solution and when administered intravenously is a source of water, electrolytes and calories. Plasma-Lyte 148 intravenous infusion is indicated as a source of water & electrolytes or as an alkalinising agent.
15876781|NCT03829488|Drug|0.9% SODIUM CHLORIDE 9g/L injection BP|Sodium chloride (0.9% saline) infusion is a sterile, non-pyrogenic solution of sodium chloride in Water for Injections. The concentration of sodium chloride is 154mmol/L. Sodium chloride (0.9%) intravenous infusion is indicated for extra-cellular fluid replacement and in the management of metabolic alkalosis in the presence of fluid loss, and for restoring or maintaining the concentration of sodium and chloride ions.
15876782|NCT03829475|Drug|Bezlotoxumab|This is a a fully human monoclonal antibody that binds to C. difficile toxin B, and is indicated to prevent recurrence of CDI in adults at risk for recurrent CDI (rCDI).
15876783|NCT03829475|Drug|Placebo|placebo is an infusion of normal saline.
15876784|NCT03829475|Drug|Fecal Microbiota Transplantation|FMT is an infusion of prescreened donor stool that will be administered via colonoscopy
15876785|NCT03829462|Drug|Regorafenib|regorafenib tab 40 mg i.e 160 mg/day
15876786|NCT03829462|Drug|Irinotecan|irinotecan 120 mg/m2 cycle 1, 150 mg/m2 cycle 2, 180 mg/m2 cycle 3 and more
15876787|NCT03829449|Drug|rVA576 (Coversin)|The study population will consist of patients who have completed participation in clinical trials under other Akari protocols and who wish to continue to receive rVA576 (Coversin).
15876788|NCT03829436|Drug|Part 1 TPST-1120|Subjects will receive escalating doses of TPST-1120 administered orally twice daily continuously until MTD is reached or until disease progression
15876789|NCT03829436|Drug|Part 2 TPST-1120 + nivolumab|Subjects will receive escalating doses of TPST-1120 administered orally twice daily
15876790|NCT03829436|Drug|Part 3 TPST-1120|Selected dose of TPST-1120 administered orally twice daily until disease progression
15876791|NCT03829436|Drug|Part 4 TPST-1120 + nivolumab|Selected dose of TPST-1120 administered orally twice daily in combination with nivolumab administered intravenously every 28 days until MTD is reached for TPST-1120 or until disease progression
15876792|NCT03829423|Diagnostic Test|Breast MRI interpretation|Analysis and interpretation of breast MRI sequences by a specially developed breast MRI interpretation algorithm
15876793|NCT03829410|Drug|Onvansertib|Onvansertib orally.
15876794|NCT03829410|Biological|Bevacizumab|Bevacizumab intravenously.
15876795|NCT03829410|Drug|FOLFIRI|FOLFIRI intravenously.
15876796|NCT03829397|Diagnostic Test|Questionnaire|Questionnaire
15876797|NCT03829384|Biological|mRNA-1944|mRNA encoding Chikungunya antibody
15876798|NCT03829384|Other|Placebo|Saline
15876799|NCT03829371|Drug|Velcade|Subcutaneous use
15876800|NCT03829371|Drug|Melphalan|Oral use
15876801|NCT03829371|Drug|Prednisone|Oral use
15876802|NCT03829371|Drug|Lenalidomide|Oral use
15876803|NCT03829371|Drug|Dexamethasone|Oral use
15876804|NCT03829358|Drug|Lactobacillus plantarum IS-10506|Fermented milk containing probiotic Lactobacillus plantarum IS-10506 to be consumed once daily for three weeks.
15876805|NCT03829358|Drug|Placebo|Fermented milk containing placebo to be consumed once daily for three weeks.
15876816|NCT03829293|Device|High-flow nasal cannula oxygenation group|usual care + High-flow nasal oxygenation (HFNO) therapy during GI endoscopy under sedation (with a flow at 70L/min and FiO2 50%) through a dedicated system, the THRIVETM (Fisher&Paykel, New-Zealand)
15876817|NCT03829280|Behavioral|Cognitive Adaptation Training|Psychosocial treatment using environmental supports to bypass cognitive and motivational problems and improve adaptive behavior
15876818|NCT03829280|Behavioral|Community Treatment|Medication follow-up and case management as provided in usual community care in the setting
15876819|NCT03829267|Behavioral|eFIT Intervention|eFIT: social network accountability partners, a psychosocial intervention to increase physical activity in persons with multiple sclerosis
15876820|NCT03829267|Behavioral|eJournal Intervention|1-hour online each week engaged in an active journaling activity
15876821|NCT03829267|Behavioral|Treatment as usual|Participants in this condition will complete baseline and follow-up surveys with the same frequency as the active treatment groups, but will receive neither eFIT nor eJournal.
15876822|NCT03829254|Drug|NUC-7738|NUC-7738
15876823|NCT03829241|Drug|Troriluzole|100mg capsule
15876824|NCT03829241|Drug|Placebo|100mg capsule
15876826|NCT03829215|Device|CAERVest cooling device|The CAERVest device will be filled and placed on the supine patient's chest immediately after return of spontaneous circulation. After admission to the emergency department, the device will be removed, when a temperature below 34°C is reached.
15876827|NCT03829202|Device|Own mechanical knee|Daily use of own mechanical knee
15876828|NCT03829202|Device|RheoKnee microprocessor prosthetic knee|Daily use of RheoKnee microprocessor prosthetic knee
15876829|NCT03829189|Dietary Supplement|inulin|prebiotic supplement
15876830|NCT03829189|Dietary Supplement|maltodextrin|placebo supplement
15876831|NCT03829176|Genetic|Whole Genome Sequencing|Participants in this arm will have their sample analyzed by whole genome sequencing (WGS), and a report will be included in their medical record. Analysis will be phenotype-driven (gene list will be curated based on primary indication for testing and other available medical history information), and may include genes on ACMG 59 list if participant elects for these results. This report will include pathogenic, likely pathogenic, and suspicious VUS results identified in the genes analyzed.
15876832|NCT03829163|Device|Hydraulic Adjustable Walker|The HAW is a based on a conventional walker but has innovative telescoping legs with a leg adjustment assembly that includes at least one valve and at least one tube that delivers hydraulic fluid into the legs and allows a user to control the length of each leg. The legs of the walker are hydraulically adjustable, so that the front legs may be shortened and the back legs extended, or two side legs shortened and the two opposing side legs extended, so as to allow the walker to be securely placed on two different steps. This allows the user to be able to stand on a stair without worrying about sharing the same stair with the device. It also ensures that the height of the walker continues to be the right height for the user to minimize loss of balance.
15876833|NCT03829163|Device|Conventional Walker|A walker consists primarily of a metal frame with four legs which are stabilized by crossbars. These walker frames come in a variety of shapes and sizes; many consist primarily of two inverted U-shaped leg modules connected by crossbars. Regardless of the shape or form of the leg modules, each walker frame forms a 3-sided box with an opening in which the user may stand.
15876834|NCT03829150|Drug|Dexlan|Dexlansoprazole MR 60 mg qd for 7 days
15876835|NCT03829150|Drug|Amoxicillin|Amoxicillin (Amolin) 1 g bid. for 7 days
15876836|NCT03829150|Drug|Clarithromycin 500mg|clarithromycin (Klaricid) 500 mg bid for 7 days
15876837|NCT03829150|Drug|Metronidazole|Metronidazole (Flagyl) 500 mg bid daily for 7 days
15876838|NCT03829137|Device|Verum laser acupuncture|The patients lay in the supine position before treatment and the gallium aluminum arsenide LaserPan (RJ-Laser, Reimers & Janssen GmbH, Waldkirch, Germany) will be applied to each selected acupoints for 3 weeks, total of 9 sessions.
15876839|NCT03829137|Device|Sham laser acupuncture|The acupuncture points and procedure of the control group are identical to the experimental group but there are no laser beam energy.
15876840|NCT03829124|Drug|Propofol|Propofol 10mg/ml IV push slowly 0.5-2mg/kg
15876841|NCT03829124|Drug|Ketamine|Ketamine 50mg/ml IV push slowly 0.5- 1mg/kg
15876842|NCT03829111|Drug|Clostridium butyricum CBM 588 Probiotic Strain|Given PO
15876843|NCT03829111|Biological|Ipilimumab|Given IV
15876844|NCT03829111|Biological|Nivolumab|Given IV
15876845|NCT03829098|Other|Intervantions for anastomotic leakage after esophagectomy|nil by mouth regime; antibiotic treatment according to local protocols; NG tube placement (with/without suction); NG tube repositioning (with/without suction); tube placement though anastomotic defect; endoVAC/endoSponge placement; stent placement (stent type if applicable); endoscopic clipping; nasoduodenal/nasojejunal feeding tube placement; radiologic drainage (thoracic cavity, mediastinum); bedside surgical chest tube placement; reoperation; reoperation approach; reoperation procedure (drainage only, suturing of the leak; resection of the leak and re-anastomosis; repair of anastomosis with muscle flap; disconnection and cervical esophagostomy; surgical jejunal feeding tube).
15876846|NCT03829085|Other|EARLY ORAL REFEEDING|the oral refeeding will be started after admission. Patients will receive a low fat solid diet with more and less 1500 calories, 35 g fat day
15876847|NCT03829072|Other|Cooking Education|cooking Education and adapted physical activity on patients after allo stem cell transplantation
15876848|NCT03829072|Other|adapted physical activity|cooking Education and adapted physical activity on patients after allo stem cell transplantation
15876849|NCT03829046|Drug|Placebo|12 weeks of treatment
15876850|NCT03829046|Drug|Evolocumab|12 weeks of treatment
15876851|NCT03829033|Radiation|Radiotherapy|Radiotherapy with either photons or protons.
15876852|NCT03829020|Drug|Bortezomib|Given SC
15876853|NCT03829020|Drug|Metformin Hydrochloride|Given PO
15876854|NCT03829020|Drug|Nelfinavir Mesylate|Given PO
15876855|NCT03829007|Diagnostic Test|PD-L1 imaging|89Zr-durvalumab injection followed by a PET/CT scan 5 days after injection
15876857|NCT03828994|Behavioral|Tech-PN|"text messaging(daily medication reminders and tri-weekly messages following the 14-day treatment period)
~enhanced community health nurse visits on day 3-5, 14 and 30
~field based treatment visits
~clinical assistance with notification, testing and treatment"
15876858|NCT03828981|Procedure|fast-track recovery program|"Pre-operative: fast-track management counseling, fast-track educational video,tobacco cessation, daily physical activity, light meal 6 hours and clear liquids up to 2 hours before surgery, no bowel preparation, a warm blanket, medication.
~Intra-operative: vaginal wound infiltrative anesthesia, early remove of urine catheter.
~Post-operative: early oral intake liquids and food, early mobilization, avoiding opioids by use of pregabaline for postoperative pain."
15876859|NCT03828968|Diagnostic Test|bladder scan|Measurement of vesical volume by bladder scan
15876860|NCT03828955|Dietary Supplement|Soybean peptides|Subjects receive two bags soybean peptides per day for 8 weeks of a stage. Anthropometric measurements such as blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), body weight, body fat, waistline, hipline and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST and ALT were measured every four weeks.
15876861|NCT03828955|Dietary Supplement|Placebo|Subjects receive two bags of starch placebo of similar appearance per day for 8 weeks of a stage. Anthropometric measurements such as blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), body weight, body fat, waistline, hipline, and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST, and ALT were measured every four weeks.
15876862|NCT03828942|Drug|drug inducing hematological toxicity|Drugs susceptible to induce hematological toxicities
15876863|NCT03828929|Drug|Vitamin C|IV vitamin C, 1500mg in 50ml of normal saline every six hours, infused over one hour and IV Thiamine 200mg in 50ml of 5% dextrose every 12 hours, for 4 days or until discharge from the intensive care unit, whichever comes first.
15876864|NCT03828929|Drug|Normal saline|50ml of IV normal saline every six hours and 50ml of IV 5% dextrose every 12 hours, for 4 days or until discharge from the intensive care unit, whichever comes first.
15876865|NCT03828916|Other|NuShield|SOC surgery with the addition of NuShield
15876866|NCT03828903|Device|Cryoprobe|"The probe (ERBE Elektromedizin GmbH; Tubingen, Germany of 2.4mm) will be placed perpendicular to the surface of the parietal pleura with the tip of the probe extended well beyond the tip of the scope using the marking on the probe and with direct visualization.
~The tip of the cryoprobe will be attached to suspicious part of parietal pleura .
~The frozen tissue is going to be extracted by gently pulling of the probe.
~Freezing will be carried out for 6 to 10 seconds depending on the visual assessment of pleural texture.
~The probe with the attached biopsy sample is going to be removed together with the thoracoscope through trocar.
~The biopsy sample will be released from the probe by thawing in the saline.
~The semirigid pleuroscope will be reintroduced through the port and the pleura will be revisualized for bleeding."
15876867|NCT03828890|Other|Screening eye exam using Optos technology|Retinal imaging using Optos technology to identify Diabetic Retinopathy
15876868|NCT03828877|Other|Group A ( Group Acupuncture)|Group A; Acupunctur will be done with Pres Needle (0.22x1.5 mm).Acupuncture will be done points fo SP 6, LI 4 , ST 36 , LİV 3, LU 9 ,LU 7.
15876869|NCT03828864|Device|Pulsed Shortwave Therapy|Pulsed Shortwave Therapy device placed over the site of pain for 16 hrs per day
15876870|NCT03828864|Device|Placebo Pulsed Shortwave Therapy|Placebo Pulsed Shortwave Therapy device placed over the site of pain for 16 hrs per day
15876871|NCT03828851|Other|Domiciliary care - Activities of Daily Living|Home-based ADL training.
15876872|NCT03828838|Drug|Lu-177 PSMA-617|Two cycles of Lu-177 PSMA (3GBq and 3-6 GBq)
15876873|NCT03828825|Other|Patent Foramen Ovale closure|"The Patent Foramen Ovale closure is realized under trans-thoracic echocardiography control. If necessary, the operator will use trans-esophageal echocardiography to implant the prosthesis. One day after the procedure, a clinical assessment and an electrocardiogram are performed. At 3 months the consultation corresponds to a trans-thoracic echocardiography validation of the closure accompanied by a bubble test (Valsalva maneuver) and a clinical assessment. At 12 months, the visit corresponds to a consultation with a clinical assessment and an electrocardiogram. At 36-months and 60-months, the visits will be done following the on-site visits provided for in the usual care or during a telephone call from the attending cardiologist to retrieve the results of the clinical examination, electrocardiogram and MACCE (major cardiac and cerebral vascular events). A consultation dedicated to the study may be proposed to patients according to what is provided in the usual care."
15876874|NCT03828812|Behavioral|Breakfast promotion|Recommendation of having breakfast daily
15876875|NCT03828812|Behavioral|Nighttime snack reduction|Recommendation of reducing frequency of nighttime snacking
15876876|NCT03828799|Combination Product|Folfirinox + regorrafenib|folfirinox : from day 1 to day 3 regorafenib : day 4 to day 10 a cycle during 14 days
15876877|NCT03828786|Procedure|Endometrial scratching|Endometrial Biopsy by aspiration with a pipelle
15876878|NCT03828773|Drug|Posaconazole|Posaconazole is a triazole with broad-spectrum activity, to include Candida species, Aspergillus species, and other fungal pathogens, including the Zygomycetes. Posaconazole is available as slow release tablets (300mg/day) and as intravenous (IV) formulation (300mg/day) and is licensed and approved in Switzerland for the prevention of IFI, including mold and yeast infections, in patients >18 years who are at high risk of developing these types of infection (patients with long-term neutropenia or HCT recipients). Furthermore, international guidelines recommend posaconazole for primary antifungal prophylaxis in high-risk patients, such as AML patients with prolonged neutropenia. Posaconazole is available in Switzerland under the name of Noxafil® in capsules of 100mg, suspension of 40mg/mL and intravenous formulation of 300mg/16.7 mL.
15876879|NCT03828773|Drug|Fluconazole|Fluconazole is an antifungal with activity against most Candida species. Fluconazole is licensed and approved in Switzerland for prophylaxis of IC in patients with neutropenia induced by chemotherapy or radiotherapy at a daily dose of 200 to 400 mg once daily. Fluconazole (200 mg or 400 mg once daily) is still currently used as primary antifungal prophylaxis (standard of care) in all 7 centers participating in this trial. Fluconazole is available in Switzerland under the name of Diflucan® in capsules of 50 mg, 150 mg and 200 mg and in powder for preparation of suspension (50 mg/5 ml and 200 mg/5 ml (forte)) or perfusion (2 mg/1 ml). Several generics of Diflucan® are authorized in Switzerland. Prescribing Diflucan® or any of its generics will remain at the discretion of and based on the standard operating procedures (SOP) at each institution.
15888866|NCT03736616|Drug|Cytarabine|Chemotherapy
15876880|NCT03828760|Behavioral|Music listening|Patients will be asked to either use their personal phones to listen to preferred music which is already on their device, or if they do not have a phone or other personal device capable of playing music of their choice, we will use a device (e.g. iPod) to load music of their choice. While in the waiting room, participants will listen to music through headphones/earphones, however they will need to remove their headphones/earphones during the initial consultation with the family physician (explaining risks, etc.), and resume listening to music through the phone speakers once in the examination room as patients will need to be able to hear instructions from the physician during the procedure.
15876884|NCT03828734|Device|Theta TMS|TMS will be administered at the frequency of each subject's endogenous theta oscillation (4-7Hz)
15876885|NCT03828734|Device|Alpha TMS|TMS will be administered at the frequency of each subject's endogenous alpha oscillation (8-12 Hz)
15876886|NCT03828734|Device|Arrhythmic TMS|TMS will be administered arrhythmically; i.e. a sequence of pulses with randomized timing
15876887|NCT03828721|Other|Rx for Success Smartphone Application|"The Rx for Success (RS) mobile application (app) was developed by the non-profit, Children, Inc. The app is designed to be informational and motivational with both video and cueing content. The app uses a View It, Cue It, Do It model that allows parents to quickly download the smartphone app, view brief videos of age-indexed, research-based language enrichment practices; and regulate a push notification cueing program. Videos embedded in the RS app provide a summary of dialogic reading tailored for the child's age, and suggestions for encouraging verbal interactivity and social-emotional engagement through dialogic reading. Key behaviors reinforced by the app include discussing the story before reading to build interest and enthusiasm, followed by interactive reading modeled by specific types of verbal/behavioral prompts for the parent to make and responses to what the child says or does."
15876888|NCT03828721|Other|Control - screen time reduction|Control families will receive a new, specially designed children's book regarding limiting screen-based media use and encouraging healthy/active alternatives (Baby Unplugged: Play, Hutton/Jones, blue manatee press), which lists American Academy of Pediatrics screen time recommendations on the back cover.
15876889|NCT03828708|Other|Iron in infant formula|Participants will receive the same low-iron (5 mg/L) infant formula. Infants in the standard iron group will add iron supplement to pre-made infant formula so the iron content will be 12 mg/L.
15876890|NCT03828695|Other|uterocervical angle|uterocervical angle is the angle between lower segment of uterus and cervix
15876891|NCT03828682|Drug|Tacrolimus Extended Release Oral Tablet [Envarsus]|Tacrolimus Extended Release Oral Tablet [Envarsus]
15876892|NCT03828682|Drug|Mycophenolate Mofetil|Mycophenolate mofetil capsules or tablets
15876893|NCT03828682|Drug|Mycophenolic Acid Oral Product|mycophenolic acid tablets
15876894|NCT03828682|Drug|Tacrolimus|Twice daily tacrolimus
15876895|NCT03828682|Drug|Methylprednisolone|Methylprednisolone taper
15876896|NCT03828682|Drug|Prednisone|Prednisone taper
15876897|NCT03828682|Drug|Rabbit Anti-Human T-Lymphocyte Globulin Injectable Solution [Thymoglobulin]|Rabbit Anti-Human T-Lymphocyte Globulin
15876898|NCT03828669|Behavioral|Recovery Toolkits|"Recovery Toolkits are presented to patients in a branded bag and include a brochure, a self-help behavioral pain medicine book, a downloadable app, earbuds, and access to digital behavioral medicine (the My Surgical Success program including online educational videos)"
15876899|NCT03828656|Device|NightWare Therapeutic System|A wearable digital therapeutic system that will measure physiologic data when worn during sleep to deliver a mild vibration via the watch to elicit arousal thereby disrupting nightmares. This detection and stimulation sequence will be performed according to NightWare's proprietary algorithm.
15876900|NCT03828643|Drug|Secukinumab|Secukinumab 300 mg without loading dose at weeks 0, 1, 2, 3 and 4.
15876901|NCT03828643|Drug|Secukinumab|Secukinumab 300 mg with loading dose at weeks 0, 1, 2, 3 and 4.
15876902|NCT03828617|Biological|20vPnC|20vPnC
15876903|NCT03828617|Biological|20vPnC|20vPnC
15876904|NCT03828617|Biological|20vPnC|20vPnC
15876905|NCT03828617|Biological|13vPnC|Pneumococcal conjugate vaccine
15876906|NCT03828604|Behavioral|Stress; Trier Social Stress Task|Standardized acute psychosocial stressor
15876907|NCT03828604|Behavioral|Placebo Trier Social Stress Task|Active control version of the TSST
15876908|NCT03828591|Procedure|Intensive psychological support|Two meeting with a psychologist during the hospitalization (the first two days after surgery; the second one at the moment of the hospitalization discharge)
15876909|NCT03828591|Procedure|Standard psychological support|Two meetings with a psychologist: the first meeting is one month before surgery; the second meeting is one month after surgery
15876910|NCT03828578|Procedure|High flow oxygen therapy|High flow oxygen therapy delivered via Airvo2
15876911|NCT03828565|Procedure|ScvO2 Perioperative continue monitoring|"ScvO2 Perioperative continue monitoring with PreSep® system. If SvcO2 is less than 65% or decreases by more than 10% of its base value, the other parameters affecting ScvO2 (BIS (40-60% objective), Hb (objective> 8g / dL), SaO2 (objective> 94%)) are evaluated. If, after correcting for these parameters, the ScvO2 is not corrected, the preload-dependence parameters are evaluated (variation of the pulsed pressure) to guide the vascular filling: VF of 250 mL of crystalloids if PPV> 13%, norepinephrine if PPV<9%, reassess if PPV between 9 and 13%.
~If VF or norepinephrine does not correct ScvO2 (> 65%), a measurement of arterial lactate is performed. If lactatemia is> 2 mmol / L, a positive inotrop is introduced after ETO if possible. If lactatemia is <2 mmol / L, a return to the evaluation phase of the parameters influencing ScvO2 is necessary."
15876987|NCT03827941|Other|20 Hz Auricular transcutaneous electrical nerve stimulation|High-functioning individuals with autism randomized to this group will receive 1 Hz tVNS stimulation for 30 minutes/day up to 5 times/week for 3 weeks.
15876912|NCT03828552|Other|Questionnaire|"Parents will be recruited in a Pediatric Resuscitation Department of the Mother and Child Hospital for 3 months. The doctor taking care of a child and his parents meeting the eligibility criteria will distribute, during the stay, a questionnaire accompanied by a pre-stamped envelope to the two parents not opposing the study.
~A phone call and / or an email reminder by the intern in the month of the exit will invite each parent to return the questionnaire.
~The completed questionnaire will be mailed back by the parents using the pre-stamped envelope."
15876913|NCT03828539|Biological|Erenumab|70mg/1mL (70 mg) or 2x70mg/1mL (140 mg) in pre-filled syringe, administered every 4 weeks
15876914|NCT03828539|Drug|Topiramate|"Film-coated tablet taken orally:
~25 mg administered once daily (first week of titration phase). After the first week, titration was done according to the summary of product characteristics (SmPC) in 25 mg increments each week and aimed to reach the recommended daily treatment dose of 100 mg (50/75/100 mg). 50/75/100 mg were administered twice daily during titration phase and maintenance phase."
15876915|NCT03828539|Biological|Erenumab matching placebo|Erenumab matching placebo pre-filled syringue administered every 4 weeks
15876916|NCT03828539|Drug|Topiramate matching placebo|Topiramate matching placebo administered daily
15876917|NCT03828526|Other|High Fidelity Simulation|Teaching strategy based on high fidelity simulation, which simulates the reality of health care to promote meaningful learning.
15876918|NCT03828526|Other|Traditional teaching strategy|Classroom-based strategy
15876919|NCT03828513|Device|High flow nasal cannula oxygen is applied|Atelectasis evaluation with lung ultrasound is performe and score in 6 different areas before and after High flow nasal cannula oxygen. Pulmonary function tests and blood gas parameters are compared.During the procedure, the patient's blood pressure, heart rate, oxygen saturation, any complications that may develop will be recorded.Induction of anesthesia; difficult airway management, difficult mask and / or difficult intubation incidence, Mallampati scores, the use of one of the difficult intubation techniques during intubation, perioperative mechanical ventilation parameters (ventilation mode, tidal volume, respiratory frequency, end of tidal CO2 (carbon dioxide) pressure, PEEP usage, SpO2 (saturation oxygen), airway peak pressure, urine volume, arterial blood gas parameters are recorded.
15876920|NCT03828513|Device|High flow nasal cannula oxygen is not applied|Apply preoxygenation with facemask. Prior to induction of general anesthesia, preoxygenation will be applied with an oxygen supplement of 5 l / min to an endtidal O2> 90%.Atelectasis evaluation with lung ultrasound is performe and score in 6 different areas before and after preoxygenation.
15876921|NCT03828500|Behavioral|Assistant-encouraged fasting up to ASA/CAS guideline limits|Research Assistant encourages patient to drink clear fluids up to 2 hour limit before surgery, in accordance with the latest ASA and CAS guidelines.
15876922|NCT03828487|Device|Masimo O3 Neonatal Sensors|Regional Oximetry sensor for Neonates
15876923|NCT03828487|Device|510(k) cleared sensor|Cleared Regional Oximetry sensor for Neonates
15876924|NCT03828474|Drug|Acetazolamide Pill|Acetazolamide pill
15876925|NCT03828461|Behavioral|Facilitated group therapy with behavioral practice; 16 weeks|Facilitated group therapy for hoarding disorder with behavioral practice
15876926|NCT03828448|Drug|Ublituximab|- anti-CD 20 monoclonal antibody administered via IV infusion
15876927|NCT03828448|Drug|Umbralisib|- PI3K Delta Inhibitor oral daily dose
15876928|NCT03828435|Device|rTMS|Magnetic stimulation will be given using a hand-held figure-of-eight coil with an median winding diameter of 70 mm or a cone coil (Magstim Co., Whitland, Dyfed, UK) connected to one Magstim Rapid2 Package (Magstim Co., UK). The figure-of-eight coil will be placed tangentially to the scalp with the handle pointing backwards, which is thought to preferentially activate the corticospinal cells trans-synaptically (Kaneko et al., 1996), while the cone coil will be placed along the anterioposterior axis to induce a posterior-to-anterior current in the cortex.
15876929|NCT03828422|Diagnostic Test|imaging|
15876930|NCT03828409|Procedure|Short stitch|The rectus sheath are cleaned off the subcutaneous fats. Short stitch technique uses smaller needle and suture material. The suture is placed nearer to each other as compared to our conventional long stitch technique. It has inter-suture distance of 5mm and 5mm distance from rectus edge. The suture will be started at one end and sutured continuous until the other end. Hence, this technique is applied without tension.
15876931|NCT03828409|Procedure|Long stitch|Long stitch uses a larger needle and suture material. The suture is placed 1cm from the linea alba and 1 cm from previous suture. This technique include mass closure sutures at the midline laparotomy
15876932|NCT03828383|Device|In-home technology|Intelligent bots monitor the in-home sensors, learn typical patterns, and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome behaviors occur. Social contact is encouraged using a trusted circle of friends and family who are encouraged to stay in contact and share photos and videos with the caregiver and person with dementia via the digital display.
15876933|NCT03828383|Device|Limited in-home technology|Intelligent bot monitors the in-home water leak sensor and provide caregivers with text messages via cell phone and alerts via the tablet when worrisome conditions occur.
15876934|NCT03828370|Behavioral|B-SMART Intervention Group|The B-SMART mobile web app will contain four modules: 1) Supporting Abstinence, 2) Shared Positive Activities, 3) Common Challenges for Family Members with IID, and 4) Effective Communication. Within each module there will be a series of learning activities, including presentation text, interactive engagement, and videos. All app content will be available in both English and Spanish, based on user language preference.
15876935|NCT03828370|Behavioral|Usual and Customary Information Group|Participants randomized to the usual and customary care (UC) group will receive a website with a pamphlet on the IID installed in their vehicle and the manufacturer information provided about the IID in PDF format, in both English and Spanish. This constitutes a UC group, as such pamphlets are widely available to DWI offenders who have IIDs installed in their vehicles. Thus, providing this pamphlet represents a standard information provision for first-time DWI offenders and their CFMs.
15876936|NCT03828357|Other|Study MRI scan|At least forty-five (45) days after system implantation or after a system revision, Subjects will undergo a study-related MRI scan at 1.5T.
15876937|NCT03828344|Biological|hUC-MSC suspension|Patients will be treated at dose of 0.75×10^6 cells/kg of body weight (Cohort 1) or 1.5×10^6 cells/kg of body weight (Cohort 2) via a single IV infusion using a blood transfusion kit.
15876938|NCT03828344|Biological|Placebo|Placebo contains the same cell suspension as BX-U001 but without cells.
15876939|NCT03828331|Other|Prosthetic/Bicycle Configuration|The investigators will measure the biomechanics (motion, forces, and muscle activity) and metabolic rates while subjects ride using an initial bike fit and three taller pylon lengths (PL) for the affected leg (AL) in increments of 6.8 mm using a pedal attachment position (PAP) beneath the prosthetic forefoot. Then, using the optimal (most efficient) PL, the investigators will measure the biomechanics and metabolic rates while subjects ride using three shorter crank arm lengths (CALs) for the AL in decrements of 6.8 mm using a PAP beneath the prosthetic forefoot. On Day 2, the investigators will repeat the protocol of Day 1, but have riders use a PAP beneath the pylon for their AL.
15876940|NCT03828318|Other|Patient Activation Booklet and nursing support for patients with LARS|The LARS Patient-Centered Program will consist of an educational booklet and nursing support made available only to patients randomized to the intervention group.
15876941|NCT03828305|Other|Training and creation of the Network-CPR|Training and creation of the Network-CPR that will cover the city. This network will be created with certain population groups that are routinely in contact with susceptible persons of OHCA (police, firemen, teaching staff, health personnel, merchants, pharmacists, university students, etc.), in addition, relatives of people with heart disease will be included. In the case of elderly people who are alone, they will include their neighbors or caregivers. In the city, there are 2,105 people with heart disease susceptible to OHCA. The research team and the health personnel of the participating primary care centers (PCC) will offer training courses on basic CPR maneuvers and use of the AED, following the protocol of the Center Català de Ressucitació (CCR). The training is aimed at training 430 people (20% of the relatives of people with heart disease) and will be made by trainers accredited by the CCR. There will be a total of 30 sessions with groups of approximately 15 people.
15876942|NCT03828305|Other|Control Group|No intervention
15876943|NCT03828292|Drug|Belantamab mafodotin|Belantamab mafodotin will be administered as an intravenous infusion.
15876944|NCT03828292|Drug|Bortezomib|Bortezomib solution for injection will be administered subcutaneously.
15876945|NCT03828292|Drug|Dexamethasone|Dexamethasone tablets will be administered orally.
15876946|NCT03828292|Drug|Pomalidomide|Pomalidomide capsules will be administered orally.
15876947|NCT03828279|Diagnostic Test|functional and antigenic C1 inhibitor|Diagnosis of HAE is based on personal and/or family history of angioedema and on C1 inhibitor functional or antigenic plasma levels ≤50% of normal.
15876948|NCT03828266|Other|No intervention|Patients will undergo routine clinical practice. There is no additional intervention.
15876949|NCT03828240|Other|HIP fracture REhabilitation Programme for the elderly with hip fractures|Eight-week activity-based intervention for elderly with hip fractures; one intervention during the hospital stay, four interventions at the elderly's municipality.
15876950|NCT03828227|Drug|OPTIMOX plus bevacizumab|"Adapted FOLFOX7 (aFOLFOX7)-bevacizumab for 6 cycles
~Bevacizumab: 5 mg/kg IV (day 1, every 2 weeks (q2w)),
~Folinic acid (FA): 400 mg/m² IV/2h (day 1, q2w),
~Oxaliplatin: 85 mg/m² IV/2h (day 1, q2w),
~5-FU continuous infusion 2400 mg/m² IV/46h (day 1-2, q2w),
~No 5-FU bolus.
~then Adapted LV5FU2 (aLV5FU2)-bevacizumab (until progression or or unacceptable limiting toxicity)
~Bevacizumab: 5 mg/kg IV (day 1, q2w),
~FA: 400 mg/m² IV/2h (day 1, q2w),
~5-FU continuous infusion 2400 mg/m² IV/46h (day 1-2, q2w)
~No 5-FU bolus"
15876951|NCT03828227|Drug|Capecitabine plus bevacizumab|"Bevacizumab: 7.5 mg/kg intravenous infusion [IV] (day 1; q3w),
~Capecitabine: 1000 mg/m² orally twice a day (day 1 through day 14, q3w)."
15876952|NCT03828214|Device|Robotic exoskeleton for walking assist|Participants will have two testing sessions in this within-subject design experiment. The conditions under which walking will be evaluated are control (normal) walking, walking with the exoskeleton assistance and walking immediately following exoskeleton walking. The conditions under which stair walking (ascending and descending) will be evaluated include control (normal) stairs and exoskeleton assisted stairs. Assistance is provided by The Honda Walking Assist (HWA) System is a robotic device developed by Honda R&D Corporation ®, Japan. The devices computer-activated motors use hip angle information to guide assistance delivered through the thigh straps to the legs in time with the walking cycle. The maximum torque delivered is 4 Newton-meters.
15876953|NCT03828201|Drug|Delamanid|"Frequency: daily Route of administration: oral
~Delamanid is a medication used to treat tuberculosis. Specifically it is used, along with other antituberculosis medications, for active multidrug-resistant tuberculosis. It is taken by mouth."
15876954|NCT03828201|Drug|Levofloxacin|"Frequency: daily Route of administration: oral
~Levofloxacin is an antibiotic used to treat a number of bacterial infections including acute bacterial sinusitis, pneumonia, urinary tract infections, chronic prostatitis, and some types of gastroenteritis. Along with other antibiotics it may be used to treat tuberculosis."
15876955|NCT03828201|Drug|Bedaquiline|"Frequency: daily Route of administration: oral
~Bedaquiline is indicated for use as part of an appropriate combination regimen for pulmonary multidrug-resistant tuberculosis (MDR-TB) in adult patients when an effective treatment regimen cannot otherwise be composed for reasons of resistance or tolerability."
15876956|NCT03828201|Drug|Clofazimine|"Frequency: daily Route of administration: oral
~Clofazimine has shown activity against multidrug-resistant tuberculosis (MDR-TB) and is now recommended by the World Health Organization (WHO) to treat drug resistant tuberculosis as a Group B drug. It is thought that clofazimine acts by inhibiting the formation of matrixes within the DNA and thus delaying the growth of the bacterium. Clofazimine first received FDA approval in 1986, although its use in the treatment of MDR-TB has not been approved by any stringent regulatory authorities and it is therefore used off-label for this function."
15876957|NCT03828201|Drug|Linezolid|"Frequency: daily Route of administration: oral
~Linezolid is an antibiotic used for the treatment of infections caused by Gram-positive bacteria that are resistant to other antibiotics."
15876958|NCT03828188|Dietary Supplement|Red Ginseng Concentrated Powder|Red Ginseng Concentrated Powder(4.9 g/day) for 12 weeks.
15876959|NCT03828188|Dietary Supplement|Placebo|Placebo for 12 weeks.
15876988|NCT03827928|Behavioral|Yoga/meditation|A 6-week yoga and meditation program with psychoeducation components, delivered through community-based yoga sessions. This program offers structured instruction: 10 minutes of breathing exercises to calm the nervous system, 45 minutes of gentle yoga to improve strength, flexibility, and balance, 15 minutes of guided meditation to enhance attention control, emotional regulation, and self-efficacy, and 20 minutes of facilitated discussion with psychoeducation to build community connection and skills in resilience.
15877378|NCT03824743|Drug|Plasma-lyte|Patients managed with Plasma-Lyte and obstetric hemorrhage
15876960|NCT03828175|Procedure|spinal anesthesia monitoring|"After attaching all standard monitors (ECG, NIBP, pulse oximeter) and the COP bio-impedance monitor recording basal data (COP, CI, SV, CPI, Do2, DO2I, SVR, SVV.
~During sitting position intrathecal anesthesia was conducted in the sitting position under complete aseptic condition using heavy bupivacaine 15mg (3ml) plus 10 mic dexamedatomedine 25G needle after 2 ml Lidocaine skin infiltration. lithotomy position till anesthesia level documented T4 and fixed and lower urinary tract endoscopy then shifting the patient to prone position and after adjustment of the prone position precautions 2 bellows one under the chest and one under the pelvis with pliable free moving abdomen jell ring under the patient head knees and in front of heels, then the basal data recording and after that data recording every 10 minutes till end of the operative procedure. Blood sampling at basal, postoperative"
15876961|NCT03828162|Drug|Anticoagulants|
15876962|NCT03828149|Combination Product|Drug:OP0201|Drug: OP0201
15876963|NCT03828149|Combination Product|Drug: Placebo|Drug: Placebo
15876964|NCT03828136|Device|Novum Vitrium® Cervical Interbody Device|For spinal fusion procedure at one level (C3 to T1) of the cervical spine.
15876965|NCT03828136|Device|Allograft Ring or Block|Standard of Care
15876966|NCT03828123|Biological|Suspension of human autologous MSC 3P in 1.5 ml|Intrathecal application of Autologous Multipotent Mesenchymal Stromal Cells 3P suspension
15876967|NCT03828110|Device|Robotic Assisted Gait Training (Lokomat)|The RAGT treatment consisted of sessions lasting 45 minutes each performed with the commercially available Lokomat device. The same exercises were offered to the children with preset duration, speed, and difficulty. For all patients, the initial body-weight support was set at 50%, and was then gradually decreased according to the individual functional capacity. The guidance force was initially set to 100% for all children, and then gradually reduced.
15876968|NCT03828110|Procedure|Physiotherapy|The physiotherapic sessions aimed at strengthening the gluteus and quadriceps muscles, stretching the hip flexor and hamstrings muscles, increasing static balance, increasing dynamic balance, increasing functional abilities, improving ground gait and climbing stairs.
15876969|NCT03828097|Dietary Supplement|Experimental supplement|Subjects in both arms will consume two pills daily. Prior to and following 12 weeks of supplementation, participants will arrive to the laboratory following an overnight fast in order to donate blood as well as fill out EuroQoL and POMS questionnaires.
15876970|NCT03828097|Dietary Supplement|Placebo|Subjects in both arms will consume two pills daily. Prior to and following 12 weeks of supplementation, participants will arrive to the laboratory following an overnight fast in order to donate blood as well as fill out EuroQoL and POMS questionnaires.
15876971|NCT03828084|Drug|Decitabine|Combination drugs containing decitabine and tetrahydrouridine
15876972|NCT03828071|Procedure|Autologous hematopoietic stem cell transplantation|"Stem cell mobilization and collection: Peripheral blood stem cells were mobilized with cyclophosphamide (2.0 g/m2) for 2 days and granulocyte colony-stimulating factor (G-CSF) at 5-10 μg/kg per day was administered when the level of peripheral leucocytes was < 1×109/L. Peripheral leukocyte counts were monitored, and harvesting was performed when the peripheral white blood cell level rebounded .
~Conditioning and reinfusion of stem cells: The conditioning regimen consisted of intravenous cyclophosphamide (40 mg/kg/day × 4 days) 5 days before transplantation (a total dose 160 mg/kg) and rabbit antithymocyte globulin (ATG) (2.5mg/kg/day × 3 days) 4 days before transplantation. The dose of cyclophosphamide and ATG could be reduced according to the patients' condition."
15876973|NCT03828058|Drug|Envarsus XR|Envarsus XR to be administered orally, once a day. Dosage will be adjusted as determined by trough blood levels.
15876974|NCT03828058|Drug|Prograf|Prograf 2 mg BID to be administered orally, twice a day. Dosage will be adjusted as determined by trough blood levels.
15876975|NCT03828045|Drug|Apremilast|Apremilast
15876976|NCT03828032|Procedure|Mannitol injection|Standard mannitol injection to decrease intracranial pressure of patients
15876977|NCT03828032|Procedure|Hypertonic saline injection|Standard Hypertonic saline injection to decrease intracranial pressure of patients
15876978|NCT03828019|Biological|Adalimumab (ADA)|Adalimumab is a fully-human monoclonal antibody to TNF-α, which is approved by the U.S. FDA for the treatment of non-infectious intermediate, posterior, and panuveitides in adults and children 2 years of age and older.
15876979|NCT03828019|Drug|Conventional immunosuppression (CON)|The study ophthalmologist will select amongst the permissible drugs (methotrexate, mycophenolate mofetil or azathioprine for antimetabolites; cyclosporine or tacrolimus for calcineurin inhibitors) taking into account the side effect profile of each drug with respect to subject's clinical situation.
15876980|NCT03828006|Dietary Supplement|Red Rice Yeast|Participants will take one tablet per day of a dietary supplement based on red rice yeas for a period of six months
15876981|NCT03828006|Other|Placebo Group|Participants of this group will take one tablet of placebo per day for a period of six months
15876982|NCT03827993|Behavioral|dedicated sexual health clinic appointment|Intervention will consist of a dedicated sexual health clinic appointment with a physician provider focused on sexual health in this population. This provider will perform a focused history and physical, and will then determine need for appropriate treatment and management, which may consist of recommendations for medications, psychosocial counseling, physical therapy, and/or dilator use, but are not required.
15876983|NCT03827980|Other|no intervention, only clinical examination|standardised interview and clinical examination
15876984|NCT03827967|Biological|PalloV-CC|The PalloV-CC vaccine uses yeast cell wall particles (YCWP) to serve as an efficient vaccine delivery system as they can contain a broad range of antigenic material, they are rapidly phagocytized by antigen presenting cells, and they are inherently immunogenic. The PalloV-CC vaccine utilizes silicate-capped YCWP to deliver allogenic colon cancer tumor lysate. The vaccine will be given to subjects with resectable colon cancers neoadjuvantly shortly before surgery in order to study the effect of the vaccine on the tumor microenvironment using a well-validated immune scoring system for colon cancer and other immunologic tests.
15876985|NCT03827954|Other|HeartMapp+CT|HeartMapp+CT is a mobile system that includes physiological modules that support self-monitoring and exercises that promote heart health, and computerized plasticity-based adaptive cognitive training modules that train participants to enhance cognitive functions and ultimately heart failure outcomes.
15876986|NCT03827941|Other|1 Hz Auricular transcutaneous electrical nerve stimulation|High-functioning individuals with autism randomized to this group will receive 1 Hz tVNS stimulation for 30 minutes/day up to 5 times/week for 3 weeks.
15876989|NCT03827915|Device|Double sequential external defibrillation|DSED is the process of using two defibrillators near simultaneously at their highest allowed energy setting and aims to treat refractory atrial fibrillation. The first set of pads is placed in the traditional anterolateral position and the second set can be either placed adjacent to the first set (antero-lateral) or in the antero-posterior position. Shocks are then delivered simultaneously or near simultaneously
15876990|NCT03827902|Device|Telcare 2.0 BGM|Blood glucose meter that uploads blood glucose measurements to a cloud server that providers can access and use to monitor patients' glycemic trends.
15876991|NCT03827889|Procedure|WMP of fluoride varnish|Application of fluoride varnish (drug of the intervention - Duraphat, Colgate) on all teeth, regardless of the lesions found
15876992|NCT03827889|Procedure|TWLP of fluoride varnish|application of the fluoride varnish (drug of the intervention - Duraphat, Colgate) only on the teeth with active initial caries lesions detected through visual examination after prophylaxis
15876993|NCT03827889|Behavioral|DHP (educational intervention)|The control group will receive diet and hygiene guidance (educational intervention) through verbal explanations and teeth brushing practices
15876994|NCT03827876|Drug|Enstilar 0.005%-0.064% Topical Foam|Enstilar 0.005%-0.064% Topical Foam applied once daily for 4 weeks followed by QOD for 12 weeks for patients receiving Enbrel or Humira
15876995|NCT03827863|Device|TTE|TTE to detect the heart function
15876996|NCT03827850|Drug|ERDAFITINIB|Daily in a range from 3 mg to 9 mg
15876997|NCT03827837|Biological|SHR-1210|SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
15876998|NCT03827837|Drug|Famitinib|a small-molecule multikinase inhibitor
15876999|NCT03827824|Device|Hysteroscopy & virtual reality glasses|Hysteroscopy. Virtual reality glasses. VAS. STAI scale.
15877000|NCT03827824|Device|Hysteroscopy|Hysteroscopy. VAS. STAI scale.
15877005|NCT03827785|Device|rTMS treatment group|For rTMS treatment, we will stimulate the dorsal lateral prefrontal cortex of each patients using the iTBS pattern everyday. Treatment will lasted for 30 days.
15877006|NCT03827785|Device|sham rTMS treatment group|For sham rTMS treatment, we will stimulate the dorsal lateral prefrontal cortex of each patients using the sham iTBS pattern and sham coil everyday for 30 minutes. Treatment will lasted for 30 days.
15877007|NCT03827772|Other|Fecal Microbiota Transplantation|30 grams of stool homogenized with 100 mL of normal saline administered a single time via nasojejunal tube.
15877008|NCT03827772|Other|Standard of care treatment|Nutritional supplementation, supportive management.
15877009|NCT03827746|Other|Tampa Kinesiophobia Scale, Berg-Balance Test, International Physical Activity Questionnaire-Short Form, Falls Efficacy Scale|"Tampa Kinesiophobia Scale: The TSK is a 17-item self report checklist using a 4-point Likert scale that was developed as a measure of fear of movement or (re)injury.
~Berg-Balance Test: 14-item scale designed to measure balance of the older adult in a clinical setting.
~International Physical Activity Questionnaire-Short Form: This measure assesses the types of intensity of physical activity and sitting time that people do as part of their daily lives are considered to estimate total physical activity in MET-min/week and time spent sitting.
~Falls Efficacy Scale: A 16- item self-administered questionnaire designed to assess fear of falling in mainly older population"
15877010|NCT03827720|Device|SENSE Device|Non-invasive radiofrequency (RF) sensor
15877011|NCT03827707|Behavioral|Noise|Noise applied via headphones during 60 min after meal ingestion
15877012|NCT03827707|Behavioral|Silence|Headphones without sound applied during 60 min after meal ingestion
15877013|NCT03827694|Diagnostic Test|Non-Invasive Testing for PIMI|galactomannan assay, fungal PCRs, cell-free next-generation DNA/RNA sequencing, RNAseq
15877014|NCT03827681|Procedure|Trans Intrahepatic Portosystemic Shunt|"The most common approach is through the right internal jugular approach.
~After infiltrating the puncture site with 2% lignocaine and puncturing the vein a guide wire is advanced into the IVC followed by a 9F/10F vascular sheath.
~A wedged venogram is performed with a peripherally placed hepatic vein catheter, which may identify a portion of the portal vein to facilitate subsequent puncture.'
~A stiff guide wire is then passed through the catheter and the vascular sheath is advanced into the right hepatic vein. With the vascular sheath in place a rigid needle with 15-20 degrees of distal angulation is advanced over the guide wire and through the vascular sheath to enter the hepatic vein."
15877015|NCT03827681|Procedure|Self Expanding Metallic Stent|"At upper endoscopy, a 0.35 Superstiff radiological guidewire with a soft tip (supplied with the stent insertion kit) is delivered into the stomach under direct vision and the endoscope is removed.
~The stent delivery device is then advanced over the guidewire into the stomach, and the distal portion of the stent delivery system is withdrawn to allow inflation of the gastric balloon.
~The gastric balloon is then inflated with 100 mL of air, and the whole delivery system is withdrawn until resistance is felt, which signifies that the balloon is impacting at the cardia, thus anchoring the distal end of the stent during deployment.
~After stent deployment, the gastric balloon is deflated and the stent delivery system is withdrawn. The stent is then examined endoscopically. When deployed, the stent is 135 mm long and 25 mm wide."
15877016|NCT03827681|Drug|Vasoactive Agent|Vasoactive Agent
15877017|NCT03827668|Drug|PF-06650833 alone|In Period 1, Days 1-5, participants will receive PF-06650833 once daily alone.
15877018|NCT03827668|Drug|PF-06651600 alone|In Period 2, Days 1-7, participants will receive PF-06651600 once daily alone.
15877019|NCT03827668|Drug|PF-06650833 together with PF-06651600|In Period 2, Days 8-12, participants will receive PF-06650833 once daily together with PF-06650833 once daily.
15877020|NCT03827655|Drug|TAK-954 Placebo|TAK-954 placebo-matching intravenous infusion.
15877021|NCT03827655|Drug|TAK-954|TAK-954 intravenous infusion.
15877022|NCT03827642|Drug|Treatment A: Naloxone Nasal Spray|Participants received naloxone nasal spray following a 10 hour fast.
15877023|NCT03827642|Drug|Treatment B: Naloxone Nasal Spray|Participants received naloxone nasal spray following a 10 hour fast.
15877024|NCT03827642|Drug|Treatment C: Naloxone HCl Intravenous (IV) Injection|Participants received naloxone HCl IV injection following a 10 hour fast.
15877025|NCT03827642|Drug|Treatment D: Naloxone HCl Intramuscular (IM) Injection|Participants received naloxone HCl IM injection following a 10 hour fast.
15877026|NCT03827629|Drug|Treatment A: Naloxone Nasal Spray|Participants received naloxone nasal spray following a 10 hour fast.
15877027|NCT03827629|Drug|Treatment B: Naloxone Nasal Spray|Participants received naloxone nasal spray following a 10 hour fast.
15877028|NCT03827629|Drug|Treatment C: Naloxone HCL Intramuscular (IM) Injection|Participants received naloxone HCl IM injection following a 10 hour fast.
15877029|NCT03827616|Radiation|Hypofractionated IMRT using helical Tomotherapy.|70 Gy in 28 fractions intensity-modulated radiotherapy (IMRT)
15877030|NCT03827616|Radiation|Hypofractionated IMRT using helical Tomotherapy.|60 Gy in 20 fractions intensity-modulated radiotherapy (IMRT) using helical Tomotherapy.
15877031|NCT03827603|Drug|Ibrutinib|Ibrutinib and rituximab combination for the treatment of steroid refractory AIC (warm type AIHA and PRCA) with underlying CLL.
15877032|NCT03827590|Drug|Test|three times a day for five days
15877033|NCT03827590|Drug|Active Comparator Control 1|three times a day for five days
15877034|NCT03827590|Drug|Active Comparator Control 2|three times a day for five days
15877035|NCT03827590|Drug|Placebo|three times a day for five days
15877036|NCT03827577|Procedure|Surgical removal of primary and/or of all oligometastases|Standard lobectomy or segmentectomy if tumor resectable without pneumonectomy (prefer lobectomy if cardiorespiratory function is not or only moderately compromised, prefer segmentectomy if primary tumor less than 2 cm or cardiorespiratory function is more than moderately compromised but still permissive) Mediastinal lymph node dissection (at least 8 lymphnodes from at least 3 stations including station 7).
15877037|NCT03827577|Radiation|Non-surgical LAT|Non-surgical LAT may be carried out either by SABR or SBRT or RFA according to site of metastasis, local expertise and availability of resources.
15877038|NCT03827577|Drug|Standard medical therapy|platinum-based doublet according to local protocols or targeted agents according to EGFR/ALK/ROS-1 mutational status or immunotherapy agents according to PDL1 expression.
15877039|NCT03827564|Device|Intranasal Tear Neurostimulator (ITN) [TrueTear®]|The ITN applies a small electrical current to the nasal cavities to gently activate the body's natural tear production system.
15877040|NCT03827551|Behavioral|Delivery of oral hygiene advices|Patients will benefit from hygiene advice and maintenance of good oral health. No treatment will be administered as part of this study. Patients will continue their usual treatment according to the contraindications. Patients will benefit from salivary sampling and a collection of oral bacteria contained in the dental plaque using paper tips. These reviews will be conducted during the Inclusion Visit and the 6 month Follow-Up Visit.
15877041|NCT03827525|Behavioral|Cognitive and Behavioral Therapy|9 sessions of Cognitive and Behavioral Therapy will be realised with the patient by a clinical psychologist. They will last between 1h and 1h30.
15877042|NCT03827512|Other|Doppler arterial waveforms analysis|terminology used when describing arterial Doppler waveforms
15877043|NCT03827499|Dietary Supplement|HMB dietary supplementation|Intervention groups including HMB supplementation (Ex-HMB and NoEx-HMB) will receive a 3 g daily dose of free acid HMB in powder form dissolved freely into 250 mL of water during a 24-week intervention
15877044|NCT03827499|Other|Multicomponent physical exercise program|Intervention groups including exercise (Ex-HMB and Ex-Plac) will complete an individualized multicomponent training program, five days a week during 24 weeks.
15877045|NCT03827486|Other|Standard of care (exercise)|Exercise program according to the standard of care
15877046|NCT03827486|Other|Domicilary exercise program|Domicilary exercise program according to protocol (evidence based medicine)
15877047|NCT03827473|Drug|Abiraterone Acetate|Given PO
15877048|NCT03827473|Drug|Antiandrogen Therapy|Given per standard of care
15877049|NCT03827473|Drug|Docetaxel|Given IV
15877050|NCT03827473|Drug|Prednisone|Given PO
15877051|NCT03827473|Other|Quality-of-Life Assessment|Ancillary studies
15877052|NCT03827473|Other|Questionnaire Administration|Ancillary studies
15877053|NCT03827460|Behavioral|Abstinence from alcohol|Participants will undergo a laboratory alcohol infusion session that terminates 2 weeks of monitored abstinence from alcohol
15877054|NCT03827460|Behavioral|Usual drinking|Participants will undergo a laboratory alcohol infusion session during a period of usual drinking behavior
15877057|NCT03827434|Device|Continuous glucose Monitoring Devices and Clarity Software|Patients with DM2 at the intervention group will be managed by Continuous glucose Monitoring and Clarity software
15877058|NCT03827434|Other|Point of Care (POC) blood glucose|Testing Blood Glucose levels with Point of Care (POC) blood glucose
15877059|NCT03827408|Drug|Midazolam group (MDZ)|IV Ampules of Dormicum 15mg/ 3ml, Hoffman-La Rouche Ltd., Basel, Switzerland
15877060|NCT03827408|Drug|Dexmedetomidine group (DEX)|IV Ampules of Precedex 4mcg/ml, Hospira. Inc., Lake Forest,IL USA.
15877061|NCT03827408|Drug|Combination of Midazolam and Dexmedetomidine (MDZ/DEX)|Combination of Nebulized solution of 0.3 mg/kg Midazolam, and 3µg/kg Dexmedetomidine respectively.(
15877062|NCT03827395|Biological|HEV 239|Hepatitis E vaccine against HEV genotypes 1 and 4. The HEV 239 vaccine is a 26 kDa recombinant polypeptide corresponding to amino acid residues 368-606 of the capsid protein of a genotype 1 HEV strain. The vaccine is expressed in Escherichia coli (E. coli) and vaccine doses contain 30 µg of the purified antigen in 0.5 mL buffered saline adsorbed to 0.8 mg aluminium hydroxide.
15877063|NCT03827395|Other|Placebo|0.9% Sodium Chloride Injection, USP (Normal Saline) is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection (WFI). Each mL contains sodium chloride 9 mg and may contain HCl or NaOH for pH adjustment (pH 5.3 [4.5 - 7.0]).
15877064|NCT03827382|Behavioral|Lifestyle Intervention|Physical activity program: 3-5 aerobic training sessions (15-40 minutes each) per week, combined with 2 resistance training per week as well as motivational coaching via telephone Nutritional counseling
15877065|NCT03827369|Diagnostic Test|ICU patient|Our study is to measure the coefficient of variation of the HCV of the radial arterial pulse among ICU patients with multiple organ failures (MOF). Patients admitted to Taoyuan General Hospital were recorded during the 6 months study.
15877066|NCT03827356|Device|Inspiratory muscle trainer (IMT)|The device incorporate a unidirectional valve independent of flow to guarantee constant resistance and included a specific pressure setting (in cm H2O).
15877067|NCT03827317|Radiation|[18F]GE-226|[18F]GE-226 is a radiolabelled Affibody® tracer which binds to the HER2 receptor with high affinity at a different epitope than trastuzumab. The active molecule is a 61 amino acid peptide that is modified site-specifically with one fluorobenzaldehyde molecule at the C-terminal.
15877068|NCT03827304|Device|Virtual Reality Distraction from Burn Pain|Patients wore a VR headset while undergoing a burns dressing change
15877069|NCT03827291|Drug|Exparel|Bilateral administration on each side of 30 ml aliquot containing 10 ml of liposomal bupivacaine (133 mg) and 20 ml of 0.25% bupivacaine (50 mg) in the fascial plane between the QL and psoas major muscles.
15877070|NCT03827291|Other|Thoracic epidural analgesia|Historical cohort that received thoracic epidural analgesia
15877071|NCT03827278|Drug|Voriconazole|"6mg/kg bid, was given on the first day, followed by intravenous 4mg/kg bid for 6 days, followed by oral Valconazole 200mg bid for at least 6 months.
~Amphotericin B sequential itraconazole group (intravenous amphotericin, dose 0.7 - 1.0 mg / kg / d, 14 days, then changed oral itraconazole 200 mg bid for 10 weeks, after which 100 mg bid maintenance Until CD4+ T cells are greater than 100 cells/L for at least 6 months"
15877072|NCT03827265|Device|repetitive transcranial magnetic stimulation (rTMS)|A rTMS system is an electromagnetic device that non-invasively delivers a rapidly pulsed magnetic field to the cerebral cortex in order to activate neurons within a limited volume without inducing a seizure. The device is intended to be used to treat patients meeting clinical criteria for MDD as defined in the Diagnostic and Statistical Manual of Mental Illnesses, Fourth Edition (DSM-IV). This guidance is issued in conjunction with a Federal Register notice announcing the classification of rTMS systems for the treatment of MDD.
15877073|NCT03827239|Other|Activity/Moderate Exercise|3-hour sedentary period with 3 minute activity breaks of moderate exercise every 30 minutes
15877074|NCT03827213|Drug|Exparel|A shot of long acting local anesthetic for post operative pain management
15877075|NCT03827213|Device|Indwelling Catheter|ropivacaine, given through a catheter inserted between the shoulders
15877076|NCT03827200|Drug|Ambrisentan|Ambrisentan will be administered subcutaneously at the Hospital on the days of HVPG deterination and taken orally at home between visits.
15877077|NCT03827187|Other|Motor imagery based EEG-BCI|Information gathered in this study may be useful when considering diagnosis of prolonged disorder of consciousness and successful adoption of device could lead to assistive communication intervention with therapeutic benefits. Participants undergo quick assessment to test ability to engage in task, if successful this implies they are minimally conscious, have some awareness of self and memory intact to remember commands. During training participant undergoes multiple sessions whereby they are conducting two different imagined movements to move a sound across the azimuthal plane in a direction dictated by an auditory cue. Participant will receive auditory feedback on the position of the sound which acts as a reflection of how well the participant is engaged in the task in terms of performance and consistency across trials. The participant will move on to use the imagined movements to answer a series of biographical, situational, basic logic and numbers/letters questions.
15877078|NCT03827174|Other|Return To Work Coordination|External and internal coordination regarding sick leave. Establishment of a common return to work plan between employer och employee.
15877079|NCT03827174|Behavioral|Behaviour Change Ability Program|"Return to work coordination
~Education for employers and employees in pain neuroscience, validation and problem-solving.
~Patient-specific goal setting for return to work
~Exercise and behavioural skills training related to return to work"
15877080|NCT03827161|Dietary Supplement|Glucosamine|Given PO
15877081|NCT03827161|Other|Placebo|Given PO
15877082|NCT03827148|Other|Pharmaceutical Care|Pharmaceutical care is an individualized patient-centric health service delivered by pharmacists that incorporates, but is not limited to, disease education, therapy management, self-care and self-management of disease and therapy as well as motivational guidance.
15877083|NCT03827135|Other|Traditional physical therapy|"Cervical isometrics 10 repetitions×1 set, 4 days/week and targeted muscle strechings (trapezius, scalenes and sternocleidomastoid) 10 repetitions×1 set, 4 days/week.
~Total of 4 sessions were given each consisting of 40 mins."
15877084|NCT03827135|Other|Cyriax manipulation|"Experimental group was given cyriax manipulation protocol along with the cervical isometrics and muscle strechings.
~Traction with rotation was not given in cases of bilateral arm pain. cervical isometrics 10 repetitions×1 set, 4 days/week and targeted muscle strechings (trapezius, scalenes and sternocleidomastoid) 10 repetitions×1 set, 4 days/week.
~Total of 4 sessions were given each consisting of 40 mins."
15877085|NCT03827122|Drug|onabotulinumtoxinA|Experimental group we will use BTX-A administration group. All patients (Male/Female) with bruxism associated with chronic pain in masseter muscles bilaterally Patients will have treatment with 20 units of BOTOX, (Allergan Inc.) per side will be injected at three points into masseter muscle bilaterally.
15877086|NCT03827109|Behavioral|Group educational activities|Group educational topics include nutrition, stress, IBD and school, and disease management, and are taught by experts in each content area. s.
15877087|NCT03827109|Behavioral|IBD educational website|Website with age-appropriate educational information, including information from the group educational activities.
15877088|NCT03827109|Behavioral|Monthly check-in calls from program coordinator|Phone calls from coordinator to encourage youth to do something fun with a friend (comparison group) or mentor (Mentoring Program). During the COVID-19 pandemic, virtual activities are encouraged. For those in the Mentoring Program, the coordinator will also ask about the mentee's relationship with the mentor.
15877089|NCT03827109|Behavioral|Mentor|Mentees will be matched with a mentor for a year-long, 1:1 mentee-mentor relationship. Matching mentors and mentees is based on gender (same), age, geographical proximity, ethnicity, and interests. Mentors and mentees are expected to have weekly contact (e.g., text, phone), with in-person contact 1 - 2 times per month, one of which can be attending a group activity together. Due to the COVID-19 pandemic, a modification was approved so that all study activities can be conducted virtually, e.g., the in-person mentor-mentee monthly activity can be conducted via Skype, and group activities are live streamed
15877090|NCT03827109|Behavioral|Fun group activities|"Program participants vote on fun group activities to participate in for support and to learn self-management skills through experiential opportunities and modeling. These are live streamed during the COVID-19 pandemic."
15877091|NCT03827109|Behavioral|Parent support group|Parents participate in a social/support group facilitated by an Investigator while mentees and mentors are socializing during group events (virtually during the COVID-19 pandemic).
15877092|NCT03827096|Drug|Suspension of human autologous MSC 3P in 1.5 ml|During the posterolateral spine fusion operation, 1.5 ml of cell suspension was mixed with 5cc of beta-tricalcium phosphate foam and 3.5 ml of patient's blood, and inserted between the right transverse processes of the lumbar spine.
15877093|NCT03827083|Other|cerebral pulse oximetry|Cognitive Functions by Cerebral Pulse Oximetry After General Anesthesia and Spinal Anesthesia
15877094|NCT03827070|Drug|Afatinib|Used Afatinib particles of which had an average size of 22 μm and a volume concentration of small particles (<5 μm) - only 19%
15877095|NCT03827070|Drug|Talcum powder|Used Talcum powder particles of which had an average size of 24.5 μm and a volume concentration of small particles (<5 μm) - only 11%
15877096|NCT03827057|Behavioral|Reconsolidation of Traumatic Memories (RTM)|"RTM is a trauma-focused, but not cognitive behavioral, therapy: it involves brief exposure to the trauma memory, but does rely on conscious responses to correct the symptoms of PTSD. RTM was first used to treat phobias in the 1970s, and has more recently been refined to focus on reconsolidation to update long-term memories, reconfiguring the salience structure of the original memory, and incorporating those changes into the overall memory structure. Reconsolidation is a neural mechanism for updating long-term memory, inserting new information that contradicts an essential element of the memory, which makes it possible to change the emotional tone and salience of the memory. It is hypothesized that RTM can thereby achieve quicker, greater, and more durable responses than with traditional exposure therapies."
15877097|NCT03827057|Behavioral|Prolonged Exposure (PE)|PE is a trauma-focused cognitive behavioral therapy (TFCBT) that depends on exposure to the feared stimulus as a central effector of change, utilizing extinction, which theorizes that if a trigger that previously elicited a fear response is presented enough times without reinforcement, the response fades. Previous researchers have shown that extinction involves the creation of a new blocking memory which prevents expression of the original fear memory. While PE has more evidence to support its efficacy in PTSD than other approaches, and a majority achieve a clinical response (e.g., decrease in CAPS score of 10 or more), many do not achieve complete remission of symptoms, and the blocking memory may be fragile, so subsequent triggers may result in relapse.
15877098|NCT03827044|Drug|Avelumab|Avelumab is a fully human monoclonal antibody (MoAb) of the immunoglobulin G (IgG) 1 subtype which specifically binds to the PD-L1 cell surface ligand and blocks its interaction with the PD-1 cell surface receptor.
15877099|NCT03827031|Other|Mutlidisciplinary medication Review (MMR)|The clinical pharmacist performs medication reconciliation and pharmaceutical analysis. The physician performs a clinical examination and analysis of the medical record. Both participate in a collaborative interview. The hospital physician calls the community pharamcist to discuss proposed changes on the order and to establish a new prescription. At the end of the stay, the clinical pharmacist will conduct an exit interview with the patient. Three months after discharge, the patient's community pharmacist will be contacted to assess whether the changes proposed in the MMR were accepted
15877100|NCT03827031|Other|Mutlidisciplinary medication Review (MMR) with community pharmacist follow-up|"Multidisciplinary medication review (MMR) The clinical pharmacist performs medication reconciliation and pharmaceutical analysis. The physician performs a clinical examination and analysis of the medical record. Both participate in a collaborative interview. The hospital physician calls the community physician to discuss proposed changes on the order and to establish a new prescription. At the end of the stay, the clinical pharmacist will conduct an exit interview with the patient.
~Community follow-up A summary of the follow-up report stating the therapeutic modifications (called below multidisciplinary correspondence documents) will be sent to the community pharmacist and physician. Within 2 months of discharge, the pharmacist performs a follow-up of medication changes accepted and not accepted by the community physician.
~Three months after discharge, the patient's community pharmacist will be contacted to assess whether the changes proposed in the MMR were accepted."
15877101|NCT03827018|Combination Product|mavrilimumab|1 mL of 150 mg in a pre-filled syringe
15877102|NCT03827018|Combination Product|placebo|1 mL of placebo in a pre-filled syringe
15877103|NCT03827018|Drug|prednisone|Prednisone tablets for oral administration containing either 1 mg, 2.5 mg, 5 mg, 10 mg, 20 mg or 50 mg of prednisone United States Pharmacopeia (USP)
15877104|NCT03827005|Dietary Supplement|L-arginine|NOW Foods, Bloomingdale, IL
15877105|NCT03827005|Dietary Supplement|Placebo|InHealth Specialty Pharmacy, Fargo, ND
15877106|NCT03826992|Drug|Vyxeos|Vyxeos Dose: daunorubicin 44 mg/m2 and cytarabine 100 mg/m2 administered via intravenous infusion over 90 minutes on Days 1, 3, and 5.
15877107|NCT03826992|Drug|Venetoclax|"Venetoclax Dose:
~Dose Level 0 - 400 mg daily for 21 days
~Dose Level -1 - 400 mg daily for 14 days"
15877108|NCT03826979|Other|Pliates method treatment|The participants undergo to a physical therapy rehabilitation program through the Pilates Method for 2 months.
15877109|NCT03826966|Device|reSET|reSET is a mobile app created by Pear Therapeutics, Inc., which has previously been approved by the FDA.
15877110|NCT03826953|Other|Nurse Led Allergy Clinic|Project to investigate if it is feasible to establish a nurse-led primary care-based allergy clinic intervention in NHS Lothian, and to understand the acceptability and estimate the impact of this service on improving access and outcomes in patients with allergic conditions.WE will undertake a mixed-methods longitudinal evaluation of the community-based nurse-led allergy clinic.
15877111|NCT03826940|Drug|Lovastatin 60 MG|60 MG Lovastatin per day for 3 consecutive days
15877112|NCT03826940|Drug|Placebos|60 MG Placebo per day for 3 consecutive days
15877113|NCT03826927|Other|treatment with NOACs or VKAs|treatment with NOACs or VKAs initiated or continued for prevention of ischemic events
15877114|NCT03826914|Dietary Supplement|CardioFlex Q10|CardioFlex Q10 is a cardiovascular health supplement developed to increase collagen production, repair connective tissues, and help the body metabolize fats and protein. CardioFlex Q10 contains high amounts of lysine, proline and vitamin C, which the body requires to produce connective tissue (collagen). CardioFlex Q10 also includes additional supporting nutrients such as vitamin E, selenium, bio flavonoids, Coenzyme Q10 (Ubiqionol) and magnesium. The ingredients in CardioFlex Q10 help regulate the body's production of cholesterol, strengthen the arteries and heart, and reverse oxidation.
15877115|NCT03826914|Dietary Supplement|Placebo|Isocaloric maltodextrin placebo that looks and tastes identical to CardioFLex Q10
15877116|NCT03826901|Drug|delgocitinib|Cream for topical application
15877156|NCT03826550|Drug|Solaraze 3% Topical Gel|Twice daily for 60 days. Each patient is expected to receive 120 doses
15877117|NCT03826875|Drug|Fluoxetine|Patients who suffered aneurysmal subarachnoid hemorrhage will be prescribed fluoxetine and evaluated for the preventative treatment of depression and health-related quality-of-life
15877118|NCT03826875|Drug|Placebo|Patients who suffered aneurysmal subarachnoid hemorrhage will be prescribed placebo and evaluated for the preventative treatment of depression and health-related quality-of-life
15877119|NCT03826862|Radiation|CT three-dimensional reconstruction|All patients will receive CT three dimensional reconstruction before surgery
15877120|NCT03826849|Behavioral|Insomnia Coach|Insomnia Coach is a mobile application that provides psychoeducation and self-management tools for insomnia symptoms based on cognitive behavioral therapy for insomnia (CBT-I)
15877121|NCT03826836|Behavioral|Mindfulness-based stress reduction|Mindfulness-based stress reduction (MBSR) is a structured programme of 8 weekly sessions of 2-2,5 hours in groups of 8-16 participants organized at the hospital sites. Additionally, participants are encouraged to practice each day for 30-45 minutes using audio-recordings of the guided exercises. The programme is provided by experienced mindfulness teachers according to the standard MBSR protocol, except for the all-day session.
15877122|NCT03826823|Device|HSG cannula|a thin catheter originally designed for IUI was introduced through the cervical canal into the lower part of the uterine cavity. After introducing the catheter, the screw of the vaginal speculum was loosened to allow the two valves of the speculum to press on the portiovaginalis of the cervix to prevent leakage of the dye. Then the dye was injected slowly and the procedure was watched on the screen and x-ray films were taken.
15877123|NCT03826810|Radiation|aPDT|For the aPDT the PapacarieMblue (Fórmula e Ação) was used. It was left for 5 minutes in the cavity. The carious tissue was removed and the application of the PapacarieMblue was repeated. The tissue was then irradiated in a single spot with a red laser, of wavelength of 660 nm, for 300 s, with the energy of 500mJ. These parameters were also applied in the vestibular root of the teeth, to try and prevent sensitivity.
15877124|NCT03826810|Procedure|ART|Removal of infected dentin with a curette only, followed by cavity cleaning and restoration with glass ionomer cement.
15877125|NCT03826784|Combination Product|BHA|BHA active ingredients include a blood-derived component and beta-tricalcium phosphate. It is applied directly to the bone fracture and nearby viable bone at the time of wound closure.
15877126|NCT03826771|Behavioral|Power training|high-intensity lower extremity resistance training
15877127|NCT03826771|Behavioral|Stretching|upper and lower body range of motion exercises
15877128|NCT03826758|Other|E-DYNAMIC Clinical Decision Support|Clinical decision support system
15877129|NCT03826745|Other|Plasma/Urine|Plasma of normal male and female normotensive, hypertensive, and/or resistant hypertensive subjects.
15877130|NCT03826732|Behavioral|Guided self-help based on ACT|ACT-based self-help book and regular support by trained facilitators
15877131|NCT03826719|Biological|NBP607QIV|Purified inactivated influenza virus surface antigens of four strains(quadrivalent)
15877132|NCT03826719|Biological|Agrippal|Influenza virus surface antigens of three strains(trivalent)
15877133|NCT03826706|Device|C-MAC Videolaryngoscope D blade|C-MAC videolaryngoscope D blade An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with C-MAC videolaryngoscope.
15877134|NCT03826706|Device|McGrath MAC Videolaryngoscope X3 blade|McGrath MAC videolaryngoscope X blade An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with McGrath MAC videolaryngoscope.
15877135|NCT03826693|Drug|Nitrous Oxide|OCD participants in this arm will receive 50%oxygen/50% nitrous oxide admixture for 60 minutes.
15877136|NCT03826693|Drug|Nitrogen|OCD participants in this arm will receive 50%oxygen/50% nitrogen admixture for 60 minutes.
15877137|NCT03826680|Procedure|Flexible fiberoptic laryngoscopy|Patients who will undergo thyroidectomy will be evaluated by awake flexible fiberoptic laryngoscopy and during surgery by direct laryngoscopy under general anesthesia
15877138|NCT03826680|Procedure|Direct laryngoscopy|Patients who will undergo thyroidectomy evaluated before by ENT physician, will be evaluated by anesthesiologist in means of MCL score by direct laryngoscopy during surgery under general anesthesia
15877139|NCT03826667|Device|PEEK Suture Anchors|"Subjects who have received PEEK Suture Anchors in the shoulder:
~Healicoil PK Preloaded Suture Anchors, Bioraptor 2.3 PK Suture Anchors, Bioraptor Curved 2.3 PK Suture Anchors, Bioraptor Knotless Suture Anchors, Multifix S Ultra Knotless Fixation System, Footprint Ultra PK Suture Anchors, Twinfix Ultra PK Suture Anchors, SpeedScrew, SpeedLock"
15877140|NCT03826654|Dietary Supplement|fortified oil|35 g fortified sunflower oil
15877141|NCT03826654|Dietary Supplement|Placebo|plain oil
15877142|NCT03826641|Drug|HCP1805|Dapagliflozin/Metformin (Xigduo XR) 10/1000mg
15877143|NCT03826641|Drug|HCP1801|Dapagliflozin/Metformin 10/1000mg
15877144|NCT03826628|Drug|rapamycin|Apply to the affected area once a day, approximately half an hour before retiring for bed in the evening, for 26 weeks
15877145|NCT03826628|Drug|placebo|Apply to the affected area once a day, approximately half an hour before retiring for bed in the evening, for 26 weeks
15877146|NCT03826615|Drug|Gabapentin|Patients receive gabapentin 100mg orally for 3 times a day during the period of first and second cataract operations
15877147|NCT03826602|Drug|Tucatinib|150mg administered orally twice daily
15877148|NCT03826602|Drug|Metformin|850mg administered orally
15877149|NCT03826602|Drug|Iohexol|1500 mg administered intravenously (IV)
15877150|NCT03826589|Drug|Avelumab|an anti-programmed cell death ligand 1
15877151|NCT03826589|Drug|Axitinib|a tyrosine kinase inhibitor that also inhibits VEGF receptor 1-3, c-KIT and PDGFR
15877152|NCT03826576|Behavioral|Multicomponent intervention|"The multicomponent intervention will be consist of:
~Training of the restaurant staff (waiters and cookers) about Mediterranean and Healthy Diet and food allergens,
~Nutritional and food allergen analysis of the menu of the restaurant
~Improvement of the menu to follow the Mediterranian diet standards (AMED criteria), the nutritional quality of the menu and the adaptations of the menu for food allergies and food intolerances
~Marketing campaign about healthy and food allergen adapted menus in the restaurants"
15877153|NCT03826563|Drug|oral melatonin tablets (NatureMade brand)|melatonin tablets
15877154|NCT03826563|Other|Placebo|pill placebo
15877155|NCT03826550|Drug|Diclofenac Sodium Gel|Twice daily for 60 days. Each patient is expected to receive 120 doses
15877158|NCT03826537|Other|Honey substance|Honey substance containing 5.1 mg/kg tutin and 23 mg/kg hyenanchin
15877159|NCT03826524|Drug|Epinephrine|Epinephrine 1mg 1:10000 (10cc) per dose
15877160|NCT03826511|Other|Tiszasüly hot mud-pack therapy|Patients received Tiszasüly hot mud-packs (42 Celsius degree) for 30 minutes on 10 occasions for 2 weeks (10 working days) on the painful knee.
15877161|NCT03826511|Other|Kolop mud-pack|Patients received Kolop hot mud-packs (42 Celsius degree) for 30 minutes on 10 occasions for 2 weeks (10 working days) on the painful knee.
15877162|NCT03826498|Biological|CP CB-MNC injection|CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.
15877163|NCT03826498|Other|Standard therapy|The standard therapy can include drugs, special psychology training etc.
15877164|NCT03826485|Drug|PRIC|Pranlukast hydrate 50mg
15877165|NCT03826485|Drug|Pranlukast hydrate|Pranlukast hydrate 225mg/2.25g
15877166|NCT03826472|Other|Almond Butter|Natural almond butter
15877167|NCT03826459|Procedure|Non-Locking Uterine Closure|The first layer of the two-layer uterine closure will be sutured with a running & non-locking technique. The second layer cannot be of a locking technique.
15877168|NCT03826459|Procedure|Locked Uterine Closure|The first layer of the two-layer uterine closure will be sutured with a running & locking technique. The second layer can be locking or non-locking.
15877169|NCT03826446|Procedure|Surgery|laparoscopic and open complete mesocolic excision with central vascular ligation in right colon cancer.
15877170|NCT03826433|Biological|Peripheral iv|6*10^7 cells
15877171|NCT03826420|Behavioral|SCF Supervision with Secure Confinement Sanctioning|Parolees assigned to this group will, in the face of a violation, be given a sanction that involves secure confinement.
15877172|NCT03826420|Behavioral|SCF Supervision with Work Release Sanctioning|Parolees assigned to this group will, in the face of a violation, be given a sanction that involves work-release.
15877173|NCT03826420|Behavioral|SCF Supervision with GPS Supervision Sanctioning|Parolees assigned to this group will, in the face of a violation, be given a sanction that involves GPS supervision.
15877174|NCT03826394|Behavioral|Exercise Intervention|Education based sixteen week intervention where participants will be provided with core information every three weeks and supplementary information through technological means at other time points. All provided information will be exercise specific. Individualised and group support provided throughout the first twelve weeks and withdrawn for the final four weeks. Fitbit Flex 2 provided for the duration of the study.
15877175|NCT03826394|Behavioral|Dietary Intervention|Education based sixteen week intervention where participants will be provided with core information every three weeks and supplementary information through technological means at other time points. All provided information will be diet specific. Individualised and group support provided throughout the first twelve weeks and withdrawn for the final four weeks. Fitbit Flex 2 provided for the duration of the study.
15877176|NCT03826381|Diagnostic Test|Magnetic resonance (MR) spectroscopy of the liver|Magnetic resonance (MR) spectroscopy of the liver. Golden standard for non-invasive determination of NAFLD
15877177|NCT03826381|Diagnostic Test|Fibroscan|Transient Elastography for Measurement of liver fibrosis.
15877178|NCT03826381|Device|Continuous glucose monitoring (CGM) for four days.|CGM is attached to the abdominal skin for four days. Afterwards data is converted and analysed in a computer program.
15877179|NCT03826381|Radiation|Dual Energy X-ray Absorptiometry (DEXA) scan|DEXA-scan of the body composition.
15877180|NCT03826381|Biological|Blood samples|Immediately analyse of basic lab data. Later analyses for glucagon, amino acids, bile acids, lipidomics and metabolomics.
15877181|NCT03826381|Other|Clinical and demographic data|Measurements of blood pressure, pulse, height, weight.
15877182|NCT03826368|Dietary Supplement|Hemp-derived botanical dietary supplement|Subjects currently taking phytocannabinoid Hemp-derived botanical dietary supplements during recovery from brain injury.
15877183|NCT03826355|Procedure|CO2 (carbon dioxide) laser vaporisation|CO2 (carbon dioxide) laser is used to vaporise the inner wall of the endometrioma
15877184|NCT03826355|Procedure|Stripping technique|Identification of a cleavage plane and perform the cystectomy removing all the wall of the endometrioma from the healthy ovarian tissue
15877185|NCT03826342|Behavioral|Health Check-up for Expectant Moms|A brief intervention (one session plus two booster sessions)
15877186|NCT03826342|Behavioral|Time, attention, and information-matched control|We will include facts about alcohol/drug use and risky sex during pregnancy, along with informational brochures that provide face validity.
15877187|NCT03826329|Other|observational study|this is an observational study, there is no intervention in this study
15877188|NCT03826316|Drug|Nalbuphine|Pharmacokinetic study under fasting conditions
15877189|NCT03826303|Other|E-cigarette liquid with ethanol, 1 puff|E-cigarette liquid with ethanol, 1 puff
15877190|NCT03826303|Other|E-cigarette liquid without ethanol, 1 puff|E-cigarette liquid without ethanol, 1 puff
15877191|NCT03826303|Other|E-cigarette liquid with ethanol, 10 puffs|E-cigarette liquid with ethanol, 10 puffs
15877192|NCT03826303|Other|E-cigarette liquid without ethanol, 10 puffs|E-cigarette liquid without ethanol, 10 puffs
15877193|NCT03826290|Other|EHR-integrated diabetes dashboard|The diabetes dashboard is available as a tab in the electronic health record (EHR) system and enables clinicians to confirm relevant patient parameters, select treatment goals, and review likely outcomes from alternative treatment strategies through an interactive graphical user interface.
15877194|NCT03826277|Other|Melanostop peel|"Melanostop peel treatments containing 20% azelaic acid, 10% resorcinol, 6% phytic acid, 3% tranexamic acid. (4 treatments, performed at 2-week intervals), in combination with home care products (twice daily):
~a facial tonic and cream containing brightening ingredients: vitamin C, niacinamide, alpha arbutin, kojic acid,
~sunscreen protection cream with SPF 50, protecting against UVA, UVB, HEV and IR"
15877195|NCT03826264|Procedure|TAVR|transcatheter aortic valve replacement (TAVR)
15877196|NCT03826251|Procedure|Nasogastric tube removal|Nasogastric tube was removed immediately after surgery
15877223|NCT03826004|Drug|Saline Solution|Saline solution 2ml intramuscular injection is administrated into the gluteus maximus muscle
15877251|NCT03825783|Biological|RP-L201|CD34+ enriched hematopoietic stem cells from subjects with severe LAD-I transduced ex vivo with lentiviral vector carrying the ITGB2 gene, Chim-CD18-WPRE.
15877197|NCT03826238|Diagnostic Test|Validation Gate task|"The task is to observe several moving unfilled white circles on a dark background. The circles move in straight paths. Every so often, a randomly selected circle will displace to a point inconsistent with its trajectory, which will look like a jump. The subjects' task is to press the space bar every time they detect a displacement (e.g. jump). A session consists of 30 minutes, it starts with 2 training blocks which are followed by 2 no-cognitive load blocks and 6 blocks with increasing cognitive load conditions. During the assessment the eye movement as well as the key presses are registered in order to calculate early and late saccades as well as conscious reporting. Resting-state EEG will also be recorded and compared to the ones of age-matched healthy controls. Task-dependent EEG data will be recorded during the Validation Gate task."
15877198|NCT03826212|Dietary Supplement|Soybean Germ Extract|Soybean Germ Extract 1,600 mg/day for 12 weeks.
15877199|NCT03826212|Dietary Supplement|Placebo|Placebo 1,600 mg/day for 12 weeks.
15877200|NCT03826199|Drug|TDF-FTC|We will investigate the feasibility and acceptability of integrating PrEP into antenatal and postnatal/well-baby services. Upon enrollment in the cascade, all women will be offered PrEP counseling and information, and patients will be followed regardless of their choice to initiate PrEP or not. Participants who initiate PrEP will receive TDF-FTC during the study. At each study visit (every 3-months), women will receive counseling on PrEP adherence or on the risks and benefits of PrEP for women not yet initiated. We will evaluate PrEP initiation and adherence in pregnant and breastfeeding women (N=220) from first antenatal care visit through 12 months post-partum.
15877201|NCT03826199|Behavioral|Counselling on PrEP in antenatal and postnatal care|Information about PrEP will be integrated into regular group education in ANC by existing health care providers during discussion about HIV testing and treatment. During every study visit, PrEP counseling (including adherence counseling for women already on PrEP) will be provided. For women not on PrEP, counselling will be provided on PrEP and HIV prevention.
15877202|NCT03826186|Device|Traditional (loss-of-resistance technique) thoracic epidural placement|Thoracic epidurals will be administered using the traditional loss-of resistance technique.
15877203|NCT03826186|Device|CompuFlo thoracic epidural placement|Pressure sensing technology to consistently and accurately identify the thoracic epidural space.
15877204|NCT03826173|Behavioral|PPPA|The intervention will focus on a) health benefits of PA, b) individualized PA intensity prescriptions and instruction on gauging PA intensity, c) goal-setting and self-monitoring, and d) tips on overcoming barriers to PA. Participants will be instructed to target 30-60 min/day 5 days/week of MVPA consistent with national guidelines. PA content will be concentrated in sessions 1 and 2, but content on goal-setting, self-monitoring, and overcoming barriers will continue throughout the 6-week period. The intervention includes activities that focus on identifying each individual's strengths, identifying/savoring positive experiences, engaging in constructive conversation, expressing gratitude, and strategies to maintain increased positive affect after the intervention has completed.
15877205|NCT03826173|Behavioral|PA|The intervention will focus on (a) health benefits of PA, (b) individualized PA intensity prescriptions and instruction on how to gauge PA intensity, (c) goal-setting and self-monitoring, and (d) tips on overcoming barriers to PA, including time-management. Participants will be instructed to target 30-60 min/day 5 days/week of MVPA consistent with national guidelines. PA content will be concentrated in sessions 1 and 2, but content on goal-setting, self-monitoring, and overcoming barriers will continue throughout the 6-week period.
15877206|NCT03826147|Dietary Supplement|Nitrate-rich beetroot juice|Daily supplementation with ~100 kcal of nitrate-rich beetroot juice containing 400 mg of dietary nitrate (James White Drinks, UK).
15877207|NCT03826147|Dietary Supplement|Nitrate-depleted beetroot juice|Daily supplementation with ~100 kcal of nitrate-depleted beetroot juice (James White Drinks, UK).
15877208|NCT03826134|Drug|[11C]PXT012253|Single intravenous bolus injection. The injected amount will be less than 5 μg. The radioactive dose is approximately 400 MBq per 70 kg body weight.
15877209|NCT03826121|Dietary Supplement|Sesame Oil Cake Extract|Sesame Oil Cake Extract 1.5 g/day for 12 weeks.
15877210|NCT03826121|Dietary Supplement|placebo|placebo for 12 weeks.
15877211|NCT03826069|Other|Augmented reality-based curriculum|Participants in the Augmented Reality Group will be taught principles in augmented reality and training sessions will be enhanced by an augmented reality platform. This involves training on virtual reality simulators with superimposed videos and guides demonstrating correct procedure. In this study, the videos and guides will be on identifying and removing polyps.
15877212|NCT03826069|Other|Conventional Simulation Curriculum|Participants in this group will will train from low- to high-fidelity colonoscopy simulation. During training, the participants will receive guidance and feedback from expert endoscopists. In addition, there will be didactic sessions covering theory of colonoscopy.
15877213|NCT03826056|Behavioral|Current standard discharge educational intervention|The patients will receive the current hospital standard discharge educational material which explains the diagnosis, new medications, follow up and any activity/diet restrictions. A member of the study team will explain this material to the patient and answer any questions.
15877214|NCT03826056|Behavioral|Personalized discharge educational intervention|The patients will receive a new personalized discharge educational material which will explain the specifics of their disorder, the treatment, and prognosis. The materials will contain simple, organized explanations and graphics. A member of the study team will explain this material to the patient and answer any questions.
15877215|NCT03826043|Diagnostic Test|Blood sample analysis|Thrombophilia, blood count and coagulation count
15877216|NCT03826030|Device|Sham|sham group receives no active current stimulation except 15 seconds of current ramp up in the beginning and 15 seconds of current ramp up in the end of the 30-minute session to create a scalp perception to blind the subject.
15877217|NCT03826030|Device|Low dose tDCS|The low dose tDCS group receives direct current stimulation at 2 mA for 30 minutes per session
15877218|NCT03826030|Device|High dose tDCS|The high dose tDCS group receives direct current stimulation at 4 mA for 30 minutes per session
15877219|NCT03826030|Behavioral|mCIMT|All three tDCS groups receive constraint-induced movement therapy as the adjunctive behavioral therapy for 2 hours per session
15877220|NCT03826017|Dietary Supplement|Catechin high contain greentea extract|Catechin high contain greentea extract 260 mg/day for 12 weeks.
15877221|NCT03826017|Dietary Supplement|Placebo|Placebo for 12 weeks.
15877222|NCT03826004|Drug|Clemastine|Clemastine fumarate 2mg/2ml intramuscular injection is administrated into the gluteus maximus muscle
15877224|NCT03825978|Behavioral|Prenatal Genetic Counseling|In this study prenatal genetic screening counseling was provided from the begining of the pregnancy, different from the other studies in the literature. In the literature, most of the study evaluated pregnant women's anxiety, information status about the test and decisional conflicts, only prenatal screening process or prenatal diagnosis process. In this study pregnant women were evaluated both in prenatal screening test and prenatal diagnosis procedures.
15877225|NCT03825965|Drug|Cannabidiol (CBD)|Oral cannabidiol capsules
15877226|NCT03825965|Drug|Placebo oral capsule|Visually identical placebo oral capsule (medium chain triglyceride oil)
15877227|NCT03825952|Device|MERM - medication event reminder monitor|The MERM will help measure adherence to ART in routine clinical care.
15877228|NCT03825939|Drug|Intravenous Placebo|IV 0.9% sterile saline
15877229|NCT03825939|Drug|Intravenous Tranexamic Acid|1g TXA IVPB (intravenous piggyback)
15877230|NCT03825913|Behavioral|Exercise Intervention|"Training sessions will include a split routine based on the day of the week.
~Session 1 (e.g. Tuesday) - aerobic exercise (20-30 min) followed by resistance training (10 stacked-weight machines: leg press, leg extension, leg curl, chest press, latissimus pull, shoulder press, seated row, triceps press, biceps curl, and chest fly) for 1-2 sets of 8-12 repetitions.
~Session 2 (e.g. Thursday) - resistance bands and body weight exercises (4-6 exercises, 2 sets of 10-20 repetitions) followed by core exercises (2-3 sets of 10-20 repetitions) and aerobic training (20-30 min) at the end.
~The starting training intensities will be at 50-55% of each individual's estimated maximum heart rate for aerobic exercise and one-repetition maximum for resistance training (assessed at baseline only for chest press and leg press). We plan a 5% monthly increase in the intensity to reach 65-70%% of one's maximum efforts by the end of the intervention."
15877231|NCT03825913|Behavioral|Wellness Intervention|In our setting, ten lectures in nutrition, exercise and various complementary and integrative medicine topics (e.g. acupuncture and Chinese medicine, mindfulness, quality sleep, etc.) were implemented among non-cancer individuals and modified based on their feedback.
15877232|NCT03825900|Device|Sham OR active Transcranial direct current stimulation|Sham OR active transcranial direct current stimulation over the motor cortex
15877233|NCT03825887|Drug|Nalbuphine|"Nalbuphine (Group B): Patients will be started on the same dose of 10 mcg / kg / hour as a background and 10mcg bolus dose with lock-out 20 minutes having the maximum allowed dose up to 40mcg /kg/ hour.
~Any patient will continue to complain of pain rating 4-6 on VAS after reaching the maximum designated dose (which is 40 mcg/kg/hour) will be transferred to the ICU for close monitoring according to the internal hospital guidelines and getting him/her out of the study.
~There is no drug shifting at any part of the study."
15877234|NCT03825887|Drug|Morphine|"morphine (Group A): Patients will be started on the same dose of 10 mcg / kg / hour as a background and 10mcg bolus dose with lock-out 20 minutes having the maximum allowed dose up to 40mcg /kg/ hour.
~Any patient will continue to complain of pain rating 4-6 on VAS after reaching the maximum designated dose (which is 40 mcg/kg/hour) will be transferred to the ICU for close monitoring according to the internal hospital guidelines and getting him/her out of the study.
~There is no drug shifting at any part of the study."
15877235|NCT03825874|Other|Amikacin|A first anorectal swab will be performed before starting any antibiotic treatment Three to four days after the start of antibiotic treatment, patients will be seen again and a new anorectal swab will be performed.
15877236|NCT03825874|Other|usual antibiotic treatment|A first anorectal swab will be performed before starting any antibiotic treatment Three to four days after the start of antibiotic treatment, patients will be seen again and a new anorectal swab will be performed.
15877237|NCT03825861|Drug|FOLFIRINOX|Oxaliplatin 85mg/m2, Leucovorin 200mg/m2, Irinotecan 180mg/m2, 5-FU 400mg/m2 bolus followed by 2400mg/m2 continuous infusion.
15877238|NCT03825848|Procedure|trans jugular intrahepatic portal systemic shunt|Shunting left or right PV branch in the TIPS procedure
15877239|NCT03825835|Drug|30% oxygen group|"Infants in the 30% oxygen group will remain in 30% oxygen (O2) until 5 min of age. At 5 min of age, the clinical team will assess oxygen saturation (SpO2). If SpO2 is <85%, O2 should be increased by 10-20% every 60 sec to achieve SpO2 of 85% or greater or a SpO2 of 90-95% at 10 min of age. If SpO2 are greater than 95% at or before 5 min of age, O2 should be decreased stepwise (every 60 sec) with an aim to maintain SpO2 of 85% or greater during 5-10 min of age or 90-95% at and beyond 10 min of age.
~Intervention: Infants randomized to the 30% oxygen group will receive 30% oxygen at birth for the first 5 minutes. At 5 minutes oxygen can be adjusted as needed."
15877240|NCT03825835|Drug|60% oxygen group|"Infants in the 60% oxygen group will remain in 60% oxygen (O2) until 5 min of age. At 5 min of age, the clinical team will assess oxygen saturation (SpO2). If SpO2 is <85%, O2 should be increased by 10-20% every 60 sec to achieve SpO2 of 85% or greater or a SpO2 of 90-95% at 10 min of age. If SpO2 are greater than 95% at or before 5 min of age, O2 should be decreased stepwise (every 60 sec) with an aim to maintain SpO2 of 85% or greater during 5-10 min of age or 90-95% at and beyond 10 min of age.
~Intervention: Infants randomized to the 60% oxygen group will receive 60% oxygen at birth for the first 5 minutes. At 5 minutes oxygen can be adjusted as needed."
15877241|NCT03825822|Behavioral|ImPaC Resource Intervention (INT)|"A Change Team will lead the implementation process of the ImPaC Resource using the steps:
~Step 1: Complete a checklist to ensure its members can commit to responsibilities.
~Step 2: Reflect on the unit's readiness for change.
~Step 3: Perform an audit on 10 to 15 medical charts.
~Step 4: Identify a practice change based on audit results (pain assessment or pain treatment). Develop an aim statement for the practice change.
~Step 5: Select the KT strategies and plan the implementation.
~Step 6: Perform an audit on 10 to 15 medical charts.
~Step 7: Examine the effectiveness of the implementation and decide on the aim and KT strategies for the next cycle of change."
15877242|NCT03825822|Other|Standard Practice (SP)|The SP arm will continue as usual with their standard pain practices and will be offered the intervention 6 months after randomization and completion of data collection.
15877243|NCT03825809|Drug|Celecoxib|Post-Operative Non Opioid Pain Protocol
15877244|NCT03825809|Drug|Hydrocodone-Acetaminophen|Traditionally used narcotic pain protocol
15877245|NCT03825809|Drug|Ketorolac|Post-Operative Non Opioid Pain Protocol
15877246|NCT03825809|Drug|Gabapentin|Post-Operative Non Opioid Pain Protocol
15877247|NCT03825809|Drug|Acetaminophen|Post-Operative Non Opioid Pain Protocol
15877248|NCT03825809|Drug|Diazepam|Post-Operative Non Opioid Pain Protocol
15877252|NCT03825770|Behavioral|"The PEP (Personal Energy Planning) Program"|The PEP program is designed to teach people on dialysis with fatigue how to conserve energy during day-to-day tasks, and how to use energy conservation to accomplish their goals. The program is delivered over 7-9 weekly sessions. It consists of 2 educational web modules about energy conservation, and 5-7 goal-focused training sessions with a study clinician that utilize a problem-solving training approach known as the Cognitive Orientation to Occupational Performance (CO-OP) approach. Each program session lasts ~20-30 mins. Sessions are completed either in person during hemodialysis, or via telephone (based on patient preference). The program is administered by a trained study clinician (occupational therapist or nurse).
15877253|NCT03825770|Behavioral|General Education about Kidney Disease|"General education about kidney disease involves a review of information from the Kidney Foundation of Canada's patient handbooks Living with Reduced Kidney Function and Living with Kidney Failure (www.kidney.ca/manual) during 6-8 brief individual sessions with a trained study clinician (occupational therapist or nurse).The handbooks contains general information about managing kidney disease, addressing topics such as medication management, diet, and emotional well-being on dialysis. Sessions will take place either in person during hemodialysis, or via telephone (based on patient preference)."
15877254|NCT03825757|Drug|Placebo Oral Tablet|Placebo Oral Tablet
15877255|NCT03825757|Drug|Acetyl Salicylic Acid|Primaspan 250 mg tablet Acetyl Salicylic Acid
15877256|NCT03825744|Drug|Hetrombopag Olamine+Standard Therapy|once daily
15877257|NCT03825744|Drug|Placebo+Standard Therapy|once daily
15877258|NCT03825731|Biological|GC022|GC022 is a bispecific CAR-T cell immunotherapy that targeted CD19 and CD22. The subjects will receive one dose of GC022 infusion. The dosage ranges from 3×10^5 to 1×10^7 CAR+T/Kg.
15877259|NCT03825718|Biological|GC007F|GC007F is the CAR-T cell immunotherapy targeted CD19. The subjects will receive GC007F as one dose. The dosage ranges from 6×10^4 to 2×10^6 CAR+T/Kg.
15877260|NCT03825705|Drug|TQB2450 injection|TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.
15877261|NCT03825705|Drug|Anlotinib|A multi-target receptor tyrosine kinase inhibitor
15877262|NCT03825692|Drug|Zhizhu Kuanzhong Capsule|Zhizhu Kuanzhong Capsule, 3 capsules at a time, 3 times a day, taken orally 10-15 min before meals. an 8-week intervention period
15877263|NCT03825692|Drug|Zhizhu Kuanzhong Placebo Capsule|Placebo, 3 capsules at a time, 3 times a day, taken orally 10-15 min before meals. an 8-week intervention period
15877264|NCT03825666|Other|ProvideXtra® Fresenius Kabi|Improving wellbeeing
15877265|NCT03825640|Behavioral|CARE|Hybrid in-person and telephone-based adjunctive intervention for bipolar disorder across the transition from prison to the community.
15877266|NCT03825627|Device|Transcranial Direct Current Stimulation|"Conductive saline-soaked rubber electrodes super-imposed on sponge plates will be placed on the scalp at F3 (active electrode, 4.4×4.4cm) and on the contralateral supraorbital area (reference electrode, 5.1×10.2cm).
~Stimulation will be applied using a battery-driven constant-current regulator (Oasis Pro, Edmonton, Alberta, Canada). For each stimulation, the direct current is initially increased in a ramp-like fashion over 10 s until reaching 2 milliampere (mA) and will be similarly decreased at the end of stimulation.
~In the active tDCS condition, stimulation will be maintained for 20 min; in the sham condition, it will be turned off after 15 s of stimulation, with a ramp-up/down of 10 s (i.e., 35 s total)."
15877267|NCT03825614|Behavioral|training|plates and therapeutic exercises applied on young adults
15877268|NCT03825601|Diagnostic Test|PET with [11C]Flumazenil|7T MRI sequences : TSE, T2w FLAIR GRE-T2* and DIR 3T MRI sequences: T1, T2, T1 with gadolinium, magnetization transfer, diffusion weighted, resting state fMRI.
15877269|NCT03825588|Behavioral|ASAP (As Safe As Possible)|ASAP (As Safe As Possible) is a brief intervention for adolescents hospitalized for suicide risk that focuses on the development of a safety plan, teaching emotion regulation and distress tolerance skills, along with 1-2 post-discharge follow-up calls to encourage adherence to use of the safety plan and to outpatient treatment.
15877270|NCT03825588|Behavioral|BRITE smart phone app|BRITE is a smart phone app that aims to support daily emotion regulation and a safety plan that is personalized to the needs and preferences of each adolescent.
15877271|NCT03825588|Behavioral|TAU (treatment as usual)|TAU (treatment as usual) is the standard treatment that all adolescents admitted to their respective Inpatient Psychiatry Program receive.
15877272|NCT03825575|Device|Low level laser therapy (LLLT)|A 3 week treatment period with a total of 8 treatments of 1 hour over the sacral spinal cord
15877273|NCT03825562|Behavioral|acceptance and commitment therapy, ACT|
15877274|NCT03825549|Behavioral|Individual audit feedback|Practice sites randomly assigned to have individual audit feedback will be sent information by email to each clinician at the site each month for the duration of the intervention period. The email will inform the clinician that the health system is doing monthly audits and provide them the number of patients in the last month for whom they prescribed 30 opioid pills per prescription or higher.
15877275|NCT03825549|Behavioral|Peer comparison feedback|"Practice sites randomly assigned to have peer comparison feedback will be sent information by email to each clinician at the site each month for the duration of the intervention period. Data on the mean number of opioid pills per prescription and the proportion of visits with an opioid prescription will be delivered using a 3-month rolling average as follows: a) If clinician is above median: informed how their data compares to the median; b) If clinician is below median but above 10th percentile: informed how their data compares to the 10th percentile; c) If clinician is 10th percentile or below: informed of their data and commended for being a low prescriber."
15877276|NCT03825536|Drug|Oral Methamphetamine|In this phase IV open label double-blind randomized crossover study, participants will be randomized to either of two treatment arms, oral methamphetamine or placebo, using a crossover design with a 31-day washout period in between treatment arms. For the oral methamphetamine treatment arm, an initial 10 mg of oral methamphetamine (over-encapsulated to look similar to placebo capsule) study drug will be administered to assess tolerability, followed by a subsequent 15 mg oral dose (over-encapsulated to look similar to placebo capsule) two hours later.
15877342|NCT03825042|Dietary Supplement|A mix of bioactive natural compounds|A mix of bacopa, lycopene, astaxanthin and vitamin B12 in oral tablets
15877343|NCT03825042|Dietary Supplement|Placebo|Inactive compound in oral tablets
15877277|NCT03825536|Other|Placebo oral capsule|In this phase IV open label double-blind randomized crossover study, participants will be randomized to either of two treatment arms, oral methamphetamine or placebo, using a crossover design with a 31-day washout period in between treatment arms. For placebo treatment phase, one placebo capsule will be administered orally on treatment day, followed by a second oral placebo capsule two hours later.
15877278|NCT03825523|Other|iART|After group assignment, ART will be started within the first 48 hours after admission to the hospital. ART regimen will be decided according to each subject´s the clinical characteristics
15877279|NCT03825523|Other|cART|After group assignment, ART is started at the discretion of the attending physician. ART regimen will be decided according to each subject´s the clinical characteristics
15877280|NCT03825510|Radiation|Stereotactic Body Radiotherapy|"All patients in this trial will be treated with fractionated Stereotactic body radiation therapy.
~SBRT will be delivered to <=3 sites in 3-5 fractions followed by administration of the specified immunotherapy agent (Nivolumab or Pembrolizumab). This approach will take advantage of the transient increase in antigen availability, increased antigen presentation and upregulation of PD-1 by tumor cells following ablative radiation therapy."
15877281|NCT03825497|Other|Promotion of activity during and after hospitalization|1) a welcome folder encouraging physical activity; 2) encouragement to use a walk path established in the ward; 3) encouragement to use posters containing exercise suggestions;4) prescription of a walk-plan for in-hospital use; 5) encouragement to pick up clothes and beverages by oneself; 6) prescription of a walk-plan at discharge for at home use 7) follow-up on walk plan after discharge by municipality
15877282|NCT03825484|Drug|Erdafitinib|Participants will start erdafitinib 8 milligram (mg) (formulated as tablets with 3 mg, 4 mg and 5 mg dosages) orally once daily until disease progression, intolerable toxicity, withdrawal of consent or decision by the doctor to discontinue treatment. Dose will be up-titrated to 9 mg based on serum phosphate levels and if there is no drug-related toxicity.
15877283|NCT03825471|Procedure|electrotherapy|Cranial electrotherapy stimulation
15877284|NCT03825471|Drug|Opioid Anesthetics|consumption of opioids during general anesthesia
15877285|NCT03825471|Procedure|colon cancer surgery|laparoscopic colon cancer surgery
15877286|NCT03825458|Other|Blood sampling|Blood sampling at each clinical follow-up visit.
15877287|NCT03825445|Drug|GnRHa (Fertipeptil 0.1mg)|Two doses of GnRH-a (Fertipeptil 0.1mg x 2 vial) for ovulation trigger after ovarian stimulation for IUI.
15877288|NCT03825445|Drug|hCG (Pregnyl 5000IU)|hCG (Pregnyl 5000IU) for ovulation trigger after ovarian stimulation for IUI.
15877289|NCT03825380|Drug|Bimatoprost|Eyedrops
15877290|NCT03825380|Drug|Lumigan®|Eyedrops
15877291|NCT03825367|Drug|Nivolumab|"The dose of Nivolumab will be 3 mg/kg which is the adult recommended dose and is the recommended dose in children in the phase 2 portion of COG ADVL1412.
~If 3 mg/kg is not tolerated in combination with 5-azacytidine, the dose will be stepped down to 1 mg/kg."
15877292|NCT03825367|Drug|5-azacytidine|75mg/m2 subcutaneously will be given daily for 7 days on days 1 to 7.
15877293|NCT03825354|Behavioral|BIC|World Health Organization, WHO, Brief Intervention and Contact (BIC)
15877294|NCT03825341|Drug|Hydroxyurea|Drug: Hydroxyurea oral liquid dose administered will be 20mg/kg/day or infants's usual daily dose.
15877295|NCT03825341|Drug|Hydroxyurea Oral Capsule|Drug: Hydroxyurea both a sprinkle formulation and capsules (Droxia 200mg) administered on 2 separate occasions.
15877296|NCT03825328|Drug|Albumin-bound paclitaxel|Albumin-bound paclitaxel is paclitaxel formulated as albumin-bound nanoparticles with a mean particle size of approximately 130 nanometers.
15877297|NCT03825328|Drug|S-1|a combination preparation of tegafur, gimeracil, and oteracil potassium
15877298|NCT03825328|Drug|Oxaliplatin|The compound features a square planar platinum(II) center. In contrast to cisplatin and carboplatin, oxaliplatin features the bidentate ligand 1,2-diaminocyclohexane in place of the two monodentate ammine ligands. It also features a bidentate oxalate group.
15877299|NCT03825328|Drug|Gemcitabine|Gemcitabine is a synthetic pyrimidine nucleoside prodrug-a nucleoside analog in which the hydrogen atoms on the 2' carbon of deoxycytidine are replaced by fluorine atoms.
15877300|NCT03825315|Biological|DAXI for Injection: LOW Dose|DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline.
15877301|NCT03825315|Other|DAXI for Injection: HIGH Dose|DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline.
15877302|NCT03825315|Other|Placebo|Placebo is a sterile lyophilized product consisting of inactive ingredients without the neurotoxin to be reconstituted with sterile, non-preserved 0.9% sodium chloride solution.
15877303|NCT03825302|Diagnostic Test|Methacholine challenge|Methacholine inhalation challenge will be administered to both male and females with asthma
15877304|NCT03825302|Diagnostic Test|Mannitol challenge|Mannitol inhalation challenge will be administered to both male and females with asthma
15877307|NCT03825276|Dietary Supplement|Mango consumption|Daily consumption of 280 g of frozen mangos during 8 weeks. The daily dose in equivalent to a 2-cups serving.
15877308|NCT03825263|Device|Intermittent Pressure Compression|The intervention group use the IPC device for 6 months. Clinic assessment were completed at the beginning and at 3 and 6 months. Participants in the intervention group were invited to use the IPC device twice a day every day during this period.
15877309|NCT03825250|Drug|Sodium Valproate|Treatment with Sodium Valproate vs. Control Discovery phase - 4 arms: 15 mg/kg for 1-2 weeks; 15mg/kg for 4-6 weeks; 25 mg/kg for 4-6 weeks; Control Efficiency phase - 2 arms: Treatment group selected from previous phase; Control
15877344|NCT03825029|Procedure|Pillow|A pillow to lessen the angle differences between hips so that the acetabular component can be placed in an optimal position.
15877345|NCT03825016|Drug|Lidocaine Hydrochloride|Lidocaine infusion on hystroscopic media during office hystroscopy
15877346|NCT03825016|Drug|Diclofenac Sodium|Oral Diclofenac Sodium
15877454|NCT03824132|Behavioral|Improvisational comedy classes|6 consecutive improvisational comedy classes
15877310|NCT03825237|Diagnostic Test|Polysomnography|The polysomnography (referred to as type I) allows assessing several sleep physiologic parameters (eg, EEG, electrooculogram, electromyogram, electrocardiogram, airflow, respiratory effort, oxygen saturation), whereas audio-video recording enables documenting tooth-grinding sounds and distinguishing between rhythmic masticatory muscle activity (RMMA) and orofacial (eg, swallowing) and other muscular activity (eg, head movements) during sleep. Based on the RMMA index (number of episodes per hour of sleep), sleep bruxism is diagnosed when RMMA episodes are greater than or equal to 2 (low-frequency SB, mild bruxism) or RMMA episodes are greater than or equal to 4 (high-frequency SB, severe bruxism)
15877311|NCT03825224|Procedure|Diagnostic Test: Myostrain|This test measures the contraction of the heart muscle in one to three heartbeats per plane. It's a pulse sequence that produces images that reveal the underlying contraction fo the muscle of a healthy heart and associated weaknesses in case of disease.
15877312|NCT03825211|Procedure|Continuous suture in the perineals lesions|A continuous suture of the vagina, muscle and skin is performed continuously, without knotting or cutting the suture thread.
15877313|NCT03825211|Procedure|Discontinuous suture in the perineals lesions|Suture the muscle independently of the vagina and independently of the skin
15877314|NCT03825198|Procedure|Erector spinae plane block|Ultrasound guided deposition infiltration between a lumbar transverse proces and the erector spine muscle
15877315|NCT03825198|Drug|Levobupivacaine 0,25%|20 ml levobupivacaine 0,25% used for the infiltration between the transverse process and the erector spinal muscle
15877316|NCT03825198|Procedure|spine fusion|fusion of lumbar vertebral body on 1 or two levels
15877317|NCT03825198|Drug|NaCL 0,9%|20 ml solution used for the infiltration between the transverse process and th erector spinal muscle
15877318|NCT03825198|Drug|Sufentanil|opioid used for the preoperative analgesia for back surgery during general anaesthesia ( 15 mag)
15877319|NCT03825198|Drug|propofol|induction agent for general anaesthesia ( 2-3 mg/kg)
15877320|NCT03825198|Drug|Rocuronium Bromide|muscle relaxant used during general anaesthesia ( 0,5 mg/kg)
15877321|NCT03825198|Drug|sevoflurane|inhalation aesthetic used for the maintenance of general anaesthesia
15877322|NCT03825198|Drug|paracetamol|postoperative drug for analgesia ( 1 gram 4/day)
15877323|NCT03825198|Drug|Ketorolac|non steroidal into inflammation drug used for postoperative analgesia (0,5 mg/kg)
15877324|NCT03825198|Drug|morphine pca|postoperative morphine pomp, controlled by the patient. ( bolus 1 mg, lockout 8 minutes) the solution contains morphine 1 mg/ml + dehydrobenzperidol 0,05 mg/ml
15877325|NCT03825198|Drug|Dexamethasone|drug given during general anaesthesia to prevent postoperative nausea
15877326|NCT03825198|Drug|Morphine|loading dose morhine 0,1 mg/kg at the end of surgery
15877327|NCT03825185|Procedure|Transcervical Thymectomy|Transcervical Thymectomy. All transcervical thymectomies were performed with an 8 cm transversal cervicotomy was performed approximately 2 cm above the sternal notch. Musculocutaneous flaps were developed up to the thyroid cartilage and the suprasternal notch. Strap muscles were split in the middle and retracted laterally. The upper horns of the thymus were exposed and were freed up to the level of the innominate vein. All tributary veins were suture ligated. A sternal retractor was then placed to retract the sternum upward until the patient was nearly lifted off the table. The rest of the Thymus was dissected, from the pericardium and the pleura. Care was specially taken to remove as much fatty tissue adjacent to the thymus as possible preserving the phrenic nerves.
15877328|NCT03825185|Procedure|Transsternal Thymectomy|Transsternal Thymectomy. A standard formal median sternotomy was carried out. The sternum was retracted laterally using an automatic retractor. All thymic tissue with the adjacent adipose tissue was removed starting with the inferior horns of the thymus. Thymic vessels were ligated and dissection was continued until the upper horns could be separated from the thyroid. A mediastinal tube was placed before closing the sternum and was kept in close suction for 2 to 3 days.
15877329|NCT03825172|Diagnostic Test|Caudal Epidural Ultrasonography|Ultrasonographic Measurement
15877330|NCT03825159|Device|Spinal Orthosis with an Integrated System of Electric Surface Stimulation and Heat Sensing|The electrical stimulation technology integrated with the total contact spinal orthosis combines the external correction forces on the spinal skeleton from the passive orthosis with the muscle forces at the lateral trunk from the stimulation process.
15877331|NCT03825159|Device|spinal orthosis|The ventrally opened total contact spinal orthosis will be designed and made of Copolymer and Aliplast. Correcting pressure points have to use the pressure pads at relevant points.
15877332|NCT03825146|Biological|Autologous Multi-lineage Potential Cells (AMPC)|"Multi-lineage potential cells which were induced to de-differentiate from somatic leukocytes from peripheral blood. Cells are autologous with respect to the patient, and are prepared in a suspension and administered via intravenous infusion.
~An estimated average of 1 x 10^8 (0.5 to 5.0 x 10^8) cells/per suspension(275 to 450mL) will be infused into the patient via intravenous infusion on day 5. Cell counts depend on yield of initial leukocyte harvest on day 0."
15877333|NCT03825133|Procedure|Bone Marrow Aspirate Concentrate|Bone marrow ( 100 ml) is aspirated from proximal tibia, concentrated in Arthrex Angel Centrifuge, and after concentration 6 ml of BMAC is injected in the knee
15877334|NCT03825133|Procedure|Leukocyte Rich Platelet Rich Plasma|Blood sample is taken ( 100 ml), centrifuged in Arthrex Angel Centrifuge and after double spinning process about 6 ml of PRP is injected in the knee
15877335|NCT03825133|Drug|Hyaluronic Acid|Three injections of Cartinorm (1% Sodium Hyaluronat (20mg/2 ml) by Goodwill Pharma) is injected in the knee weekly
15877338|NCT03825094|Device|DyeVert™ Contrast Reduction Systems|Osprey Medical DyeVert™ Contrast Reduction Systems (DyeVert Systems) provide fluid pathway resistance modulation such that excess contrast media (CM) (i.e. CM that is not needed for diagnostic or therapeutic purposes) is minimized in the patient's vasculature and total contrast media volume (CMV) reduction occurs, while maintaining adequate image quality.
15877339|NCT03825081|Drug|Brimonidine, pilocarpine|"1 drop of pilocarpine (0.5%)
~1 drop of brimonidine (0.2%)"
15877340|NCT03825068|Procedure|ESP Block|20 ml of lacal anaesthetics will be placed below the erector spinae muscle under ultrasound guide
15877341|NCT03825068|Drug|general anesthetic|patient receive general anaesthetic only
15877347|NCT03824990|Behavioral|Quality improvement of management of neonatal jaundice|During the Intervention phase and Sustainability phase ,The hospitals will receive training of multiple evidence based quality improvement methods.
15877348|NCT03824977|Diagnostic Test|Six minutes stepper test|The patient carries out the two tests before surgery then we observe the occurrence of postoperative complications
15877349|NCT03824964|Biological|Anti-CD19/CD22 CAR NK Cells|Total dose of 50-600 thousand /kg Anti-CD19/CD22 CAR NK cells will be administered at day0
15877350|NCT03824951|Biological|Anti-CD19 iCAR NK Cells|Anti-CD19 iCAR NK Cells injection
15877351|NCT03824938|Drug|Aspirin 650mg Oral Capsule|A 650mg dose of aspirin is administered in the laboratory one hour before participant completes a maximal exercise test.
15877352|NCT03824938|Drug|Acetaminophen Tab 650mg|A 650mg dose of acetaminophen is administered in the laboratory one hour before participant completes a maximal exercise test.
15877353|NCT03824938|Other|Placebo|A placebo pill is administered in the laboratory one hour before participant completes a maximal exercise test.
15877354|NCT03824925|Drug|Placebo oral Zinc capsule|Look alike cap of corn starch as a placebo of Zinc to be given on day 1 of chemo-radiotherapy
15877355|NCT03824925|Drug|Zinc Sulfate 220 MG|Zinc sulfate in test group dose was 220 mg which is equivalent to 50 mg of elemental zinc
15877356|NCT03824912|Drug|Ketoconazole Cream 2%|Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.
15877357|NCT03824912|Drug|Ketoconazole Cream 2% (G&W Laboratories Inc.)|Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.
15877358|NCT03824912|Drug|Placebo|Patients will be instructed to apply sufficient study product to cover affected and immediate surrounding areas once daily for 42 ± 4 days. Each patient is expected to receive 42 ± 4 doses.
15877359|NCT03824899|Diagnostic Test|Blood concentration check|Blood concentration check：the plasma concentration of SN-38 was detected by HPLC (high-performance liquid chromatography) at 1.5 h and 49.0 h after CPT-11 infusion
15877360|NCT03824886|Other|Implementation of skin care algorithm|Implementation of structured and standardized skin care regimen
15877361|NCT03824873|Procedure|Internal iliac artery ligation|Internal iliac artery ligation and cesarean hysterectomy
15877362|NCT03824873|Procedure|cesarean hysterectomy|cesarean hysterectomy
15877363|NCT03824860|Behavioral|Yoga|"Participants will attend at least one group class per week (in-person or Zoom) and practice one self-guided yoga video class at home on their own per week, over eight weeks
~Participants may choose to attend Flow Yoga and/or Chair Flow Yoga classes. These classes will be videotaped and made available to participants electronically.
~Classes consist of:
~guided breathing exercises,
~upper and lower extremity stretching
~structured postures and movements to improve balance and strength"
15877364|NCT03824847|Drug|Clarithromycin 250 MG|Clarithromycin 1 tablet (250mg) twice daily for three days
15877365|NCT03824847|Drug|Placebos|Placebo group: (identical-looking) placebo 1 tablet twice daily for three days
15877366|NCT03824834|Drug|Exercise training with morphine|Immediate-release oral morphine (syrup, 0.1 mg/kg body mass to a maximum dose of 10 mg) prepared in 250 mL of orange juice 30-min prior to each exercise session. Participants will complete exercise training sessions (three times per week for five weeks) on an electronically braked bike, supervised by a trained exercise specialist. Exercise sessions will be individualized based on participants' peak power output (60% PPO) determined from incremental exercise testing, and progressed to ensure the participant is exercising at a breathlessness intensity rating of between 3-5 Borg CR10 scale units and can complete at least 20-min of continuous cycling. Exercise duration will be increased in 5-min intervals up to 40-min. Thereafter, exercise intensity will be increased by 5-15% of baseline PPO.
15877367|NCT03824834|Other|Exercise training with placebo|Diluted simple syrup prepared in 250 mL of orange juice 30-min prior to each exercise session. Participants will complete exercise training sessions as per the experimental group.
15877368|NCT03824821|Other|No intervention|No intervention
15877369|NCT03824808|Drug|Lidocaine Hydrochloride 0.8% in Dextrose 5% Solution|Lidocaine Hydrochloride and 5% Dextrose Injection, USP is a sterile, nonpyrogenic solution prepared from lidocaine hydrochloride and dextrose in water for injection.
15877370|NCT03824808|Drug|0.9% Sodium Chloride Injection|Sodium Chloride Injection USP is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents.
15877371|NCT03824795|Drug|MGB-BP-3|MGB-BP-3
15877372|NCT03824782|Device|Phototherapy Mask|A standard phototherapy mask (Biliband, Natus, Pleasanton, California, USA) applied over the eyes after instillation of mydriatic drops. The masks will be removed 4 hours after the eye examination, when the pharmacologic effect of the mydriatic agents would have subsided.
15877373|NCT03824769|Behavioral|Weight Loss Maintenance + Healthy Thinking|Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will be asked to read short passages related to nutrition and a healthy lifestyle through our study website twice a day for the duration of treatment.
15877374|NCT03824769|Behavioral|Weight Loss Maintenance Treatment + Future Thinking|Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive a 4-month behavioral weight maintenance intervention consisting of 7 sessions that focus on evidence-based weight management strategies focused on diet, exercise, and behavioral skills. In this treatment, participants will create descriptions of upcoming positive events and will be asked to read short passages through our study website at least twice a day for the duration of treatment.
15877375|NCT03824756|Other|NGO supported GMP program|An International NGO has signed a contract with Government to support in implementing the growth Monitoring and Promotion (GMP) program. This program will be implemented at Community clinics. It will ensure the sustainability of community clinics in the selected areas through capacity building and follow up with community groups, community support groups, and Government Health and Family Planning service providers.
15877376|NCT03824756|Other|Non-supported GMP program|This is control arm of the study. In this arm, there will be Government's usual GMP program implemented at community clinics without any NGO support.
15877379|NCT03824730|Device|Stenting of the Common and/or External Iliac Arteries|"Stenting of the Common and/or External Iliac Arteries was performed in the angiographic suite. Under local anesthesia, arterial access was obtained through standard percutaneous puncture of the common femoral artery, brachial approach, or simultaneous brachial and femoral approach.
~Iliac lesion crossing was achieved through intraluminal or subintimal manner depending on the behavior of the lesion intraoperatively.
~Predilatation of the occlusion before stent deployment was performed at the discretion of the operator.
~Balloon-expandable stents were used for proximal, ostial lesions, whereas self-expanding stents were deployed in all other lesions.
~Both stents were used in long lesions involving heavily calcified common iliac arteries."
15877380|NCT03824717|Drug|Dose of ropivacaine|Biased coin design up and down dose finding study of 0.5% ropivacaine to achieve a successful infraclavicular brachial plexus block
15877381|NCT03824704|Drug|Rucaparib|Oral rucaparib will be administered twice daily
15877382|NCT03824704|Drug|Nivolumab|IV nivolumab will be administered once every 4 weeks
15877383|NCT03824691|Drug|Cabozantinib|cabozantinib 40 mg orally once daily
15877384|NCT03824691|Drug|Durvalumab|1500 mg durvalumab (MEDI4736) IV infusion every 28 days
15877385|NCT03824678|Drug|CC-220|CC-220
15877386|NCT03824665|Drug|Nalbuphine Group|"All patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive
~Patients were categorized into three groups according to the type of additive used with the LAM as follows:
~Group N:(Nalbuphine group)1 ml saline containing 4mg nalbuphine used instead of normal saline"
15877387|NCT03824665|Drug|Fentanyl Group|"All patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive
~Patients were categorized into three groups according to the type of additive used with the LAM as follows:
~Group F: :(Fentanyl group)1 ml saline containing 20 μg fentanyl used instead of normal saline"
15877388|NCT03824665|Drug|Control Group|"All patients received 8 ml of LAM which consisted of: 6 ml of ml of bupivacaine 0.5%, 1 ml of hyaluronidase containing 150 IU, 1 ml of additive
~Patients were categorized into three groups according to the type of additive used with the LAM as follows:
~Group C (Control group): included patients assigned to receive 1 ml normal saline."
15877389|NCT03824652|Other|walnuts|2 ounces of walnuts daily for 4-10 weeks
15877390|NCT03824652|Other|usual diet|Subject continues usual diet
15877391|NCT03824652|Other|phone counseling with dietitian|Weekly calls with dietitian
15877392|NCT03824639|Behavioral|Structured exercise|Exercise instruction and encouragement
15877393|NCT03824639|Behavioral|Health Education|Provision of general information about a variety of health topics
15877394|NCT03824626|Diagnostic Test|TEVAR patients|Computed Tomography Angiography (CTA) will be performed using a 16-slice unit before and after intravenous administration of 100 mL of iodinated contrast material. Phase contrast-Magnetic Resonance (pc-MRI) will be performed using a 1.5-T unit with 40-mT/m gradient power and a four-channel cardio-thoracic coil. ECG-triggered, free-breathing through plane, and in-plane pc-MRI sequences will be performed for phase-velocity mapping of aortic and branches flow. Ad hoc processing of preoperative CTAs, based on 3D multiplanar reconstruction, will be performed with 3Mensio Vascular software 8.0® (3Mensio Medical Imaging B.V.), which provides specific functions for automatic measurements.
15877395|NCT03824613|Diagnostic Test|Urinary miRNA|MiRNA detection in urine
15877396|NCT03824600|Diagnostic Test|Fractional Flow Reserve Motorized Pullback|A pullback device (Volcano R 100, San Diego CA, USA), adapted to grip the coronary pressure wire (PressureWire X, St Jude Medical, Minneapolis, USA), set at a speed of 1 mm/sec to pullback the pressure-wire until the tip of the guiding catheter during continued pressure recording.
15877397|NCT03824587|Drug|Tenapanor|Active Drug
15877398|NCT03824587|Drug|Placebo|Inactive Drug
15877399|NCT03824587|Drug|Phosphate Binder Agents|standard of care phosphate binder use at study entry was maintained throughout the entire study
15877400|NCT03824574|Device|Clear Mandibular Advancement Appliance|Clear Mandibular Advancement Appliance for treatment of skeletal class II patients with retrognathic mandible
15877401|NCT03824561|Drug|Vedolizumab|Vedolizumab IV infusion
15877402|NCT03824548|Other|this is non-intervention study, there is no intervention drug or device in this study.|this is exactly a non-interventional study, no intervention during the whole study.
15877403|NCT03824535|Procedure|Computed Tomography|Undergo PET/CT
15877404|NCT03824535|Drug|Fludeoxyglucose F-18|Given IV
15877405|NCT03824535|Drug|Fluorine F 18 L-glutamate Derivative BAY94-9392|Given IV
15877406|NCT03824535|Procedure|Positron Emission Tomography|Undergo PET/CT
15877407|NCT03824522|Biological|ADYNOVATE|Pegylated recombinant human factor VIII
15877408|NCT03824509|Other|Chart Review|"Study staff at PBMC (Cardiologist and two clinical researchers) will be responsible for maintaining all data related to this study in REDCap. Patient data to be included in this secondary data analysis will originate from MMC and PBMC.
~Case-patient data to be included from MMC will be identified by an EPIC data request from Enterprise Reporting. The elements of the data request will be patients who have had a stroke or TIA, atrial fibrillation, and a transthoracic echocardiogram at MMC from 2014-2017."
15877409|NCT03824496|Diagnostic Test|Cranial Accelerometry Measurement|Measuring the HeadPulse using cranial accelerometry
15877410|NCT03824483|Drug|Zanubrutinib|zanubrutinib (160mg by mouth BID)
15877411|NCT03824483|Drug|Obinutuzumab|"obinutuzumab (1000mg IVPB on Days 1*, 8 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 8) starting on Cycle 1 (28-day cycles). * On Cycle 1, obinituzumab will be administered in split dose at 100mg IVPB on Day 1 and 900mg IVPB on Day 2 in patients at increased risk for IRR (ALC >25,000 cells/ul or baseline lymph nodes >5 cm diameter)."
15877412|NCT03824483|Drug|Venetoclax|Venetoclax will be added to the regimen starting on Cycle 3, and will be incorporated into the regimen using the 5-week ramp-up schedule to mitigate the risk of tumor lysis syndrome (beginning at 20mg and gradually increasing to 400mg), and venetoclax will be administered a ta fixed dose level of 400mg by mouth daily of 28-day cycles thereafter.
15877413|NCT03824457|Drug|Rheosorbilact®|Rheosorbilact® is administered as a part of the infusion therapy intravenously (with speed 40-60 drip per minute) at a dose of not more than 400 ml (6 to 7 ml/kg body weight per 24 hours) for 3 days.
15877455|NCT03824132|Behavioral|Waitlist control|After 10 week waitlist control, subjects will complete 6 consecutive improvisational comedy classes.
15877414|NCT03824457|Drug|Ringer lactate|Rheosorbilact® is administered as a part of the infusion therapy intravenously (with speed 40-60 drip per minute) at a dose of not more than 400 ml (6 to 7 ml/kg body weight per 24 hours) for 3 days.
15877415|NCT03824444|Device|PODS|Percutaneous Osseointegrated device for transhumeral patients
15877416|NCT03824431|Diagnostic Test|Endoscopic esophageal biopsies|
15877417|NCT03824418|Procedure|Surveillance colonoscopy with chromoendoscopy|Surveillance colonoscopy with chromoendoscopy
15877418|NCT03824405|Drug|BTX 1204|BTX 1204 liquid formulation
15877419|NCT03824405|Drug|Vehicle|Vehicle liquid formulation
15877420|NCT03824392|Biological|ATYR1923 1.0 mg/kg or placebo|ATYR1923 participants to receive ATYR1923 1.0 mg/kg IV every 4 weeks; Placebo participants to receive placebo IV every 4 weeks
15877421|NCT03824392|Biological|ATYR1923 3.0 mg/kg or placebo|ATYR1923 participants to receive ATYR1923 3.0 mg/kg IV every 4 weeks; Placebo participants to receive placebo IV every 4 weeks
15877422|NCT03824392|Biological|ATYR1923 5.0 mg/kg or placebo|ATYR1923 participants to receive ATYR1923 5.0 mg/kg IV every 4 weeks; Placebo participants to receive placebo IV every 4 weeks
15877423|NCT03824379|Dietary Supplement|Magnesium citrate|magnesium citrate equivalent 20-30 mmol elemental magnesium
15877424|NCT03824379|Drug|Antidiabetic|insulin or oral hypoglycemics
15877425|NCT03824366|Device|Volumetric MR imaging|This will most frequently be supine with arms positioned so not in the way of treatment beams.
15877426|NCT03824366|Radiation|Radiation therapy|-Standard of care
15877427|NCT03824353|Behavioral|Social Intelligence Training|The social intelligence training consists of short 5-10 minute sessions organized into 7 modules designed to raise awareness of human nature and social relationships. The approach is based on evidence that social intelligence training is best advanced through interventions that modify key social cognitions regarding social engagement and enhance efficacy expectations regarding performance in social situations.
15877428|NCT03824353|Behavioral|The Healthy Living Program|A placebo condition delivered online which presents health-related information only.
15877429|NCT03824340|Drug|Doxycycline before ICSI|Extra medication (Doxycycline ) group before ICSI :,women who will receive more medications (Doxycycline ) before starting the ICSI process
15877430|NCT03824327|Procedure|Blood Oxygen Level Dependent Imaging|Undergo BOLD fMRI
15877431|NCT03824327|Drug|Papaverine Hydrochloride|Given IV
15877432|NCT03824327|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15877433|NCT03824314|Drug|Midazolam|2 ml of 0.5% isobaric levobupivacaine (10 mg) plus 0.5 ml midazolam (2 mg)will be given intrathecally in L3 and L4 space with 25 gauge Quincke spinal needle via midline approach in sitting position. On free flow of cerebrospinal fluid, study drug will be injected intrathecally . Patients will immediately turn to supine position
15877434|NCT03824314|Drug|Fentanyl|2 ml of 0.5% isobaric levobupivacaine (10 mg) plus 0.5 ml fentanyl (25 μg)will be given intrathecally in L3 and L4 space with 25 gauge Quincke spinal needle via midline approach in sitting position. On free flow of cerebrospinal fluid, study drug will be injected intrathecally . Patients will immediately turn to supine position
15877435|NCT03824301|Device|Volume controlled ventilation|Changing modes of ventilation during cardiopulmonary bypass
15877436|NCT03824301|Device|Pressure controlled ventilation|Applying pressure controlled ventilation during cardiopulmonary bypass Period
15877437|NCT03824288|Diagnostic Test|Intraoral ultrasound|The ultrasound transducer (either Hockey Stick or Burr-Hole N11C5s transducer from BK Ultrasound) is placed on the palatoglossal arch on the affected side and sweeped from the cranial to caudal end of the tonsil to look for an abscess cavity identified as a hypoechoic area with ill-defined margins.
15877438|NCT03824288|Procedure|The landmark technique|A 14G needle aspiration is inserted blindly in the superior tonsil pol where pus aspiration is attempted.
15877439|NCT03824275|Drug|18F- DCFPyL PET/CT|A CT scan using a radioactive marker to better image tumors
15877440|NCT03824262|Device|HICO-VARIOTHERM 550|Warming during perioperative period.
15877441|NCT03824262|Device|Mistral-Air Plus forced air warming device|Warming during perioperative period.
15877442|NCT03824249|Diagnostic Test|Indirect Calorimetry|Performance of indirect calorimetry in Canopy mode.
15877443|NCT03824236|Biological|RTS,S/AS01E (SB257049)|Subjects from the P-Fx and NP-Fx groups will receive one Fx booster dose of RTS,S/AS01E at Day 1.
15877444|NCT03824223|Diagnostic Test|Hypoxic challenge test|Physiological response to 15% ambient oxygen monitored.
15877445|NCT03824210|Other|App|Mobile phone app
15877446|NCT03824197|Other|EVOO|Extra-virgin olive oil that is rich with oleocanthal and other phenols.
15877447|NCT03824197|Other|OO|Olive oil low in oleocanthal and other phenols.
15877448|NCT03824184|Procedure|manipulation of endometrium|Manipulation of endometrium with saline
15877449|NCT03824171|Drug|Raloxifene 60mg/Cholecalciferol 800IU|Raloxifene 60mg/Cholecalciferol 800IU tablet
15877450|NCT03824171|Drug|AD-102|AD-102 Raloxefene 45mg/Cholecalciferol 800IU tablet
15877451|NCT03824158|Behavioral|Facilitated advance care planning (in-person or telephonic)|The facilitator will contact the patient to schedule the ACP discussion. ACP discussions will be led by a nurse or social worker with supportive oncology experience who has been trained as a Respecting Choices facilitator, include the patient's caregiver when available, last 45-60 minutes, and be held in a private location at or near the patient's oncology clinic, or telephonically. Facilitators will use a structured interview tool as a discussion roadmap and provide guidance in choosing a medical decision maker, exploring serious illness understanding and experiences, identifying goals and values, and making future treatment decisions. Facilitators will provide a copy of a written advance directive, assist with completion when appropriate, and make recommendations for communicating goals and sharing written preferences.
15877452|NCT03824158|Behavioral|Web-based advance care planning|Instructions for accessing and using the PREPARE website will be shared with participants upon randomization. Patients and their caregivers review the 5 steps of PREPARE (approximately 10 minutes per step) and create an action plan for each step. The PREPARE website includes a link to a written advance directive that participants are able to complete. The PREPARE website can be reviewed on a home computer or on a tablet in the oncology practice.
15877453|NCT03824145|Behavioral|Lifestyle Intervention|The lifestyle intervention is a 12-week cognitive-behavioral intervention that addresses key changes in diet and PA behaviors to promote positive body composition changes.
15877456|NCT03824119|Drug|Ibuprofen 600 mg|Standard postpartum care (including administration of NSAIDs)
15877457|NCT03824119|Other|Standard Postpartum Care without NSAIDs|NSAID administration will be withheld from this group.
15877458|NCT03824106|Behavioral|Socialization|Social interaction is associated with better mental and physical health, and evidence suggests that group versus individual engagement may offer unique cognitive benefits for older adults as well as peer reinforcement and encouragement.
15877459|NCT03824106|Behavioral|Group Exercise|A recent meta-analysis suggests 180 min/week of exercise (with a high challenge to balance) is most effective for fall prevention. Combined strength and endurance training performed at a moderate weekly frequency (i.e., two times per week) may promote marked gains on muscle hypertrophy, strength and power gains in frail older adults. Balance training is a key component of successful exercise programs for vulnerable older adults.
15877460|NCT03824106|Combination Product|Nutrition and Medication review|"Nutrition review: Conduct nutritional screening flow and review any questions, provide some additional counseling/coaching at follow-up visits. Protein supplements will be provided to all participants unless contraindicated.
~Medication review: Review/update current medication list and forward the list and medical history to the consultant study pharmacist. The study pharmacist will utilize TAPER and Start /STOPP criteria (based on a medication review process we have piloted in our Fit Joints study) and provide recommendations to the participant's family physician. Study geriatricians will be listed as contacts on the primary care provider recommendations and available for consultation."
15877461|NCT03824106|Dietary Supplement|Protein Supplement|As piloted in our Fit Joints Study, the protein supplement (each serving) contains 350 kcal, 20-gram protein, 1.5 g β-Hydroxy β-Methylbutyrate (HMB), and participants are advised to take this with a meal or within 3 hours of exercise on activity days. A study nurse (trained in geriatrics) will schedule Arm 3 participants for an initial assessment appointment with two more follow-up appointments (over the first couple of months, as required). Working in consultation with the study geriatricians and pharmacist, as required, the multi-modal arm nurse assessment will include: 1) Review the participants' relevant medical history building on the screening intake form completed by primary care provider.
15877462|NCT03824106|Dietary Supplement|Vitamin D|1000 IU of oral vitamin D
15877463|NCT03824093|Behavioral|AFIX Only|The intervention will include an in-person AFIX assessment of the practice's adolescent vaccination rates.
15877464|NCT03824093|Behavioral|AFIX+ Provider Communication Training|The intervention will include an in-person AFIX assessment of the practice's adolescent vaccination rates along with communication training for providers and poster and brochure displays.
15877465|NCT03824080|Drug|Bemcentinib|"Bemcentinib will be self-administered orally (fasted) at a dose mentioned above for a total of at least 4 cycles daily.
~Responding patients (defined as at least stable disease) are eligible for up to 5 additional cycles according to the maintenance daily dosing of 2 x 1 capsules of 100 mg for each 28 days cycle (up to 9 cycles in total)."
15877466|NCT03824067|Diagnostic Test|Point of Care Early Infant Diagnosis|HIV testing where the blood sample is processed at either the facility itself or a nearby site that is closer to the facility than a laboratory. With POC EID, blood samples do not have to travel to the laboratory for processing.
15877467|NCT03824067|Diagnostic Test|Standard of Care Early Infant Diagnosis|Conventional laboratory based EID testing
15877468|NCT03824054|Procedure|colorectal resection|Surgery includes laparoscopic resection of all visible endometriosis, including resection of the affected bowel with primary anastomosis
15877469|NCT03824041|Dietary Supplement|Aronia full spectrum - half dose|Powdered whole fruit obtained from aronia berries (Aronia melanocarpa)
15877470|NCT03824041|Dietary Supplement|Aronia full spectrum - full dose|Powdered whole fruit obtained from aronia berries (Aronia melanocarpa)
15877471|NCT03824041|Dietary Supplement|Placebo|Identical formulation as the treatment consisting of colored maltodextrin using artificial colors.
15877472|NCT03824028|Device|Clareon® IOL AutonoMe™ automated preloaded delivery system|Disposable injector preloaded with the Clareon IOL for precise IOL insertion during cataract surgery
15877473|NCT03824015|Behavioral|Keeping Adults Physically Active (KAPA) intervention|The Keeping Adults Physically Active (KAPA) intervention included six 60-90 minute group motivational interviewing sessions which were supported by a pedometer and a file containing information about locally run physical activity services, a home exercise booklet and written information on different types of lifestyle and transport related physical activity. During sessions the KAPA participants created physical activity plans and reflected on their physical activity diaries and personal physical activity goals. Various sub-sets of behaviour change techniques were delivered to help support the participants in continuing to be active.
15877474|NCT03824015|Other|Usual Care|Usual care was delivered for the duration of the KAPA feasibility study. The usual care participants finished the original Falls Management Exercise program and went on to being offered the service provider's usual care package. Upon initiating the KAPA feasibility study it was unknown what the service provider would deliver as usual care. Therefore a study objective was to describe the usual care package delivered by the service providers.
15877475|NCT03824002|Drug|Dulaglutide|Diabetes therapy with dulaglutide and various combinations of insulin, metformin, glinides
15877476|NCT03824002|Drug|Aspart insulin|Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
15877477|NCT03824002|Drug|Glargine|Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
15877478|NCT03824002|Drug|Metformin|Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
15877479|NCT03824002|Drug|Repaglinide|Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide
15877480|NCT03823989|Drug|Promitil|The first 6 patients recruited to the study will receive 1.25 mg/kg PROMITIL. If no dose-limiting toxicities (DLTs) are recorded by day 43 of the study, the second cohort of 6 patients will begin treatment at a dose level of 1.5 mg/kg PROMITIL. Upon completion of two treatment cycles, with ≤1 incident of DLTs in Cohort 2, a third cohort (n=6) will be recruited and will be treated with a dose level of 1.8 mg/kg.
15877481|NCT03823989|Radiation|EBR|A 10-fraction course of EBR (3 Gy/fraction), initiated 1-3 days after the first PROMITIL dose and completed within a 2-week period.
15877482|NCT03823976|Other|Types of the dental procedures in general anaesthesia|Analysis of the mean number of preventive, prophylactic, therapeutic and rehabilitation procedures
15877483|NCT03823963|Combination Product|Mepilex® Border dressing|Soft silicone self-adherent dressing (5-layers)
15877484|NCT03823963|Other|Standard care|The control group will receive pressure ulcer prevention standard care
15877485|NCT03823950|Drug|Granulocyte Colony-Stimulating Factor|Begin G-CSF 72 hours following chemotherapy
15877486|NCT03823937|Other|Sniffin' Sticks test and Taste strips|"Sniffin' Sticks test (Burghardt®, Wedel, Germany) is a psychophysical test. It allows semi-objective assessment of the patient's olfactory performance by means of 3 subtests: threshold test, identification test and discrimination test. The Sniffin' Sticks Olfactory Test Kits contain pen like bodies as, for example, in pens used to write on flipcharts or whiteboards.These pen-like bodies, however, contain a fibre stick which is filled with scents. For testing, the cap should be removed so the patient can smell on the tip of the pen.
~The taste strips are a validated examination procedure to investigate the taste ability. When testing the whole mouth taste ability, the taste strips are applied by putting them on the tongue and closing the mouth."
15877487|NCT03823924|Procedure|Bone mineral density (BMD)|"The bone mineral density (BMD) performed by DXA, which will allow the analysis of bone density (mg / cm²) at the lumbar spine (BMD L1 to L4) and the total hip (non-dominant).
~This examination will also allow an analysis of the body composition at the same time (lean mass, fat mass and bone mass for the whole body)."
15877488|NCT03823911|Drug|Elbasvir / Grazoprevir Oral Tablet [Zepatier]|All approved direct-acting antivirals for hepatitis C will be used as the intervention.
15877489|NCT03823911|Procedure|Cardiac MRI|Cardiac MRI to assess for myocardial function and fibrosis
15877490|NCT03823898|Behavioral|Supervised exercise|Two supervised exercise sessions per week from months 4 to 16
15877491|NCT03823898|Behavioral|Lifestyle intervention from baseline to 4 months|Lifestyle intervention from baseline to 4 months
15877492|NCT03823898|Behavioral|Monthly behavioral sessions|Monthly behavioral sessions consisted of lifestyle interactive sessions will take place monthly and covered and followed contents that were addressed during the first 4 months of the study
15877493|NCT03823885|Other|e-cigarette|use e-cig for 30 minutes
15877494|NCT03823885|Other|empty (-cigarette sham control)|use empty e-cig (sham control)
15877495|NCT03823872|Other|Time restricted feeding|Time restricted feeding= consume food only from 12:00pm-8:00pm
15877496|NCT03823872|Other|Normal feeding|Normal feeding= consume food per normal schedule
15877497|NCT03823859|Diagnostic Test|Indirect calorimetry|Resting energy expenditure
15877498|NCT03823859|Diagnostic Test|Dual energy X-ray Absorptiometry (DXA)|Body composition
15877499|NCT03823859|Diagnostic Test|Blood sampling|fT4, fT3, TSH, HDL, LDL, triglycerides, cholesterol, HbA1c, Glucose Thyroid panel
15877500|NCT03823846|Drug|Routine Dezocine injection|Dezocine 10mg were intramuscular injected at 8:00am, 4:00pm and 12:00pm.
15877501|NCT03823846|Drug|Adjusted Dezocine injection|Dezocine 10mg were intramuscular injected at at 6:00am, 2:00pm and 10:00pm.
15877502|NCT03823846|Drug|Routine Dynastat or Flurbiprofen Axetil jinjection|Dynastat 40mg or Flurbiprofen Axetil 50mg were administrated intravenously at 9:00am, 4:00pm and 12:00pm.
15877503|NCT03823846|Drug|Adjusted Dynastat or Flurbiprofen Axetil jinjection|Dynastat 40mg or Flurbiprofen Axetil 50mg were administrated intravenously at at 6:00am, 2:00pm and 10:00pm.
15877504|NCT03823846|Other|postoperative rehabilitation|Rehabilitation was conducted at 8:00am and 2:00pm.
15877505|NCT03823846|Drug|normal analgesia pump administration|Dose of analgesia pump was added if needed.
15877506|NCT03823846|Drug|adjusted analgesia pump administration|Dose of analgesia pump was added if needed. Add one dose of analgesia pump 10 minutes before rehabilitation.
15877507|NCT03823820|Other|Bioimpedance Analyser|Bio-electrical impedance analysis (BIA) measures whole body (or regional) impedance by means of an electric current transmitted at different frequencies.
15877508|NCT03823807|Drug|SH-1028|Oral,100mg or 200mg ,QD, fasted
15877509|NCT03823794|Other|No intervention|Observational analysis of usual care only
15877510|NCT03823781|Drug|Milrinone|The study intervention is an intravenous infusion of milrinone or placebo.
15877511|NCT03823781|Drug|Normal saline|The study intervention is an intravenous infusion of milrinone or placebo.
15877512|NCT03823768|Drug|Envarsus|Subjects in this group will take Envarsus daily for 6 months of treatment (goal 24 hour trough: 3-10 ng/mL) +/- adjunctive agent and prednisone.
15877513|NCT03823768|Drug|Tacrolimus Immediate release|Subjects in this group will take Tacrolimus immediate release for 6 months of treatment (goal 12 hour trough: 3-10 ng/mL) +/- adjunctive agent and prednisone.
15877514|NCT03823742|Other|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT): Study treatments for the child will be conducted by a psychologist or master's level therapist. Therapists will be provided with a standardized protocol for each session . CBT treatment will be given over 1 hour, once a week, for three weeks .
15877515|NCT03823742|Other|Low FODMAP Diet|Low FODMAP Diet Condition: Subjects will receive detailed education by a dietitian about following a low FODMAP diet including a definition of FODMAPs, how to select low FODMAP foods, and how to read food labels to identify FODMAPS. The dietitian will contact the family for 1 hour, once a week, for three weeks.
15877516|NCT03823729|Device|Elosan Cabin|The Elosan Cabin is a closed, electrically insulated, biocompatible cabin for the short-term application of electrostatic high voltage. Patients assigned to the Group A will have 8 sessions in the Elosan cabin, with an interval of 3 to 4 days between sessions.
15877517|NCT03823703|Drug|Miricorilant|Miricorilant 900 mg for oral dosing
15877518|NCT03823703|Drug|Miricorilant|Miricorilant 600 mg for oral dosing
15877519|NCT03823703|Drug|Placebo|Placebo tablets for oral dosing
15877520|NCT03823690|Device|EUS-guided gastrojejunstomy|As listed in the arms description
15877521|NCT03823690|Device|The pyloro-duodenal stent|As listed in the arms description
15877522|NCT03823677|Procedure|Hypoxia|hypoxia
15877523|NCT03823664|Diagnostic Test|Cardiorespiratory Fitness|Maximal symptom limited cardiopulmonary exercise test used assessment of cardiorespiratory fitness. For pulmonary function spirometry test and maximal respiratory pressures assessed.
15877585|NCT03823248|Drug|Folic Acid Tablet simulation|oral administration of folic acid simulation tablets half a hour after meal for 5 mg each time for 3 times a day.
15877586|NCT03823235|Other|Human embryo culture|humidifed or dry incubator
15877587|NCT03823222|Dietary Supplement|Duckweed protein|20 grams isolated protein
15877524|NCT03823651|Behavioral|Interval training|Patients will be asked to complete up to 3 x 30-minute structured high intensity interval training aerobic exercise sessions/week. For the first session, patients will come to the Duke Center for Living for in person evaluation and training. After the initial training session in person, a subsequent training session will take place at the patient's home via iPad/iPhone videoconference using a device provided to the patient to provide additional support and the opportunity to answer questions. Subsequent sessions will be done independently by patients, but study staff will be available via iPad/iPhone if questions arise.
15877525|NCT03823651|Behavioral|Psychiatric consult|Subjects who score below threshold on the PHQ2/PHQ9, PC-PTSD/PCL-5, PROMIS-Depression and/or PROMIS-Anxiety assessments will be referred to a psychiatrist for follow up.
15877526|NCT03823651|Behavioral|Nutrition/diet evaluation|PG-SGA, ASA24, food group tracking Assessments and Vit D, Vit A, albumin, prealbumin, lipids, A1c levels will be used to provide weekly feedback for one month
15877527|NCT03823651|Behavioral|Referral to Social Worker|Subjects who score below threshold on the PROMIS-Emotional Support and/or PROMIS-Social Isolation assessments will be referred to a social worker for follow up
15877528|NCT03823638|Dietary Supplement|Oral D-Mannitol of Placebo|Gradually increased doses of oral D-Mannitol of Placebo (Dextrose monohydrate)
15877529|NCT03823625|Drug|Nivolumab plus Ipilimumab|Nivolumab will be administered at the standard dose of 360 mg every 3 weeks. Ipilimumab will be administered at the dose of 1 mg/kg every 6 weeks.
15877530|NCT03823625|Drug|Platinum-based chemotherapy plus Nivolumab|"Nivolumab will be administered at the standard dose of 360 mg every 3 weeks.
~Platinum-based chemotherapy will be chosen by the investigator among the following regimens:
~Cisplatin 80 mg/mq iv day 1 and Gemcitabine 1250 mg/mq iv days 1 and 8 every 21 days;
~Carboplatin AUC 5 iv day 1 and Gemcitabine 1000 mg/mq iv days 1 and 8 iv every 21 days;
~Carboplatin AUC 6 iv day 1 and paclitaxel 200 mg/mq iv day 1 every 21 days."
15877531|NCT03823612|Drug|Clinpro Tooth Creme|The participant will be instructed to Place a pea-sized amount of Clinpro Tooth Crème on a soft bristled toothbrush and brush teeth for at least two minutes then after brushing the patient will rinse out his mouth with water and spit out. It will be used twice daily at first in the morning and before sleep.
15877532|NCT03823612|Drug|GC tooth mousse|The participant will be instructed to squeeze a small amount of GC Tooth Mousse out onto a clean finger. A cotton tip, swab or custom tray are suitable application methods as it will Applied directly onto his tooth surfaces and leave undisturbed for three minutes then he will be instructed to Spread any residual crème around the mouth with his tongue and hold for a further one to two minutes then the participant will expectorate thoroughly and if possible he should avoid rinsing. Any GC Tooth Mousse remaining in the mouth can be left to gradually dissipate. The participant will be instructed to avoid eating or drinking for 30 minutes following application.
15877533|NCT03823599|Behavioral|Mobile chat-based instant messages|Subjects in the active arm study will receive 5-minute face-to-face ABI, alcohol leaflet from Department of Health (DH) plus continuous interactive chat-based intervention for 1 month as an extension of alcohol brief intervention at baseline
15877534|NCT03823599|Behavioral|Alcohol brief intervention|The Control group will receive face-to-face ABI plus an alcohol leaflet from DH.
15877535|NCT03823586|Diagnostic Test|Questionnaire AQUA©, pediatric version|A version of AQUA© recently adapted and pretested in young athletes. It is a self-administered questionnaire composed of 25 items includes items about type, duration and intensity of training sessions, allergic status, habits of children (supplements and drugs intake) and their parents (smoking), presence and burden of infections.
15877536|NCT03823573|Behavioral|Walk within 24 hours|Patients will start walking on different timings. Patients on the rapid recovery protocol won't be using drains.
15877537|NCT03823560|Device|Celegyn®|Medical device Celegyn® presents itself as a cream.
15877538|NCT03823560|Device|Matching placebo|IP placebo presents itself as a cream.
15877539|NCT03823534|Drug|Ketorolac|IV Ketorolac to be given over the course of the first 24 hours after surgery. See arm/group description for further details.
15877540|NCT03823534|Drug|Normal saline|An IV normal saline placebo prepared by the hospital pharmacy.
15877541|NCT03823534|Drug|Acetaminophen|acetaminophen 500 mg PO Q4 hours PRN for mild pain
15877542|NCT03823534|Drug|Oxycodone Acetaminophen|oxycodone-acetaminophen 5-325 mg PO Q4 hours PRN for moderate to severe pain
15877543|NCT03823534|Drug|Morphine|morphine IV PRN (or other opioid) for severe breakthrough pain
15877544|NCT03823534|Drug|Hydrocodone/Acetaminophen|At discharge, patients will be prescribed 1-2 hydrocodone-acetaminophen 5-325 mg Q4 hours. Those with preexisting liver disease will be prescribed the equivalent in oxycodone.
15877545|NCT03823534|Drug|Oxycodone|Upon discharge, patients will be prescribed the equivalent of 1-2 hydrocodone 5mg Q4 hours upon should they have preexisting liver disease and are unable to consume acetaminophen.
15877547|NCT03823508|Device|anodal tDCS|Patients will receive anodal tDCS during 20 minutes preceded and followed by a behavioral assessment (Coma Recovery Scale Revised) and a high density EEG. The anode will be placed over F3 in order to stimulate the left dorsolateral prefrontal cortex and the cathode over the right supraorbital area.
15877548|NCT03823508|Device|sham tDCS|Identical to anodal tDCS, except that the stimulation will be stopped after 15 seconds.
15877549|NCT03823495|Other|12-week PAP|It is a non-drug intervention, using exercises to reduce elderlies chronic pain.
15877550|NCT03823482|Drug|Lidocaine|Administration of lidocaine 2% 4 mg/kg administered as regional anesthesia of the scalp prior to Mayfield frame placement and lidocaine 1% 40 mg topically to the throat prior to direct laryngoscopy and endotracheal intubation.
15877551|NCT03823469|Behavioral|CCTP|Twelve weekly one-on-one 30-minute tele-sessions through video conference. At the first session, subjects identify their vision regarding home cooking and 3-month goals. During each subsequent meeting, subjects will review their progress towards reaching the prior week's culinary goals and identify goals for the coming week, using a self-discovery process. When patients detect a new culinary skill that is necessary for their progress, s/he will either be taught through discussions or referred to active learning from a Culinary Resource Center.
15877552|NCT03823469|Behavioral|Nutritional counseling|Two 30-minute nutritional counseling sessions
15877588|NCT03823222|Dietary Supplement|Whey protein|20 grams isolated protein
15877553|NCT03823456|Other|Self-acupressure|We teach participants how to using self-acupressure to manage insomnia, depression, and anxiety. Six acupoints are included in our acupressure protocol which are Baihui, Yintang, Fengchi, Neiguan, Shenmen, and Taichong. Participants are requested to stimulate each acupoint in 3 minutes once a day (at night time before going to bed) in 28 days (4 weeks). During the four weeks treatment, participants will receive a weekly phone call follow up to remind them practice self-acupressure at home. Participant also receives a patient leaflet with 10 tips heil to manage insomnia, depression, and anxiety. These tips include some basic sleep hygiene rules and tips to manage anxiety and depression adapted from Anxiety and Depression Association of American.
15877554|NCT03823456|Other|Sham Self-acupressure|We using a sham acupressure protocol to teach participants in this group. Six sham acupoints are included in the protocol. The sham acupoints are located 2-5cm away from the true acupoints. Participants are requested to stimulate each sham acupoint in 3 minutes once a day (at night time before going to bed) in 28 days (4 weeks). During the four weeks treatment, participants will receive a weekly phone call follow up to remind them practice self-acupressure at home. Participant also receives a patient leaflet with 10 tips heil to manage insomnia, depression, and anxiety. These tips include some basic sleep hygiene rules and tips to manage anxiety and depression adapted from the Anxiety and Depression Association of American.
15877555|NCT03823430|Diagnostic Test|Pupillometry|Pupillar diameter variation measurement
15877556|NCT03823417|Drug|Tranexamic Acid|Intravenous TXA given as a loading dose over 15 minutes of 30 mg/kg bolus (within an hour prior to surgical incision) and 10 mg/kg/hr infusion for the duration of the surgery
15877557|NCT03823417|Drug|Normal saline|Normal saline infusion
15877558|NCT03823404|Drug|COR388 capsule|bid
15877559|NCT03823404|Drug|Placebo capsule|bid
15877560|NCT03823391|Drug|ABBV-3373|ABBV-3373 is administered as intravenous (IV) infusion
15877561|NCT03823391|Drug|Placebo for ABBV-3373|Placebo for ABBV-3373 is administered as IV infusion
15877562|NCT03823391|Drug|Adalimumab|Adalimumab is administered as subcutaneous (SC) injection
15877563|NCT03823391|Drug|Placebo for adalimumab|Placebo for adalimumab is administered as subcutaneous (SC) injection
15877564|NCT03823378|Drug|Elsubrutinib|Elsubrutinib capsule will be administered orally.
15877565|NCT03823378|Drug|Upadacitinib|Upadacitinib tablet will be administered orally.
15877566|NCT03823378|Drug|Placebo for elsubrutinib|Placebo capsule for elsubrutinib will be administered orally.
15877567|NCT03823378|Drug|Placebo for upadacitinib|Upadacitinib placebo tablet will be administered orally.
15877568|NCT03823365|Biological|Blinatumomab Expanded T-cells (BET)|"Two to five days after the last chemotherapy infusion, BET will be administered. An accelerated titration dose escalation design will be used. During dose escalation, up to four dose levels (see table) will be evaluated or until (Maximum Tolerated Dose) MTD is reached.
~Dose level BET dose(Counted on CD3+ cells)
~(starting dose) 3.0 x 109
~6.0 x 109
~9.0 x 109
~12.0 x 109"
15877569|NCT03823352|Drug|Antroquinonol|Antroquinonol: 100 mg and corn oil 100 mg encapsulated in a gelatin capsule administered orally. Dose will be selected(200mg TID or 300mg TID with SOC) after phase I, then follow up the best dose for 40 Patients for the efficacy.
15877570|NCT03823339|Drug|Insulin degludec/liraglutide|Patients will be treated with Insulin degludec/liraglutide (Xultophy®) at the treating physician's discretion and independent from the decision to include the patient in the study.
15877571|NCT03823313|Behavioral|SCAI (Spiritual Care Assessment and Intervention)|4 sessions completed with an IU Health chaplain using a framework of questions called the Spiritual Care Assessment And Intervention tool. The weekly sessions will focus on one of the 4 areas of spiritual experience (meaning and purpose, relationships, transcendence and peace, self-worth and identity)
15877578|NCT03823274|Drug|Aspirin, Clopidogrel|to evaluate the relationship of stroke recurrence and anti-platelet resistance in ischemic stroke patients receiving aspirin and clopidogrel
15877579|NCT03823261|Behavioral|Cognitive Behavioral Therapy|HIV(+) Koreans with depressive symptoms or poor adherence are our target population. This study is a hospital based implementation research. Most PLWH in South Korea regularly visit ID clinics in tertiary hospitals. The ID clinic of study site can reach the target population. In the clinic, the levels of adherence are routinely measured, and depressive symptoms will be asked with key questions We plan to enroll 50 subjects for CBT-AD intervention. In addition, 2 nurses who providing CBT service, and 6 health care workers will be enrolled for survey for providers and healthcare workers.
15877580|NCT03823248|Drug|MoLuoDan|oral administration of Moluodan concentrated pills with warm water before meal for 8 pills each time for three times a day
15877581|NCT03823248|Drug|Sanchi powder|oral administration of Sanchi powder mixing with warm water before meal for 3g each time for twice a day
15877582|NCT03823248|Drug|Folic Acid Tablet|oral administration of folic acid tablets half an hour after meal for 5 mg each time for 3 times a day.
15877583|NCT03823248|Drug|MoLuoDan simulation|oral administration of Moluodan simulation medicine with warm water before meal for 8 pills each time for three times a day
15877584|NCT03823248|Drug|Sanchi powder simulation|oral administration of Sanchi powder simulation medicine mixing with warm water before meal for 3g each time for twice a day
15877589|NCT03823209|Behavioral|Social Network|Leaders of social networks will be statistically determined. Over 5 small-group training sessions, these leaders will be trained to communicate to their social network members accurate information about PrEP and its availability; correct PrEP misconceptions and negative stereotypes; endorse PrEP use and its benefits; and strengthen friends' attitudes, intentions, perceived peer norms, and self-efficacy regarding PrEP as a personal HIV protective strategy.
15877590|NCT03823209|Behavioral|Brief HIV Prevention Counseling|Participants will receive brief (15-minute) counseling on how to prevent HIV infection.
15877591|NCT03823196|Dietary Supplement|Verum900|Sinetrol® Xpur is a blend of polyphenol-rich extracts from grapefruit, guarana seed, sweet orange and blood orange. Daily dosage is 900 mg for 16 weeks
15877592|NCT03823196|Dietary Supplement|Verum1800|Sinetrol® Xpur is a blend of polyphenol-rich extracts from grapefruit, guarana seed, sweet orange and blood orange. Daily dosage is 1800 mg for 16 weeks
15877593|NCT03823183|Behavioral|Cognitive training|Group-based cognitive training on iPads with commercially available video games (Lumosity) designed to enhance executive control, memory functions and processing speed. Difficulty will be automatically adjusted to the performance level of the participant. Participants will train for 40 min 2 days/wk over 3 months.
15877594|NCT03823183|Behavioral|Physical training|Group-based fitness program (senior-friendly adaption of BodyAttack) that combines aerobic, strength and coordination training to a music soundtrack. Participants will train for 40 min, 2 days/wk over 3 months.
15877595|NCT03823183|Behavioral|Cognitive control|Group-based cognitive control activity consisting of playing on iPads non-cognitively demanding video games during 40 min 2 days/wk over 3 months and exercises based on relaxation and stretching for 40 min, 2 days/wk over 3 months.
15877596|NCT03823183|Behavioral|Physical control|Group-based exercises program (based on relaxation and stretching) for 40 min, 2 days/wk over 3 months.
15877597|NCT03823170|Radiation|Laser therapy|The low-power, infrared (808nm wavelength) diode laser with a power of 100mW will be used. The mode of irradiation is punctual, in contact and perpendicular to the dental surface. Three points on the crown of multiradicular teeth (mesial and distal of the cervical region and central part of the tooth lesion) and two points on the crown of unirradicular teeth (central point of the cervical region and central part of the tooth lesion) will be irradiated for 10s per point , 1J per point, with a 72-hour interval between treatment sessions. The distance between the irradiation points will be about 2 mm. The tip of the laser equipment will be positioned perpendicular to the application site.
15877598|NCT03823170|Procedure|Fluorotherapy|The treatment will be carried out with the application of fluoride varnish, with the aid of a microbrush. After the application, water will be dripped onto the applied varnish in order to promote its drying. Fluorotherapy will be performed once a week, totaling 4 sessions.
15877599|NCT03823170|Combination Product|Laser therapy and Fluorotherapy|This group will be treated first with the laser (same specifications as Laser therapy), followed by application of fluoride varnish (same specifications as Fluorotherapy).
15877600|NCT03823157|Behavioral|Tai Chi|mind-body exercise
15877601|NCT03823144|Device|Human Intravital Microscopy|Intravital microscopy (IVM) allows real-time, direct visualization of microscopic blood vessels and calculation of blood flow.
15877602|NCT03823131|Device|Electroporation|Intratumoral
15877603|NCT03823131|Drug|Epacadostat|Given PO
15877604|NCT03823131|Drug|Pembrolizumab|Given IV
15877605|NCT03823118|Drug|S1/Anlotinib|Anlotinib 12mg qd, day 1 to day 14 followed by 7 days off treatment in a 21-day cycle until maximum 6 cycles； S1 60mg bid, day 1 to day 14 followed by 7 days off treatment in a 21-day cycle until it can not tolerate, or disease progression.
15877606|NCT03823105|Device|OHR Tracker and PulseWatch|Category A (ClinO). Medical study with CE-marked medical devices to photoplethysmographic measure heart rate, heart rate variability, and pulse wave and accelerometric data
15877607|NCT03823092|Diagnostic Test|polarization sensitivity|test of polarization vision as described in Study Description
15877608|NCT03823079|Drug|rhTPO|rhTPO 300u/kg, subcutaneous injection, qd
15877609|NCT03823079|Drug|irinotecan|80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7)
15877610|NCT03823079|Drug|Raltitrexed|3mg/m2 q3w
15877611|NCT03823079|Radiation|radiotherapy|in the use of intensity-modulated radiotherapy (IMRT) technology, the dose is judged according to the tumor site and radiotherapy purpose.
15877612|NCT03823079|Drug|rhIL-11|rhIL-11 50ug/kg, subcutaneous injection, qd
15877613|NCT03823066|Device|Coach Pepper|Robot Peppers's height is 1.20 meters and it weighs 28 kilograms. Pepper will be called Coach Pepper, because it is connected, via web interfaces, with a theratainment app including cognitive and physical training
15877614|NCT03823053|Other|Home Based Traditional Scoliosis Exercise|Program will include posture exercises, strengthening exercises of interscapular muscle and limb, diaphragmatic breathing exercises and stretching exercises for lumbar extensor, hip flexor, hamstring, pectoral muscles. Exercises will be applied 1 sets of 10 repetitions and once a day.
15877615|NCT03823053|Other|Home Based Core Stabilization Training|Program will include posture exercises, strengthening exercises of interscapular muscle and limb, diaphragmatic breathing exercises and stretching exercises for lumbar extensor, hip flexor, hamstring, pectoral muscles. In addition, the training group received core stabilization exercises for multifidus, transversus abdominis, diaphragm,erector spines, rectus abdominis, internal and external obliques, quadratus lumborum, gluteus maximus, and pelvic floor muscles.Exercises will be applied 1 sets of 10 repetitions and once a day.
15877616|NCT03823040|Drug|Oxiconazole Nitrate Cream 1%|Tinox® group was treated with oxiconazole nitrate cream 1 % . Treatment was performed by rubbing the cream twice daily for two/ four weeks according to different types of tinea.
15877617|NCT03823040|Drug|Oxiconazole nitrate SLNs loaded gel.|Oxiconazole nitrate SLNs loaded gel group was treated with oxiconazole nitrate SLNs loaded gel.Treatment was performed by rubbing the gel twice daily for two/ four weeks according to different types of tinea.
15877618|NCT03823027|Device|SiPore15™|SiPore15™ is a taste- and odourless white powder, consisting of precisely engineered micrometre sized synthetic amorphous silicon dioxide. The device is made of pure silicon dioxide, SiO2, which has the CAS Number: 112926-00-8 and EC List number: 601-214-2.
15877619|NCT03823014|Device|Elator|Measurement for device, use of device
15877689|NCT03822546|Other|myblu 40 mg nicotine salt|E-cigarette used for 10 inhalations every 30 seconds
15888867|NCT03736616|Drug|Melphalan|Chemotherapy
15877620|NCT03823001|Diagnostic Test|virtual biopsy (VB) monitoring protocol|"PSA bi-annually or more often according to the discretion of the urologist.
~Annual DRE.
~Visit with the urologist bi-annually.
~Multi-parametric MRI (mpMRI) every year for 3 years.
~Transrectal ultrasound (TRUS) biopsy at the end of the 3rd year."
15877621|NCT03822988|Other|no intervention, only complete a survey|we will ask patients to answer to a survey
15877622|NCT03822975|Drug|Bivalirudin|Bivaliruding 0.75 mg/kg intravenous bolus loading dose, and immediately followed by intravenous infusion of 1.75 mg/kg/h until 2-4 hours after PCI. It is recommended that ACT be monitored 5 minutes after the first administration, and if ACT is <225 s (Hemotec method), intravenous injection of 0.35 mg/kg of bivalirudin should be administered, and the ACT re-checked to ensure it is >225 seconds.
15877623|NCT03822975|Drug|unfractionated Heparin|Heparin 70 U/kg is started before coronary angiography. ACT is monitored 5 min after the first administration, and if the ACT <225 s (Hemotec method), an intravenous injection of 1000 U of heparin is administered, and the ACT re-checked to ensure it is >225 seconds.
15877624|NCT03822962|Drug|Ibuprofen 600Mg Tablet|ibuprofen 600 mg by mouth every 8 hours scheduled in addition to standard tylenol regimen.
15877625|NCT03822962|Other|"Standard Regimen | Tylenol"|Tylenol 1000 mg by mouth every 6 hours scheduled and a rescue prescription of oxycodone 5 mg tablets by mouth every 6 hours as needed for pain. Ten total oxycodone tablets will be prescribed.
15877626|NCT03822949|Device|Day Light|Patients are exposed to daylight for up to 10 days prior to surgery
15877627|NCT03822949|Device|Placebo light|Patients are exposed to placebo light for up to 10 days prior to surgery
15877628|NCT03822936|Drug|Preoperative chemotherapy|Preoperative chemotherapy, carbon ion therapy, surgery
15877629|NCT03822936|Radiation|Preoperative radiotherapy|Preoperative chemotherapy, carbon ion therapy, surgery
15877630|NCT03822923|Other|Experimental group|Neurodynamics with conventional treatment. Intervention will be applied for 6 weeks (10 reps per set, 1 set per day, 3 days per week) for 30 minutes
15877631|NCT03822923|Other|Control group|Conventional treatment
15877632|NCT03822910|Diagnostic Test|Pattern Separation Paradigm|Will be used to investigate dentate gyrus (DG) and hippocampal CA3 subfield as reflected by the difference in brain activation in response to same as previously seen (OLD) vs similar to previously seen (SIM) objects in first episode (FEP) subjects before and after treatment.
15877633|NCT03822910|Diagnostic Test|Sequential Associative Mismatch Paradigm|used to reflect activation of CA1 in response to mismatching information compared to memory of the stimulus in FEP subjects before and after antipsychotic treatment and in matched Healthy Control (HC).
15877634|NCT03822910|Diagnostic Test|Encoding Plasticity Paradigm|Used to evaluate plasticity of hippocampal Intrinsic Functional Connectivity (IFC) in response to memory consolidation in FEP subjects before and after antipsychotic treatment and in matched HC.
15877635|NCT03822897|Radiation|Radiation|"35 fractions, 5/wk, 7 wks 70Gy/56Gy, or
~35 fractions, 6/wk, 6 wks, 70Gy/56Gy, or
~35 fractions, 5/wk, 7 wks OR 6/wk, 6 wks 70Gy/56Gy"
15877636|NCT03822897|Drug|Cisplatin|100 mg/m2 on day 1, 22, and 43 or 40 mg/m2 /wk for 7 wks
15877637|NCT03822884|Drug|Epoetin Alfa 40000 UNT/ML|40.000 UI subcutaneous single dose
15877638|NCT03822871|Drug|CTT1403|Escalating doses of 0.75 GBq - 13.5 GBq will be administered in an accelerated to traditional 3+3 dose escalation design. After escalation, 10 additional patients will be enrolled into a dose expansion cohort. Patients meeting eligibility criteria with demonstrated cessation of disease progression will be offered a second dose of the study drug, CTT1403.
15877639|NCT03822871|Drug|CTT1057|Patients will be screened with CTT1057 or 68Ga-PSMA-11 PSMA PET to demonstrate presence of at least 3 PSMA avid lesions that can be targeted by the study drug, CTT1403. 5-7 weeks after administration of study drug, patients will be evaluated a second time with PSMA PET imaging using with either CTT1057 or 68Ga-PSMA-11 to assess potential efficacy of CTT1403.
15877640|NCT03822871|Drug|68Ga-PSMA-11|Patients will be screened with CTT1057 or 68Ga-PSMA-11 PSMA PET to demonstrate presence of at least 3 PSMA avid lesions that can be targeted by the study drug, CTT1403. 5-7 weeks after administration of study drug, patients will be evaluated a second time with PSMA PET imaging using with either CTT1057 or 68Ga-PSMA-11 to assess potential efficacy of CTT1403.
15877641|NCT03822858|Drug|Intrathecal MSC-NP injection|"Between 5 to 10 million MSC-NPs will be administered intrathecally in each dose.
~10 million cells is the maximum dose. Treatment will consist of 3-5 doses spaced 3 months apart."
15877642|NCT03822845|Drug|Ga-68 PSMA-HBED-CC PET|Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
15877643|NCT03822832|Drug|BI 655130|Solution for infusion
15877644|NCT03822832|Drug|Placebo|Solution for infusion
15877645|NCT03822819|Dietary Supplement|probiotic cocktail capsules|Daily uptake of probiotic cocktail for three weeks
15877646|NCT03822819|Dietary Supplement|placebo capsules|Daily uptake of placebo capsule for three weeks
15877647|NCT03822806|Other|Physical Exercise in addition to Patching|Patch for 2 hours a day, and exercise for the first 30 minutes of those 2 hours using the video game
15877648|NCT03822793|Drug|Placebo|Patient will receive a perfusion of NaCl (sodium chloride 9%; placebo) intravenous over 10 minutes just before surgery.
15877649|NCT03822793|Drug|Group 1: perfusion of 500 mg Exacyl|Patient will receive a perfusion of 500mg Exacyl (tranexamic acid) intravenous (IV) over 10 minutes just before surgery.
15877650|NCT03822793|Drug|Group 2: perfusion of 1000 mg Exacyl|Patient will receive a perfusion of 1000mg Exacyl (tranexamic acid) intravenous (IV) over 10 minutes just before surgery.
15877651|NCT03822793|Drug|Group 3: perfusion of 1500 mg Exacyl|Patient will receive a perfusion of 1500mg Exacyl (tranexamic acid) intravenous (IV) over 10 minutes just before surgery.
15877652|NCT03822793|Drug|Group 4: perfusion of 3000 mg Exacyl|Patient will receive a perfusion of 3000mg Exacyl (tranexamic acid) intravenous (IV) over 10 minutes just before surgery.
15877653|NCT03822780|Drug|Hydroxychloroquin|Hydroxychloroquine Sulfate (HCQ, Quensyl) in a loading dose of 10 mg/kg*d, p.o., bid. After the illness gradually alleviate to maintain dose between 5mg/kg*d to 10mg/kg*d, p.o., bid ; the maximum daily dose is 400mg.
15877690|NCT03822546|Other|blu PRO 48 mg nicotine salt|E-cigarette used for 10 inhalations every 30 seconds
15877691|NCT03822533|Other|Physiotherapist as primary assessor|Physiotherapist diagnose and treat the patient.
15877654|NCT03822767|Biological|sIPV-sIPV-bOPV vaccination schedule|Two intramuscular injections of the investigational vaccine (0.5 ml) on Day 0 and Day 30 respectively; Single dose of bOPV (0.1 ml) on Day 60. The investigational Sabin strain inactivated poliovirus vaccine (Vero cell)(sIPV) was manufactured by Sinovac Biotech Co., Ltd . The poliovirus (Live) vaccine type I & type III (Human Diploid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd.
15877655|NCT03822767|Biological|wIPV-wIPV-bOPV vaccination schedule|Two intramuscular injections of the control vaccine(0.5 ml) on Day 0 and Day 30 respectively; Single dose of bOPV (0.1 ml) on Day 60. The investigational Sabin strain inactivated poliovirus vaccine (Vero cell)(sIPV) was manufactured by SANOFI PASTEUR S.A. The poliovirus (Live) vaccine type I & type III (Human Diploid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd.
15877656|NCT03822754|Biological|sIPV-bOPV-bOPV vaccination schedule|Single intramuscular injection of the experimental sIPV (0.5 ml) on Day 0, following two doses of bOPV (0.1 ml) on Day 30 and Day 60 respectively. The investigational Sabin strain inactivated poliovirus vaccine (Vero cell)(sIPV) was manufactured by Sinovac Vaccine Technology Co., Ltd. The poliovirus (Live) vaccine type I & type III (Human Dipoid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd.
15877657|NCT03822754|Biological|wIPV-bOPV-bOPV vaccination schedule|Single intramuscular injection of the control wIPV (0.5 ml) on Day 0, following two doses of bOPV (0.1 ml) on Day 30 and Day 60 respectively.The control wild strain inactivated poliovirus vaccine (wIPV) was manufactured by SANOFI PASTEUR S.A. The poliovirus (Live) vaccine type I & type III (Human Dipoid cell) ( bOPV) was manufactured by Beijing Bio-institute Biological Products Co., Ltd.
15877658|NCT03822728|Diagnostic Test|3D-DESS MRI (3 dimensional double echo steady state MRI)|3D-DESS MRI has been reported useful for the intra-parotid facial nerve imaging. It can provide information about the anatomical relationship between the tumor and the facial nerve in the parotid gland.
15877659|NCT03822715|Other|Carbohydrate restricted dietary intervention|Carbohydrate restricted dietary intervention (<20 g carbohydrates/day)
15877660|NCT03822715|Drug|standard of care aromatase inhibitors|standard of care aromatase inhibitors
15877661|NCT03822702|Other|Biofeedback Training|Biofeedback training targeted to goals that are relevant to the handwriting skills for children by using a force acquisitional pen.
15877662|NCT03822702|Other|Motor Training|Motor training targeted to goals that are relevant to the handwriting skills for children by using a personal designed motor training program.
15877663|NCT03822689|Device|Ventilator breathing tube F2220|M: Folding D: 22mm; L: 2.0M
15877664|NCT03822689|Device|Ventilator breathing tube F2216|M: Folding; D: 22mm; L:1.6M
15877665|NCT03822689|Device|Ventilator breathing tube F1520|M: Folding; D: 15mm; L:2.0M
15877666|NCT03822689|Device|Ventilator breathing tube F1516|M: Folding; D: 15mm; L:1.6M
15877667|NCT03822689|Device|Ventilator breathing tube U1016|M: Unfolding; D: 10mm; L:1.6M
15877668|NCT03822689|Device|Ventilator breathing tube U1516|M: Unfolding; D: 15mm; L:1.6M
15877669|NCT03822689|Device|Ventilator breathing tube CA20|M: Co-axis; L:2.0M
15877670|NCT03822689|Device|Ventilator breathing tube CA16|M: Co-axis; L:1.6M
15877671|NCT03822676|Device|Prophylactic pancreatic stent|Prophylactic pancreatic stent before segmental pancreatic surgery
15877672|NCT03822663|Dietary Supplement|Caffeine supplementation|The experimental procedure for each athlete includes an acute CAF supplementation in a different-dose crossover regimen in order to assess whether the dose affects the actual physical capacity and discipline-specific exercise performance (doses: 3.0-, 6.0- and 9.0 mg/kg of body mass, respectively). CAF (pure pharmaceutical caffeine) will be administered in the dissolved form. On testing days, the supplements will be taken 45 min before physical and exercise capacity test session. Between the CAF and PLA or a PLA and CAF treatments, a minimum 7-day washout period will be introduced.
15877673|NCT03822663|Dietary Supplement|Placebo treatment|The experimental procedure for each athlete will include PLA supplementation. Placebo will be administered in the dissolved form. On testing days, the PLA will be taken 45 min before physical and exercise capacity test session. Between the PLA and CAF or a CAF and PLA treatments, a minimum 7-day washout period will be introduced.
15877674|NCT03822637|Drug|n-acetylcystine + albuterol|NAC is a mucolytic drug and Albuterol is a bronchodilator.
15877675|NCT03822637|Drug|0.9% saline + albuterol|Normal saline is a placebo agent and Albuterol is a bronchodilator.
15877676|NCT03822624|Dietary Supplement|Probiotic|Probiotic mixture with three bacterial strains with maltodextrin as a carrier.
15877677|NCT03822624|Other|Placebo|Placebo comparator with maltodextrin as a carrier.
15877678|NCT03822611|Behavioral|Targeted Subsidy|Voucher
15877679|NCT03822598|Behavioral|Teaching Recovery Techniques, TRT|TRT is a , low-threshold, group based, manual driven short term intervention to reduce trauma-related mental health problems. The program is based on principles from trauma-focused cognitive-behavioral therapy
15877680|NCT03822585|Diagnostic Test|CBC, Iron Study, Serum Ferrittin, HPLC,Genitic Study|"high performance liquid chromatography (HPLC) has become the preferred technique, as it can detect most of the clinically significant variants. polymerase chain reaction (PCR)-based procedures detect Commonly occurring mutations of the HBB gene .
~If targeted mutation analysis fails to detect the mutation, scanning or sequence analysis can be used. Sensitivity of both mutation scanning and sequence analysis is 99%."
15877681|NCT03822572|Other|endurance exercise|defined exercise program
15877682|NCT03822572|Other|control|habitual physical activity before the diagnosis
15877683|NCT03822559|Drug|A preservative-free, a clear, colorless sterile aqueous ophthalmic solution containing 0.015mg of tafluprost and 5.0mg of timolol in 1mL|One drop a time, once daily administration of DE-111A eye drops in the affected eye(s) at 8:00 am (±1h) for 3 months.
15877684|NCT03822559|Drug|A preservative-free, a clear, colorless sterile aqueous ophthalmic solution containing 0.015mg of tafluprost in 1mL|One drop a time, once daily administration of preservative-free 0.0015% tafluprost eye drops in the affected eye(s) at 8:00 (±1h) for 3 months.
15877685|NCT03822546|Other|Conventional cigarette|Subject's own conventional cigarette brand smoked with puffs taken at 30 seconds intervals
15877686|NCT03822546|Other|myblu 25 mg freebase|E-cigarette used for 10 inhalations every 30 seconds
15877687|NCT03822546|Other|myblu 16 mg nicotine salt|E-cigarette used for 10 inhalations every 30 seconds
15877688|NCT03822546|Other|myblu 25 mg nicotine salt|E-cigarette used for 10 inhalations every 30 seconds
15877692|NCT03822533|Other|Physician as primary assessor|Physician diagnose and treat the patient.
15877693|NCT03822520|Drug|Celecoxib|Celecoxib 400mg capsule
15877694|NCT03822520|Drug|Moxifloxacin|Moxifloxacin 400mg tablet
15877695|NCT03822520|Other|Water|Pure water 150ml
15877696|NCT03822507|Drug|KHK7580|oral administration
15877697|NCT03822507|Drug|Cinacalcet Hydrochloride|oral administration
15877698|NCT03822494|Radiation|CyberKnife SBRT|Radiation Therapy
15877699|NCT03822481|Behavioral|Mindful Construal Diary|A Mindful Eating Intervention
15877700|NCT03822468|Drug|Ribociclib|Ribociclib will be supplied as 200 mg tablets as individual patient supply packaged bottles taken by mouth.
15877701|NCT03822468|Drug|Letrozole or Anastrozole|Letrozole 2.5 mg by mouth QD continuously or anastrozole 1 mg by mouth QD continuously (investigator choice)
15877702|NCT03822468|Drug|Goserelin|Goserelin 3.6 mg subcutaneously once every 4 weeks (pre-menopausal women only)
15877703|NCT03822455|Drug|OligoG DPI|OligoG Dry Powder for Inhalation
15877704|NCT03822429|Drug|Controlled ovarian stimulation|Hormonal therapy to induce ovulation by multiple ovarian follicles
15877705|NCT03822416|Drug|Nicotine patch|Nicotine patch (dose based on number of cigarettes per day) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use
15877706|NCT03822416|Drug|Nicotine lozenge|Nicotine lozenge (2 or 4 mg if less or greater than 30 minutes to first cigarette in the morning respectively) (4-week, 8-week, or 12-week supply) depending on participant preference and how much they are smoking based on FDA guidelines for use
15877707|NCT03822416|Behavioral|Therapy|In-person meeting at baseline, 6 phone counseling sessions with participants over 8 weeks after initial in-person meeting, possible additional phone counseling (3 phone calls) from 8 weeks to 6 months after initial in-person meeting, and possible text messages when agreed to by participants during the 8 week to 6 month phase
15877708|NCT03822416|Other|Information|Information about smoking and mental illness and referrals to both the QUITPLAN helpline and additional resources in the community
15877709|NCT03822403|Device|EQUIA|Placing glass ionomer restorations, the dentin and enamel of cavities were conditioned with 20% polyacrylic acid for 20 seconds, washed, and briefly dried. Equia Fil was injected into the cavity. Isolation was maintained using cotton rolls and a saliva ejector. After the setting time of 2.5 minutes, the restoration was polished wet using high-speed fine diamonds. When the restoration was briefly dried, Equia Coat was applied and photocured for 20 seconds using a photo-curing light.
15877710|NCT03822403|Device|Gradia Direct Posterior|The enamel and dentin were conditioned with G-Bond adhesive using a microtip applicator, left undisturbed for five to 10 seconds, and then dried thoroughly for five seconds with oil-free air under air pressure, Gradia Direct Posterior resin was applied with the incremental technique (2 mm thick layers) and light-cured for 20 seconds. Finally, the restoration was shaped with finishing diamonds and silicon instruments.
15877711|NCT03822390|Device|CAD-CNN system|The CAD-CNN system will be trained in predicting the histology of diminutive polyps. Before training, the dataset will be split up into a training set and a test set. To ensure a completely independent test and training set there will be no overlap between patients (i.e. if polyps from a patient A is present in the training set it cannot be in the test set as well).
15877712|NCT03822377|Drug|Ticagrelor orodispersible tablets|Ticagrelor loading dose (180 mg) given as two orodispersible tablets (each of 90 mg), to be dispersed in saliva.
15877713|NCT03822377|Drug|Ticagrelor standard tablets|Ticagrelor loading dose (180 mg) given as two standard coated tablets (each of 90 mg) to be swallowed with water.
15877714|NCT03822364|Drug|009-1|Inhaled apomorphine via Staccato aerosol, Dose 1
15877715|NCT03822364|Drug|active comparator|commercially available apomorphine injector
15877716|NCT03822364|Drug|009-0|Inhaled placebo via Staccato device
15877717|NCT03822364|Drug|009-2|Inhaled apomorphine via Staccato aerosol, Dose 2
15877718|NCT03822364|Drug|009-3|Inhaled apomorphine via Staccato aerosol, Dose 3
15877719|NCT03822364|Drug|009-4|Inhaled apomorphine via Staccato aerosol, Dose 4
15877720|NCT03822364|Drug|009-5|Inhaled apomorphine via Staccato aerosol, Dose 5
15877721|NCT03822351|Drug|Durvalumab + Oleclumab|Durvalumab + Oleclumab
15877722|NCT03822351|Drug|Durvalumab|Durvalumab
15877723|NCT03822351|Drug|Durvalumab + Monalizumab|Durvalumab + Monalizumab
15877724|NCT03822338|Procedure|Pneumoperitoneum preconditioning|Pneumoperitoneum preconditioning consists of three cycles of 5 min insufflation and 5 min desufflation, after complete anesthesia and successfully implanting the veress. This process will be induced by pneumoperitoneum machine, and the utilized gas will be carbon dioxide to maintain the intra-abdominal pressure at 15 mmHg. The whole duration will last 30 min.
15877725|NCT03822338|Procedure|Sham-Pneumoperitoneum preconditioning|Sham-Pneumoperitoneum preconditioning consists of three cycles without insufﬂation and subsequent desufﬂation. The whole duration will also last 30 min.
15877726|NCT03822312|Device|DBT-TOBI|The DBT-TOBI scan system is designed to deliver low power laser lights through a person's body tissue and collect data about the light that is transmitted through
15877727|NCT03822312|Device|MRI-TOBI|The MRI-TOBI scan system is designed to deliver low power laser lights through a person's body tissue and collect data about the light that is transmitted through. The MRI scan is completed at the same time as the TOBI scan. Participation in this part of the intervention is optional.
15877728|NCT03822299|Dietary Supplement|healthy feces microbiota|Suspension of healthy feces microbiota in sterile saline solution
15877729|NCT03822286|Other|e-training course|Home care staff received mainly self-study, you can download e-books on your lithography or personal mobile phone reading and learning, with lively animation, sound and video guide home staff Learn the knowledge of demented care. The e-book course sets out the themes of the eight demented care training courses.
15877730|NCT03822286|Other|Support group|A counseling master mix 8~10 resident staff members, through the counselor to lead the symposium to the case home to implement technical guidance and through the set of social network groups to immediately discuss the care and solutions of dementia cases, and hold once a month in gathering, about 40~60 minutes each time.
15877731|NCT03822286|Other|traditional classroom teaching course programs|Home care staff received the traditional demented care traditional classroom teaching course and did not accept any e-training and gathering.
15877732|NCT03822273|Procedure|Traditional acupuncture (TA)|"Procedure: real acupuncture.
~Eight disposable, single use, sterilized, stainless steel needles are inserted at each session, and the bilateral LI4 (Hegu), SJ6 (Zhigou), ST36 (Zusanli) and GB34 (Yanglingquan) are used for acupuncture treatment. The acupuncture needles are to be inserted to a depth of 15-35 mm. All needles are rotated manually at least once at each session to elicit needle sensation (De qi). The needle retention time is 15 min."
15877733|NCT03822273|Procedure|Laser acupuncture (LA)|"Procedure: laser acupuncture.
~Participants allocated to the LA group receive laser acupuncture treatment at the same acupoints used in acupuncture group. The laser acupuncture therapy will be performed with the gallium aluminum arsenide LaserPen (maximal power, 150 mW; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; and Bahr frequencies [B1: 599.5 Hz, B2: 1199 Hz, B3: 2398 Hz, B4: 4776 Hz, B5: 9552 Hz, B6: 19,104 Hz, and B7: 38,208 Hz]; RJ-Laser, Reimers & Janssen GmbH, Waldkirch, Germany). The laser will be applied to each point for 5 seconds, which delivered 0.375 J of energy at each of the acupoints: LI4 (Hegu, B3), SJ6 (Zhigou, B3), ST36 (Zusanli, B2) and GB34 (Yanglingquan, B2)."
15877734|NCT03822273|Procedure|Sham laser acupuncture (SLA)|"Procedure: sham laser acupuncture.
~Subjects in the control group receive sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in the LA group."
15877735|NCT03822260|Diagnostic Test|Bezmialem VAkif Unv. Ethical board|If ıs any trials not convenient to Helsinki Agrement about Human research rules
15877736|NCT03822247|Procedure|Multidisciplinary Recovery Program|"Preoperative care:
~Patient's education
~Providing respiratory training
~Assessment of nutritional status
~Application of compression stockings
~Thromboembolism prophylaxis by low molecular weighted heparin
~Induction of hemodynamic support 12 hours before the surgery
~Oral carbohydrate solution loading until 2 hours before the surgery
~Intraoperative care:
~Maintaining normothermia
~Multimodal prevention of postoperative nausea and vomiting
~Use of spinal anesthesia
~Prevention of excessive blood loss
~Local anesthetic infiltration
~Postoperative care:
~Active pain control
~Early mobilization
~Early onset of oral nutrition
~Early delirium detection
~Application of compression stockings"
15877737|NCT03822234|Procedure|Modified ileal conduit|Modified ileal conduit (Extraperitonealization)
15877738|NCT03822221|Other|MVIC and NMES with hip at 85º and knee at 20º|With hip joint at 85º (seated) and knee at 20º (SK20º), subjects will be submitted to maximal isometric voluntary contractions (15-18 per session) and to contractions evoked by neuromuscular electrical stimulation (15-18 per session).
15877739|NCT03822221|Other|MVIC and NMES with hip at 85º and knee at 60º|With hip joint at 85º (seated) and knee at 60º (SK60º), subjects will be submitted to maximal isometric voluntary contractions (15-18 per session) and to contractions evoked by neuromuscular electrical stimulation (15-18 per session).
15877740|NCT03822221|Other|MVIC and NMES with hip at 0º and knee at 20º|With hip joint at 0º (lying) and knee at 20º (LK20º), subjects will be submitted to maximal isometric voluntary contractions (15-18 per session) and to contractions evoked by neuromuscular electrical stimulation (15-18 per session).
15877741|NCT03822221|Other|MVIC and NMES with hip at 0º and knee at 60º|With hip joint at 0º (lying down) and knee at 60º (LK60º), subjects will be submitted to maximal isometric voluntary contractions (15-18 per session) and to contractions evoked by neuromuscular electrical stimulation (15-18 per session).
15877742|NCT03822208|Biological|AL003|"Single-doses of AL003 in dose-escalating cohorts
~Multiple doses of AL003 in a single cohort"
15877743|NCT03822208|Other|Saline Solution|Saline Solution will be administered as a single infusion for each dose escalation cohort in a ratio of 6 active and 2 placebo and as multiple infusions in the single cohort in a ratio of 10 active and 2 placebo
15877744|NCT03822195|Procedure|Carotid endoarterectomy|Surgical removal of carotid bifurcation plaque and arterial repair (direct suture or patch)
15877745|NCT03822182|Drug|liposomal bupivicaine|"The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:
~Group 1 (Control): 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone Group 2: 15ml 0.5% bupivacaine and 10ml (133mg) of LB (Exparel) and 5.4ml normal saline Group 3: 5ml 0.5% bupivacaine and 10ml LB (Exparel) and 0.4ml (4 mg) dexamethasone and 5ml normal saline"
15877746|NCT03822182|Drug|Dexamethasone|steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard bupivicaine.
15877747|NCT03822169|Dietary Supplement|Choline added as a phospholipid|A shake with 3000 mg choline added as a phospholipid
15877748|NCT03822169|Dietary Supplement|Choline added as a salt|A shake with 3000 mg choline added as a salt
15877749|NCT03822156|Other|Observation of AFB smear/culture|Observation of the patients from group for their AFB smear/culture results
15877750|NCT03822143|Diagnostic Test|Ultrasound|Use of ultrasound device to diagnosis anemia in a fetus
15877751|NCT03822130|Drug|Arterial catheter infusion chemotherapy|Arterial catheter infusion chemotherapy
15877752|NCT03822130|Drug|Sodium Bicarbonate|Arterial catheter infusion Sodium Bicarbonate
15877753|NCT03822130|Drug|Systemic Chemotherapy|Systemic Chemotherapy
15877754|NCT03822130|Drug|Oral Chemotherapy|Oral Chemotherapy
15877755|NCT03822117|Drug|Pemigatinib|Pemigatinib administered orally once daily (QD).
15877756|NCT03822104|Dietary Supplement|Bovine Colostrum|Infants randomized to the intervention group will receive a maximum of 2.8 g bovine colostrum (BC, Biofiber, Gesten, Denmark), as the HMF added to 100 ml of MM and/or DM, when EN has reached a dose of 80-100 ml/kg/d. The infants start with 1 g (0.5 g protein) BC per 100 ml human milk on the first day, increased to 2 g (1.0 g protein) on day 3, and finally 2.8 g (1.4 g protein) on day 5 if the infants only receive DM. The intervention lasts until the infants reach postmenstrual age (PMA) 35+6 weeks or in no-need of fortification due to sufficient growth, whichever comes first.
15877757|NCT03822104|Dietary Supplement|FM85|Infants randomized to the control group will receive a maximum of 4 g PreNAN FM85 (Nestlé, Vevey, Switzerland) as HMF, added to 100 ml MM and/or DM, when EN has reached a dose of 80-100 ml/kg/d. The infants starts with 1 g (0.35 g protein) FM85 per 100 ml human milk on the first day, which will be increased to 3 g (1.05 g protein) on day 3 and finally 4 g (1.4 g protein) on day 5, if the infants only receive DM. The infants will receive FM85 as the HMF as long as additional protein in the milk is needed until discharge.
15877758|NCT03822091|Drug|Terlipressin|"Patients with Type 1 HRS will be given Terlipressin at the dose of 2mg/24 hrs as infusion. After 48 hours of initial monitoring, patients who do not respond to the initial dose of Terlipressin, and randomised into group A and B. Group A patients will receive further higher doses of Terlipressin. The dose of Terlipressin will be increased by 1mg after 24 hrs if:
~the creatinine values decrease by <12.5%
~MAP increase of <10 mmHg
~urine output of <200 ml in 4 hours.
~Maximum terlipressin dose will be given upto 12 mg/day.Albumin will be administered in both arms according to standard protocol at the following dose :
~1st day - Albumin at 1 gram/kg - a maximum dose of 100grams can be given.
~A dose of 20gram/day to 60gram/day in the following days."
15877759|NCT03822091|Drug|Terlipressin and Noradrenaline|"Patients with Type 1 HRS will be given Terlipressin at the dose of 2mg/24 hrs as infusion. After 48 hours of initial monitoring, patients who do not respond to the initial dose of Terlipressin, will be randomised into group A and B. Group B patients will be treated with
~Terlipressin(2mg/24hr infusion- fixed dose) and Noradrenaline, which would be given as a continuous infusion at a starting dose of 0.5 mg/hr. The dose od noradrenaline will be increased every 24 hours in steps of 0.5 mg/hr, the maximum dose being 3 mg/hr IF:
~the creatinine values decrease by <12.5%
~MAP increase of <10 mmHg
~urine output of <200 ml in 4 hours."
15877760|NCT03822078|Drug|Placebo|Administered by subcutaneous injection
15877761|NCT03822078|Biological|Denosumab|Administered by subcutaneous injection
15877762|NCT03822065|Drug|LY03005|80 mg oral tablet single dose
15877763|NCT03822052|Other|Lactated ringers|IV fluid
15877764|NCT03822052|Other|5% dextrose lactated ringers|IV fluid
15877765|NCT03822026|Other|Hyperventilation test|Increase of the alveolar ventilation by a stepwise increase in tidal volumes and respiratory rate until a reduction of end-tidal CO2 of 0.7 kPa is achieved
15877766|NCT03822013|Drug|Miglustat|Treatment with Zavesca regimen based on body surface area as follows: SQRT [Height (cm) × Weight (kg)] / 3600 <1.25 : 200mg TDS 0.88- 1.25: 200mg BID 0.73- 0.88: 100 mg TDS 0.47- 0.73: 100 mg BID <0.47: 100 mg Daily
15877767|NCT03822000|Other|Survival|Elderly patients with fall-induced femoral fracture who were survived.
15877768|NCT03822000|Other|Death|Elderly patients with fall-induced femoral fracture who were dead.
15877769|NCT03821987|Drug|Fludarabine|Patients enrolled in this study would receive Bu (IV)0.8mg/kg Q6hx2d,Fludarabine 30mg/m2x5d ,CTX (cyclophosphamide) 25mg/kg/dx4d,rATG (thymoglobulin,Sang Stat,France) 2.5mg/kg/dx4d.
15877770|NCT03821974|Procedure|wet suction technique|"For the wet suction technique, after removing the stylet, the needle was flushed with 2 mL of saline solution to replace the column of air with saline solution. A 10-mL suction syringe, loaded to 5ml negative pressure, was attached in a locked position to the needle after flushing the needle with saline solution. The needle is moved back and forth 20-30 times by applying negative pressure suction within the lesion. Afterwards, the needle is withdrawn from the lesion."
15877771|NCT03821974|Procedure|dry suction technique|"For the dry suction technique, after locating by EUS, the stylet was removed from the needle before performing FNA. A 10-mL syringe, loaded to 5ml negative pressure, was attached in a locked position to the needle. Suction was applied after the lesion was punctured. The needle is moved back and forth 20-30 times by applying negative pressure suction within the lesion. Afterwards, the needle is withdrawn from the lesion."
15877772|NCT03821961|Procedure|Metabolic Surgery|Roux-en-Y gastric bypass, Sleeve gastrectomy
15877773|NCT03821935|Drug|ABBV-151|Liquid for intravenous infusion.
15877774|NCT03821935|Drug|Budigalimab|Lyophilized powder for solution for intravenous infusion.
15877775|NCT03821909|Procedure|Endoscopic ultrasound-guided protal venous blood sampling|We wil obtain portal venous blood samples via endoscopic ultrasound(EUS) in patients with suspected pancreatic masses.
15877776|NCT03821896|Behavioral|Conversation Cards for Adolescents and Goal-Setting|The intervention includes using an adolescent-tailored tool (a deck of cards) created by researchers at the University of Alberta and adolescents with obesity seeking weight management care. It contains a list of factors that make it easy or hard for teens to make and maintain healthy lifestyle changes. Its use will be paired with a S.M.A.R.T. goal-setting activity using principles of shared decision-making.
15877777|NCT03821896|Behavioral|Goal-Setting|Collaborative setting of S.M.A.R.T. goals using principles of shared decision-making.
15877778|NCT03821883|Drug|Aspirin Tablet|Aspirin 100mg qd
15877779|NCT03821883|Drug|Placebo|Placebo qd
15877780|NCT03821870|Diagnostic Test|Inditreat|Tumoroid formation and drug sensitivity analysis
15877781|NCT03821870|Drug|Experimental drug|Second line treatment based on drug sensitivity analysis
15877783|NCT03821844|Behavioral|Music and Memory|Music and Memory is a personalized music program in which caregivers (nursing home staff, family, or others) provide people with dementia with music playlists tailored to their personal history of music preferences.
15877784|NCT03821831|Device|Continuous Positive Airway Pressure|CPAP machine
15877785|NCT03821831|Device|Orthodontic intervention|Mandibular advancement or Rapid maxillary expansion devices
15877786|NCT03821818|Behavioral|Food Allergy Elimination + Willis Exercise|Food Allergy Elimination + Willis Exercise (performing a 2-minute Aerobic-surge exercise > 75% max heart rate, 5/day)
15877787|NCT03821805|Other|Foot reflexology massage|Foot reflexology technique of Father Josef was used as massage intervention
15877788|NCT03821792|Drug|Abiraterone Acetate|Given PO
15877789|NCT03821792|Drug|Apalutamide|Given PO
15877790|NCT03821792|Drug|Prednisone|Given PO
15877791|NCT03821779|Behavioral|In vivo social exposure|Subjects will be invited to give a 5 minutes oral presentation on the topic of their choice to five examiners displaying no facial emotional reaction, after a 5 minutes period of silent waiting in front of the examiners. This waiting period is prompt to elicit anticipation-type of social anxiety.
15877792|NCT03821779|Behavioral|Social exposure in a virtual reality setting|Subjects will give a 5 minutes oral presentation on the subject of their choice to a virtual reality panel composed of 5 examiners displaying no facial emotional reaction, after a 5 minutes period of silent waiting in front of the examiners. This waiting period is expected to elicit anticipation-type of social anxiety.
15877924|NCT03820804|Drug|Sapropterin|A pharmacological treatment for patients with Phenylketonuria, used alone or in combination with dietary treatment.
15877793|NCT03821779|Other|EEG recording|EEG will be recorded with a standard 16-electrodes cap. Recordings will start before the 5 minutes waiting period and continue throughout oral presentation and recovery. The recovery period will be used as a baseline control
15877794|NCT03821779|Diagnostic Test|Psychometric evaluation|"Subjects will be evaluated prior to inclusion using the following assessment tools
~Anamnestic Association for Methodology and Documentation in Psychiatry (AMDP) questionnaire
~Mini International Neuropsychiatric Interview (MINI 6.0, for psychiatric diagnoses)
~Liebowitz Social Anxiety Scale (LSAS)
~Montgomery Asberg Depression Rating Scale (MADRS)
~Brief Anxiety Scale of Tyrer (BAS)
~State-Trait Anxiety Inventory (STAI A-B)
~Global Assessment of Functioning (GAF)"
15877795|NCT03821779|Diagnostic Test|Visual Analogue Scale of anxiety|"Subjects will be asked to rate their anxiety levels
~immediately before (5 minutes of silent waiting),
~during
~and after the 5-minute oral presentation (recovery)"
15877796|NCT03821766|Device|Ballistocardiography and seismocardiography|SCG and BCG signals will be recorded by the mean of an unobtrusive and friendly device consisting of two houses, the first one placed on the sternum and the second one place on the lumbar region near the subject's center of mass. The signal will be transferred to a tablet by Bluetooth and tracings will be analysed automatically with Matlab. The SCG+BCG signals are synchronized to the intracardiac pressure tracings in order to allow a comparative interpretation between the two tracings.
15877797|NCT03821753|Other|Case|"OCT
~OCT-Angiography,
~Retinophotography
~Neuropsychological tests"
15877798|NCT03821753|Other|Control|"OCT
~OCT-Angiography,
~Retinophotography
~Neuropsychological tests"
15877799|NCT03821740|Other|Kinesiotaping|Mc Connel taping and another kinesiotaping technique
15877800|NCT03821727|Procedure|Hematopoietic Stem Cell Transplantation|Hematopoietic Stem Cell Transplantation in Acute Leukemia Ph positive
15877801|NCT03821714|Drug|Glucocorticoid combination therapy|Glucocorticoid combination therapy is defined as the combination of hydrocortisone, vitamin C, and vitamin B1.
15877802|NCT03821714|Drug|Glucocorticoid|The glucocorticoid group was defined as the use of hydrocortisone alone.
15877803|NCT03821701|Drug|Entresto|Sacubitril Valsartan Sodium Tablets, 100mg bid, among whole study
15877804|NCT03821701|Drug|ACEI/ARB|Choose one of ACEI/ARB according to the clinical condition among the whole study.
15877805|NCT03821688|Procedure|SAS-JB|
15877806|NCT03821688|Procedure|MBG|
15877807|NCT03821688|Procedure|LSG|
15877808|NCT03821675|Device|Electrical Stimulation|Subjects will receive an active electrical stimulation device to wear for 1 hour daily for 4 weeks.
15877809|NCT03821675|Device|Electrical Stimulation - Sham|Subjects will receive a sham electrical stimulation device to wear for 1 hour daily for 4 weeks.
15877810|NCT03821662|Behavioral|OT Diabetes Self-Management Intervention|Occupational therapy chronic disease self-management intervention.
15877811|NCT03821649|Behavioral|SOONER Training and Naloxone Kit Kit|Participants are shown our unique overdose response education video and given the associated kit to take home.
15877812|NCT03821649|Behavioral|Community or Hospital-Based Training|Referral to standard of care for Naloxone training
15877813|NCT03821636|Procedure|Standard Roux-en-Y gastric bypass|Standard Roux-en-Y gastric bypass is performed with a 30 ml gastric pouch, a stapled gastrojejunal anastomosis with an alimentary limb of 25 % of total length of the intestine (150 cm), connected to the biliary limb of 10 % of total length of the intestine (60 cm) below the duodeno-jejunal junction with a side-to-side jejuno-jejunal anastomosis and a common limb of 65 % of total length of the intestine (400 cm).
15877814|NCT03821636|Procedure|Long alimentary limb Roux-en-Y gastric bypass|Long alimentary limb Roux-en-Y gastric bypass is performed with a 30 ml gastric pouch, a stapled gastrojejunal anastomosis with an alimentary limb of 45 % of total length of the intestine (280 cm), connected to the biliary limb of 10 % of total length of the intestine (60 cm) below the duodeno-jejunal junction with a side-to-side jejuno-jejunal anastomosis and a common limb of 45 % of total length of the intestine (280 cm
15877815|NCT03821623|Drug|Nicotinamide riboside|Nicotinamide riboside, a dietary supplement available over the counter under the name NIAGEN®, (ChromaDex Inc) is an exogenous NAD+ precursor that reverses age-related arterial dysfunction in aged mice, suggesting that declining NAD+ may play a key role in cardiovascular aging.
15877816|NCT03821623|Other|Placebo|Subjects will take placebo pills twice a day for 3 months
15877817|NCT03821610|Drug|Fludarabine|IV
15877818|NCT03821610|Drug|Melphalan|IV
15877819|NCT03821610|Drug|Alemtuzumab|IV
15877820|NCT03821610|Drug|Cyclophosphamide|IV
15877821|NCT03821610|Drug|Mesna|IV
15877822|NCT03821610|Radiation|Total Body Irradiation (8Gy)|TBI (8Gy)
15877823|NCT03821597|Procedure|Sequential compression devices (SCDs)|Application of sequential compression devices in surgery.
15877824|NCT03821597|Procedure|No sequential compression.|No sequential compression devices are applied.
15877825|NCT03821584|Other|the difference of care management and prognosis, an early distinction of migraine aura based on imaging techniques will have a particular interest|the difference of care management and prognosis, an early distinction of migraine aura based on imaging techniques will have a particular interest
15877826|NCT03821571|Diagnostic Test|Brain MRI|Brain MRI with blood sensitive sequence (SWI) will be performed to all enrolled patients.
15877827|NCT03821558|Other|Exercise training|Patients to be randomized to the 'interval training group' or 'continuous training group' will undergo exercise training sessions with different intensity levels.
15877828|NCT03821545|Other|Lidocaine|Lidocaine will be administered at a dose of 1.5 mg/kg prior to surgical incision followed by an infusion at a rate of 1.5-2 mg/kg/hr until the end of surgery.
15877829|NCT03821545|Other|Ketamine|Ketamine will be administered at a dose of 0.5 mg/kg in a bolus prior to surgical incision followed by an infusion at a rate of 0.1-0.2 mg/kg/hr until the end of surgery.
15877830|NCT03821545|Other|Lidocaine and Ketamine|Lidocaine will be administered at a dose of 1.5 mg/kg prior to surgical incision followed by an infusion at a rate of 1.5-2 mg/kg/hr until the end of surgery. Ketamine will be administered at a dose of 0.5 mg/kg in a bolus prior to surgical incision followed by an infusion at a rate of 0.1-0.2 mg/kg/hr until the end of surgery.
15877831|NCT03821545|Other|Placebo (0.9% NaCl)|Bolus and continuous placebo infusion (0.9% NaCl) will be equally administered at the same dose as the aforementioned anesthetics until the end of the surgery.
15878153|NCT03819049|Biological|ExPEC4V|Participants will receive a single IM injection of ExPEC4V on Day 1.
15877832|NCT03821532|Other|Constipation Action Plan|Action plan, adapted from Autism Speaks Network, demonstrating Red, Yellow, and Green levels of symptoms with corresponding steps for treatment or action by parent/guardian, tailored by care provider to the child's condition.
15877833|NCT03821519|Biological|donor-derived CIK cells|Treatment plan will be based on three infusions of donor derived CIK cells given by 3 weeks intervals at increasing dose levels. No dose changes are allowed and the following planned dose levels will be administered to each patient enrolled: 5x106, 5x106 and 10x106 cells/Kg according to the dose escalating program
15877834|NCT03821506|Device|Dynamic Light|Dynamic Lighting system
15877835|NCT03821506|Device|Usual care|Standard lighting system
15877836|NCT03821493|Drug|PF-06651600 10 mg tablets|"On Day 1 in Period 1, a single oral dose of 30 mg (3 x 10 mg tablets) will be administered.
~On Day 4 of Period 2, a single oral dose of 30 mg (3 x 10 mg tablets) will be administered after itraconazole."
15877837|NCT03821493|Drug|Itraconazole Solution 200 mg|"Itraconazole 200 mg will be administered as 20 mL (10 mg/mL) oral solution once daily on Days 1-5 in Period 2.
~On Day 4 of Period 2, co-administration of itraconazole 200 mg and PF-06651600 30 mg will occur. Itraconazole will be administered first followed by PF-06651600 tablets."
15877838|NCT03821480|Drug|Test drug|Fluconazole capsule 50 mg Manufacturer: West Ryde
15877839|NCT03821480|Drug|Reference drug|Fluconazole capsule 50 mg Manufacturer: Amboise
15877840|NCT03821467|Device|Dual beam Doppler Fourier-domain OCT (DOCT)|Retinal blood flow will be assessed using DOCT.
15877841|NCT03821467|Device|Dynamic Vessel Analyzer (DVA)|Retinal vessel diameters and oxygen saturation will be measured with the DVA device.
15877842|NCT03821467|Device|Optical coherence tomography (OCT)|Retinal morphology will be imaged using OCT.
15877843|NCT03821454|Drug|Capecitabine|Oral capecitabine (at a dose of 1250 mg per square meter of body-surface area, twice per day, on days 1 to 14) every 3 weeks for eight cycles.
15877844|NCT03821454|Drug|Placebos|Oral Placebos (twice per day, on days 1 to 14) every 3 weeks for eight cycles.
15877845|NCT03821441|Biological|bOPV(Candy)|"A single dose of 1 pill orally of bOPV to subjects aged 48 months who recieved bOPV (candy) produced by institute of Medical Biology, Chinese Academy of Medical Sciences in primary immunization.
~If bOPV(candy/liquid) is not available ,in order to protect the rights and interests of subjects ,the investigator can adjust other poliovirus vaccine such as IPV replace bOPV."
15877846|NCT03821441|Biological|bOPV(Liquid)|"A single dose of 2 drops (0.1 ml) orally of bOPV to subjects aged 48 months who recieved bOPV (liquid) produced by institute of Medical Biology, Chinese Academy of Medical Sciences in primary immunization.
~If bOPV(candy/liquid) is not available,in order to protect the rights and interests of subjects ,the investigator can adjust other poliovirus vaccine such as IPV replace bOPV."
15877847|NCT03821441|Biological|bOPV(Liquid)|"A single dose of 2 drops (0.1 ml) orally of bOPV to subjects aged 48 months who received tOPV (liquid) produced by Beijing Tiantan Biological Products Co., Ltd. in primary immunization.
~If bOPV(candy/liquid) is not available,in order to protect the rights and interests of subjects ,the investigator can adjust other poliovirus vaccine such as IPV replace bOPV."
15877848|NCT03821428|Procedure|Acupuncture|Needling of P6 and CV24 points
15877849|NCT03821428|Procedure|Placebo|Application of placebo acupuncture needles to the areas, where the acupoints are situated
15877850|NCT03821415|Drug|RP101|17β-oestradiol-3-phosphate ophthalmic sterile solution
15877851|NCT03821402|Biological|DAXI for injection dose LOW DOSE|DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline
15877852|NCT03821402|Biological|DAXI for injection dose MEDIUM DOSE|DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline.
15877853|NCT03821402|Biological|DAXI for injection Dose HIGH DOSE|DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline
15877854|NCT03821402|Other|Placebo|Placebo is a sterile lyophilized product consisting of inactive ingredients without the neurotoxin to be reconstituted with sterile, non-preserved 0.9% sodium chloride solution.
15877855|NCT03821389|Device|NIOD Frequencer|NIOD will be implemented on four different parts of the chest walls, 3 minutes for each part and 12 minutes in total per each session. Left and right front and posterior chest walls will be stimulated (Figure1), particularly, on the anterior chest, intercostal spaces 1-2 above nipple line and lateral side of the midclavicular line 1-2 below intercostal spaces. The intensity of the NIOD can be selected between 80-100%, which is prespecified on the machine.
15877856|NCT03821376|Drug|Contrast enhanced ultrasound with Lumason|Following consent, they will undergo contrast enhanced ultrasound of their known renal mass(es). This will be performed at University hospital following intravenous administration of Lumason (2.5 mL per injection, maximum of 2 injections per mass).
15877857|NCT03821363|Biological|SCT-I10A|Experimental: Anti- PD-1 monoclonal antibody（SCT-I10A）
15877858|NCT03821350|Other|Information leaflet|The written and visual information form prepared specifically for the patients was aimed to provide detailed information by clearly expressing the procedure, the suggestions that will be needed before and after injection (what to bring next, what circumstances may not be done, the control visit day after the procedure etc.) to be applied on before the injection day.
15877859|NCT03821337|Device|repetitive Trans Magnetic Stimulation|Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique that is able to alter cortical excitability and is FDA-approved to treat Major Depressive Disorder. Magnetic fields pass unimpeded through the scalp, skull and meninges, and can directly excite cortical areas.
15877918|NCT03820856|Procedure|acupuncture|We selected acupoints that have often been recommended for the treatment of lateral epicondylitis. Triple needling was performed at the Ah shi point, i.e., the 1-2-cm area encompassing the most painful spot on the humeral epicondyle. We also manipulated acupuncture needles in the following areas: LI10 (Shousanli), LI11 (Quchi), LI12 (Zhouliao) and LU5 (Chize). The treatments were administered twice weekly for 6 weeks.
15877919|NCT03820843|Other|Art therapy and standard orthophonic rehabilitation|In addition to standard orthophonic rehabilitation, the patient will receive 12 sessions of art therapy
15877860|NCT03821337|Device|Sham TMS|Sham sessions will be delivered using an electronic sham system consisting of a coil that mimics the appearance and sound of TMS, combined with a TENS device which produces a small electric shock mimicking the feeling of real rTMS. This type of sham has been demonstrated to be indistinguishable from real rTMS, has been well tolerated (George et al., 2010; George et al., 2014) and successfully used in other clinical trials (Borckardt et al., 2008; Arana et al., 2008). During each session of rTMS the investigators will present a series of opioid related images, including those utilized in previous studies (Garland et al., 2015; Garland & Howard, 2014).
15877861|NCT03821324|Device|Venus Viva|The Venus Viva™ fractional RF device has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars. Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits.
15877862|NCT03821311|Radiation|Computed tomography|End-inspiratory/end-expiratory CT is repeated 3 times corresponding to the 3 studied conditions: At baseline, through expiratory resistive loading using an adjustable PEP mask, and after 5 min of nasal high flow therapy at 25 L/min.
15877863|NCT03821298|Other|Standard of Care Hand Therapy|8 sessions 2 times a week for 4 weeks
15877864|NCT03821285|Procedure|Pulmonary Rehabilitation|Pulmonary rehabilitation programme:15 aerobic-training sessions, 15 strength-training sessions for peripheral muscles, 3 face to face and/or Group educational sessions, if needed airways clearance techniques and/or inspiratory muscles training
15877867|NCT03821259|Other|Psychological measures|Participants will be asked to provide basic demographic information and to complete five measures, screening for cognitive impermanent and measuring PTSD symptoms, lifetime trauma exposure, emotion regulation and group identification.
15877868|NCT03821246|Drug|Atezolizumab|Given IV
15877869|NCT03821246|Drug|Tocilizumab|Given IV
15877870|NCT03821246|Drug|Etrumadenant|Given Orally
15877871|NCT03821233|Drug|ZW49|"Dose Escalation: ZW49 administered intravenously at dose levels determined by the SMC
~Expansion: MTD or RD identified in the dose-escalation part of the study"
15877872|NCT03821220|Behavioral|Motivational Interview support and Dietitian support|Three sessions of a structured motivational support intervention. Each patient will be required to set a SMART physical activity personal objective. The sessions will cover possible barriers and facilitators, enhancing self-efficacy, and feedback. In addition two sessions with a dietitian to discuss ways to improve current health habits.
15877873|NCT03821220|Behavioral|Activity tracker plus usual care|Each patient will receive their own activity tracker (vivofit 3) with instructions on use, in addition to usual care, and written handouts for pre-diabetic patients.
15877874|NCT03821220|Behavioral|Personalized physical activity prescription|Each patient will receive a personalized prescription of recommended physical activity including type of activity, duration and frequency.
15877875|NCT03821207|Behavioral|The exercise group|The students will make exercise during the first three days of the menstrual period
15877876|NCT03821207|Behavioral|The abdominal massage group|The students will make abdominal massage during the first three days of the menstrual period
15877877|NCT03821207|Behavioral|Control Group|The students will nor massage or exercise
15877878|NCT03821194|Other|Gua sha|Scrape the skin around the knee joint
15877879|NCT03821194|Other|hot pack|hot pack
15877880|NCT03821181|Device|RIC group|Patients allocated to the RIC group will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 50 mmHg over systolic blood pressure for five cycles of 5 min followed by 5 min of relaxation of the cuffs.
15877881|NCT03821181|Device|Sham group|patients allocated to the sham group will undergo a sham RIC procedure during which bilateral arm cuffs are inflated to a pressure of 30 mmHg for five cycles of 5 min, followed by 5 min of relaxation of the cuffs.
15877882|NCT03821168|Drug|injection of bevacizumab and erythropoietin|injection of bevacizumab and erythropoietin
15877883|NCT03821168|Drug|injection of bevacizumab|under gone 3 intravitreal injection of bevacizumab monthly and examine monthly for Visual acuity and central macular thickness
15877884|NCT03821155|Other|Vestibular rehabilitation|Specialized physical therapy aimed at restoring balance
15877885|NCT03821155|Drug|Corticosteroid|Prednisolone
15877886|NCT03821142|Device|Transvaginal mesh for anterior pelvic organ prolapse repair|synthetic mesh for anterior pelvic organ prolapse with or without apical vaginal wall involvement via the vaginal route in a highly selected patient population
15877887|NCT03821129|Device|PFO closure with GORE® CARDIOFORM Septal Occluder|PFO closure with GORE® CARDIOFORM Septal Occluder in patients with ischemic stroke
15877888|NCT03821116|Other|Milk|Swedish milk from cow.
15877889|NCT03821116|Other|Soured milk (filmjölk)|Swedish soured milk (from cow milk).
15877890|NCT03821103|Behavioral|Training|The training includes of (1) in-person training with pre- and post-session knowledge and attitude assessment, (2) three month post-session knowledge and attitude assessment and (3) self-report of first-time buprenorphine-naloxone Emergency Department (ED) administration within 3 month study period
15877891|NCT03821103|Behavioral|Behavioral economic enhanced arm|Behavioral economic enhancement includes an opt-out invitation, loss-framed incentivization, weekly tailored text based reminders
15877920|NCT03820830|Drug|Palbociclib 125mg|Palbociclib 125 mg oral tablet taken daily for 3 years from randomization
15877921|NCT03820830|Drug|Standard endocrine therapy|Aromatase inhibitor (anastrozole or exemestane or letrozole) oral daily tablet, or Selective Estrogen Receptor Modulator (SERM) such as tamoxifen oral daily tablet or fulvestrant (Faslodex) injection once every 2 weeks for 3 doses then every month. Premenopausal women and men may also receive an LHRH (luteinizing hormone-releasing hormone) agonist by injection. Standard endocrine therapy will be given for at least 3 years from randomization.
15877893|NCT03821064|Other|Patient Navigation|NDURE is a theory-based, multi-level patient navigation (PN) intervention consisting of clinic-based sessions of manualized PN to reduce barriers to care, increase HNC care delivery, and improve clinical outcomes (timely, equitable PORT). NDURE will be delivered from surgical consultation to PORT initiation (~3 months). The three in-person NDURE sessions, which are expected to take 30-60 minutes each, will coincide with the presurgical consult, hospital discharge, and 1st postoperative clinic visit. During the first session, the navigator will 1) elicit barriers and facilitators to timely PORT, 2) develop the personalized barrier reduction plan (BRP), review the BRP with the patient, caregiver, and provider, and 3) implement the BRP. At the two subsequent sessions, the navigator will review and update the BRP in an iterative, dynamic fashion, identifying new barriers and systematically tracking resolution of prior barriers until the start of PORT.
15877896|NCT03821025|Device|Biliary stent|Palliation of malignant biliary obstruction
15877897|NCT03821012|Other|in-hospital process optimization|
15877898|NCT03821012|Other|PPCI hospital-based regional STEMI transfer network construction|
15877899|NCT03821012|Other|the whole-city STEMI care network construction|
15877900|NCT03820999|Other|Oral and written information on tick-bites and Lyme disease|See under study arm descriptions
15877901|NCT03820986|Biological|Pembrolizumab|IV infusion
15877902|NCT03820986|Drug|Lenvatinib|Oral capsule
15877903|NCT03820986|Drug|Placebo for lenvatinib|Oral capsule
15877904|NCT03820973|Behavioral|Brief CBT for Anxiety|All participants will receive psychoeducation on anxiety and bCBT treatment approach, work on setting goals, begin self-monitoring, and select skill sessions that fit his/her most pressing needs. Available skills: Relaxation-Diaphragmatic breathing is a simple relaxation technique that increases oxygen flow and reduces the unpleasant physiological sensations associated with anxiety; Exposure - designed to educate Veterans about the role of avoidance in maintaining anxiety problems, as well as information about how to reduce avoidance through exposure exercises; Cognitive - Veterans may opt to address anxiety and worry through modifying negative thinking patterns. Two available options - Increasing Helpful Thoughts and Managing Unhelpful Thoughts.
15877905|NCT03820947|Device|VenaSeal™ Closure System|The VenaSeal™ closure system is the non-tumescent, non-thermal, non-sclerosant device that uses a proprietary medical adhesive delivered endovenously to close the vein.
15877906|NCT03820947|Device|Endothermal Ablation (ETA)|"ETA includes EVLA that uses laser or RFA that uses radiofrequency heating to close the vein. Heat is applied in both EVLA and RFA therapies to close the vein.
~Subject can be treated with either EVLA or RFA if randomized to ETA arm per site's standard practice."
15877907|NCT03820947|Procedure|Surgical Stripping|Surgical stripping involves stripping (removal) of the diseased vein via surgical procedures.
15877908|NCT03820934|Diagnostic Test|Fibroscan and Fibrosure|Patient's will undergo fibroscan and fibrosure to test their liver for the level of liver fibrosis as measured by these tests. Fibroscan uses vibrations sent through the liver to measure its stiffness and the fibrosure uses laboratory and demographic parameters to create a score associated with a certain level of fibrosis. The scores from these tests will then be compared to the amount of fibrosis noted on a standard of care liver biopsy.
15877909|NCT03820921|Diagnostic Test|EUS-FNB|"EUS WITH EUS-FNB will be performed for confirmation of diagnosis and analysis of MMR status and PD-L1 expression
~Protocol of EUS with EUS-FNB should include linear EUS instruments with complete examinations of the pancreas. Tumor characteristics (echogenicity, echostructure, size) will be described as well as presence/absence of power Doppler signals.
~EUS-FNB will be performed in all pancreatic masses with at least three passes in the absence of an onsite cytopathologist using a fanning technique with a 22-gauge needle (SharkCore FNB needle Medtronic Corp. or Acquire FNB needle Boston, MA)."
15877910|NCT03820921|Other|Immunohistochemistry|IHC will be performed on treatment-naïve formalin-fixed paraffin-embedded EUS-FNB pancreatic specimens. Briefly, 4-μm-thick tissue sections will be stained using the Ventana BenchMark XT automated slide-staining system using the following antibodies: Anti-PD-L1 (clone SP263, VENTANA, Tucson, AZ), MLH1 (clone G168-728, Cell Marque, Rocklin, California, United States), MSH2 (clone FE11, Biocare Medical, Concord, Massachusetts, United States), MSH6 (clone BC/44, Biocare Medical, Concord, Massachusetts, United States), and PMS2 (clone A16-4, Biocare Medical, Concord, M Massachusetts, United States). Antigen-antibody reactions will be visualized using UltraView detection with diaminobenzidine as the chromogen. The specimen will be considered to have PD-L1 expression if PD-L1 is expressed in ≥ 1 % of tumor cells and a high level of expression if ≥ 50 %. Tumors will be classified as dMMR if they exhibit absent nuclear staining of DNA mismatch repair proteins (MLH1, MSH2, MSH6, or PMS2).
15877911|NCT03820908|Drug|Bisantrene|The patients will receive bisantrene 250mg/m2/d for 7 days in conjunction with the conventional supportive care.
15877912|NCT03820895|Diagnostic Test|Blood test|Serum 25-hydroxyvitamin D 25(OH) D levels were measured for Vitamin D status, by electrochemiluminescence immunoassay (Roche, USA). Cobb's angle measurement was done by measuring the major spinal curve and was taken from the upper end vertebra to the lower end vertebra through an x-ray for all the patients included in the study.
15877913|NCT03820882|Device|Catfish|Patients will be treated for mechanical recanalization with Catfish within 8 hours after stroke onset plus standard medical management.
15877914|NCT03820882|Device|Solitaire FR|Patients will be treated for mechanical recanalization with Solitaire FR within 8 hours after stroke onset plus standard medical management.
15877915|NCT03820869|Other|Family Training|Family Training
15877916|NCT03820869|Other|Occupational Therapy|Occupational Therapy
15877917|NCT03820856|Procedure|acupuncture plus fire needle therapy|The protocol used in this group was the same as that used in the acupuncture alone group except that fire needle therapy was added. The treatments were administered twice weekly for 6 weeks. Fire needle therapy was performed as follows: an acupuncture needle made of tungsten was heated until red-hot over a lighter and then inserted into the two Ah shi points (the tender points on the common extensor tendon, specifically extensor carpi radialis). The red-hot needle was inserted rapidly into the Ah shi point (approximately 5-8 fen deep, 1 cun = 10 fen) for approximately half a second and then removed. Pressure was then applied to the needle hole using a sterilized dry cotton ball.
15877923|NCT03820804|Other|Diet|A specific dietary treatment for patients with Phenylketonuria.
15877925|NCT03820791|Device|Placement of a poster in patients' rooms|Patients and their caregivers will be exposed to the poster for one month
15877926|NCT03820778|Diagnostic Test|Whole Body MRI|WBMRI with axial and coronal STIR (short inversion time inversion recovery) images + DWI (diffuse weighted imaging) will be performed and compared to regional MRI to assess value of this diagnostic test for the identification of suspicious looking lesions (i.e. diffuse nodular lesions or atypical plexiform neurofibroma)
15877927|NCT03820739|Other|Follow-up|No investigational vaccine will be administered during this study
15877928|NCT03820739|Other|Blood sample collection|Blood sampling to assess vaccine-induced immune responses will be conducted only in cohort 1 in a subsample consisting of approximately 102 adults and 165 children (55 from each of the three paediatric age groups that were enrolled in EBOVAC-Salone: 12-17 year olds, 4-11 year olds, and 1-3 year olds).
15877930|NCT03820713|Procedure|Concentrate of plasma coagulation factors|The plasma concentrate of coagulation factors is applied to the surgical site.
15877931|NCT03820713|Procedure|0.9% saline|Control group receives an identical syringe and applicator generated by processing normal saline 0.9% instead of plasma.
15877932|NCT03820700|Behavioral|Hypnosis (Hypn)|The hypnosis session will consist of a 20-minute hypnosis recording created by Marie-Elisabeth Faymonville and recorded by Anne-Sophie Nyssen, both professionals in hypnosis from University of Liège. The recording includes suggestions about relaxation, corporal sensations, respiratory techniques and visual imaginative stimuli about a beautiful landscape. With this tool, the hypnosis session is standardized for all patients and there is no need of a psychotherapist to deliver hypnosis.
15877933|NCT03820700|Behavioral|Virtual reality (VR)|VR sessions. This session will consist in using a head-mounted 3D graphical display with goggles. With this tool, participants will be able to visualize a 3D immersive landscape for 20 minutes consisting of a shed near a lake at sunrise followed by a relaxing moment in the clouds. The session ends on the lake's edge.
15877934|NCT03820700|Behavioral|Virtual reality hypnosis (VRH)|The combined tool sessions. Participants will be simultaneously subjected to the same hypnosis recording and 3D visual stimuli used in the Hypn and VR conditions.
15877935|NCT03820687|Other|Clinical Trial Educational Video|Culturally tailored educational video, brochure, and support from a patient navigator to empower new cancer patients to make informed decisions about cancer clinical trials.
15877936|NCT03820687|Other|Clinical Trial Fact Sheet|General Clinical Trial fact sheet with usual care information regarding Clinical Trials.
15877937|NCT03820687|Other|Brochure|A brochure with educational material about clinical trials and services offered by Mays Cancer Center.
15877938|NCT03820687|Other|Navigator|Support that will be provided by a patient navigator to empower new cancer patients to make an informed decision about cancer clinical trials by increasing awareness of clinical trials and MCC services, positive attitudes and intentions to consider clinical trials as an appropriate treatment option.
15877939|NCT03820674|Other|Energy Conservation plus Problem Solving Therapy|EC-PST is a client-centered intervention aiming to guide people with chronic fatigue to create their own solutions so that they can generalize those learned solutions and strategies to other fatigue-related problems even after completing the study participation. Some of the topics covered during the first two introductory sessions are facts regarding fatigue, budgeting and banking energy, and the introduction of EC+PST Intervention.
15877940|NCT03820674|Other|Health Education Intervention|The interventionist will be the PI, an occupational therapist (co-I), or OT graduate student who will be trained in the health education topics. During the Health Education sessions, participants will be educated on health-related topics relevant to CHF and EC strategies, although they will not learn how to apply the information to their daily life. Health Education Workbook containing information on the topics taught during the sessions will be provided during the Pretest visit and used throughout the Health Education sessions.
15877941|NCT03820661|Device|Ultrasound|High resolution ultrasound pre-operatively and intra-operatively
15877942|NCT03820648|Device|Alexis|The Alexis® (Applied Medical) is a surgical device indicated for use in retracting and protecting an incision during laparoscopic or open surgery. It is intended to allow the surgeon to access through an atraumatic circumferentially 360 degrees retracted wound that provides maximum exposure with minimum incision size. Further, once positioned, the Alexis Wound Retractor is intended to protect against wound contamination.The device will be manufactured in five sizes, extra-small, small, medium, medium-large and large. The Alexis Wound Retractor has been found non-toxic and non-irritant when tested in accordance with ISO 10993, Part 1: Biological Evaluation of Medical Devices. The materials used in the manufacturing of the Alexis Wound Retractor have been tested in accordance with applicable standards and was determined to pass tensile strength, elongation, (ASTM D 412) and Tear Strength (ASTM D 624). Functional performance testing has been completed and has passed the required testing.
15877943|NCT03820648|Device|Standard 3M™ Steri-Drape 2|Standard 3M™ Steri-Drape 2 is a standard drape applicated on the skin of the patient before the surgical incision.
15877944|NCT03820635|Diagnostic Test|Osteopontin (OPN)|the serum level of Osteopontin (OPN) will be measured in the subject's blood sample
15877945|NCT03820622|Device|Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR)|patients in the study group will be treated by the Paclitaxel-Eluting Coronary Balloon Dilation Catheter (DIOR)
15877946|NCT03820622|Device|Paclitaxel-Eluting Balloon (Bingo)|patients in the study group will be treated by the Paclitaxel-Eluting Balloon (Bingo)
15877947|NCT03820609|Behavioral|Digital Intervention|This digital application for sexual assault prevention can be completed on a tablet computer.
15877948|NCT03820596|Drug|Sintilimab|"To evaluate the short-term objective efficacy of sintilimab combined with chidamide in the treatment of refractory and relapsed ENKTCL patients, and to determine the MTD, DLT/RP2D of chidamide.
~To evaluate the long-term efficacy and safety of sintilimab combined with chidmide in the treatment of refractory and relapsed ENKTCL patients. Exploring biomarkers that may have predictive effects."
15877949|NCT03820596|Drug|Chidamide|"To evaluate the short-term objective efficacy of sintilimab combined with chidamide in the treatment of refractory and relapsed ENKTCL patients, and to determine the MTD, DLT/RP2D of chidamide.
~To evaluate the long-term efficacy and safety of sintilimab combined with chidmide in the treatment of refractory and relapsed ENKTCL patients. Exploring biomarkers that may have predictive effects."
15878154|NCT03819049|Biological|Prevnar 13|Participants will receive a single IM injection of Prevnar 13 on Day 1.
15877950|NCT03820583|Procedure|Whipple Procedure|Patients underwent Whipple procedure for pancreatic tumors. The procedure commenced with rooftop incision. then layers of abdomen dissected to reach the peritoneum. Then Duodenum dissected out along with pancreas and common bile duct. After rescetion of these structures the anatomy of the tract restored with three anastomosis namely pancreaticojejunostomy, gastrojejunostomy and choledochojejunostomy/hepaticojejunostomy.
15877951|NCT03820570|Procedure|hernia repair|inguinal hernia repair
15877952|NCT03820557|Other|Educational Intervention|Undergo Decision Counseling Program
15877953|NCT03820544|Procedure|Endoscopic Retrograde Cholangiopancreatography|Undergo ERCP with SEMS placement
15877954|NCT03820544|Other|Standard of care|Undergo standard of care surgical resection
15877955|NCT03820531|Diagnostic Test|Next Generation Sequencing|DNA Mutational Analysis in pancreas cyst fluid concerning KRAS/GNAS-mutations and mutations in tumor supressor genes
15877956|NCT03820531|Diagnostic Test|CEA and lipase|"Measuring CEA and lipase level in pancreas cyst fluid:
~CEA > 192 ng/ml and lipase > 200 U/l = mucinous cyst"
15877957|NCT03820531|Diagnostic Test|Cytology|"Cytology in pancreas cyst fluid:
~mucinous versus non-mucinous cyst; LGD versus HGD/Carcinoma"
15877958|NCT03820531|Diagnostic Test|Histology of resected pancreas cyst|Histology of resected pancreas cyst concerning mucinous versus non-mucinous cyst, IPMN versus non-IPMN and LGD versus HGD/Carcinoma
15877959|NCT03820518|Drug|Calcitriol|
15877960|NCT03820492|Diagnostic Test|OCT, FFR, CTA and FFRCT|Multimodality assessment of intermediate left main stenosis: Comparison of optical coherence tomography-derived minimal lumen area, invasive fractional flow reserve and FFRCT
15877961|NCT03820479|Other|Protocol|Best practice of protocol
15877962|NCT03820466|Drug|Aspirin|Once daily application of platelet inhibiting medication
15877963|NCT03820466|Drug|Atorvastatin|Once daily application of lipid lowering medication
15877964|NCT03820466|Drug|Placebo Aspirin|Once daily application of placebo
15877965|NCT03820466|Drug|Placebo Atorvastatin|Once daily application of placebo
15877966|NCT03820453|Dietary Supplement|Tribulus Terrestris|The experimental arm will receive a dietary supplement to increase the libido and sexual function
15877967|NCT03820453|Other|Placebo treatment|The control arm will receive a placebo product with similar organoleptic qualities and the same posology characteristics
15877968|NCT03820440|Diagnostic Test|End-expiratory occlusion test (EEOT)|The EEOT is performed by interrupting the mechanical ventilation for 30 seconds, by using and end-expiratory hold on the ventilator.
15877969|NCT03820440|Diagnostic Test|Lung recruitment manovre (LRM)|The LRM is performed by using a single act of mechanical ventilation in pressure-controlled mode at 30 cmH20 for 30 seconds
15877970|NCT03820427|Diagnostic Test|impulse oscillometry|impulse oscillometry
15877971|NCT03820427|Diagnostic Test|multiple breath washout test|multiple breath washout test
15877972|NCT03820427|Diagnostic Test|body plethysmography|body plethysmography
15877973|NCT03820414|Biological|CRV 101|(Different formulations)
15877974|NCT03820414|Biological|Placebo|2 doses administered IM in deltoid region of non-dominant arm
15877975|NCT03820401|Device|choice of dialyzer|Fiber blocking is calculated in different commercially available dialyzers
15877976|NCT03820401|Other|choice of dialysis mode|Fiber blocking is calculated in different commercially available dialyzers used in different dialysis stategies
15877977|NCT03820401|Other|choice of anticoagulation strategy|Fiber blocking is calculated in different commercially available dialyzers using different anticoagulation strategies
15877978|NCT03820401|Other|preparation of dialyzer|Fiber blocking is calculated in different commercially available dialyzers either preprimed with Albumin or not
15877979|NCT03820388|Drug|Propofol 2mg/kg|2 mg/kg
15877980|NCT03820388|Drug|Etomidate 0.3 mg/kg|0.3 mg/kg
15877981|NCT03820388|Drug|Propofol 1 mg/kg|1 mg/kg Propofol
15877982|NCT03820388|Drug|Etomidate 0.15 mg/kg|0.15 mg/kg Etomidate
15877983|NCT03820336|Dietary Supplement|Extra Virgin Olive Oil|Subjects will consume 45 ml (40 g) of EVOO daily for 8 weeks.
15877984|NCT03820336|Dietary Supplement|Control Oil|Subjects will consume 45 ml (40 g) of a control sunflower seed oil daily for 8 weeks.
15877985|NCT03820323|Diagnostic Test|POC VL and targeted DRM testing.|Point-of-care Viral Load Testing will be done to ensure that providers and caregivers receive the results with in 24 hours study. Targeted DRM testing will be performed during the initiation of ART and when viremia (VL>1000 copies/mL) is detected.
15877986|NCT03820310|Biological|autologous Tcm cellular immunotherapy|autologous cellular immunotherapy plus traditional therapy. • cells will be infused in 3-5×109 cells/100 ml 1 month after radical resection, then cells will be infused as the same dose followed by a 1 month rest period, Each subject in experimental group will receive a total of 5 cell infusions.
15877987|NCT03820297|Behavioral|10 sessions of ASGI|10-session intervention will occur weekly for 45 minutes per session: psychoeducation about mood and anxiety disorders, focusing on identification of risk factors and biological theory to counter stigma; psychoeducation regarding 'therapeutic modules' (psychotropics and psychotherapy) to treat depression, with an emphasis on the importance of psychiatric treatment adherence, providing behavioral strategies for anticipated and experienced forms of mental illness related work, social, or family discrimination
15877988|NCT03820271|Other|SuperMELD|"The population of this arm will consist of patients newly enrolled in the National Liver Transplantation Waiting List for decompensated cirrhosis, whose liver function and MELD score are assessed at enrollment and then routinely reassessed at least quarterly during the waiting phase.
~Patients will be followed from their listing to transplantation or discharge or death."
15877989|NCT03820258|Drug|SOF/VEL/VOX|Administered once daily with food.
15877990|NCT03820245|Dietary Supplement|Bixin|Volunteers consumed bixin capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol)
15877991|NCT03820245|Dietary Supplement|Norbixin|Volunteers consumed norbixin capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol)
15877992|NCT03820245|Dietary Supplement|Lycopene|Volunteers consumed lycopene capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol)
15878155|NCT03819049|Biological|Placebo|Participants will receive single IM injection of matching placebo on Day 1.
15877993|NCT03820245|Dietary Supplement|Placebo|Volunteers consumed placebo capsules during 1 week , maintaining their usal lifestyle (avoiding excessive/unusual of fat and carotenoid-containing food, alcohol)
15877994|NCT03820232|Device|temperature monitoring|In every patient observed in this prospective observational study, body core temperature will be contemporaneously monitored through the oesophageal probe and the heated controlled servo sensor. Both are routinely used for this purpose in clinical practice
15877995|NCT03820219|Device|Prevena™ system|The Prevena™ System acts by removing exudate from a clean, closed incision. It helps hold the edges of the incision together, protecting the surgical site from external contamination in a clean, protected postoperative wound environment.
15877996|NCT03820219|Other|Standard sterile wound dressing|Standard wound care involves the application of an occlusive dressing in the operating room.
15877997|NCT03820206|Drug|Tranexamic Acid|1 g (10 mL) tranexamic acid stored in a dry container at 15 °C-30 °C) diluted in 20 mL of 5% glucose slowly administered intravenously 15 minutes before skin incision over a 5-minute period.
15877998|NCT03820206|Procedure|Cesarean section|Lower segement transverse cesarean section
15877999|NCT03820193|Drug|Celecoxib|Post-Operative Non Opioid Pain Protocol
15878000|NCT03820193|Drug|Hydrocodon/Acetaminophen|Traditionally used narcotic pain control
15878001|NCT03820193|Drug|Ketorolac|Post-Operative Non Opioid Pain Protocol
15878002|NCT03820193|Drug|Gabapentin|Post-Operative Non Opioid Pain Protocol
15878003|NCT03820193|Drug|Acetaminophen|Post-Operative Non Opioid Pain Protocol
15878004|NCT03820193|Drug|Diazepam|Post-Operative Non Opioid Pain Protocol
15878005|NCT03820180|Drug|Test Product|2 inhalations of Test and Reference product in each study period
15878006|NCT03820180|Drug|Reference Product|2 inhalations of Test and Reference product in each study period
15878007|NCT03820154|Diagnostic Test|Skin Prick Test|Skin Prick Testing with inhalant allergens
15878008|NCT03820154|Diagnostic Test|Skin Prick Test TAPE|Skin Prick Testing with a Tape, integrating the allergens and needles
15878009|NCT03820141|Drug|Durvalumab|programmed cell death-ligand 1 inhibitor
15878010|NCT03820141|Drug|Trastuzumab|anti-HER2 monoclonal antibody
15878011|NCT03820141|Drug|Pertuzumab|anti-HER2 monoclonal antibody
15878012|NCT03820128|Other|Early diet intervention|Participant's diet includes several low-fiber and low-fat commonly available meals and products. Patients will choose what they want to eat with no amount or calories restriction.
15878013|NCT03820115|Device|Elastic abdominal binder|Each woman in the intervention group is fitted with an elastic abdominal binder at the time of procedure completion just before leaving the operating room. The binder is placed snuggly tight (keeping in mind patient's comfort) on top of the hospital gown with the incision positioned at the middle part of the binder. The patients are encouraged to wear binders at all time. However, periods of break from wearing the binder are allowed at their convenience.
15878014|NCT03820089|Diagnostic Test|Ultrasonography TP|TP us will be made to the included women
15878015|NCT03820076|Other|AZT-04|Staphylococcus epidermidis
15878016|NCT03820063|Drug|PTC-Pz|"Paclitaxel 80mg/m2 administered intravenously on day 1 and day 8
~Herceptin® 6mg/kg administered intravenously on day 1 (loading dose 8mg/kg) or Herceptin® administered subcutaneously 600mg on day 1
~Carboplatin AUC 6mg•ml/min administered intravenously on day 1
~Pertuzumab 420mg administered intravenously on day 1 (loading dose 840mg)
~Treatment cycles are repeated on day 22
~In case of non pCR; Adjuvant T-DM1, 3.6mg/kg Q 22 days, for 14 cycles."
15878017|NCT03820050|Device|Freestyle LIbre Flash Glucose Monitoring System|System Performance will be characterized with respect to YSI reference venous plasma measurements
15878018|NCT03820037|Drug|Ongentys|single oral 50 mg (capsule containing 50 mg OPC) under fasting conditions
15878019|NCT03820037|Drug|BIA 9-1067 (test)|single oral 50 mg (capsule containing 50 mg OPC) under fasting conditions
15878020|NCT03820024|Behavioral|Tailored Feedback Messages|Participants randomized to the message arm will begin receiving encouragement and reminder UNC CHART messages to increase physical activity weekly. Participants on the feedback arm will receive 1 message per week during the 3-month study period.
15878021|NCT03820011|Other|PEM+|PEM+ is a five-step recursive process (i.e., the caregiver can repeat the five-step process to create as many intervention plans for their child as needed, relative to the number of activities in which change is desired based on the YC-PEM e-PRO, and it offers tiered support to the user during completion (tier 1: frequently asked questions available in the application, tier 2: support provided by email, tier 3: support provided by phone).
15878022|NCT03819998|Diagnostic Test|measurement of Fetuin-A level in serum|Fetuin A level will be measured in blood of the PCOS women
15878023|NCT03819985|Radiation|Hypofractionated Radiation Therapy|Undergo hypofractionated RT
15878024|NCT03819985|Other|Quality-of-Life Assessment|Ancillary studies
15878025|NCT03819985|Other|Questionnaire Administration|Ancillary studies
15878026|NCT03819972|Dietary Supplement|Dose response of Capolac®|Capolac® (milk minerals high in calcium) dose is manipulated
15878027|NCT03819946|Device|esophageal cooling device (Attune Medical, Chicago, IL)|The esophageal cooling device is a silicone soft tubing that is designed to be inserted into the esophagus. It is currently used clinically to provide whole body cooling or temperature control for intensive care patients (in medically induced coma or general anesthesia). The tubing is established but not been used in the clinical setting of catheter ablation for AF (which is performed under general anesthesia). During application of ablation energy to the posterior left atrial wall, the tubing is cooled to medium-low levels (25 degrees) and this is controlled by the operator.
15878028|NCT03819946|Other|Standard esophageal temperature probe|If the participant is randomized to the control group, then a standard esophageal protection method will be used during their catheter ablation procedure. This comprises of an esophageal temperature probe, inserted whilst the patient is under general anesthesia. If during application of ablation treatment to the posterior left atrial wall causes the esophageal temperature to rise above 38 degrees the ablation treatment is halted in this region. If ablation treatment is incomplete, re-application can be applied again cautiously if temperatures fall back to 37 degrees. Further temperature rise of over 38 degrees at the same region is a contra-indication to further ablation work here.
15878156|NCT03819036|Other|Questionnaires|Day 0 : Satisfaction questionnaire immediately after consultation Day 1, Day 3 and Day 7 : Telephone follow-up
15878029|NCT03819933|Behavioral|Educational intervention|Investigators will first determine preferred language and approaches by families, then redefine current training for prenatal counseling at extreme prematurity by developing and implementing two novel, interdisciplinary simulation-based educational programs for MFM and Neonatology (a workshop and an online module), focusing on eliciting values and building partnerships through advanced communication and relational skills, to improve counseling practices and outcomes
15878030|NCT03819920|Behavioral|Risk Assessment (CCRAT)|Patient receive personalized colorectal cancer risk assessment over the telephone by answering the questions as outlined in the National Cancer Institute Colorectal Cancer Risk Assessment Tool (https://ccrisktool.cancer.gov/calculator.html)
15878031|NCT03819920|Behavioral|Usual Care (UC)|Patients receive standardized general information about colorectal cancer screening over the telephone.
15878032|NCT03819907|Combination Product|Audiovisual Guided Relaxation|Five-minute guided relaxation delivered via a computer screen and speakers
15878033|NCT03819907|Combination Product|Virtual Reality Guided Relaxation|Five-minute guided relaxation delivered via a Samsung Galaxy 7s and the Samsung adaptable VR headset.
15878034|NCT03819894|Diagnostic Test|Introduction of a lower female hs-cTn threshold|The new female hs-cTn threshold will be baed on current recommendations for each of the assays used (hs-cTn T and I). The hospitals are the unit of randomization. At 5-month intervals, randomly selected hospitals will be advised that they are to transition to the intervention phase. For all men, the standard of care, overall population threshold will be used throughout the entire study.
15878035|NCT03819881|Biological|STMC-103H|Live bacterial product
15878036|NCT03819881|Biological|Placebo|Inactive placebo substance
15878037|NCT03819868|Procedure|High cost|Surfaces allocated to this group will be treated with a high-cost sealant (Fluroshield®, Dentsply, São Paulo, Brazil), according to the manufacturer's instructions.
15878038|NCT03819868|Procedure|Low Cost|Surfaces allocated to this group will be treated with a low-cost sealant (Prevent®, FGM Produtos Odontológicos, Santa Catarina, Brazil), according to the manufacturer's instructions.
15878039|NCT03819842|Diagnostic Test|Pseudophakic Measurement|standard aphakic measurements will be taken and then pseudophakic measurements will be taken after toric iol implantation. The data produced will aid the surgeon in proper placement of toric iol orientation
15878041|NCT03819816|Other|DEA-App|"The intervention (DEA) group will receive the newly developed app. DEA will consist of three simultaneous modules that provide multidimensional support for informal caregivers aiming to reduce the caregiver burden:
~Information module
~The information module consists of general information on the disease and the care of people suffering from dementia.
~Activity module
~The activity module suggests individualized activities and physical fitness exercises by a self-learning algorithm, which supports the caregiver to deliver more targeted and easier care.
~Communication module
~If two or more persons are caring for one person with dementia, the communication module provides a networking possibility."
15878042|NCT03819816|Other|Standard Information group|The control group will receive a leaflet on some general principles for promoting health and well-being in older adults with dementia.
15878043|NCT03819803|Biological|Fecal microbiota transplantation|200 ml of a tested stool suspension of a healthy donor is instilled into the patient´s caecum or terminal ileum
15878044|NCT03819790|Drug|Basal insulin glargine and lixisenatide|Soliqua (insulin glargine and lixisenatide): a titratable combination of long-acting basal insulin glargine and lixisenatide (Glucagon-like peptide-1 receptor agonist)
15878045|NCT03819790|Drug|Basal insulin Basaglar/Lantus + gliclazide MR|basal long-acting insulin Basaglar/Lantus with gliclazide MR 60 mg OD
15878046|NCT03819790|Drug|Metformin|Patients can be administered with most tolerant dose of metformin
15878047|NCT03819764|Behavioral|Aerobic Exercise|Cycling on a recumbent stationary bike with a specialized motor that forces the individual to cycle approximately 30-35% faster than your self-selected speed
15878048|NCT03819764|Behavioral|Upper Extremity Repetitive Task Practice|Repetitive arm exercises
15878049|NCT03819751|Procedure|MRI-targeted prostate biopsy|All participants receive traditional cognitive/visual registration biopsy and the above mentioned MRI/TRUS fusion biopsy (also known as software registration biopsy)
15878050|NCT03819738|Diagnostic Test|fMRI|Functional MRI will be performed in 1 scan, which will take 1.5 h. (scanning time = 30 min)
15878051|NCT03819725|Device|Glucose monitoring|FreeStyle® Libre Pro Interstitial Glucose Meter will be applied after skin preparation with anesthetic cream (Emla®) . Interstitial glucose measurements will be recorded during 2-5 days and during meals.
15878052|NCT03819712|Procedure|Collection of blood samples|23 mL of blood will be collected during the inclusion visit
15878053|NCT03819712|Other|Collection of fecal samples|Fecal sample self-collected after the inclusion visit
15878054|NCT03819712|Other|Collection of urine samples|10 mL of urine will be collected during the inclusion visit
15878055|NCT03819712|Other|Collection of vaginal swaps|Sample of vaginal microbiota collected during the inclusion visit
15878056|NCT03819699|Drug|Lu AF20513|Lu AF20513 suspension for injection
15878057|NCT03819699|Biological|booster vaccine|booster vaccine (Cohort 2) - to be administered as per national recommendations
15878058|NCT03819686|Behavioral|Living ACTS website|Living ACTS: About Choices in Transplantation and Sharing video that draws from the Information-Motivation-Behavioral Skills Model of individual level behavior change. A patient will watch the Living ACTS video (embedded in the Living ACTS website) along with any family members or friends who are accompanying a patient. Plus minimum of 5 minutes navigating the website (aside from watching ~20-minutes of videos from the website)
15878059|NCT03819686|Behavioral|Standard transplant education procedures|Review of a packet of information with the pre-transplant coordinator. The packet serves to inform transplant candidates and their families about the option living donor kidney transplantation (LDKT). In addition, participants will be provided an iPad/tablet to watch two ~10-minute National Kidney Foundation videos about kidney disease and transplantation in their private room during their regularly scheduled KT evaluation. This video discusses information about transplant, but does not specifically address LDKT and is not culturally-sensitive to African American population.
15878157|NCT03819023|Diagnostic Test|Respilife monitor|Respilife monitor
15878196|NCT03818815|Drug|Amoxicillin-clavulanate|Oral Amoxicillin-clavulanate in two divided doses for 10 days
15878060|NCT03819673|Behavioral|Intervention Group Care|children's assessment, setting weight management goals, provision of personalised meal plans, personalised diet and lifestyle optimization advice recommendations to children and their families, periodic re-evaluation every 3 or 6 months
15878061|NCT03819660|Drug|Amifampridine Phosphate 10 MG Oral Tablet|Oral tablets
15878062|NCT03819647|Drug|stiripentol (Diacomit)|Administration of stiripentol per os
15878063|NCT03819634|Device|Inset II with Lantern Technology|Each participant will insert the Inset II with Lantern technology and wear it for 10 days or until set failure and data will be collected on the cause of set failure. The infusion set will be used with their usual insulin pump.
15878064|NCT03819621|Device|IRISS Medical Technologies mediGrid app|IRISS mediGrid is standalone software, loaded on a mobile electronic platform, which is intended to record and document ophthalmic and other bodily characteristics and to aid in the diagnosis of abnormalities.
15878065|NCT03819608|Device|real iTBS|Intermittent Theta Burst Stimulation (iTBS) is a form of repetitive transcranial magnetic stimulation (rTMS), which uses short magnetic field pulses applied to the scalp to induce currents in the underlying brain. iTBS will be delivered with the Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P. The Magpro Cool Coil B65 A/P can be switched to active or placebo (A/P).
15878066|NCT03819608|Behavioral|real APT|APT-III is an attention processing training program
15878067|NCT03819608|Behavioral|placebo APT|computerized cognitive training
15878068|NCT03819608|Device|placebo iTBS|delivered with the Magventure MagProX100 with MagOption stimulator and Magpro Cool Coil B65 A/P. The Magpro Cool Coil B65 A/P can be switched to active or placebo (A/P).
15878069|NCT03819595|Other|Supervised exercise|a free 12-week, small-group (~10 people) exercise program supervised by specially trained instructors, combining two weekly 1h sessions of moderate to high intensity aerobic and strength exercise. Participants are encouraged to undertake an additional group-based walking exercise guided by target heart rates.
15878070|NCT03819595|Other|Personalized Program PVS|"a standardized promotion prescription of physical activity, balanced diet and smoking cessation, using the computer tool Promote Healthy Living integrated into the electronic medical record."
15878071|NCT03819582|Device|EyeCee One intraocular lens|Hydrophobic aspheric monofocal intraocular lens
15878072|NCT03819569|Procedure|Small Renal Mass Biopsy|Subjects will receive a small renal mass biopsy prior to making a treatment decision
15878073|NCT03819569|Other|No Small Renal Mass Biopsy|Subjects will not receive a small renal mass biopsy prior to making a treatment decision
15878074|NCT03819556|Other|Milk protein in fresh milk|Milk protein in increasing doses.
15878075|NCT03819543|Device|Transcranial Direct Current Stimulation|Application of transcranial direct current stimulation via scalp electrodes over presumed epileptogenic focus for 20 minutes at 2.0 mA.
15878076|NCT03819530|Dietary Supplement|Vitamin and Mineral Powder|Vitamin and mineral nutritional supplement. Each packet is 1g of powder, to be taken with food.
15878077|NCT03819517|Dietary Supplement|Resveratrol|Over the counter supplementation
15878078|NCT03819517|Other|Placebo|Empty white colored soft vegetarian capsule
15878079|NCT03819504|Procedure|4-D navigated stereotactic radio surgical ablation|4-D navigated stereotactic radio surgical ablation will be performed in patients with structural heart disease and sustained monomorphic ventricular tachycardia/tachycardias
15878080|NCT03819491|Dietary Supplement|COQUN ORAL FORMULATION|COQUN ORAL FORMULATION is a food supplement based on Coenzyme Q10 MINIACTIVES®
15878081|NCT03819478|Behavioral|Weight loss intervention months 0-6|All participants will undergo a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The weight loss intervention will incorporate nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions will be held weekly in a 3:1 ratio (3 group and 1 individual session per month).
15878082|NCT03819478|Behavioral|Exercise intervention months 0-6|All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the American Heart Association and the American College of Sports Medicine physical activity recommendations for older adults.
15878083|NCT03819478|Dietary Supplement|Supplement|Participants in the lower protein / higher CHO diet group (RecProt) will be provided a carbohydrate supplement (~50 g of carbohydrate and 220 calories) to consume daily during the 6 month weight loss intervention. Participants in the higher protein / lower CHO diet groups (6-mon HiProt and 18-mon HiProt) will be provided a protein supplement (~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention. Participants in the higher protein / lower CHO diet (18-mon HiProt) will be provided a protein supplement (~50 g of protein and 220 calories) to consume daily during the 12-month follow-up.
15878093|NCT03819452|Diagnostic Test|Vitamin D Level|Vitamin D level is measured upon the presentation of the case with ischemic stroke
15878195|NCT03818815|Combination Product|Placebo|Placebo 0mg per day in two divided doses for 10 days
15878094|NCT03819439|Other|Microbiome and Autism Questionnaire|The questionnaire will be administered to collect demographic data (i.e. sex, age, race, and ethnicity) of the volunteers. Additionally, it will ask for the volunteers to identify whether or not they have autism spectrum disorder and what other medical conditions they have and what medications (e.g. prescribed, over the counter, herbal; etc.) that they take.
15878095|NCT03819426|Behavioral|Low Intensity Exercise Intervention|Those in the walking intervention will be instructed to take walks below a brisk pace (low intensity) to improve mood
15878096|NCT03819426|Behavioral|High Intensity Intervention|Instructed in high intensity interval training techniques and will be provided videos to follow for implementation of intervention at home that will include short bursts of high energy
15878097|NCT03819413|Diagnostic Test|serum aquaporin 4 antibody (AQP-4-Ab)|All patients suspected to have NMOSD according to the recent diagnostic criteria will be examined for serum aquaporin 4 antibody (AQP-4-Ab) and serum myelin oligodendrocyte glycoprotein antibody (anti-MOG)
15878098|NCT03819413|Diagnostic Test|serum MOG antibody (anti-MOG)|All patients suspected to have NMOSD according to the recent diagnostic criteria will be examined for serum myelin oligodendrocyte glycoprotein antibody (anti-MOG) if they tested negative for serum aquaporin 4 antibody (AQP-4-Ab)
15878099|NCT03819413|Diagnostic Test|MRI brain, spine and orbit|All patients suspected to have NMOSD according to the recent diagnostic criteria will have MRI brain, spine and orbit with Gadolinium
15878100|NCT03819387|Drug|NBF-006|Intravenous infusion, once-weekly x 4 consecutive weeks, every 6 weeks
15878101|NCT03819361|Diagnostic Test|pulse-oximetry|Patients with suspected OSA will be monitored with 14 nights of pulse-oximetry prior to the already planned in-hospital single-night sleep study at the University Hospital Zurich
15878102|NCT03819348|Other|the multiple programs of antifungal therapy for HIV-negative host|the multiple programs of antifungal therapy for HIV-negative host TSM were compared in terms of effect on clinical remission rate, effective rate, recurrence rate, mortality and toxic side effects on HIV-negative host TSM; their prognosis and recurrence indicators were clarified, and a therapeutic effect evaluation system was established, providing a standard treatment and diagnosis scheme for clinical practice; and simultaneously the positive rate of G and GM experiments in respect of TSM, Aspergillus and other fungi was identified to provide TSM with biological diagnostic indicators.
15878103|NCT03819335|Device|mySugr app|mySugr is a mobile medical app for diabetes management. It has been developed by Roche Diabetes Care and it has two versions, free and Pro. It allows to carry out the diary of diabetes, including the collection and analysis of data on glycaemia, food, physical activity or insulin dose. In addition, it is compatible with continuous glucose measurement systems. It has the possibility to add functionalities such as estimation of HbA1c levels, more detailed data analysis or integration with Google Fit type motion sensors, as well as a bolus calculator, reminders for measuring blood glucose or photo gallery in the Pro version, which is the one that will be provided to the patients for the study.
15878104|NCT03819335|Other|Standard care|Face-to-face visits
15878105|NCT03819322|Drug|sofosbuvir/velpatasvir|12 week, oral, fixed dose
15878106|NCT03819309|Procedure|Ultrasound-guided transvaginal drainage|evacuation of the TOA will be done by ultrasound-guided transvaginal puncture under simple sedation or under general anesthesia if necessary
15878107|NCT03819309|Procedure|Laparoscopy|TOA will be evacuated by coelioscopy under general anesthesia
15878108|NCT03819296|Other|Best Practice|Receive standard of care
15878109|NCT03819296|Other|Biospecimen Collection|Undergo collection of stool, blood, and tissue samples
15878110|NCT03819296|Procedure|Endoscopic Procedure|Undergo endoscopy
15878111|NCT03819296|Procedure|Fecal Microbiota Transplantation|Undergo FMT
15878112|NCT03819296|Biological|Infliximab|Given intravenously (IV)
15878113|NCT03819296|Other|Laboratory Biomarker Analysis|Ancillary studies
15878114|NCT03819296|Drug|Prednisone|Given orally
15878115|NCT03819296|Biological|Vedolizumab|Given IV
15878116|NCT03819283|Diagnostic Test|Hepatic evaluation|Evaluation of hepatic steatosis and fibrosis by non invasive tests, either serum markers (steatotest, Fibrotest) or imaging methods (CAP, FibroScan)
15878117|NCT03819270|Drug|LY3372689|Administered orally
15878118|NCT03819270|Drug|Placebo|Administered orally
15878119|NCT03819257|Diagnostic Test|Endoanal ultrasound|For the assessment of the internal and external anal sphincter integrity. To evaluate fistulas/perianal abscess and seton placement.
15878120|NCT03819257|Diagnostic Test|High-resolution anorectal manometry|"rest - basal anal pressures at rest over 60 s
~squeeze - anal pressure during voluntary effort; long squeeze - anal pressure during sustained voluntary effort
~cough - anorectal pressure changes during cough
~push - anorectal pressure changes during simulated defecation
~rectoanal inhibitory reflex - reflex anal response to rectal distension
~rectal sensation - assessment of rectal sensitivity to distension."
15878121|NCT03819257|Diagnostic Test|Balloon expulsion test|A non-latex balloon will be inserted in the rectum after applying lubricating gel. This balloon is then filled with 50ml of warm water. The patient is ask to sit on a commode and to try to expel the device in privacy, while the time is being recorded. The test ends when the patient expelled the balloon or when 3 minutes are reach.
15878122|NCT03819244|Device|940 nm Gallium Aluminum Arsenide Diode Laser|Exposure of the cover screw of osseointegrated dental implants embedded under oral mucosa by performing the soft tissue incision with diode laser for placing the healing abutment.
15878123|NCT03819244|Device|2780 nm Er,Cr:YSGG Laser|Exposure of the cover screw of osseointegrated dental implants embedded under oral mucosa by performing the soft tissue incision with erbium laser for placing the healing abutment.
15878124|NCT03819231|Drug|Oxytocin|A single 40 IU dose of Pitocin (oxytocin, USP; concentration = 10 IU/1 mL; PAR Pharmaceuticals, NY, USA) will be self-administered to each participant. Each 40 IU dose will be transferred into four, 1 ml intranasal atomizers and will be administered in four sprays to each nostril over the course of 15 minutes.
15878125|NCT03819231|Behavioral|Mindfulness|Participants will be instructed to listen to and practice a 20-minute guided mediation each day for 7 days prior to the experimental session. The guided mindfulness practices will include body scan and seated stillness meditations.
15878126|NCT03819231|Drug|Saline Solution|A single 40mL doses of sterile saline (0.9% provided by USC pharmacy) will be transferred into four, 1 ml intranasal atomizers and will be self-administered in four sprays to each nostril over the course of 15 minutes.
15878127|NCT03819231|Behavioral|Sham mindfulness|The mindfulness sham group will be required to listen to 20-minutes of Tedtalk podcasts each day that match the attention and time of the mindfulness group. Participants will be instructed to listen to two 10-minutes segments per day in succession between lab visits while in a seated posture.
15878128|NCT03819218|Drug|MC2-01 cream|MC2-01 cream (Calcipotriene/betamethasone dipropionate, w/w 0.005%/ 0.064%)
15878129|NCT03819205|Other|kinesiotaping|The participants will receive kinesiotaping treatment on the affected side for the hemiplegic CP's and for diplegic, tetraplegic CP's the side of upper extremity which children have been used to but have obstacles in daily life for 1 week at least 2-3 hours a day, renewing if it's necessary. The participants will be also recomended dealing with the grasping and releasing activities in daily living at about 2-3 hours a day. In a way that every patient has to be the control of themselves, 1 week before kinesiotaping, immediately after kinesiotaping and 1 week after the period of kinesiotaping, patients will be evaluated with box and block test, nine hole peg test, modified house clasification and the active/passive wrist dorsiflexion range of motion
15878130|NCT03819192|Diagnostic Test|microbiome analysis|"From all full age pregnant women with PPROM enrolled in this study vaginal smear samples will be taken at three time points:
~directly after hospitalization
~5-7 days after beginning of antibiotic treatment
~24 h before birth
~The microbiome of the neonates of these women will be analysed out of pharyngeal and rectal swabs and umbilical cord blood taken directly after birth and additionally out of the first Meconium."
15878131|NCT03819192|Diagnostic Test|Conventional cultures|For every sample taken for microbiome analysis, a conventional culture is taken as control.
15878132|NCT03819192|Diagnostic Test|CAAP48 measurment|CAAP48 is an identified sepsis marker in adult patients. The samples are taken dependent on clinical monitoring to compare CAAP48 with established inflammation markers (CRP, IL-6, White blood cell count, Procalcitonin).
15878133|NCT03819179|Other|Burt's Bees Serum|This is a commercially available over-the-counter product. Ingredients: Caprylic/ Capric Trigylceride, Isopropyl Palmitate, Sweet Almond Oil, Lanette O, Water, Cetearyl Glucoside, Gluconolactone ans Sodium Benzoate, Water, Glycerin, Xanthan GUM, Tocopherol.
15878134|NCT03819179|Other|Burt's Bees Serum with Biulin|This is a commercially available over-the-counter product. Ingredients: Caprylic/ Capric Trigylceride, Isopropyl Palmitate, Sweet Almond Oil, Lanette O, Water, Cetearyl Glucoside, Gluconolactone ans Sodium Benzoate, Water, Glycerin, Xanthan GUM, Tocopherol, PreBIULIN FOS (GOVA).
15878135|NCT03819179|Other|Burt's Bees Serum with Bonicell|This is a commercially available over-the-counter product. Ingredients: Caprylic/ Capric Trigylceride, Isopropyl Palmitate, Sweet Almond Oil, Lanette O, Water, Cetearyl Glucoside, Gluconolactone ans Sodium Benzoate, Water, Glycerin, Xanthan GUM, Tocopherol, Bonicel (Ganaden).
15878136|NCT03819179|Other|Burt's Bees Serum with Berenew Complex|This is a commercially available over-the-counter product. Ingredients: Caprylic/ Capric Trigylceride, Isopropyl Palmitate, Sweet Almond Oil, Lanette O, Water, Cetearyl Glucoside, Gluconolactone ans Sodium Benzoate, Water, Glycerin, Xanthan GUM, Tocopherol, BeRenew CLR Complex (CLR).
15878137|NCT03819179|Other|Burt's Bees Serum with Ecoskin|This is a commercially available over-the-counter product. Ingredients: Caprylic/Capric Triglyceride, Dimer Dilinoleyl Dimer Dilionoleatem, Silica, Citronellyl Methylcrotonate, Tocopheryl Acetate, Xymenynic Acid, Alpha-glucan Oligosaccharide, Fragrance, Slareolide, Polymnia sonshifolia root juice, Helianthus annuus (sunflower) seed oil, Maltodextrin, Tocopherol, Beta-sitosterol, Lactobacillus, Squalene.
15878138|NCT03819166|Device|with deep touch pressure application|The deep touch pressure is applied by the weight loading devices, including but not limited to, weight blanket and weight vest.
15878139|NCT03819166|Device|without deep touch pressure application|The deep touch pressure will not be applied.
15878140|NCT03819153|Drug|Semaglutide|Participants are to inject semaglutide with a needle in the stomach, thigh or upper arm. Participants will use a pen to inject semaglutide under their skin. Participants will inject semaglutide 1 time a week on the same day of the week. Participants' dose of semaglutide will be changed over time. Participants start by taking a smaller amount (0.25 mg). After 4 weeks the dose will be increased to 0.5 mg. It will be increased more (to 1 mg) at 8 weeks. Participants will then stay on the same dose for the rest of the study.
15878141|NCT03819153|Drug|Placebo (semaglutide)|Participants are to inject placebo (semaglutide) with a needle in the stomach, thigh or upper arm. Participants will use a pen to inject placebo (semaglutide) under their skin. Participants will inject placebo (semaglutide) 1 time a week on the same day of the week. Participants' dose of placebo (semaglutide) will be changed over time. Participants start by taking a smaller amount (0.25 mg). After 4 weeks the dose will be increased to 0.5 mg. It will be increased more (to 1 mg) at 8 weeks. Participants will then stay on the same dose for the rest of the study.
15878142|NCT03819140|Drug|Yasmin|Participants in each treatment arm will receive the medication Yasmin. However only the Cyclical OCP Therapy arm will take the sugar pills designated each month in the pill packs and the Continuous OCP Therapy arm will not.
15878143|NCT03819127|Drug|Vildagliptin 50 MG Oral Tablet|
15878144|NCT03819127|Drug|Metformin Pill|
15878145|NCT03819114|Drug|Levonorgestrel Emergency Contraception (LNG EC)|LNG EC tablet(s) will be administered by mouth in a directly observed manner.
15878146|NCT03819101|Drug|Acetylsalicylic acid|100mg
15878147|NCT03819101|Drug|Atorvastatin|80 mg
15878148|NCT03819088|Dietary Supplement|Zinc|Given PO
15878149|NCT03819075|Device|Lightwalker Laser (Fotona)|For the laser group we will use a Lightwalker Laser (Fotona) with a Er:YAG 2940 nm and Nd:YAG 1064 nm wavelengths units. The laser protocol will follow the instructions of the manufacturer (TwinLight protocol) and consists of degranulation of necrotic soft tissue and bone, implant surface disinfection and creating spot bleeding in bone with Er:YAG and deep disinfection and biomodulation with Nd:YAG.
15878150|NCT03819075|Other|standard|Granulation tissue elimination, mechanical instrumentation of the implant surface and curettage of intraosseous or supracrestally bone defects will be accomplished using plastic curets, under irrigation with sterile saline solution. Cotton pellets soaked in sterile saline solution will be use to clean debris and remains of removed tissue.
15878151|NCT03819062|Device|Low Level Laser Therapy|A 3 week treatment period with 8 treatment sessions in total.
15878152|NCT03819049|Biological|ExPEC10V|Participants will receive a single IM injection of ExPEC10V (1 of 3 doses [low or medium or high]) in Cohort 1 and ExPEC10V selected dose (based on the primary analysis results of Cohort 1) in Cohort 2 on Day 1.
15888868|NCT03736616|Other|Autologous HSCT|Cellular Therapy
15878158|NCT03819010|Drug|Pre treatment Recurrence Score:18-25 Letrozole + Palbociclib|Letrozole(2,5 mg/day during 28 days of each Cycle) + Palbociclib(125mg/day during 21 days of each cycle of 28 days) as neoadjuvant treatment during 6 cycles before surgery of Breast Cancer for patients with pre-treatment recurrence Score of 18-25
15878159|NCT03819010|Drug|Pre treatment Recurrence Score:26-100 Letrozole + Palbociclib|Letrozole(2,5 mg/day during 28 days of each Cycle) + Palbociclib(125mg/day during 21 days of each cycle of 28 days) as neoadjuvant treatment during 6 cycles before surgery of Breast Cancer for patients with pre-treatment recurrence Score of 26-100
15878160|NCT03818997|Drug|DKN-01|Patient will receive DKN-01 300 mg IV every 2 weeks
15878161|NCT03818997|Drug|Atezolizumab|Patient will receive Atezolizumab 840 mg IV every 2 weeks until PD
15878162|NCT03818997|Drug|Paclitaxel|Patient will receive Paclitaxel 80 mg/m2 IV on day 1, 8 and 15 of a 28 day cycle until PD
15878163|NCT03818984|Behavioral|Safer Conception for Men with At Risk Partners|CBT based safer conception counseling with longitudinal follow-up and booster sessions. The primary outcome will be HIV RNA suppression at 6 months. Secondary outcomes include early ART uptake, adherence, serostatus disclosure, couples HIV counseling and testing uptake, and limiting unprotected sex to peak fertility.
15878165|NCT03818958|Other|blood sampling|blood sampling
15878166|NCT03818945|Drug|shofu PRG barrier coat|Trilaminar structure which forms a type of stable glass ionomer allowing ion release and recharge, while protecting the glass core from the damaging effects of moisture, greatly improving long-term durability.(Na, BO3, Al, SiO3, F,Sr)
15878167|NCT03818945|Drug|Sodium fluoride varnish|5% sodium fluoride [22,600 ppm F-]
15878168|NCT03818932|Drug|Celecoxib|Post-Operative Non Opioid Pain Protocol
15878169|NCT03818932|Drug|Hydrocodone-Acetaminophen|Traditionally used narcotic pain protocol
15878170|NCT03818932|Drug|Ketorolac|Post-Operative Non Opioid Pain Protocol
15878171|NCT03818932|Drug|Gabapentin|Post-Operative Non Opioid Pain Protocol
15878172|NCT03818932|Drug|Acetaminophen|Post-Operative Non Opioid Pain Protocol
15878173|NCT03818932|Drug|Diazepam|Post-Operative Non Opioid Pain Protocol
15878174|NCT03818919|Drug|Celecoxib|Post-Operative Non Opioid Pain Protocol
15878175|NCT03818919|Drug|Ketorolac|Post-Operative Non Opioid Pain Protocol
15878176|NCT03818919|Drug|Gabapentin|Post-Operative Non Opioid Pain Protocol
15878177|NCT03818919|Drug|Acetaminophen|Post-Operative Non Opioid Pain Protocol
15878178|NCT03818919|Drug|Diazepam|Post-Operative Non Opioid Pain Protocol
15878179|NCT03818919|Drug|Hydrocodone-Acetaminophen|Traditionally used narcotic pain protocol
15878180|NCT03818906|Procedure|Molar extraction - Control Group|The extra-oral measurements will be made for further comparison and assessment of swelling (48 hours and 7 days). Exodontia will be done in a conventional way and the evolution of the pain will be evaluated through the visual analog scale during the next 7 days.
15878181|NCT03818906|Procedure|aPDT + Molar Extraction - Test Group 1|The extra-oral measurements will be made for further comparison and assessment of swelling (48 hours and 7 days). Exodontia will be done in a conventional way and the evolution of the pain will be evaluated through the visual analog scale during the next 7 days.immediately after extraction, the fresh sockets will receive in their internal portion a local application of aPDT.
15878182|NCT03818906|Procedure|Infrared + Molar Extraction - Test Group 2|The extra-oral measurements will be made for further comparison and assessment of swelling (48 hours and 7 days). Exodontia will be done in a conventional way and the evolution of the pain will be evaluated through the visual analog scale during the next 7 days.immediately after extraction, the fresh sockets will receive local application of infrared in vestibular external portion
15878183|NCT03818906|Procedure|aPDT + Infrared + Molar Extraction - Test Group 3|The extra-oral measurements will be made for further comparison and assessment of swelling (48 hours and 7 days). Exodontia will be done in a conventional way and the evolution of the pain will be evaluated through the visual analog scale during the next 7 days.immediately after extraction, the fresh sockets will receive in their internal portion a local application of aPDT and after that will receive local application of infrared in vestibular external portion.
15878184|NCT03818893|Drug|Combination of GEN0101 and Pembrolizmub|New Combination immunotherapy GEN0101 and Pembrolizmub
15878186|NCT03818867|Procedure|Insertion of cervical cerclage|insertion of a stitch around the neck of the womb in order to provide extra support.
15878187|NCT03818854|Biological|Human Mesenchymal Stromal Cells|Immediately prior to administration, the study product will be thawed and diluted 1:1 with reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40). Additional reconstitution media is added to a final product volume of 300 mL.
15878188|NCT03818854|Biological|Cell Reconstitution Media|300 mL of reconstitution media (1:1 mix of 5% human serum albumin and 10% Dextran 40)
15878189|NCT03818841|Device|High-flow nasal cannula device|Patients will be randomly allocated to this treatment
15878190|NCT03818841|Device|Non-rebreathing oxygen mask group|Patients will be randomly allocated to this treatment
15878191|NCT03818828|Biological|TTAX01|TTAX01 is a cryopreserved human umbilical cord product derived from donated human placental tissue following healthy, live, caesarian section, full-term births after determination of donor eligibility and placenta suitability. TTAX01 is manufactured by TissueTech Inc. utilizing a proprietary CRYOTEK® process, which devitalizes the living cells but retains the natural structural and biological characteristics relevant to this tissue. TTAX01 is aseptically processed in compliance with current Good Tissue Practices (cGTP). TTAX01 will be manufactured in various sizes, stored in a medium of Dulbecco's Modified Eagle Medium/Glycerol (1:1) containing Amphotericin B.
15878192|NCT03818828|Other|Profore Compression Therapy|Subjects will utilize the compression system for the duration of the trial, with weekly re-applications of the compression system during study visits
15878193|NCT03818828|Other|Cadexomer Iodine dressing|During the 2-week Screening Run-in period, subjects should be applied cadexomer iodine on the VLU.
15878194|NCT03818815|Combination Product|OP0201|OP0201 20mg per day in two divided doses for 10 days
15888869|NCT03736616|Drug|Acalabrutinib|Bruton's Tyrosine Kinase Inhibitor
15878197|NCT03818802|Dietary Supplement|Nicotinamide Riboside|It will be administered a total of 1000 mg/day of NR in a regimen of 500mg every 12 hours by mouth for 4.5 months. After 4.5 months, an advanced individual training (AIT) will be implemented in addition to administration of 1000mg/day (500mg every 12 hours) for 6 weeks more, completing total of 6 months.
15878198|NCT03818802|Dietary Supplement|Placebo|It will be administered a correspondent placebo with the same shape and color as the active pill 12 hours by mouth for 4.5 months. After 4.5 months, an advanced individual training (AIT) will be implemented in addition to administration of correspondent placebo every 12 hours for 6 weeks more, completing total of 6 months.
15878199|NCT03818789|Behavioral|Mindfulness and acceptance training|A breathing mediation, body scan, talking about acceptance, and presence activity are used. All are low-impact and expected to cause no distress
15878200|NCT03818789|Behavioral|Study skills video|A YouTube video describing study skills and suggested habits is used as a control condition.
15878201|NCT03818776|Drug|Durvalumab|Durvalumab (MEDI4736) is an anti-PD-L1 monoclonal antibody immunotherapy for lung cancer. Participants will receive 1500mg durvalumab via intravenous (IV) infusion Q4W for up to a maximum of 12 months (up to 13 doses/cycles) with the last administration on week 48 unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. (N.b. If a participant's weight falls to 30kg (≤30 kg)), then the participant should receive weight-based dosing equivalent to 20 mg/kg of durvalumab Q4W after consultation between Investigator and Study Physician, until the weight improves to above 30 kg >30 kg, at which point the participant should start receiving the fixed dosing of durvalumab 1500 mg Q4W).
15878202|NCT03818776|Radiation|Proton beam therapy RT|Proton beam therapy is a type of RT where the proton stops at a specific depth according to its energy which allows for a sufficient tumor dose that may improve local control and survival while sparing normal organs at risk, such as the heart, lung, and spinal cord.
15878204|NCT03818750|Device|MRI|"Subjects review alcohol ads in different contexts (neutral context vs positive context such as parties and sport) and answer with buttons lever while being in the MRI to express their desire to consume alcohol or not.
~Subjects will be exposed to 288 ads set up."
15878205|NCT03818750|Behavioral|Alcohol Use Disorders Identification Test|Questionnaire
15878206|NCT03818737|Biological|Autologous Bone Marrow Concentrate (BMAC)|Bone Marrow Concentrate (BMAC) is a standard Orthobiologic injection for knee osteoarthritis.The procedure involves harvesting of bone marrow aspirate (BMA) from the posterior superior iliac spine (PSIS) and then following centrifugation in an FDA approved device (EmCyte GenesisCS Pure BMAC®-60 ml) will be injected back into the knee joint. All injections will be made via ultrasound guidance using a standard approach.
15878207|NCT03818737|Biological|Adipose-derived Stromal Vascular Fraction (SVF)|Adipose-derived Stromal Vascular Fraction will be obtained from a mini lipoaspirate. The lipoaspirate will then be enzymatically digested to produce a stromal vascular fraction (SVF) that will be injected into the knee joint. All injections will be made via ultrasound guidance using a standard approach.
15878208|NCT03818737|Biological|Umbilical Cord Tissue (UCT)|Cryopreserved doses of cord tissue MSCs will be used. These MSCs were cryopreserved at P2 culture in plasmalyte A + 5% human serum albumin in 5 finger cryobags containing 20 million cells in 4 mL and stored under liquid nitrogen until shipment. Cells will be transported in a dry shipper and thawed at the study sites. The dose of MSCs will be aspirated from the cryobag into a sterile syringe and directly injected into the knee. All injections will be made via ultrasound guidance using a standard approach.
15878209|NCT03818737|Drug|Depomedrol and Normal saline (Corticosteroid injection)|7cc of the corticosteroid injection prepared by mixing 1cc of 40mg/dL depomedrol and 6cc of normal saline in a 10cc syringe will be made into the knee joint. All injections will be made via ultrasound guidance using a standard approach.
15878210|NCT03818724|Device|CoolLoop® cryoablation system|Cryoablation of Atrial Fibrillation using the CoolLoop® Cryoablation System
15878211|NCT03818711|Behavioral|Communication & Coping Intervention|Mothers receive a treatment manual and participate in individual phone calls aimed at reducing depressive symptoms and improving the quality of parental involvement. A concurrent secret Facebook group will have daily posts to reinforce concepts.
15878212|NCT03818711|Behavioral|Education & Check Ins|Mothers receive educational materials and participate in individual phone calls related to these materials. A concurrent secret Facebook group will have daily educational posts.
15878213|NCT03818698|Other|Eplets mismatching numbers|In this study, the HLA high-resolution typing data of kidney transplant recipients from 2014 to the end of 2017 were analyzed with HLA Matchmaker for eplets mismatching number. To analyze the incidence of dnDSA and AMR after kidney transplant recipients with different eplets mismatching number posttransplant, and to elucidate the important role of tissue configuration patterns based on HLA eplets matching in long-term graft survival.
15878214|NCT03818685|Drug|Nivolumab|Radiotherapy will be maintained in each Arm.
15878215|NCT03818685|Drug|Ipilimumab|Radiotherapy will be maintained in each Arm.
15878216|NCT03818685|Drug|Capecitabine|Radiotherapy will be maintained in each Arm.
15878217|NCT03818672|Drug|Rifaximin|Rifaximin 550 MG BID
15878251|NCT03818282|Drug|Paclitaxel for injection (albumin-bound)|Paclitaxel for injection (albumin-bound) 260 mg/m2, i.v., d1; AUC = 5 for carboplatin injection, i.v., infusion completed on day 1-3; Repeated every 3-4 weeks for 6-8 cycles.
15878252|NCT03818269|Procedure|Subcutaneous pressure measurement|Subcutaneous interstitial measurement at D1 and D2
15878220|NCT03818646|Diagnostic Test|Functional Respiratory Imaging|Functional Respiratory Imaging (FRI) is a novel image based functional diagnostic tool that combines high-resolution CT scans (HRCT) at TLC and FRC with flow simulations (computational fluid dynamics - CFD) providing a 3D visualization and quantification of lung structure and function.
15878221|NCT03818633|Device|Elastic abdominal binder|Each woman in the intervention group is fitted with an elastic abdominal binder at the time of procedure completion just before leaving the operating room. The binder is placed snuggly tight (keeping in mind patient's comfort) on top of the hospital gown with the incision positioned at the middle part of the binder. The patients are encouraged to wear binders at all time. However, periods of break from wearing the binder are allowed at their convenience.
15878222|NCT03818620|Device|Barco digital dermatoscope device images|Images of skin lesion taken with the Barco dermatoscope by site team member
15878223|NCT03818620|Device|Reference standard dermatoscope device images|Images of skin lesion taken with a standard dermatoscope device (as part of standard care)
15878224|NCT03818607|Drug|ABP 959|intravenous infusion
15878225|NCT03818607|Drug|Eculizumab|intravenous infusion
15878226|NCT03818581|Drug|Suvorexant|10-mg or 20-mg Suvorexant capsules
15878227|NCT03818581|Other|Placebo|Matching placebo capsules
15878228|NCT03818568|Dietary Supplement|ketoanalogues of essential amino acids|Patients will receive conventional treatment according to the institution's clinical guidelines, with moderate restriction of proteins 0.6 g protein/kg/day, as recommended to slow renal damage progression), plus ketoanalogues in the established dosage (1 tablet/5 kg weight divided into 3 doses per day).
15878229|NCT03818555|Other|Sebacia Microparticles Treatment|Sebacia Microparticles procedure involving microparticles and 1064 nm laser. Three treatment procedures over a two-week period.
15878230|NCT03818542|Drug|ABBV-181|intravenous infusion
15878231|NCT03818542|Drug|ABBV-368|intravenous infusion
15878232|NCT03818542|Drug|ABBV-927|intravenous infusion
15878233|NCT03818542|Drug|ABBV-927|intratumoral injection
15878234|NCT03818516|Other|Oral Glucose Tolerance Test (OGTT)|Participants will undergo a fasting blood draw for inflammatory and metabolic markers before a 75gm oral glucose tolerance test (OGTT) and at 1, 2 and 3 hours post-OGTT. Behavioral assessments will also be administered pre- and post-OGTT administration.
15878235|NCT03818490|Other|Bergamot Aromatherapy|Patients in this group inhaled bergamot essential oil for 15 minutes.
15878236|NCT03818451|Dietary Supplement|Co-ultraPEALut (Glialia)|Co-ultraPEALut is administered to moderate traumatic brain injured patients for 180 days
15878237|NCT03818412|Procedure|Archival tumor tissue collection and blood draws|Archival tumor tissue will be collected for testing of circulating tumor DNA. Blood draws will be taken for testing of circulating tumor DNA.
15878238|NCT03818399|Drug|SUBLOCADE|SUBLOCADE (buprenorphine extended-release) injection is a colorless to amber sterile solution for SC injection designed to deliver buprenorphine at doses of 100 mg or 300 mg at a controlled rate over a one-month period.
15878239|NCT03818386|Drug|AGuIX®|"3 intravenous injection at 100mg/kg
~D0: AGuIX® injection followed by MRI (within 7 days before commencement of WBRT)
~Fr1: AGuIX® injection before the first radiation session
~Fr6: AGuIX® injection before the sixth radiation session"
15878240|NCT03818386|Radiation|Whole Brain Radiation Therapy|30 Gy in 10 fractions of 3 Gy over 2-3 weeks
15878241|NCT03818373|Procedure|polysomnography|Sleep examination strictly non-invasive with skin sensors. This exploration would allow for the detection of respiratory sleep disorders and consider of appropriate management for patients.
15878243|NCT03818347|Device|oxyhydrogen generator (AMS-H-03)|Rated gas output (L) : 3L/min, concentration of hydrogen and the oxygen was 66.6% and 33.3%, respectively. The patients inhale 3 hours each day through a cannula or mask, and persist for long term
15878244|NCT03818347|Device|analogue machine|This machine has the same apperance and gas condition
15878245|NCT03818334|Drug|Cyclophosphamide|Cyclophosphamide 1000 mg/flask
15878246|NCT03818334|Drug|ATG|Antihuman T-Lymphocyte Immune Globulin 25 mg/flask
15878247|NCT03818321|Drug|Methenamine Hippurate 1 g tablet|Methenamine Hippurate (study drug) is an FDA approved medication in the prevention of UTI. Methenamine Hippurate 1g contains Hippuric acid salt of Methenamine (hexamethylene tetramine), Magnesium Stearate, Povidone, Saccharin Sodium, FD&C Yellow No. 5 (tartrazine) (www.iodine.com/drug/hiprex/fda-package-insert).
15878248|NCT03818321|Drug|Placebo tablet|Placebo is a tablet that will be provided to you that looks like the study drug but does not contain any medication. These pills are comprised of gelatin and minimal amounts of lactose powder. The pills are designed to have no effect on the patient.
15878249|NCT03818308|Drug|Sofosbuvir and Velpatasvir|All subjects will receive one film-coated tablet of sofosbuvir/velpatasvir (400/100 mg) orally once daily for 8 weeks.
15878250|NCT03818295|Drug|[14C]-praliciguat|10 mg praliciguat containing approximately 500 μCi of [14C]-praliciguat
15878254|NCT03818256|Drug|Miricorilant|Placebo tablets for once daily oral dosing
15878255|NCT03818243|Behavioral|Diary (for reporting all impulse control disorders especially compulsive eating disorders)|During 7 days, at home, patients must report in their diary all their impulse control disorders especially their compulsive eating disorders. They will detailed each food intake and drink intake and the time.
15878256|NCT03818230|Other|None (observational study)|None (observational study)
15878257|NCT03818217|Device|Coach Pepper group|"Robot Pepper's height is 1.20 meters and it weighs 28 kilograms. Pepper's operation time is about 12 hours.
~Pepper will be called as Coach Pepper because s/he is virtually connected via web interfaces with a theratainment app including cognitive and physical training ."
15878258|NCT03818217|Device|Tablet group|The Tablet provides a theratainment app including cognitive and physical training.
15878259|NCT03818204|Device|Magnetic Levator Prosthesis (MLP)|Neodymium magnet embedded in a glasses frame and a polymer embedded (PDMS) micro-magnet array fitted externally to the upper lid with IV 3000 securement film. The IV 3000 is FDA approved for extended wear on the skin. Tegaderm, which is essentially the same adhesive, is even FDA approved as an eye covering (we used Tegaderm in early studies but switched to IV 3000 for its superior ease of handling based on packaging technique).
15878260|NCT03818191|Drug|Acamprosate|The research pharmacy contracted for this study will randomize the study participants for all sites with placebo or acamprosate.
15878261|NCT03818191|Other|Placebo|The research pharmacy contracted for this study will randomize the study participants for all sites with placebo or acamprosate.
15878262|NCT03818178|Dietary Supplement|Intralipid|Half of the participants will receive either naso-duodenal infusion of intralipid or palm oil each participant will serve as their own saline control on the second study day.
15878263|NCT03818178|Dietary Supplement|Palm Oil Emulsion|Half of the participants will receive either naso-duodenal infusion of intralipid or palm oil each participant will serve as their own saline control on the second study day.
15878264|NCT03818178|Other|Saline|All participants will serve as their own controls with a saline infusion study day.
15878265|NCT03818165|Biological|CAR2 Anti-CEA CAR-T cells|doses will be delivered by hepatic arterial infusions using pressure enhanced delivery device (PEDD)
15878266|NCT03818152|Other|Functional strength assessment|Functional strength exercises to assess strength in lower limbs.
15878267|NCT03818139|Other|radiography thorax|The ultrasound of the thorax will be performed while waiting for the X-ray thorax
15878268|NCT03818126|Drug|del Nido cardioplegia|"The del Nido components are: Plasma-Lyte A (1000ml), Mannitol 20% (16.3ml), MgSO4 50% (4ml) , NaHCO3 8.4% (13ml) , KCl 2mEq/mL (13ml), Lidocaine 1% (13ml). This solution is mixed with autologous patient blood from the cardiopulmonary circuit in a 4:1 ratio (crystalloid:blood).
~The dosage is 20ml/kg. The target administration pressure is 100-200mmHg and the target administration flow is 200-300ml/min. The solution temperature is 4 degrees Celsius. Additional dose of the cardioplegia is given only if the cross-clamp time exceeds 90 minutes. Due to high volume given in a single delivery, 40 milligrams of furosemide are injected into cardiopulmonary circuit."
15878269|NCT03818126|Drug|cold blood cardioplegia|"The cold blood cardioplegia components are: Plasma-Lyte A (435ml), Mannitol 15% (20ml), NaHCO3 8.4% (20ml), KCl 2mEq/mL (25ml). The solution is mixed with autologous patient blood from the cardiopulmonary circuit in a 1:4 ratio (crystalloid:blood).
~The initial dose is 15ml/kg and a dose of 5ml/kg is added every 20-30 minutes or whenever cardiac activity is observed. The target administration pressure is 100-200mmHg and the target administration flow is 200-300ml/min. The solution temperature is 4 degrees Celsius."
15878270|NCT03818113|Other|cardioplegia with HTK-Bretschneider cardioplegic solution|cardioplegia with HTK-Bretschneider cardioplegic solution
15878271|NCT03818113|Other|cardioplegia with St. Thomas cardioplegic solution|cardioplegia with St. Thomas cardioplegic solution
15878272|NCT03818100|Radiation|Intensity modulated radiotherapy (IMRT)|Simultaneous integrated boost technique using IMRT: 48 Gray (Gy) and 40 Gy will treat tumour and breast tissue respectively, in 15 fractions over 3 weeks.
15878273|NCT03818100|Drug|Endocrine therapy|Endocrine therapy will commence following completion of radiotherapy, and will continue for 20 weeks.
15878274|NCT03818100|Procedure|Breast conserving surgery|Surgery carried out using local protocol following completion of endocrine therapy.
15878275|NCT03818087|Behavioral|Observational cohort|Patients will be followed by collecting clinical data, biospecimens, and quality of life assessments over a period of five years from registration.
15878276|NCT03818074|Device|Boston Wavewriter 1000Hz Spinal cord Stimulation|High frequency spinal cord stimulation.
15878277|NCT03818061|Drug|Atezolizumab|Patients will receive the combination of Atezolizumab 1200 mg and Bevacizumab 15 mg/kg by IV infusion every 3 weeks.
15878278|NCT03818061|Drug|Bevacizumab|Patients will receive the combination of Atezolizumab 1200 mg and Bevacizumab 15 mg/kg by IV infusion every 3 weeks.
15878279|NCT03818048|Drug|Propofol|after inicial bolus of propofol, remained sedated with propofol infusion (1-2 mg/kg/min)
15878280|NCT03818048|Drug|Sevoflurane|after inicial bolus of propofol, remained sedated by inhalation with sevoflurane at a concentration of 2 vol% through a nasal cannula with an oxygen flow.
15878283|NCT03818022|Procedure|Cryoneurolysis (Iovera)|Cryoneurolysis performed by radiology department 1 week prior to total knee arthroplasty
15878284|NCT03818009|Other|Assessment document|The anesthesiologist will evaluate through his sheet women's cognitive functions.
15878285|NCT03817996|Other|Fluid challenge|250ml of saline in Responders (those who increased >10% their cardiac output after a passive leg raising maneuver).
15878286|NCT03817983|Diagnostic Test|MRE review for axSpA|Screening for evidence of axSpA on the MRE scan of patients with Crohn's disease followed by clinical and MRI assessment
15878287|NCT03817970|Drug|Granisetron|An antiemetic regimen containing granisetron 2 mg oral or IV.
15878288|NCT03817970|Drug|Ondansetron|An antiemetic regimen containing ondansetron 8 mg oral or IV.
15878289|NCT03817970|Drug|Palonosetron|An antiemetic regimen containing palonosetron 0.25 mg IV.
15878294|NCT03817931|Drug|Beta-3 Agonists, Adrenergic|Tablet taken once daily.
15878295|NCT03817931|Diagnostic Test|Functional magnetic resonance imaging (fMRI)|All subjects have fMRI at baseline and again after 30 days
15878296|NCT03817931|Diagnostic Test|Rey Auditory Verbal Learning Test (RAVLT)|All subjects have RAVLT at baseline and again after 30 days. RAVLT evaluates: short-term auditory-verbal memory, rate of learning, learning strategies, retroactive, and proactive interference, presence of confabulation of confusion in memory processes, retention of information, and differences between learning and retrieval.
15878297|NCT03817918|Procedure|Lung ultrasonography|Patients undergoing thoracic surgery under general anesthesia using one-lung ventilation will have lung ultrasonography at 2 predetermined sites at four different time points
15878298|NCT03817905|Other|Patient navigator|Intervention will utilize staff at the Seidman Cancer Center who are trained in patient navigation and have experience in navigating patients for breast cancer screening as well as sickle cell disease. The staff will undergo training for this study by study principal investigators which will include the target participant population, necessary steps in the navigation process and data that will be collected. In addition, they will receive brief training in supportive, listening technique. They will also be furnished with a telephone script for the initial participant contact.
15878299|NCT03817892|Other|Guidance of the External Chest Compression|The CPRmeter® device is positioned on the patient's chest with a disposable adhesive. In the situation of guidance of the External Chest Compression the rescuers have access in real time on the screen to visual feedback on the quality of the External Chest Compression performed and indications of possible corrections to improve the quality of the External Chest Compression . In the case of non-guidance of the External Chest Compression , a mask is position on the screen in order to hide the feedback information.
15878300|NCT03817892|Other|Rhythm of a relay 4 minutes|The duration or rhythm of a relay is the time during which a rescuer performs External Chest Compression before being relayed by another rescuer. This time is 2 minutes in non intervention group according to the current guidelines and 4 minutes in experimental group.
15878301|NCT03817879|Procedure|VivaSight double-lumen tube for single-lung ventilation|Procedure using a tube with a camera
15878302|NCT03817879|Procedure|Conventional double-lument tube for single-lung ventilation|Procedure using a tube without a camera
15878303|NCT03817866|Diagnostic Test|BRAHMS CgA II KRYPTOR|"The BRAHMS CgA II KRYPTOR kit is an automated immunofluorescent assay for the quantitative determination of the concentration of CgA in human serum.
~The assay is to be used as an aid in monitoring disease progression during the course of disease and treatment in patients with GEP-NETs (grade 1 and grade 2).
~Serial testing for patient BRAHMS CgA II KRYPTOR assay values should be used in conjunction with other clinical methods for monitoring GEP-NETs (grade 1 and grade 2)."
15878310|NCT03817840|Procedure|Treatment of Cushing's|Surgical resection of ACTH-secreting tumor to achieve cure of hypercortisolism
15878311|NCT03817827|Other|Acupuncture|this group will receive Acupuncture for 30 minutes three times per week
15878312|NCT03817827|Dietary Supplement|Diet supplementary|Diet supplementary with soy product
15878314|NCT03817801|Device|NSE balloon|NSE (Goodman®) predilation + DCB (Sequent® Please) treatment
15878315|NCT03817801|Device|NC balloon|NC balloon predilation + DCB (Sequent® Please) treatment
15878316|NCT03817788|Drug|polyethylene glycol|All patients should receive dietary guidance, and eat a low-residue diet three days before colonoscopy. For polyethylene glycol group (group P): the day before colonoscopy, 750 mL (1 box) of polyethylene glycol solution should be drunk 2 hours after dinner; the other 1500 ml (2 boxes) of polyethylene glycol solution should be taken 4-6 hours before the examination. After oral laxatives were finished, 20 ml dimethicone would be taken orally as defoamer. All the enteroscopy should by performed by the same juniar clinician, and related indicators were recorded.
15878317|NCT03817788|Drug|sodium phosphate|All patients should receive dietary guidance, and eat a low-residue diet three days before colonoscopy. For sodium phosphate group (group S), 750 mL (1 box) of sodium phosphate solution should be drunk 2 hours after dinner; and the other 750 mL (1 box) of sodium phosphate solution should be taken 4-6 hours before the examination. After oral laxatives were finished, 20 ml dimethicone would be taken orally as defoamer. All the enteroscopy should by performed by the same clinician, and related indicators were recorded.
15878318|NCT03817775|Other|Music therapy|"The intervention group will administer U sequence between 10 minutes prior to the beginning of the procedure until its end."
15878319|NCT03817749|Dietary Supplement|Exogenous ketone monoester|Participants will consume 20g of the oral ketone monoester supplement 15 minutes prior to each meal of the day for 14 days. All meals will be provided throughout the 14-day supplementation period.
15878320|NCT03817736|Procedure|TACE|Procedure of TACE will be standardized.
15878321|NCT03817736|Radiation|SBRT|SBRT screening and planning will be performed by radiation therapists, medical physicists, and oncologists.
15878322|NCT03817736|Drug|Immune Checkpoint Inhibitor|An immune checkpoint inhibitor may be administered up to 3 days before or after the scheduled day of administration of each cycle due to administrative reasons.
15878323|NCT03817723|Radiation|c-arm cholangiography|
15878324|NCT03817697|Other|Questionnaire|The socio-demographic characteristics of patients, their current and past drug use as well as their knowledge of hepatitis B and vaccination, will be collected via a questionnaire, conducted by the service's addictologists at the beginning of the consultation.
15878325|NCT03817684|Drug|BPN14770|Drug BPN14770
15878326|NCT03817684|Drug|Placebo|Placebo
15878327|NCT03817671|Other|5% O2|Culturing embryos in 5% O2 just after thawing and till embryo transfer
15878328|NCT03817671|Other|2% O2|Culturing embryos in 2% O2 just after thawing and till embryo transfer
15878329|NCT03817658|Drug|SHR-1210|"First stage：
~Concurrent chemoradiotherapy:
~Cisplatin：25-30mg/m2 ivgtt d1;Capecitabine：800mg/m2, bid d1-5，qw，5weeks；Synchronous radiotherapy：1.8-2Gy/d，5d/W，45-50Gy。 Consolidation treatment： Cisplatin： 60-75mg/m2 ivgtt d1 Capecitabine：1000mg/m2, bid d1-14，q3w 6weeks。
~Second stage:
~SHR-1210 was administered intravenously (no prophylactic use), a fixed dose of 200 mg, and 3 mg/kg for subjects with a baseline weight <50 kg. Each infusion for 30 min (not less than 20 min, no more than 60 min), once every 2 weeks, 1 cycle every 4 weeks, the cumulative longest medication period is 12 months."
15878330|NCT03817658|Drug|Placebo|"First stage：
~Concurrent chemoradiotherapy:
~Cisplatin：25-30mg/m2 ivgtt d1;Capecitabine：800mg/m2, bid d1-5，qw，5weeks；Synchronous radiotherapy：1.8-2Gy/d，5d/W，45-50Gy。 Consolidation treatment： Cisplatin： 60-75mg/m2 ivgtt d1 Capecitabine：1000mg/m2, bid d1-14，q3w 6weeks。
~Second stage:
~Placebo was administered intravenously (no prophylactic use), a fixed dose of 200 mg, and 3 mg/kg for subjects with a baseline weight <50 kg. Each infusion for 30 min (not less than 20 min, no more than 60 min), once every 2 weeks, 1 cycle every 4 weeks, the cumulative longest medication period is 12 months."
15878331|NCT03817645|Other|Zeolite|The natural zeolite clinoptilolite is of volcanic origin. The mineral belongs to the group of zeolite minerals. Zeolites are silicates with a microporous structure. This results in a stable structure with nanometer-sized cavities that pass through the natural zeolite clinoptilolite - comparable to a mineral sponge. Due to the numerous pores and channels, the mineral has a large internal surface and it can absorb molecules that are smaller in diameter than the pore openings. Since zeolite clinoptilolite has an anionic charge, there are cations such as Na +, K +, Ca 2+, Mg 2+ which can be exchanged for other ions (e.g., Pb^2+) in the cavities for electrical charge balance. In particular, the ion exchange capacity is essential for the effect and is used in many areas.
15878332|NCT03817632|Device|Computer assisted primary total knee replacement with OrthoPilot FS101 navigation system and Software 5.1|Computer Assisted Total Knee Replacement with the OrthoPilot FS101 and the software TKA 5.1
15878333|NCT03817632|Device|Computer assisted primary total knee replacement with OrthoPilot Elite navigation system and Software 6.0|Computer Assisted Total Knee Replacement with the with the OrthoPilot Elite and the software TKA 6.0
15878334|NCT03817619|Drug|Zepatier whole tablet|Single-dose ELB/GZR as a whole tablet in a fasted state.
15878335|NCT03817619|Drug|Zepatier crushed tablet|Single-dose crushed ELB/GZR in a fasted state.
15878336|NCT03817606|Device|Tritanium Posterior Lumbar Cage|Placement of Tritanium Posterior Lumbar Cage via TLIF procedure
15878337|NCT03817606|Device|AVS UniLIF PEEK Posterior Lumbar Cage|Placement of AVS UniLIF PEEK Posterior Lumbar Cage via TLIF procedure.
15878338|NCT03817593|Other|Transcendental Meditation (TM)|Each participant will have an individual instruction for 1 hour, followed by a course of 3 weekly group meetings (1-1.5 hours) The students shall meditate in a group for 10 minutes, twice a day, during 3 months, under the supervision of school teachers who will be instructed in TM technique.
15878342|NCT03817567|Drug|recombinant anti-EGFR monoclonal antibody|Experimental: Recombinant Anti-EGFR Monoclonal Antibody（SCT200）. Initially, SCT200 6.0mg/kg will be administered at day 1 every week for a maximum of 6 cycles. After 6 cycles SCT200 8.0mg/kg will be administered at day 2 every weeks until disease progression.
15878343|NCT03817554|Drug|Pramipexole|Pramipexole will be taken once daily in the evening 2 to 3 hours before bedtime. The starting dose of pramipexole is 0.125 mg/day. During the first 4 weeks, the daily dose could be increased by the treating physician in weekly intervals to 0.25, 0.50, or 0.75 mg/day, according to the Patient Global Impression scale (PGI) rating and overall tolerability of the drug. In the case of adverse events (AEs), the dose could be reduced to the previous dose step. During 5 to 12 weeks, the dose will keep constant.
15878344|NCT03817554|Other|placebo|Placebo will be taken once daily in the evening 2 to 3 hours before bedtime. The starting dose of placebo is 0.125 mg/day. During the first 4 weeks, the daily dose could be increased by the treating physician in weekly intervals to 0.25, 0.50, or 0.75 mg/day, according to the Patient Global Impression scale (PGI) rating and overall tolerability of the drug. In the case of adverse events (AEs), the dose could be reduced to the previous dose step. During 5 to 12 weeks, the dose will keep constant.
15878345|NCT03817541|Device|Edmon (reg), BBraun|exhaled propofol will be compared With plasma propofol values
15878346|NCT03817528|Drug|ITI-007|ITI-007 (Lumateperone tosylate)dosed 40-60 mg based on efficacy/adverse events
15878347|NCT03817515|Drug|ABI-009|Sirolimus Albumin-bound Nanoparticles
15878348|NCT03817502|Drug|Cariprazine|Cariprazine capsules, oral administration, once daily.
15878349|NCT03817502|Drug|Placebo|Matching placebo capsules, oral administration, once daily.
15878350|NCT03817489|Behavioral|Baduanjin qigong|The intervention consists of eight sequential forms of movements which is practiced with guidance on rhythmic breathing and mindful awareness. Each cycle of the eight movements requires 10 to 15 minutes for completion. Four cycles will be practiced in each session with short breaks arranged between them.
15878392|NCT03817229|Behavioral|Individualized Adherence Feedback Report|Individual Adherence Feedback reports sent to parents weekly
15878467|NCT03816696|Drug|DTG|DTG will be available as 50 mg tablets. Subjects will be administered DTG 50 mg QD via the oral route.
15878589|NCT03815669|Procedure|Arthroscopic subacromial decompression|Arthroscopic subacromial decompression
15878351|NCT03817489|Behavioral|Mindfulness meditation|The intervention is developed based on the core components of the established Mindfulness-Based Stress Reduction and the Mindful Self-Compassion program with adaptation for local practice. The focus of the group is to nurture mindful awareness, acceptance, and self-compassion. The group sessions are composed of a combination of mindfulness-based practice, relaxation, and yoga exercise. The basic philosophy of this intervention is the emphasis of the nurturing of self-kindness attitude, and non-attachment attitude towards inter-personal connectedness and letting go of self-criticism, need for control, and defensive separation in times of adversity. Short breaks will be arranged between each practice.
15878352|NCT03817476|Drug|BI 425809 (Treatment T1)|Intended commercial formulation tablet from batch 1 (iCF1)
15878353|NCT03817476|Drug|BI 425809 (Treatment T2)|Intended commercial formulation tablet from batch 2 (iCF2)
15878354|NCT03817476|Drug|BI 425809 (Treatment R)|Trial formulation 2 tablet (TF2)
15878357|NCT03817450|Behavioral|Daily Mouth Care|Nursing assistants will be trained to provide daily mouth care to all residents in nursing homes. Mouth care supplies will also be provided to intervention nursing homes.
15878358|NCT03817424|Drug|VIB7734|Participants will receive VIB7734 via injection.
15878359|NCT03817424|Drug|Placebo|Participants will receive placebo matching to VIB7734 via injection.
15878360|NCT03817411|Drug|Telatinib|300 mg tablets, 900 mg twice daily (BID) at 12h-intervals.
15878361|NCT03817411|Drug|Capecitabine|1000 mg/m²,twice daily for 14 days followed by a 7-day rest period (14 days on/7 days off schedule).
15878362|NCT03817411|Drug|Oxaliplatin|130 mg/m2, administered intravenously over 2 hours, on Day 1 every 3 weeks (one administration per cycle) for a maximum of 6 cycles.
15878363|NCT03817411|Drug|Placebos|300 mg tablets, 900 mg twice daily (BID) at 12h-intervals.
15878364|NCT03817398|Procedure|Biospecimen Collection|Undergo blood collection
15878365|NCT03817398|Other|Drug Withdrawn|Stop taking TKI medication
15878366|NCT03817398|Other|Quality-of-Life Assessment|Ancillary studies
15878367|NCT03817398|Other|Questionnaire Administration|Ancillary studies
15878368|NCT03817398|Drug|Tyrosine Kinase Inhibitor|Re-start TKI medicaiton
15878369|NCT03817385|Device|repetitive TMS|rTMS x 10 times
15878370|NCT03817385|Device|robotic GT|robotic gait training for 20 times
15878371|NCT03817372|Device|Anterior-posterior electrode position|Escalating energy shocks (100 J, 150 J, 200 J, 360 J) using anterior-posterior electrode position
15878372|NCT03817372|Device|Anterior-lateral electrode position|Escalating energy shocks (100 J, 150 J, 200 J, 360 J) using anterior-lateral electrode position
15878373|NCT03817359|Combination Product|Remifentanil-propofol mixture|Participants receive total intravenous anesthesia with remifentanil-propofol mixture by single TCI pump in intervention group. All TCI target concentration adjustments or extra bolus of propofol or remifentanil during operation were based on BIS and ANI monitor.
15878374|NCT03817346|Drug|GT-002|Single ascending dose
15878375|NCT03817346|Drug|Placebo oral capsule|Comparator single ascending dose
15878376|NCT03817320|Drug|Ixazomib|"Days 1, 4, 8, and 11. Note: at least 72 hours must have elapsed between doses
~Dose Phase 1 - Assigned upon study entry.
~Phase 2 - PO formulation at RP2D"
15878377|NCT03817320|Drug|Vincristine|"IV push over 1 minute or infusion via minibag as per institutional policy
~Days 1, 8, 15 and 22
~Dose: ≥ 1 year: 1.5mg/m2/dose (maximum dose 2mg)
~≥ 6 months and < 1 year: 1.2mg/m2/dose
~< 6 months: 1mg/m2/dose"
15878378|NCT03817320|Drug|Dexamethasone|"Days 1-14
~Dose: ≥ 1 year: 10mg/m2/day, divided BID (i.e., 5mg/m2/dose, BID)
~≥ 6 months and < 1 year: 8mg/m2/day, divided BID (i.e., 4 mg/m2/dose, BID)
~< 6 months: 7mg/m2/day, divided BID (i.e., 3.5 mg/m2/dose, BID)"
15878379|NCT03817320|Drug|Asparaginase|"Days 2, 15
~Dose ≥ 1 year: 2,500 International units (IU)/m2/dose
~≥ 6 months and < 1 year: 2,000 IU/m2/dose
~< 6 months: 1,750 IU/m2/dose
~Patient with allergic reaction to Pegaspargase can be given Erwinase IM/IV on Mon/Wed/Fri (or every other day per institutional standard) x 6 doses for each dose of Pegaspargase.
~Dosing guideline for Erwinase:
~1 year: 25,000 IU/m2/dose
~6 months and < 1 year: 20,000 IU/m2/dose
~< 6 months: 17,500 IU/m2/dose"
15878380|NCT03817320|Drug|Doxorubicin|"Day 1
~Dose ≥ 1 year: 60mg/m2/dose
~≥ 6 months and < 1 year: 48 mg/m2/dose
~< 6 months: 42mg/m2/dose"
15878381|NCT03817307|Diagnostic Test|USPIO-enhanced MRI|The USPIO contrast agent will be administered intravenously to the subjects. An MRI scan of the neck region is performed 24-36 hours later to detect lymph node metastases.
15878382|NCT03817294|Other|Comparison of exercise training modalities|As above
15878383|NCT03817281|Device|Accuryn Monitoring System|The Accuryn Monitoring System is a novel Foley catheter and monitoring device capable of detecting physiologic changes in vital signs via sensors within the catheter system. These data are captured non-invasively, continuously, and at a high frequency.
15878384|NCT03817268|Drug|Capecitabine monotherapy|Capecitabine is administered within 6 weeks after resection and after adequate recovery. To reduce the side effects and improve patient compliance, the administered dose is half of the recommendation: 625 mg/m2, bis in die (BID) (1250 mg/m2 per day). A 2-week therapy is followed by a 1-week pause, and a cycle includes 3 weeks. A total of 8 cycles is planned for each patient.
15878385|NCT03817255|Other|Substance use questionnaire|Questions about substance use based on the Detection of Alcohol and Drug Problems in Adolescents (DEP-ADO) survey.
15878386|NCT03817255|Other|Physical activity|Questions about physical activity, based on the short version of the International Physical Activity Questionnaire (IPAQ).
15878387|NCT03817242|Procedure|Tympanoplasty using tragal cartilage graft|tympanoplasty type I is performed using tragal cartilage in arm 1
15878388|NCT03817242|Procedure|Tympanoplasty using temporalis fascia graft|tympanoplasty type I is performed using temporalis fascia in arm 2
15878389|NCT03817229|Behavioral|Education microlearning sessions|mHealth education microlearning sessions
15878390|NCT03817229|Behavioral|Automated digital reminders|reminders from electronic monitors based on texts or lights/chimes
15878391|NCT03817229|Behavioral|Problem-solving mHealth module|mhealht problem solving module with 2 telehealth sessions with a therapist
15878393|NCT03817216|Device|Prostatic Urethral Lift (PUL)|PUL/ UroLift® is an FDA-approved device for the treatment of obstructive symptoms due to benign prostatic hyperplasia (BPH). This study evaluates UroLift's efficacy participants with obstructive symptoms who are candidates for radiotherapy or those who developed obstructive symptoms after radiotherapy.
15878394|NCT03817203|Other|Kinesio tape application|Kinesio tape application combined with pelvic floor exercises will be performed.Taping is carried out for 2 days/week in 6 weeks. The exercise program is performed every day for 6 weeks
15878395|NCT03817203|Other|Sham tape application|Sham tape application combined with pelvic floor exercises will be performed.Sham taping is carried out for 2 days/week in 6 weeks. The exercise program is performed every day for 6 weeks
15878396|NCT03817190|Drug|DS107|DS107 Capsule
15878397|NCT03817190|Drug|Placebo|Placebo capsule
15878398|NCT03817177|Procedure|high flow nasal cannula oxygenation|high flow nasal cannula application in PACU
15878399|NCT03817177|Procedure|nasal prong|conventional nasal prong application in PACU
15878400|NCT03817164|Device|Autonomic Nerve Modulation - Active|Thync ANM is a portable, battery-powered, electrical neuromodulation device connected to single-use gel electrode pads that are applied to the base of the neck.
15878401|NCT03817164|Device|Autonomic Nerve Modulation - Control|Thync ANM is a portable, battery-powered, electrical neuromodulation device connected to single-use gel electrode pads that are applied to the base of the neck.
15878402|NCT03817151|Procedure|posterior chamber intraocular lens implantation|patients who underwent transscleral sutured posterior chamber intraocular lens implantation
15878403|NCT03817138|Other|Exposures: Markers of disease progression|From early phases of the study, it is expected that six main domains will be assessed which will include over N=100 potential markers reflecting different markers of dementia disease progression identifiable from patients' primary care EHR.
15878404|NCT03817125|Drug|Placebo for antibiotic|Placebo for antibiotic will be administered orally four times a day for 4 days, followed by a 2-3 day washout.
15878405|NCT03817125|Drug|Vancomycin pretreatment|Vancomycin (125mg) will be administered orally four times a day, followed by a 2-3 day washout.
15878406|NCT03817125|Drug|Nivolumab|Nivolumab (480 mg) will be administered intravenously (IV) according to institutional guidelines every 4 weeks for up to 12 cycles. A cycle is defined as 4 calendar weeks.
15878407|NCT03817125|Drug|Matching Placebo for SER-401|Administered once a day for 7 days during the lead-in phase, followed by once a day for 8 weeks during the microbiome/anti-PD-1 treatment phase.
15878408|NCT03817125|Drug|SER-401|Administered once a day for 7 days during the lead-in phase, followed by once a day for 8 weeks during the microbiome/anti-PD-1 treatment phase.
15878409|NCT03817112|Drug|Dexmedetomidine Hydrochloride 0.1 MG/ML|Dexmedetomidine Hydrochloride 0.1 MG/ML infusion at 0.2-0.7 mcg/kg/min
15878410|NCT03817112|Drug|Propofol 10 MG/ML|Propofol 10 MG/ML infusion at 0.3 -4 mg/kg/h
15878411|NCT03817099|Other|Nutrition Intervention based on My Dia-RNP|Subjects in this group will be advised to follow My Dia-RNP and to incorporate diabetes-specific formula (Nutren®Untuk Diabetik)
15878412|NCT03817099|Other|Usual Care|Subjects in the group continue with the usual care
15878413|NCT03817086|Behavioral|Hand coordination and mental practice|"20 chronic (>1year) moderate to severe TBI patients, with upper extremity movement deficits, will be randomly and equally assigned to two groups.
~In the experimental group, participants undergo 5 weeks (3 hrs/week) of physical practice training combined with mental practice (MP group)."
15878414|NCT03817086|Behavioral|Hand coordination and action observation|In the control group 2, participants undergo 5 weeks (3 hrs/week) of physical training (PP group).
15878415|NCT03817073|Device|Iowa Oral Performance Instrument (IOPI)|Using biofeedback to attain repetitions of 80% of baseline MIP.
15878416|NCT03817060|Procedure|cryopreservation of embryos at cleavage stage|cryopreservation of embryos at cleavage stage (day 3) of embryo development
15878417|NCT03817060|Procedure|cryopreservation of embryos at blastocyst stage|cryopreservation of embryos at blastocyst stage (day 5 or 6) of embryo development
15878418|NCT03817047|Behavioral|Physical education|"Physical education (60 minutes): In addition to the ordinary PE-lessons. The pedagogical activities taught in this lesson should be in line with the curriculum of 9th grade and led by the PE-teacher. In the Don't worry - be happy intervention this class was also organized by the students. The students practiced their Be Happy-activities, or they introduced their class peers to their Be Happy-activity. A PE-teacher was present to support the students if necessary."
15878419|NCT03817047|Behavioral|Physical active learning|The curriculum of the subjects (i.e. maths, English, Norwegian) were taught in a physically active manner. The lesson should last 30 minutes and be led by the teacher of the current subject.
15878420|NCT03817047|Behavioral|Physical activity|"Without a connection to any specific subject Physical activity should be performed as 30 minutes a week. There are no specific aims to be taught in this lesson, but physical activities that stimulates mastery, joy and well-being should be in focus."
15878421|NCT03817047|Behavioral|Be happy|The Be Happy classes were self-organized activity groups of at least three students, developed according to activity preferences across regular classes. The Be Happy groups practiced traditional sports and physical activities, lifestyle sports, dancing, out-door recreation, drama etc. - inside or outside school.
15878422|NCT03817034|Drug|Multimodal analgesia|Subjects will be given a rectus sheath block containing dexmedetomidine, ropivacaine, and ketorolac
15878423|NCT03817021|Behavioral|CORE NAP SACC|Modify the food environment following a self-assessment of current food conditions
15878424|NCT03817021|Behavioral|Early Childhood Education|Provide online training for Head Start educators
15878425|NCT03817021|Behavioral|Parent Responsive Feeding|Visit parents in their homes to educate them on responsive feeding
15878426|NCT03817021|Behavioral|Child regulation|Through classrooms lessons cover 3 topics: 1) self-regulation, 2) hunger and fullness, and 3) mindfulness in eating and attention control practices
15878427|NCT03817008|Procedure|Ascending aorta replacement with graft|Patient with planned Ascending aorta replacement with graft
15878428|NCT03816995|Device|CleanCision Wound Retraction and Protection System|wound retraction and irrigation
15878429|NCT03816995|Device|Alexis O Wound Protector|wound retraction
15878466|NCT03816696|Drug|GSK3640254|GSK3640254 will be available as 100 mg capsules. Subjects will be administered GSK3640254 200 mg QD via the oral route.
15878430|NCT03816982|Procedure|Single-injection bupivacaine HCl plus liposomal bupivacaine|Patients in the liposomal bupivacaine with added bupivacaine HCl ISB group will be given a single injection LB ISB in the preoperative area only by faculty who are part of the regional anesthesia division. The injectate will include liposomal bupivacaine 10ml (133mg) mixed with bupivacaine HCl 0.5% 10 ml.
15878431|NCT03816982|Procedure|Single-injection bupivacaine HCl plus a subsequent bupivacaine CISB|Patients in the bupivacaine CISB group will undergo catheter placement with ultrasound guidance only by faculty who are part of the regional anesthesia division. A 20 mL single bolus ISB with 0.25% bupivacaine will be administered followed by catheter infusion of 0.125% bupivacaine at a rate of 5mL/hour postoperatively by the ON-Q pump
15878432|NCT03816969|Device|Self-pressurized air-Q with blocker|"It has a drain tube through which a suction tube is passed like the Air-QILA blocker, and Instead of the pilot balloon and inflating cuff, the air-Q SP with blocker incorporates a self-regulating periglottic cuff at the end of this tube , a communication orifice at the junction of the peri-glottic cuff and the airway tube.
~This communication between two spaces enables the cuff to dynamically regulate intra-cuff pressure depending on airway pressure. This distinguishing feature of the air-Q SP may result in reduced risk for airway morbidities related to cuff hyperinflation"
15878433|NCT03816969|Device|Air-Q ILA blocker|A good seal will provide good ventilation, will guarantee the desired depth of anesthesia at lower gas flows and with lesser leaks to the esophagus, it will not cause rise in intragastric pressure thus preventing regurgitation However, When the cuff pressure is more than the mucosal perfusion pressure, it is likely to either cause postoperative pharyngo-laryngeal symptoms (sore throat, dysphagia, dysphonia) or cause local mucosal trauma and nerve injuries
15878434|NCT03816956|Drug|AR-301|AR-301 (tosatoxumab) 20 mg/kg administered once intravenously the day of enrolment.
15878435|NCT03816956|Other|Placebo|Placebo comparator
15878436|NCT03816943|Behavioral|Whatsapp|a WhatsApp message with encouraging words will be sent after bond up
15878437|NCT03816943|Behavioral|Call|a telephone call will be made after bond up to provide encoring words
15878438|NCT03816930|Procedure|mechanical cord usage|Due to the retraction procedures, same preparation conditions will be obtained.
15878439|NCT03816917|Other|cutaneous parameters of psoriasis (exposure)|characteristic of the cutaneous domains of the psoriasis: age at start, disease duration, current and previous treatment PASI, BSA, nail involvement
15878440|NCT03816917|Other|comorbidity (exposure)|medical and medication history, current and previous comorbidity
15878441|NCT03816917|Other|family history (exposure)|Family history of PsC, PsA, IBD, AS, and uveitis
15878442|NCT03816917|Other|lifestyle (exposure)|"Intoxications
~Lifestyle: occupation and injuries, sport and physical hobbies"
15878443|NCT03816917|Other|patient reported outcomes (exposure)|VAS-score on fatigue, PsC severity, joint pain and general well-being
15878444|NCT03816917|Other|inflammatory markers (exposure)|Measurements of inflammatory and bone remodeling markers in serum and plasma
15878445|NCT03816917|Other|genetic (exposure)|Assessment of known HLA- and SNP-associations with PsA or PsA
15878446|NCT03816904|Other|Blood samples|Blood samples before the introduction of chemotherapy
15878447|NCT03816891|Drug|vixarelimab|solution for injection
15878448|NCT03816891|Drug|Placebo|solution for injection
15878449|NCT03816878|Biological|H5N1 pISV|Administered as an intramuscular (IM) injection
15878450|NCT03816852|Biological|hucMSCs|Human umbilical cord mesenchymal stem cells were transplanted by intravenous infusion
15878451|NCT03816839|Drug|Amcenestrant (SAR439859)|"Pharmaceutical form: Capsules
~Route of administration: Oral"
15878452|NCT03816826|Other|physical therapy|both are physical therapy intervention technique used to treat the soft tissue acute injuries
15878453|NCT03816813|Other|blood and saliva sampling|blood and saliva sampling
15878454|NCT03816800|Dietary Supplement|ImmunoBon|The dietary agent contains vitamin A, Zn, chelated iron and whey proteins.
15878455|NCT03816800|Dietary Supplement|Placebo|the dietary agent does not contain vitamin A, Zn, chelated iron and whey proteins
15878456|NCT03816787|Procedure|Negative pressure therapy|Participants assigned to the treatment group will receive wet-cupping therapy 1 times per week for 4 weeks
15878457|NCT03816774|Drug|PEG split-dose and simethicone|Patients in active comparator arm are instructed to take 250mg simethicone pill 15 minutes before PEG dose on the previous evening plus 250mg simethicone pill 15 minutes before PEG dose ending 3 hours before colonoscopy
15878458|NCT03816761|Drug|Fast-acting insulin aspart|In each cohort, participants will receive fast-acting insulin aspart using the iLet™ in a cross-over manner for 14 days (7days per period). Dose modification will be handled autonomously by the iLet™ based on the CGM sensor readings and the user interaction with the iLet™ e.g. meal announcements.
15878459|NCT03816761|Device|iLet™|The bionic pancreas including pigtail adapters, used in insulin-only configuration
15878460|NCT03816748|Device|High flow nasal cannula, HFNC|The HFNC used in this study can supply more than 40-60 L/min of oxygen flow, which is many times higher than the traditional nasal cannula. In addition, HFNC provides heating and moisturizing functions, so the patients 'nasal and oropharyngeal cavities do not dry out. This way, the patients can wear HFNC continuously for many days. Furthermore, when the patients close their mouths, HFNC can create a PEEP of 6-8 cmH2O, which helps with lung expansion after chest surgeries and lowers the risk of pneumonia related to lung collapses.
15878461|NCT03816735|Device|Cikatridina|Women are asked to insert the suppositories according to the manufacturer's protocol.
15878462|NCT03816735|Device|Juliet Feminine Laser|Women will receive the laser treatment twice during the study period.
15878463|NCT03816722|Device|Airvo2|Treatment with HighFlow through the Airvo2 device, 8 hours per day
15878464|NCT03816722|Other|Usual care|"High flow treatment is investigated as an add on treatment to the personalized care already prescribed to the patients. As patients with interstitial lung disease very often demand very different treatment set ups treatment will vary in the individual patients. All will, however, be treated with ambulatory oxygen. Usual care will be unaltered a month before inclusion in the study in each of the individual patients"
15878465|NCT03816709|Device|Therapeutic Ultrasound|A therapeutic ultrasound treatment was applied to the left medial gastrocnemius muscle with the following parameters: 3 MHz, 1.0 W/cm2 for 15 minutes.
15878590|NCT03815656|Device|STN alone|DBS stimulation of STN alone
15878468|NCT03816670|Drug|Corifollitropin Alfa|late start (day 4) vs. corifollitropin-alfa standard start (day 2)
15878469|NCT03816644|Other|5-Cog|The 5-Cog is a 5 minute cognitive screen which will identify patients with 'cognitive impairment' from those with 'no cognitive impairment'.
15878470|NCT03816644|Other|Health Literacy & Grip Assessment|The health literacy and grip assessment will take approximately 5 minutes, and will test the patient's comprehension and pronunciation of health-related terms as well as strength in their dominant hand. The screen will sort out patients with 'low health literacy' and 'frail (low grip strength)' from those with normal health literacy and normal grip strength.
15878471|NCT03816631|Drug|Pimodivir|Participants will receive single oral dose of Pimodivir 600 mg (2*300 mg tablets) under fasted condition on Day 1.
15878472|NCT03816618|Drug|Medihoney Gel in A Tube|TREATMENT1
15878473|NCT03816618|Drug|Hydrogel|PURLOIN GEL
15878474|NCT03816618|Drug|Fucidin Ointment|FUCIDIN ANTIBIOTIC OINTMENT 10%
15878475|NCT03816592|Procedure|Opioid free anaesthesia|patient anesthtesized with lidocaine, ketamine and dexamethasone
15878476|NCT03816592|Procedure|Opioid anaesthesia|patients anesthetized with sufentanil ketamine and dexamethasone
15878477|NCT03816579|Other|PRO-A|30 g of beef protein will be consumed at each meal
15878478|NCT03816579|Other|PRO-B|30 g of complementary proteins will be consumed at each meal
15878479|NCT03816579|Other|PRO-C|30 g of complementary proteins will be consumed over 24 hours
15878480|NCT03816566|Device|patch|A standalone wearable device (the patch), that can record tracheal sounds with a microphone attached just above the suprasternal notch of the subject. The patch also has a 3-dimensional accelerometer to record body position. Furthermore, the patch records oxygen saturation using an FDA cleared pulse oximeter, Nonin 3150 WristOx2® with Bluetooth Low Energy.
15878481|NCT03816553|Drug|SHR-1210|SHR-1210 will be administered as a 30-minute IV infusion Q2W at a dose of 200mg (3mg/kg for underweight patients).
15878482|NCT03816553|Drug|Apatinib|Apatinib will be administered 250mg orally, once daily until progression.
15878483|NCT03816540|Device|HRV and respiratory coherence biofeedback|Biofeedback treatment to support self-regulatory processes on the physiological level: heart rate variability (HRV) and respiratory coherence.
15878484|NCT03816514|Procedure|SpHb monitoring|Noninvasive, continuous pulse oximetry-based hemoglobin (SpHb) monitoring
15878485|NCT03816514|Procedure|Conventional management|Conventional management without SpHb monitoring
15878486|NCT03816501|Other|music|The preference of the patients will be listened to preoperatively through the headphones
15878487|NCT03816501|Other|no music|the patients will not be listened
15878488|NCT03816488|Drug|Metformin|Metformin (usual dose) administered 2 h before surgery
15878489|NCT03816488|Drug|Salsalate|Salsalate 1.5 g administered 2 h before surgery
15878490|NCT03816475|Radiation|Hypofractionated radiotherapy|Preoperative hypofractionated 5x5 Gy radiotherapy (5 consecutive days) prescribed on planned target volume (tumor volume + elective margins + setup/error margin) with daily image guidance.
15878491|NCT03816449|Other|exercises|"Aerobic exercise will be conducted as a dose walk, 3-5 km / h, lasting 50 minutes per day, least five days per week, for 12 weeks. The intensity of the training will be around 70% of the maximal heart rate.
~Resistance training and balance exercises will be conducted as a group program and will involve exercises to strengthen the muscles of the upper and lower extremities and balance exercises. The intensity of the training will be increased on weekly, starting from 3-5 repeating load and its own weight, up to 8-12 repetitions and load straps. Progression and maintenance load tapes will be carried out depending on the capacity of individualized persons. Frequency of training will be 3 times a week,will last 70 minutes per day for 12 weeks."
15878492|NCT03816436|Other|Follow- up (FU) assessment|Follow- up (FU) assessment (clinical examination and patient questionnaires) at least 24 months after surgery (clavicular midshaft and lateral non- union treated by plate and iliac crest bone grafting)
15878493|NCT03816423|Other|video|Participants randomized to the intervention group, will wacth a pre-appointment video, followed by a routine prenatal care visit.
15878494|NCT03816410|Procedure|LAA amputation|complete surgical amputation of the left atrial appendage
15878495|NCT03816397|Biological|Adalimumab|Adalimumab is a fully human monoclonal anti-tumor necrosis factor alpha antibody, a biologic, immunomodulatory drug. Adalimumab 20mg/0.8mL and 40mg/0.8mL is a clear, colorless solution provided in a pre-filled syringe for subcutaneous injection. The formulation is adalimumab, mannitol, polysorbate 80, and water for injection Each pre-filled syringe has a fixed 29-gauge thin wall and ½ inch needle with black protective cover and is intended for a single dose to a single patient.
15878496|NCT03816397|Other|Placebo|The placebo solution is a clear, colorless solution provided in a single-use, pre-filled syringe for subcutaneous injection. The placebo is designed to match the characteristics of the citrate-free adalimumab during injection.
15878497|NCT03816384|Device|Standard of Care|Standard of care urinary drainage system.
15878498|NCT03816384|Device|DLC Group|Urinary drainage system with active drain line clearance and plain silicone catheter.
15878499|NCT03816384|Device|DLCS Group|Urinary drainage system with active drain line clearance and silver-doped silicone catheter.
15878500|NCT03816371|Other|Head-of-bed elevation|Respiratory pattern including respiratory rate, peripheral oxygen saturation and dyspnea, and drainage including amount of drainage and hematoma formation of all patients were evaluated at 1st, 2nd, 3rd, and 4th hours after positions.
15878506|NCT03816332|Biological|Ipilimumab|Given IV
15878507|NCT03816332|Biological|Nivolumab|Given IV
15878508|NCT03816332|Drug|Prednisone|Given PO
15878509|NCT03816332|Drug|Tacrolimus|Given PO
15878511|NCT03816306|Drug|LCZ 696|LCZ696 is an Angiotensin receptor neprilysin inhibitor. It's composed of Sacubitril/Valsartan. LCZ696 starting dose 50 mg P.O. BID, LCZ696 100 mg P.O. BID and up-titration to LCZ696 200 mg P.O. BID.
15878587|NCT03815682|Biological|Arm B: Pembrolizumab|Escalating doses of RPTR-147:1 in combination with Pembrolizumab
15878512|NCT03816293|Device|Negative Pressure Wound Therapy|Occlusive dressing with attached Prevena incision management with 125mmHg of negative pressure and cartridge to manage secretions
15878513|NCT03816280|Procedure|Elective cardiopulmonary bypass (CPB)|All groups undergo elective cardiopulmonary bypass (CPB)
15878514|NCT03816280|Procedure|Alpha-stat acid-base management|Acid-base status during CPB will be maintained using the alpha-stat regime
15878515|NCT03816280|Procedure|pH-stat acid-base management|Acid-base status during CPB will be maintained using the pH-stat regime
15878516|NCT03816267|Device|Nebulizer|Nebulization via mask
15878517|NCT03816267|Drug|Salbutamol|Delivery of appropriate dose according to weight
15878518|NCT03816267|Device|Metered dose inhaler and spacer|Medication will be delivered through inhaler and spacer
15878519|NCT03816241|Other|Frame|Vignette is framed in a way that nudges participant to leave a legacy
15878520|NCT03816241|Other|Norms|Vignette informs the participant that most people choose an option to try to nudge participant into choosing that option as well
15878521|NCT03816228|Drug|F 18 T807 Flortaucipir|Participants will receive a single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807. For those who cannot tolerate the full exam, participants will receive single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807.
15878522|NCT03816215|Behavioral|Volunteer experience|Participants will be assigned to a meaningful volunteer experience from a menu of local options (e.g., volunteering at an animal shelter or in a library) for 30 hours.
15878523|NCT03816202|Device|Sundt carotid shunt|The Integra Sundt™ carotid shunts are indicated for temporary carotid artery bypass during carotid endarterectomy procedures to help protect the cerebral hemispheres from ischemia during the period of carotid artery occlusion.
15878524|NCT03816189|Diagnostic Test|Blood test|Patients in each group will have a blood sample (9x7 mL) for eosinophils isolation, study of activation markers on whole blood and serum biomarkers testing
15878525|NCT03816189|Diagnostic Test|Skin biopsies|In patients who will accept, skin biopsies will be performed in damaged and apparently normal skin, excluding fingers, hands, feet and face (biopsies are facultative)
15878526|NCT03816176|Drug|Isavuconazonium sulfate|Intravenous (IV) infusion
15878527|NCT03816176|Drug|Isavuconazonium sulfate|Oral capsule
15878531|NCT03816137|Biological|ConM SOSIP|Recombinant HIV-1 trimeric gp140 Env protein: ConM SOSIP gp140. Model immunogens will be used at the dosage of 100 ug and will be admixed with 500 ug MPLA formulated in liposomes and administered by intramuscular injection into the left or right deltoid muscle.
15878532|NCT03816137|Biological|EDC ConM SOSIP|Chemically fixed version of recombinant HIV-1 trimeric gp140 Env: EDC-ConM SOSIP. Model immunogens will be used at the dosage of 100 ug and will be admixed with 500 ug MPLA formulated in liposomes and administered by intramuscular injection into the left or right deltoid muscle.
15878533|NCT03816137|Biological|ConS UFO|Recombinant HIV-1 trimeric gp140 Env protein: ConS UFO gp140. Model immunogens will be used at the dosage of 100 ug and will be admixed with 500 ug MPLA formulated in liposomes and administered by intramuscular injection into the left or right deltoid muscle
15878534|NCT03816137|Biological|EDC ConS UFO|Chemically fixed version of recombinant HIV-1 trimeric gp140 Env : EDC-ConS UFO. Model immunogens will be used at the dosage of 100 ug and will be admixed with 500 ug MPLA formulated in liposomes and administered by intramuscular injection into the left or right deltoid muscle.
15878535|NCT03816137|Biological|Mosaic SOSIPs|"Mosaic gp140 Env trimers designed to overcome the immunodominance of hypervariable regions of Env
~The immunogen will be used at the dosage of 100 ug (3x33ug) and will be admixed with 500 ug MPLA formulated in liposomes and administered by intramuscular injection into the left or right deltoid muscle."
15878536|NCT03816124|Procedure|radiofrequency ablation|radiofrequency ablation of the genicular nerves
15878537|NCT03816111|Behavioral|TEACH-PD Training Curriculum|The TEACH-PD training modules have been developed by a core group of renal nurses from the HOME Network in conjunction with senior medical clinicians from the Australasian Kidney Trials Network, eLearning curriculum developers, consumer representatives, and education experts, in line with the International Society for Peritoneal Dialysis guidelines, utilizing modern adult learning principles and best practice eLearning techniques.
15878538|NCT03816111|Behavioral|Current standard PD training|Current PD training materials and plan
15878539|NCT03816085|Other|Shoes|Shoes with different heel heights
15878540|NCT03816072|Drug|Phenylephrine infusion|Correction of anesthesia induced hypotension with phenylephrine to obtain sCA and dCA measurements at 60, 70, 80, 90 and 100 mmHg mean blood pressure. This is achieved by stepwise increases in phenylephrine infusion dose.
15878541|NCT03816072|Other|Mechanical ventilation|Patientes are mechanically ventilated at 6 bpm to obtain low frequency blood pressure oscillations (~0.1 Hz).
15878542|NCT03816072|Drug|Propofol|Propofol
15878543|NCT03816072|Drug|Sevoflurane|Sevoflurane
15878544|NCT03816059|Diagnostic Test|Respiratory virus testing|All patients will be tested for respiratory viruses
15878545|NCT03816046|Drug|botulinum toxin A|injection in hair bearing area of armpits
15878546|NCT03816033|Procedure|Cryotherapy|Catheter ablation treatment for the treatment of the studied arrhythmias
15878547|NCT03816033|Procedure|radiofrequency catheter ablation|Catheter ablation treatment for the treatment of the studied arrhythmias
15878548|NCT03816020|Dietary Supplement|Nicotinamide Riboside|Nicotinamide Riboside capsules 250mg x 2 BID
15878549|NCT03816020|Other|Placebo|Placebo capsules BID
15878550|NCT03816007|Behavioral|Yoga and Mantram Repetition|An existing yoga intervention designed for persons with chronic pain will be augmented with training in mantram repetition. The intervention meets 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
15878551|NCT03816007|Behavioral|Veteran Calm|A relaxation intervention used previously as a comparator intervention will be delivered by a health educator 1x weekly for 75 minutes for 12 weeks, and includes a home practice component.
15878588|NCT03815682|Biological|Arm C: RPTR-147:2|Escalating doses of RPTR-147:2 in patients with HPV positive tumors
15878591|NCT03815656|Device|GPi alone|DBS stimulation of GPi alone
15878552|NCT03815994|Device|Neuromuscular Electrical Stimulation|This device produces a muscle contraction in response to a externally generated low-voltage electric impulse, which is conducted through electrodes placed on the skin over the muscle group to be stimulated.
15878553|NCT03815968|Other|low sodium diet|included in the diet mostly low sodium food. avoid tinned or smoked, food. avoid adding salt to the food.
15878554|NCT03815955|Behavioral|Non-Sedentary Behaviour Modelling|Consistent with social learning theory, the primary care provider and the DIGMA support team will model, demonstrate, and verbalize aspects of increased confidence to perform the 1-hour appointment in a standing position and offer a variety of strategies to cope and overcome any feelings of discomfort. Emphasis will be placed on the strategies the primary care team uses to break sitting with standing and light, incidental movements. It will be anticipated that the participant will observe cues and relevant information specific to their behaviour change and engage in minimal sedentary behaviour.
15878555|NCT03815942|Biological|ChAdOx1-MVA 5T4 vaccine|ChAdOx1.5T4 will be administered intramuscularly in an extremity (e.g. thigh) at a dose of 2.5 x10^10 virus particles followed by MVA.5T4 administered via the same route at the dose of 2x10^8 plaque forming units
15878556|NCT03815942|Drug|Nivolumab Infusion [Opdivo]|Nivolumab is to be administered as a flat dose of 480 mg over approximately 60-minutes via IV infusion
15878557|NCT03815929|Drug|Estradiol 100 Micrograms Patch|Standard
15878558|NCT03815929|Drug|Estradiol Patch|Individualized
15878559|NCT03815916|Drug|Gold Nanocrystals|CNM-Au8 is a dark red/purple-colored liquid formulation consisting of a stable suspension of faceted clean surfaced elemental gold nanocrystals in buffered deionized water with a concentration of up to 0.5 mg/mL of gold. The formulation is buffered by sodium bicarbonate present at a concentration of 0.546 mg/mL. There are no other excipients. The drug product is formulated to be taken orally and will be provided in single dose HDPE containers. The study doses vary by the concentration of gold nanocrystals per milliliter in a volume of 60 mL.
15878560|NCT03815903|Drug|Induction chemotherapy|3 cycles, each 21 days, of Cisplatin 80mg/m2 plus Paclitaxel 175mg/m2
15878561|NCT03815903|Combination Product|Chemoradiotherapy|Radiotherapy 70Gy convencional fractionation concomitant to 3 cycles, each 21 days, of Cisplatin 100mg/m2
15878562|NCT03815890|Drug|Nivolumab|2 courses 240 mg flat dose
15878563|NCT03815890|Drug|Ipilimumab|single dose ipilimumab (1mg/kg) at day 1
15878564|NCT03815890|Drug|Ipilimumab|two courses ipilimumab (1mg/kg) at day 1 and 21
15878565|NCT03815877|Dietary Supplement|Nescafe Gold ® coffee|"Nescafe Gold ® coffee (5gm per 100cc water containing 170 mg of caffeine) will be used for all the women in the intervention group.
~- patients will drink 100cc coffee with 1 tea spoon added sugar at 3, 6 and 9 hours after the surgery."
15878566|NCT03815877|Dietary Supplement|Nescafe Gold DECAF® coffee|"Nescafe Gold DECAF coffee (5 gm per 100cc water containing 5-10 mg of caffeine) will be used for all the women in the control group.
~the control group will drink 100cc decaffeinated coffee with 1 tea spoon added sugar at 3, 6 and 9 hours after the surgery."
15878567|NCT03815864|Diagnostic Test|Luminex-based solid phase assay of banked sera for anti-HLA antibodies directed against the donor of a second liver transplantation|Anti-AT1R antibodies were tested on pre-transplantation sera using ELISA kit (Lot #30, One Lambda, Canoga Park, CA)
15878568|NCT03815851|Device|prophylactic drainage|leave prophylactic drainage after surgery
15878569|NCT03815838|Diagnostic Test|PET imaging|Positron emission tomography imaging using 18F-Fallypride and 18F-FDOPA
15878572|NCT03815812|Drug|IBI306|Cohort 1: 75mg Q2W Cohort 2: 140mg Q2W Cohort 3: 300mg Q4W Cohort 4: 420mg Q4W Cohort 5: 450mg Q6W Cohort 6: 600mg Q6W
15878573|NCT03815812|Drug|placebo|Cohort 1: 75mg Q2W Cohort 2: 140mg Q2W Cohort 3: 300mg Q4W Cohort 4: 420mg Q4W Cohort 5: 450mg Q6W Cohort 6: 600mg Q6W
15878574|NCT03815799|Procedure|Bilateral Erector Spinae Block|A linear ultrasound transducer will be place in a longitudinal parasagittal orientation about 3 cm lateral to spinous process. 40 ml bupivacaine/lidocaine mixture will be injected into the fascial plane on the deep aspect of erector spinae muscle. Standard perioperative and postoperative analgesia protocol will be given and postoperative pain levels will be determined by Numerical rating scale (NRS).
15878575|NCT03815799|Other|Control|Standard perioperative and postoperative analgesia protocol will be given consisting of paracetamol 1 gr IV and tenoxicam 20 mg IV initiated after induction of anesthesia. At the end of the operation patients will receive meperidine 0.5 mg/kg IV before extubation. Postoperative pain levels will be determined by Numeric Rating Scale (NRS) system, 20 minutes intervals in the first hour and at 2th, 6th, 12th and 24 th hour. For the first hour in the postoperative care unit, tramadol 50 mg IV will be given for rescue analgesia with minimum 20 minutes between doses, in patients showing a NRS ≥ 4. Paracetamol 1 g / 12 hour will be given during ward follow-up. In the ward in patients showing a NRS ≥ 4 tramadol 50 mg IV will be given for analgesia.
15878576|NCT03815786|Dietary Supplement|Symbiotic|2-months oral administration of the symbiotic supplement (2 bags/day) + 1 month washout
15878577|NCT03815786|Dietary Supplement|Placebo|2-months oral administration of the placebo (2 bags/day) + 1 month washout
15878578|NCT03815760|Device|Blood Flow Restriction|Subjects will perform sidelying external rotation exercise
15878579|NCT03815747|Device|High-Intensity Focused Electromagnetic (HIFEM) Field Device|The High-Intensity Focused Electromagnetic (HIFEM) Field device will be applied.
15878580|NCT03815734|Procedure|motor imagery|motor imagery during the postoperative immobilization period
15878581|NCT03815721|Device|Stimulette r2x+|device for repetitive transcutaneous spinal cord stimulation
15878586|NCT03815682|Biological|Arm A: RPTR-147:1|Escalating doses of RPTR-147:1 as a monotherapy
15878592|NCT03815656|Device|STN + GPi|cooperative DBS stimulation of STN and GPi sites
15878593|NCT03815656|Device|Closed-loop stimulation|adaptive DBS stimulation of STN and/or GPi sites
15878594|NCT03815643|Drug|Avelumab|Participants entering this roll over study will receive avelumab as a 1-hour intravenous (IV) infusion at 10 milligram per kilogram (mg/kg) once every 2 weeks until progressive disease, according to respective parent studies (EMR100070-001, EMR100070-002, EMR100070-004 and EMR100070-008).
15878595|NCT03815630|Drug|pd-1 and dc-cik cells|Total dose of 10ml Keytruda will be administered at day0, 60million DC cells and 1.5 billion CIK at day1, 1.5 billion CIK cells at day2, 1.5 billion CIK cells at day3 .
15878596|NCT03815617|Dietary Supplement|Zircombi|Twenty-five IBS patients (Rome IV criteria) (M:F= 8:17; age 48 yrs ± 11 SD) were enrolled and randomized to treatment or placebo in a a crossover randomized double-blind two-block placebo-controlled trial. Abdominal pain and bloating, intestinal habits, severity of disease, intestinal permeability, and intestinal microbiota were performed at the different time points.
15878597|NCT03815617|Dietary Supplement|Placebo|Given as comparable packets. Same duration.
15878598|NCT03815604|Behavioral|Independent Housing and Support (IHS)|Direct placement of people with SMI in an independent accommodation in the community, usually in a flat rented by the service user. Support is provided by a coach according to individual needs in a permanent housing situation without time limit.
15878599|NCT03815604|Behavioral|Residential Care Settings and other Treatment as Usual (RCS/TAU)|Placement in a common residential home or supportive housing setting with the aim to gain psycho-social stability before being able to maintain independent housing.
15878600|NCT03815591|Device|smokeSCREEN web-based game|smokeSCREEN tobacco use reduction/prevention web-based game. The game has 1.5-2 hours of unique game play and focuses on combustible cigarettes, e-cigarettes, and flavored tobacco products. Guided by the social cognitive theory and the theory of planned behavior, smokeSCREEN addresses a range of challenges that teens often face involving peer pressure and the use of tobacco products. Participants are provided access to the smokeSCREEN game through a private, password-protected website link and instructed to complete the game.
15878601|NCT03815578|Other|Clinical examination|"Number of painful joints,
~Number of swollen joints,
~Patient Global assessment VAS (0 - 100)
~and Physician Global assessment VAS (0 - 100)"
15878602|NCT03815578|Other|Pain assessment|"Pressure Pain Thresholds (PPTs),
~Mechanical Temporal Summation (MTS)
~and Diffuse Noxious Inhibitory Control (DNIC)"
15878603|NCT03815578|Other|blood sample|18 ml whole blood for ELISA analysis and miRNAs detection
15878604|NCT03815578|Other|Patient Reported Outcomes|"Health Assessment Questionnaire (HAQ),
~Rheumatoid Arthritis Impact of Disease score (RAID),
~Daily joint pain intensity VAS (0-100),
~Hospital Anxiety and Depression scale
~and Coping Strategy Questionnaire."
15878605|NCT03815565|Procedure|continuous femoral block|infusion of anesthetic by PCA pump
15878606|NCT03815552|Device|Eversense Continuous Glucose Monitoring|The Eversense Continuous Glucose Monitoring System is a glucose monitoring device intended to continually measure interstitial fluid glucose levels in individuals with diabetes for the operating life of the sensor.The System comprises a sensor and a transmitter. The small sensor will be subcutaneously inserted in the arm.The transmitter reads glucose data from the subcutaneous sensor.
15878607|NCT03815539|Device|0.1% sodium hyaluronate|In dry eye group, part of the subjects will be instilled with one drop of 0.1% sodium hyaluronate in one of their eyes, then they will be tested with the devices of Oculus Keratograph 5M and Optical Quality Analysis SystemⅡ at different time points (10min, 30min, 60min, 90min and 120min).
15878608|NCT03815526|Other|Dynamic tape|Dynamic tape apply 1 time
15878609|NCT03815526|Other|Kinesio tape|Dynamic tape apply 1 time
15878610|NCT03815526|Other|Sport tape|Dynamic tape apply 1 time
15878611|NCT03815513|Other|brain MRI|both case and control groups received brain MRI to evaluate cerebrovascular reactivity
15878612|NCT03815500|Behavioral|Enhanced Education|Enhanced educational curriculum will involve learning modalities including 3D modeling, video, and visual-aid enhanced text for references to improve caregiver and patient understanding of wound packing techniques.
15878613|NCT03815487|Device|Medtronic MiniMed 670G Insulin Pump in Auto Mode|This kind of intervention will be part of the intensified insulin therapy for type 1 diabetic patients. The system will help to keep blood glucose in a defined range by automatic assisted adaption of insulin dosing.the HCL provides a lot more automatic functions to keep glucose in target compared to SAP.
15878614|NCT03815487|Device|Medtronic MiniMed 670G Insulin Pump without Auto Mode|Sensor augmented pump therapy means the addition of alerts according to high or low glucose values as well as trend arrows showing actual glucose trends to pump therapy. There is no automatic adaption of insulin dosing. The patients must respond manually after alarm or according to the trend arrows.
15878615|NCT03815474|Drug|anlotinib|Anlotinib 12 mg once daily for 14 days tablet by mouth ; epirubicin 30mg/m2 intravenous injection from 1 day to 2 , ifosfamide 1.8g/m2 intravenous injection from 1day to 5day with 6 cycles. Anlotinib 12 mg once daily for 14 days tablet by mouth to progressive disease
15878616|NCT03815461|Drug|Nab-paclitaxel and S-1|Nab-paclitaxel was administered at 125mg/m2 intravenously on day 1 and 8, S-1 （80, 100, or 120 mg/d according to body-surface area on days 1 through 14 of a 21-day cycle for 4-6 cycles.
15878617|NCT03815448|Drug|Methotrexate|Participants randomized to methotrexate group will receive active drug, methotrexate. Starting from 5 mg/week, the dosage will be adjusted to 10 mg/week if the participants can tolerate for 2 weeks. After 2 weeks, the dosage will be adjusted to 15 mg/week until the end of the study if the participants can tolerate.
15878618|NCT03815448|Other|Placebo|Participants randomized to placebo group will receive placebo tablets. Starting from 5 mg/week for 2 weeks, the dosage will be adjusted to 10 mg/week; after 2 weeks, the dosage will be adjusted to 15 mg/week until the end of the study.
15878619|NCT03815435|Procedure|Total intravenous anaesthesia|Induction of anaesthesia: Sufentanil ( 0.2ug/kg) + Propofol (2 -3 mg /kg) + Rocuronium (0.6 mg/kg) Management of anaesthesia: continuous administration of Propofol 6-12 mg /kg/h + Sufentanil boluses of 10 ug as needed. The target BIS value: 40-60 Hypotensives: Nitro Pohl 1mg/ml 0-10 ml/h
15878620|NCT03815435|Procedure|Balanced anaesthesia group|Induction of anaesthesia: Sufentanil ( 0.2ug/ kg) + Propofol (2-3 mg /kg) + Rocuronium (0.6 mg/kg) Management of anaesthesia: Desflurane 0.8-1.2 MAC + Sufentanil boluses of 10 ug as needed. The target BIS value: 40-60
15878621|NCT03815422|Procedure|Regional anesthesia|Short lasting sciatic nerve block and long lasting plantar block with distal deep peroneal block
15878622|NCT03815409|Other|Treadmill with partial weight unload|10-minute treadmill walk with a support corresponding to 20% of his/her own weight, followed by a 5-minute rest and a second 10-minute session on the treadmill with a support corresponding to 10% of his/her own weight. In the initial treadmill session, the starting speed of the treadmill was set to 0.5 km/h, subsequent increments of 0.5 km/h per minute were added to reach the maximum speed that was comfortably tolerated by the patient. This latter was used for the entire training period.
15878623|NCT03815409|Other|Traditional PT rehabilitation treatment|Every 40-minute treatment session consisted in isotonic and isometric exercises for the major muscles of the limbs and trunk including cardiovascular warm-up exercises (5 minutes), muscle stretching exercises (10 minutes), muscle stretching exercises for functional purposes (10 minutes), balance training exercises (10 minutes), relaxation exercises (5 minutes)
15878624|NCT03815396|Drug|INBRX-101/rhAAT-Fc|INBRX-101 is a recombinant human alpha-1 antitrypsin (AAT) Fc fusion protein (rhAAT-Fc).
15878625|NCT03815383|Biological|C-CAR088|Autologous BCMA-directed CAR-T cells by a single infusion intravenously will be given in escalating doses.
15878626|NCT03815370|Device|Experimental: ABRO™ Binder Arm|ABRO™ is an abdominal device designed to be positioned superficially on the abdominal skin of patients managed with the Open Abdomen strategy. The device is comprised of two rigid plates to stabilize the abdominal muscles thus preventing buckling of these. Another element of this novel device is the circumferential dynamic retainer (CDR). This one is passed behind the patient's back to provide more stability to the muscles in the abdomen keeping them in position to prevent lateral movement of them.
15878627|NCT03815370|Device|Placebo Comparator: Usual Care|"The current approach for temporary coverage of abdomen is called vacuum assisted techniques (VAT). This technique requires the use of vacuum-assisted drainage to remove blood or watery fluid from a wound or operative site."
15878628|NCT03815357|Other|Referral to Immunology|Screening for primary immunodeficiency and splenic dysfunction
15878629|NCT03815344|Drug|Standard|20 units diluted in 100mL of Normal Saline injected laparoscopic needle
15878630|NCT03815344|Drug|Standard-vaginal misoprostol|20 units diluted in 100mL of Normal Saline injected laparoscopic needle and misoprostol 400 mcg
15878631|NCT03815331|Drug|Xiaflex®|medication indicated for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy. Xiaflex belongs to a family of enzymes called collagenases. Collagenases are proteinases that hydrolyze collagen in its native triple helical conformation under physiological conditions, resulting in lysis of collagen deposits. The signs and symptoms of Peyronie's disease are caused by a collagen plaque. Injection of XIAFLEX into a Peyronie's plaque, which is comprised mostly of collagen, may result in enzymatic disruption of the plaque. Following this disruption of the plaque, penile curvature deformity and patient bother caused by Peyronie's disease are reduced
15878632|NCT03815331|Drug|Aveed|Aveed® is an FDA-approved medication for treatment of hypogonadism (low testosterone). It is not approved for the treatment of Peyronie's Disease. Aveed® 750 mg/3mL injection will be placed intramuscularly at the beginning of study, at four weeks, at 10 weeks thereafter.
15878633|NCT03815318|Drug|Recombinant Human Coagulation FVIII|Participant received SCT800 for prophylaxis with 25 - 50 IU/kg injection once every other day or three times per week for 6 months.
15878634|NCT03815305|Drug|Centella Asiatica Extract|centlla asiatica oral drug at 1100 mg dose
15878635|NCT03815305|Drug|Topical CA|1% centella asiatica ointment
15878636|NCT03815305|Drug|Petroleum jelly|vaseline album
15878637|NCT03815292|Drug|MMH-MAP|Oral administration
15878638|NCT03815292|Drug|Placebo|Oral administration
15878639|NCT03815279|Drug|Carfilzomib|Carfilzomib will be administered intravenously three times per cycle (28 day cycles) for cycle 1-12. Thereafter twice per cycle for cycle 13-24
15878640|NCT03815279|Drug|Lenalidomide|Lenalidomide PO once daily on days 1-21 of a 28 day cycle
15878641|NCT03815279|Drug|Dexamethasone|Dexamethasone will be administered weekly
15878642|NCT03815266|Diagnostic Test|transcranial Direct Current Stimulation (tDCS)|"transcranial Direct Current Stimulation (tDCS) is device which consist in setting up an electrode on the skull of the patient to deliver the low intensity current.
~Patient will have transcranial Direct Current Stimulation (tDCS) at each session and at the same time of Computerized Mirror Therapy (CMT)."
15878643|NCT03815266|Diagnostic Test|Computerized Mirror Therapy (CMT)|Computerized Mirror Therapy (CMT) will be realizing by the device Intensive Visual Simulation 3 (IVS3). Patient will have Computerized Mirror Therapy (CMT) at each session and at the same time of transcranial Direct Current Stimulation (tDCS).
15878644|NCT03815266|Diagnostic Test|Tolerance Assessment Questionnaire|The Tolerance Assessment Questionnaire will be completed at the end of each session.
15878645|NCT03815266|Diagnostic Test|Ashworth's scale|Ashworth's scale evaluates the resistance to stretching. This test will be completed before the start of the program, at the end of the program and one month after.
15878646|NCT03815266|Diagnostic Test|Frenchay arm test|"Frenchay arm test evaluates your abilities with the affected hand to perform several actions.
~This test will be completed before the start of the program, at the end of the program and one month after."
15878647|NCT03815266|Diagnostic Test|Abilhand questionnaire|"Abilhand questionnaire evaluates your abilities to perform several activities in the daily life with your arm affected.
~This test will be completed before the start of the program, at the end of the program and one month after."
15878648|NCT03815266|Diagnostic Test|Fugl-Meyer test|"Fugl-Meyer test evaluates your ability to perform different movements with all the joints of your arm affected.
~This test will be completed before the start of the program, at the end of the program and one month after."
15878649|NCT03815266|Diagnostic Test|Goal Attainment Scaling (GAS)|"Goal Attainment Scaling (GAS) sets therapeutic goals with the patient before the start of the program.
~These goals will be checked at the end of the program and one month after."
15878650|NCT03815253|Other|acupuncture|"Body electro-acupuncture will choose eight acupoints as Tianshu(ST-25), Daheng(SP-15), Daimai(GB-26), Qihai(CV-6), Zhongwan(CV-12), Zusanli (ST-36), Fenlong(ST-40), Sanyinjiao(SP-6).Disposable acupuncture needles (verum acupuncture needles asia-med Special No. 16 with 0.30 x 0.30mm matching the Streitberger sham-needles) will be inserted at a depth of 10-25 mm into the points.
~We will also deliver electrical stimulation with dense-disperse waves with 50Hz at 10 volts through electrical acupuncture stimulation instrument (ES-160 6-Channel Programmable Electro-acupuncture) to the abdominal points. The bodily needles will be retained for 30 minutes."
15878655|NCT03815227|Other|Outpatient birth|Maternity out the same date or the next day of the birth and home-based follow up with a liberal midwife
15878656|NCT03815214|Behavioral|Partial meal replacement program|Four meals consist of meal replacements made by OPTAVIA, such as shakes, soups, bars, biscuits, hot drinks, and puddings. Meal replacements will be provided to subjects without charge. For two other daily meals, subjects or their caregivers will be taught how to prepare meals consisting of 5-7 ounces (cooked) of a low-fat protein, 3 servings of non-starchy vegetables, and up to 2 servings of healthy fats.
15878657|NCT03815214|Behavioral|Dietary Counseling|Participants will receive one 45-minute counseling session on a healthy diet
15878658|NCT03815201|Dietary Supplement|Group 2|leucine-enriched protein supplementation during the first 1/2 hour post-training
15878659|NCT03815201|Other|Group 1|placebo, an energy-matched mixture, during the first 1/2 hour post-training
15878660|NCT03815175|Device|XIENCE|Subjects who received XIENCE family stent systems will be included.
15878661|NCT03815175|Drug|DAPT (aspirin and/or P2Y12 receptor inhibitor)|"1-month clear subjects (pooled from Xience 28 USA study and Xience 28 Global study) will receive 1 month of DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days and will discontinue P2Y12 receptor inhibitor as early as 28 days and will continue with aspirin monotherapy through 12-month follow-up."
15878662|NCT03815162|Dietary Supplement|High Flavanol Cocoa extract|Experimental group
15878663|NCT03815162|Dietary Supplement|Alkalised cocoa|Control group
15878664|NCT03815149|Device|Pipeline™ Flex Embolization Device with Shield Technology™|Neurointerventional procedures to treat intracranial (cerebral) aneurysms are minimally-invasive procedures performed by Interventional Neuroradiologists. The physician accesses the arterial system through a blood vessel in the groin followed by the insertion of a catheter. Pipeline™ Flex Embolization Device(s) with Shield Technology™,a flow diversion device, is implanted under high-magnification subtraction fluoroscopy, requiring the use of ancillary devices, such as micro-catheters and guidewires to complete the procedure under general anaesthetic. Procedural heparinisation and preloading with dual antiplatelet therapy (DAPT) using acetyl-salicylic acid and P2Y12 inhibitors such as clopidogrel or prasugrel are required.
15878665|NCT03815136|Other|Chewing Gum|Patients of CG group chewed one piece of sugarless gum for approximately 15 min every 30 min at the first hour of the examination.
15878666|NCT03815136|Other|Control|The control group will not chew chewing gum while undergoing capsule endoscopy
15878667|NCT03815123|Diagnostic Test|cardiac CT|The cardiac CT examinations are indicated by the referring physician. The participation in this study has no influence on the further diagnostic and therapeutic regimen.
15878668|NCT03815097|Procedure|Mapleson circuit and nasal trumpet|The Mapleson Circuit is a breathing system used to deliver oxygen and remove carbon dioxide during anesthesia. It consists of fresh oxygen flow, a reservoir bag, an expiratory valve, tubing, and a connection to the patient. There are different types of Mapleson circuits depending on the different arrangements of its components. We plan to use a Mapleson D circuit attached to a nasal trumpet via a connector.
15878669|NCT03815084|Drug|pd-1 and DC-NK cells|total dose of 10ml KEYTRUDA® (pembrolizumab) will be administered at day0, 60million DC cells and 3 billion NK at day1, 3 billion NK cells at day2, 3 billion NK cells at day3 .
15878670|NCT03815071|Drug|Ips-nsc cells|Total dose of ips-nsc cells will be administered at day0.
15878671|NCT03815058|Biological|RO7198457|Participants will receive a recommended dose of RO7198457 administered by IV infusion at protocol-defined intervals.
15878672|NCT03815058|Drug|Pembrolizumab|Participants will receive 200 mg pembrolizumab administered by IV infusion Q3W.
15878673|NCT03815045|Procedure|Landmark-based lumbar puncture|Traditional landmark based lumbar puncture involves palpating spinous processes on the back and finding the inter-spinous space which is the site of needle entry to gain access to the thecal sac. Finding this space may be difficult by palpation, especially when subjects undergoing the procedure are obese, elderly, have had prior back surgery, or if the patient is positioned incorrectly.
15878674|NCT03815045|Procedure|Ultrasound-guided lumbar puncture|Ultrasound guided lumbar puncture is a novel technique being increasingly utilized by emergency physicians, pediatricians and anesthesiologists. In this technique, an ultrasound probe is used to visualize the inter-spinous space. This space can be marked on the skin as the potential point of entry. This could potentially make it easier when patient factors make it difficult to palpate and find the site of entry.
15878675|NCT03815032|Device|Drift assessment of OptoWire Deux FFR wire (1)|Simultaneous data of two different OptoWire DeuxTM guidewires (group 1) to assess a single coronary stenosis and detect any difference if any.
15878676|NCT03815032|Device|Drift assessment of OptoWire Deux FFR wire (2)|Simultaneous data of one Optowire Deux TM guide wires and one VERRATA-TM FFR wire (group 2) to assess a single coronary stenosis and detect any difference if any.
15878677|NCT03815019|Drug|Megestrol Acetate|The proposed study will use megestrol 6 mg/kg/day in two doses because this dose has been effective and safe in two previous studies using megestrol to stimulate appetite in children transitioning from tube to oral feedings. The megestrol will be dosed at full dose weeks 10-11, at 66% dose week 12, at 33% dose week 14, and fully tapered at the end of week 14. Megestrol is absorbed from the small bowel, so feeding it through the tube will be acceptable.
15878678|NCT03815019|Behavioral|iKanEat Behavioral Intervention|"The 24 week iKanEat intervention is composed of 4 clinic visits and a series of 12 tele-visits. All visits (clinic and tele-visits) will focus directly on the oral-motor and behavioral skills necessary for oral eating.
~Tele-visits will begin by building rapport and asking for a summary of all relevant information since the last point of contact, including parent perception of changes in weight, feeding habits, progress, stress of parent/child, and illness. The majority of the time left in the 30 minute session will be spent dealing with parent concerns, which our previous project indicates may include questions about measures, questions about implementation of the iKanEat protocol, and ensuring that children/families adhere to the oral-motor and behavioral guidelines for feeding."
15878679|NCT03815006|Device|Free Style Libre|FreeStyle Libre (FSL) is a novel glucose monitoring device (Flash glucose monitoring) in the form of a disc worn on the arm for 14 days and a hand-held reader which is designed to largely replace the recommended 4-10 painful finger-stick blood glucose tests required each day for the self-management of type 1 diabetes (T1D).
15878680|NCT03814980|Behavioral|mindful breathing application|Participants will use a mindful breathing application on a computer tablet.
15878681|NCT03814980|Device|application on a computer tablet|a computer tablet
15878682|NCT03814967|Device|Transcranial Direct Current Stimulation|In tDCS, saline-soaked electrodes are temporary affixed to the scalp and connected to a battery-powered current generator. A weak (2 mA) constant current is then briefly applied (~20 minutes) to stimulate the targeted brain area (e.g. the DLPFC). To control for placebo effects, the study will utilize a sham stimulation protocol that consists of very brief constant stimulation (~1 minute). Subjects usually cannot discern the difference between the sham and experimental stimulation protocols due to habituation.
15878683|NCT03814954|Drug|Salbutamol|At first day of admission, patients will receive 3 doses of nebulized salbutamol every 20 minutes. Then after 24 hours patients will receive standing dose according to clinical status
15878684|NCT03814954|Drug|Epinephrine|At first day of admission, patients will receive 3 doses of nebulized epinephrine every 20 minutes. Then after 24 hours patients will receive standing dose according to clinical status
15878685|NCT03814941|Other|paper-based anesthesia record|to evaluate the incidence of artifacts in the AIMS database by paper-based anesthesia record
15878686|NCT03814941|Other|electronic documents|to evaluate the incidence of artifacts in the AIMS database by electronic documents anesthesia record
15878687|NCT03814928|Behavioral|Caregivers e-Learning Course|Investigators will request that family/caregivers watch a self-paced (60-90 minutes) online e-learning training session for recovery after hip fracture.
15878688|NCT03814902|Device|Electronic Tracking Device|This commercially-available electronic tracking device uses Global Positioning System (GPS) technology to display the wearer's location on a mobile phone, tablet, or computer. The device may be securely attached to clothing and is designed to be worn by children with developmental disabilities. Parents may use the associated application to view the child's location when the device is turned on and active.
15878689|NCT03814889|Device|Vibration pattern|"PHASE 1 and PHASE 2 are pilot studies not included in the clinical trial.
~Phase 2b: All participants try on several wearable prototypes in our laboratory that provide vibration to the arm. Sensors or electrodes taped onto the arm and hand will sense muscle activity and record any changes during periods of vibration and periods with vibration turned off.
~PHASE 3: Patients will be given a wearable device to take home. The patient will wear the device daily. At the beginning and end of the phase, arm function will be tested.
~PHASE 4: This study takes 3 or 6 months. 1) If the patient gets Botox injections in their hand and arm, their arm function will be measured for three months during this standard care. 2) Next, all patients will be given a wearable device to take home. The patient will wear the device while feeling vibrations for 3 hours during the day while awake for two months. During this time and 1 month after this intervention, arm function will be tested."
15878690|NCT03814889|Device|No vibration|These patients will wear a glove with a blinking light instead of feeling vibrations.
15878691|NCT03814876|Behavioral|Group session psycho-education|Active comparator - control group
15878692|NCT03814876|Behavioral|FITS|Manualized family intervention
15878693|NCT03814850|Device|Standard Manual Aneroid Sphygmomanometer|Use of a standard manual blood pressure cuff and manometer for the conditioning intervention.
15878694|NCT03814824|Diagnostic Test|IRIS (Intelligent real-time image segmentation)|IRIS has the ability to identify and display three specific images features that may correlate with dysplasia that are represented in different color schemes.
15878695|NCT03814824|Diagnostic Test|VLE (Volumetric laser endomicroscopy)|VLE uses infrared light to produce real time high-resolution cross sectional imaging of the esophagus.
15878696|NCT03814811|Diagnostic Test|Circulating Osteocalcin-positive (cOC) cells|Quantitative measurement of osteocalcin-positive cells in the peripheral blood mononuclear cells by flow cytometry
15878697|NCT03814798|Biological|IGSC 20% daily push versus every 2 weeks pump|IGSC 20% syringe daily push dosing for 16 weeks followed by every 2 weeks pump dosing for 16 weeks or the reverse sequence
15878698|NCT03814798|Biological|IGSC 20% daily push versus once a week pump|IGSC 20% syringe daily push dosing for 16 weeks followed by once weekly ambulatory pump administration dosing for 16 weeks or the reverse sequence
15878699|NCT03814798|Biological|IGSC 20% daily push versus 2 times per week pump|IGSC 20% syringe daily push dosing for 16 weeks followed by 2 times/week ambulatory pump administration on preselected days (eg, Monday and Thursday) not less than 3 days apart for 16 weeks or the reverse sequence
15878700|NCT03814798|Biological|IGSC 20% 150 mg/kg|loading dose of IGSC 20% consisting of 5 consecutive daily doses of 150 mg/kg/day (Week 0, Days 1-5) followed by weekly infusions of IGSC 20% 150 mg/kg starting Week 1 (Day 8) through Week 32 using an infusion SC pump
15878701|NCT03814772|Procedure|Liver transplant|blood transfusion
15878702|NCT03814759|Drug|TS-1 + cisplatin|S-1 20mg/m2, bid (D1~14, D22~35) Cisplatin 30mg/m2/day (W1, 2, 4, 5)
15878703|NCT03814759|Radiation|radiation|radiation 45Gy per 5 weeks
15878704|NCT03814746|Drug|Crizanlizumab (SEG101)|Crizanlizumab will be supplied in single use 10 mL glass vials at a concentration of 10 mg/mL. One vial contains 100 mg of crizanlizumab. This is a concentrate for solution for infusion IV.
15878705|NCT03814746|Drug|Placebo|Placebo will be supplied in single use 10 mL glass vials at a concentration of 10 mg/mL. One vial contains 100 mg of placebo. This is a concentrate for solution for infusion IV.
15878706|NCT03814733|Drug|Rapastinel|Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.
15878707|NCT03814733|Drug|Alprazolam|Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.
15878708|NCT03814733|Drug|Ketamine|Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.
15878709|NCT03814733|Drug|Rapastinel Matched Placebo|Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.
15878710|NCT03814733|Drug|Alprazolam Matched Placebo|Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.
15878711|NCT03814733|Drug|Ketamine Matched Placebo|Participants will be administered single IV doses of rapastinel, ketamine, rapastinel matched placebo, and ketamine matched placebo, and single oral doses of alprazolam and alprazolam matched placebo in a randomized crossover manner.
15878712|NCT03814720|Biological|VRC-FLUNPF099-00-VP (H1ssF_3928)|The vaccine is composed of the HA stem domain from Influenza A/New Caledonia/20/l999 (HlNl) genetically fused to the ferritin protein from H. pylori. Purified HlssF_3928 displays eight well-formed HA trimers that antigenically resemble the native Hl stem viral spikes.
15878713|NCT03814707|Drug|Topical application of 0.2% hyaluronic acid gel|Topical application of 0.2% hyaluronic acid gel will be placed immediately in palatal donor site after free gingival graft harvesting
15878714|NCT03814707|Biological|Platelet rich fibrin|Placement of Platelet rich fibrin in the palatal donor sie after free gingival graft harvesting and suturing by criss cross sutured then covered by periodontal pack.
15878715|NCT03814694|Dietary Supplement|CRHP Diet|Dietary macronutrient composition of 30 E% from carbohydrate, 30 E% from protein and 40 E% from fat
15878716|NCT03814694|Dietary Supplement|CD Diet|Dietary macronutrient composition of 50 E% from carbohydrate, 17 E% from protein and 33 E% from fat
15878717|NCT03814681|Other|Colorectal Surgery|elective Colorectal Surgery
15878718|NCT03814668|Dietary Supplement|Probiotic|Intake of probiotic
15878719|NCT03814668|Dietary Supplement|Lactase|Intake of lactase
15878720|NCT03814668|Other|Placebo|Intake of placebo
15878721|NCT03814655|Procedure|Full digital workflow|Dental implants will be inserted usig a surgical guide performed after prosthetically driven treatment planning. The workflow will be full digital.
15878722|NCT03814655|Procedure|Partially digital workflow|Dental implants will be inserted usig a surgical guide performed after prosthetically driven treatment planning. The workflow will be partially digital.
15878723|NCT03814642|Drug|Clopidogrel 75 mg|Clopidogrel 75 mg tablet
15878724|NCT03814642|Drug|Tegoprazan 50 mg|Tegoprazan 50 mg tablet
15878725|NCT03814642|Drug|Esomeprazole 20 mg|Esomeprazole 20 mg tablet
15878726|NCT03814629|Drug|Weifuchun|The treatment group（Weifuchun group）was given Weifuchun tablets, 4 tablets each time, 3 times a day, and 1 hour after meals. The control group(vitamin group) was given vitamin tablets (0.2 g), 4 tablets each time, 3 times a day, and 1 hour after a meal.
15878727|NCT03814616|Drug|Pyronaridine tetraphosphate 180mg:artesunate 60mg|ACT
15878728|NCT03814603|Procedure|PET-MR Scan|Participants will undergo PET-MR scans at baseline and two-year follow up to examine brain amyloid deposition longitudinally.
15878729|NCT03814603|Drug|PiB|Subjects will receive a single dose of 555 MBq of PiB and perform a dynamic 30 min PiB PET-MR scan 60 min after injection.
15878740|NCT03814577|Diagnostic Test|Total Antioxidant Status|Total Antioxidant Status values will be determined using a novel automated measurement method. The colour intensity, which can be measured spectrophotometrically, is related to the total amount of oxidant molecules present in the sample. The assay is calibrated with hydrogen peroxide) and the results are expressed in terms of micromolar hydrogen peroxide equivalent per litre.
15878741|NCT03814577|Diagnostic Test|Total Oxidant Status|Total Oxidant Status values will be determined using a novel automated measurement method. The colour intensity, which can be measured spectrophotometrically, is related to the total amount of oxidant molecules present in the sample. The assay is calibrated with hydrogen peroxide) and the results are expressed in terms of micromolar hydrogen peroxide equivalent per litre.
15878742|NCT03814577|Device|Bispectral Index|Bispectral Index is a method for depth of anesthesia and assessment of sedation. The values of bispectral index decreases with the deepening of anesthesia. The values of 40-60 characterize the appropriate depth of anesthesia.
15878743|NCT03814577|Other|Invasive arterial monitorization|Invasive arterial monitorization will be performed to right radial artery under local anesthesia to follow up hemodynamic changes and take the blood samples.
15878744|NCT03814564|Device|NIRS monitoring|Cerebral and peripheral NIRS monitoring of brain and tissue oxygenation. Of the 400 patients, a subpopulation of the first 250 adult critically ill patients (≥18 years) requiring ICU care, including both surgical and medical ICU patients with circulatory shock will be included in the NIRS-substudy. All 400 patients will be analyzed for endotheliopathy incidence, metabolomics, genetic data Representation of the study population will be ensured by enrolment of all consecutive patients at the study sites who meet the study enrollment criteria
15878745|NCT03814551|Behavioral|Signage|Placement of signage discouraging consumption of beverages with added sugar
15878746|NCT03814525|Radiation|Photobiomodulation|PBM will be applied with extra and intraoral LED devices. The LED plates speed up the treatment as they deliver all the energy at once, having the advantage of radiating several points at the same time. The applications of both will occur in the following experimental periods after the end of the surgeries: immediate postoperative, 1, 2, 7, 14, 30, 60 and 90 days.
15878747|NCT03814525|Radiation|Placebo Photobiomodulation|The person responsible for applying the PBM will simulate the irradiation by positioning the devices in the same locations described for the PBM group, but the equipment will be kept off
15878748|NCT03814512|Behavioral|Extended Sleep Intervention|Participants will receive an Extended Sleep Intervention (ES). Participants will be prescribed a sleep schedule that allows them to obtain approximately 1.5 h more time in bed compared to their typical sleep. Prescribed bedtimes and wake times will be determined collaboratively through discussion with participants and parents.
15878749|NCT03814486|Other|descriptive|evaluate in number and efficacy platelet transfusion at the end of life, demographic characteristic are also noted
15878750|NCT03814473|Other|Diet|"Participants provided with a brochure providing a thorough description of the diet, ~8 example recipes for each meal (i.e. breakfast, lunch, dinner, and snacks) included as a sample menu, and guidance to assist in shopping and self-preparation of food for the prescribed diet and to improve adherence. Diet consisted of following the popular paleolithic diet"
15878751|NCT03814460|Diagnostic Test|Assessment of Tone, Pain and Thickness|Evaluation of Muscle state of tension, self-reported response to mechanical pressure pain and muscle thickness. The evaluation process of muscle tone and pressure pain sensitivity will be carried out following a topographical mapping covering myotendinous and muscle belly sites in the biceps brachii and the gastrocnemius muscles
15878752|NCT03814447|Drug|anti- MESO CAR-T cells|Autologous genetically modified anti- MESO CAR transduced T cells
15878753|NCT03814447|Drug|Fludarabine|Dose: 30mg/m2/d
15878754|NCT03814447|Drug|Cyclophosphamide|Dose: 300mg/m2/d
15878755|NCT03814434|Procedure|Non-Surgical treatment|Implant and teeth surfaces decontamination through scaling and planning, Curettage, profilaxys and Oral Hygiene orientation
15878756|NCT03814434|Procedure|Surgical Treatment|Anaesthesia, Incision, curettage, Treatment of the contaminated implant surface, Irrigation with saline, Guided Bone Regeneration and suture
15878757|NCT03814421|Drug|intermittent (40mg as a bolus injection daily for 72hours)|Current guidelines recommend an intravenous bolus dose of a proton pump inhibitor(PPI) followed by continuous PPI infusion after endoscopic therapy in patients with high-risk bleeding peptic ulcers. However, recent many studies suggests intermittent low dose PPI infusion might have equal efficacy at preventing peptic ulcer hemorrhage recurrence. So, the present investigator assumed that intermittent administration of proton pump inhibitor will not be different from administration of continuous proton pump inhibitor for the prevention of rebleeding in patients with peptic ulcer bleeding. Also, intermittent proton pump inhibitor administration in patients with high risk of rebleeding (Rockall score 6 points or more) will not be different from prevention of rebleeding compared with continuous proton pump inhibitor administration.
15878758|NCT03814408|Biological|RP-L102|CD34+ enriched cells from subjects with Fanconi anemia subtype A transduced ex vivo with lentiviral vector carrying the FANCA gene, PGK-FANCA-WPRE
15878759|NCT03814395|Other|No intervention|This is an observational study without any intervention
15878760|NCT03814382|Device|Acupuncture needle|Acupuncture needle
15878761|NCT03814369|Device|AmplifEYE|AmplifEYE colonoscopy
15878762|NCT03814356|Drug|Methylphenidate|IV MPH
15878763|NCT03814343|Drug|amphotericin B in 30% DMSO|amphotericin B in 30% DMSO was given to patients in active comparators group for continuous 12 weeks.
15878764|NCT03814343|Drug|30% DMSO|30% DMSO was given to patients in placebo comparators group for continuous 12 weeks.
15878765|NCT03814330|Diagnostic Test|State-Trait Anxiety Inventory|State-Trait Anxiety Inventory measures state anxiety levels and is an easy-to-implement inventory that the individual can answer on his/her own. State-Trait Anxiety Inventory determines how the individual feels himself / herself at a given moment and under certain conditions. It is widely used in preoperative anxiety measurement
15878766|NCT03814330|Diagnostic Test|Quality of Recovery Score|Recovery Quality Score-40 (Quality of Recovery Score) and is used to measure the quality of postoperative recovery. This form consists 40 items and is divided into 5 subgroups according to various aspects of the improvement. There are a total of 40 items, 9 related to emotional state, 12 related to physical comfort, 7 related to psychological support, 5 related to physical independence and 7 items related to pain. The questionnaire is scored as a minimum of 40 to a maximum of 200.
15878767|NCT03814330|Other|Sedation/Analgesia|Patients will be performed the procedure with sedation/analgesia under the condition of spontaneous breathing.
15878768|NCT03814330|Device|Laryngeal Mask Airway|Patients will be performed the procedure with Laryngeal Mask Airway during the procedure. Laryngeal Mask Airway is a supraglottic airway device to ventilate the patients during anesthetic procedure.
15878769|NCT03814317|Drug|Inhaled Treprostinil|"Inhaled treprostinil causes dilatation of the pulmonary arteries and may help reduce the pulmonary pressures in this studied population.
~All subjects will initiate inhaled treprostinil at a dose of 3 breaths (18 mcg) four times daily. Study drug doses escalations (additional one breath four times daily) can occur every three days with a maximum dosing regimen of up to 12 breaths (72 mcg) four times daily, as clinically tolerated."
15878770|NCT03814304|Other|Personalized tDCS|The participant will receive 20, 20-minute sessions of personalized tDCS on Monday-Friday, at approximately the same time of day, over four consecutive weeks.
15878771|NCT03814304|Other|Active-Sham|The participant will receive 20, 20-minute sessions of active-sham stimulation on Monday-Friday, at approximately the same time of day, over four consecutive weeks.
15878772|NCT03814291|Drug|IBI302|0.05mg/eye;Intraocular injection
15878773|NCT03814291|Drug|IBI302|0.15mg/eye;Intraocular injection
15878774|NCT03814291|Drug|IBI302|0.5mg/eye;Intraocular injection
15878775|NCT03814291|Drug|IBI302|1mg/eye;Intraocular injection
15878776|NCT03814291|Drug|IBI302|2mg/eye;Intraocular injection
15878777|NCT03814291|Drug|IBI302|4mg/eye;Intraocular injection
15878778|NCT03814278|Behavioral|complete bed rest|Patients in this group received standard care for PPROM according to the institution protocol, including antepartum confinement to bed.
15878779|NCT03814278|Behavioral|activity restriction|Patients in this group received standard care for PPROM according to the institution protocol but to had bathroom privileges and walks to the ward canteen four times per day.
15878821|NCT03813979|Drug|Dolutegravir|Intake of a single-dose dolutegravir 50 mg tablet on an empty stomach
15879115|NCT03811704|Device|Laparoscopic surgical navigation system|We will use this navigation system to guide de liver resection.
15878780|NCT03814265|Behavioral|Laughter yoga|440/5000 Laughter yoga; It is an exercise program that combines breathing techniques with unconditional laughter. During the sessions, laughter is simulated by hand clapping and warm-up exercises and by eye contact with other members in the group and by playing childish games with group members. Most of the time this simulation turns into genuine and contagious laughter. Laughter yoga is based on the argument that the brain cannot distinguish between real and unreal laugh.
15878781|NCT03814252|Device|MRI-TULSA|"The technology is developed to ablate targeted prostate tissue through transurethrally inserted probe that transmit ultrasound energy under MRI guidance and control. The therapeutic endpoint of this method is thermal coagulation of prostate tissue.
~TULSA-PRO (Profound Medical Inc, Toronto, Canada): PAD-105, integrated into a 3 Tesla MR-system (Ingenia 3.0 Tesla, Philips Healthcare, Best, Netherlands)"
15878782|NCT03814239|Other|protocol|In patients of Group Protocol , basal crystalloid infusion was started at 4 ml/kg/h right after general anesthesia induction and intubation. ClearSight System (Edwards Lifesciences Cop, Irvine, CA, USA) was used to measure stroke volume variation and cardiac output, continuously and noninvasively through finger- cuffed technology. If SVV was >15% rapid crystalloid bolus of 10ml/kg or 4ml/kg colloid bolus were administered until it reached a value of ≤15%. After two consecutive fluid boluses SVV remained >15%, administration of noradrenaline infusion was considered.
15878783|NCT03814226|Other|Evaluation of headache inducing capabilities of PACAP38|We wish to investigate the headache inducing capabilities of PACAP-38, a vasoactive peptide, over a 20 minute infusion. As PACAP-38 casues visible vasodilation, another vasoactive peptide, called VIP will be used as an active comparator.
15878784|NCT03814213|Other|CGA|Multi-level Health assessment
15878785|NCT03814213|Other|tailored care|Tailored care based on problems identified by CGA
15878786|NCT03814200|Drug|Saline|Single i.v. infusion of 100 mL saline 0.9% for 30 min
15878787|NCT03814200|Drug|ACT-246475|Single s.c. dose of 4 mg ACT-246475 in the thigh under fasting conditions
15878788|NCT03814200|Drug|rifampicin|Single i.v. infusion of 600 mg rifampicin (100 mL) for 30 min
15878790|NCT03814148|Drug|LENINGRADO 5 association|1 coated sustained-release tablet, oral, once a day.
15878791|NCT03814148|Drug|Natrilix® SR|1 coated sustained-release tablet, oral, once a day.
15878792|NCT03814148|Other|Natrilix SR Placebo|1 coated sustained-release tablet, oral, once a day.
15878793|NCT03814148|Other|Leningrado 5 association Placebo|1 coated sustained-release tablet, oral, once a day.
15878794|NCT03814135|Drug|Hipnos 3|1 tablet, oral, once a day.
15878795|NCT03814135|Drug|Hipnos 5|1 tablet, oral, once a day.
15878796|NCT03814135|Other|Hipnos 5 Placebo|1 tablet, oral, once a day.
15878797|NCT03814135|Other|Hipnos 3 Placebo|1 tablet, oral, once a day.
15878798|NCT03814122|Behavioral|Action-based cognitive remediation|Action-Based Cognitive Remediation (ABCR) is a new program that was developed to address the challenges of transferring cognitive gains to improved quality of life and reduced disability. ABCR combines traditional cognitive training with an added behavioural component (e.g., role-plays, simulations of real world tasks) to foster learning through rehearsal and procedural memory which increases the likelihood of participants bridging cognitive strategies into real-world activities. ABCR also includes goal setting and behavioural activation procedures to stimulate transfer of in-session gains to everyday life changes.
15878799|NCT03814122|Other|Waitlist Control Group|Receive treatment-as-usual through regular early psychosis programming.
15878800|NCT03814109|Drug|LENINGRADO association|1 coated sustained-release tablet, oral, once a day.
15878801|NCT03814109|Drug|Indapamide SR 1.5 MG|1 coated sustained-release tablet, oral, once a day.
15878802|NCT03814109|Drug|Levamlodipine 2.5/ 5 mg|1 tablet, oral, once a day.
15878803|NCT03814109|Other|Leningrado association Placebo|1 coated sustained-release tablet, oral, once a day.
15878804|NCT03814109|Other|Indapamide SR Placebo|1 coated sustained-release tablet, oral, once a day.
15878805|NCT03814109|Other|Levamlodipine placebo|1 tablet, oral, once a day.
15878806|NCT03814096|Diagnostic Test|Syphilis Health Check POC-test (Diagnostics Direct LLC, NJ)|Syphilis Health Check (SHC) POC-test is a treponemal POC-test based on 3d generation enzyme immunoassay (EIA) method detecting both Immunoglobulin G (IgG) and Immunoglobulin M (IgM) antibodies.
15878807|NCT03814083|Device|Active-tDCS|Active-tDCS over 10 sessions in 2 weeks (once per day, for 10 consecutive working days), while performing the executive function training tasks. Also, participants will complete an online cognitive training program while they receive active tDCS stimulation for 10 training sessions. The training session will last for 20 minutes and the online cognitive training program is comprised of 5 exercises targeting at information processing speed and executive function capacities. Each exercise lasts for approximately 4 minutes, totaling approximately 20 minutes.
15878808|NCT03814083|Device|Sham-tDCS|Sham-tDCS stimulation over 10 sessions in 2 weeks (once per day, for 10 consecutive working days), while performing the executive function training tasks. Also, participants will complete an online cognitive training program while they receive sham-tDCS stimulation for 10 training sessions. The training session will last for 20 minutes and the online cognitive training program is comprised of 5 exercises targeting at information processing speed and executive function capacities. Each exercise lasts for approximately 4 minutes, totaling approximately 20 minutes.
15878809|NCT03814083|Other|Wait-list|No intervention
15878810|NCT03814070|Procedure|Fiber-reinforced framework|Glass fiber- reinforced framework is to be picked up over the implant abutments to strengthen the full arch acrylic restorations
15878811|NCT03814070|Procedure|No framework|Non-reinforced acrylic full arch prosthesis is to be picked up directly over the implant abutments.
15878812|NCT03814057|Diagnostic Test|24 hour urine creatinine excretion|two age corrected calculations of creatinine height index were obtained
15878813|NCT03814044|Device|PEEK Suture Anchors|Subjects who have undergone hip joint repair using PEEK Suture Anchors: Bioraptor Knotless Suture Anchor and SpeedLock Hip
15878814|NCT03814031|Other|NO internvention|NO internvention
15878815|NCT03814005|Drug|Azacitidine|Azacitidine subcutaneous or intravenous injection.
15878816|NCT03814005|Drug|Pevonedistat|Pevonedistat intravenous infusion.
15878817|NCT03814005|Drug|Docetaxel|Docetaxel intravenous infusion.
15878822|NCT03813966|Diagnostic Test|Sofia Influenza A+B FIA|The Nasal Swab Home Collection Kit (NSHC Kit) provides the materials and training needed for you to safely collect a nasal swab at home. The sample can then be delivered to a designated test site for influenza testing.
15878823|NCT03813953|Procedure|Liver resection|Resection of diseased liver
15878824|NCT03813940|Biological|HPV Vaccine,135μg/0.5ml|HPV vaccine (135μg/0.5ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule
15878825|NCT03813940|Biological|HPV Vaccine,270μg/1.0ml|HPV vaccine (270μg/1.0ml) administered intramuscularly according to a 0, 1, 6 month vaccination schedule
15878826|NCT03813927|Dietary Supplement|Vitamin D|Supplementation with tablet 170 μg Vitamin each day.
15878827|NCT03813927|Dietary Supplement|Placebo|Placebo with tablet 20 μg Vitamin each day.
15878828|NCT03813914|Dietary Supplement|Sineos|glycyrrhizic acid 38 mg + Cinnamomum Zeylanicum 150 mg + corosolic acid 480 mcg 2 pills per day
15878829|NCT03813901|Other|Samalochana Counselling|Counselling program was individual, based on advaita vedanta and traditional philosophical grounds to answer individual fears, concerns,conflicts and difficulties in order to cope and recover.
15878830|NCT03813901|Other|Wait list control|Wait list had no intervention offered during the study period. Afterwards, they were offered the counselling for the same duration.
15878831|NCT03813888|Other|Arsha Vidya chldren's Group|Yoga, Vedic chants, Vedant sessions, Gita sessions and group activities within the Gurukulam (centre)
15878832|NCT03813888|Other|Usual Activity group|Usual after school activities at home.
15878833|NCT03813875|Drug|Fentanyl|The investigators assess the depth of anesthesia based on bispectral index (BIS) and modified observer's assessment/alertness scale (MOAA/S) after routine drug regimen is given. BIS is maintained between 40 and 60 and MOAA/S less than 1. The drug doses are given as a part of routine anesthesia practice and is identical regardless of study participation. Typical fentanyl ranged from 0~200mcg according to patient condition. The timing and doses are recorded for backend analysis. At the conclusion of the surgery, the patient is observed in the operation room until return of consciousness before sending them to the recovery unit.
15878834|NCT03813875|Other|Bispectral index (BIS) and analgesia nociception index (ANI)|After giving routine anesthetic medications, the investigators assess the depth of anesthesia based on bispectral index (BIS) and modified observer's assessment/alertness scale (MOAA/S). BIS is maintained between 40 - 60 and MOAA/S less than 2. The vital signs, BIS, analgesia nociception index (ANI) are recorded automatically and continuously through computerized software. ANI is used to observational purposes only and do not guide anesthetic management in our protocol. Upon conclusion of the surgery or examination, the patient is observed until return of consciousness (MOAA/S = 5) before sending them to the recovery unit.
15878835|NCT03813875|Drug|alfentanil|The investigators assess the depth of anesthesia based on bispectral index (BIS) and modified observer's assessment/alertness scale (MOAA/S) after routine drug regimen is given. BIS is maintained between 40 and 60 and MOAA/S less than 2. The drug doses are given as a part of routine anesthesia practice and is identical regardless of study participation. Typical alfentanil ranged from 0~1000mcg according to patient condition. The timing and doses are recorded for backend analysis. At the conclusion of the examination, the patient is observed in the examination room until return of consciousness before sending them to the recovery unit.
15878836|NCT03813875|Drug|Propofol|The investigators assess the depth of anesthesia based on bispectral index (BIS) and modified observer's assessment/alertness scale (MOAA/S) after routine drug regimen is given. BIS is maintained between 40 and 60 and MOAA/S less than 2. The drug doses are given as a part of routine anesthesia practice and is identical regardless of study participation. Typical propofol ranged from 0~200mg according to patient condition. The timing and doses are recorded for backend analysis. At the conclusion of the surgery or examination, the patient is observed in the surgery or examination room until return of consciousness before sending them to the recovery unit.
15878837|NCT03813875|Drug|sevoflurane|The investigators assess the depth of anesthesia based on bispectral index (BIS) and modified observer's assessment/alertness scale (MOAA/S) after routine triple drug regimen is given. BIS is maintained between 40 and 60 and MOAA/S less than 1. The drug doses are given as a part of routine anesthesia practice and is identical regardless of study participation. Typical sevoflurane concentration ranged from 0~3% according to patient condition. The timing and concentrations data are acquired for backend analysis. At the conclusion of the surgery, the patient is observed in the surgery room until return of consciousness before sending them to the recovery unit.
15878838|NCT03813875|Drug|midazolam|The investigators assess the depth of anesthesia based on bispectral index (BIS) and modified observer's assessment/alertness scale (MOAA/S) after routine drug regimen is given. BIS is maintained between 40 and 60 and MOAA/S less than 2. The drug doses are given as a part of routine anesthesia practice and is identical regardless of study participation. Typical midazolam ranged from 0~5mg in boluses according to patient condition. The timing and doses are recorded for backend analysis. At the conclusion of the examination, the patient is observed in the examination room until return of consciousness before sending them to the recovery unit.
15878839|NCT03813862|Other|Non-interventional (observational only)|
15878840|NCT03813849|Diagnostic Test|Sonographic examination of uterus after surgical evacuation|
15878841|NCT03813836|Drug|Pembrolizumab|Patients will receive best supportive care + pembrolizumab 200mg every 3 weeks for a maximum duration of 24 months
15878842|NCT03813823|Behavioral|Fear tasks|All participants will be exposed to 5 fear tasks involving spiders, with increasing fear intensity.
15878843|NCT03813810|Other|Non|There would be no interventions. Only measurements will be performed.
15878844|NCT03813797|Device|Airseal®|Medical device set to the mode Airseal®, pressure adjustment between 5 and 7 mmHg
15878845|NCT03813797|Device|Standard Insufflation|"Medical device set to the mode Standard Insufflation, pressure adjustment between 12 and 15 mmHg"
15878846|NCT03813784|Drug|SHR-1210|Subjects receive SHR-1210 intravenously, Dosage form: lyophilised powder, Strength: 200 mg /vial
15878847|NCT03813784|Drug|Capecitabine|1000 mg/m^2 administered as continuous oral twice daily (BID) of each 3-week cycle.
15878848|NCT03813784|Drug|Oxaliplatin|130 mg/m^2 administered IV Q3W on Day 1 of each 3-week cycle.
15878849|NCT03813784|Drug|Apatinib|250 mg administered as continuous oral once daily (QD) of each 3-week cycle.
15878850|NCT03813771|Drug|Benepali|Benepali will be adminstered subcutaneously at a dose of 50mg weekly and discontinued at the primary endpoint (24 weeks).
15878851|NCT03813771|Drug|Sulfasalazine|Sulfasalazine will be added at follow up visits (T2T care) if the subject fails to achieve low disease activity,administered orally at a dose of 1g twice daily.
15878852|NCT03813771|Drug|Methotrexate|Methotrexate will be administered orally at a starting dose of 15mg weekly. It may be increased in line with T2T care (to a maximum of 25mg) over the 24 weeks.
15878853|NCT03813771|Drug|Hydroxychloroquine|Hydroxychloroquine will be added at follow up visits (T2T care) if the subject fails to achieve low diseaseactivity, administered at a dose of 200mg daily.
15878854|NCT03813758|Diagnostic Test|wrinkle test|soaking in 40 deg water for 40 min. every 10 min the hand will be photo
15878855|NCT03813745|Other|early denudation|COCs will be denudated in 30 min after oocyte retrieval
15878856|NCT03813745|Other|late denudation|COCs will be denudated 2 hr after oocyte retrieval
15878857|NCT03813732|Procedure|orbital fracture|using the trans-conjunctival approach alone in restoring the esthetics compared with using it along in addition to lateral canthotomy which is important in providing wider surgical area
15878858|NCT03813706|Procedure|lymph node dissection|The right cervical central compartment VI is subdivided into right cervical central VI-1 subzone and VI-2 subzone. Right central VI-1 subzone lies anterior to the RLN bounded by the hyoid bone superiorly, the suprasternal notch inferiorly, the inner edge of the common carotid artery laterally, and the midline of the trachea medially. Right central VI-2 subzone lies posterior to the right RLN. The superior, inferior, lateral, and medial borders are the laryngeal entry points of RLN, the intersection of the RLN with the innominate artery (near the right apical pleura), the inner edge of the common carotid artery, and esophagus, respectively. The floor of right central VI-2 is the prevertebral fascia.
15878859|NCT03813693|Other|towels impregnated with 2% chlorhexidine gluconate|"The first TICHG should be used on the neck, chest and abdomen; The second TICHG should be used on the right upper limb, start at the shoulder; The third TICHG was intended for the upper left limb; The fourth TICHG should be used on the neck and chest; The fifth TICHG was for the right lower limb; The sixth TICHG should be used on the lower left limb.
~2) Time of application: use six TICHGs the night before surgery and the six remaining on the morning of surgery.
~3) After the hygiene of each member, discard the TICHG. After use of TICHG, allow the product to dry on the skin. Do not use bath towels to dry yourself and wear clean clothes."
15878860|NCT03813693|Other|chlorhexidine gluconate 2% liquid|Spread the product on the skin during the bath and massage for 3 minutes, so that it is distributed equally to all parts of the body (except the face, hair and intimate area). Then rinse with water and dry with a clean, dry towel, and wear clean clothes.
15878861|NCT03813680|Other|Passive Vertebral Mobilization|Posteroanterior glides was given to cervical spine using Maitland method along with routine physiotherapy comprising thermotherapy with Hot Packs 15 minutes, Transcutaneous Electrical Nerve Stimulation (TENS) 15 minutes,Isometric neck exercises,Education on precautions and postural care
15878862|NCT03813680|Other|PNF exercise|The subjects was given PNF exercises comprising PNF diagonal patterns for neck along with routine physiotherapy comprising thermotherapy with Hot Packs 15 minutes, Transcutaneous Electrical Nerve Stimulation (TENS) 15 minutes,Isometric neck exercises,Education on precautions and postural care
15878863|NCT03813680|Other|Routine Physiotherapy|Thermotherapy with Hot Packs 15 minutes, Transcutaneous Electrical Nerve Stimulation (TENS) 15 minutes,Isometric neck exercises,Education on precautions and postural care
15878864|NCT03813667|Behavioral|Intervention FamPALcare|"The FamPALcare intervention includes all standard care information on R-ALD home care plus 2 weeks of EOLPC coaching by community nurses experienced in EOLPC. The nurse uses the Conversation Ready pamphlet to guide discussion of EOL preferences. The nurse will: (1) support the patient and family in making decisions about EOL care options based on their preferences; (2) discuss options for EOL care when the patient's R-ALD symptoms become severe; (3) encourage completion of the advance directive forms at next physician appointment. The nurse will use teach-back processes to ensure that FamPALcare discussions are clear."
15878865|NCT03813654|Behavioral|8-h Afternoon-Evening Sleep|8 consecutive hours time in bed during the afternoon/evening.
15878866|NCT03813654|Behavioral|8-h Free Sleep|8 consecutive hours time in bed at any time.
15878867|NCT03813641|Drug|Raltitrexed|Experimental: Oxaliplatin + Raltitrexed + Bevacizumab The above schemes are repeated every three weeks. After 8 cycles, such as CR, PR or SD, the regimen is changed to Raltitrexed (3mg/m2, intravenous drip for 15 minutes, d1)+bevacizumab (7.5mg/kg, intravenous drip, d1). The regimen is repeated every 3 weeks until the disease progresses.
15878868|NCT03813641|Drug|Capecitabine|Other: Oxaliplatin + Capecitabine + Bevacizumab The above schemes are repeated every three weeks. After 8 cycles, such as CR, PR or SD, the regimen is changed to Capecitabine (1000mg/m2 po. d1-14)+bevacizumab (7.5mg/kg, intravenous drip, d1). The regimen is repeated every 3 weeks until the disease progresses.
15878869|NCT03813628|Other|polished celtra press full coverage crown|a full coverage crown in esthetic area made from celtra press ceramic( zirconia reinforced lithium silicate) and finished by just polishing
15878870|NCT03813628|Other|glazed celtra press full coverage crowns|a full coverage crown in esthetic area made from celtra press ceramic( zirconia reinforced lithium silicate) and finished by glazing
15878871|NCT03813628|Other|contralateral natural teeth|the polished and glazed all ceramic crowns will be compared by the contralateral natural teeth
15878872|NCT03813615|Behavioral|treadmill walking (Proof-of-Concept)|Individualized, progressive aerobic training consisting of treadmill walking for a total of 150 mins/wk delivered over 5 sessions/wk following a linear dosing schedule for a minimum of 2 weeks. All aerobic training treatment will be implemented and may be monitored using TeleEx. Participants may also perform up to two aerobic training sessions per week in an unsupervised home-based setting. Patients will be provided with Appendix J - Unsupervised Home-Based Exercise Recording Form and Appendix K - Unsupervised Home-Based Exercise Instructions to record their sessions. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology.
15878923|NCT03813199|Drug|Methotrexate|MTX ≥ 10 mg/week will be given at previous dose regimen kept stable throughout the study
15878924|NCT03813186|Drug|ASTX727 + Day 2 Food|ASTX727 is an oral drug product composed of a fixed-dose combination of cedazuridine (E7727), a CDA inhibitor, and decitabine. Food is a high-calorie, high-fat breakfast meal of 800-1000 calories given on Day 2.
15879260|NCT03810495|Drug|naltrexone implant|1.8 g implant containing 60% naltrexone
15878873|NCT03813615|Behavioral|treadmill walking Dose-Finding / Escalation|Six doses of aerobic training ( 90mins/wk, 150 mins/wk, 225 mins/wk, 300 mins/wk & 450mins/wk) delivered following either a standard linear (i.e., each dose of exercise is performed at the same intensity & duration) or non-linear (i.e., exercise dose is continually altered & progressed in conjunction with appropriate rest/recovery sessions across the entire intervention period) dosing schedule 3 to 6 times weekly (over a 7-day period) for a minimum 2 weeks. Aerobic training treatment will be implemented & may be monitored using TeleEx. Patients may also perform up to three aerobic training sessions per week in an unsupervised home-based setting. Patients will be provided a plan for their unsupervised session(s) verbally or via Portal Secure Messaging (PSM), as appropriate.
15878874|NCT03813615|Behavioral|treadmill walking Phase 1b: Dose-Expansion|Individualized, progressive aerobic training consisting of treadmill walking delivered to achieve the recommended phase 2 dose (RP2D) identified in the phase 1a trial for a minimum of 2 weeks. All aerobic training treatment will be implemented and may be monitored using TeleEx Participants may also perform up to two aerobic training sessions per week in an unsupervised home-based setting. Patients will be provided with Appendix J - Unsupervised Home-Based Exercise Recording Form and Appendix K - Unsupervised Home-Based Exercise Instructions to record their sessions.. General physical activity as well as exercise performed outside of the structured treatment sessions will be evaluated via continuous monitoring using MSK approved telemedicine / wireless technology.
15878875|NCT03813602|Drug|Cannabis Sativa|750 mg cannabis cigarette with 12.5% THC
15878876|NCT03813576|Diagnostic Test|Self-collected HPV vaginal swab|Patients will be instructed on how to collect a vaginal swab on themselves which will then be processed for presence of HPV DNA.
15878877|NCT03813563|Drug|RL|lactated Ringer's
15878878|NCT03813563|Drug|PLA|PlasmaLyte
15878879|NCT03813550|Diagnostic Test|Fecal and blood samples|Fecal samples for intestinal microbiota analysis; Blood and fecal samples for assessment of various forms of vitamin K
15878880|NCT03813537|Other|Phone Call|The experimental group will receive a phone call 3-days post procedure and asked questions based on the most frequent indications for readmission after colorectal surgery.
15878881|NCT03813524|Device|Cardiovalve Transfemoral Mitral Valve|The Cardiovalve Transfemoral Mitral Valve System is intended for use symptomatic patients with severe mitral regurgitation who are at elevated risk for surgical mitral valve repair or replacement and who are anatomically eligible for transfemoral mitral valve replacement with transseptal access to the left atrium.
15878882|NCT03813498|Behavioral|HCV articles|The intervention group receive a targeted short article on HCV from WeChat weekly.
15878883|NCT03813498|Behavioral|general health articles|The control group receive a general health article with no mention of HCV from WeChat weekly.
15878884|NCT03813485|Other|Dry Needling in upper trapezius|"The following criteria are required for a patient to have latent TrPs: the presence of a palpable taut band in the upper trapezius muscle, the presence of a hypersensitive spot in the taut band, a palpable or visible local twitch on snapping palpation, and a no familiar reproduction of referred pain elicited by palpation of the sensitive spot.
~Dry needling is performed with solid filiform needles (0.30x30 mm), these needles are sterile and separately packaged. Needles are not reused and are immediately deposited in a needle container after usage. Patients receive dry needling in latent myofascial trigger point (LTRs) in upper trapezius. The needle is penetrated into the muscle fibers of the taut band and was moved upward and downward (fast in, fast out) in different directions with the aim to elicit LTRs"
15878885|NCT03813485|Other|Dry Needling in lower trapezius|"The following criteria are required for a patient to have latent TrPs: the presence of a palpable taut band in the lower trapezius muscle, the presence of a hypersensitive spot in the taut band, a palpable or visible local twitch on snapping palpation, and a no familiar reproduction of referred pain elicited by palpation of the sensitive spot.
~Dry needling is performed with solid filiform needles (0.30x 30 mm), these needles are sterile and separately packaged. Needles are not reused and are immediately deposited in a needle container after usage. Patients receive dry needling in latent myofascial trigger point (LTRs) in lower trapezius. The needle is penetrated into the muscle fibers of the taut band and was moved upward and downward (fast in, fast out) in different directions with the aim to elicit LTRs"
15878886|NCT03813472|Device|Hydration Sensor|This device includes a hydration sensor embedded within silicone and applied to the skin with a medical grade adhesive.
15878887|NCT03813446|Device|Device: RhythmPadBP|"Detection of heart rhythm and measurement of blood pressure
~Intervention:
~Patients will start by wearing a consumer SmartWatch (Huwaei SmartWatch 2, which has a CE mark) and a 60 second reading of their wrist Photoplethysmyograph (PPG) will be recorded. This will enable us to compare the PPG from the wrist with the fingertip data collected from the RhythmPadBP.
~The watch will be cleaned with alcohol wipe in the same manner that the RhythmPadBP is cleaned between subjects use.
~Patients will be asked to place their palms of both hands on RhythmPadBP and then the underlying heart rhythm and BP will be recorded. 12-lead ECG and BP reading will be obtained by standard devices for comparison."
15878888|NCT03813433|Other|Revascularization|a procedure used to regenerate pulp dentin complex that restores the functional properties of this immature anterior teeth, prevent and resolves apical periodontitis
15878889|NCT03813420|Behavioral|Pittsburgh Sleep Quality Index (PSQI)|"The sleep quality was evaluated through the Turkish version of the PSQI containing 19 self-rated questions searching the sleep quality during the previous month. It has seven components as subjective sleep quality, sleep latency, sleep duration, sleep efficiency, sleep disturbances, use of sleep medications, and daytime dysfunction.
~Each component is scored from 0 to 3, and the Global Pittsburgh Quality of Sleep (PQS) score is the sum of the scores of the seven components that is between 0 and 21. The higher Global PQS scores indicate poor sleep quality and the cut off score for poor sleep is 5 and over."
15878890|NCT03813420|Behavioral|International Physical Activity Questionnaire (IPAQ)|The physical activity of the participants was assessed through the Turkish version of the International Physical Activity Questionnaire -Short Form (IPAQ-SF), which includes 6 questions searching the frequency (days per week) and duration (hours) of walking, as well as low, moderate and vigorous physical activity that they engaged in during the last seven days prior to survey. Vigorous physical activity, defined by the questionnaire, referred to intense exercise that resulted in very rapid breathing and an elevated heart rate (e.g. intense weight lifting, aerobics, running, and cycling). Moderate physical activity was defined as less intense exercise that slightly heightened breathing and heart rate (e.g. less exertive cycling, fast walking, and light weight lifting).
15878891|NCT03813420|Behavioral|The Short Form 36 Health Survey (SF-36)|The Turkish version of SF-36 was used to understand the health related quality-of -life (HRQOL) of the participants over the past four weeks in eight health concepts: limitations in physical activities because of health problems; limitations in social activities because of physical or emotional problems; limitations in usual role activities because of physical health problems; bodily pain; general mental health (psychological distress and well-being); limitations in usual role activities because of emotional problems; vitality (energy and fatigue); and general health perceptions. Additionally, the psychometric evaluation of the SF-36 generated two summary scores as the Mental Health Component Score and the Physical Health Component Score that the higher scores indicate better HRQOL.
15878892|NCT03813407|Drug|Sodium Zirconium Cyclosilicate (SZC) Reduced Dose Level|"Sodium Zirconium Cyclosilicate (SZC) Dose:
~To be considered by the iDMC in consultation with the Sponsor, if de-escalation is indicated by evaluation of safety/tolerability data"
15878893|NCT03813407|Drug|Sodium Zirconium Cyclosilicate (SZC) Dose Level 1 (DL1)|Sodium Zirconium Cyclosilicate (SZC)Paediatric dose based on body weight equivalent to an adult 5 g TID (CP) or QD (MP/LTMP) dose
15878894|NCT03813407|Drug|Sodium Zirconium Cyclosilicate (SZC) Dose Level 2 (DL2)|Sodium Zirconium Cyclosilicate (SZC) Paediatric dose based on body weight equivalent to an adult 10 g TID (CP) or QD (MP/LTMP) dose
15878895|NCT03813407|Drug|Sodium Zirconium Cyclosilicate (SZC) Dose Level 3 (DL3)|Sodium Zirconium Cyclosilicate (SZC) To be considered by the iDMC in consultation with the Sponsor if further dose escalation/de-escalation is indicated by evaluation of safety/tolerability and efficacy data
15878896|NCT03813407|Drug|Sodium Zirconium Cyclosilicate (SZC) Dose During 28 Day Maintenance Phase|A 28-day MP during which Sodium Zirconium Cyclosilicate ( SZC) or placebo is administered in a randomised, double-blind manner orally once daily (QD) to maintain normokalaemia in particpants from 2 to <18 years. Participants aged <2 years will continue treatment in the MP with open-label QD oral SZC active treatment if medically indicated by the treating physician.
15878897|NCT03813394|Drug|pembrolizumab|-Pembrolizumab in Solution for Injection
15878898|NCT03813394|Drug|bevacizumab|"Bevacizumab in Concentrate for Solution
~Bevacizumab in Concentrate for Solution"
15878899|NCT03813381|Behavioral|Calorie and protein restriction diet|"Patient in intervention arm will be given individualized dietary advice on the basis of WCRF/AICR recommendations. The aim of healthy dietary advice will be the reduction of patient's total daily calorie intake up to 600 kcal below their energy requirements and 0.8g of protein/Kg body weight mostly form plant-origin food.
~Patients, periodically, will meet the dietitian for a 45-minute nutritional counselling session and a trained nurse for a 15-minute health coaching session.
~Each patient in the IA will be involved in at least three 4-hour cooking classes.
~Patients in the IA, after a medical/cardiac evaluation to assure their physical ability for exercise, will attend Nordic walking sessions of moderate intensity two times per month during the 24 months of intervention."
15878900|NCT03813368|Procedure|Whipples pancreatico-duodenectomy|Classic whipples and pylorus preserving
15878901|NCT03813355|Device|transcranial Direct Current Stimulation (tDCS)|transcranial Direct Current Stimulation (tDCS) during 20 sessions
15878902|NCT03813342|Behavioral|Gait training with visual feedback of joint kinematics|Gait training will be accomplished using a Woodway treadmill. The visual feedback will contain information about the real-time lower-limb joint angles. We will instruct participants to use the feedback to reach a target walking pattern.
15878903|NCT03813329|Dietary Supplement|Modified Sodium Bicarbonate|4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of sodium bicarbonate
15878904|NCT03813329|Dietary Supplement|Acute Sodium Bicarbonate|3 progressively larger doses of calcium carbonate followed by one acute dose of sodium bicarbonate (300 mg/kg)
15878905|NCT03813329|Dietary Supplement|Calcium carbonate (placebo)|4 progressively larger doses (110 mg·kg-1 - 200 mg·kg-1) of calcium carbonate
15878906|NCT03813316|Drug|DPP-4 inhibitor|Adding sitagliptin (DPP-4i) add-on using a fixed-dose combination with metformin (Janumet® 50/1000 mg BID).
15878907|NCT03813316|Drug|SGLT2 inhibitor|Adding ertugliflozin (SGLT2i) add-on using a fixed-dose combination with metformin(Segluromet® 2.5/1000 mg BID)
15878908|NCT03813316|Drug|SGLT2 inhibitor and DPP-4 inhibitor|Adding both a DPP-4i as Fixed dose combination (Janumet) plus SGLT2i ertugliflozin (steglatro) as add-on to metformin.
15878909|NCT03813303|Drug|Midazolam|Administration of midazolam by anesthesiologist for sedation.
15878910|NCT03813303|Drug|Fentanyl|Administration of fentanyl by anesthesiologist for sedation.
15878911|NCT03813303|Drug|Propofol|Administration of propofol by anesthesiologist for sedation.
15878912|NCT03813290|Device|Neuro-technological Intervention|During the intervention sessions, participants will don a head-mounted VR display set and a mobile EEG-biosensor. Each session will begin with a brief audio-guided mindfulness practice, follow by a 15 minutes VR game. Game performances will be influenced by individual's level of anxiety arousal and ability to regulate it.
15878913|NCT03813277|Drug|Dexmedetomidine|infusion
15878914|NCT03813264|Other|Routine outcome measures (ROM)|The proposed study consists of two complementary processes: the first is the routine collection of clinical data using ROM; The second process is MATRIX-based intervention that is expected to improve the course of treatment.
15878915|NCT03813251|Device|ForConti Contix Fecal Incontinence Management System (FIMS)|Use the device for up to 12 hours per use for 4 weeks
15878916|NCT03813238|Drug|Deutetrabenazine|Dosage ranging from 6 mg to 48 mg.
15878917|NCT03813238|Drug|Placebo|Dosage ranging from 6 mg to 48 mg.
15878918|NCT03813225|Other|Bilateral serratus Intercostal plane Block|Will be performed by echo guided one puncture in the fifth costal arch with anterior axilary line, where the tip of the needle will be guided until it reaches a point above the external intercostal muscle, below the anterior serratus above the costal arch where they will be administered 21 ml of anesthesic mass, (20 ml of levobupivacaine 0.375 and 1 mg (2mg) of dexamethasone.)
15878919|NCT03813212|Device|MRI|Magnetic resonance imaging. Trans-abdominal sonography (TAS) and transvaginal sonography (TVS) will be performed using a 3.5 or 5 MHz transabdominal convex transducer and a 7 MHz trans-vaginal transducer.
15878920|NCT03813199|Drug|ABX464 50mg|ABX464 is a new anti-inflammatory drug
15878921|NCT03813199|Drug|Matching Placebo|placebo matching with ABX464
15878922|NCT03813199|Drug|ABX464 100mg|ABX464 is a new anti-inflammatory drug
15881183|NCT03795792|Dietary Supplement|Curcumin|Will be provided in capsules
15878925|NCT03813186|Drug|ASTX727 + Day 4 Food|ASTX727 is an oral drug product composed of a fixed-dose combination of cedazuridine (E7727), a CDA inhibitor, and decitabine. Food is a high-calorie, high-fat breakfast meal of 800-1000 calories given on Day 4.
15878926|NCT03813173|Procedure|lymph node dissection|The patient was operated under general anesthesia with cervical hyper extension. The affected side or bilateral glandular lobes were resected routinely, which was confirmed as PTC by frozen section. Then one or both central lymph node dissection were separately packed and sent for examination. Scope of lymph node dissection in central carotid region: hyoid bone at the upper border, anonymous artery at the lower border, bilateral common carotid artery at the inner edge, shallow from the superficial layer of deep cervical fascia, deep to the deep layer of deep cervical fascia (anterior fascia). The right recurrent laryngeal nerve (RLN) passes through the central area of the right neck and should be specially protected.
15878927|NCT03813160|Drug|Lenabasum 20 mg|oral capsule
15878928|NCT03813160|Drug|Lenabasum 5 mg|oral capsule
15878929|NCT03813160|Drug|Placebo|oral capsule
15878930|NCT03813147|Drug|Azacitidine|Given IV
15878931|NCT03813147|Drug|Cytarabine|Given intrathecally and IV
15878932|NCT03813147|Drug|Fludarabine Phosphate|Given IV
15878933|NCT03813147|Drug|Methotrexate|Given intrathecally
15878934|NCT03813147|Drug|Pevonedistat|Given IV
15878935|NCT03813147|Drug|Therapeutic Hydrocortisone|Given intrathecally
15878936|NCT03813134|Procedure|Percutaneous coronary intervention (PCI)|Primary PCI or early/immediate PCI for NSTEMI will be undertaken according to recommended Guideline standards of care. This will include appropriate pre-loading with dual anti-platelet therapy, a preferred radial approach, intra-procedural anti-coagulation (with measure of ACT if considered appropriate every 30 minutes) and the use of drug eluting stents. Treatment will be delivered essentially to the culprit vessel only. A successful procedure will be one considered to have achieved TIMI 2-3 flow and residual stenosis < 50%. PCI failure will not be an exclusion itself from the trial.
15878937|NCT03813134|Other|Pharmacological Support|Use of pharmacological agents (Norepinephrine, Dobutamine, Levosimendan) according to ESC Guidelines to maintain mean arterial pressure >75 mmHg in accordance with recognised standards of care. Changes in pharmacotherapy will NOT be regarded as escalation therapy. However the number of and dose of inotropes will be documented in the CRF.
15878938|NCT03813134|Device|VA-ECMO|"Following PCI of the culprit lesion, patients will have ECMO initiated as soon as echocardiography (to exclude mechanical causes) has been completed, once they have been assessed as having failed to improve (with the aim to start ECMO as early as possible from 30 mins after completed P-PCI procedure ad fully established within 6 hours after randomisation).
~Peripheral Veno-arterial ECMO will be employed with a flow rate according to individual patient needs. Other methods of LV unloading, distal limb perfusion, maintenance of ejection/aortic valve opening and anti-coagulation will be instituted as per sites' usual care.
~A minimum 24 hours be allocated to the randomised therapy in order that strategy failure is demonstrated but this will be at the physicians' discretion."
15878939|NCT03813121|Drug|midazolam intravenous infusion|Participants will receive a single drug infusion
15878940|NCT03813121|Drug|placebo intravenous infusion|Participants will receive a single placebo infusion
15878941|NCT03813121|Drug|ketamine intravenous infusion|Participants will receive a single drug infusion
15878942|NCT03813108|Biological|CPS-immunization|Subjects will be immunized 3 times by exposure to the bites of P. falciparum NF135.C10 infected mosquitoes while taking mefloquine profylaxis.
15878943|NCT03813108|Biological|malaria challenge infection, P. falciparum NF135.C10|Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum NF135.C10 sporozoites.
15878944|NCT03813108|Biological|malaria challenge infection, P. falciparum NF54|Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum NF54 sporozoites.
15878945|NCT03813108|Biological|CPS-immunization (A/L)|Subjects will be immunized 3 times by exposure to the bites of P. falciparum NF135.C10 infected mosquitoes and receive presumptive treatment with artemeter/lumefantrine initated on day 7 after each immunization.
15878946|NCT03813108|Drug|Atovaquone / Proguanil Oral Tablet [Malarone]|All participants will be treated with atovaquone/proguanil (1000/400 mg (= 4 tablets) 1×/day during 3 consecutive days) when they develop a malaria infection or on day 28 after malaria challenge infection.
15878947|NCT03813095|Drug|APH-1501|The investigational drug product APH-1501 is CBD encapsulated in biodegradable polymer nanospheres, is a lyophilized powder intended for oral administration.
15878948|NCT03813095|Drug|Placebo|The placebo is a sterile pyrogen free lyophilized powder identical in appearance to the experimental drug product.
15878949|NCT03813082|Behavioral|Prolonged wakefulness|40 hours of prolonged wakefulness
15878950|NCT03813069|Other|IR3535|The topical repellent IR3535 (3-[N-butyl-N-acetyl]-aminopropionic acid ethyl ester) only
15878951|NCT03813069|Other|Permethrin lower dose|A fabric scarf, impregnated with the insecticide permethrin (m-Phenoxybenzyl)-cis,trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate) that has contact irritancy/spatial repellency. Dose appropriate to children of 10-20 kg.
15878952|NCT03813069|Other|Permethrin higher dose|A fabric scarf, impregnated with the insecticide permethrin (m-Phenoxybenzyl)-cis,trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate) that has contact irritancy/spatial repellency. Dose appropriate to children more than 20 kg.
15878953|NCT03813056|Drug|Glanatec|Rho kinase Inhibitor
15878954|NCT03813056|Drug|Optive, Ophthalmic Solution|artificial tears (placebo)
15878955|NCT03813056|Procedure|Descemet Membrane Endothelial Keratoplasty|Partial thickness corneal transplant that replaces only the diseased corneal endothelium and descemet membrane of the recipient.
15878956|NCT03813043|Drug|Midazolam injection|Midazolam 2mg iv to be used as starting dose using Biased coins up and down method (BCM)
15878957|NCT03813030|Procedure|Intravenous infusion of lidocaine|Lidocaine is intravenously administered in clearance visit and blood samples are taken to calculate individual clearance of each participant.
15878958|NCT03813030|Drug|"Lidocaine 2.5% and Prilocaine 2.5% cream, USP (2.5% lidocaine, 2.5% prilocaine, Actavis Pharma incorporated, USA)"|Topical application in dermal-sampling visit
15878959|NCT03813030|Drug|"Lidocorit 2%-Ampullen (Gebro Pharma Gesellschaft mit beschränkter Haftung, Austria)"|Intravenous infusion in clearance visit
15881184|NCT03795792|Dietary Supplement|Hydrolyzed collagen|Will be provided in capsules.
15878960|NCT03813030|Device|Dermal open flow microperfusion|"Dermal open flow microperfusion will be used to collect interstitial fluid in order to assess lidocaine/prilocaine concentration in the dermis.
~Interstitial fluid (ISF) sampling: 1 hour pre-dose and 12 hours post-dose"
15878961|NCT03813030|Device|Dermal Microdialysis|"Dermal microdialysis will be used to collect interstitial fluid in order to assess lidocaine/prilocaine concentrations in the dermis.
~Interstitial fluid (ISF) sampling: 1 hour pre-dose and 12 hours post-dose"
15878962|NCT03813030|Procedure|Blood sampling in dermal sampling visit|1 sample is taken pre-dose and 12 samples are taken post-dose.
15878963|NCT03813030|Procedure|Blood sampling in clearance visit|1 sample is taken pre-dose, 3 samples during intravenous infusion and 13 samples post-dose.
15878964|NCT03813004|Diagnostic Test|Reaction for gait perturbation|"Participants were subjected to four different perturbation types while walking on the treadmill:
~left treadmill belt deceleration for right leg toe off
~right treadmill belt deceleration for left leg toe off
~left treadmill belt acceleration for right leg heel strike
~right treadmill belt acceleration for left leg heel strike
~Motion analysis was conducted to analyze effect of the intervention on gait."
15878965|NCT03812991|Drug|Miacalcin Calcitonin Salmon Nasal Spray|Miacalcin nasal spray is 1 spray (200 International Units) per day administered intranasally, alternating nostrils daily
15878966|NCT03812978|Other|Smart phone application|Smart phone application including exercise videos, push notifications for exercise, questions and answers, exercise diary.
15878967|NCT03812965|Drug|Botulinum toxin type A|2 units/point of botulinum toxin type A
15878968|NCT03812939|Drug|Octreotide|Patients will receive 6-12 monthly injections every 28 (+/- 3) days.
15878969|NCT03812926|Device|Compuflo assited procedure|number of needle entry required to identify the ligamentum flavum
15878970|NCT03812913|Behavioral|psychological evaluation|"Neuropsychological and experimental tasks will assess cognitive and socio-cognitive functions.
~Questionnaires will assess psychoaffective aspects (depression, anxiety, self-esteem), and social and behavioral functioning."
15878971|NCT03812900|Drug|Echinacea purpurea alcoholic extract|Different galenic forms with Echinacea purpurea alcoholic extract from herb and roots (95:5%)
15878972|NCT03812887|Diagnostic Test|Photopatchtesting|Photopatchtesting to the sunscreen series and extended series, irradiated at both 24 and 48 hours
15878973|NCT03812874|Drug|PTX-9908 Injection|"Proposed dose cohorts:1 mg/kg, 2 mg/kg, 4 mg/kg, 8 mg/kg, and 16 mg/kg.
~Frequency:
~Phase I: one dose per day for 4 consecutive weeks (20 doses). Phase II (A)Daily Dose Regimen one dose per day for 12 consecutive weeks (60 doses). (B) Daily for first week, followed by weekly treatment Regimen One dose per day for 5 consecutive days in Week 1 (5 doses), and one dose per week till for 11 weeks (11 doses).
~Duration: 4 weeks (Phase I) and 12 weeks (Phase II)."
15878974|NCT03812874|Drug|Placebo|"water for injection
~Phase II (A)Daily Dose Regimen one dose per day for 12 consecutive weeks (60 doses). (B) Daily for first week, followed by weekly treatment Regimen One dose per day for 5 consecutive days in Week 1 (5 doses), and one dose per week till for 11 weeks (11 doses).
~Duration: 12 weeks (Phase II)"
15878975|NCT03812861|Other|CAMDS bundle|Cognitive aids for the assessment and management of deteriorating surgical patients (CAMDS). This bundle contains instructions for doctors and nursing staff to assess, manage and escalate care of deteriorating surgical patients. These management instructions will be derived from best practices that are linked with improved mortality and morbidity in surgical patients.
15878976|NCT03812848|Other|Anticoagulation Stewardship Program|"A clinical-pharmacist led anticoagulation stewardship program that includes:
~Warfarin monitoring and dosing protocol. 1a.Warfarin initial dosing algorithm. 1b.Recommended International normalized ration (INR) target and duration of Warfarin therapy by indication.
~1c.Warfarin dosage adjustment algorithms.
~1d.Management of high INR values. 2-Heparin weight-based protocol. 3-Perioperative anticoagulation use protocol. 4-Policies that address baseline and ongoing laboratory monitoring for anticoagulants.
~5-Protocol for Heparin Induced Thrombocytopenia(HIT) management. 6-Anticoagulation reversal protocol. 7-Booklet for anticoagulant drugs and all of previously prepared protocols. 8-Education programs regarding anticoagulation's therapy for health care team dealing with anticoagulation and patients."
15878977|NCT03812822|Device|Insole|Custom-made insoles which support the foot at subtalar neutral position
15878978|NCT03812809|Drug|BPI-7711|BPI-7711: 180mg, QD, oral
15878979|NCT03812796|Drug|Domatinostat|"Domatinostat is an oral tablet which will be given at a variable dose during the Phase IIA safety run in phase of the trial.
~During the Phase IIB efficacy phase of the trial patients will be treated with domatinostat at the safe and tolerated combination dose identified during the Phase IIA safety run in phase."
15878980|NCT03812796|Drug|Avelumab|Avelumab is a monoclonal antibody which is given via an intravenous infusion at a dose of 10mg/kg every two weeks on the first day of a two week cycle. (Day 1 q 14d) from Cycle 2 onwards.
15878981|NCT03812783|Procedure|Hepatic arterial infusion chemotherapy|administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
15878982|NCT03812783|Drug|Folfox Protocol|Oxaliplatin , fluorouracil, and leucovorin
15878983|NCT03812783|Drug|Sorafenib|administration of Sorafenib
15878984|NCT03812783|Procedure|Hepatic arterial infusion chemotherapy|administration of Irinotecan, Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
15878985|NCT03812783|Drug|FOLFIRINOX|Irinotecan, Oxaliplatin , fluorouracil, and leucovorin
15878986|NCT03812770|Drug|Sorafenib|Oral Sorafenib, 400mg, Bid
15878987|NCT03812770|Drug|HAIC of FOLFOX|administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
15878988|NCT03812770|Drug|HAIC of OXA|administration of Oxaliplatin via the tumor feeding arteries
15878989|NCT03812757|Diagnostic Test|Supraclavicular fossa US scanning|As previously stated.
15878990|NCT03812744|Drug|Whole coffee cherry extract (WCCE)|100mg WCCE
15878991|NCT03812744|Drug|Placebo Oral Capsule [CEBOCAP]|Silica Oxide
15878992|NCT03812731|Drug|Ropivacaine|Intraoperatively after induction of anaesthesia caudal epidural block will be administered with 0.2% ropivacaine 1-ml/kg
15878993|NCT03812731|Drug|Fentanyl Citrate|Intraoperatively after induction of anaesthesia fentanyl 1-mcg/kg/hour will be administered
15879025|NCT03812432|Device|Near-infrared fluorescence cholecystocholangiography|Device: Real-Time Fluorescence Imaging (VISERA ELITE II Imaging System). These device is used to identify anatomy, using infrared light that causes the indocianine green to fluoresce.
15878994|NCT03812718|Device|Endotracheal tube (ETT)|After induction of anaesthesia patient will be intubated with polyvinyl chloride (PVC) ETT for maintaining intraoperative ventilation. Anaesthesia will be maintained with propofol and the administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the closed-loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of GA.
15878995|NCT03812718|Device|ProSeal Laryngeal Mask Airway (PLMA)|After induction of anaesthesia ProSeal Laryngeal Mask Airway (PLMA) will be inserted for maintaining intraoperative ventilation. Anaesthesia will be maintained with propofol and the administration rate will be controlled by a feedback loop facilitated by BIS monitoring using the closed-loop anaesthesia delivery system (CLADS). A BIS value of 50 will be used as the target point for induction and maintenance of GA.
15878996|NCT03812705|Biological|fecal microbiome transplantation|"Stop antibiotics treatment 1 day before fecal microbiome transplantation;
~Fasting food 6 hours before fecal microbiome transplantation;
~Give Ondansetron intravenously 1 hour before fecal microbiome transplantation for vomiting prevention;
~Perform fecal microbiome transplantation under colonoscopy or gastroscopy;
~Perform up to 4 times if patient response;
~Stop if no response after twice fecal microbiome transplantation."
15878997|NCT03812692|Device|MATRx plus|The MATRx plus device is a feedback-controlled mandibular positioner that uses data collected during sleep to control movement of the mandible in real-time using a mandibular positioner. The test provides a prediction of the individual's response to oral appliance therapy; i.e., if the individual can treat his or her obstructive sleep apnea using a mandibular advancing oral appliance. For individuals predicted to respond to the therapy, the test also provides a mandibular position at which the appliance will be effective.
15878998|NCT03812679|Device|AMIA APD Solution Generation System|The AMIA APD Solution Generation System consists of the AMIA APD Cycler, Sharesource Platform, AMIA APD Concentrates, a disposable set, a bag tray, a Water Softener, and a Water Device (WD).
15878999|NCT03812653|Device|CPAP|Automatically-adjusting continuous positive airway pressure (CPAP) delivered using a study supplied device.
15879000|NCT03812640|Device|Vicryl suture|Corneal suture with Vicryl suture
15879001|NCT03812640|Device|Nylon suture|Corneal suture with Nylon suture
15879002|NCT03812627|Other|Blood, urine, hair, synovial fluid and peri-prosthetic tissue collections|"All inpatient subjects: following samples will be collected during hospitalization:
~Twice blood and urine collections:
~at the beginning of hospitalization: 10 ml of blood + 5 ml of urine;
~at the end of hospitalization: 5 ml of blood + 5 ml of urine. Synovial fluid collection: 1 ml Peri-prosthetic tissue collection: about 1 cm3 Hair collection: a single hair of 0.5 cm diameter"
15879003|NCT03812627|Other|Autopsy|Dead patients will be autopsied: hair, urine, blood, peri-prosthetic tissue and viscera (liver, kidney, spleen, brain, heart, lung) sampling for each autopsy.
15879004|NCT03812614|Behavioral|FAM ACT|Patient and Support Person (dyad) will receive a Diabetes Complications Risk Assessment profile and introduction session, Support Person-focused information/skills training through 4-6 extended DSME sessions, case management contacts with CHW for the remainder of a 12-month period, and guidance on how to prepare for and participate in healthcare appointments.
15879005|NCT03812614|Behavioral|I-DSME+CM|Patient only will receive a Diabetes Complications Risk Assessment profile and introduction session, 4-6 group DSME sessions, case management contacts with CHW for the remainder of a 12-month period, and guidance on how to prepare for and participate in healthcare appointments.
15879006|NCT03812601|Procedure|Simultaneous bi-atrial electroanatomic mapping and ablation|Simultaneous bi-atrial electroanatomic mapping during atrial fibrillation and during pacing from 3 different vectors at varying cycle lengths followed by pulmonary vein isolation and AcQMap guided ablation of non-pulmonary vein mechanisms.
15879007|NCT03812588|Drug|Escitalopram|Escitalopram is a Selective Serotonin Reuptake Inhibitor (SSRI) medication that appears to help with symptoms of depression by increasing the availability of specific chemicals in the brain.
15879008|NCT03812588|Drug|Placebo|A placebo (or dummy pill) is an inert (inactive) substance, typically a tablet, capsule or other dose form that does not contain an active drug ingredient.
15879009|NCT03812562|Biological|Nivolumab|Given IV
15879010|NCT03812562|Radiation|Yttrium Y 90 Glass Microspheres|Given IV
15879011|NCT03812549|Drug|Sintilimab|Patients will receive treatment with Sintilimab 200mg every 3 weeks for a maximum of 24 months.
15879012|NCT03812549|Radiation|stereotactic body radiation therapy|Radiation treatment utilized in this trial consists of SBRT with a standard doses to 30 Gy/3f
15879013|NCT03812549|Radiation|Low Dose Radiotherapy|LDRT at dose escalation levels: 2 Gy/1f, 4 Gy/2f, 10 Gy/5f with conventional external beam radiation.
15879014|NCT03812536|Other|No Void|Currently the protocol at The Ohio State University Hospital requires voiding spontaneously prior to discharge from the PACU. Our intervention group will be discharged home without having to void spontaneously as a discharge criteria.
15879015|NCT03812523|Drug|Duloxetine 60 mg qd|60 mg tablet Taken by mouth, Once Daily for 180 Days
15879016|NCT03812523|Drug|Lorcaserin|10 mg tablet Taken by mouth Twice Daily for 180 Days
15879017|NCT03812510|Drug|A-101|hydrogen peroxide topical solution 45%
15879018|NCT03812497|Behavioral|Individualized Education Program|The every participants will have individualized education program about a way of dietary control and exercise in their usual life.
15879019|NCT03812484|Behavioral|SCF Supervision|SCF Supervision entails a warning session (Orientation Hearing) where the rules of parole are laid out and parolees are told that any violation of stated parole conditions will be sanctioned with a brief jail term (typically a few days in jail). SCF Supervision includes regular random drug testing.
15879020|NCT03812484|Behavioral|Parole-as-Usual|Parolees are supervised under standard parole supervision practice in New Jersey
15879023|NCT03812458|Behavioral|website and brochure|website and brochure
15879024|NCT03812445|Dietary Supplement|Probiotics|the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus,Bifidobacterium lactobacillus,Lactobacillus paracasei,Lactobacillus rhamnosus and Lactobacillus fermentium with does of 8*10^9 Colony-Forming Units(CFU) *2/d for 3 months.
15879026|NCT03812419|Drug|Esomeprazole 40 mg|Esomeprazole 40 mg In addition, the immunosuppressant combination of CsA (Sandimmune; Novartis, East Hanover, NJ, USA), MMF (Cellcept; Roche, Basel, Switzerland) and the corticosteroid prednisolone (Solupred; Sanofi Aventis, Tours, France).
15879027|NCT03812419|Drug|Pantoprazole 40mg|Pantoprazole 40 mg In addition, the immunosuppressant combination of CsA (Sandimmune; Novartis, East Hanover, NJ, USA), MMF (Cellcept; Roche, Basel, Switzerland) and the corticosteroid prednisolone (Solupred; Sanofi Aventis, Tours, France).
15879028|NCT03812406|Procedure|French Abulatory Cesrean Section|A cesarean section performed according to the FAUCS technique
15879029|NCT03812406|Procedure|Misgav-Ladach|A cesarean section performed according to the Misgav Ladach technique
15879030|NCT03812393|Drug|Neratinib|For cycle 1 subjects will receive Neratinib 240mg daily for 21 days. For cycle 2-5, subjects will receive carboplatin AUC of 1.5 and Paclitaxel 80mg/m2 on day one in combination with Neratinib 240mg daily for 21 day.
15879031|NCT03812380|Drug|EffCaMgCit|Each sachet of EffCaMgCit will contain 19 meq or 380 mg calcium, 10 meq (122 mg) magnesium, and 50 meq total citrate.
15879032|NCT03812380|Other|Placebo|Each sachet of Placebo will contain microcrystalline cellulose, but no calcium, magnesium or citrate. Placebo will be added to 6 oz water for 1-2 minutes, to be dissolved/suspended before swallowing. The placebo will contain 400 units of vitamin D.
15879033|NCT03812354|Other|THRIVE 4L/kg/min|High-flow nasal cannula therapy with 4L/kg/min with 100% oxygen via OptiFlow by Fisher&Paykel, Auckland, New Zealand.
15879034|NCT03812354|Other|THRIVE 2L/kg/min|High-flow nasal cannula therapy with 2L/kg/min with 100% oxygen via OptiFlow by Fisher&Paykel, Auckland, New Zealand.
15879035|NCT03812341|Other|Experimental|KeraKlear Non-Penetrating Keratoprosthesis The KeraKlear is a flexible non-penetrating artificial cornea designed to be implanted through small corneal incisions in subjects with corneal opacity
15879036|NCT03812328|Drug|SelK2|I.V., single-dose
15879037|NCT03812328|Biological|Enoxaparin|SC, QD for up to 10 ± 2 days
15879038|NCT03812315|Combination Product|Propolis chewing gum|Children who will use chewing gum will be instructed to chew a gum for 20 minutes once after breakfast and another before bed time for two weeks.
15879039|NCT03812315|Combination Product|Propolis mouthwash|Children who will use mouthwash will be instructed to rinse with 10 ml for 60 seconds twice daily once after breakfast and another before bedtime for two weeks.
15879041|NCT03812289|Other|Quality-of-Life Assessment|Ancillary studies
15879042|NCT03812289|Other|Questionnaire Administration|Ancillary studies
15879043|NCT03812289|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15879044|NCT03812276|Device|Dental Implants|Dental Implants will be used according to standard routine in daily practice, according to all indications as specified by the manufacturer in the IFU (informations for use).
15879045|NCT03812263|Biological|RP-L201|CD34+ enriched hematopoietic stem cells from subjects with severe LAD-I transduced ex vivo with lentiviral vector carrying the ITGB2 gene, Chim-CD18-WPRE.
15879046|NCT03812250|Procedure|ERCP assisted trans-papillary drainage for malignant biliary obstruction|ERCP assisted trans-papillary drainage for malignant biliary obstruction
15879047|NCT03812250|Procedure|EUS-guide biliary drainage for malignant biliary obstruction|EUS-guide biliary drainage for malignant biliary obstruction
15879048|NCT03812237|Other|(EWB) Early Weight Bearing (2 Weeks Post-op)|Patient were permitted to progressively weightbear on their heel at 2 week post-op.
15879049|NCT03812224|Drug|Erenumab|Administered by subcutaneous injection once a month
15879050|NCT03812224|Drug|Placebo|Administered by subcutaneous injection once a month
15879051|NCT03812211|Dietary Supplement|Active Supplement|Examine the effects of a multi-faceted supplement comprised of vitamins, minerals and naturally occurring and plant extracts approved for consumption of in overweight/obese men and women
15879052|NCT03812211|Dietary Supplement|Placebo supplement|Examine the effects of a placebo supplement in overweight/obese men and women, compare to the active supplement
15879053|NCT03812198|Drug|LEO 32731 modified release tablet|At each dosing, subjects will swallow the appropriate number of tablets with approximately 240 mL of water at room temperature.
15879054|NCT03812198|Drug|LEO 32731 blend, hard capsule|At each dosing, subjects will swallow the appropriate number of capsules with approximately 240 mL of water at room temperature.
15879055|NCT03812198|Drug|LEO 32731 API, hard capsule|At each dosing, subjects will swallow the appropriate number of capsules with approximately 240 mL of water at room temperature.
15879056|NCT03812198|Drug|LEO 32731 soft capsule|At each dosing, subjects will swallow the appropriate number of capsules with approximately 240 mL of water at room temperature.
15879057|NCT03812198|Drug|LEO 32731 gastro-resistant capsule|At each dosing, subjects will swallow the appropriate number of capsules with approximately 240 mL of water at room temperature.
15879058|NCT03812198|Drug|LEO 32731|At each dosing, subjects will swallow the appropriate number of tablets or capsules with approximately 240 mL of water at room temperature.
15879059|NCT03812198|Other|Placebo|At each dosing, subjects will swallow the appropriate number of tablets or capsules with approximately 240 mL of water at room temperature.
15879060|NCT03812185|Device|Suctioning orogastric tube which is attached to TEE probe cover|Suctioning orogastric tube which is atttached to TEE probe cover.
15879061|NCT03812172|Drug|99mTc-PYP|10 mCi of 99mTc-PYP will be administered intravenously and imaging will be performed after 1 hour.
15879062|NCT03812159|Device|iCSPlan|"The Investigator will acquire a routine pre-operative CT-scan to help assess the synostosis severity. A week before the surgery a routine preoperative visit will be done. If the potential subject agrees to participate in the study, a presurgical plan will be built, and based on the CT scan, it will (1) quantify shape differences between pathological and healthy cranial shapes; (2) compensates for brain and cranial growth during the months between diagnosis, treatment and recovery; and (3) guides bone-cuts and bone-placement for the simplest and optimal surgical procedure.
~Finally this plan will be recorded in a software, iCSPlan, which will be reviewed by the surgeon. If it is accepted, it will be available during the surgery as a rely-on tool which may or may not be followed."
15879112|NCT03811730|Diagnostic Test|Transesophageal echocardiography|Eligible patients would be conducted both Transesophageal echocardiography and Transthoracic echocardiography to offer independent results
15879063|NCT03812146|Behavioral|PC-TIME|PC-TIME consists of five, 30-minute sessions delivered over 8 weeks. Intervention will be delivered by a behavioral health provider and will consist of brief Prolonged Exposure for PTSD integrated with aspects of the Motivational Interviewing counseling approach.
15879064|NCT03812146|Behavioral|PC-TAU|PC-TAU consists of Brief Advice intervention from their PC medical provider that is built into the electronic medical record as a mandatory response to a positive screen. In addition, patients who score positive on the AUDIT-C or PC-PTSD are offered a referral to the PCMHI provider within the PC clinic. PCMHI in VA consists of licensed, independent providers (typically psychologists or clinical social workers) providing brief assessment and interventions to veterans and consultation to other members of the PC team. PCMHI sessions are typically focused on assessment, psycho-education, and supportive counseling.
15879065|NCT03812120|Procedure|Dural closure with L-PRF|Evaluation of the safety and effectiveness of autologous blood-derived products (L-PRF) as an adjunct for dural repair
15879066|NCT03812120|Procedure|Dural closure with classical fibrin sealants|Evaluation of the safety and effectiveness of classical fibrin sealants as an adjunct for dural repair
15879067|NCT03812107|Other|Moderate Treatment Approach|The frequency of visits will be organized similarly as the intensive treatment arm (weekly, every 2 weeks, and every 4 weeks) but participants in this arm will be able to move more freely between these steps and are hypothesized to require fewer provider visits than the intensive treatment arm.
15879068|NCT03812107|Other|Intensive Treatment Approach|After stabilization on a MOUD, participants who relapse will be asked to return weekly until 2 consecutive urine drug tests are negative for opioids or other illicit drugs. Participants will then be asked to return every other week until 2 consecutive urine drug tests are negative for opioids or other illicit drugs, before being asked to return every 4 weeks. If the participant tests positive for illicit drugs while returning every other week, they will return to the beginning of the treatment plan (2 consecutive negative tests before going to every other week).
15879069|NCT03812094|Device|Enurad 400|Alarm treatment
15879070|NCT03812094|Behavioral|Basic Bladder advice|Pre-specified Basic bladder advice
15879071|NCT03812081|Device|Group A : Baska Mask Airway|Size selection is based on the manufacturer's recommendation of weight-based estimate plus clinical judgment. The Baska Mask is available in four sizes: size three (30 to 50 kg), size four (50 to 70 kg), size five (70 to 100 kg),The membranous cuff of the Baska Mask appears bulkier than the equivalent inflatable cuff on cuffed laryngeal masks. The mask can easily be decreased in size during insertion by compressing the proximal, firmer part of the mask below the airway tube, between the thumb and two fingers
15879072|NCT03812081|Device|Group B: Proseal Laryngeal Mask Airway|Proseal LMA (size 3,4,5) was used for ventilation according of patient body weight.Size selection is based on the manufacturer's recommendation of weight-based estimate plus clinical judgment.
15879073|NCT03812068|Behavioral|Long-distance developmental behavioral intervention|Long-distance learning program combined parent-mediated developmental behavioral intervention
15879074|NCT03812068|Behavioral|Developmental behavioral intervention|Parent-mediated developmental behavioral intervention
15879075|NCT03812042|Diagnostic Test|Enzyme assay and molecular sequencing|Enzyme assay and molecular sequencing on relevant samples conducted from left over blood samples
15879076|NCT03812029|Drug|EYP001a|Oral tablets
15879077|NCT03812029|Other|Placebo|Oral tablets
15879078|NCT03812016|Device|Magnetic device prototype|The device prototype comprises 1 or 2 matched pairs of one near-infrared light-emitting diode (SMT910, Epitex Inc, Kyoto, Japan) and one sensor (PD15-22C TR8, Everlight Electronics Corporation, New Taipei City, Taiwan), a permanent electromagnetic actuator (JNP-12/12, Joint Magnetic Technology Corporation, Shenzhen, China), an iron sheet, and a biosignal acquisition module. The efficacy and safety of the device prototype were assessed using the device prototype.
15879079|NCT03812003|Drug|Remifentanil|remifentanil 1mcg/kg added in 0.9% saline and diluted to 50ml
15879080|NCT03811990|Behavioral|Cleveland Clinic Stress Free Now Meditations For Healers|Phone-based meditation application
15879081|NCT03811977|Dietary Supplement|Lutein syrup|12- week dietary supplementation with lutein syrup (20 mg lutein/day)
15879082|NCT03811977|Dietary Supplement|Placebo syrup|12- week dietary supplementation with placebo syrup (0 mg lutein/day)
15879083|NCT03811964|Other|Specific light exposures|Specific light exposures using light in a wide range of intensities or different light/dark regimens
15879084|NCT03811951|Drug|Novolin R|Novolin R is a sterile, clear, aqueous, and colorless solution that contains human insulin (rDNA origin) 100 units/mL, glycerol 16 mg/mL, metacresol 3 mg/mL, zinc chloride approximately 7 mcg/mL and water for injection. The pH (potential Hydrogen) is adjusted to 7.4. Hydrochloric acid 2N (concentration) or sodium hydroxide 2N may be added to adjust pH. Novolin R vials are latex-free. The drug substance is being purchased from McKesson.
15879085|NCT03811938|Procedure|Low voltage ablation|Catheter ablation of low voltage areas in the left atrium and catheter ablation aiming for the electrical isolation of the pulmonary veins.
15879086|NCT03811938|Procedure|Pulmonary Vein Isolation|Catheter ablation aiming for the electrical isolation of the pulmonary veins.
15879087|NCT03811925|Procedure|Angioplasty and drug coated balloon of the superficial femoral artery (SFA)|In case of drug coated balloon (DCB) there should be always a predilation of the lesion with a predefined ballon (180 sec, Passeo-18). Thus, no direct DCB will be conducted. All DCB lengths (40mm to 200 mm) and Diameters (3mm to 7mm) are eligible for the Trial as long as used in the superficial femoral artery (SFA)
15879088|NCT03811925|Procedure|Angioplasty and stenting of the superficial femoral artery (SFA)|In case of stent application there should be always a predilation of the lesion with a predefined ballon (180 sec, Passeo-18). In case of stenting there should be a strong effect on vasomotion of the treated vessel area. All Stent lengths (40mm to 200 mm) and Diameters (5mm to 7mm) are eligible for the trial as long as used in the superficial femoral artery (SFA)
15879089|NCT03811912|Drug|CTP-543 QD Dose Regimen|16 mg once-daily (QD)
15879090|NCT03811912|Drug|CTP-543 BID Dose Regimen|8 mg twice-daily (BID)
15879091|NCT03811899|Diagnostic Test|18F-DCFPyL|The purpose of this study is to determine whether HG SOC are 18F-DCFPyL (=GCP-II)-avid and to compare the performance of this PET to CT and findings at time of surgery.
15879113|NCT03811717|Other|FAST+EX|Participants will perform 2-hours of low-intensity arm exercise (8 x 15 min bouts of arm ergometer exercise separated by 10 min of rest) during an 8-hour fast.
15879092|NCT03811886|Drug|Natalizumab|"Natalizumab is an FDA approved monotherapy for treatment of relapsing forms of MS. It is also indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active CD who have had an inadequate response to, or intolerance of, conventional therapies and TNF-α inhibitors.
~Traditional 3+3 escalation of Natalizumab at a weight-based dosing 2mg/kg not to exceed 300mg. If no subjects experience a dose limiting toxicity (DLT), 3 more subjects are enrolled at the next dose of 3mg/kg, not to exceed 300mg. If no subjects experience a DLT, 3 more subjects will be enrolled at the next and final dose of 4mg/kg, not to exceed 300mg.
~Phase II will continue if the subject has Complete Response (CR), Partial Response (PR) or Stable Disease (SD) of pOS, defined by RECIST 1.1 criteria after every 3 cycles after the first 6 cycles but not beyond 24 cycles. If subject has progressive disease after cycle 6, they will be removed from the study."
15879093|NCT03811873|Radiation|Thoracic spine X-Ray|All participants will receive above interventions, in addition to their standard of care. Additionally, 15 patients will undergo CT scan of the lumbar spine at baseline and 1 year follow.
15879094|NCT03811860|Diagnostic Test|Lithium level|The level of lithium in the serum
15879095|NCT03811860|Diagnostic Test|Serum Creatinine|The level of creatinine (as an indicator of kidney function, to approximate GFR) in the serum
15879096|NCT03811847|Drug|Methylphenidate Extended Release Oral Capsule|Stimulant It can treat ADHD and narcolepsy.
15879097|NCT03811847|Other|Placebo|Placebo comparator
15879098|NCT03811834|Drug|Mobocertinib|Mobocertinib capsule, [14C]-Mobocertinib intravenous infusion, [14C]-Mobocertinib oral solution.
15879099|NCT03811821|Behavioral|Biofeedback|The participant will learn how to improve strength and rectal sensation during five (5) - six (6) visits each lasting 60 minutes.
15879100|NCT03811821|Device|Injection|The participant will have a bulking agent injected into rectal wall to narrow opening. Two visits each lasting 45 minutes at weeks 0 and 6 respectively.
15879101|NCT03811795|Other|ECG monitoring with a Kardia Mobile monitor|The participants in the study will undergo a total of two follow-up visits after ablation (approximately 3 and 6 months) with a 12-lead electrocardiogram at each visit. An assessment of rhythm will be performed with daily transmissions as well as subject-activated event recordings for symptoms with the Kardia Mobile smartphone based monitor. The Kardia Mobile System is an FDA-cleared, clinical grade mobile ECG monitor coupled with a smartphone app that is able to record a single-lead ECG and securely transmit the tracings to the study investigators via the Kardia Pro commercial (HIPPA compliant) remote monitoring service for clinicians.
15879102|NCT03811782|Behavioral|Single-task Training|In each training session, all groups will have warm-up (5 minutes), balance training (5 minutes), body transport training (5 minutes), body transport with hand manipulation training (5 minutes), walking training with various difficulties in a 10 meters walkway with Single-task Training instructions (20 minutes) and cool down (5 minutes).
15879103|NCT03811782|Behavioral|Dual-task Training|In each training session, all groups will have warm-up (5 minutes), balance training (5 minutes), body transport training (5 minutes), body transport with hand manipulation training (5 minutes), walking training with various difficulties in a 10 meters walkway with Dual-task Training instructions (20 minutes) and cool down (5 minutes).
15879104|NCT03811782|Behavioral|Analogy Training|In each training session, all groups will have warm-up (5 minutes), balance training (5 minutes), body transport training (5 minutes), body transport with hand manipulation training (5 minutes), walking training with various difficulties in a 10 meters walkway with Analogy Training instructions (20 minutes) and cool down (5 minutes).
15879105|NCT03811769|Other|Best Medical Therapy|The administration of medications is at the treating physician's discretion (for example intravenous fibrinolysis, anticoagulants or antiplatelet) according to local standards of care but may NOT include any intra-arterial therapies.
15879106|NCT03811769|Procedure|Mechanical Thrombectomy|MT in the Experimental Arm can be performed with any thrombectomy (CE labeled) device usually used at study site. For the subjects randomized to the MT plus BMT arm start of treatment is defined as the date and time of groin puncture (arterial access).
15879107|NCT03811756|Dietary Supplement|Test syrup containing CoQ10 and collagen|Test group will receive investigational product - test syrup (daily dose 10 mL: fish collagen: 4000 mg, water soluble CoQ10 (Q10Vital®): 50 mg, vitamin C: 80 mg, vitamin A: 920 μg, biotin: 150 μg); continuous administration of investigational product for 12 weeks.
15879108|NCT03811756|Dietary Supplement|Placebo syrup|Placebo group will receive placebo syrup without active ingredients. (daily dose 10 mL: fish collagen: 0 mg, water soluble CoQ10 (Q10Vital®): 0 mg, vitamin C: 0 mg, vitamin A: 0 μg, biotin: 0 μg); continous administration of placebo product for 12 weeks.
15879109|NCT03811743|Behavioral|Brenner FIT|Brenner FIT pediatric weight management program enrollment. an interdisciplinary, family-based pediatric weight management clinic based upon the Familial Approach to Treatment of Childhood Obesity. Patients are referred by a physician for obesity or overweight with a weight-related comorbidity. Treatment teams are comprised of a pediatrician, counselor, dietitian, and physical activity specialist, with others (e.g., social workers, physical therapists) as needed. The entire family is encouraged to attend all aspects of the treatment program, although only one attending caregiver is required.
15879110|NCT03811743|Behavioral|By Design|Weight loss program for adults/caregivers of those enrolled in Brenner FIT. Participants in the By Design condition (adult caregivers) will be prescribed the Essentials lifestyle intervention which includes tailored dietary and physical activity goals designed to achieve 1-2 lbs./week of weight loss, provided by a multidisciplinary team of medical providers, dietitians, behaviorists, and exercise specialists. A daily calorie restriction of 500 kcal/day is prescribed based on estimates of total energy expenditure (TEE) obtained from a measured resting metabolic rate (RMR) prior to enrollment.
15879111|NCT03811743|Behavioral|Coordination|"This component adds four additional strategies: dyad group sessions, one-on-one parent/child communication sessions, joint goal setting/tracking, and home environment assessment. This innovative approach will seek to employ components of motivation and communication theories to increase self-monitoring, positive communication, problem solving, and social support to increase healthy physical activity and eating behaviors to increase the effectiveness of the weight loss programs beyond gains observed in matched controls.
~Essentials (adults), with four additional components: dyad group sessions, one-on-one parent/child communication sessions, joint goal setting/tracking, and home environment assessment"
15879114|NCT03811717|Other|FAST|Participants will complete an 8-hour fast.
15889978|NCT03727464|Drug|Propofol|Propofol general anesthesia
15879116|NCT03811704|Drug|Indocyanine Green|ICG was administered 24 hours before the operation or intravenously after clamping the Glissonian sheaths flowing in the cancer-bearing hepatic segment, or directly into the portal branches supplying blood flow to the tumor-bearing hepatic segment, after puncturing of the target segments under intraoperative ultrasonography guidance.
15879117|NCT03811691|Diagnostic Test|MRI exam|Pacing system safety and stability under MRI scan environment
15879118|NCT03811678|Drug|Kangdaprevir Sodium Tablet|Tablet，administered orally once daily
15879119|NCT03811678|Drug|placebo|Tablet，administered orally once daily
15879120|NCT03811665|Procedure|Radiofrequency Ablation|RFA probe will create an ablation zone of a 1.0 cm diameter beyond the maximum CT-measured tumor diameter. The generator will modulate power up to 150 W in reach average ablative temperature of 105oC. Tumors will be treated for two cycles of 8 minutes duration each upon reaching target temperatures.
15879121|NCT03811665|Radiation|Stereotactive body radiation therapy|The Gross Tumour Volume (GTV) is defined as the visible tumour seen on the planning CT simulation. No clinical target volume (CTV) for microscopic disease is necessary. The internal target volume (ITV) accounts for changes in tumour position due to respiration, and is assessed on 4DCT. The planning target volume (PTV) will be a standard 0.5 cm around the ITV.
15879122|NCT03811652|Drug|MEDI7247|Subjects with advanced solid tumors will enroll into the respective arms to receive Medi7247 IV at prescribed dose and schedule
15879123|NCT03811639|Procedure|Radio-frequency ablation|Ablation for atrial fibrillation
15879124|NCT03811639|Procedure|Cryoballoon ablation|Ablation for atrial fibrillation
15879125|NCT03811626|Procedure|cognitive-behavioral rehabilitation|Combination of clinical examination and neuropsychological and psychological tests
15879126|NCT03811613|Other|Transcranial photobiomodulation|Photobiomodulation was administered using red light-emitting diodes (LEDs) with a 670-nm wavelength (which has proven to penetrate the skull)
15879127|NCT03811600|Diagnostic Test|PD1/PD-L1 exosomal expression|exosomal PD1/PD-L1 expression
15879128|NCT03811587|Other|Fasting Mimicking diet|The fasting mimicking diet is though to activate the metabolism as fasting would do, although the diet does include several meals a day and more calories than conventional fasting diets.
15879129|NCT03811574|Drug|Semaglutide|Semaglutide injections will be administered once-weekly by a pre-filled pen-injector at the same day of the week (to the extent possible). Injections may be administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals.
15879130|NCT03811574|Drug|Placebo (semaglutide)|Placebo (semaglutide) injections will be administered once-weekly by a pre-filled pen-injector at the same day of the week (to the extent possible). Injections may be administered in the thigh, abdomen or upper arm, at any time of day irrespective of meals.
15879133|NCT03811548|Drug|Janagliflozin 25mg|Tablets, Oral, 25 mg, Tablets, Oral, 50 mg
15879134|NCT03811548|Drug|Janagliflozin 50mg|Tablets, Oral, 25 mg, Once daily, 52 weeks
15879135|NCT03811548|Drug|Placebo/Janagliflozin|Tablets, Oral, 25 mg, Once daily, 52 weeks
15879136|NCT03811535|Drug|Somapacitan|Somapacitan will be administered subcutaneously (s.c.; under the skin) once weekly by PDS290 pen-injector. Somapacitan can be injected any time during the once weekly dosing day. The dose will be calculated based on the subject's current body weight.
15879137|NCT03811535|Drug|Norditropin®|Norditropin® will be administered s.c. once daily by FlexPro® pen-injector. Norditropin® should be injected daily in the evening. The dose will be calculated based on the subject's current body weight.
15879138|NCT03811522|Other|carbon dioxide insufflation|Receives CO2 insufflation
15879139|NCT03811522|Other|Air insufflation|Receives air insufflation
15879140|NCT03811509|Drug|bisphosphonate|antiresorptives
15879141|NCT03811470|Other|Standard diabetes management model in each MMC center|Standard diabetes management model in each MMC center
15879142|NCT03811457|Genetic|Welgenaleucel|Welgenaleucel (UWC19) is a CD19-directed immunotherapy consisting of autologous T cells, which is reprogrammed to target cells that express CD19.
15879143|NCT03811444|Device|Haemolance Plus safety lancet|Haemolance Plus safety lancet type 420 is a sterile, single use medical device designed for the sampling of capillary blood from the fingertip of patients
15879144|NCT03811444|Device|Prolance safety lancet|Prolance safety lancet type 430 is a sterile, single use medical device designed for the sampling of capillary blood from the fingertip of patients.
15879145|NCT03811444|Device|MediSafe Solo safety lancet|MediSafe Solo safety lancet type 520 is a sterile, single use medical device designed for the sampling of capillary blood from the fingertip of patients.
15879146|NCT03811431|Procedure|Contrast enhanced ultrasound guided liver biopsy|Conventional liver biopsy
15879147|NCT03811418|Drug|Trastuzumab|"administered as combined therapy with pertuzumab and vinorelbine or docetaxel.
~Trastuzumab will be administered as an IV loading dose of 8 milligrams per kilogram (mg/kg) on day 1 of cycle 1 (1 cycle length = 21 days), and 6 mg/kg Q3W on day 1 of subsequent cycles until progressive disease, intolerable toxicity, or death."
15879148|NCT03811418|Drug|Pertuzumab|"administered as combined therapy with Kanjinti® and vinorelbine or docetaxel.
~Pertuzumab will be administered as an IV loading dose of 840 milligrams (mg) on day 1 of cycle 1 (1 cycle length = 21 days), and 420 mg Q3W on day 1 of subsequent cycles until progressive disease, intolerable toxicity, or death."
15879261|NCT03810482|Device|Pedometer|A pedometer will be worn by the patient at home for days 1 to 14 and 60 to 74.
15879149|NCT03811418|Drug|Vinorelbine|"administered as combined therapy with Kanjinti® and pertuzumab.
~Vinorelbine will be administered as an IV dose of 25 milligrams per kilogram (mg/kg) on days 1 and 8 of cycle 1 (1 cycle length = 21 days), and 25mg/kg up to 30 mg/kg (as per treating physician discretion) Q3W on day 1 of subsequent cycles until progressive disease, intolerable toxicity, or death."
15879150|NCT03811418|Drug|Docetaxel|"administered as combined therapy with Kanjinti® and pertuzumab.
~Docetaxel will be administered as an IV dose of 75 milligrams per square meter (mg/m^2) on day 1 of cycle 1 (1 cycle length = 21 days), and 75 mg/m^2 (up to 100 mg/m^2 as per treating physician discretion) Q3W on day 1 of subsequent cycles until progressive disease, intolerable toxicity, or death."
15879151|NCT03811405|Device|Active biphasic pulse stimulation---Home Settings|During this visit, the DBS implantable pulse generator (IPG) will be loaded with a temporary custom firmware to allow implementation of active biphasic pulse stimulation.
15879152|NCT03811405|Device|Active biphasic pulse stimulation---VIN Biphasic|During this visit, the DBS implantable pulse generator (IPG) will be loaded with a temporary custom firmware to allow implementation of active biphasic pulse stimulation.
15879153|NCT03811405|Device|Active biphasic pulse stimulation---Stimulator Off|During this visit, the DBS implantable pulse generator (IPG) will be loaded with a temporary custom firmware to allow implementation of active biphasic pulse stimulation.
15879154|NCT03811392|Procedure|Hernioraphy/Caudal block|30 patients will receive a caudal block after induction of general anaesthesia
15879155|NCT03811392|Procedure|Hernioraphy/Quadratus Lumborum block|30 patients will receive ultrasound guided quadrates lumborum block
15879156|NCT03811379|Drug|Toripalimab|Drug: Toripalimab, 240mg, every 3 weeks until disease progress or intolerable toxicity
15879157|NCT03811366|Drug|Meticorten|All patients were treated with 3-day methylprednisolone pulse therapy followed by 1mg/day oral prednisone with slow tapper over a median 13 months
15879158|NCT03811353|Diagnostic Test|T-MOE|Chewing performance will be evaluated with T-MOE and the Karaduman Chewing Performance Scale.
15879159|NCT03811327|Behavioral|Zero-time Exercise|A 2-hour group ZTEx training once per week for 2 consecutive weeks (totally 4 hours)
15879160|NCT03811314|Device|Strength training|Using dumbbells, butterfly machine and vertical leg press machine for strength training, 12 repetition maximum weight for 12 repetition, three times a day, five days a week, for a total of four weeks
15879161|NCT03811314|Device|Aerobic training|Using stationary bicycle to perform cardiopulmonary endurance training in 50-70 heart rate reserve for 20 minutes, five days per week, for a total of four weeks
15879162|NCT03811301|Device|BrainConnexion|A 4.4mm by 4.2mm electrode array is placed onto the surface of the motor cortex which is then connected to a miniaturized neural recording microsystem that transmits signals wirelessly to control an external assistive device. Neural signals are recorded at least once every week for 12 months or longer.
15879163|NCT03811288|Other|No treatment given|No specific intervention is studied. All anti-diabetic and CV medication will be prescribed at the physician's discretion under routine clinical practice conditions.
15879164|NCT03811275|Behavioral|Virtual Reality (A) then Task (B)|Participants will use their intact arm to perform virtual reality tasks while perceiving a reflected virtual image of their paretic arm.
15879165|NCT03811275|Behavioral|Task (B) then Virtual Reality (A)|Participants will use their paretic arm to perform real tasks in a structured environment, with a practice and feedback schedule organized by a physical or occupational therapist, or graduate student.
15879166|NCT03811262|Procedure|ESP BLOCK|local anesthetic will be injected between transverous process and erector spinae muscle
15879167|NCT03811262|Procedure|PECS BLOCK|local anesthetic will be injected between pectoralis minor and pectoralis major (10 ml) and between pectoralis minor and serratus (20 ml)
15879168|NCT03811249|Device|VisAbility™ Micro Insert|No (new) intervention will be administered during the course of this long term follow-up study. Subjects that previously participated in the VIS-2014 clinical trial that had VisAbility™ Micro Inserts surgically implanted in the eye(s) will be followed prospectively.
15879169|NCT03811236|Other|Cold exposure|Two hours of mild cold exposure using a water-perfused vest
15879170|NCT03811223|Drug|Evolocumab Auto-Injector [Repatha]|Evolocumab 140 mg every 2 weeks for 12 weeks
15879171|NCT03811223|Drug|Placebos|Placebo subcutaneous injection every 2 weeks for 12 weeks
15879172|NCT03811210|Behavioral|portion size|"Smaller than normal portion size - the intervention is the main meal component size perceived as 'smaller than normal' that participants are provided with during lunch and dinner in the laboratory.
~Small-normal portion size - the intervention is the main meal component size perceived as 'small-normal' that participants are provided with during lunch and dinner in the laboratory.
~Large-normal portion size - the intervention is the main meal component size perceived as 'large-normal' that participants are provided with during lunch and dinner in the laboratory."
15879173|NCT03811197|Behavioral|Dietary counseling via face to face meeting|All subjects received individual MNT and individual dietary recommendations based on DASH (Dietary Approaches to Stop Hypertension) diet plan for 6 months (Part A). Dietary counseling is provided by a trained dietitian. Months 9 and 12 - follow up (Part B).
15879174|NCT03811197|Behavioral|Telemedicine|All subjects received an additional dietary counseling for 6 months (via internet, messenger or telephone) two weeks after each standard visit will be added to the counseling (Part A). Standard and additional dietary counseling (T) are provided by a trained dietitian. Months 9 and 12 - follow up (Part B).
15879175|NCT03811197|Behavioral|Hypnotic Suggestions|"All subjects received individual hypnotic suggestion (HS) for 6 months as a supplementary method for dietary counseling. HS will be adapted to the small steps method used in the management of obesity. During the visit, HS will be recorded and the individual will listen to it every day (Part A). HS will be provided by a physician, qualified in the field of hypnotherapy. Months 9 and 12 - follow up (Part B)."
15879176|NCT03811184|Diagnostic Test|MemScreen|Neuropsychological test on smartphone or digital tablet, on self assesment.
15879177|NCT03811171|Device|Break Wave extracorporeal lithotripsy|The Break Wave device will be used to exert a low amplitude burst of ultrasound waves focused at the kidney stone. The primary components of the device include an 85 mm aperture diameter therapy probe driven by a high voltage generator. The therapy probe has a cavity in the middle to accommodate coaxial alignment of an ultrasound imaging probe for treatment guidance.
15879447|NCT03809130|Other|Questionnaire Administration|Ancillary studies
15879178|NCT03811158|Device|HHHFNC|Prospective, randomized crossover control trial, single ICU. Patents with COPD exacerbation who were intubated for respiratory failure will all enrolled to this study. Participants will be studied on 2 consecutive days and random assigned with crossover.
15879179|NCT03811158|Device|UHFOM|Prospective, randomized crossover control trial, single ICU. Patents with COPD exacerbation who were intubated for respiratory failure will all enrolled to this study. Participants will be studied on 2 consecutive days and random assigned with crossover.
15879180|NCT03811145|Biological|Tendoncel|Platelet lysate gel
15879181|NCT03811145|Other|Placebo control gel|Placebo control gel
15879182|NCT03811119|Device|MANTA vascular closure device|Collagen based vascular closure device
15879183|NCT03811119|Device|Suture based vascular closure device|Suture based vascular closure device (ProGlide)
15879184|NCT03811106|Device|NeuromuscularElectricalStimulation+ConventionalPhysiotherapy|Sırt ekstansör kaslarına nöromusküler elektrik stimülasyonu uygulanacaktır
15879185|NCT03811106|Other|Conventional physiotherapy and rehabilitation|Konvansiyonel fizyoterapi ve rehabilitasyon uygulamaları yapılacaktır.
15879186|NCT03811093|Device|Care as Usual Group|"Each participant randomly assigned to the Care As Usual Group will undergo nine therapy sessions over three weeks using a fully functioning invisa-RED Technology Elite device."
15879187|NCT03811093|Device|Sham Group|"Each participant randomly assigned to the Sham Group will undergo nine therapy sessions over three weeks using a non functioning invisa-RED Technology Elite device."
15879188|NCT03811080|Drug|DWP14012 A mg|The participants will receive treatment of DWP14012 A mg, tablet, orally, once daily and DWP14012 B mg placebo-matching tablet, orally, once daily for up to 4 weeks.
15879189|NCT03811080|Drug|DWP14012 B mg|The participants will receive treatment of DWP14012 B mg, tablet, orally, once daily and DWP14012 A mg placebo-matching tablet, orally, once daily for up to 4 weeks.
15879190|NCT03811080|Drug|Placebo|The participants will receive treatment of DWP14012 A mg placebo-matching tablet, orally, once daily and DWP14012 B mg placebo-matching tablet, orally, once daily for up to 4 weeks.
15879191|NCT03811067|Procedure|Transversus abdominis plane block|Transversus abdominis plane block will be performed bilaterally after the surgery.
15879192|NCT03811067|Procedure|Rectus sheath block|Rectus sheath block will be performed bilaterally after the surgery.
15879193|NCT03811054|Drug|Apatinib（250mg/d） combined with EGFR-TKI|Patients with advanced non-small cell lung cancer (NSCLC) who had treated with EGFR-TKI and progressed slowly because of resistance are underwent with apatinib mesylate and continuous EGFR-TKI.
15879194|NCT03811041|Other|MDA|Depressed adolescents of depressed parents will be oriented to the MDA of Brest for depression cares.
15879195|NCT03811041|Other|Routine Cares|Depressed adolescents of depressed parents will be oriented to routine cares for depression cares.
15879196|NCT03811041|Other|Parental depression|Parents of depressed adolescents will be met for a screening test of depression.
15879197|NCT03811028|Drug|SOBI003|weekly i.v. infusion
15879210|NCT03810989|Device|infra-red sauna|During the intervention phase, the ESRD patients twill be subjected to a method of stimulation of sweating as the following :- three session of infra-red sauna of 15 minutes duration separated by ten minutes rest outside the sauna.
15879211|NCT03810989|Device|argometer and treadmill|During the intervention phase, the ESRD patients twill be subjected to a method of stimulation of sweating as the following :- three session of physical exercise (by treadmill and argometer) of 20-30 minutes duration separated by 10 minutes rest.
15879212|NCT03810989|Device|combination of sauna and hot bath|During the intervention phase, the ESRD patients twill be subjected to a method of stimulation of sweating as the following :- three session of infra-red sauna as the first group then the patients will be immersed up to neck for one hour in water at 37-43 C.
15879213|NCT03810976|Drug|Eribulin, gemcitabine|Elibulin 1.4mg/m2 Intravenous for 5minutes. Day 1& Day 8 every 3 weeks Gemcitabine 1000mg/m2 intraveoust for 30 minutes, Day 1& Day 8 every 3 weeks
15879214|NCT03810963|Combination Product|HIIT-FES Cycling combined with Nutritional Counseling|High intensity interval training functional electrical stimulation cycling for 30 minutes, three days per week for eight weeks, Nutritional counseling over the telephone for 30 minutes once per week for eight weeks.
15879215|NCT03810963|Other|Nutritional Counseling Only|Nutritional counseling over the telephone for 30 minutes once per week for eight weeks.
15879216|NCT03810950|Behavioral|Trier Social Stress Test|Test to induce high levels of acute social stress, including actors and a faked exam situation
15879217|NCT03810950|Behavioral|Reading Newspaper|Participants read newspaper
15879218|NCT03810950|Behavioral|Barlab-Exposure|Participants are exposed to a bar situation with different sorts of alcohol available. They sniff at water and at one alcoholic drink.
15879219|NCT03810937|Other|head position|head positioning in sniffing or flat position
15879220|NCT03810924|Behavioral|Trier Social Stress Test|Test to induce high levels of acute social stress, including actors and a faked exam situation
15879221|NCT03810924|Behavioral|Ergometer|Riding ergometer
15879222|NCT03810924|Behavioral|Barlab-Exposure|Participants are exposed to a bar situation with different sorts of alcohol available. They sniff at water and at one alcoholic drink.
15879223|NCT03810924|Behavioral|Reading Newspaper|Participants read newspaper
15879224|NCT03810911|Drug|Darbepoetin|Used to treat anemia. In the group labeled no intervention, the intervention is simply delayed 12 weeks after randomization as noted in the description.
15879225|NCT03810898|Radiation|Radioligand [¹¹C]CHDI-00485180-R|Intravenous injection of radioligand in the arm with PET imaging of the brain.
15879226|NCT03810898|Radiation|Radioligand [¹¹C]CHDI-00485626|Intravenous injection of radioligand in the arm with PET imaging of the brain.
15879227|NCT03810885|Other|Bread with reduced salt content|Bread with gradually lowered salt content
15879228|NCT03810885|Behavioral|Dietary advice|Participants will receive information on how to lower salt and increase potassium intake
15879229|NCT03810885|Other|Bread with standard salt content|Bread with normal salt content
15879230|NCT03810872|Drug|Afatinib|Open label
15879231|NCT03810872|Drug|Paclitaxel|Paclitaxel
15879232|NCT03810859|Biological|Blood sample|Adults : 7 to 10 mL Childs : 2 to 4 mL
15879233|NCT03810846|Behavioral|Walking football exercise program|Participants will be organized in two teams of 20 players. Each team will have 60-min walking football exercise sessions three times per week (non-consecutive days), during three months (36 sessions). Different walking football exercise strategies will be developed according to participants' motor skills and tested with dose-escalated intensity for its safety and enjoyment. Exercise intensity will range between light to vigorous. No submaximal or maximal exercises will be tested. Exercise sessions will be conducted on a sports hall (indoor court) by a football coach and supervised by an exercise physiologist and a nurse.
15879234|NCT03810833|Device|Brilliance device sensor|Two separate sensors will be attached via standard, single-use adhesive pads to the left and right pectoralis major on each participant.
15879235|NCT03810820|Device|mobile Cardiac Arrhythmia Diagnostics Service (m-CARDS)|A wearable cardiac monitoring device is provided to patients pre- and post-TAVI. The monitor transmits cardiac data in real time to the m-CARDs team. Cardiac abnormalities are reported to the clinical team who then assess the abnormality and intervene as clinically necessary.
15879236|NCT03810807|Drug|Dacomitinib|Dose level 1 Dacomitinib, Dose level 2 Dacomitinib, Dose level 3 Dacomitinib. Three patients will need to be enrolled at each dose level and assessed for DLT for 1 full cycle (28 days for cycle 1) before dose escalation decision is made.
15879237|NCT03810807|Drug|Osimertinib|Dose level 1, 2 and 3 Osimertinib 40mg daily. Three patients will need to be enrolled at each dose level and assessed for DLT for 1 full cycle (28 days for cycle 1) before dose escalation decision is made.
15879238|NCT03810794|Other|Acupuncture|The main acupoints are DU 24, EX-HN 3, DU 20, EX-HN 1, GB 12, HT 7, KI 6, GB39, and then selecting other acupoints according to TCM syndrome. The electric stimulator will be applied to DU 24, GB 12, HT 7, and LR 3 or SP 6 with a disperse-dense wave of 2/50 Hz, 0.5-1.0 mA. There are three sessions per week with each session lasting for 30 min. There will be 12 weeks of treatment for each participant in total.
15879239|NCT03810794|Drug|Donepezil|Donepezil 5 mg will be given once daily before bed-time for 12 weeks. After the clinical trial, participants will be given conventional treatment clinically.
15879240|NCT03810755|Other|Personalized Supervised physical activity|personalized exercise program for patients, supervised during 3 months by nursing in primary and autonomous care afterwards, with support from community resources
15879241|NCT03810742|Drug|Nanoliposomal Irinotecan|Nanoliposomal Irinotecan (nal-IRI, ONIVYDE®) in Combination with TAS-102 (LONSURF®)
15879242|NCT03810729|Diagnostic Test|Smartphone assessment|The smartphone app will be performed on participants randomly assigned to receive this test.
15879243|NCT03810729|Diagnostic Test|Modified Allen's Test|The modified Allen's test will be will be performed on participants randomly assigned to receive this test.
15879244|NCT03810716|Device|Interactive Platform|The participants will see the interactive platform.
15879245|NCT03810703|Drug|Placebo oral capsule|Placebo oral capsule
15879246|NCT03810703|Drug|d-amphetamine 10 mg oral capsule|d-amphetamine 10 mg oral capsule
15879247|NCT03810703|Drug|d-amphetamine 20 mg oral capsule|d-amphetamine 20 mg oral capsule
15879248|NCT03810690|Biological|mRNA-3704|mRNA-3704 dispersion for intravenous (IV) infusion
15879249|NCT03810677|Device|ELVeS® Radial® 2ring slim fiber|Device for endovenous laser ablation manufactured by Biolitec AG company (ELVeS system) - diode laser with a wavelength of 1470 nm
15879250|NCT03810664|Drug|Somatrogon|A single dose of 12 mg of somatrogon will be injected as one sc injection to the arm on each dosing day (Day 0 and Day 14).
15879251|NCT03810651|Other|Proton beam radiation using pencil beam scanning|Proton beam radiation using pencil beam scanning, characterized by Bragg peak dose deposition and high conformality of dose to target regions
15879252|NCT03810625|Drug|D-0502|D-0502 oral tablets
15879253|NCT03810599|Other|Early cardiac rehabilitation|"This is an early cardiac rehabilitation programme starting 1-2 weeks after hospital discharge (Phase 2A rehabilitation). The programme provided by a multidisciplinary team includes individual counseling, educational sessions and discussion in groups, and exercise training sessions three days a week for five weeks.
~For additional analysis there will be a comparison group that did not receive the intervention for practical reasons."
15879254|NCT03810586|Device|Non-invasive measurement of blood pressure|Comparing non-invasive measurement of blood pressure using the PPG-based BB-613 device to a blood pressure manomtry holter device (HUGECARE NIBP Monitor)
15879255|NCT03810573|Device|NB1|rhNELL-1/DBX
15879256|NCT03810560|Device|laser device Er,Cr:YSGG laser|laser device with open flap debridement
15879257|NCT03810547|Drug|Propofol 10 Mg/mL Intravenous Emulsion|when spinal anesthesia is not satisfactory intervention drugs are used
15879258|NCT03810534|Behavioral|Connect-Home|Connect-Home will introduce organizational structure to support delivery of transitional care processes. New elements of structure include:electronic health record (EHR) template, Connect-Home Toolkit, and Staff Training. After structural elements are added, SNF staff will use Connect-Home care processes to deliver the 2-step transitional care intervention.In Step 1, SNF nurses, therapists, and social workers will develop a Transition Plan of Care and prepare the patient and caregiver to manage the patient's serious illness and functional needs. In Step 2, the Connect-Home Activation RN will visit the patient's home within 24 hours of discharge; the nurse will activate the Transition Plan of Care at home. Both intervention steps focus on 6 key care needs to optimize patient and caregiver outcomes: 1) home safety and level of assistance; 2) advance care planning; 3) symptom management; 4) medication reconciliation; 5) function and activity; and 6) coordination of follow-up medical care.
15879259|NCT03810521|Biological|umbilical cord derived-mesenchymal stromal cells|Intra-articular infiltration of umbilical cord derived-mesenchymal stromal cells
15879262|NCT03810482|Other|6 minute walking test|Performed according to current recommendations during routine visits (baseline and ~90 days for the purposes of this study).
15879263|NCT03810456|Behavioral|Intensive Cognitive Behavior Therapy (iCBT)|Participants randomized to iCBT will receive 16 hours of cognitive behavioral therapy for anxiety over one weekend. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.
15879264|NCT03810456|Behavioral|Standard Cognitive Behavior Therapy (sCBT)|Participants randomized to sCBT will receive 16 hours of cognitive behavioral therapy for anxiety weekly over a period of 12 weeks. The treatment entails psychoeducation, cognitive restructuring and exposure exercises.
15879265|NCT03810443|Diagnostic Test|Hyperventilation test|The elements of the research consist of the Nijmegen questionnaire response, two dyspnea questionnaires (Dyspnea 12, MDP), a quality of life questionnaire (SF36), a psychological disorder screening questionnaire (HAD) and a diagnostic test: the hyperventilation test.
15879266|NCT03810430|Behavioral|health promotion|health promotion on water, sanitation and hygiene and child feeding along with hygiene kits were delivered to the mothers in the intervention arm
15879269|NCT03810404|Dietary Supplement|Sodium bicarbonate supplementation|"Interventions:
~The experimental procedure for each athlete included an acute SB supplementation in a different-dose regimen in order to assess whether the dose affects the actual physical and exercise capacity (doses: 0,15-, 0,25- and 0,35 g/kgFFM, respectively). SB (Alkala T, SANUM, Poland) will be administered as dissolved form in a 600 ml of fluid (water + fruit juice). On testing days the supplements will be taken 2 hours before physical and exercise capacity tests session.
~Between the SB and PLA or a PLA and SB treatments, a minimum 7-day washout period will be introduced."
15879270|NCT03810404|Dietary Supplement|Placebo treatment|"Interventions:
~The experimental procedure for each athlete will be included an PLA supplementation. Placebo will be administered in a form of 600 ml of fluid (water + fruit juice). On testing days the PLA will be taken 2 hours before physical and exercise capacity tests session.
~Between the PLA and SB or a SB and PLA treatments, a minimum 7-day washout period will be introduced."
15879271|NCT03810391|Drug|Butorphanol|intravenous loading dose of 15ug/kg butorphanol,and followed by infusion of 7.5ug/kg/h butorphanol and stopped infusion until the Ramsay sedation score reached 4 points
15879272|NCT03810391|Other|physiological saline|intravenous infusion of the same volume of physiological saline
15879273|NCT03810378|Behavioral|Mediterranean Diet (Med-Plus)|Participants will follow the Med-Plus diet for 12 weeks, then switch to the alternate diet for another 12 weeks (no washout period).
15879274|NCT03810378|Behavioral|Well-Formulated Ketogenic Diet (WFKD)|Participants will follow the WFKD diet for 12 weeks, then switch to the alternate diet for another 12 weeks (no washout period).
15879275|NCT03810365|Behavioral|Brief behavioral treatment for insomnia|Healthy eating control involves healthy eating content with 1 month 3 month 12 month follow-up visits.
15879276|NCT03810339|Drug|Toripalimab|Toripalimab, 240mg, every 3 weeks until disease progress or intolerable toxicity
15879277|NCT03810326|Device|CTR device (tradename named Xtend)|Non invasive active splint
15879278|NCT03810313|Drug|Brolucizumab 6 mg|Solution for injection (intravitreal use)
15879279|NCT03810313|Drug|Aflibercept 2 mg|Solution for injection (Intravitreal use)
15879280|NCT03810313|Other|Sham injection|Empty sterile syringe without a needle administered as a sham injection for masking
15879281|NCT03810300|Other|Cash transfer|1500 taka ($18.75) per household distributed monthly
15879282|NCT03810300|Other|Food transfer|30 kg rice, 2 kg lentils, and 2 kg micro-nutrient fortified cooking oil per household distributed monthly
15879283|NCT03810300|Other|Food and cash transfer|15 kg of rice, 1 kg of lentils, and 1 kg of micronutrient-fortified cooking oil, and 750 taka cash per household, distributed monthly
15879284|NCT03810300|Behavioral|Nutrition behavior Communication Change (BCC)|Weekly, group-based, one-hour meetings on maternal and child nutrition, sanitation and health knowledge, attitudes and practice; twice-a-month home visits; monthly community meetings
15879285|NCT03810300|Other|Control|No transfer, no behavior change communication
15879286|NCT03810287|Drug|Domperidone|Domperidone will be prescribed for patients with upper GI symptoms at an initial dose of 10 mg up to 4 times a day (prior to each meal and at bedtime). It is possible that the dose of domperidone may be increased to 20 mg if symptoms are not adequately controlled on the initial dose.
15879287|NCT03810274|Device|3DV+TPS；VARIAN TPS；FonicsPlan|
15879288|NCT03810261|Dietary Supplement|Oil-based vitamin D|Participants will receive oil-based VALENS vitamin D, 1000 IU/day for 8 weeks.
15879289|NCT03810261|Dietary Supplement|Water-based vitamin D|Participants will receive water-based VALENS vitamin D, 1000 IU/day for 8 weeks.
15879290|NCT03810261|Dietary Supplement|Vitamin D capsules|Participants will receive vitamin D capsules with starch-adsorbed vitamin D (powder), 1000 IU/day for 8 weeks.
15879291|NCT03810235|Drug|Transdermal Lidocaine Patch|Transdermal Lidocaine Patch
15879292|NCT03810235|Drug|Transdermal Hydrocolloid Placebo Patch|hydrocolloid placebo patches
15879293|NCT03810222|Other|N/A (Observational Study)|This is an observational study and does not include interventions. Exposure is TBI.
15879294|NCT03810209|Drug|Magnesium Sulphate|adding magnesium sulphate to local anaesthetic in SAP Block
15879295|NCT03810209|Drug|Normal saline|adding normal saline to local anaesthetic in SAP block
15879296|NCT03810196|Device|CliniMACS Cell Processing System for TCRαβ + T Cell and CD45RA Depleted Peripheral Stem Cell Addback|Peripheral stem cell (PSC) product will be processed using the CliniMACS device for TCRαβ and T cell depletion. Approximately 10% of the PSCs will undergo CD45RA depletion and cryopreservation. Patients will receive CD45RA depleted infusion after the TCRab PSCT.
15879297|NCT03810183|Drug|QAW039|QAW039 (fevipiprant) 450 mg once daily for 6 weeks administered orally as a tablet + Standard of Care
15879298|NCT03810183|Drug|Placebo|Placebo once daily for 6 weeks administered orally as a tablet + Standard of Care
15879299|NCT03810170|Behavioral|safe sex and HIV/STD prevention education via a website|website providing positive psychology-based advice and education for women over the age of 50 who are divorced. embedded in site is safe sex education.
15879483|NCT03808870|Drug|NBM-BMX softgel capsules|Patients will initially receive NBM-BMX orally once a day at 100 mg per day.
15879300|NCT03810170|Other|written materials on safe sex|2 page written materials on safe sex and HIV/STD prevention education, as well as weekly emails on general women's health topics
15879301|NCT03810157|Device|Laser-assisted hatching system|The ZP was thinned or drilled with the Laser-assisted hatching system. The laser pulse was 0.296 ms. Laser aperture was 8μm.
15879302|NCT03810144|Genetic|Vectra DA MBDA Test|Vectra Guided versus Usual Care
15879303|NCT03810131|Other|'A Bite of ACT' (BOA)|An online Acceptance and Commitment Therapy transdiagnostic psychoeducational intervention called 'A Bite of ACT' (BOA)
15879304|NCT03810118|Diagnostic Test|fluid challenge|4 ml/kg fluid challenge infused over in either 10 or 20 minutes
15879305|NCT03810105|Drug|Olaparib|Olaparib 300mg twice daily (600mg total daily dose)
15879306|NCT03810105|Drug|Durvalumab|Durvalumab 1500mg IV monthly
15879307|NCT03810079|Device|Anodal transcranial direct current stimulation|Neuromodulation of bilateral prefrontal areas using 2 mA tDCS delivered during 20 minutes via sponge electrodes on the scalp
15879308|NCT03810079|Device|Sham transcranial direct current stimulation|Identical to anodal tDCS, except that the stimulation is stopped after 15 seconds.
15879309|NCT03810066|Drug|Osimertinib|All patients will be treated with osimertinib 80 mg/d for one cycle (28 days).
15879311|NCT03810040|Device|140 microns denuding pipette|the degranulated needle size was 140 microns
15879312|NCT03810040|Device|150 microns denuding pipette|the degranulated needle size was 150 microns
15879313|NCT03810027|Diagnostic Test|Bladder diary|3-day bladder diary
15879314|NCT03810014|Other|Conditional ACT subsidy, Arm 1 levels|The subsidy levels for participants randomly assigned to Arm 1 are: No subsidy for RDT (price to consumer=$0.40); 100% ACT subsidy (price to consumer=0).
15879315|NCT03810014|Other|Conditional ACT subsidy, Arm 2 levels|The subsidy levels for participants randomly assigned to Arm 2 are: No subsidy for RDT (price to consumer=$0.40); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age).
15879316|NCT03810014|Other|Conditional ACT subsidy, Arm 3 levels|The subsidy levels for participants randomly assigned to Arm 3 are: 50% subsidy for RDT (price to consumer=$0.20); 100% ACT subsidy (price to consumer=0).
15879317|NCT03810014|Other|Conditional ACT subsidy, Arm 4 levels|The subsidy levels for participants randomly assigned to Arm 4 are: 50% subsidy for RDT (price to consumer=$0.20); 67% ACT subsidy (price to consumer=$0.10-0.40, dependent upon patient age)
15879318|NCT03810001|Behavioral|Mechanical Stimulation|micromanipulation technique before insertion of the microinjection needle into the oocyte and expulsion of the spermatozoon
15879319|NCT03809988|Drug|Palbociclib|Palbociclib capsules orally once daily (QD) (at 100mg or 125mg depending on previous treatment dose) for 21 days every four weeks
15879320|NCT03809988|Drug|Endocrine therapy|Endocrine therapy alone (letrozole or fulvestrant)
15879321|NCT03809975|Other|Multidisciplinary Community Program|"Patient will undergoes 12 weeks of structured and personalized multidisciplinary community-based program, which consists of Physiotherapy, Dietetics and Psychology sessions. Patients will also attend 2 educational sessions. Physiotherapy and educational sessions are mandatory for all participants, while the need for dietetics and psychological interventions are determine using individual's BMI measurements and psychological questionnaires.
~Inclusion criteria:
~Dietetics: 23.5 < BMI <32.5; Psychology: PEG > 4 or PHQ-4 > 5 or PAM level < 3"
15879322|NCT03809975|Other|Current model of care|No controlled set of treatment assigned to patient. It is based totally on the discretion of the attending clinicians. It will generally contain an unspecific number of physiotherapy sessions. Other allied health involvement such as dietetics and psychological interventions will be on an ad hoc basis. In some cases, the orthopaedic surgeon may recommend for surgery.
15879323|NCT03809962|Device|Ostenil® Plus|Ostenil® Plus is a CE-certified viscoelastic solution for injection into the Joint cavity, containing 2.0 % Sodium hyaluronate from fermentation
15879324|NCT03809949|Drug|Fentanyl Opioid anesthesia|To compare between opioid and opioid free anaesthesia on post-operative nausea and vomiting in middle ear surgery
15879325|NCT03809949|Drug|Saline Nonopioid anesthesia|To compare between opioid and opioid free anaesthesia on post-operative nausea and vomiting in middle ear surgery
15879326|NCT03809936|Device|real tDCS|Direct current was applied by a battery-driven constant current stimulator using saline-soaked surface sponge electrodes (7 3 5 cm) with the anode positioned over the left dorsolateral prefrontal cortex (F3 according to the 10-20 international system for EEG placement) and the cathode placed over the right supraorbital region. During real tDCS, the current was increased to 2 mA from the onset of stimulation and applied for 20 minutes.
15879327|NCT03809936|Device|sham tDCS|For the sham condition(sham tDCS), the same electrode placement was used as in the stimulation condition, but the current was applied for only 5 seconds, and was then ramped down.
15879328|NCT03809923|Drug|lidocaine and dexmedetomidine infusion|Patients received IV bolus infusion of lidocaine (2%) 1.5 mg/kg and dexmedetomidine 0.5 µg/kg diluted with normal saline to 20 ml in the LD group respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion at rate of lidocaine 1.5 mg/kg and dexmedetomidine 0.4 µg/kg made up to 20 mL every hour until 30 min before the end of operation, respectively.
15879329|NCT03809923|Drug|Saline infusion|Patients received 20 ml normal saline and 20 ml normal saline in the CON group respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion 20 ml normal saline and 20 ml normal saline every hour until 30 min before the end of surgery
15879330|NCT03809923|Drug|Lidocaine infusion|patients received an IV bolus infusion of lidocaine (2%) 1.5 mg/kg made to 20ml with normal saline and 20ml normal saline respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion of lidocaine 1.5 mg/kg made up to 20ml and 20ml normal saline every hour until 30 min before the end of operation, respectively.
15879331|NCT03809923|Drug|Dexmedetomidine infusion|Patients received IV bolus infusion of dexmedetomidine 0.5 μg/kg made to 20ml with normal saline and 20ml normal saline respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion of dexmedetomidine 0.4μg/kg made up to 20ml and 20ml normal saline every houruntil 30 min before the end of operation, respectively.
15879544|NCT03808454|Other|Rehabilitation|strengthening ex, posture training,...
15879332|NCT03809910|Device|Reference MTB|Participants will brush their teeth with manual toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 1-timed minute under supervision of study staff.
15879333|NCT03809910|Device|Reference PTB|Participants will brush their teeth with power toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 2-timed minute under supervision of study staff.
15879334|NCT03809910|Device|Prototype PTB (Gum line mode)|"Participants will brush their teeth with prototype PTB toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 2-timed minute in Gum Line mode under supervision of study staff."
15879335|NCT03809910|Device|Prototype PTB (Combined mode)|"Participants will brush their teeth with prototype PTB toothbrush and 1.3 g ± 0.1 g of fluoride toothpaste (containing 0.76% w/w sodium monofluorophosphate) for 2-timed minute in Gum Line mode and 1-timed minute in Interdental mode under supervision of study staff."
15879336|NCT03809897|Drug|Varenicline|All participants randomized to varenicline will be titrated to the full dose during the first week and continued up to week 12 following standard dosage. This would be independent of time of discharge, so patients will continue the same treatment after discharge up to complete the 12 weeks.
15879337|NCT03809897|Drug|Nicotine patch|Patients randomized to nicotine patch will receive 8 weeks of 21mg patch followed by 2 weeks of 14 mg patch and 2 weeks of 7 mg patch.
15879338|NCT03809884|Behavioral|Dietary Counselling|Individually tailored strategy to increase potassium in the diet.
15879339|NCT03809884|Drug|Potassium Citrate|Dosing of 50 to 100 mmol of potassium citrate per day (as 25 to 50 ml of the liquid solution).
15879340|NCT03809871|Biological|Cardiometabolic biomarkers|This is for measures of cholesterol (HDL, LDL and total cholesterol), blood glucose and HbA1c, vitamin D, vitamin B12 and iron levels.
15879341|NCT03809858|Other|Klue App|The Klue App utilizes an Apple Watch to detect eating or drinking behavior. The App can initiate a sequence of questions when eating/drinking is detected to determine if a subject has administered a bolus for the meal or if they need to do so.
15879342|NCT03809845|Device|High-density surface electromyography|High-density surface electromyography
15879343|NCT03809832|Diagnostic Test|Microbiological sampling|An microbiological sampling of the ventilator humidifier will be performed.
15879344|NCT03809819|Procedure|laparoscopic Vecchietti vaginoplasty|Patients who underwent laparoscopic Vecchietti vaginoplasty
15879345|NCT03809819|Diagnostic Test|FSFI questionnaire|Completion of FSFI questionnaire
15879346|NCT03809819|Diagnostic Test|UDI-6 questionnaire|Completion of UDI-6 questionnaire
15879347|NCT03809819|Diagnostic Test|IIQ-7 questionnaire|Completion of IIQ-7 questionnaire
15879348|NCT03809806|Procedure|4-arm polypropylene mesh surgery|Pelvic reconstructive procedures were performed with the use of 4-arm mesh:upper arms through- anterior part of obturator foramens, lower arms-ischiorectal fossas and sacrospinal ligaments.
15879349|NCT03809806|Diagnostic Test|The Female Sexual Function Index (FSFI) questionnaire|patients fulfilled questionnaire before and 1 year after procedure
15879350|NCT03809806|Diagnostic Test|King Health Questionnaire (KHQ)|patients fulfilled questionnaire before and 1 year after procedure
15879351|NCT03809806|Diagnostic Test|Pelvic Organ Prolapse Quantification (POPQ) staging|Pelvic Organ Prolapse staging before and 1 year after the procedure
15879352|NCT03809806|Diagnostic Test|Postoperative questionnaire|Postoperative questionnaire assessing quality of life fulfilled by patients 1 year after procedure
15879353|NCT03809806|Diagnostic Test|The Short Form Health Survey (SF 36) questionnaire|patients fulfilled questionnaire before and 1 year after procedure
15879354|NCT03809793|Other|Exercise Program|12-week walking based intervention (3 sessions per week)
15879355|NCT03809793|Diagnostic Test|DXA|Participants will undergo an assessment of body composition (DXA)
15879356|NCT03809793|Diagnostic Test|MRI|used to measure fat stored in the liver
15879357|NCT03809793|Diagnostic Test|Hyperinsulinaemic Euglycaemic Clamp|Participants will arrive at the laboratory after an overnight fast (>10 h) to undergo a Hyperinsulinaemic euglycaemic clamp to assess whole-body insulin sensitivity. Plasma glucose will be measured at regular intervals and muscle biopsies will be obtained from the vastus lateralis muscle of one leg before and after 2 hours of the clamp.
15879358|NCT03809793|Diagnostic Test|VO2 Max|Assessment of maximum aerobic capacity.
15879359|NCT03809793|Diagnostic Test|Continuous Glucose Monitor|CGM sensor will be inserted to measure insulin sensitivity over a 24hr period.
15879360|NCT03809793|Procedure|Muscle Biopsies|Participants will undergo muscle biopsies pre and post the hyperinsulinemic euglyceamic clamp from the vastus lateralis.
15879361|NCT03809793|Drug|Acipimox 250 MG|Participants will be randomised into two groups. One group will be prescribed Acipimox that will be taken 1 hour prior to each exercise session. The other group will take no drug.
15879362|NCT03809780|Drug|Lenalidomide|-high dose: [lenalidomide 25mg day 1-21 plus dexamethasone 20mg weekly] -Low dose: [lenalidomide 15mg day 1-21 plus dexamethasone 10mg weekly]
15879363|NCT03809780|Drug|Dexamethasone|-high dose: [lenalidomide 25mg day 1-21 plus dexamethasone 20mg weekly] -Low dose: [lenalidomide 15mg day 1-21 plus dexamethasone 10mg weekly]
15879364|NCT03809767|Drug|CS1003 monoclonal antibody|CS1003 will be administered intravenously every 3 weeks.
15879365|NCT03809754|Procedure|Percutaneous Coronary Intervention under OCT|After randomization, subjects receive primary PCI under the guiding of OCT
15879366|NCT03809754|Procedure|Percutaneous Coronary Intervention under Angiography|After randomization, subjects receive primary PCI under the guiding of angiography
15879367|NCT03809741|Other|Bundled L&D Infection Prevention Interventions|"The following bundle of infection prevention interventions will be implemented at each study site for 12 weeks:
~Education: 2 day module of Infection Prevention and Control (IPC) training and education at the beginning of the period, with specific information pertaining to labor and delivery. A refresher course will be administered at week 6.
~Feedback: Monthly feedback sessions detailing IPC practices
~Reminders: Visual poster reminders on hand hygiene and daily SMS reminders on best practices for peripartum and postnatal care.
~Alcohol Hand Rub (AHR) supply: Provision of AHR, produced by WHO standards and guides in collaboration with district pharmacy"
15879368|NCT03809728|Procedure|endoscopic biopsy|Per-endoscopic biopsies
15879369|NCT03809728|Procedure|samples of the oral cavity|7 samples of the oral cavity with a swab
15879370|NCT03809728|Procedure|Samples of the resected specimen|if patient has to undergo a digestive resection as part of his standard management, samples of the pathological area and samples at the end of the resection will be realised
15879371|NCT03809715|Device|Coroflex® ISAR NEO coronary stent system|"treatment of coronary artery disease with Coroflex® ISAR NEO of real world de-novo and restenotic lesions in native coronary arteries and coronary bypass grafts"
15879372|NCT03809702|Drug|Pregabalin|Pain score in group 1 (intervention group) will be compared with pain score in group 2 (placebo group)
15879373|NCT03809702|Drug|Placebo|Pain score in group 1 (intervention group) will be compared with pain score in group 2 (placebo group)
15879374|NCT03809689|Other|68Ga-NODAGA-RGD PET/CT|intravenous injection of 200 Megabecquerel (MBq) 68Ga-NODAGA-RGD followed by a whole-body acquisition after injection and one hour after injection
15879375|NCT03809689|Diagnostic Test|82-Rb PET/CT as part of standard care, not a comparator|2 intravenous injections of standard dose of 82-Rb : the first followed by an at-rest acquisition, the second followed by a pharmacological myocardial stress acquisition
15879376|NCT03809676|Other|periodontal examination|clinical measurements were recorded
15879377|NCT03809663|Drug|Tezepelumab|Solution for injection
15879378|NCT03809663|Other|Placebo|Placebo solution for injection
15879379|NCT03809650|Drug|macitentan 10 mg|macitentan 10 mg, film-coated tablet, oral use
15879380|NCT03809637|Drug|Pemetrexed, cisplatin|Pemetrexed 500mg/m2, Intravenous, Q 3weeks. Cisplatin 75mg/m2, Intravenous, Q 3weeks. Combination administration : up to 6cycles After 6 cycle, pemetrexed alone is administered.
15879381|NCT03809624|Drug|INBRX-105 - PDL1x41BB antibody|The active ingredient of INBRX-105 is a recombinant, humanized, bispecific IgG antibody that targets the human programmed death-ligand 1 (PD-L1) receptor and the human 4-1BB receptor.
15879382|NCT03809624|Drug|Pembrolizumab|Pembrolizumab 200 mg by intravenous (IV) infusion, given on Day 1 of each 21-day cycle.
15879383|NCT03809611|Drug|UNR844-Cl|1.5% Ophthalmic solution for topical ocular administration
15879384|NCT03809611|Drug|Placebo|placebo
15879385|NCT03809598|Behavioral|Mindfulness Based Cognitive Therapy|"See Mindfulness Based Cognitive Therapy (MBCT) Arm description"
15879386|NCT03809572|Behavioral|Mindfulness Based Cognitive Therapy|See Arm description
15879387|NCT03809559|Device|MRCP+|Participants will undergo an initial abdominal MRI scan in a fasted state. They will then be asked to drink 400ml pineapple juice before undergoing four further abdominal MRI scans with short breaks in between each scan.
15879388|NCT03809546|Drug|Dronabinol|THC (Marinol® [dronabinol]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 mg, in opaque capsules with dextrose filler. Placebo capsules contain only dextrose. These doses of THC are known to produce performance impairments as well as subjective intoxication with little to no adverse reactions in experienced occasional, but non-daily cannabis users (Ménétrey et al., 2005; Issa et al. 2016).
15879389|NCT03809546|Drug|dextrose|We are administering dextrose to health volunteers for our placebo group
15879391|NCT03809520|Radiation|pedCAT|Weight-bearing CT scan (pedCAT) of ankles to measure 3D joint space width following ankle fracture.
15879392|NCT03809507|Other|Qualtrics survey questions|"Qualtrics Survey:
~For each of the scenarios, practitioners will be asked whether opioids are prescribed or not, and the type(s) of other analgesic medications that would be prescribed, the strength in mg, and the number of doses for each medication"
15879393|NCT03809494|Device|HemaTrate™ Blood Filtration system|Anticoagulated whole blood is loaded into the filtration system. During gravity filtration, the majority of platelets, plasma, and red blood cells pass through the filter into a filtrate bag. The TNCs are captured in the filter material and recovered via a back-flush with 0.9 % saline into a syringe.
15879394|NCT03809494|Other|Saline|Normal (0.9%) saline
15879395|NCT03809481|Drug|Danaparoid Sodium|inhibits thrombin generation by indirect anti-Xa inhibition and direct inhibition of factor IX activation
15879396|NCT03809481|Drug|Argatroban|Synthetic direct thrombin inhibitor
15879397|NCT03809468|Other|phone call follow up|instead of a clinic visit, patients will be randomized to a phone call
15879398|NCT03809455|Drug|Fentanyl citrate|"Fentanyl citrate arm (FAR Arm): one intake of fentanyl citrate 100 µg (intranasal or buccal).
~Placebo Arm: one intake of placebo (intranasal or buccal) The administration route will be left to the discretion of the investigator taking into account the patient's profile (capable of maintaining the sublingual tablet without swallowing, absence of nasal discharge…), and/or the patient's choice.
~Medication Commercial name Formulation Administration route Dose Fentanyl citrate Pecfent® Nasal spray Intranasal 100 µg Fentanyl citrate Abstral® Sublingual tablet Buccal 100 µg For the cohort the choice of treatment by FAR is at the centres discretion, according to standard of practice.
~Treatment duration: 1 day"
15879399|NCT03809455|Drug|Placebo|one intake of placebo (intranasal or buccal)
15879400|NCT03809442|Drug|Ropivacaine + Ketamine|Patients will receive subcutaneous wound infiltration with total volume of 24 mL of 0.25% ropivacaine + 1mg/kg ketamine (8 mL per incision) (ketamine group).
15879401|NCT03809442|Drug|Ropivacaine + Tramadol|Patients will receive subcutaneous wound infiltration with total volume of 24 mL of 0.25% ropivacaine + 2mg/kg tramadol (8 mL per incision) (Tramadol group).
15879402|NCT03809442|Drug|Ropivacaine + Midazolam|Patients will receive subcutaneous wound infiltration with total volume of 24 mL of 0.25% ropivacaine + 50 μg/kg midazolam (8 mL per incision) (Midazolam group).
15879403|NCT03809442|Drug|Ropivacaine + Dexmedetomidine|Patients will receive subcutaneous wound infiltration with total volume of 24 mL of 0.25% Ropivacaine + 0.5μg/kg dexmedetomidine (8mL per incision) (Dexmedetomidine group).
15879404|NCT03809442|Drug|Ropivacaine + Dexamethasone|Patients will receive subcutaneous wound infiltration with total volume of 24 mL of 0.25% ropivacaine+ 8mg dexamethasone (8 mL per incision) (Dexamethasone group).
15879405|NCT03809442|Drug|Ropivacaine|Patients will receive subcutaneous wound infiltration with 24ml of 0.25% Ropivacaine in three divided doses (i.e. 8 mL per incision) (control group). Total dose of Ropivacaine will be 60 mg.
15879406|NCT03809429|Drug|FE 999049 + GnRH agonist (GONAPEPTYL)|FE 999049 + GnRH agonist (GONAPEPTYL)
15879407|NCT03809429|Drug|FE 999049 + GnRH antagonist (CETROTIDE)|FE 999049 + GnRH antagonist (CETROTIDE)
15879545|NCT03808454|Combination Product|PRP+Rehabilitation|combine PRP and Rehabilitation
15879408|NCT03809416|Device|Lasers|Fractional carbon dioxide laser will be applied only over spots of deep post-acne scars, while Erbium: Glass will be applied all over face except to the two predetermined spots, i.e. control and another spot where NSS will be injected.
15879409|NCT03809416|Other|Platelets Rich Plasma|Platelet Rich Plasma (PRP) will be prepared from autologous blood collection in a syringe prefilled with anticoagulant solution followed by centrifugation then adding calcium gluconate 10% for induction of platelet activation. Activated PRP will be injected for all carbon dioxide laser spots in each patient immediately after each laser session except for two predetermined spots, i.e. control and sham comparator, which will be injected by normal saline solution (NSS).
15879410|NCT03809416|Combination Product|Lasers plus Normal Saline Solution|Normal Saline Solution will be injected only in one spot after combined lasers resufacing to act as sham comparator compared to the other spot of Lasers plus PRP injection
15879411|NCT03809390|Procedure|Vaginal seeding|The same as that stated in arm descriptions.
15879412|NCT03809377|Procedure|Blood donation during radiotherapy|Participants will be asked to donate a blood sample at 5 time points during and after radiotherapy
15879413|NCT03809364|Behavioral|START Together|Behavioral intervention using a cognitive behavioral couple therapy (CBCT) framework designed to improve the couple's communication and problem-solving behavior.
15879414|NCT03809351|Drug|[F-18]AV-1451-PET|All study participants will undergo brain imaging with [F-18]AV-1451-PET/MRI. [F-18]AV-1451 is a PET imaging agent used primarily to measure the amount of abnormal tau protein deposition the brain.
15879415|NCT03809338|Diagnostic Test|amh test|Antral follicle count with ultrasound on the 3rd day of menstruation
15879416|NCT03809325|Drug|Paliperidone Palmitate 3-Month Formulation (PP3M)|No intervention will be administered as a part of this study. Participants who have been treated with PP3M in clinical practice will be enrolled.
15879417|NCT03809312|Drug|Amoxicillin / Clavulanic acid 875mg / 125mg|Amoxicillin / Clavulanic acid 875 mg / 125 mg BID x 10 days
15879418|NCT03809312|Drug|Placebos|Placebos BID x 10 days
15879419|NCT03809299|Other|Ad libitum meal timing|Research participants will eat meals provided by the study throughout the day, ad libitum
15879420|NCT03809299|Other|Twice a day meals|Research participants will eat meals provided by the study at two intervals during the day, and fast in between.
15879421|NCT03809286|Device|active rTMS|rTMS delivers magnetic stimulation to the brain by using an electromagnet to generate a current that can penetrate the scalp and skull.
15879422|NCT03809286|Behavioral|Inpatient admission|All subjects will be admitted to the hospital for a brief detoxification period followed by 3 weeks of abstinence.
15879423|NCT03809286|Device|sham rTMS|The sham coil setting is designed to mimic the auditory artifact and the scalp sensations evoked by the real coil, and to produce activation of facial muscles similar to the effect of a real H coil, without stimulating the brain itself.
15879424|NCT03809273|Drug|Yangxinshi|Yangxinshi pill 3 pills /tid
15879425|NCT03809273|Drug|Trimetazidine|Trimetazidine 20mg/tid
15879426|NCT03809273|Drug|Yangxinshi mimic|Yangxinshi mimic tablets 3 pills /tid
15879427|NCT03809273|Drug|Trimetazidine mimic|Trimetazidine mimic tablets 20mg/tid
15879428|NCT03809260|Drug|Metformin (part 1)|1~4d: Metformin 1000 mg bid (Except for 500 mg after 1d lunch), 16d~19d: Metformin 1000 mg bid (Except for 500 mg after 16d lunch).
15879429|NCT03809260|Drug|Vancomycin|11d: Vancomycin 250 mg bid, 12~17d: Vancomycin 500 mg bid
15879430|NCT03809260|Drug|Metformin (part 2)|1~4d: Metformin 1000 mg bid (Except for 500 mg after 1d lunch)
15879431|NCT03809234|Drug|Ondansetron 8mg with Saline & Tariquidar|Each participant will receive two IV infusions of ondansetron, 24 hours apart. In the first and second sessions, respectively, placebo (D5W) or tariquidar (4mg/kg dose in D5W) 22 will be administered IV over 60 minutes. Ondansetron will be diluted in 50mL 0.9% normal saline, and tariquidar will be diluted in 250mL D5W.
15879432|NCT03809234|Drug|Ondansetron 16mg with Saline & Tariquidar|Each participant will receive two IV infusions of ondansetron, 24 hours apart. In the first and second sessions, respectively, placebo (D5W) or tariquidar (4mg/kg dose in D5W) 22 will be administered IV over 60 minutes. Ondansetron will be diluted in 50mL 0.9% normal saline, and tariquidar will be diluted in 250mL D5W.
15879433|NCT03809221|Drug|Triptorelin acetate|Achieve pituitary down regulation with triptorelin acetate and start controlled ovarian stimulation after complete pituitary down regulation
15879434|NCT03809195|Behavioral|Clinical Hypnosis|See information in arm/group description. Four different audio recordings are provided electronically, each approximately 20 minutes in length. Participants are encouraged to listen to one daily.
15879435|NCT03809182|Drug|Dexmedetomidine|A bolus of 1ug/kg in 10 minutes, followed by an infusion of 0.5ug/kg/h until the end of surgery.
15879436|NCT03809182|Drug|0.9% Sodium-chloride|The same infusion rate used in the dexmedetomidine group.
15879437|NCT03809182|Drug|Fentanyl|Intraoperative fentanyl was given in case of 25% increment in the blood pressure and/or heart rate in comparison to baseline (previous anesthesia induction).
15879438|NCT03809182|Drug|Morphine Sulfate|Boluses of 3mg of intravenous morphine were given in the postoperative acute care unit. Once the pain score was equal or less than 3/10 the patient-controlled analgesia pumps were installed and the patients were discharged to their room.
15879439|NCT03809169|Procedure|Rapid on-site evaluation (ROSE)|Pathologist on site for direct evaluation of specimen adequacy
15879440|NCT03809169|Procedure|Slim bronchoscope without a guide sheath|peripheral endobronchial ultrasound performed with a slim bronchoscope (3.0 mm outer diameter with a 1.7mm channel) combined with a radial ultrasound probe but without the use of a guide sheath.
15879441|NCT03809169|Procedure|Standard pEBUS with guide sheath|Using a flexible bronchoscope with minimal outer diameter of 4.2mm.
15879442|NCT03809156|Drug|Riociguat Oral Product|Dual therapy of Riociguat and Ambrisentan at initiation of treatment.
15879443|NCT03809143|Drug|RBP-6000|All study participants are scheduled to receive monthly subcutaneous injections of depot BPN, RBP-6000. RBP-6000 (BPN in the ATRIGEL® Delivery System) contains buprenorphine (200mg/mL) in the ATRIGEL® Delivery System, which provides sustained plasma level of BPN over a minimum of 28 days.
15879444|NCT03809130|Other|Internet-Based Intervention|Use Untire application after baseline up to 6 months
15879445|NCT03809130|Other|Internet-Based Intervention|Use Untire application after 3 months up to 6 months
15879446|NCT03809130|Other|Quality-of-Life Assessment|Ancillary studies
15879448|NCT03809117|Diagnostic Test|Biofire Film Array Gastrointestinal Panel|The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.
15879449|NCT03809104|Other|Virtual reality-based rehabilitation programs|A virtual reality (VR)-based rehabilitation program that lasts for 12 weeks, twice per week, 30 minutes per time. The program was combined with progressive resistant training and functional movement of dominant upper (UE) limb. The device of the VR including one computer, one oculus headset, and one hand-hold sensor. The rehabilitation secession contains 4 different VR games in total, including (1) Leap Motion Blocks (2) Slum Ball VR Tournament (3) VR Super Sports 10th Edition- Basketball (4) VR Super Sports 10th Edition- Soccer.
15879450|NCT03809091|Diagnostic Test|Whole genome sequencing|Whole genome sequencing of patients and their family will be performed. Among the variants detected by WGS, disease-causing variants will be analyzed by using segregation analysis.
15879451|NCT03809078|Drug|68Ga RM2|PET radiopharmaceutical
15879452|NCT03809078|Drug|68Ga-PSMA-11|PET radiopharmaceutical
15879453|NCT03809078|Device|Investigational PET scanner coils and software|GE Healthcare non-approved PET scanner coils and software
15879454|NCT03809065|Drug|Nitroglycerin|Nitroglycerin is a direct vasodilator and its main action is through venodilation. Nitroglycerin will be diluted by adding 3 mL (3 mg) to 47 mL normal saline in a 50 mL syringe and will be infused after endotracheal intubation with a starting dose of 0.5 mL/Kg/ hr to have a starting dose of 0.5 μg/Kg/min. The rate of nitroglycerin infusion will be 0.5-2 μg /kg/min .The infusion rate will be finely adjusted to maintain MAP around 55-65mmHg or till reaching adequate surgical field {defined as surgical field score (SFS) <3}.
15879455|NCT03809065|Drug|Labetalol|Labetalol is an α and β - adrenergic receptors competitive antagonist. Labetalol will be diluted by adding 10 mL (50 mg) to 40 mL normal saline in a 50 mL syringe and will be infused after endotracheal intubation with a starting dose of 0.5 mL/Kg/ hr. The rate of Labetalol infusion will be 0.5-2 mg/kg/h.The infusion rate will be finely adjusted to maintain MAP around 55-65mmHg or till reaching adequate surgical field {defined as surgical field score (SFS) <3}.
15879456|NCT03809052|Drug|GB1211|Hard capsules for oral use
15879457|NCT03809052|Drug|Placebo|Hard capsules for oral use
15879458|NCT03809039|Drug|MT-6345|MT-6345
15879459|NCT03809039|Drug|MT-6345 Placebo|MT-6345 Placebo
15879460|NCT03809013|Drug|RC48-ADC|2.0mg/kg IV every 2 weeks
15879461|NCT03809000|Radiation|Radiation Therapy|Radiation Therapy
15879462|NCT03809000|Drug|Enzalutamide|Anti-androgen
15879463|NCT03809000|Drug|Bicalutamide|Anti-androgen
15879464|NCT03809000|Drug|GnRH analog|Anti-androgen
15879465|NCT03808987|Behavioral|Child-Parent Psychotherapy (CPP)|Child-Parent Psychotherapy (CPP) focuses on parent-infant relationships, increases efficacy for improved mother-child relationships, more sensitive parenting, healthier child development, and maltreatment prevention. A primary goal is to strengthen the parent-child relationship to improve family functioning and child security of attachment. Through respect, empathic concern, and positive regard, the therapeutic relationship provides mothers with corrective emotional experiences, through which they are able to differentiate current from past relationships, form positive internal representations of themselves and of themselves in relationship to others, particularly their children. Parents are encouraged to process their experiences of trauma and restore parental roles as protective shields, improve affective regulation capacities, enhance understanding of the meaning of behavior, acknowledge the impact of trauma, and support children in a more positive developmental trajectory.
15879466|NCT03808987|Behavioral|Community Health Worker (CHW) home visitation|Community Health Worker (CHW) home visitation includes assistance with concrete support needs, such as transportation to medical appointments, referrals for food, housing, and employment services, and attention to developmental needs of young children.
15879467|NCT03808974|Other|Educational video|Short educational video describing the mid-urethral sling procedure
15879468|NCT03808974|Other|Educational leaflet|Standard educational leaflet describing the mid-urethral sling procedure
15879469|NCT03808961|Dietary Supplement|Niacin|100mg tablets twice daily
15879470|NCT03808961|Dietary Supplement|Niacinamide|100mg tablets twice daily
15879471|NCT03808961|Other|Placebo|Placebo tablet
15879472|NCT03808948|Device|VFI|The IV-administered visible fluorescent injectate (VFI)™ agent comprises a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.
15879473|NCT03808935|Drug|Medical Cannabis|The experimental intervention will begin with two weeks of titration (100 mg to 200 mg of CBD per day), followed by four weeks of treatment (maximum 300 mg of CBD per day) and four weeks of maintenance (maximum 300 mg of CBD per day). A two week washout phase will slowly decrease the daily dose (200 mg to 100 mg of CBD per day). All daily doses are equally divided into a morning and evening dose.
15879474|NCT03808935|Drug|Placebo|The placebo intervention will begin with two weeks of titration, followed by four weeks of treatment. Participants will then be unblinded to their study group and begin two weeks of titration, four weeks of treatment, and two weeks of washout with medical cannabis, following the same dosing and schedule as the experimental group. All daily doses are equally divided into a morning and evening dose.
15879475|NCT03808922|Drug|DAS181|DAS181 4.5mg nebulized qd x 7 OR 10 days
15879476|NCT03808922|Drug|Placebo|Placebo nebulized qd x 7 OR 10 days
15879477|NCT03808922|Drug|DAS181 COVID-19|DAS181 4.5mg nebulized q12h/day x 7 OR 10 days
15879478|NCT03808922|Drug|DAS181 OL|DAS181 4.5mg nebulized qd x 7 OR 10 days ≥ 40kg DAS181 2.5mg nebulized qd x 7 OR 10 days < 40kg
15879479|NCT03808909|Other|Continuous Labor Support|Participants in the intervention condition will be assigned a doula who is a lay person trained to provide emotional and practical support to individuals throughout labor and delivery.
15879480|NCT03808896|Procedure|stylet-assisted epiglottic lifting|use stylet-equipped enodtracheal tube to lift the epiglottis and pass the endotracheal tube
15879481|NCT03808896|Device|bougie-assisted intubation|use bougie as a introducer. Pass the bougie to the trachea and pass the tube via bougie guide.
15879482|NCT03808883|Behavioral|TGNC Directed Advocacy Meetings|Series of community meetings with TGNC individuals to include meeting with health professionals to articulate barriers to access and to enter into dialogue with medical providers and staff
15879484|NCT03808857|Biological|GB226|GB226 is administrated at the dose of 3mg/kg, once per 2 weeks (±3 days), and distributed in 100ml of 0.9% sodium chloride solution. The concentration of GB226 shall be strictly controlled at 1mg/ml~10mg/ml, the duration is 60 min (±10 min) for the first infusion of the drug, and can be reduced to 30 min (±10 min) for the subsequent infusion of the drug if there is infusion related adverse reaction.
15879485|NCT03808844|Drug|HSK3486|Initial dose of 0.4 mg/kg followed by 0.2 mg/kg if needed.
15879486|NCT03808844|Drug|Propofol|Initial dose of 2.0 mg/kg followed by 1.0 mg/kg if needed
15879487|NCT03808831|Device|Fall detection and prevention system|The fall detection and prevention system records near-fall and fall events; meanwhile, it alarms subjects while detecting near-fall events and alarms caregivers while detecting fall events.
15879488|NCT03808831|Device|Sham fall detection and prevention system|The sham system with record but no alert function
15879489|NCT03808818|Other|Behavioral, Psychological or Informational Intervention|Receive information about tobacco cessation
15879490|NCT03808818|Drug|Nicotine Replacement|Given NRT patch or lozenge (or both)
15879491|NCT03808818|Other|Quality-of-Life Assessment|Ancillary studies
15879492|NCT03808818|Other|Survey Administration|Ancillary studies
15879493|NCT03808818|Other|Tobacco Cessation Counseling|Receive virtual tobacco cessation counseling
15879494|NCT03808805|Drug|Aprepitant 80 mg|oral therapy - daily dose - 14 days
15879495|NCT03808805|Drug|Hydroxyzine 25mg|oral therapy - daily dose - 14 days
15879496|NCT03808805|Drug|Placebo of Hydroxyzine|oral therapy - daily dose - 14 days
15879497|NCT03808805|Drug|Placebo of Aprepitant|oral therapy - daily dose - 14 days
15879498|NCT03808792|Diagnostic Test|Ultrasound, CT and WB-DWI/MRI|Preoperative assessment with Ultrasound, CT and WB-DWI/MRI
15879499|NCT03808779|Procedure|Radiofrequency Ablation|Patients were supine with the neck exposure completely during the procedure. Local anesthesia with 1% lidocaine was injected at the subcutaneous puncture site and the thyroid anterior capsule. If the distance between the tumor and critical cervical structures was less than 5 mm, normal saline was injected to form at least 1 cm distance between the tumor and the critical structure to prevent the unwilling thermal injury. RFA was performed using the moving-shot technique and RFA power was 5 W, if a transient hyperechoic zone did not form at the electrode tip within 5-10 seconds. The RFA extent exceeded the tumor edge to prevent marginal residue and recurrence. The ablation was terminated when all portions of the target ablation area had changed to hyperechoic zones.
15879500|NCT03808779|Procedure|Conventional Surgery|Patient is performed total thyroidectomy or thyroid lobectomy depending on the intraoperative situation, disease condition and comprehensive judge by surgeon. Patients are routinely disinfected and spread the drapes after general anesthesia. Neck skin, fat and placenta muscle are incised and separated successively. The flap is separated to the upper edge of thyroid cartilage, neck white line is incised and anterior muscle group is separated. Then both sides thyroid lobes are exposed. Cut off the isthmus, ligature the thyroid artery, cut off the upper pole. Ligature and cut off the ipsilateral thyroid vein. Reveal and protect the ipsilateral recurrent laryngeal nerve and the parathyroid gland during the entire process.
15879501|NCT03808766|Other|embolization|Patient with a diagnosis of HCC and a treatment plan to receive partial hepatectomy will receive transarterial embolization under local anesthesia 2 weeks before the surgery. Angiographic examinations of the tumor before and after embolization of the tumor will be performed. Histological examination of the tumor in the surgical specimens will be performed.
15879502|NCT03808753|Diagnostic Test|End-expiratory occlusion test (EEOT)|The EEOT is performed by interrupting the mechanical ventilation for 30 seconds, by using and end-expiratory hold on the ventilator.
15879503|NCT03808753|Other|mini fluid challenge (mFC)|The mFC is performed by injecting a first aliquot of 100 ml of crystalloid over 1 minute before completing the 4 ml/kg-FC over the residual 9 minutes.
15879504|NCT03808740|Drug|Atomoxetine|atomoxetine 0.5 mg/kg/day.
15879505|NCT03808740|Drug|Placebo|sugar pill
15879507|NCT03808714|Behavioral|TOUCHDOWN|We expect the intervention to consist of 3 to 4 group sessions and at least one individual session plus pharmacological consultation(s) via Skype, but this will be determined during pretesting. CHWs will have IPads with cellular connectivity and will be present when the pharmacological approach is discussed with the participant so that they can reinforce the message with the participant and be the liaisons between the participant and physician.
15879508|NCT03808714|Behavioral|Control Group|Alabama Quitline
15879509|NCT03808701|Drug|SCT200|Recombinant Anti-EGFR Monoclonal Antibody
15879510|NCT03808688|Drug|Netarsudil Ophthalmic Solution 0.02%|1 drop in each eye once daily in the evening
15879511|NCT03808675|Behavioral|Aerobic walking|The investigators will use self-administered continuous walking exercise at a moderate intensity level, defined as 40-59% of heart rate reserve or 64-77% of heart rate at gas exchange threshold (HRGET) by ACSM as in the investigators' preliminary study (PMID: 24991037 PMCID: PMC4132568). The HRGET will be determined as the heart rate at VO2max during graded cycle ergometry. The total duration of the exercises will be 150 min/week per 2008 Physical Activity Guidelines for Americans and American Heart Association recommendations, conducted in three 50 min sessions. The aerobic walking intervention will take place outdoors (e.g., trails, sidewalks, parks) or indoors (e.g., track in a local gym or a mall) depending on the preferences of the subject and weather. Session duration will be 20 min the first week and will be advanced by 5 min per week over 6 weeks.
15879546|NCT03808441|Other|ctDNA analysis|Regular ctDNA analysis, which upon a decrease in mutant BRAF VAF (variant allele frequency) level of ≥80% the switch to N+I is triggered.
15879547|NCT03808428|Device|Ankle Group|Provide sensory feedback to help subjects relearn how to walk in correct gait pattern.
15879548|NCT03808415|Device|EMG-driven|The EMG signals are processed and can be visualized with visual feedback to make sure the user actively engaging throughout a therapy session.
15879549|NCT03808389|Other|Donor FMT|Fecal microbiota transplantation through nasojejunal administration. Fecal matter will be collected prior to the start of the study from healthy donors and will be frozen at -80°C after thorough screening for infectious diseases. At the time of transplantation, samples will be thawed and administrated to the patients in the treatment group.
15879512|NCT03808675|Behavioral|Usual care with PD specific health education|"In this study, patients will receive their usual medical treatment for motor and non-motor symptoms from their
~primary neurologist. The investigators will use a streamlined form of PD specific health education prepared by the VA: My Parkinson's Story, which consists of a series of short videos prepared by the VA PADRECCs addressing various aspects of PD. These 6-12 minutes long videos are freely available on YouTube. The investigators can also provide them on a CD if subjects desire. They start with a patient testimony about the topic of the episode, followed by comments of experts in the field. The title of the episodes are: Early Parkinson's, Medications, Exercise, Memory, Visual Disturbances, Depression, Sleep, Speech and Swallowing, Impulsive Behaviors, Driving, Pain, Dyskinesias, Deep Brain Stimulation, Advanced Parkinson's Disease, Falls, The Caregiver, Hospitalization, Genetics, Environmental Exposure, Atypical Parkinsonism"
15879513|NCT03808662|Radiation|Sterotactic Body Radiotherapy/SBRT|In general, it is recommended using 9-10 Gy x 3 or 10 Gy x 5 fractions given every other day. Physicians should try to give the highest BED whenever possible while respecting normal tissue tolerance. All lesions are recommended to receive a biologically effective dose (BED) of 60 Gy or higher (BED10≥70), assuming α/β ratio of 10 and using the linear-quadratic model: BED = nd x [1 + d/(α/β)] where n is number of fractions and d is dose per fraction. Sometimes BED ≥80 Gy is preferred, with lower doses ≥50 Gy allowed at the discretion of the treating physician for concerns about normal tissue toxicity.
15879514|NCT03808662|Drug|Standard of care|Standard of care per physician discretion
15879515|NCT03808649|Drug|1500ml of 2.5% mannitol|1500ml of 2.5% mannitol was used in experimental group
15879516|NCT03808649|Drug|different volume of 2.5% mannitol|different volume of 2.5% mannitol based on BMI was used in active comparator group
15879517|NCT03808623|Device|MAC with NOVOCART Basic|"NOVOCART® Basic is a biphasic, collagen-based matrix to support the biological reconstruction of localized and full-thickness cartilage damages after treatment with bone marrow stimulation techniques (microfracture). The procedure is called matrix associated chondrogenesis (MAC). It is a single-step procedure.
~NOVOCART® Basic is tailored to fit the prepared defect size and is inserted in the defect area after microfracture. The NOVOCART® Basic device component is fully resorbed over a period of a few months as new reparative cartilage tissue is generated and integrated with the surrounding host tissue."
15879518|NCT03808610|Drug|Cyclophosphamide|Given IV
15879519|NCT03808610|Drug|Cytarabine|Given IV
15879520|NCT03808610|Drug|Dexamethasone|Given IV or PO
15879521|NCT03808610|Drug|Methotrexate|Given IV
15879522|NCT03808610|Drug|Nelarabine|Given IV
15879523|NCT03808610|Drug|Pegaspargase|Given IV
15879524|NCT03808610|Drug|Prednisone|Given PO
15879525|NCT03808610|Biological|Rituximab|Given IV
15879526|NCT03808610|Drug|Venetoclax|Given PO
15879527|NCT03808610|Drug|Vincristine|Given IV
15879528|NCT03808597|Other|Digital health promotion intervention|Digital health promition related to HIV, Tuberculosis and TSCT in a digital format.
15879529|NCT03808584|Other|Physiotherapy|4 specific core muscle exercises, targeting abdominal muscles, to be performed daily from postoperative day one to 2 months postsurgery.
15879530|NCT03808571|Other|cord blood specimen during the delivery|The cord blood will be taken during the delivery of baby.
15879531|NCT03808558|Drug|TVB-2640|TVB-2640 will be administered 100mg/m2 orally once a day for 8 weeks.
15879532|NCT03808545|Behavioral|Behavioral Intervention for Physical Activity in Multiple Sclerosis (BIPAMS)|This is a newly developed Internet website that delivered a Social Cognitive Theory-based behavioral intervention using e-learning and one-on-one video chats approaches for increasing physical activity and improving symptoms, walking impairment, and neurological disability. The intervention will last 16 weeks and will include physical activity information.
15879533|NCT03808545|Behavioral|BIPAMS + Diet|For 8 weeks a participant will complete the standard BIPAMS intervention. For the subsequent 8 weeks, in addition to the BIPAMS website, participants will receive a diet prescription with instructions and guidance on their one-on-one video calls and will utilize the HealthWatch360 app and/or desktop website to track their dietary intake. The total intervention will last 16 weeks and will include physical activity information and dietary information.
15879534|NCT03808532|Other|Cura+ Moisturizing Cream|Parents of at-risk infants in the intervention arm will be instructed to apply moisturizer to the infant's entire body once daily for six months.
15879535|NCT03808519|Dietary Supplement|n3 PUFA-enriched fish oil|3000mg of Eicosapentaenoic acid per day and 1800mg of Docosahexaenoic acid per day
15879536|NCT03808519|Dietary Supplement|Placebo|Organic Sunflower Oil 5000mg per day
15879537|NCT03808506|Diagnostic Test|Fecal calprotectin|Stool test to look at baseline burden of inflammation
15879538|NCT03808493|Drug|TAK-438 OD|TAK-438 OD tablet
15879539|NCT03808493|Drug|TAK-438|TAK-438 tablet
15879540|NCT03808480|Drug|CA and Nivolumab|Cyclophosphamide 500mg/m2 IV on D1 (C1-4), 1cycle=21days) Doxorubicin 50mg/m2 IV on D1 (C1~4, 1cycle=21days) Nivolumab 360 mg/IV C2~4 D1 (1cycle=21days) Nivolumab 400mg/IV on D1 from Cycle 5 every 4 weeks.
15879541|NCT03808467|Behavioral|Cognitive Remediation Therapy|Nine individual transdiagnostic CRT sessions will be delivered once per week, each session lasting approximately 45 minutes. Building on previously published CRT manuals for anorexia nervosa and obesity, a transdiagnostic CRT manual developed for this project will be used during the course of CRT treatment. The manual comprises an introduction to CRT for eating disorders, and a detailed nine-session structure incorporating cognitive and behavioral tasks in the following domains; (1) planning-impulsivity, (2) flexibility-rigidity and (3) central coherence-attention to details. A certain set of guiding questions will accompany each task with the aim of stimulating metacognition (i.e. thinking about thinking).
15879542|NCT03808467|Other|Treatment as usual|According to Norwegian guidelines established by the Norwegian Directorate of Health, the patients are likely to receive treatment focusing directly on the ED symptomatology, i.e normalization of weight in the case of underweight, reduction of binging and purging and normalization of other ED related thoughts and behaviors. Since both in-patients, patients in day treatment and out-patients will be included in the study, the number of hours with therapeutic interventions will vary. Records of the participants' received number of therapeutic hours will be logged weekly during the intervention for participants in both arms of the study.
15879543|NCT03808454|Drug|PRP|The investigators draw 10cc of blood and concentrate the blood to get the platelet rich plasma
15879550|NCT03808389|Other|Autologous FMT|Fecal microbiota transplantation through nasojejunal administration. Fecal matter will be collected prior to the start of the study from each patient and will be frozen at -80°C after thorough screening for infectious diseases. At the time of transplantation, samples will be thawed and administrated to the patients in the control group.
15879551|NCT03808376|Device|Continuous Glucose Monitoring System|The Eversense® 180 CGM System
15879552|NCT03808363|Other|High Intensity Interval Training|Participants assigned to this group will perform a very mild 5-minute warm-up (0 resistance, and 60 rpm), followed by 5 one-minute bouts of high intensity exercise, with 90 seconds between each bout. These bouts will be followed by a 3-minute cool down (0 resistance, and 60 rpm). The high-intensity exercise will be performed at an intensity of 17 on the Borg rating of perceived exertion (RPE) scale (very hard), and the 90 second active rest intervals will be performed at an intensity of 7-9 (very, very light - very light). The exercise will be performed on the NuStep machine 3 times a week for 6 weeks.
15879553|NCT03808350|Procedure|Families Invited to Be Present at Procedures|Family members will be invited (but not required) to remain in the ICU room during procedures, if patients agree
15879554|NCT03808350|Other|Placebo/Control|Family members will not be invited to remain in the ICU room
15879555|NCT03808337|Radiation|Stereotactic Body Radiotherapy/SBRT|Radiation to each metastatic site should be delivered to a minimum dose of 30 Gy in 5 fractions (BED of 48 Gy10). The exact dose of radiotherapy will be determined by the treating radiation oncologist. Preferred regimens for lung metastases include 50 Gy in five fractions, 48 Gy in four fractions, or 54 Gy in three fractions, although lower doses may be employed to respect dose limits to critical structures such as the esophagus. Recommended SBRT dosing for other sites includes 27 to 30 Gy in three fractions or 24 Gy in one fraction for bone metastases.
15879556|NCT03808337|Drug|Systemic Therapy/Standard of Care|Standard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating oncologist. For patients randomized to receive SBRT, systemic therapy can be continued during SBRT at the discretion and concensus of treating physicians (medical oncologist and radiation oncologist). If the treating physicians recommend discontinuing systemic therapy during SBRT, general guidelines for stopping and reinitiating systemic regimen are as follows: Hormonal therapies and immunotherapy can be continued during SBRT. Consideration can be given to holding cytotoxic chemotherapy beginning 3 to 7 days prior to the initiation of SBRT until 3 to 7 days after the completion of SBRT. Similarly, consideration can be given to holding biologic agents during SBRT and for 0 to 3 days before and after.
15879557|NCT03808324|Diagnostic Test|Diagnostic investigations|Participants will undergo tests and diagnostics investigations to identify signs of chronic rejection after heart transplantation.
15879558|NCT03808311|Other|Treatment strategy regarding different systolic BP goals|The trial will test a treatment strategy question regarding different systolic BP goals and not test specific medications. Therefore, the BP treatment protocol is flexible in terms of the choice and doses of anti-hypertensive medications as long as systolic BP levels are within targets (<120 mmHg in the intensive arm and <140 mmHg in the standard arm).
15879559|NCT03808298|Drug|Balovaptan therapeutic dose Treatment A|Days 1-14: A single once daily dose at dose level A of balovaptan for 14 days
15879560|NCT03808298|Drug|Balovaptan supra-therapeutic dose Treatment B|Days 1-14: A single once daily oral dose at dose level B of balovaptan for 14 days.
15879561|NCT03808298|Drug|Active control [moxifloxacin] on Day 2 Treatment C|Day 2: A single oral dose of 400 mg moxifloxacin capsule.
15879562|NCT03808298|Drug|Active control [Moxifloxacin] on Day 15 Treatment D|Day 15: A single oral dose of 400 mg moxifloxacin capsule.
15879563|NCT03808298|Drug|Placebo for Balovaptan Treatment C|Days 1-14: Matching placebo for balovaptan for 14 days.
15879564|NCT03808298|Drug|Placebo for Balovaptan Treatment D|Days 1-14: Matching placebo for balovaptan for 14 days.
15879565|NCT03808298|Drug|Placebo for Moxifloxacin Treatment A|Day 2 and 15: A single oral dose of a matching placebo capsule for moxifloxacin.
15879566|NCT03808298|Drug|Placebo for Moxifloxacin Treatment B|Days 2 and 15: Single oral dose of a matching placebo capsule of moxifloxacin.
15879567|NCT03808298|Drug|Moxifloxacin Treatment C|Day 2: A single oral dose of 400 mg moxifloxacin capsule.
15879568|NCT03808298|Drug|Placebo for Moxifloxacin Treatment C|Day 15: A single oral dose of a matching placebo capsule for moxifloxacin.
15879569|NCT03808298|Drug|Placebo for Moxifloxacin Treatment D|Day 2: A single oral dose of a matching placebo capsule for moxifloxacin.
15879570|NCT03808298|Drug|Moxifloxacin Treatment D|Day 15: A single oral dose of 400 mg moxifloxacin capsule.
15879571|NCT03808285|Other|mandibular osteomylitis|
15879573|NCT03808259|Drug|(S)-ketamine Oral Thin Film|(S)-ketamine OTF sublingual formulation at a dose of 7 mg, 14 mg, and 28 mg will be administered in sequential cohorts.
15879574|NCT03808259|Drug|(S)-ketamine IV Infusion|(S)-ketamine IV solution will be infused at a dose of less than or equal to 14mg.
15879575|NCT03808259|Drug|Placebo|Participants will receive matching placebo.
15879576|NCT03808246|Other|using the demo version of a self-injector pen|Participants, whatever the arm they are included in, will have to use the demo version of the auto-injector pen during a simulation of an anaphylactic shock.
15879577|NCT03808233|Other|ACTIVE mini|the ACTIVE-mini, is a non-invasive method of recording movement in an infant using a KINECT camera system. This camera is positioned over a resting infant and measures natural movement over a two minute time period.
15879578|NCT03808220|Behavioral|postoperative pain intensity|estimate the postoperative pain intensity by using a scaling system via questionnaire
15879579|NCT03808220|Behavioral|preoperative pain frequency|estimate the preoperative pain intensity by using a scaling system via questionnaire
15879580|NCT03808220|Behavioral|Side effect|investigate the presence of any side effect
15879581|NCT03808207|Other|Dietary counseling and DHA dietary increase in breastfeeding mothers|Specific dietary advices in order to increase the daily/weekly intake of docosahexaenoic acid of breastfeeding mothers for the first 3 months after delivery
15879744|NCT03807037|Drug|Placebo oral capsule|Matching placebo to be administered orally at 1 capsule, twice daily
15879582|NCT03808194|Other|Conditional lottery incentive|Participants in the lottery incentive arm must fulfill the following criteria to be entered into the lottery. Participants must visit the clinic by month 1, initiate ART by month 3 and achieve viral suppression by month 6. Participants in this arm will be eligible to win the lottery.
15879583|NCT03808194|Other|Optimized ART linkage package|Optimized ART linkage package
15879584|NCT03808181|Device|ChloraSolv|Weekly application of ChloraSolv for 6 weeks
15879585|NCT03808168|Drug|Nivolumab|Protocol dose: 3mg/kg mg as a 30-minute IV infusion on Day 1 (Arm I) or Days 1, 15, 29 (Arm II).
15879586|NCT03808155|Drug|Tamsulosin|The drug ist taken once a day per os five days prior to the operation and two days after the operation.
15879587|NCT03808155|Drug|Placebo Oral Tablet|The placebo ist taken once a day per os five days prior to the operation and two days after the operation.
15879588|NCT03808142|Other|myBETAapp|Patients choosing to use the myBETAapp were required to insert the Mixject number from their prescribed Betaferon box, which serves as an opening key for the app. Obtaining a new Betaferon box and obtaining a new Mixject number was not interfere with the process of continuously allocating data to a single patient; each patient had a unique personal identifier in the database. All data recorded in the myBETAapp including demographic and injection-related data were stored in the database once the mobile device was connected to the internet.
15879589|NCT03808142|Other|PEAK|Peak is an application that aims at helping its users to challenge their brains and keep them sharp.
15879590|NCT03808142|Drug|Betaferon, BAY86-5046|Injection
15879591|NCT03808142|Device|BETACONNECT|BETACONNECT automatically records and stores injection-related details including injection time, speed, and depth upon every injection.
15879592|NCT03808129|Drug|Bupivacaine and Lidocaine|ESP block was administered under general anesthesia before the surgery. Patients with ESP block, 1: 1 ratio of 0.25% bupivacaine and 0.4 ml / kg of 1% lidocaine
15879593|NCT03808116|Device|SmartBx|"he SmartBx device is intended for the retention of a biopsy specimen and for preservation of the specimen's in-needle location and orientation.
~The SmartBx is used as an aiding tool in biopsy procedures. When operated in conjunction with the standard equipment in a prostate biopsy procedure, the SmartBx may be used for the following:
~To preserve sample unity, including core fragments in their original location along the needle notch.
~Avoid sample damaging during sample removal from the needle and the following pathology process."
15879594|NCT03808103|Biological|Placebo|Orally, twice a day, for a period of fifteen days
15879595|NCT03808103|Biological|Bacteriophage preparation|Orally, twice a day, for a period of fifteen days
15879596|NCT03808090|Other|Normal Individuals|Stage I: Controlled Dietary Study Phase II: Glycolate Phase III: Vitamin C Participants that agree,will undergo MRI to evaluate fatty liver
15879597|NCT03808090|Other|Calcium Oxalate Kidney Stone Formers|Stage I: Controlled Dietary Study Phase II: Glycolate Phase III: Vitamin C Participants that agree,will undergo MRI to evaluate fatty liver
15879598|NCT03808090|Other|Type 2 Diabetes|Stage I: Controlled Dietary Study Phase II: Glycolate Phase III: Vitamin C Participants that agree,will undergo MRI to evaluate fatty liver
15879599|NCT03808090|Other|Type 2 diabetic kidney stone formers|Stage I: Controlled Dietary Study Phase II: Glycolate Phase III: Vitamin C Participants that agree,will undergo MRI to evaluate fatty liver
15879600|NCT03808077|Drug|Rocuronium 0.3mg/kg/hr|The Moderate NMB group (Control ) will have rocuronium infusion titrated to moderate paralysis defined as TOF of 1-2 (infusion start rate 0.005mg/kg/min or 0.3mg/kg/hr).
15879601|NCT03808077|Drug|Rocuronium 1.5mg/kg/hr|The Deep NMB group (Intervention) will have rocuronium infusion titrated to deep paralysis defined as PTC of 1-2 (infusion start rate 0.025mg/kg/min or 1.5mg/kg/hr).
15879602|NCT03808064|Behavioral|FCHV home visit|Behavioral: FCHV visit Female Community Health Volunteer will visit selected households 4 times a year for providing health promotion messages Other Name: FCHV Home Visit
15879603|NCT03808051|Procedure|Physiological-based cord clamping|See Arm description.
15879604|NCT03808051|Procedure|Time-based cord clamping|See Arm description.
15879605|NCT03808038|Other|None- Observational Study|None- Observational Study
15879606|NCT03808025|Behavioral|opioid education|see arm/group descriptions
15879607|NCT03808012|Other|Braking performance in a brake simulator|Braking performance is tested in a real middle size car cabin to simulate ergonomic conditions of driving a car. This testing cabin has been equipped with customised equipment to allow measurement of reaction time, foot transfer time, brake response time and brake force.
15879608|NCT03807999|Drug|Nab-paclitaxel|
15879609|NCT03807999|Drug|Gemcitabine|
15879610|NCT03807986|Procedure|Nanofat grafting|Nanofat grafting will be applied once every three months for 2 times.
15879611|NCT03807986|Procedure|Microfat grafting|Microfat grafting will be applied once every three months for 2 times.
15879612|NCT03807986|Procedure|Platelet-rich plasma (PRP) Injection|PRP Injection will be applied once a month for 6 times.
15879613|NCT03807973|Drug|[Zr-89]Oxine-labeled leukocytes PET/MR|All study participants will undergo an investigational imaging study using autologous [Zr-89]-lableled leukocytes and brain PET/MRI. Participants will undergo a venous blood draw, and the leukocutes in the blood sample will be isolated for labeling using [Zr-89]oxine. The labeled leukocutes (7.4- 18.5 MBq, 200-500 uCi) will be re-injected into the participant followed by brain PET/MRI at 24-48 hours after injection. Participants will be asked to have a second brain imaging study 3-6 days after this injection, but this second imaging study is optional.
15879614|NCT03807960|Other|written form|The written form which include PCA usage information.
15879615|NCT03807960|Other|video|The video about PCA usage
15879616|NCT03807960|Other|routine care|The routine description about PCA usage
15879617|NCT03807947|Procedure|Radial TAE - Bland embolization with 40-100 Microparticles|TAE - Bland embolization with 40-100 Microparticles performed via left transradial access
15879618|NCT03807947|Procedure|Transfemoral TAE - Bland embolization with 40-100 Microparticles|TAE - Bland embolization with 40-100 Microparticles performed via right transfemoral access
15879649|NCT03807700|Drug|Experimental Denture Adhesive|In this arm, participants will apply the experimental adhesive on their dentures once per day when the denture is placed in mouth.
15879835|NCT03806322|Other|Intermittent Pneumatic Compression|The group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and intermittent pneumatic compression.
15879619|NCT03807934|Other|Stimulation via Soterix Medical or Neuroelectrics noninvasive brain stimulation systems|Active (at or below 2mA) versus sham (at or below 0.5mA) stimulation targeting brain regions engaged during verbal and/or spatial perceptual and cognitive processing. Brain stimulation devices are not currently regulated by the United States Food and Drug Administration. Local IRB has determined the devices to be non-significant risk (NSR) devices via abbreviated investigational device exemption (IDE) procedure.
15879620|NCT03807921|Drug|Warfarin|Oral anticoagulation
15879621|NCT03807921|Drug|Aspirin|Antiplatelet treatment
15879622|NCT03807908|Other|Tape|"The patient will be placed into maximal flexion of the lumbar spine prior to the tape being applied. The vertical strips will be applied on either side of spine, on the erector muscle group; from the lower PSIS with and end around the twelfth rib. The third strip of tape will be applied horizontally to superior to the posterior superior iliac spines (PSIS) and extend over the 2 vertical strips of tape. The tape will be gently rubbed to activate the adhesive.
~Five to 7 days later, one of the investigators will follow up with the subjects over the phone and administer a questionnaire that will assess their experience with the tape as well as the outcome measures (numeric rating scale and Oswestry Disability Index)."
15879623|NCT03807908|Other|Sham Tape|"One strip of tape will be applied horizontally to the thoracolumbar junction (at the level of the lower rib cage over the T12-L1 spinous processes) with no tape-tension. The tape will be gently rubbed to activate the adhesive.
~Five to 7 days later, one of the investigators will follow up with the subjects over the phone and administer a questionnaire that will assess their experience with the tape as well as the outcome measures (numeric rating scale and Oswestry Disability Index)."
15879624|NCT03807895|Behavioral|REBT Career Intervention|Eight sessions of regular career intervention with rational emotive behavioral therapy (REBT) methods.
15879625|NCT03807895|Behavioral|Regular Career Intervention|Eight sessions of regular career intervention.
15879626|NCT03807882|Other|Bilateral M-ECT|Following acute treatment with bilateral ECT of 6 sessions over a period of two weeks, Bilateral M-ECT will be administered at a frequency of 1 session/week for one month, then 1 session / 2 weeks for 2 months and then 1 session/month for next 3 months.
15879627|NCT03807882|Drug|Clozapine|Clozapine will be given in accordance with Maudsley guideline: 12.5 mg on the first day, followed by 12.5mg twice daily on the second day, followed by 25mg twice daily for next two days and then increment of 25mg every two days till the target dose of 250-400 mg per day in two divided doses as per tolerability of the patients
15879628|NCT03807869|Procedure|combined glaucoma surgery|phacoemulsification of cataract and I-stent by-pass implantation
15879629|NCT03807856|Drug|Dabigatran Etexilate Mesylate|Dabigatran 150mg BID for 3 days
15879630|NCT03807856|Other|Standard of Care|Daily vital signs, lab work and one outpatient clinic visit
15879631|NCT03807843|Biological|MV-CHIK|Liquid frozen, life attenuated, measles vectored Chikungunya vaccine; 5E+05 TCID50 (+/- 0.5 log) per dose.
15879632|NCT03807843|Other|Placebo|Sterile physiological saline for injection
15879633|NCT03807830|Procedure|Electrocochlography|Intra-operative ECochG recording via the implant, post operative ECochG measurements. Impedances measured over time.
15879634|NCT03807817|Other|Alcohol administration|Amount of alcohol to be administered.
15879635|NCT03807817|Other|Placebo|Placebo Alcohol
15879636|NCT03807817|Other|No Alcohol|No Alcohol
15879637|NCT03807804|Biological|HLCM051|HLCM051 is the stem cell product that can be mass-produced, being derived from adult adhesive stem cells that were taken from bone marrow of healthy unrelated donors from whom the informed consent was obtained, and proliferated ex vivo.
15879638|NCT03807791|Procedure|Blood sample|"A blood sample will be taken by the nurse of our unit within a week after their consent. It consists as a simple blood sample and it will be taken during the normal analysis planed by the chief of the service in order to avoid to collect two different samples.
~The measurement method will use equipment from the Lyon Sud hospital laboratory. The samples need a pre-treatment in the 3 hours after taking the blood to avoid the oxidation of vitamin C and a result lower than expected."
15879639|NCT03807778|Drug|TAK-788|TAK-788 capsule
15879640|NCT03807765|Drug|Nivolumab|480 mg intravenous Nivolumab administered every 4 weeks.
15879641|NCT03807765|Radiation|Stereotactic Radiosurgery|"Patients will receive single session SRS to intact brain metastases and post-operative cavities.
~A linear accelerator (LINAC)-based frameless delivery system will be used to deliver the stereotactic radiation. The lesion will be defined using gadolinium enhanced MRI with 1 mm slices for treatment planning purposes prior to the delivery of radiation. The MRI image will be co-registered and fused with CT imaging. Doses will be prescribed to ensure coverage of at least 95% of the planning target volume (PTV) with the prescription dose. Treatments will be delivered using dynamic conformal arcs or intensity modulated radiotherapy."
15879642|NCT03807752|Dietary Supplement|MPH_active|One daily intake at breakfast of supplementary marine protein hydrolysate (MPH), a dosage of X mg, duration 8 weeks. The form is powder, flavored with lemon, and to be mixed with 100 ml water. Random sequence of arms.
15879643|NCT03807752|Dietary Supplement|MPH_placebo|One daily intake at breakfast of supplementary placebo, a dosage of X mg, duration 8 weeks. The form is powder, flavored with lemon, and to be mixed with 100 ml water.
15879644|NCT03807739|Drug|GDC-0134 F09 Formulation|Participants will receive a single oral dose of GDC-0134 reference capsule F09.
15879645|NCT03807739|Drug|GDC-0134 F15 Formulation|Participants will receive a single oral dose of GDC-0134 prototype capsule F15.
15879646|NCT03807739|Drug|GDC-0134 F16 Formulation|Participants will receive a single oral dose of GDC-0134 prototype capsule F16.
15879647|NCT03807726|Behavioral|Simulation breastfeeding education|The integrated interventions are consisted of 1) four sessions of simulation breastfeeding education to build up the participants' performance accomplishment and vicarious learning including breastfeeding knowledge, skill, and self-efficacy; 2) two sessions of breastfeeding mindfulness training to equip women and their partners with stress reduction skills for their emotional arousal during breastfeeding; 3) a series of postpartum professional support to offer verbal persuasion in enhancing their breastfeeding skills and levels of self-efficacy.
15879648|NCT03807713|Device|Minimally Invasive Ponto Surgery|Minimally Invasive Ponto surgery is used for hearing rehabilitation using Ponto Wide Implants in patients indicated and counselled for Bone Anchored Hearing Systems.
15879673|NCT03807479|Drug|Ponatinib|2 film-coated tablets à 15mg for oral administration on a daily basis
15879650|NCT03807674|Procedure|Coronal pulpotomy|Coronal pulpotomy was performed with a sterile high-speed round bur under water coolant. Pulp vitality was confirmed by the presence of bleeding pulp tissue from all of the canal orifices. Hemostasis was achieved through the application of a pellet moistened with 2.5% NaOCl for two minutes and was repeated as needed. Calcium-silicate based material was prepared ac-cording to the manufacturer's instructions and gently placed over the pulp to fill the entire cavity.
15879651|NCT03807661|Procedure|Percutaneous deep vein arterialization|Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
15879652|NCT03807661|Device|LimFlow System|Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
15879653|NCT03807648|Other|Data Inclusion|Patients in this group will be included in the project
15879654|NCT03807635|Device|ergoLance safety lancet|The ergoLance contact activated safety lancets type 450 are sterile, single-use safety lancets designed for the sampling of capillary blood from the fingertip of patients.
15879655|NCT03807635|Device|Acti-Lance safety lancet|The Acti-Lance safety lancet type 610 is a sterile, single use device used to carry out skin punctures for the purpose of collecting capillary blood samples.
15879656|NCT03807622|Device|EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System|EV1000NI Clinical Platform: Noninvasive Hemodynamic Monitoring utilizing ClearSight System
15879657|NCT03807609|Other|CON . control condition without exercise / rest condition|Control condition without exercise / rest condition. The adolescents will be asked to remain quiet and at rest during the morning and will receive an ad libitum meal at lunch and dinner times. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.
15879658|NCT03807609|Other|EX -30. Condition with an acute exercise set 30 minutes before lunch|The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling), 30 minutes before lunch. Lunch will be served ad libitum as well as diner. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.
15879659|NCT03807609|Other|EX-180. condition with an acute exercise set 180 minutes before lunch|The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling), 30 minutes before lunch. Lunch will be served ad libitum as well as diner. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.
15879660|NCT03807596|Procedure|Periodontal treatment with Hyaluronic acid associated with SRP|In addition to SRP, patients in the test group received adjunct subgingival application of hyaluronic acid in all selected periodontal pockets.
15879661|NCT03807596|Procedure|Scaling & root planning alone|Patients received full-mouth supra- & sub-gingival SRP with the use of ultrasonic device & periodontal universal & Gracey curettes under local anesthesia.
15879662|NCT03807583|Drug|Aminoven 10%|"After randomization to the visit Day 60, two months after patients inclusion (Visit Day 0) and one month after clinical examination (Visit Day 30), patients will be assigned to a group:
~group A: RENORAL® product
~group B: AMINOVEN® 10% product
~group C: control group (without intradialytic supplementation)
~Patients will consume the products and will be followed for 3 months, one visit per month (Day 90, Day 120, Day 150). Protocol visits are included in the patient's course of care."
15879663|NCT03807583|Dietary Supplement|RENORAL|"After randomization to the visit Day 60, two months after patients inclusion (Visit Day 0) and one month after clinical examination (Visit Day 30), patients will be assigned to a group:
~group A: RENORAL® product
~group B: AMINOVEN® 10% product
~group C: control group (without intradialytic supplementation)
~Patients will consume the products and will be followed for 3 months, one visit per month ( V3, V4, V5). Protocol visits are included in the patient's course of care."
15879664|NCT03807570|Dietary Supplement|Morus Alba L. Extract|Morus Alba L. Extract 30 ml/day for 12 weeks.
15879665|NCT03807570|Dietary Supplement|Placebo|Placebo 30 ml/day for 12 weeks.
15879666|NCT03807557|Other|Robotic Constraint-induced movement therapy|"i.Robotic repetitive task-specific training followed by task-oriented practice: during each session, participants first receive 60 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 30 minutes of functional practice using shaping technique.
~ii.Restraint of the unaffected limb: Patients will wear a mitt to restrict the unaffected hand during training at clinic for 0.5 hours of functional practice each session, 3 sessions per week for 8 weeks.
~iii. Transfer package: The transfer package aims at transferring the therapy gains to the participant's real world by use of a set of behavioral techniques. This is intended to have the participant responsible for adhering to the treatment requirements and encourage active engagement in the functional practice outside of the clinic setting. The participants will be given appropriated home assignment practicing daily activities outside of the clinic."
15879667|NCT03807557|Other|conventional UE rehabilitation training|focusing on UE training and including neuro-developmental techniques(Bobath, 1990), trunk-arm control (ie, practice UE tasks during standing), weight bearing by the affected arm, fine motor tasks practice, functional task practice, and practice on compensatory strategies for daily activities.
15879668|NCT03807544|Device|TENS|Transcutaneous electrical nerve stimulation
15879669|NCT03807531|Device|Temporary Spur Stent System|Participating subjects that meet inclusion and exclusion criteria will undergo treatment of infrapopliteal occlusions and stenoses with the Temporary Spur Stent System according to protocol guidelines
15879670|NCT03807518|Behavioral|Standard Exercise Program|Standard Exercise Program- Participants will be invited to take part in a structured home, supervised, or both, exercise program while undergoing neo adjuvant therapy and for a six week period when deemed fit post surgery.
15879671|NCT03807505|Procedure|Interscalene brachial plexus nerve block|An interscalene brachial plexus nerve block (single shot or catheter, depending on surgical procedure) will be placed under ultrasound guidance and all patients will receive 10cc 0.5% ropivacaine during block placement. Patients with a nerve catheter will receive a bolus of 5cc 0.5% ropivicaine postoperatively, on arrival to the recovery unit.
15879672|NCT03807505|Procedure|Erector spinae plane block|An erector spinae plane block (single shot or catheter, depending on surgical procedure) will be placed under ultrasound guidance and all patients will receive 10cc 0.5% ropivacaine during block placement. Patients with a nerve catheter will receive a bolus of 5cc 0.5% ropivicaine postoperatively, on arrival to the recovery unit.
15879710|NCT03807206|Behavioral|Questionnaire|Patient questionnaire
15879674|NCT03807466|Behavioral|Dynamic/Interactive vs. Static/Paginated Report|Evaluate whether a stand-alone interactive audit-and-feedback report highlighting antibiotic prescribing can lead to greater reductions in antibiotic use, than a report embedded in a broader static feedback system
15879675|NCT03807466|Behavioral|LTC Physicians Enrolled vs. Not Enrolled in Reports|Evaluate whether being provided an audit-and-feedback report (regardless of dynamic or static) can lead to greater reductions in antibiotic use, than those who do not receive either report
15879676|NCT03807453|Other|Microbiota|The scalp microbiota
15879677|NCT03807440|Drug|Empagliflozin|Empagliflozin
15879678|NCT03807440|Drug|Sodium Glucose Transporter 2 inhibitor|Sodium Glucose Transporter 2 inhibitor
15879679|NCT03807440|Drug|Dipeptidyl-peptidase 4 inhibitor|Dipeptidyl-peptidase 4 inhibitor
15879680|NCT03807440|Drug|Glucagon-like peptide 1 agonist|Glucagon-like peptide 1 agonist
15879681|NCT03807427|Behavioral|READY-Nepal|Regulating Emotions through Adapted Dialectical behavior skills for Youth in Nepal (READY-Nepal) is a brief (10-session), emotion-focused intervention targeting prevention and reduction of trans diagnostic problems related to emotion regulation. The culturally adapted program is divided into 5 modules, and includes both didactic and experiential instruction in skills related to mindfulness, stress tolerance, emotional awareness and regulation, validation of self and others, and mastery of interpersonal relationships.
15879682|NCT03807414|Device|oXiris|Every center will prescribe EBPT with oXiris in accordance with local practice and local levels of expertise. No variation in treatment prescription and/or treatment solutions will derive from participation in this prospective observational study. Nonetheless, every setting parameter will be recorded in the web-based registry and analyzed a-posteriori to reveal a potential correlation with the patient outcomes.
15879683|NCT03807401|Behavioral|Prismatic goggles|Goggles inducing a lateral displacement of the virtual field of ten degrees. Participants will be asked to wear those goggles during adaptation session and to perform pointing movement toward visual target.
15879684|NCT03807401|Behavioral|Virtual reality device|The lateral displacement will be simulated thanks to a virtual reality environment. Participants will wear an Oculus Rift instead of the prismatic goggles and will perform pointing movement as well.
15879685|NCT03807401|Behavioral|Prismatic goggles|Goggles inducing a lateral displacement of the virtual field of ten degrees. Participants will be asked to wear those goggles during adaptation session and to mentally perform pointing movement toward visual target. There will be no concurrent movement execution.
15879686|NCT03807388|Device|ReMindCare Intervention Group|Daily and weekly assessments of patient´s health status, and generation of alarms related to these answers. Moreover, patients can contact clinicians by an urgent consultation tab.
15879687|NCT03807388|Other|Treatment as Usual|Psychiatric usual treatment at First Episode of Psychosis Unit at Clinical Hospital of Valencia, Spain.
15879688|NCT03807375|Other|CPAP preoxygenation|During preoxygenation, the ventilator device will be placed in spontaneous mode and set as CPAP: 5 cmH2O.
15879689|NCT03807362|Drug|CC-11050|CC-11050 is a novel anti-inflammatory compound with potential to treat a variety of chronic inflammatory conditions.
15879690|NCT03807349|Device|N-Force Screws Augmented with N-Force Blue|N-Force Fixation System 7.3 mm (Non-fenestrated/fenestrated) applied with washers; N-Force Blue (Bone Substitute Material)
15879691|NCT03807336|Behavioral|Emotion-Focused Skills Training for Parents - Experiential|The intervention consists of a 2-day work shop given in a group format, in addition to 6 hours of parent supervision within 6 weeks after the work shop.
15879692|NCT03807336|Behavioral|Emotion-Focused Skills Training for Parents - Psychoeducational|The intervention consists of a 2-day work shop given in a group format, in addition to 6 hours of parent supervision within 6 weeks after the work shop.
15879693|NCT03807323|Behavioral|Lifestyle counselling and exercise|"The program consists of:
~Instructor-led training twice a week,
~One individual nutritionist counselling session of followed by three group based two-hour nutritionist counselling focusing on practical food purchase and preparation and
~Three two-hour psychologist-led group counselling sessions based on implementation intentions theory and practical help to make if-then plans focusing on changing food and activity habits."
15879694|NCT03807310|Dietary Supplement|Targeted nutrient supplementation (Long-drink)|Once daily for at least 12 months
15879695|NCT03807310|Dietary Supplement|Placebo supplement|Once daily for at least 12 months
15879696|NCT03807310|Behavioral|Counselling|Counselling on healthy lifestyle (in particular physical activity, smoking cessation) and weight management by motivational interviewing
15879697|NCT03807297|Drug|Injection dexmedetomidine|alpha 2 a agonist used for sedation, analgesia
15879698|NCT03807297|Drug|Injection, Propofol, 10 Mg|non barbiturate type of intravenous anaesthetic drug
15879699|NCT03807297|Other|sevoflurane|inhalational anaesthetic agent
15879700|NCT03807297|Other|nitrous oxide|inhalational anaesthetic agent
15879701|NCT03807284|Behavioral|A group psychosocial course|A 2 hour, weekly group psychosocial therapy RCAS course that aims to improve confidence and help adjustment after a stroke.
15879702|NCT03807271|Device|Calculated and graphically produced depth of anesthesia (Smart Pilot® View)|Smart Pilot® View is a device integrated in the ventilator used under general anesthesia. The depth of anesthesia is calculated based on age, weight, height and the medication given - both volatiles and intravenous. The device does not control the supply of medication directly, but provides an estimate of anesthesia depth that can help the anesthesia team to control the supply of anesthetic agents under general anesthesia, ie indirectly.
15879703|NCT03807258|Other|Transcranial magnetic stimulation (TMS)|Evaluations by TMS
15879704|NCT03807245|Biological|GBS-NN/NN2 with Alhydrogel® 25|GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart
15879705|NCT03807245|Biological|Placebo GBS-NN/NN2 with Alhydrogel® 25|GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart
15879706|NCT03807245|Biological|Placebo GBS-NN/NN2 with Alhydrogel® 50|GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart
15879707|NCT03807245|Biological|GBS-NN/NN2 with Alhydrogel® 50|GBS-NN/NN2 with Alhydrogel® vaccine will administered to subjects intramuscular 2 times with 4 weeks apart
15879708|NCT03807219|Dietary Supplement|Magnox Comfort|Magnox Comfort (Magnesium (226 mg in equivalent), Vitamin E - 45 mg, Vitamin B6 - 2 mg.).
15879709|NCT03807219|Other|Placebo|placebo
15879711|NCT03807193|Behavioral|Self-selected treatment|The participants will select their own treatment material with the help of a written manual. The interventions possible to choose are all interventions used in standard cognitive behavior therapy for anxiety and depression.
15879712|NCT03807193|Behavioral|Predetermined treatment|The participants will be given a treatment program designed to address worry and generalized anxiety disorder. The program are based on newer forms of cognitive behavior therapy and include mindfulness and acceptance.
15879713|NCT03807193|Behavioral|Weekly support|The participants will have scheduled weekly support, once a week, during the treatment. The support till be delivered by students in clinical psychology.
15879714|NCT03807193|Behavioral|Support on demand|The participants will have support if and when they ask for it by themselves. If asked for the support will be delivered by students in clinical psychology.
15879715|NCT03807180|Other|Tai Chi (exercise)|Tai Chi exercise method, which is composed of combination of physical exercise and relaxation techniques for patients with rheumatic diseases.
15879716|NCT03807167|Other|Mattis Dementia Rating Scale|This scale was developed to assess the cognitive status of patients with neurodegenerative diseases. There are 37 items that are presented in a fixed order and grouped into five sub-scales: attention, initiation, construction, conceptualization and memory. Patients and healthy subjects with a score below 125 are not included because of major cognitive impairment.
15879717|NCT03807167|Other|Unified Parkinson 's Disease Rating Scale-III|This scale is used to rate the severity of extra-pyramidal symptoms (akinesia, rigidity and tremors). These symptoms may be the cause of reduction of motor activity apart from any reduction in motivation, they onstitute a confounding factor that it should be controlled.
15879718|NCT03807167|Other|Mini Neuropsychiatric Investigation|This is a structured interview that allows rapid screening in about 20 minutes of troubles Psychiatric. It is based on short questions to which the patient must answer yes or no and on a decision tree. Patients must validate clinical diagnoses of depression.
15879719|NCT03807167|Other|Montgomery and Asberg depression Rating Scale|This scale is composed of 10 items from 0 to 6 from a semi-structured interview, to obtain a total depression score of 0 to 60 (0 no depression, 60 maximum intensity of depression).
15879720|NCT03807167|Other|Clinical Global Impression|heterosexual assessment that rates the severity of symptoms suicidal and changes in suicidal symptoms. Any subject with a score greater than 4 is not included.
15879721|NCT03807167|Other|Apathy diagnostic criteria|The clinical criteria make it possible to make a diagnosis of apathy with a functional repercussion. It is based on a lack of motivation felt by the patient, causing a functional or social impact that is not the consequence of a disturbance of consciousness or a disability engine. The cognitive, emotional and behavioral dimensions are affected.
15879722|NCT03807167|Other|walking speed test|The patient is timed to walk 10m. A speed <1m / sec is a criterion exclusion because it shows severe sarcopenia and constitutes a bias.
15879723|NCT03807167|Other|accelerometer presentation|accelerometer presentation and pose
15879724|NCT03807167|Other|data acquisition from the accelerometer|withdrawal of the accelerometer and data acquisition from the accelerometer
15879725|NCT03807167|Other|Apathy Evaluation Scale,|clinician version and near-helping version. It's a hetero rating scale from an interview semi structured by a trained clinician. It assesses cognitive, emotional and behavioral apathy than three items of various apathy. The total score ranges from 18 (total absence of apathy) to 72.
15879726|NCT03807167|Other|fatigue Visual Analog Scale|To date, there is no valid fatigue scale in the depression of the elderly subject, a fortiori in French. The fatigue scale in adult depression includes has been validated with an EVA (Visual Analogue Scale) (38). We therefore propose to use this type of evaluation to control this aspect.
15879727|NCT03807167|Other|executive function|"Modified Card Sorting Test MCST(Modified Card Sorting Test) (Wisconsin Test): This test assesses conceptualization, attention and mental flexibility using a deck of cards.
~Trail Making Test (TMT): This test is used to assess mental flexibility.
~Fluences verbal: This test tests the capacities of setting up search strategies in memory semantics and oral language.
~Stroop Paradigm: This test is used to evaluate the resistance to interference, ie the patient's ability to inhibit some over-learned and automated responses."
15879728|NCT03807167|Other|MRI|An MRI lasting 30 minutes is programmed
15879729|NCT03807167|Other|Apathy Motivation Index|"This is a self-questionnaire of 18 items, each side on a 5-level Likert scale (0: not everything at 4: very often). It differentiates between behavioral apathy and social apathy.
~Emotional."
15879730|NCT03807154|Behavioral|ICBT|A nine week long ICBT-programme with therapist guidance. Based on cognitive and behavioral techniques that have been tailored to address loneliness.
15879731|NCT03807154|Behavioral|IPT|A nine week long internet-based IPT-programme with therapist guidance. Contains three distinct phases: assessment phase (three weeks), focus phase (five weeks, during which the participants will choose from one of four primary problem areas during the three latter weeks), and end phase (one week).
15879732|NCT03807141|Other|Modified Atkins diet|This is a modified version of the ketogenic diet where-in carbohydrates are restricted without any protein or calorie restriction.
15879733|NCT03807128|Other|No interventional study|No interventional study
15879734|NCT03807115|Other|Implementation of stroke mobility guidelines|Delivery of weekly online educational capsules on 4 evidence-based stroke recommendations (motor imagery/mental practice, rhythmic auditory stimulation gait therapy, task-oriented training including fitness and mobility exercises, and aerobic training) plus feedback on participant's awareness, agreement, satisfaction with, and perceived value of the content, perceived implementation success and facilitators and barriers encountered.
15879735|NCT03807102|Biological|Tumor Vaccine|NeoAntigen Tumor Vaccine (5 injections for each 3 days and then 1 injection for each 3 months till recurrence or up to 2 years).
15879736|NCT03807089|Device|Conventional Pediatric Colonoscope|
15879737|NCT03807089|Device|Short-Turn Radius Colonoscope|
15879738|NCT03807076|Other|GIP-A|GIP-A
15879739|NCT03807076|Other|Placebo|Placebo
15879740|NCT03807063|Biological|Rivogenlecleucel|Given IV
15879741|NCT03807063|Drug|Rimiducid|Given IV
15879742|NCT03807050|Dietary Supplement|Astaxanthin|Capsules containing astaxanthin derived from the yeast Phaffia rhodozyma .
15879743|NCT03807037|Dietary Supplement|Tocotrienols|Mixed tocotrienols (derived from palm oil) to be orally administered at 200mg (1 capsule) twice daily, to achieve dosage of 400mg/day
15879745|NCT03807024|Diagnostic Test|Bladder diary|3-day bladder diary: The classification of OAB-wet or OAB-dry is based on the record of the three-day bladder diary of each patient. The diagnosis of OAB in each patient was based on the presence of at least one episode of urgency in her three-day bladder diary and with the absence of stress urinary incontinence. The presence of at least one episode of urgency associated incontinence was defined to be OAB-wet, otherwise, OAB-dry
15879746|NCT03807011|Drug|fentanyl group|fentanyl 2 μg/kg
15879747|NCT03807011|Drug|remifentanil group|remifentanil 0.2 μg/kg/min
15879748|NCT03806998|Dietary Supplement|Ketoacids|Provision of 1 Tablet containing 630 mg of ketoacids every 5 kg of body weight during 16 weeks
15879749|NCT03806998|Dietary Supplement|Placebo|Provision of placebo capsules similar to active supplement
15879750|NCT03806985|Drug|Placebo oral capsule|microcrystalline cellulose capsule
15879751|NCT03806985|Drug|Low Dose Psilocybin|0.0143 mg/kg psilocybin capsule (weight-based option) or 1 mg psilocybin capsule (fixed-dose option)
15879752|NCT03806985|Drug|High Dose Psilocybin|0.143 mg/kg psilocybin capsule (weight-based option) or 10 mg psilocybin capsule (fixed-dose option)
15879753|NCT03806959|Other|Pan Capsule and colonoscopy in patients with IBS|Every patient will have both Pan Capsule and colonoscopy examinations Descriptive study only Usual biological tests (CBC, CRP, TSH, anti-transglutaminase antibodies) and measurement of fecal calprotectin.
15879754|NCT03806946|Diagnostic Test|electroencephalography|diagnosis epileptic discharge
15879755|NCT03806946|Diagnostic Test|psychometric scales to diagnosis psychiatric disorders|to diagnosis intellectual disability, attention deficit hyperactivity disorder ,epilepsy,autism and other mental illness.
15879756|NCT03806946|Other|psychometric scales for assesment socioeconomic and behaviour problems|to assessment other behavioural comorbidity as aggression ,mood changes,etc and help in identify function impairment, social and economic burden
15879757|NCT03806933|Drug|NT 201|Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
15879758|NCT03806920|Dietary Supplement|Intervention A|
15879759|NCT03806920|Dietary Supplement|Intervention B|
15879760|NCT03806920|Dietary Supplement|Intervention C|
15879761|NCT03806920|Dietary Supplement|Intervention D|
15879762|NCT03806907|Radiation|Computed tomography lung subtraction iodine mapping|Subtraction of the non-contrast CT from the contrast-enhance CTPA produces the CT-LSIM
15879763|NCT03806894|Diagnostic Test|Quantification of platelet aggregation|Platelet aggregation will be determined by vasodilator-stimulated phosphoprotein (VASP) assay
15879764|NCT03806881|Device|reversed glenoid prothesis|All patients will undergo a primary or revision arthroplasty with Glenius according to the routine practice at the investigation site and will be followed at specified visiting moments, during which radiological and clinical data will be gathered.
15879765|NCT03806868|Other|voucher for ordering foods (ONLY omega-3 rich foods)|A voucher will be provided weekly (4 times) for ordering only omega-3 rich foods. Groceries will be delivered to participants' home weekly.
15879766|NCT03806868|Other|voucher for ordering foods in general (any type of foods)|A voucher will be provided weekly (4 times) for ordering any type of food. Groceries will be delivered to participants' home weekly.
15879767|NCT03806855|Diagnostic Test|Bladder diary|3-day bladder diary
15879768|NCT03806842|Device|Easytech group|total shoulder replacement
15879769|NCT03806829|Other|Water|250 ml
15879770|NCT03806829|Other|Red Wine|250 ml
15879771|NCT03806829|Other|Green Tea|250 ml
15879772|NCT03806829|Other|Orange Juice|250 ml
15879773|NCT03806816|Dietary Supplement|Melatonin|5 daily enteral doses of melatonin 10 mg/kg. (=2 ml/kg)
15879774|NCT03806816|Other|PLACEBO group|5 daily enteral doses of placebo 2 ml/kg
15879777|NCT03806790|Drug|LEO 90100 foam|Once daily topical application of foam from a can to psoriasis lesions. Dose depends on size of lesion.
15879778|NCT03806790|Drug|Dovobet® ointment|Once daily topical application of ointment from a tube to psoriasis lesions. Dose depends on size of lesion.
15879779|NCT03806777|Drug|Dexmedetomidine|Highly selective alpha-2 adrenergic agonist with sedative properties.
15879780|NCT03806764|Diagnostic Test|Blood sampling|Blood sampling from prospective study participants will be taken for immune functions measurements
15879781|NCT03806751|Drug|[O-15]Water|All study participants with undergo brain imaging with [O-15]water-PET/MRI without and with administration of the carbonic anhydrase inhibitor acetazolamide. The PET tracer will be used to measure regional cerebral perfusion, and the administration of acetazolamide will lead to increased cerebral perfusion compared to baseline cerebral perfusion.
15879782|NCT03806751|Drug|Acetazolamide|The administration of acetazolamide will lead to increased cerebral perfusion compared to baseline cerebral perfusion.
15879783|NCT03806738|Other|Intervention-specific Carevive questionnaire|includes standard of care questions with additional decision-making questions
15879784|NCT03806738|Other|Standard of Care questionnaire|includes the standard of care questions that are already in place for Carevive questionnaires
15879785|NCT03806725|Diagnostic Test|Intravenous administration of iodinated contrast medium for coronary CT angiography|Administration of iodinated contrast medium for coronary CT angiography
15879786|NCT03806712|Other|multi method questionary (developped by De Rosa, in 1995 and 2014)|questions from an association network according to the subject and the grounded theorise (Glasser and Strauss)
15879787|NCT03806699|Biological|Placebo|Sterile normal saline
15879788|NCT03806699|Biological|ID93+GLA-SE|ID93 is a recombinant protein antigen comprising 4 antigens from Mycobacterium tuberculosis (Mtb). The adjuvant GLA-SE is a TLR4 agonist in a stable oil-in-water emulsion.
15879789|NCT03806686|Biological|Placebo|Sterile normal saline
15879790|NCT03806686|Biological|ID93+GLA-SE|ID93 is a recombinant protein antigen comprising 4 antigens from Mycobacterium tuberculosis (Mtb). The adjuvant GLA-SE is a TLR4 agonist in a stable oil-in-water emulsion.
15879791|NCT03806673|Drug|marcaine|epidural block
15879792|NCT03806621|Procedure|Rotational Atherectomy|Patients with severe calcified lesions will receive rotational atherectomy during index PCI
15879793|NCT03806608|Procedure|Crestal|Subjects will be included with the absence of 2-4 teeth in the posterior region of the maxilla or mandibular. Twenty patients will be recruited. Two implant placement depths, equicrestal and subcrestal, were randomly assigned to two sites of each patient with a predefined randomization tables (one crestal implant and one subcrestal implant).
15879794|NCT03806608|Procedure|Subcrestal|Subjects will be included with the absence of 2-4 teeth in the posterior region of the maxilla or mandibular. Twenty patients will be recruited. Two implant placement depths, equicrestal and subcrestal, were randomly assigned to two sites of each patient with a predefined randomization tables (one crestal implant and one subcrestal implant).
15879795|NCT03806595|Drug|Lidocaine 2% Injectable Solution|The Barre method of intranasal administration will be used to instil 1mL of lidocaine 2% in either the nostril ipsilateral to the headache or 1ml in each nostril in cases of bilateral headache.
15879796|NCT03806595|Drug|Normal Saline Flush, 0.9% Injectable Solution|The Barre method of intranasal administration will be used to instil 1mL of saline 0.9% in either the nostril ipsilateral to the headache or 1ml in each nostril in cases of bilateral headache.
15879797|NCT03806582|Drug|Norepinephrine|intervention with norepinephrine to reach a MAP of 85 mmHg
15879798|NCT03806569|Behavioral|MAC-cbt group treatment for adult ADHD|Psychotherapeutic intervention to treat adult patients with ADHD to be mindful, accept the symptoms and disturbances and commit with the situation or the possibility to change.
15879799|NCT03806569|Behavioral|Jacobson|Relaxation treatment in technique of Jacobson in 8 sessions
15879800|NCT03806556|Drug|Tranexamic Acid|IV medication administered after patient meets inclusion/exclusion criteria
15879801|NCT03806556|Drug|Normal saline|IV medication administered after patient meets inclusion/exclusion criteria
15879802|NCT03806543|Drug|Vancomycin|adult patients treated with intravenous vancomycin in intensive care unit
15879803|NCT03806530|Drug|Gabapentin|100 mg capsule
15879804|NCT03806530|Drug|Ropinirole|0.50 mg capsule
15879805|NCT03806530|Drug|Placebo Gabapentin|Placebo capsule
15879806|NCT03806530|Drug|Placebo Ropinirole|Placebo capsule
15879807|NCT03806504|Other|PEEP|performing 35 cm/H2O PEEP and 2-3 ml/kg tidal volume
15879808|NCT03806504|Other|control group|performing 6 cm/H2O PEEP and 6-8 ml/kg tidal volume
15879809|NCT03806491|Behavioral|Cognitive Behavioral Therapy for Insomnia|Study therapists will follow the 2014 CBT-I in Veterans manual developed by leading researchers in the behavioral sleep medicine field. Intervention components include (1) sleep hygiene: limiting naps; avoiding caffeine, tobacco, alcohol, and rich/heavy foods before bedtime; exercising; establishing a bedtime routine; and creating a comfortable sleep environment; (2) sleep restriction: limiting time in bed in order to improve sleep efficiency, or the percentage of time in bed that is actually spent sleeping; time in bed will be titrated each week based on sleep efficiency; (3) stimulus control: strengthening association between bedroom and sleep to decrease conditioned arousal; (4) relaxation: diaphragmatic breathing, progressive muscle relaxation, and visual imagery to reduce arousal; and (5) cognitive therapy: identifying and challenging thoughts that interfere with sleep.
15879810|NCT03806491|Behavioral|Sleep Hygiene|Study therapists will review a one-page handout on sleep hygiene with all participants. This is the only intervention that participants assigned to the sleep hygiene condition will receive. This is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
15879811|NCT03806491|Behavioral|Alcohol Use Disorder Treatment as Usual|CBT-based groups for Alcohol Use Disorder will focus on the acquisition of skills needed to cope effectively with urges and cravings to drink and manage high-risk situations.
15879812|NCT03806478|Drug|APH-1105|The investigational drug product, APH-1105 is a sterile, pyrogen-free lyophilized powder intended for intranasal administration.
15879813|NCT03806478|Other|Placebo|The placebo is a sterile, pyrogen free lyophilized powder identical in appearance to the experimental drug
15879814|NCT03806465|Other|Feasibility survey|A survey questionnaire will be administered at each household. At the baseline household survey, each child aged less than 5 years will be tested for malaria using a rapid malaria test.
15879815|NCT03806465|Other|Sentinel hospital surveillance|Cerebrospinal samples will be collected from all children hospitalised and suspected of having meningitis.
15879816|NCT03806465|Other|Community mortality surveillance|A verbal autopsy will be performed
15879817|NCT03806452|Drug|Hydroxycarbamide|Hydroxycarbamide tablets of 100 and 1000 mg
15879818|NCT03806452|Drug|Placebo Oral Tablet|Placebo tablets of 100 and 1000 mg to mimic hydroxycarbamide tablets
15879819|NCT03806439|Other|Radical cystectomy.|Adult patients undergoing radical cystectomy.
15879820|NCT03806426|Drug|Eicosapentaenoic acid free fatty acid (EPA-FFA)|500mg capsule, two 500mg capsules to be taken twice daily for 24 months
15879821|NCT03806426|Drug|Placebo|500mg capsule, two 500mg capsules to be taken twice daily for 24 months
15879822|NCT03806413|Other|Open heart surgery|The study will be done on patients undergoing open heart surgery in Alexandria University hospitals from January 5th 2019 till January 4th 2020. The 6-item Cognitive Impairment Test (6CIT) and SPMSQ questionnaire will be used. SPMSQ will be done preoperative and daily for 3 days postoperative, at day 7. Phone call for SPMSQ will be done 3, 6 9 and 12 months after surgery.
15879823|NCT03806387|Drug|Alemtuzumab|Alemtuzumab will be given two times, separated by 1 year.
15879824|NCT03806374|Drug|Ketamine|ketamine
15879825|NCT03806374|Drug|Propofol|propofol
15879826|NCT03806374|Drug|Fentanyl|fentanyl
15879827|NCT03806374|Drug|Cisatracurium|cisatracurium
15879828|NCT03806374|Drug|Lidocaine|lidocaine
15879831|NCT03806348|Procedure|Resuturing|Early reconstruction of the perineal body after wound dehiscence within two weeks of delivery.
15879832|NCT03806335|Other|Infiltration|The infiltration will be performed by the anesthetist using a 25G- 3.5cm curved needle. A total of 2.5 ml of local anesthetic mixture will be used for each tonsil. The mixture will contain: 10 ml xylocaine 2% an d10 ml bupivacaine 0.5%
15879833|NCT03806335|Other|Placebo|Patients will receive 2.5 ml normal saline in each tonsil
15879834|NCT03806335|Other|General anesthesia|All patients will receive general anesthesia prior to infiltration
15879836|NCT03806322|Other|Cold-pack|The group received ultrasound, transcutaneous electrical nerve stimulation, electrical stimulation, exercise, and cold packs.
15879840|NCT03806296|Other|Increase morning bright light|Participants will wear Re-Timer bright glasses for 30 minutes each morning
15879841|NCT03806296|Other|Decrease evening blue light|Participants will wear tinted glasses that block blue wavelength light for 2 hours before bed
15879842|NCT03806296|Behavioral|Sleep scheduling|Participants will advance their weekday bedtime and maintain their weekday risetime on weekends
15879843|NCT03806296|Behavioral|Monitor sleep, mood, and substance use|Participants will monitor sleep, mood, and substance use via smartphone-based platform and wrist actigraphy
15879844|NCT03806283|Procedure|Omental Biopsy|The surgeon and clinical care team will conduct the c-section to deliver the baby and the placenta as clinically indicated. During the closing procedures, the surgeon will indicate a time for a participating Ob/Gyn physician on the study team to collect the omental bio-specimen. Omentum is frequently excised or removed for clinical reasons during surgical procedures. Omentum has small blood vessels within it that have been used for evaluation of vascular functional changes in research. The investigators wish to isolate one to three vessels of 5 to 7 cm length. The surgeon will then close and the clinical care team will resume their standard of care activities.
15879845|NCT03806270|Drug|Midazolam|Demizolam 15mg/ml ampules, given orally with cherry juice
15879846|NCT03806270|Drug|Hydroxyzine Dihydrochloride|Atarax 2mg/ml syrup, given orally
15879847|NCT03806257|Other|Enhanced Physical Therapy Protocol|A structured physical therapy protocol that requires subject to ambulate more frequently than the standard-of-care patient.
15879848|NCT03806244|Other|Intraoperative acquisition (robotic c-Arm) of images|"Conventional laparoscopic colorectal oncologic resection is performed. During the procedure, the operator will identify previously defined anatomical landmarks, point them with an instrument tracked by the navigation system and the accuracy of the stereotactic navigation system will be calculated by comparing the surgical anatomical point and its correspondent on the images of the navigation platform."
15879849|NCT03806231|Drug|Outpatient Dinoprostone 10mg|Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women randomized to the outpatient cervical ripening group will be administered the drug prior to their induction and discharged after monitoring and physician approval. They will return for their schedule induction.
15879850|NCT03806231|Drug|Inpatient Dinoprostone 10 mg|Dinoprostone (10 mg) is a vaginal insert approved to start and/or continue the ripening of the cervix in pregnant women who are at or near the time of delivery and in whom there is a medical reason for inducing (bringing on) labor. Women who are randomized to the inpatient cervical ripening group will be administered the drug prior to their induction and remain hospitalized.
15879851|NCT03806218|Device|Bipolar RFA|Bipolar RFA in which RF currents flow between two electrodes
15879852|NCT03806218|Device|SM-RFA|Monopolar RFA using multiple electrodes with switching mode
15879853|NCT03806218|Device|Twin internally cooled-wet electrodes|Saline-enhanced twin internally cooled electrodes allow intratumoral injection of a saline solution during the application of the RF current that alters the tissue conductivity
15879854|NCT03806218|Device|Separable clustered electrodes|A separable clustered electrode is similar to a clustered electrode, although it differs from a conventional clustered electrode in that each individual electrode is separable.
15879855|NCT03806205|Other|regular follow-up|we give a regular follow-up and supervision on the study group
15879856|NCT03806192|Behavioral|Telephone-Based Intervention|Attend psychoeducational counseling sessions via telephone
15879857|NCT03806192|Other|Behavioral, Psychological or Informational Intervention|Attend psychoeducational counseling sessions via video teleconference
15879858|NCT03806192|Other|Questionnaire Administration|Ancillary studies
15879859|NCT03806179|Drug|Betalutin|Betalutin 10, 15 MBq/kg; lilotomab 40mg, rituximab 375 mg/m2
15879860|NCT03806166|Other|Shorter Systemic Antibiotics|Reduced duration of post-operative systemic antibiotic therapy
15879861|NCT03806166|Other|Standard treatment|Standard duration of systemic antibiotic treatment
15879862|NCT03806153|Other|Morphokinetic|The embryos will be observed at a fixed time and according to morphological criteria (Alpha Specialist Group in Reproductive Medicine and ESHRE, 2011). and all the films obtained will be analyzed. Embryos will be classified according to morphokinetic criteria (Ciray et al., 2014).
15879863|NCT03806140|Behavioral|text messages|receive about one health-related text message a day for 16 weeks
15879864|NCT03806127|Drug|Vibegron|oral administration
15879865|NCT03806127|Drug|Placebo|oral administration
15879866|NCT03806114|Procedure|Posterior Approach Precautions|These patients will be advised not to bend their leg or trunk more than 90 degrees, avoid crossing the leg or crossing midline, and rotating the leg inwards. Patients will also be instructed to put a pillow in between their legs while sleeping for 6 weeks and to avoid bathing for 6 weeks.
15879867|NCT03806114|Procedure|Anterior Approach Precautions|These patients will be advised to avoid extending the leg back, rotating the leg outwards, and lifting their bottom when lying down after their surgery for 6 weeks.
15879868|NCT03806114|Procedure|No Precautions|For the non-precautions group, there will be no mention of precautions by any providers before, during, and after surgery. No equipment will be given, but a list of self-care equipment will be available for 'comfort' purposes. Patients will be instructed to avoid bathing for 4 weeks. All groups will have instructions to use a walking aid and a toilet seat if needed, to weight-bear as tolerated, and to avoid driving for 3 weeks.
15879869|NCT03806101|Drug|PF-04965842|200 mg dose of PF-04965842 once daily (QD) for 3 days
15879870|NCT03806101|Drug|Rosuvastatin|Single 10 mg dose of rosuvastatin
15881548|NCT03792984|Dietary Supplement|Calcium Carbonate|Calcium carbonate (1000 mg/daily). PO for 8 weeks.
15879871|NCT03806075|Behavioral|Second generation sequencing|Firstly, all Peutz-Jeghers patients accept second generation gene sequencing with their blood specimen
15879872|NCT03806075|Behavioral|16s rRNA gene sequencing|Secondly, All patients and Health persons accepted 16s rRNA gene sequencing with their feces specimen
15879873|NCT03806062|Drug|domperidone|10 mg domperidone 3 times a day after meals
15879874|NCT03806062|Device|He-Ne laser (Bravo TrezaSerie) device|The laser scan beam was adjusted to the size of the treated breast for 10 minutes with wave length 632.8 nm and power output 25 mw after the end of treatment session
15879875|NCT03806062|Device|faradic current|faradic stimulation (Body shaping System, model B-333, made in China) , at the following acupuncture points on both sides: Spleen 6 (Sanyinjiao), Liver 3 (Taichong) and Small Intestine 1 (Shaoze)
15879876|NCT03806049|Drug|Niraparib|given orally once daily
15879877|NCT03806049|Drug|Bevacizumab|given as iv infusion every three weeks
15879878|NCT03806049|Drug|TSR042|Given as IV infusion every three weeks
15879879|NCT03806049|Drug|Carboplatin|given as iv infusion every three weeks
15879880|NCT03806049|Drug|Paclitaxel|given as iv infusion every three weeks
15879881|NCT03806036|Drug|Vitamin D|300.000 I.U single dose of VIT D IM injection
15879882|NCT03806036|Drug|Clomiphene Citrate|100mg daily for 5 days starting from third day of menstruation
15879883|NCT03806023|Device|hand movements (signals from thumb muscle) triggered PNS and TMS|"PNS, TMS or PNS+TMS will be delivered while the participant performs specific finger tasks at different degrees of effort.
~This is an experiment designed to detect momentary changes in muscle function."
15879884|NCT03806010|Procedure|Quantitative sensory testing|Quantitative sensory testing
15879885|NCT03805997|Device|Dietary advice|participants will benefit of dietary device 30-minute dietary advice carried out by a doctor at the University Hospital of Rennes, in order to provide nutritional advice adapted to pregnant women.
15879886|NCT03805997|Other|Consumption of Bleu-Blanc-Coeur products|consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day
15879887|NCT03805997|Other|No consumption of Bleu-Blanc-Coeur products|no consumption of Bleu-Blanc-Cœur products from the 29th week of amenorrhea to the 45th postpartum day. This group will receive Système U vouchers.
15879888|NCT03805997|Biological|Blood sample|the fatty acid profile of the women red blood cells of the woman wil be test at the inclusion and at 21 days post-partum
15879889|NCT03805997|Other|Contact|Participants of the group A will be contacted by phone,sms, mail by a technician every 15 days from 7th month of pregnancy to the 8th month of pregnancy and then every week from the 9th month of pregnancy to the 45th postpartum day (except the week of childbirth), in order to collect their consumption data of the delivered food products.
15879890|NCT03805997|Other|food questionnaire|Participants will have to complete a food questionnaire at the inclusion and at 21 days post-partum
15879891|NCT03805997|Other|newborn faeces sample|Newborn faeces sample will be collected at 21 Days post partum
15879892|NCT03805997|Other|breast milk sample|Breast milk sample will be collected at 21 days and 45 days post partum
15879893|NCT03805984|Drug|INO-4500|INO-4500 will be administered ID on Day 0 and Week 4.
15879894|NCT03805984|Drug|Placebo|Placebo will be administered ID on Day 0 and Week 4.
15879895|NCT03805984|Device|CELLECTRA® 2000|EP using the CELLECTRA® 2000 device will be administered following ID drug administration.
15879896|NCT03805971|Device|Study of the pleural cavity with a confocal laser endomicroscope.|Probe based confocal laser endomicroscope can be introduced through the working chanel of the thoracoscope. this allows the study of the pleural cavity with this new tool.
15879897|NCT03805958|Procedure|realtime ultrasonography|Applying realtime ultrasound during the combined anesthesia
15879898|NCT03805958|Procedure|prescan ultrasonography|Applying realtime ultrasound before the combined anesthesia
15879899|NCT03805945|Drug|dexmedetomidine group|After the fetus was delivered, low-dose dexmedetomidine intraoperative infusion, postoperative low-dose dexmedetomidine patient-controlled intravenous analgesia pump(the background infusion is 2 ml/h, the bolus dose is 0.5 ml, the lock time is 15 min).
15879900|NCT03805945|Drug|control group|After the fetus was delivered, saline intraoperative infusion, postoperative patient-controlled intravenous analgesia pump(the background infusion is 2 ml/h, the bolus dose is 0.5 ml, the lock time is 15 min) without dexmedetomidine.
15879903|NCT03805906|Procedure|L5 Dorsal ramus block|Ultrasound-guided L5 dorsal ramus block
15879904|NCT03805893|Procedure|Moderate heat pain|To apply a sensory challenge that can be applied over longer periods required for PET imaging and that is also compatible with high magnetic fields during MRI scanning, we will use a well-established thermal challenge of the lower extremity. To apply mildly painful heat to the patient, the right leg (from the foot up to the knee) will be wrapped in a blanket that incorporates a network of small-diameter plastic tubing through which hot water (45 - 55 oC) is circulated from a temperature-controlled reservoir.
15879905|NCT03805880|Diagnostic Test|cerebral desaturation monitoring and cognitive examination|Before general anesthesia, continuous monitoring of cerebral oxygenation(rSO2) was started using an INVOS 5100 (Somaneic, Tro, MI) .Patient cognitive function was assessed using Mini-Mental State Examination (MMSE) on the day before surgery (baseline) and then after 1 day after surgery.
15879906|NCT03805854|Device|10 Hz tACS of the bilateral somatosensory cortex|10 Hz tACS at 1 mA will be applied over the bilateral somatosensory cortex for 10 minutes using a Neuroconn stimulator (DC-Stimulator MR; Neuroconn, Ilmenau, Germany) and 2 5*5 cm rubber electrodes placed at electrode positions CP3 and CP4 according to the international 10-20 system.
15879907|NCT03805854|Device|10 Hz tACS of the prefrontal cortex|10 Hz tACS at 1 mA will be applied over the prefrontal cortex for 10 minutes using a Neuroconn stimulator (DC-Stimulator MR; Neuroconn, Ilmenau, Germany) and 2 5*5 cm rubber electrodes placed at electrode positions F3 and F4 according to the international 10-20 system.
15879974|NCT03805334|Other|Touchpoints|Touchpoints are worn on either the wrists or ankles. They deliver a low level vibration in an alternating fashion to the skin.
15889979|NCT03727464|Drug|Sevoflurane|Sevoflurane general anesthesia
15879908|NCT03805854|Device|80 Hz tACS of the bilateral somatosensory cortex|80 Hz tACS at 1 mA will be applied over the bilateral somatosensory cortex for 10 minutes using a Neuroconn stimulator (DC-Stimulator MR; Neuroconn, Ilmenau, Germany) and 2 5*5 cm rubber electrodes placed at electrode positions CP3 and CP4 according to the international 10-20 system.
15879909|NCT03805854|Device|80 Hz tACS of the prefrontal cortex|80 Hz tACS at 1 mA will be applied over the prefrontal cortex for 10 minutes using a Neuroconn stimulator (DC-Stimulator MR; Neuroconn, Ilmenau, Germany) and 2 5*5 cm rubber electrodes placed at electrode positions F3 and F4 according to the international 10-20 system.
15879910|NCT03805854|Device|Sham stimulation of the bilateral somatosensory cortex|10 Hz tACS at 1 mA will be applied over the bilateral somatosensory cortex for 10 seconds at the beginning of the experimental session using a Neuroconn stimulator (DC-Stimulator MR; Neuroconn, Ilmenau, Germany) and 2 5*5 cm rubber electrodes placed at electrode positions CP3 and CP4 according to the international 10-20 system.
15879911|NCT03805854|Device|Sham stimulation of the prefrontal cortex|10 Hz tACS at 1 mA will be applied over the prefrontal cortex for 10 seconds at the beginning of the experimental session using a Neuroconn stimulator (DC-Stimulator MR; Neuroconn, Ilmenau, Germany) and 2 5*5 cm rubber placed at electrode positions F3 and F4 according to the international 10-20 system.
15879912|NCT03805841|Drug|tarloxotinib bromide|weekly intravenous infusion
15879913|NCT03805828|Other|Educational program on parenting stress and coping mechanism|The educational program will deliver as a one-day event in four sessions: (1)background of autism spectrum disorder(ASD) and coping mechanism,(2) targeting communication and social difficulties among ASD children using coping mechanism,(3) targeting behavior problems among ASD children using coping mechanism, and (4) stress management as coping mechanism. The contents of the educational program deliver through the use of PowerPoint slides, Whiteboard and marker, practical exercise, video clips followed by group discussion and provision a hard copy booklet containing all items which were supposed to discuss. As well as each session will approximately be taken one hour. Each group will consist of 10 participants.
15879914|NCT03805815|Device|tunable crack sensor|blood pressure monitoring via crack sensor
15879915|NCT03805802|Other|active product|Once daily consumption over the period of the study
15879916|NCT03805802|Other|reference product|Once daily consumption over the period of the study
15879919|NCT03805776|Other|Fasting (diet restruction for specific period)|12-14 hours fasting
15879920|NCT03805763|Procedure|Large extent of ILM Peeling|The extent of ILM peeling is 4DD
15879921|NCT03805763|Procedure|Small extent of ILM Peeling|The extent of ILM peeling is 2DD
15879924|NCT03805737|Other|Amulez and sunlight|Amulez and sun exposure for 2 hours
15879925|NCT03805737|Other|Amulez and red light treatment|Amulez and red light treatment for 10 minutes
15879926|NCT03805724|Other|Plaque Samples|After carefully drying of the selected site and isolation by cotton roll, plaque samples will be collected by sweeping movement of the probe at gingival crevices of the tooth aspect with pervious inclusion criteria for obtaining of the plaque sample. Samples will be immediately dipped in sterile Eppendorf tubes containing PVA.
15879927|NCT03805711|Device|HLT® Transcatheter System|Transcatheter aortic valve replacement using The HLT® Transcatheter System (HLT System) in patients with symptomatic heart disease due to severe aortic stenosis who are judged by the Heart Team to be at Intermediate or High Risk for aortic valve replacement surgery (Heart Team agrees that the risk of 30-day mortality is ≥ 3%).
15879928|NCT03805698|Device|Platelet-rich Plasma (PRP)|The CASCADE Autologous Platelet System is a product made commercially available by the Musculoskeletal Transplant Foundation (MTF) for PRP processing. Once processed, the PRP is injected into the debrided wrist.
15879929|NCT03805698|Other|Standard Arthroscopic Debridement|Standard arthroscopic debridement. No PRP injection.
15879930|NCT03805685|Procedure|Non-Cardiac Surgery|Non-cardiac surgery
15879931|NCT03805672|Drug|Low Dose Enoxaparin|
15879932|NCT03805672|Drug|High Dose Enoxaparin|
15879933|NCT03805659|Device|HD-tDCS|High-Dose transcranial Direct Current Stimulation
15879934|NCT03805659|Device|Sham|Sham sessions (no electric current)
15879935|NCT03805646|Other|Mobile Phone-based Triage Tool|The proposed intervention is a mobile phone-administered survey. Participants that have been admitted to participating hospitals for treatment of injury will be contacted by mobile phone approximately two weeks after discharge. A seven-question survey will be administered over the phone to each participant. Cross-validation with a separately administered in-person physical exam will be performed to assess the survey tool's prediction of who needs further care for treatment of their injury.
15879936|NCT03805633|Diagnostic Test|Venous blood sample|Venous blood samples will be obtained for hemoglobin A1c, C peptide, insulin level, and 2-hour fasting glucose tolerance test.
15879937|NCT03805633|Diagnostic Test|Ultrasound of pancreas|Ultrasound of pancreas will be obtained on all study participants.
15879938|NCT03805620|Other|Combined physical-cognitive training|combined physical-cognitive training
15879939|NCT03805620|Other|Physical training|Multi-component physical exercise
15879940|NCT03805620|Other|Cognitive training|cognitive training
15879941|NCT03805607|Drug|Ketorolac Tromethamine 30 MG/ML|Ketorolac 30 mg
15879942|NCT03805607|Drug|Placebos|Normal Saline
15879943|NCT03805594|Drug|Lutetium Lu 177-PSMA-617|Given IV
15879944|NCT03805594|Biological|Pembrolizumab|Given IV
15879945|NCT03805581|Drug|Defibrotide|Defibrotide 6.25 mg/kg IV q6h up to 7 days
15879946|NCT03805568|Drug|dexmedetomidine infusion group|dexmedetomidine as anaesthetic adjuvant
15879947|NCT03805568|Drug|remifentanil infusion group|remifentanil as anaesthetic adjuvant
15879948|NCT03805555|Procedure|Radiofrequency ablation|Pulmonary vein isolation by radiofrequency ablation
15879949|NCT03805555|Procedure|Cryoballoon ablation|Pulmonary vein isolation by cryoballoon ablation
15879950|NCT03805542|Combination Product|0.5% Iodophors|Before lithotripsy, 0.5% iodophor 40 ml(depending on the degree of hydronephrosis) was used to perfuse the calculous side pelvis under low pressure for 5 minutes.
15879951|NCT03805516|Behavioral|SCOPP-CW|The proposed intervention integrates the Social Cognitive Theory, use of everyday technology (WeChat), and an adaptation of an evidence-based program that is tailored to the behavior patterns, preferences, and cultures of premenopausal Chinese American women. The intervention includes three components: (1) daily tracking of physical activities, (2) 12 weekly educational modules on healthy lifestyle, physical activity, and breast cancer prevention, and (3) 6 bi-weekly tailored messages to include tips for lifestyle modification, stress management, and healthy weight maintenance based on the user's personal characteristics and behavior patterns.
15879952|NCT03805516|Behavioral|Control|This is the comparative/control group for the intervention. The control group receives daily tracking of physical activity and 12 weekly non-tailored educational information on general health topics.
15879953|NCT03805503|Drug|Chloroprocaine 1% Injectable Solution|"standard CSE procedure in outpatients for inguinal hernia. The first spinal dose of chloroprocaine 1% to start with is 50mg. This dose has been successfully used for spinal anesthesia in hernia repair outpatients to reach an adequate analgesia. 2,5 microgram of sufentanil will be added for prolongation of the analgesia. The testing interval is 2 mg.
~Efficacy of the analgesia will be evaluated:
~Successful : sensory block at or above T6 dermatome bilateral at the beginning of surgery without additional analgesia during surgery. Unsuccessful: sensory block under T6 dermatome bilateral and/or VAPS is more than 10 mm at the beginning of surgery what necessitates additional epidurals analgesia.
~Patients who indicate an ineffective result will receive a rescue treatment by the administration of 5 ml chloroprocaine 3% epidural every 5 minutes with maximum of 30ml. When CSE fails, general anesthesia will be performed."
15879954|NCT03805477|Drug|Nintedanib|Nintedanib 150 mg Kps bid (oral); in order to manage adverse events, the dose of Nintedanib may be reduced from 150 mg twice daily to 100 mg twice daily
15879955|NCT03805464|Other|Knee Joint Effusion|60mL saline injection into the supra-patellar region of the knee
15879956|NCT03805451|Behavioral|Life Steps for PrEP for Youth|Life-Steps is a modular adherence intervention based on principles of cognitive-behavioral therapy (CBT), that allows for recipients of the intervention to focus on the greatest challenges that they perceive in maintaining optimal adherence to pre-exposure prophylaxis.
15879957|NCT03805438|Drug|Chloroprocaine Hcl 3% Inj|"Initial Patient (A#X) 45mg (1.5mL) of Chloroprocaine 3% (Nesacaine - Fresenius Kabi), will be drawn up into a 3 ml syringe (a 1 ml 'TB syringe' will be used to aspirate the drug in aliquots to ensure accuracy). The following additive will be added: 10 mcg (0.2ml) of fentanyl (50 mcg/ml) 0.3 ml of sterile 0.9% sodium chloride Thus the total volume in the syringe will be 2 ml. Study drugs will be prepared by one anesthesiologist (un-blinded) and administered by another anesthesiologist (blinded).
~Subsequent Patient (A#X+1) The dose of Chloroprocaine 3% based on outcome from prior subject and calculations mentioned previously will be added to 10 mcg (0.2ml) of fentanyl (50 mcg/ml). Sterile 0.9% sodium chloride will be added until the total volume in the syringe is 2 ml."
15879958|NCT03805425|Radiation|PiXL|The system is set to deliver 30 mW/cm2 UVA irradiance in pulsed intervals of 1 second on and 1 second off to 5 to 9 mm diameter corneal annulus. Total energy delivered is 15J.
15879959|NCT03805412|Device|DEXCOM G6 RT-CGM|CGM is a way to measure glucose levels in real-time. A tiny electrode called a glucose sensor is inserted under the skin to measure glucose levels in tissue fluid. A small plastic piece of tube remains inserted in the skin. It is connected to a transmitter that sits on top of the skin. It is approved for use on the abdomen for 10 days. It either records the sugars downloaded in the clinic (blinded part of the study) or it sends the information via wireless radio frequency to a monitoring/ display device or to a cellular phone so participants can see data. DEXCOM G6 is FDA approved for use in patients with diabetes and will be used in accordance with instructions as approved for diabetes.
15879960|NCT03805399|Drug|Pyrotinib with Capecitabine|If patients were LAR subtype with HER2 gene activated mutation, she would receive pyrotinib(EGFR-TKI) 400mg qd and capecitabine 1000mg/m2 bid (d1-d14)
15879961|NCT03805399|Drug|AR inhibitor with CDK4/6 inhibitor|B1: if patients were LAR subtype without HER2 gene activated mutation, but had PI3KCA mutation, she would receive everolimus 10mg qd combined with AR inhibitor SHR3680 240mg qd continuously ; B2: if patients were LAR subtype without HER2 gene activated mutation or PI3KCA mutation, she would receive AR inhibitor SHR3680 240mg qd combined with CDK4/6 inhibitor SHR6390 150mg qd (three week on one week off)
15879962|NCT03805399|Drug|anti PD-1 with nab-paclitaxel|If patients were IM subtype, she will receive PD-1 antibody SHR1210 200mg q2w and nab-paclitaxel 100mg qw (three week on one week off).
15879963|NCT03805399|Drug|PARP inhibitor included therapy|If patients were BLIS subtype and had a BRCA gene pathogenic mutation, she will receive PARP inhibitor SHR3162 150mg bid and famitinib 20mg qd continuously .
15879964|NCT03805399|Drug|BLIS with anti-VEGFR included therapy|"If patients were BLIS subtype and did not have a BRCA gene pathogenic mutation , she will receive:
~E2: apatinib 250mg qd continuously combined with VP-16 50mg qd (three week on one week off); E3: famitinib 20mg qd continuously combined with VP-16 50mg qd (three week on one week off)"
15879965|NCT03805399|Drug|MES with anti-VEGFR included therapy|If patients were MES subtype and without PI3K/AKT pathway activation,she will receive famitinib 20mg qd continuously combined with VP-16 50mg qd (three week on one week off).
15879966|NCT03805399|Drug|mTOR inhibitor with nab-paclitaxel|If patients were MES subtype and had PI3K/AKT pathway activation, she will receive mTOR inhibitor 10mg qd continuously combined with nab-paclitaxel 100mg qw (three week on one week off).
15879967|NCT03805386|Drug|Physician directed opioid prescribing|Oxycodone 5mg 1-2 tablets every 4 hours as needed for pain. 30 tablets will be provided.
15879968|NCT03805386|Drug|Patient directed opioid prescribing|Oxycodone 5mg amount ranging from 0 tablets to as much as 30 tablets as described in the standard of care.
15879969|NCT03805373|Other|Diet Assessment Survey|Participants will complete 2 different diet assessment tools separated by at least 1 week.
15879970|NCT03805360|Drug|Ropivacaine|Ropivacaine is a local anesthetic that is expected to provide numbness to the chest wall when injected into the erector spinae plane.
15879971|NCT03805360|Drug|Normal Saline Flush, 0.9% Injectable Solution|Normal Saline Flush, 0.9% Injectable Solution is not expected to provide numbness to the chest wall when injected into the erector spinae plane.
15879972|NCT03805347|Drug|Helminthostachys zeylanica(L.)Hook|Extract of Helminthostachys zeylanica(L.)Hook, 1gm/time, 3 times daily
15879973|NCT03805347|Drug|Starch|Starch in capsule, 1gm/time, 3 times daily
15880473|NCT03801421|Procedure|Mass continous suture with PDS|The surgical incision will be treated by mass continous suture with PDS.
15879975|NCT03805308|Procedure|Intra-arterial Therapy|Mechanical Thrombectomy is a treatment for stroke that removes clots that block large blood vessels.
15879976|NCT03805295|Other|BOKS Program|12-week physical activity program, occurring 3x/week, lasting 30-60 minutes per session.
15879977|NCT03805282|Drug|Lidocaine|Continuous infusion, variable dose of lidocaine.
15879978|NCT03805269|Drug|TAP block|TAP block: local anesthetics infiltration at trans abdominis plane
15879979|NCT03805269|Drug|wound infiltration|wound infiltration: local anesthetics infiltration at surgical incision
15879980|NCT03805243|Device|test of sensors for somnonaute device|test of sensors
15879981|NCT03805243|Device|test of sensors for uronaute device|test of sensors
15879982|NCT03805243|Device|test of sensors for toconaute device|test of sensors
15879983|NCT03805243|Device|test of sensors for neuronaute device|test of sensors
15879984|NCT03805243|Device|test of sensors for cardioskin device|test of sensors
15879985|NCT03805217|Device|EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software|EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software
15879987|NCT03805178|Drug|Belatacept|"Initial phase: 10 mg/kg on days 0 and 4, and again at weeks 2 and 4. Maintenance phase: 10 mg/kg every month beginning 4 weeks after completion of the initial phase.
~No dosage adjustments required for renal or hepatic impairment. No known drug interactions for usual post-transplant medication regimen."
15879988|NCT03805178|Drug|Carfilzomib|20mg/m2 Plasmapheresis
15879989|NCT03805152|Drug|Neuronox(R)|Injection botulinum toxin intramuscular for affected neck muscle
15879990|NCT03805152|Drug|Dysport (R)|Intramuscular injection
15879991|NCT03805139|Dietary Supplement|Ajwa Date (phoenix dactylifera)|Effect of Ajwa on Dyslipidemia
15879992|NCT03805126|Behavioral|Medical Legal Partnership|With the medical legal partnership, lawyers are embedded in clinics, and lawyers consult with patients who are identified as having health-harming legal needs (HHLNs). This arm will also receive usual care, which includes consultation with a social worker and a community health worker.
15879993|NCT03805126|Behavioral|Usual Care|Usual care includes consultation with a social worker and a community health worker.
15879994|NCT03805113|Device|Magnetotherapy device|Use of magnetotherapy device 15 consecutive working days in elegible patients with erosive hand osteoarthritis.
15879995|NCT03805113|Device|Placebo|Use of unplugged magnetotherapy device 15 consecutive working days in elegible patients with erosive hand osteoarthritis.
15879996|NCT03805100|Biological|Ranibizumab|Intravitreal injection
15879997|NCT03805087|Procedure|Transarterial coil embolization|Transarterial coil embolization of the superior rectal arteries via a transradial left arterial access.
15879998|NCT03805061|Other|'aerobic exercise'|The aerobic exercise group by using treadmill their walking speeds were adjusted according to the maximum speed at which the person could walk was performed a period of; 8 weeks, 3 days a week, 30-45 minutes each patient.
15879999|NCT03805061|Device|'isokinetic exercise'|Patients in the isokinetic exercise group pedaled a bicycle ergometer for warming with low exercise and exercise was applied for 5-10 minutes to cool down at the end of the study. were included in a rehabilitation program that they would apply for 3 days per week for 8 weeks.The measuring of isokinetic muscle strength, CSMI Humac Norm isokinetic dynamometer's commonly used angular velocities of 60 ° and 180 ° / sec was used.
15880000|NCT03805048|Procedure|Percutaneous coronary intervention|PCI of the bypass graft will be performed by current standards and at the discretion of the operator. Only commercially available second generation DES - XIENCE Sierra will be used. In case of a CTO lesion, the aforementioned hybrid approach will be applied.This approach uses several angiographic characteristics to guide strategical planning of the procedure, using 4 complementary techniques to cross a CTO: antegrade wire escalation, antegrade dissection reentry, retrograde wire escalation, retrograde dissection reentry. In case of PCI failure, a second attempt can be performed within 1 month. Patients will be hospitalized for a min. of 6-8 hours after PCI and receive DAPT prior to the procedure or triple therapy in case of indication for oral anticoagulation, their duration according to the current guidelines of the ESC for stable coronary disease or ACS.
15880001|NCT03805035|Device|electroacupuncture|Group 2 (n=10) EA at ST36 and GB34;intensity (2 mA), pulse width (1 ms), frequency (2 Hz)
15880002|NCT03805035|Drug|antihistamine(low dose) chlorpheniramine (Dexchlorpheniramine maleate)|Group 3 (n=10) EA at ST36 and GB34 plus chlorpheniramine (Dexchlorpheniramine maleate 2mg/tab, 1 tab);intensity (2 mA), pulse width (1 ms), frequency (2 Hz)
15880003|NCT03805035|Drug|antihistamine(high dose) chlorpheniramine (Dexchlorpheniramine maleate)|Group 4 (n=10) EA at ST36 and GB34 plus chlorpheniramine (Dexchlorpheniramine maleate2mg/tab, 2 tabs);intensity (2 mA), pulse width (1 ms), frequency (2 Hz)
15880004|NCT03805035|Device|acupuncture|Minimal needling at ST36 and GB34
15880005|NCT03805022|Drug|Doxorubicin|A treatment cycle consists of 3 weeks. Doxorubicin will be administered from day 1 to day 3 (60-75mg/m² day or 20-25 mg/m² per day), repeated every 3 weeks, up to 3 cycles.
15880006|NCT03805022|Drug|Ifosfamide|A treatment cycle consists of 3 weeks. Treatment may continue up to 3 cycles. Ifosfamide will be administered from day 1 to day 3 (7,5-9 g/m² over 3 days with mesna and G-CSF), repeated every 3 weeks, up to 3 cycles.
15880007|NCT03805022|Drug|Doxorubicin|A treatment cycle consists of 3 weeks. Doxorubicin will be administered from day 1 to day 3 (60-75mg/m² day or 20-25 mg/m² per day), repeated every 3 weeks, up to 6 cycles.
15880008|NCT03805022|Drug|Ifosfamide|A treatment cycle consists of 3 weeks. Ifosfamide will be administered from day 1 to day 3 (7,5-9 g/m² over 3 days with mesna and G-CSF), repeated every 3 weeks, up to 6 cycles.
15880009|NCT03805022|Drug|At the discretion of the investigator|Drug at the discretion of the investigator.
15880010|NCT03805009|Device|Robot-Assisted Gait Training (RAGT)|The Robotic Group (RG) performs a Robot-Assisted Gait Training (RAGT) using an end-effector robotic device (G-EO system-Reha Technology-Olten, Switzerland).
15880011|NCT03804996|Drug|TG-1801|Intravenous infusion over 1 hour every 4 weeks
15880012|NCT03804996|Biological|Ublituximab|"recombinant chimeric anti-CD20 monoclonal antibody, available in 25 mg/mL administered as an IV infusion once every 4 weeks"
15880075|NCT03804515|Drug|14C-labeled poziotinib|a single capsule containing 12 mg of 14C-labeled poziotinib (approximately 90 to 110 μCi) will be administered orally
15880013|NCT03804983|Device|Hybrid Closed Loop (HCL)|Participants will use Control-IQ with Hybrid Closed Loop (HCL) with their own insulin parameters during the entire two-week study, including the 72-hour ski admission and the at-home study collection times. Parameters will be reduced 20% during the ski admission to adjust for the increased activity.
15880014|NCT03804983|Device|Control-IQ with MyTDI|Participants will use their own insulin parameters during the first 5 days of the study. After randomization at the ski admission, the participants insulin parameters will be modified using the MyTDI calculations. Additionally, parameters will be reduced 20% during the ski admission to adjust for the increased activity.
15880015|NCT03804970|Behavioral|cash rewards for the fellow up|This is a multiple stimulus intervention study, and there are two intervention groups. One is the normal intervention group, and the other is the adjusted intervention group. The intensity of intervention in the latter group is based on the severity of diabetic disease.
15880016|NCT03804970|Behavioral|Showing retinal photos to participants|This is a multiple stimulus intervention study, and there are two intervention groups. One is the normal intervention group, and the other is the adjusted intervention group. The intensity of intervention in the latter group is based on the severity of diabetic disease.
15880017|NCT03804970|Behavioral|SMS reminders for participants and their family|This is a multiple stimulus intervention study, and there are two intervention groups. One is the normal intervention group, and the other is the adjusted intervention group. The intensity of intervention in the latter group is based on the severity of diabetic disease.
15880018|NCT03804970|Behavioral|Watching brief video and basic explanation for disease|This basic explanation will be offered by professional doctors or nurses.
15880019|NCT03804970|Behavioral|Having the Diabetic Club|This is a multiple stimulus intervention study, and there are two intervention groups. One is the normal intervention group, and the other is the adjusted intervention group. The intensity of intervention in the latter group is based on the severity of diabetic disease.
15880020|NCT03804957|Other|Autologous blood patch injection (ABPI)|Autologous blood patch injection (ABPI) through a coaxial needle at the site of biopsy
15880021|NCT03804957|Other|CT-guided core needle biopsy (CNB)|Standard 18g lung core biopsy
15880022|NCT03804944|Radiation|Focal Radiation therapy|Focal hypo-fractionated radiation therapy 8 Gy x 3 fractions, starting day 8, every other day (M/W/F or W/F/M or F/M/W).
15880023|NCT03804944|Drug|Pembrolizumab (200mg IV for 30 minutes|Pembrolizumab, on day 12 (last day of radiotherapy), infused over 200mg IV over 30 minutes and then repeated every 3 weeks until disease progression or unacceptable toxicity.
15880024|NCT03804944|Biological|CDX-301|Ftl-3 ligand, self-administered by subcutaneous injections at week 1, daily, for 5 consecutive days.
15880025|NCT03804931|Procedure|Fecal microbiota transplantation|200 mL of prepared fecal microbiota suspension from healthy donors' fresh feces was injected into the intestine
15880026|NCT03804931|Procedure|Infusion of Saline|Infusion of Saline
15880027|NCT03804931|Drug|5-Aminosalicylic acid(5-ASA) and/or Prednisone|Mesalazine and/or Prednisone
15880028|NCT03804918|Other|VitalTips mobile application|VitalTips is a mobile learning application with learning on breaking bad news. Participants were expected to spend at least three hours using the mobile learning resource, ensuring that the time did not impact on their clinical and academic commitments.
15880029|NCT03804905|Other|Drug cards|Patients will be given a drug card and an information sheet that describes how the cards can be used. The patients can then use the cards when filling prescriptions at any pharmacy to get free access to diabetes, blood pressure and cholesterol medications, and for glucose test strips.
15880030|NCT03804892|Diagnostic Test|Body Composition|Participants undergo a 5 minute body scan to determine their body composition.
15880031|NCT03804892|Diagnostic Test|Maximal aerobic fitness test|Participants will complete a walking fitness text until exhaustion to determine maximal aerobic capacity.
15880032|NCT03804892|Diagnostic Test|Oral glucose tolerance test|Participants will undergo an OGTT to determine insulin sensitivity.
15880033|NCT03804892|Other|Muscle biopsy|Participants will give a small muscle sample pre-, immediately post and 3 hours post- the exercise trial to be assessed for lipid metabolites.
15880034|NCT03804892|Other|Blood samples|Participants will give 16 blood samples, to be assessed for fatty acids in the blood.
15880035|NCT03804879|Drug|LMB763|LMB763 capsule
15880036|NCT03804879|Other|Placebo|Placebo capsule
15880037|NCT03804866|Drug|NGR-hTNF|NGR-hTNF: 0.8 mcg/m² as 60 minutes intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs
15880038|NCT03804866|Drug|Pegylated liposomal doxorubicin|50 mg/m² iv every 4 weeks until confirmed evidence of disease progression
15880039|NCT03804866|Drug|Doxorubicin|60 mg/m² iv every 3 weeks for a maximum of 8 cycles
15880040|NCT03804853|Other|Rehabilitiation|This study will be a non-blinded randomized controlled outcomes study evaluating outcomes at baseline, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year post-operatively from a primary reverse total shoulder arthroplasty with two different post-operative physical rehabilitation protocols. There will be 2 groups, one undergoing the immediate active shoulder physical therapy protocol consisting of four quadrant stretches and full active motion of the shoulder from post op day 1 in the hospital. The second group will follow the traditional TRIA physical therapy protocol consisting of PT (standard of care) followed by a gradual return to active range of motion of the shoulder beginning by week 6, calling for 18 physical therapy visits. The physical therapy will occur where the patient is most comfortable receiving it.
15880041|NCT03804840|Drug|Dronabinol|THC (Marinol® [dronabinol]; Solvay Pharmaceuticals) will be orally administered in doses of 7.5 mg and 15 mg, in opaque capsules with dextrose filler. Placebo capsules contain only dextrose. These doses of THC are known to produce performance impairments as well as subjective intoxication (Broyd et al, 2016; Hartman and Huestis, 2013).
15880042|NCT03804840|Drug|Placebo|Placebo
15880043|NCT03804814|Behavioral|Motivational Interviewing Training|"Motivational Interviewing is a directive, client-centered counselling style intended to elicit behavior change by helping patients reach health goals through their own desires and actions.
~A certified and experienced Motivational Interviewing trainer will develop and deliver the curriculum to healthcare providers."
15880044|NCT03804801|Dietary Supplement|Hibiscus Sabdariffa|The extract of the plant Hibiscus Sabdariffa, also known as sour or red tea
15880171|NCT03803761|Drug|Copanlisib|Given IV
15880045|NCT03804788|Behavioral|Cognitive Behavioral Therapy for Insomnia|Cognitive Behavioral Therapy for Insomnia (CBT-I). Participants assigned to the CBT-I condition will attend 1-hour individual sessions of CBT-I once a week for five weeks. A sixth week of treatment will be included - and scheduled for the same date as the post-treatment assessment - if the participant and research team agree that it would be beneficial (e.g., if a participant has difficulty grasping cognitive therapy concepts). Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, & Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.
15880046|NCT03804788|Behavioral|Sleep Hygeine|All participants will receive a one-page handout on sleep hygiene that includes personalized normative feedback on their alcohol use. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
15880047|NCT03804775|Diagnostic Test|Serum lipid profile|Blood samples drawn from the patients and controls will be analyzed for serum cholesterol, serum triglycerides, serum LDLs and serum HDL levels. All the results will be recorded on a performa
15880048|NCT03804762|Procedure|the third space robotic and endoscopic cooperative surgery|This technique combines the endoscopic techniques and the merits of Da Vinci surgical robot, such as flexible and precise instruments, tremors filtering system and a 3-D surgical view, and take full advantage of the methodology of the third space to dissect gastric submucosal tumors.
15880049|NCT03804749|Drug|suramin sodium|The trial will start from the low dose (10mg/kg) group, followed by the middle dose (15mg/kg) and high dose (20mg/kg) groups, only after the safety in the previous dose group has been demonstrated.。
15880050|NCT03804749|Other|placebo|Placebo is 0.9% sodium chloride injection.
15880051|NCT03804736|Biological|FMT-c|Patients in the FMT-c receive FMT-c (15 capsules every 12 h for 2 days)
15880052|NCT03804736|Biological|FMT-c Lactobacillus|Patients in the FMT-c Lactobacillus receive FMT-c Lactobacillus (15 capsules every 12 h for 2 days)
15880053|NCT03804723|Drug|oral Prednisone 5mg|patients randomized to this arm will stop prednisone 5 mg
15880054|NCT03804710|Drug|Developmental moisturizing cream 1|Participants will topically apply developmental moisturizing cream 1
15880055|NCT03804710|Drug|Developmental moisturizing cream 2|Participants will topically apply developmental moisturizing cream 2
15880056|NCT03804710|Other|Standard cleanser soap|Participants will cleanse the entire face and both lower legs (between the knees and the ankles)with simple pure soap
15880057|NCT03804697|Drug|selective anticoagulation|Selective anticoagulation group used anticoagulant once thromboelastography indicated hypercoagulable state. Conventional anticoagulation group used anticoagulant until one month after surgery routinely. The main difference was that the experimental group did not use anticoagulation if the thromboelastography indicated that the blood coagulation status was normal while the control group use anticoagulation routinely.
15880058|NCT03804684|Diagnostic Test|Standard Automatic Perimetry Humphrey Field Analyzer|Standard Automatic Perimetry (SAP) Humphrey Field Analyzer (HFA) 24-2, Swedish Interactive Threshold Algorithm (SITA) Standard Strategy measures peripheral and central vision in an ophthalmic setting.
15880059|NCT03804684|Diagnostic Test|visuALL Field Analyzer|visuALL Field Analyzer a new portable hardware and software virtual reality system measures peripheral and central vision to improve early detection of glaucoma damage in a non ophthalmic setting.
15880060|NCT03804671|Drug|BI 730357|Oral dose
15880061|NCT03804671|Drug|BI 730357 mixed with [C-14] BI 730357 BS|Intravenous dose
15880062|NCT03804658|Device|Continue glucose monitor system|The cardiovascular risks and data from continue glucose monitor system
15880063|NCT03804645|Drug|Treatment A|Each subject will receive single dose of AZD9977 capsule under fasting condition in Part A. If the formulation chosen for Part B, each subject will receive one dose under fed condition and another dose under fasted condition.
15880064|NCT03804645|Drug|Treatment B|Each subject will receive single dose of AZD9977 HDL capsule under fasting condition in Part A. If the formulation chosen for Part B, each subject will receive one dose under fed condition and another dose under fasted condition.
15880065|NCT03804645|Drug|Treatment C|Each subject will receive single dose of AZD9977 ODL capsule under fasting condition in Part A. If the formulation chosen for Part B, each subject will receive one dose under fed condition and other dose under fasted condition.
15880066|NCT03804645|Drug|Treatment D|Each subject will receive single dose of AZD9977 tablet under fasting condition in Part A. If the formulation chosen for Part B, each subject will receive one dose under fed condition and another dose under fasted condition.
15880067|NCT03804619|Device|Accelerated intermittent theta-burst stimulation (aiTBS)|aiTBS is an effective form of non-invasive brain stimulation which has been FDA-approved for the treatment of Major Depressive Disorder (MDD)
15880068|NCT03804606|Other|Referral to MTM Pharmacist|Patients will be referred for an encounter with a medication therapy management pharmacist.
15880069|NCT03804580|Drug|osimertinib|Non-randomized trial, all patients receive therapy
15880070|NCT03804567|Other|Oldpain2go®|This is a concept of dealing with a client in a way that uses their conscious mind to alter their unconscious automated programs such as chronic pain that are troubling them.
15880071|NCT03804567|Other|Routine low back pain management|Standard low back persistent physiotherapy management as recommended by national guidelines.
15880072|NCT03804554|Other|Non-Interventional|Non-Interventional
15880073|NCT03804541|Drug|Ensartinib|A novel, potent ALK inhibitor.The ALK inhibitor ensartinib has been validated in potency and selectivity assays indicating that it is more selective and up to 10 times more potent than competitive ALK inhibitors. Ensartinib has been active in animal models of non-small cell lung cancer (NSCLC) and neuroblastoma, a childhood cancer. Importantly, ensartinib has shown activity in models with ALK mutations that confer resistance to other small molecule ALK inhibitors.
15880074|NCT03804528|Behavioral|Aerobic Exercise|Participants will be fitted with a heart rate monitor and will be instructed to walk (or trot) to maintain 55-64% of maximal heart rate (determined by exercise test) for the first 4-weeks of exercise or to maintain 65-90% of maximal heart rate (determined by exercise test) for the second 4-weeks of exercise during each session.
15880076|NCT03804502|Device|TearCare|The TearCare System warms the eyelids to melt the meibum by applying heat to the external surface of the eyelids for 15 minutes. Following completion of the thermal portion of the procedure, the clinician performs manual expression of each of the eyelids.
15880077|NCT03804489|Other|Decision aids|Decision aids in helping the infant family to decide whether the infant will or will not receive the oral rotavirus vaccine.
15880078|NCT03804476|Drug|AER-271|AER-271, the test article for this study.
15880079|NCT03804476|Drug|Placebo|Placebo control for this study.
15880080|NCT03804463|Procedure|endometrial cancer radical surgery|Take hysterectomy and bilateral adnexectomy.
15880081|NCT03804463|Procedure|fertility-sparing surgery|Take endometrectomy , preserve uterus and bilateral ovaries.
15880082|NCT03804463|Procedure|ovarian preservation surgery|Take hysterectomy,preserve bilateral ovaries.
15880083|NCT03804450|Procedure|Regenerative endodontic procedures (REPs)|Instrumentation using rotary Pro-Taper Next, disinfection using sodium hypochlorite and calcium hydroxide as intracanal medication followed by induction of blood and application of Biodentine as a cervical plug.
15880084|NCT03804424|Drug|64Cu-LLP2A|-64Cu-LLP2A, will be manufactured following batch production record at the cyclotron GMP facility (Washington University School of Medicine GMP radiochemistry/cyclotron facility)
15880085|NCT03804424|Device|PET/MR|-All PET imaging will be performed as PET/MR or PET/CT
15880086|NCT03804424|Procedure|Blood samples for serum stability|-3 venous samples obtained from an IV site separate from the site of 64Cu-LLP2A injection (2 mL each) will be obtained at the following time points: Cohort 1: prior to injection, at completion of dynamic scanning in those who undergo dynamic imaging and at completion of one of the body imaging time points. In those who do not undergo dynamic imaging, prior to injection, and after completing body imaging at 2 of the 3 time points. Cohort 2: subjects will have samples drawn prior to injection, at completion of dynamic scanning, and at completion of body imaging.
15880087|NCT03804424|Procedure|Blood samples for metabolite analysis|-Typically, 2 blood samples obtained from an IV site separate from the site of 64Cu-LLP2A injection (preferably 1 within the first 5 min and 1 at the completion of the first hour of imaging) will be obtained.
15880088|NCT03804424|Procedure|Urine sample|-Cohort 1 only
15880089|NCT03804424|Procedure|Tumor biopsy|-Cohort 2 only and only if there hasn't been a recent biopsy of disease
15880090|NCT03804424|Procedure|Electrocardiogram|-A standard 12-lead ECG will be obtained on all subjects at baseline (within 30 mins prior to injection of 64Cu-LLP2A), and at least 60 minutes post injection or prior to study discharge
15880091|NCT03804424|Device|PET/CT|-All PET imaging will be performed as PET/MR or PET/CT
15880092|NCT03804411|Drug|Automatic system guided treatment|Addition of: 1A -vildagliptin 100 mg/day 2A - sitagliptin 100 mg/day, 3A- dapagliflozin 10 mg/day 4A- empagliflozin 10 mg/day 5A- liraglutide 1,2-1,8 mg/day 6A- exenatide 20 μg/day 7A - glimepiride 8A - gliclazide
15880093|NCT03804411|Drug|Standard treatment|"Addition of:
~B -vildagliptin 100 mg/day
~B - sitagliptin 100 mg/day,
~B- dapagliflozin 10 mg/day
~B- empagliflozin 10 mg/day
~B- liraglutide 1,2-1,8 mg/day
~B- exenatide 20 μg/day
~B - glimepiride
~B - gliclazide"
15880094|NCT03804398|Device|compliance guided an optimal Positive End-Expiratory Pressure|The study groups received an alveolar recruitment maneuver(increase inspiratory pressure to 30cmH2O for 10s) at the 10min after one-lung ventilation. After the alveolar recruitment maneuver,the study group titrate PEEP from 4cmH2O,increased in 2cmH2O steps and hold at each step for 1min,and the static pulmonary compliance(Cst) would be record.Optimal PEEP was determined until the maximal static pulmonary compliance was obtained.
15880095|NCT03804398|Device|PEEP level of 5 cmH2O|In the control group at PEEP level of 5 cmH2O was established and maintained during the study period
15880096|NCT03804385|Procedure|intercostal tube|surgical operation
15880097|NCT03804372|Drug|Rituximab|Patients will receive Rituximab+Chemotherapy+TAF for 6 months, followed by TAF as monotherapy for further 12 months. All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy and withdrawn 12 months after the completion of chemotherapy.
15880098|NCT03804372|Drug|Chemotherapy|Patients will receive Rituximab+Chemotherapy+TAF for 6 months, followed by TAF as monotherapy for further 12 months. All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy and withdrawn 12 months after the completion of chemotherapy.
15880099|NCT03804372|Drug|Tenofovir alafenamide|Patients will receive Rituximab+Chemotherapy+TAF for 6 months, followed by TAF as monotherapy for further 12 months. All subjects will receive TAF 1-3 weeks before Rituximab+Chemotherapy and withdrawn 12 months after the completion of chemotherapy.
15880100|NCT03804359|Drug|Rituximab|"In the personalized arm, the patient will be treated in function of the CysR activity result during the inclusion visit."
15880101|NCT03804346|Diagnostic Test|Acceleromyography|At the End of Surgery, shortly before Extubation, the TOF-Ratio is measured by an independent investigator using Acceleromyography.
15880102|NCT03804333|Radiation|standard treatment|3000 cGy in 10 daily fractions
15880103|NCT03804333|Radiation|short course treatment|2000 cGy in 4 fractions administered twice a day
15880104|NCT03804320|Other|Active Surveillance|
15880105|NCT03804307|Radiation|standard treatment|3000 cGy in 10 daily fractions
15880106|NCT03804307|Radiation|short course treatment|2000 cGy in 4 fractions administered twice a day
15880107|NCT03804281|Procedure|Test group|The surgery will be done with the use of 4x magnification loop, the knives are micro blades and micro-sutures 7//0 used with the microsurgical instruments kit
15880108|NCT03804281|Procedure|Control group|esthetic crown lengthening with conventional approach with an internal bevel incision, following CEJ anatomy, this will be followed by an intra-sulcular incision, removal of the strip of outlined marginal gingiva and elevation of a mucoperiosteal ﬂap to the level of the alveolar bone crest.
15880109|NCT03804268|Drug|AGN-190584|One drop bilaterally, once daily for 30 days
15880110|NCT03804268|Drug|Vehicle|One drop bilaterally, once daily for 30 days
15880111|NCT03804255|Other|Survey Administration|Complete surveys
15880112|NCT03804242|Behavioral|Black Youth M.A.T.T.E.R.: Molding Young Advocates While Transforming the School to Prison Pipeline Through Psychological Services Education and Resilience|This is a group psychoeducational and positive youth development intervention for students who have been expelled from school and are now enrolled in a specialized school at Youth Justice Coalition.
15880172|NCT03803761|Drug|Fulvestrant|Given IM
15880113|NCT03804229|Drug|Butylphthalide soft capsule|700 subjects are randomly divided into two groups by 1:1. About 350 patients in the active group take two pills(100mg each) of Butylphthalide soft capsule each time, three times a day, 0.5 hours before meal, taking with lukewarm water.
15880114|NCT03804229|Drug|Placebo soft capsule|700 subjects are randomly divided into two groups by 1:1. About 350 patients in the active group take two pills of placebo soft capsule each time, three times a day, 0.5 hours before meal, taking with lukewarm water.
15880115|NCT03804216|Other|Multimodal Imaging Analysis|The patients are seen in consultation ophthalmological before and the 1 hour after their session of dialysis. THE OCT angiography and other not invasive ophthalmological examinations will be realized during the follow-up
15880116|NCT03804203|Radiation|standard treatment|3000 cGy in 10 daily fractions
15880117|NCT03804203|Radiation|short course treatment|2000 cGy in 4 fractions administered twice a day
15880118|NCT03804190|Other|questionaire|dutch musculoskeletal questionaire
15880119|NCT03804177|Procedure|immediate implant placement with melatonin hyaluronic acid vit C|immediate implant placement with melatonin and hyaluronic acid and systemic administration vitamin C
15880120|NCT03804177|Procedure|immediate implant placement without melatonin hyaluronic acid vit C|immediate implant placement without melatonin and hyaluronic acid and systemic administration vitamin C
15880121|NCT03804164|Other|Educational Intervention|Attend Emerging from the Haze psychoeducational sessions
15880122|NCT03804164|Other|Quality-of-Life Assessment|Ancillary studies
15880123|NCT03804164|Other|Survey Administration|Ancillary studies
15880124|NCT03804151|Behavioral|FitSpirit intervention|The study evaluates the effects of the FitSpirit intervention on divers health markers of adolescents. Participants freely register to the intervention via their school. Physical activities and event are organized by the schools with the help of the FitSpirit organization.
15880125|NCT03804138|Other|Anti-influenza and DTp pertussis vaccinations|Anti-influenza and DTp pertussis vaccinations will be performed during the visit by the clinical research nurse. The vaccine has been prescribed as part of the care either by the patient's physician (pulmonologist or general practitioner).
15880126|NCT03804112|Diagnostic Test|Ultrasound exam with Doppler|Ultrasound exam of the neck to search a perivascular inflammation at the level of the carotid bifurcation.
15880127|NCT03804112|Biological|Blood samples|blood count , CRP and viral serologies (herpes virus, chlamydia, mycoplasma),
15880128|NCT03804099|Drug|Aflibercept Injection [Eylea]|After instillation of topical anesthetic, sterilization of the eyelid, and instillation of 1.25% povidone-iodine drops, 2.0 mg/0.05 mL of aflibercept (Eylea) is injected into the vitreous cavity through a standard pars plana approach (3.5 mm posterior to the limbus) under sterile conditions
15880129|NCT03804086|Procedure|Advanced PRF (A-PRF) + nano-crystalline hydroxyapatite bone substitute combined with open flap debridement|"will treated with OFD +A- PRF+ nano-crystalline hydroxyapatite bone substitute,10 mL of blood will be drawn from only patient assigned to the intervention group by vein puncture of the antecubital vein and is collected in sterile glass test tube, without any anticoagulant.
~The blood will be quickly collected, and the tube will immediately centrifuge at 1500 rpm for14 min at room temperature.
~After centrifugation, the A-PRF clot will be removed from the tube using sterile tweezers and placed on sterile woven gauze. Membrane will prepared by compressing clots between two pieces of woven gauze."
15880130|NCT03804086|Procedure|Open flap debridement|a periodontal access flap will be initiated by intrasulcular incisions on the buccal and lingual aspects. The incisions will be carried as far interproximally as possible to preserve the entire Interdental papillae and to achieve primary wound closure.
15880131|NCT03804073|Radiation|standard treatment|3000 cGy in 10 daily fractions
15880132|NCT03804073|Radiation|short course treatment|2000 cGy in 4 fractions administered twice a day
15880133|NCT03804060|Device|Thermogard XP3|Cooling with the ZOLL® Circulation catheter and the ZOLL® Intravascular Temperature Management system to initiate and maintain hypothermia for 6 hours as an adjunct to endovascular Recanalization.
15880134|NCT03804060|Procedure|Recanalization only|Standard of Care for recanalization
15880135|NCT03804047|Other|kinesio tape|kinesio tape is a therapeutic method used in the treatment of various musculoskeletal and neuromuscular deficits to provide support for muscles and increase or inhibit muscle recruitment, to correct joint malalignment, decrease swelling, and pain relieve
15880136|NCT03804034|Device|Block of resin|
15880137|NCT03804034|Device|Buccal tube, Bracket and 0.0017 × 0.025 in titanium molybdenum alloy wire|
15880138|NCT03804021|Genetic|ADVM-043|Long term follow- up of subjects that received ADVM-043
15880139|NCT03804008|Drug|Ultrasound-guided corticosteroid injection|A 21-gauge, 40 mm needle is connected to a 2.5 cm3 syringe filled with 1 ml Triamcinolonhexacetonid 20mg/ml + 1 ml Lidocain 10 mg7ml. The skin is cleansed with Chlorhexidine alcohol 0.5 %. The needle is inserted with a medial approach under ultrasound-guidance aligned to the long axis of the ultrasound transducer. The injection is placed anterior to the plantar fascia insertion on the calcaneal bone in the region of maximal fascia thickness. Participants are asked to start performing the exercise as soon as they feel ready but not before 24 hours after the injection. Furthermore, they are asked not to progress the method used to achieve 8RM when they start to do the exercise after the injection until Week 3 of the exercise programme. If standing on both feet was sufficient to achieve 8RM at baseline, the participant must not perform the exercise single-legged or to wear a backpack with weights after the injection regardless of any pain reduction afforded by the injection.
15880140|NCT03804008|Other|Heavy-slow resistance training|Participants will be asked to complete a heel raise standing with the forefoot on a step. The toes are maximally dorsi flexed by placing a towel underneath them. The participant is instructed to perform a heel raise to maximal plantar flexion in the ankle joint and afterwards to lower the heel to maximal dorsiflexion. Supporting oneself for balance by placing the hands on a wall or a rail is allowed. Participants are instructed in performing the exercise with a load as heavy as possible but no higher than 8RM and for as many sets as possible every other day.
15880141|NCT03804008|Other|Fundamental advice and a silicone heel cup|Participants receive brief information about pathology, risk factors and advice on how to decrease activities that lead to symptom flares and slowly increase their activity level based on their symptoms. They also receive a leaflet that includes the same information as the research assistants will deliver orally after inclusion and a silicone heel cup.
15889980|NCT03727451|Combination Product|iNO|inhaled nitric oxide
15880142|NCT03803995|Procedure|Mapping and Pacing the His Bundle|During the device implant procedure, 3D electro-anatomical mapping of the His Bundle region will be performed using EnSite™ Precision™ mapping system and Advisor™ HD Grid mapping catheter. This procedure might be part of the standard-of-care at the participating centers.
15880143|NCT03803995|Procedure|Placing a guidewire in Coronary sinus for measurement of Q-LV during His Bundle pacing or, if needed, for LV pacing|During the device implant procedure, a VisionWire coronary guidewire will also be placed into a branch of coronary sinus (CS), targeting a lateral branch. This guidewire could be used for collecting local left ventricle (LV) activation time (Q-LV) or pacing the LV. This guidewire could also be used to deliver a LV lead at physician's discretion. This procedure might be part of the standard-of-care at the participating centers.
15880144|NCT03803982|Procedure|Deep Neuromuscular Blockade|The proposed intervention in this study is delivery of an anesthetic with Deep Neuromuscular Blockage (NMB), which will be defined as a TOF of 0 and 2-3 twitches in the post-tetanic count.
15880145|NCT03803982|Drug|Sugammadex|Sugammadex will be used to reverse the deep neuromuscular blockade in the experimental group.
15880146|NCT03803969|Device|ConfirmRx (Insertable Cardiac Monitor)|This study is designed to characterise the safety and performance of the ConfirmRx device by assessing quality of signal attained from the device with changes in posture and physical activity at implant and 30days post procedure. The study is also intended to assess gross migrations of the device at 30days post implant.
15880147|NCT03803956|Device|Active PBMT|The PBMT will be performed using the dose of 10J per diode, previously determined by a previous study and power output of 100 mW per diode, also previously determined. PBMT will be performed at nine different sites of the knee extensor muscles, six different sites of the knee flexor muscles and two different sites of the plantar flex muscles. As the cluster will be 5 diodes and 17 different sites will be irradiated, a total of 85 points will be irradiated in each lower limb, a total of 850 J of energy. The active PBMT will be performed before a progressive running test.
15880148|NCT03803956|Device|Placebo PBMT|The placebo PBMT will per performed using the dose of 0 J per diode. Placebo PBMT will be performed at nine different sites of the knee extensor muscles, six different sites of the knee flexor muscles and two different sites of the plantar flex muscles. As the cluster will be 5 diodes and 17 different sites will be irradiated, a total of 85 points will be irradiated in each lower limb, a total of 0 J of energy. To ensure blinding, the device emitted the same sound regardless of the programmed mode (active or placebo PBMT). The placebo PBMT will be performed before a progressive running test.
15880149|NCT03803943|Behavioral|Parent-Implemented Communication Intervention (PICT)|Weekly hour long intervention sessions for 6 months
15880150|NCT03803943|Other|No Intervention - Business-as-usual control|Does not receive PICT internvention
15880151|NCT03803930|Device|Using 22G FNB, the first pass is SP|Using 22G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.
15880152|NCT03803930|Device|Using 22G FNB, the first pass is MWST|Using 22G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.
15880153|NCT03803930|Device|Using 20G FNB, the first pass is SP|Using 20G FNB, the first pass is SP and the pass sequence is SP-MWST-SP-MWST.
15880154|NCT03803930|Device|Using 20G FNB, the first pass is MWST|Using 20G FNB, the first pass is MWST and the pass sequence is MWST-SP-MWST-SP.technique-slow pull.
15880155|NCT03803917|Procedure|Injection with freshly collected autologous adipose tissue|
15880156|NCT03803904|Other|Spin|The intervention will take place three times a week for 12 weeks and will be led by a qualified instructor (an Exercise Physiologist with five years of experience conducting the intervention). The duration of each session will be increased by 1-2 minutes to a maximum time of 45 minutes per session based on the progression of the participants and the recommendation of the instructor. Because participants are initially sedentary and detrained, exercise intensity will begin at low levels (50% of maximal heart rate reserve, HRR) but will be increased by 5% every week (if deemed necessary by the instructor) to a maximum of 75% maximal HRR.
15880157|NCT03803891|Procedure|Endoscopic full-thickness resection|Endoscopic full-thickness resection (EFTR) with Over-The-Scope-Clip in colorectal lesions
15880158|NCT03803865|Behavioral|Mindfulness Training|Guided mindfulness meditation and stress management training
15880159|NCT03803865|Behavioral|Reflection and Problem Solving|Guided reflection,problem solving,and analytical thinking training
15880160|NCT03803852|Device|Intraocular Lens Implantation|Implantation of an intraocular lens Rayner RayOne or Alcon Clareon or Hoya Nanex into the capsular bag using an injector, after removing of the human cristalline lens.
15880161|NCT03803839|Drug|Clodronate|
15880162|NCT03803839|Drug|Saline|
15880163|NCT03803826|Device|CRT-D re-programming|"The previously implanted, ineffective CRT-D is reprogrammed under supervision of Trans-Thoracic Echocardiography (TTE) to:
~adjust the atrioventricular interval so that E and A waves do not overlap
~the interventricular interval is subsequently optimized to yield maximum improvement of the sum of longitudinal+radial+circumferential strains."
15880164|NCT03803826|Diagnostic Test|Trans-Thoracic Echocardiography|"This intervention relates to the determination of strains and atrioventricular interval and supplies data for reprogramming the ineffective CRT-D
~Transthoracic echocardiography performed to determine the left ventricular ejection fraction as an outcome measure is not considered intervention here (as it is also performed in the control group and that would cause an error cross-referencing."
15880165|NCT03803800|Other|Classic, progressive endurance training|Moderate intensity endurance training will be performed following a sequence of 5 training sessions every 2 weeks throughout the 12-week intervention. Sessions will include 60min of cycling on a stationary bicycle. Exercise intensity will match 60-80% of the maximal heart rate (HRmax)
15880166|NCT03803800|Other|Periodized exercise training|Throughout the 12-week periodized intervention, subjects will perform four recurrent 3-week cycles of moderate endurance training (week 1,three sessions, 60min/session, 60-80% HRmax), high intensity interval training (week 2, three sessions, 10min/session, 3x20sec supramaximal sprint interspersed with recovery intervals of 2min), and recovery weeks (week 3, one high intense interval session as described above)
15880167|NCT03803800|Dietary Supplement|beta-alanine|Some subjects will receive the ergogenic supplement beta-alanine.
15880168|NCT03803787|Drug|Inhaled budesonide|Patients will use inhaled budesonide (Numark) with space chamber at 400 mcg given twice daily initiating after the first dose of RT and continuing until pneumonitis development or 12 months completed.
15880173|NCT03803748|Device|Eyestil Plus®|• To demonstrate the non-inferiority of Eyestil Plus® compared to Vismed Multi® in terms of clinical performance as detected by a reduction of keratitis lesions objectified by staining tests after 1 month of treatment, in patients with moderate to severe dry eye syndrome with keratoconjunctivitis
15880174|NCT03803722|Device|Eyestil Protection® unidose|to demonstrate the non-inferiority of Eyestil Protection® in terms of performance and safety, when compared to Vismed® in treatment of dry eye disease.
15880175|NCT03803709|Dietary Supplement|inulin|inulin given at different dosis from day 3 to day 20
15880176|NCT03803709|Dietary Supplement|placebo|maltodextrine given at different dosis from day 3 to day 20
15880177|NCT03803696|Behavioral|Enhanced Standard Care|"Baseline data collection, registration and randomization
~Inform primary transplant clinician of sexual dysfunction causing distress
~Receive American Cancer Society sexual educational material"
15880178|NCT03803696|Behavioral|Multimodal Intervention to Address Sexual Dysfunction|"Baseline data collection, registration and randomization
~- 3 Monthly visits with trained study nurse practitioners
~Referral to specialist if
~Psychological etiology
~Sexual Trauma
~Relationship Discord
~Concern for Malignancy or anatomic scarring requiring surgery"
15880179|NCT03803683|Device|mLab App|The mLab App is a web application that uses an image processing algorithm to interpret the results of the OraQuick® In-Home HIV Test.
15880180|NCT03803683|Behavioral|HIV Prevention Information|Youth randomized to the standard of care will be sent an email with links to mobile-optimized online prevention information, including PrEP and HIV testing information that is found on the Centers for Disease Control and Prevention (CDC) website.
15880181|NCT03803683|Device|HIV Home Tests|Youth randomized into this arm will receive OraQuick® In-Home HIV Test.
15880182|NCT03803670|Diagnostic Test|evaluation of cerebrospinal fluid of ALL|We evaluated cerebrospinal fluids of patients with ALL by conventional cytology and by flow cytometry
15880183|NCT03803657|Device|Monitoring of energy expenditure|Continuous monitoring of energy expenditure.
15880184|NCT03803644|Drug|CC-92480|Part 1 dose escalation
15880185|NCT03803644|Drug|CC-92480|CC-92480
15880186|NCT03803605|Biological|VRC07-523LS|VRC07-523LS 40 mg/kg administered intravenously per series (total of 2 infusions administered)
15880187|NCT03803605|Drug|Vorinostat (VOR)|Vorinostat 400 mg administered orally every 72 hours for 10 doses per series (A total of 20 400-mg doses administered)
15880188|NCT03803592|Behavioral|Dyadic MCS program|"In the first 4 weeks, the dyads will attend the center-based FTF sessions. Each session will last for 1.5 hours. In the first 60 minutes, MCS activities (e.g. reality orientation, calculation and drawing) will be led by an occupational therapist. Skills in delivering the MCS activities will also be taught to equip CG with skills in leading the home-based sessions later. CG will leave in the last 30 minutes to attend a psychoeducation group on caregiving (led by social workers) and the PWD will continue the session.
~From week 5 onwards, The home based session (Week 5-15) will be delivered by the CG 3 times weekly at home (30 - 45min/ session).The sessions will be supplemented with weekly telephone follow-up and two FTF sharing sessions held on the 8th and 12th week over the period."
15880189|NCT03803566|Other|Pegboard practice|Practice of the grooved pegboard test
15880190|NCT03803566|Other|Force control practice|Practice performing steady muscle contractions
15880191|NCT03803553|Drug|FOLFIRI Protocol|FOLFIRI cycle will be two weeks (14 days) long, with FOLFIRI administered on Days 1-3. Participants will receive up to 12 two-week cycles (for a total of 24 weeks) of FOLFIRI chemotherapy.
15880192|NCT03803553|Other|ACTIVE SURVEILLANCE|Will be followed with observation and monitoring with imaging, tumor markers, and ctDNA collections
15880193|NCT03803553|Drug|Nivolumab Protocol|Nivolumab cycle will be four weeks (28 days) long, with Nivolumab administered on day 1. Participants will receive up to 12 four-week cycles (for a total of 48 weeks) of Nivolumab treatment.
15880194|NCT03803553|Drug|Encorafenib/Binimetinib/Cetuximab Protocol|Encorafenib/Binimetinib will be taken orally every day and Cetuximab will be administered intravenously on day 1 of each cycle. Cycles are 14 days long. Participants will receive up to 12 two-week cycles (for a total of 24 weeks) of Encorafenib/Binimetinib/Cetuximab.
15880195|NCT03803540|Other|Fecal Microbiota Transplantation|Fecal Microbiota Transplantation via duodenal infusion
15880196|NCT03803527|Procedure|Esophageal String Test|An EST will be performed for a 1hour sampling period on the same day as the scheduled clinic visit. Subjects will be asked to swallow a capsule and the attached EST string will be taped to the cheek with tegaderm tape. At the completion of the 1-hour sampling period, the EST will be removed and it will immediately be processed and cryopreserved for metabolomics profiling.
15880197|NCT03803514|Drug|Recombinant EPO|Beta-epoetin (Recormon, Roche). Dosage was performed according to current recommendations.
15880198|NCT03803501|Other|condensed functional restoration program|The condensed functional restoration program (CFRP) is a complex multidisciplinary intervention proposed as usual care according to international guidelines. The program takes place in our department of rheumatology, 6 hours per day, 1 day a week, for 4 weeks. Patients are included during consultation or Hospitalisation and are in groups of 6 maximum per FRP. The CRFP was developed on the basis of therapeutic patient education programs and physical exercises (Van Wambeke 2017, Desthieux 2014). Three hours per day are devoted to physical exercises which were divided into three periods: warming, stretching, and muscular strengthening. Specific exercises adapted to work circumstances (like manutention) are taught. Muscular strengthening is based on isotonic contraction on fitness devices. Education is based on 1 hour long educative session adapted from back school programs once a week. Educative booklets are also given to the patients.
15880199|NCT03803488|Device|DropSafe safety pen needle|
15880200|NCT03803475|Drug|Ga-68 labeled PSMA-11|Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if there is presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.
15880201|NCT03803475|Device|Positron emission tomography-computed tomography (PET/CT)|Positron emission tomography-computed tomography (PET/CT) is a nuclear medicine technique which combines, in a single gantry, a positron emission tomography (PET) scanner and an x-ray computed tomography (CT) scanner, to acquire sequential images from both devices in the same session
15880243|NCT03803215|Drug|Theophylline|Oral theophylline initially 600 mg bid and then titrated at the maximum tolerated dose
15880244|NCT03803202|Biological|ASP3772|Intramuscular Injection
15880202|NCT03803475|Device|Positron emission tomography-magnetic resonance imaging (PET/MRI)|A PET/MRI scan is a two-in-one test that combines images from a positron emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan in a single session
15880203|NCT03803462|Other|Behçet's disease Overall Damage Index (BODI)|BODI is a tool to document any organ damage that has occurred in patients since the onset of BD. It includes a form and an associated glossary with the definition of the items.
15880204|NCT03803449|Drug|50-200mg propofol|participants in both groups are given standard regimen including 50-200mg propofol.
15880205|NCT03803449|Drug|50ug fentanyl|participants in fentanyl group are given intervention regimen: 50ug fentanyl.
15880206|NCT03803449|Drug|1 mg midazolam|participants in both groups are given standard regimen including 1 mg midazolam.
15880207|NCT03803436|Procedure|Liver transplant|Liver transplant from cadaveric donors
15880208|NCT03803436|Drug|Chemotherapy|mFOLFOX
15880209|NCT03803436|Drug|Chemotherapy|Panitumumab
15880210|NCT03803423|Other|The Donor App|The Donor app is a web-based application that helps transplant candidates tell the candidate's story via social media in the hopes of identifying an appropriate living donor. Sample stories created using the Donor App can be found at www.thedonorapp.com.
15880211|NCT03803410|Procedure|blood test, noninvasive test for liver fibrosis|blood test of HCV serology and virology.noninvasive test including M2BPGi and fibroscan for liver fibrosis
15880212|NCT03803397|Biological|PV-001-DC|Patient-specific cellular therapeutic for cancer immunotherapy
15880213|NCT03803384|Other|Oxygen therapy|Oxygen supply during ESWT, once with the prescribed constant oxygen flow and once using an auto-regulated oxygen flow system setting the SpO2 target at 92%.
15880214|NCT03803371|Drug|Ultracet Tablets|Ultracet tablet (Janssen Cilag Farmacêutica Ltda) equivalent to Tramadol hydrochloride 37.5 mg/Paracetamol 325 mg
15880215|NCT03803371|Drug|Tramadol hydrochloride 37.5 mg/Paracetamol 325 mg tablets - tablet (Pfizer)|Tramadol hydrochloride 37.5 mg/Paracetamol 325 mg tablets (Pfizer)
15880216|NCT03803358|Other|exercise training with non-invasive ventilation|In the intervention group (exercise training with non-invasive ventilation) exercise NIV pressures will be optimally adjusted to each individual patient to decrease TcPCO2 values. An IPAP of at least 15 cmH20 will be used to provide sufficient pressure to relief patients breathing muscles. Nocturnal NIV will be continued.
15880217|NCT03803358|Other|standard exercise training without NIV|In the control Group (standard exercise training without NIV ), patients will be execute cycle exercise without additional NIV (usual care). Nocturnal NIV will be continued.
15880220|NCT03803319|Dietary Supplement|Fibre 1 (combined fibres)|Dietary fibre supplement
15880221|NCT03803319|Dietary Supplement|Fibre 2 (natural fibres)|Dietary fibre supplement
15880222|NCT03803319|Dietary Supplement|Dietary Supplement: placebo|Dietary supplement
15880223|NCT03803306|Combination Product|Vedic Medical Astrology|Individualised astrological based interventions were given including vedic counselling, diet, colors, gems, mantras and the worship deities as an adjuvent to ongoing conventional treatments
15880224|NCT03803306|Other|Placebo vedic medical astrology (PMA)|Conventional treatments were followed with counselling and diet suggestions. astrological interventions were not incorporated during the study phase.
15880225|NCT03803293|Diagnostic Test|Pharmacogenomic testing|A comprehensive PGx interpretive report created by OneOme (www.oneome.com) provides information on how an individual patient's genes may affect medication response. OneOme utilizes algorithms and curated clinical PGx knowledge to generate a highly intuitive personalized report based on a patient's genomic results.
15880226|NCT03803280|Procedure|ERAS program|ERAS pathway according to the Spanish Via RICA
15880227|NCT03803267|Other|Erector spinae plane block|For each side, the eighth thoracic transverse process will be identified by a linear US transducer (HFL38_10-5 MHz), puncture will be performed in the plane in the craniocaudal direction until the needle contacts the transverse process, and 20 ml of bupivacaine 0.25% and 4 mg dexamethasone will be injected visualizing the hydrodissection. After 30 minutes, the degree of sensory block in the trunk will be assessed by the pinprick test and any undesirable motor weakness will be recorded as a side effect.
15880228|NCT03803267|Other|Quadratus lumborum block|For each side, shamrock sign with three leaves (psoas major muscle anteriorly, the erector spinae muscle posteriorly and the quadratus lumborum muscle adherent to the apex of the transverse process of the L4 vertebral body) will be identified by a curved array US transducer (6-2MHz), puncture will be performed in-plane, the needle will be advanced through the quadratus lumborum muscle penetrating the ventral proper fascia of the quadratus lumborum muscle, and 20 mL of bupivacaine 0.25% and 4 mg dexamethasone will be injected in that space visualizing the hydrodissection. After 30 minutes, the degree of sensory block in the trunk will be assessed by the pinprick test and any undesired motor weakness will be recorded as a side effect
15880229|NCT03803267|Drug|Propofol|Propofol (2 mg/kg)
15880230|NCT03803267|Drug|Fentanyl NCS|Fentanyl (1µg/Kg)
15880231|NCT03803267|Drug|Atracurium Injectable Product|atracurium (0.5mg/kg)
15880232|NCT03803267|Other|Endotracheal intubation|endotracheal intubation
15880233|NCT03803267|Drug|Anesthesia Maintenance|Inhalational isoflurane in oxygen/air mixture
15880234|NCT03803267|Drug|Muscle Relaxation|atracurium boluses (0.2 mg/Kg/20 minutes) will be used for maintenance of general anesthesia
15880235|NCT03803254|Procedure|Hepatic arterial infusion chemotherapy|administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
15880236|NCT03803254|Drug|Folfox Protocol|Oxaliplatin , fluorouracil, and leucovorin
15880237|NCT03803254|Drug|Lenvatinib|12 mg (or 8 mg) once daily (QD) oral dosing.
15880238|NCT03803254|Drug|PD-1 antibody|3mg/kg intravenously every 2 weeks
15880239|NCT03803241|Drug|CD133+ infusion|Infusion of cells cd133+
15880240|NCT03803241|Other|portal vein embolization|portal vein embolization
15880241|NCT03803228|Drug|DUOSTIM|2 consecutive stimulations by Fertistartkit® on the same cycle
15880242|NCT03803228|Drug|Conventional stimuli|2 stimulations by Fertistartkit® performed on 2 different cycles
15880245|NCT03803202|Biological|PCV13|Intramuscular Injection
15880247|NCT03803189|Behavioral|Usual care plus eToolkit|The intervention arm will receive repeated e-surveys via email to collect the Edinburgh Postpartum Depression Scale (EPDS) score at baseline and 2, 4, 6, 8, and 12 weeks. Those with EPDS<10 will be triaged as low risk. Those with EPDS 10-18 (without suicidality) will be triaged as symptomatic for non-urgent clinical assessment with a message delivered via the EMR. Those with EPDS≥19 or suicidality will be triaged as requiring immediate follow-up, with an urgent message to their PCP via EMR, phone (if suicidal) and fax. Prompts in the EMR will enable evidence-based clinical care for PPD and PPA, highlight treatment preferences to support shared decision making, and identify appropriate referrals. Intervention arm participants will receive a personalized eToolkit after the completion of each survey. Patients in the intervention group with symptoms will be invited to a telephone interview at 12 weeks postpartum to describe their experience with the intervention.
15880248|NCT03803176|Procedure|Open Flap Debridement|Full thickness flaps are elevated to fully expose the periodontaldefects. Defects are then fully debrided and the roots are carefully planned. Flaps are repositioned and sutured to obtain primary closure of the interdental space. This will be done for chronic periodontitis patients
15880249|NCT03803163|Drug|TransCon Treprostinil|
15880250|NCT03803150|Procedure|PRA approach|A preauricular incision will be made that extends downwards in a curvilinear fashion in the cervicomastoid skin crease, though any variation in this incision will suffice. The great auricular nerve will be preserved and the flap raised in the subdermal fat plane, superficial to the superficial musculoaponeurotic layer to allow access to the masseter adjacent to the anteroinferior edge of the parotid gland, just below the parotid duct. Branches of the facial nerve will be readily identified and avoided with or without loupe magnification, on the surface of the masseter muscle.
15880251|NCT03803150|Procedure|RT approach|The incision for the retromandibular approach begins 5mm below ear lobe and continues 3 to 3.5cm inferiorly. Initial incision begins through skin and subcutaneous tissues,platysma muscle ,(SMAS), parotid capsule Dissection is continued until the only tissue remaining on the posterior border of the mandible will be the periosteum of pterygomassetric sling,then the fracture site will exposed and reduced.
15880252|NCT03803137|Other|VOC analysis|VOC analysis in exhaled air with e-noses and mass spectrometry
15880253|NCT03803124|Drug|Tolvaptan|1 tablet before renography
15880254|NCT03803124|Drug|Placebo|1 tablet before renography
15880255|NCT03803111|Behavioral|Initial exercise training|Initial exercise training program
15880256|NCT03803111|Drug|Initial FCM|Initial intravenous iron supplementation (FCM)
15880257|NCT03803111|Drug|Subsequent FCM|Subsequent intravenous iron Supplementation (FCM) after 2 months
15880258|NCT03803111|Behavioral|Subsequent exercise training|Subsequent exercise training program after 2 months
15880259|NCT03803098|Device|reference measure|measure of a physiological parameter performed with the gold standard medical device
15880260|NCT03803098|Device|alternative measure|measure of a physiological parameter performed with the connected device under evaluation
15880261|NCT03803085|Behavioral|Control condition|Participants in the control group only saw their own daily walking steps using the WeChat. They did not use WeChat to see other group members' daily steps and did not contact other group members. The participants were asked to use the app every day. A message (through WeChat) was sent to remind them to use the application if they had not done so within three days.
15880262|NCT03803085|Behavioral|Treatment condition|Participants in the experimental condition used WeChat for 4 weeks to see their own and other's walking steps and also were able to contact other group members. The participants were asked to use the application every day. A message (through the group chat) was sent to remind them to use the application if they have not done so within three days.
15880263|NCT03803072|Behavioral|time restricted eating (TRE)|Participants will attend a face-to-face meeting with the researchers at the last day of the first week of data collection (habitual diet and physical activity period) where they will be counselled to consume all food and fluid within a 8-10 h time window of their choice starting no later than 09.00 h for five weeks. During the intervention period, they will be counselled by weekly phone calls to provide encouragement, support and monitoring to improve adherence to the TRE window.
15880264|NCT03803059|Device|SkinPen Precision|Surgical instrument motors and accessories/attachments/Hydrogel
15880265|NCT03803033|Other|Clinical pharmacy-based home medication management review service|A baseline interview by the clinical pharmacist was conducted with patients at their homes to assess their use of treatment and to collect all relevant information needed to identify TRPs. Upon TRP identification at baseline, the clinical pharmacist generated a written report of findings and recommendations, which was delivered directly to the patient's physician in a sealed envelope. Patients were asked to refer back to their physicians if they required confirmation of any changes in treatment. Physicians maintained the blinding of patients with regard to whether changes were based on recommendations by the pharmacist. In both the intervention and the control groups, the clinical pharmacist performed a follow-up interview with patients 3 months after the initial interview, during a regular follow-up visit to their physician at the hospital. Assessments in the follow-up interview, regardless of the study group, involved changes in treatment and number of TRPs.
15880266|NCT03803020|Other|fractional flow reserve and SPECT detection|fractional flow reserve and SPECT detection
15880267|NCT03803007|Drug|Intravenous ACT017 1000 mg|Add-on therapy to the standard of Care in the treatment of the acute ischemic stroke symptoms
15880268|NCT03803007|Other|Intravenous Placebo|Add-on therapy to the standard of Care in the treatment of the acute ischemic stroke symptoms
15880269|NCT03802994|Drug|23 valent pneumococcal polysaccharide vaccine|FDA approved pneumococcal polysaccharide vaccine containing capsular polysaccharide of 23 different pneumococcal serotypes. Only group 5 will potentially receive this as an intervention.
15880270|NCT03802994|Biological|13 valent conjugated pneumococcal vaccine|FDA approved pneumococcal polysaccharide vaccine containing capsular polysaccharide of 13 different pneumococcal serotypes conjugated to CRM197. Only group 5 will receive this as an intervention. In all other groups Prevnar 13 will be given as standard of care.
15880302|NCT03802682|Drug|Apalutamide|Participants will receive apalutamide 240 mg as a whole tablets administered orally (Treatment A) or as a dispersed mixture in applesauce (Treatment B) under fasted condition.
15880303|NCT03802669|Other|oral mutans streptococcus|quantitative assessment of mutans streptococcus of each group by using PCR and protein pattern
15881848|NCT03790787|Drug|Dorzagliatin|Glucokinase activator currently under development
15880271|NCT03802994|Other|Peripheral blood sample|Peripheral blood samples (30-60 mL) will be collected at day 0 (pre-immune), day 7, and day 30 (4 weeks post-PPV23) for groups 1-4 and at days 366, 373 and 396 for group 5. In addition, day 5, and 10 blood samples will be obtained from a limited (n=10) number of elderly RT participants to determine the optimal time point for circulation of PPS-specific B cells. Yearly blood samples will be obtained thereafter for serum antibody and OPA analyses to test longevity of antibody and OPA responses. Samples obtained from days 0, 30 and yearly samples will be used for antibody titers and opsonophagocytic assays. Samples from day 0 (day of vaccination with PCV13) and day 7 will be used for flow cytometric analysis.
15880272|NCT03802955|Drug|ADG106|IV infusion over 60 minutes on Day 1 of each cycle, at 7 doses depending on cohort at enrollment.
15880273|NCT03802942|Dietary Supplement|Glucerna|1 bottle in the morning with breakfast and 1 bottle in the evening with dinner
15880274|NCT03802916|Drug|Deferiprone DR tablets 1000 mg (Low dosage)|Deferiprone DR tablets 1000 mg
15880275|NCT03802916|Drug|Deferiprone DR tablets 1000 mg (High dosage)|Deferiprone DR tablets 1000 mg
15880276|NCT03802903|Device|Remo-Wax|topical treatment
15880277|NCT03802877|Behavioral|Resource bank|See intervention arm descriptions
15880278|NCT03802877|Behavioral|ePlatform|See intervention arm descriptions
15880279|NCT03802877|Behavioral|Health coach|See intervention arm descriptions
15880280|NCT03802864|Drug|Liposomal Bupivacaine|After surgical sperm retrieval, the wound will be injected with liposomal bupivacaine (266 mg) mixed with standard bupivacaine (bupivacaine hydrochloride 50mg) for post-operative pain relief.
15880281|NCT03802864|Drug|Standard Bupivacaine|After surgical sperm retrieval, the wound will be injected only with standard bupivacaine (bupivacaine hydrochloride 100mg) for post-operative pain relief.
15880282|NCT03802851|Procedure|Holmium Laser Enucleation of Prostate (HoLEP)|Holmium laser enucleation of the prostate (HoLEP) is a surgical treatment use for men with bothersome lower urinary tract symptoms (LUTS) to improve their LUTS. During the procedure a thin telescope-like instrument is inserted into the urethra. The high-powered laser is then inserted through this instrument and used to carefully remove the excess prostate tissue that is causing obstruction of the urethra and contributing to the patient's lower urinary tract symptoms.
15880283|NCT03802838|Device|acupuncture|Schizophrenia with negative symptoms were treated with Amisulpride, and the patients still remained negative symptoms and cognitive impairment.Amisulpride is allowed in a dose range of 50-1200 mg / d, once or twice a day for at least 12 weeks. These patients were combined with acupuncture. Acupuncture points include:'Yintang', 'Shenting', 'Taiyang', 'Jingming', 'Zanzhu', 'Yuyao', 'Jiaosun', 'Baihui', 'Fengchi', 'Anmian'.
15880284|NCT03802838|Drug|Amisulpride|Schizophrenia with negative symptoms were treated with Amisulpride, and the patients still remained negative symptoms and cognitive impairment.Amisulpride is allowed in a dose range of 50-1200 mg / d, once or twice a day for at least 12 weeks.
15880285|NCT03802825|Behavioral|Diabetes Self-Management Training|The Decision-making Education for Choices in Diabetes Everyday (DECIDE) program is a nine-module, literacy adapted diabetes and cardiovascular disease education and problem-solving training program. Participants are taught the five steps of problem solving with each module going in depth on a single step: 1) identify the problem; 2) brainstorm possible strategies for problem resolution; 3) select the most appropriate strategy; 4) apply the strategy; 5) evaluate the effectiveness of the strategy. During the six months, CHWs will have weekly or bi-weekly contract with participants in-person or by phone to deliver the DECIDE modules and address social and economic needs.
15880286|NCT03802825|Other|Standard Patient Navigation|Once the participant has completed the YCLS assessment with study staff, the navigator will receive the referral and follow-up with the participant to address the social and economic needs identified. The patient navigator will follow-up with the participant 2-3 times over the 6 months by phone or in-person about progress with the referral and help address additional needs that may develop during the 6-month intervention.
15880287|NCT03802812|Device|Thin bronchoscope and VBN|targeted washing at more adjacent TB lesion using thin bronchoscope and virtual bronchoscopic navigation system
15880288|NCT03802799|Drug|ZYN002 - CBD Transdermal Gel|Pharmaceutically manufactured. Cannabidiol (CBD) formulated as a clear gel (transdermal delivery)
15880289|NCT03802786|Drug|Imeglimin|Single administration dose of imeglimin
15880290|NCT03802773|Procedure|CB transplantation|Myeloablative conditioning with post-transplant cyclophosphamide in patients receiving a matched CB transplant for hematological malignancies.
15880291|NCT03802760|Device|Transcranial Doppler (TCD) ultrasound measurement|Non-invasive measurement of cerebral embolic load and blood flow using TCD
15880292|NCT03802747|Drug|Durvalumab|Durvalumab will be dosed at 1500 mg fixed dosing every 4 weeks and continued at this interval until progression or dose-limiting toxicity.
15880293|NCT03802747|Drug|Durvalumab and Tremelimumab|Durvalumab will be dosed at 1500 mg fixed dosing every 4 weeks and continued at this interval until progression or dose-limiting toxicity. Tremelimumab will be dosed at 75 mg every 4 weeks (same day as durvalumab infusion) for a maximum of 4 doses.
15880294|NCT03802747|Drug|Y-90 Selective Internal Radiation Therapy (SIRT)|Yttrium-90 microsphere therapy consists of resin beads loaded with Yttrium, a pure beta emitter with a 64.2 hour half-life. Radioembolization will be performed as standard of care therapy per current NCCN guidelines.
15880295|NCT03802747|Drug|Stereotactic Body Radiation Therapy (SBRT)|High-dose hypofractionated conformal external beam radiation therapy that is considered a standard of care. SBRT will also be considered for metastases that are persistent and/or progressive after Y-90 based on MR imaging and pathology from tissue biopsies.
15880296|NCT03802734|Device|Mindful meditation phone app|Participants in the intervention group will be given a free 6-month subscription to a mindful meditation phone app (Headspace). They will also be given an actigraph and a general pregnancy and sleep information leaflet.
15880297|NCT03802721|Drug|[14C]-benzo[a]pyrene|Oral micro-dose (50 ng) (5.4 nCi)
15880298|NCT03802721|Drug|Brussels sprouts before 50 ng dose|Brussels sprouts for 7 days before 50 ng (5.4 nCi) dose of BaP
15880299|NCT03802721|Drug|DIM supplement before 50 ng dose|DIM supplement for 7 days before 50 ng (5.4 nCi) dose of BaP and coadministration with DIM supplement
15880300|NCT03802708|Diagnostic Test|Metabolomic analysis urine sample|a urine sample will be anlayzed for metabolic pathways involving Nitric Oxide Nitric Oxide level will be measured at the exhaled air sample
15880301|NCT03802695|Biological|OrcaGraft (Orca-Q)|engineered donor allograft
15880304|NCT03802656|Device|Anterior Vertebral Body Tethering|Vertebral body tethering through anterior thoracoscopic approach under general anesthesia and fluoroscopic guidance.
15880305|NCT03802630|Drug|Brolucizumab 6 mg|Solution for injection (intravitreal use)
15880306|NCT03802630|Drug|Aflibercept 2 mg|Solution for injection (Intravitreal use)
15880307|NCT03802630|Other|Sham injection|Empty sterile syringe without a needle administered as a sham injection for masking purposes
15880308|NCT03802617|Drug|MR13A9|Intravenous administration
15880309|NCT03802617|Drug|Placebo|Intravenous administration
15880310|NCT03802604|Biological|Talimogene laherparepvec|Talimogene laherparepvec will be given via intra-tumoral injection at an initial dose of 10^6 PFU/mL. On week 3 (i.e. 21 days [± 2] days), a second talimogene laherparepvec injection will be administered at a dose of 10^8 PFU/mL. Third, fourth and fifth injections will be administered every 2 weeks (every 14 [± 2] days). The maximum volume for each injection will be 4.0 mL.
15880311|NCT03802604|Drug|Atezolizumab|Atezolizumab 840 mg will be administered by IV infusion on Day1 week 3, then every 2 weeks (every 14 [± 2] days), for a total of 4 treatment courses.
15880312|NCT03802591|Drug|CS1001 monoclonal antibody|Participant will receive CS1001 monoclonal antibody by intravenous infusion every 3 weeks(Q3W), for up to 24 months
15880313|NCT03802591|Drug|CS1001 placebo|Participant will receive CS1001 placebo antibody by intravenous infusion every 3 weeks(Q3W), for up to 24 months
15880314|NCT03802591|Drug|Oxaliplatin|Administered as an IV infusion on Day 1 Q3W
15880315|NCT03802591|Drug|Capecitabine|Administered by oral, twice a day on Day 1 - Day 14 of each cycle.
15880316|NCT03802578|Behavioral|HAND EXERCISE|
15880317|NCT03802565|Drug|Tolperisone|TID
15880318|NCT03802565|Drug|Placebo|Placebo
15880319|NCT03802552|Drug|Cefadroxil|oral one-time dose of cefadroxil
15880320|NCT03802552|Drug|Cephalexin|oral one-time dose of cephalexin
15880321|NCT03802539|Device|Glass Liner|restoration of root caries according to two different protocols
15880322|NCT03802526|Drug|NVP-1805-R1|1 tablet, multiple oral dosing
15880323|NCT03802526|Drug|NVP-1805-R2|1 tablet, multiple oral dosing
15880324|NCT03802526|Drug|NVP-1805-R1 and NVP-1805-R2|NVP-1805-R1,1 tablet and NVP-1805-R2, 1 tablet, co-administration, multiple oral dosing
15880325|NCT03802513|Other|Physical Therapy|Individualized physiotherapy including exercises to be performed by the Veteran at home.
15880326|NCT03802500|Diagnostic Test|Nerve conduction study|"Physical examination of muscle strength is conducted using the Medical Research Council (MRC) scale in 6 muscles bilaterally.
~Patients with an MRC score of less than 48 of 60 are diagnosed with critical illness polyneuromyopathy (CIPNM).
~The evaluation is completed by a routine neurological examination. In patients meeting the inclusion criteria, the screening Peroneal nerve test (PENT test) is performed on the day of study enrollment and subsequently in 1 week intervals until pathologic findings are detected or patient is discharged from the ICU.
~PENT measures the peroneal nerve Compound muscle action potential (CMAP) amplitude in one leg. If the PENT is normal, the contra-lateral peroneal nerve is measured. An abnormal condition is identified if the peroneal nerve CMAP amplitude is reduced below the normal limits of the participating centre in at least one leg. In Lausanne, the abnormal response is < 2,5 mV."
15880327|NCT03802487|Drug|Sotagliflozin (SAR439954)|"Pharmaceutical form: Tablet
~Route of administration: Oral"
15880328|NCT03802487|Drug|14C-microtracer|"Pharmaceutical form: Solution for injection
~Route of administration: Intravenous"
15880329|NCT03802487|Drug|Charcoal|"Pharmaceutical form: Granules for suspension
~Route of administration: Oral"
15880330|NCT03802461|Biological|Fecal Microbiota Transplantation (FMT)|Feces from healthy donor
15880331|NCT03802448|Combination Product|Study group|"Each pregnant woman in the study group received myofascial release technique, 3 sessions/week for 4 weeks. a myofascial release in addition to wearing a natural wrist splint during sleeping for 4 weeks.
~Myofascial wrist retinaculum (Transverse carpal ligament) release.
~• Second part; Interosseous membrane and forearm muscles myofascial release (Bilateral thumb pressure technique)."
15880332|NCT03802448|Device|Control group|A neutral wrist splint was worn by all pregnant women in both groups daily at night, only all through the study time (4 weeks). This neutral wrist splint was used to keep the wrist in a straight position (neutral position) and to prevent the extreme wrist motion (flexion and extension) while sleeping.
15880333|NCT03802435|Procedure|two-sessions of ultrasound-guided PIT|two-sessions of ultrasound-guided PIT with 10cc D5W (3 months interval)
15880334|NCT03802435|Procedure|One-sessions of ultrasound-guided PIT|One-session of ultrasound-guided PIT with 10cc D5W and 10cc normal saline separately (3 months interval)
15880335|NCT03802435|Procedure|Placebo ultrasound-guided injection with nerve hydrodissection|Two-sessions of ultrasound-guided PIT with nerve hydrodissection with 10cc normal saline (3 months interval).
15880336|NCT03802422|Drug|Vitamin B12|Ultrasound-guided hydrodissection with 3cc Vitamin B12 (methycobal, 500μg/ml) between carpal tunnel and median nerve.
15880337|NCT03802422|Drug|Normal saline|Ultrasound-guided hydrodissection with 3cc 0.9% normal saline between carpal tunnel and median nerve.
15880338|NCT03802396|Drug|CN-105|"Three doses of CN-105 will be used in three successive cohorts of 67 patients each (50 receiving drug and 17 receiving placebo) 0.1 mg/kg (cohort 1) 0.5 mg/kg (cohort 2)
~1 mg/kg (cohort 3)
~The study drug will be administered by IV every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses."
15880339|NCT03802396|Drug|Placebo|Patients will receive placebo intravenously every 6 hours, beginning 1 hour prior to surgery, until postoperative day 3 or hospital discharge, whichever occurs first, up to a maximum of 13 doses, identical to those receiving the study drug.
15880340|NCT03802370|Procedure|connective tissue grafting by Dome Technique|The dome technique addresses the placement of the CT, as it is layered over the implant and takes the shape of an inverted dome
15880341|NCT03802357|Procedure|Exercise training|Patients perform an exercise Training program of 3 weeks Duration including endurance Training, resistance Training and squat Training. This program is part of an inpatient pulmonary Rehabilitation.
15880342|NCT03802344|Drug|MC2-01 cream|MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%) cream
15880343|NCT03802344|Drug|Cal/BDP combination|Calcipotriene/betamethasone dipropionate, w/w 0,005%/0,064%
15880344|NCT03802344|Drug|Vehicle|Vehicle cream
15880346|NCT03802318|Drug|Rabeprazole|Rabeprazole daily four time (Bid) or daily four times (Qid) Amoxicillin used daily two times (1000 mg bid) or daily four times (500 mg qid) apply in the first line or the second line H pylori eradication therapy
15880347|NCT03802305|Device|computerized intraosseous technique (Quicksleeper™)|"The anesthetic solution is administered with a specific equipment allowing the injection step by step:
~anesthesia of the interdental papilla,
~positioning of the needle and perforating of the interdental space,
~Injection of the solution. All of these steps are based on an adjustment of the different part of this equipment."
15880348|NCT03802305|Device|loco-regional anesthesia (IANB technique)|The anesthetic solution is delivered by a needle near to the inferior alveolar nerve before it enters the mandibular foramen.
15880349|NCT03802292|Biological|YQ23|Single dose of YQ23 delivered via intravenous route. Ascending dose levels will be evaluated
15880350|NCT03802292|Biological|Matching Placebo|Single dose of the matching placebo delivered via intravenous route.
15880351|NCT03802279|Other|Effort test|"Cardiac function:
~Echocardiography: left ventricular ejection fraction and global longitudinal strain will be measured.
~Cardiopulmonary exercise test (CPET): left ventricular stroke volume was assessed noninvasively using a thoracic bioelectrical impedance device : maximal stroke volume at the peak of effort will be considered.
~Peripheral muscle function:
~CPET: Oxygen uptake (VO2) (and carbon dioxide) output are measured. The slope of the relationship (dQ/dVO2) will be calculated between cardiac output (Q) and VO2 using measurements of Q (using measure of the stroke volume by thoracic bioelectrical impedance device) and VO2 at rest as well as during submaximal and maximal exercise
~Muscle oxygenation is measured using a near-infrared spectroscopy device.
~VO2 et Q will be measured : dQ/dVO2 is high in case of oxydation defect; If Q is low because of a concommittant cardiac impairement, the DAV = VO2/Q, and DO = (Q x DAV) / (200 - DAV) will be calculated."
15880352|NCT03802279|Other|Functional tests on fibroblasts|Functional tests performed on fibroblasts in primary culture, using as tracers of stable isotope-labeled substrates. The metabolites of interest are assayed in mass spectrometry.
15880353|NCT03802266|Device|Electromagnetic Navigation guided transthoracic needle aspiration|Patients in this group will receive electromagnetic navigation guided transthoracic needle aspiration for the diagnosis of pulmonary peripheral nodule
15880354|NCT03802266|Device|CT-guided Transthoracic Needle Aspiration|Patients in this group will receive CT guided transthoracic needle aspiration for the diagnosis of pulmonary peripheral nodule
15880355|NCT03802253|Behavioral|Time Restricted Feeding(TRF)|Participants will receive a diet of 1200-1500kcal/d and be instructed to eat only during a window of 8 hours (Finishing the last meal before 4pm) in the first 6 months. 6 months later, Participants will receive a diet of 1200-1500kcal/d without a restriction of feeding time.
15880356|NCT03802253|Behavioral|Reduced Calorie Diet (RCD)|Participants will receive a diet of 1200-1500kcal/d and keep their usual eating pattern.
15880357|NCT03802240|Drug|Sintilimab|200mg IV Q3W
15880358|NCT03802240|Drug|IBI305|15mg/kg IV Q3W
15880359|NCT03802240|Drug|Pemetrexed|500mg/m2 IV Q3W
15880360|NCT03802240|Drug|Cisplatin|75mg/m2 IV Q3W
15880361|NCT03802240|Drug|Placebo1|Placebo1 IV Q3W
15880362|NCT03802240|Drug|Placebo2|Placebo2 IV Q3W
15880363|NCT03802227|Drug|NKTR-181|A combination of NKTR-181 and oxycodone IR placebo
15880364|NCT03802227|Drug|Oxycodone IR|A combination of oxycodone IR and NKTR-181 placebo
15880365|NCT03802214|Drug|Vedolizumab|standard vedolizumab induction (300mg IV at week 0, 2, 6)
15880366|NCT03802201|Drug|PTG-300|Subcutaneous (SC)
15880367|NCT03802162|Drug|CKD-355A (D797/Memantine HCl 20mg)|once a day
15880368|NCT03802162|Drug|CKD-355B (D797/Memantine HCl 20mg)|once a day
15880369|NCT03802162|Drug|D797|once a day
15880370|NCT03802162|Drug|D324 (Memantine HCl 10mg)|twice a day
15880371|NCT03802149|Drug|Ulipristal Acetate|90mg Ulipristal Acetate 18-24-hours prior to dilation and evacuation
15880372|NCT03802123|Drug|⁸⁹Zr-Df-IAB22M2C|⁸⁹Zr-Df-IAB22M2C CD8 T cell tracer for Positron Emission Tomography (PET)
15880373|NCT03802110|Device|commercially released subcutaneous implantable cardioverter defibrillator (S-ICD) and the Investigational S-ICD Adapter.|The S-ICD System is a Subcutaneous (under the skin) Implantable Cardioverter Defibrillator for people who are at risk of Sudden Cardiac Arrest. A new electrode configuration will be tested for Defibrillation testing ( DFT). The unit of measure will be in Joules. VF will be induced and the device will deliver a shock at a certain defined energy level as described in the protocol
15880374|NCT03802097|Drug|No antimicrobial prophylaxis|Do not use of prophylactic antimicrobial for the patients with undergoing totally laparoscopic distal gastrectomy with D1 or D1+ lymphadenectomy for the gastric cancer
15880375|NCT03802084|Drug|vactosertib/imatinib combination|"Phase 1 : Imatinib 400mg QD P q28days Vactosertib 1 cohort 200mg bid (D1-5, 8-12, 15-19, 22-26)
~1 cohort 100mg bid Phase 2 : Imatinib 400mg QD PO q28days. Vactosertib RP2D, bid (D1-5, 8-12, 15-19, 22-26)"
15880376|NCT03802071|Drug|Durvalumab+doxorubicin cobination|Durvalumab 1500mg IV Doxorubicin 75mg/m2 IV D1 Q3weeks (up to 8cycles)
15880377|NCT03802058|Drug|Nab-paclitaxel|Nab-paclitaxel 40mg/m2 for Injection weekly
15880378|NCT03802058|Drug|Carboplatin|Carboplatin AUC=2 for Injection weekly
15880379|NCT03802058|Radiation|Thoracic radiation therapy|Thoracic radiation therapy 60-66Gy/30-33 fractions,both three-dimensional conformal and intensity modulated radiation therapy are allowed
15880380|NCT03802045|Procedure|Electroacupuncture|"The interventions will be performed by acupuncture specialists with at least 3 years of clinical experience, who will receive prior training to ensure that they rigorously follow the study protocol and are familiar with the types of treatments, including details such as acupuncture points and manipulation of electroacupuncture parameters.
~After the randomization, the acupuncturist will sequentially open the envelopes, and the individuals will be randomly assigned to one of five treatment groups: Low frequency EA (LF), high frequency EA (HF), alternating frequency EA (AF), control group (C) and placebo group (P), each containing 25 participants. The acupuncture points will be located and described according to the WHO Standard Acupuncture Locations. Based on the beneficial effects of previous clinical trials, the acupoints selected for this study will be: BL23, BL25, BL40, SP6 and KI3."
15880381|NCT03802045|Device|Needle|Sterile and disposable 0.25mm x 30mm stainless steel needles (Dong Bang Acupuncture Inc., Seoul, Korea) will be used.
15880382|NCT03802045|Device|Adhesive Moxa|In the placebo group an adhesive moxa will be placed on each acupoint and the needle will be inserted over it.
15880385|NCT03802019|Other|LNC Cigarettes + Colored Packaging|After completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive low nicotine content cigarettes in one of four types of packaging: gray, red, blue, or plain.
15880386|NCT03802019|Other|Own Brand|After completing a 5-day baseline period of smoking their own brand, participants will be randomized to a 30-day experimental period when they will receive their own preferred brand of cigarette (i.e., control).
15880387|NCT03802006|Diagnostic Test|Ultrasound assessment of gastric content|Ultrasound assessment of gastric body is performed
15880388|NCT03801980|Drug|SK-1403|Patients receive SK-1403 three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment.
15880389|NCT03801980|Drug|Placebo|Patients receive Placebo three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (24 weeks), with individual dose adjustment.
15880390|NCT03801967|Drug|AZD9977|Randomized participants will receive oral dose of AZD9977.
15880391|NCT03801967|Drug|Placebo|Randomized participants will receive oral dose of matching placebo.
15880392|NCT03801954|Behavioral|Educational Videos|15 videos that are about 3 minutes long each and cover nutritional advice for patients with bladder cancer undergoing RC and/or chemotherapy.
15880393|NCT03801941|Device|wearing ATLAS device during evaluation at 4th day|Wearing the ATLAS device 60 min per day during 5 days and evaluation of pain during standardized activities with or without ATLAS Device at the 4th or 5th day of a 4 weeks rehabilitation program.
15880394|NCT03801941|Other|wearing ATLAS device during evaluation at 5th day|Wearing the ATLAS device 60 min per day during 5 days and evaluation of pain during standardized activities without ATLAS Device at the 4th or 5th day of a 4 weeks rehabilitation program.
15880395|NCT03801928|Drug|Inflectra|The study plans to recruit 300 subjects in the United States and Canada initiating or switching to treatment with INFLECTRA over an 8 month period. The decision to start INFLECTRA will be entirely a clinical decision made by the participating physician irrespective of this study.
15880396|NCT03801915|Drug|MVT-5873|1 mg/kg or 3 mg/kg for pre-operative dose, 1 mg/kg during post-operative period
15880397|NCT03801915|Procedure|pancreatectomy or hepatectomy|Pancreatectomy or hepatectomy
15880398|NCT03801902|Biological|Durvalumab|Given IV
15880399|NCT03801902|Radiation|Fractionated Stereotactic Radiation Therapy|Undergo conventionally fractionated radiation therapy
15880400|NCT03801902|Radiation|Hypofractionated Radiation Therapy|Undergo ACRT
15880401|NCT03801889|Drug|SP-420|Self-administered by mouth
15880402|NCT03801876|Drug|Carboplatin|Given IV
15880403|NCT03801876|Procedure|Esophagectomy|Undergo esophagectomy
15880404|NCT03801876|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
15880405|NCT03801876|Drug|Paclitaxel|Given IV
15880406|NCT03801876|Radiation|Proton Beam Radiation Therapy|Undergo PBT
15880407|NCT03801876|Other|Quality-of-Life Assessment|Ancillary studies
15880408|NCT03801876|Other|Questionnaire Administration|Ancillary studies
15880409|NCT03801876|Drug|FOLFOX regimen|Folinic acid, flurouracil and oxaliplatin
15880410|NCT03801876|Drug|CAPOX regimen|Capecitabine combined with oxaliplatin
15880411|NCT03801876|Drug|Docetaxel|Chemotherapy
15880412|NCT03801876|Drug|5FU|Chemotherapy
15880413|NCT03801863|Procedure|Ultrasound-guided Erector Spinae Plane Block with Ropivacaine 0.375%|Ultrasound-guided Erector Spinae Plane Block will be done at L4 interspace. Ropivacaine 0.375% will be used.
15880414|NCT03801863|Drug|Ropivacaine|Using 0.375% Ropivacaine in the nerve block
15880415|NCT03801850|Device|3D surface scan|measurement of inter fractional deformations by surface scanning
15880416|NCT03801837|Dietary Supplement|Macadamia Nut|Participants will be provided with the appropriate portion of macadamia nuts [15% of daily calories or 30-45 grams based on kcal requirement of the individual]
15880417|NCT03801837|Dietary Supplement|Control Diet|Participants will continue with their Habitual Diet during this part of the intervention
15880418|NCT03801824|Other|Standard Nutrition Therapy|Subjects will be advised on standard diet appropriate for the management of Gestational Diabetes Mellitus (GDM) designed to be high in fiber and have moderate to high dietary glycemic index
15880419|NCT03801824|Other|Low Glycemic Index|Subjects will be advised to eat low glycemic index foods
15880420|NCT03801811|Procedure|Study of the efficacy of using skin glue in the application of Port a cath|The use of glue as a device in the implantation of central venous catheters has recently been introduced into European clinical practice. It is possible that the surgical incision created for the insertion of the PORT may be subject to complications such as: local bleeding, which if not properly treated may last even a few days, infections or surgical wound outbreaks. This possibility of bleeding occurs more easily in patients suffering from coagulation problems or when appropriate preventive measures have not been taken at the time of implantation of the device. A solution to this problem could be the application of the cyanoacrylate dermal glue on the edges of the surgical wound, after intradermal suture. The glue would have the purpose of sealing the surgical wound so as to immediately seal the skin incision with hemostatic effect and create a potential barrier against bacterial infections.
15880421|NCT03801798|Drug|GC1102|NAs antivirals+GC1102 180,000 IU
15880422|NCT03801798|Other|GC1102 Placebo|NAs antivirals+GC1102 Placebo
15880423|NCT03801785|Other|Pacifier|The pacifiers used in this clinical trial have the same shape and material. They are produced by Artsana S.P.A. for soothing children. As such, the FDA has no jurisdictions over pacifiers (US FDA regulations May 15, 2012 https://www.fdaimports.com/blog/pacifiers-fda-change-abi-system/) because they are not medical devices intended for teething.
15880474|NCT03801421|Procedure|Interrupted suture with thread|The surgical incision will be treated by interrupted suture with thread.
15880475|NCT03801395|Other|There is no intervention|No intervention
15880476|NCT03801382|Device|IntelliSpace Cognition (ISC)|Philips ISC is a Class-II Medical Device in the US and provides objective data regarding cognition via scoring algorithms that HCPs can use to inform diagnostic decision making and treatment planning. It enables tracking cognition over time and offers the possibility of new outcome measures. ISC can be used in a variety of healthcare environments such as neurology and neuropsychology practices.
15880424|NCT03801772|Device|Metronome|Pacing aquatic exercises to the beats per minute of a metronome. The metronome will be adjusted to each patient's pain free exertion level. Patients will start with 10-20 repetitions of the exercises depending on their physical ability. The repetitions will be progressed as the patient's strength and endurance improve and noted in the chart and the flow sheet. The metronome will be synchronized during their second aquatic therapy treatment. The beats per minute (BPM) will be increased on the metronome during the series of treatments until the patient can no longer maintain proper technique with the exercises. The exercises will continue at this BPM during future visits. The patient will be instructed to keep pace with the beat of the metronome for the duration of the exercise.
15880425|NCT03801759|Drug|Vadadustat|Oral dose 600 mg
15880426|NCT03801759|Drug|Furosemide|Oral Furosemide
15880427|NCT03801759|Drug|Adefovir|Oral Adefovir
15880428|NCT03801759|Drug|Digoxin|Oral Digoxin
15880429|NCT03801746|Drug|vadadustat|Oral dose 300 mg
15880430|NCT03801746|Drug|Rifampin|IV Rifampin
15880431|NCT03801746|Drug|Probenecid|Oral Probenecid
15880432|NCT03801746|Drug|Cyclosporins|Oral Cyclosporine
15880433|NCT03801733|Drug|Vadadustat|Oral dose of 600 mg QD
15880434|NCT03801733|Drug|Simvastatin|Oral Simvastatin
15880435|NCT03801733|Drug|Rosuvastatin|Oral Rosuvastatin
15880436|NCT03801733|Drug|Atorvastatin|Oral Atorvastatin
15880437|NCT03801733|Drug|Pravastatin|Oral Pravastatin
15880438|NCT03801733|Drug|Sulfasalazine|Oral Sulfasalazine
15880439|NCT03801720|Other|Ultrasound|Using ultrasound stimulation to induce micturition.
15880440|NCT03801707|Drug|Sofosbuvir / Velpatasvir Oral Tablet [Epclusa]|fixed dose combination medication once a day for 12 weeks for the treatment of hepatitis C
15880441|NCT03801707|Drug|Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet [MAVYRET]|Three tablets once a day for 12 weeks for treatment of hepatitis C
15880442|NCT03801681|Diagnostic Test|ECG holter monitoring|patients will be monitored using ECG-holter
15880443|NCT03801668|Drug|Albumin-bound Paclitaxel plus S-1|Albumin-bound Paclitaxel 260mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days.
15880444|NCT03801668|Drug|Oxaliplatin plus S-1|Oxaliplatin 130mg/m2 IV on D1 plus S-1 80mg/m2 PO (Bid) on D1-14 every 21 days.
15880445|NCT03801655|Dietary Supplement|Bio-Kult|4 capsules/day
15880446|NCT03801655|Other|Placebo|4 capsules/day
15880447|NCT03801642|Drug|Dapagliflozin|10 mg oral tablets taken once daily for 12 weeks
15880448|NCT03801642|Other|Placebo|Placebo tablet (matched in size and color to active tablet) taken once daily for 12 weeks
15880449|NCT03801629|Drug|High Morphine Dose|Subjects will receive an intramuscular morphine injection (0.07mg/kg) in the non-dominant deltoid muscle. Metoclopramide (10mg; oral) will be administered PRN to reduce nausea.
15880450|NCT03801629|Drug|Low Morphine Dose|Subjects will receive an intramuscular morphine injection (0.04mg/kg) in the non-dominant deltoid muscle. Metoclopramide (10mg; oral) will be administered PRN to reduce nausea.
15880451|NCT03801616|Device|Virtual Reality|Virtual Reality in controlling pain
15880452|NCT03801603|Behavioral|HPV vaccination training and education|1) Training of providers and clinic staff on the importance of providing a strong HPV vaccination program and 2) HPV vaccination education for parents and the community.
15880453|NCT03801590|Device|Crosslinking with Riboflavin and UV-A|the procedure of cross linking(CXL) :combined riboflavin-ultraviolet type A rays (UVA) collagen cross-linking. Radiant energy was 3 milliwatts/cm2 for a 30-minute exposure irradiation of the cornea.
15880454|NCT03801577|Dietary Supplement|Hepaxa|High concentrate EPA and DHA
15880455|NCT03801564|Device|Platelet Rich Plasma Treatment Group (PRP)|EASY PRP is in category IIa and manufactured by Neotec Biotechnology Industry and Foreign Trade Company. (Item No. 8680976403603; UNSPSC 42295470; GMDN 46923; certificate no: M.2016.106.7294).
15880456|NCT03801564|Device|Hyaluronic Acid Treatment Group (HA)|REGENFLEX STARTER is a class III intraarticular viscosupplementation device (Art. No. 8681065100076; UNSPSC 42295509). Sodium hyaluronate is obtained by bacterial fermentation (STREPTOCOCCUS EQUI) method. The product is in disposable packages, sterile and contained in a 2 ml pyrogen-free syringe.
15880457|NCT03801551|Diagnostic Test|Validate according to psychometric criteria, a dimensional measure of apathy in a population suffering from schizophrenia spectrum disorder and other psychotic disorders (according to DSM-5 criteria).|Validate according to psychometric criteria, a dimensional measure of apathy in a population suffering from schizophrenia spectrum disorder and other psychotic disorders (according to DSM-5 criteria).
15880458|NCT03801538|Drug|Peginterferon Alfa|Peginterferon Alfa-2A 180 micrograms/week or Peginterferon Alfa-2B 180 micrograms/week, for at most 96 weeks.
15880459|NCT03801538|Drug|Nucleoside Analog (Substance)|Patients do not need to change their NAs treatment.
15880460|NCT03801525|Drug|Ublituximab|"recombinant chimeric anti-CD20 monoclonal antibody
~administered as an IV infusion"
15880461|NCT03801525|Drug|Umbralisib|"PI3K delta inhibitor
~Tablet form"
15880462|NCT03801525|Drug|Venetoclax|"BCL-2 inhibitor
~Tablet form, to be taken orally"
15880463|NCT03801512|Other|Steroid|Triamcinolone 1pc + lidocaine 1% 1cc inject at neuritis nerve roots
15880464|NCT03801512|Other|Acupuncture|1.5 inch acupuncture needles insert at acupoints BL23, BL24, BL25 and BL26
15880465|NCT03801512|Other|Platelet Rich Plasma|Inject investigators Platelet Rich Plasma at neuritis nerve roots
15880466|NCT03801499|Drug|Lenvatinib|12 mg (or 8 mg) once daily (QD) oral dosing.
15880467|NCT03801486|Other|Experimental: Sprouted Chickpea Flour|255g of pasta with 40% sprouted chickpea flour and 60% semolina flour (SCF40) with butter.
15880468|NCT03801486|Other|Control: Semolina Flour|255g of pasta with 100% semolina flour (SEM100) with butter.
15880469|NCT03801473|Other|robot assisted gait therapy|The Robogait is a fixed lower body hip-knee exoskeleton. The user's weight is supported by a combination of an overhead attached harness and the support from the exoskeleton.
15880470|NCT03801473|Other|Conventional rehabilitation|Conventional rehabilitation program. Exercise and walking education is performed by the physiotherapists.
15880471|NCT03801460|Other|Remotely administered physiological reconditioning program|Patients assigned to intervention arm will be provided a personalized, tailored and graduated exercise program to improve physical strength and conditioning.
15880472|NCT03801434|Drug|Ruxolitinib|Given PO
15880477|NCT03801382|Diagnostic Test|Paper-Pencil Tests|The same cognitive tests that are on the ISC platform are performed using paper and pencil (rather than digitally) as is the case in standard clinical practice.
15880478|NCT03801369|Biological|Durvalumab|Given IV (infusion)
15880479|NCT03801369|Drug|Olaparib|Given PO (orally)
15880480|NCT03801356|Drug|Selective Nerve Root Block|Prior to single level foraminotomy for lumbar foraminal stenosis, patients will undergo SNRB of the suspected nerve root. Patients will undergo surgery despite the response to injection. Patients will complete an ambulation assessment immediately before and after the injection. Distance and time will be noted. Patients will be called within 48 hours of injection to determine response to injection, and recorded as Pre-and Post-injection VAS leg as well as duration of the response. Patients will be seen at 6 weeks, 3,6, and 12 months post-surgery and outcome measured by VAS-leg, ODI, PDQ and EQ-5D scores. Data will be used to determine the ideal improvement in leg pain and duration of improvement, predicting a statistical and meaningful improvement in leg pain following foramintomy.
15880481|NCT03801343|Dietary Supplement|Nutrakos®|"Nutrakos® Amino Acid Food Supplement supplies a specific mixture of amino acids that has been proven to induce synthesis of collagen and elastin, the main proteins of derma structure in fibroblasts and keratocytes."
15880482|NCT03801330|Other|Usual Care Pulmonary Rehabilitation Program|Participants in the Usual Care Pulmonary Rehabilitation Program group will complete an 8 week clinic based Pulmonary Rehabilitation Program (usual care).
15880483|NCT03801330|Other|Pulmonary Rehabilitation Software-Based Home Program|Participants in the Pulmonary Rehabilitation Software-Based Home Program group will complete an 8-week home-based Pulmonary Rehabilitation Program using a software app (software)
15880484|NCT03801317|Dietary Supplement|BC/ egg|4.3 egg powder + 5.7 g bovine colostrum
15880485|NCT03801317|Dietary Supplement|Control|15 grams corn-soya blend
15880486|NCT03801317|Dietary Supplement|multiple micronutrient|multiple micronutrient sprinkle powder
15880487|NCT03801304|Drug|Atezolizumab|Atezolizumab in IV infusions
15880488|NCT03801304|Drug|Vinorelbine|Vinorelbine capsules
15880489|NCT03801291|Procedure|Transvaginal repair|Vaginal incision through which plication of the rectovaginal septum is done
15880490|NCT03801291|Procedure|Transperineal repair|Perineal incision through which plication of the rectovaginal septum is done
15880491|NCT03801278|Drug|FPA144|Bemarituzumab administration every two weeks
15880492|NCT03801265|Procedure|Lumbar plexus block|Patient will be positioned in lateral decubitus position with side to be blocked facing upwards. Midline will be identified by palpating the spinous process. Intercristal line will be drawn connecting iliac crests. The point of needle insertion will be 4 cm lateral to the intersection of both lines. The transverse process will first contact with a finder needle. Subsequently an 18 gauge 10 cm insulated needle will be used and advanced until it contacted the transverse process. Needle will then be redirected cephalad or caudad and advanced 2 cm, until the quadriceps femoris twitch is obtained. Local anesthetic will then be injected after confirming a motor response between 0.3-0.5 milli amperes.
15880493|NCT03801265|Procedure|Quadratus lumborum type 3 block|Patient will be placed in a lateral position with the side to be blocked facing up. A low frequency transducer will be used to identify three layers of abdominal musculature, probe will be then moved posteriorly till the transverse abdominus aponeurosis is visualized, the QL muscle is then identified by tracing the aponeurosis posteriorly. The transducer is then moved more posteriorly to visualize the shadow of transverse process and the origin of QL muscle. Psoas muscle is then identified lying anterior to the QL muscle. A 22 gauge 8 cm is inserted in plane posterior to the probe and advanced intramuscularly through the QL to interfacial plane between QL and psoas major and local anesthetic is deposited.
15880494|NCT03801265|Drug|Ropivacaine injection|0.5% ropivacaine 20 ml (100 mg) will be injected for both groups.
15880495|NCT03801252|Drug|Cefazolin|intravenous drugs used as prophylactic antibiotics
15880496|NCT03801252|Drug|Placebo|Intravenous saline
15880497|NCT03801252|Drug|Azithromycin|prophylactic antibiotic
15880498|NCT03801239|Diagnostic Test|Urodynamic Study|during visit Week 0 patients had urodynamic study
15880499|NCT03801239|Diagnostic Test|OABSS questionnaire fulfilment|during visit Week 0 and Week 2 patients fulfilled OABSS
15880500|NCT03801239|Diagnostic Test|UDI-6 questionnaire fulfilment|during visit Week 2 patients fulfilled UDI-6 questionnaire
15880501|NCT03801239|Diagnostic Test|IIQ-7 questionnaire fulfilment|during visit Week 2 patients fulfilled IIQ-7 questionnaire
15880502|NCT03801226|Drug|Two-hour dwell with 10% dextrose in sterile water|Patients will be randomized to undergo a two-hour dwell with 10% dextrose in sterile water at their first or second study visit and will receive the alternate intervention at the other study visit.
15880503|NCT03801226|Drug|Two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose|Patients will be randomized to undergo a two-hour dwell with Dianeal Low-Calcium with 4.25% Dextrose at their first or second study visit and will receive the alternate intervention at the other study visit.
15880504|NCT03801213|Device|urinary catheterization|Urinary catheterization with pain controlled
15880505|NCT03801213|Procedure|manual bladder stimulation technique|manual gentle tapping in the suprapubic area at a frequency of 100 taps per minute for 30 seconds followed by lumbar paravertebral massage maneuvers for 30 seconds. The renal and bladder stimulation will be performed in less than 3 minutes, with a maximum of two attempts spaced about 20 minutes
15880506|NCT03801200|Drug|Apatinib|radiotherapy with Apatinib
15880507|NCT03801187|Procedure|chlorhexidine|Inflammatory tissue, excess cement or plaque deposits will be removed using titanium curettes and the implant surface will be cleaned by copious irrigation with sterile saline and surgical gauze soaked in chlorhexidine.
15880508|NCT03801187|Procedure|Er:YAG laser|Er.YAg laser treatment will be provided on the implant surface.
15880509|NCT03801187|Procedure|Air-Powder|An air powder device will be treatment will be provided on the implant surface.
15880510|NCT03801174|Behavioral|Partner-assisted intervention|All patients will receive group-based weight loss program for 6 months featuring a calorie-restricted diet and physical activity. Then, all patients will receive a weight loss maintenance intervention for 12 months that involves maintenance-specific content, transitions to individual telephone calls, and decreases frequency of contact. Partners will attend some patient group sessions and be informed of patients' goals and relapse plans. Intervention will be withdrawn for the last 6 months to examine sustainability of effects.
15880511|NCT03801174|Behavioral|Patient-only intervention|All patients will receive group-based weight loss program for 6 months featuring a calorie-restricted diet and physical activity. Then, all patients will receive a weight loss maintenance intervention for 12 months that involves maintenance-specific content, transitions to individual telephone calls, and decreases frequency of contact. Intervention will be withdrawn for the last 6 months to examine sustainability of effects.
15880512|NCT03801161|Biological|Pentavalent vaccine. It is a combination of five different antigens (Hepatitis B (HBV)/ Haemophilus influenzae type b (HiB) / Tetanus-Diphtheria-whole cell Pertussis (TDwP)).|Pentavalent vaccine is being recommended to provide infants at 6wk, 10wk and 14wk of age. This vaccine also induces plasma CRP >5 mg/L in infants within 24 hours of immunization.
15880513|NCT03801148|Drug|30 mg dexlansoprazole capsules manufactured at TOB|Dexlansoprazole delayed-release capsules.
15880514|NCT03801148|Drug|30 mg dexlansoprazole capsules manufactured at TPC|Dexlansoprazole delayed-release capsules.
15880515|NCT03801148|Drug|60 mg dexlansoprazole capsules manufactured at TOB|Dexlansoprazole delayed-release capsules.
15880516|NCT03801148|Drug|60 mg dexlansoprazole capsules manufactured at TPC|Dexlansoprazole delayed-release capsules.
15880517|NCT03801135|Drug|Fibrinogen concentrate|Haemocomplettan will be infused after plasma exchange procedure
15880518|NCT03801135|Other|Fresh Frozen Plasma|Fresh frozen plasma will be part of replacement fluid
15880519|NCT03801122|Drug|Tranexamic acid|Administration of tranexamic acid, with 3 injections/8 hours.
15880520|NCT03801109|Other|Hyperbaric group|Participants in this group performed 5 sessions per week for 8 weeks (40 sessions in total) . The time of each session is 90 minutes and the chamber pressure is 1.4 ATA with a 100% oxygen mask.
15880521|NCT03801109|Other|Magnetic group|There will be 5 sessions per week for 2 consecutive weeks (10 sessions in total), stimulating the left motor cortex at high frequencies, 10 Hz, for 30 minutes.
15880522|NCT03801109|Other|Physical group|A protocol of low-impact physical exercise will be performed twice a week for 8 weeks, with a total of 16 sessions.
15880523|NCT03801109|Other|Baseline group|This group will be the control group that did not take any action, perform the activities of daily life
15880524|NCT03801096|Behavioral|Narrative Based Therapuetic Assessment (NbTa)|The NbTa interventiom will guide participants through an exploration of their human experience through stories and narratives. The interventionist will facilitate a collaborative process by which participants will explore the unique themes and meanings of their personal narrative (Parry & Doan, 1994) with respect to alcohol and drug use. In addition, participants will also be guided towards considering the re-authorship of personal narratives. The techniques utilized in NbTa aim to dislodge problem saturated narratives and derive more complete personal narratives and meanings (White & Epston, 1990).
15880525|NCT03801096|Behavioral|Health Education Control Condition (HE)|The Health Education session is a didactic 45-minute session that focusses on three health-related topics: 1) Sleep, 2) Physical Activity, and 3) Nutrition. The goal of the session is to present health-related information to participants through videos and dydadic presentation.
15880526|NCT03801083|Biological|Tumor Infiltrating Lymphocytes (TIL)|TIL are to be infused intravenously through a central vein catheter over 20-30 minutes followed by Aldesleukin, administered at a dose of 600,000 IU/kg (based on total body weight) as an intravenous bolus over a 15-minute period approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to a maximum of 6 doses.
15880527|NCT03801070|Procedure|endoscopic drainage of walled off pancreatic necrosis|transmural drainage and mechanical debridement of solid debris (necrosectomy)
15880528|NCT03801057|Dietary Supplement|MPH_active|One daily intake at breakfast of supplementary marine protein hydrolysate (MPH), a dosage of 2400 mg, duration 6 weeks. The form is powder, flavored with lemon, and to be mixed with 100 ml water. Random sequence of arms.
15880529|NCT03801057|Dietary Supplement|MPH_placebo|One daily intake at breakfast of supplementary placebo, a dosage of 2400 mg, duration 6 weeks. The form is powder, flavored with lemon, and to be mixed with 100 ml water.
15880530|NCT03801044|Diagnostic Test|NT-BNP, VEGF|VEGF-C levels were measured in the serum samples. R&D Systems kit (Minneapolis, MN) (Catalog Number DVEC00) was used for the assays according to the user instructions. NT-proBNP was measured on the Elecsys 2010 analyzer (Elecsys proBNP Immunoassay; Roche Diagnostics).
15880531|NCT03801044|Diagnostic Test|Echocardiography|Transthoracic echocardiography was performed by the same cardiologist blinded to all other parameters. It was done while abdomen was empty. LV end diastolic diameter (mm), interventricular septum thickness (mm), posterior wall thickness (mm), ejection fraction (%), left ventricle end diastolic volume (ml), left atrial volume (ml), left ventricle mass index (LVMI) (g/m2), left ventricle filling velocity(cm/sec), E/E' ratio, pulmonary artery systolic pressure (mm Hg) were the parameters taken by echocardiography
15880532|NCT03801044|Radiation|Chest Radiography|All radiographies were taken when the patient was standing erect position during deep inhalation. They were reported by an expert radiologist blinded to clinical data. Films taken at supine position or during exhalation were excluded. Chest radiographies were classified into 3 stages to reflect degree of hypervolemia. Stage 1 was redistribution defined as increased artery-to-bronchus ratio in the upper and middle lobes. Stage 2 was interstitial edema evident by Kerley B lines and peribronchial cuffing. Stage 3 was alveolar edema phase perihilar consolidation and air bronchograms, pleural fluid, increased width of the vascular pedicle, enlarged cardiac silhouette.
15880533|NCT03801044|Diagnostic Test|Lung Ultrasound|It was performed by 28 area method which contains ultrasound examination from second to fifth intercostals spaces at parasternal region, midclavicular line, anterior and mid axillary lines. Lung ultrasound had been done by same radiologist who was an expertise in ultrasonography blinded to all other parameters. It was performed by 1,6 megaHertz convex probe when patient lying at the supine position.
15880534|NCT03801044|Diagnostic Test|Bioelectrical Impedence Analysis|The Body Composition Monitor (BCM) (type 0BJA1394, Fresenius Medical Care AG & Co. KGaA, D-61343 Bad Homburg) was used for assessment of hydration status in patients. Peritoneal cavities were free of intraperitoneal fluid during measurement. Patients were accepted as normovolemic if their result were between -1.1lt and 1.1 lt.
15880535|NCT03801031|Drug|Lidocaine Topical|Many women treated for gynecologic cancer complain of sexual dysfunction and discomfort. It is thought that topical lidocaine application prior to sexual encounters may have reduced discomfort and improved overall quality of life during and following cancer treatment. The use of the lidocaine solution/placebo is the intervention.
15880536|NCT03801031|Drug|Placebo|Placebo solution intervention used to validate the effects of the lidocaine solution usage.
15880537|NCT03801018|Other|Questionnary and Interviews|"An internet platform dedicated to the anonymous survey will be set up by the communication department and the digital System Department of the promoter Public assistance hospitals in Marseille, the data Processing manager. It would deplore anonymous questionnaires accessible from a dedicated web page. People will therefore respond to a national survey on the basis of volunteering and anonymity.
~Interviews, lasting one to two hours, will be fully transcribed and processed anonymously.
~The interviews will seek to collect data on the modalities, conditions and effects of the circulation (or retention) of information on the use of donation, throughout the lives of individuals and families, in a cross-analysis of Viewpoints of parents and people born of donation."
15880538|NCT03801005|Biological|Blood and Marrow sample|"Twenty patients will be included in a prospective way over a period of nine months. No additional medullary or serum samples will be carried out in addition to those required for the clinical routine. Only an additional blood sample taken during a routine blood test will be recovered as part of the research. Just as some leftover bone marrow, taken as part of a usual unused follow-up will be recovered as part of this trial.
~The persons concerned will be recruited on the occasion of their hospitalisation in one of the hematology services participating in the research, or during their consultation with one of the hematologists of the corresponding service (or services). On this occasion, detailed information on their pathology and research will be given, as well as the information document on the proposed research protocol."
15880539|NCT03800992|Other|assessment of perception and evaluation of physicians advisory skills per questionnaire|questionnaire according to SPIKES - a Six-Step Protocol for Delivering Bad News to be completed by parents and children (older than eleven)
15880540|NCT03800979|Drug|Tofacitinib|Tofacitinib is an oral medicine in Janus kinase inhibitor 3 group which has been approved by FDA in treating Rheumatoid Arthritis. It has ability to inhibit nerve signal Interferon-ɣ and Interleukin-15 between white blood cell(WBC) and the nucleus of hair follicle cell causing the production of WBC type CD8+NKG2D+ T cell to slow down which this type of WBC is one of the cause of hair loss.
15880541|NCT03800966|Other|Leaflet|Leaflets for both groups will be printed in colour. Leaflet in each group contains 8 pictures and 8 statement, whose sequences will be scrambled. Primary school students need to do the matching, to ensure they read the statements.
15880542|NCT03800953|Drug|Avelumab|The study treatment comprises two phases, the concurrent immune-chemoradiotherapy (Ave-PF-CRT) phase and the immune-chemotherapy (Ave-PF) phase. All the subjects will receive Avelumab at both phases.
15880543|NCT03800940|Procedure|Fistulography and trans-drain occlusion|"Fistulography: an 18G needle is inserted into the tube and diluted contrast medium is slowly injected into the tube.
~Trans-drain occlusion: a 0.035-inch guidewire is inserted via the puncture needle. The drain tube is removed, cut at 4 cm proximal to the skin fixation site, and preserved for reinsertion. After inserting a 40cm 5Fr KMP catheter over the guidewire, the guidewire is removed. Afte rinsing the KMP catheter with 3ml 5% glucose water, withdraw the catheter and simultaneously inject glue (33%, 1:2, 0.5ml of NBCA + 1ml Lipiodol) into the catheter until the proximal 5cm of the catheter remains inside the tract. The guidewire is re-inserted through the catheter, and then the original drain tube is re-inserted over the guidewire. The guidewire is removed and the drain is fixed."
15880544|NCT03800940|Procedure|Fistulography|Fistulography: an 18G needle is inserted into the tube and diluted contrast medium is slowly injected into the tube.
15880545|NCT03800927|Device|Long duration ultrasound|Low-intensity long duration ultrasound treatment
15880546|NCT03800914|Other|High intensity interval training|36 minutes of interval exercise on cycle ergometer alternating every 30 seconds between 100% peak work rate achieved on cardiopulmonary exercise test and unloaded cycling
15880547|NCT03800914|Other|Traditional pulmonary rehabilitation|30 minutes of continuous exercise on cycle ergometer at 60% peak work rate achieved on cardiopulmonary exercise test.
15880548|NCT03800901|Other|Continuing Medical Education|CME or ABIM MOC credits
15880549|NCT03800901|Other|Quality IQ Patient Simulations|"Online patient cases designed to simulate typical patients seen in a primary care practice. In each case, providers will answer multiple-choice questions about their preferred course of action to work-up, diagnose and treat patients in the primary care setting. After each question, providers will receive evidence-based feedback, including references, on the appropriateness of each of their care decisions. Feedback will be supported with relevant reference to evidence-based guidelines, including national MIPS quality measures.
~Cases will cover clinical conditions aligned with MIPS measures that are commonly seen in the primary care setting including: diabetes, hypertension, depression, osteoarthritis, asthma and pain control."
15880550|NCT03800888|Other|Daily SMS reminders for TB patients|Daily SMS Medication reminders will be sent to TB patients to remind them take their medications.
15880551|NCT03800888|Other|SMS Notifications for social supporters|SMS Notifications will be sent to social supporters to assit TB patients take their medication
15880552|NCT03800888|Other|Weekly SMS remiders|Weekly SMS reminders sent to TB patients to remind them take medication
15880553|NCT03800875|Drug|27-hour inpatient intervention|Subjects will be admitted at the research facility at 19:00. Each 27-hour intervention visit includes 3 standardized meals (8:00, 12:00, and 17:00), an evening snack (22:00) and an overnight stay. The glucose level as measured by the real time sensor will be entered manually into the computer every 10 minutes. The infusion rate of either insulin alone or insulin and pramlintide will be changed manually based on the computer generated recommendation. The computer generated recommendations are based on a predictive algorithm.
15880554|NCT03800862|Device|CT-FFR and CTP|Those who agree to participate will be scheduled to have the CT-FFR and CTP performed within sixty days of the initial Coronary CTA procedure. A CTA will be performed at rest for FFR. The patient will then take approximately a 30 min break. Regadenoson will then be administered and the dynamic CT procedure will be done for perfusion.
15880555|NCT03800836|Drug|Ipatasertib|Ipatasertib will be administered at a dose of 400 milligrams (mg) orally daily on Days 1-21 of each 28 day cycle for all arms except for arms F1/F2 where it will be administered at a dose of 300 milligrams (mg) orally daily for the first two cycles and 400 mg for the remaining three cycles.
15880556|NCT03800836|Drug|Paclitaxel|Paclitaxel will be administered at a dose of 80 milligrams per square meter (mg/m^2) as IV infusion on Days 1, 8, and 15 of each 28 day cycle for all arms, with the exceptions of Arms F1, F2, G1 and G2, where it will be also administered on Day 22 as well, of each 28 day cycle.
15880557|NCT03800836|Drug|Atezolizumab|Atezolizumab will be administered by IV infusion at a fixed dose of 840 mg on Days 1 and 15 of each 28 day cycle for all arms, although in Arms C1/C2, it will be administered on Day 15 of Cycle 1 followed by Days 1 and 15 in subsequent cycles.
15880558|NCT03800836|Drug|Nab-Paclitaxel|Nab-paclitaxel will be administered by IV infusion at a dose of 100 mg/m^2 on Days 1, 8, and 15 of each 28 day cycle.
15880559|NCT03800836|Drug|AC|AC (Doxorubicin and Cyclophosphamide) will be administered by IV infusion at 60 mg/m^2 and 600 mg/m^2 respectively on Days 1 and 15 of Cycles 1 and 2 for Arms F1, F2, G1 and G2.
15880560|NCT03800823|Behavioral|Parent group|In group sessions parents will learn how to use positive parenting practices (e.g., encouragement and limit setting) instead of ineffective practices (e.g., coercive behaviour, negative reciprocity). Using a parent group approach, each of the 10 sessions consist of introduction to effective parenting practices followed by a discussion and practice using role play and home practice assignments.
15880561|NCT03800823|Behavioral|mHealth component|After the group sessions, parents will receive a 6-month mHealth program (MINISTOP app) based on social cognitive theory with strategies to change unhealthy diet/physical activity behaviours. The program includes information, advice, and strategies to change unhealthy behaviours and the possibility to register the child's intake of fruit, vegetables, candy, sweetened beverages, and sedentary time.
15880562|NCT03800823|Behavioral|Standard care|Standard care for overweight and obesity.
15880563|NCT03800810|Drug|Hyaluronic Acid|
15880564|NCT03800810|Biological|Umbilical Cord Mesenchymal Stem Cell|
15880565|NCT03800810|Biological|Recombinant Human Somatropin|
15880566|NCT03800797|Drug|Loxoprofen sodium hydrogel patch|100 mg per day
15880567|NCT03800797|Drug|Loxoprofen sodium tablet|60 mg t.i.d.
15880568|NCT03800784|Drug|18F-DCFPyL Injection|A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL
15880569|NCT03800771|Device|Cycléo BRAU|Practice dual-task tests.
15880570|NCT03800771|Device|GAITRITE®|Routine practice dual-task tests.
15880571|NCT03800758|Behavioral|Expressive Helping|Expressive Helping (EH) is completed in 4 brief structured writing sessions during and immediately after transplant, with instructions focused on having participants write about their transplant experience using previously-tested EH instructions, adapted for this population.
15880572|NCT03800758|Behavioral|Factual Writing|Factual Writing has been used with cancer patients and in the investigators' prior EH trial. It is completed in 4 brief structured writing sessions during and immediately after transplant, with instructions focused on having participants write about their transplant experience using standard Factual Writing instructions.
15880573|NCT03800745|Drug|Colace 100Mg Capsule|Prescribed to Arm B
15880574|NCT03800745|Drug|Miralax|Prescribed to Arm C
15880575|NCT03800732|Other|With Meal during night work|Two nights of work with a meal during the shift and after will go to the laboratory the morning for eating a test meal ad libitum, which will consist of foods of various compositions and food groups. Preprandial metabolic assessments will be conducted (ghrelin, GLP-1 - glucagon-like peptide 1, PYY-peptide YY). The following postprandial evaluations will be carried out and in the 24 hours following the experiment: food choices (record of all foods) and food perceptions (hunger, appetite, satiety and eating).
15880576|NCT03800732|Other|Without Meal during night work|Two nights of work without a meal during the shift and after will go to the laboratory the morning for eating a test meal ad libitum, which will consist of foods of various compositions and food groups. Preprandial metabolic assessments will be conducted (ghrelin, GLP-1 - glucagon-like peptide 1, PYY-peptide YY). The following postprandial evaluations will be carried out and in the 24 hours following the experiment: food choices (record of all foods) and food perceptions (hunger, appetite, satiety and eating).
15880577|NCT03800732|Other|Sleep night|Two sleep nights and after will go to the laboratory the morning for eating a test meal ad libitum, which will consist of foods of various compositions and food groups. Preprandial metabolic assessments will be conducted (ghrelin, GLP-1 - glucagon-like peptide 1, PYY-peptide YY). The following postprandial evaluations will be carried out and in the 24 hours following the experiment: food choices (record of all foods) and food perceptions (hunger, appetite, satiety and eating).
15880578|NCT03800719|Behavioral|AWARD advice|"At baseline, brief smoking cessation advice following AWARD model will be delivered to subjects within about 2 to 5 minutes:
~Ask about smoking history and habit
~Warn about the risks of smoking using a leaflet
~Advise to quit smoking as soon as possible and use nicotine replacement therapy (NRT) or SC services
~Refer subjects to free smoking cessation services in Hong Kong if they agree
~Do it again: smokers who have tried to quit but relapsed will be encouraged to quit again and those who have reduced smoking will be advised to further reduce or quit smoking"
15880579|NCT03800719|Behavioral|Health warning leaflet|At baseline, an A5-sized leaflet will be given to subjects, which includes information about risks of smoking, pictures of smoking-related diseases, and smoking cessation services provided in Hong Kong.
15880580|NCT03800719|Behavioral|Active referral to smoking cessation (SC) services|At baseline, subjects will be encouraged to seek smoking cessation services in Hong Kong. If subjects agree, their contact information will be sent to the preferred service providers for a quick appointment and follow-up.
15880581|NCT03800719|Behavioral|Regular messages through Instant Messaging (IM)|A total of pre-set 26 messages will be sent to subjects through WhatsApp 12 weeks after baseline to remind the quit date and to encourage abstinence. Messages are tailored based on subjects' sociodemographic characteristics and smoking habit following Social Cognitive Theory and Transtheoretical Model. Messages will be sent with the schedule of once daily for 1 week (the week across the quit date), 3 times a week for 4 weeks (2 weeks each before and after the week with quit date) and once a week for remaining 7 weeks. The schedule will be adjusted according to the quit date and also smokers' requests. The format of regular messages will mainly be text-based but also include pictures, animations and videos.
15880582|NCT03800719|Behavioral|Psychosocial support and referral to SC services through IM|Personalized interactive text or voice conversation will be provided by trained smoking cessation advisors through WhatsApp for 3 months after baseline. Advisors will periodically proactively send messages to subjects to initiate the conversation (e.g. asking recent progress of smoking cessation) and deliver evidence-based advice. Advisors will also actively refer subjects, if they have expressed the need, to smoking cessation services providers. A standard operation algorithm for advisors used in the pilot feasibility trial will be modified for the use.
15880805|NCT03798925|Other|None Intervention|It is observational study
15880583|NCT03800719|Behavioral|Message on general health delivered by short message service (SMS)|After baseline, regular messages using SMS will be sent to subjects with similar frequency to Intervention group. The messages include information on general health and reminders on follow-up surveys and biochemical validation for quitting.
15880584|NCT03800706|Drug|TQB2450|TQB2450 is injectived (IV) every-3-weeks (Q3W) and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent, the longest use time of experimental drugs is 96 weeks.
15880585|NCT03800693|Drug|Fluorouracil|Given IV
15880586|NCT03800693|Drug|Leucovorin|Given IV
15880587|NCT03800693|Drug|Oxaliplatin|Given IV
15880588|NCT03800680|Behavioral|Diabetes Management Package (DMP)|"M-POWER app: A one-stop portal to monitor diabetes self-management activities and progress. The app syncs and displays relevant data from study devices and apps.
~GlycoLeap: A 24-week, digitally-delivered education and behavior change program for T2DM patients.
~4 study devices with accompanying apps to aid in diabetes self-management: weighing scale, pedometer, glucometer, and pill tracker.
~Recommended activities:
~Complete all 24 GlycoLeap lessons and quizzes
~Weight Monitoring: Weigh at least once a week.
~Physical Activity: At least 150 minutes of moderate-to-vigorous activity per week, targeting at least 420 Fitbit active minutes per week.
~Blood Glucose Monitoring: At least three post-meal measurements within 4.0-10.0 mmol/L per week, with each reading taken on different days.
~Medication: Take medications as prescribed."
15880589|NCT03800680|Behavioral|M-POWER Rewards|A financial incentive program were participants can earn up to 516 M-Points (1 M-Point is equivalent to S$1) over the one-year study period for performing specific activities according to recommendations that are meant to improve glycemic control and for achieving HbA1c and weight loss goals. M-Points can be reimbursed in the form of financial rebates for approved non-inpatient healthcare-related expenses incurred during the study period.
15880590|NCT03800667|Drug|Ascorbic Acid 1000 MG|1000 mg ascorbic acid (Vitamin C) for 1 month post-op after an elective gynecological surgery.
15880591|NCT03800654|Behavioral|Mindful Action for Pain|MAP integrates formal mindfulness meditation with methods from Acceptance and Commitment Therapy and Dialectical Behavior Therapy.
15880592|NCT03800654|Behavioral|Cognitive Behavioral Therapy for Chronic Pain|CBT-CP is the current gold standard psychosocial intervention for chronic pain and will be compared to MAP in the second arm of the study.
15880593|NCT03800641|Drug|Dexmedetomidine|oral, intravenous and nasal administration of Dexmedetomidine
15880594|NCT03800628|Other|qualitative study|semi-structured interviews
15880595|NCT03800615|Procedure|Cut the sling|Cut the mid-urethral sling for stress urinary incontinence
15880596|NCT03800602|Drug|Metformin|Given PO
15880597|NCT03800602|Biological|Nivolumab|Given IV
15880598|NCT03800589|Procedure|phacoemulsification with implantation of the Ex-Press|The conjunctiva is dissected with the base in the limbus. A square scleral flap is dissected with the based in the limbus. Phacoemulsification is performed through a corneal incision 2.75 mm from the temple using the phaco-chop technique. Mini seton was implanted at 12 o'clock according to the standard technique.
15880599|NCT03800589|Procedure|deep sclerectomy, phacoemulsification, ExPress implantation|The conjunctiva is dissected with the base in the limbus. Superficial flap is dissected with the based in the limbus. Phacoemulsification is performed through a corneal incision 2.75 mm from the temple using the phaco-chop technique. Deep scleral is dissected just below the trabeculo-Descemet membrane. The seton is implanted in the anterior chamber at the height of Schlemm's Canal.
15880600|NCT03800563|Device|LipoLife system|Abdominal/ Outer thighs Laser Assisted Liposuction. Five to twenty subjects out of the study group will also undergo facial fat grafting.
15880601|NCT03800550|Drug|Bedaquiline|Bedaquiline tablet will be administered, orally.
15880602|NCT03800550|Drug|Clarithromycin|Clarithromycin tablet will be administered, orally.
15880603|NCT03800537|Device|MR Fingerprinting|The MR fingerprinting technique requires less than 15 minutes and will be added following the standard MRI sequence.
15880604|NCT03800524|Drug|Tauroursodeoxycholic Acid|"Tauroursodeoxycholic acid (TUDCA) 250 mg capsules
~Doses: 4 capsules (1 g) twice daily 10-15 minutes after a meal
~Mode of administration: orally
~Duration: 18 months"
15880605|NCT03800524|Drug|Placebo|"Placebo 250 mg capsules
~Doses: 4 capsules (1 g) twice daily 10-15 minutes after a meal
~Mode of administration: orally
~Duration: 18 months"
15880606|NCT03800511|Diagnostic Test|sliding test|ultrasound detected sliding test before doing repeated caesarean section
15880607|NCT03800498|Other|DASH Education|DASH health education about general knowledge of DASH diet Plan and lifestyle modification
15880608|NCT03800485|Device|IMT|A training protocol of the inspiratory muscles that goes from the 15% of the maximal inspiratory muscle preassure until the 60% of the maximal inspiratory muscle preassure during 8 weeks
15880609|NCT03800472|Drug|GLPG3312 IR|GLPG3312 IR tablets, up to 4 single ascending oral doses (A, B, C, D).
15880610|NCT03800472|Drug|Placebo|Placebo tablets
15880611|NCT03800472|Drug|GLPG3312 MR|GLPG3312 MR film-coated tablets, up to 4 single ascending oral doses (H, I, J, K).
15880612|NCT03800472|Drug|GLPG3312 FE MR|GLPG3312 MR film-coated tablets, single oral dose (N) on 2 occasions, i.e. in fed state after a high-fat high-calorie breakfast, and in fasted state.
15880613|NCT03800472|Drug|GLPG3312 MR|GLPG3312 MR film-coated tablets, up to 2 multiple ascending oral doses (O, P).
15880614|NCT03800472|Drug|GLPG3312 MR|GLPG3312 MR optimized film-coated tablets, up to 3 multiple ascending oral doses (Q, R, S).
15880615|NCT03800472|Drug|Placebo|Placebo optimized tablets
15880616|NCT03800459|Behavioral|family empowerment program|The empowerment program-nursing interventions were given in 6 sessions in the experimental group Session 1: Individualized training: General information about CF, respiratory system involvement and treatment process, airway cleaning in CF, drug applications (45-50 min) Session 2:Phone calls: Motivational and reminder interviews were carried out in order to reinforce the content of the first individual training (15 min).Session 3:Phone calls:Motivational and reminder interviews were carried out in order to reinforce the content of the first individual training (15 min) Session 4:Individualized training:protection from infections, nutrition and psychosocial support (45 min) Session 5:Phone calls: Motivational and reminder interviews were carried out in order to reinforce the content of the second individual training. (10 min) Session 6:Phone calls: Motivational and reminder interviews were carried out in order to reinforce the content of the second individual training. (10 min)
15880617|NCT03800446|Diagnostic Test|Point of care ferritin test|Point of care test that uses capillary blood sample from finger to determine ferritin level
15880618|NCT03800433|Drug|Trental 400 MG Extended Release Oral Tablet|oral tablets
15880619|NCT03800420|Drug|BBT-401-1S|Total 16 week treatment period: BBT-401-1S, QD for the first 12 weeks and then placebo, QD for the last 4 weeks
15880620|NCT03800420|Drug|Placebo|Total 16 week treatment period: Placebo, QD for the first 8 weeks and then BBT-401-1S, QD for the last 8 weeks
15880621|NCT03800407|Other|Observational study|Outcome of EFV-based ART in children with TB/HIV coinfection compared to those with HIV only on EFV-based ART
15880622|NCT03800394|Other|Observational PK study|Effect of antituberculosis treatment, age and genetic factors on intracellular TFV-DP and FTC-TP concentrations
15880623|NCT03800381|Other|Observational PK study|The study team will examine the PK and tolerability of the new HRZ 50/75/150 mg dispersible tablet in children with TB with and without HIV coinfection. Intensive PK testing will be performed after at least 4 weeks of treatment in children on first-line anti-TB therapy using the new pediatric HRZ FDC tablet.
15880624|NCT03800368|Other|Exercise|Indoor cycling exercise intervention
15880625|NCT03800368|Other|Non-exercise|Psycho-education
15880626|NCT03800342|Other|Aerobic Exercise Training|see arm/group description
15880627|NCT03800329|Device|Snap40 Monitor|Non-invasive, wearable armband device used to measure change in systolic blood pressure, respiratory rate, heart rate, body temperature, movement, and oxyhemoglobin saturation and streams this information to a cloud-based storage system. Patients will complete a questionnaire.
15880628|NCT03800329|Other|No Monitor|Patients will be discharged in the ordinary manner, without the Snap40 monitor. Patients will complete a questionnaire.
15880629|NCT03800316|Device|Video Consultation|Video consultation with emergency medicine physicians for patients that are critically ill prior to arrival in the ED
15880630|NCT03800303|Behavioral|Family-based treatment|2-week family-based treatment
15880631|NCT03800290|Drug|Clenbuterol Hydrochloride|Daily ingestion of clenbuterol hydrochloride capsules (40 microgram/day) for a total period of 14 days with a wash-out period of 4 weeks.
15880632|NCT03800290|Drug|Placebos|Daily ingestion of placebo capsules for a total period of 14 days with a wash-out period of 4 weeks.
15880633|NCT03800277|Dietary Supplement|Cranberry|Supplementation of polyphenols from cranberry extract
15880634|NCT03800277|Dietary Supplement|Agaves|Supplementation of inulin from Agaves powder
15880635|NCT03800277|Dietary Supplement|Placebo|Supplementation with placebo
15880636|NCT03800264|Drug|Bisoprolol|PREVENTIVE DOUBLE BLINDED
15880637|NCT03800251|Dietary Supplement|Nutricia PreOp - a clear, non-carbonated, lemon flavoured, carbohydrate drink that provides 0.5kcal/ml|Fasting parturients at term, admitted for elective cesarean section and consent to partake in the study, will be given the intervention drink
15880638|NCT03800238|Behavioral|Telehealth Delivery Format|Participants will engage in a 6-week Powerful Tools for Caregivers program delivered via telehealth.
15880639|NCT03800238|Behavioral|Standard Delivery Format|Participants will engage in a 6-week Powerful Tools for Caregivers program delivered in the traditional in-person format.
15880640|NCT03800225|Procedure|Repair|Anterior ligament repair with internal brace.
15880641|NCT03800212|Drug|treatment for ampullary adenocarcinoma|all patients treated for ampullary adenocarcinoma (particularly survival without recurrence and prognostic indicators for excised tumours and the duration of disease control for tumours treated with palliative chemotherapy).
15880642|NCT03800199|Other|Perceptive rehabilitation|The first session will be an education session. Spinous processes will be reference line of the body and patient will lie down on cones. The therapist will ask the patient first to breathe normally and feel the pressure. This will lead the patient to relax and understand cones. Then, the patient will start with the diagrammatic breathing. After breath exercises patient will perform active exercises (include stretching, warming up and cooling down) on supervision. Exercises will include the whole body. Additional to this during the session therapist will ask about the pressure of cones and she will correct the patients' posture. At the end of all the session, the therapist will take a photo of the patients back with the aim of to document the pressure and hyperaemic areas.
15880643|NCT03800186|Other|Proximal type A|Patients with fracture of proximal type A
15880644|NCT03800186|Other|Proximal type B|Patients with fracture of proximal type B
15880645|NCT03800186|Other|Proximal type C|Patients with fracture of proximal type C
15880646|NCT03800186|Other|femoral shaft|Patients with fracture of femoral shaft
15880647|NCT03800186|Other|distal femur|Patients with fracture of distal femur
15880648|NCT03800173|Drug|galidesivir|galidesivir IV infusion
15880649|NCT03800173|Drug|placebo|placebo IV infusion
15880650|NCT03800147|Drug|"Mutaflor Suspension (E. coli Nissle 1917)"|"Inoculation of Mutaflor Suspension (E. coli Nissle 1917)"
15880651|NCT03800147|Other|Blood samples|Blood samples will be collected and analyzed at different study time points
15880652|NCT03800147|Other|Stool samples|Stool samples will be collected and analyzed at different study time points
15880653|NCT03800147|Other|Clinical information|Clinical information will be collected at different study time points using questionnaires
15880654|NCT03800134|Drug|Durvalumab|Durvalumab IV (intravenous infusion)
15880655|NCT03800134|Other|Placebo|Placebo IV (intravenous infusion)
15880656|NCT03800134|Drug|Carboplatin/Paclitaxel|Carboplatin/Paclitaxel, as per standard of care
15880657|NCT03800134|Drug|Cisplatin/Gemcitabine|Cisplatin/Gemcitabine, as per standard of care
15880658|NCT03800134|Drug|Pemetrexed/Cisplatin|Pemetrexed/Cisplatin, as per standard of care
15880659|NCT03800134|Drug|Pemetrexed/Carboplatin|Pemetrexed/Carboplatin, as per standard of care
15880660|NCT03800121|Biological|Blood samples|"Localized sarcoma group : 1 blood sample during inclusion (7 ml) + 1 blood sample before surgery (32 ml) + 1 blood sample 1 month after surgery (32 ml) + 1 blood sample 3 month after surgery (32 ml) + 1 blood sample 6 month after surgery (32 ml)
~Metastatic sarcoma group : 1 blood sample during inclusion (7 ml) + 1 blood sample during chemotherapy cure 1 (32 ml) + 1 blood sample during chemotherapy cure 3 (32 ml) + 1 blood sample during chemotherapy cure 6 (32 ml)"
15880661|NCT03800108|Procedure|Personalized DBS adjustments|Individualized stimulation adjustments based on pre- and post- DBS implantation MRIs
15881939|NCT03789916|Drug|Ticagrelor|90 mg bis in die
15880662|NCT03800095|Drug|Early palliative care integration|The follow-up time for each patient is 12 months with evaluation of the main objective by a standardized questionnaire: The Functional Assessment of Cancer Therapy-Anaemia (FACT-An) Scale at 6 months. Throughout the study, patients included will receive conventional haematological care and the interventional arm will benefit in addition to a monthly consultation by a palliative care team.
15880663|NCT03800082|Behavioral|at heart (changed from HEARTPA♀N during usability testing)|An integrated smartphone and web-based intervention (at heart) to provide evidence-informed symptom triage and self-management support to reduce pain and increase health-related quality of life (HRQoL) in women with heart disease. The intervention for participants randomized to the treatment group will consist of regular use of a progressive WebApp that is managed by a Chatbot named 'Holly', in addition to usual care, for a period of 3 months.
15880664|NCT03800069|Device|Group K Diagnostic point of care device|Arm 1 will have a finger prick sample collected to test the ability of Group K Diagnostic point of care device and app to identify liver function values.
15880665|NCT03800030|Device|Theta-gamma tACS|NeuroConn technologies, direct current-stimulator plus
15880666|NCT03800030|Device|Delta-beta tACS|NeuroConn technologies, direct current-stimulator plus
15880667|NCT03800030|Device|Sham tACS|NeuroConn technologies, direct current-stimulator plus
15880668|NCT03800017|Biological|Hyperoxia|Participants breathe 60% oxygen during exercise
15880669|NCT03799991|Behavioral|Vestibular physical therapy|Vestibular therapy is a set of exercises delivered by a physical therapist involving head movements. The therapy is delivered over a course of 8 weeks.
15880670|NCT03799991|Behavioral|Active control|Strength and flexibility exercises that do not involve head movements.
15880671|NCT03799978|Drug|ACT-541468|ACT-541468 50 mg film-coated tablets
15880672|NCT03799965|Other|ERAS (Enhanced Recovery After Surgery ) are evaluated|In this arm ERAS( Enhanced Recovery After Surgery) protocol will be inserted.The findings regarding the patients under ERAS protocol are evaluated based on evidence.
15880673|NCT03799965|Other|ERAS are not evaluated|In this arm ERAS( Enhanced Recovery After Surgery) protocol will not be inserted.The findings regarding the patients under ERAS protocol are evaluated based on evidence.
15880674|NCT03799952|Behavioral|Zoomers on the Go Exercise Program|60 minute exercise class involving resistance and aerobic training activities, as well as flexibility and balance activities. An educational handout is offered at the end of every class, relating to health behaviour.
15880675|NCT03799939|Device|Intervention group|Polyvinylidene fluoride mesh (Dynamesh IPST) is used on intraperitoneal onlay position to prevent parastomal hernia.
15880676|NCT03799926|Drug|patiromer|Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1)
15880677|NCT03799926|Drug|patiromer|Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1)
15880678|NCT03799926|Drug|placebo|Placebo starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1)
15880679|NCT03799926|Drug|placebo|Placebo starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 1)
15880680|NCT03799926|Drug|patiromer|Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 2)
15880681|NCT03799926|Drug|patiromer|Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 2)
15880682|NCT03799926|Drug|patiromer|Patiromer starting dose: 1 packet/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 3)
15880683|NCT03799926|Drug|patiromer|Patiromer starting dose: 2 packets/day, orally, once daily. The dose of patiromer could be titrated based on subject's serum potassium response (stratum 3)
15880684|NCT03799913|Biological|anti-MESO CAR-T cells|Retroviral vector-transduced autologous T cells to express anti-MESO CARs
15880685|NCT03799913|Drug|Fludarabine|30mg/m2/d
15880686|NCT03799913|Drug|Cyclophosphamide|300mg/m2/d
15880687|NCT03799900|Drug|Rapastinel|During the Treatment Phase in Part 2, participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner.
15880688|NCT03799900|Drug|Ketamine|"Part 1
~Part 2, Qualification Phase:
~Participants will be administered single IV doses of ketamine and placebo in a randomized crossover manner
~Part 2, Treatment Phase:
~Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner."
15880689|NCT03799900|Drug|Placebo|"Part 1
~Part 2, Qualification Phase:
~Participants will be administered single IV doses of ketamine and placebo in a randomized crossover manner
~Part 2, Treatment Phase:
~Participants will be administered single IV doses of rapastinel, ketamine, and placebo in a randomized crossover manner."
15880690|NCT03799887|Behavioral|0% unweighed BWSTT|"30 minutes conventional rehabilitation program (CRP) including range of motion, stretching and strengthening exercises for upper and lower extremities, balance and mobility exercises.
~After CRP, participants were provided 30 minutes 0% unweighed BWSTT sessions including a 5 minutes warm - up and cool - down period for each session, 5 days a week, for 6 weeks (totally, 30 sessions)."
15880691|NCT03799887|Behavioral|10% unweighed BWSTT|"30 minutes conventional rehabilitation program (CRP) including range of motion, stretching and strengthening exercises for upper and lower extremities, balance and mobility exercises.
~After CRP, participants were provided 30 minutes 10% unweighed BWSTT sessions including a 5 minutes warm - up and cool - down period for each session, 5 days a week, for 6 weeks (totally, 30 sessions)."
15880692|NCT03799887|Behavioral|20% unweighed BWSTT|"30 minutes conventional rehabilitation program (CRP) including range of motion, stretching and strengthening exercises for upper and lower extremities, balance and mobility exercises.
~After CRP, participants were provided 30 minutes 20% unweighed BWSTT sessions including a 5 minutes warm - up and cool - down period for each session, 5 days a week, for 6 weeks (totally, 30 sessions)."
15880693|NCT03799874|Drug|Inhaled Carbon Monoxide at 200 ppm|Inhaled Carbon Monoxide at 200 ppm for 90 minutes daily for 3 days.
15880694|NCT03799874|Other|Inhaled Medical air|Inhaled Medical Air for up to 90 minutes daily for 3 days.
15881940|NCT03789916|Drug|acetylsalicylic acid|100 mg die
15880695|NCT03799861|Other|Epoch 2: HBB with NeoBeat|At the beginning of Epoch 2, all birth attendants in each of the 3 maternity units will participate in a 2 day workshop in Kinshasa in French that will include instructions regarding use of NeoBeat and training in HBB 2.0. Participants will be introduced to NeoBeat, which will include practice with NeoBeat using the NeoNatalie newborn simulator. This training will be conducted in French using typical adapted training materials for this program that incorporate placement of NeoBeat at appropriate times in the algorithm, including a flipchart and NeoNatalie. Participants will complete the pre and post knowledge check questionnaire for the training as well as the Observed Standardized Clinical Exams (OSCEs) with the incorporation of use of NeoBeat into the OSCEs.
15880696|NCT03799861|Other|Epoch 3: HR-guided HBB|At the beginning of Epoch 3, all birth attendants in each of the 3 maternity units will participate in a 1 day workshop in Kinshasa in French that will instruct them in an adapted, HR-guided HBB algorithm. This training will include simulation with NeoNatalie and NeoBeat. Participants will complete a pre and post knowledge check questionnaire for the training as well as the Observed Standardized Clinical Exams (OSCEs).
15880697|NCT03799848|Drug|Vadadustat|Oral tablet
15880698|NCT03799835|Drug|BCG|Intravesical administration OncoTice wil be used only under two conditions : BCG Medac® unavailable and the patient has received at minimum one instillation of BCG Medac®
15880699|NCT03799835|Drug|Atezolizumab|IV perfusion
15880700|NCT03799822|Drug|Rivaroxaban 10 MG Oral Tablet|replacement of warfarin by rivaroxaban
15880701|NCT03799822|Dietary Supplement|MK-7 2000µg thrice weekly|dietary supplement of vitamin K2 MK-7 2000µg thrice weekly
15880702|NCT03799822|Drug|Vitamin K Antagonist - Drug|treatment with a vitamin K antagonist
15880703|NCT03799809|Drug|Intrabronchial Voriconazole instillation|Efficacy of intrabronchial voriconazole instillation for inoperable pulmonary aspergilloma
15880704|NCT03799796|Behavioral|Flash Glucose Monitoring with Online Peer Support|Hispanic Adults who are Spanish-Speaking with type 2 diabetes who are not using insulin will be asked to use flash glucose monitoring and to sign up for an moderated online peer support group where they can ask questions and share progress.
15880705|NCT03799783|Drug|dexmedetomidine|To administer dexmedetomidine IV 2 μg/kg in 10 minutes (loading dose) followed by continuous infusion at a rate of 1 μg/kg/h until procedure was complete
15880706|NCT03799770|Diagnostic Test|measurment of optic nerve sheath diameter by ultrasound|Sonographic measurement of ONSD was performed with the same manner of previous studies. Patients were placed in the supine position with their eyes closed, and a thick gel layer was applied to the closed upper eyelid. The 7.5-MHz linear probe was placed on the gel without excessive pressure and adjusted to the proper angle for displaying the entry of the optic nerve into the globe. The intensity of the ultrasound was adjusted to display optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band. An ultrasound beam was focused on the retrobulbar area using the lowest possible acoustic power that could measure ONSD. The ONSD was measured 3 mm behind the optic disc. Measurements were performed in the transverse and sagittal planes of both eyes, and the ﬁnal ONSD value was calculated by averaging 4 measured values.
15880707|NCT03799757|Drug|40ml of 0.25% bupivacaine|
15880708|NCT03799757|Drug|40ml of 0.9% normal saline|
15880709|NCT03799744|Genetic|VCN-01|Dose level 1: 3.3x10^12 viral particles/patient and Dose level 2: 1x10^13 viral particles/patient
15880710|NCT03799744|Biological|Durvalumab|Dose: 1500 mg Q4W
15880711|NCT03799731|Drug|GM102 antibody|GM102 7 mg/kg weekly
15880712|NCT03799731|Drug|Trifluridine/Tipiracil|Lonsurf 35 mg/m² twice daily during 10 days per cycle
15880713|NCT03799718|Biological|NurOwn (MSC-NTF cells)|Autologous Mesenchymal Stem Cells Secreting Neurotrophic Factors
15880714|NCT03799692|Drug|Chemotherapy|"Drug: Nanoparticle Albumin-Bound Paclitaxel Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, d1, 8, 15.
~Drug: Carboplatin AUC=2 iv, d1, 8, 15."
15880715|NCT03799679|Drug|Chemotherapeutic Agent|"Drug: Nanoparticle Albumin-Bound Paclitaxel Nanoparticle Albumin-Bound Paclitaxel 125mg/m2, iv, d1. Patients will receive this as a single-agent for the first twelve weeks, then followed by epirubicin in combination with cyclophosphamide.
~Drug: Epirubicin 90 mg/m² given IV
~Drug: Cyclophosphamide 600 mg/m² given IV"
15880716|NCT03799666|Other|Pulmonary Rehabilitation|Patients will be treated with daily medication prescribed by the physician. Additionally patients will participate in a 12-w.eek community-based pulmonary rehabilitation programme, with two exercise training sessions per week and six psycho-education sessions, managed by a multidisciplinary team, once every two weeks. Patient's families will be invited to participate in the psychoeducational component
15880717|NCT03799666|Other|Daily medication|Patients will be treated with daily medication prescribed by the physician and will continue to receive the standard care from the primary care centre team.
15880718|NCT03799653|Other|No intervention|This is a prospective observational study, and there is no intervention.
15880719|NCT03799640|Other|Standard Yoga|Yoga using standard poses and linear movements
15880720|NCT03799640|Other|Multi-directional Yoga|The multidirectional yoga training program will use both simple and complex movement sequences (asana or postures) that include a cognitive component. For example, participants will be taught a movement sequence that includes 16-20 yoga postures that increase in difficulty as the training progresses.
15880721|NCT03799640|Other|Educational Control|Lectures on health and fitness
15880722|NCT03799627|Drug|Vadadustat|Vadadustat Tablets 150 mg
15880723|NCT03799627|Drug|Epoetin Alfa|Epoetin Alfa
15880724|NCT03799627|Drug|Vadadustat TIW|Oral vadadustat
15880725|NCT03799614|Device|RMBand lower dose|Light-weight portable device that delivers low dose vibration to the arm
15880726|NCT03799614|Device|RMBand higher dose|Light-weight portable device that delivers higher dose vibration to the arm
15880727|NCT03799601|Drug|Anlotinib|Anlotinib which has shown an affirmatory efficacy in ALTER0303 controlled trial as a 3rd-line treatment on advanced NSCLC is a tyrosine kinase inhibitor with a favorable safety profile in phase I trial which mainly targets VEGFR1/2/3, FGFR, PDGFR and c-kit.
15880728|NCT03799601|Drug|Docetaxel|a chemotherapy medication used to treat a number of types of cancer.This includes breast cancer, head and neck cancer, stomach cancer, prostate cancer and non-small-cell lung cancer.It may be used by itself or along with other chemotherapy medication.It is given by slow injection into a vein.
15881182|NCT03795805|Drug|Intaarticular lidocain|20 ml of 2% lidocain application intraarticular before surgery (intraarticular lidocain)
15880729|NCT03799601|Drug|Carboplatin|Carboplatin is used to treat a number of forms of cancer. This includes ovarian cancer, lung cancer, head and neck cancer, brain cancer, and neuroblastoma. It may be used for some types of testicular cancer but cisplatin is generally more effective.
15880730|NCT03799588|Device|Biphasic Chest Cuirass|Patients will have a esophageal manometer placed after intubation and before initiation of negative pressure ventilation.
15880731|NCT03799575|Behavioral|Transmission Electron Microscopy analysis|Morphology of two vitreal side of Internal Limiting Membrane in contact
15880732|NCT03799562|Drug|Pregnenolone|Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial. Placebo will be identical to the pregnenolone arm, except placebo will be dispensed.
15880733|NCT03799562|Drug|Placebo|Same as pregnenolone (active study medication), except placebo dispensed.
15880734|NCT03799536|Drug|Sotalol|Sotalol, Tablets,160 mg, manufactured by Pharmtechnology LLC, Belarus
15880735|NCT03799536|Drug|Sotalex|Sotalex, Tablets,160 mg, manufactured by Bristol-Myers Squibb GmbH & Co. KGaA, Germany
15880736|NCT03799523|Other|Temporary skin markings|To use temporary markings in lieu of localization tattoos.
15880737|NCT03799523|Other|Surface imaging|To use light-based surface imaging for patient positioning during radiation treatment.
15880738|NCT03799510|Biological|Sm14|Three 0.5 mL intra-muscular injections of the vaccine solution (50μg Sm14) will be administered on D0, W4, W8 (D = day, W = week).
15880739|NCT03799510|Drug|GLA-SE solution|The lot concentration 10μg/mL for injection of 2.5μg GLA-SE/injection.
15880740|NCT03799484|Drug|Botulinum toxin type A|Botulinum toxin type A will be administered to both sides
15880741|NCT03799484|Drug|2.5% lidocaine/2.5% prilocaine|2.5% lidocaine/2.5% prilocaine will be applied to one side of the forehead
15880742|NCT03799484|Device|petrolatum ointment|petrolatum ointment will be applied to one side of the forehead
15880743|NCT03799458|Device|Active High-definition transcranial direct current stimulation (HD-tDCS)|Active HD-tDCS delivers active current through 2-10 electrodes held against the scalp with a lycra cap at specified 10-20 electroencephalography (EEG) coordinates.
15880744|NCT03799458|Device|Sham High-definition transcranial direct current stimulation (HD-tDCS)|Sham HD-tDCS delivers sham current through 2-10 electrodes held against the scalp with a lycra cap at specified 10-20 electroencephalography (EEG) coordinates
15880745|NCT03799445|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
15880746|NCT03799445|Biological|Ipilimumab|Given IV
15880747|NCT03799445|Biological|Nivolumab|Given IV
15880748|NCT03799445|Other|Quality-of-Life Assessment|Ancillary studies
15880749|NCT03799445|Other|Questionnaire Administration|Ancillary studies
15880750|NCT03799432|Other|COAST-IS|COAST-IS has been designed to equip organizations with the knowledge, motivation, and skill needed to thoughtfully match implementation strategies to identified determinants by applying intervention mapping. The COAST-IS intervention will include four different modes of delivery: 1) dissemination of educational materials; 2) five web-based interactive education sessions on the need for tailoring implementation strategies and the application of intervention mapping; 3) site visits to discuss change objectives necessary to successfully implement trauma-focused cognitive behavioral therapy; and 4) organizational coaching related to using an intervention mapping approach.
15880751|NCT03799432|Other|TF-CBT Learning Collaborative|The learning collaborative model was adapted from the Breakthrough Series Collaborative model. Leadership of the collaboratives includes experts in evidence-based practices, implementation, and quality improvement. Main components include: 1) three face-to-face learning sessions (2-days each) that provide clinical training; 2) post-learning session action periods structured to facilitate therapists' application of learned skills; 3) a secure website to facilitate faculty-to-participant and peer-to-peer learning and document use of quality improvement methods; 4) fidelity monitoring and coaching; 5) a senior leader track supporting organizational change; 6) monthly outcomes monitoring; and 7) sustainability planning.
15880752|NCT03799419|Behavioral|Cognitive bias modification for interpretation bias|Eight sessions of scenario-based CBM-I training for OCD will be administered, based on the widely-used paradigm of ambiguous scenario training developed by Mathews and Mackintosh (2000), in which participants are presented with scenarios that are ambiguous in whether or not they are threatening. Participants will complete a computer task consisting of a series of written scenarios designed to improve interpretation and attributional biases; these scenarios conclude with word fragments, which participants must fill in to resolve the ambiguity.
15880753|NCT03799419|Behavioral|Psychoeducation|Eight sessions of psychoeducation will be administered, which will describe symptoms of anxiety, the nature of biased thinking in anxiety, and summarize common psychosocial as well as pharmacological treatments for anxiety. The sessions will provide relevant information but will not provide training in changing thinking styles.
15880754|NCT03799419|Behavioral|Approach avoidance training|Eight sessions of this computerized training program will be used to train approach tendencies, following previously validated procedures (Najmi, Kuckertz, & Amir, 2010). During the training program, participants will view a series of these images and be prompted to push or pull a joystick according to prompts on the screen, instead of the content of the picture. Avoidance will be stimulated through both pushing away (images on the screen will decrease in size upon the joystick being pushed), and approach will be stimulated through pulling towards pictures (images will increase in size to simulate approach).
15880755|NCT03799419|Behavioral|Inactive sham approach avoidance training|Eight sessions of the approach avoidance training will be administered, however the percentage of push vs pull trials will be altered in this sham version of the training.
15880756|NCT03799406|Drug|Cholecalciferol|Therapeutic trial of vitamin D supplementation during acute episode of bronchiolitis
15880757|NCT03799406|Other|Placebo|Placebo supplementation during acute episode of bronchiolitis
15880758|NCT03799393|Behavioral|CIAS (Computer Intervention Authoring Software)|This is a digital application that allows families to interact with a tablet computer to receive educational information customized to the patient's age and size. allows authors to develop screening, assessment, and intervention tools for patients without requiring new programming. The CIAS intervention is programmed using tailored branching logic to allow a custom path through the intervention based on the respondent's answers. Delivery of the intervention uses a two-dimensional avatar narrator character that mimics the conversational structure of person-delivered brief interventions.
15880759|NCT03799393|Behavioral|Standard Printed Discharge Instructions|Patients/families will receive standard, printed discharge instructions. This is a 5 page general document from our Injury Prevention Center that describes appropriate car restraint safety for all age groups, not specific to the child enrolled.
15880760|NCT03799380|Dietary Supplement|Gatorade G2|Gatorade (G2), 20 oz. bottle, daily through the entire course of radiation therapy (approximately 5-7 weeks)
15880761|NCT03799380|Dietary Supplement|Standard of care nutritional support|Standard of care nutritional support
15880762|NCT03799367|Device|Drug delivery during breastfeeding|This study aims to give a vitamin B12 supplement to babies during breastfeeding. 30 mother-infant pairs will be recruited. The supplement will be placed into a nipple shield, both of which are commercially available, and the mother will breastfeed her baby as usual. Before and after the feed, we will 1) collect a small blood sample from the baby to see whether the vitamin levels in the infant have increased, 2) ask the mother to participate in two short interviews about her expectations and experiences using the Therapeutic Nipple Shield.
15880763|NCT03799354|Other|Maximal strenght training (MST) plus endurance training (ET)|"Patients will perform an addictive out-patients rehabilitative treatment of 8 weeks (3 times/week, ≥20 training sessions) consisting of:
~MST- It will consist of four sets of five repetitions on a leg-press with a focus on the rate of force development during the concentric contraction of the quadriceps from a 90° to legs complete extension. The load will be 85-90% of 1RM. When a patient will be able to perform more than five repetitions in a set, the load will be increased. All strength training will be performed on a seated horizontal leg press.
~ET - A cycling session will follow the MST and last 40 minutes at constant-load, starting from a load intensity corresponding to patient specific AT. The intensity will be gradually increased with a symptom-based progression."
15880764|NCT03799354|Other|Endurance training (ET)|"Patients will perform a usual out-patients rehabilitative treatment of 8 weeks (3 times/week, ≥20 training sessions). They will perform ET by cycling sessions that will last 40 minutes/each at constant-load, starting from a load intensity corresponding to patient specific AT, assessed during the baseline incremental test. The intensity will be gradually increased during the sessions with a symptom-based progression, according to the protocol by Maltais and coworkers. A 3-min warm-up and cool-down will be provided. Heart rate (HR), blood pressure, oxygen pulsoxymetry, and symptoms by Borg CR10 scale will be monitored at the beginning and end of each session.
~Out of the training-days, both groups will continue their normal daily living with modest regular activity, as recommended by their physician."
15880765|NCT03799341|Behavioral|Prize-Based Contingency Management|"Participants assigned to Prize-based Contingency
~Management (PBCM) conditions will receive PBCM as an adjunct to TAU. PBCM will involve twice weekly one-on-one sessions with a provider for 12-weeks. During each session, a urine specimen provided by the patient will be tested for cocaine using a point-of-care dip-test. Results of point-of-care testing will be shared with the patient and negative results will be reinforced with draws from a fish bowl containing 500 paper slips, 250 of which award small, large, or jumbo prizes (remaining slips deliver words of encouragement). Patients will be reinforced with a single prize draw for their first negative specimen; an additional prize draw will be added for each consecutive negative result (up to 8
~prize draws per session). Abstinence-contingent prize draws will be reset to one upon either a positive test result or unexcused, missed appointment."
15880766|NCT03799341|Behavioral|Treatment As Usual Outpatient Substance Use Treatment|All participants will receive treatment as usual outpatient substance use services during the 12-week treatment interval. TAU will specifically entail recommended participation in at least two outpatient group and/or individual psychotherapy encounters per week within the Center for Treatment of Addictive Disorders (CTAD) at VA Pittsburgh Healthcare System. Participants will additionally continue any previously prescribed pharmacotherapy for substance use and/or other mental health conditions, if applicable.
15880767|NCT03799328|Other|multi-OIT|low dose OIT to multiple foods
15880768|NCT03799315|Drug|Nicotine Replacement Therapy|All participants randomized to the JUST group will receive training on proper use of nicotine lozenges to aid in smoking cessation. Upon release from jail, participants will receive 2mg nicotine lozenges.
15880769|NCT03799315|Behavioral|Counseling|All participants randomized to the JUST group will receive one hour of in-person, individual, guideline-based smoking cessation counseling during their jail stay. Upon release from jail, they will receive four 30-minute counseling phone calls over 3 weeks. These phone calls will take place at 24 hours, day 7, day 14, and day 20.
15880770|NCT03799302|Behavioral|SIC Coaching|Sites receiving consultation to implement either TFCO or MDFT will also receive consultation on their implementation fidelity as measured and tracked by the SIC.
15880773|NCT03799276|Other|Opticare study|"Each patient will be evaluated by
~An HIV physician
~A nurse
~A social worker
~A psychological therapist
~A cultural mediator/member of patients community if needed for migrants
~Following these interviews and visits, a multisciplinary team will define for each patient an individualized OPTICARE program based on the following items: clinical, psychological/psychiatric, social status and follow up visits will be planned with the patient.
~Regular (Day 15 and monthly) phone calls will be set up during the first six months of the OPTICARE program, to assess the clinical status and ART adherence.
~Patients will have their medical, biological and social status assessed through visits at W4, W12, W24, W36 (medical and social status only) and W 48 with all members of the OPTICARE team."
15880774|NCT03799263|Procedure|evaluation group|Recordings Pneumologic assessment Severity grades (I-IV: old GOLD and A-D: new GOLD) Smoke History Drug therapy Comorbidities 6MWT performed within previous 10-14 months, if available. Measurements Standard exams usually performed at Rehab Center Lung Function tests and diffusing capacity of the lung for carbon monoxide Arterial Blood Gases Dyspnoea Health Status and Health Related Quality of Life Daily activity Lower limb muscle strength Exercise capacity
15880775|NCT03799250|Drug|Ringer lactate|Comparison between fluid maintenance in PACU compared to a bolus based goal directed hemodynamic therapy in the PACU
15880776|NCT03799250|Other|standard care|standard care
15880977|NCT03797508|Diagnostic Test|ultrasound|To evaluate the accuracy of ultrasound findings in comparison to serum CA125and progesterone in predicting fetal demise in cases of first trimester threatened miscarriage.
15880777|NCT03799237|Other|GOS trap and dengue NS1 antigen kit|The GOS trap lure and sticky surfaces to trap gravid Aedes mosquitoes. Three GOS traps will be placed on every 3 floors of the residential blocks. The traps will be changed weekly. Trapped Aedes mosquitoes will be identified to species. The mosquitoes will then be dissected, to remove the abdomen from the thorax. Five to seven abdomens of the same mosquito species will be pooled and tested for dengue NS1 antigen using the SD Biosensor Standard Q dengue NS1 antigen test kit. If the pool is tested positive for dengue NS1, the head and thorax of the respective abdomens will be subjected to the same procedure for dengue NS1 antigen test, individually. This may allow us to identify a focus where there could be dengue-infected individuals. Flyers/Posters will be disseminated besides, house-to-house approach to inform the residents of the findings and apartment blocks where these mosquitoes were found. The apartment management will also make use of social media disseminate this information.
15880778|NCT03799224|Drug|Decitabine|Decitabine 200mg.m-2.d-1 intravenously on days -12 and -11
15880779|NCT03799224|Drug|mBU/CY and ATG|Ara-C 4 g·m-2·d-1 intravenously on days -10 to -9 Busulfan (BU 3.2 mg·kg-1·d-1) intravenously on days -8 to -6, Cyclophosphamide (CY 1.8 g·m-2·d-1) intravenously on days -5 to -4 Semustine (Me-CCNU, 250 mg·m-2) orally once on day -3 ATG (2.5 mg·kg-1·d-1) intravenously on days -5 to -2
15880780|NCT03799224|Drug|mBU/CY|hydroxycarbamide (80 mg·kg-1) orally on day -10 Ara-C (2 g·m-2·d-1) on day -9 Busulfan (BU 3.2 mg·kg-1·d-1) intravenously on days -8 to -6, Cyclophosphamide (CY 1.8 g·m-2·d-1) intravenously on days -5 to -4 Semustine (Me-CCNU, 250 mg·m-2) orally once on day -3
15880781|NCT03799211|Behavioral|Motivational Interviewing|Phone call using motivational interviewing technique
15880782|NCT03799211|Behavioral|Treatment as Usual|will receive a regular study phone call after three months
15880785|NCT03799172|Drug|Echinocandin treatment|Patients received echinocandins as a first-line therapy after candidemia diagnosis according to the standard of care
15880786|NCT03799172|Drug|Triazole treatment|"Patients received triazoles as a first-line therapy after candidemia diagnosis according to the standard of care.
~Candidemia was defined as at least one blood culture positive for Candida."
15880787|NCT03799146|Behavioral|MyPlan 2.0|MyPlan 2.0 consists of five sessions. During these five sessions the following behaviour change techniques are used to motivate users to be more physically active or to sit less: exploring risk perceptions and perceived benefits, exploring social support, providing feedback, action planning, coping planning and monitoring.
15880788|NCT03799146|Other|Waiting List|Waiting List control group
15880789|NCT03799133|Device|Florence device|The Florence catheter will be placed at the beginning of the surgery and up to 72 hours in ICU.
15880790|NCT03799120|Drug|Tamsulosin BID|comparison of once daily versus twice daily tamsulosin
15880791|NCT03799120|Other|Placebo|Placebo
15880792|NCT03799094|Drug|Vitamin C|Participants will receive intravenous vitamin C therapy at the indicated dose.
15880793|NCT03799094|Drug|Tyrosine kinase inhibitor|Participants will receive Tyrosine kinase inhibitor therapy in cycles: continuous treatment at the indicated dose.
15880794|NCT03799081|Procedure|Fetoscopy|Fetoscopy is a procedure that enables viewing of the fetus through use of a hysteroscope
15880795|NCT03799068|Other|suprazygomatic maxillary nerve block|bilateral Suprazygomatic maxillary nerve block is performed before surgery in anaesthetized children, after aseptic preparation of the skin. The patient is in supine position with the head in neutral position. The puncture site is at the frontozygomatic angle, at the junction of the upper edge of the zygomatic arch and the frontal process. A 24G needle is attached to a syringe containing the local anaesthetic. It is advanced to reach the greater wing of sphenoid at approximately 20 mm depth, then withdrawn a few millimetres and redirected toward the nasolabial fold in a 20° forward and 10° downward direction. The progression in the pterygopalatine fossa is 35 to 45 mm. Loss of resistance after passing through the temporalis muscle assisted in determining the puncture depth. After a negative blood aspiration test, the calculated dose of the local anaesthetic is injected on each side.
15880796|NCT03799068|Other|surgical site infiltration|peri-incisional infiltration of bupivacaine around the incision site given by the surgeon on an anesthetized patient before the incision is done.
15880797|NCT03799042|Device|Virtual Reality|Subjects will wear a 3D glass and watch 3D pictures (or video) of landscapes or tourist sites in Hong Kong.
15880798|NCT03799042|Behavioral|Inter-generation interaction|Secondary school student will play games and chats with secondary school students. Games involve identifying famous landscapes or tourist sites in Hong Kong
15880799|NCT03799029|Other|Cognitive training|Participants will train at home during 25 sessions (about 45 minutes each) over a maximum of 5 weeks. Investigators will verify compliance via Internet and call participants and their legal guardians once a week. A reward system will be established with participants. Five sessions of metacognition (1 hour each) are added.
15880800|NCT03799003|Drug|ASP1951|Intravenously (IV)
15880801|NCT03799003|Drug|pembrolizumab|Intravenously (IV)
15880802|NCT03798964|Other|Placental analysis|Analysis of placenta to determine expression of heparanase
15880803|NCT03798951|Other|Prehabilitation|"The patients included in the treatment group will follow a prehabilitation program, based on a physiotherapist, nutritionist and psychologist evaluation. All the treatments will be tailored according the characteristics of each single patient.
~The program will have a duration of, at least, 4 weeks."
15880804|NCT03798938|Other|plant-based diet|subjects will be placed in plant-based diet and the effect of plant-based diet to the endothelial function will be monitored
15880806|NCT03798912|Combination Product|RaniPill capsule containing octreotide|Administration of a RaniPill capsule loaded with 100 mcg of octreotide. Serial blood samples will be collected over the following 4 h for pharmacokinetic analysis of octreotide a) injected intravenously and b) delivered directly into the jejunal wall by the RaniPill capsule.
15880807|NCT03798899|Drug|Methoxyflurane|PENTHROX 3mL inhalation vapour, liquid
15880808|NCT03798899|Drug|Normal Saline|Placebo
15880809|NCT03798886|Other|natural cycle|When follicle is ready for ovulation, we will use this injection by intra-dermal route
15880810|NCT03798886|Other|modified natural cycle|we will use that drug in the natural modified transfer group after embryo transfer
15880811|NCT03798886|Other|embryo transfer|we will do transfer when the endometrium is ready
15880812|NCT03798873|Device|FeelWell™ Compression garment|"Registered FDA class I device:
~The FeelWell™ Compression garment is a custom-made orthopedic abdominal binder with full or half-body support. The garments are made of 70% polyamide and 30% elastane and OEKO-TEX certified confirming human-ecological safety of textiles. The company uses a wrap knitting to ensure an optimal compression and durability. The garment has two 360 degrees whalebones in the front and two in the back to provide support for the posture, reinforcing compression on the abdomen and lower-back."
15880813|NCT03798873|Behavioral|Increase Mobility|Subjects will work with exercise physiologist and physical therapist to increase mobility, strength and activity
15880814|NCT03798860|Diagnostic Test|blood samples|For performing the Luminex solid phase assay (SPA) test, 7.5 ml of patient whole blood are collected from a peripheral vein.
15880815|NCT03798847|Device|Journey II XR TKA|Journey II XR Total Knee System
15880816|NCT03798834|Drug|Fascia iliaca block (FIB)|ultrasound-guided Fascia iliaca block
15880817|NCT03798834|Other|Spinal anesthesia|Spinal anaesthesia using 2 ml hyperbaric bupivacaine 0.5%
15880818|NCT03798821|Dietary Supplement|Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (100MG)|six weeks of consumption
15880819|NCT03798821|Dietary Supplement|Lactobacillus rhamnosus, Lactobacillus casei y Bifidobacterium longum (300MG)|six weeks of consumption
15880820|NCT03798821|Dietary Supplement|maltodextrin and sucrose (PLACEBO)|six weeks of consumption
15880821|NCT03798808|Other|Consumption of fruits, vegetables and dairy products|Family Nutriathlon was an eight-week, family-based nutrition program where children and their parents were encouraged to reach individual and team goals with respect to the quantity and variety of fruit, vegetable and dairy product consumption.
15880822|NCT03798782|Procedure|Ross procedure|The patient will undergo the Ross procedure where the surgeon will replace the aortic valve using a pulmonary autograft (Ross procedure) with pulmonary homograft replacement of the pulmonary root. Identified Ross experts will perform all Ross procedures.
15880823|NCT03798782|Procedure|Conventional aortic valve replacement|The patient will undergo Conventional aortic valve replacement where the surgeon will replace the aortic valve with another prosthesis which can include a mechanical prosthesis, a stented biological prosthesis, a stentless biological valve or root, or a catheter valve.
15880824|NCT03798769|Other|Supportive Oncology Care at Home|"Entails the following:
~patient-reported symptoms, vital sign, and weight monitoring with appropriate triggers to phone calls and home visits by Medically Home based on a clinician-derived algorithm;
~scheduled nursing visits for intravenous (IV) hydration during the course of chemotherapy;
~regular communication with oncology clinicians regarding care delivered at home to ensure continuity of care."
15880825|NCT03798743|Drug|Sintilimab Combined With Docetaxel|Sintilimab 200mgi.v q3w Docetaxel 75mg/m2 i.v q3w
15880826|NCT03798730|Behavioral|Solid Model|"Cake and biscuit will be used, with the amount of protein varied to study the effect on perception of the products (using sensory methods of rating drying and discrimination tests which is the stronger in drying)"
15880827|NCT03798730|Behavioral|Liquid Model|"Intervention Description: To study the effect of protein denaturation on perception of whey protein beverages using sensory methods (rating drying as well as discrimination tests which is the stronger in drying). Measuring mucoadhesion via protein content remaining in saliva following swallowing of whey protein beverages."
15880828|NCT03798717|Diagnostic Test|Heating|Warm water immersion
15880829|NCT03798704|Diagnostic Test|IFA, LIAISON|Comparison of two diagnostic serological tests - IFA and LIAISON.
15880830|NCT03798691|Biological|Shingrix|"Biological: SHINGRIX
~SHINGRIX is a vaccine indicated for prevention of herpes zoster (shingles) in adults aged 50 years and older.
~SHINGRIX is a suspension for injection supplied as a single-dose vial of lyophilized glycoprotein e (ge) antigen component to be reconstituted with the accompanying vial of AS01B adjuvant suspension component. A single dose after reconstitution is 0.5 mL.
~Dose and Schedule: Two doses (0.5 mL each) administered intramuscularly according to the following schedule: A first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later.
~Other Name: Recombinant zoster vaccine"
15880831|NCT03798678|Drug|Carfilzomib|Given IV
15880832|NCT03798678|Drug|Dexamethasone|Given PO
15880833|NCT03798678|Drug|Telaglenastat Hydrochloride|Given PO
15880834|NCT03798665|Drug|Pegfilgrastim（PEG-rhG-CSF）|From the first chemotherapy cycle using PEG-rhG-CSF (which can be any chemotherapy cycle of the patient), record the use of PEG-rhG-CSF in this cycle and each subsequent chemotherapy cycle, including dosage, administration time and dosing frequency
15880835|NCT03798652|Device|Research CMR scan|CMR scanning at a 3Tesla scanner at King's College London
15880836|NCT03798652|Device|Research 3D transthoracic echocardiogram|The scan is required to assess left ventricular systolic function
15880837|NCT03798652|Other|6-minute walk test|Sub maximal exercise that provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise.
15880838|NCT03798639|Biological|Ipilimumab|Given IV
15880839|NCT03798639|Biological|Nivolumab|Given IV
15880840|NCT03798639|Radiation|Radiation Therapy|Receive radiation therapy
15881941|NCT03789903|Diagnostic Test|amniotic fluid lactate|AF lactate
15880848|NCT03798613|Device|Apple Watch 4 Series Device|tracings from the apple watch 4 series watch
15880849|NCT03798613|Device|Continuous Telemetry Monitor|tracings from the continuous telemetry monitor
15880850|NCT03798600|Drug|Caspofungin|In accordance with routine clinical practice, Caspofungin will be given at the loading dose of 70 mg followed by 50 mg daily (for people < 80 kg body weight). No dose reduction will be performed in Child-Pugh score A or B. Duration of therapy will be performed in accordance with ESCMID guidelines and clinical conditions.
15880851|NCT03798561|Drug|ASN008 TG|ASN008 TG
15880852|NCT03798561|Drug|Placebo TG|Placebo TG
15880853|NCT03798548|Behavioral|Brief Bedside CBT|4 sessions of CBT including psychoeducation about TAVR and how mood can impact recovery in cardiac patients, discussion of patients' expectations and any concerns. Teaching and practice of cognitive restructuring and behavioral goal setting techniques for a healthy recovery.
15880854|NCT03798522|Procedure|bilateral ultrasound guided erector spinae plane block|ESPB on both sides at T7 before GA
15880855|NCT03798522|Drug|Nalbuphine|in nalbuphine for analgesia after GA
15880856|NCT03798509|Drug|Human CD19 targeted T Cells Injection|Autologous genetically modified anti-CD19 CAR transduced T cells
15880857|NCT03798496|Procedure|Open reduction and internal fixation|Open reduction of the Galeazzi fracture dislocation with a plate.
15880858|NCT03798483|Other|Individualised exercise|The intervention will be comprised of up to 6, one-to-one physiotherapy sessions, over a maximum duration of 3 months. 1 or 2 extra sessions are allowed if deemed essential by the participant's physiotherapist. Less than 6 physiotherapy sessions can be agreed with the participant if they have achieved their goals. Throughout this time participants will be required to perform an exercise programme a minimum of 3 times per week. The exercise programme aims to increase leg muscle strength and facilitate a return to the participant's usual activities. It may include hopping and change of direction tasks if these are activities the participant would normally do. Behavioural change techniques to increase participant adherence to the exercise programme will also be used.
15880859|NCT03798470|Behavioral|Peer Addiction Counseling|After identification, a 24/7 on-call FRC was paged and met with the patient in the ED. The patients were offered recovery services at the bedside by the FRC. The research team members offered voluntary participation and obtained informed consent to enrolling a longitudinal study looking into the success of his intervention. Patients did not need to participate to be eligible for counseling and resources from AVOR. The FRCs counselled and engaged the patient along with the family to offer a variety of services including active recovery coaching, group treatment modalities, family support services and transportation. After he initial encounter in the ED, the FAVOR team re-engaged the participant by phone or in person the next day and gradually increasing intervals thereafter.
15880860|NCT03798457|Other|No intervention|In this study there is no intervention
15880861|NCT03798444|Radiation|dual energy X-ray absorptiometry|BMD of the lumbar spine, left femoral neck, and total hip were measured using dual energy X-ray absorptiometry. The lumbar spine, left femoral neck, or total hip of T-score ≤-2.5 as the osteoporosis
15880862|NCT03798444|Radiation|lateral spine imaging from T4 to L4 on X-ray|VFs were assessed using lateral spine imaging from T4 to L4 on X-ray .A visual semi-quantitative method was used, with fractures defined as a vertebral Vertebral fractures should be diagnose if height ratio <0.80 for the anterior/posterior or middle/posterior height ratio within a vertebra, or the posterior/posterior height ratio when compared to an adjacent vertebra
15880863|NCT03798431|Behavioral|M-ROCC|"LDM (Low-Dose Mindfulness): A 4-wk intro mindfulness program for OUD, 50 min/week including explicit training in use of mobile mindfulness apps, with rolling admission and ascending practice dose ladder.
~MTPC (Mindfulness Training for Primary Care): An eight-week intensive mindfulness group with ascending practice dose ladder and skill integration over 8 weeks & 120 minutes/wk.
~MCS (Mindfulness Maintenance Check-in Support): Ongoing weekly mindfulness group with check-in and reminders, leveraging mobile mindfulness apps and motivational counseling for grads of LDM for 50 mins/wk.
~After completion of the LDM group, participation in various levels is fluid based on patient motivation, choice, and readiness."
15880864|NCT03798418|Behavioral|elastic band strengthening exercise|2-3days per week(150min per week)
15880865|NCT03798418|Dietary Supplement|diet counseling|each patients in this group will receive4-5times diet counseling
15880866|NCT03798405|Behavioral|Proactive Analgesic Inpatient Narcotic-Sparing|Medications suggested to the physician with enhanced ease of ordering.
15880867|NCT03798392|Device|Self-pressurizing Air Q blocker mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertion|comparing the airway seal pressure 10 min after insertion of each devices .
15880868|NCT03798392|Device|Baska mask measuring airway seal pressure of studied supra-glottic airway devices 10 minutes after insertion|comparing the airway seal pressure 10 min after insertion of each devices .
15880869|NCT03798379|Other|Exercise|Strengthening, balance and aerobic exercises were explained to the patients examined before chemotherapy sessions and demonstrated by applying on the patient.
15880870|NCT03798366|Drug|GLPG1690|Film-coated tablets of GLPG1690 for oral use.
15880871|NCT03798366|Drug|Placebo|Film-coated tablets of GLPG1690 matching placebo for oral use.
15880872|NCT03798353|Combination Product|PeriCord: Expanded and cryopreserved allogeneic umbilical cord Wharton´s jelly-derived adult mesenchymal stem cells colonized on human pericardial matrix.|A matrix-cell construct (PeriCord) will be placed on the ischemic area of the non-candidate revascularization area during a surgery by sternotomy to perform the surgical revascularization of the arteries candidates for revascularization.
15880873|NCT03798353|Procedure|Surgery by sternotomy|The patient will undergo surgery by sternotomy to perform the surgical revascularization of the arteries candidates for revascularization. No additional procedure will be performed only the by-pass.
15881038|NCT03796923|Other|Comprehensive geriatric assessment (CGA)|Comprehensive geriatric assessment (CGA) during admission
15890018|NCT03727100|Combination Product|Clonidine Micropellets|Injection
15880874|NCT03798340|Other|Vibratory perturbed task-specific movement training|The perturbation-based pinch task training was conducted with the affected hand placed on the pinch device. The horizontal vibratory perturbation was generated for a total of 20 minutes by two recoil-type actuators with a frequency of 30 Hz and an amplitude of 2 mm, and intermittent exposure (10 s per 30 s). Each training session was divided into eight cycles with a training interval of 2 min per 2.5 min.
15880875|NCT03798340|Other|Traditional task-oriented facilitation|Reach-to-grasp training and hand release training
15880876|NCT03798340|Other|Sensorimotor training|Targeted to goals that are relevant to the sensorimotor facilitation of the patient
15880877|NCT03798327|Behavioral|Home Palliative Care|Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.
15880878|NCT03798314|Biological|Nivolumab|Given IV
15880879|NCT03798314|Drug|Pomalidomide|Given PO
15880880|NCT03798301|Biological|CMV-specific T-cells|Naturally occurring, allogeneic donor lymphocytes derived from a leukapheresis or a whole blood product, enriched for CMVspecific CD4+ and CD8+ T-cells
15880881|NCT03798288|Behavioral|selfBACK|Participants will use the selfBACK system and app in addition to receiving usual care
15880882|NCT03798288|Other|Usual care|Participants will receive usual care
15880883|NCT03798275|Dietary Supplement|coffee|2 g Nescafe Clasico contains approximately 65 mg caffeine
15880884|NCT03798262|Other|Gluten|Tereos
15880885|NCT03798262|Other|Placebo|Whey protein from Nestlé Healthy Science
15880886|NCT03798249|Other|Gluten|Tereos
15880887|NCT03798249|Other|Placebo|Nestlé Health Science
15880888|NCT03798236|Drug|PBF-1650 oral capsules|Adenosine A3 receptor (AA3R) antagonist
15880889|NCT03798236|Drug|Placebo oral capsule|solid microcrystalline cellulose
15880890|NCT03798223|Procedure|SLT|A drop of Pilocarpine 4% is administered to the eye 20 minutes before SLT. Immediately before SLT a drop of Tetracaine hydrochloride 1% is administered. Selective laser trabeculoplasty is conducted through a Latina lens, in a fashion determined by randomization to a study arm (see description).
15880891|NCT03798210|Dietary Supplement|Lactobacillus reuteri|Study group split in two arms for experimental treatment with Lactobacillus reuteri or placebo.
15880892|NCT03798210|Dietary Supplement|Placebo|Placebo
15880893|NCT03798197|Drug|30 mg estetrol (E4)|All subjects received both Treatment A and Treatment B either at the first treatment period (Period 1) or at the second treatment period (Period 2). Approximately half of the subjects was randomized to receive either Treatment A followed by Treatment B (sequence AB), or Treatment B followed by Treatment A (sequence BA).
15880894|NCT03798184|Procedure|Non-carious cervical lesion restoration|Restoration of non-carious cervical lesions with Prime&Bond Active in self-etch or selective-etch mode with or without bioglass
15880895|NCT03798158|Other|Multidisciplinary Dyspnea Profile questionnaire|Multidisciplinary Dyspnea Profile questionnaire at the beginning and the end of an hospitalization
15880896|NCT03798145|Procedure|Surgical Retinotomy|Surgical removal of small areas of retinal to increase outflow through the posterior drainage pathway.
15880897|NCT03798132|Diagnostic Test|laparoscopy|evaluation of peritoneal carcinomatosis by laparoscopy
15880898|NCT03798119|Drug|Tenofovir Alafenamide|Subjects in this group will switch prior nucleot(s)ide analogs to Tenofovir Alafenamide 25 mg/day for 96 weeks
15880899|NCT03798106|Drug|Durvalumab, pazopanib|Durvalumab 1500mg IV 1hr q3weeks Pazopanib 800mg QD PO q3wwks
15880900|NCT03798093|Procedure|Umbilical Cord Milking|At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 15-20 seconds.
15880901|NCT03798093|Procedure|Early Cord Clamping|The umbilical cord is clamped within 30 seconds of delivery.
15880902|NCT03798080|Drug|Insulin glargine/Lixisenatide (HOE901/AVE0010)|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
15880903|NCT03798080|Drug|Insulin glargine (HOE901)|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
15880904|NCT03798080|Drug|Metformin|"Pharmaceutical form: tablet
~Route of administration: oral"
15880905|NCT03798054|Drug|Insulin glargine/Lixisenatide (HOE901/AVE0010)|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
15880906|NCT03798054|Drug|Insulin glargine (HOE901)|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
15880907|NCT03798054|Drug|Lixisenatide (AVE0010)|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
15880908|NCT03798054|Drug|Metformin|"Pharmaceutical form: tablet
~Route of administration: oral"
15880909|NCT03798054|Drug|SGLT2 inhibitor|"Pharmaceutical form:tablet
~Route of administration: oral"
15880910|NCT03798041|Behavioral|Debridement Within 24 Hours After Surgery|Debrided within 24 hours after surgery
15880911|NCT03798028|Biological|UC-MSCs|The UC-MSCs will be administrated by intravenous injection at the dose of 1×10^6 cells/kg.
15880912|NCT03798015|Other|mitral valve surgery|assessment of ischemic or hemorrhagic stroke subsequent to mitral valve surgery
15880913|NCT03798002|Other|Neuro-muscular exercise training Group|"Training takes place 3 days a week for 8 weeks follow up, under the supervision of physical therapist A training session lasts for 40 minutes, and consists of three parts.
~PART 1:Warming up:
~warm-up period consists of ergometer cycling for 10 minutes
~PART 2: Circuit program:
~comprises four exercises, core stability/postural function; postural orientation; lower extremity muscle strength; and functional exercises. Each exercise is performed 2-3 sets 10-15 repetitions.
~PART 3:Cooling down:
~The cooling down part consists of walking exercises forward and backwards, about 10 meters in each direction, in front of mirror (mobility exercises for the lower extremity muscles for a total of about 10 minutes. Changes in patient's symptom assessed by structural questionnaire"
15880914|NCT03798002|Other|quadriceps training program|"Apply Tens (10min+ hot pack 7-10min) Before excercise ROM,Quadriceps and hamstring stretching exercise's and strengthening exercises.
~4th-6th week (in addition): Straight leg raise, Quads over a roll, Hamstring curls. 7th and 8th week (in addition): Elastic band exercise, Hamstring curls, Quads chair, isometric strengthening All exercises are performed in set of 10 repetitions. 1 set of all exercises was twice a day for first 3 week, and 2 sets twice a day until 6th week and then 3 sets twice a day until 8th week"
15881039|NCT03796923|Other|Continued geriatric care|Continued specialized geriatric care after discharge
15880915|NCT03797989|Biological|P. vivax infected inoculum (parasitised red blood cells)|In the first controlled human malaria infection (CHMI, Phase A), inoculation of parasitised red blood cells will be at three different doses (1 vial, 1:5 dilution, 1:20 dilution). The optimal inoculation dose will then be selected and administered to all participants in each of the second and third CHMI.
15880916|NCT03797976|Device|MIP and MEP|Pre-op, Post-op of, 1 month after surgery, 3 months after surgery
15880917|NCT03797963|Device|PBM+ACB|Maxillary sinus floor elevation and bone grafting with the use of porcine bone mineral biomaterial (Symbios Xenograft) combined with autogenous cortical bone
15880918|NCT03797963|Device|ABB+ACB|Maxillary sinus floor elevation and bone grafting with the use of anorganic bovine bone biomaterial (BioOss Xenograft) combined with autogenous cortical bone
15880919|NCT03797950|Behavioral|Voice Reminder (Group A)|Woman with a recent delivery will be contacted via mobile phone by a central study staff member to encourage them to vaccinate their newborn with OPV0 and BCG, and information on where and when vaccines are available in this community will be provided. Community volunteers will receive small incentives for documenting births in the community.
15880920|NCT03797950|Behavioral|Cash Incentive (Group B)|Mobile phone based monetary incentives will be provided to community volunteers and to women with a recent delivery who vaccinate newborns with OPV0 and BCG on time. Community volunteers will receive small incentives for documenting births in the community.
15880921|NCT03797937|Other|Magnetic resonance imaging (MRI)|MRI scanner
15880922|NCT03797924|Drug|Receive ICBN with ropivacaine|ICBN block will be performed using US guidance depositing 10 ml of 0.5% ropivacaine in the plane between pectoralis minor and serratus anterior over the 2nd and 3rd intercostal space.
15880923|NCT03797924|Behavioral|No ICBN block|The site of injection will be prepped with tinted chlorhexidine
15880924|NCT03797911|Combination Product|Active resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education|Activated resistive capacitive monopolar radiofrequency is applied to the patient along with the conventional treatment of physiotherapeutic techniques and pain education.
15880925|NCT03797911|Combination Product|Inactive resistive capacitive monopolar radiofrequency with physiotherapeutic techniques and pain education|Disactivated resistive capacitive monopolar radiofrequency inactived is applied to the patient along with the conventional treatment of physiotherapeutic techniques and pain education.
15880926|NCT03797898|Other|Parent Coach|The Parent Coach intervention uses a health educator who provides anticipatory guidance, psychosocial screening/ referral, and developmental/behavioral surveillance, screening, and guidance at each well-visit. The Parent Coach uses a parent-focused, pre-visit questionnaire to customize the visit to the parents' needs. Every well-visit includes a brief, problem-focused encounter with a clinician for a physical exam and any concerns that require a clinician's attention. Finally, an automated text message service provides for periodic, age-specific messages to reinforce key health messages from Parent Coach-led well-visits.
15880927|NCT03797885|Other|No treatment given|No treatment is administered to the participants for this study
15880928|NCT03797872|Drug|Methotrexate|Methotrexate up to 25mg/week as tolerated po or sc
15880929|NCT03797872|Drug|Sulfasalazine|Sulfasalazine up to 3g daily po
15880930|NCT03797872|Drug|Leflunomide|Leflunomide 10-20mg daily po
15880931|NCT03797872|Drug|Methylprednisolone|For IA or IM injection 20-120mg
15880932|NCT03797872|Drug|Triamcinolone|For IA or IM injection 20-120mg
15880933|NCT03797859|Procedure|Apneic ventilation|Ventilation by THRIVE
15880934|NCT03797846|Procedure|combined glaucoma surgery|combined procedure with trabeculectomy and cataract removal
15880935|NCT03797833|Procedure|Spinal Anaesthesia|Spinal anaesthesia with Bupivacain 2.5 mg and Sufentanil 5 µg
15880936|NCT03797820|Other|Our study type is observational|Our study type is observational
15880937|NCT03797807|Procedure|MINST|A non-surgical minimally invasive treatment protocol, named MINST, has been proposed for the treatment of periodontal intrabony defects, in order to minimize patient discomfort and maximize the healing potential
15880938|NCT03797807|Procedure|MIST|A minimally invasive surgical treatment protocol, named MIST, has been proposed for the treatment of periodontal intrabony defects, in order to minimize patient discomfort and maximize the healing potential
15880939|NCT03797807|Diagnostic Test|GTI subgroup (Geometrical/Thermal Imaging)|Geometrical/Thermal Imaging
15880940|NCT03797794|Device|Pulsating Electrostatic Field|A pulsating electrostatic field is generated by the New Health 9000 (Akern). During the session the patients sits on a chair which contains the apparatus for 30 minutes.
15880941|NCT03797794|Device|SHAM Pulsating Electrostatic Field|The same apparatus which produces the pulsating electrostatic field contains a 'sham-inlet'. This inlet will be used as placebo.
15880942|NCT03797781|Other|Lower limb immobilisation (leg brace) with varying levels of protein intake|Single leg immobilisation via leg brace and crutches, the groups have different amounts of protein intake
15880943|NCT03797768|Behavioral|Behavioural-FCHV Visit|Female Community Health Volunteer will visit selected households on average 3 times a year for providing health promotion messages on improving lung health status and avoiding risk factors to COPD.
15880944|NCT03797755|Radiation|palliative radiotherapy|Radiotherapy for palliating symptoms in stage IV cancer patients
15880945|NCT03797729|Drug|Tirofiban|Upon being diagnosed as ST Elevation Myocardial Infarction, if informed consent is obtained, patients start to receive Tirofiban(0.05mg/ml) intravenous drip in a dosage of 4ml/hour (patients weight<50kg) or 6ml/hour (patients weight > 50kg) lasting for 24 hours.
15880946|NCT03797729|Drug|Normal saline|Upon being diagnosed as ST Elevation Myocardial Infarction, if informed consent is obtained, patients start to receive normal saline intravenous drip in a dosage of 4ml/hour (patients weight<50kg) or 6ml/hour (patients weight > 50kg) lasting for 24 hours.
15880972|NCT03797560|Drug|Pregabalin capsule|Pregabalin is one of the three medications (pregabalin, duloxetine, and milnacipran) that have been approved by the Food and Drug Administration (FDA) to treat fibromyalgia in US, and the only medicine that has been approved in China.
15880973|NCT03797547|Other|AFLIBERCEPT|Patients will be treated following a real life protocol and according to the French recommendation
15880974|NCT03797534|Other|dose regime|The initial dose of the experimental group will be calculated by the Bayesian model.
15880947|NCT03797716|Device|Little Journey app|"The Little Journey app allows children to explore 360-degree hospital environments familiarising and desensitising them to areas and staff they'll see on the day of surgery. Children can visit the day case ward, anaesthetic and recovery rooms where their operation will occur -all while feeling safe in their own home. As the child explores the three areas, they are introduced to animated characters of staff who explain what will happen, the equipment that will be used and how they might feel. Using head tracking technology, the child triggers the animated characters by looking at them; meaning they control the pace of learning and speed at which they progress. The preparatory tool follows a pre-set story-line reflecting what happens from admission to discharge on the day of surgery."
15880948|NCT03797703|Drug|Lidocaine Hydrochloride 2% gel enema|Insertion of Lidocaine Hydrochloride 2% gel enema rectally immediately following the procedure.
15880949|NCT03797690|Procedure|Percutaneous needle aponeurotomy|It consists in cutting the fibrotic cord due to the disease and responsible for the flexion contracture, with a needle under local anesthesia. The procedure can be repeated as required during the same session. One to three sessions with at least one-week interval are usually sufficient and will be allowed. It will be performed in outpatient setting by a senior physician experienced in the procedure
15880950|NCT03797690|Procedure|Open surgery with limited aponeurectomy|It consists in excision of the fibrotic aponeurosis.It will be performed by hand surgeons under loco-regional anaesthesia during a short hospitalization (1 day stay). Post-operative cares are necessary (analgesics, splint, nursing, physiotherapy)
15880951|NCT03797677|Device|MN 4000|Patients who required regular home airway clearance therapy were enrolled in the study and were prescribed therapy with the MN4000. Adherence to the prescribed therapy regimen and patient/caregiver satisfaction with the therapy was assessed. Pulmonary function, was assessed for each subject at baseline, after 1 month and after 3 months of home therapy. Results from the therapy period was compared to the baseline period, during which the subject received their regular airway clearance regimen. Airway Clearance Satisfaction surveys were conducted at baseline, after 1 month, and after 3 months of therapy. Results from the MN4000 therapy period were compared to the baseline period, during which the subject received their regular regimen
15880952|NCT03797664|Drug|CDX-6114|CDX-6114 will be administered as a single, oral dose solution at dose levels of 7.5, 15.0 and 22.5g
15880953|NCT03797664|Drug|Placebo|Phosphate Buffer Diluent oral solution
15880954|NCT03797651|Drug|Standard DAPT|Patient will continue standard treatment (aspirin plus ticagrelor) for 1 year. Dosage of ticagrelor would be 90 mg twice a day, and 100 mg of aspirin will be prescribed once a day.
15880955|NCT03797651|Drug|Very-short DAPT less than 1 month after PCI|Patient will stop aspirin (ticagrelor monotherapy) after discharge or within 1 month. Dosage of ticagrelor would be 90 mg twice a day, and 100 mg of aspirin will be prescribed once a day (during hospitalization).
15880956|NCT03797638|Device|Finger Force Manipuladum (FFM)|Tasks performed with the device Finger Force Manipuladum (FFM), to assess abilities such as finger individuation but also fine finger force control, finger movement regularity and speed.
15880957|NCT03797625|Drug|Irinotecan|60mg/m2，D1，8
15880958|NCT03797625|Drug|DDP|60mg/m2，D1
15880959|NCT03797625|Drug|Endostar|15mg/d，d1-d7 civ
15880960|NCT03797612|Drug|Brivoligide Injection 660 mg/6 mL|Single preoperative intrathecal injection
15880961|NCT03797612|Drug|Placebo 6 mL|Single preoperative intrathecal injection
15880962|NCT03797599|Behavioral|20 minutes of mindfulness practice|A 20 minute audio guided mindfulness of breathing practice per session, for four sessions.
15880963|NCT03797599|Behavioral|5 minutes of mindfulness practice|A 5 minute audio guided mindfulness of breathing practice per session, for four sessions.
15880964|NCT03797599|Other|5 minute audio book|5 minutes from an audio book by Bill Bryson ('A Short History of Nearly Everything') per session, for four sessions.
15880965|NCT03797599|Other|20 minute audio book|20 minutes from an audio book by Bill Bryson ('A Short History of Nearly Everything'), per session, for four sessions.
15880966|NCT03797599|Other|25 minute audio book|25 minutes from an audio book by Bill Bryson ('A Short History of Nearly Everything'), per session, for four sessions.
15880967|NCT03797586|Other|Electroacupuncture group|Bilateral Tianshu (ST25), Fujie (SP14), Shangjuxu (ST37) will be used in the EA group. With the local skin of the patients was routinely sterilized in a prone position in relaxation, acupuncturists will insert needles into the acupuncture points. For ST25 and SP14, 0.30×50mm or 0.30×75mm needles will be vertically inserted to the muscle layer of the abdominal wall, where participants will feel sharp pain and acupuncturists will feel resistance from the needle tip. For ST37, 0.30×40 mm needles will be vertically inserted approximately 15 mm deep, followed by three-time manipulation of even lifting and twisting method to elicit the sensation of deqi. Then paired alligator clips of the EA apparatus will be attached to the needle holders of the bilateral ST25, SP14, and ST37. EA stimulation will be retained for 30 minutes with a continuous wave of 10 Hz and current intensity of 0.5 to 4 mA.
15880968|NCT03797586|Other|Sham electroacupuncture group|Bilateral sham ST25, SP14, and ST37 will be used in the SA group. After sterilizing the skin, 0.30×40mm needles will be straightly inserted at the sham points about 2-3mm until they can be fixed on the skin when attached by the alligator clips. No manipulation will be used, and no deqi sensation are elicited for all sham points. The bilateral sham ST25, SP14, and ST37 points will be attached by the same EA apparatus with a continuous wave of 10 Hz and current intensity of 0.1 to 0.2 mA for 30 minutes with only the initial 30 seconds on.
15880969|NCT03797573|Device|tDCS|tDCS will be applied during 20 minutes with a current of 1 mA preceded and followed by a behavioral assessments (Modified Ashworth Scale and Coma Recovery Scale Revised) and an EEG. The anodes will be placed over F3 and F4 and the cathodes over C3 and C4.
15880970|NCT03797573|Device|sham tDCS|Indentical to the active tDCS, except that the stimulation is terminated after 5 seconds.
15880971|NCT03797560|Other|Ba-Duan-Jin|"Ba-Duan-Jin is a common form of self-health-care Qigong exercise that has been practiced by Chinese people for at least eight hundred years. It consists of eight sets of simple movements. By combining meditation with slow, graceful movements, deep breathing, and relaxation, Ba-Duan-Jin practitioners believe it has the ability to move vital energy (Qi) throughout the body. Ba-Duan-Jin is also considered to be a multicomponent intervention that integrates physical, psychosocial, emotional, spiritual, and behavioral elements. While the biological mechanisms remain unclear, previous clinical trials have demonstrated that Ba-Duan-Jin can improve sleep quality, physical health, and mental health in patients with various chronic diseases"
15880978|NCT03797482|Procedure|Intra-operative Tumor Tissue Biopsy|The changing pattern of gene expression during surgery has never been studied. This could be an effect of acute hypoxia that sets in the tumour during surgery or could be a surgical response. To study these changes happening in the tumour during surgery, we are taking serial biopsies during surgery, one at the beginning, one midway during surgery and one at the end of surgery. These samples will be snap frozen and stored at -80 deg celsius in biorepository for future analysis.
15880979|NCT03797469|Dietary Supplement|Vitamin B3|3 tablets of 1000 mg each will be administered orally.
15880980|NCT03797469|Dietary Supplement|Pyruvate|2 tablets of 1500 mg each will be administered orally.
15880981|NCT03797469|Dietary Supplement|Placebo|Tablets will look identical to the supplements and the number of tablets will equal the amount of supplements provided.
15880982|NCT03797456|Drug|ICP-022|ICP-022 (tablets, 50 mg) is given orally at the dose of 150 mg/day from day 1 to day 28 of each cycle for up to a total of 6 cycles or until progression.
15880983|NCT03797443|Drug|Ascorbic Acid|"Four escalating dose levels are planned in order to determine the MTD for Phase II
~The dose level for Phase II patients will be determined following completion of the Phase 1b study based on response from 3-6 patients receiving the designated dose level of ascorbic acid."
15880984|NCT03797443|Drug|nab paclitaxel|30 minute IV infusions on days 1 and 8 repeated every 21 days, followed by Cisplatin
15880985|NCT03797443|Drug|Cisplatin|60minute IV infusion on days 1 and 8 repeated every 21 days followed by Gemcitabine
15880986|NCT03797443|Drug|Gemcitabine|30 minute IV infusion on days 1 and 8 repeated every 21 days
15880987|NCT03797391|Drug|EMB-01|"In part 1, patients will receive intravenous infusions of EMB01 weekly (QW). Dose escalation will continue until the maximum tolerated dose (MTD) or recommended phase II dose (RP2D) is reached or all planned doses are administered.
~In part 2, participants will receive intravenous infusion of EMB-01 at RP2D
~The duration of each treatment cycle in both part 1 and part 2 is 28 days (4 weeks).
~Participants may continue to receive study drug until discontinuation criteria are met."
15880989|NCT03797365|Other|Classical rehabilitation|"Participants will benefit from two-phases perineal rehabilitation:
~First phase will include the PFM's awareness and voluntary contraction learning with manual, biofeedback technics and functional electro stimulation. These exercises will call out the manual rehabilitation technics, biofeedback and electro stimulation. Each classical rehabilitation session will take 30 minutes with 20 minutes of active working, twice per week. About the self-training, there will be no consensus for optimal homemade exercises.
~For the second phase, a behavior analyze will be summarized in order to update the favoring and inappropriate situations. The strategy put in place will be organized in unlearning of deleterious perineal habits and learning new behavior program. The main goal will be the perineal locking set up, which must be systematic before and during efforts. During this phase, the physiotherapist will twice weekly perform evaluations (similar to those in the first phase)"
15880990|NCT03797365|Behavioral|Cognitive associated rehabilitation|The cognitive associated rehabilitation group randomized participants will have to execute twice a day the rehabilitation protocol. Each cognitive rehabilitation session will take three minutes. Participants will have to synergistically execute attentional tests (N-Back Test) and execute a perineal contraction during the contraction instructions. (10 randomized auditory stimuli in three minutes). The attentional tests' difficulty will be gradually increased each 15 days. N-Back Test modalities are the followings: the participant will visualize a series of random numbers. First difficulty step will be to click the dedicated button when the volunteer will see the indicated letter. The second difficulty step will be to click the dedicated button when she will see two consecutives times the same letter. The third difficulty step will be to click the dedicated button when she will see two times the same letter separated by one different letter, and so on…
15880991|NCT03797352|Other|Multicomponent exercise|To identify frailty and other potential health issues, and determine if Multicomponent exercise helps at-risk elderly to have better health outcomes.
15880992|NCT03797339|Other|risk factors of adverse cardiovascular events|During the follow-up period,general information(age, sex, BMI, blood pressure, the history of drink and smoke, medical history, etc).Blood biochemistry parameters（Lipid, hsCRP levels, etc）and other laboratory examination parameters will be collected
15880993|NCT03797339|Other|multi-omics target discovery|Genome-wide genotype , DNA methylation and metabolomes were determined using illumina high-density genotyping chips, high-throughput sequencing, and high-resolution mass spectrometry respectly. Blood exposure of statins and metoprolol and its metabolites was determined by UPLC-MS/MS.
15880994|NCT03797339|Other|validation|The genome-wide genotype of patients with coronary heart disease was detected using the illumina chip. The methylation level of the functional region was detected by the target region enrichment methylation sequencing method. Intestinal flora differences were detected using 16SrDNA high-throughput sequencing.
15880995|NCT03797339|Other|Predictive mathematical models|Machine learning algorithms such as multiple linear regression or Bayesian classification are used to optimize clinical factors and multi-group targets to establish predictive mathematical models.
15880998|NCT03797300|Device|Spry Loop Band|Loop band measures pulse oximetry and respiration rate
15880999|NCT03797287|Device|Tensor Tunnler|Create the bone tunnels during the arthroscopic rotator cuff repair procedure
15881000|NCT03797287|Procedure|Anchor Rotator Cuff Repair|The suture anchors (Smith and Nephew PEEK Helicoil Anchor) are inserted in bone and the sutures are then used to sew the tendons to bone arthroscopically.
15881003|NCT03797248|Combination Product|Chinese herbal medicine|All Chinese herbal products prescribed from TCM physicians in our hospital during patients receiving adjuvant chemotherapy
15881040|NCT03796923|Other|Possible follow-up visit from GP|Usual care: follow up visit from GP within one week after discharge
15881004|NCT03797235|Procedure|Dominant Arm|The volume of local anesthetic used for the block of the ulnar and median nerve will be 5 times the estimated 95% effective dose (ED 95 ) of LA needed to block the nerve relative to the nerve cross-sectional area. The ED 95 for the ulnar nerve has been elucidated to be 0,11ml/mm2. The same ED 95 will be used for the median nerve.
15881005|NCT03797235|Procedure|Non-dominant arm|The volume of local anesthetic used for the block of the ulnar and median nerve will be 5 times the estimated 95% effective dose (ED 95 ) of LA needed to block the nerve relative to the nerve cross-sectional area. The ED 95 for the ulnar nerve has been elucidated to be 0,11ml/mm2. The same ED 95 will be used for the median nerve.
15881006|NCT03797222|Dietary Supplement|Vitamin E|Subjects will take an oral Vitamin E (alpha-tocopherol) supplement once daily with a fat-containing meal for 2 weeks. The dose will be based on subject age (150 IU if 1-3 years old, 300 IU if 4-8 years old, 450 IU if 9-17 years old, 600 IU if >17 years old). Formulations include 50 IU/mL liquid and 200 IU capsules. The liquid formulation will be used for subjects who will receive <600 IU daily, or for any subjects who prefer liquid medication to capsules.
15881007|NCT03797209|Device|EUS-guided fistulization AXIOS|By using a convex type ultrasonic endoscope to form a fistula by gastrointestinal puncture, to perform various drainage.
15881008|NCT03797196|Drug|low dose tacrolimus in combination with everolimus|a low exposure Tacrolimus once-daily (Envarsus®) regimen in combination with Everolimus will be evaluated in elderly transplant recipients
15881009|NCT03797196|Drug|standard dose tacrolimus with mycophenolate mofetil|A standard Tacrolimus once-daily (Envarsus) regimen in combination with Everolimus will be evaluated in elderly transplant recipients
15881010|NCT03797170|Other|Gut microbiota samples|Gut microbiota analysis from diagnosis to follow up after first line-chemo-immuntherapy
15881011|NCT03797157|Dietary Supplement|H2MF|H2MF is a human milk-based breastmilk fortifier for preterm infants
15881012|NCT03797157|Dietary Supplement|Bovine milk-based fortifier|Bovine milk-based fortifier is the standard breast milk fortifier in Sweden
15881013|NCT03797144|Device|CD HORIZON® Fenestrated Screw System with Fenestrated Screw Cement|The CD HORIZON® Legacy™ and Solera™ Fenestrated Screw Spinal System consists of a variety of cannulated screws with a series of fenestrations to allow polymethylmethacrylate (PMMA) bone cement (Fenestrated Screw Cement) to be injected into the treated site. The Fenestrated Screw Cement is used to augment screw fixation in subjects with compromised bone quality.
15881014|NCT03797131|Other|KB195 (a novel mixture of oligosaccharides)|KB195 (a novel mixture of oligosaccharides) for oral intake for 21 days.
15881015|NCT03797118|Device|FFR|Fractional flow reserve measured during cardiac catheterization
15881016|NCT03797105|Behavioral|School-Based Obesity Intervention (FLOW)|The intervention consisted of nutrition lessons based on the traffic light diet, circuit-based physical activity, behavior modification techniques (token economy system, goal setting, self-monitoring), and parental involvement (materials sent home and monthly parent meetings). 80% of time was spent on physical activity and 20% was spent on nutrition. Behavior modification was incorporated into both physical activity and nutrition time. Specifically, instruction and activity time during PE class lasted approximately 40 minutes.
15881017|NCT03797092|Biological|Allogeneic adipose-derived stromal cells (CSCC_ASC)|Active group
15881018|NCT03797092|Other|Control group|No treatment
15881019|NCT03797079|Procedure|ESP block|A high-frequency linear ultrasound probe will be placed superficial to erector spinae muscle (ESM) in a parasagittal plane 3 cm lateral to the midline at the level of fifth thoracic vertebra. Three muscles will be identified superficial to the hyperechoic transverse process shadow: trapezius (uppermost), rhomboids major (middle), and ESM (lowermost). After local infiltration of skin and using in-plane approach, an 18 G Tuohy needle will be inserted, until the tip lay between the rhomboid major muscle and ESM.
15881020|NCT03797079|Procedure|TEA|Skin will be locally infiltrated at the site of needle insertion, and 18 G Tuohy needle will be introduced until its tip lay in the epidural space of the T5-T6 thoracic intervertebral space.
15881021|NCT03797079|Device|Catheter insertion|After obtaining loss of resistance, 20 G epidural catheter will be threaded for 5 cm and then fixed on the skin.
15881022|NCT03797079|Drug|Bupivacaine|After the negative aspiration for blood, a bolus dose of 15 ml 0.125% plain bupivacaine will be injected in the catheter, followed by a continuous infusion of 0.25% plain bupivacaine at the rate of 0.1 ml/kg/h for 48 hours
15881023|NCT03797066|Drug|ZEPATIER 50Mg-100Mg Tablet|Zepatier 50/100 OD , with addition of Ribavarin in patients with Genotype 1a and 4 with HCV RNA> 800,000 iu/ml or baseline NS5A resistance.
15881024|NCT03797053|Procedure|Biological sample|"Biological sample performed :
~before treatment
~1 months after the beginning of treatment
~every tumoral assessment"
15881025|NCT03797040|Biological|Cell therapy|PLX-R18: Allogeneic ex vivo expanded placental stromal cells
15881026|NCT03797027|Device|Percutaneous Nephrolithotomy without an abdominal cushion|patients undergo prone PNCL without an abdominal cushion
15881027|NCT03797027|Device|Percutaneous Nephrolithotomy with an 5 cm abdominal cushion|patients undergo prone PNCL with an 5 cm abdominal cushion
15881028|NCT03797027|Device|Percutaneous Nephrolithotomy with an 5 cm abdominal cushion|patients undergo prone PNCL with an 10 cm abdominal cushion
15881029|NCT03797014|Drug|B/F/TAF|Fixed dose combination B/F/TAF (50 mg/ 200 mg/ 25 mg/ tablet) administered orally once daily without regards to food.
15881030|NCT03797001|Drug|Anakinra|100 mg subcutaneous injection, daily for 24 weeks
15881031|NCT03797001|Drug|Placebo|subcutaneous injection, daily for 24 weeks
15881032|NCT03796988|Device|Autologous Regeneration of Tissue (ART) device|This device will harvest hundreds of full-thickness columns of skin tissue (500 micrometer diameter) using single-needle, fluid-assisted harvesting technology.
15881033|NCT03796975|Drug|Combination of Pioglitazone and Metformin Tablets|15mg/500mg, oral, 2/day
15881034|NCT03796975|Drug|Metformin Hydrochloride Tablets|Oral metformin 850mg, 2/day in the control group
15881035|NCT03796962|Drug|XEN1101|Oral dose
15881036|NCT03796936|Behavioral|Motion-assisted, Multi-modular Memory Desensitization and Reconsolidation (3MDR) Therapy|a novel treatment for PTSD combining aspects of virtual reality exposure therapy (VRET) and Eye Movement Desensitization and Reprocessing (EMDR), within the Computer Assisted Rehabilitation Environment (CAREN)
15881037|NCT03796923|Other|Early follow-up visit after discharge|Early follow-up visit and different degrees of specialized care after discharge
15890019|NCT03727100|Other|Sham|Injection
15881041|NCT03796910|Drug|SPR720 for SAD|Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 8 dose ascending cohorts) to receive either SPR720 or placebo. The study drug (SPR720 or placebo) will be administered as a single dose.
15881042|NCT03796910|Drug|Placebo for SAD|Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 8 dose ascending cohorts) to receive either SPR720 or placebo. The study drug (SPR720 or placebo) will be administered orally as a single dose.
15881043|NCT03796910|Drug|SPR720 for MAD|Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 3 cohorts) to receive either SPR720 or placebo. The study drug (SPR720 or placebo) will be administered orally for a total of 7 (or 14) days of dosing.
15881044|NCT03796910|Drug|Placebo for MAD|Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 3 cohorts) to receive either SPR720 or placebo. The study drug (SPR720 or placebo) will be administered orally for a total of 7 (or 14) days of dosing
15881045|NCT03796897|Dietary Supplement|Leucine-enriched protein|Supplement contains 16g of protein given twice per exercise session (4 total exercise sessions)
15881046|NCT03796897|Behavioral|Habitual diet only|Habitual diet only (no supplementation) for 4 exercise sessions
15881047|NCT03796884|Drug|Linaclotide|Given PO
15881048|NCT03796884|Other|Placebo|Given PO
15881049|NCT03796871|Device|Dermapol|Use of the experimental medical device before lesion excision : skin lesion lighting (4 wavelengths) for less than 1 minute and image recording
15881050|NCT03796858|Drug|Guselkumab 100 mg|Participants will receive guselkumab 100mg as SC injection.
15881051|NCT03796858|Drug|Placebo|Participants will receive placebo as SC injection.
15881052|NCT03796845|Other|No limited movement after surgery|Participants should move their arms from the first postoperative day, with unrestricted movement, with an amplitude above 90º for flexion and abduction of shoulder.
15881053|NCT03796832|Device|Flat Flexible Shoes|Off-the-shelf commercially available shoes will be used compliant with previously published criteria: (i) heel height <15 mm, (ii) shoe pitch <10 mm, (iii) absent arch support/motion control, (iv) minimal sole rigidity, (v) weight <=200g (+/-10%). Participants will be instructed to wear the shoes at least 4 hours daily for the duration of the 9-month intervention and to avoid wearing other types of shoes, if possible.
15881054|NCT03796832|Device|Stable Supportive Shoes|Off-the-shelf commercially available shoes will be used compliant with previously published criteria: (i) heel height >30 mm, (ii) shoe pitch >10 mm, (iii) present arch support/motion control, (iv) sole rigidity, (v) weight >300g (+/-10%). Participants will be instructed to wear the shoes at least 4 hours daily for the duration of the 9-month intervention and to avoid wearing other types of shoes, if possible.
15881055|NCT03796832|Other|Exercise Therapy|The 3-month supervised exercise program will consist of one group session per week of approximately 30 minutes complemented with home-based exercises 3 times per week. Group sessions will consist of a 10-min warm-up followed by a circuit training of strengthening and/or neuromuscular exercises. Subsequently, during a 6-month unsupervised home exercise program, participants will perform strengthening exercises of the lower limb muscles 3 times weekly. Throughout the 9-month intervention, participants will be encouraged to maintain a daily routine of aerobic exercises, consisting of structured activity bouts of at least 10 minutes at a moderate intensity (grade 5-6 (out of 10, maximum exertion) on a Rate of Perceived Exertion scale), achieving at least 70 minutes of weekly physical activity at 3 months and 150 minutes at 9 months.
15881056|NCT03796819|Procedure|lymphadenectomy|Patients would undergo routine hepatoduodenal lymphadenectomy at the time of ICC resection
15881057|NCT03796793|Procedure|Wound Edge Debridement|Wound debridement is performed using a sharp, circular disposable curette to remove the slough, non-viable tissue and any fibrous tissue down to the vascular base.
15881058|NCT03796793|Other|Standard of Care Treatment|Standard of Care treatment will include foam dressing and 4 layer compression therapy, changed weekly.
15881059|NCT03796780|Dietary Supplement|Extra-Virgin Olive Oil|Daily consumption of 25 mL Extra-Virgin Olive Oil in adjunct to medical treatment for 6 weeks
15881060|NCT03796780|Dietary Supplement|Refined Olive Oil|Daily consumption of 25 mL Refined Olive Oil in adjunct to medical treatment for 6 weeks
15881061|NCT03796767|Radiation|Hypofractionated Radiation Therapy|Undergo hypofractionated radiation therapy
15881062|NCT03796767|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
15881063|NCT03796767|Procedure|Metastasectomy|Undergo salvage oligometastasectomy
15881064|NCT03796767|Other|Quality-of-Life Assessment|Ancillary studies
15881065|NCT03796767|Other|Questionnaire Administration|Ancillary studies
15881066|NCT03796767|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15881067|NCT03796754|Behavioral|YoBEKA|The teachers and students of the YoBEKA study arm receive a guided YoBEKA practice from an experienced YoBEKA trainer during the regular 4 month intervention period. The YoBEKA program is based on a combination of different, easy to perform exercises appropriate to the school situation, consisting of postures, verses for speech, song and movement, affirmations in movement to promote balance and coordination, and various rest and silence exercises to promote body awareness and relaxation techniques. The teaching is ideologically neutral and without religious background. The participating teachers receive an initial two-hour YoBEKA introductory course. Every 2 weeks there is a one to two-hour training course. The pedagogical specialists are supported once a week by an experienced YoBEKA trainer. The teachers are encouraged to integrate the learned exercises independently and regularly into their everyday school life.
15881068|NCT03796741|Other|Data collection on Stable Ischemic heart disease|No intervention only description of management and treatment
15881069|NCT03796728|Device|Juvéderm® VOLIFT™ with Lidocaine|Injectable gel that is a sterile, biodegradable, non-pyrogenic, viscoelastic, clear, colorless, homogeneous gel implant (dermal filler).
15881070|NCT03796715|Diagnostic Test|Red Cell Distribution Width (RDW)|A total of 100 sepsis patients, Red Cell Distribution Width (RDW) was used as prognostic marker.
15881071|NCT03796715|Diagnostic Test|Presepsin (sCD14-ST)|: A total of 100 sepsis patients, Presepsin (sCD14-ST) was used as prognostic marker.
15881072|NCT03796702|Procedure|Deileostomy|Deileostomy
15881100|NCT03796468|Procedure|Mechanical Thrombectomy|MT in the Experimental Arm can be performed with any thrombectomy (CE labeled) device usually used at study site. For the subjects randomized to the MT plus medical, the MT is performed immediately after the randomization
15881075|NCT03796676|Drug|Placebo|Placebo
15881076|NCT03796676|Drug|PF-04965842|100 mg QD
15881077|NCT03796676|Drug|PF04965842|200 mg QD
15881078|NCT03796663|Behavioral|Mindful Parenting Program|"The Mindful Parenting Program consists of 7, 2.5 hour weekly group sessions. In the program, parents learn to apply the skills of mindfulness to themselves and to their experience of parenting their children. Parents are introduced to formal meditation practices, including the bodyscan; choiceless awareness; mindful walking; and yoga. They are also introduced to mindfulness of everyday activities from the beginning of the sessions, with an added focus on day-to-day parenting and family activities. Additionally, short self-compassion practices occur throughout the weekly sessions, culminating in the teaching of formal loving-kindness meditation.
~Additionally, the program encourages parents to engage in home practice, where parents can experience and practice many of the new skills they are learning. This includes both formal, longer meditation practices, as well as shorter practices, which can occur throughout the day, such as mindfulness of daily routines."
15881079|NCT03796663|Behavioral|MATCH BPT Program|The MATCH BPT Program consists of 8-12 weekly (depending on how long it takes for individual parents and their assigned trainer to get through the material), 60 minute individually-implemented sessions.The sessions will consist of the coach obtaining and reviewing weekly assignments completed by the parent, followed by activities and discussions that focus on a particular parenting skill (i.e. praise, active ignoring, giving effective instructions). The discussions will emphasize benefits and possible problems that the parent may encounter throughout the week while implementing the new skill. The coach will assign to the parent a practice assignment to further encourage use of the concept.
15881080|NCT03796650|Other|Fecal microbiota transplantation|50 g donor feces suspended in saline with added glycerol, administered by a enema kit.
15881081|NCT03796650|Drug|Vancomycin|Peroral vancomycin 125 mg q.i.d. for ten days.
15881082|NCT03796637|Other|Dystrophin levels|Dystrophin levels of participants who have previously received at least 9 months of treatment with ataluren.
15881083|NCT03796637|Drug|Ataluren|Ataluren will be administered as per the dose and schedule specified in the arm.
15881084|NCT03796624|Device|Micropure 1.2.3.|"Implantation of intraocular lens (IOL). Name: MicroPure 1.2.3. It is a monofocal intraocular lens consisting of hydrophobic acrylic material. One IOL per patient will be implanted"
15881085|NCT03796624|Device|PODEYE|"Implantation of intraocular lens (IOL). Name: PODEYE It is a monofocal intraocular lens consisting of hydrophobic acrylic material. The IOL will be implanted in the contralateral eye of the same patient already implanted with Micropure 1.2.3."
15881086|NCT03796598|Drug|Fecal Microbial transplant Capsules|Oral capsules of FMT
15881087|NCT03796598|Drug|Fecal Microbial Transplant Enema|FMT enema
15881088|NCT03796598|Other|Placebo|Placebo
15881089|NCT03796585|Behavioral|Immunization Registry Training|Education highlighting practical strategies to improve pharmacies' willingness to adopt the immunization registry and improve their ability to integrate the immunization registry into their pharmacy workflow.
15881090|NCT03796585|Behavioral|Informational flyer|Informational flyer with ImmPRINT contact information
15881091|NCT03796572|Drug|Ropivacaine|Regional anesthesia protocol of open reduction percutaneous pinning of lateral condyle humerus fracture Ropivacaine
15881092|NCT03796572|Other|Puncture Wound and Dressing|No regional anesthesia is given for open reduction percutaneous pinning of lateral condyle humerus fracture
15881093|NCT03796559|Device|Magseed Marker|Implantable Magseed marker for marking lesions in soft tissue, detected using the Sentimag handheld probe.
15881094|NCT03796533|Drug|Posaconazole|"PCZ will be used as recommended in tablet formulation at an initial dosage of 300 mg twice a day on the first day and then once a day at a dose of 300 mg the following days.
~PCZ prophylaxis will be started on the same day as the start of chemotherapy and will be continued until the end of aplasia.
~The dosage of the PCZ can be adjusted according to the results of the PCZ assay. It may be interrupted if the transaminase level is greater than 3 times higher than normal (3N) or on medical decision."
15881095|NCT03796520|Diagnostic Test|EpiPick simplified seizure classification algorithm|"EpiPick simplified seizure classification algorithm input:
~Grey matter brain lesion Exclusively nocturnal seizures First seizure at age > 20 years Lip smacking or chewing during seizures Staring with impaired awareness, lasting less than 20s without postictal confusion Sudden irregular jerks, in isolation or brief series, if none of the following applies: Are the jerks consistently in the same limb? When resting in bed when falling asleep? Bilateral tonic-clonic seizures within 1h of awakening or immediately preceded by irregular jerks Any of the following is present: Skin turning pale pre-ictally; Loss of consciousness immediately after urination or defecation; Sudden slump with loss of awareness, lasting less than 10 seconds; Seizure lasting longer than 10 minutes, with eyes closed throughout the seizure; Severe pre-ictal headache; Episodes consisting of falls that occur always after change in posture to the upright position, or coughing or feeling pain."
15881096|NCT03796507|Drug|Temozolomide|oral temozolomide at 75 mg per square meter of body surface area daily for 21 days
15881097|NCT03796494|Procedure|Straight abutment|This is the classic abutment, straight and anti-rotational for dental implants which have been tested before
15881098|NCT03796494|Procedure|Slim abutment|This is the new concept of the prostheses abutment, slim and anti-rotational to improve the width of biologic space
15881099|NCT03796468|Other|Best Medical Therapy|The administration of medications is at the treating physician's discretion (for example intravenous fibrinolysis, anticoagulants or antiplatelet) according to local standards of care but may NOT include any intra-arterial therapies. The rescue MT may be performed in case of deterioration within the 24 hours
15890025|NCT03727061|Drug|Porfimer Sodium|Given IV
15881101|NCT03796455|Dietary Supplement|Capsule + Powder supplementation|For Fish oil and Placebo oil, treatment will be provided in capsules.Each group will receive dose distributed to 3 capsules per day. Participants will be instructed to take all capsules with morning meal. . For HMB and a placebo powder, product will be delivered as powder taken with water or non-carbonated beverage (like juice). Product will be provided in 2 sachets/day. One sachet should be consumed with breakfast and the other prior to bedtime (approx. 10pm).
15881102|NCT03796455|Other|stable tracer infusion|labeled amino acids L-Phenylalanine (ring-13C6), L-Tyrosine (ring-D4), and tau-Methylhistidine will be infused as a single injection. Subsequently, the catheter will be used for arterialized venous blood samples (3 ml) drawn multiple through the day
15881103|NCT03796442|Device|AVR with AVALUS|aortic valve replacement with AVALUS bioprosthesis
15881104|NCT03796442|Device|AVR with CEPME|aortic valve replacement with Carpentier-Edwards Perimount Magna Ease bioprosthesis
15881105|NCT03796429|Drug|GS+Toripalimab|"Patients will be given treatment as below once recruited: PD-1 antibody Toripalimab（240mg, iv, q3w），combined with GS regimen(gemcitabine 1000mg／m2 ，d1,d8 + S1 40-60mg bid*14d，Q21d).
~The treatment will be continued until emerging of disease progression or intolerable adverse effects (The upper time limit for treatment is 2 years)."
15881106|NCT03796416|Drug|Misoprostol|used at a rate of 25 mcg Q4hours for cervical ripening.
15881107|NCT03796403|Other|Diclofenac|Twenty mL of bupivacaine was infiltrated into surgical-site peritoneum , divided in 10 sites before closure, and diclofenac 75 mg (3 mL) was intramuscularly injected immediately after complete the procedure and the operative field was covered with sterile adhesive wound dressing.
15881108|NCT03796390|Biological|CD123 CAR-T cells|Patients will be drawn 50-100 ml blood to obtain enough peripheral blood mononuclear cells (PBMC) for CAR-T manufacturing. The T cells will be purified from the PBMC, transduced with CAR lentiviral vector, expanded in vitro and then frozen for future administration. Chemotherapy will then be given. Following tumor burden reassessment, CD123 CAR-T cells will be infused.
15881109|NCT03796377|Drug|St Johns Wort Extract|20 mg rivaroxaban after supplementation with St. John's wort extract (Jarsin®) twice daily 450 mg po for 2 weeks.
15881110|NCT03796377|Drug|Rivaroxaban|20 mg rivaroxaban.
15881111|NCT03796364|Drug|Endostar|Patients in the observation group were treated with routine radiation pneumonia and Endostar. Endostar usage: continuous intravenous pumping of Endostar(14 doses each time) over 5 days. At week 2, 4, 6, 12, 24, 36, 52, lung functional and blood oxygen saturation was measured, chest CT and the St. George Respiratory Questionnaire (SGRQ) were assessed for quality of life at week 12, 24, 52 and before treatment; collecting the related observation indexes of patients; primary endpoint; recrudescence rate of RP; secondary endpoints; remission rate of RP and incidence rate of RF; incidence rate of RF; number of acute exacerbations and quality of life.
15881112|NCT03796364|Drug|standard SRILI treatment|Patients in the control group were treated with current routine radiation pneumonia. At week 2, 4, 6, 12, 24, 36, 52, lung functional and blood oxygen saturation was measured, chest CT and the St. George Respiratory Questionnaire (SGRQ) were assessed for quality of life at week 12, 24, 52 and before treatment; collecting the related observation indexes of patients; primary endpoint; recrudescence rate of RP; secondary endpoints; remission rate of RP and incidence rate of RF; incidence rate of RF; number of acute exacerbations and quality of life.
15881113|NCT03796351|Drug|MT10107|"Subjects will be administered a single equivalent dose of MT10107 and Botox® by intramuscular injection to the EDB muscles of contralateral feet. Five cohorts of eligible subjects will be studied; Group A (2 U dose), Group B (5 U dose), Group C (10 U dose), Group D (20 U dose) and Group E (30 U dose).
~The foot in which each drug is to be administered (i.e. left or right) will be assigned in a randomized manner."
15881114|NCT03796351|Drug|Botox|"Subjects will be administered a single equivalent dose of MT10107 and Botox® by intramuscular injection to the EDB muscles of contralateral feet. Five cohorts of eligible subjects will be studied; Group A (2 U dose), Group B (5 U dose), Group C (10 U dose), Group D (20 U dose) and Group E (30 U dose).
~The foot in which each drug is to be administered (i.e. left or right) will be assigned in a randomized manner."
15881115|NCT03796338|Device|Sleep Profiler|Patients are observed through a Sleep profiler, routinely used in the intensive care unit (ICU). This device is applied at every patient in the ICU and it acquires EEG, electrooculography, and electromyography from three frontopolar EEG signals.
15881116|NCT03796312|Behavioral|Tub Bathing|The infant's face was washed and dried while still wrapped before being immersed. The water level in the tub was set at approximately 9-12 cm or deep enough to cover the baby's shoulders. A folded cloth towel was placed into the tub before bathing. The temperature of the bath water was controlled using a special water thermometer and adjusted to 37-38°C. The infant was held securely; the head and neck were supported on the researcher's forearm, and the shoulder was grasped using the researcher's thumb and finger. Cleaning was performed using a soft cloth and baby skin cleaner. The front and back areas were cleaned without turning the infant. The newborn was safely removed from the water and wrapped in a clean towel.
15881117|NCT03796312|Behavioral|Sponge Bathing|Sponge bathing is routine care of the clinic
15881118|NCT03796299|Diagnostic Test|Assessment of expression of MCM5 in the urine (ADX Bladder)|Each participant will be asked to urinate in a plastic container. Urine will be centrifuged afterwards, then the expression of MCM5 protein will be examined in cells from urine sediment. For this purpose, it is planned to use the Arquer Diagnostics ADXBLADDER test. It is an enzyme linked immunosorbent assay (ELISA) using two monoclonal antibodies directed against two different epitopes. Both antibodies have high affinity and specificity for the MCM5 antigen.
15881119|NCT03796286|Other|Medium-fiber bar|Each subject will receive one control and two active treatments in a crossover design. The two active treatments are dietary fiber-containing bars at two doses of fiber. The control bar will not contain fiber.
15881120|NCT03796286|Other|High-fiber bar|Each subject will receive one control and two active treatments in a crossover design. The two active treatments are dietary fiber-containing bars at two doses of fiber. The control bar will not contain fiber.
15881121|NCT03796286|Other|Control bar (0 g fiber)|Each subject will receive one control and two active treatments in a crossover design. The two active treatments are dietary fiber-containing bars at two doses of fiber. The control bar will not contain fiber.
15881122|NCT03796273|Other|Best Practice|Undergo standard surgery
15881123|NCT03796273|Drug|Ketoconazole|Given PO
15881124|NCT03796260|Drug|Entrectinib Test Formulation (F1)|Participants will receive a single oral dose of entrectinib F1 after completion of a standardized meal.
15881125|NCT03796260|Drug|Entrectinib Reference Formulation (F06)|Participants will receive a single oral dose of entrectinib F06 after completion of a standardized meal.
15881126|NCT03796234|Other|Dietary and physiotherapy|3 group talks were carried out, in a period of 3 months, in which different topics related to healthy eating were treated. In addition, a 3-month high intensity interval training program was developed. Physiotherapy sessions were carried out twice a week for one hour and intensity was established based in effort tests.
15881127|NCT03796234|Other|Physiotherapy|A 3-month high intensity interval training program was developed. Physiotherapy sessions were carried out twice a week for one hour and intensity was established based in effort tests.
15881128|NCT03796221|Behavioral|Parenting videos|Brief online videos, featuring families of children with obesity of diverse backgrounds, to provide education on parenting skills and motivate families to adopt healthy lifestyle behaviors as a family. Videos will be delivered monthly for three months in between pediatric obesity clinic visits.
15881129|NCT03796221|Behavioral|Standard pediatric obesity treatment|Standard treatment in a hospital-based pediatric obesity clinic with a team of medical providers, dietitians, exercise specialists, and behavioral health specialists. Treatment includes management of obesity-related medical conditions, nutrition education, physical activity counseling, and discussion of behavioral strategies such as goal-setting and self-monitoring, with elements of motivational interviewing used to encourage behavior change and adoption of healthy lifestyle behaviors by the entire family.
15881130|NCT03796208|Behavioral|Behavioral and Enhanced Perinatal Intervention for Cessation (B-EPIC)|Women enrolled in the intervention group will receive TAU plus B-EPIC, which includes four core components: 1) Individualized tobacco treatment plus supplemental counseling, 2) Biomarker validation and feedback, 3) Change in maternal thought process and adoption of healthy behavior (e.g. exercise, based on PI framework), and 4) Pharmacotherapy as needed (see Table 3 for a summary of the study design). The initial assessment for this intervention takes 60 minutes, with follow-up sessions typically lasting 15-20 minutes. All sessions occur prior to or after pre-scheduled perinatal appointments. The intervention will be led by a certified tobacco treatment specialist (CTTS).
15881131|NCT03796208|Behavioral|Treatment As Usual|Women enrolled in the control group are informed of the risks of tobacco use and benefits of quitting using the ACOG 5'A's approach by their healthcare provider. This standard takes approximately 5-15 minutes, and is offered at each prenatal and postpartum appointment. The five steps of the ACOG recommendation are: 1.) Ask about tobacco use, 2.) Advise to quit, 3.) Assess willingness to make a quit attempt, 4.) Assist in quit attempt, and 5.) Arrange follow-up. The provider may also talk to the participant about nicotine replacement therapy.
15881132|NCT03796195|Drug|.5% Bupivacaine|Ultrasound guided right sided stelate ganglion block using .5% bupivacaine (5mLs)
15881133|NCT03796182|Drug|Metformin|Commercially available metformin (GLUCOPHAGE®) as 500 mg tablets.
15881134|NCT03796182|Drug|PF-04965842|PF 04965842 100 mg tablets
15881135|NCT03796169|Behavioral|Personal notification|Baseline quality indicators of each endoscopist were measured and those were notified individually.
15881136|NCT03796169|Behavioral|Open notification|Quality indicators were measured for 3 months after 1st interventions and those were notified openly
15881137|NCT03796169|Behavioral|Education|Quality indicators were measured for 3 months after 2nd interventions and educated the importance of colonoscopy quality by a GI faculty
15881138|NCT03796156|Drug|Aspirin|75mg low dose non enteric coated
15881139|NCT03796143|Behavioral|The Mindfulness and Acceptance Workbook for Depression|Participants assigned to this condition will be asked to read this self-help book over an 8-week period.
15881140|NCT03796143|Behavioral|The Cognitive Behavioral Workbook for Depression|Participants assigned to this condition will be asked to read this self-help book over an 8-week period.
15881141|NCT03796130|Procedure|Myomectomy|"This study will include women who have intramural myomas ranging from 3-5 cm
~The participants will be randomly allocated into two groups.
~In group (1): myomectomy will be performed before ART
~In group (2):women will have their trial of ART without myomectomy
~In group A, ART will be performed 3 months after myomectomy if the uterine cavity is not opened and 6 months after myomectomy upon inadvertent opening of the uterine cavity during surgery"
15881142|NCT03796117|Device|Pulsed current|"For stage 1 of the study, which corresponds to analysis of the evoked torque, evaluation of the discomfort level, current intensity, analysis of neuromuscular efficiency and clinical efficiency, 2 configurations (PC1 and PC2) will be used.
~PC1, will be set at a frequency of 100 Hz, phase duration of 1000 microseconds, ON-OFF time of 5s:10s.
~PC2, will be set at a frequency of 100 Hz, phase duration of 200 microseconds ON-OFF time of 5s:10s.
~For stage 2 of the study, which corresponds to the analysis of the fatigability level, only the PC1 configuration will be used."
15881143|NCT03796117|Device|Russian Current|"For stage 1 of the study, which corresponds to analysis of the evoked torque, discomfort level, current intensity, neuromuscular efficiency and clinical efficiency, 2 configurations (RC1 and RC2) will be used.
~RC1, will be set to a frequency of 100 Hz, burst duty cycle of 20%, ON-OFF time of 5s:10s.
~RC2, will be set at a frequency of 100 Hz, burst duty cycle of 50%, ON-OFF time of 5s:10s.
~For stage 2 of the study, which corresponds to the analysis of the fatigability level, only the RC2 configuration will be used."
15881144|NCT03796104|Other|Delta-haemolysin|comparison of groups having infection with S. aureus with and without delta-haemolysin Production
15881145|NCT03796091|Behavioral|Educational Brochure|Participants will read an educational brochure from the National Eating Disorders Association and will receive treatment referral resources.
15881146|NCT03796091|Behavioral|Body Project Traditional|Participants will complete a 1-hour per week group therapy program for 4 weeks consisting of the Body Project Traditional group therapy program (see Stice & Shaw, 2001).
15881147|NCT03796091|Behavioral|Body Project Expanded|Participants will complete a 1-hour per week group therapy program for 4 weeks consisting of the Body Project Expanded group therapy program (see Green et al., 2017).
15881148|NCT03796078|Procedure|Maxillomandibular advancement|Treatment: Mono or Bimaxillary Orthognathic Surgery. The surgery of Reposition of the jaws is carried out under general anesthesia using minimally invasive techniques, the patient is extubated After surgery, antibiotics are prescribed during admission, anti-inflammatories, antiemetics and a local cold mask is applied of closed circuit at 17ºCelsius. The patient is discharged at 24 h.
15881180|NCT03795805|Procedure|total knee arthroplasty|Total knee arhroplasty
15881181|NCT03795805|Procedure|Tourniquet limb cuff|Tourniquet limb cuff and regular anesthesia
15881149|NCT03796078|Procedure|monomaxillary surgery (isolated MaxS)|Monomaxillary surgery (Isolated MaxS): The surgery of Reposition of the maxilla is carried out under general anesthesia using minimally invasive techniques, the patient is extubated After surgery, antibiotics are prescribed during admission, anti-inflammatories, antiemetics and a local cold mask is applied of closed circuit at 17ºCelsius. The patient is discharged at 24 h.
15881150|NCT03796078|Procedure|monomandibullary surgery (MandS)|Monomandibullary surgery (Isolated MandS): The surgery of Reposition of the maxilla is carried out under general anesthesia using minimally invasive techniques, the patient is extubated After surgery, antibiotics are prescribed during admission, anti-inflammatories, antiemetics and a local cold mask is applied of closed circuit at 17ºCelsius. The patient is discharged at 24 h.
15881151|NCT03796065|Behavioral|FSI-R Treatment|The FSI-R involves a series of separate and joint meetings with parents and children to discuss challenges the family has faced and the strengths that helped them make it through past challenging times. Additional psychoeducation on mental health and promoting resilience along with coaching to enhance parenting skills is provided throughout and may be tailored to family needs. The FSI-R provides a shared space for refugee families both to recognize their strengths and to problem-solve in a more collective way on family challenges and shared hopes for the future. The FSI-R is delivered in the home, by a trained interventionist, over the course of 10-modules.
15881152|NCT03796052|Other|Avena Sativa Skincare Regimen|Regimen consisting of 3 topical agents containing Avena Sativa (oat) kernel flour: a body wash (type = cosmetic), a body cream (type = cosmetic), and an anti-itch balm (type = OTC monograph drug with 0.5% Pramoxine HCl)
15881153|NCT03796039|Behavioral|Standing|Standing for an additional 100 minutes per week; 20 minutes Monday-Friday
15881154|NCT03796026|Drug|Seltorexant 40 mg|Seltorexant 40 mg capsules (over-encapsulated tablets) will be administered orally.
15881155|NCT03796026|Drug|Placebo|Matching placebo to seltorexant 40 mg capsules (over-encapsulated tablets) will be administered orally.
15881156|NCT03796013|Drug|Entrectinib Form A|Participants will receive a single oral dose of entrectinib form A under fasted conditions.
15881157|NCT03796013|Drug|Entrectinib Form C|Participants will receive a single oral dose of entrectinib form C under fasted conditions.
15881158|NCT03796000|Procedure|tissue samples, blood and stool sample|Tissue samples from gastroscopy/colonoscopy.
15881159|NCT03795987|Device|NightWare Therapeutic System|A wearable digital therapeutic system that will measure physiologic data when worn during sleep to deliver a mild vibration via the watch to elicit arousal thereby disrupting nightmares. This detection and stimulation sequence will be performed according to NightWare's proprietary algorithm.
15881160|NCT03795974|Biological|MNC|Hematopoietic stem cells derived from allogenic umbilical cord
15881161|NCT03795974|Biological|MSC|Mesenchymal cells derived from allogenic umbilical cord
15881162|NCT03795974|Procedure|Control|control group without injection and appearance simulating lumbar puncture without awareness of the patients and evaluators , but rehabilitation continued .
15881163|NCT03795961|Device|transcranial direct current electrical stimulation|anodal tDCS of M1 for 20 minutes, at 2 mA for 5 sessions (day after day)
15881164|NCT03795948|Other|PROMs|"Introduction and assessment of the ICHOM standard set consisting of demographic and medical data as well as questionnaires filled in by patients, shortly after admission to the stroke unit, at discharge, and at 90 and 360 days after stroke.
~Specifically the intervention includes an assembly of clinical records, in particular records of complications, recurrence of disease and mortality. Further patients will be required to complete a questionnaire assessing their situation in terms of housing and symptom burden as well as their self-perceived autonomy and quality of life.
~Telephone assessments will be administered to support patients if necessary and validate their responses."
15881165|NCT03795935|Other|No side-effect stimulator settings with directional lead|Individuals in this arm will have their stimulator settings programmed to the point in which they have maximum tremor control with no side effects.
15881166|NCT03795922|Drug|MT10109L|MT10109L will be injected into the GL.
15881167|NCT03795922|Drug|Placebo|Placebo will be injected into the GL.
15881168|NCT03795909|Drug|Ruxolitinib|Ruxolitinib （2.5 mg twice daily for patients if the age<14 years and the weight <25kg，5 mg twice daily for patients if the age<14 years and the weight≥25kg, 10mg twice daily for patients if the age ≥14 years and<18 years）
15881169|NCT03795909|Drug|Dexamethasone|Dexamethasone (10mg/m2.d) delayes for the first 2 weeks（form week 1 to 2),(5mg/m2.d) from week 3 to 4，(2.5mg/m2.d) from week 5 to 6），1.25mg/m2.d for week 7，and dropped off on week 8.
15881170|NCT03795896|Diagnostic Test|Optic nerve sheath diameter|The intracranial pressure will be measured by the optic nerve sheath diameter and after giving the mannitol osmotherapy the intracranial pressure will be monitored by the optic nerve sheath diameter
15881171|NCT03795870|Dietary Supplement|Polymeric Tube Feeds|Polymeric tube feeds will be given to HEN patients to assess the percentage of goal calories provided in comparison with blenderized tube feeds
15881172|NCT03795870|Dietary Supplement|Blenderized Tube Feeds|Blenderized tube feeds will be given to HEN patients to assess the percentage of goal calories provided in comparison with polymeric tube feeds
15881173|NCT03795857|Behavioral|Semi-structured interviews|The purpose of this study is to describe the experience of pregnancy by parents who have chosen to carry to term despite a lethal fetal diagnosis. Therefore, semi-structured interviews will be conducted to explore the links between context, feeling, involvement, decision and actions during pregnancy, whether within the couple or in its environment.
15881174|NCT03795844|Procedure|liver retraction Nathanson retractor|liver retractor will be used for the retraction of left lobe of liver
15881175|NCT03795844|Procedure|liver retraction snake retractor|liver retractor will be used for the retraction of left lobe of liver
15881176|NCT03795844|Procedure|liver retraction fan retractor|liver retractor will be used for the retraction of left lobe of liver
15881177|NCT03795844|Procedure|liver retraction laparoscopic grasper|laparoscopic grasper without any special tools
15881178|NCT03795831|Device|ClearSight feasibility testing|A cuff is placed on a finger of the patient. The ClearSight system uses a volume clamp technology allowing measuring of continuous blood pressure waveform. Note: There will only be observational recordings, no interventions
15881179|NCT03795818|Behavioral|Interpersonal Psychotherapy for Adolescents|IPT-A is a psychosocial intervention for adolescents that focuses on improving interpersonal relationships that seem to be associated with the psychiatric symptoms.
15881185|NCT03795779|Biological|CLL1-CD33 cCAR T cells|CLL1-CD33 cCAR T cells transduced with a lentiviral vector to express two distinct units of anti-CLL1 and CD33 CARs.
15881186|NCT03795766|Procedure|Surgeries for gynecologic disease|All patients accept surgeries for gynecologic disease.
15881187|NCT03795753|Device|F2S Communicator|"The communicator will be attached to the BPAP/CPAP mask. The study coordinator will ENABLE the communicator. A list of single words and 5-word through 15-word sentences will be provided to the patient. Each single word may be read aloud up to two times. The partner must then select the read word out of a list of twelve possible words. Each sentence may be read aloud up to two times. The partner must transcribe each sentence on a standardized form. A survey will be provided to evaluate the mask on, communicator on period."
15881188|NCT03795753|Other|Non-functioning Communicator|"The communicator will be attached to the BPAP/CPAP mask. The study coordinator will DISABLE the communicator. A list of single words and 5-word through 15-word sentences will be provided to the patient. Each single word may be read aloud up to two times. The partner must then select the read word out of a list of twelve possible words. Each sentence may be read aloud up to two times. The partner must transcribe each sentence on a standardized form. A survey will be provided to evaluate the mask on, communicator on period."
15881189|NCT03795740|Diagnostic Test|3-D CT scanning|For patients in Group 1,precisely analyzed CT scanning and/or pulmonary angiography will be done,and the patients in Group 1 will receive PEA procedure with the guide of precise 3-D imaging techniques
15881190|NCT03795727|Device|MD ring and precontoured sectional matrix by TOR VM|MD ring (separation ring) and precontoured sectional matrix (thickness 0.035mm hard) and a wedge was used to secure matrix in place
15881191|NCT03795727|Device|Circumferential matrix and tofflemire retainer by Kerr|Circumferential matrix (thickness 0.038mm) applied by tofflemire retainer and secured in place with wedge
15881192|NCT03795714|Diagnostic Test|IVUS or OCT and Invasive physiologic indices|IVUS or OCT measurement in order to evaluate the lesion morphology and stent optimization, and invasive physiologic measurement in order to functional significance of epicardial stenosis
15881193|NCT03795701|Drug|Saxenda®|Receiving escalating dose of Saxenda® for the first 4 weeks (0.6mg, 1.2mg, 1.8mg, 2.4 mg) and receiving full-dose (3.0 mg) for 12 weeks.
15881194|NCT03795701|Other|Placebo|Receiving equivalent volumes of the pre-filled solutions from pen-injector as Liraglutide 3.0 group .
15881195|NCT03795688|Other|Pregnancy|Peripartum transition from pregnant to postpartum state
15881196|NCT03795675|Device|Cochlear Implant|Cochlear implant device to be implanted at time of surgical intervention.
15881197|NCT03795662|Other|No intervention|Obervational
15881198|NCT03795649|Drug|Tranexamic Acid|Imunomodulatory effect
15881199|NCT03795636|Other|Garlic extract|A 100 gram of garlic cloves has been cleaned, peeled and dried. Ethanol of 70% concentration was added for 60 seconds. The cloves were placed in a laminar airflow chamber for evaporation of residual ethanol. Using a sterile mortar and pestle, cloves were homogenized aseptically and filtered through a double layer paper. The fully concentrated extracted was diluted to the concentration of 25% with distilled water
15881200|NCT03795636|Other|NaOCl (COLTENE®)|Sodium hypochlorite
15881201|NCT03795623|Other|Voice-Weaning|Audio recordings of patients' relatives for 10 minutes x 3 daily from initiation of assisted mechanical ventilation to extubation or ICU discharge.
15881202|NCT03795623|Other|Sham control|Muted audio recordings of patients' relatives for 10 minutes x 3 daily from initiation of assisted mechanical ventilation to extubation or ICU discharge.
15881203|NCT03795610|Drug|IPI-549|40mg by mouth (PO) every day (QD) for at least 21 days
15881204|NCT03795597|Drug|Carfilzomib|Carfilzomib is an anti-cancer drug acting as a selective proteasome inhibitor that is used to treat Multiple Myeloma.
15881205|NCT03795597|Drug|Busulfan IV|Busulfan is an anti-cancer drug acting as a bifunctional alkylating agent that is used to treat Multiple Myeloma.
15881206|NCT03795597|Drug|Melphalan IV|Melphalan is an anti-cancer drug acting as alkylating agent that is used to treat Multiple Myeloma.
15881207|NCT03795584|Procedure|sterile repositionable hemostasis clipping device close the large duodenal papilla incision|After the bile duct stent was placed, the investigators can use sterile repositionable hemostasis clipping device to close large duodenal papilla incision at 11 o'clock on the duodenal papilla.
15881208|NCT03795571|Drug|Rituximab|Rituximab 375mg/m2，d0
15881209|NCT03795571|Drug|Gemcitabine|Gemcitabine 1000mg/m2，d1，d5
15881210|NCT03795571|Drug|Oxaliplatin|Oxaliplatin 75mg/m2，d1
15881211|NCT03795571|Drug|Dexamethasone|Dexamethasone 40mg/d，d1~d4
15881212|NCT03795571|Drug|Lenalidomide Oral Capsule|Lenalidomide 10mg/d、15mg/d、20mg/d、25mg/d d1~d10； 21days a cycle
15881213|NCT03795558|Drug|Etelcalcetide|Up-Titration
15881214|NCT03795545|Procedure|SWL|Shock wave lithotripsy
15881215|NCT03795532|Procedure|SWL|Shock wave lithotripsy
15881216|NCT03795519|Drug|[14C]-olinciguat|oral capsule
15881217|NCT03795506|Device|Nocturnal Temperature controlled Laminar Airflow (TLA) Treatment|12 weeks of overnight treatment with active TLA device
15881218|NCT03795506|Device|Placebo TLA Device|12 weeks of overnight use of placebo TLA device
15881219|NCT03795493|Behavioral|Short-term diet and exercise intervention|Participants assigned to the intervention group will perform both the diet and acute exercise interventions. The interventions will be applied prior to up to six chemotherapy cycles of a consistent protocol. The total number of treatments of a given protocol received prior to treatment conclusion is dependent on patient condition and oncologic care preferences.
15881220|NCT03795480|Behavioral|MOOD|MOOD is an online self-help program targeted on depressive symptoms. The program consists of nine modules, one of which is an introductory module. The other modules are called: ABC-Scheme, Positive Activities, Self-Worth, Social Competence, Mindfulness, Modifying Thoughts, Sleep, and Relapse Prevention. All modules are based on principles of cognitive behavioral therapy (CBT) and include elements of mindfulness-based and metacognitive techniques. The modules contain interactive exercises which are aimed at incorporating the participant's experiences into the program and increasing identification of the participant with the presented material. Participants are free to work through the different modules in their own speed and way, however, it is recommended to work on one to two modules per week.
15881399|NCT03794141|Behavioral|life style advise|all test persons were given information on healthy diet and life style
15890675|NCT03722173|Drug|Itraconazole|Oral solution
15881221|NCT03795454|Behavioral|Singing|Infant-directed singing and singing of self-invented songs, especially songs emerging from the interaction with the infant, are especially encouraged. The families will receive audio material of children's songs, lullabies, and lyrics of the lullabies to support them if they feel unable to accomplish the task otherwise.
15881222|NCT03795441|Biological|Ad26.RSV.preF|Ad26.RSV.preF will be administered as intramuscular injection on Day 1.
15881223|NCT03795428|Drug|Pemziviptadil (PB1046) Injection|Once-weekly subcutaneous injection
15881224|NCT03795415|Behavioral|Gundo So|"Gundo-So was adapted from a program established in quebec. It has been implemented in Mali following 3 phases: 1) cultural adaptation; 2) validation using a pre-post intervention evaluation; 3) scale-up
~The programm consists on 9 group meetings group spread over 9 weeks (for 8 WLHIV + 2 trained community-based leaders). Each meeting has some particular thematics with adapted tools."
15881225|NCT03795402|Device|Microneedle Device|Microneedle device will be used for collecting skin samples as a non-invasive method.
15881226|NCT03795389|Drug|DM199|Single SC dose
15881227|NCT03795363|Drug|Orkambi|Orkambi is a novel approved therapy for use in people homozygous for the F508del mutation in the CFTR gene. It is a combination of lumacaftor (VX-809) and ivacaftor( VX-770) that addresses both the processing and gating defects of the F508del mutation. The small-molecule corrector lumacaftor corrects the F508del processing defect and increases epithelial delivery of CFTR protein1. Ivacaftor is a CFTR potentiator that increases the channel open probability in F508del-mutant CFTRs that undergo epithelial delivery in vitro and has an additive effect with lumacaftor on chloride transport (2,3,4,5).
15881228|NCT03795350|Drug|Beclometasone dipropionate Formoterol Fumarate Glycopyrronium Bromide|single inhalation of 99mTc radiolabelled TRIMBOW pMDI (4 puffs for a total dose of 400mcg BDP, 24mcg FF, 50 mcg GB)
15881229|NCT03795337|Radiation|Hypofractionated Radiosurgery|"Image-guided stereotactic Linac based RT preferable with dedicated radiosurgery system such as CyberKnife"
15881230|NCT03795324|Other|Redlove Apple intervention|The bioactive compounds present in this product are anthocyanins (50mg per 80g of product).It was a 6 weeks nutritional intervention. Volunteers will eat 80g per day of lyophilized redlove apple.
15881231|NCT03795324|Other|Green Apple intervention|It was a 6 weeks nutritional intervention. Volunteers will eat 80g per day of lyophilized green apple.
15881232|NCT03795324|Other|Aronia drink intervention|The bioactive compounds present in this extract are anthocyanins (50mg per 1L of water).It was a 6 weeks nutritional intervention. Volunteers will drink 1L per day of an aronia drink
15881233|NCT03795311|Drug|FOLFIRINOX Bevacizumab|"In phase 1, the goal is to define the DLT (maximum tolerated dose). 3 levels of doses will be evaluated with a different dose of irinotecan in each level.
~Level -1: Bevacizumab + Oxaliplatine + Acide folinique + Irinotecan: 60mg / m2
~Level 0: Bevacizumab + Oxaliplatine + Acide folinique +Irinotecan: 70mg / m2
~Level 1: Bevacizumab + Oxaliplatine + Acide folinique +Irinotecan: 90mg / m2
~The inclusion of patients will start at level 0. Dose-limiting toxicities will be identified during the first 2 cycles."
15881234|NCT03795298|Device|WATCHMAN FLX Implant|Left atrial appendage closure with the WATCHMAN FLX device
15881235|NCT03795298|Drug|Market-approved OAC|Used per IFU for atrial fibrillation stroke prevention for the duration of the trial.
15881236|NCT03795285|Diagnostic Test|Expression of neutrophil CD64|Expression of neutrophil CD64 will be measured by Flow cytometry. In addition, sTREM-1 will be measured in the serum by ELISA
15881237|NCT03795272|Drug|Rucaparib|2:1 randomization to receive rucaparib/placebo twice daily for 24 month
15881238|NCT03795272|Drug|Placebo|placebo
15881239|NCT03795259|Drug|Rocuronium|After induction, rocuronium 0.6 mg/kg will be given by intravenously and patients will be orotracheal intubated when TOF value reaches 0%.
15881240|NCT03795259|Drug|Sugammadex|Continuous TOF measurement will continue until the value reaches %25. At this time, sugammadex 2 mg/kg will be given intravenously.
15881241|NCT03795246|Procedure|Consultation|Consultation in oncology: collection of oncological data and ongoing cancer treatments, clinical exam Consultation in gynecology: collection of gynecological data, contraception and reproductive medicine
15881242|NCT03795246|Biological|Biological Test|"Blood test:
~FSH, LH, E2 and AMH
~4 tubes of 7 mL"
15881243|NCT03795246|Procedure|Pelvic Ultrasound|Antral Follicles Count
15881244|NCT03795233|Biological|Fecal microbiota transplant G3 capsules|After standard of care therapy with oral vancomycin, frozen oral FMT capsules will be provided in a formulation designed to deliver the product to the large intestine. 30 FMT capsules will be administered over a 2 hour period under direct observation
15881245|NCT03795233|Other|Oral Vancomycin alone|Standard of care will be provided with oral vancomycin therapy.
15881246|NCT03795220|Drug|Lutinus + transfer day 6|Four parallel groups of patients undergoing fertility treatment (modified natural cycle frozen embryo transfer) will be compared using/not using vaginal progesterone (Lutinus) and subject to blastocyst warming and transfer 6/7 days after hCG trigger.
15881247|NCT03795220|Drug|Lutinus + transfer day 7|Four parallel groups of patients undergoing fertility treatment (modified natural cycle frozen embryo transfer) will be compared using/not using vaginal progesterone (Lutinus) and subject to blastocyst warming and transfer 6/7 days after hCG trigger.
15881248|NCT03795220|Drug|No Lutinus + transfer day 6|Four parallel groups of patients undergoing fertility treatment (modified natural cycle frozen embryo transfer) will be compared using/not using vaginal progesterone (Lutinus) and subject to blastocyst warming and transfer 6/7 days after hCG trigger.
15881249|NCT03795220|Drug|No Lutinus + transfer day 7|Four parallel groups of patients undergoing fertility treatment (modified natural cycle frozen embryo transfer) will be compared using/not using vaginal progesterone (Lutinus) and subject to blastocyst warming and transfer 6/7 days after hCG trigger.
15881250|NCT03795207|Combination Product|SBRT + Durvalumab|"Durvalumab, MEDI4736, is a immunotherapy,
~SBRT (stereotactic body radiotherapy) is a procedure that uses high doses of radiation delivered to a precise target. By using special positioning and implanted markers in the body, radiologists are able to deliver a much higher dose of radiation to a cancer than traditional radiation therapy"
15881251|NCT03795207|Radiation|SBRT|SBRT (stereotactic body radiotherapy) is a procedure that uses high doses of radiation delivered to a precise target. By using special positioning and implanted markers in the body, radiologists are able to deliver a much higher dose of radiation to a cancer than traditional radiation therapy
15881252|NCT03795194|Drug|ampicillin/clavulanate|FDA-approved antibiotic
15881253|NCT03795168|Device|Transcranial vibrating system|The transcranial vibrating system (TCVS) will be worn by participants performing vestibular physical therapy (PT) exercises. The TCVS vibrating element will be placed against the skull, preferably over the mastoid bone behind the ear and will be hold in place by a headband. The TCVS will be worn during the whole time of the vestibular PT exercise (30 minutes) or less if the participant is unable to complete its exercises. The TCVS will be set at an optimal vibration frequency as determined in a previous study.
15881254|NCT03795168|Device|Transcranial vibrating system sham|A transcranial vibrating system (TCVS) sham set at an irrelevant vibrating frequency will be worn by participants performing vestibular physical therapy (PT) exercises in arm 2. The TCVS sham vibrating element will be placed against the skull, preferably over the mastoid bone behind the ear and will be hold in place by a headband. The TCVS sham will be worn during the whole time of the vestibular PT exercise (30 minutes) or less if the participant is unable to complete its exercises.
15881255|NCT03795142|Biological|BGB149|Single Ascending Dose
15881256|NCT03795142|Biological|Placebo|Matching placebo
15881257|NCT03795129|Behavioral|SleepLife Application w/FitBit|"Subjects receive a FitBit. Subjects receive access to the SleepLife Application. Subjects receive training and assistance setting up use and access to the SleepLife Application.
~Subjects' physicians will receive subject sleep data. Subjects and physicians have the option of messaging each other through the SleepLife application."
15881258|NCT03795129|Behavioral|FitBit w/Minimal to No SleepLife App.|"Subjects will receive a FitBit. Subjects will be told about the SleepLife Application (but not be shown how to access it).
~Subjects will receive no training with regard to how to access SleepLife Application.
~Subjects' physicians will receive no subject sleep data."
15881259|NCT03795116|Device|LED-RL phototherapy|The LED-RL treatment device has a 4.7 cm x 6.1 cm rectangular array of LEDs and emits visible red light (633 nm) at a power density of 360.2 W/m2 at room temperature and a distance of 10 mm from the target surface.
15881260|NCT03795116|Device|Mock irradiation|The mock therapy device is designed to sound, look, and feel identical to the LED-RL treatment device (i.e., has the same physical components and thermal output), except it does not emit visible red light.
15881261|NCT03795103|Device|neuromuscular electrical stimulator|A 12-week program of neuromuscular electrical stimulation
15881262|NCT03795103|Other|Walking sessions|A 12-week program of walking sessions performed outdoors and independently
15881263|NCT03795103|Other|Advices|The usual practice associated with an information leaflet outlining tips for active living and walking.
15881264|NCT03795090|Combination Product|Regular Patient privacy curtain|Laundered curtains, used in the hospital, coming from the hospital inventory.
15881265|NCT03795090|Combination Product|Antimicrobial Coated curtains|Antimicrobial coating consist of active polymers that are approved by USFDA and USEPA.
15881266|NCT03795077|Other|Experimental group|Experimental group followed the 3-months programme based in professional ethics. A specific syllabus about Professional Ethics was developed. It consisted of 6 themes and included topics as moral values, ethics and moral, bioethics and professional ethics, ecc. Six related activities were created: to solve situations related to real clinical practices. Face to face group sessions based on cooperative learning were planned. Students were divided in small groups, and active participation techniques were used.
15881267|NCT03795064|Procedure|Foam sclerotherapy|Foam sclerotherapy is used to all patients for endovenous ablation of insufficient veins in subulcer plexus area.
15881268|NCT03795064|Procedure|Endothermal ablation|Endothermal ablation is performed in early setting when truncal vein(s) anatomy is suitable.
15881269|NCT03795051|Device|Navigated Transcranial Magnetic Stimulation|This study is a feasibility trial. Each participant will receive 30sessions of 10 Hz or 20 Hz rTMS over the left DLPFC. The rTMS interventions will be guided by a neuronavigation system (StimGuide TMS Navigation System, Magstim, Ltd. Carmarthenshire, UK) for navigation to the treatment location and to ensure consistent placement and orientation of the coil during and between each session. For the purpose of this protocol, these sessions are referred to as nTMS.
15881270|NCT03795038|Device|Lipoprotein Apheresis MONET and DALI|Three apheresis treatments assigned to one type of apheresis system of MONETand DALI
15881271|NCT03795038|Device|Lipoprotein Apheresis DIAMED and DALI|Three apheresis treatments assigned to one type of apheresis system of DIAMOND and DALI
15881272|NCT03795025|Other|Strength training 3x10RM + no training|Progressive unilateral strength training 3 times per week for 3 + 7 weeks. One leg exercises with 3 sets of 10 maximal repetitions, the other leg does not exercise.
15881273|NCT03795025|Other|Strength training 6x10RM + no training|Progressive unilateral strength training 3 times per week for 3 + 7 weeks. One leg exercises with 6 sets of 10 maximal repetitions, the other leg does not exercise.
15881274|NCT03795025|Other|3x10RM + 6x10RM|Progressive unilateral strength training 3 times per week for 3 + 7 weeks. One leg exercises with 3 sets of 10 maximal repetitions, the other leg exercises with 6 sets of 10 maximal repetitions.
15881275|NCT03795012|Drug|Eribulin|Patients will receive eribulin injections intravenously on days 1 and 8 of every 21-day cycle alone.
15881278|NCT03794986|Behavioral|Trauma-informed SGM affirmative care|"All SGM male survivors who meet inclusion criteria, including significant emotional distress, will complete pre-test measures and be randomized to 6-week Motivational Interviewing (MI) delivered by peers in online groups or 6-week MI with trauma-informed, SGM affirmative care delivered by peers in online groups.
~Participants will complete pre-intervention (baseline), end of the 6-week intervention, 60- and 120-days follow-up assessments via an online survey platform, to determine if there was an increase in formal treatment engagement, and any significant changes in mental health symptomology (i.e., PTSD, depression, high-risk drinking, and illicit substance use)."
15881400|NCT03794128|Procedure|Blood collection for research (next-generation sequencing [NGS])|Participants will have whole blood collected for next-generation sequencing (NGS).
15881279|NCT03794986|Behavioral|Motivational Interviewing|"Major principles and tenets of Motivational Interviewing (MI) group include: Non-confrontational nature of group; environment is one of respect, safety, and encouragement of all group members; purpose is to learn about members' personal thoughts and choices and not to push an agenda"
15881280|NCT03794973|Biological|TOL-3021|TOL-3021 1 mg is a bacterial plasmid expression vector containing the coding sequences for the human proinsulin (hINS) gene.
15881281|NCT03794973|Other|TOL-3021 Placebo|TOL-3021 Placebo
15881282|NCT03794960|Biological|TOL-3021|A plasmid expression vector containing the coding sequences for full-length human proinsulin.
15881283|NCT03794960|Other|TOL-3021 Placebo|TOL-3021 Placebo
15881284|NCT03794947|Procedure|Remote Ischaemic Conditioning|Induced ischaemia to a limb by inflating pressure cuffs around arms or legs to above systolic pressures (mmHg).
15881285|NCT03794947|Procedure|Sham Intervention|The sham intervention will inflate pressure cuffs to much lower levels for the same number of cycles.
15881286|NCT03794934|Behavioral|Structured Education for new glucose management devices|Individualized professional education based on new glucose management devices in patients with type 1 diabetes mellitus
15881287|NCT03794921|Other|Every Step Counts|Pedometer coupled to a website that provides step-count goals, feedback, education, motivation, and social support.
15881288|NCT03794908|Device|Light therapy A via the Re-Timer®|Subjects will conduct light treatment in the mornings at home for one hour using Re-timer®.
15881289|NCT03794908|Device|Light therapy B via the Re-Timer®|Subjects will conduct light treatment in the mornings at home for one hour using Re-timer®.
15881290|NCT03794895|Device|Doppler|Doing doppler for women having IUCD associated menorrhagia
15881291|NCT03794882|Procedure|Quadratus Lumborum Block|30 mL of .25% bupivacaine with 2.5mcg/mL epinephrine will ne injected on both sides of the mid-abdomen posterior to the mid-axillary line.
15881292|NCT03794882|Procedure|Standard Medical Management|Standard medical management typically includes perioperative multimodal analgesia utilizing acetaminophen, opioids, non-steroidal anti-inflammatory drugs, and dexamethasone
15881293|NCT03794869|Other|Percutaneous electrostimulation treatment (EPS)|Apply dry needles in a tight band of some of the muscles that most affect the appearance of low back pain, such as: paravertebral, lumbar quadrate, gluteus medius and pyramidal, and administer analgesic microcurrents.
15881294|NCT03794869|Other|Exercise program|It will be consist in a program of lumbo-pelvic stabilization exercises and strengthening of CORE.
15881295|NCT03794856|Other|Functional and Structural Magnetic Resonance Imaging (research grade)|Brain structure and function will be compared in middle to late-age adults with asthma compared to healthy adults.
15881296|NCT03794856|Other|Cognitive Function Testing (non-diagnostic)|Multiple domains of cognitive functioning will be investigated, including processing speed, executive functioning/working memory and episodic memory.
15881297|NCT03794856|Other|Asthma and Psychological Questionnaires (non-diagnostic)|Participants will fill out asthma and psychological questionnaires (non-diagnostic)
15881298|NCT03794843|Drug|Nimodipine Injection|Nimodipine injection (trade name: Nimotop) manufactured by Bayer Pharma AG was used as the reference preparation
15881299|NCT03794843|Drug|Nimodipine Injection (II)|Nimodipine Injection (II) was supplied by Shenyang Dongxing Pharmaceutical Technology Co., Ltd
15881300|NCT03794830|Other|manipulation group (MG)|Patients were treated with sacroiliac joint osteopathic semidirect manipulation twice a week every 3 to 4 days over a period of time of 3 weeks
15881301|NCT03794830|Other|electrotheraphy group (EG)|Patients were treated with micro-waves (circular antenna in lumbar area, pulsating-mode 120W for 12 minutes) and later conventional analgesic TENS (80Hz frequency, 30 minutes) 5 days per week over a period of time of 3 weeks (15 sessions)
15881302|NCT03794804|Device|ColdZyme|"ColdZyme® Mouth Spray, a CE -marked device with the following composition of the spray solution: glycerol, purified water, cod trypsin, ethanol (<1 %), calcium chloride, trometamol and menthol.
~ColdZyme is a non-sterile mouth spray packaged in a primary container consisting of a 20 ml semi-transparent plastic bottle, pump, actuator (spray nozzle) and an actuator terminal cap."
15881303|NCT03794804|Device|ColdZyme Placebo|The placebo mouth spray solution has the following composition: ethanol (<1 %), menthol and water. The placebo mouth spray is packaged in a primary container consisting of a 20 ml semitransparent plastic bottle, pump, actuator (spray nozzle) and an actuator terminal cap.
15881304|NCT03794791|Behavioral|education|Education Methods including video playing of HCV Introduction (disease profile, risk factors for infection, outcomes, HBV/HCV coinfection, reinfection, etc) for 5 min, booklets of relative information distribution, physicians and nurses consulting in clinic.
15881305|NCT03794791|Behavioral|no education|Education Methods including video playing of HCV Introduction (disease profile, risk factors for infection, outcomes, HBV/HCV coinfection, reinfection, etc) for 5 min, booklets of relative information distribution, physicians and nurses consulting in clinic.
15881306|NCT03794778|Drug|pegylated liposomal doxorubicin|PLD 30 mg/m2, i.v.,d1; once every 21days
15881307|NCT03794778|Drug|paclitaxel|paclitaxel 175 mg/m2, i.v.,d1; once every 21days
15881308|NCT03794778|Drug|Carboplatin|carboplatin AUC 5, i.v.,d1; once every 21days,
15881309|NCT03794765|Drug|Ceftriaxone|Injection ceftriaxone 1 gm will be prepared by reconstitution of the crystallised powder form in 100 ml of normal saline. This preparation will then be infused slowly over thirty minutes, after intradermal testing for hypersensitivity. Inj ceftriaxone 1gm IV will be given twelve hourly.
15881310|NCT03794765|Drug|Metronidazole|Injection metronidazole 500 mg is available from pharmacies in solutions of 100 ml. It will be infused slowly over thirty minutes, three times per day
15881311|NCT03794765|Other|Placebo infusion|Similar placebo infusion
15881312|NCT03794752|Device|Head-Mounted Visual Enhancement Device|Evergaze has designed a head mounted electronic visual enhancement device that is compact and similar to glasses. It is powered by a battery pack connected to the device. The electronic display will be affixed over only one of the participant's eye. The vision through the unobstructed eye will aid with the participant's balance and spatial orientation. The prototype display and camera will be connected to a battery pack/control box that will allow the user to quickly select one of 3 modes. Each mode will represent a combination of parameters (brightness of the display, focus lock, color/black & white, contrast, magnification) designed to optimize the image for different activities (e.g. reading, walking, computer use).
15890676|NCT03722173|Drug|BI 894416|Tablet
15881313|NCT03794726|Procedure|Orthodontic Molar Protraction and PAOO|Molar Protraction with Orthodontic Tooth Movement and Adjunctive Periodontally Accelerated Osteogenic Orthodontics (PAOO) Surgery was performed on all study sites in this arm in coordination with standard orthodontic molar protraction using traditional bands/brackets and orthodontic wires.
15881314|NCT03794726|Procedure|Orthodontic Molar Protraction|Standard orthodontic molar protraction using traditional bands/brackets and orthodontic wires.
15881315|NCT03794713|Device|Patient support tool|The patient support tool, a software app installed on the smart phones plus a wrist connected to the smart phones by Bluetooth. The wrist could monitor the pulse, which was recorded to the app in the smart phone. Meanwhile, the app could inform to patients about the importance of medication, remind on the medicine intake, share the patients' data with themselves, and warn the patients if the wrist don't wear.
15881316|NCT03794700|Other|Hospice Decision Aids|Paper and video hospice decision aid
15881317|NCT03794687|Procedure|Left heart catheterization|Catheterization via the distal radial artery
15881318|NCT03794674|Other|No intervention.|No intervention, since this is a validation study
15881319|NCT03794661|Device|Clinician programmer electrode screening mode tool|Provides a standardized workflow to guide clinicians or trained healthcare providers through the deep brain stimulation monopolar review screening process
15881320|NCT03794648|Behavioral|Mobile Interactive Supervised Therapy (MIST)|MIST system will send a reminder notification (via push or SMS) to participants 10 to 15 minutes before the scheduled time for taking their medication. Participants will then activate the recording function of the MIST app on their phone, and record themselves taking their medication.Participants will be asked to go through a series of steps for recording the video.
15881321|NCT03794635|Behavioral|Weekly 45 minute Sessions|"The current intervention consists of seven, weekly,45-minute sessions conducted over the telephone using the TAC manual workbook. MSK-approved platforms (such as Webex or Cisco Jabber) can be used for telephone calls in this study. There will be two versions of the intervention used for this study:
~A culturally tailored version for Latinx participants refined during Phase 1 of this study (available in English and Spanish)
~A version of the intervention that was not culturally tailored for Latinx patients and caregivers developed in previous work. The two interventions differ in minor content areas. The culturally tailored intervention for Latinx participants and the non-tailored intervention for non-Latinx participants will be used. Interventions will occur weekly with a plus three-week window.
~Characteristics of prognostic discussions between patients and caregivers and health providers will be assessed at baseline and post-intervention."
15881322|NCT03794622|Other|intramedullary nail fixation with bone marrow concentration|intramedullary nail fixation with bone marrow concentration
15881323|NCT03794622|Other|intramedullary nail fixation|intramedullary nail fixation only
15881324|NCT03794596|Drug|Avelumab|Colourless odourless aqueous solution for infusion at dose of 10mg/kg
15881325|NCT03794596|Drug|Aspirin|300mg tablets
15881326|NCT03794596|Drug|Lansoprazole (Proton Pump Inhibitor)|300mg capsule
15881327|NCT03794583|Drug|Inhaled treprostinil solution|Inhaled treprostinil solution per dose and schedule specified in the arm
15881328|NCT03794570|Device|Blood flow restriction therapy - with Delfi Personalized Tourniquet System|Physical therapy performed with Blood flow restriction therapy tourniquet inflated to 80% limb occlusion pressure
15881329|NCT03794570|Device|Sham blood flow restriction therapy - with Delfi Personalized Tourniquet System|Physical therapy performed with Blood flow restriction therapy tourniquet inflated to only minimal pressure
15881330|NCT03794557|Drug|Sterile Water Injection|Inhaled Sterile Water Injection
15881331|NCT03794557|Drug|PUL-042 Inhalation Solution|PUL-042 Inhalation Solution
15881332|NCT03794544|Drug|Durvalumab|Durvalumab
15881333|NCT03794544|Combination Product|Durvalumab + Oleclumab|Durvalumab + Oleclumab
15881334|NCT03794544|Combination Product|Durvalumab + Monalizumab|Durvalumab + Monalizumab
15881335|NCT03794544|Combination Product|Durvalumab + Danvatirsen|Durvalumab + Danvatirsen
15881336|NCT03794518|Drug|Pioglitazone Plus dapaglifliozin|Pioglitazone Plus dapaglifliozin
15881337|NCT03794518|Drug|Placebo|(Beta blockers, ACEI, ARB, and aldosterone )
15881338|NCT03794505|Drug|Methylprednisolone Acetate|depo-medrol 40 mg
15881339|NCT03794505|Drug|Lidocaine 2% Injectable Solution|2ml of 2% lidocaine
15881340|NCT03794505|Drug|Ropivacaine HCl Inj 7.5 MG/ML|25 mg
15881341|NCT03794492|Drug|Mycophenolate mofetil 500mg Tab. or 250mg Cap.|- Orally, up to 1g BID(total 2g daily)
15881342|NCT03794492|Drug|Tacrolimus|- Orally, check the blood ceocentration of tacrolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3-8ng/ml
15881343|NCT03794492|Drug|Methylprednisolone/prednisolone|- Methyprednisolone 500mg / Prednisolone 5mg
15881344|NCT03794492|Drug|Basiliximab|- IV, 20mg(before Kidney transplat) / 20mg(Day 4 of kidney transplant)
15881345|NCT03794440|Drug|Sintilimab|200mg IV d1， Q3W
15881346|NCT03794440|Drug|IBI305|15mg/kg IV d1， Q3W
15881347|NCT03794440|Drug|Sorafenib|400mg PO BID
15881348|NCT03794427|Other|unilateral lumbosacral nerve block|Patients will receive unilateral lumbosacral nerve block (sciatic nerve block and paravertebral block at levels L3-L4 and L4-L5). The sciatic nerve will be injected by 20 ml of the anesthetic mixture whereas levels L3-L4 and L4-L5 will be injected by a total of 20 ml of the anesthetic mixture without exceeding the maximum injected volume of 1 ml/kg.
15881349|NCT03794427|Other|Spinal anesthesia|Patients will receive spinal anesthesia (3 ml of 0.5% bupivacaine)
15881350|NCT03794427|Other|Placebo at the spinal anesthesia level|Patients will receive 1 ml normal saline at the spinal anesthesia level (L3-L4 or L4-L5).
15881351|NCT03794427|Other|Placebo at lumbosacral level|Patients will receive normal saline at the sciatic, L3-L4 and L4-L5 levels
15881352|NCT03794414|Procedure|PEEP challenge|apply PEEP 10 mmHg in one-lung ventilating patients.
15881353|NCT03794388|Drug|Capsaicin|Application of capsaicin patches at 8% on painful area
15881354|NCT03794388|Drug|Pregabalin|Taking Pregabalin tablets
15881401|NCT03794128|Procedure|Blood collection for research (HLA typing)|Participants will have whole blood collected for HLA typing.
15881402|NCT03794115|Procedure|Treatment for ovarian cancer|The treatment for ovarian cancer includes the debulking surgery and platinum-based chemotherapy.
15881355|NCT03794375|Other|Telehealth|After 45 days after the estimated date of the consultation (6 months after discharge), the Telehealth staff will contact the patient to check if the consultation was actually performed. When individuals report difficulty accessing the unit, contact will be made to the primary care teams and the Telehealth staff will schedule the appointment. A new contact will be made in 12 months to verify if the consultation was actually performed.
15881356|NCT03794375|Other|Usual care|The patients will remain in care at the HCPA thyroid disease outpatient clinic during the study period. This follow-up will be done by endocrinologists, and the patients will undergo clinical, biochemical (TSH, thyroglobulin, and antithyroglobulin) and radiological (cervical ultrasound) tests to seek disease recurrence. The patient's consultation will be done one or twice a year.
15881362|NCT03794336|Drug|Alogliptin|"Pharmaceutical form: tablet
~Route of administration: oral administration"
15881363|NCT03794336|Drug|Acarbose|"Pharmaceutical form: tablet
~Route of administration: oral administration"
15881364|NCT03794336|Drug|Metformin|"Pharmaceutical form: tablet
~Route of administration: oral administration"
15881365|NCT03794336|Drug|Aspirin|"Pharmaceutical form: tablet
~Route of administration: oral administration"
15881366|NCT03794323|Drug|BI 764122|Tablet
15881367|NCT03794323|Drug|Placebo|Tablet
15881368|NCT03794310|Drug|NPF-08 （1-day treatment）|NPF-08 will be administered on the day of colonoscopy.
15881369|NCT03794310|Drug|NPF-08 （2-day split dose）|NPF-08 will be administered at 2 days divided into the day before and on the day of colonoscopy.
15881370|NCT03794310|Drug|Moviprep（1-day treatment）|Moviprep will be administered on the day of colonoscopy.
15881371|NCT03794297|Drug|Dabrafenib Mesylate|Given PO
15881372|NCT03794297|Other|Quality-of-Life Assessment|Ancillary studies
15881373|NCT03794297|Other|Questionnaire Administration|Ancillary studies
15881374|NCT03794297|Drug|Trametinib Dimethyl Sulfoxide|Given PO
15881375|NCT03794284|Diagnostic Test|VereMTB|At least 2 mL of patient's expectorated or induced sputum would be collected for VereMTB assay and their clinical data would be retrieved for analysis use.
15881376|NCT03794271|Procedure|Pupilometer guided anesthesia|"At least 10 min after anesthesia induction by target-controlled infusion of propofol and remifentanil, baseline values for pupillary diameter is recorded before any surgical procedure.
~During the operation, propofol effect-site target concentration (Ce) is adjusted to maintain the bispectral index (BIS) value between 40 and 60. Remifentanil Ce is adapted every 5 min based on the changes of pupillary diameter. If the pupillary diameter is increased by more than 30% compared to baseline value, remifentanil concentration is increased by 0.5 ng/ml. If the pupillary diameter is maintained between 5 and 30 % change compared with baseline, remifentanil is not modified. In a case of pupillary diameter is decreased less than 5 % change of baseline, remifentanil concentration is decreased by 0.5 ng/ml."
15881377|NCT03794271|Procedure|SPI guided anesthesia|During the operation, SPI value should be maintained between 20 and 50 by changing the infusion rate of remifentanil. Even if the SPI is maintained within the target range, the remifentanil infusion rate is increased by 0.5 ng/ml in a case of the SPI value suddenly arises by more than 10.
15881378|NCT03794258|Drug|SOF+DCV+CDI-31244|Sofosbuvir (SOF) 400 mg administered orally once daily; Daclatasvir (DCV) 60 mg administered orally once daily; CDI-31244 400 mg administered orally once daily.
15881379|NCT03794258|Drug|SOF+DCV+CDI-31244+ASV|Sofosbuvir (SOF) 400 mg administered orally once daily; Daclatasvir (DCV) 60 mg administered orally once daily; CDI-31244 400 mg orally once daily; Asunaprevir (ASV) 200mg administered orally twice daily.
15881380|NCT03794245|Behavioral|Men-Centered HIV Testing|The intervention involves bringing mobile HIV testing to venues where men congregate, talking to them as a group about HIV testing, and then providing testing at that venue.
15881381|NCT03794245|Behavioral|Linkage to Care for HIV+ Men|Men diagnosed with HIV are accompanied to the clinic and registered there with the help of a community health worker.
15881382|NCT03794245|Behavioral|Clinic-based HIV Testing|Individuals present to a clinic and request HIV counseling and testing
15881383|NCT03794245|Behavioral|Clinic Referral for HIV+ Men|Individuals diagnosed with HIV are referred to the nearest clinic for treatment of HIV
15881384|NCT03794232|Dietary Supplement|NIUCHANG|
15881385|NCT03794232|Dietary Supplement|Placebo|
15881386|NCT03794219|Other|Kinesio Tape|To all patients,750 mg/day oral naproxen is administered for 10 days. Additionally, in intervention group kinesio tape is applied 3 times a week for 2 weeks with a total of 6 sessions.
15881387|NCT03794219|Drug|oral naproxen|750 mg/day oral naproxen is administered for 10 days.
15881388|NCT03794206|Device|Vesair Balloon|Treatment with Vesair Balloon for one year
15881389|NCT03794193|Procedure|Radical resection of colon cancer|The patients with colon cancer will receive radical surgery. Adjuvant chemotherapy will be given according to the results of postoperative histological results.
15881390|NCT03794180|Drug|TJ003234|Brownish-yellow liquid containing TJ003234, a recombinant humanized immunoglobulin (Ig) G1 monoclonal antibody diluted with normal saline
15881391|NCT03794180|Drug|Placebo|Colorless to slightly brownish-yellow liquid without TJ003234 diluted with normal saline
15881392|NCT03794167|Drug|Busulfan|busulfan 3.2 mg/kg/day i.v. on days -8,-7, and -6
15881393|NCT03794167|Drug|Cyclophosphamide|cyclophosphamide 50mg/kg/day i.v. on days -3 and -2
15881394|NCT03794167|Drug|Etoposide|etoposide 400mg/m2 day i.v. on days -5 and -4
15881395|NCT03794167|Drug|Melphalan|melphalan 50mg/m2/day i.v. on days -3 and -2
15881396|NCT03794154|Drug|Cymbalta capsule|Active Comparator: Cymbalta®- hard gelatinous capsule with delayed release microgranules ( Eli Lilly do Brasil Ltda) equivalent to 60 mg of duloxetine.
15881397|NCT03794154|Drug|Duloxetine hydrochloride capsule|Experimental Drug: Duloxetine hydrochloride - hard gelatinous capsule with delayed release microgranules (Pfizer S.R.L - Argentina.) equivalent to 60 mg of duloxetine.
15881398|NCT03794141|Behavioral|information on the risk gene status|information on risk gene status (APOE4 allele or not) was given before intervention
15881403|NCT03794102|Other|Water|Sterile water irrigation from standard sterile water bags will be used during ureteroscopy. Pulsed irrigation of the irrigant fluid with hand-held syringes will be used in all cases according to standard practice in order to visualize the upper urinary tract during the ureteroscopy procedure.
15881404|NCT03794102|Other|Saline|0.9% saline irrigation from standard saline bags will be used during ureteroscopy. Pulsed irrigation of the irrigant fluid with hand-held syringes will be used in all cases according to standard practice in order to visualize the upper urinary tract during the ureteroscopy procedure.
15881405|NCT03794089|Behavioral|Brief anxiety intervention|Modular anxiety intervention, tailored for Veterans, with emphasis on healthy active coping skills
15881406|NCT03794089|Behavioral|Usual PC-MHI care|Anxiety treatment with mental health provider in local primary care clinic
15881407|NCT03794076|Drug|Cromoglycate|Cromoglycate will be administered intranasally (nasal spray) (1 spray each nostril 4 times a day, 5.2 mg/spray
15881408|NCT03794076|Drug|Placebo|Normal saline nasal spray will be administered intranasally (nasal spray) (1 spray each nostril 4 times a day, 5.2 mg/spray)
15881409|NCT03794063|Other|Robson 10 group classification system|WHO proposed the Robson classification system as a global standard for assessing, monitoring and comparing caesarean section rates within healthcare facilities over time, and between facilities. It classifies women in 10 groups based on their obstetric characteristics (parity, previous CS, gestational age, onset of labour, fetal presentation and number of fetuses) without needing the indication for CS.
15881410|NCT03794050|Other|Resistance training exercise|randomized complete crossover for acute resistance training exercise session
15881411|NCT03794050|Other|Aerobic training exercise|randomized complete crossover for acute aerobic exercise training exercise session
15881412|NCT03794037|Drug|dydrgesterone 10 mg( tab)/12hs/14 days|Dydrogesterone Oral Tablet 10 mg twice daily for 14 days to be taken from the day of ovum pickup
15881413|NCT03794037|Combination Product|montelukast 10 mg(tab) oral/24hs/ 7 days dydrgesterone 10 mg( tab) oral/12hs/14 days|montelukast 10 mg(tab) once daily oral for 7 days & dydrgesterone 10 mg (tab) twice daily oral for 14 days &
15881414|NCT03794024|Device|The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator|The Nuvectra Algovita Dorsal Column Spinal Cord Stimulator is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.
15881415|NCT03794024|Device|The Axium Neurostimulator System|The Axium Neurostimulator System is indicated for spinal column stimulation via epidural and intra-spinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable pain of the lower limbs in adult patients with Complex Regional Pain Syndrome Types I and II
15881416|NCT03794011|Device|fetoscopy|The fetoscopic arm is described above. Patients who have an appropriate window (posterior placenta) and choose fetoscopic surgery will be offered the two fetoscopic options, (i) laparotomy assisted and, (ii) totally percutaneous expandable port assisted. Patients with an anterior placenta will only be offered the lapartotomy assisted approach. All patients will undergo a fetoscopic repair of the fetal open neural tube defect including a the use of a Durepair patch.
15881417|NCT03793985|Drug|T|CKD-391 40/10mg
15881418|NCT03793985|Drug|R|D086 and D337 co-administration
15881419|NCT03793972|Other|Triage with referral to primary care|During intervention weekends(and holidays) a nurse will triage patients using a newly developped extended Manchester Triage System (eMTS). Patients appropriate for primary care will be referred to the general practitioner on call.We will inform patients about the nature of the intervention using leaflets and broadcasting in the waiting room of the Emergency Department.
15881420|NCT03793972|Other|Usual care|During a control weekend (and holidays), all data registration and collection will be the same as during intervention weekends but patents will not be informed about their allocation advice. The emergency physician will see all patients deciding to stay at the ED, without influence of the triage advice. As in standard clinical care, patients will have the right to change their mind and go spontaneously to the general practitioner. . During control weekends, we will only inform about triage in general but no about the general practioner or the intervention.
15881421|NCT03793959|Dietary Supplement|Synbiotic Supplement|
15881422|NCT03793959|Dietary Supplement|Placebo|
15881423|NCT03793946|Other|AB-assistant|The AB-assistant is an antimicrobial stewardship smartphone application that offers local antimicrobial guidelines to physicians currently assessed per website or paper/digital booklet.
15881424|NCT03793933|Procedure|Liver resection|Surgery for the liver
15881425|NCT03793920|Other|Facial Emotion Test|All tasks will be delivered using a laptop and E-Prime 2 software (Psychology Software Tools, Inc., Pittsburgh), which will also be used to collect behavioral responses.
15881426|NCT03793907|Device|FitBit|Wear Fitbit
15881427|NCT03793907|Other|Quality-of-Life Assessment|Ancillary studies
15881428|NCT03793907|Other|Questionnaire Administration|Ancillary studies
15881429|NCT03793907|Other|Resistance Training|Complete strength training
15881430|NCT03793907|Behavioral|STEPS to Enhance Physical Activity|Complete a walking program
15881431|NCT03793894|Behavioral|Smoking Cessation Counseling|All participants will receive inpatient smoking cessation counseling by the tobacco-trained NP. Inpatient smoking cessation counseling is the standard of care at BMC.
15881432|NCT03793894|Behavioral|Decision Aid|"The AHRQ Is Lung Cancer Screening Right for me? patient decision aid is a 4-page paper format with the following features: 1) LDCT screening harms and benefits information, written in plain language and using pictographs, easily understood by those with low health literacy; 2) prompts to clarify patient values and preferences and to stimulate discussion about tradeoffs; 3) clear quit smoking messaging and resources (1-800-QUIT-NOW)"
15881433|NCT03793894|Behavioral|Shared decision making (SDM)|"During the smoking cessation consultation, the nurse practitioner (NP) will conduct SDM, using the 4-page AHRQ Is Lung Cancer Screening Right for me? decision aid as a guide. The purpose of SDM is three-fold: 1) conduct a tailored discussion on tradeoffs of LDCT screening, consistent with Centers for Medicare & Medicaid Services (CMS) requirements for SDM using a decision aid; 2) directly connect interested patients to LDCT screening; 3) to empower and motivate patients to quit smoking within the LDCT screening context."
15881546|NCT03792997|Combination Product|combination therapy for high peripheral NK cells|lipid emulsion & prednisolone & LMWH
15881434|NCT03793894|Behavioral|CHW Navigation|The CHW will meet with the participant after the SDM to initiate the coordination of outpatient tobacco treatment, referral to LCS, and resources to address the barriers to preventive services. The CHW will follow patients subjects in the intervention arm for 3 months to help navigate and address negative social determinants of health that are barriers to LCS and tobacco treatment. For patients who agree to screening, the CHW will schedule the appointment, arrange the transportation to appointment, and meet participant at the appointment to facilitate the screening.
15881435|NCT03793881|Behavioral|Nutritional Strategy|Counseling based on dietary goals and mindfulness techniques.
15881436|NCT03793881|Behavioral|Dietary Prescription|Dietary prescription according to guidelines.
15881437|NCT03793868|Drug|Perampanel|Oral tablet
15881438|NCT03793868|Other|Placebo|Placebo (not drug)
15881439|NCT03793855|Behavioral|Nutritional Strategy|Counseling based on dietary goals and mindfulness techniques.
15881440|NCT03793855|Behavioral|Dietary Prescription|Dietary prescription according to guidelines.
15881441|NCT03793842|Other|Usual care|Intervention is the standard basic lung protective ventilation strategy used at the University Hospital Respiratory Care at Michigan Medicine.
15881442|NCT03793842|Device|PEEP titration by EIT|PEEP Titration procedure involves two phases: a recruitment phase followed by a gradual reduction in the end-expiratory pressure phase (Decremental PEEP).
15881443|NCT03793829|Biological|(H2NVAC)|"Intervention: Biological/Vaccine: (H2NVAC) Dose levels: In phase I, there are 3 dose levels of H2NVAC Nine patients will be treated in each dose level starting dose level 1. a total of 27 patients will be enrolled in this phase.
~Dose Levels H2NVAC Dose 1.500 µg/peptide 2.1000 µg/peptide 3.1500 µg/peptide
~The dose with acceptable safety and tolerability & maximum immune response will be used in the expansion cohort of this trial. A total of 16 additional patients will be enrolled in this portion of this trial.
~Dose limiting toxicities (DLT) are defined to be any of the following criteria using the National Cancer Institute's Cancer Therapy Evaluation Program (CTEP) Common Terminology Criteria for Adverse Events, version 4.0"
15881444|NCT03793816|Device|BiZactTM Open Sealer/Divider|The BiZactTM Open Sealer/Divider creates a seal by application of radiofrequency (RF) electrosurgical energy to blood and lymphatic vessels or tissue bundles interposed between the jaws of the instrument. A cutting blade within the instrument is surgeon-activated to divide tissue. It is a single-use device and will not be reused in other patients.
15881445|NCT03793803|Behavioral|Home Palliative Care|Patients/caregivers will be cared for by an interdisciplinary team that includes a social worker, nurse, community health worker, nurse practitioner, and physician.
15881446|NCT03793790|Behavioral|Conditioning with partial reinforcement|Conditioning with partial reinforcement (PRF) provides an uncertain pairing of unconditioned high pain stimuli and conditioned stimuli (i.e., on-screen messages signaling the activation of a mock medical device). During PRF only 70 percent of unconditioned stimuli are paired to conditioned stimuli. Pain of only moderate intensity is used for control stimuli that are paired to the deactivation of the mock device and are also used in the 30 percent of unreinforced trials.
15881447|NCT03793790|Behavioral|Conditioning with continuous reinforcement|During conditioning with continuous reinforcement (CRF) unconditioned high pain stimuli are paired to conditioned stimuli (i.e., on-screen messages signaling the activation of a mock medical device) in 100 percent of conditioning trials. Pain of only moderate intensity is used for control stimuli that are paired to the deactivation of the mock device.
15881448|NCT03793790|Behavioral|Counterconditioning|During counterconditioning, the previously conditioned nocebo effects on pain are attenuated by pairing the same conditioned stimuli (i.e., on-screen messages signaling the activation of a mock medical device) to thermal pain stimuli of low intensity.
15881449|NCT03793790|Behavioral|Extinction|During extinction, the previously conditioned nocebo effects on pain are attenuated by pairing the same conditioned stimuli (i.e., on-screen messages signaling the activation of a mock medical device) only to control stimuli of moderate intensity (previously paired to the deactivation of the mock device).
15881450|NCT03793790|Behavioral|Sham Conditioning|In the sham group, participants receive different instructions (namely, that the activation of the device is not expected to affect their pain sensitivity). Additionally, during sham conditioning unconditioned stimuli are not consistently paired to conditioned stimuli, thereby preventing the formation of an association between high pain stimuli and the activation of the mock medical device. In the attenuation phase participants undergo an extinction procedure.
15881451|NCT03793777|Dietary Supplement|Aronia|daily supplementation
15881452|NCT03793777|Dietary Supplement|Placebo|daily supplementation
15881453|NCT03793764|Procedure|TAP block|USG guided TAP block
15881454|NCT03793764|Procedure|QL block|USG guided QL block
15881455|NCT03793751|Drug|Dexmedetomidine Injection|Dexmedetomidine Injection at a dose of 1 mcg/kg over 10 min, after Spinal Anaesthesia and before start of surgery, followed by a continuous infusion at a rate of 0.4 mcg/kg/h until the end of surgery.
15881456|NCT03793738|Procedure|Anterior component separation|
15881457|NCT03793738|Procedure|Posterior component separation|
15881458|NCT03793725|Drug|SHR1210|Anti-PD-1 Antibody
15881459|NCT03793725|Drug|Apatinib|Anti-angiogenic drugs
15881460|NCT03793712|Drug|Lu AF11167 (1-2 mg/day)|Fixed-flexible oral dose, tablets. Once daily. 12 weeks.
15881461|NCT03793712|Drug|Lu AF11167 (3-4 mg/day)|Fixed-flexible oral dose, tablets. Once daily. 12 weeks.
15881462|NCT03793712|Drug|Placebo|Placebo oral dose, tablets. Once daily. 12 weeks.
15881463|NCT03793686|Drug|PBCLN-003|Investigational drug
15881464|NCT03793686|Drug|Placebo|Placebo
15881465|NCT03793673|Behavioral|CoYoT1 Care|Selected providers will be trained in the CoYoT1 Care protocol for completing medical appointments (both telehealth/standard appointments). There are three key components: (1) Shared decision making: Providers and YA will mutually agree on priorities for each medical visit using a shared decision making tool completed by both the provider and patient. (2) Autonomy supportive care: Providers will be trained in communication strategies, such as motivational interviewing, designed to support YA autonomy and intrinsic motivation. YA will also direct extent of eligible family involvement. (3) Goal setting and action planning: Providers will be trained to coach YA in setting SMART goals, developing action plans, and establishing a plan for follow-up between visits as appropriate.
15881547|NCT03792984|Dietary Supplement|Vitamin D3|Vitamin D3 (Cholecalciferol) (6000 IU/daily). PO for 8 weeks.
15881466|NCT03793673|Other|Standard Care|"Providers selected for the Standard Care group will complete medical appointments in their usual manner, without specific training or guidelines regarding how to deliver care.
~NOTE: Per COVID-19 hospital policies, current clinic appointments consist of telehealth appointments."
15881467|NCT03793647|Device|Electrical muscle devise|evaluate two types of EMS stimulation of legs
15881468|NCT03793634|Drug|topical chamomile|herbal medication which has antioxidant, anti-inflammatory and anticarcinogenesis effect
15881469|NCT03793621|Drug|BI 730357|single rising oral dose
15881470|NCT03793621|Drug|Placebo|single rising oral dose
15881471|NCT03793608|Drug|Dupilumab|Dupilumab weight-based dosing will be administered subcutaneously (SC) in a single-use, pre-filled syringe every two weeks (Q2W)
15881472|NCT03793595|Device|Seated Battle Ropes Protocol|Participants will begin swinging the rope as previously described in the seated position using the double arm swing technique for 15 seconds at a cadence of 100 beats/ minutes with a 45 second rest break repeated 10 times.
15881473|NCT03793595|Device|Seated Upper Extremity Arm Bike|A modified Young Men's Christian Association (YMCA) cycle test will be performed.
15881474|NCT03793582|Diagnostic Test|ApneaLink Type III portable sleep study|Type III portable sleep study
15881475|NCT03793569|Behavioral|Peer discussion group|Subjects in the intervention group will be asked to attend one peer group between four and eight weeks postpartum. Peer groups will be expected to last approximately one hour. Each peer group will include 5-10 new mothers. A facilitator will be present for these groups, but the hope is to have mothers discuss with each other their postpartum experience and activities of their newborn at home.
15881476|NCT03793556|Device|GERDOFF® + Omeprazole|GERDOFF® Hyaluronic acid + chondroitin sulphate + hydroxide aluminium Melt-in-mouth tablet 1100 mg + Omeprazole was orally administered once a day before breakfast (2 capsules). The treatment lasted 6 weeks (+/- 2 days).
15881477|NCT03793556|Drug|Omeprazole|Omeprazole, 2 capsules 20 mg, once a day before breakfast
15881478|NCT03793543|Drug|18F-DCFPyL Injection|A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL
15881479|NCT03793530|Other|Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration|Transforaminal lumbar interbody fusion with local bone graft and intraoperative bone marrow concentration
15881480|NCT03793530|Other|Transforaminal lumbar interbody fusion with local bone graft|Transforaminal lumbar interbody fusion with local bone graft
15881481|NCT03793517|Drug|Decitabine|Decitabine 200mg.m-2.d-1 intervanously on days -12 and -11
15881482|NCT03793517|Drug|mBU/CY and ATG|Ara-C 4 g·m-2·d-1 intravenously on days -10 to -9 Busulfan (BU 3.2 mg·kg-1·d-1) intravenously on days -8 to -6, Cyclophosphamide (CY 1.8 g·m-2·d-1) intravenously on days -5 to -4 Simustine (Me-CCNU, 250 mg·m-2) orally once on day -3 ATG (2.5 mg·kg-1·d-1) intravenously on days -5 to -2
15881483|NCT03793517|Drug|mBU/CY|hydroxycarbamide (80 mg·kg-1) orally on day -10 Ara-C (2 g·m-2·d-1) on day -9 Busulfan (BU 3.2 mg·kg-1·d-1) intravenously on days -8 to -6, Cyclophosphamide (CY 1.8 g·m-2·d-1) intravenously on days -5 to -4 Simustine (Me-CCNU, 250 mg·m-2) orally once on day -3
15881484|NCT03793491|Other|TCI scale|TCI scale : Evaluation of the patient's personality with the TCI before that the treatment by continuous infusion started.
15881485|NCT03793491|Other|PDQ-39 scale|PDQ-39 scale: Comparison of life quality before and after the starting of he treatment by continuous infusion.
15881486|NCT03793478|Drug|Quizartinib|Administered orally once daily starting on Day 6 and continuing through Day 28
15881487|NCT03793478|Drug|Intrathecal (IT) triple chemotherapy prophylaxis|IT cytarabine, methotrexate, and either prednisolone or hydrocortisone; doses are based on the participant's age and standard practice at each site
15881488|NCT03793478|Drug|Fludarabine|30 mg/m^2/day IV infusion given over 30 minutes on Days 1 through 5 (administered based on body weight)
15881489|NCT03793478|Drug|Cytarabine|2000 mg/m^2/day IV infusion given over 3 hours on Days 1 through 5 (begin 4 hours after the start of fludarabine) (administered in accordance with standard of care) or 500 mg/m^2/day as a continuous 96-hour IV infusion on Days 1 through (administered based on body weight as optional high intensity consolidation therapy).
15881490|NCT03793478|Drug|Etoposide|100 mg/m^2/dose once daily as an IV infusion over 3 hours on Days 1 through 5 (administered based on body weight as optional high intensity consolidation therapy)
15881492|NCT03793439|Drug|Tofacitinib 5mg Oral Tablet [Xeljanz] 16 week trial|Tofacitinib 5mg oral table twice daily for 16 weeks
15881493|NCT03793439|Diagnostic Test|Spirometry|Spirometry testing at baseline, week 4, week 8, week 12, and week 16
15881494|NCT03793439|Genetic|RNA Sequencing|RNA sequencing test at baseline and week 16
15881495|NCT03793439|Diagnostic Test|Laboratory testing|Laboratory testing at baseline and weeks 2, 4, 8, 12 and 16
15881496|NCT03793439|Drug|Corticosteroid|Taper corticosteroids starting at week 4
15881497|NCT03793439|Drug|Tofacitinib 5mg [Xeljanz] 1 year open-label extension|After 16 weeks, subjects who meet the primary end-point will be permitted an optional one year open-label extension.
15881498|NCT03793426|Biological|Fibryga|Human plasma-derived fibrinogen concentrate
15881499|NCT03793413|Procedure|Lingual frenotomy|A lingual frenotomy will be performed using a CO2 laser - using the NFANT bottle feeding system, the intervention arm will be compared against the observation arm to determine if there are changes in lingual mobility parameters during bottle feeding.
15881500|NCT03793400|Drug|Bevacizumab Injection|Anti-vascular endothelial growth factor (VEGF)
15881501|NCT03793387|Procedure|AF-guided endobronchial marking|Bronchoscopic dye marking under CBCT-augmented fluoroscopic guidance
15881502|NCT03793387|Device|ENB-guided endobronchial marking|Bronchoscopic dye marking with ENB system
15881542|NCT03793036|Dietary Supplement|preoperative nutrition|The participants of experimental group received 400 mil of a clear carbohydrate drink (12,5 gr/100 mil carbohydrate, 50 kcal/100ml, pH 5.0) at 10:00 pm the evening before surgery and another 200 mil of the carbohydrate drink on the day of surgery, 2 hours before induction of anesthesia. After surgery the participants fasted until the recovery of function of the bowel.
15881543|NCT03793023|Drug|Teneligliptin 20mg|
15881544|NCT03793010|Drug|FX006|Single Intra-articular injection
15881545|NCT03793010|Drug|Normal saline|Single Intra-articular injection
15881503|NCT03793374|Other|Subcutaneous apocrine glands shaving|A 0.5-cm long incision was made in the identified elliptical surgical area at each axilla for the access of arthroscopy to remove the apocrine glands. A suction-assisted cartilage shaver (E9005 System, Linvatec Corporation, Largo, Florida, USA) was introduced through the incisions to remove of the subcutaneous apocrine glands radially. After defatting, the incisions were closed primarily with 4-0 polyglactin. We anchored the defatting skin to the axillary fascia by 4-0 nylon sutures instead of the tie-over dressing or tissue glues, and we also made several drainage holes by inserting an 18G needle obliquely into the defatting skin. Therefore, draining tubes were no longer needed. We will remove the stiches at the 8th day after the operation.
15881504|NCT03793361|Drug|Regorafenib|"Oral Drug in the form of 40 mg tablets - Regorafenib (120 mg/d) once daily for 3 weeks on / 1 week off plus Best Supportive Care (BSC) until progression (according to RECIST 1.1), intolerance or consent withdrawal.
~Provided by BAYER"
15881505|NCT03793361|Drug|Placebo|"Oral tablets - Placebo plus BSC until progression (according to RECIST 1.1) or unacceptable toxicity. Patients who have received placebo may be offered open-label regorafenib (cross-over option) after objective tumor progression
~Provided by BAYER"
15881506|NCT03793348|Device|MCD|Micro coring skin removal with automated coring device
15881507|NCT03793322|Drug|Indocyanine-Green(ICG)|ICG was administered intravenously 24 hours before the operation , or directly into the portal vein branches supplying the tumor-bearing hepatic segment, after puncturing of the target segments under intraoperative ultrasonography guidance.
15881508|NCT03793309|Drug|Vitamin D|Oral vitamin D
15881509|NCT03793296|Device|Percutaneous Device Closure: Vascular plug|percutaneous transcatheter approach into cardiac valve
15881510|NCT03793283|Device|CSII|Currently receiving CSII therapy during 6 or more months.
15881511|NCT03793283|Drug|Multiple dose insulin injections|Currently receiving MDI therapy during 6 or more months.
15881512|NCT03793270|Diagnostic Test|for patients and healthy donors|"Detection of (CD19, CD24, CD38 & CD27) markers in peripheral blood samples by Flow Cytometry
~Determine the serum level of IL 10 using ELISA plate"
15881513|NCT03793244|Dietary Supplement|TARGET protocol EN 1.5 kcal/mL|Enteral nutrition
15881514|NCT03793231|Combination Product|fungalAi platform technology|Electronic surveillance and radiologic diagnosis of invasive fungal infections using fungalAi and associated methodologies.
15881515|NCT03793218|Device|Latera Device|"This study seeks to compare a gold standard functional rhinoplasty maneuver, the alar batten graft, to the LATERA implant"
15881516|NCT03793218|Procedure|Alar Batten Graft|"This study seeks to compare a gold standard functional rhinoplasty maneuver, the alar batten graft, to the LATERA implant"
15881517|NCT03793205|Drug|Long-acting G-CSF|Long-acting G-CSF will be given 48 hours after the chemotherapy. A supplement of short-acting G-CSF will be given as required.
15881518|NCT03793205|Drug|Short-acting G-CSF|Short-acting G-CSF will be given as required 24 hours after the chemotherapy.
15881519|NCT03793192|Other|PACE2 Intervention|Written educational materials regarding physical activity, telephone-based coaching to integrate physical activity in daily life activities and address barriers to attending pulmonary rehabilitation.
15881528|NCT03793153|Procedure|Uterine Cooling Technique|Standard LSCS will be done except immediatelyfollowing delivery of the fetus the uterus will beexternalized in the usual fashion and the body of theuterus cephalad to the hysterotomy incision will bewrapped in sterile surgical towels saturated in sterile,iced normal saline. These towels will come from asterile cooling pot set to 30 degrees Fahrenheit. Theskin of the abdomen will be draped to prevent contactwith the cold towels. Iced saline-soaked towels will bekept in place for a minimum of 5 minutes and replacedat the discretion of the attending obstetrician until thehysterotomy is closed and the uterus is replaced intothe patient's abdomen.
15881529|NCT03793140|Drug|CPI-613|CPI-613 [2,500 mg/m2/day IV] over 2 hours (+/- 10 mins) Induction tx: Cycle 1 and 2: Treatment on Days 1-5 (Each cycle is 14 days). (Each Cycle is 14 days) Maintenance tx: All subsequent Cycles: Treatment with CPI-613 [2,500 mg/m2/day IV] over 2 hours (+/- 10 mins) on Days 1-5 (Each Cycle is 21 days)
15881530|NCT03793127|Other|Maximal oxygen consumption (V02 max)|Aerobic fitness will be determined by measuring V02 max during a stationary bicycle exercise test.
15881531|NCT03793127|Other|Brown adipose tissue (BAT) imaging|Brown adipose tissue will be differentiated from white adipose tissue using fat fraction and T2* relaxation time maps generated from a commercially available modified 6-point Dixon (mDixon) water-fat separation method.
15881532|NCT03793127|Other|Muscle function testing|This test will be done on a machine called a Biodex. We will measure the speed at which subjects move resistance at different percentages of their peak strength.
15881533|NCT03793114|Diagnostic Test|Cosyntropin stimulation test|Blood samples are taken before (0 min), and 30 and 60 min after intravenously administration of 250 µg cosyntropin (tetracosactide acetate) with the patient placed in the recumbent position. The test will be performed non-fasting (but medication-fasting) between 08:00 and 10:00 a.m.
15881534|NCT03793114|Diagnostic Test|Baseline blood tests|Medication-fasting morning levels of adrenocortical hormones.
15881535|NCT03793114|Device|30-hour ambulatory sampling of intestinal fluid|30-hour ambulatory sampling of intestinal fluid for analysis of adrenocortical hormones.
15881536|NCT03793114|Other|Blood test|Cardiovascular and inflammatory biomarker profiles
15881537|NCT03793101|Procedure|BiMICS|Biaxial microincision cataract surgery implies performing of 2 corneal incisions under 1.8mm, removal of the crystalline lens with the use of ultrasounds and implantation of the artificial intraocular lens.
15881538|NCT03793075|Drug|Ketamine|ketamine 5 mcg/kg/min will be used as intravenous anesthetic infusion
15881539|NCT03793075|Drug|Propofol|propofol 17 mcg /kg/min
15881540|NCT03793062|Other|No Interventions|Not applicable - No Interventions
15881541|NCT03793049|Device|CADence testing will be performed|CADence is a noninvasive, handheld device comprised of acoustic and ECG technology and software
15881549|NCT03792984|Drug|Metformin|Metformin (1500 mg/daily; the metformin dose was increased stepwise, starting with 500 mg once daily for the 1st week, 500 mg twice daily in the 2nd week, followed by 500 mg 3 times daily from the 3rd week onward). PO for 8 weeks.
15881550|NCT03792984|Drug|Placebo|PO for 8 weeks.
15881551|NCT03792971|Drug|Dextromethorphan HBr|A single 60 mg dose of DM capsules liquid-filled on Day 1 and Day 3
15881552|NCT03792971|Drug|GC4419|Daily 90 mg IV infusions over 60 minutes on Day 3 and Day 4
15881553|NCT03792958|Drug|CM082|CM082 tablets taken orally 200、400、600 and 800 mg (QD or BID)
15881554|NCT03792945|Drug|local injection|In addition to the local injection, carpal tunnel brace will be given.
15881555|NCT03792945|Device|extracorporeal shock wave therapy|In addition to all ESWT participants, carpal tunnel brace will be given.
15881556|NCT03792932|Procedure|Laparoscopic distal pancreatectomy|Laparoscopic distal pancreatectomy includes distal pancreatectomy, splenectomy, and regional lymph nodes resection for pancreatic cancer at the body and tail. Regional lymph nodes includes group 8, 10, 11, 18, 7, 9, 14, 15, according to the 2003 edition of lymph nodes group system defined by Japan Pancreas Society (JPS).
15881557|NCT03792932|Procedure|Open distal pancreatectomy|Open distal pancreatectomy includes distal pancreatectomy, splenectomy, and regional lymph nodes resection for pancreatic cancer at the body and tail. Regional lymph nodes includes group 8, 10, 11, 18, 7, 9, 14, 15, according to the 2003 edition of lymph nodes group system defined by Japan Pancreas Society (JPS).
15881558|NCT03792919|Drug|Stop current treatment (anti-HBV neucleos(t)ides)|Stop the current anti-HBV neucleos(t)ides treatment among the CHB patients who meet the criteria the stopping rule of long term treatment.
15881559|NCT03792919|Drug|Keep current treatment (anti-HBV neucleos(t)ides)|Keep the current anti-HBV neucleos(t)ides treatment among the CHB patients who meet the criteria the stopping rule of long term treatment.
15881560|NCT03792906|Drug|Norepinephrine 6 mcg|An intravenous bolus of norepinephrine 6 mcg will be administered for management of maternal hypotension.
15881561|NCT03792906|Drug|Norepinephrine 10 mcg|An intravenous bolus of norepinephrine 10 mcg will be administered for management of maternal hypotension.
15881562|NCT03792906|Drug|Norepinephrine infusion|Prophylactic norepinephrine infusion will be started after subarachnoid block.
15881563|NCT03792906|Drug|Bupivacaine hydrochloride|Subarachnoid block will be performed using Bupivacaine hydrochloride (2.2 mL) in addition to fentanyl 25 mcg.
15881564|NCT03792893|Other|Ergometry H|"After a pre-rest period of 12 minutes, the subjects are physically strained on the ergometer for 48 minutes (6 minutes loading phase followed by a 2-minute rest phase; 30 watts increase every 8 minutes up to a maximum load of 180 watts), followed by a 12-minute rest periodmaximum load of 180 watts), followed by a 15-minute post-rest period.
~BOSO-TM-2430 blood pressure cuff is applied to the upper arm with the previously determined higher systolic blood pressure (reference parameter).
~SOMNOtouchTM RESP and GeTeMed Vitaguard 3100 are accordingly applied to the arm with the previously determined lower systolic blood pressure."
15881565|NCT03792893|Other|Ergometry L|"After a pre-rest period of 12 minutes, the subjects are physically strained on the ergometer for 48 minutes (6 minutes loading phase followed by a 2-minute rest phase; 30 watts increase every 8 minutes up to a maximum load of 180 watts), followed by a 12-minute rest periodmaximum load of 180 watts), followed by a 15-minute post-rest period.
~BOSO-TM-2430 blood pressure cuff is applied to the upper arm with the previously determined lower systolic blood pressure (reference parameter).
~SOMNOtouchTM RESP and GeTeMed Vitaguard 3100 are accordingly applied to the arm with the previously determined higher systolic blood pressure."
15881566|NCT03792880|Behavioral|Telematic control and self-management program|"During 6 months with CPAP treatment, patients must complete some questionnaires about the presence of refreshing sleep and side effects with the frequency established, using a computing application. Patients can download this application on their own smartphone but, if they prefer, they can be provided with a tablet during the study with this application installed.
~A set of variables will be collected using an automatic and wireless transmission from latest generation CPAP to control the CPAP compliance and tolerance. All data will be processed in a platform to generate alarms, which will be controled daily by a researcher, as well as solutions to the problems presented during the monitoring."
15881567|NCT03792880|Behavioral|Habitual follow-up in Healthcare System|According to the SEPAR regulation, patients treated with CPAP should be evaluated by the pulmonologist one month after beginning treatment, every 3 months during the first year, every 6 months during the second year and annually from the third year.
15881568|NCT03792867|Drug|Doxorubicin|Immediately after resection, 15mg/m2 doxorubicin will be administered by peritoneal perfusion for 60 minutes and then drained.
15881569|NCT03792854|Other|EORTC QLQ C30|standardized questionaire
15881570|NCT03792854|Other|EORTC QLQ CR29|standardized questionaire
15881571|NCT03792841|Drug|acapatamab|Investigational immunotherapy for the treatment of metastatic castration-resistant prostate cancer
15881572|NCT03792841|Drug|Pembrolizumab|Combined with acapatamab for investigational treatment of mCRPC
15881573|NCT03792841|Drug|Etanercept|Prophylaxis for acapatamab-related cytokine release syndrome.
15881574|NCT03792841|Drug|Cytochrome P450 (CYP) Cocktail|Evaluate the effect of co-administration of multiple dosing of acapatamab on plasma
15881575|NCT03792828|Drug|Duloxetine HCl 30mg|In the duloxetine group, one capsule of Duloxetine HCl 30mg (Duroceptol) is taken orally and daily from the day before the first operation to seven days after the second operation. In the control group, the patients can take painkillers except duloxetine.
15881576|NCT03792815|Drug|Busulfan|busulfan 3.2mg/kg iv on day -8, -7, and -6,
15881577|NCT03792815|Drug|Melphalan|melphalan 50mg/m2/day i.v. on day -3 and -2
15881578|NCT03792815|Drug|Etoposide|etoposide 400 mg/m2 i.v. on day -5 and -4
15881579|NCT03792802|Procedure|laparoscopic appendectomy port sites|one group will have classic port sites ;.Port sites located 1 infraumbilical , 1 right lower quadrant and 1 left lower quadrent . one group will have same dermatome port sites ; One of the port will put in infraumbilical site and the other ones will put 10 cm right and left side from infraumbilical port
15881615|NCT03792581|Device|EV1000 and closed-loop system|This system will recommend when patients need fluid or not and adjust vasopressor administration automatically
15881616|NCT03792568|Other|ALK Inhibitor|Any ALK inhibitor like crizotinib, alectinib and so on.
15881617|NCT03792555|Drug|Paltusotine|Paltusotine, capsules, once daily by mouth
15881580|NCT03792789|Device|mCIMT with real rTMS|"Modified constraint induced movement therapy will be provided to all children according to predefined protocol.
~rTMS will be provided using figure of eight shaped coil and TMS stimulator ((Magventure Denmark, X100 with mapoption) over contra-lesional primary motor cortex over 10 sessions of 20 minutes each spread over 4 weeks. Each session will comprise priming ( 10 minutes of 6Hz rTMS at 90% of resting motor threshold, delivered in two trains per minute with 5 seconds per train and 25-seconds intervals between trains (a total of 600 priming pulses)). Priming will be followed immediately by additional 10 minutes of 1Hz rTMS at 90% of resting motor threshold without interruption (a total of 600 low-frequency pulses)."
15881581|NCT03792789|Device|mCIMT with sham rTMS|"Modified constraint induced movement therapy will be provided to all children according to predefined protocol.
~Sham rTMS will be given using a sham coil."
15881582|NCT03792776|Other|cuff inflation with air|Endotracheal tube cuff inflation with air
15881583|NCT03792776|Drug|cuff inflation with lidocaine 1%|Endotracheal tube cuff inflation with lidocaine 1%
15881584|NCT03792776|Drug|cuff inflation with lidocaine 2%|Endotracheal tube cuff inflation with lidocaine 2%
15881585|NCT03792776|Other|Induction of anesthesia|The induction of anesthesia will be made following a preoxygenation with a facial mask with 100% Oxygen. It consists on the intravenous injection of Sufentanil 5 mcg or Fentanyl 50mcg, Lidocaine 1mg/Kg, Propofol 2.5mg/kg, Rocuronium 0.6mg/kg or Cisatracurium 0.15mg/kg.
15881586|NCT03792776|Other|Maintenance of anesthesia|Maintenance of anesthesia will be done by sevoflurane + nitrous oxide, and reinjections of morphinomimetics and curare will be made as needed (the total doses will be noted at the end of the intervention).
15881587|NCT03792776|Other|Endotracheal intubation|The intubation is made by a N° 7.5 tube in men and a N° 7 tube in women. Cuff inflation will be done upon placement of the endotracheal tube. The cuff's pressure will be monitored at several intervals of the intervention and kept < or = 20 centimeter of water (cmH2O).
15881588|NCT03792776|Other|Systematic post-operative analgesia|All patients will receive Paracetamol every 6 hours for the first 24 hours after the end of surgery.
15881589|NCT03792763|Drug|Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]|Administration every 4 weeks (Q4W) for 6 months then every 3 months (Q3M) for a total of 3 years or until progression to active, symptomatic MM
15881590|NCT03792763|Drug|Placebo 1.7 ml Subcutaneous Solution|Administration every 4 weeks (Q4W) for 6 months then every 3 months (Q3M) for a total of 3 years or until progression to active, symptomatic MM
15881593|NCT03792737|Device|Spiral PDS Plus|The Spiral PDS Plus is an antibacterial monofilament, synthetic absorbable device. It contains triclosan, a broad spectrum antibacterial agent. The device consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. Spiral PDS Plus barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.
15881594|NCT03792737|Device|Spiral MONOCRYL Plus|The Spiral MONOCRYL Plus is an antibacterial monofilament, synthetic absorbable device. It contains triclosan, a broad spectrum antibacterial agent. The device consists of barbed suture material, armed with a surgical needle on one end and a fixation loop at the opposite end. The device is designed to anchor with a closed loop at one end and a unidirectional barbed section on the other end. Spiral MONOCRYL Plus barbs are oriented in one direction to allow tissue approximation without the need to tie surgical knots.
15881595|NCT03792737|Device|PDS Plus|PDS Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent.
15881596|NCT03792737|Device|MONOCRYL Plus|MONOCRYL Plus is a non-barbed antibacterial monofilament, synthetic absorbable suture. The suture contains triclosan, a broad spectrum antibacterial agent.
15881597|NCT03792737|Device|VICRYL Plus|VICRYL Plus antibacterial suture is a non-barbed synthetic absorbable sterile, surgical suture. The suture contains triclosan, a broad spectrum antibacterial agent.
15881598|NCT03792724|Drug|Urelumab + Nivolumab|Treatment with intratumoral urelumab after which Nivolumab will be given.
15881599|NCT03792711|Dietary Supplement|Ensure® Plus Advance|"Previous studies suggest that protein supplementation is an effective dietary strategy to decrease frailty by positively influence the weight loss or sarcopenia in elderly.
~Lean body mass includes all body tissue except fat and is well recognized to be associated with an increased risk of morbidity and mortality. Oral nutrition supplements have been shown to increase food intake and body weight, but not lean body mass. In previous studies, β-hydroxy-β-methylbutyrate, which is leucine metabolite, has been shown to enhance protein synthesis and decrease protein degradation leading to increase lean body mass. It showed that β-hydroxy-β-methylbutyrate supplement with exercise increased lean body mass in health elderly population and improved the physical performance in elderly women."
15881600|NCT03792698|Other|Aidcube digital app-based platform|Use of customizable, patient-specific mHealth home rehabilitation plan
15881601|NCT03792685|Other|Normo-carbohydrate meal intake|Subjects are going to receive the normo-carbohydrate meal.
15881602|NCT03792685|Other|High-carbohydrate meal intake|Subjects are going to receive the high-carbohydrate meal.
15881603|NCT03792685|Other|High-fat meal intake|Subjects are going to receive the high-fat meal.
15881604|NCT03792685|Other|High-protein meal intake|Subjects are going to receive the high-protein meal.
15881605|NCT03792672|Drug|TAK-653|TAK-653 tablets.
15881606|NCT03792672|Drug|Placebo|TAK-653 placebo-matching tablets.
15881607|NCT03792672|Drug|Ketamine|Ketamine intravenous infusion.
15881608|NCT03792659|Other|Blood Sample Draw|Approximately 100 cc (less than 1/2 cup) of blood will be drawn from both groups.
15881609|NCT03792646|Dietary Supplement|Whey protein|Exercise training + 20g whey protein
15881610|NCT03792646|Other|Exercise training|Strength exercise
15881611|NCT03792633|Biological|huCART19|huCART19 infusion
15881612|NCT03792620|Combination Product|Cyclo Thal Dex Daratumumab|Cyclo Thal Dex Daratumumab
15881613|NCT03792594|Other|arthroscopic repair with bone marrow concentration|arthroscopic repair with bone marrow concentration
15881614|NCT03792594|Other|arthroscopic repair|arthroscopic repair only
15881618|NCT03792555|Drug|Placebo|Placebo, capsules, once daily by mouth
15881619|NCT03792542|Drug|Anlotinib|Anlotinib Hydrochloride ( 12mg, quaque die（QD）, PO, d1-14, 21 days per cycle), take once when limosis in the morning. If patients cannot suffer from adverse events(AEs), they can get declined dosage.
15881620|NCT03792529|Other|detect gene mutations of ctDNA and ctRNA|Samples were collected from patients at baseline, during therapy and after disease progression, and gene mutations of ctDNA and ctRNA were detected in the samples.
15881621|NCT03792516|Drug|artesunate ointment 40%|artesunate formulated as an ointment to be applied topically to the vulva
15881622|NCT03792503|Drug|Apatinib|Apatinib 500 mg Po qd
15881623|NCT03792503|Drug|Pemetrexed|Pemetrexe 500 mg/m2 d1×q3w
15881624|NCT03792490|Drug|Fasudil|Fasudil hydrochloride hydrate IV solution
15881625|NCT03792490|Drug|Placebo|Placebo to Fasudil hydrochloride hydrate, NaCl 0,9%
15881626|NCT03792477|Biological|Test formulation|A single testosterone cypionate solution for injection (new formulation) 200 mg dose administered IM deep in the gluteal muscle (Test formulation).
15881627|NCT03792477|Biological|Reference formulation|A single testosterone cypionate solution for injection (currently marketed formulation) 200 mg dose administered IM deep in the gluteal muscle (Reference formulation).
15881628|NCT03792451|Drug|Pegvaliase|Treated with pegvaliase for one or more years or followed an unrestricted diet for 6 or more months while being treated with pegvaliase.
15881629|NCT03792438|Diagnostic Test|Transvaginal 3D Power Doppler Ultrasound|Samsung H60 ultrasound machine with 4-9 MHz volume transducer using VOCAL system and Histogram Facility
15881630|NCT03792425|Procedure|Connective tissue graft and implant placement|Augmenting soft tissue with connective tissue graft
15881631|NCT03792412|Other|Usability Questionnaire|Patients receive the usability questionnaire and a structured nutrition and lifestyle program for post-bariatric follow-up visits. Twice in six months the patients visit their family doctor and hand over the usability questionnaire to evaluate the structured follow-up program for postbariatric patients. Family doctors fill out the questionnaire and returns it to the investigator.
15881632|NCT03792399|Behavioral|feedback counseling|Professoinal CGM in combination with diet and exercise record is used as teaching material to help patient realize their blood glucose pattern and to modify their behavior after counseling feedback.
15881633|NCT03792386|Procedure|Ultrasound guidance with fluoroscopic confirmation|the cervical spine will be sonographically examined to determine the C7 transverse process then after lidocaine skin infiltration, a 22G spinal needle is directed towards the hypoechoic shadow of the nerve root using the in-plane technique. then 1ml of non-ionic contrast will be injected and AP and the oblique foraminal fluoroscopic view will be obtained. After confirmation of correct placement of the needle,(2ml, 8mg dexamethasone plus 1ml Lidocaine 1%) will be injected.
15881634|NCT03792386|Procedure|Fluoroscopic guidance with ultrasonographic confirmation.|After AP view, alignment or squaring of the target lower end plate, an oblique foraminal view is obtained. Following lidocaine 1% skin infiltration, a 22G spinal needle is directed towards the target foramen then, the superficial ultrasound probe will be applied to delineate the foramen. The needle will be advanced ~3mm towards the dorsal root ganglia under fluoroscopic guidance. After contrast confirmation of needle placement, 2ml,8mg dexamethasone plus 1ml Lidocaine 1%) will be injected.
15881635|NCT03792360|Drug|SVF (Stromal Vascular Fraction)|The stromal vascular fraction (SVF), isolated when fresh lipoaspirates are enzymatically digested with a collagenase, contains a heterogeneous cellular and extracellular milieu. SVF is an aqueous fraction, consisting of endothelial cells and their precursors, macrophages, smooth muscle cells, lymphocytes, pericytes, pre-adipocytes and actual AMSCs.
15881636|NCT03792347|Drug|Pembrolizumab|Arm1：Pre-operative Pembrolizumab+chemoradiotherapy
15881637|NCT03792334|Device|depth of anesthesia|monitoring of depth of anesthesia
15881638|NCT03792321|Drug|Testosterone Undecanoate|1000 mg i.m. every 10 weeks
15881639|NCT03792321|Drug|Placebo|
15881640|NCT03792308|Drug|SPR206|"SAD Cohorts: Double-blind dosing will occur in Cohorts 1 - 8. Six participants will receive single doses of SPR206. The dose escalation steps may be altered following review of the safety data upon completion of each cohort.
~MAD Cohorts: Double blind dosing will occur in Cohorts 9 - 13. Six participants in each cohort will receive multiple doses of SPR206. The dose escalation steps may be altered following review of the safety data upon completion of each cohort. Dosing will commence on the morning of Day 1. Three doses will be administered per day at approximately 8 hours apart. Daily dosing will continue for a total of 7 consecutive days for Cohorts 9 - 12 and for a total of 14 consecutive days for Cohort 13."
15881641|NCT03792308|Drug|Placebo|0.9% sodium chloride for injection. SAD Cohorts: Two participants in each cohort will receive matching placebo. MAD Cohorts: Two participants in each cohort will receive matching placebo.
15881642|NCT03792295|Drug|acetominophen, ibuprofen, oxycodone|Multimodal pain treatment group
15881643|NCT03792295|Drug|Oxycodone|Classic opiod pain treatment group
15881644|NCT03792282|Behavioral|Time Restricted Feeding|Participants will receive a diet of 1200-1500kcal/d and be instructed to eat only during a window of 8 hours (Finishing the last meal before 4pm).
15881645|NCT03792282|Behavioral|Reduced Calorie Diet (RCD)|Participants will receive a diet of 1200-1500kcal/d and keep their usual eating pattern.
15881646|NCT03792269|Drug|Irinotecan|intraperitoneal
15881647|NCT03792269|Drug|Oxaliplatin|intravenous
15881648|NCT03792269|Drug|Capecitabine|
15881649|NCT03792256|Drug|Palbociclib|Given PO (or via NG- tube)
15881650|NCT03792256|Drug|Cytarabine|Given intrathecally (IT)
15881651|NCT03792256|Drug|Methotrexate|Given intrathecally (IT)
15881652|NCT03792256|Drug|Hydrocortisone|Given IT
15881653|NCT03792256|Drug|Doxorubicin|Given intravenously (IV)
15881654|NCT03792256|Drug|Prednisolone|Either prednisone or prednisolone is given PO
15881655|NCT03792256|Drug|Vincristine|Given IV
15881656|NCT03792256|Drug|Pegaspargase|Given IV
15881657|NCT03792256|Drug|Hydrocortisone|Given intrathecally (IT)
15881658|NCT03792256|Drug|Prednisone|Either prednisone or prednisolone is given PO
15881659|NCT03792243|Procedure|Complication|Readmission, reoperation
15881660|NCT03792230|Behavioral|Video|Video group receive body mechanic education via CD material,
15881661|NCT03792230|Behavioral|Brochure|Brochure group receive body mechanic education via written material (brochure)
15881662|NCT03792217|Other|1.3% NaOCl|Endodontic irrigant
15881664|NCT03792204|Diagnostic Test|Wearing-off 9 questionnaire|The participants would receive appropriate anti-PD medical treatments according to the patients' need during the investigation.The anti -PD treatment would not be changed in the population of the participants.
15881665|NCT03792191|Radiation|Lumbar Spinal Ultrasonography|Ultrasonography of the lumbar spines using an 8-2 MHz curved array transducer. Identification of the intervertebral space with the best image. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 intervertebral spaces.
15881666|NCT03792191|Radiation|Sham Ultrasound Procedure|Moving the ultrasound probe on the patient's back with the machine in the freeze position.
15881667|NCT03792191|Procedure|Conventional Landmark Palpation|Conventional palpation of the anatomical landmarks. The line crossing the iliac crests (Tuffier line) is assumed to cross the spine at L4 spinous process or L3-L4 intervertebral space. Identification of the widest intervertebral space. Marking the patient's skin with horizontal and vertical lines over the L3-L4 and L2-L3 intervertebral spaces.
15881668|NCT03792191|Procedure|Spinal Anesthesia|Spinal anesthesia using a 25- or 22-gauge spinal needle
15881669|NCT03792191|Drug|Intrathecal Bupivacaine|Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space
15881670|NCT03792191|Drug|Intrathecal Fentanyl|Fentanyl 15 μg will be administered in the subarachnoid space
15881671|NCT03792178|Other|Bulk fill composite|Composite resin dental material
15881672|NCT03792178|Other|Nano resin composite|Dental composite material
15881673|NCT03792165|Other|Action observation therapy|The normal human movement will be recorded and than the patients will be watched them.
15881674|NCT03792165|Other|Exercise|Strengthening and stretching exercise programme focuses on hip and knee muscles
15881675|NCT03792152|Drug|Rivaroxaban|After diagnosis of left atrial appendage thrombus by transesophageal echocardiography, then start with rivaroxaba 20mg qd (15mg If creatinine clearance is between 30-49 ml/min).
15881676|NCT03792152|Drug|Warfarin|After the diagnosis of left atrial appendage thrombus by transesophageal echocardiography, subcutaneous injection of low molecular weight heparin (4000iu q12h) and oral warfarin treatment were started, and low molecular weight heparin was stopped after INR reached 2.
15881677|NCT03792139|Drug|LY3200882|Administered orally.
15881678|NCT03792139|Drug|Itraconazole|Administered orally.
15881679|NCT03792126|Other|Implicit Learning Approach|"All mobility focussed rehabilitation sessions will utilise the Implicit Learning Approach (ILA), as usual care. This includes rehabilitation (delivered by a physiotherapist, occupational therapist or therapy assistant) that focusses on sitting, sit to stand, standing, stepping, transfers and walking. The content of therapy will be based on the treatment guidelines and intervention manual - and primarily involves changing the quantity and focus of attention of instructions and feedback.
~As this is a clinically grounded, pragmatic trial, therapists will have freedom to tailor the specific content of each treatment session to patient need, whilst remaining true to the ILA."
15881680|NCT03792113|Procedure|Periodontal Flap Surgery|Periodontal access flap surgery will be performed in both test site followed by control site in each subject
15881681|NCT03792113|Other|Autologous fibrin glue|Autologous fibrin glue procured from the subject's own venous blood will be used to approximate periodontal flaps following access periodontal surgery
15881682|NCT03792113|Other|4-0 silk suture|Conventional 4-0 black silk suture will be used to approximate periodontal flaps following access flap surgery
15881683|NCT03792100|Drug|SmofKabiven emulsion for infusion|Total Parenteral Nutrition
15881684|NCT03792100|Drug|"Hospital compounded All in one emulsion"|Total Parenteral Nutrition
15881685|NCT03792087|Drug|SmofKabiven Peripheral|Total Parenteral Nutrition
15881686|NCT03792087|Drug|Hospital compounded emulsion|Total Parenteral Nutrition
15881687|NCT03792074|Drug|SCT510|SCT510 Injection
15881688|NCT03792074|Drug|Bevacizumab|Bevacizumab Injection
15881689|NCT03792074|Drug|Paclitaxel|Paclitaxel Injection
15881690|NCT03792074|Drug|Carboplatin|Carboplatin injection
15881691|NCT03792061|Behavioral|Strategy Training|This approach is different from traditional direct skill training, which emphasizes clinicians' responsibility on identifying their patients' challenges in performing activities and teaching patients task-specific problem-solving strategies. Strategy training, on the other hand, requires clinicians to take a role as a facilitator, guiding participants to learn through prompts and questions. In the training process, participants learn to develop their own problem-solving strategies and work through the problems they have, through which they can develop self-efficacy and confidence to manage participation challenges. Participants can also generalize the strategies they learn to other similar problems they encounter in daily life.
15881692|NCT03792048|Procedure|Magnetic Compressive Anastomosis|A magnetic device will be used during bilioenteric anastomosis and pancreaticojejunostomy
15881693|NCT03792035|Drug|Tongxinluo|tid, po.
15881694|NCT03792035|Drug|Placebos|tid, po.
15881695|NCT03792022|Behavioral|Adherence to timely vaccine uptake|Adherence to timely vaccine uptake
15881696|NCT03792009|Device|Paracervical block|The paracervical injection with 10 mL of 0.5% bupivacaine plus 1:200,000 epinephrine or normal saline was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.
15881697|NCT03792009|Drug|5% bupivacaine|The paracervical injection with 10 mL of 0.5% bupivacaine plus 1:200,000 epinephrine was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.
15881698|NCT03792009|Drug|Normal saline|The paracervical injection with 10 mL of normal saline was administrated by the second assistant surgeon into the cervicovaginal junction at 3 and 9 o'clock with a depth of 1 cm after intubation but before fixation of uterine manipulator onto the cervix.
15881699|NCT03791996|Procedure|"Early cranioplasty"|Subjects undergoing cranioplasty beyond 3 months after craniectomy.
15881700|NCT03791983|Other|Scalp Acupuncture|Scalp acupuncture is a form of alternative medicine in which thin needles are inserted into the scalp. It is a key component of traditional Chinese medicine (TCM).
15881701|NCT03791983|Other|Body Acupenture|Acupuncture is a form of alternative medicine in which thin needles are inserted into the body. It is a key component of traditional Chinese medicine (TCM).
15891000|NCT03719469|Dietary Supplement|Green tea group|
15881702|NCT03791970|Device|Orchid 035 DCB Catheter|Stents placement for femoropopliteal arterial occlusions following with Orchid 035 DCB Catheter for post-dilation
15881703|NCT03791970|Device|POBA Catheter|Stents placement for femoropopliteal arterial occlusions following with POBA for post-dilation
15881704|NCT03791957|Other|Blood Haemoglobin|Routine haemotological investigation of blood haemoglobin levels in gm/dL will be recorded from withdrawn venous blood
15881705|NCT03791944|Device|3DV+TPS/VARIAN|Use imported 3DV+TPS to map targets and develop treatment plans
15881706|NCT03791944|Device|TPS / VARIAN|Use imported TPS to map targets and develop treatment plans
15881707|NCT03791944|Device|3DV + TPS / Domestic Accelerator|Use domestic 3DV+TPS to delineate target areas and develop treatment plans
15881708|NCT03791944|Device|TPS / Domestic Accelerator|Use domestic TPS to map targets and develop treatment plans
15881709|NCT03791931|Diagnostic Test|oxidative stress measurement|oxidative stress measurement
15881710|NCT03791918|Drug|Lenvatinib|12 mg (or 8 mg) once daily (QD) oral dosing.
15881711|NCT03791918|Drug|PD-1 antibody|3mg/kg intravenously every 2 weeks
15881712|NCT03791918|Procedure|TACE|A standard hepatic artery catheter was introduced via the femoral artery percutaneously. Selective catheterization of the proper hepatic artery was performed using standard diagnostic catheters and fluoroscopic guidance. TACE Drug Protocol were injected.
15881713|NCT03791918|Drug|TACE Drug Protocol|lipiodol mixed with chemotherapy drugs(EADM , lobaplatin, and MMC) followed by polyvinyl alcohol particles (PVA)
15881714|NCT03791905|Drug|Paclitaxel|chemotherapy drug
15881715|NCT03791905|Drug|Cisplatin|chemotherapy drug
15881716|NCT03791905|Drug|Oxaliplatin|chemotherapy drug
15881717|NCT03791905|Drug|5-FU|chemotherapy drug
15881718|NCT03791905|Drug|Leucovorin|chemotherapy drug
15881719|NCT03791905|Radiation|Intensity-modulated radiotherapy|radiotherapy technique
15881720|NCT03791905|Device|PET|Using PET to evaluate response to induction chemotherapy
15881721|NCT03791892|Other|Shoulder mobilization Group|Suprascapular nerve block administered every week to both groups. Joint mobilization (3 sets / 40 seconds hold / 30 seconds interval) Stretching exercises (3 sets / 30 seconds hold / 10 seconds interval) Strengthening exercises ( 3 sets / 15 reps)
15881722|NCT03791892|Other|Conventional Treatment Group|Suprascapular nerve block administered every week to both groups. Daily Stretching exercises (3 sets / 30 seconds hold / 10 seconds interval) Daily Strengthening exercises ( 3 sets / 15 reps)
15881723|NCT03791879|Drug|Caudal dexamedatomidine analgesia|"Technique performance (Caudal block): classical technique; palpation, identification and puncture with the patients in the lateral position (permits easy access to the airway under general anesthesia) using a 22-G short-beveled needle under sterile conditions advancing needle pierces the sacrococcygeal ligament.
~After needle insertion, pre-calculated volume of Levob plus DEXM bolus was injected as follow; Group A Caudal Levob 0.125%+ DEXM 0.5µg/kg. Group B Caudal Levob 0.125%+ DEXM 1µg/kg. Group C Caudal Levob 0.125%+ DEXM 1. 5 µg/kg. Group D Caudal Levob 0.125%+ DEXM 2µg/kg."
15881724|NCT03791866|Other|Nutrition|Enteral nutrition
15881725|NCT03791853|Diagnostic Test|Light-CT|Fresh specimen is trimmed into a block with a size not larger than 2.5 cm (Typically not larger than 1.5 cm). Prepared specimen is submitted to Light-CT tests. FF-OCT images are obtained to depict the structure information and DCI images are generated to collect the dynamic information of the cell and tissue. After the imaging detection, specimens are submitted for routine pathological diagnosis to obtain corresponding pathological images.
15881726|NCT03791840|Diagnostic Test|Ultrasound evaluation|High-frequency ultrasound is used to detected the lymph node metastasis in vivo and vitro. The lymph node number, morphology and elastographic parameters are collected in the patients and in fresh lymph node specimens.
15881727|NCT03791827|Drug|Corticosteroid|corticosteroid is given to patients orally or methylprednisone is given to patients through i.v.
15881728|NCT03791827|Drug|Hydroxychloroquine|Hydroxychloroquine is recommended as the basic therapy for lupus nephritis
15881729|NCT03791827|Drug|Cyclophosphamide|The typical therapy for cyclophosphamide is either 500 to 750mg/m2 once every month for 6 doses or 8 to 12 mg/kg/d for two consecutive days every two weeks for 6 to 8 doses through i.v.
15881730|NCT03791827|Drug|Mycophenolate Mofetil|The recommended dose of mycophenolate mofetil is 20 to 30mg/kg/d
15881731|NCT03791827|Drug|Azathioprine|The recommended dose of azathioprine is 1.5 to 2mg/kg/d
15881732|NCT03791827|Drug|Tacrolimus|The recommended dose of tacrolimus is 0.05 to 0.15mg/kg/d, Q12h
15881733|NCT03791827|Drug|Cyclosporine A|The recommended initial dose of cyclosporine A is 4 to 6mg/kg/d, Q12h
15881734|NCT03791827|Drug|Rituximab|The recommended dose of rituximab is 375mg/m2 once a week for 2 to 4 doses
15881735|NCT03791814|Drug|Zepatier|Patients screened as HCV positive will receive Zepatier for 12 weeks.
15881736|NCT03791801|Drug|Sugammadex|the reversal of neuromuscular blockade with sugammadex compared to neostigmine.
15881737|NCT03791801|Drug|Neostigmine|the reversal of neuromuscular blockade with sugammadex compared to neostigmine.
15881738|NCT03791801|Drug|Rocuronium|Both groups will receive rocuronium for paralysis during intubation
15881739|NCT03791801|Drug|Glycopyrrolate|The reversal of neuromuscular blockade with sugammadex compared to neostigmine/glycopyrrolate
15881740|NCT03791788|Diagnostic Test|QFR assessment|QFR measurement in order to evaluate functional significance of epicardial stenosis and to compare the response of QFR for worsening stenosis severity, FFR value as reference standard
15881741|NCT03791775|Drug|Polidocanol foam (Atossisclerol® 3%)|The procedure will be performed in the Sims position or lithotomy position. A modified Blonde-Blanchard technique will be adopted, with the tangential injection of polidocanol foam into the submucosa of the apex of each hemorrhoidal pile, without exceeding three piles, and using a self-lighting open-ended anoscope and a 20-G needle in order to reduce bleeding
15881742|NCT03791762|Procedure|WaveOne Gold|"WaveOne Gold was operated by an endomotor (VDW Gold, Munich, Germany) at WaveOne ALL setting."
15881743|NCT03791762|Procedure|Reciproc Blue|"Reciproc Blue was operated by an endomotor (VDW Gold, Munich, Germany) at Reciproc ALL setting."
15881744|NCT03791762|Procedure|ProTaper Next|ProTaper Next was operated by an endomotor (VDW Gold, Munich, Germany) with 16:1 contra angle at the settings suggested by the manufacturer (350 rpm, 3 Ncm).
15881745|NCT03791749|Other|Breastfeeding Support|12-minute simple technique
15881746|NCT03791736|Procedure|Injection of sandostatine|Intramuscular injection of sandostatin 30 mg 3 days before surgery
15881747|NCT03791723|Drug|Sacubitril-Valsartan|After catheter ablation,during a single blind, run-in period, participants received placebo. Then started with 50 mg LCZ696 for 2-4 weeks, then uptitrated to 100 mg bid for 2-4 weeks, and thereafter, uptitrated to 200 mg bid or tolerable maximum dose ≥6 months.
15881748|NCT03791723|Drug|Valsartan|After catheter ablation,during a single blind, run-in period, participants received placebo. Then started with 40 mg Valsartan daily (qd) for 2-4 weeks, then were uptitrated to 80mg qd or tolerable maximum dose ≥6 months.
15881749|NCT03791710|Procedure|autologous fat grafting|regular liposuction procedure at which sufficient amount of fat is extracted from the patient and then the fat is processed then grafted underneath the burn wound
15881750|NCT03791710|Drug|Topical Cream|serial dressing with topical agents e.g Silver Sulphadiazine
15881751|NCT03791710|Procedure|split thickness skin grafting|depridment and split thickness skin grafting
15881752|NCT03791697|Other|Telehealth 2 week postoperative visit|"The patient randomized into the telephone follow up group, will be contacted, at the pre-scheduled date and time, by the urogynecology clinic nurse. The nurse will utilize a scripted series of postoperative questions, which are consistent with questions asked during our standard postoperative clinic visits.
~Vital signs and physical examination will be deferred for the patients in the telephone follow up group.
~Any patient responses that are not consistent with a usual postoperative course will be escalated to an in person visit. However, these patients will remain in the group, to which they were originally randomized, for research analysis purposes. (Intent to treat)"
15881753|NCT03791684|Device|Cross linking|Cross linking strategy either standard or accelerated
15881754|NCT03791671|Other|individual balance training|One physiotherapist trains one Patient nearby a bar. The tasks changes in gage, visual feedback, vestibular feedback and underground. The Positions will be hodl for 10-30 seconds.
15881755|NCT03791671|Other|group balance training|Like the individual balance training
15881756|NCT03791658|Other|The 12-question TAI|The 12-question TAI (Test for the Adherence to Inhalers) yields a score indicating level of adherence (high, intermediate or poor). The TAI also provides some indication about the possible mechanisms of non-adherence (sporadic, deliberate or unconscious).
15881757|NCT03791658|Other|Information from patients file|Depending on which arm or group specific information will be gathered from the patients file after informed consent.
15881758|NCT03791658|Other|The Asthma Control Test (ACT)|An international validated questionnaire on the symptoms an asthmatic experiences and the disease control in the patient. Only for the Asthmatics arm of the study
15881759|NCT03791658|Other|The COPD Assessment Test (CAT)|An international validated questionnaire on the symptoms a COPD-patient experiences and the disease control in the patient. Only for the COPD arm of the study
15881760|NCT03791645|Behavioral|Sky Intervention|SKY meditation has three sequential components of breathing interspersed with normal breathing. These include a) sound breath: breathing against airway resistance with slight tightening of the laryngeal muscles, (2-3 cycles/min) followed by b) bellows breath: rapid, forced expiration(20-30 cycles/min) and c) regulated, rhythmical breathing rotating through medium to fast cycles. Each session is focused upon proper breathing techniques, social interaction, and discussion of practical wisdom for everyday life to manage the mind and emotions. SKY will be administered over a 5 day period (~3 hours/day), followed by 4 weekly follow-ups (~90 min session/week) at Signature Health clinic situated in Ashtabula, Ohio.
15881761|NCT03791632|Other|classical lecture style presentation|classical lecture style presentation
15881762|NCT03791632|Other|an intervention in the form of fun workshops|an intervention in the form of fun workshops on different themes by small groups of schoolchildren (8-10 children per workshop)
15881763|NCT03791632|Other|digital media intervention|digital media intervention
15881764|NCT03791619|Device|Higher Cylinder Toric IOL|Symfony Toric models ZXT300 and ZXT375 IOL
15881765|NCT03791619|Device|Lower Cylinder Toric IOL|Symfony Toric model ZXT150 IOL
15881766|NCT03791593|Drug|Evolocumab|Evolocumab is a human IgG2 monoclonal antibody, it will add to patient treatment during 12 months.
15881767|NCT03791580|Behavioral|Commitment nudge|"The commitment nudge will ask clinicians to commit to discussing high-risk polypharmacy at the next office visit with patients who have high-risk polypharmacy. Clinicians who commit will receive a reminder just before the next office visit begins. The patient will also receive notification of the commitment via EHR patient portal.
~This nudge will be operationalized via two sequential clinician-facing EHR best practice alerts (BPAs): the first at time of opening any encounter (including encounters other than a face-to-face office visit, e.g., medication refills), and the second (contingent on making a commitment to discuss high-risk polypharmacy) at time of opening the subsequent encounter for a face-to-face office visit. Each of these BPAs will describe the specific high-risk polypharmacy criterion (or criteria) the patient meets, the specific harms associated with the medication(s) triggering the criterion/criteria, and lower-risk alternative treatment strategies."
15881768|NCT03791580|Behavioral|Justification nudge|The justification nudge will ask clinicians who prescribe or renew a drug that meets high-risk polypharmacy criteria (in the context of the patient's other medications) to write a brief justification for prescribing this high-risk medication. This written justification will be recorded in the patient's medical record. The best practice alert requesting the justification will also describe the specific high-risk polypharmacy criterion (or criteria) the patient meets, the specific harms associated with the medication(s) triggering the criterion/criteria, and lower-risk alternative treatment strategies.
15881769|NCT03791567|Biological|Donislecel (allogeneic islets of Langerhans for transplant)|Intervention Description: The drug product consists of allogeneic human islets of Langerhans (islets) in serum-free transplant medium (indicator-free CMRL 1066 medium with HEPES, without sodium bicarbonate and supplemented with human albumin).
15881770|NCT03791554|Procedure|Group A (Lateral closed tunnel subepithelial CT graft)|Subepithelial connective tissue graft (autogenous graft) will be harvested from the palate by Single incision technique to be used with the adjacent teeth to treating gingival recession with edges of the recession sutured together after placing connective tissue graft
15881771|NCT03791554|Procedure|Group B (Tunnel procedure with subepithelial CT graft)|Subepithelial connective tissue graft (autogenous graft) will be harvested from the palate by Single incision technique to be used with the prepared tunnel to treating gingival recession
15881772|NCT03791541|Behavioral|Pharmacist services|Additional pharmacist/pharmacy student follow-ups, counseling, and other services
15881773|NCT03791528|Other|Kinesio-taping treatment group|In treatment group; Kinesio-taping 3 times at 5-day intervals, one of the fan-shaped cut bands, 2-3 inches above the SIJ, and the other below 2-3 inches below the SIJ, and crossed each other by 90 degrees. evaluated at baseline, the twentieth minute after application and on the 15th day by physical examination of the sacroiliac joint, visual analog scale, Modified Oswestry Low Back Pain Disability Questionnaire.
15881774|NCT03791515|Drug|Calcitonin Gene-Related Peptide|"A randomized clinical trial with a double-blinded, randomized, placebo-controlled crossover design. 30 PPTH patients will be included. All participants will receive continuous intravenous infusion of 1.5 µg/min CGRP over 20 min.
~The following variables will be recorded before, during and after infusion (every 10 min over 60 min): headache intensity on a verbal rating scale from 0 to 10 and headache characteristics. At 90 min, participants will be discharged and instructed to fill out a headache diary for 24 hours from start of infusion."
15881775|NCT03791515|Drug|Placebo|"A randomized clinical trial with a double-blinded, randomized, placebo-controlled crossover design. 30 PPTH patients will be included. All participants will receive continuous intravenous infusion of 40 mL placebo (isotonic saline) over 20 min.
~The following variables will be recorded before, during and after infusion (every 10 min over 60 min): headache intensity on a verbal rating scale from 0 to 10 and headache characteristics. At 90 min, participants will be discharged and instructed to fill out a headache diary for 24 hours from start of infusion."
15881776|NCT03791502|Other|Pilates Method Exercises|Pilates Method exercises performed on the apparatus, on the ground and with accessories. They will always be performed by a physiotherapist with teaching certification in the Pilates methodology and will be supervised by two properly trained physiotherapy trainees. Participants will start the exercise program in small groups of up to 8 people, twice a week for 60 minutes, for 12 weeks, totaling 24 sessions. The first day of intervention for both groups will be devoted to explaining the six principles described by Joseph Pilates: centralization, concentration, control, precision, fluidity and breathing, and some fundamentals such as the neutral position of the spine. And in all sessions, these principles will be remembered by the physiotherapist.
15881777|NCT03791489|Device|ClariFix|The ClariFix™ device (K162608) is an FDA 510(k) cleared Class II cryosurgical tool indicated for the destruction of unwanted tissue during surgical procedures, including in adults with chronic rhinitis.
15881778|NCT03791476|Drug|rhC1INH|C1 esterase inhibitor
15881779|NCT03791476|Other|Saline Solution|saline solution
15881780|NCT03791463|Drug|salvianolic acid A|Following an overnight fast of at least 10 hours, a single dose of 90 mg salvianolic acid A will be administered on 2 separate occasions (fasting and after meal) in a randomized crossover fashion with different food restrictions.
15881781|NCT03791437|Device|Digital chest drainage system|patients who received Digital chest drainage system
15881782|NCT03791437|Device|Not use Digital chest drainage system|patients who not received Digital chest drainage system( traditional drainage system)
15881783|NCT03791424|Drug|Midazolam|Administering premedication with sedative drug to relieve anxiety
15881784|NCT03791398|Drug|Dose level 1 ONC201 625mg|ONC201 625mg + Nivolumab 240mg IV flat dose
15881785|NCT03791398|Drug|Dose level 2 ONC201 500mg|ONC201 500mg + Nivolumab 240mg IV flat dose
15881786|NCT03791398|Drug|Dose level 3 ONC201 375mg|ONC201 375mg + Nivolumab 240mg IV flat dose
15881787|NCT03791385|Behavioral|Picture Exchange Communication System (PECS)|A communication system frequently used with non-verbal children with autism spectrum disorders (ASD) that uses a series of pictures that describe how a certain activity is done, in our case showing a structured method and technique for teeth brushing.
15881788|NCT03791372|Drug|0.9% Sodium Chloride|0.9% Sodium Chloride in control group
15881789|NCT03791372|Biological|Autologous Umbilical Cord Blood|Autologous Umbilical Cord Blood Mononuclear Cells Therapy in Cerebral Palsy for safety and effect evaluation.
15881790|NCT03791359|Other|CardioPulmonary Resuscitation|Whether the victim received CPR as per standard protocol.
15881791|NCT03791333|Other|injury severity score|injury severity score of multi trauma patients
15881792|NCT03791320|Diagnostic Test|Vessel Fractional Flow Reserve|FFR measurement based on coronary angiography
15881793|NCT03791307|Other|Traditional Pilates group|The participants will perform only exercises based on the traditional Pilates method, 2 times a week, for 50 minutes, for 16 weeks.
15881794|NCT03791307|Other|Modified Pilates group|The participants will perform exercises based on the Pilates method alternated with active rest periods on treadmill ergometer, 2 times a week, for 50 minutes, for 16 weeks.
15881795|NCT03791294|Drug|TIAB: microcrystalline titanium dioxide with covalently linked monovalent silver ions|TIAGIN vaginal capsule, composition: TIAB (microcrystalline titanium dioxide with covalently linked monovalent silver ions), Sodium Hyaluronate, Aloe Barbadensis Extract
15881796|NCT03791281|Behavioral|BASIS|
15881797|NCT03791281|Behavioral|Attention Control|
15881798|NCT03791268|Procedure|Gastric cancer surgery|Gastric cancer surgery is performed according to the Japanese Guidelines. Patients will intraoperative evaluate the edema, fibrosis and exudation.
15881799|NCT03791255|Drug|Calcium silicate liner|new light-cured resin-modified calcium silicate-filled base/ liner material designed for direct and indirect pulp capping
15881800|NCT03791255|Drug|Calcium hydroxide liner|Calcium hydroxide is the gold standard for pulp capping, allows for the formation of a reparative dentin bridge
15881801|NCT03791242|Device|Cpap and ketogenic diet|Patients with severe OSAS who are BS candidates will be treated with CPAP only at night (Group 1), or CPAP at night + KMED daily (Group 2), for 4 weeks
15881802|NCT03791216|Other|Fasting blood draw for lipid assessments|Fasting blood draw for lipid assessments
15881803|NCT03791203|Behavioral|Calorie restriction (MACR)|This was a randomized, single-blind controlled trial with modified alternate-day calorie restriction (MACR) as the active intervention and normal habitual diet as control at Hospital University of Sains Malaysia.
15881804|NCT03791190|Other|Regional citrate anticoagulation|Sodium citrate (4%) infusion before the filter in order to maintain post-filter ionCa2+ level between 0.25 to 0.35 mmol/L. Calcium gluconate supplementary after the filter to maintain serum ionCa2+ level between 1.0 to 1.2 mmol/L.
15881805|NCT03791190|Other|No-anticoagulation|Patients accepted CRRT without anticoagulant.
15881806|NCT03791177|Other|Music Therapy|"Patients in the study group were exposed to flute music therapy (Sufi musical recital - Huseyni mode) at low tempo (60-80 rhythm / min) with weak beats and calm rhythms during the UDS.
~This audition involves both vocal and instrumental music performed by a reed flute called 'Ney'. A competent lecturer who was specialized in music suggested all the musical compositions during the therapy"
15881807|NCT03791164|Behavioral|The Pain Toolkit|the Pain Toolkit is a leaflet that encourages self management techniques for patients with chronic pain
15881808|NCT03791164|Behavioral|the Back Book|The Back Book is a patient information leaflet that offers information and advice about back pain
15881809|NCT03791138|Other|online patient decision aid|An online, interactive tool that can be used to prepare for consultation with a plastic surgeon which contains evidence-based information about breast reconstruction options, the pros and cons of the options, value clarification exercises and patient narratives. It results in a summary sheet with patients' personal values and questions that can be discussed during consultation with a plastic surgeon.
15881810|NCT03791125|Drug|Salvianolic Acid A|4 anticipated doses are 30 mg, 90 mg, 180 mg and 270 mg, respectively. All of these are single-dose study.
15881811|NCT03791125|Drug|Placebo Oral Tablet|Placebo tablets containing no salvianolic acid A will be given to healthy subjects.
15881812|NCT03791112|Drug|BPI-16350|BPI-16350 capsules administered orally
15881813|NCT03791099|Drug|Metronidazole|After subgingival ultrasonic scaling is performed, metronidazole in polymer matrix is applied to the selected periodontal pockets.
15881814|NCT03791060|Drug|Secukinumab|Secukinumab is selective for human IL-17A and potently neutralizes the bioactivity of this cytokine. IL-17A is the central cytokine in multiple autoimmune and inflammatory processes. It is being recognized as one of the principal pro-inflammatory cytokines in autoimmune diseases such as psoriasis, PsA and AS, uveitis and is thought to play a role in other inflammatory conditions.
15881815|NCT03791047|Other|Balance Analysis|Balance analysis is assessment method to estimate fall of risk and deterioration of postural control.
15881816|NCT03791021|Diagnostic Test|draw a person (DAP)|the subjects will be given a blank sheet of white paper and a pencil, and will be asked to draw themselves with no other additional instructions.
15881817|NCT03791021|Diagnostic Test|Edinburgh Postnatal Depression Scale (EPDS)|measure of postpartum depression symptoms.
15881818|NCT03791021|Diagnostic Test|Beck Depression Inventory- II (BDI-II)|BDI-II is based on clinical observations of behaviors associated with depression, and it retains the somatic items in accordance with the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria related to loss of energy. ansd sleep disturbances.
15881819|NCT03791021|Diagnostic Test|Traumatic Events Questionnaire (TEQ)|The TEQ assesses experiences with nine specific types of traumatic events (e.g., accidents, crime, adult abusive experiences) reported in the empirical literature as having the potential to elicit PTSD symptoms.
15881820|NCT03791008|Other|Risk based screening|Breast cancer risk measurement, screening recommendations and shared decision making
15881821|NCT03790995|Procedure|Robot assisted laparoscopic prostatectomy|
15881822|NCT03790982|Drug|Placebo of AD-35 60mg /AD-35 30mg|Placebo 60mg, oral, 1st 26 weeks; AD-35 30mg +Placebo of AD-35 30mg oral 2nd 26 weeks.
15881823|NCT03790982|Drug|Placebo of AD-35 60mg /AD-35 60mg|Placebo 60mg, oral, 1st 26 weeks; AD-35 60mg oral, 2nd 26 weeks.
15881824|NCT03790982|Drug|AD-35 30 mg + Placebo of AD-35 30 mg|AD-35 30 mg + Placebo of AD-35 30 mg AD-35 30 mg + Placebo of AD-35 30 mg, Oral, 52 weeks.
15881825|NCT03790982|Drug|AD-35 60 mg|AD-35 60 mg AD-35 30 mg x two tablets, oral, 52 weeks.
15881826|NCT03790969|Device|26 gauge needle|smaller gauge needle
15881827|NCT03790969|Device|23 gauge needle|control group
15881828|NCT03790956|Procedure|Silk Microparticle Filler Injection|A silk protein microparticle-based filler will be injected deep to the thyroarytenoid muscle of the paralyzed vocal fold to augment/medialize its position.
15881829|NCT03790943|Diagnostic Test|cardiac assessment|Personal history, physical examination including anthropometry with hip/waist-ratio, electrocardiogram, echocardiography, 1-minute-sit-to-stand test, questionnaires on health-related quality of life (SF-36), diet, physical activity, and fatigue
15881830|NCT03790930|Diagnostic Test|deep learning|manually labeled samples will be used to train, validate and test deep learning algorithm, and then realize automatic classification.
15881831|NCT03790904|Other|Co.|15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min
15881832|NCT03790904|Other|Kin|15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min
15881833|NCT03790904|Other|Distilled water|15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min
15881834|NCT03790891|Biological|CD19-TriCAR-T/SILK|A conditioning chemotherapy regimen of fludarabine and cyclophosphamide may be administered, followed by a single infusion of CD19-TriCAR-T cells or 4 repeat infusions of CD19-TriCAR-SILK cells.
15881835|NCT03790878|Behavioral|Mindful Breathing|Training in a mindful breathing skill that reduces emotional distress
15881836|NCT03790878|Behavioral|Habituation|An exposure procedure that reduces emotional distress through habituation
15881837|NCT03790878|Behavioral|Control|No emotion regulation intervention, placebo
15881838|NCT03790865|Drug|Livoletide|Daily subcutaneous injection
15881839|NCT03790865|Drug|Placebo|Daily subcutaneous injection
15881840|NCT03790852|Drug|KSI-301|Intravitreal injection
15881841|NCT03790839|Drug|Sitagliptin|Sitagliptin (Januvia® 100 mg tablets for oral administration)
15881842|NCT03790839|Drug|Dorzagliatin|Glucokinase activator currently under development
15881843|NCT03790826|Device|cystoscopy|Comparison of bladder mucosa via cystoscopy.
15881844|NCT03790813|Diagnostic Test|Intervention 1|Ki-67 and Oncotype DX® will be performed on the baseline core biopsy specimen prior to initiation of neoadjuvant systemic therapy.
15881845|NCT03790813|Diagnostic Test|Intervention 2|MRI will be performed prior to initiation of neoadjuvant systemic therapy and at the end of treatment.
15881846|NCT03790800|Drug|urapidil|A standard treatment regime based on intravenous (IV) bolus of 25mg urapidil administered over 1 minute. For those patients initial systolic blood pressure 180, another 25mg urapidil bolus will be given if the systolic blood pressure level persists >150 after 5 minutes.
15881847|NCT03790787|Drug|Empagliflozin|Empagliflozin as Jardiance® 25 mg film-coated tablets for oral administration
15881849|NCT03790774|Behavioral|Neurofeedback|Participants receive intermittent visual and auditory cues to adjust their attentional engagement with a letter identification task.
15881850|NCT03790761|Behavioral|PREP 8.0 Curriculum|The PREP 8.0 curriculum is an experiential curriculum designed to be implemented in a workshop or educational setting. Using techniques of cognitive-behavioral marital therapy and communication-oriented marital enhancement, PREP aims to help couples achieve high levels of relationship functioning and prevent marital problems. The PREP approach is based on research in the field of relational and marital health and success conducted at the University of Denver.
15881851|NCT03790748|Procedure|Standard Lumbar Epidural Technique|Standard Lumbar Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.
15881852|NCT03790748|Procedure|25G Dural Puncture Epidural Technique|25G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.
15881853|NCT03790748|Procedure|27G Dural Puncture Epidural Technique|27G Dural Puncture Epidural Technique at L4-5 inter-space using 0.5%Bupivacaine and Fentanyl.
15881854|NCT03790735|Diagnostic Test|FISH|Targeted chromosomal aberrations detection
15881855|NCT03790722|Other|Ergometry H|"After a pre-rest period of 12 minutes, the subjects are physically strained on the ergometer for 48 minutes (6 minutes loading phase followed by a 2-minute rest phase; 30 watts increase every 8 minutes up to a maximum load of 180 watts), followed by a 12-minute rest periodmaximum load of 180 watts), followed by a 15-minute post-rest period.
~Mobil-O-Graph PWA blood pressure cuff is applied to the upper arm with the previously determined higher systolic blood pressure (reference parameter).
~SOMNOtouchTM RESP and GeTeMed Vitaguard 3100 are accordingly applied to the arm with the previously determined lower systolic blood pressure."
15881856|NCT03790722|Other|Ergometry L|"After a pre-rest period of 12 minutes, the subjects are physically strained on the ergometer for 48 minutes (6 minutes loading phase followed by a 2-minute rest phase; 30 watts increase every 8 minutes up to a maximum load of 180 watts), followed by a 12-minute rest periodmaximum load of 180 watts), followed by a 15-minute post-rest period.
~Mobil-O-Graph PWA blood pressure cuff is applied to the upper arm with the previously determined lower systolic blood pressure (reference parameter).
~SOMNOtouchTM RESP and GeTeMed Vitaguard 3100 are accordingly applied to the arm with the previously determined higher systolic blood pressure."
15881857|NCT03790709|Drug|High dose ANAVEX2-73|Oral capsule
15881858|NCT03790709|Drug|Mid dose ANAVEX2-73|Oral capsule
15881859|NCT03790709|Drug|Placebo oral capsule|Oral capsule
15881860|NCT03790696|Device|Cognitive Training Program|"The cognitive training program has been designed by Dr. Sylvester. It is a simple computer game looking at some shapes and faces on a computer screen and pressing a button when a target shape appears.
~This is the first study to use this exact computer training regimen for testing in its ability to reduce symptoms of anxiety in children with anxiety disorders. Each session of the computer game takes approximately 45-60 minutes and subjects complete 8 total sessions over one month. The computer game involves paying attention to parts of the screen while distracting square boxes appear at other locations. A target X appears at the location that participants are paying attention to and the subjects press a button when it appears."
15881861|NCT03790683|Device|EnsoETM|Patients having major surgery will have the EnsoETM device placed after induction of general anesthesia in addition to standard of care surface warming.
15881862|NCT03790683|Device|Surface Warming|Forced air warming device will be placed on the patient according to standard practice.
15881863|NCT03790670|Drug|sargramostim|Recombinant human GM-CSF produced by recombinant DNA technology using a yeast (S. cerevisiae) expression system
15881864|NCT03790657|Behavioral|practice of a complex walking task|walking over obstacles
15881865|NCT03790657|Device|Dosage A: transcranial direct current stimulation (tDCS)|mild electrical stimulation delivered to the frontal region of the brain
15881866|NCT03790657|Device|Dosage B: transcranial direct current stimulation (tDCS)|mild electrical stimulation delivered to the frontal region of the brain
15881867|NCT03790644|Device|exoskeleton assist|"A powered exoskeleton describes a wearable robot designed around the shape and function of the human body with segments and joints externally coupled to those of the user. The exoskeleton includes a rigid outer frame, sensors that detect a user's desired movements, a computerized controller, motors and actuators, and lightweight batteries.
~The exoskeleton is designed to be worn in the community."
15881868|NCT03790631|Other|The study is observational.|The study is observational.
15881869|NCT03790618|Drug|3,4-Methylenedioxymethamphetamine|Participants will be given 0.75mg/kg of 1.5mg/kg MDMA
15881870|NCT03790618|Drug|methamphetamine|Please see above.
15881871|NCT03790605|Drug|1 % curcumin chip|CURCUMIN CHIP: 4x5x0.5mm chip of 1% curcumin in biodegradable hydroxy propyl methyl cellulose vehicle
15881872|NCT03790605|Other|Placebo chip|PLACEBO CHIP: 4x5x0.5mm chip (identical to test chip except for the active therapeutic ingredient) in biodegradable hydroxy propyl methyl cellulose vehicle
15881873|NCT03790605|Procedure|Scaling and root planing|Routine full mouth scaling and root planing within 48 hours will be performed at baseline prior to local placement of the chips
15881874|NCT03790592|Device|trifocal IOL|intraocular lens
15881875|NCT03790566|Drug|Bupivacaine|0.5 ml/kg 0.25% bupivacaine
15881876|NCT03790553|Radiation|Radiotherapy|Different total radiotherapy dose between two arms.
15881877|NCT03790540|Device|DentalVibe|It is a vibrotactile device that aids in reducing pain during local anesthesia injection in pediatric patients
15881878|NCT03790540|Drug|Topical Benzocaine 20%|Topical benzocaine 20% gel on the mucosal injection site prior to injection
15881879|NCT03790527|Procedure|CBM training|participants will be random-assigned into one of training groups. Participants in the modification group will receive modified training of 400 trials for six sessions during six days, the same as the sham group.The difference between these two groups is the proportion of push/pull trials. The sequence of the interventions will be counterbalanced across participants, and the callback will be conduct after one week.
15881880|NCT03790527|Procedure|Sham training|participants will be random-assigned into one of training groups. Participants in the modification group will receive modified training of 400 trials for six sessions during six days, the same as the sham group.The difference between these two groups is the proportion of push/pull trials. The sequence of the interventions will be counterbalanced across participants, and the callback will be conduct after one week.
15881881|NCT03790514|Other|Heat Wrap|Commercially heat tapes ( without drugs) will be applied to patients.
15881882|NCT03790501|Other|No intervention|As an observational study, no intervention will be associated with the study group.
15881883|NCT03790488|Drug|JTX-4014|Specified dose on specified days
15881884|NCT03790475|Other|Offering a choice for colorectal cancer screening|Persons randomized to the multiple options screening strategy group will receive a postal invitation offering a choice between FIT and colonoscopy.
15881885|NCT03790475|Other|Offering an alternative colorectal cancer screening method|Persons randomized to the sequential screening strategy group will receive a postal invitation to the colonoscopy followed by a postal invitation for screening using FIT for non-responders and subjects refusing colonoscopy.
15881886|NCT03790462|Other|Music intervention|"A raga out of 3 select Indian classical ragas Puriya/Hindol/Todi will be played for 10 minutes & data collected."
15881887|NCT03790449|Behavioral|PreLiFe-programme|The intervention group will receive a mobile preconception lifestyle programme (the PreLiFe-programme) in addition to standard care for 12 months or until an ongoing pregnancy is confirmed by ultrasound. The PreLiFe-programme includes a mobile application (PreLiFe-app) with the same treatment information as the attention control group in combination with a lifestyle programme. This new lifestyle programme includes tailored advice and skills training on diet and physical activity and mindfulness exercises. Additionally couples will be offered interaction with a health care provider through text messages and telephone interaction following the concept of blended care.
15881888|NCT03790449|Behavioral|Attention Control Programme|The standard care serving as control for this intervention is fertility treatment i.e. IVF with or without ICSI according to local protocols for infertility patients. This implies no guidance on lifestyle. However, to have attention control the control group will receive an attention control programme. The attention control programme includes a mobile application (app) with treatment information including medication instructions, reminders of injection of human Chorionic Gonadotropin (hCG) and time of fertility treatment appointments for 12 months or until an ongoing pregnancy is confirmed by ultrasound.
15881889|NCT03790436|Dietary Supplement|Betaquik|"Study dietitian will advise each participant on target volume of Betaquik (45g MCT, 225mL Betaquik). Consuming too much MCT too quickly may cause gastrointestinal discomfort such as abdominal pain or diarrhea, this is related to its assimilation to the body. Any symptoms that do occur normally resolve in the majority of patients, and with time and persistence, GI tolerance is usually established.
~Therefore the study dietitian will advise on a gradual systematic introduction to minimize any adverse effects. The daily-tolerated amount will be divided into 3-4 equal portions, taken regularly throughout the day. subjects will be advised to always take Betaquik with food, as part of meals and snacks, to help promote gastrointestinal tolerance. The goal is within the first 4 weeks participants will have reached their tolerated target volume of Betaquik."
15881890|NCT03790423|Drug|Injection of 18F-ASIS|Each patient will receive one injection of 18F-ASIS (approximately 200 Mbq)
15881891|NCT03790423|Other|PET/CT scan|Following one injection of 18F-ASIS the patients will be PET/CT scanned at 1 hour, 2 hours and 4 hours post-injection
15881892|NCT03790410|Other|Complex pulmonary rehabilitation|Complex pulmonary rehabilitation program containing breathing exercises, bicycle ergometer conditionings, relaxations, strength and endurance trainings.
15881893|NCT03790410|Other|Inspiratory muscle training|The training program contains strengthening exercises on the diaphragm muscle.
15881894|NCT03790397|Drug|Osimertinib|Patients treated with Osimertinib within the Special Use medication Program (SUMP).
15881895|NCT03790384|Drug|Mitomycin|Patients receive BCG induction treatment according to the standard protocol (an instillation once a week for six weeks) with ImmuCyst (81 mg Connaught strain BCG) with a 40 mg mitomycin instillation the day before .
15881896|NCT03790371|Drug|Misoprostol|vaginal misoprostol prior IUD insertion
15881897|NCT03790371|Drug|Placebos|vaginal placebo tablet prior IUD insertion
15881898|NCT03790358|Drug|Lysergic Acid Diethylamide|Drug will be administered in solution form.
15881899|NCT03790345|Drug|Pyridoxine|Adjuvant daily treatment with 200mg of pyridoxine
15881900|NCT03790345|Drug|Cobalamin|Adjuvant daily treatment with 2mg of cobalamin
15881901|NCT03790345|Drug|Placebo Oral Tablet|Adjuvant daily treatment with placebo
15881902|NCT03790332|Drug|Ibrutinib|Ibrutinib capsule, tablet, or suspension administered orally once daily
15881903|NCT03790319|Behavioral|The Power of Feelings|"Three workshops of three days each teach about the five basic feelings rage, sadness, fear, shame and joy and talk about the powerful and destructive qualities they can have. In addition to that they are about how to deal with emotions, which are defined as unfelt feelings of the past.
~Smaller lectures give the participants an overview about the themes. Through exercises the participants can make experiences p.e. about each of the feelings. Another element is the sharing in dyads or small groups about actual feelings to practice emotional disclosure and to build a culture of openness and compassion."
15881904|NCT03790319|Behavioral|The Emotional Backpack|"One workshop of three days teach about how to deal with emotions, which are defined as unfelt feelings of the past. They show a way to work in couples with a form of emotional disclosure that helps process emotions that have been overwhelming in the past.
~Smaller lectures give the participants an overview about the themes. Through exercises the participants can make experiences p.e. about each of the feelings. Another element is the sharing in dyads or small groups about actual feelings to practice emotional disclosure and to build a culture of openness and compassion."
15881905|NCT03790293|Drug|Rituximab|Patient was enrolled into the RITUXIMAB 3 study in the arm Rituximab in association with low corticosteroids'therapy
15881906|NCT03790293|Drug|corticosteroids'therapy|Patient was enrolled into the RITUXIMAB 3 study in the arm Patient was enrolled into the RITUXIMAB 3 study in the arm standard corticosteroid
15881907|NCT03790280|Diagnostic Test|HFO analysis|We hypothesize that the strategy of incorporating HFO data to a standard ECoG-guided resection in pediatric epilepsy surgery will result in improved postoperative seizure outcome than the traditional approach.
15881942|NCT03789890|Drug|BAY1902607|BAY1902607 is administered once orally as tablets on Day 2 of study period 1 and on Day 4 of study period 2.
15881943|NCT03789890|Drug|Itraconazole|Itraconazole is administered at a dose of 200 mg once a day (oral solution of 10 mg mL-1) on Day 1 to Day 14 of study period 2.
15881908|NCT03790267|Other|Questionnaire administration|One questionnaire (Euro Quality 5 Dimensions, EQ-5D) for the general assessment of patient's health status will be administered to all the patients in the study. One joint-specific questionnaires will be administered to patients depending on the surgery procedure they will be undergoing. Hip disability and Osteoarthritis Outcome Score - Short Form (HOOS-PS) for patients undergoing hip replacement (6); Knee injury and Osteoarthritis Outcome Score - Short Form (KOOS-PS) for patients undergoing knee replacement (7); the American Shoulder and Elbow Surgeons Standardized Shoulder Assessment Form (ASES), for patients undergoing shoulder implants.
15881909|NCT03790254|Other|systematic review|
15881910|NCT03790241|Procedure|insertion of a catheter|Analysis the palpation and perforation motion performed by the practitioner during the insertion of a catheter while measuring the loads applied on the skin and the veins
15881911|NCT03790228|Drug|Anlotinib Combined With Pemetrexed And Carboplatin|Anlotinib(12mg, QD, PO, d1-14, 21 days per cycle) plus Pemetrexed (500mg/m2, IV, d15-21,21 days per cycle) and Carboplatin(AUC5,IV, d15-21,21 days per cycle,using 4 cycles)
15881912|NCT03790215|Drug|Dydrogesterone|The investigators give participants oral dydrogesterone(as described in arm description).After 3 cycles of treatment, the investigators evaluate the treatment effects.
15881913|NCT03790202|Device|VistaCare®|Controlled atmosphere wound healing device
15881914|NCT03790189|Biological|Subchondral and intra-articular injection of BMC|Bone Marrow concentrate will be injected intra-articularly and at the bone-cartilage interface both in the tibia and femur of patients affected by unicompartmental knee osteoarthritis
15881915|NCT03790176|Drug|Intravenous Infusion|see arm/group description. NO INTERVENTION IN STUDY GROUP B! PATIENTS OF GROUP B WILL RECEIVE CAZ/AVI INDEPENDENTLY FROM STUDY PARTICIPATION BASED ON DECISION OF THEIR TREATING PHYSICIAN
15881916|NCT03790163|Drug|Levobupivacaine|Drug: levobupivacaine at room temperature ( 23˚C) and second group levobupivacaine warmed to the (30˚C) while the third group levobupivacaine warmed to the body temperature (37˚C)
15881917|NCT03790150|Other|Evidence-based practices|Implementation of evidence-based practices
15881918|NCT03790137|Drug|Fenfluramine Hydrochloride|Fenfluramine Hydrochloride will be supplied to the treatment group as an oral solution in a concentration of 2.5 mg/mL. Subjects will receive their daily dose of Fenfluramine Hydrochloride in two doses (one in the morning and one in the evening). After a four week baseline, subjects that meet enrollment criteria will enter a titration period. The starting dose will be 0.2 mg/kg/day for the first 14 days. The dose will be increased every 2 weeks as tolerated by 0.2 mg/kg/day, to a maximum dose of 0.8 mg/kg/day, or a total maximum dose of 30 mg/day. The subject will remain on a dose of 0.8 mg/kg/day, 30 mg/day, or maximum tolerated daily dose for a 6 week maintenance period.
15881919|NCT03790111|Drug|telotristat ethyl|XERMELO (telotristat ethyl) tablets administered as 250 mg (1 x 250-mg tablet) tid plus 1L therapy for 7 days, then XERMELO (telotristat ethyl) tablets administered as 500 mg (2 x 250-mg tablets) tid plus 1L therapy for the duration of the study
15881920|NCT03790098|Behavioral|Restorative-Flow Yoga|Restorative yoga consists of a series of gentle poses, supported by props, with an emphasis on breathing and relaxing; as opposed to stretching or contracting muscles, it is designed to support muscles. Flow yoga consists of a series of linked poses synchronized with the breath.
15881921|NCT03790085|Drug|Risperidone|Risperidone tablet
15881922|NCT03790085|Drug|Olanzapine|Olanzapine tablet
15881923|NCT03790085|Drug|Aripiprazole|Aripiprazole tablet
15881924|NCT03790072|Biological|OmnImmune®|infusion of OmnImmune® (expanded gamma delta T lymphocytes)
15881925|NCT03790059|Drug|H101|Intraoperative injection of H101 can improve the efficacy of RFA in hepatocellular carcinoma.
15881926|NCT03790059|Procedure|RFA|Treat the samll HCC with the RFA.
15881927|NCT03790033|Drug|Ucha-Shinki-Hwan|"Product name : Bosinji Granule Manufacturer : Tsumura & Co. Ingredient : Bosinji granule 2.5g (Bosinji extract 1.523g)
~Bosinji extract is composed of following proportion of ingredient
~Rehmannia Root 1.7g Achyranthes Root 1.0g Cornus Fruit 1.0g Dioscorea Rhizome 1.0g Psyllium Husk 1.0g Alisma Rhizome 1.0g Hoelen 1.0g Moutan Root Bark 1.0g Cinnamon Bark 0.3g Pulvis Aconiti Tuberis Purificatum 0.3g"
15881928|NCT03790033|Drug|Placebo|placebo granule
15881929|NCT03790020|Drug|Bupivacaine|In our study this local anesthetic agent will be applied for postoperative pain relief
15881930|NCT03790007|Drug|Bupivacaine|In our study this local anesthetic agent will be applied for postoperative pain relief
15881931|NCT03789994|Behavioral|Affective touch|The affective touch comprises of two elements, namely the signal of care, love and acceptance, and stimulation of CT afferent of the skin. Caregivers will be trained to perform light stroking on stroke survivor's forearm while reviewing happy events with the use of photos.
15881932|NCT03789994|Other|Fine motor exercise|Fine motor exercises that are commonly used for rehabilitation.
15881933|NCT03789981|Genetic|Immunogenic profile|RNA sequencing (RNAseq), Whole exome sequencing (WES), NeoAntigens (NeoAg), Immune checkpoints analysis, Gene expression profiling
15881934|NCT03789968|Drug|bictegravir/emtricitabine/tenofovir alafenamide|Treatment experienced patients with HIV infection that switched to a bictegravir/emtricitabine/tenofovir alafenamide-based ART regimen
15881935|NCT03789955|Procedure|Fluoroscopic-guided TEB|When performing a fluoroscopic-guided thoracic epidural block (TEB), an 18-gauge Tuohy needle will be used for interlaminar epidural access. If the epidural space was accessed under fluoroscopic guidance and using the loss of resistance technique with air. All procedures will be performed with a paramedian approach under the true AP and lateral view at first, If the interlaminar space is not visible, the CLO view will be used. If the needle is deemed to be in the epidural space when the loss occurred, six fluoroscopic views will be obtained: true AP, CLO at 40 degrees, 50 degrees, 60 degrees, CLO measured, and lateral. The CLO measured angle will be determined by measuring the angle between the superior lamina and spinous process on the midsagittal plane on thoracic MRI or CT.
15881936|NCT03789942|Procedure|Oral surgery|Oral surgery procedures
15881937|NCT03789929|Behavioral|The Emotional Backpack|In this 4 weeks course participants learn how to process difficult emotions that has been overwhelming in the past. They learn how they can use the support of other people and support other people in the processing emotions within a simple and easy to learn setting.
15881938|NCT03789929|Behavioral|Feelings as Powers|In this 3 months course participants learn about the empowering potential of their feelings as well as the difficult aspects of them. In addition to that they learn techniques how to deal with difficult emotions.
15881948|NCT03789864|Diagnostic Test|single-arm, non-randomized Biodynamic imaging (BDI)|Skin punch biopsy samples from cutaneous lesions will be profiled for sensitivity to gemcitabine using ex vivo Biodynamic imaging (BDI). The primary clinical outcome assessed will be objective response to chemotherapy after 2 cycles of treatment.
15881949|NCT03789851|Device|core needle biopsy|Because the ultrasound was unable to accurately position the marker clip, I125 coud be placed at the position of the marker clip under the guidance of preoperative mammography. The gamma detector was used to locate the tumor bed to guide the ultrasound-guided multi-point CNB. Ultrasound-guided multipoint CNB was used directly after breast conserving surgery or mastectomy. Centering on the marker clip, the range of 0.5 cm was the first area, and then the range of 0.5 cm was the second area, and so on, until the extent of the expansion reached the long diameter of the original tumor, and 4 pieces were uniformly taken in each area.
15881950|NCT03789838|Other|Sepsis rapid response team|Patients with suspected sepsis is managed by a sepsis rapid response team in a structured manner.
15881951|NCT03789812|Device|Manual toothbrush|Soft manual toothbrush (Oral B) will be used to brush occlusal, buccal and lingual teeth surfaces.
15881952|NCT03789812|Device|Electric Toothbrush|Electric toothbrush (Jetpik JP210) will be used to brush occlusal, buccal and lingual teeth surfaces.
15881953|NCT03789812|Device|Superfloss|Superfloss (Oral B) will be used to clean interproximal teeth surfaces.
15881954|NCT03789812|Device|Dental Water Jet|Dental water jet (Jetpik JP210) will be used to clean interproximal teeth surfaces.
15881955|NCT03789799|Other|TIAB: microcrystalline titanium dioxide with covalently linked monovalent silver ions|TIAGIN vaginal capsule, composition: TIAB (microcrystalline titanium dioxide with covalently linked monovalent silver ions), Sodium Hyaluronate, Aloe Barbadensis Extract
15881956|NCT03789799|Other|Placebo|Placebo vaginal capsule, composition: Sodium Hyaluronate, Aloe Barbadensis Extract
15881957|NCT03789786|Diagnostic Test|Gait and Motion Analysis|Gait and motion analysis is comprised of 3-dimensional kinematics and kinetics, electromyography, energy expenditure, and physical exam (range of motion, strength, spasticity, etc.)
15881958|NCT03789786|Diagnostic Test|Gross Motor Function Measure (GMFM)|Gross Motor Function Measure (GMFM) is an assessment used to evaluate gross motor function over time in individuals with cerebral palsy. The assessment is comprised of movement activities like standing, walking, running, and jumping
15881959|NCT03789786|Behavioral|Surveys|Six surveys are used to assess function, activity, participation, pain, quality of life, and treatment history
15881961|NCT03789760|Drug|SaiLuoTong capsule|500 subjects are randomly divided into two groups by 3:1. 375 subjects in the active group take two pills(120mg) of SaiLuoTong capsule each time, twice a day, 0.5 hours before breakfast and dinner, taking with lukewarm water.
15881962|NCT03789760|Drug|placebo|500 subjects are randomly divided into two groups by 3:1. 125 subjects in the control group take two pills(120mg) of placebo each time, twice a day, 0.5 hours before breakfast and dinner, taking with lukewarm water.
15881963|NCT03789747|Other|As a observational study, there is no intervention.|As a observational study, there is no intervention.
15881964|NCT03789734|Biological|BLS-M22|BLS-M22 250mg/capsule
15881965|NCT03789734|Other|Placebo|BLS-M22 placebo 250mg/capsule
15881966|NCT03789721|Other|Medical Record Abstraction|Collect clinical and epidemiological data through medical record abstraction and self-reported questionnaire survey semi-annually.
15881967|NCT03789721|Other|Biospecimen Sample Collection|Collect research samples, when feasible for those diagnosed with ALD.
15881968|NCT03789708|Dietary Supplement|Gum Arabic|Instantly soluble granules of Gum Arabic; 100% Acacia Senegal
15881969|NCT03789708|Other|Placebo|Maltodextrin powder, easily soluble
15881970|NCT03789695|Drug|Dabigatran Etexilate|Study drug dabigatran etexilate. There are two dosage regimens of dabigatran etexilate used in the study: 150 mg b.i.d. and 110 mg b.i.d. The dose of dabigatran etexilate will be chosen by the investigator in accordance with Russian PRADAXA SmPC
15881971|NCT03789682|Drug|Adjuvant chemotherapy|adjuvant chemotherapy using Gemcitabine plus Cisplatin
15881972|NCT03789669|Device|Cheetah femtosecond laser and Cheetah patient interface|Ophthalmic laser surgical system
15881973|NCT03789669|Device|IntraLase iFS iFS femtosecond laser and patient interface|Commercial ophthalmic laser surgical system
15881974|NCT03789669|Device|Cheetah femtosecond laser and cheetah patient interface|Ophthalmic laser surgical system
15881975|NCT03789656|Drug|Paltusotine|Paltusotine, capsules, once daily by mouth
15881976|NCT03789643|Drug|JTT-251|Active drug tablets containing JTT-251
15881977|NCT03789643|Drug|Placebo|Placebo tablets matching in appearance to the active drug tablets
15881978|NCT03789630|Device|Continuous physiology monitoring in ambulatory setting pre and post surgery|This study will recruit 151 patients aged 21 to 80 years who will be undergoing total knee replacement surgery. All study participants undergoing total knee replacement surgery will be monitored using the wearable biosensor to continuously monitor physiology biomarkers. Participants will be followed for an estimated total of 39 days, beginning four days before surgery, the entire period during in-patient recovery (four to five days), and 30-days post-discharge at-home.
15881979|NCT03789617|Biological|EBViNT Cell|"Dosage: 1 bag containing 1.4x10^9 cells/100mL
~Administration: Inject intravenously over 30 minutes
~Dosing schedule: Single dose"
15881982|NCT03789591|Drug|Hydroxyurea|The alternative arm will use PK data to choose a starting hydroxyurea dose to achieve an AUC of 115 mg*h/L to approximate maximum tolerated dose. On the standard arm, participants will start at the traditional, weight-based dose of 20 mg/kg/day. Following selection of the starting dose, all participants will follow the same dose escalation and laboratory monitoring procedures.
15882022|NCT03789201|Device|TMS EEG|attempt to use TMS EEG to measure connectivity between cortical areas
15881983|NCT03789578|Drug|NNC0148-0287sema|Study staff will inject NNC0148-0287sema, 175unit (U)/0.5 mg in the morning after fasting under the skin of participants' thigh using a needle and a pen.
15881984|NCT03789578|Drug|Semaglutide|Study staff will inject semaglutide, 0.5 mg alone in the morning after fasting under the skin of participants' thigh using a needle and a pen.
15881985|NCT03789578|Drug|NNC0148-0287|Study staff will inject insulin 287 (NNC0148-0287), 175U alone in the morning after fasting under the skin of participants' thigh using a needle and a pen.
15881986|NCT03789565|Other|Biomarker test|Diagnostic biomarker study
15881987|NCT03789552|Drug|T89 capsule|T89 capsules (75mg)
15881988|NCT03789552|Drug|Placebo capsule|Placebo capsules (0mg)
15881989|NCT03789539|Biological|LD Universal Influenza Vaccine Uniflu|low dose Universal Influenza Vaccine Uniflu
15881990|NCT03789539|Biological|HD Universal Influenza Vaccine Uniflu|High dose Universal Influenza Vaccine Uniflu
15881991|NCT03789539|Biological|Placebo|Placebo saline
15881992|NCT03789526|Procedure|ultrasound guidance|ultrasound guidance of tendon injection
15881993|NCT03789513|Diagnostic Test|HPV test with partial genotyping and VIA triage|HPV testing with the GenXpert platform VIA Biopsies of VIA+ lesions or random Treatment with thermal ablation of women with precancerous lesions
15881994|NCT03789487|Device|Device programming of CRT pacemaker or defibrillator|Stimulation vector optimization then AV delay optimization in order to obtain the highest systolic blood pressure (SBP) by using the Finapress® NOVA noninvasive device
15881995|NCT03789474|Device|HUNTLEIGH FLOWTRON ACS900|
15881996|NCT03789461|Procedure|Fecal Microbiota Transplantation|FMT infusion (100-200ml) and Mucosal Microbiota Assessment (To assess the fecal and mucosal microbiota before and after FMT)
15881997|NCT03789448|Other|Early Access to ART for All|All HIV-positive individuals will be initiated on Swaziland's recommended first-line ART regimen, unless contraindicated when recommended alternate regimens will be used per national guidelines
15881998|NCT03789435|Diagnostic Test|Questionnaire|"A questionnaire from which the session dedicated to the evaluation of the stump pain, the phantom limb and the sensation of the phantom limb has been extracted will be administered: this is the Prosthetic Evaluation Questionnaire (PEQ) validated in Italian by Ferrero et al. 2005.
~In the questionnaire sent to patients will be asked also for anthropometric data (weight, height) in addition to the characteristics of the worn prosthesis and if they have followed a period of rehabilitation.The time of use of the prosthesis will be evaluated through the Houghton Scale of Prosthetic Use in People with Lower- Extremity Amputations (19)"
15881999|NCT03789422|Drug|association of levocetirizine and tranexamic acid|levocetirizine 10 mg/day + tranexamic acid 2 g/day
15882000|NCT03789422|Drug|Levocetirizine only|levocetirizine 20 mg/day
15882001|NCT03789409|Dietary Supplement|Intermittent Fasting|The aforementioned intermittent fasting in arm/group descriptions.
15882002|NCT03789396|Other|Targeted Normoxia (oxygen saturation 90-96%)|The intervention (post-implementation) group will be trauma patients admitted to the ICU during the 6 months after the targeted normoxia implementation
15882003|NCT03789396|Other|Usual Care Oxygenation|The control (pre-implementation) group will be trauma patients admitted to the ICU during the 12 months prior to the targeted normoxia implementation
15882004|NCT03789370|Drug|Propofol|Maintanance of general anaesthesia with propofol
15882005|NCT03789370|Drug|Sevoflurane|Maintainance of general anaesthesia with sevoflurane.
15882006|NCT03789357|Diagnostic Test|Aldosterone renin ratio|Aldosterone Renin Ratio to screen for Primary Aldosteronism
15882007|NCT03789344|Other|acupuncture|Acupuncturists apply the seven-days' electro-acupuncture treatment on the acupoints of Neiguan points and Daling points for 30min per day.
15882008|NCT03789344|Other|Psychotherapy|Subjects in psychotherapy group would be accepted 20mins- psychotherapy per day.
15882009|NCT03789344|Other|blank control|Blank control subjects would be observed only during this investigation.
15882010|NCT03789331|Other|Anogenital distance measurement|"The women were kindly asked to lay down in the lithotomy position with their thighs at 45° to the examination table. A digital caliper (Mitutoyo 500-752-10 ABSOLUTE Digimatic Coolant Proof Caliper 0-150mm / 0-6, Mitutoyo Corporation, Japan) was used to measure anogenital distance.
~Anogenital distance anus to clitoris: will be measured in centimeters from the anterior clitoral surface to the center of the anus.
~Anogenital distance anus to fourchette: will be measured in centimeters from the posterior fourchette to the center of the anus.
~Two investigators who were blind to the gynecological status of the women will measure each distance three times, and the mean value of the six measurements of each anogenital distance will be used."
15882011|NCT03789318|Drug|CA-008|Each cohort will use 5, 10, or 15mg CA-008 reconstituted in saline.
15882012|NCT03789318|Drug|Placebo|Each cohort will use placebo reconstituted in saline.
15882013|NCT03789292|Biological|CT-P17 SC|Subcutaneous injection of Adalimumab 40mg every two weeks
15882014|NCT03789292|Biological|Humira SC|Subcutaneous injection of Adalimumab 40mg every two weeks
15882015|NCT03789266|Procedure|drain ablation|drain ablation will be done in Aspiration mode or in non Aspiration mode
15882018|NCT03789227|Procedure|ganglion impar block|the patient will be in the prone position with a pillow under the abdomen The pre-injection planning images will be obtained using CT with 2 mm axial section thickness. Under aseptic technique, a skin wheal will be raised with 2 ml lignocaine 0.5% using 23 G needle either in midline or paramedian approach. After identifying the ganglion impar, usually at the level of the sacro-coccygeal disc, a 25 G, 9 cm long spinal needle will be introduced at approximately 6-9 cm from midline and a small amount of non-ionic contrast medium (0.5 ml iopamidol; 300 mg/ml) will be injected. The midline approach may be selected according to patient position and operative condition. In the midline approach the sacro-coccygeal disc is identified and needle will be introduced perpendicular through the disc and just encroaching upon presacro-coccygeal space. Thereafter, 3 ml lidocaine 2% will be injected, three minutes later 5 ml absolute alcohol 95%.
15882019|NCT03789214|Drug|Placebo oral capsule|Placebo Sleep Medication
15882023|NCT03789201|Device|TMS fMRI|compare measurements to established functional connectivity measures; e.g., EEG coherence and fMRI
15882024|NCT03789175|Dietary Supplement|Nicotinamide Riboside (NR)|Niacin is a form of vitamin B3 and has been used to treat hypercholesterolemia for many years. There is growing evidence that nicotinamide adenine dinucleotide (NAD+ can maintain mitochondria through various mechanisms and that it is possible to improve mitochondrial function by dietary supplementation with the vitamin B3 analogue nicotinamide riboside (NR), an intermediate in the NAD+ salvage pathway. We have observed that culturing the fibroblasts of a LFS patient with mitochondrial deficiency in medium containing NR rescues the defect in mitochondrial respiration.
15882025|NCT03789149|Radiation|Intraoperative Radiotherapy|Intraoperative Radiotherapy with a mobile device (Intrabeam, Carl Zeiss AG) consisting of a small source of low energy x-rays (30-50 kV) mounted on a mechanical arm with six degrees of freedom. The resulting dose distribution is isotropic around the tip of the X-ray source. A set of spherical applicators with diameters ranging from 1.5 to 5 cm is available to connect to the source. The treatment time may vary from 20-30 minutes with the suggested dose of 18 Gy to the resection cavity to a depth of 1 mm.
15882026|NCT03789136|Other|Not applicable, observational study|Not applicable, observational study
15882027|NCT03789123|Drug|Estradiol valerate/dienogest|The effects of drugs given for endometrioma and contraception will be observed on ovarian reserve, endometrioma size and pain score.
15882028|NCT03789110|Drug|Nivolumab|Nivolumab is called an anti- PD-1 or a checkpoint inhibitor and is an antibody (a type of human protein) designed to allow the body's own immune system to destroy tumors
15882029|NCT03789110|Drug|Ipilimumab|Ipilimumab is called an anti-CTLA-4 and is a type of antibody that works to prevent the body's immune system from stopping to fight a specific cancer
15882034|NCT03789084|Behavioral|Brief Cognitive-Behavioral Therapy for Health Anxiety|4-session in-person 45-minute psychotherapy sessions focused on building motivation for change, psychoeducation, cognitive restructuring, and situational and interoceptive exposure to health-related fear stimuli.
15882035|NCT03789084|Behavioral|Referral to mental health provider|Provider makes a referral to a mental health provider in the outpatient psychiatry clinic or a community provider of the participant's choice.
15882036|NCT03789071|Diagnostic Test|External ultrasound evaluation of the airway|Patients scheduled to have surgery under general anesthesia in whom tracheal intubation is planned, will have a clinical and ultrasound assessment of the airway before surgery. Information regarding laryngoscopy in the operating room will be recorded.
15882037|NCT03789058|Drug|Ibuprofen 400 mg|Surgical removal of wisdom teethb with different regimen of Ibuprofen frequency ; three times versus two times .
15882038|NCT03789045|Diagnostic Test|Metabolic thresholds and fat oxidation points relationship|Investigators aim to determine exercise intensity (expressed in ml/kg/min of VO2) at which metabolic thresholds and fat oxidation points occur by using non-invasive breath-by-breath gas analysis during either graded treadmill or cycle ergometry test (2min stages and 1km/h or 50 W load increase) till exhaustion to determine maximal oxygen uptake (VO2max), with gases being collected at the mouth level. The strength of the relationship between AeT and at FATmax will be assessed using the Pearson product moment (r) correlation coefficient with same being done for AnT and FATmin correlation. A coefficient of determination (R2) will be used to detect the proportion of existing variance. A paired t-test will be used to asses' differences between measured variables.
15882039|NCT03789032|Drug|Vadadustat|Vadadustat 300 mg
15882040|NCT03789032|Drug|Rabeprazole|Oral Rabeprazole
15882041|NCT03789019|Drug|BP-C1|BP-C1, 0.05% solution for injection; doses: 0.035 mg/kg body weight (0.07 mL/kg) intramuscularly once daily for 32 consecutive days
15882042|NCT03789006|Drug|Antithymocyte Immunoglobulin (Rabbit)|Induction agent for living donor kidney transplantation
15882043|NCT03789006|Drug|Interleukin 2 Receptor Antagonist|Induction agent for living donor kidney transplantation
15882048|NCT03788967|Drug|Tebipenem Pivoxil Hydrobromide (TBPM-PI-HBr)|Antibiotic Therapy for Complicated Urinary Tract Infection
15882049|NCT03788967|Drug|Ertapenem|Antibiotic Therapy for Complicated Urinary Tract Infection
15882086|NCT03788629|Other|Subtalar joint MWM mobilization|There were two groups for this study. In addition to treatment of control group, subtalar joint mobilization was performed.
15882050|NCT03788954|Other|Kinesiotaping|Kinesio tape (KT) is the original elastic adhesive tape for injury prevention, rehabilitation, and performance enhancement. Kinesio Tape is latex-free, hypoallergenic and wearable for days at a time. It has been shown to be clinically effective in joint range of motion promotion,increasing muscle activity and functional performance.
15882051|NCT03788941|Procedure|left atrial appendage closure and catheter ablation|"Left atrial appendage closure (LAAC) is a treatment strategy to reduce the risk of left atrial appendage blood clots from entering the bloodstream and causing a stroke in patients with non-valvular atrial fibrillation (AF).
~Catheter ablation is a procedure used to remove or terminate a faulty electrical pathway or pathological sites from sections of the hearts of those who are prone to developing cardiac arrhythmias such as atrial fibrillation, atrial flutter, supraventricular tachycardias (SVT) and Wolff-Parkinson-White syndrome (WPW syndrome). The ablation procedure can be classified by energy source: radiofrequency ablation and cryoablation."
15882052|NCT03788928|Diagnostic Test|serum mitochondrial DNA|serum mitochondrial DNA will be measured using RT-PCR within first 72 hours of symptoms of acute pancreatitis
15882053|NCT03788915|Behavioral|Online dietetic lifestyle counseling|"The certified clinical dieticians provide individual therapy online and offline according to their patients' needs and based on information supplied via the website www.livalife.dk. The dietician generates a daily caloric reduction plan of approximately 1600-4800 KJ based on the patients' diet record. The dietary advice will be standardized and follow the dietary guidelines given at www.livalife.dk and the Danish Health Administration (Sundhedsstyrelsen)."
15882054|NCT03788915|Behavioral|Usual care|Patients randomized to the control group will be offered to receive usual municipal secondary or tertiary preventive offers.
15882055|NCT03788902|Drug|Ritalin|Single dose of Ritalin IR 0.3-0.5 mg/kg OR placebo
15882056|NCT03788889|Drug|Ketamine|Ketamine infusion
15882057|NCT03788889|Drug|Phenobarbital|Phenobarbital intravenous injection
15882058|NCT03788889|Drug|Lorazepam|Standard of Care
15882059|NCT03788889|Drug|Placebo A|Placebo injection
15882060|NCT03788889|Drug|Placebo B|Placebo infusion
15882061|NCT03788876|Other|Neuromuscular electrical stimulation|The NMES training will be applied once a day (30 minutes of application per session with an increase of one minute every two days and reduction in the OFF time), until the discharge from the ICU. The patient will continue with the application also in the Hospitalization Units of HCPA and Irmandade da Santa Casa de Misericórdia de Porto Alegre until discharge.
15882062|NCT03788876|Other|Conventional care|Physiotherapy protocol will be performed by HCPA and Irmandade da Santa Casa de Misericórdia de Porto Alegre physiotherapists twice a day, which will consist of exercises for bronchial hygiene, exercises for pulmonary reexpansion, and passive mobilization exercises.
15882063|NCT03788863|Drug|Diflucortolone valerate (BAY866146)|Follow clinical administration
15882064|NCT03788837|Drug|Ilomedin|The patient will receive treatment with intravenous Ilomedin therapy at a dose of 0.5ng/kg/min with increments of 0.5 ng/kg/min every 30 minutes up to a maximum posology of 1,5 ng/kg/min for 48h.
15882065|NCT03788837|Drug|NaCl|The patient will receive treatment with intravenous NaCl 0.9% (placebo-double blinded) with increments of infusion rate every 30 minutes for 48h
15882066|NCT03788811|Device|ERG assessment (RSPA)|Processing and analysis of retinal signals
15882067|NCT03788798|Device|Patient infotainment system|The patient infotainment system is a quasi-interactive computer program connected to a server that pushes messages and educational programs ordered from the caring physicians or on-demand by the patients. The server has parallel data exchange gateways to the Hospital Information System (HIS), Picture Archiving Communication System (PACS), and can record the patients' responses to surveys and questionnaires.
15882068|NCT03788785|Behavioral|Experimental arm|The specific tobacco cessation intervention will be based on meeting with trained nurses : three 1/2 hour session of assessment of current addictive behaviors and motivation to change smoking habits occurring within five days tops.
15882069|NCT03788785|Other|Control arm|In the control arm, patients will receive the current standard of care for these patients, namely referral to external care after general advice on tobacco cessation (self-help tools).
15882070|NCT03788772|Other|Multiple blood sampling|ICU septic and non-septic patients will be subjected to repeated blood samples at the following time-points: ICU admission, day 4/5, ICU and hospital discharge, 3 months. Patients exhibiting ICU-acquired infection will also be sampled at the time of diagnosis (up to 6 additional blood samples of 20 mL within 3 months = 120mL)
15882071|NCT03788772|Other|Simple blood sampling|Healthy controls (blood donors and patients undergoing elective cataract surgery) will be subjected to one single blood sample of 20 mL.
15882072|NCT03788759|Drug|Alpha-lipoic acid|Administration of ALA (100 mg/day) for 4 months, as an adjunct to antipsychotic medication.
15882073|NCT03788759|Drug|Placebo Oral Tablet|Administration of placebo, as an adjunct to antipsychotic medication.
15882074|NCT03788733|Drug|Melatonin 3 mg|1 time a day for 8 weeks
15882075|NCT03788733|Drug|Placebo Oral|1 time a day for 8 weeks
15882076|NCT03788720|Procedure|Suture of the ovarian cortex|Suture of the ovarian cortex after laparoscopic enucleation of endometriomas, using one single monofilament suture material, continuous suture technique with maximum 5 transfixion of the ovarian cortex and intracorporeal knots only (no extracorporeal knots).
15882077|NCT03788720|Procedure|No suture of the ovarian cortex|Laparoscopic enucleation of endometriomas without suture of the ovarian cortex
15882078|NCT03788707|Other|Passive leg raising|After 30 seconds of lying flat, volunteers will have passive leg raising to 45 degrees. Expired CO2 will be measured via a face mask before and after leg raising.
15882079|NCT03788694|Drug|Ketamine|8 doses of intranasal ketamine; 40 mg per dose.
15882080|NCT03788681|Drug|Estradiol Valerate|"oral estradiol  estradiol valerate  (Cyclo-Progynova)"
15882081|NCT03788681|Drug|Placebo Oral Tablet|placebo
15882082|NCT03788668|Procedure|Hyoid suspension|Hyoid suspension will be done with barbed reposition pharyngoplasty
15882083|NCT03788642|Procedure|Control LED shoe arm|Patients with DFU will wear LED shoe 30 minutes once daily
15882084|NCT03788642|Procedure|Laser Shoe arm|Patients with DFU will wear Laser shoe 30 minutes once daily
15882085|NCT03788629|Other|Talocrural joint MWM mobilization|There were two groups for this study. In addition to Bobath Concept, talocrural joint mobilization was performed.
15882087|NCT03788616|Drug|Fuji IX EXTRA|High-viscosity glass ionomer (Fuji IX EXTRA)
15882088|NCT03788616|Drug|ACTIVA KIDS bioactive restorative material|Modified composite (ACTIVA KIDS)
15882089|NCT03788603|Drug|Rogaratinib (BAY1163877)|Rogaratinib will be administered on 20 days in Cycle 1 (single dosing on Day 1 and twice daily dosing on Days 3-21). In Cycles ≥2, rogaratinib will be administered twice daily for 21 days, with cycles repeated every 21 days. Treatment will be continued until death, tumor progression, unacceptable toxicity, consent withdrawal, or until another criterion is met for withdrawal from the study at the discretion of the investigator.
15882090|NCT03788590|Device|Jenscare TAVI|Jenscare TAVI and delivery system will implant a percutaneous bioprosthesis value, which is positioned in the native aortic valve, plays a role to control blood flow, and help your heart to work better. It may also shorten your recovery time to getting back to everyday activities.
15882091|NCT03788577|Dietary Supplement|Oligonol intake|Major intervention of Oligonol component , as suggested Oligonol safe dose for adults is 200mg per day.
15882092|NCT03788577|Dietary Supplement|Placebo|Placebo
15882093|NCT03788538|Drug|dexmedetomidine|10 minutes before anesthesia induction, all patients were administrated with dexmedetomidine 1 μg/kg/min.At the beginning of induction, dexmedetomidine was changed to corresponding maintenance dose in each group.
15882094|NCT03788525|Behavioral|Reduced recreational screen time|Participants must remove all recreational screen-based media use beyond 3 hours/week. This includes all recreational screen-based media use inside and outside the household. As a tool to comply with the intervention the families will hand-over all portable screen-based media devices. In return, each participant who own a smartphone will receive a regular cell-phone which can only make phone calls and send text messages. For a maximum of ½ an hour a day, adult participants may use this device for necessary contact. The families are allowed a maximum of 3 hours/week of recreational screen time. If participants can not hand over their smartphones due to daily use for work purposes we will install an app tracking screen use on these devices.
15882095|NCT03788525|Behavioral|Timed recreational screen time|Participants must remove all recreational screen-based media use after 6 PM. There are no restrictions on the amount of screen-based media use before 6 PM. Thus, before 6 PM, the participants must continue their habitual screen-based media use completely. However, after 6 PM, both work-related and recreational screen-based media use must be removed completely.
15882096|NCT03788512|Other|observational only- no intervention|observational only- no intervention
15882097|NCT03788499|Other|Massage of Maxillofacial and Oral Cavity|Massage of Maxillofacial and Oral Cavity is performed five times a day, each part lasts 1-2 minutes, repeating 3 cycles. The maxillofacial and oral massage last from the first day of radiotherapy to three months after last radiotherapy.
15882098|NCT03788486|Device|2-3 Joule LED blue light device|application of blue light LED light device for 2 minutes in the central lower lids, temporal lower lids and upper temporal lids twice weekly under observation for one month
15882099|NCT03788460|Other|no intervention|no intervention
15882100|NCT03788447|Other|High end-tidal CO2|maintaining of end-tidal CO2 with the range of 40-45 mmHg
15882101|NCT03788447|Other|Low CO2 group|maintaining of end-tidal CO2 with the range of 30-35 mmHg
15882102|NCT03788434|Drug|VE303|VE303 is a live biotherapeutic product containing 8 clonal human commensal bacterial strains manufactured under GMP conditions.
15882103|NCT03788434|Drug|Placebo|Placebo capsules contain micro-crystalline cellulose. They are visually identical to VE303 capsules. They will be taken by mouth for 14 days. Placebo capsules will not contain any VE303 Drug Product.
15882104|NCT03788421|Device|LIGASURE|Electricity based cautery tool used during both laparoscopic and open surgery for optimal hemostasis.
15882105|NCT03788421|Procedure|Clamping and suturing|Step by step clamping and suturing of the mesosalpinx until achievement of total salpingectomy.
15882106|NCT03788408|Behavioral|Intensive Psychotherapy and case management for refugee trauma|CVT's approach emphasized active interdisciplinary coordination and a relational focus anchored in cultural humilityX to address survivors' priorities, empower survivors as the primary architects of their healing, and work alongside each survivor to co-construct meaning and behavioral change.
15882107|NCT03788395|Device|Symbicort Turbohaler plus Turbo+|Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) plus Turbo+ for three months.
15882108|NCT03788395|Drug|Symbicort Turbohaler without Turbo+|Symbicort Turbohaler (Budesonide and Formoterol Fumarate Dihydrate) without Turbo+ for three months.
15882109|NCT03788369|Procedure|Hybrid Coronary Revascularization|Hybrid coronary revascularization (HCR) combines minimally invasive surgical coronary artery bypass grafting of the left anterior descending artery with percutaneous coronary intervention (PCI) of non-left anterior descending vessels.
15882110|NCT03788356|Device|Inspiratory muscle training|Inspiratory muscle training with a device
15882111|NCT03788356|Other|Diaphragmatic breathing|Diaphragmatic breathing exercise
15882112|NCT03788343|Dietary Supplement|Phenylalanine|The study product Phenylalanine, a dietary supplement, is authorized in Switzerland, but not designated for this patient group.
15882113|NCT03788343|Drug|Placebo|Placebo capsules are indistinguishable in their appearance from Phe capsules
15882114|NCT03788330|Device|Fresh air system with filtration|Using fresh air ventilation combined with PM2.5 filtration system to reduce the indoor PM2.5 concentration in primarty school classrooms
15882115|NCT03788317|Drug|Botulinum toxin type A|Injections to hypertonic muscles
15882116|NCT03788304|Device|non-invasive ventilation|conventional NIV
15882117|NCT03788304|Device|high flow nasal cannula|HFNC ventilation
15882118|NCT03788291|Drug|Acalabrutinib|100 mg by mouth twice a day starting on day 8 of cycle 1
15882119|NCT03788291|Drug|Rituximab|Administered 2 times weekly for 6 cycles. Initial dose day 1: 50 mg IV, then 50 mg SQ thereafter.
15882120|NCT03788278|Device|BioBeat|The watch incorporates sensors, a battery, a software system, memory components, and a communications component. the watch will be worn 24 hours a day, 7 days a week.
15882121|NCT03788265|Device|Lipogems|harvest and inject micro-fragment adipose tissue
15882122|NCT03788252|Drug|Renamezin|7 capsules once, three times a day, for 48 weeks
15882202|NCT03787550|Drug|The Sedatives, analgesics and antibiotics|The sedatives (dexmedetomidine, midazolam, propofol), analgesics (butorphanol, remifentanil, sufentanil), and six antibiotics (linezolid, voriconazole, tigecycline, teicoplanin, caspofungin and meropenem) will be used according to the clinical need.
15891001|NCT03719456|Procedure|Retrograde Intrarenal Surgery|
15882123|NCT03788239|Other|Staples versus sutures|"Prolene suture: non-absorbable, sterile surgical suture composed of an isotactic crystalline steroisomer of polypropylene, a synthetic linear polyolefin. After completion of the procedure, deep tissues will closed with subcuticular prolene suture. Compared to the absorbable sutures, prolene is known to cause less infection since it is a monofilament material.
~Staples: specialized staples used in surgery in place of sutures to close skin wounds. After completion of the procedure, deep tissues were closed with absorbable braided suture, then the skin will be closed by staples."
15882124|NCT03788226|Drug|POF|A 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and leucovorin (400 mg/m2), administered simultaneously over a 2-hour infusion period. Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating every 14 days for 12 cycles.
15882125|NCT03788226|Drug|CAPOX/SOX/FOLFOX|"CAPOX: IV oxaliplatin given over 120 min at a dose of 130 mg/m2 on day 1, oral capecitabine 1000 mg/m2 twice daily on days 1 through 14 every 21 days for 8 cycles.
~SOX: Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO [BSA <1.25 40mg bid (total 80mg/day); BSA ≥1.25 - <1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)], divided by two on D1-14 every 21 days for 8 cycles.
~mFOLFOX6: IV oxaliplatin given over 120 min at a dose of 85 mg/m2 on day 1 followed by IV leucovorin 400 mg/m2 over 2h, IV bolus 5-Fluorouracil 400 mg/m2 and IV infusional 5-Fluorouracil 2400 mg/m2 over 46h every 14 days for 12 cycles."
15882126|NCT03788213|Radiation|3 week RT|40 Gy in 15 fractions over 3 weeks to the whole breast or chest wall. Patients undergoing breast conservation therapy will receive additional boost radiotherapy to the tumor bed. The supraclavicular fossa will be treated in patient with node positive disease or those receiving neoadjuvant chemotherapy. IMC and Axillary radiotherapy will be given as per the institutional policy. Boost Dose schedule for BCS patients will be 8 Gy delivered in 15 fractions simultaneously with tangential EBRT. In institutions planning for sequential boost, a dose of 12 Gy in 4 fractions will be delivered after whole breast EBRT.
15882127|NCT03788213|Radiation|1 week RT|26 Gy in 5 fractions over 1 week to the whole breast or chest wall. Treatment volumes will be same as the control arm. Additional boost will be delivered to patients who have undergone breast conservation. Boost Dose schedule for BCS patients will be 6 Gy delivered in 5 fractions simultaneously with tangential EBRT. In institutions planning for sequential boost, a dose of 12 Gy in 4 fractions will be delivered after whole breast EBRT.
15882128|NCT03788200|Procedure|Bracing|Treatment arm #1 (8 weeks of post-injury bracing with rigid cervical collar): Participants randomized to this treatment arm will be treated with 8 weeks in a rigid cervical collar.
15882129|NCT03788200|Procedure|posterior C1-C2 instrumented fusion|Treatment arm #2 (posterior C1-2 instrumented fusion): Participants randomized to this treatment arm will undergo posterior C1-2 instrumented fusion with either local bone grafting or autologous iliac crest bone grafting with or without allograft bone grafting. Bone grafting decision will be made by the treating surgeon. All remaining decisions surrounding medical and surgical care will be made by the attending spine surgeon involved in each case.
15882130|NCT03788187|Other|Blood test sample|
15882131|NCT03788187|Other|Peritumoral adipose tissue sample|
15882132|NCT03788174|Drug|Apatinib|Apatinib (500 mg qd p.o.) until disease progression or intolerable toxicity or refused by the patients.
15882133|NCT03788174|Drug|POF|The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days.
15882134|NCT03788161|Other|Real Virtual Reality|Participants will receive a distraction by playing a game of virtual reality with a 3D application
15882135|NCT03788161|Other|Placebo Virtual Reality|Participants will receive a placebo distraction with a game of virtual reality with a 3D application without functioning
15882136|NCT03788148|Device|Stent, red blood cell transfusion|BMS (Bare Metal Stent) and DES (drug-eluting stent) transplants with periprocedural red blood cell transfusion
15882137|NCT03788135|Behavioral|cooling|the participants in the experimental group will receive a cold pack (gel pack, temperature -6 degrees to -12 degrees Celsius) will be placed on the target muscles for 20 minutes.
15882138|NCT03788122|Other|In-depth interview|The 'intervention' administered to this group of participants are two or three in-depth interviews (average 30-60 m minutes per interview) on their experiences, views, feelings and thoughts (perceptions) regarding acceptability of the fetal surgery.
15882139|NCT03788109|Procedure|device: combined solid state HRiM|The HRiM catheter (Medical Measurement Systems, Enschede, The Netherlands) incorporating 36 pressure sensors, spaced at 2 cm in the stomach and esophagus and at 1 cm in the LES and upper esophageal sphincter (UES), and 16 impedance channels throughout the esophagus, will be placed transnasally, after topical anesthesia. Manometry will be used to record pressures in the stomach, the esophagus, the LES and the UES. In this way, it is possible to detect and characterize TLESRs, and to measure GA. The impedance channels will be used to measure bolus movement, and thus to detect and characterize gastro-esophageal reflux.
15882140|NCT03788096|Behavioral|Peer Support with Motivational Interviewing|Mentors will trained in motivational interviewing and will conduct weekly telephone calls with participants randomized to the PS-PICS peer support intervention arm.
15882141|NCT03788096|Behavioral|Usual Care Group|Usual care.
15882142|NCT03788083|Drug|Trimix|Intratumoral TriMix injection
15882143|NCT03788083|Drug|Placebo|Intratumoral placebo injection
15882144|NCT03788057|Other|ICS dose reduction|"If control of symptoms is maintained (evaluation based on clinical symptoms solely), every 3 months the dose of ICS is halved according to GINA guidelines, until the control is lost or the lowest daily dose is reached (200 mcg, calculated as budesonide equivalent).
~In the case of loss of asthma control, beta-mimetic will be administered (temporarily) and return to the chronic administration of the previous, twice higher dose of ICS is restored (or further increase of treatment). In severe exacerbations, inclusion of oral steroids will be considered."
15882145|NCT03788044|Other|Education|Education + Medication adherence monitoring + Feedback when low adherence
15882146|NCT03788031|Other|Acuity training|The intervention will be a vision therapy. On each trial, a properly oriented stimulus will be presented randomly at one of the four locations on a flat monitor screen. The visual task is to identify the location of the stimulus.
15882147|NCT03788031|Other|Occlusion therapy|Participants will be required to patch the good eye for 20 days, 1 hour per day.
15892381|NCT03709290|Radiation|mri|mri brain & spinal cord
15882148|NCT03788018|Drug|lidocaine and dexmedetomidine IV|Patients received IV bolus infusion of lidocaine (2%) 1.5 mg/kg and dexmedetomidine 0.5 µg/kg diluted with normal saline to 20 ml in the LD group respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion at rate of lidocaine 1.5 mg/kg and dexmedetomidine 0.4 µg/kg made up to 20 mL every hour until 30 min before the end of operation, respectively.
15882149|NCT03788018|Drug|saline IV|Patients received 20 ml normal saline and 20 ml normal saline in the CON group respectively, over 10 minutes before induction of anesthesia, followed by a continuous IV infusion 20 ml normal saline and 20 ml normal saline every hour until 30 min before the end of surgery
15882150|NCT03788005|Procedure|Early mobilization|Early mobilization as soon as possible and within a maximum of 12 hours following burr hole craniostomy for chronic subdural hematomas.
15882151|NCT03787992|Drug|Alflutinib Mesylate (AST2818) 80mg//40 mg+ placebo|"The initial dose of AST2818 80 mg once daily can be reduced to 40 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment.
~Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria."
15882152|NCT03787992|Drug|Placebo Gefitinib 250 mg|The initial dose of Placebo Gefitinib 250 mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
15882153|NCT03787992|Drug|Gefitinib 250 mg|"The initial dose of Gefitinib 250mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment.
~Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria."
15882154|NCT03787992|Drug|Placebo AST2818 80mg//40 mg|The initial dose of Placebo AST2818 80 mg once daily can be reduced to Placebo AST2818 40 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
15882155|NCT03787979|Other|Lumbopelvic stiffening technique|"Participants will stretch their hamstrings muscle in standing position with lumbopelvic stiffening technique. Fifteen percent of the body weight will be used to standardize stretching force. During stretching protocol, the participants will be instructed to face the hydraulic table with their hips square, maintain trunk straight up and look straight ahead. Researcher commands during adjusting the bed up, please tense your back rigid. After that, hydraulic bed will be lifted up until force reaches 15 percent of the body weight. Participant will perform 30 seconds/repetition for 4 repetitions with 15 seconds rest between repetitions."
15882156|NCT03787979|Other|Lumbopelvic relaxing technique|"Participants will be instructed to face the hydraulic table with their hips square, maintain trunk straight up and look straight ahead. The researcher commands During adjusting the bed up, please relax your back. The hydraulic bed will be lifted up until force reaches 15 percent of the body weight. Participant will perform 30 seconds/repetition for 4 repetitions with 15 seconds rest between repetitions."
15882157|NCT03787966|Other|ATOPE-B|Patients will perform therapeutic exercise before medical treatment and will follow the usual care after medical treatment.
15882158|NCT03787966|Other|ATOPE-I|Patients will follow usual care before medical treatment and will perform therapeutic exercise after medical treatment.
15882159|NCT03787953|Drug|Anti-PD-1/PD-L1 antibodies|The study is a real-world study. According to the actual medical history of patients, the usage of anti-PD-1/PD-L1 antibodies was collected.
15882160|NCT03787940|Drug|Isoniazid|standard dose isoniazid or high dose isoniazid for participants with rapid acetylators
15882161|NCT03787927|Drug|Autologous Platelet Transfusion (room-temperature-stored)|The participant will receive an autologous platelet transfusion of their room-temperature-stored platelets after 5 days of storage.
15882162|NCT03787927|Drug|Autologous Platelet Transfusion (cold-stored 5 days)|The participant will receive an autologous platelet transfusion of their cold-stored platelets after 5 days of storage.
15882163|NCT03787927|Drug|Autologous Platelet Transfusion (cold-stored 10 days)|The participant will receive an autologous platelet transfusion of their cold-stored platelets after 10 days of storage.
15882164|NCT03787927|Drug|Autologous Platelet Transfusion (cold-stored 15 days)|The participant will receive an autologous platelet transfusion of their cold-stored platelets after 15 days of storage.
15882165|NCT03787927|Drug|Aspirin|Aspirin (325mg) will be administered the day before every transfusion.
15882166|NCT03787927|Drug|Clopidogrel|Clopidogrel (600mg) will be administered the day before every transfusion.
15882167|NCT03787914|Procedure|Mobile Outreach Approach|TB patients in intervention arm were served by outreach mobile teams for DOTS (i.e. administration of anti-TB medicines orally at the place and time of their choice and convenience under mobile teams direct supervision
15882168|NCT03787901|Other|Morula Vitrification|Evaluating the ongoing pregnancy rate following Morula vitrification compared with Blastocyst Vitrification.
15882169|NCT03787875|Procedure|periodontal treatment|In the study group, periodontal scaling and root planning treatment of the 4 quadrants was performed for two consecutive weeks without the use of antiseptics or antibiotics, and the patients were instructed in oral hygiene, including both brushing techniques and proximal hygiene.
15882170|NCT03787849|Drug|Sevoflurane|All children will receive inhalation anesthesia with sevoflurane through facial mask in concentrations between 3-8% for anesthesia induction. After induction and peripheral vein puncture, the anesthesia will be maintained only with sevoflurane 3% until completion of the procedure.
15882171|NCT03787849|Drug|Propofol|All children will receive inhalation anesthesia with sevoflurane through facial mask in concentrations between 3-8% until lost of conscience and peripheral vein puncture. After that, sevoflurane will be turned off and its clearance will be analyzed through gas analyzer monitor. From here, anesthesia will be maintained as total venous with continuous propofol infusion 100 mcg.kg.min-1 until completion of the procedure.
15882172|NCT03787836|Behavioral|Maintained Exercise|"Complete 28 weeks of aerobic exercise, with one week (following week 16) for testing.
~Week 1 - 16 Intensity: 4.5 metabolic equivalents (METs).
~Duration:
~Week 1: 80 minutes Week 2: 100 minutes Week 3: 120 minutes Week 4: 135 minutes Week 5 - 16: 150 minutes/week
~Week 17: Physiological Testing
~Week 18 - 29 Intensity: 4.5 METs Duration: 150 minutes/week
~All exercise must be completed across a minimum of two sessions per week. Sub-maximal exercise tests will be completed every 4 weeks to adjust intensity."
15882173|NCT03787836|Behavioral|Increased Intensity|"Complete 28 weeks of aerobic exercise, with one week (following week 16) for testing.
~Week 1 - 16 Intensity: 4.5 metabolic equivalents (METs).
~Duration:
~Week 1: 80 minutes Week 2: 100 minutes Week 3: 120 minutes Week 4: 135 minutes Week 5 - 16: 150 minutes/week
~Week 17: Physiological Testing
~Week 18 - 29 Intensity: 6.0 METs Duration: 150 minutes/week
~All exercise must be completed across a minimum of two sessions per week. Sub-maximal exercise tests will be completed every 4 weeks to adjust intensity."
15882174|NCT03787823|Procedure|robotic Prostatectomy (RARP)|Modification of robotic Prostatectomy Arm A classic technique/ anterior transperitoneal RARP Arm B Transdouglas Technique/retzius-sparing RARP
15882175|NCT03787810|Diagnostic Test|Echocardiography|Echocardiography for assessment of left ventricular dysfunction
15882176|NCT03787797|Diagnostic Test|Echocardiography|Assessment of epicardial adipose tissue thickness
15882177|NCT03787784|Other|AI presentation|Automatic diagnosis information of AI is visible to endoscopist
15882178|NCT03787758|Drug|SAGE-718|SAGE-718
15882179|NCT03787745|Procedure|Ischemic postconditioning|After 60 seconds of reperfusion, ischemic postconditioning with an adequately sized balloon (60 reperfusion/60 seconds re-occlusion, four cycles) will be performed
15882180|NCT03787745|Procedure|Conventional|State of the art primary PCI, however thrombectomy is not allowed
15882181|NCT03787732|Drug|Fluid Bolus|500 milliliters of an intravenous crystalloid solution of the operator's choosing
15882182|NCT03787732|Other|No Fluid Bolus|No additional intravenous crystalloid administration initiated between randomization and two minutes after completion of endotracheal intubation
15882183|NCT03787719|Other|Twice per week dialysis|Twice-weekly 4 hour dialysis treatment
15882184|NCT03787706|Other|Dry Needling|Patients will receive dry needling over active trigger points in the upper trapezius muscle
15882185|NCT03787706|Other|Manual Therapy|Patients will receive a manual compression for 30seconds over active trigger points in the upper trapezius muscle
15882186|NCT03787693|Behavioral|VR - Virtual Reality|Subjects in the experimental group will perform the split-belt task in a VR environment
15882187|NCT03787680|Drug|Olaparib|300 mg by mouth twice a day for days 1-28 of a 28-day cycle.
15882188|NCT03787680|Drug|AZD6738|160 mg by mouth daily for days 1-7 of a 28-day cycle.
15882189|NCT03787667|Diagnostic Test|CT or MRI based Radiomics|Radiomic features were extracted from enhanced CT or MRI of colorectal cancer.
15882190|NCT03787654|Device|electroacupuncture|"BL33 and BL35 are inserted by needles of 0.30×75mm size till a depth of 60~70mm. SP6 is inserted by needle of 0.30×40mm size till a depth of 25-30mm. After manipulation and deqi sensation generation, the electrodes will be attached to the acupoints transversely with 20Hz continuous wave and an electricity current of 2mA-6.5mA at BL33 and BL35, and 1-3.5mA at SP6. The current is adjusted from zero to the degree where patients can tolerate.
~Subjects receive 3 sessions per week（every other day ideally) for 12 weeks, 36 sessions in total."
15882191|NCT03787654|Device|sham electroacupuncture|"In sham electroacupuncture group, sham acupoints 1 cun(≈15mm） horizontally outwardly lateral to BL33 and BL35, and 0.5 cun (≈10mm) horizontally behind SP6 are stimulated by needles of 0.30×40mm size. The needles are inserted to a depth of 2-3mm to stand still, without any manipulation and sensation of deqi. The electrodes will also be attached to needles with an electricity current of 0.1-0.3mA.
~The sessions will be the same as the electroacupuncture group."
15882192|NCT03787654|Drug|Solifenacin|Subjects take solifenacin 5-10mg per day for a succession of 36 weeks. The dose change is decided by doctors under a comprehensive consideration of side effects and Patient Global Symptom Control (PGSC), which is applied to evaluate the effectiveness of Solifenacin at the 4th, 8th, 12th and 24th week.The medicine can be discontinued at any time if the adverse effect is rather severe.
15882193|NCT03787641|Drug|Protamine Sulfate|Protamine Sulfate will be administered via an infusion pump to administer a 50 mg test doze, then 100 mg after 5 min waiting period. Following blood samples, additional alliquots of 50 mg will be measured to a maximum of 300 mg.
15882196|NCT03787615|Device|sipIT tools|Just in time drinking detection tools to promote increase fluid consumption
15882197|NCT03787602|Drug|KRT-232|KRT-232, administered by mouth
15882198|NCT03787589|Behavioral|Exercise Prescription|"Participants in the intervention group will be given an exercise prescription to increase their baseline steps by 1200 and 2000 steps per day at least 3 days a week over the first 3 months. If tolerated and accepted, the participants will increase their step counts by an additional 600 to 1000 steps per day at least 3 days a week for the next 3 months.This will be followed by a 6-month maintenance phase. The research coordinator will instruct the participants on the proper use of the Nordic walking poles which can be used to help participants achieve their prescribed number of steps.
~All participants will be encouraged to wear the pedometer throughout the trial in order to follow the step-count prescription and monitor adherence."
15882199|NCT03787576|Device|Cataract surgery|Evaluation of patient satisfaction after bilateral cataract surgery with multifocal intraocular lens implantation
15882200|NCT03787563|Drug|Herbal Tea|All participants will be given the intervention in an infusion tea bag. Participant will be instructed to take one tea bag three times a day at before breakfast, lunch and dinner meals. At the time of randomization both active and placebo infusion bag will be provided.There will be one day of washout period after 2 days on treatment.
15882201|NCT03787563|Drug|Placebo Tea|Similar looking inert placebo tea.
15882203|NCT03787511|Other|Cough assessment|Cough assessment with cough visual analog scale (VAS), and Leicester Cough Questionnaire (LCQ) for Diabetic patients with chronic cough and Diabetic patients without chronic cough
15882204|NCT03787511|Other|Neurological tests and cardiovascular tests|Neurological tests : electromyography, thermotest, QSAR + cardiovascular test for Diabetic patients with chronic cough and Diabetic patients without chronic cough
15882205|NCT03787511|Other|Skin biopsy|Skin biopsy to evaluate small fiber neuropathy for Diabetic patients with chronic cough and Diabetic patients without chronic cough
15882206|NCT03787498|Drug|PLX2853|Tablets
15882207|NCT03787485|Behavioral|LINKS|The primary aim of LINKS is to create community-clinical linkages between three community health centers and their respective county health departments in southern Arizona. This study will also develop and evaluate a chronic disease and emotional well-being intervention that will connect clinic patients to community-centered, county-delivered, community health worker programs.
15882208|NCT03787472|Device|JJV Investigational senofilcon A Multifocal Lens1|CONTROL
15882209|NCT03787472|Device|JJV Investigational senofilcon A Multifocal Lens2|TEST
15882210|NCT03787459|Drug|Arbidol|Oseltamivir plus Arbidol will be administrated from Days 1-7.
15882211|NCT03787459|Drug|Placebos|Oseltamivir plus placebos will be administrated from Days 1-7.
15882212|NCT03787433|Device|ARC - Assisted Rehabilitation Care|"ARC is a platform based on wearable inertial sensors and machine learning algorithms, designed to bring the rehabilitation at post-stroke patients' home, following hospital discharge.
~The product has been created with the purpose to improve physical skills and patient independence accordingly, in the six months following the acute event. ARC aims to optimize, ease and make more accessible the path of post-stroke rehabilitation during post-acute phase, in real life settings."
15882213|NCT03787420|Other|communication system|"We will use the questionnaire Amyotrophic Lateral Sclerosis Supportive Care Needs ,Amyotrophic Lateral Sclerosis Specific Quality of Life Instrument-Revised, Beck Depression Inventory and Caregiver Burden Scale."
15882214|NCT03787407|Behavioral|stress management and meditation|mindfulness training using mobile application
15882215|NCT03787394|Other|adding taste enhancer|Comparing sensory profiles of food products either enriched with FAAA-conjugates or plain
15882216|NCT03787381|Device|Ultrasound|Vaginal ultrasound examination
15882217|NCT03787368|Drug|BAY1213790|Single intravenous infusion of BAY1213790 (Two different doses)
15882218|NCT03787368|Drug|0.9% sodium chloride solution|Single intravenous infusion of Placebo (0.9% sodium chloride solution)
15882219|NCT03787355|Combination Product|Morse connection Implants|2 neighboring morse connection Implants of Zinedent - Strauman
15882220|NCT03787342|Procedure|Double Flap Incision|A full-thickness crestal incision will be made over the edentulous ridge, and then one partial-thickness vertical incision will be made on the buccal side. A partial-thickness flap will be raised first to separate the mucosal layer from the overlying periosteum. Subsequently, the periosteal layer will be elevated to expose the underlying alveolar process. Xenograft and Ti-mesh will be used to augment the defective site then periosteal flap will be sutured first, with periosteal sutures securing the regenerative site. Then the mucosal flap will be closed.
15882221|NCT03787342|Procedure|Modified Periosteal Releasing Incision|"A full-thickness muco-periosteal flap is reflected on the buccal side (crestal incision and two vertical releasing incisions). Near the base of mucoperiosteal flap, the periosteum is incised less than 0.5mm in depth, creating two segments, coronal segment and apical segment, of the periosteal flap. The shallow incision helps in preventing damage to the submucosal layer. The flap is pulled with a pair of periodontal forceps laterally. Subsequently, the lateral stretching of the coronal segment of the flap is performed by applying pressure using the blunt face of scalpel blade with sweeping motion to allow flap advancement."
15882222|NCT03787342|Procedure|Coronally Advanced Lingual Flap|A full-thickness crestal incision will be performed in the keratinized tissue from the distal surface of the more distal tooth to the retromolar pad. The flap design will be continued intrasulcularly on both vestibular and lingual sides of the mesial portion of the flap, buccally, it will be finished with a vertical releasing incision. On the lingual side, a full-thickness mucoperiosteal flap will be elevated until reaching the mylohyoid line. Then, using a blunt instrument it will be localized a connective tissue band continuing with the epimysium of the mylohyoid muscle. The blunt instrument will be inserted below this connective band, and, with gentle traction in the coronal direction, this muscular insertion will be detached from the lingual flap.
15882223|NCT03787342|Procedure|Periosteal releasing incision|
15882224|NCT03787329|Other|Core decompression surgery with bone marrow concentration|Core decompression surgery with bone marrow concentration
15882225|NCT03787329|Other|Core decompression surgery|Core decompression surgery only
15882226|NCT03787316|Device|Study group|4 weeks of custom-made insoles in the home and outside the home environment , follow the home exercise program during this process.It is planned to perform gait parameters and pain assessment before and after the treatment.
15882227|NCT03787303|Drug|Triiodothyronine (T3)|Participants will have their L-thyroxine (T4) discontinued and Triiodothyronine (T3)/liothyronine sodium initiated at 3: 1 and titrated.
15882228|NCT03787290|Drug|Tocilizumab|participants will receive a single subcutaneous injection of tocilizumab (162 mg)
15882229|NCT03787290|Drug|Placebo|participants will receive a single subcutaneous injection of saline
15882230|NCT03787290|Device|Whole-Body Hyperthermia|subjects' core temperature will be increased to 38.5 degrees Celsius (typically 60-120 minutes) then they will begin a 60-minute cool-down phase
15882231|NCT03787264|Drug|Bendamustine|Debulking: Cycles 1-2: d1+2 - 70mg/m² i.v.
15882232|NCT03787264|Biological|Obinutuzumab|"Induction: Cycle 1: d1 - 100 mg, d1 (or d2) - 900 mg, d8 + d15 - 1000 mg i.v.; Cycle 2 - 6: 1000 mg, d1 i.v.
~Maintenance: Cycle 1 - 8: 1000 mg, d1 i.v."
15882233|NCT03787264|Biological|Acalabrutinib|"Induction: Cycle 1: --; Cycles 2 - 6: d1-28: 2 x 100mg p.o.
~Maintenance: Cycle 1 - 8: d1-84: 2 x 100mg p.o."
15882234|NCT03787264|Biological|Venetoclax|"Induction: Cycles 1 + 2: --; Cycle 3: d1-7: 20mg, d8-14: 50mg, d15-21: 100mg, d22-28: 200mg p.o.; Cycle 4 - 6: d1-28: 400 mg p.o.
~Maintenance: Cycle 1 - 8: d1-84: 400 mg p.o."
15882235|NCT03787251|Drug|Apatinib|It is recommended that the initial dose of apatinib is 500mg po qd. Adjust the dose to 750mg po qd or maintain the original dose according to the patient's medication response for about 2 weeks. If there is grade III or above, or grade II and above non-hematologic toxicity, allow the dose to be lowered 2 times.
15882303|NCT03786874|Other|Identify work interruptions|estimate baseline characteristics of the collaborative working model (proportion expressed as a percentage)
15882236|NCT03787251|Drug|The chemotherapeutic drug chosen by the investigator.|"The choice of chemotherapy regimen is based on the medication habits of the drug delivery doctor and the specific circumstances of the patient.
~In addition, the following regimens may be selected as monotherapy or combination: docetaxel 60-75 mg/m2d1 q3w; irinotecan 150-180 mg/m2 d1 q2w until disease progression or patient death. If grade 3 and above or non-hematologic toxicity of grade II and above adverse event appeared, allowing the dose to be lowered twice."
15882237|NCT03787238|Device|non-invasive vagus nerve stimulation|non-invasive vagus nerve stimulation using the gammaCore Sapphire device
15882238|NCT03787225|Drug|NNC0174-0833|Participants will receive dose levels of 0.3, 0.9 or 1.8 mg of NNC0174-0833 subcutaneously. Each participant will receive only one dose.
15882239|NCT03787225|Drug|Placebo (NNC0174-0833)|Participants will receive NNC0174-0833 matched placebo subcutaneously.
15882240|NCT03787212|Device|MiBo ThermoFlo|Test Device
15882241|NCT03787212|Device|Bruder Mask|Control Device
15882242|NCT03787199|Device|Andago|The Andago is a body-weight supporting device with which a patient can walk overground
15882243|NCT03787199|Other|Treadmill|Bodyweight supported treadmill walking
15882244|NCT03787186|Drug|GLPG1690 film-coated tablets|a single oral dose of GLPG1690
15882245|NCT03787186|Drug|[14C]-GLPG1690 solution for infusion|a 15-minute IV infusion [14C]-GLPG1690
15882246|NCT03787186|Drug|[14C]-GLPG1690 capsules|single oral dose of [14C]-GLPG1690
15882247|NCT03787173|Device|Optimized|Inspiratory trigger and Expiratory trigger settings optimized by investigator
15882248|NCT03787173|Device|Automated|Inspiratory trigger and Expiratory trigger settings automatized
15882249|NCT03787160|Diagnostic Test|initial VOC|Difference in VOC profile between patients with CDH and healthy controls (2 samples per patient will be obtained after obtaining informed consent).
15882250|NCT03787160|Diagnostic Test|initial fecal microbiome|Difference of alpha and beta diversity and relative fecal bacterial abundance between patients with CDH and healthy controls (1 stool sample will be taken per patient after obtaining informed consent)
15882251|NCT03787160|Diagnostic Test|initial pulmonary microbiome|Difference of alpha and beta diversity and relative pulmonary bacterial abundance between patients with CDH and healthy controls (1 deep induced sputum sample will be taken per patient after obtaining informed consent)
15882252|NCT03787160|Diagnostic Test|Maximum oxygen uptake|Comparison of the maximum oxygen uptake (corrected for body weight and gender) as determined by bicycle spiroergometry between patients with CDH and healthy controls
15882253|NCT03787160|Diagnostic Test|Functional residual capacity|FRC will be determined by spirometry, bodyplethysmography and N2-breath wash out method. FRC will be compared between patients after CDH and healthy controls.
15882254|NCT03787160|Dietary Supplement|Probiotic treatment|CDH patients will receive OmniBiotic 6(R) (Allergosan, Graz, Austria) probiotic supplementation 1 sachet daily for 3 months.
15882255|NCT03787160|Diagnostic Test|VOC probiotic|Determination of the VOC profile 3 months after discontinuing probiotic treatment. Comparison to the profiles before the treatment.
15882256|NCT03787160|Diagnostic Test|Fecal microbiome probiotic|Determination of the fecal microbiome from 1 sample per patient (alpha and beta diversity, relative bacterial abundance at the genus level) 3 months after discontinuing probiotic treatment. Comparison to the profiles before the treatment.
15882257|NCT03787160|Diagnostic Test|Pulmonary microbiome probiotic|Determination of the fecal microbiome from 1 deep induced sputum sample per patient (alpha and beta diversity, relative bacterial abundance at the genus level) 3 months after discontinuing probiotic treatment. Comparison to the profiles before the treatment.
15882258|NCT03787147|Device|Google Cardboard|Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI). VRA is a the oculus or the google cardboard that helps decrease anxiety. The participant in the oculus or the Google cardboard arms are asked to watch VR videos during the spinal injection.
15882259|NCT03787147|Device|Oculus|Assessing the Efficacy of Virtual Reality Analgesia (VRA) in Adult Patients for Pain Control During Spinal Injections (SI). VRA is a the oculus or the google cardboard that helps decrease anxiety. The participant in the oculus or the Google cardboard arms are asked to watch VR videos during the spinal injection.
15882260|NCT03787147|Drug|Lidocaine Hydrochloride|All groups will receive pharmaceutical analgesia, either lidocaine or bupivacaine, depending on the condition. Dosage and frequency of pharmaceutical analgesia will be tailored to each participant's condition.
15882261|NCT03787147|Drug|Bupivacaine|All groups will receive pharmaceutical analgesia, either lidocaine or bupivacaine, depending on the condition. Dosage and frequency of pharmaceutical analgesia will be tailored to each participant's condition.
15882262|NCT03787134|Behavioral|working memory and attention|Behavioral tests of working memory and attention
15882263|NCT03787121|Procedure|care management pathways|different care management pathways, including thyroidectomy, iode 131, hormonal treatment and type of follow up
15882264|NCT03787108|Other|Magnetic resonance spectroscopy measurement|Magnetic resonance spectroscopy measurement will be performed to measure liver fat content.
15882265|NCT03787095|Biological|Cemiplimab|Administered as an intravenous (IV) infusion
15882266|NCT03787095|Biological|Placebo|Admixture of Diluent for REGN2810 and sodium chloride for injection, administered as an IV infusion
15882267|NCT03787082|Drug|Nitrates|1,000 mg/11.18 mmol, oral
15882268|NCT03787082|Drug|Chlorhexidine Gluconate Mouthwash|chlorhexidine gluconate 0.12% (15mL) mouth rinse for 1 minute
15882269|NCT03787082|Drug|Placebo Mouthwash|sterile water (15mL) mouth rinse for 1 minute
15882270|NCT03787069|Drug|iv Lignocaine vs placebo|Lignocaine is available in an ampule of 10 ml containing 20 mg/ml of lignocaine or 2%, Lignocaine will be given in dose of 1.5 mg/kg I/V
15882304|NCT03786874|Other|Understand work interruptions|Team-review of the results of the task interruption and professional representations, identify activities to protect from task interruption
15882305|NCT03786874|Other|Act to limited work interruptions|Adaptation of organizations; Awareness raising and Coaching for change
15882376|NCT03786289|Biological|Recombinant erythropoietin injection (CHO cells)|Recombinant erythropoietin injection (CHO cells) 10000IU single subcutaneous injection at Day1
15882377|NCT03786276|Behavioral|VR-WMR-Only|Participants will spend up to 30 minutes in a VR-WMR environment during each training session.
15882271|NCT03787056|Other|Blood draws|"Blood draws are realized at each steps of patient disease management. The volume of each blood drawn is 25 mL for progastrin measurements and 5 mL for the dosage of the other tumor markers. The frequency depend to the cancer and treatment administered :
~Baseline at diagnosis : Local radical treatment : within 24h before surgery, within 24h after surgery and at the post-surgery follow up visit
~Chemotherapy treatment : every 3 or 4 weeks
~Radiotherapy : start day and at the end of radiation (end of treatment visit)
~Palliative systemic treatment (only palliative cohorts) : every 3 to 12 weeks. Follow until the third progression or change of treatment line, or alternatively up to 5 years after inclusion
~In case of PD or TOX
~Follow up: at each visit scheduled (every 3 months) for the first 2 years, then every 6 months for 3 years
~Relapse : withdrawn from the study and last progastrin measurement. Patient could be enrolled in the non-curative intent cohort"
15882272|NCT03787043|Drug|FDC(MP-513 10mg/Metformin XR 750mg)|
15882273|NCT03787030|Drug|Vitamin E Acetate ointment|Application of 1 ml of ointment to the distal anal canal, every 12 hours for an 8-week period.
15882274|NCT03787030|Drug|Glyceryl trinitrate ointment|Application of 375 mg of ointment to the distal anal canal, every 12 hours for an 8-week period.
15882275|NCT03787017|Drug|FDC(MP-513 20mg/Metformin XR 1000mg)|
15882276|NCT03787017|Drug|MP-513 20mg|
15882277|NCT03787017|Drug|Metformin XR 1000mg|
15882278|NCT03787004|Drug|CNTX-6970|Oral dose CNTX-6970
15882279|NCT03787004|Other|Placebo|Oral dose placebo
15882281|NCT03786978|Behavioral|Structured pharmaceutical care|Patients receive a structured pharmaceutical care from one year after basal hospital discharge
15882282|NCT03786978|Behavioral|Comparator|Patient received a single phone call 30 days after basal hospital discharge.
15882283|NCT03786965|Other|On-pump CABG|On-pump CABG
15882284|NCT03786965|Other|Off-pump CABG|Off-pump CABG
15882285|NCT03786965|Other|Pump-assisted CABG|Pump-assisted CABG
15882286|NCT03786965|Other|Valve Repair Procedure without CABG.|Valve Repair Procedure without CABG (open heart procedure).
15882287|NCT03786965|Other|Valve Repair Procedure with CABG.|Valve Repair Procedure with CABG (open heart procedure).
15882288|NCT03786952|Behavioral|Stress immediately before learning in males|Male participants will be exposed to the socially evaluated cold pressor test immediately prior to fear learning. Participants will place their dominant hand in a bath of ice cold water for up to 3 minutes. The participants will also be informed that they are being videotaped for analysis of facial expressions and be asked to stare at a camera throughout the manipulation. Immediately following the acute stressor, participants will undergo the acquisition phase of fear conditioning.
15882289|NCT03786952|Behavioral|Sham control immediately before learning in males|Male participants will be exposed to the sham control condition (no stress) immediately prior to fear learning. Participants will place their dominant hand in a bath of lukewarm water for up to 3 minutes. Immediately following the sham control condition, participants will undergo the acquisition phase of fear conditioning.
15882290|NCT03786952|Behavioral|Stress 30 minutes before learning in males|Male participants will be exposed to the socially evaluated cold pressor test 30 minutes prior to fear learning. Participants will place their dominant hand in a bath of ice cold water for up to 3 minutes. The participants will also be informed that they are being videotaped for analysis of facial expressions and be asked to stare at a camera throughout the manipulation. Thirty minutes following the acute stressor, participants will undergo the acquisition phase of fear conditioning.
15882291|NCT03786952|Behavioral|Sham control 30 minutes before learning in males|Male participants will be exposed to the sham control condition (no stress) 30 minutes prior to fear learning. Participants will place their dominant hand in a bath of lukewarm water for up to 3 minutes. Thirty minutes following the sham control condition, participants will undergo the acquisition phase of fear conditioning.
15882292|NCT03786952|Behavioral|Stress immediately before learning in females|Female participants will be exposed to the socially evaluated cold pressor test immediately prior to fear learning. Participants will place their dominant hand in a bath of ice cold water for up to 3 minutes. The participants will also be informed that they are being videotaped for analysis of facial expressions and be asked to stare at a camera throughout the manipulation. Immediately following the acute stressor, participants will undergo the acquisition phase of fear conditioning.
15882293|NCT03786952|Behavioral|Sham control immediately before learning in females|Female participants will be exposed to the sham control condition (no stress) immediately prior to fear learning. Participants will place their dominant hand in a bath of lukewarm water for up to 3 minutes. Immediately following the sham control condition, participants will undergo the acquisition phase of fear conditioning.
15882294|NCT03786952|Behavioral|Stress 30 minutes before learning in females|Female participants will be exposed to the socially evaluated cold pressor test 30 minutes prior to fear learning. Participants will place their dominant hand in a bath of ice cold water for up to 3 minutes. The participants will also be informed that they are being videotaped for analysis of facial expressions and be asked to stare at a camera throughout the manipulation. Thirty minutes following the acute stressor, participants will undergo the acquisition phase of fear conditioning.
15882295|NCT03786952|Behavioral|Sham control 30 minutes before learning in females|Female participants will be exposed to the sham control condition (no stress) 30 minutes prior to fear learning. Participants will place their dominant hand in a bath of lukewarm water for up to 3 minutes. Thirty minutes following the sham control condition, participants will undergo the acquisition phase of fear conditioning.
15882296|NCT03786939|Procedure|On-pump CABG.|On-pump coronary artery bypass grafting.
15882297|NCT03786939|Procedure|Off-pump CABG.|Off-pump coronary artery bypass grafting.
15882298|NCT03786939|Procedure|Pump-assisted CABG.|Pump-assisted CABG.
15882299|NCT03786926|Drug|HMPL-689|HMPL-689 is a PI3Kδ inhibitor
15882300|NCT03786913|Diagnostic Test|Quantitative muscle ultrasound measurements|Quantitative ultrasound measurements will be performed to biceps, forearm flexors, quadriceps and tibialis anterior according to a standard protocol; for each muscle three consecutive measurements will be made to minimize variation in echo intensity during analysis .The captured images will be analyzed offline for echo intensity by means of computer-assisted grayscale histogram analysis.
15882301|NCT03786900|Biological|Fecal Microbiota Transplantation (FMT) product PRIM-DJ2727|
15882302|NCT03786887|Drug|Nalbuphine|dosage of nalbuphine
15882306|NCT03786861|Procedure|corneal WFG group|TransPRK using ESIRIS flying spot excimer laser system (SCHWIND AMARIS®500E, SCHWIND eye-tech-solutions, Kleinhostheim, Germany), with 500 Hz repetition rate for faster treatments and scanning spots and with smart pulse technology. Eye-tracking during laser ablation was achieved using a 1050 Hz infrared eye tracker centered on the pupil. Static cyclotorsion control (SCC) compensation was obtained for all patients in corneal WFG group.
15882307|NCT03786861|Procedure|aberration free group|TransPRK was performed to eligible myopic patients with or without astigmatism with corneal HOAs ≥ 0.35 µ utilizing aberration free patterns provided by ORKCAM software (SCHWIND eye-tech-solutions, Kleinostheim, Germany)
15882308|NCT03786848|Other|MiniPDX Group|Mini patient derived xenograft (MiniPDX) is a drug sensitivity test model established by transplanting primary human tumor cells into immunodeficient mice by special methods. This test can provide sensitivities of single drug or drug combination within 7 days to screen out the optimal individualized regimens for each patient.
15882309|NCT03786835|Other|Protein supplementation and regular physical activity|To determine if high protein diet and/or regular physical activity improves muscle and bone health
15882310|NCT03786822|Procedure|Cryoballoon Pulmonary Vein Isolation - PVI|A 28-mm cryoballoon (Arctic Front Advance™ Cardiac CryoAblation Catheter, Medtronic, Minneapolis, MN) will be employed. The cryoballoon catheter will be introduced into the left atrium, following a single transeptal puncture, through a 12 French steerable sheath (FlexCath, Medtronic), constantly flushed with heparinized saline. A circular mapping catheter (Achieve, Medtronic) will be advanced through the cryoballoon to the PV orifice and positioned as proximally as possible inside the vessel to record the PV potentials at baseline and monitor the isolation procedure in real time.
15882311|NCT03786809|Drug|Cimifuga Racemosa|Experimental group will use 160mg of Cimifuga Racemosa for 28 days
15882312|NCT03786809|Drug|Placebo|patients of the placebo group will use placebo once a day for 28 days
15882313|NCT03786796|Drug|Olaparib|Olaparib is a crystalline solid, is non-chiral and shows pH-independent solubility of approximately 0.1 mg/mL across the physiological range. Olaparib is presented for oral administration as a green, film-coated tablet containing 25 mg, 100 mg or 150 mg of drug substance. The 100 mg strength is also available as a yellow, film-coated tablet. The 25 mg, 100 mg and 150 mg strengths of olaparib tablets are composed of the same constituents. The tablet cores comprise: olaparib, copovidone, colloidal silicon dioxide, mannitol and sodium stearyl fumarate. The composition of the green tablet film coating is: hydroxypropyl methylcellulose (hypromellose), macrogol 400 (polyethylene glycol 400), titanium dioxide, iron oxide yellow and iron oxide black. The yellow tablet film coating only differs from the green film coating with the omission of iron oxide black.
15882314|NCT03786783|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo ASCT
15882315|NCT03786783|Drug|Carboplatin|Given IV
15882316|NCT03786783|Drug|Cisplatin|Given IV
15882317|NCT03786783|Drug|Cyclophosphamide|Given IV
15882318|NCT03786783|Drug|Dexrazoxane|Given IV
15882319|NCT03786783|Biological|Dinutuximab|Given IV
15882320|NCT03786783|Drug|Doxorubicin|Given IV
15882321|NCT03786783|Drug|Etoposide|Given IV
15882322|NCT03786783|Radiation|External Beam Radiation Therapy|Undergo EBRT
15882323|NCT03786783|Drug|Isotretinoin|Given PO
15882324|NCT03786783|Drug|Melphalan|Given IV
15882325|NCT03786783|Biological|Sargramostim|Given SC
15882326|NCT03786783|Drug|Thiotepa|Given IV
15882327|NCT03786783|Drug|Topotecan|Given IV
15882328|NCT03786783|Drug|Vincristine|Given IV
15882329|NCT03786770|Biological|DaxibotulinumtoxinA for injection|Intramuscular injection
15882330|NCT03786757|Drug|Rivaroxaban|Rivaroxaban 2.5mg/BID will be applied for 24 weeks unless severe safety outcome occurs. All patients in both group will take aspirin 100mg/QD, clopidogrel 75mg/QD and proton pump inhibitor during the intervention.
15882331|NCT03786744|Biological|ASD CB-MNC injection.|CB-MNC injection from different donors. One dose consist 20-50 mil MNC/kg.The protocol include 3 injection at monthly intervals.
15882332|NCT03786744|Other|Standard therapy.|The standard therapy can include drugs, special psychology training etc.
15882333|NCT03786731|Behavioral|Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)|TranS-C integrates elements of evidence-based interventions, namely cognitive-behavioural therapy for insomnia, delayed sleep phase type, and interpersonal and social rhythm therapy.
15882334|NCT03786718|Other|Patient-facing Diabetes Dashboard|The Patient-facing Diabetes Dashboard is embedded within a patient web portal and includes graphics to visualize and summarize patients' health data, incorporates motivational strategies (e.g., social comparisons and gamification), provides literacy level appropriate educational resources, and contains secure-messaging capability.
15882335|NCT03786705|Other|Massive transfusion|Trauma patients who had received blood transfusion≥10 U
15882336|NCT03786705|Other|Non-Massive Transfusion|Trauma patients who had received blood transfusion<10 U
15882337|NCT03786692|Drug|Arm A|Carboplatin + Pemetrexed + Bevacizumab + Atezolizumab
15882338|NCT03786692|Drug|Arm B|Carboplatin + Pemetrexed + Bevacizumab
15882339|NCT03786679|Device|Ultrasling ER III orthosis|Application of orthosis and start of rehabilitation after four weeks.
15882340|NCT03786666|Procedure|Carotid artery recanalization CEA or carotid artery stenting|Carotid artery recanalization CEA or carotid artery stenting
15882342|NCT03786627|Other|Combined NMES and motor control|This group will receive the neuromuscular electrical stimulation using interferential mode (6000 Hz, beat frequency 20-50 Hz, scanning effect) on bilateral lumbar multifidus muscles. The intensity will be set at the subject's maximum tolerance. Stimulation will be set at 10 seconds on and 60 seconds off to minimize muscle fatigue. The total stimulation time is 15 minutes. After that, this group will receive 30 minutes motor control training. This motor control training will focus on the control of the lumbar multifidus muscle in various functional tasks. It is believed to restore the motor units in individuals with arthrogenic muscle inhibition. This motor control training will take approximately 30 minutes. This group will receive intervention twice a week for 8 weeks.
15882378|NCT03786276|Behavioral|Exercise-only|Participants will ride a stationary recumbent bicycle for up to 30 minutes during each training session.
15882343|NCT03786627|Other|Motor control and placebo NMES|This group will the neuromuscular electrical stimulation without turning the electrical current for 15 minutes. After that, this group will receive 30 minutes motor control training. This motor control training will focus on the control of the lumbar multifidus muscle in various functional tasks. This motor control training will take approximately 30 minutes. This group will receive intervention twice a week for 8 weeks.
15882344|NCT03786614|Other|Discontinuation of serotonergic antidepressants|Discontinuation of serotonergic antidepressants and possibly shift to other antidepressant categories that were proven to be effective in treating depression such as pramipexole, bupropion, quetiapine, lurasidone, brexpipazole. Additionally, subjects will have access to other treatment measures of treating treatment resistant depression.
15882345|NCT03786614|Other|Continuation of serotonergic medications|Continuation of serotonergic medications which is the standard care of treatment. Additionally, subjects will have access to other treatment measures of treating treatment resistant depression.
15882346|NCT03786601|Other|Observation|The participants were assigned to different groups according to the results of HPV detection.
15882347|NCT03786588|Other|Observation|The patients with the negative results of HPV infection, and assigned to different group according to the CPP manifestation.
15882348|NCT03786575|Diagnostic Test|Next Generation Sequencing (NGS) detection|The NGS detection panel is designed by our team and covers genes that are clinically useful and have definite guiding significance for endocrine therapy
15882349|NCT03786562|Drug|Intrathecal Morphine|Group 1
15882350|NCT03786562|Drug|Intrathecal Morphine + Intravenous Nalbuphine|Group 2
15882351|NCT03786549|Other|pediatric-adult care transition program|"Three structured axes of multidisciplinary interventions are added to the usual follow-up for the patients drawn in this interventional arm. Those axes integrate the bioclinical medical care and include the parents of the adolescent
~Three axes are :
~Educative, family (patient and parent), at home
~Psychological, with the patient individually
~Medico-social orientation, group of patients"
15882352|NCT03786536|Device|MediSieve Magnetic Haemofiltration System|The MediSieve Magnetic Haemofiltration System is a medical device intended for use in extracorporeal clinical procedures to remove magnetic targets (e.g. malaria infected red blood cells) from a patient's bloodstream.
15882353|NCT03786523|Behavioral|Time restricted feeding|Participants will receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women during a window of 8 h/d (8 am to 4 pm).
15882354|NCT03786523|Behavioral|Continuous Energy Restriction|Participants will follow receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women, without restriction on feeding time.
15882355|NCT03786510|Behavioral|Active control|Control group received a personalized advice on lifestyle modification to prevent dementia and usual care of Community Center for Dementia.
15882356|NCT03786510|Behavioral|Intensive + Maintenance program|"Both intensive and maintenance program
~Intensive program The 4-week group-based intensive program was comprised of eight sessions; each session consisted of (1) a 30-min review of the tasks, (2) a 50-min training period, and (3) a 10-min meeting to assign tasks on an individual basis. A study nurse-guided training for modification of vascular risk factors, diet, cognitive and social activity were conducted, And, a physiotherapist conducted an exercise training mainly composed of muscle strengthening and stretching.
~Maintenance program The allocated study assistants monthly check-up whether participants adhere to the altered habits or not, based on the workbook"
15882357|NCT03786510|Behavioral|Intensive program only|"Only the intensive program was conducted.
~The 4-week group-based intensive program was comprised of eight sessions; each session consisted of (1) a 30-min review of the tasks, (2) a 50-min training period, and (3) a 10-min meeting to assign tasks on an individual basis. A study nurse-guided training for modification of vascular risk factors, diet, cognitive and social activity were conducted, And, a physiotherapist conducted an exercise training mainly composed of muscle strengthening and stretching."
15882358|NCT03786484|Drug|PBF-999|Phosphodiesterase 10 inhibitor (PDE10i)
15882359|NCT03786471|Other|Health System-based Dementia Care|Active comparator
15882360|NCT03786471|Other|Community-based Dementia Care|Active comparator
15882361|NCT03786471|Other|Enhanced Usual Care|Control
15882362|NCT03786458|Behavioral|web-based decision aid|The decision aid is then developed further process of evidence synthesis and multidisciplinary external review.
15882363|NCT03786432|Device|Spira-C Interbody Device|40 subjects undergoing anterior cervical discectomy and fusion surgery using Spira-C titanium interbody device
15882364|NCT03786419|Drug|Atezolizumab|Participants will be given 1200 mg of Atezolizumab as single agent by IV infusion every 21 days. First infusion will be over 60 min. Subsequent Atezolizumab cycles may be administered for 30 minutes, if there were no perfusion-related toxicity
15882365|NCT03786406|Other|No treatment given|No specific intervention is studied. All anti-diabetic and CV medication will be prescribed at the physician's discretion under routine clinical practice conditions.
15882366|NCT03786393|Diagnostic Test|ACR 1990 fibromyalgia critters|ACR 1990 fibromyalgia critters
15882367|NCT03786380|Drug|Relamorelin 10 μg|Relamorelin 10 μg injected subcutaneously twice daily.
15882368|NCT03786354|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo 3DCRT
15882369|NCT03786354|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
15882370|NCT03786341|Device|with auxiliary illuminator|Ambulation training with laser quad-cane for 15 minutes and typical physical therapy with strengthening and balance training for 15 minutes.
15882371|NCT03786328|Behavioral|Standard Psychiatric Treatment|Standard psychiatric treatment is offered individuals identified with a clinical mental disorder. Treatment will follow golden standard treatment in the psychiatric clinic, meaning a combination of therapy and psychopharmacological treatment.
15882372|NCT03786328|Behavioral|Preventive Psychological Treatment|Preventive Psychological Treatment is offered individuals identified with a sub-clinical mental condition. Treatment consists of 8 sessions of cognitive-behavioural therapy.
15882373|NCT03786302|Drug|TAMP bioglass|TAMP bioglass compared to Biodentine in the regeneration on pulpotomized primary teeth
15882374|NCT03786302|Drug|Biodentine|TAMP bioglass compared to Biodentine in the regeneration on pulpotomized primary teeth
15882375|NCT03786289|Biological|Recombinant human serum albumin/erythropoietin fusion protein|Recombinant human serum protein/erythropoietin fusion protein 150μg-1200μg single subcutaneous injection at Day1
15882379|NCT03786276|Behavioral|Active VR-WMR|Participants will spend up to 30 minutes in a VR-WMR environment while riding a stationary, recumbent bicycle during each training session.
15882380|NCT03786250|Procedure|Geriatric Assessment|Systematic screening of delirium, prevention of delirium, early treatment, pain management with scales adapted to chronicity, conciliation of medication to emergency discharge, among others.
15882381|NCT03786237|Drug|Rigosertib Oral Capsules / Rigosertib Intravenous|"Patients will take Rigosertib either as oral capsules or will get intravenous infusions depending on the needs of the patients.
~Oral Capsules:
~Patients will take oral Rigosertib continuously for a total of three weeks, every four week cycle (three weeks on, one week off drug) for up to 13 cycles. Patients will take 560 mg of oral Rigosertib (ie, 2 capsules of 280 mg) in the morning and in the afternoon, total of 1120mg/day.
~Intravenous Infusions:
~For IV treatment Rigosertib 1800 mg/24 hr is diluted in 0.9% sodium chloride for injection just prior to dosing and is administered as a 72-hr CIV infusion on days 1, 2, and 3 of a 2-week cycle for the first eight 2-week cycles, then on days 1, 2, and 3 of a 4-week cycle thereafter."
15882382|NCT03786224|Behavioral|Contingency Management|Six months of cannabis abstinence will be incentivized using a standard contingency management approach involving an escalating schedule of payment for abstinence and attendance.
15882383|NCT03786211|Procedure|IANB by the guide of Panoramic|IANB will be injected by the guide of panoramic radiograph
15882384|NCT03786211|Procedure|IANB without the guide of Panoramic|IANB will be injected without the guide of panoramic radiograph, in the routine way.
15882385|NCT03786198|Behavioral|Activity program|Home-based walking intervention, wearing a wrist worn activity tracker, for 24 weeks
15882386|NCT03786198|Behavioral|Control|Physical activity according to standard recommendations, wearing a wrist worn activity tracker (with no feedback about performed activity), for 24 weeks + standard adjuvant AI therapy
15882387|NCT03786185|Behavioral|MusicPlast|"Each subject will receive 20 sessions of the computerized training based on a simplified music reading protocol. The training will be provided via a smartphone or a tablet. Each training session will last for 20 minutes and the log file will be directly available to the researcher, allowing him/her to follow subject's timely participation. The stimuli used in the training protocol will consist of a visual image showing a circle on top of a background of 5 horizontal lines. The auditory part of the stimulus will consist of piano melodies of known songs. The position of the circle within the five lines will either follow the rule the higher the pitch of the tone, the higher the position of the circle or it will violate the above rule. The task requires audiovisual integration."
15882388|NCT03786185|Behavioral|MusicPlast Control|Each subject will receive 20 sessions of the computerized training within a period of 4 weeks, aiming to train visual search via spot-the-difference tasks and identification of dissonance in music. Auditory and visual stimuli are concurrently presented, but do not require audiovisual integration.
15882389|NCT03786172|Behavioral|Smoking cessation Intervention|"A 10 to 15 minute standardised counseling session performed peri-operatively by an ENT resident, and based on the 5 As motivational interviewing model (Ask, Advise, Assess, Assist, Arrange)
~A motivational gadget distributed to the patients
~Nicotine replacement therapy (NRT), consisting of nicotine transdermal patches for 8 weeks, offered to the patients"
15882390|NCT03786172|Behavioral|Usual care|A 10-second brief advice to quit smoking, performed peri-operatively by an ENT resident
15882391|NCT03786159|Other|No intervention|No intervention
15882392|NCT03786133|Diagnostic Test|Analysis of microbiological tests|Collection and comparison of microbiological data
15882393|NCT03786120|Drug|Zolpidem|PO sleep aid in various doses
15882394|NCT03786107|Diagnostic Test|Almac HER-Seq Assay|whole blood sample analysis
15882395|NCT03786094|Drug|Eribulin|Eribulin alone
15882396|NCT03786094|Drug|Balixafortide|balixafortide + eribulin
15882397|NCT03786081|Drug|Tisotumab Vedotin|i.v.
15882398|NCT03786081|Drug|Bevacizumab|i.v.
15882399|NCT03786081|Drug|Pembrolizumab|i.v.
15882400|NCT03786081|Drug|Carboplatin|i.v.
15882401|NCT03786055|Behavioral|Somatic Yoga and Meditation (SYM)|A Hanna somatics and somatic yoga and meditation (SYM) protocol was designed to address sensory-motor amnesia and reduce trauma which creates reflex patterns that lead to chronic muscular contractions. The movements use voluntary muscular contraction and slow controlled eccentric contraction, with the constant focus on sensation to increase the resting length of muscles. Movements are performed slowly and gently with the least possible effort and are never forced. The protocol is endorsed by the US Army Surgeon General as treatment for chronic pain. The meditations are trauma informed and evidence based supporting pain modulation, healing and well-being.
15882402|NCT03786042|Behavioral|E-cigarette ad exposure|Participants view a series of e-cigarette TV commercials
15882403|NCT03786042|Other|non e-cigarette TV commercials|Participants view a series of non e-cigarette TV commercials
15882404|NCT03786029|Drug|Acetaminophen|"Patients will receive 320mg (10ml) Acetaminophen (Strawberry flavour), wait for 30 minutes after the administration, then they will be given the local anesthesia injection. Then the child will be asked to point to the face that fits the degree of pain on the self-reporting pain scale WBFS immediately after the injection.
~The tooth will be extracted 10 minutes after the injection, then the child will be asked to record the degree of pain on the same scale immediately after the extraction.
~Pain will be re-evaluated 15 minutes after the extraction.
~The scale will be given to the parents in order to evaluate the post-extraction pain in 1 to 6 hours while the child is at home.
~Parents' satisfaction will be evaluated using Likert fifth scale."
15882405|NCT03786029|Drug|Placebo|"Patients will receive 10ml Strawberry Juice (placebo), wait for 30 minutes after the administration, then they will be given the local anesthesia injection. Then the child will be asked to point to the face that fits the degree of pain on the self-reporting pain scale WBFS immediately after the injection.
~The tooth will be extracted 10 minutes after the injection, then the child will be asked to record the degree of pain on the same scale immediately after the extraction.
~Pain will be re-evaluated 15 minutes after the extraction.
~The scale will be given to the parents in order to evaluate the post-extraction pain in 1 to 6 hours while the child is at home.
~Parents' satisfaction will be evaluated using Likert fifth scale."
15882437|NCT03785834|Procedure|Punch Biopsy|The patient will undergo two 6 mm punch biopsies into the affected extremity at the most proximal portion of the redness.
15882548|NCT03785015|Other|Resume Aspirin 72 - 84 hours|Resume the standard treatment between 72 and 84 hours after endoscopic haemostasis
15882406|NCT03786029|Drug|Ibuprofen|"Patients will receive 200mg (10ml) of Ibuprofen (Strawberry flavour), wait for 30 minutes after the administration, then they will be given the local anesthesia injection. Then the child will be asked to point to the face that fits the degree of pain on the self-reporting pain scale WBFS immediately after the injection.
~The tooth will be extracted 10 minutes after the injection, then the child will be asked to record the degree of pain on the same scale immediately after the extraction.
~Pain will be re-evaluated 15 minutes after the extraction.
~The scale will be given to the parents in order to evaluate the post-extraction pain in 1 to 6 hours while the child is at home.
~Parents' satisfaction will be evaluated using Likert fifth scale."
15882407|NCT03786016|Behavioral|8-Days in an Isolation, Confinement Unit|"Subjects will spend 8 days/7 nights continuously in an isolated and confined unit with up to 3 other subjects. Subjects will participate in daily, timed activities such as space-relevant computer simulations, team tasks, and cognitive performance testing. Subjects will also experience altered environmental conditions (such as changes in lighting, sound and ambient temperature) while in the isolation unit. Subjects will receive orders from mission control who will monitor activity in the isolation unit and direct subjects throughout the 8-day study."
15882408|NCT03786003|Procedure|VATS|Standard video assisted thoracic surgery, no use of rib-spreader.
15882409|NCT03786003|Procedure|Thoracotomy|Standard thoracotomy
15882410|NCT03785990|Other|adipose tissue|taking a sample of the adipose tissue during operation
15882411|NCT03785990|Other|blood|taking a blood sample when a peripheral venous catheter is inserted before operation
15882412|NCT03785990|Diagnostic Test|PEAPOD|Measurement of the total adipose tissue of the infant with PEAPOD (Air Displacement-Plethysmography, Infant Body Composition System, Cosmed, Rome, Italy)
15882413|NCT03785964|Drug|Nirogacestat oral tablet|Nirogacestat tablet
15882414|NCT03785964|Drug|Placebo Oral Tablet|Sugar pill manufactured to mimic nirogacestat 50 mg tablet
15882415|NCT03785951|Dietary Supplement|Whey Protein Isolate|"Whey protein product isolated from whole milk. 79% Protein with minimal carbohydrate and fat.
~50 grams of total supplemental protein/amino acids from whey protein powder consumed in two 25g (total protein/amino acids) nutrition shakes twice per day for 8 weeks in the form of a nutritional shake."
15882416|NCT03785951|Dietary Supplement|Wheat Protein|"Enzymatically hydrolysed wheat protein containing wheat peptides. 75% Protein with minimal carbohydrate and fat.
~50 grams of total supplemental protein/amino acids from whet protein peptide powder consumed in two 25g (total protein/amino acids) nutrition shakes twice per day for 8 weeks in the form of a nutritional shake."
15882417|NCT03785951|Dietary Supplement|Wheat Protein with Leucine|"Enzymatically hydrolysed wheat protein containing wheat peptides with and additional 1.4g of L-leucine. 75% Protein with minimal carbohydrate and fat and a L-leucine concentration equal to whey protein isolate.
~50 grams of total supplemental protein/amino acids from wheat protein peptide powder, with added leucine to equal the total content of the whey protein condition, consumed in two 25g (total protein/amino acids) nutrition shakes twice per day for 8 weeks."
15882418|NCT03785938|Dietary Supplement|Probiotic|Liquid probiotic supplied by the company Symprove
15882419|NCT03785938|Other|Placebo|Placebo made of maltdextrin. Will be similar in taste and consistency
15882422|NCT03785912|Behavioral|Internet-based self-help|Eight cognitive-behavioral, mindfulness and acceptance commitment based modules focusing on different aspects of adjustment problems after having an accident.
15882423|NCT03785899|Device|SPOCnew|"SPOC is an automated, algorithm based adjustment of the fraction of inspired oxygen in relation to arterial saturation (SPO2). The revised new algorithm is turned on."
15882424|NCT03785899|Device|8s SpO2 averaging|The arterial saturation (SPO2) will be averaged over 8s.
15882425|NCT03785899|Device|SPOCold|"SPOC is an automated, algorithm based adjustment of the fraction of inspired oxygen in relation to arterial saturation (SPO2). The former old algorithm is turned on."
15882426|NCT03785899|Device|2s SpO2 averaging|The arterial saturation (SPO2) will be averaged over 2s.
15882427|NCT03785886|Behavioral|Walking group|Subjects in this group perform exercise consisting of walking for 30 - 60 min at 40% - 60% HRR intensity 3-5 d•wk-1 for 3 months . Each training includes 5 min warm-up and 5 min cool-down, and the exercise should start after meals for 1 hour . Heart rate is monitored by sports bracelet . Subjects using β-blockers will not use heart rate to monitor exercise intensity , but RPE scores . And RPE( Borg scale) scores are ranged from 11-13.
15882428|NCT03785886|Behavioral|Chinese square dancing group|"Chinese square dances have been selected from 24 sets of square dances jointly launched in 2015 and 2017. According to the age and physical health status of the subjects, six dance pieces of are selected as the repertoires of the intervention in this study.
~Subjects in this group perform exercise consisting of Chinese square dances for 30-60 min at 40% - 60% HRR intensity 3-5 d•wk-1 for 3 months. Each training includes 5 min warm-up and 5 min cool-down , and the exercise should start after meals for 1 hour. Make the subjects step for 30 s to 1 min between each track to adjust the heart rate. Heart rate is monitored by sports bracelet. Subjects using β-blockers will not use heart rate to monitor exercise intensity, but RPE scores. And RPE( Borg scale) scores are ranged from 11-13."
15882429|NCT03785886|Behavioral|Control group|Walking group , Chinese square dancing group and control group are given the same health education brochures or health education lectures once a month . Specific contents of the brochure or lecture include : type 2 diabetes , hypertension related medical knowledge and the significance of intervention treatment ; prevention of type 2 diabetes , hypertension nutrition and exercise recommendations ; basic knowledge of scientific exercise and its matters needing attention .
15882430|NCT03785873|Drug|Nivolumab|Intravenous (IV) infusion
15882431|NCT03785873|Drug|Nanoliposomal-Irinotecan|Intravenous (IV) infusion
15882432|NCT03785873|Drug|5-Fluorouracil|Intravenous (IV) infusion
15882433|NCT03785873|Drug|Leucovorin|Intravenous (IV) infusion
15882434|NCT03785860|Other|Dietary Fiber|Dietary fiber will be given in a powder form to mix with a beverage of one's choice.
15882435|NCT03785860|Other|Placebo|Placebo will be given in a powder form to mix with a beverage of one's choice.
15882436|NCT03785847|Diagnostic Test|Ventica|Impedance pneumography measurement
15882546|NCT03785028|Behavioral|working memory and attention|working memory and attention tasks
15882438|NCT03785821|Dietary Supplement|BMSO|BMSO was extracted from Hualien No. 4 cultivate of bitter melon seed. BMSO were incorporated into capsules containing 0.5 g of oil. All persons took 3 capsules after each meal, i.e. 9 capsules (4.5 g of oil) daily, resulting in daily consumption of 2.3 g alpha-ESA in the BMSO group.
15882439|NCT03785821|Dietary Supplement|OO|Olive oil (extra virgin grade) was purchased from La Espanola (Acesur, Spain). OO were incorporated into capsules containing 0.5 g of oil, identical appearance to BMSO. All persons took 3 capsules after each meal, i.e. 9 capsules (4.5 g of oil) daily.
15882440|NCT03785808|Behavioral|Special Diet Therapy (low-carb)|Receive dietary guidelines and recipes and consume a low-carbohydrate diet
15882441|NCT03785808|Behavioral|Special Diet Therapy (low-fat)|Receive dietary guidelines and recipes and consume a low-fat diet
15882442|NCT03785808|Behavioral|Special Diet Therapy (USDA control)|Receive dietary guidelines and recipes and consume USDA control diet
15882443|NCT03785795|Device|Uncertain diagnosis of true labor|Multichannel EMG of uterine bioelectrical signals will be recorded using area sensors. The output of the synchronization calculations will be correlated with the time to delivery
15882444|NCT03785782|Device|Ultrasound|Breast ultrasound
15882445|NCT03785769|Procedure|HVGIC restoration with pre-etching|Pre-etching of the surface with polyacrylic acid for 10 s, followed by washing and drying the cavity with cotton balls; and fill with HVGIC, inserted into the cavity with the aid of an insertion spatula and adapted to the cavity by the digital pressure technique.
15882446|NCT03785769|Procedure|HVGIC restoration with non pre-etching|Restoration with HVGIC, inserted into the cavity with the aid of an insertion spatula and adapted to the cavity by the digital pressure technique.
15882447|NCT03785756|Drug|Ibuprofen 300 mg Oral Tablet|2 x 300 mg tablets twice in 24 hours
15882448|NCT03785756|Drug|Ibuprofen 200 mg Oral Tablet|2 x 200 mg tablets three times in 24 hours
15882449|NCT03785756|Other|Placebo of PR tablet|Up to 2 tablets four times in 24 hours
15882450|NCT03785756|Other|Placebo of IR tablet|Up to 2 tablets four times in 24 hours
15882451|NCT03785743|Procedure|TLPD Surgery|TLPD
15882452|NCT03785743|Procedure|OPD Surgery|OPD
15882453|NCT03785730|Procedure|Non-restorative cavity control - NRCC group|The proximal cavities will be enlarged with metallic sandpaper, exposing the cavity, to allow access for toothbrushing associated with 1000 ppm fluoride toothpaste.
15882454|NCT03785730|Procedure|Restoration with resin composite - RCR group|In control group, the treatment will be performed after prophylaxis and relative isolation. The selective carious tissue removal will be performed with appropriate dentin curettes. The acid conditioning will be performed only in enamel for 15 s with 37% phosphoric acid gel, and then the application of the adhesive system and restoration of resin composite will be conducted.
15882455|NCT03785717|Procedure|ROG|Bone width augmentation using bone grafting and membrane non cross linking.
15882456|NCT03785717|Procedure|ROG & ESWT|Before the bone width augmentation using bone grafting and membrane non cross linking, the patient was received ESWT (Extracorporeal shockwave therapy).
15882457|NCT03785704|Drug|Xinmailong Injection|Xinmailong injection is extracted, separated, purified and refined from Periplaneta americana. It is the second class of new drugs and the only small molecular bioactive peptide preparation approved by the State Pharmaceutical Administration (P.R.China) for the prevention and treatment of heart failure. Its main constituents include complex nucleoside bases and binding amino acids.
15882458|NCT03785691|Drug|Mirtazapine|"Mirtazapine 15 mg oral tablet (incapsulated in gelatine to provide blinding) will be administered once daily (bedtime) for 7 days. Placebo (empty gelatine capsule) will be administered once daily (morning).
~On Day 7 dosage increase is optional. If desired, mirtazapine 30 mg oral tablet (incapsulated in gelatine) will be administered once daily (bedtime) for 7 days. Placebo (empty gelatine capsule) will be administered three times daily (morning, noon and late afternoon). In case dosage increase is not desired, the subject will continue the initial treatment for an additional 7 days."
15882459|NCT03785691|Drug|Ondansetron|"Ondansetron 8 mg oral tablet (incapsulated in gelatine) will be administered twice daily (morning and bedtime) for 7 days.
~On Day 7 dosage increase is optional. If desired, ondansetron 8 mg oral tablet (incapsulated in gelatine) will be administered four times daily (morning, noon, late afternoon and bedtime) for 7 days. In case dosage increase is not desired, the subject will continue the initial treatment for an additional 7 days."
15882460|NCT03785691|Drug|Placebo|"Placebo oral tablet (empty gelatine capsule) will be administered twice daily (morning and bedtime) for 7 days.
~On Day 7 dosage increase is optional. If desired, placebo oral tablet (empty gelatine capsule) will be administered four times daily (morning, noon, late afternoon and bedtime) for 7 days. In case dosage increase is not desired, the subject will continue the initial treatment for an additional 7 days."
15882461|NCT03785678|Biological|Tenecteplase|The investigational medicinal product (IMP) for this study is tenecteplase. The recommended total dose for this study is weight-based with 0.25 mg of tenecteplase per kg, not exceeding a maximum dose of 25 mg. A single bolus dose should be administered over 5 seconds based on patient weight.
15882462|NCT03785678|Other|Placebo|Placebo is being used as the comparator since a thrombolytic is only FDA-approved in the United States for use out to 3 hours, and the standard of care guidelines support use out to 4.5 hours.
15882463|NCT03785665|Device|MDI|Capsule MD1 (Motility dummy 1)
15882464|NCT03785652|Drug|LY03005 extended-release tablets 40 mg|LY03005 extended-release tablets 40 mg group :40mg/day，orally once a day, at a regular morning time on an empty stomach or after breakfas
15882465|NCT03785652|Drug|LY03005 extended-release tablets 80 mg group|"LY03005 extended-release tablets 80 mg group :
~80mg/day，orally once a day, at a regular morning time on an empty stomach or after breakfast"
15882466|NCT03785652|Drug|LY03005 extended-release tablets 120 mg group|"LY03005 extended-release tablets 120 mg group :
~120mg/day，orally once a day, at a regular morning time on an empty stomach or after breakfast"
15882467|NCT03785652|Drug|LY03005 extended-release tablets 160 mg group|"LY03005 extended-release tablets 160 mg group :
~160mg/day，orally once a day, at a regular morning time on an empty stomach or after breakfast"
15882468|NCT03785652|Drug|Placebo group|"Placebo group :
~Placebo ，orally once a day, at a regular morning time on an empty stomach or after breakfast"
15882469|NCT03785626|Procedure|CEA surgery|patients with carotid artery severe (70-99%) stenosis or occlusion received CEA surgery
15882895|NCT03782571|Device|etafilcon A Test 2|1-DAY ACUVUE® MOIST for ASTIGMATISM
15882470|NCT03785613|Drug|Test Product T1: Buprenorphine patch (9 mg)|Buprenorphine transdermal patch formulation, containing 9 milligrams buprenorphine in an active surface area of 25 square centimeters.
15882471|NCT03785613|Drug|Test Product T2: Buprenorphine patch (3.8 mg)|Buprenorphine transdermal patch formulation, containing 3.8 milligrams buprenorphine in an active surface area of 10 square centimeters.
15882472|NCT03785613|Drug|Reference Product R: Transtec patch (20 mg)|Transtec (Registered Trademark) transdermal patch containing 20 milligrams buprenorphine in an active surface area of 25 square centimeters, release rate 35 micrograms per hour.
15882473|NCT03785613|Drug|Matching placebo patch to T1|Placebo patch to T1.
15882474|NCT03785613|Drug|Matching placebo patch to T2|Placebo patch to T2.
15882475|NCT03785613|Drug|Matching placebo patch to R|Placebo patch to R.
15882476|NCT03785600|Device|Morning Bright Light Therapy|Morning bright light: Sitting in front of a lightbox for 60 minutes every morning within 90 minutes of waking up.
15882477|NCT03785600|Device|Negative Ion Generator|Negative ion generator: Sitting in front of a modified negative ion generator for 60 min every morning within 90 minutes of waking up.
15882478|NCT03785587|Drug|Sofpironium Bromide Gel, 15%|Sofpironium Bromide Gel, 15%
15882481|NCT03785561|Other|participation in a health research study|Patients diagnosed with a musculoskeletal disorder, who are currently participating in a health research study at the outpatient osteoarthritis clinic at Frederiksberg Hospital
15882482|NCT03785548|Other|Usage of a mirror|using a mirror during the pelvic examination
15882483|NCT03785535|Device|Vibrotactile stimulation|The active treatment will involve whole-body sensory stimulation with mechanical stimuli of vibrotactile (pallesthetic) type at a relatively high rate, low intensity and long duration administered at sleep time (a total daily duration of 3 h distributed within a period of 2 h at bedtime and 1 h prior to getting up). The intensity will be 30% of power at bedtime and 45% prior to getting up.
15882484|NCT03785522|Drug|Insulin degludec|Patients will be treated with commercially available Tresiba® in a pre-filled pen injector (FlexTouch®) according to routine clinical practice at the discretion of the study doctor and in accordance with the local label. The study doctor will determine the starting dose of Tresiba® as well as any dose adjustments thereafter.
15882485|NCT03785509|Drug|DAPT, Statin|Compliance of DATP, Compliance of Statin, Drug Eluting Stent, Bare Metal Stent
15882486|NCT03785496|Drug|PDR001|PDR001 will be administered once every 3 weeks via i.v. infusions over 30 minutes, respectively. Infusions of each antibody can be extended to up to 2 hours if clinically indicated. A scheduled dose of ongoing study drugs may be delayed by up to 7 days to recover from previous AEs or a missed visit. If a scheduled dose of ongoing study drugs is delayed longer than 7 days due to an unresolved AE, the administration should be skipped and treatment resumed at the next scheduled dose. The assessment schedule will be shifted accordingly.
15882487|NCT03785483|Behavioral|Motivation|8 weeks of either action planning or mindfulness in addition to a treatment as usual which is a physical activity program of 120 minutes per week.
15882488|NCT03785470|Other|Fructose and physical inactivity|Subjects will drink 6 cans of regular sodas daily (divided throughout the day) and will decreased physical activity to less than 5000 steps daily for 10 days.
15882489|NCT03785457|Other|Repetitive Trunk Extension|Subjects will be asked to perform standing repetitive trunk extension at a rate of 10 per 45 seconds (Figure 2), repeated five times with 15-second rest breaks.
15882490|NCT03785457|Other|Sustained Trunk Extension|Subjects will be asked to perform standing sustained trunk extension for 5 x 45 seconds with 15-second rest breaks.
15882491|NCT03785444|Other|WHODAS 2.0|WHO Disability Score
15882492|NCT03785444|Other|EQ5D|Health related quality of life measured with European Quality of Life 5 Dimensions 5 Level
15882493|NCT03785444|Other|IADL|The Lawton Instrumental Activities of Daily Living
15882494|NCT03785444|Other|Barthel-Score|Barthel Score of the patient
15882495|NCT03785444|Other|SF-36|Short Form Health 36
15882496|NCT03785444|Other|MoCA Blind|Montreal Cognitive Assessment
15882497|NCT03785431|Device|PCI with Phantom Bioresorbable Scaffold|Once baseline angiography is performed and all eligibility criteria are met, the patient is included in the study. The target lesion should be crossed with a standard coronary guidewire. Next, the NIRS/IVUS and OCT probe is inserted and a pullback is being performed to evaluate the lesion and vessel morphology. The predilatation with 1:1 non-compliant or semi-compliant balloon is mandatory. Thereafter the scaffold should be inserted and position across the target lesion. Lesions up to 14 mm should be covered with the 18 mm device, for lesions of 15-20 mm a 24 mm device should be used. The scaffold will be deployed with intent to achieve the inner diameter to the reference vessel ration of 1:1 using a single inflation. Post-dilatation using a non-compliant balloon should be performed to achieve complete scaffold apposition and reduce the residual angiographic stenosis below 20%. The final NIRS/IVUS and OCT of the target vessel should be performed.
15882498|NCT03785418|Behavioral|Multicomponent Risk Factor Modification|Healthy eating, regular exercise and behavioural therapy.
15882500|NCT03785392|Procedure|Group 1 In-plane|"Group 1: Study will involve total of 15 patients with the procedure done in-plane. Before the block placement and after the block placement lung function will be measured.
~FEV1 (forced expiratory volume in 1 second ) and FVC ( forced vital Capacity ) values will be recorded. Block will be performed in plane and postprocedure lung function test will be repeated. New values of FEV1 and FVC will be obtained after the placement of the nerve block."
15882501|NCT03785392|Procedure|Group 2 out of plane|Group 2 study will adopt the out of plane technique and will involve a total of 15 patients in this group. We will do the procedure out of plane and will have lung function FEV1 and FVC measured bedside.FEV1 and FVC values will be recorded. Block will be performed out of plane and postprocedure lung function test will be measured. New values of FEV1 and FVC will be obtained
15882547|NCT03785015|Other|Resume Aspirin within 12 hours|Resume the standard treatment within 12 hours after endoscopic haemostasis
15893336|NCT03701880|Drug|Bisoprolol|Bisoprolol is beta-blocker
15882502|NCT03785379|Behavioral|Caloric restriction|A structured dietary training will be implemented to educate participants about recommended dietary habits.Patients will follow a caloric restriction (CR) diet, with an energy intake equal to the measured Resting Metabolic Rate (RMR) and with 45% carbohydrate, 20%protein, 35%fat, and 30 g/day fibers. At each follow-up, nutritionist will adjust CR to the latest measured RMR and assess the compliance to the diet.
15882503|NCT03785379|Behavioral|Exercise training|Trainers will supervise participants during 12-weeks of structured exercise consisting of 150 min/week workouts, divided in three sessions of progressive mixed (aerobic and resistance) exercise. All aerobic exercise will be performed using treadmill and/or cycle ergo-meter.
15882504|NCT03785366|Drug|VeraCept|VeraCept Intrauterine Device (IUD)
15882505|NCT03785366|Drug|ParaGard|ParaGard intrauterine copper contraceptive
15882506|NCT03785353|Behavioral|PNE lecture|A translated (from English to Spanish) lecture on Pain Neuroscience Education
15882507|NCT03785340|Drug|Brimonidine Tartrate|Brimonidine Tartrate Nanoemulsion Eye Drops 0.20% given 2 times a day for 4 weeks.
15882508|NCT03785340|Drug|Placebos|Ophthalmic buffered saline Eye Drops given 2 times a day for 4 weeks.
15882509|NCT03785327|Device|tDCS|Participants either complete active and sham tDCS sessions one week apart or an autism training program.
15882510|NCT03785327|Behavioral|Autism Training|Autism Information Presentation developed by Dr. Grace Iarocci's Autism & Developmental Disorders Lab at Simon Fraser University
15882511|NCT03785314|Other|thoracic epidural catheterization|thoracic epidural catheterization with different posture
15882512|NCT03785301|Device|Freestyle Libre Flash Glucose Monitoring|Freestyle Libre Flash Glucose Monitoring will be used in diabetic patients once a month for therr months to monitor glucose level. Patients could scan the sensor to get the glucose level at any time as they want. They could alter thier diet and exercise according to the glucose levels. Patients will be required to keep track of food and exercise during wearing FGM sensor. Physicians would adjust patients' medication according their glucose profile provided by FGM, A1c, and diet and exercise every month.
15882513|NCT03785288|Radiation|HDR vaginal brachytherapy|Arm 1: HDR vaginal brachytherapy 7 Gy in 3 fractions ; Arm 2: HDR vaginal brachytherapy 4 Gy in 6 fractions
15882514|NCT03785275|Radiation|gallium-68-exendin PET/CT|PET/CT scan after injection with gallium-68-exendin
15882517|NCT03785249|Drug|MRTX849|MRTX849 will be administered orally once or twice daily in a continuous regimen
15882518|NCT03785249|Drug|Pembrolizumab|Pembrolizumab is administered as an intravenous infusion once every 3 weeks
15882519|NCT03785249|Drug|Cetuximab|Cetuximab will be administered as an intravenous infusion once per week
15882520|NCT03785249|Drug|Afatinib|Afatinib will be administered orally once a day in a continuous regimen
15882521|NCT03785236|Radiation|68Ga-NODAGA-exendin PET/CT|68Ga-NODAGA-exendin PET/CT
15882522|NCT03785223|Drug|Methylphenidate Hydrochloride Controlled-Release Capsules|"25 mg methylphenidate hydrochloride- titrated as tolerated up to a maximum 4 capsules daily (25 mg- 100 mg total dose)
~At Week 0 or Week 7, dosing will start at 1 capsule/day for one week, and be titrated to 2 capsules/day for Week 2. 50 mg of methylphenidate hydrochloride per day (i.e. 2 capsules/day) is the minimum dose that must be achieved. The dose may be titrated to 75 mg/day for Week 3 and to 100 mg/day for Week 4 if participants are tolerating their current dose, are experiencing no adverse events, and have not fully responded. By Week 4 or Week 11, no further dose changes will occur."
15882523|NCT03785223|Drug|Placebo Capsule|At Week 0 or Week 7, dosing will start at 1 capsule/day for one week, and be titrated to 2 capsules/day for Week 2. The dose may be titrated to 75 mg/day for Week 3 and to 100 mg/day for Week 4 if participants are tolerating their current dose, are experiencing no adverse events, and have not fully responded. By Week 4 or Week 11 no further dose changes will occur.
15882524|NCT03785210|Drug|nivolumab|480 mg IV every 4 weeks
15882525|NCT03785210|Drug|tadalafil|10 mg PO daily
15882526|NCT03785210|Drug|oral vancomycin|125 mg every 6-hour (500 mg total daily dose) PO from week 1 to week 3, week 4 off.
15882527|NCT03785197|Other|Prolonged modified fasting|The prolonged modified fasting is a dietary intervention with abstinence from solid foods and a caloric intake of 100-400 kcal through juices and vegetable broths
15882528|NCT03785184|Drug|venetoclax|tablet; oral
15882529|NCT03785184|Drug|lenalidomide|capsule; oral
15882530|NCT03785184|Drug|dexamethasone|tablet; oral
15882531|NCT03785171|Procedure|surgical revascularization|Indirect revascularization procedure
15882532|NCT03785158|Other|Liquid Melatonin|Melatonin is a natural supplement.
15882533|NCT03785158|Other|Placebo|Similar looking/tasting placebo syrup
15882534|NCT03785145|Drug|MT10109L|MT10109L will be injected into the LCL.
15882535|NCT03785145|Drug|Placebo|Placebo will be injected into the LCL.
15882536|NCT03785132|Procedure|Cardiac surgery|The relationship between performance measurement of blood pressure during cardiac surgery (before, during and after cardiopulmonary bypass) and postoperative mortality
15882537|NCT03785106|Drug|Isoniazid/Rifapentine daily (4 weeks) plus pyridoxine (vitamin B6)|Isoniazid/Rifapentine daily (4 weeks) plus pyridoxine (vitamin B6)
15882538|NCT03785106|Drug|Isoniazid/Rifapentine 12-weekly plus pyridoxine (vitamin B6)|Isoniazid/Rifapentine 12-weekly plus pyridoxine (vitamin B6)
15882539|NCT03785080|Other|restart NOAC very early|withhold NOAC less than 24 hours Post OGD
15882540|NCT03785080|Other|restart NOAC early|withhold NOAC for 72 to 84 hours Post OGD
15882541|NCT03785067|Drug|telmisartan 20mg + amlodipine 2.5mg +indapamide 1.25mg|1 capsule taken orally once daily for 36 months
15882542|NCT03785067|Drug|Placebo oral capsule|1 capsule taken orally once daily for 36 months
15882543|NCT03785054|Drug|HTL0014242|HTL0014242 is a selective negative allosteric modulator (NAM) for the metabotropic glutamate (mGlu) receptor 5 subtype (mGlu5)
15882544|NCT03785054|Drug|Placebo oral capsule|Placebo treatment
15882545|NCT03785041|Drug|Levobupivacaine Hydrochloride 2.5 MG/ML|Intrarticular injection of tramadol in addition to levobupivacaine in different doses preemptive and postoperative
15882549|NCT03785002|Other|Strength training|24 strength training sessions, with approximately 1 hour duration, that will occur 2x/week
15882550|NCT03785002|Other|Protein intake|Guidance on the adequacy of protein intake (at least 20g of protein in breakfast, lunch and dinner)
15882551|NCT03784976|Other|Iyengar Yoga Therapy|2 weekly yoga class (1.25 hours each)
15882552|NCT03784963|Drug|Omega 3 fatty acids|Patients will receive 4 grams fish oil once daily
15882553|NCT03784963|Other|Placebo|Standard of care
15882554|NCT03784950|Behavioral|Rating tool|eConsult Specialty Reviewers are asked to rate the quality of other specialists' recently completed eConsult exchanges on the following four dimensions: 1) efforts to elicit additional information from PCPs, when needed; 2) medical decision making; 3) inclusion of educational content for PCPs, when appropriate; 4) perceived effect on the PCP-specialist relationship (i.e., overall tone of the eConsult exchange)
15882555|NCT03784950|Behavioral|Feedback|eConsult Specialty Reviewers receive confidential feedback via email on their performance (top performer vs not a top performer) as compared to colleagues in their specialty. Feedback is based on other reviewers ratings of their eConsult exchanges on the following four dimensions: 1) efforts to elicit additional information from PCPs, when needed; 2) medical decision making; 3) inclusion of educational content for PCPs, when appropriate; 4) perceived effect on the PCP-specialist relationship (i.e., overall tone of the eConsult exchange)
15882556|NCT03784937|Diagnostic Test|Doppler ultrasound|Each patient received Doppler ultrasound for research of DVT, no matter the risk stratification.
15882557|NCT03784924|Diagnostic Test|MRI prostate|MRI and laboratory biomarkers
15882558|NCT03784911|Device|SOZO Device|SOZO device will estimate fluid status, total body composition, metabolic report, skeletal muscle mass, phase angle, body mass index, weight, and hydration index analysis. SOZO measurements will be performed before the start of cancer treatment, at the 1/4, 1/2, and 3/4 time points of treatment, and after completion of treatment. Participants be asked to fast for at least 8 hours before each visit, but water may be consumed to ensure they are well-hydrated. Participants will be asked to provide a urine sample at each visit and to report the color of your urine to the staff so they can determine how well hydrated the participants are. If not hydrated to the extent needed, participants will be asked to drink water and repeat the urine sample again after 30 minutes.
15882559|NCT03784911|Device|DEXA Scan|DEXA scan bone density reading with hip and spine measurements as well as a whole body composition scan will be performed. Where DEXA cannot be collected on the same day as other study assessments, Weight/BMI, Urine Color, and SOZO should all be collected (or repeated if already done) to coincide with the DEXA scan if SOZO is available at DEXA location.
15882560|NCT03784898|Other|Blood draw for future biomarker analysis|Each participant was required to undergo blood draw for future genetic testing and biomarker analysis as mentioned in the informed consent form (ICF).
15882561|NCT03784885|Biological|AD07010|A protein based adjuvant
15882562|NCT03784885|Biological|Inactivated trivalent influenza vaccine|Inactivated trivalent seasonal influenza vaccine
15882563|NCT03784872|Procedure|Laparoscopic guided Ventrosuspension|Laparoscopy was done. Under vision the skin overlying the attachment of the round ligament to the anterior abdominal wall was incised followed by introduction of 30 curved needle attached to absorpable Vicryl 2/0 suture through the incision and withdrawn through grasper under laparoscopi vision. The needle was turned around the round ligament all through its length to plicate it then the needle was pushed again beside its entry side to appear at the skin incision. The same was repeated on the other side and both sutures were tied at the subcutaneous tissue simultaneously. then the laparoscopy was withdrawn followed by closure of the skin incision.
15882564|NCT03784859|Device|Insertion of Tissue Expander with Fluid Reservoir|Use of unique expander type in first stage of a two-stage breast reconstruction, without prolonged drain placement.
15882565|NCT03784846|Behavioral|Mindfulness-Based Resilience Training|MBRT is an 8-week program combining training in standardized mindfulness practices targeting factors that facilitate resilience, CBT, and psychoeducation. It contains experiential and didactic exercises including body scan, sitting and walking meditation, mindful movement and discussions.
15882566|NCT03784846|Behavioral|Stress Management Education|SME was designed as an active control condition for other Mindfulness-Based Intervention trials. SME uses a group-based didactic approach with modules on physiological and dietary effects of stress, time management, sleep physiology and insomnia, nutrition, exercise, stress hardiness, and factors mitigating impacts of stress.
15882567|NCT03784820|Behavioral|UNITE|UNITE includes three stages: early treatment (psychoeducation and understanding the couple's experience of BED within the relationship); mid-treatment (effective communication, interpersonal problem-solving, and emotion regulation skills), and late treatment (relapse prevention). Additional relevant topics may be covered including body image, weight stigma, weight and health concerns, and intimacy and sexuality issues.
15882568|NCT03784820|Behavioral|CBT-E|CBT-E includes four stages: an introductory stage (psychoeducation, normalization of eating patterns, and symptom self-monitoring); a second, brief stage (review progress and formulate plans for the subsequent treatment phase); a third stage (elimination of dieting, reducing shape checking and avoidance behaviors, educating about mood tolerance, and targeting overevaluation of shape and weight); and the fourth stage (maintaining progress and minimizing relapse risk).
15882569|NCT03784807|Diagnostic Test|synovial calprotectin, confocal laser microscopy|Calprotectin will be determined in synovial fluid of patients with septic and aseptic failure of their prosthesis. CLSM will be used to detect presence of microorganisms in synovial fluid. Susceptibility to antimicrobials of bacterial strains isolated from patients with prosthetic joint infections will be assessed using planktonic cells and biofilm associated bacteria
15882570|NCT03784794|Diagnostic Test|Thromboelastometry|devices generate output by transducing changes in the viscoelastic strength of a small sample of clotting blood (300 µl) to which a constant rotational force is applied. These point of care devices allow visual assessment of blood coagulation from clot formation, through propagation, and stabilization, until clot dissolution. Computer analysis of the output allows sophisticated clot formation/dissolution kinetics and clot strength data to be generated
15882571|NCT03784794|Diagnostic Test|Standard Coagulation Test|coagulation tests, such as the prothrombin time (PT), activated partial thromboplastin time (aPTT), and thrombin time (TT), to assess blood clotting function in patients. Clauss Fibrinogen.
15882780|NCT03783442|Drug|Fluorouracil (5-FU)|750 to 800 mg/m2 IV continuous infusion over 24 hours daily on Days 1 to 5 Q3W
15882572|NCT03784794|Drug|Fibrinogen Concentrate Human|To treat acquired fribinogen deficiency investigators will treat with the following doses FIBTEM A5 = 9-11 MM a 2 G FIBRINOGEN CONC. (25 MG/KG); FIBTEM A5 = 4-8 MM a 4 G FIBRINOGEN CONC. (50 MG/KG); FIBTEM A5 < 4 MM a 6 G FIBRINOGEN CONC. (75 MG/KG)
15882573|NCT03784794|Drug|Prothrombin Complex Concentrates|to treat acquired factor deficiency investigators will treat as follows PROTROMBIN COMPLEX CONCENTRATE EXTEM CT > 80 SEC AND FIBTEM A5 ≥ 8 MM 4F-PCC 20 IU/KG (F II, VII, IX and X) GOAL: EXTEM CT ≤ 80 SEC
15882574|NCT03784794|Other|Platelets|PLATELETS EXTEM A5 < 40 MM AND FIBTEM A5 ≥ 12 MM EXTEM A5 < 40 MM → 1 PLATELET POOL OR APHERESIS; EXTEM A5 < 30 MM → 2 PLATELET POOL OR APHERESIS GOAL: EXTEM A5: 40-50 MM or PLATELET COUNT < 100/µL PLT < 100/µL → 1 PLATELET POOL OR APHERESIS; PLT > 50/µL → 2 PLATELET POOL OR APHERESIS GOAL: PLT COUNT > 100/µL
15882575|NCT03784794|Other|Red Blood Cells|"Transfuce Red Blood Cells if Hemoglobine levels < 7 G/DL;
~1 unit of FFP for every unit of RBC Transfused GOAL: Hb > 7.5 G/DL"
15882576|NCT03784794|Other|Fresh Frozen Plasma|FRESH FROZEN PLASMA TP AND/OR TTP PATHOLOGICAL INR, 2.0-4.0 → FFP 20 ML/KG GOAL: TP AND TTP NORMAL AND INR < 2.0
15882577|NCT03784794|Other|cryoprecipitates|FIBRINOGEN (CLAUSS) < 250 MG/DL FIB 200-250 MG/DL → CRYOS, PACK OF 10 (25 MG/KG); FIB 100-200 MG/DL → CRYOS, PACK OF 20 (50 MG/KG); FIB < 100 MG/DL → CRYOS, PACK OF 30 (75 MG/KG) GOAL: FIB > 250 MG/DL
15882578|NCT03784781|Biological|Biopsy|Mucosal biopsies under general anesthesia of the segmental bronchi of the right or left lower lobe
15882579|NCT03784781|Biological|Blood collection|Blood collection (+15mL/ current care)
15882580|NCT03784781|Biological|Bronchoalveolar lavage|Bronchoalveolar lavage fluid (3mL/Kg)
15882581|NCT03784768|Other|Plantar Vibration Group|Patients in plantar vibration group will be received 45-minute conventional physiotherapy session for 5-days in a week, over 4-week. Each physiotherapy sessions will consist of range of motion exercises, strengthening exercises, exercises such as activities of daily living, mobility and transfer activities. In addition, three sessions a week will be applied to the soles of the feet for 15 minutes with a 15-100 Hz vibration device on both sides of the soles of the feet before conventional physical therapy.
15882582|NCT03784768|Other|Control Group|Patients in control group will be received 60-minute conventional physiotherapy session for 5-days in a week, over 4-week. Each physiotherapy sessions will consist of range of motion exercises, strengthening exercises, exercises such as activities of daily living, mobility and transfer activities.
15882583|NCT03784755|Radiation|Ablative Radiation Therapy|Undergo stereotactic radiotherapy and/or surgery to all sites of disease (oligometastases and primary prostate if previously untreated).
15882584|NCT03784755|Other|Standard of care|Patients continue to receive their current planned systemic therapy at the discretion of the treating physician
15882585|NCT03784742|Other|Nitrate rich beetroot juice|James White Drinks Limited beetroot juice (0.4-0.45 g nitrate/70 ml drink).
15882586|NCT03784742|Other|Placebo beetroot juice|James White Drinks Limited Placebo beetroot juice (0 nitrate/70 ml drink).
15882587|NCT03784729|Other|Acupuncture|"The acupoints of Shenshu (BL23), Dachangshu (BL25), Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be inserted. For the bilateral BL25, sterile disposable steel needles (Huatuo, Suzhou, China; 0.3 mm×75 mm) will be inserted to a depth of 50-70mm until until participates feel a sensation similar to electric shock radiating downward to the knees. For the other four acupoints (BL23, BL40, BL57 and KI3), the needles (Huatuo, Suzhou, China; 0.3 mm×40 mm) will be inserted to a depth of 15-25 mm, gently rotated three times and lifted to achieve de qi. It should be noted that the needle at KI3 will be inserted at an angle of 45°obliquely downward. There will be 18 treatment sessions with 3 times a week for continuous 6 weeks and a 30 min treatment per session."
15882588|NCT03784729|Other|Sham acupuncture|The acupoints of Shenshu (BL23), Dachangshu (BL25), Weizhong (BL40), Chengshan (BL57) and Taixi (KI3) will be inserted into a depth of 2-3mm .No manipulation of needles without deqi will be conducted. The treatment duration and frequency of sessions for participants in the SA group will be the same as in the acupuncture group.
15882589|NCT03784716|Other|Ketogenic Diet|Ketogenic diet for 28 days. Meals will be provided to all study participants for 28 days by a prepared meal delivery service. Daily caloric needs for each participant will be determined based on height, weight, gender, age, and activity level. Meals will be prepared based on compliance with the following macronutrient guidelines: 70% fat, 25% protein, and 5% carbohydrate for the ketogenic diet.
15882590|NCT03784716|Other|Standard Weight Loss Diet|Standard weight loss diet for 28 days. Meals will be provided to all study participants for 28 days by a prepared meal delivery service. Daily caloric needs for each participant will be determined based on height, weight, gender, age, and activity level. Meals will be prepared based on compliance with the following macronutrient guidelines: 30% fat, 20% protein, and 50% carbohydrate for the standard weight loss diet.
15882591|NCT03784703|Drug|Atorvastatin 40 Mg Oral Tablet|40 mg per day atorvastatin (ATROVA group, n= 80) for 6 months
15882592|NCT03784703|Drug|Rosuvastatin 10 Mg Oral Tablet|10 mg per day rosuvastatin (ROSUVA group, n= 80) for 6 months
15882593|NCT03784690|Other|Individualized intraoperative BP management|"In the treatment group, the nurse will measure resting blood pressure three times in the ward one day before surgery (after a 5-min rest while lying supine). Average measurement will be used to calculate mean arterial pressure (MAP).
~Before and after CPB patients will receive continuous infusion of norepinephrine to maintain MAP within ± 10% of patients resting MAP. If targeted MAP during CPB could not be achieved after increasing pump-flow (not more than 130%), infusion of norepinephrine will used. After CPB, the choice of vasopressors/inotropes to maintain predefined MAP will be left on attending anesthesiologists based on patient status."
15882594|NCT03784690|Other|Standard intraoperative BP management|Standard treatment strategy will be used aiming to maintain pre-bypass and post-bypass MAP at 65-75 mm Hg. MAP during CPB will be maintained at 50-60 mm Hg. If MAP of 50-60 mm Hg during CPB could not be achieved after increasing pump-flow (not more than 130%), infusion of norepinephrine will be started. No vasodilators will be used if MAP will exceed predefined range.
15882595|NCT03784677|Drug|TRPV6 Calcium Channel Inhibitor SOR-C13|Given IV
15882596|NCT03784664|Diagnostic Test|Arterial blood gas|arterial blood sample with puncture of the radial artery
15882597|NCT03784664|Diagnostic Test|Veinous blood gas|veinous blood sample using peripheral venepuncture
15882746|NCT03783650|Behavioral|Sustainability of changes|Practices will sustain their changes, illustrating the durability of these system changes even after QIC completion and without central feedback and regular meetings.
15882598|NCT03784638|Procedure|lingually-based triangle flap design|A mucoperiosteal lingually-based triangle flap will be raised, a conventional rotary handpiece will be used under irrigation for removing the third molar.Primary wound closure will be accomplished using 4-0 silk sutures. The patients will be invited after one week for removing the sutures.
15882599|NCT03784638|Other|buccally based triangular flap design|A mucoperiosteal buccally based triangular flap will be raised, a conventional rotary handpiece will be used under irrigation for removing the third molar.Primary wound closure will be accomplished using 4-0 silk sutures. The patients will be invited after one week for removing the sutures.
15882600|NCT03784625|Drug|[131I]ICF01012 (therapeutic dose level 1)|"1 diagnostic injection (D0) at a diagnostic dose of 185 MBq. This first dose permits to pre-select patients who will received a therapeutic dose according to the dosimetry results ( binding on at least a tumoral lesion, an acceptable radiation absorbed dose to major organs)
~1 therapeutic injection (D11) at a dose of 800 MBq/m²"
15882601|NCT03784625|Drug|[131I]ICF01012 (therapeutic dose level 2)|"1 diagnostic injection (D0) at a diagnostic dose of 185 MBq. This first dose permits to pre-select patients who will received a therapeutic dose according to the dosimetry results ( binding on at least a tumoral lesion, an acceptable radiation absorbed dose to major organs)
~1 therapeutic injection (D11) at a dose of 1600 MBq/m²"
15882602|NCT03784625|Drug|[131I]ICF01012 (therapeutic dose level 3)|"1 diagnostic injection (D0) at a diagnostic dose of 185 MBq. This first dose permits to pre-select patients who will received a therapeutic dose according to the dosimetry results ( binding on at least a tumoral lesion, and an acceptable radiation absorbed dose to major organs)
~1 therapeutic injection (D11) at a dose of 2700 MBq/m²"
15882603|NCT03784625|Drug|[131I]ICF01012 (therapeutic dose level 4)|"1 diagnostic injection (D0) at a diagnostic dose of 185 MBq. This first dose permits to pre-select patients who will received a therapeutic dose according to the dosimetry results ( binding on at least a tumoral lesion, and an acceptable radiation absorbed dose to major organs)
~1 therapeutic injection (D11) at a dose of 4000 MBq/m²"
15882604|NCT03784612|Behavioral|App-technology for healthy eating habits|Access to smartphone-app, including a 12 week healthy eating program. A new theme on healthy dietary habits is presented each week.
15882605|NCT03784599|Drug|Trastuzumab emtansine|Infusion
15882606|NCT03784599|Drug|Osimertinib|Tablet
15882607|NCT03784573|Behavioral|Dog + handler|Dog + handler
15882608|NCT03784573|Behavioral|No dog|No dog
15882609|NCT03784560|Other|The Psychomotor Vigilance Task (PVT)|PVT has emerged as one of the most widely used tools to assess vigilant attention. Vigilance can be defined as sustained attention and tonic alertness. In sleep deprived individuals, vigilance is the component of cognition that is most consistently and dramatically affected. The PVT is a reaction-time test that allows the collection of a large amount of data in a relatively short period of time. These characteristics increase the sensitivity of the test to detect even small changes in vigilant attention, which can wax and wane within seconds.
15882610|NCT03784560|Other|Epworth Sleepiness Scale|"Epworth Sleepiness Scale a set of questions that assess excessive daytime sleepiness during professional activities and vacations.
~This scale was designed to assess the efficiency of sleep apnea treatments. It is also used for the subjective sleepiness assessment based on the likelihood of falling asleep in different everyday life situations. This results in an overall score."
15882611|NCT03784560|Other|Karolinska sleeping scale|"The KSS is assumed to be an ordinal scale with a unitary structure. KSS scores may require standardization to control for differences between subjects. The changes observed in the EEG/EOG with drowsiness do not usually appear until KSS scores reach 7 and higher. Lower KSS scores (<5) may reflect differences in the subjective awareness of fatigue as much, or more than, levels of drowsiness.
~Higher KSS scores (7+) may refer more specifically to the state of drowsiness because the subject may then have experienced involuntary dozing behavior, with lapsing episodes and brief loss of awareness of the here-and-now, followed by arousal and the return of awareness, including some awareness of recently having dozed off"
15882612|NCT03784560|Other|Trail making test|Most variants of this test, which was apparently introduced in 1938 by Partington (Partington & Leiter, 1949), have at least two conditions. In condition A the participant is to draw lines to connect circled numbers in a numerical sequence (i.e., 1-2-3, etc.) as rapidly as possible. In condition B the participant is to draw lines to connect circled numbers and letters in an alternating numeric and alphabetic sequence (i.e., 1-A-2-B, etc.) as rapidly as possible.
15882613|NCT03784547|Drug|Ocrelizumab|already described
15882614|NCT03784534|Other|Imaging|high= density (64 sensors) EEG and anatomical MRI (T1 and tensor imaging) scan
15882615|NCT03784534|Behavioral|Clinical and behavioral testing : Motor recovery progress|NIHSS with motor subitems and Rankin and Barthel score, measure of functional independence and Hemispatial neglect, test of Ashworth
15882616|NCT03784534|Behavioral|Clinical and behavioral testing : Motor skills|the ARAT or ACTION RESEARCH ARM TEST, hand grip strength, Fugl Meyer
15882617|NCT03784521|Device|In-line filtration|In-line filtration is used during anesthesia and intensive care unit in study group to purify fluids administrations.
15882618|NCT03784521|Device|Standard care|Patients are treated with standard intravenous solutions and vascular access management
15882619|NCT03784495|Drug|Melatonin 1mg|1 mg/day 30 minutes before sleep
15882620|NCT03784495|Dietary Supplement|Essential Aminoacids (eAA)|4g/day of Essential Aminoacids during breakfast. Packets of powdered amino acid supplements (42.0% leucine, 14.0% lysine, 10.5% valine, 10.5% isoleucine, 10.5% threonine, 7.0% phenylalanine, and 5.5% other) were provided for the participants to be taken with water or milk, and they were instructed to take the 4-gram supplement once a day every day for 4 weeks.
15882621|NCT03784495|Combination Product|Essential Aminoacids + melatonin|4g/day of Essential Aminoacids during breakfast + 1 mg/day of Melatonin 30 minutes before sleep. Packets of powdered amino acid supplements (42.0% leucine, 14.0% lysine, 10.5% valine, 10.5% isoleucine, 10.5% threonine, 7.0% phenylalanine, and 5.5% other) were provided for the participants to be taken with water or milk, and they were instructed to take the 4-gram supplement once a day every day for 4 weeks.
15882622|NCT03784495|Other|Placebo|an isocaloric amount of maltodextrin with the same flavor and appearance as the intervention product
15882623|NCT03784469|Other|Changing body position in bed|The first hour:Supine position. The second hour:lateral position (right or left). The third hour:Supine position. The fourth hour:lateral position (right or left).
15882747|NCT03783637|Other|Whole grain oats|A meal containing whole grain oats
15882624|NCT03784456|Dietary Supplement|25% protein|Compared to usual group of 15% protein in meals, intervention group will receive 25% protein contents under same estimated calorie menus. Protein may come from either egg, meat, fish, soy, or milk product.
15882625|NCT03784456|Dietary Supplement|15% protein|Designed as comparator , compared to empirical arm of 25% protein in meals, intervention group will receive 15% protein contents under same estimated calorie menus. Protein may come from either egg, meat, fish, soy, or milk product.
15882626|NCT03784443|Drug|Iluvien 0.19 MG Drug Implant|Fluocinolone Acetonide Sustained Release Intravitreal Implant at Baseline Visit
15882627|NCT03784443|Drug|Ranibizumab Injection [Lucentis]|Monthly PRN intravitreal injections
15882628|NCT03784443|Procedure|Sham Intravitreal Injection|Sham injection without penetrating needle and without drug delivery at baseline visit.
15882629|NCT03784430|Procedure|Immediate dental implant placement|Tooth will be extracted and a dental implant will be positioned at the same time.
15882630|NCT03784430|Procedure|Immediate dental implant placement with CTG|Tooth will be extracted and a dental implant will be positioned at the same time with a connective tissue graft.
15882631|NCT03784417|Device|EUS-guided laser ablation|EUS-guided LA will be performed with an endoscopic ultrasound guided approach using a 1064-nm wavelength laser with the insertion of a 300-μm optical fiber through a 22-gauge flexible needle that is inserted in the working channel of the echoendoscope.
15882632|NCT03784404|Procedure|Transvaginal aspiration|under sedation transvaginal insertion of spinal needle through the cul de sac under ultrasonographic guidance to reach cyst cavity followed by aspiration of the chocolate material followed by irrigation of the cyst cavity with normal saline solution till complete elimination of the chocolate material
15882633|NCT03784404|Procedure|transvaginal aspiration and surgicel injection|under sedation transvaginal insertion of spinal needle through the cul de sac under ultrasonographic guidance to reach cyst cavity followed by aspiration of the chocolate material followed by irrigation of the cyst cavity with normal saline solution till complete elimination of the chocolate material follwed by insertion of 3-4 pieces of small surgicel inside the cyst cavity
15882634|NCT03784404|Drug|Intracytoplasmic sperm injection|"Candidates for the standard long protocol received triptorelin 0.1 mg Subcutanous daily starting from day 21 of the previous cycle. On the second day of the stimulation cycle, pituitary downregulation was confirmed. Controlled ovarian stimulation was then started on day 3 using Human Menopausal Gonadotropin (Menogon; Ferring). The dose of gonadotropin was individualized. The patients were monitored with serial ultrasound and serum E2. When at least 3 follicles reached 18 mm, ovulation was triggered using Human Chorionic Gonadotropin 10000 IU (Epifasi 10000 IU; Eipico, Tenth of Ramadan, Egypt) IM and ovum pickup was performed 35 hours later.
~All cases received luteal support in the form of progesterone 400 mg twice daily. Embryo transfer was done on day 3 or 5 using Labotect semi-rigid catheter (Labotect GmbH, Kassel area, Germany) under abdominal ultrasound guidance."
15882635|NCT03784391|Drug|Lampit (Nifurtimox, BAYA2502)|Nifurtimox is a drug already approved in some South American countries since more than 45 years
15882636|NCT03784378|Drug|RXDX-105|RXDX-105 capsules will be administered orally on a continuous daily dosing regimen. Patients will be continue to be treated at the dose level they were previously treated on during participation on Study of RXDX-105.
15882637|NCT03784365|Drug|One dose of Cefo-perazone Sulbactum|Antibiotic
15882638|NCT03784352|Device|Virtual Reality|A calming virtual reality game will be played
15882639|NCT03784339|Other|Physiotherapy + education|Participants will take part in a 30 minute education session surrounding fear of movement and catastrophizing thoughts. They will then receive standard care, which will involve strength exercises and taping if needed.
15882640|NCT03784339|Other|Physiotherapy|Standard physiotherapy care
15882641|NCT03784326|Drug|Atezolizumab|Given IV
15882642|NCT03784326|Procedure|Conventional Surgery|Undergo surgical resection
15882643|NCT03784326|Drug|Fluorouracil|Given IV
15882644|NCT03784326|Drug|Oxaliplatin|Given IV
15882645|NCT03784313|Procedure|skin repair by axillary perforator flaps|"Perforators flaps (PF) of the axillary region for the coverage the axillary defect left after radical excision for axillary Hidradenitis Suppurativa.
~Perforated flap surgery does not involve any procedure or manipulation that may alter the biological characteristics and/or structural properties of the tissue (use autologue pur). A usual dressing is performed daily until complete healing."
15882646|NCT03784313|Procedure|skin repair by secondary wound healing|Secondary intention wound healing (SIWH) for the coverage the axillary defect left after radical excision for axillary Hidradenitis Suppurativa
15882647|NCT03784300|Drug|50 mg PTI-125|PTI-125 50 mg Oral Solution
15882648|NCT03784300|Drug|100 mg PTI-125|PTI-125 100 mg Oral Solution
15882649|NCT03784300|Drug|200 mg PTI-125|PTI-125 200 mg Oral Solution
15882650|NCT03784287|Drug|AX 250|Chimeric fusion of recombinant human alpha-N-acetylglucosaminidase and truncated human insulin-like growth factor 2 (rhNAGLU-IGF2)
15882651|NCT03784274|Behavioral|Stakeholder analysis|"• INCLUSION CRITERIA FOR NET MAPPING ACTIVITIES: Those respondents who are directly involved or knowledgeable about pneumonia related policy environment in the country/province.
~Respondents who consent to participate in the study.
~Respondents belonging to Sindh, Punjab, Baluchistan, KPK and Islamabad.
~EXCLUSION CRITERIA:
~• Respondents belonging to Gilgit-Baltistan (GB), Azad Jammu and Kashmir (AJK) and Federally Administered Tribal Area (FATA). Reasons of their exclusion are newly developed governance system (GB), separate governance (AJK) and security threat (FATA)."
15882652|NCT03784261|Drug|"Drug: Salirumab"|To examine the effects of salirumab in RA patients
15882653|NCT03784261|Drug|"Drug: Tocilizmab"|To examine the effects of tocilizmab in RA patients
15882654|NCT03784261|Drug|"Drug: Abatacept"|To examine the effects of abatacept in RA patients
15882655|NCT03784248|Other|blood donation and isolation of leuco-platelet layers|patients donating blood. Blood bags will be treated and leuco-platelet coatings will be sent to Nice
15882657|NCT03784222|Drug|Blonanserin|patients were prescribed blonanserin 4-24mg/d according to the patients' response and tolerability
15882658|NCT03784222|Other|MRI and serum BDNF|60 patients receive MRI and serum BDNF test, 60 controls receive MRI, 20 of the 60 controls receive serum BDNF test
15882659|NCT03784209|Diagnostic Test|The diagnosis of Artificial Intelligence and endoscopist|When suspected lesion is observed using pCLE, endoscopist and AI will make a diagnosis independently. In addition, the endoscopist can not see the diagnosis of AI.
15882660|NCT03784196|Other|Conservative rehabilitation|WAD participants underwent 2-weeks rehabilitation.
15882661|NCT03784183|Other|Cognitive Stimulation (CS)|CS consists of a wide range of structured activities aimed at the general improvement of social functioning and the maintenance of different cognitive functions. It is a non-specific in-group approach that places particular emphasis on social interactions.
15882662|NCT03784170|Device|FemPulse System|Device therapy with the FemPulse System
15882663|NCT03784144|Diagnostic Test|Biering-Sorensen Test and Prone Plank Test|All patients will be encouraged to achieve the maximum time to task failure, stopped only by muscular fatigue or pain precluding to maintain the position.
15882664|NCT03784131|Drug|P-TEV|Replacement of vein with failing valves with personalized tissue engineering vein containing functional valves
15882665|NCT03784118|Diagnostic Test|Ultrasonography|Ultrasonography is used to evaluate the change in artery size after arterial catheterization and to assess the complication in children
15882666|NCT03784105|Drug|Codeine Phosphate|30 mL of codeine phosphate 10mg/5mL
15882667|NCT03784105|Drug|Siripus simplex|Sugar syrup
15882668|NCT03784092|Other|feedback|feedback by electronic pedometers regarding patient mobility while undergoing labor induction
15882669|NCT03784079|Drug|GSK3640254|GSK3640254 will be available with dosing strengths of 5 mg, 20 mg, and 100 mg to be administered as an oral capsule along with 240 mL of water.
15882670|NCT03784079|Drug|Placebo matching GSK3640254 Mesylate salt|Placebo to match GSK3640254 Mesylate salt will be given as an oral capsule along with 240 mL of water
15882671|NCT03784066|Drug|Durvalumab|"All patients will be treated with postoperative radiotherapy (66 Gy in standard fractionation).
~In case of positive section margins or extracapsular extension, 3 cycles of cisplatin 100 mg/msq on days 1, 22, and 43 will be added to standard fractionation radiotherapy (66 Gy).
~Durvalumab monotherapy (1500 mg) will be administered via IV infusion day -14 and at the start of radiation therapy, with repeat administration every 4 weeks at fixed dose for a total of 6 cycles postoperative."
15882672|NCT03784066|Combination Product|Durvalumab + Tremelimumab|"All patients will be treated with postoperative radiotherapy (66 Gy in standard fractionation).
~In case of positive section margins or extracapsular extension, 3 cycles of cisplatin 100 mg/msq on days 1, 22, and 43 will be added to standard fractionation radiotherapy (66 Gy).
~Durvalumab + Tremelimumab combination therapy: Tremelimumab (75 mg) will be administered via IV infusion day -14 and at the start of radiation therapy, with repeat administration every 4 weeks at fixed dose for a total of 3 cycles postoperative, Durvalumab (1500 mg) will be administered via IV infusion day -14 and at the start of radiation therapy, with repeat administration every 4 weeks at fixed dose for a total of 6 cycles postoperative."
15882673|NCT03784053|Other|Immersive virtual reality|At the start of every session, the participants' top five occupational problems will be reviewed, and a list of apps corresponding to the desired occupational problem will be offered through the immersive virtual reality device (Oculus Go). There will be eight 30-minute virtual reality sessions.
15882674|NCT03784040|Drug|OTSGC-A24|OTSGC-A24 is administered as a subcutaneous (under the skin) injection. Nivolumab and ipilimumab are administered by intravenous (IV) infusion, meaning the drug is given through a catheter in a vein. A pump will be used to ensure the correct amount of medicine is given through the catheter. The nivolumab and ipilimumab infusions each take about 30 minutes. There will be a break of about 30 minutes in between the nivolumab and ipilimumab infusions (if given on the same day). OTSGC-A24 and nivolumab are administered every 2 weeks, while ipilimumab is administered every 6 weeks.
15882675|NCT03784040|Drug|Nivolumab|OTSGC-A24 is administered as a subcutaneous (under the skin) injection. Nivolumab and ipilimumab are administered by intravenous (IV) infusion, meaning the drug is given through a catheter in a vein. A pump will be used to ensure the correct amount of medicine is given through the catheter. The nivolumab and ipilimumab infusions each take about 30 minutes. There will be a break of about 30 minutes in between the nivolumab and ipilimumab infusions (if given on the same day). OTSGC-A24 and nivolumab are administered every 2 weeks, while ipilimumab is administered every 6 weeks.
15882676|NCT03784040|Drug|Ipilimumab|OTSGC-A24 is administered as a subcutaneous (under the skin) injection. Nivolumab and ipilimumab are administered by intravenous (IV) infusion, meaning the drug is given through a catheter in a vein. A pump will be used to ensure the correct amount of medicine is given through the catheter. The nivolumab and ipilimumab infusions each take about 30 minutes. There will be a break of about 30 minutes in between the nivolumab and ipilimumab infusions (if given on the same day). OTSGC-A24 and nivolumab are administered every 2 weeks, while ipilimumab is administered every 6 weeks.
15882677|NCT03784027|Device|CamAPS FX|"CamAPS FX closed loop system comprises:
~Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
~Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
~An Android smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor
~Cloud upload system to monitor CGM/insulin data"
15882678|NCT03784027|Other|Sensor augmented therapy|Study insulin pump and study CGM.
15882679|NCT03784014|Drug|Nilotinib|Target: KIT, PDGFRA, CSF1R Nilotinib will be administered orally, 400 mg twice daily on a continuous basis. A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation.
15882680|NCT03784014|Drug|Ceritinib|Target: ALK, ROS. Ceritinib will be administered orally, 450mg once daily on a continuous basis. A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation.
15882681|NCT03784014|Drug|Capmatinib|Target: MET. Capmatinib will be administered orally, 400mg twice daily on a continuous basis. A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation.
15882682|NCT03784014|Drug|Lapatinib|Target: ERBB2, EGFR. Lapatinib will be administered orally, 1500mg once daily on a continuous basis. A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation.
15882683|NCT03784014|Drug|Trametinib|Target: KRAS, NRAS, HRAS, PTPN11, NF1, MAP2K. Trametinib will be administered orally, 2 mg once daily on a continuous basis. A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation.
15882748|NCT03783637|Other|Whole grain wheat|A meal containing whole grain wheat
15882684|NCT03784014|Combination Product|Trametinib and Dabrafenib|"Target: KRAS, NRAS, HRAS, PTPN11, NF1, MAP2K, BRAF. Trametinib will be administered orally, 2mg once daily on a continuous basis. Dabrafenib will be administered orally, 150mg twice daily, on a continuous basis.
~A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation."
15882685|NCT03784014|Combination Product|Olaparib and Durvalumab|Target: PDL1, PARP. Olaparib will be administered orally, 300mg twice daily on a continuous basis. Dabrafenib will be administered intraveinously, 1500mg on day 1 every 4 weeks. A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation.
15882686|NCT03784014|Drug|Palbociclib|"Target: CDK4, CDK6. Palbociclib will be administered orally, 125mg once daily, 3 weeks on/1 week off.
~A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation."
15882687|NCT03784014|Drug|Glasdegib|Target: SMO. Glasdegib will be administered orally, 300 mg once daily on a continuous basis. A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation.
15882688|NCT03784014|Drug|TAS-120|Target: FGFR. TAS-120 will be administered orally, 20 mg once daily on a continuous basis. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation.
15882689|NCT03784014|Other|Next Generation sequencing exome|Both frozentumor material (archived or newly obtained) and blood sample collection will be used for genetic profiling
15882690|NCT03784001|Behavioral|Gratitude + No Expectations Intervention|Participants will be emailed six different times, once every two days, with a link to an anonymous Google form. Each Google form will instruct participants to type a short gratitude list of up to five items. Additionally, the first form will include a demographics questionnaire and the first and sixth forms will include questionnaires assessing all outcomes of interest
15882691|NCT03784001|Behavioral|Gratitude + Expectations Intervention|"Participants will be emailed six different times, once every two days, with a link to an anonymous Google form. Each Google form will instruct participants to type a short gratitude list of up to five items. Participants will have a statement at the top of their Google form about the benefits of gratitude. Examples of these statements are: Practicing gratitude may increase social connectedness and Cultivating gratitude was shown to improve school satisfaction in a UK sample of students. Additionally, the first form will include a demographics questionnaire and the first and sixth forms will include questionnaires assessing all outcomes of interest"
15882692|NCT03784001|Behavioral|Events Control Intervention|Participants will be emailed six different times, once every two days, with a link to an anonymous Google form. Each Google form will instruct participants to type a list of up to five items about events from their day. Additionally, the first form will include a demographics questionnaire and the first and sixth forms will include questionnaires assessing all outcomes of interest.
15882693|NCT03783988|Combination Product|DHEA and TRIAC|The new topical gel contains dehydroepiandrosterone (DHEA) and triiodothyroacetic acid (TRIAC)
15882694|NCT03783975|Genetic|Simplified Cascade Screening|Screening of the KCNQ1 Thr224Met variant for family members of probands
15882695|NCT03783962|Behavioral|Active Intervention - Cooking|"Key behavioral strategies to facilitate making sustained changes in dietary habits and activity patterns are introduced, promoted and reinforced throughout the program. In-person sessions facilitated by an interventionist provide the group meetings. The program provides 24 weekly facilitated group sessions over 6 months. In addition to attending weekly classes, participants will track food intake, exercise, and weight. Participants will share online tracking diaries with the group facilitator who will offer individualized feedback on individual progress.
~Twelve cooking classes will be run every other week after the in-person weight loss meetings."
15882696|NCT03783962|Behavioral|Demonstrations - Cooking|The Demonstrations group will receive the exact same behavioral weight loss intervention as the cooking group. The only difference is that this group will attend cooking demonstrations as opposed to actively cooking.
15882697|NCT03783949|Drug|Ganetespib|Ganetespib dose during chemotherapy will be 150mg/m² (q3w) Ganetespib dose during maintenance treatment will be 100mg/m² (q1w)
15882698|NCT03783949|Drug|Niraparib|Niraparib starting dose during maintenance treatment will be 200mg or 300mg depending on subject's body weight and subject neutrophil count (QD)
15882699|NCT03783949|Drug|Carboplatin|In combination with Gemcitabine: Carboplatin dose will be AUC4 (q3w) In combination with Paclitaxel: Carboplatin dose will be AUC5 (q3w)
15882700|NCT03783949|Drug|Paclitaxel|Paclitaxel dose will be 175mg/m² (q3w)
15882701|NCT03783949|Drug|Gemcitabine|Gemcitabine dose will be 1000mg/m² (q3w, d1 & d8)
15882702|NCT03783936|Drug|Oxaliplatin|Oxaliplatin 85 mg/m2
15882703|NCT03783936|Drug|Leucovorin|Leucovorin 400 mg/m2
15882704|NCT03783936|Drug|5 fluorouracil|5 fluorouracil 400 mg/m2 bolus and 2400 mg/m2 continuous infusion
15882705|NCT03783936|Drug|Trastuzumab|Trastuzumab 6 mg/kg loading dose C1D1 then 4 mg/kg Day 1
15882706|NCT03783936|Drug|Avelumab|Avelumab 800 mg
15882707|NCT03783923|Drug|Deflazacort|Deflazacort tablet will be administered as per the dose and schedule specified in the arm.
15882708|NCT03783910|Drug|GRT9906|One prolonged-release tablet containing 40 mg of GRT9906
15882709|NCT03783910|Drug|Placebo|Placebo matching GRT9906 tablets
15882710|NCT03783897|Drug|EDP-305|Subjects will receive EDP-305 on on Days 11 through 21 of cycle 3
15882711|NCT03783897|Drug|Oral Contraceptive|Subjects will receive active Oral Contraceptive on Days 1-21 and inert OC on Days 22-28 of cycles 1, 2 and 3
15882712|NCT03783884|Device|Diaphragm Pacing Therapy|Transvenous phrenic nerve stimulation to induce diaphragm contraction.
15882713|NCT03783871|Device|Microwave ablation|Subjects will be treated with microwave ablation.
15882714|NCT03783858|Device|P200TE|OCT images
15882715|NCT03783845|Combination Product|amoxicillin 500mg and metronidazole 400mg|metronidazole 400mg and amoxicillin 500mg three times daily for two weeks
15882716|NCT03783832|Other|OCT ANGIOGRAPHY DATA|Follow-up of diabetic macular edema treated by Aflibercept (EYLEA®) with OCT angiography
15882717|NCT03783819|Other|Hypericum perforatum oil|Ointment containing Hypericum perforatum oil
15882718|NCT03783819|Other|Placebo|Ointment containing plant oils used in Hypericum perforatum oil production and dye
15882749|NCT03783624|Behavioral|Hypnosis|A 6 session course of individual hypnosis therapy will be offered.
15882750|NCT03783624|Behavioral|Open label placebo|Ritual intake of 2 placebo capsules twice a day
15882719|NCT03783819|Procedure|SLS induced irritation|60 uL of 1% w/v sodium lauryl sulphate (SLS) will be applied to skin under occlusion by large Finn chamber for 24 hours as described in the guidelines by Standardization group of European Society of Contact Dermatitis. Procedure will be performed to specified skin sites, according to randomization protocol.
15882720|NCT03783819|Procedure|Tape-stripping|Skin barrier disruption will be induced by tape-stripping. Procedure will be performed to specified skin sites, according to randomization protocol.
15882721|NCT03783819|Procedure|UV radiation|UV radiation will be used to induce skin erythema and damage. Procedure will be performed to specified skin sites, according to randomization protocol.
15882722|NCT03783819|Procedure|Intact skin|Healthy, intact skin. Procedure will be performed to specified skin sites, according to randomization protocol.
15882723|NCT03783806|Diagnostic Test|Posturography measurements|Determination of functional status, Posturography measurements, postural tests
15882724|NCT03783793|Behavioral|Mindfulness Training App|Mindfulness training in the study was performed using a new app called Wildflowers. With this app participants were able to choose and complete a variety of guided meditations over the 3 week training period. Wildflowers includes guided meditations such as breathing, body scans, and open monitoring practices and also provides didactic content in the form of lessons and information about the benefits of mindfulness training.
15882725|NCT03783793|Behavioral|Cognitive Training With 2048|The training app for the control condition was based on an open source code for a popular cognitive training app called 2048 that is marketed as a fun and relaxing puzzle game. Within 2048, participants slide numbered tiles around a grid, matching tiles of the same value. Instead of tiles disappearing, as in Candy Crush or other similar grid-sliding games, matching 2 numbered tiles in 2048 combines them into 1 new tile displaying the sum of the previous 2 numbers. For example, two 2-tiles linked side-by-side become a 4-tile, whereas 2 matched 4-tiles become an 8-tile, and so on. The goal is to match tiles until the sum of 2048 is reached on a single tile. There is no time limit.
15882726|NCT03783780|Device|INVSENSOR00031|Noninvasive pulse oximeter sensor
15882727|NCT03783767|Behavioral|Leadership Intervention|Grade 6/7 teachers will take part in a workshop on developing transformational leadership among their Grade 6/7 students, and provide teachers with a 4-week training program. Teachers will implement a 4-week leadership development component to their Grade 6/7 students. Grade 6/7 students will then deliver a 10-week peer-led FMS program to Grade 3/4 students. The Grade 6/7 peer leaders will lead 2 x 30 min sessions per week during physical education classes, recess, or lunch times. In weeks two and three, peer leaders will be observed by members of the research team and provided with feedback using a structured checklist regarding their delivery in the session. Mid-way through the 10-week program teachers will deliver a booster leadership training component to the Grade 6/7 peer-leaders.
15882728|NCT03783754|Drug|telmisartan 20 mg + amlodipine 2.5mg + indapamide 1.25mg|low-dose combination therapy
15882729|NCT03783754|Drug|Placebo oral capsule|matched placebo
15882730|NCT03783741|Behavioral|Questionnaire|Interview
15882731|NCT03783728|Drug|Rifapentine 600 mg orally|Once a week for 12 weeks using Video Directly Observed Therapy
15882732|NCT03783728|Drug|Isoniazid 900 mg orally|Once a week for 12 weeks using Video Directly Observed Therapy
15882733|NCT03783728|Drug|Pyridoxine 50 mg orally|Once a week for 12 weeks using Video Directly Observed Therapy
15882734|NCT03783715|Drug|Ketoprofen|Ketoprofen 200 mg ER, taken orally, once a day for 6 months. If medication, if obtained from a compound pharmacy, dose will be 210 mg ER, taken orally once a day for 6 months.
15882735|NCT03783702|Drug|OxyCODONE 5 Mg (milligram) Oral Tablet|Oxycodone will be the second-line treatment in the control group and the third-line treatment in the experimental group.
15882736|NCT03783702|Drug|Ibuprofen 600 Mg (milligram) Oral Tablet|Patients in the experimental group will receive ibuprofen 600mg as the second-line analgesic.
15882737|NCT03783702|Drug|Acetaminophen 650 MG (milligram) Oral Tablet|All patients will receive acetaminophen as the first-line analgesic.
15882738|NCT03783689|Device|SPRINT Peripheral Nerve Stimulation (PNS) System|"The SPRINT System delivers mild electrical stimulation to nerves in the residual limb. The SPRINT System includes two small wires (called Leads) that are placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator)."
15882739|NCT03783676|Drug|Remifentanil|Receive remifentanil bolus and infusion guided by an algorithm.
15882740|NCT03783676|Drug|Normal saline|Receive normal saline bolus and infusion guided by the remifentanil algorithm.
15882741|NCT03783663|Behavioral|Misfit Shine 2|The intervention group was given a Misfit Shine 2 to monitor sleep throughout the 12-week intervention period. Participants were instructed to wear the device on the wrist, which is better for capturing sleep than the other wear locations. Participants were instructed on how to self-monitor total sleep time and select a goal for that behavior. Further, participants were asked to view feedback on their sleep time daily on the Misfit smartphone app, which they used to monitor their progress toward achieving their behavioral goals.
15882742|NCT03783650|Behavioral|Control condition|Practices will submit control data and not receive centralized data feedback. They will also begin tracking data on a HTN registry and learn how to ensure accurate BP measurement is completed in their clinic.
15882743|NCT03783650|Behavioral|QIC with PCP and without subspecialist|During this phase, practice will begin working on improving HTN practices within their clinic via a QIC, while the other cohort will act as a control (usual care) with data collection. They will attend an initial 1-day interactive video webinar learning session where they will learn QI methodology, enhance and practice QI skills, identify local 30-60 day aims to improve local HTN practices and increase their understanding of pediatric HTN. They will also begin tracking data on a HTN registry and learn how to ensure accurate BP measurement is completed in their clinic. They will participate in QI coaching, monthly video conferences, and monthly mini-root cause analyses (Mini-RCAs).
15882744|NCT03783650|Behavioral|QIC with Subspecialist|Practices will integrate their HTN subspecialist into the QIC and focus on issues at the boundary of PCP and subspecialty care (e.g. pre-referral work-up, communication across providers, and time for next available appointment).
15882745|NCT03783650|Behavioral|Hub and Spoke co-management|Practices will continue QIC components and implement a hub and spoke model, where the PCP diagnoses and provides definitive management for pediatric HTN with subspecialist support.
15882778|NCT03783442|Drug|Capecitabine|1000 mg/m2 orally (PO) twice daily (BID) on Days 1 to 14 Q3W
15882751|NCT03783611|Behavioral|MyPlan 2.0.|eHealth intervention to increase physical activity in older adults. MyPlan 2.0 consists of five website visits. The first website visit contains pre- and post-intentional processes. The following four website visits contains mainly post-intentional processes. During the first website, participants fill in a questionnaire about their physical activity levels, and receive feedback. Furthermore, they are asked to make an action plan and think about barriers to reach their activity goals and possible solutions to tackle these barriers. During the other four website visits, participants receive feedback about their behavior change process and their action plan (did they reach their goal)? During these website visits, they can adapt their action plans.
15882752|NCT03783598|Behavioral|Person centered, occupation based intervention support with problem solving therapy|This program that was developed from the occupational therapy perspective which is person centered and occupation based for T2D intervention was designed as 6 modules. The intervention group received person centered, occupation based intervention support with problem solving therapy as 6 modules. The control group had not any intervention, just had a education about effect of diabetes on life.
15882753|NCT03783585|Behavioral|Cognitive behavioral therapy for insomnia|The web-based CBT-I program is a 6-week interactive, online program that delivers typical CBT-I treatment techniques of stimulus control, sleep restriction, behavioral modifications, and cognitive restructuring.
15882754|NCT03783585|Behavioral|Cognitive behavioral therapy for insomnia + biweekly support|Individuals randomized into the CBT-I + biweekly support will participate in CBT-I as described as well as a biweekly phone call or video call with research personnel for motivational interviewing.
15882755|NCT03783572|Other|Clinical evaluation|For the control group : only one clinical evaluation : search for non-inclusion criteria and manual laterality score
15882756|NCT03783572|Other|Clinical evaluation and Instrumental evaluation|For the patient : The standard clinical examination to evaluate movement : pain, motive power, spasticity plus Edinburgh's laterality score and Sensitivity deficiency by the Erasmus Nottingham Sensory Assessment (EmNSA) score and the evaluation of the cognitive function An encephalic MRI An instrumental evaluation : with concomitant recording of 3D kinematic data, surface and intramuscular EMG of the flexor and elbow extensor muscles, and EEG during active elbow extension, paretic and non-paretic movements.
15882757|NCT03783559|Drug|TACE|TACE
15882758|NCT03783559|Drug|chemotherapy±target therapy|chemotherapy±target therapy
15882759|NCT03783546|Device|Acupuncture|Acupuncture is a complementary therapy in which, hair-thin, sterile disposable needles are inserted into various spots on your skin, with the goal of affecting body's natural healing system
15882760|NCT03783546|Other|Usual Care|the current standard of care with non-hormonal pharmacotherapy of western medicine
15882761|NCT03783533|Behavioral|Behavioral Activation|Intervention: Behavioral Activation (BA) therapy is based on a functional analytic model of depression that highlights the need for increased positive reinforcement (rewards) and decreased anhedonia, or diminished motivation to seek rewards, to maintain normal mood. BA is significantly more effective than Cognitive Behavioral Therapy and comparable to antidepressant medication in reducing depressive symptoms among depressed adults (Dimidjian et al., 2006). McCauley (senior mentor) et al. (2016) adapted BA for adolescents to target anhedonia, effective problem solving and avoidant behaviors with peers, family, and school. McCauley's findings and others show BA is a promising intervention for adolescent MDD (Chu et al., 2009; Cuijpers et al.,, 2007; McCauley et al., 2015; Ritschel et al., 2011). BA focuses on targeting ideographically identified avoidant behaviors and rewarding experiences that affect mood.
15882762|NCT03783520|Device|Er,Cr:YSGG Laser|Er,Cr:YSGG Laser is used for disinfection of the root canals.
15882763|NCT03783520|Other|Sodium hypochlorite|Sodium hypochlorite is used for disinfection of the root canals
15882764|NCT03783507|Behavioral|Order 1|"Meal Order 1:
~Meal Session 1 participant receives meal 1 (3 low-ED, 0 medium-ED, 2 high-ED) Meal Session 2 participant receives meal 2 (3 low-ED, 1 medium-ED,1 high-ED) Meal Session 3 participant receives meal 3 (1 low-ED, 2-medium ED, 2 high-ED) Meal Session 4 participant receives meal 4 (1 low-ED, 3 medium-ED, 1 high-ED)"
15882765|NCT03783507|Behavioral|Order 2|"Meal Order 2:
~Meal Session 1 participant receives meal 2 (3 low-ED, 1 medium-ED,1 high-ED) Meal Session 2 participant receives meal 3 (1 low-ED, 2-medium ED, 2 high-ED) Meal Session 3 participant receives meal 4 (1 low-ED, 3 medium-ED, 1 high-ED) Meal Session 4 participant receives meal 1 (3 low-ED, 0 medium-ED, 2 high-ED)"
15882766|NCT03783507|Behavioral|Order 3|"Meal Order 3:
~Meal Session 1 participant receives meal 3 (1 low-ED, 2-medium ED, 2 high-ED) Meal Session 2 participant receives meal 4 (1 low-ED, 3 medium-ED, 1 high-ED) Meal Session 3 participant receives meal 1 (3 low-ED, 0 medium-ED, 2 high-ED) Meal Session 4 participant receives meal 2 (3 low-ED, 1 medium-ED,1 high-ED)"
15882767|NCT03783507|Behavioral|Order 4|"Meal Order 4:
~Meal Session 1 participant receives meal 4 (1 low-ED, 3 medium-ED, 1 high-ED) Meal Session 2 participant receives meal 1 (3 low-ED, 0 medium-ED, 2 high-ED) Meal Session 3 participant receives meal 2 (3 low-ED, 1 medium-ED,1 high-ED) Meal Session 4 participant receives meal 3 (1 low-ED, 2-medium ED, 2 high-ED)"
15882768|NCT03783494|Drug|Target control infusion with propofol|Target control infusion with propofol for patients with indications of sustaining very painful orthopedic emergency emergent procedures
15882769|NCT03783481|Device|Mobile community|Install an application (app) on subjects' smartphone. Subject's will join the mobile community using the application through which they can check their own and other members daily steps and communicate with each other.
15882770|NCT03783481|Other|No Mobile community|No Mobile community
15882771|NCT03783468|Other|decrease of sedation doses and switch of ventilator settings|tapering sedation doses (propofol) switch from assisted ventilation to pressure support ventilation
15882772|NCT03783455|Procedure|Non arthroscopic joint lavage|Instillation of 4 litters of cold physiological serum
15882773|NCT03783455|Procedure|Non arthroscopic joint lavage plus corticosteroid|Instillation of 4 litters of cold physiological serum followed by intraarticular injection of triamcinolone
15882774|NCT03783455|Procedure|Non arthroscopic joint lavage plus hyaluronic acid|Instillation of 4 litters of cold physiological serum followed by intraarticular injection of hyaluronic acid
15882775|NCT03783455|Procedure|Intraarticular injection of corticosteroid|Intraarticular injection containing 40 mg of triamcinolone acetonide.
15882776|NCT03783455|Procedure|Intraarticular injection of hyaluronic acid|Intraarticular injection containing 4 mL of a bioengineered hyaluronic acid.
15882777|NCT03783442|Drug|Cisplatin|60 to 80 mg/m2 intravenously (IV) on Day 1 once every 3 weeks (Q3W)
15882786|NCT03783416|Drug|Ixazomib (NINLARO®) capsules / Matching placebo capsules|Participants will be treated for a maximum of 24 months
15882790|NCT03783390|Behavioral|Exercise Intervention|Youth randomized to the active condition will participate in an organized exercise program. During the exercise program, adolescents will participate in a supervised structured exercise (treadmill walking/cycling on stationary bike) on 3 days equivalent to approximately 180 min/week of moderate-intensity exercise. The rationale for this dose of structured exercise is based on national (ADA) and international physical activity recommendations for youth of 60 minutes/day.
15882791|NCT03783390|Behavioral|Newsletter|"Families will receive a monthly newsletter with parenting tips, sample praise statements, and child-appropriate activities and recipes identical to what has been used in the work of leaders in the field of pediatric obesity. Previous research suggests that newsletter/mail interventions are well received by participants and are frequently included in federally funded health intervention studies."
15882792|NCT03783377|Drug|ARO-APOC3|single or multiple doses of ARO-APOC3 by subcutaneous (sc) injections
15882793|NCT03783377|Drug|sterile normal saline (0.9% NaCl)|calculated volume to match active treatment
15882794|NCT03783364|Radiation|Radiotherapy|Pre- or postoperative acellerated irradition in 5 fractions
15882795|NCT03783351|Genetic|CYP2C19 genotype testing|CYP2C19 genotype testing will be conducted in a designated central laboratory.
15882796|NCT03783338|Combination Product|Aerobic exercises and Vitamin D supplementation|"Aerobic exercises:
~Children in groups B and C will receive aerobic exercises in the form of bicycle ergometer and treadmill training for 15 min 3 days/week for 12 weeks. The procedure and goals of exercise will be explained to all children before starting the exercise program. The child will stop exercising immediately if he feels pain, fainting or shortness of breath.
~Vitamin D supplementation:
~Children in group C only will receive vitamin D supplementation in the form of an oral daily dose of vitamin D3 1000 IU (Cholecalciferol) for 12 weeks."
15882797|NCT03783325|Behavioral|UV Counseling|This is a sub-study that involves a behavioral intervention. Participants will wear a UV dosimetry for 3 weeks, return the device and receive feedback. After the feedback, they will re-wear the device for an additional 3 weeks.
15882798|NCT03783325|Other|UV Photo|Technically, this arm is a sub-study that does not involve an intervention. Patients are not receiving an intervention; they are simply providing data to the study team.
15882799|NCT03783325|Other|Biological Sample|Technically, this arm is a sub-study that does not involve an intervention. Patients are not receiving an intervention; they are simply providing data to the study team.
15882800|NCT03783312|Drug|placebo|250 ml saline will be administered 60 minutes before the onset of Electroconvulsive therapy procedure. All administrations will be applied through IV infusion over 60 minutes.
15882801|NCT03783312|Drug|paracetamol|1 g paracetamol will be administered 60 minutes before the onset of Electroconvulsive therapy procedure. All administrations will be applied through IV infusion over 60 minutes.
15882802|NCT03783312|Drug|ibuprofen|800 mg ibuprofen will be administered 60 minutes before the onset of Electroconvulsive therapy procedure. All administrations will be applied through IV infusion over 60 minutes.
15882803|NCT03783299|Diagnostic Test|Standard RDT and HS-RDT|All household members (residents and temporary visitors) aged 18 months and older will be invited to participate in an RDT and blood collection component. After consenting, the MTAT team will capture axillary temperature, and test each individual using both a standard RDT (SD Bioline Pf/Pv RDT) and HS-RDT (SD Bioline Malaria Ag P.f High Sensitive Cat# 05FK140)
15882804|NCT03783299|Diagnostic Test|Standard RDT and HS-RDT|All individuals will be invited to participate in an RDT and blood collection component. Informed consent will be obtained from all participants. After consenting, the PNs will capture axillary temperature, and test each individual using both a standard RDT (SD Bioline Pf/Pv RDT) and HS-RDT (SD Bioline Alere Malaria Ag Pf High Sensitive Cat #05FK140). Dried blood spots (DBS) will also be collected on all HRPs if deemed feasible.
15882805|NCT03783299|Drug|Artemether-lumefantrine|If found positive by standard RDT or HS-RDT, treatment will be administered, and women of reproductive age will be assessed as outlined in the protocol. All individuals who have provided informed consent, test positive by either HS-RDT or standard RDT, are ≥18 months old, are not pregnant or breastfeeding, and who do not have symptoms associated with severe malaria or another severe illness, will be offered an age-appropriate course of AL (age-specific blister packages) and SLD-PQ according to national treatment guidelines.
15882806|NCT03783299|Drug|Primaquine Phosphate|If found positive by standard RDT or HS-RDT, treatment will be administered, and women of reproductive age will be assessed as outlined in the protocol. All individuals who have provided informed consent, test positive by either HS-RDT or standard RDT, are ≥18 months old, are not pregnant or breastfeeding, and who do not have symptoms associated with severe malaria or another severe illness, will be offered an age-appropriate course of AL (age-specific blister packages) and SLD-PQ according to national treatment guidelines.
15882807|NCT03783286|Drug|Ivacaftor|Ivacaftor (Kalydeco®, Vertex Pharmaceuticals Inc.) was the first of a new class of drugs that improved CFTR gating dysfunction (2, 3, 4). For such mutations (G551D, G178R, S549N, S549R, G551S, G970R, G1244E, S1251N, S1255P, G1349D) that permit CFTR expression at the cell membrane but compromise its activity.
15882808|NCT03783273|Dietary Supplement|Vitamin D3|Single dose vitamin D3
15882809|NCT03783273|Combination Product|Whey protein-complex|Whey protein complex-bound vitamin D3
15882810|NCT03783273|Other|Water|500 mL water
15882811|NCT03783273|Other|Milk|500 mL milk
15882812|NCT03783273|Other|Juice|500 mL juice
15882813|NCT03783260|Other|Mediterranean diet|During both Mediterranean diet periods, participants will be provided with meals and snacks representative of the Mediterranean nutritional habits. Participants will be required to eat only the meals provided.
15882849|NCT03782974|Dietary Supplement|beta glucan|Following screening and enrollment, participants will be treated with 2 tablets (Proglucamune or placebo) per day for a total duration of 8 weeks. Each Proglucamune tablet contained ~100 mg ß-glucan derived from Baker's Yeast extract (Saccharomyces cerevisiae, cell wall), Reishi mushroom powder (Ganoderma lucidum), and Shitake mushroom powder (Lentinula edodes).
15882814|NCT03783247|Procedure|Pericapsular nerve group block|The regional block was performed with the patient in the supine position. A curvilinear low-frequency ultrasound probe (2-5MHz) was initially placed in a transverse plane over the AIIS and then aligned with the pubic ramus by rotating the probe counterclockwise approximately 45 degrees (Figs. 2, 3). In this view, the IPE, the iliopsoas muscle and tendon, the femoral artery, and pectineus muscle were observed. A 22-gauge, 80-mm needle was inserted from lateral to medial in an in-plane approach to place the tip in the musculofascial plane between the psoas tendon anteriorly and the pubic ramus posteriorly. Following negative aspiration, the local anesthetic solution (20ml of bupivacaine 0.25%) was injected in 5-mL increments while observing for adequate fluid spread in this plane for a total volume of 30 mL
15882815|NCT03783247|Procedure|Fascia Iliaca BLock|In supine position, a high frequency linear probe will be placed in the inguinal crease. Scan starting laterally from the femoral artery and nerve in inguinal crease to identify the sartorius muscle, tracing the muscle until it's origin to anterior superior iliac spine. The shadow of the bony of iliac crest & iliacus muscle will be seen, the end point of the injection is deep to the fascia iliaca and above the iliacus muscle in the lateral part of the iliacus muscle. After negative aspiration, 30 mL of 0.25 % of bupivacaine will be injected under the fascial plane incrementally, aspirating every 5 ml.
15882816|NCT03783221|Other|High-fat diet|The high-fat diet (51% fat, 27% carbohydrates, 21% proteins and 4.7 g fiber) will be administered for two weeks..
15882817|NCT03783221|Other|High-residue diet|The high-residue diet (19% fat, 62% carbohydrates, 16% proteins and 54.2 g fiber) will be administered for two weeks.
15882818|NCT03783208|Drug|G-CSF|Slow infusion of G-CSF into the endometrial cavity using a soft embryo transfer catheter.
15882819|NCT03783208|Other|Saline|Slow infusion of saline into the endometrial cavity using a soft embryo transfer catheter.
15882820|NCT03783195|Other|Sugar drink|A sugar drink made with 1.2 g/kg body weight of added sugar( 0.75g/kg body weight of fructose + 0.45g/kg body weight of glucose) and 24oz water
15882821|NCT03783182|Drug|Betamethason Sodium Phosphate|Glucocorticoid
15882822|NCT03783182|Drug|10% glucose solution|Glucose solution that can be used for injection, but in this case it is used perorally (one ml)
15882823|NCT03783169|Other|Cardiovascular Sonographic Assessment|Maternal sonographic vascular measurements assessing volume status, cardiac output, and systemic vascular resistance by means of inferior vena cava collapsibility/caval index (ICV CI), end-point septal separation (EPSS) for determining left ventricular ejection fraction (LVEF), cardiac output determination (stroke volume x heart rate), stroke volume variation, & radial artery resistance index) augments standard vital sign assessment (pulse pressure and systolic / diastolic predominance)
15882824|NCT03783156|Procedure|hot snare|polypectomy with hot snare
15882825|NCT03783156|Procedure|cold snare|polypectomy with cold snare
15882826|NCT03783130|Biological|VRC-HIVRGP096-00-VP|Trimer 4571 drug product is an investigational HIV vaccine which mimics the native HIV-1 envelope complex. This soluble HIV-1 envelope product consists of an HIV-1 envelope (Env) trimer variant, derived from clade A, strain BG505, with stabilizing mutations and engineered disulfide bonds, specifically recognized by broadly neutralizing antibodies and resists gp120 conformational change caused by CD4 binding.
15882827|NCT03783130|Other|Alum Adjuvant|Adjuvant is an aluminum hydroxide suspension (alum) mixed with Trimer 4571 to improve the immune response to the investigational vaccine.
15882828|NCT03783117|Device|Magnetic field treatment|The MBPL device for clinical trials is made with modification of an electromagnet: A bore of 10cm diameter was made to go through the frame and poles. The device can produce a magnetic field close to 1.0 T inside the bore, which is along the axis direction. The trial for each subject takes about 20-30 minutes. To start with, the subject's blood pressure is measured first as the baseline. Afterwards, the subject places his/her right arm into the bore of the electromagnet for treatment while the blood pressure is monitored with the left arm. The magnetic treatment lasts about 15 minutes and will lower the subject's blood pressure. In order to see how long the effect lasts, the subject needs to return and measure the blood pressure again 24 hours after the treatment. The clinical trials are non-invasive. There is no medicine or surgery involved.
15882829|NCT03783104|Dietary Supplement|B12 Supplement|Differential doses of vitamin B 12 supplementation in a two-armed randomised controlled trial
15882830|NCT03783091|Drug|Hydroxocobalamin|Single IV administration of Vitamin B12
15882831|NCT03783091|Drug|Placebo|Single IV administration of saline
15882832|NCT03783078|Drug|Pembrolizumab (MK-3475)|200 mg (adult participants) or 2 mg/kg (up to 200 mg; pediatric participants) on Day 1 of each 3-week cycle (Q3W). IV, Up to 35 administrations (approximately 2 years)
15882833|NCT03783065|Drug|Propranolol|Propranolol was administrated orally while keeping monitoring heart rate and blood pressure daily.
15882834|NCT03783065|Procedure|Laparoscopic splenectomy and pericardial devascularization|Including splenectomy and pericardial devascularizaion under laparoscopy
15882835|NCT03783065|Procedure|Endoscopic therapy|Either endoscopic variceal ligation (EVL) or cyanoacrylate injection was applied according to the condition of varices
15882836|NCT03783052|Device|SmartPill in fasted state|SmartPill administration in fasted state
15882837|NCT03783052|Device|SmartPill in fed state|SmartPill administration in fed state
15882838|NCT03783052|Other|Aspiration|Aspiration of gastrointestinal samples in fasted and fed state
15882839|NCT03783052|Other|Gastric emptying scintigraphy|Gastric emptying scintigraphy in fed state
15882840|NCT03783039|Device|SURGICEL Powder|Surgeon to perform surgical procedure according to standard of care. If randomized to SURGICEL Powder, the product will be be applied to the first appropriate TBS with mild or moderate bleeding in parenchyma or soft tissue where conventional methods of control (i.e. suture, ligature, cautery) are ineffective or impractical.
15882841|NCT03783039|Device|SURGICEL Original|Surgeon to perform surgical procedure according to standard of care. If randomized to SURGICEL Original, the product will be be applied to the first appropriate TBS with mild or moderate bleeding in parenchyma or soft tissue where conventional methods of control (i.e. suture, ligature, cautery) are ineffective or impractical.
15882843|NCT03783013|Other|High Lycopene Tomato Juice With Soy Germ Extract|Tomato juice made from high lycopene tomatoes with soy germ extract added
15882844|NCT03783013|Other|Low Lycopene Tomato Juice|Tomato juice made from low lycopene tomatoes with no soy germ extract added
15882845|NCT03783000|Drug|BI 425809|Treatment T
15882850|NCT03782961|Device|sodium lactate and combination of polymers|sodium lactate and combination of polymers (polycarbophil, carbomer and PVM / MA copolymer)
15882851|NCT03782948|Device|Standard gait training on BART without pelvic perturbations|The Balance Assisted Robot on Treadmill (BART) enables various types of gait training on treadmill with visual feedback. It interfaces to the pelvis of the walking subject in an actuated and admittance-controlled manner, thus providing transparent haptic interaction with negligible power transfer.
15882852|NCT03782948|Device|Robotised gait training with BART with pelvic perturbations|In addition to the standard gait training, the BART will deliver perturbations in the forward/backward and left/right direction.
15882853|NCT03782935|Dietary Supplement|Prenatal multivitamin mineral supplement|prenatal vitamin/mineral supplement with or without choline supplement
15882854|NCT03782922|Other|Exercise Training Program|10min of coordination and strength training (2-3x per week) during 2-6 weeks
15882855|NCT03782909|Behavioral|Behaviour change intervention|"The behaviour change intervention consists of;
~Feedback via an app based food diary
~Coaching with problem solving and implementation plans
~The intensive phase consists of 2 home visits and 4 phone calls and the use of the app The maintenance phase consists of use of the app if the PWCF wishes to continue using it"
15882856|NCT03782896|Other|acute postoperative pain|All patients assessed postoperative pain score in the recovery room and postoperative 2 month
15882857|NCT03782870|Diagnostic Test|echocardiography, lab tests|
15882858|NCT03782857|Behavioral|Intervention|Prevention of recurrent stroke, myocardial infarction and death Stepwise escalation of preventive medication Life style counselling including adherence to preventive treatment
15882859|NCT03782844|Device|Simple CPAP+Conventional fixed CPAP|Patients used simple CPAP and conventional fixed CPAP during overnight polysomnography.
15882860|NCT03782844|Device|Simple CPAP + Auto CPAP|Patients used simple CPAP and Auto CPAP during overnight polysomnography.
15882861|NCT03782831|Procedure|TACE|Hepatic intra-arterial infusion with lipiodol mixed with chemotherapy drugs (EADM, lobaplatin, and MMC), and embolization with polyvinyl alcohol particles (PVA).
15882862|NCT03782831|Drug|PD-1 antibody|3mg/kg intravenously every 2 weeks
15882863|NCT03782831|Drug|Placebos|intravenous injection every 2 weeks
15882864|NCT03782818|Drug|Olaparib|Olaparib up to 300 mg BID for 24 weeks
15882865|NCT03782805|Dietary Supplement|cholecalciferol (Euro-Pharm International, Canada)|The participants are randomly asked to take either a pill containing either a supplement of cholecalciferol or placebo for 3 times a week, within a period of 6 months
15882866|NCT03782805|Dietary Supplement|Placebo tablet|The participants are randomly asked to take either a pill containing either a supplement of cholecalciferol or placebo for 3 times a week, within a period of 6 months
15882867|NCT03782792|Drug|Spesolimab|Solution for infusion
15882868|NCT03782792|Drug|Placebo|Solution for infusion
15882869|NCT03782779|Other|Breathing program and regular exercise|This program will be supervised by a physical therapist and will include learning and performing a diaphragmatic-abdominal breathing, and incorporating the new breathing pattern to a upper and lower limbs regular exercises as well as to daily life activities.
15882870|NCT03782779|Other|Regular Exercise|Regular upper and lower limbs exercises supervised by a physical therapist
15882871|NCT03782766|Procedure|Piezocision|Piezocesion was performed by making 2 vertical incisions mesial and distal to the extraction space. Piezotome was inserted in the incisions previously made and bone cuts were done with a length up to mucogingival line and depth of 3 mm.
15882872|NCT03782740|Drug|Melatonin 10 mg|Melatonin capsule
15882873|NCT03782740|Drug|Placebo|Sugar pill manufactured to mimic Melatonin capsule
15882874|NCT03782740|Drug|Melatonin 20 mg|Melatonin capsule
15882875|NCT03782714|Device|Low-level laser therapy|It is a diode laser device that has laser set at low level, used for pain relief and inflammation reduction to induce healing
15882876|NCT03782701|Drug|Brimonidine tartrate ophthalmic solution 0.025%|One time dosing of brimonidine tartrate ophthalmic solution 0.025% (1 drop applied to ocular surface)
15882877|NCT03782701|Other|Sterile balanced saline solution|One time dosing of sterile balanced saline solution (1 drop applied to ocular surface)
15882878|NCT03782688|Diagnostic Test|FFRCT planner|Non-invasive post-PCI fractional flow reserve prediction
15882879|NCT03782675|Device|Control|The Air Barrier System will be deployed onto the surgical field, but the airflow will not be activated, so this is a sham control comparator.
15882880|NCT03782675|Device|Air Barrier System|The Air Barrier System is a device that uses localized clean air flow to shield a surgery site from ambient airborne microorganisms that are shed into the air from people present in the operating room.
15882881|NCT03782662|Drug|Itraconazole|Itraconazole capsules
15882882|NCT03782662|Drug|Verapamil|Verapamil tablets
15882883|NCT03782662|Drug|Rifampicin|Rifampicin capsules
15882884|NCT03782662|Drug|Midazolam|Midazolam oromucosal solution
15882885|NCT03782662|Drug|Placebo for RV521|Placebo for RV521 capsules
15882886|NCT03782662|Drug|RV521|RV521 capsules
15882887|NCT03782649|Device|Working Model 3.4NR|Investigational Medical Device collecting spectral Raman data from tissue
15882888|NCT03782636|Drug|Aldesleukin|"PROLEUKIN® 18 x 106 IU
~Powder for solution for injection or infusion"
15882889|NCT03782636|Other|Placebo|sterile diluent used for the aldesleukin preparation and 5% glucose
15882890|NCT03782623|Diagnostic Test|Analysis of eicosanoid profile prior to and after PRBC transfusion|Using liquid chromatography-mass spectrometry to analyze the eicosanoid profile in patient plasma and aliquoted of the PRBCs prior to and after PRBC transfusion.
15882891|NCT03782597|Behavioral|Semi-structured interviews or focus groups to explore families representations and strategies about their teenagers involved in radicalisation process|A sample of representative French families (parents, siblings, and persons identified as attachment figures) of adolescents or young adults (12-25 years old) involved in the radicalisation process will be asked to participate in semi-structured interviews or focus groups to explore their representations and strategies about radicalisation. It will be supplemented by genogram draw sociodemographic data.
15882892|NCT03782584|Other|modified pilates exercise|modified exercises from original pilates exercises.
15882893|NCT03782584|Other|daily life advises|they will be given daily life advises to prevent neck pain
15882896|NCT03782571|Device|etafilcon A Test 3|1-DAY ACUVUE® MOIST MULTIFOCAL
15882897|NCT03782571|Other|Control|Bare Eye
15882898|NCT03782558|Procedure|Surgical transection of transverse ligament|Standard therapy for CTS. An incision is made at the base of the palm of the hand. Then the transverse ligament is cut, which releases the compression of the median nerve and improves the symptoms.
15882899|NCT03782545|Device|Cutera truSculpt Device|The Cutera truSculpt Device uses radio frequency (RF) energy to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions, such as temporary reduction in the appearance of cellulite.
15882904|NCT03782519|Other|Dialysis frequency reduction|At initiation, frequency of dialysis will be reduced to 2 weekly sessions (incremental HD)
15882905|NCT03782519|Other|Frailty diagnosis|Before randomization, we will determine whether patients are frail. We will define frailty as the presence of at least three of the following five conditions: malnourished according to dietitian assessment and/or short form of Mini Nutritional Assessment (MNA), grip strength and gait speed using participants' scores on the SF-36 Physical Functioning (PF) scale, exhaustion using in the quality of life questionnaire SF-36 vitality (VT) scale and physical activity according to patient assessment (one single question)
15882906|NCT03782506|Behavioral|Interactive Music Therapy|Ten 45-minutes individual interactive music therapy (IMT) sessions delivered by a board-certified music therapist. Sessions start with music-guided breathing or humming. The music therapist then engages the participant in singing of familiar songs and co-created vocal or instrumental music improvisations. Discussion about the meaning assigned to songs and emotions expressed through the improvisations follow. Each session involves learning and practicing music-based techniques for the self-management of pain, anxiety, stress, mood, fatigue, and sleep disturbance as these are common opioid withdrawal symptoms. Psychoeducation about opioid tapering is provided and tapering challenges experienced by the patient will be actively addressed through music-based interventions.
15882907|NCT03782506|Behavioral|Verbal-based support|Ten 45-minute individual sessions delivered by a master's level clinician with training in counseling. The sessions are focused on patient-initiated conversations about their pain, life stressors and the impact on their daily life. The intervener provides nondirective, supportive care by offering supportive, validating statements and reflective listening. The intervener refrains from employing active suggestion, problem-solving or behavioral or cognitive therapy techniques. The verbal support sessions are aimed at providing an empathic, therapeutic environment to facilitate emotional expression and sharing of worries and fears. As in the IMT protocol, psychoeducation about opioid tapering will be included and will be considered the only active treatment factor for this intervention.
15882908|NCT03782493|Behavioral|the Enhanced Milieu Teaching-Sentence Focus|Caregivers in the treatment group (EMT-SF) will receive 66 EMT-SF intervention sessions at home over 18 months. They will be taught the intervention strategies using a manualized protocol (Teach-Model-Coach-Review).
15882909|NCT03782480|Drug|Intrarosa|Prasterone intravaginal inserts
15882910|NCT03782480|Drug|Placebos|Placebo intravaginal inserts
15882911|NCT03782467|Biological|ATOR-1015|Bispecific human monoclonal antibody targeting cytotoxic T-lymphocyte associated protein 4 (CTLA-4) and OX40 (also known as CD134)
15882912|NCT03782454|Diagnostic Test|Blood sampling|Blood samples taken every third hour during the first 48 hours of intensive care
15882913|NCT03782441|Device|Prototype 0.5|Investigational Medical Device collecting spectral Raman data from tissue
15882914|NCT03782428|Dietary Supplement|Probiotic|30 billions colony-forming unit (CFU) of a mixture of six viable strains including 107 mg of Lactobacillus acidophilus BCMC® 12130, Lactobacillus lactis BCMC® 12451, Lactobacillus casei subsp BCMC® 12313, Bifidobacterium longum BCMC® 02120, Bifidobacterium bifidum BCMC® 02290 and Bifidobacterium infantis BCMC® 02129
15882915|NCT03782428|Other|Placebo|Placebo samples produced were identical to the probiotics in term of taste and texture without live microorganisms.
15882916|NCT03782415|Drug|MN-166|MN-166 is an anti-inflammatory/neuroprotective agent. MN-166 distributes well to the CNS (Sanftner et al. 2009) and it is a selective inhibitor of certain cyclic nucleotide phosphodiesterases (PDE) and the pro-inflammatory cytokine, macrophage migration inhibitory factor (MIF). At clinically-relevant plasma or CNS concentrations, MN-166 selectively inhibits macrophage migration inhibitory factor (MIF) (Cho et al 2010) and, secondarily, PDE3, 4 and 10 (Gibson et al 2006).
15882917|NCT03782415|Drug|Temozolomide|Temozolomide is an oral chemotherapy drug. It is an alkylating agent used as a treatment of some brain cancers; and a first-line treatment for glioblastoma multiforme.
15882918|NCT03782402|Drug|Cannabinoids|Cannabinoids with different concentrations of THC and CBD
15882919|NCT03782389|Other|Preseason Periodic Health Examination Completion|all available players completed a mandatory PHE on one of three days during the first week of the season. Typically, the musculoskeletal and performance components of the PHE included: 1) anthropometric measurements; 2) medical history (i.e. previous injury history); 3) musculoskeletal examination tests; 4) functional movement and balance tests; 5) strength and power tests.
15882925|NCT03782363|Biological|Autologous CIK Dose level 1|Lymphocytapheresis of the autologous ex-vivo CIK cell expanded in the Cell factory at first level of dose 20.000.000 cell/kgs days 1 and 22
15882926|NCT03782363|Biological|Autologous CIK Dose level 2|Lymphocytapheresis of the autologous ex-vivo CIK cell expanded in the Cell factory at first level of dose 25.000.000 cell/kgs days 1 and 22
15882927|NCT03782363|Biological|Autologous CIK Dose level 3|Lymphocytapheresis of the autologous ex-vivo CIK cell expanded in the Cell factory at first level of dose 20.000.000 cell/kgs days 1 and 15
15882928|NCT03782363|Biological|Autologous CIK Dose level 4|Lymphocytapheresis of the autologous ex-vivo CIK cell expanded in the Cell factory at first level of dose 25.000.000 cell/kgs days 1 and 15
15882929|NCT03782350|Drug|Tranexamic Acid Dosage 1|Tranexamic Acid Dosage 1
15882930|NCT03782350|Drug|Tranexamic Acid Dosage 2|Tranexamic Acid Dosage 2
15882931|NCT03782337|Behavioral|multi-discipline disease management program|The multi-discipline disease management program consists of nursing lead education program, dietitian consultation, psychologist consultation and assessment, and cardiac rehabilitation program by physical therapist.The cardiovascular lead nurse will contact the patient by telephone within 3 days after discharge. An appointment at the outpatient clinic will be arranged within 1 to 2 weeks after discharge. The purposes of the telephone call are to reinforce self-management and recognition of HF symptoms and to screen post-discharge health status.
15882932|NCT03782311|Behavioral|motivation and and oral hygiene instructions|Motivation and oral hygiene instructions were received OHSE-high and OHSE-low groups. After showing the modified-Bass tooth brushing technique and interdental cleaning on the model, patients were followed up while brushing and flossing their teeth to correct misapplications. It was advised to brush teeth twice a day and use the interdental cleaning devices once a day.
15882933|NCT03782298|Device|Spyromite, Dynomite, Raptomite, Footprint Ultra PK SL|Observational, post-market, clinical follow-up study
15882934|NCT03782285|Procedure|sacrospinous Ligament Fixation|sacrospinous ligament suspension (SSLF) as a typical native tissue repair procedure is one of the most widely used vaginal procedures for correcting apical prolapse. Ischial spinous fascia fixation (ISFF) will be the replacement procedure if SSLF will not be accomplished by conventional surgical instruments due to unsatisfactory exposure of spinous fascia.
15882935|NCT03782272|Dietary Supplement|Enterade|enterade® (an amino acid-based oral rehydration solution [AA-ORS]) is a medical food product that consists of oral rehydration salts, natural flavor, steviol (sweetener), purified water, and a blend of amino acids that drive the uptake of water and electrolytes.
15882936|NCT03782272|Dietary Supplement|Placebo|a placebo solution containing natural flavor, steviol (sweetener), and purified water.
15882937|NCT03782259|Drug|dapagliflozin|Subjects will either receive 10mg tabs of dapagliflozin or identical looking placebo - inactive medication. Subjects have an equal chance of receiving dapagliflozin or placebo. Which treatment subjects receive is decided at random by a computer (purely by chance, like the tossing of a coin). Neither subjects nor the Study Site personnel will know which treatment subjects are assigned to. The study drug must be taken daily. The subject's other medications will not be changed by the study.
15882938|NCT03782259|Other|Placebo|Placebo
15882939|NCT03782246|Behavioral|MBCT|Mindfulness- based Cognitive Therapy
15882940|NCT03782246|Behavioral|CBT|Cognitive Behavioral Therapy
15882941|NCT03782233|Drug|A continuous intravenous infusion of 0.5-0.6 mg/kg/h Rocuronium Bromide Intravenous Solution (50 Mg/5 mL) to keep the target neuromuscular blockade (PTC = 1-2).|50 patients undergoing laparoscopic gastrectomy surgery will be allocated to group D. A continuous intravenous infusion of 0.5-0.6 mg/kg/h rocuronium to keep the target neuromuscular blockade (PTC = 1-2).
15882942|NCT03782233|Drug|A continuous intravenous infusion of 0.2-0.3 mg/kg/h Rocuronium Bromide Intravenous Solution (50 Mg/5 mL) to keep the target neuromuscular blockade (TOF = 1-2).|33 patients undergoing laparoscopic gastrectomy surgery will be allocated to group M. A continuous intravenous infusion of 0.2-0.3 mg/kg/h rocuronium to keep the target neuromuscular blockade (TOF = 1-2).
15882943|NCT03782220|Other|Kinesio tape|The Kinesio taping ( Kinesio Tex Gold, 2in x103.3 ft) was applied to sternocleidomastoid, upper trapezium and levator scapulae muscles by the muscle inhibition technique ( from insertion to origin of a muscle) for experimental group.
15882944|NCT03782220|Other|Shame tape|For the Shame taping group, a placebo taping method considered to be ineffective ( not from insertion to origin of muscles) with the same material without tension and with the neck in neutral position was used.
15882945|NCT03782207|Drug|Atezolizumab|Atezolizumab will be administered at the discretion of the treating physician per local guidelines and independently of participation in this study.
15882946|NCT03782194|Device|Low Intensity Focused Ultrasound Pulsation|A low intensity, focused ultrasound pulsation causes mechanical changed without causing heating or cavitation.
15882947|NCT03782194|Device|Sham Ultrasound|Low Intensity Focused Ultrasound Pulsation Transducer is left in place on the participant's head but is not turned on during the sham procedure.
15882948|NCT03782181|Device|Whole body vibration platform|A neuromuscular treatment using a rotational whole body vibration platform.
15882949|NCT03782155|Drug|glutamine supplementation|powder 14g
15882950|NCT03782155|Drug|HMB|powder 3g
15882951|NCT03782155|Drug|Placebo|powder 17g
15882952|NCT03782142|Drug|Tenofovir|TAF (tenofovir alafenamide) or TDF(tenofovir disoproxil fumarate)
15882953|NCT03782142|Drug|Rilpivirine|NNRTI
15882954|NCT03782142|Drug|Prezcobix|PI
15882955|NCT03782142|Drug|Dolutegravir|II
15882956|NCT03782129|Biological|blood samples|Blood samples drawn during hospitalisations when needed
15882957|NCT03782129|Other|Clinical exam and DFU medical cares|Clinical exam and DFU's medical cares at each visit (planned evry 1 to 3 months), during all the 5 years follow up, or until death.
15882958|NCT03782103|Drug|ZuraGard Clear Solution|Apply topically.
15882959|NCT03782103|Drug|ChloraPrep|Apply topically.
15882960|NCT03782103|Drug|Zurex Prep Vehicle|Apply topically.
15882993|NCT03781830|Other|mHealth Intervention|The video DOT app will allow transplant recipients to see their medication regimen, record themselves taking every dose, report side effects or symptoms, visualize their treatment progress, access educational content, and track appointments. This information is encrypted and transmitted to a HIPAA-secure web portal for providers to review.
15882994|NCT03781817|Drug|Intravenous Ketamine|Subject randomized to IV Ketamine arm will receive IN Normal Saline at induction. After 8 minutes subjects will receive IV Ketamine (10 mg/mL) at a dose of 1.5 mg/kg. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.
15883450|NCT03778294|Procedure|Positron Emission Tomography|Undergo PET/CT or PET/MRI
15882961|NCT03782090|Device|Endobronchial intubation|"In control group, endobronchial intubation is performed using conventional technique with left-sided double-lumen endobronchial tube(Shiley®). The tube is introduced into the glottis via direct laryngoscopy. After the tube tip passes the vocal cord, the tube is rotated 90º toward the left. The tube is advanced according to the depth(cm) of the tube calculated by the height of patient(12.5+0.1*height). Afterwards, the depth of the tube is adjusted by the compliance of both lung.
~In experimental group, patients are intubated with novel double-lumen endobronchial tube(Ankor®). The tube is introduced into the glottis via direct laryngoscopy. After the tube tip passes the vocal cord, the tube is rotated 90º toward the left. Once the carinal cuff of the tube is passed through the vocal cord of patients, the carinal cuff is inflated with 5-8ml of air. The tube is advanced until the tube stops itself at some point along the tracheobronchial tree. And then the carinal cuff is deflated."
15882962|NCT03782077|Procedure|Deflation of pneumatic tourniquet|Deflation of pneumatic tourniquet
15882963|NCT03782064|Drug|Nivolumab|Nivolumab is a monoclonal antibody. Antibodies are part of your immune system; they are a type of protein that protects your body against foreign invaders, called antigens, by grabbing hold of antigens to stop them from invading your system. Nivolumab has been shown to react against cancer cells, including MM cells.
15882964|NCT03782064|Biological|DC/myeloma fusions/GM-CSF|The DC/MM vaccine is an investigational agent that tries to help the immune system recognize and fight against cancer cells, utilizing unique markers.
15882965|NCT03782051|Procedure|combined phacoemulsification and viscocanalostomy|phacoemulsification with viscocanalostomy
15882966|NCT03782051|Procedure|combined phacoemulsification and viscocanalostomy and ologen|phacoemulsification with viscocanalostomy with ologen
15882967|NCT03782038|Device|MCD|Micro coring skin removal with automated coring device
15882968|NCT03782025|Drug|Phytomenadione|Blood samples will be taken before and after intravenously prescribed phytomenadione is given. Phytomenadione will be given independently of this study.
15882969|NCT03782012|Behavioral|Supported|Visual organization of knowledge base items plus discourse-based discussion supporting knowledge availability and accessibility
15882970|NCT03781999|Dietary Supplement|Actiful|supplement containing 500 mg orange extract and 200 mg pomegranate actives
15882971|NCT03781999|Other|Placebo|Maltodextrin
15882974|NCT03781973|Behavioral|Data platform +Quality Performance feedback reports|Teams from each of the participating sites will attend the webinars. Each site will share an example of a QI initiative that they are executing and describe the success and challenges.
15882975|NCT03781960|Drug|Abemaciclib|Abemaciclib will be given at a dose of 150mg by mouth twice daily continuously for the duration of trial therapy.
15882976|NCT03781960|Drug|Nivolumab|Nivolumab will be administered at a dose of 480mg IV every 28 days. Treatment with nivolumab will begin after an initial 7-day treatment period with abemaciclib monotherapy.
15882977|NCT03781947|Drug|teverelix TFA|A single s.c. or i.m. injection of teverelix TFA administered on Day 1
15882978|NCT03781934|Drug|MIV-818 + Pembrolizumab|MIV-818 - Oral Capsules Pembrolizumab - IV
15882979|NCT03781934|Drug|MIV-818 + Lenvatinib|MIV-818 - Oral Capsules Lenvatinib - Oral Capsules
15882980|NCT03781921|Other|No intervention|There is no intervention. Each group will conduct the same tasks and questionnaires and we will compare performances between groups.
15882981|NCT03781908|Drug|Silver Nitrate|First, pleural fluid drainage will be done after administration of 5 cc of local anesthetic lidocain1% either by insertion of chest tube (26F or 28F ) or by using ultrasonography. Pleural fluid drainage will be terminated when the patient want to cough to make sure that the pleural cavity is empty, then the sclerosant material will be injected, patients will receive 0.5% silver nitrate diluted in 50 ml distilled water with 10 ml of local anaesthetic lidocaine 1%.
15882982|NCT03781908|Device|Indwelling Pleural Catheter|"First , insert the wire into the pleural effusion at approximately the anterior axillary line. A 1-2 cm incision is made over the wire. A chest wall tunnel (5-8 cm in length) is created with a counter incision. The catheter is pulled through the tunnel and out next to the wire. After dilation of the wire tract with a Teflon peel-away sheath, the indwelling catheter is inserted into the chest. The counter incision is closed primarily, and the catheter is secured to the skin medially with a suture."
15882983|NCT03781895|Drug|Cholecalciferol|"• Cholecalciferol (40,000IU),
~,Microcrystalline Cellulose (58.1 gm), Butylated Hydroxy Toluene ( 0.2mg),Magnesium Stearate (3mg),Gelatin Capsule Shell (1mg)"
15882984|NCT03781882|Procedure|Platelet rich plasma infiltration in the wound edges|platelet rich plasma will be injected in the wound edges
15882985|NCT03781882|Procedure|Closure of wound without platelet rich plasma infiltration|No infiltration of platelet rich plasma is done
15882986|NCT03781869|Drug|Anlotinib Hydrochloride; etoposide and cisplatin|etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1 and Anlotinib Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle, repeated every 21 days
15882987|NCT03781869|Drug|etoposide and cisplatin|etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1, repeated every 21 days
15882988|NCT03781856|Behavioral|La Vida Buena Program|The intervention is series of interactive one hour weekly classes over the course of 8 weeks related to child healthy weight, exercise and nutrition. Facilitated by community health workers, the classes are interactive and play-based and designed to engage both the child and accompanying parent or guardian in activities.
15882989|NCT03781856|Behavioral|Brief Educational Session|A one hour session about nutrition and physical activity to address obesity facilitated by a community health worker
15882990|NCT03781843|Drug|Genicular nerve block with lidocaine|The color doppler ultrasound-guided genicular nerve block at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves.
15882991|NCT03781843|Drug|Genicular nerve block with saline|The color doppler ultrasound-guided genicular nerve block at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves.
15882992|NCT03781843|Drug|Genicular nerve block with dextrose|The color doppler ultrasound-guided genicular nerve block at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves.
15883140|NCT03780777|Behavioral|Home Hazard Removal|Removal of home barriers or hazards
15882995|NCT03781817|Drug|Intranasal Ketamine|Subject randomized to IN Ketamine arm will receive IN Ketamine (100 mg/mL) at a dose of 9 mg/kg at induction. After 8 minutes subjects will receive IV Normal Saline. Level of sedation will be scored at the 15 minutes from induction to determine if adequate sedation has been achieved.
15882996|NCT03781804|Drug|OPN-375|OPN-375, BID
15882997|NCT03781791|Drug|Active Investigational Treatment ENT-01|ENT-01 will be administered in tablet form, once daily.
15882998|NCT03781791|Drug|Placebo Treatment|Placebo will be administered in tablet form, once daily.
15882999|NCT03781778|Other|Dietary Intervention (resistant starch)|Eat foods with resistant starch
15883000|NCT03781778|Other|Dietary Intervention (regular starch)|Eat foods with regular corn starch
15883001|NCT03781778|Other|Questionnaire Administration|Ancillary studies
15883002|NCT03781765|Drug|Methylphenidate|stimulant medication
15883003|NCT03781765|Drug|Atomoxetine|non-stimulant medication
15883004|NCT03781752|Drug|Methylphenidate|study to determine dose
15883005|NCT03781739|Drug|MANP|single subcutaneous injection of MANP and monitoring of metabolic, cardiovascular and renal parameters
15883006|NCT03781726|Drug|glecaprevir/pibrentasvir treatment|combination treatment with glecaprevir and pibrentasvir fixed dose tablet.
15883007|NCT03781713|Other|KDIGO|Interventions to prevent renal replacement therapy
15883008|NCT03781713|Other|Delta SOFA|interventions to improve SOFA score
15883009|NCT03781713|Combination Product|Hypoglycemia|Interventions to prevent new episodes of hypoglycemia in the next 24 hours
15883010|NCT03781713|Drug|Drug interaction risk D or X|Intervention in the therapeutic plan in order to avoid adverse drug reactions.
15883011|NCT03781713|Drug|Antimicrobial stewardship|Optimization of anticrobial therapy based on Gram stain, MALDI TOF, MIC and antimicrobial susceptibility
15883012|NCT03781700|Drug|Prednisolone|Prednisolone 5 milligram tablets, 1 milligram per kilogram bodyweight per orally per day during 10 days, maximum 50 milligram per day.
15883013|NCT03781700|Drug|Placebo Oral Tablet|Placebo tablets with identical appearance to the experimental drug
15883014|NCT03781687|Procedure|Bilateral ESP Block|Bilateral ESP Block will be performed at T8
15883015|NCT03781687|Procedure|Unilateral ESP Block|Unilateral ESP Block will be performed at T8 (right side)
15883016|NCT03781687|Device|Intravenous Morphine patient controlled analgesia device|24 hour morphine consumption will be recorded
15883017|NCT03781674|Drug|progesterone 400mg|Women received vaginal progesterone suppositories in a dose of 400 mg daily beginning at 18-22 weeks gestational age
15883018|NCT03781674|Drug|progesterone 200mg|Women received vaginal progesterone suppositories in a dose of 200 mg daily beginning at 18-22 weeks gestational age
15883019|NCT03781674|Drug|placebo to progesterone 200mg|Women received placebo to vaginal progesterone 200 mg suppositories in a dose of (2 tablets) daily beginning at 18-22 weeks gestational age
15883020|NCT03781674|Drug|placebo to progesterone 400mg|Women received placebo to vaginal progesterone 400 mg suppositories in a dose of (4 tablets) daily beginning at 18-22 weeks gestational age
15883021|NCT03781661|Other|Extended information|The extended information consists out of an information leaflet and a visual go-through of the participants calcium score images. The patients are then given the normal examination result.
15883022|NCT03781648|Diagnostic Test|NBI withdrawal method|The newly available second generation of NBI using the 290 system (290-NBI) provides an at least twofold brighter image compared with the previous version
15883023|NCT03781635|Drug|bolus of intravenous ketamine|low-dose ketamine (0.25mg.kg-1) is administered intraoperatively as bolus at incision (T0) and for each hour of anesthesia untel the end of surgery.
15883024|NCT03781635|Drug|continuous infusion of intravenous ketamine|An infusion of low-dose ketamine (0.25 mg.kg-1.h-1) is started at T0 (incision) with an infusion pump and is kept at the same rate until the end of surgery
15883025|NCT03781622|Device|WOLF Thrombectomy Device|Mechanical thrombectomy for the neurovasculature
15883026|NCT03781609|Behavioral|Roller system group (RG)|They will first receive the standard of care that is often used in rehabilitation: a 30 minute educational session about recommended propulsion techniques with no motor learning principles implemented. In addition, they will execute 750-1250 wheelchair propulsion repetitions on the roller system per each 1 hour session (2-3 x per week for 4-6 weeks) until they reach approximately 10,000 repetitions (10 sessions). Each session will focus on minimizing the force and frequency of pushes while using longer push strokes during propulsion.
15883027|NCT03781609|Behavioral|Overground group (OG)|They will first receive the standard of care that is often used in rehabilitation: a 30 minute educational session about recommended propulsion techniques with no motor learning principles implemented. In addition, they will execute 750-1250 wheelchair propulsion repetitions overground per each 1 hour session (2-3 x per week for 4-6 weeks) until they reach approximately 10,000 repetitions (10 sessions). Each session will focus on minimizing the force and frequency of pushes while using longer push strokes during propulsion.
15883028|NCT03781609|Behavioral|Placebo - Wheelchair skills group (WSG)|They will receive the standard of care that is often used in rehabilitation: a 30 minute educational session about recommended propulsion techniques with no motor learning principles implemented.
15883029|NCT03781596|Diagnostic Test|Retrospective evaluation of endoscopy prior to study drug|Once enrolled, the patient's original endoscopy will be evaluated including the images from the EGD and the biopsies for eotaxin 3 staining and eosinophilic burden.
15883030|NCT03781596|Other|Symptom Survey|Patient will complete symptom survey prior to starting the study drugs.
15883031|NCT03781596|Other|Medication Compliance Phone Call|The patient will receive a phone call at 4 weeks to evaluate medication compliance including the number on the inhaler and the number of pills remaining in the container.
15883032|NCT03781596|Diagnostic Test|Endoscopy while on study drug|Endoscopy will be performed after 8 weeks of therapy. Endoscopic scoring will be assigned and the histology will be evaluated, including eotaxin 3 staining. The change in eosinophil count and eotaxin staining will be measured.
15883033|NCT03781596|Other|Symptom Survey|The patient will complete a symptom survey after 8 weeks on the study drugs, and the change in survey score will be measured.
15883034|NCT03781596|Drug|Fluticasone|Participants in the experimental and placebo arms will be given swallowed fluticasone for an 8 week course. Doses determined by age and weight.
15883035|NCT03781596|Drug|Omeprazole|The participants in the experimental arm will be given oral omprazole capsules for an 8 week period (along with the swallowed fluticasone). Doses determined by age and weight.
15883036|NCT03781596|Drug|Placebo oral capsule|The participants in the placebo arm will be given placebo capsules for an 8 week period (along with the swallowed fluticasone). Number of pills determined by age and weight (to match omeprazole dosing).
15883037|NCT03781583|Device|No HMD used|Participants will use their existing mobility skills and strategies to navigate toward a goal. If the participant cannot perform this task, the participant will not be forced to.
15883038|NCT03781583|Device|HMD worn but not active|Participants will wear the HMD, but the HMD will not be active. This will test whether or not the HMD physical components obscure the participants remaining vision and reduce the participants ability to navigate toward a goal.
15883039|NCT03781583|Device|HMD worn and active|Participants will wear the HMD and the HMD will be active. This will test the HMD function for navigation toward a goal.
15883040|NCT03781557|Dietary Supplement|Docosahexaenoic acid|High-concentrated DHA
15883041|NCT03781557|Dietary Supplement|Eicosapentaenoic acid|High-concentrated EPA
15883042|NCT03781557|Dietary Supplement|Olive oil|Olive Oil softgels
15883043|NCT03781544|Drug|Tramadol|A single i.v. infusion of Tramadol (dose: 400mg/100ml) will be administered to the participants (treatment arm).
15883044|NCT03781544|Drug|Paracetamol|A single i.v. infusion of Paracetamol (dose: 1g/100ml) will be administered to the participants (control arm).
15883045|NCT03781544|Drug|Diclofenac|A single i.v. infusion of Diclofenac (dose: 75mg/100ml) will be administered to the participants (treatment arm).
15883046|NCT03781518|Procedure|ridge splitting in group and khoury shell technique in the other group|Mandibular ridge splitting with complete separation of the buccal cortical plate for horizontal augmentation of atrophic posterior mandible in one group and the other group will receive khoury shell technique by taking bone block from the ramus
15883047|NCT03781505|Drug|Paracetamol +caudal ropivacaine|Paracetamol + Ropivacaine
15883048|NCT03781479|Drug|Amifampridine Phosphate|Amifampridine phosphate tablets 10 mg will be provided in round, white-scored tablets, and containing amifampridine phosphate formulated to be the equivalent of 10 mg amifampridine base per tablet.
15883049|NCT03781479|Drug|Placebo Oral Tablet|Placebo Oral Tablet
15883050|NCT03781466|Procedure|Cervical cerclage|Cervical cerclage indicated by short cervix ≤25mm
15883051|NCT03781466|Drug|vaginal progesterone|Daily vaginal progesterone 400mg from diagnosis of short cervix to 36 weeks
15883052|NCT03781453|Behavioral|POWERPLAY|"Employees from participating worksites will be invited to completed surveys prior to and following implementation of a workplace wellness program (called POWERPLAY)"
15883053|NCT03781440|Procedure|Bilateral ESP catheter with lidocaine|All participants will get the Erector Spinae Plane (ESP) catheters. Prior to transfer to the operating room, participants will receive bilateral ESP catheters at T7 level under ultrasound guidance. This arm is the treatment group and will receive lidocaine via alternating side automated infusion pump bolus dosing, continued until chest tube removal or postoperative day 5 (whichever occurs earliest).
15883054|NCT03781440|Procedure|Bilateral ESP catheter with saline|All participants will get the Erector Spinae Plane (ESP) catheters. This arm is the control group and will have normal saline administered via ESP catheters, continued until chest tube removal or postoperative day 5 (whichever occurs earliest).
15883055|NCT03781427|Device|Cardiac resynchronization therapy|Left ventricular pacing
15883056|NCT03781414|Biological|CFZ533|Comparison with standard of care immunosuppression
15883057|NCT03781414|Drug|Tacrolimus - MMF - corticosteroids|Standard of care immunosupprevive regimen
15883059|NCT03781388|Drug|Bupivacaine|Determination of the dose will rely on the outcomes of the preceding 7 patients receiving the same dose, as the number of previous patients to consider is a function of the target dose. Among all patients who received a certain dose, a proportion of successful outcomes will be determined (P(d)); if P(d) <0.90, and at least one of the previous 7 patients who received the same dose had an unsatisfactory outcome, the next patient will receive a pre-determined increment of 0.75 mg of bupivacaine. Alternatively, if P(d) 0.90 and the previous 7 patients who received the same dose had successful outcomes, the next patient will receive a pre-determined decrement of 0.75mg of bupivacaine. Otherwise, the dose will remain the same.
15883060|NCT03781375|Drug|Etanercept|Administered by subcutaneous injection twice a week
15883061|NCT03781375|Drug|Placebo to Etanerceot|Administered by subcutaneous injection twice a week
15883062|NCT03781375|Drug|Methotrexate|Administered orally or subcutaneously once a week at the same dose as prior to study entry
15883063|NCT03781362|Drug|CPI-100|CPI-100 will be administered via intravenous infusion on Day 1 of a 14-Day cycle
15883064|NCT03781362|Drug|Capecitabine|Capecitabine will be administered 1000 mg/m2 orally twice a day for 2 weeks followed by a 7-day rest period
15883065|NCT03781349|Device|MENS|
15883066|NCT03781349|Device|TENS|
15883067|NCT03781336|Behavioral|Mindfulness-based self care|Experimental: an abridged mindfulness-based program that is incorporated into the work day, which consists of five weekly 1.5 hour sessions.
15883068|NCT03781323|Drug|FOLFOX|"Patients treated on protocol will be treated with modified FOLFOX. Patients will receive 10 cycles of FOLFOX, administered every other week. FOLFOX will be given on day 1 of each cycle.
~Patients will receive oxaliplatin 85 mg/m² IV over 120 minutes, leucovorin 400 mg/m² IV over 120 minutes, 5-FU 400 mg/m² IVP followed by 5-FU 2400 mg/m² infuse over 46 hours."
15883069|NCT03781310|Drug|Tocilizumab|IV Tocilizumab once every 4 weeks at reduced dose according to algorithm.
15883219|NCT03780101|Diagnostic Test|Multi-parametric renal MRI|Multi-parametric functional magnetic resonance imaging of a transplant kidney including sequences for T1, T2, diffusion-weighted imaging, diffusion tensor imaging and arterial spin labelling.
15883220|NCT03780088|Behavioral|mTranS-C|mobile health
15883072|NCT03781284|Diagnostic Test|[18F]-FDG PET/MRI|
15883073|NCT03781284|Diagnostic Test|Colonoscopy|
15883074|NCT03781271|Device|Electromagnetic Navigation|Electromagnetic navigation is a form of surgical navigation that can be incorporated into the cervical interstitial brachytherapy workflow to improve the current standards of guidance.
15883075|NCT03781258|Drug|Warfarin|Anti-thrombotic monotherapy (ASA)-Warfarin withdrawal.
15883076|NCT03781245|Other|All the Right Moves for Subcontractors|"All the Right Moves for Subcontractors aims to improve safety, health and wellbeing, through the development of a communication infrastructure with supplemental tools where construction workers and company mangers work together to collaboratively identify problems and strategies to improve their conditions of work. The intervention is grounded in the key characteristics of integrated organizational interventions to improve workers' health safety and wellbeing detailed in Harvard Center for Work, Health and Wellbeing's Implementation Guidelines (McLellan et al, 2016).
~The intervention involves a cyclical approach through which the research team facilitate a participatory process to identify workers' health concerns, prioritize these concerns, use an action planning process to identify and operationalize solutions, and develop a company-specific evaluation plan to measure change."
15883077|NCT03781232|Device|Prototype 0.3|Prototype 0.3 is a non-invasive glucose monitoring device using Raman spectroscopy
15883078|NCT03781219|Drug|HL-085|HL-085 ( Capsule) is one MEK inhibitor.
15883079|NCT03781219|Drug|Vemurafenib|Vemurafenib ( Tablet) is BRAF inhibitor,
15883080|NCT03781206|Device|PICO™ 7|PICO™ system (Smith&Nephew Healthcare, Hull, UK) is a Single-Use Negative Pressure Wound Therapy (NPWT) System consisting of a small portable pump, 2 lithium batteries, 2 dressings and fixation strips.
15883081|NCT03781193|Other|Questionnaires administration|Psychological and quality of life questionnaires
15883082|NCT03781193|Other|Five Facet Mindfulness Questionnaire (FFMQ)|FFMQ is a 39-item measure consisting of five subscales (observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience).
15883083|NCT03781193|Other|Langer Mindfulness Scale (LMS)|The LMS Tis a 21-item questionnaire, assessing four domains associated with mindful thinking: novelty-seeking, engagement, novelty producing, and flexibility.
15883084|NCT03781193|Other|Cognitive Flexibility Scale (CFS)|The CFS is 12-item self-report test assessing awareness.
15883085|NCT03781193|Other|Life Orientation Test (LOT)|The LOT is a 10-item, self-administered scale assessing generalized expectancies for positive versus negative outcomes.
15883086|NCT03781193|Other|Mini Locus of Control test (MLS)|The MLS is a 6-item questionnaire that includes 3 factors : chance, powerful others, and internality.
15883087|NCT03781193|Other|Hospital Anxiety and Depression Scale (HADS)|The HADS is a 14-items rated on a four-point Likert scale. The questionnaire was designed to screen for the presence and severity of depression (HADS-D) and anxiety (HADS-A) in people with a physical symptomatology
15883088|NCT03781193|Other|Perceived Stress Scale (PSS)|The PSS is 14-item self-report tool commonly used to provide a global measure of perceived stress in daily life.
15883089|NCT03781193|Other|Toronto Alexithymia Scale (TAS)|The TSA is a 20-item scale that evaluates the three components of alexithymia: difficulty to identify feelings and distinguish between feelings and bodily sensations of emotional arousal difficulty, describing feelings to others, and a cognitive style that is literal, utilitarian, and externally oriented.
15883090|NCT03781167|Drug|ABBV-951|solution for infusion
15883091|NCT03781154|Behavioral|Group Exercise|Patients will exercise in a virtual group for 60 minutes, twice a week. Five social-cognitive theory-based discussion sessions with the group, and group exercise instructor will be held throughout the course of the intervention, lasting 30 to 60 minutes. The goal of these sessions is to enhance long-term physical activity behavior change.
15883092|NCT03781141|Procedure|Wound closure|Comparison of two wound closures
15883093|NCT03781128|Drug|Lysergic Acid Diethylamide|100 µg, per os, 3 times within 3 weeks
15883094|NCT03781128|Drug|Placebo|placebo in an identical-looking vial as LSD, per os, 3 times within 3 weeks
15883095|NCT03781115|Drug|Ziprasidone|anti-psychotic drug proposed for use as rapid diagnostic tool
15883096|NCT03781115|Drug|Olanzapine|anti-psychotic drug proposed for use as rapid diagnostic tool
15883097|NCT03781115|Drug|Placebo Comparator|A non drug oral placebo capsule will be given as a control
15883098|NCT03781102|Behavioral|16-Week Diabetes Prevention Program for Mothers and Children|The 16-week intervention is focused on ways to modify behaviors associated with the pathogenesis of Type 2 Diabetes in youth, while engaging participants in fun, active, and interactive food demonstrations, energy balance, and physical activities appropriate for all the family. Weekly sessions will consist of: (1) physical activity upon arrival; (2) small group discussions; (3) hands-on food preparation and tasting opportunities; (4) low- to no-cost fun family physical activities; (5) energy balance activities (e.g. label reading) to increase foundational knowledge; and, (6) opportunities to set new weekly goals.
15883099|NCT03781089|Drug|Patiromer Oral Powder Product|Patients randomized to the patiromer arm will initiate on 8.4 g/day (one pack) given once a day with breakfast or lunch (in place of the full dose of phosphate binder), to start at the end of Week 0. The patiromer dose will be titrated based on serum potassium concentrations drawn on HD1 of Weeks 1, 2, and 3. Patiromer will be increased by 8.4 g/day if K ≥ 5.1 meq/L, decreased by 8.4 g/day if K < 4.0 mEq/L, and patiromer will be discontinued if K < 3.5 mEq/L. Patients randomized to the usual care arm will undergo monitoring with laboratory measurements as outlined in the study protocol
15883141|NCT03780764|Other|"A Pre-adjusted edgewise brackets: 3M Gemini Unitek, 0.022 Roth prescription brackets"|"A pre-adjusted edgewise fixed appliance (3M Gemini Unitek, 0.022 Roth prescription brackets) on one side of lower arch. The standardized bonding technique was applied according to the manufacturer's instructions. Teeth alignment was initiated using round 0.016 NiTi arch wire until 0.016X0.022 NiTi was reached. The NiTi arch wires were placed into brackets slots and tied with elastomers (figure of 8)."
15883100|NCT03781076|Behavioral|Sleep Intervention|The study therapist will outline the biopsychosocial model of mTBI recovery, highlighting the shift from biological injury to behavior (especially sleep behavior) as key driver of symptoms. The intervention will then apply well-established strategies from the pediatric psychology and insomnia literatures, encouraging conjoint problem-solving by parent and youth with the shared goal of maximizing nocturnal sleep. These include: pre-planning, problem-solving, development of a positive routine, commitment to sleep-promoting behaviors, self-monitoring, and positive reinforcement. The therapist will also teach a brief, self-guided pre-sleep relaxation exercise that has been used in insomnia treatment to maximize the benefit of additional sleep opportunity.
15883101|NCT03781063|Drug|Lasofoxifene|Estrogen receptor antagonist antineoplastic agent
15883102|NCT03781063|Drug|Fulvestrant|Estrogen receptor antagonist antineoplastic agent
15883103|NCT03781050|Drug|Rapamycin|"For children: rapamycin, 1 mg per square meter of body surface area a day, orally, for at least 6 months
~For adults: rapamycin, 2 mg a day, orally, for at least 6 months"
15883104|NCT03781037|Behavioral|GIVE Module|The GIVE Module is a brief cognitive behavioral intervention targeting youths' beliefs that they are a burden or drain on others. It consists of two sessions embedded within a larger CBT protocol for anxiety or depression.
15883105|NCT03781024|Combination Product|Footwash|footbath/footwash can help cleanse the wound, remove dead tissue, increase circulation and puts the wound in direct contact with medication to promote faster healing.
15883106|NCT03781011|Behavioral|Low carnitine/choline diet habit|Patients will received dietary education and supervision by dietician to avoid high carnitine/choline foods including red meat, eggs...etc.
15883107|NCT03780998|Drug|Life7|Life7 will used on the perianal skin with finger tips
15883108|NCT03780985|Procedure|Intrauterine device insertion|Post-placental insertion of intrauterine device during Cesarean section
15883109|NCT03780985|Procedure|Cesarean section|to delivery of the fetus
15883110|NCT03780985|Procedure|Suture|to fix the intrauterine device
15883111|NCT03780972|Drug|ONL1204|Administration of ONL1204 - inhibitor of Fas(CD95) signaling by intravitreal injection
15883112|NCT03780972|Procedure|Intravitreal Injection|Injection of study drug into the eye
15883113|NCT03780972|Procedure|Collection of ocular fluids|vitreous and aqueous fluid collection by a tap and during vitrectomy
15883114|NCT03780959|Drug|Etanercept|Administered twice weekly by subcutaneous injection
15883115|NCT03780959|Drug|Placebo|Administered twice weekly by subcutaneous injection
15883116|NCT03780946|Procedure|Magnetic anastomosis for pancreaticojejunostomy|Magnetic anastomosis for pancreaticojejunostomy
15883117|NCT03780946|Procedure|Traditional hand-sewn anastomosis|Traditional manual anastomosis for pancreaticojejunostomy
15883118|NCT03780933|Dietary Supplement|vitamin c|vitamin c IV 10 G
15883119|NCT03780920|Procedure|manual therapy/osteopathy|"In this group, children will benefit from early osteopathic treatment over a period ranging from the third day to 4 months. The number of sessions will not be fixed, on average, 3 sessions will be carried out during this period at the University Hospital of Montpellier.
~The duration of the session will be between 20 minutes to 30 or even 40 minutes"
15883120|NCT03780907|Drug|E2007|1 mg of E2007 was administered by mouth once daily.
15883121|NCT03780907|Drug|E2007|2 mg of E2007 was administered by mouth once daily.
15883122|NCT03780907|Drug|Placebo|Placebo once daily of oral tablet formulation to be taken in the morning, one hour before breakfast, with a glass of water.
15883123|NCT03780894|Drug|Fibrinogen Concentrate (Human) 1 MG [RiaSTAP]|Administration of 2 mg of FC together with RBC and TXA
15883124|NCT03780894|Biological|Red blood cells concentrate|Administration of 2 red blood cells concentrates together with FC and TXA
15883125|NCT03780894|Drug|Tranexamic Acid|Administration of 1g of TXA together with FC and RBC
15883126|NCT03780881|Behavioral|Expectation confirmation|Participants receive manipulated feedback indicating that their performance was above average in the test they had previously worked on. This feedback is intended to confirm the previously induced positive expectations of their own performance.
15883127|NCT03780881|Behavioral|Expectation disconfirmation|Participants receive manipulated feedback indicating that their performance was below average in the test they had previously worked on. This feedback is intended to negatively disconfirm the previously induced positive expectations of their own performance.
15883128|NCT03780868|Procedure|external dacryocystorhinostomy|external DCR under general anesthesia with standard sterilization procedures.
15883129|NCT03780868|Procedure|canalicular silicone intubation with MMC|canalicular silicone intubation with MMC under general anesthesia with standard sterilization procedures.
15883130|NCT03780855|Device|nerve scaffold|It is a new kind of nerve scaffold with the microstructure of longitudinally oriented microchannels. It's made of collagen as the main raw material.
15883131|NCT03780842|Device|NAVA level|"A titration protocol will be used for changing NAVA levels. The NAVA level will be reduced to 0,5 cmH2O/µV for 3 minutes as a starting point. Limit peak pressure will be set to 35cmH2O (i.e. according to the standard manufacturer's settings) the maximum pressure that can be delivered to the patient is cut off at 30cmH2O). Other ventilator settings will be left unchanged and are as clinically indicated. Ventilator settings will be according to our standard of care and as following: PEEP between 4 and 7 mmHg, apnea time 2-5 sec, back-up ventilation with a pressure above PEEP between 5 and 15 mmHg and a frequency between 30 and 50 per minute.
~Starting from a NAVA level of 0,5 cmH20/µV the level will be increased by 0,5 cmH2O/µV every 3 minutes until reaching a maximum NAVA level of 4,0 cmH2O/µV."
15883132|NCT03780829|Behavioral|hypoxia|intermittent cycles of normoxia-hypoxia
15883133|NCT03780829|Behavioral|sham hypoxia|intermittent cycles of sham hypoxia
15883134|NCT03780829|Drug|D-cycloserine|NMDA agonist treatment
15883135|NCT03780829|Drug|sham-NMDA agonist|sham-NMDA agonist treatment
15883136|NCT03780829|Behavioral|exercise training|bimanual massed practice training
15883137|NCT03780816|Other|Observation of provider-patient interactions and interviews|Clinical interactions between cancer patients and providers will be observed and hand-written field notes recorded and later transcribed. Semi-structured interviews with providers, patients, caregivers, and other informants will take place following initial observation.
15883138|NCT03780803|Other|home cardiac rehabilitation and respiratory rehabilitation|
15883139|NCT03780790|Drug|Bupivacaine|% 0,25
15883142|NCT03780764|Other|"Self- ligating brackets: Unitek™ Gemini SL Self-Ligating Brackets, 0.022 Roth prescription brackets"|"Self-ligating brackets (Unitek™ Gemini SL Self-Ligating Brackets, 0.022 Roth prescription brackets) on the other side of lower arch. The standardized bonding technique was applied according to the manufacturer's instructions. Teeth alignment was initiated using round 0.016 NiTi arch wire until 0.016X0.022 NiTi was reached. The NiTi arch wires were placed into brackets slots and held in place by bracket's gate in the self-ligating brackets side."
15883143|NCT03780751|Behavioral|Cognitive-behavioral treatment|COPE-program of 8 sessions (+ 1 booster session) of guided Internet-based treatment including psychoeducation, sexual education, guided masturbation, sensate focus and cognitive-behavioral interventions (e.g., thought diaries, challenging of maladaptive thought patterns, behavioral analysis). Participants are encouraged to practice exercises between sessions.
15883144|NCT03780751|Behavioral|Mindfulness-based treatment|MIND-program of 8 sessions (+ 1 booster session) of guided Internet-based treatment including psychoeducation, sexual education, guided masturbation, sensate focus and mindfulness-based exercises (e.g., breathing meditation, body scan, sitting meditation).
15883145|NCT03780725|Drug|BI 754111|Solution for infusion
15883146|NCT03780725|Drug|BI 754091|Solution for infusion
15883147|NCT03780712|Other|Non applicable|No intervention as it is an observational study
15883148|NCT03780699|Procedure|Diagnostic hysteroscopic examination|The hysteroscopic criteria of the cesarean scar defect will be observed with comment on different niche features
15883149|NCT03780686|Drug|Norepinephrine, dopamine|drugs to decrease bleeding
15883150|NCT03780673|Drug|Simvastatin|Simvastatin 20 mg/day for 12 months
15883151|NCT03780673|Drug|Rifaximin|Rifaximin 400/8 hours for 12 months
15883152|NCT03780673|Drug|Placebo of Simvastatin|Placebo of Simvastatin once a day for 12 months
15883153|NCT03780673|Drug|Placebo of Rifaximin|Placebo of Rifaximin/8 hours for 12 months
15883154|NCT03780647|Other|questionnaire|Assessment of the impairment at work by a specific auto- questionnaire given after echo-Doppler that confirm the diagnosis
15883155|NCT03780634|Procedure|HAIC|administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries every 3 weeks
15883156|NCT03780634|Drug|PD-1 antibody|200mg intravenously every 3 weeks
15883157|NCT03780634|Drug|Sorafenib|400 mg Bid Po
15883158|NCT03780621|Dietary Supplement|Andrographis and Withania|Combination of Andrographis paniculata and Withania somnifera
15883159|NCT03780621|Dietary Supplement|Placebo|Visually identical placebo capsule
15883160|NCT03780608|Drug|AZD6738|AZD6738 will be administered at 240 mg twice daily on days 1 to 7 in Cycle 0 (lead-in period) and therafter at 240 mg BD on days 22 to 28 in a 28-day cycle.
15883161|NCT03780608|Drug|Durvalumab|. Durvalumab will be administered at 1500 mg every 4 weeks from cycle 1 day 1.
15883162|NCT03780595|Drug|Passiflora incarnata|Passiflora pills administration up to 6 pills per day
15883163|NCT03780595|Drug|Control|Control pills administration up to 6 pills per day
15883164|NCT03780582|Behavioral|AI-human interaction|Exploring what kinds of AI-human interaction improve radiologists detection accuracy.
15883165|NCT03780569|Device|NovoTTF-200A|Patients receive continuous TTFields treatment using the NovoTTF-200A device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the scalp. The treatment enables the patient to maintain regular daily routine.
15883166|NCT03780569|Radiation|Radiotherapy|60Gy given in 30 2Gy fractions concomitant to temozolomide
15883167|NCT03780569|Drug|Temozolomide|"Temozolomide(TMZ) will be administered at 75 mg/m^2 concomitant to radiotherapy(RT) and NovoTTF-200A.
~Maintenance treatment is to begin about 4 weeks after the end of TMZ/RT/NovoTTF-200A. TMZ is administered at the conventional dosing regimen for 5 days, every 28 days (i.e. 5 days of therapy, 23 days of rest). Cycle 1 is to be given at a dose of 150 mg/m^2 p.o. daily x 5 days, dose to be escalated to 200 mg/m^2 in the absence of toxicity."
15883168|NCT03780556|Drug|Lornoxicam and mepridine|compare the effect of each to control pain
15883169|NCT03780543|Drug|ABI-H0731|Participants will receive 300 mg QD of ABI-H0731 tablets orally.
15883170|NCT03780543|Drug|SOC NrtI|Participants will continue on their SOC NrtI (ETV, TDF or TAF) tablet QD orally as per approved package insert.
15883171|NCT03780530|Procedure|subcuticular suturing|Those undergoing Subcuticular suturing of perineal skin using 910 polyglactin vicryl No 2/0 (EGYCRYL®).
15883172|NCT03780530|Procedure|Surgical glue|Those undergoing perineal skin closure using adhesive glue n-butyl-2-cyanoacrylate (Histoacryl®).
15883173|NCT03780530|Procedure|adhesive steri-strip tape|Those undergoing closure of perineal skin via Adhesive surgical water-resistant tape application. (3M® Transpore™ Surgical Tapes).
15883174|NCT03780517|Drug|BOS172738|Oral capsules
15883175|NCT03780491|Other|Cost Discussion|The second group of 50 patients will be the intervention group where the providers will have a discussion of cost emphasizing five points: 1) Cancer care is expensive and it is normal to be concerned about cost. 2) We will recommend treatments for your cancer based on what we think gives you the best chance of doing well, not based on the cost of the treatment. 3) Because of how complex our healthcare system is, it is very hard for your doctors to know what your costs will be, but we will do our best to give you some general information. 4) We have resources available to help you get more specific information so that you can plan appropriately. 5) Do you have any specific concerns about cost that you'd like to share with me?
15883176|NCT03780478|Drug|Nerve block|0.25% bupivacaine with epinephrine (1:100k), with total volume of 2mL
15883177|NCT03780478|Drug|Placebo Saline Injection|Saline injection, total volume 2ml
15883178|NCT03780465|Drug|Oral idronoxil suspension|Idronoxil powder up to 150 ml ORA-BLEND® flavoured syrup
15883179|NCT03780465|Drug|NOX66 (A)|Idronoxil formulated in suppository base A
15883180|NCT03780465|Drug|NOX66 (B)|Idronoxil formulated in suppository base B
15883181|NCT03780452|Device|novel dynamic compression intramedullary nail|Tibiotalocalcaneal (TTC) arthrodesis with a novel dynamic compression intramedullary nail. The assignment of the device is at the discretion of the standard of care provider, not the study investigator.
15883218|NCT03780127|Drug|Fenfluramine Hydrochloride|ZX008 drug product is an oral aqueous solution of fenfluramine hydrochloride. The product is sugar free and is intended to be compatible with KD.
15883451|NCT03778294|Radiation|Proton Beam Radiation Therapy|Receive proton beam RT
15883182|NCT03780426|Device|tSMS|Transcranial static magnetic field stimulation (tSMS) is a non-invasive brain stimulation (NIBS) technique that decreases cortical excitability (Oliviero et al., 2011; Oliviero et al., 2015; Dileone et al., 2018). Static magnetic fields suitable for tSMS are obtained with commercially available neodymium magnets. We will use a cylindrical neodymium magnet of 45 mm diameter and 30 mm of thickness, with a weight of 360 g (MAG45r; Neurek SL, Toledo, Spain), which will be applied with south polarity to the left or right motor cortex, using a tSMS helmet (MAGmv1.0; Neurek SL, Toledo, Spain).
15883183|NCT03780426|Device|sham|A non-magnetic metal cylinder, with the same size, weight and appearance of the magnet, will be used for sham stimulation (MAG45s; Neurek SL, Toledo, Spain) of motor cortex contralateral to the stimulated hemisphere.
15883184|NCT03780413|Behavioral|PR-ESSENCE treatment|
15883185|NCT03780413|Behavioral|Control (TAU)|
15883186|NCT03780400|Behavioral|Osteoarthritis Physical Activity Care Pathway|The intervention includes brief physical activity (PA) counseling delivered via phone by a PA Counselor trained in relevant aspects of PA and motivational interviewing. During the initial call, the PA counselor will assess readiness for change in PA and will utilize appropriate PA counseling components to assess participant's PA preferences/needs, as well as referral to PA resources and goal setting. Approximately two weeks after the initial call, the PA counselor will contact participants to check in on whether they have successfully connected with PA programs or resources discussed, review progress toward PA goals and set new goals. Participants will be provided with linkage to PA programs and resources to include: self-directed, group classes/community, physical therapy and other clinical/supervised programs. Three months after the initial call, the PA counselor will call participants to assess PA and stage of change using appropriate PA counseling components and goal setting.
15883187|NCT03780387|Biological|Felis Catus|Inhalation of Felis Catus allergen in subjects allergic to Felis Catus
15883188|NCT03780374|Device|Phonak Audéo L2M with Sound Processing Principle 1|Compensation of a hearing loss with Sound Processing Principle 1.
15883189|NCT03780374|Device|Phonak Audéo L2M with Sound Processing Principle 2|Compensation of a hearing loss with Sound Processing Principle 2.
15883190|NCT03780374|Device|Phonak Audéo L2M with Sound Processing Principle 3|Compensation of a hearing loss with Sound Processing Principle 3.
15883191|NCT03780361|Drug|Aflibercept Injection|Total 5 times of monthly intravitreal aflibercept injections will be done.
15883192|NCT03780348|Diagnostic Test|New Method|A 'new' WHZ tool will be used to assess children.
15883193|NCT03780348|Diagnostic Test|Existing Method|'Existing' WHZ tools will be used to assess children
15883194|NCT03780335|Diagnostic Test|Computation of quantitative flow ratio|Computation of QFR was performed offline, using AngioPlus system(Pluse medical imaging technology, Shanghai, China). In the first step, 2 diagnostic angiographic projections before PCI, at least 25° apart, were selected and 3D reconstruction of the interrogated vessel without its side branches was performed. Then, the software computed the QFR.
15883195|NCT03780322|Device|Armeo Spring Pediatric|"Before intervention, the robotic device will be adjusted to the user's unique dimensions to avoid injury.
~Each 45 minute session will include active upper extremity shoulder abduction, shoulder external rotation and/or elbow extension exercises, led by virtual reality game and supported by robotic arm. Sessions will take place 3 times a week for a total of 15 sessions."
15883196|NCT03780322|Other|Conventional physical and occupational therapy|"Conventional therapy will combine physical and occupational therapy, including the following activities:
~Upper extremity weight bearing exercises.
~Approximation techniques on wrist, elbow and shoulder.
~Proprioceptive neuromuscular facilitation: shoulder flection, adduction and external rotation and shoulder flection, abduction and external rotation.
~Scapulothoracic joint mobilization.
~Stretching of shoulder abductors and external rotators.
~Hand/wrist facilitation exercises (with ball). This will be carried out in 45 minute sessions, 3 times a week, for a total of 15 sessions."
15883197|NCT03780309|Behavioral|Exercise Self-Monitoring|Participants engaged in exercise self-monitoring utilizing a traditional calendar recording method and heart rate monitor.
15883198|NCT03780309|Behavioral|Blood Pressure Self-Monitoring|Participants engaged in blood pressure self-monitoring by measuring blood pressure twice daily and before and after exercise.
15883199|NCT03780296|Device|Real-time action observation with augmented Kinect|Participants will receive 30 minutes of the augmented kinect software in real-time undergoing an exercise protocol involving seated upper extremity exercises, seated lower extremity exercises and standing upper extremity exercises.
15883200|NCT03780283|Drug|Anlotinib Hydrochloride|Participants receive Anlotinib 12mg, administered as PO on Day1-14 of each 21-day cycle until documented PD or had unacceptable toxicity
15883201|NCT03780270|Device|Fluoride Varnish|Fluor Protector S (Ivoclar, 7'700 ppm F-)
15883202|NCT03780270|Device|Curodont Repair|P11-4 (monomeric peptide) - for professional use
15883203|NCT03780270|Device|Curodont Protect|Tooth gel (containing P11-4 assembled to a fibrillary matrix) - for home use (OTC)
15883204|NCT03780257|Drug|QR-421a|RNA antisense oligonucleotide for intravitreal injection
15883205|NCT03780257|Other|Sham-procedure (dose cohort 1&2 only)|Sham-procedure (no experimental drug administered)
15883206|NCT03780244|Device|Sculptra Aesthetic 8ml|Treatment of nasolabial folds
15883207|NCT03780244|Device|Sculptra Aesthetic 5ml|Treatment of nasolabial folds
15883208|NCT03780231|Other|non-ischemic scar|"non-ischemic LGE with no underlying labelled cardiomyopathy is detected on CMR"
15883209|NCT03780218|Other|Respiratory function|Respiratory function test evaluates the participants' pulmonary function and respiratory muscle strength
15883210|NCT03780205|Other|Prescription glasses for bilateral amblyopia|Correction of refractive error with prescription glasses both eyes
15883211|NCT03780205|Other|Prescription glasses for unilateral amblyopia|Correction of asymmetric refractive errors with lenses
15883212|NCT03780192|Device|Inspiron Sirolimus Eluting Stent|Bifurcation treatment using provisional stent technique
15883213|NCT03780179|Biological|MMRvaxpro|MMRvaxpro vaccine
15883214|NCT03780179|Biological|Placebo|Placebo
15883215|NCT03780166|Drug|Parsaclisib|Parsaclisib administered orally once daily at the cohort-specified dose level.
15883216|NCT03780153|Other|No intervention|Observation study. No intervention
15883217|NCT03780140|Drug|Cefiderocol|Cefiderocol for intravenous infusion
15883452|NCT03778294|Other|Quality-of-Life Assessment|Ancillary studies
15883221|NCT03780075|Drug|1.11GBq of 177Lu-EB-PSMA-617|Patients were intravenous injected with the dose about 1.11GBq (30 mCi) of 177Lu-EB-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles.
15883222|NCT03780075|Drug|1.85GBq of 177Lu-EB-PSMA-617|Patients were intravenous injected with the dose about 1.85GBq (50 mCi) of 177Lu-EB-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles.
15883223|NCT03780075|Drug|3.70GBq of 177Lu-EB-PSMA-617|Patients were intravenous injected with the dose about 3.70GBq (100 mCi) of 177Lu-EB-PSMA-617 every 8 weeks (±1 week) for a maximum of 3 cycles.
15883224|NCT03780062|Biological|S100B protein dosing|Patients under antiplatelet therapy and who have a minor traumatic brain injury will have a blood samples with protein S100B dosage on arrival to the emergency room and after they will have a brain scanner between 4 and 8 hours after the trauma to analyse the negative predictive value with a treshold of 0.105 μg/L
15883225|NCT03780049|Procedure|HAIC of FOLFOX|administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
15883226|NCT03780049|Drug|H101|Patients receive H101 0.5ml dissolved in 10ml normal saline in each session of HAIC
15883227|NCT03780049|Drug|Placebos|Patients receive normal saline 10ml in each session of HAIC
15883228|NCT03780036|Device|Megaprosthetic Implants the Next Generation (MING)|Use of either porous of porous+hydroxyapathite collars.
15883229|NCT03780023|Other|Questionnaire|All patients will receive three questionnaires at four different time points during their radiation treatment. The time points are 1) before treatment, 2) during the first week of treatment, 3) at the end of treatment (6-8 weeks after treatment begins), and 4) one year after treatment ends.
15883230|NCT03780010|Drug|TRC105|Dose-finding study of TRC105 in combination with standard dose bevacizumab and paclitaxel/carboplatin in treatment-naive patients with stage IV non-squamous NSCLC.
15883231|NCT03779997|Behavioral|Video-based DOT Application|Participants will be asked to record daily videos of themselves confirming daily ingestion of their buprenorphine. Clinical staff (i.e. physicians, nurses and medical assistants) of patients enrolled in the intervention group will be given training and the opportunity to review medication taking videos.
15883232|NCT03779971|Other|Control Diet|Participants will consume a diet prepared and provided by the USDA Nutrition Center. The diet will contain no pulses, legumes, or beans.
15883233|NCT03779971|Other|Lentil Containing Diet|Participants will consume a diet prepared and provided by the USDA Nutrition Center. The diet will contain lentils.
15883234|NCT03779971|Other|Chickpea Containing Diet|Participants will consume a diet prepared and provided by the USDA Nutrition Center. The diet will contain chickpeas.
15883235|NCT03779958|Other|Mobile App|a mobile app that demonstrates hand therapy exercises
15883236|NCT03779945|Biological|autologous platelet rich plasma|adding autologous platelet rich plasma to the bone graft harvested from the patient
15883237|NCT03779945|Procedure|posteriolateral lumbar fusion only|performing posteriolateral lumbar fusion without using platelet rich plasma
15883238|NCT03779919|Device|extracorporeal shock wave|Extracorporeal shock wave therapy uses acoustic waves to fragment calcific deposits. Variables of the settings include dose (low or high energy), duration (impulses), and the interval of administration.
15883239|NCT03779906|Drug|Isovue|Isovue will be given to all subjects per the standard of clinical care.
15883240|NCT03779893|Combination Product|BioCoat® by Premier®.|Bioactive pits and fissure sealant
15883241|NCT03779893|Combination Product|3M™ Clinpro™ Sealant.|conventional pits and fissure sealant
15883242|NCT03779867|Behavioral|Exercise Intervention|Undergo acute exercise
15883243|NCT03779867|Other|Resting|Seated resting
15883244|NCT03779867|Other|Biomarker Analysis|Correlative studies
15883245|NCT03779867|Other|Questionnaire Administration|Ancillary studies
15883246|NCT03779854|Radiation|Total-Body Irradiation|Undergo TBI
15883247|NCT03779854|Drug|Thiotepa|Given IV
15883248|NCT03779854|Drug|Fludarabine|Given IV
15883249|NCT03779854|Drug|Cyclophosphamide|Given IV
15883250|NCT03779854|Drug|Busulfan|Given IV
15883251|NCT03779854|Procedure|Allogeneic Bone Marrow Transplantation|Receive unmanipulated T cell replete BM
15883252|NCT03779854|Drug|Tacrolimus|Given IV
15883253|NCT03779854|Drug|Methotrexate|Given IV
15883254|NCT03779854|Procedure|Naive T Cell-Depleted Hematopoietic Stem Cell Transplantation|Receive naive T-cell depleted PBSCs
15883255|NCT03779841|Drug|AGN-151607|Injections will be made into each 1 of 5 fat pads. The total injection volume into each fat pad will be 1 mL. One-time treatment.
15883256|NCT03779841|Drug|Placebo|Injections of placebo will be made into each 1 of 5 fat pads. The total injection volume into each fat pad will be 1 mL. One-time treatment.
15883257|NCT03779828|Device|HOME LINK|Telemonitoring system which include web platform and connected devices.
15883258|NCT03779815|Drug|[18F]Florbetaben|"Drug: [18F]Florbetaben
~[18F]Florbetaben PET/CT Imaging for detecting amyloidosis in multiple myeloma
~Other name: Neuraceq
~Amount: 300 MBq ± 20% bolus, 10mL intravenously"
15883259|NCT03779802|Other|Device programming of ABBOTT CRT pacemaker or defibrillator|Comparison of the acute hemodynamic effect of three modes of stimulation in ABBOTT CRT devices (Biventricular, SyncAV and MPP modes) by using the Finapress® NOVA method to assess the highest systolic blood pressure (SBP) during the programming session Comparison of the acute hemodynamic effect of three modes of stimulation in ABBOTT CRT devices (Biventricular, SyncAV and MPP modes) by using the Finapress® NOVA method to assess the highest systolic blood pressure (SBP) during the programming session.
15883260|NCT03779789|Drug|Vortioxetine|"Antidepressant classified under the category other antidepressants according to the ATC/DDD index [ATC=Anatomical Therapeutic Chemical Classification System; DDD=Defined Daily Dose]. The dose will be flexible according to the clinical evaluation and in accordance with doses reported for elderly in the Summaries of Product Characteristics (available: https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/home) (namely: 5-20 mg/day)."
15883261|NCT03779789|Drug|Sertraline|"Antidepressant classified under the category Selective serotonin reuptake inhibitors according to the ATC/DDD index. The dose will be flexible according to the clinical evaluation and in accordance with doses reported for elderly in the Summaries of Product Characteristics (available: https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/home) (namely: 50-200 mg/day)."
15883306|NCT03779412|Behavioral|The Happiness Trap|Participants assigned to this condition will be asked to read this self-help book over an 8-week period.
15883262|NCT03779789|Drug|citalopram|"Antidepressant classified under the category Selective serotonin reuptake inhibitors according to the ATC/DDD index. The dose will be flexible according to the clinical evaluation and in accordance with doses reported for elderly in the Summaries of Product Characteristics (available: https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/home) (namely: 10-20 mg/day)."
15883263|NCT03779789|Drug|Escitalopram|"Antidepressant classified under the category Selective serotonin reuptake inhibitors according to the ATC/DDD index. The dose will be flexible according to the clinical evaluation and in accordance with doses reported for elderly in the Summaries of Product Characteristics (available: https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/home) (namely: 5-10 mg/day)."
15883264|NCT03779789|Drug|Paroxetine|"Antidepressant classified under the category Selective serotonin reuptake inhibitors according to the ATC/DDD index. The dose will be flexible according to the clinical evaluation and in accordance with doses reported for elderly in the Summaries of Product Characteristics (available: https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/home) (namely: 20-40 mg/day)."
15883265|NCT03779789|Drug|Fluoxetine|"Antidepressant classified under the category Selective serotonin reuptake inhibitors according to the ATC/DDD index. The dose will be flexible according to the clinical evaluation and in accordance with doses reported for elderly in the Summaries of Product Characteristics (available: https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/home) (namely: 20-60 mg/day)."
15883266|NCT03779789|Drug|Fluvoxamine|"Antidepressant classified under the category Selective serotonin reuptake inhibitors according to the ATC/DDD index. The dose will be flexible according to the clinical evaluation and in accordance with doses reported for elderly in the Summaries of Product Characteristics (available: https://farmaci.agenziafarmaco.gov.it/bancadatifarmaci/home) (namely: 100-300 mg/day)."
15883267|NCT03779776|Other|Vitamin AD|In Vitamin AD group, the very preterm infants will receive the daily vitamin AD with vitamin A at 1500 IU/day and vitamin D at 500 IU/day in drop form added to their enteral feeds when minimal feeding is introduced, and continue to 28 days or discharge. In this group ,the patient also will receive standard intravenous multivitamin preparation (1 ml/kg/d,containing VA 230 IU/kg/d, VD 80 IU/kg/d) within daily on parenteral nutrition until fed 120ml/kg.
15883268|NCT03779776|Other|Control|In this group ,the patient will only receive standard intravenous multivitamin preparation (1 ml/kg/d,containing VA 230 IU/kg/d, VD 80 IU/kg/d) within daily on parenteral nutrition until fed 120ml/kg.
15883269|NCT03779750|Diagnostic Test|s.creatinine|All ESRD patients on regular hemodialysis in dialysis unit of Assiut university Hospital duing one year. will be subjected to 3- Routine investigations including complete blood picture ,blood urea , s.creatinine,urine analysis , calcium, phosphorus, and parathyroid hormone.
15883270|NCT03779737|Behavioral|Muscular Resistance training|
15883271|NCT03779737|Behavioral|Cardiorespiratory training|
15883272|NCT03779737|Behavioral|Habitual training|
15883273|NCT03779724|Other|exercises|
15883274|NCT03779711|Biological|Autologous (self) mononuclear cells derived from umbilical cord blood|The investigational product will be delivered into the right myocardium via sub-epicardial injections of 0.1 mL per kg body weight to achieve the target dose of 1-3 million TNC per kg body weight.at the time of Stage II surgical repair.
15883275|NCT03779711|Procedure|Stage II Surgical repair|This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.
15883276|NCT03779698|Other|BiodentineTM|In the experimental group, BiodentineTM was used following the manufacturer's recommendations. The whole pulp chamber was entirely filled with BiodentineTM until the occlusal surface. Follow-up was done for all children clinically at 3, 6 and 12 months and radiographically at 6 and 12 months.
15883277|NCT03779698|Drug|Formocresol|In control group, a sterile cotton pellet moistened with 1:5 concentration formocresol then blotted to remove excess was placed for 5 minutes on the pulp stumps and then the pulps were covered with zinc oxide-eugenol (IRM; Dentsply, Milford, DE) dressing. Follow-up was done for all children clinically at 3, 6 and 12 months and radiographically at 6 and 12 months.
15883278|NCT03779685|Procedure|General anesthesia|Sevoflurane and morphine
15883279|NCT03779685|Procedure|Regional anesthesia|Paravertebral block
15883280|NCT03779672|Drug|Memantine Hydrochloride 10 mg|"Week #1: 5 mg id (am), 1 caps
~Week #2: 5 mg bid (am and pm), 2 caps
~Weeks #3-6: 5 mg am & 2x 5 mg pm, 3 caps
~Weeks #7-8: Washout
~Placebo
~Week #9: id (am), 1 caps
~Week #10: bid (am and pm), 2 caps
~Weeks #11-14: 1 caps am & 2 caps pm, 3 caps
~OR Placebo
~Week #1: id (am), 1 caps
~Week #2: bid (am and pm), 2 caps
~Weeks #3-6: 1 caps am & 2 caps pm, 3 caps
~Weeks #7-8: Washout
~Memantine
~Week #9: 5 mg id (am), 1 caps
~Week #10: 5 mg bid (am and pm), 2 caps
~Weeks #11-14: 5 mg am & 2x 5 mg pm, 3 caps"
15883281|NCT03779659|Device|Synapse TENS device|At the time of local anesthetic application the TENS device will be activated and placed on the buccal and lingual alveolar mucosa adjacent to the tooth receiving the restorative treatment using the pad applicator. The tip of the device with the electrodes are placed in a vertical up and down motion for approximately ten seconds. Following this, the level of pain and anxiety are measured using the Wong Baker Scale and Visual Analog Scale. The TENS device is used for achieving localized pain relief at the site of local anesthetic injection prior to injecting the anesthetic agent (such as lidocaine or articaine). Following this, once the clinician ensures that the patient is pain free then local anesthetic injection is given and following that the dental procedures are conducted.
15883282|NCT03779659|Drug|Topical anesthetic gel|"The local anesthetic gel is typically used for achieving localized pain relief at the site of local anesthetic injection and this is part of standard care that is followed prior to dental procedures.
~The amount of local anesthetic used will not exceed the maximum allowable dose, which will be calculated for each patient based on his/her age and weight prior to the dental procedure"
15883307|NCT03779412|Behavioral|A Mindfulness-Based Stress Reduction Workbook|Participants assigned to this condition will be asked to read this self-help book over an 8-week period.
15883308|NCT03779399|Other|Assessment of percentage of Treg, Th17, NKT and serum level of HE4, CA125 and ROMA.|Treg, Th17, NKT cells in peripheral blood and ovarian tissue and serum level of HE4, CA125 and ROMA.
15883309|NCT03779386|Other|music|music during labor and delivery
15883283|NCT03779646|Drug|Bisoprolol Fumarate|Bisoprolol was initiated at a dose of 1.25 mg every 24hr. At subsequent biweekly visits, the bisoprolol dose was increased 1.25mg progressively until a daily dose of 0.2mg/kg or the maximum tolerated dose (The rest heart rate <75bpm and systolic blood pressure <90mmHg) is achieved. If the participant feel dizziness or the rest heart rate below 60 bpm or systolic blood pressure below 85mmHg or there is any new onset contraindication to bisoprolol, the doctor will decide to return back to the previous dose or stop bisoprolol. Each time the dose is increased, the medication is administered in an outpatient clinic setting, with assessment of the participant's heart rate, blood pressure, symptoms and ECG. Once reach the target dose, the patients will be followed up every 8 weeks in an face-to-face or video visit. After 12 months , the participants will repeat cardiac MR besides heart rate, blood pressure, symptoms, ECG and brain natriuretic peptide(BNP), echocardiography records.
15883284|NCT03779633|Drug|Linoladiol Estradiol|"Linoladiol Estradiol Initial dose (week 1): 1 application (2g Linoladiol = 0.2mg Estradiol) every day for the first week Maintenance dose 1 (week 2) : 1 application (2g Linoladiol = 0.2mg Estradiol) every 48 hours the following week.
~Maintenance dose 2 (week 3-6): 1 application (2g Linoladiol = 0.2mg Estradiol) twice per week the following 4 weeks.
~Route of administration: intravaginally by means of a calibrated applicator before retiring at night Duration: 6 weeks"
15883285|NCT03779633|Other|Placebo vaginal cream|"Initial dose (week 1): 1 application every day for the first week Maintenance dose 1 (week 2) : 1 application every 48 hours the following week.
~Maintenance dose 2 (week 3-6): 1 application twice per week the following 4 weeks.
~Route of administration: intravaginally by means of a calibrated applicator before retiring at night Duration: 6 weeks"
15883286|NCT03779620|Device|Ultrasound treatment of Calcified aortic valve|Ultrasound treatment of calcified aortic valve causing symptomatic aortic valve stenosis in patients who are not eligible for valve replacement
15883287|NCT03779607|Other|Celtra Press|"new class of zirconia-reinforced lithium silicate material available to labs for pressing. This unique material provides top aesthetics and is virtually impossible to tell apart from a natural tooth.
~Celtra Press is a multiphase ceramic consisting of a glass matrix and lithium disilicate crystals having a crystal length of about 1.5 µm plus nano-scale lithium phosphate . In addition to Li2O and SiO2, Celtra Press contains about 10% zirconia (ZrO2), which is dissolved completely in the glass phase rather than in crystalline form. Celtra Press is characterized by a high strength of about 500 MPa and excellent flow properties during pressing."
15883288|NCT03779594|Drug|Acetazolamide|Patients will be assign and treated by acetazolamide from time of allocation until surgery (2-6 weeks after treatment initiation). The maximal dose of acetazolamide will be the same dose used to treat glaucoma, considering similarity of patients' characteristics, such as age and polypharmacy. We will start at a low dose of 250 mg once a day, and increase it slowly to a maximal dose of 500 mg twice a day. Dose will be individualized according to side-effects and tolerability. Renal and liver function tests will be performed before initiation of treatment, and will be examined again two weeks after treatment had begun.
15883289|NCT03779581|Other|De-Rotation breathing Exercises|De-rotation Breathing Exercises are the group of spinal extension, lateral spinal flexion and rotational exercises performed in synchrony with deep breathing. Exercises are performed in a sitting position with feet firmly placed on the ground. The therapist will stand behind the patient with a medicine ball or a small Swiss ball for the patient to receive while the patient rotates and laterally bend the trunk towards the convexity of scoliosis curvature. The patient is instructed to breathe in deeply during lateral bend and rotation in order to maximally expand the chest wall. Expiration involves relaxation while returning to the neutral position. Later, patients are instructed to extend their back along with former maneuver.
15883290|NCT03779568|Other|Dose adjustment of bupivacaine|Spinal bupivacaine dose will be adjusted according to previous patient experience.
15883291|NCT03779555|Other|Medication Event Monitoring System|-Microchipped bottle cap
15883292|NCT03779542|Procedure|cataract surgery|phacoemulsification and intraocular lens implantation
15883293|NCT03779529|Dietary Supplement|Olive oil|Intervention includes dosage and amount of biophenols administered daily
15883294|NCT03779516|Other|Saline|Effect of saline on postoperative sore throat
15883295|NCT03779516|Other|Lidocaine|Effect of nebulized lidocaine on postoperative sore throat
15883296|NCT03779503|Device|midafilcon A|midafilcon A 1 day daily disposable contact lens
15883297|NCT03779503|Device|somofilcon A|somofilcon A 1 day daily disposable contact lens
15883298|NCT03779490|Device|Transcatheter Tricuspid Valve Repair|Transcatheter Tricuspid Valve Repair with Edwards Cardioband TR
15883299|NCT03779477|Behavioral|Coping with Stress Course|The Coping with Stress Program is a group program, which is developed by Clarke and Lewinson (1995) for the prevention of depression in high-risk adolescents. It is based on cognitive-behavioral therapy principles and contains psychoeducation and cognitive-behavioral therapy interventions. There are handbooks available for the group leader of the program and the participating adolescents. In the handbook developed for the group leader, there is detailed information about the objective of each session and the implemented interventions. The adolescents will find lists organized for the fulfillment of the tasks in the handbook prepared for them. The handbooks of the program were translated in Turkish and experts were consulted for their validity.
15883300|NCT03779464|Drug|S1 or Gemcitabine|Gemcitabine 1000 mg/m² (D1, D8, q3w) and S-1 (40 mg BID for body surface area < 1.25 m²; 50 mg BID for body surface area of 1.25-1.5 m²; and 60 mg BID for body surface area >1.5 m²; D1-14, q3w)
15883301|NCT03779451|Drug|17-OHPC|received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 26-28 week and up to 37-weeks' gestation or delivery.
15883302|NCT03779451|Drug|vaginal progesterone|vaginal progesterone suppositories (Cyclogest vaginal suppository) in a dose of 400 mg daily starting at 26-28 weeks of gestation till 37 weeks of gestation or delivery
15883303|NCT03779438|Drug|17-OHPC|patients received weekly 250 mg 17 alpha-hydroxyprogesterone-caproate (cidolut depot) intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery
15883304|NCT03779438|Drug|placebo to 17-OHPC|patients received weekly placebo to17 alpha-hydroxyprogesterone-caproate intramuscular injections started at 24-26 week and up to 37-weeks' gestation or delivery
15883305|NCT03779425|Other|Virtual Reality Physical Therapy|Participants will undergo a non-weight bearing knee range of motion virtual reality physical therapy session.
15883411|NCT03778593|Drug|5% dextrose water|mix fluid with 5-FU, leucovorin, irinotecan, and oxaliplatin
15883310|NCT03779373|Other|Use of a decision support system on the EV1000 monitor (AFM mode)|The way to administer fluid is based on the same monitoring device but will differ by the way fluid is given ( following a manual GDFT protocol versus following recommendation from an active clinical deicsion support system for fluid administration called AFM (assisted fluid management)
15883311|NCT03779360|Drug|Erythromycin 4% topical gel formulation:|7 day pre-treatment with erythromycin and clindamycin applied twice daily on marked area on left (erythromycin) and right side (clindamycin) of the volar lower arm. Erythromycin is a bacteriostatic antibiotic that belongs to the macrolide group of antibiotics. Macrolides act as bacteriostatic by reversibly binding to the P site on the 50S subunit of bacterial ribosomes. A topical gel formulation with hyprolose and ethanol.
15883312|NCT03779360|Drug|Clindamycin 1% lotion formulation:|7 day pre-treatment with erythromycin and clindamycin applied twice daily on marked area on left (erythromycin) and right side (clindamycin) of the volar lower arm. Clindamcin is a bacteriostatic antibiotic that belongs to the lincosamide group of antibiotics. Lincosamides act as bacteriostatic by reversibly binding to the P site on the 50S subunit of bacterial ribosomes. A topical lotion formulation with ethanol.
15883313|NCT03779360|Drug|Prednisolone tablet (0.5mg/kg; parallel comparison):|2 day pre-treatment with prednisolone daily dose 0.5mg/kg (0.25mg/kg in the morning and 0.25mg/kg in the evening). Prednisolone tablet (0.5mg/kg; parallel comparison): Prednisolone is a synthetic corticosteroid with predominant glucocorticoid activity and as such it is widely used in the treatment for inflammatory and autoimmune diseases. Prednisolone exerts its effect by binding to cytoplasmic glucocorticoid receptors and subsequently activates glucocorticoid receptor mediated gene expression. This results in synthesis of certain anti-inflammatory proteins, while inhibiting the synthesis of certain inflammatory mediators.
15883314|NCT03779360|Drug|Clobetasol propionate 0.05% topical formulation (crossover comparison):|"2 day pre-treatment with clobetasol propionate 0.05% topical formulation applied twice daily on marked area on left or right side of the volar lower arm.
~Clobetasol propionate 0.05% topical formulation (crossover comparison):
~Clobetasol propionate is a potent synthetic corticosteroid with anti-inflammatory, anti-pruritic, and vasoconstrictive properties. Clobetasol propionate exerts its effect by binding to cytoplasmic glucocorticoid receptors and subsequently activates glucocorticoid receptor mediated gene expression. This results in synthesis of certain anti-inflammatory proteins, while inhibiting the synthesis of certain inflammatory mediators. Specifically, clobetasol propionate appears to induce phospholipase A2 inhibitory proteins, thereby controlling the release of the inflammatory precursor arachidonic acid from membrane phospholipids by phospholipase A2."
15883315|NCT03779360|Other|Lipopolysaccharide|As TLR4 agonist, purified lipopolysaccharide prepared from Escherichia Coli: 113: H10:K negative (U.S. Standard Reference Endotoxin) will be used. This LPS batch is manufactured in the US by the National Institute of Health (NIH). Subjects will receive two intradermal doses of LPS in each forearm on day 0 (4 LPS injections in total, except for subjects 1-6 who receive none and subjects 25-27 will receive 2 LPS injections, only in the right arm). The dose per injection is 10 ng.
15883316|NCT03779347|Drug|Praziquantel|Praziquantel to treat schistosomiasis during pregnancy
15883317|NCT03779347|Diagnostic Test|UCP-LF CAA|UCP-LF CAA to diagnose Schistosomiasis during pregnancy
15883318|NCT03779347|Diagnostic Test|composite diagnostic|composite diagnostic reference test based on extensive egg microscopy, serology, qPCR on egg DNA, and POC-CCA to diagnose Schistosomiasis during pregnancy
15883319|NCT03779334|Drug|Risdiplam|Risdiplam will be administered orally.
15883320|NCT03779321|Other|Acceptability|Food samples two formulations (low and high acceptability levels) of custard were used as experimental meals
15883321|NCT03779308|Device|whole body vibration therapy|The study participants will receive the WBVT when standing still on a vibration platform independently or with own hand support on the platform rail. The vibration protocol is modified from the study by Gusso et al (2016). The WBVT training is of 20 Hertz, a peak-to-peak amplitude of 2 mm and peak acceleration of 15.79m/s or 1.61g. The sessions will be 18 minutes in length, 4 days per week for 4 weeks. The vibration frequency, duration and amplitude will be progressively increased over 2 weeks to the desired parameters.
15883322|NCT03779295|Device|Pulse laser dye therapy (Device name: Candela Family of Pulsed Dye Laser Systems. 501k Number: K050673.)|The face will be split and randomized, one half will receive pulsed laser dye therapy.
15883323|NCT03779295|Drug|Clindamycin|The entire face (both halves) will receive clindamycin.
15883324|NCT03779282|Drug|Dexmedetomidine|see descriptions
15883325|NCT03779269|Other|meditation|meditation effect assessment using assessment tools.
15883326|NCT03779256|Procedure|2D transvaginal ultrasound|"Transvaginal ultrasound is part of routine pre-operative examination of the women before surgery is scheduled. Described surgical treatment interventions is standard practice used to alleviate patient symptoms.
~Women recruited at Oslo university hospital, Norway will also have an MRI performed pre-operatively."
15883327|NCT03779243|Dietary Supplement|Melatonin 5mg and Sleep Education|Melatonin 5mg daily and sleep education for 6 weeks following injury or surgery.
15883328|NCT03779243|Other|Placebo|Daily placebo pills for 6 weeks following injury or surgery.
15883329|NCT03779230|Drug|L19TNF|Patients will be assigned to the following increasing dose levels of L19TNF: 10 and 13 μg/kg.
15883330|NCT03779217|Other|screening mammography|As indicated by international guidelines authors will perform screening mammography in all asymptomatic women.
15883331|NCT03779204|Behavioral|Mentorship|The mentors will be encouraged to incorporate the key relationship-based components of natural mentors (e.g., a 'coach' or 'cheerleader' role) to assist with mainstream integration. The mentors will have more flexibility than a typical formal mentorship program in the types of activities they pursue with their mentees. They will not be mandated to attend shelter-based social events, but rather engage in activities that direct their mentees away from the shelter system (and their old identities as homeless youth) and toward the mainstream (e.g., meeting for coffee at a local university campus). All of the mentors will meet monthly with their mentees for two years. In addition, the mentor will be encouraged to touch base with their mentee via phone or text message every week. If a mentor is unable to continue their role and there are at least six months left in the study, the study participant will be matched with a new mentor.
15883332|NCT03779204|Behavioral|Rent Subsidies|Participants will receive rent subsidies ($500 for those living in Toronto, $400 for those living in Hamilton or St. Catherine's due to differences in cost of living) for 24 months.
15883453|NCT03778294|Other|Questionnaire Administration|Ancillary studies
15883333|NCT03779191|Drug|Alectinib|Alectinib dosed 600 mg twice a day (BID) with meals until disease progression, unacceptable toxicity, or other reasons specified in the protocol
15883334|NCT03779191|Drug|Bevacizumab|Bevacizumab 15 mg/kg intravenously every 3 weeks until disease progression, unacceptable toxicity, or other reasons specified in the protocol
15883335|NCT03779178|Drug|Landiolol|Landiolol perfusion over 120 minutes in incremental doses : 0.5, 1, 2, 5 and 10 µg/kg/min. Doses are modified every 20 minutes
15883336|NCT03779178|Drug|Placebo|Placebo perfusion is sodium chloride NaCl 0.9% over 120 minutes in incremental doses : 0.03, 0.06, 0.12, 0.3 and 0.6 mL/kg/h. Doses are modified every 20 minutes. Perfusion are similar in landiolol group to preserve blind.
15883337|NCT03779139|Procedure|Intrahepatic islets and islets in the omental pouch|Patients with islet harvest of >5000 islet equivalents per kg body weight will be randomized in a 1:1 ratio to 4000 IEq/kg delivered via intraportal route and the remainder implanted into a constructed omental pouch.
15883338|NCT03779139|Procedure|Intrahepatic islets alone|This is the standard of care procedure. Patients with islet harvest of >5000 islet equivalents per kg body weight will be randomized in a 1:1 ratio to all islets autotransplanted intrahepatically via the intraportal route.
15883339|NCT03779139|Other|Normal Volunteers|These individuals will undergo metabolic testing as well as islet cell function testing.
15883340|NCT03779126|Device|Electrical stimulation|1) Low frequency electrical stimulation (LF) ; High frequency (HF); Low and High frequency (LHF) ; and sham stimulation. Groups will receive bilaterally electrical stimulation, for 60 minutes, three times a week, during two months.
15883341|NCT03779113|Drug|HMPL-523|Oral HMPL-523
15883342|NCT03779100|Drug|Lenvatinib|12 mg (or 8 mg) once daily (QD) oral dosing.
15883343|NCT03779100|Drug|PD-1 antibody|3mg/kg intravenously every 2 weeks
15883344|NCT03779087|Drug|10d TL quadruple therapy|esomeprazole 40 mg bid., tripotassium dicitrate bismuthate 300mg qid, tetracycline 500 mg qid, levofloxacin 500 mg qd.
15883345|NCT03779087|Drug|10d AL quadruple therapy|esomeprazole 40 mg bid., tripotassium dicitrate bismuthate 300mg qid, amoxicillin 500 mg qid, levofloxacin 500 mg qd.
15883346|NCT03779074|Drug|10d bismuth quadruple therapy|rabeprazole 20 mg b.i.d. plus tripotassium dicitrate bismuthate 300 mg, tetracycline 500 mg and metronidazole 250 mg q.i.d. for 10 days
15883347|NCT03779074|Drug|14d hybrid therapy|a dual regimen with rabeprazole 20 mg and amoxicillin 1 g b.i.d. for 7 days followed by a quadruple regimen with rabeprazole 20 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg b.i.d. for 7 days
15883348|NCT03779074|Drug|14D high-dose dual therapy|rabeprazole 20 mg and amoxicillin 750 mg q.i.d. for 14 days
15883349|NCT03779061|Drug|Remimazolam Tosilate|Initial dose plus supplemental doses as necessary
15883350|NCT03779061|Drug|Propofol|Initial dose plus supplemental doses as necessary
15883351|NCT03779048|Behavioral|Behavioral Treatment|Behavioral treatment (BT) for weight loss includes diet and physical activity recommendations and behavior therapy strategies. All participants will complete an initial 4-week BT run-in, delivered in individual, 20-30 minute weekly sessions. After the end of the run-in, participants will be offered an additional 24 weeks of 20-30 minute individual BT sessions, occurring weekly for the first 12 weeks and every other week for the last 12 weeks (total of 18 visits).
15883352|NCT03779048|Drug|Placebo|The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
15883353|NCT03779048|Drug|Phentermine 15 MG|The study medication (placebo or phentermine 15.0 mg) is a once-daily self-administered pill.
15883354|NCT03779035|Drug|Gemcitabine|1000mg/m2
15883355|NCT03779035|Drug|Capecitabine|1250mg/m2
15883356|NCT03779022|Genetic|microRNA|The level of microRNA in plasma will be detected by TaqMan in screening phase and by quantitative Real-time PCR (qRT-PCR) in validation phase.
15883357|NCT03779009|Other|ICG-nanocoll (indocyanine green coupled to the human albumin colloidal particle nanocoll)|Under laparoscopic control, 2.0 ml of ICG-nanocoll will be injected into the subserosa at four quadrants around the tumor. Directly after injection, near infrared (NIR) fluorescence images (Olympus, Tokyo, Japan) will be acquired. SLNs will be identified and marked.
15883358|NCT03778996|Drug|Combination metyrosine-derivative, low-dose methoxsalen, phenytoin and sirolimus (MPS)|Daily oral combination therapy for cancer
15883359|NCT03778970|Other|Pain Neuroscience Education|Pain neuroscience education (2 sessions during 40 minutes) administered by an interactive workshop
15883360|NCT03778970|Other|Self-Management Education|A self-management education (2 sessions during 40 minutes) administered by an interactive workshop
15883361|NCT03778970|Other|Movement Control Exercises|Eight sessions of movement control exercises (30 minutes each) + advice to perform the exercises at home twice a week.
15883362|NCT03778957|Drug|Durvalumab|Durvalumab IV (intravenous)
15883363|NCT03778957|Drug|Bevacizumab|Bevacizumab IV (intravenous)
15883364|NCT03778957|Other|Placebo|Saline solution for Durvalumab and/or Bevacizumab masking (IV intravenous)
15883365|NCT03778957|Procedure|Transarterial Chemoembolization (TACE)|TACE (chemo and embolic agent injection into the hepatic artery)
15883366|NCT03778944|Procedure|Mannitol infusion|Infusion of Mannitol 20% at a dose of 0.5 mg/kg to the renal graft donor after induction of anesthesia over 15 minutes.
15883367|NCT03778944|Procedure|Dopamine infusion|Infusion of Dopamine at a dose of 4 microg/kg/min to the renal graft donor after induction of anesthesia till ligation of the renal artery.
15883368|NCT03778944|Procedure|Adequate hydration|Infusion of Ringer Acetate at a rate of 15 ml/kg/hr to the renal graft donor after induction of anesthesia till ligation of the renal artery.
15883369|NCT03778931|Drug|Elacestrant|400 mg/day once daily oral dosing
15883370|NCT03778931|Drug|Standard of Care|"Fulvestrant: 500 mg administered intramuscularly (IM) into the buttocks as two 5 mL injections on C1D1, C1D15 and C2D1 and Day 1 of every subsequent 28-day cycle
~Anastrozole 1 mg/day on a continuous dosing schedule
~Letrozole: 2.5 mg/day on a continuous dosing schedule
~Exemestane: 25 mg/day on a continuous dosing schedule"
15883371|NCT03778918|Other|inflammatory bowel disease|blood based biomarkers in IBD such as REG3 alpha, serum calprotectin and hs-CRP
15883372|NCT03778918|Other|IBS or Normal Control|blood based biomarker compared normal control with IBD
15883373|NCT03778905|Other|Rehabilitation|The stroke patients who admitted to post acute care(PAC) institution would undergo regular rehabilitation.
15883454|NCT03778294|Drug|Temozolomide|Drug
15883374|NCT03778892|Behavioral|'Project Raincoat' Mobile Phone Application|Mobile phone application with weekly input channels for PrEP use, condom use, number of sex partners and sex acts and a calculation of self-HIV risk feedback scoring. Scoring system for attendance of visits, normal blood tests and use of application. Points redeemable for cash. Optional alarm system to remind to take medications and attend visits.
15883375|NCT03778879|Drug|CCX872-B|CCX872-B concurrent with stereotactic body radiation therapy for pancreatic adenocarcinoma.
15883376|NCT03778866|Other|Bicarbonate-buffered handling medium|The investigators will evaluate whether the usual bicarbonate culture medium can replace the HEPES buffered medium effectively.
15883377|NCT03778853|Drug|Anlotinib Hydrochloride|"Anlotinib Hydrochloride ( 12mg, QD, PO, d1-14, 21 days per cycle), take once when limosis in the morning. If patients cannot suffer from AEs, they can get declined dosage.
~Other Name: AL3818"
15883378|NCT03778827|Behavioral|Intensive Center-Based Pivotal Response Treatment (PRT-C)|Intensive Center-Based Pivotal Response Treatment (PRT-C) will consist of a combination of weekly individual parent training sessions and center-based therapy for a total of 13 weekly treatment hours.
15883379|NCT03778814|Biological|TCR-T cells|Engineering TCR-T cells targeting lung tumor and other solid tumor will be transfused back the patients.
15883380|NCT03778801|Diagnostic Test|fibromyalgia syndrome and chronic neck pain|We assessed pain intensity, kinesiophobia, fatigue, depression, physical activity level and disability in patients with fibromyalgia syndrome and chronic neck pain, and healthy individuals in this cross-sectional study.
15883381|NCT03778788|Other|App group|Intervention group the participants will receive a Lifestyle Intervention Program (LIP) with the support of MetS mobile application (MetS app). The MetS app support include app installment and briefing by a research assistant after the educational talk. The participants can view the similar knowledge content related to metabolic syndrome in their own smart phone. In addition, a membership area provides individual support of self- health monitoring, goal setting of exercise plan and exercise record. A user guide of the MetS app will be provided to the participants to take home after the briefing.
15883382|NCT03778788|Other|Booklet group|The participants will additionally receive a Hong Kong version LIP booklet to take home and use for 24 weeks. The major component of the LIP booklet consists of fact of metabolic syndrome, advise of diet, exercise, medication, life style and stress management.
15883383|NCT03778788|Other|control group|Participants will be advised to maintain their usual activities. They will additionally receive a placebo health leaflet. The health leaflets are produced by Department of Health and commonly distributed to the general public. For the ethical reason, those control group participants are freely to receive the LIP booklet after completion of the study at 24 weeks.
15883384|NCT03778775|Diagnostic Test|Liver sitffness measurement|Liver sitffness measurement is performed by FibroTouch, a new-generation of transient elastography with the tesing interval between liver sitffness measurement and esophagogastroduodenoscopy less than one week.
15883385|NCT03778762|Procedure|Blind tracheal intubation through AirQ|underwent blind intubation with correction manoeuvres
15883386|NCT03778762|Procedure|Fiberscopic tracheal intubation through AirQ|: underwent fibreoptic guided intubation
15883387|NCT03778749|Diagnostic Test|TOF measurements|The investigators will determine how the TOF% values vary in each individual patient, over time, in ICU.
15883388|NCT03778736|Other|Cumulase denudation|Testing the effect of cumulase for women with poor oocyte yield due to poor ovarian reserve
15883389|NCT03778723|Drug|Total intravenous anesthesia (TIVA)|Propofol (1.5-2 mg/kg/h) infusion, Midazolam (0.12 mg/kg/h) infusion
15883390|NCT03778723|Drug|Inhalation Anesthesia|Sevoflurane at a concentration of 2-2.5%
15883391|NCT03778723|Drug|Rescue fentanyl|Fentanyl in repeated doses (50 µg) when needed (heart rate or mean arterial blood pressure increase more than 20% of the basal value) are used for maintenance of analgesia
15883392|NCT03778697|Procedure|Endoscopic Sleeve Gastroplasty|Endoscopic full-thickness suture system to plicate the greater curvature of the stomach
15883393|NCT03778684|Diagnostic Test|Visceral fat thickness|An initial longitudinal sweep will be done from the xiphoid process to the umbilicus to determine the area of maximum pre-peritoneal fat thickness.
15883394|NCT03778684|Diagnostic Test|Body mass index|Weight and height will be measured with subjects in a standing position wearing light clothes and no shoes.
15883398|NCT03778658|Behavioral|Physical Activity Intervention|Participants will engage in a multimodal aerobic and strength training intervention.
15883399|NCT03778645|Procedure|Adrenal Venous Sampling|Adrenal Venous Sampling via an Antecubital Approach
15883400|NCT03778632|Behavioral|individualized desensitization exercises|implementing individualized desensitization exercises in standard application of intensive stuttering group therapy for school-age children who stutter
15883401|NCT03778619|Drug|Rituximab|weekly administration of Rituximab 375mg/m2 during cycle 1 and 2, monthly administration from cycle 3(up to cycle 6)
15883402|NCT03778619|Drug|Fludarabine|administration of fludarabine 20mg/m2 for 3 consecutive days starting at 3 days before the 1st, 3rd, and 5th cycle of the first rituximab infusion for that cycle
15883403|NCT03778619|Drug|Cyclophosphamide|administration of fludarabine 250mg/m2 for 3 consecutive days starting at 3 days before the 1st, 3rd, and 5th cycle of the first rituximab infusion for that cycle
15883404|NCT03778619|Biological|MG4101(allogeneic Natural Killer cell)|administration every fortnight for each cycle, beginning with the 1st dose of rituximab for that cycle.
15883405|NCT03778619|Drug|Interleukin-2|1 x 10^6 IU/m2, together with MG4101
15883406|NCT03778606|Dietary Supplement|Potato starch|Potato starch will be given twice a day for up to 14 days, discharge, or death, whichever occurs first.
15883407|NCT03778593|Drug|5-Fluorouracil|D1-2 5-Fluorouracil 1000 mg/m2 + 5DW 1L continuous IV over 23 hours q 2 weeks
15883408|NCT03778593|Drug|Leucovorin|D1 Leucovorin 400 mg/m2 + 5DW 200 ml mix IV over 2 hours q 2 weeks
15883409|NCT03778593|Drug|Irinotecan|D1 Irinotecan 135 mg/m2 + 5DW 500 mL mix IV over 2 hours (concurrent with the leucovorin infusion) q 2weeks
15883410|NCT03778593|Drug|Oxaliplatin|D1 Oxaliplatin 65 mg/m2 + 5DW 200 mL mix IV over 2 hours q 2 weeks
15883412|NCT03778580|Dietary Supplement|Pyridoxamine Dihydrochloride|pyridoxamine dihydrochloride (over- the- counter type of vitamin B6) 200 mg po bid
15883413|NCT03778580|Drug|placebo|placebo
15883414|NCT03778567|Drug|Telbivudine|CHB patients who are receiving adefovir or tenofovir disoproxil fumarate are recruited. At the time of recruitment (0 month, baseline), lamivudine is switched to telbivudine while adefovir or tenofovir disoproxil fumarate was continued. The patients are followed-up for 24 months.
15883415|NCT03778554|Drug|Metoprolol Succinate|Eligible patients randomized to receive long-term therapy with oral beta-blockade
15883416|NCT03778554|Drug|Bisoprolol|Eligible patients randomized to receive long-term therapy with oral beta-blockade
15883417|NCT03778554|Drug|Carvedilol|Eligible patients randomized to receive long-term therapy with oral beta-blockade
15883418|NCT03778554|Drug|Nebivolol|Eligible patients randomized to receive long-term therapy with oral beta-blockade
15883419|NCT03778541|Drug|Temozolomide|75mg/m2/d concurrent with radiotherapy, taken for at least 20 days.
15883420|NCT03778541|Radiation|hypofractionated radiotherapy|the regular radiation dose prescription is 52 Gy in 13 fractions or 52.5 Gy in 15 fractions.
15883421|NCT03778528|Procedure|cataract surgery|tissue collection.
15883422|NCT03778515|Diagnostic Test|MRI|Observational Study of novel MR imaging and image processing techniques that will provide reliable and fully quantitative evaluation of inflammation, chronic structural changes and vascularity in patients with Ankylosing Spondylitis (AS).
15883423|NCT03778502|Drug|Direct Oral Anticoagulants|Consecutive adult patients with objectively diagnosed unusual site venous thrombosis and treated with one of the DOAC (e.g. apixaban, dabigatran, edoxaban, rivaroxaban) will be eligible for this observational prospective registry
15883425|NCT03778476|Other|Isometric Exercise|Participants will be asked to hold a submaximal voluntary contraction of the quadriceps muscle as long as they can (task failure).
15883426|NCT03778463|Other|Synovectomy|Removal of the synovium during total knee arthroplasty
15883427|NCT03778450|Drug|Analgesics, Opioid|"Patients are included in the long-term opioid group if they started an opioid-therapy between 2013 and 2017 and received consecutive prescriptions for opioid medications over a minimum of 3 quarters, over a 60-month period between January 1, 2013, and December 31, 2017. The treatment will be assessed using the ATC codes of opioid
~treatment N02AA01, N02AA05, N02AB03, N02AE01, N02AX02, N02AX01, N02AX06) reported in reimbursed medicines to patients."
15883428|NCT03778450|Drug|Non-Opioid Analgesic|Patients with non-opioid pain medication are included, if they received a medication therapy with anticonvulsants (gabapentin, pregabalin, carbamazepine), antidepressants or non-opioid analgesics (NSAIDs, Metamizole) over a minimum of 3 quarters, over a 60-month period between January 1, 2013, and December 31, 2017. The non-opioid treatment will be assessed using the ATC codes (N03AX12, N03AX16, N03AF01) of treatment reported in reimbursed medicines to patients.
15883429|NCT03778437|Procedure|subclavian vein catheterization|Here we introduced a new freehand method, named as Aiming Method, which facilitated the alignment of injection needles with ultrasound beams. During this aiming method, patient is still positioned in Tredelenburg with the arm abducted to 90° and no needle guidance will be used.
15883430|NCT03778437|Procedure|landmark techniques|The patient is positioned in Tredelenburg with the arm abducted to 90°. Venipuncture should occur 1 cm lateral to the curvature of the middle third of the clavicle with the needle pointing horizontally directed at the sternal notch. If subclavian vein is missing at the first try, withdraw the needle and direct horizontally at the cricoid cartilage at the second try.
15883431|NCT03778437|Procedure|Ultrasound-guided plus needle guide techniques|Subclavian vein catheterization is performed under ultrasound guidance with in-plane technique. The patient is positioned in Tredelenburg with the arm abducted to 90°. During the needle insertion, the needle is secured in the needle guidance device which keeps the alignment of needle and ultrasonic beam.
15883432|NCT03778424|Drug|Rufinamide|Rufinamide up to 45 milligram per kilogram per day (mg/kg/day).
15883433|NCT03778411|Device|VCTE with splenic stiffness measurement|Subjects will undergo vibration controlled transient elastography to measure liver stiffness (LSM) liver steatosis via controlled attenuation parameter (CAP) and splenic stiffness
15883434|NCT03778398|Other|Neurologic music therapy|Customized piano training
15883435|NCT03778385|Other|Exercise|Submaximal exercise is performed in randomized order with the participant seated and the arm supported in an adjustable hand-arm orthosis.
15883436|NCT03778372|Drug|Methadone|see desc above
15883437|NCT03778359|Drug|Leuprorelin|This study was designed to analyze the differences in prognosis and recurrence of patients with endometriosis and adenomyosis after receiving various surgical and medical treatments. This arm intervention is Leuprorelin.
15883438|NCT03778359|Device|Levonorgestrel|This study was designed to analyze the differences in prognosis and recurrence of patients with endometriosis and adenomyosis after receiving various surgical and medical treatments. This arm intervention is Levonorgestrel.
15883439|NCT03778359|Drug|Dienogest|This study was designed to analyze the differences in prognosis and recurrence of patients with endometriosis and adenomyosis after receiving various surgical and medical treatments. This arm intervention is Dienogest.
15883440|NCT03778359|Drug|Progestins|This study was designed to analyze the differences in prognosis and recurrence of patients with endometriosis and adenomyosis after receiving various surgical and medical treatments. This arm intervention is Progestins.
15883441|NCT03778346|Biological|CAR-T therapy in Relapsed/Refractory multiple myeloma|Integrin β7, BCMA, CS1, CD38 and CD138 as the Single or Compound Targets for the Fourth Genenation of CAR-T Cells to treat Relapsed/Refractory multiple myeloma
15883442|NCT03778333|Biological|Autologous mesenchymal stem cells|IV therapy with autologous bone-marrow derived mesenchymal stem cells
15883443|NCT03778320|Drug|CTP-692|Single oral dose
15883444|NCT03778320|Drug|D-Serine|Single oral dose
15883445|NCT03778307|Behavioral|Psychophysiological fear conditioning and extinction task|Behavioral task to assess psychophysiological measures of fear
15883446|NCT03778307|Behavioral|Eyetracking task|Behavioral task to assess dysphoria-relevant attention allocation
15883447|NCT03778294|Procedure|Computed Tomography|Undergo PET/CT
15883448|NCT03778294|Other|Fluorodopa F 18|Given IV
15883449|NCT03778294|Procedure|Magnetic Resonance Imaging|Undergo PET/MRI
15883455|NCT03778281|Drug|Baclofen|Oral baclofen 10mg, 3 times a day for three days, then evaluate the efficacy and side effects
15883456|NCT03778281|Drug|Methoxyclopramide|Intramuscular injection of metoclopramide 10mg, 3 times a day for three days, then evaluate the efficacy and side effects
15883457|NCT03778268|Procedure|sentinel lymph node biopsy|"Injecting carbon nanoparticles (CNP)[Not Equipped with near-infrared fluorescent vascular imager] or CNP combining Indocyanine Green(ICG)[Equipped with near-infrared fluorescent vascular imager].
~Identifying and removing sentinel lymph nodes.
~Staining all nodes using hematoxylin-eosin staining."
15883458|NCT03778255|Procedure|Sentinel Lymph Node Biopsy|"Injecting carbon nanoparticles (CNP)[Not Equipped with near-infrared fluorescent vascular imager] or CNP combining Indocyanine Green(ICG)[Equipped with near-infrared fluorescent vascular imager].
~Identifying and removing sentinel lymph nodes.
~Staining all nodes using hematoxylin-eosin staining."
15883459|NCT03778242|Drug|oxytocin|20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby
15883460|NCT03778242|Drug|TA|1 gm tranexamic acid (TA) in 100 ml saline by slow infusion
15883461|NCT03778242|Drug|placebo to TA|2 placebo ampoules to TA in 100 ml saline by slow infusion
15883462|NCT03778229|Drug|osimertinib|osimertinib (80 mg oral od).
15883463|NCT03778229|Drug|savolitinib|savolitinib (300 mg oral OD or 300 mg oral BID or 600 mg oral OD)
15883464|NCT03778216|Behavioral|Family Based Treatment|
15883465|NCT03778190|Procedure|Corneal Foreign Body Removal|An eye magnet will be brought close to the foreign body on the surface of the eye in an attempt to remove the foreign body.
15883466|NCT03778177|Procedure|transcranial electrical brain stimulation|Pain ratings will be recorded before and after transcranial brain electrical stimulation procedures using a Visual Analog Scale (VAS).
15883467|NCT03778164|Other|Fast Track Partner Services-Sexual Health Intervention|The Partner Services-Sexual Health Intervention enhances the current standard of care by introducing four service innovations to the DOHMH Partner Services program: (1) enhanced field-based combination HIV and STI testing; (2) immediate field-based ARV/PrEP start; (3) navigation to a sexual health clinic for test results and treatment; and (4) enhanced linkage support to facilitate ongoing PrEP or HIV care.
15883468|NCT03778164|Other|Partner Services Standard of Care|Participants in neighborhoods that have not yet been assigned to the intervention condition in the stepped wedge trial will receive standard Partner Services components, including field-based HIV testing and referral to clinical sites for HIV prevention or treatment.
15883469|NCT03778151|Device|REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION|daily treatment session of REPETITIVE TRANSCRANIAL MAGNETIC STIMULATIO will be applied over precuneus for 20 minutes of consecutive blocks of 20Hz pulses for two seconds followed by 28 seconds of no stimulation.
15883470|NCT03778138|Drug|Anlotinib plus Pemetrexed|Anlotinib(12mg QD PO d1-14, 21 days per cycle) plus Pemetrexed (500mg/m2 IV d1)
15883471|NCT03778112|Radiation|SBRT to whole prostate|Those patients with negative mpMRI prostate scan (PI-RADS 0-2) will receive SBRT (36.25 Gy/5 fractions) to the whole prostate
15883472|NCT03778112|Radiation|IMRT followed by mpMRI guided SBRT boost with SIB to intraprostatic lesions|Patients with positive or equivocal mpMRI prostate scan (PI-RADS 3-5) will receive IMRT (45 Gy/25 fractions) to the prostate + seminal vesicles +/- lymph nodes followed by SBRT boost (18 Gy/3 fractions) to the whole prostate with simultaneous integrated boost (21 Gy/3 fractions) to MRI defined intraprostatic lesions
15883473|NCT03778099|Drug|Cinnamon Cap 500 MG|The Cinnamomum cassia (C. aromaticum) capsules will be purchase from Spring Valley company (distributed by Wal-Mart Stores, Inc. USA) by the investigator.
15883474|NCT03778099|Drug|Placebo|450 mg of starch and 50 mg of cinnamon powder
15883475|NCT03778086|Procedure|gonioscopy|gonioscopic observation and grading of iridocorneal angle
15883476|NCT03778073|Drug|Cosibelimab|Intravenous infusion on Days 1 and 15 of every 28-day cycle or only on Day 1 of every 28-day cycle
15883477|NCT03778073|Drug|Cosibelimab + Ublituximab + Bendamustine combination|"Cosibelimab (Intravenous infusion):
~Cycle 1-6 Days 1&15, Cycles 7-12 Day 1, Cycles 15-24 Day 1 every 3 cycles;
~Ublituximab (Intravenous infusion):
~Cycles 1-6 Day 1, Cycles 9-24 every 3 Cycles;
~Bendamustine (Intravenous infusion):
~Cycle 1 Days 2&3, Cycles 2-6 Days 1&2."
15883478|NCT03778073|Drug|Cosibelimab + Ublituximab + Bendamustine combination|"Cosibelimab (Intravenous infusion):
~Cycle 1-12 Day 1, Cycles 15-24 Day 1 every 3 cycles;
~Ublituximab (Intravenous infusion):
~Cycles 1-6 Day 1, Cycles 9-24 every 3 Cycles;
~Bendamustine (Intravenous infusion):
~Cycle 1 Days 2&3, Cycles 2-6 Days 1&2."
15883479|NCT03778060|Device|Cala TWO stimulator|Treatment intervention will consist of subjects undergoing 40 minute sessions of transcutaneous stimulation with the Cala TWO stimulator twice daily for 3 months to reduce hand tremors prior to their undergoing deep brain stimulation 'surgery for treatment of essential tremor at Mayo Clinic.
15883480|NCT03778047|Drug|Enzalutamide|oral
15883481|NCT03778047|Drug|HC1119|oral
15883482|NCT03778034|Other|female with Forward head posture|measuring tmj proprioception with open eyes and closed eyes for mouth opening,right deviation,left deviation and protrusion,cranio vertebral angle and shoulder angle
15883483|NCT03778034|Other|healthy female without (FHP)|measuring tmj proprioception with open eyes and closed eyes for mouth opening,right deviation,left deviation and protrusion,cranio vertebral angle and shoulder angle
15883484|NCT03778021|Behavioral|Behavioral Gardening Exposure|Assist with planting and maintaining the school garden, as well as observe the school garden curriculum and dietary assessment protocols
15883485|NCT03778021|Behavioral|Healthy Eating and Gardening Curriculum|Attend 12 lessons (about 45 minutes each) throughout the school year, during the normal school day, that are focused on healthy eating and gardening, coordinated with the growing season
15883486|NCT03778021|Behavioral|Family Workshops|During Year 3, quarterly healthy eating and gardening workshops for family and community members to attend
15883487|NCT03778008|Drug|Recombinant bovine basic fibroblast growth factor|Recombinant bovine basic fibroblast growth factor is prescribed at the beginning of radiotherapy for free. Patients are asked to start application of recombinant bovine basic fibroblast growth factor at the onset of radiotherapy, four times a day (after meals and before bedtime), until completion of their radiotherapy. All patients will receive conventional health education and medical care for prevention and treatment of radiation-induced oral mucositis. When grade > 3 OM happened, other interventions, such as prophylactic or therapeutic antibacterial therapy, will be used, and radiotherapy should be interrupted.
15883488|NCT03778008|Combination Product|Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and lidocaine composition|Quadruple mixture is prescribed at the beginning of radiotherapy. Patients are asked to start application of quadruple mixture at the onset of radiotherapy, four times a day (before meals and before bedtime), until completion of their radiotherapy. All patients will receive conventional health education and medical care for prevention and treatment of radiation-induced oral mucositis. When grade > 3 OM happened, other interventions, such as prophylactic or therapeutic antibacterial therapy, will be used, and radiotherapy should be interrupted.
15883489|NCT03777982|Drug|Prednisone|Taking advantage of the anti-inflammatory properties of the medication, corticosteroids are used to decrease the swelling around tumors.
15883490|NCT03777982|Drug|Apalutamide|Apalutamide also prevents the androgens from working within the prostate cancer cells, and can ultimately lead to cancer cell death.
15883491|NCT03777982|Drug|Abiraterone Acetate|Abiraterone acetate interferes with an enzyme that is expressed in testicular, adrenal, and prostatic tumor tissues and is required as part of the body's androgen producing process. Because of this interference the amount of androgens produced are decreased. Abiraterone acetate, blocks androgen production at three sources; the testes, the adrenal glands, as well as from the tumor itself
15883492|NCT03777982|Drug|LHRH Agonist or Antagonist|Luteinizing hormone-releasing hormone (LHRH) agonists (also called LHRH analogs or GnRH agonists) are drugs that lower the amount of testosterone made by the testicles
15883493|NCT03777956|Drug|Lacosamide|Lacosamide (50 mg) and identical placebo are given as capsules and taken orally twice a day, up to 200 mg b.i.d.
15883494|NCT03777956|Drug|Placebo|Identical placebo are given as capsules and taken orally twice a day.
15883495|NCT03777943|Procedure|Sampling peritoneal tissue|Resection specimen will be obtained during CRS from normal peritoneum at a distance, normal peritoneum close to a peritoneal metastasis, miliary peritoneal carcinomatosis, and established peritoneal carcinomatosis.
15883496|NCT03777930|Drug|Chemotherapy drugs|According to the NCCN Guidelines
15883497|NCT03777930|Drug|thalidomide and megestrol acetate|The thalidomide and megestrol acetate administration groups were administered with thalidomide 100 mg qn po and megestrol acetate 0.16 qd po for 8 weeks
15883498|NCT03777930|Other|optimal support treatment|Patients who cannot tolerate chemotherapy and other cancer treatments receive optimal support for 8 weeks
15883499|NCT03777930|Drug|thalidomide and megestrol acetate|The thalidomide and megestrol acetate administration groups were administered with thalidomide 100 mg qn po and megestrol acetate 0.16 qd po for 8 weeks
15883500|NCT03777917|Device|Belotero Balance®|Up to 1.0 mL Belotero® Balance per infraorbital hollow (plus up to 0-5 mL per infraorbital hollow during touch-up 1month after baseline injection, as required). Mode of application: subdermal injection.
15883501|NCT03777904|Diagnostic Test|Serum Ferritin level|Serum ferritin level will be collected with other clinical labs and measured in the research lab
15883502|NCT03777904|Diagnostic Test|Serum Ferritin iron content|Blood will be collected with other clinical labs and the iron content in the ferritin will be measured in the research lab
15883503|NCT03777904|Diagnostic Test|Urine Ferritin level|Urine will be collected non-invasively and analyzed for ferritin level
15883504|NCT03777904|Diagnostic Test|Urine ferritin iron content|Urine will be collected non-invasively and analyzed for iron content within the ferritin
15883505|NCT03777891|Combination Product|phonophoresis with different material|phonophoresis with Silicone gel for group A, , Group B: 15 patients (8 males and 7 females) received phonophoresis with Contractubex gel and Group C: 15 patients (9 males and 6 females) received Corticosteroid phonophoresis.
15883506|NCT03777878|Drug|Carbetocin|100 μg carbetocin ampoule will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby
15883507|NCT03777878|Drug|oxytocin|20 IU oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby
15883508|NCT03777878|Drug|TA|2 ampoules of TA in 100 ml saline by slow infusion
15883509|NCT03777878|Drug|placebo to carbetocin|placebo ampoule to carbetocin will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby
15883510|NCT03777878|Drug|placebo to TA|2 placebo ampoules to TA in 100 ml saline by slow infusion
15883511|NCT03777878|Drug|placebo to oxytocin|two placebo ampoules to oxytocin in 500 mL of intravenous solution infusion over 15 min after delivery of the baby
15883512|NCT03777865|Biological|13vPnC|All subjects receive a single dose (0.5mL) of 13vPnC
15883513|NCT03777852|Diagnostic Test|First Questionnaire application|Women with breast cancer will respond to the First Breast Q questionnaire before treatment with breast cancer reconstruction surgery.
15883514|NCT03777852|Diagnostic Test|Second Questionnaire application|Women with breast cancer will respond to the Second Breast Q questionnaire after treatment with breast cancer reconstruction surgery.
15883515|NCT03777839|Diagnostic Test|FDG PET/CT|FDG PET CT imaging with rest perfusion imaging
15883516|NCT03777826|Other|PKU Synergy|PKU Synergy is a citrus flavored, powdered amino-acid mixture (containing traces of Phe, 4,3mg per portion; and 20 gr. Protein Equivalent (PE)) with a tailored amino acid and micronutrient profile adapted for the special requirements of HPA/PKU (Hyperphenylalaninemia/Phenylketonuria) subjects over 10 years of age with an increased Phenylalanine-(Phe) tolerance/intake.
15883517|NCT03777813|Drug|Durvalumab|Radiochemotherapy in standard arm and in experimental arm: 10 weeks (RT 50 Gy and FOLFOX q2w) Immunotherapy in experimental arm only: Patients will received concomitantly a maximum of 12 infusions
15883518|NCT03777813|Combination Product|IMRT 50 Gy + FOLFOX4 simplifIed (oxaliplatin, leucovorin, 5-FU)|Radiochemotherapy in standard arm and in experimental arm: 10 weeks (RT 50 Gy and FOLFOX q2w)
15883519|NCT03777800|Behavioral|Body therapy|"Body therapy involving direct physical treatments, conversations, breathing exercises and relaxation in the sessions. Moreover, the participants are taught how to practice vipassana or awareness meditation every day at home.
~The body therapist works directly with the muscle armour and the treatment sessions have focus on creating a safe environment and enabling cognitive realisation and awareness of symptoms.
~Each participant is assigned a practitioner who acts as contact person and 'lifeline'. Furthermore, a coordinator is assigned in ManuVision who will also act as contact person when needed for the veterans. This provides peace of mind, trust, and ensures retention. The coordinator or the practitioner follows up on the veteran's progress prior to each session."
15883521|NCT03777787|Dietary Supplement|Denatonium Benzoate|A single intragastric administration of denatonium benzoate (1 µmol/kg)
15883522|NCT03777787|Dietary Supplement|Water|A single intragastric administration of water
15883523|NCT03777774|Procedure|Passive Redon subgaleal drains|Passive non-vacuum subgaleal drains will be placed during closing stage of craniectomy. Drain used is closed suction drain system (3.2 mm in outer diameter, 10 French, round and transparent polyvinyl chloride tube with a 400 mL Redon bottle spring evacuator chamber; Privac, Primed, Germany)
15883524|NCT03777774|Procedure|Vacuum Redon subgaleal drains|Active vacuum subgaleal drains will be placed during the closing stage of craniectomy. Drain used is closed suction drain system (3.2 mm in outer diameter, 10 French, round and transparent polyvinyl chloride tube with a 400 mL Redon bottle spring evacuator chamber; Privac, Primed, Germany)
15883525|NCT03777774|Procedure|No Redon subgaleal drains|A subgaleal drain will be placed during the closing stage of craniectomy but it will be clamped. The drain will be unclamped if necessary. Drain used is closed suction drain system (3.2 mm in outer diameter, 10 French, round and transparent polyvinyl chloride tube with a 400 mL Redon bottle spring evacuator chamber; Privac, Primed, Germany)
15883526|NCT03777761|Drug|tucatinib|300mg oral dose
15883527|NCT03777761|Drug|placebo|Matching placebo for tucatinib
15883528|NCT03777761|Drug|moxifloxacin|400mg single oral dose
15883529|NCT03777748|Device|dental implants and stud attachments|
15883530|NCT03777735|Procedure|human bone graft screw|All patients undergo surgical treatment of osteochondral defects in the knee joint with human bone graft screws.
15883531|NCT03777722|Device|Tailored Lighting Intervention|Lighting Intervention - active or placebo
15883532|NCT03777709|Behavioral|FAITH! App|Participants allocated to the intervention arm will complete a 10-week, individual-tailored intervention program utilizing the FAITH! App to promote the AHA LS7 through health education and to increase awareness and skill development while enhancing self-efficacy, self-regulation, and social support for healthy behavior change.
15883533|NCT03777696|Drug|Misoprostol|400 μg of buccal misoprostol
15883534|NCT03777696|Drug|TA|1 gm of tranexamic acid in 100 ml saline iv
15883535|NCT03777696|Drug|placebo to misoprostol|placebo tablets to misoprostol buccal
15883536|NCT03777696|Drug|placebo to TA|110 ml saline iv
15883537|NCT03777683|Dietary Supplement|Dietary Supplement (OLIGOPIN)|investigators obtained ethical approval from the Research Ethics Committees of the Mashhad University of medical sciences. investigators enroll 60 patients who are admitted to ICU at hospitals of university. All eligible patients or their first degree relatives give informed consent before participating. Participants are randomly (block stratification) divided in two groups. At the first visit, baseline data are gathered and intervention group (n=30) will receive Oligopin supplement. In order to control the confounding effect of food intake, both the control and the intervention group receive the standard formulas based on their daily required energy via enteral root feeding.
15883538|NCT03777683|Other|Placebo|investigators obtained ethical approval from the Research Ethics Committees of the Mashhad University of medical sciences. investigators enroll 60 patients who are admitted to ICU at hospitals of university. All eligible patients or their first degree relatives give informed consent before participating. Participants are randomly (block stratification) divided in two groups. At the first visit, baseline data are gathered and control group (n=30) will receive oral capsules containing 130 mg Microcrystalline Cellulose. In order to control the confounding effect of food intake, both the control and the intervention group receive the standard formulas based on their daily required energy via enteral root feeding.
15883539|NCT03777670|Diagnostic Test|Blood test|Drop of blood for RNA and metabolic analysis
15883540|NCT03777657|Drug|Tislelizumab|200 mg IV on Day 1 during each 21-day cycle
15883541|NCT03777657|Drug|Placebo|Placebo to match zanubrutinib on Day 1 during each 21-day cycle
15883542|NCT03777657|Drug|Cisplatin|80 mg/m² IV on Day 1 during each 21-day cycle
15883543|NCT03777657|Drug|Oxaliplatin|130 mg/m² IV on Day 1 during each 21-day cycle
15883544|NCT03777657|Drug|Capecitabine|1000 mg/m² orally twice daily (BD) Days 1 through 14 (14 days total) during each 21-day cycle
15883545|NCT03777657|Drug|5-FU|800 mg/m²/day IV using continuous pumping system on Days 1 through 5 during each 21-day cycle
15883546|NCT03777644|Procedure|Continuous Paravertebral block with ropivacaine|"Inject local anesthetics in the T8 paravertebral space followed with catheter insertion and continuous local infusion.
~Device: Philip CX50 Ultrasound Scanner The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scanning
~Device: PAJUNK Contiplex S Catheter Drug: single dose ropivacaine 0.5%ropivacaine with 1:200,000 adrenaline, 25ml in total given immediately after the correct position of the tip of the needle has been confirmed Drug: continuously infusion of ropivacaine 0.2% ropivacaine, infusion rate: 0.125ml/kg/pulse,1pulse/h given through the catheter inserted in the T8 paravertebral space following the single dose Drug: Morphine given as IPCA bolus: 2mg, lock time: 5min, 1h limitation: 8mg"
15883547|NCT03777644|Procedure|Continuous Paravertebral Block with Saline|"Inject local anesthetics in the T8 paravertebral space followed with catheter insertion and continuous local infusion.
~Device: Philip CX50 Ultrasound Scanner The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scanning
~Device: PAJUNK Contiplex S Catheter Drug: single dose saline,25ml in total given immediately after the correct position of the tip of the needle has been confirmed Drug: continuously infusion of saline 0.9% saline, infusion rate: 0.125ml/kg/pulse,1pulse/h given through the catheter inserted in the T8 paravertebral space following the single dose"
15883548|NCT03777644|Drug|Patient-controlled analgesia with morphine|Drug: Morphine given as IPCA bolus: 2mg, lock time: 5min, 1h limitation: 8mg
15883549|NCT03777631|Procedure|Catheter ablation|CA should be performed within 1-6 months from the onset of cerebral infarction. CA is based on pulmonary vein isolation, with atrial ablation as required.
15883550|NCT03777618|Procedure|gluteal augmentation with flap in circumferential body lift|classic circumferential bodylift surgery, using two differents well-known flaps for gluteal augmentation
15883551|NCT03777605|Drug|Nitroglycerin 0.4 MG|"The study evaluate absorption rate of nitroglycerine 0.4 milligrams as tablets or a quickly absorbable capsuel NTG1523 determined by T-max and area under the response curve in the blood of NTG as well as from clinical effects.
~Data is entered on data sheet in anonymous form and processed. The results are presented in anonymous form by publication and lecture. Experts are given the supplement: The applicant's rights in a biomedical research project"
15883552|NCT03777592|Procedure|erector spinae plane block|local anesthetic or saline is administered in to the interfascial plane between the transverse process of the vertebra and the erector spinae muscles, spreading to multiple paravertebral spaces
15883553|NCT03777579|Drug|JS001，an engineered anti-PD-1 antibody|JS001 at a fixed dose of 240 milligrams via intravenous (IV) infusion on Days 1 of each 21-day cycle until disease progression or unacceptable toxicity.
15883554|NCT03777579|Drug|Nab-Paclitaxel|Nab-Paclitaxel at a starting dose of 125mg per square meter via IV infusion on Days 1, 8 of each 21-day cycle. Nab-Paclitaxel will be administered until disease progression or unacceptable toxicity.
15883555|NCT03777579|Drug|Placebo|Placebo administered via intravenous (IV) infusion on Days 1 of each 21-day cycle until disease progression or unacceptable toxicity.
15883556|NCT03777566|Diagnostic Test|sonohysterography|sonohysterography with measuring the uterine cavity volume
15883557|NCT03777553|Behavioral|Narrative Exposure Therapy for Justice-Involved Veterans|Behavioral intervention that uses narrative therapy and exposure to address repeated or complex trauma.
15883558|NCT03777540|Procedure|Gastric resection|"Partial gastrectomy with jejunal anastomosis, total gastrectomy, gastroenterostomy without gastrectomy or other (palliative surgery)."
15883559|NCT03777514|Drug|Ferumoxytol|treatment of iron deficiency anemia with IV iron.
15883560|NCT03777514|Drug|Ferrous sulfate|treatment of iron deficiency anemia with oral iron
15883561|NCT03777514|Other|Oral vitamin C|Oral vitamin C to be used as a placebo for participants receiving IV iron
15883562|NCT03777514|Other|Intravenous normal saline|Intravenous normal saline will be used as placebo for participants receiving oral iron
15883563|NCT03777501|Behavioral|non-random whole body vibration|Each participant will receive the treatment about one hour after the administration of medicine. For non-random whole body vibration group, participants will be required to maintain the erect standing position on the vibratory platform and the frequency and amplitude of vibratory stimuli will be 6Hz and 3mm respectively. Each treatment includes five sessions and each session is composed of one minute whole body vibration and one minute rest.
15883564|NCT03777501|Behavioral|occupational therapy|Participants will receive the occupational therapy including dynamic balance training and functional ambulatory training.
15883565|NCT03777488|Drug|Tranexamic Acid 1 gram intravenously|Intravenous tranexamic acid crossover to oral and intramuscular arms
15883566|NCT03777488|Drug|Tranexamic acid 2 grams oral solution|Oral tranexamic acid crossover to intravenous and intramuscular arms
15883567|NCT03777488|Drug|Tranexamic acid 1 gram intramuscular|Intramuscular tranexamic acid crossover to oral and intravenous arms
15883568|NCT03777475|Procedure|transarterial infusion|transarterial infusion
15883569|NCT03777462|Drug|Neoadjuvant gemcitabine plus nab-paclitaxel|Neoadjuvant gemcitabine plus nab-paclitaxel is used in the intervention group for 3 cycles. Standard doses of gemcitabine and nab-paclitaxel are adopted. Surgical resection will be performed after neoadjuvant chemotherapy.
15883570|NCT03777462|Drug|Neoadjuvant gemcitabine plus nab-paclitaxel with SBRT|Neoadjuvant gemcitabine plus nab-paclitaxel with SBRT is used in the intervention group for 3 cycles. Standard doses of gemcitabine and nab-paclitaxel are adopted. The radiation dose of SBRT is 7.5-8Gy/f for 5 fractions. Surgical resection will be performed 3 weeks after SBRT.
15883571|NCT03777462|Drug|Neoadjuvant S-1 plus nab-paclitaxel with SBRT|Neoadjuvant S-1 plus nab-paclitaxel with SBRT is used in the intervention group for 3 cycles. Standard doses of gemcitabine and nab-paclitaxel are adopted. The radiation dose of SBRT is 7.5-8Gy/f for 5 fractions. Surgical resection will be performed 3 weeks after SBRT.
15883572|NCT03777449|Radiation|CBCT|Patients will be taken a CBCT as a diagnostic tool to monitor peri-implant bone loss. This is a tool used on the daily basis for the evaluation of peri-implant bone loss. Patient will not be exposed to further radiation but the regular one.
15883573|NCT03777436|Drug|Apremilast|Oral
15883574|NCT03777436|Other|Placebo|Oral
15883575|NCT03777423|Device|PEEK framework partial dentures|Polymer-based framework recently introduced made of polyetheretherketone polymer frame combined with acrylic resin denture teeth and a conventional acrylic resin denture base.
15883576|NCT03777423|Device|Cobalt- chromium framework partial dentures|It's a bio-compatible metal used in thin sections so less bulky, provide high strength and stiffness ,conduct heat and cold for a more natural experience, enable designs that minimize the covering of the gingival margins, allow for a stable denture base, and resistance to corrosion.Drawbacks of metal frameworks can include hypersensitivity, aesthetics because of metal metal display, oral galvanism, adverse tissue reactions, osteolysis of abutment teeth, and biofilm production
15883577|NCT03777397|Other|Questionnaire|Questionnaire on the level of awareness of this risk among health sector employees, and more specifically the Lyon Civilian Hospices, and on participation in breast cancer screening for HCL employees, particularly among night shift staff.
15883578|NCT03777371|Other|Anti HIV Seropositive Pregnant Women|
15883579|NCT03777358|Device|3D-TVS|The 3D-TVS will be done by an experienced gynecological sonographer. The uterine cavity will be assessed by obtaining a mid-coronal view. Then hysteroscopy will be performed
15883580|NCT03777345|Device|cobalt-chromium framework partial dentures|It's a biocompatible metal alloy used in thin sections and are less bulky, provide high strength and stiffness ,conduct heat and cold for a more natural experience, enable designs that minimize the covering of the gingival margins, allow for a stable denture base, and is resistant to corrosion. Disadvantages include hypersensitivity, esthetic issues with metal display, oral galvanism, adverse tissue reactions, osteolysis of abutment teeth, and biofilm production .
15883581|NCT03777345|Device|PEEK framework partial dentures|It's a promising polymer-based framework material has recently been introduced which is made of polyetheretherketone polymer frame combined with acrylic resin denture teeth and a conventional acrylic resin denture base.
15883582|NCT03777332|Drug|APL-2|Complement (C3) Inhibitor
15883645|NCT03776786|Biological|TY014|TY014 Injection, (100 mg/5 mL/Vial), Yellow Fever Virus (YFV) Monoclonal Antibody (mAb)
15883646|NCT03776786|Other|0.9% Saline|Placebo
15893421|NCT03701282|Other|Quality-of-Life Assessment|Ancillary studies
15883587|NCT03777293|Device|ultrasound viscoelasticity|use these devices to do ultrasound examination in chronic liver disease patients
15883588|NCT03777280|Device|peek framework RPD|it is a polyetheretherketone polymer frame combined with acrylic resin denture teeth and a conventional acrylic resin denture base made by injecting technique and have several advantages regarding strength and esthetics
15883589|NCT03777280|Device|cobalt chromium framework RPD|standard framework device
15883590|NCT03777267|Device|Active CR|The upgraded platform for medical research using the HIRREM technology has been rebranded as Cereset Research® (CR). This system uses the same core technology and algorithms to echo brainwaves in real-time using audible tones, as with HIRREM. The CR system also includes 64-bit processing architecture for faster feedback, the use of 4 sensors, and the use of standard protocols (with flexibility regarding the length and sequencing of the standard protocols), all done with eyes closed. Four sensors are applied to the scalp at a time. However, only two sensors are actively echoing feedback. The software automatically switches from one sensor pair to the other when needed. This reduces the number of sensor placement changes needed, resulting in shorter session time and fewer interruptions.
15883591|NCT03777254|Biological|RC28-E|RC28-E intravitreous injection 50ul
15883592|NCT03777241|Behavioral|Behavioral Intervention Team|Multidisciplinary team to assist with actively identifying and managing mental illness and substance abuse disorders at their earliest possible time during hospitalization.
15883593|NCT03777241|Behavioral|Standard of care|Participants in this group will receive standard of care.
15883594|NCT03777215|Drug|Angiotensin-(1-7)|This is a biologically active beneficial hormone of the renin-angiotensin system.
15883595|NCT03777215|Drug|Saline|Saline will be used as the placebo comparator.
15883596|NCT03777202|Procedure|High-flow nasal oxygen|High-flow nasal oxygen will be applied to the patients using Optiflow system through nasal openings during sleep endoscopy. Pulse oximetry will be monitored continuously. Otorhinolaryngologist will observe the degree of upper airway obstruction during sleep endoscopy.
15883597|NCT03777202|Procedure|Low-flow nasal oxygen|Low-flow nasal oxygen will be applied to the patients through nasal openings using conventional nasal cannula during sleep endoscopy. Pulse oximetry will be monitored continuously. Otorhinolaryngologist will observe the degree of upper airway obstruction during sleep endoscopy.
15883598|NCT03777189|Behavioral|Cognitive-Behavioral Therapy|Cognitive-behavioral therapy will be delivered in line with recommendations (e.g., NICE 2017). Format will be guided self help with added content related to physical activity.
15883599|NCT03777176|Drug|dasiglucagon|Glucagon analog
15883600|NCT03777176|Other|Standard of Care|Standard of care according to site and/or country
15883601|NCT03777163|Biological|Butantan Institute Trivalent Seasonal Influenza Vaccine|Butantan Institute and Pasteur-Mérieux (present, Sanofi Pasteur) established a technology transfer in 1999 for the production of a trivalent influenza vaccine of inactivated split-virion using embryonated eggs. The technology transfer followed a progressive approach from importing the finished product, to packaging and quality control test for release (1999), and, finally, to the first batch of influenza vaccine entirely produced by Butantan (2011). In 2013, the Butantan vaccine was registered by the Brazilian National Agency of Sanitary Surveillance (ANVISA).
15883602|NCT03777163|Biological|Sanofi Trivalent Seasonal Influenza Vaccine|VAXIGRIP® was launched in 1968 and since then has been licensed in more than 100 countries and prequalified by WHO in 2011. Several clinical studies by Sanofi Pasteur have examined the safety and immunogenicity of Vaxigrip® in older children (8-10 years), adults (18-59 years), elderly (> 60 years),11,12 children (six months to three years) 13 and pregnant women.
15883603|NCT03777150|Other|Postoperative care in Intensive care unit (ICU)|Postoperative care in Intensive care unit (ICU)
15883604|NCT03777150|Other|Postoperative care in standard ward|Postoperative care in standard ward
15883605|NCT03777137|Behavioral|TMS (Rapid2, Magstim Corp)|Volunteers will take a telephone screening questionnaire and those meeting inclusion criteria will attend their first visit. Those signing the consent will have a T1 weighted MRI scan to localize sites in the brain to be stimulated with TMS. The subjects will then have four visits at intervals of two weeks; each visit will have a TMS intervention including SITE1, SITE2, SITE3, and SITE4. The sequence of the testing TMS four different visits (SITE1 to SITE4) will be randomly assigned among stimulation sites Medial Frontal (MF), Dorsal Lateral Frontal (DL), Primary motor cortex (M1) and Interparietal Sulcus (Sham) and counterbalanced across subjects (see Diagram below). During each of visits 2 to 5, each participant will undergo baseline Quantitative Sensory Testing (QST), followed by a TMS intervention, and then by repeat QST. QST will consist of pain thresholds for contact heat.
15883606|NCT03777124|Drug|SHR-1210|Subjects receive SHR-1210 intravenous every 2 weeks
15883607|NCT03777124|Drug|Apatinib|Subjects receive Apatinib orally every day
15883608|NCT03777124|Drug|Pemetrexed|Subjects receive Pemetrexed intravenous every 3 weeks
15883609|NCT03777124|Drug|Carboplatin|subjects receive carboplatin intravenous every 3 weeks
15883610|NCT03777111|Other|Exercise|Single Task Training: Single task training includes exercises that require only one task or stimulation. For this study the task consists of motor tasks (walking or balance) Dual Task Training: Dual task training includes exercises simultaneous performance of two tasks that can be performed independently, measured separately and with different goals. In the study motor tasks will combine with cognitive tasks.
15883690|NCT03776487|Drug|Oxaliplatin|Given IV
15883691|NCT03776487|Procedure|Therapeutic Conventional Surgery|Undergo partial or total gastrectomy and lymphadenectomy
15883611|NCT03777098|Device|Strepic® Device|The Strepic® device is a qualitative point-of-care diagnostic test for the detection of GAS pharyngitis. The test uses direct visualization of the pharynx with a light source of specified wavelengths, causing excitation of endogenous fluorophores that emit a characteristic colored light pattern. White light images may give additional diagnostic accuracy through use of an artificial intelligence analysis of a large set of images of GAS and non-GAS pharyngitis.
15883612|NCT03777085|Drug|TQB2303|375mg/m2, iv q3w,6 cycles(each cycle is 3 weeks
15883613|NCT03777085|Drug|Rituximab|375mg/m2, iv q3w,6 cycles(each cycle is 3 weeks
15883614|NCT03777059|Drug|Atogepant|Atogepant tablet
15883615|NCT03777059|Drug|Placebo|Placebo-matching atogepant tablets
15883616|NCT03777046|Behavioral|Standard of Care (SOC)|Mothers that meet inclusion criteria for the study, that score 10 or more on the Edinburgh Postpartum Depression Scale (EPDS) that will receive Standard of care treatment. SOC treatment includes social work consult with information about follow up options for PPD.
15883617|NCT03777046|Behavioral|SOC with Psychology Therapy (CBT)|Mothers that meet inclusion criteria for the study, that score 10 or more on the Edinburgh Postpartum Depression Scale (EPDS) that will receive the experimental intervention. Intervention includes SOC treatment as well as psychology therapy (CBT) in the hospital.
15883618|NCT03777033|Drug|Prophylactic protocol with Ca and Vit D|"3g calcium /day for 5 days and then 2g/day for 10 days 2 Micrograms Alfacalcidol/day and then 1 microgram /day for 10 days
~the Prophylactic protocol with Ca and Vit D will be given in the form of Alfacalcidol 0.5 Micrograms Capsule and CALCIUM CARBONATE + CALCIUM GALACTOGLUCONATE 1000mg tablet"
15883619|NCT03777020|Behavioral|Service Dog Training Program|Participate in 8 weekly dog training sessions using a positive reinforcement method and curriculum under the direct supervision of trainer at the Warrior Canine Connection facility in Boyds (Montgomery County) MD.
15883620|NCT03777020|Other|Dog Training Education|Learn about training dogs by watching 8 weekly dog training online modules programs at the Warrior Canine Connection facility in Boyds (Montgomery County) MD. After completing this education the participants will participate in the service dog training program.
15883621|NCT03777007|Device|SPARTA force plate|The Sparta Platform includes force plate hardware coupled with Sparta Scan software that enables quick assessment of an individual's movement and balance within minutes
15883622|NCT03776994|Biological|Vaccinations on Day 0, Day 28, and Day 140|The monovalent VEE VLP vaccine (the same VEE VLP study agent which comprises the VEE portion of the NIAID trivalent alphaviral VLP vaccine) will use the same vaccination regimen (Day 0, Week 4 [Day 28], and Week 20 [Day 140]) and the vaccine dosages (2 μg, 10 μg, and 20 μg)
15883623|NCT03776981|Other|Core Activation|Volitional activation of the transversus abdominis muscle during self-selected paced ambulation for both groups.
15883624|NCT03776981|Other|Core Stabilization|Six-week core stabilization program for the group of participants with knee osteoarthritis.
15883625|NCT03776968|Drug|HC1119|oral
15883626|NCT03776955|Drug|Carvedilol|Oral tablet
15883627|NCT03776929|Behavioral|Dialectical Behavioral Therapy|Dialectical Behavior Therapy (DBT) is a cognitive behavioral therapy that focuses on the balance between change and acceptance. DBT skills include four modules: two that enforce acceptance-oriented skills, mindfulness and distress tolerance, and two that promote change-oriented skills, interpersonal effectiveness and emotional regulation.
15883628|NCT03776916|Other|Simethicone administration 20-30 min before the procedure|Patients intake simethicone 20-30 min before the procedure
15883629|NCT03776916|Other|Simethicone administration 31-60 min before the procedure|Patients intake simethicone administration 31-60 min before the procedure.
15883630|NCT03776916|Other|Simethicone administration > 60 min before the procedure|Patients intake simethicone administration > 60 min before the procedure.
15883631|NCT03776903|Other|ZIKV Detect™ 2.0 IgM Capture ELISA|De-identified archive specimens are tested by ELISA and compared to reference testing (RT-PCR and CDC MAC-ELISA)
15883632|NCT03776890|Behavioral|DeStress for Health Program|The program will consist of 4 in person sessions that are based on empirically supported Positive Psychosocial Well-Being PPWB components including Optimism, Mindfulness, Positive Reprisal as well as Strengths-based Cognitive Behavioral Therapy (SBCBT) to improve behavioral self-regulation towards health-related goals. Research staff will conduct face-to-face surveys with participants at baseline and at end of program. Finally, we will conduct a phone-based survey 30 days after program completion to assess sustainability of intervention effects.
15883633|NCT03776864|Biological|Pembrolizumab|Given IV
15883634|NCT03776864|Drug|Umbralisib|Given PO
15883635|NCT03776851|Drug|erythropoietin|erythropoietin 50 International Units (IU) per kilogram three times weekly by subcutaneous route
15883636|NCT03776838|Drug|Intravenous Fentanyl guided by SoC+NOL|Predeterminated bolus of IV Fentanyl will be given at the induction of anesthesia (2 mcg/kg), at the time of incision (1 mcg/kg). During surgery, administration of 0.5 mcg/kg of IV Fentanyl will be administred following a pre determinated algorithm based on NOL index + heart rate + mean arterial blood pressure variations.
15883637|NCT03776838|Drug|Intravenous Fentanyl guided by SoC|Bolus of IV Fentanyl at the discretion of a physician will be given at the induction of anesthesia, and at the time of incision. During surgery, administration of IV Fentanyl at the discretion of a physician will be administred following a pre determinated algorithm based on heart rate + mean arterial blood pressure variations.
15883638|NCT03776825|Device|Permacol Paste|Permacol Paste Injection
15883639|NCT03776812|Drug|Relacorilant, 100mg QD|Relacorilant is supplied as capsules for oral dosing
15883640|NCT03776812|Drug|Nab-paclitaxel, 80mg/m^2|Nab-paclitaxel is administered as IV infusion over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle
15883641|NCT03776812|Drug|Nab-paclitaxel, 100mg/m^2|Nab-paclitaxel is administered as IV infusion over 30-40 minutes on Days 1, 8, and 15 of each 28-day cycle
15883642|NCT03776812|Drug|Relacorilant, 150mg QD|Relacorilant is supplied as capsules for oral dosing
15883643|NCT03776799|Device|Stent-avoiding|Percutaneous transluminal angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries
15883644|NCT03776799|Device|Stent-based|Stenting, in which a stent is advanced and implanted in the obstructed artery, has become the standard endovascular treatment for peripheral arteries
15893422|NCT03701282|Drug|Venetoclax|Given PO
15883647|NCT03776773|Other|Pollution exposure|Pollution exposure and sleep data will be recorded by pollution sensor and polysomnography respectively. In order to compare the variations according to the pollinisation season and the allergic rhinitis status of the patients.
15883648|NCT03776760|Device|Fingerstick GeneXpert HCV RNA quantitative assay|All participants at risk of HCV infection will receive HCV RNA testing using the GeneXpert finger-stick point-of-care HCV quantitative assay 6 monthly
15883649|NCT03776760|Drug|sofosbuvir/velpatesvir|Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia
15883650|NCT03776760|Drug|glecaprevir/pibrentasvir|Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia
15883651|NCT03776747|Drug|Prone hyperpolarized 3 helium gas scan|Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is prone.
15883652|NCT03776747|Drug|Supine hyperpolarized 3 helium gas scan|Hyperpolarized gas used as a contrast agent to test reproducibility of MRI of the lungs/Images done while subject is supine.
15883653|NCT03776747|Diagnostic Test|Vitals|
15883654|NCT03776747|Diagnostic Test|Pulmonary Function Tests|Pre and post spirometry, diffuse lung carbon monoxide (DLCO), lung volumes
15883655|NCT03776747|Diagnostic Test|Initial protocol MRI scan|Initial scan to determine placement
15883656|NCT03776734|Other|Cryotherapy application|Effects of 5-10- 20 minutes cold application on quadriceps muscle
15883657|NCT03776721|Procedure|Liposuction|Liposuction is performed on the abdomen or thighs.
15883658|NCT03776721|Procedure|Fat graft|30mL harvested lipoaspirate is injected at the affected axillary site.
15883659|NCT03776721|Procedure|Sham graf (Saline injection)|30mL saline is injected at the affected axillary site.
15883660|NCT03776721|Biological|Stem cell injection|4mL stem cell suspension injected at the affected axillary site.
15883661|NCT03776721|Procedure|Saline injection|4mL saline injected at the affected axillary site.
15883662|NCT03776708|Other|Spinal manipulation|Spinal manipulation is defined as a quick, passive and forced manoeuvre applied to spinal joints, and sometimes followed by a characteristic cracking sound. It can be compared to a mobilisation, which is a passive manual therapy as well, but is applied slower and repetitively on the joints. Spinal manipulation has been shown to have a significant clinical impact in the treatment of musculoskeletal pain
15883663|NCT03776708|Other|Sham procedure|"The sham procedure is a manual contact on both inferior angles of the scapulae by the chiropractor. After a short tensioning, a slight movement with low velocity and low amplitude is done, respecting scapula-thoracic sliding plans laterally, without repercussion on the spine. It is considered by us to be a credible sham procedure, as it resembles an actual act of thoracic manipulation, and it has been validated, with questionnaires"
15883664|NCT03776695|Biological|Tyzivumab|Tyzivumab Injection, (100 mg/5 mL/Vial), Zika Virus (ZIKV) Monoclonal Antibody (mAb)
15883665|NCT03776695|Other|Placebo|0.9% Saline
15883666|NCT03776669|Procedure|Laparoscopic sleeve gastrectomy + Hiatal hernia repair|To evaluate the role of concomitant hiatal hernia repair in laparoscopic sleeve gastrectomy for morbidly obese patients.
15883667|NCT03776669|Procedure|Laparoscopic sleeve gastrectomy alone|Current mainstay and standard surgical treatment for morbidly obese patients.
15883668|NCT03776656|Drug|Allopurinol|Daily oral administration
15883669|NCT03776643|Drug|ILT-101 ld-(IL2)|Subcutaneous injections of ILT-101 or Placebo starting with once-daily administration for 5 consecutive days followed by once every two weeks administration during five months
15883671|NCT03776617|Procedure|scalp block|Scalp block will be performed five minutes before head pinning for elective craniotomy by blocking supraorbital, auriculotemporal, occipital and postauricular branches of the greater auricular nerves.
15883672|NCT03776604|Drug|PEG-rhG-CSF|"Subjects with newly diagnosed small cell lung cancer who met the inclusion/exclusion criteria were prophylactically administered the test drug PEG-rhG-CSF 48 h after chemotherapy.
~Jin Youli（PEG-rhG-CSF）: The dose is determined according to the patient's weight. Those who weighed more than ≥45kg were given 6mg/time, and those who were <45kg or less were given 3mg/time. Administration method: Subcutaneous injection, the lower edge of the deltoid muscle of both arms is preferentially selected, and each injection is injected once every chemotherapy cycle.
~Dosing time: 48 h after chemotherapy."
15883673|NCT03776591|Procedure|Open surgery|
15883674|NCT03776591|Procedure|Right colectomy|
15883675|NCT03776591|Procedure|Laparoscopic surgery|
15883676|NCT03776591|Procedure|Central lymphadenectomy and vascular ligation|
15883677|NCT03776578|Procedure|swallow fuction and swallow training|nasogastric tube dependence rate
15883678|NCT03776565|Other|Ultrasound|Ultrasound of antrum of stomach
15883679|NCT03776552|Other|Low energy diet (LED)|LED for 8 weeks
15883680|NCT03776552|Other|Gradual weight loss (GWL)|Moderate energy restriction
15883681|NCT03776539|Drug|ELX-02|ELX-02 is a synthetic, designer eukaryotic ribosomal specific glycoside (ERSG) optimized as a translational read-through drug. All groups will get the same treatment.
15883682|NCT03776526|Behavioral|Fitbit® Alta HR Sleep monitoring|Patients will be fitted with a Fitbit® Alta HR after surgery, which will monitor sleep quality (sleep duration and number of awakenings) for the duration of hospitalization.
15883683|NCT03776513|Behavioral|an MRI examination|The MRI examination implies the realization of an emotional associative memory task
15883684|NCT03776500|Drug|PBTZ169|PBTZ169 crystalline supplied as powder for oral solution
15883685|NCT03776500|Drug|Placebo|matching placebo supplied as powder for oral solution
15883686|NCT03776487|Drug|Fluorouracil|Given IV
15883687|NCT03776487|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
15883688|NCT03776487|Biological|Ipilimumab|Given IV
15883689|NCT03776487|Biological|Nivolumab|Given IV
15883692|NCT03776474|Biological|Blood collection|Patients less than 5 kg : 2 ml Patients over 5 kg : 3 ml Patients over 10 kg : 5 ml
15883693|NCT03776461|Device|Venus Viva|The Venus Viva™ is a non-invasive medical aesthetic device, intended for use in dermatologic and general surgical procedures, requiring ablation and resurfacing of the skin, using the Viva applicator.
15883694|NCT03776448|Dietary Supplement|Sativa Nigra oil Softgels|Nigella sativa, a flowering plant native to southwest Asia, is considered one of the most important healing medicinal plants in Islamic culture. The use of its richly colored black seeds has been recommended in the prophetic medicine. It's also known by various other names amongst different cultures. Importantly, its seed is known in Arabic as 'habat al Baraka' which translates literally to 'the seed of blessing'.The active ingredient is believed to be thymoquinone richly present in the oil extract of its seeds. Apart from mild occasional gastrointestinal disturbance, black seed oil has no side effects and is considered very safe. .
15883695|NCT03776448|Dietary Supplement|Activated Charcoal Softgels|This supplement is manufactured by [Arkopharma Pharmaceutical Laboratories] and is available commercially. The use of activated charcoal softgels as a placebo is documented in several other clinical trials. The single most relevant characteristic of charcoal is its minimal if any gastrointestinal absorption. As a result, it does not undergo any metabolism and is excreted completely in feces. This makes charcoal an attractive placebo choice for small trials or when manufacturing a specific placebo is not feasible. Charcoal softgels are black in color and resemble black seed oil softgels to a great extent.
15883696|NCT03776435|Radiation|Abdomen CT|Patients are divided into CT-exposed or unexposed group according to the presence of claims codes of abdominopelvic CT conducted within seven days before and after appendectomy. The seven-day threshold is arbitrarily determined considering the delay in the diagnosis of appendicitis and the postoperative examination for surgical complication.
15883697|NCT03776422|Behavioral|Mobile self-help intervention|Participants receive several apps on their phone including IntelliCare apps, which are based on principles of cognitive-behavioral therapy. Participants also receive the Pocket Helper app, which has been designed for this study. The tools within the Pocket Helper app include a crisis text line that is available 24/7, the Illinois Warm Line which is available Monday through Friday from 8am to 5pm, directions to call 911 in the case of an emergency, the Koko web app that provides crowdsourced emotional support, brief cognitive-behavioral interventions, daily tips, and daily surveys. Phones will also include the StreetLight Chicago app, which provides homeless individuals with up-to-date information on shelters, health clinics, emergency contacts, mental health services, and more.
15883698|NCT03776409|Drug|vancomycin plus piperacillin/tazobactam|Patients in intensive care unit who received the combination of VAN(vancomycin) and PTZ (piperacillin/tazobactam) for at least 48 hours, had a serum creatinine level measured in the 24-hour of hospital admission.The dosage and frequency of VAN and PTZ was adjusted based on clinical practice and patient characteristics.
15883699|NCT03776409|Drug|vancomycin plus other beta-lactams|Patients in intensive care unit who received the combination of VAN (vancomycin) and other beta-lactams (cefoperazone/sulbactam, meropenem, imipenem/siastatin, ceftriaxone, ceftazidime, et al) for at least 48 hours, had a baseline serum creatinine (Scr) concentration value within 24 hours of hospital admission.The dosage and frequency of VAN and other beta-lactams were adjusted based on clinical practice and patient characteristics.
15883700|NCT03776383|Other|Antibiotic use feedback letter|Mailed letters indicating that the physician prescribes more antibiotics than 75% of their peers
15883701|NCT03776370|Procedure|Preserve the left colonic artery|Preservation of left colonic artery in rectal cancer surgery.
15883702|NCT03776370|Procedure|The left colonic artery is not preserved|The left colonic artery was dissected in rectal cancer surgery.
15883703|NCT03776357|Device|VERA clinic|A software system used with the Microsoft Kinect intended to support the physical rehabilitation of adults in the clinic and at home.
15883704|NCT03776344|Device|Virtual Reality intervention - Oculus Rift HD|During the VR experience patients will have the opportunity to choose from different VR environments (VR application - Nature Treks VR) and explore them using Oculus Rift Device.
15883705|NCT03776331|Diagnostic Test|Flow mediated dilation|Measurement of the change in the vasodilatative reserve of the brachial artery
15883706|NCT03776318|Drug|Long-Term Safety Follow-up|STX-015-18-01 long-term safety follow-up
15883707|NCT03776305|Drug|Imipenem|1-h infusion of 0.5 g of imipenem diluted in 100 mL of normal saline solution, delivered via infusion pump at a constant flow rate, every 6 h. The imipenem PK studies were carried out during administration of the fourth dose of each regimen (18-24 h after the start of the regimen). Blood samples were obtained by direct venipuncture at the following times: before (time zero) and 0.25, 0.5, 0.75, 1, 2, 3, 4, 5 and 6 h after the fourth dose of each regimen.
15883708|NCT03776292|Other|monitoring|Primary outcome; composite 1ry outcome [1-Dynamic pulmonary compliance monitoring.2- Cardiac Index monitoring] during and after surgical retractor application compared to the same variables reading prior retractor application and in between both groups. Secondary outcome: Static lung compliance, Cardiac output, Stroke volume SV - stroke volume variability (SVV)-Cardiac performance index, O2 delivery DIO2. Noninvasive Intraoperative hemodynamic (MBP, HR, O2 saturation)] during and after surgical ring retractor application compared to the same variable reading prior retractor application and in between both groups.
15883709|NCT03776279|Drug|Mitoxantrone Hydrochloride Liposome Injection|Mitoxantrone Hydrochloride Liposome Injection 20 mg/m2 will be infused intravenously once over 60min in 250 ml 5％ glucose injection on the first day during a treatment phase of 4 weeks.
15883710|NCT03776266|Procedure|No intervention is required due to retrospective observational study|Red blood cell transfusion on or after percutaneous coronary intervention
15883711|NCT03776253|Behavioral|Psychosocial Care Conquer Fear Support intervention (psychoeducation, attention training, worry management, and detached mindfulness components)|Attend CFS
15883712|NCT03776253|Other|Questionnaire Administration|Ancillary studies
15883713|NCT03776240|Drug|HD201|Single-dose 6mg/kg body weight by 90 minute intravenous infusion
15883714|NCT03776240|Drug|EU-Herceptin|Single-dose 6mg/kg body weight by 90 minute intravenous infusion
15883715|NCT03776240|Drug|US-Herceptin|Single-dose 6mg/kg body weight by 90 minute intravenous infusion
15883716|NCT03776227|Drug|sotagliflozin (SAR439954)|"Pharmaceutical form: tablet
~Route of administration: oral"
15883799|NCT03775590|Procedure|Acetic acid|To evaluate using water + vinegar in the treatment of atopic dermatitis
15883717|NCT03776201|Other|Balance Training|We expect that a balance training intervention that utilizes an external focus of attention will lead to the adoption of balance strategies that are protective against falls. The mechanism for this behavioral change will be identified using a Dynamical Systems Theory framework (i.e., entropy) to quantify postural sway characteristics before, during and after the training. We will determine whether the balance intervention utilizing an external focus of attention will lead to positive benefits through the three specific aims.
15883718|NCT03776175|Drug|PF-05221304 Monotherapy|Participants enrolled in this Arm will receive 15 mg dose of PF-05221304 (3 tablets of 5 mg each) and 3 tablets of Placebo for PF-06865571, each to be taken twice daily for 41 days and once on Day 42.
15883719|NCT03776175|Drug|PF-06865571 Monotherapy|Participants enrolled in this Arm will receive 300 mg dose of PF-06865571 (3 tablets of 100 mg each) and 3 tablets of Placebo for PF-05221304, all to be taken twice daily for 41 days and once on Day 42.
15883720|NCT03776175|Drug|Placebo|Participants enrolled in this Arm will receive 3 tablets for Placebo of PF-05221304 and 3 tablets of Placebo of PF-06865571, to be taken twice daily for 41 days and once on Day 42.
15883721|NCT03776175|Drug|PF-05221304 and PF-06865571 Combination|Participants enrolled in this Arm will receive 15 mg dose of PF-05221304 (3 tablets of 5 mg each) and 3 tablets of PF-06865571 (3 tablets of 100 mg each), each to be taken twice daily for 41 days and once on Day 42.
15883722|NCT03776162|Procedure|ACL Reconstruction (Bone Patellar Tendon Bone Graft)|Standard of care procedure Patellar Tendon Autograft ACL reconstruction, in which a bone-patellar tendon-bone graft from the front of the knee is taken to replace the torn ACL.
15883723|NCT03776162|Device|Bridge Enhanced ACL Repair (BEAR)|The BEAR technique involves surgically placing a sponge (the BEAR scaffold) between the torn ends of the ACL, providing a scaffold for the ligament ends to group into.
15883724|NCT03776149|Dietary Supplement|Beetroot juice|Following randomization on day 1, subjects will consume either the nitrate or nitrate-free beverage for 7 days with outcome measurements performed on day 7. Following a 7 day washout, subjects will then consume the crossover beverage for 7 days with outcome measures performed on day 21.
15883725|NCT03776149|Dietary Supplement|Black currant juice|Following randomization on day 1, subjects will consume either the nitrate or nitrate-free beverage for 7 days with outcome measurements performed on day 7. Following a 7 day washout, subjects will then consume the crossover beverage for 7 days with outcome measures performed on day 21.
15883726|NCT03776136|Drug|lenvatinib|Administered orally once a day during each 21-day cycle.
15883727|NCT03776136|Biological|pembrolizumab|Administered as an IV infusion on Day 1 Q3W.
15883728|NCT03776110|Drug|GRT9906 PR tablet|40 mg GRT9906 PR tablet oral (minimal release of 80 percent after 480 minutes)
15883729|NCT03776110|Drug|Placebo|Placebo tablet matching 40 mg GRT9906 PR tablet
15883730|NCT03776097|Other|observational study|Observational study
15883731|NCT03776084|Device|Continuous Positive Airway Pressure|CPAP indication
15883736|NCT03776058|Drug|Cinacalcet|Tablets for oral administration
15883737|NCT03776058|Drug|Placebo|Tablets for oral administration
15883738|NCT03776045|Other|Standard care plus exercise|The exercise was supervised by exercise science staff in the exercise science facilities at the University of East Anglia, UK. Participants competed two weekly sessions for 12 weeks upon initiating ADT. Each session lasted ~60 min and included aerobic interval exercise on a cycle ergometer (Monark 824E; Varberg, Sweden) followed by resistance training. In addition to the supervised exercise sessions, patients were advised on how to increase their habitual physical activity levels and were encouraged to engage in 30 minutes of self-directed exercise on three days each week (e.g. brisk walking, cycling, home-based resistance training).
15883739|NCT03776032|Drug|Darbepoetin alfa|Administered by subcutaneous injection once a week
15883740|NCT03776032|Drug|Placebo|Placebo matching to darbopoetin alfa administered by subcutaneous injection once a week.
15883741|NCT03776019|Device|AVWF device|The AVWF method utilizes sound modulated music, which is thought to regulate the vagus nerve.
15883742|NCT03776006|Procedure|Transperineal Laser Ablation|Transperineal Laser Ablation of the Prostate
15883743|NCT03775993|Drug|Human growth hormone|Administration of growth hormone
15883744|NCT03775993|Other|Placebo|Administration of placebo
15883745|NCT03775980|Device|Emprint Microwave Ablation System|Microwave Ablation of colorectal liver metastases
15883746|NCT03775967|Diagnostic Test|sialic acid|sialic acid level estimation in salivary samples
15883747|NCT03775967|Diagnostic Test|IL10|IL10 estimation in salivary samples
15883748|NCT03775954|Diagnostic Test|Fetal Magnetocardiogram and Neonatal Electrocardiogram|Fetal Magnetocardiography (fMCG) is a new non-invasive diagnostic procedure that records tiny fetal cardiac signals similar to an Electrocardiogram or Holter monitor. The magnetometer has FDA clearance, and does not emit magnetic, electric or other energies. This is not an MRI. Examples of fetal MCG's can be found in the Links. The American Heart Association Scientific Statement on Fetal Diagnosis and Treatment (Circulation, 2014) has declared fMCG to be Class IIa for fetal heart rhythm abnormalities, meaning that benefit far exceeds risk. As part of this study, a neonatal electrocardiogram (nECG) will be obtained for comparison after the baby is born.
15883749|NCT03775928|Drug|Apatinib|apatinib 425mg qd po
15883750|NCT03775928|Drug|capecitabine|capecitabine 1000mg/m2 bid d1-d14
15883751|NCT03775915|Other|Neurofeedback|A visual representation of the participants brain activity during movement of their affected hand in the MRI scanner.
15883752|NCT03775915|Other|Sham Neurofeedback|A visual representation of brain activity pre-recorded from a previous participant
15883753|NCT03775902|Drug|Placebo, Nicorandil, Glimepiride|On three separate experimental days, one of the two drugs or placebo is administered in tablet form.
15883754|NCT03775889|Behavioral|Gardening|Assist with planting and maintaining the school garden, as well as observe the school garden curriculum and dietary assessment protocols
15883755|NCT03775876|Procedure|Shoulder Arthroscopy|patients in both groups are programmed for an elective shoulder arthroscopy surgery
15883874|NCT03775031|Device|Fractional Laser and Chemical Peel|Fractional 1927 nm Laser, Fractional 1550 nm Laser, and 25% TCA (trichloroacetic acid) peel
15883756|NCT03775876|Procedure|Regional Block|patients in both groups received regional block for anesthesia: brachial plexus blockade was performed using the interscalene approach under ultrasound combined to nerve stimulation. 20 ml ropivacaine 0.375% were injected.
15883757|NCT03775876|Drug|Propofol|propofol 10mg/ml was used for sedation as described in the arms section
15883758|NCT03775876|Drug|Dexmedetomidine|Dexmedetomidine was diluted to 4mcg/ml and used for sedation as described in the arms section
15883759|NCT03775876|Diagnostic Test|BIS|sedation level was monitored using bispectral index to achieve values described in the arms group
15883760|NCT03775863|Procedure|Liver transplantation|Liver transplantation for patients with hepatocellular carcinoma
15883761|NCT03775850|Biological|EDP1503|4 capsules taken by mouth twice daily. Each capsule will contain ≥ 7.5x10^10 colony-forming units (CFU)
15883762|NCT03775850|Biological|Pembrolizumab|200 mg given by intravenous (IV) infusion once every 3 weeks
15883763|NCT03775837|Dietary Supplement|Panax Ginseng C.A. Mey Extract group|This group takes Panax Ginseng C.A. Mey Extract for 8 weeks
15883764|NCT03775837|Dietary Supplement|Placebo group|This group takes placebo for 8 weeks
15883765|NCT03775824|Drug|MTX start|Patient prescribed MTX s.c. or p.o. because of active rheumatoid arthritis
15883766|NCT03775824|Drug|TNF start|Patient prescribed TNF-inhibitor because of active rheumatoid arthritis
15883767|NCT03775811|Other|Computer-assisted histological prediction of colon polyps|The objective is to validate in real clinical practice an improved version of our computer histological prediction system
15883768|NCT03775798|Drug|Direct antiviral agents for hepatitis C|Direct-acting antivirals for hepatitis C
15883769|NCT03775785|Dietary Supplement|Tailored enteral nutrition|"The mean of three measurements per batch (3 x 2-3ml) will be used to calculate the required amount of extra fat, protein, and carbohydrate for the following 3 days of fortification using a predefined Excel spread sheet (Microsoft Inc, Redmond, Washington).
~The intervention will consist of adding fat, protein, and/or carbohydrate to achieve target levels of macronutrients.
~The defined macronutrient concentration in breast milk is 4.4 g/100 mL of fat, 3 g/100 mL of protein, and 8.8 g/ 100 mL of carbohydrate to meet the European Society for Paediatric Gastroenterology, Hepatology, and Nutrition (ESPGHAN) guidelines (6.6 g/kg/d of fat, 4.5 g/kg/d of protein, and 13.2 g/kg/d of carbohydrate) assuming an intake of 150 mL/kg/d."
15883770|NCT03775772|Procedure|Oral Health|"test group will receive an dental hygiene program for one year
~control group will remain with dental hygiene regime like done before study participation (maximum of two dental hygiene Treatments per year)"
15883771|NCT03775772|Procedure|Bite Force|"test group will receive physiotherapy with the aim of increasing muscle strength in chewing muscles for 3 months
~control group will remain without such training"
15883772|NCT03775759|Procedure|Tricuspid valve repair or replacement|Available rings used at Duke include the Tri-Ad™ Adams Tricuspid Ring by Medtronic, the TAILOR™ FLEXIBLE ANNULOPLASTY RING by St. Jude Medical/Abbott, and the Carpentier-Edwards Physio II Ring by Edwards LifeSciences. Available valves used at Duke include the Mosaic™ Mitral Orbutrator by Medtronic, the Carpentier-Edwardes PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis by Edwards LifeSciences, the On-X Mitral Valve, by CryoLife, the Carbomedics Prosthetic Heart Valve by LivaNova, and the St. Jude Medical™ Mechanical Heart Valve by St. Jude Medical/Abbott.
15883773|NCT03775759|Other|Medical management of tricuspid regurgitation|The medical therapy involved includes inotropic medications and diuretic medications, which are standard of care for patients in this population.
15883774|NCT03775746|Drug|Clopidogrel 75Mg Tablet|Prevention of atherothrombotic events in percutaneous coronary intervention (adjunct with aspirin) in patients not already on clopidogrel
15883775|NCT03775746|Drug|Rivaroxaban 2.5Mg Tablet|Prophylaxis of atherothrombotic events following an acute coronary syndrome with elevated cardiac biomarkers (in combination with aspirin alone or aspirin and clopidogrel)
15883776|NCT03775746|Drug|Ticagrelor 90Mg Tablet|Prevention of atherothrombotic events in patients with acute coronary syndrome [in combination with aspirin]
15883777|NCT03775733|Dietary Supplement|Hydrolysed Red Ginseng Extract|Hydrolysed Red Ginseng Extract 2.4g/day for 12 weeks.
15883778|NCT03775733|Dietary Supplement|Placebo|Placebo for 12 weeks.
15883779|NCT03775720|Behavioral|Dietary advice|Based on their genetic risk, participants are given advice to either adhere to general dietary guidelines related to salt intake or to reduce their salt intake to no more than 4 grams per day.
15883780|NCT03775707|Drug|Lenvatinib|12 mg (or 8 mg) once daily (QD) oral dosing.
15883781|NCT03775707|Drug|PD-1 antibody|3mg/kg intravenously every 2 weeks
15883782|NCT03775694|Device|dMRI Scan|Data will be collected from cases where dMRI scans were obtained as part of the subject's previous treatment.
15883783|NCT03775681|Procedure|Endoscopic Retrograde Cholangiopancreatography|Undergo standard of care ERCP
15883784|NCT03775681|Other|Interview|Ancillary studies
15883785|NCT03775681|Device|Laryngeal Mask Airway|Wear LMA
15883786|NCT03775668|Drug|1 µCi of 14C-AAI101 + 500 mg AAI101|Single dose open label
15883787|NCT03775655|Drug|Dexmedetomidine|10μg dexmedetomidine will be added to the injectate to be injected intrathecally
15883788|NCT03775642|Behavioral|Intervention video|The intervention video will employ the debiasing strategies. It will avoid directly articulating contraception-related myths, but instead will provide a limited number of alternative explanations related to IUD and implant safety.
15883789|NCT03775642|Behavioral|Control video|The video for the control arm will consist of an existing, public-use video on a non-contraception topic of similar duration
15883790|NCT03775629|Drug|Polmacoxib and Tramadol combination|Tramadol hydrochloride (HCl) 150mg, Polmacoxib 2mg
15883791|NCT03775629|Drug|Polmacoxib|Polmacoxib 2mg
15883792|NCT03775629|Drug|Tramadol hydrochloride|Tramadol hydrochloride (HCl) 150mg
15883793|NCT03775616|Other|Educational Intervention|Receive financial navigation program intervention
15883794|NCT03775616|Other|Questionnaire Administration|Ancillary studies
15883795|NCT03775616|Other|Quality-of-Life Assessment|Ancillary studies
15883796|NCT03775603|Device|TOFscan|comparison of TOFscan over TOF-Watch SX
15883797|NCT03775590|Procedure|Water|To evaluate using water in the treatment of atopic dermatitis
15883798|NCT03775590|Procedure|Bleach|To evaluate using water + dilute bleach in the treatment of atopic dermatitis
15894476|NCT03692949|Drug|LY3451838|One dose administered SC
15883800|NCT03775564|Other|REMEDRUGBY PROGRAM|"1st Session presentation of the programme, its objectives and a common reflection on the concepts of stigmatization/destigmatization.
~2nd to 4th session devoted to a group reflection on social conventions and their meaning followed by a practice by means of role-playing.
~5th to 7th session devoted to writing comments about tournaments on the blog by working on the intentions of others and the emotional impact of comments on their recipients.
~8th, 9th 11th sessions devoted to media relations with group reflection on the image of themselves and their pathology that participants wish to refer to the media, followed by a practice in role-playing games Interviewer-interviewed
~10th session devoted to planning and organizing the day of matches with writing a program of the day and spreading on the blog
~12th General Debriefing session Including : - 3 tournaments
~8 hours of Touch Rugby"
15883801|NCT03775564|Other|TOUCH RUGBY PROGRAM|Practical training Program at Touchrugby at the rate of 12 weekly sessions of 2 hours and 3 inter-institutional tournaments per day
15883802|NCT03775564|Other|TAU|Treatment as usual
15883803|NCT03775551|Behavioral|Improvement cycle|at least 6 workshops (sessions) will be held with the members of the care system, in order to identify opportunities for improvement oriented to the design and application of an innovative intervention based on best practices.
15883804|NCT03775538|Drug|Cerebral Dopamine Neurotrophic Factor|Repeated intracerebral infusions
15883805|NCT03775538|Device|Renishaw Drug Delivery System|Stereotactically implanted device
15883806|NCT03775525|Drug|GZ17-6.02|Super enhancer Inhibition
15883807|NCT03775512|Device|RF Ablation with QDOT Micro|Subjects will be ablated using QDOT Micro catheter
15883808|NCT03775499|Dietary Supplement|Intervention 1 : BL NCC 2705 + Maltodextrin|2 capsules of BL NCC 2705/day (1 in the morning and 1 in the evening) for 3 days + 1 capsule of BL NCC 2705 in the morning of the 4th day
15883809|NCT03775499|Other|Intervention 1 : Maltodextrin|2 capsules of Placebo/day (1 in the morning and 1 in the evening) for 3 days + 1 capsule of Placebo in the morning of the 4th day
15883810|NCT03775499|Dietary Supplement|Intervention 2 : BL NCC 2705 + Maltodextrin|2 capsules of BL NCC 2705/day (1 in the morning and 1 in the evening) for 3 days + 1 capsule of BL NCC 2705 in the morning of the 4th day
15883811|NCT03775499|Other|Intervention 2 : Maltodextrin|2 capsules of Placebo/day (1 in the morning and 1 in the evening) for 3 days + 1 capsule of Placebo in the morning of the 4th day
15883812|NCT03775486|Drug|Durvalumab|Initial therapy phase: IV infusion q3w for 4 cycles. Maintenance phase: IV infusion q4w.
15883813|NCT03775486|Drug|Placebo for Olaparib|Matching tablet
15883814|NCT03775486|Drug|Olaparib|150-mg tablets (2 × 150-mg tablets for 300-mg dose) 100-mg tablet available if dose reductions are required
15883815|NCT03775486|Drug|Nab-paclitaxel+carboplatin|Standard of Care chemotherapy (squamous and non-squamous patients)
15883816|NCT03775486|Drug|Gemcitabine+carboplatin|Standard of Care chemotherapy (squamous patients only)
15883817|NCT03775486|Drug|Pemetrexed+carboplatin|Standard of Care chemotherapy (non-squamous patients only)
15883818|NCT03775486|Drug|Gemcitabine+cisplatin|Standard of Care chemotherapy (squamous patients only)
15883819|NCT03775486|Drug|Pemetrexed+cisplatin|Standard of Care chemotherapy (non-squamous patients only)
15883820|NCT03775473|Diagnostic Test|progastrin|PROCODE is an interventional study of category 2 (non-medicinal product), with a minimal risks and restrictions, involving only one blood drawn at the screening of colon cancer.
15883821|NCT03775460|Drug|Methotrexate|Participants in the intervention group will receive methotrexate along side prednisolone
15883822|NCT03775460|Drug|Placebo|Participants in the control arm will receive placebo along side prednisolone
15883823|NCT03775460|Drug|Prednisolone|Participants in both arm will receive prednisolone, which will be the same dosage: 40 mg (initial dose) decreasing dosage for 20 weeks
15883824|NCT03775447|Procedure|Lumbar Puncture|Lumbar Puncture for collection of Cerebrospinal Fluids
15883825|NCT03775434|Drug|Experimental: B244|B244 suspension in 30ml/bottle
15883828|NCT03775395|Drug|Lenvatinib|12 mg (or 8 mg) once daily (QD) oral dosing.
15883829|NCT03775395|Drug|Sorafenib|400mg BID daily oral dosing
15883830|NCT03775395|Procedure|Hepatic arterial infusion chemotherapy|administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
15883831|NCT03775382|Other|Ascorbic Acid|"Ascorbic acid will be infused into an antecubital vein using a IV infusion pump beginning with a priming bolus of 0.06 g Ascorbic Acid per kg fat-free mass dissolved in 100 ml of saline followed by a drip-infusion of 0.02 g Ascorbic Acid per kg fat-free mass dissolved in 30 ml of saline."
15883832|NCT03775382|Other|Normal Saline|Normal saline will be infused by the research nurse into an antecubital vein using an IV infusion pump.
15883833|NCT03775369|Other|endurance training|physical activity and exercising (PAE)
15883834|NCT03775369|Other|social support and counseling|social support and counseling
15883835|NCT03775369|Other|resistance training|physical activity and exercising (PAE)
15883836|NCT03775356|Other|Treatment of hypotension and/or reduction of anesthetics|The treatment of hypotension can be done by the responsible anesthetist according to the clinical standard operations including any accepted drug typically used in this hospital. The reduction of anesthetics can be done either by reducing the volatile end tidal anesthetics concentration (ETAC) or the infusion rate of propofol.
15883837|NCT03775343|Diagnostic Test|Neurocognitive Test Battery|neurocognitive testing: preoperative(baseline), 6 and 24 hours postoperative.
15883838|NCT03775343|Diagnostic Test|Blood sampling|Blood sampling before surgery (baseline), immediately postoperative, 6 and 24 hours after surgery, investigating plasma levels of S 100-B, CRP, vitamines, homocysteine and folic acid
15883872|NCT03775057|Other|MyDoseCoach app|The intervention involves the use of the MyDose Coach application, which has been previously programmed with the following titration scheme according to fasting glucose.
15883873|NCT03775044|Device|Medherent Device|The Medherent Medication Management Device (MMD) is intended to enable patients to self-manage their medication at home when it may otherwise require assistance.
15884524|NCT03769922|Procedure|Limited mesenteric excision|The mesentery is retained.
15883839|NCT03775330|Radiation|Stereotactic Radiosurgery (SRS)|"SRS or hypofractionated stereotactic radiation delivered via the Leksell Gammknife Perfexion/Icon radiosurgery system. Hypofractionated stereotactic radiotherapy 25-32.5 Gy in 5 fractions or 24-27 Gy in 3 fractions at the discretion of the radiation oncologist
~Maximum diameter of metastasis (doses in single fraction):
~≤ 2 cm: 15-20 Gy > 2 cm and ≤ 3 cm: 15-18 Gy > 3 cm and ≤ 4 cm: 15 Gy
~Tumour location (doses in single fraction):
~Brainstem: 15 Gy
~Hypofractionated stereotactic radiotherapy 25-32.5 Gy in 5 fractions may be used for lesions > 2 cm at the discretion of the radiation oncologist
~Note: SRS dosing reduced by 20% (for all prescriptions > 15 Gy) when patient is randomized to SRS + WBRT arm"
15883840|NCT03775330|Radiation|Whole brain radiation (WBRT)|WBRT 20 Gy in 5 fractions or 30 Gy in 10 fractions at the discretion of the radiation oncologist
15883841|NCT03775317|Procedure|Video Laryngoscopy|The direct, or conventional, laryngoscopy group will undergo the planned nasotracheal intubation utilizing a Macintosh or Miller laryngoscope for direct visualization of the larynx.
15883842|NCT03775317|Procedure|Direct Laryngoscopy|The video-assisted laryngoscopy group will undergo the planned nasotracheal intubation utilizing a Storz C-MAC S Video Laryngoscope to allow for indirect visualization of the larynx.
15883843|NCT03775291|Diagnostic Test|Simultaneous assessment of sleep apnea by polysomnogram and wearable device|Characterization of sleep apnea by lab-based polysomnogram
15883844|NCT03775278|Drug|PHP-303|Investigational drug
15883845|NCT03775278|Other|Placebo|Matching placebo
15883854|NCT03775252|Dietary Supplement|Ketogenic diet|Diet rich in fats and poor in carbohydrate, to induce metabolic ketosis
15883855|NCT03775239|Behavioral|Mindfulness in Sex Therapy and Intimate Relationships (MSIR)|"Mindfulness is a mental discipline inviting intentional, non-judgmental attending of the stream of experience. Mindfulness can be seen as an adjunct to sexual therapy. Firstly, it is a way of teaching the patients and the couples to carry out sensate focus so that it can achieve its goals. Beyond this, Mindfulness may invite a stance to one's own and a partner's physical and emotional experience that is more widely beneficial. The MSIR intervention was originally developed from the Mindfulness Based Cognitive Therapy (MBCT) protocol and consists of:
~Week 1: Moving into the Body Week 2: Sensing & Exploring Week 3: Avoidance & Intimacy- Midway individual session. Week 4: Recognising our automatic mind Week 5: Spacious Awareness Week 6: Expanding new learning"
15883856|NCT03775239|Behavioral|Treatment-as-usual|"The current treatment in Sexological Clinic is an eclectic, synthetic therapy form conducted by psychiatrists, other medical doctors, psychologists and bodytherapists.
~In order to implement the bio-psycho-social character of sexual dysfunctions, the current treatment takes advantage of different elements from different therapy forms combined with pharmacological treatment if necessary.
~The integrated treatment combines elements from therapy's such as cognitive behavioural therapy (CBT), psychodynamic therapy and systemic therapy together with Master and Johnson's sensate focus training, body exercises training as pelvis floor exercises, introduction of sexual aids and if necessary pharmacological treatment. The therapy can be individual treatment, couple therapy (marital therapy) or group therapy."
15883857|NCT03775226|Device|ChampioNIR® SFA Stent|The ChampioNIR® SFA Stent is composed of a Nitinol alloy structure with an elastomeric micro-fiber mesh and is designed specifically to be used in the peripheral vasculature. The stent is characterized by high flexibility, strong radial support and high resistance to fractures, as well as high deliverability and precise positioning.
15883860|NCT03775200|Drug|Psilocybin|Dose-ranging
15883862|NCT03775174|Drug|Mepsevii|
15883863|NCT03775161|Device|V-LAP™ System|Delivery of the V-LAP™ implant via a catheter-based approach in a trans-septal puncture procedure, deploying it in the inter-atrial septum.
15883864|NCT03775148|Behavioral|Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C)|TranS-C integrates elements of evidence-based interventions, namely cognitive-behavioural therapy for insomnia, delayed sleep phase type, and interpersonal and social rhythm therapy.
15883865|NCT03775135|Other|Questionnaires|Different questionnaires about identity development and psychosocial functioning will be administered
15883866|NCT03775122|Device|TAES|TAES over acupuncture point neiguan (pericardium 6) for 20min, placebo group only stick the stimulate electrode but no frequency and intensity
15883867|NCT03775109|Drug|Canakinumab 150mg/ml solution for injection|Canakinumab 150mg/ml solution for injection
15883868|NCT03775109|Drug|Placebo|100ml 5% Dextrose
15883869|NCT03775096|Drug|Carvedilol|At the end of Baseline visit, carvedilol 3.125 twice daily will be initiated and maintained for 1 week, increased to 6.25twice daily (dispensed at week 1visit), to 12.5mg twice daily (dispensed at week 2) and a max dose of 25mg twice daily (dispensed at week 4 visit), as tolerated. A subject that cannot tolerate at least a 25 mg daily dose will be excluded from the study. Subjects that cannot tolerate the 50 mg daily dose, will be offered to continue at the 25 mg daily dose. The project will include a washout period at study end.
15883870|NCT03775083|Drug|Currently approved medications|subjects will be treated according to current Department of Health and Human Services (DHHS) Center for Disease control and prevention (CDC), Society for Healthcare Epidemiology of American (SHEA guidelines for nPEP
15883871|NCT03775070|Drug|Simvastatin|"Starting dosage: in adult, the dose of simvastatin is 10 mg once daily. In children, the dose is 0.25mg/Kg/day (maximum dose: 10 mg/d).
~Target dosage: in adult, the dose of simvastatin is 20 mg once daily. In children, the dose is 0.5mg/Kg/day (maximum dose: 20 mg/d).
~The basic anti-congestive medication will be kept as the same.
~The dosage may be titrated to a lesser dose by investigators according to the patient's condition."
15883875|NCT03775018|Procedure|Transversus abdominis plane blockade|Patients will undergo Transversus abdominis plane blockade with Bupivacaine 0.25% 30ml, applied in the plane between the internal oblique muscle and the trasnversus abdominis. The injection will be performed laterally to the port-sites, bilaterally at the same levels.
15883876|NCT03775018|Drug|Intravenous analgesia|Acetaminophen 1g/6h iv will be administered
15883877|NCT03775005|Radiation|standard treatment|3000 cGy in 10 daily fractions
15883878|NCT03775005|Radiation|short course treatment|1800 cGy in 4 fractions administered twice a day
15883879|NCT03774992|Device|Orthokeratology lenses|Custom fit, form stable contact lenses
15883880|NCT03774979|Drug|SHR-1701|Subjects will receive an intravenous infusion of SHR-1701 in a pre-set dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the trial.
15883881|NCT03774966|Procedure|Adductor Canal Block + Catheter & IPACK block|Adductor Canal Block + Catheter & IPACK block
15883882|NCT03774966|Procedure|Adductor canal block + catheter|Adductor canal block + catheter
15883883|NCT03774953|Dietary Supplement|Protein and vitamin supplementation|The intervention group will receive 1.5 g protein/kilo/day during hospitalization and a standard dose of 27 g protein/day in 60 days after discharged together with a daily dose of vitamin/mineral supplement
15883884|NCT03774940|Diagnostic Test|peripheric blood count|preoperative peripheric blood count
15883885|NCT03774927|Device|10 Hz treatment group|10 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 27-s intervals with 20s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 8 consecutive weeks.
15883886|NCT03774927|Device|20 Hz treatment group|20 Hz stimulations over left DLPFC occurred at a power of 110% of MT for 20 intervals with 28s inter-train interval. 20 minutes were administered each day (Monday-Friday) for 8 consecutive weeks.
15883887|NCT03774927|Device|Control Group|all procedures were identical to 10Hz group except they were the non-magnetized steel cylinders, instead of cylindrical magnets, that were rotated.
15883888|NCT03774914|Drug|Alemtuzumab (GZ402673)|Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous infusion
15883889|NCT03774901|Drug|Avelumab|intravenous 10 mg/kg every 2 weeks
15883890|NCT03774888|Procedure|Connective tissue graft at time of bone graft|following the placement of the bone graft and the membrane, a CTG will be harvested and sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft
15883891|NCT03774888|Procedure|Acellular Demal Matrix at time of bone graft|following the placement of the bone graft and the membrane, an ADM will be sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft
15883892|NCT03774888|Procedure|No soft tissue grafting at time of bone graft|Following the placement of the bone graft and the membrane, the flaps passively sutured on top on the bone. No soft tissue graft will be added.
15883893|NCT03774875|Drug|Apremilast (CC-10004)|"This study will randomize subjects to either apremilast 30 mg BID or placebo comparator in a 2:1 ratio, respectively. Subjects randomized to apremilast will receive dose-titration for the initial 5 days. Apremilast subjects will receive dummy titration at wk 16 to maintain the blinding of the original treatment assignments. Investigational product (IP) will be dispensed in blinded dose cards until Week 20. Thereafter, IP will be dispensed in open-label bottles."
15883894|NCT03774875|Other|Placebo|Subjects randomized to the placebo treatment group will receive placebo tablets (identical in appearance to the apremilast 30 mg tablets) orally twice daily for 16 weeks.
15883895|NCT03774875|Drug|Apremilast (CC-10004)|Beginning at Week 16 and after a 5-day titration with apremilast, subjects initially randomized to placebo will be switched to receive apremilast 30 mg BID for 36 weeks (52 weeks total). Investigational product (IP) will be dispensed in blinded dose cards until Week 20. Thereafter, IP will be dispensed in open-label bottles
15883896|NCT03774849|Device|PicoWay™ 532nm fractional handpiece|PicoWay™ Laser System is picosecond 532/1064/785 laser
15883897|NCT03774849|Device|PicoWay™ 730nm wavelength|PicoWay™ Laser System is picosecond 532/1064/785 laser
15883898|NCT03774849|Device|PicoWay™ 1064nm fractional handpiece|PicoWay™ Laser System is picosecond 532/1064/785 laser
15883899|NCT03774836|Drug|Tramadol|IV Tramadol 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
15883900|NCT03774836|Drug|Morphine|Morphine 4 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
15883901|NCT03774836|Other|Placebo|Placebo, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
15883902|NCT03774823|Device|RF and PEMF|RF and PEMF treatment is deployed using either a small or large handpick applied to the skin and moved slow random patterns homogeneously over the area of treatment
15883903|NCT03774823|Device|Ultrasound|Ultrasound is applied to the subject by placing a probe on the treatment area and moving it rapidly and homogeneously over the treatment area
15883904|NCT03774810|Drug|Zolpidem tartrate|Zolpidem Tartrate, 5mg for men older than 60 and women of all ages. 10 mg for men younger than 60.
15883905|NCT03774797|Other|Implementation Toolkit|Post-implementation patients and providers will be assessed after the implementation toolkit has been used to improve service delivery at the study site.
15883906|NCT03774771|Drug|Cinacalcet|Capsule for oral administration
15883907|NCT03774771|Drug|Placebo|Capsules for oral administration
15883908|NCT03774758|Diagnostic Test|Guardant Health ct-DNA LUNAR assay|Guardant Health is focused on conquering cancer by using its breakthrough blood-based assays, vast data sets, and advanced analytics. In 2016, it announced Project LUNAR, an effort to apply Guardant Health's technology platform to early detection, recurrence monitoring, and assessing minimal residual disease.
15883909|NCT03774745|Drug|Mifepristone 200 MG|All subjects receive mifepristone tablet on treatment day 1.
15883910|NCT03774745|Drug|micronized Progesterone|Subjects randomized to progesterone receive treatment starting day 2.
15883911|NCT03774745|Drug|Placebo oral capsule|Subjects randomized to placebo receive treatment starting day 2.
15883912|NCT03774732|Radiation|Radiotherapy|Irradiation technique (3D-CRT or SABR) will be at physician discretion.
15883913|NCT03774732|Drug|Pembrolizumab|pembrolizumab will be administered as per standard of care every 3 weeks until progression or toxicity
15883955|NCT03774381|Dietary Supplement|Bifidobacterium breve B-3|160 mg of Bifidobacterium breve B-3 is orally administered per day for 12 weeks.
15883914|NCT03774732|Drug|Chemotherapy|for squamous NSCLC carboplatin AUC6, paclitaxel 200 mg/m² every 3 weeks for 4 cycles; for non-squamous NSCLC carboplatin AUC5 or cisplatin 75 mg/m² every 3 weeks for 4 cycles, and pemetrexed 500 mg/m² every 3 weeks until progression or toxicity
15883915|NCT03774719|Device|Hand-carried ultrasound|Hand-carried ultrasound of both kidneys to detect the presence or absence of hydronephrosis. Device used will be the lumify portable ultrasound equipped with the C5-2 curved array transducer (Philips, USA).
15883916|NCT03774706|Drug|Misoprostol|two tablets misoprostol 400 μg sublingual
15883917|NCT03774706|Drug|Tranexamic Acid|two ampoules of tranexamic acid (1gm in 10 ml) in 100ml saline
15883918|NCT03774706|Drug|placebo to tranexamic acid|placebo to tranexamic acid (110 ml saline)
15883919|NCT03774693|Other|General anesthesia with fentanyl boluses|Patients will receive general anesthesia with Fentanyl boluses of 0.5 mcg.Kg-1 given to maintain MAP between 55-65 mmHg with a maximum dose of 3 mcg.Kg-1
15883920|NCT03774693|Procedure|Regional block|Patients will receive trans-oral bilateral sphenopalatine ganglion block and trans-oral bilateral infraorbital nerve block.
15883921|NCT03774680|Drug|Cetuximab nanoparticles|The active group will receive cetuximab in nanoparticles as an anti-microbial drug.
15883922|NCT03774680|Drug|Oral approved anticancer drug|The placebo group will receive topical FDA approved anti-microbial jel in different dosage forms as control drug.
15883923|NCT03774654|Genetic|CD19.CAR-aNKT cells|"Patients will be given the T-cell product by intravenous injection (into the vein through an IV line) at the assigned dose.
~Dose Level 1: 1 x 10^7/m2. Dose Level 2: 3 x 10^7/m2. Dose Level 3: 1 x 10^8/m2."
15883924|NCT03774654|Drug|Cyclophosphamide|Lymphodepletion chemotherapy. Patients will receive 3 daily doses of cyclophosphamide (500mg/m^2/day) finishing at least 24 hours before T-cell infusion. The drug will be given intravenously (through an IV needle).
15883925|NCT03774654|Drug|Fludarabine|Lymphodepletion chemotherapy. Patients will receive 3 daily doses of fludarabine (30mg/m^2/day) finishing at least 24 hours before T-cell infusion. The drug will be given intravenously (through an IV needle).
15883926|NCT03774641|Drug|Lamictal|Blood-serum levels will be checked monthly during pregnancy and reference concentration will be maintained
15883927|NCT03774628|Biological|Chengdu Kanghua (one booster shot)|A rabies vaccine (human diploid cell) for human use, Freeze-dried produced by Chengdu Kanghua Biological Products Co.,Ltd. 1.0 ml experimental vaccine on day 0
15883928|NCT03774628|Biological|Chengdu Kanghua (two booster shots)|A rabies vaccine (human diploid cell) for human use, Freeze-dried produced by Chengdu Kanghua Biological Products Co.,Ltd. 1.0 ml experimental vaccine on day 0 and 3
15883929|NCT03774615|Drug|Ferric maltol 30 mg (Feraccru®)|Feraccru® 30 mg hard capsules will be used. Each capsule contains 30 mg iron (as ferric maltol), 91.5 mg of lactose, 0.5 mg of Allura Red AC (E129) and 0.3 mg Sunset Yellow FCF (E110) as excipients with known effects
15883930|NCT03774602|Behavioral|Health promotion and provision of RMNCH services|Implementation of quality, high-impact interventions at institutional and community levels to increase access to and utilization of RMNCH services
15883931|NCT03774589|Procedure|Magnetic Compressive Anastomosis|The magnetic compressive anastomosis will be used to complete the anastomosis during bilioenteric anastomosis.
15883932|NCT03774589|Procedure|Manual Anastomosis|A handsewn technique will be used to complete the anastomosis during bilioenteric anastomosis.
15883933|NCT03774576|Drug|RO7017773|Single doses of RO7017773
15883934|NCT03774576|Drug|Itraconazole|Multiple doses of Itraconazole
15883935|NCT03774537|Drug|Transplantation of hUC-MSCs|Preterm infants at high risk for BPD will receive transplantation of hUC-MSCs through intravenous infusion. Dose A - 1 million cells per kg; Dose B - 5 million cells per kg
15883936|NCT03774537|Drug|No transplantation of hUC-MSCs|Preterm infants at high risk for BPD will not receive transplantation of hUC-MSCs
15883937|NCT03774524|Drug|Misoprostol|400 μg of sublingual misoprostol
15883938|NCT03774524|Drug|TA|1 gm of tranexamic acid in 100 ml saline iv
15883939|NCT03774524|Drug|placebo to misoprostol|placebo tablets to misoprostol subligual
15883940|NCT03774524|Drug|placebo to TA|110 ml saline iv
15883941|NCT03774511|Other|High-Intensity Interval Exercise & Moderate Intensity Interval Exercise|Different Interval intensities Exercise
15883942|NCT03774498|Drug|Sensodyne repair and protect|NovaMin & fluoride toothpaste
15883943|NCT03774485|Device|G-Tech Gutcheck Myoelectric recording device|Three G-Tech patches are placed on the abdomen of the patient to record myoelectric activity.
15883944|NCT03774472|Drug|Hydroxychloroquine|Given PO
15883945|NCT03774472|Drug|Letrozole|Given PO
15883946|NCT03774472|Drug|Palbociclib|Given PO
15883947|NCT03774459|Drug|High dose ANAVEX2-73|Active oral capsule
15883948|NCT03774459|Drug|Mid dose ANAVEX2-73|Active oral capsule
15883949|NCT03774459|Drug|Placebo oral capsule|Placebo oral capsule
15883950|NCT03774446|Drug|Seliciclib|Drug: Seliciclib
15883951|NCT03774433|Behavioral|Laddr|"Laddr is an integrated, personalized, web-based self-regulation assessment and behavior change system. It integrates tools that have been shown to be effective for a wide array of behavioral phenomena ranging from substance use and abuse, mental health, risk-taking, chronic pain management, medication adherence, diet, exercise, diabetes and other chronic disease management, and smoking. The organizational structure, functionality and content within Laddr's system centrally embrace these fundamental aspects of behavior change; thus, the Laddr platform is not diagnosis-specific but rather enables integrated care for any combination of individuals' goals, needs, and preferences."
15883952|NCT03774407|Drug|vaginal estriol|Estriol vaginal cream will be formulated by Twin Oaks specialty pharmacy-by the same compound specialist. 30 mg estriol powder will be mixed with 5 mL of propylene glycol and 22 g of vaginal base cream. The product can be stored at room temperature and has a shelf life of up to 4 months. It comes with an applicator.
15883953|NCT03774394|Drug|Clopidogrel|Both CKD and Non-CKD patients will be administered a 600-mg LD of clopidogrel followed by a single 75-mg MD administered after 24 hours.
15883954|NCT03774394|Drug|Clopidogrel active metabolite|In both CKD and Non-CKD patients, blood samples collected at baseline only (before clopidogrel LD administration) will be incubated with escalating concentrations of clopidogrel active metabolite (1, 3 and 10 μM)
15883956|NCT03774381|Dietary Supplement|Control group|160 mg of placebo is orally administered per day for 12 weeks.
15883957|NCT03774368|Other|Emergency contraception website|Existing website with factual information about emergency contraception
15883958|NCT03774368|Other|Emergency contraception video|Existing video with factual information about emergency contraception
15883959|NCT03774355|Drug|CG1801|Administration CG1801 2mg single dose in phase 1 and Administration CGL1802 2mg single dose phase 2.
15883960|NCT03774355|Drug|CGL1802|Administration CGL1802 2mg single dose in phase 1 and Administration CG1801 2mg single dose phase 2
15883961|NCT03774342|Procedure|Coronary Artery Bypass Grafting|Patients undergoing coronary artery bypass grafting
15883962|NCT03774329|Other|Usual care|Patients included in the control group will not benefit from the intervention in adapted physical activity. However, this will not affect their support. Patients will be seen by their specialist doctor as part of the usual management of their IBD.
15883963|NCT03774329|Other|adapted physical activity|Patients in the experimental group will have, in addition to their usual follow-up with their specialist doctor, an intervention in adapted physical activity at home, at the rate of 3 sessions (of a duration of 10 to 20 minutes) per week during 9 consecutive months.
15883964|NCT03774303|Other|Mobile application|A mobile application that will be used to prepare families for day surgery
15883965|NCT03774303|Other|current practice|the current practice used to prepare families for day surgery
15883966|NCT03774290|Drug|PBF-680|PBF-680 is an adenosine A1 receptor antagonist
15883967|NCT03774290|Drug|Placebo oral capsule|Oral gelatine capsule
15883968|NCT03774277|Behavioral|Packed Promise for a Healthy Heart|"Voucher for fresh vegetables and fruits (referred to as a fresh check); Home delivered food boxes that contain Dietary Approaches to Stop Hypertension (DASH)-approved ingredients for preparing low-salt, and traditional healthy Chickasaw meals; Heart-healthy recipes (available at getfreshcooking.com) that are tailored to traditional Chickasaw diet and culture; Educational materials; Personalized invitation to attend local cooking demonstrations; Assistance to link the Fitbit and AYA app"
15883969|NCT03774251|Biological|Platelet-Rich Plasma Injection|The patient will undergo a single platelet-rich plasma peritendinous injection
15883970|NCT03774251|Device|Extracorporeal Shock Wave Therapy|The patient will undergo a series of three extracorporeal shock wave therapy treatments to the lateral hip
15883971|NCT03774238|Other|FMD analysis|Blood sample and vascular exploration.
15883972|NCT03774225|Other|Virtual Reality with Manual and Verbal Guidance|Participants will perform 4 balance games during 8 sessions with a manually and verbally assisted by a experient physiotherapist.
15883973|NCT03774225|Other|Virtual Reality with No Manual and Verbal Guidance|Participants will perform 4 balance games during 8 sessions in the presence of a experient physiotherapist that will ensure patient safety, providing motivational verbal stimuli, and replicating the feedback provided by the game.
15883974|NCT03774225|Other|Physical Therapy|Patients of the control group will be trained with balance exercises by a experient physiotherapist.
15883975|NCT03774212|Device|Active noise cancelling headphones|The white noise will play from an 'iPod touch' (Apple), through the active noise cancelling headphones.
15883976|NCT03774199|Device|NightOwl|The NightOwl is a finger and/or forehead mounted device with, among other functions, the capability to acquire double-wavelength PPG, from which SpO2 can be derived
15883977|NCT03774186|Device|Hybrid closed-loop therapy|Hybrid closed-loop therapy with a proportional integral derivative (PID) algorithm
15883978|NCT03774186|Device|Sensor-augmented pump therapy|Insulin pump + non-communicating CGM
15883979|NCT03774173|Drug|Aramchol|One Aramchol tablet (300 mg) twice daily and 2 Aramchol tablets (300 mg each) once daily
15883980|NCT03774160|Behavioral|Generacion Actual|See description in arm description.
15883981|NCT03774147|Device|24-hour Ambulatory Blood Pressure Monitoring (ABPM)|
15883982|NCT03774134|Procedure|Complete mesocolic excision|Based on the principles of CME. The inferior mesenteric artery (IMA) was divided at its origin from the aorta to perform central lymph nodes dissection along the IMA between the aorta and the branching of the left colic artery. Sigmoid resection included the complete sigmoid colon and resection of the upper part of the rectum to ensure sufficient perfusion of the colo-rectal anastomosis. To achieve sufficient distance at the proximal bowel resection margin, parts of the descending colon or even left hemicolectomy were performed at the surgeon's discretion.
15883983|NCT03774134|Procedure|Conventional colon resection|The patients underwent what was considered standard colon cancer resections in Denmark during the study period.
15883984|NCT03774121|Device|Cryoneurolysis|A cryoprobe will be inserted percutaneously and freeze the target nerves (infrapatellar branch of the saphenous nerve & anterior femoral cutaneous nerve) guided by ultrasound visualization.
15883985|NCT03774121|Other|Neuromuscular exercise (GLA:D)|The GLA:D program, is a standard education and exercise program for patients with osteoarthritis in Denmark. The program is performed in groups and with the supervision of an experienced physiotherapist specialized in training of musculoskeletal disorders.
15883986|NCT03774121|Device|Sham|The sham intervention includes a similar procedure but without freezing temperatures.
15883987|NCT03774108|Drug|Metformin Hydrochloride 850 MG|8 weeks tratment with oral metformin
15883988|NCT03774108|Other|Placebo|8 weeks tratment with oral placebo
15883989|NCT03774095|Dietary Supplement|Hydrolyzed pine nut oil|Given 30 min prior to oral glucose tolerance test
15883990|NCT03774095|Dietary Supplement|Hydrolyzed pine nut oil and olive oil|Given 30 min prior to oral glucose tolerance test
15883992|NCT03774069|Device|DreaMed Advisor Pro|Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted using the DreaMed Advisor Pro and sent directly to the patient
15883993|NCT03774069|Other|Medical guided recommendation|Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted by the medical team according to standard of care
15883994|NCT03774056|Drug|HC-1119|oral
15883995|NCT03774043|Other|Acute Intermittent Hypoxia|Patients will breath 9%-11% oxigen for 1.5 minutes interspersed with 1.5 minutes of 21% oxigen (normoxia), 15 times for a total of 45 minutes.
15883996|NCT03774043|Other|Sham Acute Intermittent Hypoxia|Patients will breath 21% oxigen for 1.5 minutes interspersed with 1.5 minutes of room air, 15 times for a total of 45 minutes.
15883997|NCT03774030|Procedure|several virtual 3-D complex audio environments|The focus is a comparison of 3 hearing aid algorithms in a virtual 3-D complex audio Environment.
15883998|NCT03774017|Procedure|one-staged hybrid operation|An integrated procedure that consists of microsurgery, intraoperative DSA, endovascular intervention techniques and other assistance tools. All the procedures are performed in a one-staged operation without any intermission or any transfer of patients.
15883999|NCT03774017|Procedure|Traditional microsurgical operation|The classical mode of operations in neurosurgery. The operation is performed with neurosurgical instruments and microscope. Some of assisting tools can be used in the operation, such as neuro-navigation, Doppler probe, neural electrophysiological monitoring and so on. But neither the intraoperative DSA nor endovascular intervention techniques is used in the operation
15884000|NCT03773991|Diagnostic Test|Lung MRI|Proton Lung Magnetic Resonance Imaging
15884001|NCT03773991|Diagnostic Test|Sodium MRI|Sodium Soft Tissue Magnetic Resonance Imaging
15884002|NCT03773991|Diagnostic Test|Chest CT|High-resolution Quantitative Chest CT
15884003|NCT03773991|Diagnostic Test|Echocardiography|Transthoracic 2D Speckle-Tracking Echocardiography
15884004|NCT03773991|Diagnostic Test|Fractional Exhaled Nitric Oxide|Fractional Exhaled Nitric Oxide testing
15884005|NCT03773991|Diagnostic Test|Pulmonary Function Tests|Spirometry and Plethysmography
15884006|NCT03773991|Diagnostic Test|Blood Sampling|Blood testing for: standard-of-care, inflammatory biomarkers, uremic toxins
15884007|NCT03773991|Diagnostic Test|Six-Minute Walk Test|Six-Minute Walk Test
15884008|NCT03773991|Diagnostic Test|Dyspnea Questionnaires|Modified Medical Research Council; University of California, San Diego Shortness of Breath Questionnaire; Borg Scale
15884009|NCT03773978|Drug|Baricitinib|Administered orally.
15884010|NCT03773978|Drug|Placebo|Administered orally.
15884012|NCT03773952|Drug|PBF-677|oral small molecule, antagonist of Adenosine A3 receptor (AA3R)
15884013|NCT03773952|Drug|Placebo oral capsule|Oral capsules
15884014|NCT03773926|Device|Neuro-feedback therapy|The therapy consists of 10 Neuro-feedback training sessions, 2 times per week over 5 weeks.
15884015|NCT03773913|Other|ICBHSS model|"Bundle of evidence-based interventions that include the following 5 components:
~Community engagement meetings and feedback;
~Elimination of public sector facility user fees for children under five and pregnant women;
~Pro-active community based IMCI using trained, equipped, supervised, and salaried Community Health Workers (CHWs) with additional services including linkage to family planning and counseling, HIV testing & referrals;
~Clinical mentoring and enhanced supervision by a trained peer coach at public sector facilities;
~Basic infrastructure improvements and supply chain management training of pharmacy managers"
15884016|NCT03773900|Dietary Supplement|Kiotransine (chitin-glucan from aspergillus niger)|The volunteers will take three times a day one bag of powder containing 1.5g of chitin-glucan fiber during three weeks. The powder will be diluted in water.
15884017|NCT03773900|Dietary Supplement|Placebo|The volunteers will take three times a day one bag of powder containing placebo during three weeks. The powder will be diluted in water.
15884018|NCT03773887|Other|collection of liver biopsies collection of blood samples|blood and ascites samples; extraction of explants, hepatic resection parts; hepatic parenchyma on liver biopsies
15884019|NCT03773874|Other|Assessment|Evaluation
15884020|NCT03773861|Other|errors made in one BLS session|BLS instructors have to oversee a standardized BLS training session, where standardized errors are made by trained volunteers.
15884021|NCT03773848|Procedure|Open Reduction Internal Fixation (ORIF)|Open Reduction Internal Fixation (ORIF) of fracture lateral third clavicle by hook plate & tightrope
15884022|NCT03773835|Drug|HSK3486|Mmanual IV bolus injection completed in 1 minute.
15884023|NCT03773822|Combination Product|Hydrocortisone + Flucortac|Low dose steroids
15884024|NCT03773822|Other|Placebo|Placebo
15884025|NCT03773809|Other|Vitamin D capsule|The intervention was given by oral administration of vitamin D3 capsule each of which contains 40000 IU of vitamin D3. The capsule was manufactured and supplied by Beximco Pharmaceutical Limited, Bangladesh. The placebo was also be manufactured and supplied by the same pharmaceutical company and was similar in size shape & appearance to vitamin D3 capsule but contained all the ingredients of vitamin D capsule other than the vitamin D3
15884026|NCT03773809|Other|placebo|oral administration of placebo
15884027|NCT03773796|Drug|Nabilone 0.25 mg|capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis
15884028|NCT03773783|Device|Button and Bead appliance|Button and Bead appliance
15884029|NCT03773783|Device|Twin Block appliance|Twin Block appliance
15884031|NCT03773757|Behavioral|IN-PEACE Dementia Care Coordination|Patient/Caregivers assigned to the intervention arm will have monthly phone calls with a Nurse or Social Worker, in the capacity of a Dementia care coordinator (DCC) to identify symptoms and behavior problems the person with memory problems is having, including: pain, sadness, or other symptoms. The Dementia Care Coordinator will consult with the project clinical team to develop a plan of care utilizing standardized protocols to reduce the burdens of disease associated symptoms and behaviors. In addition, education and support materials will be provided to the caregiver in the role caring and management of a patient with dementia.
15884032|NCT03773744|Drug|Ad-MAGEA3|Adenovirus vaccine expressing Melanoma-associated antigen 3 (MAGEA3), a tumor antigen
15884033|NCT03773744|Drug|MG1-MAGEA3|MG1 Maraba oncolytic virus expressing Melanoma-associated antigen 3 (MAGEA3), a tumor antigen
15884034|NCT03773744|Drug|Pembrolizumab|monoclonal antibody; checkpoint inhibitor of PD1
15884035|NCT03773744|Drug|Cyclophosphamide|low-dose chemotherapy
15884036|NCT03773731|Behavioral|High intensity interval training (HIIT)|Exercise training on bicycle ergometer with high intensity bouts of 1 min interspersed by low intensity recovery intervals
15884037|NCT03773731|Behavioral|Moderate intensity continuous training (MICT)|Exercise training on bicycle ergometer with moderate intensity (60 - 65 % of individual maximal power output)
15884038|NCT03773705|Procedure|Electrocautery versus scalpel|Electrocautery versus scalpel in the elevation of nasoseptal flaps following endoscopic transsphenoidal pituitary surgery
15884134|NCT03772977|Behavioral|Brain Health Champion|A health coach embedded within an existing clinical care team
15884039|NCT03773692|Behavioral|Passive feedback and JITAI|"Second Phase - PA Level Feedback
~A PA recommendation handout based on PA guidelines for individuals with SCI will be provided. Participants continue to use the same sensing equipment as in phase one (baseline). The equipment consists of a smartwatch, a smartphone, and a wheel rotation monitor. Participants can view their feedback whenever they want, but will not be prompted with the information.
~Third Phase - PA Level Feedback and Just-in-time Adaptive Intervention (JITAI)
~The third phase of the study will be similar to the second phase of the study, but with an additional JITAI component. The JITAI component of the study will include providing proactively-prompted, real-time feedback through the smartphone and smartwatch when the participant performs a bout of moderate PA."
15884040|NCT03773679|Procedure|Daily Exercise|Daily Exercise Programme
15884041|NCT03773666|Drug|Durvalumab|Durvalumab is a monoclonal antibody (an antibody is a protein produced by the body's immune system) that works by blocking the Programmed Cell Death Ligand 1 (PD-L1), a protein on cancer cells that stops the body's immune system from killing cancer cells.
15884042|NCT03773666|Drug|Oleclumab|Oleclumab is a monoclonal antibody that works by reducing the amount of adenosine, a small molecule called a metabolite that binds to adenosine receptors on immune cells to regulate the immune system and suppress the immune response. Reducing the amount of immunosuppressive adenosine can increase the body's immune response to kill cancer cells.
15884043|NCT03773653|Behavioral|BMT to be combined with BAT|Specifically, the participants will first receive 40 to 45 minutes of bilateral robotic priming using the BMT. After the robotic priming, participants will receive another 40 to 45 minutes training in tasks focusing on bilateral symmetric movements of both ULs.
15884044|NCT03773653|Behavioral|BMT to be combined with MT|Similar to the RT+BAT group, the participants will first receive 40 to 45 minutes of bilateral robotic priming delivered by the BMT with the same priming protocol. After bilateral robotic priming, participants will receive 40 to 45 minutes of mirror therapy.
15884045|NCT03773653|Behavioral|BMT to be combined with IOT|Similar to the RT+BAT group, the participants will first receive 40 to 45 minutes of bilateral robotic priming delivered by the BMT with the same priming protocol. After bilateral robotic priming, participants will receive 40 to 45 minutes of impairment-oriented training.
15884046|NCT03773640|Device|Radio frequency currents|Study group (I) consist of patients who were treated with the occlusal splints and radio frequency currents. In the case of application of radiation to the muscle area, the energy was 20 J and 15 J to the area of the masticatory muscles, the frequency was 3 MHz, bipolar technique, the duration of the procedure was 10 minutes, the coupling substance was a gel for ultrasound examinations.
15884047|NCT03773640|Drug|Sonophoresis|The control group ( II) consisted of 20 patients treated with occlusion splints and sonophoresis procedures. For the area of mastication muscles 0.9 W/cm² treatments were applied, the duty factor was 80%, the treatment time was 10 minutes, and the medical substance was 25%Voltaren gel.
15884048|NCT03773601|Other|Sleep Profiler|A 4-days sleep monitoring with the use of the Sleep Profiler. Data on objective sleep behavior will be collected.
15884049|NCT03773601|Other|PSQI|Fill the Pittsburgh Sleep Quality Index (PSQI) for the subjective evaluation of sleep.
15884050|NCT03773601|Other|TQR|Fill the Total Quality of Recovery Scale (TQR), every morning for 4 consecutive days, to collect data on subjective perception of recovery,
15884051|NCT03773588|Device|Closed-Loop propofol Target controlled infusion by Entropy and SPI|Closed loop target infusion of propofol using BD TCI pumps guided by entropy and Surgical pleth index
15884052|NCT03773588|Device|Open-loop propofol target controlled infusion|Propofol target controlled infusion using Schnider algorithm to determine effect site concentration
15884053|NCT03773575|Device|PREVENA™ PEEL & PLACE™ Dressing Kit|In combination with a negative pressure pump (V.A.C. ® Therapy Unit, KCI USA, Inc.), the Prevena dressing is designed to provide negative pressure wound therapy (NPWT) over surgical incisions (incisional NPWT).
15884054|NCT03773562|Drug|Erenumab|Erenumab will be used per label instructions.
15884055|NCT03773549|Other|Virtual reality experience|Expose all participants (healthy and control) to virtual reality videos while collecting reactivity and self-report outcome measures.
15884056|NCT03773536|Drug|Artesunate-amodiaquine given with single low dose primaquine|Three day treatment with ASAQ with SLD primaquine given with the first dose of ASAQ.
15884057|NCT03773523|Device|Transcranial Direct Current Stimulation (tDCS)|tDCS will be performed with Neuroelectrics Starstim Enobio 20, a non-invasive investigational device that has been labeled as a non-significant risk device by the FDA. This study is regulated by the FDA as an Abbreviated IDE. It has built-in safety mechanisms which allow for immediate cessation of stimulation if the subject becomes uncomfortable. The current will be administered via two electrode sponges for 25 mins with 1-2 milliamperes. These administration protocols are in line with protocols that have outlined safe administration (Nitsche 2007; 2008). No side-effects have been reported with the exception of slight itching under the electrode and occasional occurrence of headache, fatigue, or nausea (Poreisz 2007). Electrodes placement: dorsolateral prefrontal cortex (DLPFC); cathode on left DLPFC, anode on right DLPFC.
15884058|NCT03773510|Drug|Trabectedin discontinuation|"Patients who did not progressed after 6 cycles of trabectedin will stop the treatment and resume drug in case of progression for other 6 cycles.
~The treatment will be resumed again at progression for other 6 cycles and this scheme of treatment will be proposed until progression under trabectedin."
15884059|NCT03773510|Drug|Trabectedin continuation|Patients who did not progressed after 6 cycles of trabectedin will continue the treatment until Progressive Disease or unacceptable toxicity
15884060|NCT03773497|Other|Common Snack Combination|Combination of Chips, Pretzels, and Popcorn.
15884061|NCT03773497|Other|Cheesy Broccoli Snack|Oven-roasted, freeze-dried, cheese flavored broccoli
15884062|NCT03773497|Other|Cheesy Broccoli with Daikon Radish Snack|Oven-roasted, freeze-dried, cheese flavored broccoli with Daikon radish powder
15884063|NCT03773497|Other|Uncooked Broccoli Snack|Uncooked, freeze-dried broccoli with ranch-type dip
15884064|NCT03773484|Behavioral|Opioid naive|Visit where the order is for an included opioid and there is no prior opioid prescription with a start date of greater than 1 day and less than 91 days
15884065|NCT03773484|Behavioral|At-risk for long term use|Visit where the order is for an included opioid, there is a prior opioid prescription with a start date greater than 1 day and less than 91 days, and there is no prior opioid prescription with a start date greater than 90 days
15894477|NCT03692923|Other|virtual community|
15884066|NCT03773484|Behavioral|Long-term opioid recipient|Total opioid doses are at least 50 MME per day, there are two or more prior opioid prescriptions with two different start dates both greater than 1 day and less than 91 days, and there is a prior opioid prescription with a start date greater than 90 days and less than 181 days
15884068|NCT03773458|Device|An artificial system for the screening of scoliosis|An artificial intelligence to make evaluation of scoliosis using back images
15884069|NCT03773445|Diagnostic Test|Golimumab trough levels|Golimumab trough levels taken immediately before the administration of the next subcutaneous dose of golimumab
15884070|NCT03773445|Diagnostic Test|Antibodies to golimumab|Antibodies to golimumab taken immediately before the administration of the next subcutaneous dose of golimumab
15884071|NCT03773445|Diagnostic Test|Histology|Histology of colonic biopsies using the Geboes Index
15884072|NCT03773445|Diagnostic Test|Colonoscopy|Colonoscopy to evaluate the endoscopic activity by a Mayo endoscopic subscore
15884073|NCT03773432|Other|Probe meal|The probe meal will be administered either in the afternoon (conventional schedule) or in the morning (unconventional schedule).
15884074|NCT03773419|Behavioral|Texting Intervention (T-WRITE)|Computer-based intervention, guided by a virtual therapist, that involves repeated listening, reading and writing sentences using a cellular phone
15884075|NCT03773419|Behavioral|HandWriting Intervention (ORLA+WTG)|Computer-based intervention, guided by a virtual therapist, that involves repeated listening, reading and writing sentences using pen and paper
15884076|NCT03773406|Device|Offline tDCS-before therapy|Direct current stimulation will be delivered using a battery-driven constant current stimulator. 2mA of direct current will be applied for 20 minutes to the angular gyrus region of the brain. We will use a standard-of-care treatment - script training - to provide speech-language therapy to our subjects. The scripting treatment will be delivered by a computer program that provides script training in an interactive conversational context.
15884077|NCT03773406|Device|Sham tDCS|Stimulation will be given for a total 30 seconds (including ramp-up and ramp-down of current) and then the tDCS device will be turned off. The brief stimulation will produce tDCS-induced sensation so that participants will not be aware when the tDCS was turned off .We will use standard-of-care treatment - script training - to provide speech-language therapy to our subjects. The scripting treatment will be delivered by a computer program that provides script training in an interactive conversational context.
15884078|NCT03773406|Device|Offline tDCS-after therapy|Direct current stimulation will be delivered using a battery-driven constant current stimulator. 2mA of direct current will be applied for 20 minutes to the angular gyrus region of the brain. We will use a standard-of-care treatment - script training - to provide speech-language therapy to our subjects. The scripting treatment will be delivered by a computer program that provides script training in an interactive conversational context.
15884079|NCT03773406|Device|Online tDCS|Direct current stimulation will be delivered using a battery-driven constant current stimulator. 2mA of direct current will be applied for 20 minutes to the angular gyrus region of the brain. We will use a standard-of-care treatment - script training - to provide speech-language therapy to our subjects. The scripting treatment will be delivered by a computer program that provides script training in an interactive conversational context.
15884080|NCT03773393|Biological|CK0801|CK0801 (a Cord blood-derived T-regulatory cell product)
15884081|NCT03773380|Combination Product|Breathe Anew Survivorship Program|The feasibility will be tested of the Breathe Anew Survivorship Program
15884082|NCT03773367|Drug|Fluorouracil|Treatment with Fluorouracil, Oxaliplatin, and Irinotecan is given for 4 cycles pre- and postoperatively, in total 8 cycles.
15884083|NCT03773367|Drug|Oxaliplatin|Treatment with Fluorouracil, Oxaliplatin, and Irinotecan is given for 4 cycles pre- and postoperatively, in total 8 cycles.
15884084|NCT03773367|Drug|Irinotecan|Treatment with Fluorouracil, Oxaliplatin, and Irinotecan is given for 4 cycles pre- and postoperatively, in total 8 cycles.
15884085|NCT03773354|Behavioral|Cognitive-behavioural therapy group for individuals with somatic symptom disorders|The intervention is a cognitive-behavioural therapy group for designed for individuals with a formal diagnosis of a somatic symptom disorder (i.e., Somatic Symptom and Related Disorders from the DSM-5) who are interested in learning self-management skills to cope with somatic symptoms and reduce emotional dysregulation, increasing their understanding of factors that contribute to somatic symptoms, and learning relaxation skills to help reduce stress.
15884086|NCT03773341|Other|research questionnaire|Patient personal data History taking clinical knee examination
15884087|NCT03773328|Biological|CK0801|CK0801 (Cord blood-derived T-regulatory cells)
15884088|NCT03773315|Dietary Supplement|UMH extract|Schisandra chinensis extract 500 mg/day for 12 weeks
15884089|NCT03773315|Dietary Supplement|Placebo|Starch placebo 500 mg/day for 12 weeks
15884090|NCT03773302|Drug|BGJ398|Infigratinib (BGJ398) 125 mg orally daily, 3 weeks on, 1 week off.
15884091|NCT03773302|Drug|Gemcitabine|Gemcitabine 1000 mg/m2 IV D1 and D8 for a 21-day cycle. Participants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib.
15884092|NCT03773302|Drug|Cisplatin|Cisplatin 25 mg/m2 IV D1 and D8 for a 21-day cycle. Participants who experience disease progression while receiving gemcitabine + cisplatin will be allowed to cross over and receive infigratinib.
15884093|NCT03773289|Other|No intervention|This is a retrospective, observational pharmacoepidemiological study using nationally collected data. There is no intervention.
15884094|NCT03773276|Drug|Norepinephrine boluses|"On portal vein declamping, We will inject NE boluses in the C.V.P port of the pulmonary artery catheter with 5 ml saline flushing after each. After reperfusion, we will start bolus noradrenaline 20 µg if mean arterial blood pressure (mABP) decreases by 10 % or more of the basal reading (immediately before portal vein declamping after ensuring withholding of the surgical manipulation). Additional NE boluses will be given as follow;
~If mABP rises to 65 mmHg (lowest target level), we will hold NE boluses.
~If mABP remains constant or begins to rise but did not reach 65 mmHg, we will give 20 µg after 10 seconds from the previous bolus
~If mABP continues to drop, we will add 10 µg to the previous dose after 10 seconds and can be repeated.
~If mABP remains below 65 mmHg more than 1 minute, we will give the scheduled bolus NE with adding 20 µg adrenaline boluses."
15884202|NCT03772431|Other|Motivational Introduction|The survey introduction was worded to include motivational content
15894478|NCT03692910|Drug|SAGE-217|SAGE-217
15884095|NCT03773263|Drug|sequential IVM system|The immature oocytes will be cultured in sequential oocyte IVM medium 1 for 6 hours (37℃, 5% CO2). After flushed 3 times, COCs were removed into sequential oocyte IVM medium 2 for further cultivation.
15884096|NCT03773263|Procedure|intracytoplasmic sperm injection (ICSI)|intracytoplasmic sperm injection (ICSI)
15884097|NCT03773263|Procedure|Thawed embryo transfer (TET)|Patients administrates oestrogen (Progynova) 3mg twice a day for 10 to 12 days. From the day when endometrium reach a thickness of 8 mm and above, luteal phase support will be given with 10 mg progesterone (Dydrogesterone Tablets,) triple per day and utrogestan (Laboratories Besins International, Paris, France) 0.2g triple per day, until 14 days after embryo transfer.
15884098|NCT03773263|Drug|traditional IVM system|COCs were aspirated and the immature oocytes will be cultured in traditional standard oocyte IVM system (Sage). 30 and 44 hours after cultivation, the maturity of oocytes will be assessed.
15884099|NCT03773250|Behavioral|Behavioral intervention|The intervention has an intensive phase and a maintenance phase.
15884100|NCT03773237|Dietary Supplement|SMOFLipid|SMOFLipid will be given to HPN patients to assess the benefits or adverse effects compared to Intralipid.
15884101|NCT03773237|Dietary Supplement|Intralipid|Intralipid will be given to HPN patients to assess the benefits or adverse effects compared to SMOFlipid
15884102|NCT03773224|Procedure|Irrigation|upon closure of the peritoneum gentamicin-saline solution (160 mg of gentamicin in 400 ml of normal saline 0.9%) will be used for irrigation of every layer of the wound before its closure
15884103|NCT03773211|Drug|Renaparin|50 mL added at one occasion ex-vivo to machine perfusion solution to treat kidney at least 3 hours prior to transplantation
15884104|NCT03773211|Drug|Placebo|50 mL added at one occasion ex-vivo to machine perfusion solution to treat kidney at least 3 hours prior to transplantation
15884105|NCT03773198|Other|Energy Resonance through Cutaneous Stimulation|"The ERCS method involves listening to the body by applying fingers to the acupuncture skin points, developed according to the energy imbalance caused by illness, pain and emotional disorders."
15884106|NCT03773198|Other|questionnaires|Measurement of anxiety-trait and state-anxiety (Spielberger), pain ( numerical scale) and satisfaction (numerical satisfaction scale)
15884107|NCT03773172|Drug|MEDI6012|MEDI6012 is recombinant human lecithin-cholesterol acyltransferase (rhLCAT), an approximately 60 kilodalton, glycosylated, single-chain protein consisting of 416 amino acids produced via Chinese hamster ovary cell culture. It is being explored as an acute treatment to reduce the risk of recurrent cardiovascular events as an adjunct to the standard of care in patients with acute myocardial infarction (MI). MEDI6012 and ACP501 have the identical amino acid sequence and are therefore considered the same molecular entity.
15884108|NCT03773172|Drug|Placebo|The placebo will mimic the active treatment.
15884109|NCT03773159|Biological|Blood sampling|4 citrated/PPACK tubes and 1 EDTA tube maximum
15884110|NCT03773146|Other|1X Airtime Incentive|An incentive given in the form of airtime
15884111|NCT03773146|Other|Lottery Airtime Incentive|An incentive given in the form of airtime
15884112|NCT03773133|Drug|Satoreotide tetraxetan|Radioactivity delivered in 2 administrations (cycles): one loading dose followed by a lower maintenance dose, 6 weeks apart until progression or unacceptable toxicity (up to 4 additional cycles could be administered depending on efficacy and tolerability).
15884113|NCT03773133|Drug|Satoreotide trizoxetan|Imaging companion: 1 administration at screening and one administration at End of core Trial cycle.
15884114|NCT03773120|Device|Using Neuromonitoring to find EBSLN|intraoperative neuromonitoring to preserving external branch of superior laryngeal nerve during thyroid surgery
15884115|NCT03773107|Drug|Carfilzomib|Irreversible proteasome inhibitor
15884116|NCT03773107|Drug|Ruxolitinib|Oral JAK inhibitor
15884117|NCT03773107|Drug|Dexamethasone|glucocorticoid
15884118|NCT03773094|Drug|Guava leaves extract|"Natural product : The leaves of the guava tree are full of antioxidants, anti-inflammatory agents, antibacterials, and even tannins that can have significant health benefits, from treating stomach troubles to chronic diseases like cancer
~•"
15884119|NCT03773094|Drug|Chlorhexidine|chemical agent used as a mouthwash against cariogenic bacteria. considered the gold standard
15884120|NCT03773081|Device|Implantation of the Magmaris scaffold|Subjects will undergo a PCI for the implantation of the Magmaris scaffold in accordance with the standard of care and standard hospital practice. Maximum of one single ACS-causing de novo lesions in one separate major epicardial vessels is allowed.
15884121|NCT03773068|Drug|BAY1817080 - Formulation A|Formulation A
15884122|NCT03773068|Drug|BAY1817080 - Formulation B|Formulation B
15884123|NCT03773068|Drug|[13C715N]-BAY 181708 stable isotope label (SIL)|0.1 mg [13C715N]-BAY181708, 15 minutes i.v. infusion at the estimated tmax after administration of Formulation B
15884124|NCT03773055|Drug|NPC-06|Patients will receive once a day for 7 days.
15884125|NCT03773042|Drug|HSK3486|For induction and maintenance of sedation.
15884126|NCT03773042|Drug|Propofol|For induction and maintenance of sedation.
15884127|NCT03773029|Dietary Supplement|soy isoflavone|100 mg soy isoflavone (as 2 capsules)
15884128|NCT03773029|Other|placebo|2 capsules of placebo
15884129|NCT03773016|Behavioral|Art apps|Participants will be split into two groups of 6 participants; each group will use one app for two weeks and then change to the other app for another 2 weeks. Participants will be supported to use the app twice a week, with a maximum of 8 individual sessions over the four weeks. The intervention will be delivered to the participants at a quiet room in the care home by two co-investigators, one will be the facilitator, and the other one will be the observer. The intervention is a 30-minutes of individual sessions, with 10 minutes of app use. The additional 20 minutes will include the setup of the equipment and preparation of the participant at the beginning of the session; and questions for the participants at the end.
15884130|NCT03773003|Dietary Supplement|Probiotics|"The administered probiotics are readily available on the market and contain
~Bifidobacterium breve, B. infantis, B. lactis, B. longum
~Lactobacillus acidophilus, L. bulgaricus, L. casei, L. crispatus, L. fermentum, L. paracasei, L. plantarum, L. reuteri, L. rhamnosus, L. salivarius
~Streptococcus thermophilus"
15884131|NCT03773003|Dietary Supplement|Placebo|Identically looking to verum, containing corn starch.
15884132|NCT03772990|Drug|Calcium Chloride|Calcium Chloride
15884133|NCT03772990|Drug|0.9% Sodium Chloride|0.9% Sodium Chloride
15884135|NCT03772964|Drug|MetFORMIN Hydrochloride ER|Subjects will be exposed to 500mg, 1000mg, or 1500mg of daily ER Metformin, by mouth, for up to 90 days. Subjects will have their venous blood sampled and baseline, throughout the trial, and following completion of their metformin exposure.
15884136|NCT03772951|Other|Cognitive Remediation Therapy|Through computer information technology, using error-free, procedural learning, speech enhancement and a series of targeted computer programmatic cognitive correction tasks, patients can gradually improve problem solving and information processing capabilities, thereby improving their recognition function.
15884137|NCT03772951|Drug|Clozapine|the course of disease is more than 2 years, the condition is stable for more than one month
15884138|NCT03772938|Biological|Stem/progenitor cells transplantation|Human autologous bone marrow-derived stem/progenitor cell transplantation administered as an intravitreal injection in patients with degenerative disease of retina.
15884139|NCT03772925|Drug|Belinostat|Given IV
15884140|NCT03772925|Drug|Pevonedistat|Given IV
15884141|NCT03772912|Device|HEMOBLAST Bellows|The HEMOBLAST™ Bellows hemostatic agent consists of a bellows pre-loaded with 1.65g of powder composed of collagen, chondroitin sulfate, and thrombin (1500 IU). HEMOBLAST™ Bellows is indicated in surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures.
15884142|NCT03772899|Drug|Fecal Microbial Transplantation|"All patients in this trial will receive FMT at least one week prior to treatment with approved immunotherapy (either pembrolizumab or nivolumab). Samples for FMT are sourced at and by the microbiology group under the supervision of Dr. Silverman at St Joseph's Hospital. Donor screening procedures are described in appendix 4. Transplant will be from one single donor for all participants unless Dr. Silverman's lab considers the need for more than one donor based on availability of donors. There will be no mixture of donor samples.
~Donor samples are manufactured into capsules according to Kao et al, 2017."
15884143|NCT03772886|Device|Peanut Ball|A peanut shaped exercise ball.
15884145|NCT03772860|Other|Pain stimulation|Pain will be simulated with an electric shock 25 mlAMP over the median nerve
15884146|NCT03772860|Other|Visual stimulation|Visual stimulation will be performed by a flicker of light on a computer screen at 15 Hrz for 0.3 seconds
15884147|NCT03772860|Other|Auditory stimulation|Auditory stimulation will be delivered through headphones with a sound at 500 Hrz at 85 decibels for 0.3 seconds
15884148|NCT03772860|Other|Mental stress|A mathematical challenge will be displayed on a computer screen that must be quickly solved
15884149|NCT03772847|Drug|ginkgolide|ginkgolide plus alteplase
15884150|NCT03772834|Behavioral|Exercise Intervention|Undergo resistance training and walking
15884151|NCT03772834|Drug|Methylphenidate|Given PO
15884152|NCT03772834|Other|Placebo|Given PO
15884153|NCT03772834|Other|Quality-of-Life Assessment|Ancillary studies
15884154|NCT03772834|Other|Questionnaire Administration|Ancillary studies
15884155|NCT03772834|Other|Stretching|Undergo stretching
15884156|NCT03772821|Other|Data collection|Between D0 and D90: local and general complications, demographic, clinical, paraclinical and biological data
15884157|NCT03772821|Other|Incision/scar measurement|Between D0 and D90
15884158|NCT03772808|Dietary Supplement|Lycocomfort|Evaluate of the perceived efficacy of LycoComfort™ supplements in alleviating symptoms associated with lower urinary tract symptoms (LUTS) and general prostate discomfort over the duration of 12 weeks intervention
15884159|NCT03772795|Other|Orthodontic Alignment|"Group 1:- Teeth alignment in this group started using round 0.014 NiTi arch wire. The 0.014 NiTi arch wire was placed into the slots of the brackets and tied with elastomers by figure of 8. During this stage, only tipping movement was applied."
15884160|NCT03772795|Other|Orthodontic Alignment|Group 2: Teeth alignment using clear aligners.
15884161|NCT03772769|Diagnostic Test|Target Enriched Multiplex PCR (TEM- PCR)|Target Enriched Multiplex PCR (TEM- PCR) assays will be performed and will probe for the typical array of advanced deep space odontogenic infections, as well as MRSA resistance, clindamycin resistance, and the presence of Panton-Valentine leukocidin (PVL) toxin, a toxin produced by some bacteria.
15884162|NCT03772769|Diagnostic Test|Microbial culture|Standard diagnosis by microbial culture.
15884163|NCT03772756|Procedure|Endoscopic ultrasound guided radiofrequency ablation|Endoscopic ultrasound guided radiofrequency ablation （EUS-RFA） will be done in 3 different sessions with 2 weeks interval between each session on Day 1, Day 15 and Day 30. Each session will involve multiple applications of EUS-RFA (up to 10) with RF setting of 25 Watts over 90 seconds for each application.
15884164|NCT03772756|Radiation|chemoradiotherapy|Receive chemoradiotherapy
15884165|NCT03772743|Other|Culprit-only revascularization|Implantation of drug eluting stents with biodegradable polymer with struts ≤65 μ in the culprit lesion of the MI. Each patient should receive revascularization with Supraflex stent or its newer versions
15884166|NCT03772743|Other|Complete functionally-guided revascularization|Implantation of drug eluting stents with biodegradable polymer with struts ≤65 μ in the culprit lesion of the MI and in all non culprit lesions with positive functional assessment. Each patient should receive revascularization with Supraflex stent or its newer versions
15884167|NCT03772717|Device|Vital EMS+|The nVNS study intervention will be delivered using a handheld electrical neuromuscular stimulator device (Vital EMS+). Participants will deliver nVNS twice per day for 60 minutes each time at least 5 days per week, for 2 years. The two electrodes for the device are placed on the left cervical (neck) region or on the left ear. Parents will be trained on where to place electrodes, how to ensure that the electrodes make a good contact with the skin, and how to set the stimulation parameters. The stimulation frequency (number of pulses) and amplitude (amount of current) will be set during the initial baseline session in the clinic at a level that prevents discomfort and does not impact cardiorespiratory parameters.
15884168|NCT03772717|Drug|Standard of Care|Patients will be asked to continue their standard medication regimens which include in most cases will involve 3 weekly infusions of intravenous immunoglobulin (IVIG) (1 gm/kg) and rarely plasma exchange (PLEX).
15884203|NCT03772431|Other|Male Voice|The survey was narrated by a male voice
15884641|NCT03769012|Dietary Supplement|Beta-Glucan|95% beta-glucan sourced from whole cell Euglena Gracilis
15884171|NCT03772678|Drug|LSALT peptide|novel 16 amino acid peptide
15884172|NCT03772678|Other|0.9% Saline|saline
15884173|NCT03772665|Drug|Emixustat|Once daily oral tablet taken for 24 months
15884174|NCT03772665|Drug|Placebo|Once daily oral tablet taken for 24 months
15884175|NCT03772652|Other|Observation|Soft tissue implant measurements
15884176|NCT03772639|Other|Shared decision making|Decision-making processes focused on the knowledge of the disease for set up adjusted care management about their necessities and engaging in recommended health behaviors
15884177|NCT03772626|Device|Heated Humidified High-flow Nasal Cannula|Patients will receive heated high humidity air through the AIRVO(TM) device starting in hospital and continuing for 60 days after hospital discharge. Oxygen will be titrated to target SpO2 between 88-92%, patients not requiring oxygen will receive heated high humidity air without oxygen. Temperature and flow rate will titrated to patient comfort with a target temperature 37 degree Celsius and flow rate of ≥20 l/minute. Patients will be encouraged to use the device overnight and when needed during the day with a target duration of at least 6 hours per night
15884178|NCT03772613|Drug|Unfractionated heparin|Administration of unfractionated heparin will be assessed using the activated clotting time
15884179|NCT03772600|Device|Dexcom G6 CGM|Use of Dexcom G6
15884182|NCT03772574|Device|Facemask preoxygenation|Standard facemask preoxygenation
15884183|NCT03772574|Device|THRIVE preoxygenation|Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
15884184|NCT03772561|Drug|AZD5363+Olaparib+Durvalumab|Patients will receive AZD5363 orally twice a day 4 days-on/ 3 days-off starting 14 days prior to cycle 1 day 1 (C1D1). Olaparib continuously twice a day at 300mg and Durvalumab intravenously at 1500mg once every 4 weeks will commence at C1D1. Treatment will continue until disease progression or the development of unacceptable toxicities.
15884185|NCT03772548|Diagnostic Test|MRI|We will examine acute (<4 weeks post SCI) to chronic (>6 months post SCI) patients using functional, structural, and metabolic MRI in both the brain and the spinal cord.
15884186|NCT03772548|Diagnostic Test|MRI|We will examine healthy control participants using functional, structural, and metabolic MRI in both the brain and the spinal cord.
15884187|NCT03772535|Diagnostic Test|Pharmacogenomics Testing|The doctor will use genetic test results to prescribe medications that are a most effective for subject.
15884188|NCT03772522|Behavioral|dk Leadership|Participants will attend two full-day workshops and four half-day group coaching sessions over the course of six weeks. The workshops and coaching sessions will be supplemented by on-line (e.g., podcasts) and print (e.g., workbooks) material. The full-day workshops will focus on identity-enhancing topics such as self-understanding, creating a life of meaning and purpose, and strategic career development. The half-day group coaching sessions will focus on workshop debriefing and on exploring solutions to transition-related challenges faced by study participants. The program was designed and carried out by dk Leadership - an established leadership and executive coaching centre in Toronto, Canada.
15884189|NCT03772509|Other|CATI|The participants in this arm were read the introduction and asked for consent by a call center employee using computer-assisted telephone interviewing and then were sent a noncommunicable disease risk factor survey via interactive voice response. This mode was used to motivate participants to complete the survey.
15884190|NCT03772496|Diagnostic Test|circulating tumor cells test|10 ml Peripheral blood are drawn from patients enrolled before surgery/FNAB and centrifuged to collect the peripheral blood mononuclear cells. Then, negative and positive immunomagnetic selections are used to exclude white blood cells and enrich tumor cells. After isolating mRNA, RT-PCR array is used to measure expression of target genes.
15884191|NCT03772496|Diagnostic Test|Fine needle aspiration biopsy|patients with potential malignant thyroid nodules are performed fine needle aspiration biopsy with the aid of ultrasound. The result of FNAB were classified by Bethesda rating system.
15884192|NCT03772483|Procedure|Local anesthesia with conventional syringe|"Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized.
~Local anesthetic infiltration speed 1ml/min. Drug: Local anaesthetic - Ubistesin - 4% Articaine with adrenaline 1: 200 000 1.7 mL"
15884193|NCT03772483|Device|Local anesthesia with conventional syringe + VR device|"Virtual reality device (Noon VR, Gear FX) is placed on the face of the patient, playing a video of soothing and peaceful natural landscapes.
~Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized.
~Local anesthetic infiltration speed 1ml/min. Drug: Local anaesthetic - Ubistesin - 4% Articaine with adrenaline 1: 200 000 1.7 mL"
15884194|NCT03772470|Other|1X airtime incentive|An incentive given in the form of airtime
15884195|NCT03772470|Other|2X airtime incentive|An incentive given in the form of airtime
15884196|NCT03772470|Other|Lottery airtime incentive|An incentive given in the form of airtime
15884197|NCT03772457|Drug|Rivaroxaban|new oral anticoagulant molecules which is the selective factor Xa inhibitor
15884198|NCT03772444|Dietary Supplement|Beetroot juice|Patients will drink 70 ml of beetroot juice daily in the week prior to surgery; the last dose will be administered via the nasogastric tube just before the start of the procedure.
15884199|NCT03772444|Dietary Supplement|Nitrate-depleted beetroot juice|Patients will drink 70 ml of nitrate-depleted beetroot juice daily in the week prior to surgery; the last dose will be administered via the nasogastric tube just before the start of the procedure.
15884200|NCT03772444|Dietary Supplement|Water|Patients will drink 70 ml of water in the week prior to surgery; the last dose will be administered via the nasogastric tube just before the start of the procedure.
15884201|NCT03772431|Other|Female Voice|The survey was narrated by a female voice
15884204|NCT03772431|Other|Informational Introduction|The survey introduction was worded to include informational content
15884205|NCT03772418|Drug|Cream Base|The formulated dosage form without ginkgo biloba or pomegranate will be applied to the 30 aging people who are suffering from wrinkles in the skin male and female. Typically, will be applied on two groups, one man (Group 0a) and one woman were (Group 0b) which they will be used plain cream.
15884206|NCT03772418|Drug|Pomegrante and Ginkgo biloba group|The extracts of ginkgo biloba and Pomegranate as formulated in topical dosage form will be applied to the 30 aging people who are suffering from wrinkles in the skin male and female. Formulated cream will be applied on two groups, one man (Group Ia)and one woman (Group Ib).
15884207|NCT03772405|Drug|Nascum Plus|nasal application of nascum plus
15884208|NCT03772405|Other|ACC|4 hours challenge to grass pollen in the allergen challenge chamber (ACC)
15884209|NCT03772392|Procedure|HPB resection|:Liver and Pancreas surgery - Compliance with ERAS protocol
15884210|NCT03772379|Device|tooth borne hyrax expander|ready made four stainless steel bands will be supported on the first premolars and first permanent molars and to which the palatal expander will be soldered to form the Hyrax,.The appliance will be activated one quarter turn per day untill reaching maximum amount of lateral expansion of the jack screw. the patients will be recalled twice per week to evaluate the progress of treatment.
15884211|NCT03772379|Procedure|microosteoperforation|"ready made four stainless steel bands supported on the first premolars and first permanent molars and to which the palatal expander will be soldered to form the Hyrax.No activation will be provided to the hyrax expander before the micro-osteoperforation is performed.
~Microosteoperforation will applied bilaterally on the buccal surface between the roots of teeth at the level of mucoginival junction, starting from the distal of canine till the distal of the first permanent molar using a small sized surgical bur mounted on a hand piece ."
15884212|NCT03772353|Drug|Letrozole|Letrozole
15884213|NCT03772353|Drug|Pyrotinib|Pyrotinib, an irreversible pan-ErbB receptor tyrosine kinase inhibitor, showed promising anti-tumour activity and acceptable tolerability in patients with HER2+ metastatic breast cancer (MBC)
15884214|NCT03772353|Drug|SHR6390|SHR6390 is a novel small molecule inhibitor specifically targeting the CDK4/6 pathway.
15884215|NCT03772340|Drug|Tradipitant|Oral capsule
15884216|NCT03772340|Drug|Placebo|Oral capsule
15884217|NCT03772327|Device|"Adheretech smart bottle"|"A smart pill bottle that measures the exact number of pills in the bottle in real-time, sends this HIPAA-compliant data to a central server, and based on the results, can remind participants to take their medication through a phone call or text message."
15884218|NCT03772327|Behavioral|Routine adherence counseling|Participants will be provided with routine adherence counseling
15884219|NCT03772314|Drug|Modafinil|Participants will received 100-400 milligrams (mg) per day of modafinil for 12 weeks.
15884220|NCT03772314|Drug|Amphetamine-Dextroamphetamine|Participants will receive 10-40 mg/day of oral amphetamine salts for 12 weeks.
15884221|NCT03772288|Drug|TAK-659|Tablets.
15884222|NCT03772288|Drug|NKTR-214|Intravenous infusion.
15884223|NCT03772275|Diagnostic Test|New york Heart Association Class II-IV|"New york Heart Association Class II-IV  study of markers"
15884224|NCT03772275|Diagnostic Test|New york Heart Association Class I|New york Heart Association Class I
15884225|NCT03772262|Dietary Supplement|goldenseal|Oral 500 mg capsules
15884226|NCT03772262|Drug|Metformin|Oral solution
15884227|NCT03772262|Drug|Furosemide|Oral solution
15884228|NCT03772262|Drug|Midazolam oral solution|Oral syrup
15884229|NCT03772262|Drug|Rosuvastatin Oral Tablet|Oral tablet
15884230|NCT03772249|Drug|DCR-HBVS|DCR-HBVS is a synthetic ribonucleic acid interference (RNAi) drug that consists of a double-stranded oligonucleotide conjugated to N-acetyl-D-galactosamine (GalNAc) ligands. DCR-HBVS is a sterile solution of the siRNA (DCR-S219) at a concentration of 195 mg/mL in water for injection (WFI).
15884231|NCT03772249|Drug|Placebo for DCR-HBVS|Sterile 9% saline for injection.
15884232|NCT03772223|Drug|Treatment A (Budesonide/Albuterol Sulfate metered dose inhaler)|Randomized participants will receive a single-dose (2 inhalations, 2 x 80/90 µg).
15884233|NCT03772223|Drug|Treatment B (Budesonide metered dose inhaler)|Randomized participants will receive a single-dose (2 inhalations, 2 x 80 µg).
15884234|NCT03772223|Drug|Treatment C (Albuterol Sulfate metered dose inhaler)|Randomized participants will receive a single-dose (2 inhalations, 2 x 90 µg).
15884235|NCT03772210|Device|tDCS|Current will be administered to subject groups as specified in arm descriptions.
15884236|NCT03772210|Other|Sham|Apparent Stimulation administered
15884237|NCT03772184|Procedure|Cervical inversion|inverting the cervical lip after delivery
15884238|NCT03772158|Drug|Cetirizine 10mg|Chewable tablet
15884239|NCT03772158|Drug|Cetirizine 10 mg|Immediate Release Tablet
15884240|NCT03772158|Drug|Cetirizine 10 mg|Immediate Release Tablet
15884241|NCT03772132|Biological|mutation and signal pathway activation status analysis Drug: FORFIRINOX|Conventional chemotherapy:5FU plus irinote- can plus oxaliplatin combination therapy
15884242|NCT03772119|Procedure|Surgical resection|Surgical resection of hemivertebra
15884243|NCT03772106|Drug|Propofol Fresenius|Propolipid 1% : IV
15884244|NCT03772106|Drug|sevorane|sevorane Quick fill (sevoflurane) : inhalation
15884245|NCT03772093|Device|Trabert current|Trabert current is an interrupted direct current of low frequency (143 Hz) applied via medium sized electrodes supported on a thick moist viscose sponge. These electrodes are placed near the spinal column along the thoracolumbar region. The electrodes are separated from each other by a distance of 3-4 cms.The current is passed through electrodes placed on the body. The intensity of the current is gradually increased short of pain. The feeling should be a pronounced but a comfortable 'tingling' sensation ('comfortably strong'). By doing this, the optimum current strength specific to the patient is found. The intensity of the current is slowly increased in the first few minutes as patients get used to the sensation. It is thought that this current provides pain relief, reduces muscle spasm and increases blood flow.
15884280|NCT03771872|Device|Virtual Prism Adaptation Therapy|Hand trajectory will deviate to the right side in the virtual reality.
15884281|NCT03771872|Device|Sham Therapy|The therapy is the same as the real virtual prism adaptation therapy, but there will be no deviation of the hand trajectory in the virtual reality.
15884246|NCT03772093|Other|Manual massage|Therapeutic massage is the manipulation of the soft tissue of whole body areas to bring about generalised improvements in health.Massage is thought to work through a mechanical action and a reflex action. A mechanical action is created by moving the muscles and soft tissues of the body using pressure and stretching movement. This mechanical action is based on breaking up fibrous tissue and loosen stiff joints.It may help heal damaged muscle, stimulate circulation, clear waste products via the lymphatic system, boost the activity of the immune system, reduce pain and tension and induce a calming effect.
15884247|NCT03772080|Other|Early counseling of prematurity in high-risk pregnancies.|Standardized information regarding prematurity, including associated complications and ways to decrease chances of preterm birth using web-based educational platform.
15884248|NCT03772067|Device|Continuous glucose monitoring CGM|The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the overall glucose levels measured with CGM installed in the arm during 14 days at baseline before diet intervention and after 14 days of the beginning of diet intervention
15884249|NCT03772067|Diagnostic Test|Clock Genes m RNA expression|The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the blood levels of Clock Genes measured at baseline and after 14 days of diet intervention
15884250|NCT03772067|Diagnostic Test|Postprandial Glucose|The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma Glucose measured at meal test after 14 days of diet intervention
15884251|NCT03772067|Diagnostic Test|Postprandial Insulin|The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma Insulin measured at meal test after 14 days of diet intervention
15884252|NCT03772067|Diagnostic Test|Plasma GLP-1|The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma GLP-1 measured at meal test after 14 days of diet intervention
15884253|NCT03772067|Diagnostic Test|DPP4 plasma activity|The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial DPP4 plasma activity measured at meal test after 14 days of diet intervention
15884254|NCT03772067|Diagnostic Test|Ghrelin|The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma Ghrelin measured at meal test after 14 days of diet intervention
15884255|NCT03772067|Diagnostic Test|Plasma CCK|The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma CCK measured at meal test after 14 days of diet intervention
15884256|NCT03772067|Diagnostic Test|Plasma PYY|The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the postprandial plasma PYY measured at meal test after 14 days of diet intervention
15884257|NCT03772067|Other|Body Weight|The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing the body weight at baseline and every weeks of diet intervention
15884258|NCT03772067|Diagnostic Test|Blood levels of HbA1c|The effect of the two diets (MBdiet and OBdiet) will be compared on the efficacy on changing blood HbA1c measured at baseline and after 90 days of diet intervention diet intervention
15884259|NCT03772054|Drug|Sevoflurane|Inhalation anesthetic agent
15884260|NCT03772054|Drug|Propofol|Intravenous anesthetic agent
15884261|NCT03772041|Drug|OPC-61815|Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg
15884262|NCT03772041|Drug|Tolvaptan Tab 15 MG|Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo
15884263|NCT03772028|Drug|cisplatin|HIPEC with cisplatin after cytoreductive surgery
15884264|NCT03772015|Diagnostic Test|Magnetic resonance imaging|MRI will be performed using a standard body spiral in the supine position with 5 mm section thickness, on the axial, coronal and sagittal planes and the diffusion weighted images acquired will be evaluated by a specialised radiologist who will be blind to the participants.
15884265|NCT03772002|Diagnostic Test|HCV screening|HCV antibody and HCV RNA surveillance, anti-HCV treatment assessment
15884266|NCT03771989|Biological|autologous, micro-fragmented adipose tissue|"The active treatment is an intra-articular injection with autologous, microfragmented adipose tissue prepared using the Lipogems system.
~Implantation of the graft is performed with the patient supine using two injections sites in order to reduce the risk of extra-articular injection."
15884267|NCT03771989|Other|Saline|The placebo is an injection with saline
15884268|NCT03771976|Procedure|Cesarean section|Risk of cesarean section between the cohorts
15884269|NCT03771976|Procedure|No cesarean section|Vaginal birth rate between the cohorts
15884270|NCT03771963|Biological|Tetravalent Dengue Vaccine (TDV)|TDV SC injection.
15884271|NCT03771950|Behavioral|Early team based neuro-rehabilitation|A structured interview will be made by OT about activity level, and an examination of the patients bodily and neurological symptoms will be made by PT. Based on this result a rehabilitation plan is established consisting of the patient's goals, and the purpose that the patient shall be as active as possible without triggering symptoms. An individual exercise program is prescribed. Between each appointment the patient will have personal tasks to accomplish with the purpose of being active based on symptoms and the adaptation to the current level of energy. The perceived symptoms will be logged. A week-schedule will be created in the purpose of helping the patient to a balanced activity level in relation to their current capacity. The PT assesses physical activity level and reactions to physical strain. Adaptations are made to the exercise program and advice is given on physical activity and exercises. When appropriate OT advices about returning to work and adaptations concerning work.
15884272|NCT03771937|Other|Education and telephone follow-up intervention|A telephone follow up and a pre-discharge education
15884273|NCT03771924|Dietary Supplement|inorganic phosphate|Sodium phosphate
15884274|NCT03771924|Dietary Supplement|placebo|Sodium chlorid
15884275|NCT03771911|Device|AED|Instructions provided by an AED
15884276|NCT03771911|Device|Telephone|Instructions provided by emergency Call Center (telephonically) with the help of an AED.
15884277|NCT03771898|Drug|SHP611|Participants will receive 150 mg of SHP611 IT via IDDD or LP once weekly for 210 weeks.
15884278|NCT03771885|Drug|BI 705564|Film-coated Tablet
15884279|NCT03771885|Drug|Placebo|Film-coated Tablet
15884468|NCT03770299|Drug|Gemcitabine|Specified dose on specified days
15884282|NCT03771846|Drug|irinotecan, oxaliplatin , fluorouracil, and leucovorin|administration of irinotecan, oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
15884283|NCT03771846|Drug|gemcitabine and oxaliplatin|administration of gemcitabine and oxaliplatin via vein
15884284|NCT03771833|Device|MARIA scan|The MARIA breast imaging system comprises of a scanning unit, housed under a patient bed. The scanning unit houses a hemispherical array, into which varying sizes of insert are fitted to ensure a close fit to the breast. The patient lies prone on the bed with their breast pendulous through an aperture in the bed and the scanning unit is risen to meet the breast. The fit is non-compressing and the scanner does not use ionising radiation.
15884285|NCT03771820|Drug|NC-6004|NC-6004 should be administered to subjects once every 3 weeks. On Day 1 of each treatment cycle NC-6004 will be administered first followed by pembrolizumab.
15884286|NCT03771820|Drug|Pembrolizumab|The recommended dose of pembrolizumab is 200 mg administered as an IV infusion over 30 minutes every 3 weeks.
15884287|NCT03771807|Dietary Supplement|Beauty From Within|one scoop of product mixed in 8-16 ounces of water consumed once daily
15884288|NCT03771807|Other|Placebo|one scoop of product mixed in 8-16 ounces of water consumed once daily
15884289|NCT03771807|Other|Facial cleansing|All subjects will use a cosmetic instrument to clean on one half of their face daily
15884290|NCT03771794|Device|ReguRate neurostimulation|"Device: ReguRate neurostimulation Device:
~Sham : ReguRate neurostimulation - mock sham stimulation mode"
15884291|NCT03771781|Drug|Empagliflozin Tablets|Observe the safty and PK after subjects receiving a single dose of Empagliflozin Tablets.
15884292|NCT03771781|Drug|Empagliflozin Tab 25 MG|Observe the safty and PK after subjects receiving a single dose of Empagliflozin Tablets( Jardiance®）.
15884293|NCT03771768|Radiation|Diode laser 980nm&100 mWatt|Diode laser 980 nm &100 milli Watt.
15884294|NCT03771768|Drug|Triamcinolone Acetonide|0.1 &5gm paste 4 times/day
15884295|NCT03771755|Drug|Ibuprofen|800 mg IV - Ibuprofen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes
15884296|NCT03771755|Drug|Acetaminophen|1000mg IV Acetaminophen every 6 hours. In case required - followed with Morphine (PCA) 1-2 mg every 5 minutes
15884297|NCT03771742|Procedure|transverse scan, in-plane, posterior-anterior TMQLB|The patients will receive the transmuscular quadratus lumborum block(TMQLB) before surgery using the transverse scan, in-plain, posterior to anterior approach. 0.6ml/kg 0.375% ropivocaine is injected when the correct needle location is confirmed.
15884298|NCT03771742|Procedure|paramedian sagittal scan, in-plane, caudal-cranial TMQLB|The patients will receive the transmuscular quadratus lumborum block(TMQLB) before surgery using the paramedic sagittal scan, in-plain, caudal-cephalic approach.0.6ml/kg 0.375% ropivocaine is injected when the correct needle location is confirmed.
15884299|NCT03771729|Drug|LCZ 696|LCZ696 200mg twice daily
15884300|NCT03771716|Behavioral|African Dance|Basic principles and guidelines for exercise programming will be followed including adequate warm-up and cool-down, progressive and gradual increments in duration, and instruction regarding avoidance of physical activity (PA) related injury. The African dance group will receive moderate intensity dance 1 hour per day, twice per week, for 6 months. The prescribed intensity will begin at light to moderate and progress to a moderate to high intensity level. Frequent assessment of heart rate and ratings of perceived exertion will ensure appropriate levels of intensity during each dance session. Levels of exertion during the dance will be prescribed and monitored based on baseline assessments of heart rate and cardiorespiratory fitness.
15884301|NCT03771716|Behavioral|African Cultural Immersion|The Culture group will participate in activities, including cooking, art and games, music, traditional crafts, and lectures and discussions about other aspects of Africana culture and customs. Topics will vary from session to session to maintain interest and engagement. The sessions will be held in a small group format and will be lead my personnel with training in each topic. Participants will meet 1 hour per day, 3 times per week, for 6 months.
15884302|NCT03771690|Behavioral|Standardised meal|A standardised meal will be consumed at 10:00 which will provide 5025 kJ energy (47% carbohydrate, 9% protein, 44% fat).
15884303|NCT03771677|Drug|Nucleotide Analog|such as Entecavir,entecavir 0.5mg per day
15884304|NCT03771677|Drug|Interferon Alfa-2A|Peginterferon alfa-2a 180ug per week
15884307|NCT03771651|Drug|Aspirin 81 mg|Subjects will take aspirin daily for 14 days leading up to surgery to determine whether it impacts inflammation of fallopian tubes.
15884308|NCT03771638|Drug|Emtricitabine / Tenofovir Disoproxil Oral Tablet|Open label daily emtricitabine/tenofovir disoproxil oral tablet
15884309|NCT03771638|Other|DOT Diary mobile app|DOT Diary mobile application for tracking medication adherence and sexual activities.
15884310|NCT03771625|Radiation|radiotherapy|whole brain with/without spinal cord
15884311|NCT03771612|Drug|Naproxen|Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)
15884312|NCT03771612|Drug|Placebos|Half of the participants will be randomly assigned to receive a placebo pill twice daily
15884313|NCT03771599|Other|Intervention Group|"Traditional massage of thirty minutes duration ( five minutes of massage was provided to all four limbs, front and back of trunk area) prior to routine physical therapy.
~Routine physical therapy comprising stretching of tight muscles ( stretch each muscle for five times with hold time of twenty seconds), Strengthening of weak muscles (perform resisted exercises ten times for each weak muscle), positioning ( how to make sitting and standing postures at home). This whole regimen was to be practiced fives times a week for a period of twelve weeks."
15884314|NCT03771599|Other|Control group|Routine physical therapy comprising stretching of tight muscles ( stretch each muscle for five times with hold time of twenty seconds), Strengthening of weak muscles (perform resisted exercises ten times for each weak muscle), positioning ( how to make sitting and standing postures at home). This whole regimen was to be practiced fives times a week for a period of twelve weeks.
15884315|NCT03771586|Drug|SAGE-718|SAGE-718 in combination with Ketamine
15884316|NCT03771586|Drug|Placebo|Placebo in combination with Ketamine
15884317|NCT03771573|Other|Physical exercise|Participants will perform physical exercises with constant, or intermittent professional supervision or will interrupt the exercise after ambulatorial physical therapy
15884469|NCT03770299|Drug|Docetaxel|Specified dose on specified days
15884318|NCT03771573|Other|monitoring|the patients will be under monitoring to investigate the evolution of the disease
15884319|NCT03771560|Drug|folinic acid|subject will take folinic acid daily for 12 weeks
15884320|NCT03771547|Diagnostic Test|ERCP|
15884321|NCT03771534|Drug|Oxygen gas|Brief maternal administration of 65-70% O2 via a face mask during the last trimester
15884322|NCT03771495|Other|Joint Mobilization|Manual Therapy Intervention, commonly used by physiotherapists
15884323|NCT03771495|Other|Laying on of Hands|Sham Hip Joint Mobilization
15884324|NCT03771482|Behavioral|Quiztime modules|Text Messaging or Email system
15884325|NCT03771469|Diagnostic Test|Sleep study|Sleep study
15884326|NCT03771456|Procedure|Colorectal resections|Colorectal resections
15884327|NCT03771443|Drug|experimental gluten free toothpaste|we prepared gluten free toothpaste in the faculty of pharmacy -Cairo university because there is no gluten free toothpaste available in the Egyptian market .
15884328|NCT03771430|Behavioral|Osteoarthritis education, exercise and CBT|"Osteoarthritis Education
~60-min session by AktivA trained PT)
~Signs/symptoms, risk factors, weight control, treatment
~Importance of physical activity
~Appropriate activity & training modalities
~Exercise and CBT Support
~60-min sessions/week for 12 weeks (a total of 24 sessions) led by AktivA and CBT trained PT)
~Warm-up session
~Strengthening exercises
~Functional exercises
~Stretching
~Monitoring of CBT progress
~Review of CBT lessons learned
~Integration of CBT skills
~Enhance motivation to continue
~Online CBT (iCBT) (10 modules completed at home)
~Pain causes & prevention
~Pain management
~Health promotion & stress reduction at home & work
~Adapting for leisure & work
~Controlling flare-ups
~Maintaining & improving results"
15884329|NCT03771430|Procedure|Total Knee Arthroplasty|Standard total knee arthroplasty will be performed.
15884330|NCT03771417|Behavioral|Exercise Intervention|The use of exercise to improve muscle and cardiometabolic health in older adults.
15884331|NCT03771404|Other|blood sampling|Patients' peripheral blood will be obtained before the surgical excision of the primary tumor as well as 1-month post-op and every 3-6 months thereafter until disease progression and upon disease relapse for the evaluation of ctDNA and CTCs. Different sites of the primary tumor as well as the regional involved lymph nodes and, in selected patients, biopsies from metastatic sites will be genotyped by NGS as well.
15884332|NCT03771391|Dietary Supplement|PKU Sphere|PKU sphere is a powdered, low phenylalanine protein substitute containing a balanced mix of casein glycomacropeptide (GMP) isolate, essential and non-essential amino acids, carbohydrate, vitamins, minerals and docosahexaenoic acid (DHA). With sugar and sweetener.
15884333|NCT03771378|Drug|rhTPO|After enrollment, all subjects receive TPO, the dose is 300 U / Kg, s.c. qd, blood routine examination is detected every 3 days during treatment. If the platelet count > 250 × 109 / L, the drug will stop until the platelet count ≤ 100 × 109 / L. Efficacy and safety will be evaluated on day 15. The evaluation criteria were based on the consensus of ITP. At the same time, all subjects will receive a mimetic (tablet), po, qd.
15884334|NCT03771378|Drug|eltrombopag|After enrollment, all subjects receive eltrombopag, the dose is 25 mg/day, po, qd. blood routine examination is detected every 3 days during treatment. If the platelet count > 250 × 109 / L, the drug will stop until the platelet count ≤ 100 × 109 / L. Efficacy and safety will be evaluated on day 15. The evaluation criteria were based on the consensus of ITP. At the same time, all subjects will give a mimetic (injection), at a dose of 300 U/Kg, s.c. qd.
15884335|NCT03771365|Procedure|Standard-PCNL|percutaneous nephrostolithotomy (PCNL) with ≥24 Fr access tract for the treatment of ≥2 cm renal stone
15884336|NCT03771365|Procedure|Mini-PCNL|percutaneous nephrostolithotomy (PCNL) with 12-20 Fr access tract for the treatment of ≥2 cm renal stone
15884337|NCT03771365|Procedure|SMP|percutaneous nephrostolithotomy (PCNL) with 10-14 Fr access tract for the treatment of ≥2 cm renal stone
15884338|NCT03771352|Device|RxSight RxLAL|The patients will be assessed for 6 months
15884339|NCT03771339|Procedure|Continuous Epidural analgesia|Continuous Epidural catheter is inserted at the Thoracic 11-T12 level, using Ropivacaine 0.375% 3 mL bolus followed by Ropivacaine 0.2% with rate 6 mL/hour for 24 hours after laparoscopic nephrectomy
15884340|NCT03771339|Procedure|Bilateral Quadratus Lumborum block|Bilateral anterior Quadratus Lumborum block using Ropivacaine 0.375% 20 mL each injection as postoperative analgesia treatment for 24 hours
15884341|NCT03771326|Biological|Kisspeptin-10|Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany)
15884342|NCT03771313|Drug|Ceftaroline|Patients will have intravenous ceftaroline dosed according to current recommendations based upon its approved usage in pediatric patients for community acquired pneumonia. Blood samples will be collected for PK/PD analysis.
15884343|NCT03771300|Behavioral|Mindfulness|This program is structured around two central elements, mindfulness and compassion. The sessions combine theory and practice components, using a methodology which priorities the reflection and debate among the students. Regarding theory component, mindfulness and compassion concepts will be set out over the length of the program, in addition to others related to time management, stress, anxiety and the balance between personal life and academic/work life. The practical component of the program consists of mindfulness and self-compassion formal and informal practices under the guidance of a specialized instructor.
15884344|NCT03771300|Behavioral|Mindfulness condition complemented by VR|"The VR is comprised of a Samsung VR goggles, a Samsung Galaxy S6 phone and optional headphones.
~In this condition, the instructor is the same as previously but the implementation of VR will be carried out by a psychologist specially trained for the application of these VR scenarios. Prior to the VR use, the psychologist will make sure about the participants´ health."
15884345|NCT03771300|Behavioral|Relaxation|This condition is based on the Progressive Muscle Relaxation.The relaxation program include training 16 muscle groups during the initial sessions, 7 muscle groups during the intermediate sessions, 4 muscle groups later and a only recall relaxation in the final session.This program is complemented with visualizations, as it was originally proposed by Jacobson (1938).
15884346|NCT03771287|Device|Oticon OpenSound Navigator speech enhancement algorithm|OpenSound Navigator (OSN) is a speech enhancement algorithm developed by Oticon. The feature is built in Oticon's current OPN™ hearing aid platform and can be adjusted and disabled in the programming. It is designed to automatically enhance speech while reducing unwanted background noise to improve communication for the user.
15884347|NCT03771287|Device|Oticon omni-directional microphone algorithm|Omni-directional microphone setups come standard for all Oticon hearing aid models. The hearing microphones have equal sensitivity across all directions.
15884348|NCT03771274|Device|Tecnis ZLB00 & Symfony IOL|The Symfony IOL will be implanted in the dominant eye while the Tecnis ZLB00 will be implanted in the non-dominant eye.
15884349|NCT03771261|Behavioral|Weight Loss|Participants will be prescribed hypo-caloric diet by a registered dietitian and attend weekly social support/nutrition education meetings.
15884350|NCT03771261|Dietary Supplement|Egg Protein|Participants will be provided pre-packaged hard-boiled eggs (3/day, medium) and egg white protein powder.
15884351|NCT03771248|Device|peek telescopic partial denture|removable partial denture
15884352|NCT03771235|Behavioral|Mindfulness-based Intervention for Tics|Psychological intervention that focuses on cultivating awareness of urges to tic and developing a different relationship to those urges through meditation and other mindfulness practices.
15884353|NCT03771235|Behavioral|Tic Information and Coping Strategies|Psychological Intervention that focuses on learning more about tics, practicing a range of strategies for coping with tics (e.g., relaxation, effective communication), and discussing challenges commonly experienced by individuals with tics.
15884354|NCT03771222|Biological|Prophylactic DLI|The G-CSF-mobilized PBSCs from cryopreserved cells of the graft were infused to the recipient at a dose of 2X10^7 CD3+ cells/kg recipient body weight. Decitabine (10 mg/m2, days 1 to 5) followed by prophylactic DLI would be given to those patients carrying TET2, DNMT3a or TP53 gene mutations.
15884355|NCT03771209|Diagnostic Test|ultrasound examination|ultrasound assessment
15884356|NCT03771196|Other|Bioactive Restorative Material|enhanced RMGIs with an ionic resin matrix, a shock-absorbing resin component, and bioactive fillers that mimic the physical and chemical properties of natural teeth
15884357|NCT03771196|Other|Resin-modified glass ionomer|Enhanced glass ionomer with acceptable mechanical properties and esthtic properties
15884358|NCT03771183|Other|Patients in long response during Halaven® treatment|Data collection
15884359|NCT03771170|Drug|Rheosorbilact®|Administered intravenously (with speed 40-60 drip per minute) at a dose of 600 to 1,000 ml (10 to 15 ml/kg body weight per 24 hours) for 3 days.
15884360|NCT03771170|Drug|Ringer lactate|Administered intravenously (with speed 40-60 drip per minute) at a dose of 1,000 to 2,500 ml (15 to 40 ml/kg body weight per 24 hours) for 3 days.
15884361|NCT03771157|Drug|Shingrix vaccine|On day one, patients will receive the first of two doses of the Shingrix vaccine will be administered as an injection into the muscle in their upper arm. The second dose of vaccine will be administered as an injection to their upper arm approximately 2 months after the first dose.
15884362|NCT03771144|Procedure|arthrolysis|Surgery is performed under general anesthesia. The usual duration of this surgery is on average 1h30. This surgery requires an anterior approach and a posterior approach. The patient is placed in lateral decubitus. The arthroscope of 2.7 is introduced by a posterior route. An anterior instrumental track is made from inside out through the rotator interval.
15884363|NCT03771131|Behavioral|Multi-domain cognitive training|Weekly sessions of multi-domain cognitive training, each lasting around one hour for an overall duration of the training of 3 months (13 sessions)
15884364|NCT03771105|Drug|phosphate|The target daily phosphate (Pi) intake is 3,500 mg/day (dietary intake plus our supplementation) for this study. Subjects will take a supplement of Pi (as KPhos Neutral 250 mg/tablet) to reach this target. Subjects will receive treatment for 30 days.
15884365|NCT03771092|Dietary Supplement|SunActive®Fe|SunActive® Fe is a colorless, odorless, tasteless iron fortifier in a powder form. This product is most commonly used to increase the amount of iron in food, beverage, and dietary supplement applications.
15884366|NCT03771092|Dietary Supplement|Lipofer®|Lipofer® is a micronized and microencapsulated source of iron, enhances the bioavailability of iron and does not taste metallic or oxidize unsaturated fats.
15884367|NCT03771092|Dietary Supplement|Intravenous ferric gluconate|Sodium ferric gluconate complex is an iron replacement product for treatment of iron deficiency anemia. The stable macromolecular complex is negatively charged at alkaline pH with an apparent molecular weight of 289,000 - 440,000 daltons on gel chromatography. It is composed of iron (III) oxide hydrate directly bonded to sucrose with a chelating gluconate function in a molar ratio of two iron molecules to one gluconate.
15884368|NCT03771066|Behavioral|bisphenol A|Vanilla wafer cookie with bisphenol A administered
15884369|NCT03771066|Behavioral|Placebo|Vanilla wafer cookie with no bisphenol A
15884370|NCT03771053|Drug|Ezetimibe with simvastatin|ezetimibe 10mg with simvastatin 40mg everyday for 12 months after PCI
15884371|NCT03771053|Drug|Simvastatin|simvastatin 40mg everyday for 12 months after PCI
15884372|NCT03771040|Drug|Masitinib|
15884373|NCT03771040|Drug|Placebo|
15884374|NCT03771027|Other|The low FODMAP diet.|The low FODMAP group had reduced the intake of FODMAP. Children received 3 main meals and 2 snacks daily prepared by the catering company according to the Human Nutrition Recommendations for Polish Population. The dietary intervention lasted four weeks.
15884375|NCT03771027|Other|The diet based on NICE guidelines.|The control group based on NICE guidelines received diet contained products with different FODMAP content. Children received 3 main meals and 2 snacks daily prepared by the catering company according to the Human Nutrition Recommendations for Polish Population. The dietary intervention lasted four weeks.
15884376|NCT03771014|Other|Early mobility|This progressive mobility pathway commenced with passive cycling within 48 hours of intubation and ventilation and progressing through assisted cycling, active cycling, bed exercises, sitting, mobilising out of bed to walking
15884377|NCT03771001|Other|Motivational Interviewing coaching and habit-building app|Coaches will use a manualized motivational interviewing approach and participants' wellness promoting changes will be supported via a habit building app that also delivers a micro-mindfulness program
15884378|NCT03770988|Drug|Treatment with Poziotinib|Treatment with Poziotinib
15884379|NCT03770975|Procedure|delayed implant with immediate provisionaliztion and soft tissue graft|delayed implant placement in the esthetic zone with immediate provisinalization and placement of a connective tissue graft buccal
15884380|NCT03770975|Procedure|delayed implant placement with immediate provisionalization|delayed implant placement with immediate provisionalization
15884381|NCT03770962|Behavioral|Two midwives|"Two midwives will be present during the active phase of the second stage and the birth of the baby. Midwife no 1 is the midwife who has been responsible for the care of the woman and midwife no 2 will assist her."
15884470|NCT03770299|Drug|Pemetrexed|Specified dose on specified days
15884382|NCT03770949|Device|3-D Printed Orthotic (Ankle Foot Orthosis)|Participants will receive a custom individual 3-D printed ankle foot orthosis (AFO).
15884383|NCT03770936|Drug|Candesartan|Candesartan 8 mg/day
15884384|NCT03770936|Drug|Ramipril|ramipril 1.25 mg/day
15884385|NCT03770923|Drug|Rupatadine|Rupatadine 10 mg daily
15884386|NCT03770923|Drug|Montelukast|Montelukast 10 mg daily
15884387|NCT03770910|Other|GIP receptor antagonist|GIP receptor antagonist
15884388|NCT03770910|Other|GIP receptor agonist|GIP(1-42)
15884389|NCT03770910|Other|Saline|Placebo (vehicle for infusions)
15884390|NCT03770897|Procedure|3D Laparoscopic Appendectomy|surgical removal of inflamed cecal appendix by 3D laparoscopic procedure
15884391|NCT03770897|Procedure|2D Laparoscopic Appendectomy|surgical removal of inflamed cecal appendix by 2D laparoscopic procedure
15884392|NCT03770871|Drug|Indirect pulp treatment using Dycal (TM)|Partial caries removal and protection of the dental pulp with biocompatible material
15884393|NCT03770871|Drug|Indirect pulp treatment using Vitrebond (TM )|Partial caries removal and protection of the dental pulp with biocompatible material
15884394|NCT03770858|Drug|Crisaborole|Subject to apply topical crisaborole twice daily to the affected atopic dermatitis areas
15884395|NCT03770858|Device|Scratch sensor|advanced, flexible and wearable skin sensor
15884396|NCT03770819|Procedure|Photodynamic therapy|"Zinc oxide gel/placebo gel will be placed into the periodontal pockets using a blunt cannula ensuring that starting from the bottom, it completely fills the periodontal pockets. The gel will be retained in the pocket for 5 minutes. The perio tip will be attached to the hand piece of the light cure unit (Wavelength: 420-480nm. Light power: 1200mw/cm2 in continuous mode) and light will be activated for 60 seconds. Following this, the pockets will be irrigated with normal saline solution (0.9%Sodium chloride).
~For groups 1 and 2, sham PDT will be performed by directing the Light cure device without turning on the light beam."
15884397|NCT03770806|Procedure|Femoral Nerve Block|Standard Ultrasound-guided peri-neural femoral nerve block with Ropivacaine 0.5% and Dexamethasone 6-8mg.
15884398|NCT03770806|Procedure|Adductor Nerve Block|Standard Ultrasound-guided peri-neural adductor nerve block, mid-thigh, with Ropivacaine 0.5% and Dexamethasone 6-8mg
15884399|NCT03770806|Other|No Block|routine iv and oral pain medication alone-observation only
15884400|NCT03770793|Procedure|Lung-sono guided|"The patient undergoing thoracic surgery is intubated with double lumen tube after induction of general anesthesia with propofol and remifentanil.
~In the intervention group, alveolar recruitment is performed to the non-surgical side of lung under examination with ultrasound just after anesthesia induction.
~During the gradual increment in the pressure of recruitment, the anesthesiologist can find the opening pressure that means the minimal pressure at which observed atelectasis starts to disappear.
~Then, alveolar recruitment is performed with the opening pressure until the atelectasis is not visible."
15884401|NCT03770780|Drug|SAGE-718|SAGE-718 in combination with Ketamine
15884402|NCT03770780|Drug|Placebo|Placebo in combination with Ketamine
15884403|NCT03770767|Drug|Faster-acting Aspart insulin Fiasp|Randomization to treatment with insulin Fiasp
15884404|NCT03770767|Drug|Control (insulin Novorapid)|Randomization to standard treatment with insulin Novorapid
15884405|NCT03770754|Procedure|Clean and shape Control group|"For the control group the root canals were prepared manually with K-files and step back technique up to size #35. For this group were administered Tylenol"
15884406|NCT03770754|Procedure|Cleand and shape Group 1|For the Group 1, LightSpeed LSX rotary instruments (Discus Dental, Culver City, CA, USA) were used to complete the canal preparation to a size #50 for the anteriors and molars to size #40. After procedures were administered Tylenol
15884407|NCT03770754|Procedure|Clean and shape Group 2|"For the group 2 the root canals were instrumented with ProTaper ﬁles using X1, X2 (21mm) to X3 (21mm). 0.5% NaOCl was used for irrigation, the original protocol suggested by ProTaper for permanent teeth was simplified for this study.
~After clinical procedures Tylenol were administered"
15884408|NCT03770741|Other|Modify cardio-respiratory support to avoid cerebral hypoxia|modification of cardio-respiratory support based on an evidence-based treatment guideline
15884409|NCT03770741|Other|Treatment as usual|Monitoring and treatment according to local guidelines and practice
15884410|NCT03770728|Drug|Efpeglenatide SAR439977|Pharmaceutical form: solution for injection Route of administration: subcutaneous
15884411|NCT03770728|Drug|Placebo|Pharmaceutical form: solution for injection Route of administration: subcutaneous
15884412|NCT03770728|Drug|Metformin|Pharmaceutical form: tablet Route of administration: oral
15884413|NCT03770728|Drug|Sulfonylurea|Pharmaceutical form: tablet Route of administration: oral
15884414|NCT03770715|Device|Respiratory polygraphy|The respiratory polygraphy consisted of continuous polygraphical recordings for a whole night from 22:00 h to 07:00 h with standardised equipment
15884415|NCT03770702|Drug|Angiotensin receptor blockers|Candesartan
15884416|NCT03770702|Drug|Statins|Atorvastatin
15884417|NCT03770689|Drug|Peposertib|Participants will receive peposertib at an escalated dose starting from 50 mg once daily 5 days per week in first cohort up to week 6 and for the next cohorts peposertib dose will be determined by the Safety Monitoring Committee (SMC) guided by a Bayesian 2-parameter logistic regression model with overdose control.
15884418|NCT03770689|Drug|Capecitabine|Participants will receive capecitabine at a dose of 825 milligram per square meter (mg/m^2) twice daily 5 days per week.
15884419|NCT03770689|Radiation|Radiotherapy (RT)|Participants will receive RT 50 to 50.4 Gray (Gy) to the tumor area and 45 Gy to the electively irradiated tissues in 25 to 28 fractions (corresponding to 5 to 5.5 weeks).
15884420|NCT03770676|Dietary Supplement|Selenium-fortified biscuits|Selenium-fortified biscuits, fortified with selenium-enriched yeast (approx. 60 mcg selenium per day, for 14 days). One of three novel flavours.
15884421|NCT03770663|Drug|Cyclophosphamide and azathioprine|European strategy 6 IV pulses of Cyclophosphamide (1000mg) followed from M5 to M12 by oral Azathioprine (2mg/kg/day), with a maximum of 150mg/day
15884422|NCT03770663|Drug|Tacrolimus|American strategy Tacrolimus given orally from M0 to M12 (started at the initial dose of 2x2mg/day). Tacrolimus doses are regularly adapted to its serum concentration to reach 5-15ng/mL.
15884423|NCT03770650|Procedure|Stenting|DK crush technique with SYNERGY (Boston Scientific) drug-eluting stent implantation.
15884471|NCT03770299|Drug|Cisplatin|Specified dose on specified days
15884424|NCT03770637|Drug|Glucagon RTU|Glucagon RTU is a sterile subcutaneous injectable non-aqueous solution formulation supplied in a vial and administered via syringe.
15884425|NCT03770637|Other|Placebo|The placebo is a non-active version of Glucagon RTU formulation, containing the same solvent and excipients (i.e., vehicle).
15884426|NCT03770624|Drug|QL-007 tablet|QL-007 will be administered orally daily over the 28 days under fasted state.
15884427|NCT03770624|Drug|TDF|TDF will be administered orally daily over the 28 days e.
15884428|NCT03770611|Dietary Supplement|Probiotic|The probiotic supplement is composed of the following bacterial strains: Bacillus coagulans, Bacillus subtilis, Bifidobacterium (B) bifidum, B. breve, B. longum, Lactobacillus (L) acidophilus, L. brevis, L. casei, L. helveticus, L. Paracasei, L plantarum, L. rhamnosus, L. salivarus, Lactococcus lactis, Pediococcus acidilactici, Pediococcus parvulus, Weisella confusa, Weisella paramesenteroides
15884429|NCT03770611|Dietary Supplement|Prebiotic|The prebiotic fiber is Agave inulin
15884430|NCT03770611|Dietary Supplement|Symbiotic|The supplement is a combination of the probiotic product + the prebiotic fiber
15884431|NCT03770611|Dietary Supplement|Placebo|The supplement is a combination of probiotic placebo and prebiotic fiber placebo. Placebo will consist on maltodextrin for both cases.
15884432|NCT03770598|Behavioral|Standard of Care Distressed in study Arm Distressed|Social worker evaluation and possible referral to Psychiatry/Psychology for evaluation and further treatment.
15884433|NCT03770598|Behavioral|Psycho-Education|Mindfulness based stress reduction class, yoga and education material
15884434|NCT03770598|Behavioral|Team Based Care|Psychiatrist, Oncologist, clinical social worker, study coordinator
15884435|NCT03770598|Behavioral|Standard of Care Non-Distressed|No psycho-education about wellness promotion or health. These patients will be monitored only.
15884436|NCT03770585|Procedure|Fluoroscopy guided Facet joint injection|Fluoroscopy guided Facet joint injection (The patient will be placed in the prone position with a pillow under the abdomen to correct the lumbar lordosis. The joint to be injected is located and marked, the x ray tube is then slowly rotated till the joint appear in profile as two parallel lines. After cleaning and drapping and administration of local anesthesia a22-g spinal needle is inserted in line with x-ray beam till bony contact is felt. All procedures will be performed under sterile conditions. Each facet joint is infiltrated with a mixture containing 0.5 ml of 0.25 % bupivacaine and 0.5 ml (20mg) methylprednisolone acetate injected into the joint.)
15884437|NCT03770585|Procedure|Ultrsound guided Facet joint injection|Ultrsound guided Facet joint injection (Patients will be placed in a prone position. The needle is inserted 1-2 cm laterally from the midline at the lateral end of the transducer and precisely positioned in the US plane at an angle of approximately 45o with respect to the axial plane)
15884438|NCT03770572|Genetic|AT-GTX-502|Subjects with diagnosis of CLN3 Batten disease will receive a single dose of AT-GTX-502 at low dose or high dose.
15884439|NCT03770559|Procedure|Minimal Invasive RAMPS|Eligible patients diagnosed as left-side pancreatic cancer in MI-RAMPS group will be treated by minimal invasive RAMPS surgery
15884440|NCT03770559|Procedure|Open RAMPS|Eligible patients diagnosed as left-side pancreatic cancer in Open-RAMPS group will be treated by open invasive RAMPS surgery
15884441|NCT03770546|Biological|Amnion Injection|Per the manufacturer, this is considered an injection of tissue/organic matter.
15884442|NCT03770546|Drug|Betamethasone injection|Routine steroid injection for these pathologies. Betamethasone Sodium Phosphate and Betamethasone Acetate injection.
15884443|NCT03770533|Other|MR-proADM guided|MR-proADM value together with routine clinical evaluation identifies patients with a low 14 day mortality risk who do not need to be hospitalized
15884444|NCT03770520|Procedure|QFR-guided CABG|CABG surgery based on CAG and QFR
15884445|NCT03770520|Procedure|Angio-guided CABG|CABG surgery based on heart team discussion of CAG
15884446|NCT03770507|Other|Exercise Training|Comparison of stationary bike and treadmill exercise among adolescents and adults
15884447|NCT03770494|Drug|LY3405105|Administered orally.
15884448|NCT03770481|Behavioral|nurse-led communication strategy|Nurse-led communication strategy (NLCS) applies 'COMFORT' framework that research nurses use the framework to engage one communication session per day with surrogates and two discussions with bedside nurses or attending physician during the ICU stay.
15884449|NCT03770468|Procedure|Blood drawl|
15884450|NCT03770455|Drug|Avelumab|Avelumab 10mg/kg every 2 weeks (Q2W) + 2nd generation ADT
15884451|NCT03770455|Drug|2nd generation ADT (abiraterone or enzalutamide)|2nd generation ADT (abiraterone or enzalutamide)
15884452|NCT03770442|Device|Cycling with FES|As described already
15884453|NCT03770442|Other|Routine physiotherapy|As described already
15884454|NCT03770429|Drug|AZD6738|MDS and CMML cells rely specifically on the ATR pathway to fix DNA damage and survive; by inhibiting ATR with AZD6738, MDS or CMML cells appear to selectively accumulate DNA damage and die, but healthy cells appear to be less sensitive to this target
15884455|NCT03770416|Drug|Ibrutinib|Given PO
15884456|NCT03770416|Biological|Nivolumab|Given IV
15884457|NCT03770403|Biological|ARGX-113|Intravenous administration of ARGX-113
15884458|NCT03770390|Procedure|Surgical correction of pectus excavatum|Surgical correction of pectus excavatum
15884459|NCT03770377|Device|Intermittent Perturbation to Continuous Perturbation|Manipulate the Movement Planning Period (MPP), by interrupting sensory predictions by removing e-stim during the inter-trial interval (Intermittent Perturbation), followed by a washout/de-adaptation period.
15884460|NCT03770377|Device|Continuous Perturbation to Intermittent Perturbation|Manipulate the Movement Planning Period (MPP), by keep sensory input about the perturbation constant by maintaining e-stim during the inter-trial interval.
15884461|NCT03770338|Drug|Teriparatide|20ug dosage daily injection, 1-month preoperative
15884462|NCT03770325|Drug|Berberine|Purified berberine (500 mg orally twice a day) in tablets for 12 weeks
15884463|NCT03770325|Drug|Placebo|Placebo tablets, prepared with the same appearance, for 12 weeks
15884464|NCT03770312|Drug|Low intensity statin|Use of low intensity statin for primary prevention of cardiovascular disease.
15884465|NCT03770312|Drug|Moderate intensity statin|Use of moderate intensity statin for primary prevention of cardiovascular disease.
15884466|NCT03770299|Biological|Nivolumab|Specified dose on specified days
15884467|NCT03770299|Drug|Vinorelbine|Specified dose on specified days
15884477|NCT03770286|Device|Floss|Floss will be used as a delivery agent of SDF to target interproximal carious lesion.
15884478|NCT03770273|Biological|Sarilumab|Sarilumab is a fully human anti-IL-6R-alpha monoclonal antibody that binds membrane-bound and soluble human IL-6R and has been shown to inhibit IL-6 signaling
15884479|NCT03770273|Other|Placebo|Placebo
15884480|NCT03770260|Drug|Ixazomib Citrate|Given PO
15884481|NCT03770260|Drug|Pevonedistat|Given IV
15884482|NCT03770247|Procedure|Intraoperative celiac plexus neurolysis|neurolysis of celiac plexus by intraoperative techniques
15884483|NCT03770247|Procedure|CT guided celiac plexus neurolysis|Neurolysis of celiac plexus percutaneously by CT guidance
15884484|NCT03770234|Drug|Transtec 35 µg/hour transdermal patch|Transdermal patch containing 20 mg buprenorphine in an active surface area of 25 squared centimeters. Buprenorphine release rate 35 µg/hour.
15884485|NCT03770221|Behavioral|CATCH|Brief, intensive case management service.
15884486|NCT03770221|Other|Financial Incentive|Financial incentive for maintaining contact with CATCH service providers.
15884487|NCT03770208|Drug|Intervention: Lidocaine|IV Lidocaine bolus plus infusion. Weight based.
15884488|NCT03770208|Drug|Control: Standard Care + Placebo|Placebo IV bolus and infusion. Weight based to mimic lidocaine volume.
15884489|NCT03770195|Device|HEMOBLAST Bellows|The HEMOBLAST™ Bellows hemostatic agent consists of a bellows pre-loaded with 1.65g of powder composed of collagen, chondroitin sulfate, and thrombin (1500 IU). HEMOBLAST™ Bellows is indicated in surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures.
15884490|NCT03770182|Device|NEUROLITH|transcranial pulse stimulation (TPS)
15884491|NCT03770156|Behavioral|Questionnaires|Overall Impression of the current state and evolution since the attacks
15884492|NCT03770143|Other|Feeding with palm olein formula|
15884493|NCT03770130|Drug|Dexmedetomidine|Dexmedetomidine, a selective α2-adrenoceptor agonist which is widely used as an adjuvant to general anaesthesia
15884494|NCT03770130|Drug|Saline|Saline, a kind of crystalloid widely used in clinical treatment
15884495|NCT03770117|Procedure|Prehabilitation|Participants who underwent Prehabilitation will have their CT scans analysed.
15884496|NCT03770117|Procedure|Standard Procedure|Patients who underwent a panctratoduodenectomy and did not receive any Prehabilitation will have their CT scans analysed and compared.
15884497|NCT03770104|Procedure|ETT insertion depth using Spanish recommendations|Infants included in this assignment group will be intubated using the formula 5.5 plus weight, when requiring oral intubation in the delivery room.
15884498|NCT03770104|Procedure|ETT insertion depth using international recommendations|Infants included in this assignment group will be intubated using the formula 6 plus weight, when requiring oral intubation in the delivery room.
15884499|NCT03770091|Drug|Theraworx|Theraworx foam applied to skin and/or compression wrap
15884500|NCT03770091|Drug|Placebo|Placebo foam
15884501|NCT03770078|Device|Test Product A|The test product is a newly developed ostomy product
15884502|NCT03770065|Device|VML-0001|Medical device
15884503|NCT03770052|Drug|duvie|take the intervention drug once daily according to the randomized groups
15884504|NCT03770039|Drug|Oral PF-06700841 containing 14C microtracer|Oral dose of 60 mg unlabeled PF-06700841 co-formulated with 30 ug 14C-labeled (300 nCi) PF-06700841 in 1st period
15884505|NCT03770039|Drug|Oral unlabeled PF-06700841|60 mg unlabeled PF-06700841 oral dose in 2nd period
15884506|NCT03770039|Drug|IV 14C-labeled PF-06700841|30 ug 14C-labeled (300 nCi) PF-06700841 intravenous infusion over 5 min in 2nd period
15884507|NCT03770026|Drug|clomiphene citrate|Clomiphene citrate-only arm: Patients will receive Clomiphene citrate induction (in a dose of 100 mg/day starting from day 3 of the cycle for 5 days). Sonographic assessment of endometrial thickness together with Power Doppler evaluation endometrial and sub-endometrial blood flow a will be done in the Day of HCG injection.
15884508|NCT03770026|Drug|Saline cervical flushing|Cervical irrigation with 1 ml of 0.9% normal saline will be done at cycle day 8 and 10 to convince patient-blinded procedure.
15884509|NCT03770026|Biological|Intrauterine Autologous platelet-rich plasma|Under complete aseptic cares and ultrasound supervision, Autologous platelet-rich plasma (0.5 - 1 ml) was immediately injected into the uterine cavity using an intrauterine insemination catheter in the cycle days 8 and 10. The Autologous platelet-rich plasma is prepared in collaboration with the Department of Clinical Pathology, Faculty of Medicine, Benha University.
15884510|NCT03770013|Drug|bupivacaine|bupivacaine 0.25% a total volume of 40 ml (20 ml each side
15884511|NCT03770013|Drug|Dexmedetomidine|Dexmedetomidine 0.5 mcg/kg
15884512|NCT03770013|Drug|clonidine|1ug/kg clonidine
15884513|NCT03770013|Drug|placebo|add placebo 9normal saline)
15884514|NCT03770000|Drug|Tenalisib|Tenalisib, BID orally daily
15884515|NCT03770000|Drug|Romidepsin|Romidepsin IV
15884516|NCT03769987|Other|observation|observe patients every 6 months
15884517|NCT03769974|Behavioral|Motor imagery|Two series of 30 seconds training of motor imagery in each manual engine gesture
15884518|NCT03769974|Behavioral|Action observation|Two series of 30 seconds training of action observation training in video format in each manual engine gesture
15884519|NCT03769974|Behavioral|Placebo intervention|Two series of 30 seconds of observation and imagination of a landscape during for each manual motor sequence
15884520|NCT03769961|Other|No intervention|No interventions - Observational study
15884521|NCT03769948|Other|risk factors for diabetic retinopathy|Demographic variables: gender, race, marital status, urban rural status. Co-morbidity variable: neuropathy, nephropathy, peripheral circulatory, ketoacidosis, hyperosmolarity Lab tests variables: alanine aminotransferase (ALT), albumin serum, anion gap, aspartate aminotransferase, blood urea nitrogen, calcium serum, chloride serum, creatinine serum, glucose serum plasma, hematocrit, hemoglobin, mean corpuscular hemoglobin concentration (MCHC), mean platelet volume (MPV), potassium serum, protein total serum, red blood cell (RBC) count, sodium serum, white blood cell (WBC) count
15884522|NCT03769935|Drug|cis Platinum, etoposide, S1|"cisplatin 75 mg/m2, iv day1, Etoposide: 60 mg/m2 IV day 1-5, every 21 days for up to 4-6 cycles.
~S1 25 mg/m2 oral, everyday until progression disease"
15884523|NCT03769922|Procedure|Extensive mesenteric resection|The mesentery is resected avoiding the root region.
15884525|NCT03769896|Drug|Nabilone 0.25 mg|capsules, 0.25 mg up to 2 mg of nabilone taken orally on a daily basis
15884526|NCT03769896|Drug|Placebo|capsule, corn starch, daily basis
15884527|NCT03769883|Behavioral|Exercise and diet|The participants will undergo diet or combined diet and exercise. The exercise will be provided at different volumes
15884528|NCT03769883|Behavioral|Diet|Dietary intervention
15884529|NCT03769870|Drug|Teneligliptin 20mg/day|cross-over
15884530|NCT03769870|Drug|Atorvastatin 40mg/Day|cross-over
15884531|NCT03769870|Drug|Teneligliptin 20mg/day + Atorvastatin 40mg/day|cross-over
15884532|NCT03769857|Dietary Supplement|NEM® + BIOCURC®|Dietary supplement combination for the support of joint health.
15884533|NCT03769857|Dietary Supplement|Placebo|Placebo
15884534|NCT03769844|Drug|GM-CSF|Subjects demonstrating immunoparalysis (defined by a whole blood ex vivo LP-induced TNF-alpha production capacity < 200 pg/ml) will receive 7 days of GM-CSF treatment by either the IV or SQ route at a dose of either 125 or 250 mcg/m2/day for 7 days.
15884535|NCT03769831|Drug|SHR2285|Ascending dose oral adminstration
15884536|NCT03769831|Drug|Placebo|Ascending dose oral adminstration
15884537|NCT03769818|Drug|bupivacaine|Bilateral TAP block with 20 ml of 0.25% bupivacaine
15884538|NCT03769818|Drug|dexamethasone|Bilateral TAP block with 4 mg/kg dexamethasone diluted with isotonic saline.
15884539|NCT03769818|Drug|placebo to dexamethasone|Bilateral TAP block with placebo to dexamethasone.
15884540|NCT03769818|Drug|placebo to bupivacaine|Bilateral TAP block with placebo to bupivacaine.
15884541|NCT03769805|Drug|Anlotinib|Anlotinib hydrochloride capsule 12 mg, orally, once a day, oral before breakfast, according to the research program for 2 weeks, discontinued for 1 week.
15884542|NCT03769792|Diagnostic Test|Blood and faeces tests|During V0 - Laboratory tests, particularly for calprotectin concentration assessment
15884543|NCT03769792|Device|Impedance spectroscopy test|During V1 - the electrical impedance of pelvic floor muscles will be measured
15884544|NCT03769792|Diagnostic Test|Full gynecological and proctological examination|During V1 - Examination with a gynecological speculum, Two-handed examination, Rectal examination and Anoscopy
15884545|NCT03769792|Diagnostic Test|Transanal ultrasonography|During V2 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.
15884546|NCT03769792|Diagnostic Test|Anorectal manometry|During V2 - reference diagnostic methods with documented effectiveness and safety; for comparison with impedance spectroscopy results.
15884547|NCT03769779|Dietary Supplement|FloraGLO Lutein|Lutein (FloraGLO™) in safflower oil
15884548|NCT03769779|Dietary Supplement|Safflower Oil|Safflower Oil
15884549|NCT03769766|Drug|Curcumin|Take medication one 500 mg pill of BCM-95 taken twice daily
15884550|NCT03769766|Drug|Placebo|Take medication one 500mg pill twice daily
15884551|NCT03769753|Device|IRE Device|For use in ablating soft tissue
15884552|NCT03769740|Device|Cerebral Oximetry|Non invasive, near infrared spectroscopy cerebral oximetry
15884553|NCT03769714|Drug|Saline Solution for Injection|Injection of 20mL of 0.9%Normal Saline
15884554|NCT03769714|Drug|Exparel|Exparel (bupivacaine liposome injectable suspension) is a liposome injection of bupivacaine, an amide-type local anesthetic, indicated (bupivacaine liposome injectable suspension) for administration into the surgical site to produce postsurgical analgesia.
15884555|NCT03769701|Procedure|self-monitoring capillary glucose (SMCG)|To measure the capillary glucose with a glucometer according to the assigned group.
15884556|NCT03769688|Drug|Cervicovaginal secretions|Same as arm descriptions
15884557|NCT03769688|Drug|Metronidazole gel|5 day course of vaginal MetroGel will be used prior to VMT intervention.
15884558|NCT03769688|Diagnostic Test|Screening tests|Diagnostic testing for a broad range of infectious pathogens in blood, vaginal swab, and urine samples, for general immunocompetence, and for potential pregnancy.
15884559|NCT03769688|Behavioral|Activities restriction|Required abstinence from sexual intercourse, usage of insertive vaginal feminine products (i.e. Tampons, menstrual cups, sex toys), other vaginal products (cleansing products, spermicides, lubricants, hygiene powders and sprays), and avoidance of behaviors including taking baths, going swimming, sitting in hot tub, or wearing thong underwear. Sanitary napkins are acceptable.
15884560|NCT03769688|Other|Sterile Saline placebo|This will be administered as a placebo in place of cervicovaginal secretions
15884561|NCT03769675|Device|High Frequency Spinal Cord Stimulator|The SCS implant will follow standard clinical practice for these FDA approved indications. Two percutaneous leads will be placed in the posterior spinal epidural space under radiographic guidance and attached to either an external stimulator (trial phase) or a subcutaneously implanted impulse generator (IPG). Intraoperative impedance testing will be performed to ensure electrical integrity. Patients with HF10 SCS will receive 30 µs pulses delivered at 10,000 Hz with amplitude adjusted to optimal analgesic response. Programming will occur postoperatively and as needed based on patient feedback in standard clinic visits. .
15884562|NCT03769662|Biological|XT-150|IL-10 transgene DNA plasmid injected into the knee synovial capsule
15884563|NCT03769649|Device|CelluTite|CelluTite: Radiofrequency-assisted lipolysis (RFAL) Morpheus8: Fractional RF
15884564|NCT03769636|Device|GaitUp Physilog 5|"The primary outcomes are measured by the Physilog 5 (physical activity) at four different periods (T1-T4). Physilog 5 is worn for 4 weeks in total.
~The secondary outcomes are fatigue, measured by FSMC (fatigue scale for motor and cognitive functions questionnaire), self-rated health-related quality of life, measured by the EQ-5D (health-questionnaire) and self-rated walking capacity, measured by the MSWS-12 (Twelve Item MS Walking Scale)."
15884565|NCT03769623|Device|Biolimus|103 subjects with small coronary artery disease who met the inclusion/exclusion criteria were enrolled, subjects were assigned to the treatment group of Biolimus
15884566|NCT03769623|Device|Powerline|103 subjects with small coronary artery disease who met the inclusion/exclusion criteria were enrolled, subjects were assigned to the treatment group of Powerline
15884567|NCT03769610|Other|Inpatient Foley catheter|
15884568|NCT03769610|Other|Outpatient Foley catheter|
15884569|NCT03769597|Drug|Iohexol Inj 300 MG/ML|After injecting a loading dose of 5ml of iohexol bolus, blood samples will be taken at given times for 24 hours. The urinary samples will be taken at each urination, with measurement of the exact volume and times
15884570|NCT03769584|Other|Follow-up questionnaire|Online- Questionnaire investigating Follow-up of Treatment Outcome, Quality of Life, Sexual Life and Partnership After Surgery of Endometriosis
15884571|NCT03769584|Other|Follow- up interview|Semi- structured Interview investigating Follow-up of Treatment Outcome, Quality of Life, Sexual Life and Partnership After Surgery of Endometriosis
15884572|NCT03769571|Behavioral|Parental coaching program at ESDM (P-ESDM)|It will have a duration of 7 months (with an inclusion period of 1 year). Parents will come to the hospital with their child once every 15 days for one-hour parental coaching sessions on the ESDM method. Home video sessions will also be performed by parents once every 15 days. Each parent will have a Certified therapist referral to the practice of ESDM and the program is framed by a certified therapist and trained in ESDM parental coaching.
15884573|NCT03769558|Other|Non-Interventional|Non-Interventional
15884574|NCT03769532|Drug|Pembrolizumab|Pembrolizumab (IMP): 200mg i.v. (fixed dose), every 3 weeks (Q3W), 8 doses
15884575|NCT03769532|Drug|Azacitidine|Azacitidine (SOC): 75 mg/m2 s.c., day 1-7 every 4 weeks (Q4W), 6 cycles
15884576|NCT03769519|Behavioral|ARICA|Personalized ARICA (AdheRence to Inhaled Corticosteroids in Asthma) intervention package.
15884577|NCT03769506|Combination Product|ASP-1929 Photoimmunotherapy|Use of ASP-1929 PIT therapy
15884578|NCT03769506|Drug|Physician's Choice SOC|docetaxel, cetuximab, methotrexate, or paclitaxel
15884579|NCT03769493|Behavioral|Mobile After-Care Support (MACS) app|The MACS app assesses and intervenes by fostering increased treatment adherence (medication/appointments) and self-coping with illness (active, planned, problem-solving focused) to reduce symptoms and improve functioning. Additionally, MACS encourages participants who are already reporting adherence and healthy coping by using positive reinforcement strategies to maintain efforts and promote additional goal setting. MACS app strategies are linked to participants' specific assessment responses, allowing for a highly personalized self-management intervention experience. The MACS app provides interactive exercises delivered by the device designed to teach patients coping skills that they can use now and in the future.
15884580|NCT03769480|Other|Muscle strength evaluation and Respiratory function Tests|Muscle strength evaluation and Respiratory function Tests
15884581|NCT03769467|Biological|tabelecleucel|Tabelecleucel is an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.
15884582|NCT03769467|Biological|pembrolizumab|pembrolizumab IV infusion
15884583|NCT03769454|Drug|PP-001|PP-001 eye drops
15884584|NCT03769454|Other|Placebo|Placebo eye drops
15884585|NCT03769441|Drug|Ferric carboxymaltose|Four intravenous dosages of ferric(III) carboxymaltose
15884586|NCT03769441|Drug|Sodium chloride|Four intravenous dosages of sodiumchloride
15884587|NCT03769428|Procedure|erector spinae plane block|The ESPB will be done in a sitting position using linear ultrasound probe (L10) of MySonoU6 machine. The blocks will be performed at the T4-T5 level of the spine using an in-plane approach. A linear probe will be placed 2-3 cm laterally to the spine using a sagittal approach. Three muscles will be identified superficial to the transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. Local anesthetic (LA) is injected between the erector spinae muscle and transverse process. Following confirmation of the correct position of the needle tip with administration of 0.5-1 ml of the fluid. Then 40cc of Ropivacaine (3.75mg/cc) will be injected .The distribution will be observed in both cranial and caudal directions.
15884588|NCT03769428|Procedure|sham erector spinae plane block|The sham ESPB will be done in a sitting position using linear ultrasound probe (L10) of MySonoU6 machine. The blocks will be performed at the T4-T5 level of the spine using an in-plane approach. A linear probe will be placed 2-3 cm laterally to the spine using a sagittal approach. Three muscles will be identified superficial to the transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. Following confirmation of the correct position of the needle tip with administration of 0.5-1 ml of the fluid a total of 40 mL of fluid will be injected next between the erector spinae muscle and transverse process. Then 40cc of normal saline will be injected.The distribution will be observed in both cranial and caudal directions.
15884589|NCT03769415|Device|Intrinsic Subtyping of Primary Breast Cancer|Primary breast tissue will be sent for Nanostring PAM50 Testing to determine intrinsic subtype
15884590|NCT03769402|Drug|Citric acid|Citric acid ph1, 50% concentration solution
15884591|NCT03769402|Drug|Control Test|Control group, xenograft was used to fill infrabony defects without treating bone surface
15884592|NCT03769389|Dietary Supplement|Birhi|"Birhi which contain the following:
~43.6g of Freeze-dried date powder+ 150g of 0% fat yoghurt"
15884593|NCT03769389|Dietary Supplement|Khassab|34.6g of freeze-dried date powder+ 150g of 0% fat yoghurt
15884594|NCT03769389|Dietary Supplement|placebo|50g of pure glucose dissolved in 100ml of water
15884595|NCT03769376|Device|Bio-Oss®|Bio-Oss® xenograft bone material will be placed into the socket following tooth extraction.
15884596|NCT03769376|Device|Salvin-Oss®|Salvin-Oss® xenograft bone material will be placed into the socket following tooth extraction.
15884597|NCT03769350|Device|Smartphone-delivered CBT for MDD|8-week Smartphone-delivered CBT for MDD. In-person cognitive-behavioral therapy (CBT) is an empirically supported treatment for MDD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral activation, and perceptual retraining/mindfulness skills.
15884598|NCT03769337|Diagnostic Test|serum biomarkers|Measurement of Serum concentrations of IL-6, TREM-1, CCL2, MMP-9, OPN, IL-1RA, GP-130, C5a, sRAGE, urokinase and presepsin before revision surgery and after 2 and 7 days after surgery
15884599|NCT03769324|Diagnostic Test|Osmolarity Test|Osmolarity Test
15884600|NCT03769311|Drug|Cetuximab|Monoclonal antibody against epidermal growth factor receptor (EGFR)
15884601|NCT03769298|Drug|Envarsus XR|The Envarsus XR® drug will be administered to study participants once daily, orally. The dosage can be 0.75 mg, 1 mg or 4 mg. The tacrolimus whole blood trough concentrations will be monitored and titrate Envarsus XR® dosage to achieve target whole blood trough concentration.
15884602|NCT03769285|Drug|Nicotinamide|Oral nicotinamide (500 mg) twice daily for at least 52 weeks
15884603|NCT03769285|Drug|Placebo oral capsule|Matching placebo taken twice daily for at least 52 weeks
15884604|NCT03769272|Procedure|Measurement of electrical delay during LV lead placement|Measurement of electrical signal in the heart during implantation of CRT, by positioning the lead in different places in the heart.
15884605|NCT03769259|Behavioral|Brief Cognitive Behavioral Therapy (BCBT)|Participants in BCBT receive 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. BCBT was is delivered in three sequential phases. In phase I (5 sessions), the therapist identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.
15884606|NCT03769259|Behavioral|Present-Centered Therapy (PCT)|Participants in PCT will receive will include 12 outpatient individual psychotherapy sessions scheduled on a weekly or biweekly basis, with the first session lasting 90 minutes and subsequent sessions lasting 60 minutes. PCT consists of (1) psychoeducation about the typical symptoms and features associated with suicidal thoughts and behaviors among military personnel; (2) normalization of symptoms; (3) experience of receipt of support and feedback from a licensed professional; and (4) positive interpersonal interactions.
15884607|NCT03769259|Behavioral|Treatment as Usual (TAU)|"All participants will receive the following interventions or procedures, regardless of treatment assignment:
~Suicide risk assessment using the Columbia Suicide Severity Rating Scale
~VA's safety planning intervention, which include Military Crisis Line contact information and lethal means access reduction
~Caring contacts and outreach via the Marine Intercept Program (MIP)
~Psychotropic medication, group therapy, substance abuse counseling, and other mental health interventions provided routinely as a part of treatment as usual"
15884608|NCT03769246|Device|Upright Go Device|Participants will be asked to use the Upright device everyday for four (4) weeks. After four (4) weeks, the participants will be asked to complete a couple of questionnaires regarding their pain scale and back posture.
15884609|NCT03769246|Other|Ergonomic Handout|Participants will be asked to use the ergonomic handout everyday for four (4) weeks. After four (4) weeks, the participants will be asked to complete a couple of questionnaires regarding their pain scale and back posture.
15884610|NCT03769233|Behavioral|Mindfulness-based Intervention|MBI will be delivered in group format, 90 minutes per week, for 5 consecutive weeks with 6-15 participants per group.
15884611|NCT03769207|Device|Ambulatory ECG|Eligible participants are asked to wear the ambulatory ECG monitor
15884612|NCT03769194|Biological|VLA15|a multivalent recombinant Outer surface protein A (OspA) based vaccine candidate
15884613|NCT03769194|Biological|Placebo|Placebo: PBS (Phosphate Buffered Saline)
15884614|NCT03769181|Drug|isatuximab SAR650984|"Pharmaceutical form: solution for infusion
~Route of administration: intravenous"
15884615|NCT03769181|Drug|cemiplimab REGN2810|"Pharmaceutical form: solution for infusion
~Route of administration: intravenous"
15884616|NCT03769168|Drug|AIN457|Secukinumab (AIN457) is a high-affinity fully human monoclonal anti- human antibody that target IL-17A and neutralizes activity.
15884617|NCT03769155|Biological|Ipilimumab|Given IV
15884618|NCT03769155|Biological|Nivolumab|Given IV
15884619|NCT03769155|Biological|VX15/2503|Given IV
15884620|NCT03769155|Procedure|Surgery|Undergo therapeutic conventional surgery
15884621|NCT03769142|Procedure|All monitoring|All monitoring (TCD, BIS, NIRS) are collected from the healthy side, contralateral to the interventional side
15884622|NCT03769129|Drug|Pembrolizumab|Pembrolizumab
15884623|NCT03769129|Procedure|microwave ablation|microwave ablation
15884624|NCT03769116|Genetic|SRP-9001|Single IV infusion of SRP-9001
15884625|NCT03769116|Genetic|Placebo|Single IV infusion of matching placebo
15884626|NCT03769103|Drug|Osimertinib|Daily oral osimertinib
15884627|NCT03769103|Radiation|Stereotactic radiotherapy|1-5 fractions of stereotactic radiotherapy
15884628|NCT03769090|Combination Product|Budesonide/albuterol sulfate metered-dose inhaler 80/180 μg|Budesonide/albuterol sulfate combination inhalation aerosol
15884629|NCT03769090|Combination Product|Budesonide/albuterol sulfate metered-dose inhaler 160/180 μg|Budesonide/albuterol sulfate combination inhalation aerosol
15884630|NCT03769090|Combination Product|Albuterol sulfate metered-dose inhaler 180 μg|Albuterol sulfate inhalation aerosol
15884631|NCT03769077|Device|Exergaming|This study involves the use of multiplayer exercise video games or 'exergames' that incorporate an avatar powered by pedaling a recumbent stationary bicycle. The Liberi suite of exergames contains six mini-games, including a combination of cooperative games, competitive games and individual games designed to be fast-paced, action-oriented, and enjoyable for youth with special needs.
15884632|NCT03769064|Drug|Placebo|Potential subjects will be screened to determine their eligibility for the study within 28 days of the first dose in the Qualification Phase (i.e., Days -28 to -2). Eligible subjects will be admitted to the clinical site on Day -1 of the Qualification Phase (Part 1) and randomized on Day 1 to receive placebo and MPH (60 mg) in 1 of 2 sequences with a 48-hour washout between dose administrations (i.e., dose administration on Days 1 and 3).
15884633|NCT03769064|Drug|Methylphenidate 60 mg|Potential subjects will be screened to determine their eligibility for the study within 28 days of the first dose in the Qualification Phase (i.e., Days -28 to -2). Eligible subjects will be admitted to the clinical site on Day -1 of the Qualification Phase (Part 1) and randomized on Day 1 to receive placebo and MPH (60 mg) in 1 of 2 sequences with a 48-hour washout between dose administrations (i.e., dose administration on Days 1 and 3).
15884634|NCT03769064|Drug|Treatment Phase Sequence 4213|Subjects will be administered single doses on Days 1, 4, 7, and 10 of the Treatment Phase.
15884635|NCT03769064|Drug|Treatment Phase Sequence 2134|Subjects will be administered single doses on Days 1, 4, 7, and 10 of the Treatment Phase.
15884636|NCT03769064|Drug|Treatment Phase Sequence 1342|Subjects will be administered single doses on Days 1, 4, 7, and 10 of the Treatment Phase.
15884637|NCT03769064|Drug|Treatment Phase Sequence 3421|Subjects will be administered single doses on Days 1, 4, 7, and 10 of the Treatment Phase.
15884638|NCT03769038|Device|chronic total occlusion|chronic total occlusion of coronary atery was opened and then stents were placed
15884639|NCT03769025|Behavioral|Suboxone Remote Observed Dosing|The remote observed dosing group will use the provided smartphone to video record themselves taking their Suboxone dose each day
15884640|NCT03769025|Other|Suboxone Attention Control|Attention control group will send a text message daily confirming that they have taken their Suboxone dose
15884643|NCT03768999|Diagnostic Test|Non-contrast magnetic resonance coronary angiography (MRCA)|Scan non-contrast MRCA and compare the image with clinically scanned coronary computed tomography angiography (CTA).
15884644|NCT03768986|Behavioral|Standard referral for HIV testing|Participants receive standard referral for HIV testing in the community.
15884645|NCT03768986|Behavioral|Online risk reduction training|Participants are encouraged to use the CDC's website to learn more about their individual risks for HIV and how to reduce them.
15884646|NCT03768986|Behavioral|Reinforcement|Systematic reinforcement of desired behaviors Participants will receive a monetary incentive for getting tested for HIV
15884647|NCT03768973|Procedure|Elective cardiac surgery|Both groups will undergo elective cardiac surgery as an intervention.
15884648|NCT03768960|Drug|Daratumumab|Participants will receive 16 mg/kg of daratumumab as IV infusion QW in Cycles 1 and 2 (Days 1, 8, 15 and 22) and Q2W in Cycle 3 to 6 (Days 1 and 15).
15884649|NCT03768947|Other|Heat therapy via hot water immersion|Participants will be asked to participate in a 4-week heat therapy intervention, which consists of ~12-15 visits (45 min each) of immersion in to a hot tub.
15884650|NCT03768934|Other|1X airtime incentive|An incentive given in the form of airtime.
15884651|NCT03768934|Other|2X airtime Incentive|An incentive given in the form of airtime.
15884652|NCT03768934|Other|Lottery airtime incentive|An incentive given in the form of airtime.
15884653|NCT03768921|Other|PEEP Titriation|The alveolar recruitment maneuver PEEP reaches a maximum of 25 cmH2O, with recruitment being performed progressively, where the pressure variation is maintained at 15 cmH2O and the PEEP increase progressively occurs at 2 cmH2O every 2 minutes and Ventilatory mode with Controlled Pressure Ventilation. After the alveolar recruitment maneuver, the PEEP titration or determination will be performed, where the PEEP of 2 cmH2O will be reduced every 2 minutes and the variables after the alveolar recruitment maneuver and PEEP maintenance will be checked in the TIMPEL brand equipment at the point where the patient has better alveolar recruitment, with fewer alveolar collapsing points and pulmonary hyperdistension.
15884654|NCT03768908|Drug|Artemether-lumefantrine|Three day treatment with Artemether-lumefantrine, 2 doses a day under direct observation
15884655|NCT03768908|Drug|Artesunate + Amodiaquine|Three day treatment with Artesunate + Amodiaquine, co-administered, a dose a day under direct observation
15884656|NCT03768895|Radiation|MRI|"The technique used was coronal and axial T1 and T2*WI sequences of the pelvis and femurs.
~The MRI machine used is a HITACHI AIRIS-II1 model, with permanent vertical magnetic field of 0.3 Tesla, and the used sequences areT1, T2*WI."
15884657|NCT03768882|Drug|paracetamol|1000 mg of paracetamol (parol 10mg/ml Mefar, Turkey) intravenous (IV) was given 102 patients
15884658|NCT03768882|Drug|Dexketoprofen|Second group: dexketoprofen 50 MG (Arveles ampoule -İE Ulagay -Menarini,Turkey) intravenous (IV) was given 98 patients
15884659|NCT03768869|Drug|Low Risk: Oupatient Management|Intravenous Levaquin initially, then oral dosing. Patient discharged to go home to finish medication cycle after initial 120 minutes observation. Patients will be evaluated daily in the clinic, and his or her temperature must be taken and recorded four times per day. Blood cultures will be drawn at clinic visits.
15884660|NCT03768869|Drug|Low Risk: Inpatient Management|Broad spectrum intravenous antibiotics. Daily blood work will be drawn, and patients will be monitored for fever and neutropenia in hospital.
15884661|NCT03768869|Drug|High Risk: Inpatient Management|Broad spectrum intravenous antibiotics. Daily blood work will be drawn, and patients will be monitored for fever and neutropenia in hospital.
15884662|NCT03768856|Radiation|Temporally Feathered Radiation Therapy (TFRT)|Up to 5 different plans are created and delivered on a daily basis Monday-Friday for 7 weeks. The treating physician designates up to 5 organs at risk (OARs) to be feathered based on the proximity to the target. The daily prescription dose delivered to the Planning Target Volumes (PTV) is not changed.
15884663|NCT03768843|Procedure|Harms technique|Atlantoaxial fusion
15884664|NCT03768830|Behavioral|Exercise training|Exercise program includes breathing and upper and lower limbs exercise.
15884665|NCT03768817|Other|No Intervention|This is a non-interventional retrospective medical record review study. No study investigational product will be administered in this protocol.
15884666|NCT03768804|Other|SyncAV algorithm on|"Cardiac Resynchronisation Device will be set to have the SyncAV algorithm on for the duration of the cardiopulmonary exercise test (CPET), before being reset to pre-existing settings"
15884667|NCT03768804|Other|SyncAV algorithm off|ardiac Resynchronisation Device will be set to have the SyncAV algorithm off and a fixed AV delay, for the duration of the CPET, before being reset to pre-existing settings
15884668|NCT03768791|Other|SCS is switched off|Spinal cord stimulator is switched off for 12 hours
15884669|NCT03768791|Other|SCS is switched on|Spinal cord stimulator is on
15884670|NCT03768778|Procedure|Debridement and dural repair|
15884671|NCT03768765|Procedure|Holmium Laser Prostate Surgery|Patients will undergo standard of care holmium laser prostate surgery
15884672|NCT03768739|Procedure|Fiberoptic Endoscopic Evaluation of Swallowing|This procedure involves a flexible laryngoscope that contains a light source and video camera on the end through the open passages of your nose and to the back of the throat in order to visualize the swallowing mechanism.
15884673|NCT03768726|Drug|Ziprasidone|All investigational products will be provided by Pfizer and will include oral ziprasidone capsules of 20, 40, 60, and 80 mg strength. Matching placebo capsules will also be supplied for the initial 1-14 day dose transition period. During the transition period all subjects will receive both active ziprasidone and placebo capsules. The placebo capsules are used to maintain the blind to the treatment assignment of the subjects in A1281198 . All medication will be packaged in childproof blister cards with columns for AM and for PM capsules. During the dose transition period (Weeks 1-2, Days 1-14), subjects will receive a study drug blister card for each week of transition dosing. Subjects weighing greater than 45 kg will receive 2 weeks of transition medication, while subjects weighing less than 45 kg will receive 1 week of transition medication.
15884741|NCT03768232|Other|ultrasound asessment|US diaphragm measurements within 36 hours of initiation of MV. Measurements will be repeated daily for the duration of MV for the first week, then every 48 hours and 24 hours after the extubation.
15884742|NCT03768219|Biological|APVO210|APVO210
15884743|NCT03768219|Biological|Placebo|Placebo is saline based IV infusion, and is identical in appearance to active study drug.
15895253|NCT03687073|Drug|Silibin|Cohort 3: 360mg
15884674|NCT03768726|Drug|Placebo|All investigational products will be provided by Pfizer and will include oral ziprasidone capsules of 20, 40, 60, and 80 mg strength. Matching placebo capsules will also be supplied for the initial 1-14 day dose transition period. During the transition period all subjects will receive both active ziprasidone and placebo capsules. The placebo capsules are used to maintain the blind to the treatment assignment of the subjects in A1281198 . All medication will be packaged in childproof blister cards with columns for AM and for PM capsules. During the dose transition period (Weeks 1-2, Days 1-14), subjects will receive a study drug blister card for each week of transition dosing. Subjects weighing greater than 45 kg will receive 2 weeks of transition medication, while subjects weighing less than 45 kg will receive 1 week of transition medication.
15884675|NCT03768713|Drug|Suvorexant|Insomnia subjects will take a nightly pill of 20 mg Suvorexant for eight weeks.
15884676|NCT03768713|Drug|Placebo|Insomnia subjects will take a nightly pill of 20 mg placebo for eight weeks.
15884677|NCT03768700|Other|Data gathering|Questionnaires and collection of medical data on patients during hospitalization, at D28, at 90 and at 1 year
15884678|NCT03768674|Other|Assessment of diagnoses, functioning and health services|Systematic differential diagnostics, assessment of psychosocial and personality functioning and treatment/ health services
15884679|NCT03768661|Procedure|Single-incision Laparoscopic cholecystectomy|laparoscopic cholecystectomy performed through a single device located at a unique umbilical incision
15884680|NCT03768661|Procedure|Laparoscopic Cholecystectomy|laparoscopic cholecystectomy performed using three-trocars standard technique
15884681|NCT03768648|Other|Clinical assessment|EDSS (Kurtzke JF; 1983) and the modified MS functional composite (MSFC) score. MS history and MS treatment will be recorded
15884682|NCT03768648|Other|Ecological evaluation|Virtual reality task : Urban DailyCog© and Actual reality
15884683|NCT03768648|Other|Neuropsychological evaluation|cognitive tests exploring information processing speed, attention/concentration, working and episodic memories and executive function
15884684|NCT03768648|Other|Psychological evaluation|questionnaires for depression, anxiety and fatigue
15884685|NCT03768648|Device|MRI Evaluation|morphological MRI and resting state functional MRI (fMRI)
15884686|NCT03768635|Other|necrotizing external otitis|description of necrotizing external otitis
15884687|NCT03768622|Procedure|surgery for pertrochanteric femoral fracture|surgical treatment for proximal femoral fracture with intramedullary nail type Gamma® Nail or similar in case of pertrochanteric fractures
15884688|NCT03768622|Procedure|surgery for femoral neck fracture|surgical treatment for proximal femoral fracture with a partial hip arthroplasty in case of femoral neck fractures
15884689|NCT03768609|Drug|Pimodivir|Participants will be administered pimodivir 600 mg orally as two tablets of 300 mg each.
15884690|NCT03768609|Drug|Cyclosporine|Participants will be administered cyclosporine 400 mg orally as 4 capsules of 100 mg each.
15884691|NCT03768596|Behavioral|Nudge|Influenza Vaccine Prescription Form accompanied on the back of telephone numbers of occupational health centers of different hospitals where interns are likely to be on probation.
15884692|NCT03768596|Other|vaccination form|a form about vaccination
15884693|NCT03768583|Other|Group TSM ICT sneakers|Sensory motor training with sneakers for volunteers with Chronic ankle instability, for five weeks, twice a week.
15884694|NCT03768583|Other|Group TSM ICT barefoot|Sensory motor training without sneakers for volunteers with Chronic ankle instability, for five weeks, twice a week.
15884695|NCT03768583|Other|Group TSM health sneaker|Sensory motor training with sneakers for volunteers with Chronic ankle instability, for five weeks, twice a week.
15884696|NCT03768583|Other|Group TSM health barefoot|Sensory motor training without sneaker for volunteers with Chronic ankle instability, for five weeks, twice a week.
15884697|NCT03768570|Drug|Durvalumab|1500 mg IV on day 1 of 4 week cycle every 4 weeks for 12 months
15884698|NCT03768557|Drug|Minocycline|Minocycline (200mg)
15884699|NCT03768557|Other|placebo|Lactose (400mg)
15884700|NCT03768544|Behavioral|Self-help guided by a lay provider|Self-help based on the principles of cognitive-behavioral therapy and guided by a lay provider. Treatment lasts 15 weeks, is based on a participant's manual, and consists of relaxation, differentiation of the main types of worries, learning to tolerate uncertainty, questioning false beliefs about worries, problem solving, cognitive exposure, and planning pleasant activities. Weekly telephone sessions with the lay provider serve to provide support.
15884701|NCT03768544|Behavioral|Waiting list where participants wait for delayed treatment|Participants have a 15-week wait period during which they receive a 15-minute telephone call from the local professional research assistant on three occasions separated by four-week intervals. The purpose of these calls is to encourage the participant to persevere until the start of treatment and to identify potential negative effects that could be associated with the waiting period. Participants receive self-help guided by a lay provider after the waiting period.
15884702|NCT03768531|Drug|Nivolumab|Nivolumab 3 mg/kg will be given intravenously (IV) through a vein in the arm over 30 minutes every 2 weeks. (Cycle length 2 weeks).
15884703|NCT03768531|Drug|Cabrilizumab|Cabiralizumab 4 mg/kg given IV for 30 minutes, 30 minutes after Nivolumab infusion is completed, every 2 weeks. (Cycle length 2 weeks).
15884704|NCT03768518|Diagnostic Test|68Ga-exendin-4 PET/CT|68Ga-exendin-4 PET/CT
15884705|NCT03768505|Drug|Zandelisib (ME-401)|Zandelisib (ME-401) 60 mg
15884706|NCT03768492|Drug|Caffeine anhydrous 5% added to Lipoderm Cream Base.|Caffeine USP Anhydrous 5 gm Ethoxy Digylco Reagent 10 ml Professional Compounding Centers of America (PCCA) Lipoderm Base 85 gm
15884707|NCT03768492|Other|Lipoderm Cream Base|Professional Compounding Centers of America (PCCA) Lipoderm Base 85 gm
15884708|NCT03768479|Device|18F-FES-PET|18F-FES-PET/CT imaging before and after cycle 1 treatment with the first line Fulvestrant
15884709|NCT03768466|Drug|Brand Name: Targin®|Brand Name: Targin® Generic name: Oxycodone/Naloxone dosage form: Oral
15884710|NCT03768440|Procedure|continuous erector spinae block (ESB)|Erector spinae block: T4/5 transverse process is identified with the ultrasound transducer in a parasagittal orientation; the needle tip is advanced until it contacts the transverse process, just below the erector spinae muscle complex; the erector spinae muscle is visualized to be elevated up off of the transverse process with normal saline injection. Following a bolus injection of 2ml/kg of 0.2% ropivacaine, a catheter is threaded into the space occupied by the local anesthetic bolus.
15884711|NCT03768440|Procedure|continuous paravertebral block (PVB)|The paravertebral space (bound medially by the bodies of the vertebrae, intervertebral discs, and intervertebral foraminae; anterolaterally by the parietal pleura and the innermost intercostal membrane; posteriorly by the transverse processes of the thoracic vertebrae, heads of the ribs, and the superior costotransverse ligament) laying between T4/5 is identified using the ultrasound transducer in a transverse orientation; the needle tip is advanced until it is seen passing under the transverse process, immediately superior to the pleura; the pleura is seen to deflect downward with normal saline injection. Following a bolus injection of 2ml/kg of 0.2% ropivacaine, a catheter is threaded into the space occupied by the local anesthetic bolus.
15884712|NCT03768440|Drug|Ropivacaine|Ropivacaine 0.2% will be the drug used for each group (ESB group and PVB group)
15884713|NCT03768427|Combination Product|EZ 10 mg/Ator 10 mg|FDC of EZ10 mg/Ator 10mg
15884714|NCT03768427|Combination Product|EZ 10 mg/Ator 20 mg|FDC of EZ10 mg/Ator 20mg
15884715|NCT03768427|Drug|Atorvastatin|Atorvastatin administered orally QD, either as two 10 mg tablets or as two 20 mg tablets
15884716|NCT03768427|Drug|Placebo for FDC EZ/Ator|A single placebo tablet administered orally QD for 84 days
15884717|NCT03768427|Drug|Placebo for atorvastatin|Two placebo tablets matching atorvastatin administered orally QD for 84 days
15884718|NCT03768414|Drug|Cisplatin|Given IV
15884719|NCT03768414|Drug|Gemcitabine Hydrochloride|Given IV
15884720|NCT03768414|Drug|Nab-paclitaxel|Given IV
15884721|NCT03768401|Other|Education|Seminars about wellness and exercise, and resulting therapeutic programs, while living with a neurological physical disability.
15884722|NCT03768401|Behavioral|Trial Exercise Modalities|Wellness/exercise clinics located at Mayo Clinic, Rochester will be offered to persons with neurological physical disabilities on a regular basis, at least monthly, during the last half of the trial period.
15884723|NCT03768388|Drug|levoketoconazole|food effect
15884724|NCT03768375|Biological|conventional chemotherapy(FORFIRINOX) combined with target agents|Drug: FORFIRINOX Conventional chemotherapy:gemcitabine and oxaliplatin Drug: Cetuximab Drug: Trastuzumab Drug: Gefitinib Drug: Lapatinib Drug: Everolimus Drug: Sorafenib Drug: Crizotinib
15884725|NCT03768375|Biological|conventional chemotherapy(FORFIRINOX)|conventional chemotherapy(FORFIRINOX)
15884726|NCT03768362|Procedure|Plication strabismus surgery|The technique was the same as resection up to muscle suturing, in the next step, the sutures were passed through 2 scleral bites at 1 mm anterior to the muscle insertion, then the muscle was folded toward inside or outside by pulling and joining the sutures. At the end, conjunctiva was repaired by vicryl 8/0.
15884727|NCT03768362|Procedure|Resection strabismus surgery|resection strabismus surgery
15884728|NCT03768349|Drug|Ga-68 PSMA11|Ga-68 PSMA11 PET/CT for detection of tumor location
15884729|NCT03768349|Drug|F-18 PSMA 1007|F-18 PSMA 1007 PET/CT for detection of tumor location
15884730|NCT03768336|Other|Waitlist control|The 3RP is a group program that-through a variety of mind-body approaches, such as imagery, relaxation, and yoga-seeks to buffer stress and promote psychological resiliency and physical well-being. Waitlist control receives the adapted 3RP program (3RP-AYA) approximately 2 months after study enrollment.
15884731|NCT03768336|Other|3RP-AYA|The 3RP is a group program that-through a variety of mind-body approaches, such as imagery, relaxation, and yoga-seeks to buffer stress and promote psychological resiliency and physical well-being.
15884732|NCT03768323|Other|1X airtime incentive|an incentive given in the form of airtime to motivate participants to complete the survey. Participants were given 50 Bangladeshi Taka ($0.60 USD) or 5000 Ugandan Shillings (UGX; $1.35 USD as of April 3, 2018) worth of airtime for completing the survey
15884733|NCT03768323|Other|2X airtime incentive|an incentive given in the form of airtime to motivate participants to complete the survey. Participants were given 100 Bangladeshi Taka ($1.20 USD) or 10000 UGX ($2.70 USD) worth of airtime for completing the survey
15884734|NCT03768310|Biological|CD19.CAR-multiVST for Group A|Patients will be evaluated in the clinic and a single dose of CD19.CAR-multiVSTs will be given by intravenous injection on or after 30 days of the transplant (between days 30 and 90). A time period of 6 weeks will constitute the time for clinical safety monitoring.
15884735|NCT03768310|Biological|CD19.CAR-multiVST for Group B|Patients will be evaluated in the clinic and a single dose of CD19.CAR-multiVSTs will be given by intravenous injection on or after 30 days of the bone marrow transplant. A time period of 6 weeks will constitute the time for clinical safety monitoring. If patients with relapse after transplant or those with evidence of disease before bone marrow transplant have at least a partial response to the treatment or have stable disease, they will be eligible to receive up to 6 additional doses of T cells separated by a minimum of four weeks. Patients are eligible to receive additional doses only after they have completed the initial 6-week clinical safety monitoring period.
15884736|NCT03768297|Procedure|dual zone concept|immediate implant with bone fill till soft tissue level
15884737|NCT03768284|Other|Saliva or buccal sample|Saliva or buccal sample
15884738|NCT03768258|Drug|Testosterone Implant|Testosterone implants or combination testosterone + anstrozole implants used to treat symptoms of hormone/androgen deficiency
15884739|NCT03768245|Behavioral|Health Education and Physical activity program|Its objective is to empower children on healthy lifestyle, addressing four main topics: nutrition (i.e. healthy food, hydration), adequate quantities of food, physical activity, and self-monitoring. The program is implemented in the classroom through workshops planned and conducted by psychologists and nutritionists. A total of 12 workshops are planned, to be conducted once a week, and lasting 50 minutes each. The Physical activity program objective is to develop an active scholar environment, and consists of a moderate-vigorous activity, five days a week. The activities are divided into two types: (a) in the school backyard for 60 minutes, three times a week, and (b) in the classroom two days a week, for 15 minutes three times a day, adding up to 45 minutes daily.
15884740|NCT03768245|Dietary Supplement|Nutrition Program|Its objective is to maintain lean mass, decrease fat mass and ensure mineral vitamins and fatty acids intake, maintain proper growth under National Specific Action Program: Food and Activity4. From total energy, a fat intake of 25-35%, carbohydrate intake of 45-65%, protein intake of 10-30%, and total calories are adjusted according to age. The Nutrition program consists of three meals: breakfast, a snack for a mid-morning playtime, and lunch at school. Food is prepared daily following sanitary and quality standards of Mexican official regulation. Breakfast is served 40 minutes before starting class time, lunch is served 40 minutes before leaving school.
15884744|NCT03768206|Behavioral|Standard Physical Therapy|Participants will receive standard outpatient physical therapy that is typical following knee replacement
15884745|NCT03768206|Behavioral|Physical therapist discuss aerobic physical activity|Physical therapists will provide recommendations to increase aerobic physical activity and set goals during standard physical therapy sessions after knee replacement.
15884746|NCT03768206|Behavioral|Physical activity session|Participants will receive a one hour coaching session on aerobic physical activity and goal setting after knee replacement.
15884747|NCT03768193|Procedure|Deep serratus anterior plane block|Deposition of local anaesthetic in the space between the serratus anterior muscle and the external intercostal muscle, at the level of the 4th-5th rib, in the midaxillary line. Procedure performed under ultrasound guidance. Catheter - based infusion of local anaesthetic into this space for 48 hours.
15884748|NCT03768193|Procedure|Surgically-placed paravertebral block|Surgically-placed paravertebral block catheters for continuous local anaesthetic infusion of 0.125% levobupivacaine at 8-12mls/ hr for 48 hours.
15884749|NCT03768167|Procedure|Posterolateral corpectomy|Investigators' goal in this study is to report clinical series of 26 patients in Sohag university hospital with dorsolumbar metastatic lesions from different primaries treated by single-stage posterolateral circumferential corpectomy with reconstruction by a pyramesh titanium cage and account the degree of improvement regarding the pain.
15884750|NCT03768154|Procedure|Supine + spontaneous effort|without muscle paralysis in supine position
15884751|NCT03768154|Procedure|Supine + paralysis|administer muscle paralysis in supine position
15884752|NCT03768154|Procedure|Prone + paralysis|change the patient position from supine to prone with muscle paralysis
15884753|NCT03768154|Procedure|Prone + spontaneous breathing|cease the paralysis in supine position
15884754|NCT03768141|Procedure|Liver surgery|"All indications (including benign and living donor resections), all co-morbidities, open, laparoscopic or robotic, single wedge resections to extended liver resections, single or two-stage hepatectomies, procedures with liver volume enhancement such as portal vein embolization (PVE), portal vein ligation (PVL), Associating Liver Partition and Portal vein Ligation for Staged hepatectomy (ALPPS), resections involving cold perfusion (ex-situ and ante-situ)"
15884755|NCT03768128|Device|Journey™ II UNI Unicompartmental Knee System|"Journey™ II UNI UKS is a CE Marked medical device. The device has been designed to treat both medial and lateral unicompartmental disease.
~It is a comprehensive system designed to allow surgeons to perform UKA. It is comprised of the following anatomic components: Oxidized zirconium femoral components Titanium tibial components with a grit-blasted surface Polyethylene tibial insert components The device is asymmetric and is available in oxidized zirconium to reduce wear and increase implant longevity."
15884756|NCT03768115|Drug|Autologous Plasma Eye Drop|Autologous plasma crimped segments
15884757|NCT03768089|Drug|VX-121|VX-121 tablet or suspension for oral administration.
15884758|NCT03768089|Drug|VX-121|VX-121 suspension for oral administration.
15884759|NCT03768089|Drug|VX-121|VX-121 tablet for oral administration.
15884760|NCT03768089|Drug|TEZ/IVA|100 milligram (mg) TEZ/150-mg IVA, fixed-dose combination (FDC) tablet for oral administration.
15884761|NCT03768089|Drug|TEZ/IVA|100 mg TEZ/150-mg IVA, FDC tablet for oral administration.
15884762|NCT03768089|Drug|IVA|150-mg film-coated tablet for oral administration.
15884763|NCT03768089|Drug|Matched Placebo|Matched placebo.
15884764|NCT03768063|Drug|Atezolizumab|Atezolizumab will be administered as a monotherapy or atezolizumab with other agent(s) or comparator agent(s) as per parent protocol. Dosing regimen will continue in accordance with the parent study or at equivalent dose (if applicable) and at the same schedule as the parent study, or switch to a fixed atezolizumab dose of 1200 mg every 3 weeks (Q3W).
15884765|NCT03768050|Other|Advanced care for frail elderly|"Home-based case management group receives advanced nursing care meeting the health and social needs of patient and/or carer. It is carried out through a process of evaluation, planning&coordination, facilitating the provision, monitoring and evaluation of the options and resources necessary for the resolution of the case. It is person-centred. The service also provides palliative care.
~Home hospitalisation/early discharge dispenses medical and nursing care at home on a transient basis after hospitalisation when patients still need surveillance and assistance. It is done in the acute, subacute or post-acute phase. In the last phase the focus is on functional recovery.
~The geriatric residences group is assisted by health care teams with expertise in geriatrics. They coordinate with primary care and health professionals of the residences to improve the attention. They are highly accessible, have high-resolutive capacity and can activate the resources of the healthcare network."
15884766|NCT03768037|Drug|Anlotinib plus Pemetrexed|"Anlotinib p.o, qd and it should be continued until disease progress or unacceptable toxic effects.
~Pemetrexed 500 mg/m2 every 21 days for 4-6 cycles or unacceptable toxic effects"
15884767|NCT03768037|Drug|Pemetrexed|Pemetrexed 500 mg/m2 every 21 days for 4-6 cycles or unacceptable toxic effects
15884768|NCT03768024|Drug|GRT0151Y 50 mg capsule|GRT0151Y 50 mg capsule
15884769|NCT03768024|Drug|Hydromorphone IR 4 mg|Hydromorphone IR 4 mg tablet (encapsulated)
15884770|NCT03768024|Drug|Matching placebo|Matching placebo
15884771|NCT03768011|Combination Product|transdermal cream and or patch|transdermal cream and/or transdermal patch(s) with or without oral medication
15884772|NCT03767998|Other|Respiratory muscle training for IMST|2 sets of 30 breaths or 6 sets of 10 repetitions with one or two minute of rest between sets, once per day, 5 days per week, training with breathing trainer.
15884773|NCT03767998|Other|Regular Rehabilitation|Regular Rehabilitation: 2-3 times a week, 6 weeks.
15884774|NCT03767998|Other|Respiratory muscle training for EMST|5 sets, 5 repetition with one or two minute of rest between sets, twice per day, 5 days per week, training with breathing trainer.
15884775|NCT03767985|Other|Dichoptic video game therapy|Dichoptic video gaming for 1 hour per week, viewed through the Oculus Rift.
15884776|NCT03767985|Other|Occlusion therapy|Occlusion therapy for 2 hours per day, 7 days a week
15884777|NCT03767972|Device|Energy-based device|Patients will receive one treatment for rejuvenation using one or multiple energy-based devices based on investigator discretion.
15884778|NCT03767959|Procedure|Chen's U-Suture|Chen's U-Suture is a new technique of the invaginated end-to-end pancreaticojejunostomy with transpancreatic transverse U-sutures
15885963|NCT03758508|Device|High Flow Oxygen nasal cannula|High Flow Oxygen nasal cannula
15884779|NCT03767959|Procedure|Classic pancreatic duct to mucosa|A Classical anastomosis technique for Pancreaticojejunostomy
15884780|NCT03767946|Diagnostic Test|Quantiferon Gold Plus Test|Small volume of whole blood incubated with specific TB antigen and then dosage of Interferon gamma production.
15884781|NCT03767933|Drug|Ibuprofen|10mg/kg, maximum 600mg; Oral liquid
15884782|NCT03767933|Drug|Acetaminophen|15mg/kg, maximum 1000mg; Oral liquid
15884783|NCT03767933|Drug|Hydromorphone|0.05mg/kg, maximum 5 mg; Oral liquid
15884784|NCT03767933|Drug|Acetaminophen placebo|Oral liquid
15884785|NCT03767933|Drug|Hydromorphone placebo|Oral liquid
15884786|NCT03767920|Drug|bupivacaine|TAP block with 20 ml of 0.25% bupivacaine bilaterally
15884787|NCT03767920|Drug|dexamethasone|TAP block with 4 mg dexamethasone bilaterally
15884788|NCT03767920|Drug|placebo to dexamethasone|TAP block with 4 mg placebo to dexamethasone bilaterally
15884789|NCT03767907|Behavioral|Computer-based Training for Cognitive Behavioural Therapy|Interactive content organized into seven modules, illustrating real-life scenarios associated with common risky situations, which illustrate the application of targeted skills and strategies
15884790|NCT03767907|Behavioral|Treatment As Usual|Treatment as usual will include standard psychosocial care determined to be appropriate or necessary, on an individual patient basis.
15884791|NCT03767894|Device|EMG Band|The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear an EMG band to control and activate the MyHand orthosis.
15884792|NCT03767894|Device|Shoulder harness|The MyHand orthosis provides tension to the digits to open the fingers on demand. This group will wear a shoulder strap to control and activate the MyHand orthosis, either with shoulder elevation or shoulder depression.
15884793|NCT03767881|Device|AXIOS(TM) Stent and Electrocautery Enhanced Delivery System|Patients who are at high risk or unsuitable for surgery will receive an AXIOS stent under EUS guidance for treatment of acute cholecystitis.
15884794|NCT03767868|Other|color change in nail polish|The determination of color change in nail polish will be based on differences in skin temperature before and after the block.
15884795|NCT03767855|Drug|CK-3773274 - Granules in Capsule|CK-3773274 formulated as granules in capsule
15884796|NCT03767855|Drug|Placebo - Granules in Capsule|Placebo formulated as granules in capsule
15884797|NCT03767855|Drug|CK-3773274 - Tablets|CK-3773274 formulated as tablets
15884798|NCT03767842|Device|Visor System|Subjects are monitored one time with the Visor System.
15884799|NCT03767829|Drug|ALN-AAT02|ALN-AAT02 will be administered subcutaneously (SC) at dose levels planned for Part A.
15884800|NCT03767829|Drug|Placebo|Sterile normal saline (0.9% NaCl) matching volume of ALN-AAT02 doses will be administered SC.
15884801|NCT03767829|Drug|ALN-AAT02|ALN-AAT02 will be administered subcutaneously (SC). Part B dose levels to be determined upon review of data from Part A.
15884802|NCT03767816|Drug|Ultrasound guided Rectus sheath block|Ultrasound guided rectus sheath block with 0.2% ropivacaine (Fresenius Kabi) 30ml around umbilicus
15884803|NCT03767816|Drug|Ultrasound erector spinae plane block|Ultrasound guided erector spinae plane block with 0.2% ropivacaine (Fresenius Kabi) 40ml at T7 level
15884804|NCT03767803|Other|Non-interventional study|This is an observational, non-interventional study.
15884805|NCT03767790|Device|iAPS|The AID system (iAPS) is comprised of an insulin pump, a Dexcom G6 continuous glucose monitoring sensor, and a smart phone that contains the algorithm and communicates with the other devices.
15884806|NCT03767777|Device|Artery Stent Graft System|The Artery Stent Graft System consists of Ankura pro Aorta Stent Graft System along with Longuette Aortic Branch Stent Graft System for chimney technique in the aim of revascularization of aorta branches.The Ankura pro aorta stent graft and Longuette Aortic Branch Stent Graft System are pre-assembled within delivery system. During the operation, the stent graft was delivered to the target lesion location of the vascular real cavity through a delivery system, which was accurately positioned and released to isolate the ruptured opening of aortic dissection, block the continuous flow of blood into the false cavity of the dissection, and avoid further tearing or even rupture of the dissection.
15884807|NCT03767764|Diagnostic Test|Test Yliver|Test Yliver is used to detect autoantibodies against alpha fetoprotein in serum by an ELISA technique
15884808|NCT03767751|Biological|Dual Specificity CD38 and bcma CAR-T Cells|1) Biological: Dual Specificity CD38 and BCMA CAR-T Cells,2)1-5X10E6/Kg
15884809|NCT03767738|Drug|Intravitreal Aflibercept Injection (IAI)|IAI prepared and administered with a pre-filled syringe (PFS)
15884810|NCT03767725|Biological|Treatment|Phase 1 Clinical Study of The patients undergo leukapheresis. The patients then receive fludarabine and cyclophosphamide on days-5 to-3. Subjects will receive (0.6-60)x10E8 transduced CART cells as a split dose over three days as follows: Day 0, 10% fraction: (0.06-6)x10E8 CART19 cells, Day 1, 30% fraction: (0.18-18)x10E8 CART19 cells, Day 2, 60% fraction: (0.36-36)x10E8 CART cells.
15884811|NCT03767712|Diagnostic Test|Comparison of the levels of antinuclear antibodies (ANA) by indirect immunofluorescence on a Hep-2 cell line.|To analyse whether patients with pertrochanteric femoral fracture with consecutive gamma-nailing develop any laboratory signs of transient autoimmunity (comparison of the levels of ANA; in order to overcome the problem of subjective semiquantitative evaluation, the novel method of automated digital fluorescence microscopy will be used)
15884812|NCT03767699|Behavioral|Medical Nutrition Therapy|MNT was offered every 2-4 weeks to all pregnant women with T2DM and GDM. Women. MNT is offered as a mandatory part of their prenatal visit and/or hospital stay. The MNT provides an individual food plan with the following recommendations: total calories should be calculated as 30 kcal/kg based on pregestational BMI for an ideal weight. Of the total energy intake 40-45% is provided by carbohydrates, a maximum of 40% is provided by lipids and the remaining percentage by proteins providing moderate-to-low glycemic index foods and fiber consumption, glucose self-monitoring, participating in 15-30 min of daily physical activity after prior authorization of the treating physician, and meeting the minimal energy requirements of pregnancy (never < 1,500 kcal).
15884813|NCT03767673|Diagnostic Test|Initial Spirometry|Determination of Vital Capacity by spirometry before (within 30 minutes) spiroergometry. Measurements will be performed in both groups.
15884814|NCT03767673|Diagnostic Test|Final Spirometry|Determination of Vital Capacity by spirometry after (within 30 minutes) spiroergometry. Measurements will be performed in both groups.
15886007|NCT03758170|Drug|Dexamethasone|An intravenous bolus dose of dexamethasone given prior to surgery.
15884815|NCT03767673|Diagnostic Test|Pulmonary microbiome (16S rDNA profiling)|Harvesting of deep induced sputum and determination of the airway microbiome by 16S ribosomal RNA (rRNA) pyrosequencing. Evaluation of alpha and beta diversity and relative bacterial abundance at the genus level. Measurements will be performed in both groups (samples will be harvested within 30 minutes after spiroergometry).
15884816|NCT03767673|Diagnostic Test|Maximum oxygen uptake|Determination of the maximum oxygen uptake (ml/kg/min) corrected for gender, age and body weight by bicycle spiroergometry. Measurements will be performed in both groups.
15884817|NCT03767673|Diagnostic Test|Maximum performance|Determination of the maximum performance (W/kg) corrected for body weight by bicycle spiroergometry. Measurements will be performed in both groups.
15884818|NCT03767673|Diagnostic Test|weight|Determined by Kilogram on a medical weight scale
15884819|NCT03767673|Other|age|Determination of age by patient's Report and past medical history
15884820|NCT03767660|Drug|Rapamycin|For children: rapamycin, 1 mg per square meter of body surface area a day, orally, for at least 6 months For adults: rapamycin, 2 mg a day, orally, for at least 6 months
15884821|NCT03767647|Behavioral|Emotional Intelligence lessons|6 lessons were given to the students in separated weeks by the same investigator. Lessons were 45-60 minutes long and each one was dedicated to one of the main aspects of emotional intelligence.
15884822|NCT03767634|Other|Parenteral nutrition|Parenteral nutrition is the administration of an intravenous solution containing amino acids (with or without lipids) to provide nutritional support.
15884823|NCT03767621|Other|Indication of revascularization|Device: iFR/FFR
15884824|NCT03767595|Device|ProACT Adjustable Continence Therapy for Men|The ProACT therapy consists of two small, adjustable silicone balloons connected with tubing to a port. During a minimally invasive outpatient procedure, the balloons are surgically placed in the area where the prostate was removed or resected.
15884825|NCT03767582|Radiation|Stereotactic Body Radiation (SBRT)|SBRT (6.6 Gy over 5 days) will be administered between 2 to 4 weeks after chemotherapy. (Prior to surgery)
15884826|NCT03767582|Drug|Nivolumab|Nivolumab (480 mg) will be administered IV over 30 minutes, on day 1 of cycle 1 (within 1 to 2 weeks after SBRT prior to surgery). Post - surgery Nivolumab will be given on Day 1 of cycles 2-5. Cycles are 4 weeks long.
15884827|NCT03767582|Drug|CCR2/CCR5 dual antagonist|CCR2/CCR5 dual antagonist (150 mg capsules) will be administered orally twice a day, on days 1-28 of cycle 1 (within 1 to 2 weeks after SBRT prior to surgery). Post - surgery CCR2/CCR5 dual antagonist will be given daily on cycles 2-5. Cycles are 4 weeks long.
15884828|NCT03767582|Drug|GVAX|Vaccine (5x10^8 cells) will be administered on day 2 of cycle 1 (within 1 to 2 weeks after SBRT prior to surgery). Post - surgery GVAX will be given on Day 2 of cycles 2-5. Cycles are 4 weeks long. Six intradermal injections every 4 weeks.
15884829|NCT03767569|Drug|Myo-inositol|Myo-inositol and Folic acid daily
15884830|NCT03767569|Drug|Folic Acid|Folic Acid daily
15884831|NCT03767556|Procedure|Inspiratory muscle training|Powerbreathe® K5
15884832|NCT03767543|Drug|INSULIN GLARGINE/LIXISENATIDE HOE901/AVE0010|Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
15884833|NCT03767530|Device|Mibo Thermoflo|Thermal therapy with Mibo Thermoflo for 11 minutes per eye, during each session.
15884834|NCT03767530|Other|Warm compresses and eyelid massage|Warm compresses plus eyelid massage 2 times per day 11 minutes per eye.
15884835|NCT03767517|Other|Active Intervention|Half of the patients will receive tele-consult program. Tele-consult intervention includes: initial consult and 2 follow up contacts. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
15884836|NCT03767517|Other|Usual Care|Half of the patients will receive usual care. Usual care includes assessment and treatment by the admitting physician, along with any subspecialists that are consulted.
15884837|NCT03767504|Dietary Supplement|Thymol|Musclin - a dietary supplement: 2 capsules (20 mg thymol per capsule) BID with a meal for 30 days increased to 4 capsules for an additional 30 days.
15884838|NCT03767491|Device|Smartphone-delivered CBT for OCD|12-week Smartphone-delivered CBT for OCD. In-person cognitive-behavioral therapy (CBT) is an empirically supported treatment for OCD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., exposure with ritual prevention), and perceptual retraining/mindfulness skills.
15884839|NCT03767478|Device|Revitive Medic (Actegy Ltd)|Twice daily use (2 x 30 minute sessions) of the footplate neuromuscular stimulation device (Revitive Medic).
15884840|NCT03767452|Drug|Xiaflex® 0.58 mg|0.25 mL injections.
15884841|NCT03767439|Drug|Vismodegib|150 mg PO daily
15884842|NCT03767439|Drug|Nivolumab|480 mg IV every 4 weeks
15884843|NCT03767439|Drug|Ipilimumab|1 mg/kg IV every 6 weeks
15884844|NCT03767426|Behavioral|Sleep Deprivation|Subjects are sleep deprived for an entire night
15884845|NCT03767426|Behavioral|Daytime nap|After a night of sleep deprivation, participants will be given a 2 hour nap opportunity
15884846|NCT03767413|Procedure|PNF|proprioceptive neuromuscular facilitation training
15884847|NCT03767413|Procedure|PNFMP|proprioceptive neuromuscular facilitation training and mental practice technique
15884848|NCT03767400|Device|Skin Imaging|Non-invasive in vivo skin imaging will be taken with the VivoSight D-OCT and the measurements will be acquired post-study utilizing VivoSight software.
15884849|NCT03767400|Other|Facial Cleanser|Participants will be instructed to remove all makeup from the face and cleanse the face with SkinMedica Facial Cleanser at least 15 minutes prior to investigator assessments and photography, and at least 30 minutes prior to use of D-OCT. Particiapnts in the cellulite group will have the thigh area cleansed with Facial Cleanser at least 15 minutes prior to photography and at least 30 minutes prior to use of D-OCT. For standardization, this procedure will be performed with SkinMedica Facial Cleanser (to remove makeup and cleanse the face and thigh (if applicable)) for all the participants.
15884850|NCT03767387|Other|Trimodal Prehabilitation|Prehabilitation before major surgery consisting of: i) motivational interview to assess patient's adherence profile and to co-design the characteristics of the physical activity program with the patient; ii) personalised program to promote daily physical activity; and iii) supervised high-intensity endurance exercise training program.
15884851|NCT03767374|Procedure|Inguinal swab sample|Inguinal samples using swab at cross-sectional visit
15886040|NCT03757923|Drug|TAB METFORMIN|INSULIN SENSITIZING AGENTS
15884852|NCT03767374|Procedure|Anal swab sample|Anal samples using swab at cross-sectional visit and at 6-month visit (for those with ESBL and/or CRE colonization)
15884853|NCT03767374|Procedure|Fecal sample|Fecal sample at cross-sectional visit and at 6-month visit (for those with ESBL and/or CRE colonization)
15884854|NCT03767374|Other|Risk factor assessment|Patients will be asked questions on risk factors associated with MDR/XDR colonization at cross-sectional visit and at 6-month visit (for those with ESBL and/or CRE colonization
15884855|NCT03767361|Biological|packed red blood cells transfusion|packed red blood cells transfusion
15884856|NCT03767348|Biological|RP1|Genetically modified herpes simplex type 1 virus
15884857|NCT03767348|Biological|nivolumab|anti-PD-1 monoclonal antibody
15884858|NCT03767335|Drug|MEN1611|MEN1611 oral dose administered twice daily for a continuous 28-day cycle
15884859|NCT03767335|Drug|Trastuzumab|Trastuzumab solution for infusion administered weekly via IV
15884860|NCT03767335|Drug|Fulvestrant|Fulvestrant solution for injection administered monthly via IM (only for HR-positive postmenopausal women)
15884861|NCT03767322|Drug|Allopurinol|Eligible patients will receive allopurinol 300 mg before and after coronary intervention
15884862|NCT03767322|Drug|Febuxostat|Eligible patients will receive febuxostat 80 mg before and after coronary intervention
15884863|NCT03767322|Drug|Placebo|Eligible patients will receive before and after coronary intervention
15884864|NCT03767309|Procedure|coronally advanced flap with abrasive de-epithelized graft.|SCTG will be harvested from the palate by abrasive de-epithelialization of palatal graft involves removing the epithelium of the selected area with a high-speed hand piece and diamond bur
15884865|NCT03767309|Procedure|coronally advanced flap with de-epithelized graft.|SCTG will be harvested from the palate by abrasive de-epithelialization of palatal graft involves removing the epithelium of the selected area with a blade
15884866|NCT03767296|Drug|Ephedrine Hydrochloride 3 MG/ML|"Bolus group, according to the randomization. Multiple boluses with incremental doses might be needed, according to the MAP ('effect titration')
~Incremental doses if needed:
~Ephedrine (E): 6 mg, 6mg, 9 mg, 9 mg, 12 mg, …..(max 24mg/bolus) A total amount of 140 mg Ephedrine will not be exceeded.
~Titrated according to the desired effect (= MAP decrease < 20%)"
15884867|NCT03767296|Drug|Phenylephrine|"Bolus group, according to the randomization. Multiple boluses with incremental doses might be needed, according to the MAP ('effect titration')
~Incremental doses if needed:
~Phenylephrine (PE): 50μg, 50μg, 100μg, 100μg, 150μg, 150μg,…(max 500µg/bolus) A total amount of 1500 μg will not be exceeded. Titrated according to the desired effect (= MAP decrease < 20%)"
15884868|NCT03767270|Biological|MRT5201|Codon-optimized human ornithine transcarbamylase messenger ribonucleic acid with lipid-based nanoparticles
15884869|NCT03767270|Other|Placebo|5% dextrose in water
15884870|NCT03767257|Drug|Colesevelam Pill|For treatment with colesevelam, the starting dose will be 1250 mg (2 x 625 mg) with food which can be increased to 6 tablets max per day based on efficacy and tolerability. Coleveselam should not be taken within 4 hours before or after lenalidomide and other interacting medications. All participants will be given a pill diary to record intake of colesevelam. The effect of colesevelam on lenalidomide-associated diarrhea will be evaluated after 1, 2, 4, 12 weeks after start of treatment. If the diarrhea does not respond to the starting dose of colesevelam, the dose can be increased every 2 days to 2 tablets two times per day (2 x 625 mg BID) and later to 3 tablets two times per day (3 x 625 mg BID). The colesevelam dose can be decrease to 1 tablet per day if there has been improvement of diarrhea but emergence of side effects.
15884871|NCT03767244|Drug|Apalutamide|Participants will receive apalutamide 240 mg (4 tablets of 60 mg each) orally once daily.
15884872|NCT03767244|Drug|Androgen Deprivation Therapy (ADT)|Participants will receive a stable regimen of ADT - gonadotropin-releasing hormone analog (agonist or antagonist) (GnRHa). ADT is a kind of hormone therapy for prostate cancer. GnRHa will be administrated to achieve and maintain sub-castrate concentrations of testosterone (50 nanogram per deciliter [ng/dL]).
15884873|NCT03767244|Drug|Placebo|Participants will receive matching placebo oral tablets daily.
15884874|NCT03767231|Diagnostic Test|Xpert HCV Viral Load Finger-stick Point-of-Care test (Cepheid)|The investigators will randomly assign eligible and consented patients to either to HCV POC VL Group or Reference Group. All participants will take a short survey regarding HCV care and treatment. As part of the investigators' ED HCV Screening and Linkage to Care Program, all participants will receive the standard-of-care clinical laboratory-based HCV RNA viral load testing via whole blood (i.e. patient will receive blood drawn). This standard-of-care HCV viral load testing result will be provided to participant when it is available (usually 1-2 days later). Participants in the HCV POC VL Group will receive the novel POC HCV RNA viral load testing and the result of the novel test will be disclosed to the patients approximately within 1 to 1½ hours of the testing.
15884875|NCT03767218|Combination Product|Late follicular phase stimulation with recombinant-human FSH|Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from day 12 of the menstrual cycle onwards. Start of GnRH antagonist (ganirelix 0.25mg/day) when serum LH > 10 IU/L, till day of trigger.
15884876|NCT03767218|Combination Product|Early follicular phase stimulation with recombinant-human FSH|Start of ovarian stimulation with recombinant-human FSH (Bemfola 225 IU daily) from day 2 of follicular phase onwards. Initiation of GnRH antagonist (ganirelix, 0.25mg/day) on stimulation day 6 till day of trigger.
15884877|NCT03767205|Device|Ankle Assist Robot|"overground walking in three conditions (with robot-torque on/with robot-torque off/without robot). During overground walking, gait function was measured using motion analysis, sEMG, and force plate
~treadmill waking in three conditions (with robot-torque on/with robot-torque off/without robot). During treadmill walking, the metabolic energy expenditure was measured using a portable cardiopulmonary metabolic system (Cosmed K4b², Rome, Italy)."
15884878|NCT03767192|Device|Active Stimulation|SPG stimulation and standard of care
15884879|NCT03767192|Device|Sham Stimulation|Sham SPG stimulation and standard of care
15884880|NCT03767179|Diagnostic Test|study|procalcitonin, sedimentation, CRP, leukocyte identification
15884881|NCT03767166|Device|Biodegradable biliary and pancreatic stents placement|Biodegradable biliary and pancreatic stents placement
15884919|NCT03766828|Procedure|inside-out-access technique with inside-out access device (Surfacer (R))|inside-out-access technique with (Surfacer (R)) with a new CE certified device (Surfacer (R), Bluegrass Vascular)
15886041|NCT03757923|Drug|TAB PIOGLITAZONE|INSULIN SENSITIZING AGENT
15884882|NCT03767153|Device|Venus Viva|"The Venus Viva™ fractional RF applicator has been shown in clinical studies to improve various skin conditions related to aging and alter collagen structures such as wrinkles, rhytids and scars.
~Beginning with the Baseline visit (Visit 1), subjects will receive a total of 3 treatments approximately 3-5 weeks apart. The left and right side of the face will be treated and assessed as independent sites, and the same applicator tip configuration will be used to treat both sides at all 3 treatment visits."
15884883|NCT03767140|Procedure|acupuncture|The patients were randomized in two groups, one verum acupuncture, submitted to real acupuncture treatment, and the other sham acupuncture, treated with false acupuncture
15884884|NCT03767114|Diagnostic Test|RT-PCR for ERAP1 detection|Reverse transcriptase -Polymerase Chain Reaction for ERAP1 detection
15884885|NCT03767101|Behavioral|Cognitive behavioral therapy|In all three treatment arms, licensed therapists/trainee therapists perform a cognitive behavior therapy (CBT) under conditions of the German health care system. All treatments are based on individualized treatment plans for each patient. Therapists are supervized by an CBT expert therapist in the outpatient treatment center. On average every forth session is supervized. The total duration of treatment is variable, oriented on patients symptoms and treatment goals.
15884886|NCT03767088|Device|WB-EMS|whole body electromyostimulation
15884887|NCT03767088|Other|(synchronized) Training program without WB-EMS|20 min of pronounced eccentric movement patterns
15884888|NCT03767075|Drug|Arm 1 - atezolizumab|Module 1 - 1200mg, IV, every 3 weeks, until progression or unacceptable toxicity develops.
15884889|NCT03767062|Drug|Topamax|An antiepileptic agent used for migraine prophylaxis.
15884890|NCT03767062|Procedure|Greater Occipital Nerve Block + Supratrochlear Nerve Block|An injection to paralyze the occipital and supratrochlear nerves.
15884891|NCT03767049|Other|Colection of clinical data|Colection of clinical data
15884892|NCT03767036|Drug|Tramadol hydrochloride 25 mg capsule|Capsule with tramadol hydrochloride 25 mg; Product of Grünenthal de Mexico S.A. de C.V.
15884893|NCT03767036|Drug|Ketorolac Tromethamine 10 mg tablet|Tablet with ketorolac tromethamine 10 mg; Product of Siegfried Rhein, S.A. de C.V., Mexico
15884894|NCT03767023|Other|cross sectional|
15884895|NCT03767010|Other|Control (no PLM)|Pre, post, delayed test Participants will perform a pretest, a posttest and a delayed test at 6 months.
15884896|NCT03767010|Other|PLM|PLM Participants will take the PLM on the location of the brachial plexus at the level of the interscalene groove on surface ultrasound images. They will also take a pretest, a post-test and a delayed test at 6 months. Pre, post, delayed test Participants will perform a pretest, a posttest and a delayed test at 6 months.
15884897|NCT03766997|Drug|Compound Betamethasone Injection|local injection
15884898|NCT03766997|Drug|Hydrocortisone Butyrate 0.1% Cream|topical use
15884899|NCT03766984|Drug|Diclofenac sodium 25 mg|Diclofenac sodium 25 mg Tablets (Laboratorios Tecnandina S.A., Ecuador)
15884900|NCT03766984|Drug|Tramadol hydrochloride 25 mg|Tramadol hydrochloride 25 mg Tablets (Laboratorios Tecnandina S.A., Ecuador)
15884901|NCT03766984|Drug|Diclofenac sodium 25 mg/Tramadol hydrochloride 25 mg|Fixed-dose combination tablet containing diclofenac sodium 25 mg and tramadol hydrochloride 25 mg (Laboratorios Tecnandina S.A., Ecuador)
15884902|NCT03766971|Behavioral|7 days of Tobacco Cessation|Participants will be randomly assigned to 7 days of tobacco cessation.
15884903|NCT03766971|Behavioral|21 days of Tobacco Cessation|Participants will be randomly assigned to 21 days of tobacco cessation.
15884904|NCT03766971|Drug|Cannabis|Participants will receive cannabis.
15884905|NCT03766919|Device|Implant of the INVICTA lead|The implant or the attempt to implant an INVICTA lead
15884906|NCT03766906|Behavioral|Talk STEM Familia app|The Talk STEM Familia app will be used to improve access to sound instruction in scientific academic vocabulary through the development of a technology-enhanced, culturally responsive smart-speaker tool that engages Latino families in culturally responsive academic language acquisition and practice in the home setting.
15884907|NCT03766893|Drug|Buprenorphine / Naloxone Oral Product|To treat opioid use disorder, buprenorphine/naloxone will be provided by a study pharmacist under a collaborative pharmacy practice agreement on a weekly (buprenorphine/naloxone) basis, unless the care plan specifies greater frequency of pharmacy visit. The median expected dose of buprenorphine/naloxone (sublingual film or tablet) is 8 to 24 mg daily, and may be adjusted per the collaborative pharmacy practice agreement.
15884908|NCT03766893|Drug|injectable naltrexone|To treat opioid use disorder, injectable naltrexone will be provided by a study pharmacist under a collaborative pharmacy practice agreement on a monthly (injectable naltrexone) basis. The expected dose of injectable naltrexone will be approximately 380 mg. Injectable naltrexone will be dispensed and prepared by the pharmacist but administered by nursing staff for the pilot study.
15884909|NCT03766893|Other|Pharmacy maintenance addiction care|Patients on a stable dose of buprenorphine/naloxone or naltrexone will receive maintenance care at the pharmacy for one month. Patients will visit weekly for check-ins with a pharmacist. Patients on buprenorphine/naloxone will be dispensed their medication at study visits, whereas patients taking injectable naltrexone will be dispensed it once by the pharmacist during the pilot. All patients will visit the pharmacy at least weekly for addiction care (assessment, toxicological testing).
15884910|NCT03766880|Procedure|Transjugular HVPG measurement|By means of catheterization of a hepatic vein with a balloon catheter.
15884911|NCT03766880|Procedure|MR imaging|MR images for the post-processing analysis
15884912|NCT03766867|Drug|Vortioxetine infusion 25 mg|1 mg/mL, concentrate for solution for infusion, 25 mL (25 mg) administered in 250 mL saline over 2 hours as single dose for 7 days
15884913|NCT03766867|Drug|Vortioxetine tablets 10 mg/day|10 mg, tablets, oral administration once daily
15884914|NCT03766867|Drug|Placebo infusion|concentrate for solution for infusion, 25 mL administered in 250 mL saline over 2 hours as single dose
15884915|NCT03766867|Drug|Placebo tablets|oral administration once daily
15884916|NCT03766854|Drug|insulin icodec|Participants will receive subcutaneous (s.c.) injections of insulin 287 once weekly for 8 weeks
15884917|NCT03766854|Drug|Insulin glargine U100|Participants will receive s.c. injections of insulin glargine once weekly for 2 weeks
15884918|NCT03766841|Behavioral|Facilitated Enrollment|Research coordinator will assist patients in account creation and usage of the tool.
15885579|NCT03761394|Device|Kardia Mobile by AliveCor|Mobile ECG device for comparison of testing devices during the extended use period.
15884920|NCT03766828|Procedure|access technique including Sharp recanalization|access technique with Sharp recanalization via interventional radiology
15884921|NCT03766815|Dietary Supplement|BCAA 200mg/kg/day|BCAA supplement based on 200mg/kg/day for 18 days.
15884922|NCT03766815|Dietary Supplement|Placebo|Fiber supplement jelly for 18 days.
15884923|NCT03766815|Dietary Supplement|BCAA 400mg/kg/day|BCAA supplement based on 400mg/kg/day for 18 days.
15884924|NCT03766815|Behavioral|Muscle damaging exercise|Participants will be asked to perform muscle damaging elbow eccentric contraction exercise at 120% of 1RM for three sets of 15 repetitions with the dominant arm at maximal effort on a Biodex machine with a 3 minute rest period between each set.
15884925|NCT03766802|Behavioral|Wearable watch training group.|3 orientation session Watch notifies 3/week for exercise
15884926|NCT03766802|Behavioral|Mobile application training group.|"3 orientation session App notifies 3/week for exercise
~Benefits of app:
~Cheaper Trackable and notifiable if patients don't exercise."
15884927|NCT03766802|Behavioral|Supervised exercise training group|3/week training supervised by a physical therapist
15884928|NCT03766789|Device|Cell phone application|cell phone to organize medications
15884929|NCT03766776|Drug|Anlotinib|Anlotinib capsules: dosage of 12 mg PO qd, 14 days, 7 days, 21 days for a cycle. The dosage was adjusted according to the adverse reactions of patients.
15884930|NCT03766763|Drug|Venetoclax|"Venetoclax is administered according to the usual schedule an escalating dose from 20 milligram per day the first week, then 50 milligram per day the second week, 100 milligram per day the third week, 200 milligram per day the fourth week and then 400 milligram per day.
~For patient achieving a Compete Response with Minimal Residual Disease inferior to 0,01 percent in bone marrow at month 12, treatment will be stopped at month18 (18 months for total duration of treatment ).
~For responding patients at month12 (Complete Response or Partial Response) with bone marrow Minimal Residual Disease inferior to 0.01 percent, treatment will be continued until month 24 (24 months for total duration of treatment)."
15884931|NCT03766750|Drug|LIMA association|1 coated tablet, oral, once a day.
15884932|NCT03766750|Drug|Tradjenta|1 coated tablet, oral, once a day.
15884933|NCT03766750|Drug|Forxiga|1 coated tablet, oral, once a day.
15884934|NCT03766737|Device|An intelligent visual acuity diagnostic system for children|An artificial intelligence to make evaluation and of children's vision.
15884935|NCT03766724|Drug|Evogliptin→Evogliptin+Empagliflozin→Empagliflozin|Evogliptin : Evogliptin 5mg QD, Evogliptin+Empagliflozin : Evogliptin 5mg QD + Empagliflozin 25mg QD, Empagliflozin : Empagliflozin 25mg QD
15884936|NCT03766724|Drug|Empagliflozin→Evogliptin→Evogliptin+Empagliflozin|Empagliflozin : Empagliflozin 25mg QD, Evogliptin : Evogliptin 5mg QD, Evogliptin+Empagliflozin : Evogliptin 5mg QD + Empagliflozin 25mg QD
15884937|NCT03766724|Drug|Evogliptin→Evogliptin+Dapagliflozin→Dapagliflozin|Evogliptin : Evogliptin 5mg QD, Evogliptin+Dapagliflozin : Evogliptin 5mg QD + Dapagliflozin 10mg QD, Dapagliflozin : Dapagliflozin 10mg QD
15884938|NCT03766724|Drug|Dapagliflozin→Evogliptin→Evogliptin+Dapagliflozin|Dapagliflozin : Dapagliflozin 10mg QD, Evogliptin : Evogliptin 5mg QD, Evogliptin+Dapagliflozin : Evogliptin 5mg QD + Dapagliflozin 10mg QD
15884939|NCT03766711|Other|Physical Therapy|Repetitive bimanual task training for upper limb motor function recovery.
15884940|NCT03766685|Drug|Bimekizumab|Subjects will receive bimekizumab at pre-specified time-points.
15884941|NCT03766672|Diagnostic Test|Intervention Arm|The intervention consists to the characterization of molecular mechanisms using to Next Generation Sequencing (NGS) technique.
15884942|NCT03766659|Diagnostic Test|MOSE|EUS-FNB with MOSE
15884943|NCT03766659|Diagnostic Test|ROSE|EUS-FNA with ROSE
15884944|NCT03766646|Device|Optiflow|45l.min oxygen
15884945|NCT03766633|Diagnostic Test|Liver volumetry of the graft on CT|Preoperative liver volumetry using the CT images of the potential living liver donors.
15884946|NCT03766607|Drug|Trastuzumab|Trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) administered intravenously every 21 days
15884947|NCT03766607|Drug|Ramucirumab|Ramucirumab 8 mg/kg administered intravenously on days 1 and 15 every 28 days
15884948|NCT03766607|Drug|Paclitaxel|Paclitaxel 80 mg/m2 administered intravenously on days 1, 8, and 15 every 28 days
15884949|NCT03766594|Drug|Sildenafil Citrate|Respatio(R) 25mg tablets four times daily for 24 days preconceptionally starting first day of previous period
15884950|NCT03766594|Drug|Folic Acid|Folic acid(R) 0.5mg tablets once daily for 3 months preconceptionally
15884951|NCT03766594|Drug|Placebo Oral Tablet|Placebo tablet apparently identical to Respatio(R) 25mg tablets, taken four times daily for 24 days preconceptionally starting first day of previous period
15884952|NCT03766581|Drug|BMS-986177|Oral administration
15884953|NCT03766581|Other|Placebo|Oral Administration
15884954|NCT03766581|Drug|Clopidogrel|Oral administration
15884955|NCT03766581|Drug|Aspirin|Oral administration
15884956|NCT03766568|Device|JGG endoscope(R)|The JGG endoscope(R) is attached to the new generation of Heine® otoscopes with a LED light source that allows the inspection of the ostium in the middle meatus and collection of material for bacterial culture for the diagnosis of ABRS in primary care. After local anaesthesiology of the cavum nasi a sample material for cultures can be gained (earliest 10 min after local anaesthesia). The diagnostic procedure poses patients at minimal risk for complications and is of very little and short-termed discomfort.
15884957|NCT03766555|Procedure|Microwave ablation|Microwave ablation will be performed in operation theatre under general anesthesia via laparoscopic or open approach according to the tumors' locations. In case of open approach, it will be done via a right subcostal incision with possible upper midline extension was necessary. After diagnostic laparoscopy in laparoscopic approach and exploratory laparotomy in open approach to exclude the presence of extra-hepatic disease, operative ultrasound (Aloka, Tokyo, Japan) will be performed to exclude preoperatively undetected lesion; guide insertion of the microwave applicator; and monitor the whole ablation process. Surrounding organs were cooled by constant irrigation of ice-cold saline to prevent thermal injury. The ablation will be carried out according to the standard protocol with the aim to create a 1cm ablation margin around the tumor. The insertion track will be burnt after ablation in order to prevent bleeding and tumor seeding.
15885044|NCT03765788|Biological|Secukinumab 300 mg, s.c.|Secukinumab will be administered at a dose of 300 mg as s.c. injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to Week 48.
15884958|NCT03766555|Procedure|Liver resection|Liver resection will be performed as described previously. Liver parenchymal transection would be performed with CUSA (cavitron ultrasonic surgical aspirator) and TissueLink (a radiofrequency saline-linked dissecting sealer) in both arms. Vascular staplers would be used to divide major vascular pedicles. Fibrin glue (Tisseel) spray would be applied to the parenchymal cut surface of the liver before closure of abdomen.
15884959|NCT03766542|Device|Bi-level positive airway pressure with ventilatory support|Positive airway pressure will be applied in the experimental group through a oronasal interface, in ventilatory support mode (Bi-level) with a fixed backup rate.
15884960|NCT03766542|Device|continuous positive airway pressure without ventilatory support|Continuous positive airway pressure (CPAP) will be applied in the active comparator group through a oronasal interface.
15884961|NCT03766529|Procedure|loop isolation-based uploading preconditioning (LiuPhD)|declamping was not done until heart could resume normal mechanical activities and sustain well for three minutes in terms of heart rate, rhythm, and myocardial contractility via continuous antegrade warm blood delivery closely following TWBC reperfusion.
15884962|NCT03766503|Other|Daily|The main study intervention is the daily witnessing of participants while they self-administer their medications by trained pharmacy staff to ensure compliance. The staff in question will be provided by Leila pharmacy and will in addition provide support so that individuals can transition back into living independently through reminders to attend regularly scheduled medical appointments and counseling on correct use of prescribed medications.
15884963|NCT03766490|Drug|Anlotinib Hydrochloride|Capsule, P.O. 12mg qd ,days 1-14, 21 days a cycle
15884964|NCT03766490|Drug|Gefitinib|Tablet, P.O. 250mg qd
15884965|NCT03766490|Drug|Icotinib|Tablet, P.O. 125mg tid
15884966|NCT03766477|Diagnostic Test|Pittsburgh Sleep Quality Index (IQSP) and Johansson|All participants will to answer the Pittsburgh Sleep Quality Index (IQSP) and Johansson questionnaires before polysomnography examination and use of APP.
15884967|NCT03766477|Diagnostic Test|Smartphone APP|All study participants will use a smartphone application (APP), which will be made available by the researchers, at the same time as the polysomnography exam.
15884968|NCT03766477|Diagnostic Test|Polysomnography|All participants slept for one night in a sleep laboratory for PSG recording. The data will be confirmed by an otorhinolaryngology certified by the Brazilian Association of Sleep Disorders
15884969|NCT03766464|Diagnostic Test|Evaluation of TMD and pain sensitivity|Extra and intraoral clinical examination will be performed and the Diagnostic Criteria for Temporomandibular Disorders (DC / TMD) questionnaire will be applied. Measurements shall be bilateral in the masseter, anterior temporal and tenar muscles and the arithmetic mean between three measurements will be considered the value for each side for pain sensitivity analysis with an dynamometer.
15884970|NCT03766464|Diagnostic Test|Evaluation of SB|The presence or absence of SB will be diagnosed by Polysomnography
15884971|NCT03766464|Diagnostic Test|Evaluation of AB|A smartphone will be used, which was developed for a momentary evaluation that allows a report of the exact moment of AB and its possible associated symptoms.
15884972|NCT03766438|Behavioral|Digital Storytelling Intervention|12-minute digital storytelling intervention in Spanish, with four individuals explaining their personal Type 2 Diabetes stories.
15884973|NCT03766425|Drug|Aflibercept|subconjunctival injection
15884974|NCT03766425|Drug|Mitomycin|subconjunctival injection
15884975|NCT03766412|Other|High School start time|The time that the school starts
15884976|NCT03766399|Drug|AZD0449|Participants will receive single inhaled AZD0449 nebulizer suspension and single IV dose of AZD0449 solution.
15884977|NCT03766399|Drug|Placebo|Participants will receive single dose of placebo for AZD0449 (nebulizer suspension).
15884978|NCT03766373|Combination Product|Drug: OP0201 20mg|OP0201
15884979|NCT03766373|Combination Product|Drug: Placebo 0mg|Placebo
15884980|NCT03766360|Behavioral|Functional Analytical Psychotherapy (FAP)|The intervention itself is based on the procedures of Functional Analytic Psychotherapy, a behavioral intervention focusing on improving social functioning.
15884981|NCT03766334|Dietary Supplement|Highland Barley Diet|Highland Barley Diet(20g, thrice-daily)
15884982|NCT03766321|Biological|Fecal microbiota transplantation|Fecal microbiota transplantation will be performed during two endoscopic procedures (baseline and at 6 months) by allogenic infusion of collected feces in the duodenum-jejunum.
15884983|NCT03766321|Biological|Placebo|patients will undergo endoscopic procedure with biopsy during sedation but without any kind of intervention
15884984|NCT03766308|Dietary Supplement|Highland Barley Diet|Highland Barley Diet
15884985|NCT03766308|Dietary Supplement|ADA diet|ADA diet
15884986|NCT03766295|Drug|Masitinib|
15884987|NCT03766295|Drug|Gemcitabine|
15884988|NCT03766295|Drug|Placebo|
15884989|NCT03766282|Device|ECMO|Extracorporeal membrane oxygenation (ECMO) temporarily supports patients with severe cardio-respiratory failure
15884990|NCT03766269|Drug|Dronabinol|Dronabinol coadministered with patient's existing Baseline Opioid.
15884991|NCT03766256|Behavioral|Shared decision-making with pharmacists|Pharmacist will engage patient with history of gestational diabetes mellitus using Healthwise (TM) Decision Tool to help match their personal preferences and values with treatment options, specifically lifestyle change will be referred to a CDC (Center for Disease Control and Prevention) approved diabetes prevention program, and pharmacists will coordinate with primary care providers to prescribe metformin for patients interested in this treatment.
15884992|NCT03766243|Behavioral|Brochure and DVD plus nursing training|"After recruitment for both groups of participants, in a 30-minute meeting, a clinical nurse measured the opening of the mouth. She gave each participant the information brochure, the audio-visual DVD for self-management of oral exercises, diary card, and the research questionnaires, and explained their content and use.
~The intervention consisted of stretching exercises and movements involving the mimic muscles to perform in front of a mirror. The control group could learn the standardized exercises for the mouth-opening through information brochure and the audio-visual DVD.
~The experimental group was closely followed by the research nurse, an expert in Adult Education, who held 20-minute face to face meetings at baseline and at follow-up with the patients allocated to the experimental group. For both groups an information brochure and an audio-visual DVD were developed specifically for the study. The audio-visual DVD is available on the IDI-IRCCS institutional website."
15897054|NCT03673111|Drug|Y14|Gut hormone analogue
15884993|NCT03766243|Behavioral|Brochure and DVD only|"After recruitment for both groups of participants, in a 30-minute meeting, a clinical nurse measured the opening of the mouth. She gave each participant the information brochure, the audio-visual DVD for self-management of oral exercises, diary card, and the research questionnaires, and explained their content and use.
~The intervention consisted of stretching exercises and movements involving the mimic muscles to perform in front of a mirror. The control group could learn the standardized exercises for the mouth-opening through information brochure and the audio-visual DVD."
15884994|NCT03766217|Combination Product|Mesenchymal stem cells associated with biomaterials|Deciduous dental pulp mesenchymal stem cells associated with hydroxyapatita/collagen.
15884995|NCT03766217|Combination Product|Iliac crest autogenous bone graft|Autogenous bone will be obtained from iliac crest.
15884996|NCT03766191|Behavioral|Food Ads|Exposure to foods ads that are embedded in an age-appropriate TV program
15884997|NCT03766191|Other|Non-food Ads|Exposure to non-food ads that are embedded in an age-appropriate TV program
15884998|NCT03766178|Drug|Nimotuzumab + SHR-1210|"SHR-1210: 200 mg/time, intravenous injection, q2W continuous medication, a course of treatment needs 28 days. The cumulative longest medication period is 2 years.
~Nimotuzumab: 200 mg/time, intravenous injection, administered on the 1st and 8th days of each cycle, every 2 weeks is one cycle."
15884999|NCT03766165|Behavioral|Intervention|Participants will receive job announcements plus educational sessions, mentoring, behavioral economic text messages, and a start-up grant.
15885000|NCT03766165|Behavioral|Control|Participants will receive job announcements only.
15885001|NCT03766152|Device|Adhesive bone conduction hearing aid (ADHEAR - Med El)|Patients are asked to wear an adhesive bone conduction hearing device which is attached to the mastoid with an adhesive adapter
15885002|NCT03766139|Biological|SUPERCELL GLUE|Following optimum anaesthesia, reflection of full thickness mucoperiosteal flaps for defect access and thorough debridement will be done. Subsequently the defect will be filled with supercell glue in test sites (randomly selected by computer generated tabulation method)
15885003|NCT03766139|Biological|PRFM ALONE|Following optimum anaesthesia, reflection of full thickness mucoperiosteal flaps for defect access and thorough debridement will be done. Subsequently the defect will be filled with PRFM in control sites(randomly selected by computer generated tabulation method)
15885004|NCT03766126|Biological|CART123 cells; cyclophosphamide; fludarabine|"CART123 cells following lymphodepleting chemotherapy in patients with relapsed/refractory AML. Subjects will be treated with a split dosing approach of CART123 cells (10% Day 0; 30% Day 1; 60% Day 2) for Cohort 1a/1b or a single IV administration of CART123 cells for Cohort 2.
~The total dose administered to each subject will be based on body weight obtained at the time of apheresis. Thus, the target total transduced dose, preceded by lymphodepleting chemotherapy, is 1-2x10^6 CART123 cells/kg for Cohort 1a, 5x10^6 CART123 cells/kg for Cohort 1b, or 2x10^6 CART-123 cells/kg for Cohort 2. The protocol-specified minimum acceptable dose for infusion is 1x10^5 CART123 cells/kg."
15885005|NCT03766113|Other|Neurofeedback coupling electroencephalogram and functional MRI in time actual|One visit : Neurofeedback coupling electroencephalogram and functional MRI in time actual
15885006|NCT03766113|Other|Electroencephalogram-neurofeedback program or Neurofeedback-free mental imaging program with electroencephalogram recording|"Interventional group (Electroencephalogram-neurofeedback program) : 24 minutes, 3 times a week for 12 weeks in addition to the traditional rehabilitation program.
~Controle Group (Neurofeedback-free mental imaging) : 24 minutes, 3 times a week for 12 weeks in addition to the traditional rehabilitation program of reference."
15885007|NCT03766113|Other|Neurofeedback coupling electroencephalogram and functional MRI in time actual or a neurofeedback-free mental imaging program with electroencephalogram recording|"Interventional group (5 weeks) : 5 sessions of neurofeedback coupling electroencephalogram and functional MRI in time actual and 9 sessions of electroencephalogram-neurofeedback program
~Controle Group (5 weeks) : 14 sessions of neurofeedback-free mental imaging program"
15885008|NCT03766100|Behavioral|Cognitive behavioural therapy (CBT-i)|CBT-i aims to alter behaviours that sustain or add to insomnia and correct cognitions that drive these behaviours. The behavioural components of CBT-i are stimulus control (SC) and Sleep Restriction Therapy (SRT). SC works through the extinction of a conditioned arousal that emerges when bed and bedroom have become associated with wakefulness. With SRT time in bed is reduced to build up sleep pressure. When wakefulness is decreased, time in bed is gradually increased until optimal sleep is attained. With the cognitive component, insomnia is treated by identifying and changing unhelpful or inaccurate thinking regarding sleep and distressing emotional responses to insomnia. The last component of CBT-i aims to reduce hyperarousal with relaxation techniques, scheduled worry time, creating a time to unwind, and employing cognitive therapy strategies.
15885009|NCT03766087|Procedure|decompressive craniectomy|decompressive craniectomy is decompression at the supratentorial level that is achieved by removing part of the skull and by making an opening, in the dura mater (with or without plastic surgery), without compromising the venous sinus.
15885010|NCT03766074|Dietary Supplement|vitamin D supplement|The intervention group receives 50000 IU of vitamin D every 2 weeks as vitamin D supplements for 8 weeks, provided monthly.
15885011|NCT03766074|Dietary Supplement|Placebo|placebo
15885012|NCT03766061|Procedure|Onlay mesh Hernioplasty|Patients with paraumblical hernia are treated with onlay mesh hernioplasty in which mesh is placed on anterior rectus sheath
15885013|NCT03766061|Procedure|Sublay Mesh Hernioplasty|Patients with paraumblical hernia are treated with sublay mesh hernioplasty in which mesh is placed in retromuscular space
15885014|NCT03766048|Procedure|Single-Anterior-Mesh, SAM|laparoscopic sacropexy is only performed with the anterior mes
15885015|NCT03766048|Procedure|Double-Mesh, DM|laparoscopic sacropexy is performed using two synthetic non-absorbable meshes, both sutured to the promontory (Double-Mesh, DM): one mesh is placed in the vesicovaginal space and sutured to the uterine cervix or vaginal apex, and one mesh is placed in the rectovaginal space
15885016|NCT03766035|Device|SpyGlass DS I - II|The SpyScope™ DS Access and Delivery Catheter (SpyScope™ DS Catheter) is a sterile, single-use endoscope that enables access and delivery of accessories to targeted pancreaticobiliary anatomy and displays live video when connected to a Spy Glass DS Digital Controller.
15885017|NCT03766022|Device|Neo dental implant Alpha Bio Tec. Ltd.|Neo dental implant is used to restore missing teeth
15885018|NCT03766009|Other|Usual Care|Usual Care
15885019|NCT03766009|Other|Web-based decision aid|Web-based decision aid received prior to the surgical consultation
15885020|NCT03765996|Other|Decongestive Physiotherapy|This group received CDP, which include MLD, short-stretch bandages, lymph-reducing exercises, and skin care. MLD was applied to the anterior trunk, posterior trunk, and the base of the neck, progressing to the affected limb. Short-stretch bandages were applied in multiple layers after MLD. A low pH skin lotion was applied prior to bandaging and then stockinette was placed on the arm. The fingers and the hand were wrapped in gauze. A layer of cotton was wrapped around the arm. Bandages (6, 8 and/or 10cm) were sequentially applied in a spiral fashion around the limb with the smallest bandage starting at the hand. The most compression was at the most distal points and gradually decreased proximally. Exercises were done by patients to improve mobility and enhance lymphatic flow.
15885021|NCT03765996|Other|Decongestive Physiotherapy plus taping|This group received CDP as same protocol of active comparator. In addition, Kinesiotaping was applied to anterior and posterior axillo-axillary anastomosis and axillo-inguinal anastomosis. The tape was started on the unaffected side and strips of tape were applied so as to reach the affected side regarding anterior and posterior axillo-axillary anastomosis. For axillo-inguinal anastomosis, the tape was started in the inguinal region of the affected side and strips of tape were applied so that they reached the axillary region.
15885022|NCT03765983|Drug|Trastuzumab|"Trastuzumab is called a targeted therapy because it works by attaching itself to specific receptors on the surface of breast cancer cells, known as HER2 receptors. When targeted therapies attach to HER2 receptors, the signals that tell the cells to grow are blocked and the cancer cell may be marked for destruction by the immune system"
15885023|NCT03765983|Drug|GDC-0084|GDC-0084 has been shown to stop the activity of a protein called PI3-kinase. This action blocks a pathway in the body that cancer cells commonly use to grow and divide
15885024|NCT03765957|Biological|Mesenchymal Stem Cells|After the subjects are screened and qualified, random number envelopes will be selected to group 12 subjects into group A, group B, group C and group D at a ratio of 1:1:1:1. The subjetcts of group A and B will be injected intravenously with 1.5x10E6/kg and 2.0x10E6/kg（according to the weight of subject）mesenchymal stem cells respectively at baseline and every 2 weeks, 4 times is a course of treatment. Subjects will be followed up for evaluation on 15 days, 30 days, 45 days, month 2, month 3 and month 6 after treatment. The subjetcts of group C and D will be injected intravenously with 2.5x10E6/kg and 3.0x10E6/kg （according to the weight of subject）mesenchymal stem cells respectively at baseline and every 4 weeks, 2 times is a course of treatment. Subjects will be followed up for evaluation on 15 days, 30 days, 45 days, month 2, month 3 and month 6 after treatment. Besides MSCs, moisturizers such as boric acid ointment will be given to all subjects.
15885025|NCT03765944|Drug|sirolimus|SIngle administration under fasted condition
15885026|NCT03765931|Drug|Doxycycline|The investigators conducted a non-inferiority, open-label, randomized controlled trial in patients aged > 8 years recruited from dispensaries in the rural area of Niakhar, Senegal. Participants were enrolled based on a body temperature > 37.5°C, as assessed using an electronic axillary thermometer. Febrile patients with a positive malaria test were excluded from the study. Participants were randomly assigned (2:1) to receive either a single dose of doxycycline (30 mg/kg) or a five-day course of amoxicillin (20 mg/kg) by a computer-generated random number sequence. The investigators monitored participants at days 2 and 7 post-treatment. The primary outcome was cure after 7 days, defined as a body temperature < 37.5°C.
15885027|NCT03765931|Drug|Amoxicillin|The investigators conducted a non-inferiority, open-label, randomized controlled trial in patients aged > 8 years recruited from dispensaries in the rural area of Niakhar, Senegal. Participants were enrolled based on a body temperature > 37.5°C, as assessed using an electronic axillary thermometer. Febrile patients with a positive malaria test were excluded from the study. Participants were randomly assigned (2:1) to receive either a single dose of doxycycline (30 mg/kg) or a five-day course of amoxicillin (20 mg/kg) by a computer-generated random number sequence. The investigators monitored participants at days 2 and 7 post-treatment. The primary outcome was cure after 7 days, defined as a body temperature < 37.5°C.
15885033|NCT03765905|Diagnostic Test|study|Scube-1 scube-2 scube-3
15885034|NCT03765892|Other|Questionnaire (Adult)|"Patients and case control will have to respond to the study questionnaire on the online entry platform to compare the distribution of socio-professional categories.
~Answering the questionnaires will take 45 minutes."
15885035|NCT03765892|Other|Questionnaire (Children)|"Patients and case control will have to respond to the study questionnaire on the online entry platform to compare the proportion of subjects having repeated grades.
~Answering the questionnaires will take 45 minutes."
15885036|NCT03765879|Other|Verum VGAIT (Video-Guided Acupuncture Imagery Treatment)|In VGAIT treatment sessions, participants will re-watch the video of themselves receiving acupuncture treatment, and they will be asked to vividly imagine that the treatment is being concurrently applied.
15885037|NCT03765879|Other|Sham VGAIT (Video-Guided Acupuncture Imagery Treatment)|In sham VGAIT treatment sessions, participants will re-watch this video of themselves receiving the sham acupuncture treatment, and they will be asked to vividly imagine that the treatment is being concurrently applied.
15885038|NCT03765866|Procedure|Thromboelastometry guided transfusion|Comparing resuscitation strategies with standard MTP v.s. ROTEM guided MTP
15885039|NCT03765853|Other|Physiotherapy|Usual prevention methods (ergonomic education) and Stretching Postural® postures.
15885040|NCT03765827|Drug|Vitamine E Acetate|Vitamin E acetate ointment will be applied over the staple lines and anastomoses in Roux-en-Y gastric bypass
15885041|NCT03765827|Drug|No application of vitamin E acetate|Vitamin E acetate ointment will not be applied in this group
15885042|NCT03765801|Drug|GRTA9906 60 mg PR tablet|GRTA9906 60 mg PR tablet
15885043|NCT03765801|Drug|GRTA9906 60 mg IR capsule|GRTA9906 60 mg IR capsule
15886541|NCT03754218|Procedure|SOC Wound Covering|Institutional standard of care wound covering.
15885045|NCT03765788|Drug|Prednisolone|Prednisolone will be administered at tapering oral doses as tablets daily for 26 weeks according to the protocol-defined schedule. Prednisolone will also be administered as escape therapy to treat disease flares in an open-label manner at a dose and duration selected by the investigator.
15885046|NCT03765788|Drug|Placebo to match Secukinumab, s.c.|Placebo will be administered as s.c. injection at Baseline, Week 1,2,3,4 and then every 4 weeks thereafter through to Week 48.
15885047|NCT03765775|Biological|Sintilimab|Participants receive Sintilimab(IBI 308) 200 mg, administered as intravenous (IV) infusion on Day 1 of each 21-day cycle
15885048|NCT03765775|Drug|Anlotinib Hydrochloride|Participants receive Anlotinib 10 mg, administered as PO on Day 1-14 of each 21-day cycle
15885049|NCT03765762|Drug|GRF6019|GRF6019 for IV infusion
15885050|NCT03765762|Other|Placebo|Placebo for IV infusion
15885052|NCT03765710|Other|Recommended protein intake|Recommended protein intake in a mixed meal contained 13% protein, 54% carbohydrate, and 33% fat.
15885053|NCT03765710|Other|Elevated protein intake|Increased protein intake in a mixed meal contained 26% protein, 44% carbohydrate, and 30% fat.
15885054|NCT03765697|Drug|Lidocaine 5% medicated plaster|Topical application at the site of skin affected by painful PHN for up to 12 hours per day (plaster-free interval at least 12 hours).
15885055|NCT03765671|Drug|Elafibranor|120mg oral single dose
15885056|NCT03765658|Drug|GRT0151Y dose escalation|Single doses of 150, 200, 250, 300, 350 and 400 mg (3, 4, 5, 6, 7 or 8 capsules of 50 mg)
15885057|NCT03765658|Drug|Matching placebo|Matching placebo capsules (3, 4, 5, 6, 7 or 8 capsules)
15885058|NCT03765645|Drug|Piperacillin + Tazobactam|Antibiotic used will be Piperacillin + Tazobactam Dose: 4.5 g, thrice a day at regular intervals Route: Intra-venous
15885059|NCT03765632|Genetic|Infusion of autologous cryopreserved EFS-ADA LV CD34+ cells (OTL-101)|Autologous cryopreserved EFS-ADA LV CD34+ cells (OTL-101) are infused intravenously
15885060|NCT03765632|Drug|Busulfan|Busulfan is used for non-myeloablative conditioning
15885061|NCT03765632|Drug|Peg-Ada|Peg-Ada Enzyme Replacement Therapy (ERT) is discontinued at Day +30 (-3/+15 days) after successful engraftment
15885062|NCT03765619|Drug|Aspirin|250 patients will be randomized to receive postoperative Aspirin.
15885063|NCT03765606|Dietary Supplement|Cocoa Flavanol beverage mix|Acute consumption of single portion of cocoa powder dissolved in 310g 1% milk.
15885064|NCT03765606|Dietary Supplement|De-xanthinated Cocoa Flavanol beverage mix|Acute consumption of single portion of cocoa powder dissolved in 310g 1% milk.
15885065|NCT03765593|Procedure|Biopsy Salivary Gland|A minor salivary gland biopsy will be performed at lower lip, with the minimally invasive technique that is carried out in Rheumatology Unit as a routine procedure for the diagnosis of pSS, from there it will be taken between 2-3 glands for the study. RNAlater®(Ambion, Inc., Texas, United States of America) will be stored in solution for the stabilization and preservation of RNA at -80ºC.
15885066|NCT03765580|Dietary Supplement|Fish|Lunch containing fish
15885067|NCT03765580|Other|Control|Lunch containing no fish
15885068|NCT03765567|Drug|Vancomycin|2 vials of Vancomycin 1g powder will be applied topically to the open fracture wound site.
15885069|NCT03765554|Drug|PF-06700841 Immediate release tablets|Small molecule tablets in immediate release form
15885070|NCT03765554|Drug|PF-06700841 Modified release tablets|Small molecule tablets in modified release form
15885071|NCT03765541|Drug|Dexamethasone|"In combination with intensive chemotherapy amsacrine-cytarabine:
~Induction (1 cycle): 10 mg/12h from Day 1 to Day 3 of cycle (2 infusions/24h, slow IV [10 minutes])
~Consolidation (3 cycles): 10 mg/12h from Day 1 to Day 3 of each cycle (2 infusions/24h, slow IV [10 minutes])
~In combination with azacitidine:
~Cycle 1: 20 mg/24h from Day 1 to Day 3 of cycle (1 infusion/24h, slow IV [10 minutes]).
~Subsequent cycles: 20 mg/24h on Day 1 of each cycle (1 infusion/24h, slow IV [10minutes])."
15885072|NCT03765541|Drug|Amsacrine|"Induction (1 cycle): 200 mg/m2/24h from Day 1 to Day 3 of cycle (slow IV [3 hours])
~Consolidation (3 cycles): 200 mg/m2/24h on Day 1 of each cycle (slow IV [3 hours])"
15885073|NCT03765541|Drug|Cytarabine|"Patients < 60 years of age:
~Induction (1 cycle): 3 g/m2/12h from Day 1 to Day 4 of cycle (2 infusions/24h, slow IV [2 hours])
~Consolidation (3 cycles): 3 g/m2/12h from Day 1 to Day 3 of each cycle (2 infusions/24h, slow IV [2 hours]) Note: If the investigators believe that there is an undue risk for the safety of a patient under 60 years of age with comorbidity in receiving a dose level of 3 g/m2/12h, the dose may be reduced to 1 g/m2/12h"
15885074|NCT03765541|Drug|Azacitidine|75 mg/m2/24h from Day 1 to Day 7 of each cycle [or from Day 1 to Day 5 and from Day 8 to Day 9 of each cycle] (SC)
15885075|NCT03765515|Device|Twinfix Ti|The purpose is to evaluate the safety and efficacy of Q-Fix in patients requiring the repair of soft tissue of shoulder who receive the arthroscopic repair of soft tissue using Q-Fix, when compared with the patients receiving the treatment with Twinfix Ti Suture Anchor. The result of this trial will be used for the Q-Fix All-suture Anchor registration in China.
15885076|NCT03765515|Device|Q-Fix|Q-Fix
15885077|NCT03765502|Device|Nasal Glucagon Device (NG)|NG devices will be provided empty of drug product
15885078|NCT03765502|Device|GEK|Used to administer glucagon intramuscularly (IM)
15885079|NCT03765502|Drug|IM Glucagon|Administered IM via GEK
15885080|NCT03765489|Device|electrical muscle stimulation|electrical muscle stimulation: The parameters used in biceps were: 35 Hz, 250 μs and in quadriceps were: 50 Hz, 400 μs. In both, biphasic wave was used, 45 minutes of total work, 5 seconds of contraction and 10 seconds of relaxation and the intensity was adjusted to present a visible contraction
15885081|NCT03765489|Procedure|conventional physical therapy|"conventional physical therapy according to the adaptation of the Start to move protocol of Gosselink et al"
15885082|NCT03765476|Behavioral|SALIENCE|"3 computer-based training sessions with program SALIENCE per week over 3 weeks (see study description)"
15885083|NCT03765476|Behavioral|TAU|treatment as usual, , i.e. medically supervised detoxification treatment (i.e. medical management of withdrawal symptoms, associated physical discomfort and any co-existing disorders, etc.) as well as health education and supportive therapy sessions.
15885084|NCT03765463|Behavioral|Habit Reversal Training|4 sessions of habit reversal training
15885085|NCT03765450|Drug|Infliximab|Patients will receive infliximab at the discretion of their physician as part of standard of care.
15885086|NCT03765437|Biological|Quadrivalent Influenza Vaccine|Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
15885087|NCT03765424|Diagnostic Test|Ultrasound|Ultraosund of temporal, carotid and axillary arteries
15885088|NCT03765411|Procedure|Proctectomy|Resection of the rectum
15885089|NCT03765398|Behavioral|VR Cognitive-motor-balance training|The participant will play four of the six balance board games Table tilt, Tightrope, Soccer, Balance bubble, Light Run and Basic Step (each game is max 1.5 minutes). Each game will be superimposed with any 3 of the 6 cognitive tasks (word list generation consisting of verbal fluency (VF) and category fluency (CF), digit recall (DR), analogies (AN), mental arithmetic (MA), repeated letter (RL). The cognitive tasks will be randomized making sure that all the cognitive tasks are played with all the games. The cognitive and balance board game scores will be noted on the scoring sheet for each session. A total 10 minutes rest interval between every sub-session will be mandatorily provided.
15885090|NCT03765385|Other|High-intensity training|Sessions will be performed twice weekly for 12 weeks, in groups of 8-10 participants and two supervisors.
15885091|NCT03765385|Other|Moderate-intensity continuous training|Sessions will be performed twice weekly for 12 weeks, in groups of 8-10 participants and two supervisors.
15885092|NCT03765359|Drug|metforminhydrochloride|metformin 500 mg tablets and insulin
15885093|NCT03765359|Drug|Placebo Oral Tablet|Placebo tablets mimic metformin 500 mg tablets and insulin
15885094|NCT03765346|Drug|Oxycodone IR ADF|Oxycodone IR ADF manipulated/crushed (mass of 540 mg, containing oxycodone hydrochloride 30 mg), in a standardized procedure.
15885095|NCT03765346|Drug|Oxycodone API powder|Oxycodone API powder (mass of 30 mg), containing oxycodone hydrochloride 30 mg.
15885096|NCT03765346|Drug|Placebo to match oxycodone API powder|Placebo to match oxycodone API powder (mass of 30 mg).
15885097|NCT03765346|Drug|Placebo to match manipulated oxycodone IR ADF.|Placebo to match oxycodone IR ADF, manipulated (mass of 540 mg).
15885098|NCT03765320|Procedure|Peritoneal closure|Peritoneal closure after pelvic lymph node dissection for early gynecologic cancer
15885099|NCT03765320|Procedure|Retroperitoneal drainage|Retroperitoneal drainage after pelvic lymph node dissection for early gynecologic cancer
15885100|NCT03765307|Device|SyMap Bronchial Ablation System|The Bronchial Ablation is performed using SyMap Bronchial Ablation System in three sessions at least three weeks apart between each session: Right Lung Lobe, Left Lung Lobe, Right Up Lobe and Left Up Lobe.
15885101|NCT03765307|Device|Boston Scientific Alair System|The Bronchial Thermoplasty is performed using Boston Scientific Alair System in three sessions at least three weeks apart between each session: Right Lung Lobe, Left Lung Lobe, Right Up Lobe and Left Up Lobe.
15885102|NCT03765294|Drug|ACT-541468|Film-coated tablet for oral use
15885103|NCT03765294|Drug|Placebo|Film-coated tablet for oral use
15885104|NCT03765281|Other|Navigation|Service delivered by clinical Navigator who learns about youth and family's needs and matches to appropriate services.
15885105|NCT03765281|Other|Resource List|Extensive list of mental health and addictions resources, information, and services. Contact information and web links provided for individuals to explore and contact resources of interest.
15885106|NCT03765268|Procedure|Neurectomy in inguinal hernia repair|Mesh hernioplasty of inguinal hernia with neurectomy of ilioinguinal and iliohypogastric nerve
15885107|NCT03765268|Procedure|nerve sparing in inguinal hernia repair|Mesh hernioplasty of inguinal hernia with sparing of ilioinguinal and iliohypogastric nerve
15885108|NCT03765255|Other|In the Know: sexual health education|The in-person sessions include modules on: sexual and reproductive health (2 hours - anatomy, gender and sexual orientation, pregnancy, contraception, sexually transmitted infections); healthy relationships and life skills (2 hours - communication and negotiation, consent, violence, online dating, goal setting, strengths); and educational and career success (2 hours - educational and career options, applying for scholarships and financial aid, job readiness, resume preparation, interview skills). The app includes: online referrals, personal life plans/goal setting, text message reminders, quizzes, and other resources.
15885109|NCT03765242|Other|Non-Interventional|Non-Interventional
15885110|NCT03765229|Drug|Entinostat|Oral drug 5 mg taken once weekly for up to nine 3-week (21 day) cycles. Take on an empty stomach i.e., at least 2 hours after a meal and at least 1 hour before the next meal. On days when entinostat is administered on the same day as pembrolizumab, entinostat should be taken before the pembrolizumab infusion.
15885111|NCT03765229|Drug|Pembrolizumab|200 mg IV starting on Day 22 (cycle 2, Day 1) given every 3 weeks for up to 8 cycles.
15885112|NCT03765216|Drug|2L Polyethylene Glycol (PEG)|Participants in Group A and Low risk patients in group B are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen
15885113|NCT03765216|Drug|4L Polyethylene Glycol (PEG)|High risk patients in Group B will receive 4 L Polyethylene Glycol (PEG) regimen
15885114|NCT03765203|Diagnostic Test|Natera KidneyScan|Online educational materials on Natera Kidneyscan (dd-cfDNA) and sample test results for simulated patients
15885115|NCT03765203|Other|Clinical Performance and Value Vignettes|Online renal allograft simulated patients
15885116|NCT03765190|Combination Product|Radiation: Proton Therapy+PD-1 Ab|combination of proton radiotherapy with PD-1 antibody
15885117|NCT03765177|Biological|CLIC-1901|Participants will undergo (a) lymphodepletion with cyclophosphamide and fludarabine, followed by (b) infusion of autologous CLIC-1901 CAR-T cells. All treatments will be delivered intravenously.
15885118|NCT03765164|Diagnostic Test|GlycoMark 1-5-AG|Online educational materials on GlycoMark 1,5-AG and sample test results for simulated patients
15885119|NCT03765164|Other|Clinical Performance and Value Vignettes|Simulated diabetic patients cared for online
15885120|NCT03765151|Device|low-level laser therapy|LLLT will be performed by a diode gallium-aluminum-arsenide (Ga-Al-As) laser with a 940-nm wavelength (Ezlase; Biolase Technology Inc., Irvine, CA) and delivered by a quadrant-sized probe which cover the region from the central incisor to the first molar on the test side. The laser probe will be 1 cm from the soft tissue around the test tooth at the gingival margin and alveolar mucosa covering the root area using a setting of 800 milliwatt in a continuous wave. Each tooth will receive 30 seconds of exposure, with no more than 8.6 J/cm2 of energy delivered. In addition, a spot-size laser probe will be applied for 30 seconds 5 mm from the cervical dentin with an output power of 700 milliwatt to reduce tooth sensitivity.
15886834|NCT03752138|Drug|Expansion Phase Decitabine|Expansion cohort will receive the RP2D of Decitabine
15885121|NCT03765151|Other|orthodontic retention|All participants included will wear fixed lingual retainer and removable retainers in the post-orthodontic retention period and their previous orthodontic treatment will be carried out by one operator using preadjusted appliances with bonded 0.022×0.028-inch2 brackets/buccal tubes and 0.014-inch Nickel Titanium (NiTi) archwires as the first archwires.
15885122|NCT03765138|Combination Product|PE/Pramipexole|"Experimental: PE/Pramipexole Prolonged Exposure (PE) Therapy consists of 10 sessions of 90-minute duration, normally conducted once a week. Elements of PE include imaginal and in vivo exposure to trauma reminders; breathing retraining; cognitive restructuring; and PTSD psychoeducation.
~Pramipexole: In addition to receiving PE as described above, patients will have Pramipexole treatment. Daily dose will be started at 0.25 mg/day and increased by 0.25 mg/day every 3-4 days to a target of 2.5mg day by week 5. Beginning week 6 daily dose will be increased weekly by 0.5 mg/day to a maximum dose of 4mg. Dose will be increased as tolerated unless the patient has achieved remission and will be decreased in the event of intolerable adverse events."
15885123|NCT03765125|Dietary Supplement|collagen peptide test|Collagen peptides from bovine skin with an average molecular weight of approx. 2,000 g/mol. Average particle size is about 150 μm.
15885124|NCT03765125|Dietary Supplement|collagen peptide placebo|collagen peptide placebo
15885125|NCT03765112|Device|Optical coherence tomography angiography|Multiple scans of the retina will be recorded to evaluate microvascular changes.
15885126|NCT03765099|Behavioral|Animal-Assisted Interactions|Child and caregivers randomly assigned to the intervention group will spend approximately 15 min with a registered canine and its owner during potentially anxiety-producing visits to the hospital.
15885127|NCT03765086|Procedure|Karydakis procedure|Pilonidal sinus will be excised by Karydakis procedure
15885128|NCT03765086|Procedure|Limberg Flap|Pilonidal sinus will be excised by Limberg Flap
15885129|NCT03765073|Biological|Multivalent Group B streptococcus vaccine|Various formulations at three dose levels
15885130|NCT03765073|Biological|Placebo|Saline control
15885131|NCT03765060|Procedure|Monomax® 2/0 HR26|"It will be use a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 2/0 with HR 26 needle.
~In the technique should be given at least 2 points for each wound cm, with a distance to the alba line of 0'5cm and 0'5 cm of separation between stitches. The closure starts from both ends, ending in the middle of the laparotomy with an overlap of at least 2 cm. The ratio between the length of the suture and the length of the wound should be at least 4:1."
15885132|NCT03765060|Procedure|Monomax® 1 HR48|"It will be use a very long-term monofilament absorbable synthetic suture of Poly-4-hydroxybutyrate (Monomax) 1 with HR 48 needle.
~In the technique should be given 1 point for each wound cm, with a distance to the alba line of 1 cm and 1 cm of separation between stitches. The closure starts from both ends, ending in the middle of the laparotomy with an overlap of at least 2 cm. The ratio between the length of the suture and the length of the wound should be at least 4:1."
15885133|NCT03765047|Behavioral|Intervention Arm|"The physical activity intervention consists of:
~School Engagement and Assessment - Based on the customized assessment, training is provided for school staff to develop the capacity to increase PA. A school PA team is established.
~Training - School teams are provided with ongoing in-person and virtual training to learn strategies for increasing PA before and during the school day. A training summit meeting will occur each summer, starting with the summer prior to the intervention. Teams will create a weekly calendar of activities to increase PA time to a minimum of 40 mts/day.
~PA Equipment and Resources - After training, schools are provided with PA equipment, resources and teaching aids to facilitate the integration of PA into the school day.
~Ongoing Assessment and Technical Assistance - Student accelerometer data will allow for monitoring of PA levels, so that additional technical assistance for classroom teachers can be provided if needed"
15885134|NCT03765034|Behavioral|Constrain-induced Movement Therapy|8-week therapy program utilizing constraint of the unaffected arm
15885135|NCT03765034|Behavioral|Usual Occupational Therapy|8-week therapy program without constraint of the unaffected arm
15885136|NCT03765021|Drug|Tranexamic Acid|One side of the face will be assigned to TXA intradermal microinjection using Kapron 500mg/5ml ampoules (Amoun Pharmaceutical Company), the dose of 1 ml syringe with 100mg/ml. TXA will prepared under sterile conditions. Injections will be applied intradermally on hyperpigmented areas at 1cm intervals. The injection will be repeated every two weeks for three months.
15885137|NCT03765021|Device|Fractional CO2 laser|The other side of the face will be randomly assigned to low power fractional CO2 laser with a power of 12 watts, spacing 700 micrometers (low density), and dwell time 300 microsecond every four weeks for three months.
15885138|NCT03765008|Other|Water intake manipulation|for 5 days prior to each experiment subjects will undergo manipulation of their water intake.
15885139|NCT03764995|Other|Standard bowel management|Lifestyle advices such as increasing fluid and fibre intake, improving physical activity level, and taking the ideal posture for defecation (squatting position) with a two-pages document.
15885140|NCT03764995|Other|Abdominal massage|Abdominal massage will be performed three days a week for four weeks. Each session will last around 15-20 minutes.
15885141|NCT03764995|Other|Placebo Ultrasound|Placebo ultrasound (US) will be applied to the abdominal region for four weeks, 2 days of the week and 15 minutes per day.
15885142|NCT03764969|Behavioral|standard smoking cessation program (SCP)|Each subject will receive standard SCP as group treatment once a week (1 hour) over six weeks. This group therapy is based on behavioural therapy and a psycho-educational approach (for more details see Batra & Buchkremer 2004), and will be carried out by a qualified therapist.
15885143|NCT03764969|Behavioral|Cognitive remediation treatment (CRT)|Cognitive remediation treatment (CRT) employing a chess-based battery of tasks two times per week over six weeks as a group treatment in our outpatient clinic (60 min duration per session).
15885144|NCT03764969|Behavioral|Implicit computer-based habit-modifying training (ICHT)|Implicit computer-based habit-modifying training (ICHT), applied twice a week for six weeks. In this training, the participants perform a two-part training. First, a subliminal presentation (20 ms) of negative valenced primes before smoking-cues in context and secondly, a subliminal presentation of positive valenced primes before potentially reinforcing events.
15885145|NCT03764956|Other|Low glycemic Index Therapy (LGIT)|Specific dietary therapy called Low glycemic Index Therapy (LGIT) which provides diet including food items with glycemic index less than 50 only. For this purpose, various dietary menus will be provided to the parents.
15886835|NCT03752138|Drug|Part 2: TK216|Recommended dose from Part 1.
15885146|NCT03764956|Other|Modified Atkins Diet (MAD)|Specific dietary therapy called Modified Atkins Diet (MAD) which provides diet with restricted carbohydrates upto 20 grams per day and increased fat and protein ratio. For this purpose, various dietary menus will be provided to the parents.
15885147|NCT03764943|Dietary Supplement|Impact Advanced Recovery|immunonutrition shake; nutritional supplement containing amino acids, omega-3 fatty acids, and nucleotides
15885148|NCT03764930|Other|Unsuspected Retinoblastoma|To study the clinical characteristics and treatment outcomes of patients who experienced inadvertent trauma before diagnosis of retinoblastoma.
15885149|NCT03764917|Other|Time|Different detecting time
15885150|NCT03764904|Radiation|Airway Ultrasound|Laryngeal US will be performed with a 12 megahertz (MHz) linear probe attached to the ultrasound device. With the probe placed transversely on the midline of the anterior neck over the cricothyroid membrane.
15885151|NCT03764891|Procedure|Uphold|Uphold system in treating women with cystocele
15885152|NCT03764891|Procedure|Perigee|Perigee system in treating women with cystocele
15885153|NCT03764878|Diagnostic Test|functional MRI|Participants will undergo a functional MRI using multiple imaging modalities.
15885154|NCT03764865|Procedure|day 3 uterine transfer|uterine transfer of embryo on day 3 after fertilization (cleavage stage)
15885155|NCT03764865|Procedure|day 5 uterine transfer|uterine transfer of embryo on day 5 after fertilization (blastocyst stage)
15885156|NCT03764852|Procedure|outpatient laparoscopic|The intervention is a outpatient laparoscopic sacrocolpopexy with robotic assistance.
15885157|NCT03764852|Procedure|outpatient laparoscopic|The intervention is a outpatient laparoscopic sacrocolpopexy without robotic assistance.
15885158|NCT03764839|Behavioral|"Perioperative Digital Behavioral Pian Medicine My Surgical Success"|"The My Surgical Success website include 45 minutes of psychoeducation material developed and delivered by Beth Darnall, PhD. Viewers learn basic skills to improve regulation of pain-related distress. Treatment includes an app and a personalized plan for surgical success."
15885159|NCT03764826|Device|CAABT|The sound generators with CAABT will be used 15 min each session, three times a day
15885160|NCT03764826|Device|TMT|The sound generators with TMT will be used 15 min each session, three times a day
15885161|NCT03764787|Combination Product|Radiation+PD-1 Ab|combination of proton radiotherapy with PD-1 antibody
15885162|NCT03764774|Drug|LY3463251|Administered SC
15885163|NCT03764774|Drug|Placebo|Administered SC
15885164|NCT03764761|Device|AAC Technology - Standard of Care|Story Book is separate from AAC symbols, AAC symbols are arranged on a grid with color backgrounds. This is non-optimal arrangement and non-integrated presentation
15885165|NCT03764761|Device|AAC Technology - non-optimal integrated arrangement|Story Book is integrated on to the AAC display together with the AAC symbols, AAC symbols are arranged on a grid with color backgrounds. This is non-optimal arrangement and but integrated presentation
15885166|NCT03764761|Device|AAC Technology - non-optimal integrated arrangement|Story Book is integrated on to the AAC display together with the AAC symbols, AAC symbols are arranged on a grid with color backgrounds. This is optimal arrangement and but integrated presentation
15885167|NCT03764748|Drug|mini-FMT|200ml selective microbiota suspension (namely mini-FMT, mixed species of cultured bacteria) will be delivered daily through the nasojejunal transendoscopic enteral tubing (TET) tube for 3 days.
15885168|NCT03764735|Drug|Low Dose - SkQ1|SkQ1 Low dose ophthalmic solution
15885169|NCT03764735|Drug|High dose - SkQ1|SkQ1 High Dose ophthalmic solution
15885170|NCT03764735|Drug|SkQ1 (Vehicle)|Vehicle for SkQ1 ophthalmic solution
15885171|NCT03764722|Drug|Levosimendan|"The patient will initially receive a standard dose of 0.1 mcg/kgmc/min. In case of good tolerance of the drug - the dose will be increased to 0.2 mcg/kgmc/min. If hypotension SBP <90 mmHg occurs, the dose will be reduced to 0.05 mcg / kgm / min. If the hypotension persists despite the reduction of the drug - the infusion will be terminated and the patient will be excluded from the study. The infusion will be terminated within 24 hours, the patient will be examined again 4 hours after the end of the infusion, by the attending physician and unless there are contraindications - discharged home.
~Patients will be hospitalized every 4 weeks for the next 6 months."
15885172|NCT03764709|Device|Vital signs wireless monitoring system|WIN@Hospital wireless remote monitoring is a modern light monitoring medical device with no need for continuous presence of a dedicated person. WIN@Hospital is based on an innovative modular and wearable device laid out for remote monitoring of several vital parameters 24/7. Dexcom G6 is a continuous glucose monitoring system which measures interstitial fluid glucose levels in people with diabetes from a sensor applied to the skin as an alternative to routine finger-prick blood glucose testing, and can produce a -continuous record of measurements which can be checked using an App. It can also indicate glucose level trends over time. Monitoring devices will be applied to all patients randomly assigned to the wireless monitoring arm, with a continuous monitoring setting over the first 5 days after the initiation of monitoring, corresponding to the starting of the observation (i.e. transition to subacute unit for GROUP A, discharge for GROUP B).
15885173|NCT03764696|Device|High flow facemask|Oxygen will be administered by facemask at 10 L/min oxygen. The therapy will continue until after delivery
15885174|NCT03764683|Drug|Suvorexant (Belsomra)|Suvorexant (Belsomra) is approved by the U.S. Food and Drug Administration (FDA) to treat insomnia. It has not yet been studied in people with bipolar disorder who have problems sleeping.
15885175|NCT03764683|Drug|Placebo|Subjects will take placebo capsules (containing no active substance) identical in appearance to those containing Suvorexant
15885176|NCT03764657|Procedure|"In hot group 16 patients were treated by diathermy in Cold"|"In all interventions, the patients were placed in prone position on operating table with the gluteal line opened wide by adhesive patches; after skin disinfection, dimension and extension of cystic disease was studied by injection of hydrogen peroxide through superficial skin orifice. The same procedure was performed: an elliptical incision on midline around the sinus was made and the sinus was excided laterally and in depth on healthy tissue, down till the pre-sacral fascia: this common approach was made both using scalpel and electrosurgery in the two groups. During dissection and excision, in each group were measured and recorded the temperatures developing, both on the section surface using an infrared thermometer and thermal imaging camera, and deeper until 1 cm from the section frontline using a immersion thermometer sealed by a steri-drape to guarantee the sterility on surgical field. In this group excision was carried out with diatermocoagulation"
15885177|NCT03764657|Procedure|"in Cold group 13 patients were treated by scalpel."|"the position and preparation of the patient on the operating table were the same as in the hot group, while the excision procedure performed with knife"
15885178|NCT03764644|Behavioral|Combined ABMT and CBT|ABMT: A trial begins with a fixation cross (+) for 500 ms, immediately followed by a stimuli pair consisting of a neutral and threatening stimulus that is centred horizontally. Stimuli pairs consist of two faces, pictures or words. After presentation of the stimuli pair, a probe (: or ..) always appears on the location of the neutral stimulus. The probe remains on the screen until the participant presses the corresponding key (: or ..), after which the next trial begins. Each session, participants see 160 trials of which 128 trials include one neutral and one threatening stimulus. The remaining 32 trials include a neutral-neutral stimuli pair. CBT: FRIENDS program individual
15885179|NCT03764644|Behavioral|Combined Sham ABMT and CBT|ABMT: A trial begins with a fixation cross (+) for 500 ms, immediately followed by a stimuli pair consisting of a neutral and threatening stimulus that is centred horizontally. Stimuli pairs consist of two faces, pictures or words. After presentation of the stimuli pair, a probe (: or ..) always appears on the location of the neutral stimulus. The probe remains on the screen until the participant presses the corresponding key (: or ..), after which the next trial begins. Of the 160 trials, the probe appears with equal frequency on the location of the neutral and threatening stimulus (128 trials). The remaining 32 trials include a neutral-neutral stimuli pair. CBT: FRIENDS program individual
15885180|NCT03764631|Drug|Empagliflozin|Drug
15885181|NCT03764631|Drug|Dipeptidyl-peptidase 4 (DPP-4) inhibitors|Dipeptidyl-peptidase 4 - Drug
15885182|NCT03764618|Drug|Fostamatinib disodium|"Fostamatinib (100mg PO bid or 150 mg PO bid)
~The dose may be reduced at any time to a dose as low as fostamatinib 100 mg PO qd or matching placebo if dose limiting adverse events are observed."
15885183|NCT03764618|Drug|Placebo|Placebo
15885184|NCT03764605|Drug|Metformin|Patieny will be treated by using Metformin from 500 mg a day to 500 mg thrice a day.
15885185|NCT03764605|Drug|Tolvaptan|Patients will be treated with tolvaptan from 45 mg + 15 mg a day to 90 mg + 30 mg a day
15885186|NCT03764592|Other|radiofrequency ablation|Symptomatic patients whose substrates were identified will undergo catheter ablation; asymptomatic patients will be followed without undergoing catheter ablation.
15885187|NCT03764579|Behavioral|sleep and diet intervention vs diet intervention|lifestyle healthy food and use Harvard plate and reduce use electronic device prior sleep.
15885188|NCT03764566|Behavioral|Questionnaires|The intervention will include the implication of related questionnaires, followed by a lab experiment for social belonging with multiple modalities. Participants will be shown pictures of different faces and asked to judge their feelings towards them. Further, a VR task will include finding the way through a virtual maze with the help of two virtual characters.
15885189|NCT03764553|Drug|Liposomal Irinotecan|Iv liposomal irinotecan
15885190|NCT03764553|Drug|Carboplatin|IV Carboplatin
15885191|NCT03764553|Drug|Capecitabine|PO Capecitabine
15885192|NCT03764553|Drug|Oxaliplatin|IV Oxaliplatin
15885193|NCT03764553|Drug|5-fluorouracil|IV 5-fluorouracil
15885194|NCT03764553|Drug|Leucovorin|IV Leucovorin
15885195|NCT03764540|Drug|Cabazitaxel plus prednisone|"Cabazitaxel 25 mg/m² intravenously on day 1 of each cycle, plus prednisone 10 mg orally given daily.
~A cycle is defined as a 3-weeks period for a maximum of 10 cycles."
15885196|NCT03764540|Drug|Docetaxel plus prednisone|"Docetaxel 75 mg/m² intravenously on day 1 of each cycle, plus prednisone 10 mg orally given daily.
~A cycle is defined as a 3-weeks period for a maximum of 10 cycles."
15885197|NCT03764527|Drug|Artemether-lumefantrine|Two doses a day for 3 days, under supervision
15885198|NCT03764527|Drug|Coadministered Artesunate plus Amodiaquine|One dose a day for 3 days, under supervision
15885199|NCT03764514|Device|Spinal Cord Stimulator|Permanent Implantation
15885200|NCT03764501|Device|Image fusion system|Image fusion system for the 3D preoperative planning
15885201|NCT03764488|Drug|BIIB067|Administered as specified in the treatment arm.
15885202|NCT03764488|Drug|99mTc-MAG3-BIIB067|Administered as specified in the treatment arm.
15885203|NCT03764475|Drug|ARQ-151|ARQ-151 cream 0.3% applied once daily for 52 weeks
15885204|NCT03764462|Drug|AD-101 45mg|Raloxifene 45mg tablet
15885205|NCT03764462|Drug|Raloxifene 60mg|Raloxifene 60mg tablet
15885206|NCT03764449|Drug|Oral Balovaptan|"In Period 1, balovaptan was administered as a single oral dose.
~In Period 2, balovaptan was administered as an oral dose once daily on Day 1 to Day 14."
15885207|NCT03764449|Drug|IV Balovaptan|"In Period 1, IV infusion of balovaptan was administered after the balovaptan oral dose.
~In Period 2, IV infusion of balovaptan was administered after the final oral dose of balovaptan."
15885208|NCT03764436|Behavioral|LEAPS-NCHD Program|The LEAPS-NCHD program trains young women aged 18 - 24 years with a minimum of 10 years of basic education to be preschool teachers, or Community Youth Leaders (CYLs) in community-based preschools in rural Sindh. CYLs will receive two weeks of classroom-based basic-training and 6 months of on-the-job coaching and support. A maximum of 20 children aged 3.5 -5 years old will be enrolled in each preschool. One preschool will be opened per cluster (village). Children will receive a minimum of 6 months of program exposure between assessment rounds.
15885209|NCT03764423|Dietary Supplement|Salmon fishmeal|Salmon fishmeal with high protein content
15885210|NCT03764423|Dietary Supplement|Microcrystalline cellulose|Microcrystalline cellulose contain no energy and is less fermented in the gut than other dietary fibers.
15885211|NCT03764410|Procedure|Non-surgical periodontal treatment|all the individuals included in the study received periodontal treatment with scaling and root planing with the use of local anesthesia and removal of factors that could cause biofilm retention such as fixed prosthesis, restorations, cervical abrasions. Four weekly sessions lasting 30 minutes each.
15885265|NCT03763929|Drug|Trans-Sodium Crocetinate|In the study drug kit containing the experimental drug (TSC), TSC will be reconstituted with the Sterile Water for Injection (USP) supplied in the same kit. There will be an unblinded paramedic who will reconstitute and inject the TSC on the ambulance.
15885266|NCT03763929|Other|Placebo|The study drug kit containing placebo (sterile saline for Injection) will be prepared and injected by the unblinded paramedic on the ambulance.
15885305|NCT03763591|Behavioral|Trauma Systems Therapy for Refugees Group Intervention|Psychological skills group for youth of refugee and immigrant backgrounds.
15885212|NCT03764397|Behavioral|Prehabilitation for behavioural change|The 4-week prehabilitation educational programme will consist of a meeting for one session (approximately 1 - 1.5 hours) per week. This behavioural change programme will involve a mixture of interactive and didactic sessions, facilitated by a physiotherapist, psychologists, and other health professionals. The purpose of the initial prehabilitation programme is to gain participant 'buy-in' to the programme, to assist participants engage with exercise, to help participants overcome barriers to exercise and improve self-efficacy for exercise. The prehabilitation phase will also enable participants to understand why and how to perform gentle self-paced exercise. After the prehabilitation programme, participants will be advised to engage in a 6-week gentle self-paced walking programme; i.e., a simple pedometer-driven walking programme with weekly telephone support.
15885213|NCT03764371|Diagnostic Test|KAPA Hyper Prep Kit + Agilent SureSelectQXT|We initiated this prospective clinical study to detect lung cancer related genes in tumor tissues and patients with at least 2 tumors that were confirmed as invasive adenocarcinoma by pathology after sMPLC resection (residual non-resectable or non-qualitative pulmonary nodules). At the same time, application of KAPA Hyper Prep Kit + Agilent SureSelectQXT technology to test lung cancer related genes in patients' tumor tissues and blood, patients with lung cancer drive genes were followed up to explore whether different drive genes had an impact on patients' disease progression. In order to investigate the type of gene that causes disease recurrence in patients, tissue or blood test was performed again when disease recurrence occur.
15885214|NCT03764358|Device|Arteriovenous Fistula|Surgical implantation of an arteriovenous fistula for hemodialysis
15885215|NCT03764358|Device|Tunneled Cuffed Catheter|Placement of a tunneled cuffed catheter in surgical theatre
15885216|NCT03764345|Drug|Sofosbovir/Lepipasvir (200/45mg) tablet (Heterosofir)|Patients receive oral daily dose of Sofosbovir/Ledipasvir (200/45mg) daily for 8 weeks
15885217|NCT03764332|Device|Stabilometry|To evaluate the static balance of subjects when barefoot and when using three types of footwear with their eyes closed or open.
15885218|NCT03764319|Other|Ultra-protective ventilator settings|4-5 Breaths per minute; 14-16 cmH2O Positive endexpiratory pressure (PEEP) (adjust PEEP to 23 < Plateau pressure < 25 cmH2O); 23-25 cmH2O Plateau pressure (adjust to not exceed Tidal volume > 4 mL/kg Predicted body weight (PBW)); < 4mL/kg PBW Tidal volume; 1:5 Inspiration:Expiration (I:E)
15885219|NCT03764319|Other|Standard ventilator settings|12-25 Breaths per minute; 8-12 cmH2O PEEP; max. 35 cmH2O Plateau pressure
15885220|NCT03764306|Procedure|Carotid Artery Stenting|Carotid artery stenting was considered successful if there was no residual stenosis greater than 20%, and there was no dissection of target artery following the procedure.
15885221|NCT03764306|Procedure|Endarterectomy carotid artery|Surgical endarterectomy was considered successful if there was no residual stenosis after procedure, without symptoms.
15885222|NCT03764293|Drug|SHR-1210|Subjects receive SHR-1210 intravenously, Dosage form: lyophilised powder, Strength: 200 mg /vial
15885223|NCT03764293|Drug|Apatinib|Subjects receive Apatinib orally, Dosage form: tablet, Strength: 250 mg/tablet
15885224|NCT03764293|Drug|Sorafenib|Subjects receive Sorafenib orally, Dosage form: tablet, Strength: 0.2 g/tablet
15885225|NCT03764280|Other|Multiple Daily Injections: Slow acting insulin and Rapid acting insulin|Multiple daily injections (MDI) therapy involves four or more daily insulin injections. Once or twice daily, a long acting insulin is injected as a basal dose. These long acting insulins are designed to dissipate slowly and evenly into the bloodstream for 24 to 36 hours following injection. This basal injection aims to mimic the physiological healthy basal insulin released from a healthy pancreas all day. Furthermore, multiple insulin bolus doses are injected at every meal each day using rapid or short acting insulin. These injections are administered before meals and are calculated using patients' ICRs and meal carbohydrate quantities.
15885226|NCT03764267|Drug|Remifentanil|"Five minutes before infiltration of the local anesthestic by the surgeon, patients received an initial maintenance infusion of remifentanil 0.1 µg/kg/min and ketofol mixture 0.3 ml/kg (propofol 25 µg /kg/min and ketamine 10 µg/kg/min). ketofol mixture was prepared in a ratio of 1:2.5 (100 mg ketamine 2 mL (100 mg), propofol 1% 25 mL (250 mg), and glucose 5% 23 ml, total volume of 50 ml, each ml contain 2 mg ketamine + 5 mg propofol).
~Throughout the surgery, titration of the infusion rate of the remifentanil and ketofol were indicated by vital signs and expression of pain"
15885227|NCT03764267|Drug|general anesthetic|general anesthetic was induced with a bolus dose of remifentanil (1 ug/kg over 30 second) and propofol (2 mg/kg) followed by insertion of a laryngeal mask airway (LMA). After the induction of anaesthesia and securing the airway, patient' lungs were ventilated with volume controlled ventilation, 50% oxygen/air mixtures in a circle system. .Anesthesia was maintained with remifentanil (0.5 ug/ kg/ min) and propofol (5 mg/kg/h). Remifentanil and propofol titrated to keep heart rate and the blood pressure within 20% of the baseline values and maintain BIS between 40 and 60, respectively. Patient movements were treated with additional i.v. bolus doses of remifentanil 0.5 ug/kg
15885228|NCT03764241|Drug|Rivaroxaban|Rivaroxaban 15mg/QD will be applied for 3 months unless severe safety outcome occurs. All patients in both group will take aspirin 100mg/QD, clopidogrel 75mg/QD and proton pump inhibitor during the intervention.
15885229|NCT03764241|Drug|Vitamin K Antagonist|warfarin (INR 2.0-2.5) will be applied for 3 months unless severe safety outcome occur. All patients in both group will take aspirin 100mg/QD, clopidogrel 75mg/QD and proton pump inhibitor during the intervention.
15885230|NCT03764228|Biological|hAECs|Human amniotic epithelial cells（hAECs）
15885231|NCT03764215|Drug|Nilotinib 150 MG|10 participants will receive an oral dose of 150mg Nilotinib once daily for 3 months (group 1). If this dose is tolerated another 10 participants will receive an oral dose of 300mg Nilotinib once daily (group 2) for 3 months.
15885232|NCT03764202|Other|Detection of sufentanil concentration|"Concentration of sufentanil in human breast milk was determined by LC-MS /MS method
~The volume of human breast milk was detected at each fixed time point"
15885233|NCT03764189|Procedure|microosteoperforation|small holes made using large round bur
15885267|NCT03763916|Procedure|Ureteric dissection|clamping and cutting the round ligament, clamping and cutting the ovarian ligament with ovarian preservation, careful dissection and clamping of the broad ligament varicosities, careful dissection of the post leaflet of the broad ligament until ureter is reached, careful dissection and exposure of both ureter and proper identification of the iliac vessels
15885306|NCT03763578|Other|Licorice|Natural herbal product
15885648|NCT03760835|Drug|Dual release hydrocortisone (plenadren)|Treatment of congenital adrenal hyperplasia
15885234|NCT03764176|Procedure|Conventional impressions|"In the conventional group, a polyether impression (ImpregumTM, 3M ESPE, Seefeld, Germany) will be taken with a customized tray (Diatray Top, Dental Kontor, Stockelsdorf, Germany). The impression will be poured with Gypsum IV Class Scale 5° (T6, Techim, Techim Group s.r.l., Arese, Italy) and then, the models mounted in a fully adjustable articulator (Protar Evo 7, KaVo Dental, Biberach, Germany). Afterwards, a dental wax-up will be made accordingly to the functional and esthetic requirements. Finally, master model and wax-up will be digitalized by using a lab scanner.
~A surgical template will be derived from the mounted casts (conventional group) and used to place the implants using guided surgery."
15885235|NCT03764176|Procedure|Digital impressions|"Patients will be randomly assigned to undergo intraoral digital impression (digital group) or conventional impression (conventional group). In the digital group, a digital impression will be taken using CS 3600 intraoral scanner (Carestream Dental LLC, Atlanta, GA, USA). The digital data (STL, STereo Lithography interface format) will be imported in a 3D design software to realize a virtual wax-up according to the functional and esthetic requirements.
~A surgical template will be derived from the virtual plane (digital group) and used to place the implants using guided surgery."
15885236|NCT03764163|Diagnostic Test|Pulmonary Function Test|Spirometry, Diffusing Capacity of the Lungs (DLCO), Lung Volumes
15885237|NCT03764163|Diagnostic Test|CT Scans|volume scans, perfusion scan, ventilation scan
15885238|NCT03764163|Behavioral|Questionnaires|Human Subjects Questionnaire, Baseline Dyspnea Index, Chronic Respiratory Questionnaire
15885239|NCT03764163|Diagnostic Test|MRI|proton scans, hyperpolarized 3-Helium scan
15885240|NCT03764163|Biological|Xenon gas|ventilation CT scans
15885241|NCT03764137|Drug|[89Zr]Panitumumab PET-MRI|All patients entered into the study will have [89Zr]Panitumumab-PET/MRI imaging.
15885242|NCT03764124|Diagnostic Test|PET/CT imaging|The PET/CT procedure was performed using cross-calibrated Philips Gemini TF Big Bore or TF 16 PET/CT systems (Philips Medical Systems, Cleveland, OH) at 201 18 minutes following intravenous injection of a mean dose of 3.2 0.2 MBq/kg of body weight of 18 F-FDG. A low-dose helical CT (5-mm slice thickness, 120-kV tube voltage, and 40-mAs tube current-time product) centered to the renal transplant was performed, followed by PET scanning with two bed positions, each lasting 240 seconds. Images were reconstructed using iterative list mode time-of-flight algorithms. Corrections for attenuation, dead time and random and scatter events were applied.
15885243|NCT03764111|Device|Large Mobile Ultrasound System|30 spine images, 15 Transverse abdominis muscle and 30 Obstetric images (i.e placenta, uterine blood flow, etc) images will be obtained using the large mobile ultrasound system.
15885244|NCT03764111|Device|Handheld Ultrasound Machine|30 spine images, 15 Transverse abdominis muscle and 30 Obstetric images (i.e placenta, uterine blood flow, etc) images will be obtained using the handheld device.
15885245|NCT03764098|Drug|Guanfacine ER|Guanfacine Extended Release (6mg/day ER)
15885246|NCT03764098|Other|Placebo|Placebo
15885247|NCT03764085|Drug|Rheosorbilact®|Administered intravenously (with speed 40-60 drip per minute) at a dose of 600 to 1,000 ml (10 to 15 ml/kg body weight per 24 hours) for 3 days.
15885248|NCT03764085|Drug|Ringer lactate|Administered intravenously (with speed 40-60 drip per minute) at a dose of 1,000 to 2,500 ml (15 to 40 ml/kg body weight per 24 hours) for 3 days.
15885249|NCT03764072|Drug|VX-150|Multiple doses for VX-150 will be administrated orally.
15885250|NCT03764072|Drug|Placebo|Subjects will receive placebo matched to VX-150 orally.
15885251|NCT03764059|Device|Filtek bulk fill posterior restoration|"The subjects will be assigned to either the investigational product (Filtek Bulk ) or the control product (Z350XT) per web-based randomization system.
~Immediately after restoration placement, at 1 week and 1 year postoperative, two evaluators from each site will perform an independent clinical assessment."
15885252|NCT03764059|Device|Filtek™ Z350XT Universal Restorative|Filtek™ Z350XT Universal Restorative (Z350 XT) will serve as the control in this study.
15885253|NCT03764033|Behavioral|Impact of Killing (IOK)|Participants in this arm will receive 10 sessions (60-90 minutes) of a cognitive-behavioral moral injury treatment called IOK .
15885254|NCT03764033|Behavioral|Present Centered Therapy|Participants in this arm will receive 10 sessions (60-90 minutes) of a PTSD treatment that does not focus on trauma or cognitive restructuring, but rather the functional impact of trauma called Present Center Therapy (PCT)
15885255|NCT03764020|Drug|Placebo oral capsule/placebo comparator|3 mg placebo capsule one hour before bedtime for three weeks along with life style modification according to ACC/AHA 2013 guideline
15885256|NCT03764020|Drug|Melatonin/experimental|Melatonin ,capsule, 3 mg, one dose one hour before bedtime, for three weeks along with life style modification according to ACC/AHA 2013 guideline.
15885259|NCT03763981|Procedure|prolene seton treatment|patients with perianal fistulas will treated with seton placement by prolene thread
15885260|NCT03763981|Procedure|silk seton treatment|patients with perianal fistulas will treated with seton placement by silk thread
15885261|NCT03763968|Other|treatment and outcome|
15885262|NCT03763955|Behavioral|MIRT|"4 week MIRT provide:
~front to front treatment (1 hour/day for 5 days/week)
~treatment with robotic devices (1 hour/day for 5 days/week)
~occupational therapy (1 hour/day for 5 days/week)"
15885263|NCT03763942|Behavioral|HealthMindr App|Participants in the intervention arm will receive access to the HealthMindr app with basic prevention services (HIV test planning and test locators; risk assessment; HIV treatment locators; and condom, HIV test kit, and at-home STI specimen collection kit distribution) plus monthly PrEP eligibility assessments, PrEP provider locator, enhanced information about PrEP, and referrals to local PrEP navigators. The app also provides information about obtaining health insurance coverage and paying for PrEP.
15885264|NCT03763942|Behavioral|Control App|Men in the control arm will have access to an app with information pertinent to their participation in the study, including a study events timeline. The app will also allow participants and study staff to communicate via a messaging feature. The control arm app will not contain HIV prevention information.
15885303|NCT03763617|Device|d-ptfe membrane|Socket preservation using d-ptfe membrane to inhibit the formation of osteoclasts
15885268|NCT03763916|Procedure|Preoperative ureteric stenting|preoperative insertion of ureteric catheters is performed by the urologist in our team just before the start of cesarean hysterectomy. Patient is positioned in lithotomy, cystoscopy [Karl storz] is done to identify the ureteric orifices. ureteric catheters [Roche] are inserted followed by the insertion of Foley's urethral catheter
15885269|NCT03763916|Procedure|Cesarean hysterectomy|lateral dissection of the uterus is completed from the pelvic side wall, followed by very CAREFUL BLADDER DISSECTION. Finally clamping of the uterine vessels is done below the level of the placenta with or without complete removal of the cervix. Closure of the uterine stump is performed followed by CAREFUL HEMOSTASIS then closure of the abdomen is performed after leaving two wide bore drains
15885270|NCT03763903|Other|3D training|Skills (FLS tasks) training using 3D visualization
15885271|NCT03763903|Other|2D training|Skills (FLS tasks) training using 2D visualization
15885272|NCT03763890|Device|Post-end-Expiratory pressure|Titrate the PEEP from 24 cmH2O to 6 cmH2O, 2 cmH2O/step and record EIT, trans-pulmonary pressure, hemodynamic parameter and Blood-gas analysis.
15885275|NCT03763864|Other|Skin Biopsy|Skin Biopsy
15885276|NCT03763851|Radiation|Active PPP005|Group assigned to active PPP005 in the randomized placebo-controlled trial
15885277|NCT03763851|Radiation|Radiotherapy|Palliative RadioTherapy to the symptomatic site
15885278|NCT03763838|Other|Acupressure|Six weeks of daily self-administered relaxing acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure on the appropriate points on their bodies. These are points that are recognized as effective in Traditional Chinese Medicine (TCM).
15885279|NCT03763838|Other|Sham acupressure|Six weeks of daily self-administered sham acupressure. Instructions will be provided for how to perform acupressure on self. A tool (AcuWand) will be provided to help participants apply the right amount of pressure; however, the points that participants are instructed to use are not known to have any effect on the body.
15885280|NCT03763838|Other|Standard of Care|Fatigue management provided by participants' health care providers.
15885281|NCT03763825|Behavioral|Mini-AFTERc|Structured 30-45 minute telephone discussion based on health psychology theory and CBT principles.
15885282|NCT03763812|Procedure|Endovascular Aneurysm Repair (EVAR)|"The following blood samples will be taken: WBC and circulating cytokines (TNF-α, Interleukin (IL)-1, 1RA, 6, 10, 18, CRP), Troponin T, HsTnT, NT-pro-BNP at these time points:
~Before induction of anesthesia
~At wound closure
~24 hours after surgery
~48 hours after surgery
~1 month after surgery
~6 months after surgery
~12 months after surgery"
15885283|NCT03763812|Procedure|Endovascular Aneurysm Sealing (EVAS)|"The following blood samples will be taken: WBC and circulating cytokines (TNF-α, Interleukin (IL)-1, 1RA, 6, 10, 18, CRP), Troponin T, HsTnT, NT-pro-BNP at these time points:
~Before induction of anesthesia
~At wound closure
~24 hours after surgery
~48 hours after surgery
~1 month after surgery
~6 months after surgery
~12 months after surgery"
15885284|NCT03763799|Procedure|PCR-based microbiological diagnosis strategy|A multiplex PCR-based testing, will be used in addition to standard microbiological culture of the tracheal aspirate to diagnose bacterial pneumonia after inhalation
15885285|NCT03763799|Procedure|Standard microbiological diagnosis strategy|Standard strategy will be based on with standard microbiological culture of the tracheal aspirate to diagnose bacterial pneumonia after inhalation
15885286|NCT03763786|Drug|Cetrorelix Acetate|Used a standard
15885287|NCT03763760|Drug|Dexamethasone|An intravenous bolus dose of dexamethasone given prior to surgery.
15885288|NCT03763747|Device|Scoreflex NC Scoring PTCA catheter|To dilate coronary arteries during the subject's index procedure with Scoreflex NC Scoring PTCA catheters
15885289|NCT03763734|Drug|Dexamethasone|An intravenous bolus dose of dexamethasone given prior to surgery.
15885290|NCT03763721|Device|intraoperative optical coherence tomography (iOCT)|"The OCT technology is fully integrated in a conventional ophthalmic surgical microscope (Zeiss LUMERA 700 platform). The OCT consists of A-scans (length/thickness) and B-scans (X-Y plane) to create the three dimensional image. Alternatively C-scans (3D cube scans) are available. All scans are non-invasive. The surgeon can continue surgery whilst using the iOCT and view a live image projected in the binocular or on the external screen and the video stream can be recorded as well.
~The iOCT features are controlled using the foot paddle and the images are recorded on device. Investigations will be performed in a standardized matter: iOCT imagery and cube-scans after graft insertion, air injection, and the end of surgery."
15885291|NCT03763708|Device|Spinal Cord Stimulation|Programming
15885292|NCT03763695|Other|Measures for the VAP prevention in the PICU|Oral hygiene care (i.e chlorhexidine swab); clean and dry ventilator circuits; head positioning at 45 degrees.
15885293|NCT03763695|Other|Evaluation of VAP incidence before the protocol introduction|evaluation of VAP incidence in our pediatric population of intensive care patients before the implementation of the protocol for VAP prevention
15885294|NCT03763682|Device|Genio(TM) bilateral hypoglossal nerve stimulation system|Subjects will be consented, enrolled and eligibility criteria checked. If the subject is eligible, subject will proceed with the Genio(TM) implant implantation. Six (6) weeks after implantation, the implant will be activated and the subject will be assessed at 1 month plus 1 week, 2, 3, 4, 5 and 6 month(s) after implantation
15885295|NCT03763669|Dietary Supplement|Myoinositol|myo-inositol (2 g. twice a day)
15885296|NCT03763669|Dietary Supplement|Placebo (for myoinositol)|(twice a day)
15885297|NCT03763656|Drug|Hydroxyurea|Oral Hydroxyurea
15885298|NCT03763643|Drug|Rituximab|Rituximab 375mg/m2 intravenous on day 0 or -1 prior to kidney transplant
15885299|NCT03763643|Drug|Placebo|1.5 volume exchange plasmapheresis with fresh frozen plasma replacement
15885300|NCT03763643|Procedure|Plasmapheresis|1.5 volume exchange plasmapheresis with fresh frozen plasma replacement
15885301|NCT03763630|Drug|House dust-mite SLIT|received 2000 standard treatment units of glycerinated HDM allergen extract (ALK-AbellÓ) per day. Normal saline was administered to the placebo group. 11 µg of HDM allergen (equal parts of Dermatophagoides pteronyssinus and Dermatophagoides farinae) administered twice daily as oral drops.
15885302|NCT03763630|Drug|Normal saline|Normal saline administered in same frequency and manner as intervention
15885649|NCT03760822|Drug|Ramucirumab|IV ramucirumab at 8 mg/kg on D1 and D15
15885307|NCT03763565|Biological|Bivalent or Quadrivalent HPV vaccines|Vaccination with at least one dose of Bivalent or Quadrivalent HPV vaccines at least 5 years ago at the ages of 20-45 years
15885308|NCT03763552|Other|arthroscopic wrist arthrodesis|Cases of midcarpal wrist arthritis treated surgically with arthroscopic partial wrist fusion with cannulated screws
15885309|NCT03763539|Procedure|SWL|Shock wave lithotripsy
15885310|NCT03763513|Device|ESWT|Extracorporeal Shock Wave Therapy=ESWT
15885311|NCT03763513|Other|Kinesiotaping Application|Kinesiotaping=KT (CT)
15885312|NCT03763500|Other|Internet-based education|A six-step Internet-based patient education.
15885313|NCT03763487|Diagnostic Test|venous blood sampling|Venous blood samples to determine memory B lymphocytes.
15885314|NCT03763487|Procedure|spleen volumetry|Ultrasound examination of spleen to scaled the size.
15885315|NCT03763474|Combination Product|Euglyca application|'Euglyca' is a mobile application developed by two of the authors (CC and DF). The application has a data base of 7000 foods and food products met in greek eating habits as well as the corresponding amount of carbohydrates and lipids for each of them. Subsequently, the amount of carbohydrates and lipids contained in a meal are calculated automatically by the application. By taking into consideration the amount of carbohydrates and lipids to be consumed, the preprandial and target post-prandial glycemia concentrations, the insulin correction factor for the patient, the carbohydrates and lipids factors and the active insulin (in case of CSII), 'Euglyca' calculates the required bolus dose of insulin.
15885316|NCT03763461|Device|HFNC|High flow nasal humidified oxygen HFNC is an air-oxygen blender, which provides high flow (up to 60 L/min) of warmed (36°C) and humidified gas through nasal cannula, allowing tighter control of FiO2 from 0.2 to 1.0.
15885317|NCT03763461|Device|Oxygen Mask|Application of oxygen during conscious sedation
15885318|NCT03763448|Procedure|Infrapatellar Fat Pad preservation|In the IPFP preservation group, IPFP (more than 80%) will be preserved by retracting out of the operative field.
15885319|NCT03763448|Procedure|Infrapatellar Fat Pad resection|In the IPFP resection group, more than 80% IPFP will be resected during the total knee arthroplasty.
15885320|NCT03763435|Behavioral|Antenatal pregnancy classes|At least three comprehensive full-day educational program covering all the stages of pregnancy.
15885321|NCT03763422|Drug|Temozolomide|Oral Administration of Temozolomide
15885322|NCT03763422|Radiation|Radiotherapy|50.4 Gy in 28 fractions over 6 weeks
15885323|NCT03763422|Procedure|Surgery|Surgery
15885324|NCT03763409|Drug|Losartan Potassium|active drug
15885325|NCT03763409|Other|placebo|placebo
15885326|NCT03763396|Drug|Ketoconazole (KCZ)|Oral Tablet
15885327|NCT03763396|Drug|Posaconazole (PCZ)|Delayed Release Oral Tablet
15885328|NCT03763383|Procedure|Lateral Arm Flap|Its a kind of flap that is harvested from the lateral aspect of the arm to cover defects in different parts of the body
15885329|NCT03763370|Drug|Belantamab mafodotin (GSK2857916) anti-BCMA-immunoconjugate|Dose and schedule: belantamab mafodotin 2.5 mg/kg IV Q3weeks
15885330|NCT03763357|Device|Heat Therapy (HT)|Water at 42-43 degrees C will be circulated through the water circulating trousers to obtain calf skin temperature 39 degrees C followed by PET/CT imaging of generator-based 62Cu-ETS.
15885331|NCT03763344|Behavioral|Perceptual Cognitive Training (PCT)|Perceptual Cognitive Training (PCT) will be performed by having individuals work with a visual perceptual training software program called NeuroTracker. This device uses Multiple Object Tracking at increasing difficulties to develop high-level brain functions critical to recovery & cognitive health. By increasing in difficulty with each correct response and decreasing in difficulty when mistakes are made, brain function is constantly challenged. Each session (6 mins) delivers a series of mini-tests where the patient needs to remember key targets, then track them moving among distractors for several seconds and then identify them. Simple to do, but always challenging, NeuroTracker adaptively optimizes difficulty to each patient's level, maximizing cognitive stimulation every step of the way.
15885332|NCT03763331|Device|Control/Sham Treatment|Thermoneutral water will be circulated through water-circulating trousers to maintain skin temperature at baselines levels daily for 90 minutes for 8 weeks.
15885333|NCT03763331|Device|Heat Therapy|Water at 110 degrees F will be circulated through water-circulating trousers daily for 90 minutes for 8 weeks.
15885334|NCT03763318|Biological|EQ001|Itolizumab [Bmab 600])
15885335|NCT03763318|Biological|EQ001 Placebo|EQ001 Placebo
15885336|NCT03763305|Drug|Propofol continuous infusion|Propofol intravenous continuous infusion for anesthetic induction and maintenance
15885337|NCT03763305|Drug|Remifentanil|Remifentanil intravenous continuous infusion for anesthetic induction and maintenance
15885338|NCT03763305|Drug|Sevoflurane|Study participants receive fentanyl 1mcg/kg and propofol 1.5~2mg/kg for induction of general anesthesia. For maintenance of anesthesia, desflurane is used to maintain 1 age-related minimum alveolar concentration (MAC).
15885339|NCT03763305|Drug|Desflurane|1 age-related minimum alveolar concentration (MAC) of desflurane inhalation for anesthetic maintenance
15885340|NCT03763305|Drug|Propofol bolus injection|Propofol intravenous injection for anesthetic induction
15885341|NCT03763305|Drug|Fentanyl|Fentanyl intravenous injection for anesthetic induction
15885342|NCT03763292|Behavioral|Specific information brochure|A purpose-designed brochure about anesthesia and surgery in the ear in children is developed by the investigators. This brochure has photos and describes the procedures the child is going through.
15885343|NCT03763279|Combination Product|Triclosan-coated barbed suture|Use of Triclosan-coated Polydioxanone barbed suture
15885344|NCT03763279|Combination Product|Triclosan-coated monofilament suture|Use of Triclosan-coated Polydioxanone monofilament suture
15885345|NCT03763279|Device|Monofilament suture|Use of Polydioxanone monofilament suture
15885346|NCT03763266|Other|1 day low residue diet|Patients are interviewed and instructed by a nurse prior the colonoscopy. They receive oral and written dietary information. In case of morbidity associated with bad preparation they are given bisacodyl the night before the colonoscopy.
15885347|NCT03763266|Other|3 day low residue diet|Patients are interviewed and instructed by a nurse prior the colonoscopy. They receive oral and written dietary information. In case of morbidity associated with bad preparation they are given bisacodyl the night before the colonoscopy.
15885440|NCT03762460|Other|Informational website|Participants randomized to this group will receive information about online resources for mental health
15885348|NCT03763253|Combination Product|Standard of Care|Androgen deprivation with or without docetaxel chemotherapy, Abiraterone, Enzalutamide or any other proven agent) treatment as determined by treating physician (positive control).
15885349|NCT03763253|Procedure|Minimally Invasive Ablative Therapy (MIAT)|"MIAT includes High intensity focused ultrasound (HIFU) or Cryotherapy to the prostate.
~Metastatic Directed Therapy available for use."
15885350|NCT03763253|Procedure|Radical Therapy (Prostatectomy or Radiotherapy)|"Radical therapy includes: Prostatectomy (any surgical approach) or External beam radiotherapy (High dose).
~Metastatic Directed Therapy available for use."
15885351|NCT03763240|Dietary Supplement|BSE|"BSE powder will be provided as dry mixtures in sealed, non-transparent portion size bags. Each BSE bag contains 150 μmole, equal to 0.26 g, sulforaphane at a minimum. The mixtures are suspended with appr. 1 dl water and are ingested once daily in the morning. BSE should be stored at room temperature in dry conditions.
~The doses of sulforaphane contained in the BSE is not possible to get by eating fresh broccoli, thus it has to be given as an extract."
15885352|NCT03763240|Dietary Supplement|Placebo|Placebo powder will be provided as dry mixtures in sealed, non-transparent portion size bags. The mixtures are suspended with appr. 1 dl water and are ingested once daily in the morning.
15885353|NCT03763227|Drug|Intravitreal ranibizumab (IVR) injection|Intravitreal ranibizumab (IVR) injection in patients with retinal dystrophy and macular cysts who have not responded to treatment with carbonic anhydrase inhibitors
15885354|NCT03763227|Drug|Carbonic Anhydrase Inhibitor (CAI) therapy|Carbonic anhydrase therapy (Oral or Topical) in patients with retinal dystrophy and macular cysts
15885355|NCT03763214|Device|Stenting with PTFE-coated stent (HILZO)|Placing a metal stent in the biliary tract by duodenoscopy
15885356|NCT03763201|Diagnostic Test|measurement of GITR|serum and synovial fluid measurement of glucocorticoid-induced tumour necrosis factor receptor related protein
15885357|NCT03763188|Other|Use of daily urinary urea excretion|Weaning dialysis catheter
15885358|NCT03763175|Drug|SYN-010 21 mg|21 mg lovastatin will be administered to patients diagnosed with IBS-C to evaluate whether the medication and dose is effective in increasing frequency of completely spontaneous bowel movements. The secondary objectives of the study are to assess the role of lovastatin lactone in increasing overall stool frequency and reducing abdominal pain severity, bloating severity, and rescue medication use. Additional endpoints include improvement in reported adequate relief and the effect of the study drug in lowering exhaled methane levels.
15885359|NCT03763175|Drug|SYN-010 42 mg|42 mg lovastatin will be administered to patients diagnosed with IBS-C to evaluate whether the medication and dose is effective in increasing frequency of completely spontaneous bowel movements. The secondary objectives of the study are to assess the role of lovastatin lactone in increasing overall stool frequency and reducing abdominal pain severity, bloating severity, and rescue medication use. Additional endpoints include improvement in reported adequate relief and the effect of the study drug in lowering exhaled methane levels.
15885360|NCT03763175|Drug|Placebo|A placebo will be administered to patients diagnosed with IBS-C to evaluate whether the medication and dose is effective in increasing frequency of completely spontaneous bowel movements. The secondary objectives of the study are to assess the role of lovastatin lactone in increasing overall stool frequency and reducing abdominal pain severity, bloating severity, and rescue medication use. Additional endpoints include improvement in reported adequate relief and the effect of the study drug in lowering exhaled methane levels.
15885361|NCT03763162|Drug|Bortezomib|Given SC
15885362|NCT03763162|Biological|Daratumumab|Given IV
15885363|NCT03763162|Drug|Dexamethasone|Given IV or PO
15885364|NCT03763162|Drug|Ixazomib|Given PO
15885365|NCT03763162|Other|Quality-of-Life Assessment|Ancillary studies
15885366|NCT03763149|Biological|IBI188|"The study is composed of two stages: Part 1 Accelerated Titration Phase and Part 2 Dose Escalation Phase with initial fixed priming dose.
~The starting dose for part 1 is 0.1 mg/kg QW, followed by 2 dose cohorts (0.3 mg/kg QW and 1 mg/kg QW). Duration of dose limiting toxicity (DLT) observation is 28 days.
~Part 2 will have 4 dose cohorts(3mg/kg QW、10mg/kg QW、20mg/kg QW and 30mg/kg QW). Conventional 3+3 Dose Escalation will be adopted. DLT observation period is 28 days."
15885367|NCT03763136|Biological|hPSC-CM Therapy|Injection of allogenic human pluripotent stem cell-derived cardiomyocytes (hPSC-CMs) during coronary artery bypass grafting surgery. 200 million hPSC-CMs in 2.5-5 mL medium suspension will be injected into the myocardium.
15885368|NCT03763123|Drug|Sevacizumab|Drug: Sevacizumab escalating doses of Sevacizumab : 0.5mg/kg，1mg/kg，1.5mg/kg and 2mg/kg
15885369|NCT03763123|Drug|Paclitaxel|paclitaxel 80mg/m2 as a > 3-hour IV infusion on days 1, 8,15, and 22 every 4 weeks;
15885370|NCT03763123|Drug|Topotecan|topotecan 4 mg/m2 as a >30 minute IV infusion on days 1, 8, and 15 every 4 weeks ;
15885371|NCT03763110|Device|Photo Activated Disinfection|Photoactivated disinfection (PAD) is based on the interaction of a photosensitive antibacterial agent and a light source. It uses a nontoxic dye [named photosensitizer PS] and low-intensity visible light. In oxygen presentation, these combine to produce some cytotoxic species. The PS molecules attach to bacteria membrane
15885372|NCT03763110|Drug|antibiotic paste|"An antibiotic mixture composed of ciproﬂoxacin, metronidazole, and minocycline, known as triple antibiotic paste (TAP) or 3mix, has been the most widely used medicament, This goes back to the studies by Hoshino et al.1996"
15885373|NCT03763097|Diagnostic Test|Pelvic floor ultrasound|Pelvic floor ultrasound will include transperineal and introital ultrasound
15885374|NCT03763084|Drug|Acetaminophen|For patients in the acetaminophen group, oral acetaminophen supplemented dexmedetomidine sedation will be provided after surgery.
15885375|NCT03763084|Drug|Sufentanil|For patients in the control group, sufentanil supplemented dexmedetomidine sedation will be provided after surgery.
15885376|NCT03763071|Other|Patient-reported scales to measure sleep disorders|"Patient-reported scales to measure sleep disorders include below mentioned scales:
~Pittsburgh Sleep Quality Index; measures the quality of sleep Berlin Questionnaire; measures the obstructive sleep apnea Stop-Bang questionnaire; measures the obstructive sleep apnea Insomnia Severity Index; measures the insomnia and related parameters"
15885441|NCT03762447|Drug|INCB086550|INCB086550 will be orally administered once or twice daily in continuous or intermittent dose schedules.
15885471|NCT03762239|Other|Purifying the air with a Pure Airbox device (Zonair 3D)|Purifying the air of the classroom where the experiment is conducted using a Pure Airbox device (Zonair 3D)
15885377|NCT03763058|Other|Music Therapy|"The music intervention is administered via a smartphone- (and computer-) based application called Music Care. The Music Care app is a receptive music intervention, allowing the patient to freely adjust the length of and choose the preferred style between different sequences of instrumental music. All musical pieces were recorded in high-quality recording studios with professional musicians. Music Care utilizes the U technique designed to gradually relax the listener. The U technique is implemented using a musical sequence of 20 minutes that was divided into 5 different musical pieces at 3 to 4 minutes each.
~Participants will complete 1-2 sessions of listening to music per day, with a minimum of 15 sessions per month."
15885378|NCT03763045|Drug|Sildenafil|Sildenafil 25 mg: Phosphodiesterase inhibitor to be taken once daily
15885379|NCT03763045|Drug|Sildenafil|Sildenafil 50 mg: Phosphodiesterase inhibitor to be taken once daily
15885380|NCT03763045|Other|Placebo|Placebo tablet.
15885381|NCT03763032|Behavioral|Counseling|The patient navigator will provide educational materials, assessments, and counseling to the patients
15885382|NCT03763019|Procedure|Conventional rehabilitation|Static and dynamic control of position, balance skills, weight shift, and activities of daily living.
15885383|NCT03763019|Procedure|Respiratory rehabilitation|Forced expiration, forced inspiration (thoracal expansion exercise), coughing exercise, incentive spirometric trainer, diaphragmatic respiration exercise, autogenic drainage, percussion.
15885384|NCT03763006|Procedure|Eyelid cleaning|This is a pure hypochlorous acid that kills many microbes, but remain very friendly and non-toxic for the ocular surface.
15885385|NCT03762993|Behavioral|Vocal rest and Controlled Phonation|Voice rest and semi occluded vocal tract voice exercises
15885386|NCT03762980|Other|Bilateral training (BAT)|Each group received bilateral training) for upper extremities for 3 days per week for 01 hour/day for up to 6 weeks. Tasks included functional tasks such as stacking cones and cups, positioning the cup upright, throw a ball into basket, carrying a wooden block and buttoning and unbuttoning of shirt with counting. Each task was performed for 10 minutes and had a rest break of 1 minute.
15885387|NCT03762967|Biological|Lipoaspiration and SVF introduction.|Lipoaspiration, isolation of SVF and introduction into testis Interstitium.
15885388|NCT03762967|Drug|Standard therapy.|Standard therapy include to give up bad habits, to establish a healthy diet, to eliminate excessive physical exertion. eliminate. In the case of endocrine disorders, hormone therapy is prescribed.
15885389|NCT03762954|Other|Neurocognitive function assessment|Neurocognitive function will be assessed via a phone battery derived from standard cognitive tests proven feasible and valid to assess memory, attention, reasoning, and executive functioning. Functional status will also be assessed via phone. The duration of time required for the patient to complete telephone interview for neurocognitive and functional assessment will be approximately 45 minutes per time point.
15885390|NCT03762928|Drug|PF-06651600|200 milligram (mg) PF-06651600 once daily (QD) orally for 11 days
15885391|NCT03762928|Drug|midazolam|single administration of midazolam 2 mg oral solution
15885392|NCT03762928|Drug|efavirenz|single administration of efavirenz 50 mg capsule
15885393|NCT03762915|Drug|minocycline HCl microspheres|Minocycline HCl microspheres, 1 mg are approved by the Food and Drug Administration (FDA) as an adjunct to SRP procedures for reduction of pocket depth in patients with adult periodontitis.
15885394|NCT03762889|Device|Eyeprotx™ General Anesthesia Protective Goggles|Eyeprotx™ Protective Goggles have been designed specifically for use in the operating room or in any scenario where general anesthesia must be used, such as intubation in an emergency. The integral function is to reduce intraocular pressure while in place, prevent operating room bright light penetration, facilitate a swift placement preventative measure with straps, form a barrier against bacterial invasion and mechanical damage. This study would seek to examine this goggles' effectiveness as a preventative measure as vs. other measures.
15885395|NCT03762889|Device|Eyelid Tape|Taping the eyelids during intubation is one of the standard techniques used perioperatively under general anesthesia. This intervention would be used for the Eyelid Tape Group.
15885396|NCT03762889|Device|Eye Ointment|Another standard technique used perioperatively under general anesthesia is to apply an ointment to the eye for lubrication. This intervention would be applied to the Eye Ointment Group.
15885397|NCT03762863|Device|Tourniquet application skill retention|Tourniquet application following the procedure as learned in the Stop the Bleed curriculum.
15885398|NCT03762850|Drug|sparsentan|Target dose of 400 mg daily
15885399|NCT03762850|Drug|irbesartan|Target dose of 300 mg daily
15885400|NCT03762837|Other|Benigh gallbladder diseases|We aim to observe the relationship between the benigh gallbladder diseases and gallbladder cancer, and we will not take any actions to interrupt.
15885401|NCT03762824|Biological|13-valent pneumococcal conjugate vaccine|Pneumococcal conjugate vaccination during antirheumatic treatment
15885402|NCT03762824|Biological|23-valent pneumococcal polysaccharide vaccine|Pneumococcal polysaccharide vaccination during antirheumatic treatment
15885403|NCT03762811|Device|NanoFUSE® Bioactive Matrix|NanoFUSE® is placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure.
15885404|NCT03762798|Device|The Bridge|The Bridge (Also known as NSS-2) is a percutaneous, auricular field stimulator developed to alleviate pain through stimulation of peripheral cranial neurovascular bundles in the external ear that could potentially gain access to brain areas involved in fear, pain and nociception. After five days, the subject will return to the clinic for device removal and disposal.
15885405|NCT03762785|Drug|nebulized Dexmedetomidine|inhalation of dexmedetomidine by nebulizer. the study drug will be prepared in 3 ml of 0.9% saline and will be administered by standard hospital jet nebulizer via face-mask with continuous flow of 100%oxygen at 6 l/m for 10 to 15 min
15885406|NCT03762772|Drug|TAF/EVG Vaginal Insert|1 combination vaginal insert (20mg TAF/16mg EVG)
15885407|NCT03762759|Procedure|Computed Tomography|Undergo PET/CT
15885408|NCT03762759|Drug|Fluciclovine F18|Given IV
15885409|NCT03762759|Radiation|Gallium Ga68-labeled PSMA-11|Given IV
15885410|NCT03762759|Procedure|Positron Emission Tomography|Undergo PET/CT
15885469|NCT03762252|Other|Dry needling|A solid filiform needle will be inserted over active trigger points in the scalene muscles for 30 seconds. The aim will be to elicit local twitch responses or the referred pain pattern of the scalene muscles.
15885650|NCT03760822|Drug|Paclitaxel|IV paclitaxel at 80 mg/m² on D1, D8 and D15
15885411|NCT03762746|Device|Transcranial Magnetic Stimulation|A custom TMS stimulator (MagStim) is used to generate repetitive biphasic magnetic pulses. Magnetic pulses are delivered with a figure-8-coil (Magnetic Coil Transducer). During the experiment, rTMS pulse intensity is adjusted to 90% of the motor threshold. Patients will be randomly assigned to receive a 1 Hz. The target area is stimulated for 10 consecutive days. Stimulation at 1 Hz was applied once a day for 10-days
15885412|NCT03762746|Drug|Control|The control group is receiving treatment as usual. EEG recording and psychopathological ratings are performed one day before the start and on the last day of the study
15885413|NCT03762720|Device|Physium treatment|patients will receive five sessions of physium therapy at 80 millibars in 30 minutes for one month in muscle injury and diagnosed by ultrasound and Shear Wave Elastography.
15885414|NCT03762694|Device|Acupuncture|Electroacupuncture (EA) and Auricular Acupuncture (AA)
15885415|NCT03762681|Drug|RO7239958|Solution for injection, subcutaneous use (SC).
15885416|NCT03762681|Other|Placebo|Sodium chloride solution for injection, SC
15885417|NCT03762668|Device|Modified delefilcon A contact lenses|Spherical soft daily disposable contact lens
15885418|NCT03762668|Device|Delefilcon A contact lenses|Spherical soft daily disposable contact lens
15885419|NCT03762655|Device|Neuro-Spinal Scaffold|"The investigational product (Neuro-Spinal ScaffoldTM or Scaffold) is a porous bioresorbable polymer scaffold comprised of a synthetic biomaterial, poly(lactic-co-glycolic acid)-b-poly(L-lysine) (PLGA-PLL). The Scaffold is cylindrical in shape (3 mm diameter) and is available is three lengths (6 mm, 8 mm, 10 mm) for optimal fit in the intraspinal lesion cavity.
~Based upon pre-clinical testing, the Scaffold is expected to be resorbed from the site of implant within 4 to 8 weeks."
15885420|NCT03762642|Procedure|Mastectomy|Removal of the whole breast
15885421|NCT03762642|Procedure|Breast-Conserving Surgery|Removal of the cancerous tissue only
15885422|NCT03762629|Behavioral|Exercise|Subjects were provided with energy-restricted diets of 1300-2200 kcal/day based on weight. The energy percentages provided by protein, fat and carbohydrate were 20%, 20% and 60%, respectively, while energy distributions at breakfast, lunch and dinner were 30%, 40% and 30%, respectively. Subjects performed a series of endurance exercise such as bicycling, walking, running, dancing and ball games for 5 hour/day, supplemented with resistance exercise. Training interventions were performed 5-6 day/week for 6 weeks. The exercise program was designed to result in an energy expenditure of 1500-2500 kcal/day.
15885423|NCT03762616|Diagnostic Test|Micro-ultrasound targeted biopsy|Micro-ultrasound targeted biopsy using the ExactVu micro-ultrasound system
15885424|NCT03762616|Diagnostic Test|mpMRI targeted biopsy|Multiparametric MRI targeted biopsy using software assisted MRI/US fusion
15885425|NCT03762603|Device|Robotic exoskeleton device|It is a non invasive and non significant risk medical device which wraps around operated knee to support motion.
15885426|NCT03762590|Other|Doxy.me genetic education +/- Color Genomics genetic education|"Doxy.me is a HIPAA compliant telemedicine platform that allows clinicians to provide education to remote patients.
~Genetic education via Doxy.me will consist of a pre-recorded genetic education video and a live interactive video conferencing session with a GENERATE genetic counselor.
~Genetic education via Color Genomics will consist of both written information and an educational video on the Color Genomics website."
15885427|NCT03762590|Other|Color Genomics genetic education|Genetic education via Color Genomics will consist of both written information and an educational video on the Color Genomics website.
15885428|NCT03762577|Other|Ground-based walking training|Patients will attend a 2-day 30-minute ground-based walking training under the supervision of a physiotherapist. Patients will walk for 1-2 days in a week without supervision. According to the Modified Borg Scale, the dyspnea intensity will be 3-4 (medium to slightly difficult) and the heart rate will be completed to not exceed 120 min / pulse. Heart rate of patients will be followed by finger type pulse oximeter
15885429|NCT03762564|Drug|Ramucirumab|Ramucirumab 8 mg/kg i.v. infusion on day 1 and 15
15885430|NCT03762564|Drug|Paclitaxel|Paclitaxel 80 mg/m2 on day 1, 8, 15
15885431|NCT03762551|Other|skin biopsy|Two (4 mm) punch skin biopsies were taken from the 20 patients; one prior to the initiation of phototherapy and the other after the last session (from the same site). One skin biopsy was taken from the skin of each of the 10 control healthy participants. Skin biopsy specimens were preserved in Radio-Immunoprecipitation Assay (RIBA) buffer.
15885432|NCT03762538|Drug|Propofol|Patients will be induced to unconsciousness using propofol intravenously.
15885433|NCT03762525|Radiation|ECG gated CTA|"Routine care consists of a preoperative and several postoperative CTA scans. In A. The preoperative and first postoperative CTA will be replaced by ECG-gated CTA imaging and in B. the scheduled imaging will be replaced by an ECG-gated CTA.
~General information: The protocol is based on the ECG gated cardiac protocol using abdominal parameter settings."
15885434|NCT03762499|Diagnostic Test|Echocardiography scan|Non-invasive ultrasound imaging of the heart.
15885435|NCT03762486|Other|TENS|4 electrodes were placed 2-3 cm lateral to the incision of the patients at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery and electrical stimulation was implemented at varying frequencies of 2-100 Hz for 30 minutes, at a maximum current intensity of 12 milliamperes that would not bother the patient or create muscle contractions, with a pulse duration of 0.25 min
15885436|NCT03762486|Other|TAES|4 electrodes were placed at the ST25, P6, ST36, and LI4 acupuncture points of the patients at the 30th minute and 2, 18, 22, 42, and 46th hours after the surgery and electrical stimulation was implemented at varying frequencies of 2-100 Hz for 30 minutes, at a maximum current intensity of 12 milliamperes that would not bother the patient or create muscle contractions, with a pulse duration of 0.25 min
15885437|NCT03762473|Drug|Study Group|Patients will convert from current tacrolimus dose to an Envarsus dose that is 80% of the total tacrolimus dose. They will take envarsus once daily in the morning and have 24 hour trough levels monitored at the standard of care interval for tacrolimus. Dosing will be titrated to achieve goal levels.
15885438|NCT03762473|Drug|Control Group|Post transplant patients (kidney transplant alone) performed between 10-2016 and time of enrollment with standard of care immunosuppression, no prior rejection, prior BK or opportunistic infection, whom had a negative BK screening at month 1 and concentration/dose of < 1 at month 1, and BK data available and month 2,3, 6,9,12.
15885439|NCT03762460|Other|Online eHealth tool|Mobile-optimized online eHealth tool to support MBC.
15885578|NCT03761394|Device|Cardea Solo by Cardiac Insight|Gold-standard cardiac monitor for comparison of testing devices.
15885442|NCT03762434|Other|mobile application|"Mobile app: The participants can view the Life style modification program by using the app. In addition, a membership area of the app provides individual support of self- health monitoring, goal setting of exercise plan and exercise record. A user guide of the MetS app will be provided to the participants to take home after the briefing.
~Booklet : The booklet content covers 26 pages about the metabolic syndrome and risk factors, suggested life style modification tips in terms of exercise, diet, smoking, mediation and stress management."
15885443|NCT03762421|Behavioral|Psycho-social skills development workshops based on PM plus|5 weekly, psycho-social skills development workshops will be conducted for newly inducted civil servants in groups, based on the problem management plus intervention. These workshops will be integrated into routine induction sessions of trainee civil servants. Workshop 1 orients participants to the intervention with motivational interviewing techniques to improve engagement, teaches the difference between technical and adaptive challenges, and trains participants in a basic stress management strategy. Workshop 2 addresses a participant-selected problem using problem-solving techniques and introduces behavioral activation. Workshops 3 and 4 support participants' continued application of problem solving, behavioral activation, and stress management and introduce strategies to strengthen social support networks whenever required. In Workshop 5, education about retaining intervention gains are provided and all learned strategies are reviewed.
15885444|NCT03762421|Behavioral|Routine training induction sessions|The control group will receive 5 routine training induction sessions. These orientation sessions include lectures introduction to governance, public sector management, basic information technology, economics and public finance and official rules of procedure of the government of Pakistan. These lectures are held in a friendly and supportive environment.
15885445|NCT03762408|Device|ENKO 1|50 mg of HA/ 50 mg of CS in 5 ml
15885446|NCT03762408|Device|Durolane|60 mg HA crosslinked in 3 ml
15885447|NCT03762395|Drug|CXA-10|6 weeks of treatment with 150 mg/day of orally administered CXA-10
15885448|NCT03762395|Drug|Matching Placebo|6 weeks of treatment with orally administered matching placebo (to 150 mg/day of CXA-10)
15885449|NCT03762382|Drug|TFV/LNG IVR|TFV/LNG IVR is an intravaginal ring that releases approximately 8-10 mg/day of TFV and approximately 20ug/day of LNG to be used for 90 continuous days.
15885450|NCT03762382|Drug|TFV IVR|TFV IVR is an intravaginal ring that releases approximately 8-10mg/day of TFV to be used for 90 continuous days.
15885451|NCT03762382|Drug|Placebo IVR|Placebo IVR is an intravaginal ring containing no active experimental ingredients to be used for 90 continuous days.
15885452|NCT03762369|Drug|CKD-351|twice a day
15885453|NCT03762369|Drug|Latanoprost|once a day
15885454|NCT03762369|Drug|D930|three times a day
15885455|NCT03762369|Drug|Placebo of CKD-351|once a day
15885456|NCT03762369|Drug|Placebo of CKD-351|twice a day
15885457|NCT03762369|Drug|Placebo of D930|three times a day
15885458|NCT03762343|Drug|ultrasound guided Greater occipital nerve block|ultrasound guided Greater occipital nerve block with 2 ml of bupivacaine 0.5% (up to a maximum of 2 mg/kg) subcutaneous under ultrasound guidance in the greater occipital nerve region bilaterally.
15885459|NCT03762343|Drug|control group C|Patient in this group will receive the intraoperative standard of care(intraoperative intravenous fentanyl and paracetamol)
15885460|NCT03762330|Behavioral|COPD structured self-management plan.|Education plan , including knowledge of the disease, healthy life habits, correct use of inhalers, skills to control symptoms and strategies to face the disease and exacerbations
15885461|NCT03762317|Drug|Clonidine|clonidine will be given at 12 mcg/kg/d to the experimental arm in addition to oral morphine
15885462|NCT03762317|Drug|Placebo|Placebo with volume similar to clonidine at 12 mcg/kg/d will be given to this arm in addition to oral morphine
15885463|NCT03762304|Other|Household blood pressure screening with care encouragement|"During the household survey visit, survey enumerators collected two measurements of the respondent's blood pressure. If either of the measurements exceeded 140 mmHg systolic or 90 mmHg diastolic, enumerators told participants: Your blood pressure readings are higher than normal. High blood pressure is dangerous because it makes the heart work too hard. High blood pressure increases the risk of heart disease and stroke. High blood pressure can also cause other problems, such as heart failure, kidney disease, and blindness. You can control high blood pressure by taking action. Then the enumerators recommend that an individual seek medical care within 2 months."
15885465|NCT03762278|Dietary Supplement|Leucine|Participants will ingest 15g of leucine supplementation/day during the immobilisation period. Leucine supplementation will be administered in powdered form (Infinit Nutrition, Canada) and participants will be required to consume 5g of leucine mixed with 250-300 ml of water during each meal. Leucine is a dietary supplement according to the US FDA. This supplementation protocol has been demonstrated in humans (Murphy et al., 2016, AJCN) with no reported side effects. The quantity of leucine supplementation falls well within the safe limits outlined by Rasmussen et al. (2016). Infinit Nutrition Leucine is in compliance with banned substances requirements as espoused by the World Anti-Doping Agency. Infinit Nutrition Leucine is not a medicinal product.
15885466|NCT03762278|Dietary Supplement|Placebo|"Participants will ingest 15g of placebo supplementation/day during the immobilisation period. Placebo supplementation will be administered in powdered form and participants will be required to consume 5g of placebo supplementation mixed with 250-300 ml of water during each meal (3x/day).
~Placebo supplementation will contain 5g of non-essential amino acids (Infinit Nutrition, Canada) and will be calorically matched to the leucine supplementation.This supplementation protocol has been demonstrated previously in humans, with no reported side effects (Murphy et al., 2016, AJCN)."
15885467|NCT03762265|Drug|Rilzabrutinib Oral Tablet|Bruton's tyrosine kinase (BTK) inhibitor
15885468|NCT03762265|Drug|Placebo Oral Tablet|Placebo
15885470|NCT03762252|Other|Manual Therapy|The therapist will apply manual compression over active trigger points in the scalene muscles for 30 seconds
15885472|NCT03762239|Other|Using a sham air purifier (same device without filters)|Use the air purifier (Pure Airbox, Zonair 3D) without filters in the classroom where the experiment is conducted
15885473|NCT03762226|Drug|Anti-VEGF|Patients will undergo as part of the routine care 4 monthly anti-VEGF injections.
15885474|NCT03762213|Device|Oculus GO VR HMD, application Happy Place (© Mimerse)|The Entertainment Software Rating Board (ESRB) has rated Happy Place as 'E' ('Everyone' or content suitable for all ages).
15885475|NCT03762213|Device|iPad, application Happy Place (© Mimerse)|The Entertainment Software Rating Board (ESRB) has rated Happy Place as 'E' ('Everyone' or content suitable for all ages).
15885476|NCT03762200|Device|SURGICEL Powder|SURGICEL Powder is a topical absorbable hemostatic treatment made of oxidized regenerated cellulose (ORC) - plant material
15885477|NCT03762187|Behavioral|Self-affirmation|Individuals select important values and then write about why that value is important to them.
15885478|NCT03762187|Behavioral|Positive living counseling|Each of the clinics from which participants were recruited conducts positive living counseling as part of their treatment programs. This counseling is conducted by counselors who are trained and monitored by the Lesotho Network of AIDS Support Organizations (LENASO) and consistent with the positive prevention framework (see Bunnell et al., 2005 for description). Each counseling session focused on addressing positive living goals such as the importance of taking one's medications on time and every day, using protection with every partner, and the importance of maintaining a healthy lifestyle.
15885479|NCT03762161|Drug|TAS 102|Participant self-administered orally at 35 milligrams per meter squared (mg/m2) twice daily Days 1-5 and 8-12 of every 28 day cycle
15885480|NCT03762148|Dietary Supplement|ferrous fumarate|nutritional iron (14 mg) supplement in form of ferrous fumarate
15885481|NCT03762148|Dietary Supplement|ferrous sulphate|nutritional iron (14 mg) supplement in form of ferrous sulphate
15885482|NCT03762148|Dietary Supplement|ferric pyrophosphate|nutritional iron (14 mg) supplement in form of ferric pyrophosphate
15885483|NCT03762148|Dietary Supplement|ferrous fumarate + 3.5 g GOS|nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (3.5 g GOS)
15885484|NCT03762148|Dietary Supplement|ferrous fumarate + 7 g GOS|nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (7 g GOS)
15885485|NCT03762148|Dietary Supplement|ferrous sulphate + 15 g GOS|nutritional iron (14 mg) supplement in form of ferrous sulphate with addition of prebiotics (15 g GOS)
15885486|NCT03762148|Dietary Supplement|ferrous fumarate + Vitamin C|nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of Vitamin C
15885487|NCT03762148|Dietary Supplement|ferric pyrophosphate + 15 g GOS|nutritional iron (14 mg) supplement in form of ferric pyrophosphate with addition of prebiotics (15 g GOS)
15885488|NCT03762148|Dietary Supplement|ferrous fumarate + 7 g GOS + Vitamin C|nutritional iron (14 mg) supplement in form of ferrous fumarate with addition of prebiotics (7 g GOS) and Vitamin C
15885489|NCT03762135|Other|Full version of the LIITah App.|Participants will download the LIITAH app. For the first 2 weeks the app. will only record presence in a restaurant and ask users to submit photos of their food. in week 3 all of the program features will be activated.
15885490|NCT03762135|Other|Partial App. (ELI and SNAP only)|Participants will download the LIITAH app. It will detect their presence in a restaurant and users will submit annotated photos of their purchases
15885491|NCT03762122|Drug|Rogaratinib|Rogaratinib (BAY 1163877; Bayer) is an oral pan-kinase inhibitor, which selectively inhibits FGFR1, FGFR2, FGFR3, and FGFR4.
15885492|NCT03762109|Drug|Dantrolene|muscle relaxant
15885493|NCT03762109|Drug|Placebo Oral Tablet|inactive pill
15885494|NCT03762096|Dietary Supplement|Trans-resveratrol|1 gram, twice a day by mouth Transmax (Biotivia)
15885495|NCT03762096|Dietary Supplement|Placebo|Placebo
15885496|NCT03762083|Device|pHyph, Gedea pessary|pHyph is a vaginal tablet for the treatment of BV.
15885497|NCT03762070|Device|CL Detect™ Rapid Test|Observational study of a FDA cleared device, the CL Detect™ Rapid Test.
15885498|NCT03762057|Diagnostic Test|Intraabdominal pressure monitoring|Classic manometry technique measurement once daily
15885499|NCT03762044|Other|Activity-oriented Proprioceptive Antiedema Therapy (TAPA)|"Health education / patient empowerment.
~Neurodynamic activities oriented to ADL.
~Proprioceptive neuromuscular facilitation exercises oriented to ADL.
~Self-adherent self-adhesive antiedema of low compression."
15885500|NCT03762044|Other|Complete Decongestive Therapy (CDT)|"Skin care.
~Kinesitherapy
~Manual lymphatic drainage (MLD)
~Multilayer bandage.
~The maintenance phase is based on self-care and the use of compression garments."
15885501|NCT03762031|Drug|GC4711 30mg|single dose given via a 15 minute intravenous infusion
15885502|NCT03762031|Drug|GC4711 60mg|single dose given via a 15 minute intravenous infusion
15885503|NCT03762031|Drug|GC4711 90mg|single dose given via a 15 minute intravenous infusion
15885504|NCT03762031|Drug|GC4711 120mg|single dose given via a 15 minute intravenous infusion
15885505|NCT03762031|Drug|Placebo|single dose of normal saline given via a 15 minute intravenous infusion
15885506|NCT03762031|Drug|GC4711 75mg|single dose given via a 15 minute intravenous infusion
15885507|NCT03762031|Drug|GC4711 105mg|single dose given via a 15 minute intravenous infusion
15885508|NCT03762018|Drug|Carboplatin|Carboplatin belongs to the group of medicines known as alkylating agents. Carboplatin interferes with the growth of cancer cells, which eventually are destroyed.
15885509|NCT03762018|Drug|Pemetrexed|Pemetrexed is a type of drug known as an anti metabolite. It stops cells making and repairing DNA so they can't grow and multiply.
15885510|NCT03762018|Drug|Bevacizumab|Bevacizumab is an angiogenesis inhibitor. It works by targeting a protein called vascular endothelial growth factor (VEGF) that helps cancers form new blood vessels. By stopping this process, bevacizumab 'suffocates' the blood supply to the cancer, shrinking it and stopping it from growing.
15885511|NCT03762018|Drug|Atezolizumab|Atezolizumab is in a class of medications called monoclonal antibodies. It works by blocking the action of a certain protein in cancer cells. This helps the immune system to fight against the cancer cells, and helps to slow tumor growth.
15885512|NCT03762005|Other|CRT guided resuscitation|Sequential approach with fluids (guided by dynamic predictors of fluid responsiveness), according to capillary refill time (CRT)
15887295|NCT03748706|Drug|PTI-125, 100 mg tablets|PTI-125, 100 mg tablets taken twice a day for 28 days
15885513|NCT03762005|Other|Lactate guided resuscitation|Sequential approach with fluids (guided by dynamic predictors of fluid responsiveness), according to lactate levels
15885514|NCT03761992|Dietary Supplement|Gingko Baloba|Tablets
15885515|NCT03761992|Other|Placebo|Tablets
15885516|NCT03761979|Dietary Supplement|Strontium L-lactate|The Study Product was a highly pure form of SrLac, the strontium salt of L-lactic acid. SrLac was manufactured in compliance with current Good Manufacturing Practices. SrLac was thoroughly tested and met rigorous purity specifications. It was free from contamination by D-lactic acid and trace metals known to harm human health.
15885517|NCT03761966|Other|Pregnant women|
15885518|NCT03761953|Drug|Oritavancin Injection|single 1200mg infusion of IV oritavancin.
15885519|NCT03761940|Other|EQ5D questionnaire and a demographic questionnaire|questionnaires
15885520|NCT03761927|Device|Hearing Aid without NR enabled|Each participant will be fitted with noise reduction disabled. Disabled means that no sound processing algorithm that removes noise from the speech signal is active.
15885521|NCT03761927|Device|Hearing Aid with NR(1)|Each participant will be fitted with the noise reduction program on the same hearing aid. The principle of the noise reduction algorithm is to remove noise from a speech signal with the aim of improving the speech intelligibility and comfort.
15885522|NCT03761927|Device|Hearing Aid with NR(2)|Each participant will be fitted with a second noise reduction program on the same hearing aid. The parameterization of this NR algorithm differs from that in NR(1).
15885523|NCT03761914|Biological|galinpepimut-S|Galinpepimut-S will be administered as monotherapy, then galinpepimut-S will be co-administered with pembrolizumab. After that, there will be un-paired administration of pembrolizumab and galinpepimut-S according to the schedule described in the protocol and described in the arm/group descriptions on ClinicalTrials.gov.
15885524|NCT03761914|Drug|Pembrolizumab|Galinpepimut-S will be administered as monotherapy, then galinpepimut-S will be co-administered with pembrolizumab. After that, there will be un-paired administration of pembrolizumab and galinpepimut-S according to the schedule described in the protocol and described in the arm/group descriptions on ClinicalTrials.gov.
15885525|NCT03761901|Drug|1L treatment|chemotherapy, EGFR TKI, immunotherapy, other
15885526|NCT03761901|Drug|2L Treatment|Chemotherapy, EGFR TKI, immunotherapy, other
15885527|NCT03761901|Drug|3L treatment|chemotherapy, EGFR TKI, immunotherapy, other
15885528|NCT03761888|Diagnostic Test|optic nerve sheath measurement and transcranial doppler|evaluation of cerebral hemodynamics through measurement of systolic and diastolic velocities and PI in middle cerebral artery. Intracranial pressure will be appreciate by optic nerve sheath value
15885529|NCT03761875|Other|blood sample CHB patients|"During a boold sample at only one follow up visit:
~3 tubes EDTA 10 ml per patient
~1 tube Paxgene 1ml
~1 dry tube per patient"
15885530|NCT03761875|Other|boold sample Control group|"2 tubes EDTA ideally age and sex matched to CHB patient.
~1 tube Paxgene 1ml
~1 dry tube"
15885531|NCT03761862|Procedure|Neural Therapy|Neural therapy is a form of alternative medicine in which local anesthetic is injected into certain locations of the body in an attempt to treat chronic pain and illness.
15885534|NCT03761836|Device|ShangRing|The ShangRing™ is a device for male circumcision that was invented by Jian Zhong Shang and has been on the Chinese market since 2005. It consists of a sterile device with two concentric medical grade plastic rings: an inner ring with a silicone band and an outer, hinged ring. The inner ring fits inside the outer ring which will lock when snapped together. It currently holds a European Conformity (CE) mark, an EN ISO certificate, and is FDA approved. Clinical data from ShangRing studies in Africa were reviewed by the WHO Technical Advisory Group (TAG) on Innovations in Male Circumcision in January 2013 and were found to meet its clinical requirements. The ShangRing manufacturer was accepted by the WHO Prequalification Programme for Male Circumcision Devices in 2015.
15885535|NCT03761810|Drug|S6G5T-3|once a day topical cream
15885536|NCT03761810|Drug|S6G5T-8|once a day topical cream
15885537|NCT03761797|Drug|TRADIANCE® Combination Tablets AP|Fixed dose combination
15885538|NCT03761797|Drug|TRADIANCE® Combination Tablets BP|Fixed dose combination
15885539|NCT03761784|Drug|S6G5T-3|once a day topical cream
15885540|NCT03761784|Drug|S6G5T-8|once a day topical cream
15885541|NCT03761771|Device|colonoscopy withdrawal with the ADS monitoring|During the testing of trained ADS, when the system doubts colonic lesions from the input data of the test images, a rectangular frame was displayed in the endoscopic image to surround the lesion. If the system confirmed it as the colonic lesions, a sound of reminder will be played and the types of lesions (non-adenomatous polyps, adenomatous polyps and colorectal cancers) will be classified by the system. We adopted several standards to define the identification and classification of colonic lesions: 1) when the system identified and confirmed any lesion in the images of no polyps or cancers, the results were judged to be false-positive. 2) when the system both confirmed and correctly localized the lesions in images (IoU > 0.3), the results were judged to be true-positive. 3) when the system did not confirm or correctly localize the lesions, the results were judged as false-negative. 4) when system confirmed no lesions in the normal images, the results were judged to be true-negative.
15885542|NCT03761758|Device|Spectacle lenses|Spectacle lenses with clear central apertures
15885543|NCT03761732|Behavioral|Islamic Trauma Healing|6 session behavioral intervention program designed to reduce PTSD and related symptomatology
15885544|NCT03761719|Other|No intervention|No intervention
15885545|NCT03761706|Behavioral|Engagement in Physical Activity|Study participants will be asked to wear a FitBit provided by the research team and agree to FitBit data downloads during regularly scheduled chemotherapy clinic visits. Participants will also complete a daily exercise log to record the total number of minutes walked and the total number of steps from the FitBit.
15885546|NCT03761706|Other|Questionnaires|Study participants will complete the following questionnaires: Health Behavior Questionnaire (HBQ), Short Physical Performance Battery (SPPB), Functional Assessment of Cancer Therapy-General (FACT-G), 4.4.5 Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), PROMIS Cognitive Function (Short Form 8a), Functional Assessment of Cancer-Gynecology Oncology Group-Neurotoxicity (FACT/GOG-NTX-12) Version 4, Nutrition Survey, Perceived Self-Efficacy for Fatigue Self-Management (PSEFSM),
15889014|NCT03735303|Dietary Supplement|VD3 group|VD3 50000 IU/ week for 8 weeks
15885547|NCT03761693|Other|Fasting test|"The included infants will be fasted according to local standardized procedures at the University Medical Centre Groningen. Fasting will take place under hourly blood glucose monitoring and bedside supervision by an experienced, dedicated pediatric nurse, in collaboration with a metabolic pediatrician, who will be available to attend the patient instantly. Furthermore, on request of parent(s) or guardian(s), a continuous blood glucose monitoring device can be used during the study visits.
~During study visit 1, at two months of life, fasting will be continued for maximally eight hours.
~During study visit 2, at six months of life, fasting will be continued for maximally twelve hours.
~Fasting will be ended prematurely in the following events:
~blood glucose concentration drops < 3.6 mmol/L;
~the child shows symptoms/signs of a low blood glucose concentration;
~patients parent(s) or guardian(s) request end of fast."
15885548|NCT03761680|Dietary Supplement|MEDPass mode of administration|Allocation of 50 ml of ONS four times per day distributed with the medication rounds
15885549|NCT03761680|Dietary Supplement|Control Intervention|Patients receive ONS between meals or at their request as usual
15885550|NCT03761667|Other|Endoscopy using Narrow band imaging|Inspection of resection margin of SSA/P for the evaluation of complete resection or the presence of remnant lesion using NBI method
15885551|NCT03761654|Diagnostic Test|Global Longitudinal Strain measure|Global Longitudinal Strain measure on day 1 of hospitalization
15885552|NCT03761641|Other|Neurotriage|NeuroTriage binocular handset monitors pupil dynamics & eye position with infrared cameras. Rubber non-allergenic ocular spacers contoured to eye sockets come in contact with the face &cushion between the skin & eyepiece. During pupil dilation tests, an LED briefly illuminates the pupil. The NeuroTriage system measures neurological pupil index, constriction velocity, & dilation velocity. Total pupil dilation testing time is < 1 minute. During saccade-tracking tests, patients direct their gaze towards dim LED targets selectable across the range of view. Visual targets involve center-out ocular motion or smooth pursuit following of illusory movement. The NeuroTriage system measures eye position & movement velocity during these tests. Total saccade-tracking testing takes < 3 minutes. Ocular measures are non-invasive, are done quickly and commonly used to measure neurological function.
15885553|NCT03761628|Device|pHyph, Gedea pessary|pHyph is a vaginal tablet for the treatment of VVC
15885554|NCT03761615|Device|Dexcom G6 CGM|All women in the study will be given Dexcom G6 CGM and a study glucometer.
15885555|NCT03761602|Other|Not applicable (for observational studies)|This study is an observational study. No intervention will be administered for research purposes.
15885556|NCT03761589|Behavioral|AFL Intervention|The AFL intervention consisted of two 90-minute sessions per week for 12 months for both children and parents. The child physical activity sessions, held separately from the parent sessions, aimed to achieve 60 minutes of moderate-to-vigorous physical activity during each session through structured play activities, athletic drills, and sport exercises. Child dietary behaviors were taught through educational activities in small groups. For the parent program, behavior modification techniques were used to guide parents toward changing their own and their child's behavior. Take-home materials for self-monitoring of behaviors were used for both the child and the parent in order to reinforce concepts discussed in class.
15885557|NCT03761589|Behavioral|Wait-List Control|Families that were randomly assigned to the wait-list control group were asked not to change their normal physical activity or dietary behaviors for the duration of the 12-week waiting period. They were asked to participate in the baseline and 12-week evaluations and then they were enrolled to receive the 12-week intervention.
15885558|NCT03761563|Device|Fortilink IBF System with TETRAfuse Technology|Cervical and lumbar fusion
15885559|NCT03761550|Combination Product|pMDT(Process Implementation)|The pMDT(Baseline Investigation) takes multi-model analgesia as the main technical means. Multimodal perioperative analgesia refers to the combination of analgesics, adjuvant drugs and analgesic techniques with different effects throughout the perioperative period to achieve the best curative effect of reducing postoperative acute and chronic pain.
15885562|NCT03761524|Procedure|Customized V plate fixation|(CT) scan is taken for the patients and a customized V pattern plate will be designed .Intraoral approach will be done to expose the angle fracture.Fracture site will be exposed and reduced in normal anatomic position guided by the CAD/CAM plate. MMF will be done.Fracture fragments will be fixed using CAD/CAM plate .
15885563|NCT03761524|Procedure|Conventional miniplates fixation|Intraoral approach will be done to expose the angle fracture.Fracture site will be exposed and reduced in normal anatomic position. MMF will be done.Fracture fragments will be fixed using conventional miniplates fixation of angle fracture.
15885564|NCT03761511|Drug|Nicotinamide|Nicotinamide 4 g (capsules) or highest tolerated dose with a minimum of 2 g/d per os once daily
15885565|NCT03761511|Drug|Placebo|Matching Placebo (capsules) once daily
15885566|NCT03761498|Other|Caloric Requirement|Infants will be provided standard of care and given calories required to maintain appropriate growth per unit policies already in place.
15885567|NCT03761485|Other|Use of Dentifrice Fluoride|Use of few of dentifrice on brushing during a year
15885568|NCT03761472|Biological|Hyaluronic acid injection|Hyaluronic acid 48 mg 2.0% in 2.4 ml solution
15885569|NCT03761472|Biological|Platelet-rich plasma injection|Platelet-rich plasma injection 5ml
15885570|NCT03761446|Behavioral|Bed rest|The participant will remain in bed rest for 10 complete days.
15885571|NCT03761433|Device|SPI group|All patients applied surgical pleth index at the time of surgical incision, under End tidal Sevoflurane 3%
15885572|NCT03761407|Drug|100 mg GRT0151Y|100 mg capsule (1 x 100 mg capsule)
15885573|NCT03761407|Drug|125 mg GRT0151Y|125 mg (1 x 100 mg capsule and 1 x 25 mg capsule)
15885574|NCT03761407|Drug|150 mg GRT0151Y|150 mg (1 x 100 mg capsule and 1 x 50 mg capsule)
15885575|NCT03761407|Drug|225 mg GRT0151Y|Day 1: 150 mg (1 x 100 mg capsule and 1 x 50 mg capsule) Day 2 - 5: 225 mg (2 x 100 mg capsules and 1 x 25 mg capsule)
15885576|NCT03761407|Drug|Matching placebo|Matching placebo capsules using the same dosing regimen as defined in the treatment groups.
15885577|NCT03761394|Device|Testing Devices|Pulsewatch system testing application on smartphone with smartwatch.
15885580|NCT03761381|Device|Optical Coherence Tomography Angiography (OCTA) Imaging|Optical coherence tomography is a non-invasive imaging technology that provides cross-sectional images of tissues in micron-scale resolution. The angiography component of this device allows for evaluation of blood vessel and blood flow changes in the eye. The RTVue-XR device with AngioVue software will be used to detect these blood vessel and flow changes as well as protein deposits in the retinal layers. Subjects will take oral curcumin supplements to hyperfluoresce and improve detection of the amyloid proteins within the retinal layers.
15885581|NCT03761381|Device|Noninvasive Retinal Amyloid Imaging (NRAI)|The Spectralis will be used for NRAI. This system uses a special light source and optical filters to detect fluorescence of amyloid proteins in the eye.Subjects will take oral curcumin supplements to hyperfluoresce and improve detection of the amyloid proteins within the retinal layers.
15885582|NCT03761368|Procedure|Remote Ischemic Preconditioning|four cycles of 5-min inflation to 200 mmHg followed by 5-min deflation of left upper - arm cuff
15885583|NCT03761368|Procedure|Sham Remote Ischemic Preconditioning|deflated cuff placed on the left arm for 40 min
15885584|NCT03761342|Behavioral|Multiple Traffic Light Label|The United Kingdom's Multiple Traffic Light label has repeatedly demonstrated effectiveness and has been widely implemented in Europe. The label shows how much calories, fats, saturated fats, sugar and salt are present in a product, with associated traffic light signals for high (red), medium (amber) and low (green) percentages for each attribute.
15885585|NCT03761342|Behavioral|Nutri-Score Label|In late 2017, France began voluntary implementation of one FOP label, termed Nutri-Score, adapted from its predecessor, the 5-colour Nutrition Label. Consumer acceptability and understanding of the NS label has been demonstrated in several studies. It provides a letter score as a composite grade of a product's nutrition quality from A (best) to E (worst).
15885586|NCT03761329|Procedure|mini-Bier's block with lidocaine 0.5% 25ml|An intravenous catheter will be placed in the dorsal vein of the hand that will undergo surgery. Afterwards, a tourniquet will be placed on the forearm and inflated, after which the anesthetic can be administered via the dorsal vein catheter (25ml lidocaine 0.5%). The tourniquet remains inflated for 10 minutes to reduce systemic toxicity reactions postoperatively.
15885587|NCT03761329|Procedure|Conventional Bier's block with lidocaine 0.5% 40ml|An intravenous catheter will be placed in the dorsal vein of the hand that will undergo surgery. Afterwards, a tourniquet will be placed on the upper arm and inflated, after which the anesthetic can be administered via the dorsal vein catheter (40ml Lidocaine 0.5%). The tourniquet remains inflated for 25 minutes to reduce systemic toxicity reactions postoperatively.
15885588|NCT03761316|Other|interview regarding goals|interview regarding goals
15885589|NCT03761303|Device|active rTMS|The rTMS coil is applied tangentially to the head surface above the left DLPF (corresponding to position F3 of the international 10-20 system). For the stimulation intensity, the motor rest threshold of the patient is determined. The motor rest threshold is defined as the minimum intensity that triggers an EMG response with an amplitude> 50 μV in the first right interosseus dorsalis muscle in at least 5 out of 10 cases. The stimulation intensity within the rTMS therapy is 80 percent of the motor rest threshold. In one session, 1,000 pulses are applied in 10 trains at a frequency of 10 Hz (1 train = 100 pulses in 10 s). Between the individual trains there is an inter-train interval of 28 seconds. The total duration of a session is 5:52 minutes. In total, the patient recieve 20 sessions.
15885590|NCT03761303|Device|sham rTMS|Patients in the intervetion group (active rTMS stimulation) receive active 10 Hz rTMS stimulation over the left dorsolateral prefrontal cortex (DLPFC) over a period of 20 days, seven days a week (20 sessions).
15885593|NCT03761264|Drug|Odontopaste®|Teeth with abscess will be opened from the crown to allow cleaning of the canals following which the Odontopaste® will be placed in the canals and the pulp chamber. Cavity will be sealed with capsulated Glass ionomer cement.
15885594|NCT03761264|Drug|Pulpdent|Teeth with abscess will be opened from the crown to allow cleaning of the canals following which the Pulpdent paste will be placed in the canals and the pulp chamber. Cavity will be sealed with capsulated Glass ionomer cement.
15885595|NCT03761264|Drug|Amoxicillin|Teeth with abscess will be opened from the crown to allow cleaning of the canals . A sterile cotton pellet will be placed in the pulp chamber and cavity sealed with capsulated Glass ionomer cement. The patient will be prescribed oral amoxicillin at 15mg/kg body weight tds for 5 days
15885596|NCT03761251|Behavioral|Pet Fish|"Participants will be provided a fish tank with supplies to care for the fish and access to a fish (Betta splendens) from a local pet store. All participants will receive specific instructions for coupling the fish care and diabetes care:
~feed fish one pellet in the morning after waking; check and record BG reading at that time
~feed fish one pellet in the evening before dinner; check and record BG reading at that time
~feed fish one pellet at night before bedtime; check and record BG reading at that time
~every week clean the tank alternating with test the water quality in partnership with caregiver; review blood glucose readings with caregiver with each weekly fish care activity and problem solve any issues related to the blood glucose pattern.
~Each child will also receive two books intended to supplement and enrich their pet fish experience."
15885597|NCT03761238|Device|Molecular Adsorbent Recirculating System|MARS therapy will start within 24-48 h after randomization and be given on 3 consecutive days in sessions of 8-12 h. The patients are observed for 2 days following the last session, with focus on bilirubin INR and signs of encephalopathy, and can thereafter receive 3 additional sessions in case of no or partial response to treatment.
15885598|NCT03761238|Other|Standard medical treatment (SMT)|Patient management and standard medical treatment (SMT) as specified in the study protocol.
15885599|NCT03761225|Drug|Masitinib|
15885600|NCT03761225|Drug|Docetaxel|
15885601|NCT03761225|Drug|Prednisone|
15885602|NCT03761225|Drug|Placebo|
15885651|NCT03760809|Drug|Dexmedetomidine 0.5μg／kg|Group A received dexmedetomidine 0.5μg／kg (diluted to 100ml，influded in 5 mins at the beginning of the surgery) and hydromophine 0.03 mg／kg as a bolus.
15886042|NCT03757910|Drug|18F-MK-6240|This radiotracer will be used to detect Tau.The injected activity will equal 5 millicuries (mCi).
15885603|NCT03761199|Other|whole body cryostimulation|In this research project will be performed 15 treatments in cryogenic chamber (1 once a day, every day, with a break on Saturdays and Sundays). Cryostimulation will be conducted in a cryochamber located in the Małopolska Cryotherapy Centre in Kraków, Poland (Polish: Małopolskie Centrum Krioterapii). The whole body cryostimulation (WBC) exposure will be administered in a special temperature-controlled unit which consists of two rooms (-60° and -120°C). Throughout the session, the participants will be under direct supervision of qualified doctor.
15885604|NCT03761186|Behavioral|traditional diabetes diet|Diet with carbohydrate content 50-60% of total energy intake
15885605|NCT03761186|Behavioral|moderately low carbohydrate diet|Diet with carbohydrate content 30-40% of total energy intake
15885606|NCT03761186|Behavioral|strictly low carbohydrate diet|Diet with carbohydrate content 15-20% of total energy intake
15885607|NCT03761173|Device|FlowTriever System|Thrombectomy
15885608|NCT03761173|Drug|Anticoagulation Agents|Anticoagulation medication
15885609|NCT03761160|Other|Mobile Health App|mobile health app aims to provide patients who are about to initiate androgen deprivation therapy for prostate cancer with an exercise program and better eating habit
15885610|NCT03761160|Other|Usual care|Usual care per hospital guidelines
15885611|NCT03761147|Other|Paula exercises|structured exercises aimed to stimulate ring muscles
15885612|NCT03761134|Drug|sotagliflozin (SAR439954)|"Pharmaceutical form: tablet
~Route of administration: oral"
15885613|NCT03761134|Drug|placebo|"Pharmaceutical form: tablet
~Route of administration: oral"
15885614|NCT03761134|Drug|metformin|"Pharmaceutical form: tablet
~Route of administration: oral"
15885615|NCT03761134|Drug|sulfonylurea|"Pharmaceutical form: tablet
~Route of administration: oral"
15885616|NCT03761121|Other|Wave-CAIPI|"wave-CAIPI technology, a data acquisition / reconstruction scheme designed to optimally exploit available information in modern multi-channel receivers and in multi-contrast/time-series data for improved image encoding"
15885617|NCT03761108|Drug|REGN5458|Administered by intravenous (IV) infusion
15885620|NCT03761082|Other|NA(observation study)|NA(observation study)
15885622|NCT03761056|Biological|Axicabtagene Ciloleucel|A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously
15885623|NCT03761056|Drug|Fludarabine|Administered according to package insert
15885624|NCT03761056|Drug|Cyclophosphamide|Administered according to package insert
15885625|NCT03761043|Behavioral|Professional Behavior Change Intervention|IV to PO antimicrobial conversion guidelines for nurses, nurse in-services and internet education sessions, IV to PO antimicrobial conversion health record reminder, endorsement from antimicrobial stewardship program, prescribers, and nurse educators.
15885626|NCT03761030|Drug|L-DOPA|We will be using generic sinemet 25/100 tablets in this study.
15885627|NCT03761030|Drug|Placebo Oral Tablet|25/100 placebo tablets
15885628|NCT03761017|Biological|MGD019|Bispecific DART protein binding PD-1 and CTLA-4
15885629|NCT03761004|Drug|carbidopa-levodopa|single dose of WD-1603, BID dose of WD-1603 and Sinemet IR
15885630|NCT03760991|Drug|INSULIN GLARGINE (U300)|"Pharmaceutical form: Solution for injection in a prefilled pen
~Route of administration: Subcutaneous"
15885631|NCT03760978|Drug|Dexmedetomidine|
15885632|NCT03760965|Drug|sotagliflozin (SAR439954)|"Pharmaceutical form: tablet
~Route of administration: oral"
15885633|NCT03760965|Drug|placebo|"Pharmaceutical form: tablet
~Route of administration: oral"
15885634|NCT03760939|Other|Clinical and economical evaluation|Evaluation of the clinical and the economical impact of a colorectal surgery
15885635|NCT03760926|Device|AblaCare Kit|The intervention consists in the realisation of the AblaCare Procedure using the AblaCare Kit, which comprises two elements: a disposable device (AblaCare Device) and a radiofrequency (RF) energy generator (AblaCare System). The AblaCare Device is a short-term invasive device delivered and positioned through the vagina to deliver RF energy inside the ovary in order to ablate ovarian tissue.
15885636|NCT03760913|Drug|OLP-1002 (Test): Part A, Single Ascending Dose|Subcutaneous Injection: 30 ng, 120 ng, 400 ng, 1.2 µg, 3 µg, 6 µg, 12 µg, 20 µg, 40 μg, 80 μg, 160 μg
15885637|NCT03760913|Drug|OLP-1002 (Test): Part B, Multiple Ascending Dose|Subcutaneous Injection: 5 x 2 μg, 5 x 5 μg, 5 x 10 μg, 5 x 20 μg, 5 x 40 μg, 5 x 80 μg
15885638|NCT03760913|Other|Placebo: Placebo Part A, Single Ascending Dose|Subcutaneous Injection: Placebo
15885639|NCT03760913|Other|Placebo: Placebo Part B, Multiple Ascending Dose|Subcutaneous Injection: Placebo x 5
15885640|NCT03760900|Combination Product|Autologous Umbilical Cord Blood Stem Cells Therapy|Autologous Umbilical Cord Blood Stem Cells Therapy,the dose is 5×107cells/kg, within 24 hours after birth
15885641|NCT03760887|Other|Home exercise program only|After 5 minutes of sensory discrimination (using a 9 point grid) in the clinic patients will perform a home exercise program only
15885642|NCT03760887|Other|Home exercise program and home program of sensory discrimination|After 5 minutes of sensory discrimination (using a 9 point grid) in the clinic patients will perform a home exercise program and two 5 minutes sessions of sensory training at home each day.
15885643|NCT03760861|Device|Prototype Microcapsule Treatment|The subject will be sedated and using an endoscope, a prototype microcapsule will be placed into the gastric corpus. Then, an external handheld magnet will be applied to inflate the balloon encapsulated in the microcapsule. Upon ascertaining the full inflation based on the endoscopic visualization, the investigator will wait another 10 minutes after that to observe how the subject feels before manually puncturing the balloon with needle knife, and retrieving the punctured balloon with the RothNet through the mouth.
15885644|NCT03760848|Drug|Aramchol|Aramchol 600 mg
15885645|NCT03760848|Drug|Midazolam|Midazolam 2 mg
15885646|NCT03760848|Drug|Atorvastatin|atorvastatin 40 mg
15885647|NCT03760835|Drug|Conventional Glucocorticoids (immediate release hydrocortisone, cortisone acetate, prednisone, prednisolone, dexamethasone)|Treatment of congenital adrenal hyperplasia
15889015|NCT03735303|Dietary Supplement|omega 3 FA group|omega 3 FA group 300 mg once daily for 8 weeks
15885652|NCT03760809|Drug|Dexmedetomidine 1μg／kg|Group B received dexmedetomidine 1μg／kg (diluted to 100ml，influded in 5 mins at the beginning of the surgery) and hydromophine 0.03 mg／kg as a bolus.
15885653|NCT03760796|Device|Corrie Health Digital Platform|The Corrie Health Digital Platform consists of the Corrie smartphone app for heart attack recovery which is paired with an Apple Watch and Bluetooth-enabled, iHealth blood pressure monitor.
15885654|NCT03760783|Other|Parabolic flight|Sperm analysis (total motility M/ml; grade a+b sperm M/ml, vitality, DNA Frag and apoptosis) will be measured on ground at 1g before the flight and after flight were sperm samples have been exposed to simulated microgravity
15885655|NCT03760770|Procedure|corneal collagen crosslinking|Crosslinking in patients with progressive keratoconus.
15885656|NCT03760757|Dietary Supplement|ESPO-572®|ESPO-572® is the same as PCSO-524®, except it has krill oil added to it.
15885657|NCT03760757|Dietary Supplement|PCSO-524®|PCSO-524® (Lyprinol®/Omega XL®) is a nutritional supplement containing a patented extract of highly condensed form of stabilized marine lipids from the New Zealand green lipped mussel (Perna canaliculus) that is combined with olive oil and vitamin E. This marine oil lipid and omega-3 polyunsaturated fatty acid (PUFA) blend is a diverse mixture of sterol esters, sterols, polar lipids, triglycerides, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (split between the triacylglycerol and polar lipid classes), and free fatty acids.
15885658|NCT03760744|Procedure|CDT with Negative Pressure|Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) in conjunction with manual intervention of graded negative pressure application for lymphatic stimulation/ tissue clearance
15885659|NCT03760744|Procedure|CDT alone|Complete decongestive therapy (physical therapy conservative intervention of compression, manual lymphatic drainage, skin care and exercises) for lymphatic stimulation/ tissue clearance
15885660|NCT03760731|Behavioral|Acceptance and Commitment Therapy for Moral Injury (ACT-MI)|Acceptance and Commitment Therapy for Moral Injury (ACT-MI) is a novel treatment protocol detailing the application of ACT for recovery from moral injury. ACT-MI is designed to help Veterans learn to interact differently with moral emotions and engage meaningfully in their lives. The intervention is group-based and spans twelve, 90-minute sessions. The current ACT-MI protocol was developed through an iterative process in which authors generated and refined the intervention based on clinical interactions with Veterans currently reporting moral injury.
15885661|NCT03760731|Behavioral|Present Centered Therapy (PCT)|Present Centered Therapy (PCT) will include 12 group sessions, but will focus on problem solving daily life difficulties related to moral injury rather than the experiential focus on moral emotions presented in ACT-MI. Because PCT has been established as an evidence-based active control condition, it is likely to serve as a beneficial transdiagnostic intervention in its own right.
15885662|NCT03760718|Drug|Preservative free 1% Chloroprocaine|40 ml of preservative-free 1% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
15885663|NCT03760718|Drug|Preservative free 2% Chloroprocaine|40 ml of preservative-free 2% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
15885664|NCT03760718|Drug|Preservative free 3% Chloroprocaine|40 ml of preservative-free 3% chloroprocaine is planned for administration into the peritoneal cavity after delivery of the baby.
15885665|NCT03760705|Other|Data Collection|"Collection of data as detailed below:
~Clinical data collected by SCDB
~Clinical, administrative, pharmacy, financial data collected by each participating hospital
~Administrative data collected by MOH
~Data will be extracted and anonymized on a secure healthcare analytics platform
~Collaboration with the MOH for collection of administrative and financial data
~Analysis on how healthcare behavior is affected by education, socioeconomic level and other social or cultural factors.
~Statistical Analysis by the bio statistical team. This team will be responsible for collecting and merging the collected data and will also ensure the quality of the data."
15885666|NCT03760692|Device|i-gel|Evaluation of clinical performance in terms of insertion, ventilation and complications
15885667|NCT03760692|Device|Ambu AuroGain|Evaluation of clinical performance in terms of insertion, ventilation and complications
15885668|NCT03760679|Device|Laryngeal mask Supreme evaluation|Device: Laryngeal mask Supreme evaluation
15885669|NCT03760679|Device|i-gel evaluation|Device: i-gel evaluation
15885670|NCT03760666|Drug|Brequinar|Oral brequinar will be administered twice-weekly. After the first cohort of 6 subjects, dose adjustments can occur every 14-day cycle both at the intra-subject and the inter-cohort level depending on safety, efficacy, and biomarker levels.
15885671|NCT03760666|Drug|Brequinar + Ribavirin|Cohort 2 subjects start dosing with brequinar alone twice weekly and may roll over into brequinar twice weekly + ribavirin BID. Cohort 3 subjects start with brequinar alone twice weekly then add ribavirin dosing BID.
15885672|NCT03760653|Other|Physical Exercise and probiotic group|The exercise intervention will last 12 weeks. It will include three weekly sessions of programmed physical exercise of ~ 60 min duration (aerobic and strength combined training). The exercise sessions will be individualized and will follow the rules of the world reference institutions for aerobic training. Each session will be held in a authorized fitness center and it will be supervised and individualized for each subject by expert professionals.The probiotic will be taken (3 capsules/day) for 12 weeks. Each probiotic capsule contains Lactobacillus rhamnosus, Lactobacillus paracasei, Lactobacillus acidophilus, Bifidobacterium bifidum.
15885673|NCT03760653|Dietary Supplement|Probiotic group|Probiotic supplementation (3 capsules/day) will be taken before bedtime for 12 weeks.Each probiotic capsule contains Lactobacillus rhamnosus, Lactobacillus paracasei, Lactobacillus acidophilus, Bifidobacterium bifidum.
15885674|NCT03760653|Dietary Supplement|Placebo group|Subjects will take 3 capsules/day of placebo capsules (maltodextrin) for 12 weeks
15885675|NCT03760640|Drug|LY900014|Administered SC
15885676|NCT03760640|Drug|Insulin Lispro|Administered SC
15885774|NCT03759873|Behavioral|Incentives|Patient earns financial incentives (gift cards) on an escalating schedule for completing cardiac rehabilitation sessions.
15886192|NCT03756857|Procedure|Trial followed by transfer|"Embryo transfer is done by using afterload transfer method"
15885679|NCT03760614|Drug|Entinostat|Entinostat will be administered orally on days 1, 8, 15 and 22 of each 28-day cycle.
15885680|NCT03760614|Drug|FOLFOX regimen|FOLFOX will be administered intravenously (IV), into a vein, using a port-a-cath every 2 weeks.
15885681|NCT03760601|Behavioral|Brief cognitive intervention|A one-session intervention with a researcher including a simple cognitive task (a memory cue, 10 minutes time gap and ca. 20 minutes of Tetris game play) with instructions to engage in the task self-guided in the subsequent week.
15885682|NCT03760588|Drug|Sacubitril/valsartan|Target dose 97/103 mg b.i.d .
15885683|NCT03760575|Drug|Pembrolizumab|Pembrolizumab 200mg via IV infusion every 3 weeks for 2 cycles 3 pre-surgery, for 4 cycles post-surgery and then every 3 weeks during maintenance.
15885684|NCT03760575|Procedure|Indocyanine Green (ICG) Image-Guided Surgery|Standard surgery with image guided resection.
15885685|NCT03760575|Drug|Cisplatin|75 mg/m2 every 3 weeks via IV infusion for 4 cycles post-surgery.
15885686|NCT03760575|Drug|Pemetrexed|500 mg/m2 every 3 weeks via IV infusion for 4 cycles post-surgery.
15885687|NCT03760562|Drug|Glucocorticoids|Oral Glucocorticoids.
15885688|NCT03760549|Drug|Subjects were administered NasoVAX high dose|NasoVAX administered by intranasal spray at a single dose of 1×10(11th) viral particles (vp) versus placebo
15885689|NCT03760536|Behavioral|16-week Exercise Rehabilitation Program for Breast Cancer Survivors|Interested patients will attend a group meeting where they will be screened and consented to the study. During weeks 1 and 2 patients will complete pre-intervention baseline assessments and blood draws followed by a 16-week supervised exercise program at Get REEL and HEAL facility. Study participants will complete progressive aerobic and resistance exercise training. Post-intervention weeks 1 and 2 participants will complete assessments, questionnaires and blood draws. Participants will be followed up at 6 and 12 months post intervention with physical assessments, questionnaires and blood draws. Annual follow-up will occur at year 2,3,4 and 5 post intervention with questionnaires only.
15885690|NCT03760523|Drug|Minnelide|Patients will take Minnelide orally once daily on Days 1-21 of 28 day Cycle. Dose Escalation Schedule: Dose Level -1: .5 mg, Dose Level 1: .75 mg, Dose Level 2: 1 mg, Dose Level 3: 1.25 mg.
15885691|NCT03760510|Device|Tube Fastener|Endotrachel tube secured with tube fastener
15885692|NCT03760510|Device|Adhesive Tape|Endotracheal tube secured with adhesive tape.
15885693|NCT03760497|Procedure|Restorative treatment|For all groups, first the patients will be submitted to the anesthetic technique indicated with Lidocaine + Epinephrine 1: 100,000 (New DFL, Rio de Janeiro, Brazil), followed by absolute isolation with rubber sheet and metal clamp; then prophylaxis of the selected tooth will be performed with Robson's brush and pumice stone and water, surface washing and drying with cotton balls, removal of carious tissue or affected enamel without dentin support with sharp curettes or low-speed spherical drills. Subsequently, each group will follow the treatment protocols suggested by the manufacturer of restorative materials.
15885694|NCT03760484|Drug|Fidaxomicin 200 mg|Each cycle consists of fidaxomicin 200 mg PO bid x 7-10 days till clinical efficacy is achieved, to a max of 4 cycles.
15885695|NCT03760484|Biological|fecal microbiota transplantation (FMT)|Each cycle consists of FMT per rectum daily x 3 days till clinical efficacy is achieved to a max of 4 cycles
15885696|NCT03760471|Other|Evidenced-based symptom management and coping intervention|The intervention visits will focus on coping and the following symptoms prevalent during CRT: (1) pain and mucositis, (2) nausea, (3) constipation, (4) fatigue, (5) sleep disturbances, (6) xerostomia, (7) thick mucus, and (8) depression
15885699|NCT03760445|Drug|HDM201|2.5 mg and 10mg capsules, given orally
15885700|NCT03760445|Drug|cytarabine|20mg or 1000 mg or other strengths as locally available given intravenously
15885701|NCT03760445|Drug|anthracycline|20mg or other strength as locally available given intravenously
15885702|NCT03760445|Drug|midostaurin|25mg capsules given orally
15885703|NCT03760445|Drug|liposomal cytarabine/daunorubicin|100mg/44mg or other strength as locally available given intravenously
15885704|NCT03760445|Drug|posaconazole|100mg delayed release tablet or other strength as locally available given orally
15885705|NCT03760445|Drug|midazolam|2mg/mL oral solution or in other strength as locally available
15885706|NCT03760432|Procedure|Laser Custom Corneal Collagen Cross-Linking|Preoperative measurements from the OCT are used to assist the calculation in deciding the laser depth settings for smoothing the anterior corneal surface and removing any present opacities. The surgeon uses the OCT data to plan treatment parameters while preserving at least 360 microns of residual corneal stroma using a phototherapeutic keratectomy procedure. After the laser procedure, adjunctive MMC or saline solution will be applied to the cornea in accordance with the group to which the treated eye is randomized. The CXL procedure is then performed following the FDA-approved CXL regimen by Avedro, Inc.
15885707|NCT03760419|Behavioral|Decision Support|For enrolled subjects assigned to the decision support arm, providers will receive antibiotic recommendations in accordance with the 2011 PIDS/IDSA guideline, tailored to site of care and illness severity. The tool will offer treatment recommendations only and will not proscribe a specific treatment plan. Providers will receive prognostic information derived from the previously validated and best performing model. The application will calculate predicted risk for moderate (intensive care) and severe (respiratory failure or shock) outcomes using the parameters derived from the prognostic tool's regression equation. The tool will offer prognostic information only and will not proscribe a specific site of care or management plan.
15885708|NCT03760406|Procedure|Opti-VIM targeting in DBS surgery|DBS surgery will be performed under general anaesthesia, without intra-operative clinical and electrophysiological testing, with a surgical robot and under CT-scan guidance (O-Arm ©). The VIM coordinates will be calculated with the probabilistic model that have been developed.
15885709|NCT03760393|Behavioral|(SB-related planning + daily text messages)|"Participants will receive a one-on-one behavioral counseling session, and planning sheet as reference for developing strategies as part of their Action/Coping Plan. Participants will be asked to form 3-4 actions plans specifying when, where, how, and for how long they would reduce occupational (student) sitting time; and anticipate potential barriers and identify ways they could be overcome. Strategies will explicitly focus on the ultimate objective of increasing break frequency to every 30-45 minutes, achieving a break duration of 2-3 minutes, and increasing time spent standing and engaged in light-intensity PA, in the occupational domain (i.e. as a student; during school-related activities).
~Participants will also receive sedentary behaviour-related text messages twice daily, depending on their preferences and schedule, which will act as mini-booster interventions."
15885710|NCT03760380|Device|Sole 1 - Neutral|Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in arthritic knee patients. The gait-modifying shoes will initially be neutrally aligned to create the smallest amount of instability. This is defined as the location which creates the smallest amount of instability.
15885711|NCT03760380|Device|Sole 1 - Offset|Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in arthritic knee patients. The offset sole will be placed in a position that may reduce the knee adduction moment. The anterior elements will be placed 1 cm medially from the neutral position and the posterior pod will be moved 1 cm laterally from the neutral position.
15885712|NCT03760380|Device|Sole 2 - Neutral|Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in arthritic knee patients. The gait-modifying shoes will initially be neutrally aligned to create the smallest amount of instability.This is defined as the location which creates the smallest amount of instability.
15885713|NCT03760380|Device|Sole 2 - Offset|Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in arthritic knee patients. The offset sole will be placed in a position that may reduce the knee adduction moment. The anterior elements will be placed 1 cm medially from the neutral position and the posterior pod will be moved 1 cm laterally from the neutral position.
15885714|NCT03760367|Other|Blue covarine toothpaste|2 min toothbrushing with 1 g of Pepsodent White Now Gold
15885715|NCT03760367|Other|Control toothpaste|2 min toothbrushing with 1 g of Colgate Advanced Whitening
15885716|NCT03760354|Drug|Methylprednisolone|Dose: 500mg/day for the first two days then 2mg/kg per day for three days. Dilution in 0.9% NaCl, 100 ml as a single slow intravenous administration over 60 minutes Total processing time of 5 days
15885717|NCT03760354|Other|Placebo|NaCl 0.9%, 100ml per day as a single slow intravenous administration over 60 minutes for a total treatment duration of 5 days
15885718|NCT03760341|Procedure|adenoidectomy - cold method|a surgery for adenoid removal or reduction under general anesthesia using surgical curretes
15885719|NCT03760341|Procedure|adenoidectomy - hot method|a surgery for adenoid removal or reduction under general anesthesia using suction diathermy
15885720|NCT03760328|Device|Upper Airway Stimulation|hypoglossal nerve stimulation by using a breathing cycle depended stimulation system of the upper airway
15885721|NCT03760315|Diagnostic Test|mNGS (Next-Generation Sequencing Technology); Culture|mNGS and Culture of microbe in sepsis patients
15885722|NCT03760302|Other|analgesics|analgesics given to a patient treated from HEMS
15885723|NCT03760302|Other|hypnotics|hypnotics given to a patient treated from HEMS
15885724|NCT03760276|Drug|Voriconazole Oral Product (Vfend®)|To be determined mg of Voriconazole (Vfend®, anti-fungal agent)
15885725|NCT03760263|Drug|Tacrolimus|Immunosuppressive drug that can prevent organ rejection after transplant in its oral form.
15885726|NCT03760250|Drug|Imiquimod 5% cream|Imiquimod 5% Cream application to keloid skin area 5-times per week for 6 weeks, starting 1-week before keloid excision
15885727|NCT03760237|Other|observation only|No intervention, observational study only
15885728|NCT03760224|Other|WhatsApp group|WhatsApp group will allow real-time group discussion for 8 weeks
15885729|NCT03760224|Other|SMS group|SMS group for 8 weeks
15885730|NCT03760211|Behavioral|Multilevel Gaming Adherence Intervention|Combination of electronic medication monitoring device with Information-Motivation-Behavior based mobile gaming application tailored for those living with HIV and adherence-based text messages
15885731|NCT03760211|Behavioral|Treatment as Usual +|Combination of electronic medication monitoring device and non-HIV related mobile gaming application
15885732|NCT03760198|Drug|Meditoxin|50U of MEDITOXIN is injected intradermally to each axilla
15885733|NCT03760198|Other|Placebo|normal saline is injected intradermally to each axilla
15885734|NCT03760185|Drug|Brimonidine Tartrate|All subjects will apply brimonidine tartrate to one eye only for the duration of study participation.
15885735|NCT03760159|Device|Kinocardiography unintrusive recording|"The Kinocardiography (Kino) is a device which records the electric and mechanic function of the heart. The device comprises a combination of ECG recording, (6 degrees of freedom), accelerometer and gyroscope sensors. The Kino device consists of a back and a chest housing in contact with the patient. The back housing is placed in the middle of the lower back of the patient, and the chest housing is placed on the chest (either on the sternum or on the costal grill at the apex of the heart). The housings are connected by two cables. Data obtained from the device are visualized on a digital application via a Bluetooth connection.
~For the group A, the KCG records the cardiac signals while the patient performs specific respiratory manoevres, as describe above.
~For group B, C, D, the KCG records the cardiac contraction during sleep along with the PSG recording."
15885736|NCT03760146|Biological|20vPnC|20vPnC
15885737|NCT03760146|Biological|13vPnC|Pneumococcal conjugate vaccine
15885738|NCT03760146|Biological|PPSV23|Pneumococcal polysaccharide vaccine
15885739|NCT03760146|Other|Saline|Placebo
15885740|NCT03760133|Drug|Duolac|Participants included in this group will be taken probiotics for 1 month after bowel preparation for colonoscopy.
15885741|NCT03760120|Device|PEP-MASK|
15885742|NCT03760107|Behavioral|Connect Smokers to Treatment 1|Using a factorial experimental design, the investigators evaluate how coupling a population-based, direct mail intervention with (1) financial incentives and (2) proactive telephone outreach influences connections to evidence-based tobacco treatment services among low-SES smokers.
15885743|NCT03760107|Behavioral|Connect Smokers to Treatment 2|Using a factorial experimental design, the investigators evaluate how coupling a population-based, direct mail intervention with (1) financial incentives and (2) proactive telephone outreach influences connections to evidence-based tobacco treatment services among low-SES smokers.
15885744|NCT03760107|Behavioral|Connect Smokers to Treatment 3|Using a factorial experimental design, the investigators evaluate how coupling a population-based, direct mail intervention with (1) financial incentives and (2) proactive telephone outreach influences connections to evidence-based tobacco treatment services among low-SES smokers.
15885745|NCT03760107|Behavioral|Connect Smokers to Treatment 4|Using a factorial experimental design, the investigators evaluate how coupling a population-based, direct mail intervention with (1) financial incentives and (2) proactive telephone outreach influences connections to evidence-based tobacco treatment services among low-SES smokers.
15885746|NCT03760107|Behavioral|Connect Smokers to Treatment 5|Using a factorial experimental design, the investigators evaluate how coupling a population-based, direct mail intervention with (1) financial incentives and (2) proactive telephone outreach influences connections to evidence-based tobacco treatment services among low-SES smokers.
15885747|NCT03760107|Behavioral|Connect Smokers to Treatment 6|Using a factorial experimental design, the investigators evaluate how coupling a population-based, direct mail intervention with (1) financial incentives and (2) proactive telephone outreach influences connections to evidence-based tobacco treatment services among low-SES smokers.
15885748|NCT03760094|Device|Colour Doppler|evaluation of lymph nodes by Doppler
15885749|NCT03760081|Drug|ASP1650|intravenously (IV)
15885750|NCT03760068|Drug|MYL-1601D Product|(100 U/mL)
15885751|NCT03760068|Drug|FlexPen NovoLog®|(100 U/mL)
15885752|NCT03760055|Device|nGoggle|The nGoggle is a portable visual evoked potential system that uses an EEG to acquire visual evoked potentials in response to visual stimuli presented on a virtual reality goggle. The investigators will assess the ability of the nGoggle to detect visual field loss in patients with glaucoma, as well as to discriminate among the different stages of the disease, its repeatability and reliability for patient self-testing and patient satisfaction compared to standard automated perimetry (SAP), optical coherence tomography (OCT) metrics and Diopsys NOVA (Diopsys, Inc.). In addition, patients with other diseases affecting the visual system will also be tested in order to assess whether the nGoggle can differentiate glaucoma from them.
15885753|NCT03760042|Drug|Within-Subject Active vs Placebo Topical Applications|Crisaborole 2% ointment (right side) and Placebo vehicle ointment (left side)
15885754|NCT03760042|Drug|Within-Subject Active vs. Placebo Topical Applications|Crisaborole 2% ointment (left side) and Placebo vehicle ointment (right side)
15885755|NCT03760029|Other|Visit frequency|All subjects need to visit sites more frequently than in routine clinical practice.
15885756|NCT03760016|Behavioral|Moderate-Intensity Aerobic Training|Overground and treadmill walking with speed continuously adjusted to maintain a target heart rate of 40 +/- 5% heart rate reserve, progressing up to 55 +/- 5% heart rate reserve.
15885757|NCT03760016|Behavioral|High-Intensity Interval Training|Overground and treadmill walking with 30 second bursts at maximum speed alternated with 30-60 second passive recovery periods. Intended to achieve a target average heart rate above 60% heart rate reserve.
15885758|NCT03760003|Drug|ABX464 25mg|ABX464 25mg (One capsule of ABX464 25 mg + One capsule of placebo) once daily for 16 weeks
15885759|NCT03760003|Drug|ABX464 50mg|ABX464 50mg (One capsule of ABX464 50 mg + One capsule of placebo) once daily for 16 weeks
15885760|NCT03760003|Drug|ABX464 100mg|ABX464 100mg (two capsules of ABX464 50 mg) once daily for 16 weeks
15885761|NCT03760003|Drug|Placebo|Two capsules of placebo once daily for 16 weeks
15885762|NCT03759990|Device|lean|Videolaryngoscope used in intubation
15885763|NCT03759990|Device|obese|Videolaryngoscope used in intubation
15885764|NCT03759977|Other|Adapted Physical Activity|The sessions of Adapted Physical Activity will be focus around the theme of balance, with a small part of resistance training.
15885765|NCT03759964|Drug|Ferric carboxymaltose|1g of Ferric carboxymaltose diluted in 100 mL of IV isotonic serum saline at day 1 following surgery
15885766|NCT03759964|Drug|Placebo|100 mL of IV isotonic serum saline at day 1 following surgery
15885767|NCT03759951|Behavioral|DoIT-1|A hybrid small-group (5-10 participants/session) training modality, that combines interval training, circuit-based resistance exercise and functional training and performed according to a periodized model of exercise prescription as an alternative approach for weight management, health, performance and well-being. DoIT will be performed once per week on non-consecutive days for 12 months.
15885768|NCT03759951|Behavioral|DoIT-2|A hybrid small-group (5-10 participants/session) training modality, that combines interval training, circuit-based resistance exercise and functional training and performed according to a periodized model of exercise prescription as an alternative approach for weight management, health, performance and well-being. DoIT will be performed twice per week on non-consecutive days for 12 months.
15885769|NCT03759951|Behavioral|DoIT-3|A hybrid small-group (5-10 participants/session) training modality, that combines interval training, circuit-based resistance exercise and functional training and performed according to a periodized model of exercise prescription as an alternative approach for weight management, health, performance and well-being. DoIT will be performed thrice per week on non-consecutive days for 12 months.
15885770|NCT03759951|Behavioral|Control|No training will be performed during a 1-year period. Participation only in measurements.
15885771|NCT03759938|Drug|Direct oral anticoagulant (DOAC)|Any of the DOACs listed above may be used for treatment in either study arm. The DOAC will be supplied from normal hospital stock, using local hospital prescriptions.
15885772|NCT03759925|Other|Nutritional Support|Weekly nutritional components: Month 1: equivalent of 3 meals/day in the form of 14 frozen meals, and breakfast bag with items to prepare 7 breakfast meals. Month 2: equivalent of 3 meals a day in the form of 7 frozen meals, grocery bags, and breakfast bags with items to prepare 7 breakfast meals. Month 3: the equivalent of 2 meals a day in the form of 7 frozen meals and grocery bags. Month 4: Participant choice to receive either 7 frozen meals or grocery bag with equivalent food for 1 meal a day. Month 5: Grocery bag with equivalent food for 1 meal a day Nutritional counseling component: Individual counseling with Registered Dietician monthly
15885773|NCT03759886|Drug|Paromomycin Sulfate Powder|The patients receive Paromomycin and Metronidazole the day prior to colorectal surgery after mechanical bowel preparation
15885775|NCT03759873|Behavioral|Case Management|A case manager is available by phone to assist patient with attending cardiac rehabilitation sessions as well as to provide advice about cardiac symptoms and healthy behavior change.
15885776|NCT03759860|Combination Product|R:GEN laser treatment (Selective Retina Therapy) and Lucentis (ranibizumab) combination therapy|Lucentis (ranibizumab) injection into the vitreous cavity after R:GEN laser treatment (Selective Retina Therapy)
15885777|NCT03759847|Other|Fluid intake app|Use of fluid app to monitor intake of fluids
15885778|NCT03759847|Other|Survey|A survey will be used to assess the usability of the app (ease of use in general, ease of capturing fluid intake data, including the choice of pre-selected volumes for fluid containers, reasons for not using the app more frequently, the usefulness of the app notifications, ease of sending data to the study coordinator for review) as well as to collect recommendations for changes to the app itself.
15885779|NCT03759834|Device|Cochlear promontory stimulation|Promontory stimulation is an established otologic procedure that was initially developed as a diagnostic tool to assess patient candidacy for cochlear implantation. Promontory stimulation is most commonly performed in the outpatient setting on an awake patient by placing a single insulated probe through a topically anesthetized tympanic membrane and applying monopolar current for several seconds to minutes. The initial session of promontory stimulation will define optimal stimulation parameters (i.e., location, current level, pulse-width, phase polarity), where maximal tinnitus suppression occurs with minimal or no auditory percept. Additional stimulation testing visits will confirm these findings.
15885780|NCT03759821|Behavioral|Nutrition, mothers|Nutrition-related social and behavior change (SBC) messages and activities for mothers focused on infant and young child feeding (IYCF), dietary diversity, water, sanitation, and hygiene (WASH), food access (use of income and home-grown foods), psychosocial well-being, gender equity, intra-household resource allocation, partner communication and household decision-making
15885781|NCT03759821|Behavioral|Nutrition, mothers and fathers|Nutrition-related social and behavior change (SBC) messages and activities for mothers and fathers focused on infant and young child feeding (IYCF), dietary diversity, water, sanitation, and hygiene (WASH), food access (use of income and home-grown foods), psychosocial well-being, gender equity, intra-household resource allocation, partner communication and household decision-making
15885782|NCT03759821|Behavioral|Nutrition+parenting, mothers|Nutrition- and parenting-related social and behavior change (SBC) messages and activities for mothers focused on infant and young child feeding (IYCF), dietary diversity, responsive caregiving and child stimulation (play and communication), water, sanitation, and hygiene (WASH), food access (use of income and home-grown foods), psychosocial well-being, gender equity, intra-household resource allocation, partner communication and household decision-making
15885783|NCT03759821|Behavioral|Nutrition+parenting, mothers and fathers|Nutrition- and parenting-related social and behavior change (SBC) messages and activities for mothers and fathers focused on infant and young child feeding (IYCF), dietary diversity, responsive caregiving and child stimulation (play and communication), water, sanitation, and hygiene (WASH), food access (use of income and home-grown foods), psychosocial well-being, gender equity, intra-household resource allocation, partner communication and household decision-making
15885785|NCT03759795|Behavioral|ACTr (Acceptance and Commitment Training)|The programme is based on Acceptance and Commitment Training (ACT), a contemporary, empirically supported approach to psychological well-being.
15885786|NCT03759782|Drug|Ribavirin|Ribavirin will be added to the standard of care treatment (tenofovir) regime for 24 weeks.
15885787|NCT03759782|Drug|Tenofovir|Tenofovir as per standard of care
15885788|NCT03759769|Other|Wheelchair simulator|Computer application providing 3D first person view of a wheelchair, with six different activities: street crossing, entering an elevator, entering an adapted van, bathroom, shopping mall and supermarket
15885789|NCT03759769|Other|Video game|'Kart' driving video game
15885790|NCT03759756|Other|AI presentation|AI presentation means the automatic diagnosis information of AI and AI presentation means it is visible in the group.
15885791|NCT03759756|Other|no AI presentation|AI presentation means the automatic diagnosis information of AI and no AI presentation means it is invisible in the group.
15885792|NCT03759743|Dietary Supplement|LMT1-48|capsules containing Probiotics
15885793|NCT03759743|Dietary Supplement|Placebo|capsules that did not contain any probiotics
15885794|NCT03759717|Other|Observation|Understanding the biology of skull base tumors will teach the investigators about the genesis and/or mechanisms of treatment resistance. The investigators hope to ultimately identify new targets which will add to the armamentarium by which to treat these tumors.
15885795|NCT03759704|Drug|Hyperpolarized 13CPyruvate|Bolus injection of study drug during MRSI.
15885796|NCT03759691|Behavioral|Structured interview|Interview contains questions about stroke knowledge and help-seeking behaviour on the day the stroke occured.
15885797|NCT03759678|Drug|IB1001|IB1001 (N-Acetyl-L-Leucine) is a modified amino-acid ester that is orally administered.
15885798|NCT03759665|Drug|IB1001|IB1001 (N-Acetyl-L-Leucine) is a modified amino-acid ester that is orally administered.
15885799|NCT03759652|Behavioral|before-after study|The data analysed involve the time when the targeted, active surveillance of infections was establised, initially: 2003-2017, using tools (definitions, protocols) in accordance with the National Healthcare Safety Network (NHSN), then from 2012, HAI recognition methodology and HAI record-keeping has followed the Surveillance Network (HAI-Net), European Centre for Disease Prevention and Control (ECDC).
15885800|NCT03759639|Drug|IB1001|IB1001 (N-Acetyl-L-Leucine) is a modified amino-acid ester that is orally administered.
15885830|NCT03759314|Other|Observation|to use a simple screening tool to find out the risk of falling, the nutritional status and the level of cognitive functioning activity
15885801|NCT03759626|Behavioral|Impulsive intervention|"As part of the IMAJe project, a 20 min TV series pilot for teenagers was developed by C. Russel of Washington University : Tom in the making. The results of the study show that the mere diffusion of this pilot mobilizes the individual's impulsive system described in the theoretical model developed by Strack and Deutsch. 2 different versions have been developed. Both have the same basic story in three acts with the same main characters. Only the last acts vary according to the consequences of alcohol consumption. The first version shows a positive representation of alcoholization, the other highlights the negative consequences generated by this behaviour. Our tool will be the so-called negative version of the episode where alcohol consumption causes harmful consequences in the young person's life. Following this 20 min episode, a 25 min debate focusing on the characters in the series will be conducted using a questionnaire grid with 8 questions."
15885802|NCT03759626|Behavioral|Reflective Intervention|"This intervention uses modules of the KOTTABOS ® system produced by the National Association for the Prevention of Alcohol and Addiction 59 (ANPAA) and validated by the Interministerial Mission to Combat Drugs and Drug Addiction (MILT). For young people, this educational tool aims to develop an understanding of the mechanisms of blood alcohol levels, the effects and immediate risks associated with alcohol consumption.
~It encourages individual and collective reflection on the effects of alcohol on physical, cognitive and intellectual abilities in order to increase individual skills in making risk-appropriate behavioural choices. This pedagogical tool is based on a participatory and experimental approach. 5 devices of the KOTTABOS ® tool were selected and tested with 2 test groups of adolescents of the same school level as the students in the study."
15885803|NCT03759613|Other|Gait Analysis|"Gait Analysis: Gait analysis is not a routine assessment tool for upper extremity burn injuries. This analysis is an assessment method to estimate gait symmetry.
~Restriction arm swing: Participants in group will be restricted for arm swing using a bandage. Thus, the reciprocal arm swing will be prevented."
15885804|NCT03759600|Drug|Niraparib|Niraparib capsule
15885805|NCT03759587|Drug|Niraparib|Niraparib capsule
15885806|NCT03759561|Procedure|intubation with videolaryngoscope vs fiberoptic bronchoscope|Tracheal intubation was performed using either videolaryngoscope or fiberoptic bronchoscope under cervical collar application according to the group allocations
15885807|NCT03759548|Other|Assessment of nutritional status|Observational study. Assessment of nutritional status.
15885808|NCT03759535|Diagnostic Test|Acute rejection|Donor derived cell free DNA
15885809|NCT03759522|Drug|DPA-714 PET/MRI|DPA-714 PET/MRI
15885810|NCT03759509|Behavioral|aerobic exercise|the experimental group, in which aerobic exercise training is given three times a week, a total of twenty-four times in eight weeks
15885811|NCT03759496|Biological|Durvalumab|Durvalumab is a human monoclonal antibody (mAb) of the immunoglobulin G (IgG) 1 kappa subclass
15885812|NCT03759483|Diagnostic Test|AI diagnostic algorithm|The visual fields collected would be assessed by the algorithm and ophthalmologists independently. The performance of the algorithm and the ophthalmologists would be compared, including accuracy, AUC, sensitivity and specificity.
15885813|NCT03759470|Diagnostic Test|CSF examination|"The CSF samples will be stored at -80°C until testing . CSF specimens will be prepared for GS and culture examinations by centrifugation at 3,000 rpm for 10 minutes at room temperature. Culture will be performed by inoculating 1-2 drops of CSF sediment directly onto each of the following agar plates: horse-blood agar, Thayer-Martin agar, choc- olate agar and Sabouraud agar. Moreover, a broth tube (brain-heart infusion, BHI) will be inoculated with one drop of the sediment. Agar plates and broth will be incubated for 1 to 5 days at 35-37°C (with ~5% CO2, or in a candle-jar, for Thayer-Martin and chocolate agar) .
~In addition to GS and culture method , India ink test and culture and latex agglutination test (LAT). LAT assay will be performed on CSF samples using Latex-antigen detection system kit."
15885814|NCT03759457|Device|High Flow Nasal Cannula (AIRVO2)|High-flow nasal cannula (HFNC) delivers oxygen flows of up to 60 L/min. The gas source (air/oxygen blender, ventilator, or turbine flow-generator) is connected via an active heated humidifier to a nasal cannula and allows FiO2 adjustment independently from the flow
15885815|NCT03759444|Other|Questionnaires|The three questionnaires applied were: the Time Metaphors Questionnaire by Sobol-Kwapinska, the Time Perspective Inventory by Zimbardo, and the UWIST Mood Adjective Checklist (UMACL) by Matthews et al.
15885816|NCT03759431|Radiation|Vocal-cord Radiotherapy|Focal radiotherapy limited to the involved vocal cord(s) plus additional margins accounting for respiration and set-up errors.
15885817|NCT03759431|Radiation|Complete Larynx Radiotherapy|Radiotherapy to the entire larynx, with target volumes defined to lead to traditional volumes from conventional complete larynx radiotherapy.
15885818|NCT03759418|Device|exclusion of the left atrial appendage|A trans esophageal echocardiogram will be performed to assess the Atriclip device in the closure of the left atrial appendage in patients that had surgery at least 12 months ago.
15885819|NCT03759405|Biological|iPS differentiated cardiomyocytes|Repair of injured myocardium by vein transplantation with autologous iPS differentiated cardiomyocytes
15885820|NCT03759392|Drug|Omecamtiv Mecarbil|Oral omecamtiv mecarbil twice daily for up to 20 weeks with dose level determined by periodic blood testing
15885821|NCT03759392|Drug|Placebo|Oral placebo twice daily for up to 20 weeks
15885825|NCT03759353|Diagnostic Test|Baseline ferritin level|At enrollment, baseline serum ferritin level will be assessed to quantify iron deficiency.
15885826|NCT03759353|Drug|Lactoferrin|lactoferrin 100 mg one sachet twice daily for 30 days to be dissolved in 1/4 glass of water before meals (Pravotin, Hygint pharmaceuticals).
15885827|NCT03759353|Drug|Ferrous Sulfate|200 mg of dried ferrous sulphate tablet once daily for 30 days on empty stomach but may be taken with meals to avoid stomach upset.
15885828|NCT03759353|Diagnostic Test|Follow up ferritin level|Four weeks after treatment, serum ferritin level will be assessed to quantify effect if treatment on iron status.
15885829|NCT03759340|Drug|ATI 502 0.46% Topical Solution|apply ATI-502 Topical Solution, 0.46% Twice a day (BID) to the entire scalp and if applicable, the eyebrow(s)
15886043|NCT03757910|Drug|11C-PIB|This radiotracer will be used to detect amyloid. Participants will be injected with an intravenous bolus of up to 5-15 mCi.
15885831|NCT03759301|Drug|Growth Hormones Somatropin Recombinant|Growth Hormones Somatropin Recombinant 4 IU/day subcutaneous from the 2nd day of the cycle and stopped 1 day before ovum pickup
15885832|NCT03759301|Drug|Placebo saline solution|same volume as growth hormone ampule used
15885833|NCT03759288|Drug|Brazikumab low dose|Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48
15885834|NCT03759288|Drug|Brazikumab high dose|Intravenous Brazikumab on Days 1, 29, and 57, followed by subcutaneous Brazikumab on Day 85 and every 4 weeks through Week 48
15885835|NCT03759288|Drug|Humira®|Administered subcutaneously on Day 1, Day 15, and Day 29 and every 2 weeks through Week 50.
15885836|NCT03759288|Drug|Placebo|Intravenous placebo on Days 1, 29, 57 followed by subcutaneous placebo on Day 85 and every 4 weeks through Week 48
15885837|NCT03759275|Other|pMDT(Baseline Investigation)|The pMDT(Baseline Investigation) takes multi-model analgesia as the main technical means. Multimodal perioperative analgesia refers to the combination of analgesics, adjuvant drugs and analgesic techniques with different effects throughout the perioperative period to achieve the best curative effect of reducing postoperative acute and chronic pain.
15885838|NCT03759262|Drug|Cholecalciferol|A single dose of ultra-high-dose vitamin D (cholecalciferol) will be given prior to hematopoietic stem cell transplant. Research labs including inflammatory biomarker panels will be obtained prior to and after the dose is given.
15885839|NCT03759249|Other|Sleep medical treatment|"The participant ungo Standard Sleep medical diagnostics. If a sleep disorder is diagnosed in the interventional Group the applicable therapy is conducted.
~If the participant is randomized in the waiting Group the applicable Therapy is initiated after study completion."
15885840|NCT03759236|Behavioral|Health Messaging via SMS|This intervention aims to provide health education on topics including HPV Vaccination, Cervical Cancer screening, contraceptive methods, menstrual problems, diet and exercise geared towards women with children of vaccination age.
15885841|NCT03759236|Behavioral|CDC Health Pamphlets|This intervention aims to provide health education on the HPV Vaccination to women with children of vaccination age.
15885842|NCT03759223|Behavioral|Enhanced Problem-Solving Training|E-PST is a combined treatment that is comprised of brief problem-solving training and compensatory cognitive skills training.
15885843|NCT03759223|Behavioral|Healthy Living Messages|Healthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care.
15885844|NCT03759197|Drug|188-0551 Spray|Topical Spray containing active drug
15885845|NCT03759197|Drug|Vehicle Spray|Topical Spray containing no active drug
15885846|NCT03759184|Drug|rhIL-15|civ IL-15 at dose levels of 0.5,1 or 2 mcg/kg/day on days 1-5 of cycles 1-6
15885847|NCT03759184|Biological|obinutuzumab|intravenous (IV) obinutuzumab will be administered at a dose of 100 mg on day 4, 900 mg on day 5, 1,000 mg on day 11, and 1,000 mg on day 18 of cycle 1; then 1,000 mg on day 4 of each subsequent cycle
15885848|NCT03759171|Other|Guitars for Vets Intervention|This was an active intervention providing veterans with an acoustic guitar, guitar pick, tuning instruments, a music book, practice CDs, and individual and group sessions of music instruction during a 6-week intervention period. Six tailored 1-hour individual guitar instruction sessions were scheduled (1 session per week). In addition to the 6 tailored individual lessons, the intervention provided 3 group sessions. Veterans were given a guitar that they could keep upon completion of the program. The same instructor was assigned to a subject for the duration of the study, and group sessions were supervised by the Education Director of Guitars for Vets.
15885849|NCT03759158|Drug|N-Acetyl Cysteine|NAC 1200 mg twice daily one day prior to the procedure and on the day of the procedure.
15885850|NCT03759158|Drug|Placebo Oral Tablet|Placebo Oral Tablet twice daily.
15885851|NCT03759145|Other|Exergame|Participants use exergame with the therapist in the rehabilitation center. Several games are available, the therapist adjusts the choice of game and level of difficulty according to the participant's abilities and interests.
15885852|NCT03759145|Other|usual care|participants continued their planned rehabilitation sessions
15885853|NCT03759132|Procedure|Transcranial direct current stimulation|Transcranial direct current stimulation is a noninvasive technique of neuronal modulation that has been used in different chronic neurological conditions, including Parkinson's disease.
15885854|NCT03759119|Behavioral|Tummy time and parent education|Participants will receive tummy time positioning while awake for 10 minutes two times a day. Physiological monitoring will be maintained throughout the entire intervention and the intervention will be adjusted if needed to maintain stability. Participants will also receive parent education on tummy time prior to the tummy time intervention. The primary investigator will perform the tummy time intervention. Participants will be encouraged to continue performing tummy time on their own and record their adherence via the PT Pal application.
15885855|NCT03759119|Behavioral|Parent education only|"Participants will receive the same tummy time education as those in the intervention group and will be asked to continue the intervention on their own and record their adherence via the PT Pal application.
~Steps of the intervention for group 2 (standard care).
~Complete educational session with primary investigator.
~Adherence during the four-week intervention period will be measured remotely through the PT Pal® application."
15885856|NCT03759106|Other|home written exercise program|exercises such as picking up objects, placing objects, frequently prescribed at discharge
15885857|NCT03759106|Other|telerehabilitation/exergame system|Video games using the Kinect camera that are carried out using the impaired arm and monitored by a therapist by videoconferencing
15885858|NCT03759093|Drug|Bortezomib|Dose in the range of 0.7,1.0,1.3 or 1.5 mg/m2 subcutaneous (SC) injection on Day 1, 8, 15 ,22 for cycles 1 to 4 , as determined by the clinical care team according to standard of care
15885859|NCT03759093|Drug|Cyclophosphamide|Dose in range of 100, 150, 200, 250, 300, 350, 400, 450 or 500 mg per os (PO) on Day 1, 8, 15, 22 for cycles 1 to 4 as determined and guided by the clinical care team according to standard of care
15885860|NCT03759093|Drug|Dexamethasone|8, 12 , 16, 20, 24, 28, 32 , 36 or 40 mg PO on Day 1 ,8 , 15, 22 for cycles 1 to 4, as determined and guided by the clinical care team according to standard of care
15885861|NCT03759093|Other|CURATE.AI-Guided dosage modulation|CURATE.AI-guided modulation of Velcade and Cyclophosphamide dosages
15885862|NCT03759093|Drug|Thalidomide|Dose in a range of 50, 100, 150, 200 mg PO on day 1-28 for cycles 1 to 4 as determined and guided by CURATE.AI and approved by the clinical care team.
15885863|NCT03759093|Drug|Bortezomib|Dose in a range of 0.7,1.0,1.3 or 1.5 mg/m2 subcutaneous (SC) injection on Day 1, 8, 15 ,22 for cycles 1 to 4 , as determined and guided by CURATE.AI and approved by the clinical care team
15885864|NCT03759093|Drug|Cyclophosphamide|Dosing in a range of 100, 150, 200, 250 ,300, 350 ,400, 450 or 500 mg PO on Day 1, 8, 15, 22 for cycles 1 to 4 as determined and guided by CURATE.AI and approved by the clinical care team.
15885865|NCT03759093|Drug|Thalidomide|Dose in a range of 50, 100, 150, 200 mg PO on day 1-28 for cycles 1 to 4 as determined and guided by CURATE.AI and approved by the clinical care team.
15885866|NCT03759093|Drug|Dexamethasone|8, 12 , 16, 20, 24, 28, 32 , 36 or 40 mg PO on Day 1 ,8 , 15, 22 for cycles 1 to 4, as determined and guided by the clinical care team according to standard of care
15885867|NCT03759080|Procedure|mental practice|training of mental practice to do the pattern of proprioceptive neuromuscular facilitation
15885868|NCT03759080|Procedure|proprioceptive neuromuscular facilitation|upper limb Pattern: Flexion -Abduction- External rotation
15885869|NCT03759067|Drug|clopidogrel 75mg|clopidogrel once daily 75mg
15885870|NCT03759067|Drug|Clopidogrel 300 mg|clopidogrel 300mg reloading
15885871|NCT03759067|Drug|clopidogrel 600mg|clopidogrel 600mg loading
15885872|NCT03759041|Drug|Vancomycin Pre-Treatment|Four times per day dosing of vancomycin pre-treatment
15885873|NCT03759041|Drug|Placebo for Vancomycin Pre-Treatment|Four times per day dosing of placebo pre-treatment
15885874|NCT03759041|Drug|SER-287|Once-daily dosing of SER-287
15885875|NCT03759041|Drug|Placebo for SER-287|Once-daily dosing of Placebo for SER-287
15885876|NCT03759028|Drug|Ibuprofen|Post-operative pain control protocol of closed reduction percutaneous pinning of supracondylar humerus fracture.
15885877|NCT03759028|Drug|Oxycodone|Post-operative pain control protocol of closed reduction percutaneous pinning of supracondylar humerus fracture.
15885878|NCT03759028|Drug|Acetaminophen|Post-operative pain control protocol of closed reduction percutaneous pinning of supracondylar humerus fracture.
15885879|NCT03759015|Behavioral|Health education|All subjects are tasked to create an original 10-minute theater about physical activity and diet/nutrition.
15885880|NCT03759002|Diagnostic Test|Imaging|Imaging including Echocardiography for determining cardiac indices (ejection fraction, left ventricular mass index, strain rate, global longitudinal strain) and Doppler ultrasound for measuring carotid intima media thickness
15885881|NCT03759002|Other|Blood sampling|Blood sampling will performed on all participants for measuring hematological parameters including MPV.
15885882|NCT03758989|Drug|Rituximab Prednisone|A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
15885883|NCT03758989|Drug|Cyclophosphamide|A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
15885884|NCT03758989|Drug|Doxorubicin|A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
15885885|NCT03758989|Drug|Vincristine|A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
15885886|NCT03758989|Drug|Prednisone|A Phase II Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma
15885887|NCT03758976|Diagnostic Test|Biopsies, blood|We will perform targeted exon sequencing on paraffin embedded tissues from metastatic breast cancer
15885888|NCT03758963|Device|R:GEN Selective Retina Therapy|Selective Retina Therapy (SRT) is the treatment method using innovative laser technology with the wavelength absorbed by melanosomes such as laser photocoagulation, but due to short pulse width (1.7 µs) with 100 Hz repetition rate, Retinal Pigment Epithelium (RPE) cells may be destroyed only through the generation of microbubble around melanosomes (photomechanical action), and no thermal damage of normal cells or tissues may occur in the surrounding tissues. SRT influences the RPE wound healing, including migration and proliferation of RPE cells, which treats CSC in the mechanism of recovering RPE. Once RPE is recovered, the sub-retinal fluid may be pumped out and retinal function again recovered. Moreover, previous studies showed that SRT may stimulate a moderate increase of activated metalloproteinase (MMP), leading to the improvement of Bruch's membrane's transport property.
15885889|NCT03758950|Drug|Placebo|Once daily inhaled placebo for 48 weeks
15885890|NCT03758950|Drug|Mometasone|Inhaled Mometasone for 48 weeks (with 4-week washout at study completion)
15885891|NCT03758937|Procedure|volume-controlled ventilation|
15885892|NCT03758937|Procedure|pressure-controlled ventilation|
15885893|NCT03758924|Drug|ANAVEX2-73|Liquid oral solution
15885894|NCT03758924|Drug|Placebo|Liquid oral solution
15885895|NCT03758911|Other|Semi-structured Interview|
15885896|NCT03758898|Other|Treatment|Chest physiotherapy and mobilization were applied twice a day, 8 times in total.
15885897|NCT03758898|Other|Group 2|Only mobilization was applied twice a day, 8 times in total.
15885898|NCT03758885|Drug|Nolasiban|Nolasiban single oral administration
15885899|NCT03758885|Drug|Placebo|Placebo single oral administration
15885900|NCT03758872|Diagnostic Test|cuff assisted colonoscopy(with cuff use of endocuff vision second generation)|this is a cohort prospective comparative, a group without cuff in 2017, 517 patient included in the retrospective phase, and in 2018, 517 patient will be included in the prospective phase with CUFF for detecting polyps
15885901|NCT03758859|Other|sodium hyaluronate eyedrops|sodium hyaluronate eyedrops administered - route ocular -topical
15885902|NCT03758846|Behavioral|Cognitive-motor exergaming|Participants undergo 6 weeks of cognitive-motor exergaming using Wii-fit Nintendo. The 6 weeks included a total of 20 session distributed in the following manner: 5 sessions/week for 1-2 week, 3 session/week for 3-4 week, 2 sessions/week for 5-6 week. Each session lasted for about 90 minutes with rests included.
15885903|NCT03758846|Behavioral|Conventional balance Training|Participants undergo 6 weeks of conventional exercise training. The 6 weeks included a total of 20 session distributed in the following manner: 5 sessions/week for 1-2 week, 3 session/week for 3-4 week, 2 sessions/week for 5-6 week. Each session lasted for about 90 minutes with rests included.
15885964|NCT03758508|Device|Noninvasive ventilation|In this arm, participants receive noninvasive ventilation through an interface (such as full face mask or oro-nasal mask) alternated with continuous high flow oxygen though humidified nasal cannula
15885904|NCT03758846|Behavioral|Dance Therapy for Stroke|"Participants will receive therapy using the Just Dance using the commercially available Kinect gaming system (Microsoft Inc, Redmond, WA, USA. Each song involves repetitive action for each dance step (at least 20 repetitions over the entire song) and visual cues on the screen (a stick figure at the bottom right) indicating the upcoming dance step. Participant's playing the game to reduce risk of exercise related adverse effects. Participants will dance on 10 songs starting from a slow-pace progressing to a medium pace (each max 5 minutes long). Participants will receive 5 minutes rest after playing on each song. This will be conducted by two physical therapists."
15885905|NCT03758846|Behavioral|Dance Therapy for Older adults|"Participants will receive therapy using the Just Dance using the commercially available Kinect gaming system (Microsoft Inc, Redmond, WA, USA. Each song involves repetitive action for each dance step (at least 20 repetitions over the entire song) and visual cues on the screen (a stick figure at the bottom right) indicating the upcoming dance step. Participant's playing the game to reduce risk of exercise related adverse effects. Participants will dance on 10 songs starting from a slow-pace progressing to a medium pace (each max 5 minutes long). Participants will receive 5 minutes rest after playing on each song. This will be conducted by two therapists."
15885906|NCT03758846|Behavioral|Home education for Older adults|Participants will receive a one-hour education on conventional physical exercises.
15885907|NCT03758833|Diagnostic Test|preimplantation genetic test of embryo by new generation sequencing (NGS)|This is a genetic test to evaluate 24 chromosomes by the new generation sequencing platform. For that is necessary a embryo biopsy in the blastocyst stage and evaluation of a greater number of cells extracted from the trophectoderm
15885908|NCT03758833|Procedure|Single embryo transfer|Transfer of single embryo
15885909|NCT03758833|Procedure|Double embryo tranfer|Transfer of two embryos
15885910|NCT03758820|Behavioral|Behavorial Cognitive Therapy (BCT)|"Check-in : review of the homewok Talk : Presentation of the aim of the session Group Activity : Relaxation and Execises Refreshment break Homework : exercises to practice at home and explanation about the forms to fill in.
~Passout : session handbook and supports for exercises."
15885911|NCT03758807|Other|Manual Therapy with Traditional Biomechanical Explanation|Patients will lie prone and receive lumbar Posterior to Anterior (AP) Pressure with a traditional biomechanical or anatomic explanation of the technique..
15885912|NCT03758807|Other|Manual Therapy with Neuroplastiicity Explanation|Patients will lie prone and receive lumbar Posterior to Anterior (PA) Pressure with a neuroplastic explanation of the technique.
15885913|NCT03758794|Other|interactive lecture|an interactive lecture will be given to a group of dental interns students on child abuse recognition and reporting
15885914|NCT03758794|Other|online education|an online educational module will be sent to a group of dental interns students on child abuse recognition and reporting
15885915|NCT03758781|Drug|IRX 2|IRX-2 Regimen: 21 day regimen of cyclophosphamide on Day 1 and subcutaneous IRX-2 injections for 10 days between Days 4 and 18. This 21 day regimen will be given every 12 weeks.
15885916|NCT03758781|Drug|Nivolumab|Nivolumab 240 mg will be given via IV infusion once every 2 weeks.
15885917|NCT03758768|Other|Blue light exposure|Light administered through ceiling mounted light emitting diode (LED)-based room lighting.
15885918|NCT03758768|Other|Full spectrum light exposure|Light administered through ceiling mounted light emitting diode (LED)-based room lighting.
15885919|NCT03758755|Device|Blood Flow Restriction Therapy|A wide pressure cuff will be applied to the upper thigh prior to starting strengthening exercises. The cuff is inflated to 80% of resting systolic blood pressure. The cuff remains inflated for the entirety of the exercise (4 sets of a specific movement). Once the exercises are completed, it is deflated for a minimum of one minute before the next type of exercises are started.
15885920|NCT03758755|Other|ACL Reconstruction rehabilitation|post-operative rehabilitation according to current standards of care
15885921|NCT03758742|Behavioral|High-Fruit Diet|Participants will consume a diet rich in whole fruit. During Phase I (Weeks 1-4; supervised controlled feeding), participants will gradually increase the amount of whole fruit they consume, eventually reaching 50% of calories from whole fruit. In Phase II (Week 5-12; supervised controlled feeding), participants will consume a whole fruit-rich, eucaloric diet that provides 50% of calories in the form of whole fruit. The non-fruit portion of the diet will be styled as a Mediterranean Diet. Participants will be required to approximately keep their weight stable during Phases I and II. In the Follow-Up Phase (Months 4-12; free-living), participants will be instructed to continue consuming at least one-third of their diet as whole fruit and to make healthy food choices.
15885922|NCT03758729|Drug|Nivolumab|Nivolumab 3mg/kg + NS 100mL MIV over 1hr every 2 weeks
15885923|NCT03758729|Radiation|Radiation Therapy|Radiation Therapy
15885924|NCT03758716|Drug|FB825, FB825-15D11, Anti-CemX|Pharmaceutical form: 20mg/ml solution Route of administration: IV
15885925|NCT03758703|Other|Pre-recorded music intervention group|Refer to the arm/group descriptions.
15885926|NCT03758703|Other|Pre-recorded soothing poetry group|Refer to the arm/group descriptions.
15885927|NCT03758690|Device|High-Intensity Focused Electromagnetic (HIFEM) Field Device|The High-Intensity Focused Electromagnetic (HIFEM) Field device will be applied.
15885928|NCT03758677|Drug|Apatinib|30 patients who progressed after EGFR-TKI treatment without T790M mutation will receive apatinib 250mg qd orally combine with chemotherapy , if the patient has a grade 3/4 adverse reaction during such treatment, apatinib should be reduced to 250mg orally once per two days. Chemotherapeutic agents are limited to platinum-based double drugs(Pemetrexed,Gemcitabine,Docetaxel).
15885929|NCT03758664|Drug|ICP-192|"Drug: ICP-192 Dose levels will be escalated following accelerated titration and modified 3+3 dose escalation scheme,"
15885960|NCT03758521|Device|Magnetic resonance imaging (MRI)|These will be outpatient MRI studies that are planned without sedation. Subjects enrolled at BCH will undergo brain MRI, including volumetric MRI, MRS, and diffusion tensor imaging (DTI). The data will help define the natural history of brain volume, brain myelination and spectroscopic (e.g. GABA) abnormalities.
15885961|NCT03758521|Device|Electroencephalogram (EEG)|These will be outpatient EEG recordings that span 20-60 minutes and done without sedation. Recordings will be performed using electrode locations specified by the international 10-20 system for standard clinical practice.
15885962|NCT03758521|Procedure|Bio-specimen Collection|Bio-specimen collection will include blood, urine, saliva, hair, stool, and a skin biopsy. Blood, urine, saliva, blood spots, and hair samples will also be banked for to-be-determined (TBD) studies.
15885930|NCT03758638|Behavioral|Healthy Eating & Active Living Taught at Home|PAT National Center will train educators affiliated with PAT sites in HEALTH; among these, using the HEALTH training curriculum, which includes training materials, an ~8 hour training delivered through a synchronous web-based experience, and ongoing consultation. Participants at HEALTH sites receive usual care PAT+evidence-based life-style change strategies to prevent weight gain and promote weight loss embedded within and delivered as part of home visits. In addition to the usual care PAT curriculum content, goal setting related to healthy weight, and the importance of parental modeling of healthy eating and physical activity are incorporated throughout the discussion and visit. HEALTH will be delivered over 24 months via a (1) core and (2) maintenance phase. The visits begin with greater frequency, and taper. Consistent with PAT practice, the frequency and number of visits are determined by the family's needs and preferences.
15885931|NCT03758638|Behavioral|Usual Care|The Foundational (usual care) curriculum uses a strength-based, solution-focused model to provide parents with child development knowledge and parenting support, empowering parents as their child's first and most influential teacher.
15885932|NCT03758625|Biological|a1DC + inactivated whole autologous HIV|Investigational vaccine composed of autologous dendritic cells matured with an optimized cocktail (a1DC) and loaded with autologous -inactivated HIV
15885933|NCT03758625|Biological|a1DC + conserved HIV peptides|Investigational vaccine composed of autologous dendritic cells matured with an optimized cocktail (a1DC) and loaded with a conserved HIV gag and pol peptide pool
15885934|NCT03758625|Biological|a1DC + no antigen|Control vaccine composed of autologous dendritic cells matured with an optimized cocktail (a1DC) but without an antigen
15885935|NCT03758625|Biological|pgDC + inactivated whole autologous HIV|Investigational vaccine composed of autologous dendritic cells matured with a standard prostaglandin E2 cocktail (pgDC) and loaded with autologous -inactivated HIV
15885936|NCT03758625|Biological|pgDC + conserved HIV peptides|Investigational vaccine composed of autologous dendritic cells matured with a standard prostaglandin E2 cocktail (pgDC) and loaded with a conserved HIV gag and pol peptide pool
15885937|NCT03758625|Biological|pgDC + no antigen|Control vaccine composed of autologous dendritic cells matured with a standard prostaglandin E2 cocktail (pgDC) but without an antigen
15885938|NCT03758612|Drug|TBI-223 50mg|TBI-223 50 mg supplied for oral administration.
15885939|NCT03758612|Drug|Placebo for TBI-223 50mg|Matching placebo for TBI-223 50mg supplied for oral administration.
15885940|NCT03758612|Drug|TBI-223 100, 300, 600, 1200, 2000, 2600 mg|TBI-223 100, 300, 600, 1200, 2000, 2600 mg supplied for oral administration.
15885941|NCT03758612|Drug|Placebo for TBI-223 100, 300, 600, 1200, 2000, 2600 mg|Matching placebo for 100, 300, 600, 1200, 2000, 2600 mg TBI-223 supplied for oral administration.
15885942|NCT03758612|Drug|TBI-223 300 mg capsule|TBI-223 300 mg capsule supplied for oral administration
15885943|NCT03758612|Drug|Placebo for TBI-223 300 mg capsule|Placebo for TBI-223 300 mg capsule supplied for oral administration
15885944|NCT03758612|Drug|TBI-223 Prototype 1 SR Tablet|Prototype 1 TBI-223 600 mg sustained-release (SR) tablet
15885945|NCT03758612|Drug|TBI-223 Prototype 2 SR Tablet|Prototype 2 TBI-223 600 mg SR tablet
15885946|NCT03758612|Drug|TBI-223 Prototype 3 SR Tablet|Prototype 3 TBI-223 900 mg SR tablet
15885947|NCT03758612|Drug|TBI-223 IR Tablet|TBI-223 1000 mg immediate release (IR) tablet
15885948|NCT03758599|Procedure|Climbing|All interventions are identical in their duration. To fulfill the WHO guidelines of health enhancing activity (minimum 150 minutes of moderate exercise per week), two 75 minutes exercise sessions per week will take place. After meeting the inclusion criteria and after allocation to one of the three groups, patients will receive their timetable with the exercise or group session dates.
15885949|NCT03758599|Procedure|Nordic Walking|All interventions are identical in their duration. To fulfill the WHO guidelines of health enhancing activity (minimum 150 minutes of moderate exercise per week), two 75 minutes exercise sessions per week will take place. After meeting the inclusion criteria and after allocation to one of the three groups, patients will receive their timetable with the exercise or group session dates.
15885950|NCT03758599|Procedure|Social Contact|All interventions are identical in their duration. To fulfill the WHO guidelines of health enhancing activity (minimum 150 minutes of moderate exercise per week), two 75 minutes exercise sessions per week will take place. After meeting the inclusion criteria and after allocation to one of the three groups, patients will receive their timetable with the exercise or group session dates.
15885951|NCT03758586|Other|Computerized spatial skill training|The spatial skills training session consisted of six practice trials that were run in a sequence. The objective of each practice was to manipulate the simulated robotic arm to grab the cubes and move them to a desired location using keyboard keys. The participant was required to reach a decision based on the visual-spatial information, before initiating subsequent movements of the simulated robotic arm. Each practice trial presented an initial state of the cubes in front of the robotic arm, and a target position of the cubes.
15885952|NCT03758586|Other|Watching a presentation regarding robotic surgery|Watching a 20-35 minute long power-point presentation regarding the history of robotic surgery.
15885953|NCT03758573|Other|Inspiratory Muscle Training (IMT)|Inspiratory Muscle Training (IMT)
15885954|NCT03758573|Other|Intensive Physiotherapy (IPT)|Intensive Physiotherapy (IPT)
15885955|NCT03758560|Other|Pre-operative Nepali version of pain catastrophizing scale (PCS) questionnaire|Patients will be asked to complete the scores based Nepali version of pain catastrophizing scale (PCS) questionnaire preoperatively
15885956|NCT03758547|Device|in-exufflator technique|application through a device of 10 cycles using positive pressure (30 cmH20) during inspiration and negative pressure (-30 cmH20) during exhalation
15885957|NCT03758547|Device|percussion technique|sliding venturi system (phasitron), powered by compressed gas that can be changed from 0.8 up to 3.5 bar and that generates the oscillations in the range of 80-650 cycles/min
15885958|NCT03758534|Other|No intervention|This is a retrospective chart review study.
15885959|NCT03758521|Device|Transcranial magnetic stimulation (TMS)|Transcranial magnetic stimulation (TMS) is a method for noninvasive electrical cortical stimulation, where small intracranial currents are generated by a powerful, fluctuating, extracranial magnetic field. TMS is unique in its capacity for experimental, diagnostic, and therapeutic utility. Single pulse (spTMS) and paired-pulse TMS (ppTMS) have been used extensively to study, measure, and modulate cortical excitability and plasticity.
15885965|NCT03758495|Other|Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)|The investigators will use these techniques combined with attention tests, memory tests, and clinical interviews to explore connections between these measures and activity in the brain in patients with a diagnosis of schizophrenia, major depressive disorder, and healthy controls.
15885966|NCT03758482|Other|Probe meal|The probe meal (total caloric content 750 Kcal) will be ingested at a standard rate in 10 min.
15885967|NCT03758469|Drug|HSK3486|Sequence 1: Intravenously infuse 0.4 mg/kg HSK3486 in the morning on an empty stomach. Complete infusion within 1 min.
15885968|NCT03758469|Drug|rifampin , HSK3486|Sequence 2: Orally take 600 mg rifampin once a day for 8 consecutive days in the morning on an empty stomach, followed by 1 min intravenous infusion of 0.4 mg/kg HSK3486 30 min later.
15885969|NCT03758456|Biological|HAL-MRE1|HAL-MRE1 is a liquid suspension for subcutaneous administration containing aluminum hydroxide adsorbed modified allergens extracted from ragweed pollen.
15885970|NCT03758443|Drug|TD-1473 Dose A|See Arm description
15885971|NCT03758443|Drug|TD-1473 Dose B|See Arm description
15885972|NCT03758443|Drug|TD-1473 Dose C|See Arm description
15885973|NCT03758443|Drug|Placebo|See Arm description
15885974|NCT03758430|Other|Meal-Tagging App|Meal tagging app to capture frequently eaten meals and test meals for 16 weeks.
15885975|NCT03758430|Device|Fitness Tracker|Fitness tracker will be worn around the clock for 16 weeks.
15885976|NCT03758417|Biological|LCAR-B38M CAR-T Cell|Participants will receive LCAR-B38M CAR-T cells as a single infusion which consists of autologous T lymphocytes transduced with LCAR-B38M, a lentiviral vector to express a chimeric antigen receptor targeting the human B cell maturation antigen (anti-BCMA CAR).
15885977|NCT03758404|Biological|AAV- CNGA3|AAV gene therapy for defects in CNGA3 gene
15885978|NCT03758391|Other|Flipped Classroom education|Fellows will receive GI/Bilirubin education in a flipped classroom format.
15885979|NCT03758378|Other|Dietary intervention|Limiting dietary exposure to high intensity sweeteners and sugar alcohols; limiting eating out to a maximum of 2 days per week.
15885980|NCT03758365|Drug|MC2-01 Cream|Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
15885981|NCT03758365|Drug|Clobetasol Propionate 0.05% Lotion|Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
15885982|NCT03758365|Drug|Betamethasone Dipropionate 0.05% Cream|Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
15885983|NCT03758365|Drug|Triamcinolone Acetonide 0.1% Cream|Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
15885984|NCT03758365|Drug|Hydrocortisone Butyrate 0.1% Cream|Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
15885985|NCT03758365|Drug|Desonide 0.05% Cream|Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
15885986|NCT03758365|Drug|Vehicle|Single application, visual evaluation of skin blanching and local tolerability, physical examination and safety evaluation
15885987|NCT03758352|Procedure|remote ischemic preconditioning (rIC)|Short intermittent peripheral occlusions and reperfusions of the blood flow in the right lower extremity with the help of a tourniquet.
15885988|NCT03758352|Other|non remote ischemic preconditioning (non-rIC)|Retrospective group who have not undergone intervention.
15885989|NCT03758339|Drug|tucatinib|Single dose of 300 mg of [¹⁴C]-tucatinib containing approximately 150 μCi of [¹⁴C] radioactivity
15885990|NCT03758326|Other|Body App|Participants will indicate areas of concern on a virtual manikin using an electronic online interface. Body measurements will also be collected.
15885991|NCT03758313|Other|CO2 measurements|Distal etCO2, tcCO2 and paCO2 values will be recorded simultaneously in ventilated preterm infants. We will measure etCO2 in a distal position using a double lumen tube connected to an external side-stream capnometer.
15885992|NCT03758300|Other|Radiofrequency|See previous page
15885993|NCT03758287|Drug|CT053PTSA|
15885994|NCT03758287|Drug|Gefitinib|
15885997|NCT03758261|Drug|Paravertebral nerve block|The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound Paravertebral Nerve Block will be performed.
15885998|NCT03758261|Drug|Erector Spinae nerve block|The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound erector spinae nerve block will be performed.
15885999|NCT03758248|Genetic|CYP2C19|The CYP2C19 enzyme plays a vital role in the two bioactivation steps of clopidogrel leading to lower (CYP2C19*17 carriers) or higher (CYP2C19*2 carriers) risk of major adverse cardiovascular events.
15886000|NCT03758235|Drug|IncobotulinumtoxinA 100 UNT Injection [Xeomin]|Incobot/A intradetrusor injections under cystscopic guidance, with local anaethesia in an outpatient basis
15886001|NCT03758235|Drug|OnabotulinumtoxinA 100 UNT [Botox]|Onabot/A intradetrusor injections under cystscopic guidance, with local anaethesia in an outpatient basis
15886002|NCT03758222|Device|XFLO Expander System|Implantation and retrieval of the XFLO Expander System in the prostatic urethra to treat benign prostatic hyperplasia (BPH)
15886003|NCT03758209|Procedure|Prehabilitation + ERAS|Prehabilitation will cover a range preoperative education and exercises (weekly) on diet, physical activity (daily walking), respiratory training (forced deep inspiration with spirometer device), as well as anxiolytic group psychotherapy.
15886004|NCT03758209|Procedure|ERAS|Enhanced Recovery Program, including preoperative 4 weeks nutritional supplementation.
15886005|NCT03758196|Device|Radiofrequency ablation instruments|Renal Sympathetic Denervation from the adventitia of renal artery
15886006|NCT03758183|Procedure|total knee arthroplasty|
15886008|NCT03758157|Diagnostic Test|welloStationX|welloStationX is an automated electronic thermometer using an infrared sensor of the surface of the forehead to measure human body skin temperature to screen for fever.
15886009|NCT03758157|Diagnostic Test|SureTemp|SureTemp is an oral thermometer to measure human body skin temperature.
15886010|NCT03758144|Drug|Rifaximin 200 MG|patients with type 2 diabetes and gut dysbiosis will be given rifaximin
15886011|NCT03758131|Behavioral|Peer-enhanced Motivational Interviewing|"In the Peer-Enhanced Motivational Interviewing (PMI) condition, target clients and peers will receive separate one-hour sessions of Motivational Interviewing (MI), an empirically-supported treatment that helps individuals work through ambivalence about making changes in substance use. MI is thought to work because it is a non-confrontational intervention where a therapist empathetically reviews substance use behaviors, listens empathetically, and reinforces any client statements indicating a desire to change. With the peer of each PMI dyad, the therapist presents peer with data about the extent of the target client's substance use, builds the peer's motivation to help their friend, and teaches the peer communication skills they can use to influence the target client's substance use."
15886012|NCT03758131|Behavioral|Motivational Interviewing|In the Motivational Interviewing (PMI) condition, target clients only will receive one-hour sessions of Motivational Interviewing (MI), an empirically-supported treatment that helps individuals work through ambivalence about making changes in substance use. MI is thought to work because it is a non-confrontational intervention where a therapist empathetically reviews substance use behaviors, listens empathetically, and reinforces any client statements indicating a desire to change.
15886013|NCT03758131|Other|Waitlist Control|Dyads randomized to this intervention will have no contact with study personnel until 2 months after the PMI group has completed the PMI intervention. Then those in the Waitlist Control condition will receive the full PMI protocol.
15886014|NCT03758118|Dietary Supplement|Citicoline|Citicoline administered in oral solution
15886015|NCT03758105|Other|tDCS associated with usual care|"A tDCS cure will be given to the group tDCS, one week after their randomization.
~This will be done in association with usual care: medication and psychotherapy Parameters: Anodal stimulation on dorso-lateral prefrontal cortex left, 2mA current.
~Treatment will consist of 15 days with 30 minutes stimulation per day, 5 days a week for 3 weeks."
15886016|NCT03758105|Other|Usual care|Medication and psychotherapy as prescribed in usual care
15886017|NCT03758079|Drug|Doxepin|10 mg Doxepin for 4 weeks
15886018|NCT03758079|Drug|Gabapentin|dose of 100mg after each hemodialysis session (increased as tolerated) for 4 weeks
15886019|NCT03758066|Device|PlusCare|PlusCare is a mobile application designed to be used by youth and young adults with HIV and case managers.
15886020|NCT03758053|Other|No intervention|No intervention
15886021|NCT03758040|Other|Slips on Turns|Subjects will be administered a slip at 3 different times in the gait cycle for each of 3 different patch curvatures and 2 different legs for a total of 18 slip episodes. Slips will be delivered while walking along a straight path (infinite radius), or curved paths with radii 2, or 1 meters.
15886022|NCT03758040|Other|Slips on Slopes|Slips will be administered at 3 different times in the gait cycle over sloped ground surface of no slope, ±5.0 and ±10.0 degrees slopes in the direction of walking, and 5.0 and 10.0 degrees perpendicular to the direction of walking. On slopes perpendicular to the direction of walking, slips will be administered to the uphill or downhill foot. A total of 27 slip episodes will be administered. Sloped walking surfaces will be generated with the CAREN system treadmill.
15886023|NCT03758027|Behavioral|CARESS|"The goals of each component are as follows:
~Communicate alternatively - a method to bring the brain back and remove the individual from his/her limbic system;
~Release endorphins - a release for the internal stress created by the emotion; and
~Self-soothe - a method of quelling and containing."
15886024|NCT03758027|Behavioral|Isometric Exercise|5-minute protocol for cravings management and affect regulation
15886025|NCT03758014|Drug|Chlorogenic acid for Injection|Chlorogenic acid (CHA) is a class 1 innovative small molecular natural drug, developed by Sichuan Jiuzhang Biological Science and Technology Co., Ltd. The mechanism of broad-spectrum antitumor activity is immunoregulation.
15886026|NCT03758014|Drug|Lomustine|Lomustine (INN), abbreviated as CCNU (original brand name (formerly available) is CeeNU, now marketed as Gleostine), is an alkylating nitrosourea compound used in chemotherapy. It is closely related to semustine and is in the same family as streptozotocin. It is a highly lipid-soluble drug, thus it crosses the blood-brain barrier. This property makes it ideal for treating brain tumors, which is its primary use.
15886027|NCT03758001|Drug|IBI101|0.01 mg/kg; 0.1 mg/kg; 0.3 mg/kg; 1 mg/kg; 3 mg/kg; 6 mg/kg; 10 mg/kg; 15 mg/kg iv infusion day 1 of every 21 days
15886028|NCT03758001|Drug|IBI101|1 mg/kg; 3 mg/kg; 6 mg/kg; 10 mg/kg iv infusion day 1 of every 21 days
15886029|NCT03758001|Drug|Sintilimab|200mg iv infusion day 1 of every 21 days
15886030|NCT03757988|Behavioral|Exercise Intervention- PACE-Life|Subjects will be provided with a Fitbit wristband and instructed how to use it. During the first group session, subjects will be taught how to use their heart rate (on the Fitbit) to determine how fast subjects should walk (to achieve the appropriate exercise dosage). Information on proper care, usage, and how to determine the appropriate heart rate from the watch, which will be used to guide the intensity of the walk will be provided to subjects and reviewed at each group session. For all clinic based group sessions, subjects will arrive at the STEP clinic to meet the entire group and leaders and be reminded of the HR that corresponds with the intensity of that group session. Next, the group will go outside and walk for 30 minutes.
15886031|NCT03757975|Procedure|urethral length measure|measure of urethral length, distribution of questionnaires before and after operation
15886032|NCT03757962|Other|Dietary intervention|Limiting dietary exposure to benzoic acid, sorbic acid, polysorbates and related food additives; limiting eating out to a maximum of 2 days per week.
15886033|NCT03757949|Other|Laboratory Biomarker Analysis|Correlative studies
15886034|NCT03757949|Dietary Supplement|Nutritional Intervention|Receive SIM PO
15886035|NCT03757949|Other|Placebo Administration|Given PO
15886036|NCT03757949|Other|Quality-of-Life Assessment|Ancillary studies
15886037|NCT03757949|Other|Questionnaire Administration|Ancillary studies
15886038|NCT03757936|Drug|HLX04|Recombinant Anti-VEGF Humanized Monoclonal Antibody Injection
15886039|NCT03757936|Drug|HLX10|Recombinant Anti-PD-1 Humanized Monoclonal Antibody Injection
15886044|NCT03757897|Drug|Dexmedetomidine|The standard dosing of 1mcg/kg will be implemented over 10 minutes followed by a maintenance infusion of 0.2-1.0 titrated to a the target BIS (60-70) during the 20 minutes prior to MRI.
15886045|NCT03757884|Behavioral|Mindfulness breathing exercise|Spire monitor instructed mindfulness breathing
15886046|NCT03757884|Behavioral|Diagnostic Checklist|Checklist reminder for diagnosis
15886047|NCT03757884|Behavioral|Noise cancelling headphones|Noise cancelling headphones
15886048|NCT03757884|Behavioral|Privacy tablescreen|Privacy Tablescreen
15886049|NCT03757884|Behavioral|Diagnostic assistance application|Diagnostic assistance application
15886050|NCT03757871|Device|Laser stimulation|an acupuncture or placebo session will be performed 30 minutes before the fundus examination. This session will last 5 minutes.
15886051|NCT03757858|Device|Thermotron RF-8|Hyperthermia for 40 minutes, with maximum temperature setted on 42℃ ± 0.5℃ as upper limit, twice a week for a total of 10 times.
15886052|NCT03757858|Biological|Adoptive cellular Immunotherapy|Mononuclear cells were collected from 50ml peripheral blood , and cultured cytokine-induced killer cells for 15-20 days. Cells were infused back to the patients in 3 times via intravenous infusion .Patients will received at least 2 cycles of CIK Immunotherapy . If the evaluation of the treatment is complete response, partial response or stable disease, additional cycles were eligible.
15886053|NCT03757858|Drug|Anti-PD-1 antibody|Patients will receive pembrolizumab 100mg every three weeks and assess the clinical outcome every 2 dosage of anti-PD-1 antibody treatment.
15886054|NCT03757858|Drug|Chemotherapy|Patients will receive standard chemotherapy until disease progression, unacceptable toxicity or patient refusal.
15886055|NCT03757845|Other|Mediterranean Diet|subjects will be asked to eat from a sub-menu items compliant with Mediterranean Diet
15886056|NCT03757832|Device|Liver Imaging|The device will acquire thermoacoustic data while the ultrasound probe acquires ultrasound images, and an MR of the liver is acquired as a comparative modality.
15886057|NCT03757819|Device|tDCS|Brain Stimulation
15886058|NCT03757819|Device|SHAM|Placebo device
15886059|NCT03757806|Other|Experimental group|"LiFE4D is an individualised programme, adapted to the participant's needs/preferences.
~People with Dementia will receive assistance to increase their physical activity multiple times/day in their everyday tasks with the support/supervision of their caregivers.
~The programme last for 12 weeks, with a lower face tracking over time with the health professional but replaced by caregivers. The intervention includes face-to-face sessions and phone calls. Face-to-face sessions aim to adapt physical activity to everyday tasks, increase tasks frequency and intensity, monitor progress, clarify doubts, motivate and manage expectations. Phone calls aim to monitor motivation/evolution and clarify doubts."
15886060|NCT03757793|Device|FORE-SIGHT ELITE monitor|At end of surgery, one sensor of the FORE-SIGHT Elite monitor is placed on the DIEP flap or two sensors in case of bilateral DIEP flaps for monitoring perfusion and oxygen consumption in the free flap. A control sensor of the FORE-SIGHT Elite monitor placed on the abdomen where tissue is taken to perform the DIEP flap. This sensor reflects normal tissue oxygenation. Data obtained from the FORE-SIGHT Elite monitor will be compared to data obtained from physical examination, which is standard of care for flap monitoring.
15886061|NCT03757780|Other|Questionaire|A questionaire will be made to pregnant ladies who take caffeine during pregnancy
15886062|NCT03757767|Other|Fasting for 26-hours|"All research subjects will have to fast for 26 hours in total.
~All research subjects start with a standardized meal. Two hours after the standardized meal the samples in the fed state will be taken. Research participants are not allowed to eat anything after the consumption of the standardized meal until the second measurements on day 2, 26-hours later. There are 24 hours between the two measurement points."
15886063|NCT03757754|Drug|HPPH 2.5 mg/m2|HPPH was administered as a single, 2.5 mg/m2, slow intravenous infusion over 1 hour , and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.
15886064|NCT03757754|Drug|HPPH 3 mg/m2|HPPH was administered as a single, 3 mg/m2, slow intravenous infusion over 1 hour, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.
15886065|NCT03757754|Drug|HPPH 3.5 mg/m2|HPPH was administered as a single, 3.5 mg/m2, slow intravenous infusion over 1 hour, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.
15886066|NCT03757754|Drug|HPPH 4 mg/m2|HPPH was administered as a single, 4 mg/m2, slow intravenous infusion over 1 hour, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.
15886067|NCT03757754|Drug|HPPH 5 mg/m2|HPPH was administered as a single, 5 mg/m2, slow intravenous infusion over 1 hour, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.
15886068|NCT03757754|Drug|HPPH 6 mg/m2|HPPH was administered as a single, 6 mg/m2, slow intravenous infusion over 1 hour, and a fixed light dose of 150 J/cm delivered 48 hours after infusion of HPPH.
15886069|NCT03757741|Diagnostic Test|Cardiac imaging tests|2D transthoracic echocardiography; Late gadolinium-enhancement cardiac magnetic resonance with the evaluation of pulmonary veins anatomy, atrial fibrosis, atrial volumes and the amount of epicardial fat will
15886070|NCT03757741|Diagnostic Test|Venous blood samle collection|Venous blood sample collection 1 day prior to the ablation procedure: Serum levels of high sensitive C Reactive Protein, Matrix metalloproteases, Interleukin-6, and N-Terminal Pro-B-Type Natriuretic Peptide.
15886071|NCT03757728|Procedure|Haemorrhoidectomy operations|for treatment of symptomatic 2 to 3 degree haemorrhoids
15886072|NCT03757715|Drug|Bupivacaine|20 mL of 1.3% bupivacaine
15886073|NCT03757715|Drug|Dexamethasone|2 mg dexamethasone
15886074|NCT03757702|Other|Evaluation|Trunk position sense will be evaluated with a digital inclinometer. Trunk reposition test will be used in evaluation.The postural stability will be evaluated with a special balance device in eyes opened and closed position. Ellipse area (mm2) and perimeter (mm) parameters will be recorded.The angles of thoracal kyphosis and lumbar lordosis will be evaluated with a digital inclinometer.
15886075|NCT03757689|Drug|Pembrolizumab|Pre-Surgery: Pembrolizumab, one 200mg dose; Post-Surgery: Pembrolizumab, 200 mg every 3 weeks.
15886076|NCT03757689|Procedure|Wide Excision and Sentinel Lymph Node (SLN) Biopsy|Wide excision and SLN biopsy and pathologic assessment of tissue will be performed per standard of care.
15886186|NCT03756896|Drug|Pomalidomide|Given PO
15886187|NCT03756883|Drug|Fluticasone Propionate and Salmeterol Inhalation Powder|100/50 mcg per actuation
15886447|NCT03755011|Behavioral|usual care|normal ICU activity noise
15886077|NCT03757676|Behavioral|No Play|Participants in this group were asked not to download or play Pokémon Go during the study period and were asked to simply continue with their normal daily activities. Participants were asked to wear the Fitbit device and use the GPS app on their mobile phones during the 6-week study period. Starting the fifth week, participants were prompted to complete five (5) brief daily surveys on their phones via the EMA app.
15886078|NCT03757676|Behavioral|At Will Play|Participants in this group were asked to download Pokémon Go and play for at least 30 minutes initially, then play as much or as little as desired during the 4 week intervention period, with no specific instruction or goals for play. Participants were asked to wear the Fitbit device and use the GPS app on their mobile phones during the 6-week study period. Starting the fifth week, participants were prompted to complete five (5) brief daily surveys on their phones via the EMA app.
15886079|NCT03757676|Behavioral|Goal Oriented Play|Participants in this group were asked to download and play Pokémon Go and achieve a minimum player level of 20 within the game during the study period. They were given materials that described game features and functions to show them how to play the game. There were no restrictions on which features to pursue within the game to achieve this goal nor on how long or how frequent their play sessions should be. Upon reaching their goal (Level 20), participants were encouraged to continue to play as much or as little as they desired. Participants were asked to wear the Fitbit device and use the GPS app on their mobile phones during the 6-week study period. Starting the fifth week, participants were prompted to complete five (5) brief daily surveys on their phones via the EMA app.
15886080|NCT03757663|Behavioral|UV Counseling|Participants will self-report their knowledge and attitudes related to UV exposure. They will then wear a dosimeter for 3 weeks. After, the study team will counsel the participants on their UV levels and exposure, creating a personal plan and advice for avoiding sun exposure before letting the participants wear the dosimeter for an additional 3 weeks.
15886081|NCT03757650|Drug|Bismuth Subsalicylate|omeprazole 2x1) + clarithromycin 2x500 mg + amoxicilline 2x1000 mg + Bismuth Subsalicylate 2x1
15886082|NCT03757637|Other|NLSCP|Phase II is a 6-month three-group randomized controlled trial with 12 month follow-up of its effects. In addition to receive hospital routine case manager care, patients in this groups will further receive either NLSCP (Exp-1). Patients will be provided the same major education and counseling contents for the first two section of interventions through face-by-face by trained research nurses at time of (1) first intervention: one day before hospital discharge in post-operation, and (2) second intervention: first OPD visit (first week after hospital discharge). This group will receive a face-to-face education or counseling by trained research nurse.
15886083|NCT03757637|Other|ICT supported HAP|Phase II is a 6-month three-group randomized controlled trial with 12 month follow-up of its effects. In addition to receive hospital routine case manager care, patients in the groups will further receive ICT supported HAP (Exp-2) intervention. For this groups, patients will be provided the same major education and counseling contents for the first two section of interventions through face-by-face by trained research nurses at time of (1) first intervention: one day before hospital discharge in post-operation, and (2) second intervention: first OPD visit (first week after hospital discharge). The group will receive the interactive mobile phone App.
15886084|NCT03757624|Procedure|shrinkage|shrinkage of gastric specimen in %10 formol solution after Laparoscopic Sleeve Gastrectomy
15886085|NCT03757611|Dietary Supplement|Tabetri capsule|1,000 mg/capsule (Taheebo extract 600 mg/day)
15886086|NCT03757611|Dietary Supplement|Placebo capsule|1,000 mg/capsule
15886087|NCT03757598|Other|ePartogram use|Electronic partograph based on WHO standard paper partograph is given in Android tablet used by provider monitoring clients in labor. Providers had received training in using the ePartogram and ongoing trouble shooting.
15886088|NCT03757585|Drug|Open-label Treatment with Omega-3 Fatty Acids + Inositol|Open-label Treatment with Omega-3 Fatty Acids + Inositol
15886089|NCT03757585|Drug|Open-label Treatment with N-acetylcysteine|Open-label Treatment with acetylcysteine
15886090|NCT03757572|Other|Alginate dressings|"The pilonidal cyst will be resected, with the use of a scalpel and then haemostasis will be performed with diathermy. Alginate dressings with silver and high-G cellulose will be applied to the wound. The size of the dressings will be 3cm X 45cm and 1 cm cord will be used for filling the wound cavity. Dressings with perimetric adhesive layer from natural materials, will be also placed.
~During wound care the wound will be irrigated with normal saline and betadine solution and finally without pressure the trauma will be dried."
15886091|NCT03757572|Other|Simple gauze dressings|"The pilonidal cyst will be resected, with the use of a scalpel and then haemostasis will be performed with diathermy. Simple gauze dressings will be applied to the wound.
~During wound care the wound will be irrigated with normal saline and betadine solution and finally without pressure the trauma will be dried."
15886092|NCT03757559|Drug|Cebranopadol 100 micrograms|Tablets were taken under fasted conditions with non-carbonated water.
15886093|NCT03757559|Drug|Cebranopadol 400 micrograms|Tablets were taken under fasted conditions with non-carbonated water.
15886094|NCT03757559|Drug|Hydromorphone hydrochloride 4 milligrams|Over-encapsulated immediate-release tablets were taken under fasted conditions with non-carbonated water.
15886095|NCT03757559|Drug|Placebo matching hydromorphone|Placebo matching over-encapsulated hydromorphone tablets were taken under fasted conditions with non-carbonated water.
15886096|NCT03757559|Drug|Placebo matching cebranopadol|Placebo matching cebranopadol tablets were taken under fasted conditions with non-carbonated water.
15886097|NCT03757546|Other|observational|The aim of the study is to describe extra-pulmonary complications due to influenza virus and RSV in hospitalized patients from November 2018 to April 2019 and November 2019 to April 2020 in a French university hospital.
15886098|NCT03757533|Behavioral|Health Coaching|10 phone calls with a trained health coach
15886099|NCT03757533|Other|Surveys|Surveys to assess Behavioural and Psychosocial measures
15886100|NCT03757520|Diagnostic Test|Pain Pressure Threshold|The pain pressure thresholds (PPTs) will be measured using an pressure algometer commander over potential trigger points (TrPs) on the body for upper fiber of trapezius, and sternocleidomastoid muscle.
15886101|NCT03757520|Diagnostic Test|Hand Grip Force|"For measuring the grip strength, the subjects will be asked to sit on a chair with their hip joint flexed at 90 degree, and shoulder joint in a neutral position.
~The elbow is fixed at 90 degree flexion, forearm in a neutral position, and wrist at 0 to 15 degree radial deviation The test will be performed twice, and the higher value between the two measurements will be selected."
15886102|NCT03757507|Device|MultiSpectral Optoacoustic Tomography|Multispectral Optoacoustic Tomography is a new emerging imaging technique which uses laser light to heat up molecules with a high pulsed laser. The molecules undergo thermal expansion and produces sound waves, which can be detected by special transducers. The device can pick up different signals in different wavelength to produce images with anatomic and biological information.
15886103|NCT03757494|Device|Alpha Stim|Use of Alpha Stim Device
15886104|NCT03757481|Other|no intervention|SF-36 questionnaire , PembQoL, Villalta score ,PembQoL
15886105|NCT03757468|Device|orthodontic - maxillary expansion|After appliance placement, the screw (hyrax or leaf type) will be activated until overcorrection. Expansion will be considered adequate when the occlusal surface of the first maxillary palatal cusp contact the occlusal surface of the mandibular first molar facial cusp. When will be achieved, the expander will stay in place for 10 months.
15886106|NCT03757455|Procedure|ERAS protocol preoperative actions|"First appointment:
~- Enlightenment on the benefits and objectives of the ERAS protocol
~Call to the patient day before the surgery:
~Discussing the course, benefits and goals of care in ERAS 4 dl PreOp drink before bedtime
~Operation day:
~Fluid intake allowed 2 hours before surgery 2 dl PreOP drink 2 h before cutting"
15886107|NCT03757455|Procedure|ERAS protocol intraoperative actions|"Intraoperative:
~Drains in the peripancreatic or perihepatic regions are not set unless the surgeon sees this particular reason The nasogastric tube is removed at the end of the surgery"
15886108|NCT03757455|Procedure|ERAS protocol postoperative actions|"Postoperatively:
~Mobilization with nurses assisted Drinks allowed after 4h surgery
~POP 1:
~Drinking and normal food Removal of urinary catheter Intravenous liquids only if needed Mobilization Pain management by epidural cannula Discussion of the ERAS protocol Pancreatin capsules per os before eating
~Postoperative day 2:
~- Mobilization: As much as possible, autonomous movement
~Postoperative day 3:
~Ending epidural infusion cannula removal Mobilization as independently as possible
~Pain relief: oxycodone/naloxone p.o. to keep mobilization possible:
~Postoperative day 4:
~Support and encouragement continues Pain management at a level that allows mobility"
15886109|NCT03757429|Other|RS-virus infection|The intervention consists of lower respiratory tract infection due to RS-virus
15886110|NCT03757416|Other|Data collection|If it has been determined that the patient will be undergoing flexor tenosynovectomy for the treatment of recurrent carpal tunnel syndrome, the patient will be asked to participate in this data collection study.
15886111|NCT03757403|Drug|RDD1609|RDD1609 to be applied on the perianal area BID
15886112|NCT03757403|Drug|Mebendazole 100 MG|Mebendazole 100 mg single dose (single prophylactic dose of the anthelmintic medicine)
15886113|NCT03757390|Drug|Exforge® tab 5/160mg, Crestor® tab 10mg|co-administration of Amlodipine 5mg/Valsartan 160mg(combination drug) and Rosuvastation 10mg
15886114|NCT03757390|Drug|CJ-30060 5/160/10mg|Fixed-dose combination drug containing Amlodipine 5mg and Valsartan 160mg and Rosuvastatin 10mg
15886115|NCT03757377|Device|BackBeat Moderato System|Eligible patients randomized after optimization phase to PHC ON for 12 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator
15886116|NCT03757377|Device|BackBeat Moderato Sytsem|Eligible patients randomized after optimization phase to PHC OFF for 12 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator.
15886117|NCT03757364|Drug|Methotrexate|Methotrexate in the treatment of distal interphalangeal joint extensor tendon enthesopathy in patients with nail psoriasis
15886118|NCT03757351|Drug|DNL747|Repeating oral dose
15886119|NCT03757351|Drug|Placebo|Repeating oral dose
15886120|NCT03757338|Drug|Fingolimod Reference Formulation|To compare the rate and extent of absorption for Fingolimod when administered as a single oral dose of 3 x 0.5 mg capsules of the reference product produced by Novartis Pharmaceutical with the proposed test product manufactured by Asofarma S.A.I. y C. in healthy volunteers, under fasted conditions.
15886121|NCT03757338|Drug|Fingolimod Test Formulation|To compare the rate and extent of absorption for Fingolimod when administered as a single oral dose of 3 x 0.5 mg capsules of the proposed test product manufactured by Asofarma S.A.I. y C. with the reference product produced by Novartis Pharmaceutical in healthy volunteers, under fasted conditions.
15886122|NCT03757325|Drug|DNL747|DNL747
15886123|NCT03757325|Drug|Placebo|Placebo
15886124|NCT03757312|Diagnostic Test|Ultrasound|Ocular ultrasound to measure optic nerve sheath diameter (ONSD).
15886125|NCT03757299|Diagnostic Test|HPV Test|Vaginal specimens for HPV test will be collected by participants themselves using flocked swabs after explanations by co-investigators. Two transport mediums will be used for those self-collected vaginal samples: NaCl 0.9%.
15886126|NCT03757286|Procedure|FSF with CAD\CAM customized cutting guide|"This began with the acquisition of a high-resolution CT scan of the patient's maxilla and scapula. The CT scan will be sent to the modeling company that produce 3D autoclavable models and cutting guides to be used during resection and scapular harvesting as well as a model of the final reconstructed maxilla.
~surgery will performed by two surgical teams one for tumor resection and the other harvesting the flap.
~access to the maxilla was obtained and the cutting guides were secured in the planned position; the cuts were completed. The scapular guides were secured to the harvested scapula to replicate the cuts that were planned previously.
~The scapula and plate will be fixed and pedicle anastomosis is performed. the operation then completed with soft tissue reconstruction."
15886127|NCT03757286|Procedure|FSF without customized cutting guide|"This began with the acquisition of a high-resolution CT scan of the patient's maxilla .
~The C.T scan will be sent to the modeling company for planning three-dimensional model of the maxilla. autoclavable model will be prepared to be used during the workflow for plate reshaping to conforme the prices position of the maxilla.
~surgery will performed in a single step by two surgical teams, one for cervicofacial resection and the other for harvesting the flap.
~Resection-reconstruction then performed in aconventional surgical manner with microvascular anastomosis. finally the operation will be completed with soft tissue reconstruction as needed."
15886188|NCT03756883|Drug|Fluticasone Propionate and Salmeterol Inhalation Powder|100/50 mcg per actuation
15886189|NCT03756883|Drug|Placebo Inhalation Powder|No active content
15886190|NCT03756870|Procedure|Percutaneous coronary intervention (PCI)|A percutaneous coronary intervention of the chronic total occlusion with a drug-eluting stent.
15886191|NCT03756857|Procedure|Afterload Transfer|"Embryo transfer is done by using afterload transfer method"
15886128|NCT03757273|Procedure|FFF with CAD/CAM customized cutting guide|This began with the acquisition of a high-resolution CT scan of the craniofacial skeleton and lower legs. the CT scan will be sent to the modeling company for producing autoclavable 3D models and cutting guides of the mandible and fibula to be used during the workflow as well as a model of the final reconstructed mandible. Surgery will be performed by two surgical teams, one for cervicofacial resection and the other harvesting the flap. access to the mandible is obtained, osteotomy guides secured; cuts then accomplished as planned virtually. fibular flap is harvested and cutting guides secured to replicate osteotomies and reshaping as planned to conform with remaining mandible. fixation and pedicle anastomosis is performed. Finally, the operation completed with soft tissue reconstruction.
15886129|NCT03757273|Procedure|FFF without customized cutting guide|"This began with the acquisition of a high-resolution CT scan of the craniofacial skeleton. the C.T scan will be sent to the modeling company for planning three-dimensional model of the mandible. autoclavable model will be prepared for mandible to be used during the workflow for plate reshaping and positioning to conform with the remaining mandible.
~Surgery will be performed by two surgical teams, one in charge of cervicofacial resection and the other harvesting the flap. access to the mandible is obtained, and resection/ reconstruction then performed in conventional surgical manner with microvascular anastomosis. Finally, the operation will be completed with soft tissue reconstruction."
15886130|NCT03757260|Device|Antimicrobial photodynamic therapy|Antimicrobial photodynamic therapy is carried out in the residual pockets using the Periowave system. The photosensitizing agent is methylene blue. Approximately 0.2 mL of the solution is applied over 60 seconds to each pocket with a blunt-ended side-port irrigator. The site is illuminated for 60 seconds to activate the agent using a disposable, light-diffusing tip that is introduced into the pocket via a diode laser (wavelength = 675 nm, 160 mW of output power).
15886131|NCT03757260|Device|Placebo of photodynamic therapy|The placebo of the antimicrobial photodynamic therapy is carried out in the residual pockets using the Periowave system. The photosensitizing agent is saline solution. Approximately 0.2 mL of the solution is applied over 60 seconds to each pocket with a blunt-ended side-port irrigator. The site is not illuminated (falsely activated) for 60 seconds using a disposable, light-diffusing tip that is introduced into the pocket via a diode laser (wavelength = 675 nm, 160 mW of output power).
15886132|NCT03757234|Drug|Omadacycline|po tablets
15886133|NCT03757234|Drug|Levofloxacin|iv solution/po tablets
15886134|NCT03757234|Drug|Omadacycline|iv solution
15886135|NCT03757221|Combination Product|Ixazomib and Daratumumab|"Daratumumab will be administrated every week for the first 2 cycles. For cycle 3 to 6, it will be administrated every two weeks at day 1 and day 15. From cycle 7 until progression Daratumumab will be administrated every 4 weeks.
~Ixazomib will be administrated every week three weeks on one week off at D1, D8 and D15 on a 28-d cycle basis.
~Dexamethasone will not be given except one series of 4 days of dexamethasone, 20 mg/day or a maximum of 80 mg, for emergencies and complications at initiation of treatment."
15886136|NCT03757208|Dietary Supplement|carbohydrate rich drink|The carbohydrate rich drink (CHD) group received oral carbohydrate (200 ml) 2-3 h before surgery,
15886137|NCT03757195|Procedure|Augmentation|combination product
15886138|NCT03757182|Other|Wearable activity monitor|Continuous monitoring of physical activity including step counts, sleep, heart rate, with consumer-based wearable activity monitor (Fitbit Charge HR)
15886139|NCT03757169|Other|Hand grip isometric contraction|The patients at the Hand Grip group will perform 12 weeks of hand grip exercises, three times/week for 16 minutes with time to rest.
15886140|NCT03757169|Other|Control|The patients will receive verbal orientations about the OSA and the arterial hypertension.
15886141|NCT03757156|Other|Withdrawal of aspirin|People who are taking aspirin stop to taking aspirin.
15886142|NCT03757143|Drug|Povidone-Iodine-Alcohol|Povidone-Iodine-Alcohol will be used to disinfect the skin
15886143|NCT03757143|Drug|Chlorhexidine-Alcohol|Chlorhexidine-Alcohol will be used to disinfect the skin
15886144|NCT03757143|Device|Insyte Autoguard BC Winged|Pose of Insyte Autoguard BC Winged
15886145|NCT03757143|Device|Nexiva single port catheter, MaxZero needless connector, PureHub Deinfecting Caps and Posiflush prefilled saline syringes|Pose of Nexiva single port catheter
15886146|NCT03757130|Drug|AMG 598|AMG 598 dose
15886147|NCT03757130|Drug|Placebo|Calculated volume to match experimental drug.
15886148|NCT03757130|Drug|Liraglutide|Daily SC injection of liraglutide
15886149|NCT03757117|Drug|Feminizing hormone therapy|"Estradiol valerate was initiated at 2 mg PO daily and increased to 4 mg after 4 to 12 weeks
~Antiandrogen therapy with spironolactone started at a dose of 50 mg PO daily and increased every 4 weeks to 200 mg daily"
15886150|NCT03757117|Behavioral|Peer navigation|Transgender women community peer navigation
15886151|NCT03757104|Behavioral|micro-incentive|Residents in these communities are eligible to receive a R50 food voucher conditional on undergoing a home-based HIV test. If diagnosed with HIV, residents are eligible to receive a second R50 food voucher when they link to care within 6 weeks of the HIV test
15886152|NCT03757104|Behavioral|EPIC-HIV|Men in these communities are eligible to receive a tablet-based male-sensitive HIV decision support app (EPIC-HIV 1)to encourage them to test for HIV at home. If diagnosed with HIV and do not link to care within a month of HIV test, they become eligible to receive a tablet-based male HIV specific decision support app (EPIC-HIV 2) to encourage them to link to HIV care.
15886153|NCT03757104|Behavioral|micro-incentive and EPIC-HIV|"micro-incentives: Residents in these communities are eligible to receive a R50 food voucher conditional on undergoing a home-based HIV test. If diagnosed with HIV, residents are eligible to receive a second R50 food voucher when they link to care within 6 weeks of the HIV test.
~EPIC-HIV 1:
~Men in these communities are eligible to receive a tablet-based male-sensitive HIV specific decision support app (EPIC-HIV 1) to encourage them to test for HIV at home. If diagnosed with HIV and do not link to care within a month of HIV test, they become eligible to receive a tablet-based male HIV specific decision support app (EPIC-HIV 2) to encourage them to link to HIV care."
15886154|NCT03757091|Device|Laryngoscopy|Undergo video laryngoscopy
15886155|NCT03757091|Procedure|Tracheal Intubation|Undergo flexible scope intubation
15886156|NCT03757078|Drug|Relief Pro cream|Relief Pro cream:1.0 mg/gm Fluocortolone + 20 mg/gm Lidocaine; Administration according to clinical practice.
15886157|NCT03757078|Drug|Relief Pro rectal suppositories|Relief Pro rectal suppositories: 1.0 mg Fluocortolone + 40 mg Lidocaine; Administration according to clinical practice
15886158|NCT03757052|Diagnostic Test|Penicillin Skin Testing|Skin test protocol: prick skin tests (penicilloyl-polylysine 0.000012 mol/0.05 mL, penicillin G 10,000 U/mL, penoate 10,000 U/mL, ampicillin 100 mg/mL, amoxicillin 71 mg/mL, histamine/positive control, diluent/negative control), then intradermal skin tests (penicilloyl-polylysine 0.000012 mol/0.05 mL, penicillin G 10,000 U/mL, penoate 10,000 U/mL, ampicillin 1 mg/mL, diluent/negative control), administered as an intradermal injection of a standardized volume of 0.02 mL. Graded oral challenge with amoxicillin : a first dose of 50 mg of amoxicillin; 20-minute observation period; in the absence of any objective symptom of an allergic reaction, a second dose of amoxicillin of 450 mg; final observation period of 60 minutes, under nurse and medical supervision.
15886159|NCT03757039|Device|Multifocal soft contact lenses|Commercially available contact lenses
15886160|NCT03757039|Other|Progressive addition lens spectacles|Per subject's habitual prescription
15886161|NCT03757026|Other|Conventional Physical Therapy|"20-22 participants randomly assigned to receive 10 sessions of balance training. Conventional balance training group (PT) will receive individualized standard of care physical therapy with the goal of improving balance and mobility during sessions 3 through 12. The only instructions to the PT are that the focus of the course of care should be on balance and mobility and that there should be 10 sessions total. The first visit will include an initial evaluation and limited treatment. While the remaining 9 sessions will consist of 45 minutes of PT treatment."
15886162|NCT03757026|Other|Slip Training|20-22 participants randomly assigned to 1 session of slip training and 9 sessions of accompanied walking. Reactive slip training group (Slip) will complete a standing slip session using the current protocol of scaling slip distance and force to each individual and modulating the slip intensity across the session based on subject responses. Initial perturbation intensity (percent body weight and slip distance) will be based on the participant's miniBEST score and each subsequent perturbation intensity will be determined based on their response to the previous perturbations. The remaining nine interventional sessions will consist of accompanied walking for up to 45 minutes. Participants will walk at a comfortable pace while accompanied by a researcher around Cleveland State.
15886163|NCT03757026|Other|Harnessed gaming|20-22 participants randomly assigned to 10 sessions of harnessed gaming. Multidirectional harness group (MHG) will use a harness with the multidirectional OASUS frame and play selected Kinect™ active video games with varied balance demands, while standing on multiple balance training surfaces (e.g., solid floor, rocker board, foam, slider platform). Participants will wear the fall-arresting harness in the OASUS system for all game play. Motion data will be collected during gaming for Sessions 2, 6, and 10. Each game/surface will be played for about 5 to 6 minutes for 4 game/surface conditions per session. All participants will progress with the prescribed sequence of games and surfaces, progressing based on their rating of the previous three bouts of play.
15886164|NCT03757013|Drug|Apremilast|Apremilast
15886165|NCT03757000|Drug|YY-20394|YY-20394 is a new type of PI3K-δ selective inhibitor which differs structurally from idelalisib and its analogs, showing high potency against PI3Kδ, but with markedly improved selectivity (>1,000-fold selectivity for PI3K-δ versus PI3Kγ). This higher selectivity for PI3Kδ may decrease the risk of serious infection seen with idelalisib and especially with duvelisib due to strong immune suppression.Preclinical evaluation has demonstrated improved efficacy and safety for YY-20394 compared to idelalisib.
15886166|NCT03756987|Drug|Ropivacaine Injection|Ropivacaine will be injected in the erector spinae plane
15886167|NCT03756987|Drug|Normal saline|Normal saline will be injected in the erector spinae plane.
15886168|NCT03756974|Drug|BX-1|BX-1 (dronabinol), oral solution. All patients enrolled establish their individually tolerable dose by dose Titration.
15886169|NCT03756974|Drug|Placebo|Placebo of BX-1, oral solution
15886170|NCT03756961|Drug|Dexmedetomidine|The intervention group will obtain the pharmacological treatment during both perioperative. Pharmacological treatment in the intervention group differs solely from the patients in the control group by replacing opioids with the following non-opioid treatment:
15886171|NCT03756961|Behavioral|Person-centred care (PCC)|The intervention tests non-pharmacological interventions compared to conventional treatment, supplemented by an evidenced-based Person-centred care PCC approach throughout the continuum of the perioperative and until 4 weeks after discharge
15886172|NCT03756961|Drug|Esketamine|The intervention group will obtain the pharmacological treatment perioperatively. Pharmacological treatment in the intervention group differs solely from the patients in the control group by replacing opioids with the following non-opioid treatment:
15886173|NCT03756961|Drug|Lidocaine|The intervention group will obtain the pharmacological treatment perioperatively. Pharmacological treatment in the intervention group differs solely from the patients in the control group by replacing opioids with the following non-opioid treatment.
15886174|NCT03756961|Device|Transcutaneous Nerve Stimulation (TENS)|The intervention group will obtain non-pharmacological treatment by TENS during the entire hospital stay (both perioperative and post-operative) until discharge.
15886175|NCT03756961|Drug|Remifentanil|The control group receives general anesthesia with Remifentanil as the routine opioid drug during general anesthesia.
15886176|NCT03756961|Drug|Desflurane|The patient receives general anesthesia with Desflurane as the routine volatile anesthetic during general anesthesia
15886177|NCT03756961|Drug|Propofol|The patient receives general anesthesia with Propofol as the routine induction anaesthetic during general anesthesia
15886178|NCT03756961|Drug|Oxycodone|The control group receives Oxycodone as the routine pain management drug post-operative.
15886179|NCT03756948|Other|Usual Care|Treatment of Coagulation Disorders Using Standard Coagulation Tests and Blood Components
15886180|NCT03756948|Other|Thromboelastometry-Guided Therapy with Synthetic Factor Concentrates|Thromboelastometry-Guided Treatment of Coagulation Disorders Using Synthetic Factor Concentrates
15886181|NCT03756935|Procedure|All monitoring|Dicpleth and PI are obtained a posteriori from the PPG waveform reconstruction and blindly from ABP values. Dicpleth is defined as the ratio of the height of the dicrotic notch (from nadir point of the complex to the notch) to the height of the systolic peak (from nadir point of the complex to the pic), measured at end-expiratory time (average of 3 consecutive complex). PI is calculated as the ratio of the pulsatile component of the PPG signal and the continuous component.
15886182|NCT03756922|Drug|FDL169|CFTR corrector
15886183|NCT03756922|Drug|FDL176|CFTR potentiator
15886184|NCT03756896|Drug|Carfilzomib|Given IV
15886185|NCT03756896|Drug|Dexamethasone|Given PO
15886193|NCT03756844|Behavioral|Just Right Challenge Food Club|Systematic desensitization, positive reinforcement and escape extinction at a level of just right challenge.
15886194|NCT03756831|Diagnostic Test|Core Stability Assessment|Core Stability Assessment will be consisted of bilateral static balance with open and close eye, right foot balance test, and dynamic balance test.
15886195|NCT03756818|Drug|Paclitaxel|Given IV
15886196|NCT03756818|Other|Pharmacokinetic Study|Correlative studies
15886197|NCT03756818|Drug|Spleen Tyrosine Kinase Inhibitor TAK-659|Given PO
15886198|NCT03756805|Device|upper airway stimulation|One group of patients with UAS
15886199|NCT03756805|Device|continuous positive airway pressure|One group of patients with CPAP
15886202|NCT03756779|Other|Dietary intervention|Dietary intervention with dietary modification of fat intake.
15886203|NCT03756766|Diagnostic Test|RSV point of care testing|Patients will have 2 nasopharyngeal swabs, a nasal swab, a stool and urine taken at baseline/ enrolment and the RSV positive ARTI group will have samples repeated at 6-8weeks.
15886204|NCT03756753|Diagnostic Test|Results available to provider|Results of point of care testing are given to provider
15886205|NCT03756740|Other|telerehabilitation and physical therapy|subject will receive the LBP exercises as a video to his/her mobile or e-mail
15886206|NCT03756740|Other|control|subjects will receive the LBP exercises as printed pictures on paper
15886207|NCT03756727|Drug|Ascorbic Acid|Patients in Ascorbic acid group received 2g of intravenous Ascorbic acid at the night before surgery, during the surgery and five days after surgery (once a day).
15886208|NCT03756727|Drug|Saline|Patients in Control Comparator group received saline 10ml at the night before surgery, during the surgery and five days after surgery (once a day).
15886209|NCT03756701|Behavioral|Mind body skills|"2 hour skill sessions that focus on mindfulness: The topics for each session is based upon the Centers for Mind Body Medicine model. Both groups will follow this same weekly topic schedule.
~Introduction and Drawings
~Autogenic Training and Biofeedback
~Guided Imagery
~Meditation
~Mobilizing, Transforming, and Celebrating Emotion
~Genograms part 1
~Genograms part 2
~Mindful Eating and Healthy Nutrition
~Spirituality
~Closing Drawings and Ritual"
15886210|NCT03756688|Device|RestoreX PTT - 6 months|Penile traction therapy in straight position for all 6 months.
15886211|NCT03756688|Device|RestoreX PTT - 3 months|Penile traction therapy in straight position for first phase (3 months)
15886212|NCT03756675|Other|haplotype PBSCT|"haplotype peripheral blood stem cell transplantation (PBSCT) of GIAC system"
15886213|NCT03756662|Device|ARGOS-SC suprachoroidal pressure sensor|The sensor device is intended to be permanently implanted suprachoroidal in the human eye during non-penetrating glaucoma surgery.
15886214|NCT03756649|Procedure|Blood Draw|50 ml will be collected
15886215|NCT03756649|Procedure|Urine Collection|50 ml will be collected
15886216|NCT03756649|Procedure|Stool Collection|Three 25 ml tubes will be collected
15886217|NCT03756636|Procedure|"Underwater mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)"|"Underwater mucosectomy with submucosal injection of viscous solution -SIC 8000 (EleviewTM)"
15886218|NCT03756623|Drug|Metformin powder|0.5g of Metformin powder administered three times a day orally before meal
15886219|NCT03756623|Drug|Probiotics powder|0.5g of Probiotics powder administered three times a day orally before meal
15886220|NCT03756623|Other|Placebo powder|0.5g of Placebo powder administered three times a day orally before meal
15886221|NCT03756610|Device|Active tACS|Placement of stimuli electrodes will be: a) active electrode over the left DLPFC (F3), and b) reference electrode over the right parietal region (P2). The exact location of electrodes will be determined by the 10/20 EEG method with EEG cap. Subjects will have tACS sessions on consecutive days (weekends and holidays excluded). Each subject will have 10 active tACS sessions.The active tACS group will be stimulated with a 2 mA current for 20 minutes.
15886222|NCT03756610|Device|Sham tACS|Placement of stimuli electrodes will be: a) active electrode over the left DLPFC (F3), and b) reference electrode over the right parietal region (P2). The exact location of electrodes will be determined by the 10/20 EEG method with EEG cap. Subjects will have tACS sessions on consecutive days (weekends and holidays excluded). Each subject will have 10 sham tACS sessions.The sham tACS group will have stimulation lasting only 40 seconds though the electrodes will remain in place for 20 min.
15886223|NCT03756610|Device|Active boosting|Placement of stimuli electrodes will be: a) active electrode over the left DLPFC (F3), and b) reference electrode over the right parietal region (P2). The exact location of electrodes will be determined by the 10/20 EEG method with EEG cap. Subjects will have tACS sessions on consecutive days (weekends and holidays excluded).One month later after initial treatment, each subject will have 5 booster sessions of active tACS.The active boosting group will be stimulated with a 2 mA current for 20 minutes.
15886224|NCT03756610|Device|Sham boosting|Placement of stimuli electrodes will be: a) active electrode over the left DLPFC (F3), and b) reference electrode over the right parietal region (P2). The exact location of electrodes will be determined by the 10/20 EEG method with EEG cap. Subjects will have tACS sessions on consecutive days (weekends and holidays excluded).One month later after initial treatment, each subject will have 5 booster sessions of sham tACS.The sham boosting group will have stimulation lasting only 40 seconds though the electrodes will remain in place for 20 min.
15886225|NCT03756597|Device|ReCIVA|The ReCIVA breath sampler contains a CO2 and pressure sensor, which allows the operator to monitor the breath sampling procedure and patient comfort. Both the operator and the patient can pause or abort the breath sampling procedure within seconds by removing the mask. The time investment required from patients is approximately 15 minutes for consenting and medical history and 10 minutes per breath collection.
15886226|NCT03756597|Device|CASPER|Minimizes contamination of breath samples by external VOCs Removes need for clean air supply line
15886227|NCT03756584|Device|Theta-burst stimulation|iTBS comprises 3-pulse 50-Hz bursts, applied every 200 ms (at 5 Hz) as described previously (Huang, Edwards et al. 2005) and consists of 2-second trains with an inter-train-interval of 8 seconds. We will repeat trains (30 pulses; 10 bursts) for 20 times to reach a total number of 600 pulses per session (3x10x20)
15886228|NCT03756571|Other|Ankle Foot Orthoses-Footwear Combination|This is a solid AFO with angle of ankle in AFO and shoe modifications per algorithm based on physical exam and visual observation of lower extremity kinematics through stance phase of walking.
15886229|NCT03756571|Other|Traditional Solid Ankle AFO (TSAFO)|This is a solid ankle AFO with angle of ankle in AFO at 90 degrees or neutral dorsiflexion/plantarflexion.
15886230|NCT03756558|Device|Cross-Seal System|Use of the Cross-Seal system to close the femoral arteriotomy
15886231|NCT03756519|Behavioral|Exercise|A standardized exercise program tailored to the individual based on their directional preferences and current functional abilities.
15886232|NCT03756519|Behavioral|Advice to stay active and engaged in usual activities.|Participants will be advised that staying physically active and continuing to participate in usual activities improves recovery. This verbal advice will be reinforced with a written handout.
15886233|NCT03756519|Behavioral|Advice on use of ice or heat|Participants will be advised on the appropriate use of ice or heat to manage pain. This verbal advice will be reinforced with a written handout.
15886234|NCT03756519|Other|Advise regarding use of medications|Participants will receive education regarding the use of non-steroidal anti-inflammatory medications (NSAIDs) for pain relief, if needed and if the patient is appropriate for NSAIDs. Information regarding specific recommended doses, potential benefit and risk will be discussed.
15886235|NCT03756506|Device|Novel Microbicidal Liquid Polymer|The polymer is a 510K FDA cleared medical device indicated for providing a covering over minor wounds and scrapes that are clean and dry. The microbicidal liquid solution consists of organic polymers . The unique formulation eradicates any organisms (bacteria, fungi, viruses) it comes in contact with. This is a result of the solvent's activity against an infinite number of organisms After eradication is complete, the solvent then transitions into a clear, elastomeric, non-odorous film for covering disrupted tissue. The film protects the wound against entry of water, dirt, and germs. The film is elastomeric and protects in difficult regions where flexing, bending and creasing skin occurs. The clear film forms in less than a minute.6 DuraDerm® should not be used to the treat deep infected wounds. DuraDerm® can be used to protect disrupted skin surface of wounds that are clean and dry.
15886236|NCT03756493|Procedure|Periodontal Surgery with OFD+ABG+L-PRF|Patients will be treated by periodontal surgical flaps with the addition of L-PRF+ Autogenous Bone Graft filling material.
15886237|NCT03756493|Procedure|Periodontal Surgery with OFD+ABG|Patients will be treated by periodontal surgical flaps with the addition of Autogenous Bone Graft filling material.
15886238|NCT03756493|Procedure|Periodontal Surgery OFD|Patients will be treated by Open Flap Debridement without use of filling material.
15886239|NCT03756467|Behavioral|Girl Empower Program|Girl Empower (GE) encourages adolescent girls living in rural areas of Nimba County, Liberia to partake in weekly mentored community-based workshops on life skills, selfcare, and financial literacy.
15886242|NCT03756441|Behavioral|Mindfulness meditation|This intervention is a meditative practice which the individuals will practive in their daily life following the MBHP protocol
15886243|NCT03756441|Behavioral|Psychotherapy group|Caregivers will learn the technique of group problem solving
15886244|NCT03756428|Procedure|Deep dry needling in tibialis posterior|The inspector, with gloves, disinfects the area to be treated with 70º alcohol. Once the alcohol is applied, the intervenor locates and takes the myofascial trigger point and places the needle with the guide tube resting on the skin of the patient. The inspector holds the guide tube between the index and middle fingers lightly touch the needle with the index finger of the other hand to insert the needle perpendicularly into the skin, directing it towards the inspector's thumb. Once the needle is inserted subcutaneously, the guide tube is removed. The controller deepens the needle to myofascial trigger point, and makes fast inputs and outputs into it. The rapid exit is made to the subcutaneous cellular tissue, outside the muscle, but not outside the skin. Next, hemostasis is performed in the area. Once this hemostasis is completed, the patient is incorporated and dressed.
15886245|NCT03756428|Procedure|Sham technique in tibialis posterior|The patient lies on the stretcher without the trousers. The interventor, with the guide tube, simulates the technique of puncture in the right twin of the subject. The comptroller cleans the area with 70º alcohol. Once the alcohol is applied, he performs the simulated dry needling technique in a plane with his index and middle fingers with the guide tube. It is important that the subject has his head stuck in the hollow of the head of the stretcher throughout the technique to make a correct masking.
15886246|NCT03756415|Device|"DiMax Zero Total face mask R,"|a non-CO2 rebreathing device included directly in the full face mask
15886247|NCT03756415|Device|traditional face mask|a traditional mask without a non-CO2 rebreathing device included directly in the full face mask
15886248|NCT03756389|Drug|BMX-010|Safety and efficacy of BMX-010 in topical treatment of rosacea.
15886249|NCT03756363|Procedure|Non-solvent|Root canal filling removal using ProTaper retreatment instruments. Single session retreatment procedures.
15886250|NCT03756363|Procedure|Solvent|Root canal filling removal using ProTaper retreatment instruments in combination with a gutta percha solvent. Single session retreatment procedures.
15886251|NCT03756350|Device|1060nm diode laser|Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area.
15886254|NCT03756324|Drug|CHPM (Chinese Herbal Patent Medicine )|Pugongying (Herba Taraxaci) granules is named as Pugongying Granules in China and produced by Kunming pharmaceutical factory co. LTD. The form is granules, and the participants will take the medicine after dissolved as 15g/tid for 3 days, and the investigators will follow them up for 7 days when the participants are stopped administrating.
15886255|NCT03756324|Drug|Antibiotics Cefdinir Capsules|Cefdinir Capsules is also named as Cefdinir and produced by Astellas Pharma Inc. The form is capsule, and participants will take orally the capsules with water as 0.1g/tid for 3 days, and the investigators will follow them up for 7 days when the participants are stopped administrating.
15886507|NCT03754504|Dietary Supplement|Cranberry powder|3 capsules /day of whole cranberry powder (500mg/each)
15886256|NCT03756324|Behavioral|Education|Doctors will give suggestions and the medical orders to all participants, including dietary, emotional regulation and the knowledge of breast-feeding.
15886257|NCT03756324|Drug|Antibiotics Cefdinir Capsules|Cefdinir Capsules is also named as Cefdinir and produced by Astellas Pharma Inc. The form is capsule, and participants will take orally the capsules with water as 0.1g/tid for 2 days, and the investigators will follow them up for 7 days when the participants are stopped administrating.
15886258|NCT03756311|Drug|NanoPac (sterile nanoparticulate paclitaxel) Powder for Suspension|
15886259|NCT03756298|Drug|Atezolizumab|Atezolizumab is 1,200 mg iv. administered every 3 weeks for 8 cycles with capecitabine (2,000mg/m2/day, day 1-14, every 3 weeks for 8 cycles)
15886260|NCT03756298|Drug|Capecitabine|capecitabine monotherapy (2,500mg/m2/day, day 1-14, every 3 weeks for 8 cycles)
15886261|NCT03756285|Drug|AZD4831|AZD4831 tablet taken orally for 90 days.
15886262|NCT03756285|Drug|Placebo|Placebo tablet taken orally for 90 days.
15886263|NCT03756272|Procedure|Bupivacaine block|stellate ganglion bupivacaine injection
15886264|NCT03756272|Procedure|Placebo ganglion block|stellate ganglion sodium chloride injection
15886265|NCT03756259|Behavioral|Mobile Health (mHealth) for Pneumonia|Audiovisual mobile based application will be used to counsel caregivers of children under five on pneumonia and its prevention. This will be coupled with text and voice message dissemination to the cell phones of caregivers and active pneumonia case finding by the LHWs which will be managed according to severity.
15886266|NCT03756246|Biological|Influenza Vaccine|The appropriate quadrivalent influenza vaccine for the give year will be given to subjects.
15886267|NCT03756233|Drug|Remifentanil|Remifentanil is a potent, short-acting synthetic opioid analgesic drug. It is given to patients during surgery to relieve pain and as an adjunct to an anesthetic.
15886268|NCT03756220|Drug|Combination therapy of vitamin C and thiamine|Vitamin C (50 mg/kg up to 3 g, every 12 hours) and thiamine (200 mg every 12 hours) intravenously administered mixed in 50 mL solution bags of normal saline for 2 days
15886269|NCT03756220|Drug|Normal saline solution|Normal saline solution in a volume to match the treatment components administered mixed in 50 mL solution bags of normal saline for 2 days
15886270|NCT03756207|Procedure|multidisciplinary bladder-preservation therapy|Maximal transurethral resection followed by radiotherapy with concomitant radio-sensitizing chemotherapy
15886271|NCT03756194|Device|Socially-assistive Pepper robot with a CARESSES cultural competence solution|"Week 1. On the first day, training will be provided to the participants enabling them to familiarise themselves with the robot's functionalities. The robot will be culturally aware i.e., it will be aware of the participants' cultural background prior to the testing commencing. As such, it will pre-load the appropriate CKB and apply this during its time with the participants. During the next two sessions, the robot will interact and provide culturally-competent assistance, however, it will not learn and adjust to the participants' individual cultural values and preferences.
~Week 2. The participants will again utilize the robot for three days, but it now will learn from the responses it receives from them, consequently interacting in a culture-specific personalised way."
15886272|NCT03756194|Device|Socially-assistive control Pepper robot with an alternative CARESSES solution|"Week 1. On the first day, training will be provided to the participants enabling them to familiarise themselves with the robot's functionalities. During the next two sessions, the CARESSES control robot will not be culturally aware: it will pre-load a generic and more limited CKB that is not tailored for anyone's cultural profile. It will also not learn and adjust to the participants' values and preferences.
~Week 2. Participants will again utilize the robot for three days, but the CARESSES control robot will now be configured to be able to learn and adapt to the individual's particular profile. This robot's learning will not include propagation: improving its cultural knowledge base in one area will not also automatically lead to knowledge improvements in other related areas. This robot will possess the same full suite of functions as the CARESSES robot although will be less likely to offer these in a culturally appropriate way."
15886273|NCT03756181|Behavioral|Five-week MSC program (MSC5wk)|This program adaptation will consist of conducted meditative practices, discussions, and background information within a group setting of no more than 25 students per group. The facilitator may discuss the student's experience and encourage group sharing within the course of the session. These discussions will reinforce the guiding principles of mindfulness meditation. There will also be sessions dedicated to incorporating or mindfulness in daily life, with more detailed instructions, as well as encouraging a 30- minute daily home practice.
15886274|NCT03756168|Device|1060nm Diode laser|Non-invasive medical aesthetic device designed for body contouring. The device is comprised of a console, four 1060nm diode laser applicators which are 60x60 mm in size. There is a belt included with the system to allow for the secure application of the applicators to the treatment area.
15886275|NCT03756155|Procedure|isometric intervention|The research participants will perform isometric repetitions against the hand held dynamometer
15886276|NCT03756142|Diagnostic Test|Motion Analysis|Analysis of orthostatic posture, initiation of walking and walking by a motion analysis system
15886277|NCT03756129|Drug|MIJ821|Different dosages and different regimen for MIJ821
15886278|NCT03756129|Drug|Placebo|Infusion
15886279|NCT03756129|Drug|Ketamine|Infusion
15886280|NCT03756116|Procedure|Epinephrine sprayed on the papilla|Patients received sublingual Nitroglycerin will receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla before the withdrawal of endoscope.
15886281|NCT03756116|Procedure|Saline sprayed on the papilla|Patients received sublingual Nitroglycerin will receive 20 ml of normal saline sprayed on the duodenal papilla before the withdrawal of endoscope.
15886282|NCT03756103|Drug|SPH3127 tablet Dose 1|Oral SPH3127 tablet, a kind of renion inhibitor, 50 mg, once daily for 8 weeks.
15886283|NCT03756103|Drug|SPH3127 tablet Dose 2|Oral SPH3127 tablet, a kind of renion inhibitor, 100 mg, once daily for 8 weeks.
15886284|NCT03756103|Drug|SPH3127 tablet Dose 3|Oral SPH3127 tablet, a kind of renion inhibitor, 200 mg, once daily for 8 weeks.
15886285|NCT03756103|Drug|SPH3127 tablet Placebo|Oral SPH3127 tablet placebo, once daily for 8 weeks.
15886286|NCT03756090|Drug|Palbociclib|Palbociclib will be administered orally as 125mg capsules, daily on a schedule of 3 weeks (21 days) on, 1 week (7 days) off of a 4 week [28 days] cycle.
15886508|NCT03754504|Dietary Supplement|Placebo|3 capsules/day of a placebo comparator
15897055|NCT03673111|Drug|Placebo|0.9% saline
15886287|NCT03756090|Drug|Placebo oral capsule|Placebo oral capsule will be administered orally as 125mg capsules, daily on a schedule of 3 weeks (21 days) on, 1 week (7 days) off of a 4 week [28 days] cycle.
15886288|NCT03756090|Drug|Epirubicin|Epirubicin (90mg/m2, D1) cycled every 14 days for the first 4 cycles.
15886289|NCT03756090|Drug|Cyclophosphamide|Cyclophosphamide (600mg/m2, D1) cycled every 14 days for the first 4 cycles.
15886290|NCT03756090|Drug|Paclitaxel|Paclitaxel (80mg/m2, D1) cycled every 14 days for the later 4 cycles.
15886291|NCT03756077|Diagnostic Test|68Ga-PSMA-11 and/or 18F-FDG PET/MR, PET/CT|0.05-0.06 mCi per kilogram bodyweight of 68Ga-PSMA, 0.1-0.15 mCi per kilogram bodyweight of 18F-FDG will be injected intravenously prior to imaging
15886292|NCT03756064|Drug|Pyrotinib|Pyrotinib: 400mg orally daily
15886293|NCT03756064|Drug|Trastuzumab|Trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 6 cycles;
15886294|NCT03756064|Drug|Docetaxel|Docetaxel: 75mg/m2 for a total of 6 cycles
15886295|NCT03756064|Drug|Carboplatin|Carboplatin: AUC=5 for a total of 6 cycles
15886296|NCT03756064|Drug|Placebo Oral Tablet|Placebo Oral Tablet: 400mg orally daily
15886297|NCT03756051|Other|Prospective Longitudinal Data|We will prospectively follow the cohort using electronic medical record to document the hepatocellular carcinoma screening process and characterize physical and financial harms related to positive or indeterminate screening results and burden of inappropriate screening. Patients are anticipated to undergo hepatocellular carcinoma screening every 6-12 months, so each patient will have ~4-8 screening encounters over the study duration. We will use manual chart review to determine intent of ultrasound exams (screening vs. diagnostic) and test results. Receipt of follow-up tests after positive or indeterminate screening results will be identified through electronic medical record extraction using Current Procedural Terminology (CPT) codes for CT, MRI, and biopsy.
15886298|NCT03756051|Other|Surveys and Semi-structured Interviews|"We will use surveys and semi-structured interviews to characterize psychological harms after positive or indeterminate screening tests. Patient surveys will include patient-reported scales to measure psychosocial factors at three times points: baseline, 1 month after screening result, and 4 months after screening result. Semi-structured interviews will be conducted via telephone to explore patient attitudes toward risk perception, test follow-up, competing demands, and downstream harms, particularly financial issues (e.g., out-of-pocket costs, access to insurance, and juggling hepatocellular carcinoma screening process completion with competing demands-work and family)."
15886299|NCT03756038|Drug|Placebos|In this study, patients will receive oral placebo, an inactive solution that looks like the study drug, but contains no active ingredients
15886300|NCT03756038|Drug|Lorazepam|The purpose of this study is to determine whether a single low dose of Lorazepam/Ativan (1mg) can relieve pain and reduce negative mood in the emergency department and for 2 weeks after emergency department treatment.
15886301|NCT03756025|Procedure|Atraumatic Restorative Treatment (ART)|The atraumatic restorations were performed in the dental office by a single operator trained in the ART Technique [20], who received the restorative material already prepared by a trained auxiliary, ensuring blinding of the study. The restorative procedure performed in relative isolation and without the use of anesthesia consisted of removal of the carious tissue using hand instrument excavators and dentin spoons, with subsequent conditioning of the cavity with a polyacrylic acid solution at 11.5% (DFL) applied with a microbrush for 10 seconds. Immediately after, the cavity was washed and dried with cotton balls. In this step, according to the randomization, the respective GIC was inserted and subsequent digital compression was performed for 30 seconds. After occlusal adjustment, the ARTs were protected with finish gloss Alfa Bond® (DFL).
15886302|NCT03756012|Device|Algovita Spinal Cord Stimulation System|The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.
15886303|NCT03755999|Other|The premature infant oral motor intervention (PIOMI)|The premature infant oral motor intervention (PIOMI) is an oral motor program that provides assisted movement to activate muscle contraction and provides movement against resistance to build strength in the areas of the mouth necessary for feeding. It is designed to increase the maturation of neural structures, improving their ability to suck and swallow.
15886304|NCT03755986|Device|ATOMO Diagnostic Test|The ATOMO diagnostic test device is the only intervention used in this study.
15886305|NCT03755973|Drug|CFA|Long-acting exogenous ovarian stimulation
15886306|NCT03755973|Drug|rFSH|Daily rFSH
15886307|NCT03755973|Procedure|Fixed daily rFSH dosing protocol of 200 IU|The dose of daily rFSH is fixed at 200 IU
15886308|NCT03755973|Procedure|Step-down daily rFSH dose|The dose of daily rFSH is progressively reduced
15886309|NCT03755960|Procedure|acupuncture|semistandardized selection of acupuncture points according to the clinical presentation of diabetic peripheral neuropathy (DPN) symptoms; 12 treatments over 8 weeks
15886310|NCT03755960|Drug|routine care|pharmacological routine care (antidepressants, anticonvulsants, opioids, nonsteroidal antiinflammatory drugs)
15886311|NCT03755947|Drug|Ibrutinib|Ibrutinib Oral Capsule [Imbruvica] Tablets 120 mg. Oral. 420mg/day, day 1 to 28, every 28 days. 3 cycles.
15886312|NCT03755947|Drug|Obinutuzumab|Obinutuzumab Injection. Intravenous Solution [Gazyva] Parenteral. 1000 mg, day 1 of every cycle, every 28 days. 6 cycles.
15886313|NCT03755947|Drug|Venetoclax|Venetoclax Oral Tablets [Venclexta] Tablets 100 mg. Oral. 400 mg/day. Day 1 to 28, every 28 days. 12 cycles.
15886316|NCT03755921|Other|bried and intensive therapy|Speech Therapy Exercises
15886317|NCT03755908|Device|Forced oscillation technique (FOT)|FOT will be measured using the TremoFlo C-100 Airwave Oscillometry System (Thorasys , Montreal, Quebec, Canada). R5, R20, R5-20 (resistances in the reported frequency), X5 (reactance in 5hz) and Ax5 (reactance area in 5hz) will be reported.
15886318|NCT03755895|Other|formal hypnosis|patients will have brachytherapy detachment under Kalinox and formal hypnosis
15886319|NCT03755895|Drug|Kalinox|patients will have brachytherapy detachment under Kalinox
15886320|NCT03755882|Device|ACUVUE® DEFINE™ Vivid Style|TEST Lens
15886321|NCT03755882|Device|LACELLE™ Sparkling Brown|CONTROL Lens
15886509|NCT03754491|Behavioral|One stage treatment for mild and moderate cholangitis with choledocholithiasis|one stage of stone removal in mild or moderate cholangitis.
15886322|NCT03755869|Drug|Anlotinib|Anlotinib ( 12mg, QD, PO, d1-14, 21 days per cycle), take once when limosis in the morning. If patients cannot suffer from AEs, they can get declined dosage.
15886323|NCT03755856|Other|Questionnaire|Health-related quality of life
15886324|NCT03755843|Diagnostic Test|PASSIVE LEG RISING|"Pasive Leg Rising: In the supine method, the legs are lifted passively from the horizontal position to a 30° to 45° elevation while the head of the bed is flat.
~Fluid Challenge: Fluid responsiveness is generally defined as an increase in SV or CO of 10% to 15% in response to a 250 mL crystalloid fluid bolus"
15886325|NCT03755830|Other|Skin biopsy|Two skin biopsies (lesional and non-lesional) will be taken from every patient. Also a skin biopsy will be taken from each control subject.
15886326|NCT03755817|Device|SCENAR application|Active SCENAR application on the painful area
15886327|NCT03755817|Device|SCENAR application with the device off|Placebo SCENAR application on the painful area
15886328|NCT03755804|Drug|bendamustine|Given intravenously (IV)
15886329|NCT03755804|Drug|Etoposide|Given intravenously (IV)
15886330|NCT03755804|Drug|Doxorubicin|Given intravenously (IV)
15886331|NCT03755804|Drug|Bleomycin|Given intravenously (IV)
15886332|NCT03755804|Drug|Vincristine|Given intravenously (IV)
15886333|NCT03755804|Drug|Vinblastine|Given intravenously (IV)
15886334|NCT03755804|Drug|Prednisone|Given orally (PO)
15886335|NCT03755804|Drug|Filgrastim|Given subcutaneously (SQ) or IV
15886336|NCT03755804|Drug|Brentuximab Vedotin|Given intravenously (IV)
15886337|NCT03755804|Drug|Cyclophosphamide|Given intravenously (IV)
15886338|NCT03755804|Drug|DTIC|Given intravenously (IV)
15886339|NCT03755804|Other|Quality of Life Measurements|Quality of Life measurements will be done in low-risk cycles 1 and 2 BEABOVP, intermediate-risk cycles 1, 2 and 3 BEABOVP and high-risk cycles 1 and 2 AEPA and cycles 1, 2, 3, and 4 CAPDac. QOL will be done at year 1, 2 and 5 for all risk groups.
15886340|NCT03755804|Radiation|Radiotherapy|Residual node radiotherapy will be given at the end of all chemotherapy only to involved nodes that do not have an AR after 2 cycles of therapy for all risk groups. Radiotherapy will be administered after completion of all chemotherapy upon hematologic count recovery.
15886341|NCT03755791|Drug|Cabozantinib|Supplied as 20-mg tablets; administered orally daily at 40 mg
15886342|NCT03755791|Drug|Cabozantinib|Supplied as 60-mg tablets; administered orally once daily at 60 mg
15886343|NCT03755791|Drug|Sorafenib|Supplied as 200-mg tablets; administered orally twice daily at 400 mg
15886344|NCT03755791|Drug|Atezolizumab|Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
15886345|NCT03755778|Drug|EDP-938|Subjects will receive EDP-938 once daily on Day 1 and 14 (Part 1)
15886346|NCT03755778|Drug|EDP-938|Subjects will receive EDP-938 once daily on Day 1 and 14 (Part 2)
15886347|NCT03755778|Drug|EDP-938|Subjects will receive EDP-938 once daily on Day 1 and 8 (Part 3)
15886348|NCT03755778|Drug|Itraconazole|Subjects will receive itraconazole once daily from Day 5 to Day 18
15886349|NCT03755778|Drug|Rifampin|Subjects will receive rifampin once daily from Day 5 to Day 16
15886350|NCT03755778|Drug|Quinidine|Subjects will receive quinidine once daily from Day 5 to Day 12
15886351|NCT03755765|Drug|Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet|Amoxicillin-Clavulanate 875 Mg-125 Mg Oral Tablet
15886352|NCT03755765|Biological|BB-12|Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt
15886353|NCT03755765|Other|Control|Yogurt without Bifidobacterium animalis subsp. lactis BB-12 (BB-12)
15886354|NCT03755752|Procedure|Phacoemulsification with and without Trypan Blue capsule staining|Phacoemulsification for patients with diabetic retinopathy having cataract in both eyes. One eye underwent phacoemulsification with trypan blue capsule staining and the other eye underwent phacoemulsification without trypan blue.
15886355|NCT03755739|Drug|Checkpoint inhibitor (CPI) such as Pembrolizumab|vein, artery, or intra-tumor infusion of checkpoint inhibitor (CPI) such as Pembrolizumab and/or Ipilimumab
15886358|NCT03755700|Drug|Vitamin E|As a gel capsule of vitamin E 800 IU orally 2 hours before intervention and 400 IU orally 4 hours after intervention
15886359|NCT03755700|Drug|N-acetyl cysteine|As an effervescent tablets of NAC 1200 mg orally 2 hours before intervention and 1200 mg orally 4 hours after intervention
15886360|NCT03755700|Drug|Placebo oral capsule|The placebo of vitamin E as a soft gel capsule with the consumption order similar to vitamin e group
15886361|NCT03755700|Drug|Placebos|The placebo of n-acetylcysteine as a tablet with the consumption order similar to n-acetylcysteine group
15886362|NCT03755700|Drug|Normal Saline Flush, 0.9% Injectable Solution|Normal saline 0.9% infusions (1 mL/kg) for 12 hours prior to and after coronary catheterization
15886363|NCT03755687|Other|Art Therapy Intervention|Standardized mixed media art directives.
15886364|NCT03755674|Procedure|CHRONOTYPE-ADJUSTED DIET|Those patients followed a daily caloric distribution attending to their chronotype. In this regards, 'morning' subjects ate a higher quantity of calories at the first part of the day, while 'evening' subjects ate a higher amount of calories at the second half of the day.
15886365|NCT03755661|Behavioral|MI&TXT4MSM|brief in-person intervention followed by text messaging
15886366|NCT03755648|Other|Treadmill training|The motorized treadmill treatment parameters considered will be 50 Hertz, 10 Ampere and 220 Volts. The speed of treadmill will be controlled with a single finger tip allowing an individual to exercise in safe environment with sufficient space.The treadmill training will be provided by giving instructions first and then warm up will be given for 5 minutes prior to the training. The children will be upright with the feet flat on treadmill platform. The height of handrails will be adjustable according to every child thus keeping their gaze forward. The training will be ended at cool down period of 5 minutes.The treatment session will be thirty minutes for each group, six times a week for three months.
15886367|NCT03755648|Other|traditional physical therapy|Traditional therapy includes hot pack for 15 minutes and stretching for 20 minutes
15886368|NCT03755648|Other|Delorme resistance exercise|Delorme Resistance Training was also initiated with 5 minute warm up period. It was started with 10 Repetition Maximum and was gradually increased. The treatment session was thirty minutes for each group, six times a week for three months.
15886369|NCT03755635|Combination Product|The WHO multimodal hand hygiene strategy|Comprises five essential elements; system change-availability of alcohol-based hand rub at the point of care and/ or access to safe continuous water supply and soap and towels; training and education of healthcare professionals; monitoring of hand hygiene practices and performance feedback; reminders in the workplace; and the creation of a hand hygiene safety culture with the participation of both individual healthcare workers and senior hospital managers.
15886370|NCT03755622|Device|Conventional Transpalatal Arch (TPA)|In Group C, upper molar bands selection will be carried out by direct intra oral procedure. The conventional TPA is made on the stone working models.
15886371|NCT03755622|Device|Transpalatal Arch (TPA) fabricated from 3D reconstructed model|In Group 3D, upper molar bands selection will be carried out on the 3D printed model instead of direct intra oral procedure. The 3D TPA will be fabricated on the 3D reconstructed model while the conventional TPA is made on the stone models.
15886372|NCT03755609|Drug|Oxycodone|0.1 mg/kg intravenously
15886373|NCT03755609|Drug|fentanyl|1ug/kg intravenously
15886374|NCT03755596|Drug|Z. officinale extract|Oral dose of 160mg dry ginger root (Z. officinale) extract in tablet form.
15886375|NCT03755583|Dietary Supplement|Exclusive Enteral Nutrition|a complete liquid diet of formula for 8 weeks were adminstered in Crohn's Diseas patients ,Nutritional intake was based on the child's estimated energy requirements, no regular table food during 8 weeks treament.
15886376|NCT03755570|Diagnostic Test|Repeatable Assessment of Neuropsychological Status|Cognitive Function Test (Questionnaire-based)
15886377|NCT03755570|Diagnostic Test|Hospital Anxiety and Depression Scale|Cognitive Function Test (Questionnaire-based)
15886378|NCT03755570|Diagnostic Test|Frontal Assessment Battery|Cognitive Function Test (Questionnaire-based)
15886379|NCT03755570|Diagnostic Test|Trail Making Test Part A and B|Cognitive Function Test (Questionnaire-based)
15886380|NCT03755570|Diagnostic Test|Test of Premorbid Functioning|Cognitive Function Test (Questionnaire-based)
15886381|NCT03755557|Drug|Rhinocort|Application of a nasal spray
15886382|NCT03755557|Drug|Budesolv|Application of a nasal spray
15886383|NCT03755557|Other|Placebo|Application of a nasal spray
15886384|NCT03755531|Drug|Carbetocin|"Heat stable Carbetocin, a clear colourless solution. Oxytocic activity: approximately 50 IU of oxytocin/vial. One ml of Carbitocin (100 mcg), was given as a bolus intravenous injection, slowly over 1 minute after labor of the baby at once. It was used once and no further doses were given.
~Drug was kept in cold storage (2 to 8°C)."
15886385|NCT03755531|Drug|Oxytocin|"Oxytocin, a clear colourless solution. One ml of oxytocin (10 IU), was given as a bolus intravenous injection over 1 minute, after labor of the baby at once. Further doses can be given accordingly.
~Drug was kept in cold storage (2 to 8°C)."
15886386|NCT03755518|Drug|FEDRATINIB|A potent and selective inhibitor of JAK2 kinase activity
15886387|NCT03755518|Drug|Luspatercept|Luspatercept will be 1.33 mg/kg administered as a subcutaneous injection concomitantly with Fedratinib.
15886388|NCT03755505|Diagnostic Test|obtain samples from sputum, feces and urine|Samples are obtained from participants. No further intervention is required. Obtained samples will be further analyzed.
15886389|NCT03755492|Other|Absorbent pad for urinary incontinence|6 month supply provided to patients as needed for urinary incontinence after radical prostatectomy
15886390|NCT03755479|Device|Hybrid Closed Loop Insulin Pump Minimed 670G|Five Day Group Education on Minimed 670G
15886391|NCT03755466|Drug|"Baricitinib, olumiant®"|To examine the effects of baricitinib in RA patients
15886392|NCT03755466|Drug|"Biologics"|To examine the effects of biologics in RA patients
15886393|NCT03755466|Drug|Tofacitinib 5 MG [Xeljanz]|To examine the effects of tofacitinib in RA patients
15886394|NCT03755453|Device|Hearing aid: Phonak Audéo B90-Direct|Hearing aids will be fitted to the participants individual hearing loss.
15886395|NCT03755440|Drug|PD-1 antibody (SHR-1210)|PD-1 antibody (SHR-1210), 200mg, ivdrip, every 2 weeks.
15886396|NCT03755427|Biological|15μg H7N9 Vaccine|The vaccine was a inactivated, whole virion preparation of the influenza A/Shanghai/2/2013(H7N9) virus, propagated in embryonated chicken eggs，mixed with aluminum hydroxide adjuvant.
15886397|NCT03755427|Biological|Aluminum Hydroxide Adjuvant|The seasonal influenza vaccine was a inactivated, split virion preparation of the influenza virus, propagated in embryonated chicken eggs. The aluminum hydroxide adjuvant was 0.5ml aluminum hydroxide adjuvant.
15886398|NCT03755414|Procedure|Stem cell transplantation|Standard of care
15886399|NCT03755414|Drug|Itacitinib|Itacitinib may be taken without regard to food.
15886400|NCT03755414|Other|Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT)|"Screening, day 14, day 28, day 42, day 74, day 100, taper period, and follow-up (pilot study)
~Screening, day 14, day 28, day 42, day 60, day 74, day 100, day 180, taper period, and follow-up period (expansion study)"
15886401|NCT03755414|Other|Human Activity Profile|"Screening, day 14, day 28, day 42, day 74, day 100, taper period, and follow-up (pilot study)
~Screening, day 14, day 28, day 42, day 60, day 74, day 100, day 180, taper period, and follow-up period (expansion study)"
15886402|NCT03755401|Other|TFPP|Trauma-Focused Psychodynamic Psychotherapy
15886403|NCT03755401|Other|TAU|treatment as usual at the VA for PTSD
15886404|NCT03755388|Device|Episealer|Placing Episealer device
15886405|NCT03755375|Device|E-stim|SEMG Biofeedback applied for relaxation, trigger points release and E-stim to decrease pelvic pain
15886406|NCT03755375|Behavioral|Postural exercises|SEMG Biofeedback applied for relaxation, trigger points release and postural exercises to improve pelvic mobility to decrease the pelvic pain
15886407|NCT03755362|Procedure|Standard Treatment|Dental evaluation at baseline, 3, 6, and 9 months.
15886408|NCT03755362|Procedure|Intensive Treatment|Dental evaluation at baseline, 3, 6, and 9 months. Plus one or more sessions as needed at baseline of full mouth supra- and sub-gingival scaling and root planing, plus oral hygiene instruction. Additional sessions as necessary to remove remaining local factors and treat inflammation and bacteria overgrowth. Additional evaluations and therapy at 2 months or as needed based on therapeutic response. If bleeding on probing levels do not decrease to <20% of sites following initial therapy or at subsequent visits, intermediate treatment visits will be scheduled. Each participant will be instructed to use half of a capful of 0.12% chlorhexidine twice a day during active treatment including two weeks beyond the treatment visit.
15886409|NCT03755349|Device|Placement of burr-hole covers|Placement of a burr-hole cover (Stryker® UN3 BURR HOLE COVER, 20mm, W/TAB, Item code 53-34520) fixed with 2 screws (Stryker® UNIII AXS SCREWS, SELF-DRILLING, 1.5 x 4MM, Item code 56-15934) on each of two burr-holes
15886410|NCT03755349|Other|No placement of burr-hole covers|In the control group, none of the burr-holes is covered, representing our current standard of care. In patients with bilateral cSDH, none of the burr-holes on the control side are covered with burr-hole covers.
15886411|NCT03755336|Other|Administered Slip Perturbations|Slips will be administered in early, middle or late phases of stance during overground walking.
15886412|NCT03755310|Drug|Suvorexant|First week: 10 mg tabs; Second week: 10-20 mg tabs
15886413|NCT03755310|Drug|Placebo|Equivalent dosage, route of administration and dose regimen
15886414|NCT03755297|Other|Blood sample analysis of patients treated as standard care|Blood sample to analyse percentage of blood cells (regulatory B cells et T cells)
15886415|NCT03755284|Other|Sacral Massage|● In addition to providing them with routine nursing/midwifery care, the women in the experimental group were administered a massage to the sacral region under the supervision of a doctor for 30 minutes using the effleurage (patting) ( 15 minutes) and vibration technique ( 15 minutes) in the latent (3-4 cm), active (5-7 cm) and transition (8-10 cm) phases of labour. To achieve this, the patients were placed in the left lateral position in the latent (3-4 cm), active (5-7 cm) and transition (8-10 cm) phases of labour.
15886416|NCT03755258|Drug|GCK 100 mg + Placebo 200 mg|GCK 100 mg + Placebo 200 mg, oral, 12 weeks
15886417|NCT03755258|Drug|GCK 200 mg + Placebo 100 mg|GCK 200 mg + Placebo 100 mg, oral, 12 weeks
15886418|NCT03755258|Drug|GCK 300 mg|GCK 300 mg, oral, 12 weeks
15886419|NCT03755258|Drug|Placebo 300mg|Placebo 300mg, oral, 12 weeks
15886420|NCT03755245|Other|[68Ga]Ga-DOTA-Siglec-9|Vascular Adhesion Protein 1 (VAP-1) targeted radiopharmaceutical
15886421|NCT03755232|Dietary Supplement|scFOS|Fossence™ (short chain Fructo-oligosaccharides (scFOS)
15886422|NCT03755232|Other|Control|water or dextrose or white bread
15886423|NCT03755219|Procedure|TEP|By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device
15886424|NCT03755219|Procedure|TAPP|By laparoscopic (keyhole) approach, the hernia is repaired with a plastic mesh which the surgeon may or may not anchor with some sort of fixation device
15886425|NCT03755206|Other|Sustainability strategies|The investigators will work with each site to determine strategies that are relevant locally to help promote sustainability of the suicide prevention program.
15886426|NCT03755193|Drug|"SERM Viviant®Tablet 20mg and ELD Edirol®Tablet 0.75ug"|To examine the effects of SERM and ELD in osteoporosis patients
15886427|NCT03755193|Drug|"Bisphosphonates and ELD Edirol®Tablet 0.75ug"|To examine the effects of BP and ELD in osteoporosis patients
15886428|NCT03755193|Drug|"ELD Edirol®Tablet 0.75ug"|To examine the effects of ELD in osteoporosis patients
15886429|NCT03755180|Other|Exercise Training|In exercise training, aerobic exercise and strengthening exercises, especially for gastrocnemius and tibialis anterior muscles, will be applied to the patients. In addition the exercise training, Compression Therapy is applied to patients.
15886430|NCT03755180|Other|Compression Therapy|Compression therapy is a treatment applied to patients in the form of Four Layer Compression Bandage and Compression Stocking. Four Layer Compression Bandage is a treatment that requires four different types of bandages. The compression stocking is an elastic stock with various tension and length.
15886431|NCT03755167|Drug|IPL344|IPL344 will be administered by intravenously (IV) infusion once a day (every 24±6 hours), using a Peripherally Inserted Central Catheter (PICC) line or a permanent port. IPL344 will be administered using an electronic pump at a flow rate that will be determined in protocol 101/2. The dose will be fixed as MTD as established in protocol 101/2 (up to 3.2 mg/kg).
15886432|NCT03755154|Drug|S65487- initial scheme|S65487 is administered as single agent via i.v. infusion on a 3-week cycle.
15886433|NCT03755154|Drug|S65487 - alternative scheme|S65487 is administered in 3 infusion in the first week of cycle 1, via i.v. infusion over 30 minutes.
15886434|NCT03755141|Drug|Herzuma|Herzuma + Treatment of Physician's Choice
15886436|NCT03755115|Drug|Epirubicin plus SHR1210|First intravenous injection of epirubicin injection, D1,30mg/m^2 Then intravenous administration with SHR-1210,D1, a fixed dose of 200mg, 30min per infusion, Q2W. The total dose of epirubicin is 360 mg/m^2.next SHR-1210 single drug maintenance .Until to secdonary disease progression or intolerance side effects.Evaluate efficacy every 3 cycles.
15886437|NCT03755102|Drug|Dacomitinib|"Cohort 1 Dacomitinib Dosing:
~Dose level 1: Dacomitinib 45mg daily Dose level -1: Dacomitinib 30mg daily Dose level -2: Dacomitinib 15mg daily
~Cohort 2 Dacomitinib Dosing:
~Dose level 1: Dacomitinib 30 mg daily Dose level -1: Dacomitinib 15 mg daily"
15886438|NCT03755102|Drug|Osimertinib|"In cohort 2, participants will begin on dacomitinib orally daily in combination with Osimertinib
~Dose level Osimertinib Dosing:
~Dose level 1: Osimertinib 80 mg daily Dose level -1: Osimertinib 40 mg daily"
15886439|NCT03755089|Drug|Phenazopyridine|200mg PO Phenazopyridine taken 1-2 hours prior to the Botox® injection procedure
15886440|NCT03755089|Drug|Lidocaine 2% Injectable Solution|30mL 2% lidocaine instilled into the bladder lumen 20 via a urinary catheter 20 minutes prior to the Botox® injection procedure
15886441|NCT03755076|Behavioral|Perceptual cuing|The two perceptual cues are: (a) feedback about the time-lag between the two arms presented as a horizontal tilt of the common goal, and (b) different movement weighting coefficients to each arm to force greater movement contribution of the paretic arm in a bimanual context.
15886442|NCT03755063|Other|Speech therapy apps|Speech therapy apps loaded on tablets
15886443|NCT03755050|Other|general and specific data|General and specific data collected
15886444|NCT03755037|Drug|Clomid, Respatio and Ethinyl estradiol|Drugs were received during the menstrual cycle.
15886445|NCT03755024|Device|ultrasound|"The compulsory ultrasound measurements to be obtained at all visits include the following biometrical parameters:
~Biparietal diameter
~Head circumference
~Abdominal circumference
~Femur length
~Humerus length"
15886446|NCT03755011|Device|white noise|Patients in the interventional arm will have white noise (through in-room workstations- on-wheels and publicly-available white noise websites) playing overnight at a standardized volume to be determined.
15886448|NCT03754998|Behavioral|Intervention Group|The participating dyads in intervention communities were invited to consume veo soup/meal (HSM) three times a week and provided weekly supply of iodized salt (450 g) for the household usage as well as being engaged in dry season container gardening. The veo soup/meal is a local Ghanaian soup/meal mainly made of Hibiscus Sabdarifa leaves. It is a soup when prepared a bit watery and consumed with 'tou zaafi' (millet or corn based cooked paste). It is also a meal when prepared thick and eaten by itself. The Hibiscus Sabdariffa leaves meal (HSM) used in the present study was made of 18 kg Hibiscus Sabdariffa leaves, 8 kg groundnut, 1.1 kg dawadawa (fermented African locust beans), 3 kg dried fish plus 0.045 kg iodized salt, cooked with about 23 L (23 kg) water to yield 52.5 kg HSM. In each community, groups of ten women took turns to share the cooking activities, washing of bowls, and making water available for cooking. No treatment provided in our control communities.
15886449|NCT03754985|Device|Hyperbaric oxygen therapy|"The study included participants 18 years or older, scheduled for 60 HBOT sessions for any indication.
~After signing an informed consent form, the participants underwent a pulmonary function baseline evaluation. Participants were treated in a multiplace chamber (HAUX-Life-Support GmbH) for 60 daily sessions, 5 days a week. Each session consisted of 90 minutes of exposure to 100% oxygen at 2 ATA with 5 minute air breaks every 20 minutes. Participants repeated their pulmonary function evaluation after the last HBOT session.
~After signing an informed consent form, the participants underwent a pulmonary function baseline evaluation. Participants were treated in a multiplace chamber (HAUX-Life-Support GmbH) for 60 daily sessions, 5 days a week. Each session consisted of 90 minutes of exposure to 100% oxygen at 2 ATA with 5 minute air breaks every 20 minutes. Participants repeated their pulmonary function evaluation after the last HBOT session."
15886450|NCT03754972|Diagnostic Test|Sagittal plane shear index (SPSI)|Report SPSI to surgeon after surgeon records an initial surgical plan, and determine whether the objective spinal stability metric influences a change in the surgical plan.
15886451|NCT03754959|Drug|BI 1358894|Film-coated tablet
15886452|NCT03754959|Drug|Placebo|Film-coated tablet
15886453|NCT03754959|Drug|Midazolam|Solution for injection
15886454|NCT03754933|Biological|Ad/PNP|Ad/PNP is a replication defective adenoviral vector expressing E. coli Purine Nucleoside Phosphorylase
15886455|NCT03754933|Drug|Fludarabine Phosphate|Fludarabine phosphate is an anticancer agent currently used to treatment patients with chronic lymphocytic leukemia.
15886456|NCT03754920|Behavioral|prolonged fasting|"Fasting for 5 days: Fasting with some fitness regimen, such as meditation and mild physical exercise;
~Feeding for 3 days: Gradually distribute participants with rice flour, porridge and juice."
15886457|NCT03754907|Procedure|Endocutter stapler|Endocutter ETS 35, ETS Flex 45 stapler, and the Echelon Flex Powered ENDOPATH Stapler with 2.5- or 3.5-mm staples (Johnson & Johnson K.K., Tokyo, Japan)
15886458|NCT03754907|Procedure|suture material|absorbable suture material is used to perform hand-sewn anastomosis in an end-to-end manner.
15886459|NCT03754894|Device|ready made plastic stent application|full / partial thickness apically repositioned flap with paracrestal lingual incision will be performed for implant placement followed by healing abutment placement covered by ready-made plastic stent.
15886460|NCT03754894|Procedure|simple interrupted sutures|full / partial thickness apically repositioned flap with paracrestal lingual incision will be performed for implant placement followed by healing abutment placement and securing the flap with simple interrupted sutures
15886461|NCT03754881|Behavioral|Pulmonary rehabilitation|"In this study, we'll educate pulmonary rehabilitation to patients and make reservation for re-visiting outpatients clinics with PR diary after 8 weeks.
~we want to confirm whether patients, who perform home based PR during more than 30 minutes in 3 days per week, present improved dyspnea score or quality of life compared with non-compliance group."
15886462|NCT03754868|Diagnostic Test|Detailed coagulation monitoring|Monitoring of coagulation using activity of coagulation factors, rotational thrombelastometry and multiple electrode aggregometry
15886463|NCT03754855|Behavioral|Questionnaire|Questionnaire
15886464|NCT03754842|Other|Placebo (twice daily)|Matching placebo
15886465|NCT03754842|Other|Nicotinamide Riboside/Pterostilbene (500 mg/100 mg twice daily)|Elysium Basis TM, Elysium Health, Inc., NY, USA
15886466|NCT03754829|Behavioral|Her Sey Kontrol Altinda (HSKA)|HSKA consists of 5 sessions over 5 weeks and is based on Problem-Solving therapy. Participants receive feedback on their homework assignments in brief weekly online messages from a clinical psychologist.
15886467|NCT03754816|Procedure|PECS II and parasternal block|10 ml of Levobupivacaine 0.375% injected between minor and major pectoralis muscles. 20 ml of Levobupivacaine 0.375% injected between minor and serratus muscles. 10 ml of Levobupivacaine 0.375% injected between major and intercostal muscles at II and IV intercostal space.
15886468|NCT03754816|Drug|Levobupivacaine|Levobupivacaine
15886469|NCT03754803|Other|HIV Symptom Distress Module Questionnaire|The Symptom Distress Module is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment.
15886470|NCT03754803|Other|HIV treatment satisfaction questionnaire|The HIV TSQ is a 10-item-self-reported scale that measures overall satisfaction with treatment and by specific domains e.g., convenience and flexibility.
15886471|NCT03754790|Drug|Fitusiran|Pharmaceutical form:solution for injection Route of administration: subcutaneous
15886472|NCT03754777|Procedure|Laparoscopic appendectomy|"Preoperative care in both arms. Crystalloid isotonic solutions and antibiotic prophylaxis 30 min prior to surgery.
~Surgery. General anesthesia with strict control of fluid therapy and hemodynamic changes during surgery. Appendectomy with the use of monopolar coagulation by experienced surgeons following appendix stump ligation by two Roeder knots.
~Postoperative care. Antibiotics for 3-5 days for patients with complicated appendicitis (Gomez ≥ 3A). The postoperative pain level evaluation in rest by VAS in 0 h (immediately after awakening), 2, 6, 12 and 24 h postop. The postoperative analgesic modality on demand: Ketorolac 30 mg for patients with VAS pain level ≥ 5 cm. Antiemetics in dyspepsia. No iv infusions postoperatively. Intestinal peristalsis evaluation by auscultation every 2 h after surgery."
15886473|NCT03754764|Biological|Specificity CD38 CAR-T Cells|1) Biological: Specificity CD38 CAR-T Cells 2) Day 0: 1-5x10e6/kg total dose .3) Other: Laboratory Biomarker Analysis
15886540|NCT03754218|Drug|Amnion Membrane Powder|This sterilized product is composed of lyophilized, gamma-irradiated powder made from amniotic membrane for topical application with the purpose of enhanced wound healing.
15897709|NCT03667937|Combination Product|CUTIMED|Hydrophobic Dressing
15886474|NCT03754751|Procedure|Laparoscopic cholecystectomy with the implementation of modified ERAS program|"Preoperative Crystalloid isotonic solutions and antibiotic prophylaxis 30 min prior to surgery.
~1) Patient informing and brochure
~Surgery Cholecystectomy using monopolar by experienced surgeons under general anesthesia
~Low-pressure pneumoperitoneum (8-9 mmHg)
~Trocar wound and intraabdominal anesthesia with 0.25% ropivacaine
~PONV prophylaxis in patients of risk
~Postoperative care
~Early mobilization (2 h after surgery)
~Early fluid intake (2 h after surgery)
~Early liquid food (6 h after surgery) Antibiotics for 3-5 d for patients with complicated cholecystitis (TG13 2). The postoperative pain level evaluation in rest by VAS in 0 h (immediately after awakening), 6 h and 24 h postop. The postoperative analgesic modality on demand: Ketorolac 30 mg for patients with VAS pain level ≥ 5 cm. Antiemetics in dyspepsia. No iv infusions postoperatively. Intestinal peristalsis evaluation by auscultation every 2 h after surgery"
15886475|NCT03754751|Procedure|Laparoscopic cholecystectomy with standard perioperative treatment|"Preoperative Crystalloid isotonic solutions and antibiotic prophylaxis 30 min prior to surgery.
~1) Patient oral informing. No brochure
~Surgery Cholecystectomy using monopolar by experienced surgeons under general anesthesia
~Standard CO2 pressure (12-14 mmHg)
~No additional anesthesia
~Postoperative care
~Mobilization in 4-6 h after surgery
~Fluid intake in 6 hours
~Liquid food intake in 12 hours Antibiotics for 3-5 d for patients with complicated cholecystitis (TG13 2). The postoperative pain level evaluation in rest by VAS in 0 h (immediately after awakening), 6 h and 24 h postop. The postoperative analgesic modality on demand: Ketorolac 30 mg for patients with VAS pain level ≥ 5 cm. Antiemetics in dyspepsia. No iv infusions postoperatively. Intestinal peristalsis evaluation by auscultation every 2 h after surgery"
15886476|NCT03754738|Device|Balloon guide catheter|Use a balloon guide catheter in the mechanical thrombectomy
15886477|NCT03754738|Device|Non-balloon guide catheter|Use a non-balloon guide catheter in the mechanical thrombectomy
15886478|NCT03754725|Drug|Deferiprone pill|1000 mg of deferiprone (oral) BID (15 mg/Kg)
15886479|NCT03754725|Drug|placebo|patients will receive placebo orally
15886480|NCT03754725|Behavioral|Montreal Cognitive Assessment|Neurocognitive assessment, lower score indicates lower cognitive level
15886481|NCT03754712|Dietary Supplement|Vitamin D3|Dietary supplement : Vitamin D3 one tablet of vitamin D3 (2000IU) per day for 8 weeks
15886482|NCT03754699|Behavioral|Educational intervention|"During the usual pre-anesthesia assessment (performed between D-30 and D0 of the intervention), the anesthesiologist will deliver to the intervention group patient oral and visual information on:
~the numerical scale of pain ranging from 0 to 10 with examples of perceptions corresponding to each level of the scale (calibration)
~nature of postoperative pain (inflammatory character, dynamic over time)
~average pain level incurred by the intervention
~the difference between anti-inflammatory and opioid analgesics
~principles of systematic treatment and pain anticipation
~principles of overdose and side effects prevention This information is standardized and delivered orally, accompanied by a visual support (patient diary), which will be given to the patient upon discharge from the hospital"
15886483|NCT03754699|Behavioral|Standard information|Standard information on pain For patients in the control group the standardized information is based on the SG/DGM/DSS 1/41-2010 scheme of the AFSSAPS-CFETD repository.
15886484|NCT03754686|Drug|Oseltamivir|Best medical care and oral oseltamivir 75 mg twice daily for five days. Dose adjustments of oseltamivir will be made according to manufacturer's instructions.
15886485|NCT03754686|Drug|Paracetamol|Best medical care and oral paracetamol twice daily for five days
15886486|NCT03754673|Device|MRI|MRI pulmonary with no contrast administration
15886487|NCT03754660|Drug|BAY1237592|Oral inhalation with dry powder inhaler, single dose.
15886488|NCT03754660|Drug|PH-monotherapy|Any kind of monotherapy for PAH/CTEPH with the exception of inhaled Iloprost. Known vasoresponders are excluded.
15886489|NCT03754660|Drug|PH-combination therapy|Any kind of double or triple combination treatment for PAH/CTEPH with the exception of inhaled Iloprost. Known vasoresponders are excluded.
15886490|NCT03754660|Procedure|NO gas|Inhaled NO (nitric oxide) given for vasoreagibility testing as part of the standard right heart catheterization diagnostic procedure.
15886491|NCT03754647|Dietary Supplement|Vitamin C|One tablet of Vitamin C (500 mg) twice daily with SSRIs for 8 weeks
15886492|NCT03754634|Drug|Eltrombopag and Diacerein|The initial dose of eltrombopag administration is 25 mg orally once daily, which could be transited to 50 mg/d in a 2-week cycle according to the need, and the maximum dose was not more than 75 mg/d. The dose of diacerein administration is 50 mg orally twice daily. The treatment was discontinued after 6 weeks without blood index reaction.
15886493|NCT03754621|Diagnostic Test|Serum thyroid functions tests|Serum TSH, fT3, fT4 and anti-TPO
15886494|NCT03754608|Diagnostic Test|MRI including cf-MRI, DTI, ASL and CVR.|A paradigm developed at Yale University called Cognitive Predictive Modelling which takes connectivity data and reduces it to two smaller network which predict higher and lower performance in a particular task for which these networks have been optimized. This will be supplemented by MRI vascular measures.
15886495|NCT03754595|Procedure|3D Laparoscopic pancreatoduodenectomy|Patients with pancreatic cancer treated by 3D Laparoscopic pancreatoduodenectomy
15886496|NCT03754595|Procedure|2D Laparoscopic pancreatoduodenectomy|2D Laparoscopic pancreatoduodenectomy
15886497|NCT03754582|Drug|Perampanel|Oral tablets.
15886498|NCT03754582|Drug|Perampanel|Intravenous infusion.
15886499|NCT03754569|Procedure|Peritoneal biopsies after complete macroscopic cytoreduction|We will perform at the end of complete macroscopic cytoreductive surgery (CC-0) for epithelial ovarian cancer random peritoneal biopsies in apparently healthy peritoneum in order to assess the presence of microscopic peritoneal metastases
15886500|NCT03754556|Device|Intrauterine device|Intrauterine devices, e.g. BAY86-5028 (Mirena, Skyla, Kyleena), Liletta and ParaGard
15886501|NCT03754543|Other|Labeled iron salt Fe54|Ferrous fumarate enriched with Fe 54 isotopes contains 2.25 mg of iron source and 13.5 mg of Vitamin C per serving
15886502|NCT03754543|Other|Labeled iron salt Fe57|Ferrous fumarate enriched with Fe 57 isotopes contains 2.25 mg of iron source and 13.5 mg of Vitamin C per serving
15886503|NCT03754543|Other|Labeled iron salt Fe58|Ferrous bisglycinate enriched with Fe 58 isotopes contains 2.25 mg of iron source and 13.5 mg of Vitamin C per serving
15886504|NCT03754530|Drug|Icotinib|orally three times per day
15886505|NCT03754530|Radiation|WBRT or SRS|>3 with WBRT;<=3 with SRS
15886506|NCT03754517|Diagnostic Test|RPR Titer|RPR titer; TPPA/FTA-ABS; Next-Generation Sequencing
15886510|NCT03754478|Other|Physical activity training|subjects will enter a 3-month supervised physical activity program during which they will take part to supervised and unsupervised physical activity sessions. Type of physical activity will be selected among a number of available activities (aquagym, aerobics, resistance training, outdoors activities) based on individual needs and preferences); it will consist in 2 weekly supervised activity sessions during which participants will be instructed by a specialist in adapted physical activity, and 2-3 weekly session of unsupervised physical activity which will be performed according to detailed instructions regarding intensity and duration.
15886511|NCT03754465|Biological|ALLO-ASC-DFU|Application of ALLO-ASC-DFU Sheet to diabetic foot ulcer
15886512|NCT03754465|Procedure|Hydrogel SHEET(Vehicle control)|Application of Hydrogel SHEET to diabetic foot ulcer
15886513|NCT03754439|Behavioral|Physiological changes to noise and vibration exposure|Physiological parameters (HR, RR, Sats, NIRS) will be observed during a period of stay on the neonatal unit (Inborn group) or during ambulance transportation (Transported group) whilst simultaneous measurement of noise and vibration exposure. Urine will be collected during the first 24, 48 and 72 hours post exposure for biochemical markers of brain injury (S100B) and stress (Cortisol)
15886514|NCT03754426|Device|Fluorescence Imaging Device|Hand-held, real-time fluorescence imaging device
15886515|NCT03754413|Device|experimental|Neuramis® Deep Lidocaine
15886516|NCT03754413|Drug|comparator|No-treatment
15886517|NCT03754400|Biological|Albumin|All patients will receive a daily intravenous infusion of 20% Human Albumin Solution (HAS) 40 gram at day 0 (loading dose), Day-1 to day 7, 20 gm daily, then from day 8 to day 28, 20 gm every alternate day.
15886518|NCT03754400|Other|Standard Medical Treatment|Antibiotics, nutrition and supportive treatment
15886519|NCT03754387|Drug|Ceftazidime|Patients choosing AT group were admitted to the hospital for observation and to receive intravenous antibiotics Intravenous Ceftazidime sodium (50mg/kg/dose every 12 hours) was administered for 3 days.
15886520|NCT03754387|Procedure|appendectomy|APPT group consisted of admission to the hospital with promptinitiation of intravenous antibiotics and appendectomy
15886521|NCT03754374|Other|access to healthcare|use or non-use of dedicated health facilities
15886522|NCT03754361|Procedure|automated peritoneal dialysis|peritoneal dialysis administered by a cycler
15886523|NCT03754361|Procedure|IHD|HD 4hour 2-3times per week
15886524|NCT03754348|Radiation|PET scan with tracer injection [18F] DPA-714|the subject will receive a dose of 3.5MBq / kg intravenous (in bolus) more or less 20%, knowing that the minimum dose injected is unchanged at 150MBq and the maximum dose at 370 MBq. Irradiation will remain below 10 mSv
15886525|NCT03754335|Procedure|Lumbar puncture|"Patient will be managed according to the current international recommendations in the Toulouse acute stroke center.
~In the absence of clear recommendation in the literature headache will be treated according to our local predefined analgesic protocol: paracetamol 1g/6 h, and if the numerical scale ≥ 4 : continuous intravenous morphine starting at 1mg/h and increased per 0.5 mg/h every hour if numerical scale remains ≥ 4.
~Lumbar puncture will be performed between day 3 and day 5 after subarachnoid hemorrhage onset by an independent scientist from our clinical investigator center. 30-mL CSF will be removed by LP.
~Sham LP consisting in superficial skin puncture by a subcutaneous needle (27 gauge needle) during the usual procedure will be performed at the same time point."
15886526|NCT03754322|Diagnostic Test|LAMP|LAMP testing involves taking a blood specimen using venous puncture, extracting DNA and performing a commercial CE-marked LAMP malaria assay to obtain a malaria result (presence/absence of parasite DNA) at the species level
15886527|NCT03754322|Diagnostic Test|Microscopy/RDT|Standard of care management of malaria in pregnancy relies on microscopy and/or RDT for diagnosis
15886528|NCT03754309|Drug|KY1005|A human anti-OX40 ligand monoclonal antibody
15886529|NCT03754309|Drug|Placebo|Matched placebo
15886530|NCT03754296|Device|CATCHVIEW|Revascularization device
15886531|NCT03754283|Device|Indirect bonding|Indirect bonding is the technique where orthodontic appliances are first placed on a model of the patient and then transferred to the patient using some kinf of trays
15886532|NCT03754270|Other|Advice in lifestyle|Patients with moderate OSA according to a baseline nocturnal respiratory registration (NRR). Patients receive instructions and advice on lifestyle according to current clinical practice. Life style advice is quite subjective and it means that the patients are encouraged to stop smoking, to avoid alcohol, to lose weight, to be more physically active and to avoid sleeping on supine position.Patients fill in questionnaire 1 that includes questions about nocturnal respiratory disturbances, daytime sleepiness, insomnia, use of tobacco and alcohol, comorbidity and medication. After 6+/-2 weeks of treatment, patients fill in Questionnaire 2 which contains the same questions as Questionnaire 1 and also questions about any side effects, evaluation of treatment. In conjunction with visit 2 another NRR will be performed.
15886533|NCT03754270|Device|Cervical collar|"Patients with moderate OSA according to a baseline nocturnal respiratory registration (NRR). Patients receive the same instructions and advice as in Arm lifestyle advice and also get a CC and instructions on how to sleep with it. CC is marketed for indications of various diseases such as traumatic cervical injury, cervical disc herniation and other neck problems and allows adjustment of the elevation level to achieve sufficient effect, i.e., extending the neck.Patients fill in questionnaire 1 that includes questions about nocturnal respiratory disturbances, daytime sleepiness, insomnia, use of tobacco and alcohol, comorbidity and medication. After 6+/-2 weeks of treatment, patients fill in Questionnaire 2 which contains the same questions as Questionnaire 1 and also questions about any side effects, evaluation of treatment. In conjunction with visit 2 another NRR will be performed."
15886534|NCT03754257|Procedure|High-frequency Electrical Stimulation|High Electrical Stimulation (75Hz) during 40 minutes
15886535|NCT03754257|Procedure|Sham Electrical Stimulation|Sham Electrical Stimulation (5Hz) during 40 minutes
15886536|NCT03754257|Other|Conventional Physiotherapy|Active and passive exercises, and walking.
15886537|NCT03754244|Drug|TQB3456|Observe the safety and pk when the subjects take TQB3456 p.o. qd
15886538|NCT03754231|Other|Heart rate monitoring|"The heart rate of recruited patients will be monitored for 15 minutes over 2 phases:
~i) 10 minutes at rest ii) 5 minutes during physical activity in the form of walking or playing"
15886539|NCT03754231|Other|Respiratory rate monitoring|"The heart rate of recruited patients will be monitored for 15 minutes over 2 phases:
~i) 10 minutes at rest ii) 5 minutes during physical activity in the form of walking or playing"
15886542|NCT03754205|Device|Microablative Fractional CO2 laser|3 therapies intravaginally administered will be applied at monthly intervals
15886543|NCT03754192|Radiation|perfusion Computed Tomography|Will be carried before liver surgery
15886544|NCT03754179|Drug|Dabrafenib|"Upfront treatment with dabrafenib, trametinib and hydroxychloroquine in phase 1 and Arm A phase 2.
~Upfront treatment with dabrafenib and trametinib in Arm B phase 2 with add-on of hydroxychloroquine at progression of disease"
15886545|NCT03754179|Drug|Trametinib|"Upfront treatment with dabrafenib, trametinib and hydroxychloroquine in phase 1 and Arm A phase 2.
~Upfront treatment with dabrafenib and trametinib in Arm B phase 2 with add-on of hydroxychloroquine at progression of disease"
15886546|NCT03754179|Drug|Hydroxychloroquine|Upfront treatment with dabrafenib, trametinib and hydroxychloroquine in phase 1 and Arm A phase 2. Add-on at progression of disease in Arm B phase 2
15886547|NCT03754166|Other|Constraint-induced movement therapy|"Patient's unaffected arm is restrained, by a glove including thumb, during activities of daily life (bathing, grooming, dressing and feeding = approx. 4h/day).
~Visual spatial cueing is displayed in the bedroom and the bathroom."
15886548|NCT03754153|Device|Balanced Binocular Viewing (BBV)|The dose of BBV therapy will be one hour a day or 2x30 min/day (depending on child's attention span and/or need to implement the treatment around the family daily routine).
15886549|NCT03754153|Other|Standard Therapy - Occlusion (patching) or blurring (atropine)|The prescribed dose of occlusion treatment / patching (parental choice) will depend on the severity of amblyopia, as by current clinical practice based on PEDIG studies
15886550|NCT03754140|Drug|Polidocanol Injection|Sclerotic agent
15886551|NCT03754127|Device|tDCS|Transcranial direct current stimulation
15886552|NCT03754127|Device|sham tDCS|Sham transcranial direct current stimulation
15886553|NCT03754114|Other|ICP + PbtO2 guided management strategy|In this management strategy, the physiological goal is to avoid ICP from exceeding 22 mm Hg and to avoid PbtO2 dropping below 20 mm Hg. ICP and PbtO2 are monitored using devices inserted into the brain through a hole in the skull. These devices are approved by the US Food and Drug Administration (FDA) and Health Canada for patients with severe TBI. The devices are used in standard care at hospitals participating in this research study. Doctors adjust their treatment choices to try to achieve these ICP and PbtO2 goals. Treatments include kinds and doses of medications and the amount of intravenous fluids given, ventilator (breathing machine) settings, need for blood transfusions, and other medical care. This management strategy is used to guide care for 5 days in this research study.
15886554|NCT03754114|Other|ICP guided management strategy|In this management strategy, the physiological goal is to avoid ICP from exceeding 22 mm Hg. ICP and PbtO2 are monitored using devices inserted into the brain through a hole in the skull, but PbtO2 is not used to guide care. These devices are approved by the US Food and Drug Administration (FDA) and Health Canada, and are routinely used in patients with severe TBI. Doctors adjust their treatment choices to try to achieve this ICP goal. Treatments include kinds and doses of medications and the amount of intravenous fluids given, ventilator (breathing machine) settings, need for blood transfusions, and other medical care. This management strategy is used to guide care for 5 days in this research study.
15886555|NCT03754075|Procedure|Complete mesocolic excision|The resection was based on the principles of CME. The superior mesenteric vein was exposed to perform central vessel ligation and lymph nodes dissection. Extended right hemicolectomies for tumors located from the ascending colon close to the hepatic flexure and distally were performed openly as standard during the study period. These resections included the prepyloric and gastroepiploic lymph nodes dissection.
15886556|NCT03754075|Procedure|Conventional colon resections|The patients underwent what was considered standard colon cancer resections in Denmark during the study period.
15886557|NCT03754062|Drug|Placebo - Cap|Administration of Placebo by pill.
15886558|NCT03754062|Drug|L-dopa|Administration of L-dopa by pill.
15886559|NCT03754062|Drug|Haloperidol|Administration of Haloperidol by pill.
15886560|NCT03754049|Drug|TLC599|TLC599 is manufactured with the proprietary lipid formulation in lyophilized form (BioSeizer) for the reconstitution with the aqueous DSP (active ingredient).
15886561|NCT03754049|Drug|DSP|Dexamethasone sodium phosphate (DSP) is a glucocorticoid widely used in the treatment of joint pain such as gout, osteoarthritis and rheumatoid arthritis via IA injection.
15886562|NCT03754036|Behavioral|Sleep manipulation|Participants will sleep their typical amount at home for 1 week and will then be randomized to either increase or decrease their time in bed by 1.5 hours per night for 1 week, completing the alternate schedule on the fourth week (washout period of 1 week between sleep conditions). This procedure will result in a targeted 3-hour time in bed difference between conditions. Sleep will be objectively measured using actigraphy (Actiwatch) and sleep schedule adherence will be promoted by providing fixed bedtimes and wake times during the experimental weeks, and will be monitored through phone calls to the research center.
15886563|NCT03754023|Diagnostic Test|Urine-TIMP-IGFBP7 biomarker for AKI|Urine-TIMP-IGFBP7 biomarker for AKI
15886564|NCT03754010|Procedure|Scaling and root planning|Under local anesthesia, full-mouth SRP will be performed by a single investigator. Immediately after the SRP, HA gel or mouthrinse will perform according to the groups' procedure. In Group 1, the periodontal sulcus will be irrigated with saline solution after SRP.
15886565|NCT03754010|Drug|Hyaluronic acid gel (HA) and SRP|In Group 2, after SRP will be performed and irrigated with saline the area was dried with a soft air and, then, a gel containing HA will be applied intrasulcular.
15886566|NCT03754010|Drug|HA mouthrinse and SRP|In Group 3, HA hydrogel mouthrinse will be used as an irrigator after SRP.
15886567|NCT03754010|Drug|HA mouthrinse+gel and SRP|In Group 4, after SRP will be performed, the sulcus was irrigated with HA hydrogel mouthrinse and, then, intrasulculary HA gingival gel will be applied.
15886568|NCT03753997|Behavioral|Treatment by a diabetes educated psychologist|Patients will meet a diabetes educated psychologist. There will be a minimum of 5 meetings during the first 3 months and then in the following 6 months there will be a minimum of 2 meetings. More meetings will be scheduled if needed.
15886569|NCT03753984|Other|Low-level laser therapy|In both arms will be applied Low-level laser therapy and induced muscle fatigue.
15886570|NCT03753971|Other|Sound stimulation|Short sound stimulations will be emitted through a head band during sleep apneas
15886593|NCT03753776|Drug|Radium bromatum pills|Homeopathic Radium bromatum pills will be taken since 48h before radiotherapy and until 15 days after the end of radiation, or until grade 2 or higher radiodermatitis apparition
15886571|NCT03753958|Procedure|Conventional treatment|The treatment will consist of oral hygiene orientation, with brushing technique instructions and daily flossing recommendation. All patients will receive a demonstration of oral hygiene techniques. The calculus deposits on the teeth will be removed with an ultrasound equipment and curettes for root scaling and straightening13. In implants, calculus will be removed with specific curettes for use on the implant surface. Treatment will be performed in 2 to 4 sessions under local anesthesia. Other biofilm-retaining factors, such as carious lesions, condemned teeth and maladaptive restorations, will be removed during these periodontal treatment sessions.
15886572|NCT03753958|Radiation|aPDT|aPDT will be performed after conventional treatment, in sites with pockets greater than or equal to 5 mm. The PapaMblue® photosensitizer with 100 μM methylene blue will be deposited in the pockets with a syringe, with the bottom of the pouch in the coronal direction, and a pre-irradiation time of 1 min will be adopted, so that the PS may stain the entire bacterial biofilm. Then, the laser emitting an wavelength of 660 nm, with power of 100 mW, will be applied. The laser will be applied to the mucosa on the oral epithelium with an optical fiber (apparatus of DMC Therapy EC, São Carlos, Brazil). Irradiation will be performed until the entire peri-implanted pouch is illuminated for 2 minutes at each point. The 6 points around the implant will be irradiated and each irradiation point will present an area of 0.4 cm2, which will result in radiant exposure of 30 J/cm2 following 2 min of irradiation per point. The irradiation will have a constant power density of 250 mW/cm2.
15886573|NCT03753945|Diagnostic Test|MRI of the spine|Perform a clinically indicated MRI of the spine in DBS patients
15886574|NCT03753932|Device|Fixed prosthodontics|The intervention takes place six months after finishing radiotherapy.
15886575|NCT03753919|Drug|Durvalumab|Subjects will be allocated in each primary tumor cohort to receive durvalumab 1500 mg every 4 weeks (Q4W) plus tremelimumab 75 mg Q4W for up to 4 doses during the first 4 cycles of combined therapy. After the first 4 cycles (or before is tremelimumab is stopped due to toxicity), patients will continue to receive durvalumab 1500 mg Q4W until disease progression or unacceptable toxicity. Cycles are defined by 4 weeks or 28 days.
15886576|NCT03753919|Drug|Tremelimumab|Subjects will be allocated in each primary tumor cohort to receive durvalumab 1500 mg every 4 weeks (Q4W) plus tremelimumab 75 mg Q4W for up to 4 doses during the first 4 cycles of combined therapy. After the first 4 cycles (or before is tremelimumab is stopped due to toxicity), patients will continue to receive durvalumab 1500 mg Q4W until disease progression or unacceptable toxicity. Cycles are defined by 4 weeks or 28 days.
15886577|NCT03753906|Device|Osmed® hydrogel expander implantation|Under local anaesthesia, a small vertical incision, adapted to the diameter of the Osmed® sself-inflating hydrogel expander, was made with #15 scalpel blade at the mesial line angle of the adjacent tooth which started below the gingival margin extending from the keratinized tissue above the MGJ to the non-keratinized tissue beyond the MGJ. A minimally invasive preparation of a subperiosteal pouch was performed with KPA tunnelling knife. Size of the pouch was controlled with the specific surgical template to ensure the device easily fits into the prepared pouch without tension. Expanders were secured in the correct position with a bone fixation screw, at the flat end, which does not possess an expansion capability. The wound was closed with 3-0 silk suture using simple interrupted sutures.
15886578|NCT03753893|Other|No intervention used|no intervention used
15886579|NCT03753880|Device|HEMOPATCH Sealing Hemostat|Hemopatch sealing hemostat used after LR to cover the resection surface
15886580|NCT03753867|Drug|Acitretin|Acitretin will be provided to participants in the formulation Soriatane. Soriatane doses are oral tablets taken daily by the participant. Participants will then receive 35mg of oral acitretin (Soriatane) daily for 8 weeks during the intervention phase. Participants will be asked to return two months after completion of the acitretin course for clinical follow-up and additional phlebotomy for laboratory testing.
15886581|NCT03753854|Diagnostic Test|polysomnography and oxygen saturation exam|Measurement of the Apnea/hypopnea index (AHI) and oxygen saturation
15886582|NCT03753854|Biological|calculation of VOC frequency between the first polysomnography and the end of the first year of continuous positive airway pressure treatment|calculation of VOC rate within the two previous years or between first polysomnography and one year of continuous positive airway pressure treatment
15886583|NCT03753854|Biological|Blood samples|Blood samples with measurements of hematological, hemorheological, inflammatory and blood coagulation markers
15886584|NCT03753854|Other|Physiological measurements|Evaluation of microvascular reactivity and autonomic nervous system activity
15886585|NCT03753854|Other|Continuous Positive Airway Pressure|Continuous Positive Airway Pressure during 1 year
15886586|NCT03753841|Other|Adjustment of oral diet|Adjustment of oral diet based on findings in fiberendoscopic evaluation of swallowing (FEES)
15886587|NCT03753815|Device|19G FNA needle|Puncture of AIP under Endoscopic Ultrasonography, with a 19-gauge FNA needle
15886588|NCT03753815|Device|20G FNB needle|Puncture of AIP under Endoscopic Ultrasonography, with a 20-gauge FNB needle
15886589|NCT03753802|Other|Chest Physiotherapy|During sessions, the child is lying on the back, he should not have eaten within two hours prior to the sessions. An extended slow expiration handling is performed on 3 respiratory cycles consecutive, this session is repeated for 10 minutes. Breaks are made regularly during the treatment to have approximately 5 to 6 minutes of handling and 4-5 minutes of rest on the total 10 minutes of treatment. Induced cough handlings will be conducted at five minutes and at ten minutes if the child has not coughed during the movements of chest physiotherapy. These are performed by a brief pressure above the jugular (suprasternal) notch of the patient. Only two consecutive trials of the induced cough handling are allowed, even if the handlings are unsuccessful the physiotherapist does not insist. The following 5 minutes of the session are 5 minutes of rest. During the sessions the physiotherapist wears a mask and respects the usual rules of hygiene.
15886590|NCT03753802|Other|Surveillance|The session is only a surveillance session with the physiotherapist. The physiotherapist is only watching over the child. The parents of the child wait in the waiting room during the physiotherapy session. They don't know which treatment (chest physiotherapy or no treatment) is applied to their child.
15886591|NCT03753789|Device|Microwave Ablation|NEUWAVE microwave ablation of soft tissue liver lesions will be performed percutaneously by an interventional radiologist while the patient is under general anesthesia or deep conscious sedation.
15886592|NCT03753776|Drug|Placebo pills of Radium bromatum|Placebo pills of Radium bromatum will be taken since 48h before radiotherapy and until 15 days after the end of radiation, or until grade 2 or higher radiodermatitis apparition
15886594|NCT03753776|Drug|Radium bromatum/Apis mellifica/Belladonna placebo pills|Placebo pills of Radium bromatum, Apis mellifica and Belladonna will be taken since grade 2 or higher radiodermatitis and until 15 days after the end of radiation
15886595|NCT03753776|Drug|Radium bromatum/Apis mellifica/Belladonna pills|Pills of Radium bromatum, Apis mellifica and Belladonna will be taken since grade 2 or higher radiodermatitis and until 15 days after the end of radiation
15886596|NCT03753763|Drug|Safinamide Methanesulfonate|100 mg (free base)
15886597|NCT03753763|Drug|Safinamide Methanesulfonate matching placebo|100 mg placebo
15886598|NCT03753750|Device|Noninvasive spinal cord stimulation|Noninvasive spinal cord stimulation is a transcutaneous technique used to modulate the activity of the spinal cord. Subjects will undergo sham or actual stimulation 3-4 times a week for one hour at a time.
15886599|NCT03753737|Other|Questionnaires and semi-structured interview|"Questionnaires : PDQ-4+ (personality disorders), HAD (Anxiety and Depression), AUDIT-c (Alcohol consumption), CTQ-SF (Childhood Trauma Questionnaire).
~Semi-structured interview : Evaluation of socio-demographic characteristics, psychiatric and addiction comorbidities, sexually transmitted infections, sexual practices, sexual dysfunction, hypersexual disorder."
15886600|NCT03753711|Procedure|Multifidus muscle biopsy during minimally invasive back surgery|Bilateral biopsy of the multifidus muscle in patient with a unilateral disc hernia.
15886601|NCT03753698|Device|eCoin|"Implantation of device electrodes subcutaneous in lower tibia area;
~Stimulation of posterior tibial nerves:
~Regimen 1 (months 0-3): Six stimulation treatments per week, one stimulation per day, for duration of 30 minutes each Regimen 2 (months 3-6): Three stimulation treatments per week, one stimulation per day, for duration of 30 minutes each. Stimulation is activated by the patient."
15886602|NCT03753685|Drug|X-396(Ensartinib) Capsule|All consented, enrolled, eligible patients receive X-396 capsules, 225mg once daily.
15886603|NCT03753672|Diagnostic Test|preload responsiveness|We investigated whether an increase in CVP ≥ 5 mmHg during PLR predict preload unresponsiveness diagnosed by the absence of increase in velocity-time integral (VTI) of the flow in the left ventricular outflow tract by more than 10%
15886604|NCT03753659|Drug|Pembrolizumab|IV infusion
15886605|NCT03753659|Procedure|Radio Frequency Ablation (RFA)|Local ablation via RFA will be performed via ultrasound- or CT-guided placement of a needle electrode / probe penetrating into the lesion center
15886606|NCT03753659|Procedure|Microwave Ablation (MWA)|Local ablation via MWA will be performed via ultrasound- or CT-guided placement of a needle electrode / probe penetrating into the lesion center
15886607|NCT03753659|Radiation|Brachytherapy|Local ablation via brachythwerapy will be performed via ultrasound- or CT-guided placement of a needle electrode / probe penetrating into the lesion center
15886608|NCT03753659|Drug|Transarterial Chemoembolisation (TACE)|According to Investigator's choice, TACE using drug eluting beads can be performed combined with RFA, MWA or brachytherapy
15886609|NCT03753646|Other|Lactating allowance and psycho social stimulation|Mothers will receive lactating allowance and psycho social stimulation
15886610|NCT03753633|Other|Speech therapy|Oropharyngeal exercises will be performed under the supervision of a speech therapist.
15886611|NCT03753633|Other|Control|Inspiratory and expiratory exercises recruiting diaphragmatic muscles
15886612|NCT03753620|Device|simultaneous fMRI and EEG + peripheral measures|Hemodynamic activity recorded with fMRI, cerebral electric activity recorded with EEG as well as peripheral physiological parameters will be recorded during music listening.
15886613|NCT03753620|Device|EEG and peripheral measures|cerebral electric( with EEG) as well as peripheral physiological parameters will be recorded during music listening.
15886614|NCT03753607|Other|No intervention|No intervention
15886615|NCT03753594|Device|tissue oxygenation saturation|tissue oxygenation saturation
15886616|NCT03753581|Device|Care protocol plus microcurrents|"CARE NURSING PROTOCOL: postural treatment every 4 hours more standardized cure according to the guide of recommendations based on evidence in prevention and treatment of pressure ulcers in adults of Osakidetza health service.
~MICROCURRENTS: the electrodes will be placed on the edge of the dressing on the sides of the ulcer's longer length during 12 hours a day until the ulcer is completely healed or for a maximum of 25 days.
~Characteristics of microcurrents: pulsed monophasic rectangular wave with a pulse of 1.5 s and pause of 300 ms, voltage 21 mV and intensity 42μA with a current density of 4.2 μA."
15886617|NCT03753581|Device|Care protocol plus placebo microcurrents|The same nursing care protocol described for the experimental group will be applied more 12 hours per day of 2 electrodes of microcurrents around the ulcer, which will be previously manipulated and tested with an oscilloscope so that they do not emit electrical currents
15886618|NCT03753568|Device|Electronic medicine reminder system|Electronic surveillance device is attached to the participants push through pill sheet and the smart phone application reminds the participants to take their medicine if they are about to take their daily dosage.
15886619|NCT03753555|Drug|Atorvastatin Calcium|20mg Qd for 12 months
15886620|NCT03753555|Drug|Atorvastatin Calcium|40-80mg Qd for 6 months
15886621|NCT03753555|Drug|Probucol|0.5g Bid for 6 months
15886622|NCT03753542|Other|Multimedia education, booklet Providence and tele-nursing follow-up|Multimedia education, booklet and weekly tele-nursing follow-up is about chemotherapy and side effects management
15886623|NCT03753529|Other|Deep friction massage|Submitted to three session weekly 30-minute sessions of therapy will performed by the administration of sliding and kneading maneuvers of the masseter and temporalis muscles, bilaterally,lateral pterygoid and digastric over four consecutive weeks (total:12 sessions) Sliding consisted of a unidirectional movement in which part of the therapist's hand (mainly the fingertips) will used, moving from the proximal to the distal portion of the face with constant, progressive pressure compatible with the status of each tissue. The degree of pressure varied depending on the level of pain, sensitivity and tension in each individual. Kneading consisted of a gripping maneuver of a muscle group or portion of a muscle.Then follow-up with a passive stretch to the muscle. This will repeated for three to five times for three sessions per week for 4 weeks.
15886647|NCT03753321|Dietary Supplement|Whey protein|Whey protein isolate supplementation, individually adjusted to reach a total protein intake of 1.5 g/kg body weight/day for 10 days (7 days pre-loading and 3 days during trials 1 and 2)
15886648|NCT03753321|Dietary Supplement|Soy protein|Soy protein isolate supplementation, individually adjusted to reach a total protein intake of 1.5 g/kg body weight/day for 10 days (7 days pre-loading and 3 days during trials 1 and 2)
15886624|NCT03753529|Other|Pressure release|First, using a pincer grasp moved throughout the fibers of the pterygoid, masseter, digastric and temporalis muscles to palpate the muscle aiming to locate a trigger point . A common location is detected according to Simon and Travell book. Once located on the trigger point, apply an IC by gradually applying pressure to the trigger point with your thumb. Keep in communication with the patient, checking to ensure that in staying within the limits of his pain tolerance. Hold this technique for approximately 20 seconds to 1 minute, patient tells you that pain has diminished, or until feels the muscle fibers begin to relax under your pressure. Once feel this release, gradually release pressure. All identified trigger points were treated. Then follow-up with a passive stretch to the muscle. This will repeated for three to five times for three sessions per week for 4 weeks.
15886625|NCT03753529|Other|control group|Stretching and transcutaneous electrical nerve stimulation
15886626|NCT03753516|Procedure|Laparoscopic - Vaginal Cuff Closure|All participants are scheduled for either laparoscopic or robotic assisted total hysterectomy. At the end of the hysterectomy the vaginal cuff is closed. In this arm the vaginal cuff will be close laparoscopically using an 0-Barbed suture.
15886627|NCT03753516|Procedure|Vaginal- Vaginal Cuff Closure|All participants are scheduled for either laparoscopic or robotic assisted total hysterectomy. At the end of the hysterectomy the vaginal cuff is closed. In this arm the vaginal cuff will be close vaginally using an 0-Vicryl suture in a vertical fashion.
15886628|NCT03753503|Behavioral|exercise|exercised three times a week in the 8-week HIIT program
15886629|NCT03753503|Behavioral|conventional physical therapy|
15886630|NCT03753490|Other|ABC score guided therapy|In the ABC arm, individual treatment recommendations based on the ABC-scores for stroke and bleeding including non-vitamin K oral anticoagulant or no anticoagulant treatment, and other drugs and interventions, to improve stroke free survival.
15886631|NCT03753490|Other|Standard care|In the standard care arm, management according to local practice, national and international guidelines, including the potential use of traditional clinical risk scores for stroke and/or bleeding, anticoagulant treatment and other treatments and interventions.
15886632|NCT03753477|Drug|DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin)|DWJ1351(FDC Amlodipine/Olmesartan/Rosuvastatin) X 1 tablet followed by Sevikar(Amlodipine/Olmesartan) X 1 tablet and Crestor(Rosuvastatin) X 1 tablet (after washout period)
15886633|NCT03753477|Drug|Sevikar and Crestor|Sevikar(Amlodipine/Olmesartan) X 1 tablet and Crestor(Rosuvastatin) X 1 tablet followed by FDC Amlodipine/Olmesartan/Rosuvastatin X 1 tablet (after washout period)
15886634|NCT03753464|Procedure|Gingival biopsy and blood sample collection|Gingival and blood samples will be collected.
15886635|NCT03753451|Procedure|treatment of periodontal disease|Patients with periodontal disease received treatment of periodontal disease through ultrasound or manual scaling of dental calculations. In addition to receiving instructions to improve oral health, such as the correct use of dental floss, adequate time and the correct way to brush.
15886636|NCT03753438|Procedure|Intragstric Ballooning|Intragstric Ballooning will be put.
15886637|NCT03753425|Procedure|Low volume bowel preparation in inflammatory bowel diseases|Low volume bowel preparation in inflammatory bowel diseases
15886638|NCT03753399|Procedure|acupuncture|Acupuncture at back-shu points according to heat-pain threshold measurement at 24 well-points, combining with electro-acupuncture at fixted acupoints.
15886639|NCT03753386|Other|Oxygen therapy simulation|"The intervention consists of reproducing oxygen therapy situations in healthy individuals by replacing oxygen bottles with bottles of air. A TeleOx® device will be placed on the circuit between the source and the nasal cannula for respiratory signals recording.
~The intervention will last 30 minutes, containing the following activities in the given order:
~rest (9 minutes);
~drinking water (1 minute);
~rest (1 minute);
~coughing (1 minute);
~rest (1 minute);
~reading aloud (1 minute);
~rest (1 minute);
~breathing by the mouth (1 minute);
~rest (1 minute);
~exercising (running) (3 minutes) and
~rest (10 minutes)
~Recordings will be retrieved after each test."
15886640|NCT03753373|Other|Acupuncture|Acupuncture treatments will be utilizing the KB-2 points with manual manipulation accomplished by vigorously running the acupuncturists thumb nail up and down the handle until a perceived sensation change is noted in the subject's posteromedial tibia. A single, sterile 100mm needle will be inserted into the upper third of the medial tibiofibular ligament, followed by a second needle approximately 2-4 cm below the second needle. The needles will be manipulated as detailed above to achieve the sensation change along the posteromedial tibia. The needles will then be irregularly stimulated over the course of 5-7 minutes. The needles will be removed after the treatment is complete, which will last approximately 5-10 minutes (standard care).
15886641|NCT03753373|Other|Home Exercise Program|Subjects will be given a study diary to document the number of times they performed the standard of care prescribed home exercise program. Subjects will be advised to complete the stretching exercises daily and the strengthening exercises every other day.
15886642|NCT03753360|Behavioral|Internet-Based Mindfulness Program - Stress Free Now for Healers|Stress Free Now for Healers is an online stress management program developed at Cleveland. It's delivered in 4 components:1Weekly introductions to the concepts and meditation theme are delivered via Web page views or a 5to10-min audio clip2Weekly guided meditations 5-20 min ea.available as embedded/downloadable mp3 on the website or via the Stress Free Now for Healers phone app,which participants are invited to practice at least 4 times each week and to record those practices3Daily articles provide the scientific underpinnings and merits of each week's theme or discuss various cognitive and behavioral strategies,activities,and concepts supporting or related to mindfulness4Daily tips suggesting how to manage stress or incorporate mindfulness in daily activities,including motivational quotes.Participants will have access to a smartphone app with recordings of the 11 guided meditations.Ea. participant will be assigned an e-coach that will communicate with the participant at least weekly.
15886643|NCT03753360|Behavioral|Active Control Group - Relaxing Music|The control group will be given a flash drive and a link to a website where they can download several digital recordings of relaxing music and will be instructed to quietly listen to one or more of the recordings for at least 5 minutes every day for 6 weeks.
15886644|NCT03753347|Biological|2018-19 quadrivalent inactivated influenza vaccine|A single age-appropriate dose of 2018-19 quadrivalent inactivated influenza vaccine
15886645|NCT03753334|Dietary Supplement|MAG-EPA|5g/day of omega-3-rich fish oil including 4g of purified monoglycerides EPA, capsules, taken once daily, for 12 months
15886646|NCT03753334|Dietary Supplement|Placebo group|5g/day of placebo (high oleic sunflower oil), capsules, taken once daily, for 12 months
15886649|NCT03753321|Dietary Supplement|Placebo (maltodextrin)|Isoenergetic placebo (maltodextrin) for 10 days (7 days pre-loading and 3 days during trials 1 and 2
15886650|NCT03753308|Biological|Blood Sampling|5 x Lithium Heparin Tubes WITHOUT DARK GREEN GEL, 5 ml- v. 4 ml Blood volumes collected as part of the usual care and this research comply with the recommendations of Jarde's law for an observational study (less than 80 ml in one day and less than 160 ml over 30 consecutive days for a subject over 40kg).
15886651|NCT03753308|Biological|Liver biopsy|"The liver biopsy is part of the usual care and it follows the usual procedure of CHUGA:
~The patient is placed in a supine position and received a transitory sedation, MEOPA gas (Kalinox®). Also, an ultrasound scan is performed. Local disinfection followed by local anesthesia with Xylocaine® are performed. The biopsy is performed with the Hepafix 17 gauge needle. 1 passage is carried out to obtain a biopsy fragment of at least 20 mm for the diagnosis (if the passage is unsuccessful, a second passage can be performed strictly as part of the usual care and not as part of research). If the biopsy is> 20 mm, a fragment of the excess biopsy specimen (10% or 2 mm) will be cut and used for research in groups 1b and 2. This division is performed by the clinician directly on the fresh specimen"
15886652|NCT03753295|Diagnostic Test|Hand Grip Force|"For measuring the grip strength, the subjects will be asked to sit on a chair with their hip joint flexed at 90 degree, and shoulder joint in a neutral position.
~The elbow is fixed at 90 degree flexion, forearm in a neutral position, and wrist at 0 to 15 degree radial deviation.
~The test will be performed twice, and the higher value between the two measurements will be selected.
~The subjects will be allowed a rest time of more than 5 minutes after the first measurement to avoid examiner bias and to decrease physical stress"
15886653|NCT03753282|Other|questionnaires for patient reported outcome|"questionnaires with respect to outcomes:
~Reoperations
~Short term complications
~Long term complications
~EQ-5D (current)
~HOOS (current)
~disease related change of occupation
~use of walking aids
~comorbidities
~medication"
15886654|NCT03753282|Other|questionnaire for course of the disease|"questionnaires to assess course of the disease:
~from initial diagnosis of AVN to joint replacement as total hip arthroplasty (THA)
~therapeutic interventions"
15886655|NCT03753269|Drug|Fasudil Hydrochloride|2.5mg fasudil hydrochloride (diulted to 15ml by 0.9% saline )will be delivered by targeted perfusion micro-catheter into culprit vessel right after the first wire passage
15886656|NCT03753269|Drug|Placebo saline|15ml 0.9% saline will be delivered by targeted perfusion micro-catheter into culprit vessel right after the first wire passage
15886657|NCT03753256|Device|Transbond XT|"Application of
~• Transbond XT (activator comparator) to labial surfaces of teeth of randomized quadrants."
15886658|NCT03753256|Device|Protecto®CaF2Nano|"Application of
~• Protecto®CaF2Nano (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants."
15886659|NCT03753256|Device|Pro Seal®|"Application of
~• Protecto®CaF2Nano (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants."
15886660|NCT03753256|Device|Opal®Seal|"Application of
~• Opal®Seal (orthodontic surface sealant) to labial surfaces of teeth of randomized quadrants."
15886661|NCT03753243|Drug|Pembrolizumab|Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
15886662|NCT03753243|Drug|Enzalutamide|Patients will receive daily oral doses of study drug (enzalutamide 160 mg/day), which will be administered as four capsules/day to be taken at or near the same time each day.
15886663|NCT03753230|Device|Electroencephalography|Cerebral measurements from electroencephalography devices while music is presented to the participant
15886664|NCT03753217|Device|qCON Monitor|supervision by qCON monitor of the depth of anesthesia
15886666|NCT03753191|Device|transcranial direct current stimulation|Each subject will undergo one tDCS stimulation session lasting for 20 minutes. A constant current of 2 mA will be applied with a linear fade in, fade out of 10 seconds to prevent electrical transients.
15886667|NCT03753165|Other|High intensity interval exercise|High intensity interval exercise at 80% of the maximal heart rate derived from the maximal graded exercise. Each individual will undergo 12 sessions of HIIE over a period of six weeks
15886668|NCT03753152|Device|experimental|Neuramis® Deep Lidocaine
15886669|NCT03753152|Device|comparator|YVOIRE® Volume Plus
15886670|NCT03753139|Device|Heart rhythm monitoring with portable device|"The study compares the ability of lightweight measurement methods to detect different heart rhythms compared to the Holter registration.
~Faros 360 ECG sensor with wet electrodes. Faros 360 Holter is CE and FDA 510 cleared class 2a medical device, which is attached to the patient's chest with five single-use wet electrodes.
~Suunto Movesense one-time ECG device (Suunto Oy, http://www.suunto.com Vantaa Finland). Movesense is CE cleared consumer device, which is used with two dry electrodes to the ECG measurement.
~Empatica E4 activity bracelet (Empatica Ltd http://www.empatica.com Milan, Italy), which is CE cleared consumer device. Empatica E4 is a photopletysmogram which measures optically the amount of blood circulating in the blood vessel.
~Samsung Gear S3 wearable (Samsung Electronics, Co., Soul, South Korea) which is CE cleared consumer device. Gear S3 is a photopletysmogram, which measures optically the amount of blood circulating in the blood vessel."
15886671|NCT03753126|Radiation|4-dimensional volume-rendered computed tomography|
15886672|NCT03753113|Drug|Topical Herbal Solution|Use Topical Herbal Solution every day in scalp hair loss areas for 36 weeks.
15886673|NCT03753113|Drug|Topical Minoxidil 5%|Use Minoxidil 5% solution every day in scalp hair loss areas for 36 weeks.
15886703|NCT03752840|Other|Optical coherence tomography (OCT)|OCT will be used to image the anterior segment, the macula, and the retinal nerve fiber layer. The images will be assessed for abnormalities and participants meeting referral criteria will be referred to the local eye hospital.
15886704|NCT03752840|Other|Intraocular pressure|Intraocular pressure will be measured using an iCare tonometer. Participants meeting referral criteria will be referred to the nearest eye care center or eye hospital.
15886836|NCT03752125|Dietary Supplement|Flavonoid, caffeine|2 flavonoid/caffeine capsules before breakfast, 2 capsules before lunch
15886674|NCT03753100|Other|Dual-energy X-ray absorbtiometry to evaluate periprosthetic bone mineral density around an uncemented stem implanted using either lateral or anterolateral approach to the hip joint|The measurement will start in the area about 2 cm proximal to the greater trochanter and will stop slightly below the tip of the prosthesis. This is the baseline scan and will be carried out twice with the patient lying on the table, but with movement between each scan. This is done to calculate the CV, Coefficient of Variation. We will use the formula from Wilkinson and associates, where delta is standard deviations (SD) of the difference between the two BMD measurements for each patient. BMD has been measured at baseline, 3 and 12 months. A DXA scan is now planned at 60 months. Changes in BMD related to the 7 Gruen zones will be registered.
15886675|NCT03753087|Drug|Empagliflozin|10 mg tablet
15886676|NCT03753087|Other|Standard care|Standard care with no SGLT-2 inhibitors
15886677|NCT03753074|Drug|Tenofovir Alafenamide|Tenofovir Alafenamide 25mg, Tablet, Oral, Daily
15886678|NCT03753061|Device|Aspiration Catheter|Patients will be treated for mechanical recanalization with Aspiration Catheter within 8 hours after stroke onset plus standard medical management.
15886679|NCT03753061|Device|Solitaire FR|Patients will be treated for mechanical recanalization with Solitaire FR within 8 hours after stroke onset plus standard medical management.
15886680|NCT03753048|Procedure|Y-Graft|Y-Graft Configuration Using BITA. Surgery can be performed off-pump or on the CPB. Both internal thoracic arteries should be harvested in semi-sceletonized fashion. After the administration of 3 mg/kg i/v UFH, the left internal thoracic artery is cut off distally and the right internal thoracic artery is cut off proximally and distally. Then they anastomose the following way. Left internal thoracic artery should be anastomosed to the left anterior descending artery (LAD) at first. Secondly, distal part of the right internal thoracic artery should be anastomosed to the obtuse marginal artery. Finally, proximal part of the right internal thoracic artery is anastomosed to the left internal thoracic artery as Y-graft in the end to side fashion. If it is nessesary, the right coronary artery system can be bypassed by separate autoarterial (eg. radial artery) or autovenous graft with proximal anastomose to the aorta.
15886681|NCT03753048|Procedure|In-Situ|In-Situ Configuration Using BITA. Surgery can be performed off-pump or on the CPB. Both internal thoracic arteries should be harvested in semi-sceletonized fashion. After the administration of 3 mg/kg i/v UFH, both internal thoracic arteries are cut off distally. Then they anastomose the following way. Right internal thoracic artery should be anastomosed to the left anterior descending artery (LAD) at first. Secondly, left internal thoracic artery should be anastomosed to the obtuse marginal artery. If it is nessesary, the right coronary artery system can be bypassed by separate autoarterial (eg. radial artery) or autovenous graft with proximal anastomose to the aorta.
15886682|NCT03753022|Other|Group G5|Submitted to peep 5
15886683|NCT03753022|Other|Group G10|Submitted to peep 10
15886684|NCT03753022|Other|Group G15|Submitted to peep 15
15886685|NCT03753009|Procedure|corneal cross-linking|"Epithelium-off CXL was performed according to the Siena (Dresden modified) protocol: 2% pilocarpine was instilled 30 minutes before treatment, the epithelium was removed using a blunt knife. An isotonic solution of riboflavin 0.1% and dextran 20% was instilled for 10 minutes of corneal soaking before starting UV-A irradiation. The solution was administered every 3 minutes for a total of 30 minutes of UV-A exposure at 3mW/cm2.
~The iontophoresis device was filled with a hypoosmolar riboflavin 0.1% dextran-free solution enriched with ethylenediaminetetraacetic acid and trometamol. The device was then connected to a constant current generator initially set at 0.5 mA and increased to 1.0 mA to find out the individual tolerance. Iontophoresis was then performed for 5 minutes. The corneal device was then removed before performing UVA irradiation. During the irradiation phase (10 mW/cm2 for 9 minutes), good fluorescence was clearly detectable. The total treatment time was 14 minutes."
15886686|NCT03752996|Device|ACURATE TF™ Aortic Valve System|Transcatheter Aortic Valve Implantation
15886687|NCT03752983|Diagnostic Test|blood samples|blood samples
15886690|NCT03752944|Procedure|lefort I osteotomy for maxillary advancement|fixation of lefort I osteotomy in patients with retruded maxilla with two prebent plates versus four miniplates.
15886691|NCT03752931|Drug|Celiprolol|receiving 1 tablet per day of Celiprolol 200 mg in the morning from the first postoperative day after pneumonectomy or bi lobecomty for 2 weeks.
15886692|NCT03752931|Drug|Diltiazem|receiving 1 tablet per day of Diltiazem 200 mg in the morning from the first postoperative day after pneumonectomy or bi lobecomty for 2 weeks.
15886693|NCT03752918|Drug|MDMA|A single dose of 1.5mg/kg will be administered once orally.
15886694|NCT03752918|Drug|Niacin|A single dose of 250mg will be administered once orally.
15886695|NCT03752905|Drug|PTR-01|Recombinant human collagen 7 (rC7)
15886696|NCT03752905|Drug|Normal saline|Saline control
15886697|NCT03752892|Other|intervention -1-leg cycle training|partitioned aerobic exercise training
15886698|NCT03752892|Other|usual care - 2-leg cycle training|conventional aerobic exercise training
15886699|NCT03752879|Procedure|Fundal Pressure|Fundal Pressure to assist the vaginal delivery to shorten the second stage of labor
15886700|NCT03752866|Device|Portico™ Valve, Delivery System(s) and Loading Systems(s)|Subjects will undergo implantation of a commercially available Portico transcatheter aortic heart valve
15886701|NCT03752853|Behavioral|internet-based intervention for mild to moderate depression|The six-weeks, therapist-guided, internet-based intervention for depression includes expressive writing tasks and further consists of key elements of cognitive behavioral therapy (CBT) for depression. In seven consecutive modules, patients receive psychoeducation and instructions for weekly tasks, and an individualized feedback letter of their therapist after each module. The intervention is effective in reducing depressive symptoms (Zagorscak et al., 2018). In the current study, patients will be randomly assigned to two different conditions with varying orders of modules: 1. patients will receive two modules (module 3 and 4) of behavioral activation, followed by two modules (modules 5 and 6) of cognitive restructuring; 2. patients will receive two modules (module 3 and 4) of cognitive restructuring, followed by two modules (modules 5 and 6) of behavioral activation. All other modules (1, 2 and 7) will be identical across conditions.
15886702|NCT03752840|Other|Visual acuity (presenting and pinhole)|Presenting and pinhole visual acuity will be assessed using the Peek Acuity mobile application. Participants meeting referral criteria will be referred to the nearest eye care center or eye hospital.
15886705|NCT03752840|Other|Active linkage to care|Referred participants will be followed closely by study staff to ensure completion of follow-up visits.
15886706|NCT03752827|Device|Adipose Derived Regenerative Cells|Adipose-derived regenerative cells isolated with the Transpose Ultra system
15886707|NCT03752827|Drug|Corticosteroid|Corticosteroid injection into subacrominal space
15886708|NCT03752814|Device|SYNOSTE Nitinail System|Mode of application: 1. Implantation surgery: osteotomy and antegrade implantation of SNS in femur for distraction osteogenesis (callotasis), 2. distraction osteogenesis (implant lengthening phase), 3. Bone healing (implant as stabilizing element during consolidation phase), 4. Explantation after consolidation.
15886709|NCT03752788|Behavioral|Dual-task Training Fixed Priority|"Dual-task training fixed priority instructional set for four weeks. Balance training sessions of 45 minutes per day, 3 times a week for four weeks, so as to complete 9-12 hours of training warm-up improve the balance performance. This included 12 repetitions in each session for 30 minutes after a 10-minutes warm up.
~Attention was focused on both postural and cognitive tasks throughout this session. In postural tasks, subjects were instructed to perform the following: walk narrow base of support with a cognitive task of counting backward by three walk narrow base of support with cognitive task of count forward by three, walk narrow base of support, step, sideways, backward avoiding the obstacles (holding a basket) with cognitive task to remember words."
15886710|NCT03752788|Behavioral|Dual-task Training Variable Priority|"Dual-task training variable priority instructional set for four weeks. Balance training sessions of 45 minutes per day, 3 times a week for four weeks, so as to complete 9-12 hours of training warm-up improve the balance performance. This included 12 repetitions in each session for 30 minutes after a 10-minutes warm up.
~During the first half of the training session, attention was focused on postural tasks, while during the remaining half of the session, attention was focused on cognitive tasks."
15886711|NCT03752775|Device|Robot assisted upper limb rehabilitation|The patients in the experimental and the other arms will receive 20 session device assisted upper limb rehabilitation. In each session, a subject will conduct multi-joint coordinated upper limb motions for 1 hour.
15886712|NCT03752762|Dietary Supplement|SQ-LNS|SQ-LNS is a peanut-based ready to use home fortification product to improve diet quality in children 6-24 months of age. It includes peanuts and other ingredients such as vegetable fat, powdered milk and several micronutrients. The formulation designed for this study will not include sugar.
15886713|NCT03752762|Behavioral|SPOON behavioral change strategy|An innovative behavioral change strategy designed using ethnographic and marketing methods to promote adequate infant and young child feeding practices and the use of SQ-LNS. The strategy will be delivered to mothers or caregivers through individual home-visits and group sessions.
15886714|NCT03752749|Other|Prednisolone + Acute Intermittent Hypoxia|Administration of oral prednisolone followed by 15, 60-second bouts of mild hypoxia
15886715|NCT03752749|Other|Placebo + Acute Intermittent Hypoxia|Administration of oral matching placebo followed by 15, 60-second bouts of mild hypoxia
15886716|NCT03752736|Behavioral|"I wear sunscreen everyday song-based video"|"All four classes (arms) will be shown (sitting on carpet, not participating) a 2-3 minute song-based video titled I wear sunscreen everyday in which they observe elementary age children applying sunscreen in a systematic fashion. Following the viewing, classes will be administered this video guided, song- based intervention while their teacher documents their independent participation using our classroom map data collection sheet."
15886717|NCT03752723|Drug|GX-I7|i.m.
15886718|NCT03752723|Drug|Pembrolizumab|i.v.
15886719|NCT03752723|Drug|cyclophosphamide|i.v.
15886720|NCT03752697|Behavioral|metacognitive performance|Paper and pencil/computerized tests of metacognition
15886721|NCT03752684|Other|Low Oxalate Diet|Subjects will be instructed to ingest a controlled diet low in oxalate
15886722|NCT03752684|Other|Moderately high oxalate/low calcium diet|Subjects will be instructed to ingest a controlled diet moderately high in oxalate
15886723|NCT03752684|Other|Oxalobacter formigenes|Subjects will ingest liver preparation of O. formigenes
15886724|NCT03752671|Device|Insertion of INTRASPINE device|"The surgical technique for excision of the disc hernia is the surgeon's usual technique: patient positioning (lying on his/her back or front or in the knee to chest position) the approach to the lumbar disc hernia (interlaminar or interspinous), closure and drainage of the operation site are performed by the surgeon's usual practice.
~IntraSPINE® is positioned once surgery for the disc hernia has been performed. The implant bed is prepared with the assistance of the distractor provided. The choice of implant size is made after positioning the trial device corresponding to the anatomical bed. Once the size has been established the corresponding implant is placed in a cup of physiological saline prior to implantation. Implantation is performed using the appropriate implant holder."
15886725|NCT03752671|Procedure|Discectomy|The surgical technique for excision of the disc hernia is the surgeon's usual technique: patient positioning (lying prone or supine or in the knee to chest position). The approach to the lumbar disc hernia (interlaminar or interspinous), closure and drainage of the operation site are performed using the surgeon's normal practice.
15886726|NCT03752658|Drug|Tenofovir Alafenamide|The dose of tenofovir alafenamide (TAF) will be 25mg tablet taken orally once daily with food for 36 months, patients will be treated with TAF alone or in combination with anti-HBV agents
15886727|NCT03752645|Device|Transverse Many Channels Laser Instrument|The device consists of a control box and 4 sets of two light-emitting nasal probes. Prior to treatment, each patient put on a pair of black tinted glasses, and had the nasal probes gently placed into both nostrils. A turn-on switch on the control box activated the probe and the timer was set at 15 minutes during which time 36 J of light energy was delivered to each nostril.
15886728|NCT03752632|Device|Veinplicity with tourniquet|Veinplicity will be used with a tourniquet
15886729|NCT03752632|Device|Tourniquet|A tourniquet alone will be used.
15886760|NCT03752372|Procedure|hematopoietic stem cell transplantation|"Reduced intensity conditioning(RIC) chemotherapy regimen before transplantation
~All patients were cared for in single rooms ventilated with a highly effective particulate air filtration system. All patients received intravenous immunoglobulin and antimicrobial prophylaxis, which included antiviral, antifungal, and Pneumocystis jirovecii prophylaxis with ganciclovir and micafungin, as per routine clinical practice before transplantation.
~Umbilical cord blood transplantation"
15886837|NCT03752125|Dietary Supplement|Placebo|2 placebo capsules before breakfast, 2 capsules before lunch
15897710|NCT03667937|Other|AQUACEL silver|Silver Dressing
15886730|NCT03752619|Device|Contracting Producing Peripheral Nerve Stimulation|The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad has an embedded power source but also serves as the anode. The 1-channel stimulator outputs a biphasic current waveform with current pulse parameter ranges suitable for Peripheral Nerve Stimulation (PNS). The percutaneous lead is inserted using an introducer (like a hypodermic needle) which is withdrawn and the lead is retained in the muscle by a barb at its tip. After a 1-week stabilization period, stimulation is initiated (6 hrs/day). The duty cycle and daily dose remain constant, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period is 3 weeks after which the lead will be removed.
15886731|NCT03752619|Device|Non Contracting Producing Peripheral Nerve Stimulation|The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad has an embedded power source but also serves as the anode. The 1-channel stimulator outputs a biphasic current waveform with current pulse parameter ranges suitable for Peripheral Nerve Stimulation (PNS). The percutaneous lead is inserted using an introducer (like a hypodermic needle) which is withdrawn and the lead is retained in the muscle by a barb at its tip. After a 1-week stabilization period, stimulation is initiated (6 hrs/day). The duty cycle and daily dose remain constant, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period is 3 weeks after which the lead will be removed.
15886732|NCT03752619|Other|Physical Therapy|All participants receive eight 1.0 hr. sessions of physical therapy (PT) over a 4-wk period from a therapist blinded to Peripheral Nerve Stimulation (PNS) treatment assignment. Each participant also performs home exercises. The primary objective of physical therapy (PT) and the home exercise program is to prevent re-injury by educating and training participants in the biomechanics and proper use of the shoulder and upper limb. During each in-lab session, participants are trained in the implementation of these exercises, which are individually adjusted and progressed with increasing external loads by using weights and elastic rubber bands.
15886733|NCT03752606|Biological|TACHOSIL GROUP|
15886734|NCT03752593|Other|ET Tube|Patients with a BMI of greater than 30 or less than who are presenting to the hospital for any surgical procedure requiring general anesthesia
15886735|NCT03752580|Device|User Instructions of novel nasal mask|User Unstructions interpretation of novel nasal mask for the treatment of obstructive sleep apnea (OSA).
15886736|NCT03752567|Other|Follow up|like group descriptions
15886737|NCT03752554|Procedure|segmental resection|All cases will undergo surgery under general anesthesia. The mandibular lesion will be segmentally resected. The cuts will be performed with the aid of the prefabricated digital template. The neurovascular bundle will be separated and protected. Then reconstruction will be performed
15886738|NCT03752541|Biological|BCMA-UCART|A conditioning therapy with cyclophosphamide and fludarabine will be conducted for subjects before CART therapy.
15886739|NCT03752528|Diagnostic Test|Blood sample collection|Determination of buprenorphine and norbuprenorphine plasma concentrations
15886740|NCT03752528|Diagnostic Test|Urine sample collection|Urine sample for determination of free buprenorphine and free norbuprenorphine concentrations, qualitative UDS for opioids, quantitative UDS for buprenorphine, norbuprenorphine and naloxone, and determination of creatinine concentration
15886741|NCT03752502|Procedure|Transcranial direct current stimulation (tDCS)|Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation (NIBS) technique that has been investigated for the management of various chronic pain conditions. However, as a monotherapy for pain relief, this therapy still has controversial results.
15886742|NCT03752502|Procedure|Peripheral electrical stimulation (PES)|Peripheral electrical stimulation (PES) activates a complex neural network involving a series of neurotransmitters and receptors capable of promoting segmental and extrasegmental analgesia.
15886743|NCT03752502|Procedure|Sham tDCS|Transcranial direct current stimulation (tDCS) is a noninvasive brain stimulation (NIBS) technique that has been investigated for the management of various chronic pain conditions. However, as a monotherapy for pain relief, this therapy still has controversial results.
15886744|NCT03752489|Diagnostic Test|Treatment-specific InSight|The InSight algorithm which draws information from a patient's electronic health record (EHR) to predict the onset of severe sepsis, and in this study will be customized to differentiate between clusters of patients who respond similarly to fluids treatment according to the nature of their disease progression.
15886745|NCT03752489|Diagnostic Test|InSight|The non-customized InSight algorithm which draws information from a patient's electronic health record (EHR) to predict the onset of severe sepsis.
15886746|NCT03752476|Procedure|number of Beta lactam class prescription for the same infection|Each number of Beta lactam prescription without interruption are compared
15886747|NCT03752463|Drug|DAOI-A group|DAOI with A dose
15886748|NCT03752463|Drug|DAOI-B group|DAOI with B dose
15886749|NCT03752463|Drug|DAOI-C group|DAOI with C dose
15886750|NCT03752463|Drug|Placebo oral capsule|Placebo
15886751|NCT03752437|Diagnostic Test|ACT (Activated Clotting Time)|Measure of ACT in the two arms in order to determine if injection of heparin based on ideal weight is better or not than those one on real weight.
15886752|NCT03752437|Drug|Heparin|300 IU of heparin
15886753|NCT03752424|Drug|Silver nanoparticles|The active group will receive silver nanoparticles in different dosage forms as an anti-microbial drug.
15886754|NCT03752424|Drug|Topical approved anti-microbial gel|The placebo group will receive topical FDA approved anti-microbial jel in different dosage forms as control drug.
15886755|NCT03752411|Other|Research Bottle|The purpose of the study is to test a research prescription bottle that will monitor the physical environment inside the bottle.
15886756|NCT03752411|Other|Regular prescription Bottle|This will test if the research bottle changes behavior relative to the research bottle
15886757|NCT03752398|Biological|XmAb®23104|Monoclonal bispecific antibody
15886758|NCT03752398|Biological|Yervoy® (ipilimumab)|Monoclonal antibody
15886759|NCT03752385|Behavioral|reducing smartphone screen time|"Cutting average smartphone screen time in half. Sleeping without smartphone in bedroom. Establishing a bedtime to stop smartphone screen time."
15886783|NCT03752229|Device|Prolance Low Flow|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886761|NCT03752359|Dietary Supplement|whey protein|This two-arm randomized, double-blind, placebo-controlled design was carried out over a period of 16 weeks. At the beginning and end of the experiment, two weeks were allocated for evaluations consisting of anthropometric (weeks 2 and 16), body composition (weeks 2 and 16), one repetition maximum tests (weeks 1 and 15), functional capacity tests (weeks 1 and 15), blood samples (weeks 2 and 16) and dietary intake measurements (weeks 1 and 15). The anthropometric, body composition, blood samples and dietary intake measurements were carried out in a temperature-controlled room (22-24 °C), and the RT sessions were conducted at the university training facility.
15886762|NCT03752359|Dietary Supplement|placebo|This two-arm randomized, double-blind, placebo-controlled design was carried out over a period of 16 weeks. At the beginning and end of the experiment, two weeks were allocated for evaluations consisting of anthropometric (weeks 2 and 16), body composition (weeks 2 and 16), one repetition maximum tests (weeks 1 and 15), functional capacity tests (weeks 1 and 15), blood samples (weeks 2 and 16) and dietary intake measurements (weeks 1 and 15). The anthropometric, body composition, blood samples and dietary intake measurements were carried out in a temperature-controlled room (22-24 °C), and the RT sessions were conducted at the university training facility.
15886763|NCT03752346|Other|exercise group|"A step aerobics exercise lasted a total 30 minutes, including:
~a warm-up with 10 minutes of stretching exercises.
~A step aerobics exercise (step aerobics for 30 minutes; step by step, step exercise, or stepping the ground repetitively)23,24 a total of 30 minutes then cool down (5 minutes).
~Resistance training (10 minutes), stretching and relaxation for 10-15 minutes."
15886764|NCT03752333|Drug|Pembrolizumab|"Pembrolizumab has high affinity and potent receptor blocking activity for PD-1, based on preclinical in vitro data. Pembrolizumab has an acceptable preclinical and clinical safety profile and is in clinical development as an IV immunotherapy for advanced malignancies.
~The PD-1 pathway represents a major immune control switch, which may be engaged by tumour cells to overcome active T-cell immune surveillance. Pembrolizumab is a potent and highly selective humanized mAb of the Immunoglobulin (IgG4)/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. This blockade enhances functional activity of the target lymphocytes to facilitate tumor regression and ultimately immune rejection."
15886765|NCT03752307|Drug|Isoxsuprine Hydrochloride|Compounded Isoxsuprine hydrochloride capsules
15886766|NCT03752307|Drug|Placebo|Identical microcrystalline cellulose placebo manufactured to mimic Isoxsuprine Hydrochloride 10 MG capsules
15886767|NCT03752307|Drug|Corticosteroid|This can be any accepted regimen, including daily iv methylprednisolone 1000 mg/day or 600mg oral prednisone two times a day at approximately 8AM and noon
15886768|NCT03752294|Drug|Dabigatran|At the end of a 9-month randomized-control, double-blind treatment all study participants will cross-over to the 12-month open-label phase with a 3-month non-treatment follow-up.
15886769|NCT03752294|Drug|Placebo - Cap|At the end of a 9-month randomized-control, double-blind treatment all study participants will cross-over to the 12-month open-label phase with a 3-month non-treatment follow-up
15886770|NCT03752281|Other|Investigation of health and activity|During a six months multidisciplinary investigation of health status, activity and working ability for individuals receiving long-term social assistance, the health and activity status as well as function will be described using established questionnaires and the International Classification of Functioning
15886771|NCT03752268|Behavioral|Enhancing Cancer Pain Management|Patients will learn and practice an enduring framework of cognitive-behavioral strategies, to enhance adherence behavior, reduce intentional and unintentional deviations from the prescribed regimen.
15886772|NCT03752255|Other|Anxiety measurement method|Two different techniques (video or verbal information) will be examined about impacted third molar surgery.
15886773|NCT03752242|Drug|BMX-010|Safety and efficacy of BMX-010 in topical treatment of acne.
15886774|NCT03752229|Device|Acti-Lance Lite|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886775|NCT03752229|Device|Acti-Lance Universal|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886776|NCT03752229|Device|Acti-Lance Special|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886777|NCT03752229|Device|Medlance Plus Super Lite|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886778|NCT03752229|Device|Medlance Plus Lite|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886779|NCT03752229|Device|Medlance Plus Universal|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886780|NCT03752229|Device|Medlance Plus Extra|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886781|NCT03752229|Device|Medlance Plus Special|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886782|NCT03752229|Device|Prolance Micro Flow|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15898279|NCT03662984|Drug|Placebo Oral Tablet|To compare ciprofibrate
15886784|NCT03752229|Device|Prolance Normal Flow|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886785|NCT03752229|Device|Prolance High Flow|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886786|NCT03752229|Device|Prolance Max Flow|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886787|NCT03752229|Device|Prolance Pediatric|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886788|NCT03752229|Device|Haemolance Micro Flow|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886789|NCT03752229|Device|Haemolance Low Flow|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886790|NCT03752229|Device|Haemolnace Normal Flow|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886791|NCT03752229|Device|Haemolance High Flow|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886792|NCT03752229|Device|Haemolance Max Flow|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886793|NCT03752229|Device|Haemolance Pediatric|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886794|NCT03752229|Device|MediSafe Solo 29 Gauge|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886795|NCT03752229|Device|MediSafe Solo 23 Gauge|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886796|NCT03752229|Device|ergoLance Micro Flow|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886797|NCT03752229|Device|ergoLance Normal Flow|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886798|NCT03752229|Device|ergoLance High Flow|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886799|NCT03752229|Device|Medlance (light blue)|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886800|NCT03752229|Device|Medlance (blue)|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886801|NCT03752229|Device|Medlance (dark blue)|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886802|NCT03752229|Device|Medlance (yellow)|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886803|NCT03752229|Device|Medlance (orange)|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886804|NCT03752229|Device|Medlance (red)|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886805|NCT03752229|Device|Unistik 3 Extra|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886833|NCT03752138|Drug|Expansion Phase TK216|Expansion cohort will receive the RP2D of TK216
15886806|NCT03752229|Device|Unistik 3 Comfort|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886807|NCT03752229|Device|Unistik Touch|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886808|NCT03752229|Device|ReadyLance (blue)|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886809|NCT03752229|Device|ReadyLance (orange)|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886810|NCT03752229|Device|AssureLance|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886811|NCT03752229|Device|AssureLance MicroFlow|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886812|NCT03752229|Device|Surgilance|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886813|NCT03752229|Device|Surgilance Lite (grey)|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886814|NCT03752229|Device|Surgilance Lite (purple)|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886815|NCT03752229|Device|SteriLance Lite2|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886816|NCT03752229|Device|SensiLance (pink)|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886817|NCT03752229|Device|SteriLance Press|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886818|NCT03752229|Device|SensiLance (orange)|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886819|NCT03752229|Device|mylife|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886820|NCT03752229|Device|VeriFine|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886821|NCT03752229|Device|Microdot|"Finger lancing was undertaken in a standardized way and was performed by medical staff trained from lancing procedure described in the Protocol.
~Total blood collection time was recorded in the source documentation and then volume of the blood was measured using a calibrated ruler."
15886822|NCT03752216|Drug|Niraparib|"Two different doses of Niraparib can be administrated:
~For patient who had at baseline (T0) a body weight ≥ 77 kg and a platelet count ≥ 150 000/µL, Niraparib will be administrated at a dose of 300 mg daily. The planned dose of 300 mg daily will be made up of three 100 mg capsules.
~For patient who had at baseline (T0) a body weight < 77 kg or a platelet count <150 000/µL, Niraparib will be administrated at a dose of 200 mg daily. The planned dose of 200 mg daily will be made up of two 100 mg capsules.
~Patient should continue to receive study treatment until disease progression as per RECIST as assessed by the investigator or they do not meet any other discontinuation criteria."
15886823|NCT03752203|Drug|Sodium Fluorescein|Patients enrolled in this study will receive 3 mg/kg sodium fluorescein following induction of anesthesia by administration into a peripheral venous line over 10 seconds
15886824|NCT03752203|Device|Microscopic Resection|Resection will proceed with the use of a surgical microscope equipped with excitation and barrier filters for monitoring with sufficient fluorescent enhancement and contrast.
15886825|NCT03752190|Drug|Cosyntropin|intramuscular and intravenous administration
15886827|NCT03752164|Behavioral|Yoga and Mindfulness Skills|Single brief session in which children are taught yoga and skills in mindfulness
15886828|NCT03752151|Device|MARVEL 2 Algorithm Monitor Mode then Adaptive Mode|Software download into implanted Micra device and programmed to MARVEL 2 Monitor Mode then MARVEL 2 Adaptive Mode
15886829|NCT03752138|Drug|Group 1: TK216|Starting Dose: 288 mg/m2 given by vein on Days 1-7 of a 21 day cycle.
15886830|NCT03752138|Drug|Group 2: TK216|Starting Dose: 144 mg/m2 given by vein on Days 1-7 and 15-21 of a 23 day cycle.
15886831|NCT03752138|Drug|Part 2: Decitabine 10mg/m2|10mg/m2 by vein on Days 1-10 of a 28 day cycle.
15886832|NCT03752138|Drug|Part 2: Decitabine 20 mg/m2|20 mg/m2 by vein on Days 1-10 of a 28 dayi cycle.
15886838|NCT03752112|Drug|Cefixime|Cefixime 400mg taken orally two times a day for 10 consecutive days in non-pregnant women with early syphilis infection
15886839|NCT03752112|Drug|Benzathine penicillin 2.4 million units|Benzathine penicillin 2.4 million units: The investigators will include a contemporary arm of participants that will receive standard of care treatment with Benzathine penicillin 2.4 million units according to the Brazil national STI treatment guidelines. The investigators will use a ratio of 2 patients receiving cefixime to 1 patient receiving benzathine penicillin.This non-comparator arm of benzathine penicillin will be included to account for study population differences in terms of stage of disease, history of prior infection, experience of re-infection, experience of serofast state, or other co-factors that could impact serological response
15886840|NCT03752099|Drug|VERU-111|VERU-111
15886841|NCT03752086|Procedure|greater omentum binding|Bind pancreatic stump using greater omentum after distal pancreatectomy
15886842|NCT03752086|Procedure|Pancreatic stump exposed without omentum binding|Pancreatic stump exposed without greater omentum binding after distal pancreatectomy
15886843|NCT03752073|Device|Trans-cervical cervical balloon|Insertion of Foley Catheter
15886844|NCT03752073|Device|Hygroscopic cervical dilator|Insertion of Dilapan-s
15886845|NCT03752060|Behavioral|Resistance Exercise|Women assigned to the resistance exercise training group will complete progressive, full-body resistance exercise 3 times per week for 16 weeks.
15886846|NCT03752060|Behavioral|Aerobic Exercise|Women assigned to the aerobic exercise training group will complete progressive, aerobic exercise 5 times per week for 16 weeks. The aerobic training will progress first in duration, and then in intensity.
15886847|NCT03752034|Other|Muscle Fiber Fragments (MFFs)|During the rotator cuff repair procedure, a biopsy of muscle will be taken from the pectoralis major and processed under sterile conditions in the operating room to obtain MFFs. The final product, composed of autologous MFFs in suspension, will be delivered via targeted injection into the muscle belly of the supraspinatus through the Naviaser Portal with visual guidance after rotator cuff repair is complete.
15886848|NCT03752021|Procedure|Myometrial Sampling|"A myometrial sample will be obtained at the time of cesarean delivery. Sample will be obtained from the superior edge of the existing lower uterine segment incision and will be 2 inches in length and 0.5 inches in width. The uterine incision will be repaired in a standard two-layer closure. If a classical cesarean (vertical) uterine incision is deemed necessary and is performed by the surgical team, a sample of the same size will be taken parallel to the incision at the existing edge. The classical uterine incision will be closed utilizing the standard layered technique.
~Placenta and gestational membrane tissue will be obtained after placental delivery. The entire placenta and attached gestational membranes will be collected if not being sent for pathologic review"
15886849|NCT03752008|Behavioral|Active Play (AP)|This intervention focused on promoting PA in preschoolers through structured, teacher-led activities that could be incorporated into daily curriculum. Teachers attended a 3-hour workshop that included presentation and discussion of 1) the importance of daily physical activity for children's health and development, 2) teachers' beliefs and barriers to promoting PA, and 3) the Active Play! Intervention materials. Teachers were introduced to and given the Active Play! Fun Physical Activities for Young Children Book and Digital Video Disk (DVD), which promotes PA and fundamental movement skills in young children. Clips of the DVD demonstrating various activities were shown and activities were modeled. Examples of activities include jumping on bubble wrap, hula hoop limbo and an indoor obstacle course. The end of the book has a suggested curriculum that teachers could follow. Centers in the Active Play! intervention also received a set of portable toys needed for the suggested activities.
15886850|NCT03752008|Behavioral|Outdoor Play (OP)|This intervention focused on promoting outdoor time in preschoolers as a means to increasing their PA, using both child initiated and teacher-led activities. The training and materials were designed to emphasize the teacher's own connection with nature, the benefits of outdoor time for children and adults, and problem solving around barriers encountered. Teachers at participating centers attended one 3-hour workshop (delivered at the childcare center) that focused on having participants recognize their own connection with the natural world and how to transmit that to the next generation. Teachers were given hats and gloves for themselves, a set of rain jackets and boots for the preschoolers, and ideas on what children could do outdoors to be active.
15886851|NCT03751995|Behavioral|Mindfulness meditation|"Participants in the intervention group will have their choice of two commercially available mindfulness programs, HeadspaceTM and eMindful for 6 weeks.
~The Headspace program provides progressive guided mindfulness meditation instruction via a website and mobile app to help users learn the skills of mindfulness for use in everyday life. Sessions last 3-20 minutes. Videos encourage the integration of mindfulness into daily life.
~eMindful offers an online virtual classroom where participants can participate in synchronous, 1-hour mindfulness classes 1-2 times per week. The program is modeled after the mindfulness-based stress reduction (MBSR) program. eMindful also offers a cancer-specific meditation course that participants may choose to participate in."
15886852|NCT03751982|Device|Transcranial Electrical Neuromodulation (TES)|TES phase-aligned with slow waves or not
15886853|NCT03751969|Drug|HSK3486|The first 2 subjects will receive an intravenous injection of 0.4 mg/kg of HSK3486 emulsion injection (containing [14C] HSK3486 at a radiation dose of 5 nCi/0.4 mg/kg, i.e. a subject with the body weight of 60 kg is administered with a radiation dose of 300 nCi). The radiation dose for subsequent subjects can be adjusted based on the results of the first 2 subjects.
15886854|NCT03751956|Drug|HSK3486|The subjects will receive an intravenous injection of 0.8 μCi/0.4 mg/kg of [14C]HSK3486 emulsion injection (i.e., a subject with the body weight of 60 kg is administered with a radiation dose of 48 μCi).
15886855|NCT03751943|Device|NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)|NanoFUSE® Bioactive Matrix (75%) w/autograft (25%)within one posterolateral gutter
15886856|NCT03751930|Other|Samples|Urinary and faecal samples
15886857|NCT03751917|Drug|Arsenic Trioxide|This is an observational study. Patients who have received or are receiving all trans retinoic acid (ATRA) + Arsenic Trioxide will be followed and analyzed.
15886858|NCT03751904|Device|AcoustiCare|Electronic stethoscope
15886859|NCT03751891|Device|Phonak Audéo B90-Direct|The Phonak Audéo B90-Direct is the most recent Receiver-in-the-canal Hearing aid from Phonak which will be fitted to the participants individual Hearing loss.
15886860|NCT03751891|Device|HearingAid_A|HearingAid_A is the most recent Receiver-in-the-canal Hearing aid from manufacturer_A which will be fitted to the participants individual Hearing loss.
15886861|NCT03751891|Device|HearingAid_B|HearingAid_B is the most recent Receiver-in-the-canal Hearing aid from manufacturer_B which will be fitted to the participants individual Hearing loss.
15886862|NCT03751878|Behavioral|Evaluation of reporting inconsistencies|"The completed CONSORT checklist submitted by authors of manuscripts randomised to the intervention group will be assessed by the lead investigator (DB) as to whether it is consistent with the information that was actually reported in the manuscript. This evaluation will be focused on 8 core CONSORT items.
~DB will produce a standardised report containing precise requests for authors in order to improve the completeness of reporting of the items where reporting inconsistencies were found. This report will consist of a brief introduction followed by a point by point description of the inconsistencies found together with precise requests related to the information missing and examples extracted from CONSORT. DB will upload this report to the submission on the managing system of the journal (Scholar One) to make it accessible to the handling editor of the manuscript.
~This editor will include the report in the letter to authors alongside the standard peer review reports."
15886863|NCT03751878|Behavioral|Standard Peer Review.|Manuscripts will undergo the usual peer review process.
15886864|NCT03751865|Behavioral|CBT|A total of 8 CBT sessions will be provided to the participants, each session lasts for approximately 1.5 hour.
15886865|NCT03751865|Behavioral|Psychoeducation|A total of 8 psychoeducation sessions will be provided to the participants, each session lasts for approximately 1.5 hour.
15886866|NCT03751852|Behavioral|Exercise Coaching|28 classes in 16 weeks
15886867|NCT03751852|Behavioral|Psychoeducation|28 classes in 16 weeks
15886868|NCT03751839|Diagnostic Test|Biochemical Tests|The investigators will perform blood tests in every participant.
15886869|NCT03751839|Diagnostic Test|Osteodensitometry|The investigators will perform an osteodensitometry in every participant.
15886870|NCT03751839|Diagnostic Test|Clinical Tests|The investigators perform the following clinical tests: vibration threshold test, monofilament test, chair rise test and timed up and go test in every participant.
15886871|NCT03751839|Diagnostic Test|HR-QCT|The investigators will perform HR-QCT measurements of the proximal femur and tibia in every participant.
15886872|NCT03751839|Diagnostic Test|HR-pQCT|The investigators will perform HR-pQCT measurements of the distal radius and distal tibia in every participant.
15886873|NCT03751826|Other|Incentivised network delivery of HIV-ST|Peer navigators are area based young community care givers, who support young people in their area in the uptake of multi-level HIV prevention provided through the department of health, social welfare and basic education, e.g. parenting support, gender-based violence interventions, safe spaces, mentoring, life-skills, and support around knowing and getting social entitlements and financial literacy. The peer navigators in the first intervention arm will encourage females aged 18-24 to use the HIV-ST to test for HIV themselves and in their peers and friends. They will be counselled to receive sexual and reproductive health services, contraception and condoms, HIV confirmatory testing and linkage to HIV care and prevention, including HIV Pre-Exposure Prophylaxis (PrEP), through referral slips to the study mobile clinical services.
15886874|NCT03751826|Other|Peer navigator delivery of HIV-ST|Peer navigators are area based young community care givers, who support young people in their area in the uptake of multi-level HIV prevention provided through the department of health, social welfare and basic education, e.g. parenting support, gender-based violence interventions, safe spaces, mentoring, life-skills, and support around knowing and getting social entitlements and financial literacy. The peer navigators in the second intervention arm will encourage females aged 18-24 to use the HIV-ST to test for HIV and then receive sexual and reproductive health services, contraception and condoms, HIV confirmatory testing and linkage to HIV care and prevention, including HIV Pre-Exposure Prophylaxis (PrEP), through referral slips to the study mobile clinical services.
15886875|NCT03751826|Other|standard of care|Peer navigators are area based young community care givers, who support young people in their area in the uptake of multi-level HIV prevention provided through the department of health, social welfare and basic education, e.g. parenting support, gender-based violence interventions, safe spaces, mentoring, life-skills, and support around knowing and getting social entitlements and financial literacy. The peer navigators in the standard of care arm encourage females aged 18-24 to test for HIV, receive sexual and reproductive health services, contraception and condoms, and link to HIV care and prevention, including HIV Pre-Exposure Prophylaxis (PrEP), through referral slips to the study mobile clinical services.
15886876|NCT03751813|Dietary Supplement|Supplement|Supplement will be given to this group to take daily for 8 weeks
15886877|NCT03751800|Drug|Chronic hormonal treatment|Drugs used in this study are described by the physicians during routine gynecological visits
15886878|NCT03751787|Other|cranial osteopathy|two sessions at three weeks intervals
15886879|NCT03751787|Other|comfort massage|manipulation, comfort massage, standardized and not affecting the skull
15886880|NCT03751774|Behavioral|MAMAACT|Post graduate training and health education materials
15886881|NCT03751761|Drug|durvalumab, tremelimumab, paclitaxel|Durvalumab, 1500 mg Q4W for 12 months Tremelimumab 75 mg Q4W for up to 4 doses/cycles Paclitaxel iv D1, D8, D15 Q4W (from 60mg/m2 to 80mg/m2)
15886882|NCT03751748|Device|AFR implantation|Implantation of atrial flow regulator (AFR) device
15886883|NCT03751748|Device|Sham procedure|Sham procedure to include cardiac catheterization and hemodynamic. Ongoing management at the discretion of the treating physician. Patient to undergo
15886884|NCT03751735|Biological|Wharton Jelly Mesenchymal stem cells|Intracavernous injection of Wharton Jelly Mesenchymal stem cells.
15886885|NCT03751709|Drug|Blinatumomab|Blinatumomab per package insert - via continuous infusion days 1-28 of Cycle 1 and Cycle 2, every 42 days.
15886886|NCT03751709|Other|Haplo-Mismatched Cell Therapy (HMCT)|HMCT infusion Cycle 1, Day 15 and Cycle 2, Day 8 & Day 15
15886887|NCT03751696|Behavioral|Group Coaching|4 sessions of 1-1.5-hour group coaching intervention within 8 weeks
15886888|NCT03751696|Behavioral|SMS self-help tips|4 mental well-being tips through sms within 8 weeks
15886889|NCT03751670|Other|Pulmonary Rehabilitation|Pulmonary Rehabilitation programmes will include breathing retraining and airway clearance techniques, exercises for thoracic mobility, muscle strength, cardiorespiratory exercise training, education and psychosocial support.
15886890|NCT03751670|Drug|Daily medical treatment|Patients will be treated with daily medication prescribed by the physician.
15886917|NCT03751488|Drug|Invega Sustenna 156 MG in 1 ML Prefilled Syringe|Single Dose at 156mg
15886891|NCT03751657|Drug|Insulin icodec|Insulin 287 once weekly subcutaneous (s.c.) injections at the starting dose of 70 units. Dose adjustment was done for the individual patient based on the three pre-breakfast self-measured plasma glucose values measured on two days prior to titration and on the day of the contact. The insulin dose adjustment should aim to reach an SMPG of 3.9-6.0 mmol/L (70-108 mg/dL)
15886892|NCT03751657|Drug|Placebo (insulin 287)|Participants will receive once weekly s.c. injections of placebo equivalent to insulin 287.
15886893|NCT03751657|Drug|Metformin|Metformin is considered as non investigational medicinal product. Subject will continue metformin at stable pre-trial dose.
15886894|NCT03751657|Drug|Dipeptidyl peptidase-4 inhibitors|Dipeptidyl peptidase-4 inhibitors are considered as non investigational medicinal products. Subject will continue dipeptidyl peptidase-4 inhibitor at stable pre-trial dose.
15886895|NCT03751657|Drug|Insulin glargine|Insulin glargine (100 U/mL) once daily s.c. injections at the starting dose of 10 units. Dose adjustment will be done for the individual patient based on the three pre-breakfast self-measured plasma glucose values measured on two days prior to titration and on the day of the contact. The insulin dose adjustment should aim to reach an SMPG of 3.9-6.0 mmol/L (70-108 mg/dL).
15886896|NCT03751657|Drug|Placebo (insulin glargine)|Participants will receive once daily s.c. injections of placebo equivalent to insulin glargine.
15886897|NCT03751644|Other|Electrical stimulation|Patients with systemic autoimmune myopathies will receive peripheral electrical stimulation in thigh muscles
15886898|NCT03751631|Drug|Phenylephrine 2.5%-tropicamide 1% ophthalmic solution|Fixed combination phenylephrine 2.5%-tropicamide 1% ophthalmic solution administered with a microdose dispenser
15886899|NCT03751631|Drug|Phenylephrine 2.5% ophthalmic solution|Phenylephrine 2.5% ophthalmic solution administered with a microdose dispenser
15886900|NCT03751631|Drug|Tropicamide 1% ophthalmic solution|Tropicamide 1% ophthalmic solution administered with a microdose dispenser
15886901|NCT03751618|Procedure|Hip arthroscopy|"Suture will be realized with two simple suture knots (non resorbable suture material). These suture knots will be performed at the end of hip arthroscopy. Correct capsular suture will be controlled under arthroscopy video.
~Patients randomized in control arm will not received capsular suture at the end of the procedure."
15886902|NCT03751605|Procedure|unipulmonary ventilation|observational study based on the computation of respiratory quotient in patient cohort treated by unipulmonary ventilation in routine thoracic surgery
15886903|NCT03751592|Drug|Chlorogenic acid|Chlorogenic acid for injection is polyphenols, micromolecular and un-endogenous substance. It might play the role of cancer treatment via balancing tumor micro-environmental immune status according to the stability and rationality of immunodeficiency and endogenous immune material expression around the tumor. Chlorogenic acid for injection is made from chlorogenic acid (purity≥98%) which is extracted from folium cortex eucommiae.Chlorogenic acid and its preparations have not been reported as chemical drug and marketed around the world.
15886904|NCT03751579|Procedure|coelioscopic surgery|observational study based on the computation of respiratory quotient in patient cohort treated by routine coelioscopic surgery
15886905|NCT03751566|Other|Acupuncture|"Schedule of the acupuncture:
~Acupuncture may be done ambulant or during hospitalisation . Acupuncture will be administered 1-3 times a week ( in case of severe toxicity and problems caused by the radiotherapy, it may continue also after the termination of the radiotherapy.) Acupuncture needles will be left for 5- 30 minutes, as per individual need of the patients.
~Acupuncture will be performed by a physician trained in acupuncture."
15886906|NCT03751566|Drug|Standard supportive therapy|Standard supportive therapy
15886907|NCT03751553|Drug|obsteric gel(k-Y jelly)|A sterile obstetric gel( K-Y Jelly 82GM; manufactured by Johnson&amp; Johnson) will be used for this trial. The obstetric gel is a birth gel with no pharmacologic effects that has a purely physical activity. Starting with the first vaginal examination the obstetric gel will be used. After each vaginal examination, 3-5 mL of obstetric gel will be introduced into the vaginal birth canal in the area in front of the child using the sterile obstetric gel applicator without any manipulation or massaging. Additional obstetric gel will be added 15-30 minutes after rupture of the membrane since the head of the child is visible, the mouth and nose region will be wiped clean. A dry towel will be used to liberate the child in order to prevent the child from slipping
15886908|NCT03751540|Procedure|ostap|this block is performed under general anesthesia in this patients for postoperative analgesia.
15886909|NCT03751540|Procedure|SIPB plus rectus sheath block|this block is performed under general anesthesia in this patients for postoperative analgesia.
15886910|NCT03751527|Device|ZENFLEX peripheral stent system|The ZENFLEX Peripheral Stent System is designed to deliver a self-expanding stent to the iliac artery, superficial femoral arteries and / or proximal popliteal arteries to improve luminal diameter. The self-expanding stent is composed of nickel titanium alloy (nitinol); contains a total of 12 tantalum / gold radiopaque markers and imparts an outward radial force on the luminal surface of the vessel to establish patency.
15886911|NCT03751514|Biological|Bordetella Pertussis B1917|"The B. pertussis isolate to be used in this human colonisation model is strain B1917, which is representative of current isolates in Europe. The strain, isolated in 2000 from a Dutch patient with B. pertussis disease, expresses Prn, PT and Filamentous Haemagglutinin (FHA). This strain has been extensively characterised in the mouse model as well as by proteomics and transcriptomics and has a closed genome available. It is fully sensitive to azithromycin in vitro.
~Providing there are no safety concerns the standard inoculum (SI) will be identified in a dose escalating or de-escalating experiment commencing at 103 colony forming units administered intranasally."
15886912|NCT03751514|Drug|Azithromycin 500 mg|To ameliorate risk of transmission of B. pertussis B1917 to the environment and household contacts, Azithromycin 500 mg once a day for 3 days will be given to eradicate colonisation with B. pertussis. The inoculum strain is fully sensitive to this antibiotic. Previous studies show that azithromycin eradicates colonisation in 97% of people in 48 hours.
15886913|NCT03751514|Other|Sterile Saline|To compare against B. pertussis, some volunteers will be enrolled onto the Sham arm. These volunteers will not receive B. pertussis but instead be given sterile saline
15886914|NCT03751501|Procedure|Indocyanine green-Guided Targeted Laser photocoagulation|Detection of macro-aneurysms by ICG angiography, laser photocoagulation and optional post-laser verification of the effectiveness of the photothrombosis by OCT.
15886915|NCT03751501|Procedure|Sham laser|Therapeutic procedure used in ophthalmology
15886916|NCT03751488|Drug|LY03010|Single Dose of LY03010 at 351 mg or 156 mg or 117mg
15886918|NCT03751475|Other|Nutritional Strategy - OptiMA|"All children with a MUAC<125mm or oedema will be treated with the same RUTF, according to a new dosage table based on the evolution of MUAC and weight during recovery (RUTF dosage prescribed is gradually reduced as weight and MUAC increase).
~All children will be followed-up for 6 months following randomization. They will have weekly outpatient visit in the health facility until they meet discharge criteria, and then a bimonthly community-based follow-up in their villages (vital & anthropometric status and referral to the health facility for appropriate nutritional/medical care if indicated)."
15886919|NCT03751475|Other|Effective nutritional standard strategy|"Children presenting with MUAC<115 or WHZ<-3 or nutritional oedema, will be treated with RUTF, according to the usual dosage table based on weight at each visit.
~All children (whether eligible for RUTF or not) will be followed-up for 6 months following randomization. Children eligible for RUTF at randomization will have a weekly outpatient visit in the health facility until they meet discharge criteria, and then a bi-monthly community-based follow-up in their villages (vital & anthropometric status and referral to the health facility for appropriate nutritional/medical care if indicated). Children not eligible for RUTF at randomization will benefit from this same monthly community-based follow-up."
15886920|NCT03751462|Device|Purkinjemeter|The Purkinjemeter will be used for assessment of IOL wobbling, tilt and decentration in patients with pseudoexfoliation syndrome or traumatic cataract
15886921|NCT03751449|Other|Educational Intervention|Receive nutrition education
15886922|NCT03751449|Behavioral|Exercise Intervention|Complete home-based aerobic and resistance exercise program
15886923|NCT03751449|Other|Quality-of-Life Assessment|Ancillary studies
15886924|NCT03751449|Other|Questionnaire Administration|Ancillary studies
15886925|NCT03751436|Drug|Enzalutamide|Given PO
15886926|NCT03751436|Drug|Venetoclax|Given PO
15886927|NCT03751423|Drug|PO Morphine|10-20mg oral morphine depending on such factors as weight (100-200mcg/kg), previous opiate exposure (opiate naïve vs opiate sensitized), and participant's previous experiences with opiate medications for painful procedures. Dosing will be determined at the discretion of the surgical provider in clinic that day, as per standard of care.
15886928|NCT03751423|Drug|IV Fentanyl|0.5-1mcg/kg IV fentanyl over 2 minutes repeated every 5 minutes as needed until appropriate analgesia is reached.
15886929|NCT03751423|Drug|IV Ketamine|200-500mcg/kg IV over 2 minutes repeated every 5 minutes as needed until appropriate analgesia is reached
15886930|NCT03751423|Drug|PO Placebo|A standard placebo pill, the same size, shape and colour of the oral morphine. The placebo will be administered to the participants randomized to the IV ketamine and IV fentanyl during pre-op in the same manner the oral morphine would be administered.
15886931|NCT03751423|Drug|IV Placebo|This normal saline will be administered to the participants randomized to the oral morphine group during the procedure in the same manner that IV fentanyl or IV ketamine would be administered.
15886932|NCT03751397|Other|blood test for renal biomarkers (creatinine, cystatin C, Neutrophil gelatinase-associated lipocalin, beta-trace protein, beta-2 microglobulin, uromodulin)|relationship between the different biomarkers by linear regression analysis is assessed; influence of demographic variables (age, body weight, body surface area) is investigated by multivariate regression.
15886933|NCT03751397|Other|urine test for renal biomarkers (creatinine, cystatin C, Neutrophil gelatinase-associated lipocalin, beta-trace protein beta-2 microglobulin, uromodulin, albumin)|relationship between the different biomarkers by linear regression analysis is assessed; influence of demographic variables (age, body weight, body surface area) is investigated by multivariate regression.
15886934|NCT03751384|Dietary Supplement|Möllers Omega-3 Ekstra Sterk|
15886935|NCT03751384|Dietary Supplement|Nutrifriend Cachexia|
15886936|NCT03751371|Device|Training with HWA device|Gait assessments will be conducted on participants randomized to the Trained group first during unassisted walking followed by HWA-assisted walking. Participants randomized to the Trained group will receive physical therapist supervised home and community-based walking training wearing the HWA device 2 times per week for 45-60 minutes for 8 weeks. Training will consist of walking in and outside of the home while encouraging larger and more symmetrical steps with practice of activities that challenge the person's balance and motor control. Rest breaks will be allowed as needed. If the therapist is unable to adjust the HWA to provide a safe gait pattern, the session will be ended and the device removed.
15886937|NCT03751371|Other|Usual Care|The Untrained group will continue their usual daily activities including any exercise regimen that they typically perform. However, they will be asked not to start any new exercise program during the study period.
15886938|NCT03751358|Procedure|Unilateral Erector spinae plane block|Magnetic résonance imaging
15886939|NCT03751345|Behavioral|Parenting Wisely|PW is a self-administered, interactive, multimedia online program. Parents will complete computer-administered sessions during in-person appointments.The program comes with a parent workbook so that parents can gain additional exposure to and practice with the skills. The complete PW program takes from 3 to 5 hours to complete depending on the users' speed and depth of use. Parents will be given a login at enrollment so that they have the option to practice sessions or view any additional sessions at home. Individual coaching sessions will take place in-person with parents. Coaching sessions are designed to tailor the PW skills to each parent's presenting concerns.
15886940|NCT03751332|Drug|Tacrolimus|Conversion from either cyclosporin or tacrolimus to tacrolimus modified release
15886941|NCT03751319|Other|CGA|Comprehensive Geriatric Assessment
15886942|NCT03751306|Procedure|Transcranial Photobiomodulation|"Photobiomodulation Rehabilitation:
~Diode laser, λ infrared = 810 nm, 0.028 cm2 beam area, 100 mW power, 3.5 W / cm2 power density, 3 Joules / dot and Energy Density of 107.1 J / cm2). Each point will be radiated for 30 seconds. The regions of irradiation will be in the middle cerebral arteries (points F7 and F8 will be used as reference point according to the International System 10-20 of the electroencephalogram) and anterior cerebral artery (AFz point according to the International System 10-20 of the electroencephalogram) ."
15886943|NCT03751306|Procedure|Transcranial Photobiomodulation (Placebo)|"Photobiomodulation Placebo Therapy:
~The same apparatus of the transcranial group photobiomodulation and the same irradiation points will be used. However, during the procedure, with the laser off."
15887036|NCT03750643|Drug|Placebo|Administered IV
15887037|NCT03750617|Diagnostic Test|pre-endoscopic screening risk assessment|pre-endoscopic screening risk assessment
15898404|NCT03662113|Dietary Supplement|water|5ml water prior to VCE
15886944|NCT03751306|Procedure|Cardiorespiratory Rehabilitation|"Cardiorespiratory Rehabilitation:
~Aerobic training on the treadmill will be reliated for 30 minutes using the support of the Rehabilitation and Physical Activity Station BrainMov® (equipment with 4 pillars condition that favors the suspension and stabilization of people with neuromuscular dysfunctions of mild to severe impairment. For monitoring, the training heart rate equation - Karvonen equation, effort perception scale - BORG, systemic arterial pressure, peripheral oxygen saturation, and patient signs and symptoms will be used. Subsequently, respiratory exercises and muscle strengthening of lower limbs, final relaxation and general guidelines will be performed for research volunteer and his / her relatives."
15886945|NCT03751293|Biological|C-CAR088|Autologous BCMA-directed CAR-T cells, single infusion intravenously at a target dose of 1.0-9.0 x 10^6 anti-BCMA CAR+ T cells/kg
15886946|NCT03751280|Device|PEAR-004|PEAR-004 (an investigational digital therapeutic) or sham (control) was downloaded to the subject's phone and then the assigned application was unlocked using a prescription code provided by Pear Therapeutics. As this was a digital therapeutic device study, dose or mode of administration is not applicable.
15886947|NCT03751280|Device|Sham|PEAR-004 (an investigational digital therapeutic) or sham (control) was downloaded to the subject's phone and then the assigned application was unlocked using a prescription code provided by Pear Therapeutics. As this was a digital therapeutic device study, dose or mode of administration is not applicable.
15886948|NCT03751267|Procedure|Tuina (massage)|Tuina is massage based on Traditional Chinese Medicine (TCM) principles.
15886949|NCT03751254|Device|Stellaris Elite|The Stellaris and the Stellaris Elite platform will be used in myopic patients (axial length > 25.0 mm) during cataract surgery
15886950|NCT03751241|Device|EyeTracker|The EyeTracker is used to determine reading quality of patients with different intraocular lens types (EROV, monofocal, minimonovision)
15886951|NCT03751228|Drug|BMS-986165|Swish and expectorate after tasting
15886952|NCT03751228|Drug|Active Pharmaceutical Ingredient|Swish and expectorate after tasting
15886953|NCT03751215|Procedure|Cataract surgery|During cataract surgery the patient is implanted with the monofocal IOL Clareon in one eye and the monofocal IOL AcrySof in the contralateral eye
15886954|NCT03751202|Drug|Fluticasone propionate 500 mcg and salmeterol xinafoate 50 mcg|2 inhalations of Test and Reference product in each study period
15886955|NCT03751202|Drug|ADVAIR DISKUS|2 inhalations of Test and Reference product in each study period
15886956|NCT03751176|Drug|Panitumumab|Panitumumab 6 mg/kg will be administered by intravenous (IV) infusion over 60 min on days 1 and 14 of every cycle just before administration of chemotherapy
15886957|NCT03751176|Drug|Irinotecan|Irinotecan 180 mg/m2 will be administered as IV infusion over 90 min on day 1
15886958|NCT03751176|Drug|Folinic acid|Folinic acid 200-400 mg/m2 will be administered as IV infusion over 2 hours on day 1
15886959|NCT03751176|Drug|5-FU|5-FU will be administered IV 400 mg/m2 bolus followed by 2400 mg/m2 IV continuous infusion over 46-48 hours on days 1 and 2
15886960|NCT03751163|Drug|Tranexamic Acid Oral Product|Encapsulated tranexamic acid 250 mg
15886961|NCT03751163|Drug|Hydroquinone 4% Cream|Hydroquinone 4% Cream
15886962|NCT03751163|Other|Sunscreen|Sunscreen SPF 30
15886963|NCT03751163|Device|Placebo|Encapsulated placebo
15886964|NCT03751150|Other|Exercise program|The runners will be asked to perform the training program twice a week. The intervention consist of muscle control and foam rolling exercises for the lower extremities.
15886965|NCT03751124|Drug|Relugolix|Relugolix 40 mg tablet administered orally once daily
15886966|NCT03751124|Drug|Estradiol/norethindrone acetate|Capsule containing co-formulated tablet of estradiol 1.0 mg and norethindrone acetate 0.5 mg administered orally once daily
15886967|NCT03751124|Drug|Placebo for relugolix|Placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor
15886968|NCT03751124|Drug|Placebo for E2/NETA|Placebo capsule administered orally once daily and designed to match the E2/NETA capsule in size, shape, color, and odor
15886969|NCT03751111|Drug|Naloxone|Naloxone at an sublingual dose of 40 mg daily for one week will be given to each subject. Subjects will self-administer the drug at supervision in the primary care center.
15886970|NCT03751111|Drug|Placebo|Placebo will be given to each subject for one week. Subjects will self-administer the drug at supervision in the primary care center.
15886971|NCT03751098|Drug|Phenylephrine 2.5%-tropicamide 1% ophthalmic solution|Fixed combination phenylephrine 2.5%-tropicamide 1% ophthalmic solution administered with a microdose dispenser
15886972|NCT03751098|Drug|Placebo|Eyewash administered with a microdose dispenser
15886973|NCT03751085|Device|AW frame|AW stereotactic frame for intracranial lesion biopsy
15886974|NCT03751059|Drug|Bromfenac 0.07% Oph Susp|Bromfenac 0.07% Oph Susp to be used post-operatively (week 1 to month 3) by one treatment group.
15886975|NCT03751059|Drug|Dexamethasone|Topical dexamethasone to be used by all study participants for one week pre-trabeculectomy and by all study participants for one week post-trabeculectomy. At one week post-op, one of the treatment groups will continue to dose with dexamethasone.
15886976|NCT03751046|Behavioral|Trial-Based Cognitive Therapy|Participants in the TBCT intervention arm will have 14 (fourteen) psychotherapy sessions over a period of 7 (seven) months. The frequency of the intervention is biweekly with a duration of approximately 90 minutes per session. We will have10 groups with 5 participants each. All participants will practice the learned techniques during the meetings, have a manual with a description summary of the sessions and the activities to practice at home. The main TBCT techniques that will be used are case conceptualization, intrapersonal thought record, consensual role-play, action plan, trial-based thought record and trial-based metacognitive awareness.
15886977|NCT03751046|Other|Control group. Standard healthcare.|"Participants with therapeutic failure, receiving the standard healthcare in the HIV / AIDS Program, which includes at least a half-yearly psychology and pharmaceutical chemist consultations (approximately half an hour each).
~The purpose of these consultations is to approach the importance of adherence and psychoeducation on HIV"
15886978|NCT03751033|Device|BSS|Intraoperative aberrometry measurements for BSS will be performed.
15886979|NCT03751033|Device|DiscoVisc|Intraoperative aberrometry measurements for DiscoVisc will be performed.
15887137|NCT03750006|Behavioral|Short session HIIT|Individually tailored short session high intensity interval training session 3 times per week for 12 weeks on a recumbent exercise cycle.
15886980|NCT03751020|Behavioral|Expressive Writing (EW) Intervention|The EW intervention will utilize the procedures piloted earlier with gay and bisexual male college students in urban and rural regions of the US. In this condition, participants will be instructed to write for 20 minutes across three consecutive days in a free-form manner about the most stressful or traumatic LGB-related event that they have encountered.
15886981|NCT03751020|Behavioral|Self-Affirmation (SA) Intervention|The SA intervention will ask participants to read a brief description, over the course of 3 consecutive days, of a (hypothetical) LGB youth who is facing minority stress. Each day's description will contain a different LGB youth facing a different stigma-related stressor derived from Phase 1 and 2 interviews. Participants will then be asked to write a letter for 20 minutes to advise the LGB youth how best to cope with minority stress drawing on their personal experiences.
15886982|NCT03751020|Other|Control|Participants randomly assigned to the control condition will be asked to write about what they have done since waking up that morning for 20 minutes across 3 consecutive days. This control matches the time and activity of the EW and SA arms and has been implemented across dozens of EW and SA studies.
15886983|NCT03751007|Biological|AG019 - Low Dose|Solid, orally administered capsule - 2 capsules per day for 1 day (single dose) or 8 weeks (repeat dose)
15886984|NCT03751007|Drug|Teplizumab|Daily IV infusions of Teplizumab during the first 12 days of AG019 treatment. Total cumulative dose is approximately 17mg (dose calculation based on body surface area).
15886985|NCT03751007|Drug|Placebo-AG019|Formulated identically to AG019 with the active ingredient removed.
15886986|NCT03751007|Drug|Placebo-Teplizumab|Formulated identically to teplizumab with the active ingredient removed.
15886987|NCT03751007|Biological|AG019 - High Dose|Solid, orally administered capsule - 6 capsules per day for 1 day (single dose) or 8 weeks (repeat dose)
15886988|NCT03751007|Biological|AG019 - Low or High Dose|Solid, orally administered capsule - 2 or 6 capsules per day for 8 weeks (repeat dose).
15886989|NCT03750981|Behavioral|12 week pilot intervention study.|Participants will begin a 12-week high-intensity functional training program conducted at CrossFit® in the D, located in downtown Detroit, Northville Athletix in Northville and Five Lakes CrossFit® in Farmington Hills.
15886990|NCT03750968|Drug|Carotenoid Group|DHA Softgel active ingredients: DHA 200 mg, d-Alpha Tocopherol 30 IU, Lutein 6mg
15886991|NCT03750968|Dietary Supplement|Control Group|DHA Softgel active ingredients: DHA 200 mg, d-Alpha Tocopherol 30 IU
15886992|NCT03750955|Device|Plaque induced gingivitis|Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene cessation utilizing localized stent-induced biofilm overgrowth model (SIBO), will manipulate the participants' oral environment by leading to reversible inflammation of the gingival tissues.
15886993|NCT03750955|Device|Oral hygiene maintenance|Non-invasive microimaging (OTC device) of gingival tissue where oral hygiene has been maintained by tooth brushing with fluoride toothpaste and flossing twice daily.
15886994|NCT03750942|Device|Adhesix® monofilament polypropylene mesh (Bard Davol)|The intervention group will receive preventive mesh placement and in the control group no mesh is placed, the stoma is closed according to standard practise.
15886995|NCT03750929|Other|Combined acute physical exercises (strength and aerobic)|Patients will be submmitted to combined acute physical exercises (strength and aerobic)
15886996|NCT03750916|Drug|Anlotinib Hydrochloride plus Docetaxel|Anlotinib Hydrochloride (12mg QD PO d1-14, 21 days per cycle) and Docetaxel (75mg/m2 IV d1)
15886997|NCT03750903|Behavioral|Aerobic Exercise|Participants will engage in an aerobic exercise program meeting thrice weekly for a period of 12 weeks.
15886998|NCT03750903|Behavioral|Stretching and Balance Training|Participants will engage in a balance and stretching comparator condition meeting thrice weekly for 12 weeks.
15886999|NCT03750877|Procedure|median approach|spinal anesthesia with median approach; is the known classical method and it is aimed to reach the spinal area from the middle line.
15887000|NCT03750877|Procedure|paramedian approach|In spinal anesthesia with a paramedian approach, 1 cm lateral and 1 cm caudal to reach the spinal area.
15887001|NCT03750864|Behavioral|ACT-LCS Therapy|All participants in Stage 1, and those randomized to the intervention condition in Stage 2, will receive the Acceptance & Commitment Therapy for Lung Cancer Stigma (ACT-LCS) intervention. The ACT-LC intervention is designed to be delivered as 6 sessions of individual psychotherapy with a trained psychotherapist at a weekly or bimonthly rate, delivered either in person or over the phone. The treatment manual is based in Acceptance and Commitment Therapy (ACT). Therapists are instructed to begin treatment with Module 1. Modules 2-5 can then be administered in any order at the discretion of the therapist, based upon what the therapist thinks is most likely to be helpful to the patient. Module 6 is the final session of treatment.
15887002|NCT03750851|Other|Placebo|In this group, a water soluble gel without addition any desensitizing agent (K-Y®, Johnson & Johnson, Brazil) was applied to hypersensitive dentin. The GPlacebo volunteers were submitted to the application of placebo dentifrice on the vestibular surfaces of hypersensitive teeth with the aid of a microbrush applicator (Microbrush, 3M ESPE, Brazil) and left undisturbed on the surface during 05 minutes. Then, a rubber cup (Unid Microdont, Brazil) mounted on a low speed handpiece (500, Kavo, Germany) was used to scrub the placebo gel for 20 seconds on each tooth.
15887003|NCT03750851|Other|CPPACPF|In this group, a toothpaste MI Paste Plus™ (Recaldent™, GC América, USA) was applied to hypersensitive dentin. The GCPPACPF volunteers were submitted to the application of the paste dentifrice on the vestibular surfaces of hypersensitive teeth with the aid of a microbrush applicator (Microbrush, 3M ESPE, Brazil) and left undisturbed on the surface during 05 minutes. Then, a rubber cup (Unid Microdont, Brazil) mounted on a low speed handpiece (500, Kavo, Germany) were used to scrub the desensitizing gel for 20 seconds on each tooth.
15887004|NCT03750851|Other|Laser|In this group, the diode laser with an active medium of Asauxa bauxite (Photon Lase III, DMC Equipamentos Ltda, Brazil) was applied in hypersensitive dentin. GLaser received the laser application using the infrared light spectrum with wavelength of 808 nm with its active AsGaAl medium in two points of the vestibular face of the hypersensitive teeth. It was applied at each point 60 J / cm², for 16 seconds. The laser was applied in 3 sessions with a time interval of 24 hours between them.
15887098|NCT03750279|Other|LLLT|- LLLT (60 mW mean output per probe, 904 nm wavelength) applied to the knee in adherence with the recommendations by World Association for Laser Therapy, in terms of dosage per treatment spot.
15887099|NCT03750279|Other|Sham LLLT|- Same procedure as in the LLLT group with the exception of laser irradiation (0 mW mean output power).
15887005|NCT03750851|Other|LaserCPPACPF|In this group the laser + CPP-ACPF was applied. The laser was used with light intensity medium Asauxa (Photon Lase III, DMC Equipamentos Ltda, Brazil) and a toothpaste containing CPP-ACPF MI Paste Plus™ (Recaldent™, GC América, USA) was applied in hypersensitive dentin. GLaserCPPacpf first named a toothpaste application and them the laser application, according to the manufacturer's recommendations.
15887006|NCT03750838|Behavioral|Text Messaging Intervention|The content for the TM Intervention will be designed to be non-confrontational in tone, seek to increase motivation to drink lightly or not at all, and based both on general information about light and non-drinking as well as information provided during the baseline assessment.
15887007|NCT03750838|Behavioral|Active Control|Participants will receive a series of TM based on nutritional data on the same schedule as those in the TM intervention and will complete a 6 week post-intervention assessment as well as all follow-ups.
15887008|NCT03750825|Device|NIDA Standard Research E-cigarette (SREC)|Smokers will switch to NIDA Standard Research E-cigarette (SREC).
15887009|NCT03750812|Behavioral|Aerobic Exercise|Medium-intense 60% heart rate reserve (HRR) aerobic exercise on a treadmill for 30 minutes
15887010|NCT03750812|Behavioral|Watching television|Sitting and watching television for 30 minutes
15887011|NCT03750799|Device|Whole body vibration|Whole body vibration was applied on the right lower extremity in the experimental group.
15887012|NCT03750799|Device|Sham vibration|Sham vibration was applied on the right lower extremity in the Control sham group
15887013|NCT03750786|Drug|Arfolitixorin|Arfolitixorin and 5-FU and Oxaliplatin and Bevacizumab
15887014|NCT03750786|Drug|Leucovorin|Leucovorin and 5-FU and Oxaliplatin and Bevacizumab
15887015|NCT03750773|Drug|Gabapentin 600mg|Subject is given Gabapentin 600mg every 8 hours x 48 hours postoperatively for pain control.
15887016|NCT03750773|Drug|Placebo oral capsule|Subject is given a Placebo capsule every 8 hours x 48 hours postoperatively for pain control.
15887017|NCT03750760|Drug|Alirocumab|PCSK9 (Proprotein Convertase Subtilisin Kexin Type 9) inhibitor antibody
15887018|NCT03750760|Drug|Atorvastatin 80mg|3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors (statin)
15887019|NCT03750760|Drug|Ezetimibe 10mg|Cholesterol absorption inhibitor
15887020|NCT03750747|Device|Pulse Oximeter|SpO2 will be measured using a handheld PO device (selected for this study) applying the low noise cabled sensor. For patients weighing <10 kg, the sensor will be placed on the big toe. For patients weighing >10 kg, the sensor will be placed on an index finger. In case of failure in the first attempt, the alternate toe or index finger will be tried (second attempt). First, the sensor will be placed on toe or index finger and then the PO will be powered-on. A stable Sp02 reading will be considered to be obtained if SpO2 reading is stable by ±1 % for at least 10 seconds and the device signal strength is displayed to be adequate (green signal). Second attempt will be warranted if a stable reading is not obtaining within 1-2 minutes.
15887021|NCT03750734|Diagnostic Test|Bronchoscopy|Flexible bronchoscopy will be performed under sedation (typically a sedative such as intravenous midazolam and/or fentanyl) with local anaesthetic to the throat and vocal cords. Bronchial epithelial tissue (via bronchial brushing and biopsy forceps) and bronchial lavage samples will be taken for analysis.
15887022|NCT03750734|Diagnostic Test|Blood test|Peripheral blood will be taken to collect peripheral blood monocytes, which will then allow the production of induced pluripotent stem cell derived bronchial epithelial tissues.
15887023|NCT03750721|Other|Role of rifampin in staphylococcal PJI|the aim is to determine if the dose and the duration of rifampin influenced the prognosis
15887024|NCT03750708|Device|Ara® KOLIBREE tooth brush|"Use of the Ara® KOLIBREE tooth brush by the child one month before alveolar bone graft up to the time of surgery.
~The Ara® KOLIBREE tooth brush saves brush tracking data."
15887025|NCT03750695|Behavioral|Resistance exercise|One acute exercise session of resistance exercise (40 minutes including 3 sets of 8-10 repetitions at the participant's 10 repetition maximum load of upper and lower extremity exercise
15887026|NCT03750695|Behavioral|Aerobic Exercise|One acute session of aerobic exercise (40 minutes of cycle ergometry exercise at 70% of VO2peak)
15887027|NCT03750695|Behavioral|Rest|40 minutes of quiet rest in semi-recumbent position
15887028|NCT03750682|Other|Physical Activity (PA) Intervention|The PA intervention will consist of a twice per week group- based moderate-intensity multimodal program that includes aerobic, strength, flexibility, and balance training, as previously described. The Community Health Promoter will be trained and certified by Dr. Reid to deliver the PA intervention. PA will be conducted at the Holland Street Senior Center in Somerville, MA. The center is equipped with a large dining hall and corridors which will be utilized to perform the various components of the PA intervention for ENGAGE-B. This real-world approach was shown to be safe, feasible and effective in the initial ENGAGE study among older adults with severe mobility-limitations. Throughout PA, walking will be the primary mode of exercise, given its widespread applicabilityThe study staff will administer an Adverse Event/Concomitant Medication Questionnaire biweekly to all PA subjects.
15887029|NCT03750682|Other|Healthy Aging Education (HE) Intervention|"The HE intervention will also be conducted at the Holland Street Senior Center in Somerville, MA. Participants will receive bimonthly lifestyle counseling workshops in a group setting. Participants will receive information on a variety of topics of relevance to older adults (e.g., nutrition for brain health, effective negotiation of the health care system, dietary guidelines for older adults, safe travel, age-appropriate preventive services and screenings, resources for reliable health information, etc.). All intervention materials will be submitted for IRB approval prior to the presentation. In addition to educational offerings, an instructor led program (5-10 minutes) of gentle upper extremity stretching exercises and relaxation techniques are to be performed during each class.
~The study staff will administer an Adverse Event/Concomitant Medication Questionnaire biweekly to all HE subjects."
15887030|NCT03750669|Drug|AG regimen|Combination of Nab-paclitaxel 125 mg/m^2 and Gemcitabine 1000 mg/m^2
15887031|NCT03750669|Drug|mFolfirinox|Folic acid 400mg/m^2, 5- fluorouracil 2400mg/m^2 for 46h, irinotecan 135mg/m^2 and oxaliplatin 68mg/m^2
15887032|NCT03750656|Drug|Hyoscyamine|Patients will be randomized to receive hyoscyamine for lower urinary tract symptoms are placement of ureteral stent
15887033|NCT03750656|Drug|Tamsulosin|Patients will be randomized to receive tamsulosin for lower urinary tract symptoms are placement of ureteral stent
15887034|NCT03750643|Drug|LY3454738|Administered IV
15887035|NCT03750643|Drug|LY3454738|Administered SC
15887038|NCT03750604|Diagnostic Test|visceral fat obesity (surface area and function)|"WC is evaluated at the midpoint between the lower border of the rib cage and the iliac crest. The surface area of subcutaneous fat (S) and visceral (V) is calculated using slices between L4-L5 and umbilicus according to ct detection fat methods Also bladder wall thickness was calculated by measuring average bladder wall thickness at three different levels.
~Subcutaneous fat to visceral fat ratio was calculated. Assays for serum total and high-density lipoprotein cholesterol (HDL-C) and triglyceride (TG) levels were performed in the hospital's chemistry laboratory with an autoanalyzer. VAI was calculated for females as this formula like the previous study.
~VAI: WC/ [36.58 + (1.89 × BMI)] × TG/0.81 × 1.52/HDL.
~And in males:
~VAI: WC / [39.68 + (1.88 x BMI)] x TG/ 1.03 x 1.31/ HDL WC: waist circumference, BMI: body mass index, TG: triglyceride, HDL: high-density lipoprotein"
15887039|NCT03750591|Drug|Herbal medicine|Herbal medicine will be mainly administered in water-based decoction (120ml) and dried powder (2g) form (the ingredients are mainly, but not restricted to: Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, Saposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycine max, Atractylodes japonica).
15887040|NCT03750591|Procedure|Chuna manual therapy|"Chuna is a Korean spinal manipulation that incorporates spinal manipulation techniques for joint mobilization involving highvelocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement.
~Chuna manipulation will be administered at the physician's discretion."
15887041|NCT03750591|Procedure|Bee venom pharmacopuncture|"Bee venom pharmacopuncture will be administered only after confirming a negative response to hypersensitivity skin test.
~Diluted bee venom (saline:bee venom ratio, 10,000:1) filtered for allergens will be injected at 4-5 acupoints proximal to the dysfunctional site at the physician's discretion. Each acupuncture point will be injected to a total of 0.5-1 cc using disposable injection needles (CPL, 1 cc, 26gauze(G) x 1.5 syringe, Shinchang medical co., Korea)."
15887042|NCT03750591|Procedure|Pharmacopuncture|Pharmacopuncture consisting of select herbal ingredients will be administered at Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26gauze(G) x 1.5 syringe, Shinchang medical co., Korea).
15887043|NCT03750591|Procedure|Acupuncture|Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
15887044|NCT03750591|Procedure|Electroacupuncture|Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
15887045|NCT03750591|Procedure|Cupping|Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.
15887046|NCT03750591|Other|Other intervention(s)|Patients will be allowed any other additional intervention(s) as deemed necessary by the attending physician regardless of type or dose, and patterns of use will be investigated and recorded as an pragmatic clinical study.
15887047|NCT03750578|Behavioral|Virtual Reality goggle (Oculus Rift ® Helmet)|as described
15887048|NCT03750565|Drug|TD-1473 - Dose A|oral capsule/tablet, QD
15887049|NCT03750565|Drug|TD-1473 - Dose B|oral capsule/tablet, QD
15887050|NCT03750565|Drug|TD-1473 - Dose C|oral capsule/tablet, QD
15887051|NCT03750565|Drug|Placebo|oral capsule/tablet, QD
15887052|NCT03750552|Drug|ampreloxetine|Oral tablet, QD
15887053|NCT03750552|Drug|Placebo|Oral tablet, QD
15887054|NCT03750539|Radiation|Standard radiotherapy|External Bean Pelvic Radiation: 50 Gy in 15 fractions, with weekly cisplatin.
15887055|NCT03750539|Radiation|hypofractionated radiotherapy|External Bean Pelvic Radiation: 37.5 Gy in 15 fractions, with weekly cisplatin.
15887056|NCT03750539|Procedure|Radical hysterectomy|Radical hysterectomy and pelvic and paraaortic lymph node resection
15887057|NCT03750526|Behavioral|rTMS and AR|rTMS performs 1Hz,15 minutes real rTMS. AR intervention contains weight-shift exercise, strengthening of lower limb and balance training for 45 minutes.
15887058|NCT03750526|Behavioral|Sham rTMS and AR|Sham rTMS applies 1Hz, 15 minutes sham rTMS. AR intervention includes weight-shift exercise, strengthening of lower limb and balance training for 45 minutes.
15887059|NCT03750526|Behavioral|AR|AR intervention contains weight-shift exercise, strengthening of lower limb and balance training for 60 minutes.
15887060|NCT03750526|Behavioral|Conventional physiotherapy|Conventional physiotherapy includes rolling, sitting, balance exercise, standing, overground walking, facilitation of the paretic limbs, and so on for 60 minutes.
15887061|NCT03750513|Radiation|Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy|Given LET optimized IMPT
15887062|NCT03750513|Other|Quality-of-Life Assessment|Ancillary studies
15887063|NCT03750513|Other|Questionnaire Administration|Ancillary studies
15887064|NCT03750500|Device|Biofeedback device|12-week exercise program performed through the device
15887065|NCT03750500|Behavioral|Education on falls risk|Education on falls risk factors and how to minimize them
15887066|NCT03750500|Other|Medication review|Medication will be reviewed to reduce sedative drugs and minimize interactions
15887067|NCT03750500|Diagnostic Test|Visual and auditory screening|Patients will go through visual and auditory screening as part of their regular care
15887068|NCT03750487|Behavioral|e-screening & brief intervention (e-SBI)|Computer-delivered screening and brief motivational intervention targeting alcohol and drug use + goal-setting and content reinforcement
15887069|NCT03750487|Behavioral|Control e-SBI|Computer-delivered screening and brief motivational intervention targeting healthy eating and exercise
15887070|NCT03750474|Diagnostic Test|magnetic resonance elastography and shear wave elastography|magnetic resonance elastography and shear wave elastography of the back muscles
15887071|NCT03750461|Device|Mesh Implantation|Implantation of permanent mesh (BARD Soft Mesh) into the abdominal wall for reinforcement to prevent hernia formation
15887097|NCT03750279|Other|Exercise therapy|"5 min. warm up with light exercises for the lower limb prior to strength/endurance exercise therapy.
~Strength/endurance exercise therapy including level 1 or 2 per session:
~Level 1: Pelvic lifts (2x15 rep.), one-legged knee bends (2x10 rep. per leg), hip abductions (2x10 rep. per leg). The participants may progress from level 1 to level 2.
~Level 2: Pelvic lifts (3x15 rep.), one-legged knee bends (3x10 rep. per leg), hip abductions (2x10 rep. per leg), sideways slide (2x10 rep. per leg), and backwards slide (2x10 rep. per leg). The participants may regress from level 2 to level 1."
15887138|NCT03749993|Other|Screening|Use of bpMRI for opportunistic prostate cancer screening.
15887072|NCT03750448|Other|Telerehabilitation|The telerehabilitation intervention is based on sensor technology, developed by ICURA. The technology consists of motion sensors that can measure and analyse the quantity and quality of the exercises, and a mobile application that can guide the patients with visual response. A unique feature of ICURA trainer allows the physiotherapist to remotely supervise the individual patients exercise adherence and progress. The patients will receive a suitcase with five sensors (to be placed bilaterally on lower legs, thighs and one around the waist), a smartphone to record the exercises and a charging station free of charge during the 6-week intervention. At the end of the intervention the material will be returned at the first follow-up (t1). For more information please visit https://icura.dk.
15887073|NCT03750448|Other|No intervention|Patients allocated to the no intervention group will receive encouragement to stay active and be encouraged to gradually return to activities of daily living. This will be the only exercise-encouragement given to the no-intervention group.
15887074|NCT03750448|Other|Unsupervised rehabilitation|The unsupervised rehabilitation group will receive a written exercise program in order to perform daily exercises at home. The exercise program will be made using Exorlive (for more information about Exorlive please visit https://www.exorlive.com). In addition to the written program, patients will able to use a link provided to see small video-instructions on the internet of each exercise on the program. No feedback or supplementary instructions will be given after the initial face-to-face appointment.
15887075|NCT03750435|Procedure|AF ablation or left-sided AT ablation|According to the type of AF/AT, single or double transseptal and subsequent catheter ablation in the left atrium using radiofrequency will be performed.
15887076|NCT03750422|Device|Picoway|1064/532nm picosecond laser
15887077|NCT03750422|Other|Stratacel|a self-drying, bacteriostatic, transparent silicone gel with anti-inflammatory properties
15887078|NCT03750422|Other|Aquasonic|clear ultrasound gel
15887079|NCT03750409|Device|Helmet|The portable device covers the head and weighs about 3.5 lb., and is made of light-weight, durable plastic, it is placed on the head with eye panels facing forward. Elastic straps holding the arrays together easily expand to conform to each subjects' head. Patients may notice slight warming of scalp after usage. This warming effect is similar to wearing a regular motorcycle helmet for a similar duration.
15887080|NCT03750396|Procedure|Surgical resection|Surgical resection for their metastatic lesions will be performed. Achievement of tumor-free margin is not mandatory.
15887081|NCT03750396|Radiation|Stereotactic body radiotherapy|Deliver appropriate metastasis directed radiotherapy while minimizing exposure of surrounding normal tissues. Total radiation dose and fractions are various according to metastatic lesions (57~97.5Gy/6~10 Fraction).
15887082|NCT03750396|Procedure|Radiofrequency ablation|RFA is a localized thermal treatment technique designed to induce tumor destruction by heating the tumor tissue to temperatures that exceed 60℃. The alternating current of radiofrequency waves passing down from an uninsulated electrode tip into the surrounding tissues generates changes in the direction of ions and creates ionic agitation and frictional heating. This tissue heating then drives extracellular and intracellular water out of the tissue, resulting in tissue destruction by coagulative necrosis.
15887083|NCT03750383|Drug|EDP-938|Subjects will receive EDP-938 once daily on Day 1 and Day 5 (Part 1)
15887084|NCT03750383|Drug|EDP-938|Subjects will receive one dose of EDP-938 on Day 1 and Day 8 (Part 2)
15887085|NCT03750383|Drug|Cyclosporine|Subjects will receive one dose of cyclosporine on Day 5
15887086|NCT03750383|Drug|Prednisone|Subjects will receive prednisone once daily from Day 5 to Day 14
15887087|NCT03750370|Device|Doppler ultrasound|Colored Doppler Sonography is well established to illustrate microvascularity and therefore perfusion of the testis. The arterial flow velocities (peak systolic velocity [PSV] and end diastolic velocity [EDV]) and the resistance indices against this flow (resistive index [RI] and pulsatility index [PI]) in the testis can be measured with this technique.
15887088|NCT03750357|Device|Primary Relief v 2.0|To prove the effectiveness of Post Operative Pain Solution using Primary relief v 2.0 by Percutaneous Electrical Nerve Stimulation in the auricle.
15887089|NCT03750344|Device|Diagnostic test|Comparison of respiratory rates in normal subjects as observational with end tidal CO2. No treatment or interventions will be performed
15887090|NCT03750331|Other|Ap'Telecare|an internet application on a computer, tablet or smartphone
15887091|NCT03750331|Other|traditional schedule|a group of renal transplant outpatients consulting their Transplant Centre following a traditional schedule
15887092|NCT03750318|Device|Vital sign monitoring|Each patient will be set up for monitoring on admission. Duration of opioid therapy for post-operative in-patients may range from 1-3 days. Once opioid therapy is no longer required, Aingeal monitoring will be ended and each patient would be encouraged to have at least 1 day Aingeal monitoring to be recorded during the study. De-identified log files will be extracted from the Surveillance Station and reprocessed to produce counts of the number of alarms raised during monitoring. A sample of the data will be reviewed to determine whether cardiac and respiratory alarms are defined as True or False, with an overall Alarm Rate per patient per day and False Positive Alarm Rate per patient per day derived. Vital sign trend graphs for each patient will be produced.
15887093|NCT03750305|Other|imagery-focused Cognitive Therapy|"In depth identification phase: Therapists and patient collaboratively map out difficulties and pinpoint a treatment focus.
~Imagery interventions: The imagery intervention consists of metacognitive imagery rescripting or promoting positive imagery or competing tasks (or a combination of these).
~Consolidation: Consist of fine tuning the strategies, relapse prevention using a video diary."
15887094|NCT03750305|Other|TAU|Psycho-education is offered in groups, using the format described by Honig (Postma, Honig, & van Gent, 2008).
15887095|NCT03750292|Device|HEPAirX air filter|It is a trademarked, patented (U.S. Patent # 7,802,443), U.S. FDA approved Class II medical re-circulating air cleaner, built by Air Innovations, Inc. (North Syracuse, NY) to provide improved indoor air quality in the bedrooms of asthmatic children. Units to be used in the proposed study have a 99.97% efficient filter for particles 0.3 µm in size. The device provides a clean air delivery rate (CADR) of 9 per hour with 1.8 of them being outdoor air.
15887096|NCT03750292|Device|control air filter|A placebo mode was added to the HEPAirX to provide only recirculation (without filtration or ventilation using outdoor air) and temperature control of the room air. The placebo filter is made of metal.
15887242|NCT03749161|Device|Monofocal IOL|Lentis L-313, monofocal IOL
15887243|NCT03749148|Drug|Dupilumab|anti-IL4-Receptor alpha
15887100|NCT03750266|Other|No intervention data collected through routine scans|No intervention, we wish to use the images a mother would have done as part of her normal medical care and make both 3D animations and 3D models of the baby and it's CDH.
15887101|NCT03750253|Other|Extracorporeal Shock Wave Therapy|Extracorporeal Shock Wave Therapy will be used for pain-relief after arthroscopy for osteochondral lesions of the talus
15887102|NCT03750240|Diagnostic Test|Sodium (Na) Magnetic Resonance Imaging (MRI)|"Two Na data will be acquired:
~FLORET without Inversion Recovery (IR), and
~FLORET with IR"
15887103|NCT03750240|Diagnostic Test|Dynamic Contrast- Enhanced (DCE) MRI|DCE MRI will be acquired subsequent to Na MRI to prevent influence of the contrast agent on 23 Na data
15887104|NCT03750227|Procedure|Conventional Surgery|Undergo surgery
15887105|NCT03750227|Other|Quality-of-Life Assessment|Ancillary studies
15887106|NCT03750227|Other|Questionnaire Administration|Ancillary studies
15887107|NCT03750227|Radiation|Stereotactic Radiosurgery|Undergo stereotactic radiosurgery
15887108|NCT03750214|Device|Biop Colposcopy System|"The procedure stages:
~Scanning of the cervix - the cervix is scanned using the micro colposcope probe unit, to produce a total of 51 micro-images and one macro image from the panoramic camera.
~Colposcopy exam - during the standard colposcopy exam, the doctor acquires a panoramic image of the cervix with the digital colposcope.
~A questionnaire completed by the subject after the Biop procedure, with regards to any unusual sensations or events experienced during the procedure.
~A questionnaire completed by the user after the Biop procedure, with regards to system usage
~Image Registration analysis"
15887109|NCT03750201|Device|Direct Selective Trabeculoplasty|Laser surgery by automated direct automated SLT device to lower intraocular pressure
15887110|NCT03750201|Device|Selective Trabeculoplasty|Laser surgery by standard SLT device to lower intraocular pressure
15887111|NCT03750188|Drug|ProHance|0.1 mmol/kg ProHance intravenous injection
15887112|NCT03750175|Other|Plasma circulating DNA analysis|Clinical utility of ctDNA analysis for treatment decision
15887113|NCT03750162|Device|VDW Ultra|supplementary disinfection technique
15887114|NCT03750162|Device|AMD picasso|supplementary disinfection technique
15887115|NCT03750162|Device|ProtaperNext X3 gutta-percha|supplementary disinfection technique
15887116|NCT03750149|Device|EyeTracker|Patients with various ophthalmologic diseases (ERM, glaucoma, AMD, diabetic retinopathy) will undergo reading analysis using the EyeTracker
15887117|NCT03750136|Drug|Hypertonic saline|high dose furosemide with hypertonic saline 3x daily
15887118|NCT03750136|Drug|Furosemide Injection|high dose furosemide
15887119|NCT03750110|Other|Intervention|"In addition to usual care, personalised feedback from the participants screening appointment will be provided;
~For participants with emphysema, an image of their own emphysematous lung compared to a library image of normal lung, or a section of their own non-emphysematous lung. Where emphysema is not present, library pictures showing normal and emphysematous lung will be used.
~For participants with coronary artery calcification, a cross sectional segment from their chest scan (either horizontal or vertical) showing the calcium compared to a library image of coronary arteries without calcification and/or a healthy section of the participant's own heart scan. Where coronary artery calcification is not present, library pictures showing normal and calcified coronary arteries will be provided."
15887120|NCT03750110|Other|Usual Care|Smoking cessation support in line with NICE PH48 guidelines
15887121|NCT03750097|Behavioral|Comfortable walking velocity (CWV)|Walking for 250 Steps with self-selected comfortable walking velocity while wearing the two accelerometers (Polar M600 and ActiGraph wGT3X-BT)
15887122|NCT03750097|Behavioral|Slow walking velocity (SWV: CWV - 20%)|Walking for 250 Steps with slow walking velocity while wearing the two accelerometers (Polar M600 and ActiGraph wGT3X-BT). Slow walking consists of walking with 20% slower than the self-selected comfortable walking velocity by following a researcher who controls the walking velocity with a measuring wheel.
15887123|NCT03750097|Behavioral|Fast walking velocity (FWV: CWV + 20%)|Walking for 250 Steps with fast walking velocity while wearing the two accelerometers (Polar M600 and ActiGraph wGT3X-BT). Fast walking consists of walking with 20% faster than the self-selected comfortable walking velocity by following a researcher who controls the walking velocity with a measuring wheel.
15887124|NCT03750084|Other|questionary|The intervention consists of a digitally distributed questionary.
15887125|NCT03750071|Biological|VXM01|Ty21a transformed with a eukaryotic VEGFR-2 Expression Plasmid
15887126|NCT03750071|Biological|Avelumab|Monoclonal anti-PD-L1 Antibody
15887127|NCT03750058|Device|Implant test procedure|Implant test procedure with new LV quadripolar lead before a standard implantation for Cardiac resynchronisation therapy
15887128|NCT03750045|Diagnostic Test|Jamar|The grip strength was evaluated through a dynamometer JAMAR 5030-J, formed by two parallel steel bars, one stationary and a mobile one, which can be adjusted in five different positions. The volunteer was sitting with a neutrally rotated abducted shoulder, elbow flexed at 90°, the forearm in neutral position, and the wrist between 0° and 30° of extension, 0° to 15° of ulnar variance and it was requested that he or she made the grip movement. This test was performed three times with a one-minute-break between each one.
15887129|NCT03750045|Diagnostic Test|Wooden box|The motor coordination evaluation was made through the measurement of the time spent to perform the task of fitting. To do so, a wooden box was built. In its upper part, there is a circular orifice with 6 cm of diameter.
15887130|NCT03750045|Other|Virtual environment|The system proposed is composed by a virtual environment and an access device. The Leap Motion was used as the access device, making it possible to capture the movements performed by the hands.
15887131|NCT03750032|Procedure|Stapler appendectomy|The patients randomised for this intervention will undergo stapler appendectomy.
15887132|NCT03750032|Procedure|Endoloop|The patients randomised for this intervention will undergo appendicular stump closure using Endoloop.
15887133|NCT03750032|Procedure|Hem-O-Lock|The patients randomised for this intervention will undergo appendicular stump closure using Hem-O-Lock.
15887134|NCT03750019|Behavioral|Satisfying rehearsal task|Participants rehearsed satisfying aspects of the lunchtime meal they just ate.
15887135|NCT03750019|Behavioral|Dissatisfying rehearsal task|Participants rehearsed dissatisfying aspects of the lunchtime meal they just ate.
15887136|NCT03750019|Behavioral|Neutral rehearsal|Participants rehearsed their journey to campus that day.
15887244|NCT03749148|Drug|Placebo|Placebo
15887139|NCT03749967|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|MagVenture MagPro TMS System would be utilized to deliver 3-minute sessions of intermittent theta burst to left dorsolateral prefrontal cortex.
15887140|NCT03749954|Diagnostic Test|Detachable string magnetically controlled capsule endoscopy|Esophagogastroduodenoscopy is performed 2 hours after the magnetically controlled capsule endoscopy (Ankon Medical Technologies Co. Ltd.).
15887141|NCT03749928|Device|OstiSense biosensor - active|The activated biofeedback back night guard will be used to reduce sleep bruxism
15887142|NCT03749928|Device|OstiSensor biosensor - not activated|A not-activated night guard will be used as control device
15887143|NCT03749915|Device|Pain Ease Cold Spray|Pain Ease is a spray containing 1,1,1,3,3-Pentafluoropropane (HFC-245fa) and 1,1,1,2-Tetrafluoroethane (HFC-134a). It is a vapocoolant for use as a topical anesthetic.
15887144|NCT03749915|Drug|Ametop|Tetracaine Hydrochloride Gel 4%
15887145|NCT03749902|Drug|Oral misoprostol|"An initial dose of misoprostol 25mcg will be given orally after randomisation (this must be a minimum of 2 hours after the previous misoprostol dose).
~The next dose of oral misoprostol will be omitted if moderate or strong contractions are occurring at 3 in 10 minutes or more (i.e. 9 or more in the preceding 30 minutes)
~If contractions subsequently reduce to less than 3 in 10 (under 9 in 30 minutes), or become irregular or mild, then the oral misoprostol 25mcg can be restarted
~In the event of inadequate progress, clinicians will be advised to give further misoprostol if there are any concerns about contractions strength or frequency."
15887146|NCT03749902|Drug|Oxytocin|"Oxytocin infusion will be given through an electronic infusion pump. One unit of oxytocin will be injected in 500 mL of Ringer's lactate, started at a rate of 2 mU/min, and increased every 30 min by 2 mU/min until there are three to four contractions every 10 min. The rate will be titrated to maintain that contraction frequency. The maximum dose will be 20mU/min as oxytocin summary product characteristics.
~The oxytocin group will not receive misoprostol after the membranes have ruptured."
15887147|NCT03749889|Other|100 g carbs|Participants will be assigned a diet of 100g carbs max for the day
15887148|NCT03749889|Other|MyPlate|40-65% of daily intake is from carbohydrates
15887149|NCT03749876|Other|Unfiltered Cigarettes|Participants will be given unfiltered Pall Mall or Camel cigarettes to smoke for two weeks according to the brand they smoked prior to the start of the study. They will agree to smoke the cigarettes using a monitoring device (CReSS) that measures puffing behavior on five (5) days during each of the two weeks. They will also collect their cigarette butts on all days as a measure of smoking behaviors.
15887150|NCT03749876|Other|Filtered Cigarettes|Participants will be given filtered Pall Mall or Camel cigarettes to smoke for two weeks according to the brand they smoked prior to the start of the study. They will agree to smoke the cigarettes using a monitoring device (CReSS) that measures puffing behavior on five (5) days during each of the two weeks. They will also collect their cigarette butts on all days as a measure of smoking behaviors.
15887151|NCT03749863|Procedure|Serial PRP injections|Autologous platelet-rich plasma will be injected into the vocal fold mucosa in a serial fashion, once per month for a total of 4 injections.
15887152|NCT03749850|Drug|LTLD|"Patients will receive up to six cycles at three-weeks intervals of:
~Intravenous LTLD dosed at 50mg/m2 administered during the MR-HIFU treatment
~60 minutes of MR-HIFU mild local hyperthermia at 40 °C - 42 °C to the primary breast tumour
~Intravenous Cyclophosphamide 600 mg/m2 after MR-HIFU treatment
~In case of toxicity, LTLD, cyclophosphamide and/or hyperthermia dosages will be adjusted as specified in the study protocol."
15887153|NCT03749850|Procedure|MR-HIFU induced hyperthermia|"Patients will receive up to six cycles at three-weeks intervals of:
~- 60 minutes of MR-HIFU mild local hyperthermia at 40 °C - 42 °C to the primary breast tumour.
~In case of toxicity, hyperthermia dosages will be adjusted as specified in the study protocol."
15887154|NCT03749850|Drug|Cyclophosphamide|"Patients will receive up to six cycles at three-weeks intervals of:
~- Intravenous Cyclophosphamide 600 mg/m2 after MR-HIFU treatment
~In case of toxicity, cyclophosphamide dosages will be adjusted as specified in the study protocol."
15887155|NCT03749837|Device|C- MAC VS|The C-MAC VS is a new device on the airway management aid market. It will be used according to the instructions of the distributor. Before the study starts on humans, each study participants will do at least 5 intubations on an airway manikin or more until he or she feels confident to use the device.
15887156|NCT03749837|Device|Video Endoscope|Fiberoptic video endoscopic devices are standard aids to facilitate intubation on all study sites and are used according to the instructions to use. To facilitate fiberoptic intubation a macintosh blade to raise the root of tongue will be used. Also with these devices the study participants need at least 5 trials to intubate a manikin (or more to feel confident) before they are going to use the study device in patients.
15887157|NCT03749824|Dietary Supplement|Omega-3|Omega-3 supplement is a highly concentrated fish oil brain booster supplement that helps compensate for the neurocognitive and brain dysfunction which acts as a predisposition to antisocial and violent behaviour. Individuals with antisocial personality disorder have been found to show an 11% reduction in gray matter in the prefrontal cortex (Raine et al. 2001), and structural prefrontal impairments are hypothesised to result in disinhibition of limbic subcortical structures that give rise to aggressive behaviour. Omega-3 (specifically DHA) is known to play a key role in neuronal structure and function.
15887158|NCT03749824|Dietary Supplement|Placebo Capsules|Children in this group will be given two placebo capsules twice daily; at breakfast and at the evening meal for a total period of 6 months.
15887159|NCT03749811|Device|Pupillometry|After induction of anesthesia and determination of the loss of consciousness of the participant, baseline diameter of pupil is measured by electronic pupillometry device. During anesthesia, participant's pupil diameter is repeatedly measured with 5-minute interval. Pupil dilation of 30% or more compared to baseline is indicative of insufficient analgesia.
15887160|NCT03749798|Procedure|Cataract surgery|Intraoperative wavefront measurements will be carried out during cataract surgery
15887161|NCT03749785|Other|Regular carbohydrate feeding|60 ml of water with 5 g sucrose given every 5 minutes 14 times up until 70 minutes followed by 5 g sucrose after 75 minutes in a 250 ml solution
15887162|NCT03749785|Other|Single carbohydrate bolus|60 ml of water given every 5 minutes 14 times up until 70 minutes followed by 75 g sucrose after 75 minutes in a 250 ml solution
15887245|NCT03749135|Drug|Dupilumab|anti-IL4-Receptor alpha
15887246|NCT03749135|Drug|Placebo|Placebo
15887247|NCT03749122|Procedure|Waiting time for hip fracture surgery|Time from hospital admission to start of hip fracture surgery
15887163|NCT03749772|Behavioral|Cognitive Training|The intervention was carried out with the PC game Brain Exercise TM (Bandai Namco Games Ltd.). Participants held the training sessions on an HP 250 G3 Notebook PC (Windows 10), with a 15-inch screen, and a resolution of 1366x768x40 Hz. The performance achieved by each participant in each session was recorded to analyze the evolution of the subjects. The participants made a total of 12 practice exercises, which implies approximately 30 minutes of duration per session.
15887164|NCT03749759|Procedure|Cataract surgery|A biofeedback measurement will be carried out during cataract surgery of both eyes
15887165|NCT03749746|Behavioral|Home Blood Pressure Monitoring|Each participant will receive 1:1 training by the project staff in all aspects of home blood pressure monitoring (HBPM). Throughout the study, they will be asked to monitor home blood pressures for the first week of each month with Bluetooth-enabled blood pressure cuffs.
15887166|NCT03749746|Behavioral|Heart Health 4 New Moms|The intervention is comprised of four key components: (1) The online curriculum consists of 12 modules on healthy eating and physical activity adapted from the Diabetes Prevention Program and specifically targeting postpartum women. (2) Self-monitoring and tracking program, in which participants will be provided with a Bluetooth-enabled blood pressure cuff and digital scale and will be provided real-time feedback on their blood pressure and weight trends. (3) A registered dietitian will act as a lifestyle coach for participants with regular review of progress and provision of coaching notes, support and suggestions. (4) Finally participants will have access to a customized online toolbox, including dietary tracking sheets and recipes from the American Heart Association (AHA).
15887167|NCT03749746|Other|Usual care|Participants will be counseled on routine postpartum care and will receive additional information on cardiovascular risk following preeclampsia as well as information on support groups and registries as well as online resources for lifestyle modification.
15887168|NCT03749733|Drug|Estradiol 1.5 mg/nomegestrol acetate 2.5 mg (Reference Product)|Marketed Drug
15887169|NCT03749733|Drug|Estradiol 1.5 mg/nomegestrol acetate 2.5 mg (Test Product)|Investigational Medicinal Product
15887170|NCT03749720|Other|Blood sample|Blood sample taken from cervical cancer patients at time of diagnosis (baseline) and follow-up visits.
15887171|NCT03749707|Diagnostic Test|HPV analysis|HPV analysis of SLNs
15887172|NCT03749668|Other|non applicable|no intervention in this observational study
15887173|NCT03749655|Behavioral|Physical Activity Promotion|The physical activity (PA) promotion intervention will be provided only to the intervention group, and will include: 1) a step-counter with a digital display, 2) an interview discussing motivational issues, favourite daily activities and strategies to become more physically active; and 3) a tailored physical activity coaching plan including an Individualised activity goal (in steps/day) revised twice weekly through consultation sessions (16 sessions in total). Patients' targets will be revised twice weekly during the consultation sessions which will be incorporated into the Pulmonary rehabilitation sessions. The aim is to increase physical activity by 10% each week. The goal can be altered if required.
15887174|NCT03749642|Drug|trazodone/gabapentin 2.5/25 mg|The total daily doses administered will be trazodone 7,5 mg and gabapentin 75 mg.
15887175|NCT03749642|Drug|trazodone/gabapentin 5/50 mg|The total daily doses administered will be trazodone 15 mg and gabapentin 150 mg.
15887176|NCT03749642|Drug|trazodone/gabapentin 10/100|The total daily doses administered will be trazodone 30 mg and gabapentin 300 mg.
15887177|NCT03749642|Drug|Gabapentin|"The total daily doses administered will be:
~600 mg from day 0 to day 6 (±1)
~900 mg from day 7 (±1) to day 13 (±1)
~1200 mg from day 14 (±1) to day 20 (±1)
~1800 mg from day 21 (±1) to day 56 (±2)"
15887178|NCT03749642|Drug|Placebo oral capsule|Two capsules, three times a day, for 8 weeks.
15887179|NCT03749629|Other|GeneSight Psychotropic test|GeneSight® Psychotropic powered by CPGx® technology, the only test for depression reimbursable by Medicaid and Medicare. GeneSight® is a neuropsychiatric, combinatorial, PGx test that provides recommendations for psychotropic medications (antidepressants, mood stabilizers, hypnotics for insomnia, and antipsychotics) based on a patient's individual genetic profile.
15887180|NCT03749629|Other|Canadian Network for Mood and Anxiety Treatment (CANMAT) Best Practice Guidelines|Guidelines for treatment
15887181|NCT03749616|Drug|Ibuprofen|NSAID Group - will be administered ibuprofen 400-800 mg, up to three times a day as needed for pain control
15887182|NCT03749616|Drug|Acetaminophen|Control Group - will be administered acetaminophen for pain control with dose and frequency of 325mg 1-2 tablets q4-6h hours as needed, Maximum dose 1000mg. Maximum amount per day: 3g/day.
15887183|NCT03749603|Device|TIBAY Meter|fluorescence probe will be applied for 3-5 minutes onto the wet vermillion of the lower lip.
15887184|NCT03749590|Drug|Magnesium Sulfate|Patients receive 2 infusions (10 ml magnesium sulfate added to 500 ml NaCl 0.9%): the first infusion 60 min before and the second one 6 hours after ERCP
15887185|NCT03749590|Drug|Placebo (NaCl 0,9%)|Patients receive 2 infusions (10 ml NaCl 0.9% added to 500 ml NaCl 0.9%): the first infusion 60 min before and the second one 6 hours after ERCP
15887186|NCT03749577|Dietary Supplement|L-citrulline|L-citrulline 9g per day (capsule, per os) during 14 days;
15887187|NCT03749577|Dietary Supplement|Beetroot juice|Concentrated 70 ml beetroot juice bottles containing 6.45 mmol of nitrates
15887188|NCT03749577|Dietary Supplement|L-citrulline placebo|L-citrulline placebo (maltodextrin) 9g per day (capsule, per os) during 14 days
15887189|NCT03749577|Dietary Supplement|Denitrated beetroot juice|Concentrated 70 ml nitrate-depleted beetroot juice
15887190|NCT03749564|Behavioral|SMT|"The subject is supine. The clinician stands opposite the side to be manipulated and side-bends the subject away from the side to manipulate. The side to be manipulated is the more painful. If the subject cannot identify a more painful side the clinician selects a side. The clinician rotates the subject, and delivers a high-velocity, low-amplitude (HVLA) thrust to the pelvis in a posterior/inferior direction. The clinician notes if a cavitation (ie, a pop) occurred. If it does, SMT treatment is complete. If no cavitation occurs, the subject is repositioned and SMT is performed again. If no cavitation occurs on the second attempt, the clinician manipulates the opposite side. A maximum of 2 attempts per side is permitted. If no cavitation is noted by that time, SMT treatment is complete. Substitution with a side-posture HVLA technique is allowed if the preferred technique is not possible due to subject preference or comfort."
15887248|NCT03749109|Drug|Quinagolide 1080 µg|Vaginal ring containing Quinagolide 1080 µg for daily releases
15887249|NCT03749109|Drug|Placebo|Matching placebo
15887191|NCT03749564|Behavioral|Activation Exercises|Activation exercises are designed to facilitate use of the lumbar multifidus muscle. Exercises will begin with isometric multifidus contractions in different positions with clinician feedback and exercises to isometrically co-contract the multifidus and deep abdominal muscles. Subjects will also perform lumbar extensor strengthening exercises shown to produce 20%-50% of multifidus maximum voluntary contraction. Subjects will continue to perform isometric exercises throughout treatment. Subjects will perform their prescribed exercises at treatment sessions and will be instructed to perform the exercises daily on other days.
15887192|NCT03749564|Behavioral|Mobilizing Exercises|Mobilizing exercises include a program of repeated movements progressing into end-ranges of spinal flexion and/or extension shown in past studies to improve ROM and reduce spinal stiffness. Patients will be instructed in mid-range exercises and will be further assessed for a directional preference. A directional preference is present if movement in a particular direction decreases LBP intensity or causes symptoms to centralize towards the midline. If a subject has a directional preference he or she will be prescribed exercises specifically in that direction along with mid-range exercise. Otherwise the subject will be assigned exercises moving into either flexion or extension based on the clinician's discretion. Subjects will perform their prescribed exercises at treatment sessions and will be instructed to perform the exercises daily on other days.
15887193|NCT03749564|Behavioral|Extended SMT|Additional 6 SMT sessions provided
15887194|NCT03749551|Diagnostic Test|cardiac magnetic resonance (CMR) post haemodialysis|patients will undergo a second CMR scan immediately after receiving haemodialysis (native CMR study)
15887195|NCT03749538|Other|Transcranial direct current stimulation session.|Patients with systemic autoimmune myopathies will receive or not acute transcranial direct current stimulation session.
15887196|NCT03749525|Drug|shenfu injection|we hypothesis that shenfu injection could improve patients' arterial vascular reactivity with septic shock
15887197|NCT03749512|Diagnostic Test|Complete blood count|During routine preoperative blood test complete blood count is taken.
15887198|NCT03749512|Other|Histopathological examination|Routine postoperative histopathological examination of lung tumor.
15887199|NCT03749499|Other|HTN Educational Video|The video will educate participants in arm 2 about high BP, how it is diagnosed, and the importance of treating it to prevent secondary complications.
15887200|NCT03749499|Other|Visual Echocardiogram Image Clips|Visual clips of age/gender-matched echocardiograms will be used to educate and motivate patients to change their behavior and improve their BP. We have found that real time visualization of cardiac ultrasound images with active discussion of findings is a significant patient motivator and empowerment tool, and was a significant factor in the success of our previous pilot study.
15887201|NCT03749499|Other|Mobile Health and Remote BP monitoring|All participants randomized to the intervention group will receive an FDA-approved HBPM kit that includes the Nokia wireless (self-inflating) BPM+ monitor and Health Mate mobile app. The app automatically launches when the patient slips on the cuff and turns on the monitor to measure his/her BP. Synced data are automatically uploaded from the mobile app to the iCardia server of our study.
15887202|NCT03749499|Other|Post-Acute Care HTN Transition consultation (PACHT-c)|All participants randomized to the E2 intervention will have a focused consultation with either a clinical pharmacist or an APN. During this consultation, the pharmacist/APN repeats the BP measurement; reviews the screening assessments; and reviews general principles of BP control including nutrition, exercise, and smoking cessation. BP will be managed according to the current published guidelines available at the time of funding regarding initiation of first-line antihypertensive medications. Patients with BP ≥160/100 mmHg may be started on antihypertensive medications by the provider during the consultation if appropriate.
15887203|NCT03749486|Procedure|Cataract surgery|Cataract surgery will be done following ArcScan measurement
15887204|NCT03749473|Behavioral|Choice + Immediate|Participants in the choice + immediate goal arm will choose a step goal and must attempt to achieve this new step goal immediately at the start of the study.
15887205|NCT03749473|Behavioral|Choice + Gradual|Participants in the choice + gradual goal arm will choose a step goal and will gradually work towards the chosen step goal over the first 8-weeks of the study.
15887206|NCT03749473|Behavioral|Assigned + Immediate|Participants in the assigned + immediate goal arm will be assigned a step goal and must attempt to achieve this new step goal immediately at the start of the study.
15887207|NCT03749473|Behavioral|Assigned + Gradual|Participants in the assigned + gradual goal arm will be assigned a step goal and will gradually work towards the chosen step goal over the first 8-weeks of the study.
15887208|NCT03749473|Behavioral|Daily performance feedback|Participants will receive daily performance feedback on their daily step count.
15887209|NCT03749473|Behavioral|Gamification|All participants in the intervention arms will be entered into a gamification platform that has points and levels designed to incorporate insights from behavioral economics.
15887210|NCT03749460|Biological|Nivolumab|Given IV
15887211|NCT03749460|Biological|Ipilimumab|Given IV
15887212|NCT03749460|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15887213|NCT03749447|Drug|Bardoxolone methyl|Bardoxolone methyl capsules
15887214|NCT03749421|Other|Prosigna PAM-50 assay|Looks at the gene activity of a person's cancer cells to determine the likely outcome or course of a disease (prognosis) and predict the benefit of chemotherapy or endocrine therapy after breast surgery
15887215|NCT03749408|Drug|bupivacaine plus mannitol|local anesthesia
15887216|NCT03749408|Drug|bupivacaine alone|local anesthesia
15887217|NCT03749395|Procedure|Erector Spinae Plane Block|The patient will be placed in a sitting position and the ultrasound probe will be placed in a longitudinal orientation 3 cm lateral to the T5 spinous process. Three muscles were identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae . the needle will be inserted in a cephalad-to-caudad direction until the tip lay deep to erector spinae muscles, as evidenced by visible linear spread of fluid beneath muscle upon injection . A total of 20 mL of 0.25% bupivacaine will be injected here.
15887250|NCT03749096|Drug|Intravenous Immunoglobulins, Human|Immunoglobulins are fractionated blood products made from pooled human plasma.
15887251|NCT03749096|Drug|Placebos|Normal Saline
15887252|NCT03749083|Other|The Functional Assessment of Cancer Therapy- Colorectal|The Functional Assessment of Cancer Therapy- Colorectal (FACT-C) questionnaire measures health-related quality of life for people with chronic illnesses.
15887218|NCT03749382|Other|AprilAge- facial morphing appearance based intervention for smoking|"Appearance-based intervention: The intervention is a software that ages an individual's face with and without the effects of smoking. Participants have their photo taken on a laptop webcam, they are then asked to report their age and ethnicity in order to calibrate the software, the participants picture is then matched to a stock image. The participants will see two images on the screen, on the left is there face aged without the effects of smoking and one the right aged with the effects of smoking. Participants will be led through a series of morphing sequences (1-5). In-between each of the morphing sequences (Morph1 to Morph5) the participant will be asked to comment on the differences they can see between the two images.
~General stop smoking intervention: The General stop smoking intervention comes in the form of a NHS stop smoking information leaflet. The participants will be given the leaflet on a laptop screen and asked to read through the whole document."
15887219|NCT03749369|Drug|Salvadora Persica Root|Salvadora Persica Gel
15887220|NCT03749369|Procedure|Scaling and root planing|Thorough scaling and root planing (SRP) will be performed by a single clinician. The SRP procedure will be carried out in two sittings, comprising of ultrasonic scaling in the first, and manual instrumentation and root debridement in the second.
15887221|NCT03749356|Drug|TacroBell SR cap.|"Orally, once-daily in the morning
~After first dose 0.2mg/kg, check the blood concentration of tacrolimus at each visit and adjust the dose to acheive the blood concentration maintaining at 3~12ng/ml for 0 to 3months and then at 3~8ng/ml for 3 to 6months of study treatment."
15887222|NCT03749330|Behavioral|CICU Team And Loved Ones Communicating (CICU TALC)|When the necessary pre-intervention clinical encounters are completed, clinicians will go through the interprofessional team training to improve communication skills and teamwork in developing care plans and communicating with families in family meetings. The first step in the study is co-design of the intervention, so it will evolve as the study continues.
15887223|NCT03749317|Drug|IVIEW-1201|IVIEW-1201; QID; one drop per eye, four times per day (QID) for 7 days
15887224|NCT03749317|Drug|Placebo|Placebo drug; QID; one drop per eye, four times per day (QID) for 7 days
15887225|NCT03749304|Device|ANI monitor|experimental medical device using expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index
15887226|NCT03749291|Other|Obemat2.0 therapy|"Lifestyle (diet & physical activity) structured recommendations through a motivational interview.
~Duration: 12(+3) months Description: 1 visit/month & 3 Workshops in primary care centers Providers: pediatricians and nurses trained to perform motivational interview The interviews are structured as follows: First, checking the accomplishment of objectives to motivate the participant. Second, a specific topic per visit is explained to the participant. Third, a task related to the topic (i.e. to plan a weekly menu for the family) is given to be brought back at the next visit. 4th. Objectives about diet, weight & physical activity are defined to be accomplished until the next visit."
15887227|NCT03749291|Other|Usual Clinical Practice|Lifestyle (diet and physical activity) Duration: 12 (+3) months Description: 1visit/month to the primary care centers. Providers: pediatricians & nurses. Children assigned to the control group receive the usual treatment conducted in primary care centers based on the Clinical Practice Guidelines on the Prevention and Treatment of Child and Adolescent Obesity [Spanish Ministry of Science and Innovation], 2009). At visits, the family receive recommendations to carry out a balanced diet, to provide a moderate energy reduction from the previous intake. An increase in physical activity, both in terms of leisure activity, as sports is advised.
15887228|NCT03749278|Behavioral|Latina Friends Motivating the Soul (ALMA)|In a series of 8 weekly sessions, the program uses a group format to teach and encourage women to use coping strategies to reduce depression and anxiety. Over the course of the eight ALMA sessions, 25 women are (1) engaged in activities to identify coping strategies they are currently using and encouraged to continue to use them; (2) introduced to new coping strategies (e.g. mindfulness techniques, increased social ties and social support); and, (3) provided resources for seeking additional help if needed
15887229|NCT03749265|Other|Ultrasound test|patients need to undergo an ultrasound test for detecting the presence or abscence of peroneus tertius tendon
15887230|NCT03749252|Drug|P03277|A dose of 0.05 mmol/kg body weight (0.1 mL/kg body weight) of P03277 will be administered to each patient in a single intravenous injection.
15887231|NCT03749239|Dietary Supplement|Collagen protein|Collagen protein
15887232|NCT03749226|Drug|Aztreonam lysine|nebulization
15887233|NCT03749226|Device|Aerogen Solo|Aerogen's vibrating mesh technology, available within the Aerogen® Solo has been adopted for use of conventional mechanical ventilation. Aerogen Solo utilizes active vibrating mesh technology, where energy applied to the vibrational element, causes vibration of each of the 1000 funnel shaped apertures within the mesh. The mesh acts as a micropump drawing liquid through the holes producing a low velocity aerosol optimized for targeted drug delivery to the lungs. According our study (Rodriguez A et al , Expert Opin Drug Deliv. 2017 Dec;14(12):1447-1453) Aeroneb Solo showed an excellent aerosol delivery profile for Aztreonam lysine (AZLI) in an in vitro model of MV with short drug delivery time.
15887234|NCT03749226|Device|CombiHaler|The inhalation chamber CombiHaler™ spacer for mechanical ventilation and critical care (ICU) allows using both a vibrating mesh nebulizer such as Aeroneb ™, and a pMDI. It saves 50% of the nebulized drug when used in invasive ventilation. The inhalation chamber CombiHaler® is integrated on a circuit of a breathing device in invasive ventilation in particular for connexion of an Aeroneb® Pro or an Aeroneb® Solo. According our study (Rodriguez A et al , Expert Opin Drug Deliv. 2017 Dec;14(12):1447-1453) a better aerosol delivery performance (30%) was obtained using the Conbihaler spacer.
15887235|NCT03749213|Drug|Icotinib|Patients with EGFR-mutant Stage ⅢA-N2 Non-small Cell Lung Cancer which can be potentially radical treated by surgery are arranged to receive Icotinib with a dose of 125 mg three times per day orally for 8 weeks as neoadjuvant therapy before surgery and for 2 years as adjuvant therapy or till progressive disease or unaccepted toxicity.
15887236|NCT03749200|Other|Obemat2.0 therapy|
15887237|NCT03749200|Other|Regular practise in primary care|
15887238|NCT03749187|Drug|PARP Inhibitor BGB-290|Given PO
15887239|NCT03749187|Drug|Temozolomide|Given PO
15887240|NCT03749174|Procedure|Long acting Supraclivicular block vs Short acting Supraclavicular block|"Patients are randomized to receive; long-acting Supraclavicular plexus block or short-acting Supraclavicular plexus block or general anesthesia
~Sub group randomized to plaster/cast or orthosis/brace, both having short-acting block"
15887241|NCT03749161|Device|Low-add multifocal IOL|Lentis comfort, low-add multifocal, IOL
15887253|NCT03749070|Dietary Supplement|Silymarin|It is a randomized, double-blind, controlled clinical trial to be performed at outpatient level. The intervention will last 12 weeks and the invited participants will be patients attended at the outpatient clinic of the Edgard Santos Hospital, which will be randomized into two groups: control and intervention. Data on laboratory and clinical markers, imaging, nutritional and dietary assessment will be collected at the beginning and end of the trial for comparison purposes.
15887254|NCT03749057|Drug|Rivaroxaban|Rivaroxaban 15-20 mg daily
15887255|NCT03749044|Other|Patient Educational Tool|This tool is a modified version of the patient educational sheet elaborated and validated by You et al in collaboration with the Preeclampsia Foundation. This patient educational sheet graphically defines preeclampsia and its. A licensing agreement has been obtained from the Preeclampsia Foundation, with the rights to modify the educational tool for this RCT. The SLE-specific educational tool will consist in a sheet displaying the previously developed patient educational form on the recto. However, on the verso of the sheet, SLE-specific information related to the risk of preeclampsia in SLE pregnancies and the estimated efficacy of ASA in reducing preeclampsia risk in women at high risk are displayed.
15887256|NCT03749031|Other|Orange juice + Orange Pomace|16 oz. orange juice + orange Pomace per day for 4 weeks
15887257|NCT03749031|Other|Orange Juice|16 oz. orange juice per day for 4 weeks
15887258|NCT03749031|Other|Apple Juice and Apple Pomace|16 oz. apple juice and apple Pomace per day for 4 weeks
15887259|NCT03749031|Other|Apple Juice|16 oz. apple juice per day for 4 weeks
15887260|NCT03749018|Drug|Cyclophosphamide|Given IV
15887261|NCT03749018|Drug|Doxorubicin Hydrochloride|Given IV
15887262|NCT03749018|Drug|Etoposide|Given IV
15887263|NCT03749018|Biological|Nivolumab|Given IV
15887264|NCT03749018|Drug|Prednisone|Given PO
15887265|NCT03749018|Biological|Rituximab|Given IV
15887266|NCT03749018|Drug|Vincristine Sulfate|Give IV
15887267|NCT03748992|Drug|gNO|"This is a proof-of-concept study in which all subjects will be treated with gNO (i.e. no control) to see if there can be a microbiological effect by conversion to negative sputum cultures and how long that effect can be sustained following treatment.
~Participants will be treated for 3 weeks (5 days per week), Monday through Friday, and followed monthly for 3 months.
~The treatment period includes a physical exam, vital signs, blood tests, echocardiogram, spirometry test, sputum sample, questionnaires, and the inhalation gas treatment. During the inhalation gas treatment, participants will wear a face mask (similar to an oxygen mask) and will be given nitric oxide gas through the participants nose for three treatments with fifty minutes each time. They will then be followed up monthly during the Follow-up period with tests that include a physical exam and questionnaires."
15887268|NCT03748979|Drug|TAK-925|TAK-925
15887269|NCT03748979|Drug|Placebo|TAK-925 Placebo
15887270|NCT03748966|Drug|Calcitriol|Adults and children (age 6-17) with X-linked hypophosphatemia will be treated with calcitriol therapy without phosphate supplementation. Doses of calcitriol will be escalated and optimized in the first three months of the study. Calcitriol is an oral medication taken once a day.
15887271|NCT03748953|Drug|Ixazomib|Ixazomib Capsules
15887272|NCT03748940|Drug|LY3074828|Administered SC
15887273|NCT03748940|Drug|Placebo|Administered SC
15887274|NCT03748940|Drug|LY900021|Administered SC
15887275|NCT03748914|Other|Intervention Group|After delivery of the neonate via caesarean section the umbilical cord will be clamped within 30 seconds and cut long at least 30 cm by the obstetrician. The neonate is then placed under an overhead heater by the midwife. There, the umbilical cord must be untwisted and held in a vertical position. It is milked once by the neonatologist towards the baby at a speed of approximately 10 cm/s and then clamped 3 cm from the umbilicus by one member of the clinical team.
15887276|NCT03748914|Other|Control Group|The umbilical cord is cut according to the standard procedure and no C-UCM is performed.
15887277|NCT03748888|Behavioral|Exercise group|"An antenatal physical activity (APA) programme will be designed for participants in the exercise group.
~The APA will last for 20-24 weeks. Participants in the EG must enrol in the APA between their 12-16 weeks of gestation.
~The APA programme has a frequency of three times a week, which involves aerobic, strength and stretching exercises. The intensity of the APA programme is individually calculated for each participant based on their pre-pregnancy fitness level. Single sessions of the APA programme last 50-60min."
15887278|NCT03748875|Behavioral|mindfulness-based relapse prevention|mindfulness-based relapse prevention, 8 weeks
15887279|NCT03748862|Other|Taper Plan|Occurrence of a taper plan defined by a primary care provider during the follow-up period. Evidence of a taper plan will be obtained by searching prescriptions (SIGs) and medical encounter notes using natural language processing (NLP).
15887280|NCT03748849|Procedure|Physiotherapy|
15887281|NCT03748836|Drug|ALPN-101|Single or multiple doses of ALPN-101 delivered via intravenous or subcutaneous injection. Ascending dose levels will be evaluated.
15887282|NCT03748836|Drug|Placebo|Single or multiple doses of placebo delivered via intravenous or subcutaneous injection, matched to ALPN-101 cohorts.
15887283|NCT03748810|Drug|Empagliflozin|Empagliflozin 25 mg once daily add on the background OADs for 3 years
15887284|NCT03748810|Drug|Dapagliflozin|Dapagliflozin 25 mg once daily add on the background OADs for 3 years
15887285|NCT03748797|Other|Moderate intensity exercise training under supervision|Upper and lower limbs cycling, treadmill walking, multi-gym strengthening, stepper exercise, dumb bell and squatting exercise
15887286|NCT03748784|Biological|ADVM-022|ADVM-022 (AAV.7m8-aflibercept) is a recombinant, replication-deficient adeno-associated virus (AAV.7m8) gene therapy vector carrying a coding sequence for aflibercept
15887287|NCT03748758|Combination Product|Drug: OP0201|Drug OP0201
15887288|NCT03748758|Combination Product|Drug: Placebo|Placebo
15887289|NCT03748745|Drug|SH229|tablet, oral, 600 mg once daily for day 1 to day 14
15887290|NCT03748745|Drug|SH229|tablet, oral, 600 mg once daily for day 8 to day 14
15887291|NCT03748745|Drug|Daclatasvir dihydrochloride|tablet, oral, 60 mg once daily for day 8 to day 14
15887292|NCT03748745|Drug|Daclatasvir dihydrochloride|tablet, oral, 60 mg once daily for day 1 to day 14
15887293|NCT03748732|Procedure|sclerectomy|scleral flap
15887294|NCT03748719|Device|Stereotactic Body Radiation Therapy (SBRT)|SBRT treatment
15898405|NCT03662100|Biological|LY3074828|Administered SC
15887296|NCT03748693|Procedure|Hysterectomy|Surgery performed on women with a variety of gynecological indications
15887297|NCT03748693|Procedure|Colporrhaphy|Surgery performed on women with POP
15887298|NCT03748680|Drug|Capox (or FOLFOX) including flouropyrimidine and oxaliplatin combination chemotherapy|"Six months of adjuvant combination chemotherapy with Capox (or FOLFOX) Patients will receive adjuvant chemotherapy with eight cycles of CAPOX (oxaliplatin 130 mg/m2 day 1 and capecitabine 1000 mg/m2 b.i.d. days 1-14, repeated every 3 weeks.
~(Patients with an ileostomy are only eligible for FOLFOX and will be treated with 12 cycles of FOLFOX (oxaliplatin 85 mg/m2 day 1, leucovorin 400 mg/m2 day 1, 5FU 400 mg/m2 bolus day 1 and 5FU 2400 mg/ m2 over 46-48 hours day 1-3, repeated every second weeks)"
15887299|NCT03748680|Other|Intensified Follow-up Schedule|Close monitoring with Imaging during follow-up Patients included in this trial will undergo intensified follow-up with CT-chest and abdomen every four months after surgery for the first 2 years, then every 6 months for 1 years and finally once yearly for the last 2 years up to 5 years follow-up is completed.
15887300|NCT03748667|Diagnostic Test|White light endoscopy (WLE)|Subjective endoscopic assessment of deep submucosal invasion based on the presence of gross morphological malignant features, morphology and size.
15887301|NCT03748667|Diagnostic Test|NBI/BLI +/- chromoendoscopy (NBIBLI +/- CE)|Endoscopic assessment of deep submucosal invasion with NBI and dual focus/magnification or BLI and magnification. In the case of demarcated areas or JNET 2B, Kudo pit pattern assessment with crystal violet will be performed.
15887302|NCT03748654|Diagnostic Test|Visual Field Testing|Visual field test using the protocol 24-2 Threshold Test
15887303|NCT03748641|Drug|Niraparib|Participants will receive niraparib 200 mg capsules once daily.
15887304|NCT03748641|Drug|Abiraterone Acetate|Participants will receive AA 1000 mg tablets once daily.
15887305|NCT03748641|Drug|Prednisone|Participants will receive prednisone 10 mg tablets daily.
15887306|NCT03748641|Drug|Placebo|Participants will receive matching placebo once daily.
15887307|NCT03748641|Drug|New Formulation of Niraparib and Abiraterone Acetate (AA)|Participants will receive a new formulation of niraparib 200 mg and AA 1000 mg tablets once daily.
15887308|NCT03748628|Drug|EDP-305|[14C]EDP-305
15887309|NCT03748615|Device|Computer Guided ridge splitting in posterior mandible|"The computer guided ridge splitting for patients with atrophic posterior mandible and with residual bone width at least 3 to 5mm of residual ridge.
~The selected patients will be informed of the nature of the research work and informed consent will be signed.
~Radiographic examination included preoperative digital panoramic radiograph with 1:1 magnification for each patient as a primary survey to obtain an approximation of the available bone height and detect the presence of remaining roots and localized pathosis.
~Computer surgical guides are fabricated for partially edentulous patients using teeth and tissue as support for the guide.
~The same surgeon performed all surgeries. All surgical procedures were performed under strict aseptic conditions, all patients received nerve block local anesthesia (Articaine 4% 1:100 000 epinephrine).
~A crestal incision is made using No. 15 blade extending over the posterior mandible using computer guided surgical stent.
~no flap elevation ."
15887310|NCT03748602|Procedure|Thoracic outlet decompression|TOD consists out of first rib resection with partial scalenectomy and neurolysis. If there are also complaints below the pectoral minor tendon insertion, a pectoral minor tenotomy is performed.
15887311|NCT03748589|Device|laryngeal mask airway|i-gel laryngeal mask airway is a supraglottic airway device made from a medical grade thermoplastic elastomer , is a non-inflatable device to create anatomical seal of the pharyngeal, laryngeal and perilaryngeal structures and avoid compression trauma.
15887312|NCT03748576|Behavioral|telemedicine: management through WeChat group chat|Patients in intervention group received additional WeChat group management when conducted standard clinic prenatal care
15887313|NCT03748563|Diagnostic Test|ds-MCE and EGD|"Procedure of ds-MCE:
~The ds-MCE system mainly consists of two parts: the NaviCam magnetic capsule endoscopy guidance system and the detachable string part. The capsule, which is partially enclosed within the sleeve, can be actively moved in the esophagus through the control of string. Investigator can examine the entire esophagus several times under real time views. The capsule then could be detached from the string system through injecting air into the hollow string with the syringe after completing the examination of esophagus. Then, the examination of stomach under magnetic control and small bowel under the natural action of peristalsis follows.
~Procedure of EGD:
~The EGD will be performed using conventional upper gastrointestinal video endoscopy, according to the standard procedure at individual centers. EGD will be performed within 48 hours after ds-MCE procedure and usually during the same endoscopic session."
15887314|NCT03748550|Behavioral|Aerobic exercise|All participants will receive standard of care for their cancer as well as given a 12-week, home-based progressive aerobic exercise (AE) program. A nonlinear progressive training approach will be used whereby each participant will perform two AE sessions (e.g. walking), on non-consecutive days, per week. AE sessions will vary between low (35-45% heart rate reserve (HRR)), low-moderate (46-55% HRR), high-moderate (56-70% HRR) and high (71-85% HRR) intensity.
15887315|NCT03748537|Drug|Hydrocortisone|After resuscitation, hypoperfusion in the sepsis patients will be treated by fluid resuscitation and vasopressor. Some groups of patients may be not responsive to this treatment (MAP <65 mmHg), administration of steroids to this group will be blindly randomized (treatment and control group). During resuscitation of septic shock patients with fluid resuscitation and vasopressors, some may not respond to treatment (MAP < 65 mmHg). Patients who have shock refractory to fluid resuscitation and norepinephrine therapy for more than 0.5 mcg/kg/min will be blindly randomized to receive steroid (treatment group) or placebo (control group). Blood samples will be obtained to determine mitochondrial functioning before, at day 1 and day 7 after administration of study medications in both groups.
15887316|NCT03748524|Drug|Influenza Vaccine|Influenza Vaccine,Quadrivalent SIngle vaccination all participants at day 0
15887317|NCT03748511|Other|fibroscan and stool sample|patients undergo ultrasaound (fibroscan) in order to stage the liver disease.
15887318|NCT03748498|Device|laser|Application of the laser was performed through root canal and to the buccal mucosa over the apices of the target tooth
15887319|NCT03748485|Behavioral|wait and watch|clinical local advanced colorectal cancer (cTxN1/2M0) following preoperational adjuvant therapies and pathologically proved stageⅡ(pT0-3N0M0),without(wait and watch) adjuvant chemotherapy
15887388|NCT03747952|Procedure|Tibiotalocalcaneal arthrodesis|Tibiotalocalcaneal (TTC) arthrodesis with a novel dynamic compression intramedullary nail.
15887320|NCT03748485|Drug|adjuvant chemotherapy|clinical local advanced colorectal cancer (cTxN1/2M0) following preoperational adjuvant therapies and pathologically proved stageⅡ(pT0-3N0M0),with adjuvant chemotherapy
15887321|NCT03489018|Biological|PCV10|Experimental arms will receive a lower dose of the intervention than the marketed dose.
15887322|NCT03489018|Biological|PCV13|Experimental arms will receive a lower dose of the intervention than the marketed dose.
15887323|NCT03748472|Procedure|Continuous gavage feeding|Each subject will serve as his or her own control. In this arm infants will receive their feed over 2 hours and the next feed will be given over 30 min and then over 2 hours again.
15887324|NCT03748472|Procedure|Bolus feeding|Each subject will serve as his or her own control. In this arm infants will receive their feed over 30 min and the next feed will be given over 2 hours and then over 30 minutes again.
15887325|NCT03748459|Other|Closure with Permanent Suture|Skin closure with permanent suture (prolene) (6-0 polypropylene) in open rhinoplasty.
15887326|NCT03748459|Other|Closure with Resorbable Suture|Skin closure with Resorbable Suture (5-0 fast absorbing plain gut) in open rhinoplasty.
15887327|NCT03748446|Drug|Xenon|The investigators have chosen to use as a maximum concentration about half the general anesthetic partial pressure of xenon (35%=70%/2) to achieve a dose that is sub-anesthetic. This concentration of xenon is very close to that at which subjects emerging from xenon anesthesia first respond to verbal commands, commonly referred to as MAC awake.
15887328|NCT03748446|Drug|Nitrogen gas|nitrogen-oxygen (35:65 ratio by volume) added to treatment as usual
15887329|NCT03748433|Device|Dexcom G6 CGM|Commercially available Dexcom G6 Continuous Glucose Monitoring
15887330|NCT03748433|Device|Tandem t:slim X2 Insulin Pump|sensor augmented insulin pump with predictive low glucose suspend
15887331|NCT03748420|Other|Adherence-enhanced clinical decision support|Clinical decision support system integrating electronic medication data with claims data on prescription fills
15887332|NCT03748420|Behavioral|ReachOut Adherence intervention|The pharmacist outreach intervention is based on the theoretically grounded and evidence-based Information-Motivation-Behavioral framework endorsed by the World Health Organization to improve adherence
15887333|NCT03748407|Other|Dosages of Thyroid parameters|Dosages of the following parameters: TSH, FT4 FT3, TGAb (Tyroglobulin antibody) , TPO Ab (ThyroPeroxydase Antibody)
15887334|NCT03748394|Behavioral|Work-directed rehabilitation|Each participant starts with a meeting together with an occupational therapist or a physical therapist, focusing on the participant's resources and obstacles for functioning well at work. A plan is designed and carried out over 8 weeks, including 1-4 different treatment modules of occupational and physical therapy, to support the person's ability to function at work
15887335|NCT03748394|Behavioral|Physical activity|In a meeting with a physical therapist, each participant receives advice on physical activity to support mental health, according to national recommendations. The participant is offered to train at a local gym during 8 weeks.
15887336|NCT03748381|Procedure|Cataract surgery|During cataract surgery patients will be implanted with the AT Zeiss Lisa tri in one eye and the Rayner trifocal in the contralateral eye
15887337|NCT03748368|Other|Cataract presentation|Presentation about cataract surgery
15887338|NCT03748368|Other|Placebo presentation|Presentation about the history of the hospital
15887339|NCT03748355|Genetic|Pharmacogentic Analysis|Participant will complete a buccal swab and it will be sent off to OneOme for analysis. When the results are available, the study investigators will review the medications for potential drug-drug and drug-genotype interactions. The risk for interactions will be classified as low, medium or high. The investigators will then communicate to the clinical team taking care of the patient these results and whether medication changes are recommended to minimize the drug-drug and drug-genotype interactions.
15887340|NCT03748342|Device|Second-Generation Laryngeal Mask Airway|A second-generation LMA will be used for airway management (instead of ETT).
15887341|NCT03748329|Device|Ultrasound|Will deposit local anaesthetic intra-orally with the aid of ultrasound to guide the location of the final deposition.
15887342|NCT03748303|Drug|Allopregnanolone|Administration of weekly IM injections of Allopregnanolone.
15887343|NCT03748290|Drug|Pregabalin|Pregabalin 75 mg for 12 weeks
15887344|NCT03748290|Drug|Placebo Oral Tablet|Placebo Oral Tablet
15887345|NCT03748277|Procedure|Decompression|Bilateral decompression
15887346|NCT03748277|Procedure|PLIF|Traditional open surgery
15887347|NCT03748277|Procedure|MIS TLIF|On the one side - Wiltse approach, on the other side - percutaneous
15887348|NCT03748277|Procedure|Screw Fixation|Transpedicular Screw Fixation
15887349|NCT03748264|Other|Standard of Care|In the standard of care or the control condition, participants will receive the sites therapy initiation standard of care for setting up and educating the participants on their Obstructive Sleep Apnea, mask, and device information. This group will use a wireless modem that is attached to the PAP device and uploads adherence and other therapy information daily to a secured database (Encore Anywhere). With this method, therapy information is not directly available to the participant but will continuously be available to site staff personnel.
15887350|NCT03748264|Device|DreamMapper Application|The DreamMapper application condition will receive the site's therapy initiation standard of care and will also download the DreamMapper application on their iPhone or Android smart phone. Therapy information and educational material will be available continuously to the participant with DreamMapper through the application. Study personnel will have access to adherence and therapy information continuously.
15887351|NCT03748264|Device|DreamMapper Application with Therapist Assist|The DreamMapper with Therapist Assist will review the Therapist Assist automated educational material on Obstructive Sleep Apnea, their Philips Respironics mask and DreamMapper. These participants will download the DreamMapper application onto their iPhone or Android smart phone. Therapy information and educational material will be available continuously to the participant with DreamMapper. Study personnel will have access to adherence and therapy information continuously.
15887352|NCT03748251|Other|the patients ate a pizza that fermented for 8 hours|Patients eat pizza prepared with controlled ingredients but fermented 8 hours
15887353|NCT03748251|Other|the patients ate a pizza that fermented for 24 hours|Patients eat pizza prepared with controlled ingredients but fermented 24 hours
15887389|NCT03747952|Device|DynaNail|Utilization of a novel dynamic compression pseudoelastic intramedullary nail
15898406|NCT03662100|Drug|LY3074828|Administered SC
15887354|NCT03748238|Procedure|Endometrial Injury with Hysteroscopy|All office hysteroscopy procedures will be done transvaginally under sedation with a 5 mm 30 degree lens supplied with a 5 F working channel continuous flow office hysteroscope (Bettocchi office hysteroscope, Karl Storz, Tuttlingen, Germany) without speculum or tenaculum. Briefly, following cervical passage and initial endometrial cavity investigation endometrial injury will be performed without energy modality (i.e. with scissors). Endometrial injury will perform first on the fundus by cutting into the endometrium (without injuring the myometrium) transversally. Later, vertical incisions will perform 0,5 cm apart each other, on the anterior and posterior walls of the uterus, 1-1.5 cm away from the fundus and one cut for each lateral wall
15887355|NCT03748212|Drug|D935 Cap. 1T|single oral administration under fed condition
15887356|NCT03748212|Drug|CKD-385 Tab. 1T|single oral administration under fed condition
15887357|NCT03748199|Drug|POL6014|"DL1 80 mg cohorts 1A and 1B (80 mg QD and 40 mg BID) DL2 160 mg cohorts 2A and 2B (160 mg QD and 80 mg BID) DL3 40 mg QD cohort C
~DL = dose Level QD= quaque die (once daily) BID= bis in die (twice daily)"
15887358|NCT03748199|Drug|Placebo|Placebo will be administered orally at a dose and frequency matched to POL6014
15887359|NCT03748186|Drug|STRO-002|intravenous antibody drug conjugate
15887360|NCT03748173|Combination Product|Aerosolized Infasurf|Infants randomized to aerosol treatment will receive Infasurf® aerosol at a rate of 12 ml/hour (the maximal rate using the Solaris CAG). The initial treatment will be for 60 minutes, with reevaluation every 30 minutes thereafter, with a maximum dose of 6 mL/Kg body weight or 2 hours of aerosolization. Treatment will be stopped after 60 minutes (and subsequently at 30-minute intervals) if a 2 point reduction in bronchiolitis score or a score ≤ 4 is achieved. Treatment will also be stopped at any time should there be evidence of other-than-transient deterioration in oxygenation or clinical status or for any serious adverse effect deemed by the infant's clinician to be possibly related to the drug administration.
15887361|NCT03748160|Other|Letter|Intervention consists of two different types of postal letters reminding elderly citizens (65 years and above) about influenza vaccines that are available free of charge from the local health centers
15887362|NCT03748147|Drug|Misoprostol|prostaglandin e1
15887363|NCT03748134|Biological|Sintilimab|For weight <60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1
15887364|NCT03748134|Drug|Placebo|For weight <60kg, 3mg/kg IV Q3W day 1, and for weight≥60kg, 200mg IV Q3W day 1
15887365|NCT03748134|Drug|Cisplatin|75mg/m^2 IV Q3W day 1
15887366|NCT03748134|Drug|Paclitaxel|87.5 mg/m^2 IV Q3W day 1, day 8 for first cycle and 175mg/m^2 IV Q3W day 1 after first cycle
15887367|NCT03748134|Drug|Fluorouracil|800 mg/m^2 IV continuous infusion over 24 hours daily on Days 1-5 Q3W
15887368|NCT03748121|Behavioral|Pranayama assisted trauma-focused Cognitive Behavioral Therapy (TF-CBT)|The pranayama intervention is placed directly at the begin of the respective TF-CBT unit and will be repeated for 10 subsequent TF-CBT units. Pranayama contains the performance of Kapalabhati, Ujjayi, and/or Nadi Shodhana (for overall 1 minute) as well as following Kumbhaka (intentional respiratory reflex inhibition). Pranayama will be repeated 3 times before each TF-CBT unit.
15887369|NCT03748121|Behavioral|Trauma-focused Cognitive Behavioral Therapy (TF-CBT)|Trauma-focused Cognitive Behavioral Therapy (TF-CBT)
15887370|NCT03748108|Drug|lidocaine|a bolus intravenous dose of 1.5 mg/kg lidocaine 2% over 15 s just before the induction of general anesthesia.
15887371|NCT03748108|Drug|Placebo|a bolus intravenous dose of 1.5 mg/ kg a saline placebo over 15 s just before the induction of general anesthesia.
15887372|NCT03748095|Drug|pipéracilline/tazobactam|There is not intervention description
15887373|NCT03748082|Drug|Nitric Oxide|Inhaled nitric oxide (iNO) will be administered via the CPB machine and after CPB via the inspiratory limb of the anesthetic or ventilator circuit, and thereafter via the mechanical ventilator in the ICU. Test gas administration will commence at the onset of CPB and last for 24 hours. At the end of 24 hours, iNO will be weaned and discontinued.
15887374|NCT03748082|Diagnostic Test|Reactive Hyperemia Index|Vascular responsiveness will be assessed with peripheral arterial tonometry which measures the transient increase in forearm blood flow (Reactive Hyperemia Index, RHI) in response to a five-minute occlusion of the brachial artery with a pressure cuff.
15887375|NCT03748082|Procedure|Endothelial Cells Collection|Endothelial cells are collected before and after surgery from a peripheral vessel using a soft J-shaped wire inserted through an intravascular catheter.
15887376|NCT03748056|Behavioral|Targeted incentives|Participants receiving individually-targeted incentives will receive weekly coupons for healthier foods that are informed by their purchase history, responses to behavioral and health questions, food preferences, and need for improvement in different categories
15887377|NCT03748056|Behavioral|Nominal loyalty card discount and nutrition education|All participants will receive a nominal discount on all groceries for using their loyalty card and nutrition education through weekly emails.
15887378|NCT03748043|Drug|Lactoferrin|lactoferrin 100 mg per day plus ferric hydroxide polymaltose 6 mg /kilogram of Elemental iron
15887379|NCT03748043|Drug|Ferric Hydroxide Polymaltose|group 2 will receive ferric hydroxide polymaltose 6 mg /kilogram of elemental iron
15887380|NCT03748030|Radiation|Confirmed Left-Sided Breast Cancer|Left-Sided Patients will receive standard radiation therapy, including 42.5 Gy in 16 fractions or 50 Gy in 25 fractions.
15887381|NCT03748017|Dietary Supplement|Placebo-Control Supplement|A once-daily oral dose of the placebo-control supplement will be consumed by adults for 14 consecutive days.
15887382|NCT03748017|Dietary Supplement|Streptococcus-Containing Probiotic Supplement|A once-daily oral dose of the streptococcus-containing probiotic supplement will be consumed by adults for 14 consecutive days.
15887383|NCT03748004|Behavioral|IPS/SP|The 72 recruited clients receiving primary care services from one DTES clinical site who are employment ready will be randomly assigned to IPS and Peer Support (experimental group) or WorkBC control group
15887384|NCT03748004|Behavioral|WorkBC|36 out of the 72 participants who live in the DTES will be randomly assigned to the control group (WorkBC). Participants will be provided with WorkBC employment services.
15887385|NCT03747978|Drug|Perindopril and Amlodipine|Fixed combination of Perindopril 5mg and Amlodipine 5mg
15887386|NCT03747978|Drug|Perindopril-indapamide|Perindopril 5mg and Indapamide 1.25mg
15887387|NCT03747965|Biological|Mesothelin-directed CAR-T cells|Cells will be infused one day after the completion of conditioning regimen of paclitaxel and cyclophosphamide
15887390|NCT03747939|Drug|Apremilast (CC-10004)|"Subjects randomized to apremilast will receive dose-titration for the initial 5 days. Apremilast subjects will receive dummy titration at wk. 16 (for early escape subjects) and again at week 24 to maintain the blinding of the original treatment assignments. Investigational product (IP) will be dispensed in blinded dose cards until Week 28. Thereafter, IP will be dispensed in open-label bottles."
15887391|NCT03747939|Other|Apremilast (CC-10004) Placebo|"Subjects randomized to placebo will receive dummy dose-titration for the initial 5 days. Placebo subjects who meet the criteria for early escape at wk. 16 may receive apremilast beginning at wk. 16 and will receive active titration. Remaining placebo subjects will receive active dose titration at week 24. Beginning at wk 24 all subjects will be dispensed active apremilast. Investigational product will be dispensed in blinded dose cards until Week 28. to maintain the blinding of the original treatment assignments. Thereafter, IP will be dispensed in open-label bottles"
15887392|NCT03747926|Drug|BI 705564|single-rising oral dose
15887393|NCT03747926|Drug|Placebo|single-rising oral dose
15887394|NCT03747913|Dietary Supplement|Antioxidative supplementation|Each participant conducts two identical cycling tests, first without and a week later with antioxidative supplementation
15887395|NCT03747900|Drug|Botulinum Toxin Type A|200 U Botulinum toxin type A injection in the spastic biceps brachii muscle.
15887396|NCT03747900|Combination Product|Botulinum Toxin Type A and dry needling.|Dry needling for 4 times in total in the spastic biceps brachii muscle after the Botulinum toxin type A injection.
15887397|NCT03747887|Behavioral|Daily Report Card|Students assigned to the DRC group will have a consultant assigned to the student for the duration of the school year. The consultant will work with the child's primary special education teacher (or regular education teacher if the child spends the majority of his or her day mainstreamed) to establish a DRC over the course of three consultation visits. The How to Establish a Daily Report Card manual contains a standard DRC instruction packet that is provided to teachers to explain the rationale of the DRC, procedures for creating, modifying, and evaluating the DRC, procedures for parents to create home-based rewards for DRC performance, and information on trouble-shooting.
15887398|NCT03747887|Other|School as Usual|The Individualized Education Program will be implemented as usual, with no additional study-related supports.
15887399|NCT03747874|Diagnostic Test|ventilatory polygraphy|we put a ventilatory polygraphy device on the patient in the evening, they come back home to sleep while the device is recording ventilatory parameters and they come back the morrow to give the device back
15887400|NCT03747861|Device|SenceBand|Wristband for registration of ECG RR intervals for one hand, SenceBand will collect data from 5-minutes intervals each 30 minute within 24 hours
15887401|NCT03747848|Behavioral|CBT group|Each interested individual will complete eligibility screening, consent form, and pre-intervention assessment. Demographic information such as gender, age, and number of years since diagnosis of PD will be collected. This investigator will implement the treatment program by meeting with the participants in groups, once a week, for six weeks. Group meetings will encourage interaction and support among group participants. Program content includes encouraging physical exercise with higher intensity, changing poor sleeping hygiene habits, stress management, and encouraging utilization of social support.
15887402|NCT03747835|Behavioral|Exposure and Response Prevention|Exposure and Response Prevention involves collaboratively developing a list of food-related fears with the patient and planning treatment sessions in which the patient is exposed to the fear and inhibits safety behaviors. The explicit goal of these exposure sessions will be to violate the patient's expectation regarding the feared stimulus, rather than to reduce fear.
15887403|NCT03747835|Behavioral|Motivational Interviewing|"Motivational interviewing techniques including reflective listening to demonstrate empathy and understanding, asking questions to elicit change talk (speech that is pro-change), evaluating the decisional balance, and managing or rolling with resistance will be incorporated throughout the treatment sessions."
15887404|NCT03747822|Procedure|fat filler,PEEK,sliding genioplasty|The procedure will be done under general anesthesia; the donor site lower abdomen, flank, lateral thigh, or inner thigh will be infused using a solution that consisted of 100 ml of normal saline with 50 mg (0.05%) of lidocaine and 0.1 ml of epinephrine. Liposuction will be performed using a 2-mm blunt cannula. A 20-cc syringe will be used to collect the fat. The fat will be injected into the chin in a supraperiosteal (subcutaneous) plane with a blunt 2-mm cannula using a fanning technique.
15887405|NCT03747809|Device|CIEDs Remote Monitoring System|Cardiac device remote monitoring system
15887406|NCT03747796|Other|Supine position|The children will be placed in the supine position after ingestion of a standard volume of clear fluid
15887407|NCT03747796|Other|Semi-sitting position|The children will be placed in the semi-sitting position after ingestion of a standard volume of clear fluid
15887408|NCT03747783|Procedure|Radical Operation|The surgery treatment selection was based on the American Joint Committee on Cancer stage both of the primary and of the recurrence, as well as on patterns of local spread that were not included in the T classification and on the general condition and preferences of each patient.
15887409|NCT03747770|Biological|Bivalent HPV vaccine CERVARIX®|Bivalent HPV vaccine(Glaxo Smith Kline, GSK, Rixensart, Belgium) presented as a suspension for intramuscular injection containing purified viral L1 protein for HPV types 16 and 18. Each 0.5 mL dose of the bivalent vaccine contains 20μg of HPV-16 L1 protein and 20 μg of HPV-18 L1 protein adsorbed onto a proprietary adjuvant system containing 500 μg of aluminum hydroxide and 50 μg of 3-O-desacyl-4-monophosphoryl lipid A (AS04)
15887410|NCT03747757|Behavioral|Cognitive Behavior Therapy|Undergo CBT
15887411|NCT03747757|Other|Quality-of-Life Assessment|Ancillary studies
15887412|NCT03747757|Other|Questionnaire Administration|Ancillary studies
15887413|NCT03747744|Other|CD1c (BDCA-1)+ myDC|Intratumoral injection in subcutaneous, cutaneous, soft tissue metastases
15887414|NCT03747718|Biological|Fecal Microbiota Transplantation|Fecal Microbiota Transplantation via colonoscopy for the first transplant in all subjects. This will be followed by 2 fecal enema transplants for all subjects 7 days (+/- 3 days) after colonoscopy. All subjects will be assessed 1.5 months (+/- 2 weeks) after colonoscopy. The subjects who are deemed responders based on a drop in PCDAI=12.5 or higher will be randomized to receive fecal or placebo enemas at 1 monthly (+/- 2 weeks) enemas at 1.5, 2.5 and 3.5 months after colonoscopy. All subjects will be assessed at 4.5 and 6 months (+/- 2 weeks) following colonoscopy. The study will be completed at 6 months (+/- 2 weeks) following colonoscopy.
15898407|NCT03662100|Device|Auto-injector (AI)|AI to administer LY3074828
15887415|NCT03747718|Other|Placebo|Fecal Microbiota Transplantation via colonoscopy for the first transplant in all subjects. This will be followed by 2 fecal enema transplants for all subjects 7 days (+/- 3 days) after colonoscopy. All subjects will be assessed 1.5 months (+/- 2 weeks) after colonoscopy. The subjects who are deemed responders based on a drop in PCDAI=12.5 or higher will be randomized to receive fecal or placebo enemas at 1 monthly (+/- 2 weeks) enemas at 1.5, 2.5 and 3.5 months after colonoscopy. All subjects will be assessed at 4.5 and 6 months (+/- 2 weeks) following colonoscopy. The study will be completed at 6 months (+/- 2 weeks) following colonoscopy.
15887416|NCT03747705|Other|An App for reminding patients to take their medication|Open-label, single-center study, up to 20 adults (>18) male and female with, intractable epilepsy, on stable doses of antiepileptic drugs (AEDs), will participate in a 4-week observation period during which no change in the drugs is permitted. The patients will then begin 10-week treatment by taking their medications according to a semi-random schedule that is pre-set for them by the physician using the same drugs the patient is taking and only changing the dose and times of taking them each day while keeping the drugs within their therapeutic window. Between 6:00-22:00 During the study, patients will fill a seizure diary daily.
15887417|NCT03747692|Procedure|study group|local anesthesia by mepicaine hydrochloride by intracervical local injection using 10 mm syringe.
15887418|NCT03747692|Procedure|control group|each patient receives one tablet of NSAIDs (diclofenac sodium 50 mg) and 5ml of a placebo in form of normal saline are injected intracervical 5 minutes before the procedure using 10 mm syringe.
15887419|NCT03747679|Drug|200 Mg capsules of bosutinib in Water solution|200 mg (4X50) Capsules in water
15887420|NCT03747679|Drug|bosunitib sorbitol|200 Mg of bosutinib sorbitol solution
15887421|NCT03747679|Drug|Bosutinib Mannitol|Bosutinib mannitol solution
15887422|NCT03747679|Drug|bosutinib in mannitol low sweet|bosutinib in mannitol solution low sweet
15887423|NCT03747679|Drug|bosutinib in mannitol high sweet|bosutinib in mannitol high sweet
15887424|NCT03747679|Drug|bosutinib taste low flavour|bosutinib solution low flavour
15887425|NCT03747679|Drug|bosutinib high flavour|bosutinib solution high flavour
15887426|NCT03747679|Drug|bosutinib capsules in applesauce|Bosutinib capsules in applesauce
15887427|NCT03747679|Drug|Bosutinib capsules in yogurt|bosutinib capsules in yogurt
15887428|NCT03747679|Drug|bosutinib capsules in water|sham comparator, bosutinb in water retest
15887429|NCT03747679|Drug|Bosutinib capsules in low sweet|bosutinib capsules in low sweet
15887430|NCT03747679|Drug|bosutinib capsules high sweet|Bosutinib capsules high sweet
15887431|NCT03747679|Drug|bosutinib capsules low flavour|Bosutinib capsules low flavour
15887432|NCT03747679|Drug|bosutinib capsules high flavour|bosutinib capsules in high flavour
15887433|NCT03747666|Procedure|2.0 single locking miniplates|The fractured segments in the parasymphyseal region will be fixed using 2.0 single locking miniplates placed on the inferior border of the mandible.
15887434|NCT03747653|Drug|ADVATE|Patients will be administered a single dose of ADVATE.
15887435|NCT03747653|Drug|FRSW107|Patients will be administered a single dose of FRSW107 for Injection.
15887436|NCT03747640|Device|Self Transcranial Direct Current Stimulation (tDCS)|tDCS with a constant current intensity of 2 milliamps (mA) will be applied for 20 minutes per session daily for 2 weeks (Monday to Friday) via the Soterix 1x1 tDCS mini-CT Stimulator device (Soterix Medical Inc., New York; 6.5 inches long, 3 inches wide, 0.7 inches thick) with headgear and 5x7 cm saline-soaked surface sponge electrodes.
15887437|NCT03747640|Behavioral|mindfulness-based meditation|The meditation intervention will be delivered by a recorded device that participants will be given together with the tDCS. All meditation instruction recordings will be done by an experienced mind-body intervention specialist and installed in a user-friendly MP3 player.
15887438|NCT03747640|Device|Sham Self Transcranial Direct Current Stimulation (tDCS)|For sham stimulation, the electrodes will be placed in the same positions as for active stimulation, but the stimulator will only deliver 2 mA current for 30 seconds.
15887439|NCT03747640|Behavioral|sham meditation|For sham meditation, the participants will be instructed, approximately every 2-3 minutes, to take deep breaths as we sit in meditation. Time spent giving instructions in the sham meditation intervention will be matched to time spent in the mindfulness intervention.
15887440|NCT03747627|Diagnostic Test|Genetic profiling|All participating subjects will undergo detailed genetic analysis, with the aim of detecting novel genetic drivers for the development of interstitial lung disease in the context of known sensitising agent (pigeon antigen)
15887441|NCT03747614|Drug|Fluorometholone|"Fluorometh010neEyeDrops:
~Brand names: Allergan Pharmaceuticals Ireland, Serial number: J20130061, NDC 60758-880-05. Tacrolimus Brand names: Senju Pharmaceutical Co., Ltd. Fukusaki Plant Serial number: H20130452"
15887442|NCT03747614|Device|Functional Slit-Lamp Biomicroscopy|A traditional slit lamp (HAAG-STREIT SWISS MADE 900.7.2.34925) was used, and a digital camera (Canon 60D. Canon Inc, Melville, NY) was attached via an inherent camera port. Custom software was used to measure the conjunctival microvascular BFV and vessel diameter using a protocol that has been previously described in detail. At baseline, video clips were recorded on six fields of the bulbar conjunctiva, which was approximately 1 mm from the limbus. During the follow-up visits, attention was given to relocating the vessel segments for these 6 fields.
15887443|NCT03747601|Device|Temporal Interference (TI) Stimulation|2-4 Temporal Interference stimulation sessions. The device is an experimental non-invasive electrical brain stimulator that functions similar to existing non-significant risk devices for electrical stimulation, including human non-invasive brain stimulation. Briefly, the device produces alternating current electrical stimulation in a kilohertz (kHz) range and results in less net charge applied within the brain. The device is powered by rechargeable 20 volt (V) battery (i.e. there is no connection to building power supply). The current is hardwired and limited to 5 milliamp (mA) via internal resistors. It includes extra safety features such as onboard fuses to limit any abrupt high current, and an emergency stop button which effectively insulates the subject and resets the device. The device was tested and characterized at all the required load conditions.
15887444|NCT03747588|Other|Laparoscopic pancreaticoduodenectomy|Laparoscopic resection of pancreatic tumor
15887445|NCT03747588|Other|Open pancreaticoduodenectomy|open resection of pancreatic tumor
15887446|NCT03747575|Drug|MSTT1041A|Participants will receive subcutaneous (SC) MSTT1041A
15887447|NCT03747575|Drug|Placebo|Participants will receive SC placebo
15887448|NCT03747562|Drug|Gabapentin|Gabapentin will be administrated orally, with or without food, and should be swallowed with sufficient fluid intake (e.g. a glass of water). Since head and neck cancer patients frequently experience swallowing difficulties, gabapentin capsules will be provided to enable opening of the capsule and use of the contents for mixture with food or liquids. Moreover, gabapentin powder can be dissolved in water to enable injection of the drug into a percutaneous endoscopic gastrostomy tube.
15887449|NCT03747562|Other|Placebo|Placebo will be administrated orally, with or without food, and should be swallowed with sufficient fluid intake (e.g. a glass of water). Since head and neck cancer patients frequently experience swallowing difficulties, placebo capsules will be provided to enable opening of the capsule and use of the contents for mixture with food or liquids. Moreover, placebo powder can be dissolved in water to enable injection of the drug into a percutaneous endoscopic gastrostomy tube.
15887450|NCT03747549|Other|Acupuncture and Home Exercise|Acupuncture (needles will be placed at BL 60, BL 61, KI 3, KI 4 with needles directed into the Achilles tendon. Needles inserted until a firm catch of the needle entering the tendon was appreciated. Energy (a small electrical current) is placed from KI 3(-) KI 4(+) and BL 61 (-) BL 60(+) at 30 Hz for 15min) plus the prescribed home exercise program
15887451|NCT03747549|Other|Home Exercise Alone|The prescribed home exercise program alone.
15887452|NCT03747536|Drug|Ipratropium bromide|ipratropium bromide via metered dose spray (21 micrograms per spray)
15887453|NCT03747536|Other|Placebo|normal saline delivered via metered dose spray
15887454|NCT03747523|Drug|Ergocalciferol|Investigational drug will be administered to eligible participants in a single dose of 200,000 USP units vitamin D
15887455|NCT03747510|Device|CarpX Device|Transverse carpal ligament release with CarpX Device
15887456|NCT03747497|Drug|contezolid acefosamil|IV and oral contezolid acefosamil given twice a day for 10 to 14 days
15887457|NCT03747497|Drug|linezolid 600 mg|IV and oral linezolid given twice a day for 10 to 14 days
15887458|NCT03747484|Biological|Autologous MCPyV-specific HLA-A02-restricted TCR-transduced CD4+ and CD8+ T-cells FH-MCVA2TCR|Given IV
15887459|NCT03747484|Drug|Avelumab|Given IV
15887460|NCT03747484|Biological|Pembrolizumab|Given IV
15887461|NCT03747484|Radiation|Radiation Therapy|Undergo radiation therapy
15887462|NCT03747471|Behavioral|Diabetic Conversation Map|"Diabetic Conversation Map education tools are a series of tools for facilitated group education 5-8that were developed by Healthy Interactions in collaboration with the International Diabetes Federation (IDF) and are sponsored by Lilly Diabetes.
~CM-based education guides people with diabetes through a process with the aim of helping them understand and internalize information about their disease and generate insightful conclusions, which may then result in improved self-management decisions and actions."
15887463|NCT03747458|Drug|OPN-375|OPN-375, BID
15887464|NCT03747445|Procedure|Roux-en-Y gastric bypass|laparoscopic surgical procedure
15887465|NCT03747432|Drug|Propofol|Conscious sedation during TAVR procedure using propofol
15887466|NCT03747432|Drug|Dexmedetomidine|Conscious sedation during TAVR procedure using dexmedetomidine
15887467|NCT03747419|Drug|Avelumab|Avelumab is a form of immunotherapy, which means it is designed to help the patient's immune system kill cancer cells.
15887468|NCT03747419|Radiation|Radiation|Cancer treatment that uses ionizing radiation to kill cancer cells.
15887469|NCT03747406|Procedure|Erector spinae plane block|the level between T9 and T10 will be identified using ultrasound as well as transverse processes depth. An array probe will be applied longitudinal orientation 3 cm lateral midline. The erector spinae and the psoas muscle will be identified. A skin wheal will be made using lidocaine 1% at each level and then a 22-gauge Tuohy needle will be advanced inplane until it made contact with the transverse process. The needle will be withdrawn slightly and 30cc of bupivacaine 0.25 % (15ml for each side) will be injected slowly after negative aspiration was confirmed. The same procedure will be repeated in the contralateral side.
15887470|NCT03747406|Procedure|TAP block|a linear array transducer 5-12 MHz will be positioned inferior and parallel to the costal margin in a medio-lateral orientation. The external oblique, internal oblique and transverse abdominis muscles will be identified immediately lateral to the linea semilunaris. A a 22-gauge needle will be advanced medially and in-plane to the US beam until the tip lies between the fascia of the internal oblique muscle and the transverse abdominis muscle layers. 30 ml of 0.25 % bupivacaine will be injected in each side and the spread will be observed between the two muscles layers.
15887471|NCT03747393|Behavioral|DoD/VA CPG Core Set + PT|Participants randomized to receive the core set management class and physical therapy will be scheduled for their initial physical therapy evaluation approximately 1 week from their enrollment date. The purpose of the evaluation will be to identify relevant impairments that can be addressed during the physical therapy treatments. After this initial evaluation, the goal is for the patient to receive approximately 4 weeks of physical therapy (about 8-10 sessions in the clinic 2-3 times per week). Consistent with a pragmatic study we will not use placebos to blind patients or attempt to balance provider contact.
15887472|NCT03747393|Behavioral|DoD/VA CPG Core Set|The published clinical practice guideline recommends early use of a core set of management strategies to include patient education about their condition and the role of obesity in disease progression, activity and lifestyle modification focusing on physical activity, and a therapeutic exercise program. Implementation of the core set is recommended prior to any referral for consultation about invasive procedures such as intra-articular injections or TKA surgery. All patients with knee pain will be scheduled to receive the core set management strategy class as a part of the usual care route.
15887473|NCT03747380|Other|inspiratory muscle program|pre-operative inspiratory muscular training program
15887474|NCT03747367|Behavioral|Insufficient Sleep|
15887475|NCT03747354|Diagnostic Test|blood samples|blood samples
15887476|NCT03747341|Drug|Buprenorphine Injectable Solution - Part A|"Buprenorphine intravenous (IV) injection given as a primed-continuous infusion.
~Low Dose: initial bolus (0.05 mg/70 kg) administered over 15 minutes and infusion continued (0.02 mg/70 kg/hour infusion rate) to complete 360 minutes of administration targeting 0.2 ng/ml.
~High Dose: initial bolus (0.125 mg/70 kg) administered over 15 minutes and infusion continued (0.05 mg/70 kg/hour infusion rate) to complete 360 minutes of administration targeting 0.5 ng/ml.
~Administration of buprenorphine was flexible and infusion rates were selected to target approximately 25 to 50% respiratory depression."
15887747|NCT03745118|Device|EpiTel EpiLog|Plastic pad that is about the size of a house key, and will be adhered to your scalp with gel
15887477|NCT03747341|Drug|Placebo - Parts A + B|0.9% normal saline for IV administration was used as placebo matching the buprenorphine formulation and administration.
15887478|NCT03747341|Drug|Fentanyl - Part A|Participant received up to four fentanyl doses: 0.075, 0.15, 0.25, and 0.35 mg/70 kg in Periods 1 and 2. Fentanyl boluses were administered over 90 seconds by dose escalation +2hr, +3hr, +4hr and +5hr after starting administration of buprenorphine/ placebo. Administration of fentanyl was flexible and bolus doses were selected to elicit moderate to more severe respiratory depression with apnoea ≥20 seconds.
15887479|NCT03747341|Drug|Ondansetron - Parts A + B|A non-investigational intervention administered as an infusion prior to investigation intervention. 4 mg of ondansetron was administered to manage the expected gastrointestinal side effect (nausea, vomiting) to buprenorphine.
15887480|NCT03747341|Drug|Buprenorphine Injectable Solution - Part B|"Buprenorphine intravenous (IV) injection given as a primed-continuous infusion.
~Low Dose: initial bolus (0.25 mg/70 kg) administered over 15 minutes and infusion continued (0.1 mg/70 kg/hour infusion rate) to complete 360 minutes of administration targeting 1 ng/ml.
~Mid Dose: initial bolus (0.5 mg/70 kg) administered over 15 minutes and infusion continued (0.2 mg/70 kg/hour infusion rate) to complete 360 minutes of administration targeting 2 ng/ml.
~High Dose: initial bolus (1.25 mg/70 kg) administered over 15 minutes and infusion continued (0.5 mg/70 kg/hour infusion rate) to complete 360 minutes of administration targeting 5 ng/ml."
15887481|NCT03747341|Drug|Fentanyl - Part B|"Participant received up to four fentanyl doses: 0.25, 0.35, 0.5, and 0.7 mg/70 kg in Periods 1 and 2.
~Fentanyl boluses were administered over 90 seconds by dose escalation +2hr, +3hr, +4hr and +5hr after starting administration of buprenorphine/ placebo."
15887482|NCT03747341|Drug|Oxycodone - Part B|All opioid-tolerant participants in Part B were transitioned to oral oxycodone at least 48 hours before Period 1 to ensure washout of the participants' regular opioids and a stable dose of oxycodone with an adequate bridging schedule reached. Oxycodone is a non-investigational intervention.
15887483|NCT03747328|Drug|ABI-009|nanoparticle albumin bound sirolimus
15887484|NCT03747315|Other|In vitro functional test|Measurement of interleukin-1beta secretion by monocytes and measurement of cell death upon Pyrin inflammasome activation by kinase inhibitor on an additional blood sample (4 ml for children under 12 and 10 ml for children 12 years and older and adults) during a sample for patient care.
15887485|NCT03747315|Other|In vitro functional test|Measurement of interleukin-1beta secretion by monocytes and measurement of cell death upon Pyrin inflammasome activation by kinase inhibitor on samples from healthy subjects who donated their blood to the French Blood Establishment.
15887486|NCT03747302|Other|Social Media Message about HPV and HPV vaccine|Messages educate parents with facts about HPV vaccination.
15887487|NCT03747302|Other|Social media message about risk of electronic cigarettes.|Messages educate parents with facts about electronic cigarettes. This is an attention control group without outcomes obtained.
15887488|NCT03747289|Other|performing exercises in a weight bearing posture|20 participants will perform exercises in a weight bearing posture
15887489|NCT03747289|Other|performing exercises in a non weight bearing posture|20 participants will perform exercises in a non weight bearing posture
15887490|NCT03747276|Other|Clinical Trial Kiosk|Kiosk will consist of a patient facilitator and a computer with access to general information about clinical trials and information specific to active clinical trials at the facility. Patients will be made aware of the kiosk via a large banner visible in the clinic above the kiosk.
15887491|NCT03747263|Procedure|Catheter ablation|Electrophysiology studies are performed during conscious sedation using boluses of midazolam and fentanyl and a continuous infusion of propofol. Vital parameters are continuously monitored. One 7F standard diagnostic catheter is positioned inside the coronary sinus (CS) via the femoral vein. One 8,5-F sheath is advanced to the left atrium (LA). After transseptal catheterization, intravenous heparin is administered to target an activated clotting time of ≥300 seconds. PV angiographies are obtained for each PV and PV recordings are registered at baseline in SR. The 8.5F transseptal sheath (TS) is changed over the wire for a 12F steerable TS.
15887492|NCT03747250|Device|Videolaryngoscopy|In experimental group (interventional group), patients will be intubated with the videolaryngoscope
15887493|NCT03747250|Device|Direct laryngoscopy|In control group (active comparator group), patients will be intubated with the direct laryngoscope
15887494|NCT03747237|Other|Edema measurement methods|A correlation between the results of the first and second methods will be examined.
15887495|NCT03747224|Drug|ARO-ANG3|single or multiple doses of ARO-ANG3 by subcutaneous (sc) injections
15887496|NCT03747224|Drug|sterile normal saline (0.9% NaCl)|calculated volume to match active treatment
15887497|NCT03747211|Behavioral|Aerobic exercise|High Intensity Interval Training (HIIT)
15887498|NCT03747198|Dietary Supplement|methylsulfonylmethane|Subjects will be given 2 g/day methylsulfonylmethane.
15887499|NCT03747198|Other|Placebo|Subjects will be given 2 g/day placebo (rice flour).
15887500|NCT03747185|Other|Lumbopelvic stiffening technique|"Participants will stretch the hamstrings muscle in standing position with lumbopelvic stiffening technique. Fifteen percent of the body weight will be used to standardize stretching force. During stretching protocol, the participants will be instructed to face the hydraulic table with the hips square, maintain trunk straight up and look straight ahead. Researcher commands during adjusting the bed up, please tense the back rigid. After that, hydraulic bed will be lifted up until force reaches 15 percent of the body weight. Participant will perform 30 seconds/repetition for 4 repetitions with 15 seconds rest between repetitions."
15887501|NCT03747185|Other|Lumbopelvic relaxing technique|"Participants will be instructed to face the hydraulic table with the hips square, maintain trunk straight up and look straight ahead. The researcher commands During adjusting the bed up, please relax the back. The hydraulic bed will be lifted up until force reaches 15 percent of the body weight. Participant will perform 30 seconds/repetition for 4 repetitions with 15 seconds rest between repetitions."
15887502|NCT03747172|Dietary Supplement|complementary and alternative therapy|complementary and alternative therapies were grouped into five main categories: (1) biologically based therapies , (2) mind/body therapies, (3) manipulative and body-based therapies, (4) Energy therapies and (5) alternative medical systems.
15887503|NCT03747159|Drug|Belimumab Injection|Weekly injection of belimumab prior to two infusions of rituximab with continuation of the belimumab as maintenance therapy
15887748|NCT03745118|Device|Byte Flies Sensor Dots|Plastic pads that will be adhered to your chest area
15887504|NCT03747146|Device|Continuous Adductor Canal Catheter (ACC)|At the end of the case or in the PACU, a pseudo sham catheter will be affixed mid-thigh to the skin using dermabond, steri-strips, and a chg tegaderm dressing. The catheter will be connected to the disposable pump filled with sterile saline (400 cc) and the flow rate will be set to 0. The pump will be enclosed in a carrier bag provided by the company. To ensure blinding, the carrier bag will be taped to prevent the patient from accessing it.
15887505|NCT03747146|Device|Adductor Canal block with sham catheter|Adductor canal block (ACB) will be administered. At the end of the case or in the PACU, a catheter will be inserted and affixed mid-thigh to the skin using dermabond, steri-strips, and a chg tegaderm dressing. The catheter will be connected to the disposable pump filled with sterile saline (400 cc) and the flow rate will be set to 0. The pump will be enclosed in a carrier bag provided by the company. To ensure blinding, the carrier bag will be taped to prevent the patient from accessing it.
15887506|NCT03747133|Radiation|Stereotactic Ablative Radiotherapy|Stereotactic Ablative Radiotherapy to renal tumors with a dose of 27.5-40 Gy in 5 fractions.
15887507|NCT03747120|Drug|Paclitaxel|All subjects will receive Paclitaxel weekly for 12 weeks
15887508|NCT03747120|Drug|Trastuzumab|All subjects will receive Trastuzumab every 3 weeks
15887509|NCT03747120|Drug|Pertuzumab|Arm A and Arm B subjects will receive Pertuzumab every 3 weeks
15887510|NCT03747120|Drug|Pembrolizumab|Arm B and Arm C subjects will receive Pembrolizumab every 3 weeks
15887511|NCT03747107|Behavioral|P-DQIP|The 'intervention' is a health board quality improvement programme to be implemented across all practices in one Scottish NHS health board and comprises the following components: (i) Case finding via the P-DQIP informatics tool to identify patients with drug therapy risks for review; (ii) Decision support via the P-DQIP informatics tool to facilitate medication reviews; (iii) Practice pharmacists will be trained on the use of the P-DQIP informatics tool and instructed to target patients at risk of bleeding and hypoglycaemia first (iv) Ongoing performance feedback. Practices and locality pharmacists will be able to access reports on review activity and targeted prescribing; (v) promotion of the P-DQIP tool and intervention among GP practices. The P-DQIP intervention will be evaluated in all NHS Tayside practices who agree to share their data for monitoring and evaluation purposes.
15887512|NCT03747094|Drug|Fentanyl|0.5 mic/kg fentanyl will be given immediately before the procedure
15887513|NCT03747094|Drug|Ketamine|0.25 mg ketamine will be administered immediately before the procedure
15887514|NCT03747081|Drug|Rivaroxaban|Rivaroxaban will administrate to patient with CVT. In first day, enoxaparin is injected to patients and the next day, patients will receive Rivaroxaban and enoxaparin discontinue. Then, patients receive Rivaroxaban for 3 months daily.
15887515|NCT03747081|Drug|Warfarin|Warfarin as a antocoagolant drug will administrate to patient with CVT. In first day, Warfarin plus enoxaparin until adjusting INR index to 2-3. Then, patients receive warfarin for 3 months daily.
15887516|NCT03747068|Drug|Anti-TNF Drug|
15887517|NCT03747055|Behavioral|Group problem management plus|Low intensity group psychological intervention including stress management, behavioral activation, problem solving, and strengthening social support
15887518|NCT03747055|Behavioral|Enhanced treatment as usual|Referral to primary care workers trained in mental health Gap Action Program Implementation Guide
15887519|NCT03747042|Drug|Letrozole|Patients will receive a prescription for letrozole to be taken orally for 7-56 days to allow for variations in surgical scheduling. Patients are to undergo surgical resection of their tumor the day after the last dose of letrozole. Post-treatment tumor biopsies (a goal of 4-6 cores) will be obtained following 7-56 days of letrozole treatment on the day of surgery.
15887520|NCT03747029|Other|No intervention is provided|No intervention is provided
15887521|NCT03747016|Dietary Supplement|high-energy digestible food E2|The women undergoing Cesarean section are given high energy digestible food 300ml before surgery
15887522|NCT03747016|Dietary Supplement|glucose injection G2|The women undergoing Cesarean section are given glucose injection 300ml before surgery
15887523|NCT03747016|Dietary Supplement|normal saline N2|The women undergoing Cesarean section are given normal saline 300ml before surgery
15887524|NCT03747016|Dietary Supplement|high-energy digestible food E1|The women in delivery room are given high energy digestible food 300ml.
15887525|NCT03747016|Dietary Supplement|glucose injection G1|The women in delivery room are given glucose injection 300ml.
15887526|NCT03747016|Dietary Supplement|normal saline N1|The women in delivery room are given normal saline 300ml.
15887527|NCT03747003|Other|No intervention is provided|No intervention is provided
15887528|NCT03746977|Dietary Supplement|Protein|Protein supplementation 1.2 or 1.5 g/kg body mass/d
15887529|NCT03746977|Behavioral|Walking|Walking with a volume corresponding to 250 kcal/d
15887530|NCT03746977|Behavioral|WB-EMS application|WB-EMS application 1.5x 20 min/week
15887531|NCT03746964|Procedure|Cardiac MRI|Preoperative cardiac MRI
15887532|NCT03746964|Other|in-vitro elasticity tests|in-vitro elasticity tests performed on a segment of ascending aorta collected during surgery
15887533|NCT03746951|Drug|Ropivacaine Hcl 0.5% Inj Vil 20Ml|Anesthetic agent used in peripheral nerve block
15887534|NCT03746938|Device|VB-C01|Surgical implant of VB-C01 (Collagen membrane seeded with allogeneic stem cells isolated from adipose tissue, ADSC).
15887535|NCT03746925|Procedure|Direct Anterior Approach (DAA)|Direct Anterior Approach surgery to replace the hip.
15887536|NCT03746925|Procedure|SuperPATH|SuperPATH approach surgery to replace the hip.
15887537|NCT03746912|Drug|Quizartinib Dihydrochloride|Tablets for once daily oral administration at doctor-recommended dose in continuous 28-day cycles
15887538|NCT03746899|Biological|PLX-PAD|PLX-PAD cell therapy to be administered via 30 IM injections (0.5 mL each) to the index leg leg per treatment, in each of two treatments, 8 weeks apart
15887539|NCT03746886|Other|Breast-milk|A single breast-milk sample will be collected from 20 women. Milk samples will be pooled for analysis.
15887626|NCT03746080|Radiation|Whole-Brain Radiotherapy (WBRT)|Undergo Whole brain radiotherapy (WBRT) - Radiotherapy consists of 30 Gy in 15 fractions of whole brain radiations
15887627|NCT03746080|Radiation|Radiation Therapy|Radiotherapy consists of 30 Gy in 15 fractions
15887628|NCT03746067|Drug|TS-134|5 mg, 10 mg, or 20 mg oral solution
15887629|NCT03746067|Drug|Placebo|Matched Placebo oral solution
15887749|NCT03745118|Device|Empatica E4|wearable seizure detection wristband
15887540|NCT03746873|Behavioral|COPD Web|"The COPD Web will be introduced to the participant randomized to intervention by a letter containing a code to get access to the web site and how to create an account and login. At the web site there will be an instruction movie showing/ discussing specific content on the COPD Web. The web site will be self-managed. To secure that there is no technical or user problems participants will be contacted by a researcher the first week of intervention.
~Participants will receive push notifications (email) with targeted information containing links to the COPD Web and reminder to register the number of steps walked during that week. The push notifications will come every week (week 1-12), every other week (week 12 to 24) and every fourth week (week 24-52)."
15887541|NCT03746860|Drug|Tablet, Dispersible|1 tablet/day with 12 SQ-HDM per lyo-tablet
15887542|NCT03746847|Drug|Gallium-68 DOTATATE|Gallium-68 DOTATATE is a radioactive tracer, a type of imaging drug that is labeled with a radioactive tag and injected into the body, which is approved by the U.S. Food and Drug Administration (FDA) to diagnose certain tumors.
15887543|NCT03746834|Device|NASHA/Dx (Solesta®)|Perianal submucosal injection of 3-4 ml of NASHA/Dx
15887544|NCT03746821|Dietary Supplement|Biotin|Biotin supplements (2) to be taken daily
15887545|NCT03746808|Behavioral|EMA + App/Treatment Messages|"This study will develop and test a just-in-time adaptive intervention to reduce alcohol use among homeless adults. Phase I will use smartphones and passive sensing to monitor geolocation, psychosocial variables (e.g., stress, urge to drink), and alcohol use in a group of 80 homeless adults with an AUD who are enrolled in shelter-based treatment. Phase II will use this information to create a risk algorithm and tailored treatment messages that anticipate and intervene to prevent alcohol use."
15887546|NCT03746795|Device|Spirometric examinations realized using the EIT|Spirometric examinations will be realized using the EIT alone.
15887547|NCT03746795|Device|Simultaneous measurement by spirometer and EIT|Spirometric examinations will be realized using the simultaneous measurement by spirometer and EIT
15887548|NCT03746782|Diagnostic Test|Flow Cytrometry; Thrombin Generation Assay|Apixaban combined with blood specimens (in vitro) of study participants
15887549|NCT03746769|Biological|Allogenic Human Islet Cells|islet cells transplanted into the portal vein in the liver
15887550|NCT03746769|Drug|Gastrin 17|"Gastrin-17 (or GAST-17) - a gut hormone injected under the skin twice daily for 30 days soon after islet transplant and again 6 months later.
~Also, anti-rejection medications (to prevent the body from rejecting the islet cells) and other medications to guard against infection and support participant health and/or the health of the transplanted islets."
15887551|NCT03746756|Behavioral|SBIRT|"As part of regular practice FQHC screen patients at least once a year with the Alcohol Use Disorders Identification Test (AUDIT) to identify alcohol problems and Drug Abuse Screening Test (DAST) to identify drug problems. Those who are the most severed and referred to treatment are approached about participating in the study."
15887552|NCT03746756|Behavioral|SBIRT+RMC-PC|In addition to SBIRT, those randomly assigned to the experimental condition will also receive Recovery Management Checkups for Primary Care (RMC-PC) at the time of referral/study enrollment and quarterly for 12 months. RMC-PC involves a linkage manager reviewing the assessment data and using motivational interviewing to encourage the person to go to treatment and identify barriers to entering or staying in treatment. It also involves problem solving on how to address common issues (e.g., transportation, scheduling), staying in regular contact for the first two weeks to make sure they stay in treatment, and checking in on continuing care compliance at later checkups.
15887553|NCT03746743|Diagnostic Test|score for neonatal sepsis|score for neonatal sepsis to predict morbidity
15887554|NCT03746730|Device|ultrasound|gray scale and doppler ultrasound
15887555|NCT03746717|Device|occlusive wound closure|skin closure with a commercially available wound closure product consisting of a synthetic adhesive mesh and cyanoacrylate based skin glue
15887556|NCT03746717|Device|conventional wound closure|wound closure with surgical staples
15887557|NCT03746704|Drug|89Zr˗DFO˗REGN3504|89Zr˗DFO˗REGN3504
15887558|NCT03746691|Drug|Citalopram HCl|Citalopram HCl IV 20 mg in 100 ml saline will be infused IV over the course of 30 minutes. Volunteers will receive a standard meal, and recordings using high resolution impedance manometry, will be continued for 2 hours.
15887559|NCT03746691|Drug|Placebos|Placebo (100 ml saline IV) will be infused IV over the course of 30 minutes. Volunteers will receive a standard meal, and recordings using high resolution impedance manometry, will be continued for 2 hours.
15887560|NCT03746678|Other|C-Care Mobile Application|C-care is a mobile application developed based on previous research at the IWK Health Centre. It contains topics relevant to Cesarean delivery and the recovery process, which the patient could access at anytime. Patient engagement with the application will be monitored anonymously for 30 days after delivery. On days one to five after delivery, patients will receive a short self-monitoring questionnaire (approximately 1 minute). At the end of two weeks (14 days), patients will complete an online survey regarding overall satisfaction, potential impact on care, usability and feasibility problems. At any point during the study, patients can email us to report any problems with the application.
15887561|NCT03746665|Biological|meningococcal serogroup A conjugate vaccine|Once final eligibility has been confirmed by a study clinician on the day, expectant mothers will be administered a single intramuscular dose of MenAfriVac™.
15887562|NCT03746652|Drug|Daratumumab, Ixazomib, Dexamethasone|Daratumumab 16 mg/kg, Ixazomib 4 mg, Dexamethasone 40 mg
15887563|NCT03746639|Other|physiotherapy modalities|"The physiotherapy modalities will be applied for five sessions a week for 3 weeks.
~The all patients will be treated with superficial heating (the moist heat pack will be applied to the patient's lower back for 20 minutes) , transcutaneous electrical nerve stimulation(frequency of 100 Hz, pulse duration of 100 μs, sensory-level amplitude was applied for 25 minutes) , exercise therapy (consisting of flexion, extension, stretching, mobilisation, and postural exercises performed for approximately 25 minutes ) .
~In addition to these therapies, continuous therapeutic ultrasound treatment will be applied to patients in first group for 10 minutes; frequency of 1 megahertz, intensity of 1.5 W/cm2, effective irradiation area of the transducer head 5 cm2 ."
15887564|NCT03746626|Behavioral|Chaplain visit|The patients will all see a chaplain routinely during 8-week stay according to their personal preference. The chaplain records the 'depth' and frequency of these encounters.
15887565|NCT03746613|Device|HEARO|Robotic system for otological procedures
15887750|NCT03745118|Device|Biovotion Everion|wearable seizure detection device armband that is attached to upper arm
15887566|NCT03746600|Behavioral|Project TRAC: Tracking and Reducing Alcohol Consumption|The TRAC intervention for people living with HIV/AIDS focuses on increasing motivation and building skills for avoiding triggers and managing situations that encourage alcohol consumption. It requires eight 30-minute sessions with a counselor using videoconferencing and mobile phones. In addition to receiving the eight sessions of intervention content, participants will complete smart phone-based self-monitoring of medication adherence and alcohol consumption, which will be discussed during intervention sessions.
15887567|NCT03746587|Drug|Arimoclomol|Arimoclomol in 3 different dosages
15887568|NCT03746587|Drug|Placebo oral capsule|Matching placebo capsule
15887569|NCT03746574|Behavioral|Compassion Curriculum|12 session curriculum offered every other week for six months. Each session lasted 80 minutes and all staff at the intervention clinics were expected to participate. A total of 16 hours of experiences were provided.
15887570|NCT03746561|Diagnostic Test|deep learning|detect and classify spinal stenosis by deep learning
15887571|NCT03746548|Device|Adhear|Patients are wearing the Adhesive bone conduction hearing device (Adhear) for 2 weeks
15887572|NCT03746548|Device|Contact Mini (CM)|Patients are wearing the Conventional bone conduction hearing device (Contact Mini) for 2 weeks
15887573|NCT03746535|Drug|Elagolix|Elagolix, 400 mg/day oral, 2X200 mg tablets/day for 4 days.
15887574|NCT03746522|Drug|Setmelanotide|Setmelanotide is a peptide that binds to the human MC4 receptor.
15887575|NCT03746522|Drug|Placebos|Matching placebo at equivalent volume to 3 mg setmelanotide.
15887576|NCT03746509|Device|Laryngeal Vibration (Treatment)|The strength of the vibration is similar to the vibration experienced from vibrating cell phones or gaming joysticks. Vibro-tactile stimulation at the applied frequency and amplitude is not known to cause pain or tissue damage. The participant may feel a mild tingling or vibrating sensation. Preliminary testing on healthy human subjects showed that at the given vibration parameters no adverse reactions occur.
15887577|NCT03746509|Device|Laryngeal Vibration (Comparator)|The strength of the vibration is similar to the vibration experienced from vibrating cell phones or gaming joysticks. Vibro-tactile stimulation at the applied frequency and amplitude is not known to cause pain or tissue damage. The participant may feel a mild tingling or vibrating sensation. Preliminary testing on healthy human subjects showed that at the given vibration parameters no adverse reactions occur.
15887578|NCT03746496|Diagnostic Test|point-of-care laboratory analysis|POC analysis with i-STAT POC analyser from the intraosseous and arterial blood
15887579|NCT03746483|Drug|MS1819-SD|MS1819-SD, an oral, non-systemic, that is non-enterically-coated. It is a yeast-derived (non-porcine) lipase pancreatic enzyme replacement.
15887580|NCT03746483|Drug|Porcine PERT|Porcine PERT is being used as a comparator to MS1819-SD as a second drug/intervention
15887581|NCT03746470|Procedure|ACL reconstruction preserving insertion|Anterior cruciate ligament reconstruction with semitendinosus and gracilis, preserving their insertion at the level of the hamstring.
15887582|NCT03746470|Procedure|ACL reconstruction detaching insertion|Anterior cruciate ligament reconstruction with semitendinosus and gracilis tendons completely detached from their insertion at the hamstring.
15887583|NCT03746457|Behavioral|Behavioral intervention|Individual counseling, group intervention, collective advocacy
15887584|NCT03746444|Other|General Anesthesia|The patients in general anesthesia group will undergo general anesthesia
15887585|NCT03746444|Other|Regional Anesthesia|The patients in Group R will be given combined spinoepidural anesthesia
15887586|NCT03746431|Drug|[111In]-FPI-1547 Injection|[111In]-FPI-1547 is a targeted radioimmuno-imaging agent that consists of FPI-1175, an insulin-like growth factor-1 receptor (IGF-1R)-targeting humanized monoclonal antibody, a bifunctional chelate, and Indium-111, a radionuclide. Patients will receive [111In]-FPI-1547 Injection of 185 MBq (5 mCi) for imaging.
15887587|NCT03746431|Drug|[225Ac]-FPI-1434 Injection multi-dose|[225Ac]-FPI-1434 is a targeted alpha radioimmuno-therapeutic agent that consists of FPI-1175, an insulin-like growth factor-1 receptor (IGF-1R)-targeting humanized monoclonal antibody, a bifunctional chelate, and Actinium-225, an alpha-emitting radionuclide. Patients will receive multiple doses of [225]-FPI-1434 Injection. Dose is per cohort assignment.
15887588|NCT03746431|Biological|FPI-1175 Infusion|FPI-1175 is an insulin-like growth factor-1 receptor (IGF-1R)-targeting humanized monoclonal antibody. Patients will receive FPI-1175 Infusion at a dose per cohort assignment.
15887589|NCT03746431|Drug|[225Ac]-FPI-1434 Injection single-dose|[225Ac]-FPI-1434 is a targeted alpha radioimmuno-therapeutic agent that consists of FPI-1175, an insulin-like growth factor-1 receptor (IGF-1R)-targeting humanized monoclonal antibody, a bifunctional chelate, and Actinium-225, an alpha-emitting radionuclide. Patients will receive a single dose of [225]-FPI-1434 Injection. Dose is per cohort assignment.
15887590|NCT03746418|Drug|Ultrasound Guided Bilateral single shot Erector Spinae Plane Block|Under aseptic technique and after skin infiltration with 3 ml of 2% lidocaine, a 22G, 50-mm, insulated facet type needle (visioplex® - vygon - France) was introduced in plane in a cephalad to caudad direction until (L3) transverse process was hit [figure1(A)(B)(C)] and the needle was slightly withdrawn. The confirmation of the correct position of the needle tip was done by injecting 0.5-1 ml of LA. Once confirmed, 20 ml of the drug was administered under vision after confirming negative aspiration of blood. LA distribution was observed in both cranial and caudal directions. This was repeated on the other side also. Twenty minutes later, sensory loss to cold was evident between (T10-T 12) and (L5-S1) vertebral level of the posterior dermatomes and dermatomes of the anterior roots of the spinal nerves (lumbar plexus, upper leg) on both sides without hemodynamic changes. Motor function of the legs was evaluated with a Bromage (0-3) score.
15887591|NCT03746405|Device|repetitive transcranial magnetic stimulation|excitatory 5Hz rTMS will be used
15887592|NCT03746405|Device|Sham repetitive transcranial magnetic stimulation|an electrical sham coil reproducing the same clicking sound and tactile sensation than the active rTMS will be used
15887630|NCT03746054|Combination Product|Optimal medical treatment|Life style modifications, Monitoring of the risk factors and Optimal medical treatment Lipid-lowering treatment, anti-platelet treatment and ACEi or AT2 antagonists treatment for a total duration of 24 months
15887631|NCT03746054|Combination Product|usual clinical practice|usual clinical practice in each center
15887632|NCT03746041|Drug|abaloparatide|In cycle 1, patients will be treated with single-agent, subcutaneous (SQ) abaloparatide at a dose of 80 mcg/day for 28 days.
15887751|NCT03745118|Device|GeneActiv|wearable seizure detection watch
15887593|NCT03746392|Behavioral|Jumpstart Intervention|"The intervention has 4 steps: use electronic medical record (EHR) to identify seriously ill, hospitalized patients with no documentation of a goals-of-care (GOC) discussion during their current admission; the enrolled patient or his/her surrogate completes a survey assessing preferences for discussions about GOC, barriers to having such discussions, and current GOC which is used to create a Jumpstart form designed to prompt and guide a GOC discussion between the patient or surrogate and the clinicians caring for the patient; use natural language processing/machine learning (NLP/ML) approach to identify GOC discussions or advance directives in the EHR that occurred prior to admission and include this information on the Jumpstart form; and, deliver the Jumpstart form to the primary clinician team. The patient or surrogate is also provided with a version of the form."
15887594|NCT03746366|Radiation|[C-11]|Radiolabel
15887595|NCT03746366|Drug|Pittsburgh Compound B|Tracer
15887596|NCT03746353|Procedure|early ileostomy closure|Assigned interventions Conventional closure of ileostomy: Surgical closure of the protective ileostomy 90 or more days after the proctectomy surgery
15887597|NCT03746340|Drug|Propofol|Propofol group: intravenous Propofol (2.0mg / kg) for general anesthesia induction, maintained for 30~60s. Continuous intravenous infusion of Propofol (7~8 mg·kg-1·h-1) with a syringe pump maintains a smooth general anesthetic sedative effect.
15887598|NCT03746340|Drug|Sevoflurane|Sevoflurane group: Inhalation of 1-8% sevoflurane for induction.Then Inhalation of sevoflurane (2.0~2.5Vol%) was maintained
15887599|NCT03746327|Drug|Sivextro 200 milligrams Oral Tablet|200 mg milligram per day during 4 weeks
15887601|NCT03746288|Drug|CAN008|CAN008 400 mg weekly over no less than 30 minutes via intravenous drip, followed by rRT that same day
15887602|NCT03746275|Drug|Rivaroxaban (BAY59-7939, Xarelto)|2.5 mg twice daily
15887603|NCT03746275|Drug|Acetylsalicylic acid|75 - 100 mg once daily according to local label
15887604|NCT03746249|Drug|Lenvatinib|12 mg (or 8 mg) once daily (QD) oral dosing.
15887605|NCT03746249|Drug|PD-1 antibody|3mg/kg intravenously every 2 weeks
15887606|NCT03746223|Drug|Methotrexate|400ug intravitreal injection every week for 4 doses in the induction phase, every 2 weeks for 2 doses as consolidation, then every month for 10 doses as maintenance
15887607|NCT03746223|Drug|Rituximab|Rituximab：375mg/m2 intravenous infusion d1, every 28 days for 1 cycle. 6 cycles will be prescribed as protocol
15887608|NCT03746223|Drug|Lenalidomide|25mg Qd, oral , d1-21 in 28-day cycle in the induction phase and maintenance phase.
15887609|NCT03746210|Diagnostic Test|Standard diagnostic procedures|B-Mode ultrasound, Duplex sonography, contrast-enhanced ultrasound, elastography, CT, MRI, anthropometrics
15887610|NCT03746197|Device|Project EVO Multi- Treatment|The EVO platform assesses perceptual discrimination while single-and multi-tasking. Visuomotor tracking involves navigating a character through a dynamically moving environment while avoiding obstacles. EVO uses adaptive algorithms to change game difficulty on a trial by trial and patient by patient basis for the tracking task and discrimination task with real-time feedback.
15887611|NCT03746184|Other|Treatment course|Pursued treatment for knee OA, including type of health care provider, time period of treatment course, and types of treatments received, will be recorded via the patient-reported questionnaire.
15887612|NCT03746171|Diagnostic Test|Colonic polyp characterization by BLI|"All rectosigmoid <5 mm polyps, regardless of the presence of larger polyps, will be characterized by BLI-assisted optical diagnosis by using BASIC criteria (neoplastic vs. non neoplastic) and will be included in polyp-level assessment.
~The polyp characterization will be always performed and recorded without zoom magnification. In patients in which colonoscopy will be performed with endoscopes equipped with zoom magnification, the zoom will be eventually systematically applied and the characterization with zoom will be also recorded. The post-polypectomy surveillance intervals based on BLI will be calculated by using histology estimation performed without zoom for all patients. Only polyps characterized with high confidence will be included in the analysis; the high-confidence characterization rate will be calculated."
15887613|NCT03746158|Dietary Supplement|curcumin|subjects will be assigned to consume one capsule of curcumin (330 mg of curcumin per capsule) three times a day (one capsule with each meal).
15887614|NCT03746145|Dietary Supplement|Bifidobacterium longum 1714|This is a double-blind randomized placebo-controlled pilot study. Participants under extreme conditions of hypoxia, confinement and isolation receive Bifidobacterium longum 1714 on a daily basis over one year in order to test improvements on stress resilience and immune functions.
15887615|NCT03746145|Dietary Supplement|placebo sachet containing maltodextrin and magnesium stearate.|placebo sachet containing maltodextrin and magnesium stearate.
15887616|NCT03746132|Device|EPIFLO|EPIFLO is a 3 ounce oxygen generator that continuously delivers 3 ml/hr of pure oxygen to the wound site, to enable tissue regenerative processes, thus driving closure of delayed-healing acute or chronic wounds.
15887617|NCT03746119|Other|E-cigarette vapor containing nicotine|A fourth generation e-cigarette device will be used with pre-determined temperature, voltage and wattage settings, and pre-mixed e-solution containing nicotine.
15887618|NCT03746119|Other|E-cigarette vapor, nicotine free|A fourth generation e-cigarette device will be used with pre-determined temperature, voltage and wattage settings, and pre-mixed nicotine free e-solution.
15887619|NCT03746106|Drug|Trimethoprim|300mg of trimethoprim will be given in combination with 5mg thiamine and compared to 5mg thiamine only for both Parts 1 and 2 of the study.
15887620|NCT03746106|Drug|Metformin|1000mg of metformin will be given in combination with 5mg thiamine and compared to 5mg thiamine only in Part 1 of the study.
15887621|NCT03746106|Dietary Supplement|Vitamin B1|5mg of thiamine will be given alone and in combination for both Parts 1 and 2 of the study.
15887622|NCT03746093|Dietary Supplement|Water|Participants will consume a bottle of water (330 ml) every day for 12 weeks.
15887623|NCT03746093|Dietary Supplement|Non-alcoholic beer|Participants will consume non-alcoholic beer (330 ml) every day for 12 weeks.
15887624|NCT03746080|Drug|Plerixafor|Plerixafor will be administered via infusion at 400 micrograms per kilogram per day for four weeks beginning one week before the end of radiation
15887625|NCT03746080|Drug|Temozolomide|Temozolomide (TMZ) will be administered concurrently with the radiation for 42 days and 6-12 cycles of monthly adjuvant Temozolomide (TMZ) after completion of Plerixafor infusion.
15887633|NCT03746041|Drug|bevacizumab|In cycles 2-4 (each cycle is 28 days), patients will be treated with SQ abaloparatide at a dose of 80 mcg/day and intravenous (IV) bevacizumab 5 mg/kg on days 1 and 15.
15887634|NCT03746015|Biological|Takeda's Tetravalent Dengue Vaccine Candidate (TDV)|Tetravalent Dengue Vaccine (TDV) subcutaneous injection
15887637|NCT03745989|Drug|MK-8353|Starting Dose (Dose Level [DL] 1): MK-8353
15887638|NCT03745989|Drug|Selumetinib|Starting Dose (Dose Level [DL] 1): selumetinib
15887639|NCT03745976|Procedure|questionnaire and Xray for all patients|questionnaire and Xray for all patients
15887640|NCT03745963|Behavioral|Skin-to-skin contact|Infants allocated to the SSC arm will be placed in upright, ventral SSC position (holding of a diaper clad baby on the bare chest of a mother) for a minimum of 15 minutes prior to data collection.
15887641|NCT03745963|Drug|24% oral sucrose|Administration of 24 percent oral sucrose will occur two minutes prior to the heel lance.
15887642|NCT03745950|Drug|Olaparib Oral Capsule|- Olaparib will be administrated by oral at dose of 300 mg twice daily during the induction period and in maintenance
15887643|NCT03745950|Drug|Placebo oral capsule|- Placebo will be administrated by oral at dose of 300 mg twice daily during the induction period and in maintenance
15887644|NCT03745937|Drug|MEDI0382|Subcutaneous dose of MEDI0382 will be up-titrated weekly once daily up to 8 weeks during the uptitration period and thereafter once daily in 3-week TEP.
15887645|NCT03745937|Drug|Placebo|Subcutaneous dose of placebo matched to MEDI0382 will be administered once daily up to 8 weeks during the up-titration period and thereafter once daily through 3 week TEP.
15887647|NCT03745911|Combination Product|Paclitaxel and TAK-228|Treatment with TAK-228 oral (D2, 3 and 4 of each week) and paclitaxel (D1 of each week) on Days 1, 8 and 15 for each 28-days cycle until disease progression or unacceptable toxicity. If paclitaxel is stopped, TAK-228 may be continued
15887648|NCT03745898|Drug|Oxygen|Active nocturnal oxygen concentrator
15887649|NCT03745898|Other|Room Air|Sham nocturnal oxygen concentrator (room air)
15887650|NCT03745885|Drug|Supaglutide injection|Administered SC in the Supaglutide arms.
15887651|NCT03745885|Drug|Placebo|Administered SC in the placebo arms and to maintain the blind in the Supaglutide injection arms.
15887652|NCT03745872|Behavioral|Knowledge Assessment|Students participating in this study will receive a pre test, instruction regarding sun safety, and a post test.
15887653|NCT03745859|Device|Fraxinus VBN system|Open source planning tool for bronchoscopy
15887654|NCT03745846|Biological|Composite Gel Containing Black Raspberry|Composite Gel Containing Black Raspberry 3,000/preparation
15887655|NCT03745846|Biological|placebo|Composite Gel Containing Black Raspberry-placebo
15887656|NCT03745833|Device|Virtual Reality Mindfulness|Participating patients will be provided with a VR headset (pre-programmed with mindfulness content) after lunch for 15 minutes with supervision while on strict bedrest. The headset will be collected following the intervention. Patients are currently provided with a post-meal survey following all meals as part of the standard of care, and will complete the survey following the lunchtime intervention.
15887657|NCT03745820|Drug|BIIB104|Administered as specified in the treatment arm
15887658|NCT03745820|Other|Placebo|Administered as specified in the treatment arm
15887659|NCT03745807|Biological|NKTR-214|Specified dose on specified days
15887660|NCT03745807|Biological|Nivolumab|Specified dose on specified days
15887661|NCT03745794|Other|Best Practice|Given standard of care
15887662|NCT03745794|Drug|Quadratus Lumborum Block|Undergo QL block
15887663|NCT03745794|Other|Quality-of-Life Assessment|Ancillary studies
15887664|NCT03745794|Other|Questionnaire Administration|Ancillary studies
15887665|NCT03745781|Drug|Placebos|placebo pills
15887666|NCT03745768|Device|Intermittent Theta Burst Stimulation|Intermittent theta burst stimulation delivered to the dorsolateral prefrontal cortex on the left and right sides of the brain.
15887667|NCT03745742|Other|HRV measurement|"Patients in group A (control) will benefit from a standard re-training protocol based on initial functional abilities. The training is done at a target heart rate corresponding to the heart rate reached at the first ventilatory threshold (about 55% of VO2max).
~Patients in group B (study strategy) will benefit from a re-training protocol based on HRV and initial functional abilities. Any increase in HRV compared to the previous day will result in an increase in workload of 10Watt. Any increase or decrease in HRV for 3 days in a row will cause the stagnation of the workload for 2 days.
~HRV is measured every day in each group via a heart rate belt and a smartphone App."
15887668|NCT03745729|Drug|allopurinol sustained-release capsules|allopurinol sustained-release capsules (0.3g), once a day, one pill at a time
15887669|NCT03745729|Drug|placebo capsules|placebo sustained-release capsules, once a day, one pill at a time
15887670|NCT03745716|Drug|APR-246 + azacitidine|"Patients will be randomized (1:1) to one of two arms: stratified by age (< 65 years versus ≥ 65):
~Experimental arm: APR-246 + azacitidine; or Control arm: Azacitidine"
15887671|NCT03745716|Drug|Azacitidine|"Patients will be randomized (1:1) to one of two arms: stratified by age (< 65 years versus ≥ 65):
~Experimental arm: APR-246 + azacitidine; or Control arm: Azacitidine"
15887672|NCT03745703|Behavioral|MOCHA|(see above)
15887673|NCT03745690|Procedure|Image-Guided Surgery|Undergo near-infrared image guided surgical resection
15887674|NCT03745690|Drug|Indocyanine Green Drug|Given IV
15887675|NCT03745677|Behavioral|Advanced and Integrated MicroSystems (AIMS) interventions|Each of 4 sites is receiving mentorship from nurse and physician with expertise in implementing similar interventions. The AIMS interventions consist of 1) unit-based physician teams, 2) unit nurse-physician co-leadership, 3) enhanced interprofessional rounds, 4) unit-level performance reports, and 5) patient engagement activities.
15887676|NCT03745664|Drug|Methylprednisolone Sodium Succinate|During hospitalization, 40 mg of methylprednisolone (20 mg/ml) will be given intravenously twice a day (20 mg every 12 hours).
15887677|NCT03745664|Drug|Saline Solution for Injection|During hospitalization, 2 ml of Saline Solution for Injection will be given intravenously twice a day (2 ml every 12 hours).
15887678|NCT03745651|Drug|Ruxolitinib cream|Ruxolitinib cream 1.5% or 0.75% applied as a thin film twice daily (BID) (vehicle-controlled (VC) and long-term safety extension periods).
15887679|NCT03745651|Drug|Vehicle cream|Matching vehicle cream applied as a thin film BID (VC period only).
15887680|NCT03745638|Drug|Ruxolitinib cream|Ruxolitinib cream 1.5% or 0.75% applied as a thin film twice daily (BID) (vehicle-controlled (VC) and long-term safety extension periods).
15887681|NCT03745638|Drug|Vehicle cream|Matching vehicle cream applied as a thin film BID (VC period only).
15887682|NCT03745625|Drug|HSK3486|"First-stage:after an initial dose of 1mg/kg/h, If the BIS is in the range of 80 to 60 and the continuous RASS score = 3 or one time RASS score ≤ -4, the 0.4 mg/kg/h maintenance dose is administered. The total infusion time was 4h.
~Second-stage: a single loading dose of 0.2 mg/kg given over 1 minute, then a continuous infusion of maintenance dose 0.35 mg/kg/h for a total infusion time of 12h."
15887683|NCT03745625|Drug|Propofol|"First-stage: after an initial dose of 5mg/kg/h, If the BIS is in the range of 80 to 60 and the continuous RASS score = 3 or one time RASS score ≤ -4, the 0.4 mg/kg/h maintenance dose is administered. The total infusion time was 4h.
~Second-stage: loading dose of 1mg/kg given over 1 minute, then a continuous infusion of maintenance dose 1.75 mg/kg/h for a total infusion time of 12h."
15887684|NCT03745612|Behavioral|Time restricted feeding|Participants will receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women during a window of 8 h/d (8 am to 4 pm).
15887685|NCT03745612|Behavioral|Continuous Energy Restriction|Participants will follow receive a diet of 1500-1800kcal/d for men and 1200-1500kcal/d for women, without a restriction of feeding time.
15887686|NCT03745599|Drug|Diclofenac|All patients were instructed to take one capsule orally every 8 h and apply the spray (4 puffs to the pericoronitis area) every 4 h for 7 days, commencing immediately after the clinical examination.
15887687|NCT03745599|Drug|Flurbiprofen|All patients were instructed to take one capsule orally every 8 h and apply the spray (4 puffs to the pericoronitis area) every 4 h for 7 days, commencing immediately after the clinical examination.
15887688|NCT03745599|Drug|Benzydamine|All patients were instructed to take one capsule orally every 8 h and apply the spray (4 puffs to the pericoronitis area) every 4 h for 7 days, commencing immediately after the clinical examination.
15887689|NCT03745586|Drug|Tocilizumab|Day 3: Tocilizumab infusion (8mg/kg body-weight) Day 10- week 52: Tocilizumab s.c. injections (162mg) in weekly intervals
15887690|NCT03745586|Drug|Glucocorticoids|Day0-day2: methylprednisolone 500mg i.v.
15887691|NCT03745573|Behavioral|Empateach|Empateach is a behavioural intervention for teachers.
15887692|NCT03745547|Other|Adherence to wearing a Spire wearable health monitor|Participants will wear a Spire health monitor every day for 9 months and receive weekly emails with a short survey about the participant's condition and symptoms. If participants fail to respond to this email or Spire detects that a participant is not wearing the monitor, participants will be contacted by a nurse. While participants are wearing the monitor, Spire will make sure the sensors are collecting data but will not review the data in real time. If a participant's monitor stops sending data to Spire for more than 24 hours, the participant will be contacted. If the participant is unreachable for 10 days the participant's emergency contact will be contacted. If neither the participant nor the emergency contact is reachable over 24 days the participant will be removed from the study.
15887693|NCT03745534|Other|eABR|eABR
15887694|NCT03745521|Other|no intervention|no intervention
15887695|NCT03745508|Other|Instant Coffee|Instant coffee prepared at different caffeine concentrations
15887696|NCT03745482|Other|Lumbar Mobilisations|The intervention will consist of unilateral lumbar mobilisations at the L4 and L5 level in a Posterior Anterior direction. The side of the mobilisation will be determined by dominant leg - considered the kicking foot. The mobilisations will be administered by a physiotherapist with at least 10 years clinical experience. Teksan grip sensors will be worn by the physiotherapist to calculate the force applied to the participant. Grade three mobilisations will be applied for a one minute period three times at both L4 and L5 level. Each level will be determined by a passive physiological intervertebral movement. Participants will receive the mobilisations at L5 first for one minute followed by L4. This is an appropriate dose for mobilisation application (Maitland, 2013). This process will be carried out three times.
15887697|NCT03745469|Device|Smartphone|A standard smartphone will be used for browsing the internet for two different durations (10 and 30 minutes)
15887698|NCT03745456|Diagnostic Test|Blood samples for ROTEM and platelet function.|Thormoboelastometry is based on the measurement of elasticity of blood by continuous graphical logging of the firmness of a blood clot during clot formation and subsequent fibrinolysis
15887699|NCT03745443|Procedure|increase and decrease positive end-expiratory pressure|20 minutes before the end of anesthesia and surgery PEEP was increased by 2 on every 5 breaths to 11. Ventilation with PEEP 11 was maintained for 2 minutes. Then, PEEP was reduced by 2 on every 5 breaths to 5 cmH2O
15887701|NCT03745417|Biological|Umbilical cord mesenchymal stem cells|Umbilical cord mesenchymal stem cells were infused intravenously at a dose of 2 million cells/kg.
15887702|NCT03745404|Drug|Lidocaine 5% medicated Plaster|
15887703|NCT03745404|Drug|Placebo Plaster|
15887704|NCT03745391|Diagnostic Test|MULTIMODAL MAGNETIC RESONANCE (Multimodal MR)|After randomization, a MULTIMODAL MR will be performed to select treatment patient
15887705|NCT03745391|Diagnostic Test|MULTIMODAL COMPUTERIZED TOMOGRAPHY (Multimodal CT)|After randomization, a MULTIMODAL CT will be performed to select treatment patient
15887746|NCT03745131|Other|Blood draw|Blood draw to obtain serum to determine anti-orthopox antibody titres.
15890026|NCT03727061|Procedure|Interstitial Illumination Photodynamic Therapy|Undergo I-PDT
15887706|NCT03745378|Other|JAK2V617F mutation|JAK2 V617F is attached to the cytosolic juxtamembrane region of dimeric cytokine receptors, such as EpoR or MPL (TpoR); The JAK2V617F mutation results from a guanine to thymine change at nucleotide 1849 of the cDNA, in exon 14 of the gene. This valine is located at one of the predicted interfaces between JH1 and JH2 domains,
15887707|NCT03745365|Procedure|loop bipartition|A loop gastro-ileostomy 250-300 cm from the ileocecal valve or 200-250 cm from duodeno-jejunal junction was created at the dependent part of the antrum with 2 layers of handsewn suture but without division of the 1st part of duodenum. The resultant stomach tube has two outlets, one to the first part of duodenum through the pylorus and one to the terminal ileum through the gastroileostomy.
15887708|NCT03745352|Drug|Azacitidine|Given IV or SC
15887709|NCT03745352|Drug|Pevonedistat|Given IV
15887710|NCT03745326|Drug|Cyclophosphamide|Days -7 and -6: Cyclophosphamide 60 mg/kg/day x 2 days IV in 250 mL D5W infused simultaneously with mesna 15 mg/kg/day over 1 hour x 2 days.
15887711|NCT03745326|Drug|Fludarabine|Days -7 to -3: Fludarabine 25 mg /m^2/day IVPB daily over 30 minutes for 5 days.
15887712|NCT03745326|Drug|Aldesleukin|Aldesleukin 720,000 IU/kg (based on total body weight) IV over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 3 days (maximum 9 doses).
15887713|NCT03745326|Biological|anti-KRAS G12D mTCR PBL|Day 0: Cells will be infused intravenously on the Patient Care Unit over 20-30 minutes. (2-4 days after the last dose of fludarabine).
15887714|NCT03745313|Device|Transcatheter Tricuspid Valve Repair|Repair of the tricuspid valve through a transcatheter approach
15887715|NCT03745300|Drug|ATORVASTATIN|Scaling and Root Planing (SRP) followed by placement of atorvastatin gel
15887716|NCT03745300|Drug|SIMVASTATIN|Scaling and Root Planing (SRP) followed by placement of simvastatin gel
15887717|NCT03745300|Drug|PLACEBO|Scaling and Root Planing (SRP) followed by placement of placebo gel
15887718|NCT03745287|Biological|CTX001|Administered by IV infusion following myeloablative conditioning with busulfan.
15887719|NCT03745274|Biological|GHB04L1|Solution
15887720|NCT03745274|Other|Placebo|Buffer solution
15887721|NCT03745261|Drug|Salbutamol (Ventolin®)|According to the revised 2017 GOLD, patients will be divided into Group A, B, C, and D based on individualized assessment. Salbutamol will be used to Group A patients: Salbutamol (Ventolin®, GlaxoSmithKline) 100μg/dose. 100 μg each time (when needed), and the maximum dose is 8-12 inhalations a day.
15887722|NCT03745261|Drug|Tiotropium Bromide (Spiriva®)|Tiotropium Bromide Powder for Inhalation will be used to Group B and Group C patients: Tiotropium Bromide Powder for Inhalation(Spiriva®, Boehringer Ingelheim), 18μg/ capsule, 10 capsules. 18μg each time, once daily.
15887723|NCT03745261|Drug|Salmeterol / fluticasone (Seretide®)|Salmeterol / fluticasone will be used to Group D patients: Salmeterol / fluticasone (Seretide®, GlaxoSmithKline), 50/250 μg / dose, 60 inhalations. 50/250 μg each time, twice daily.
15887724|NCT03745261|Drug|YCC capsule|According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi of the lung and kidney will be given Yong Chong Cao (YCC)capsule (Kecai®, Guangdong daguang pharmaceutical group Co., Ltd), 1 g each time, three times a day.
15887725|NCT03745261|Drug|BL capsule|According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi of the lung and kidney will be given Bailing(BL) capsule (Bailing®, Huadong Medicine Co.,Ltd), 1 g each time, three times a day
15887726|NCT03745248|Behavioral|Aerobic training|Aerobic training on stationary bicycle for 30 minutes a day, 5 days a week for 1 month
15887727|NCT03745248|Behavioral|Balance Training|Standard of care
15887728|NCT03745235|Other|stress reduction program based on mindfulness|a two and a half hour session per week for 8 weeks
15887729|NCT03745235|Biological|venipunctures|1 dry tube of 5 ml and 5 heparinized tubes of 6 ml taken at inclusion, at 3 months and at 12 months
15887730|NCT03745235|Other|psychometric questionnaires|"Cohen PSS' perceived stress scale
~Beck's anxiety and depression questionnaires
~Watson's affectivity questionnaire, positive affect and negative affect schedule
~optimism questionnaire, Life Orientation Test LOT-R by Sheier and Carver
~IN-OUT DASQ dispositional affective style questionnaire"
15887731|NCT03745222|Drug|Tislelizumab|PD-1 inhibitor (monoclonal antibody against PD-1)
15887732|NCT03745222|Drug|Concurrent chemoradiotherapy (cCRT)|Chemotherapy options include carboplatin/paclitaxel and cisplatin/etoposide per standard of care. Radiotherapy will also be given concurrently with chemotherapy.
15887733|NCT03745222|Other|Placebo|Placebo
15887734|NCT03745209|Device|Ultrasound|Use of real-time ultrasound in an attempt to establish intravenous peripheral catheter.
15887735|NCT03745196|Drug|PC945|Study drug under investigation
15887736|NCT03745196|Drug|Placebo|Placebo control
15887737|NCT03745183|Other|Senna alata leaf decoction|"Preparation of the akapulko decoction
~Remove the leaflets from the rachis of a mature leaf.
~Wash the mature leaflets thoroughly to remove dust, dirt and debris.
~In the clay, enamel, or stainless steel pot, place one glassful of closely packed chopped leaves (350 ml glass) and add 2 glasses (around 700ml) of clean water . Use the same glass for measuring the leaves and water.
~Cook the leaves and bring to a rolling boil.
~When the fluid is reduced to half, remove the decoction from the fire and cool slightly.
~Strain the mixture using cheesecloth and press the cut leaves in the strainer to make sure to get as much liquid out of them.
~Place the liquid in a clean container (bottle/jar with cover). Label the container clearly as Akapulko."
15887738|NCT03745170|Drug|Sintilimab|Weight<60Kg: 3mg/kg Q3W Weignt>=60Kg:200 mg Q3W on Day 1 by IV infusion
15887739|NCT03745170|Drug|Oxaliplatin|130 mg/m^2 Q3W on Day 1 by IV infusion
15887740|NCT03745170|Drug|Capecitabine|1000 mg/m^2 orally according to Body Surface Area (BSA) BID Q3W on Days 1-14
15887741|NCT03745170|Drug|placebo|Weight<60Kg: 3mg/kg Q3W Weignt>=60Kg:200 mg Q3W on Day 1 by IV infusion
15887742|NCT03745157|Drug|Insulin Degludec/Insulin Aspart|Patients will be treated with commercially available Insulin Degludec/Insulin Aspart (Ryzodeg®) in a pre-filled pen injector (FlexTouch®) according to routine clinical practice at the discretion of the treating physician in accordance with the Ryzodeg® label in Japan
15887752|NCT03745105|Drug|Dexamethasone sodium phosphate|prophylactic intraligamentary supplemental injection of 0.4 ml of 8 mg/2 mL dexamethasone.
15887753|NCT03745105|Drug|Piroxicam Injectable Solution|prophylactic intraligamentary supplemental injection of 0.4 mL of 20 mg mL-1 piroxicam
15887754|NCT03745105|Drug|Mepivacaine HCL|prophylactic intraligamentary supplemental injection 0.4 mL of Mepivacaine HCl 36 mg /1.8 ml + Levonordefrin HCl 0.108 mg/ 1.8 ml
15887755|NCT03745092|Device|normobaric oxygen|Normobaric oxygen (NBO) is a routine adjuvant hyperoxygenation intervention supplied by facemask (such as Venturi mask), with one atmosphere pressure (1ATA=101.325kPa).
15887756|NCT03745092|Device|room air|The patient had a rest with lying, sitting or walking, did not performed with NBO intervention.
15887757|NCT03745079|Other|Esophagus temperature monitoring|Measuring core temperature by esophageal stethoscope
15887758|NCT03745079|Other|Spoton Temporal|Mesuring temperature on skin near to temporal artery using Spoton
15887759|NCT03745079|Other|Spoton Carotid|Mesuring temperature on skin near to carotidl artery using Spoton
15887760|NCT03745053|Device|Xlimus DES Implantation during coronary angioplasty|Xlimus DES Implantation during coronary angioplasty
15887761|NCT03745053|Device|Synergy DES Implantation during coronary angioplasty|Synergy DES Implantation during coronary angioplasty
15887762|NCT03745040|Drug|Liposomal bupivacaine|20ml bupivacaine liposome injectable suspension 1.3% (266mg) + 50ml 0.25% Bupivacaine (150mg) + 70ml preservative-free 0.9% neutral saline
15887763|NCT03745027|Diagnostic Test|in vitro fertilization|All patients underwent gonadotropin-releasing hormone agonist (GnRHa) treatment for in vitro fertilization and Follicular fluid sialic acid levels are measured.
15887764|NCT03745014|Diagnostic Test|Accelerate Pheno|The Accelerate Pheno™ system and PhenoTest™ BC Kit is a fully-integrated in vitro diagnostic system. It is FDA-cleared to perform ID of bacteria and yeast in less than 90 minutes and AST in less than 7 hours, on average, directly from positive blood culture.
15887765|NCT03745014|Diagnostic Test|Standard of Care|Standard blood culture work up as determined by the site's microbiology lab.
15887766|NCT03745001|Drug|EHP-101 Liquid single dose|One single oral administration with EHP-101 liquid formulation. The doses will be ascending per cohort from 0.91 mg to 200 mg. The initially planned once daily dose regimen may be modified by the Safety Review Committee based on emerging PK data, eg, assigned dose levels may be divided into 2 doses administered 12 hours apart (twice a day).
15887767|NCT03745001|Drug|EHP-101 Liquid multiple doses|One single daily administration with EHP-101 liquid formulation during 7 consecutive days. The doses will be ascending per cohort. Each ascending level will not exceed the tested dose levels in the single dose part of the study. The initially planned once daily dose regimen may be modified by the Safety Review Committee based on emerging PK data, eg, assigned dose levels may be divided into 2 doses administered 12 hours apart (twice a day)
15887768|NCT03745001|Drug|Matching placebo|Oral liquid administration daily
15887769|NCT03744988|Diagnostic Test|serum androgen levels|measurement of serum free and total testosterone
15887770|NCT03744975|Drug|LCZ 696|Participants will receive Oral LCZ 696 (Entresto 97/103 mg)
15887771|NCT03744975|Drug|Placebos|Participants will receive 1oral Placebo capsule
15887772|NCT03744949|Drug|Remifentanil dose 0.5 ug/kg|Remifentanil will be given (dosage of 0.5 µg/kg of adjusted body weight bolus) from an infusion pump over 30 seconds
15887773|NCT03744949|Drug|Remifentanil dose 1 ug/kg|Remifentanil will be given (dosage of 1 µg/kg of adjusted body weight bolus) from an infusion pump over 30 seconds
15887774|NCT03744949|Drug|Remifentanil dose 1.5 ug/kg|Remifentanil will be given (dosage of 1.5 µg/kg of adjusted body weight bolus) from an infusion pump over 30 seconds
15887775|NCT03744949|Drug|Remifentanil dose 2 ug/kg|Remifentanil will be given (dosage of 2 µg/kg of adjusted body weight bolus) from an infusion pump over 30 seconds
15887776|NCT03744936|Other|DA4Afib Prototyping|We will develop a prototype from patients with atrial fibrillation
15887777|NCT03744923|Procedure|transmuscular QL block|"Ultrasound device will be used; The probe is placed in the mid-axillary line cranially to the iliac crest to identify the three muscles of the anterior abdominal wall. Then, scan dorsally keeping the transverse orientation until observing that the transversusabdominus muscle becomes aponeurotic, and this aponeurosis is followed until the QL muscle is clearly visualized with its attachment to the lateral edge of the transverse process of the L2 vertebral body and visualize the thoracolumbar fascia at the lateral edge of the QL muscle.
~The view of the psoas major muscle (PM) anteriorly, the erector spinae muscle (ESM) posteriorly and the QL muscle adherent to the apex of the transverse process result in a well recognizable pattern of a Shamrock with three leaves (trifoliate)."
15887778|NCT03744923|Procedure|Transversus Abdominus Plane block|"Posterior TAP block will be performed on the same side of surgery (unilateral) under ultrasonographic guidance with a with broadband (7-13MHz) linear probe covered with a sterile plastic sheath. Probe will positioned transversely midway between the iliac crest and the costal margin at level of mid axillary line.
~Once the external oblique muscle (EOM), internal oblique muscle (IOM) and transversus abdominis muscle (TAM) are visualized at the level of the mid axillary line between the 12th rib and the iliac crest, the puncture area and the ultrasound probe were prepared in a sterile manner. After identification of the neuro-facial plane between IOM and TAM, block was performed with 20G spinal needle. The needle will be directed to approach the TAP with in-plane USG-guided technique. Once the tip of the needle placed in the space between the IOM and TAM, Inject a 1 ml test dose of lidocaine 2% for hydrovisualization of needle-tip position and confirming its correct postioning."
15887779|NCT03744910|Biological|Clazakizumab|Clazakizumab is a genetically engineered humanized immunoglobulin G1 (IgG1) mAb that binds to human IL-6
15887780|NCT03744910|Drug|Physiologic saline solution|Normal saline
15887781|NCT03744897|Behavioral|Hypnotic analgesia|Subjects will receive hypnotic analgesia during 20 minutes
15887782|NCT03744897|Device|a-tDCS|Subjects will receive transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 2mA, 20 minutes
15887783|NCT03744897|Other|Hypnotic analgesia + a-tDCS|Subjects will receive hypnotic analgesia associated to transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 2mA, 20 minutes
15887784|NCT03744897|Device|s-tDCS|Subjects will receive sham transcranial direct stimulation over bilateral DLPFC left/anode right/cathodal, 0mA, 20 minutes
15887907|NCT03743818|Device|dry needling|dry needling on the trigger point of the vastus medialis of the quadriceps
15887785|NCT03744884|Behavioral|Force efforts with haptic feedback in virtual reality.|A virtual reality game-based intervention incorporating fully-automated robotic haptic feedback. The study consists of face-to-face assessments of movement before, after, and one-month following the completion of the six-session game-based intervention. Children with spastic/dystonic cerebral palsy between the ages of 7 and 17 will be recruited for this study along with a group of typically developing children in the same age range. Both groups of children will be randomly allocated into an intervention or control group using a blocked randomization method.
15887786|NCT03744871|Other|N95 Respirator|SiTi N95 respirator with microventilator (change twice weekly and earlier as needed).
15887787|NCT03744858|Procedure|Peripheral blood draw|Peripheral vein blood draw will be performed to all participants in order to collect blood samples to be evaluated.
15887788|NCT03744845|Other|Virtual Reality Distraction|This RCT will utilize an Oculus Go VR headset that delivers VR images and sound. Users will wear the VR headset. A research coordinator will familiarize patients with hardware before use. The VR will be used preoperatively and intraoperatively to distracts patients, and aid with the treatment of pain and anxiety.
15887789|NCT03744832|Diagnostic Test|Alere i™ Strep A assay|Point of care (POC) molecular-based, nucleic acid amplification test (NAAT). This isothermal molecular assay is CLIA waived (Clinical Laboratory Improvement Amendments) and Health Canada licensed for POC use, and is anticipated to have approval for use without need for back up culture testing.
15887790|NCT03744832|Diagnostic Test|Throat culture|Standard bacterial throat culture.
15887791|NCT03744806|Drug|Bevacizumab Injection|
15887792|NCT03744793|Drug|Avelumab|Given IV
15887793|NCT03744793|Drug|Pemetrexed|Given IV
15887794|NCT03744780|Behavioral|ACT Workshop for Emotional Eating|"This is a one-day intervention using Acceptance and Commitment Therapy (ACT) technique to target and reduce emotional eating. The intervention will be modeled after Frayn and Knäuper's (2016) brief emotional eating intervention, which was derived from Forman et al.'s (2013) Mind Your Health program. During the workshop, the following topics will be discussed, based on the three processes of ACT: (1) values clarification/commitment, (2) acceptance/distress tolerance, and (3) mindfulness/awareness."
15887795|NCT03744767|Drug|Spironolactone 50 MG|oral administration of Spironolactone, 25mg daily for 1 week, then 50mg daily until visit Month 3, followed by 25mg daily from visit Month 3 to visit Month 4
15887796|NCT03744741|Diagnostic Test|HostDx Sepsis|Blood collection for mRNA analysis, Procalcitonin and CRP determination, molecular analysis of nasopharyngeal swab collection
15887797|NCT03744728|Diagnostic Test|Accelerate PhenoTest™ BC kit|The Accelerate PhenoTest™ BC kit with the Accelerate Pheno™ System is a fully-integrated in vitro diagnostic system. It is FDA-cleared to perform ID of bacteria and yeast in less than 90 minutes and AST in less than 7 hours, on average, directly from positive blood culture
15887798|NCT03744728|Diagnostic Test|Standard of Care|Standard culture and AST of positive blood culture bottles plus the Verigene® BC-GP/GN
15887799|NCT03744715|Drug|Poziotinib|Poziotinib will be taken by the patient orally, once daily with food and a glass of water at approximately the same time. The dose will be the last dose received or at the standard starting dose of 16 mg poziotinib. If a dose is missed, it may be taken any time during the day preferably with food, but at least 8 hours prior to the next scheduled dose.
15887800|NCT03744702|Drug|Ascorbic Acid|Patients will receive IV ascorbic acid.
15887801|NCT03744689|Procedure|Erector Spinae Plane block|Erector Spinae plane block will be done according to hernia level using bupivacaine hydrochloride
15887802|NCT03744689|Procedure|Sham block|Sham block will be done with serum physiologic.
15887803|NCT03744689|Drug|Bupivacaine Hydrochloride|20 ml 0,25% Bupivacaine will be used for block performances
15887804|NCT03744689|Device|PCA|Intravenous morphine patient controlled analgesia device will be given to the patients postoperatively and 24 hour morphine consumption will be recorded
15887805|NCT03744676|Biological|lisocabtagene maraleucel|lisocabtagene maraleucel will be administered as single dose intravenous (IV) injection
15887806|NCT03744663|Drug|Suboxone® SL|Subjects will be started and titrated to optimal Suboxone® SL dose for 14 days. After the 14 day induction phase, the subject will be started on the treatment to which they were randomized to two groups one of which will be Suboxone® SL.
15887807|NCT03744663|Drug|Sublocade®|Subjects will be started and titrated to optimal Suboxone® SL dose for 14 days. After the 14 day induction phase, the subject will be started on the treatment to which they were randomized, either Suboxone® SL or Sublocade®. Subjects with significant opioid craving (> 20 mm on the Opioid Craving Visual Analog Scale) or withdrawal (a score of > 12 on the Clinical Opiate Withdrawal Scale) after 14 days of treatment will be started on Sublocade® only at the consensus of the research team. Otherwise they will undergo an additional 7 day titration period. Study drug with Sublocade® group: Patients assigned to this group will receive the study drug (300 mg subcutaneously) every 4 weeks for a total of 6 doses along with weekly therapy. The location and specifications of its application will follow the recommendations by the FDA previously published.
15887808|NCT03744650|Behavioral|"Care4Heart programme"|"A 4-week mHealth programme in the form of a smartphone app, named Care4Heart, has been developed. The content and scope of the design are developed by a thorough literature review and an extensive analysis of existing education leaflets and brochures used to prevent CHD. The contents are specified and tailored to the working population.
~The app is developed by a team of software engineers from Computing School of NUS. Several functions include: (1) app using instructional video; (2) easy-to-read information on healthy lifestyle toward heart health, including information about the disease, CHD risk factors (e.g. diet, smoking cessation), stress, physical exercises and relaxation techniques; and (3) scheduled reminders for doing exercise and relaxation"
15887809|NCT03744637|Drug|MK-5475|Single inhaled dose of MK-5475 120, 165, 240, 300 , 360 or 480 µg
15887810|NCT03744637|Drug|Placebo|Single inhaled dose of placebo to match MK-5475
15887811|NCT03744624|Procedure|Laparoscopic liver resection|Laparoscopic liver resection for oncological purposes
15887812|NCT03744624|Device|3D printing model|Use of 3D printed liver model in decision-making: preoperative planning and intraoperative guidance.
15887813|NCT03744611|Dietary Supplement|CE|550mg capsule (Eucommia ulmoides Oliver extract)
15887814|NCT03744611|Dietary Supplement|Placebo|550mg capsule (Placebo)
15887908|NCT03743818|Other|ultrasound|aply ultrasound on the knee
15887909|NCT03743818|Device|hyauluronic acid|aply hyaluronic acid on the knee
15887815|NCT03744559|Behavioral|Retrieval Extinction Training (RET)|Retrieval extinction training (RET) is a behavioral intervention that involves cue-elicited retrieval followed by extinction training (i.e., massed unreinforced exposure to drug-associated cues). The first element of RET involves briefly presenting drug-associated cues to retrieve drug use memories. The second element, occurring after a brief interval, involves extinction training. It is argued that the initial retrieval of the memories prior to extinction training initiates a period of instability, which is followed by reconsolidation of the memories back into long-term storage. Extinction training during the period of instability is presumed to overwrite the original drug-associated cue with a non-drug-associated cue, to attenuate expression of drug-seeking behavior.
15887816|NCT03744559|Behavioral|Control Retrieval Extinction Training (RET)|The control retrieval extinction training (RET) for the NR-E arms serves as the control intervention to the RET behavioral intervention. The first element of the control RET involves briefly presenting retrieval cues that contain neutral, non-smoking content. The second element, occurring after a brief interval, involves extinction training. Based on findings from the previous NIDA-funded R21, the R-E arm reported a significant 25 percent reduction in cigarettes smoked per day during the follow-up period versus the control NR-E arm.
15887817|NCT03744559|Other|Functional magnetic resonance imaging (fMRI)|Functional magnetic resonance imaging (fMRI) will identify patterns of brain activity associated with RET and potentially predictive of treatment outcomes. The fMRI is used during the baseline and 24-hour follow-up test sessions while participants complete a cue-reactivity task. The collection of fMRI data is based on findings from human fear conditioning fMRI studies, in which groups receiving RET in the reconsolidation window exhibited less fear that was associated with attenuated BOLD response in the amygdala, relative to the control. We propose that the R-E arm will evidence attenuated cue reactivity in medial prefrontal cortex, limbic regions and ventral striatum, and that greater reduction in BOLD response in regions of interest will predict decreased smoking.
15887818|NCT03744559|Other|No functional magnetic resonance imaging (fMRI)|No functional magnetic resonance imaging (fMRI) serves as the control intervention to the fMRI intervention. Participants who are randomized to the no fMRI intervention or who have a contraindication to MRI will complete an identical cue-reactivity task in a cue-reactivity lab during the baseline and 24-hour follow-up test sessions.
15887819|NCT03744546|Drug|ABBV-8E12|Solution for infusion
15887820|NCT03744533|Other|head-down position treatment|the head position of subjects is lowered to 20 degrees in a supine position between 8:00-22:00 within 24h post-randomization as long as possible. During the procedure, when subjects feel intolerable, the head position will be elevated to lying flat (0 degree) for 5-10min, and then the above procedure is repeated. After 24h post-randomization, the head down procedures with -20 degrees in a supine position with duration of 1-1.5 hour will be performed three times daily at 9:00-11:00, 15:00-17:00 and 20:00-22:00, respectively.
15887821|NCT03744533|Other|guideline-based treatment|guideline-based treatment
15887822|NCT03744520|Procedure|Erector spinae plane block|Local anesthetic infiltration is applied between the erector spinae muscle fascia and transverse process.
15887823|NCT03744494|Procedure|Bilateral simple orchidectomy (BSO)|
15887824|NCT03744494|Procedure|Bilateral Subcapsular Orchidectomy|
15887825|NCT03744494|Procedure|Bilateral Epididymal-sparing Orchidectomy|
15887826|NCT03744481|Other|Questionaire|"Evaluation of psychomotor development in children with mild EAI without indication of therapeutic hypothermia.
~Precise analysis of the type (motor, sensory, language, epilepsy) and the severity of sequelae by sending a questionnaire to parents.
~Investigation of early, clinical and paraclinical prognostic factors of good or bad neurodevelopmental outcome.
~Evaluation of the height-weight growth and the cranial perimeter"
15887827|NCT03744468|Drug|BGB-A425|Humanized IgG1-variant monoclonal antibody against TIM-3
15887828|NCT03744468|Drug|tislelizumab|Humanized, IgG4-variant monoclonal antibody against PD-1
15887829|NCT03744455|Biological|Axillary Plexus|Axillary plexus anesthesia technique for hand surgery
15887830|NCT03744442|Procedure|Dignity Therapy (DT) module|psychotherapeutic intervention asking patients about their most important achievements, roles and other important aspects of life; two structured sessions of 60 minutes conducted by a trained therapist
15887831|NCT03744442|Procedure|CALM Therapy module|supportive-expressive psychotherapy aiming to help (1) manage the disease, symptom and treatment, and communicate with healthcare providers, to (2) adjust to changes in self-concept, personal relationships, and support needs, to (3) find a sense of meaning and purpose in life, and to (4) prepare for the future, sustain hope, and face the end of life; two structured sessions of 60 minutes conducted by a trained therapist
15887832|NCT03744442|Procedure|Mindfulness-based interventions module|Mind-body techniques reducing existential and spiritual distress and dealing with common experiences related to life-limiting diseases, including loss of control, uncertainty about the future; two structured sessions of 60 minutes conducted by a trained therapist
15887833|NCT03744429|Other|Mediterranean Diet|Participants will be provided with meals that follow a Mediterranean meal plan.
15887834|NCT03744416|Other|Counseling based on Epstein's active decision making|"Birth information leaflet. Based on the best evidence practice. Midwives' training on share decision making based on Epstein model. Pregnant intervention. The pregnant women will receive from the midwives the birth plan (BP) in the prenatal check at the health center, between the 24-28 weeks, to be completed at home. Later, on the visit between 29-33 weeks, the midwives will provide the birth information leaflet and carry out the counseling intervention based on shared decision making to the pregnant women. As well, midwives will deliver a second BP that pregnant woman will fill at home. On the prenatal check between 34 to 40 weeks, the midwife will save a copy of the latest BP. The midwife will instruct the woman to deliver the BP when she arrives to the hospital for birth."
15887835|NCT03744403|Drug|CS1001|In the dose-escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme. In the dose-expansion part, both dose levels will be expanded.
15887836|NCT03744390|Drug|AG-221|Subjects enrolled will receive continuous 28-day cycles of AG-221 -100 mg.
15887837|NCT03744377|Other|The Endometriosis Health Profile EPH-30|Self-reported questionnaires
15887838|NCT03744364|Drug|Misoprostol 25 mcg|To determine efficacy and safety of vaginal 'Misoprostol 25 mcg' every 4 hours with a maximum of 6 doses for induction of labor.
15887839|NCT03744364|Drug|Dinoprostone 10mg|To determine efficacy and safety of 'Dinoprostone 10mg' vaginal insert for induction of labor.
15898512|NCT03661320|Drug|Cisplatin|Specified dose on specified day
15887840|NCT03744351|Other|Biological Samples|Venous sampling that is performed solely for the purpose of research. The total blood volume taken is 80 ml maximum (8 tubes of 10 ml).
15887841|NCT03744351|Other|Biological Samples|"Eight additional 10 ml tubes of blood and an additional 5 ml CSF tube will be taken from the patient during a sample taken for the patient's usual check-up /follow-up.
~Inpatients will also be offered stool removal."
15887842|NCT03744351|Other|Biological Samples|The patient will be taken 8 additional tubes of 10 ml of blood (during a blood test performed for the usual assessment of the patient) and an additional 5 ml of CSF in a sample taken for the assessment of the patient.
15887843|NCT03744351|Other|Biological Samples|"Eight additional 10 ml tubes of blood will be taken from the patient during a sample taken for the patient's usual check-up / follow-up.
~Inpatients will also be offered stool removal"
15887844|NCT03744338|Other|questionnaire|"The questionnaire is composed of two parts:
~The first part let know the characteristics of the patients as age, the BMI, the socio-professional category, the current treatments, the medical-surgical antecedents of interest."
15887845|NCT03744325|Dietary Supplement|Hen's egg OIT|Increasing doses of egg white protein administered orally
15887846|NCT03744312|Drug|11C-ER176|11C-ER176 sticks to parts of the brain where there is inflammation. Past studies have shown that inflammation is present in the brains of patients with Alzheimer's disease. The purpose of this study is to determine if 11C-ER176 is able to accurately measure inflammation in patients with Alzheimer's disease.
15887847|NCT03744312|Drug|Florbetaben|Florbetaben sticks to amyloid plaques, which are in the brain in Alzheimer's disease.
15887848|NCT03744299|Other|Questionnaire|Patients and caregivers are asked to complete a questionnaire
15887849|NCT03744286|Device|Slip Training|-On a separate day (visit 2), using the identified optimal distance, a training session that involves 24 passes on the device where 1-2 planks move will be performed.
15887850|NCT03744273|Procedure|breast capsule biopsy|
15887851|NCT03744260|Diagnostic Test|Patients undergo ultrasound and lumbar MRI|Patients undergo ultrasound, physical therapy exam and MRI before and after the radiofrequency ablation procedure that they are getting as part of their regular care.
15887852|NCT03744247|Drug|Lenvatinib|12 mg (or 8 mg) once daily (QD) oral dosing.
15887853|NCT03744247|Drug|PD-1 antibody|3mg/kg intravenously every 2 weeks
15887854|NCT03744247|Drug|Placebo|Intravenously every 2 weeks
15887855|NCT03744234|Procedure|PRP|Autologous platelet-rich plasma
15887856|NCT03744234|Procedure|Steroid Injection|Steroid injection
15887857|NCT03744221|Dietary Supplement|Corn protein powder|40g/d ( 2 times 20 grams per day for a period of 1 week)
15887858|NCT03744221|Dietary Supplement|Bovine plasma protein powder|40g/d ( 2 times 20 grams per day for a period of 1 week)
15887859|NCT03744221|Dietary Supplement|Whey protein powder|40g/d ( 2 times 20 grams per day for a period of 1 week)
15887860|NCT03744208|Drug|Anti-EGFR monoclonal antibody|DDP(75mg/m2),d1; 5-FU(750mg/m2),d1-5, every 21d; PF chemothrapy up to 6 cycles. 6.0mg/kg of SCT200 will be administered once a week for a maximum of 6 cycles. After 6 cycles, 8.0mg/kg of SCT200 will be administered every two weeks until disease progression
15887861|NCT03744195|Other|Group I Experimental Kinesotaping|"For application of kinesotaping following procedure will be adopted:
~The skin will be cleaned properly with alcohol
~The first strip will be applied in Y-shape (15-20% stretch) surrounding the deltoid muscle to provide inhibition and muscle relaxation
~A second strip (I-shape) will be applied for functional correction (50-75% stretch), passing over the supraspinatus, trapezius, glenohumeral joint and middle deltoid Daily Strengthening Exercises (3 sets / 10~30 reps) Joint mobilization (3 sets / 60 seconds hold / 30 seconds interval) Stretching Exercises (3 sets / 30 seconds hold / 30 seconds interval"
15887862|NCT03744195|Other|Group II conventional training group|Joint mobilization (3 sets / 60 seconds hold / 30 seconds interval) Stretching Exercises (3 sets / 30 seconds hold / 30 seconds interval) Strengthening Exercises (3 sets / 10~30 reps)
15887863|NCT03744182|Drug|HM15211|A sterile solution of HM15211 contained in pre-filled syringes
15887864|NCT03744182|Drug|Placebo of HM15211|A sterile, matching solution in pre-filled syringes
15887865|NCT03744169|Diagnostic Test|Lung ultrasound|A point-of-care lung ultrasound exam will be performed on admission (no later than 14 hours following admission, allowing for participant stabilization and care) to the PICU and within 6 hours of any escalation in mechanical ventilatory support without interrupting clinical care, by study investigators blinded to participant history, physical examination, and diagnostic testing/imaging and who are not involved in the clinical management of the participant. Investigators will use a six-zone standardized scanning protocol with pattern analysis to form a diagnosis for the cause of the participant's respiratory failure. Images will be acquired by pediatric critical care trainees and saved online; accuracy of diagnoses based on the ultrasound exam will be evaluated by a expert sonographer offline.
15887866|NCT03744169|Diagnostic Test|Clinical exam|Following morning ICU rounds, the PICU fellow or attending physician caring for the participant will be asked for his/her interpretation of the most recent chest radiograph and his/her diagnosis concerning the etiology of the participant's acute respiratory failure. This clinical diagnosis will be compared to ultrasound findings.
15887867|NCT03744169|Diagnostic Test|Chest x-ray|Results of chest x-ray will be collected for comparison with ultrasound findings.
15887868|NCT03744156|Behavioral|Cognitive Behavioral Treatment-Insomnia|8 session Cognitive Behavioral Therapy for Insomnia. Individualized sessions with a therapist.
15887869|NCT03744156|Behavioral|Sleep Hygiene Education|8 Session Sleep Hygiene Education. Individualized sessions with a therapist.
15887870|NCT03744143|Procedure|longitudinal suture|Surgical eradication of deep infiltrating endometriosis of the vagina using laparoscopic technique, performing 4 transperitoneal abdominal accesses and trocars from 5 to 12 mm, and closure of the vagina with a longitudinal suture
15887871|NCT03744143|Procedure|transverse suture|Surgical eradication of deep infiltrating endometriosis of the vagina using laparoscopic technique, performing 4 transperitoneal abdominal accesses and trocars from 5 to 12 mm, and closure of the vagina with a transverse suture
15887872|NCT03744143|Procedure|Removal of vaginal endometriotic nodule|Surgical eradication of deep infiltrating endometriosis of the vagina using laparoscopic technique, performing 4 transperitoneal abdominal accesses and trocars from 5 to 12 mm, or vaginal technique, isolating the nodule through the vagina.
15887910|NCT03743805|Drug|Flumazenil|0.2 mg IV push, which may be repeated every 20 minutes for up to a total of 1 mg
15887873|NCT03744130|Diagnostic Test|Contrast-enhanced Ultrasound|"administration of drotaverine hydrochloride (No-Spa ®) to reduse excessive peristaltic movement
~visualization of the previously chosen affected bowel segment with the use of DCE-US (Dynamic Contrast-Enhanced Ultrasound) technology
~administration of 2.4 ml SonoVue® intravenously with a bolus injection through a peripheric venous line (left antecubital vein), followed by a 10ml 0.9% Natrium Chloride bolus
~the video-loop is acquired during contrast agent administration and wash-out (preferable loop duration - 3 min)
~the original DICOM loop is sent to a work station"
15887874|NCT03744117|Other|Palliative care consultation|A palliative care consultation will occur via telemedicine with patients receiving maintenance dialysis.
15887875|NCT03744104|Biological|Quadrivalent influenza vaccine|0.5 mL, intramuscular, one dose
15887876|NCT03744104|Biological|Trivalent influenza vaccine A|0.5 mL, intramuscular, one dose
15887877|NCT03744104|Biological|Trivalent influenza vaccine B|0.5 mL, intramuscular, one dose
15887878|NCT03744091|Drug|P1|10 mg or 20 mg of THC:THCa
15887879|NCT03744078|Device|Foley balloon catheter|18-F Foley catheter which filling with 60 mL of saline solution will be placed into the cervix
15887880|NCT03744065|Procedure|lumbar plexus block|Injection with ultrasound guidance of 40 mL of levobupivacaine 0.25% with 5 micrograms of epinephrine per mL and dexamethasone 4 milligrams, in the posteromedial quadrant of psoas muscle
15887881|NCT03744065|Procedure|suprainguinal fascia iliaca block|Injection with ultrasound guidance of 40 mL of levobupivacaine 0.25% with 5 micrograms of epinephrine per mL and dexamethasone 4 milligrams, underneath the fascia iliaca at the suprainguinal level
15887882|NCT03744052|Other|Motivational Messages|Messages regarding physical activity will be texted to participants.
15887883|NCT03744026|Device|SonoCloud-9|Escalating numbers of ultrasound beams at constant acoustic pressure
15887884|NCT03744026|Drug|Carboplatin|Dose of carboplatin infusion is AUC4-6
15887885|NCT03744013|Device|Fortiva® 1mm|Post mastectomy immediate reconstruction
15887886|NCT03744000|Procedure|Immediate stenting|Abciximab (0.25㎎/㎏) intracoronary injection will be performed to all possible patients after guidewire has passed culprit lesion. Additional manual thrombus aspiration or balloon angioplasty can be performed by operator to achieve TIMI Ⅲ flow. When TIMI Ⅲ flow is achieved after these procedures, patient will be randomized to immediate stenting or deferred stenting group. In immediate stenting group, stenting will be done immediate after achieving TIMI III flow during initial procedure.
15887887|NCT03744000|Procedure|Deferred stenting|Abciximab (0.25㎎/㎏) intracoronary injection will be performed to all possible patients after guidewire has passed culprit lesion. Additional manual thrombus aspiration or balloon angioplasty can be performed by operator to achieve TIMI Ⅲ flow. When TIMI Ⅲ flow is achieved after these procedures, patient will be randomized to immediate stenting or deferred stenting group. In deferred stenting group, second stage procedure (stent implantation) will be done at 3 to 7 days after TIMI Ⅲ flow has achieved.
15887888|NCT03743987|Procedure|control group|a procedure used to prevent or resolves apical periodontitis.
15887889|NCT03743987|Procedure|MTA group|a procedure used to prevent or resolves apical periodontitis.
15887890|NCT03743987|Procedure|PRF group|a procedure that is used for wound healing
15887891|NCT03743987|Procedure|MTA + PRF group|a procedure used to prevent or resolves apical periodontitis in combination with a procedure that is used for wound healing.
15887892|NCT03743974|Procedure|arthroscopic shoulder surgery of rotary cuff (ISB)|ISB were performed in the same manner by one of the two anesthesiologists in our team: (i) patients were monitored, after sedation with sublingual midazolam (0.1 mg/kg) + a single bolus of intravenous (IV) ketamine (0.2 mg/kg); (ii) ultrasound-guidance was carried out using a Kontron® or General Electric® ultrasound machine; (iii) neurostimulation was performed with a Stimuplex HNS® 12 set at 0.1 ms, 1 Hz and 1 mA stimulation, in sentinel mode, with the aim of securing the approach of the needle; (iv) a single perineural injection was performed with a 50 mm Vygon® needle containing a mixture of 100 mg levobupivacaine (20 mL, 0.5%) and clonidine (1 µg/kg patient) as is the local common protocol and in the absence of contraindications.
15887893|NCT03743974|Procedure|arthroscopic shoulder surgery of rotary cuff (CSB)|SCB were performed in the same manner by one of the two anesthesiologists in our team: (i) patients were monitored, after sedation with sublingual midazolam (0.1 mg/kg) + a single bolus of intravenous (IV) ketamine (0.2 mg/kg); (ii) ultrasound-guidance was carried out using a Kontron® or General Electric® ultrasound machine; (iii) neurostimulation was performed with a Stimuplex HNS® 12 set at 0.1 ms, 1 Hz and 1 mA stimulation, in sentinel mode, with the aim of securing the approach of the needle; (iv) a single perineural injection was performed with a 50 mm Vygon® needle containing a mixture of 100 mg levobupivacaine (20 mL, 0.5%) and clonidine (1 µg/kg patient) as is the local common protocol and in the absence of contraindications.
15887894|NCT03743961|Other|geriatric intervention|Geriatric intervention
15887895|NCT03743948|Genetic|Non invasive prenatal diagnosis|15 pregnant women and their spouses Search for the familial mutation on isolated circulating fetal trophoblastic cells from maternal blood
15887896|NCT03743935|Other|Gadolinium-enhanced cardiac MRI|Gadolinium-enhanced cardiac MRI during the 1st days post-STEMI with specific sequences including extra-cellular volume measurement
15887897|NCT03743922|Drug|Calciferol|calciferol capsule
15887898|NCT03743922|Drug|Placebo|placebo capsule
15887899|NCT03743896|Drug|Transdermal Glucosamine Cream|
15887900|NCT03743883|Drug|Acetylsalicylic Acid(BAYE4465, Aspirin )|Administration according to clinical practice
15887901|NCT03743870|Drug|Levobupivacaine|Levobupivacaine will be spinally administered, as required by normal clinical practice, at the dose of 12 mg 0,5% in combination with fentanyl 25γ.
15887902|NCT03743870|Drug|Bupivacaine|Bupivacaine has been spinally administered, as required by normal clinical practice, at the dose of 12 mg 0,5% in combination with fentanyl 25γ.
15887903|NCT03743857|Procedure|Manual Therapy|AP ankle mobilization
15887904|NCT03743844|Behavioral|Compassion-focused psychoeducation group|Attending six 2-hour weekly group-based psychoeducation sessions and participating in mindfulness, meditation, and acceptance-based experiential exercises
15887905|NCT03743831|Device|orotracheal intubation by direct laryngoscopy|Orotracheal intubation by direct laryngoscopy by metal blade type Macintosch
15887906|NCT03743831|Device|orotracheal intubation by indirect laryngoscopy|orotracheal intubation by indirect laryngoscopy by Airtraq
15887933|NCT03743649|Other|Placebo|Given IV
15887911|NCT03743805|Drug|Naloxone|0.4 mg IV push, which may be repeated every 2 minutes for up to a total of 2 mg
15887912|NCT03743792|Dietary Supplement|Active breakfast|freeze-dried red raspberry powder (12.5 g) in drink+ freeze-dried red raspberry powder (12.5 g) in buttermilk biscuit sandwich
15887913|NCT03743792|Dietary Supplement|Control breakfast|Control drink + buttermilk biscuit sandwich
15887914|NCT03743779|Behavioral|Mastering Diabetes|"The Mastering Diabetes provides a step-by-step program to transition to a low-fat, plant-based, whole-food lifestyle and reduce overwhelm. The program also provides direct access to expert coaches in the online community, which contains others living with all forms of diabetes. I includes access to live Q&A videoconferences twice per month to interact with coaches and personalize the experience.
~The program is designed with seven core modules. Many participants continue in the program after completion of the modules for ongoing support.
~The cost was $29/month or $249/year, but as of July 2018, only the $249/year option is offered."
15887915|NCT03743766|Drug|Relatlimab|Relatlimab (BMS-986016) - 10mg/mL formulation to be administered as an intravenous (IV) infusion at 160 mg IV.
15887916|NCT03743766|Drug|Nivolumab|Nivolumab (BMS-936558) - 10-mg/mL formulation to be administered as an IV infusion at 480 mg IV.
15887917|NCT03743766|Drug|Relatlimab + Nivolumab|Combination (Relatlimab + Nivolumab) therapy will be administered by sequential infusion. Nivolumab administered at 480 mg IV followed by infusion of relatlimab at 160 mg IV.
15887918|NCT03743753|Other|Experimental|The intervention is the educational session, which is a one-on-one session delivered by a research assistant using a visual aide on an iPad (power point presentation). The session is specifically tailored to the method of breast reconstruction (autologous or alloplastic) the patient will undergo and reviews the basics of their reconstruction, explains the normal in-hospital course and post-operative recovery, reviews potential complications and provides advice from previous breast reconstruction patients.
15887919|NCT03743740|Other|Spinal stabilization exercise|The effects of spinal stabilization exercise in patients with myasthenia gravis will be investigated.There is no study in the literature that previously applied spinal stabilization exercises in patients with myasthenia gravis. The benefits of spinal stabilization exercises in other diseases are shown.
15887920|NCT03743727|Drug|Combined therapy LDV and SOF|All patients will receive ledipasvir/sofosbuvir fixed dose combination for 12 weeks. Patients weighing 35 kg or more will receive the adult dose: ledipasvir (90 mg)/sofosbuvir (400 mg). Patients weighing below 35 kg will receive half the adult dose: ledipasvir (45 mg)/sofosbuvir (200 mg).
15887921|NCT03743714|Other|yoga treatment; flexibility, balance and strength exercises.|yoga treatment including flexibility exercises, balance exercises, and strength exercises.
15887922|NCT03743701|Diagnostic Test|The method of transrectal ultrasound in В-mode|A linear transrectal ultrasonic sensor with a frequency of 9 MHz is inserted into the rectum lumen to a depth of 10 cm from the edge of the anus. In real time, the rectal wall and anatomical structures of the anal canal are evaluated using linear sections. The localization of the internal fistula opening, the course of the fistula relative to the fibers of the external sphincter and the presence or absence of cellular and wall plug is determined.
15887923|NCT03743701|Diagnostic Test|The method of transrectal ultrasound examination using three-dimensional image reconstruction.|A mechanical circular transrectal ultrasonic sensor with a frequency of 13 MHz is inserted into the rectum lumen to a depth of 10 cm from the edge of the anus. Within 30 seconds with a scan interval of 2 mm with a length of 10 cm, a circular recording of the anatomical structures of the rectum, surrounding tissue and anal canal takes place, obtaining an array of images in the form of a cube. The study was completed. After, at a convenient time for the researcher is working with a three-dimensional array of images. The resulting cube can be rotated 360 degrees in a circle of its axis, work with the sagittal, frontal and axial plane. To obtain a more visual representation of the exact localization of the internal fistula orifice, the course of the fistula relative to the fibers of the outer sphincter and to design volumetric cellular and wall plug.
15887924|NCT03743688|Biological|Influenza Vaccine Recipients|0.5 mL intramuscular injection
15887925|NCT03743675|Behavioral|Diet-Induced Weight Loss|Diet-Induced Weight Loss: The goal of the diet intervention is to produce a weight loss of approximately 5-10% of body weight over the six-month period, which is consistent with the goals for obesity treatment outlined by the Academy of Nutrition and Dietetics (AND). According to the 2016 AND position paper for obesity-related interventions, this level of weight loss produces clinically significant reductions in biometrics (biochemical and anthropometrics measurements) and associated risk factors for chronic disease. Additionally, obese older adults who achieve weight loss intentionally through lifestyle changes experience improved physical function. This intervention will last for 6-months with bi-weekly face-to-face counseling sessions with a registered dietitian.
15887926|NCT03743675|Behavioral|Aerobic Exercise Training|"Exercise Intervention: Subjects will exercise on a cycle ergometer during the training sessions. Each session will consist of 1) a 5-10 minute warm up at light intensity; 2) a 20 to 30-minute training phase at moderate-to-vigorous intensity; and 3) a 5-minute cool down phase at light. The training will be conducted 3 days per week for 6 months."
15887927|NCT03743662|Radiation|Re-irradiation (RT)|Re-RT will start on day 28 +/- 5 days for 5 fractions of 600cGy every other day over a 2-week period.
15887928|NCT03743662|Drug|Bevacizumab|Bevacizumab if deemed beneficial by the investigator, will be started at the initiation of re-RT and continued for three doses in the medical arm. Patients in the surgical arm will omit the first bevacizumab dose to assure adequate wound healing after surgery and receive two doses. Bevacizumab will be dosed at 10mg/kg and given intravenously on day 28 (medical arm only), day 42 and day 56. Following day 56, further bevacizumab doses can be given every two weeks at the discretion of the treating physician.
15887929|NCT03743662|Drug|Nivolumab|"Nivolumab will be started at enrollment and each patient will receive two doses of nivolumab prior to radiation.
~Nivolumab will be dosed at 3mg/kg given intravenously before re-RT (day 1 +/- 5 and 14 +/- 5) and when given with bevacizumab if deemed beneficial by the investigator, (day 28 +/- 5 (medical arm only), day 42 +/- 5, and day 56 +/-5). Nivolumab will be dosed based on body weight while combined with re-radiation and bevacizumab for safety considerations to reduce adverse events. Single agent nivolumab will be given at 240mg flat dose every 2 weeks thereafter until disease progression, withdrawal, adverse event, or death."
15887930|NCT03743662|Procedure|Re-resection|Re-resection will be performed in the surgical arm at day 14 (+/- 5 days).
15887931|NCT03743649|Drug|Haloperidol|Given IV
15887932|NCT03743649|Drug|Lorazepam|Given IV
15887936|NCT03743636|Drug|Nicotinamide riboside|Participants randomized to the NR + resveratrol arm or the NR + placebo arm of the study will receive 1,000 mg of NR daily for six months.
15887937|NCT03743636|Drug|Resveratrol|Participants randomized to the NR + resveratrol arm of the study will receive 125 mg of resveratrol daily for six months.
15887938|NCT03743636|Other|Placebo|Participants randomized to the NR + placebo arm of the study will receiving placebo pills that are identical in appearance to resveratrol. Participants randomized to the placebo + placebo arm of the study will receive pills that are identical in appearance to NR and resveratrol. Participants will receive placebo pills daily for six months.
15887939|NCT03743623|Device|Neurocytotron|Neurocytotron utilizes a combination of instantaneous magnetic field and low-spectrum radiofrequency waves for therapeutic purpose. Its working principle is based on the theory of magnetic resonance.
15887940|NCT03743623|Device|Placebo|Same treatment procedures without being actually exposed to electromagnetic waves and magnetic field
15887941|NCT03743610|Other|Simulated altitude|Participants will exercise in simulated altitude will range between 2100 feet and 16400 feet and will increase according to arm guidelines
15887942|NCT03743610|Other|Placebo simulated altitude|Participants will exercise at sea level at similar percentage of intensities to the simulated altitude group.
15887943|NCT03743597|Device|SOCKNLEG|"Innovative multilayer leg compression stocking, compression strength CEN compression class II (European Compression Strength) with compression at the ankle of 23-32mmhg, product composition understocking (polyamide, cotton, spandex), overstocking (polyamide, spandex)
~In each participant all examinations will be performed with both study stockings, one after the other"
15887944|NCT03743597|Device|Sigvaris COTTON|"Standard single leg compression stocking, compression strength CEN compression class II (European Compression Strength) with compression at the ankle of 23-32mmhg, product composition one stocking (polyamide, spandex, cotton)
~In each participant all examinations will be performed with both study stockings, one after the other"
15887945|NCT03743584|Procedure|Targeted temperature management|Target temperature management at 33°C
15887946|NCT03743584|Procedure|Standard care, early treatment of fever|Standard of care with early treatment of fever
15887947|NCT03743571|Device|transcranial direct current stimulation|tDCS will be applied over EEG coordinate FpZ to target mPFC activation during exposure therapy
15887948|NCT03743571|Behavioral|exposure therapy|participants will complete one session of exposure therapy for fear of public speaking, which will involve providing speeches to audiences in virtual reality
15887949|NCT03743558|Behavioral|smartphone homemade video|value of a video recording of the child sleep on smartphone made by the parents
15887950|NCT03743545|Other|low speed drilling without irrigation|comparing between conventional implant placement drilling speed with irrigation and experimental arm (low speed without irrigation)
15887951|NCT03743532|Behavioral|JUUL/e-cigarette|Participants will receive a JUUL/e-cigarette device and JUUL pods. Each participant in this group will be yoked to a participant in the financial incentives group, thus receiving equal payments. Yoking will reduce or eliminate differential attendance rates between groups because participants have the opportunity to earn the same amount of money regardless of group assignment. Participants will be followed for the first 4 weeks following a scheduled quit attempt.
15887952|NCT03743532|Behavioral|Financial incentives + JUUL/e-cigarette|Participants will receive a JUUL/e-cigarette device and JUUL pods and the opportunity to earn financial incentives for biochemically-verified cigarette smoking abstinence, credited to a gift card with biochemical evidence of smoking abstinence during the first 4 weeks following a scheduled quit attempt.
15887953|NCT03743519|Dietary Supplement|Cherry juice|30 mL of tart cherry juice concentrate, which will be diluted with 200 mL of water.
15887954|NCT03743519|Dietary Supplement|Placebo|Identical in taste and colour to the Cherry juice, but with no anthocyanin content
15887955|NCT03743506|Diagnostic Test|With feedback|To evaluate the displacement of the center of pressure on the disc during the equilibration with feedback.
15887956|NCT03743506|Diagnostic Test|Without feedback|To evaluate the displacement of the center of pressure on the disc during the equilibration without feedback.
15887957|NCT03743480|Other|early palliative care|experimental arm. Patients in this arm will meet with the palliative care team soon after the decision on their last active treatment
15887958|NCT03743467|Diagnostic Test|Clinical evaluation of vision and eye tests|"VFQ-25 Questionnaire
~BCVA
~Contrast sensitivity
~Color sensitivity examination (Ishihara test 38 plates)
~Complete evaluation of orthoptic features, eye movements, eyelid function, pupil function
~Slit lamp examination
~Shirmer test, Break up time test
~Corneal pachymetry (optical pachymetry)
~IOP
~Quantitative and qualitative analysis of the macular area and of the optical disc by OCT: RPE, RNFL and Neuroretine Layer"
15887959|NCT03743454|Other|No intervention|No intervention will be applied.
15887960|NCT03743441|Other|Low-level Laser Therapy|LLLT, 904 nm wavelength, 3 Joules per treatment point in accordance with World Association for Laser Therapy (WALT) guidelines.
15887961|NCT03743441|Other|Sham Low-level Laser Therapy|Same procedure as in the LLLT group with the exception of laser irradiation (0 mW mean output power).
15887962|NCT03743441|Other|Exercise therapy|Concentric and eccentric exercises with a total duration of approximately 20 minutes.
15887963|NCT03743441|Other|Cryotherapy|Twenty minutes of cryotherapy applied to the Achilles tendon.
15887964|NCT03743428|Drug|Apatinib Mesylate Tablets|Apatinib combinated with FOLFIRI regimen as the second-line chemotherapy for mCRC
15887965|NCT03743428|Drug|Bevacizumab Injection|Bevacizumab combinated with FOLFIRI regimen as the second-line chemotherapy for mCRC
15887966|NCT03743415|Behavioral|Handbook|see arm/group descriptions
15887967|NCT03743415|Behavioral|TIP-C plus Handbook|see arm/group descriptions
15887968|NCT03743402|Behavioral|Pain self-management training|"This intervention will have 4 components:
~telephone-delivered evidence-based pain self-management training,
~web-based video of successfully tapered patients with motivational interviewing debriefing,
~a voluntary, self-paced opioid taper
~opioid and non-opioid prescribing guidance for the patient's primary care provider."
15887969|NCT03743402|Behavioral|video education, motivational interviewing|web-based video of successfully tapered patients with motivational interviewing debriefing
15888031|NCT03742986|Drug|Trastuzumab 8mg/kg and 6 mg/kg|Trastuzumab 8mg/kg IV on Day 1 of Cycle 1 and then 6mg/kg IV on Day 1 of Cycle 2-4
15887970|NCT03743402|Drug|voluntary self-paced opioid taper|Voluntary self-paced opioid taper where patient chooses whether, when and how much to taper opioids. Taper schedule and strategy will be proposed to patients, but they may modify it as wished.
15887971|NCT03743402|Drug|prescribing guidance for primary care provider|Based upon review of medications and diagnoses in the electronic medical record, the principal investigator will offer guidance on opioid taper rate and strategy. He will also offer suggestions to adjust or initiate other psychotropic medications to treat pain or psychiatric comorbid illness that may be unmasked through opioid taper
15887972|NCT03743402|Other|usual care|Usual care will consist of any and all regular care that may be offered by primary care for chronic pain and related illnesses
15887973|NCT03743389|Device|12G pigtail catheter|12G pigtail catheter would be used for post-operative chest drainage after uniportal-VATS for mediastinal nodes resection when comparing with the traditional 16F chest tube.
15887974|NCT03743389|Device|16F chest tube|16F chest tube would be used for post-operative chest drainage after uniportal-VATS for mediastinal nodes resection when comparing with 12G pigtail catheter.
15887975|NCT03743376|Biological|UB-421(25 mg/kg) Q2W|Monoclonal antibody by IV infusion plus standard ART
15887976|NCT03743376|Biological|UB-421(25 mg/kg) Q4W|Monoclonal antibody by IV infusion plus standard ART
15887977|NCT03743363|Other|Exergame 2/week|virtual training 2 times a week(8 week-long)
15887978|NCT03743363|Other|Exergaming 3/week|virtual training 3 times a week(8 week-long)
15887979|NCT03743363|Other|Healthy control / Exergaming 1/week|In the first 8 week-long only control group. For the next 8 weeks, the control group will do 1 workout per week.
15887980|NCT03743324|Procedure|Immediate Breast reconstruction|Immediate Autologous/prosthetic-based breast reconstruction is performed after mastectomy on the breast that is diagnosed with breast cancer
15887981|NCT03743324|Procedure|Delayed Breast Reconstruction|Delayed Autologous/prosthetic-based breast reconstruction is performed after mastectomy on the breast that is diagnosed with breast cancer
15887982|NCT03743324|Radiation|Radiation|Radiation is performed to the surgical site and complies with the ASCO guidelines on post-mastectomy radiotherapy
15887983|NCT03743311|Procedure|Hemorrhoidectomy, Thrombectomy , Operation on Longo method|Surgical procedures for treatment of Hemorhoid
15887984|NCT03743311|Drug|Detralex|Conservative treatment of Hemorhoid
15887985|NCT03743311|Other|Combined therapy|Surgical + conservative treatment of Hemorhoid
15887986|NCT03743298|Drug|AV-MEL-1|AV-MEL-1: Autologous dendritic cells loaded with autologous tumor antigens (ATA) from a short-term cell culture of autologous tumor cells. AV-MEL-1 is admixed with granulocyte-macrophage colony stimulating factor (GM-CSF) as an adjuvant, prior to injection.
15887987|NCT03743285|Device|AID System|AID system
15887988|NCT03743285|Drug|Insulin Lispro|Individualized doses of insulin lispro administered via the AID system to maintain glycemic control, except during procedures designed to induce hyperglycemia and hypoglycemia.
15887989|NCT03743272|Device|LiverMultiScan|Up to 6 separate 5-10 minute abdominal MRI scans. Each scan requires a short breath hold.
15887990|NCT03743259|Drug|LuminoMark inj. 0.1mL|Injection LuminoMark inj. (Conc. for fluorescence) 0.1mL once in this study.
15887991|NCT03743259|Drug|LuminoMark inj. 0.2mL|Injection LuminoMark inj. (Conc. for fluorescence) 0.2mL once in this study.
15887992|NCT03743259|Drug|Charcotrace Inj.|Injection Charcotrace Inj. about 0.3~1mL once in this study.
15887993|NCT03743246|Drug|JCAR017|JCAR017
15887994|NCT03743246|Drug|Lymphodepleting|Lymphodepleting
15887995|NCT03743246|Drug|Fludarabine|Fludarabine
15887996|NCT03743246|Drug|Cyclophosphamide|Cyclophosphamide
15887997|NCT03743233|Device|Hand file|A crown-down technique will be performed until reaching the provisory WL. The root canals will be initially deobstructed with size #3 and #2 Gates-Glidden burs (Dentsply-Maillefer) at the coronal and middle root thirds. Then, hand stainless steel K-files (Dentsply-Maillefer) with decreasing sizes will be used (#40, #35, #30, #25). The WL will be determined by an electronic apex locator (Novapex; Forum Technologies, Rishon Le-Zion, Israel). A radiograph will be taken to confirm the WL, which should be 1 mm short of the root apex. Apical patency will be reached and maintained with a size #15 K-file (Dentsply-Maillefer). The root canals will be reinstrumented and a size #50 K-file will be standardized as the master apical instrument. A step-back procedure in 1-mm increments followed until merging with the crown-down rotary enlargement (size #70) will be achieved.
15887998|NCT03743233|Device|Reciprocating|Reciproc R25 file will be used for gutta-percha removal, until reaching the WL. The instrument will be introduced into the canal applying slight movements of 3-mm amplitude. Apical patency will be maintained with a size #15 K-file. The root canals will be reinstrumented using the Reciproc R50 file. For both groups, after the root canal filling removal and reinstrumentation protocol, a new radiograph will be taken, without any intracanal instrument, for posterior analysis of the percentage of remaining filling material in the root canal. If the radiograph demonstrates the persistence of filling material, the technique will be repeated with the last instrument used in the chemomechanical preparation (hand or reciprocating file), also using H-files with circumferential movements against the dentinal walls in order to remove these residual material, followed by abundant irrigation with NaOCl.
15887999|NCT03743207|Other|Room temperature|These infants were fed with room temperature (22-24 °C) so that hypothesizing that they will have more feeding tolerance and therefore more co-existing morbidities.
15888000|NCT03743207|Other|Warmer temperature|Fifteen NICU mothers volunteered and expressed their milk for rapid measurement of freshly expressed breast milk. The mean (± SD) temperature of freshly expressed breast milk was found to be 33±1.5 °C in these preliminary measurements. Confirming this finding, the investigators decided to feed these infants with milk at 32 - 34 °C to examine the effects of feeding temperature and the possible comorbidities with a hypothesis that warmer feeding at the temperature of freshly expressed breast milk may be better physiologically.
15888032|NCT03742986|Drug|Pertuzumab 840mg and 420mg|Pertuzumab 840mg on Day 1 of Cycle 1 and then 420mg IV on Day 1 of Cycle 2-4
15888033|NCT03742973|Drug|Baricitinib|Administered orally.
15888034|NCT03742973|Drug|Placebo|Administered orally.
15888035|NCT03742960|Behavioral|Behavioral Sleep Restriction|Participants will be instructed to go to bed 30 minutes later than their usual bedtime. On the other hand, wake up time will be unchanged resulting a nightly sleep restriction of 30 minutes. This protocol will be followed for two weeks.
15888001|NCT03743194|Drug|Exparel 266 MG Per 20 ML Injection|The local anesthetic (LA) used for the PECS II or serratus plane blocks will be a 0.5% bupivacaine HCL, not to exceed 2.5mg/kg or up to 150mg. The LA solution can be diluted with preservative free normal saline for smaller patients to allow for appropriate volume of injection. Treatment patients will also be given liposomal bupivacaine (EXPAREL, Pacira Pharmaceuticals, Inc. San Diego, CA) in a dose of 266 mg in 20 ml can be safely combined with bupivacaine HCL at a ratio not exceeding 2:1, but cannot be combined with other local anesthetics due to the concern of rapid release of encapsulated bupivacaine and subsequent local anesthetic toxicity.
15888002|NCT03743194|Drug|Placebo|Patients randomized to standard analgesia technique will be given pain medications.
15888003|NCT03743181|Other|pharmaceutical care services|detection of drug therapy problems and investigation of the impact of clinical pharmacist interventions on the patient clinical outcome and quality of life
15888004|NCT03743168|Other|Intermittent stretching protocol|Intermittent stretching protocol of five sets of 1 minute and15 second rest
15888005|NCT03743168|Other|Continuous stretch|2 minutes continuous stretch
15888006|NCT03743155|Biological|mesenchymal cells|Autologous bone marrow aspiration is used as a cellular source to obtain MSVs and is subjected to the protocolized anticoagulant procedure. After checking the perfect condition of the shipment and the correct completion of the documentation that accompanies it, the processing of the bone marrow will be carried out. The processing of the bone marrow will be done in the Cell Therapy Unit of the IBGM under NCF, within 24 hours of the completion of the aspiration
15888007|NCT03743142|Procedure|endovascular repair of the AAA|The Investigator will ensure that investigational devices are used only in subjects properly enrolled in the clinical study in accordance with the protocol. Subjects will undergo endovascular repair of their AAA. Procedural details may vary between sites, but will follow standard hospital protocol for EVAR and patient care management.
15888008|NCT03743129|Drug|Anlotinib|Anlotinib 12mg p.o, qd
15888009|NCT03743103|Drug|Brevibloc, 10 Mg/mL Intravenous Solution|10 mL/h every 5 minutes until reaching the pressure target
15888010|NCT03743103|Drug|Nitroprusside, Sodium|0.5 ug/kg/min every 3 minutes until reaching the pressure target
15888011|NCT03743090|Diagnostic Test|Polysomnography.|A polysomnography will be performed for all of the patients the day before surgery (value of reference), and on the second postoperative day (in order to examine the influence of ECC on the development of OSA).
15888012|NCT03743077|Behavioral|Exercise training including inspiratory muscle training|Volunteers will participate in the the spinal mobility fitness training program for a frequency of one to 3 times a week with pre and post tests including four objective measures of function (timed t-shirt test, timed transfer test, four direction reach test and trunk test of strength) and a pre and post subjective interview. In addition to the program consenting volunteers will perform inspiratory muscle training as a home program and submit weekly diaries tracking their training. The inspiratory muscle trainer by Respironics provides specific pressure for inspiratory muscle strength and endurance, regardless of how quickly or slowly patients breathe. It exercises respiratory muscles and improves breathing. It Improves muscle strength and is easy to use.
15888013|NCT03743064|Drug|anamorelin HCl|100 mg anamorelin HCl (administered as 100 mg tablets in the fasted condition)
15888014|NCT03743064|Drug|Placebo Oral Tablet|Placebo (administered as matching placebo tablets in the fasted condition)
15888015|NCT03743051|Drug|Anamorelin Hydrochloride|100 mg anamorelin HCl (administered as 100 mg tablets in the fasted condition)
15888016|NCT03743051|Drug|Placebo Oral Tablet|Placebo (administered as matching placebo tablets in the fasted condition)
15888017|NCT03743038|Drug|FMX101 vehicle|FMX101 vehicle - hydrophobic oil based vehicle (Test Article A)
15888018|NCT03743038|Other|Hydro-alcohol solution|Hydro-alcohol solution based vehicle (Test Article B)
15888019|NCT03743025|Drug|Dulaglutide Injection|Participants randomized at pre-surgery/anesthesia visit and without a history of DM will receive a single injection of Dulaglutide injection: 0.75 mg/0.5 mL solution in a single-dose pen 1 to 3 days prior to surgery
15888020|NCT03743025|Other|Saline Injection|Participants randomized at pre-surgery/anesthesia visit and without a history of DM will receive a single injection of Saline injection/0.5 mL pre-drawn solution 1 to 3 days prior to surgery
15888021|NCT03743012|Other|Integrated cardiac rehabilitation|Participants enrolled to the integrated cardiac rehabilitation arm will participate in individually tailored rehabilitation sessions that will involve aerobic activity focused on exertion at the participant's aerobic threshold (AT) over a duration of three months.
15888022|NCT03743012|Other|Usual Care|Participants randomized to the usual care arm will be instructed on the benefits of exercise and continue with usual care. Participant activity will be tracked monthly using pedometers for three months of follow up.
15888023|NCT03742999|Procedure|physical therapy program|this group received specially designed physical therapy program to facilitate eye-hand coordination and fine motor to improve VMI, VP and MC, which included: unbutton buttons, and button in all again; put the pellets in the bottle as fast as he/she can; place the shapes on its form board; build steps, wall, pyramid and a tower from cubes; cut out a line, square, triangle, and rectangular shapes on a paper by scissor; string squared cubes and lace the holes of strip. Children were trained for 60 minutes per session, three times a week for three consecutive months.
15888024|NCT03742999|Device|E-Link Upper Limb Exerciser|The exercises in the E-Link Upper Limb Exerciser System are in the form of simple and exciting games such as soccer, hitting walls, space shooting, driving, arnd throwing balls into a bucket.Children were trained for 60 minutes per session, three times a week for three consecutive months
15888025|NCT03742999|Combination Product|physical therapy program and ELink Upper Limb Exerciser|physical therapy program and E-Link Upper Limb Exerciser. Children were trained for 60 minutes per session, three times a week for three months
15888026|NCT03742986|Drug|Nivolumab 360mg|Nivolumab 360 mg IV on Day 1 of every 21 day cycle (Cycle 1-4)
15888027|NCT03742986|Drug|Paclitaxel 80mg/m^2|Paclitaxel 80mg/m^2 IV on Day of 1, 8, 15 of every 21 day cycle (Cycle 1-4)
15888028|NCT03742986|Drug|Doxorubicin 60mg/m^2|Doxorubicin 60 mg/m^2 IV on Day 1 of every 14 day cycle (Cycle 5-8)
15888029|NCT03742986|Drug|Cyclophosphamide 600mg/m^2|Cyclophosphamide 600mg/m^2 on Day 1 of every 14 day cycle (Cycle 5-8)
15888030|NCT03742986|Drug|Paclitaxel 80mg/m^2 or Docetaxel 75mg/m^2|Paclitaxel 80mg/m^2 on Day 1, 8, 15 of every 21 day cycle (Cycle 1-4) OR Docetaxel 75mg/m^2 on Day 1 of every 21 day cycle (Cycle 1-4)
15888036|NCT03742947|Diagnostic Test|peripartum haemostasis|Three blood samples of 20 ml each at T0 after the anaesthesia for the caesarean section and before the administration of the product (TXA or placebo), T15 fifteen minutes after the administration of the product and T120, 2 hours after the administration of the product.
15888037|NCT03742934|Other|Short peptide|Short peptide formula during bowel preparation
15888038|NCT03742934|Other|Liquid diet|Liquid diet during bowel preparation
15888039|NCT03742921|Drug|Istodax|Istodax
15888040|NCT03742908|Drug|Cefazolin/clindamycin|Local implant immersion and/or breast pocket irrigation
15888042|NCT03742882|Drug|CC-90001|CC-90001
15888043|NCT03742869|Combination Product|A multi-omics analysis|A multi-omics analysis including genome-wide association study, whole exome sequencing, transcriptomics and metabolomics.
15888044|NCT03742856|Combination Product|A multi-omics analysis|A multi-omics analysis including whole exome sequencing, transcriptomics and metabolomics.
15888045|NCT03742843|Combination Product|A multi-omics analysis|A multi-omics analysis including whole exome sequencing, transcriptomics and metabolomics for eutopic and ectopic endometrium
15888046|NCT03742830|Device|C-MAC VS|C-MAC VS, Karl Storz AG, 78532 Tuttlingen, Germany It has a flexible tip and a distal angular offset, in which the camera and light sources are integrated. It can be aligned (up to 60°) to the patient's anatomical structures to facilitate intubation.
15888047|NCT03742817|Other|e-Cigarette|Participants will self-administer an experimenter-provided e-cigarette.
15888048|NCT03742804|Biological|Intratumoral G100|G100 agent is a potent Toll-like receptor (TLR)4 agonist. G100 is composed of glucopyranosyl lipid A (GLA) formulated in a stable emulsion (SE). GLA is a fully synthetic TLR4 agonist that is a potent stimulator of innate immune responses.
15888049|NCT03742791|Drug|TS-134|5 mg to 80 mg oral solution
15888050|NCT03742791|Drug|Placebo|Matched Placebo oral solution
15888051|NCT03742778|Behavioral|Incentivizing reflection|Participants receive bonus incentives for reflecting on their workouts
15888052|NCT03742778|Behavioral|Incentivizing exercise|Participants receive bonus incentives for exercising
15888053|NCT03742765|Behavioral|Incentivizing planning|Participants receive bonus incentives for planning their workouts
15888054|NCT03742765|Behavioral|Incentivizing exercise|Participants receive bonus incentives for exercising
15888055|NCT03742752|Other|Enteral nutrition|administration of enteral nutrition
15888056|NCT03742752|Other|Parenteral nutrition|administration of parenteral nutrition
15888057|NCT03742726|Device|Smart Matrix scaffold|Smart Matrix dermal replacement scaffold
15888058|NCT03742713|Drug|CPC634 (CriPec® docetaxel)|Docetaxel containing CriPec® nanoparticles
15888059|NCT03742700|Behavioral|Cigarette smoking|T-smokers were asked to smoke a cigarette of one of the popular brands (0.6mg nicotine per one cigarette) according to their everyday habits.
15888060|NCT03742700|Behavioral|E-cigarette use|E-smokers and dual users were instructed to use e-cigarettes (12 mg/ml nicotine) in accordance with everyday habits for 5 minutes.
15888061|NCT03742700|Behavioral|Simulation of the use of e-cigarette|The control subjects were asked to simulate the use of e-cigarettes (a device without e-liquid where aerosol was not created or inhaled).
15888062|NCT03742687|Radiation|Heterogeneously Hypofractionated Radiotherapy|A heterogeneous hypofractionated schedule for the treatment of high-risk locally advanced NSCLC patients in which the central idea is to decrease dose to normal tissue by ascribing a heterogeneous dose to the PTV. The dose to the periphery of the PTV as well as to the majority of lymph node targets is decreased compared to a standard treatment. The gross volume of the primary tumour and bulky lymph nodes receive mean doses of up to 66 Gy in 24 fractions, and thus receive a hypofractionated higher biological effective dose than standard 66 Gy in 33 fractions.
15888063|NCT03742674|Other|Follow up|No intervention
15888064|NCT03742661|Device|SPEAC System|Surface Electromyography (sEMG) based seizure monitoring and alerting system
15888065|NCT03742648|Other|Physiotherapy|Chest physiotherapy in burn patients in order to treat and prevent post burn respiratory complications like pneumonia etc
15888066|NCT03742635|Other|General Movements Assessment|Prechtl's Assessment of General Movements (GMA) is a tool used in early infancy to identify infants at high risk of cerebral palsy and neurodevelopmental impairment. General movements are complex motor patterns that involve the entire body, moving fluidly in different directions through the arms, legs, and trunk with variable speed, amplitude, force and intensity. During fetal development, spontaneously generated motor patterns, including general movements, can already be observed. The GMA is a functional assessment of the maturing nervous system that takes advantage of the fact that typically developing infants will have a progression in their general movements. This pattern is characterized by a writhing pattern in the early weeks post-term, followed by the emergence of fidgety movements at 3-5 months of age.
15888067|NCT03742622|Behavioral|CON . control condition without exercise / rest condition|CON . Control condition without exercise / rest condition. The adolescents will be asked to remain quiet and at rest during the morning and will receive an ad libitum meal at lunch and dinner times. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.
15888068|NCT03742622|Behavioral|EX. Condition with an acute exercise set in the middle of the morning|EX. Condition with an acute exercise set in the middle of the morning The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling) in the morning and will receive an ad libitum meal at lunch and dinner times. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals
15888069|NCT03742622|Behavioral|EX+R. condition with an acute exercise set in the morning and followed by a energy replacement snack|EX+R. condition with an acute exercise set in the morning and followed by a energy replacement snack The adolescents will be asked to complete a 30 minutes exercise set at 65% of their capacities (cycling) in the morning followed by a snack that will cover the whole exercise-induced energy expenditure. They will then receive an ad libitum meal at lunch and dinner times. Their food reward will be assessed before and after lunch. Their appetite feelings will be assessed at regular intervals.
15888070|NCT03742609|Other|ii) the reminder|Participants assigned to the prompt group were received instruction to use their hearing aid box as a physical prompt to remind participants to use their hearing aid(s)
15888071|NCT03742609|Other|ii) written behavioural plan|Participants assigned to this group were received instruction to create at least one written plan for hearing aid use. Specifically, participants were asked to plan where and when to use their hearing aid(s).
15888072|NCT03742609|Other|iv) all materials|i) provision of written information regarding consequences of using a hearing aid and not using a hearing aid, ii) the provision of a physical prompt for the purpose of prompting or cueing the behavior (hearing aid use) development, and iii) creation of a written behavioural plan for hearing aid use.
15888073|NCT03742596|Dietary Supplement|Probiotic Formula Capsule|The Probiotic will be coded in a specific label by a researcher. The patient will receive 2 bottles of the drug every 2 weeks and will be followed weekly for 7 weeks.
15888074|NCT03742596|Drug|Control|The Placebos will be coded in a specific label by a researcher.
15888075|NCT03742583|Other|Square Knot|Standard square knot
15888076|NCT03742583|Other|RHAP Knot|Reversing half-hitch alternating post knot
15888077|NCT03742570|Behavioral|CBBDQ|a questionnaire for childood bladder and bowel dysfunctions
15888078|NCT03742557|Drug|Ketamine 50 MG/ML Injectable Solution, 0.5 mg/kg IV|Ketamine 0.5 mg/kg IV
15888079|NCT03742531|Drug|oxytocin|one group will be treated with low dose oxytocin and the other group will be treated with high dose oxytocin for augmentation of labor induction.
15888080|NCT03742518|Drug|Topical SM04554 solution|Study medication application will be performed by the individual subject at approximately the same time each day.
15888081|NCT03742518|Drug|Topical SM04554 solution|Study medication application will be performed by the individual subject at approximately the same time each day.
15888082|NCT03742518|Drug|Topical vehicle solution|Vehicle solution application will be performed by the individual subject at approximately the same time each day.
15888083|NCT03742505|Drug|Cholecalciferol|Single enteral cholecalciferol load at a dose of 10,000 IU/kg (maximum 400,000 IU)
15888084|NCT03742505|Other|Placebo|Single enteral placebo dose equivalent in volume to the appropriate weight-based dose of cholecalciferol
15888085|NCT03742492|Dietary Supplement|Meal containing canned tuna + fish oil (5 g EPA + DHA)|Meal containing canned tuna + fish oil (5 g EPA + DHA)
15888086|NCT03742492|Dietary Supplement|Meal containing canned tuna + soybean oil|Meal containing canned tuna + soybean oil
15888087|NCT03742479|Device|Restylane® Silk|Injectable Hyaluronic Acid (HA)
15888088|NCT03742466|Drug|Ozone|After prepping and draping the area, intracarpal injection of ozone/oxygen mixture (20 ml, 25μg/ml) will be performed under sonographic guidance
15888089|NCT03742466|Drug|methylprednisolone acetate|After prepping and draping the area, intracarpal injection of methylprednisolone acetate 40mg, and 40 mg lidocaine (20 ml, volume) will be performed under sonographic guidance
15888090|NCT03742453|Diagnostic Test|contrast-enhanced ultrasound|CEUS is performed using SonoVue (Bracco, Milan, Italy) intravenous administration in eligible participants within a month before/after EOB-MRI.
15888091|NCT03742453|Diagnostic Test|EOB-MRI|EOB-MRI is performed using standard dose of hepatocyte specific contrast media (primovist or eovist) according to standard protocol of our institution.
15888092|NCT03742440|Biological|GrafixPL PRIME|GrafixPL PRIME
15888093|NCT03742427|Diagnostic Test|ultrasonography|optic nerve sheath diameter measurement will be done by ultrasonography on both eyes
15888094|NCT03742414|Combination Product|Tri-lipid skin barrier cream (Epiceram)|The aim is to compare the effect of proactive sequential skin care, including the twice daily use of a tri-lipid skin barrier cream (Epiceram) and proactive use of fluticasone proprionate cream, against reactive AD therapy, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).
15888095|NCT03742414|Combination Product|Fluticasone propionate Cream 0.05%|Proactive use of fluticasone proprionate cream for inflammation of the skin, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).
15888096|NCT03742414|Combination Product|Moisturizer|The aim is to compare the effect of proactive sequential skin care, including the twice daily use of a moisturizer and proactive use of fluticasone proprionate cream, against reactive AD therapy, to reduce the occurrence and severity of AD in early infancy and thereby prevent food allergy (FA).
15888097|NCT03742414|Other|Standard of Care|Participants' eczema will be managed by their primary physician, i.e. standard of care with routine reactive topical products for atopic dermatitis flares.
15888098|NCT03742401|Procedure|Surgery|Traditional open excisional surgery
15888099|NCT03742401|Device|HIFU (Echopulse)|High intensity focused ultrasound (HIFU) non invasive intervention
15888100|NCT03742375|Diagnostic Test|HPV genotyping|Quantitative HPV genotyping on anal swab
15888101|NCT03742362|Device|MRI scans of distal radius|MRI scans to monitor the fat fraction in the bone marrow of the distal radius
15888102|NCT03742349|Biological|spartalizumab|LIVI (Liquid in vial) Concentrate for Solution for infusion
15888103|NCT03742349|Biological|LAG525|LAG525 LIVI (Liquid in vial) Concentrate for Solution for infusion
15888104|NCT03742349|Drug|NIR178|Capsule
15888105|NCT03742349|Drug|capmatinib|Tablet
15888106|NCT03742349|Biological|MCS110|LIVI (Liquid in vial) Concentrate for Solution for infusion
15888107|NCT03742349|Biological|canakinumab|LIVI (Liquid in vial) Solution for injection
15888108|NCT03742336|Drug|PF-04965842|Single oral 200 mg dose of PF-04965842
15888109|NCT03742336|Drug|Dabigatran|Single 75 mg dose of dabigatran
15888110|NCT03742323|Drug|Idelalisib|Idelalisib Dose: 100, 150, 200 or 300 mg (in four cohorts of six patients each).
15888111|NCT03742310|Drug|Vitamin D|Vitamin D is essential for healthy bones, and to control the amount of calcium in our blood.It is important at every stage of life, but especially for rapidly growing infants and teenagers and for pregnant and breastfeeding women.
15888112|NCT03742297|Drug|Lenalidomide.|Lenalidomide
15888113|NCT03742297|Drug|Carfilzomib|Carfilzomib
15888114|NCT03742297|Drug|Bortezomib|Bortezomib
15888115|NCT03742297|Drug|Daratumumab|Daratumumab
15888116|NCT03742297|Drug|Dexamethasone|Dexamethasone
15888117|NCT03742297|Drug|Prednisone|Prednisone
15888118|NCT03742297|Drug|Melphalan|Melphalan
15888159|NCT03742037|Drug|Cenerimod 1 mg|Cenerimod will be supplied as a film-coated tablets at the dose of 1 mg
15888160|NCT03742037|Drug|Cenerimod 2 mg|Cenerimod will be supplied as a film-coated tablets at the dose of 2 mg
15888119|NCT03742284|Device|SoftOx Wound Irrigation Solution|"The SoftOx Wound Irrigation Solution is a Medical device that contains a combination of hypochlorous acid and acetic acid in purified water. SWIS is primary intended for mechanical irrigation of acute wounds whereas hypochlorous acid acts as a ancillary medicinal (drug) substance with potential antimicrobial effects.
~Acute wounds will be rinsed according to protocol and safety (AEs/ADEs/SAEs/SADEs) is the primary objective."
15888120|NCT03742271|Device|senofilcon A|TEST Lens
15888121|NCT03742258|Drug|Cyclophosphamide|Given IV
15888122|NCT03742258|Drug|Doxorubicin Hydrochloride|Given IV
15888123|NCT03742258|Drug|Prednisone|Given PO
15888124|NCT03742258|Biological|Rituximab|Given IV
15888125|NCT03742258|Drug|Spleen Tyrosine Kinase Inhibitor TAK-659|Given PO
15888126|NCT03742258|Drug|Vincristine Sulfate|Given IV
15888127|NCT03742245|Drug|Olaparib|PARP inhibitor
15888128|NCT03742245|Drug|Vorinostat|HDAC inhibitor
15888129|NCT03742232|Drug|PEG3350|"PLENVU® supplied as two powder-for-oral-solution formulations. One formulation contains PEG3350, sodium sulphate and electrolytes, and the second formulation contains PEG3350, sodium ascorbate, ascorbic acid, and electrolytes.
~PLENVU® Administration: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy)."
15888130|NCT03742232|Drug|Macrogol 4000|"SELG-ESSE® supplied as powder-for-oral-solution containing PEG4000, simethicone, sodium sulphate and sodium bicarbonate, and electrolytes.
~SELG-ESSE® Administration: 2-Day Split-Dosing Regimen (to commence in the evening of the day before colonoscopy)."
15888131|NCT03742219|Behavioral|Lifestyle Modification|"Community awareness: a) individuals will be made aware of their own chronic lifestyle diseases and risk factors b) communities will be made aware of their aggregated data concerning chronic lifestyle related diseases and risk factors.
~Education for individuals and communities on the meaning of the lifestyle diseases and risk factors. a) individual and small group sessions explaining diseases and lifestyle measures that are helpful, b) community level education to tentatively include i) shopping guides and recipes, ii) urban gardening projects, iii) puppet shows and other community presentations, iv) literature and posters."
15888132|NCT03742206|Device|Parasacral Transcutaneous Electrical Stimulation|Electrical stimulation with surface electrodes on the sacral roots of S3 that produce inferior urinary tract neuromodulation.
15888133|NCT03742206|Device|Transcutaneous Posterior Tibial Nerve Stimulation|Electrical stimulation with surface electrodes through the activation of peripheral afferent nerves that produce inferior urinary tract neuromodulation
15888134|NCT03742193|Drug|Apatinib|Apatinib 250mg tablet by mouth, bid. 48 hrs break before and 96 hrs after the surgical resection of the pulmonary metastases.
15888135|NCT03742193|Drug|GD regimen|"One cycle: gemcitabine 900 mg/m^2 over 90 min on Day 1, and gemcitabine 900 mg/m^2 and docetaxel 75 mg/m^2 on Day 8. Every 21 days were eligible.
~1~2 -week break before and 2-week break after the surgical resection of the pulmonary metastases is taken."
15888136|NCT03742180|Drug|intranasal dexmedetomidine|The patient will receive intranasal dexmedetomidine in a dose of 1ug.kg-1 in a volume of 1 ml was dripped into both nostrils using a 1-mL syringe, with the patients in the recumbent position plus 1ml sublingual 0.9% saline
15888137|NCT03742180|Drug|sublingual ketorolac|The patient will receive sublingual ketorolac in a dose of 0.5 mg.kg-1 in a volume of 1 ml and 1 ml intranasal saline 0.9%
15888138|NCT03742167|Other|Telemedicine|The mobile, HIPAA-compliant, video-conferencing platform, Zoom Pro, will be used on tablet computers as a low-cost telemedicine platform for the intervention group. This platform uses Wi-Fi or cellular data connection for video streaming. The investigators will use the telephone communication on this platform for control scenarios, to mimic the current standard for audio-only consultation. A web-based software platform (WireCast®) will capture video recordings over a secure wireless network.
15888139|NCT03742154|Drug|Varenicline 0.5 MG|varenicline comes in bottles of 56 - 0.5 mg pills
15888142|NCT03742115|Drug|Etoposide|150 mg/m2 twice weekly for 2 weeks and then weekly
15888143|NCT03742115|Drug|Dexamethasone|initially 10 mg/m2 for 2 weeks followed by 5 mg/m2 for 2 weeks, 2.5 mg/m2 for 2 weeks, 1.25 mg/m2 for one week, and one week of tapering
15888144|NCT03742115|Drug|Etoposide|150 mg/m2 weekly
15888145|NCT03742115|Drug|IVIG|0.5 g/kg, once every 4 weeks
15888152|NCT03742089|Device|Bone Anchored Hearing Surgery|This is a observational study of pediatric patients undergoing bone anchored hearing surgery. The collected will be used to assess the implant stability development of the Ponto BHX implant during up to 24 months after implantation in a pediatric population undergoing BAHS. The study will also monitor the Ponto BHX implant safety and survival throughout the study period.
15888153|NCT03742076|Dietary Supplement|High-dose prebiotic|This is a spray-dried powder, yellowish-white in color, that is dissolvable.
15888154|NCT03742076|Dietary Supplement|Low-dose prebiotic|This is a spray-dried powder, yellowish-white in color, that is dissolvable.
15888155|NCT03742076|Dietary Supplement|Placebo|Powder fiber supplement, yellowish-white in color, that is dissolvable.
15888156|NCT03742063|Drug|first-line chemotherapy|patients who routinely received neoadjuvant chemotherapy according to Peking University People's Hospital chemo-protocols (PKUPH-OS and PKUPH-ES)
15888157|NCT03742050|Procedure|Percutaneous coronary intervention|Percutaneous coronary intervention with drug-eluting stents aiming to achieve complete revascularisation
15888158|NCT03742037|Drug|Cenerimod 0.5 mg|Cenerimod will be supplied as a film-coated tablets at the dose of 0.5 mg
15888161|NCT03742037|Drug|Cenerimod 4 mg|Cenerimod will be supplied as a film-coated tablets at the dose of 4 mg
15888162|NCT03742037|Drug|Placebo|Matching placebo will be supplied as identical film-coated tablets formulated with the same excipients but without the active ingredient, cenerimod
15888163|NCT03741998|Device|Nasopharyngeal airway|THRIVE with a regular nasopharyngeal airway.
15888164|NCT03741985|Behavioral|The handgrip exercise|The control group was given routine dialysis treatment and daily handgrip exercise .Patients are asked to squeeze a rubber ring 30 times per min for altogether 20 minutes on non-dialysis days.The 20-minute exercise can be divided into 3 parts according to individual circumstances.
15888165|NCT03741985|Behavioral|The dumbbell exercise|The experimental group was given routine dialysis treatment and daily dumbbell exercise .Patients are asked to hold 6-pound dumbbells to exercise 30 times per min for altogether 20 minutes on non-dialysis days.The 20-minute exercise can be divided into 3 parts according to individual circumstances.
15888166|NCT03741972|Drug|iSGTL2|Treatment with empaglifozine 10 mg/day (may be also dapaglifozine 10mg/day depending on clinical trial results)
15888167|NCT03741959|Procedure|Experimental group|"Active self-correction exercises (20 minutes) to achieve the best possible trunk alignment the patient can achieve in the three-dimensional planes using visual, proprioceptive and EMG feedbacks.
~Passive and active trunk stabilization exercises (20 minutes) to improve trunk biomechanical constraint Functional tasks (20 minutes) defined as functional exercises to train the automatic response to maintain the best alignment through the broadest possible range of challenging activities (Romano2015)."
15888168|NCT03741959|Procedure|Control group|Training consisted of passive and active trunk mobilization (10 minutes) followed by muscle stretching, and strengthening exercises, and gait training (50 minutes)(Bartolo et. al., 2010).
15888169|NCT03741946|Procedure|Triangle of Sedillot identification using ultrasonography|Contralateral head rotation was done with protractor at angle 30°, 45°, and 60°. The distance and overlap ratio of IJV and CA was calculated in each angle.
15888170|NCT03741933|Drug|Apremilast 30mg|Apremilast 30 mg tablet
15888171|NCT03741920|Device|Personal KinetiGraph™ (PKG™)|"The Personal KinetiGraph™ (PKG™) Movement Recording System was developed by neurologists at the Melbourne-based Florey Institute of Neuroscience and Mental Health. The product is manufactured and marketed by Global Kinetics (GKC).
~The Personal KinetiGraph™ (PKG™) Movement Recording System consists of the following:
~A wrist-worn data logger designed to acquire data on the kinematics of movement disorder symptoms over a 6-10 day period.
~An application to configure the data logger and transfer the acquired data at the end of a recording.
~A series of algorithms that analyze the uploaded data, producing a report that is delivered to the clinician. The report contains objective data distinguishing the movement patterns consistent with tremor, bradykinesia, dyskinesia and immobility."
15888172|NCT03741907|Procedure|FAUCS|extraperitoneal cesarean with a paramedian left section
15888173|NCT03741907|Procedure|MLC|Gold standard
15888174|NCT03741894|Drug|Iodoform|Patients get iodoform (1000 grams containing 350 grams of iodoform, 300 grams of glycerin and 350 grams of alcohol 96%) soaked gauze (steril selvedge gauze bandage 2 cm x 5 m in appropriate length) drainage during suture placements for a week.
15888175|NCT03741894|Other|Wound closure using sutures|Routine primary wound closure with single interrupted sutures (Surgilon 3-0 non-absorbable) only.
15888176|NCT03741894|Drug|Chlorhexidine|Extraction sockets are filled with 1% chlorhexidine gel (Curasept ADS310, Sager Pharma, Sager Dental Kft.,Budapest, Hungary) before suture (Surgilon 3-0 non-absorbable) placements.
15888178|NCT03741855|Device|Cloud Dx Kit with self-monitoring|Patients in this group will be recording their vitals and symptoms with the Cloud DX platform everyday and will be provided with an action-plan that instructs them on what to do in response to their readings.
15888179|NCT03741855|Device|Cloud Dx Kit with remote-monitoring|"Patients in this group will be recording their vitals and symptoms with the Cloud DX platform everyday and will be provided with an action-plan that instructs them on what to do in response to their readings.
~A respiratory therapist (RT) will be monitoring asynchronously patient vitals and contacting them when their vitals exceed pre-determined thresholds.
~The RT will also check on patients once a week irrespective of the value of the vitals."
15888180|NCT03741842|Behavioral|COMBO-KEY|The intervention will last for eight weeks with four home visits and five phone coaching sessions. It will also consist of a 4-item resource package for stroke survivors (including a stroke self-management and self-discovery workbook, a health and life planning toolkit, and videos on sharing of experience by survivors who managed their post-stroke challenges successfully, and a stroke self-management quick reference guide). A telephone hotline for survivors and caregivers to seek information and support related to stroke self-management will also be established. A programme protocol will be developed to ensure the consistent delivery of the programme.
15888181|NCT03741816|Drug|Indirect pulp capping|Indirect pulp capping is a procedure in which a material is placed on a thin partition of remaining carious dentin that, if removed might expose the pulp.
15888182|NCT03741803|Device|Delayed cord clamping|The umbilical cord will be clamped after 60 seconds after birth
15888183|NCT03741803|Device|Early cord clamping|The umbilical cord will be clamped as soon as feasible after birth, usually within the initial 15 seconds after birth.
15888184|NCT03741790|Procedure|Ventilation|The difficult mask ventilation is defined as A) It is not possible for unassisted anesthesiologist to maintain the SpO2 > 90% using 100% oxygen and positive pressure mask ventilation in a patient whose SpO2 > 90% before anesthetic intervention; and/or B) It is not possible for unassisted anesthesiologist to prevent or reverse signs of inadequate ventilation during positive mask ventilation.
15888185|NCT03741790|Procedure|Intubation|"The difficult endotracheal intubation is defined as  It is not possible to visualize any portion of the vocal cords with conventional laryngoscopy or when proper insertion of the endotracheal tube with conventional laryngoscopy requires more than three attempts or more than ten minutes."
15888186|NCT03741777|Other|Clear oral fluid|clear oral fluid including water, pulp-free juice and tea or coffee without milk.
15888187|NCT03741764|Device|Vivosorb|Resorbable implant device
15888188|NCT03741751|Device|rTMS|Participants will receive either active or sham bilateral rTMS over the dorsolateral prefrontal cortex (DLPFC) for 12.5 min per side.
15888189|NCT03741751|Behavioral|Computerized cognitive training|All participants will receive computerized cognitive training for 40 min after each rTMS session.
15888190|NCT03741725|Other|Pay-it-forward|Participants will be offered a gift of free gonorrhea and chlamydia testing made available by donations from previous testers, and asked whether they would like to donate money (pay-it-forward) for future men to receive the same option.
15888191|NCT03741725|Other|Pay-what-you-want|Participants will be offered gonorrhoea and chlamydia testing and told that they can decide and pay any desired amount after receiving the test.
15888192|NCT03741712|Drug|SHR3680|Tablet. Specifications of 80mg
15888193|NCT03741712|Drug|SHR2554|Tablet. Specifications of 50mg and 200mg
15888194|NCT03741699|Drug|Pre-treatment with rLH (Luveris 75 IU),|Treatment with 150 IU/day rLH (Luveris 75 IU), administered subcutaneously for 4 consecutive days prior to COS (Controlled ovarian stimulation)
15888195|NCT03741686|Dietary Supplement|konjac glucomannan|Konjac-mannan fiber-enriched biscuits (0.5 g/412KJ [100kcal] of glucommanan)
15888196|NCT03741686|Dietary Supplement|wheat bran|Wheat bran (hard red wheat bran) fiber enriched biscuits
15888197|NCT03741673|Other|Quality-of-Life Assessment|Ancillary studies
15888198|NCT03741673|Other|Questionnaire Administration|Ancillary studies
15888199|NCT03741673|Radiation|Stereotactic Radiosurgery|Undergo SRS
15888200|NCT03741660|Dietary Supplement|konjac glucomannan|Konjac-mannan fiber-enriched biscuits (0.7 g/412KJ [100kcal] of glucommanan)
15888201|NCT03741660|Dietary Supplement|wheat bran|Wheat bran (hard red wheat bran) fiber enriched biscuits
15888202|NCT03741647|Diagnostic Test|sleep study and blood sample|full night polysomnographic study and blood sample to detect some genetic issues
15888203|NCT03741634|Other|Multi-sectoral agricultural intervention|Adult participants in the intervention arm receive a loan (~$175) from a well-established Kenyan bank used to get a human-powered water pump, seeds, fertilizers and, pesticides, and education in financial management and sustainable farming practices.
15888204|NCT03741621|Dietary Supplement|Viscous Fibre Blend|High viscosity viscous fiber blend sprinkled on wheat and maize bran cereals(Bran Buds®; Kellogg Company)
15888205|NCT03741621|Dietary Supplement|Psyllium|Bran Buds cereal (white bran and maize bran) with psyllium (Bran Buds® with PSY; Kellogg Company)
15888206|NCT03741621|Dietary Supplement|Wheat Bran|All Bran cereal (All Bran®; Kellogg Company)
15888207|NCT03741608|Behavioral|High blood pressure management education|The 7-part education series includes 5 sessions focused on mindfulness and breathing techniques for stress reduction. One session will focus on choosing healthy, low salt foods and will provide resources for smoking cessation. The final session will include a grocery store tour to teach participants how to read food labels and to purchase healthy food.
15888208|NCT03741608|Behavioral|Home blood pressure measurement|Participants will be taught to use an automated blood pressure cuff and will be asked to provide monthly blood pressure readings to study staff.
15888209|NCT03741595|Behavioral|Item spacing|Spatial proximity of items to one another
15888210|NCT03741582|Other|TransMiCable|"TransMiCable will have one service line 3.43 km-long with four stations (El Tunal , Juan Pablo II , Manitas , and Paraiso, see highlighted stops in Figure 2). El Tunal is the station that connects to the city's bus rapid transit system. The planned capacity of TransMiCable is 3,600 persons per hour in 163 cabins or gondolas. Each cabin fits ten passengers, with space for wheelchairs and bicycles and will be equipped with free Wi-Fi. The expected travel time reductions from each station to portal El Tunal, through the shortest pathway, are: 26 minutes saved from Juan Pablo II station-from 32 to 6 minutes; 31 minutes saved from Manitas station-from 38 to 7 minutes and 49 minutes saved from Paraiso station-from 62 to 13 minutes 22. In conjunction with TransMiCable, urban projects will be implemented including the construction of parks, outdoor gyms, sport courts, community centers for children and older adults, a market, an administrative, and a tourism offices."
15888211|NCT03741569|Device|Transabdominal Fetal Heart Rate|"Doppler, ECG and acoustic sensors will be placed on the mother's abdomen to capture the heart rate of the fetus and mother as well as uterine contractions.
~For each of the participants, we will make two 15-minute recordings: one with conventional ECG electrodes and one with ECG textile electrodes"
15888212|NCT03741556|Other|questionaire|a questionaire is sent to each participans
15888213|NCT03741543|Other|A 12-week health promotion course|The Health Promotion intervention consists of 12 weekly 2-hour sessions with a group of up to six participants and two course facilitators. Teaching methods includes lecture, questions- and answer periods, and interactive hands-on learning. During the class sessions, the facilitators encourages the participants to ask questions and make comments about the lecture at any time. During the first class session, each participant receives a booklet with the course material.
15888214|NCT03741530|Drug|Glibenclamide Tablets|Giving glibenclamide tablets, 1.25 mg 3 times daily, orally or through gastric tube, for 7 consecutive days after enrollment.
15888215|NCT03741530|Other|Standard management for ICH|Usual care and drug in hospital
15888216|NCT03741517|Radiation|18F-FDG-PET|Fludeoxyglucose F18
15888217|NCT03741517|Radiation|68Ga-DOTATOC-PET|DOTA-tyr3-Octreotide Ga68
15888218|NCT03741517|Radiation|Computed tomography|Computed tomography of thorax and abdomen with 3-phase contrast
15888219|NCT03741517|Other|Core needle biopsy|Core needle biopsy of metastatic lesions
15888220|NCT03741517|Other|Phlebotomy|Phlebotomy from peripheral vein
15888221|NCT03741504|Procedure|micro-osteoperforations (MOPs)|three (3) micro-osteoperforations (MOPs) in the cortical and medullar bone, distal to the upper canine. These MOPs will be at the apical, medial and gingival zone of the bone located at the distal surface of the canine in the buccal and in the palatal side. The deep of the MOPs will be at 6 mm. It is going to be done with a PROPEL
15888222|NCT03741478|Drug|OLANZapine 2.5 MG|"Olanzapine capsules (2.5mg) will be administered with the following dosing schedules for each arm:
~Metabolic arm - 5mg on Day 0, 7.5mg on Day 1, and 10mg on Day 2
~Cognitive arm - 5mg on Day 0, 10mg on Day 1"
15888223|NCT03741478|Drug|Placebo|Placebo capsules visually identical to those containing olanzapine will be administered according to the same dosing schedule for each arm.
15888254|NCT03741257|Drug|Hypertonic saline|resuscitation fluid
15888390|NCT03740152|Device|Transcranial Light Therapy|Device: LiteCure® The PhotoBioModulation-1000 (TPBM-1000)
15888572|NCT03738813|Device|Gloreha Aria|Device offers specific programs that help patients to move arm, wrist and fingers
15888224|NCT03741478|Drug|Insulin Lispro 100 UNT/ML|"Intranasal insulin spray (or placebo) will be administered on day 2 for each arm.
~For the metabolic arm: 40 IU of intranasal insulin lispro will be administered at timepoint 0 during the pancreatic euglycemic clamp procedure.
~For the cognitive arm: 160 IU of intranasal insulin lispro will be administered at about 11 am on day 2 prior to the MRI imaging and cognitive testing procedures."
15888225|NCT03741478|Other|Saline|Placebo saline spray visually identical to the intranasal insulin spray will be administered on day 2 for each arm according the same dosing schedules.
15888226|NCT03741465|Procedure|The SFP technique|The USG, and the 5-point NRS evaluation in the SFP
15888227|NCT03741465|Procedure|The ASP technique|The USG, and the 5-point NRS evaluation in the ASP
15888228|NCT03741452|Other|transversalis fascia plane block|patient controlled analgesia devices with tramadol
15888229|NCT03741439|Device|Treatment|Low intensity shockwave treatment in patients with mild/moderate ED using a electromagnetic emitter
15888230|NCT03741439|Device|Sham|Sham treatment
15888231|NCT03741426|Drug|Olaparib|Olaparib 300mg twice daily, oral medication administered for at least 2 weeks and up until the morning of nephrectomy. Arms 2, 3 and 5
15888232|NCT03741426|Drug|Cediranib|Cediranib 20mg once daily, oral medication administered for at least 2 weeks until 36 hours prior to nephrectomy. Arms 1 and 3
15888233|NCT03741426|Drug|Durvalumab|Durvalumab 1500mg intravenous infusion administered once, no greater than 4 weeks prior to nephrectomy
15888234|NCT03741413|Other|Gain-frame SMS|Emergency recruitment cell phone short messages that emphasizing donating blood can save patients' lives were sent to donors in this group.
15888235|NCT03741413|Other|Loss-frame SMS|Emergency recruitment cell phone short messages emphasizing that donating blood can prevent patients from death were sent to donors in this group.
15888236|NCT03741413|Other|Control SMS|Emergency recruitment cell phone short messages that only mentioning the low Rh-negative blood stockpile were sent to donors in this group.
15888237|NCT03741400|Device|Neofect RAPAEL Smart Glove|The Neofect Rapael Smart Glove is a biofeedback system designed for upper extremity rehabilitation in stroke survivors. It includes a glove-shaped sensor device and a software application.
15888238|NCT03741387|Other|Gain-frame questionnaire|Questionnaires focusing on the attitude of saving patients' lives were given to Rh negative blood donors in this group.
15888239|NCT03741387|Other|Loss-frame questionnaire|Questionnaires focusing on the attitude of preventing patients from death were given to Rh negative blood donors in this group.
15888240|NCT03741374|Procedure|Minimally-invasive non-surgical therapy (MINST)|A non-surgical minimally-invasive treatment protocol, named MINST, has been proposed (Ribeiro et al. 2011) for the treatment of periodontitis, in order to minimise patient discomfort and maximise the healing potential. This technique usually involve the use of magnification lenses or microscopes and small instruments which would reduce the risk of tissue trauma compared with traditional instruments.
15888241|NCT03741361|Other|anxiety and depression|Female patients who have a previous history of surgery or infertility, or a history of miscarriage or abortion are often susceptible to preoperative anxiety or depression. We will observe the effect of anxiety and depression on the dosage of propofol during induction.
15888242|NCT03741348|Procedure|Erector Spinae Plane Block|In (ES) group After skin sterilization, ESPB was performed in sitting position at the level of T9 linear ultrasound (US) transducer (Phillips-Saronno Italy) was placed vertically 3cm lateral to midline to visualize the muscles of the back, transverse process and simmering pleura in between the two transverse processes. After local infiltration of needle insertion site with 2-3ml of 2% lidocaine, a 22-gauge Short bevel needle (Spinocan, B.Braun Melsungen AG, Germany) was inserted in cranial-caudal direction towards transverse process (TP) in-plane to the US transducer until needle touched the TP crossing all the muscles. Then, up to 20 ml of bupivacaine 0.5% was injected. The procedure was repeated following the same steps on the other side of back.
15888243|NCT03741348|Procedure|control|in control group, Erector Spinae Plane Block will not be done
15888244|NCT03741335|Other|Resistance Training|Participants attend supervised, group-based moderate-intensity strength training program 3 times per week for 60 minutes per session.
15888245|NCT03741335|Other|Stretching|Participants attend a supervised, group-based supervised flexibility program 3 times per week for 60 minutes per session
15888246|NCT03741335|Other|Tai Chi|Participants attend a supervised, group-based tai ji quan program where they perform an integrated exercise routine consisting of 8 purposeful movement forms and a set of therapeutic movements 3 times per week for 60 minutes per session.
15888247|NCT03741309|Other|5% fluorocalcium phosphosilicate dentifrice|dentifrice containing 5% fluorocalcium phosphosilicate and VAS score assessed at Baseline, 2 weeks, 6 weeks.
15888248|NCT03741309|Other|Calcium sodium phosphosilicate|Calcium sodium phosphosilicatand VAS score assessed at Baseline, 2weeks, 6 weeks.
15888249|NCT03741309|Other|Placebo dentrifice|placebo dentifrice and VAS score assessed at Baseline, 2weeks, 6 weeks.
15888250|NCT03741296|Procedure|Single stage revision|One-stage exchange hip joint replacement surgery
15888251|NCT03741296|Procedure|Two-stage revision|Two-stage exchange hip joint replacement surgery
15888252|NCT03741283|Other|Optimisation of nutrition and medication|"Inter-professional optimisation of medication prescribing:
~Study participants in the intervention group receives optimisation of medication prescribing at admission day (baseline) regardless of nutritional state. The intervention is performed in cooperation between a clinical pharmacist and a medical physician.
~Nutritional intervention:
~If positive screening for malnutrition or risk of malnutrition a dietetic intervention is initiated and if positive screening below interventions are initiated:
~Dysphagia: occupational therapy intervention.
~Oral cavity problems: odontological intervention.
~Depression: geriatric intervention.
~Low ADL: occupational therapy intervention and if positive screening for poor muscle strength: physiotherapeutic intervention."
15888253|NCT03741270|Biological|Rabivax-S|Rabivax-S is a lyophilized vaccine manufactured by Serum Institute of India Pvt. Ltd. containing inactivated purified rabies antigen (Pitman Moore, PM3218 as virus strain) produced using Vero ATCC CCL 81 cells. The diluent (sterile water for injection) is provided in a separate 1 mL ampoule. After reconstitution, a single dose of 1 mL contains an inactivated, purified rabies antigen (not less than 2.5 IU), glycine (40 mg), sucrose (40 mg) and human serum albumin (25% 10 mg). The intervention is administered by intramuscular injection of 1 mL reconstituted vaccine in the deltoid area of the upper arm, on days 0, 7 and 21 (or 28).
15888255|NCT03741244|Drug|apatinib|Apatinib is an oral small molecule antiangiogenic targeted drug developed in China. More and more studies found that antiangiogenic drugs have outstanding performance in treating glioma. From the perspective of clinical and molecular mechanism, the combination of Temozolomide and apatinib may have synergistic effect especially to TMZ insensitivity patients(MGMT gene promoter unmethylated) and poor prognosis (IDH1 wild type) population
15888256|NCT03741244|Drug|Temozolomide|Temozolomide，alkylating agent， is the standard first-line chemotherapy of glioma.
15888257|NCT03741218|Other|Freeze-dried grape (GRAP)/Placebo (PLA)|The subjects will receive, after overnight fasting, either a monodose of freeze-dried grapes (equivalent to 300 g of fresh grapes) or isocaloric placebo solved in water, together with a high-fat breakfast. Blood samples will be collected before the intake, up to 5 h after breakfast, then a medium-fat lunch will be provided and blood samples will be collected for three additional hours. A total of 10 samples will be collected: 0-30-60-120-180-240-300-330-360-420 min. Both interventions will be separated by two weeks. Subjects will be instructed not to modify their dietary habits during the development of the study, but during the 72 h before each visit they will have to restrict the intake of polyphenol-rich foods (a detailed list will be provided).
15888258|NCT03741205|Device|SPEAC System|Surface Electromyography (sEMG) based seizure monitoring and alerting system
15888259|NCT03741192|Device|SPEAC System|Surface Electromyography (sEMG) based seizure monitoring and alerting system
15888260|NCT03741179|Drug|ASA-withdrawn group|Patients whith sFlt/PlGF ratio < 38 at 24+0-27+6 weeks will be randomized into two arms of the trial. Patients allocated in the experimental arm will stop the ASA treatment.
15888261|NCT03741166|Other|Blood Sample Collection|Subjects participating in the study will have blood drawn at enrollment.
15888262|NCT03741153|Device|slit lamp|"Presence of white grayish exfoliation material on the anterior lens capsule and / or the pupillary margin.
~Poor pupillary dilatation due to atrophy of the dilator pupillae muscle.
~The presence of pseudoexfoliative material (PXF)in cilliary processes and zonules.
~presence of PXF material scattered on corneal endothelium.
~Flecks of the exfoliative material on the anterior chamber which leads to glaucoma."
15888263|NCT03741140|Diagnostic Test|Motivation tests|Motivation tests will characterize elementary deficits of motivation
15888264|NCT03741127|Drug|Rimiducid may be administered as indicated|Patients who received P-BCMA-101 in a previous trial will be evaluated in this trial for long term safety and efficacy. Rimiducid (safety switch activator) may be administered as indicated.
15888265|NCT03741114|Procedure|Foley's Catheter|patients managed by Intrauterine Inflated Foley's Catheter Balloon after delivery of the fetus.
15888266|NCT03741114|Drug|TA|patients received 1 gm tranexamic acid intravenous just before skin incision in 100 ml saline
15888267|NCT03741114|Drug|Placebo|patients received 100 ml saline just before skin incision
15888268|NCT03741101|Drug|Trametinib|treatment
15888269|NCT03741088|Device|VORTX Rx treatment|Cavitation-based cellular destruction using focused ultrasound
15888270|NCT03741075|Procedure|BUA|bilateral uterine artery ligation (BUAL) after delivery of the fetus which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures
15888271|NCT03741075|Drug|topical tranexamic acid|topical application of 200ml saline contains 2 gm tranexamic acid to the placental bed after delivery of the fetus which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures
15888272|NCT03741075|Drug|placebo|topical application of 200ml saline to the placental bed after delivery of the fetus which not respond uterotonic and simple hemostatic maneuvers like placental bed hemostatic sutures
15888273|NCT03741062|Device|J. Morita AdvErl Evo Er:YAG laser|"Er:YAG laser perimeters:
~Energy = 80 mJ Pulse Rate = 25 Hz Duration = 30 s"
15888274|NCT03741062|Device|Control|Sham treatment with laser unit turned off
15888275|NCT03741049|Device|Scalpel Bougie technique (plastic laryngeal model)|ScalpelBougie Set
15888276|NCT03741049|Device|Seldinger technique (plastic laryngeal model)|Melker Set
15888277|NCT03741049|Device|Surgical technique (plastic laryngeal model)|Scalpel and speculum
15888278|NCT03741049|Device|Scalpel Bougie technique (porcine laryngeal model)|ScalpelCric Set
15888279|NCT03741049|Device|Surgical technique (porcine laryngeal model)|Scalpel and speculum
15888280|NCT03741036|Procedure|Autogenous bone graft as space filling in immidiate implant placment|"The selected patients will be informed of the nature of the research work and informed consent will be obtained (immediate implant placement grafting with autogenous bone graft)
~Patients will be subjected to CBCT (diagnostic for upper arch).
~Local anesthesia will be given to the patient.
~Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures.
~The procedure will be carried out flapless.
~In the study group: Atraumatic extraction
~The extraction socket will be evaluated for absence of any fenestration or granulation tissues"
15888281|NCT03741036|Procedure|Deprotinized bovien as space filling in immidate implant placement|"The selected patients will be informed of the nature of the research work and informed consent will be obtained (immediate implant placement grafting with deprotinized bovien material)
~Patients will be subjected to CBCT (diagnostic for upper arch).
~Local anesthesia will be given to the patient.
~Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures.
~The procedure will be carried out flapless.
~In the study group: Atraumatic extraction
~The extraction socket will be evaluated for absence of any fenestration or granulation tissues"
15888282|NCT03741036|Procedure|Nano-hydroxiapatite alloplast in immidiate implant placement|"The selected patients will be informed of the nature of the research work and informed consent will be obtained (immediate implant placement grafting with nano-hydroxiapatite alloplast material )
~Patients will be subjected to CBCT (diagnostic for upper arch).
~Local anesthesia will be given to the patient.
~Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures.
~The procedure will be carried out flapless.
~In the study group: Atraumatic extraction
~The extraction socket will be evaluated for absence of any fenestration or granulation tissues"
15888283|NCT03741023|Procedure|Blood draw (venipuncture or fingerstick)|Blood will be drawn from participants by venipuncture and/or by fingerstick. Finger sticks will not be collected in the pediatric population.
15888284|NCT03740997|Drug|Optison|Optison is administered intravenously
15888352|NCT03740438|Diagnostic Test|Hemoglobin concentration|Perioperative hemogloin concentration
15888285|NCT03740984|Other|Interventions are self controlled by the patient via a mp3 player and noise reduction headphones.|During premedication and during chemotherapy the patient is connected to a long term ECG recording and allowed to listen to the mp3 Player via noise reduction headphones.
15888286|NCT03740971|Device|Remote Ischemic Conditioning treatment|Remote Ischemic Conditioning is given twice a day with 200mmHg pressure.
15888287|NCT03740971|Drug|Guideline-based therapy|Guideline-based therapy
15888288|NCT03740958|Drug|rt-PA|Intravenous throbolysis with 0.9mg/kg rtPA
15888289|NCT03740958|Drug|Argatroban|100 ug/kg bolus over 3 to 5 minutes was administered intravenously, followed by a continuous Argatroban infusion of 1.0 ug/kg per minute for 48 hours adjusted to a target activated partial thromboplastin time of 1.75 X baseline (about 10%)
15888290|NCT03740945|Drug|Placebo|Daily administration of one placebo vaginal ovule at bedtime
15888291|NCT03740945|Drug|Prasterone (DHEA)|Daily administration of one prasterone vaginal ovule at bedtime
15888292|NCT03740932|Diagnostic Test|Study group (group A)|"Maximal vertical mouth opening (MIO):
~From sitting position, with the use of the calliper, the distance between the incisal edges along the midline of the upper and lower central incisors without pain was measured, by placing one end of the poley gauge against the incisal edge of one of the upper central incisors, and the other end against the incisal edge of the opposing lower incisor.
~The distance recorded in millimetres, the subjects was instructed to open your mouth as wide as possible without causing pain or discomfort. The poley gauge was sterilized with antiseptic solution before and after each measure"
15888293|NCT03740919|Drug|LY900014|Administered SC
15888294|NCT03740919|Drug|Insulin Lispro|Administered SC
15888295|NCT03740893|Drug|AZD6738|"PART 1: Pre-operative exposure of 160mg AZD6738 to be administered orally twice daily on Days 5 -14 of the WOP.
~PART 2: 12 months post-operative exposure to 160mg AZD6738 to be administered orally twice daily on Days 1 - 14 of a 28 day cycle."
15888296|NCT03740893|Drug|Olaparib|"PART 1: Pre-operative exposure to 300mg of olaparib to be administered orally twice daily on Days 1-14 of the WOP.
~PART 2: 12 months post-operative exposure to 300mg olaparib (2 x 150mg tablets) to be administered orally twice daily on a continuous schedule Day 1-28 of a 28 day cycle."
15888297|NCT03740893|Drug|Durvalumab|"PART 1: Pre-operative exposure to 1500mg durvalumab to be administered via intravenous (IV) infusion on Day 1 only of the WOP.
~PART 2: 12 months post-operative exposure to 1500mg durvalumab to be administered via intravenous (IV) infusion on Day 1 only of a 28 day cycle."
15888298|NCT03740880|Other|Dual trigger|dual trigger: 10.000 IU hCG i.m. and 0.3 mg Deca
15888299|NCT03740867|Other|Pulmonary rehabilitation|Exercise program includes aerobic (walking band, bicycle, arm ergometer) and strengthening (with free weights) components.
15888300|NCT03740854|Other|Pressure Controlled Ventilation|Patients will be ventilated with a pressure level which supplies a tidal volume corresponding 8ml/kg, 12 breaths per minute, 1/2 inspiration/expiration ratio and %40 Fraction of Inspired Oxygen . These ventilator settings can be changed in order to adjust end tidal carbon dioxide and oxygen saturation levels.
15888301|NCT03740854|Other|Volume Controlled Ventilation|Patients will be ventilated with a tidal volume which corresponds 8ml/kg, 12 breaths per minute, 1/2 inspirastion/expiration ratio and %40 Fraction of Inspired Oxygen . These ventilator settings can be changed in order to adjust end tidal carbon dioxide and oxygen saturation levels.
15888302|NCT03740841|Behavioral|Interactive story teller LUNII|Use of the interactive story teller LUNII by the child from the pre-operative visit to the discharge.
15888303|NCT03740828|Device|KIDScore D3|Embryos are scored using the KIDScore D3 algorithm based on annotated morphokinetic parameters.
15888304|NCT03740815|Procedure|Serratus plane block|Ultrasound guided injection of local anesthetic between latissimus dorsi and serratus muscles at mid axillary line.
15888305|NCT03740815|Procedure|Axillary dissection|Axillary dissection is a surgical procedure that incises the axilla to identify, examine, or remove lymph nodes.
15888306|NCT03740815|Procedure|Intravenous sedation|Administration of sedatives thru an intravenous access to achieve relaxion and improve operative conditions.
15888307|NCT03740763|Device|Spinal Cord Stimulation (SCS)|SCS for treatment of neuropathic pain
15888308|NCT03740763|Other|Physiotherapy|Physiotherapy 2 hours/week with physiotherapist and physical activity counseling for treatment of neuropathic pain
15888309|NCT03740750|Device|Thermacare heat wraps|low level continuous heat wrap
15888310|NCT03740750|Device|TENS|electrical stimulation
15888311|NCT03740750|Device|sham heat|expended heat wrap
15888312|NCT03740750|Device|sham Tens|tens applied but unit not turned on
15888315|NCT03740724|Genetic|FCX-013|FCX-013 is a genetically modified cell product obtained from the subject's own skin cells (autologous fibroblasts). The cells are expanded and genetically modified to express metalloproteinase-1 (MMP-1) under the control of a RheoSwitch (RTS®) system. FCX-013 cell suspension is injected intradermally.
15888316|NCT03740724|Drug|veledimex|Veledimex, is a small molecule which activates the RTS to induce expression of MMP-1 and is and provided as a liquid filled gelatin capsule for oral administration
15888317|NCT03740711|Procedure|Left atrial venting|The contralateral femoral vein is assessed with an 7-French(Fr) sheath() and femoral artery is assessed with 5-Fr sheath( ) for fluoroscopic guidance using 5-Fr pig-tail catheter. In some cases trans-esophageal echo is used. The inter-atrial septum in punctured with a standard BRK™tran-septal needle(St. Jude Medical Inc., St. Paul, MN) under direct visualization via an 8-Fr Mullin sheath(St. Jude Medical Inc.). A SAFARI™(Boston Scientific, Galway, Ireland) guidewire is advanced into the LA. An 8-Fr Mullin-sheath is removed and atrial septostomy is performed using 21-Fr dilator. A 17-Fr or 21-Fr Biomedicus Percutaneous Femoral cannula(Medtronic Inc., Minneapolis, MN) is then placed in the LA and was attached to the ECMO circuit using a Y connector.
15888353|NCT03740425|Procedure|Blood Transfusion|Blood Transfusion in patients who underwent transcatheter aortic valve implantation (TAVI)
15888391|NCT03740139|Other|The Police-Mental Health Linkage System|When, during an encounter, the police officer decides to call the number provided in the notice, the Linkage Specialist (a licensed mental health provider from the mental health service where the subject was recruited, who has access to the clinic's EMR) can provide telephonic support to the officer.
15888573|NCT03738813|Other|Usual care|Conventional occupational therapy
15888318|NCT03740698|Device|BiAP|The bio-inspired artificial pancreas (BiAP) system uses a control algorithm based on a mathematical model of beta-cell behaviour derived from physiological experiments, carried out by other groups, which have demonstrated how the beta cells in the pancreas produce insulin in people without diabetes. Utilising the data from these experiments it has been possible to implement the behaviour of the beta cell in software and we have used a simulator with 200 virtual patients to demonstrate the safety and efficacy of the algorithm. The data from the simulator have previously been published. The BiAP algorithm is implemented on a miniature silicon microchip within a portable handheld device, which interfaces the components of the artificial pancreas.
15888319|NCT03740698|Device|ABC4D|The Advanced Bolus Calculator for Diabetes (ABC4D) is a novel, adaptive decision support algorithm based on case-based reasoning (CBR) providing real-time insulin advice through a smartphone application.
15888320|NCT03740685|Diagnostic Test|High sesitive C reactive protien|High sesitive C reactive protien will be evaluated at admission time and after 36 hours
15888321|NCT03740659|Drug|Levofloxacin + Dexamethasone|Levofloxacin + Dexamethasone ophthalmic solution + dexamethasone 21-phosphate administered twice: 90(±15) min. and 60(±15) min. before limbal paracentesis.
15888322|NCT03740659|Drug|Levofloxacin|Levofloxacin ophthalmic solution (Oftaquix®) administered twice: 90 (±15) min. and 60 (±15) min. before limbal paracentesis).
15888323|NCT03740659|Drug|Dexamethasone|Dexamethasone ophthalmic solution (Tamesad®) administered twice: 90 (±15) min. and 60 (±15) min. before Limbal paracentesis.
15888324|NCT03740633|Behavioral|passive ankle pump motions on the day of surgery|Passive ankle pump motions include flexion and extension, circumduction, which will be conducted by caregiver on the day of surgery.
15888325|NCT03740633|Behavioral|active ankle pump motions and abdominal breathing training on the 1-3 day after the surgery|Active ankle pump motions include flexion and extension, circumduction, which will be conducted by patient on the 1-3 day after the surgery. On the same time, the patient is given abdominal breathing training.
15888326|NCT03740633|Combination Product|Regular care|Regular post-operative care consists of compression stockings, anticoagulant and instructions of early mobilization
15888327|NCT03740620|Procedure|Bevel facing the cephalad direction of the patient|The bevel of the nasotracheal tube facing cephalad direction of the patient
15888328|NCT03740620|Procedure|Bevel facing leftward of the patient|The bevel of the nasotracheal tube facing the left side of the patient
15888329|NCT03740607|Device|Virtual reality|Healthcare virtual reality software implemented during peripheral intravenous catheter placement
15888330|NCT03740607|Procedure|Peripheral intravenous catheter placement|Peripheral intravenous catheters are placed in the peri-operative suites in preparation for anesthesia during surgery.
15888331|NCT03740594|Behavioral|KMC|Neonates were subjected to either daily KMC for 60 minutes, daily KMC for 120 minutes or conventional care (controls) for at least 7 days.
15888332|NCT03740581|Drug|Insulin|Basal Bolus regimen (Participant to receive, Insulin >= 3 times per day)
15888333|NCT03740568|Drug|Low Progesterone|"Additional daily dosage of subcutaneous progesterone (Psc) 25 mg/day at night since D4 (vaginal micronized P 200mg/200mg/200mg + Psc 25 mg/night) New Progesterone analysis on D5 before warming the embryo. Group 2a (Canceled Group, P on D5 <10.64 ng/mL): cancel PGT-FET. Scheduling a new procedure under different P supplementation.
~Group 2b (Restored Progesterone Group, P on D5 >10.64 ng/mL): continue HRT as previously described (vaginal micronized P 200mg/200mg/200mg + Psc 25 mg/night). Warming and transfer the same day (D5)
~Beta-hCG and P analysis is performed on the 14th day of P supplementation (D14). In case of positive Beta-hCG analysis:
~If P is >10.64 ng /mL: the same P supplementation is continued. If P is <10.64 ng /mL: an additional dosage of vaginal micronized P (200 mg) is added at night"
15888334|NCT03740568|Drug|Normal Progesterone|"Same Progesterone supplementation (vaginal micronized P 200mg/200mg/200mg) Warming and transfer on D5
~Beta-hCG and P analysis is performed on the 14th day of P supplementation (D14). In case of positive Beta-hCG analysis:
~If P is >10.64 ng /mL: the same P supplementation is continued. If P is <10.64 ng /mL: an additional dosage of vaginal micronized P (200 mg) is added at night"
15888335|NCT03740555|Drug|HNC042 single dose|HNC042,freeze-dried powder,single ascending doses Single dose, Intravenous route,starting dose of 100mg escalating up to 1200mg
15888336|NCT03740555|Drug|Placebo single dose|Placebo single ascending doses , Intravenous route Single dose, matching placebo
15888337|NCT03740555|Drug|HNC042 multiple ascending doses|HNC042,freeze-dried powder,multiple ascending doses, Intravenous route Multiple doses, daily for 7 days, anticipated doses: 300mg to 1200mg
15888338|NCT03740555|Drug|Placebo multiple ascending doses|Placebo, multiple ascending doses, Intravenous route, Multiple doses, daily for 7 days, matching placebo
15888339|NCT03740542|Procedure|Esophagectomy|Surgical removal of part of esophagus
15888340|NCT03740542|Procedure|Pyloroplasty|pyloric drainage procedure
15888341|NCT03740529|Drug|LOXO-305|Oral LOXO-305
15888342|NCT03740529|Drug|Venetoclax|Oral
15888343|NCT03740529|Drug|Rituximab|IV
15888344|NCT03740516|Drug|CC-10004|CC-10004 will be administered orally
15888345|NCT03740490|Combination Product|Smart-T + NRT|Smart-Treatment App and Nicotine Replacement Therapy
15888346|NCT03740490|Combination Product|QuitGuide + NRT|NCI QuitGuide Treatment App and Nicotine Replacement Therapy
15888347|NCT03740477|Diagnostic Test|ECG|Eligible participants will receive a 30-second ECG recording during their visit at the Absentee Shawnee Tribal clinic
15888348|NCT03740464|Drug|long-acting granulocyte colony stimulating factor|A 6 mg of polyethylene glycol granulocyte colony stimulating factor will be given to patients of study group
15888349|NCT03740464|Drug|Short-term granulocyte colony stimulating factor|Short-term granulocyte colony stimulating factor will be given to all patients according to the severity of myelosuppression
15888350|NCT03740451|Other|Active mobilization of soft tissues|This study will compare the effects of joint passive mobilization with the effects of soft tissue active mobilization on heart rate variability (as an indicator of autonomous regulation), psychological well-being (measured by the Ryff scale) and pain in patients with fibromyalgia.
15888351|NCT03740451|Other|Passive mobilization|This study will compare the effects of joint passive mobilization with the effects of soft tissue active mobilization on heart rate variability (as an indicator of autonomous regulation), psychological well-being (measured by the Ryff scale) and pain in patients with fibromyalgia.
15888354|NCT03740412|Behavioral|Sedentary behaviour reduction using motivational interviewing, education, individualised feedback, goal-setting, self-monitoring, environmental modification, and supportive phone calls|The intervention has multiple components in order to reduce sedentary behaviour, namely: incorporating individualised feedback on sitting time, education about sedentary behaviour, individualised goal-setting and environmental modification according to each participant's own behavioural patterns and capabilities, motivational interviewing, and biweekly phone calls.
15888355|NCT03740399|Procedure|spinal anesthesia|Investigators will perform spinal anesthesia for section
15888356|NCT03740386|Drug|Phentolamine Mesylate 0.235 MG/ML [OraVerse]|compare effect of phentolamine mesylate in three arms
15888357|NCT03740373|Drug|BGF MDI (budesonide, glycopyrronium and formoterol fumarate) with 10 s breath hold|Participants will receive a single dose of BGF MDI; the dose will be administered with a 10 s breath-hold.
15888358|NCT03740373|Drug|BGF MDI ((budesonide, glycopyrronium and formoterol fumarate) with 3 s breath hold|Participants will receive a single dose of BGF MDI; the dose will be administered with a 3 s breath-hold.
15888359|NCT03740347|Behavioral|Questionnaires|"Response to questionnaires evaluating chronic pain and its repercussion :
~anxiety questionnaire (Revised Children's Manifest Anxiety Scale),
~depression questionnaire (Children's Depression Inventory score),
~sleepiness questionnaire (Pediatric Daytime Sleepiness Scale),
~quality of life questionnaire (Pediatric Quality of Life inventory score)."
15888360|NCT03740334|Drug|Ribociclib|Ribociclib, blocks a specific type of protein called a cyclin-dependent kinases (CDK)
15888361|NCT03740334|Drug|Dexamethasone|Corticosteroids are commonly used to treat ALL.
15888362|NCT03740334|Drug|Everolimus|Everolimus is an inhibitor of mTOR. mTOR inhibition blocks the translation of genes that regulate cancer cell proliferation
15888363|NCT03740321|Device|Embolization with tri-acryl gelatin (Embosphere) particles|Left, right and posterior branches of superior rectal artery will be embolized with tri-acryl gelatin particles in 500-700 and 700-900 micrometers in size until homeostasis will be achieved.
15888364|NCT03740308|Device|Locally Made Zirconia Crowns|Occlusal reduction by decreasing the occlusal surface to less than the natural occlusal profile by about 1-1.5 mm roughly. Proximal reduction by unfastening the interproximal contacts. The tooth should be trimmed down circumferentially by around 0.5-1.25 mm as needed. Subgingival reduction, leaving no undercuts or subgingival ridges, about 1-2 mm subgingivally on every area should be prepared. Completion of the preparation by eliminating sharp lines and pointed angles to allow all prepared areas to be marginally rounded and smoothed. Locally Made Zirconia Crowns are fixed using Glass Ionomer cement (Fuji- Jaban).
15888365|NCT03740308|Device|ZR Zirconia Crwons NuSmile ® Crowns|Occlusal reduction by decreasing the occlusal surface to less than the natural occlusal profile by about 1-1.5 mm roughly. Proximal reduction by unfastening the interproximal contacts. The tooth should be trimmed down circumferentially by around 0.5-1.25 mm as needed. Subgingival reduction, leaving no undercuts or subgingival ridges, about 1-2 mm subgingivally on every area should be prepared. Completion of the preparation by eliminating sharp lines and pointed angles to allow all prepared areas to be marginally rounded and smoothed. ZR Zirconia Crwons NuSmile ® Crowns are fixed using Glass Ionomer cement (Fuji- Jaban).
15888366|NCT03740295|Dietary Supplement|Coconut oil and epigallocatechin gallate|600 mg of epigallocatechin gallate (EGCG) and 60 ml of coconut oil (3600 mg of TGCM) per day, divided into two doses (one in the morning and one at noon)
15888367|NCT03740295|Other|Placebo|Lactose
15888368|NCT03740282|Device|Lapiplasty|Patients 14 years through 58 years with symptomatic hallux valgus who are treated with the Lapiplasty System will begin weight-bearing by 3 weeks and follow a defined post-operative protocol.
15888369|NCT03740269|Other|oral health educational program|poster education about the important of oral health status, different brushing technique, different tooth paste, the balanced diet, changes occur to their mouth during the puberty period
15888370|NCT03740256|Biological|CAdVEC|The intratumoral administration of CAdVEC will create a pro-inflammatory tumor microenvironment and will promote the recruitment and expansion of adoptively transferred HER2 specific CAR T cells via CAR (tumor antigen). We expect HER2 CAR T cells expanded at primary tumor sites will re-circulate and target metastasized tumors. The combination we propose to test has the potential to overcome each of the established individual limitations of oncolytic viruses and of CAR T-cells. Testing each element separately would not be beneficial or informative, since the combination therapy is anticipated to have unique profiles of both therapeutic benefit and potential toxicities.
15888371|NCT03740243|Drug|Buprenorphine/naloxone|Buprenorphine/naloxone tablet or film
15888372|NCT03740243|Drug|Buprenorphine|Buprenorphine tablet
15888373|NCT03740217|Drug|GKT137831|oral bioavailable small molecule that selectively inhibit NOX1 and NOX4
15888374|NCT03740204|Drug|17-β estradiol transdermal patches with cyclic progesterone|17-β estradiol transdermal patches (100 mcg 17-β estradiol/day) with cyclic progesterone (200 mg micronized progesterone daily for 12 days every month)
15888375|NCT03740204|Drug|Placebo patch and pill|Placebo patch and pill
15888376|NCT03740191|Other|EPIC questionnaire|The EPIC questionnaire is used to evaluated the Quality of life of the patients including the sexual function.
15888377|NCT03740191|Radiation|kV x-ray images|After the applied daily fraction, x-ray imaging will be repeated daily to assess for intra-fraction motion of the prostate.
15888378|NCT03740191|Radiation|Conebeam CT|For the assessment of interfraction target and organs at risk movement. Conebeam CT as soon as it becomes available will be performed 5 x/week or at each day of proton therapy before treatment application.
15888379|NCT03740178|Drug|MK-4334|Participants with Alzheimer's clinical syndrome (MCI or mild/moderate AD) will receive MK-4334 capsules administered orally, QD on Days 1-14. Participants will receive an initial loading dose of 120 mg (Day 1), followed by a maintenance dose of 60 mg (Days 2-14). Open-label donepezil tablets (dose strength: 10 mg) administered orally, QD on Days 1-14.
15888380|NCT03740178|Drug|Placebo to MK-4334|Participants with Alzheimer's clinical syndrome (MCI or mild/moderate AD)will receive placebo capsules matching MK-4334 administered orally, QD on Days 1-14. Participants will also receive open-label donepezil tablets (dose strength: 10 mg) administered orally, QD on Days 1-14.
15888381|NCT03740178|Drug|Donepepzil|Participants with Alzheimer's clinical syndrome (MCI or mild/moderate AD) will receive open-label, oral donepezil 10 mg QD on Days 1-14.
15888382|NCT03740165|Biological|Pembrolizumab|IV infusion
15888383|NCT03740165|Drug|Placebo for pembrolizumab|IV infusion
15888392|NCT03740126|Diagnostic Test|Whole body 18F-FDG PET/CT|In the experimental arm (A), an FDG-PET/CT scan will replace the CT-scan at 6, 12, 18 and 24 months post-treatment. A standard CT-scan will be performed at 3, 9, 15 and 21 months post-treatment. All patients will be asked for a blood sample for liquid biopsy and to fill in a quality of life questionnaire, concurrently every 3 months.
15888393|NCT03740113|Behavioral|Kids SipSmartER|Kids SIPsmartER is grounded by the Theory of Planned Behavior as well as health literacy, media literacy, numeracy, and public health literacy concepts
15888394|NCT03740100|Drug|Bimiralisib|Bimiralisib capsules
15888395|NCT03740087|Other|Omnivorous diet|Determine if the transfer of bovine miRNAs is carried out after a meal containing beef.
15888396|NCT03740087|Other|Vegan diet|Used as a baseline for miRNA levels in blood
15888397|NCT03740074|Behavioral|PAI|"Consenting subjects will be given a Mio Slice, along with instructions on how to utilize the device.
~They will register on line with PAI Health, and will be asked to sync their device at least once every 7 days. They will be encouraged to look at the device app on their smart phone at least once daily.
~After 1 week of obtaining baseline data, subjects will be encouraged to try to obtain a PAI score of at least 30 initially. Once they obtain a score of 30 consistently, they will be encouraged to increase the score toward 50. If they consistently obtain 50, they can increase their goal sequentially toward a maximum goal of 100. The duration of the study will be 12 weeks."
15888398|NCT03740061|Diagnostic Test|Ultrasonographic assessment of muscle|Ultrasonographic assessment of quadriceps muscle
15888399|NCT03740048|Other|Hemodialysis|Hemodialysis frequency will differ in the first six weeks of hemodialysis therapy between the two treatment arms.
15888400|NCT03740048|Drug|Patiromer Oral Product|Participants in the intervention group who develop hyperkalemia, during the first six weeks of receiving hemodialysis twice per week, will be treated with Patiromer.
15888401|NCT03740035|Device|eHealth for Sedentary Behavior|Prostate cancer patients will be testing the usability and acceptability of the eHealth web app for sedentary behavior
15888402|NCT03740022|Procedure|ACL plasty|standard ligamentoplasty by Kenneth Jones
15888403|NCT03740022|Procedure|ACL + ALL plasty|standard ligamentoplasty and anterolateral plasty
15888404|NCT03740009|Drug|Bazedoxifene/Conjugated Estrogen|20 mg bazedoxifene/0.45mg conjugated estrogens tablets
15888405|NCT03739996|Drug|Oral Cabotegravir (CAB)|30 mg tablets administered orally
15888406|NCT03739996|Drug|Nucleoside Reverse Transcriptase Inhibitors (NRTIs)|NRTIs will not be provided by the study. Participants will obtain NRTIs outside of the study through routine care.
15888407|NCT03739996|Drug|Long-Acting Injectable Cabotegravir (CAB LA)|600 mg loading dose followed by 400 mg maintenance doses administered by intramuscular (IM) injection
15888408|NCT03739996|Biological|VRC07-523LS|40 mg/kg administered as an intravenous (IV) infusion
15888409|NCT03739996|Drug|Standard of Care (SOC) Oral ART|SOC ART will not be provided by the study. Participants will obtain SOC ART outside of the study through routine care.
15888411|NCT03739970|Dietary Supplement|Investigational Product (Silk Peptide)|"Ingredient: Silk Peptide
~Type: Yellow granule stick
~Storage: Room temperature
~Weight: Silk Peptide 9g/day
~Directions: with water before breakfast and dinner, 9g/day (4.5g×2times/day)
~Duration of use: 8 weeks"
15888412|NCT03739970|Dietary Supplement|Control Group - Placebo Product|"Ingredient: Microcrystalline Cellulose
~Type: Yellow granule stick
~Storage: Room temperature
~Weight: Silk Peptide 0g/day
~Directions: with water before breakfast and dinner, 9g/day (4.5g×2times/day)
~Duration of use: 8 weeks"
15888413|NCT03739957|Device|BPCO Media Kit|Telemonitoring system for patients with COPD
15888414|NCT03739944|Procedure|Laparotomic radical hysterectomy|Laparotomic radical hysterectomy for patients without fertility requirement
15888415|NCT03739944|Procedure|Laparotomic radical trachelectomy|Laparotomic radical hysterectomy for patients with fertility requirement
15888416|NCT03739944|Procedure|Laparoscopic radical hysterectomy|Laparoscopic radical hysterectomy for patients without fertility requirement
15888417|NCT03739944|Procedure|Laparoscopic radical trachelectomy|Laparoscopic radical hysterectomy for patients with fertility requirement
15888420|NCT03739905|Device|Blood Brain Barrier (BBB) Disruption|Focal Ultrasound (FUS) involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct targets to induce BBB disruption.
15888421|NCT03739892|Behavioral|standard stroke rehabilitation|standard rehabilitation according to the french standard care and to the severity of the patient
15888422|NCT03739879|Device|Inspiratory Muscle Trainer Philips Respironics|Subjects exercised using inspiratory muscle trainer (Philips Respironic®) for 8 weeks. Training dose with IMT was determined by inspiratory muscle strength result and adjusted in every evaluation visit. The subject was expected to do exercise twice daily for 15 minutes each session with 30-70% intensity from determined MIP score. Exercise is monitored and noted in a logbook.
15888423|NCT03739866|Drug|Lenacapavir|Administered subcutaneously in the abdomen
15888424|NCT03739866|Drug|Placebo|Administered subcutaneously in the abdomen
15888425|NCT03739866|Drug|B/F/TAF|50/200/25 mg tablets administered orally once daily
15888426|NCT03739866|Drug|TAF|Tablets administered orally
15888427|NCT03739853|Drug|Methotrexate|Used in all three arms of study
15888428|NCT03739853|Drug|Sulfasalazine|Used in arm 2 of study
15888429|NCT03739853|Drug|Leflunomide|Used in arm 2 of study
15888430|NCT03739853|Drug|Adalimumab|Used in arm 3 of the study only
15888433|NCT03739814|Biological|Blinatumomab|Given IV
15888434|NCT03739814|Biological|Inotuzumab Ozogamicin|Given IV
15888435|NCT03739801|Drug|Liposomal Irinotecan|Given IV
15888436|NCT03739801|Other|Quality-of-Life Assessment|Ancillary studies
15888437|NCT03739801|Other|Questionnaire Administration|Ancillary studies
15888438|NCT03739801|Biological|Ramucirumab|Given IV
15888439|NCT03739788|Drug|BMS-986165|Oral administration of tablet and 15-minute intravenous BMS-986165 solution for infusion
15888441|NCT03739762|Behavioral|i-STAND|Via in-person and phone coaching sessions, participants randomized to this arm will be coached to find ways to sit less and stand more, and look for ways to change their home environment to encourage this, as well as look at how their lifestyle may contribute to their sitting time. Participants in this arm may be re-randomized at the half-way point to continue with additional phone coaching sessions.
15888442|NCT03739762|Other|Healthy Living control|In this arm, participants will have phone coaching sessions focused on a variety of topics aimed at improving healthy habits. There is no focus on standing more or sitting less.
15888443|NCT03739749|Procedure|Arthroscopic superior capsular reconstruction|The superior capsule of patients with irreparable rotator cuff tears will be reconstructed using an autograft or an allograft
15888444|NCT03739736|Other|Combination of TB/HIV prevention activities (arm A)|The intervention consists in a package of combination TB/HIV prevention activities, including active case finding for TB and universal test and treat for HIV. In arm A ART was initiated regardless of CD4 count. The intervention was delivered over a period of four years (2014-2017) by community health workers within the The HPTN071(PopART) trial (NCT01900977)
15888445|NCT03739736|Other|Combination of TB/HIV prevention activities (arm B)|The intervention consists in a package of combination TB/HIV prevention activities, including active case finding for TB and universal test and treat for HIV. In this arm B ART was initiated according to national guidelines. The intervention was delivered over a period of four years (2014-2017) by community health workers within the The HPTN071(PopART) trial (NCT01900977)
15888446|NCT03739736|Other|Standard of care (arm C)|"The standard of care arm C communities have access to HIV testing services (usually at the health facility), HIV care and ART provision according to national guidelines. TB case finding is passive i.e. relies on individuals to present with symptoms to the health facility. TB diagnostics are as per national guidelines including Xpert®TB/RIF for those who are HIV positive. All diagnosed cases of TB are treated as in the intervention arm. TB screening and prevention at HIV care clinics are as is in the intervention arm."
15888447|NCT03739723|Other|Resource allocation to improve surgery training program culture|If a hospital/program is assigned to the intervention arm, they will receive numerous resources including a program-specific cultural outcomes report, a surgical culture toolkit, coaching calls, and in-person meetings to help improve their surgery training program culture.
15888448|NCT03739710|Drug|Docetaxel|Docetaxel will be administered as an intravenous (IV) infusion.
15888449|NCT03739710|Drug|GSK3359609 (feladilimab)|GSK3359609 will be administered as an IV infusion
15888450|NCT03739710|Drug|Ipilimumab|Ipilimumab will be administered as an IV infusion
15888451|NCT03739710|Drug|Niraparib|Niraparib will be administered orally
15888452|NCT03739710|Drug|Dostarlimab|Dostarlimab will be administered as an IV infusion
15888453|NCT03739710|Drug|Cobolimab|Cobolimab will be administered as an IV infusion
15888454|NCT03739697|Other|spontaneous breathing|spontaneous breathing during induction of anesthesia in infants
15888455|NCT03739684|Drug|18F-DCFPyL|A single dose of 9 mCi (333 MBq) IV injection of 18F-DCFPyL
15888456|NCT03739684|Diagnostic Test|PET/CT Imaging|PET/CT imaging will be acquired 1-2 hours post-PyL injection
15888457|NCT03739671|Dietary Supplement|Vitamin D|Group will receive 5000 units of vitamin D daily
15888458|NCT03739671|Dietary Supplement|No Vitamin D|No vitamin D supplementation
15888459|NCT03739658|Other|Education|Cognitive-Based Neuromuscular Training has the content of focusing on different tasks at the same time and coordinating on neuromuscular functions as well as football-specific movements. Game-Based Training (OTE), which includes football, tennis, bowling, shooting, racing and climbing games, consists of active video games of game consoles, which are frequently used among young people.
15888460|NCT03739645|Behavioral|conditioned fear|Subjects will be involved in a protocol producing fear conditioning protocol with colored lights as conditioned stimuli and laser pulses (duration 1'ms visual analog scale of pain 5/10) as the US and rating scales and questionnaires are administered. Networks will be defined parts of the brain which are activated (ERSP) and interact with each other as measured by event related causality (ERC).
15888461|NCT03739632|Drug|Hypidone Hydrochloride tablets|Hypidone Hydrochloride tablets will be given orally, twice daily, for 6 weeks
15888462|NCT03739632|Other|Placebo|Placebo tablets will be given orally, twice daily, for 6 weeks
15888463|NCT03739619|Drug|Bendamustine|Given IV
15888464|NCT03739619|Drug|Gemcitabine|Given IV
15888465|NCT03739619|Biological|Nivolumab|Given IV
15888466|NCT03739606|Biological|Anti-CD123/CD3 Monoclonal Antibody MGD006|Given IV
15888467|NCT03739593|Drug|AR-1105-CF1|AR-1105 clinical formulation 1 (AR-1105-CF1)
15888468|NCT03739593|Drug|AR-1105-CF2|AR-1105 clinical formulation 2 (AR-1105-CF2)
15888469|NCT03739580|Device|DCB angioplasty (Orchid, Acotec Scientific Co. Ltd.)|for popliteal stenosis/occlusive lesions, randomised received DCB or Stent deployment.
15888470|NCT03739580|Device|Stent (Maris,Medtronic.USA or Sinus/Supera, Germany)|for popliteal stenosis/occlusive lesions, randomised received DCB or Stent deployment.
15888471|NCT03739554|Drug|CYC065|intravenous infusion
15888472|NCT03739554|Drug|Venetoclax|oral capsule
15888473|NCT03739541|Drug|[14C]-Benznidazole|A single dose level of 100 mg; 200 μCi (7.4 MBq)
15888474|NCT03739528|Drug|Levofloxacin + dexamethasone followed by dexamethasone|Levofloxacin + dexamethasone ophthalmic solution for 7 days, 1 drop - 4 times a day, followed by dexamethasone ophthalmic suspension (Maxidex®) for an additional 7 days, 1 drop - 4 times a day.
15888475|NCT03739528|Drug|Tobramycin + Dexamethasone|Tobramycin + dexamethasone ophthalmic suspension (Tobradex®) for 14 days, 1 drop - 4 times a day.
15888476|NCT03739515|Other|HSCP intervention|A team of HSCPs (physiotherapist, occupational therapist, medical social worker) will provide comprehensive functional assessment to older patients
15888477|NCT03739515|Other|ED routine care|ED staff including consultants and nurses will provide patients with routine ED medical care.
15888498|NCT03739372|Other|Specialized tumor board recommendation|Based on the molecular profile, the specialized tumor board will determine an individualized treatment recommendation for each patient using up to four FDA approved drugs. In special circumstances, Investigational new drug (IND) study agents may be used.
15888478|NCT03739502|Drug|Hyperbaric oxygen|"The UCB transplant is a type of stem cell transplant used to treat cancer of the blood or lymph glands. The UCB transplant has advantages over other types of transplants such as ease of obtaining the umbilical cord blood, absence of donor risks, reduced risks of contagious infections, and the availability for immediate use. The UCB transplant is also associated with a lower incidence of graft versus host disease, or GvHD (in GvHD, the transplanted graft attacks the recipient organs).
~However, UCB as a graft source for a bone marrow transplant has drawbacks related to the limited cell dose available for transplant and defects in homing. Homing is the process of UCB stem cell lodging in the bone marrow. If the homing is not efficient it could delay the re-population of the stem cells (or engraftment), possibly lead to engraftment failure, and delay the rebuilding of the immune system after transplant. This could, in turn, provide a higher risk to infection after the UCB transplant."
15888479|NCT03739489|Procedure|Repetitive transcranial magnetic stimulation|Repetitive transcranial magnetic stimulation was a technique able to modulate the brain circuit restoring the function.
15888480|NCT03739476|Drug|Quetiapine 25 milligrams capsule|Compare the incidence of postoperative delirium.
15888481|NCT03739476|Drug|Placebo oral capsule|Compare the incidence of postoperative delirium.
15888482|NCT03739463|Dietary Supplement|MAG-DHA|375 MG of MAG-DHA per capsules, two capsules BID
15888483|NCT03739463|Dietary Supplement|Oleic acid|375 MG of sunflower oil (oleic acid) per capsules, two capsules BID
15888484|NCT03739450|Behavioral|Problem Solving Training (PST)|The PST intervention consists of six sessions that will follow a structured format based on the PST manual. In these sessions, the interventionist will first provide the TBI-specific education, introduce the participant to the PST steps, then help the care partner generate and select a problem to address first. Interventionist will facilitate the care partner's use of the ABCDEF steps of PST to develop a specific action plan to solve the problem. As problems are attempted or solved, the care partner will learn how to perform the steps on his/her own, thus acquiring self-management problem solving skills that will be applicable to future problems. The final session will include a review and generalization of the PST steps and progress made.
15888485|NCT03739450|Behavioral|Education|Participants will receive TBI-specific education alone through a workbook. It consists of educational modules for self-study, common sequelae of TBI, issues encountered by care partners, work and school concerns for those with TBI, and on navigating the rehab system and accessing resources. The modules consist of a brief introduction, key definitions, examples, resources, and a summary. Some chapters also include self-directed activities, such as worksheets or checklists. The investigators will provide a brief orientation to the workbook and include open-ended questions about the participants' need for clarification or questions of the education material. The last session will consist of an open discussion about expected problems that may arise post-discharge.
15888486|NCT03739437|Behavioral|Mobile Contingency Management|Participants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and a smartphone app that remotely verifies participant identity and smoking abstinence and automatically credits a gift card account for evidence of smoking abstinence.
15888487|NCT03739437|Behavioral|Standard Care|Participants will be offered six tobacco cessation telephone counseling sessions, 12 weeks of nicotine replacement therapy, and incentives that are not contingent on smoking abstinence (incentives are yoked to participants in the contingency management group).
15888488|NCT03739424|Other|Whole egg powder|Participants will receive waffles, pancakes, brownies, ice cream and mac and cheese made with whole egg powder. The food projects were developed specifically for this study by the University of Georgia's Food Product Innovation and Commercialization Center and consumer tested by children within the study age range prior to intervention enrollment.
15888489|NCT03739424|Other|Whole milk powder|Participants will receive waffles, pancakes, brownies, ice cream and mac and cheese made with whole milk powder. The food projects were developed specifically for this study by the University of Georgia's Food Product Innovation and Commercialization Center and consumer tested by children within the study age range prior to intervention enrollment.
15888490|NCT03739424|Other|Gelatin food product|Participants will receive waffles, pancakes, brownies, ice cream and mac and cheese made with gelatin. The food projects were developed specifically for this study by the University of Georgia's Food Product Innovation and Commercialization Center and consumer tested by children within the study age range prior to intervention enrollment.
15888491|NCT03739411|Radiation|Hyperpolarized Carbon C 13 Pyruvate|Given IV
15888492|NCT03739411|Procedure|Magnetic Resonance Imaging|Undergo MRI
15888493|NCT03739411|Radiation|Radiation Therapy|Undergo radiation therapy
15888494|NCT03739411|Drug|Temozolomide|
15888495|NCT03739398|Device|LUTRONIC GENUS laser(Fractional Microneedle Radiofrequency(FMR))|1. LUTRONIC GENUS laser(Fractional Microneedle Radiofrequency(FMR)) : Fractional Microneedle Radiofrequency (FMR) equipment is a device that penetrates the epidermis and irradiates the high frequency by entering the dermis. The generated radiofrequency transfers heat energy and induces thermal denaturation in the surrounding tissue. Using this principle, FMR equipment is being used as a very effective treatment for scarring, enlarged pores, hyperhidrosis as well as wrinkles. Unlike conventional treatments, FMR equipment has the advantage of a short recovery time after treatment because it minimizes damage to the epidermis because the insulated microspheres penetrate the skin and generate high frequency only at the end of the microspheres.
15888496|NCT03739398|Device|LASEMED laser(The Thulium laser with 1,927nm wavelength)|"2. LASEMD laser(The Thulium laser with 1,927nm wavelength) The Thulium laser with 1,927nm wavelength is a device that effectively removes various skin diseases present in the epidermis while minimizing the side effects such as scarring and pigmentation because it induces thermal damage to the only skin surface compared to conventional laser equipment. In recent years, not only skin lesions on the epidermis but also pigment disease and wrinkles have been reported to have a good effect.
~In this study, we investigated the effect and stability of combined treatment of Thulium laser with 1,927nm wavelength in addition to FMR equipment which has already proven to be effective in improving skin aging."
15888497|NCT03739385|Other|Exercise Intervention|The training interventions of all three groups (intergenerational group, peer group seniors, peer group children) will occur under professional supervision twice a week lasting over a 25-week period with training sessions lasting 45 minutes each. Control groups (control group seniors, control group children) receive no intervention.
15888530|NCT03739060|Device|Transcutaneous electric nerve stimulation|Conventional transcutaneous electric nerve stimulation
15888499|NCT03739359|Other|nasal cannula gas flow|High flow nasal cannula (HFNC) is a relatively new oxygen device, which provides warmed and humidified oxygen for patients. When patients need to inhale aerosolized medication during HFNC, the nebulizer will be placed in-line in order to provide both treatments. This study will investigate the influence of three flow settings (50 L/min, GF:IF=1, GF:IF=0.5) on the clinical effects of nebulization.
15888500|NCT03739346|Behavioral|Hypnosis|Therapeutic technique in which clinicians make suggestions to individuals who have undergone a procedure designed to relax them and focus their minds.
15888501|NCT03739346|Behavioral|Tell, show, do technique|The technique involves verbal explanations of procedures in phrases appropriate to the developmental level of the patient (tell); demonstrations for the patient of the visual, auditory, olfactory, and tactile aspects of the procedure in a carefully defined, nonthreatening setting (show); and then, without deviating from the explanation and demonstration, completion of the procedure (do). Tell-show-do technique is used with communication skills (verbal and nonverbal) and positive reinforcement.
15888502|NCT03739333|Other|11C-Methionine PET-MRI|Implementation 11C-Methionine PET-MRI performed for each patient in one place (department of nuclear medicine of Hospices Civils de Lyon). The 11C-Methionine PET-MRI will be performed after radiochemotherapy in patients with MRI suspicious of pseudoprogression.
15888503|NCT03739320|Drug|Mepolizumab 100 MG Injection [Nucala]|100 milligrams subcutaneously once every 4 weeks
15888504|NCT03739294|Drug|Fluticasone Furoate/ Vilanterol Trifenatate|Asthma inhalation medication
15888505|NCT03739281|Diagnostic Test|PET/MR|The included patients are imaged with PET/MR as part of the research protocol.
15888506|NCT03739281|Diagnostic Test|PET/CT|The included patients are imaged with PET/CT as part of normal clinical routine.
15888507|NCT03739268|Drug|Sevelamer|Sevelamer powder dissolved in water 1,600 mg three times a day for 17 days
15888508|NCT03739268|Drug|Placebo|placebo powder dissolved in water 1,600 mg three times a day for 17 days
15888509|NCT03739255|Device|Cacicol20|Cacicol20 is supplied as a sterile single-dose solution of alpha 1-6 poly-carboxymethyl glucose sulfate One drop is instilled at each application to impregnate cornea.
15888510|NCT03739255|Device|Placebo|Ocluac is artificial tear which contains Hydroxypropylmethyl Cellulose and Sodium Chloride, It is presented in a 0.4 mL vial. One drop is delivered at each application.
15888511|NCT03739242|Dietary Supplement|Nutraceutical combination|One tablet per os per day to be taken in the evening from randomization (day 0) to the end of the trial (day 56 +/- 3)
15888512|NCT03739242|Other|Placebo|One tablet per os per day to be taken in the evening from randomization (day 0) to the end of the trial (day 56 +/- 3)
15888513|NCT03739229|Biological|Placebo|2 intranasal administrations of lyophilized purified allantoic fluid of chicken embryos with stabilizers
15888514|NCT03739229|Biological|H7N9 LAIV|2 intranasal administrations of H7N9 live influenza vaccine
15888515|NCT03739216|Device|ClariFix|The ClariFix device is a handheld cryosurgical device which provides focal, controlled freezing to the target tissue.
15888516|NCT03739203|Drug|Cariprazine|Cariprazine supplied in capsules
15888517|NCT03739203|Drug|Placebo|Placebo supplied in capsules
15888518|NCT03739190|Device|NRL Condom|A minimum of 5 condoms (maximum 7 condoms) of each condom type will be provided to Subjects to be used during vaginal intercourse over a 4 week period, the assessment period. Couples will repeat the assessment period each of the 3 condom types.
15888519|NCT03739177|Diagnostic Test|Onco4D Biodynamic Chemotherapy Selection Assay|The Onco4D Biodynamic Chemotherapy Selection Assay uses Motility Contrast Tomography (MCT) to measure ex-vivo fresh tumor biopsy response when challenged by an array of chemotherapeutic agents. A machine learning algorithm uses the MCT datastream to predict in vivo tumor response or non response to chemotherapy.
15888520|NCT03739151|Behavioral|Behavioral Obesity Treatment|"Self-monitoring. Participants will be taught to record their weight, the calories of each food item, and physical activity using a method of their choice (e.g., commercial smartphone app, paper diary). The clinician will review dietary intake and provide personalized feedback at the outset of session.
~Diet. Per national guidelines for weight loss, a daily goal of 1200-1800 kcal/day will be prescribed depending on baseline weight. A Mediterranean diet will be prescribed to meet the recommended calorie goal and be consistent with dietary recommendations for CVD patients.
~Exercise. Participants will be encouraged to achieve 250 minutes/week of moderate intensity activity in accordance with current national recommendations for physical activity among individuals attempting weight loss. Participants will be encouraged to gradually increase activity level to achieve approximately 50 minutes of activity over five days per week."
15888521|NCT03739138|Biological|MK-4621/JetPEI™|"For Arm 1: administered intratumorally Q1W, on Days 1, 8, and 15 of each 21-day cycle.
~For Arm 2: administered intratumorally Q1W, on Days 1, 8, and 15 of each 21-day cycle. Range administered will depend upon allocation and be based on emerging safety data.
~For Arm 3: administered intratumorally Q3W, on Day 1 of each 21-day cycle. Range administered will depend upon allocation and be based on emerging safety data."
15888522|NCT03739138|Biological|Pembrolizumab|200 mg administered intravenously (IV) on Day 1 of each 21-day cycle beginning with Cycle 1 (Arm 2) or Cycle 2 (Arm 3).
15888523|NCT03739125|Drug|CKD-501 0.5mg|CKD-501 0.5mg, orally, 1 tablet once a day for 24weeks or 52weeks(if extension study) with D150 and D745
15888524|NCT03739125|Drug|Placebo|orally, 1 tablet once a day for 24weeks or 52weeks(if extension study) with D150 and D745
15888525|NCT03739112|Biological|Quadrivalent VLP Vaccine|Single dose of a 30 µg/strain of Quadrivalent VLP Vaccine
15888526|NCT03739112|Biological|Quadrivalent Comparator Vaccine|Single dose of a 15 ug/strain of Quadrivalent Comparator Vaccine
15888528|NCT03739086|Procedure|erector spinae plane block|unilateral or bilateral or bilevel erector spinae plane block performance for postoperative pain or acute pain
15888529|NCT03739073|Other|OCTA (angiography by tomography in optical coherence)|The study concerns patients with intermediate stenosis of the left anterior descending artery (LDA). A fundus oculi and an OCTA (angiography by tomography in optical coherence) examination will be performed; it's a non-invasive imaging test. OCT uses light waves to take cross-section pictures of your retina and then ophthalmological examination data will correlate with coronary angiography.
15888531|NCT03739047|Behavioral|Desensitization with flipped spoon|Both groups will begin with a baseline phase: escape extinction (non-removal of an upright small maroon spoon) plus continuous access to reinforcement. The baseline phase will take place for 3, 5-bite sessions or until the data become stable. The baseline phase will be followed by desensitization. Desensitization will be conducted for 3, 45-minute treatment meals. Puree will be presented on a flipped EZ spoon after the desensitization sessions are completed. Bite size will be gradually increased. Acceptance of an upright EZ spoon and eventually an upright maroon spoon will be probed based on stability of the data.
15888532|NCT03739047|Behavioral|flipped spoon|Both groups will begin with a baseline phase: escape extinction (non-removal of an upright small maroon spoon) plus continuous access to reinforcement. The baseline phase will take place for 3, 5-bite sessions or until the data become stable. The baseline phase will be followed by puree being presented from a flipped EZ spoon. Bite size will be gradually increased. Acceptance of an upright EZ spoon and eventually an upright maroon spoon will be probed based on stability of the data.
15888533|NCT03739034|Behavioral|Lifestyle Medicine|Treatment modalities consist of encouraging a plant based, whole food diet, physical activity, stress management, healthy sleep, control of unhealthy habits.
15888534|NCT03739021|Drug|Exparel|Single shot of the Bupivacaine Liposome, and then we follow up with patient in the recovery room with traditional common pain management. MME (milligram morphine equivalent) will be collected.
15888535|NCT03739021|Drug|Ropivacaine|Continuous infusion of Ropivacaine via catheter, and then we follow up with patient in the recovery room with traditional common pain management. MME (milligram morphine equivalent) will be collected.
15888536|NCT03738995|Biological|Red cell or whole blood transfusion during pregnancy and up to 6 weeks postpartum|Administration of red cell or whole blood transfusion to parturients during pregnancy and up to 6 weeks postpartum
15888537|NCT03738982|Device|PEPPER|In the phase 1 participants will use PEPPER safety system (with the CBR algorithm enabled) and in the phase 2 participants will use whole PEPPER system (with the CBR algorithm integrated).
15888538|NCT03738969|Procedure|Laparotomic radical hysterectomy|Radical hysterectomy applied by laparotomy
15888539|NCT03738969|Procedure|Laparoscopic radical hysterectomy|Radical hysterectomy applied by laparoscopic
15888540|NCT03738956|Drug|Tofacitinib|"The study subjects fulfilling the inclusion criteria will receive tofacitinib 5mg BD.
~All the patients in the study group will go through disease history, clinical examination and baseline investigations. Baseline charachteristics and variables will be recorded at initiation of therapy, 4th, 12th and 24th week. Primary endpoint of efficacy will be assessed using ASAS 20 response at the end of 12 th wk. At the end of 12 th week, those patients will achieve primary endpoint will continue with the same dose and those patients who will not achieve primary endpoint will be put on tofacitinib10 mg BD. Those patients who will not respond to treatment at the end of 24 th wk will discontinue the therapy and put on alternative treatment."
15888541|NCT03738943|Drug|Adenosine Triphosphate|See arm/group descriptions
15888542|NCT03738943|Drug|Acetylcholine|See arm/group descriptions
15888543|NCT03738943|Drug|Sodium Nitroprusside|See arm/group descriptions
15888544|NCT03738943|Drug|Adenosine Diphosphate|See arm/group descriptions
15888545|NCT03738943|Drug|Adenosine Monophosphate|See arm/group descriptions
15888546|NCT03738943|Drug|Uridine Triphosphate|See arm/group descriptions
15888547|NCT03738943|Drug|Adenosine|See arm/group descriptions
15888548|NCT03738943|Drug|Vitamin B 6|See arm/group descriptions
15888549|NCT03738943|Drug|Pyridoxal 5'-Phosphate|See arm/group descriptions
15888550|NCT03738930|Behavioral|AI based mHealth system|AI based mHealth system is used to deliver self-management contral message and health education message to make patients take notice of bleeding events after PCI.
15888551|NCT03738917|Drug|Dextromethorphan 15 milligrams|This drug is already marketed, and therefore, the manufacturer is responsible for the elaboration and control of samples. This study drug will be provided free to the participants by the sponsor.
15888552|NCT03738917|Drug|Ipratropium Bromide 20Micrograms Inhaler|This drug is already marketed, and therefore, the manufacturer is responsible for the elaboration and control of samples. This study drug will be provided free to the participants by the sponsor.
15888553|NCT03738917|Dietary Supplement|Honey 30 g (full tablespoon)|This study product will be provided free to the participants by the sponsor.
15888554|NCT03738917|Other|Usual clinical practice|Clinicians will not be allowed to prescribe antitussives, including codeine, anticholinergic inhalers and they will not be allowed to recommend the use of honey.
15888557|NCT03738891|Device|The ZELTIQ System|The CoolSculpting machine will be used to perform the treatments.
15888558|NCT03738878|Drug|Valsartan|oral valsartan
15888559|NCT03738878|Drug|LCZ696|oral LCZ696
15888560|NCT03738878|Drug|Bradykinin|Intra-arterial bradykinin at three graded doses
15888561|NCT03738878|Drug|Substance P|Intra-arterial substance P at three graded doses
15888562|NCT03738878|Drug|BNP|Intra-arterial BNP at three graded doses
15888563|NCT03738878|Drug|Sitagliptin|oral sitagliptin
15888564|NCT03738865|Drug|G-Pen|1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector
15888565|NCT03738865|Drug|Novo Glucagon|1 mg subcutaneous injection of Novo Glucagon (glucagon injection)
15888566|NCT03738852|Device|Continuous Glucose Monitor (CGM)|Continuous Glucose Monitor (CGM)
15888567|NCT03738852|Drug|Insulin|standard insulin regimen
15888568|NCT03738839|Device|Quantitative Light-Induced Fluorescence|White spot lesion on the tooth surfaces detected with Quantitative Light-Induced Fluorescence Orthodontic Bonding.
15888569|NCT03738839|Procedure|Direct bonding|The patients in the direct bonding group received a bonding procedure with a conventional composite adhesive.
15888570|NCT03738839|Procedure|Indirect bonding|For the patients in the indirect bonding group, bonding was performed with a flowable composite adhesive.
15888571|NCT03738826|Behavioral|Behavioral Intervention|Lupus clinic providers will be prompted to assess adherence level using Surescripts refill information and address any adherence barriers that arise during the clinical encounter.
15888574|NCT03738800|Drug|CD5789 Cream 200 µg/g|A fixed dose (determined at Visit 1) of 200 µg/g applied topically twice weekly to up to 90% BSA
15888575|NCT03738800|Drug|CD5789 Cream 100 µg/g|A fixed dose (determined at Visit 1) of 100 µg/g applied topically twice weekly to up to 90% BSA
15888576|NCT03738800|Drug|CD5789 Cream Vehicle|A fixed dose (determined at Visit 1) applied topically twice weekly, up to 36 g per dose up to 90% BSA
15888577|NCT03738787|Procedure|Pancreatic duct occlusion with Neoprene|Pancreatic duct occlusion of the pancreatic stump with Neoprene-based glue after Pancreatoduodenectomy.
15888578|NCT03738787|Procedure|Pancreato-Jejunal anastomosis|Standardized pancreato-jejunal anastomosis after Pancreatoduodenectomy
15888579|NCT03738761|Drug|Amlessa®|Fixed-dose combination (FDC) of perindopril/amlodipine, tablets. Strengths: 4mg/5 mg, 8mg/5 mg, 8mg/10 mg.
15888580|NCT03738761|Drug|Co-Amlessa®|Fixed-dose combination (FDC) of perindopril/indapamide/amlodipine, tablets. Strengths: 4mg/1.25 mg/5 mg, 8mg/2.5 mg/5 mg, 8mg/2.5 mg/10 mg.
15888581|NCT03738748|Other|Ultrasound- guided Percutaneous Neuromulation|The experimental group will be treated with percutaneous neuromodulation using a needle with Physio Invasive® device, in its modality of percutaneous electrostimulation for 15 minutes, and guided by ultrasound equipment in the multifidus muscles of L-3, once a week for 4 weeks.
15888582|NCT03738748|Other|TENS Therapy|The control group will apply a transcutaneous treatment with surface electrodes with TENS current at 170 Hz for 15 minutes in the L-3 region, once a week for 4 weeks.
15888583|NCT03738735|Drug|Hypertonic saline|For the intervention group, the surgical staff will add 120 mL of 23.4% saline to the 3L bags of lactated Ringer's solution, and this new solution will be used for arthroscopic irrigation purposes throughout the rotator cuff repair surgery.
15888584|NCT03738722|Drug|Oxygen|HFNCT (high flow nasal cannula therapy) will be provided using OptiFlow by Fisher&Paykel.
15888585|NCT03738709|Behavioral|Falls prevention and education giving a demonstration of the usage of technical assistance.|"Ecological trail to work on balance and walking.
~Technical assistance presentation and try-outs within the therapeutic apartment.
~Discussion on the perceived feelings over the exercises and the technical assistance submitted.
~Falls Education and prevention, screening of the dangerous activities and education on the safe behaviours."
15888586|NCT03738696|Drug|Exparel|A long-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
15888587|NCT03738696|Drug|Ropivacaine|A short-acting injectable sodium channel blocker bound to lipid that is indicated in controlling postoperative pain
15888588|NCT03738683|Drug|Piperacillin/tazobactam|Dose according to summary of product characteristics (SPC) or local protocols
15888589|NCT03738670|Procedure|Percutaneous RFA|Single session percutaneous extra-spinal bone metastasis destruction to achieve pain relief
15888590|NCT03738657|Other|Olfactory screening|Therefore prior to gustatory testing, patients will be screened and assessed as having either normal or abnormal olfactory function using the Sniffin' Sticks (Burghart; Wedel, Germany). The test consists of 12 odour pens which represent every-day odours (peppermint, fish, coffee, banana, orange, rose, lemon, pineapple, cinnamon, cloves, leather and liquorice). Patients are presented with an odour and select the perceived smell using a multiple-forced-choice method.
15888591|NCT03738657|Other|Quantative Gustatory Testing using Taste Strips|"Following screening for olfactory function, whole mouth gustatory function will be assessed using validated taste strips (Burghart; Wedel, Germany). Filter paper test strips are impregnated at one end with 2cm2 of either sweet, sour, salty or bitter taste solutions in four concentrations. In a pseudo-randomised sequence, individual strips will be placed on the tongue and patients will be asked to close their mouth in order to assess whole mouth function. Through a forced-choice procedure patients will be asked to identify the taste stimuli. Scores for individual taste qualities will range from 0-4 and an overall taste score will range from 0-16.
~Patients will rinse their mouth with tap water prior the application of each taste strip."
15888592|NCT03738644|Other|Monitoring with near-infrared spectroscopy|"No interventions are used. Stroke patients are examined with near-infrared spectroscopy (NIRS). NIRS examinations are done with Octamon system (Artinis Medical Systems, Elst, The Netherlands) consisting of 8 transmitters emitting infrared light of 760 and 850 nm and 2 receivers measuring oxygenated and deoxygenated hemoglobin in the frontal cortex.
~Examination protocol can be found in detailed description."
15888593|NCT03738618|Drug|Follitropin delta|Follitropin delta
15888594|NCT03738618|Drug|Placebo|Placebo
15888595|NCT03738605|Device|Microablative Fractional CO2 Laser Therapy|5 laser therapies intravaginally administered will be applied at monthly intervals.
15888596|NCT03738592|Other|behavioral exploration of spatial hearing performances|"Normal hearing children and cochlear implant children will have to localize a sound source in three dimensional space by using a virtual reality system (Neuro immersion platform). The experiment will last thirty minutes.
~For normal hearing children, this experience will be performed at the inclusion visit.
~For cochlear implant children, this experience will be performed 28 days (+/- 2 days) after inclusion."
15888597|NCT03738592|Other|The Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire (for cochlear implant children and their parents)|"For cochlear implant children and their parents, a SSQ questionnaire will be given and completed during the first visit (at the inclusion).
~This questionnaire offers a version for parents of children with hearing loss (SSQ Parents CI) and a version for the children themselves (SSQ Children CI)."
15888598|NCT03738592|Other|The Speech, Spatial and Qualities of Hearing Scale (SSQ) questionnaire (for parents of CI children)|"The SSQ questionnaire for Parents of CI children is composed of three distinct sections (A, B and C).
~Each section will be filled separately by parents of CI children with one of the study collaborators during 3 telephone calls spaced 1 week apart. Thus, section A will be completed 7 days (+/- 2 days) after inclusion , section B 14 days (+/- 2 days) after inclusion, and section C 21 days (+/- 2 days) after inclusion."
15888599|NCT03738579|Device|Next Science Group|TorrentX Wound Wash will be used for irrigation and then BlastX Wound Gel will be applied to the wound after debridement/irrigation during in-clinic visits. BlastX Wound Gel will be re-applied again during mid-week dressing change. Dressing used will be plain foam dressing from control group arm.
15888600|NCT03738579|Device|Control Group|Foam Dressing will be used in conjunction with standard of care for chronic wound management, such as debridement and irrigation.
15888601|NCT03738579|Device|Antibacterial Control Group|Foam Dressing AG will be used in conjunction with standard of care for chronic wound management, such as debridement and irrigation.
15888602|NCT03738566|Device|Esophageal self dilation|Esophageal self dilation therapy (ESDT), where the patient learns to pass a polyvinyl dilator orally on a routine basis teaching will take over 1-3 training sessions by one of two esophageal physicians and a nurse. Patients will be instructed to start Esophageal self dilation twice a day. If dysphagia is adequately controlled, and there was no resistance with passing the dilator, patients will be asked to decrease the frequency of ESDT to daily, weekly, and monthly over an average period of 6 months as directed by the esophageal care team.
15888603|NCT03738566|Procedure|Upper Endoscopy with Dilation|Patients will undergo repeat endoscopy and dilation as needed if their dysphagia relapse which is the current standard of care.
15888604|NCT03738553|Device|MRI|Diffusion Weighted Imaging and Dynamic Contrast enhanced MRI
15888605|NCT03738553|Drug|Trastuzumab|Single dose of Trastuzumab prior to surgery
15888606|NCT03738540|Behavioral|TALK study group|Telephone Delivered Intervention
15888607|NCT03738540|Behavioral|TALK control group|Telephone Delivered Intervention
15888608|NCT03738527|Drug|Tranexamic Acid 100mg/mL, 20mL topical|"Drug: Tranexamic Acid
~20 mL TXA (100 mg/mL injection solution, total 2g TXA) applied topically to the mastectomy cavity for 5 minutes before wound closure"
15888609|NCT03738527|Drug|Normal Saline Flush, 0.9%, 20mL topical|"Drug: Normal Saline
~20 mL 0.9% NaCl (normal saline) applied topically to the mastectomy cavity for 5 minutes before wound closure"
15888610|NCT03738514|Other|5% fluorocalcium phosphosilicate dentifrice|dentifrice containing 5% fluorocalcium phosphosilicate and VAS score assessed at Baseline, 2 weeks, 6 weeks
15888611|NCT03738514|Other|5% potassium nitrate dentifrice|5% potassium nitrate dentifrice and VAS score assessed at Baseline, 2weeks, 6 weeks.
15888612|NCT03738514|Other|Placebo dentrifice|placebo dentifrice and VAS score assessed at Baseline, 2weeks, 6 weeks
15888613|NCT03738501|Other|Chest physiotherapy with SET|Chest physiotherapy with SET, and standard treatment (medical treatment, health education, nasopharyngeal clearance, advice)
15888614|NCT03738501|Other|Standard Treatment|Standard pharmacological and non-pharmacological treatments (medical treatment, health education, rhinopharyngeal clearance, advices)
15888615|NCT03738488|Device|3D printing + images|To perform a surgery planification with the combination of the images available and the 3D biomodel in terms of: anticipation of potential complications and the human resources and necessary materials
15888616|NCT03738488|Other|Images|To perform a surgery planification with the images available in terms of: anticipation of potential complications and the human resources and necessary materials
15888617|NCT03738475|Drug|TIMP-GLIA|8 mg/kg up to a maximum of 650 mg administered intravenously on days 1 and 8.
15888618|NCT03738475|Drug|Placebo|Administered intravenously on days 1 and 8.
15888619|NCT03738462|Device|Conformis Hip System|The Conformis Hip System is an FDA cleared, uncemented, primary total hip replacement device composed of femoral and acetabular components. The system incorporates the use of a pre-operative CT scan to design patient-specific implants and instruments. Using patient imaging (CT scan), a patient-specific implant is designed that best meets the geometric and anatomic requirements of the specific patient. In addition, each Conformis Hip System device is shipped with an additional (optional) femoral stem (Cordera Femoral Stem).
15888620|NCT03738449|Drug|CKD-387|Test drug
15888621|NCT03738449|Drug|D484|reference drug
15888622|NCT03738436|Other|Physical therapy traditional neuromuscular training, NMT|The NMT program includes re-position exercise using Swiss ball roll squat, strengthening and stretching exercises in various positions or combined using Swiss ball, Thera-Band or suspension system (Redcord), balance exercise on wobble board, proper landing strategy practices, and etc.
15888623|NCT03738436|Other|Physical therapy modified visual feedback, MVF|traditional neuromuscular training (as in NMT group), but with modified visual feedback by eyes closed, reduced lighting or wearing strobe goggles
15888624|NCT03738423|Drug|REGN3500|Administered subcutaneous (SC)
15888625|NCT03738423|Drug|REGN3500-Matching Placebo|Administered subcutaneous (SC)
15888626|NCT03738410|Behavioral|Mobile Health Messaging application|Mobile messaging sent to participants over a 12-month period.
15888627|NCT03738410|Other|Standard of Care Treatment|Standard of care (SOC) is defined as the usual care a licensed health care provider would give patients to treat HIV/AIDS. SOC associated procedures and policies may vary across clinical settings.
15888628|NCT03738397|Drug|Upadacitinib (ABT-494)|Oral; Tablet
15888629|NCT03738397|Drug|Dupilumab|Dupilumab is administered as a subcutaneous (SC) injection
15888630|NCT03738397|Drug|Placebo|Placebo pre-filled syringe is as administered subcutaneous (SC) injections
15888631|NCT03738397|Drug|Placebo|Oral; Tablet
15888632|NCT03738384|Device|Knee Connect + Visual Feedback System|A device to measure knee angle. It sends data a smartphone or tablet to be displayed as part of a visual feedback system.
15888633|NCT03738371|Other|In situ simulation|Team involved in thrombectomy procedures will be trained by in situ simulation. Simulation will reproduce the initial step of a thrombectomy procedure, i.e from from the installation of the patient to the percutaneous punch by the neuroradiologist. Simulation will be followed by a debriefing focused on the team performance. Three in situ simulation sessions will be realized by each team.
15888634|NCT03738358|Dietary Supplement|Trehalose|80 mL pouch/day for 12 weeks, containing trehalose 5 g, water 74.92 g and scent additive 0.08 g
15888635|NCT03738358|Other|Placebo|80 mL pouch/day for 12 weeks, containing water 79.92 g and scent additive 0.08 g
15888636|NCT03738345|Other|HFNC flow|HFNC flow will be titrated based on the hospital's policy or protocol for hypoxemic patients and research protocol for healthy volunteers
15888637|NCT03738332|Device|Low-Level Laser|Low-level laser therapy
15888638|NCT03738319|Genetic|Sequencing of miRNA/lncRNA|Next generation sequencing of micro-RNA (miRNA) and long non-coding RNA (lncRNA)
15888639|NCT03738306|Other|Mezieres Method|"The Mézières treatment have 3 postures that could be adapted to each patient, depending on his/her needs to correct variations in the dorsal curve and promote diaphragmatic breathing. The first objective was to recover extensibility of the hypertonic muscle groups and, in particular, those in the low back muscular chain: the paravertebral muscles and latissimus dorsi."
15888640|NCT03738306|Other|Conventional Physiotherapy|therapeutic exercise; physical agents
15888641|NCT03738280|Diagnostic Test|Endoscopic ultrasound-fine needle biopsy|Patients with non-hypovascular solid pancreatic lesion undergo endoscopic ultrasound-fine needle biopsy
15888642|NCT03738254|Other|The Guardians: A smartphone game|"The Guardians is a mix of two popular game genres: idle games (a game that doesn't require constant player input in order to progress in the game, but often progresses exponentially in response to a few user inputs, e.g., Cookie Clicker and Adventure Capitalist) and pet collection games (a game where the player seeks to collect all of the pets in a set, e.g., Pokemon or Neko Atsume). The game gives the player an in-game reward for completing a survey."
15888643|NCT03738254|Other|Paper Survey|Paper version of daily survey
15888644|NCT03738254|Other|Electronic Survey|Electronic version of daily survey administered via a smartphone app.
15888645|NCT03738241|Biological|A/H7N9|Monovalent split 2017 A/H7N9 Inactivated Influenza Virus Vaccine containing the Hemagglutinin (HA) and Neuraminidase (NA) from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and the PB2, PB1, PA, NP, M and NS from A/Puerto Rico/8/1934 (H1N1). The HA content of the 2017 A/H7N9 vaccine formulations were determined by Single Radial Immunodiffusion (SRID) assay to be approximately two times higher (14.45 mcg of HA per 0.5 mL dose) than the targeted HA content on the label (7.5 mcg of HA per 0.5 mL dose).
15888646|NCT03738241|Drug|AS03|AS03 oil-in-water emulsion-based adjuvant system containing DL-alpha-tocopherol, squalene, polysorbate 80, and a buffer.
15888647|NCT03738241|Other|Phosphate Buffered Saline (PBS) diluent|0.006M PBS diluent for Influenza Virus Vaccine.
15888648|NCT03738228|Drug|Atezolizumab|Given IV
15888649|NCT03738228|Radiation|Brachytherapy|Undergo standard of care image guided brachytherapy
15888650|NCT03738228|Drug|Cisplatin|Given IV
15888651|NCT03738228|Radiation|Radiation Therapy|Undergo standard of care radiation therapy
15888652|NCT03738215|Drug|Cariprazine|Cariprazine supplied in capsules
15888653|NCT03738215|Drug|Placebo|Placebo supplied in capsules
15888654|NCT03738202|Behavioral|Multifaceted intervention package|"Multifaceted intervention package will comprise following strategies:
~Initial training for all workers and managers on occupational health and safety (OHS)
~Follow-up refresher sessions every three months
~Formation of workplace committees (including worker representatives) to draw up, agree and promote a health and safety plan that includes wet mopping, safe disposal of cotton dust, and the use of simple face masks, as well as further publicity about the risks from cotton dust.
~Provision of adequate supplies of face masks to support the health and safety plan"
15888655|NCT03738189|Other|Augmented Reality Video|Augmented Reality selfies will place a selection of denture teeth in pictures of the participants in order to enable the selection of their preferred teeth on their new denture.
15888656|NCT03738176|Drug|Sesame Oil|Sesame oil(80 gm NaCMC-20 gmSesame oil)
15888657|NCT03738176|Drug|triamcinolone in orabase|triamcinolone 140 gm-Na CMC 50 gm
15888658|NCT03738163|Device|Epaderm Cream|The treatment with the investigational device will be according to the prescription by the investigator together with the instruction stated on the investigational device.
15888659|NCT03738150|Biological|Sotatercept|Sotatercept injection
15888660|NCT03738137|Device|Narotrend|Narcotrend motoring
15888661|NCT03738137|Device|BIS|Bispectral index monitoring
15888662|NCT03738137|Drug|Sufentanil|sufentanil is applied.
15888663|NCT03738137|Drug|Lidocaine|Topical Anesthesia
15888664|NCT03738137|Drug|Midazolam|midazolam is applied.
15888665|NCT03738124|Device|Valiant Mona LSA Thoracic Stent Graft System|The Valiant Mona LSA device is a modular two-component system consisting of a main stent graft (MSG) and a branch stent graft (BSG), delivered separately, designed to maintain LSA perfusion. Briefly, under general anesthesia and after heparin injection, a MSG access is achieved via a femoral artery. A Through-and-through wire access for delivery of the BSG is achieved via a brachial artery. After the placement of the main aortic stent graft in the arch with the cuff at the level of the ostium of the LSA, the BSG is placed through a femoral access.
15888666|NCT03738111|Drug|TG02 Citrate|TG02 citrate capsules
15888667|NCT03738098|Behavioral|Standard of Care|Participants will receive traditional genetic counseling (GC) for the Baseline and Return of Results (ROR1) visits.
15888668|NCT03738098|Behavioral|GUÍA|GUÍA for the ROR1 visit.
15888669|NCT03738072|Diagnostic Test|StiMiC stimulation condition|This new condition of stimulation of electrical Brain Stimulation will be evaluate to determine if this stimulation is more efficient that standard stimulation condition
15888670|NCT03738059|Drug|Dexmedetomidine Injection [Precedex]|will receive intravenous Dexmedetomidine
15888671|NCT03738059|Other|normal saline 0.9%|will receive intravenous normal saline 0.9%
15888672|NCT03738046|Behavioral|Cognitive Behavioral Therapy|Group therapy will occur once weekly (60-90-minute sessions) at the HOPE TEAM offices for 24 weeks. The group sessions with consist of 4 skill modules, each of which last 6 sessions. Three of these--the Cognitive, Social Skills, and Problem-Solving Modules-will be modules taken from Cognitive and Behavioral Social Skills Training (CBSST; Granholm McQuaid, & Holden, 2016) and modified for use with CHR adolescents. The fourth module-Stress Coping-will be adapted for this sample from an established group CBT treatment for psychosis (Lecomte, Leclerc, & Wykes, 2016).
15888673|NCT03738033|Other|educational platform|The platform would be opened before they entered the study.
15888674|NCT03738020|Device|HA IDF (YVOIRE classic)|Treatment with HA IDF
15888675|NCT03738020|Device|Restylane|Treatment with Restylane
15888676|NCT03738007|Device|HA IDF II|Treatment with HA IDF II (YVOIRE volume)
15888677|NCT03738007|Device|Perlane|Treatment with Perlane
15888678|NCT03737994|Drug|Alectinib|Given PO
15888679|NCT03737994|Drug|Brigatinib|Given PO
15888680|NCT03737994|Drug|Carboplatin|Given IV
15888681|NCT03737994|Drug|Ceritinib|Given PO
15888682|NCT03737994|Drug|Cisplatin|Given IV
15888683|NCT03737994|Drug|Crizotinib|Given PO
15888684|NCT03737994|Drug|Ensartinib|Given PO
15888685|NCT03737994|Drug|Lorlatinib|Given PO
15888686|NCT03737994|Drug|Pemetrexed|Given IV
15888723|NCT03737695|Procedure|Biospecimen Collection|Undergo biospecimen collection
15888724|NCT03737695|Other|Medical Chart Review|Undergo clinical information collection
15888691|NCT03737968|Drug|Durvalumab|Patients in the durvalumab (MEDI4736) monotherapy treatment group will receive durvalumab (MEDI4736) (1500mg Q4W) once prior to surgery in this study. After surgical resection, these patients will receive the post op adjuvant treatment including RTx with/without cisplatin based on the pathologic findings and physician's discretion. After completion of adjuvant treatment, durvalumab (MEDI4736) 1500mg Q4W as maintenance treatment for up to a maximum of 12 months
15888692|NCT03737968|Drug|durvalumab + tremelimumab|Patients in the durvalumab (MEDI4736) + tremelimumab combination therapy treatment group will receive durvalumab (MEDI4736) (1500mg Q4W) in combination with tremelimumab (75 mg IV Q4W) once prior to surgery in this study. After surgical resection, these patients will receive the post op adjuvant treatment including RTx with/without cisplatin based on the pathologic findings and physician's discretion. After completion of adjuvant treatment, durvalumab (MEDI4736) 1500mg Q4W as maintenance treatment for up to a maximum of 12 months
15888693|NCT03737955|Drug|Gemtuzumab Ozogamicin|Receive IV
15888694|NCT03737955|Other|Quality-of-Life Assessment|Ancillary studies
15888695|NCT03737942|Device|monitoring of neuromuscular function|started by percutaneous stimulation of the cubital nerve at the wrist level
15888696|NCT03737929|Procedure|Hybrid ablation|In the hybrid ablation arm, the epicardial surgical ablation procedure will be combined with percutaneous endocardial catheter ablation procedure in a single step procedure (same operative time). During the endocardial approach, the isolation of the pulmonary veins and the posterior box will be checked and completed if necessary. Then additional ablation will be performed for atrial tachycardia or ongoing persisting atrial fibrillation (AF) according the same lesions setup or stepwise protocol than the conventional arm
15888697|NCT03737929|Procedure|Percutaneous catheter ablation|In the percutaneous catheter ablation arm, the procedure will be performed according to the current guidelines (pulmonary vein isolation, linear ablation and fragmented potentials ablation if needed, with the achievement of sinus rhythm during the procedure being the optimal endpoint. Any atrial tachycardia will be mapped and ablated as well (DC shock performed otherwise).
15888698|NCT03737916|Other|5 cc 5% Dextrose solution|Ultrasound-guided perineural injection with 5% Dextrose (1cc) to ulnar nerve into the elbow, 2 and 4 cm before and after the elbow (total 5 cc).
15888699|NCT03737916|Other|5 cc salin|Ultrasound-guided perineural injection with salin (1cc) to ulnar nerve into the elbow, 2 and 4 cm before and after the elbow (total 5 cc).
15888700|NCT03737890|Other|Inspiratory Muscle Training|"Participants in the experimental group were given Inspiratory Muscle Training by using an IMT device. For this training, the inspiratory load for each participant was set at 30 cmH2O.
~In control group, the participants received 3 sets of passive hold- relax pectoral stretch for each session. Each stretch was maintained for 10 seconds with a rest period of 30 seconds given between the sets.
~Each participant was supposed to complete a total of 12 sessions of exercises, 3 sessions per week for 4 weeks."
15888701|NCT03737890|Other|Hold Relax Pectoral Stretch|"In control group, the participants received 3 sets of passive hold- relax pectoral stretch for each session. Each stretch was maintained for 10 seconds with a rest period of 30 seconds given between the sets.
~Each participant was supposed to complete a total of 12 sessions of exercises, 3 sessions per week for 4 weeks."
15888702|NCT03737877|Other|Diet modification|"The parents will have four group sessions with a nutritional therapist, where in depth advice and information about the diet will be provided. Ongoing support will also be provided throughout the study by use of a closed Facebook or WhatsApp group (whichever the parents choose as most appropriate). The diet is based on five main principles:
~Eat at least seven portions of different varieties of fruit and vegetables each day.
~Have a 12 hour overnight break from food (water only during this time).
~Drink a Kefir drink each day - provided free of charge.
~Eat a microbiome friendly, protein rich, breakfast from our menu.
~Reduce sugar and artificial sweeteners."
15888703|NCT03737864|Behavioral|Patient navigation|The patient navigator will provide support to patients upon discharge and will maintain regular contact either in person or by phone at a minimum of once per week for 30 days, or until the patient successfully enrolled in substance abuse treatment, or readmission to detoxification occurs, whichever occurs first.
15888704|NCT03737864|Behavioral|Motivational interviewing (MI)|A single 45-60 minute 1:1 session of MI provided by patient navigators at discharged focused on transitioning patients to treatment after detoxification.
15888705|NCT03737851|Drug|elezanumab|solution for infusion
15888706|NCT03737851|Drug|placebo|solution for infusion
15888707|NCT03737838|Device|Atrial fibrillation ablation|High density mapping of left atrium using Rhythmia mapping system to identify gaps in conduction and wavefront discontinuities (deceleration zones)
15888708|NCT03737825|Device|Computerized gaming rehabilitation Program 1|Brain training games displayed on a large screen paired with physical exercise component. The program involves movements such as reaching, stepping, or stretching in place.
15888709|NCT03737825|Device|Computerized gaming rehabilitation Program 2|Brain training games displayed on a tablet device paired with physical exercise component. The program involves movements such as reaching, stepping, or stretching.
15888710|NCT03737812|Drug|elezanumab|solution for infusion
15888711|NCT03737812|Drug|placebo|solution for infusion
15888712|NCT03737786|Other|Tight control of end-tidal CO2 levels|The desired end-tidal PCO2 levels will be achieved by endotracheal intubation and controlled ventilation
15888713|NCT03737773|Other|glasses (prismatic lenses)|
15888714|NCT03737773|Other|glasses (neutral)|
15888715|NCT03737747|Procedure|induced hypothermia|
15888716|NCT03737734|Device|Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)|An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.
15888717|NCT03737721|Combination Product|Avelumab and Radical radiotherapy|A single-arm, interventional study combining Avelumab with radical radiotherapy. Avelumab will be delivered on a 14-day cycle, with the first cycle administered 14 days in advance of the radiation therapy start date; 63-66 Gy radiation will be delivered over 30 daily fractions concurrent with an additional 4 cycles of Avelumab
15888718|NCT03737708|Drug|tacrolimus|Administered orally
15888719|NCT03737708|Drug|methotrexate|Administered orally
15888720|NCT03737708|Biological|adalimumab|Administered as subcutaneous injection
15888721|NCT03737708|Biological|tocilizumab|Administered by intravenous injection
15888722|NCT03737708|Biological|abatacept|Administered by intravenous injection
15888725|NCT03737682|Diagnostic Test|ENzyme linked immunity-sorbet assays|Hemostasis achievement reflecting inflammatory status of the pulp based on cytokine levels
15888726|NCT03737669|Biological|Mirasol-treated Fresh Whole Blood|Standard issue FWB, which gave negative serological assay results for HIV, HBV, HCV, and syphilis will subsequently be treated with Mirasol PRT, then stored at 1 - 6 degrees Celsius and transfused within 21 days of collection.
15888727|NCT03737669|Biological|Standard Fresh Whole Blood|Fresh whole blood that gave negative serological assay results for HIV, HBV, HCV, and syphilis will be stored at 1 - 6 degrees Celsius and transfused within 21 days of collection.
15888728|NCT03737656|Drug|Progesterone vaginal ring|Vaginal ring with 2.0 g progesterone (sustained-release over 90-days)
15888735|NCT03737630|Device|Inspiratory muscle training|This group will initiate inspiratory muscle training with 40% of the MIP load and each week will have a load increase of 10% of the initial MIP up to 4 weeks of training
15888736|NCT03737617|Drug|Cuvitru 20 % Injectable Solution|Active
15888737|NCT03737604|Drug|Ropivacaine Continuous Infusion Catheter|For those randomized to the TAP catheter group, ultrasound guidance will be used for TAP block and 5mls 1% lidocaine will be used for skin infiltration. A peripheral nerve catheter will be placed approximately 3-5 cm into the TAP space after injection of the ropivacaine solution. A bolus dose of 2.5 mg/kg of ropivacaine will be administered in a volume of 30 ml up to a maximum of 150 mg. An infusion with a programmable pump will be initiated at a rate of 8 ml/hr of 0.2% ropivacaine on the inpatient floor.
15888738|NCT03737604|Drug|Single Dose Liposomal Bupivicaine|TAP block will be performed using ultrasound guidance. 12ml of 0,25% plain bupivacaine will be used for skin infiltration and to open up the TAP. Liposomal bupivacaine 266 mg (1.3% in 20 ml) will be diluted to 40 ml volume with 20 ml of preservative free normal saline. 20 ml (133mg) of liposomal bupivicaine will then be injected into the TAP.
15888739|NCT03737591|Diagnostic Test|Next-generation sequencing (NGS)|NGS test for colorectal tumor-specific plasma ctDNA methylation markers prior to endoscopy
15888740|NCT03737578|Other|Delivery of a connected pedometer / accelerometer|"Delivery of a connected pedometer / accelerometer that the patient will be asked to wear at least 7 consecutive days / month.
~Quality of life and leg restless syndrome questionnaires (auto questionnaire) completed by the patients every 3 months"
15888741|NCT03737565|Device|Optimax stent®|Percutaneous coronary intervention with Optimax stent®
15888742|NCT03737552|Other|Polysomnography|Polysomnography Is considered as the gold standard of sleep assessment. It combines a number of measures of body function during sleep, including measurement of brain activity(electroencephalography),eye movements(electrooculography ),muscle activity (electromyography),heart rhythm(electrocardiography).
15888743|NCT03737539|Diagnostic Test|Multigene methylation detection|Colorectal tumor-specific plasma ctDNA methylation markers detection
15888744|NCT03737500|Device|B-Lite® light weight breast implant|Definitive breast reconstruction after total mastectomy by the use of B-Lite® light weight breast implant
15888745|NCT03737500|Device|Standard silicone-based breast implant|Definitive breast reconstruction after total mastectomy by the use of silicone-based breast implants commonly used in our institution
15888746|NCT03737487|Procedure|Multidisciplinary fall risk and geriatric comprehensive assessment|"Complete blood count, serum electrolytes, C-Reactive Protein, transaminases and gamma-glutamyl transferase, thyroid-stimulating hormone, and 25OH vitamin D.
~Calculation of BMI
~A 40-min assessment of balance, walking speed, muscle strength, activity, and functional status by a physiotherapist
~A 40-min assessment by an occupational therapist, including a detailed questionnaire on social support, living situation and home environment, fear of falling, and cognitive function
~A 20-min assessment by a podiatrist including an examination of the patient's feet and footwear.
~A 60-min assessment by a geriatrician including assessment of circumstances of the previous fall(s), review of current medications and medical history, and an in-depth examination of the patient to detect possible contributors or risk factors for falling
~A 20-min review meeting with the 4 healthcare professionals in order to prioritize recommendations to be provided."
15888747|NCT03737474|Drug|Brexpiprazole|2 mg/day (starting dose 1mg/day) of Brexpiprazole will be orally administered once daily
15888748|NCT03737461|Drug|Allogenic BM-MSCs Injection|Cell dose will be 20±5 million cells suspended in 2 ml of HypoThermosol isotonic transport solution
15888749|NCT03737461|Other|Sham Procedure|sham-maneuver as in the cell-treated patients are added, consisting in anesthetic infiltration with 2 ml of 1% xylocaine in the paravertebral muscles close to the affected segment.
15888750|NCT03737448|Drug|Trimetazidine|Subjects with receive up to 60 mg daily
15888751|NCT03737422|Dietary Supplement|hesperidin and flaxseed|2 capsuls hesperidin and 30 g flaxseed
15888752|NCT03737422|Other|control|no supplementation
15888753|NCT03737409|Other|Ambulatory Oxygen Therapy|Supplemental oxygen delivered during exercise and activities of daily living via a portable oxygen concentrator
15888754|NCT03737409|Other|Sham Ambulatory Oxygen Therapy|Air delivered during exercise and activities of daily living via a portable oxygen concentrator that has been modified to deliver air
15888755|NCT03737396|Procedure|Self-administered electronic health screening|Health assessment using an electronic device
15888756|NCT03737383|Behavioral|Narrative Exposure Therapy|brief, trauma-focused treatment.
15888757|NCT03737370|Drug|Docetaxel|Docetaxel will be administered every 2 weeks (on Day 1 and Day 15 of a 28 day cycle). Fractionated dosing dependent on cohort.
15888758|NCT03737370|Radiation|Radium 223|Radium 223 will be delivered every 28 days (on day 1) for 6 cycles.
15888790|NCT03737162|Procedure|Stent implantation of subclavian artery|Stent implantation of subclavian artery
15888870|NCT03736603|Behavioral|PIPA Intervention Bundle 1|"The PIPA intervention bundle 1 includes:
~Pathway Implementation Toolkit
~Local Multidisciplinary Champions
~Audit and Feedback
~Educational Seminars/Webinars
~Practice Facilitation"
15898513|NCT03661320|Drug|BMS-986205 Placebo|Specified dose on specified day
15888759|NCT03737357|Device|SLActive® implant|One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.
15888760|NCT03737357|Device|SLA® implant|One study test (SLActive® surface) (and simultaneously, in a split-mouth design one study control (SLA® surface) implant (Bone Level Tapered, Roxolid®)) will be placed in two different quadrants of partially edentulous patients. The implants will be placed at premolars, molars and canine positions in the mandible and maxilla (healed extraction sites). Implants will be restored with a single crown or splinted restorations 8 weeks after implant placement.
15888761|NCT03737344|Drug|IL-1Ra Kineret®|Kineret® 100 mg in 0.67 ml Prefilled Syringe
15888762|NCT03737344|Other|IL-1Ra Placebo|Placebo identical to Kineret® 100 mg in 0.67 ml Prefilled Syringe
15888763|NCT03737331|Behavioral|Fractal visual cueing|Walking to an external visual fractal (i.e., pink noise) stimulus.
15888764|NCT03737331|Behavioral|Periodic visual cueing|Walking to an external visual periodic (i.e., invariant) stimulus.
15888765|NCT03737331|Behavioral|Random visual cueing|Walking to an external visual random (i.e., white noise) stimulus.
15888766|NCT03737318|Behavioral|Biofeedback-ultrasound|In ultrasound biofeedback, the elements of traditional treatment (auditory models and verbal descriptions of articulator placement) are enhanced with a real-time ultrasound display of the shape and movements of the tongue. One or two target tongue shapes will be selected for each participant, and a trace of the selected target will be superimposed over the ultrasound screen. Participants will be cued to reshape the tongue to match this target during /r/ production.
15888767|NCT03737318|Behavioral|Biofeedback--visual-acoustic|In visual-acoustic biofeedback treatment, the elements of traditional treatment (auditory models and verbal descriptions of articulator placement) are enhanced with a dynamic display of the speech signal in the form of the real-time LPC (Linear Predictive Coding) spectrum. Because correct vs incorrect productions of /r/ contrast acoustically in the frequency of the third formant (F3), participants will be cued to make their real-time LPC spectrum match a visual target characterized by a low F3 frequency. They will be encouraged to attend to the visual display while adjusting the placement of their articulators and observing how those adjustments impact F3.
15888768|NCT03737318|Behavioral|Traditional articulation treatment|Traditional articulation treatment involves providing auditory models and verbal descriptions of correct articulator placement, then cueing repetitive motor practice. Images and diagrams of the vocal tract will be used as visual aids; however, no real-time visual display of articulatory or acoustic information will be made available.
15888769|NCT03737305|Device|TMJ Condilar Distraction Device|The patients will perform condylar distraction with the condylar distraction device in an ambulatory basis.
15888770|NCT03737305|Device|Conventional Physical Therapy|Conventional Physical Therapy, performed in office by a experienced physical therapist for the TMJ condition.
15888771|NCT03737292|Drug|Exparel|The intercostal blocks will be performed at several levels corresponding to the incisions and chest tube insertion sites + two levels above and two levels below the incisions. On average, 5-6 intercostal spaces will be injected with 4-5 ml of local anesthetic at each level.
15888772|NCT03737292|Drug|Bupivacaine|The intercostal injections of 0.5% Bupivacaine 2 mg/kg dose diluted to 30 ml total will be performed at several levels corresponding to the incisions and chest tube insertion sites + two levels above and two levels below the incisions.
15888773|NCT03737279|Behavioral|Meditation|Routine care + twice daily meditation per schedule, to start on the day of randomization
15888774|NCT03737279|Behavioral|Routine Care|"Routine care including ACOG educational pamphlets:
~Day 1: Nutrition in Pregnancy
~Day 2: Heart Health for Women
~Day 3: Exercise after Pregnancy"
15888775|NCT03737266|Procedure|Sonographically assisted breast surgery|Sonography
15888776|NCT03737266|Procedure|Conventional breast surgery|Conventional
15888777|NCT03737253|Drug|Follitropin alpha|The objective is to measure the effect of the drug according to gonadotropin receptor genotype.
15888778|NCT03737253|Drug|Menotropin|The objective is to measure the effect of the drug according to gonadotropin receptor genotype.
15888779|NCT03737240|Drug|IDegLira|Participants in this study arm will discontinue all other diabetes medications, except for metformin which will be continued at prescribed dose (unless contraindicated). IDegLira will be given once daily, at the same time of the day with or without food for 26 weeks. IDegLira will be titrated until the maximum dose is reached, up to the target fasting blood glucose of 70 to 100 milligrams per deciliter (mg/dL).
15888780|NCT03737240|Drug|Insulin Degludec (U-100)|Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin Degludec (U-100) will be given once daily at the same time for 26 weeks. The dose will be titrated up to the fasting blood glucose target of 70 to 100 mg/dL, with no maximum dose.
15888781|NCT03737240|Drug|Insulin Aspart|Participants in the basal-bolus insulin study arm will discontinue all other diabetes medications, except for metformin which will be continued at the prescribed dose (unless contraindicated). Insulin aspart will be taken before meals with a titration schedule and dose adjustment protocol to target pre-meal blood glucose level of 70 to 100 mg/dL.
15888782|NCT03737227|Radiation|Cinematographic recording|Cinematographic recording during flexion and extension of the lumbar spine.
15888783|NCT03737214|Drug|Lucerastat|Administered in hard gelatin capsules containing 250 mg of lucerastat.
15888784|NCT03737201|Other|ozone|In the two-visit indirect pulp therapy, due to reduce the number of bacteria remaining in the cavity, the antimicrobial agents can be used as cavity disinfectants such as ozone.
15888785|NCT03737201|Other|chlorhexidine digluconate|In the two-visit indirect pulp therapy, due to reduce the number of bacteria remaining in the cavity, the antimicrobial agents can be used as cavity disinfectants such as chlorhexidine digluconate.
15888786|NCT03737201|Other|Control|without any cavity disinfectant
15888787|NCT03737188|Device|Blood glucose monitoring systems for self-testing|Capillary blood samples will be used for the evaluation of system accuracy.
15888788|NCT03737175|Procedure|Carotid Artery Stenting|Carotid Artery Stenting
15888789|NCT03737175|Procedure|Carotid Endarterectomy|Carotid Endarterectomy
15888791|NCT03737149|Other|mymobility with Apple Watch|The mymobility mobile application is a mobile software platform designed to facilitate remote episode of care management and asynchronous communication between the provider care team and their patient via provider-approved care plans and engagement communications. Current care pathways have been developed for: Total Hip Replacement, Total Knee Replacement and Partial Knee Replacement. Designed for the orthopedic population, mymobility also integrates wearable data from the Apple Watch into provider dashboards, providing enhanced understanding and monitoring of patients throughout the episode of care.
15888792|NCT03737136|Drug|Bortezomib|one cycle of bortezomib (each cycle: 1.3mg/m2 intravenously on days 1, 4, 8, and 11)
15888793|NCT03737123|Drug|Carboplatin|Carboplatin AUC 4 IV Day 1 of each 21 day cycle
15888794|NCT03737123|Drug|Gemcitabine|Gemcitabine 1,000 mg/m2 IV Day 1 and Day 8 of each 21 day cycle
15888795|NCT03737123|Drug|Atezolizumab|Atezolizumab 1,200 mg IV Day 1 of each 21 day cycle
15888796|NCT03737123|Drug|Docetaxel|Docetaxel 75 mg/m2 IV Day 1 of each 21 day Cycle.
15888797|NCT03737110|Drug|Rilonacept|Rilonacept 320 mg (or 4.4 mg/kg in pediatric participants ≥12 and <18 years old) SC , followed by 160 mg (or 2.2 mg/kg in pediatric participants ≥12 and <18 years old) injections once weekly
15888798|NCT03737110|Drug|Placebo|Placebo SC injections once weekly
15888799|NCT03737097|Other|Online Spaced Education|Investigators created a set of fall prevention strategies for multiple sclerosis patients into an evidence-based form of online education, termed 'spaced education' (SE). Based upon two psychology research findings (the spacing and testing effects), spaced education has been shown in randomized trials to improve knowledge acquisition, boosts learning retention for up to two years, and durably improves changes in behavior.
15888800|NCT03737097|Other|Brochure Education|The investigators translated and validated the Minimizing Your Risk of Falls A GUIDE FOR PEOPLE WITH MS brochure developed by the National Multiple Sclerosis Society. The control cohort will receive the main education model for patients that has been used in the past few years.
15888801|NCT03737084|Behavioral|CBCT Intervention|The training consists of six weekly sessions. The participant will receive six guided meditation audio, relative to each session, to practice during the week.
15888802|NCT03737071|Behavioral|Low Carbohydrate Diet|Ketogenic dietary intervention
15888803|NCT03737058|Behavioral|Program participants|The intervention is a 12-month telephonic program in which a lay health worker (LHW), supervised on-site by a registered nurse practitioner (RNP), assessed patient symptoms after diagnosis using the validated Edmonton Symptom Assessment Scale (ESAS) (cite) with the frequency of symptom assessment varying based on patient risk.
15888804|NCT03737045|Other|Decision Aid|Participants will test decision aid prototypes that are designed to assist them in choosing a medication.
15888805|NCT03737032|Device|Intermittent Theta Burst Stimulation|Theta Burst Stimulation, a form of Transcranial Magnetic Stimulation, will be applied to the dorsomedial prefrontal cortex. will include 600 pulses delivered in brief bursts of three pulses with a frequency of 50 Hz, at an intensity of 110% of resting motor threshold, and administered every 200 ms (5 Hz). Bursts will be delivered without interruption for a total duration of 40 seconds.
15888806|NCT03737032|Device|Continuous Theta Burst Stimulation|Theta Burst Stimulation, a form of Transcranial Magnetic Stimulation, will be applied to the dorsomedial prefrontal cortex. will include 600 pulses delivered in brief bursts of three pulses with a frequency of 50 Hz, at an intensity of 110% of resting motor threshold, and administered every 200 ms (5 Hz). Bursts will be delivered during 2 second periods (10 bursts/period) interleaved with 8-second stimulation-free intervals, for a total duration of 190 seconds.
15888807|NCT03737032|Device|Sham Theta Burst Stimulation|For the sham of theta burst stimulation, the device providing Theta Burst Stimulation can be placed in the same position and turned on, creating a similar experience for the participant, without providing any neural stimulation. Sham TBS will be delivered with a Cool-B65 Active/Placebo Coil, which includes a sham setting, and MagLink research software.
15888808|NCT03737019|Behavioral|Education with Acceptance and Commitment Therapy|Group education with Acceptance and Commitment Therapy of the personnel at each center.
15888809|NCT03737019|Other|Control, no intervention|Control, no interventions.
15888810|NCT03736993|Other|Additional blood sampling|Establish predictive markers for early disease progression after complete surgical resection in patients with stage I to IIIA NSCLC.
15888811|NCT03736980|Drug|Placebo|100% lactose
15888812|NCT03736980|Drug|Psilocybine|Study Group 1: 0.250 mg/Kg weight Study Group 2: 0.200 mg/Kg body weight Study Group 3: 0.215 mg/Kg body weight Study Group 4: 0.315 mg/Kg body weight
15888813|NCT03736967|Drug|REGN3500|Administered subcutaneous (SC) every 2 weeks (q2w)
15888814|NCT03736967|Drug|Dupilumab|Administered SC q2w
15888815|NCT03736967|Drug|REGN3500 + Dupilumab Combo|Administered SC q2w
15888816|NCT03736967|Drug|Placebo|Administered SC q2w
15888817|NCT03736954|Behavioral|positive suggestion|humanization of critical care experience with positive reframing of hospital course on daily basis to eligible participants
15888818|NCT03736941|Other|Patients with venous leg|The medical device Venotrain® Ulcertec will be prescribed according to the indications supported by the Health Insurance and used according to the recommendations of the manufacturer. It will be dispensed in town pharmacies. After inclusion, follow-up visits are scheduled at 4, and 16 weeks (± 1 week) as well as an end-of-study visit, not later than 20 weeks after enrollment or in case of premature termination. follow-up.
15888819|NCT03736928|Biological|AbobotulinumtoxinA dose level 1 or 2|Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
15888820|NCT03736928|Other|placebo|Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
15888821|NCT03736928|Biological|AbobotulinumtoxinA dose 3|Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
15888822|NCT03736928|Biological|AbobotulinumtoxinA dose 4|Intramuscular; 0.05 mL per injection site; single treatment of glabellar facial lines
15888823|NCT03736915|Procedure|Injection using 1 cc of NaCl 0.9%|The injection will be using SIMPLE block technique using 1 cc of NaCl 0.9% solution under the injection speed of 30 seconds/cc.
15888824|NCT03736915|Other|Patient Preference Question|Patient is asked at the end of each injection which injection they prefer
15888825|NCT03736915|Other|Questionnaires|Patient is asked to answer questionairres at the end of each injection
15888861|NCT03736616|Drug|Carboplatin|Chemotherapy
15888826|NCT03736902|Other|Qualitative semi structured interview|One-to-one semi structured interviews, guided by the Physical Activity for people with a Disability Framework (van der Ploeg et al, 2004) which is a model for understanding the different factors that influence whether people with a disability engage in physical activity. Participants that agree to take part in the study, will be offered an interview either in a private clinic room at the hospital, at their home (if they live within a 40-mile radius of the hospital) or via a web-based video link. The interviews are expected to last one hour and will be conducted by the primary researcher.
15888827|NCT03736889|Drug|Tislelizumab (BGB-A317)|Anti-PD-1 Antibody
15888828|NCT03736876|Behavioral|About Us|Each program session includes an initial soap opera-like story to build interest and illustrate key concepts, 2-3 group-based activities with reflection, individual app-based work on tablets to allow for personalization of the content, and a group-based debrief to reflect on the day and reinforce key messages. The group-based content is delivered by trained facilitators from the participating school-based health centers. The app-based content is housed on a secure website and accessed through tablets with unique log-ins for each participant. Activities are completed individually during the session (e.g., completing a poll; watching and responding to a brief video). Several lessons include homework activities that encourage communication between students and a caring adult.
15888829|NCT03736863|Drug|Apatinib+ SHR-1210（Camrelizumab）|Apatinib 250mg, q.d.po+SHR-1210（Camrelizumab） 200 mg，Intravenous injection， q2W continuous medication，A course of treatment need 28 days.
15888830|NCT03736850|Drug|CS3006|"In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme.
~In the dose expansion part, participants will receive CS3006 at specified dose level(s)."
15888831|NCT03736837|Drug|Anlotinib Plus Icotinib|"Anlotinib：12mg/capsule, take once when limosis in the morning. If patients suffer from AEs, they can get declined dosage (10mg or 8mg).
~Icotinib：125 mg/tablet，three times a day，fasting or serving with food. It should be continued until disease progression or intolerable toxicity or patients withdraw of consent."
15888832|NCT03736824|Procedure|endoscopy|All endoscopy was performed by qualified gastroenterologists or endoscopic physicians in Renji hospital,Shanghai Jiaotong University School of Medicine.
15888833|NCT03736811|Device|Polyglactin 910 or polydioxanone|Vicryl or PDS II
15888834|NCT03736811|Device|Polyester or polypropylene|Ethibond Excel or prolene
15888835|NCT03736785|Drug|LY3209590|Administered SC
15888836|NCT03736785|Drug|Insulin Degludec|Administered SC
15888837|NCT03736772|Drug|LY3090106|Administered SC
15888838|NCT03736772|Drug|Placebo|Administered SC
15888839|NCT03736759|Behavioral|Exercise|10 sets of 5 repetitions of 80% of calculated one-repetition maximum weight of lateral side arm raise and biceps curls, alternating
15888840|NCT03736746|Behavioral|Motivational Interviewing|An investigator-led discussion about the participant's pain experience which is focused on the participant reporting of functional pain goals (FPGs)
15888841|NCT03736733|Other|physical activity program|"Two weekly exercise sessions at the university hospital of St-Etienne for 1 month then relay outside in a sports association or club certified Sports Health in the Loire (42) or Haute-Loire (43) for 2 months."
15888842|NCT03736733|Other|Advice and recommendations of physical activity at home|Advice and recommendations of physical activity at home (= current clinical practice, from 1 to 3 sessions per week in autonomy).
15888843|NCT03736720|Drug|Fluorouracil|Given IV
15888844|NCT03736720|Drug|Leucovorin|Given IV
15888845|NCT03736720|Drug|Liposomal Irinotecan|Given IV
15888846|NCT03736720|Procedure|Quality-of-Life Assessment|Correlative studies
15888847|NCT03736707|Device|Selective HFOV|Selective HFOV will only be provided with piston/membrane oscillators able to provide a real oscillatory pressure with active expiratory phase
15888848|NCT03736707|Device|CMV|CMV was delivered by time-cycled, pressure-limited ventilators
15888849|NCT03736694|Behavioral|Cognitive behavioural therapy for insomnia|CBTI involves habitual, belief and attitude alterations so as to eliminate factors preventing sleep (Morin, Savard, Ouellet, & Daley, 2003). It is recommended by the American College of Physicians as the first-line therapy for insomnia (Qaseem, Kansagara, Forciea, Cooke, & Denberg, 2016). CBTI workshops are a relatively novel and emerging way of delivery which involves a greater number of patients than group CBTI, increases availability and accessibility by concentrating the content into half or whole day and taking place in the community settings, and reduces diagnostic labeling and cost (Bonin, Beecham, Swift, Raikundalia, & Brown, 2014; Swift, Stewart, Andiappan, Smith, Espie, & Brown, 2012). Self-help CBTI involves independent learning of the provided materials via the Internet, video or audio recording, books and pamphlets (Bruin, Bogels, Oort, & Meijer, 2015).
15888850|NCT03736694|Behavioral|Sleep hygiene education|SHE, is commonly provided verbally or through leaflets during consultations (Espie, 2009), and is also included as a part of CBTI (Morin, Savard, Ouellet, & Daley, 2003).
15888851|NCT03736681|Drug|40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block|Women undergoing D&C in the first trimester for either surgical abortion or miscarriage management will receive 40cc buffered 0.5% lidocaine with 2 units of vasopressin paracervical block before cervical dilation.
15888852|NCT03736681|Drug|20cc 1% lidocaine with 2 units of vasopressin paracervical block|Women undergoing D&C in the first trimester for either surgical abortion or miscarriage management will be randomly assigned to receive 20cc 1% lidocaine with 2 units of vasopressin paracervical block before cervical dilation.
15888853|NCT03736668|Diagnostic Test|echocardiography|One year after patient's inclusion, an echocardiography / doppler will be performed to evaluate any changes.Two years after the patient's inclusion, an investigating cardiologist will contact the physician, cardiologist and / or diabetologist treating the patient by telephone to find out if any cardiovascular events have occurred.
15888854|NCT03736655|Device|Interposition supraciliary implant|Surgical placement of an interposition supraciliary implant in the supraciliary space
15888855|NCT03736642|Biological|blood sampling|12 ml sample
15888856|NCT03736642|Other|stool sampling|20 g sample
15888857|NCT03736642|Other|urine sampling|18 ml sample
15888858|NCT03736642|Diagnostic Test|neuropsychological tests|"Go-nogo
~flexibility
~food stroop
~implicit and explicit evaluation
~Child Depression Inventory
~Hamilton Depression Rating Scale"
15888871|NCT03736603|Behavioral|PIPA Intervention Bundle 2|"The PIPA intervention bundle 2 includes:
~Pathway Implementation Toolkit
~Local Multidisciplinary Champions
~Audit and Feedback
~Educational Seminars/Webinars
~Practice Facilitation
~Mobile App"
15888872|NCT03736590|Behavioral|Financial coaching and services|The intervention will consist of clinic-based financial coaching that focuses on improving financial stability through longitudinal visits with financial services professionals to address financial goals.
15888873|NCT03736577|Other|Drug reviews with NorGeP-NH|Physicians in the intervention group will attend a 1-2 hours lecture about psychopharmacology and drug review. They will learn how to do drug reviews with the Norwegian general practice criteria - Nursing homes (NorGeP-NH). The nursing home physicians will do the drug review on the participants' drug charts
15888874|NCT03736564|Combination Product|68Ga-DOTATATE PET/CT|Gallium-68 Dotatate, a radioactive imaging agent, is injected into a vein. Subjects will rest for approximately 50 minutes, after which approximately a 30 minute image of subjects body will be completed via PET/CT scan.
15888875|NCT03736551|Behavioral|5:2 diet|very low energy diet (600 kcal/day) on 2 consecutive days of the week, and 5 days each week on an energy restricted diet to maintain a similar overall energy deficit of 600 kcal/day across the week (5:2 diet)
15888876|NCT03736551|Behavioral|Renal Weight Management Programme|Dietary intervention includes a standard continuous energy restricted diet aimed at reducing daily energy intake by 600 kcal/day relative to their estimated total energy expenditure. In addition to the dietary intervention, the programme also includes personal exercise plans, optional pharmacotherapy (orlistat at standard dose), and development of personalised dietary and exercise goals using behavioural therapy techniques and motivational interviewing.
15888877|NCT03736538|Drug|Nitrous Oxide|Nitrous oxide, an odorless, colorless gas typically used as an induction agent for general anesthesia or for dental sedation, is a known N-methyl-D-aspartate (NMDA) antagonist. It will be given at 50% nitrous oxide/50% oxygen in this study.
15888878|NCT03736538|Drug|Placebo gas|Placebo gas given at 50% nitrogen [inert]/50% oxygen.
15888879|NCT03736525|Behavioral|Design For Wellness (DWELL)|Design for wellness is an online Facebook intervention. During 3 months intervention period, participants in the intervention group will be exposed to contents on their newsfeed (posts on Facebook wall), and also be expected and encouraged to create new content themselves. The contents will be interactive and involve different modes of delivery, as audio and video, to reinforce active learning. Participants will be part of DWELL Facebook group community and will be empowered to read and control cues in the environment, by developing skills to enhance their self-efficacy.
15888880|NCT03736525|Behavioral|Wait list control group|Wait list control group will get no intervention during the study period. Participants will answer questionnaires pre, mid and post intervention. A delayed form of the intervention will be available to them after the close of the study.
15888882|NCT03736473|Drug|MEDI9447 (oleclumab)|MEDI9447 administered intravenously
15888883|NCT03736460|Behavioral|Mindfulness|The mindfulness-based intervention adheres to a standardized protocol developed from the MBSR curriculum (Kabat-Zinn, 1990). The program consists of four 3h group sessions spread over 8 weeks. Each session consists of guided experiential mindfulness exercises (e.g. focus on the breath, body scan, breathing space, mindful movement, sitting meditation), sharing of experiences of these exercises, reflection in small groups, psycho-education (e.g. stress, depression, fear of cancer recurrence, self-care) and review of home practices.
15888884|NCT03736460|Behavioral|Physical training|This intervention is based on the recommended levels of physical activity for adults aged 18 - 64 year from the World Health Organization. These recommendations are the same for women after a breast cancer treatment (Schmitz et al., 2010). Just as the mindfulness intervention this will consist of four 2h group sessions spread over 8 weeks. Each session will consist of psycho-education (e.g. basics of movement, advantages of physical activity, training-principles), endurance and resistance training, stretching, balance and relaxation exercises, sharing of experiences of these exercises and review of home practices.
15888885|NCT03736447|Biological|AR101 powder|AR101 powder provided in capsules and sachets (peanut allergen formulation)
15888886|NCT03736447|Biological|Placebo powder|Placebo powder provided in capsules and sachets
15888887|NCT03736434|Behavioral|Mindfulness and DASH Diet Education|"Mindfulness and DASH diet education will include a didactic presentation on stress, theoretical material related to mindfulness, the somatic mind/body connection, relaxation, yoga, meditation, self-awareness, and bodily cues relating to emotional reactivity. Practices will include the body scan, gentle yoga movement, walking/sitting meditation, breathing, relaxation. Additionally, daily 20 min individual practices are done at least 5x/week delivered via a compact disc player or on a preloaded device. Each participant is asked to track his/her daily meditation practice and given a diary for adherence records. A combination of didactic, experiential, and hands-on activities will be done to deliver DASH diet guidelines."
15888888|NCT03736434|Behavioral|Education group|The attention control group will attend eight, 2.5 hours sessions on non-health topics such as personal safety, fire prevention, cold weather protection, disaster preparation, internet safety, aging in place, how to know when it's time to move and managing your money.
15888889|NCT03736421|Procedure|Peripheral Intravenous Analysis (PIVA)|Non-invasive measurement of peripheral intravenous waveform analysis (PIVA) obtained by connecting an Edwards standard transducer to a universal adaptor or stopcock on a peripheral IV
15888890|NCT03736421|Procedure|Non-invasive fluid response measure|To measure the stroke volume and changes in stroke volume in response to a passive leg raise (PLR) maneuver and fluid administration.
15888891|NCT03736421|Diagnostic Test|Passive leg raise (PLR)|Test to predict cardiac output and fluid responsiveness
15888892|NCT03736395|Behavioral|Idaho Rural Implementation Model|The Idaho Rural Implementation Model (I-RIM) includes several aspects to support implementation of schoolwide positive behavioral interventions and supports (SWPBIS). In the first year, schools will send a staff member to a coaching institute to build internal capacity. Schools will also receive technical assistance (on-site twice per year and virtual support as needed). Schools will also receive statewide professional learning opportunities, through one group meeting per year, and through access to an invitation-only professional learning community.
15888893|NCT03736395|Behavioral|Control|Schools in this condition will receive a four-day training session about SWPBIS.
15890027|NCT03727061|Biological|Pembrolizumab|Immunotherapy - Standard of care
15888894|NCT03736382|Other|Mild intermittent hypoxia|Participants will be exposed to twelve two minute episodes of mild intermittent hypoxia 5 days a week for 3 weeks.
15888895|NCT03736382|Other|Sham protocol|Participants will be exposed to twelve two minute episodes of sham mild intermittent hypoxia (i.e. room air) 5 days a week for 3 weeks.
15888896|NCT03736382|Other|Continuous positive airway pressure (CPAP)|All participants will be treated with CPAP each night for a duration of 3 weeks.
15888897|NCT03736369|Drug|DWP14012 40mg|DWP14012 40mg, tablet, orally, once daily for up to 8 weeks
15888898|NCT03736369|Drug|DWP14012 40mg placebo|DWP14012 40mg placebo-matching tablet, orally, once daily for up to 8 weeks
15888899|NCT03736369|Drug|Esomeprazole 40mg|Esomeprazole 40mg tablet, orally, once daily for up to 8 weeks
15888900|NCT03736369|Drug|Esomeprazole 40mg placebo|Esomeprazole 40mg placebo-matching tablet, orally, once daily for up to 8 weeks
15888901|NCT03736343|Drug|Alcohol|Participants will complete two drinking sessions.
15888902|NCT03736330|Biological|Combinations treatment|Autologous dendritic and cytokine-induced killer cells (D-CIK)(1.0-1.5*10^10 cells)were incubated with low dose anti-PD-1 antibody（pembrolizumab, Merck & Co., Inc.） and were transferred to participants via intravenous infusion .
15888903|NCT03736317|Device|sham TBS|Stimulate the dorsal lateral prefrontal cortex or medial prefrontal cortex for 2 weeks by sham Theta-burst stimulation (TBS), five times for a week with the sham coil.
15888904|NCT03736317|Device|real mPFC cTBS|Stimulate the medial prefrontal cortex with the cTBS pattern. The therapy will be conducted for 2 weeks and five times for a week.
15888905|NCT03736317|Device|real dlPFC iTBS|Stimulate the dorsal lateral prefrontal cortex with the iTBS pattern. The therapy will be conducted for 2 weeks and five times for a week.
15888906|NCT03736317|Device|real dlPFC iTBS + real mPFC cTBS|Stimulate the dorsal lateral prefrontal cortex with the iTBS pattern, and stimulate medial prefrontal cortex with the cTBS pattern. The therapy will be conducted for 2 weeks and five times for a week.
15888907|NCT03736304|Device|AKI alert|An AKI alert will send to the doctor in charge. The team of nephrologists would give suggestions if the doctor in charge need a renal consultation.
15888908|NCT03736304|Other|Usual care|Patients will receive standard clinical care by the doctor in charge.
15888909|NCT03736291|Device|Repetitive transcranial magnetic stimulation|Repetitive Transcranial Magnetic Stimulation (rTMS) is a widely used non-invasive neuromodulation technique that induces excitatory changes in the cerebral cortex stimulated by repeated pulsed magnetic fields on the scalp.
15888910|NCT03736278|Other|No intervention|We group the patients according to the outcome (survival vs mortality)
15888911|NCT03736265|Drug|Carvedilol|Carvedilol is started at a dose of 6.25 mg once daily. After 1 week, this will increased to a dose of 12.5 mg once daily. Target dose of 12.5 mg once daily will be maintained if systolic blood pressure does not fall below 90 mm Hg and HR 50 beats per minute.
15888912|NCT03736252|Device|Orthosis provision|Hely and Weber CMC controller
15888914|NCT03736213|Behavioral|Biofeedback--visual-acoustic|In visual-acoustic biofeedback treatment, the elements of traditional articulatory treatment (i.e., auditory models and verbal descriptions of articulator placement) are enhanced with a dynamic display of the speech signal in the form of the real-time LPC (Linear Predictive Coding) spectrum. Because correct vs incorrect productions of /r/ contrast acoustically in the frequency of the third formant (F3), participants will be cued to make their real-time LPC spectrum match a visual target characterized by a low F3 frequency. They will be encouraged to attend to the visual display while adjusting the placement of their articulators and observing how those adjustments impact F3.
15888915|NCT03736213|Behavioral|Biofeedback-ultrasound|In ultrasound biofeedback, the elements of traditional articulatory treatment (i.e., auditory models and verbal descriptions of articulator placement) are enhanced with a real-time ultrasound display of the shape and movements of the tongue. One or two target tongue shapes will be selected for each participant, and a trace of the selected target will be superimposed over the ultrasound screen. Participants will be cued to reshape the tongue to match this target during /r/ production.
15888916|NCT03736200|Other|Exergaming group|Neurorehabilitation - 4-week-long intervention, targeted postural instability and mobility using at-limit intensity sensori and visuomotor agility training. (1/day)
15888917|NCT03736200|Other|Physiotherapy|Physiotherapy 4-week-long.
15888918|NCT03736200|Other|Exergaming group 2/day|Neurorehabilitation - 4-week-long intervention, targeted postural instability and mobility using at-limit intensity sensori and visuomotor agility training. (2/day)
15888919|NCT03736187|Drug|Cephalexin|Giving cephalexin and metronidazole in one group &cephalexin alone in another group
15888920|NCT03736161|Drug|Group A- Tofacitinib|Group A patients will receive Tofacitinib 5mg BD. Patients will be followed up at 1, 3 and 6 months. Patients with inadequate response to Tofacitinib 5 mg BD at the end of 3 months will be put on Tofacitinib 10 mg BD. Primary endpoint for efficacy will be determined by ACR 20 response.
15888921|NCT03736161|Drug|Group B- Methotrexate|Group B patients will receive Methotrexate in increasing dose weekly with maximum dose up to 25 mg/week. Patients will be followed up at 1, 3 and 6 months. Patients with inadequate response to highest dose of MTX at the end of 3 months will be put on Tofacitinib 5 mg BD. Primary endpoint for efficacy will be determined by ACR 20 response.
15888922|NCT03736148|Other|Manual Manipulation|Subject was in supine position, and the therapist applied a manual manipulation with right side bending and left rotation of the neck.
15888923|NCT03736148|Other|Instrument-assisted Manipulation|The instrument-assisted manipulation was applied using a handheld Activator IV Adjusting Instrument. Contacts were made firm enough to prevent slipping of the rubber tip but not so firm as to load the spring, in consistence with customary clinical use of the instrument. The spring was then loaded by means of the instrument's trigger mechanism, and the impulse was delivered in an anterosuperior direction, over the posterolateral aspect of the vertebra on the right lamina-pedicle junction of C3.
15888924|NCT03736148|Other|Placebo|Subject was in supine position, and the therapist placed ths subject's cervical with right side bending and left rotation but no manual manipulation was applied.
15888925|NCT03736122|Drug|BSG-001|"BSG-001 is in solution form, 4mg per vial (2mg/mL) with Inhalation as route of administration using nebulizer.
~BSG-001 will be administrated as an approximately 5 - 30 minutes inhalation session daily for 3 cycles (in repeated 28 days cycle)."
15890028|NCT03727061|Drug|Cisplatin|Standard of Care
15888926|NCT03736109|Genetic|Soluble and genetic biomarkers measurements|Insulin-Like Growth Factor-1 and Coll2-1 gene expression will be measured by real time PCR. In addition, syndecan 4, hyaluronic acid, substance P and nitric oxide will be measured in plasma by ELISA
15888927|NCT03736083|Device|Freestyle Libre Blood Glucose Monitor|The intervention arm of this study will begin using the Freestyle Libre glucose monitor within 2 weeks of their diabetes diagnosis
15888928|NCT03736057|Other|Delayed results of pharmacogenomic results|"1:1 randomization schedule for delayed knowledge of pharmacogenomic results to clinician and patient. Results are released to prescriber at <1 week (unblinded) or 12 weeks (blinded). When genomic results are available upon receipt, unblinded clinicians select an FDA-approved drug from the recommended drugs when possible. Blinded prescribers provide the intended prescription when notified of blinded status. At 4 weeks, 1° outcome measures, NPI-Q and side effects ratings are collected. Clinicians make a GO/NO-GO decision for continuation based on those measures. A NO-GO decision is unblinding and an alternative drug may be prescribed. At 12 weeks, 1° outcomes are collected again. Previously blinded clinicians will be unblinded and may decide to continue or revise the treatment plan based on the clinical outcomes and the genetic results. After the 12 week visit, results of the genetic tests will be entered in the EHR. Further clinical follow-up is based on need."
15888929|NCT03736044|Drug|TNF-blockers suspension in patients with rheumatoid arthritis|in patients treated with anti-TNF the intervention consisted in anti-TNF drug withdrawal, after a preliminary careful examination of remission status; a 18 months (at least) follow up was performed.
15888930|NCT03736031|Behavioral|Intervention (Promotora)|If the patient is in the intervention group, the promotora will call the patient in order to invite them to a meeting. Meetings will be arranged by the promotora and the patients. A total of 2 group meetings will be required by all participants and 1 family meeting.
15888931|NCT03736018|Diagnostic Test|CTCA|Computed Tomography Cardiac angiography (CTCA) performed prior to invasive coronary angiogram (ICA).
15888932|NCT03736005|Other|Exposure of significant critical illness|Exposure. Observational study with all patients invited to follow-up clinic for kidney, muscle and functional assessments.
15888933|NCT03735992|Behavioral|Mind-body medicine group program|The group program is mainly based on MBSR. It further integrates elements of the mind-body medicine cancer program of the Benson-Henry Mind/Body Medical Institute at Harvard Medical School which is rooted in psychoneuroendocrinology and focuses on relaxation techniques, exercise, cognitive restructuring, diet, and social support. In addition, naturopathic methods of selfregulation and self-care are incorporated.
15888934|NCT03735979|Drug|Argatroban|Direct Thrombin Inhibitor - Argatroban is a derivative of arginine that competitively binds to the active site of thrombin thereby preventing fibrin deposition. With a half-life of 30 minutes, argatroban has an immediate anticoagulant effect after IV administration which is rapidly reversed with discontinuation of the drug.
15888935|NCT03735979|Drug|Eptifibatide|GP 2b/3a Receptor Inhibitor - The final step of platelet aggregation is mediated via the GP2b/3a receptor. Eptifibatide was specifically developed to ensure rapid inhibition of platelet aggregation (within 15 minutes), a short half-life (~2 hours) and rapid dissociation from platelets with 50% restoration of platelet function within 2-4 hours of discontinuation.
15888936|NCT03735979|Drug|Placebo|IV placebo solution
15888937|NCT03735966|Drug|Pyrotinib plus trastuzumab and docetaxel and carboplatin|pyrotinib: 320mg orally daily，6cycles; trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 6cycles; docetaxel:after the biological window, 100mg/m2 for a total of 6 cycles carboplatin:d1 ，AUC 6 iv 3-weekly for a total of 6 cycles
15888938|NCT03735953|Diagnostic Test|Retroflexion in the total colon|retroflexion in the cecum or proximal ascending colon and slow withdrawal to the rectum
15888939|NCT03735940|Other|Spot monitoring device, excl. Sham|o During the control phase the 'care as usual' regarding delirium screening is studied. During the intervention phase the DeltaScan will be studied as screening method for delirium. o During the intervention phase the DeltaScan will be used on the exact same moments, i.e. same time and same amount of measures per day, as the screening methods used in the 'care as usual'.
15888940|NCT03735927|Other|Spot monitoring device, excl. Sham|During the control phase the 'care as usual' regarding delirium screening is studied. During the intervention phase the DeltaScan will be studied as screening method for delirium. During the intervention phase the DeltaScan will be used on the exact same moments, i.e. same time and same amount of measures per day, as the screening methods used in the 'care as usual'.
15888941|NCT03735914|Other|MRI|Neuralgic patients for which a cryoneurolysis has been indicated, will passed an MRI befor and after the cryoneurolysis to check the presence of the nerve.
15888942|NCT03735901|Drug|IMP Levodopa 100mg/Carbidopa 25mg|"Study treatment will comprise 3 phases:
~Dose escalation phase: On day 1-3, patients will receive IMP solely in the morning; on day 4-6 in the morning and at lunch time;
~full study treatment phase: from day 7 to day 34, 3 times per day (tid).
~Treatment will stop with a tapering phase: On day 35-37, patients will receive IMP in the morning and at lunch time; on day 38 and 39 solely in the morning."
15888943|NCT03735901|Drug|Matching placebo|"Study treatment will comprise 3 phases:
~Dose escalation phase: On day 1-3, patients will receive Placebo solely in the morning; on day 4-6 in the morning and at lunch time;
~full study treatment phase: from day 7 to day 34, Placebo capsules 3 times per day (tid).
~Treatment will stop with a tapering phase: On day 35-37, patients will receive Placebo in the morning and at lunch time; on day 38 and 39 solely in the morning."
15888944|NCT03735875|Drug|Quizartinib|Given PO
15888945|NCT03735875|Drug|Venetoclax|Given PO
15888946|NCT03735862|Biological|Hepatic derived surgical matrix|Hiatal hernia repair with MIROMESH
15888947|NCT03735849|Biological|VRC07-523LS|Administered by intravenous (IV) infusion
15888948|NCT03735836|Other|MAG-EPA/MAG-DHA omega-3 oils|The monoglyceride (MAG) eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are chemically modified fish oils that fall into the Natural Health products category in Canada.
15888949|NCT03735823|Other|No intervention, just collect blood samples and CSF samples|No intervention
15888950|NCT03735810|Drug|LBS-008|LBS-008 oral capsules
15888951|NCT03735810|Drug|Placebos|Oral capsules
15888952|NCT03735797|Diagnostic Test|Bone marrow aspirate or peripheral blood sample collection|Collection of specimen samples only
15889013|NCT03735316|Drug|Placebos|Placebo is a Normal Saline, 5g, IV, Infused once over 15 minutes. The placebo comes in a 250ml glass vial.
15888953|NCT03735784|Behavioral|AWARE|AWARE consists of four group sessions. The AWARE curriculum involves sharing basic information on sexually transmitted diseases; providing condom use skills training; providing normative feedback on substance use and sexual risk behavior among young adults; discussing unrealistic beliefs about substance use and sexual risk; discussing potential benefits of both cutting down and stopping risky behaviors; and discussing risky situations and coping strategies.
15888954|NCT03735771|Drug|Bupivacaine|0.25% bupivacaine plus fentanyl 8 mcg/ml
15888955|NCT03735758|Drug|pazopanib or guideline conform chemotherapy|Pazopanib (800mg/each day) or guideline conform chemotherapy
15888956|NCT03735745|Other|Blood collection|30cc of blood will be collected.
15888957|NCT03735745|Other|Saliva collection|5cc of saliva will be collected.
15888958|NCT03735745|Other|Tissue collection|Up to 10mg of tissue will be collected.
15888959|NCT03735745|Other|Surveys|The Behavioral Risk Factor Surveillance System (BRFSS), Functional Assessment of Cancer Therapy - Head and Neck module (FACT-HN) the Chicago Priority Scale, Cancer Survivor Unmet Needs surveys will be administered at baseline and 3 months post-surgery.
15888960|NCT03735732|Behavioral|prime|groups be confronted with health or palatability aspects of food items
15888961|NCT03735706|Radiation|Radiation dose reduction|The radiation dose is is different between groups
15888962|NCT03735706|Other|Contrast media volume reduction|Contrast media volume is different between groups
15888963|NCT03735706|Radiation|Unenhanced slice|One unenhanced slice at the level of the portal vein will be added to the protocol before administration of contrast media. It will only take a minute to perform this extra slice. The patient does not have to visit the department a second time and no (extra) contrast is needed for this slice.
15888964|NCT03735706|Diagnostic Test|Weight|A weighing scale is used to measure a patients body weight right before the scan.
15888965|NCT03735693|Diagnostic Test|Ulstrasound|measurement of right femoral cross-section
15888967|NCT03735667|Device|ACURATE neo2™ Transfemoral TAVR System|ACURATE neo2™ Transfemoral TAVR system: Support frame made of nitinol, supra-annular processed tri-leaflet porcine pericardial valve and an outer skirt to limit paravalvular regurgitation (manufactured by Boston Scientific Corporation, Marlborough, MA, USA).
15888968|NCT03735667|Device|Medtronic CoreValve TAVR System|Medtronic CoreValve Evolut R or Evolut PRO Transcatheter Aortic Valve Replacement (TAVR) System (or any future Corevalve iterations): The support frame is manufactured from nitinol, which has multilevel, self-expanding properties and is radiopaque. The bioprosthesis is manufactured by suturing valve leaflets and a skirt from porcine pericardium into a tri-leaflet configuration (manufactured by Medtronic CoreValve LLC, Santa Ana, USA).
15888969|NCT03735667|Device|Edwards SAPIEN 3 TAVR System|Edwards SAPIEN 3 TAVR system (or any future SAPIEN iterations): balloon-expandable transcatheter aortic bioprosthesis, support frame made of cobalt-chromium, three leaflets constructed of processed bovine pericardial tissue and an outer polyethylene terephthalate (PET) sealing cuff to mitigate paravalvular regurgitation (manufactured by Edwards Lifesciences, Inc., Irvine, California, USA)
15888970|NCT03735641|Procedure|Expanded Pedicled Deltopectoral Flap|Expanded Pedicled Deltopectoral Flap is a type of surgical flap
15888971|NCT03735628|Drug|Copanlisib|Copanlisib: lyophilisate for reconstitution and further dilution for infusion
15888972|NCT03735628|Drug|Nivolumab|Nivolumab: concentrate for solution for infusion
15888973|NCT03735615|Behavioral|sprint interval training|Each training session will be performed 3 times per week for 3 weeks. Each session consists of 3-5x20 sec all-out cycling efforts against a load corresponding to 0.05-0.07 kg/kg body mass, separated by 3-5 min of low intensity cycling (20-50 W), on a lode bicycle ergometer (Excalibur Sport V2.0, Groningen, the Netherlands). All training sessions includes a 5 min warm-up and 3 min cool-down.
15888974|NCT03735602|Behavioral|perceptual training|orientation discrimination task
15888975|NCT03735589|Biological|Alpha-type-1 Polarized Dendritic Cells|Given ID
15888976|NCT03735589|Biological|Autologous Natural Killer Cell-like CTLs|Given IP
15888977|NCT03735576|Behavioral|Psychotherapy|15-session individually-delivered CBT specific for LLD in comparison with a supportive unspecific intervention (SUI) of the same quantity
15888978|NCT03735576|Diagnostic Test|Questionnaires|There will be a total of four assessments (see primary & secondary endpoints). The first visit of the study will be a screening and baseline (T0) visit. After the baseline assessment, the subjects will be randomized to either of the two treatment arms. Within one week, the first of the successive bi-weekly 50-minute individual face-to-face treatment sessions will be performed by a study therapist. After 7 therapy sessions, the primary and secondary outcomes will be obtained in week 5 (T1) by the blinded rater. This will be followed by the treatment sessions 8 to 15 which will be carried out by the therapist. End-of-treatment primary and secondary outcomes will be obtained in week 10 (T2). The final follow-up assessment (T3) will be performed 6 months after randomization by the blinded rater.
15888979|NCT03735576|Other|Magnetic Resonance Imaging|Underlying mechanisms are examined using neuroimaging. MRI data are acquired at four scanning sites and will be performed at baseline, end-of-treatment and follow-up to obtain a high-resolution structural T1-weighted image, a T2-weighted FLAIR image, a resting state fMRI, and diffusion tensor imaging (DTI) of the subjects' brain.
15888980|NCT03735576|Other|Blood analysis|Blood sampling will be acquired in order to investigate the underlying mechanisms in LLD and the specific effects of psychotherapy. Blood samples are acquired at five sites at baseline (T0), T1, T2 and T3 for genetic and epigenetic analyses, measurement of Amyloid-β, Neurofilament light chain (NFL), Peripheral Blood Mononuclear Cells (PBMCs), Metabolomics, Proteomics and miRNA analyses.
15888981|NCT03735563|Drug|Ketamine|Individuals will receive randomly either ketamine or fentanyl as a premedication
15888982|NCT03735563|Drug|Fentanyl|Individuals will receive randomly either ketamine or fentanyl as a premedication
15888983|NCT03735550|Device|Contact thermographic breast examination device|A class 2a medical device being an active non-invasive multiple-use thermographic contact tester that uses a technology of passive liquid crystal matrices placed in the head of the device that records a thermographic image of breast glands with application of these matrices to the examined organ. The examination is non-invasive.
15888984|NCT03735537|Drug|Teriparatide Pen Injector|
15888985|NCT03735537|Drug|Zoledronic Acid|Any brand or preparation may be used to deliver the required dose of 5mg
15888986|NCT03735524|Other|Exercise|Different exercises will be adopted including: repetition of different movements for ambulation and stair climbing, repetition of crossed patterns of movements for coordination, postural reactions while standing with eyes open and closed and oscillatory boards for balance, strengthening lower limb muscles, and low-intensity and long-duration static stretching of iliopsoas, rectus femoris, hamstrings, triceps surae, and lumbar spinal muscles for muscular flexibility and range of motion. In addition, advanced robotic therapy will be used to standardize rehabilitative treatment and to obtain more objective indexes of motor function. The Lokomat exoskeleton and the Biodex stability system will be used.
15888987|NCT03735498|Other|Psychological Intervention|Promote effective coping and reduce caregiving burden
15888988|NCT03735485|Other|Conventional Physiotherapy|"The conventional physiotherapy program consisted of electrotherapy and exercise approaches. The electrotherapy program consisted of infrared (for 15 minutes, from 70 cm distance), conventional Transcutaneous Electrical Nerve Stimulation (TENS) in an encircled region (for 20 minutes; with 4 electrodes, 100 Hz, 100 msec), and therapeutic Ultrasound (for 3 minutes; 1 megahertz (MHz), power: 1,5 W/cm²).
~A physiotherapist supervised exercise program was performed following the electrotherapy program. Elastic resistive exercises were added at the week three. While, the first set of wand exercises and elastic resistive exercises was performed under supervision, two sets of the showed exercises were given as the home exercise program."
15888989|NCT03735485|Other|Shoulder Mobilization|In shoulder mobilization technique while the shoulder joint was placed in the traction, anterior, posterior, and inferior gliding and circumduction were applied to the humerus for 2-3 minutes. All mobilization applications were performed in painless range of motion (ROM) limits. The degree of traction and gliding were increased as the relaxing obtained in the tissues.
15888990|NCT03735485|Other|Proprioceptive Neuromuscular Facilitation|"In the Proprioceptive Neuromuscular Facilitation (PNF) program participants received PNF exercises with contract-relax technique, in the patterns of flexion-abduction-external rotation, extension-adduction-internal rotation, flexion-adduction-external rotation and extension-abduction-internal rotation along with the verbal and manual facilitation of the physiotherapist."
15888991|NCT03735472|Device|Thoraflex™ Hybrid|"The Thoraflex™ Hybrid device is particularly suited to the treatment of extended lesions of the ascending aorta, the aortic arch and the descending aorta, which constitute a major challenge in cardiovascular surgery.
~It enables, during a single surgical operation, combination of the Frozen Elephant Trunk technique and a 4-branch prosthesis of the aortic arch, thus enhancing the arsenal of the surgeon in the treatment of complex diseases of the aortic arch."
15888992|NCT03735459|Behavioral|Patient reminders and accountability questionnaires|Participants who are assigned to the patient reminder arm will receive text messages 1, 2, and 4 weeks after enrollment. These text messages will encourage participants to adhere to the provided treatment plan, and ask participants to complete questionnaires to assess their adherence to treatment (in-house Adherence Questionnaire) and severity of eczema (PO-SCORAD) for that week.
15888993|NCT03735446|Drug|Prexasertib|Checkpoint kinase 1 (CHK1) inhibitor
15888994|NCT03735446|Drug|Mitoxantrone|Standard chemotherapy (topoisomerase inhibitor)
15888995|NCT03735446|Drug|Etoposide|Standard chemotherapy (topoisomerase II inhibitor)
15888996|NCT03735446|Drug|Cytarabine|Standard chemotherapy (anti-metabolite)
15888997|NCT03735433|Drug|162mg aspirin dose|2 pills of 81mg aspirin
15888998|NCT03735420|Drug|Xanthohumol|The xanthohumol supplement will be administered in a capsule. Participants in the experimental arm will consume the capsule once per day, with the first meal. The intervention will extend for 8 weeks.
15888999|NCT03735420|Drug|Placebo oral capsule|The placebo (vehicle) will be administered in a capsule. Participants in the placebo arm will consume the capsule once per day, with the first meal.
15889000|NCT03735407|Device|C-Scan procedure|"The subjects will be connected to the C-Scan Track and after successful system's activation. The subject will be asked to ingest the C-Scan Capsule with some water, contrast media The subject will be required to ingest daily dose (3 X 15 ml) of contrast media. Capsule procedure is completed upon capsule excretion.
~o Collecting procedure related data: Technical performance in normal daily routine, Segmental transit time,Procedure duration, Number of Bowel movements , Similarity between C-Scan results and colonoscopy Etc,"
15889001|NCT03735394|Diagnostic Test|ultrasonic probe|apply the head of the ultrasonic probe on the keratinized tissue of the most protruded upper and lower central incisor in order to measure tissue thickness.
15889002|NCT03735381|Device|Pedometer watch 'Xiomi mi band2'|"They receive information on the use of the pedometer.
~Carry the pedometer (Xiaomi Mi Band 2 ™) from 12 to 32GW.
~Prescription of benefits of walking in pregnancy:
~Receive information about the goal of steps / day to be reached: 10,000-11,000 steps / day (Only the intervention 2 group).
~Receive information on the adequacy of walking with moderate intensity.
~They will receive messages on the mobile phone remembering the goal to achieve and a notification that the researching staff will proceed to collect the average count of steps / day of the week prior to 20 and 32 gestation weeks (only for the intervention 2 group)."
15889003|NCT03735368|Drug|Dexmedetomidine Injection|Dexmedetomidine Injection 1 μg/kg then 0.5-1 μg/kg/h infusion
15889004|NCT03735368|Drug|Placebo oral capsule|placebo oral capsules
15889005|NCT03735368|Drug|Pregabalin Oral Capsule|150 mg pregabalin Oral Capsule
15889006|NCT03735368|Drug|topical anesthesia|topical anesthesia of the eye by Benoxinate Hydrochloride 0.4% Eye Drops
15889007|NCT03735355|Procedure|Surgery|Surgical resection of fibrostenotic area
15889008|NCT03735355|Procedure|TTS balloon dilation|Dilation of a stricture using TTS balloon
15889009|NCT03735342|Other|Audio Recording|All participants will be provided with a re-playable audio recording of the discharge discussion on a portable electronic device. In addition, participants will have the option to record the discharge discussion on a personally-owned smartphone or receive access to the recording online, via the Open Recording Automated Logging System (ORALS).
15889010|NCT03735329|Device|Diagnostic test of SPO2|The SpO2 accuracy of the test devices will be evaluated over the oxygen saturation range between 70-100%.
15889011|NCT03735316|Drug|Hydroxocobalamin|5g, IV, Infused once over 15 minutes. The drug comes in a 250ml glass vial with 5g of lyophilized hydroxocobalamin to be reconstituted in 200ml of Normal Saline, Dextrose or Lactated Ringers.
15889012|NCT03735316|Procedure|Cardiopulmonary Bypass|Technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the patient's body.
15889016|NCT03735303|Dietary Supplement|VD3 and omega- 3FA group|50000 IU VD3/week for 8 weeks and 300 mg of omega- 3 FA once daily for 8 weeks
15889017|NCT03735303|Other|control group|no intervention was given
15889018|NCT03735290|Biological|ilixadencel|Intra-tumoral injection
15889019|NCT03735290|Drug|Pembrolizumab|Administered intravenously over 30 minutes, every 3 weeks, at a dose of 200 mg
15889020|NCT03735277|Biological|HPC, Cord Blood|HPC, Cord Blood is supplied as a cryopreserved cell suspension in a sealed bag containing a minimum of 5 × 10^8 total nucleated cells with a minimum of 1.25 × 10^6 viable CD34+ cells in a volume of 25 milliliters. The exact precryopreservation nucleated cell content is provided on the container label and accompanying records.
15889021|NCT03735264|Drug|Anlotinib Hydrochloride plus Docetaxel|Anlotinib Hydrochloride (12mg QD PO d1-14, 21 days per cycle) and Docetaxel (75mg/m2 IV d1)
15889022|NCT03735251|Other|Diuretic，Betaloc，antiplatelet drugs|According to international guidelines,we treated patinets who suffered from different disease
15889023|NCT03735238|Other|SMILE Computerized Decision-Aid|SMILE is a computerized decision-aid designed to give lupus patients information about lupus, treatments for lupus available to them, as well as side effects. This will be administered at every lupus clinic session. Every patient will see the SMILE Computerized Decision-Aid at their index baseline clinic visit.
15889024|NCT03735225|Drug|Dasiglucagon|Dasiglucagon injection
15889025|NCT03735225|Drug|Placebo|Placebo for Dasiglucagon injection
15889026|NCT03735212|Behavioral|Enhanced Services|Participants receive enhanced services over a period of 6 months to support substance abuse recovery, referral to treatment, and parenting skills.
15889027|NCT03735199|Device|PCL-TCP scaffold|During the surgery, the scaffold will be shaped by cutting and shaving with a scalpel so as to fit the extraction socket snugly at the crestal half to two-thirds aspect. A collagen membrane will be placed over the scaffold at the crestal aspect of the socket. The periosteum of the buccal flap will then be incised to allow a tension-free primary closure with 4/0 Vicryl® suture.
15889028|NCT03735199|Device|Geistlich Bio-Gide collagen membrane|A collagen membrane will be placed over the crestal aspect of the socket and the periosteum of the buccal flap will be incised to allow a tension-free primary closure with 4/0 Vicryl® suture.
15889029|NCT03735186|Behavioral|Exercise|60 min treadmill exercise performed at 60% of maximum oxygen uptake.
15889030|NCT03735173|Procedure|ReUnion TSA, pegged design|ReUnion total shoulder arthroplasty system, pegged design
15889031|NCT03735173|Procedure|ReUnion TSA, keeled design|ReUnion total shoulder arthroplasty system, keeled design
15889032|NCT03735160|Device|pressure sensor|Pressure sensor at the angle of intratracheal tube and nasal alar
15889033|NCT03735147|Biological|Live attenuated influenza vaccine (LAIV)|Single dose of LAIV
15889034|NCT03735134|Drug|Colchicine Loading Dose|Two milligrams of colchicine will be administrated in addition to the standard of care treatment
15889035|NCT03735134|Drug|Standard of care treatment prior to elective PCI|All medications normally given to patients prior to elective PCI
15889036|NCT03735121|Drug|Atezolizumab|Atezolizumab will be administered as per the schedule specified in arm or cohort.
15889037|NCT03735121|Drug|rHuPH20|rHuPH20 will be administered as per the scheduled specified in the cohort for Part 1.
15889038|NCT03735095|Drug|Porfimer Sodium|Given IV
15889039|NCT03735095|Procedure|Ultrasound-Guided Transbronchial Needle-Delivered Interstitial Photodynamic Therapy|Undergo EBUS-TBN guided I-PDT
15889040|NCT03735082|Drug|Apatinib|apatinib 250mg,qd,d1-14,14day/cycle
15889041|NCT03735082|Drug|Paclitaxel|paclitaxel 175mg/m2,d1,14day/cycle+carboplatin AUC=4,d1,14day/cycle
15889042|NCT03735082|Drug|Carboplatin|carboplatin AUC=4,d1,14day/cycle;
15889043|NCT03735069|Procedure|IPT (Indirect pulp treatment)|Indirect pulp treatment involves complete caries excavation from the dentin-enamel junction using a round bur. Caries near the pulp is removed with caution using spoon excavator until the remaining dentine shows increased resistance to manual instrumentation. A layer of resin-modified glass ionomer (RMGI) dressing material is placed, followed by resin-modified glass ionomer (RMGI) build-up material, and the final restoration; a preformed Stainless Steel Crown (SSC).
15889044|NCT03735069|Procedure|Cvek/partial pulpotomy|Cvek/partial pulpotomy involves removal of inflamed pulp tissue to depth until healthy pulp tissue is reached (depth of 2-4 mm), as indicated by healthy bleeding and arrest of hemorrhage upon pressure with a cotton pellet moistened with 2.5% NaOCl for 2-5 minutes and repeated for two times if required. Gray MTA will be placed in the pulp chamber in 2-3 mm thickness, moist cotton pellet will be placed to ensure setting and the tooth will be temporized with IRM, the patient will be reviewed after 1 week. If the tooth is asymptomatic, final restoration with RMGIC and stainless steel crown will be placed , and a post-operative radiograph will be taken.
15889045|NCT03735069|Procedure|Cervical pulpotomy|Cervical pulpotomy involves removal of inflamed pulp tissue from all pulp chamber as indicated by healthy bleeding and arrest of hemorrhage upon pressure with a cotton pellet moistened with 2.5% NaOCl for 6 minutes and repeated for two times if required. Gray MTA will be placed in the pulp chamber (2-3mm) thickness, moist cotton pellet will be placed to ensure setting and the tooth will be temporized with IRM, the patient will be reviewed after 1 week. If the tooth is asymptomatic, final restoration with RMGIC and stainless steel crown will be placed , and a post-operative radiograph will be taken.
15889046|NCT03735056|Other|MS Nurse Support|MS Nurse Support intervention is multi-faceted, involving various components (i.e. information provision and emotional support), and a range of strategies and techniques (e.g. psychoeducation, acceptance and commitment), delivered by MS Nurse Specialists, to provide standardised support and advice to patients at diagnosis, to establish and sustain coping strategies. MS Nurse Support intervention is person-centred and tailored to the needs and lifestyle of each participant.
15889047|NCT03735056|Other|Peer Support|Peer Support will be delivered by Peer Support Workers using information provision and supportive listening to provide support and advice to patients at diagnosis, and to provide patients the opportunity to talk freely, extensively and confidentially about their experiences, thoughts and feelings about MS diagnosis and its effects on their lives in a non-judgmental and safe environment. Peer Support intervention is person-centred and tailored to the needs and lifestyle of each participant.
15889080|NCT03734822|Device|Transcutaneous CO2 (TCO2)|Continuous and noninvasive real-time monitoring of transcutaneous CO2.
15889081|NCT03734822|Diagnostic Test|Capillary CO2 (CapCO2)|Capillary CO2 collected by finger stick and run on the i-STAT handheld blood analyzer.
15889048|NCT03735043|Device|cardiac output by ccNexfin ©|Measurement of cardiac output by ccNexfin © comparatively to transthoracic echocardiography Subjects participating to the study will be simultaneously measured for cardiac output by ccNexfin © and transthoracic echocardiography. Echocardiographic measurements of cardiac output will be blinded to values measured by ccNexfin ©. For each participant, a first measurement of cardiac output will be performed in the supine position and then after 1 minute of strict left lateral position.
15889049|NCT03735030|Drug|Human hCG 10'000 IU|A single dose of 10'000 IU of human hCG will be injected in 24 healthy subject volunteers.
15889050|NCT03735030|Drug|Recombinant hCG 6'500 IU|A single dose of 6'500 IU recombinant hCG will be injected in 24 healthy subject volunteers.
15889051|NCT03735017|Other|Non-Interactive Virtual Reality Walking|"Individuals will wear a head-mounted display to allow them to visualize virtual legs in the virtual environment. When wearing the display, individuals will see the legs and arms of their virtual avatar from a first-person perspective.
~Individuals will engage in virtual reality sessions in their home twice daily over the course of 10 days in a two-week period. Each daily session will take approximately 30 minutes, with 5-10 minutes dedicated to the virtual walking experience. Additionally, each daily session will be scheduled a minimum of 4 hours apart."
15889052|NCT03735017|Other|Interactive Virtual Reality Walking|"Individuals will wear a head-mounted display to allow them to visualize virtual legs in the virtual environment. When wearing the display, individuals will see the legs and arms of their virtual avatar from a first-person perspective.
~Individuals will engage in virtual reality sessions in their home twice daily over the course of 10 days in a two-week period. Each daily session will take approximately 30 minutes, with 5-10 minutes dedicated to the virtual walking experience. Additionally, each daily session will be scheduled a minimum of 4 hours apart."
15889053|NCT03735004|Device|Transcranial electrostimulation (TES)|Transcranial electrostimulation (TES) with combined direct (DC) and alternating (AC) current, or TES with DC only will be administered through the skin electrodes positioned on the patient's head
15889054|NCT03734991|Drug|Ibrexafungerp|Ibrexafungerp 300 mg BID for 1 day
15889055|NCT03734991|Drug|Placebo|Matching placebo
15889056|NCT03734978|Diagnostic Test|Diagnosis|biochemistry
15889057|NCT03734965|Device|AWAKEN INTUBATION|Intubation
15889058|NCT03734952|Radiation|Neoadjuvant Radiotherapy Program:|Gross tumor volume (GTV) should include the primary tumor and involved regional lymph nodes as identified on pre-treatment diagnostic studies. Clinical target volume (CTV) is defined as the primary tumor plus 3cm expansion superiorly and inferiorly along the length of the esophagus and a 1cm radial expansion.The nodal CTV should be defined by a 0.5cm expansion from the nodal GTV.CTV should also include coverage the nodal region(s) in which the involved lymph node(s). A total dose of 45 Gy in 25 fractions is delivered 5 days per week on workdays with intensity modulated radiotherapy (IMRT).
15889059|NCT03734952|Drug|Neoadjuvant chemotherapy Program|Chemotherapy is delivered concomitantly and composed of two cycles of paclitaxel 135-200mg per square meter of body-surface area and cisplatin 75mg per square meter of body-surface area every 21 days at the intervals of neoadjuvant radiotherapy.
15889060|NCT03734952|Procedure|Esophagectomy program:|Patients receive esophagectomy in 4-6 weeks after neoadjuvant neoadjuvant chemotherapy
15889061|NCT03734952|Radiation|Postoperative radiotherapy program|A total dose of 18 Gy in10 fractions is delivered 5 days per week on workdays with IMRT.
15889062|NCT03734939|Other|None intervention is planned.|None intervention is planned, just a survey.
15889063|NCT03734926|Drug|ZSP1241|ZSP1241 tablets for oral administration.
15889064|NCT03734913|Drug|ZSP1602|ZSP1602 capsules for oral administration
15889065|NCT03734900|Other|Saline injection|5ml Placebo infusion of 0.9% Sodium Chloride
15889066|NCT03734900|Biological|PRP injection|"Device: Aeon Acti-PRP
~5ml autologous platelet rich plasma injection"
15889067|NCT03734900|Biological|PL injection|"Device: Aeon Acti-PRP
~5ml autologous platelet lysate injection"
15889068|NCT03734887|Behavioral|Social Network Feedback|Social networks are cost-free and highly influential social relationships and interactions that influence behavior and conversely are influenced by a patient's behavior. In addition to receiving a private text message regarding their medication adherence rate, participant's feedback will also be shared to a loved-one or friend that the participant is willing to share medical information with.
15889069|NCT03734887|Behavioral|Private Feedback|Participant will receive medication adherence feedback from a pharmacist at the start of the study.
15889070|NCT03734874|Dietary Supplement|hesperidin|500 mg hesperidin as two capsuls
15889071|NCT03734874|Other|control|no supplementation
15889072|NCT03734861|Device|BreatheSmart System|"BreatheSmart System: a mobile application that tracks medication usage and sends real time reminders
~HeroTracker sensor that counts dosage and monitors real-time medication adherence
~CoheroConnect provider portal that allows the Investigator to monitor adherence"
15889073|NCT03734861|Other|Standard of Care|These patients are reminded to adhere to the prescribed standard of care therapy provided by their clinician during their clinical encounters and when the family calls to report an illness.
15889074|NCT03734848|Drug|Bilateral Ultrasound Guided Pectoralis Nerve Block.|Using a 20-gauge 5 cm needle. Injection bupivacaine 0.25% used as a local anesthetic. The block was performed in a supine position with the arm slightly abducted. The ultrasound probe was placed at the midclavicular level infero-laterally to locate the axillary artery and vein and then moved laterally toward the axilla until pectoralis major, pectoralis minor, and serratus anterior muscles were identified at the level of the fourth rib. The needle was inserted in-plane with respect to the ultrasound probe. A volume of 20 ml of local anesthetic solution was deposited in the fascial plane between pectoralis minor and serratus anterior muscle, followed by withdrawal of the needle to the fascial plane between the pectoralis major and pectoralis minor muscle, where a volume of 10 ml was deposited. The block was performed similarly on the opposite side. Care was taken not to cross the toxic dose of bupivacaine (3 mg/kg).
15889075|NCT03734835|Dietary Supplement|hesperidin|1000 mg hesperidin as two capsules
15889076|NCT03734835|Dietary Supplement|hesperidin and flaxseed|1000 mg hesperidin as two capsules and 30 grams flaxseed
15889077|NCT03734835|Dietary Supplement|flaxseed|30 grams flaxseed
15889078|NCT03734835|Other|control|no supplementation
15889079|NCT03734822|Other|End tidal CO2 (EtCO2)|End tidal CO2 (EtCO2) is monitored through the endotracheal tube during general anesthesia.
15890029|NCT03727061|Drug|Carboplatin|Standard of Care
15889082|NCT03734822|Diagnostic Test|Arterial blood gas (ABG)|Arterial blood gas collected from the radial artery and run on the i-STAT handheld blood analyzer.
15889083|NCT03734809|Drug|Pembrolizumab|200mg every 3 weeks infusion
15889084|NCT03734770|Drug|Subcutaneous Progesterone|Subcutaneous progesterone (Pleyris, IBSA Farmaceutici, Italia) 25 mg one time per day (every day at the same time, according to patient's availability and preference).
15889085|NCT03734770|Drug|Vaginal progesterone|Micronized vaginal progesterone (Progeffik, EFFIK Spa, Italia) 200 mg three times per day (every 8 hours).
15889086|NCT03734757|Procedure|imaging in trimodality|PET-CT and MRI
15889087|NCT03734744|Dietary Supplement|Vitamin D3|Vitamin D is a fat-soluble vitamin that plays an important role in immune modulation in addition to its classical roles in regulation of calcium homeostasis and bone health
15889088|NCT03734731|Device|Monochromatic Infrared Photo Energy (MIRE)|Apply Monochromatic Infrared Photo Energy (MIRE) to the affected nerve
15889089|NCT03734731|Device|Transcutaneous Electrical Nerve Stimulation|Apply Transcutaneous Electrical Nerve Stimulation (TENS) to the affected nerve
15889090|NCT03734731|Drug|Opioids|Prescribe Opioids to treat for pain or circulatory disorders, dosage to be determined by Principal Investigator
15889091|NCT03734731|Drug|Cannabis|Prescribe Cannabis to treat for pain or circulatory disorders, dosage to be determined by Principal Investigator. Comparing Opioid results to Cannabis results with objective nerve testing
15889092|NCT03734718|Drug|GIP|Infusion of Glucose-dependent insulinotropic peptide
15889093|NCT03734705|Behavioral|Imaginal Exposure Writing|Imaginal exposure is a psychotherapy strategy that has been studied and shown to be helpful in the improvement of symptoms (e.g., anxiety, worry) for other psychiatric conditions, including excessive worry and obsessive-compulsive disorder symptoms.
15889094|NCT03734705|Other|Neutral Writing|Used in prior research as a control condition for imaginal exposure. Neutral writing will involve writing about what one would do on a day off work or school.
15889095|NCT03734692|Drug|Rintatolimod|200 mg by IP administration over 1-2 hours
15889096|NCT03734692|Drug|Pembrolizumab|200 mg will be administered as a 30 minute IV infusion
15889097|NCT03734692|Drug|Cisplatin|50mg/m^2 solution
15889098|NCT03734679|Device|SurVeil Drug Coated Balloon|Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
15889099|NCT03734666|Behavioral|Mindfulness Based Relapse Prevention - Smoking and Alcohol|Mindfulness Based Relapse Prevention (MBRP) is a treatment for preventing relapse in addictive disorders that integrates mindfulness meditation with standard relapse prevention practices.
15889100|NCT03734666|Behavioral|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) is a form of therapy that aims to help individuals modify problematic emotions, behaviors, and thoughts.
15889101|NCT03734653|Drug|Transdermal Testosterone|Patients will be prescribed 2 packets of testosterone gel 1% containing 50mg per packet to apply transdermally daily.
15889102|NCT03734653|Drug|Standard of Care, Enzalutamide|Patients will take four 40mg capsules of enzalutamide for a total daily dose of 160mg.
15889103|NCT03734640|Other|Low-intensity monitoring strategy|Post-tpa patients will be monitored in a lower intensity with less vital status and neurological assessment
15889104|NCT03734640|Other|Guideline recommended standard monitoring|Post-tpa patients will be monitored in the usual care monitoring environment
15889105|NCT03734627|Drug|Octreotide Acetate|50mcg octreotide acetate by subcutaneous injection 10 minutes prior to a 400kcal mixed meal challenge
15889106|NCT03734627|Drug|Saline Solution|Equivalent volume of 0.9% saline by subcutaneous injection 10 minutes prior to a 400kcal mixed meal challenge
15889107|NCT03734627|Drug|Paracetamol|Paracetamol 1g by mouth consumed with a 400kcal mixed meal challenge
15889108|NCT03734627|Drug|Sulfasalazine|1g sulfasalazine by mouth consumed with a 400kcal mixed meal challenge
15889109|NCT03734627|Diagnostic Test|Duodenal biopsy|Biopsy from the second part of the duodenum taken at routine endoscopic surveillance, undertaken for another clinical indication.
15889110|NCT03734614|Drug|Low dose of aspirin|Low dose of aspirin, 100 mg daily for longer than one year
15889111|NCT03734601|Radiation|Total body irradiation (TBI)|Administer Total body irradiation (TBI) 80 cGy on Day 1 of standard TLI ATG conditioning
15889112|NCT03734601|Drug|Anti-thymocyte globulin (ATG)|Given intravenous (IV), Dose 1.5 mg/kg x 5 days
15889113|NCT03734601|Drug|Tacrolimus|Oral, Dose 0.05 mg/kg twice daily, can be given intravenous (IV)
15889114|NCT03734601|Drug|Mycophenolate mofetil (MMF)|Given Oral, 15 mg/k every 2 hours for peripheral blood stem cells (PBSC) from matched related donors; 15 mg/kg every 8 hours for PBSC from unrelated donors (URDs) or mismatched related donors.
15889115|NCT03734601|Radiation|Total lymphoid irradiation (TLI)|9 x 120 cGy over 11 days
15889116|NCT03734588|Genetic|SPK-8016|adeno-associated viral vector
15889117|NCT03734575|Device|ClariCore System|The user will perform a standard trans-perineal biopsy and collect a number of biopsy cores as per standard practice.
15889118|NCT03734562|Procedure|Ablation|Substrate-based radiofrequency catheter ablation
15889119|NCT03734562|Drug|Antiarrhythmic drug|Amiodarone or sotalol therapy
15889120|NCT03734536|Device|REGENETEN™ Bioinductive Implant|The REGENETEN™ Bioinductive Implant is a bioabsorbable device that provides a layer of collagen over injured tendons.
15889121|NCT03734536|Device|Arthroscopic repair of the high-grade (>50%) partialthickness|Surgical treatment of partial-thickness rotator cuff tears using standard techniques.
15889122|NCT03734523|Combination Product|Flourish Vaginal Care System|This is not technically an intervention. All women who enroll in the study will be those who have opted to use the Flourish Vaginal Care System. This system is comprised of a vaginal wash (Balance), an intravaginal moisturizing gel (Restore), and a vaginal probiotic supplement (BiopHresh). Balance will be used daily. Restore will be used every other day. BiopHresh will be used twice a week with Restore. All products will be started after the first visit and continue throughout the 6-month study.
15889123|NCT03734510|Dietary Supplement|Dietary Supplement: hesperidin and flaxseed|2 capsules hesperidin and 30 g flaxseed
15889124|NCT03734510|Dietary Supplement|Dietary Supplement: hesperidin|2 capsules hesperidin
15889125|NCT03734510|Dietary Supplement|Dietary Supplement: flaxseed|30 g flaxseed
15889126|NCT03734510|Other|control|no supplementation
15890030|NCT03727061|Biological|Cetuximab|Standard of Care
15889127|NCT03734497|Other|"Group Carotis FTc 500 ml Ringer's lactate Lafleks®"|"will receive 500 ml Ringer's lactate Lafleks® if the patient is fluid responder"
15889128|NCT03734497|Other|"Group Preloading 10 ml/kg Ringer's lactate Lafleks®"|"will receive 10 ml/kg Ringer's lactate Lafleks® fluid preloading"
15889129|NCT03734497|Other|"Group Control 2 ml/kg Ringer's lactate Lafleks®"|"will receive 2 ml/kg Ringer's lactate Lafleks® during anesthesia"
15889130|NCT03734484|Diagnostic Test|InSight|The InSight algorithm which draws information from a patient's electronic health record (EHR) to predict the onset of severe sepsis, and in this study will be customized to differentiate between various Gram-type infections.
15889131|NCT03734471|Device|Reactor Device|The Reactor is a Class II FDA medical device to facilitate the insertion of chest tubes into the thoracic cavity.
15889132|NCT03734471|Procedure|Tube thoracostomy|Traditional chest tube placement
15889133|NCT03734458|Other|Group A - PRF plus AFG with a CAF|Group A - PRF plus AFG with a CAF will be used surgically to cover the exposed roots.
15889134|NCT03734458|Other|Group B - PRF only with a CAF|Group B - PRF only with a CAF will be used surgically to cover the exposed roots.
15889135|NCT03734458|Other|Group C - CTG with a CAF|Group C - CTG with a CAF will be used surgically to cover the exposed roots.
15889136|NCT03734445|Dietary Supplement|Vitamin Supplement|Subjects will be randomly allocated to a supplementation of vitamin C 1000mg, vitamin D 400 IU and zinc 10 mg or an identical placebo. Subjects and researchers will be blinded to the supplement or placebo in order to guarantee double-blinding
15889137|NCT03734445|Other|Placebo|Subjects will be randomly allocated to a supplementation of an identical placebo. Subjects and researchers will be blinded to the supplement or placebo in order to guarantee double-blinding
15889138|NCT03734432|Device|IGAR-Breast TeleOp|Upon consent, each participant will undergo a teleoperative breast biopsy at their local site using the IGAR-Breast system, while the radiologist operates the system from a remote site.
15889139|NCT03734406|Other|Videoclips|The images contained in the videoclips show the pathophysiological process underlying the two diseases under study, namely deep vein thrombosis and atrial fibrillation.
15889140|NCT03734393|Other|HIVD+/R+|Liver from an HIV-infected deceased donor
15889141|NCT03734380|Behavioral|Laboratory-based gait retraining (LGR)|Subjects in the LGR group will be encouraged to modify the gait pattern (e.g. adjusting foot progression angle, performing medial knee thrust, and/or lateral trunk lean) to lower their KAM to 80% of respective average baseline KAM obtained during normal unmodified gait. Real-time auditory feedback will be delivered using stereo speakers from both sides of the staircase. A middle C (261.6 Hz) tone and a high-pitched C (4186.0 Hz) of equal intensity will be generated at a footfall below and above the targeted 80% value, respectively. They will be advised to maintain their new gait pattern during their daily living after training.
15889142|NCT03734380|Behavioral|Sensor-based gait retraining (SGR)|Subjects in the SGR group will receive training similar to LGR, except the KAM measurement is based solely on inputs from IMUs embedded in the shoes. In addition, the auditory feedback will be delivered through a pair of earphones connected to a smartphone, which has been pre-installed with an app for KAM measurement. They will be advised to maintain their new gait pattern during their daily living after training.
15889143|NCT03734380|Behavioral|Walking exercise control (Ctrl)|Subjects in the Ctrl group will walk on the same instrumented staircase at a self-selected pace without any guidance on gait modification. The training period and training time per session will be identical to the other two groups. They will not be given any instructions for out-of-lab activities.
15889144|NCT03734367|Behavioral|Emotional abilities training program|A randomized controlled trial that evaluates the effectiveness of a program of emotional skills on metabolic control to be assessed through the glycosylated hemoglobin (HbA1c), healthy lifestyle habits and wellbeing in adolescents with type 1, Diabetes Mellitus
15889145|NCT03734354|Drug|Brexpiprazole|Brexpiprazole , single/oral/with fasting
15889146|NCT03734341|Device|EZ START Titration|"The auto CPAP device gradually increases air pressure night-by-night until the preset therapeutic pressure is reached.
~Pressure range: from 5 to 14 cmH2O. Ramp: 4cmH2O, 20 minutes. Mask: nasal (if no contraindication).
~Titration pressure: fixed pressure that reduces rAHI below 10, mask leak below 10% of the session, time session above 4 hours."
15889147|NCT03734341|Device|APAP Titration|"The auto CPAP device continuously adjusts the pressure in real time to the minimum pressure needed to maintain upper airway patency at any moment. Pressure range: 5 to 14 cm H2O. Ramp: 4cmH2O, 20 minutes. Mask: nasal (if no contraindication).
~Titration pressure: visual analysis pressure that reduces rAHI below 10 during 90% of the session, mask leak below 10% of the session, therapeutic session above 4 hours."
15889148|NCT03734328|Procedure|connective tissue graft|"anesthesia of the palatal mucosa
~subepithelial connective tissue graft harvesting
~suturing (5/0 silk suture)"
15889149|NCT03734328|Procedure|connective tissue graft&PRF|"anesthesia of the palatal mucosa subepithelial connective tissue graft harvesting
~-suturing (5/0 silk suture)"
15889150|NCT03734328|Other|connective tissue graft&PRF|"taking blood from patient
~centrifuging blood
~obtain PRF"
15889151|NCT03734315|Device|Ostenil®|Ostenil® is a CE-certified viscoelastic solution for injection into the joint cavity, containing 1.0 % sodium hyaluronate from fermentation.
15889152|NCT03734302|Drug|Brexpiprazole|Brexpiprazole , mutiple dose /oral/empty stomach
15889154|NCT03734276|Other|High intensity activity|Cyclo-ergometer session in high intensity setting
15889155|NCT03734276|Other|control arm|Usual care
15889156|NCT03734263|Drug|sodium phenylbutyrate|Enrolled subjects will receive a four-week period of treatment with sodium phenylbutyrate (oral use)
15889157|NCT03734237|Biological|Egg based influenza vaccines|Participants will be randomly allocated to one of three vaccine types in accordance with standard clinical practices for those in the US military. All vaccines are FDA licensed for use in the United States.
15889158|NCT03734237|Biological|Recombinant influenza vaccines|Participants will be randomly allocated to one of three vaccine types in accordance with standard clinical practices for those in the US military. All vaccines are FDA licensed for use in the United States.
15889159|NCT03734237|Biological|Cell-culture based influenza vaccines|Participants will be randomly allocated to one of three vaccine types in accordance with standard clinical practices for those in the US military. All vaccines are FDA licensed for use in the United States.
15889160|NCT03734224|Procedure|Adhesix mesh|Adhesix mesh
15889161|NCT03734224|Procedure|Progrip mesh|Progrip mesh
15889162|NCT03734211|Drug|Evolocumab|420 mg evolocumab will be administered subcutaneously by giving 3 injections consecutively within 30 minutes using the single-use prefilled autoinjector.
15889163|NCT03734211|Drug|Placebo|Placebo will be administered subcutaneously by giving 3 injections consecutively within 30 minutes using the single-use prefilled autoinjector.
15889164|NCT03734198|Drug|Ibrutinib|Ibrutinib will be given at the fixed dose of 420 mg daily for the duration of treatment.
15889165|NCT03734198|Drug|Daratumumab|Daratumumab will be started 28 days after beginning of ibrutinib and will be administered at the standard dose of 16 mg/kg (divided over two days for the first infusion), then 16 mg/kg for the following infusions, weekly for 2 months, then every other week for 4 months and then once a month until progression or intolerance.
15889166|NCT03734185|Other|Learning and Coping|'Experienced patients' plan, teach and evaluate, in cooperation with health professionals.
15889167|NCT03734172|Diagnostic Test|Sample collection|Specimen collection
15889168|NCT03734159|Drug|Ropivacaine|Injection of 60 ml of ropivacaine 0.25% divided into 4 injections of 15 ml (2 per side, between ribs 2 and 3 and between ribs 4 and 5)
15889169|NCT03734159|Drug|sodium chloride 0.9%|Injection of 60 ml of sodium chloride 0.9% divided into 4 injections of 15 ml (2 per side, between ribs 2 and 3 and between ribs 4 and 5)
15889170|NCT03734146|Behavioral|Aerobic Exercise|180 minutes of moderate-vigorous intensity aerobic exercise per week
15889171|NCT03734146|Behavioral|Resistance Exercise|180 minutes of resistance exercise per week
15889172|NCT03734146|Behavioral|Combined aerobic and resistance exercise|180 minutes of exercise per week with 90 minutes per week coming from moderate-vigorous intensity aerobic exercise and 90 minutes per week coming from resistance exercise
15889173|NCT03734133|Other|Foot insoles|Different foot insoles of different hardness
15889174|NCT03734120|Other|cryopreservation|Samples were frozen with a programmable freezing unit. Each semen sample was divided into two aliquots. One aliquot was plunged into liquid nitrogen and the other was stored in dry-phase nitrogen for 3 or 6 month. Thawing was performed at room temperature
15889176|NCT03734094|Device|Ceramic barrier|The use of a ceramic barrier to induce bone formation during GBR
15889177|NCT03734094|Device|Titanium Mesh|The use of a titanium mesh to induce bone formation during GBR
15889178|NCT03734081|Device|ODC system (type 1 capsule)|ODC (one day capsule) type 1 is ingested by a subject and passes through the gastrointestinal tract. Electrical stimulation is the transferred from the capsule to the surrounding GI tissues. The capsule is excreted from the body through the intestinal tract in a natural manner with bowel movement.
15889179|NCT03734081|Device|ODC system (type 2 capsule)|ODC (one day capsule) type 2 is ingested by a subject and passes through the gastrointestinal tract. Electrical stimulation is the transferred from the capsule to the surrounding GI tissues. The capsule is excreted from the body through the intestinal tract in a natural manner with bowel movement.
15889180|NCT03734068|Device|Chemoembolization Using LifePearl|Chemoembolization Using LifePearl
15889181|NCT03734068|Drug|Doxorubicin|Doxorubicin is loaded to LIfePearl
15889182|NCT03734055|Behavioral|Peer Mentoring|Manualized peer mentorship program designed to provide modeling and reinforcement by peers (mentors) to other African American women with SLE (mentees) to encourage them to engage in activities that promote disease self-management.
15889183|NCT03734055|Behavioral|Social Support Group|Social support controls will participate in a lupus support group created for this project, on the same schedule as peer mentoring sessions.
15889186|NCT03734029|Drug|Trastuzumab deruxtecan (DS-8201a)|DS-8201a is a lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered intravenously
15889187|NCT03734029|Drug|Capecitabine|Administered according to label, as one option for Physician's Choice (determined before randomization)
15889188|NCT03734029|Drug|Eribulin|Administered according to label, as one option for Physician's Choice (determined before randomization)
15889189|NCT03734029|Drug|Gemcitabine|Administered according to label, as one option for Physician's Choice (determined before randomization)
15889190|NCT03734029|Drug|Paclitaxel|Administered according to label, as one option for Physician's Choice (determined before randomization)
15889191|NCT03734029|Drug|Nab-paclitaxel|Administered according to label, as one option for Physician's Choice (determined before randomization)
15889192|NCT03734016|Drug|Zanubrutinib|160 mg orally twice daily
15889193|NCT03734016|Drug|Ibrutinib|Ibrutinib 420 mg orally once daily
15889194|NCT03734003|Device|liquid nitrogen|As an active comparator, for patients with cutaneous warts, liquid nitrogen crytherapy is applied
15889195|NCT03734003|Device|controllable infrared bioeffect system|As an experimental arm, for patients with cutaneous warts
15889197|NCT03733964|Procedure|Manual therapy|Manual therapy - the mobilisation of joint segments L4-L5 and L5-S1 and mobilisation techniques for soft tissues (functional massage of soft tissues and skin relaxation using the methods of stretching).
15889302|NCT03733210|Device|IGP-ELVIS-v4 Macroscopic Specimen Imager|Macroscopic specimen imager manufactured by LI-COR Biosciences
15889198|NCT03733964|Procedure|PNF|The PNF method - the movement patterns of the scapulae and the pelvis were used (anterior and posterior elevations and depression) along with the patterns of upper extremities (e.g. bending, abduction, outward rotation) and lower extremities (e.g. bending, abduction, inward rotation with bending of the knee joint).
15889199|NCT03733964|Procedure|Manual therapy + PNF|Combination therapy - Manual therapy and Proprioceptive Neuromuscular Facilitation
15889200|NCT03733964|Procedure|Kinesiotherapy|Traditional kinesiotherapy in the form of active slow exercises of back muscles, abdominal and gluteal muscles on a mat. The patients participated in a uniform treatment programme consisting of ten exercises. Each of the exercises was performed in a number of 20 repetitions.
15889201|NCT03733951|Drug|KN046|"Phase Ia：Intravenous (IV) infusions, 1,3 and 5 milligrams per kilogram (mg/kg) every 2 weeks.
~Phase Ib：Intravenous (IV) infusions, 1 ,3 or 3, 5 milligrams per kilogram (mg/kg) every 2 weeks, the dose of phase Ib based on the result of phase Ia."
15889202|NCT03733938|Other|endodontic microsurgery|teeth with failed root canal treatment will be treated by endodontic microsurgery
15889204|NCT03733912|Other|Phthalate metabolites measurement|To measure phthalate metabolites of urine and house dust in Pregnancy and Non-pregnancy groups
15889205|NCT03733899|Diagnostic Test|Local Anesthesia|Minims Proxymetacaine hydrochloride Eye Drops
15889206|NCT03733899|Diagnostic Test|Placebo|Sodium Chloride Solution
15889207|NCT03733886|Device|Burst SCS (Abbott Proclaim IPG and single lead Abbott Octrode at level Th9/10)|Burst SCS implies high frequency SCS treatment in intermittent packets with stimulation below detection level. Abbott BurstDR at default setting: Pulse width 1000 microseconds, frequency 500 Hz/40 Hz, continuous stimulation (no cycling). Pulse amplitude at maximum 60% of sensory threshold
15889208|NCT03733873|Drug|Desmopressin|take desmopressin for 3 months
15889209|NCT03733873|Drug|Suoquan|take Suoquan mixture for 3 months
15889210|NCT03733860|Procedure|Cavernous tissue sparing penile prosthesis implantation|Beginning penile prosthesis implantation (Coloplast Titan USA) procedure after intracavenosal injection of PGE1 prostine.
15889211|NCT03733860|Procedure|Conventional penile prosthesis implantation|Beginning penile implant procedure (Coloplast Titan USA) without prior intracavernosal injection of PGE1 prostine
15889212|NCT03733860|Procedure|Intracavernosal injection of alprostadil|Intraoperative intracavernosal injection of alprostadil in the cavernous sparing group
15889213|NCT03733821|Device|Repetitive Transcranial Magnetic Stimulation|Non-invasive brain stimulation tool
15889214|NCT03733808|Device|Repetitive Transcranial Magnetic Stimulation|Non-invasive brain stimulation technique
15889215|NCT03733795|Other|TCD|Transcranial Doppler will be used to measure brain blood flow in the middle cerebral artery.
15889216|NCT03733782|Dietary Supplement|Modular enteral protein - Prosource|Supplemental protein (2 gm/kg/day of Prosource; Medtrition, Lancaster, PA) was administered via the nasal/oral feeding tube in 60 - 180 ml bolus infusions 2 - 4 times per day, independently of the enteral formula received. That is, the daily target amount of protein was initially administered as the supplement boluses and only after the enteral formula infusion approached the target rate was the amount of supplement decreased. Supplemental protein was reduced by 50% once the patient received 75% of targeted caloric intake over the previous day (0700 - 0700). Once the patient reached the target caloric intake for 48 hours, the amount of supplemental protein was decreased in order that the total protein prescribed equaled 2 gm/kg/day.
15889217|NCT03733769|Procedure|transmuscular quadratus lumborum block|transmuscular quadratus lumborum block as an alternative to lumbar plexus block for peri-operative analgesia in hip Surgery
15889218|NCT03733756|Procedure|POEM preserving longitudinal muscle|participants are operated POEM only involving circular muscle, leaving longitudinal muscle intact
15889219|NCT03733756|Procedure|POEM involving longitudinal muscle|participants are operated POEM involving both circular and longitudinal muscle
15889220|NCT03733743|Other|Standardized living protocol|Subjects stay at the research facility for 44 hours and adhere to a standard sleeping, eating and activity protocol. During this protocol, multiple measurements will be performed including skeletal muscle biopsies (m. vastus lateralis), blood draws, indirect calorimetry and MRS measurements.
15889221|NCT03733730|Device|ACRYSOF IQ RESTOR +3.0 Multifocal Toric IOL|Intraocular lens (IOL) intended for visual correction of aphakia in adult patients with and without presbyopia, who desire near, intermediate and distance vision, reduction of residual cylinder and increased spectacle independence. IOLs are implantable medical devices and are intended for long term use over the lifetime of the cataract subject.
15889222|NCT03733730|Device|ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOL|Intraocular lens (IOL) intended for visual correction of aphakia in adult patients with and without presbyopia, who desire near, intermediate and distance vision, reduction of residual cylinder and increased spectacle independence. IOLs are implantable medical devices and are intended for long term use over the lifetime of the cataract subject.
15889223|NCT03733730|Device|ACRYSOF IQ RESTOR +2.5 D Multifocal IOL|Intraocular lens (IOL) intended for visual correction of aphakia in adult patients with and without presbyopia, who desire near, intermediate and distance vision with increased spectacle independence. IOLs are implantable medical devices and are intended for long term use over the lifetime of the cataract subject.
15889224|NCT03733730|Procedure|Cataract Surgery|Routine small incision cataract surgery with IOL implantation
15889225|NCT03733717|Drug|Isatuximab SAR650984|"Pharmaceutical form: Concentrate for solution
~Route of administration: Intravenous"
15889226|NCT03733704|Diagnostic Test|Heart rate variability analysis|Heart rate variability analysis extracted from ECG during normal and obstructed breathing
15889227|NCT03733691|Drug|Ixazomib|3 mg oral capsule, Days 1, 8 and 15 of 28-day cycles
15889228|NCT03733691|Drug|Lenalidomide|Same dose as in the front-line treatment in the last treatment cycle, taken orally, on days 1-28 of a 28-day cycle.
15889229|NCT03733678|Behavioral|Price discounts for SARCs|SARCs are offered free to the client
15889230|NCT03733678|Behavioral|Price discounts for LARCs|LARCs are offered at lower prices to the client
15889231|NCT03733678|Behavioral|Sequential vs. simultaneous recommendations|Top ranked methods are presented to the client sequentially or simultaneously
15889303|NCT03733210|Device|Vevo 3100 LAZR-X|Photoacoustic ultrasound imaging system manufactured by VisualSonics
15889232|NCT03733665|Other|Patients admitted to hospital|Data is captured in HES for all patient interactions with the NHS (each episode) in England. All patients admitted for heart failure have data captured in the National Heart Failure Audit.
15889233|NCT03733652|Drug|Interferon Alfa 2a|Patents are treated with interferon alfa 2a 180μg hypodermic injection once per week for 48 weeks. Then, interferon alfa 2a will be stopped if there is HBsAg clearance. Else, oral tenofovir 300mg once per day will be used if HBsAg is positive.
15889234|NCT03733639|Drug|Tisseel|Reinforcement of esophagojejunal anastomoses after total gastrectomy with the product.
15889235|NCT03733639|Device|No Tisseel|No reinforcement of esophagojejunal anastomoses after total gastrectomy
15889236|NCT03733626|Combination Product|ViviGen® Cellular Bone Matrix|ViviGen® is manufactured by DePuy Synthes, Inc. (West Chester, Pennsylvania). ViviGen® Cellular Bone Matrix is comprised of cryopreserved viable cortical cancellous bone matrix and demineralized bone. ViviGen® Cellular Bone Matrix is a Human Cells, Tissues, and Cellular and Tissue-based Product (HCT/P) as defined by the U.S. Food and Drug Administration in 21 CFR 1271.3 and will be used with the DePuy Synthes pedicle screw system for fusion.
15889237|NCT03733626|Combination Product|Local Bone Autograft|Patient's own bone harvested during spinal surgery will be used with the DePuy Synthes pedicle screw system to create the fusion.
15889238|NCT03733613|Other|no intervention|no intervention
15889239|NCT03733587|Drug|GX-I7|GX-I7 25mg/ml/vial
15889240|NCT03733587|Drug|Cyclophosphamide|Cyclophosphamide 500mg/vial
15889241|NCT03733574|Drug|LY03005|Drug: LY03005 80 mg, oral tablets, single dose
15889242|NCT03733574|Drug|Pristiq|Drug: Pristiq 50 mg, oral tablets, single dose
15889243|NCT03733561|Drug|LY03003|LY03003 (rotigotine extended release microspheres for intramuscular [IM] injection)
15889244|NCT03733561|Drug|Neupro 4Mg/24Hr Transdermal Patch|neupro patch
15889245|NCT03733548|Behavioral|RELAX|Regulating Emotions Like An eXpert (RELAX) consists of 8 weekly, 90-minute sessions delivered (60 minutes of parents and adolescents meeting separately, 30 minutes of a combined meeting) in a group format. RELAX equips adolescents with emotion regulation and conflict management skills. This program includes a parent involvement component designed to help parents support adolescents' use of these skills. Each week skills will be discussed and practiced in group, and a skills rehearsal homework activity will be assigned. Following the program, an 8-week follow-up review session will be offered. Additionally, a single 60 minute focus group will be held following the review session to solicit parent and adolescent feedback on the intervention.
15889246|NCT03733535|Drug|Benralizumab|Benralizumab is an interleukin-5 receptor alpha-directed cytolytic monoclonal antibody
15889247|NCT03733535|Drug|129 Xenon|1.0 L of 129-Xenon/4-Helium mixture to acquire MRI images
15889248|NCT03733522|Procedure|Rubber dam isolation|Local anesthesia, use of dental clamp and rubber dam, followed by restoration using universal adhesive system and bulkfill composite restoration
15889249|NCT03733522|Procedure|Relative isolation|No local anesthesia, use of cotton rollers and saliva ejector, followed by restoration using universal adhesive system and bulkfill composite restoration
15889250|NCT03733509|Procedure|Intraoperative Block|One shot adductor canal nerve block with 20ml of bupivacaine 0.25% through surgical incision
15889251|NCT03733509|Procedure|Ultrasound Block|One shot adductor canal nerve block with 20ml of bupivacaine 0.25% mid-thigh
15889252|NCT03733509|Procedure|Intraoperative Placebo|One shot adductor canal nerve infusion with 20ml of saline solution through surgical incision
15889253|NCT03733509|Procedure|Ultrasound Placebo|One shot adductor canal nerve infusion with 20ml of saline solution mid-thigh
15889254|NCT03733483|Behavioral|Sleep Deprivation|Participants in this arm will sleep for 8 hours at their habitual time for 1 week outpatient. Food will be provided for the outpatient week by the study. After the outpatient week participants will check into our inpatient Clinical Translational Research Center (CTRC) for a 9 day inpatient stay. During their inpatient stay participants will be sleep restricted to a 5 hour/night sleep opportunity for nights 2-7 of their inpatient stay. Outcome measures include a 24-hour serum draw (urine and blood) which will occur on night 1 (pre) and night 8 (post). Patients will be given a 10 + hour recovery sleep period on night 8 of their inpatient stay.
15889255|NCT03733470|Drug|Sildenafil study group|One dose of 20 mg Sildenafil will be given one hour before CT imaging.
15889256|NCT03733457|Behavioral|Technology-assisted Stepped-care|Step 1 of the intervention includes educational materials related to asthma. Step 2 includes electronic monitoring of adherence and a text messaging intervention personally tailored to the participant. Step 3 includes problem solving telehealth sessions with a trained clinician.
15889257|NCT03733444|Drug|GLPG1690|GLPG1690, film-coated tablets for oral use.
15889258|NCT03733444|Drug|Placebo|Matching placebo, film-coated tablets for oral use.
15889259|NCT03733431|Device|Gammacore device|Transcutaneous stimulation of vagus nerve with the device positioned below the mandibular angle, medial to the sternocleidomastoid muscle and lateral to the larynx.
15889260|NCT03733431|Device|Gammacore sham device|Sham device which does not deliver electrical stimulation, but instead, produces a buzzing sound will be placed along the lateral border of the sternocleidomastoid muscle in order to avoid mechanical stimulation of the vagus nerve in the carotid triangle.
15889261|NCT03733418|Drug|540,000 IU vitamin D3|This intervention was administered as part of VIOLET parent study. A single dose of 540,000 IU vitamin D3 was administered within 2 hours of randomization time.
15889262|NCT03733418|Drug|Placebo|Placebo was administered by the VIOLET parent study. A single, liquid enteral dose of placebo was administered.
15889263|NCT03733405|Behavioral|Postpartum Visit at 6 Weeks|The patient will be scheduled for a routine postpartum visit at the standard time interval. Each postpartum visit will consist of the standard interview and physical examination. The purpose of this visit is for routine postpartum care. If she has a medical complication during delivery, she may be recommended to schedule an additional earlier visit.
15889264|NCT03733405|Behavioral|Postpartum Visit at 2 Weeks|The patient will be scheduled for an earlier postpartum visit in addition to the standard time interval. Each postpartum visit will consist of the standard interview and physical examination. The purpose of this visit is for routine postpartum care. If she has a medical complication during delivery, she may be recommended to schedule an additional earlier visit.
15889304|NCT03733210|Device|Pearl Triology Imaging System|Near-infrared fluorescent and bioluminescent imaging system manufactured by LI-COR Biosciences
15889265|NCT03733392|Device|Advisor HD Grid Mapping Catheter, Sensor Enabled|The Advisor™ HD Grid Mapping Catheter, Sensor Enabled™, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
15889266|NCT03733379|Procedure|Scaling and root planing|SRP will be performed in four to six appointments lasting approximately 1 h each, using manual curettes (Hu-Friedy, Chicago, IL, USA) and ultrasonic device (Cavitron Select SPC, Dentsply professional, York, PA, USA) under local anesthesia. The deep sites will be scaled throughout the first week and treatment of the entire oral cavity will be completed in 14 days.
15889267|NCT03733379|Drug|Metronidazole and Amoxicillin placebos|Amoxicillin and metronidazole placebos thrice a day for 14 days (beginning with the first SRP session).
15889268|NCT03733379|Drug|Metronidazole|Metronidazole 400 mg thrice a day for 14 days (beginning with the first SRP session).
15889269|NCT03733379|Drug|Amoxicillin|Amoxicillin 500 mg thrice a day for 14 days (beginning with the first SRP session).
15889270|NCT03733379|Dietary Supplement|Probiotic|The probiotic contains 2 different strains of Lactobacillus reuteri: L.reuteri DSM 17938 and L. reuteri ATCC PTA 5289 each at a concentration of 1 x 108 CFU per tablet. It will be used 2 times per day by 90 days.
15889271|NCT03733379|Dietary Supplement|Probiotic placebo|The placebo is identical to the active but without L. reuteri. The two Study Products are identical in taste, texture and shape. It will be used 2 times per day by 90 days.
15889272|NCT03733366|Other|Desk surface|The participants will test all 10 desk surfaces and will be randomly allocated to one of the desks each time.
15889273|NCT03733353|Drug|EDP1815|EDP1815 is an orally administered monoclonal microbial
15889274|NCT03733353|Drug|Placebo oral capsule|Placebo
15889275|NCT03733340|Drug|Imipenem|Imipenem: A wide-spectre antibiotic from the carbapenem group Other name: Imipenem-cilastatin
15889276|NCT03733327|Drug|Busulfan (BU)|Busulfan was administered at 3.2 mg/kg/day on days-7 to -4.
15889277|NCT03733327|Drug|Cyclophosphamide (CY)|Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
15889278|NCT03733327|Drug|Etoposide (VP-16)|Etoposide was administered at 15 mg/kg/day on days -3 to -2.
15889279|NCT03733314|Drug|E6011|E6011, infusion, intravenously.
15889280|NCT03733314|Drug|Placebo|Placebo, infusion, intravenously.
15889281|NCT03733301|Drug|Baricitinib|Administered orally.
15889282|NCT03733301|Drug|Topical corticosteroid|Administered as standard-of-care.
15889283|NCT03733301|Drug|Placebo|Administered orally.
15889284|NCT03733288|Behavioral|Education and training sessions|Agents will be invited to attend sessions in intervention week 1, 3, 9, and month 6. Sessions will introduce (week 1) and reinforce (week 3, 9, month 6) the intervention aims, benefits of and ways to move more and sit less, with emphasis on active breaks. Feedback from baseline assessment will be provided and discussed in week 3 (health data) and 9 (activity data) and month 6 (health and activity data from the 12-week assessment). Each session will include discussion of daily standing/walking goals set by the research team, with timers and a goal log provided to participants in week 1 to enable self-monitoring. The Stand Up champions, and their role to encourage daily movement and sitting reduction through modelling and verbal support, will be communicated and reinforced in each session.
15889285|NCT03733288|Behavioral|Support emails|Agents will receive support emails weekly (weeks 1-12) then monthly (months 4-9) across the intervention. Each email includes an infographic that encourages moving more and sitting less at work.
15889286|NCT03733288|Behavioral|Team leader training|Team leaders in the participating organisation will be invited to attend a training session before the intervention starts. The training aims to enhance team leader's capabilities to demonstrate positive movement and sitting behaviours at work and promote call agents to sit less and move more at work. Team leaders will be asked to include the intervention as an agenda item in their weekly team meetings with their call agents and their 1:1 sessions with call agents. Team leaders will be encouraged to incorporate walking into their 1:1 meetings with call agents.
15889287|NCT03733288|Device|Height-adjustable workstation|After baseline, agents in the SLAMM+ arm will have a height-adjustable workstation installed on their existing workplace desk. This will enable work in a seated or standing position, with flexibility to alternate between postures. Desk installation will occur with support from the onsite organisation health and safety team. The research team will brief participants on safe and effective workstation use. A laminated sheet will be fixed to each workstation to remind participants of safe and effective use.
15889288|NCT03733275|Drug|Lidocaine|for experimental arm, lidocaine spray and lidocaine bupivacine mixture-soaked nasal packing vs. for placebo arm, normal saline spray and packing
15889289|NCT03733262|Other|De-prescribing Trial|Validated de-prescribing algorithms will be applied for any patients identified as taking one of the 9 study drugs in order to determine whether or not physician should consider a deprescribing trial. If they are are identified as candidates for deprescribing and consent to participate in the trial, they will enter the Deprescribing Trial group and begin the deprescribing trial.
15889290|NCT03733249|Drug|Rimiducid|Rimiducid is administered to treat chronic graft versus host disease
15889291|NCT03733249|Biological|rivogenlecleucel|donor T-cells modified with iCasp safety switch
15889292|NCT03733236|Device|ISS Active Stimulation|ISS SPG stimulation and standard of care
15889293|NCT03733223|Drug|Ateptidase|Treatment of ischemic stroke with Ateptidase
15889294|NCT03733210|Drug|Panitumumab-IRDye800|30 mg administered intravenously (IV)
15889295|NCT03733210|Drug|Zirconium Zr-89 Panitumumab|0.8 to 1.2 mCi (29 to 45 Mbq) administered intravenously (IV)
15889296|NCT03733210|Device|Pinpoint IR IR9000 flourescence imaging system (FIS)|Handheld fluorescence-imaging endoscope manufactured by Novadaq
15889297|NCT03733210|Device|SPY-PHI IR9000 flourescence imaging system (FIS)|Handheld fluorescence-imaging endoscope manufactured by Novadaq
15889298|NCT03733210|Device|Explorer Air camera|Fluorescence camera manufactured by SurgVision
15889299|NCT03733210|Device|PDE-NEO II camera|Medical infrared camera manufactured by Hamamatsu Photonics KK
15889300|NCT03733210|Device|FIS-00 fluorescence imaging system (FIS)|Fluorescence imaging system (FIS) manufactured by Hamamatsu Photonics KK
15889301|NCT03733210|Device|Da Vinci Firefly Imaging System|Fluorescence-imaging endoscope, mounted or stand-alone, manufactured by Intuitive Surgical Inc
15890031|NCT03727061|Other|Quality of Life Assessment|Ancillary Studies
15889305|NCT03733210|Device|Odyssey CLx Imaging System|Infrared fluorescent imaging system manufactured by LI-COR Biosciences
15889306|NCT03733210|Device|Leica fluorescence microscope|Fluorescence microscope manufactured by Leica
15889307|NCT03733197|Behavioral|Culture Specific|We anticipate the culture-specific arm developed minimally will include two core components: barbers as motivational interviewers, and (2) fecal immunochemical test (FIT) kits distributed by barbers. If we choose this route for the culture-specific arm, preliminary data from our barbers suggest I teach the barbers the MI technique using content that stems from Aim 1 findings. Additional components for this arm may be developed during the APEASE process.
15889308|NCT03733197|Behavioral|Control|the (control) arm will include an informational CRC screening brochure developed by the American Cancer Society74 plus a FIT kit distributed by the barbers.
15889309|NCT03733184|Procedure|Cytoreduction and Heated Intraperitoneal Surgery|Cytoreductive Surgery is a procedure that aims for the complete removal of all visible tumours affecting the protective lining of the abdomen. After the surgical procedure is completed, the surgeon introduces a heated, sterile solution mixed with chemotherapy drugs into the abdominal cavity (the HIPEC).
15889310|NCT03733171|Drug|PLATELET RICH PLASMA|PRP was injected in 1-2 ml by multiple injections into and circumferentially around the ulcer until bleeding stopped using a 25-G retractable, standard sclerotherapy needle
15889311|NCT03733171|Drug|diluted epinephrine|diluted epinephrine was injected in 1-2 ml by multiple injections into and circumferentially around the ulcer until bleeding stopped using a 25-G retractable, standard sclerotherapy needle
15889312|NCT03733171|Device|hemoclips|diluted epinephrine was injected followed by application of hemoclips
15889313|NCT03733158|Device|the standard Bougie stylet for difficult intubation|intubation with the standard Bougie stylet for difficult intubation and endotracheal tube 7.0 internal diameter
15889314|NCT03733158|Device|The new Flexible Tip Bougie catheter|intubation with The new Flexible Tip Bougie catheter and endotracheal tube 7.0 internal diameter
15889315|NCT03733145|Drug|Angiotensin II|Participants in the ACE inhibitors, ARBs, and Other Classes of Antihypertensive Agents who's systolic blood pressure (SBP) is less than 80% of the baseline reading is detected, will have Ang II initiated at 2 ng/kg/min through a peripheral IV. The infusion will be increased at the discretion of the clinical team based on the response of the patient until a SBP within 5% of the baseline SBP.
15889316|NCT03733132|Drug|Metformin Hydrochloride|Metformin treatment of 2500mg for 10 months in the Metformin group
15889317|NCT03733132|Drug|Placebo Oral Tablet|Placebo treatment of identical tablets to metformin group
15889318|NCT03733119|Drug|Akt/ERK Inhibitor ONC201|Given PO
15889319|NCT03733119|Dietary Supplement|Methionine-Restricted Diet|Given PO
15889320|NCT03733106|Diagnostic Test|digital breast tomosynthesis|pseudo three dimension mammography
15889321|NCT03733106|Diagnostic Test|standard two dimension digital mammogram|standard two dimension mammogram
15889324|NCT03733041|Device|rTMS|This group will receive rTMS treatment
15889325|NCT03733041|Device|Sham|This group will receive sham treatment
15889326|NCT03733041|Other|No intervention|This group will receive no intervention
15889327|NCT03733028|Behavioral|Mobile Intervention for Reducing Anger (MIRA)|This is a mobile intervention that uses interpretation bias modification (IBM) techniques to reduce the hostile interpretation bias. Participants will be given a mobile device with the MIRA app and instructed to complete 5 treatment sessions each week for a period of 4 weeks. Each session takes approximately 10 minutes. The app also includes a Nightly Diary to track symptoms, a calendar to program session reminders, and a My Progress feature to track use and performance.
15889328|NCT03733028|Behavioral|Mindfulness Intervention|"This is a mobile intervention that uses the Mindful Breathing and Body Scan exercises from the Mindfulness Coach app. These audio-guided exercises take approximately 10 minutes each. Participants will be given a mobile device with the Mindfulness app and instructed to complete 5 exercises (i.e., Body Scan or Mindful Breathing) each week for a period of 4 weeks. The app also includes a Nightly Diary to track symptoms, a calendar to program reminders, and a My Progress feature to track use and performance."
15889329|NCT03733015|Device|repetitive transcranial magnetic stimulation|Repetitive transcranial Magnetic Stimulation (rTMS) can be used to temporary modify the brain activity.
15889330|NCT03733002|Drug|AngongNiuhuang pill|This group will receive AngongNiuhuang pill 1 pill 1 times/day for 5-day.
15889331|NCT03733002|Drug|Placebo of AngongNiuhuang pill|This group will receive Placebo of AngongNiuhuang pill 1 pill 1 times/day for 5-day.
15889332|NCT03733002|Other|Standard treatment|The other treatments according to guidelines for standard treatment of acute ischemic stroke.
15889333|NCT03732989|Device|Interactive toy prototype|The interactive toy prototype takes the form of a hand-crafted plush toy, which was designed to support in-the-moment calming down strategies. The interaction relies on a number of sensors embedded in the 'creature' that register haptic interactions with the toy. In addition, a small vibration motor is used to indicate the creature's state by mimicking a frantic 'heartbeat'. If the creature is calming down in response to the child's touching of the sensors, the heartbeat slows down and eventually turns into happy purring (cf. paper linked below for more details about the design process).
15889334|NCT03732989|Device|Non-interactive toy prototype|This toy is the same as the interactive one, but with the interactivity features (haptic feedback) turned off so that it looks and feels like a regular, hand-crafted plush toy.
15889335|NCT03732976|Other|Modified ramped position|This position will be achieved using a special pillow. Shoulders will be elevated and neck will be extended to bring the breasts away from the laryngoscopy. The patient will be positioned so that the tip of the last spinous process (C7) will be at the edge of the pillow. The neck will be extended to the most possible range.
15889467|NCT03731923|Diagnostic Test|Biannual ultrasonography|Biannual liver ultrasonography for HCC surveillance, without contrast agent.
15889336|NCT03732976|Other|Ramped position|This position will be achieved by elevation of the shoulders and the head elevation till achieving alignment of sternal notch and external auditory meatus
15889337|NCT03732963|Drug|Placebo (Group P)|Group P: 20 patients will receive a placebo tablet preoperatively.
15889338|NCT03732963|Drug|Melatonin (Group M)|Group M: 20 patients will receive an oral melatonin tablet 10 mg preoperatively.
15889339|NCT03732950|Biological|Pembrolizumab|Given IV
15889340|NCT03732937|Diagnostic Test|Ultrasonography|Ultrasonography with biometry and TCD measurement
15889341|NCT03732924|Diagnostic Test|Zero to Five Automated Oscillometric Office Blood Pressure (AOBP) Measurement|To compare the difference between the daytime ABPM and AOBP with zero or five minutes wait time.
15889342|NCT03732911|Behavioral|Intervention|Participants will receive the following intervention bundle (1) educational materials about child development and developmental monitoring checklists; (2) age and language appropriate picture books; and (3) two tailored text messages per week for a 6-month period.
15889344|NCT03732885|Device|densah burs osseo densification drills|maxillary sinus floor elevation during implant placement using Densah burs
15889345|NCT03732885|Device|Summer's Osteotomes|maxillary sinus floor elevation during implant placement using Summer's Osteotomes
15889346|NCT03732872|Diagnostic Test|Biopsy tissue analysis|biopsy samples for IHC staining and PCR
15889347|NCT03732872|Diagnostic Test|Saliva analysis|Saliva samples for miRNA 21 expression analysis
15889348|NCT03732846|Drug|Anlotinib|Take Anlotinib 12mg once daily for two weeks, stop for one week, the program repeats every 21 days until it can not tolerate, or disease progression
15889349|NCT03732833|Drug|MT10109L|MT10109L will be injected into either the LCL, or both the LCL and GL.
15889350|NCT03732833|Drug|Placebo|Placebo will be injected into either the GL, or both the LCL and GL.
15889351|NCT03732820|Drug|olaparib|300 mg (2 x 150 milligrams (mg) tablets) twice daily
15889352|NCT03732820|Drug|abiraterone acetate|1000 milligrams (mg) once daily
15889353|NCT03732807|Drug|PF-06651600 Induction Dose|Oral tablets taken once daily (QD)
15889354|NCT03732807|Drug|PF-06651600 Maintenance Dose #1|Oral tablets taken QD
15889355|NCT03732807|Drug|PF-06651600 Maintenance Dose #2|Oral tablets taken QD
15889356|NCT03732807|Drug|PF-06651600 Maintenance Dose #3|Oral tablets taken QD
15889357|NCT03732807|Drug|Placebo|Oral tablets taken QD
15889358|NCT03732794|Device|AtriCure CryoICE & AtriClip LAA Exclusion|AtriCure CryoICE system in performing the Cox-Maze III lesion set, in conjunction with LAA exclusion using the AtriClip device.
15889359|NCT03732781|Drug|Radspherin|"Radspherin® suspension consists of degradable calcium carbonate microparticles with the α-emitting radionuclide 224Ra in suspension.
~Radspherin® will be provided in a R10 vial filled with 10 mL suspension of 224Ra adsorbed on 1 g calcium carbonate microparticles. The volume to be administered will contain 0.7-1 g calcium carbonate microparticles with 1-7 MBq 224Ra. 224Ra has a half-life of 3.6 days."
15889360|NCT03732768|Drug|Radspherin|Radspherin® suspension consists of bio-degradable calcium carbonate micro particles with the α-emitting radionuclide 224Ra in suspension. 224Ra has a physical half-life of 3.6 days. The Sponsor will provide Radspherin® in single dose glass vial and the dose for each subject will be prepared at the site.
15889361|NCT03732755|Device|PoNS Treatment|"PoNS Treatment will consist of three stages: an in-clinic training program, a home training program, and an extended home training program. During all stages of the study, subjects will complete three training sessions per day, morning, afternoon and evening, 6 days per week.
~Daily Training Program: The same daily training program will be performed during all stages with the exception of the morning BAT session, which is not performed during stage 2 or 3:
~Morning:
~Warm Up Exercises without the PoNS Balance Training with PoNS Gait Training with PoNS Breathing and Awareness Training (BAT) with PoNS 3- to 4-hour break between morning and afternoon sessions
~Afternoon:
~Balance Training with PoNS Movement Control Training without PoNS Gait Training with PoNS
~Evening:
~Breathing and Awareness Training with PoNS To be performed at home during all stages"
15889362|NCT03732742|Procedure|TOF repair with trans-annular patch VS preservation of PV|One group study
15889363|NCT03732729|Device|massage chair|Patient should use massage chair, twice per day, for 30minutes
15889364|NCT03732716|Diagnostic Test|blood pressure measurement|Intervention: Each patient's supine and standing blood pressure measurements will be recorded
15889365|NCT03732703|Drug|Abemaciclib, dexamethasone, ixazomib, pomalidomide|Patients with relapsed Multiple Myeloma will receive Abemaciclib and Dexamethasone for the first 2 cycles. Abemaciclib, Dexamethasone, Ixazomib and Pomalidomide from cycle 3 forward. Each cycle is 28 days long.
15889366|NCT03732703|Drug|Enasidenib, dexamethasone, ixazomib, pomalidomide|Patients with relapsed Multiple Myeloma will receive Enasidenib and Dexamethasone for the first 2 cycles. Enasidenib, Dexamethasone, Ixazomib and Pomalidomide from cycle 3 forward. Each cycle is 28 days long.
15889367|NCT03732703|Drug|Cobimetinib, dexamethasone, ixazomib, pomalidomide|Patients with relapsed Multiple Myeloma will receive Cobimetinib and Dexamethasone for the first 2 cycles. Cobimetinib, Dexamethasone, Ixazomib and Pomalidomide from cycle 3 forward. Each cycle is 28 days long.
15889368|NCT03732703|Drug|Erdafitinib, dexamethasone, ixazomib, pomalidomide|Patients with relapsed Multiple Myeloma will receive Erdafitinib and Dexamethasone for the first 2 cycles. Erdafitinib, Dexamethasone, Ixazomib and Pomalidomide from cycle 3 forward. Each cycle is 28 days long.
15889369|NCT03732703|Drug|Venetoclax, dexamethasone, ixazomib, pomalidomide|Patients with t(11;14) translocation will be enrolled in arm E1 and randomized to the venetoclax or the IPd control arm. Patients with relapsed Multiple Myeloma will receive Venetoclax, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.
15889370|NCT03732703|Drug|Daratumumab, dexamethasone, ixazomib, pomalidomide|Patients with relapsed Multiple Myeloma will receive Daratumumab, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.
15889371|NCT03732703|Drug|Belantamab mafodotin, dexamethasone, ixazomib, pomalidomide|Patients with relapsed Multiple Myeloma will receive Belantamab mafodotin, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.
15889372|NCT03732703|Drug|Selinexor, dexamethasone, ixazomib, pomalidomide|Patients with relapsed Multiple Myeloma will receive Selinexor, Ixazomib, Pomalidomide and Dexamethasone every cycle. Each cycle is 28 days long.
15889373|NCT03732690|Other|Diet HP|"2000kcal for men 1800 kcal for women. Food boxes (HP pre-cooked meals and meat/chicken/fish portions, HP breads and snacks) will be provided to the participants throughout the study reaching 40-50% of their prescribed daily energy intake for 6 days per week. In total 932 kcal are provided through this food boxes (54g of carbohydrate, 101g of protein, 34,6g of fat). The rest of the daily food intake will be guided by a dietician with a list of recommended high protein foods.
~Subjects are required to keep food diaries three days a week and will also have weekly contact with a dietician."
15889374|NCT03732690|Other|Diet LP|2000kcal for men 1800 kcal for women. Food boxes (LP pre-cooked meals, LP breads and snacks) will be provided to the participants throughout the study
15889375|NCT03732677|Drug|Durvalumab|Anti- PD-L1 Antibody
15889376|NCT03732677|Drug|Cisplatin|Chemotherapy Agent
15889377|NCT03732677|Drug|Gemcitabine|Chemotherapy agent
15889378|NCT03732664|Drug|Nivolumab, Pembrolizumab|Two to three doses of nivolumab or one to two dose of pembrolizumab will be administered to enrolled patients on Day -42, Day -28, and Day-14 (+/- two days) prior to planned surgery on Day 0 or up to +10 days.
15889379|NCT03732651|Procedure|alteration of PaCO2 level|step changes between 30, 40 and 50 mmHg
15889380|NCT03732638|Drug|Rimegepant|Randomization Phase: Rimegepant (BHV-3000) 75 mg tablet EOD
15889381|NCT03732638|Drug|Placebo|Randomization Phase: Placebo tablet to match rimegepant tablet EOD
15889382|NCT03732625|Drug|Raltegravir|DTG will be replaced by Raltegravir (RAL) 1200 QD, maintaining the other two drugs that constituted the triple therapy established before the inclusion of the patient in the study.
15889383|NCT03732599|Procedure|Standard Deep Anterior Keratoplasty (S-DALK)|Standard (with the use of a blade) deep anterior lamellar keratoplasty (DALK), which is a partial thickness corneal transplant, which has been shown to be a safe and effective procedure.
15889384|NCT03732599|Procedure|IE-DALK (femtosecond)|Femtosecond deep anterior lamellar keratoplasty (DALK). The femotosecond laser technology allows for the creation of precise and reproducible corneal incisions.
15889385|NCT03732586|Dietary Supplement|Omega 5 fatty acid supplement|Patients will be randomized to receive traditional treatment (prednisone 40 mg per day) plus omega 5 fatty acid ( 2 capsules of 0.64g per day) for 28 days.
15889386|NCT03732586|Other|PLACEBO|Patients will be randomized to receive the traditional treatment (prednisone 40 mg per day) plus placebo (2 capsules of placebo with identical appereance and size like omega 5 supplement) for 28 days.
15889387|NCT03732573|Behavioral|Text messages|Text messages conveying 3 specific behaviour change techniques
15889388|NCT03732560|Other|Non-Interventional|Non-Interventional
15889389|NCT03732547|Drug|PD-1 mAb|Intravenous infusion of PD-1 mAb, 200mg, once a time, every three weeks.
15889390|NCT03732547|Drug|PolyIC|Intramuscular injection of polyIC, 2mg, every other day, for three weeks.
15889391|NCT03732534|Drug|NBI-98854|vesicular monoamine transporter 2 (VMAT2) inhibitor
15889392|NCT03732521|Other|Educational therapy|educational intervention to the caregiver and individualization according to their family and social context
15889393|NCT03732508|Drug|Irinotecan liposome|Irinotecan liposome intravenous infusion will be administered during the first day of treatment.
15889394|NCT03732508|Drug|SHR-1316|SHR-1316 intravenous infusion will be administered during the first day of treatment.
15889395|NCT03732508|Drug|Fluorouracil|Fluorouracil intravenous infusion will be administered during the first day of treatment.
15889396|NCT03732495|Drug|Lenvatinib + Denosumab|"Lenvatinib and Denosumab will be used in the indication of their respective SmPCs.
~Study treatments will be divided in fictitious cycles of 28 days. Lenvatinib and Denosumab will be administered as per investigator's decision, based on the data from their SmPC, at starting doses of 24mg once daily and 120mg once every 4 weeks, respectively. Dose modification guidelines of their respective SmPCs will apply.
~Lenvatinib should be started the day after the inclusion. It will be taken every day at the same time, preferentially in the morning.
~As in routine practice, all patients will be supplemented with daily doses of at least 500mg Calcium and 400IU Vitamin D, unless hypercalcemia is present.
~Patients will be encouraged to maintain good oral hygiene during treatment with Denosumab.
~Study drugs will be continued until a treatment discontinuation criterion is met"
15889397|NCT03732482|Drug|Temozolomide capsules|Temozolomide capsules(Jiangsu tasly diyi pharmaceutical Co.,Ltd) Oral Temozolomide capsules 75mg/m2 begins on day 1 and continues until completion of radiotherapy.
15889398|NCT03732482|Device|radiotherapy|Intensity Modulated Radiation Therapy With Simultaneous Integrated Boost
15889399|NCT03732469|Drug|Acetaminophen|Rectal acetaminophen will be administered to the intervention group at the conclusion of the oocyte retrieval.
15889400|NCT03732469|Drug|Fentanyl|Weight-based IV Fentanyl as a part of the standard anesthesia/analgesia induction protocol at Tampa General Hospital
15889401|NCT03732469|Drug|Propofol|Weight-based IV Propofol as a part of the standard anesthesia/analgesia induction protocol at Tampa General Hospital
15889402|NCT03732456|Procedure|Shoulder surgery and post-op pharmacological treatment|Usual care surgery (shoulder arthroscopy) and post-operative pain management protocol
15889403|NCT03732443|Diagnostic Test|FAM-CAM|Family Confusion Assessment Method
15889404|NCT03732430|Drug|IBI308|A humanized anti-PD-1 monoclonal antibody
15889405|NCT03732417|Other|Secondary prevention of cardiovascular risk factors|Intervention group (n=35) Control group (n=35)
15889406|NCT03732404|Drug|preoperative carbohydrate loading|Patients in the treatment group will receive a carbohydrate beverage (total carbohydrates equal to 12.6g/100 mL: 2.1 g monosaccharide, 10.0 g maltodextrin; 240 mOsm/L) in a dose of 800 mL. Patients will be free to drink the beverage from the evening before the operation and up to 2 hours before the induction of anesthesia
15889407|NCT03732404|Drug|Placebo|The control group will receive plain water with the same volume and timing of treatment.
15889408|NCT03732391|Drug|Pembrolizumab 25 MG(milligram)/ML|Carboplatin AUC6 EV will be given every 3 weeks in combination with Pembrolizumab 200 mg EV every 3 weeks for 6 cycles. Afterwards, the Pembrolizumab will be continued with the same schedule until unacceptable toxicity or disease progression
15889409|NCT03732378|Dietary Supplement|Omega-3 capsule|Daily one capsule of omega-3 (EPA 300mg, and 200mg DHA) were given anti depressent( citalopram, escitalopram, paroxetine 1 tablet at night time)
15889507|NCT03731572|Other|Power Training|Hip abductor-adductor resistance exercises at maximum execution speed
15889410|NCT03732365|Combination Product|Ultrasonic Drug Delivery|A maximum dose of 2 grams cefazolin in a solution of 1 gram/100 mL sterile saline will be injected into the affected area, followed by a 3-minute application of external ultrasound delivered at an acoustic intensity equal to 3 watts/square centimeter of surface area.
15889411|NCT03732365|Drug|Standard of Care Antibiotic Treatment|Antibiotic treatment according to the antibiotic package insert instructions for the particular gram-positive pathogen over a period of no more than 14 days.
15889412|NCT03732352|Other|Fludeoxyglucose F-18|Given IV
15889413|NCT03732352|Drug|Osimertinib|Given PO
15889414|NCT03732352|Procedure|Positron Emission Tomography|Undergo fludeoxyglucose F-18 PET scan
15889415|NCT03732339|Device|GILUPI CellCollector®|Use of GILUPI CellCollector® to detect CTC
15889416|NCT03732326|Procedure|bariatric surgery|Bariatric surgery for enrolled patients who fulfill the including criteria
15889417|NCT03732313|Procedure|Central toenail resection|Using local aneasthesia, resection of central part of toenail with germinal matrix.
15889418|NCT03732313|Procedure|Wedge toenail resection|Using local anaesthesia,we remove lateral part of toenail .
15889419|NCT03732300|Other|ASSIP|Three PSychotherapy Sessions plus after 3/6/9/12 months individualized letters
15889420|NCT03732287|Device|Cooling Anesthesia|Application of cooling anesthesia device prior to intravitreal injection
15889421|NCT03732274|Drug|TEW-7197|TEW-7197 will be administered orally for 5 days per week (5D/W) at the same time in the morning and evening (BID) approximately 12 hours apart. Durvalumab will be administered as a dose of 1500 mg every 4weeks.
15889422|NCT03732261|Other|Exercise and dietary|The 12-week study invention will take place between 6 to 8-weeks postpartum and 18 to 20-weeks postpartum, with a follow-up at one year postpartum. The six-week postpartum time point is to allow for exercise clearance from the participant's obstetrician. The exercise clearance is needed prior to the baseline laboratory measurement. Women will be randomized to an intervention group or minimal care group after all baseline measurements (anthropometrics, cardiovascular fitness test, human milk and blood samples and DXA) at six-weeks postpartum. A random numbers table will be used to stratify by parity and determine groups.
15889423|NCT03732248|Drug|Rapamycin|Immunosuppressive drug
15889424|NCT03732248|Drug|Placebo|Inert drug
15889425|NCT03732235|Device|TACE+ systemic Bevacizumab|PEG embolics
15889426|NCT03732235|Drug|FOLFIRI+Bevacizumab|antiangiogenic factor
15889427|NCT03732235|Device|TACE|PEG embolics
15889428|NCT03732222|Procedure|Stretching the diaphragm muscle|Place the hands on the last costal cartilages and maintain the ascent of the ribs in the expiration.
15889429|NCT03732222|Procedure|Impulse technique in rotation of cervical level 3 and 4|head to double chin position and then placed with neutral flexo-extension until focusing on the level of manipulation, ipsilateral lateral flexion and contralateral rotation approximately 45 degrees.
15889430|NCT03732222|Procedure|Combined technique of diaphragm muscle stretch and cervical rotation impulse technique level 3 and 4|"The same initial position, hand placement and technique guidelines will be used, cited in each of the techniques performed in the intervention 1 group and the intervention 2 group."
15889433|NCT03732183|Behavioral|Podcast SMART-3RP|28 daily podcasts, each 15 minutes.
15889434|NCT03732170|Device|TotalFill® Bioceramic sealer|The participant will be treated with TotalFill® Bioceramic sealer.
15889435|NCT03732170|Device|AH plus® sealer|The participant will be treated with AH plus® sealer.
15889436|NCT03732157|Procedure|outpatient management of parathyroidectomy|The patient is discharged from hospital the same day of the parathyroidectomy intervention instead of conventional management (stay overnight in hospital)
15889437|NCT03732157|Procedure|conventional management of parathyroidectomy|The patient stays overnight in hospital after intervention
15889438|NCT03732144|Behavioral|Connect Staff-based PA intervention|After school program sites receiving the Connect intervention will receive a 16 week program that includes three related components - a staff health promotion initiative that helps staff pursue personally-tailored health goals and involves weekly 'check-ins', a tailored social PA curriculum to implement within the program's enrichment hour at least 3 times per week, and a comprehensive staff training program that provides strategies and tools for improving social connections within the program and guided support for implementing the social PA curriculum. Compared to control ASPs, ASPs receiving the 'Connect' program are expected to show greater improvements from baseline to post- and 6 mo follow-up in PA-related social mechanisms, youth PA, and staff PA.
15889439|NCT03732144|Other|Connect Health Curriculum Control|After school program sites receiving the general ASP health curriculum control will address the prevention of several negative health behaviors (e.g., substance use, stress, etc) and also involve three related components- a comprehensive health program curriculum that includes activities that are interactive and fun and where students will learn about a variety of health behaviors (nutrition, stress reduction, etc.) and life skills through group activities, a staff training program that provides strategies and tools for implementing program curriculum, and on-going support from the Connect staff. This arm will serve as the comparison group to the Connect Staff-based PA intervention
15889440|NCT03732118|Device|Eye-tracker Mobile EBT|Use of the eye-tracker for the diagnosis of minimal HE by studying the characteristics of saccades and anti-saccades during a day hospitalization.
15889441|NCT03732105|Radiation|Radiotherapy|Patients in radiotherapy group will receive Intensity Modulated Radiation Therapy (IMRT) at a dose of 50Gy/25fraction after randomization.
15889442|NCT03732105|Drug|Apatinib|Patients in apatinib group will receive oral apatinib at an initial dose of 500mg daily until recurrence, death,patient withdrawal or unacceptable toxic effects. At the first occurrence of grade 3 or 4 toxicities, apatinib was delayed until recovery to grade 2 or below, and then treatment was resumed with a reduction to 500 mg and 250 mg taken on alternate days. At the second occurrence of grade 3 or 4 toxicities, apatinib was delayed until recovery to grade 2, and then treatment was resumed with a reduction to 250 mg once daily.
15890032|NCT03727061|Drug|Fluorouracil|Standard of Care
15889443|NCT03732105|Drug|Radiotherapy+apatinib|Patients in radiotherapy+apatinib group will receive Intensity Modulated Radiation Therapy (IMRT) at a dose of 50 Gy/25 fraction after randomization and after radiotherapy they will receive oral apatinib at an initial dose of 500mg daily until recurrence, death, patient withdrawal or unacceptable toxic effects. Two dose reductions were permitted for apatinib (500 mg and 250 mg taken on alternate days, and 250 mg once daily). At the first occurrence of grade 3 or 4 toxicities, apatinib was delayed until recovery to grade 2 or below, and then treatment was resumed with a reduction to 500 mg and 250 mg taken on alternate days. At the second occurrence of grade 3 or 4 toxicities, apatinib was delayed until recovery to grade 2, and then treatment was resumed with a reduction to 250 mg once daily.
15889444|NCT03732092|Diagnostic Test|Coma Recovery Scale-Revised|Patients with disorders of consciousness were assessed by Coma Recovery Scale-Revised (CRS-R). In addition, we selected three stimuli: 1) 1-octene-3-ol, 2) pyridine, 3) water. We presented these three stimuli in front of the patients nose for 3 seconds.
15889445|NCT03732079|Diagnostic Test|Ultrasound|Ultrasound to measure the IVC diameter. The IVC diameter will be measured in the inspirium and the expirium, and the collapsibility index will be recorded.
15889446|NCT03732066|Behavioral|Usual Text Messages|Usual text messages four times a week, including cardiovascular knowledge and follow-up reminders, such as risk factors for CHD and typical symptoms of myocardial infarction.
15889447|NCT03732066|Behavioral|Personalized Reminders|"The mHealth tools will provide special interventions according to the patients' medical history. For example, patients with hypertension will receive daily reminders on blood pressure measurement and medication. They will also receive early warning on hypertension with a systolic blood pressure of >180 mmHg or <90 mmHg. Patients who smoke will be required to quit smoking. Every patient will receive a Health Report monthly, which will reflect their drug compliance, blood pressure and so on.
~Drug Reminders: Patients' medication information will be recorded by obtaining pictures of their medication. Patients will be asked to punch time clocks simply in the mHealth tools. If they forget to punch cards, they can punch cards whenever they think of it. If there is no record of medication for 3 days, SMS alerts will be received, and phone calls will be received over 7 days."
15889448|NCT03732066|Behavioral|Interactive Responses|"Auto-Response: After sending personal or discomfort symptom questions, the patients will be provided with an automatic response pushed by the back-end database by crawling the keywords. It is suggested that the answer is just for reference. In case of urgent questions, they will be advised to consult the clinicians.
~The researchers will communicate with the patients every month."
15889449|NCT03732053|Other|GPR Intervention Research group|The research intervention consisted in the reappointment of three GPR therapeutic postures.
15889450|NCT03732040|Other|miswak stick|miswak stick use as preventive hygiene measures
15889451|NCT03732040|Other|Miswak plus tooth brushing and tooth paste|use of miswak stick with tooth brushing and fluoride toothpaste for oral hygiene measures
15889452|NCT03732040|Other|Standard preventive measures (tooth brushing , interdental cleaning and mouth rinse use containing CHX and Fluoride)|use toothbrush with fluoride toothpaste and interdental cleaning by dental flossing and use mouth wash containing chlorohexadine
15889453|NCT03732027|Procedure|Surgical Transversus Abdominis Plane Block|At the end of operation and after hemostasis, 20 ml of 0.25% bupivacaine will be injected intra-abdominally into the Transversus Abdominis plane at the midpoint of the line connecting the crista iliaca and inferior costal margin and at two locations in the lateral abdominal wall at 3-4 cm inferior to the previous midline injection. The same procedure will be repeated on the opposite side using an identical amount of local anesthetic.
15889454|NCT03732027|Procedure|Surgical Rectus Sheath Block|At the end of operation and after hemostasis,20 ml 0.25% bupivacaine will be administered slowly under direct vision after careful aspiration to the rectus sheath space which is present inbetween rectus abdominis muscle and the posterior layer of its sheath at the upper pole of the midline incision by time of closure of the anterior abdominal wall. The procedure will be repeated on the opposite side.
15889455|NCT03732001|Drug|Anlotinib combined Docetaxel|Anlotinib ( 12mg, QD, PO d1-14, 21 days per cycle) and Docetaxel (60mg/m2, IV, d1, 21 days per cycle)
15889456|NCT03732001|Drug|Docetaxel|Docetaxel (75mg/m2, IV, d1, 21 days per cycle)
15889457|NCT03731988|Drug|lidocaine/prilocaine (5%) application|For AFL pre-treatment, lidocaine/prilocaine (5%) cream (EMLA; Astra Pharmaceuticals, LP, Westborough, MA, USA) was applied to the treatment area under occlusion for 30 min
15889458|NCT03731988|Device|2940-nm Er:YAG AFL pretreatment|After the anaesthetic cream was removed, AFL therapy was performed using a 2940-nm Er:YAG AFL (Joule; Sciton Inc., Palo Alto, CA, USA) at 5.5% or 11% or 22% laser density with 350 µm ablation depth, level 1 coagulation and a single pulse
15889459|NCT03731988|Drug|MAL application|Immediately after AFL treatment, an approximately 1- mm-thick layer of MAL (Metvix, PhotoCure ASA, Oslo, Norway) was applied to the lesion and on 5 mm of surrounding normal tissue. Incubation time is 3 hours
15889460|NCT03731988|Other|Measurements of the fluorescence intensity|After 3 hours of application with MAL, saline wash was performed and fluorescence imaging analysis was performed with ultraviolet examination light (model 31602,356 nm; Burton Medical Products Crop.) at 10 cm height above the base of each lesion. The red fluorescence (610 nm-700 nm) was separated and extracted by Matlab program and then used to measure the amount of 633 nm fluorescence of protoporphyrin IX.
15889461|NCT03731988|Device|irradiation with red light-emitting diode lamp|After incubation for 3 hours, the dressing and cream were removed, and the area was cleansed with saline. The area was irradiated with a red light-emitting diode lamp (Aktilite CL 128; PhotoCure ASA, Oslo, Norway) with peak emission at 632 nm, placed 5 cm away from the skin surface, and a total light dose of 37 J/cm-2. All patients wore protective goggles during illumination.
15889462|NCT03731975|Procedure|CTZ Paste|Tooth allocated to this group will be treated with CTZ paste, according to the Cappielo's protocol (1964), updated by Moura et al. (2016).
15889463|NCT03731975|Procedure|GP Paste|Tooth allocated to this group will be treated with Guedes-Pinto paste, according to the Guedes-Pinto's protocol (1981), updated by Mello-Moura et al. (2011).
15889464|NCT03731962|Procedure|Coronary Angiography|All patients received approximately 60 mL of intra arterial iodinated contrast material that was administered via computer-controlled automated power injector at 4 mL per second.
15889465|NCT03731949|Diagnostic Test|Ultrasonography|Ultrasonography to assess placental volume
15889466|NCT03731936|Other|No intervention|No intervention
15898514|NCT03661307|Drug|Decitabine|Given IV
15889468|NCT03731923|Diagnostic Test|Annual abbreviated liver MRI|Abbreviated liver MRI using standard dose of extracellular contrast agent (Dotarem, Guerbet, France) on weight-based dosing. Table time targets 10 minutes.
15889469|NCT03731910|Diagnostic Test|MRI|liver MRI using standard dose of extracellular agent. It includes dynamic contrast-enhanced MRI and diffusion weighted image.
15889470|NCT03731897|Other|5 cc 30% dextrose + 4 cc salin + 1cc 2% lidocaine.|Plantar fascia will be injected to the places where it adheres to the bone.
15889471|NCT03731897|Other|9 cc salin + 1cc 2% lidocaine.|Plantar fascia will be injected to the places where it adheres to the bone.
15889472|NCT03731884|Other|Time from the onset of symptoms to PCI|Patients will be divided in two groups according to the time from the onset of symptoms to PCI
15889473|NCT03731871|Diagnostic Test|Ultrasonography|ultrasound to evaluate parameters of fetal maturity during pregnancy
15889474|NCT03731845|Genetic|Blood sample for genetic test|Patients will be genotyped for single nucleotide polymorphism previously found to be associated with age at natural menopause
15889475|NCT03731845|Biological|Blood sample for hormonal measurement|at each visit : 2x7ml. At the end of the study hormonal measurements (AMH, P4, LH, FSH, E25)
15889476|NCT03731845|Other|Ovarian ultrasound scan|Ovarian ultrasound scan at follow up visits (Y1,Y1.5, Y2.5 Y3.5 Y4.5 Y5.5)
15889477|NCT03731832|Drug|MLN9708|Study drug will be given as a single, oral dose of 4.0 mg weekly (day 1, 8 and 15) for 3 weeks, followed by 1 week without study drug in a 28-day cycle
15889478|NCT03731832|Drug|Pomalidomide 4 MG Oral Capsule|Study drug will be given as an oral dose of 4.0 mg on day 1 until day 21, followed by 1 week without study drug in a 28-day cycle.
15889479|NCT03731832|Drug|Dexamethasone|Dexamethasone will be administered as a single, oral dose of 40 mg/day weekly on day 1, 8, 15 and 22 in patients from 18 to 74 years old. For patients ≥ 75 years old dose has to be reduced to 20 mg/day with the same treatment schedule.
15889480|NCT03731832|Drug|Cyclophosphamide|Cyclophosphamide will be administered once daily as an oral dose of 50 mg on cycle days 1 to 21, followed by one week without drug in a 28-day cycle.
15889481|NCT03731819|Diagnostic Test|Abbreviated PB MRI|Abbreviated PB MRI which targets table time of 10 minutes. For MRI acquisition, standard dose of commercially available MR contrast agent (Gadovist, Bayer, Germany) is used on weight-based dosing (0.1mmol/kg).
15889482|NCT03731793|Biological|Non-Animal Chondroitin Sulphate|Mythocondro® is an ichthyic-like chondroitin sulfate produced by chemical sulfation of a non-sulfated chondroitin backbone obtained by thermo-acid hydrolysis of the capsular polysaccharide naturally produced by an Escherichia coli strain.
15889483|NCT03731793|Other|Placebo|Placebo
15889484|NCT03731780|Other|Personalized Treatment|Targeting individual caries risk factors
15889485|NCT03731780|Other|Chlorhexidine and Remineralization|chlorhexidine mouth wash and remineralizing agent
15889486|NCT03731780|Other|Control|Control is standard preventive measures (tooth brushing, fluoride tooth paste, interdental cleaning)
15889487|NCT03731767|Procedure|Distraction thrust manipulation|Distraction thrust manipulation of the talocural joint in supine position
15889488|NCT03731754|Procedure|Traditional Closure|Primary closure discontinuously the perineal wound of APR
15889489|NCT03731754|Procedure|"Cross closure"|Two triangles of skin in the horizontal direction are excised to enlarge the skin incision, and the tumor resected. Then circumferential subcuticular suture of wound, and with tightening of the circumferential suture, the wound resembles a cross.
15889490|NCT03731741|Drug|Pentoxifylline|a known drug of xanthine derivatives used in intermittent claudication
15889491|NCT03731728|Behavioral|Group CBT|"All therapists will use a manualized Cognitive-Behavior Therapy (CBT) protocol with the same handouts and schedule developed based on the book Mind Over Mood. Group CBT will be provided to a group of maximum 10 participants. Each session will be 2 hours long and will be provided by certified therapists with special training to deliver group CBT. The structure of the session will be agenda setting, check-in, review of homework, new concepts/skills, homework assignment, and feedback."
15889492|NCT03731728|Behavioral|Group exercise|Participants enrolled in the group exercise plus TAU arm of the study will be wait-listed for TAU and will receive 50 minutes of scheduled and facilitated exercises three times a week for 14 weeks.
15889493|NCT03731715|Drug|Carisbamate|An oral liquid formulation (20 mg/mL) of carisbamate (S-carisbamate)
15889494|NCT03731689|Drug|Intrauterine lavage therapy|Intrauterine lavage treatment was performed within 3 to 7 days after the first menstrual period after surgery.
15889495|NCT03731689|Drug|Intrauterine gel-injection therapy|Intrauterine gel-injection treatment was performed within 3 to 7 days after the first menstrual period after surgery.
15889496|NCT03731676|Device|Fixed bearing total knee arthroplasty|Fixed bearing total knee arthroplasty
15889497|NCT03731676|Device|Rotating platform total knee arthroplasty|Rotating platform total knee arthroplasty
15889498|NCT03731663|Behavioral|Exposure to pictures of appetizing food (known as Foodporn)|- Participants allocated to the experimental group will watch a 3 minute video presenting a series of pictures of appetizing foods. An audio of a young adult describing herself eating these foods during a trip to London will be played.
15889499|NCT03731663|Behavioral|Exposure to neutral pictures|Participants allocated to the control group will watch a 3 minute video presenting a series of control pictures of tourist attractions in London. An audio of a young adult describing herself visiting these sites during a trip will be played.
15889500|NCT03731650|Procedure|maxillary sinus lift|non grafted maxillary sinus floor augmentation with simultaneous implant placement
15889501|NCT03731611|Procedure|Umbilical Cord Milking|Umbilical cord milking (UCM) is typically performed by placing the infant below the level of the placenta. The cord is held at 20-25 cm distance from the baby and milked vigorously towards the umbilicus for 3 times at a speed of 10 cm/sec. After completion, the cord is clamped, and the neonate is handed to the resuscitation team.
15889502|NCT03731598|Procedure|bed rest|Volunteers will be physically inactive on bed rest at the clinical research center
15889503|NCT03731585|Behavioral|Behavioral Intervention|Participate in psychological sessions
15889504|NCT03731585|Other|Educational Intervention|Participate in educational sessions
15889505|NCT03731585|Other|Questionnaire Administration|Ancillary studies
15889506|NCT03731585|Procedure|Support Group Therapy|Participate in group sessions
15898515|NCT03661307|Drug|Quizartinib|Given PO
15889508|NCT03731572|Other|Strength Training|Hip abductor-adductor resistance exercises at reduced execution speed
15889509|NCT03731559|Drug|DTG 50 mg OD with food|Dolutegravir 50 mg once daily with food plus 2NRTIs in HIV/TB co-infected patients receiving RIF based anti-TB therapy
15889510|NCT03731559|Drug|DTG 50 mg BID|Dolutegravir 50 mg BID plus 2NRTIs in HIV/TB co-infected patients receiving RIF based anti-TB therapy.
15889511|NCT03731546|Procedure|Delayed cord clamping|Cord clamping 60 seconds after delivery of fetus in preterm infants
15889512|NCT03731533|Behavioral|WellStart|"Five weekly automated text messages linked to an online article on health and wellness.
~Five weekly automated health coach motivational text message to smart phone. Optional back and forth text with their health coach is available.
~Daily Option to participate and post comments or questions in online discussion forum moderated by health coaches.
~Three group (up to 20 participants) health coach online visits (60 minutes).
~Two online group visits with a dietitian in groups of 10-12 participants.
~Three one-on-one online visits with a Physician Advisor to review progress, review any changes in medications by the primary medical provider (PCP), review biometrics and lab results, review safety guidelines and symptoms (30 minutes)."
15889513|NCT03731520|Diagnostic Test|Assessing exercise behavior|11-point Numeric Analogue Scale (NRS) for satisfaction of exercising, Exercise Stages of Change Scale-Short Form (ESCS), Exercise Self-Efficacy Scale (ESES), and Decisional Balance Scale (DBS) for exercise behaviour will be inquired for the patients with JIA.
15889514|NCT03731507|Device|Assessment of Range of Motion with Kinect Controller|A ROM measurement method called as KinectROM by us has been developed with Kinect Controller
15889515|NCT03731494|Biological|Nickel oral hyposensitization treatment|Nickel oral hyposensitization treatment (NiOHT) was performed with hard gelatin capsules containing Nickel sulphate (NiSO4) at different dosages (0.1 ng, 1 ng, 10 ng, 0.1 μg, 0.5 μg) and microcrystalline cellulose as excipient (TIO Nickel, Lofarma SpA, Milan, Italy). Treatment was given 3 times a week increasing progressively the dose from 0.1 ng to 3 μg in 10 weeks with a maintenance phase of 1,5 μg a week for a period of 12 months. After 6 months, patients were allowed to gradually reintroduce nickel-rich foods, starting with those with a maximum of 100 mcg of nickel content. For all the treatment period, information on the appearance of side effects or more severe adverse reactions and the need for antiallergic drugs (corticosteroids, antihistamine drugs) were collected.
15889516|NCT03731481|Behavioral|Lifestyle Medicine|Lifestyle Medicine programs provide instruction in plant-based nutrition, food preparation, methods of stress reduction and incorporation of physical activity into daily routine.
15889517|NCT03731468|Drug|local anesthetic|ultrasound guided superficial cervical block in thyroid surgery
15889518|NCT03731468|Drug|Dexamethasone|dexamethasone will be added to ultrasound guided superficial cervical block in thyroid surgery
15889519|NCT03731455|Device|WISE Cortical Strip|The WISE Cortical Strip is a medical device composed by a strip and by a cable.
15889520|NCT03731442|Radiation|Involved field irradiation|Involved field irradiation; intensity-modulated radiation therapy
15889521|NCT03731442|Radiation|Elective field irradiation|Elective field irradiation; intensity-modulated radiation therapy
15889522|NCT03731442|Drug|Paclitaxel|Paclitaxel 135-150mg/m2, d1, every 3 weeks
15889523|NCT03731442|Drug|Platinum|for lobaplatin, 30mg/m2, d1-2, total dose should not exceed 50mg,every 3 weeks; for nedaplatin 50mg/m2, d1-2, every 3 weeks;
15889524|NCT03731442|Drug|PEG-rhG-CSF|PEG-rhG-CSF 3-6mg, 48 hours after chemotherapy
15889525|NCT03731429|Drug|Lidocaine|prior to extubation
15889526|NCT03731429|Drug|Saline Solution|Prior to extubation
15889527|NCT03731416|Procedure|GBR by xenograft and autogenous bone|Ridge augmentation by native collagen membrane and mix of anorganic bovine bone derived mineral with particulated autogenous bone chips (ratio 1:1).
15889528|NCT03731403|Other|MI varnish|CPP- ACP with 5 % sodium fluoride GC
15889529|NCT03731390|Drug|GR1405 injection|Intravenous administration according to the patient's weight. All dose groups were administered once every 2 weeks.
15889530|NCT03731377|Drug|Crystalloid Solutions|Mini-fluid challenge with crystalloid 250 ml will be given to patients first. After observation of hemodynamic parameters, further fluid challenge will be given for response observation.
15889531|NCT03731364|Drug|CA-008|5 mg in 100 mL 10 mg in 100 mL 15 mg in 100 mL
15889532|NCT03731364|Drug|Placebo|Placebo in 100 mL
15889533|NCT03731351|Procedure|Mechanical Thrombectomy|Acute Ischemic Stroke patient with Large Vessel Occlusion and NIHSS less than or equal to 5 will have a standard of care mechanical thrombectomy. Mechanical thrombectomy is a treatment for stroke that removes clots that block large blood vessels. Some patients may be candidates for this procedure using an angiogram or a catheterization and a device that grabs clots and removes them, to reestablish blood flow to the brain.
15889534|NCT03731325|Behavioral|Episodic Future Thinking Group|"Participants in the Episodic Future Thinking (EFT) Group will train with EFT throughout the entire study. As part of the training, research staff will help participants create cues. Cues are descriptions of future events the participant can vividly imagine as happening right now.
~Participants will be instructed to think about the EFT cues they created to help them focus on the future and importance of reaching their weight-loss goals. Participants will be instructed to use their EFT cues at least once per day, but will be encouraged to use their cues with every eating and physical activity decision."
15889535|NCT03731325|Behavioral|Healthy Thinking Group|"Participants in the Healthy (HT) Group will train with HT throughout the entire study. As part of the training, research staff will help participants create cues. Cues are statements about the nutrition of food and the health benefits of physical activity.
~Participants will be instructed to think about the HT cues they created to help them focus on the future and importance of reaching their weight-loss goals. Participants will be instructed to use their HT cues at least once per day, but will be encouraged to use their cues with every eating and physical activity decision."
15889536|NCT03731312|Other|No intervention|This is an observational study and no interventions will be administered.
15889537|NCT03731286|Dietary Supplement|Alpinia Galanga|2 capsules
15889538|NCT03731286|Dietary Supplement|Alpinia Galanga|2 capsules
15889539|NCT03731286|Dietary Supplement|Microcellulose crystalline|2 capsules
15889598|NCT03730818|Other|Land-based Exercise Group|The intervention will consist of a land-based exercise protocol
15889635|NCT03730532|Other|Cognitive Analytic Therapy Guided Self Help|6-week manualised Cognitive Analytic Therapy Guided Self Help
15889540|NCT03731273|Behavioral|portion size|"Smaller than normal portion size - the intervention is the meal size perceived as 'smaller than normal' that participants are provided with during a lunchtime session in the laboratory.
~'Small-normal' portion size - the intervention is the meal size perceived as 'small normal' that participants are provided with during a lunchtime session in the laboratory.
~'Large normal' portion size - the intervention is the meal size perceived as 'large normal' that participants are provided with during a lunchtime session in the laboratory."
15889543|NCT03731247|Device|OCTAV Patient|In vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient.
15889544|NCT03731247|Device|OCTAV Control group|In vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient.
15889545|NCT03731234|Drug|Ibrutinib|Ibrutinib in combination to rituximab-CHOP followed by ibrutinib maintenance
15889546|NCT03731221|Drug|Bupi HCI and lipo bupi|The local anesthetic (LA) used for the PECS II or serratus plane blocks will be a 0.5% bupivacaine HCL, not to exceed 2.5mg/kg or up to 150mg. The LA solution can be diluted with preservative free normal saline for smaller patients to allow for appropriate volume of injection. Treatment patients will also be given liposomal bupivacaine (EXPAREL, Pacira Pharmaceuticals, Inc. San Diego, CA) in a dose of 266 mg in 20 ml can be safely combined with bupivacaine HCL at a ratio not exceeding 2:1, but cannot be combined with other local anesthetics due to the concern of rapid release of encapsulated bupivacaine and subsequent local anesthetic toxicity.
15889547|NCT03731221|Drug|Bupi HCI|The LA used for the blocks will be a 0.5% bupivacaine HCL, not to exceed 2.5mg/kg or up to 150mg. The LA solution can be diluted with preservative free normal saline for smaller patients to allow for appropriate volume of injection. Control patients will have preservative free normal saline mixed with 0.5% bupivacaine HCL and all patients will have a total block solution volume of 60 ml.
15889548|NCT03731208|Device|Telerehabilitation|"The telerehabilitation program equipment consists of the following devices:
~a tablet with a keyboard and a fingerprint sensor
~two wearable sensors
~a wireless modem
~measuring tape"
15889549|NCT03731182|Biological|V114|V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
15889550|NCT03731182|Biological|Prevnar 13™|Prevnar 13™ pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose
15889551|NCT03731169|Genetic|Voriconazole genotype-specific dosing|"Those in the intervention arm will receive an experimental dosage regimen of voriconazole based on their genetic status.
~URM: 6 mg/kg voriconazole twice on the first day followed by 5 mg/kg twice daily, rounded to the nearest 50mg for oral formulations up to day 4 post-start of voriconazole therapy.
~EM: 6 mg/kg voriconazole twice on the first day followed by 4 mg/kg twice daily, rounded to the nearest 50mg for oral formulations up to day 4 post-start of voriconazole therapy.
~HEM and PM: 6 mg/kg voriconazole twice on the first day followed by 2 mg/kg twice daily, rounded to the nearest 50mg for oral formulations up to day 4 post-start of voriconazole therapy."
15889552|NCT03731169|Drug|Standard of Care|Participants are given 6 mg/kg voriconazole twice on the first day followed by 4 mg/kg twice daily, rounded to the nearest 50mg for oral formulations up to day 4 post-start of voriconazole therapy. After TDM is conducted on day 4 for all patients, dosing in both trial arms will adhere to the following in order to reach the target therapeutic window: 1.0-5.5 mg/L.
15889553|NCT03731143|Procedure|insertion of self retaining bicanalicular stent|"The pigtail probe was passed through the canalicular system from the normal punctum to the occluded aspect. When the tip of the pigtail probe was positioned near the occluded punctal area, the surgeon pushed the area to be tented with the pigtail probe. After they advanced the pigtail probe back and forth several times until they could locate the correct position of the occluded punctum, the authors incised the tented area with a scalpel No. 11 to make a new punctal opening.
~To ensure punctal and canalicular patency, syringing was repeated through the perforated punctum. To prevent re-occlusion of punctal opening, a self retaining bicanalicular tube (FCI®; Paris, France) was inserted through the normal and perforated puncti"
15889554|NCT03731130|Other|EORTC QLQ C30|standardized questionaire
15889555|NCT03731130|Other|EORTC QLQ CR29|standardized questionaire
15889556|NCT03731117|Drug|Furosemide|"Furosemide (FUROSEMIDE®) 20 mg / 2ml, ampoule for injection
~1 mg / kg slow intravenous injection 1.5 mg / kg if chronic exposure to diuretics in the week prior to inclusion Measurement of urine output after two and six hours. Compensation of diuresis by same volume of crystalloids over a 6-hour period"
15889557|NCT03731104|Device|Near InfraRed Spectroscopy assessment|"Regional Cerebral Oxygen saturation (rScO2 ) values will be collected for all patients during the procedure using a 2-wavelength (730-810 nm) cerebral oxymeter (monitor INVOS 5100C®, Medtronics). Two transducers will be placed on both fronto-parietal sides of the patient's head.
~To assess the balance between oxygen delivery and consumption, the Fractional cerebral Tissue Oxygen Extraction (FTOE) will be calculated as this ratio: FTOE=[SpO2-rScO2]/SpO2.
~Data will be collected for a period of 3 hours starting from the beginning of catecholamine treatment."
15889558|NCT03731104|Device|Transcranial Doppler Ultrasound assessment|"Transcranial Doppler ultrasound will be performed for all patients during the procedure using a VIVID S-5 (General Electric®) echograph. All examinations will be performed by a single trained operator. A 3 MHz probe will be placed on left and right temporal window to detect signal from the middle cerebral artery. 2 measures will be performed for each side to have the mean of the two measures; In case of difference in measures of more than 20%, a third measure will be performed.
~Measures will be performed for a period of 3 hours starting from the beginning of catecholamine treatment."
15889592|NCT03730870|Diagnostic Test|Pharmacogenomics report|Intervention is the performance of a pharmacogenomics laboratory-developed test (LDT) performed by high-throughput sequencing of 38 genes involved in drug pharmacokinetics or pharmacodynamics. The clinician reviews the report results for each subject.
15889593|NCT03730857|Drug|Olanzapine|olanzapine tablet
15889594|NCT03730857|Drug|risperidone|risperidone tablet
15889595|NCT03730857|Drug|Paliperidone|paliperidone tablet
15889596|NCT03730831|Behavioral|Narrative Exposure Therapy|8-10 sessions: 1 lifeline session, 6-10 sessions narrative exposure, 1-2 sessions of future-oriented counselling
15889597|NCT03730818|Other|Water-based Exercise Group|The intervention consist will of a water-based exercise protocol
15889559|NCT03731104|Device|Cardiac output assessment|"Transthoracic echocardiography will be realized for all patients during the procedure using a transthoracic ultrasound device (VIVID S-5, General Electric®) with a 3 to 6 MHz probe. All examinations will be performed by a single trained operator.
~Two echocardiographic views will be examined to assess cardiac output : the two-chamber long-axis view to measure sub-aortic diameter (d), and the four-chamber view to measure the Left ventricular outflow tract velocity time integral (LVOT VTI). Cardiac output (Qc) will then be calculated taking account these parameters and heart rate with this formula : Qc = [π x d2 x VTI x HR] / 4 2 measures will be performed to have the mean of the two measures; In case of difference in measures of more than 20%, a third measure will be performed.
~Measures will be performed for a period of 3 hours starting from the beginning of catecholamine treatment."
15889560|NCT03731091|Drug|Calcipotriene/ betamethasone dipropionate topical foam, 0.005%/0.064%|Once daily for 4 weeks (28 days)
15889561|NCT03731091|Drug|Enstilar® foam (LEO Pharma Inc.)|Once daily for 4 weeks (28 days)
15889562|NCT03731091|Other|Placebo of Calcipotriene/ betamethasone dipropionate topical foam|Once daily for 4 weeks (28 days)
15889563|NCT03731078|Other|CBT Informed physical therapy Intervention|The 12 physical therapy sessions delivered in Massachusetts General Hospital outpatient physical therapy sites sessions include:1) evaluation and education; 2) strategy identification and goal setting; 3) functional strengthening part one; 4) functional strengthening part two; 5) pre-gait activities with distraction; 6) gait training with distraction and use of strategies; 7) minimizing tremor with use of strategies; 8) higher level balance training; 9) functional reintegration part one; 10) functional reintegration part two; 11) identification of strategies to limit recurrence; 12) education for relapse prevention.Patients will also be given and asked to complete the self-guided CBT workbookL Overcoming Functional Neurological Symptoms: A Five Area Approach. They will be asked to complete the first two chapters over the first 4 weeks and the remaining 8 chapters over the following 8 weeks.
15889564|NCT03731065|Dietary Supplement|Fructose-maltodextrin|Fructose plus maltodextrin in a ratio of 1:1.4, diluted in water to produce a 16% carbohydrate solution.
15889565|NCT03731065|Dietary Supplement|Fructose-maltodextrin hydrogel|Fructose plus maltodextrin in a ratio of 1:1.4, encapsulated in an alginate-pectin hydrogel diluted in water to produce a 16% carbohydrate solution.
15889566|NCT03731065|Dietary Supplement|Glucose-maltodextrin|Glucose plus maltodextrin in a ratio of 1:1.4, diluted in water to produce a 16% carbohydrate solution.
15889567|NCT03731052|Drug|188-0551 Spray|Topical Spray containing active drug
15889568|NCT03731052|Drug|Vehicle Spray|Topical Spray containing no active drug
15889569|NCT03731039|Other|Observational study|Pain assessment, Anxiety assessment, Depression assessment
15889570|NCT03731026|Combination Product|LightPath® Imaging System and 68Ga-RM2|"Imaging System:The LightPath® Imaging System is an in vitro diagnostic device which has CE mark in Europe, in line with In Vitro Diagnostic Medical Devices 98/79/EC (post-marketing study).
~Radiopharmaceutical: 68Ga-RM2 is an investigational Positron Emission Tomography (PET)/ Computed Tomography (CT) radiopharmaceutical."
15889571|NCT03731026|Drug|68Ga-RM2|Radiopharmaceutical: 68Ga-RM2 is an investigational Positron Emission Tomography (PET)/ Computed Tomography (CT) radiopharmaceutical.
15889572|NCT03731013|Behavioral|Mediterranean diet (MedDiet)|Participants randomized in the Mediterranean diet group without physical activity will be instructed and supported towards adhering to principles of the Mediterranean diet, without changes in physical activity habits.
15889573|NCT03731013|Behavioral|Physical activity (PA)|Participants randomized in the group physical activity without Mediterranean diet will participate in a structured, supervised PA program to achieve 150 min of moderate PA per week, without changes in dietary habits.
15889574|NCT03731013|Behavioral|Mediterranean diet and physical activity|The combination group (MedDiet + PA) will receive the combination of both interventions.
15889575|NCT03731000|Device|PHIL® device|Using PHIL® device for treatment of intracranial dural arteriovenous fistulas
15889579|NCT03730974|Device|Protac Ball BlanketTM (7kg Flexible)|All patients will wear a MotionLogger Micro Watch from Ambulatory Monitoring Inc. NY in all four weeks during all 24hours of the day.
15889580|NCT03730961|Drug|BMS-986231|Intravenous administration
15889581|NCT03730961|Drug|Furosemide|Intravenous administration
15889582|NCT03730961|Drug|Placebo|Intravenous administration
15889583|NCT03730948|Biological|DC vaccine|DC vaccine for colorectal cancer
15889584|NCT03730935|Device|Respiratory muscle endurance training|Respiratory muscle endurance training performed over the duration of 4 weeks
15889585|NCT03730922|Procedure|Delayed-immediate reconstruction|Skin sparing mastectomy and reconstruction with silicone implant or expander covered by pectoral muscle and mesh or matrix. Final reconstruction with any reconstructive procedure 6-12 months after completion of chemotherapy and RT.
15889586|NCT03730922|Procedure|Delayed reconstruction|Total mastectomy and delayed reconstruction:with any reconstructive procedure 6-12 months after completion of PMRT
15889587|NCT03730909|Drug|Sodium Lactate|IV infusion
15889588|NCT03730909|Drug|Sodium chloride|IV infusion
15889589|NCT03730896|Procedure|Dry needling|Dryneedling of the sternocleidomastoid muscles within a standard treatment approach of physical therapy
15889590|NCT03730883|Procedure|Central line removal at 100ml/kg/day.|In this group central line will be removed at the time the infant reaches 100 ml/kg/day of enteral intake if well tolerated.
15889591|NCT03730883|Procedure|Central line removal at 140ml/kg/day.|In this group central line will be removed at the time the infant reaches 140 ml/kg/day of enteral intake if well tolerated.
15898516|NCT03661307|Drug|Venetoclax|Given PO
15889599|NCT03730805|Behavioral|ASSIST-linked Brief Intervention|The intervention follows the WHO's ASSIST-linked Brief Intervention (Humenik et al., 2012; Humeniuk et al., 2010), a manualized one-session intervention that can be categorised as belonging to the Screening and Brief Intervention approach. It follows the FRAMES model (Bien et al., 1993) and contains techniques from Motivational Interviewing (Miller & Rollnick, 1991).
15889600|NCT03730805|Behavioral|Induction of Deliberative Mindset|Based on the Mindset Theory of Action Phases (Gollwitzer & Keller, 2016), a brief writing task (writing down pros and cons for an unresolved personal problem of the participant's own choice) is used to induce a specific psychological state in which the individual is cognitively open to process new information.
15889601|NCT03730805|Behavioral|Induction of Implemental Mindset|Based on the Mindset Theory of Action Phases (Gollwitzer & Keller, 2016), a brief writing task (writing down steps necessary to implement a personal decision of the participant's choice that has not yet been put into practice) is used to induce a specific psychological state in which the individual is cognitively not open to process new information.
15889602|NCT03730792|Behavioral|SHIFT Onboard Intervention|A 12-month onboarding process and social challenge supported with goal setting, computer-based training, self-monitoring, and group motivational interviewing.
15889603|NCT03730779|Drug|Hyperoxia|Patients will receive nocturnal normobaric hyperoxia therapy
15889604|NCT03730766|Drug|Esomeprazole|Proton pump inhibitor
15889605|NCT03730766|Drug|Amoxicillin|Antibiotics for H. pylori eradication
15889606|NCT03730766|Drug|Bismuth Potassium Citrate|Gastric mucosal protective drug with anti-H. pylori effect
15889607|NCT03730753|Device|Programmed intermittent epidural bolus|Programmed intermittent epidural bolus added to patient controlled epidural analgesia
15889608|NCT03730753|Device|Continuous infusion|Continuous infusion added to patient controlled epidural analgesia
15889609|NCT03730740|Drug|Lenalidomide 25mg|Lenalidomide 25mg, day 1 - day 21 (1cycle=28days) for 2yeas
15889610|NCT03730727|Behavioral|Physical activity|Physical activity will consist of either 30-mins of standing still, 30-mins of walking at a self-selected brisk pace on a treadmill, or 3-sets of circuit-exercises (10 squats, 10 push-ups, 10 lunges, 10 sit-ups).
15889611|NCT03730727|Dietary Supplement|Meal|Liquid meal replacement shake containing 500 kcal, with 55% kcals from carb, 30% from fat, and 15% from protein.
15889612|NCT03730714|Drug|"Local Anesthetic, Epinephrine and Morphine"|local anesthesia Bupivacaine 0.5% 20 ml (no more than 2 mg/kg) plus lidocaine 2% 10 ml (no more than 3 mg/kg) mixed together, plus epinephrine 5 mcg/ml (max 150 mcg), combined with morphine 0.1 mg/kg (max10 mg)
15889613|NCT03730714|Drug|"Local Anesthetic, Epinephrine, Morphine and Surgicel"|Surgicel soaked with mixture of: local anesthesia Bupivacaine 0.5% 20 ml (no more than 2 mg/kg) plus lidocaine 2% 10 ml (no more than 3 mg/kg) mixed together, plus epinephrine 5 mcg/ml (max 150 mcg), combined with morphine 0.1 mg/kg (max10 mg)
15889614|NCT03730714|Drug|"Normal Saline"|normal saline 0.9% to soak the surgicel according to the planned technique
15889615|NCT03730701|Behavioral|Prevention program for stroke|The prevention program include individual and group intervention sessions supported by a digital platform. The program will be personally tailored in relation to what the person needs and what to change and the individuals rediness for change. The digital platform will support the person during and in between sessions by prompting goals and goal-fulfilment, logging activities, step counts and provide a forum for sharing and reflection.
15889616|NCT03730688|Device|Conventional compartment pressure measurement|Compartment pressure will be measured using the conventional compartment pressure measurement system.
15889617|NCT03730688|Device|Experimental compartment pressure measurement|Compartment pressure will be measured using the newly-developed compartment pressure measurement system.
15889618|NCT03730675|Procedure|Portal irradiation stent placement|The irradiation portal vein stent was designed as two separate parts that consisted of an outer seeds-loaded-stent and an inner self-expandable metallic stent
15889619|NCT03730675|Procedure|TACE|TACE is a minimally invasive procedure performed in interventional radiology to restrict a tumor's blood supply.
15889620|NCT03730675|Drug|Sorafenib|Sorafenib is a kinase inhibitor drug approved for the treatment of advanced hepatocellular carcinoma.
15889621|NCT03730662|Drug|Tirzepatide|Administered SC.
15889622|NCT03730662|Drug|Insulin Glargine|Administered SC
15889623|NCT03730649|Drug|Sulforaphane (broccoli sprout extract)|Participants will topically apply Sulforaphane for a period of time
15889624|NCT03730649|Radiation|UV or visible light|Participants will have 2 test areas irradiated with up to 5 UV or visible light treatments
15889626|NCT03730623|Behavioral|Supervised exercise training|Supervised exercise training as a conservative management of intermittent claudication in a community setting based on cardiac rehabilitation program
15889627|NCT03730610|Behavioral|Exercise training|Subjects are required to exercise four times a week during six months. Exercise training consists of endurance training, resistance training and high-intensity interval training adjusted to subject's fitness level.
15889628|NCT03730597|Device|reverse shoulder arthroplasty|prosthesis implantation
15889629|NCT03730584|Drug|Ropivacaine|"Ampoules of ROPIVACAINE 2mg / ml will be used by local cutaneous application in soft application with device of hand shower on the painful wounds without exceeding the dose of 1mg / kg per bath."
15889630|NCT03730584|Biological|Blood test|Blood test during the first bath with Ropivacaine for Titration of Ropivacaine
15889631|NCT03730571|Device|AbsorbaSeal 6Fr Vascular Closure Device|Patients whose access site will be closed with the AbsorbaSeal 6Fr Vascular Closure Device
15889632|NCT03730558|Combination Product|aflibercept + FOLFIRI|aflibercept + FOLFIRI
15889633|NCT03730545|Dietary Supplement|enteral immunonutrition|Enteral nutrition was started within 12h at an infusion rate of 20ml per hour for SEN group and 16ml per hour for EIN group in the first 24h. The rates of flow were gradually increasing with 50ml/h in SEN versus 40ml/h in EIN on day 2, 70ml/h versus 56ml/h on day 3 and 100ml/h versus 80ml/h until the 7th day depending on the feeding tolerance.
15889634|NCT03730532|Other|Cognitive Behavioural Therapy Guided Self Help|6-week manualised Cognitive Behavioural Therapy Guided Self Help
15891002|NCT03719443|Biological|VIS649|Single IV dose of study product on Day 1 of study
15889636|NCT03730519|Device|Baroreflex Activation Therapy with Barostim Neo|Baroreflex activation therapy (BAT) delivers electrical field stimulation at the carotid sinus to lower BP.
15889637|NCT03730506|Device|Intra oral scanner|computer guided implant
15889638|NCT03730493|Behavioral|Teaching subjects regarding self-care of PIVC with Pictorial Flashcard.|In the experimental group researcher explained self-care of PIVC using pictorial flashcard on one to one basis. Patients were explained Do's and Don'ts, they have to keep in mind during self-care or management. Doubts of the patients were also addressed simultaneously. After this a copy of pictorial flashcard was given to the subjects to be used in future (during PIVC in-situ). In control group, standard care was given as per the hospital protocol. After 24 hours/one day, PIVC was observed for presence of any complications such as Phlebitis, Infiltration, Pain, Blockage and Dislodgement using V.I.P. Score, Infusion nurses society infiltration scale, Universal pain assessment tool and PIVC Documentation Tool and need for PIVC removal was also assessed. After 72 hours PIVC removed (whatever applicable) site of PIVC was reassessed, reason for removal was recorded and indwelling time was noted.
15889639|NCT03730467|Behavioral|Phone call to the patient|Phone call to the patient
15889640|NCT03730454|Device|Transanastomotic Tube (5FR)|5FR tube left in place for 5 days after completion of esophageal anastomosis.
15889641|NCT03730454|Other|No Transanastomotic Tube|No transanastomotic tube used during repair
15889642|NCT03730441|Device|Colonoscopy|Endoscopic examination of large bowel
15889643|NCT03730415|Procedure|Viscoelastic (VE) Guided Transfusion|A viscoelastic analyzer (ROTEM) will be used to guide the transfusion algorithm during the burn wound excision of subjects enrolled into this arm
15889644|NCT03730402|Drug|Bupivacaine|utilizing local anesthetic to perform a regional block under laparoscopic guidance
15889645|NCT03730402|Drug|Exparel 266 milligram Per 20 ML Injection|utilizing local anesthetic to perform a regional block under laparoscopic guidance
15889646|NCT03730402|Drug|Saline|placebo injection of saline
15889647|NCT03730389|Device|External Physical Vibration Lithecbole (EPVL)|Using the the way of external physical vibration to promote separation of stones from ureteral mucosa and promoting the excretion of ureteral stones
15889648|NCT03730376|Other|Cost Information|participants will be given information on the personal and societal costs
15889649|NCT03730363|Drug|Pentamidine|Pentamidine will be administered as an IV infusion on treatment day 1-3 of a 21-day cycle 3 cycles using 2, 3, and 4 mg/kg dose escalation schedules. Non-investigational agents will be administered as follows: Ifosfamide 5000 mg/m2, Carboplatin 5 area under curve (AUC), and Etoposide 100 mg/mg2.
15889650|NCT03730350|Behavioral|Clinical Hypnosis|Hypnosis guidance and audio tracks aimed at promoting pain relief, reducing distress and anxiety, and facilitating sleep will be provided for independent use, with daily practice recommended. Each hypnosis session will be 20-25 minutes long. The scripts for these sessions have been developed based on the clinical literature (e.g., Elkins, 2014) and are already in use with patients of the pain service.
15889651|NCT03730337|Drug|ONO-7475|ONO-7475 specified dose on specified days
15889652|NCT03730337|Drug|ONO-7475 + ONO-4538|ONO-7475+ONO-4538 specified dose on specified days
15889653|NCT03730324|Diagnostic Test|mpMRI|Study subjects will undergo urine and plasma biomarker testing and mpMRI prior to biopsy
15889654|NCT03730324|Diagnostic Test|Urine and plasma biomarkes.|Study subjects will undergo urine and plasma biomarker testing prior to standard biopsy
15889655|NCT03730311|Drug|Elpida|elsulfavirine, capsules
15889656|NCT03730311|Drug|placebo|placebo
15889657|NCT03730298|Dietary Supplement|American Ginseng|cpr
15889658|NCT03730298|Other|Placebo|cpr
15889659|NCT03730285|Device|Telemedicine|Installation of videotelephone with broadband in patient's home
15889660|NCT03730272|Drug|analgesic drugs and methods|the patient will receive analgesic treatment at the discretion of the physician in charge
15889661|NCT03730259|Other|Web-based Tailored Intervention Preparation for Surgery|A Tailored Internet-based Preparation Program for Perioperative Anxiety and Pain (WebTIPS) is developed using the conceptual framework of the Triple Aim that evaluates the intervention within the context of clinical efficacy, improved child and parent experience, and reduced resource utilization during the surgical episode. WebTIPS aims at reducing perioperative anxiety and pain in children via an internet-based platform with short message service (SMS) two-way communication between a healthcare provider and patient.
15889662|NCT03730246|Procedure|cesarean sectio|consecutive parturients due for cesarean sectio
15889663|NCT03730233|Procedure|Hiatal hernia repair by tension-free mesh closure|
15889664|NCT03730233|Procedure|Hiatal hernia repair by simple suturing|
15889665|NCT03730207|Device|Xpede™ Bone Cement|Xpede™ Bone Cement will be injected into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body by filling the bony trabeculae.
15889666|NCT03730207|Device|Mendec Spine Bone Cement|Mendec Spine Bone Cement will be injected into vertebral body via percutaneous Vertebroplasty or Kyphoplasty to stabilize the fractured vertebral body by filling the bony trabeculae.
15889667|NCT03730194|Dietary Supplement|Melatonin|Melatonin (liquid, immediate release, 3 mg) 30 minutes before bedtime
15889668|NCT03730194|Behavioral|Bedtime Bank|The Bedtime Bank a novel behavioral sleep intervention, which is based upon contingency contracting and relies on a credit or debt-based system to hold adolescents accountable for maintaining a consistent bedtime and improve total sleep time.
15889669|NCT03730181|Drug|Rifapentine|Rifapentine. Initial dose will be 25mg/kg. Based on interim analysis, this may be adjusted throughout the study to achieve target exposures. The standalone water-dispersible rifapentine tablet may be used to adjust the rifapentine doses, if needed.
15889670|NCT03730181|Drug|Isoniazid|Isoniazid. 25mg/kg
15889671|NCT03730168|Other|circuit weight training program|30 male diabetic patients performed circuit weight training for 12 weeks
15889672|NCT03730155|Other|CCT intervention.|8-week course with 2 hours sessions weekly. Participants should meditate 25 min. pr. day during the 8 weeks.
15889673|NCT03730142|Drug|WXFL10030390|WXFL10030390 is a tablet in the form of 0.1mg and 0.5mg, oral, once a day.
15889674|NCT03730129|Drug|Hizentra|Subjects will receive Hizentra 0.4 mg/kg qweekly subcutaneously for 6 months (24 weeks)
15889675|NCT03730116|Drug|bisoprolol/perindopril FDC|the first and only single-pill combination of beta-blocker and ACE inhibitor
15898517|NCT03661294|Diagnostic Test|GE Healthcare Metabolic Oxygenator|
15889676|NCT03730103|Other|Same day discharge|Patients will be discharged home from the hospital on the day of her surgery.
15889677|NCT03730090|Device|zero flux skin termometer|Core temperature is monitored continously, non-invasively
15889678|NCT03730077|Drug|18F-FMISO|18F-FMISO PET/CT
15889679|NCT03730064|Drug|N-acetyl cysteine (NAC)|Experimental medication with N-acetyl cysteine (NAC) for six weeks
15889680|NCT03730051|Drug|Gadoterate meglumine|Participants randomized into this arm will receive gadoterate meglumine contrast for their scheduled breast MRI.
15889681|NCT03730051|Drug|Gadobutrol|Participants randomized into this arm will receive gadobutrol contrast for their scheduled breast MRI.
15889682|NCT03730038|Drug|Treatment of pitavastatin 4 mg qd for 12 weeks|Treatment of pitavastatin 4 mg qd for 12 weeks
15889683|NCT03730038|Behavioral|Life-style modification|Nutritional support with the meal less than 65% of carbohydrate, less than 30% of fat. Exercise 3-4 times, 30 min
15889684|NCT03730025|Other|Auscultation plus NeoTapAS|Pediatric resident responsible for HR assessment will estimate the HR by listening to the praecordium with a stethoscope. When using NeoTapAS, he/she will simultaneously tap the same pace on the screen of an iPad with the NeoTapAS app installed and will verbally communicate the HR displayed on the screen.
15889685|NCT03730025|Other|Auscultation without NeoTapAS|Auscultation without NeoTapAS
15889686|NCT03730012|Drug|gilteritinib|Gilteritinib is administered orally
15889687|NCT03730012|Drug|atezolizumab|Atezolizumab is administered by intravenous infusion
15889688|NCT03729999|Device|Portable, Point-of-Care Ultrasound|Portable ultrasonography done at the bedside.
15889689|NCT03729986|Other|Loaded inspiratory muscle test|Loaded inspiratory muscle tests will be set at 30% of maximal inspiratory pressure in sitting and supine positions. The orders of the two loaded test conditions will be conducted in random order with at least 20 minute separation. This is an observational study. Subjects will perform only 15 breaths with each loaded test condition to exam the performance of their inspiratory muscles. Loaded inspiratory muscle test is not for training.
15889690|NCT03729973|Drug|Ketamine|Patients nebulized ketamine by compressor nebulizing for 15 minutes.
15889691|NCT03729973|Drug|Magnesium Sulfate|Patients nebulized magnesium sulfate 250mg (3ml)plus 2ml normal saline by compressor nebulizing for 15 minutes.
15889692|NCT03729973|Drug|Lidocaine|"In preparation room an I.V line was secured ,and standard monitoring was connected to patient.
~Patients nebulized lidocaine 5ml by compressor nebulizing for 15 minutes."
15889693|NCT03729973|Drug|Normal saline|"In preparation room an I.V line was secured ,and standard monitoring was connected to patient.
~Patients nebulized by compressor nebulizing 5ml normal saline for 15 minutes."
15889694|NCT03729960|Other|LENA recorder|The LENA recorder model# 0121 is a lightweight, pocket-size, rechargeable electronic recorder together with a mobile application to view the data and answer questionnaires
15889695|NCT03729947|Device|Subfascial closed suction drain|Ch 14 closed suction drain
15889696|NCT03729934|Dietary Supplement|Ketone Ester|This arm receives 25 g ketone ester.
15889697|NCT03729934|Dietary Supplement|Ketone Salt|This arm receives 25 g ketone salt.
15889698|NCT03729921|Procedure|gastric variceal ligation|The highest point of the variceal vein was used as the primary ligation site. If the input vein was not obvious, the edge of the variceal vein was ligated. The variceal veins were ligated with a 6-ring ligation device, and more than 18 rings rubber bands could be applied in one session. GVL was performed regularly until varices were obliterated or reduced to residual small varices, which could not be ligated. The residual small varices was treated by cyanoacrylate injection.
15889699|NCT03729921|Procedure|gastric variceal obturation|Gastric varices were uniformly treated via the sandwich technique, which starts with an injection of lauromacrogol, followed by N-butyl cyanoacrylate, then finished with flush of lauromacrogol. The number of injection sites and volume of lauromacrogol and cyanoacrylate used, directly correlated with the size of the varix. Multiple injection sites were chosen in attempt to obliterate the varix or varices in one session. Volume of lauromacrogol used ranged from 2-10ml, while that of cyanoacrylate ranged from 0.5-2ml, per injection site.
15889700|NCT03729908|Behavioral|Animal assisted mindfulness based intervention|A mindfulness based intervention in the presence of an animal
15889701|NCT03729908|Behavioral|Anti-stress program|A mindfulness based intervention with no reference to animals
15889702|NCT03729895|Device|Adjustable Oral Appliance|Adjustable Oral Appliance consist of plastic maxillary occlusal splint，mandible occlusal splint and adjustable connecting rod.It could offer a non-invasive form of treatment but also achieve a good therapeutic effect
15889703|NCT03729882|Procedure|EUS-guided gallbladder drainage|During ERCP evaluation a self-expandable metallic stent will be deployed in the common biliary duct of the patients enrolled in both arms of the present study. A prophylaxis gallbladder drainage will be done using a 3.8 mm working-channel linear-array therapeutic echoendoscope (EG3870UTK;Pentax, Hamburg, Germany) attached to an ultrasound console (Avius Hitachi, Tokyo, Japan) within a transgastric and/or transduodenal approaches to the gallbladder puncture followed by placement of a lumen apposing stent (LAMS) (AXIOS; Xlumena Inc, CA, USA) with a 10 mm luminal diameter and a dumbbell-shaped flanges to bring together the 2 walls in apposition. These feature of the Axios decrease the risk for bile leak, stent migration, and stent occlusion.
15889704|NCT03729882|Procedure|Non EUS-guided gallbladder drainage|During ERCP evaluation a self-expandable metallic stent will be deployed in the common biliary duct of the patients enrolled in both arms of the present study. If the patient had an acute cholecystitis will be sent to surgery and be considered as a Non EUS-guided gallbladder drainage
15889705|NCT03729869|Drug|Progesterone|200 mg of exogenous progesterone twice a day
15889706|NCT03729869|Drug|Placebo|One dose of matched placebo twice a day.
15889707|NCT03729856|Behavioral|intervention|The adapted physical activity (APA) intervention is a theory-based physical activity (PA) promotion intervention. The APA model is comprised of 4 steps: 1) pre-participation evaluation of physiological, personal and environmental factors that influence PA adoption and maintenance; 2) application of individualised, evidence based strategies associated with increased PA participation tailored to the participant's motivational readiness; 3) development of structured exercise and/or lifestyle PA program; and 4) tailored relapse prevention strategies to maintain physical activity beyond the duration of the program. The intervention will be conducted in the participant's home environment.
15890020|NCT03727087|Other|Blood Sample Collection|Subjects participating in the study will have blood drawn at enrollment.
15889708|NCT03729856|Other|B|Participants will undertake their usual activities during the baseline period. An extended pre-intervention time frame is needed to establish a stable control phase and enhance internal validity.
15889709|NCT03729856|Other|Follow-up|Participants will have no contact with intervention personnel during the 5 week follow-up, withdrawal period. The withdrawal phase enables initial assessment of physical activity behavior change.
15889710|NCT03729843|Radiation|CBCT and intraoral digital radiography|Simulated periodontal bone defects will be measured by 2 techniques: group I detected and measured using CBCT and group II intraoral digital radiography and all the measurements will be compared with the gold standard real measurements on the dry jaws
15889711|NCT03729830|Device|Boston Scientific Open Irrigated Ablation Catheters|The BSC Open-Irrigated catheters are designed to deliver RF energy to catheter tip electrode for cardiac ablation. The BSC OI catheters incorporate an open-irrigated cooling mechanism through a tip that is partitioned into two chambers. The proximal chamber circulates normal saline (0.9 %) within the tip to cool the proximal electrode and mitigate overheating while the distal chamber allows the fluid to flow through six irrigation holes into the patient's vasculature, thereby cooling the tip/tissue interface.
15889712|NCT03729817|Device|Submaximal balloon angioplasty|An endovascular procedure involving inflation of a balloon catheter undersized to 50-70% of normal vessel diameter to perform angioplasty of a stenotic blood vessel segment, with the goal of increasing blood flow.
15889713|NCT03729804|Drug|Carfilzomib|"Carfilzomib will be given by IV on Days 1, 2, 15 and 16 of each cycle during cycles 1-8.
~Carfilzomib will be given by IV on days 1, 2, 15 and 16 of each cycle during cycles 9-24."
15889714|NCT03729804|Drug|Lenalidomide|"Lenalidomide will be taken by mouth once a day for days 1-21 of each cycle during cycles 1-8.
~Lenalidomide will be taken by mouth once a day for days 1-21 of each cycle for cycles 9-24."
15889715|NCT03729804|Drug|Dexamethasone|"Dexamethasone will be taken by mouth on days 1, 8, 15 and 22 of each cycle during cycles 1-8.
~Dexamethasone will be taken by mouth on Days 1, 8, 15 and 22 of each cycle during cycles 9-24."
15889716|NCT03729804|Drug|Bortezomib|Bortezomib will be give by IV on days 1, 4, 8 and 11 of each cycle during cycles 1-8.
15889717|NCT03729791|Device|tDCS|Transcranial direct current stimulation (tDCS) is a form of neurostimulation that uses constant, low direct current delivered via electrodes on the head. It can be contrasted with cranial electrotherapy stimulation, which generally uses alternating current the same way
15889718|NCT03729778|Biological|Prevnar-13|One time administration of prevnar-13 vaccine
15889719|NCT03729765|Device|hemoperfusion|The patients in the simultaneous hemoperfusion arm will receive hemoperfusion when extracorporeal membrane oxygenation (ECMO) is commenced. veno-arterial extracorporeal membrane oxygenation (VA-ECMO) patients treat with hemoperfusion three times in a row，each time for 6 hours.
15889720|NCT03729752|Drug|[89]Zr-DFO-VRC-HIVMAB060-00-AB|Radiolabeled monoclonal antibody that targets the envelope protein of HIV-1.
15889721|NCT03729739|Diagnostic Test|QFR-based diagnostic strategy|Novel computer based calculation of lesion severity. Pressure wire-free and adenosine-free
15889722|NCT03729739|Diagnostic Test|FFR-based diagnostic strategy|Standard FFR based diagnostic method. Pressure drop across the stenosis is measured with a pressure wire during medical induced hyperaemic conditions
15889723|NCT03729726|Behavioral|Future Foundation 2.0 PREIS Program|The Future Foundation 2.0 PREIS intervention model uses a placed-based collective impact framework to provide a comprehensive intervention model, including: academic support and college and career readiness services, evidence-based social emotional learning instruction to strengthen protective factors and promote healthy transitions to adulthood, and trauma-informed, medically accurate, and age appropriate sexual health education. Moreover, the 2.0 PREIS program model features a unique student advocacy component designed to ensure that youth and their families receive the wraparound supports necessary for their students to remain on track for school success.
15889724|NCT03729713|Other|Computerized cognitive rehabilitation|6 week course of cognitive rehabilitation focused on attention, learning, and memory
15889725|NCT03729713|Other|Sham placebo|an alternative home-based computer program not designed for cognitive remediation but of the same duration
15889726|NCT03729700|Other|Almond|The almond dose will be provided as 20% of total energy (20% E) in the diet.
15889727|NCT03729687|Combination Product|radiotherapy, capecitabine, oxaliplatin|5x5 Gy radiotherapy in 1 week, 4 cycles of CAPOX (capecitabine 1000 mg/m2 x2 d 1-14, oxaliplatin 130 mg/m2 d 1 every third week), surgery
15889728|NCT03729674|Drug|Biosimilar|Biologic-naïve patients starting any biosimilar; patients switching to biosimilar from an alternative biologic therapy; or patients switching to a biosimilar after successfully completing and exiting a previous course of therapy with the equivalent originator drug.
15889729|NCT03729674|Drug|Originator (legacy) drug|Biologic-naïve patients starting any originator (legacy) drug; patients switching to an originator drug from an alternative biologic therapy; or patients starting a new cycle with the originator drug.
15889730|NCT03729661|Behavioral|Nasal High Flow Therapy|Use of Nasal High Flow Therapy during CT and treatment
15889731|NCT03729648|Behavioral|Expressive Arts Therapy|The intervention brings together the strengths of different art modalities, such as visual art, music, movement, dance, drama and writing to assist reflect and response in individuals to their personal issues. Such variety of art forms multiplies the avenues by which a person in therapy may seek meaning, clarity, insight and healing.
15889732|NCT03729635|Procedure|Pectoral-intercostal fascial plane block (PIFB)|Local anesthetic is infiltrated into the fascial plane between pectoralis major and the intercostal muscles lateral to the sternum to anesthetize the anterior cutaneous branches of the intercostal nerves.
15889733|NCT03729622|Other|Low FODMAP Diet|Both arms will receive the intervention but at different time points.
15889734|NCT03729609|Drug|Brentuximab vedotin (Genetical Recombination)|Brentuximab vedotin Intravenous Infusion
15889737|NCT03729583|Behavioral|Pulmonary Rehabilitation|A 12 week high intensity PR programme was delivered to both groups. The active group had additional breathing control interventions and exercises
15889801|NCT03729089|Other|Modified Biophysical Profile scan|Modified biophysical profile scan to be done in third trimester for eligible pregnant mothers
15890021|NCT03727074|Drug|5-FU Cream|topical cream twice a day
15889738|NCT03729570|Other|ePrEP|Participants will have a baseline teleconsultation with a site study clinician who will be responsible for prescribing PrEP as indicated. They will be offered a 1-month check-in and telemedicine consultations at 3, 6, 9 and 12 months. Participants will complete home specimen collection for laboratory tests for each consultation. The virtual study visit consists of surveys, specimen collection, and a telemedicine consultation.
15889739|NCT03729557|Procedure|Nephrectomy|Unilateral nephrectomy
15889740|NCT03729544|Behavioral|On-screen computerized decision support alert|On-screen electronic alert during the outpatient clinical encounter that notifies him or her that the patient should be screened for CTEPH
15889741|NCT03729531|Procedure|Conventional vein harvesting technique|Long incision will be used to expose the vein, the perivascular tissue will be dissected carefully by scissors, to check for leakage, the vein will be distended by injecting saline.
15889742|NCT03729531|Procedure|no-touch vein harvesting technique|The vein will be harvested by low-frequency electrotome, about 5mm surrounding tissue will be preserved with the vein, distention should be avoided, the vein will not be cut off until being anastomosed.
15889743|NCT03729518|Radiation|Radiation Therapy (IMRT or IMPT)|"Treatment of the primary tumor bed will be omitted in appropriate patients, as per the initial TORS de-intensification protocol. In those patients requiring treatment of the primary site, reduced dose (50 Gy) will be delivered.
~Receipt of concurrent chemotherapy per current guidelines. Chemotherapy may be omitted in patients with focal or microscopic ENE (defined as ≤ 1 mm ENE), at the discretion of the treating Medical Oncologist.
~Blood samples will be obtained at time of enrollment, and at two time points during RT, to quantify circulating HPV DNA and perform immune profiling."
15889744|NCT03729505|Procedure|Pyloric injection of magnesium sulfate and lidocaine mixture|100 mg / 2 ml of magnesium sulphate (Magnesium Sulfate®) is mixed with 5 ml of 2% lidocaine and injected in the pylorus
15889745|NCT03729505|Procedure|Pyloric injection of saline|5 ml of normal saline is injected in the pylorus
15889746|NCT03729492|Diagnostic Test|CTEPH/CTED work-up|Patients diagnosed with acute pulmonary embolism (PE) in Region Midt (approx. 350 per year) will be screened for non-recovery or persistent PE related symptoms during their 3-6 months follow up at their local outpatient clinic. If the patient has persistent symptoms they will be referred to a V/Q-scan. If a V/Q mismatch is present, the patient will be referred to a full work-up for CTEPH/CTED.
15889747|NCT03729479|Behavioral|DASH diet|Participants will be taught to follow a DASH diet (low-sodium and low-fat meal plan, which includes whole grains, fat-free or low-fat dairy products, vegetables, fruits, poultry, fish, and nuts, with processed, high-sodium, regular-fat, and sugar-added foods restricted).
15889748|NCT03729479|Behavioral|Very low carbohydrate, ketogenic diet|Participants will be taught to follow a very low-carbohydrate diet (non-starchy vegetables, nuts, seeds, meat, fish, and natural fats such as avocado, olive oil, and butter, with starchy and sugary foods restricted).
15889749|NCT03729479|Behavioral|Extras|Participants will be given training in positive affect, mindfulness, health information seeking and sharing, and cooking practices and behavior.
15889750|NCT03729466|Other|clinical pilates|The intervention group will be performed in clinical pilates 45 to 60 minutes twice a week for 8 weeks.
15889751|NCT03729453|Device|SpyGlass|Visualization of main pancreatic duct with SpyGlass catheter.
15889752|NCT03729440|Behavioral|development of complications or not|assessment of development of complications
15889753|NCT03729427|Procedure|Erector Spinae Plane Block|Erector Spinae Plane block for patents undergoing rib cartilage grafting surgeries
15889754|NCT03729414|Procedure|mucopexy with Doppler artery ligation|Hemorrhoids will be treated by mucopexy with Doppler guided hemorrhoids arteries ligation performed in all quadrants
15889755|NCT03729414|Procedure|mucopexy without Doppler artery ligation|Hemorrhoids will be treated by mucopexy alone performed in all quadrants
15889756|NCT03729401|Drug|Active Comparator: Dual Antiplatelet Therapy (DAPT) - Aspirin 81 mg + Ticagrelor 60mg twice daily|DAPT with aspirin and ticagrelor
15889757|NCT03729401|Drug|Ticagrelor Monotherapy: Ticagrelor 60 mg twice daily|Ticagrelor monotherapy
15889758|NCT03729401|Drug|Personalized Therapy Arm: Aspirin 81 mg or Ticagrelor 60mg twice daily or Clopidogrel 75 mg once daily|Personalized therapy based on risk score and genotyping
15889759|NCT03729388|Other|Prognosis factor associated with good outcome.|Implementation of a systematic assessment of patient with OMT initiation. Patients included in the TOPAZE study will receive standardized clinical interviews, electrocardiograms, urinary and blood tests during a 12 months follow-up.
15889760|NCT03729375|Drug|10cc injection of bupivacaine|10cc intra-operative injection of bupivacaine into the carpal tunnel of the operative hand/wrist
15889761|NCT03729375|Drug|20cc injection of bupivacaine|20cc intra-operative injection of bupivacaine into the carpal tunnel of the operative hand/wrist
15889762|NCT03729362|Drug|AT2221|Participants received ATB200 co-administered with AT2221 (Miglustat)
15889763|NCT03729362|Biological|alglucosidase alfa|alglucosidase alfa via intravenous infusion as prescribed by the participant's treating physician and in accordance with the approved prescribing information via intravenous infusion as prescribed by the participant's treating physician and in accordance with the approved prescribing information
15889764|NCT03729362|Biological|ATB200|Enzyme Replacement Therapy via intravenous infusion
15889766|NCT03729336|Device|Midstream urine collection device|Non-invasive midstream urine collection device
15889767|NCT03729336|Device|Catheter for urine collection|In-and-out catheter obtains urine through the urethra.
15889768|NCT03729323|Behavioral|Motivational interviewing|In Diabetes and hypertension, nursing consultations to support the care should be focused on their educational component the orientation of measures that prove to reduce blood pressure, improve the glycemic indices, the lipid profile and the Cardiovascular risk classification, among them: adherence to drug therapy, proper diet, body weight maintenance, stimulating active life and regular physical exercise, reducing alcoholic beverage consumption, reducing stress and abandoning Smoking. In this group, these care will be addressed based on the principles and techniques of the Motivational Interviewing.
15889802|NCT03729076|Other|Crystalloid|Patients will receive the rapid co-loading with plasma solution A (PSA) 10ml/kg, from the initiation of spinal anesthesia, within 10 minutes.
15890022|NCT03727074|Drug|Efudex®|topical cream twice a day
15890023|NCT03727074|Drug|Vehicle|topical cream twice a day
15889769|NCT03729323|Behavioral|Nursing Consultation|In Diabetes and hypertension, nursing consultations to support the care should be focused on their educational component the orientation of measures that prove to reduce blood pressure, improve the glycemic indices, the lipid profile and the Cardiovascular risk classification, among them: adherence to drug therapy, proper diet, body weight maintenance, stimulating active life and regular physical exercise, reducing alcoholic beverage consumption, reducing stress and abandoning Smoking. In this group, these care will be approached in a conventional manner, as routine of the services, based on the recommendations of the Primary Care Strategy Notebooks for the care of chronic conditions in DM2 and SAH and the SSC-GHC Institutional Protocol for SAH and DM2 Patient Care.
15889770|NCT03729310|Device|Propel 'implant'|The Propel 'implant' is composed of small, flexible tubes which dissolve while releasing Mometasone which is one type of steroid. This application has been approved for use by the FDA.
15889771|NCT03729310|Drug|Triamcinolone|Triamcinolone has been approved for use topically elsewhere on the body, although the specific use of Triamcinolone in the sinuses has not been approved by the FDA.
15889772|NCT03729310|Device|Nasopore|"This packing' is a sponge-like material which dissolves while releasing triamcinolone."
15889773|NCT03729297|Drug|Cabozantinib|cabozantinib tablets (Cabometyx®) once daily until progressive disease, intolerable toxicity, or investigator and/or patient decision to withdraw for a maximum duration of 2 years.
15889774|NCT03729284|Drug|Cymbalta Capsules|Active Comparator: Cymbalta®- hard gelatinous capsule with delayed release microgranules ( Eli Lilly do Brasil Ltda) equivalent to 60 mg of duloxetine.
15889775|NCT03729284|Drug|Duloxetine Hydrochloride Capsules|Experimental Drug: Duloxetine hydrochloride - hard gelatinous capsule with delayed release microgranules (Pfizer S.R.L - Argentina.) equivalent to 60 mg of duloxetine.
15889776|NCT03729271|Drug|Rifaximin|Rifaximin will be given during weeks 2-4
15889777|NCT03729271|Device|Glucose and lactulose hydrogen breath testing|Subjects will undergo glucose and lactulose hydrogen breath tests for Small Intestinal Bacterial Overgrowth (SIBO) on consecutive days using a commercially available home base kits (Glucose Hydrogen Breath Test Collection Kit and Lactulose Hydrogen Breath Test Collection Kit for SIBO from Commonwealth Diagnostic International) prior to Rifaximin treatment and at week 13 of the study.
15889778|NCT03729258|Drug|Infex 400 MR|Infex (cefpodoxime) 400mg once a day (QD) for 10 days
15889779|NCT03729258|Drug|Infex 200 IR|Infex (cefpodoxime) 200mg twice a day (BID) for 10 days
15889780|NCT03729245|Biological|bempegaldesleukin|Specified dose on specified days
15889781|NCT03729245|Drug|sunitinib|Specified dose on specified days
15889782|NCT03729245|Biological|nivolumab|Specified dose on specified days
15889783|NCT03729245|Drug|cabozantinib|Specified dose on specified days
15889784|NCT03729219|Biological|E. coli ETVAX|Oral suspension Sterile water is added to dmLT . Vaccine is poured to the effervescent solution and needed amount of dmLT is added.
15889785|NCT03729219|Other|Placebo|Oral suspension
15889786|NCT03729206|Diagnostic Test|intravital microscopy|intravital microscopy with sidestream dark-field imaging
15889787|NCT03729193|Behavioral|Measuring devices and questionnaires|Measuring devices and questionnaires will be applied to assess the pain and psychosocial states of musculoskeletal system of athletes. The Expanded Scandinavian Muscle Skeleton Questionnaire (NMQ) and Visible Analogue Scale (VAS) will be used to identify and assess the symptoms of musculoskeletal discomfort as 'pain'. The participant will be evaluated with the algometer for identifying their pain threshold, the sporty trust will be questioned with the Sporty Trust Continuous Inventory, and the Quality of Life will be assessed with the World Health Organization Quality of Life Scale Short Form and Depression will be evaluated with Beck Depression Inventory.
15889788|NCT03729180|Procedure|Routine Elective Surgery- In patient or out patient elective surgery|Participants will be undergoing routine planned surgeries.
15889789|NCT03729180|Diagnostic Test|Blood test for genetic testing|Blood test to determine differences in genes which may affect how certain medications affect the participant. All patients will consent to collection of a blood sample for preemptive genotyping across a panel of actionable germline variants predicting drug response or toxicity risk.
15889790|NCT03729180|Other|Drug-genetic Profile|Profile describing drugs that may be high-risk, those that should be used with caution, or drugs that are favorable to use based on the participants genes.
15889791|NCT03729167|Procedure|Scaling and root planing|Non-surgical instrumentation will be performed with specific instruments prior to treatment planned extraction by another provider.
15889792|NCT03729154|Behavioral|First Step|First Step is a comprehensive early intervention that is delivered by a behavioral coach who works in collaboration with the classroom teacher and parents. First Step addresses moderate to severe behavior problems of young children and includes both classroom and home components. The program takes about three months from start to finish and requires approximately 60 hours of the coach's time for implementation over this three month period.
15889793|NCT03729141|Dietary Supplement|Added Cholesterol|Participants assigned to the added cholesterol group will receive snacks containing added cholesterol (1g/day) for 3 weeks prior to surgery.
15889794|NCT03729141|Other|No Added Cholesterol|Participants assigned to the no added cholesterol group will receive snacks containing no added cholesterol for 3 weeks prior to surgery.
15889795|NCT03729128|Drug|dextromethorphan and memantine (DM+MM)|Patients of Amphetamine-type stimulants use disorder (ATSUD) will take dextromethorphan 30 mg/day and memantine 5 mg/day combination (DM+MM) daily for 12 weeks.
15889796|NCT03729128|Drug|Placebos|Patients of Amphetamine-type stimulants use disorder (ATSUD) will take placebos daily for 12 weeks.
15889797|NCT03729115|Procedure|Magnetic Resonance Imaging (MRI)|Patients will have MRI scans every 6 months.
15889798|NCT03729115|Other|Clinical Hypnosis|Patients will provided with an audio recording which includes the technique of Clinical Hypnosis to help manage anxiety during MRI scans.
15889799|NCT03729115|Other|Anxiety Self-management Techniques|Participants will be given a workbook with tools and techniques to help manage anxiety and stress related to getting the MRI scans and their overall healthcare.
15889800|NCT03729102|Biological|Blood drawn after rabies vaccine booster vaccination|All participants would be given one dose of rabies vaccine and monitor the immunological cells i.e., regulatory T cell, regulatory B cell, T follicular helper cells, cytokines i.e., IL-10, TGF-Beta, and Rabies neutralizing antibody titers, before and after the booster injection
15890024|NCT03727061|Biological|Nivolumab|Immunotherapy - Standard of care
15889803|NCT03729076|Other|Colloid|Patients will receive the rapid co-loading with 6% volulyte (HES in acetated electrolyte) 10ml/kg, from the initiation of spinal anesthesia, within 10 minutes.
15889804|NCT03729063|Other|Twice-daily expired carbon monoxide (CO) measurements|Patients included in this arm will have expired CO measurements every morning and evening during their initial hospitalization.
15889805|NCT03729063|Other|Minimal control|Patients included in this arm will have one expired CO measurement on the morning just after initial hospital admission and a second expired CO measurement one the morning prior to discharge.
15889806|NCT03729050|Behavioral|Rehabilitation Coordinator in Specialist Psychiatry|Rehabilitation Coordinator service in Specialist Psychiatry
15889807|NCT03729037|Other|CPR self-training|
15889808|NCT03729024|Device|Light Adjustable lens (LAL) and Light Delivery Device (LDD)|Primary and Fellow eyes will receive Light adjustable lens with Light delivery Device treatments
15889809|NCT03729011|Drug|Volatile agent|Patients will receive volatile agent to provide general anaesthesia, including CPB period. Volatile agents will be administered from anesthesia induction to the end of surgery. Concentration (MAC) of volatile agent will be selected by anaesthesiologist according to clinical situation and patient features.
15889810|NCT03729011|Drug|Propofol|Patients will receive propofol and no volatile agent. Propofol will be used for induction and maintenance of anesthesia.
15889811|NCT03728998|Other|Passive leg raise (PLR)|"A PLR will simulate an autotransfusion of 250-300 cc.
~1. Starting in semi-succumbed position (45 degree head-up)
~2. PLR is performed by lowering head-end and putting a for this purpose designed device of 45 degrees under the patients legs. The PLR is non-invasive."
15889812|NCT03728998|Other|Clearsight non-invasive hemodynamic monitoring system|3 baseline readings will be done for CO, CI, SV and SVR, separated by one minute intervals. Subsequently, the standardized passive leg-raise test will be performed and measurements of CO, CI, SV and SVR will be repeated at 30, 60, 90 and 120 seconds. Then the patient is repositioned to his original position, and after two minutes another reading of CO, CI, SV and SVR is done. Then all patients will receive a fluid challenge of 500cc natriumchloride 0.9% IV, considered as normal treatment/ common practice in our ED. 120 seconds after finishing the fluid challenge the final reading of CO, CI, SV and SVR is done.
15889813|NCT03728985|Device|GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis|Endovascular Aortic Stent-Graft
15889814|NCT03728972|Drug|Pembrolizumab|200mg IVPB every 3 weeks
15889815|NCT03728959|Other|Liquid meal (Nutridrink)|Liquid meal ingested over 1 minute.
15889816|NCT03728959|Other|GIP|Subcutaneous injected GIP
15889817|NCT03728959|Other|GLP-2|Subcutaneous injected GLP-2
15889818|NCT03728959|Other|Placebo (saline)|Subcutaneous injected Placebo (saline)
15889819|NCT03728946|Drug|Liposomal Bupivacaine|Addition of 15mL of liposomal bupivacaine to 15mL of standard nerve block anesthetic solution containing 0.5% bupivacaine and 4mg of decadron
15889820|NCT03728933|Drug|Rotigotine 1 milligram/24 hours|Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 1 milligram (mg)/24 hours (h) (5 square centimeter (cm^2) patch size).
15889821|NCT03728933|Drug|Rotigotine 2 milligram/24 hours|Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: Application of rotigotine transdermal patch with 2 milligram (mg)/24 hours (h) (10 square centimeter (cm^2) patch size).
15889822|NCT03728933|Drug|Placebo|Pharmaceutical Form: transdermal patch Route of administration: transdermal use Concentration: not applicable
15889823|NCT03728920|Other|Muscle strength measurement|Patients awaiting hip arthroscopy will undergo muscle strength testing pre- and post-operatively. There will be no deviation of treatment from their NHS care. Validated outcome measure questionnaires will be completed at five months post-operatively. Magnetic resonance imaging and electromyography tests will be performed on a subset of patients post-operatively.
15889824|NCT03728907|Device|Hearing aid fitting technique- audiologist or user-adjusted|See information under 'arm' description
15889825|NCT03728894|Drug|Midazolam-hydroxyzine with 100% O2|Patients received Oral Sedatives with 100% O2 ,Behavior was assessed using the modified Houpt behavioral rating scale, by evaluating the videotapes of all patients at both the pretreatment and treatment phases.
15889826|NCT03728894|Drug|Midazolam-hydroxyzine with 50% N2O/O2|Patients received Oral Sedatives with 50% nitrous ,Behavior was assessed using the modified Houpt behavioral rating scale, by evaluating the videotapes of all patients at both the pretreatment and treatment phases.
15889827|NCT03728881|Biological|Quadrivalent Human Papillomavirus (types 6, 11, 16, 18) Recombinant Vaccine|Given IM
15889828|NCT03728881|Biological|Recombinant Human Papillomavirus Bivalent Vaccine|Given IM
15889829|NCT03728868|Dietary Supplement|Placebo|Dietary supplementation with placebo once a day for 8 consecutive weeks
15889830|NCT03728868|Dietary Supplement|High dose F. prausnitzii and D. piger|Dietary supplementation with high dose F. prausnitzii and D. piger once a day for 8 consecutive weeks
15889831|NCT03728868|Dietary Supplement|Low dose F. prausnitzii and D. piger|Dietary supplementation with low dose F. prausnitzii and D. piger once a day for 8 consecutive weeks
15889832|NCT03728855|Behavioral|Self-administration of medication (SAM)|Patients use medication from their own stock, self-administered.
15889833|NCT03728842|Other|Blood collection for laboratory studies|Peripheral whole blood will be collected
15889834|NCT03728842|Other|Data collection from medical record|Clinical data such as demographics and cancer characteristics, history and treatment will be collected
15889835|NCT03728829|Drug|Trastuzumab+TP|Trastuzumab (4 mg/kg loading dose, then 2 mg/kg I.V., every week, totally 17 weeks (6 cycles)) combined with TC neoadjuvant chemotherapy (Docetaxel 75 mg/m2 I.V., day 1, Carboplatin 400 mg/kg, I.V., day 2, every 3 weeks, totally 6 cycles).
15889836|NCT03728803|Device|Threshold IMT, Philips Respironics, Murrysville, PA, USA|Active inspiratory muscle training (IMT) by the threshold IMT provides consistent and specific pressure for inspiratory muscle strength and endurance training, regardless of how quickly or slowly patients breathe. This device incorporates a flow-independent one-way valve to ensure consistent resistance and features an adjustable specific pressure setting (in cmH20) to be set. When patients inhale through the Threshold IMT, a spring-loaded valve provides a resistance that exercises respiratory muscles through conditioning.
15889917|NCT03728062|Behavioral|Physical exercise|Cardio exercise at gym like rowing, eliptical, cycling, or running outside.
15889837|NCT03728790|Device|Remote Patient Monitoring|Bluetooth-enabled blood pressure cuff to assess whether this technology helps providers collect more data regarding their patients' blood pressures in the postpartum period.
15889838|NCT03728777|Dietary Supplement|Resveratrol|Resveratrol supplementation 1000 mg /day or placebo
15889839|NCT03728764|Other|Preterm infant formula|Preterm infants will receive Stage 1 investigative product as soon as possible after birth until when 1.8 kg of body weight is achieved. Preterm infants will receive stage 2 preterm formula from when 1.8 kg of body weight is achieved until 1 month after hospital discharge.
15889840|NCT03728751|Procedure|Dry needling|Paravertebral dry needling C7-T4. Total of 8 needles.
15889841|NCT03728738|Procedure|Head of Bed Positioning|The head of bed (HOB) position will be selected through computerized randomization, and will include either zero degree positioning or thirty degree HOB elevation
15889842|NCT03728725|Device|Cepheid Gene Xpert MTB/XDR|The Xpert MTB/RIF assay (Cepheid, Sunnyvale, CA) is an integrated, automated, cartridge-based system for MDR-TB diagnosis that uses the GeneXpert instrument platform. WHO confirmed evidence to support the widespread use of the Xpert MTB/RIF assay in 2010 and the assay has since been widely used in TB programs, but it is only capable of identifying Mycobacterium tuberculosis (Mtb) and detecting RIF resistance. The Xpert MTB/XDR assay will be evaluated for INH and second-line resistance detection, and to recommend its use in diverse clinical settings. The focus of this protocol is the multicentre clinical evaluation.
15889843|NCT03728712|Diagnostic Test|SPECT/CT|"Technegas-Tc99m is approved by Health Canada for the evaluation of ventilation. Technegas will be prepared with a Technegas Generator (Cyclomedica) according to the manufacturer recommendations with a simmer phase and a burning phase. 95% ethanol will be used to wet the carbon crucible. The crucible will be loaded with 20-30 mCi of Tc99m. Tc99m has a physical half-life of 6 hours.
~Technegas will be administered to the patient within 10 minutes of its preparation, in a separate room than the scanning room. The inhalation technique will be rehearsed with the patient prior to the actual inhalation. The patient will be in supine position. A mouth piece and a nose clip will be used. The patient will be instructed to take 3 breaths of Technegas, starting after normal exhalation. A survey meter will be used to monitor the quality of the inhalation."
15889844|NCT03728699|Diagnostic Test|Sample Collection Blood|Collected from each patient twice weekly.
15889845|NCT03728699|Diagnostic Test|Stool Sample|Collected from each patient twice weekly.
15889846|NCT03728686|Other|Different given time|Fentanyl 2mcg/kg (F) was given at either 1,2,3 minutes before intubation
15889847|NCT03728673|Drug|Escitalopram Oral Tablet|Active capsules will contain 10 mg escitalopram oxalate.
15889848|NCT03728660|Device|Virtual bioptic magnification with large field of view|The intervention device will have a larger field of vision than the legacy device and the intervention device will also have a virtual bioptic telescope mode not found on the legacy device. The user will be able to adjust the size of the virtual bioptic telescope and the amount of magnification with a touch pad on the side of the head-mounted display (HMD).
15889849|NCT03728660|Device|Full field magnification with small field of view|Comparison intervention with user-controlled full field magnification with a smaller field size shared by legacy head-mounted devices. User can control amount of magnification
15889850|NCT03728647|Behavioral|multimedia health education|The program (flat touch computer) consisted of knowledge and technology levels. Knowledge: diabetic introduction, treatment, management of hyper- and hypoglycemia, complications, and experience sharing of insulin injection by a patient group. Technology: steps of insulin injection skills and complete technology demonstration . The program contents were organized using a unit-based piecemeal teaching approach. Participants could adjust their learning pace according to individual situations and could practice injection skills using an injection mold during hospitalization. A diabetes educator has assessed the learning outcome of each participant after intervention. At the day of discharge from hospital, each participant would acquire a copy of the multimedia health education compact disc.
15889851|NCT03728647|Behavioral|regular health education|The traditional education program (a diabetes educator) consisted of knowledge and technology levels. Knowledge: diabetic introduction, treatment, management of hyper- and hypoglycemia, and complications. Technology: steps of insulin injection skills and complete technology demonstration.
15889852|NCT03728634|Drug|AKCEA-TTR-LRx|Single and multiple doses of AKCEA-TTR-LRx administered subcutaneously
15889853|NCT03728634|Drug|Placebo|Placebo comparator calculated volume to match active comparator administered subcutaneously
15889854|NCT03728621|Behavioral|Normocaloric and balanced diet, physical activity|Promotion of normocaloric & balanced diet and physical activity
15889855|NCT03728608|Device|Feeding tube dwell time of 48 hours|Feeding tube dwell time of 48 hours for first 4 weeks of life.
15889856|NCT03728608|Device|Feeding tube dwell time of 7 day|Feeding tube dwell time of 7 days for first 4 weeks of life.
15889857|NCT03728595|Diagnostic Test|Venepuncture|A blood sample will be taken for serum bicarbonate
15889858|NCT03728595|Diagnostic Test|Spirometry|All patients who have not had a spirometry in the 12 months prior to the HAST will undergo one on the day of the HAST.
15889859|NCT03728595|Diagnostic Test|Hypoxic altitude simulation test (HAST)|HAST will be performed as per clinical team request. No changes to this intervention will be made for research purposes.
15889860|NCT03728582|Device|Active tDCS plus Speech-Language Therapy|1 milliamp (mA) of Anodal tDCS stimulation is induced between 5cm X5 cm saline soaked sponges where one sponge is placed on the left inferior frontal gyrus (IFG). The stimulation will be delivered at an intensity of 1 mA in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy will be verb naming therapy in a sentence context.
15889861|NCT03728582|Device|Sham tDCS plus Speech-Language Therapy|Sham tDCS stimulation is provided to the left inferior frontal gyrus (IFG) using a tDCS device. Speech-language therapy will be verb naming therapy in a sentence context.
15889862|NCT03728569|Other|Vanicream Moisturizing Skin Cream|Vanicream Moisturizing Skin Cream daily application
15889863|NCT03728569|Other|Vanicream Cleansing Soap|Vanicream Cleansing Soap daily use
15889864|NCT03728556|Biological|CS1001 monoclonal antibody|Participant will receive CS1001 monoclonal antibody 1200 mg by intravenous infusion every 3 weeks, for up to 24 months
15889865|NCT03728556|Biological|CS1001 placebo|Participant will receive CS1001 placebo by intravenous infusion every 3 weeks, for up to 24 months
15889977|NCT03727464|Behavioral|Controls|Patients did not receive any specific stimulation with words during their general anesthesia
15889866|NCT03728543|Drug|Sugammadex|"Introductory anesthesia: sevoflurane up to 8 rev /% + Air + O2 or propofol 1% 2 mg / kg intravenously.
~Maintenance: sevoflurane up to 3 rev /% + Air + O2, introduction of rocuronium bromide in a dose of 0.4 mg / kg, intravenously, as a bolus injection.
~At the end of anesthesia: sugammadex in a dose of 2 mg / kg, intravenously, as a bolus injection"
15889867|NCT03728530|Other|Deep Breathing exercises|"In pursed lip exercise subject was guided to inhale through nose with mouth closed and exhale through pressed lips (pursed lips).
~In Diaphragmatic breathing subject was instructed to place his one hand below the rib cage and the other hand on chest. The patient inhaled slowly so that stomach moves out against the hand. Tighten the stomach muscle while exhaling through pursed lip.
~In powered breathing subject was to inhale and exhale forcefully with some movements like subject was instructed to inhale forcefully while moving his hands upward and exhale forcefully while moving hands downward.
~These three exercise techniques were advised to each subject of experimental group. They have to practice these exercises 3-4 times a day with 10 repetitions each. These exercises can be performed in sitting position or in supine lying position. Subject can adopt any position in which he feels comfortable."
15889868|NCT03728504|Drug|ASN002|Daily dose of ASN002 for 32 weeks
15889869|NCT03728504|Drug|Placebo Oral Tablet|Daily dose of Placebo Oral Tablet for 16 weeks
15889870|NCT03728491|Device|Simulator|US Mentor simulator, lung module, provided by 3D Healthcare Systems
15889871|NCT03728491|Device|Healthy figurants|Medical students or volunteers without any pathology in thorax
15889872|NCT03728478|Drug|Etanercept|Patients will receive etanercept subcutaneously at a dose of 0.8 mg/kg weekly (up to a maximum dose of 50 mg weekly).
15889873|NCT03728478|Drug|Methotrexate|Methotrexate will be administered subcutaneously, in a single weekly dose of 15 mg/m2 (max 20 mg).
15889874|NCT03728478|Drug|Intra-articular corticosteroid injections|Triamcinolone hexacetonide and methylprednisolone acetate doses depend on the affected joint.
15889875|NCT03728465|Biological|Nivolumab|In the induction phase of this study nivolumab is administered as a IV infusion in combination with ipilimumab at a dose of 1 mg/kg for 4 cycles at three weeks interval and in a maintenance phase alone at a dose of 3 mg/kg every two weeks.
15889876|NCT03728465|Biological|Ipilimumab|In the induction phase of this study ipilimumab is administered as a IV infusion in combination with nivolumab at a dose of 3 mg/kg for 4 cycles at three weeks interval.
15889877|NCT03728452|Procedure|Trophic Nutrition|"According to previously published studies of Trophic Nutritions in critically ill patients, an energy goal of 20-30% estimated caloric needs of 20-30 kcal / kg and a protein intake of 1.2 to 2.0 g / kg / day of proteins will be established. at most 72 hours after the start of nutritional therapy.
~The rhythm of initiation and increase of enteral contributions will be at the discretion of each participating ICU. Prokinetic or parenteral nutrition (PN) complementary will not be used routinely, leaving its indication at the discretion of the responsible physician.
~A hyperproteic nutritional formula (10 g / 100 ml) will be used, with a caloric intake of 1.2 kcal / ml and a non-protein kcal / nitrogen ratio of 52: 1. TN will be administered over 23 hours each day by continuous infusion pump. The head of the patient's bed will rise above 30° as much as possible to reduce the risk of aspiration. The Gastric Residue Volume (GRV) will be measured every 24 hours."
15889878|NCT03728439|Device|LED before|Phototherapy will be applied through LED therapy equipment, with 15 light emitting diodes that produce 8 joules (J) per diode and 120 joules in total. The muscular regions irradiated will be the quadriceps, hamstrings and triceps sural, with two points of application in each muscle group.
15889879|NCT03728439|Device|LED interval|Phototherapy will be applied through LED therapy equipment, with 15 light emitting diodes that produce 8 joules per diode and 120 joules in total. The muscular regions irradiated will be the quadriceps, hamstrings and triceps sural, with two points of application in each muscle group.
15889880|NCT03728439|Device|LED after|Phototherapy will be applied through LED therapy equipment, with 15 light emitting diodes that produce 8 joules per diode and 120 joules in total. The muscular regions irradiated will be the quadriceps, hamstrings and triceps sural, with two points of application in each muscle group.
15889881|NCT03728426|Drug|Letermovir|"Patients will receive intravenous or oral letermovir at a dose of 480mg/day.
~Patients weighing 40 or more kilograms will receive a second, loading, dose 12 hours after the first dose of letermovir treatment.
~For patients receiving concomitant cyclosporine treatment, the letermovir dose will be 240mg/day."
15889882|NCT03728413|Biological|RSV A Memphis 37|"Subjects will be inoculated using intra-nasal drops with diluted inoculum at a given dose divided equally between the two nostrils. Dose: Good Manufacturing Practices-certified RSV Memphis 37 10(4) PFU in 1ml, 25% sucrose/Dulbecco's Modification of Eagle's Medium. Inoculations using intranasal drops will be done using a 1mL pipette with subjects supine. This will be done slowly with sufficient interval between each inoculation (2-3 minutes) to ensure maximum contact time between with the nasal and pharyngeal mucosa. Subjects will be asked not to swallow during the procedure to ensure maximal pharyngeal contact.
~Following inoculation, advice regarding hand hygiene will be given, subjects will be provided with alcohol hand gel and facemasks to reduce spread of virus in the environment."
15889883|NCT03728387|Other|Clinical Pilates Exercise|All evaluations of the individuals included in the study will be done by the physiotherapist.. For the second evaluation the same individuals will be visited by the same physiotherapist at least 7 days after the first evaluation and only the FAB-T scale will be applied. 34 volunteer individuals who will be randomly choosen among 84 individuals will be given a 6-week exercise training program. According to this 6 week program, individuals will be admitted to the exercise training program for 45-60 minutes with a physiotherapist for 3 days in a week. The exercise program will consist of a warm-up, a strength training and a cool-down section. Various exercise methods (clinical pilates exercises) and tools will be utilized to improve balance and mobility. Third assessment of FAB-T will be applied only to individuals participating in the 6-week exercise training program.
15889884|NCT03728374|Drug|Anlotinib|Anlotinib ( 12mg, QD, PO, d1-14, 21 days per cycle)
15889885|NCT03728361|Biological|Nivolumab|Given IV
15889886|NCT03728361|Drug|Temozolomide|Given PO
15889887|NCT03728348|Diagnostic Test|mt-sDNA screening test|Stool samples will be collected by the subject for the mt-sDNA screening test.
15889888|NCT03728348|Procedure|Colonoscopy|Subjects will undergo a screening colonoscopy.
15889889|NCT03728335|Drug|Enasidenib Mesylate|Given PO
15889890|NCT03728322|Biological|iHSCs treatment group|iHSCs intravenous injection
15889891|NCT03728296|Biological|islet body|Transplanting islet bodies under the diaphragm
15889892|NCT03728283|Procedure|implant placement in combination with connective tissue grafting|A connective tissue graft of standardised dimensions was harvested from the palate under local anaesthesia and was stabilised over the implant's neck
15889893|NCT03728283|Other|Implant placement|Implants were placed following teh manufacturer's instructions
15889894|NCT03728270|Device|Patient Specific Titanium Eminoplasty|"The stages of virtual surgical planning and fabrication of patient specific titanium eminoplasty will be designed my Mimics 15 program.
~Once designed, the virtual design and surgery will be planned on a computer model where vital anatomical structures could be identified and thus could be avoided during surgery.
~After obtaining all the dataset needed from the CT scan, the collected data will be sent to the Egyptian soil, water and environmental institution for manufacturing, packing and sterilization of the patient specific titanium eminence.
~The patient specific titanium eminence will be inserted and secured with two to three screws of individual lengths according to the virtual plan.
~Functional mandibular movements were reproduced to confirm absence of subluxation and checked for interference and any required adjustments made.
~A multilayer closure of the incisions will be accomplished using Vicryl"
15889895|NCT03728270|Procedure|Inlay Autogenous Bone Graft|"* Steps to harvest the bone graft:
~Down-fracture of the articular eminence to be augmented with Inlay bone graft to increase the vertical height of the articular eminence. A green-stick fracture will be created avoiding a possible complete fracture of the lower segment of the eminence
~To obtain Inlay bone graft from the chin, anterior mandibular vestibule incision will provide good access to the mandibular symphysis."
15889896|NCT03728257|Behavioral|LTGO-Home Based Exercise|The LTGO intervention consists of two phases: Phase 1. Intensive home-based exercise training and behavioral coaching via a telerehabilitation platform, VISYTER (Versatile and Integrated System for Tele-Rehabilitation)/two-way video communication system. Interactive intervention sessions will be delivered to the home via real time video conferencing (up to 12 sessions and a behavioral contract plan to prepare for phase 2); and Phase 2. Transition to self-management. Three telephone sessions (3 monthly counseling sessions) will be delivered over 12 weeks to provide behavioral coaching and exercise reinforcement
15889897|NCT03728257|Behavioral|Enhanced Usual Care|Enhanced Usual Care (EUC) will involve delivery of monthly newsletters (6 newsletters) on the topics of post-lung transplant management, including food safety, environmental health, flu, mental health, etc. and the provision of a self-monitoring device.
15889898|NCT03728244|Drug|MEBO ointment|The pharmacological effects of MEBO are attributable to beta-sitosterol, isolated from phellodendron amurense, flavonoids mainly baicalin isolated from scutellaria baicalensis, alkaloids mainly berberine, isolated from coptis chinensi, Beeswax and sesame oil (Zhang et al., 2005).
15889899|NCT03728244|Drug|Hyaluronic Acid gel|Hyaluronic acid is a substance that is naturally present in the human body. It is found in the highest concentrations in fluids in the eyes and joints. The hyaluronic acid that is used as medicine is extracted from rooster combs or made by bacteria in the laboratory.
15889900|NCT03728231|Other|Complete blood count|taking blood sample from venous blood
15889901|NCT03728218|Device|Contact lenses (Orthokeratology)|Contact lenses
15889902|NCT03728218|Device|Contact lenses (Soft Multifocal)|Contact lenses
15889903|NCT03728205|Behavioral|Yoga|Twice weekly yoga sessions for 12 weeks
15889904|NCT03728192|Other|mangosteen extract|For Mangosteen group :DNA fragmentation assay is used to identify apoptosis.1×106 cells were harvested and treated with mangosteen pericarp extract for 48 h For Camptothecin group : Cells were also treated with standard anticancer drug Camptothecin to act as a positive control.
15889905|NCT03728179|Combination Product|Low dose irradiation + Nivolumab + Ipilimumab or Cyclophosphamide + Aspirin/Celecoxib|"Low Dose Radiation (RT): RT will be administered as single fractions every 2 weeks (Q2W) from cycle C0 to cycle C4. RT will be delivered to a number of metastatic deposits visible by PET/CT, at the PI's discretion.
~Cyclophosphamide: 200mg/m2 will be administered as intravenous infusion (IV) Q2W from cycle C0 to C4.
~Nivolumab: 240 mg will be administered as IV Q2W from cycle C1 to C4.
~Ipilimumab: 1mg/kg will be administered as IV every 6 weeks (Q6W) from cycle C1 to C4
~Aspirin: 300mg will be administered orally daily from cycle C1 to C4. All subjects will receive mandatory gastric prophylaxis with an oral H2 antagonist.
~Celecoxib: 200mg will be administered orally twice a day from cycle C1 to C4.
~At the end of cycle C4, patients eligible for maintenance will be treated with nivolumab at 240mg Q2W until progression or excessive toxicity; celecoxib will be maintained if the drug is well tolerated"
15889906|NCT03728166|Behavioral|Electronic alert|"On-screen electronic alert that notifies the provider about the increased risk for VTE after discharge and indication for thromboprophylaxis will be issued 48 hours after admission. This first on-screen electronic alert will provide the clinician with the opportunity to consider extended-duration, post-discharge thromboprophylaxis and start any required processes for prior authorization or medication coverage. The provider then will be given on-screen options to either order thromboprophylaxis (betrixaban or low-molecular weight heparin for 35 days) from a Extended-Duration VTE Prevention order template, follow a link to evidence-based practice guidelines, or defer prescribing extended-duration, post-discharge thromboprophylaxis."
15889907|NCT03728153|Drug|Fluoxetine 20 MG Oral Tablet|Once-daily dosing for 90 days
15889908|NCT03728140|Procedure|Self-spent Culture Medium|Replace embryo transfer solution with Self-spent culture medium in IVF-ET.
15889909|NCT03728127|Dietary Supplement|Brazilian cardioprotective diet|Brazilian cardioprotective diet prescription
15889910|NCT03728127|Dietary Supplement|Brazilian cardioprotective diet plus 30g/day of mixed nuts|Brazilian cardioprotective diet plus 30g/day of nuts (10g of peanuts, 10g of cashew nuts and 10g of Brazil nuts)
15889911|NCT03728114|Device|RIC|Adults allocated to the RIC group will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 200 mmHg over systolic blood pressure for five cycles of 5 min followed by 5 min of relaxation of the cuffs.
15889912|NCT03728114|Device|sham RIC|Adults allocated to the sham group will undergo a sham RIC procedure during which bilateral arm cuffs are inflated to a pressure of 60 mmHg for five cycles of 5 min, followed by 5 min of relaxation of the cuffs.
15889913|NCT03728101|Drug|Simvastatin, Dabigatran Etexilate|The subjects receive dabigatran etexilate with and without simvastatin administration
15889914|NCT03728088|Other|Rating scales concerning non-technical attributes|
15889915|NCT03728075|Device|Neuromuscular electrical stimulation (NMES)|NMES was placed on the quadriceps muscle of both legs
15889916|NCT03728062|Behavioral|Mindfulness meditation|Guided mindfulness meditation focused on breath sensations, thoughts and emotions.
15889918|NCT03728049|Diagnostic Test|CT-ADP performed during TAVI procedure|The CT-ADP will be performed in the catheterization laboratory and revealed to the operator. The decision to undertake corrective procedure will be based on CT-ADP on top of standard methods of PVR assessment.
15889919|NCT03728049|Other|No CT-ADP performed during TAVI procedure|PVR assessment with the standard methods only (TTE and/or angiography and/or hemodynamics but excluding TEE and CT-ADP). The decision to undertake corrective procedure will be left at the discretion of the operator.
15889920|NCT03728036|Behavioral|conventional rehabilitation|The investigated cohort will be exposed to 'standard care' including conventional rehabilitation therapy.
15889921|NCT03728023|Drug|AZD4205|SAD: 5mg, 20mg, 50mg, 100mg and 150mg MAD: low, medium and high dose once daily X14 days
15889922|NCT03728023|Drug|Placebo|Single dose in SAD and once daily for 14 days
15889923|NCT03728010|Diagnostic Test|Electrical impedance tomography. Pulmonary mechanics measurement.Arterial gas measurement. Esophageal pressure measurement|After general anesthesia, patients will be ventilated with three tidal volume level (4, 6 and 8 cc / Kg / IBW), in two levels of PEEP, 6 cm2 H20, and best PEEP, the latter obtained after a recruitment maneuver and decremental titration.
15889924|NCT03727971|Drug|Omalizumab Injection|The treatment is initiated with one injection with weight and serum-immunoglobulin E balanced omalizumab. After omalizumab treatment at ovulation it will again be collected material (blood samples, sputum, secretion of the vagina, secretion of the rectum, secretion of the uterus, microbiota). If no pregnancy has occurred after first IVF cycle, this will be repeated for 3 consecutive IVF cycles in total or until pregnancy has occurred.
15889925|NCT03727971|Drug|NaCl|The treatment is initiated with one injection with placebo. After placebo injection treatment at ovulation it will again be collected material (blood samples, sputum, secretion of the vagina, secretion of the rectum, secretion of the uterus, microbiota). If no pregnancy has occurred after first IVF cycle, this will be repeated for 3 consecutive IVF cycles in total or until pregnancy has occurred.
15889926|NCT03727958|Diagnostic Test|Lung and coronary CT assessment|Subjects will undergo simultaneous coronary arteries and thoracic CT assessment
15889927|NCT03727958|Diagnostic Test|Coronary CT assessment|Subjects will undergo coronary arteries CT assessment only
15889928|NCT03727945|Other|abdominopelvic exercise and posture|n=21 women received supervised abdominopelvic exercise with previous postural correction. During 12 sessions a specialized physiotherapist supervised to realization of progressive abdominopelvic exercises, previous explain postural correction pelvis, cervical and dorsal zone.
15889929|NCT03727945|Other|abdominopelvic exercise|n=21 women received supervised abdominopelvic exercise. During 12 sessions a specialized physiotherapist supervised to realization of progressive abdominopelvic exercises.
15889930|NCT03727932|Device|VioOne HIV Profile Supplemental Assay|The VioOne™ HIV Profile™ Supplemental Assay is an enzyme-linked immunosorbent assay (ELISA) for confirmation and differentiation of individual antibodies directed to various gene products of Human Immunodeficiency Virus Type 1 (HIV-1 Group M & Group O) and Type 2 (HIV-2) in human serum or plasma. The HIV Profile™ is intended as an aid in the diagnosis of infection with HIV-1 and/or HIV-2.
15889931|NCT03727919|Behavioral|Exoskeleton-assisted gait training|In the experimental groups, participants are provided with 1-hour sessions of gait training with robot assistance, 4 times per week for 4 weeks. Assistance is provided by the Ekso GT (Ekso Bionics, Richmond, CA, USA), an exoskeleton consisting of fitted metal braces that supports the legs, feet, and trunk of the patient. Powered motors drive knee and hip joints in the sagittal plane to assist during standing up and walking over level surfaces. Steps are initiated if an active weight-shift towards the stance leg is performed by the patient. The provided assistance in stance and swing is adaptable to the patient's ability and can be adjusted for each leg separately.
15889932|NCT03727906|Other|No pre-sleep arousal manipulation|As with the pre-sleep arousal up- and down-regulation nights, the participant will sleep in comfortable sound-proof and temperature-controlled bedroom and will go to bed and wake up at his/her self-reported usual school-week times. On this night, pre-sleep activities include watching television or reading a book.
15889933|NCT03727906|Other|pre-sleep arousal down-regulation|"On the low pre-sleep arousal night, about 30 min before lights-out, a 20 min session of relaxation-driven Virtual Reality (VR) + slow breathing will be conducted. Adolescents will be instructed to perform slow diaphragmatic breathing and to let the VR immersion guide them through this relaxation process."
15889934|NCT03727906|Other|pre-sleep arousal up-regulation|"On the high pre-sleep arousal night, an anticipatory stress procedure from the Trier Social Stress Test (TSST) will be used to elicit stress-induced ANS activation in the pre-sleep period. About 30 min before lights-out participants will be told that the following morning they will need to prepare and give a 5-min speech in front of a panel of assessors who will judge their performance and ask questions. Participants will be shown the testing room (set up with chairs, video camera, microphone)."
15889935|NCT03727893|Behavioral|Roller-based Intervention Group (IG)|A group of manual wheelchair users (MWUs) with spinal cord injury (SCI) that will complete an initial exercise education and a 12-week (3 sessions per week) evidence-based high-intensity interval training (HIIT) program using the roller-based WheelMill (WMS) system.
15889936|NCT03727893|Behavioral|Control Group (CG)|A group of manual wheelchair users (MWUs) with spinal cord injury (SCI) that will complete an initial exercise education session and enroll in a 12-week (3 sessions per week) independent workout program at an accessible community-based fitness facility.
15889937|NCT03727880|Drug|Pembrolizumab|Following standard of care neoadjuvant chemotherapy, subjects will receive two doses of pembrolizumab (200mg) IV 3 weeks apart prior to surgery. After surgery, subjects will receive adjuvant standard of care chemotherapy. Following adjuvant chemotherapy, subjects will receive 8 doses of pembrolizumab (200mg) IV 3 weeks apart.
15889938|NCT03727880|Drug|Defactinib|Following 2 cycles of standard of care neoadjuvant chemotherapy, subjects will receive 400 mg defactinib twice a day up until 2 days preceding their surgery (approximately 6 weeks) during the immunotherapy cycles with pembrolizumab. After surgery, subjects will receive adjuvant standard of care chemotherapy. Following adjuvant chemotherapy, subjects will receive 400mg defactinib twice a day for 24 weeks.
15889939|NCT03727867|Drug|Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor|Oral EGFR TKI begins on day 1 and continues until disease progresses.
15889940|NCT03727867|Device|Stereotactic Body Radiation Therapy|Participants were given Stereotactic Body Radiation Therapy in a dose of 60 Gy/8 fraction for the central tumor or 50 Gy/5 fraction for the peripheral lung cancer, respectively.
15889941|NCT03727854|Dietary Supplement|Premeal protein enriched bar|Subjects in the intervention group will intake protein enriched bar 15 minutes before each meals (at least twice a day).
15889942|NCT03727854|Behavioral|Dietary modification|Subjects in this group will follow diabetes diet education.
15889943|NCT03727841|Drug|Marizomib|0.8mg/m2 IV on days 1, 8, and 15 of each 28-day cycle, 24 cycles total.
15889944|NCT03727828|Diagnostic Test|Patients with heart failure|Participants will have serial blood collection on medical therapy for heart failure
15889945|NCT03727815|Other|Mindfulness Pain Management Arm|Mindfulness Pain Management intervention: patients will be asked to complete a guided mindfulness meditation intervention using a phone application for 2 weeks prior to participant's scheduled procedure and continue with the pain management mindfulness module for 4 weeks postoperatively with periodic survey assessments using validated psychometric tools.
15889946|NCT03727815|Other|Mindfulness Self Esteem Arm|Mindfulness Self Esteem intervention: patients will be asked to complete a guided mindfulness meditation intervention using a phone application for 2 weeks prior to participant's scheduled procedure and continue with the self esteem mindfulness module for 4 weeks postoperatively with periodic survey assessments using validated psychometric tools.
15889947|NCT03727802|Drug|TRK-250|single and multiple doses (4 weeks)
15889948|NCT03727802|Drug|Placebo|single and multiple doses (4 weeks)
15889949|NCT03727789|Drug|FACT Complex-targeting Curaxin CBL0137|Given IA
15889950|NCT03727776|Drug|Adrenocorticotropic Hormone|Adrenocorticotropic hormone (ACTH) is a melanocortin peptide hormone that is normally produced in the pituitary gland and acts as a major regulator of adrenal cortex function. It stimulates the adrenal cortex to produce and secrete glucocorticoids. ACTH is available for clinical usage as an injectable gel (H.P. Acthar®).
15889951|NCT03727763|Drug|Vemurafenib|960mg po bid
15889952|NCT03727763|Drug|Cetuximab|500mg/m2 iv gtt (14 days per course)
15889953|NCT03727750|Drug|Gemtuzumab Ozogamicin|Three doses of GO 3 mg/m2 (up to one vial) as a 2 hour intravenous infusion on Cycle 1 Days 1, 4, and 7. A second cycle of GO 3mg/m² (up to one vial) on Cycle 2 Days 1, 4, and 7 will be allowed at the investigator's discretion for patients who meet the criteria
15889954|NCT03727737|Device|Repetitive Transcranial magnetic Stimulation|RTMS will be delivered via magventure machine, on an approved FDA IDE protocol to DLPFC region to improve memory in older adults (veterans and non-veterans) with mild and moderate TBI.
15889957|NCT03727711|Other|TPTNS|We will be comparing hospital treatment to TPTNS at home
15889958|NCT03727698|Device|MR Linac|MR guided radiotherapy treatment
15889959|NCT03727685|Behavioral|Our Care Wishes|A flyer describing the Our Care Wishes platform will be added to the back pocket of admission packets for patients being admitted via the Silverstein 1 Admission Office and the Emergency Department and for patients being seen in the Pre Admission Testing office. Registration reps in these locations will inform all patients seen that Penn has created a free, online resource called Our Care Wishes to help patients with Advance Care Planning and ask if they would like to be sent a link to Our Care Wishes by email or text. For those patients who respond affirmatively, the rep will then complete the necessary fields to refer on www.ourcarewishes.org/refer.
15889960|NCT03727659|Behavioral|SHADE therapy + CONNECT FaceBook support|"See study arms description."
15889961|NCT03727646|Dietary Supplement|Nicotinamide riboside|nicotinamide riboside supplied as 250mg capsules
15889962|NCT03727633|Drug|Idarubicin and Lipiodol|Hepatic intra-arterial chemotherapy consisting of the hepatic intra-arterial injection Idarubicin, emulsified with Lipiodol
15889963|NCT03727620|Drug|amoxicillin plus metronidazole|patients were administered 250 mg of Flagyl and 500 mg of Dyspamox, three times a day for 7 days
15889964|NCT03727620|Drug|Doxycycline|patients were administered 200 mg of Longamycine the first day and 100 mg per day for 14 days
15889965|NCT03727607|Drug|Desflurane|Desflurane vs TIVA, bariatric surgery. Postoperative nausea and pain
15889966|NCT03727581|Diagnostic Test|Ultrasound guidance|Jugular vein is punctured with ultrasound guidance and guidewire is advanced. Right atrium and inferior vena cava junction is visualized by ultrasound using substernal view. Presence of guidewire in inferior vena cava or right atrium is confirmed. The procedure of catheter insertion is continued.
15889967|NCT03727568|Procedure|Cryobiopsy|"In this study the investigators want to evaluate the diagnostic yield comparing 2 different techniques of performing cryobiopsy. A shorter freezing time and more number of biopsies vs a longer freezing time and less number of biopsies would be compared. Patients are randomised to the groups 1 or 2 immediate before the bronchoscopy.
~Group 1: a total of 3 samples with a freezing time of 7 seconds at least for the first biopsy and freezing time for 5 seconds or more for the followings biopsies Group 2: a total of 8 samples with a freezing time of 3 seconds at least for the first biopsy and freezing time for less than 5 seconds for the followings biopsies"
15889968|NCT03727555|Genetic|Intracerebral LV gene therapy|Intracerebral LV gene therapy to deliver high levels lenvirus which carry normal ABCD1 gene at 1-2×10^9 multiplicity of infection/ml per site in multiple sites.
15889969|NCT03727542|Device|adjustment of atrioventricular delay in DDD packers|Atrioventricular delays are going to be adjusted as 60 milisecond shorter than the patients' native PR intervals in patients with already implanted permanent pacemakers.
15889970|NCT03727529|Other|Treadmill + VR|Patients will walk on the tredmill with the virtual reality headset. Patients will walk in a straight line in a coherent, immersive and simple virtual environment. Before the first session, a 15-minute session will focus on patient familiarization with iVR
15889971|NCT03727529|Other|Treadmill|Patients will walk on the treadmill without iVR. Patients will also receive a short familiarization to the treadmill before strating the experimentation.
15889972|NCT03727503|Other|PPV from the capstesia|we will challenge the application by doing 2 maneuvers: the first one is to increase the PEEP level from 5 to 15 cmH2O and the second one is the infusion of a mini-fluid challenge (100 ml) followed by the other 400 ml.
15889973|NCT03727490|Other|Repair|The subscapularis will be repaired.
15889974|NCT03727490|Other|Standard Treatment|No repair will be performed
15889975|NCT03727464|Behavioral|Abstract priming|Patients were primed with a list of abstract during their general anesthesia
15889976|NCT03727464|Behavioral|Concrete priming|Patients were primed with a list of concrete during their general anesthesia
15889981|NCT03727438|Behavioral|Tele-Self CBTI|The tele-self intervention is comprised of two treatment components: 1) self-management via a workbook with weekly readings, and 2) weekly telephone-based nurse support over 6 weeks
15889982|NCT03727438|Other|Health Education Control|6 weekly phone calls from a study nurse on a range of health topics (non-sleep), similar call duration to intervention phone calls. At the end of the study, participants will be offered assistance through the Durham Behavioral Sleep Medicine clinic.
15889983|NCT03727425|Device|Robotic assisted bronchoscopy|Robotic assisted bronchoscopy of peripheral airways in human subjects for the purpose of biopsying peripheral lung lesions.
15889984|NCT03727412|Drug|Drugs, Generic (Naprosyn)|naproxen administration perioperatively in patients with a abdominal aortic aneurysm undergoing endovascular repair
15889985|NCT03727412|Drug|Placebo Oral Tablet|placebo administration perioperatively in patients with a abdominal aortic aneurysm undergoing endovascular repair
15889986|NCT03727399|Other|blood withdrawal|Blood withdrawal
15889987|NCT03727386|Other|Coconut oil|Participants will receive 30 ml of virgin coconut oil to replace their normal oil intake for a period of 6 months.
15889988|NCT03727386|Other|Sunflower oil|Participants will receive 30 ml of sunflower oil to replace their normal oil intake for a period of 6 months.
15889989|NCT03727360|Other|Exercise Training|Supervised exercise conducted four days per week for six months.
15889990|NCT03727360|Other|Flexibility Control|Supervised exercise conducted four days per week for six months.
15889991|NCT03727347|Device|InSeca Stylus|Low power radiofrequency energy delivery to the portion of the nasal cavity mucosa overlying the region of the posterior nasal nerve (the posterior middle meatus and posterior inferior meatus).
15889992|NCT03727334|Behavioral|Online Spatial Navigation Training|Participants complete training tasks that test their spatial navigational abilities, cognitive map formation, and pattern separation. These training tasks involve map drawing, vector mapping, proximity judgments, and navigating with blocked routes.
15889993|NCT03727321|Combination Product|Fecal Microbial Transplant|Fecal microbiome transplant (FMT): 50grams of FMT from a single, universal donor will be administered in 20-30 capsules taken by mouth.
15889994|NCT03727321|Dietary Supplement|Fiber|A combination of soluble corn fiber (PROMITOR®: Tate&Lyle), Resistant Wheat Starch 4 (Fibersym®: MGP Ingredients), and Acacia Gum (Pre-Hydrated Gum Arabic: TIC GUMS) for a total of 6 weeks (men 33g/day; women 27g/day)
15889995|NCT03727321|Dietary Supplement|Cellulose|Placebo will consist of cellulose powder (Microcrystalline cellulose:Blanver) in foil packets.
15889996|NCT03727308|Behavioral|Medical abortion pills sourced from pharmacies|One cohort using medical abortion pills sourced from pharmacies
15889997|NCT03727308|Behavioral|Medical abortion pills sourced from health clinics|One cohort using medical abortion pills sourced from health clinics
15889998|NCT03727295|Drug|Idebenone/placebo|The two control group will be given Idebenone in two different doses，and the placebo group will be given placebo
15889999|NCT03727282|Procedure|adjust dobutamine according to the ejection volume index|adjust dobutamine dose
15890000|NCT03727282|Procedure|adjust dobutamine according to the attending physician|adjust dobutamine dose
15890001|NCT03727269|Other|Wii Fit Training Experimental Group|Experimental group receiving wii fit game based abdomino-pelvic training. A specific protocol was developed by the researchers. Wii fit games which promote exercises focusing on the abdominopelvic cavity strengthening, using as a therapeutic means a Wii™ console with a Wii Fit Plus™ CD game. The protocol was design that which playing games participant perform different pelvic movements such as anteversion, retroversion, lateral tilt and circumduction that maintain trunk control and stabilization with mild abdomino-pelvic muscle activation. Duration of each game is 5 minutes with 90 seconds interval between them twice a week. After performing the sequence of virtual games, a series of abdominopelvic and lower limb muscle stretching exercises will done.
15890002|NCT03727269|Other|Conventional Training|"Control group (n=20) receiving conventional pelvic floor exercises. Conventional exercises includes:
~Knack Maneuver (Ashton -Miller 1998, 2008)
~Pelvic floor strengthening: kegel Exercise.
~-Lumbo-Pelvic Stabilization Exercise.
~Functional Training/ PFM Contraction during ADL
~Correction of biomechanical/structural deformities"
15890003|NCT03727256|Other|ultrasound therapy|Group 1, ultrasound therapy ;1 watt/cm² dose, 1 MHz, 5 minutes
15890004|NCT03727256|Other|neuromuscular electrical stimulation application|Group 2, neuromuscular electrical stimulation application;20 mins/session
15890005|NCT03727230|Other|Blood transfusion|"Transfusion with D+ blood rather than the rare D negative blood to Asia type DEL recipients"
15890006|NCT03727217|Diagnostic Test|Pre and postoperative ultrasound|An ultrasound is performed in preoperative and in postoperative
15890007|NCT03727204|Procedure|On-pump cardiac surgery|All participants will undergo on-pump cardiac surgery
15890008|NCT03727191|Other|Control Group (education, guidelines, recommendations)|Nutritional education and guidelines for the consumption of a completed shreded diet and recommendations for physical activity for one month.
15890009|NCT03727191|Other|Experimental Group (education, guidelines, 2 pckts diet, recommendations)|Nutritional education and guidelines for the consumption of a completed shreded diet including 2 packets of 90 grams every day and recommendations for physical activity for one month.
15890010|NCT03727165|Other|Continuous enteral nutrition infusion|Enteral nutrition administration in continuous infusion during 24 hours per day
15890011|NCT03727165|Other|Cyclic enteral nutrition infusion|Enteral nutrition administration in continuous infusion during 16 hours per day
15890012|NCT03727152|Drug|generic single tablet TAF/FTC/DTG|HIV-infected adults who are virologically suppressed and on protease inhibitor/ritonavir are switched to generic single tablet regimen of tenofovir alafenamide/emtricitibine/dolutegravir
15890013|NCT03727139|Drug|Rasagiline|Rasagiline Tablets
15890014|NCT03727126|Procedure|Robotic esophagectomy|Removal of the esophagus and its draining lymph nodes using robotic surgical instruments
15890015|NCT03727126|Procedure|Thoracolaparoscopic esophagectomy|Removal of the esophagus and its draining lymph nodes using conventional thoracoscopic and laparoscopic techniques
15890016|NCT03727113|Procedure|Optimization cohort|Recipients of an allogeneic hemopoietic stem cell transplant in Centers using an optimization/antibiotic strategy.
15890017|NCT03727113|Procedure|Control cohort|Recipients of an allogeneic hemopoietic stem cell transplant in Centers using a classical strategy of administration of antibiotics.
15890033|NCT03727048|Drug|Ketorolac|the investigators aimed to evaluate the effect of postoperative ketorolac after ankle fracture surgery on postoperative opioid consumption, pain control, an patient satisfaction.
15890034|NCT03727048|Other|No ketorolac|standard of care post operative pain management protocol
15890035|NCT03727022|Drug|Placebo|Healthcare professional-administered intra-articular injections; first performed on Day 1 and second at Week 24. (In the extension phase, healthcare professional-administered intra-articular injections; first performed at Week 52 and second at Week 76.)
15890036|NCT03727022|Drug|SM04690|Healthcare professional-administered intra-articular injections; first performed on Day 1 and second at Week 24. (In the extension phase, healthcare professional-administered intra-articular injections; first performed at Week 52 and second at Week 76.)
15890037|NCT03727009|Other|Blood Sample Collection|Subjects participating in the study will have blood drawn at enrollment.
15890038|NCT03726996|Drug|Desipramine|Study drug (desipramine) provided in tablet form to be taken daily.
15890039|NCT03726983|Other|Experimental group|Pregnant women who agree to take part will be assigned to a group: experimental group and control group. The experimental group will received health management support and counseling that were conducted by the researchers through the e-health management platform.
15890040|NCT03726970|Radiation|CBCT radiation|CBCT scanning
15890041|NCT03726957|Behavioral|Improved Cookstoves|Villages were randomized to have participating households assigned to either a traditional biomass burning cookstove or to an improved cookstove. Once the participating villages had been selected, the investigators used their list of eligible households within each village to randomly order these households. Within each village, the investigators then approached the eligible households in the order that had been randomly chosen and continued that process until four households within each village had agreed to participate. The selection of villages and households preceded randomization and was pursued with the clear understanding that group assignment would be random, and that participation reflected a willingness to be randomized to either study group.
15890042|NCT03726944|Behavioral|Calm App Meditation|The Calm app intervention consisted of 10 min/day of meditation for 4 weeks via the Calm smartphone app.
15890043|NCT03726944|Behavioral|Unnamed Consumer-Based App Meditation|The unnamed consumer-based app intervention consisted of 10 min/day of meditation for 4 weeks via an unnamed consumer-based meditation smartphone app.
15890044|NCT03726944|Other|Educational Control|The educational control consisted of an educational handout that was provided to participants. This control lasted for 4 weeks.
15890045|NCT03726931|Diagnostic Test|18F-Fluorestradiol PET/CT scan|[18F]FES PET/CT scan will be performed after administration of radioactive labelled estrogen.
15890046|NCT03726918|Procedure|Surgery for implantation of a prosthesis|Analysis of micro Ribo Nucleic Acid (RNA) expressed by the synoviocytes, osteoblasts and chondrocytes
15890047|NCT03726905|Other|respiratory muscles training|4 weeks respiratory muscles training aimed on respiratory muscles endurance and lengthening expiration time
15890048|NCT03726905|Other|sham respiratory muscles training|4 weeks sham respiratory muscles training with the help of breathing simulators, with a breathing resistance level set at 0
15890049|NCT03726905|Other|aerobic training|12 weeks treadmill walking
15890050|NCT03726892|Device|PCI|Coronary Intervention
15890051|NCT03726879|Drug|Atezolizumab|Atezolizumab will be administered as per the schedule specified in the respective arm.
15890052|NCT03726879|Drug|Placebo|Placebo matched to atezolizumab will be administered as per the schedule specified in the respective arm.
15890053|NCT03726879|Drug|Doxorubicin|Doxorubicin will be administered as per the schedule specified in the respective arm.
15890054|NCT03726879|Drug|Cyclophosphamide|Cyclophosphamide will be administered as per the schedule specified in the respective arm.
15890055|NCT03726879|Drug|Paclitaxel|Paclitaxel will be administered as per the schedule specified in the respective arm.
15890056|NCT03726879|Drug|Trastuzumab|Trastuzumab will be administered as per the schedule specified in the respective arm.
15890057|NCT03726879|Drug|Pertuzumab|Pertuzumab will be administered as per the schedule specified in the respective arm.
15890058|NCT03726879|Drug|Trastuzumab Emtansine|Participants without pCR have the option of receiving adjuvant atezolizumab/placebo combined with Trastuzumab Emtansine 3.6 mg/kg IV Q3W.
15890059|NCT03726866|Drug|Sequence 1|D326, D337 or CKD-828 for 9 days
15890060|NCT03726866|Drug|Sequence 2|D326, D337 or CKD-828 for 9 days
15890061|NCT03726866|Drug|Sequence 3|D326, D337 or CKD-828 for 9 days
15890062|NCT03726866|Drug|Sequence 4|D326, D337 or CKD-828 for 9 days
15890063|NCT03726866|Drug|Sequence 5|D326, D337 or CKD-828 for 9 days
15890064|NCT03726866|Drug|Sequence 6|D326, D337 or CKD-828 for 9 days
15890065|NCT03726853|Drug|CKD-497 200mg|CKD-497 200mg
15890066|NCT03726853|Drug|CKD-497 300mg|CKD-497 300mg
15890067|NCT03726853|Drug|CKD-497 placebo|Placebo of CKD-497
15890068|NCT03726853|Drug|Comparator|Comparator
15890069|NCT03726853|Drug|Comparator placebo|Comparator placebo
15890070|NCT03726840|Other|Fragrance|peppermint, rosemary, and zest/pulp will increase memory recall for navigation and improve reaction times for braking, compared to performance during unscented conditions
15890071|NCT03726827|Other|Fibroscan screening|A single Fibroscan screening for fat content and liver stiffness
15890072|NCT03726814|Biological|EPC treatment group|Brain injection EPC
15890073|NCT03726801|Other|HEALTH EDUCATION|"The nursing intervention prior to surgery: (breast and colon cancer):
~First phase: At first these subjects suffered a great emotional impact after knowing the diagnosis, which could generate intense anxiety reactions.
~Second phase or phase of coping, in which they begin to be aware of their illness and the future changes they will suffer in their body. In this phase they react with fear, anger, anger, denial, ...
~Third phase or phase of adaptation to the new situation, where there is a decrease in previous emotional reactions, the patient being able to start up the resources learned to reduce their psychological discomfort."
15890074|NCT03726788|Drug|Botulinum Toxin Type A 100U|one intra-articular injection of 100 U of botulinum toxin type A, diluted in 2 ml of 0.9% SSI
15890075|NCT03726788|Drug|Botulinum Toxin Type A 200U|one intra-articular injection of 200 U of botulinum toxin type A, diluted in 4 ml of 0.9% SSI
15891003|NCT03719443|Biological|Placebo|Singe IV dose of placebo administered via IV on Day 1 of study
15890076|NCT03726788|Drug|Triamcinolone Hexacetonide Inj Susp 20 MG/ML|one intra-articular injection of 2 ml Triamcinolone Hexacetonide
15890077|NCT03726775|Drug|Durvalumab|Infusion of durvalumab during RT and after RT during 6 months
15890078|NCT03726762|Behavioral|DBs at the end of the main meal + weight control program|Subjects are asked to have 250 ml DBs at the end of their lunch as the main meal, while they are on a multidisciplinary diet plan.
15890079|NCT03726762|Behavioral|Water at the end of the main meal+ weight control program|Subjects are asked to have 250 ml water at the end of their lunch as the main meal, while they are on a multidisciplinary diet plan.
15890080|NCT03726749|Drug|Tocilizumab|Tocilizumab is an interleukin-6 (IL-6) receptor inhibitor
15890081|NCT03726749|Drug|Prednisone|Prednisone is an anti-inflammatory medication
15890082|NCT03726736|Drug|Anlotinib combined Docetaxel|Anlotinib ( dose base on phase I study, QD PO d1-14, 21 days per cycle) and Docetaxel (60mg/m2 IV, d1, 21 days per cycle)
15890083|NCT03726736|Drug|Docetaxel|Docetaxel (60mg/m2 IV, d1, 21 days per cycle)
15890084|NCT03726710|Behavioral|Blood Pressure measurement and pharmacy|Blood Pressure monitoring by barber, Blood pressure measurement and management by pharmacist in person and through telemedicine
15890085|NCT03726697|Other|Tahneek|A single dose of soft date containing glucose equivalent to 200mg/kg at 1 h after birth will be massaged into the buccal mucosa of the palate and cheek from right to left side, until the date paste is fully absorbed
15890086|NCT03726684|Device|Coding strategy for cochlear implants|Comparison of two variations of a coding strategy based on electrophysiological objective measures with standard reference coding strategy
15890087|NCT03726671|Other|25% Cho diet|Subjects will consume meals containing 25% of recommended intake of Choline for 2 weeks. On day 12 of the diet period, subjects will consume 250 mg of Cho in the form of Cho chloride-(trimethyl-d9, 9%, Cambridge Isotope Laboratories, Tewksbury, Massachusetts, (USA), as a bolus
15890088|NCT03726671|Other|50% Cho diet|Subjects will consume meals containing 50% of recommended intake of Choline for 2 weeks. On day 12 of the diet period, subjects will consume 250 mg of Cho in the form of Cho chloride-(trimethyl-d9, 9%, Cambridge Isotope Laboratories, Tewksbury, Massachusetts, (USA), as a bolus
15890089|NCT03726671|Other|100% Cho diet|Subjects will consume meals containing 100% of recommended intake of Choline for 2 weeks. On day 12 of the diet period, subjects will consume 250 mg of Cho in the form of Cho chloride-(trimethyl-d9, 9%, Cambridge Isotope Laboratories, Tewksbury, Massachusetts, (USA), as a bolus
15890090|NCT03726658|Drug|AGN-241751|AGN-241751 is supplied in tablet form
15890091|NCT03726658|Drug|Placebo|Placebo is supplied in tablet form
15890092|NCT03726645|Other|Fecal microbiota transplantation|Fecal microbiota transplantation
15890093|NCT03726619|Behavioral|e-CHEC-uP|One time online-based education about breast and cervical cancer screening procedures followed by phone counseling by trained community health worker over 6 months
15890094|NCT03726619|Behavioral|CHEC-uP|One time face-to-face education about breast and cervical cancer screening procedures followed by phone counseling by trained community health worker over 6 months
15890095|NCT03726606|Device|Intraocular lens|Bilateral implantation of the same intraocular lens.
15890096|NCT03726593|Drug|Artesunate and Pyronaridine|Standard weight based dosing
15890097|NCT03726593|Drug|Atovaquone Proguanil and Artesunate Pyronaridine|Both drugs (AP) and (ASPY) are administered once a day, on days 0, 1, and 2.
15890098|NCT03726593|Drug|Atovaquone Proguanil and Artesunate Mefloquine|Sequential treatment with ASMQ (on days 0, 1, and 2) followed by the treatment with AP for 3 more days (total 6 days treatment)
15890099|NCT03726580|Drug|Sevoflurane|Assess the effect of isoflurane, sevoflurane, propofol and regional anesthesia on the olfactory threshold, olfactory identification and endocrine regulation of associative memory in the postoperative period in old age group.
15890100|NCT03726567|Procedure|Bariatric surgery|Roux-en-Y surgery
15890101|NCT03726554|Device|Comprehensive Reverse Porous Augmented Glenoid|Three glenoid baseplate options designed for various severities of glenoid erosion and deformity, the device promotes bony ingrowth while restoring natural human anatomy.
15890102|NCT03726554|Device|Comprehensive Mini Humeral Tray|The mini humeral tray offers additional sizing options to the Comprehensive Shoulder line. The mini tray is designed to fit smaller anatomies.
15890103|NCT03726541|Other|physiotherapy|Physiotherapy program includes breathing exercises, incisive spirometer study, grade ambulation. Oxygen saturation, heart rate and blood pressure values will be recorded before and after the session. Changes in the follow-up parameters will be discussed.
15890104|NCT03726528|Diagnostic Test|Measurements of left ventricular pressure and volume|Patients with suspected Takotsubo syndrome (typical ballooning in left ventriculography without significant obstructive coronary artery disease that sufficiently explains the contraction abnormalities) will undergo continuous online measurements of left ventricular pressure and volume using conductance catheters. Cardiac magnetic resonance (CMR) imaging will be performed in patients without contraindications for optimized morphological characterization and exclusion of important differential diagnoses.
15890105|NCT03726515|Biological|CART-EGFRvIII T cells|autologous T cells that have been engineered to express an extracellular Humanized single chain antibody (scFv) with specificity for EGFRvIII linked to an intracellular signaling molecule comprised of a tandem signaling domain of the 4-1BB and TCRζ signaling modules.
15890106|NCT03726515|Biological|Pembrolizumab|humanized monoclonal immunoglobulin (Ig) G4 antibody directed against human cell surface receptor PD-1 (programmed death-1 or programmed cell death-1) with potential immune checkpoint inhibitory and antineoplastic activities.
15890107|NCT03726502|Procedure|ureteroscopy with safety guide-wire|ureteroscopy with use of safety guide-wire in treatment of ureteral stone
15890108|NCT03726502|Procedure|ureteroscopy alone|ureteroscopy without use of safety guide-wire in treatment of ureteral stone
15890109|NCT03726502|Procedure|without safety guide-wire|ureteroscopy without use of safety guide-wire in treatment of ureteral stone
15890110|NCT03726502|Procedure|with safety guide-wire|ureteroscopy with use of safety guide-wire in treatment of ureteral stone
15890142|NCT03726294|Drug|NBM-BMX softgel capsules|Patients will initially receive NBM-BMX orally once a day at 100 mg per day.
15890143|NCT03726281|Drug|Nivolumab|Nivolumab 240 mg, IV
15890235|NCT03725527|Procedure|Rectus Sheath Catheter Block|Sonar guided RSC will be performed using a 16-G, 8-cm TuohyUpon reaching this potential space, after careful aspiration.
15890111|NCT03726489|Device|Daavlin 7 series 3 panel narrow band phototherapy home units|"Daavlin 7 series 3 panel narrow band phototherapy home units (with 8-12 bulbs and a smaller, flat surface with door, measuring 21 wide, 74.5 tall, and 23.5). This unit is a class II device with a FDA 510K indication for psoriasis, vitiligo and atopic dermatitis/eczema. The unit will have a dosimetry controller, a UV sensor built in that measures the intensity of the light. This sensor will adjust the treatment time to compensate for any variation in output due to aging of the lamps or other factors"
15890112|NCT03726489|Device|narrow band phototherapy clinic units|Office based narrow band phototherapy unit (units typically have at least 24 bulbs in a surround structure
15890113|NCT03726476|Behavioral|Patient centered pre-op education|To implement a patient centered education intervention to evaluate post-op narcotic use.
15890114|NCT03726476|Behavioral|routine preop education|To implement routine patient education intervention to evaluate post-op narcotic use.
15890115|NCT03726463|Procedure|Kidney transplantation|Bilateral nephrectomy of polycystic kidneys are routinely performed during kidney transplantation in ADPKD patients
15890116|NCT03726450|Dietary Supplement|Andrositol Plus|Myo-inositol
15890117|NCT03726450|Dietary Supplement|Andrositol Plus|N-Acetyl-Cysteine
15890118|NCT03726450|Dietary Supplement|Andrositol Plus|Folic Acid
15890119|NCT03726450|Dietary Supplement|Andrositol Plus|Selenium
15890120|NCT03726450|Dietary Supplement|Andrositol Plus|L-arginine
15890121|NCT03726450|Dietary Supplement|Andrositol Plus|L-carnitine
15890122|NCT03726450|Dietary Supplement|Andrositol Plus|Vitamin E
15890123|NCT03726437|Behavioral|RealConsent|"This 3-hour web-based program consists of four 45-minute modules that are interactive and range in number of segments (1-14) and types of activities. Each of the modules involves interactivity, didactic activities and two episodes of a serial drama (Squad), which allow for the modeling of positive behaviors and illustrate both positive and negative outcome expectations. Behaviors modeled include drinking safely (e.g., eating before drinking, pacing, and drinking water), having a game plan before going out, communicating with male sex partners, engaging in protective dating behaviors, use of resistance strategies, self-defense strategies and bystander intervention with the goal of reducing risk of being sexually assaulted."
15890124|NCT03726437|Behavioral|Stress and Mood Management|"This 3-hour general health promotion web-based program consists of four 45-minute modules (Stress Management, Managing Depression, Managing Anxiety, and Treatments that work) that provide a range of activities related to reducing day-to day stress and alleviating anxiety through meditation and exercise."
15890125|NCT03726411|Procedure|non-surgical periodontal therapy|scaling and root planing
15890126|NCT03726398|Drug|Opsumit 10 Mg Tablet|Oral tablet taken once daily
15890127|NCT03726372|Drug|Rocuronium|rocuronium is a neuromuscular blocking agent with a duration of 40 minutes
15890128|NCT03726372|Other|continuous infusion|rocuronium is continuously infused
15890129|NCT03726372|Other|intermittent injection|rocuronium is intermittently given
15890130|NCT03726359|Radiation|Fractionated Stereotactic Radiation Therapy|Initial starting dose will be 7 Gy x5= 35 Gy delivered to the planning target volume (PTV). Radiotherapy will be delivered every other day so that the SBRT schedule is completed within 1.5-2 weeks.
15890131|NCT03726346|Device|Toffee Full Face Mask|Participants will be placed on this arm for a total of 14+- 4 days from visit 2. Participants will be using the Toffee mask during this treatment arm.
15890132|NCT03726333|Drug|lorlatinib|continued daily administration of 100 mg lorlatinib
15890133|NCT03726333|Drug|lorlatinib|continued daily administration of lorlatinib at the dose level same as Group C for the first 22 days and 100 mg QD afterwards
15890134|NCT03726333|Drug|lorlatinib|continued daily administration of 100 mg QD lorlatinib
15890135|NCT03726333|Drug|lorlatinib|continued daily administration of lorlatinib at 50 mg QD initially and may be adjusted based on PK and safety results from the initial several patients
15890136|NCT03726333|Drug|lorlatinib|continued daily administration of lorlatinib at the dose level determined based on preliminary PK and safety results from first several patients in Group C
15890137|NCT03726320|Behavioral|Education Counseling Session for PSA Screening|counseling from extensively trained CHW
15890138|NCT03726320|Behavioral|General Health Counseling Coaching|coaching using an educational tool focused on dietary and lifestyle modification
15890139|NCT03726307|Biological|DCreg: 0.5 million cells/kg+SOC|"DCreg 0.5 (±0.1) million cells/kilogram body weight infused as a single dose.
~Standard of Care (SOC) immunosuppressive agents (ISA): Participants will receive combination ISA according to the site's SOC regimen, with two exceptions:
~mycophenolic acid (MPA) will be initiated 7 days before transplant, at the time of donor DCreg infusion, instead of on the day of transplant; and
~the pre-transplant dose of MPA will be half the standard post-transplant dose due to increased drug bioavailability in recipients with low glomerular filtration rate (GFR).
~Participants will be maintained on triple IS therapy with MPA, tacrolimus, and prednisone after transplant, a combination regimen widely applied as SOC at many transplant centers in North America and worldwide."
15890140|NCT03726307|Biological|DCreg: 1.2 million cells/kg+SOC|"DCreg 1.2 (±02) million cells/kilogram body weight infused as a single dose.
~Standard of Care (SOC) immunosuppressive agents (ISA): Participants will receive combination ISA according to the site's SOC regimen, with two exceptions:
~mycophenolic acid (MPA) will be initiated 7 days before transplant, at the time of donor DCreg infusion, instead of on the day of transplant; and
~the pre-transplant dose of MPA will be half the standard post-transplant dose due to increased drug bioavailability in recipients with low glomerular filtration rate (GFR).
~Participants will be maintained on triple IS therapy with MPA, tacrolimus, and prednisone after transplant, a combination regimen widely applied as SOC at many transplant centers in North America and worldwide."
15890141|NCT03726307|Biological|DCreg:2.5 to 5.0 million cells/kg+SOC|"DCreg 2.5 to 5.0 million cells/kilogram body weight infused as a single dose.
~Standard of Care (SOC) immunosuppressive agents (ISA): Participants will receive combination ISA according to the site's SOC regimen, with two exceptions:
~mycophenolic acid (MPA) will be initiated 7 days before transplant, at the time of donor DCreg infusion, instead of on the day of transplant; and
~the pre-transplant dose of MPA will be half the standard post-transplant dose due to increased drug bioavailability in recipients with low glomerular filtration rate (GFR).
~Participants will be maintained on triple IS therapy with MPA, tacrolimus, and prednisone after transplant, a combination regimen widely applied as SOC at many transplant centers in North America and worldwide."
15890144|NCT03726268|Drug|Methadone|"Dose is 0.15-0.3 mg/kg IV methadone HCl given intraoperatively and in the immediate post-operative period. Intraoperative methadone doses are 15 mg in short-stay, anticipated next-day discharge patients (10 mg if ≤55kg), and 10 mg in same-day surgery patients."
15890145|NCT03726268|Drug|Fentanyl|Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).
15890146|NCT03726268|Drug|Hydromorphone|Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).
15890147|NCT03726268|Drug|Morphine|Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).
15890148|NCT03726268|Drug|Sufentanil|Given per clinical provider discretion intraoperatively and in the immediate post-operative period (while patient remains in the post anesthesia care unit (PACU)).
15890149|NCT03726255|Procedure|Mesenchymal Stem Cell injection|curettage, closure of the internal opening (IO) and cell injection in IO (50%) and fistula tract (50%)
15890150|NCT03726242|Drug|Levcromakalim|To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection.
15890151|NCT03726242|Drug|Saline|To investigate the role of levcromakalim compared with placebo after intradermal and intramuscular injection.
15890152|NCT03726229|Device|Cholate assay|Labeled oral and IV cholate will be administered once to the Fontan cohort and blood specimens will be collected at baseline and timepoints thereafter.
15890153|NCT03726216|Drug|Xydalba|Information will be recorded about Xydalba administration (e.g. dose(s), number of infusions, length of infusions, dates or schedule of administration, sites of administration [e.g. hospital, ICU]), and reason for discontinuation, including response to treatment to assess whether the patient was clinically improving when Xydalba was discontinued
15890154|NCT03726203|Device|laparoscopic gynecologic surgery with the MiniLap System.|Subjects participating in the study will undergo laparoscopic gynecologic surgery as planned in the routine care, but using the MiniLap System instead of the conventional single-use trocars used usually.
15890155|NCT03726203|Device|laparoscopic gynecologic surgery with the conventional single-use trocars.|Subjects participating in the study will undergo laparoscopic gynecologic surgery as planned in the routine care using the conventional single-use trocars used usually.
15890156|NCT03726190|Procedure|Oblique Lateral Lumbar Fusion|Oblique lateral lumbar interbody fusion (OLLIF) is a lumbar spinal fusion. OLLIF is performed with the patient in the prone position and employs an oblique lateral approach that enables the instrumentation to pass through Kambin's triangle which is defined as the space between the exiting nerve, the superior border of the caudal vertebra, and the superior articulating process of the inferior facet. This approach may be performed without direct visualization, guided by electrophysiological monitoring and biplanar fluoroscopy. During the approach, a blunt probe is used to make contact with the disc, followed by a series of gentle dilations. Discectomy is performed through a 10-mm access portal. The cage is inserted under continued electrophysiological monitoring and fluoroscopy.
15890157|NCT03726177|Drug|aspirin 162 mg|Aspirin 81mg two tablet once a day from recruitment until 37 weeks or labor whichever comes first
15890158|NCT03726177|Drug|aspirin 81 mg|Aspirin 81mg one tablet once a day from recruitment until 37 weeks or labor whichever comes first
15890159|NCT03726177|Drug|placebo|placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first
15890160|NCT03726164|Device|Remote Conditioning|A Blood pressure cuff will be placed on the arm and inflated to 200mm hg for 5 minutes, and then deflated for 5 minutes, a cycle repeated 3 times.
15890161|NCT03726164|Device|Sham protocol|An un-inflated blood pressure cuff will be placed on the arm for 20 minutes.
15890162|NCT03726151|Behavioral|Parent Reminders|Automated, system-generated mailed or text message reminders
15890163|NCT03726151|Behavioral|Multicomponent clinic-system strategies|"Workflow modifications to reduce missed opportunities for vaccination
~Provider- and clinic-level audit and feedback
~Provider & staff training on workflow modifications and communication strategies"
15890164|NCT03726151|Behavioral|Combined Condition|Parent reminders and multicomponent clinic-system strategies
15890165|NCT03726125|Drug|LY3374849 - SC|Administered SC
15890166|NCT03726125|Drug|Insulin Degludec - SC|Administered SC
15890167|NCT03726125|Drug|LY3374849 - IV|Administered IV
15890168|NCT03726125|Drug|Insulin Degludec - IV|Administered IV
15890169|NCT03726112|Device|SpotOn Specs|SpotOn Balance glasses consists of unique visual stimuli (SpotOn's Neuro Balance Active Spots) applied to specific zones in the peripheral visual field
15890170|NCT03726112|Device|Sham Specs|Sham device
15890171|NCT03726099|Drug|esomeprazole, amoxicillin, furazolidone，tetracycline|Patients will go through a gastroscopy and antimicrobial susceptibility test. Liver and kidney function will be monitored by blood test before and after the treatment. Then, patients will receive a 14-day concomitant therapy containing esomeprazole 40mg bid, amoxicillin 1000mg bid , furazolidone 100mg bid and tetracycline 500mg qid.
15890172|NCT03726086|Diagnostic Test|laryngoscopy|A flexible camera (fiberoptic endoscope) is placed in the patient's nose to view the nose, throat, and airway.
15890173|NCT03726073|Device|Transcutaneous acupoint electrical acupoint stimulation(TEAS) and auricular acupressure|Bilaterally Hegu (LI4), Neiguan (PC6) and Zusanli (ST36) will be used as the TEAS acupoints. Six acupoints (Shenmen, Point Zero, subcortex, heart, liver, and endocrine) located on ears will be used as the auricular acupressure points.
15890174|NCT03726073|Other|Usual care|Patients in this group only receive usual care developed by the study hospital
15890175|NCT03726060|Other|control group|In the control group the patient will undergo gnathologic therapy for 6 months with neuromuscural splint every night for 3 months
15890176|NCT03726060|Other|test group|In the test group the patient will undergo gnathologic therapy with neuromuscural splint every night for 3 months in association with physical therapy
15890177|NCT03726047|Behavioral|Exercise|Subjects will complete 5 minutes of exercise on an ergometer to examine the effects of exercise on retention of a newly learned walking pattern.
15890232|NCT03725553|Drug|Placebo|the group received a 10-mL bolus injection of saline into the myometrium during slow (30-seconds)as soon as the umbilical cord was clamped.
15891081|NCT03718962|Device|Surrounding needling+ phototherapy|Surrounding needling+ phototherapy
15890178|NCT03726034|Behavioral|Life Story Book|The protocol of life story book creation is validated in Hong Kong. The life story book would contain two elements: (1) the development of the older adults over the course of his/her lifetime (i.e. from childhood to old age); and (2) the psychosocial development and ways of life of the older adults (e.g. education, marriage, career, and hobbies). The product of the intervention will be a written story with pictures or other memorabilia that are meaningful to the older adults. There is no limitation on the number of words, pages, and pictures. Four to six 60-minute scheduled sessions will be needed for the older adult and the live-in migrant caregivers to discuss and produce the lifestory book at home.
15890179|NCT03726034|Behavioral|Self-selected social activities|To control the possible social interaction effects on the dyadic relationship and wellbeing, the caregivers of the control group will conduct self-selected social activities with older adult at home individually for four times weekly.
15890180|NCT03726021|Drug|Irinotecan,Oxaliplatin, and S1|"Drug: Irinotecan is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.
~Drug: Oxalipatin Oxaliplatin is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells
~Drug: S1 is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells"
15890181|NCT03726008|Behavioral|Perinatal health promotion program and regular prenatal care|Regular prenatal care and perinatal health promotion program including health promotion during pregnant period, health promotion during the ritual of Tso-Yueh-Tzu, health promotion during postpartum period, newborn care
15890182|NCT03725995|Drug|Midazolam|Patients received 0.5 mg/kg midazolam, with a maximum dose of 10 mg, Immediately following the administration, the child was asked to record the score of pain on the self reporting pain scale, WBFS.
15890183|NCT03725995|Drug|Lidocaine-Midazolam|Patients received a puff of lidocaine 2% in each nostril, after 60 seconds, they received 0.5 mg/kg midazolam, with a maximum dose of 10 mg. , Immediately following the administration, the child was asked to record the score of pain on the self reporting pain scale, WBFS.
15890184|NCT03725995|Drug|Placebo|Patients received saline 9% (placebo), 0.5 mg/kg, with a maximum dose of 10 mg, Immediately following the administration, the child was asked to record the score of pain on the self reporting pain scale, WBFS.
15890185|NCT03725982|Device|Laevo ®|A passive exoskeleton supporting the lower back during bending and lifting tasks (for more information, visit the manufacturer's website: http://en.laevo.nl/).
15890186|NCT03725982|Device|No Laevo ®|The subjects will not wear any supporting device to perform the experiment, which serves as the control condition.
15890187|NCT03725969|Dietary Supplement|Camel milk|Camel Milk administered 10 minutes before a mixed meal of carbohydrate and protein; 2-week washout between interventions
15890188|NCT03725969|Dietary Supplement|Cow milk|Cow milk administered 10 minutes before a mixed meal of carbohydrate and protein;2-week washout between interventions
15890189|NCT03725956|Procedure|Endoscopic sinus surgery|"Surgical procedure under general anaesthesia:
~Consists of the removal of bone boundaries between sinus cavities (ethmoidectomy) with nasal polyps resection in order to retrieve nasal patency and sinus drainage Polysomnographic assessment as routinely applied in clinical practice"
15890190|NCT03725943|Diagnostic Test|Dreem|Dreem Band to be worn by each participant while undergoing in-lab sleep study with PSG.
15890191|NCT03725930|Drug|Clonidine|clonidine intranasal premedication in preschool infants
15890192|NCT03725930|Other|Placebo|Placebo intranasal premedication
15890193|NCT03725917|Other|Physiotherapy protocol|The intervention will consist of a physiotherapy protocol twice a week for twelve weeks. The protocol will be done in three phases, constituting each month, a phase of the protocol. The first two phases will include therapeutic exercise of progressive difficulty and manual therapy, while the last phase will include only one week of manual therapy and therapeutic exercise, the last three weeks being composed only of therapeutic exercise
15890194|NCT03725904|Diagnostic Test|Progesterone analysis in saliva|Analysis of salava progesterone
15890195|NCT03725891|Drug|Aspirin 162 mg|Aspirin 81mg two tablet once a day from recruitment until 37 weeks or labor whichever comes first
15890196|NCT03725891|Drug|Aspirin 81 mg|placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first
15890197|NCT03725891|Drug|placebo|placebo one tablet once a day from recruitment until 37 weeks or labor whichever comes first
15890198|NCT03725878|Procedure|Standard tertiary interventions of birth defects|Couples eligible for reproductive policy are entitled to routine health cares including general health cares (health education, medical history inquiry, physical examinations, consulting guidance and pregnancy outcome follow-up) and medical examinations (laboratory examinations, virus screenings and image examinations). But nutrients status are not included in these examinations, such as folate, vitamin B12, and macroelements, et al. Regular antenatal cares are required, such as deformity screening by ultrasound. Routine neonatal screenings are conducted to diagnose infant with birth defect timely.
15890199|NCT03725878|Procedure|Additional preconception health care|Various studies have revealed that folate is essential in early embryo development, whereas folate level evaluation in periconception women is not included in routine health cares. Therefore, we evaluate subject's folate level by serum and red blood cell folate examination. By combination of folate supplement obtained by questionnaire,folate level evaluated by examinations and folate metabolism ability evaluated by genotyping key enzymes in folate metabolism, an individualized folic acid supplementary guide is given to subjects. Red blood cell folate concentration >400 ng/ml before pregnancy is recommended.
15890200|NCT03725878|Procedure|Additional health care procedures during and after pregnancy|Fetus with birth defect will be referred to a tertiary hospital to receive genetic assessments and prenatal diagnosis to reduce unnecessary abortions. A 6-months follow up will be conducted to follow children's birth outcomes. It also helps clinical team to give early diagnosis and treatment for children with birth defect to reduce disability and improve life quality of defect children.
15890201|NCT03725865|Biological|Induction of neural stem cells|Brain injection iNSC
15890202|NCT03725852|Drug|GLPG1205|GLPG1205 will be provided as an oral hard gelatin capsule.
15890203|NCT03725852|Drug|Placebo|GLPG1205 matching placebo will be provided as an oral hard gelatin capsule.
15890204|NCT03725839|Device|F&P Interface|F&P Interface to be used for OSA therapy
15890233|NCT03725540|Device|I-gel|Patients will be anesthetized using an appropriate sized I-gel mask according to the manufacturer's recommendations after lubrication with a water-soluble lubricant.
15891082|NCT03718962|Device|phototherapy|phototherapy
15890205|NCT03725813|Other|Person-centred inpatient care|"The intervention comprises three sequential steps in the care process. The first two steps follow one after the other in conjunction with admission to the ward: 1) person-centred assessment, and 2) creation of a person-centred health plan. Persistent person-centred inpatient care, the third step, is practiced throughout the hospital stay, and is a component of the quality and patient safety program.
~The model is systematically applied to all patients admitted to the unit. All staff are trained in PCC before implementation of the intervention."
15890206|NCT03725787|Device|CuroCell S.A.M. ® pro mattress|During 30 days, participants will use the static air mattress.
15890207|NCT03725774|Other|GRIP (Getting Research into Practice) model|"The intervention will consist of the use of the GRIP (Getting Research into Practice) model and implementation of its strategies in clinical practice, according to the study unit in question and the scope of action.
~The GRIP model is a process of improvement by reference to a prior baseline clinical audit. It implies a local situation analysis, identifying the obstacles to improvements in clinical practice, and drawing up and implementing a plan of action for the purpose of improving adherence to pre-established criteria. The goal is to establish interprofessional processes within the teams, in order to: examine the obstacles that hinder the use of evidence in fostering best practices; and contribute to the development of implementation programmes for overcoming such obstacles."
15890208|NCT03725761|Drug|IMMU-132|IMMU-132 is a novel Antibody Drug Conjugate (ADC) based on a humanized anti-Trop-2 antibody (hRS7) conjugated to SN-38 payload.
15890209|NCT03725748|Other|irrigation|irrigation the edges of the cs scar before closure
15890210|NCT03725735|Behavioral|CBT for problem gambling with emotion regulation|CBT group treatment for problem gambling with emotion regulation focus, with 8 sessions.
15890211|NCT03725722|Drug|Delgocitinib cream|Cream for topical application
15890212|NCT03725722|Drug|Delgocitinib cream vehicle|The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
15890213|NCT03725709|Procedure|spinal anesthesia|Plan to enroll 120 Type 2 diabetes and 120 non-diabetes patients with received spinal anesthesia.Blood will be collected at time point of pre-anesthesia 10 minutes and CSF samples will be collected at time point during spinal anesthesia induction. Blood will be collected, drawn into EDTA-coated tube.
15890214|NCT03725696|Diagnostic Test|Semen Analysis|Sperm counts will be determined by semen analysis.
15890215|NCT03725696|Diagnostic Test|Hormonal panel|Blood test for LH, FSH, testosterone, and estradiol
15890216|NCT03725696|Procedure|RYGB Gastric Bypass|Roux-en-Y Gastric Bypass
15890217|NCT03725696|Diagnostic Test|IIEF Survey|International Index of Erectile Function is a validated 5-question survey examining sexual health in men
15890218|NCT03725683|Device|Increased caliber balloon|"Imaging of target lesions was performed before surgery to evaluate the characteristics of target lesions.
~Postoperative to discharge Laboratory examination: blood routine, renal function, biochemical, coagulation functionTo determine and record the ABI(ankle-brachial pressure index);Records Rutherford classification; record the application of anticoagulant and antiplatelet agents; Records of adverse events."
15890219|NCT03725683|Device|matched caliber balloon|"Imaging of target lesions was performed before surgery to evaluate the characteristics of target lesions.
~Postoperative to discharge Laboratory examination: blood routine, renal function, biochemical, coagulation functionTo determine and record the ABI index;Records Rutherford classification; record the application of anticoagulant and antiplatelet agents; Records of adverse events."
15890220|NCT03725670|Biological|Lentivirus-mediated delivery of ARSA to the CNS.|Intracerebral LV gene therapy to deliver high level lenviral vectors which carry normal ARSA gene at 1-2×10^9 multiplicity of infection (moi)/ml per site.
15890221|NCT03725644|Behavioral|parent-training program|Parents in the treatment group received the training program from the registered pediatric occupational therapist in six hours over three weeks. The occupational therapist provided suggestions and gave feedback. The parents were encouraged to interact with their children for at least 15 hours per week. Between the fourth and 14th weeks, the parents implemented the intervention programs at home and recorded the daily intensity. The occupational therapist met with the parents and children at monthly intervals (the seventh and 11th weeks) at the laboratory to discuss any difficulties they encountered and to practice the child-initiated activities.
15890222|NCT03725644|Behavioral|traditional program|Parents in the control group also conducted a 14-week program. They received six hours of training over three weeks.Between the fourth and 14th weeks, the parents implemented parent-led activities at home and recorded the daily intensity. The parents were encouraged to do activities with their children for at least 15 hours per week. The occupational therapist met with the parents at monthly intervals (the seventh and 11th weeks) at the laboratory to discuss any difficulties they encountered while practicing the parent-led activities.
15890223|NCT03725631|Diagnostic Test|Imaging and serologic evaluation of fibrosis and steatosis|Imaging evaluation: Fibroscan, MRI scan for evaluation of fibrosis and steatosis in biopsy proven NAFLD patients Serologic evaluation: serologic test for evaluation of fibrosis and steatosis in biopsy proven NAFLD patients
15890224|NCT03725618|Biological|Yellow Fever 17DD Vaccine|live attenuated vaccine based on the 17DD strain
15890225|NCT03725605|Combination Product|LTX-315 and TILs|Intratumoural injection of LTX-315 and infusion of TILs
15890226|NCT03725592|Other|Standard Treatment|Participant households receive a point of use arsenic removal device and a replacement filter. Households are also provided with an instruction manual on how to use the device.
15890227|NCT03725592|Behavioral|Intensive Education|Participant households receive up to five additional in-person visits and phone calls to provide support regarding the health implications of arsenic and the proper use and maintenance of the arsenic removal device.
15890228|NCT03725579|Drug|mepivicane hydrochloride|Pain will be assessed during access cavity preparation and instrumentation
15890229|NCT03725579|Drug|articane hydrochloride|Pain will be assessed during access cavity preparation and instrumentation
15890230|NCT03725566|Drug|Experimental|Recombinant humanized anti-VEGF monoclonal antibody injection 0.625mg/1.25mg/2.0mg/2.5mg by intravitreous injection,day 1 in the first month;
15890231|NCT03725553|Drug|Intramyometrial Vasopressin|a bolus injection of vasopressin (4 IU) diluted to 2 mL with saline into the myometrium of the placental bed during slow (30-seconds) immediately after delivery, as soon as the umbilical cord was clamped.
15890234|NCT03725540|Device|Baska_mask|Patients will be anesthetized using BASKA mask after lubrication with a water-soluble lubricant.
15890236|NCT03725527|Procedure|Epidural Catheter Block|Sonar-guided epidurals will be performed with a 17-gauge Tuohy needle and 19 G flex-tip catheter. Using an LOR (loss of resistance) to saline technique, catheters will be inserted 4 cm into the epidural space and a suitable test dose will be administered to exclude intravascular or sub-arachnoid injection.
15890237|NCT03725514|Procedure|Conventional|Conventional Blood Clot Technique
15890238|NCT03725514|Procedure|PRF|Platelet Rich Fibrin Technique
15890239|NCT03725501|Drug|ALS-L1023|ALS-L1023 is an active fraction extracted from Melissa officinalis L. (Labiatae; lemon balm) leaves.
15890240|NCT03725501|Drug|Ranibizumab|LUCENTIS® (an anti-neovascular VEGF-A inhibitor) 0.5 mg, intravitreal injection
15890241|NCT03725501|Other|Placebo|Control group for comparison with oral administration of ALS-L1023
15890242|NCT03725488|Other|Questionnaire|"students were involved in the pre-clinical prosthodontic lab. Participation in these labs were mandatory and it involved crown and bridge preparations on typodont models. There were 2 sessions of these labs per week, one for each gender. Each session lasted for 3 hours.
~The study was conducted in 2 phases. At the beginning of the first phase of the study, the labs were conducted without any BM for 4 weeks. PSS(perceived stress scale), a standardized and validated, self-reporting international test was used for measuring the level of psychological stress were administered to all participants."
15890243|NCT03725462|Device|Cardioskin|Subjects have a monitoring with cardioskin and comparator
15890244|NCT03725462|Device|Neuronaute|Subjects have a monitoring with Neuronaute and comparator
15890245|NCT03725449|Other|Best Practice|Receive standard of care
15890246|NCT03725449|Behavioral|mySmartCheck|Receive access to mySmartcheck program
15890247|NCT03725449|Other|Survey Administration|Ancillary studies
15890248|NCT03725436|Drug|MDM2/MDMX Inhibitor ALRN-6924|Given IV
15890249|NCT03725436|Drug|Paclitaxel|Given IV
15890250|NCT03725423|Drug|Apatinib|250mg, qd once a day, take it half an hour after meal (the time for taking the medicine should be the same as possible), and take it with warm water. 28 days is a drug delivery cycle.
15890251|NCT03725410|Device|Venus Fiore Study Treatment|Study treatment consists of delivering radiofrequency (RF) and pulsed electromagnetic fields (PEMF) internally to the vagina (50 - 70% for up to 15 minutes), externally to the labia (10 - 35% for up to 10 minutes) and externally to the mons pubis (10 - 35% for up to 15 minutes).
15890252|NCT03725410|Device|Venus Fiore Sham Treatment|Sham treatment consists of delivering radiofrequency (RF) and pulsed electromagnetic fields (PEMF) internally to the vagina (1% for up to 15 minutes), externally to the labia (1% for up to 10 minutes) and externally to the mons pubis (1% for up to 15 minutes).
15890253|NCT03725397|Behavioral|Outpatient|The offered (studied) intervention will be allowing the women with a transcervical Foley catheter in place to spend the night at home.
15890254|NCT03725397|Behavioral|Inpatient|"Women with a transcervical Foley catheter to be admitted to the hospital overnight which has been a standard of care."
15890255|NCT03725384|Drug|Ferrous Sulfate 300Mg Tablet|oral dose of Ferrous Sulfate (300 mg) every day versus every other day along with vitamin C
15890256|NCT03725384|Drug|Vitamin C 500Mg tablet|Vitamin C 500 Mg tablet every day versus every other day along with ferrous sulfate
15890257|NCT03725371|Other|No intervention was administered for the purpose of this study.|No intervention was administered for the purpose of this study. Observations were carried out for all participants.
15890258|NCT03725358|Behavioral|Training|Health facilities assigned to this group will receive a two-week training intervention on modern contraceptive methods and counseling techniques - aimed at nurses conducting family planning services. This new curriculum was developed by a large group of experts convened by the Ministry of Health in February 2018. The cascade training that is developed by the national government (cascading down to regions, districts, and finally health facilities) is a 15-day training module that targets family planning nurses, covering theory, practical knowledge (practicing administrations and removals), and counseling of clients.
15890259|NCT03725358|Behavioral|App|"Health facilities assigned to this group will receive the same programming as the facilities in S1, but they will also be provided with tablets equipped with the job aid, which subsumes the basic data collection software used by the remaining facilities. They will also receive additional training on the use of the tablet-based job aid.
~The app is a tablet-based decision-support tool, which is designed for use by the family planning nurse conducting counseling sessions and records the answers to a series of questions that elicit the client's life goals, fertility plans, needs, and preferences regarding contraceptive methods, as well as her medical eligibility (birth history, pregnancy check, breastfeeding status, blood pressure, medications, etc.)."
15890260|NCT03725358|Behavioral|Control|The comparison group includes facilities that continue business as usual (no FP training or tablet-based job aid). Each facility in this group will receive a tablet equipped with basic data collection software and a one-day training to use the tablets.
15890261|NCT03725345|Behavioral|MRI Scanner|Participants will enter the MRI scanner and complete a series of computer tasks that include noise blasts while undergoing brain scans that measure the structure and function of the brain
15890264|NCT03725306|Device|Librata|Hyperthermic endomyometrial treatment via Librata catheter and balloon device
15891207|NCT03717935|Dietary Supplement|Essential Amino Acid (EAA) Supplement|Powder supplement
15890265|NCT03725293|Device|Angiodynamics BioFlo Midline Catheter|Placement of Angiodynamics BioFlo Midline Catheter.
15890266|NCT03725293|Device|Teleflex Arrowg+ard Blue Advanced Midline Catheter|Placement of Teleflex Arrowg+ard Blue Advanced Midline Catheter.
15890267|NCT03725280|Procedure|IVF|None interventional study (Collection of ovarian follicular fluid during IVF treatment)
15890268|NCT03725267|Drug|Melatonin Pill|Patients will receive 1 pill of melatonin each day during polymyxin B therapy for a maximum of 14 days.
15890269|NCT03725267|Drug|Placebo oral capsule|Patients will receive 1 pill of placebo each day during polymyxin B therapy for a maximum of 14 days.
15890270|NCT03725254|Procedure|lymphadenectomy|The retroperitoneal lymphadenectomy includes all lymph, fat, and connective tissue in the retroperitoneal space.
15890271|NCT03725254|Radiation|chemoradiotherapy|Radiation therapy is highly appropriate, based on the characteristics of the lesion and the surrounding critical organs, and select IMRT or stereotactic radiotherapy (SBRT).
15890272|NCT03725241|Dietary Supplement|Glutathione Supplement|1000 mg/day Glutathione
15890273|NCT03725241|Dietary Supplement|Placebo Supplement|Crystalline cellulose
15890274|NCT03725228|Drug|Magnesium Sulfate|Magnesium Sulfate 15mg/kg/h
15890275|NCT03725228|Drug|Lidocaine|Lidocaine 1,5mg/kg/h
15890276|NCT03725215|Behavioral|Split-Belt Treadmill Training|One session of 6 x 5 min with 1 min intervals.
15890280|NCT03725189|Device|PPG during exercise|PPG use for pulse waveform evaluation of healthy exercise group
15890281|NCT03725163|Behavioral|Acceptance and Commitment Therapy Enhanced Behavior Therapy (AEBT)|This treatment approach blends traditional behavior therapy elements of habit reversal training and stimulus control techniques with the more contemporary behavioral elements of Acceptance and Commitment Therapy (ACT). The first phase of the treatment, clients are taught skills for stopping and preventing their unconscious pulling episodes. The second phase, clients are introduced to ACT. Unlike interventions that aim to change the type or frequency of pulling-related cognitions, this treatment uses strategies to change the function of these cognitions. Clients are taught to see urges for what they really are and to accept their pulling-related thoughts, feelings, and urges without fighting against them. Over the course of 10 session clients will learn to be aware of their pulling and warning signals, use self-management strategies for stopping and preventing pulling, stop fighting against their pulling-related urges and thoughts, and work toward increasing their quality of life.
15890282|NCT03725137|Other|Analysis of T-lymphocytes|Analysis of T-lymphocytes regarding the development of cognitive function after stroke
15890283|NCT03725124|Other|Interview|Participants will be interviewed on their experience of family planning and inflammatory bowel disease.
15890284|NCT03725111|Device|venous compression|venous compression
15890285|NCT03725098|Device|HEMOBLAST Bellows|The HEMOBLAST™ Bellows hemostatic agent consists of a bellows pre-loaded with 1.65g of powder composed of collagen, chondroitin sulfate, and thrombin (1500 IU). HEMOBLAST™ Bellows is indicated in surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures.
15890286|NCT03725098|Device|FLOSEAL|The FLOSEAL Matrix consists of a bovine-derived Gelatin Matrix component, a human-derived Thrombin component, applicator tips, and several mixing accessories. FLOSEAL is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or conventional procedures is ineffective or impractical.
15890287|NCT03725085|Drug|Mucinex™ extended-release (SE)|2 tablets of Mucinex™ (GGE, 600 mg extended-release bi-layer tablets)
15890288|NCT03725072|Drug|Evobrutinib|Participants will receive a single, oral dose of evobrutinib under fasting conditions as a solution, which will contain [14C]-evobrutinib.
15890298|NCT03725046|Other|Optimized information transmission|Sending to the community referring physician by the emergency department an discharge report containing the reason for emergency consultations (report currently made as part of the treatment). Within 72 hours (working hours), the Emergency Clinical Pharmacist contacts the referring physician and the patient's community pharmacist to discuss how to manage the ADE. In parallel, a second report, summary of the ADE (ADE-report), is sent to them. The ADE-report, written and validated by the investigators (emergency physician and clinical pharmacist), includes the type of ADE, the suspected drug(s) and other recommendations: therapeutic modification, referral to specialized consultations (geriatrics ...).
15890299|NCT03725033|Drug|Subetta|Oral administration.
15890300|NCT03725033|Drug|Placebo|Oral administration.
15890301|NCT03725020|Other|Fluoride varnish|The study will employ a double-blind, randomized placebo-controlled design with two parallel groups. The intervention will start at onset of the fixed appliances and will be finalized one year after debond. The primary outcome will be incidence of white spot lesions on the labial surfaces of the maxillary incisors, canines and premolars, as assessed from high-resolution digital photos. The secondary outcome is the prevalence of WSLs at debonding.
15890302|NCT03725007|Drug|Upadacitinib|Upadacitinib is administered as an oral solution or tablet as described in protocol.
15890303|NCT03724994|Drug|Gemcitabine|Adjuvant or palliative chemotherapy according to national guidelines
15890304|NCT03724981|Drug|Dulaglutide Pen|Injected on a practice pad.
15890305|NCT03724981|Drug|Semaglutide Pen|Injected on a practice pad.
15890306|NCT03724968|Drug|Nivolumab|Nivolumab will be given by vein on day 1 of each cycle.
15890307|NCT03724968|Drug|Relatlimab|Relatlimab will be given by vein on day 1 of each 28-day cycle
15890308|NCT03724968|Drug|Ipilimumab|Ipilimumab will be given by vein on day 1 during cycles 1-4 (cycles are 21 days).
15890309|NCT03724955|Drug|Estradiol 2 mg|Participants in this arm will receive Estradiol 2 mg oral daily for 6 months
15890310|NCT03724955|Other|Placebo|The placebo group will receive placebo oral daily for 6 months
15890311|NCT03724942|Drug|Brexpiprazole|Brexpiprazole 1mg or 2mg will be orally once daily for 14 weeks
15890312|NCT03724929|Procedure|Blood sample|Blood samples will be systematically collected at W0, W2, W6, W14 and W52 for vedolizumab pharmacokinetic parameters, including the vedolizumab trough levels and the specific anti-vedolizumab antibody. A supplementary blood sample will be collected at W10 which is the point where a significant greater number of patients were in remission.
15890313|NCT03724929|Device|Rectosigmoidoscopy|Rectosigmoidoscopy will be performed in each center at time points W0, W10 and W52.
15890314|NCT03724916|Drug|TAK-079|TAK-079 Subcutaneous injection.
15890315|NCT03724916|Drug|TAK-079 Placebo|TAK-079 placebo-matching subcutaneous injection.
15890316|NCT03724903|Procedure|Ductal lavage|The patients received ductal lavage and breast massage every other day for two weeks. We used lidocaine (1%) for local anesthesia around the nipple. We used a lacrimal probe to identify 4-5 openings in the lactiferous ducts on the nipple and inserted the infusion cannula (21-23G). A total of 25ml of irrigation solution (5 ml of 2% lidocaine, 40 mg of triamcinolone acetonide, 20 ml of 0.9% saline and 1.0 g of ceftriaxone) was pumped into the ducts over 20-25 minutes. The patient returned to the clinic the next day for breast massage, and the cycle was repeated for two weeks.
15890317|NCT03724903|Drug|Corticosteroid therapy|Meprednisone or prednisone 20-40mg, qd for two weeks, then temper the dose gradually, and then 20mg qd for maintenance (The total duration of the treatment is 6 months).
15890318|NCT03724890|Drug|M3814|Participants will receive M3814 twice daily (BID) continuously starting from Day 1 until progressive disease (PD) or unacceptable toxicity.
15890319|NCT03724890|Drug|M3814|Participants will receive M3814 concomitantly with RT once (QD) daily starting Day 1 for 5 days per week for 2 weeks in total.
15890320|NCT03724890|Drug|Avelumab|Participants will receive avelumab once every 2 weeks (Q2W) starting from Day 1 until PD or unacceptable toxicity.
15890321|NCT03724890|Radiation|Radiotherapy|Participants will receive radiotherapy at the dose of 3 grays (Gy) per day starting Day 1 for 5 days per week for 2 weeks.
15890322|NCT03724877|Drug|Long-acting beta2-agonist-long-acting muscarinic antagonists-inhaled corticosteroids(LABA-LAMA-ICS)|(LABA-LAMA-ICS)
15890323|NCT03724877|Drug|Long-acting beta2-agonist-inhaled corticosteroids-long-acting muscarinic antagonists (LABA-LAMA)|(LABA-LAMA)
15890324|NCT03724864|Dietary Supplement|delivery of snacks|Subjects were randomly assigned to three groups (blue, green and yellow), receiving a single type of snack for 42 days. Block randomization ensured similar proportions of participants in each group. All subjects received snack packets (six cookies each) on a weekly basis. Children were instructed to use the snack twice a day, one in the morning and one in the afternoon during lesson breaks. Both participants and investigators were blinded to the treatment assignment.
15890325|NCT03724851|Drug|TEW-7197|TEW-7197 will be administered orally for 5 days per week (5D/W) at the same time in the morning and evening (BID) approximately 12 hours apart.Pembrolizumab will be administered as a dose of 200 mg every 3weeks.
15890326|NCT03724838|Drug|Esomeprazole with Sildenafil Citrate|Patients will take esomeprazole single dose of 40 mg orally once a day
15890327|NCT03724838|Drug|Sildenafil Citrate|Patients will take Sildenafil Citrate 40mg every 8 hours
15890328|NCT03724838|Drug|Placebo to Esomeprazole|Patients will take inert tablets similar in appearance, color, and consistency to esomeprazole single dose of 40 mg orally once a day
15890329|NCT03724838|Drug|Placebo to Sildenafil Citrate|Patients will take inert tablets similar in appearance, color, and consistency to Sildenafil Citrate 40mg every 8 hours
15890330|NCT03724825|Diagnostic Test|lipid profile: Total cholesterol (TC), triglycerides (TG), low density lipoprotein (LDL) and high density lipoprotein (HDL))|blood samples will be collected after 10 hours fasting
15890331|NCT03724825|Diagnostic Test|Total testosterone|blood samples will be collected after 10 hours fasting
15890332|NCT03724825|Diagnostic Test|Adropin|blood samples will be collected after 10 hours fasting
15890333|NCT03724825|Diagnostic Test|Adiponectin|blood samples will be collected after 10 hours fasting
15890334|NCT03724812|Device|Portico Valve and FlexNav™ Delivery System|Subjects will undergo transcatheter aortic valve replacement (TAVR) with the Portico valve and second-generation FlexNav Delivery system via a transfemoral access approach
15890335|NCT03724799|Device|Intravascular laser irradiation of blood for the patients with cerebral infarction|Intravenous low level therapy has been a variety of applications in many different areas of medicine with a growing interest. It possesses laser specific biomodulation, analgesic, spasmolytic and even sedative effects among many other.
15890336|NCT03724786|Diagnostic Test|Six-hour urine protein collection|This intervention includes the analysis of a 6-hour urine collection for protein, to serve for a calculated 24-hour result, according to which pregnancy will be managed.
15890337|NCT03724773|Device|Long-Arm Cast|A long-arm cast is a circumferential wrapping of the arm from the fingers to above the elbow with casting material.
15890338|NCT03724773|Device|Sugar-Tong Splint|A sugar-tong splint is the application of hard splinting material on the front and back of the arm.
15890339|NCT03724760|Other|personalized repeated feedback approach|Feedback on number of steps taken by patint, as recorded by pedometers, provided by research team
15890340|NCT03724747|Drug|BAY2315497 Injection|BAY 2315497 Injection comprises 3 components: the PSMA-specific monoclonal antibody (mAb), the mAb-chelator conjugate, and the thorium-227 labeled mAb-chelator conjugate. BAY 2315497 Injection will be administered on Day 1 of each treatment cycle.
15890341|NCT03724747|Drug|Darolutamide(BAY1841788)|600 mg (2 X 300 mg tablets), twice daily with food, equivalent to a total daily dose of 1200 mg.
15890364|NCT03724526|Behavioral|Text messaging|"Intervention-Text messaging: Participants will receive regular text messages for 12 months. Each participant will receive 6 text messages per week. They will receive one general education about diabetes and CVD messages, one glucose control message, one blood pressure control message, one healthy eating message, one medication adherence message and one physical activity message per week.
~Control: The control group will receive the usual care."
15891208|NCT03717935|Other|Placebo|Powder that will be similar to the essential amino acid supplement
15890342|NCT03724734|Device|Adaptive DBS|We will use our custom-built externalized research system (ERS) to allow recordings and stimulation. The device is small and lightweight and communicates wirelessly with a personal computer. The electrical connections to the DBS leads will be through temporary extensions with appropriate mechanical slack. To allow for stimulation return, a conductive clip to the ERS case will be connected to a conducting (ECG) pad placed over chest. Periodic impedance checks will ensure this connection is robust through the course of the experiment. The patient can be ambulant whilst wearing the device.
15890343|NCT03724734|Device|Conventional DBS|We will use our custom-built externalized research system (ERS) to deliver continuous conventional stimulation.
15890344|NCT03724721|Procedure|vacuum bottle|using vacuum bottle plus catheter for drainage of pneumothorax
15890345|NCT03724708|Device|IUD|IUD insertion
15890346|NCT03724695|Other|Clinician nudge or opt out approach for AHCAH liaison visit|"This study is a nudge or opt-out approach of an AHCAH liaison visit to eligible seriously ill HF patients prior to hospital discharge to discuss the AHCAH program and to subsequently facilitate enrolling them in the AHCAH program if they are amenable, compared to the opt-in approach (usual care)."
15890347|NCT03724682|Device|Carry Life UF device|Treatment with the Carry Life UF device compared to standard PD therapy
15890348|NCT03724669|Behavioral|waiting list|After the study ends, they will have access to receive the educational texts and view the online lectures.
15890349|NCT03724669|Behavioral|benzodiazepines related knowledge intervention|participants receiving 11 articles pushing and 3 online lectures through the electronic interventions App, once a week, last for 3 months
15890350|NCT03724656|Device|acupuncture treatment|"TAES treatment 30 minutes before induction of anesthesia. Bilateral Neiguan（PC6）, bilateral Zusanli（ST36）and bilateral Hegu （LI4）point were selected by electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China).After Deqi, electroacupuncture stimulation apparatus is connected and maintained until the end of operation."
15890351|NCT03724656|Device|sham acupuncture treatment|"Participants in the sham acupuncture group received shallow needling (0.30mm×25mm) at bilateral sham points(nonacupoints located 5cm beside acupoints, about 20mm). The control group was treated with non-acupoint shallow acupuncture method and the needling depth was less than 2 mm. At the same time, the manual stimulation and Deqi was avoided."
15890352|NCT03724643|Other|Protocolized wean|Respiratory therapist determined extubation readiness based on: patent and protected airway; adequate secretion clearance; suction requirement ≤ every 2 hours; FiO2 < 50% and PEEP = 5; and hemodynamic stability without circulatory support. The SBT included CPAP = 5 mmHg at FiO2 ≤ 0.4. Patients were assessed after 3-minutes for appropriateness to continue (SaO2 ≥ 92%; no arrhythmia; RSBI < 105 breaths/min/L). Respiratory distress signs included RR > 30 breaths/min, SaO2< 90%, HR > 140 beats/min, or a sustained change in HR of >20%, systolic BP >200 mmHg or <80 mmHg, or agitation, anxiety, or diaphoresis without other cause. The SBT lasted 120 min in accordance with prior studies. Upon SBT completion, the RSBI was re-measured and an ABG was obtained.
15890353|NCT03724617|Drug|umbilical cord mesenchymal stem cells combined with collagen scaffold|3-7 days after the end of menstruation, we underwent hysteroscopic exploration and separation if there was intrauterine adhesions. Intraoperative endometrial biopsy, recording biopsy location, endometrial specimens sent to HE examination and immunohistochemistry (vwf detection of microvessel density). The umbilical cord mesenchymal stem cell combined with collagen scaffold was spread on the balloon scaffold and placed in the uterine cavity. 5 ml of saline was filled into the balloon, and B-ultrasound confirmed that the scaffold was attached to the uterine wall. The patient was hospitalized for 2 hours and the patient's vital signs were recorded.
15890354|NCT03724604|Diagnostic Test|Neuron-Specific Enolase to Albumin Ratio|Previous studies have shown that inflammation and nutrition-related factors such as CRP/Alb (C-reactive protein-albumin ratio), PLR (platelet-to-lymphocyte ratio), NLR (neutrophil-to-lymphocyte ratio) can help to assess the prognosis of malignant tumors. This study is the first time to combine NSCLC tumor marker NSE and patient nutrition-related indicators Alb to predict the prognosis of patients, trying to find high sensitivity and specificity for NSCLC prognostic indicators to guide clinical work.
15890355|NCT03724591|Procedure|a high ligation of IMA|total mesorectal excision (TME) for rectal cancer by a high ligation of IMA without preservation of left colic artery
15890356|NCT03724591|Procedure|a low ligation of IMA|total mesorectal excision (TME) for rectal cancer by a low ligation of IMA with preservation of left colic artery
15890357|NCT03724578|Drug|Grape Seed Extract mouth wash|participants will use grape seeds extract mouth wash in addition to standard preventive measures
15890358|NCT03724578|Drug|standard preventive measures|twice daily brushing with fluoride tooth pate and daily flossing
15890359|NCT03724578|Drug|antimicrobial and fluoride mouth wash|using chlorhexidine and fluoride containing mouth wash
15890360|NCT03724565|Procedure|Method of endoscopic procedure|Air quality according to the method of endoscopic procedure will be checked (for example, upper diagnostic endoscopy, colonoscopy, endoscopic submucosal dissection, endoscopic mucosal resection, etc)
15890361|NCT03724552|Device|Transcranial LED Therapy|Transcranial Laser Emitting Diode (LED) Therapy (TLT) is a noninvasive intervention in which near-infrared light (830nm) is applied to forebrain.
15890362|NCT03724539|Device|STRIPA intervention|"STRIPA is a Dutch software-based tool for the support of the pharmaceutical analysis by 1) taking into account the predictable adverse medication effects, 2) advising safe and appropriate therapy using established STOPP/START criteria, 3) interaction monitoring, and 4) appropriate dosing in accordance with renal function. It represents a highly efficient and user-friendly software engine, which is capable of individually screening the clinical status and pharmacological therapy of older patients with multimorbidity, which can define optimal drug therapy, and which can highlight the adverse drug reaction risk. A summary of these outputs will be used as STRIPA recommendations, which will, if applicable, be implemented by GPs and patients.
~Prior to the STRIPA medication review, the necessary patient information will be loaded from the FIRE database that contains data from more than 300 Swiss GP practices."
15890363|NCT03724539|Other|Sham intervention|Patients being assigned to the control arm will be treated in accordance with standard care. They will receive a sham intervention, which consists of a usual medication review by their GP and a shared decision making between patient and GP.
15890423|NCT03724084|Drug|Pinometostat|Given IV
15890641|NCT03722459|Device|MR Fingerprinting|The MR fingerprinting technique requires less than 15 minutes and will be added following the standard MRI sequence.
15890365|NCT03724487|Behavioral|Coachman|Coachman is comprised of: TBI and nurse counseling. TBI is comprised of: 1) web-based education modules on hypertension knowledge and skills as well as behavioral lifestyle guidance, (2) Medisafe, a smartphone medication management app to support medication adherence to antihypertensives, and (3) self-monitoring blood pressure. Participants will be exposed to nurse counseling, by registered nurses from the community, affiliated with a local nurse organization that will serve as community health workers (CHWs). The CHWs will provide informal counseling, social support, as well as follow-up phone sessions on medication adherence and monitoring blood pressure.
15890366|NCT03724487|Behavioral|Enhanced Usual Care (EUC)|Standard printed education materials on hypertension management, including content on lifestyle modification and medication-taking will be provided; plus access to one web-based education (video) with information on how to self-monitoring blood pressure.
15890367|NCT03724474|Behavioral|Be SMART|The behavioral intervention will examine 12-week changes in sleep metrics and physical activity, compared to baseline measures, between subjects randomly assigned to a treatment (Be SMART) and an active control (Fitbit Only) condition (n=30, respectively).
15890368|NCT03724461|Behavioral|High Intensity resistance training (12 weeks)|High intensity resistance training (80% of 1 repetition maximum), 2 d/wk (Longitudinal)
15890369|NCT03724461|Behavioral|Light-moderate intensity resistance training (12 weeks)|Light-moderate intensity resistance training (40% of 1 repetition maximum), 2 d/wk (Longitudinal)
15890370|NCT03724461|Behavioral|Control (12 weeks)|No resistance training during the intervention period.
15890371|NCT03724461|Behavioral|One High Intensity resistance training session|High intensity resistance training, 1 training session
15890372|NCT03724461|Behavioral|One Light-moderate intensity resistance training session|Light-moderate intensity resistance training, 1 training session
15890373|NCT03724448|Drug|aleozen|treatment with herbal medicine
15890374|NCT03724448|Drug|Placebo Oral Tablet|No aleozen treatment
15890375|NCT03724422|Radiation|Radiation|A dose of 500cGy will be delivered in 1 fraction to the isocenter. Radiation will be administered no later than 72 hours postoperatively
15890376|NCT03724409|Drug|[90]Y-DOTATOC|Intra-arterial infusion to the liver of [90]Y-DOTATOC. The administered dose is determined by cohort and is dependent upon the results of the previous cohort.
15890377|NCT03724396|Behavioral|Behavioral Weight Loss - BWL|All participants will be instructed on how to consume a balanced deficit diet of conventional foods; individual goals for energy intake will be based on initial body weight. Participants will be instructed in measuring portion sizes, counting calories (with a calorie counter provided or on their phone), and self-monitoring food intake. The physical activity program will focus on increasing both lifestyle activity and structured exercise programs. Behavior change recommendations include stimulus control, self-monitoring, goal setting, managing high-risk situations, meal planning, slowing eating, problem solving, social support, cognitive restructuring, lapse and relapse prevention skills, and maintaining weight loss.
15890378|NCT03724396|Behavioral|Novel Executive Function Training - NEXT|Modifies programs like CogSMART and cognitive remediation training to help participants improve executive functioning to adhere to recommendations from BWL.
15890379|NCT03724383|Behavioral|Risk Factor Management Consult|Participants may be referred to an Internist to control risk factor management - this may require monthly visits until risk factor targets have been met.
15890380|NCT03724383|Behavioral|Diet Classes|Group nutrition sessions delivered two times per week (1 hr each), over a 3 month period (months 0 to 3 of intervention) delivered by a registered dietitian.
15890381|NCT03724383|Behavioral|Stress Management Classes|Group sessions delivered two times per week (1 hr each), over a 3 month period (months 0 to 3 of intervention). Techniques taught will include awareness, coping, and relaxation strategies.
15890382|NCT03724383|Other|Exercise Classes|Group sessions delivered two times per week (1 hr each), over 3 month period (months 3-6). Classes will include high intensity interval training, resistance training.
15890383|NCT03724383|Other|Home based exercise program|The interval and resistance training program will mirror the supervised exercise.
15890384|NCT03724370|Behavioral|Telehealth Monitoring System|TES will be conducted daily via Interactive Voice Response System (IVRS) during the 12 week study period.TES will be added to VHA-SRM.
15890385|NCT03724370|Other|VHA-SRM|Veterans Health Administration Suicide Risk Management supportive services will be provided to participant during the 12 weeks of study participation.
15890386|NCT03724357|Drug|Vaxchora|One dose. Approximately 100 mL of cold or room temperature purified bottled water is placed into a clean disposable cup. The contents of the buffer sachet are added to the water and stirred. Then the contents of the active (lyophilized vaccine) sachet are added to the water and stirred for approximately 30 seconds. The reconstituted mixture should be completely ingested within 15 minutes.
15890387|NCT03724344|Other|Cross section resaerch|Assessment of cognitive (MoCA), mental behavioral symptoms (NPI） the Self-rating Depression Scale (SDS) and the Self-rating Anxiety Scale (SAS).
15890388|NCT03724331|Behavioral|Light Physical Activity 1|"Light (mild) physical activity program that corresponds with normal every day activities of daily living (< 3.0 metabolic equivalents, METs), with a time commitment starting at 5 minutes a day 5 days a week gradually increasing to 30 minutes a day 5 days a week as you are able by week 6 as guided by your Registered Nurse researcher.
~The program begins approximately within one week after discharge from the hospital with the physical activity program starting approximately within the first week post-discharge from the hospital."
15890389|NCT03724331|Behavioral|Light Physical Activity 2|"Light (mild) physical activity program that corresponds with normal every day activities of daily living (< 3.0 metabolic equivalents, METs), with a time commitment starting at 5 minutes a day 5 days a week gradually increasing to 30 minutes a day 5 days a week as you are able by week 6 as guided by your Registered Nurse researcher.
~The program begins approximately within one week after discharge from the hospital with the physical activity program starting approximately 7 weeks post-discharge from the hospital."
15890390|NCT03724331|Behavioral|Support Education Activity|"Participate in a supportive cancer-related education activity including a direct 10 - 15 minute phone conversation with a Registered Nurse researcher each week for 6-weeks after returning home from the hospital. Wear a pedometer each day of the study.
~Recording pedometer steps in the daily diary each day."
15890391|NCT03724318|Procedure|closure of the left atrium appendage|closure of the left atrium appendage in addition to the planned Heart operation
15890392|NCT03724305|Behavioral|digital Cognitive Behavioral Therapy for Insomnia|"Cognitive Behavioral Therapy for Insomnia administered online through the Sleepio program. Treatment utilizes sleep restriction, stimulus control, and cognitive therapy. Treatment is administered through 6 weekly, hour-long online video sessions with an animated figure called The Prof, which delivers the treatment."
15890393|NCT03724305|Behavioral|Sleep Hygiene Education|Participants are provided with information about good sleep hygiene through 6 weekly emails. Participants practice good sleep hygiene as part of their sleep routine.
15890394|NCT03724305|Behavioral|mindfulness-augmented telemedicine Cognitive Behavioral Therapy for Insomnia|Mindfulness-augmented tCBT-I will use mindfulness-based stress reduction techniques to specifically target cognitive-emotional arousal associated with non-refractory insomnia while increasing the dose of and personalizing CBT-I to target insomnia.
15890395|NCT03724292|Drug|Placebo|Dose-matched placebo administered as oral capsule(s) once daily
15890396|NCT03724292|Drug|VTP-43742|VTP-43742 administered as oral capsule(s) once daily
15890397|NCT03724279|Device|ByCross Atherectomy and Thrombectomy|"After assessment of the lesion by angiography the ByCross is advanced over a 0.035 guidewire through a sheath to the occlusion. Activation will rotate the shaft and start aspiration. Under fluoroscopy the ByCross is advanced continuously over the wire. in case passage is not possible the ByCross tip is advanced into the occlusion for 10mm, then wire is advanced to check is passage is possible, this is repeated until passage by the wire is achieved. At harder lesion the speed is set to high. Once the occlusion is crossed the ByCross tip is enlarged, device is advanced once more to increase opening. Additional adjunctive treatment may be performed per physician's discretion and according to standard of care. Performance criteria of the intervention is to achieved more than 70% opening."
15890398|NCT03724266|Drug|Chitosan|chitosan will be used as intracanal medication
15890399|NCT03724266|Drug|Calcium Hydroxide|intracanal medication
15890400|NCT03724253|Drug|[68Ga]-NeoBOMB1|[68Ga]-radiolabeled bombesin peptide targeting Gastrin Releasing Peptide Receptors
15890401|NCT03724240|Biological|Placebo solution|4 x 2 injection over 21 days the dosage is100 µg/ml
15890402|NCT03724240|Biological|gpASIT+TM|4 x 2 injection over 21 days the dosage is100 µg/ml
15890403|NCT03724227|Drug|ACE-011|ACE-011 will be administered subcutaneous injection
15890404|NCT03724214|Combination Product|Pre-hospital interventional care bundle|"The interventional care bundle will include pre-hospital and in-hospital components and core and adaptable components. All seven centres will implement the core pre-hospital and in-hospital components. Implementation of the adaptable components will be decided by the local team to optimise the interventional care bundle to the local environment.
~Pre-hospital core components: 1) covering the bowel in clear plastic, 2) administering intravenous fluids, 3) keeping the neonate warm, 4) transferring to a study centre as soon as possible. This will be implemented as a pre-hospital gastroschisis care protocol to district and secondary level hospitals who refer patients with gastroschisis to the study centres.
~Pre-hospital adaptable components: 1) the strategy for disseminating the pre-hospital gastroschisis care protocol."
15890405|NCT03724214|Combination Product|In-hospital interventional care bundle|"In-hospital core components: 1) use of a standardised care protocol, 2) neonatal resuscitation and ward care including intravenous access, intravenous fluids, maintenance of normothermia, appropriate antibiotics, regular monitoring and infection control, 3) gastroschisis reduction and sutureless closure using a preformed silo and avoidance of neonatal anaesthesia and surgery, 4) early establishment of breastfeeding and an enhanced enteral feeding programme.
~In-hospital adaptable components: 1) administration of parenteral nutrition for neonates who have survived for 1-week in hospital, 2) maternal involvement in monitoring and basic management, 3) management of neonates with gastroschisis on the neonatal intensive care unit if available."
15890406|NCT03724188|Procedure|surgical parathyroidectomy|total parathyroidectomy, subtotal parathyroidectomy, total parathyroidectomy with autotransplantation
15890407|NCT03724175|Drug|ursodiol (ursodeoxycholic acid, UDCA)|ursodiol (ursodeoxycholic acid, UDCA) 300 mg two times daily for 10 weeks for UC pouchitis patients
15890408|NCT03724149|Drug|Zepatier|Zepatier (grazoprevir 100mg and elbasvir 50 mg once daily) is taken by mouth for 12 weeks unless a genetic variation is detected. In this case treatment with Zepatier will be extended to 16 weeks. Study subjects with treatment failure will be provided open-label Zepatier + sofosbuvir (sovaldi) 400mg + Ribavirin (generic), renally dosed based on creatinine clearance per the manufacturer guidelines.
15890409|NCT03724149|Drug|Epclusa|Epclusa (sofosbuvir 400mg and velpatasvir 100mg once daily) is taken by mouth for 12 weeks. Study subjects with treatment failure will be provided an alternative DAA + sofosbuvir (sovaldi) 400mg + Ribavirin (generic), renally dosed based on creatinine clearance per the manufacturer guidelines.
15890410|NCT03724136|Procedure|Intravenous Bone Marrow Stem Cell (BMSC) Fraction|14 cc of BMSC fraction separated from bone marrow aspirate and filtered with 150 micron filter and administered intravenously.
15890411|NCT03724136|Procedure|Intranasal Topical Bone Marrow Stem Cell (BMSC) Fraction|Approximately 1 cc of BMSC fraction separated from bone marrow aspirate and administered to the nasal mucosa topically.
15890412|NCT03724136|Procedure|Near Infrared Light|Near Infrared Light will be administered using an FDA cleared medical device on the preoperative day and the first postoperative day as tolerated to the general area of the frontal bone.
15890413|NCT03724110|Other|Telestroke|Telestroke is an audiovisual communication network that allows for coordination of stroke care from a distant 'hub' site (the telestroke provider location) to an originating 'spoke' site (patient location) in a HIPAA compliant fashion. In TELECAST-TIA, inpatient telestroke rounding will be used to oversee the urgent diagnostic TIA evaluation, secondary stroke prevention, and stroke education in patients admitted with TIA.
15890414|NCT03724097|Other|RNA sequencing|Next Generation Sequencing of RNA from tumor samples, rRNA-depleted.
15890415|NCT03724097|Other|Transcriptome analysis|Analysis of RNA-seq data using the Oncobox algorithm.
15890416|NCT03724097|Drug|target drug with the score above 0,1|target drug with the score above 0,1
15890417|NCT03724097|Drug|target drug with the score equal or below 0,1|target drug with the score equal or below 0,1
15890418|NCT03724097|Drug|non-target drug|non-target drug
15890419|NCT03724097|Drug|palliative care|palliative care
15890420|NCT03724084|Drug|Cytarabine|Given IV
15890421|NCT03724084|Drug|Daunorubicin|Given IV
15890422|NCT03724084|Drug|Daunorubicin Hydrochloride|Given IV
15890424|NCT03724071|Biological|TG6002|"Phase I, Arm A: Dose escalation from 1 x 10E6 PFU to 1 x 10E9 PFU; Phase I, Arm B: Dose escalation from 1 x 10E9 PFU to 1 x 10E10 PFU; Phase II: Established recommended Phase II dose (RP2D)
~Administration intravenously on Days 1, 8 and 15 (Phase I, Arm A) or on Days 1, 3 and 5 (Phase I, Arm B). Three intravenous infusions at the Dose Recommended for Phase 2 (RP2D) in Phase IIa.
~An extension of the 28-day cycle of TG6002/5-FC combination can be repeated in case of evidence of patient benefit, defined as an objective radiological response or disease stabilization, and/or a clinically significant relief in patient's symptoms. Additional cycle(s) will start from 2 to 4 weeks following the last 5-FC intake."
15890425|NCT03724071|Drug|Flucytosine (5-FC, Ancotil)|"Administered orally at a dose of 200 mg/kg/day for a total of 10 days (Phase I, Arm B) or 16 days (Phase I, Arm A).
~An extension of the cycle of TG6002/5-FC combination can be repeated in case of evidence of patient benefit, defined as an objective radiological response or disease stabilization, and/or a clinically significant relief in patient's symptoms."
15890426|NCT03724058|Device|Trident® II Clusterhole HA Acetabular Shell|Hip arthroplasty
15890427|NCT03724058|Device|Trident® Hemispherical Acetabular Shell|Hip arthroplasty
15890428|NCT03724045|Dietary Supplement|Back Side of the Moon|"The procedures are: several measurements will be performed, including some which are not part of the Standard Operating Procedure, hence causing it to be considered interventional.
~Follow-up during consultation on pneumology until max. 6 months post-admission on the ICU."
15890429|NCT03724032|Device|HD-tDCS*|Non-invasive brain stimulation (active protocol)
15890430|NCT03724032|Device|Sham HD-tDCS*|Non-invasive brain stimulation (sham protocol)
15890431|NCT03724019|Drug|Ketamine|Administration of 0.5mg / kg ideal body weight of ketamine at induction of anesthesia in laparoscopic surgery.
15890432|NCT03724006|Behavioral|Psychoeducational intervention|"The intervention, prepared by a multidisciplinary team, will consist of two 90 minutes collective sessions (max. 8 families). Sessions will consist of lectures, group discussion and relaxation. The program includes content on the effects of a diagnosis of a congenital anomaly on a child in the parents and in the family, stages of mourning, adaptation process, coping strategies, legislative framework and social protection. This is a non-specific intervention for CHD, where the main focus is the diagnosis of a congenital anomaly.
~In second session, written support material will be distributed. Participants will be asked to practice relaxation in the next 4 weeks."
15890433|NCT03723993|Device|Inflated cuff|After patient being draped, applying cuff inflation will be done to the upper arm not having the arterial line inserted of about 200 mmHg or 15 mmHg above patient's systolic pressure 3 cycles 5 minutes each followed by 5 minutes of pressure relieve
15890434|NCT03723993|Device|Non inflated cuff|non inflated cuff around the arm for the control group
15890435|NCT03723980|Drug|Propolis|it is a natural product obtained from beehive. it has been evaluated for biocompatibility and toxicity; and it is found that it is extremely biocompatible material. In our study, propolis powder will be mixed with saline in a ratio of 1 : 1.5 (propolis powder(wt) / saline(vol)) to form paste; and inserted into the root canals. it will be inserted once and will remain in root canals for 4 days.
15890436|NCT03723980|Drug|Calcium Hydroxide|it is a synthetic antimicrobial intracanal medicament and gold standard to which other medicaments are being compared. approximately 150 mg of calcium hydroxide paste will be inserted in the root canal. it will be inserted only once and will remain in root canals for 4 days.
15890437|NCT03723967|Drug|Durvalumab with Carboplatin/Paclitaxel|Durvalumab associated with Carboplatin / Paclitaxel as first line treatment in patients with recurrent/metastatic SCCHN not eligible to standard chemotherapy
15890438|NCT03723954|Device|ECG Holter SpiderFlash-t|"Record at visit V0 (day without match) and the competition days (Visit V1, V2 et V3) during the matches the heart rate of the golf fans.
~SpiderFlash-t™ from MicroPort is a long-lasting event recorder set in walking position by the investigator the day of the record and it is activated by detecting rhythm anomalies. This recorder is a Class IIA medical device (according to European Economic Community Directive 93/42). It benefits from European Economic marking."
15890439|NCT03723954|Device|Actigraph GT3Xp|"Record the study participant's physical activity while we record his heart rate.
~The GT3Xp based activity monitors provide objective measurements of human activity and are used in many research and clinical applications. It includes a micro-electro-mechanical system (MEMS) based accelerometer and an ambient light sensor. It benefits from CE marking and FDA agreement (Class II medical device)."
15890440|NCT03723941|Drug|Cisplatin plus Etoposide|"Etoposide 100 mg/m2 will be administered IV on days 1, 2, 3 diluted in 500 mL of isotonic NaCl or 5% dextrose.
~Cisplatin, 80 mg/m2 will be administered IV on day 1, diluted in 500 mL of isotonic NaCl."
15890441|NCT03723941|Other|Observation or Mitotane|Observation or mitotane alone according to the investigator's preference
15890442|NCT03723928|Other|Usual care disease monitoring|Imaging and serum tumor markers are at the discretion of the treating physician (however imaging must be performed at least every 12 weeks).
15890443|NCT03723928|Other|Serum Tumor Marker directed disease monitoring|Serum tumor markers every 4-8 weeks without imaging
15890444|NCT03723928|Other|Quality-of-Life Assessment|Ancillary studies
15890445|NCT03723928|Other|Anxiety Questionnaire Administration|Ancillary studies
15890448|NCT03723902|Other|Heavy-load strength training|Three weekly sessions of heavy-load strength training for 10 weeks
15890449|NCT03723902|Dietary Supplement|Protein supplementation|Daily supplementation of 2 x 17 grams of milk protein
15890450|NCT03723876|Behavioral|Body awareness therapy|"The physiotherapist uses body awareness techniques, i.e. guiding the participant in movement qualities such as stability, breathing, flow and grounding. Conscious awareness focused on bodily experiences is a key component to be able to reflect on what your body signals.
~As a baseline a standardized observation of the movement quality of the individual is performed. The physiotherapist needs special education in the body awareness technique used, to rightly perform and analyse the observation and administer the intervention.
~The aim of the body awareness therapy is to raise physical and mental awareness by strengthening the interplay between sensory impressions and motor ability and to gain knowledge of own movement patterns that are not functional and to form alternatives to these."
15890451|NCT03723863|Behavioral|Occupational Therapy|Receive in-person occupational therapist-led work consultation
15899322|NCT03654833|Drug|Rucaparib|PARP inhibitor
15890452|NCT03723850|Device|Active tDCS|The brain is stimulated for 20 minutes with mild electrical current (maximum 2 mA) with two 7 cm x 5 cm electrodes placed on the scalp, using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.
15890453|NCT03723850|Device|Sham tDCS|The brain is not stimulated for 20 minutes with mild electrical current, but instead a sham procedure is administered using a standard 1x1 tDCS Clinical Trials device (Soterix Medica, NY), specialized for double-blinding.
15890454|NCT03723837|Biological|Inactivated Polio Vaccine (IPV)|Children receive one or two doses of IPV based on study arm they fall in
15890455|NCT03723824|Drug|grazoprevir 100 mg/ elbasvir 50 mg, Zepatier®|grazoprevir 100 mg/ elbasvir 50 mg (Zepatier®, MSD) once daily for 12 weeks
15890456|NCT03723811|Drug|SJP002 BID|1 drop b.i.d for 12 weeks
15890457|NCT03723811|Drug|SJP002 QID|1 drop q.i.d for 12 weeks
15890458|NCT03723811|Drug|SJP002 Placebo 1|1 drop q.i.d for 12 weeks
15890459|NCT03723811|Drug|SJP002 Placebo 2|1 drop q.i.d for 12 weeks
15890460|NCT03723798|Drug|SA001 Low dose|3 tablets b.i.d for 12 weeks
15890461|NCT03723798|Drug|SA001 Mid dose|3 tablets b.i.d for 12 weeks
15890462|NCT03723798|Drug|SA001 High dose|3 tablets b.i.d for 12 weeks
15890463|NCT03723798|Drug|SA001 Placebo|3 tablets b.i.d for 12 weeks
15890464|NCT03723785|Drug|Insulin icodec|Participants will receive single dose of Insulin 287 subcutaneously (under the skin) on Day 1
15890465|NCT03723772|Drug|Insulin icodec|Participants will receive subcutaneous injections of insulin 287 once weekly for 8 weeks
15890466|NCT03723772|Drug|IGlar U100|Participants will receive subcutaneous injections of insulin glargine once weekly for 2 weeks.
15890467|NCT03723759|Drug|Faster Aspart 200 U/mL|A single dose (0.15 U/kg) of five formulations of fast-acting insulin aspart 200 U/mL (formulations A, B, C, D, E) in a sequential manner via subcutaneous injection.
15890468|NCT03723759|Drug|Faster aspart 100 U/mL|A single dose (0.15 U/kg) of fast-acting insulin aspart 100 U/mL via subcutaneous injection.
15890469|NCT03723746|Biological|JNJ-67670187|Participants in Cohorts 1, 3 and 4 will receive Dose 1 and participants in Cohorts 2, 5, 6, 7, 8 and 9 will receive Dose 2.
15890470|NCT03723746|Biological|Placebo|Participants will receive matching placebo in all cohorts.
15890471|NCT03723733|Behavioral|screen high and low triat subjects|use a range of questionniares to screen screen high and low triat subjects (eg. Autism, Anxiety, Depression traits and social network size)
15890472|NCT03723720|Device|Colonoscopy|Endoscopic examination of large bowel
15890473|NCT03723707|Behavioral|EQUIPED-ADRD Intervention|(10 clinic sites and ~500 patients) which includes practice guidelines for clinicians, provider education, electronic health record support for quality DM-ADRD care, information about community/clinical resources, ongoing targeted provider feedback, and a panel manager (PM)
15890474|NCT03723707|Behavioral|Control (CON)|Will use current guidelines for primary care treatment with Diabetes and Dementia
15890475|NCT03723694|Dietary Supplement|650 mg of Cocoapro flavanols|12-week period during which participant will be asked to consume two cocoa-flavanol-containing capsules(650mg) twice a day with meals.
15890476|NCT03723694|Dietary Supplement|0 mg of Cocoapro flavanols|12-week period during which participant will be asked to consume two cocoa-flavanol-containing capsules(0mg) twice a day with meals.
15890477|NCT03723681|Drug|Quizartinib|Quizartinib is provided as 20 mg tablets for oral administration
15890478|NCT03723655|Drug|mavacamten|mavacamten capsules
15890479|NCT03723642|Diagnostic Test|Initial serum malondialdehyde level|"Blood sample (0.4ml) will be obtained within 5 minutes before induction of general anaesthesia.
~Samples will be obtained in both groups (LAE and OAE)"
15890480|NCT03723642|Diagnostic Test|Final serum malondialdehyde level|Blood sample (0.4ml) will be obtained within 5 minutes after wound closure. Samples will be obtained in both groups (LAE and OAE)
15890481|NCT03723642|Diagnostic Test|Initial differential white blood cell count|"Differential blood counts (microscopic) will be obtained during pre-operative routine work-up.
~Samples will be obtained in both groups (LAE and OAE)."
15890482|NCT03723642|Diagnostic Test|Final differential white blood cell count|"Differential blood counts (microscopic) will be obtained 24h after the first sample (Initial differential blood count).
~Samples will be obtained in both groups (LAE and OAE)."
15890483|NCT03723642|Diagnostic Test|Initial c-reactive protein serum level|"C-reactive protein levels will be obtained during pre-operative routine work-up.
~Samples will be obtained in both groups (LAE and OAE)."
15890484|NCT03723642|Diagnostic Test|Final c-reactive protein serum level|"C-reactive protein levels will be obtained 24h after the first sample (initial c-reactive protein level).
~Samples will be obtained in both groups (LAE and OAE)."
15890485|NCT03723642|Diagnostic Test|Initial VOC|Volatile organic compound sampling (2 samples within 5 minutes) within 10 minutes before induction of general anesthesia
15890486|NCT03723642|Diagnostic Test|VOC 5min|Volatile organic compound sampling (2 samples within5 minutes) within 5 minutes after endotracheal intubation before skin incision.
15890487|NCT03723642|Diagnostic Test|VOC 15min|Volatile organic compound sampling (2 samples within 5 minutes) 15 minutes after skin incision.
15890488|NCT03723642|Diagnostic Test|VOC 30min|Volatile organic compound sampling (2 samples within 5 minutes) 30 minutes after skin incision.
15890489|NCT03723642|Diagnostic Test|VOC 45min|Volatile organic compound sampling (2 samples within 5 minutes) 45 minutes after skin incision.
15890490|NCT03723642|Diagnostic Test|Final VOC|Volatile organic compound sampling (2 samples within 5 minutes) within 5 minutes after skin closure.
15890491|NCT03723629|Other|No intercention|No intercention
15890492|NCT03723616|Behavioral|Control|Participants will view 24 ads with and without health warnings. Additionally, 16 control non-tobacco ads matched for graphical content, presence of text, people, and other factors will be randomly distributed among these ads.
15890493|NCT03723616|Behavioral|Text Only|Participants will view at random 24 ads twice, each ad will have a different health warning chosen at random with the caveat that each health warning will be seen 3 times. The 16 control ads will have text disclaimers to control for physical features of the ads.
15890576|NCT03722914|Drug|blank control 0mg|0 mg/pellet, 1pellet/time, 3times/day
15890642|NCT03722446|Device|Arrow Catheter Kit.|The group will be randomized to receive this labor analgesia kit.
15890494|NCT03723616|Behavioral|Text + Graphic|This arm is identical to the text only intervention except a graphic will be added to the health warning. Thus, each ad will be seen twice; the text + graphic warnings will be seen three times. The 16 control ads will have text disclaimers and logos or other images to control for physical features of ads.
15890495|NCT03723603|Device|Fibrillar collagen powder dressing|A powder-like fibrillar collagen microsponge composed of Type I porcine dermis collagen. The dressing is a currently marketed, cleared device in the United States, indicated for the management of full and partial thickness wounds: pressure ulcers, diabetic ulcers, caused by mixed vascular origin, venous ulcers, and several other wound types.
15890497|NCT03723577|Device|Fibrillar collagen powder dressing|A powder-like fibrillar collagen microsponge composed of Type I porcine dermis collagen. The dressing is a currently marketed, cleared device in the United States, indicated for the management of full and partial thickness wounds: pressure ulcers, diabetic ulcers, caused by mixed vascular origin, venous ulcers, and several other wound types.
15890498|NCT03723564|Drug|Lactated Ringers Solution for Injection|Using ultrasound guidance, a 22 gauge needle will be introduced into amniotic cavity. Warmed Lactated Ringers solution will be injected into the amniotic cavity until an AFI of 8.0 cm is achieved
15890502|NCT03723538|Drug|Dexmedetomidine|patients undergoing tracheal resection and reconstruction surgery were enrolled in this prospective observational pilot study to evaluate dexmedetomidine-based sedation after tracheal surgery in an Intensive Care Unit (ICU). Patients remain electively intubated with an uncuffed nasal endotracheal tube, awake and exhibit spontaneous breathing The neck was maintained in flexion through chin-to-chest sutures. Infusion of dexmedetomidine was started from a dosage of 0.7 μg kg-1 h-1 followed by dose titration to the target level of the sedation Richmond Agitation Sedation Scale, (RASS) score -1/-2 using a dose range of 0.2-1.4 μg kg-1 h-1.
15890503|NCT03723525|Combination Product|Package of HIV care|"A. Screening and management (Preventive / Pre-emptive therapies dosages) of different opportunistic infections (OI). Detail information mentioned in the manual (refer to uploaded protocol).
~B. Rapid ART Initiation
~PLHIV without suspicion or active OI: Initiate ART within seven days or same day after HIV serology disclosure
~PLHIV with suspicion or active OI: Defer initiation if clinical symptoms suggest tuberculosis or cryptococcal meningitis. Detail information mentioned in the manual (refer to uploaded protocol).
~C. Enhanced Adherence/Retention Support: mHealth: Receive text messages in mobile regarding appointment reminder (pill pick up, CD4 test, viral load test, early infant diagnosis (EID) test etc.) and general awareness messages (positive prevention, the importance of regular health check-up etc.). PLHIV with advanced HIV disease will also receive weekly/biweekly home-based adherence/ retention support linked to community care centre and community home-based care."
15890504|NCT03723525|Combination Product|Standard HIV care|Standard of HIV care includes screening and management of OI (OI- tuberculosis (TB), bacterial pneumonia, herpes, and candidiasis), baseline assessment (CD4 and other blood tests- complete blood count, hemoglobin, platelets, liver function test, renal function test, urine for albumin, chest x-ray), at 6 months CD4 test, viral load (twice a year) and then on a yearly basis, additional lab test at 3 months, 6 months, antiretroviral (ARV) toxicity monitoring like hemoglobin (Zidovudine), Serum Glutamic-Pyruvic Transaminase (Nevirapine/Efavirenz), Creatinine (Tenofovir), prophylaxis (Co-trimoxazole preventive therapy CD4<350 and WHO stage III and IV and Isoniazid preventive therapy if eligible) and ART / follow up (generally monthly/ bimonthly).
15890505|NCT03723512|Device|Non contrast-enhanced magnetic resonance imaging|Non contrast-enhanced magnetic resonance imaging
15890506|NCT03723499|Other|Medical data collection|Medical data collection by medical record will be collected: demographics data, medical history, clinical symptoms, smoking, type of endoscopic method, complete treatment or not, type of surgeries if yes, anatomopathology of the injury and recurrence if yes
15890507|NCT03723473|Device|Magnetic Resonance Imaging (MRI)|MRI (muscular volume and composition) and gated-P-31 magnetic resonance spectroscopy (MRS) with low-intensity ergometric exercise.
15890508|NCT03723460|Other|Passive Dietary Monitoring|Passive dietary monitoring devices will be used to monitor dietary intake in household in communities in Ghana and Kenya
15890509|NCT03723447|Drug|Liposomal bupivacaine|Liposomal bupivacaine will be given during the bilateral laparoscopic-guided TAP block given to each patient intraoperatively.
15890510|NCT03723447|Drug|Bupivacaine/epinephrine/dexamethasone|Bupivacaine/epinephrine/dexamethasone will be given during the bilateral laparoscopic-guided TAP block administered to each patient intraoperatively.
15890511|NCT03723434|Device|Single-pulse transcranial magnetic stimulation (spTMS)|Single-pulse TMS (spTMS) will be delivered with a TMS stimulator (MagPro X100 w/ MagOption, MagVenture, Farum, Denmark) and a figure-of-eight TMS coil. 80 spTMS will be repeated at 0.2 Hz. An MRI-based TMS navigation system will be used to navigate the TMS coil (Localite, St Augustin, Germany).
15890512|NCT03723434|Device|Paired associative stimulation (PAS)|Paired associative stimulation (PAS) will be applied with two TMS stimulators (MagPro X100 w/ MagOption, MagVenture, Farum, Denmark) and two TMS coils. The pulses from each stimulator/coil will be repeated at 0.2 Hz, duration of run 15 minutes (180 pulses for each stimulator/coil). In different sessions, we will deliver PAS with different asynchrony values to examine their effects on effective connectivity. Coils will be navigated using an MRI-based TMS navigation system (Localite, St Augustin, Germany).
15890673|NCT03722199|Other|Placebo|single intake of capsules with a placebo
15890513|NCT03723434|Device|Repetitive transcranial magnetic stimulation (rTMS)|Repetitive TMS (rTMS) will be applied at 1 and 20 Hz with a TMS stimulator (MagPro X100 w/ MagOption, MagVenture, Farum, Denmark) and a figure-of-eight TMS coil. 300 rTMS pulses will be delivered during 1 and 20 Hz stimulation. An MRI-based TMS navigation system will be used to navigate the TMS coil (Localite, St Augustin, Germany).
15890514|NCT03723421|Other|Rapid Injection Group Without Aspiration|After filling in the personal information form, the tetanus vaccine was administered by using rapid injection without aspiration technique (the injector was held at 90 degrees, it was pricked into tissue rapidly, and the drug was given in 1-2 seconds without performing aspiration). (the injector was held at 90 degrees, it was pricked into tissue rapidly, and the drug was given in 1-2 seconds without performing aspiration). 2 days after the vaccination, the researcher got in contact with the students in the intervention and the control groups in order to ask whether a local side effect developed in the vaccination site or not.
15890515|NCT03723421|Other|Control|After filling in the personal information form, the tetanus vaccine was made in accordance with the standard injection technique included in the application (the injector was held at 90 degrees, it was pricked into tissue, and the drug was given in 5-10 seconds after performing aspiration). 2 days after the vaccination, the researcher got in contact with the students in the intervention and the control groups in order to ask whether a local side effect developed in the vaccination site or not.
15890516|NCT03723408|Device|ClearLine IV (formerly, AirPurge)|Patient safety device that automatically and continuously detects and actively removes air from IV lines - protecting patients from dangerous air burden, air embolism, air infusions.
15890517|NCT03723395|Drug|tucatinib|300mg dose, orally administered
15890518|NCT03723395|Drug|itraconazole|200mg dose
15890519|NCT03723395|Drug|rifampin|600mg dose
15890520|NCT03723395|Drug|gemfibrozil|600mg tablets
15890521|NCT03723395|Drug|repaglinide|1mg dose
15890522|NCT03723395|Drug|tolbutamide|500mg dose
15890523|NCT03723395|Drug|midazolam|2mg dose
15890524|NCT03723395|Drug|digoxin|0.5 mg dose
15890525|NCT03723382|Other|SECRET structured 5 bundles of standard healthcare services|THE 5 BUNDLES OF Stroke SERVICE They the mix of the services for stroke patient which are available at the SS EVT bundle: is the availability of the Endovascular services Telemedicine core bundle : is the ability to guide or guided via tele-medicine for decision making for stoke patients tPA core bundle : the availability of all infrastructure to administer tPA in the first 3 hours of onset (NNT=8) DISMAST bundle : which refer to the availability of Dysphagia detection and management ,Aspirin in hyper acute phase , The Mobilization plans and programs for the patients, anticoagulant and statin prescription for selected patients for secondary prophylaxis programs Process of care bundle : like registering patients and morphology of the disease, screening programs for risk factors , following primary prevention plans all bundles should be judged by the 8M approach
15890526|NCT03723369|Device|accupuncture|accupuncture
15890527|NCT03723356|Diagnostic Test|Siemens Biograph mMR (molecular MR)|5mCi of the radiotracer FDG administered intravenously as a bolus over 30s. After injection, emission data will be collected for 60 min,
15890528|NCT03723356|Diagnostic Test|fMRI|High-resolution T1-weighted structural image will be acquired using an MP2RAGE sequence. Subject will beasked to look at the cross hair on a screen andnot fixate on any one thought.
15890529|NCT03723356|Diagnostic Test|Diffusion Spectrum Imaging (DSI)|DSI allows for more accurate characterization of diffusion,overcomes traditional dMRI artifacts, and is capable of more precise and detailedcharacterization of white matter fibers
15890530|NCT03723343|Drug|GP+IMRT|Gemcitabine 1000 mg/m2 intravenously, d1&d8 +Cisplatin 80 mg/m2 intravenously, d1 21~28 days/cycle, 4 patients with oligometastasis, 6 cycles with multiple metastases
15890531|NCT03723343|Drug|TPF+IMRT|Docetaxel: 75mg/m2 intravenous drip, d1+Cisplatin75mg/m2 intravenous drip, d1~d5+5-fluorouracil 750mg/m2/d intravenous drip, d1~d521~28 days/cycle, patients with oligometastasis take 4 cycles, moreTransfer patients for 6 cycles
15890532|NCT03723330|Dietary Supplement|plant sterols|Consumption a healthy eating pattern diet with a plant sterols-enriched food product
15890533|NCT03723330|Other|healthy diet|Compliance with a healthy diet in accordance to the recommendation by the Singapore Health Promotion Board.
15890534|NCT03723317|Procedure|Liver transplantation|First deceased-donor liver transplantation
15890535|NCT03723304|Procedure|Bridging followed by transplant|Trans-arterial chemoembolization or percutaneous alcohol injection or radio-frequency ablation during the waiting time followed by liver transplant
15890536|NCT03723304|Procedure|Direct liver transplant|Direct liver transplant (no neoadjuvant approaches during the waiting time period)
15890537|NCT03723291|Combination Product|Arm B: A combination of pentoxifylline and tocopherol acetate in addition to best standard care [a structured programme of rehabilitation exercises] for 6 months|• Arm B: A combination of pentoxifylline 800 mg/d in two 400-mg tablets and 1,000 IU/d of tocopherol acetate in two 500-IU aliquots in addition to best standard care [a structured programme of rehabilitation exercises] for 6 months
15890538|NCT03723291|Procedure|• Arm A: Best standard of care only [a structured programme of rehabilitation exercises] for 6 months|Prophylactic swallowing exercises consist of strap muscle exercises, airway protection exercises and base of tongue exercises
15890540|NCT03723252|Drug|Dapagliflozin|Participants will receive dapagliflozin 10mg po qd
15890541|NCT03723252|Drug|Placebo|Participants will receive placebo po qd
15890542|NCT03723239|Device|TricValve® System|The TricValve® Delivery System is inserted from the femoral vein to access the inferior vena cava (IVC) and superior vena cava (SVC) of the heart under fluoroscopy guidance. The appropriately sized TricValve® is unsheathed at the implantation site and positions itself as per the anatomy - self expanding frame.
15890543|NCT03723226|Behavioral|Low Load Resistance Exercise|Subjects allocated to Low Load Resistance Exercise will undergo 6 weeks of single-legged low load (25%) resistance exercise. Subjects will then perform 4 sets of 30, 15, 15 and 15 repetitions at 25% of their 1RM for the single-legged leg press and single-legged knee extensions. Their contralateral leg will serve as within subject control.
15890640|NCT03722472|Biological|ID93 + GLA-SE|The single-vial lyophilized vaccine will be reconstituted with WFI. For the two-vial presentation, the lyophilized ID93 will be reconstituted with WFI and mixed with liquid GLA-SE.
15890674|NCT03722186|Drug|SHR-1603|SHR-1603 monotherapy
15890544|NCT03723226|Behavioral|Low Load Resistance Exercise + BFR|Subjects allocated to Low Load Resistance Exercise + BFR will undergo 6 weeks of single-legged low load (25%) resistance exercise with blood flow restriction (60% occlusion pressure). Subjects will then perform 4 sets of 30, 15, 15 and 15 repetitions at 25% of their 1RM for the single-legged leg press and single-legged knee extensions. Their contralateral leg will serve as within subject control.
15890545|NCT03723200|Other|Fibrinogen and blood products|Fibrinogen and blood products
15890546|NCT03723187|Other|normal saline|experimental group use normal saline sealing tube
15890547|NCT03723187|Other|normal saline+heparin|normal saline+heparin(Currently, Regular used in hospital)
15890548|NCT03723174|Behavioral|Oral Health Educational Program|proper introduction to brushing techniques, dietary recommendations and importance of visiting the dentist
15890549|NCT03723161|Device|Bone Achored Hearing surgery|This is a observational study of pediatric patients undergoing bone anchored hearing surgery. The collected data will be used to assess the implant stability development of the Ponto BHX implant during up tp 24 months after implantation in a pediatric population undergoing bone anchored hearing surgery.
15890550|NCT03723148|Drug|Oral Fedratinib|Oral fedratinib administered as directed by treating physician.
15890551|NCT03723135|Drug|CC-486|Oral azacitidine administered as directed by treating physician.
15890552|NCT03723122|Behavioral|Dyadic Communication Reinforcement Intervention|Psycho-educative and behavioral intervention centered on cancer-related dyadic communication
15890553|NCT03723109|Procedure|Induction of anesthesia|Standardized TCI and RSI anesthesia induction
15890554|NCT03723096|Drug|CC-4047|CC-4047 will be administered orally
15890555|NCT03723083|Drug|CC-2001|CC-2001 will be administered orally
15890556|NCT03723070|Device|The Cryterion Cardiac Cryoablation System|Cryoablation System that includes a Balloon Catheter, Circular Mapping Catheter, Steerable Sheath and Cryoablation Console. In combination, components of the System will be inserted into the left atrium and a thermal injury at the PV ostium will be created to electrically isolate the veins
15890557|NCT03723057|Drug|AG-221|Oral AG-221 administered as directed by treating physician.
15890558|NCT03723044|Other|EEG and occulometry|Each participants will spend two sessions of EEG and occulometry during a visual cognitive task where she/her will be presented with multi-stable visual stimuli to gaze at for one or two minutes. Depending on the experimental conditions, the participant will provide or not her/his perceptual state (i.e. which stimulus has been perceived ).
15890559|NCT03723031|Drug|Misoprostol|400 microgram (2 tablets) misoprostol ( cytotec, Pfizer, G.D. Searle LLC) inserted rectally (before CS) in rectal group or intrauterine (200 microgram at each cornu) intraoperatively following the delivery of the placenta in intrauterine group.
15890560|NCT03723018|Behavioral|Meditation|10 minutes a day of meditation, done on your own time.
15890561|NCT03723005|Device|Neolight Phototherapy Mattress|Once a qualified patient is enrolled, he/she will be randomized to Neolight phototherapy or standard-of-care phototherapy, which is ordered by physician as part of routine. Duration of phototherapy exposure will be recorded as entered by RN in patient medical progress notes.
15890562|NCT03723005|Device|Standard-of-Care|Once a qualified patient is enrolled, he/she will be randomized to Neolight phototherapy or standard-of-care phototherapy, which is ordered by physician as part of routine. Duration of phototherapy exposure will be recorded as entered by RN in patient medical progress notes.
15890563|NCT03722992|Other|MBSR|Guided yoga and meditation practices
15890564|NCT03722979|Procedure|Cardiac surgery|The study will enroll patients having a planned cardiac surgery under extracorporeal circulation (CEC)
15890569|NCT03722953|Other|Control|"Ultrasound
~Blood Pressure
~Heart Rate
~Oxygen Saturation"
15890570|NCT03722953|Other|Aerobic Exercise|"Ultrasound
~Blood Pressure
~Heart Rate
~Oxygen Saturation"
15890571|NCT03722940|Drug|Magnesium sulphate|Before induction of anesthesia; children in group M received an iv bolus dose of magnesium sulfate (Magnesium sulfate ampoule 1 gm/10 ml, Eipico, Egypt) 40 mg Kg-1 over 5 minutes followed by 15 mg Kg-1 h-1 ivi until the start of skin closure.
15890572|NCT03722940|Other|Na CL 0.9%|Before induction of anesthesia; children in group C equivalent volumes of Na Cl 0.9% over the same period instead of magnesium sulphate.
15890573|NCT03722927|Drug|Bupivacaine|While in the operating room,if subject is randomized to bupivacaine, it will be injected into the surgical site. After surgery, oral and IV pain medications will be available to control pain. During the hospital stay, subject will rate pain on pain scales and monitor how much pain medications needed. Once discharged, PI/staff will provide a pain diary to record pain medication use and pain rating (0-10). Subjects will follow up with clinic at regularly scheduled appointment times at 1 week, 3 weeks and 5 weeks postoperatively. At those appointments, PI/staff will have subjects bring pain medication diary and fill out a pain assessment and a disability assessment related to recent surgery.
15890574|NCT03722927|Drug|Liposomal Bupivacaine|While in the operating room,if subject is randomized to Liposomal Bupivacaine, it will be injected into the surgical site. After surgery, oral and IV pain medications will be available to control pain. During the hospital stay, subject will rate pain on pain scales and monitor how much pain medications needed. Once discharged, PI/staff will provide a pain diary to record pain medication use and pain rating (0-10). Subjects will follow up with clinic at regularly scheduled appointment times at 1 week, 3 weeks and 5 weeks postoperatively. At those appointments, PI/staff will have subjects bring pain medication diary and fill out a pain assessment and a disability assessment related to recent surgery.
15890575|NCT03722914|Drug|Benzonatate 200 mg|200 mg/pellet, 1pellet/time, 3times/day
15890577|NCT03722888|Device|smokeSCREEN video game|smokeSCREEN video game is web-based videogame intervention focused on tobacco use prevention in teens. The game has 1.5-2 hours of unique game play and focuses on combustible cigarettes, e-cigarettes, and flavored tobacco products.smokeSCREEN. Guided by the social cognitive theory and the theory of planned behavior, smokeSCREEN addresses a range of challenges that teens often face involving peer pressure and the use of tobacco products. Participants are provided access to the smokeSCREEN game through a private, password-protected website link and instructed to complete the game.
15890578|NCT03722875|Drug|SHR-1210|SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.
15890579|NCT03722875|Drug|apatinib|Apatinib is a selective VEGFR2 inhibitor
15890580|NCT03722862|Dietary Supplement|Low fiber|Partially hydrolyzed guar gum (PHGG) commercially available as Sunfiber in 3 gram doses
15890581|NCT03722862|Dietary Supplement|Placebo|Participants will receive the placebo/dextrose.
15890582|NCT03722862|Dietary Supplement|High fiber|Partially hydrolyzed guar gum (PHGG) commercially available as Sunfiber in 6 gram doses
15890583|NCT03722849|Drug|Adenosine Triphosphate|Participants will inhale escalating concentrations of Adenosine Triphosphate (ATP) to induce cough and the urge-to-cough
15890584|NCT03722849|Drug|Capsaicin|Participants will inhale escalating concentrations of capsaicin to induce cough and the urge-to-cough
15890585|NCT03722849|Other|Functional Brain Imaging|Participants will have scans of their brain activity using 3 Tesla (3T) brainstem restricted functional brain imaging (fMRI)
15890586|NCT03722823|Drug|Tucatinib|300mg oral single dose
15890587|NCT03722810|Other|Intervention|"The intervention will be a structured in-depth interview with a patient with a chronic illness that has been chosen by the student's allocated GP teacher. These chronic diseases are the four conditions at the top of a list of diseases with high disability-adjusted life years (DALY) scores in Switzerland: ischaemic heart disease, low back pain, major depressive disorder and COPD.
~GP teachers and students will be told that the students' intervention interviews need to be unaccompanied and at patients' own homes. The interview will be followed by a structured interview with the practice nurse and then a structured debriefing interview with the GP teacher."
15890588|NCT03722810|Other|Sham comparator|In the sham comparator, the student's allocated GP teacher will be give the student time to read a document that gives information about consultation skills, and asks questions that the student will need to discuss with the GP teacher. The document is designed to have real educational value, and to complement BIHAM's department-based consultation skills teaching.
15890589|NCT03722797|Procedure|Metabolic Cost Testing Procedures|"The Oxycon Mobile™Portable VO2 Measurement system will be used to measure VO2 uptake during 2 walking tests. Test order will be randomized.
~Treadmill Test: Participants will walk on a treadmill at constant speed, based on the participant's self-selected gait speed, for 2.5 minutes in each stage. Walking will occur at 75% of self-selected gait speed in stage 1, 100% in stage 2, and 125% in stage 3.
~Over-ground Test: Participants will walk in an uncarpeted corridor on a course consisting of 2 cones, 20-meters apart. Participants will be instructed to walk at a constant speed for 2.5 minutes in each stage. Instructions will be to walk at their slow speed in stage 1, their usual, comfortable speed in stage 2, and their brisk speed in stage 3."
15890590|NCT03722784|Device|Invigor A (test)|silicone hydrogel lens
15890591|NCT03722784|Device|Invigor B (control)|silicone hydrogel lens
15890592|NCT03722771|Behavioral|Inhalation|lavender oil inhalation in a separate room for 3 minutes prior to surgery
15890593|NCT03722771|Other|Anxiety Questionnaires 1|Modified Dental Anxiety Scale was used to describe the level of the dental anxiety.
15890594|NCT03722771|Other|Anxiety Questionnaires 2|State-Trait Anxiety Inventory-State Scale was used to distinguish the true anxiety level of the patients from the anxiety level for a particular situation.
15890595|NCT03722771|Diagnostic Test|Vital Signs 1|Changes in vital signs 1 - blood pressure - before, during and after the procedure were noted.
15890596|NCT03722771|Diagnostic Test|Vital Signs 2|Changes in vital signs 2 - respiratory rate - before, during and after the procedure were noted.
15890597|NCT03722771|Diagnostic Test|Vital Signs 3|Changes in vital signs 3 - heart rate - before, during and after the procedure were noted.
15890598|NCT03722771|Diagnostic Test|Vital Signs 4|Changes in vital signs 4 - saturation - before, during and after the procedure were noted.
15890599|NCT03722758|Device|Spectrum TPH3|tooth restoration with two different restorative materials
15890600|NCT03722758|Device|Riva LC|tooth restoration with two different restorative materials
15890601|NCT03722745|Behavioral|TARGET|TARGET is manualized cognitive-behavioral treatment designed to help adolescents and adults with symptoms of posttraumatic stress
15890602|NCT03722745|Behavioral|TAU|It involves referral to an offsite community mental health provider with no attempt to control the treatment modality-type-quality (i.e., evidence-based-treatment or not).
15890603|NCT03722732|Procedure|pancreaticoduodenectomy|pancreaticoduodenectomy either laparoscopically or open will be done
15890604|NCT03722719|Other|the Knack|The Knack consists of voluntary PFM contractions before and during activities that increase abdominal pressure. Such contraction elevates the pelvic floor cranially, with consequent closure of the urethra, vagina and rectum, stabilization of the pelvic floor and avoidance of urine leakage.
15890605|NCT03722719|Other|PFMT|The rationale underlying intensive PFM strength training is that it might develop the structural support of the pelvis by raising the levator plate to a permanent, higher position within the pelvis and promoting PFM and connective tissue hypertrophy and stiffness. These conditions facilitate automatic and more efficacious activation of motor units (neural adaptation), which impedes descent during activities that increase abdominal pressure.
15890606|NCT03722719|Other|The Knack + PFMT|These participants will perform the exercises described for both the Knack and PFMT groups at the outpatient clinic and at home.
15890607|NCT03722706|Other|Educational handbook|The intervention being evaluated in this study is an educational handbook for parents of children with atopic dermatitis (AD). The handbook was developed and written by the interdisciplinary study team (psychologist, allergist, nurse practitioner, dermatologists, primary care physician, dietitian). Content was based on practice guidelines for AD management, consensus recommendations for therapeutic patient education for AD, and clinical experience of our study team. Content includes topics central to effective AD management, such as pathophysiology/course, elements of treatment plans, and strategies to improve quality of life, such as breaking the itch-scratch cycle, improving sleep, and coping with social-emotional issues.
15890608|NCT03722693|Device|Functional electrical stimulation based treatment|Two types of multi-pad electrodes will be used during this study. Both were designed for covering the extrinsic muscles of the hand. Electrodes are comprised of 8 pads that act as anodes and 32 pads that acted as cathodes. The shape and distribution of the conductive pads within the electrodes were designed considering the motor points for achieving different movement primitives (wrist extension, wrist flexion, fingers extension, fingers flexion, index extension, index flexion, thumb extension, and thumb flexion). Each participant will receive 5 assessment sessions:1. before starting the interventions, 2. after the 7 days of standard care, 3. after 7 days of first FES based protocol, 4.after another 7 days of standard care and 5. after seven days of the other FES based intervention
15890609|NCT03722680|Drug|Riluzole|Riluzole during chemotherapy (oxaliplatin)
15890610|NCT03722680|Drug|Placebo Oral Tablet|placebo
15890611|NCT03722667|Behavioral|Technology-based Component|This intervention is comprised of three technology components: a) six weekly web-based modules focused on improving knowledge and skills to manage hypertension; (b) personalized medication adherence support (SMS reminder messages, adherence feedback, health and lifestyle tips) through Medisafe app; and (c) self-monitoring blood pressure to support self-managing hypertension.
15890612|NCT03722667|Behavioral|TechSupport|"The TechSupport intervention is the combination of both an behavioral and emotional intervention.
~Technology-based Components: This intervention is comprised of three technology components: a) six weekly web-based modules focused on improving knowledge and skills to manage hypertension; (b) personalized medication adherence support (SMS reminder messages, adherence feedback, health and lifestyle tips) through Medisafe app; and (c) self-monitoring blood pressure to support self-managing hypertension.
~Positive Psychological Training (PPT): This intervention will include a structured online training and skill building for PPT accessible by smartphone on techniques to promote optimism, resilience, well-being, and self-confidence."
15890613|NCT03722654|Behavioral|MTFS-I Installation|MTFS-I Installation will focus on introducing MTFS-I components including weekly training modules and mock video segments to be coded, as well as monthly feedback reports summarizing therapist self-reported FT and CBT implementation in active cases. Facilitation will also be included to review progress and provide regular support.
15890614|NCT03722641|Other|Bread reference|Commercially available white wheat bread
15890615|NCT03722641|Other|Product 1: Milk|Developed reference product based on milk
15890616|NCT03722641|Other|Product 2: Full fat milk + oat|Developed product based on full fat milk with addition of oat
15890617|NCT03722641|Other|Product 3: Skim milk + oat, high fibre|Developed product based on skim milk with addition of oat giving a high fiber content to the product
15890618|NCT03722641|Other|Product 4: Skim milk + oat, low fibre|Developed product based on skim milk with addition of oat giving a lower fiber content to the product
15890619|NCT03722628|Diagnostic Test|MMP1 genotypes polymorphism|Determination of MMP-1 gene polymorphism By PCR amplification followed by restriction Fragment length polymorphism (RFLP) and gel electrophoresis
15890620|NCT03722602|Other|Standard rehabilitation after stroke|The program of the rehabilitation was designed specifically for each patient. It was prepared to match the patient's functional status and the defined goals. The subjects participated in exercise five days per week, for five weeks. During their stay at the Clinic, the patients took part in morning exercise and received individual practice, based on neuro-developmental treatment (Bobath concept), and proprioceptive neuromuscular facilitation (PNF) method, addressing the impaired motor abilities; if it was needed they also performed exercise based on equipment using biological feedback: Balance Trainer (static and dynamic parapodium) and Pablo system designed for upper limb training.
15890621|NCT03722589|Biological|Flublok|0.5 mL intramuscular dose of Flublok
15890622|NCT03722589|Biological|Flucelvax|0.5 mL intramuscular dose of Flucelvax
15890623|NCT03722589|Biological|Fluarix|0.5 mL intramuscular dose of Fluarix
15890624|NCT03722589|Biological|Fluzone|0.5 mL intramuscular dose of Fluzone
15890625|NCT03722589|Biological|Fluzone High-Dose|0.5 mL intramuscular dose of Fluzone
15890626|NCT03722576|Drug|Vidofludimus calcium|During the 6-month treatment period, subjects will receive 30 mg VC orally once daily. This will be preceded by a lead-in dosing period where subjects will receive 15 mg VC once daily for 1 week.
15890627|NCT03722563|Procedure|total laparoscopic hysterectomy with sacrocolpopexy|Surgical correction of anterior and/or apical pelvic organ prolapse by laparoscopy
15890628|NCT03722563|Procedure|total laparoscopic hysterectomy with lateral suspension|Surgical correction of anterior and/or apical pelvic organ prolapse by laparoscopy
15890629|NCT03722550|Other|Starter Infant Formula, Follow-up Formula, and Growing-up Milk Supplemented With a Blend of Five Human Milk Oligosaccharides|Study formulas are administered orally, ad libitum, from enrollment until 15 months of age
15890630|NCT03722550|Other|Breast-feeding|Exclusive Breast-feeding up to 4 months of age
15890631|NCT03722550|Other|Standard Starter Infant Formula, Follow-up Formula, and Growing-up Milk|Standard Study formulas are administered orally, ad libitum, from enrollment until 15 months of age
15890632|NCT03722537|Procedure|Osteochondral Allograft|The arthritic bone that the thumb rests on (the trapezium) is removed and replaced with femoral trochlear osteochondral allograft that is designed to be similar in morphology to the human trapezium articular surface.
15890633|NCT03722537|Procedure|Ligament Reconstruction Tendon Interposition|During the LRTI, the arthritic bone that the thumb rests on (the trapezium) is removed. A small cut is made in the forearm to release a tendon, which is moved to the base of the thumb to fill in the area from which the trapezium bone was removed. A small suture anchor is then placed into a thumb bone which holds everything together.
15890634|NCT03722524|Drug|amlodipine / indapamide / perindopril arginine FDC|CCB / diuretic / ACE inhibitor
15890635|NCT03722511|Dietary Supplement|Amino Acid Based Medical Food/Drink|Study Compound Enterade® is a medical food drink/beverage composed of a proprietary blend of electrolytes and amino acids.
15890636|NCT03722498|Drug|HAIC of FOLFOX|administration of oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
15890637|NCT03722498|Drug|Sorafenib|administration of Sorafenib
15890638|NCT03722485|Device|Negative Pressure Therapy w/ instillation and dwell (NPWTi-d)|Negative Pressure Therapy at -125mmHg for 3.5 hours followed by 10 minute dwell of saline solution for 6-9 days.
15890639|NCT03722485|Biological|Collagenase Ointment|Collagenase ointment applied daily to the wound and covered with secondary dressing for 6-9 days.
15890643|NCT03722446|Device|B.Braun Catheter Kit|The group will be randomized to receive this labor analgesia kit.
15890644|NCT03722433|Drug|Vigiis 101-LAB and sequential therapy|Vigiis 101-LAB is the probiotic containing Lactobacillus paracasei subsp. Paracasei, which is the isolate from Taiwanese by Prof. Pan. This strain is resistant to gastric acid and bile acid. Therefore, its survival rate in the gastrointestinal tract could be as high as 95%. Previous studies showed that Vigiis 101-LAB can modulate the gut microbiota, with 10% increase in Bifidobacterium species and 20% reduction in Clostridium difficile.
15890645|NCT03722433|Drug|Placebo and sequential therapy|Placebo without Vigiis 101-LAB component
15890646|NCT03722420|Drug|Radotinib|Patients randomized to the radotinib arms will receive 300 mg of radotinib BID (1 in the morning and 1 in the evening, at approximately 12-hour intervals).
15890647|NCT03722420|Drug|Imatinib|Patients randomized to the imatinib 400 mg arm will receive imatinib once a day throughout the study.
15890648|NCT03722407|Drug|Ruxolitinib|Ruxolitinib 5 mg tablets, 4 per dose
15890649|NCT03722394|Behavioral|Pain Neuroscience Education|15 minute verbal one-on-one education session
15890650|NCT03722381|Drug|Amlodipine Besylate|Pharmacokinetics
15890651|NCT03722368|Behavioral|RCHC|The RCHC group will receive a three hour psychoeducational intervention on common stress responses among healthcare providers and coping skills. They will also receive a booster session one month later which will reinforce these skills.
15890652|NCT03722368|Behavioral|RCHC+|The RCHC group will receive a three hour psychoeducational intervention on common stress responses among healthcare providers and coping skills. They will also receive a booster session one month later which will reinforce these skills. This intervention group will also receive on-going support groups and one on one counseling as needed.
15890653|NCT03722368|Other|Waitlist control|This group will served as the control group and will receive treatment as usual until the end of the study. At the end of the study they will have the opportunity to take part in the RCHC or RCHC+
15890654|NCT03722355|Radiation|Conventional RT|Radiation therapy
15890655|NCT03722355|Radiation|Hyperfractionated RT|Radiation therapy
15890656|NCT03722355|Drug|Carmustine|Chemotherapy
15890657|NCT03722342|Drug|TTAC-0001 and pembrolizumab combination|"Investigational product (IP): TTAC-0001 and Pembrolizumab (Merck, Keytruda®)
~Treatment groups: 3 dose levels
~Dose level 1 (optimal starting dose): TTAC-0001 12 mg/kg on D1, D8 and D15 + Pembrolizumab 200 mg on D1
~Dose level 2 (first escalation dose): TTAC-0001 16 mg/kg on D1, D8 and D15 + Pembrolizumab 200 mg on D1
~Dose level 0 (de-escalation dose): TTAC-0001 8 mg/kg on D1, D8 and D15 + Pembrolizumab 200 mg on D1
~Cycle: 3 weeks (21 days per cycle)"
15890658|NCT03722329|Drug|Eculizumab|Eculizumab Injection. 300 mg, single dose
15890659|NCT03722316|Other|Immersive Nature Video|"An approximately 15-minute digital nature experience using work by filmmaker Louie Schwartzberg-Visual Healing by Moving Art. Time-lapse, high-speed, and macro cinematography are incorporated within each video. Audiovisual content include vivid imagery of a variety of ecosystems and climates accompanied by calming instrumental music.
~Both the MCI/Mild dementia arm and the healthy older adult arm will experience this intervention."
15890660|NCT03722316|Other|Neutral Video|"This video will include clips from relatively non-arousing educational documentaries. Fifteen minutes of documentary content will be selected from a longer video, ensuring that the content remains as neutral as possible. Video selections were modeled after the work from Eryilmaz, Van De Ville, Schwartz, and Vuilleumier (2011) who identified very brief movie clips (i.e., <1 minute) that were rated as neutral as opposed to frightful or enjoyable.
~Both the MCI/Mild dementia arm and the healthy older adult arm will experience this intervention."
15890661|NCT03722303|Other|Fat Injection|Used by plastic surgeons, lipografting injects autologous fat to correct contour deformities. Plastic surgeons have witnessed the regenerative properties of fat transfer, and these clinical manifestations have fostered numerous studies defining fat as a rich source of pluripotent stem cells with the potential for reducing scar formation, bringing neo-angiogenesis, and providing a barrier against scar adhesions. This study applies the regenerative properties of autologous fat transfer to treat mild to moderate carpal tunnel syndrome in comparison to the current standard of care, corticosteroid treatment. Ideally, fat transfer would prevent scar formation and aid in nerve excursion along the canal, while the neoangiogenic and regenerative growth factors stimulate nerve regeneration.
15890662|NCT03722303|Drug|Steroid Injection|Standard of care non-operative treatment for the treatment of Carpal Tunnel Syndrome
15890663|NCT03722290|Drug|Metformin|Oral administration of metformin 250mg (twice a day) for the 1st week followed by metformin 500mg (twice a day) for the next 8 weeks.
15890664|NCT03722277|Other|Variable load training|Based on symptoms/strength measured in an isometric maximum strength test at five different angles of knee flexion- and extension, participants will be training with variable load during both concentric and excentric phase of the dynamic movement. Initially participants will start at 40% of symptom limited isometric strength, this will increase to 50% during the training period.
15890665|NCT03722277|Other|Conventional strength training|Conventional strength training with rubber bands in knee flexion- and extension, additionally hip abduction- and adduction.
15890666|NCT03722264|Device|OpalSeal|OpalSeal is a fluoride releasing orthodontic primer that is FDA approved for use during bonding of orthodontic brackets
15890667|NCT03722264|Device|TransbondXT|Transbond is a primer used to bond orthodontic brackets that does not contain fluoride
15890668|NCT03722251|Behavioral|Glucose beverage, control beverage, glucose beverage and active video game playing, control beverage and active video game playing|
15890669|NCT03722238|Drug|Ibuprofen 600 mg Immediate Release/Extended Release Caplet|Ibuprofen 600 mg Immediate Release/Extended Release Tablet to be adminstered orally (i.e., one caplet every 12 hours, not to exceed 2 caplets per day) for pain.
15890670|NCT03722225|Other|Carbohydrate loading and high intermittent carbohydrate intake during physical exercise|The intervention consisted of carbohydrate loading prior to and intermittent high carbohydrate intake during PE and a proactive use of Real-Time Continuous Glucose Monitoring (rtCGM) to achieve and maintain glucose control
15890671|NCT03722212|Diagnostic Test|METAglut1|A blood draw is performed on each patient for the METAglut1 test, and sent to Laboratoire CERBA, Saint-Ouen l'Aumône, France, for sample analysis.
15890672|NCT03722199|Dietary Supplement|flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances)|single intake of capsules with flavanols (subgroup of polyphenols, subgroup of phenolics, natural substances)
15890677|NCT03722160|Device|Solo TympanostomyTube Device|The Solo Tympanostomy Tube Device is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure.
15890678|NCT03722147|Biological|AK105|AK105 200 mg intravenously (IV) every-2-weeks (Q2W)
15890679|NCT03722134|Procedure|MOCA|Great saphenous vein occlusion with a mechanochemical chateter which cause mechanical injury to vessel intima and gives sclerosant to the intima.
15890680|NCT03722134|Procedure|EVLA|Great saphenous vein occlusion with a thermal laser chateter
15890681|NCT03722134|Procedure|RFA|Great saphenous vein occlusion with a thermal radiofrequency chateter
15890682|NCT03722108|Combination Product|Regorafenib and Irinotecan|Irinotecan (180 mg/m² on D1 and D15 of a 4-week cycle) combined with regorafenib (160 mg daily on D2-8 and D16-22 of a 4-week cycle) administered until progression of disease or unacceptable toxicity
15890683|NCT03722108|Drug|Irinotecan|Irinotecan (180 mg/m² on D1 and D15 of a 4-week cycle) administered until progression of disease or unacceptable toxicity
15890684|NCT03722095|Device|active tDCS|A current of 2 milliampère (mA) through electrodes of 5x5cm.
15890685|NCT03722095|Device|sham tDCS|Similar set-up as in the active tDCS, but stimulation is too short to cause any effects.
15890686|NCT03722095|Device|iTBS|54 cycles with 10 bursts of 3 pulses, train duration of 2 seconds and intertrain intervals of 6 seconds, results in 1620 pulses at 110% resting motor threshold.
15890687|NCT03722082|Behavioral|Enhancing Cognitive Reserve|The intervention is aimed at improving cognitive reserve in offsprings of patients diagnosed with schizophrenia or bipolar disorder. The program is composed of 12 sessions of 60 minutes and will be adapted according the three different age groups (6-12) (13-18) (18-25). Each group will include between 6-to-8 offsprings and conducted by 4 experienced neuropsychologists in both children and adults. The sessions are the following:
15890688|NCT03722082|Behavioral|Support intervention|The support group will schedule meetings with the participants in order to talk about their daily life with the possibility to talk about the difficulties they encounter.
15890689|NCT03722069|Other|Low sodium diet|Patients received low sodium diet (3g of sodium chloride/day) and a limit of fluid intake of 1000 ml/day.
15890690|NCT03722069|Other|Normal sodium diet|Patients received normal sodium diet (7g of sodium chloride/day) and a limit of fluid intake of 1000 ml/day.
15890691|NCT03722056|Procedure|Laparoscopic resection|all patients with suspected Gastric GIST undergoes laparoscopic resection. Tumour location decides the approach used for resection. Therefore, a variety of options such as local resections, wedge resections, transgastric resections, intragastric resection and partial gastrectomies were performed.
15890692|NCT03722043|Behavioral|Parenting Program|Parents will participate in a 5-week parenting program designed to uniquely work with veteran families. The program will target the following areas: mindful parenting strategies, emotional regulation, positive discipline, positive parenting/attachment, and sleep.
15890693|NCT03722030|Other|Baseline Measures|Accelerometer (steps), Biomarkers (finger prick for hemoglobin A1c and c-reactive protein), Anthropometrics (height, weight, waist and hip circumference), Body composition (dual-energy absorptiometry for measuring fat mass, lean mass, % body fat, visceral fat), Functional fitness test.
15890694|NCT03722030|Behavioral|Strength-Training|2 sessions per week (20-40 min), home-based resistance training
15890695|NCT03722030|Other|Mid-point Measures|Accelerometer (steps)
15890696|NCT03722030|Other|Post-Study Measures|Accelerometer (steps), Biomarkers (finger prick for hemoglobin A1c and c-reactive protein), Anthropometrics (height, weight, waist and hip circumference), Body composition (dual-energy absorptiometry for measuring fat mass, lean mass, % body fat, visceral fat), Functional fitness test.
15890697|NCT03722017|Other|Deprescribing intervention|"In addition to a medication history, a study Pharmacist or Nurse Practitioner will review the reconciled total enrollment medication list. The following information will be ascertained for each medication: (1) Medication Indication; and, (2) Deprescribing rationale: Rationales for deprescribing (i.e., stopping or reducing dose) will be assessed for each medication.
~Deprescribing Recommendations: For each medication recommended for deprescribing, the deprescribing action will be specified as: (1) Stop prior to hospital discharge without need for monitoring; (2) Stop prior to hospital discharge with symptoms/physiologic monitoring; (3) Stop at specified time point following hospital discharge; (4) Reduce over time with monitoring until medication is stopped; (5) Reduce to lower dose without need for monitoring; (6) Reduce to lower dose with symptoms/physiologic monitoring."
15890698|NCT03722004|Biological|mOPV1|Monovalent oral poliovirus vaccine type 1 is a type-specific, live, attenuated oral poliovirus vaccine that protects against poliovirus type 1.
15890699|NCT03722004|Biological|bOPV|Bivalent oral poliovirus vaccine is a live, attenuated oral poliovirus vaccine that protects against poliovirus types 1 and 3.
15890700|NCT03722004|Biological|fIPV|Fractional dose of inactivated poliovirus vaccine that protects against types 1, 2, and 3 (all polio serotypes). Given as a 0.1 milliliter (mL) dose (fractional) by intradermal injection in lieu of the full 0.5mL dose that is given intramuscularly.
15890701|NCT03721991|Dietary Supplement|Gama amino butyric acid (GABA)|food supplement Gama amino butyric acid (GABA) as capsules
15890702|NCT03721991|Dietary Supplement|placebo|matching placebo
15890703|NCT03721978|Biological|VGX-3100|1 milliLiter (mL) VGX-3100 will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.
15890704|NCT03721978|Biological|Placebo|1 mL of Placebo will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.
15890705|NCT03721978|Device|CELLECTRA™-5PSP|CELLECTRA™-5PSP is used for EP following IM injection of VGX 3100 or placebo on Day 0, Week 4 and Week 12.
15890706|NCT03721965|Drug|Itacitinib|Phase 1: Itacitinib administered orally once daily at the protocol-defined dose according to age cohort, with dose reductions or modifications based on safety assessments. Phase 2: Itacitinib administered orally once daily at the recommended dose from Phase 1.
15890707|NCT03721965|Drug|Corticosteroids|Phase 1 and 2: Methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose that is appropriate for the severity of disease as outlined per local treatment guidelines as background treatment.
15890803|NCT03721081|Drug|Lidocaine 1%/Epi 1:200000|Five minutes before skin incision, subcutaneous infiltration of 0.5 ml/kg of Lidocaine 1%/Epi 1:200000 Inj along a 3 cm extended endaural incision with a 23 G hypodermic needle administered was performed by the surgeon, who was blinded to the applied drug solution.
15890708|NCT03721952|Behavioral|Facilitator-Based Intervention|Facilitators interact in person or by telephone with patients, family, and clinicians both during and following the patient's ICU stay for 3 months. In-person contacts include visits to patients' homes and/or care facilities; phone contacts include calls to patients, families and clinicians. Patients and families have access to facilitators through phone and email 5 days per week. Facilitators may attend clinic visits with patients. In addition to checking directly with patients/families during regular contacts, facilitators also access the electronic health record to ensure they have accurate information about appointments and treatment plans and to document key points for the clinical team. Facilitators encourage referral to inpatient or outpatient palliative care services when needs are identified.
15890709|NCT03721939|Device|FLEX Scoring Catheter|Vessel preparation with the FLEX Scoring Catheter® with a 30° rotation between each passage is performed, followed by a DEB angioplasty.
15890710|NCT03721926|Other|Usual Care|Participants assigned to receive usual oncology care will not meet with the study nurses, though they may receive geriatric or palliative care consults at their request or at the discretion of their treating oncologist.
15890711|NCT03721926|Other|Geriatric Oncology Collaborative Care|Patients receive three visits with a trained study nurse. At each visit, the study nurse will assess the patient's symptom burden, functional status, comorbid conditions, psychosocial issues, and medication use. The nurses can refer patients to specialists as needed. The study nurses will meet with a supervising support team, consisting of clinicians from geriatrics, palliative care, social work, and pharmacy to discuss each patient and review documentation. Following the team meetings, the nurses will document recommendations in the medical record and communicate with the primary oncology team, either in person or via phone, as appropriate. The study nurses will contact the supervising team in between meetings for any urgent issues or questions that arise.
15890712|NCT03721913|Other|participation-based intervention|The participation-based intervention is a goal-orientated, family-centered, and self-determined approach that emphasize on solution strategies based on child and family-selected goals. Intervention strategies will be formed by analyzing the strength and needs of child, family, and environment, and implemented by collaboration between family and interventionists.
15890713|NCT03721900|Drug|SHX-001 Active low dose|ketamine transdermal patch
15890714|NCT03721900|Drug|Placebo|transdermal patch
15890715|NCT03721900|Drug|SHX-001 Active High dose|ketamine transdermal patch
15890716|NCT03721887|Device|Transcranial direct current stimulation|A consecutive 5-days course of tDCS will be delivered. In treatment group, true stimulation will be administrated and sham stimulation will be delivered in control group.
15890717|NCT03721874|Drug|Dapagliflozin 10mg|"The study consist of 2 weeks treatment period 1, 6-8 weeks wash-out period and 2 weeks treatment period 2.
~The subject may be administered dapagliflozin 10 mg during Period 1 or Period 2."
15890718|NCT03721874|Drug|Placebo matching to Dapagliflozin 10 mg|"The study consist of 2 weeks treatment period 1, 6-8 weeks wash-out period and 2 weeks treatment period 2.
~The subject may be administered placebo during Period 1 or Period 2."
15890719|NCT03721861|Device|Intra-operative neural cuff stimulation|A feasibility study consists of placing 2 electrodes around the radial or medial nerves intraoperatively. The movements caused by the electrical stimulation of these nerves are observed.
15890720|NCT03721848|Behavioral|Healthy community clinic NCD+MH|"NCD+MH Awareness Intervention Overview:
~i. Patients are assigned, at minimum, one health awareness lecture per month with a total of 28 lectures possible ii. Patients attend lectures on specific topics given by MoH staff, mainly nurses.
~iii. Topics tackled include: Diabetes, Hypertension, Asthma, Cardiovascular Disease, Reproductive Health, Healthy Nutrition, Smoking, Emotional Wellness, Stress Relief and Positive Coping.
~iv. Group nutrition and physical fitness counselling are incorporated into most health awareness lectures"
15890721|NCT03721848|Behavioral|Healthy community clinic NCD|"i. Patients are assigned, at minimum, one health awareness lecture per month with a total of 24 lectures possible ii. Patients attend lectures on specific topics given by MoH staff, mainly nurses.
~iii. Topics tackled include: Diabetes, Hypertension, Asthma, Cardiovascular Disease, Reproductive Health, Healthy Nutrition, and Smoking iv. Group nutrition and physical fitness counselling are incorporated into most health awareness lectures"
15890722|NCT03721835|Device|CONQUEST FN Femoral Neck Fracture System|Fracture fixation device consisting of a single plate and three screws
15890723|NCT03721822|Drug|[18F]NOS|[18F]NOS is an investigational radiotracer which each subject will have one [18F]NOS positron emission tomography/computed tomography (PET/CT) scan performed.
15890724|NCT03721809|Biological|Blood samples|"There are 3 specific blood sampling times for each patient, on D1, D2 and D5 (D1 being the day of inclusion): cytokine samples (IL-1β, IL-6, IL-10, TNF-α, IFN-gamma) on 5ml dry tube.
~On D1, a 2.5ml PAXgene tube will also be taken for each patient."
15890725|NCT03721796|Other|Audio recording of initial consultation and debriefing interviews.|Semi-structured debriefing interviews with participating oncologists and HIV-infected newly diagnosed cancer patients will follow the initial encounter. Interviews will be conducted over 45-60 minutes and will be semi-structured with open-ended questions to allow the interviewee to direct the flow of the conversation.
15890726|NCT03721783|Procedure|Cryoablation|Image guided cryoablation therapy of soft tissue lesions
15890727|NCT03721757|Biological|Nivolumab, Surgery, Radiotherapy|A single dose of nivolumab 7-14 days before curative surgery. A further single dose will be administered following surgery and prior to radiotherapy commencing. Six further doses of nivolumab will be received post radiotherapy
15890728|NCT03721757|Biological|Nivolumab, Surgery, Chemoradiotherapy|A single dose of nivolumab 7-14 days before curative surgery. A further single dose will be administered following surgery and prior to Chemoradiotherapy (cisplatin) commencing. Six further doses of nivolumab will be received post radiotherapy
15890729|NCT03721744|Drug|Napabucasin|Napabucasin will be administered twice daily, at 240 mg bid (480 mg total daily dose), one hour prior or two hours after meals
15890730|NCT03721744|Drug|Paclitaxel|Paclitaxel 80 mg/m^2 will be administered on Days 1, 8 and 15 of every 28-day cycle
15890731|NCT03721744|Drug|Gemcitabine|Gemcitabine 600 mg/m^2 will be administered intravenously following paclitaxel infusion on Days 1, 8 and 15 of every 28-day cycle
15890804|NCT03721081|Other|Na Cl 0.9%/Epi 1:200000|Five minutes before skin incision, subcutaneous infiltration of 0.5 ml/kg of Na CI 0.9%/Epi 1:200000 inj along a 3 cm extended endaural incision with a 23 G hypodermic needle administered was performed by the surgeon, who was blinded to the applied drug solution.
15890732|NCT03721744|Other|Standard of care treatment options|Patient will receive standard of care treatment options, including Fluorouracil /Leucovorin, Gemcitabine, Onivyde plus Fluorouracil /Leucovorin (if Onivyde has been approved to treat pancreatic cancer in the country/region) or best supportive care (BSC) alone, one of which will be assigned by the investigator, per Investigator decision
15890733|NCT03721731|Device|Obesity treatment with a Plication device|Plicating the stomach to treat obesity
15890734|NCT03721718|Biological|GLS-5300|[Part A] GLS-5300 0.3 mg at 0, 4, and 12 weeks (N=5) [Part B] GLS-5300 0.3 mg at 0, 4, and 12 weeks (N=5) GLS-5300 0.6 mg at 0, 4, and 12 weeks (N=25) GLS-5300 0.6 mg at 0 and 8 weeks (N=25)
15890735|NCT03721718|Device|Cellectra 2000 Electroporation|GLS-5300 administered ID followed by Cellectra 2000 Electroporation
15890736|NCT03721705|Device|Renew NCP-5|Treatment will be given 3-5 times a week for a total of 35 treatments over 12 weeks.
15890737|NCT03721692|Device|RIC|The patients will use RIC everyday for three months, 5 cycles 5min ischemic-5min reperfusion each day.
15890738|NCT03721679|Biological|Poly-ICLC combination treatment with aPD-1 (Nivolumab or Pembrolizumab) or aPD-L1 (Atezolizumab or Durvalumab) over 6 months|Same as above
15890739|NCT03721666|Other|CCTV footage to the medical dispatcher in OHCA|The medical dispatchers' perception of bystanders' responses and dispatchers' reflections about the added value of visual information in out-of-hospital cardiac arrests (OHCA) situations.
15890740|NCT03721653|Drug|Bevacizumab|5 mg/kg iv over 30 minutes day 1
15890741|NCT03721653|Drug|Irinotecan|165 mg/sqm iv over 60 minutes day 1
15890742|NCT03721653|Drug|Oxaliplatin|85 mg/sqm iv over 2 hours day 1
15890743|NCT03721653|Drug|L-Leucovorin|200 mg/sqm iv over 2 hours day 1
15890744|NCT03721653|Drug|5-fluorouracil|3200 mg/sqm 48 h-continuous infusion
15890745|NCT03721653|Drug|Atezolizumab|840 mg iv over 30 minutes (60 minutes at the first infusion) day 1
15890746|NCT03721640|Other|electrocardiogram|Autonomic and hemodynamic evaluation with different indices (LF, heart rate, Systolic, diastolic and mean arterial blood pressure, SaO2) during a sedation protocol for intubation and surfactant administration according the INSURE or LISA technique.
15890747|NCT03721627|Drug|Ledipasvir/Sofosbuvir|Direct acting anti HCV drugs
15890748|NCT03721614|Device|BioMime™ Morph - Sirolimus Eluting Coronary Stent System|Study Device :- BioMime™ Morph - Sirolimus Eluting Coronary Stent System Approximately 200 patients will be randomly enrolled in a 2:1 ratio [BioMime™ Morph (n=133) vs. XIENCE family (n=67)].
15890749|NCT03721614|Device|Xience family Everolimus Coronary Stent Systems|Active Control Device :- Xience family Everolimus Coronary Stent Systems Approximately 200 patients will be randomly enrolled in a 2:1 ratio [BioMime™ Morph (n=133) vs. XIENCE family (n=67)].
15890750|NCT03721601|Device|Heart rate monitor chest strap|Simultaneously with 5min Holter recording, 5min recording of chest strap ECG.
15890751|NCT03721601|Device|Wrist band photoplethysmography|Simultaneously with 5min Holter recording, 5min recording wrist band photoplethysmography.
15890752|NCT03721588|Other|Clinical interviews, psychometric scales were applied.|
15890753|NCT03721575|Procedure|Scarpa's preserving hernio-abdominoplasty|Scarpa's fascia is preserved during hernio-abdominoplasty
15890754|NCT03721575|Procedure|Classical hernio-abdominoplasty|Scarpa's fascia is removed during hernio-abdominoplasty
15890755|NCT03721549|Biological|Norwalk GI.1 Virus|Norwalk virus causes viral gastroenteritis, which is also known as acute nonbacterial gastroenteritis, food poisoning, food infection, or stomach flu.
15890756|NCT03721536|Diagnostic Test|hemodynamic parameters|vital signs on the monitor including heart rate, mean arterial pressure, peripheral oxygen saturation and End-tidal Carbon Dioxide
15890757|NCT03721536|Diagnostic Test|arterial blood gase|Arterial blood gas including partial oxygen pressure and partial carbon dioxide pressure is an important routine investigation to monitor the acid-base balance of patients, effectiveness of gas exchange, and the state of their voluntary respiratory control.
15890758|NCT03721523|Diagnostic Test|3 Dimensional tomographic Ultrasound|3-D tUS at five timepoints following acute ipsilateral stroke or Transient Ischaemic attack (TIA) to document carotid plaque volume and presence or absence of adverse plaque features.
15890759|NCT03721523|Diagnostic Test|Platelet Aggregometry|Blood test to test for platelet resistance to aspirin or clopidogrel and to measure effect of acute inflammatory response post event.
15890760|NCT03721510|Biological|PGT121 + VRC07-523LS|PGT121 + VRC07-523LS, dose 30 mg/kg each, given intravenously
15890761|NCT03721510|Biological|PGT121 + VRC07-523LS + PGDM1400|PGT121 + VRC07-523LS + PGDM1400, dose 20 mg/kg each, given intravenously
15890762|NCT03721497|Drug|Testosterone Undecanoate|The patients will be randomly assigned to either testosterone or placebo.
15890763|NCT03721484|Diagnostic Test|CINtec PLUS|CINtec PLUS testing will be used to triage HPV positive women to colposcopy
15890764|NCT03721471|Other|Scoring of frailty|"Patients will be scored by the Clinical frailty Scale
~Patients' hand-grip-strength will be measured by a dynamometer."
15890765|NCT03721458|Other|Sequence|Potentially identifying genetic defects that could have clinical significance
15890766|NCT03721445|Device|continuous positive airway pressure|Could the changes of HRV between PSG night and CPAP titration night predict the CPAP adherence?
15890767|NCT03721432|Drug|Pregabalin 150mg|pregabalin 150 mg capsules (Lyrica®,Pfizer) given 60 minutes prior to epidural anesthesia
15890768|NCT03721432|Drug|Placebo oral capsule|Placebo oral capsule given 60 minutes prior to epidural anesthesia
15890769|NCT03721419|Device|High Flow High Humidity device|High Flow High Humidity device has a flow generator built into the body of unit and can deliver flows between 10 to 60 Liters per minute (LPM) with oxygen bled in as needed in order to deliver specified Fraction of inspired Oxygen (FiO2)
15890770|NCT03721419|Device|Low Flow High Humidity device|Standard high humidity trach collar utilizing venturi device bleed in
15890771|NCT03721406|Drug|Ropivacaine|ropivacaine administerd via thoracic paraveretebral catheter
15890772|NCT03721393|Device|Wearable heart monitor|Participants will be fitted with a wearable heart monitor placed on the skin that measures physiologic signals. There is no intervention or treatment.
15890805|NCT03721068|Biological|iC9.GD2.CAR.IL-15 T-cells|Three dose levels are being evaluated: 0.5 x 10^6, 1.0 x 10^6, 1.5 x 10^6
15890806|NCT03721068|Drug|Cyclophosphamide|500 mg/m^2 IV dose on days 1-2 for lymphodepletion prior to cell infusion
15890773|NCT03721380|Behavioral|Treatment as usual|Patients receive some HIV risk education for the enrollment; after that, health education is delivered irregularly (1-2 times a month or none), based on the patient's needs. During MMT treatment, the participant receives monthly random urine testing for opiate use and HIV testing as needed. Monthly meetings between the patient and physician are expected to occur however, there is no structure to these sessions and content is considered to be quite variable.
15890774|NCT03721367|Other|Diagnostic Ultrasound|All individuals will undergo a blood draw for measurement of biomarkers of liver disease and an ultrasound with shear-wave elastography.
15890775|NCT03721354|Other|NAVA vs PSV - TCCD|"Patients will be submitted to 3 different 30 minutes ventilation trials: the first one in PSV mode, the second one in NAVA mode and the third one in PSV mode again. PSV will have PEEP setted by clinician and pressure support set in order to obtain Vt 6-8 ml/kg. NAVA will have the same PEEP as PSV and NAVA level will be set to obtain the same Peak of Inspiratory Pressure) of PSV.
~Trans cranial doppler technique will be performed to evaluate the blood cerebral flow speed (average/systolic speed) at the end of every ventilation trial. At the end of each trial, ABGs will be performed. Traces of flow, airways pressure (Paw) and electric diaphragmatic activity (EAdi) will be recorded and acquired through a dedicated ventilator software called NAVA tracker."
15890776|NCT03721341|Radiation|Palliative Radiation|Investigators should follow the principles of palliative radiotherapy as per the individual institution in order to alleviate symptoms or prevent complications. If radiotherapy is indicated, recommended doses are 8 Gy in 1 fraction, 20 Gy in 5 fractions, and 30 Gy in 10 fractions.
15890777|NCT03721341|Drug|Chemotherapy|Chemotherapy may be given as indicated.
15890778|NCT03721341|Drug|Immunotherapy|Immunotherapy may be given as indicated.
15890779|NCT03721341|Drug|Hormones|Hormones may be given as indicated.
15890780|NCT03721341|Other|Observation|Observation only is acceptable if this is the standard practice.
15890781|NCT03721341|Radiation|Stereotactic Ablative Radiotherapy|Total dose of radiation and number of fractions will depend on the site of disease. Doses are 20 Gy in 1 fraction, 30 Gy in 3 fractions (every 2 days), or 35 Gy in 5 fractions (daily).
15890782|NCT03721328|Combination Product|vancomycin hydrochloride and tobramycin sulfate|vancomycin hydrochloride and tobramycin sulfate via local irrigation
15890783|NCT03721315|Behavioral|Intervention|"The health literacy enhancement will comprise of the following:
~Practical day to day information to help manage the disease
~Benefits of medication and adherence
~Tips to improve managing shortness of breath
~Proper use of inhalers (if applicable)
~Managing daily activities"
15890784|NCT03721302|Other|Main study clinical sepsis|No intervention-Observational study
15890785|NCT03721302|Other|Microbiology sub study|Analysis of Bacterial isolates
15890787|NCT03721263|Biological|ASLAN004|Single Dose
15890788|NCT03721250|Other|epidural|thoracic epidural analgesia
15890789|NCT03721237|Other|EBC-assisted|"After definitive catheter positioning, esophageal balloon calibration will be performed in:
~volume-controlled mode with tidal volume set to obtain 6-8 lm/kg of ideal body weight (reference),
~pressure support ventilation (PSV) with support set to obtain a tidal volume ranging between 6-8 ml/kg of ideal body weight at equal PEEP of volume control mode (PSV baseline);
~PSV + sigh ventilation (sigh setting: total inspiratory pressure equal to 35 cmH2O at a rate of 1/ minute; inspiratory time equal to 4 seconds)."
15890790|NCT03721224|Diagnostic Test|Kiddie Schedule for Affective Disorders and Schizophrenia|Both of the clinical and control group will be evaluated via Psychiatric semi-structured interview
15890791|NCT03721211|Drug|[11C]Martinostat|a type of dye used for radiographic imaging of the HDAC protein
15890792|NCT03721211|Device|MR-PET scanner|PET, or positron emission tomography, is a type of imaging test that uses a tracer, or dye, to make detailed pictures showing the activities of the cells that make up tissues and organs
15890793|NCT03721198|Combination Product|Acidulated phosphorous flouride|Acidulated phosphorous flouride is used to prevent white spot lesions
15890794|NCT03721198|Other|Resin modified glass ionomer varnish|Resin modified glass ionomer varnish is used to prevent white spot lesions
15890795|NCT03721185|Combination Product|Dr.K. Treatment|Overweight and obesity treatment response
15890796|NCT03721172|Drug|Apremilast|Apremilast, oral, twice daily
15890797|NCT03721172|Other|Placebo|Placebo, oral, twice daily
15890798|NCT03721133|Diagnostic Test|Blood sampling|"20 ml blood that withdrawal from peripheral vein. Blood sampling time: less than 3 minutes.
~Sample examination: Purification circulating tumor cell by high sensitive tumor cell marker. Combine the medical record to analyze the relationship between circulating tumor cell and disease relapse"
15890799|NCT03721120|Diagnostic Test|InvisionFirst® molecular panel|"During the first visit, liquid biopsy will be performed using the InVisionFirst® panel. Cytological or histological sampling will be planned. According to InVisionFirst® results, treatment will be initiated:
~regardless of cytological/histological and tissue molecular analysis in case of EGFR, BRAF V600E-mutation, ALK- or ROS1-rearrangement identified on InvisionFirst® panel.
~regardless of molecular characterization performed on tissue sample in case of ERBB2-, BRAF non V600E-, c-MET-, KRAS-,LKB1-, NTRK and/or RET mutation on InVisionFirst® panel. Treatment will be based on pathology results and if appropriate on PD-L1 level of expression.
~for patients with none of the previous alterations, treatment will be initiated after obtaining pathology results and genomic characterization from the tumor tissue analysis."
15890800|NCT03721107|Biological|MRx1234 [Blautia Hydrogenotrophica]|MRx1234 is a live biotherapeutic product consisting of a lyophilised formulation of a proprietary strain of bacterium. The study dosing regimen is two capsules two times per day for the duration of the treatment period.
15890801|NCT03721107|Other|Placebo|Placebo control
15890802|NCT03721094|Other|Immersive virtual reality|In the IVR environment, four different 360-degrees videos were in sequence played as backdrop during the procedure. The videos reflected real life situations in the operating room with two videos representing calm periods, one video representing a light stressor and one video representing a severe stressor with a bleeding (2 ml/s) being triggered in the simulation. Participants complete the procedures while wearing the head mounted device.
15890930|NCT03720067|Drug|Carvedilol|6.25mg to 25mg / day
15890807|NCT03721068|Drug|Fludarabine|30 mg/m^2 IV dose on days 1-4 for lymphodepletion prior to cell infusion
15890808|NCT03721055|Radiation|18F-(2S,4R)4-fluoroglutamine|Undergo 18F-(2S,4R)4-fluoroglutamine PET/CT
15890809|NCT03721042|Device|olfactory measuring device|Patients blowing into bags then analysis by olfadiag system
15890810|NCT03721029|Device|Intraoperative nerve monitoring,|Intraoperative nerve monitoring, via electromyography, enables real-time identification of the location of the somatic fibers in the pelvic nerves that seem crucial for urinary continence control and erectile function.
15890811|NCT03721029|Procedure|standard of care robotic-assisted radical prostatectomy|With out the usage of intraoperative nerve monitoring
15890812|NCT03721016|Drug|MT10109L|MT10109Lwill be injected into either the GL, LCL, or both.
15890813|NCT03721016|Drug|Placebo|Placebo will be injected into either the GL, LCL, or both.
15890814|NCT03721003|Device|ICP monitoring|"4- Use the Touhy needle to tunnel under the scalp from the Burr Hole site to the desired MICROSENSOR exit site.
~5- Place the tip of the MICROSENSOR in the Parenchyma through the puncture in the Dura"
15890815|NCT03720990|Drug|Cholic Acid|Participants will be treated with cholic acid for 8 weeks
15890816|NCT03720951|Radiation|pudendal nerve|Fluoroscopic-guided pulsed R.F. to pudendal nerve bilaterally under image guidance
15890817|NCT03720951|Radiation|sacral n roots|Fluoroscopic-guided pulsed R.F. to nerve roots S 2, 3, 4 bilaterally under image guidance
15890818|NCT03720938|Other|Active Video Games|Nintendo Wii® AVGs from sports, balance, aerobics, resort and training categories.
15890819|NCT03720925|Procedure|TDI treatment|The TDI treatment was performed according to its complexity. Uncomplicated TDI received minimally invasive treatment (simple restorations and clinical and radiographic follow-up). Complicated TDI received invasive treatment (more complex restorations, endodontic treatment, confection of aesthetic devices, restraints).
15890820|NCT03720912|Behavioral|Online Learning Modules|The modules will include information about common family management skills: social support, problem solving, communication, and supportive behavior change strategies.
15890821|NCT03720899|Drug|NicoBloc|For Session 1, participants will use one drop of NicoBloc (which will block 33% of tar and nicotine) on their conventional cigarette and then will smoke this cigarette in session. Following smoking, they will discuss the effects of the NicoBloc on their withdrawal, cravings, and overall enjoyment of their cigarette. To bolster their in vivo NicoBloc experience, participants will be provided with NicoBloc to use between sessions to acclimate to the NicoBloc and to make practice quit attempts (PQAs). Sessions 2 and 3 are similar to Session 1 except they will use more NicoBloc product during the session and will be instructed to use the product between sessions.
15890822|NCT03720899|Drug|Nicotine Lozenge|Participants who receive nicotine lozenge (mini lozenge) will be given either a 2 or 4 mg lozenge to use in session, depending on how soon they smoke after waking. If a participant smokes within 30 minutes of waking, they start with the 4 mg lozenge; more than 30 minutes, they start with the 2 mg lozenge. They will be given lozenges between sessions to make PQAs.
15890823|NCT03720886|Biological|rhPTH（1-34） 28.2μg|Administered by subcutaneous injection
15890824|NCT03720886|Biological|rhPTH（1-34） 56.5μg|Administered by subcutaneous injection
15890825|NCT03720886|Biological|teriparatide acetate(Teribone™)|Administered by subcutaneous injection
15890826|NCT03720873|Drug|erlotinib or gefitinib or icotinib|Patients will be treated with erlotinib 150mgQD or gefitinib250mgQD or icotinib 125 mg TID
15890827|NCT03720873|Drug|Anlotinib|Patients will be treated with Anlotinib 12mg po d1-14 Q21d
15890828|NCT03720847|Drug|Estradiol Transdermal Patch 0.1 mg/24 hrs|Estradiol transdermal patch delivering 0.1 mg/24 hour administered by affixing to skin for 14 days starting on day 7 after ovulation
15890829|NCT03720847|Drug|Oral Micronized Progesterone|100 mg oral micronized progesterone taken orally twice daily for 14 days starting day 7 after ovulation
15890830|NCT03720847|Drug|Inactive Clear Patch|Matching placebo patch administered by affixing to skin for 14 days starting on day 7 after ovulation
15890831|NCT03720847|Drug|Placebo capsule|Matching placebo capsules administered twice daily for 14 days starting day 7 after ovulation
15890832|NCT03720821|Behavioral|Cognitive Training + fMRI|"Consented subjects will be asked to participate in the study for up to five months. Patients will be consented at the Washington University Department of Anesthesiology and will be asked to complete baseline resilience, pain, and anxiety and depression questionnaires, along with cognitive tests by pencil and paper that will be administered by a member of the research team. The participants will also be required to complete a computer-based Trails-making test, Color Match test, and NCPT (Neurocognitive Performance Test) battery at baseline, and undergo a functional magnetic resonance imaging (fMRI) session.
~All subjects will be asked to complete the three paper-pencil and computer-based measurements along with repeat pain questionnaire again 1-3 days after completion of training, undergo a second fMRI scan at that time, and complete the questionnaires again 3 months after the completion of training."
15890833|NCT03720808|Other|Balloon Blowing|The parents of the children in this group were asked whether their children had the latex allergy or not and the children without the allergy were included in the group. The children's skills of blowing balloon were observed before the procedure. Before starting the venous blood sampling procedure, the children were asked to choose a balloon in the color they preferred and to start blowing the balloon at least 20 seconds before the procedure. Venous blood sampling started as the children exhaled to blow up the balloon. Until the venous blood procedure ended, they continued to blow up the balloons.
15890834|NCT03720808|Other|Ball Squeezing|Before the venous blood collecting procedure, a soft ball was given to the right hands of the children and they were asked to squeeze and release this ball during the procedure.
15890835|NCT03720808|Other|Coughing|The children included in this group were asked to cough after taking a deep breath during the venous blood sampling procedure. Before the procedure, the researcher showed the children how they should cough and asked them to imitate. The venous blood sampling was not performed until the child successfully completed coughing. The child was directed by the researcher during the procedure. Just before the entrance of the needle, the child was asked to take a deep breath and the venous blood sampling procedure was started during coughing.
15890836|NCT03720808|Other|Control|No intervention was performed to reduce pain and fear in the control group.
15890931|NCT03720067|Drug|Rosuvastatin|20mg / day
15890932|NCT03720067|Drug|Placebo|Placebo of rosuvastatin
15890837|NCT03720795|Behavioral|Stepped Care CBT|"Stepped Care CBT is a multi-method, parent-led approach, consisting of two main steps. Step one involves a low-intensity delivery of CBT, consisting of more flexible, parent-led, at-home treatment. Participants who do not show improvement in symptom severity at the end of Step One, are then stepped up to receive Step Two. Step two involves a high intensity delivery of CBT, consisting of therapist-led, parent-assisted weekly treatment sessions."
15890838|NCT03720782|Device|LEGION Porous HA Tibial Baseplate and/or the LEGION Porous HA CR Femoral Component|LEGION Porous HA Tibial Baseplate (with and without holes) and/or the LEGION Porous HA CR Femoral Component
15890839|NCT03720769|Behavioral|Step-by-Step|Guided self-help programme delivered through an app/website for the treatment of depression
15890840|NCT03720769|Behavioral|Enhanced care as usual|Psychoeducation and information about where to get help (i.e., mhGAP trained primary health care centres)
15890841|NCT03720756|Other|Nickel-free diet|Subjects follow a nickel-free diet. Lists of acceptable foods will be provided to subjects.
15890842|NCT03720743|Other|Biodanza|Intervention group received a total of 10 sessions, once a week, over the course of two months. Each session lasted 60 minutes. All sessions began with a 10-minute warm-up period combining music and low-intensity movements as a welcome round, followed individual exercises, in pairs and/or groups, which included dance combined with exercises based on the five lines of Biodanza (vitality, sexuality, creativity, affectivity and transcendence). Finally, a celebration and farewell round of 10 minutes was held. At the end of each session, the participants were asked to share their experiences with the rest of the group.
15890843|NCT03720730|Other|EMA|"The mobile application (EMA) combines an explicit data collection with an implicit one.
~For the explicit data collection with Memind application, patients will have to answer specific questionnaires about sleep, appetite and social factors. Some of the questions will be asked on regular basis, at the same time everyday, while others will be asked randomly during the day (between 9 a.m and 9 p.m).
~The implicit data collecting will be carried out using smartphone sensors (application eB2)."
15890844|NCT03720717|Drug|Baclofen 10mg|Baclofen administration pre-operatively
15890845|NCT03720717|Other|Placebo|Placebo administration
15890846|NCT03720704|Device|GORE VIABAHN VBX Balloon Expandable Endoprosthesis|GORE VIABAHN VBX Balloon Expandable Endoprosthesis will be implanted in peripheral vessels in patients who require interventional treatment.
15890847|NCT03720691|Device|Real rTMS Supplementary motor area|There will be a series of four rTMS blocks separated by 10 minutes. Each block will consist of 15 to 25 pulse trains of 1-second duration at 25 Hz, with an intertrain interval of 10 seconds.
15890848|NCT03720691|Device|Sham rTMS Supplementary motor area|There will be no real brain stimulation in Sham rTMS, and participant will be blinded.
15890849|NCT03720678|Drug|etrumadenant|Etrumadenant is an A2aR and A2bR antagonist.
15890850|NCT03720678|Drug|mFOLFOX|Oxaliplatin, Leucovorin and 5-fluorouracil given as part of standard mFOLFOX chemotherapy regimen
15890851|NCT03720665|Combination Product|Caffeine_TMS|Caffeine group: participants will receive a caffeine tablet and all electrical stimulations in a random order [transcranial electrical stimulation (tACS 140 Hz at 1 mA, 0.4 mA, sham) and paired associative stimulation (PAS 25)] Placebo tablet: participants will receive a placebo tablet and all electrical stimulations in a random order [transcranial electrical stimulation (tACS 140 Hz at 1 mA, 0.4 mA, sham) and paired associative stimulation (PAS 25)]
15890852|NCT03720652|Behavioral|8-Week Mindful Self-Compassion (MSC)|"The 8-week MSC is a course of eight 2.5 hour weekly sessions that is based off self-compassion, a construct closely related to mindfulness. Self-compassion (SC) has three main interrelated components: self-kindness, common humanity, and mindfulness. MSC is an 8-session program that integrates SC and mindfulness.
~It includes the following components:
~Discovering Mindful Self-Compassion
~Practicing Mindfulness
~Practicing Lovingkindness
~Discovering your Compassionate Voice
~Living Deeply
~Meeting Difficult Emotions
~Exploring Challenging Relationships
~Embracing Your Life"
15890853|NCT03720652|Behavioral|6-Week Mindful Self-Compassion (MSC)|"The 6-week MSC is a course of six 1 hour weekly sessions that is based off self-compassion, a construct closely related to mindfulness. Self-compassion (SC) has three main interrelated components: self-kindness, common humanity, and mindfulness. MSC is an 6-session program that integrates SC and mindfulness.
~It includes the following components:
~What is Self-Compassion
~Practicing Self-Compassion
~Discovering your Compassionate Voice
~Self-Compassion and Resilience
~Self-Compassion and Burnout
~Going Forward This program is a shortened version of the 8-week program, specifically created for the needs of health care staff."
15890854|NCT03720639|Device|Abbott, Inc Confirm Rx™ versus Medtronic, Inc Reveal LINQTM|Comparing reliability and timeliness in data transmission between two implantable cardiac monitors.
15890855|NCT03720626|Drug|crizanlizumab|IV formulation with 30 min infusion, 5mg/kg dosage
15890856|NCT03720613|Drug|Naldemedine|0.2 mg tablet once a day at any time with or without food
15890857|NCT03720613|Drug|Lubiprostone|0.024 mg twice a day [adjust dose based on liver function]
15890858|NCT03720613|Drug|Naloxegol|25 mg tablet once a day in morning, 1 hour before or 2 hours after food
15890859|NCT03720600|Behavioral|MAB Intervention|The intervention is a 60-minute voice-recorded PowerPoint presentation on a mindfulness- and acceptance-based (MAB) intervention adapted from Eustis et al. (2017). This adaptation was informed by research on MAB therapies and other approaches to coping with discrimination (e.g., Watson, Black, & Hunter, 2016), as well as clinical experience providing an in-person workshop on MAB strategies for coping with racism-related stress.
15890860|NCT03720587|Other|Semi-structured interviews|Semi-struuctured telephone interviews
15890861|NCT03720574|Drug|Lorcaserin 10 mg BID|Lorcaserin 10 mg tablet each morning and evening for a duration of 48 weeks
15890862|NCT03720574|Drug|Matching Placebo BID|Matching Placebo tablet each morning and evening for a duration of 48 weeks
15890863|NCT03720561|Drug|Ibrutinib|Participants in this observational study with confirmed diagnosis of CLL receiving ibrutinib in routine clinical practice settings will be observed approximately for 3 years.
15890864|NCT03720548|Drug|LY3372993|Administered IV.
15890865|NCT03720548|Drug|Placebo|Administered IV.
15890866|NCT03720522|Procedure|Short cardiovascular MRI (CMR)|A short CMR without additional contrast administration will be performed immediately after the routine brain MRI (at admission or after 24h).
15891004|NCT03719430|Drug|Doxorubicin|Doxorubicin is an anthracycline antibiotic with antineoplastic activity 75 mg/m2 IV day 1 (21 day cycles)
15890867|NCT03720522|Procedure|Adenosine-perfusion cardiovascular MRI (CMR)|An adenosine-perfusion CMR using contrast medium (gadolinium) will be performed in all patients (except group 1) between 48h and 6 days after admission.
15890868|NCT03720522|Procedure|Blood draw|"The following study-specific parameters will be tested: neuropeptide Y 1-36, neuropeptide Y 3-36, total plasma metanephrines, metabolomics analysis
~Time points for blood draw: at admission (routine), 3h (routine), 24h (routine), 48h, 72h and 3 months."
15890869|NCT03720522|Procedure|Urine (collection over 24h)|"The following study-specific parameters will be tested: catecholamines.
~Time points for collection: at 24h, 72h, and 3 months"
15890870|NCT03720496|Biological|CD19-TriCAR-T|A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously at a target dose of 0.1-1 x 10^6 CAR+ T cells/kg body weight.
15890871|NCT03720483|Drug|N-acetyl cysteine then Placebo|Subject will receive N-acetyl cysteine first followed by Placebo
15890872|NCT03720483|Drug|Placebo then N-acetyl cysteine|Subject will receive Placebo first followed by N-acetyl cysteine
15890873|NCT03720470|Drug|PF-04965842 100 mg|"PF-04965842 100 mg, administered as two tablets to be taken orally once daily as follows:
~In the arm PF-04965842 100 mg + Injectable Placebo followed by PF-04965842 100 mg, PF-04965842 100 mg is taken together with Injectable Placebo from Day 1 until Week 16, then by itself from Week 16 to Week 20;
~In the arm Oral Placebo + Injectable Placebo followed by 100 mg PF-04965842 subjects take PF-04965842 100 mg from Week 16 to Week 20."
15890874|NCT03720470|Drug|PF-04965842 200 mg|"PF-04965842 200 mg, administered as two tablets to be taken orally once daily as follows:
~In the arm PF-04965842 200 mg + Injectable Placebo followed by PF-04965842 100 mg, PF-04965842 200 mg is taken together with Injectable Placebo from Day 1 until Week 16, then by itself from Week 16 to Week 20;
~In the arm Oral Placebo + Injectable Placebo followed by 200 mg PF-04965842 subjects take PF-04965842 200 mg from Week 16 to Week 20."
15890875|NCT03720470|Drug|Dupilumab|Two subcutaneous injections of Dupilumab 300 mg as a loading dose administered on Day 1 (for a total of 600 mg) followed by one injection once every two weeks (q2w) until Week 16.
15890876|NCT03720470|Drug|Oral Placebo|"Oral placebo (for PF-04965842) administered as two tablets to be taken orally once daily as follows:
~In the arm Dupilumab Injection + Oral Placebo followed by Oral Placebo, the Oral Placebo is taken together with Dupilumab from Day 1 until Week 16, then by itself to Week 20;
~In the arms Oral Placebo + Injectable Placebo followed by 100 mg PF-04965842 and Oral Placebo + Injectable Placebo followed by 200 mg PF-04965842, subjects, take Oral Placebo from Day 1 until Week 16."
15890877|NCT03720470|Drug|Injectable Placebo|Two subcutaneous injections of Placebo (for Dupilumab) administered as a loading dose on Day 1 followed by one injection every other week (q2w) until Week 16.
15890878|NCT03720457|Drug|Human CD19 targeted T Cells Injection|Autologous genetically modified anti-CD19 CAR transduced T cells
15890879|NCT03720444|Other|MDT (mechanical diagnosis and therapy) method|The intervention consists of a first session to carry out an assessment, followed by 4 reassessment sessions
15890880|NCT03720431|Drug|TTAC-0001 and pembrolizumab combination|"Investigational product (IP): TTAC-0001 and Pembrolizumab (Merck, Keytruda®)
~Treatment groups: 3 dose levels
~Dose level 1 (optimal starting dose): TTAC-0001 12 mg/kg on D1, D8 and D15 + Pembrolizumab 200 mg on D1
~Dose level 2 (first escalation dose): TTAC-0001 16 mg/kg on D1, D8 and D15 + Pembrolizumab 200 mg on D1
~Dose level 0 (de-escalation dose): TTAC-0001 8 mg/kg on D1, D8 and D15 + Pembrolizumab 200 mg on D1
~Cycle: 3 weeks (21 days per cycle)"
15890881|NCT03720418|Drug|OXB-102|Neurosurgical delivery of OXB-102 (gene therapy) to the putamen
15890882|NCT03720418|Other|Imitation Surgical Procedure (ISP)|Participants randomized to the control group in Part B will receive an ISP
15890883|NCT03720392|Drug|FMT|FMT is a process utilizing microbial components which are the good, healthy bacteria that would otherwise naturally occur in the body.
15890884|NCT03720392|Drug|Placebo|a harmless pill, medicine, or procedure prescribed more for the psychological benefit to the patient than for any physiological effect.
15890885|NCT03720379|Device|Fluor Protector S|. All of the elements of a clinical trial and the varnish applications will be performed every three-month during one year: Changes in The Simplified Oral Hygiene Index (OHl-S), white spot carious lesion discovered at the initial assessment as invisible, visible and inactive, active, cavities), dmft and dmfs and their components, bite-wings and Diagnodent assessment will be scored at follow-up examinations.
15890886|NCT03720379|Device|Placebo|All of the elements of a clinical trial and the placebo applications will be performed every three-month during one year: Changes in The Simplified Oral Hygiene Index (OHl-S), white spot carious lesion discovered at the initial assessment as invisible, visible and inactive, active, cavities), dmft and dmfs and their components, bite-wings and Diagnodent assessment will be scored at follow-up examinations.
15890887|NCT03720366|Drug|enasidenib|enasidenib
15890888|NCT03720366|Drug|Arm 1 probes|caffeine, dextromethorphan, flurbiprofen, midazolam, and omeprazole
15890889|NCT03720366|Drug|Arm 2 Probes|digoxin and rosuvastatin
15890890|NCT03720366|Drug|Arm 3 probes|pioglitazone
15890891|NCT03720353|Drug|SAS2094AH and SAS2094BH|SAS2094AH and SAS2094BH for 7 days, preceded by SAS2094AL and SAS2094BH for 3 days.
15890892|NCT03720353|Drug|SAS2094AL and SAS2094BL|SAS2094AL and SAS2094BL for 10 days
15890893|NCT03720353|Drug|Placebo|Placebo for 10 days. Capsules will mimic active treatments.
15890894|NCT03720340|Drug|Recombinant Human Interleukin-11|Recombinant Human Interleukin-11 was administed through respiratory tract.
15890895|NCT03720340|Drug|Saline|saline was administed through respiratory tract
15890896|NCT03720327|Behavioral|Get FIT|The Get FIT arm includes use of a free commercially available smartphone application to track daily food intake for 3 months; use of a Fitbit activity tracker for 3 months; and one 45 minute behavioral counseling session to set personal goals and provide education by a health coach.
15890933|NCT03720054|Behavioral|MapTrek|Our objective is to report activity levels in our virtual environment to veterans, thereby encouraging them first, to walk more every day, and second, to maintain these new increased levels of physical activity. MapTrek will also motivate veterans to accumulate less sedentary time.
15890934|NCT03720054|Behavioral|Fitbit|Fitbit Only
15891005|NCT03719430|Drug|APX005M|APX005M is a CD40 agonistic monoclonal antibody 0.3 mg/kg IV day 1 (21 day cycles)
15899323|NCT03654833|Drug|Abemaciclib|CDK4/6 inhibitor
15890897|NCT03720327|Behavioral|Get FIT+|The Get FIT+ arm includes use of a free commercially available smartphone application to track daily food intake for 3 months; use of a Fitbit activity tracker for 3 months; one 45 minute behavioral counseling session to set personal goals and provide education by a health coach; and personalized text messaging for 3 months by a health coach. The health coach will have access to these participants' daily food and activity data through the smartphone application, and will monitor progress and send push-only text messages to participants in this group based on the participant's goals and progress in the areas of physical activity, nutrition, and weight loss.
15890898|NCT03720314|Other|NA observational study|observational study
15890899|NCT03720301|Procedure|Osteopathic Manipulation Treatment|"All techniques with patient supine and physician at head of the bed:
~Soft tissue massage to the posterior cervical musculature for approximately 1 minute
~Muscle energy to the muscles of neck extension approximately 1 minute
~Muscle energy to the Occipital Atlanto (OA) joint 1 minute
~Muscle energy to the jaw. Approximately 1 minute
~Occipital decompression approximately 1 minute
~With time remaining complete another round of soft tissue massage.
~Intraoperative techniques:
~Myofascial Steering wheel Technique
~Sibson's Fascia Release
~Occipital decompression"
15890900|NCT03720301|Procedure|Sham|"Sham protocol:
~Patients randomized into the sham arm of the study will undergo a controlled trial tested sham treatment that was shown to induce no statistical improvement in cervical pain or mobility with zero adverse effects with the subjects unable to tell the difference between sham and actual protocol treatment."
15890901|NCT03720288|Drug|Acetazolamide|Patient will follow the treatment according to inclusion sequence, receiving the corresponding number medication.
15890902|NCT03720288|Drug|Placebo|Patient will follow the treatment according to inclusion sequence, receiving the corresponding number medication.
15890903|NCT03720275|Genetic|Systematic screening of TTR mutations|The diagnosis of TTR-FAP requires genetic analysis using direct sequencing of TTR gene.The diagnosis of TTR-FAP will be performed using standard procedures following international recommendations, requiring genetic analysis of the TTR gene.
15890904|NCT03720262|Combination Product|Mesh reinforcement|Reinforcement of the abdominal wall with Ultrapro Advanced.
15890905|NCT03720262|Other|No reinforcement|Suturing the abdominal wall without mesh reinforcement
15890906|NCT03720249|Dietary Supplement|supplementation of compound nutrients|Betaine、 (6S)-5-methyltetrahydrofolic acid、vitamin B6、vitamin B12 and zinc per day orally for 12 weeks.
15890907|NCT03720249|Dietary Supplement|placebo control|The placebo is an excipient and the color, flavor, shape, taste and weight are same with the tablet of supplement.
15890908|NCT03720236|Procedure|Implant bed preparation protocol|This is the first surgical phase, we prepare the implant bed by using different increasing size drills.
15890909|NCT03720236|Procedure|Implant loading|This is the second phase, based on prosthetic procedures, to design the crown over the dental implant
15890910|NCT03720223|Drug|Liposomal Bupivacaine|20ml of Liposomal Bupivacaine 1.3% (13.3mg/mL)
15890911|NCT03720210|Device|RFA|Radiofrequency ablation of a portion of thyroid parenchyma to treat amiodarone-induced thyrotoxicosis
15890912|NCT03720197|Other|Online questionnaire - Phase 1|Draw an overall picture of the population with type 1 diabetes in Quebec in terms of demographics, diabetes treatment, hypoglycemia frequency and diabetes complications.
15890913|NCT03720197|Other|Online questionnaire - Phase 2|Characterize the causes, experience and consequences of hypoglycemia.
15890914|NCT03720197|Other|Online questionnaire - Phase 3|Collect information on diabetes and hypoglycemia treatment, hyperglycemia management, sleep habits, depression, physical activity and the benefits of technologies to reduce the frequency of hypoglycemia.
15890915|NCT03720197|Other|Food questionnaire|24-hour food recall questionnaire
15890916|NCT03720197|Other|Podometer|Participants will wear a podometer for 14 consecutives days
15890917|NCT03720197|Other|Waist circumference|Participants will be asked to measure their waist circumference
15890918|NCT03720197|Other|Blood and urine tests|Participants will be invited to send us their latests blood and urine test results.
15890919|NCT03720197|Other|List of medications|Participants will be invited to send us their list of medications
15890920|NCT03720184|Procedure|HAR|"HAR, the 6 steps procedure that results in 300ml of haemodilution. Step 0: Circuit is primed with 1000ml of crystalloid solution. Step 1: Venous line content is drained to the reservoir. Step 2: arterial srystalloid priming is displaced to the reservoir retrogradely by autologous blood. Step 3: Crystalloid priming is discarded to the collector bag. Step 4: An amount of 300ml of arterial blood is sequestered to the reservoir avoiding the mixture. Step 5: The centrifugal pump and the oxygenator are reprimed with autologous blood displacing the priming and GME to the collector bag. Step 6: CPB is initiated with a low haemodilution of 300ml.
~Available at: https://zenodo.org/record/4276132#.X7K8AchKgRk"
15890921|NCT03720171|Device|e-OPRA Implant System|Implantation of e-OPRA Implant System in lower limb to be used with amputation limb prosthesis
15890922|NCT03720158|Dietary Supplement|Omega 3 Group|Five mL of an Omega-3 highly concentrated substance (containing 2.25 g of EPA and 1.08 g of DHA) will be added daily to the standard enteral diet during the entire radiotherapy
15890923|NCT03720158|Dietary Supplement|Placebo or Control Group|Five mL of pigmented and flavored corn oil will be added daily to the standard enteral diet during the entire radiotherapy treatment period (from 5-7 weeks)
15890924|NCT03720145|Behavioral|Lifestyle Medicine|Lifestyle intervention including diet, sleep, exercise, relaxation and mindfulness
15890925|NCT03720132|Procedure|Extensive flushing of the port catheter|The port catheter will be flushed extensively with sodium chloride 0.9% before blood sampling. Blood sampling will occur through the central catheter and peripherally simultaneously.
15890926|NCT03720119|Drug|Lidocaine Hydrochloride|As per clinical practice, a local treatment with ORTODERMINA® over a 14-day period (once a day) was prescribed. ORTODERMINA® contains 5% of lidocaine hydrochloride.
15890927|NCT03720106|Other|GOAL therapy plan|The GOAL algorithm designs a therapy plan based on the LIMOS assessment, patient goals and subject-specific treatment pathways. The adherence of this therapy plan is examined.
15890928|NCT03720080|Device|OpenAPS|A self-constructed OpenAPS system will be worn contemporaneously to a Medtronic Minimed 670G hybrid closed loop system. Both systems will calculate recommended basal rate insulin adjustments but only the Minimed 670G system will inject insulin. The maximum treatment period will be 2 weeks per patient
15890929|NCT03720067|Drug|Propranolol|40mg to 320mg / day
15890935|NCT03720041|Drug|R1: Ixazomib, Lenalidomide, Dexamethasone (IRD) induction therapy - reactive arm|"In the reactive arm at Randomisation 1, participants will receive IRD induction therapy with standard up-front dosing, with toxicity assessed at each cycle and doses adjusted in accordance with the guidelines given in the trial protocol. All participants will be given the following starting doses:
~Ixazomib: 4mg/day on days 1, 8 and 15, taken orally
~Lenalidomide: 25mg/day on days 1-21, taken orally
~Dexamethasone: 40mg on days 1, 8, 15 and 22 for participants aged ≤75 years, or 20mg on days 1, 8, 15 and 22 for participants aged > 75 years; taken orally
~Participants will receive this dosing regimen for 12 cycles of induction treatment, in the absence of disease progression or unacceptable toxicity. Each cycle is 28 days."
15890936|NCT03720041|Drug|R1: Ixazomib, Lenalidomide, Dexamethasone (IRD) induction therapy - adaptive arm|"In the adaptive arm at Randomisation 1, participants will receive IRD induction therapy with up-front dose reductions adjusted according to their frailty score: fit, unfit, or frail. The starting doses for each frailty category are described below:
~Fit category:
~Ixazomib: 4mg/day on days 1, 8 and 15, taken orally Lenalidomide: 25mg on days 1-21, taken orally Dexamethasone: 40mg on days 1, 8, 15 and 22, taken orally
~Unfit category:
~Ixazomib: 4mg/day on days 1, 8 and 15, taken orally Lenalidomide: 15mg on days 1-21, taken orally Dexamethasone: 20mg on days 1, 8, 15 and 22, taken orally
~Frail category:
~Ixazomib: 4mg/day on days 1, 8 and 15, taken orally Lenalidomide: 10mg on days 1-21, taken orally Dexamethasone: 10mg on days 1, 8, 15 and 22, taken orally
~Participants will receive this dosing regimen for 12 cycles of induction treatment, in the absence of disease progression or unacceptable toxicity. Each cycle is 28 days."
15890937|NCT03720041|Drug|R2: Lenalidomide plus placebo maintenance|"Participants randomised to receive lenalidomide plus placebo maintenance at Randomisation 2 will receive the following starting doses:
~Lenalidomide: 10mg*/day on days 1-21, taken orally Placebo: 4mg*/day on days 1, 8 and 15
~* or final dose administered at the end of induction treatment if lower.
~This dosing regimen is continued for every maintenance cycle. Participants will continue maintenance treatment until disease progression or intolerance/unacceptable toxicity. Each maintenance cycle is 28 days.
~Randomisation 2 is double-blind - participants and their treating clinicians will be blinded to maintenance allocation."
15890938|NCT03720041|Drug|R2: Lenalidomide + ixazomib maintenance|"Participants randomised to receive lenalidomide plus ixazomib maintenance at Randomisation 2 will receive the following starting doses:
~Lenalidomide: 10mg*/day on days 1-21, taken orally Ixazomib: 4mg*/day on days 1, 8 and 15
~* or final dose administered at the end of induction treatment if lower.
~This dosing regimen is continued for every maintenance cycle. Participants will continue maintenance treatment until disease progression or intolerance/unacceptable toxicity. Each maintenance cycle is 28 days.
~Randomisation 2 is double-blind - participants and their treating clinicians will be blinded to maintenance allocation."
15890939|NCT03720028|Behavioral|Observation|Describe communication and sensory profile using standardized tests and observations.
15890940|NCT03720028|Behavioral|Parental experiences|Survey parents' experiences with parent-child interaction and augmentative and alternative communication.
15890941|NCT03720015|Behavioral|Physical exercise|Physical exercise controlled program supervised by an accredited exercise specialist
15890942|NCT03720015|Dietary Supplement|Nutritional management|Nutritional management controlled by a PhD clinical and sport nutrition specialist
15890943|NCT03720002|Dietary Supplement|HF2|placebo
15890944|NCT03719989|Drug|azacitidine plus R-GDP|azacitidine S.C 25 mg/m2 D1,2,3,4,5 rituximab I.V. 375 mg/m2 D8 gemcitabine I.V. 1,000 mg/m2, D8,15 dexamethasone I.V. or P.O. 40 mg D8,9,10,11 every 21 days, up to 6 cycles
15890945|NCT03719976|Other|Group-based educational intervention|The group-based educational intervention will use a bilingual Community Health Worker (CHW) who will teach parents key skills needed to access health care for children. Parents will be invited to attend 6 small, closed-group sessions held over 12 weeks and lasting no more than 75 minutes. Sessions will be interactive, culturally-appropriate, and held in parents' preferred language.
15890946|NCT03719963|Device|Cochlear implant|Cochlear implant for hearing process by surgical intervention
15890947|NCT03719937|Device|weight on the anterior chest of the patient|The investigators aim at assessing whether and to what extent an artificial increase in chest wall elastance, while the patient is in the supine position, may yield a significant benefit to oxygenation. The increase in chest wall elastance will be will be achieved placing a 100 g/kg weight on the anterior chest wall of the patient while he/she is in the supine/semirecumbant position. The weights will be placed on the patients' chest for 120 minutes, and then removed. A number of measurements will be recorded before and after the procedure.
15890948|NCT03719924|Drug|Onivyde|onivyde will be administered first, followed by folinic acid or L-folinic acid and then 5-FU at D1 and D14.
15890949|NCT03719924|Drug|Paclitaxel|Paclitaxel : 80 mg/m2 IV during 60 minutes at D1, D8 and D15
15890950|NCT03719911|Behavioral|Live diabetes coaching program|Live diabetes coaching program
15890951|NCT03719898|Drug|Brigatinib|Brigatininb is administered in tablet form. It is to be taken until disease progression, unacceptable toxicity or completion of 24 cycles. patients may continue to take brigatininb beyond 24 cycles if they are benefiting from the drug
15890952|NCT03719885|Device|TrueTear Intranasal Tear Neurostimulator|This study will evaluate the immediate tear production resulting from use of intranasal tear neurostimulation in patients with Sjogren's disease
15890953|NCT03719872|Diagnostic Test|Pre-Operative Transabdominal Ultrasound|Pre-Operative Transabdominal Ultrasound evaluation of the right upper quadrant of the abdomen. Examination with be performed with low frequency curvilinear transducer and high frequency linear transducer at 5 standardized locations along the right costal margin followed by a 10 second sweep along the costal margin from the xyphoid process to the mid-axillary line
15890954|NCT03719872|Diagnostic Test|Post-Operative Transabdominal Ultrasound|Post-Operative Transabdominal Ultrasound evaluation of the right upper quadrant of the abdomen. Examination with be performed with low frequency curvilinear transducer and high frequency linear transducer at 5 standardized locations along the right costal margin followed by a 10 second sweep along the costal margin from the xyphoid process to the mid-axillary line
15890998|NCT03719521|Other|Community-based package of integrated HIV, SRH and general health services|HIV Testing and Counselling, SRH and HIV prevention Services and General Health Counselling for all 16-24 year olds and ART initiation and ongoing treatment and adherence support for those who test HIV positive
15890999|NCT03719482|Drug|[18F]MNI-1054|Healthy Volunteers recruited for the study will undergo a single [18F]MNI-1054 injection and PET scan.
15890955|NCT03719859|Other|Physical Therapy|"Subjects who will participate in the physical therapy intervention group will attend therapy 4-6 days after discharge from the hospital, and continue in therapy approximately once a week for three months. The physical therapy progression will follow the standard of care developed at Duke Sports Medicine Physical Therapy for rehabilitation following RSA. Some of the patients in the PT intervention cohort may have physical therapy at an institution outside of Midwest Orthopaedics at Rush. All patients, whether in the Rush system or outside, will be given a prescription with the identical instructions for physical therapy, status post (R/L) reverse total shoulder arthroplasty, 1-2 x per week x 12 weeks."
15890956|NCT03719859|Other|Home Therapy|The surgeon/Nurse Practitioner/Physician Assistant will advance rehabilitation exercises and activity guidelines at customary scheduled postoperative appointments for this surgical procedure: 2 weeks (+/- 5 days), 6 weeks (+/- 1 week), 3 months and 6 months (+/- 1 month), and 1 and 2 years (+/- 2 months).
15890957|NCT03719820|Drug|aggressive medical management|Aspirin (100 mg daily) and Clopidogrel (75 mg daily) for 3 months and Rosuvastatin (20mg daily) for at least 6 months as well as traditional risk factors management
15890958|NCT03719807|Other|Rehabilitation protocol|A physiotherapy rehabilitation protocol - comprising of pragmatic exercises.
15890959|NCT03719807|Other|Usual Care|No routine outpatient physiotherapy. Normal inpatient physiotherapy to match intervention group.
15890960|NCT03719794|Dietary Supplement|Probiotic supplement|Probiotic supplement once daily (xyz) for 12 weeks
15890961|NCT03719794|Dietary Supplement|Placebo supplement|Placebo supplement once daily for 12 weeks
15890962|NCT03719781|Diagnostic Test|standardized minimental testing|To diagnose postoperative cognitive dysfunction
15890963|NCT03719768|Drug|Avelumab|Patients will be given 800 mg Avelumab as a one hour intravenous infusion once every 2 weeks.
15890964|NCT03719768|Radiation|Whole Brain Radiotherapy|Patients will be given 3000 cGy Whole Brain Radiotherapy once every 2 weeks
15890965|NCT03719755|Procedure|50% dextrose|maximum injection of 40 cc of 50% dextrose plus 300 cc of normal saline washout versus normal saline after hysterectomy for benign indications.
15890966|NCT03719755|Procedure|Normal Saline|Cystoscopic distention media of normal saline
15890967|NCT03719742|Other|Sponsor Test Products|Baby Bee Foaming Cleanser(at least once daily but not more than twice daily), BB Baby Ultra Gentle Lotion (Once immediately after cleansing and again approximately 10-12 hours after cleansing)
15890968|NCT03719729|Drug|Rifaximin|Administer daily rifaximin to modify intestinal microbiome to alter the course of the disease.
15890969|NCT03719716|Other|Anticipatory care planning letter|Patient letter to take to GP and GP literature
15890970|NCT03719690|Drug|Tipifarnib|Tablet for oral administration
15890971|NCT03719690|Device|HRAS Detection Assay|In Vitro Assay to detect HRAS mutations
15890972|NCT03719677|Behavioral|Habit development intervention|Lifestyle behavior change intervention targeting physical activity and dietary habit development as well as improving physical and social functioning
15890973|NCT03719664|Drug|Albuvirtide|Intravenous infusion of Albuvirtide
15890974|NCT03719664|Drug|3BNC117|Intravenous infusion of 3BNC117
15890975|NCT03719664|Drug|Baseline ART|Subjects continuing on baseline ART
15890976|NCT03719651|Behavioral|LOCI|LOCI includes training of leaders in general leadership, implementation leadership, and implementation climate.
15890977|NCT03719651|Behavioral|EMDR|EMDR (Eye Movement and Desensitization Reprocessing), treatment method developed for treating patients with Post-Traumatic Stress Symptoms (PTSD).
15890978|NCT03719651|Behavioral|CT-PTSD|CT-PTSD (Cognitive Therapy for PTSD), treatment method developed for treating patients with Post-Traumatic Stress Symptoms (PTSD).
15890979|NCT03719651|Behavioral|TF-CBT|TF-CBT (Trauma-Focused Cognitive-Behavioral Treatment) treatment method developed for treating patients with Post-Traumatic Stress Symptoms (PTSD).
15890980|NCT03719638|Device|D-blade of videolaryngoscope|intubation will be done using d-blade of videolaryngoscope
15890981|NCT03719638|Other|simulated difficult airway|extension of head will be limited by using collar.
15890982|NCT03719638|Device|Macintosh videolaryngoscope|intubation will be done using macintosh videolaryngoscope
15890983|NCT03719625|Drug|Ephedrine|Comparaison of Norepinephrin and Ephedrin for prevention of the post spinal anesthesia in cesarean section
15890984|NCT03719625|Drug|Norepinephrine|Comparaison of Norepinephrin and Ephedrin for prevention of the post spinal anesthesia in cesarean section
15890985|NCT03719612|Drug|DEFINITY®|All subjects will receive a single dose of DEFINITY®
15890986|NCT03719586|Drug|ZMapp|Three doses of 50 mg/kg of body weight administered intravenously every third day beginning on Day 1
15890987|NCT03719586|Drug|Remdesivir|Administered intravenously with a loading dose on Day 1 (200 mg for adults and pediatric patients with body weight >= 40 kg and for pediatric patients weighing < 40 kg one loading dose of remdesivir 5 mg/kg) followed by 9 to 13 days of once-daily maintenance dosing starting on Day 2 and extending through Day 10 to 14 (100 mg for adults and pediatric patients with body weight >= 40 kg and for pediatric patients weighing < 40 kg remdesivir 2.5 mg/kg)
15890988|NCT03719586|Drug|MAb114|50 mg/kg of body weight administered intravenously on Day 1 as a single infusion
15890989|NCT03719586|Drug|REGN-EB3|150 mg/kg of body weight administered intravenously on Day 1 as a single infusion
15890990|NCT03719573|Other|Geriatric intervention|A comprehensive geriatric assessment (CGA), focusing on co-morbidity, medication, cognitive status, depression, nutritional status and physical status is performed. The intervention is individualized according to the results of the CGA.
15890991|NCT03719560|Drug|Methotrexate|Systemic methotrexate
15890992|NCT03719560|Drug|Cytarabine|Systemic cytarabine
15890993|NCT03719547|Procedure|Abdominal radical hysterectomy|Radical hysterectomy (type B or C according to the Querleu&Morrow classification) with pelvic lymphadenectomy
15890994|NCT03719547|Procedure|Robot-assisted radical hysterectomy|Radical hysterectomy (type B or C according to the Querleu&Morrow classification) with pelvic lymphadenectomy
15890995|NCT03719547|Diagnostic Test|Sentinel lymph node biopsy|Assessment of sentinel lymph nodes using either radiotracer or indocyanine green (ICG)
15890996|NCT03719534|Procedure|haplo-SCT|SCT will be performed with a haplo-identical donor
15890997|NCT03719534|Procedure|haplo-cord SCT|Haplo-identical donor SCT will be performed with co-infusion of unrelated cord blood unit
15891006|NCT03719417|Procedure|Unicompartmental Biologic Arthroplasty|Unicompartmental Biologic Arthroplasty surgery.
15891007|NCT03719417|Procedure|Extensive Biologic Arthroplasty|Unicompartmental Biologic Arthroplasty surgery with an additional surface being replaced concurrently
15891008|NCT03719404|Procedure|sodium hypochlorite|sodium hypochlorite is used as primary irrigant and edta is used as secondary irrigant in endodontic retreatment cases
15891009|NCT03719404|Procedure|chlorhexidine|Chlorhexidine is used as primary irrigant and citric acid is used as secondary irrigant in endodontic retreatment cases
15891010|NCT03719391|Other|Virginia Tobacco flavored JUUL 5% ENDS|Treatment with Virginia Tobacco flavored JUUL 5% ENDS (10 puffs).
15891011|NCT03719391|Other|Cool Mint flavored JUUL 5% ENDS|Treatment with Cool Mint flavored JUUL 5% ENDS (10 puffs).
15891012|NCT03719391|Other|Mango flavored JUUL 5% ENDS|Treatment with Mango flavored JUUL 5% ENDS (10 puffs).
15891013|NCT03719391|Other|Creme Brulee flavored JUUL 5% ENDS|Treatment with Creme Brulee flavored JUUL 5% ENDS (10 puffs).
15891014|NCT03719391|Other|VUSE Solo e-cigarette|Treatment with VUSE Solo Original with 4.8% nicotine e-cigarette (10 puffs).
15891015|NCT03719391|Other|Nicorette White Ice Mint 4mg nicotine polacrilex gum|Treatment with Nicorette White Ice Mint 4mg Nicotine polacrilex gum (30 minutes Chew and Park method)
15891016|NCT03719391|Other|Usual Brand combustible cigarette|Treatment with usual brand cigarette (10 puffs).
15891017|NCT03719378|Other|Pre Operative Oral Fluids|Patients will be self hydrating prior to their total knee replacement.
15891018|NCT03719365|Device|NAVAPSV|During the first trial, PSV will be set in order to obtain a Vt between 6 and 8 ml/kg; this support level will be defined as PSV100. Subsequently, the corresponding NAVA level (NAVA 100) will be determined using a dedicated ventilator function (NAVA Preview) which is able to estimate NAVA level in order to deliver an equivalent inspiratory peak pressure (Paw peak) compared to that obtained during PSV mode. Afterwards, PSV100 and NAVA100 will be first increased (PSV150 and NAVA150) during the second trial and then decreased during the third trial (PSV50 and NAVA150) by 50% from basal value. During the study period, PEEP and FiO2 will be kept equal to the values in use before patient enrollment.
15891019|NCT03719352|Procedure|Experimental: Deep dry needling|Deep dry needling until achieving twitch response of the muscle
15891020|NCT03719352|Procedure|Experimental: Superficial dry needling|Superficial dry needling to achieve sensitive pain with needle rotation
15891021|NCT03719352|Procedure|Placebo Comparator: Placebo Gastrocnemius dry needling|Simulate pain with de plastic needle guard in the gastrocnemius muscle
15891022|NCT03719326|Drug|Etrumadenant|Etrumadenant is an A2aR and A2bR antagonist for oral use
15891023|NCT03719326|Drug|IPI-549|IPI-549 is a phosphoinositide-3-kinase-gamma inhibitor for oral use
15891024|NCT03719326|Drug|Pegylated liposomal doxorubicin (PLD)|Doxil is an anthracycline topoisomerase II inhibitor that is encapsulated in liposomes for intravenous (IV) use
15891025|NCT03719326|Drug|nanoparticle albumin-bound paclitaxel (NP)|NP is a microtubule inhibitor for intravenous (IV) use
15891026|NCT03719313|Drug|Lonafarnib|Lonafarnib (LNF) 50 mg BID
15891027|NCT03719313|Drug|Ritonavir|Ritonavir (RTV) 100 mg BID
15891028|NCT03719313|Drug|PEG IFN-alfa-2a|PEG IFN alfa-2a 180 mcg QW
15891029|NCT03719313|Drug|Placebo Lonafarnib|Placebo
15891030|NCT03719313|Drug|Placebo Ritonavir|Placebo
15891031|NCT03719300|Drug|inodiftagene vixteplasmid|"BC-819 at 20 mg/50 mL, instilled intravesically into the bladder, with a retention time of at least 30 minutes (up to 2 hours).
~Induction Phase (weekly treatments): 10 weekly treatments; Maintenance Phase: treatment every 3 weeks for up to 84 additional weeks"
15891032|NCT03719274|Dietary Supplement|vitamin c depigementation|locally injected vitamin c depigementation
15891033|NCT03719261|Drug|chitosan nanoparticles|Chitosan is a bioactive polymer obtained from deacetylation of chitin and is used in biomedical application due to its antimicrobial properties and biocompatibility and ability to resist aging for longer periods provide antibacterial effect in root canal disinfection.10ml of cs-np will be used during instrumentation in intervention group
15891034|NCT03719261|Drug|Sodium Hypochlorite|Sodium hypochlorite (NaOCL) is the most recommended irrigant due to its broad antibacterial effect, necrotic tissues and dentin collagen dissolving capability and inactivation of endotoxins.10ml of 2.5%NaOCL will be used during instrumentation in control group
15891035|NCT03719248|Device|thoracic epidural|high thoracic epidural anesthesia (HTEA) combined with GA, transesophageal, transthoracic echocardiography and Holter ECG
15891036|NCT03719235|Other|CBCT|ultra-low dose CBCT
15891037|NCT03719222|Other|non intervention|It is an non-interventional retrospective observational study by using archived paraffin-embedded tumor specimens
15891038|NCT03719209|Other|HealthVoyager|HealthVoyager is a virtual reality application that allows providers to create customized representations for patients and share the results of endoscopic procedures via an interactive platform. The app can show both normal and abnormal endoscopic findings and anatomy. Families will also receive a web link so that they may access the procedure results via the app at home on their smartphone or tablet.
15891039|NCT03719209|Other|Standard Practice|Patients and families will receive handouts with printed images of their endoscopic findings, as per standard practice at Boston Children's Hospital.
15891040|NCT03719196|Other|Reading glass|Participants from the experimental group have received reading glasses free of cost. Investigators hypothesize that a simple pair of eyeglasses could improve the lives of these people by enabling continued participation in the workforce, restoring productivity levels in both paid and unpaid work, and enhancing the ability to perform everyday tasks. Investigators also hypothesize that reading glasses will improve quality of life.
15891041|NCT03719183|Diagnostic Test|Conventional Cytogenetics Studies|Metaphase cytogenetic studies will be performed in all cases according to standard methods. Chromosome preparations will be G-banded using trypsin and Giemsa, and karyotypes will be described according to the International System for Human Cytogenetic Nomenclature (ISCN) 2016.
15891042|NCT03719183|Diagnostic Test|Fluorescent in Situ Hybridization (FISH) Panels|"AML Panel includes:
~t(8;21) (RUNX1-RUNX1T1).
~inv(16), t(16;16) (CBFB-MYH11).
~t(9;22) (BCR-ABL).
~11q23 KMT2A rearrangements.
~inv(3) MECOM rearrangements.
~NUP214 rearrangements.
~Acute Promyelocytic Leukemia panel includes:
~t(15;17) (PML-RARA).
~17q RARA rearrangements"
15891043|NCT03719183|Diagnostic Test|Multiplex FISH (M-FISH)|24-color karyotyping
15903098|NCT03625453|Drug|Placebo|Part 1: 8 weeks with daily administration
15891044|NCT03719170|Behavioral|PPI De-prescribing Program|The PPI de-prescribing program includes alerts to clinical pharmacy specialists and primary care providers informing them of individual patients scheduled for upcoming primary care visits who meet criteria for PPI de-prescription; activation of clinical pharmacy specialists; education of primary care providers; and patient education.
15891045|NCT03719157|Procedure|Unilateral ESP Block|USG guided ESP block will perform unilateral with Bupivacaine and Lidocain mixture
15891046|NCT03719157|Procedure|Unilateral OSTAP Block|USG guided OSTAP block will perform unilateral with Bupivacaine and Lidocain mixture
15891047|NCT03719157|Procedure|Injection of Local Anesthetic to Trocar Insertion|Bupivacaine infiltration will be performed at the end of the surgical procedure to trocar insertion sites.
15891048|NCT03719157|Drug|intravenous patient controlled analgesia|All patients were followed using a standardized postoperative analgesia protocol which includes tramadol PCA. Tramadol at a concentration of 5 mg/mL is included in our PCA protocol (total volume 100 mL.) PCAs were set to no basal infusion and 10 mg bolus doses with a 20 min lock time.
15891049|NCT03719131|Drug|Nivolumab|Receive standard of care nivolumab therapy
15891050|NCT03719131|Biological|Rituximab and Hyaluronidase Human|Given IV or SC
15891051|NCT03719131|Drug|Ipilimumab|Receive standard of care ipilimumab therapy
15891052|NCT03719118|Genetic|genotyping for three genes (TPMT, NUDT15 and FTO)|Patients who carry any heterozygotic variants receive 50 mg AZA or 25 mg 6-mercaptopurine (6-MP), while those who have any homozygotic variants are recommended to take other alternative drugs instead of thiopurines
15891053|NCT03719118|Other|non-genotyping|Patients receive standard doses of thiopurines based on the conventional regimen without pretreatment genotyping. Conventional regimen starts with 50 mg of AZA, then the dose is increased by 25 mg in every 1-2 weeks to 2.0-2.5 mg/kg along with regular monitoring of general blood tests including WBC counts.
15891054|NCT03719105|Drug|Methotrexate|Patients will receive methotrexate as part of chemoimmunotherapy regemin followed by allogeneic stem cell transplant.
15891055|NCT03719105|Drug|pralatraxate,|Patients will receive pralaxtraxate as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
15891056|NCT03719105|Drug|Ifosfamide|Patients will receive Ifsofamide as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
15891057|NCT03719105|Drug|Dexamethasone|Patients will receive dexamethasone as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
15891058|NCT03719105|Drug|Etoposide|Patients will receive etoposide as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
15891059|NCT03719105|Drug|calaspargase pegol|Patients will receive pegaspargase as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
15891060|NCT03719105|Drug|cyclophosphamide|Patients will receive cyclophosphamide as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
15891061|NCT03719105|Drug|Doxorubicin|Patients will receive doxorubicin as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
15891062|NCT03719105|Drug|Prednisone|Patients will receive prednisone as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
15891063|NCT03719105|Drug|Brentuximab Vedotin|Patients will receive brentuximab vedotin as part of chemoimmunotherapy regimen followed by allogeneic stem cell transplant.
15891064|NCT03719092|Dietary Supplement|Vitamin A Compound|Given PO or enterally
15891065|NCT03719079|Device|SimpleSENSE|The Nanosense study is observational only. No interventions will be triggered by the SimpleSense device
15891066|NCT03719066|Biological|killed whole cell oral cholera vaccine|two week interval
15891067|NCT03719053|Drug|Tenofovir|pre- and post-dosing measurements of TFV and TFV-DP in plasma and PBMCs.
15891068|NCT03719040|Device|Physiologic pacing device implant|An alternative and potentially more effective pacing strategy for patients with electrical conduction abnormalities is physiologic pacing. Physiologic pacing is achieved by delivering a pacing stimulus to a cardiac conduction structure, such as the bundle of His or left bundle branch (LBB) of the His-Purkinje system, with a permanent lead. Physiologic pacing activates the heart through the native His-Purkinje conduction system, thus offering the most physiologic pacing approach to correct electrical dyssynchrony. Physiologic pacing has emerged as a feasible and safe alternative to pacemaker therapy and CRT with clinical and electrophysiological advantages.
15891069|NCT03719027|Diagnostic Test|Study population|Dyspnea assessment (NYHA functional class) EKG Echocardiography
15891070|NCT03719014|Device|NovaCross|The NovaCross micro-catheter will be used during a standard of care Percutanous Coronary Intervention (PCI) on subjects diagnosed with at least one coronary chronic total occlusion (CTO), in order to assist the operator in guidewire stability and centralization.
15891071|NCT03719001|Drug|Phenylephrine|blood pressure will be increased or decreased by using one of six interventions: phenylephrine (alpha-1 agonist), dexmedetomidine (alpha-2 agonist), clevidipine (Ca channel blocker, CaCl, tetanic stimulus and increase in venous pressure
15891072|NCT03719001|Drug|Dexmedetomidine|blood pressure will be increased or decreased by using one of six interventions: phenylephrine (alpha-1 agonist), dexmedetomidine (alpha-2 agonist), clevidipine (Ca
15891073|NCT03719001|Drug|Clevidipine|blood pressure will be increased or decreased by using one of six interventions: phenylephrine (alpha-1 agonist), dexmedetomidine (alpha-2 agonist), clevidipine (Ca
15891074|NCT03719001|Other|tetanic stimulus|A 5 second 70 mA tetanic stimulus will be applied to elicit peripheral vasoconstriction (stress response)
15891075|NCT03719001|Other|Increased venous pressure|A 5 minute inflation of a noninvasive blood pressure cuff to 30 mmHg to increase venous pressure in the arm with the pulse oximeter probes.
15891076|NCT03719001|Drug|Calcium Chloride|CaCl will be administered to increase blood pressure and plasma calcium concentration
15891077|NCT03718988|Behavioral|Meat products|Traditional meat products (beef burger patties, pork sausage, etc.)
15891078|NCT03718988|Behavioral|Plant Alternative products|Plant-based alternatives (The Beyond Burger, Beyond Sausage, etc.)
15891079|NCT03718975|Device|Successor of Phonak Audéo B90|Successor of the most recent Receiver in the canal (RIC) Hearing aid form Phonak which will be fitted to the participants individual Hearing loss.
15891080|NCT03718975|Device|Phonak Audéo B90|The Phonak Audéo B90 is the most recent Receiver-in-the-canal Hearing aid from Phonak which will be fitted to the participants individual Hearing loss.
15891083|NCT03718897|Diagnostic Test|Endoscopic retrograde cholangiopancreatogram|Biopsy specimens are attained via endoscopic retrograde cholangiopancreatogram in patients with suspicious biliary tract cancer.
15891084|NCT03718884|Drug|Drug Cocktail|Drug cocktail consists of caffeine, warfarin plus vitamin K, omeprazole, dextromethorphan, and midazolam, administered orally
15891085|NCT03718884|Drug|Mirikizumab|Administered SC
15891086|NCT03718871|Behavioral|HIV testing at traditional healer practices|HIV 1/2 antigen-antibody POC test (Oraquick©) will be administered to those participants who agree to test. Pre-test counseling will be performed before results are delivered. Clients with positive tests will be provided with detailed contact information for the MUST ISS clinic, and given specific instructions to present to the clinic as soon as possible for confirmatory testing and linkage to care.
15891087|NCT03718858|Procedure|Interscalene Block|15 mL ropivacaine 0.5% will be injected in 5 mL aliquots in order to achieve spread adjacent to C5 and C6 nerve roots.
15891088|NCT03718858|Procedure|Superior Trunk Nerve Block|15 mL ropivacaine 0.5% will be injected in 5 mL aliquots in order to achieve spread adjacent to Superior Trunk Nerve.
15891089|NCT03718845|Behavioral|Mind-Body Medicine Curriculum|The Mind-Body Medicine curriculum consists of presentations on different mind-body techniques as well as the research supporting the use of these techniques.The mind-body technique is then practiced in a supportive small group setting. Mind-body techniques will include guided imagery, relaxation techniques, several forms of meditation, autogenic training and biofeedback.
15891090|NCT03718832|Other|Fresh Food Farmacy|Patients are prescribed fresh food by a dietician, fill the prescription each week at the FFF clinic, receive training on how to use the food, and training in diabetes self management.
15891091|NCT03718819|Other|exercise|Pilates and aquaplyometric exercises will be done combinedly.
15891092|NCT03718806|Drug|Zoliflodacin|oral suspension; oral administration
15891093|NCT03718806|Other|high calorie, high fat breakfast|fasted/fed conditions
15891095|NCT03718780|Other|simultaneous determination of PaCO2 and PtCO2|"Patients in intensive care, equipped, for their routine clinical management, with an arterial catheter blood line, will have a simultaneous determination of PaCO2 and PtCO2:
~1) at rest; 2 arterial CO2/PtCO2 determinations will be carried out, 10 minutes apart
~2) During the muscular exercise part of their routine rehabilitation program (whatever it might be, limbs active mobilization, walking, etc...) : several arterial /PtCO2 samples will be collected during the first minutes of their muscular routine: 30 sec, 1 minute, 1 ½ minute, 2, 2 ½ , 3, 4, 5 minutes, 10 minutes (end of exercise). This will generate several couples of blood/transcutaneous CO2 determinations"
15891096|NCT03718780|Other|Hyperventilation test|Repeated pairs of PtCO2 and PaCO2 (through arterialized capillary sampling), will be measured at the following timing: rest (0), then 30 sec post beginning of hyperventilation (breathing with accelerated frequency e.g. 30/min), 1 minute, 1 ½ minute 2, 2 ½ , 3, , 4, 5 minutes; recovery of this hyperventilation will be followed, for 5 minutes, with the PtCO2, during 3 minutes
15891097|NCT03718780|Other|Exercise test|an exercise test, according to the routine protocol used in the clinic: initial phase of 3 minutes gentle pedaling (10 to 50 watts, according to subject capabilities), then stepwise increase in the workload, by increments of 20-40 watts every minute, until maximum tolerated workload (VO2max). Repeated pairs of PtCO2 and PaCO2 (through arterialized capillary sampling), will be measured at the following timing: rest -10 minutes, 0, then 30 sec post beginning of exercise, 1 minute, 1 ½ minute 2, 2 ½, 3 minutes, then 3 ½ minutes, then at mid-point of every step increase in workload, until maximum tolerated workload. Recovery will be followed with the PtCO2, for 5 minutes
15891098|NCT03718767|Drug|Nivolumab|Nivolumab is given IV as flat dose of 240 mg for Cycles 1-4 and 480 mg for Cycles 5-16.
15891099|NCT03718754|Device|En-Bloc TURB|En-bloc resection will be performed at each center based on local clinical practice and available instruments. Laser resection, hydrodissection with HybridKnife® or electric resection are allowed. All procedures, including cTURB, must be performed with an imaging enhancing technique (PDD / NBI at surgeon's discretion). After resection, a single intravesical instillation of 40mg Mitomycin-C will be performed if clinically feasible.
15891100|NCT03718754|Device|Conventional TURB|En-bloc resection will be performed at each center based on local clinical practice and available instruments. After resection, a single intravesical instillation of 40mg Mitomycin-C will be performed if clinically feasible.
15891101|NCT03718741|Radiation|Radiotherapy +/- CT|Adiuvant Radiotherapy +/- weekly cisplatin
15891102|NCT03718728|Behavioral|Mind&Life|Acceptance and mindfulness-based group intervention program.
15891103|NCT03718728|Behavioral|Standard|Personalized diet and physical exercise recommendations.
15891104|NCT03718715|Drug|Metformin|Receiving Metformin is no study intervention. The investigators have no influence on the Metformin treatment. All participants receive Metformin provided by the health care system. The individual case determine dose and frequency of the treatment as part of the usual therapy guidelines.
15891105|NCT03718702|Other|ePain|Electronic pain management programme (ePain)
15891106|NCT03718689|Device|Laser etching|Acid etching
15891107|NCT03718676|Procedure|Ferric sulphate|Teeth were pulpotomized with ferric sulphate in this group.
15891108|NCT03718676|Procedure|Ortho-MTA|Teeth were pulpotomized with Ortho-MTA in this group.
15891109|NCT03718676|Procedure|Retro-MTA|Teeth were pulpotomized with Retro-MTA in this group.
15891110|NCT03718663|Other|Physiotherapy-guided Evidence-based Exercise Therapy|Standardized supervised exercise therapy for 6-8 weeks (two times per week).
15891111|NCT03718663|Other|Part 2: Military training|Part 2: standardized military training for 6-8 weeks in Defence Command Denmark
15891112|NCT03718650|Drug|Pimonidazole|Patients will take a single dose of 0.5 g/m^2 (approximately 13 mg/kg) of oral pimonidazole HCI 16 to 24 hours prior to surgery.
15891113|NCT03718650|Procedure|Surgical Resection|Patients will undergo Pancreaticoduodenectomy or Whipple procedure, which involves the resection of the pancreatic head, duodenum, gallbladder, and a portion of the stomach, 16 to 24 hours after consuming oral pimonidazole.
15891114|NCT03718637|Biological|Smith & Nephew Bioinductive Implant|A bioinductive implant that is supposed to foster healthy tendon regrowth after surgery.
15891115|NCT03718637|Procedure|Lateral Epicondylectomy|This procedure is the standard of care for lateral epicondylitis patients who fail conservative treatment options.
15891116|NCT03718637|Radiation|Ultrasound Imaging|An ultrasound will be performed on each patient both preoperatively and at 6 months.
15891117|NCT03718624|Drug|apatinib|apatinib：500mg qd po, 28 days is a cycle. preoperative 2 cycles, 2 cycles after surgery.
15891118|NCT03718624|Drug|paclitaxel|Paclitaxel: intraperitoneal paclitaxel 20 mg/m2 and intravenous paclitaxel 50 mg/m2 on days 1 and 8 ，21 days is a cycle. preoperative 3 cycles, 3 cycles after surgery.
15891119|NCT03718624|Drug|S-1|S-1： According to the body surface area, BSA <1.25m2，40mg bid; 1.25m2≤BSA≤1.5m2，50mg bid; BSA >1.5m2, 60mg bid. Take the medicine twice daily for 2 weeks, then suspend for 1 week. preoperative 3 cycles, 3 cycles after surgery.
15891120|NCT03718611|Drug|BR9001|BR9001 is a test drug as generic
15891121|NCT03718611|Drug|BR900A|BR900A is a reference drug
15891122|NCT03718598|Behavioral|Tendon and Nerve Gliding Exercises|Tendon and Nerve Gliding Exercises: The tendon slip exercises used in this study were performed in five different positions, namely flexion, flat, hook, punch, table top and flat punch positions. Nerve-gliding exercises were performed by moving the fingers and wrists in six different positions, focusing on the median nerve consisting of all the disease grip, finger lengthening, wrist extension, thumb extension, forearm supination and gentle gentle gait. Instructions were given to make 10 sets of exercises in 3 sets, written and verbal, in order to have e exercises for all patient's tendons and nerves shifting exercises. Brochures were also provided explaining the exercises.
15891123|NCT03718585|Other|whole exome sequencing analysis|Collecting peripheral blood samples (2 ml) from subjects for whole exome sequencing
15891124|NCT03718572|Procedure|Laparoscopic cholecystectomy|Surgical removal of Gall bladder using laparoscopy
15891125|NCT03718559|Drug|Edoxaban|Taking edoxaban (Lixiana™, Daiichi-Sankyo Inc.) 60mg once daily. The dose of edoxaban will be reduced to 30mg once daily in patients with estimated creatinine clearance 15≤CrCL≤50mL/min by Cockcroft-Gault equation or weight is ≤60kg.
15891126|NCT03718559|Drug|Single Antiplatelet Agents|Type of antiplatelet agent is dependant upon the investigator's discretion, but aspirin 100mg once daily is recommended.
15891127|NCT03718533|Drug|Eltrombopag|50mg Film-coated tablet and 25mg Film-coated tablet for oral use administration
15891129|NCT03718507|Drug|Fentanyl|atropine (0.01-0.02 mg/kg i.v. bolus) and fentanyl (0.5-2 mcg/kg i.v. in 5 minutes)
15891130|NCT03718507|Drug|Sucrose 24% Oral Solution|0.5 ml given orally 2 minutes before LISA procedure
15891131|NCT03718494|Combination Product|F-18 AV-1451 PET|Participants will receive an intravenous bolus injection of approximately 370 MBq (10 mCi) of 18F- AV-1451. PET/CT image acquisition will include a low dose CT and then a 20-minute PET acquisition starting at 80 minutes after injection of 18F-T807 and will be performed as 4, 5-minute frames that will then be summed into one static frame. Serial frames will allow for adjustment in the case of patient motion.
15891132|NCT03718494|Combination Product|F-18 Florbetapir|Each participant will be injected with 10 mCi of 18F-Florbetapir (target dose 370 MBq, range 296 - 444 MBq). After a 25-minute uptake period, the patient will be positioned on the scanner bed with instructions to remain motionless. A helical CT image will be obtained at 50 minutes after injection of 18F-Florbetapir, followed by a 10-minute PET acquisition consisting of two 5-minute dynamic frames.
15891133|NCT03718481|Other|ARCP Process|One Annual Review of Competence Progression (ARCP) cycle. In the U.K., doctors, across all specialities, undergo an Annual Review of Competence Progression (ARCP) to evaluate performance during each training year and determine progression to the next year of training. Similar processes exist in the Republic of Ireland. The process and requirements for ARCP in the UK are specified in the Gold Guide, the Reference Guide for Postgraduate Specialty Training [1]. It defines ARCP as a formal process that uses evidence collected by trainees to review and record performance, demonstrate competencies achieved and inform decisions regarding progression in training
15891134|NCT03718468|Biological|GC FLU Quadrivalent|A single dose administration of GC FLU Quadrivalent will be through intramuscular injection.
15891135|NCT03718468|Biological|Fluarix Tetra|A single dose administration of Fluarix Tetra will be through intramuscular injection.
15891136|NCT03718455|Device|Axillary Magseed|The Magseed will replace the investigators' current clinical practice of using radioactive seeds in women receiving neoadjuvant chemotherapy.
15891137|NCT03718442|Device|PhotonBlade vs Bovie for lumpectomy shaved surgical margins|For each enrolled patient, six shaved margins will be obtained (superior, inferior, medial, lateral, anterior, and posterior). For each patient, electrocautery will be used to obtain 3 of the shaved margins, and PhotonBlade to obtain the other 3 shaved margins. Once the lumpectomy site shaved margins have been obtained, the shaved surgical margins will be evaluated by a pathologist whom is blinded in regards to the dissection device that was used for each margin. The pathologist will be evaluating each shaved margin and reporting the outcomes (qualitative severity and depth of thermal artifact)
15891138|NCT03718429|Drug|Rivaroxaban 2.5Mg Tablet|PD assessments will be conducted at 3 time points: i) baseline (while on standard of care antiplatelet therapy), ii) 7-10 days after adjunctive treatment with low dose rivaroxaban, and iii) 7-10 days after dropping aspirin.
15891139|NCT03718403|Drug|Theophylline|Theophylline will be given to maintain a peak level between 10-15 mcg/mL
15891140|NCT03718390|Drug|Formulation A|Formulation A (37/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
15891141|NCT03718390|Drug|Formulation B|Formulation B (46/40A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
15891142|NCT03718390|Drug|Formulation C|Formulation C (37/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
15891143|NCT03718390|Drug|Formulation D|Formulation D (46/50A) of LYN-PLT containing less than 300 mg sucrose within the extended release formulation
15891144|NCT03718390|Drug|Formulation E|Placebo Capsule containing microcrystalline cellulose
15891145|NCT03718390|Procedure|Endoscopy|Endoscopy at 2 hours post dosing
15891146|NCT03718390|Procedure|Magnetic Resonance Imaging|MRI will be performed on specified days according to protocol
15891147|NCT03718377|Procedure|Serratus plane block|The subjects were received serratus plane block in the regional-anesthesia unit out of operation room before induction of general anesthesia. And, video-assisted thoracic surgery was performed under balanced general anesthesia.
15891244|NCT03717636|Other|medical evaluation|return of medical evaluation after discharge
15891148|NCT03718377|Procedure|General anesthesia only|Video-assisted thoracic surgery was performed under balanced general anesthesia without serratus plane block
15891149|NCT03718364|Procedure|catheter-based ablation of atrial fibrillation (pulmonary vein isolation)|catheter-based ablation of atrial fibrillation (pulmonary vein isolation)
15891150|NCT03718351|Procedure|transanal endoscopic microsurgery|a TEM tube will be inserted in the rectum. With specialized instruments the adenoma will be dissected en bloc by a full thickness excision, after which the patient will be admitted to the hospital.
15891151|NCT03718351|Procedure|endoscopic submucosal dissection|an endoscope will be inserted into the rectum and the submucosa underneath the lesion will be injected with saline to lift the adenoma. With an endoscopic knife (Insulated Tip Knife, Olympus or Water Jet, Erbe) the lesion will be resected through the submucosal plane in an eb-bloc fashion, after which the patient will be observed for at least 24h in-hospital.
15891152|NCT03718338|Procedure|Evaluation|Undergo clinical evaluations
15891153|NCT03718338|Other|Quality-of-Life Assessment|Ancillary studies
15891156|NCT03718312|Procedure|clamping with pre-conditioning (PCl)|"PCI procedure: clamping of the supracellular thoracic aorta for 5 minutes followed by a 5-minutes de-clamping period.
~PCI procedure is repeated twice."
15891157|NCT03718299|Drug|Injections of tildrakizumab|given at Week 0, Week 4, Week 16, Week 28, Week 40 and Week 52
15891158|NCT03718286|Drug|Alirocumab|150 mg alirocumab administered prior to revascularization procedure, 2 weeks post-procedure and 4 weeks post-procedure.
15891159|NCT03718286|Other|Sham Control|Sham injection prior to revascularization procedure, 2 weeks post-procedure and 4 weeks post-procedure.
15891160|NCT03718273|Drug|Ivabradine|"Ivabradine 5 mg, twice a day the first month administered by mouth. If the tolerance is good, the dose will be increased to 7.5 mg on month 2 and will continue until the third month.
~Patients with 75 or more years of age will receive an initial dose of 2.5 mg / twice a day, which can be increased to 5 mg / twice a day in week 7 and to 7.5 mg in month 1 if the tolerance has been good"
15891161|NCT03718273|Drug|Digoxin|The initial dose will be based on whether there are factors such as age over 80 years, weight less than 60 kg and creatinine clearance <60ml / min, if there is no factor, the oral dose will be 0.25mg / 24h. If there are 2 factors, the dose will be 0.15 mg / 24 h. and if there are 2 or 3 factors, the dose will be 0.10 mg / 24 h.
15891162|NCT03718260|Diagnostic Test|[18F]-DCFPyL PET/ CT scan (PSMA PET)|Participants will undergo re-staging with [18F]-DCFPyL PET/CT Scan (PSMA PET).
15891163|NCT03718247|Other|Modified Atkins diet|High fat low carbohydrate diet.
15891164|NCT03718234|Drug|Subcutaneous hydrocortisone|Patients will be monitored and receive an interval bolus SQHC dosing regimen that more closely mimics cortisol, 17OHP and D4A circadian and ultradian rhythms than conventional oral HC dosing.
15891165|NCT03718234|Drug|Standard glucocorticoid therapy|Subjects in this arm will continue on standard oral hydrocortisone therapy
15891166|NCT03718221|Other|Usual Care FIT Screening Strategy|Patients in usual care neighborhoods will receive FIT kits randomly throughout the year.
15891167|NCT03718221|Other|GeoMail FIT Screening Strategy|Patients in treated neighborhoods will receive kits at the same time.
15891168|NCT03718208|Dietary Supplement|Paediatric Formula|Children will switch over to the low calorie paediatric feed. Intake diaries and tolerance diaries will be completed for one week.
15891169|NCT03718195|Other|Pediatric Formula|One week intake diary, one week tolerance diary, product intake
15891170|NCT03718182|Dietary Supplement|Cholecalciferol|vitamin D3 daily oral supplement
15891171|NCT03718169|Behavioral|questionnaires|Female smokers will be asked to complete a structured questionnaire at smoking hotspots. In addition, the smokers will respond to the same questionnaire at 6 months via telephone. The structured questionnaire will collect information related to their demographic characteristics and quitting behaviors, i.e. self-reported abstinence, smoking reduction and quit attempts.
15891172|NCT03718156|Other|PREPARED Trial Intervention|Nursing staff members will be trained to adjust the therapeutic nursing plans (TNP) for residents enrolled in the study, as follows: 1) by providing optimal stimulation (surveying the use of eyeglasses and hearing aids, the room lighting and space organization; orienting the resident to time and space; and stimulating the resident using familiar objects, photos, and life histories); and 2) by assessing the presence of 4 modifiable delirium risk factors (antipsychotic use, sensory impairment, restraint use, and dehydration) and taking specific actions once a given risk factor is identified. For instance, if physical restraints are used, the TNP will require that they are to be removed during care when a caregiver is present (nail care, feeding, and wound care).
15891173|NCT03718143|Drug|Combination AZD1775 with AraC|AZD1775 days 1-5 & 8-12 AraC days 1-5 & 8-12
15891174|NCT03718143|Drug|AZD1775 only|AZD1775 days 1-5 & 8-12
15891175|NCT03718130|Combination Product|Hantann virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intradermal Delivery (ID)|The HTNV vaccine will be administered using the ID TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroportation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
15891176|NCT03718130|Combination Product|Hantann virus vaccine (HTNV) - Using TriGrid Delivery System (TDS) for Intramuscular Delivery (IM)|The HTNV vaccine will be administered using the IM TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroportation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
15891177|NCT03718130|Combination Product|Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID)|The PUUV vaccine will be administered using the ID TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroportation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
15891205|NCT03717948|Other|BFR Exercise|Participants will exercise on a recumbent bike placed on a 45 degree incline (BFR).
15891206|NCT03717948|Other|CTL Exercise|Participants will exercise on a recumbent bike placed on flat ground (CTL).
15904428|NCT03615105|Drug|Busulfan|Busulfan (adult/ped dose)
15891178|NCT03718130|Combination Product|Puumala virus vaccine (PUUV) - Using the TriGrid Delivery System (TDS) for Intramuscular Delivery (IM)|The PUUV DNA vaccine will be administered using the IM TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroportation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
15891179|NCT03718130|Combination Product|Hantaan/Puumala (HTNV/PUUV) virus vaccines - Using the TriGrid Delivery System (TDS) for Intradermal Delivery (ID)|The HTNV and PUUV vaccines will be administered using the ID TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroportation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
15891180|NCT03718130|Combination Product|Hantaan/Puumala (HTNV/PUUV virus vaccines - Using the TriGrid Delivery System (TDS) for Intramusular Delivery (IM)|The HTNV and PUUV vaccines will be administered using the IM TriGrid™ Delivery System (TDS), which utilizes the in vivo application of electrical fields (electroportation) to enhance the intracellular delivery of agents of interest in a targeted region of tissue.
15891181|NCT03718104|Other|Pharmacokinetic analysis|Pharmacokinetic analysis of maternal blood, maternal urine, cord blood, infant blood and urine for dyads in the naltrexone group at various time points in the pregnancy, at delivery, and 4 weeks postpartum.
15891182|NCT03718104|Other|Safety and Efficacy|Examination of the safety and efficacy of naltrexone and comparison of outcomes with the buprenorphine/naloxone cohort. Outcomes examined will include: 1) maternal outcomes (relapse, retention in care, preterm labor); 2) fetal outcomes (growth, fetal anomalies, fetal distress, cortisol levels); and 3) infant outcomes (NAS, growth, neurodevelopment via NNNS exam at 4 weeks and Bayley exam at 12 months of age).
15891183|NCT03718104|Genetic|Genetic and epigenetic analysis|Maternal blood and saliva DNA samples will be genotyped for single nucleotide polymorphisms in the mu opioid receptor gene (OPRM1) to look for associations with effectiveness of NTX and BPH. In addition, DNA methylation levels in the OPRM1 promoter within maternal and infant saliva and placenta at delivery and 4 weeks postpartum will be examined. Lastly, we will compare genome-wide DNA methylation levels at delivery and 4 weeks postpartum in mother-infant dyads.
15891184|NCT03718104|Other|Breast milk analysis|Mothers in the naltrexone group will have their breast milk analyzed at 4 weeks post-delivery for naltrexone levels, with corresponding maternal and infant plasma levels.
15891185|NCT03718091|Drug|M6620|M6620 is a drug designed to inhibit the ATR enzyme. Inhibiting ATR may block how cancers repair their naturally damaged DNA, handle cancer cell stress, and maintain cancer cell life and health.
15891186|NCT03718078|Device|Confocal Laser Endomicroscopy|"The study is divided in two parts. For the two parts, patients will receive an intravenous injection of indocyanine green:
~Ex vivo study
~- Images/sequences of normal and abnormal hepatic tissues and surgical margins will be acquired on surgical specimens
~In vivo study - Intra-operative pCLE imaging will be performed on hepatic masses and surgical margins"
15891187|NCT03718065|Drug|Lofexidine|Lofexidine, sold under the brand name Lucemyra among others, is a medication historically used to treat high blood pressure, but more commonly used to help with the physical symptoms of opioid withdrawal. It is taken by mouth. It is an α2A adrenergic receptor agonist.
15891188|NCT03718065|Drug|Placebo|Placebo comparator.
15891189|NCT03718052|Procedure|Early valve surgery (EVS)|Early valve surgery (EVS) within 72 hours of randomization
15891190|NCT03718052|Procedure|Conventional Care|Conventional care according to the 2015 European guidelines.
15891191|NCT03718039|Drug|HTX-011|HTX-011; up to but not to exceed 2.1 mL, via instillation into the surgical site.
15891192|NCT03718039|Device|Luer Lock applicator|Applicator for instillation.
15891193|NCT03718039|Device|Vial access device|Device for withdrawal of drug product.
15891194|NCT03718039|Drug|aprepitant|Aprepitant; Three single doses of aprepitant will be administered orally presurgery, Day 2, and Day 3.
15891195|NCT03718026|Other|The timed 360° turn test|"The timed 360° turn test: Each participant turns around in place in a standing position for both sides.
~Berg Balance Scale: It has 14 items, each of which is scored from 0 (i.e, severely impaired balance) to 4 (i.e., no balance impairment).
~Timed Up and Go test: It requires individual to stand up from an armed chair, walk 3m, turn around, walk back to the armed chair, and sit down again.
~Functional Reach Test: It measures the maximum distance an individual is able to reach forward beyond arm's length in the standing position when maintaining a fixed base of support.
~One-leg stance test: Individuals were asked to stand on either their left or right leg.
~Four square step test: It requires an individual to step over obstacles in various directions including forward, backward, and sideways."
15891196|NCT03718013|Device|accelerated deep TMS|subjects treated with deep TMS twice a day (6-8 hours between two applications), during 2 weeks
15891197|NCT03718013|Device|standard deep TMS|standard deep TMS treatment: once a day, during 4 weeks
15891198|NCT03718000|Device|Daily self-weighing (DSW)|DSW was conducted using digital WiFi scales during the holiday season. Participants received electronic graphic feedback of their weight fluctuations immediately after weight measurement.
15891199|NCT03717987|Drug|Botulinum toxin type A|"Botulinum toxin type A will be injected in all patients at both sides into the Yonsei point, (3Units) the point that would target 3 muscles responsible for upper lip elevation during smiling, including the LLSAN, in a single injection. This landmark was identified as the center of a triangle formed by the convergence of the LLSAN, the LLS, and the Zminor muscles and is located 1 cm lateral to the ala horizontally and 3 cm above the lip line vertically in both men and women (Hwang et al. 2009) and (Nasr et al. 2015)."
15891200|NCT03717987|Dietary Supplement|Zinc supplementation|zinc supplementation will be given to patients in the intervention arm 4 days prior to Botulinum toxin type A injection
15891201|NCT03717974|Other|Telemedecine follow-up after an intervention at home of the mobile team|"After a first visit of the mobile team at home, patients are followed by telemedicine. Moreover, in case of pain, a specialized consultation by an algologist of La Sagesse will be realized."
15891202|NCT03717974|Other|Mobile team follow-up after an intervention at home of the mobile team|"After a first visit of the mobile team at home, patients are followed by mobile team. Moreover, in case of pain, a specialized consultation by an algologist of La Sagesse will be realized."
15891203|NCT03717961|Drug|BOTOX® solution|Botox solution + Saline serum + lidocaine/prilocaine cream + Nitrous oxide/oxygen (50%/50%)
15891204|NCT03717961|Drug|Placebo group|Placebo + lidocaine/prilocaine cream + Nitrous oxide/oxygen (50%/50%)
15891209|NCT03717922|Device|Low Intensity Focused Ultrasound Pulsation|BOLD fMRI will be collected during two conditions (given that the timecourse of LIFUP related changes is unknown, sham will always precede the LIFUP condition). LIFUP (previously used in primary sensory cortices will be administered in 75 sonifications at 210 KHz frequency with pulse repetition frequency of 500Hz, 35mW/cm2, sonification duration 0.5s with 7s inter-stimulation intervals. Sham LIFUP will involve the same procedures (e.g. participant provided the same instructions) except the sonification will not occur.
15891210|NCT03717922|Device|SHAM Ultrasound|BOLD fMRI will be collected while the ultrasound trandsducer is not turned on. Participants are unable to tell whether the transducer is on or off.
15891211|NCT03717909|Drug|Sodium Valproate 200Mg E/C Tablet|Treatment with twice-daily oral tablet(s)
15891212|NCT03717909|Drug|Sodium Valproate matched placebo|Treatment with twice-daily oral 200mg tablet(s)
15891213|NCT03717896|Drug|200mg IV thiamine in 50mL 0.9% saline|Thiamine 200mg IV every 12 hours for 2 days
15891214|NCT03717896|Drug|Placebo|50mL 0.9% saline
15891215|NCT03717870|Procedure|Laparoscopic enucleation of ovarian endometrioma.|Laparoscopic enucleation of ovarian endometrioma (stripping of the peripheral capsule and coagulation using the lowest energy source available).
15891216|NCT03717870|Procedure|Prolonged pituitary downregulation|Treatment with GnRH-a (triptorelin, goserelin, and leuprolide), with add-back therapy (combined oral contraceptive) for 3-6 months.
15891217|NCT03717870|Procedure|Assisted Reproductive Technology (ART)|Fresh ART cycle: ovarian stimulation, oocyte retrieval, in vitro fertilization and embryo transfer.
15891218|NCT03717831|Other|Observational study of standard of care|Observational cohort study
15891219|NCT03717818|Behavioral|Good Psychiatric Management - Brief|specific interventions as defined by Gunderson and Links (2014)
15891220|NCT03717818|Behavioral|treatment as usual|non-specific intervention
15891221|NCT03717805|Other|POAM|The new 5 minutes preparatory information movie on oocyte aspiration (POAM) details what couples can expect to happen on the day of oocyte aspiration. More specifically, it describes the patient journey detailing which procedures will happen when and how, in which room, in the presence of their partner or not, and in the presence of which healthcare professionals.
15891222|NCT03717792|Other|no intervention|no intervention
15891223|NCT03717779|Diagnostic Test|lung ultrasound|we perform a lung ultrasound to all the patients admitted for dyspnea independantly from the final diagnosis
15891224|NCT03717766|Device|intraoperative neuronavigation ultrasound, intraoperative tractography, intraoperative fluorescence, advanced neuronavigation and intraoperative neurophysiology|"5-aminolevulinic acid (5-ALA) is a pro-drug that causes fluorescent protoporphyrins that accumulate in malignant gliomas. Fluorescence can be visualized during surgery by the use of a modified microscope, which helps the surgeon define the margins of the tumor.
~Neuro-navigated intraoperative ultrasound is an imaging technique that allows us to visualize intracranial lesions during surgery and correlate them with the image provided by the neuronavigator, obtaining a real-time view of the lesion and possible tumor remains.
~To achieve greater tumor resections without increasing the incidence of neurological deficits, the use of intraoperative neuromonitoring has been progressively implemented. This technology and specifically the brain mapping allows us to locate the functional areas of the brain and perform more aggressive resections with lower morbidity"
15891225|NCT03717753|Other|Pathway|The study team emphasizes that all components of the pathway are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the pathway will receive these standard of care components.
15891226|NCT03717740|Drug|Esomeprazole|Patients will take esomeprazole single dose of 40 mg orally once a day from 12+ and 17 weeks of pregnancy until 34 weeks of pregnancy
15891227|NCT03717740|Drug|Placebo|Patients will take an inert tablet similar in appearance, color, and consistency from 12+ and 17 weeks of pregnancy until 34 weeks of pregnancy
15891228|NCT03717727|Other|Exergame|16-week home-based exercise intervention with exergaming system and usual treatment.
15891229|NCT03717727|Other|Control|16-week home-based exercise by standard protocol and usual treatment.
15891230|NCT03717714|Dietary Supplement|Glucosamine 1500 mg|Patients in this group take 3 capsules, each capsule contains Placebo 16.7mg and Glucosamine 500 mg, once a day for 12 weeks
15891231|NCT03717714|Dietary Supplement|Polycan 50mg + Glucosamine 750 mg|Patients in this group take 3 capsules, each capsule contains Polycan 16.7mg and Glucosamine 250 mg, once a day for 12 weeks
15891232|NCT03717714|Dietary Supplement|Polycan 50mg + Glucosamine 1500 mg|Patients in this group take 3 capsules, each capsule contains Polycan 16.7mg and Glucosamine 500 mg, once a day for 12 weeks
15891233|NCT03717701|Drug|metformin|Patients will take metformin single dose of 1000 mg orally once a day
15891234|NCT03717701|Drug|esomeprazole|Patients will take esomeprazole single dose of 40 mg orally once a day
15891235|NCT03717701|Drug|Placebo|Patients will take inert tablets similar in appearance, color, and consistency
15891236|NCT03717688|Drug|Entresto|Single dose administration of Entrestro 194 mg sacubitril / 206 mg valstartan
15891237|NCT03717688|Drug|Sitagliptin 100mg|2 x 100mg sitagliptin as single dose.
15891238|NCT03717688|Drug|Placebos|No treatment
15891239|NCT03717675|Device|NovaCross™ Chronic Total Occlusion micro-catheter|The NovaCross™ micro catheter is a guidewire positioning and support micro catheter for improving chronic total occlusion (CTO) crossability. The NovaCross™ gains its supportive characteristics through the use of a unique operator-controlled Nitinol scaffold and an extendable segment. Investigators will use the NovaCross Micro catheter during a standard of care catheterization of patients diagnosed with coronary total occlusion.
15891240|NCT03717662|Drug|nicotine gum or nicotine patch|The project will provide intensive counseling at the Centre for Health Promotion (CHP) of HKU Department of Nursing Studies, female smokers who require more intensive counseling or advice on nicotine replacement therapy, upon referral from the women's organizations and trained women counselors. The smokers will receive face-to-face (or telephone) counseling and a 1 week supply of Nicotine replacement therapy (NRT) (4 mg nicotine gum or 10 mg/ 15 mg nicotine patch) from the nurse counselor, and follow up calls at 1 week, 1-, 3-, 6-, 36- and 72-month post-intervention.
15891241|NCT03717649|Device|Conventional 2-stage venous cannula|venous cannula
15891242|NCT03717649|Device|Conventional 3-stage venous cannula|venous cannula
15891243|NCT03717649|Device|Fenestrated 3-stage venous cannula|venous cannula
15891245|NCT03717623|Drug|Posaconazole pharmacokinetics|Blood samples will be collected on Days 7, 14 and 21 from the onset of Posaconazole prophylactic treatment If significant diarrhoea occurs, additional blood samples will be collected twice weekly until symptoms resolve. All blood samples will be used for Posaconazole pharmacokinetics study.
15891246|NCT03717610|Procedure|radical surgery with HIPEC|Straight after macroscopic radical cytoreductive surgery, an intraperitoneal hyperthermic perfusion using the open-abdomen technique will be performed with a single dose of cisplatin 100 mg/m2 administered for 90 minutes in the hyperthermic phase (41°C-43°C).
15891247|NCT03717597|Behavioral|Intervention|"Subjects will attend a series of 2 hour classes, once a week for 10 weeks. Topics discussed in group sessions will cover compensation strategies (e.g., calendar, goal setting and task lists, functional zones) and brain health behaviors (e.g., exercise, cognitive activity, stress reduction and mindfulness).
~Subjects may be asked to wear an actigraphy monitor (that looks like a wrist watch) and/or heart rate sensor that is designed to collect information regarding physical activity."
15891248|NCT03717571|Diagnostic Test|Glenohumeral translation assessment|amount of glenohumeral translation under load
15891249|NCT03717558|Drug|ivermectin T1|Subjects will be randomly assigned to one of the 20 different sequences of on single dose of ivermectin (T1, T2, and T3) and two single doses of Stromectol
15891250|NCT03717558|Drug|ivermectin T2|Subjects will be randomly assigned to one of the 20 different sequences of on single dose of ivermectin (T1, T2, and T3) and two single doses of Stromectol
15891251|NCT03717558|Drug|ivermectin T3|Subjects will be randomly assigned to one of the 20 different sequences of on single dose of ivermectin (T1, T2, and T3) and two single doses of Stromectol
15891252|NCT03717545|Other|second allogeneic stem cell transplantation|"Change another donor
~conditioning regimen: FLU/CY/anti-CD25 moAb"
15891253|NCT03717532|Procedure|Placebo|Patients will be receiving blood flow restriction therapy with a pressure cuff set to a placebo pressure setting.
15891254|NCT03717532|Procedure|Personalized Tourniquet System for Blood Flow Restriction|Patients will be receiving blood flow restriction therapy with a pressure cuff
15891255|NCT03717519|Diagnostic Test|Measurement of platelet count at diagnosis|Blood samples were drawn by expert phlebotomists in vacuum blood tubes containing K2-EDTA (Terumo Europe NV, Leuven, Belgium). The complete blood cell count (CBC) was performed using Advia 2120 (Siemens Healthcare Diagnostics, Tarrytown NY, USA). The local reference range for platelets was 150-400 x 109/L. The same analyser was used throughout the study period, and the quality and reproducibility of test results was validated by data of both internal quality control and external quality assessment
15891256|NCT03717506|Drug|GDC 268 Lotion|GDC 268 is a topical lotion
15891257|NCT03717506|Drug|Clindamycin Phosphate Lotion 1%|Clindamycin Phosphate Lotion is an FDA-approved drug product
15891258|NCT03717506|Drug|GDC Vehicle Lotion|GDC Vehicle Lotion contains 0.0% of active drug and is matched to the other two active test drugs
15891259|NCT03717493|Behavioral|Affect Regulation Training|Following the guidelines for the 6-week intensive ART format, we scheduled one 180-minutes session per week (each consisting of two modules à 90min) for a period of six subsequent weeks. Training groups included four to eight participants. The implementation of ART followed standardized treatment protocols (Berking & Whitley, 2014). ART was delivered by doctoral candidates (DCs) in clinical psychology who had completed or were in advanced stages of their clinical training. All therapists had been intensely trained and received weekly supervision from experienced ART trainers. To control adherence a random sample of 5% of all sessions was be videotaped and will be rated with regard to adherence.
15891260|NCT03717480|Device|ClinicMACs|The Reagent System will remove certain cells (called T-Cell Receptor (TCR) α/β positive T-cells) that are thought to cause GVHD from donor product before it is given to participants
15891261|NCT03717467|Drug|isotonic saline|100 ml of isotonic saline over 15 min immediately before induction of anesthesia and then 15 mg/kg/h by continuous I.V. infusion until the end of operation.
15891262|NCT03717467|Drug|Magnesium Sulfate|40 mg/kg of magnesium sulfate in 100 ml of isotonic saline over 15 min immediately before induction of anesthesia and then 15 mg/kg/h by continuous I.V. infusion until the end of operation.
15891263|NCT03717454|Other|Surgery|The medication will be stopped if failure to decrease prolactinoma size and the subjects will be advised to endoscopic transphenoidal pituitary surgery .
15891264|NCT03717454|Drug|Drug treatment|The medication will continue if DA causes tumors to shrink.
15891265|NCT03717441|Diagnostic Test|chromosome numeration of embryos|Use genomic technologies to analyze the discarded media drop for chromosome counting
15891266|NCT03717428|Device|Daily Weighing Group|The Experimental group will weigh themselves everyday
15891267|NCT03717428|Device|Control group|This group will be weighed and measured at the beginning and end of the study and will not be weighing themselves daily
15891268|NCT03717415|Drug|rebastinib|25 mg tablets or 75 mg tablets
15891269|NCT03717415|Drug|Carboplatin|Carboplatin administered by IV infusion at AUC5 or AUC6
15891270|NCT03717402|Other|STAMP App|STAMP--A patient-facing mobile phone app with a clinician web-based portal aimed to help advanced cancer patients and providers better co-manage cancer pain with opioids.
15891271|NCT03717402|Other|No access to STAMP App|Patients in this group will not have access to the STAMP app and will take part in a qualitative interview describing their experiences with chronic cancer pain management.
15891272|NCT03717389|Other|presence of soft tissue calcification in head and neck|soft tissue calcifications of the head and neck region in the Egyptian population
15891273|NCT03717376|Other|Self-questionnaire YSQ-S3 (Young Schema Questionnaire)|All participants will fill the YSQ-S3 at home and send it back to the main investigator.
15891274|NCT03717363|Procedure|Training programme|Training program in the primary care center supervised by a physiotherapist. The duration is two months and the frequency of sessions 3 times / week. Each session lasts 60 minutes.(30 minutes of aerobic exercise and 15 minutes of strength exercise).
15891275|NCT03717363|Behavioral|Educational talk|An educational talk given by the nurse and the physiotherapist about the components of a cardiosaluble lifestyle.
15891276|NCT03717350|Drug|Meropenem|2g of meropenem diluted in 100ml of sodium chloride 0.9% within 15 minutes intravenously administered once
15891277|NCT03717350|Drug|Placebo|100ml of sodium chloride 0.9% within 15 minutes intravenously once
15891315|NCT03717051|Drug|Nicotine replacement therapy (NRT) sampling|1-week free NRT samples (patch or gum)
15891278|NCT03717337|Procedure|Single visit pulp regeneration|Access cavity, disinfection, preparing and injecting platelet rich plasma, and restoring the tooth all done in one visit.
15891279|NCT03717337|Procedure|Two visit pulp regeneration|first visit : access, disinfection and placing calcium hydroxide as intracanal medicament second visit: re opening of tooth, preparing and injecting platelet rich plasma and restoring the tooth.
15891280|NCT03717324|Other|Procedure created in co-creation group|Interventions will be those obtained from the co-creation workshop with patients
15891281|NCT03717311|Other|Nutritional Intervention|The intervention will be done on 1 day, time during which, each subject will stay at the CRNH. A breakfast containing the fibers will be given to them, then during 24h a following will be done to get fecal, urinary, plasmatic and expiratory samples. Standardized lunch, dinner and collation will be served during the day.
15891283|NCT03717285|Procedure|Insert the UAS under direct vision|Patients in this group，we use rigid ureteroscopy to insert the UAS under direct vision.
15891284|NCT03717285|Procedure|Insert the UAS under non direct vision|Patients in this group，we insert the UAS by the experience of the surgeon and under non direct vision .
15891285|NCT03717272|Drug|AEF0117|AEF0117 capsules
15891286|NCT03717272|Drug|Placebo oral capsule|Corn oil capsule manufactured to mimic AEF0117 capsule
15891287|NCT03717259|Procedure|Open nephrectomy|The surgical technique for open nephrectomy consists of placing the donor in the lateral decubitus position and making an incision with or without rib resection that allows retroperitoneal access.
15891288|NCT03717259|Procedure|Hand-assisted laparoscopic nephrectomy|The hand-assisted technique begins with the incision for the introduction port of the hand, the renal artery and vein are divided using endoscopic staples and the graft is manually removed.
15891289|NCT03717259|Procedure|Laparoscopic nephrectomy|In the pure laparoscopic technique the patient is placed in the same position of lateral decubitus and after introducing the trocars in the abdomen, the colon is mobilized and the renal capsule is divided, the kidney is removed after performing the cut of the renal artery and vein through a suprapubic incision.
15891290|NCT03717246|Behavioral|Sleep Smart Latino|A culturally tailored group intervention aimed at improving sleep duration and quality for Latino middle school students.
15891291|NCT03717246|Behavioral|Basic Sleep Hygiene and Child Health|A group intervention providing sleep hygiene and child health topics education to Latino middle school students.
15891292|NCT03717233|Device|Exoskeleton|Ankle-foot exoskeleton - device to help reduce load on the bottom of the front of the foot
15891293|NCT03717220|Procedure|flap transferring|we use regional dorsal digital flaps for simultaneous reconstruction of multiple-digit soft-tissue defects
15891294|NCT03717207|Other|ecg Holter|all patients before to perform an head up tilt test for syncope evaluation will be steadied by ecg Holter to assess heart rate, heart rate variability.
15891295|NCT03717194|Drug|Ertugliflozin|Ertugliflozin as add-on to Metformin and/or DPP4 inhibitors in patients with inadequately controlled type 2 diabetes
15891296|NCT03717194|Drug|Placebo|Placebo as add-on to Metformin and/or DPP4 inhibitors in patients with inadequately controlled type 2 diabetes
15891297|NCT03717181|Drug|Lixivaptan|Daily dose of lixivaptan optimized using a predetermined titration protocol.
15891298|NCT03717168|Drug|Recombinant human growth hormone|All the patients received subcutaneous rHGH (0.3 IU/kg/ twice daily) for 10 days in addition to intensive care standard management.
15891299|NCT03717168|Other|Control|All patients will not receive growth hormone.
15891300|NCT03717155|Drug|Avelumab|Participants will receive avelumab intravenous infusions at a dose of 800 milligram (mg) on Day 1 and Day 8 of each 3-week cycle for the first 4 cycles. Thereafter, it will be given every 2 weeks in the Maintenance phase until disease progression or unacceptable toxicities.
15891301|NCT03717155|Drug|Cetuximab|Participants will receive cetuximab intravenous infusions at a dose of 250 milligram per meter square (mg/m^2) body surface area on Day 1 and 500 mg/m^2 body surface area on Day 8 of first 4 cycles of concurrent chemotherapy. Thereafter, it will be given at a dose of 500 mg/m^2 intravenous every 2 weeks in the Maintenance phase, until disease progression or unacceptable toxicities.
15891302|NCT03717155|Drug|Gemcitabine|Participants will receive gemcitabine intravenous infusions at a dose of 1250 mg/m^2 body surface area on Day 1 and Day 8 in 3-week cycles up to a maximum of 4 cycles.
15891303|NCT03717155|Drug|Cisplatin|Participants will receive cisplatin intravenous infusions at a dose of 75 mg/m^2 body surface area on Day 1 of 3-week cycles up to a maximum of 4 cycles.
15891304|NCT03717142|Combination Product|LUM Imaging System|Patients will be injected with one of 3 study doses of LUM015, or have no LUM015 intervention, and tissue will be imaged in vivo and ex vivo with the LUM imaging device.
15891305|NCT03717129|Drug|Genvoya Oral dose|Single Genvoya oral dose directly observed
15891306|NCT03717129|Drug|Genvoya Crushed Dose|Single Genvoya crushed tablet in water directly observed
15891307|NCT03717116|Diagnostic Test|parathormone level|From the patients, blood will be taken preoperatively and postoperatively.
15891308|NCT03717103|Drug|IBI188|"0.1 mg/kg IV QW 0.3 mg/kg IV QW
~1 mg/kg IV QW"
15891309|NCT03717103|Drug|IBI188|3 mg/kg IV QW 10 mg/kg IV QW 20 mg/kg IV QW 30 mg/kg IV QW
15891310|NCT03717103|Drug|IBI188, Rituximab|Recommended dose from Ia
15891311|NCT03717090|Other|No intervention|Sample collection study Sample collection and collection of laboratory values
15891312|NCT03717077|Procedure|learned resourcefulness intervention|The LR program includes: 1) Solving problem strategy, 2) Organizing daily actions, 3) Using self-regulation, 4) Reframing positive situations, 5) Changing negative self-thinking, 6) Exploring new thinking and skills. It is conducted one time per week.
15891313|NCT03717064|Drug|RO7049389|RO7049389 will be taken orally, in tablet form, BID on Days 1-6 of Period 2.
15891314|NCT03717064|Drug|Pitavastatin|Pitavastatin will be taken orally, in tablet form, once on Day 1 of Period 1, and once on Day 4 of Period 2.
15891316|NCT03717051|Behavioral|Medication counseling|Medication counseling
15891317|NCT03717038|Drug|Sym004|Sym004 is a 1:1 mixture of two recombinant mAbs (futuximab and modotuximab) which bind specifically to non-overlapping epitopes located in the extracellular domain (ECD) of the EGFR.
15891318|NCT03717038|Drug|TAS-102|TAS-102 is a combination of trifluridine, a thymidine-based nucleic acid analogue, and tipiracil, a thymidine phosphorylase inhibitor.
15891319|NCT03717025|Procedure|SUCTION BLISTER EPIDERMAL GRAFTING|"Preferred donor sites for making blister is lateral aspect of upper thigh. The area is shaved and cleansed with surgical spirit.
~Blister formation is induced by using suction apparatus.
~Recipient site is surgically prepared by doing dermabrasion.
~After formation of blisters, each blister is gently cleansed with normal saline and cut all along its border with curved iris scissors parallel to the skin surface. The roof is everted over the thumb with dermal surface facing upwards and then with the help of blunt end of forceps it is placed on the recipient area.
~The graft is firmly pressed with sterile moist gauze to remove any underneath serous collection.
~The pressure dressing is done with double layer framycetin tulle, moist gauze and bandage.
~Donor area is dressed with dry sterile pads.
~The part is immobilized and Antibiotics and Analgesic are given till dressing are removed (after 5-7 days)."
15891320|NCT03717025|Procedure|MINI PUNCH GRAFTING|"Recipient area is prepared first after shaving and cleaning with surgical spirit. 2 % lignocaine with or without adrenalin will be infiltrated as local aneasthetic.
~The punched out chambers are spaced at a gap of less than 5 mm (preferably 2 - 2.5 mm) from each other.
~The donor area is either upper lateral portion of thigh or gluteal region.
~Grafts are placed directly from donor to the recipient area. Care is taken, so that graft edges are not folded, the tissue is not crushed or placed upside down.
~Hemostasis is achieved by pressing a saline soaked gauze piece over the area.
~For the recipient area 3 layers of dressing from inside out are : paraffin embedded non adherent sterile gauze, sterile surgipad, and micropore.
~For the donor area only surgipad and micropore are used.
~Immobilisation of recipient area is advised along with antibiotics and analgesics till removal of dressing (after 4-7 days)."
15891321|NCT03717025|Procedure|NON CULTURED EPIDERMAL CELL SUSPENSION|"About one-tenth the size of recipient area is selected as the donor site.
~Split thickness skin graft is taken under aseptic precautions with the help of a shaving blade held firmly by a straight artery forceps.
~The area is dressed with Bactigras gauze.
~Split thickness skin specimen is transferred under aseptic conditions to a container with Normal Saline and transferred to laboratory for preparing suspension.
~Recipient site is dermabraded under aseptic precautions until tiny pinpoint bleeding spots are seen.
~Epidermal cell suspension is carefully transferred to a tuberculin syringe.
~With 18 gauge needle attached to this syringe, suspension is spread evenly on dermabraded recipient site.
~This is then covered with Collagen dressing, followed by bactigras, guaze and tegaderm dressings from inside to outside.
~The patient is observed for 2 hours after performing the procedure and given antibiotics and analgesics for 5-7 days till dressing removal."
15891322|NCT03717012|Drug|Nintedanib|stable dose
15891323|NCT03717012|Other|Pulmonary rehabilitation program|12 weeks
15891324|NCT03716999|Other|Starlight Therapy|Starlight Projector will be placed in patients' rooms and project starlight on the ceilings and walls in an effort to reduce unpleasant symptoms
15891325|NCT03716986|Diagnostic Test|MRI Oxygen Saturation Map|Calculation of the oxygen saturation map of gliomas cases
15891326|NCT03716973|Device|High Density Programming|Patients implanted with Medtronic spinal cord stimulator will have high density programming.
15891327|NCT03716960|Other|Pumpkin Seed Oil|This intervention consisted of 6 weeks of PSO consumption. Subject were supplemented with 3 g/day of PSO which was ingested in the form of 1g capsules with each main meal of the day (breakfast, lunch and dinner).
15891328|NCT03716960|Other|Placebo|This intervention consisted of 6 weeks of placebo consumption. Subject consumed 1 capsule of maltodextrin with each main meal of the day to match the dose and number of capsules ingested daily by the PSO group.
15891329|NCT03716947|Procedure|Device: ZACK|Surgical procedure with total disc replacement using ZACK disc prostheses
15891330|NCT03716947|Procedure|Device: ORBIT|Surgical procedure with total disc replacement using ORBIT disc prostheses
15891331|NCT03716947|Procedure|Device: SASCA|Surgical procedure with anterior intracorporal fusion (ALIF) combined with adjacent level total disc replacement (TDR) (using either ORBIT mechanical disc prosthesis or ZACK viscoelastic disc prosthesis)
15891332|NCT03716934|Device|Arctic Front Advance® balloon catheter|Cryoablation of bidirectional block of all pulmonary veins
15891333|NCT03716934|Drug|Antiarrhythmic drug|The drug will be chosen based on the preference of the researcher / responsible physician and current clinical practice guidelines.
15891334|NCT03716934|Device|Confirm RX heart monitor® (Abbott)|Is a subcutaneous implantable device that provides continuous monitoring of the heart rate for more than 3 years without any effect on cardiac function
15891335|NCT03716921|Other|Short antibiotics treatment|Patients randomized in this arm will pursue antibiotic administration until visit 3 weeks after D0
15891336|NCT03716882|Device|Song Meter (SM)4|Their cries will be longitudinally registered using an automatic record device: Song Meter (SM)4 during 3 consecutive days and nights. This record will take place at 15 days of life, 1 and half months, 2 and half months and 3 and half months.
15891337|NCT03716869|Other|Universal Screening Arm|"Students with PHQ-9 score >10, corresponding to a positive MDD screen, will proceed through the same SAP triage process as students referred by traditional means.
~SAP triage will determine MDD identification. As SAP triage is not diagnostic, MDD identification is based on SAP recommendations for MDD related school or community services.
~Treatment engagement will be tracked per current SAP processes.
~To immediately identify and address suicidal intent, the survey will flag a positive response to PHQ-9 question 9 in real time. A suicidal student would proceed directly to management through the school crisis plan.
~Students in the intervention arm will also be tracked for behavior concerning for MDD at any point in the school year prompting SAP triage referral."
15891338|NCT03716856|Genetic|CAR-BCMA T cells|"Single dose of CAR-BCMA T cells will be infused, and classic 3+3 dose escalation will be applied."
15891339|NCT03716856|Drug|Fludarabine|Fludarabine is used for lymphodepletion.
15891340|NCT03716856|Drug|Cyclophosphamide|Cyclophosphamide is used for lymphodepletion
15891372|NCT03716609|Other|Food grade citrate acid|Food grade citrate acid 0.1 gram from San Fu Chemical Co., Ltd (Taipei, Taiwan)
15891373|NCT03716609|Other|Splenda(Sucralose)|Splenda 1.0 gram from Splenda(Carmel, Indiana, USA)
15891374|NCT03716596|Radiation|SBRT|SBRT radiation dose is 40-50 Gy in total.
15891341|NCT03716843|Other|Pressure monitoring system|"The pressure measurement undergarment will be given to all consenting AIS patients who have received their own thoraco-lumbo-sacral orthosis (TLSO) rigid brace. Each patient will wear the undergarment first and the TLSO brace on top. FBG sensors embedded in the undergarment will measure each pressure signal at approximately 2 minutes. The average force reading will be calculated.
~Then, the experiment will be repeated once, but the anisotropic textile brace will replace the TLSO brace. The pressure measurement system will be used to obtain an accurate and adequate comparison of the forces applied to the patients. The effectiveness of the anisotropic textile brace will be evaluated through X-ray radiography, and its correction effect with be compared with that of the TLSO brace."
15891342|NCT03716830|Device|verum acupuncture|Participants will receive real acupuncture treatment.
15891343|NCT03716830|Device|sham acupuncture|Participants will receive sham acupuncture treatment.
15891344|NCT03716830|Device|real tDCS|Participants will receive real transcranial direct current stimulation.
15891345|NCT03716830|Device|sham tDCS|Participants will receive sham transcranial direct current stimulation.
15891346|NCT03716817|Device|Tetric CAD|Resilient ceramic crowns (Tetric CAD by Ivoclar Vivadent) are placed using an adhesive bonding process including a total etch process with a universal adhesive (Adhese by Ivoclar Vivadent) and dual cured resin cement (Variolink Esthetic by Ivoclar Vivadent).
15891347|NCT03716804|Drug|Tablet Nitrofurantoin|Tablet Nitrofurantoin (100 mg), two times daily in 12 hours interval for 7 days
15891348|NCT03716804|Drug|Tablet Ciprofloxacin/ Tablet Cefixime/ Tablet Cefuroxime|Tablet Ciprofloxacin (500 mg), two times daily in 12 hours interval for 7 days or, Tablet Cefixime (200 mg), two times daily in 12 hours interval for 7 days or, Tablet Cefuroxime (250 mg), two times daily in 12 hours interval for 7 days
15891349|NCT03716791|Dietary Supplement|methylsulfonylmethane|3g per day
15891350|NCT03716791|Dietary Supplement|placebo|white rice flour
15891351|NCT03716778|Other|Eccentric rehabilitation sessions|"ECC cycling will be conducted using a commercially available ECC motor-driven ergometer. Intensity and duration are progressively increased during the first five sessions in order to minimize the extent of exercise-induced muscle soreness.
~The subjects will perform five sessions of endurance training on cycle ergometer per week. Each session lasting 30 minutes will be achieved at an intensity corresponding to the pre-determined CON ventilatory threshold. In the ECC group, 3 sessions of ECC (Monday, Wednesday and Friday) and two session of concentric (Tuesday and Thursday) cycling will be carried out each week. In the control group CON all sessions will be achieved using the traditional pedaling mode."
15891352|NCT03716765|Dietary Supplement|locally injected vitamin D|locally injected vitamin d as non surgical method for periodontal regeneration of vertical bony defects
15891353|NCT03716752|Procedure|Modified connective tissue graft wall with wing technique|the usage of bone graft and collagen barrier to treat recession defects accompanied vertical bony defcets in posterior teeth
15891354|NCT03716739|Drug|Testosterone Cypionate 100 MG/ML|100 mg testosterone cypionate administered by intramuscular injection weekly for 12 weeks.
15891355|NCT03716739|Drug|Placebo|Placebo administered by intramuscular injection weekly for 12 weeks.
15891356|NCT03716726|Behavioral|WE CARE SDoH Screening Survey|The survey will be given at all visits by the front desk staff to all parents of SCA patients. It consists of 12 questions designed to: (1) briefly identify 6 unmet material needs (e.g., childcare, employment, food security, household heat, housing inadequate education) by self-report and (2) using a family-centered approach, determine whether parents would like assistance with each problem Parents wanting help will receive a resource referral. Clinical team members will be trained to review the WE CARE SDoH survey at visits and to provide community resource information sheets to parents with needs. Completed surveys will be scanned into the EHR
15891357|NCT03716726|Behavioral|Family Resource Book|The Family Resource book will contain one-page information sheets listing community resources (e.g., food pantries) and their contact information (i.e. telephone number) for each specific material need (e.g., food insecurity). Information sheets will be specific to each site and written at, or below, the 8th grade level. For parents with an identified need, providers will be instructed to give an information sheet. The book will contain six separate tabs, one for each unmet need, and will contain multiple copies of the information sheets. The Family Resource Book will be made available in each exam room. The investigators will work with each practice to create a Family Resource Book prior to study initiation.
15891358|NCT03716726|Other|Standard of care|Usual outpatient care for pediatric patients with sickle cell anemia will be provided.
15891359|NCT03716713|Device|CeraShield Endotracheal Tube|Subjects requiring mechanical ventilation with be intubated with the CeraShield ETT
15891360|NCT03716700|Biological|CUVITRU|CUVITRU
15891361|NCT03716687|Device|Prophylactic negative pressure wound dressing after laparotomy|Five days of -90 Hgmm continuous negative pressure wound dressing left on primary closed laparotomy wound.
15891362|NCT03716674|Device|Metronome|Patients completed 4 walking sessions of at least 10 minutes each. During each session, no auditory rhythm was given, or the rhythm of a Rhythmic Auditory Stimulation (RAS) adapted to the pace of comfort of each patient using a metronome was broadcasted via headphones. In all, 4 conditions were tested: walk with no RAS or an isochronous RAS or a random RAS or a RAS with an autocorrelated metronome rhythm.
15891363|NCT03716661|Procedure|ORIF|Open Reduction Internal Fixation
15891364|NCT03716648|Diagnostic Test|DISE-assisted titration|Titration of the mandibular position with the remotely controlled mandibular positioner during drug-induced sleep endoscopy.
15891365|NCT03716648|Diagnostic Test|PSG-guided titration|Titration of the mandibular position with the remotely controlled mandibular positioner during drug-induced sleep endoscopy.
15891366|NCT03716648|Device|subjective titration|Titration of the mandibular position based on subjective improvement in symptoms like snoring and excessive daytime sleepiness.
15891367|NCT03716635|Procedure|cryotherapy|2.5c cold saline is used as a final flush after chemomechanical preparation
15891368|NCT03716635|Procedure|normal saline|a room temperature saline is used as a final flush after mechanical preparation
15891369|NCT03716622|Drug|Furazolidone|bismuth-furazolidone-containing quadruple regimens
15891370|NCT03716622|Drug|Clarithromycin|bismuth-clarithromycin-containing quadruple regimens
15891371|NCT03716609|Dietary Supplement|Magnesium Citrate|Pure Magnesium citrate powder 2.07 gram from NOW FOODS (Bloomingdale, IL, USA)
15904429|NCT03615105|Drug|Fludarabine|Fludarabine 25 mg/m2 IV
15891375|NCT03716596|Drug|anti-PD-1 antibody|Intravenous drug of anti-PD-1 antibody, 200mg, once a time, every three weeks.
15891376|NCT03716583|Drug|Melatonin|25 mg
15891377|NCT03716583|Drug|Dimethyl Sulfoxide|150 mg
15891378|NCT03716583|Drug|Placebos|1 g
15891379|NCT03716570|Drug|BIIB054|Administered as specified in the treatment arm.
15891380|NCT03716570|Drug|Placebo|Administered as specified in the treatment arm.
15891381|NCT03716557|Device|Spinal Cord Stimulation 4000Hz|Differential programming of the Boston Scientific Precision™ Plus Spinal Cord Stimulator System
15891382|NCT03716557|Device|Spinal Cord Stimulation 10000Hz|Differential programming of the Boston Scientific Precision™ Plus Spinal Cord Stimulator System
15891383|NCT03716557|Device|Spinal Cord Stimulation 40Hz|Differential programming of the Boston Scientific Precision™ Plus Spinal Cord Stimulator System
15891384|NCT03716544|Device|Amplification with hearing aid|Use of hearing aids
15891385|NCT03716544|Device|Customized music|Customized music delivered via an iPod
15891386|NCT03716531|Radiation|IORT|IORT works by delivering radiation therapy to the tumor while reducing the amount of healthy tissue exposed to the radiation therapy
15891387|NCT03716518|Drug|Tonifying Spleen and Kidney Sequential Regimen|TSKSR will be given to the participants as follows:Liu-jun-an-wei Granule,1 pack each time,twice a day,PO,from 0 to 6th day of chemotherapy and Qi-tu-er-zhi Granule,1 pack each time,twice a day,PO,from 7th to 20th day of chemotherapy.
15891388|NCT03716518|Drug|Placebo of 'Tonifying Spleen and Kidney Sequential Regimen|Placebo of TCM-TSKSR will be given to the participants as follows:placebo of Liu-jun-an-wei Granule,1 pack each time,twice a day,PO,from 0 to 6th day of chemotherapy and placebo of Qi-tu-er-zhi Granule,1 pack each time,twice a day,from 7th to 20th day of chemotherapy.
15891389|NCT03716505|Device|gammaCore Sapphire active|GammaCore Sapphire™ is a handheld, non-invasive, low voltage electrical device which stimulates the vagus nerve by producing weak 120 second electrical stimulation cycles that may help reduce, ease, lessen or stop your migraine symptoms. GammaCore Sapphire™ has been approved for the treatment of headache, including migraine by the United States Food and Drug Administration (FDA).
15891390|NCT03716505|Device|gammaCore Sapphire Sham|The sham device is a hand-held portable device that appears identical to gammaCore Sapphire, in look, weight, visual and audible feedback, user application, and control. Like gammaCore Sapphire, the sham device is a multi-use device.
15891391|NCT03716479|Other|Low Fiber|20 g of acacia gum will be added to orange juice
15891392|NCT03716479|Other|High Fiber|40 g of acacia gum will be added to orange juice
15891393|NCT03716479|Other|Placebo/Control|No acacia gum will be added to orange juice.
15891394|NCT03716466|Other|Endotracheal intubation|Subjects will receive prophylactic endotracheal intubation for upper gastrointestinal endoscopy procedure
15891395|NCT03716466|Other|No airway intervention|Subjects without prophylactic endotracheal intubation during upper gastrointestinal endoscopy procedure
15891396|NCT03716453|Procedure|Standard protocol|Give narcotic according to vital signs
15891397|NCT03716453|Procedure|ANI protocol|"ANI score 50-70 indicates optimal narcotic effect. ANI score > 70 indicated overdosage of narcotic and narcotic should be withheld.
~ANI score < 50 indicates inadequate narcotic and narcotic should be given."
15891398|NCT03716440|Other|Nature exposure|Participants will view images of nature.
15891399|NCT03716440|Other|Non-nature exposure|Participants will view non-nature images.
15891400|NCT03716427|Drug|CT1812|
15891401|NCT03716427|Drug|tolbutamide|Single-sequence drug-drug interaction study to determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of tolbutamide
15891402|NCT03716427|Drug|dextromethorphan|Single-sequence drug-drug interaction study to determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of dextromethorphan
15891403|NCT03716427|Drug|Omeprazole|Single-sequence drug-drug interaction study to determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of omeprazole
15891404|NCT03716427|Drug|midazolam|Single-sequence drug-drug interaction study to determine the effect of CT1812 (560 mg) once daily on the pharmacokinetics of midazolam
15891405|NCT03716414|Procedure|SLN mapping|"Intra-operative SLN mapping with indocyanine green: Intracervical injection will be performed by the surgeon. Sub-mucous injections will be performed with 50% diluted dye at 3 and 9 o'clock positions. 1ml injection contained infracyanine green will be injected deeply into the stroma of the cervix (1cm-depth), and Arms Assigned Interventions another 1ml will be injected superficially (2mm-depth).
~The time between the injection and the search for SLN must be as soon as possible."
15891406|NCT03716401|Diagnostic Test|MRI (magnetic resonance imaging)|An MRI (or magnetic resonance imaging) scan is a radiology technique that uses magnetism, radio waves, and a computer to produce images of body structures. The MRI scanner is a tube surrounded by a circular magnet.
15891407|NCT03716401|Diagnostic Test|US (ultrasound)|An ultrasound scan is a medical test that uses high-frequency sound waves to capture live images from the inside of the body.
15891408|NCT03716401|Procedure|Renal Biopsy|A kidney biopsy involves taking one or more tiny pieces (samples) of the kidney to look at with special microscopes. The microscopes make it possible to see the samples in greater detail.
15891409|NCT03716401|Diagnostic Test|Positron Emission Tomography (PET)|Positron emission tomography (PET) uses small amounts of radioactive materials called radiotracers, a special camera and a computer to help evaluate organ and tissue functions. By identifying body changes at the cellular level, PET may detect the early onset of disease before it is evident on other imaging tests.
15891410|NCT03716401|Diagnostic Test|Microvascular Assessment|Glycocalyx (a network of membrane proteoglycans and glycoproteins lining all blood vessels) thickness is non-invasively estimated from video clips of sublingual vessels captured using a hand held microscope. Glycocalyx is vital for vascular health; perturbations in the glycocalyx are thought to contribute to numerous vascular health complications including DKD.
15891411|NCT03716388|Biological|Fecal Microbiota Transplantation|Freshly passed stools (80 g) will be diluted with normal saline (200 ml) and homogenized using a blender, filtered, filled into 4 syringes (50 ml each) and used within 1 hour of preparation or 6 hours of passage of stools. Polyethylene glycol lavage will be done for bowel preparation and the slurry administered into the ileum and/or caecum by colonoscopy. Post FMT, recipients will be encouraged to retain the slurry for 4-6 hours. FMT sessions will be scheduled at weeks 0,2,6,10,14.
15904430|NCT03615105|Drug|Melphalan|Melphalan 70 mg/m2 IV
15891412|NCT03716388|Drug|Mesalamine Granules|Mesalamine granules 4 grams a day
15891413|NCT03716388|Other|Placebo infusion|Water with food grade colour to resemble fecal slurry
15891414|NCT03716388|Other|Placebo granules|Granules resembling mesalamine granules, 4 grams a day
15891415|NCT03716375|Drug|Intrapleural Medications|urokinase
15891416|NCT03716362|Device|Otoacoustic emissions device|as a screening tool for Auditory brainstem response
15891417|NCT03716349|Diagnostic Test|Pulp vitality testing|each tooth will be tested to determine if the pulp of the tooth responds to cold
15891418|NCT03716349|Other|Photos|Photos of teeth (Photos will be taken with a DSLR camera settings will be determined with optimal settings) and captured periodically throughout the study. Photographs will be made of the cavity preparation. Photographs will be made post-operatively
15891419|NCT03716349|Drug|local and/or topical anesthetic|Local and/or topical anesthetic will be applied as necessary to the teeth or gingiva
15891420|NCT03716349|Device|rubber dam|The area will be isolated with rubber dam isolation
15891421|NCT03716349|Other|tooth surface cleaned|The tooth surface will be cleaned with flour of pumice on a prophy cup only, cavity preparation will be performed as usual for caries removal.
15891422|NCT03716349|Procedure|enamel margins|Enamel margins will be beveled with a long flame diamond bur (8863.314.012 Komet) at 45 degrees to the external tooth surface to achieve the desired bevel length. Along with the use of the diamond bur, infinite invisible margins will be created by contouring and smoothing with a dark orange Sof-LexTM extra-thin contouring and polishing disc (3M).
15891423|NCT03716349|Procedure|Adhesive Systems|Adhesive systems will be applied according to manufacturer's instructions and selective etching of the enamel will be performed. The dental composite will be incrementally placed using a two- layer or one-layer technique based on the cavity size and light-cured (detailed adhesive instruction sheet will be chairside for reference)
15891424|NCT03716349|Procedure|cavity preparation|The technique to be used will be determined by the size of the final cavity preparation. For small preparations a one-layer technique will be used. No backing material is necessary for the Tokuyama system, Filtek Supreme Ultra will be determined by manufacturer's wheel. A two-layer technique will be used for a large cavity preparation. Large cavity preparation is defined as being 4mm in length or more and/or at least 2mm in depth.
15891425|NCT03716349|Other|Shade selection using Easy Shade 5|A1 (shade determined by Easy Shade 5), ECM-001/Backing material, A1E/A2D (shade will be selected by shade wheel) A4 (shade determined by Easy shade5), ECM-001/Backing material, A3E/A6D (shade will be selected by shade wheel
15891426|NCT03716349|Procedure|Light Curing|A Valo Grand curing unit (Ultradent) with an exitant irradiance with no less than 500 and no greater than 1500 mW/cm2 as measured with MARC Light Collector will be used in standard mode to deliver the required radiant exposure J/cm2 for adhesive and dental composite increments.
15891427|NCT03716349|Procedure|Contoured and polished|The restoration will be contoured and polished with - Long flame diamond bur (8863.314.012 Komet), Sof-Lex Medium (orange) Contouring and Polishing Discs (3M), Green Jiffy cup pre-polisher (Ultradent Products, Inc.), Blue and grey silicone points composite polisher gloss plus finisher (Kerr Hawe)
15891428|NCT03716349|Other|Consent|The consent form will be signed, copy will be provided to the patient
15891429|NCT03716349|Other|Health Questionnaire|The health questionnaire will be completed at initial visit and updated at each follow-up visit
15891430|NCT03716349|Radiation|xray|When necessary a radiograph (xray) will be obtained
15891431|NCT03716349|Other|Release of medical information signed|The release of medical information form will be signed
15891432|NCT03716349|Other|Oral Exam|An Oral Exam will be completed
15891433|NCT03716349|Other|Teeth Assessment|The teeth assessment by subject will be completed using the Visual Analog Scale (VAS) and Verbal Rating Scale (VRS) at the follow-up visits 1 month after restoration, 1 year, 2 years and 3 years post restoration.
15891434|NCT03716349|Other|Clinical Assessment|A clinical assessment will be completed by the evaluators
15891435|NCT03716349|Device|Tokuyama Universal Bond|Tokuyama Universal Bond (TUB) single component self-etching 1-step adhesive system with Tokyuama supra-nanofilled dental composite (ECM) (Tokuyama Dental Corp., Japan)
15891436|NCT03716349|Device|ScotchBond|Scotch Bond Universal one-step adhesive system with Filtek Supreme Ultra™, nanofilled dental composite (3M)
15891437|NCT03716336|Other|Resistance exercise|Resistance exercise were performed for all participants in group (A) only included 9 exercise for big muscles of upper limbs (shoulder flexors muscles, shoulder extensors and shoulder abductors), lower limbs (hip flexors, hip extensors and knee flexors and knee extensors) and abdominal muscle using moderate work load (60 - 75% of IRM) 1set of 10 repetitions, progressing to 2 sets of 10 repetitions after four weeks for 20 minutes
15891438|NCT03716336|Other|Aerobic exercise|aerobic exercise were performed on treadmill. For 20 minutes. All patients in both groups (A,B) had attended the program of a resistance exercises and followed by aerobic exercise for 8 weeks in form of 20 minutes walking on the treadmill without inclination.
15891439|NCT03716336|Dietary Supplement|diet restriction|All participants in both groups (A,B) were instructed to follow a moderate restricted diet limited to (1800-2000) kcal/ day under supervision of a certified dietician. The diet contained: Protein and fibers: 20% carbohydrate: 50-60%, fat: low 20%.
15891440|NCT03716323|Device|immediate premolar implant with xenograft and allograft|"A peritome will be used for atraumatic extraction of remaining roots.
~The extraction socket will be evaluated for absence of any fenestration or granulation tissues.
~Copious normal saline irrigation and curettage will be performed.
~In the study group: Immediate implant insertion following standard manufacturer's recommended surgical protocol followed by grafting the jumping gap with cortico-cancellous allograft (MinerOss®, BioHorizons, USA)
~In the control group: Immediate implant insertion following standard manufacturer's recommended surgical protocol followed by grafting the jumping gap with anorganic bovine bone mineral xenograft (Bio-Oss®, Geistlich, USA)"
15891473|NCT03716037|Other|Physical Activity for Life (PAL)|The eight-week exercise program (The PAL Study) will incorporate balance, strength, endurance, and flexibility training. The duration of each exercise session, which will be offered three times a week, will be one hour. The supervised exercise session will include 30 minutes of moderate-intensity aerobic exercise, 15 minutes of resistance training, and 15 minutes of stretching and balance training
15891474|NCT03716024|Drug|PTK 0796|PTK 0796 100 mg for injection; PTK 0796 capsule 100 mg
15891475|NCT03716024|Drug|Linezolid|Pre-mixed 600 mg IV infusion solution; Linezolid 600 mg tablets
15891441|NCT03716310|Diagnostic Test|platelet responsiveness evaluation|Blood samples were anticoagulated with 0.129 mmol/L of sodium citrate and then centrifugated for 10 min at 200 rpm; platelets aggregation was assessed with an AggRAM Advanced Modular System light transmittance aggregometer (Helena Laboratories, Beaumont, Texas, USA). Low-molecular-weight heparin (LMWH) was given at least 8 hours before any blood aggregation sample. Agonist used to initiate aggregation test were: -Adenosine diphosphate (ADP) to assess P2Y12-dependent platelet aggregation; (20 ng) - Arachidonic acid (AA) to assess cyclooxygenase-dependent platelet Adenosine diphosphate aggregation (1 mcg) - thrombin receptor-activating peptide-6 (TRAP-6) to assess protease-activated receptor 1-dependent platelet aggregation. Max aggregation reached (Aggmax), the slope of the curve (slope) and the latency time (lat) were analyzed for each agonist.
15891442|NCT03716284|Procedure|Electromagnetic navigation bronchoscopy (ENB)|ENB is carried out by a ENB system（LungCare, China) with/without other guided bronchoscopy techniques and/or ROSE, which can offer real-time navigation for bronchoscopy reaching peripheral pulmonary nodules.
15891443|NCT03716271|Device|Visual Acuity Examination with a novel lens|Visual Acuity Examination with a novel lens set in an ophthalmic trial frame
15891444|NCT03716245|Procedure|supraclavicular lymph node dissection|people with supraclavicular lymph node metastasis before surgery should receive dissection of supraclavicular lymph node and the supraclavicular lymph node metastasis should be confirmed either by core needle biopsy or fine needle aspiration biopsy
15891445|NCT03716245|Radiation|supraclavicular area radiotherapy|people with supraclavicular lymph node metastasis before surgery should receive radiotherapy of supraclavicular area and the supraclavicular lymph node metastasis should be confirmed either by core needle biopsy or fine needle aspiration biopsy
15891446|NCT03716232|Device|Metallic stent|"All procedures will be performed under propofol sedation. Strictures will be identified by cholangiography and then dilated by a dilating balloon (diameter 6-10mm). A 4-6cm fully covered expandable metallic stent (Kaffes stent, Taewoong medical, Seoul, Korea) will then be deployed at the level of the stricture. In cases close to the hepatic hilum where the deployment of the stent is expected to reach one duct and possibly block another duct, a 7 Fr stent will be inserted prior to deployment of the metallic stent in the contralateral duct..
~- Stent will be extracted endoscopically after 6 months."
15891447|NCT03716232|Device|Multiple plastic stents|"Strictures will be identified by cholangiography and then dilated by a dilating balloon (diameter 6-10mm). A 10 French plastic stent will be inserted bypassing the level of the stricture.
~Stent replacement and the addition of further stents will be planned after 3 months from the initial procedure and every 3 months until stricture resolution occurs with a maximum of four procedures. Balloon dilatation with a 6-10 mm balloon will be used in each session before stent insertion."
15891448|NCT03716219|Other|Exercise Training|Physical activity in children and adults with asthma.
15891449|NCT03716206|Device|Exergame|This intervention included upper limb task-orientation training, upper limb coordination training, shoulder range of motion and upper limb activity training.
15891450|NCT03716206|Other|Physical therapy|This intervention included upper limb task-orientation training, upper limb coordination training, shoulder range of motion and upper limb activity training.
15891451|NCT03716193|Other|Oxygen|Patients will be given oxygen via a facemask during the measurement session
15891452|NCT03716180|Drug|Paclitaxel|"Paclitaxel is an anti-cancer (antineoplastic or cytotoxic) chemotherapy drug"
15891453|NCT03716180|Drug|Trastuzumab|Trastuzumab works by targeting the HER2/neu receptor on cancer cells
15891454|NCT03716180|Drug|Pertuzumab|Pertuzumab is a monoclonal antibody which targets the surface of the cells human epidermal growth factor receptor 2 protein (HER2) on the cancer cell, interfering with HER2 causing cancer cell death
15891455|NCT03716167|Device|Summus Laser|infrared laser treatment
15891456|NCT03716167|Device|Summus Laser Sham|non-infrared light
15891457|NCT03716154|Radiation|Diode laser|Diode laser 810nm, 2W, 20sec, 20 HZ
15891458|NCT03716141|Other|Autologous Platelets Rich Plasma Treatment|For PRP preparation 10 mL of the patient blood was collected. The blood was centrifuged at 2000 rpm for 5 min to obtain plasma. Then, this plasma was centrifuged at 3000 rpm for another 5 min to collect platelets. Platelets were diluted in 5 mL plasma to form PRP.
15891459|NCT03716141|Other|Conventional Saline dressing|saline dressing of diabetic wounds will be done
15891460|NCT03716128|Diagnostic Test|18F-PET|Bone biopsy and 18F-PET
15891461|NCT03716115|Dietary Supplement|Colostrum high protein powder (Neovite)|Bovine colostrum provided as powder will be reconstituted and administered orally or via NG tube.
15891462|NCT03716115|Drug|N-Acetyl Glucosamine (GInNAC)|N-Acetyl glucosamine provided as powder will be reconstituted and administered orally or via NG tube.
15891463|NCT03716115|Drug|Teduglutide|Teduglutide will be administered daily as subcutaneous injection
15891464|NCT03716115|Drug|Budesonide|Budesonide liquid (as marketed for nebulisation) will be administered orally or bia NG tube daily.
15891465|NCT03716102|Device|PCI with implantation with DES|PCI with implantation with DES
15891466|NCT03716089|Procedure|Laparoscopic resection|Laparoscopic surgery under general anesthesia
15891467|NCT03716076|Drug|Carbetocin|50 mcg or 100 mcg bolus of carbetocin
15891468|NCT03716063|Drug|Jianpi Huatan dispensing granule|once a day in the morning and evening, every month for a course of treatment, a total of three courses
15891469|NCT03716050|Drug|Nitroglycerin|Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 2,4,6, and 8 will include Nitroglycerin cream.
15891470|NCT03716050|Device|Negative Pressure Wound Therapy/ Wound VAC|Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 3,4,7,and 8 will receive iVAC therapy.
15891471|NCT03716050|Other|Fluorescent Angiography with indocyanine-green (not to exceed 5mg/kg)|Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 5,6,7,and 8 will receive angiography.
15891472|NCT03716050|Other|No treatment|Patient's will be randomized into one of eight groups and receive the intended treatment specified for that particular group. Groups 1 will include no treatment.
15891476|NCT03716011|Device|EXCROSSAL|a Second Generation Biodegradable Polymer Sirolimus-Eluting Stent
15891477|NCT03715998|Drug|Ramipril|1 or 2 capsules administered orally, twice daily
15891478|NCT03715998|Drug|Firibastat|1 or 2 capsules administered orally, twice daily
15891479|NCT03715985|Drug|EVAX-01-CAF09b|The personalised NPV-ds001 drug substance consists of multiple linear peptides (Pep-Ints) comprising natural L-amino acids dissolved in Dimethyl sulfoxide (DMSO) and 1 ml adjuvants (CAF09b) and 1,08 ml Tris buffer (25 ml).
15891480|NCT03715972|Drug|Hydroxyurea|info included in arm group
15891481|NCT03715972|Drug|Acetazolamide|Acetazolamide will not be considered a treatment; however, it will be used as a tool to help measure cerebralvascular reserve. A dose of 16 mg/kg ACZ will be administered with a maximum of 1400 mg.
15891482|NCT03715959|Procedure|Aspiration of Breast|Undergo NAF
15891483|NCT03715959|Procedure|Biospecimen Collection|Undergo NAF
15891484|NCT03715946|Drug|Nivolumab Injection|A fully human anti-programmed death 1 (PD-1) monoclonal antibody
15891485|NCT03715946|Radiation|Radiotherapy (RT)|45-50 Gy accelerated fractionation in 25 daily fractions, 6 fractions per week
15891486|NCT03715933|Drug|INBRX-109|Tetravalent DR5 Agonist Antibody
15891487|NCT03715933|Drug|Carboplatin|Chemotherapy
15891488|NCT03715933|Drug|Cisplatin|Chemotherapy
15891489|NCT03715933|Drug|Pemetrexed|Chemotherapy
15891490|NCT03715933|Drug|5-fluorouracil|Chemotherapy
15891491|NCT03715933|Drug|Irinotecan|Chemotherapy
15891492|NCT03715933|Drug|Temozolomide|Chemotherapy
15891493|NCT03715920|Device|Electrical currents|The training was planned as HVPG current for the the first group (n = 16), as Russian current for the second group (n = 15) and as isometric strengthening for the third group (n = 15). All treatments were performed under physiotherapist supervision for a total of 15 sessions for 3 days a week for 5 weeks.
15891494|NCT03715907|Behavioral|Financial Incentives|Incentives for gap closure.
15891495|NCT03715907|Behavioral|Information|Information on care gap and closure process.
15891496|NCT03715894|Procedure|transcatheter valve implantation|aortic transcatheter valve implantation using Edwards SAPIEN 3 valve
15891497|NCT03715881|Drug|Oral prednisolone administration 50 mg|50 mg oral prednisolone from the onset of the disease for 1 week, with the dose gradually reduced within 2 weeks and then discontinued
15891498|NCT03715881|Drug|Intravenous Erythropoietin injection|1000 units of erythropoietin every 12 hours for three days
15891499|NCT03715868|Other|Non-milked derived protein source formula diet|Formula diet based on a non-milked derived protein source
15891500|NCT03715855|Device|olfactory measuring device|"Patients blowing into bags then analysis by olfadiag system
~Patients blowing into sachets then analysis by olfadiag system"
15891501|NCT03715842|Other|Tub shaped design|The tub-shaped inlay preparation design this consists of an occlusal proximal reduction featuring a 3.5-4 mm width bucco-lingually, 3-3.5mm depth occluso-gingivally and 7-7.5 mm length mesio distally for molars and 2.3-2.8mm width buccolingually, 3-3.5 mm depth occluso gingivally and 3.5-4mm length mesiodistally for premolars. when necessary, superficial extensions may also be made on the preparations so that the occlusal fossa included in the preparation area and then the susceptibility for plaque accumulation will be diminished.
15891502|NCT03715842|Other|Inlay shaped design|The occlusal inlay had a preparation depth that allowed a thickness of 2.0 mm for the ceramic. The occlusal preparation was 4 mm wide and extended 4 or 6 mm mesio-distally for the premolar or molar models, respectively. The proximal box was 1 mm wide and had approximately 5˚ divergence, extending 2 mm apical to the isthmus floor . The preparations corresponded to a proximal connector area of 3 mm × 3 mm for molars and premolars.
15891503|NCT03715829|Drug|PF-06651600|Induction dose 1. Oral tablet taken QD
15891504|NCT03715829|Drug|PF-06651600|Induction dose 2. Oral tablet taken QD
15891505|NCT03715829|Drug|PF-06651600|Maintenance dose A. Oral tablet taken QD
15891506|NCT03715829|Drug|PF-06651600|Maintenance Dose B. Oral tablet taken QD
15891507|NCT03715829|Drug|PF-06651600|Maintenance Dose C. Oral tablet taken QD
15891508|NCT03715829|Drug|placebo|placebo
15891509|NCT03715829|Drug|PF06700841|Oral tablet taken QD
15891510|NCT03715829|Device|narrow-band UVB phototherapy|Phototherapy will be combined with PF-06651600
15891511|NCT03715816|Behavioral|Work break schedule|Participants will receive 2.5-min breaks during a 90-min simulated laparoscopic surgery in the laboratory. The breaks will be either passive (simple rest) or active (selected mobilization exercises).
15891512|NCT03715803|Device|Calistar A mesh to treat anterior and apical POP|Single incision surgery using Calistar A mesh to treat anterior and apical pelvic prolapses
15891513|NCT03715803|Device|Calistar S mesh to treat anterior and apical POP|Single incision surgery using Calistar S to treat anterior and apical pelvic prolapses
15891514|NCT03715790|Behavioral|EP referred group|Referred for sudden cardiac death (SCD) risk stratification and management
15891515|NCT03715790|Behavioral|Non-Referred group|Not referred for sudden cardiac death (SCD) risk stratification and management.
15891516|NCT03715777|Drug|Clostridium botulinum type A (BoNTA)|"Powder and solution for solution for injection Specify total dose: 80 U
~Route of administration:"
15891517|NCT03715764|Other|Physical therapy assessment|Primary assessment, diagnose and treatment by a physical therapist for patients with knee pain in primary care.
15891518|NCT03715764|Other|Physician assessment|Primary assessment, diagnose and treatment by a physician for patients with knee pain in primary care.
15891519|NCT03715751|Other|ASV|Adaptive Support Ventilation
15891520|NCT03715751|Other|Lung Protective Ventilation|Targeted tidal volume of 6cc/Kg, Positive Inspiratory Pressure titrated per ARDS guidelines.
15891521|NCT03715738|Other|arm 1 : Creaform3D + MyotonPRO|"After inclusion,are carried out:
~estimation of the volume of the breast to be reduced with the 3D digital camera
~measurement of breast density by Likert scale and MyotonPRO
~The volumetric measurement of the breast is performed using the 3D digital camera. The patient is bent forward with hands resting on a chair to be as still as possible over a period of 30 seconds to 1 minute. The 3D digital camera rotates around the breast to capture the volume of the breast.
~In peroperative, the weight of tissues removed is weighed (in grams). The removed weight is recorded in the observation notebook.
~In postoperative (4 months), the possible long-term complications related to the intervention (mainly the dissatisfaction of the patient as for the aesthetic result) are collected then a new acquisition of the mammary volume is carried out with the digital camera 3D.
~Once this measurement is completed, participation in the study is complete."
15891522|NCT03715725|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Administration according to clinical practice
15891523|NCT03715725|Drug|Apixaban (Eliquis)|Administration according to clinical practice
15891524|NCT03715725|Drug|Dabigatran etexilate (Pradaxa)|Administration according to clinical practice
15891525|NCT03715725|Drug|Warfarin (Marevan)|Administration according to clinical practice
15891526|NCT03715712|Other|standardized blood pressure management|Standardized blood pressure management of a mean blood pressure > 65mmHg and a systolic blood pressure of < 160mmHg using norepinephrine continuous infusion
15891527|NCT03715712|Other|Individualized blood pressure management|Individualized blood pressure management of 20% within the preoperative ward blood pressure using norepinephrine continuous infusion
15891528|NCT03715699|Drug|Prednisone|Prednisone: started with prednisone alone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, and maintained at 7.5mg to 10mg/d to 12 months.
15891529|NCT03715699|Drug|Prednisone and Leflunomide|"Prednisone: started with prednisone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, maintained at 7.5mg to 10mg/d to 12 months.
~Leflunomide: 20mg qd for 6 months and 10mg qd for 6 months."
15891530|NCT03715686|Procedure|wire localization|Pathologically proven positive axillary lymph node will be clip-marked before the initiation of neoadjuvant chemotherapy. After the completion of neoadjuvant chemotherapy, a wire will be placed to localize the clip-marked node before surgery. During surgery, a standard sentinel lymph node biopsy will be performed as well as the removal of the wire localized node. ALND will be performed in all participants.
15891531|NCT03715673|Diagnostic Test|von willebrand antigen and activity|Measuring von Willebrand antigen and activity (VWF: RCo and VWF: CB)
15891532|NCT03715660|Diagnostic Test|Xpert bladder cancer monitor|Xpert Bladder Cancer Monitor, is a qualitative in vitro diagnostic test designed to monitor for the recurrence of bladder cancer in patients previously diagnosed with bladder cancer.The test utilizes a voided urine specimen and measures the levels of five targetmRNAs (ABL1, CRH, IGF2, UPK1B, ANXA10) by means of real-time, reverse transcription-polymerase chain reaction (RT-PCR). The Xpert Bladder Cancer Monitor is indicated as an aid to standard clinical evaluation in monitoring for bladder cancer recurrence in patients previously diagnosed with bladder cancer and should be used in conjunction with other clinical measures to assess disease recurrence.
15891533|NCT03715647|Other|Sepsis|Evaluation and monitoring with Electrical Impedance Tomography in order to conduct ventilatory therapy.
15891534|NCT03715647|Other|HELLP Syndrome|Evaluation and monitoring with Electrical Impedance Tomography in order to conduct ventilatory therapy.
15891535|NCT03715647|Other|Respiratory Distress Syndrome Adult|Evaluation and monitoring with Electrical Impedance Tomography in order to conduct ventilatory therapy.
15891536|NCT03715634|Drug|INDV-6200|Subjects will be randomized in a 3:1 ratio to receive either depot buprenorphine or volume-matched placebo
15891537|NCT03715634|Drug|Placebo|Subjects will be randomized in a 3:1 ratio to receive either depot buprenorphine or volume-matched placebo
15891538|NCT03715634|Drug|SL Buprenorphine|All subjects will receive SL buprenorphine as non-investigational IMP to confirm tolerability
15891539|NCT03715634|Drug|Nalorex|Both Periods will include series of nalorex administrations to antagonize potential opioid effects from buprenorphine
15891540|NCT03715608|Other|Psychological Intervention|The patients in the intervention group received psychological counseling and corresponding medication after the operation. Psychotherapy was based on the clinical expertise of the psychosocial specialist from Peking University Sixth Hospital, who selected the most appropriate plan for each patient.
15891541|NCT03715595|Other|SSDM group|The patients can perform self-evaluation, including DAS28, morning stiffness duration (MSD) and HAQ, and input medical records (including medication and laboratory test results) every month.
15891542|NCT03715582|Drug|trimetazidine|Pills of masking drug - trimetazidine
15891543|NCT03715582|Drug|Placebo Oral Tablet|Pills of masking drug - placebo
15891544|NCT03715569|Diagnostic Test|Vestibular function|Vhit, Caloric test
15891545|NCT03715569|Diagnostic Test|OAE/WBT|Oto acoustic emissions Wide Band Tympanometry
15891546|NCT03715569|Diagnostic Test|Biomarker|Biomarker examination
15891547|NCT03715569|Diagnostic Test|MOCA, eGOS|Cognitive tests
15891548|NCT03715569|Diagnostic Test|Audiometry|Hearing test
15891549|NCT03715556|Drug|Amiodarone|Administration of the drug will be blinded within the first 48 hours for the principal investigator. Amiodarone (5 mg / kg EV in 30 minutes) will be the drug of choice in the Restricted group blinded to the principal investigator. If there is no reversal / control and there is no adverse event, a further dose of the same previously administered medicinal product will be performed within 30 minutes, amiodarone 3 mg / kg. After the second dose, continuous infusion of amiodarone at a dose of 900 mg in 24 hours will be initiated.
15891550|NCT03715556|Drug|0.9% physiological solution|Administration of 0.9% physiological solution.
15891551|NCT03715543|Procedure|Surgical Resection of the Greater Splanchnic Nerve|"Video-Assisted Thoracoscopic Surgery (VATS) is performed under general anesthesia using existing, CE marked instrumentation. Two or more 5 mm incisions are used to pass a tiny video camera and a single dissecting instrument into the chest. These small ports are advantageous because the chance for infection and wound dehiscence are drastically reduced. This allows for a faster recovery by the patient and a greater chance for the wound to heal.
~In the procedure the GSN will be identified visually or through stimulation-induced hemodynamic reflex. The GSN will then be ablated using standard techniques. If there are multiple branches of the GSN, each branch will be systematically identified and ablated."
15891552|NCT03715530|Device|PAMG-1 immunoassay|The procedure includes the insertion of a PAMG-1 swab into the subject's vaginal vault without a speculum for one minute. Once the swab is obtained, the treating physician will place the swab in a solvent vial for one minute. A developing strip is then placed in a vial and allowed to develop for five minutes. The results are read from the developing strip.
15891553|NCT03715517|Procedure|Continuous thoracic epidural analgesia|"Needle/catheter: 17 Ga. × 80 mm Tuohy epidural needle (Perican®, B. Braun Medical Inc., Bethlehem, PA, USA); Arrow FlexTip Plus® 19 Ga. epidural catheter (Arrow International Inc., Reading, PA, USA)
~Level of insertion and patient positioning: T6-T8, upright sitting position for insertion of needle and catheter (to 5 cm beyond loss-of-resistance point) and for injection of test dose (3 mL 2% lidocaine with epinephrine 1:200,000); supine for injection of bolus dose
~Confirmation of correct placement: Loss of resistance to air or saline; negative aspiration of the epidural catheter; negative test dose; and ease of injection of an initial bolus dose"
15904431|NCT03615105|Drug|Clofarabine|Clofarabine 20-30 mg/m2 IV
15891554|NCT03715517|Procedure|Spinal anesthesia with intrathecal morphine|"Needle/catheter: 25 Ga. × 90 mm high-flow Whitacre spinal needle (Becton-Dickinson, Franklin Lakes, NJ, USA)
~Level of insertion and patient positioning: L2-L3, lateral decubitus position during injection; immediately post-injection, patient is placed supine in <5% degree of Trendelenburg
~Confirmation of correct placement: Aspiration of cerebrospinal fluid"
15891555|NCT03715517|Drug|Bupivacaine 0.75% in Dextrose Inj 8.25%|0.25 mg⋅kg-¹ hyperbaric bupivacaine 0.75%
15891556|NCT03715517|Drug|Morphine|3 mcg⋅kg-¹ intrathecal morphine (preservative-free)
15891557|NCT03715517|Drug|Bupivacaine 0.25% Preservative-Free Injectable Solution|0.25 mg⋅kg-¹ bupivacaine 0.25%
15891558|NCT03715517|Drug|Bupicavaine 0.125% epidural solution|Epidural solution, bupivacaine 0.125% with hydromorphone 10 mcg·mL-¹, infusion range 0.075-0.125 mL⋅kg-¹⋅h-¹
15891559|NCT03715517|Drug|Hydromorphone 10 mcg/mL epidural solution|Epidural solution, bupivacaine 0.125% with hydromorphone 10 mcg·mL-¹, infusion range 0.075-0.125 mL⋅kg-¹⋅h-¹
15891560|NCT03715504|Drug|TP-3654|oral PIM inhibitor
15891561|NCT03715478|Drug|GSK2857916 with Pomalidomide and Dexamethasone|Recommended phase 2 dose (RP2D) of GSK2857916 determined by the phase 1 portion of study will be administered in combination with pomalidomide (approved dose and schedule) and dexamethasone until progression of disease.
15891564|NCT03715452|Device|DyeVert Plus Contrast Reduction System|The DyeVert Plus System interfaces with standard manifold systems to provide real-time contrast monitoring and reduce the amount of contrast used in catheterization procedures while maintaining fluoroscopic image quality. System components include a disposable, single-use, sterile DyeVert Plus Disposable Kit that contains a Smart Syringe and DyeVert Plus Module, which is connected to a standard manifold and provides fluid pathway resistance modulation via a dedicated diversion valve. The diversion valve self-adjusts to the manual injection pressure to divert some of the contrast media into the reservoir chamber within the module. This diverted volume of contrast media does not enter the patient.
15891565|NCT03715439|Device|Dental implant|A single dental implant was inserted 3 months after tooth extraction
15891566|NCT03715426|Behavioral|MKit|MKit is a web-based application that uses a life-skills approach to address healthy relationships and sexual violence. It includes 14 tiles which incorporate information, goal setting, and resources.
15891567|NCT03715413|Other|pulsed radiofrequency of 2nd , 3rd and 4th thoracic dorsal root ganglia.|Patients were lying prone. Firstly, T2, 3, 4 disc level was detected then the target 2nd, 3rd and 4th thoracic nerve roots were identified. After marking the entry points, adequate sterilization of the skin was achieved using bovidone iodine then the skin was anasthesied by 2 ml lidocaine 2% at each entry point. The Baileys radio frequency (RF) 22G, 10 cm, sharp needles with 10 mm active tip was introduced to face the 2nd, 3rd and 4th thoracic nerve roots.The PRF course was carried out at 42°C for 120 s twice at each level followed by injection of 1 ml lidocaine 2% and 1 ml dexamethasone 4 mg at each level.
15891568|NCT03715413|Drug|Tamoxifen|received Tamoxifen 10 mg daily
15891569|NCT03715400|Behavioral|Positive Virtual Reality Training|Participants will undergo 7 45 minute sessions of positive virtual reality training over the course of four weeks. All assessments will be completed online at home following initial orientation to the program.
15891570|NCT03715387|Drug|Tacrolimus Topical 0.1% Topical Ointment|Topical tacrolimus ointment
15891571|NCT03715387|Drug|Polysporin Ointment|Polysporin ointment
15891572|NCT03715374|Procedure|Periodontal Surgery with PRF+ABB|Patients will be treated by periodontal surgical flaps with the addition of PRF+ Anorganic Bovine Bone filling material
15891573|NCT03715374|Procedure|Periodontal Surgery with Collagen Membrane +ABB|Patients will be treated by periodontal surgical flaps with the addition of Collagen Membrane + Anorganic Bovine Bone filling material
15891574|NCT03715361|Diagnostic Test|SL-ECG|additional SL-ECG measurement
15891575|NCT03715348|Drug|Prothrombin Complex Concentrate (PCC)|PCC is a blood product produced through pooling of thousands of human plasmas, which is then treated to inactivate enveloped viruses. From the pooled plasma, vitamin K dependent clotting factors (factors II, VII, IX and X, and protein C and protein S), are selected to produce the concentrated form called PCC.
15891576|NCT03715348|Biological|Fresh Frozen Plasma|Fresh Frozen Plasma a blood component manufactured from whole blood collection.
15891577|NCT03715335|Other|Targeted STI Screening|GC/CT screening will be offered to those who screen at risk or at high risk for STIs.
15891578|NCT03715335|Other|Universally Offered STI Screening|GC/CT screening will be offered to all patients who meet the age eligibility criteria.
15891579|NCT03715322|Drug|Tobramycin Inhalant Product|Tobramycin will be nebulized (300mg twice daily) with an ultrasonic nebulizer. A total of two 28-day on-and-off cycles will be scheduled.
15891580|NCT03715322|Other|usual care|ambroxool (30mg thrice daily), or N-acetylcysteine (0.2g thrice daily) plus chest physiotherapy (5 min, once daily)
15891581|NCT03715322|Drug|Natural saline inhalation|Natural saline will be nebulized (5ml twice daily) with an ultrasonic nebulizer. A total of two 28-day on-and-off cycles will be scheduled.
15891582|NCT03715309|Drug|Revlimid|Revlimid 25mg PO d1-10 Plus Rituximab 375 mg/m2 IV d0
15891583|NCT03715296|Drug|Lenalidomide 25mg|Lenalidomide 25mg/d PO d1-10 Plus Rituximab 375 mg/m2 IV d1, Cyclophosphamide 750mg/m2 IV d2, Doxorubicin 50mg/m2 IV d2, Vincristine 1.4 mg/m2 IV d2, Prednisone 60 mg/m2 PO d2-6 OR Ifosfamide 1500mg/m2/d iv d1-3, Carboplatin 5*[GFR(ml/min)+25]mg/d iv d2, Etoposide 100mg/m2/d iv d1-3,
15891584|NCT03715283|Other|Home Ankle Strengthing Program|Patients in this arm will be given a USB or DVD video with description of ankle dorsi- and plantar- flexion resistance band exercise. They will also be given an outlined plan for there exercises, progression and an exercise diary. In general patients will start with a low resistance and low reps, over the 4 weeks they will increase the repetitions at the same resistance band. After the 4 weeks they will have the option to escalate the band resistance or continue at the same resistance and repetitions until comfortable progressing. The same 4 week progression will be used for each resistance band over the 12 weeks.
15891585|NCT03715283|Other|Standard of Care|Patients in this arm will be directed to continue there standard care program. They will be asked to refrain from resistance exercise for 12 weeks.
15891586|NCT03715270|Device|Image surgical area|Image surgical area
15891587|NCT03715257|Device|14F staged extubation set guidewire|"14F staged extubation set guidewire is a single use supraglottic airway device. This airway device provides access and functional separation of the respiratory and digestive tracts.
~Cough, straining, hemodynamic parameters and occurrance of hypoxemia (SpO2<94%) are recorded for the first 20 postoperative minutes. Blood gas analyses are done before extubation and 15 minutes after placement of the extubation catheter.
~The patients are randomly distributed into two groups; one with 14F staged extubation set guidewire (n=50)"
15891588|NCT03715257|Device|Tube changing catheter|"Tube changing catheter Tube changing catheter is an alternative extubation device. Cough, straining, hemodynamic parameters and occurrance of hypoxemia (SpO2<94%) are recorded for the first 20 postoperative minutes. Blood gas analyses are done before extubation and 15 minutes after placement of the extubation catheter.
~The patients are randomly distributed into two groups; one with 14F staged extubation set guidewire (n=50)"
15891589|NCT03715244|Procedure|Spinal anesthesia with short-acting local anesthetics|Spinal anesthesia in patients with duration of surgery < 90 minutes
15891590|NCT03715244|Procedure|General anesthesia (current standard)|General anesthesia in patients with duration of surgery < 90 minutes
15891591|NCT03715231|Diagnostic Test|NIDEK Gonioscope GS-1|To determine inter-observer repeatability when using this device, two observers will examine each image obtained from NIDEK Gonioscope GS-1 and separately determine the iridocorneal angle. Inter-observer repeatability will be tested using Pearson correlation.
15891592|NCT03715231|Diagnostic Test|Standard Digital Gonioscopic Images|To determine inter-observer repeatability when using this device, two observers will examine each image obtained from NIDEK Gonioscope GS-1 and separately determine the iridocorneal angle. Inter-observer repeatability will be tested using Pearson correlation.
15891593|NCT03715218|Other|Mothers Touch Program|Mothers Touch Program with bed rest, Relaxation program to reduce stress, massage for mother and infant, gently physical exercise and special dietary program each week.
15891594|NCT03715218|Other|Usual Care Program|Usual care group had advice, support and educational program delivered by midwife, or physicians.
15891595|NCT03715205|Drug|Pembrolizumab|Administered as an intravenous (IV) infusion every 3 weeks (Q3W)
15891596|NCT03715192|Biological|LY3462817 IV|Administered IV
15891597|NCT03715192|Biological|LY3462817 SC|Administered SC
15891598|NCT03715192|Drug|Placebo|Administered IV
15891599|NCT03715179|Device|Ostomy Pouching System|An ostomy pouching system is a medical device that provides a means for the collection of effluent from a surgically diverted biological system (colon, ileum, bladder) and the creation of a stoma. No intervention is administered during the course of this study.
15891600|NCT03715166|Drug|Bumetanide Oral Solution|Oral Solution dosed at 0.5mg/mL Taken twice daily
15891601|NCT03715166|Drug|Placebo|Oral Solution Taken twice daily
15891602|NCT03715153|Drug|BUMETANIDE/S95008|Oral solution dosed at 0.5 mg/mL Taken twice daily.
15891603|NCT03715153|Drug|PLACEBO|Oral solution Taken twice daily.
15891604|NCT03715140|Drug|Crucumin|Evaluation of the effect of Crucumin in patients with osteoarthritis
15891605|NCT03715140|Drug|Placebo|Placebo
15891606|NCT03715127|Drug|Psilocybine oral capsule|single dose of psilocybin (0.215mg / kg body weight)
15891607|NCT03715127|Drug|Placebo oral capsule|single dose of placebo (100% mannitol)
15891608|NCT03715114|Drug|GV-971|Oral GV-971
15891609|NCT03715114|Drug|Placebo|Oral Placebo
15891610|NCT03715101|Drug|Rosuvastatin|Open-label, one-sequence, multiple administration
15891611|NCT03715088|Behavioral|Resistance Training Intervention|Participants will perform 10 different resistance exercises consisting of three sets of 8-10 repetitions, at 80% of 1-RM, separated by 60-second rest intervals between sets. This exercise protocol was chosen based on literature that suggests that the protocol and intensity do not enhance mitochondria biogenesis. Also, it was well tolerated by obese and older individuals.
15891612|NCT03715075|Procedure|Caesarean Section|Caesarean Section
15891613|NCT03715062|Other|Dialogue tool|The intervention has two parts: an educational session and a dialogue tool. The educational session consists of 75 minutes of education in diagnosing urinary tract infection. The dialogue tool consists of 1) a checking box for the most important symptoms and observations for urinary tract infection 2) an algorithm to evaluate if urinary tract infection is likely based on the present symptoms and observations 3) a list of reflection points to evaluate with a collegue 4) a specialized ISBAR (communication tool) if long-term care facility staff finds it appropriate to contact the General Practicioner
15891614|NCT03715049|Procedure|Fraxel Laser Treatment|The device to be used in this study is a FDA approved device [510(k) approval] used for aesthetic dermatological procedures. The Fraxel Repair laser system utilizes a sealed off, all metal carbon dioxide gas tube that is radio frequency (RF) excited and air cooled, emitting light at a wavelength of 10.6 μm with programmable pulse duration and frequency. The Fraxel Repair laser has a continuous motion (rolling) optical tracking system. The Fraxel system consists of a treatment component and an internal control component. The treatment component consists of the laser delivery handpiece. A computer with a touch screen keyboard to enter subjects' information also provides controls for the fractionated delivery of the 10.6 μm beam.
15891615|NCT03715036|Diagnostic Test|Point-of-care US|The intervention includes reassuring the AC and DVP
15891616|NCT03715023|Drug|PC786|PC786 suspension for inhalation
15891617|NCT03715023|Drug|Placebo|Placebo solution for inhalation
15891618|NCT03715023|Drug|SOC|Standard treatment for RSV infection at study site
15891619|NCT03715010|Dietary Supplement|BCAA|Subjects will be randomly assigned to take either the 25g supplement (containing 4g BCAA) daily for 4 weeks followed by the 20g BCAA supplement daily for 4 weeks, or vice versa
15891620|NCT03714997|Procedure|Walking training|Practice of walking training in variable contexts, including multiple tasks and environments specific to the patients' deficits and community walking goals.
15891621|NCT03714984|Other|Pre operative exercise|After randomization participants will be allocated in two groups. The educational pelvic floor intervention group will receive two months before surgery a physiotherapy visit were will be explain to patients and care giver the pelvic floor anatomy and biomechanics and how perform the exercises to be follow at home focusing on pelvic muscles awareness and contraction.
15891622|NCT03714984|Other|Control Group|The control group will be just informed about the study protocol and will not receive any pre-operative intervention.
15891623|NCT03714971|Behavioral|WhatsApp embedded in smoking cessation service|The routine service delivery was ongoing as the intervention was conducted. In addition to the routine procedures in service delivery described above, WhatsApp messages were sent according to the plan.
15891624|NCT03714958|Drug|HDM201|Treatment will be administered as long as patient experience clinical benefit in the opinion of the investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
15891625|NCT03714958|Drug|Trametinib|Treatment will be administered as long as patient experience clinical benefit in the opinion of the investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
15891626|NCT03714945|Other|No intervention|No intervention is required as this study is observational.
15891627|NCT03714932|Diagnostic Test|3shape ortho analyzer software|Arch analysis , manual analysis , digital analysis , Mixed dentition , Tanaka and Johnston
15891628|NCT03714919|Drug|Dextromethorphan|Preoperative oral dextromethorphan 1 mg/kg
15891629|NCT03714919|Drug|Acetaminophen|Preoperative oral acetaminophen 15 mg/kg
15891630|NCT03714919|Drug|Dexmedetomidine|Intraoperative intravenous dexmedetomidine 0.5 μg/kg
15891631|NCT03714919|Drug|Ketamine|Intraoperative intravenous ketamine 0.5 mg/kg
15891632|NCT03714906|Procedure|Stellate ganglion block|Stellate ganglion block will consist of an injection of 0.25% bupivacaine placed under ultrasound guidance by a trained anesthesiologist in the pre-operative holding area prior to surgery.
15891633|NCT03714893|Device|Sensor wrist watch|Participants will wear a sensor wrist watch which will collect data
15891634|NCT03714880|Drug|Mifepristone 200 MG|Ingestion of study medication vs placebo
15891635|NCT03714880|Drug|Placebo Oral Tablet|Ingestion of study medication vs placebo
15891636|NCT03714867|Drug|Pregabalin 150mg|150 mg concealed pregabalin capsule
15891637|NCT03714867|Other|Placebo|Concealed placebo capsule
15891638|NCT03714854|Device|transcranial magnetic stimulation|TMS will be delivered on the sensory-motor system and the inhibitory motor control network while patients are performing behavioral and motor tasks. Brain and muscle activity will be recorded concurrently using EEG and EMG respectively.
15891639|NCT03714841|Other|CRP|Knowledge of CRP value
15891640|NCT03714828|Drug|Injection of TVEC into target lesions - week 1-2|"Target lesions are identified and documented with measurements and photographs. Photographs will be taken with regional and close up view of the anatomical area and lesion.
~Inject 0.5ml - 4ml (based on lesion size - section 7.1, Table 5) Talimogene laherparepvec at nominal concentration of 106 plaque forming units (PFU)/mL with approximately 1.15 mL in a 2 mL vial for the initial dose. This will be administered intralesionally to 1-3 cSCC lesions per anatomical site with a maximum of 5 injectable lesions per patient."
15891641|NCT03714828|Drug|Injection of TVEC into target lesions 3wks after 1st injection|"Target lesions are identified and documented with measurements and photographs. Photographs will be taken with global and close up view of the anatomical area and lesion.
~Inject 0.5ml - 4ml (based on lesion size) and number of lesions selected. Talimogene laherparepvec at nominal concentration of 108 PFU/mL withapproximately 1.15 mL in a 2 mL vial for the second and subsequent doses."
15891642|NCT03714828|Drug|Injection of TVEC into target lesions 2wks after 2nd injection|"Target lesions are identified and documented with measurements and photographs. Photographs will be taken with global and close up view of the anatomical area and lesion.
~Inject 0.5ml - 4ml (based on lesion size) and number of lesions selected.Talimogene laherparepvec at nominal concentration of 108 PFU/mL with approximately 1.15 mL in a 2 mL vial for the subsequent doses."
15891643|NCT03714828|Drug|Injection of TVEC into target lesions 2wks after 3rd injection|"Target lesions are identified and documented with measurements and photographs. Photographs will be taken with global and close up view of the anatomical area and lesion.
~Inject 0.5ml - 4ml (based on lesion size) and number of lesions selected. Talimogene laherparepvec at nominal concentration of 108 PFU/mL with approximately 1.15 mL in a 2 mL vial for the subsequent doses."
15891645|NCT03714802|Procedure|Szabo T-Stenting Technique|2-stent strategy was performed using modified T-stenting with Szabo technique in bifurcation lesions. First, stent was implanted in the side branch with Szabo technique. Then, stent was implanted in the main branch. Finally, kissing balloon inflation was performed.
15891646|NCT03714802|Procedure|T-Stenting Technique|2-stent strategy was performed using traditional T-stenting technique in bifurcation lesions. First, stent was implanted in the side branch with angiographic guidance. Then, stent was implanted in the main branch. Finally, kissing balloon inflation was performed.
15891647|NCT03714789|Other|Blood and spent dialysate collection|A certain amount of blood and spent dialysate are collected during and after dialysis for quantification of drug concentration.
15891648|NCT03714776|Drug|IONIS-AGT-LRx|IONIS-AGT-LRx injected subcutaneously once-weekly
15891649|NCT03714776|Drug|Placebo|Placebo matching solution injected subcutaneously once-weekly
15891650|NCT03714763|Drug|Drug treatment|Subjects who show high expression of dopamine D2 receptors in PET-MR imaging will be treated with Cabergoline(CAB) tablets 2mg/week or bromocriptine(BC) tablets 7.5mg/ day.The pituitary hormone levels, tumor volume, visual acuity and visual field scale will be measured every 3 months. The medication will be stopped if failure to decrease tumor size and the subjects will be advised to surgical therapy.
15891651|NCT03714763|Other|Surgery|Subjects who show low expression of dopamine D2 receptors in PET-MR imaging will be treated with endoscopic transphenoidal pituitary surgery .
15891652|NCT03714750|Procedure|DK crush|revascularization of true coronary bifurcation stenosis in DK crush technique
15891653|NCT03714750|Procedure|Reverse TAP|revascularization of true coronary bifurcation stenosis in Reverse TAP technique
15891654|NCT03714737|Biological|experimental vaccine|bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine(OLYMVAX Biological Co., LTD)
15891655|NCT03714737|Biological|Positive control vaccine 1|bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine(WALVAX Biological Co., LTD)
15891656|NCT03714737|Biological|Positive control vaccine 2|bivalent meningococcal serogroups A and C tetanus toxoid conjugate vaccine(Royal (Wuxi) Biological Co., LTD)
15891657|NCT03714724|Diagnostic Test|Intraabdominal Pressure Measurement|In this method, a sterile set system (AbViser- Wolfe Tory Medical, Saik Lake City, Utah, USA) was used in normal conditions. Measurements will be made in 20 ml saline was given, Pressure transducer was used as a reset point pubic symphysis and intra-abdominal pressure was measured.
15891658|NCT03714711|Procedure|total hip arthroplasty|Total hip replacement
15891659|NCT03714711|Procedure|total knee arthroplasty|Total knee replacement
15891660|NCT03714698|Other|Pilates exercise group|Pilates exercise group participated in supervised Pilates-based group training twice per week for six weeks
15891661|NCT03714698|Other|Control Group|The control group participated in a routine non-specific activity program twice a week in Community Mental Health Center during study
15891662|NCT03714685|Drug|Firibastat|Firibastat (QGC001) 500 mg
15891663|NCT03714672|Drug|Tramadol/Diclofenac 50/50|Each dose comprised 1 fixed-dose combination tablet and 3 placebo tablets or capsules matching the other active treatment groups. Doses were taken 8 hours apart.
15891664|NCT03714672|Drug|Tramadol/Diclofenac 25/25|Each dose comprised 1 fixed-dose combination tablet and 3 placebo tablets or capsules matching the other active treatment groups. Doses were taken 8 hours apart.
15891665|NCT03714672|Drug|Tramadol 50|Each dose comprised 1 capsule containing 50 mg tramadol hydrochloride and 3 placebo tablets matching the other active treatment groups. Doses were taken 8 hours apart.
15891666|NCT03714672|Drug|Diclofenac 50|Each dose comprised 1 tablet containing 50 mg diclofenac sodium and 3 placebo tablets or capsules matching the other active treatment groups. Doses were taken 8 hours apart.
15891667|NCT03714659|Device|Lipogems|Lipogems is a closed-loop system designed to break up adipose tissue into micro-fragmented adipose tissue without additives; therefore, meeting FDA requirements for minimal manipulation. A small volume of adipose tissue is harvested from the abdomen, thigh, or other location. The lipoaspirate is fed into the device through a reduction filter, and is then cleansed of blood and oil residues using a sterile saline solution. This fat-saline solution is then shaken for 30 seconds in a device containing stainless steel ball bearings, which further fragments and washes the lipoaspirate. Once the tissue is purified and fragmented, it is collected in 10cc sterile syringes and subsequently injected into the meniscus and knee joint.
15891668|NCT03714646|Dietary Supplement|beta glucan and resistant starch|12g per day the day before the CID Resistant starch 7.5 g
15891669|NCT03714646|Dietary Supplement|Placebo|isocaloric maltodextrin before the CID
15891670|NCT03714646|Dietary Supplement|beta gluten|12 g beta gluten there day before the CID
15891671|NCT03714633|Behavioral|Stockholm Preterm Interaction-Based Intervention (SPIBI)|Post-discharge intervention to extreme premature infants and their parents
15891672|NCT03714620|Drug|Ketamine|Ketamine 0.15 mg/kg vs. 0.3 mg/kg IVPB over 15 minutes
15891673|NCT03714607|Device|Erbium Yttrium Aluminum Garnet (Er:YAG) laser|5 Er:YAG laser therapies vaginally administered at monthly intervals
15891674|NCT03714594|Drug|Dapagliflozin 10mg|Dapagliflozin inhibits subtype 2 of the sodium-glucose transport proteins (SGLT2) which are responsible for at least 90% of the glucose reabsorption in the kidney. Blocking this transporter mechanism causes blood glucose to be eliminated through the urine.[
15891675|NCT03714594|Drug|Saxagliptin 5mg|Inhibits DPP-4 and slows inactivation of incretin hormones, thereby increasing blood concentrations and reducing fasting and postprandial glucose concentrations in a glucose-dependent manner in patients with type 2 diabetes mellitus
15891676|NCT03714594|Drug|Saxagliptin 5mg + Dapagliflozin 10 mg|Please see Intervention 1 and 2
15891677|NCT03714581|Device|Microablative Fractional CO2 Laser Therapy|5 laser therapies intravaginally administered will be applied at monthly intervals.
15891678|NCT03714568|Drug|TQ-A3326|TQ-A3326 (15mg-180mg: p.o. single dose; 60mg: p.o. multi-doses）
15891679|NCT03714568|Drug|placebo|Placebo(15-180mg: p.o. single dose; 60mg: p.o. multi-doses)
15891680|NCT03714555|Diagnostic Test|Safety Laboratories|CBC w Differential, CMP, PT/INR, aPTT, Urinalysis
15891681|NCT03714555|Other|AE Assessment|Assessment of Adverse Events
15891682|NCT03714555|Other|Physical Exam|Physical Exam, Weight, Vital Signs, ECOG Performance Status
15891683|NCT03714555|Other|Concomitant Medication Review|Prior and Concomitant Medication Review
15891684|NCT03714555|Diagnostic Test|Tumor Imaging|Tumor CT or MRI
15891685|NCT03714555|Drug|nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) Protocol Plus Disulfiram/Copper Gluconate|nab-paclitaxel (Abraxane)/gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
15891686|NCT03714555|Drug|FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate|FOLFIRINOX regimen Plus Disulfiram/Copper Gluconate dispensing
15891687|NCT03714555|Drug|Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate|Single-agent gemcitabine (Gemzar) regimen Plus Disulfiram/Copper Gluconate dispensing
15891688|NCT03714542|Other|Pre- and postoperative MRI|
15891689|NCT03714529|Biological|PD-L1|IO103 is a anti-cancer therapy consisting of a synthetic PD-L1-derived peptide.
15891691|NCT03714503|Device|Retina re-attachment repair using C3F8 gas tamponade|Assigning a one day post-operative head positioning
15891692|NCT03714490|Radiation|SCPRT plus neoadjuvant chemotherapy|Short-course preoperative radiotherapy(SCPRT) with neoadjuvant chemotherapy, which consists of SCPRT, 5 Gy x 5, 4Gy for boost on the GTV with MRI-simulation alone, then after 7-10 days of radiotherapy completed, patients will receive consolidation chemotherapy, given in 3 week cycle of capecitabine 1000 mg/m2 twice daily, day 1-14 combined with oxaliplatin 130 mg/m2 once. In total, 4 cycles of neoadjuvant chemotherapy are scheduled before surgery.
15891693|NCT03714490|Radiation|long course chemoradiation|Long-term chemoradiotherapy(CRT), which consists of a long-term chemoradiation (2 Gy x 25 with capecitabine) preoperatively.
15891694|NCT03714477|Procedure|Extracorporeal shock wave lithotripsy|A minimally invasive treatment for renal stone which was first introduced in early 1980's. It tries to fragment the renal stones by high-energy shockwave at the kidney from the outside.
15891695|NCT03714464|Other|Whole apples|350 of whole apples containing 49g of available carbohydrate with 173ml water
15891696|NCT03714464|Other|Apple puree|384g of apple puree containing 44g of available carbohydrates with 224 ml water
15891697|NCT03714464|Other|Apple Juice|338g apple juice containing 46g of available carbohydrate with 260 ml water
15891698|NCT03714451|Dietary Supplement|onyx sorghum|The diet intervention will last a total of 28 days. Per the American Heart Association (AHA) and American Diabetes Association (ADA) recommendations, the daily diet plan will consist of 50-55% carbohydrate, 15-20% protein, and 25-30% fat. In the Onyx Group, 25% of carbohydrate will come from the onyx sorghum, and at least three foods per day (including cereals, bread, muffins, pasta, and smoothie boosters) will contain this.
15891699|NCT03714451|Dietary Supplement|whole wheat flour|Per the American Heart Association (AHA) and American Diabetes Association (ADA) recommendations, the daily diet plan will consist of 50-55% carbohydrate, 15-20% protein, and 25-30% fat.
15891700|NCT03714438|Drug|Medicago Sativa|Single oral doses of Medicago sativa (1,500 mg), 30 min before before the oral glucose tolerance test.
15891701|NCT03714438|Dietary Supplement|Placebo|Single oral doses of placebo (1,500 mg), 30 min before before the oral glucose tolerance test.
15891702|NCT03714425|Device|Quell|Quell is a Transcutaneous Electrical Nerve Stimulator Device (TENS). The device will use nerve stimulation to treat chronic pain by sending signals to the brain that cause it to release natural opioids.
15891703|NCT03714412|Device|Implantation|Implantation of the Cardiovalve transfemoral mitral valve replacement system
15891704|NCT03714386|Device|A synthetic high-flux dialyzer will be used for OL-HDF.|A synthetic high-flux dialyzer used for OL-HDF must be implemented following current clinical practices guidelines and procedures at the hospital. No additional actions are required. General rules will be applied regarding dialysis prescription
15891705|NCT03714386|Device|A medium cut-off dialyzer will be used for HDx.|A medium cut-off dialyzer used for HDx must be implemented following current clinical practices guidelines and procedures at the hospital. No additional actions are required. General rules will be applied regarding dialysis prescription
15891706|NCT03714373|Drug|DCCR|Once daily oral administration
15891707|NCT03714360|Drug|Tranexamic Acid|patients with ASA(American Society of Anesthesiologists grades) 1 to 2, scheduled to undergo lumbar decompressive surgery at Middelfart Hospital. Patients were randomized, in blocks of 10, to two groups: TXA or placebo. Anticoagulation therapy was discontinued 2-7 days preoperatively. Prior to the incision, patients received either a bolus of TXA (10mg/kg), or an equivalent volume of saline solution (placebo).
15891708|NCT03714360|Drug|Sodium Chloride 0,9%|Sodium Chloride 0,9%
15891709|NCT03714347|Device|cerebral oxygen monitoring|probes will be placed on eyebrows on forehead
15891710|NCT03714347|Device|routine monitoring|We will use routine monitoring intervention such as hate rate, arterial pressure, BIS. cerebral oxygen monitoring will not be applied to this group
15891711|NCT03714334|Drug|DNX-2440 injection|DNX-2440 virus will be injected stereotactically
15891712|NCT03714321|Device|Mechanical insufflation-exsufflation (MIE)|Randomization of 30 patients, 15 in each arm, to receive either CPAP or MIE.
15891714|NCT03714295|Other|Use of interdental brushes|No intervention they just use interdental brushes as it should be done routinely
15891715|NCT03714282|Device|Noninvasive spinal stimulation with gait training|Transcutaneous Spinal Cord Neurostimulator will deliver transcutaneous electrical spinal cord stimulation while subjects perform locomotor activities.
15891716|NCT03714282|Device|Conventional gait training|May receive up to 50 min of locomotion training without transcutaneous spinal cord stimulation. However, the amount of time spent in side-lying locomotion training, treadmill training and overground training will depend on individual tolerance and progression.
15891717|NCT03714282|Other|Healthy control group|Participant in the Healthy Control Group will participate in up to 3 assessment sessions in order to obtain comparative data for Spinal Motor Evoked Potentials (MEPs), lower extremity MVC's, sidelying EMG data and overground EMG data
15891718|NCT03714269|Other|measurement evaluated with an isokinetic dynamometer|measurement of the maximum dorsiflexion angle in degrees evaluated on an isokinetic dynamometer
15891719|NCT03714269|Other|measurement evaluated with an 2D ultrasound|"simultaneous recording of force torque, joint angle and myotendinous junction displacement in 2D ultrasound during 5 passive mobilization cycles of ankle flexion-extension at very low speed
~recording of static images in 2D ultrasound representing the proximal insertion of the gastrocnemius muscle in the internal condyle of the femur, the myotendinous junction."
15891720|NCT03714269|Other|assessment of the level of discomfort|visual analogue scale (0 = no discomfort and 10 = maximal discomfort)
15891721|NCT03714256|Device|Device, patient mobility, powered|Pediatric mobility device
15891722|NCT03714243|Device|ExAblate BBBD|Using ExAblate Model 4000 Type-2 to temporarily disrupt the blood brain barrier in patients with Her-2 positive breast cancer and brain metastases
15891723|NCT03714217|Behavioral|Telenutrition Counseling|A registered dietitian nutritionist will contact each participant twice a month for 3 months to provide nutrition counseling via iPad FaceTime.
15891724|NCT03714204|Behavioral|Transcendental Meditation technique|The TM technique is a simple mental procedure that is categorized in the automatic self-transcending category of meditation practices. It is automatic in that it does not involve any concentration or control. It allows the mental activity to settle down in a spontaneous and natural manner during a process called transcending, or going beyond, until it reaches a state beyond conscious thinking. Correspondingly, the body settles down to a deep state of rest which allows stress to dissolve and the nervous system to rejuvenate The effortless nature of the TM practice coupled with the vast research supporting its efficacy, its systematic standardized teaching program and the fact that it does not involve any belief or change in one's lifestyle made it the choice intervention for this research.
15891725|NCT03714191|Other|Patient Outcomes|The intervention includes different versions of the BPA design and message.
15891726|NCT03714191|Other|Billing documentation|The intervention includes different versions of the BPA design and message.
15891727|NCT03714191|Other|Regulatory|The intervention includes different versions of the BPA design and message.
15891728|NCT03714178|Device|FARAPULSE Endocardial Ablation System|Endocardial ablation using the FARAPULSE Endocardial Ablation System.
15892103|NCT03711240|Drug|Oxaliplatin|85mg/m2 2-hour iv infusion, day 1 every 2 weeks
15891729|NCT03714165|Diagnostic Test|Alpha defensin and 16SrRNA gene|Alpha defensin 16S rRNA gene CBC: Complete blood count CRP: C reactive protein ESR: Erythrocyte sedimentation rate Culture and antibiotic sensitivity of synovial fluid
15891730|NCT03714152|Drug|ABI-H2158|5 mg or 25 mg tablets
15891731|NCT03714152|Drug|Placebo for ABI-H2158|Sugar pill manufactured to mimic the ABI-H2158 5 mg or 25 mg tablets
15891732|NCT03714139|Procedure|immediate loading|"The participants will be assigned to immediate or delayed functional loading groups. In each participant, edentulous areas with adequate thickness of the alveolar bone crest will be identified and at least two sites will be identified for implant installation. All implant recipient sites will be sub-prepared to allow good stability of the implants. Experimental mini-implants (Sweden & Martina, Due Carrare, Padova, Italy), 3.5 mm in diameter and with an intraosseous portion of 4 mm in length will be installed.
~Immediate loading group - A prosthetic component will be applied over the trial implants. Impressions will be taken and a crown / bridge will be provided to patients in one day."
15891733|NCT03714139|Procedure|non implant loading|Control implants will receive a healing screw and will remain unloaded
15891734|NCT03714126|Device|Cordio Medical|Recording to an app, no interference to the regular care
15891735|NCT03714113|Diagnostic Test|Anti-HLA donor-specific antibodies monitoring|Monitoring anti-HLA donor-specific antibodies in the patients serum at the time of kidney transplantation and 3, 12 and 24 months after the procedure. Blood samples from patients will be collected.
15891736|NCT03714100|Behavioral|Tai Ji Quan: Moving for Better Balance|Participants will attend one-hour Tai Ji Quan: Moving for Better Balance classes twice a week for 16-weeks. Groups of participants will gather at a local community site that has videoconferencing capabilities. The instructor will be teaching the class from a different location via a live video feed.
15891737|NCT03714087|Device|T1 before aligner|The UDEA2 finishing protocol include: Training of the clinicians, evaluation of finishing records, checklist according OGS items, using of aligner with set-up)
15891738|NCT03714087|Other|T2 after the aligner|The UDEA2 finishing protocol include: Training of the clinicians, evaluation of finishing records, checklist according OGS items, using of aligner with set-up)
15891739|NCT03714087|Other|Historic control group|
15891740|NCT03714074|Device|PEEK implant abutment|Implants will be restored with abutments made from polyetheretherketone (PEEK) abutments and a PEEK superstructure
15891741|NCT03714074|Device|Zirconia abutment|Imolants will be restored with zirconia abutments and a PEEK superstructure
15891742|NCT03714061|Other|Pain Neuroscience Education|"The PNE will be administered following Explaining Pain concepts, initially contextualizing the importance of the program, addressing concepts of neuroscience and pain, incorrect information about what is pain, how the brain responds to nociception in a variety of situations, and how an experience of danger can trigger or aggravate a state of pain, coexistence of several potential protection systems, central sensitization and how to promote behavioral change, abandoning incorrect beliefs, proposing graded activity exposure.
~In addition, participants were requested to perform a group of 7 exercises two times a week. In the day of the education session (second day), participants were again oriented on how to perform the exercises and invited to show the way they were executing them at home. In the first session, participants were trained on how to perform the abdominal bracing and oriented to repeat the maneuver in all exercises during the following three weeks."
15891743|NCT03714061|Other|Self-Management Education|"Concepts about pain, musculoskeletal pain, chronic pain and disability will be addressed. Participants will be guided on the process of chronic pain, associated suffering, conceptual model of fear-avoidance and clarified on avoidant and confronting profiles. In a third phase, strategies will be presented on how to deal with chronic pain, with advice on the harmful effects of restricting activities and the use of drug therapy in a careful way (Dupeyron et al, 2011).
~In addition, participants were requested to perform a group of 7 exercises two times a week. In the day of the education session (second day), participants were again oriented on how to perform the exercises (reinforcement) and invited to show the way they were executing them at home. In the first session, participants were trained on how to perform the abdominal bracing and oriented to repeat the maneuver in all exercises during the following three weeks."
15891744|NCT03714035|Other|no intervention|no intervention
15891745|NCT03714022|Drug|Abatacept|Participants will receive abatacept at a single dose 750 mg as IV infusion.
15891746|NCT03714009|Behavioral|Fasting|"Periodic fasting last for 4weeks prior to the treatment cycle. The fasting method involves daily fasts of 14-16hours and restrict eating to an 8-10 hour eating window as 2-3 or more meals of balanced diet. Patients should take adequate water and non calorie beverages intake daily (2-3 liters)."
15891747|NCT03714009|Behavioral|No fasting|Patients will not fast . But they will take balanced food and drink 2 to 3 liters of water and non caloric drinks all the day for 4 weeks
15891748|NCT03713996|Behavioral|Cognitive behavioral therapy for insomnia|CBT-I is designed to change sleep habits as well as direct misconceptions about sleep and insomnia. Participants will receive several face-to-face interview techniques: sleep restriction therapy, stimulus control procedures, sleep hygiene, relaxation training and cognitive components. The intervention will be provided in 6-session (one session/week).
15891749|NCT03713996|Other|Health Education|Participants in this arm will receive education in sleep hygiene, foot care, causes and diagnosis of diabetes, healthy diet, and physical activity. The education will be provided in 6-session (1 session/week).
15891750|NCT03713983|Other|Observational study|Observational study
15891751|NCT03713970|Procedure|celtra duo press|celtra duo press ingot
15891752|NCT03713970|Procedure|IPS e.max press|IPS e.max press ingot
15891753|NCT03713957|Drug|GRF6021|GRF6021 for IV infusion
15891754|NCT03713957|Other|Placebo|Placebo for IV infusion
15891755|NCT03713944|Drug|Carboplatin|Carboplatin, AUC 5
15891756|NCT03713944|Drug|Pemetrexed|Pemetrexed 500mg/m2
15891757|NCT03713944|Drug|Atezolizumab|Atezolizumab 1200mg
15891758|NCT03713944|Drug|Bevacizumab|Bevacizumab 15mg/kg
15891759|NCT03713931|Diagnostic Test|PUMA Score questionnaire|"Every patient who meet the criteria for active search (older than 40 years, smokers or ex-smokers of more than 10 pack-years who attend the usual care in the first level of care) will be scored with the PUMA´s questionnaire in an application and electronic database (RedCap) specially designed for the active search of cases.
~Patients with PUMA´s score ≥ 5, and without exclusion criteria for spirometry will be referred to perform spirometry at the institution"
15891760|NCT03713918|Other|Reinforced lithium silicate endocrowns|The endodontically treated tooth will be impressed, and an endocrown restoration will be manufactured with reinforced lithium silicate and cemented with self adhesive cement
15891761|NCT03713918|Other|Post retained reinforced lith silicate crn|The endodontically treated tooth will receive a fiber post cemented with self adhesive cement and after this, the tooth will be impressed and reinforced lithium silicate crown will be cemented with self adhesive cement.
15891762|NCT03713905|Drug|GLS-010|Recombinant Human Anti-PD-1 Monoclonal Antibody
15891763|NCT03713892|Drug|CKD-504|orally administered once with investigational drug assigned on 1d morning with 240 mL of water
15891764|NCT03713892|Drug|Placebo|orally administered
15891765|NCT03713879|Device|pancreatic stenting|"a PD stent to be inserted during ERCP (a 3 to 5 cm 5Fr single pigtail pancreatic duct stent without inner flap is used, the stent is inserted after deep cannulation of pancreatic duct with a .025 or .035 wire)"
15891766|NCT03713879|Drug|Indomethacin|rectally administered indomethacin before or after ERCP
15891767|NCT03713866|Diagnostic Test|EP Imaging and Testing|"Magnetic Resonance Imaging: pre-procedure imaging is standard care prior to catheter ablation procedures for VT to document anatomy of the heart.
~120-Lead Body Surface Mapping: a 120-lead ECG will be recorded using a standardized mapping protocol. 120 disposable radiolucent silver chloride (Ag/AgCl) surface electrodes will be placed on the torso in 18 strips and connected via cables to an advanced acquisition system.
~Noninvasive programmed stimulation (NIPS) study will be performed using the patient's implanted defibrillator, and is part of standard practice during a VT catheter ablation."
15891768|NCT03713840|Behavioral|Healthy Beverages in Child Care|12-week intervention promoted consumption of healthy beverages (water, unsweetened low-fat milk) and discouraged consumption of unhealthy beverages (juice, sugar-sweetened beverages, high-fat or sweetened milk). The multi-pronged intervention was delivered via child care centers, targeted children, parents, and child care staff, and included education, environmental changes, and policies.
15891769|NCT03713827|Device|tooth restoration|restoration of non carious cervical lesions with two different restorative materials
15891770|NCT03713814|Other|Exercise|"8-week exercise program, three times a week, during 45 minutes each section. Exercises for strength, endurance and mobility of the spine using pilates´ball and mat.
~The researcher will explain, demonstrate and supervise the participants. It will start with 10 minutes of warming-up using a ergometer bicycle, followed by the mat exercises. Some of these will require motor control with mobility, others will require isometry, or concentric and eccentric phases with progression of eccentric phase timing."
15891771|NCT03713801|Drug|Metformin|Total daily dose titrated up to 1500 mg po q day over the course of 3 weeks and continued for a total exposure of 12 weeks.
15891772|NCT03713801|Drug|Placebo|Placebo tablets titrated up to 3 tablets over the course of 3 weeks and then continued as 3 daily for a total exposure of 12 weeks
15891773|NCT03713788|Other|Cold pressor test|Participants placed their non-dominant hand into cold water for 2 minutes
15891774|NCT03713775|Other|Meal Replacement Weight Loss Programme|The study intervention will be the referral to a commercial provider (CP) offering a Meal Replacement Programme. Briefly, participants will be referred to a nominated CP local counsellor who will set regular appointments during a period of 32-to-36 weeks to provide behavioural support, weight monitoring, and deliver formula meals. All counselors delivering the programme will receive, beyond their routine training and accreditation, specific information related to this study before being allocated patients.
15891775|NCT03713775|Other|Usual Care|Participants randomised to the control group will receive best usual care, consisting of a one-off face-to-face consultation on weight loss with a nurse at baseline (~15 min), together with supporting written information.
15891776|NCT03713762|Drug|peribulbar block 1 lidocaine/bupivacaine|Peribulbar block: 100 mg of lidocaine 5% and 15 mg of bupivacaine 0.5% for a total volume of the anesthetic mixture of 5 ml.
15891777|NCT03713762|Drug|peribulbar block 2 lidocaine/bupivacaine/fentanyl|Peribulbar block: 100 mg of lidocaine 5%, 15 mg of 0.5% bupivacaine and 50 mcg of fentanyl citrate for a total volume of the anesthetic mixture of 6 ml.
15891778|NCT03713749|Device|Robot esophagectomy (RE)|Patients in RE group will receive Robotic-assisted surgery in thoracic phase.
15891779|NCT03713736|Diagnostic Test|Cervical smear|Cervical smear will be obtained using an Ayre spatula and a cervical brush (Cervex-Brush®). HPV test will be performed using the CLART® HPV2 kit (Genomica).This kit enables the detection of 35 genotypes: HPV6, 11, 16, 18, 26, 31, 33, 35, 39, 40, 42, 43,44, 45, 51, 52, 53, 54, 56, 58, 59, 61, 62, 66, 68, 70, 71, 72, 73, 81, 82, 83, 84, 85 et 89.
15891780|NCT03713736|Diagnostic Test|Pregnancy test|Urinary pregnancy test
15891781|NCT03713736|Behavioral|Sexual activity questionnary|Sexual activity questionnary
15891782|NCT03713723|Device|NICaS bioimpedance system|NICaS is a bioimpedance system focusing on noninvasive assessment and monitoring of cardiovascular, respiratory, and fluid parameters.Cardiovascular monitoring will be carried out using non-invasive NICAS cardiac impedance cardiography by the use of two electrodes stickers which are pasted on the wrists for 6 minutes
15891783|NCT03713710|Behavioral|Pap testing|Women will be approached in the community by a Peer Health Educator and scheduled an appointment for a Pap testing at the local health department
15891784|NCT03713710|Behavioral|Choice|Women will be approached in the community by a Peer Health Educator and they will be given a choice between scheduling an appointment for a Pap testing at the local health department or engage in self-sampling for HPV testing at home
15891785|NCT03713697|Behavioral|Pap testing|Un/underscreened women received a home visit by a Community Health Worker and were scheduled an appointment for a Pap testing at the Basic Health Unit
15891786|NCT03713697|Behavioral|Self-collection for HPV testing|Un/underscreened women received a home visit by a Community Health Worker and were given a kit to self-collect their own sampling for HPV testing at home
15891787|NCT03713697|Behavioral|Choice|Un/underscreened women received a home visit by a Community Health Worker and were given a choice between scheduling an appointment for a Pap testing at the Basic Health Unit or self-collect their own sampling for HPV testing at home
15891788|NCT03713684|Drug|Efpeglenatide SAR439977|Pharmaceutical form: solution for injection Route of administration: subcutaneous
15891789|NCT03713684|Drug|Placebo|Pharmaceutical form: solution for injection Route of administration: subcutaneous
15891790|NCT03713684|Drug|Insulin glargine|Pharmaceutical form: solution for injection Route of administration: subcutaneous
15891792|NCT03713658|Drug|Risperidone 3 mg|Participants will receive 3 mg oral risperidone tablets once daily for up to one Week.
15891793|NCT03713658|Drug|Paliperidone Palmitate 50 mg eq.|Participants will receive 50 mg eq. PP1M intramuscular injection for 17 Weeks.
15891794|NCT03713658|Drug|Paliperidone Palmitate 75 mg eq.|Participants will receive 75 mg eq. PP1M intramuscular injection for 17 Weeks.
15891795|NCT03713658|Drug|Paliperidone Palmitate 100 mg eq.|Participants will receive 100 mg eq. PP1M intramuscular injection for 17 Weeks.
15891796|NCT03713658|Drug|Paliperidone Palmitate 150 mg eq.|Participants will receive 150 mg eq. PP1M intramuscular injection for 17 Weeks.
15891797|NCT03713658|Drug|Paliperidone Palmitate 175 mg eq.|Participants will receive 175 mg eq. PP3M intramuscular injection for 24 Weeks.
15891798|NCT03713658|Drug|Paliperidone Palmitate 263 mg eq.|Participants will receive 263 mg eq. PP3M intramuscular injection for 24 Weeks.
15891799|NCT03713658|Drug|Paliperidone Palmitate 350 mg eq.|Participants will receive 350 mg eq. PP3M intramuscular injection for 24 Weeks.
15891800|NCT03713658|Drug|Paliperidone Palmitate 525 mg eq.|Participants will receive 525 mg eq. PP3M intramuscular injection for 24 Weeks.
15891801|NCT03713645|Drug|Tacrolimus Extended Release Oral Tablet [Envarsus] 0.13mg/kg/day initiated within post-operative day 3 after kidney transplant|Study drug (tacrolimus extended-release) initiated at 0.13/mg/kg/day for all patients
15891804|NCT03713619|Drug|secukinumab|Secukinumab 300mg every 2 or every 4 weeks
15891805|NCT03713619|Drug|Placebo|Placebo 300mg every 2 or every 4 weeks
15891806|NCT03713606|Procedure|HVPG measurement|HVPG obtained by means of catheterization of a hepatic vein with a balloon catheter.
15891807|NCT03713593|Drug|lenvatinib|Administered orally once a day during each 21-day cycle
15891808|NCT03713593|Biological|pembrolizumab|Administered as an IV infusion on Day 1 Q3W
15891809|NCT03713593|Drug|saline placebo|Administered as an IV infusion on Day 1 Q3W
15891810|NCT03713580|Drug|Venetoclax|"Adding Venetoclax, a BCL-2 inhibitor, to standard high dose therapy prior to autologous stem cell transplant (ASCT).
~Venetoclax is a novel, orally bioavailable, small-molecule B-cell lymphoma-2 (Bcl-2) family inhibitor."
15891811|NCT03713567|Behavioral|Experimentally induced plaque|Experimentally induced plaque by suspension of oral hygiene only in the tested areas (tooth / implant), protected by a personalized stent made of plastic, according to the experimental gingivitis and mucositis model of 21 days of duration
15891812|NCT03713554|Procedure|FNIRS Observational|In addition to completing an Informed Consent and survey questions, fNIRS Imaging and Electroencephalography (EEG) will take place will take place:The fNIRS imaging is experimental technology that has not been approved by the FDA. EEG is a noninvasive way to record electrical activity of the brain. The recording device is made up of electrodes that are fixed to a snug-fitting elastic cap. An MRI and EEG will follow the fNIRS procedure. The MRI will be performed before participants undergo fNIRS or EEG. The MRI will be done to show there are no lesions in the inner ear and therefore is a recruitment clearance tool.
15891813|NCT03713541|Other|No intervention|Survey during normal supply.
15891814|NCT03713528|Drug|Intraoperative Intraosseous Vancomycin|After debridement and irrigation the interventional group will receive intraosseous vancomycin 500mg in 150ml of normal saline. This solution will be prepared by the hospital pharmacy and administered via an EZ-IO intraosseous cannula. 75ccs of the vancomycin solution will be injected as a bolus. Subsequent to this the remaining 75ccs will be placed in the distal femur just proximal to the femoral component evenly split between the medial and lateral femoral condyles in knees.
15891815|NCT03713515|Behavioral|ALTA|The study will involve each site starting with the usual care phase, followed by a period of 6 months during which practice facilitators will conduct the pre-implementation evaluation (e.g., workflow analysis, environmental scan), refine the practice facilitation strategies that will be used in the implementation phase, and train staff in the Advancing Medication Adherence for Latinos with Hypertension through a Team-based Care Approach (ALTA) intervention model. ALTA is an efficacious systems-level intervention designed to help patients improve their ability to take their high blood pressure medications and control their blood pressure. Practices and the Project ALTA team will work together to implement the ALTA model into routine care to improve blood pressure control and medication adherence in Latinx patients.
15891816|NCT03713489|Procedure|platelet|Participants in platelet transfusion group will receive one unit of apheresis platelets transfusion 3 times for the first week after enrollment, then 2 times a week in the following three weeks.
15891817|NCT03713476|Other|Motor task specific training|Motor training targeted to goals that are relevant to the functional needs of the patient
15891818|NCT03713463|Other|Oral Nutritional Supplement (ONS)|Per standard of care (SOC)
15891819|NCT03713450|Device|Control with imaging guidance|"Prospective randomized study during aorto-iliac revascularisation comparing patient and staff radiation exposure using the automated overlay imaging guidance, in addition to the application of the ALARA principles.
~The study includes only the per-operative period but no follow-up. The study will be performed in all imaging environment (Hybrid room or mobile)."
15891820|NCT03713450|Device|Control without imaging guidance|"Prospective randomized study during aorto-iliac revascularisation comparing patient and staff radiation exposure not using the automated overlay imaging guidance, in addition to the application of the ALARA principles.
~The study includes only the per-operative period but no follow-up. The study will be performed in all imaging environment (Hybrid room or mobile)."
15891821|NCT03713437|Diagnostic Test|Measurement of differentially methylated insulin DNA|A serum sample will be drawn to measure differentially methylated insulin DNA.
15891822|NCT03713424|Drug|Clavulanic Acid|Beta lactamase inhibitor for smoking cessation
15891823|NCT03713424|Drug|Placebo oral capsule|placebo
15891824|NCT03713411|Procedure|urethral catheter placement|urethral catheter placement to provide low-pressure urinary bladder by providing active drainage of the bladder
15891859|NCT03713086|Biological|Rabies mRNA vaccine CV7202 Dose level 1|1 or 2 doses administered IM at Days 1 and 29 in the deltoid region of the arm
15891860|NCT03713086|Biological|Rabies mRNA vaccine CV7202 Dose level 2|1 or 2 doses administered IM at Days 1 and 29 in the deltoid region of the arm
15891826|NCT03713372|Drug|Anti-EGFR monoclonal antibody|Initially, 6.0mg/kg of SCT200 will be administered once a week for a maximum of 6 cycles. After 6 cycles, 8.0mg/kg of SCT200 will be administered every two weeks until disease progression.
15891827|NCT03713359|Biological|Trial arm (MRVAC)|Volunteers from 1-45 years old will be injected only one dose of MRVAC vaccine
15891828|NCT03713359|Biological|Control arm|Volunteers from 1-45 years old will be injected only one dose of MRVAC vaccine
15891829|NCT03713346|Other|Lactose free milk|Single dose of lactose free milk
15891830|NCT03713346|Other|Jersey milk|Single dose of jersey milk
15891831|NCT03713346|Other|High A1 β-casein milk|Single dose of high A1 β-casein milk (commercial milk)
15891832|NCT03713346|Other|High A2 β-casein milk|Single dose of A2 β-casein milk
15891833|NCT03713333|Diagnostic Test|Digital Health Device Diagnostics|"Technology-enabled visitations with digital health will include the following devices used at the time of a patient-physician encounter. These findings will be available to the treating physician at the time the visitation and to be used for clinical decisions.
~Handheld imaging - focused echocardiographic examination (Butterfly IQ)
~Smartphone iECG for cardiac rhythm assessments (Alivecor)
~Blood Pressure (CloudDX)
~Oxygen Saturation (CloudDX)
~Weight (CloudDX)
~Point-of-Care Genetic Testing (Phosphorous)"
15891834|NCT03713320|Drug|Cobomarsen|At least weekly doses of cobomarsen (282 mg) throughout study treatment period
15891835|NCT03713320|Drug|Vorinostat|Daily doses of vorinostat throughout study treatment period
15891839|NCT03713268|Device|Microscope integrated optical coherence tomography|This is translational study in which subjects will either be imaged with a microscope integrated optical coherence tomography (MIOCT) system or they will use MIOCT during surgical procedures. OCT systems are optical imaging technology that allow non-contact imaging of the microanatomy of the retina, cornea, optic nerve head and retinal blood vessels. The MIOCT has been integrated into the surgical microscope used in retinal and anterior segment surgeries so it does not touch the eye. Unlike visible light from many examination devices, the infrared OCT beam is barely visible to the human eye as it sweeps across the retina. Thus the patient is not disturbed by the light.
15891840|NCT03713255|Procedure|PVB group|Patients in this group will receive preoperative ultrasound-guided thoracic paravertebral block using ropivacaine 0.5% with epinephrine 2.5 mcg/mL, and supplemental standardized anesthetic/analgesic regimen (Acetaminophen / NSAIDs / opioids for breakthrough pain).
15891841|NCT03713255|Procedure|MTP block group|Patients in this group will receive preoperative ultrasound-guided mid-point transverse process to pleura block using ropivacaine 0.5% with epinephrine 2.5 mcg/mL, and supplemental standardized anesthetic/analgesic regimen (Acetaminophen / NSAIDs / opioids for breakthrough pain).
15891842|NCT03713255|Procedure|Control Group|Patients in this group will receive preoperative ultrasound-guided sham block with subcutaneous local anesthetic injection using lidocaine 1%, and supplemental standardized anesthetic/analgesic regimen (Acetaminophen / NSAIDs / opioids for breakthrough pain).
15891843|NCT03713242|Drug|ACT-541468 25 mg|Administered as a tablet.
15891844|NCT03713242|Drug|ACT-541468 25 mg (or 10 mg depending on interim results)|Administered as a tablet.
15891845|NCT03713229|Diagnostic Test|Screening for anal squamous intraepithelial lesions|digital-anorectal exam, liquid-based cytology, human papillomavirus testing, high-resolution anoscopy
15891846|NCT03713216|Drug|Naldebain|150 mg Nalbuphine sebacate
15891847|NCT03713216|Drug|Morphine|Morphine
15891848|NCT03713203|Device|pagetex PDT|2 to 4 sessions of PDT treatment during 2.5 hours after application of Metvixia and incubation under occlusive coat.
15891849|NCT03713190|Combination Product|Empagliflozin|Sodium-glucose co-transporter 2 (SGLT2), a low-affinity, high-capacity member of an increasingly numerous family of co-transporters, is highly expressed in the proximal renal tubule, and account for the majority of the reabsorption of filtered glucose.
15891850|NCT03713190|Drug|Placebo|A substance without specific pharmacology principles
15891851|NCT03713164|Dietary Supplement|Pomegranate Juice|Volunteers will consume either one dose of pomegranate juice or pure ellagic acid, an ellagitannin naturally present in pomegranates.
15891852|NCT03713164|Dietary Supplement|Ellagic Acid|Volunteers will consume either one dose of pomegranate juice or pure ellagic acid, an ellagitannin naturally present in pomegranates.
15891853|NCT03713151|Other|Dividat FIT|The study intervention is a blended therapy approach of face-to-face physiotherapy sessions with an interactive tablet-based home exercise program.
15891854|NCT03713138|Dietary Supplement|flaxseed powder|Three different quantities of flax seed powder were intervened to the subjects. One group was given 15 grams of flax seed a day. Second group was given 20 grams and third group was given 25 grams off lax seed a day.
15891855|NCT03713125|Behavioral|Reading Tutoring|20 hours of 1:1 reading tutoring intervention over 6 weeks
15891856|NCT03713112|Other|Weekly MDT deprescribing rounds for certain drugs|"Weekly deprescribing round (from randomization to day of discharge)
~Conducted by a multidisciplinary team (non-ward doctors, pharmacist, ward nurse)
~Using the 5 steps of de-prescribing
~De-prescribing targets:
~Beer's list of potentially inappropriate medications (American Geriatric Society 2015 version)
~Supplements of questionable benefits (glucosamine, chondroitin, vitamin B complex and multivitamins)
~Symptomatic medications (laxatives, gastro-protectives, painkillers, anti-emetics and steroid creams) (Standardized verbal script to initiate de-prescribing by the team)
~On top of usual care"
15891857|NCT03713099|Device|Microwave ablation|Microwave ablations will be performed under general anesthesia via a transbronchial approach by an interventional pulmonologist or thoracic surgeon. Prior to the ablation, the treating physician will perform an endobronchial ultrasound (EBUS) to confirm disease staging.
15891858|NCT03713086|Biological|Rabipur®|3 doses administered IM at Days 1, 8 and 29 in the deltoid region of the arm
15891861|NCT03713086|Biological|Rabies mRNA vaccine CV7202 Dose level 3|1 or 2 doses administered IM at Days 1 and 29 in the deltoid region of the arm
15891862|NCT03713073|Device|Allogenic amnion chorion membrane|Allogenic amnion chorion membrane (ACM) is a minimally manipulated allograft amnion chorion tissue for use as a wound covering in dental surgery.
15891863|NCT03713073|Device|Collagen dressing|Collagen dressing is used to cover wounds in dental surgery.
15891864|NCT03713060|Diagnostic Test|Mixed meal test|All women will have mixed meal test, continous glucose monitoring and antenatal ultrasounds performed. The children born of these women will have DXA-scans performed after birth.
15891865|NCT03713034|Other|HTC game|"The research staff will orient the participants to the use of either the active or the control videogames. Players in both groups will play through an online tutorial demonstrating the mechanics of the game.
~Each player will use a dedicated device to access their game on the web and a set of headphones that they will use during each gameplay session."
15891866|NCT03713034|Other|Control game|"The research staff will orient the participants to the use of either the active or the control videogames. Players in both groups will play through an online tutorial demonstrating the mechanics of the game.
~Each player will use a dedicated device to access their game on the web and a set of headphones that they will use during each gameplay session."
15891867|NCT03713021|Device|TraceIT Tissue Marker|The maximum injection volume of TraceIT hydrogel, for a single location, is 1mL.
15891868|NCT03713008|Diagnostic Test|Fluid bolus|All patients included in the study will receive 5 ml/kg fluid bolus of a balanced crystalloid solution.
15891869|NCT03712995|Procedure|'Cutler-Beard modified with graft'|A tarsoconjunctival graft was harvested from the contralateral upper eyelid, with an extra 3 mm of conjunctiva from the superior edge of tarsus and was attached to the upper eyelid defect, differently than previously described.
15891874|NCT03712969|Drug|Shenlingcao Oral Liquid|Patients receive Shenlingcao oral liquid combined with conventional adjuvant chemotherapy, which take 4 courses, 30 days per course, one bottle per day.
15891875|NCT03712956|Drug|Caelyx®|Caelyx® every two weeks for 8 courses
15891878|NCT03712930|Drug|Pamiparib|60 mg orally twice daily (BID)
15891879|NCT03712917|Procedure|Greater Occipital Nerve Block|An enjection to paralyze the occipital nerve.
15891880|NCT03712917|Drug|Topiramate|An antiepileptic agent used for migraine prophylaxis.
15891881|NCT03712917|Drug|Flunarizine|A calcium overload blocker agent used for migraine prophylaxis.
15891882|NCT03712904|Radiation|Stereotactic Body Radiation Therapy|Undergo radiation
15891883|NCT03712904|Biological|Ziv-Aflibercept|Given IV
15891884|NCT03712891|Dietary Supplement|Coffee|Patients will receive coffee in a Styrofoam cup at a temperature of 125 degree Fahrenheit or less. Coffee will be offered to the patient in the PACU once the patient's gag reflex has been restored following their procedure. Volume of estimated coffee consumption will be measured using a sample scale (with a maximum of 300mL of coffee offered)
15891885|NCT03712878|Radiation|Total-Body Irradiation|Undergo TBI
15891886|NCT03712878|Procedure|Donor Lymphocyte Infusion|Given IV
15891887|NCT03712878|Drug|Cyclophosphamide|Given IV
15891888|NCT03712878|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo HSCT
15891889|NCT03712878|Drug|Tacrolimus|Given IV
15891890|NCT03712878|Drug|Mycophenolate Mofetil|Given IV
15891891|NCT03712852|Procedure|PRF+CAF treated patients|Patients will be treated by coronally advanced flap with addition of PRF membrane
15891892|NCT03712852|Procedure|SCTG+ CAF treated patients|Patients will be treated by coronally advanced flap with addition of SCTG graft
15891893|NCT03712852|Procedure|CAF treated patients|Patients will be treated by coronally advanced flap
15891894|NCT03712839|Other|Cognitive-functional evaluation|The participants will be evaluated with a set of tools within the context of meaningful ADL.
15891895|NCT03712826|Drug|Anti-TNF Drug|Crohn patient with antiTNF treatment
15891896|NCT03712826|Drug|Ustekinumab|Crohn disease with ustekinumab treatment
15891897|NCT03712813|Device|Macrodyne LivMD plate|Synchronous (applied to both feet) low intensity vibration for 10 minutes, twice daily for 12 months.
15891898|NCT03712800|Other|Rhythmical massage|Rhythmical Massage according to Dr Ita Wegman, derived from Swedish Massage in the 1920s. Applied for various indications in the context of Anthroposophic Medicine, aiming at a recovery of self-regulation and self-healing forces.
15891899|NCT03712800|Behavioral|HRV biofeedback|One of various biofeedback types, HRV biofeedback gives a visual feedback of the participant's heart rate variability as an indicator for general health, physical and cognitive performance, self-regulation and a decreased risk of illness.
15891900|NCT03712787|Drug|ABBV-8E12|ABBV-8E12 solution for IV infusion
15891901|NCT03712774|Other|EORTC QLQ C30|standardized questionaire
15891902|NCT03712774|Other|EORTC QLQ OES-18|standardized questionaire
15891903|NCT03712774|Other|EORTC OG-25|standardized questionaire
15891904|NCT03712761|Dietary Supplement|Enriched Protein®|This product contains high quality bovine milk proteins enriched with additional leucine.
15891905|NCT03712748|Behavioral|Imaginal Exposure therapy|All participants will complete the same arm, which is four sessions of imaginal exposure across a one month time period. Each session is separated by 1 week.
15905133|NCT03609814|Drug|Clofarabine|Given IV
15891906|NCT03712735|Drug|Bupivacaine 0.08% - fentanyl 2mcg|In each arm, bupivacaine and fentanyl are being delivered at different intervals and rates for the maintenance of labor analgesia.
15891907|NCT03712722|Other|Faecal microbiota transplantation (FMT)|FMT delivered by colonoscopy, nasojejunal tube, glycerol-based capsules, or freeze-dried encapsulated donor faeces
15891908|NCT03712709|Diagnostic Test|Truenat MTB|The Truenat MTB (including both MTB and MTB Plus) and the MTB-RIF Dx reflex assays (Molbio Diagnostics; Bangalore, India) utilize chip-based real-time micro-PCR for detection of tuberculosis (TB) and rifampicin (RIF) resistance from DNA extracted (on a separate device) from sputum samples. The Truenat MTB assay targets a single copy gene while the MTB Plus assay combines detection of a single copy and multi-copy gene.
15891909|NCT03712696|Device|DIGNICAP™|Scalp cooling to prevent chemotherapy-induced alopecia
15891910|NCT03712683|Drug|Thyroxine|Thyroxine was prescribed with the diagnosis of SCH and continued when pregnancy was confirmed
15891911|NCT03712670|Drug|Aflibercept|monthly intravitreal injections
15891912|NCT03712670|Drug|Pranoprofen|0.1% pranoprofen 3 times a day topical eye drops administration
15891913|NCT03712670|Dietary Supplement|Carotenoids|daily supplementation of nutraceutical tablets containing the AREDS2 formulation
15891914|NCT03712657|Combination Product|ERAS|"preoperative pain control;
~avoiding application of ureter;
~avoiding application of gastric tube;
~avoiding application of irrigation;
~avoiding application of drainage;
~early exercising postoperatively;
~early oral feeding postoperatively;
~early discharging."
15891915|NCT03712644|Device|FFR-guided coronary revascularization|Stenoses in range of 50-90% diameter stenosis in major coronary arteries will be assessed by FFR, and revascularized if FFR equal to or lower than 0.80. Lesions above 90% diameter stenosis in will be revascularized without further assessment.
15891916|NCT03712631|Procedure|tunneling technique bone augmentation|horizontal ridge augmentation using mixture of xenograft,autogenous bone
15891917|NCT03712618|Other|Platelet Transfusion - LONG Platelet Transfusion|Platelets Transfused over 4-HOURS
15891918|NCT03712618|Other|Platelet Transfusion - SHORT Platelet Transfusion|Platelets Transfused within 60-minutes
15891922|NCT03712592|Other|Pre and post running evaluations|"Each visit will include a series of neuromuscular, cardiovascular, blood glucose and body composition evaluations will be performed. The subjects will provide some information about their muscular pain and their food and water intake.
~Finally, for the study of sleep that only concerns participants in the 4x40 km race, a home sleep registration banner will be given to each participant of the event step by step at the arrival of each stage in order to study sleep the next night as well as 2 nights after the arrival of the last stage."
15891923|NCT03712579|Dietary Supplement|SFA-Rich Meal|Saturated fatty acid-rich test meal, containing 75g test fat
15891924|NCT03712579|Dietary Supplement|MUFA-Rich Meal|Monounsaturated fatty acid-rich test meal, containing 75g test fat
15891925|NCT03712553|Behavioral|Opt-Out|Opt-In messaging prompts participants to contact their primary care provider to receive Hepatitis C screening whereas Opt-Out messaging includes a signed laboratory order for Hepatitis C screening.
15891926|NCT03712553|Behavioral|Letter|Participants receive messaging prompting them to contact their primary care provider to receive Hepatitis C screening, either as a letter or an electronic message on the MyPennMedicine patient portal.
15891927|NCT03712553|Behavioral|Behavioral Economic Messaging|Participants receive standard messaging about HCV and ways to get screened and messaging that incorporates behavioral economic principles such as norms, reciprocity, anticipated regret, and pre-commitment to get screening.
15891928|NCT03712553|Behavioral|Usual Care Messaging|Participants receive standard messaging about HCV and ways to get screening.
15891929|NCT03712540|Drug|BMS-986278|Oral administration 30 mg
15891930|NCT03712540|Drug|Rifampin|Oral administration 600 mg
15891931|NCT03712527|Other|Injection of Platelet rich plasma|The blood of the PRP patients group will be centrifuged by the nurse using the dedicated device. A single centrifugation is required to separate the red and white blood platelets and plasma. This method of centrifugation is carried out using specific kits (Mini-GPS System III, Zimmer Biomet Company). The PRP is then collected by the nurse into a syringe that will be provided to the injector physician. Duration of preparation: 20 to 25 minutes. After a standardized sterile preparation, a local anaesthesia will be performed. Then, the injector will inject a volume of 2 mL of PRP into the median portion of the suspected disc under radiographic guidance.
15891932|NCT03712527|Other|Injection of NaCl|The placebo will be a single-dose of saline solution which corresponds to NaCl 0,9% ProAmp 10 ml (Laboratoire Aguettant). The vials will be kept at room temperature (≤ 25°C) within the local pharmacy of each centre. 2 mL of this solution will be intra-discal injected.
15891933|NCT03712514|Other|Destabilization of the upper cervical spine by Cervistab|Simulate a situation of destabilization of the cervical spine with Cervistab
15891934|NCT03712501|Behavioral|Exercise|A 60 minute walk at 60% maximal oxygen uptake.
15891935|NCT03712488|Device|flowcytometry|four colour flowcytometry
15891936|NCT03712475|Drug|Pregabalin|pharmacokinetic study under fasting conditions
15891937|NCT03712462|Behavioral|Acceptance-Based Behavioral Weight Loss Therapy for BED|ABBT group therapy incorporates standard behavioral and acceptance-based strategies and was adapted to meet suit the unique needs of BED.
15891938|NCT03712462|Behavioral|Standard Behavior Therapy|SBT group therapy will be adapted from the gold-standard standard behavioral therapy manuals used from previous weight loss studies.
15891939|NCT03712449|Device|JUVÉDERM®|Facial filler injection (JUVÉDERM VOLBELLA with Lidocaine, and/or JUVÉDERM VOLIFT with Lidocaine, and/or JUVÉDERM VOLUMA with Lidocaine, and/or JUVÉDERM VOLITE with Lidocaine) from Month 6 to Month 8 (BELKYRA Treatment) and Month 0 to Month 2 (Non-BELKYRA Treatment).
15891940|NCT03712449|Drug|BOTOX Cosmetic®|BOTOX Cosmetic, 20 U to glabellar lines and/or 2-6 U injected bilaterally to crow's feet lines and/or 24 U injected to forehead lines at Month 9 and Month 10 (BELKYRA Treatment) and at Month 3 and Month 4 (Non-BELKYRA Treatment).
15891941|NCT03712449|Drug|BELKYRA®|BELKYRA, subcutaneous injection for maximum of 6 treatments, 1 month apart from Month 0 to Month 5. Maximum dose = 100 mg (10mL).
15905134|NCT03609814|Drug|Fludarabine Injection|Given IV
15891942|NCT03712449|Other|SkinMedica|SkinMedica products (Facial Cleanser, TNS Essential Serum®, Rejuvenative Moisturizer, Optional: Total Defense + Repair Broad Spectrum Sunscreen SPF34), applied daily from Month 6 to Month 11 (BELKYRA Treatment) and Month 0 to Month 5 (Non-BELKYRA Treatment).
15891943|NCT03712436|Combination Product|Palliative care|The Palliative Care Package is a protocol for Palliative Care delivery, derived from the African Palliative Care Association and adapted to the local environment in Addis Ababa.
15891944|NCT03712436|Combination Product|Standard oncological care|Standard Oncological Care available in Addis Ababa, Ethiopia which includes chemotherapy, radiation oncology
15891945|NCT03712423|Drug|Cripec Docetaxel|89 Zirconium Cripec Docetaxel PET
15891946|NCT03712410|Behavioral|PISCES|The intervention is based on Problem Solving Therapy and is a coping skills intervention designed for family caregivers of hospice patients.
15891947|NCT03712397|Drug|nanoliposomal irinotecan|combination therapy of nal-IRI , leucovorin and 5-FU in sequence at day 1, every 14 days counted as one cycle
15891948|NCT03712384|Other|Semi structured face to face interview|Face-to-face semi-structured interview conducted in the hospital, where young adults were hospitalized 10 years before, in a quiet and isolated office. The topic guide was built according to literature review, without further change after pilot test. Interviews where audio-recorded and transcribed
15891949|NCT03712371|Drug|Chitosan|The starting dose for Chitosan is 500mg twice a day, the second dose level is 1000mg twice a day, the third dose level is 1500mg twice a day, and the fourth dose level is 2000mg twice a day. Each dose level lasts for 28 days.
15891950|NCT03712358|Biological|PVSRIPO|Intralesional injection of PVSRIPO.
15891951|NCT03712345|Drug|IFX-1|Single IV infusions of IFX-1
15891952|NCT03712345|Drug|IFX-1|Single IV infusions of IFX-1
15891953|NCT03712345|Drug|Placebo|Placebo
15891954|NCT03712332|Behavioral|Distress Tolerance Group|The intervention is a distress tolerance skills-based group informed by mindfulness and acceptance principles and dialectical behavioural therapy (DBT).
15891955|NCT03712319|Behavioral|REM Volver a casa|The program aims to train the ability of the mind to focus attention on the present moment without judging, accepting the experience. REM is an application available for Android and iOs. It proposes a guided training through 8 stages. They contain video recordings with explanations about the fundamentals of mindfulness, audio recordings that guide practices of mindfulness, as well as suggestions to bring it into everyday life. They can be used whenever it suits the user. The app counts the progress of each participant, as well as the mood changes according to a distress scale before and after performing a formal practice. The app has been designed following the international recommendations for the development of apps (MARS guide).
15891956|NCT03712319|Behavioral|Mindfulness-Based Stress Reduction program|The program aims to train the ability of the mind to focus attention on the present moment without judging, accepting the experience. MBSR is a program developed at the University of Massachusetts Medical Center in the 1970s by Professor Jon Kabat-Zinn. MBSR uses a combination of mindfulness meditation, body awareness, and yoga to help people become more mindful. In recent years, meditation has been the subject of clinical research, that suggests it may have beneficial effects, including stress reduction, relaxation, and improvements to quality of life. While MBSR has its roots in spiritual teachings, the program itself is secular. The session is delivered to a small group of people by a certified instructor during two and a half hours, every week.
15891957|NCT03712306|Other|Dietary advice|Dietary advice to increase protein intake to at least 1.2 g/kg adjusted body weight/d
15891958|NCT03712306|Other|Dietary advice and advice on timing|Dietary advice to increase protein intake to at least 1.2 g/kg adjusted body weight/d plus advice on consuming protein in close proximity of usual physical activity
15891959|NCT03712293|Device|BBB Disruption with Chemotherapy Arm|The ExAblate BBB disruption of targets associated with enhancing post-resection MRI imaging procedure will be performed with ExAblate 4000 type 2.0 system and will coincide with on one of three first days of each planned TMZ adjuvant therapy cycle as one procedure per cycle.
15891960|NCT03712280|Drug|MNK6106|1 gram tablet of MNK6106 for oral administration
15891961|NCT03712280|Drug|Rifaximin|550 mg tablet of rifaximin for oral administration
15891964|NCT03712254|Drug|Fosphenytoin|Patients with trigeminal neuralgia that due to acute exacerbations of trigeminal neuralgia pain are admitted for fosphenytoin loading are the subjects of interest.
15891965|NCT03712241|Drug|K-285|Topical
15891966|NCT03712241|Drug|Indomethacin|Capsule
15891967|NCT03712228|Biological|Factor XIIa antagonist monoclonal antibody|Factor XIIa antagonist monoclonal antibody for intravenous and subcutaneous use
15891968|NCT03712228|Drug|Placebo|Buffer without active ingredient
15891969|NCT03712215|Other|Rehabilitation|diaphragmatic electrical stimulation
15891970|NCT03712202|Drug|Bleomycin|Given IV
15891971|NCT03712202|Drug|Brentuximab Vedotin|Given IV
15891972|NCT03712202|Drug|Dacarbazine|Given IV
15891973|NCT03712202|Drug|Doxorubicin|Given IV
15891974|NCT03712202|Biological|Nivolumab|Given IV
15891975|NCT03712202|Other|Quality-of-Life Assessment|Ancillary studies
15891976|NCT03712202|Drug|Vinblastine|Given IV
15891977|NCT03712189|Device|LifeFlow|The LifeFlow® is a hand-operated rapid infuser designed to administer fluids to patients by a single user, for clinical situations in which a large volume or rapid infusion of fluid or colloid is required. The device delivers fluid in 10mL increments with each complete handle compression, which refills during release, automating a push-pull mechanism. The syringe then automatically refills with handle release.
15892036|NCT03711799|Behavioral|Access to services via peer coaching|This intervention will allow for half of the participants, randomly selected, to get help navigating the system of acquiring services for their child. These participants will be assisted by a coach who are also parents of a child with autism and have already been through the process.
15892104|NCT03711240|Drug|Irinotecan|150mg/m2 1.5-hour iv infusion, day 1 every 2 weeks
15891978|NCT03712176|Behavioral|Lifestyle alteration|Patients will receive self-report questionnaires to evaluate their quality of life, fatigue level, anxiety and depression, cognitive complaint, cognitive efficiency, nutritional quality and food preferences, and sedentary behavior. Patients will also do tests to determine their physical conditions : six-minute walk test (6MWT), 30-s chair-stand test. The intervention will be done at three stages of the patient's care pathway: 1 / before the adjuvant surgery (baseline), 2 / at 6 months after the surgery and chemotherapy 3 / at 7 months after radiotherapy treatment.
15891979|NCT03712163|Drug|Norketotifen Oral Capsule (Cohort 1)|Single dose Norketotifen
15891980|NCT03712163|Drug|Norketotifen Oral Capsule (Cohort 2)|Single dose Norketotifen
15891981|NCT03712163|Drug|Norketotifen Oral Capsule (Cohort 3)|Single dose Norketotifen
15891982|NCT03712163|Drug|Norketotifen Oral Capsule (Multiple Dose Cohort)|Multiple dose Norketotifen
15891983|NCT03712163|Drug|Placebo Oral Capsule|Placebo
15891984|NCT03712150|Device|tdcs|application of optimised parameters of tDCS (anodal stimulation, 1.5 mA, 10 min) over the unconditioned hemisphere reverses the brain and behavioural consequences of inhibitory pre-conditioning
15891985|NCT03712137|Device|VOLUX XC|Participants will be treated with VOLUX XC hyaluronic acid (HA) injectable gel on day 1 with an optional maintenance treatment at Month 12.
15891986|NCT03712137|Other|No-treatment control|No-treatment during the control period. Optional delayed-treatment with VOLUX XC (initial with optional touch-up) during the Post-Control period.
15891987|NCT03712124|Drug|CNSA-001|CNSA-001 Powder for Suspension
15891988|NCT03712124|Drug|Placebos|Placebo Suspension
15891989|NCT03712111|Drug|Norepinephrine 6 mcg|An intravenous bolus of norepinephrine 6 mcg will be administered for management of maternal hypotension.
15891990|NCT03712111|Drug|Norepinephrine 10 mcg|An intravenous bolus of norepinephrine 10 mcg will be administered for management of maternal hypotension.
15891991|NCT03712111|Drug|Bupivacaine Hydrochloride|Subarachnoid block will be performed using Bupivacaine hydrochloride (2.2 mL) in addition to fentanyl 25 mcg
15891992|NCT03712111|Drug|Norepinephrine infusion|Prophylactic norepinephrine infusion will be started after subarachnoid block
15891993|NCT03712098|Drug|Liraglutide|Liraglutide 3.0 mg is an injectable medicine that may help some adults with excess weight (BMI ≥27) who also have weight-related medical problems or obesity (BMI ≥30) lose weight and keep the weight off. Liraglutide is approved by the U.S. Food and Drug Administration (FDA) for chronic weight management when combined with a reduced-calorie meal plan and physical activity.
15891994|NCT03712098|Drug|Placebo|The placebo is an inactive substance that is designed to look like liraglutide but contains no medication.
15891995|NCT03712098|Behavioral|Smoking Cessation Counseling|All participants receive manual-based counseling from a trained smoking cessation counselor. The counseling sessions are designed to enhance awareness of the harmful effects of smoking, assist the participant in developing skills to quit, and avoid relapse.
15891996|NCT03712085|Other|Abdominal acupuncture|Abdominal acupuncture treatment method: 1.Acupoints selection :Zhongwan,Xiawan,Shangqu,Qihai,Guanyuan,Huaroumen,Upper rheumatic and Upper rheumatic external points etc.(Acupoints selection referred to Abdominal Acupuncture Therapy written by Bo Zhiyun ,the founder of Abdominal Acupuncture. 2.Treatment Duration: 30 minutes a session, once a day, 5 times a week for 3 weeks.
15891997|NCT03712085|Other|Sham abdominal acupuncture|Sham abdominal acupuncture Abdominal acupuncture treatment method: 1.Acupoints selection and treatment duration are the same as abdominal acupuncture. 3.Method：Using the sham abdominal acupuncture needles were produced by DONGBANG AcuPrime Acupuncture Instrument Co., Ltd. ( U.K.)The tip of the needle was exposed to 1mm of the cannula. The acupoint skin of patients was touched gently by the tip, and the tip of needle was lifted and removed from acupoint skin after 30s. Rest for 30 seconds ,then repeated 6 times, a total time of stimulation is 6min.
15891998|NCT03712072|Device|Magnetoencephalography (MEG)|The purpose of the device is to measure magnetic fields produced by an individual's brain and provide information on the location of the source of the fields. Participants between the ages of 0-3 years of old whose head can fit in the MEG helmet will be the patient population used for the BabyMEG. The device will be used in this study to learn more about the somatosensory and motor networks of children who have cerebral palsy and compare their brain signals to healthy children.
15891999|NCT03712072|Device|Electroencephalography (EEG)|The device is an EEG cap - a non-invasive EEG positioning system used to quickly place a large number of surface electrodes in a quick and consistent manner on the head. The device will measure electrophysiological signals from the scalp.
15892000|NCT03712072|Device|Transcranial Magnetic Stimulation (TMS)|The device will be used for motor mapping. Motor threshold is operationally defined as minimum machine output necessary to elicit a response from the abductor pollicis brevis right (APB), contralateral to the stimulated hemisphere, of 50 microvolts, on >50% of trials. Upper limb motor mapping is conducted at 110% abductor pollicis brevis motor threshold in each hemisphere, or at 100% machine output (MO). Lower limb motor mapping is conducted at a fixed machine output corresponding to the magnitude sufficient to elicit reliable tibialis anterior (TA) motor evoked potentials (MEPs). Single pulse TMS is performed while motor evoked potentials are recorded bilaterally from the APB, deltoid, and TA using surface electromyography (EMG).
15892001|NCT03712059|Diagnostic Test|FIT test and colonoscopy|All included patients received FIT test and then colonoscopy, with the risk factors of CRC recorded. The diagnostic performance of predicting model (based on FIT and risk factors) and colonoscopy were compared.
15892002|NCT03712059|Diagnostic Test|Polypectomy and biopsy|All included patients received polypectomy, and then biopsy is performed on the edge of resection for patients with < 10 mm adenoma (confirmed by pathology or predicted by NBI images), with the complete resection rate of polyps being calculated.
15892003|NCT03712059|Diagnostic Test|Classification|Pathology of polyps is classified by endoscopists through NICE principle and the performance of classification between endoscopists and computer is compared.
15892004|NCT03712046|Diagnostic Test|18F-FDG PET-CT|Patient will receive one injection of 18F-FDG and then undergo PET-CT imaging
15892037|NCT03711786|Other|Basic implementation package|The basic implementation package will involve identifying an internal coordinator who is one of the full-time on-site providers at the clinic. The internal coordinator provides mentoring to peers and support to leadership in implementing the treatment program and aligning it with clinic priorities.
15892105|NCT03711240|Drug|Leucovorin|200mg/m2 2-hour iv infusion, day 1 every 2 weeks
15892005|NCT03712007|Device|MAMP therapy with MARPE expander|Twenty patients will be submitted to MAMP therapy with MARPE expander as anchorage in the maxillary arch. The appliance anchorage will be provided by bands adapted on the maxillary first permanent molars and circumferential clamps in the maxillary canines or premolars. The maxillary and mandibular miniscrews will be placed in the same section. After a 24-hour period, parents will be oriented to activate the expander screw. Patients will be instructed to wear intermaxillary elastics connecting the maxillary first molar hooks to the mandibular mini-implants.
15892006|NCT03712007|Device|MAMP therapy with Hyrax expander|Fifteen patients will be submitted to MAMP therapy with Hyrax expander as anchorage in the maxillary arch. The appliance anchorage will be provided by bands adapted on the maxillary first permanent molars and circumferential clamps in the maxillary canines or premolars. The mandibular miniscrews will be placed and after a 24-hour period, parents will be oriented to activate the expander screw. Patients will be instructed to wear intermaxillary elastics connecting the maxillary first molar hooks and the mandibular mini-implants.
15892007|NCT03711994|Other|Alkantis|cold therapy pack placed on the wound post operatively
15892008|NCT03711981|Procedure|TAP Block|
15892009|NCT03711968|Other|Rehabilitative treatment protocol|A combination of: postural exercise with visual spatial tasks, relaxation, balance exercise, motricity improvement and cognitive rehabilitation.
15892010|NCT03711955|Other|Exercise|Two types of training exercises, AET and IRT, will be used as the interventions in this study. Participants will either be assigned to the AET group or the IRT group, where they will participate in the respective training intervention group for 8 consecutive weeks.
15892011|NCT03711942|Procedure|Intra orifice barrier|After primary root canal treatment, Glass Ionomer Cement (KetacTM Molar, 3M ESPE) applied as intraorifice barrier 3mm inside canal from root canal orifice in first group, as 2mm base on floor of pulp chamber in second group and direct composite restoration in 3rd group without Intraorifice barrier or base.3mm GP in the orifice was removed and intraorifice barrier and 2mm thick base was given of GIC.
15892012|NCT03711942|Procedure|Base|After primary root canal treatment, Glass Ionomer Cement (KetacTM Molar, 3M ESPE) applied as intraorifice barrier 3mm inside canal from root canal orifice in first group, as 2mm base on floor of pulp chamber in second group and direct composite restoration in 3rd group without Intraorifice barrier or base.2mm thick Base of GIC was applied over the orifice before composite restoration
15892013|NCT03711942|Procedure|Control|After primary root canal treatment, Glass Ionomer Cement (KetacTM Molar, 3M ESPE) applied as intraorifice barrier 3mm inside canal from root canal orifice in first group, as 2mm base on floor of pulp chamber in second group and direct composite restoration in 3rd group without Intraorifice barrier or base.coronal accees upto orifice was restored with composite resin
15892014|NCT03711929|Drug|DE-109 Intravitreal Injections|440 ug of DE-109 Injectable Solution
15892015|NCT03711929|Other|Sham Procedure|The sham procedure mimics an intravitreal injection without penetrating the eye.
15892016|NCT03711929|Drug|DE-109 Intravitreal Injections|Undisclosed Fixed Dose of DE-109 Injectable Solution (range of 44 ug to 880 ug)
15892017|NCT03711916|Device|PlasmaBlade 3.0S|PlasmaBlade (Medtronic) is approved by United States Food and Drug Administration (FDA) as a low thermal dissection device that has shown to be associated with effective cutting, and significantly lower temperature than traditional electrosurgical dissection devices.
15892018|NCT03711903|Drug|Acetyl-Valine-Serine-Arginine-Arginine-Arginine-NH2 (Ac-VSRRR- NH2).|The study drug, CN-105 is supplied in amber glass vials containing 4 mL of a concentrated 12.5-mg/mL clear-to-slightly-yellow solution.
15892019|NCT03711903|Drug|0.9% Sodium-chloride|normal saline
15892020|NCT03711890|Procedure|Optical Coherence Tomography|Undergo OCT
15892021|NCT03711890|Procedure|Therapeutic Conventional Surgery|Undergo resection will be undertaken
15892022|NCT03711890|Diagnostic Test|Laboratory Evaluation|Labs will be obtained to test for cancer cell derived exosomes
15892023|NCT03711877|Device|Scalp cooling system|Scalp cooling was initiated 30 minutes prior to each chemotherapy cycle, with scalp temperature maintained at 3°C (37°F) throughout chemotherapy and for 90 minutes to 120 minutes afterward. Temperature of scalp cooling system can be controlled constantly, the effect of reducing scalp temperature maybe better and patient tolerance maybe better. Meanwhile, there is a higher likelihood of hair retention due to a tight fit in scalp cooling system.
15892024|NCT03711877|Device|Cold cap|The operation of chemical cold cap is convenient and the price was low, and the economic burden of patients was not increased. But it is necessary to replace the cold cap periodically during chemotherapy, and the temperature during chemotherapy is difficult to keep constant.
15892025|NCT03711864|Biological|IM21 CAR-T cells|fludarabine and cyclophosphamide Two days before cell infusion,all patients will be treated with fludarabine and cyclophosphamide for 3 days
15892026|NCT03711851|Behavioral|Self-help Acceptance and commitment therapy (Web-based)|9 week program with minimal contact with therapist (predominantly self-help)
15892027|NCT03711851|Behavioral|Self-help Acceptance and commitment therapy (bibliotherapy)|9 week program with contact with therapist (predominantly self-help)
15892028|NCT03711851|Other|Self-help Education pamphlets on pain (active control group)|9 week program with contact with therapist (predominantly self-help)
15892029|NCT03711838|Dietary Supplement|N-Acetylcysteine|N-Acetylcysteine in a powder form diluted in a 250 ml drink containing 248 ml water and 2 ml of natural, non-caloric, flavoring-sweetener containing sucralose.
15892030|NCT03711838|Dietary Supplement|Placebo|Placebo consisted of 248 ml water and 2 ml of natural, non-caloric, flavoring-sweetener containing sucralose.
15892031|NCT03711825|Drug|LYN-057|Administration of single dose of LYN-057 presented as extended release capsule containing 50 mg of memantine hydrochloride (HCl)
15892032|NCT03711825|Procedure|Imaging Assessment (MRI)|Imaging assessments [MRI] will be performed on specified days according to protocol
15892033|NCT03711825|Procedure|Imaging Assessment (U/S)|Imaging assessments (abdominal U/S) will be performed on specified days according to protocol
15892034|NCT03711812|Procedure|Serratus Anterior Plane Catheter|Insertion of a Serratus Anterior Plane Catheter to establish a continuous analgesic block with a local anaesthetic infusion
15892035|NCT03711812|Procedure|Thoracic Epidural Catheter|Insertion of a Thoracic Epidural Catheter to establish a continuous analgesic block with a local anaesthetic infusion
15892068|NCT03711474|Drug|Saline|Single dose of Dexamethasone IV or Saline IV given within the first hour of surgey
15892038|NCT03711786|Other|Enhanced implementation package|The enhanced implementation package will combine the internal coordinator with an external quality assurance committee. This committee will complete quarterly audits at the facility to evaluate compliance with the depression treatment protocol as well as providing high-level support in implementing the treatment program through clinical expertise and limited on-site presence.
15892039|NCT03711773|Other|Group Physical Therapy Classes|Three times weekly, these subjects will have one hour group physical therapy sessions with either a physical therapist, physical therapy assistant, or personal trainer. These sessions will be aimed to improve strength and function in a low-impact setting designed specifically for those with joint pain.
15892040|NCT03711760|Behavioral|telepsychology|CBT delivered by telepsychology
15892042|NCT03711734|Other|Acupuncture + Standard of Care|Acupuncture is a nonpharmacologic pain management modality that has been shown to provide superior analgesia for acute pain. This will be combined with our facility's standard of care anesthesia and pain management plan.
15892043|NCT03711721|Dietary Supplement|Food basket|
15892044|NCT03711721|Dietary Supplement|Ready-to-Use Therapeutic Food|
15892045|NCT03711708|Drug|Zoloft Oral Solution|Test Product: 50 mg sertraline administered as 2.5 mL of Zoloft Oral Solution (20 mg/mL) after dilution with 120 mL of water
15892046|NCT03711708|Drug|Zoloft tablets|Reference Product: 50 mg sertraline administered as 1x Zoloft 50 mg tablet
15892047|NCT03711695|Device|iBeat wristwatch device|The participant will be asked to wear one iBeat wristwatch device on each arm during the planned procedure.
15892048|NCT03711682|Dietary Supplement|Cinnamon|Participants in this group will receive cinnamon capsules for 12 weeks period. With a 2 g dose in capsules with 500 mg of cinnamon powder (Cinnamomum verum), 1 g in during the breakfast (2 capsules) and the other 1 g (2 capsules) during the dinner.
15892049|NCT03711682|Dietary Supplement|Wheat Flour|Participants in this group will receive placebo capsules for 12 weeks period. With a 2 g dose in capsules with 500 mg of wheat flour(fortified with iron, niacin, thiamin, riboflavin and folic acid), 1 g in during the breakfast (2 capsules) and the other 1 g (2 capsules) during the dinner.
15892050|NCT03711669|Behavioral|Immunosuppression withdrawal|IS will be tapered gradually over a period of 6 months. Azathioprine will be stopped during the first 3 months, reducing the dose 50% every month. Prednisone will be tapered 2.5mg monthly until total withdrawal. During withdrawal and the first year after stopping treatment patients will undergo laboratory tests on a monthly basis, afterwards follow-up will be done every 3 months until the end of the project.
15892051|NCT03711656|Device|isCGM (intermittently scanned Continuous Glucose Monitoring)|Data collection
15892052|NCT03711656|Device|Physical exercise tracker|Data collection
15892053|NCT03711643|Procedure|Periprostatic nerve block|4 injections of 2 cc of lidocaine for a Periprostatic nerve block
15892054|NCT03711643|Device|hypnosis mask|"The mask HYPNOS pro stimulates the imagination of the user by means of 6 diodes among 3 by eye.
~Just before the introduction of ultrasound probe, the patient put the hypnotic mask and choose a session.Twenty minutes after the removal of the probe, an healthworker assess the painful patient with the visual analogue scale VAS, after this the patient fulfill the STATE- TRAIT Anxiety Inventory (STAI) form Y-A."
15892055|NCT03711630|Behavioral|Meditation|Meditation practice will be through the InsightTimer smart device application. Participants will choose what types of meditation practices they will engage in and report their time spent meditating via REDCap.
15892056|NCT03711604|Drug|Tenalisib|BID Orally
15892057|NCT03711591|Device|Conventus Cage PH device|The Conventus CAGE™ PH (PH Cage) is a permanent implant comprised of an expandable scaffold, made from nitinol and titanium, which is deployed into the medullary canal and provides a structure to which fractured bone fragments are attached using fragment screws.
15892058|NCT03711578|Drug|Tenalisib,|BID, Orally
15892059|NCT03711565|Device|Regular Nasal CPAP using a conventional ventilator|The Nasal CPAP is connected to the patient via prongs in the nose. Pressure adjustments are made to improve lung inflation. The frequency and pressure can be adjusted as needed to improve the patient's oxygen and carbon dioxide levels
15892060|NCT03711565|Device|High Frequency Nasal CPAP|High Frequency Nasal CPAP for management of respiratory distress Patient will be connected to the high frequency device through nasal prongs. The Bronchotron produces a pressure that is variable with an adjustable frequency that is equal or greater than 500 times per minute connecting to prongs in the patient's nose. The pressure, frequency and amplitude of the pulsations will be adjusted as needed to provide acceptable oxygenation and ventilation.
15892061|NCT03711552|Other|ObsQoR-11|Quality of recovery questionnaire
15892062|NCT03711552|Other|QoR-15|Quality of recovery questionnaire
15892063|NCT03711513|Behavioral|Cognitive behavioral therapy|All conditions start with a psycho-education session (PE). Subsequently, participants in condition A follow four exposure sessions (EX). Participants in condition B follow two cognitive restructuring (CR) followed by two exposure sessions. Participants in condition C follow two relaxation exercises sessions (RE) followed by two exposure sessions. All sessions will take place at their school in a group of five to eight adolescents (week 9,10,11,12,13,14). The sessions will be provided by a psychologist who receives training and supervision by a certified CBT therapist. The psychologist is assisted by a master student in psychology.
15892064|NCT03711500|Drug|D-serine|Subjects will receive three sessions of auditory remediation paired with either D-serine or Placebo in a 4:1 D-serine:placebo ratio. This will be conducted in 3 separate cohorts of D-serine dose 80, 100 and 120 mg/kg, which 15 subjects per cohort (12 active and 3 placebo) per cohort
15892065|NCT03711500|Drug|Placebo|Subjects will receive three sessions of auditory remediation paired with either D-serine or Placebo in a 4:1 D-serine:placebo ratio. This will be conducted in 3 separate cohorts of D-serine dose 80, 100 and 120 mg/kg, which 15 subjects per cohort (12 active and 3 placebo) per cohort
15892066|NCT03711487|Drug|Foeniculum Vulgare Seed Ironing|Stir-fry 500 grams of Foeniculum vulgare seeds until the aroma overflows. Put them into a cotton bag. Ironing therapy put the bag on abdomen after the temperature is suitable, 30 minutes per time, twice daily on postoperative days 2 to 3. The medicine bag can be heated and reused after it cool down.
15892067|NCT03711474|Drug|Dexamethasone|Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
15892102|NCT03711240|Drug|bevacizumab|5mg/kg iv day 1 every 2 weeks
15892069|NCT03711461|Device|endotracheal tube (double lumen)|patients routinely use double lumen endotracheal intubation while they have received thoracoscopy
15892070|NCT03711461|Device|nonintubated|patients receiving nonintubated anesthetic plan while they have received thoracoscopy
15892071|NCT03711448|Drug|prednisone treatment|tapering prednisone regimen
15892072|NCT03711448|Drug|prednisone and ustekinumab treatment|Treatment with prednisone and ustekinumab (90 mg subcutaneously at inclusion (W0), W4, W16 and W28)
15892073|NCT03711448|Other|questionnaires|HAQ ; SF-36 ; FACIT-fatigue
15892074|NCT03711448|Biological|Blood samples|Additional blood samples for immunomonitoring
15892075|NCT03711435|Diagnostic Test|Metabolomics|we test the two group with metabolomics for serum，the case group with TCM Syndrome，and other diagnostic tests
15892076|NCT03711435|Drug|Traditional Chinese Medicine Formulation|Traditional Chinese Medicine Formulation was used in IPF patients to identify the effects between different TCM types of IPF patients
15892077|NCT03711422|Drug|Afatinib|40mg daily
15892078|NCT03711422|Drug|Afatinib|160mg for 3 days every 3 weeks
15892079|NCT03711409|Other|Soft tissue biased manual therapy group|It includes hot pack and muscle release technique of pectoralis major, pectoralis minor, teres major, teres minor, infraspinatus and posterior deltoid muscles. Subjects are supine on the bed. The muscle release technique is applied at the end available range and the acceptable intensity. The time of muscle release intervention is about 30 min and hot-pack about 15 min.
15892080|NCT03711409|Other|Conventional physical therapy group|It includes modality (electrotherapy, ultrasound and low-level laser therapy) and GH joint mobilization. GH joint mobilization includes anterior to posterior glide, caudal glide and distraction. The intensity of joint mobilization is grade III to IV. The time of joint mobilization is about 30 min and hot-pack for 15 min.
15892081|NCT03711396|Behavioral|Advance Care Planning Group Visit|"Aim 1: The first part of this study will focus on refining and adapting the Advance Care Planning Group Visit intervention so that it meets the needs of persons with amnestic cognitive impairment and a study partner who participates with them.
~Aim 2: The second part of the study will pilot test the Advance Care Planning Group Visit intervention adaptations, called ENgaging in Advance Care planning Talks Group Visit intervention (ENACT Memory Group Visits), to see if it is feasible, acceptable and improves the number of people with amnestic mild cognitive impairment who complete an advance directive (a legal form that describes someone's wishes for future medical care if they are unable to make their own decisions). It will also see how ready individuals are to participate in advance care planning. The overall goal is to improve opportunities for older adults with amnestic mild cognitive impairment to receive medical care that is consistent with their values, goals, and preferences."
15892082|NCT03711383|Dietary Supplement|Inulin and Resistant Starch|12g per inulin in combination 7.5 g resistant starch per day the day before the CID Resistant starch 7.5 g
15892083|NCT03711383|Dietary Supplement|Inulin|12g per inulin in combination with maltodextrin per day the day before the CID
15892084|NCT03711383|Dietary Supplement|Placebo|isocaloric maltodextrin before test day
15892085|NCT03711370|Other|Clear Bottle|These mothers will receive usual care from their pediatric providers and each mother will be given 12 conventional, clear bottles of various sizes (4-12 ounces) that are compatible with a variety of different nipples manufactured by leading bottle companies. Mothers will also be given a handout about paced bottle-feeding, which includes messages about feeding in response to infant cues.
15892086|NCT03711370|Other|Opaque Bottle|These mothers will receive everything provided to the clear group, but will instead receive 12 opaque, weighted bottles of various sizes (4-12 ounces). These bottles will be stainless steel and compatible with a variety of different nipples manufactured by leading bottle companies. Mothers in the intervention group will also receive a handout about how opaque bottles can help them attend to infant cues.
15892087|NCT03711357|Radiation|980 nm diode laser|980 nm high power diode laser device.
15892088|NCT03711357|Other|placebo|the diode laser fiber optic tip will be inserted in root canals, but will not be activated.
15892089|NCT03711344|Behavioral|Cognitive Behavioral Therapy|The intervention will be administered by therapists working at community agencies who are experienced at providing Cognitive Behavioral Therapy.
15892090|NCT03711331|Other|FilmArray® Pneumonia panel plus|Early adjustment of antimicrobial therapy according to the results of the Unyvero® testing for patients suspected with VAP or HAP requiring MV.
15892091|NCT03711331|Other|Standard care|Standard care, with broad-spectrum antimicrobial therapy unchanged until reception of traditional microbiology results
15892092|NCT03711318|Drug|Buprenorphine/naloxone|3 week treatment with buprenorphine/naloxone
15892093|NCT03711305|Drug|SHR-1316|SHR-1316 intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6) and maintenance phase.
15892094|NCT03711305|Drug|Carboplatin|Carboplatin intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).
15892095|NCT03711305|Drug|Etoposide|Etoposide intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6).
15892096|NCT03711305|Drug|Placebo|Placebo intravenous infusion will be administered during the induction phase (Cycles 1-4 or 6) and maintenance phase.
15892097|NCT03711292|Behavioral|Antibiotic Stewardship|For the 12-month intervention period, in a stepped-wedge fashion, sites will be exposed to a site-adapted multifaceted stewardship intervention consistent with CDC core elements for outpatient antimicrobial stewardship: commitment, action, monitoring, reporting and education, and also included a behavioral component that used individualized audit and feedback, peer comparison, and public commitment, in addition to standard patient and clinician education on antibiotic prescribing for antibiotic nonresponsive ARIs.
15892098|NCT03711279|Drug|SHR-1210 Plus Apatinib|SHR-1210 (200mg lyophilized powder in a single-dose vial for reconstitution) q3w+ Apatinib (250mg/375mg tablets) qd
15892099|NCT03711279|Drug|ADM Plus IFO or IFO Alone|ADM 60mg/m2 D1 + IFO 2mg/m2 D1-D4 q3w；if the cumulative doses of ADM is beyond 450mg/m2, the monotherapy of IFO (2mg/m2 D1-D5 q3w) will be used.
15892100|NCT03711266|Behavioral|PE-PC|PE-PC treatment will follow the PE-PC manual and patient workbook. Treatment content for PE-PC is drawn from the PE model and condensed so as to deliver the most efficacious components of PE. PE-PC consists of four, 30-minute appointments scheduled approximately once a week over 4-6 weeks
15892101|NCT03711253|Drug|Bictegravir 50mg+Tenofovir AF 25 mg+emtricitabine 200 mg|antiretroviral therapy
15892106|NCT03711240|Drug|5-FU|2400mg/m2 46-hour continuous iv infusion, day 1 every 2 weeks
15892107|NCT03711227|Diagnostic Test|Procalcitonin lab test|A procalcitonin order bundle will be created for admitted patients with pneumonia. This prepopulated bundle includes an initial and 24 hour procalcitonin level.
15892108|NCT03711214|Procedure|Periodontal scaling|Periodontal scaling and root planing
15892109|NCT03711201|Behavioral|Group IORE|This group will undergo the IORE procedure before surgery (operation). On the day of surgery, the patient will be brought to the operating room by the anesthesiologist. Hemodynamic data (blood pressure, pulse rate, respiratory rate, SpO2) will be measured at the service, preop unit and operating room. The anxiety level in the operating room will be measured by the ST-STAI scale.
15892110|NCT03711188|Drug|Nivolumab|Nivolumab is to be administered as a 3 mg/kg IV infusion every two weeks in accordance with the prescribing information.
15892111|NCT03711188|Drug|Ipilimumab|Ipilimumab, when used as subsequent treatment for patients in cohort B, is to be administered as a 3 mg/kg IV infusion over 90 minutes every three weeks for a maximum of 4 doses, in accordance with the prescribing information.
15892112|NCT03711188|Drug|IMM-101|A single 0.1 mL intradermal injection of IMM 101 (10 mg/mL) given every 2 weeks for the first 3 doses followed by a rest period of 4 weeks, then one dose every 2 weeks for the next 3 doses. This is followed by a dose every 4 weeks thereafter.
15892113|NCT03711175|Procedure|Subscapularis repair|Utilizing fiberwire, high tensile strength suture
15892114|NCT03711175|Device|Shoulder implant|Reverse shoulder arthroplasty device
15892115|NCT03711162|Drug|GLPG1690|GLPG1690, film-coated tablets for oral use.
15892116|NCT03711162|Drug|Placebo|Matching placebo, film-coated tablets for oral use.
15892117|NCT03711149|Other|Activity monitor feedback loop|The intervention arm will test if the feedback system (i.e., activity monitor, real-time feedback, and art tours) increases daily step count, decreases length of stay, and improves patient and provider communication, patient awareness of step count goals, and patient confidence in accomplishment of daily goals.
15892118|NCT03711136|Procedure|aortic prosthesis|ascending aortic and/or aortic arch prosthesis with linear vascular prosthesis or hybrid prosthesis
15892119|NCT03711123|Behavioral|Group metacognitive therapy|10 weekly Group session of 90 minutes duration
15892120|NCT03711123|Behavioral|Clinical management|10 weekly individual sessions With clinical management including guided self-help
15892121|NCT03711110|Other|Intensive cardiovascular monitoring|"Schedule of visits: Evaluation before starting chemotherapy, at three and six months and annually for five years (eight visits: baseline, 3rd and 6th month, 1st, 2nd, 3rd, 4th and 5th years).
~Assessment protocol: Anamnesis and physical examination; EKG; Echocardiogram; Biomarkers (troponin and natriuretic peptide); Structured counselling on healthy cardiac practices; Treatment optimization of cardiovascular risk factors and heart diseases; Quality of life (ECOG Performance status and Minnesota questionnaires); Interaction and management of patient care by the cardio-onco-hematology team. Moreover, cardiac MRI in centers participating in the CARTIER-MR sub-study."
15892122|NCT03711110|Other|No intervention|"Schedule of visits: Evaluation before starting chemotherapy, at three and six months and annually for five years (eight visits: baseline, 3rd and 6th month, 1st, 2nd, 3rd, 4th and 5th years).
~Assessment protocol: Anamnesis and physical examination; ECOG Performance status; cardiac patient care based on the onco-hematologist criteria"
15892123|NCT03711097|Drug|Vanish XT Dental Varnish|Varnish will be applied to the front surface of the intervention upper central and lateral incisors
15892124|NCT03711084|Dietary Supplement|Natural high potency sweetener from leaf extract|"Upon arrival, participant's blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will rate their feelings of hunger, fullness etc using VAS at 0, 15, 30 and 60 min.
~Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks designed to capture behaviour in response to food cue presentation. Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full."
15892125|NCT03711084|Dietary Supplement|Glucose|"Upon arrival, participant's blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will rate their feelings of hunger, fullness etc using VAS at 0, 15, 30 and 60 min.
~Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks designed to capture behaviour in response to food cue presentation. Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full."
15892126|NCT03711084|Dietary Supplement|Sucrose|"Upon arrival, participant's blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will rate their feelings of hunger, fullness etc using VAS at 0, 15, 30 and 60 min.
~Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks designed to capture behaviour in response to food cue presentation. Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full."
15892127|NCT03711084|Dietary Supplement|Maltodextrin|"Upon arrival, participant's blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will rate their feelings of hunger, fullness etc using VAS at 0, 15, 30 and 60 min.
~Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks designed to capture behaviour in response to food cue presentation. Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full."
15892128|NCT03711084|Dietary Supplement|Water|"Upon arrival, participant's blood will be collected at 0 (before the consumption of the test beverage), 15, 30 and 60 min after the consumption of the drink. Participants will rate their feelings of hunger, fullness etc using VAS at 0, 15, 30 and 60 min.
~Fifteen min after the consumption of the drink, participants will complete a set of computer-based tasks designed to capture behaviour in response to food cue presentation. Thirty min after the consumption of the drink, a lunch buffet will be served and participants will be free to eat as much or as little as they like until feeling comfortably full."
15892129|NCT03711071|Other|"Workshop ICE training"|The workshop includes training in communication skills in relation to evidence based medicine.
15905579|NCT03606473|Radiation|[C-11]NPA|PET radiotracer
15892130|NCT03711058|Drug|Copanlisib|"Copanlisib will be administered as a 60 minute IV infusion (-5min/+10min) at a dose of 45 mg - 60 mg IV. Copanlisib will be administered once a week (days 1, 8, and 15 or Day 1 and Day 15 of each 28 day cycle).
~Drug: 45 or 60 mg IV"
15892131|NCT03711058|Drug|Nivolumab|"Nivolumab 480 mg will be administered as a 30 minute IV infusion (-5min/+10min) on Day 1 of each 28 day cycle.
~Drug: 480 mg IV"
15892132|NCT03711045|Behavioral|eye-tracking|"After completing a demographics form, theBeck Depression Inventory,Beck Anxiety Inventory,Barratt Impulsiveness Scale and Ruminative Response Scale-21, each participant has to go to the eye-tracking room and seats in a height adjustable chair and places their chin in a chin rest which was positioned to make sure all participants' eye are in the same location relative to the camera and the monitor.
~There are 18 trials and 2 filler trials in the free-view task, each of which contains 4 pictures on the same screen for 25 seconds. There is also a gap screen between each trial lasting for 2 seconds when participants were asked to fixate in the center of the screen. During the experiment, participants are instructed to watch the screen as naturally as possible, and the initial location of the fixation of each trial and the total dwell time of each emotional images(negative, happy, neutral and suicide-related)and the changes of the pupil size were recorded."
15892135|NCT03711019|Device|Magnetic Seizure Therapy (MST)|"MST treatment will be administered using the MagPro MST with a Cool TwinCoil over the frontal cortex in the midline position using 100 Hz stimulation. Seizure threshold will have been determined during the first treatment session following a standard established protocol in the context of CREST-MST or CORRECT-BD. Treatment in the continuation phase will be administered at the same stimulus dose as the last treatment in acute phase.
~This will be performed under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes."
15892136|NCT03711019|Device|RUL-UB ECT|"In the RUL-UB ECT arm treatment, the MECTA spectrum 5000Q machine will be used, which is an FDA approved device used for providing standard-of-care clinical ECT treatments. Seizure threshold will have been determined during the first treatment session following a standard established protocol in the context of CREST-MST or CORRECT-BD. Treatment in the continuation phase will be administered at the same stimulus dose as the last treatment in acute phase.
~This will be performed under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes."
15892137|NCT03711019|Device|Bitemporal ECT|"Bitemporal ECT treatments will be administered using the MECTA spECTrum 5000Q, which is an FDA approved device used for providing standard-of-care clinical ECT treatments. Bitemporal ECT will be administered at 1.5 times seizure threshold according to standard clinical practice. Treatment in the continuation phase will be administered at the same stimulus dose as the last treatment in acute phase.
~This will be performed under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes."
15892138|NCT03711006|Other|Fecal Microbiota Transplantation Capsules|25 daily multi-donor FMT Capsules for 50 days
15892139|NCT03710993|Device|oximeter|Participants breathe a controlled gas mixture to induce several reduced oxygen states while oximeter measurements are taken for comparison to corresponding transfer standard and reference devices to assess oximeter calibration and accuracy.
15892140|NCT03710980|Device|Oximeter|Participants breathe a controlled gas mixture to induce several reduced oxygen states while oximeter measurements are taken for comparison to corresponding arterial blood draw samples to assess oximeter accuracy.
15892141|NCT03710967|Device|Transcranial magnetic stimulation|Transcranial magnetic stimulation of the primary motor cortex
15892142|NCT03710954|Diagnostic Test|Experimental Group|All volunteers were evaluated by numerical pain scale and Fuzzy scale. This procedure was performed to compare the efficacy of the Fuzzy Scale demonstrating greater accuracy of quantification of skeletal muscle pain
15892143|NCT03710941|Drug|REGN2477+REGN1033|Single, sequential, repeat-dose Intravenous (IV) or matching placebo
15892144|NCT03710941|Drug|Matching placebo|Single, sequential, repeat-dose Intravenous (IV)
15892145|NCT03710928|Other|very low carbohydrate diet|"All meals will be delivered and participants will consume study foods exclusively. Participants will receive a fiber supplement as needed with each meal to support digestive health, and a daily multi-vitamin, magnesium and omega-three supplement to ascertain micronutrient sufficiency. Participants will be weighed at each study visit and the diet plan will be adjusted for satiety and weight-maintenance.
~The diet composition will be as follows: 5% carbohydrate, 70% fat, 20% protein."
15892146|NCT03710928|Other|standard carbohydrate diet|"All meals will be delivered and participants will consume study foods exclusively. Participants will receive a daily multi-vitamin and omega-3 supplement to ascertain micronutrient sufficiency. Participants will be weighed at each study visit and the diet plan will be adjusted for satiety and weight-maintenance.
~The diet composition will be as follows: 50% carbohydrate, 30% fat, 20% protein."
15892147|NCT03710915|Drug|HG146|HG146 will be administered every other day for 14 days, followed by 1 week off the drug with each treatment cycle of 21-days.
15892148|NCT03710902|Diagnostic Test|ECG monitoring for 3 weeks|A 3-week continuous ECG monitoring to detect occult AF.
15892149|NCT03710902|Other|Self-monitoring of BP and self-titration of antihypertensive medication|One-week monthly self-monitoring of BP and self-titration of antihypertensive medication according to a pre-specified protocol, assisted with a mobile device application.
15892150|NCT03710889|Drug|Abaloparatide|Abaloparatide is a novel, synthetic, 34 amino acid peptide designed to be a potent and selective activator of the PTH/PTH-related protein (PTHrP) type 1 receptor (PTHR1) signaling pathway with 41% homology to PTH[1-34] and 76% homology to human PTHrP[1-34].
15892197|NCT03710590|Other|ECIG Lab Session 30 watts, 15 mg nicotine|During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
15892154|NCT03710863|Drug|CM082|Subjects will receive CM082 orally twice daily for two weeks followed by two weeks off in four-week cycles. The starting dose of 25mg BID will be increased by 100% to the maximum dose of 50mg BID.The treatment period is tentatively set at 1 year.
15892155|NCT03710850|Dietary Supplement|Inulin|Inulin is a dietary fibre. Will be supplemented in a dose 10g/d for a period of 3 moths.
15892156|NCT03710837|Other|Pain neuroscience education|Two different lectures covering essential clinical skills but one designed to explore the hypothesis
15892157|NCT03710837|Other|Red flag education|Two different lectures covering essential clinical skills but one designed to explore the hypothesis
15892158|NCT03710824|Drug|Nintedanib|diagnosed IPF patients initiating treatment with nintedanib
15892159|NCT03710811|Drug|Insulin|Continuous Subcutaneous Insulin Infusion
15892160|NCT03710798|Dietary Supplement|Low carbohydrate high fat diet|Energy balanced low carbohydrate high fat diet during 6 weeks. Then 6-week reintroduction of a healthy normal diet
15892161|NCT03710785|Behavioral|cervical spine extension exercise|cervical spine extension exercise for 4 weeks
15892162|NCT03710772|Drug|Cyclophosphamide|Given IV
15892163|NCT03710772|Drug|Cytarabine|Given IV
15892164|NCT03710772|Drug|Dexamethasone|Given PO or IV
15892165|NCT03710772|Drug|Doxorubicin Hydrochloride|Given IV
15892166|NCT03710772|Drug|Ibrutinib|Given PO
15892167|NCT03710772|Drug|Methotrexate|Given IV
15892168|NCT03710772|Biological|Rituximab|Given IV
15892169|NCT03710772|Drug|Venetoclax|Given PO
15892170|NCT03710772|Drug|Vincristine Sulfate|Given IV
15892171|NCT03710759|Other|Assistive autogenic Drainage|Assistive autogenic Drainage : All the 3 components of Autogenic drainage was given passively to the patients. By placing the hands on the child's chest, the therapist manually increases the expiratory flow to achieve the different lung volume breathing.
15892172|NCT03710746|Behavioral|Project Health|A brief dissonance-based obesity prevention program delivered in six one-hour weekly sessions.
15892173|NCT03710746|Behavioral|Response and Attention Training|Individualized, computerized response and attention training consisting of five separate tasks designed to increase inhibitory control to reduce overeating.
15892174|NCT03710733|Radiation|Sequential boost|Boost (10 Gy/4 fx/1 week) is given after whole breast irradiation
15892175|NCT03710733|Radiation|Concomitant boost|Boost (8 Gy/15 fx/3 weeks) is given with whole breast irradiation
15892176|NCT03710720|Behavioral|TIPS app|Psycho-educational electronic application
15892177|NCT03710720|Behavioral|Trauma Focused-Cognitive Behavioral Therapy|Effective form of trauma therapy for adolescents
15892178|NCT03710707|Drug|DNL201|Oral repeating dose
15892179|NCT03710707|Drug|Placebo|Oral repeating dose
15892180|NCT03710694|Device|DAV132|"DAV132:
~Dosage: 15 g/day activated charcoal (22.5 g/day DAV132)
~Route: Oral
~Duration: duration of fluoroquinolone treatment + 2 days
~DAV132 is regulated as a medical device in Europe and as a drug in the United States of America."
15892181|NCT03710681|Biological|SHR-1314|Pharmaceutical form: Injection solution. Route of administration: subcutaneous injection.
15892182|NCT03710668|Radiation|MRI if indicated|MRI brain if indicated
15892183|NCT03710655|Drug|Apitox - pure honeybee toxin|Intradermal injection of 0.01 microliters
15892184|NCT03710655|Drug|Placebo|Intradermal injection of 0.01 microliters
15892185|NCT03710642|Drug|Prazosin|Oral prazosin HCl capsules (or placebo) will be administered twice daily, with individualized doses up to a maximum of 4 mg QAM mid-morning and 6 mg at bedtime (QHS), or matching placebo capsules
15892186|NCT03710642|Drug|Placebo oral capsule|Placebo capsule matched to appearance of active drug.
15892187|NCT03710629|Other|Patients with driver genes|Patients with driver genes
15892188|NCT03710616|Procedure|Surgeries|Surgical operations plus systematic lymphadenectomies
15892189|NCT03710603|Drug|Daratumumab|Daratumumab will be given at a dose of 1800 mg SC weekly in Cycles 1 and 2, then every 2 weeks in Cycles 3-6. In maintenance Cycles 7+, subjects will receive daratumumab once every 4 weeks until disease progression or unacceptable toxicity. MRD-negative subjects will stop daratumumab after sustained MRD negativity for 12 months & after a min. of 24 months of maintenance. Daratumumab should be restarted at recurrence of MRD or confirmed loss of CR without disease progression.
15892190|NCT03710603|Drug|velcade|Bortezomib will be given at a dose of 1.3 mg/m2 SC twice a week (Days 1, 4, 8, and 11) in Cycles 1-6; four 28-day induction cycles (Cycles 1 to 4), and two 28-day consolidation cycles (Cycles 5-6). Subjects will not receive bortezomib after Cycle 6. On treatment days when both bortezomib and daratumumab are administered, bortezomib must be administered after the daratumumab administration.
15892191|NCT03710603|Drug|Lenalidomide|Lenalidomide will be administered PO at 25 mg on Days 1 to 21 in Cycles 1-6; four 28-day induction cycles and two 28-day consolidation cycles. Following consolidation, subjects will then start maintenance therapy, during which they will receive lenalidomide 10 mg daily PO on Days 1 to 28 (continuously) of each 28-day cycle until disease progression or unacceptable toxicity. After 3 cycles of maintenance therapy, if well tolerated, the lenalidomide dose may be increased to 15 mg daily, at the discretion of the investigator.
15892192|NCT03710603|Drug|dexamethasone|Dexamethasone will be administered PO at 40 mg daily on Days 1-4 and Days 9-12 of each 28-day cycle during induction and consolidation (Cycles 1-6). On daratumumab administration days, during induction/consolidation, dexamethasone may be administered intravenously 1 hour before the daratumumab administration. On days when daratumumab is not administered, dexamethasone is administered PO. Dexamethasone tablets are to be taken with or immediately after a meal or snack, preferably in the morning.
15892193|NCT03710590|Other|ECIG Lab Session 15 watts, 10 mg nicotine|During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
15892194|NCT03710590|Other|ECIG Lab Session 15 watts, 15 mg nicotine|During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.).
15892195|NCT03710590|Other|ECIG Lab Session 15 watts, 30 mg nicotine|During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
15892196|NCT03710590|Other|ECIG Lab Session 30 watts, 10 mg nicotine|During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
15907272|NCT03593291|Diagnostic Test|Anti Xa|Levels of Anti Xa measure
15892198|NCT03710590|Other|ECIG Lab Session 30 watts, 30 mg nicotine|During each session, participants will first complete a 10-puff product use bout, and then a 90-minute ad lib product use bout.
15892199|NCT03710577|Behavioral|Yoga|1 session
15892200|NCT03710577|Behavioral|Quiet Rest|1 session
15892201|NCT03710564|Biological|Brolucizumab|6 mg/0.05mL solution for intravitreal injection
15892202|NCT03710564|Biological|Aflibercept|2 mg/0.05mL solution for intravitreal injection
15892203|NCT03710551|Other|Experimental Infant Formula|Standard bovine milk-based infant formula with a new fat blend plus L. reuteri, fed ad libitum
15892204|NCT03710551|Other|Standard Infant Formula|Standard bovine milk-based infant formula, fed ad libitum
15892205|NCT03710538|Dietary Supplement|Snack beverage|Consumption of a 200ml of soy beverage (100Kcal, 11g CHO, 6g proteins, 4g fat)
15892206|NCT03710538|Behavioral|Exercise|3min walk at 60% VO2max every 30 minutes,(x5)
15892207|NCT03710525|Other|Own-Price Elasticity|The price of vegetables will be 75%, 100%, or 125% of the reference price, but the price of other foods will remain the same.
15892208|NCT03710525|Other|Cross-Price Elasticity|The price of vegetables will remain the same, but the price of other foods will be 75%, 100%, or 125% of the reference price.
15892209|NCT03710512|Procedure|Bilateral sagittal split osteotomy|Bilateral sagittal split osteotomy of the mandible is a surgical procedure used to correct dentofacial discrepancies
15892210|NCT03710499|Procedure|Physical activity|Activities included overall stretching and strengthening (flexion, extension, adduction and abduction movements) and muscular endurance exercises (exercises involving open and closed kinetic chains), along with aerobic conditioning using a functional circuit.
15892211|NCT03710473|Diagnostic Test|Optical sensor, Pulse watch|Continuous blood pressure monitoring obtained by a Pulse watch
15892212|NCT03710460|Drug|Dapagliflozin|10 mg, one per day before breakfast during 12 weeks.
15892213|NCT03710460|Drug|Dapagliflozin plus Metformin XR|10/1000 mg, one per day before breakfast during 12 weeks.
15892214|NCT03710460|Drug|Metformin XR|1000 mg, one per day before breakfast during 12 weeks.
15892215|NCT03710447|Other|HIIT + WB-EMS|"12-week supervised exercise program consisting of ergometer-based high-intensity interval training (HIIT) and whole-body electromyostimulation (WB-EMS).
~HIIT: 5x1 min at 85-95% HRmax divided by low-intensity recovery periods. WB-EMS: Simulanteous stimulation of all major muscle groups with dedicated individual intensity.
~2 exercise sessions per week. Order of application: HIIT - WB-EMS. Additionally, participants receive individualized nutritional counseling."
15892216|NCT03710447|Other|WB-EMS + HIIT|"12-week supervised exercise program consisting of whole-body electromyostimulation (WB-EMS) and ergometer-based high-intensity interval training (HIIT).
~WB-EMS: Simulanteous stimulation of all major muscle groups with dedicated individual intensity.
~HIIT: 5x1 min at 85-95% HRmax divided by low-intensity recovery periods. 2 exercise sessions per week. Order of application: WB-EMS - HIIT. Additionally, participants receive individualized nutritional counseling."
15892217|NCT03710447|Other|HIIT + CST|"12-week supervised exercise program consisting of ergometer-based high-intensity interval training (HIIT) and conventional low-volume strength training(CST).
~HIIT: 5x1 min at 85-95% HRmax divided by low-intensity recovery periods. CST: Conventional 1-set strength training using weight machines to train all major muscle groups with an individual intensity corresponding to 70-80% of one repetition maximum.
~2 exercise sessions per week. Order of application: HIIT - CST. Additionally, participants receive individualized nutritional counseling."
15892218|NCT03710447|Other|CST + HIIT|"12-week supervised exercise program consisting of conventional low-volume strength training(CST) and ergometer-based high-intensity interval training (HIIT).
~CST: Conventional 1-set strength training using weight machines to train all major muscle groups with an individual intensity corresponding to 70-80% of one repetition maximum.
~HIIT: 5x1 min at 85-95% HRmax divided by low-intensity recovery periods. 2 exercise sessions per week. Order of application: CST - HIIT. Additionally, participants receive individualized nutritional counseling."
15892219|NCT03710434|Drug|AZD4635 50 mg nano-suspension (reference)|Subjects will receive a single dose of AZD4635 50 mg nano-suspension (reference) in the fasted state.
15892220|NCT03710434|Drug|AZD4635 solid oral formulation - fasted|Subjects will receive a single dose of AZD4635 solid oral formulation, in the fasted state.
15892221|NCT03710434|Drug|AZD4635 solid oral formulation - fed|Subjects will receive a single dose of AZD4635 solid oral formulation, in the fed state.
15892222|NCT03710434|Drug|Lansoprazole and AZD4635 50 mg solid oral formulation|Subjects will receive lansoprazole 30 mg BID for 5 days followed by a single dose of AZD4635 50 mg solid oral formulation in the fasted state.
15892223|NCT03710434|Drug|AZD4635 solid oral formulation variant 1 - fasted|Subjects will receive a single dose of AZD4635 solid oral formulation, variant 1 in the fasted state.
15892224|NCT03710434|Drug|AZD4635 solid oral formulation variant 2 - fasted|Subjects will receive a single dose of AZD4635 solid oral formulation, variant 2 in the fasted state.
15892225|NCT03710434|Drug|[14C] AZD4635 IV microtracer - fasted|Subjects will receive a single dose of [14C] AZD4635 IV microtracer. This intervention will be co-administered with AZD4635 solid oral formulation variant 1.
15892226|NCT03710421|Procedure|CS1-CAR T Therapy|Undergo CS1-CAR T therapy
15892227|NCT03710421|Drug|Cyclophosphamide|Given IV
15892228|NCT03710421|Drug|Fludarabine|Given IV
15892229|NCT03710421|Procedure|Leukapheresis|Undergo leukapheresis
15892230|NCT03710408|Other|Intravenous hydration|"Participants assigned to the intravenous hydration arm will receive their hydration therapy through an intravenous access. This access will be achieved by inserting a BD VenflonTM Pro Safety - 22G in a vein in the dorsal side of the hand or further up the forearm. If the participants is suspected of becoming delirious and at risk of removing the cannula from the hand/forearm, it may be inserted at the dorsal side of the foot. The clinical staff judge this risk and decide site of placement.
~Furthermore, a sham subcutaneous access device BD Saf-T-Intima™ Integrated Safety Catheter System will be placed on the abdomen without piercing the skin."
15892270|NCT03710148|Other|Natural exposure of deficient or excessive iodine|Natural exposure of deficient iodine from diet & drinking water, and of excessive iodine intake from drinking water
15892271|NCT03710122|Drug|Vancomycin|Firvanq by Cutis Pharma
15892272|NCT03710122|Other|Placebo|Placebo for Vancomycin
15892273|NCT03710109|Other|EEG|non-invasive, non-interventional sensor
15907316|NCT03593018|Drug|Bendamustine|Bendamustine injection
15892231|NCT03710408|Other|Subcutaneous hydration|"Participants assigned to the subcutaneous hydration arm will receive their hydration therapy through a subcutaneous access. This access will be achieved by placing a BD Saf-T-Intima™ Integrated Safety Catheter System on the abdomen or, alternatively if the participants is suspected of becoming delirious and at risk of removing the needle, it will be placed on the back at the scapular region.
~Furthermore, a sham IV access device BD VenflonTM Pro Safety - 22G will be placed on the dorsal side of the hand without piercing the skin."
15892232|NCT03710395|Procedure|Blood and breast milk sampling|At least 15 days after starting treatment with 20 mg slow-release nifedipine every 12 hours. Blood and breast milk will be sampled before first dosing in the morning.
15892233|NCT03710395|Drug|Nifedipine|Chronic hypertensive breastfeeding women will be treated with slow-release 20 mg nifedipine, twice a day.
15892234|NCT03710382|Other|Walking epidural|Parturients in spontaneous or induced labor will receive combined spinal-epidural analgesia (CSE) using an infusion of bupivacaine 0.0625% and fentanyl 2 mcg/mL and will be encouraged to walk a minimum of 15 minutes every hour during the first stage of labor.
15892235|NCT03710369|Drug|Placebo|The placebo pill was compounded by McDonalds Pharmacy.
15892236|NCT03710369|Drug|Sildenafil|Sildenafil from Pfizer, compounded by McDonalds Pharmacy.
15892237|NCT03710356|Drug|Danazol 200 MG|DANAZOL 200 mg as capsules 800 mg/d orally, in 2 doses Duration of treatment: 12 months
15892238|NCT03710343|Drug|Metformin|Participants will be randomized to either the Metformin (Glucophage) or Placebo group at baseline. Participants in both groups will receive active physiotherapy twice weekly during the 16 week intervention. Participants will be followed-up until 40 weeks from baseline.
15892239|NCT03710343|Drug|Placebo Oral Tablet|Participants will be randomized to either the Metformin (Glucophage) or Placebo group at baseline. Participants in both groups will receive active physiotherapy twice weekly during the 16 week intervention. Participants will be followed-up until 40 weeks from baseline.
15892240|NCT03710330|Drug|normal saline|110 ml normal saline IV just before skin incision
15892241|NCT03710330|Drug|1gm tranexamic acid|1 gm tranexamic acid (2 ampoules of Capron 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision
15892242|NCT03710330|Drug|0.5 gm tranexamic acid|0.5 gm tranexamic acid (2 ampoules of Capron 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision
15892243|NCT03710317|Drug|carbetocin|100 μg carbetocin ampoule will be diluted in 10 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist after the birth of the baby
15892244|NCT03710317|Drug|Tranexamic Acid|1 gm tranexamic acid in 100 mL of intravenous solution infusion over 15 min.
15892245|NCT03710317|Drug|misoprostol|Group 2 400 μg buccal misoprostol (2 tablets of 200 μg) will be given after spinal anesthesia and few minutes before skin incision
15892246|NCT03710304|Drug|Oxytocin|20 IU oxytocin or placebo ampoules in 500 mL of intravenous solution infusion over 15 min after delivery of the baby.plus 2tab placebo buccal plus 110 ml saline by slow infusion
15892247|NCT03710304|Drug|Tranexamic acid plus misoprostol|1 gm TA or separate placebo will be diluted in 100 mL normal saline and administered slowly (over 30-60 s) intravenously by the anesthetist before skin incision,
15892248|NCT03710304|Drug|misoprostol|400 μg misoprostol (2 tablets of 200 μg) will be give buccally after spinal anesthesia and few minutes before skin incision;
15892249|NCT03710291|Drug|TRC101|Oral, non-absorbed, polymeric hydrochloric acid binder
15892250|NCT03710291|Drug|Placebo|Placebo comparator
15892251|NCT03710278|Device|LPat Device|Performing Lumbar Puncture utilizing LPat device
15892252|NCT03710265|Drug|SHR-1701|Subjects will receive an intravenous infusion of SHR-1701 in a dose escalation until confirmed progression, unaccepted toxicity, or any criterion for withdrawal from the study.
15892253|NCT03710252|Drug|paritaprevir/ritonavir/ombitasvir + dasabuvir +/- ribavirin|OMB/PTV/r + DSV +/- RBV
15892254|NCT03710239|Device|Dilapan-S|Synthetic osmotic dilator
15892255|NCT03710239|Device|Laminaria|Seaweed-based osmotic dilator
15892256|NCT03710213|Behavioral|Text Message-based Intervention|The intervention consists of a series of educational and reminder text messages that a patient will receive in the week prior to a scheduled colonoscopy, in addition to two text messages at the time of enrollment explaining the texting program.
15892257|NCT03710200|Other|Bologna 00+S. cerevisiae yeast|Bologna 00 bread made with yeast (portion corresponding to 50g available carbohydrates) +500 mL of water
15892258|NCT03710200|Other|Bologna 1+S. cerevisiae yeast|Bologna 1 bread made with yeast (portion corresponding to 50g available carbohydrates) +500 mL water
15892259|NCT03710200|Other|Bio2+S. cerevisiae yeast|Bio2 bread made with yeast (portion corresponding to 50g available carbohydrates) +500 mL water
15892260|NCT03710200|Other|ICARDA+S. cerevisiae yeast|Icarda bread made with yeast (portion corresponding to 50g available carbohydrates) +500 mL water
15892261|NCT03710200|Other|Bologna 1+sourdough|Bologna 1 bread made with sourdough (portion corresponding to 50g available carbohydrates) +500 mL water
15892262|NCT03710200|Other|Bio 2+sourdough|109g of Bio2 bread made with sourdough (portion corresponding to 50g available carbohydrates) +500 mL water
15892263|NCT03710200|Other|ICARDA+sourdough|Icarda bread made with sourdough (portion corresponding to 50g available carbohydrates) +500 mL water
15892264|NCT03710200|Other|Grossi+sourdough|Grossi bread made with sourdough (portion corresponding to 50g available carbohydrates) +500 mL water
15892265|NCT03710187|Drug|Hydrocortisone|Hydrocortisone 50 mg IV Q6h
15892266|NCT03710174|Radiation|Infrared LED photobiomodulation|Infrared LED (3 X 6 cm) will be administered using a board with 6 LEDs with a wavelength of wavelength: 850 nm ± 20 nm, seven-minute operation time, optical spot of 5 ± 2 mm and optical output of 2~5 mW, with a dose of 2.675 J/cm2. Further analyses will be performed immediately after the photobiomodulation session and one week later.
15892267|NCT03710174|Device|Occlusal splint|After the initial evaluation, molds will be made for the fabrication of the splints, which will be delivered one week later. Written and verbal instructions for use will be given. After one month of daily use, the volunteers will return for the final morphological and psychosocial evaluations.
15892268|NCT03710174|Radiation|Placebo LED photobiomodulation|The same procedure as LED group with the device turned off.
15892269|NCT03710161|Drug|Vitamin D|Vitamin D taken in two different dosages daily for six months.
15892373|NCT03709355|Drug|Omeprazole|Omeprazole Film-coated tablets 20mg
15892274|NCT03710096|Device|macGrath|in the mac grath group we use the videolaryngoscope macGrath as first-line for the insertion of double lumen tube
15892275|NCT03710096|Device|Macintosh's|in the macintosh group we use the laryngoscope with Macintosh's blade as first-line for the insertion of double lumen tube
15892276|NCT03710083|Device|Guardian™ Sensor (3)|Use two Guardian™ Sensor (3)s each connected to a Guardian™ Connect transmitter for approximately 7 days.
15892277|NCT03710070|Device|Amplatzer vascular plug 4|See above
15892278|NCT03710070|Other|Sham Control|Angiography of the IMA without occlusion
15892279|NCT03710057|Drug|Ivabradine|A prospective, post-marketing observational study was conducted in National Institute of cardiovascular disease, Karachi-Pakistan. Total 50 patients were advised to take 5 mg Ivabradine (SIVAB) twice daily for 8 weeks.
15892280|NCT03710044|Drug|Cyclosporine A|"Initial treatment: Oral cyclosporine A (CsA) treatment (4-5 mg/kg/day) for 3 weeks.
~Responders shift to oral low-dose CsA treatment (2-2.5 mg/kg/day) until onset of a second flare or until Week 16 (Day 113).
~In case of a second AD flare, the subjects shift back to oral high-dose CsA treatment (4-5 mg/kg/day) for 3 weeks."
15892281|NCT03710031|Other|PNS Tracking|Through blood and stool samples the study team will track the interplay among PNS as they relate to diminished QOL. Symptoms tracked include neurocognitive dysfunction, fatigue, anxiety, depression and pain, inflammation (cytokines and C-reactive protein), gut microbiota [(GM) richness and diversity] and diet (macronutrients: carbohydrates, fats and proteins).
15892282|NCT03710005|Procedure|Ascent|Dehydrated Cell and Protein Concentrate injection
15892283|NCT03710005|Procedure|Standard|Standard corticosteroid injection
15892284|NCT03709992|Drug|Trospium Chloride|30 mg of Trospium chloride tablet twice daily
15892285|NCT03709992|Drug|Tamsulosin|0.4 mg of Tamsulosin tablet once daily
15892286|NCT03709979|Device|C-MAC videolaryngoscope|An intubating device that is used for endotracheal intubation. Endotracheal intubation will be performed by anesthesiologist with C-MAC videolaryngoscope
15892287|NCT03709966|Device|Portable monitoring device|similar to a wrist-sport watch with many features including step calculations, distance traveled, calories burned, but also heart rate and sleep status
15892288|NCT03709966|Behavioral|Routine|Physical activity promotion supported by a kinesiologist
15892289|NCT03709953|Drug|Apatinib|500 mg，po，QD； 28 days every cycle
15892290|NCT03709940|Drug|MPH|Participants undergo behavioural tests and brain scanning twice, once under placebo and once under an acute dose of MPH, before starting long-term treatment with a long-acting formulation of MPH used routinely at the Adult ADHD Clinic.
15892291|NCT03709927|Drug|ZTI-01|6g IV fosfomycin
15892292|NCT03709927|Drug|Moxifloxacin 400mg|oral moxifloxacin (Avelox 400 mg) + IV normal saline (Placebo)
15892293|NCT03709927|Other|Placebo IV|IV Placebo (0.9% Normal Saline)
15892294|NCT03709914|Drug|ZTI-01 100 mg/kg|ZTI-01 intravenous (IV)
15892295|NCT03709914|Drug|ZTI-01 75 mg/kg|ZTI-01 intravenous (IV)
15892296|NCT03709901|Other|Active Allograft|Injection of viable allograft into the nucleus pulposus of the degenerated disc
15892297|NCT03709901|Other|Placebo|Injection of sterile normal saline (0.9% sodium chloride) into the nucleus pulposus of the degenerated disc
15892298|NCT03709888|Drug|Memantine XR-pregabalin combination therapy|Pregabalin and memantine XR work in different pathways and are approved by the U.S. Food and Drug Administration for various indications. Both medications have an established safety profile and have demonstrated improvement on neuropathy-related symptoms.
15892299|NCT03709875|Device|TR Treatment|A virtual reality based system, consisting of two PC-based workstations, located at the patient's home and at the rehabilitation center, will be used. For the motor treatments the patient has to move the real end effector, following the trajectory of the corresponding virtual task displayed on his computer screen. The speech (mainly lexical based) and cognitive (attention focused) exercises will be delivered from the two Research Institutes to the patient's home. During the treatment at home, the patients will use wearable monitoring devices to monitor their status (speed, heart rate, respiratory rate, training load and single-lead ECG in real-time) and to provide real-time feedback during exercises.
15892300|NCT03709862|Diagnostic Test|Whole Genome Sequencing|Residual DNA from clinical samples will be utilised for whole genome sequencing of Treponema pallidum the causative agent of syphilis
15892301|NCT03709849|Drug|experimental group: Bushen Culuan Decoction and Clomiphene Citrate Tablets placebo|the same as group description including dosage, frequency and duration
15892302|NCT03709849|Drug|control group: Clomiphene Citrate Tablets and Bushen Culuan Decoction placebo|the same as group description including dosage, frequency and duration
15892303|NCT03709823|Drug|Cytisine|film coated tablet containing 1.5 mg cytisine in a single tablet
15892304|NCT03709823|Drug|Placebo Comparator|1.5 mg cellulose powder to match final weight of the cytisine tablet
15892305|NCT03709823|Behavioral|Behavioral support|12 behavioral support sessions by a qualified staff member plus supportive literature and online resources
15892306|NCT03709810|Combination Product|Marketed Denture Adhesive (Super Poligrip Max Seal)|The denture adhesive will be applied directly from the tubes. 1.6 g of adhesive per treatment will be applied to each participant's dentures. This dose will be split as 1.00±0.1 g for the maxillary and 0.6±0.1g for the mandibular dentures.
15892307|NCT03709810|Other|No Adhesive|No adhesive will be applied.
15892308|NCT03709797|Procedure|Dry needling in infraspinatus muscle|Dry needling technique with multiple rapid needle insertion.
15892309|NCT03709784|Other|Observational study to examine safety, tolerability, and effectiveness of SPINRAZA® prescribed as part of standard of care|This is an observational study of adult patients with SMA to examine the safety, tolerability, and effectiveness of SPINRAZA® (nusinersen) for up to 30 months.
15892374|NCT03709355|Drug|Atorvastatin|Atorvastatin Film-coated tablets, 80mg
15892375|NCT03709355|Drug|Levonorgestrel+Ethinylestradiol|Levonorgestrel 150 μg + Ethinylestradiol 30 μg, Film-coated tablets
15892376|NCT03709342|Drug|CM4620-IE|single IV infusion on Day 1 over 4 hours
15892377|NCT03709329|Device|Robot Assisted Gait Therapy|The robot-assisted gait treatment will receive 18 treatments per patient for 1 week, 3 times a week, and 6 weeks for 30 minutes a day.
15892423|NCT03709069|Dietary Supplement|Albumin supplementation|Enteral supplementation by albumin of boiled egg as 2mg per kg body weight.
15892911|NCT03705221|Behavioral|Healthy Parent Carers group programme|Peer-led group-based weekly programme.
15892310|NCT03709771|Diagnostic Test|Ambulatory Blood Pressure Measurement|"Baseline: Subjects will undergo an abbreviated physical exam, review changes in medical history since last oncology visit, blood collection, urine collection, blood pressure and heart rate in triplicate, baseline and hyperemic digital velocity time interval (VTI) using pulse amplitude tonometry, cubital vein endothelial cell harvest, and ambulatory 24 blood pressure measurement.
~Follow-up Visit (approx 1 month after starting treatment): Review changes in medications and any medical events that happened since the last visit, an abbreviated physical exam, blood collection, urine collection, blood pressure and heart rate in triplicate, baseline and hyperemic velocity time interval (VTI), digital pulse amplitude tonometry, endothelial cell harvest, and ambulatory 24 blood pressure."
15892311|NCT03709758|Drug|Venetoclax|Venetoclax blocks an important pathway that promotes cell survival in tumor cells that overexpress BCL-2, so venetoclax causes cells to die
15892312|NCT03709758|Drug|Daunorubicin|Chemotherapy is most effective at killing cells that are rapidly dividing.
15892313|NCT03709758|Drug|Cytarabine|Chemotherapy is most effective at killing cells that are rapidly dividing.
15892314|NCT03709745|Drug|Aflibercept Injection [Eylea]|Intravitreal injection is given as described in the arm description
15892315|NCT03709745|Drug|Ranibizumab Injection [Lucentis]|Intravitreal injection is given as described in the arm description
15892316|NCT03709732|Other|no intervention|observational study
15892317|NCT03709719|Drug|Blinatumomab Injection|Blinatumomab 28 μg/day : D1 to D28
15892318|NCT03709706|Drug|Lete-cel|lete-cel will be administered to eligible participants.
15892319|NCT03709706|Drug|Pembrolizumab|Pembrolizumab will be administered to eligible participants.
15892320|NCT03709693|Device|SternaLock Blu|Sternal closure will be accomplished using SternaLock Blu plates and screws in combination with single-wire method of sternal reduction.
15892321|NCT03709680|Drug|Palbociclib|Administered (oral) at 55 mg/m2, 75 mg/m2, or 40 mg/m2, or 95 mg/m2 or 115 mg/m2 on days 1-14 of a 21-day cycle
15892322|NCT03709680|Drug|Temozolomide|Administered at 100 mg/m2 (oral or intravenous), on days 1-5 of a 21-day cycle
15892323|NCT03709680|Drug|Irinotecan|Administered at 50 mg/m2 (intravenous), on days 1-5 of a 21-day cycle
15892324|NCT03709680|Drug|Topotecan|Administered at 0.75 mg/m2 (intravenous), on days 1-5 of a 21-day cycle
15892325|NCT03709680|Drug|Cyclophosphamide|Administered at 250 mg/m2 (intravenous), on days 1-5 of a 21-day cycle
15892326|NCT03709667|Behavioral|EX|An individualized aerobic and resistance-exercise program will be developed for each participant on the basis of a maximal incremental exercise test and strength assessments performed at baseline. This test will measure aerobic capacity (VO2 max) and the metabolic or lactate threshold (VO2θ) (i.e., the level of O2 uptake that defines one's ability to perform prolonged work), using indirect calorimetry with an automated metabolic-measurement system. The intervention will comprise 24 sessions over 8 wk (3x/wk), supervised by a credentialed exercise specialist. Each session will consist of a 5-min warm-up, 30-40 min of aerobic activity on a treadmill, 15-20 min of resistance training, and a 5-min cool-down.
15892327|NCT03709667|Behavioral|CON|Participants attend 50-min sessions 3x/wk matched to EX for staff contact. A counselor will facilitate integrative group discussions, and will conduct a multimedia program addressing various health, wellness and lifestyle topics, such as nutrition, dental care, stress relief, sleep hygiene, relationships, immunizations, health screening, smoking, environmental health, and time management.
15892328|NCT03709654|Biological|NB01|5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of NB01
15892329|NCT03709654|Other|Vehicle Control|5-7 day pretreatment of gold standard benzoyl peroxide therapy to kill resident facial bacterial followed by 11 weeks of daily topical application of vehicle control
15892330|NCT03709641|Device|Restylane Defyne|Restylane is a gel of hyaluronic acid generated by Streptococcus species of bacteria, chemically crosslinked with BDDE, stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL
15892331|NCT03709628|Drug|EB8018 (First-in-class FimH blocker)|"Drug: EB8018 EB8018 is an orally administered, first-in-class, FimH blocker
~• In Part 1, a single oral dose of EB8018 3000 mg will be administered to the 2 sentinel patients in the morning on Day 1. In the multi-dose treatment period (part 1 and 2), multiple oral doses of EB8018 1500 mg will be administered to 2 + 6 patients BID (in the morning and evening) on Days 1 through 13."
15892332|NCT03709615|Behavioral|Internet delivered CBT for social anxiety disorder|"An internet-based CBT for social anxiety based on a protocol from Andersson et al., 2006:
~Internet-based self-help with therapist feedback and in vivo group exposure for social phobia: a randomized controlled trial."
15892333|NCT03709589|Other|Modified Early Warning Score|Modified Early Warning Score
15892334|NCT03709576|Drug|Pevonedistat|To assess the toxicity and efficacy of a combination of Pevonedistat and Azacitidine as post allogeneic hematopoietic stem cell transplant maintenance therapy for non-remission AML.
15892335|NCT03709576|Procedure|transplant|Although hematopoietic stem cell transplantation (HSCT) is curative for many patients with AML, AML in relapse at the time of transplant is still a major challenge with low rates of leukemia-free survival even with an intensive myeloablative conditioning.
15892336|NCT03709576|Drug|Azacitidine|To assess the toxicity and efficacy of a combination of Pevonedistat and Azacitidine as post allogeneic hematopoietic stem cell transplant maintenance therapy for non-remission AML.
15892337|NCT03709563|Dietary Supplement|Oral Nutraceutical Supplement|Standardized Botanicals. Take 4 capsules by mouth daily with a meal
15892338|NCT03709563|Dietary Supplement|Placebo|Placebo. Take 4 capsules by mouth daily with a meal
15892339|NCT03709550|Drug|Decitabine|Given IV
15892340|NCT03709550|Drug|Enzalutamide|Given PO
15892378|NCT03709329|Device|Conventional Gait Therapy|The conventional gait therapy group receives a total of 18 classical gait training sessions once a day for 30 minutes and three times a week for 6 weeks. Classical gait training consisted of exercise training based on neurophysiological theories such as Bobath, restraint of rigid and cooperative movements by therapists, exercise training in sitting or standing posture, Gait training and balance training, weight training of the paralyzed lower limb.
15892379|NCT03709316|Drug|ZL-2306 (Nirapairb)|The starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count
15892380|NCT03709316|Drug|Placebo Comparator|The starting dose is 300mg or 200mg QD based on the subject's baseline body weight or baseline platelet count
15892341|NCT03709537|Behavioral|Mental Health Peer Workforce Support|"Supervisors and peer workers will participate in trainings covering effective peer services, trauma-informed effective peer supervision, and responsibilities of peer workers in a supervising relationship. A monthly Supervisors of Peer Workers meeting will support site change efforts. Sites will create an implementation team to work within their site to implement the training received.
~Peer Workers will enroll in a peer mentoring program, where they serve as peer mentors matched with fellow peer mentors. Recovery International and the Los Angeles Department of Mental Health will encourage peer workers to attend Recovery International meetings. Emotional Health Association will refer Peer Workers and their Supervisors in the intervention group to self-help support groups that reduce stress and increase resiliency."
15892342|NCT03709524|Device|Airtraq + fiberoptic|video laryngoscope with a monitor
15892343|NCT03709524|Device|Airtraq|video laryngoscope with a monitor
15892344|NCT03709524|Device|Nasotracheal Airtraq + styletted tube|video laryngoscope with a monitor
15892345|NCT03709511|Other|Cardiac rehabilitation|Cardiac rehabilitation consists of exercise rehabilitation, psychological counseling and Dietary guidance.
15892346|NCT03709485|Other|rectal swab for microbial culture.|Rectal swab and culture.
15892347|NCT03709472|Behavioral|Computer Assisted CIFFTA|This is a hybrid intervention that includes individual work with the adolescent (e.g., Motivational Interviewing, diary card identification of triggers), computer assisted psychoeducational work, and intensive family therapy interventions.
15892348|NCT03709472|Behavioral|Behavioral: Traditional face-to-face treatment-no technology|Community agencies provide mostly individual counseling but may add some family involvement in treatment planning.
15892349|NCT03709459|Drug|Doxycycline|Participants will be asked to take Doxycycline 100mg/day for 12months duration
15892350|NCT03709446|Drug|Leflunomide|Single agent leflunomide
15892351|NCT03709433|Behavioral|ACT groups and mobile app|See arm description.
15892352|NCT03709420|Drug|Placebo|Placebo capsule to match active drug
15892353|NCT03709420|Drug|FOR-6219|FOR-6219 capsule
15892354|NCT03709407|Other|cervical stimuli|Manouvres Godoy
15892355|NCT03709407|Other|terminus|Manouvres Vodder
15892356|NCT03709407|Other|Placebo|placebo manouvre
15892357|NCT03709407|Other|Control group|lie down
15892358|NCT03709394|Procedure|Full utrasound guidance|The target vein is directly identified by portable ultrasound device and the complete procedure of peripheral venous cathether insertion is controlled by ultrasound guidance in real time
15892359|NCT03709394|Procedure|Partial ultrasound guidance|The target vein is directly identified by ultrasound but the procedure of peripheral venous cathether insertion is performed conventionally, without ultrasound guidance
15892360|NCT03709394|Procedure|No ultrasound guidance|The target vein is identified and peripheral venous catheter is inserted by conventional approach without use of any guiding devices
15892361|NCT03709381|Drug|Low Dose Cosyntropin (ACTH) stimulation test|Cosyntropin 1 mcg IV given to subjects at t=0
15892362|NCT03709381|Drug|High Dose Cosyntropin (ACTH) stimulation test|Cosyntropin 250 mcg IV given to subjects at t=60
15892363|NCT03709368|Other|Hardware|Community sessions will be provided to each of the sub-villages (n=27) teaching participants how to build a tippy tap, how to build an improved latrine, and how to make liquid soap. In addition, an existing water gravity flow scheme will be rehabilitated and extended, 350 tippy taps and 350 pans for pour flush latrines will be distributed, and sanitation blocks will be built in four schools. Within these schools, SWASH school hygiene clubs will be organized.
15892364|NCT03709368|Behavioral|CLTS|CLTS sanitation and HW sessions will be given. A first session will focus on sanitation, covering 7 exercises: 1) sanitation or social map, 2) transect walk, 3) shit calculation, 4) medical expenses, 5) shit flow diagram, and 6) water/shit demo, 7) community declaration. A second session will focus on HW, involving 10 exercises: 1) anal cleansing materials, 2) shit and shake, 3) cassava/egg demonstration, 4) charcoal smearing, 5) smelly hands, 6) feces on baby nappies, 7) scratch & smell, 8) wall contamination, 9) food sharing, 10) dirt under fingernails. These sessions will take approximately 3-5 hours each. Follow-up community meetings and household visits will take place to monitor improvement.
15892365|NCT03709368|Behavioral|PHAST|PHAST sessions are based on the 'PHAST step-by-step guide: A participatory approach for the control of diarrhoeal disease' of the World Health Organization. Considering the overlap with some CLTS activities, only a selection of the full guideline will be enrolled, namely: 1) Health problems in our community, 2) Good and bad hygiene behaviors, 3) Investigating community practices, 4) How diseases spread, 5) Blocking the spread of disease, 6) Selecting the barriers, 7) Choosing sanitation improvements, and 8) Choosing improved hygiene behaviors. These 8 activities will be enrolled in approximately 40 community groups. Each activity will take between 30 minutes - 2 hours to complete.
15892366|NCT03709368|Behavioral|RANAS|Nine household visits of 20-40 min each will be offered at a frequency of one visit every two months. The content of these add-on visits is based on the RANAS manual: 'Systematic Behavior Change in Water, Sanitation and Hygiene - A practical guide to using the RANAS approach' (www.ranasmosler.com). First, baseline data is gathered through a questionnaire to better understand the context that is at play. Next, this data is analyzed in a do'er non-do'er analysis. Only those behavioral factors that are significantly different between do'ers and non-do'ers will be included in the intervention, as these are, at least theoretically, considered to be decisive for HW and latrine use behavior in the current setting.
15892367|NCT03709368|Behavioral|mini-RANAS|Nine household visits of 20-40 min each will be offered at a frequency of one visit every two months. The content of the mini-RANAS add-on intervention is based on the 'Norm Behavior Change Techniques' from the RANAS manual 'Systematic Behavior Change in Water, Sanitation and Hygiene - A practical guide to using the RANAS approach' (www.ranasmosler.com). During the mini-RANAS household visits, emphasis will be put on norms and volunteers will encourage participants to become a role model by improving HW and sanitation infrastructure and behavior.
15892368|NCT03709368|Other|Placebo poster|One household visit will be offered. During this visit, a placebo poster will be distributed focusing on first aid. The topics to be discussed are burns, cuts and grazes. The main goal of this household visit is to avoid jealousy among the control cohort.
15892369|NCT03709355|Drug|Elpida®|Elpida® capsules, 20mg
15892370|NCT03709355|Drug|Rifampin|Rifampin capsules, 150mg
15892371|NCT03709355|Drug|Rifabutin|Rifabutin capsules, 150mg
15892372|NCT03709355|Drug|Clarithromycin|Clarithromycin Film-coated tablets, 250mg
15892382|NCT03709277|Behavioral|Pharmacist-Driven Intervention|The pharmacist will investigate patient assistance options for patients who cannot afford their specialty medication, reach out to prescribers when needed to address intolerance/adverse effects, improve health literacy, recommend options for forgetfulness, make every effort to reach patient, address clinical and financial barriers to unresponsiveness (lack of lab completion, not returning to clinic, etc.)
15892383|NCT03709264|Drug|Amino Acids|Patients randomized to experimental arm receive a continuous infusion of a balanced mixture of amino acids in a dose of 2 g/kg ideal body weight/day (to a maximum 100 g/day) from the operating room admission up to either death, start of RRT, ICU discharge or 72 hours after treatment initiation, trough a central venous line
15892384|NCT03709264|Drug|Placebos|Placebo: standard treatment
15892385|NCT03709251|Behavioral|High Intensity Walking|Intense walking activity at an intensity of 70-80% of the maximum heart rate
15892386|NCT03709251|Behavioral|Casual Speed Walking|Moderate intensity (50-60% of Heart Rate maximum)
15892387|NCT03709238|Behavioral|Thermal stimulation|Thermal stimulation
15892388|NCT03709225|Behavioral|Music-based meditation|The program is designed to incorporate music-based meditation practices and music making activities (e.g., guitar, drums) to help promote relaxation during cancer treatment
15892389|NCT03709212|Other|interviews|20 participants will undergo individual semi-structured interviews, 60 will undergo one of 6 focus groups comprising of 10 participants of the same gender and ethnicity.
15892390|NCT03709199|Diagnostic Test|Ventilation Inhomogeneity|Ventilation inhomogeneity will be measured using the Lung Clearance Index (LCI), derived from multiple breath Nitrogen washout during tidal breathing, measured by a mouthpiece or mask covering nose and mouth.
15892391|NCT03709199|Diagnostic Test|Diaphragm Ultrasound|Diaphragm thickness and contractile activity measured during tidal breathing.
15892392|NCT03709199|Diagnostic Test|Respiratory Inductance Plethysmography|Measure of thoraco-abdominal asynchrony during tidal breathing
15892393|NCT03709199|Diagnostic Test|Spirometry|Measurement of Forced Expiratory Volume (FEV1), Forced Vital Capacity and other lung volumes using standard pulmonary function techniques
15892394|NCT03709199|Diagnostic Test|Functional Residual Capacity|Measurement using body box plethysmography of functional residual capacity and other lung volumes using standard pulmonary function techniques
15892395|NCT03709199|Diagnostic Test|MIP/MEP|Measurement of maximal inspiratory and expiratory pressures during airway occlusion
15892396|NCT03709199|Diagnostic Test|6 minute walk test|Measurement of cardio-respiratory function and capabilities during treadmill walking for 6 minutes.
15892397|NCT03709199|Diagnostic Test|Neurocognitive Testing|Detailed in person neuro-cognitive testing using standardized inventories using either the Battelle Developmental Inventory, second edition (Battelle-2) (age birth to 5 years 11 months) and the Wechsler Intelligence Scale for Children, fifth edition (WISC-5, for age 6 years to 19 years).
15892398|NCT03709199|Diagnostic Test|Emotional Health Assessment|In person and written assessments of children and parents using the Behavioral Assessment System for Children, third edition (BASC-3) for children ≥ 2 years and the UCLA PTSD Reaction Index (UCLA RI) for children ≥ 8 years.
15892399|NCT03709199|Diagnostic Test|Health Related Quality of Life|Standardized instruments to assess (in person, over the phone, or via mail) health related quality of life in children. Parent and child questionnaires.
15892400|NCT03709199|Diagnostic Test|Functional Status|Survey of overall functional status, administrated by asking a series of questions to patient and families.
15892401|NCT03709199|Diagnostic Test|Respiratory Status Questionnaire|Survey of respiratory health, administrated by asking a series of questions to patient and families.
15892402|NCT03709173|Behavioral|FuRST 2.0|Round 2 of cognitive pre-testing for a new functional rating scale
15892403|NCT03709160|Drug|Bumetanide 1 MG|all patients will be taking the treatment recommended by heart failure guidelines
15892404|NCT03709147|Drug|Metformin Hydrochloride|Metformin 1500 mg/day up to disease progression or unacceptable toxicity Every-21-days, 5-day Fasting-mimicking diet (FMD)
15892405|NCT03709147|Drug|Cisplatin|Intravenous cisplatin, administered at a dosage of 75 mg/mq every three weeks for a maximim of 4 consecutive cycles
15892406|NCT03709147|Drug|Carboplatin|Carboplatin at an area-under-the-curve (AUC) of 5, administered intravenously every-three weeks for a maximum of 4 consecutive cycles
15892407|NCT03709147|Drug|Pemetrexed|Pemetrexed, administered intravenously at the dose of 500 mg/mq every-three weeks up to a maximum of 4 cycles in combination with platinum compounds, and then as a maintenance treatments in patients not undergoing disease progression after the first 4 chemotherapy cycles
15892408|NCT03709147|Dietary Supplement|Fasting-mimicking diet|5-day fasting-mimicking diet regimen, consisting of 700 KCal on day 1, 300 KCal on days 2-4, and 450 KCal on day 5, to be repeated every three weeks up to a maximum of 4 cycles
15892409|NCT03709147|Drug|Pembrolizumab|Pembrolizumab, administered intravenously at the flat dose of 200 mg every-three weeks up to a maximum of 4 cycles in combination with platinum compounds, and then as a maintenance treatments in patients not undergoing disease progression after the first 4 chemotherapy cycles
15892410|NCT03709134|Diagnostic Test|Genomic Markers (CTC/ctDNA)|This is a non-interventional study.
15892411|NCT03709121|Drug|Reproxalap Ophthalmic Solution (0.25%)|Reproxalap Ophthalmic Solution (0.25%) dosed twice.
15892412|NCT03709121|Drug|Reproxalap Ophthalmic Solution (0.5%)|Reproxalap Ophthalmic Solution (0.5%) dosed twice.
15892413|NCT03709121|Drug|Vehicle Ophthalmic Solution|Vehicle Ophthalmic Solution dosed twice.
15892414|NCT03709108|Other|SI-Informed Bolus Calculator|The SI-Informed Bolus Calculator will be used to dose the dinner meal insulin bolus during the Experimental Admission
15892415|NCT03709095|Other|Sprint interval training|Participants utilized the arm ergometer for improving aerobic exercise capacity
15892416|NCT03709095|Other|moderate intensity continuous training|Participants utilized the arm ergometer for improving aerobic exercise capacity
15892417|NCT03709082|Drug|Palbociclib 75mg|Oral Administration
15892418|NCT03709082|Drug|Letrozole 2.5mg|Oral Adminstration
15892419|NCT03709082|Drug|T-DM1|Intravenous Administration
15892420|NCT03709082|Drug|Palbociclib 100mg|Oral Administration
15892421|NCT03709082|Drug|Palbociclib 125mg|Oral Administration
15892422|NCT03709082|Drug|Palbociclib|Oral Administration
15907317|NCT03593018|Drug|Gemcitabine|Gemcitabine injection
15892424|NCT03709056|Drug|HSK3486|HSK3486 intravenous (iv) 0.4(0.5) mg/kg for induction, and 0.2 (0.15)mg/kg top-ups for maintenance. 0.3(0.375) mg/kg for induction and 0.15 (0.113)mg/kg for maintenance in adults of 65-70 years old
15892425|NCT03709056|Drug|Propofol|Propofol iv 2.0 mg/kg for induction, and 1.0 mg/kg top-ups for maintenance. 1.5 mg/kg for induction and 0.75mg/kg for maintenance in adults of 65-70 years old.
15892426|NCT03709043|Drug|Standardized kudzu|Standardized kudzu
15892427|NCT03709043|Other|Placebo|Placebo
15892428|NCT03709030|Diagnostic Test|magnetic resonance cholangiopancreatography (MRCP)|magnetic resonance imaging of liver, gall bladder, pancreas
15892429|NCT03709017|Drug|Ponatinib|Iclusig 45mg, 15mg
15892430|NCT03709004|Other|Pacifier|Pacifier given to mom.
15892431|NCT03708991|Diagnostic Test|IVF combined with PGT-A|trophectoderm biopsy to test the ploidy state of the IVF embryos
15892432|NCT03708991|Diagnostic Test|ICSI combined with PGT-A|trophectoderm biopsy to test the ploidy state of the ICSI embryos
15892433|NCT03708978|Diagnostic Test|mammography|When a woman comes to the clinic to receive mammography. Then a radiologist will give a BI-RADS classification after reviewing the images. If a BI-RADS 4/5 is obtained, the woman will receive pathological biopsy to ensure there is a benign or malignant lesion. If a BI-RADS 3 is obtained, the woman will be followed up by a half-year interval until two year after the first mammography. At each follow up, she will receive mammography. If a BI-RADS 4/5 is obtained at follow up, she will receive pathological biopsy; if a BI-RADS 1/2/3 is obtained at follow up, she will be followed up by a half-year interval until two year. If a BI-RADS 1/2 is obtained at the first mammography, the woman will receive a second mammography after two year. During the study period, breast examination and results will be recorded for every subject. Radiologists will give the diagnosis with and without AI support.
15892434|NCT03708965|Drug|JR-141|IV infusion (lyophilized powder)
15892435|NCT03708939|Dietary Supplement|Glucose|Daily consumption of 5g of glucose, for 14 days.
15892436|NCT03708939|Dietary Supplement|Aspartame|Daily consumption of six commercially available sachets containing aspartame and glucose as bulking agent (1g each sachet), for 14 days.
15892437|NCT03708939|Dietary Supplement|Sucralose|Daily consumption of six commercially available sachets containing sucralose and glucose as bulking agent (1g each sachet), for 14 days.
15892438|NCT03708939|Dietary Supplement|Saccharin|Daily consumption of six commercially available sachets containing saccharine and glucose as bulking agent (1g each sachet), for 14 days.
15892439|NCT03708939|Dietary Supplement|Stevia|Daily consumption of six commercially available sachets containing Stevia and glucose as bulking agent (1g each sachet), for 14 days.
15892440|NCT03708939|Other|No Supplement|Follow up without any dietary supplementation.
15892441|NCT03708926|Drug|Abaloparatide|abaloparatide injection pen
15892442|NCT03708926|Drug|Placebo|placebo injection pen
15892443|NCT03708913|Device|Hypothalamic Deep Brain Stimulation|One-year continuous hypothalamic deep brain stimulation
15892444|NCT03708900|Drug|LCI699|osilodrostat (LCI699) is in the form of tablets for oral administration and comes in the following tablet strengths: 1 milligram (mg), 5 mg, and 10mg.
15892445|NCT03708887|Drug|Low dose omega-3 fatty acid supplementation|Omega-3 fatty acids capsules, 1 g/d by mouth for 1 year
15892446|NCT03708887|Drug|High dose omega-3 fatty acid supplementation|Omega-3 fatty acids capsules, 3 g/d by mouth for 1 year
15892447|NCT03708887|Drug|Control drug|Matching placebo capsules,1 g/d by mouth for 1 year
15892448|NCT03708861|Drug|maraviroc (300 mg QD) + atazanavir/ritonavir (300 and 200 mg /100 mg QD)|"Phase 1: switch from tenofovir disoproxil fumarate/emtricitabine (200/245 mg QD)+ atazanavir/ritonavir (300 /100 mg QD) to maraviroc (300 mg QD) + atazanavir/ritonavir (300 /100 mg QD).
~Phase 2: switch from maraviroc (300 mg QD) + atazanavir/ritonavir (300 /100 mg QD) to maraviroc (300 mg QD) + atazanavir/ritonavir (200 /100 mg QD)"
15892449|NCT03708848|Drug|Esomeprazole|Proton pump inhibitor
15892450|NCT03708848|Drug|Bismuth Potassium Citrate|Gastric mucosal protective drug with anti-H. pylori effect
15892451|NCT03708848|Drug|Clarithromycin|antibiotic for H. pylori eradication
15892452|NCT03708848|Drug|Metronidazole|antibiotic for H. pylori eradication
15892453|NCT03708848|Drug|Levofloxacin|antibiotic for H. pylori eradication
15892454|NCT03708848|Drug|Tetracycline|antibiotic for H. pylori eradication
15892455|NCT03708835|Other|Transitional care model|In this study, the feasibility and impact of a transitional care model from hospital to home for stroke patients and caregivers will be tested.
15892456|NCT03708822|Drug|Docetaxel and Cisplatin and Nimotuzumab|All patients enrolled in the study will accept docetaxel combined with cisplatin and Nimotuzumab as their firstline chemotherapy
15892457|NCT03708809|Device|Intrauterine system|13.5 mg levonorgestrel-releasing intrauterine system
15892458|NCT03708809|Other|Alternative contraception to intrauterine system|Alternative contraception including contraception pills, hormonal patches, hormonal vaginal , condomsring,
15892459|NCT03708796|Diagnostic Test|SIRS, qSOFA, NEWS, RETTS scores evaluation|Simple data collection from regular vital signs recordings during the initial phase of care management in the emergency department. Missing data is then possibly completed by the physician when made available during the regular medical management of the patient.
15892460|NCT03708783|Procedure|laparoscopic Spleen-Preserving No. 10 Lymph Node Dissection|For patients with locally advanced upper or middle third gastric cancer, laparoscopic total gastrectomy with D2 lymphadenectomy including spleen-preserving No. 10 lymph node dissection is performed.
15892461|NCT03708770|Device|everlinQ endoAVF System|
15892462|NCT03708757|Other|Post isometric relaxation - Group I|Post isometric relaxation (PIR) techniques are used by orthopedic manual physical therapists to enhance the flexibility of muscles and to increase the joint range of motion
15892463|NCT03708757|Other|Eccentric Muscle contraction - Group II|and Eccentric muscle energy techniques(EME) techniques are used by orthopedic manual physical therapists to enhance the flexibility of muscles and to increase the joint range of motion
15892464|NCT03708744|Drug|A: M207 3.8mg, 30 min, upper arm|A: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (upper arm application)
15892465|NCT03708744|Drug|B: M207 3.8 mg, 30 min, thigh|B: M207 3.8 mg administered as two 1.9 mg patches, 30 min wear time (thigh application)
15892534|NCT03708185|Dietary Supplement|Beta-alanine|N/A: see arm description
15892466|NCT03708744|Drug|C: M207 3.8 mg, 1 hr, upper arm|C: M207 3.8 mg administered as two 1.9 mg patches, 1 hour wear time (upper arm application)
15892467|NCT03708744|Drug|D:zolmitriptan nasal spray|D: 2.5 mg/0.1 mL intranasal zolmitriptan
15892468|NCT03708718|Drug|Prednisolone 5 mg|5mg prednisolone, once a day for 6 months
15892469|NCT03708718|Drug|Placebo oral capsule; From August 2020 'no additional treatment'|Matched placebo capsule, once a day for 6 months; From August 2020 - no additional treatment above standard of care medication
15892470|NCT03708705|Other|Risk model of tumor relapse|High risk factor model of tumor relapse after liver transplantation
15892471|NCT03708692|Behavioral|Group F|After general anesthesia, the time of return of the behaviors such as opening the eyes, fulfilling the orders or saying the age will be recorded and evaluated as the recovery criteria. In the postop recovery period, the patient will be subjected to mini mental state testing (MMST) and cognitive functions will be evaluated.
15892472|NCT03708666|Other|Telemonitoring of blood pressure|Blood pressure monitoring at least once a week.
15892473|NCT03708640|Other|Digital Activity Tracker|Group wears physical activity tracker and receives physical activity feedback information informed by the tracker
15892474|NCT03708640|Other|Smart Text Messaging|"Group receives personalized, health coaching via smart text messages"
15892475|NCT03708640|Other|Physical Activity Counseling|Group receives baseline counseling on physical activity
15892476|NCT03708627|Drug|Bimatoprost Ophthalmic|Bimatoprost, aka Lumigan, one drop in one eye nightly
15892477|NCT03708614|Other|Controlled energy diet with elevated protein intake|Participants will be counseled to elevate protein and control energy intake for ten consecutive weeks. Protein intake will be increased in the range of 20-30% of total daily caloric intake. Each participant's diet will also be modified to implement controlled energy intake. Controlled energy intake will be defined as being isocaloric with the participant's current dietary intake.
15892478|NCT03708588|Drug|Ticagrelor|Chewed
15892479|NCT03708588|Drug|Ticagrelor|Integral
15892480|NCT03708562|Device|everlinQ endoAVF System|The everlinQ device is a single-use disposable device. The everlinQ catheter system consists of two flexible, magnetic catheters. Once the catheters are properly inserted and aligned, the magnets contained in each catheter attract to one another, approximating the vessels while simultaneously aligning the electrode with the backstop. Radiofrequency (RF) energy is delivered to the electrode whereby the arterio-venous fistula (AVF) is created.
15892483|NCT03708536|Drug|S-1|S-1 is administered orally on days 1 to 14 of a 21-day cycle. Patients are assigned on the basis of body surface area (BSA) to receive one of the following oral doses twice daily: 40 mg (BSA <1.25m2), 50 mg (BSA >1.25 to <1.50 m2), or 60 mg (BSA >1.50 m2).
15892484|NCT03708536|Drug|Bevacizumab|Bevacizumab (7.5 mg/kg) is administered by intravenous infusion over the course of 30 to 90 min on day 1 of each 3-week cycle.
15892485|NCT03708536|Drug|Capecitabine|Capecitabine 2000mg/m2/d is administered orally on days 1 to 14 of a 21-day cycle.
15892486|NCT03708510|Device|Restorative materials- Filtek Silorane|Filtek Silorane
15892487|NCT03708510|Device|Restorative materials-Kalore|Kalore
15892488|NCT03708510|Device|Preparation-Er,Cr:YSGG Laser|Er,Cr:YSGG Laser
15892489|NCT03708510|Device|Preparation- Diamond Bur|Bur
15892490|NCT03708497|Drug|carbetocin|Carbetocin 100 microgram will be applied intravenously in a short infusion over about a minute
15892491|NCT03708497|Drug|Tranexamic acid plus misoprostol|1000mg oral TA at the end of the first stage of labor plus 600 mg buccal misoprostol after delivery of the baby. A buccal route, in which the tablets are placed in the cheek for 30 min after which any remnants are swallowed.
15892492|NCT03708497|Drug|misoprostol|600 mg buccal misoprostol after delivery of the baby. A buccal route, in which the tablets are placed in the cheek for 30 min after which any remnants are swallowed.
15892493|NCT03708484|Other|Aerobic Interval Training|"Aerobic Interval Training Patients in this group will perform 6 minutes of cycling followed by 3 minutes of pause and again 6 minutes of cycling followed by 3 minutes of pause and finally 6 minutes of treadmill followed by 3 minutes of rest.
~both groups will perform cool down exercises that include again breathing exercises, stretching and active exercises."
15892494|NCT03708484|Other|Aerobic + Resistive Interval Training|"Aerobic + Resistive Interval Training Patients in this group; first set will perform 3 minute of cycling ,1 set of hand grippers 1.5 to 2.5 lbs (10 to 12 reps) and 1 set of biceps resistive exercises 1 Kg to 3 kg (10 to 12 reps) followed by 3minute of pause. In second set patient will perform 3 minutes of stationary cycling , 1 set of quadriceps resistive exercises 1 to 3 Kg (10 to 12 reps) again followed by 3 minutes of pause and in third set patient will perform 3 minutes of treadmill walk at 1.5 to 4 speed, and 1 set of standing ankle pumps (10 to 12 reps).
~both groups will perform cool down exercises that include again breathing exercises, stretching and active exercises."
15892495|NCT03708471|Procedure|Hybrid ablation|This intervention including thoracoscopic surgical ablation, percutaneous catheter ablation and cardiovascular risk control.
15892496|NCT03708471|Procedure|Thoracoscopic surgical ablation|This intervention including thoracoscopic surgical ablation and cardiovascular risk control.
15892497|NCT03708458|Drug|indomethacin suppository|the investigators aimed to perform a comparative study, evaluating the efficacy of three prophylactic approaches aiming to reduce the risk of PEP, using indomethacin and/or N-acetylcysteine -NAC, in different regimens
15892498|NCT03708458|Drug|N-acetylcysteine (NAC)|the investigators aimed to perform a comparative study, evaluating the efficacy of three prophylactic approaches aiming to reduce the risk of PEP, using indomethacin and/or N-acetylcysteine -NAC, in different regimens
15892499|NCT03708445|Diagnostic Test|Cytology staining|"Two staining will be performed in cytology specimens obtained from same patient. The cytology specimen will be obtained through brushing cytology using endoscopic retrograde cholangiopancreatography
~conventional cytology staining method
~new cytology staining method using antibody of aminoacyl-tRNA synthetases"
15892535|NCT03708185|Dietary Supplement|Placebo|N/A: see arm description
15892500|NCT03708419|Other|Optimal diet|Based on a 7-points OGTT, participants will be classified as MIR or LIR. The hypothesized optimal diet for MIR has a moderate fat content which is high in mono- unsaturated fatty acids (HMUFA) with a macronutrient breakdown of 38 E% from fat (20% MUFA, 10% polyunsaturated fatty acids (PUFA), 8% saturated fatty acids (SFA)), 48 E% from carbohydrates (CHO, 35% complex), and 14 E% from protein (35-40% plant protein). The hypothesized optimal diet for LIR is low in fat, high in protein (LFHP) and increased fiber with a macronutrient breakdown of <28 E% from fat (10% MUFA, 10% PUFA, 8% SFA), 48 E% from CHO (35% complex), and 24 E% from protein (35-40% plant protein), and an additional supplement of 6g of soluble fiber per day. Participants wil be randomly allocated to one of the two diets.
15892501|NCT03708419|Other|Suboptimal diet|"The optimal diet for the other metabolic phenotype will be considered as suboptimal/ control diet. For the MIR phenotype this is the high protein, high fiber, low fat diet; for the LIR phenotype this is the high monounsaturated fatty acid diet. See the description above."
15892502|NCT03708393|Device|Imagio (IUS+OA)|The Imagio ultrasound and opto-acoustic images to be reviewed as part of the reader study
15892503|NCT03708393|Device|Imagio Ultrasound|Imagio ultrasound images to be reviewed as part of the reader study
15892504|NCT03708393|Device|Mammography|Mammography images as available per standard of care
15892505|NCT03708380|Behavioral|Dietary intervention|Over a 60-day period, participants will receive healthy lunches that provide a hand-delivered healthy alterative to their current diets.
15892506|NCT03708367|Device|LipiFlow Thermal Pulsation System|Treatment at preoperative visit for study group
15892507|NCT03708367|Device|LipiFlow Thermal Pulsation System|Treatment at 3 month visit as the cross-over group
15892508|NCT03708354|Drug|placebo softgel|One 430 mg olive oil softgel daily for 24 weeks. Each placebo softgel of 430 mg olive oil will contain no tocotrienol or tocopherols at detectable levels.
15892509|NCT03708354|Drug|DeltaGold® Tocotrienol 70%|Each TT softgel (DeltaGold® Tocotrienol 70%) contains 430 mg TT (90% δ-TT+10% γ-TT) with a 70% purity, representing 300 mg TT.
15892510|NCT03708341|Drug|Melatonin 5 mg|Systematic daily administration of melatonin 5 mg during patient's ICU stay
15892511|NCT03708341|Drug|Placebo Oral Tablet|Systematic daily administration of placebo during patient's ICU stay
15892512|NCT03708328|Drug|RO7121661|RO7121661 will be administered intravenously (IV) with a flat dose on the schedule described for each study arm.
15892513|NCT03708315|Drug|Dexmedetomidine Hydrochloride|Dexmedetomidine Hydrochloride
15892514|NCT03708315|Drug|Placebos|Placebo
15892515|NCT03708302|Procedure|Bilateral serratus plane block|Ultrasound guided bilateral serratus plane block will be performed at the level of 4th rib in anterior axillary line. After skin infiltration with 1% lidocaine, 80mm 22G block needle will be inserted at the caudal aspect of the ultrasound probe and advanced in-plane to target the fascial plane directly below the serratus muscle. Once the tip is verified in the correct position, 20mls of 0.2% ropivacaine will be injected in the plane in 5 mls aliquot after aspiration on each side. Ultrasound guided bilateral parasternal infrapectoral plane block will be performed at the level of 4th rib, lateral to the sterum. After skin infiltration with 1% lidocaine, 80mm 22G block needle will be inserted at the caudal aspect of the ultrasound probe and advanced in-plane to target the fascial plane directly below the pectoralis major muscle. Once the tip is verified in the correct position, 20mls of 0.2% ropivacaine will be injected in the plane slowly in 5 ml aliquots after aspiration on each side.
15892516|NCT03708302|Procedure|Bilateral parasternal infrapectoral block|"Ultrasound guided bilateral serratus plane block will be performed at the level of 4th rib in anterior axillary line. After skin infiltration with 1% lidocaine, 80mm 22G block needle will be inserted at the caudal aspect of the ultrasound probe and advanced in-plane to target the fascial plane directly below the serratus muscle. Once the tip is verified in the correct position, 20 mls of 0.9% saline will be injected in the plane in 5 mls aliquot after aspiration on each side.
~Ultrasound guided bilateral parasternal infrapectoral plane block will be performed at the level of 4th rib, lateral to the sterum. After skin infiltration with 1% lidocaine, 80mm 22G block needle will be inserted at the caudal aspect of the ultrasound probe and advanced in-plane to target the fascial plane directly below the pectoralis major muscle. Once the tip is verified in the correct position, 20 mls of 0.9% saline will be injected in the plane slowly in 5 ml aliquots after aspiration on each side."
15892517|NCT03708289|Radiation|DXA scan|total and hip and spine dual energy x-ray absorptiometry
15892518|NCT03708289|Other|Achilles bone US|
15892519|NCT03708289|Other|Medical body composition measurements|
15892520|NCT03708289|Other|Resting energy expenditure measurement|
15892521|NCT03708276|Other|My MS Toolkit|My MS Toolkit, a web-based self-management intervention designed to help persons with Multiple Sclerosis self-manage fatigue, pain, and depressed mood.
15892522|NCT03708263|Device|Excel V 532nm (KTP) green Laser|Each subject's face will be divided in half and labeled as A (Right Side of the Face) or B (Left Side of Face). The allocation of active comparator and experimental treatment arms will be determined by randomization
15892523|NCT03708263|Device|PHOTOLASE PLV 585 nm yellow laser|Each subject's face will be divided in half and labeled as A (Right Side of the Face) or B (Left Side of Face). The allocation of active comparator and experimental treatment arms will be determined by randomization
15892524|NCT03708237|Drug|Ropinirole|ROPINIROLE has been approved by Health Canada for the treatment of idiopathic Parkinson's disease. Immediate release ropinirole is an orally administered non-ergoline dopamine agonist that is extensively metabolized by the liver. Ropinirole has not been approved by Health Canada for the treatment of moderate to severe RLS.
15892525|NCT03708237|Drug|Gabapentin|GABAPENTIN has been approved by Health Canada for the management of epilepsy. Immediate release gabapentin is an orally administered anticonvulsant primarily excreted through the kidneys. Gabapentin has not been approved by Health Canada for the treatment of moderate to severe RLS.
15892526|NCT03708237|Drug|Placebos|Opaque gel capsules filled with methylcellulose 1500 filler
15892527|NCT03708224|Biological|Atezolizumab|Given intravenously (IV)
15892528|NCT03708224|Biological|Tocilizumab|Given IV
15892529|NCT03708224|Biological|Tiragolumab|Given IV
15892530|NCT03708211|Drug|TAK-931 PIC|TAK-931 PICs.
15892531|NCT03708211|Drug|TAK-931 Tablet|TAK-931 Tablets.
15892532|NCT03708211|Drug|Esomeprazole|Esomeprazole Tablets.
15892533|NCT03708198|Drug|Liposomal Bupivacaine|intercostal block
15907906|NCT03588390|Drug|Placebo|Placebo to low strength tablet
15892536|NCT03708172|Device|Repetitive Transcranial Magnetic Stimulation|Intermittent TBS (iTBS) rTMS applied to the left Dorsolateral Prefrontal Cortex (DLPFC) + continuous TBS (cTBS) rTMS applied to the right DLPFC. The order will be counterbalanced. Administration of this treatment takes roughly 10 minutes. This treatment will be applied daily, 5 days/week, for 4 weeks.
15892537|NCT03708172|Other|Cognitive Training|Computer-based cognitive training designed to enhance executive function
15892538|NCT03708172|Other|sham Cognitive Training|Computer-based inactive sham training
15892539|NCT03708159|Device|active tDCS + mindfulness meditation|Participants are provided with an activation code. This code will unlock a single session with the pre-set 30 minute duration and intensity (direct current 2mA, current density 0.80A/m2, with anode over the left and cathode over the right dorsolateral prefrontal cortex, respectively). These devices will be set to active. Each tDCS sessions will be delivered in combination with a guided mindfulness meditation that we have recorded.
15892540|NCT03708159|Other|sham tDCS + mindfulness meditation|Participants are provided with an activation code. This code will unlock a single session with the pre-set 30 minute duration and intensity (direct current 2mA, current density 0.80A/m2, with anode over the left and cathode over the right dorsolateral prefrontal cortex, respectively). These devices will be set to sham. Each tDCS sessions will be delivered in combination with a guided mindfulness meditation that we have recorded.
15892541|NCT03708146|Drug|BIA 5-1058|"25 mg and 100 mg tablets; Oral, once-daily, from Day 1 to Day 10. In Cohorts 1, 3, 5, 7 and 9 (fasted), BIA 5-1058 will be orally administered in the morning after a minimum of 8 h fast. Subjects will remain fasted until 4 h post-dose and will receive lunch approximately 4 h after dosing.
~In Cohorts 2, 4, 6, 8 and 10 (fed), BIA 5-1058 will be orally administered in the morning after a moderate breakfast (containing approximately 550 kcal with fat contributing approximately 150 kcal). The meal should be consumed over a maximum period of 25 min, with dosing occurring 30 min after the start of the meal.
~Each dose will be administered with 240 mL water."
15892542|NCT03708146|Drug|Placebo|"matching placebo tablet; Oral, once-daily, from Day 1 to Day 10. In Cohorts 1, 3, 5, 7 and 9 (fasted), placebo will be orally administered in the morning after a minimum of 8 h fast. Subjects will remain fasted until 4 h post-dose and will receive lunch approximately 4 h after dosing.
~In Cohorts 2, 4, 6, 8 and 10 (fed), placebo will be orally administered in the morning after a moderate breakfast (containing approximately 550 kcal with fat contributing approximately 150 kcal). The meal should be consumed over a maximum period of 25 min, with dosing occurring 30 min after the start of the meal.
~Each dose will be administered with 240 mL water."
15892543|NCT03708133|Drug|Nifurtimox (Lampit, BAYA2502)_Test|Orally intake of 1 *120mg new formulation tablet as test treatment
15892544|NCT03708133|Drug|Nifurtimox (Lampit, BAYA2502)_Reference|Orally intake of 1 *120mg current clinical formulation tablet as reference treatment
15892545|NCT03708120|Other|Citrepel (Insect Repellent) EPA Reg. No. 84878-2|Citrepel (Insect Repellent) EPA Reg. No. 84878-2 is a pump spray formulation containing the active ingredient Citriodiol®, a tradename for Oil of Lemon Eucalyptus (OLE, Chemical Abstracts Service (CAS) No.: 1245629-80-4). Citriodiol® is derived from Eucalyptus citriodora leaves and contains a minimum of 65% p-Menthane-3,8-diol (PMD, CAS: 42822-86-6) and other constituents occurring naturally in the essential oil source material. The repellent is manufactured by Citrefine International Ltd and will be supplied by them in the pump spray bottle the manufacturer intends to use when the product is marketed with instructions for use on the product label.
15892546|NCT03708107|Device|MEP|MEP® will be applied with an acupuncture needle (0,30 x 25 mm). The needle will be introduced perpendicularly to the MTrP with 100 uA and then increased up to 600 uA. The current will be paused if the patient feels a burning sensation, pain or oppression, waiting up to the patient feels no discomfort. The procedure will be repeated as many times is necessary until the patient do not feel any discomfort for more than 1 minute.
15892547|NCT03708107|Other|Ischemic compression|Ischemic compression will be applied perpendicularly to the MTrP, increasing gradually the pression until the patient refers the maximum tolerable pain. This pressure will be applied for 1 minute.
15892548|NCT03708094|Diagnostic Test|molecular diagnosis|whole exome sequencing and data analysis to elucidating molecular diagnosis
15892549|NCT03708081|Procedure|ProTaper Next|Root canal instrument
15892550|NCT03708081|Procedure|TF Adaptive|Root canal instrument
15892551|NCT03708068|Other|Early exclusive enteral nutrition|Infants will be fed at least 80% of reference daily fluid intake from day one. Feeds will be advanced by 20-30 ml/kg per day on second day onwards to meet reference daily fluid intake until infant reaches full enteral feed.
15892552|NCT03708055|Behavioral|Exercise Intervention|Undergo weight bearing exercise program
15892553|NCT03708042|Combination Product|Definitive Radiochemotherapy|Radiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day
15892554|NCT03708042|Combination Product|Neoadjuvant Radiochemotherapy|Concurrent Radiochemotherapy: Radiotherapy,IMRT, 40Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day; Receive radical surgery 4 to 6 weeks later.
15892555|NCT03708029|Other|Revita Allograft|Human placental allograft
15892556|NCT03708016|Device|Robot gait training|Lokomat robot training was applied to stroke patients.
15892557|NCT03708016|Device|Brain stimulation|tDCS brain stimulation on leg motor areas was applied to stroke patients.
15892558|NCT03708003|Drug|Ibrutinib|"Patients receive 6 cycles (cycle = 28 days) of ibrutinib monotherapy at the daily dose of 420 mg (3x 140 mg).
~Venetoclax is added on ibrutinib treatment starting from cycle 7 as weekly dose ramp-up (20 mg, C7 day 1-7; 50 mg, C7 day 8-14; 100 mg, C7 day 15-21; 200 mg, C7 day 22-28; 400 mg, C8-31 day 1-28).
~Venetoclax (400 mg d1-28) and ibrutinib (420 mg d1-28) continue until cycle 31. Depending on MRD-neg CR/CRi patients will continue the combination treatment (maintenance) or stop treatment (observation) up to 5 years after cycle 31."
15892559|NCT03708003|Drug|Venetoclax|"Venetoclax is added on ibrutinib treatment starting from cycle 7 as weekly dose ramp-up (20 mg, C7 day 1-7; 50 mg, C7 day 8-14; 100 mg, C7 day 15-21; 200 mg, C7 day 22-28; 400 mg, C8-31 day 1-28).
~Venetoclax (400 mg d1-28) and ibrutinib (420 mg d1-28) continue until cycle 31. Depending on MRD-neg CR/CRi patients will continue the combination treatment (maintenance) or stop treatment (observation) up to 5 years after cycle 31."
15892560|NCT03707990|Drug|NNC0165-1875|Participants will receive a single dose of subcutaneous (s.c.) NNC0165-1875 injection. The planned doses of NNC0165-1875 are as following: cohort 1 and 7: 0.1 mg, cohort 2 and 8: 0.3 mg, cohort 3 and 9: 0.6 mg, cohort 4 and 10: 1.2 mg, cohort 5 and 11: 2.4 mg and cohort 6: 0.03 mg.
15892561|NCT03707990|Drug|Placebo (NNC0165-1875)|Participants will receive a single dose of s.c. placebo injection.
15892562|NCT03707990|Drug|Semaglutide|Participants will receive a single dose of s.c. semaglutide 0.25 mg injection.
15892563|NCT03707977|Drug|ART|ART will not be provided by the study. Participants will continue to receive their ART regimen they were receiving prior to enrolling in the study.
15892564|NCT03707977|Biological|VRC01LS|Administered by intravenous (IV) infusion
15892565|NCT03707977|Biological|10-1074|Administered by intravenous (IV) infusion
15892566|NCT03707964|Other|Crisis Resource Management Skill Training|Focused crisis resource management training which targets at the cognitive skills needed to monitor and challenge a superior's decision.
15892567|NCT03707964|Other|Standard ACLS Training|Standard didactic interactive session on Advanced Cardiac Life Support (ACLS) principles.
15892568|NCT03707951|Drug|N-acetylcysteine|N-acetylcysteine 1200 mg twice daily for 8 weeks (administered orally)
15892569|NCT03707951|Drug|Placebo oral capsule|Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks (administered orally)
15892570|NCT03707938|Drug|Brigatinib|Given PO
15892571|NCT03707938|Procedure|Local Consolidation Therapy|Undergo local consolidative therapy
15892575|NCT03707912|Drug|Anaferon|Oral administration.
15892576|NCT03707912|Drug|Placebo|Oral administration.
15892577|NCT03707899|Drug|JLP-1401|Administration of JLP-1401(Telmisartan/Amlodipine/Rosuvastatin)
15892578|NCT03707899|Drug|Telmisartan/Amlodipine, Rosuvastatin|Administration of Temlisartan/Amlosipine(Twinsta®) and Rosuvastatin(Crestor®)
15892579|NCT03707886|Behavioral|Pain SMART|Pain SMART is a brief, one-visit shared medical appointment where providers in primary care and a behavioral health specialist (e.g., a psychologist) meet with a group of patients with chronic pain to discuss pain management approaches.
15892580|NCT03707886|Other|minimally enhanced usual care|The minimally enhanced usual care group will receive educational information via mail about non-pharmacological approaches to pain management.
15892581|NCT03707873|Other|Education|Education + Medication adherence monitoring + Feedback when low adherence
15892582|NCT03707847|Drug|Crizotinib|250mg, BID, PO
15892583|NCT03707847|Drug|Etoposide Capsule|50mg, QD, PO, d1-10，21days for one cycle
15892584|NCT03707847|Procedure|Auto-HSCT|Auto-HSCT will be performed with patients who have achieved CR or VGPR.
15892585|NCT03707834|Behavioral|Antenatal Obesity Treatment (AO)|Participants in the treatment (AO) arm will receive a 4-component intervention: 1)Behavior change goals; 2)Self-monitoring; 3)Tailored skills training; and 4)WIC provider counseling Both treatment and usual care arms will receive the current standard of care offered to postpartum mothers at WIC.
15892586|NCT03707821|Device|senofilcon A TEST Lens|JJVC Investigational Contact Lens
15892587|NCT03707821|Device|senofilcon A CONTROL Lens|Acuvue Oasys
15892588|NCT03707808|Drug|intratumoral injection of autologous CD1c (BDCA-1)+ myDC|intratumoral injections plus intravenous administration
15892589|NCT03707795|Drug|Betamethasone sodium phosphate/betamethasone acetate (Celestone® Soluspan®), 30 mg IM once a day for four days|Participants will be given four IM injections throughout the study
15892590|NCT03707769|Device|TIPS microspheres|TIPS microspheres manufactured from GMP grade poly(lactide-co-glycolide) (PLGA) prepared as a paste with GranuGel.
15892591|NCT03707730|Dietary Supplement|AGY|oral AGY taken prior to meals
15892592|NCT03707730|Other|placebo|oral placebo taken prior to meals
15892593|NCT03707717|Drug|Bimekizumab|Subjects will receive a pre-specified sequence of bimekzumab in the Treatment Period.
15892594|NCT03707691|Behavioral|Listening tests. Pitch training protocol|The two training protocols consists of perceptual tasks (auditory or visual exercises) performed repetitively using a tablet. Each protocol consists in 30 sessions of ~20 minutes performed at home over a period of 15 weeks.
15892595|NCT03707691|Behavioral|visuo-spatial training protocol|The two training protocols consists of perceptual tasks (auditory or visual exercises) performed repetitively using a tablet. Each protocol consists in 30 sessions of ~20 minutes performed at home over a period of 15 weeks.
15892596|NCT03707691|Behavioral|EEG/MEG/MRI recordings.|Listening tests. EEG/MEG/MRI recordings
15892597|NCT03707678|Drug|GSK2245035|GSK2245035 will be administered weekly once as a nasal spray solution with dosing strength of 10 ng per actuation. GSK2245035 will be available as a saline formulation, preserved with benzalkonium chloride and disodium edetate in an amber glass bottle fitted with a screw-fit atomizing pump.
15892598|NCT03707678|Drug|Placebo|Placebo will be administered weekly once as a nasal spray solution. Placebo will be available as a saline formulation, preserved with benzalkonium chloride and disodium edetate in an amber glass bottle fitted with a screw-fit atomizing pump.
15892599|NCT03707678|Drug|FP-DPI|FP will be administered using Diskus inhaler with dosing strengths of 500, 250, 100, 50 µg twice daily per actuation.
15892600|NCT03707678|Drug|Albuterol/Salbutamol|Albuterol/Salbutamol MDI will be administered for symptom relief from screening to the end of the study.
15892601|NCT03707678|Other|eDairy|Subjects will record all the alerts indicative of worsening of asthma in eDairy.
15892602|NCT03707678|Other|ACQ-6|ACQ-6 will include six questions which enquire about the frequency and/or severity of symptoms. The response options for all these questions consist of a zero (no impairment/limitation) to six (total impairment/limitation) scale.
15892603|NCT03707665|Diagnostic Test|Compression ultrasound testing|Compression ultrasound testing, screening technique for diagnosing deep venous thrombosis
15892604|NCT03707652|Dietary Supplement|Oral supplement A|1, 2 or 4 capsules daily of oral supplement A for 3 days
15892605|NCT03707652|Dietary Supplement|Oral supplement B|4 capsules daily of oral supplement B for 3 days
15892606|NCT03707652|Dietary Supplement|Oral supplement C|1,2 or 4 capsules daily of oral supplement C for 3 days
15892607|NCT03707652|Dietary Supplement|Oral supplement D|1 or 2 tablets daily of oral supplement D for 3 days
15892608|NCT03707652|Dietary Supplement|Oral Supplement D in combination with oral supplement C|1 or 2 tablets of oral supplement D in combination with 2 or 4 capsules of oral supplement C for 3 days
15892609|NCT03707639|Drug|Apatinib|Apatinib (500 mg qd p.o.) until disease progression or intolerable toxicity or refused by the patients.
15892610|NCT03707639|Drug|POF|The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days.
15892611|NCT03707626|Other|Wellens Sign|presence or absence in presence of coronary collaterals to LAD
15892612|NCT03707613|Procedure|DWT learning curve|trainees learn to perform DWT after unsuccessful initial cannulation
15892613|NCT03707600|Device|TMS|MagVenture MagPro 100 with MagOption (MagVenture Inc, Alpharetta, GA) machine equipped with a figure-8 coil.
15892616|NCT03707561|Diagnostic Test|Right Heart Catheterization (RHC)|RHC at the enrollment and every 12 months
15892617|NCT03707548|Behavioral|BPT|BPT will consist of 6 weekly group sessions, based on a scientific approach, integrating body-oriented techniques to improve patients' awareness, perception, acceptance, and expression regarding their body.
15892618|NCT03707548|Behavioral|Smartphone-triggered bodily interventions|Smartphone-triggered bodily interventions will consist of brief BPT exercises insuring the transfer from the group BPT sessions into patients' daily lives. Smartphone bodily interventions will be triggered by short audio-clips.
15892619|NCT03707548|Behavioral|Smartphone triggered control intervention|The smartphone triggered control intervention will be selected fairy tales presented by audio-clips.
15892620|NCT03707535|Biological|CT-P13|3 mg/kg, 2-hour infusion per dose co-administered with methotrexate and folic acid
15892621|NCT03707535|Biological|Remicade|3 mg/kg, 2-hour infusion per dose co-administered with methotrexate and folic acid
15892622|NCT03707522|Behavioral|Growth mindset|10 minute interactive article describing neuroplasticity
15892623|NCT03707522|Behavioral|Modifiable risk factor (MRF) information|10 minute interactive article describing modifiable risk factors for depression and anxiety
15892624|NCT03707522|Behavioral|Control|10 minute interactive article describing activity scheduling
15892625|NCT03707509|Drug|Camrelizumab|Maximum 6 cycles for combined therapy. Camrelizumab maintenance.
15892626|NCT03707509|Drug|Placebos|Maximum 6 cycles for combined therapy.
15892627|NCT03707509|Drug|Gemcitabine|Maximum 6 cycles for combined therapy.
15892628|NCT03707509|Drug|Cisplatin|Maximum 6 cycles for combined therapy.
15892629|NCT03707483|Combination Product|combination of vitamin C and platelet rich fibrin|combination of vitamin C and platelet rich fibrin
15892630|NCT03707470|Device|Custom fitted compression garments (CF)|Custom fitted compression garments (Isobar, Manchester, UK) designed to provide 35 mmHg at the ankle and >20 mmHg at the mid-thigh (equivalent to European class 2 compression garments)
15892631|NCT03707470|Device|Standard-sized compression garments (SSG)|Off-the-shelf, standard-sized garments (2XU, Campbelltown, Australia), typically providing pressures equivalent to European grade 1 compression or below (5 - 10 mmHg at both the ankle and thigh)
15892632|NCT03707470|Procedure|Sham ultrasound (CON)|Sham ultrasound using an unplugged machine. Sham treatment for 5 minutes on each of the thighs, calves and hamstrings
15892633|NCT03707457|Drug|Nivolumab|Patients receive nivolumab intravenously (IV) over 30 minutes on Day 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
15892634|NCT03707457|Drug|Anti-GITR Monoclonal Antibody MK-4166|Patients receive anti-GITR intravenously (IV) over 30 minutes on Day 1 of the first cycle of nivolumab after arm assignment. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
15892635|NCT03707457|Drug|IDO1 inhibitor INCB024360|Patients receive IDO1 inhibitor by mouth daily beginning on Day 1 of the first cycle of nivolumab after arm assignment. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
15892636|NCT03707457|Drug|Ipilimumab|Patients receive ipilimumab intravenously (IV) over 90 minutes on Day 1 of the first cycle of nivolumab after arm assignment. Courses repeat every 21 days for up to 4 doses in the absence of disease progression or unacceptable toxicity.
15892637|NCT03707444|Device|Scrambler Therapy Device|Superficial neuromodulation using EKG type electrodes [Scrambler (MC5-A Calmare) Therapy]
15892638|NCT03707431|Behavioral|Web-based CBT|The eight child modules include: 1) education about chronic pain, 2) recognizing stress and negative emotions, 3) deep breathing and relaxation, 4) implementing coping skills at school, 5) cognitive skills (e.g., reducing negative thoughts), 6) lifestyle interventions, 7) staying active (e.g., pleasant activity scheduling), 8) relapse prevention. The eight parent modules are: 1) education about chronic pain, 2) recognizing stress and negative emotions, 3) operant strategies I (using attention and praise to increase coping), 4) operant strategies II (using rewards to increase positive coping and reach school goals), 5) modeling, 6) lifestyle, 7) communication, 8) relapse prevention.
15892639|NCT03707431|Behavioral|Pain Education|The pain education website provides publicly available educational information about pancreatitis and abdominal pain. There is general information about pancreatitis from available web sources (e.g., National Pancreas Foundation) as well as information about chronic pain in childhood. The content does not include any instruction in the behavioral and cognitive skills taught within the WebMAP program.
15892640|NCT03707418|Drug|Heparin Sodium|Intravenous Heparin titrated to Partial ThromboplastinTime (PTT) levels
15892641|NCT03707418|Drug|Bivalirudin Injection [Angiomax]|Intravenous Bivalirudin titrated to Activated Clotting Time (ACT) levels
15892642|NCT03707405|Behavioral|Ride-On Cars Training with Different Postures|All programs will include 120 minutes/per session, 2 sessions/per week. All participants will continue their regular therapy during the whole study. The treatment strategy of ROC training with different postures will be based on the exploratory learning which focuses on providing opportunities to the participants to explore environmental properties with various motor patterns during the intervention.
15892643|NCT03707392|Other|Ostomy Education Video|Ostomy education video in addition to standard ostomy education including preoperative and postoperative ostomy nurse teaching and educational materials
15892644|NCT03707392|Other|Control - Standard ostomy education|Standard ostomy education including preoperative and postoperative ostomy nurse teaching and educational materials
15892645|NCT03707366|Behavioral|FHF-T|FHF-T employs mentoring, consisting of relationship development, advocating for and empowering youth, and skill-building activities to promote positive youth development. Mentors meet individually for 2-3 hours per week for 30 weeks with each teen they mentor, in order to engage teens in positive youth development activities and provide skills training in areas including emotion recognition, perspective-taking, problem solving, effective communication, managing anger, healthy coping and resisting peer pressure for deviant activities. Youth also attend group workshops over the course of the program, in which they engage with other participants and mentors in skill-building activities.
15892646|NCT03707353|Biological|ChAd63 ME-TRAP and MVA ME-TRAP vaccination|vaccination with ChAd63 ME-TRAP 5x10^10 vp (intramuscularly and intravenously) vaccination with MVA METRAP 2x10^8 pfu (intramuscularly) and MVA METRAP 2x10^7 pfu (intravenously) Group 5 will be challenged with malaria by mosquito bite.
15892647|NCT03707340|Drug|Flibanserin Pill|Eligible participants will begin treatment with flibanserin 100 mg orally daily at bedtime for 24 weeks.
15892648|NCT03707327|Other|Game Ready|the participants remained for 20 minutes with intermittent compression therapy + cryotherapy
15892649|NCT03707327|Other|Ice pack|the participants remained for 20 minutes with cryotherapy with ice pack
15892650|NCT03707314|Procedure|Angiography with follow-on revascularisation if indicated|Angiography with follow-on revascularisation (if indicated)
15892651|NCT03707301|Other|Questionnaires|Questionnaires of satisfaction and the Hospital Anxiety and Depression scale.
15892652|NCT03707288|Other|Spine Exercise Program|Spine exercises should be done 20 minutes/ 3 days per week Desk stretches should be done when exposed to prolonged sitting for greater than 60 mins
15892653|NCT03707275|Device|Alexa+|Patients will receive the Amazon Echo Dot with Alexa voice technology (Alexa+) and will be asked to interact with the device for 3 months. Alexa+ will ask a series of questions. Based on the answers to these questions, it will either contact a study coordinator or will ask patients to take a specific action (such as weighing themselves). Data from this simple intervention will be merged with data extracted from the patient's health record and analyzed for clinical variables and demographics that are most predictive for success in use of these technologies.
15892654|NCT03707275|Other|Standard of Care Arm|This group will receive standard of care (SOC) HF management, which will entail regular follow up from the HF nurse and data from all hospital or clinic visits will be captured from the EHR.
15892655|NCT03707262|Biological|Donor CD34+ and CD3+ cells|Infusion of GCSF-mobilized, Miltenyi-enriched CD34+ hematopoietic stem/progenitor cells (HSPCs) (≥ 5 million cells/kg) and CD3+ cells (5 million cells/kg) from an HLA-identical sibling living donor, following pre-conditioning regimen of rATG and TLI.
15892656|NCT03707249|Drug|Ferric Carboxymaltose Injectable Product|iv iron infusion: 15 mg / kg up to a maximum 1g dose of Ferinject diluted in normal saline (0.9%) up to a total volume of 250 ml
15892657|NCT03707249|Drug|Normal Saline 0.9% Infusion Solution Bag|250 ml of normal (0.9%) saline given by intravenous infusion over 20 minutes. This constitutes the control for the iron infusion.
15892658|NCT03707236|Behavioral|Teledermatology visits|Patients in the treatment arm will be taught by study staff how to take the standardized photos of themselves at treatment week 4 (prior to initiation of teledermatology visits). For patients in the treatment arm, the teledermatology visits will be managed by the study staff. A monthly teledermatology visit will consist of sending facial and truncal (if affected) clinical images to a the study staff using Patient Gateway. Once this is completed, the patient and a member of the study staff will have a scheduled telephone appointment during which the provider will screen for any adverse events and will provide counseling as outlined in iPledge guidelines. The patient will also be asked to verbally complete a monthly survey assessing acne severity, quality of life, cost attributable to the appointment, time missed from school/work, satisfaction with treatment. All photographs will be uploaded in LMR/EPIC in the patient's medical record.
15892659|NCT03707223|Behavioral|The Interfaces Program|career development program
15892660|NCT03707223|Behavioral|IPS|supported employment using the individual placement and support (IPS) model
15892661|NCT03707210|Behavioral|VR training program|Use VR software to make a training education program.
15892662|NCT03707197|Behavioral|Meditation|Ten minutes of meditation per day for 8 weeks using a mobile application
15892663|NCT03707184|Procedure|Computed Tomography|Undergo PET/CT scan
15892664|NCT03707184|Drug|Fluciclovine F18|Given IV
15892665|NCT03707184|Procedure|Positron Emission Tomography|Undergo PET/CT scan
15892666|NCT03707171|Drug|Liraglutide|Liraglutide is a glucagon-like peptide type 1 (GLP-1) analogue. It has been proved that Liraglutide can improve insulin resistance and cognitive function in AD animals. Therefore, it is speculated that Liraglutide may interfere with the occurrence and development of cognitive dysfunction in patients with T2DM. In order to confirm the effects, the investigators conduct an open, prospective, positive controlled study in patients with T2DM.
15892667|NCT03707171|Drug|placebo|Any hypoglycemic drugs except glucagon-like peptide type 1 (GLP-1) analogue.
15892668|NCT03707158|Behavioral|Therapist-led Face-to-Face Cognitive-Behavioral Therapy|Participants receiving face-to-face cognitive-behavioral therapy will participate in therapist-led, office-based or telehealth CBT treatment for up to 16 weeks. Sessions focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
15892669|NCT03707158|Behavioral|Digital Cognitive-Behavioral Therapy|Participants receiving digital cognitive-behavioral therapy will complete an online, largely self-administered CBT program for up to 16 weeks with 8 modules and adjunctive therapist phone support. Treatment modules focus on psychoeducation about anxiety, thought challenging and cognitive restructuring, somatic management skills training, youth exposure to feared stimuli, family patterns associated with the maintenance of youth anxiety, and contingent reinforcement.
15892670|NCT03707145|Behavioral|Consultation|The consultation will provide advice (including a short written report) about promoting healthy lifestyles, tailored to the individual
15892671|NCT03707145|Behavioral|Online Support|The participant will have access to an online platform 'FACET', to monitor themselves periodically, obtain feedback about their functional ability, receive recommended diet, exercise and physical activity interventions and record the adherence to any intervention.
15892782|NCT03706300|Drug|Guaifenesin and Pseudoephedrine Hydrochloride Extended Release Tablets 1200/120 mg|
15892672|NCT03707145|Behavioral|Empowered|The participant will be actively encouraged to contribute to their own consultation and take co-ownership and responsibility for the action plan.
15892673|NCT03707132|Procedure|Tourniquet: Folley catheter in the low segment of the uterus|
15892674|NCT03707119|Other|Educational programme|the health professional students were undergone to Student 4 Best Evidence blog, as a specific educational programme to learn EBP competencies.
15892675|NCT03707106|Behavioral|CBT smoking cessation|an established protocol for smoking cessation based on cognitive behavioral therapy
15892676|NCT03707106|Behavioral|virtual reality based cue exposure|smoking cue exposure in virtual reality
15892677|NCT03707106|Behavioral|progressive muscle relaxation|Progressive muscle relaxation for unspecific stress reduction
15892678|NCT03707093|Drug|ADG106|IV infusion over 60 minutes on Day 1 of each cycle, at doses of 0.03 mg/kg, 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, or 10 mg/kg depending on cohort at enrollment.
15892679|NCT03707067|Device|Compression garments|Made-to-measure compression garments providing high pressures (> 30 mmHg at the ankle and >20 mmHg at the thigh - equivalent to European class-2 stockings)
15892680|NCT03707067|Other|Sham recovery drink|"Non-caloric beverage, labelled as a recovery drink proposed to enhance athletic recovery. Aspartame/acesulfame-k based sweetener, providing 0.5 g carbohydrate and 2 Kcal per serving"
15892681|NCT03707054|Diagnostic Test|Study Arm|Measurements of optic nerve diameter, serum and urine osmolarity, serum vasopressin
15892682|NCT03707041|Drug|P218 (1000 mg) Oral Capsules|1000 mg P218 (4 x 250 mg capsules)
15892683|NCT03707041|Drug|Placebo Oral Capsules|Placebo capsules matched to the P218 capsules with regard to appearance and taste
15892684|NCT03707041|Drug|P218 (100 mg) Oral Capsules|100 mg P218 (2 x 50 mg capsules)
15892685|NCT03707041|Biological|PfSPZ Challenge|3200 P. falciparum Sporozoites by direct venous inoculation (DVI)
15892686|NCT03707028|Drug|Rivoceranib|Oral daily doses of rivoceranib (as its mesylate salt)
15892687|NCT03707028|Drug|Paclitaxel|Fixed dose of paclitaxel given intravenously on day 1, day 8, and day 15
15892688|NCT03707002|Dietary Supplement|scFOS|daily intake for 6 weeks
15892689|NCT03707002|Dietary Supplement|Maltodextrin|daily intake for 6 weeks
15892690|NCT03706989|Procedure|EEG|EEG samples will be recorded before and during the cardiac surgery in order to perform spectral and coherence analyses
15892691|NCT03706989|Genetic|Apolipoprotein genotype|APOE genotyping will be performed for each patient
15892692|NCT03706989|Biological|Serum NfL measurements|5 perioperative blood samples will be taken to measure the evolution of NfL in the serum (before and until postoperative day 5)
15892693|NCT03706989|Other|Preoperative neurocognitive evaluation|Each patient will benefit from a complete neurocognitive evaluation before surgery (battery of validated cognitive tests)
15892694|NCT03706976|Device|Tissue Oxygenation Monitoring|The NIRS sensor will be applied to the abdomen of the study population. To ensure good skin contact the sensor will be placed underneath the diaper. If that should not provide enough measurement stability, additional fixation will be given by employing aforementioned flexible bandage routinely employed in neonatal care. Once good skin contact is ensured, the sensor will measure aStO2 for up to seventy-two hours. The presence of this sensor will not disturb daily clinical activities or medical treatment in any way. Should good skin contact be endangered by movements, clinical interactions or such, the sensor will be removed and re-attached to the infants' abdomen as a consequence.
15892696|NCT03706950|Drug|Elpida® + 2 NRTIs|Elpida® 20mg qd orally + 2 NRTIs standard prescribed ART therapy
15892697|NCT03706937|Other|Semi directive interview|Semi directive interview will be performed to try to define the management of addictions in the oncology care course. Thus, an approach in terms of social representations among paramedical professional actors involved in the care of patients treated for cancer and with an unresolved addictive disorder sounds the best way for this research.
15892698|NCT03706924|Drug|VM-1500FDC|A fixed-dose combination of three active substances: tenofovir 300 mg + elsulfavirine 20 mg + emtricitabine 200 mg, film-coated tablets
15892699|NCT03706924|Drug|Elpida®|Elpida®, capsules, elsulfavirine 20 mg
15892700|NCT03706924|Drug|Truvada®|Truvada® (tenofovir 300 mg / emtricitabine 200 mg), film-coated tablets
15892701|NCT03706911|Drug|VM-1500A-LAI|VM1500A (parent drug of elsulfavirine) IM injection dosage form
15892702|NCT03706898|Drug|Elpida®|Elpida® capsules, 20mg
15892703|NCT03706898|Drug|Dolutegravir|Dolutegravir, film-coated tablets, 50mg
15892704|NCT03706898|Drug|Sofosbuvir|Sofosbuvir, film-coated tablets, 400mg
15892705|NCT03706898|Drug|Daclatasvir|Daclatasvir, film-coated tablets, 60mg
15892706|NCT03706885|Drug|Sustiva Pill|One pill (Sustiva 50 mg or Sustiva 200mg or Placebo) One pill per day for 20 weeks
15892707|NCT03706872|Other|Intervention group|The provision of an App for monitoring physical activity and weight with a smart watch and the administration of virtual advice through messages with mobile phone and the midwife's feedback, as well as the provision of usual prenatal care
15892708|NCT03706859|Procedure|Pneumatic tourniquet inflation pressure|Pneumatic tourniquet inflation pressure estimation using two different mathematical equations
15892709|NCT03706846|Procedure|fasting|fasting before gastrointestinal endoscopy
15892710|NCT03706833|Device|Edwards PASCAL System|Transcatheter mitral valve repair with the Edwards PASCAL System
15892711|NCT03706833|Device|Abbott Mitraclip System|Transcatheter mitral valve repair with the Abbott Mitraclip System
15892712|NCT03706807|Other|Mindfulness-Based Intervention|This intervention is a meditative practice which the individuals will practive in their daily life following the MBHP protocol
15892713|NCT03706807|Other|Cognitive Stimulation|A basic computer workshop in order to develop the psychomotricity involving the use of mouse, keyboard, MS paint, photo gallery and PowerPoint presentations to surf on the internet, learn how to play online games and use social networks
15892714|NCT03706794|Behavioral|Clinical Decision Support Tool|Tailored education provided via a smartphone application.
15892715|NCT03706794|Behavioral|Headache Education|Non-tailored education provided via a smartphone application.
15892826|NCT03705923|Procedure|Bariatric surgery|laparoscopic Roux-en-Y gastric bypass or laparoscopic sleeve gastrectomy
15907907|NCT03588390|Drug|Placebo|Placebo to middle strength tablet
15892716|NCT03706781|Drug|Cetylpyridinium Chloride 0.05% + Benzydamine HCl 0.15% + mucus adhesive polymer|Test product will be applied twice a day (b.i.d) every 12 h once in the morning and once in the evening for 6 consecutive days (from Day 1 to Day 6) and once in the morning on Day 7 for a total of 13 dose
15892717|NCT03706781|Drug|Cetylpyridinium Chloride 0.05% + Benzydamine HCl 0.15%|Reference Product will be applied twice a day (b.i.d) every 12 h once in the morning and once in the evening for 6 consecutive days (from Day 1 to Day 6) and once in the morning on Day 7 for a total of 13 dose
15892718|NCT03706768|Other|Glycocalyx|Measure Degradation of the Glycocalyx
15892719|NCT03706755|Drug|Norepinephrine: 1mcg/kg|intervention:Parturients will receive Norepinephrine: a bolus of 1 mcg/Kg immediately after SA (preventive bolus) then they will receive complementary doses of Norepinephrine (half dose: 0.5 mcg/Kg) to maintain systolic blood pressure above 80 % of baseline
15892720|NCT03706755|Drug|Norepinephrine 0,5mcg/kg|intervention: Parturients will receive Norepinephrine: a bolus of 0.5 mcg/Kg immediately after SA (preventive bolus) then they will receive complementary doses of Norepinephrine (half dose: 0.25 mcg/Kg) to maintain systolic blood pressure above 80 % of baseline
15892721|NCT03706742|Behavioral|Mailed outreach|The investigators will randomize all baby boomer patients (~12,000 patients) using a centrally maintained computer-generated list. Patients will be randomly assigned to one of two HCV screening strategies including: visit-based screening as part of usual care (Group 1) or mailed screening invitation outreach and centralized patient navigation (Group 2).
15892722|NCT03706729|Device|Spraino|"Spraino® is an adhesive polytetrafluoroethylene (PTFE or Teflon) patch developed with the purpose of minimizing lateral shoe-surface friction whenever initial contact is carried out in an inverted position of the ankle joint. Each Spraino® PTFE patch has a minimum durability of 20 hours use and will be provided by the study sponsor, Spraino® ApS. The participants will receive four pairs of Spraino® upon their enrollment to the study."
15892723|NCT03706716|Other|decision aid developed for pelvic organ prolapse|Conversation based upon the inter face in the Electronic patient journal.
15892724|NCT03706703|Drug|Endostar|continuous intravenous infusion Endostar,7.5mg/m2, continuous intravenous infusion for 14 days each cycle, 21 days as one cycle, 4 cycles in total.
15892725|NCT03706703|Drug|Docetaxel|docetaxel is 75 mg/m2 intravenously over 1 hour on Day 1 of each 21-day cycle
15892726|NCT03706703|Drug|Carboplatin|carboplatin is administered on Day 1 of each 21-day，followed by docetaxol or pemetrexed
15892727|NCT03706703|Drug|Pemetrexed|pemetrexed is 500 mg/m2 intravenously on Days 1 of each 21-day cycle
15892728|NCT03706690|Drug|Durvalumab|Durvalumab 1500 mg every 4 weeks [q4w] intravenously [iv] until clinical progression/ deterioration or confirmed radiological progression.
15892729|NCT03706690|Other|Placebo|Matching placebo for infusion every 4 weeks iv until clinical progression/deterioration or confirmed radiological progression
15892730|NCT03706677|Device|Cryoballoon (Arctic Front Advance Cryoballoon)|Ablation using a Cryoballoon catheter (Arctic Front Advance Cryoballoon Cardiac Ablation Catheter)
15892731|NCT03706677|Device|Radiofrequency Catheter (ThermoCool Smarttouch)|Ablation using a Radiofrequency ablation catheter (ThermoCool Smarttouch catheter)
15892732|NCT03706664|Other|Machine learning algorithm|Study will develop and test a machine learning algorithm using MR Enterography images labelled by Radiologists.
15892733|NCT03706651|Device|Infants hospitalized in health facilities performing Tele-expertise|
15892734|NCT03706638|Dietary Supplement|Ferrous Sulfate|Patients would be randomized to either taking ferrous sulfate daily or every other day (on non consecutive days).
15892735|NCT03706599|Behavioral|Therapeutic education on fever|Session for therapeutique education on fever
15892736|NCT03706599|Behavioral|Therapeutic education on household accidents|Session for therapeutic education on household accidents
15892737|NCT03706586|Procedure|30% group|Infants in the 30 % group will remain in 30% oxygen (O2) until 5 min of age. At 5 min of age, the clinical team will assess oxygen saturation (SpO2). If SpO2 is <85%, O2 should be increased by 10-20% every 60 sec to achieve SpO2 of 85% or greater or a SpO2 of 90-95% at 10 min of age. If SpO2 are greater than 95% at or before 5 min of age, O2 should be decreased stepwise (every 60 sec) with an aim to maintain SpO2 of 85% or greater during 5-10 min of age or 90-95% at and beyond 10 min of age.
15892738|NCT03706586|Procedure|60% group|Infants in the 60 % group will remain in 60% oxygen (O2) until 5 min of age. At 5 min of age, the clinical team will assess oxygen saturation (SpO2). If SpO2 is <85%, O2 should be increased by 10-20% every 60 sec to achieve SpO2 of 85% or greater or a SpO2 of 90-95% at 10 min of age. If SpO2 are greater than 95% at or before 5 min of age, O2 should be decreased stepwise (every 60 sec) with an aim to maintain SpO2 of 85% or greater during 5-10 min of age or 90-95% at and beyond 10 min of age.
15892739|NCT03706573|Drug|alpelisib|50 mg and 200 mg film coated tablets administered orally once daily. Starting dose is 350 mg daily. Starting dose as a combination agent with endocrine partner is 300mg daily.
15892740|NCT03706547|Biological|anti-CD19/BCMA CAR-T cells|Retroviral vector-transduced autologous T cells to express anti-CD19 and anti-BCMA CARs
15892741|NCT03706547|Drug|Fludarabine|30mg/m2/d
15892742|NCT03706547|Drug|Cyclophosphamide|300mg/m2/d
15892743|NCT03706534|Device|Ultrasound Image review with CADe|This software is a computer-aided detection (CADe) software application, designed to assist radiologist to analyze breast ultrasound images. S-Detect automatically segments and classifies shape, orientation, margin, lesion boundary, echo pattern, and posterior feature characteristics of user-selected region of interest. The device uses deep learning methods to perform tissue segmentation and classification of images.
15892744|NCT03706534|Device|Ultrasound Image review with CADx|This software is also a computer-assisted diagnostic(CADx) software application, designed to assist a medical doctor in determining diagnosis by presenting whether a lesion is malignant in a breast ultrasound image obtained from an ultrasound imaging device.
15892745|NCT03706534|Device|Ultrasound Image manual review|The images will be reviewed by the radiologists using BIRADS scheme without any assistance of artificial assistance. This review will be done off-line using a separate program in entirely manual mode. During this review, BIRADS descriptor choices by each radiologist and the time it takes for the radiologist to make such decision will be stored.
15892783|NCT03706287|Drug|anlotinib 8mg + AP/PC|anlotinib 8mg/d, q.d., p.o. 1-14days every 21 days Pemetrexed(A) 500mg/m2, IV, Day 1; Cisplatin(P) 25mg/m2,IV,Day 1-3 or Carboplatin(C) area under curve(AUC)=5, IV, Day 1; AP or AC will be administered every 21 days starting on Day 1.
15892746|NCT03706534|Procedure|Biopsy|Suspicious lesions found on breast ultrasound are then followed either by ultrasound guided biopsy or ultrasound imaging every 6 months for two years. For those who undergo biopsy, ultrasound provides images which are used to localize the lesion and guide the placement of the biopsy needle. The sample is sent to pathology for diagnosis, while the ultrasound guidance images are stored. For those who have imaging follow-up, ultrasound images of the breast mass are obtained, digitally stored and interpreted by the radiologist typically using BIRADS scheme.
15892747|NCT03706521|Drug|SM04690|Healthcare professional-administered intra-articular injection performed once on Day 1 of the study.
15892748|NCT03706508|Procedure|Robot-assisted laparoscopic radical prostatectomy|Patients with localized prostate cancer underwent transperitoneal robot-assisted laparoscopic radical prostatectomy
15892749|NCT03706495|Behavioral|The Group I Postural Exercise|Spine anatomy and daily life activities will be informed about proper posture. Strengthening of postural muscles, stretching (Pectoral Region, M. Psoas Major) and breathing exercise will be performed under the supervision of a physiotherapist. The Group I will receive postural exercise for 60 min/day 2 times/week for 8 weeks.
15892750|NCT03706495|Behavioral|The Group II Three-dimensional Exercise Therapy Program|The Group II Schroth method corrects the kyphotic posture, with the help of proprioceptive and exteroceptive stimulation and mirror control in the sagittal plane, using specific corrective breathing patterns. The Schroth method three-dimensional exercise therapy program adapted for the specific posture will be exercised in four specific positions (sitting, supine, standing, prone) under the supervision of a physiotherapist. Exercise include, trunk elongation, symmetrical sagittal straightening, shoulder traction, corrective breathing and muscle activation by increasing tension (isometric tension). The Group II will receive Schroth's three-dimensional exercise therapy program for 60 min/day 2 times/week for 8 weeks.
15892751|NCT03706482|Biological|BOOST cells|Four doses of expanded human 1st trimester fetal liver-derived mesenchymal stem cells.
15892752|NCT03706469|Drug|TAK-831 T2|TAK-831 T2 Tablets.
15892753|NCT03706469|Drug|TAK-831 T3|TAK-831 T3 Tablets.
15892754|NCT03706456|Biological|Darvadstrocel|Darvadstrocel cell suspension for intralesional injection.
15892755|NCT03706443|Other|Systane Complete|Lubricant eye drop which is based on propylene glycol 0.6%. Used for temporary relief of burning and irritation due to dryness of the eye.
15892756|NCT03706443|Other|Systane Ultra|Lubricant eye drop which is based on polyethylene glycol 400 0.4% and propylene glycol 0.3%. Used for temporary relief of burning and irritation due to dryness of the eye.
15892757|NCT03706417|Diagnostic Test|Telemedicine consult|Utilizing telemedicine in community hospital for earlier identification of symptoms of neonatal encephalopathy.
15892758|NCT03706404|Diagnostic Test|Point-of-Care ultrasound and testing|Point-of-Care ultrasound + Point-of-Care blood gas testing
15892759|NCT03706378|Other|Glucose Reference 1|Glucose contains 50g of available carbohydrates
15892760|NCT03706378|Other|Glucose Reference 2|Glucose contains 50g of available carbohydrates
15892761|NCT03706378|Other|Glucose Reference 3|Glucose contains 50g of available carbohydrates
15892762|NCT03706378|Other|Wheat Yellow Noodle|Wheat Yellow Noodle will contain 50g of available carbohydrate
15892763|NCT03706378|Other|Beta-glucan yellow Noodle|Beta-glucan yellow noodle will contain 50g of available carbohydrate
15892764|NCT03706378|Other|Rice Roll|Rice Roll will contain 50g of available carbohydrate
15892765|NCT03706378|Other|Rice Roll with resistant starch|Rice Roll fortified with resistant starch will contain 50g of available carbohydrate
15892766|NCT03706378|Other|Sucrose Jelly|Jelly and bread will contain 50g of available carbohydrate. The jelly will contain 25g of sucrose
15892767|NCT03706378|Other|Isomaltulose Jelly|Jelly and bread will contain 50g of available carbohydrate. The jelly will contain 25g of Isomaltulose
15892772|NCT03706352|Procedure|tunneling epidural catheter|The epidural needle was used to horizontally tunnel the catheter for a length of five centimeters on either side of the insertion point.
15892773|NCT03706339|Other|normal saline arm group|110 ml normal saline IV just before skin incision plus topical application of 120 ml normal saline applied on the placental bed during Cesarean section
15892774|NCT03706339|Drug|intravenous tranexamic acid|1 gm tranexamic acid (2 ampoules of Capron 500 mg /5 ml; Cairo, Egypt) intravenous just before skin incision plus110 ml normal saline IV just before skin incision plus topical application of 120 ml normal saline applied on the pelvic bed during cesarean section
15892775|NCT03706339|Drug|Topical tranexamic acid|2 gm topical tranexamic acid ( 4 ampoules of Capron 500 mg/5 ml applied typically) in 120 ml normal saline applied on the pelvic bed during cesarean section plus110 ml normal saline IV just before skin incision
15892776|NCT03706326|Biological|Anti-MUC1 CAR-T cells|Using the T cells from the patients' blood to produce anti-MUC1 CAR-T Cells and then the cells will be infused back to the patients.
15892777|NCT03706326|Biological|PD-1 knockout Engineered T cells|Using the T cells from the blood of the patients to prepare PD-1 knockout T cells, then the cells will be infused back to the patients.
15892778|NCT03706326|Combination Product|CAR-T combined with PD-1 Knockout T cells|Using the T cells from the blood of the patients to prepare anti-MUC1 CAR-T Cells and PD-1 knockout T cells, then the cells will be infused back to the patients
15892779|NCT03706313|Drug|15mL 0.25% bupivacaine|Patients will be randomly assigned to either a genicular nerve block with bupivacaine or saline
15892780|NCT03706313|Procedure|Genicular nerve block|"The ultrasound-guided genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler will be used to identify the arterial structures which serve as landmarks for the corresponding nerves.
~After skin local anesthetic infiltration, a 10 cm 21G insulated block needle will be inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle is confirmed, 5mL of a solution containing 15 ml of 0.25% bupivacaine with 2mg dexamethasone or 5mL saline will be slowly injected. Spread of local anesthetic will be documented adjacent to the target nerve. This procedure will be performed at the site of the three genicular nerves described."
15892781|NCT03706313|Drug|Saline|Patients will be randomly assigned to either a genicular nerve block with bupivacaine or saline
15892784|NCT03706287|Drug|anlotinib 10mg + AP/PC|anlotinib 10mg/d, q.d., p.o. 1-14days every 21 days Pemetrexed(A) 500mg/m2, IV, Day 1; Cisplatin(P) 25mg/m2,IV,Day 1-3 or Carboplatin(C) area under curve(AUC)=5, IV, Day 1; AP or AC will be administered every 21 days starting on Day 1.
15892785|NCT03706287|Drug|anlotinib 12mg + AP/PC|anlotinib 12mg/d, q.d., p.o. 1-14days every 21 days Pemetrexed(A) 500mg/m2, IV, Day 1; Cisplatin(P) 25mg/m2,IV,Day 1-3 or Carboplatin(C) area under curve(AUC)=5, IV, Day 1; AP or AC will be administered every 21 days starting on Day 1.
15892786|NCT03706287|Drug|anlotinib + AP/PC|anlotinib doses to be determined following the completion of Phase I of the study, q.d., p.o. 1-14days every 21 days Pemetrexed(A) 500mg/m2, IV, Day 1; Cisplatin(P) 25mg/m2,IV,Day 1-3 or Carboplatin(C) area under curve(AUC)=5, IV, Day 1; AP or AC will be administered every 21 days starting on Day 1.
15892787|NCT03706274|Drug|CX-188|CX-188
15892788|NCT03706261|Drug|18F-MK-6240|Administration of 5 mCi of 18F-MK-6240 for tau PET.
15892789|NCT03706261|Drug|18F-Florbetaben|Administration of 8.1 mCi as a slow single intravenous bolus (6 sec/mL) in a total volume of up to 10 mL of 18F-Florbetaben for Aβ PET imaging.
15892790|NCT03706248|Other|Blood Draw|20 ml of blood will be drawn from subjects via venipuncture
15892791|NCT03706235|Other|Blood draw (venipuncture)|Draw 40 mls of blood from eligible subjects. Process and ship samples to sponsor.
15892792|NCT03706222|Drug|elbasvir/grazoprevir|Comedications during elbasvir/grazoprevir will be recorded and analyzed for potential drug-drug interaction.
15892793|NCT03706209|Drug|MP1032|hard gelatin capsules containing 50mg MP1032 as active ingredient
15892794|NCT03706209|Drug|Placebo|hard gelatin capsules containing no active ingredient
15892795|NCT03706183|Diagnostic Test|Ischemia-modified albumin|The biomarker was investigated in many studies and it was associated with the ischemia and tissue injury.
15892796|NCT03706183|Diagnostic Test|Hearing thresholds|The hearing levels will be determined for each group.
15892797|NCT03706170|Behavioral|Physiological recording in response to different types of stimuli|In order to answer these questions, the study is designed to record in a single session: (i) physiological vegetative reactions (electrodermal, pupillary responses and heart rate) to emotional stimuli ; (ii) a neurophysiological marker of consciousness; and (iii) physiological parameters during a trace conditioning experiment using auditory stimuli with and without emotional valence.
15892798|NCT03706170|Behavioral|EEG recording in response to different types of stimuli|In order to answer these questions, the study is designed to record in a single session: (i) physiological vegetative reactions (electrodermal, pupillary responses and heart rate) to emotional stimuli ; (ii) a neurophysiological marker of consciousness; and (iii) physiological parameters during a trace conditioning experiment using auditory stimuli with and without emotional valence.
15892799|NCT03706157|Drug|Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc iso-osmolar ionic iodinated contrast media|Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc iso-osmolar ionic iodinated contrast media
15892800|NCT03706157|Drug|Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc normal saline|Super selective transarterial chemoembolization of CHC, with doxorubicin reconstituted in 5cc normal saline
15892801|NCT03706144|Other|Prodigy Math Training|https://www.prodigygame.com/
15892802|NCT03706131|Other|cervical mobilisation|manual therapy
15892803|NCT03706118|Other|Magnetic resonance imaging|At month 0, 12, 24 and 36 participants will be examined by quantitative magnetic resonance imaging of brain, cervical and part of thoracic spine.
15892804|NCT03706105|Behavioral|Cardiac Rehabilitation|3 x week ~1 hour of exercise + education
15892805|NCT03706079|Biological|Tezepelumab|Tezepelumab subcutaneous injection
15892806|NCT03706079|Other|Placebo|Placebo subcutaneous injection
15892807|NCT03706066|Device|Acrysof IQ PanOptix IOL|Single-piece, ultraviolet and blue-light filtering, foldable, multifocal intraocular lens (IOL) inserted into the capsular bag during cataract surgery
15892808|NCT03706066|Procedure|Cataract surgery|Per investigator's standard of care
15892809|NCT03706053|Drug|Midodrine Hydrochloride|Midodrine Hydrochloride, enteral, 10 or 20 mg
15892810|NCT03706053|Other|placebo|investigational pharmacy formulated placebo comparator
15892811|NCT03706040|Biological|placebo for rizankizumab|subcutaneous (SC) injection
15892812|NCT03706040|Biological|risankizumab|subcutaneous (SC) injection
15892813|NCT03706027|Device|radiation therapy-3 fractions|Radiation therapy given in a 3 fraction schedule (over 3 days). Total dose is 54 Grays.
15892814|NCT03706027|Device|Radiation therapy-5 fractions|Radiation therapy given in 5 fractions (over 5 days). Total dose is 60 Grays.
15892815|NCT03706014|Behavioral|SIBS Program|Universal prevention program promoting positive sibling and family relationships conducted in an afterschool setting
15892816|NCT03706014|Behavioral|Control|Contact-equivalent attention control program in which students play educational games
15892817|NCT03706001|Other|Psychotherapy|Psychotherapy has gained increasing acceptance as a major treatment option for mood disorders.
15892818|NCT03705988|Device|Cranial Electrotherapy Stimulation(CES)|Cranial electrotherapy stimulation (CES) has been known as a kind of noninvasive treatment, which applies pulsed, weak electrical current to head through two electrodes that placed on the earlobes. The current intensity could be adjusted continuously from 500 μA~2mA.
15892819|NCT03705988|Device|sham Cranial Electrotherapy Stimulation( sham CES)|Cranial electrotherapy stimulation (CES) has been known as a kind of noninvasive treatment, which applies pulsed, weak electrical current to head through two electrodes that placed on the earlobes. The sham CES devices were identical to the active device, except the ear clip electrodes emit electricity intensity of lower than 100 μA.
15892820|NCT03705975|Other|Manual treatment|Scapula mobilization, glenohumeral joint mobilization
15892821|NCT03705962|Drug|Tobramycin|
15892822|NCT03705962|Other|Placebo: normal saline|
15892823|NCT03705949|Drug|Sodium Hyaluronate 0.1% drops|Patients will be administered Drops of Sodium Hyaluronate 0.1% quid
15892824|NCT03705949|Drug|Sodium Hyaluronate 0.2% drops|Patients will be administered Drops of Sodium Hyaluronate 0.2% quid
15892825|NCT03705936|Device|rTMS|rTMS is a non-invasive brain stimulation technique. It can regulate brain activities with electrical pulses sent to the brain through electromagnetic induction.
15907908|NCT03588390|Drug|Placebo|Placebo to high strength tablet
15892827|NCT03705910|Other|Perceptive Rehabilitation|"In each session, over one hundred cones will be placed on a rigid wooden base using elastic strips. The patient will be asked to lie down supine on the material. Patients weigh will create pressure and reaction force to his/her body. Treatments will be 2 times a week till 8 weeks.
~The therapist will ask the patient firstly to breathe normally and feel the pressure. The patient will then perform breathing exercises and active exercises (including stretching, warming up, and cooling down) under supervision. During the session, the therapist will ask about the pressure of the cones and will correct the patient's posture. At the end of each session, the therapist will photograph the patient's back with the aim of documenting the pressure and hyperaemic areas."
15892828|NCT03705910|Other|Mobilisation Techniques|"A certified physiotherapist will perform mobilisation techniques. All participants in this group will receive treatment protocol according to the list on below. Treatments will be 2 times a week till 8 weeks.
~For this treatment, the participant should lie on a bed and change their position according to the technique (supine, position or side-lying). Also, the therapist will be changing her position according to the technique. All technique will be on the range of motion limit. For releasing techniques the therapist will apply three-dimensional pressures till 3-5 minutes, with the feeling of relaxing therapist will change the limit for the next point."
15892829|NCT03705897|Other|Computerized Risk Stratification Tool|Implement a novel computerized risk stratification tool in Parkland community-oriented primary-care clinics that collects data directly from patients and uses a computerized algorithm system to generate their personalized guideline-based next steps in the screening regimen
15892830|NCT03705897|Other|Algorithmic Risk Stratification Tool|Implement a novel algorithmic risk stratification system in Parkland's endoscopy clinics that, based on test findings entered by colonoscopists, generates personalized guideline-based next steps in the screening regimen for patients with colorectal polyps removed at olonoscopy
15892831|NCT03705897|Other|Step completion assessment|Assess completion of guideline-recommended steps in personalized screening regimens, under-screening, and over-screening
15892832|NCT03705884|Other|18F-FDG|Hybrid 18F-FDG PET/MR imaging for observational diagnostic purposes.
15892833|NCT03705884|Drug|Prednisolone|Oral course of Prednisolone for treatment of sarcoidosis (patient cohort) or as control (healthy volunteer cohort)
15892834|NCT03705871|Device|Differential Expansion|Twenty-four patients will be treated with a rapid maxillary expansion using the expander with differential opening. Appliance anchorage will be performed by bands adapted in the second maxillary deciduous molars and circumferential clamps will be bonded to the maxillary deciduous canines. The activation protocols will totalize an opening of 8mm in the anterior screw of the expander. After the active period of RME, the screws will be fixed with acrylic resin and the appliance will be kept as a retainer for 6 months.
15892835|NCT03705871|Device|Fan-Fype Expander|Twenty-four patients will be treated with a rapid maxillary expansion using the fan-type expander. Appliance anchorage will be performed by bands adapted in the second maxillary deciduous molars and circumferential clamps will be bonded to the maxillary deciduous canines. The activation protocols will totalize an opening of 8mm screw of the expander. After the active period of RME, the screws will be fixed with acrylic resin and the appliance will be kept as a retainer for 6 months.
15892836|NCT03705858|Drug|Ac-Lintuzumab|225Ac-lintuzumab will administered at 4 dose levels: 0.25, 0.5, 0.75 or 1 µCi/kg intravenously (IV) over 30 ± 10 minutes. The starting dose will be 0.5 µCi/kg. A dose of 0.25 µCi/kg will be studied only if 0.5 µCi/kg is determined to exceed the MTD. The lintuzumab dose will be adjusted to maintain a specific activity of 0.16 µCi/µg
15892837|NCT03705845|Drug|placebo softgel|Each placebo softgel of 430 mg olive oil will contain no TT or tocopherols at detectable levels.
15892838|NCT03705845|Drug|DeltaGold® Tocotrienol 70%|DeltaGold® Tocotrienol 70% contains 430 mg tocotrienol (90% δ-tocotrienol + 10% γ-tocotrienol) with a 70% purity, representing 300 mg tocotrienol.
15892839|NCT03705832|Drug|Ginger Extract|2gm Capsule of Ginger extract
15892840|NCT03705832|Drug|Placebo|Matching Placebo
15892841|NCT03705819|Drug|[11C]-NOP46|Subjects will receive a microdose (≤10 µg) of [11C]-NOP46.
15892842|NCT03705819|Radiation|PET/CT scan|After subjects receive a microdose of [11C]-NOP46, whole body PET/CT scan(s) will be performed to determine dosimetry and perform an initial safety evaluation of the radiotracer in Stage 1 and region of interests in Stage 2.
15892843|NCT03705806|Radiation|Radiation combined with immunotherapy|The trial is designed as a prospective observational single arm study investigating stage IV non-small cell lung cancer patients who are routinely treated with a PD-1 inhibitor for indications approved by Health Canada. All patients who are selected will be referred for palliative thoracic radiotherapy and treated with a standard dose prescription of 30 Gy in 10 fractions.
15892844|NCT03705793|Drug|Mometasone Furoate Nasal Irrigation|Participants will undergo an 8-week treatment course that includes nasal saline irrigation with mometasone powder and placebo nasal spray.
15892845|NCT03705793|Drug|Mometasone Nasal Spray|Participants will undergo an 8-week treatment course that includes placebo saline irrigation with mometasone nasal spray.
15892846|NCT03705780|Other|the short OSAS scale|Parents fill in the short OSAS screening scale in preoperative interview，calculate score of the scale.
15892847|NCT03705780|Diagnostic Test|fentanyl test|In the operating room，giving 1 mcg/kg fentanyl when the End-tidal concentrations of sevoflurane were maintained at 3.0 and the spontaneous respiratory frequency was stable after eyelash reflex disappeared and pharyngeal airway insertion, observing the changes of respiratory rate
15892848|NCT03705754|Device|carbon black suspension colonic tattoo injection|Examine the SPOT syringe to verify that the pigment is fully suspended. A 23 or 25 G sclerotherapy needle is recommended for this procedure, attach the syringe and prime with SPOT. After injection catheter is primed, manoeuver with the endoscope for optimal injection position and inject tangentially, at a 30-40˚ angle to the mucosa and create a saline bleb to find the submucosal plane prior to injecting SPOT to reduce risk of intramural injection. Document both the depth of scope and anatomic location of each tattoo and the ink consumption as well. Place injection 2-3 cm distal (downstream) of the area of interest. Use 0.5-0.75 mL per injection site and no more than 8 mL per patient. Place SPOT tattoos in 3-4 quadrants around the lumen to increase likelihood of visualisation.
15892849|NCT03705741|Behavioral|Resistance exercise|Resistance exercise twice a week during pregnancy week 23-34.
15892850|NCT03705728|Drug|Propofol|"Propofol will be automatically administered according to the EasyTIVA device algorythm to maintain the BIS value within the 40-60 interval"
15892851|NCT03705728|Drug|Sevoflurane|Sevoflurane will be manually administered to maintain the BIS value within the 40-60 interval
15892852|NCT03705728|Drug|Remifentanil automatic|"Remifentanil will be automatically administered according to the EasyTIVA device algorythm to maintain the BIS value within the 40-60 interval"
15892853|NCT03705728|Drug|Remifentanil manual|Remifentanil will be manually administered to maintain the BIS value within the 40-60 interval
15892854|NCT03705715|Drug|PET with radiotracer [11C]PBR-28 ( or [11C]ER176)|[11C]PBR-28 or [11C]ER176 will be injected into subjects' veins during PET scanning.
15892855|NCT03705715|Other|Affective challenge|Affective challenge is the induction of, for example, mood or affective pain.
15892856|NCT03705702|Other|Education Program|The educational program will consist of 2 classes held once a week, each lasting 90 minutes. The classes will be based on an education videotape, presentations and group discussions. The first class will address the asthma education, which will include information about the pathophysiology of asthma, medication and peak flow meter instructions, self-monitoring techniques, environmental control techniques and avoidance strategies. The second class will be about the current international physical activity recommendations and the importance and benefits of being physically active and maintain a healthy lifestyle.
15892857|NCT03705702|Behavioral|Behavioral intervention|The behavioural intervention will be performed in 8 weekly goal-setting consultation, face-to-face, each lasting 40 minutes. Patients will be offered a commercially-available activity tracker to wear during 3 days prior to each consultation. According to their own PA data and the behavioural change stage, an individual action plan will be established with realistic goals to increase PA. Each participant will receive individual counselling with the goal of increasing participation in PA and reducing their sedentary time. Techniques such as weekly goal-setting, motivational interviewing, activity tracker vibration instructions, self-management, positive reinforcement, relapse prevention and strategies to overcome barriers will be included.
15892858|NCT03705689|Other|validation of Bitts|No intervention, observation of photographs of stool
15892859|NCT03705676|Behavioral|Rapid Arm Movements|240 trials of RAM in either a forward (50%) or backward (50%) shoulder flexion direction and back to neutral as fast as possible, with maintaining extension in the elbow. Visual cues (arrows) indicated the movement direction.
15892860|NCT03705676|Device|Unpleasant stimulus|An unpleasant, but harmless, electrocutaneous stimulus is administered to the low back region in 25% of the threat trials during the fear condition. Due to a conditioning phase before testing, participants know to expect this stimulus after the presentation of a warning cue related to the fear trials (either pink or blue dot dependent on randomization).
15892861|NCT03705676|Device|Vibrotactile stimulus|In all trials, during the presentation of the warning cue, a vibrotactile stimulus is administered to the low back region. This stimulus is used to evoke somatosensory evoked potentials (SEP) measured with EEG during the movement-preparation phase.
15892862|NCT03705663|Behavioral|PrEP initiation|Women who are interested in or who initiate PrEP will be followed in a prospective cohort to identify and populate the PrEP cascade for cis-gender, high risk women
15892863|NCT03705650|Diagnostic Test|Limited Echocardiogram|STUDY SOFTWARE non-significant risk (NSR) Bay Labs EchoGPS software interfaced with the Terason uSmart 3200t FDA 510(k)-cleared, commercially available ultrasound EchoGPS software communicates with the ultrasound image formation engine of the 510(k)-cleared Terason uSmart 3200t through an application programming interface (API). EchoGPS will be used to provide visual guidance, feedback and interpretation assistance to users during image acquisition. For this study, CMAs will use EchoGPS to perform point-of-care echocardiogram examinations.
15892864|NCT03705637|Drug|Exparel|"Donor sites will receive up to 50mg of 0.25marcaine with epinephrine injected uniformly into the wound.
~The donor site will also receive one bottle (266mg) of Exparel, diluted to be administered uniformly into the entire donor site, spaced out ever 3-4cm. The dilution will be as follows:
~o 20ml Exparel + 10ml injectable 0.9% NS (30ml) for every 100cm2 of donor site.
~Injection of local anesthesia will be performed after the donor site has been harvested and is hemostatic. The goal is to provide the maximum time possible for the local anesthetic to work while under anesthesia, so it can benefit the patient and not be administered at the end of the case just prior to extubation."
15892865|NCT03705624|Other|Enhanced Community Case Management (CCM)|Enhanced Community Case Management for malaria (CCM) involving weekly active screening for fever using a research-grade thermometer by a trained health worker. A measured temperature ≥37.5°C or reported fever in the last 24 hours will prompt screening with a conventional rapid diagnostic test (RDT). RDT positive individuals will be treated with AL according to national guidelines
15892866|NCT03705624|Other|Monthly Screening and Treatment (MSAT)|Monthly Screening and Treatment (MSAT) regardless of symptoms with a conventional RDT. Screening will be performed by research staff with 25-35 days between screening rounds; RDT positive individuals will be treated with AL according to national guidelines.
15892867|NCT03705611|Diagnostic Test|HIV self-testing only|Partners will be asked to self-test for HIV following receipt of the test kit from their sexual contact at home or in the community. They will also get information about the partner's clinic -- an HIV testing service room dedicated to providing HIV testing, confirmatory HIV testing, and referral to HIV treatment and prevention services including couples counselling.
15892868|NCT03705611|Behavioral|HIV self-testing secondary accuracy|A monetary incentive provided conditional on clinic attendance and fulfillment of secondary accuracy procedures such as undergoing on spot finger prick rapid HIV testing
15892869|NCT03705598|Behavioral|Light physical exercise|One hour each session, two sessions each week, for 24 weeks. Each session includes 10 minutes of warm up, 30 minutes of normal walking, light intensity resistance exercise and stretching, and 20 minutes of health education discussions, supervised by a certified exercise physiologist and a research assistant.
15892870|NCT03705598|Behavioral|Tai Chi|One hour each session, two sessions each week, for 24 weeks. Each session includes 10 minutes of warm-up that included joint rotations and balance games, 45 minutes of Tai Chi practice that included Tai Chi walking drills and the 8 forms (with 12-15 minutes of breaks), and 5 minutes of cool down and breathing exercises, supervised by an experienced Tai Chi instructor and a research assistant.
15892871|NCT03705585|Drug|Vivotif Typhoid Oral Vaccine|The 4 doses (1 capsule each) will be administered on alternate days, e.g., days 0, 2, 4, and 7 (± 1 day) under the supervision of the study coordinator(s).
15892910|NCT03705234|Drug|Placebo|Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).
15892872|NCT03705585|Drug|Vaxchora|One dose. Approximately 100 mL of cool or room temperature purified bottled water is placed into a clean disposable cup. The contents of the buffer sachet are added to the water and stirred. Then the contents of the active (lyophilized vaccine) sachet are added to the water and stirred for approximately 30 seconds. The reconstituted mixture should be completely ingested within 15 minutes.
15892873|NCT03705572|Dietary Supplement|Lacprodan PL20|Milk protein concentrate that is high in phospholipid content (min 16%).
15892874|NCT03705572|Other|Placebo|Placebo milk drink.
15892875|NCT03705559|Drug|Vaporized Marijuana|Active Marijuana or Placebo, administered through vaporizer
15892876|NCT03705559|Drug|Opioid Agonist|Active Opioid Agonist or Placebo, administered intranasally
15892877|NCT03705533|Drug|Telmisartan|Telmisartan is manufactured by Pharmtechnology LLC, Belarus. Each tablet contains 80 mg of telmisartan.
15892878|NCT03705533|Drug|Micardis|Micardis is manufactured by Boehringer Ingelheim Ellas AE, Greece. Each tablet contains 80 mg of telmisartan.
15892879|NCT03705507|Drug|Selumetinib|Selumetinib is a small molecule inhibitor of the MEK protein
15892880|NCT03705507|Drug|Dexamethasone|Steroid used for the treatment and management of a number of conditions including cancers and leukaemias.
15892881|NCT03705494|Other|Home-based peer counselling intervention|The intervention consists of 5-6 home based visits over 6 months by trained peer counsellors who will focus on breastfeeding among mothers who have already decided to breastfeed and are interested in this programme.
15892882|NCT03705481|Device|Remote treatment of PCI.|To evaluate the safety and performance of CorPath GRX POP System, in the ReMOTE (location outside hospital) delivery and manipulation of coronary guidewires and stent/balloon catheters, and manipulation of guide catheters during PCI procedures.
15892883|NCT03705455|Behavioral|ISAP SMS|ISAP SMS is a text message for caregivers use that provides immunization schedule and vaccine availability at the nearest immunization clinic.
15892884|NCT03705442|Dietary Supplement|Omni-Biotic 10|All patients will have at their disposal current medications for diarrhea based on guidelines, and education regarding side effects and dietary recommendations will be undertaken. One cohort will also ingest a probiotic (OMNi-BiOTiC® 10AAD), while other cohort will take a placebo, same in colour, shape, taste and smell; both medications will be taken 2 per day, every 12 hours, over 84 days (6 chemotherapy cycles every 14 days).
15892885|NCT03705442|Drug|"loperamide (Seldiar)"|All the patients will have access to standard drugs for diarrhoea
15892886|NCT03705429|Drug|TC-H x Paclitaxel (P) + Trastuzumab(T)|chemotherapy
15892887|NCT03705416|Procedure|Endoscopy|endoscopic suturing of stomach
15892888|NCT03705416|Procedure|Surgery|Vertical sleeve gastrectomy (VSG) surgical reduction of stomach, or (RYGBP) , or gastric bypass procedure
15892889|NCT03705403|Drug|Darleukin|The product name refers to the molecule structure, in fact, L19-IL2 is a recombinant fusion protein composed of two moieties: L19, a human monoclonal antibody fragment in the single chain Fv (scFv) format, bound via a flexible linker to IL2, the human cytokine Interleukin-2.
15892890|NCT03705403|Radiation|Radiation|Radiotherapy
15892891|NCT03705390|Drug|ILB|Administration will be weekly subcutaneous injections at a dose of 2mg/kg once per week for up to a maximum of 48 weeks
15892892|NCT03705364|Other|Fall Management program|Comprehensive fall management program that develops strategies for non-ambulatory wheelchair users living with MS to develpo strategies to recover from a fall.
15892893|NCT03705351|Device|Tumor Treating Fields|Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM). Treatment will begin approximately 1 week prior to start of radiation and temozolomide treatment and continue concurrently throughout the duration of the study.
15892894|NCT03705351|Drug|Temozolomide|Patients will be given temozolomide according to routine treatment dosing and schedule.
15892895|NCT03705351|Radiation|Radiation Therapy|Patients will be given radiation therapy according to routine treatment dosing and schedule.
15892896|NCT03705338|Device|Electroencephalography|Measure the appearance and disappearance of frontal alpha wave with EE, when them loss and recovery of consciousness under general anesthesia with propofol.
15892897|NCT03705338|Drug|Propofol|Recorder the loss and recovery of consciousness in children under general anesthesia with TCI of propofol intravenous. Induction will be started with 20 mg/kg/hr of propofol up to UMSS level 4. Then will be titrated leading anesthesiologist criteria.
15892898|NCT03705325|Device|Spirobank Smart spirometer|The spirometer is a compact, portable, home-based spirometer that pairs with a smartphone app. Exhaled air flow causes the turbine to rotate, generating a voltage analogous to the rate of air flow across the turbine. The spirometer measures Forced expiratory volume in 1 second (FEV1), or the volume of air that is exhaled in the first second. The device prompts the user to perform a minimum of three expiratory maneuvers in and records the best of the three maneuvers. The information generated is then transmitted to the VitalFlo App (password protected) on the user's iPhone. The user is alerted, by the App, if their expiratory effort is inadequate (such as early termination of exhalation) and is provided coaching for proper technique.
15892899|NCT03705312|Device|Transcatheter mitral valve repair|Transcatheter mitral valve repair performed using the MitraClip device
15892900|NCT03705312|Other|Guideline-directed medical therapy|Standard medical therapy for heart failure as recommended by HF guidelines
15892901|NCT03705299|Device|Non-Invasive CVP vs Standard CVP|
15892902|NCT03705286|Device|EVAC-PU-ETT|Placement of a EVAC-PU-ETT in the setting of emergent intubation.
15892903|NCT03705286|Device|PVC-ETT|Placement of a PVC-ETT in the setting of emergent intubation.
15892904|NCT03705273|Drug|Dexamethasone IV for PO|Common pediatric emergency department practice
15892905|NCT03705273|Drug|Dexamethasone crushed tablets|Alternative route of administration for patients unable to swallow tablet whole
15892906|NCT03705260|Other|Usual Care|Usual care from Primary Care Physician and dietitian.
15892907|NCT03705260|Behavioral|Intensive Behavioral Intervention|The intensive behavioral intervention which will incorporate lower carbohydrate diet, diet coaching, and more intensive glucose monitoring.
15892908|NCT03705260|Other|Monthly Screening for Risk|Monthly screening of HbA1C to identify patents who have become poorly controlled in the interval.
15892909|NCT03705234|Drug|Inclisiran|Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
15909885|NCT03573960|Drug|Lenvatinib|Lenvatinib capsules.
15892912|NCT03705221|Behavioral|Healthy Parent Carers online resources|Online resources related to health and wellbeing
15892913|NCT03705208|Other|Youth First Curriculum|A 25 session emotional resilience and health curriculum designed for 7th and 8th grade students.
15892914|NCT03705195|Drug|Gliclazide|Low dose liquid gliclazide will be used with the second matched clamp (OGTT/IGII) in visits 4 & 5.
15892915|NCT03705182|Device|Fluorescence visualization (feedback)|UVA-light will illuminate the skin of head, neck, arms and hands and the fluorescent areas will be recorded and quantified by a computer vision system each time the participant leaves a production area. The intervention group will be shown the fluorescent areas on their skin, the control group will not have this opportunity
15892916|NCT03705169|Biological|SAR441236|Administered by intravenous (IV) infusion or subcutaneous (SC) injection
15892917|NCT03705169|Biological|Placebo|Administered by intravenous (IV) infusion or subcutaneous (SC) injection
15892918|NCT03705169|Drug|Antiretroviral treatment|Antiretroviral treatment will be prescribed by participants' primary HIV clinician. It is not provided by the study.
15892919|NCT03705156|Drug|ZL-2306(nirapairb)|The starting dose is 300 mg or 200 mg based on patient's body weight.
15892920|NCT03705156|Drug|Placebos|The starting dose is the matched dose of placebo (3 capsules or 2 capsules).
15892921|NCT03705143|Behavioral|Treatment as usual|Treatment as Usual participants will receive the treatment typically provided to patients at the MMT clinic in Wuhan, China.
15892922|NCT03705143|Behavioral|Chinese translated LETS ACT|The Chinese translated Behavioral Activation (C-BA) will be provided in Mandarin. C-BA treatment includes psychoeducation regarding the link between mood and behavior, identification of values/goals/activities across life areas, planning and tracking of daily value driven activities.
15892923|NCT03705130|Device|Single Vision Contact Lens|Spherical Contact Lens worn on non-dispensing basis
15892924|NCT03705130|Device|Multifocal Contact Lens 1|Multifocal Contact Lens worn on non-dispensing basis
15892925|NCT03705130|Device|Multifocal Contact Lens 2|Multifocal Contact Lens worn on non-dispensing basis
15892926|NCT03705117|Biological|V565|Capsules for oral administration
15892927|NCT03705104|Behavioral|EPIO|App for self-management of chronic pain An app consisting of 9 modules focusing on cognitive behavioral pain self-management.
15892928|NCT03705091|Diagnostic Test|Magnetic resonance imaging|ASL and DWI MRI
15892929|NCT03705078|Procedure|Transjugular Portosytemic Shunt (TIPS)|The TIPS is placed under radiologic guidance. A branch of the intrahepatic portal vein is punctured; afterwards, the splenic vein is catheterized so that a portal venography and pressure measurements can be performed. Then, the parenchymal track is dilated and a stent is placed. A final portography and pressure measurement in the main portal vein and the inferior caval vein are performed.
15892930|NCT03705078|Procedure|glue obliteration|The standard protocol uses cyanoacrylate and lipiodol in 1:1 ratio injecting with no more than 1 mL at the varix each time. In most cases, cyanoacrylate is usually extruded into the stomach lumen within 1-3 months after injection. The French observational survey observed that a large majority (78%) of practitioners diluted glue with lipiodol and most (68%) proposed a proportion of glue to lipiodol of 1:1 the total volume injected per varix (from 1mL to 20 mL) varied substantially. Regarding the type of glue, although the majority of published data concern Histoacryl®, nearly half of practitioners used Glubran®. This lack of preference for one glue over the other may be explained by the fact that only Glubran® is approved in this indication in Europe.
15892931|NCT03705065|Drug|Bupivacaine HCl|Bupivacaine HCl without epinephrine 0.25%, 60 mL (30 mL per pectoral pocket)
15892932|NCT03705052|Other|Questionnaire|Patients and caregivers were asked to complete a questionnaire
15892933|NCT03705039|Other|Pulsed Ultrasound Treatment|Patients will receive treatment with 1 MHz probe with the intensity of 1w/cm2, pulsed at a ratio of 1:4 for 10 minutes and at an interval of 3 sessions per week during 8 weeks, a total of 24 sessions.
15892934|NCT03705039|Other|Control group|Sham US will be applied to control group for the same times and periods as treatment group. A home exercise program will be given to both of two groups which contains knee range of motion and isometric strengthening exercises.
15892935|NCT03705013|Other|Cologuard|Observational
15892936|NCT03705000|Device|Slit Stent II|The Slit-Stent II device is created by modifying the BIKA for DCR lacrimal stent through the addition of a center slit, 12 ± 1.5 mm in length, and two lateral slits 32 ± 4.5 mm in length, each having identical depth measurements to facilitate the drainage of tears. The BIKA for DCR is a sterile, single-use device that is FDA cleared as part of the BIKA family of devices under K911109..There are no changes to the raw materials used in making the modifications to the BIKA for DCR during the manufacturing of the Slit Stent II.
15892937|NCT03705000|Device|BIKA for DCR|The BIKA for DCR lacrimal stent is a bicanalicular intubation device used for intubation of the lacrimal drainage apparatus, especially in cases of dacryocystorhinostomy (conventional or laser). The silicone tube acts as a conformer during the healing process while facilitating drainage of tears through capillary action around the stent. In cases of canalicular lacerations, the silicone tube guides wound healing and prevents the onset of synechia. The BIKA for DCR is a sterile, single-use device, and is an FDA cleared device
15892938|NCT03704987|Diagnostic Test|dual-energy X-ray absorptiometry|dual-energy X-ray absorptiometry
15892939|NCT03704974|Behavioral|Video-Based Parent Training Program|An18-20 week evidence-based social cognitive theory-based parenting program where parents see brief video vignettes of effective and less effective parenting and develop concepts to modify their child's behavior.
15892940|NCT03704961|Behavioral|music and audiobook listening|
15892941|NCT03704948|Behavioral|Listening Visits|6 sessions, approximately one hour in length, delivered by a nurse who uses empathic listening and problem solving.
15892942|NCT03704948|Behavioral|Standard Care (Social Work)|Mental health services provided by social workers to emotionally distressed mothers.
15892943|NCT03704922|Biological|Transfusion|Red cell units for transfusion
15892944|NCT03704909|Drug|Adrenaline|i.v bolus of adrenaline 0.15µg/Kg rescue boluses of adrenaline 0.15µg/Kg
15892945|NCT03704909|Drug|Ephedrine|i.v bolus of Ephedrine 0.1mg/Kg rescue boluses of Ephedrine 0.1mg/Kg
15892946|NCT03704896|Other|Lung function measurement|Spirometry-derived lung function measurements
15892947|NCT03704870|Diagnostic Test|Chest Xray|Daily chest xray
15892948|NCT03704870|Diagnostic Test|No daily chest xray|Chest xray will be done post chest tube removal only
15892949|NCT03704857|Other|Foraminal Enlargement / Irrigating solutions / Filling materials|"Instrumentation with foraminal enlargement and various irrigation solutions and filling materials will be performed according to the allocated group.
~The foraminal enlargement provides better results in the bacterial removal of the apical portion of the root canal. This instrumentation will be done with the Reciproc 40 or 50 system in the apical foramen, determined by the apical locator.
~To contribute to disinfection of the root canal, sodium hypochlorite and chlorhexidine are the most widely used irrigators. Sodium hypochlorite has a broad antimicrobial spectrum and an effective ability to dissolve organic matter and necrotic tissue; while chlorhexidine shows substantivity and antimicrobial residual activity when used as an irrigating substance.
~Besides that, MTA Fillapex or AH Plus will be used and the recommended filling technique will be lateral condensation."
15892950|NCT03704857|Other|Photodynamic therapy|PDT will be performed with 0.01% methylene blue solution and it will be inserted into the root canal for 5 minutes. The excess will be removed and irradiation will be performed inside the root canal with the red laser of Índio Gálio Alumínio Fósforo (660nm, Laser Duo, MMOptics, São Paulo, SP, Brazil) for 90 seconds. Laser therapy with Gallium-Aluminum-Arsenic infrared laser (808nm, Laser Duo, MMOptics, São Paulo, SP, Brazil) will be performed on the gingiva from the vestibular face and on the palatal / lingual face, both located in the periapical region for 40 seconds.
15892951|NCT03704857|Other|Passive ultrasonic irrigation|PUI will be performed with Newtron P5 ultrasound (Satelec / Acteon Group, Bordeaux, France), at intensity 9 and with a 25mm (# 0.25, taper 0.00). The protocol of use will be 3 sequences of 20 seconds of ultrasonic activation with 2 ml of sodium hypochlorite 2.5% in each root canal.
15892952|NCT03704857|Other|OHIP-14|Patients will respond a quality of life questionnaire (OHIP-14) on the day of endodontic treatment, on the 7th day and on the 30th day.
15892953|NCT03704857|Other|Assessment of pain and swelling|The analysis of the postoperative signs/symptoms will be performed by the visual analog pain scale at 1th, 2th, 3th, 4th, 5th, 6th, 7th, 14th and 30th days and by the subjective evaluation of swelling in 48 and 72 hours.
15892954|NCT03704857|Other|Assessment of periapical lesion|The periapical lesion repair will be evaluated clinically and radiographically at 3, 6, 12, 18 and 24 months.
15892955|NCT03704844|Other|non applicable|non applicable
15892956|NCT03704831|Other|Injection of local anesthetics during total knee arthroplasty by a locoregional anesthesia named IPACK block|Injection of local anesthetics during total knee arthroplasty by a locoregional anesthesia named IPACK block (Interspace between the Popliteal Artery and the Capsule of the posterior Knee)
15892957|NCT03704831|Other|Injection of local anesthetics during total knee arthroplasty by surgical infiltration|Injection of local anesthetics during total knee arthroplasty by surgical infiltration.
15892958|NCT03704818|Drug|Dapagliflozin 5mg|Dapagliflozin treatment taken daily for 4-weeks.
15892959|NCT03704818|Drug|Placebo Oral Tablet|Placebo treatment taken daily for 4-weeks.
15892960|NCT03704805|Behavioral|Friendship bench intervention|The friendship bench intervention consists of six individual counseling sessions and a peer-led group activity. Individual counseling is based on problem-solving therapy and delivered by lay health workers. During individual counseling, participants will be actively encouraged to identify and tackle problems leading to sub-optimal antiretroviral therapy adherence. In the group activity, participants are taught an income generating skill and have the opportunity to share personal experience with former participants of the intervention.
15892961|NCT03704805|Other|Enhanced Standard of Care|Study participants receive information on available routine services for common mental disorders, a nurse-led brief support counseling, assessment for antidepressant medication (fluoxetine) by the clinic nurse, and referral to a psychiatric facility if needed, in addition to the standard of care provided according to national antiretroviral therapy guidelines.
15892962|NCT03704792|Device|FibroScan 530 Compact|The FibroScan® is a device equipped with probes (M+ or XL+), each of which consists of an ultrasonic transducer mounted on the axis of a mechanical vibrator. Liver stiffness and CAP measurements are performed on the right lobe of the liver with the patient in a dorsal decubitus and maximal abduction position. The procedure is non-invasive and painless.
15892963|NCT03704779|Behavioral|Multimodal mindfulness activity program|"This program will provide the opportunity for participants to engage in in-person and online activities. The in-person activities will be held from 12:00 pm to 12:45 pm in the Georgian Physical Therapy Lab (and offered twice per week). The online activities will be available at all times during the study at convenience. There are one 40-minute in-person and four 10-minute online mindfulness activities per week (combined time of 1 hour and 20 minutes per week).
~In-person activities will consist of mindfulness activities including guided imagery meditation, yoga, Tai Chi, progressive muscle relaxation, creating a Zen garden, aromatherapy, journaling, self-massage, and pet therapy. Online materials will additionally include guided and unguided meditations."
15892964|NCT03704766|Diagnostic Test|Synovial Alpha-defensin assay|One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
15892965|NCT03704766|Diagnostic Test|Synovial Neutrophil elastase assay|One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
15892966|NCT03704766|Diagnostic Test|Synovial lactate assay|Synovial Fluid (joint fluid) will be sent out to CD Diagnostics for this test.
15892967|NCT03704766|Diagnostic Test|Synovial C-reactive Protein (CRP)|One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
15892968|NCT03704766|Diagnostic Test|Synovial Staphylococcus spp antigen panel|One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
15892969|NCT03704766|Diagnostic Test|Synovial Candida spp antigen panel|One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
15892970|NCT03704766|Diagnostic Test|Synovial Enterococcus faecalis assay|One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
15892971|NCT03704766|Diagnostic Test|Synovial bacterial culture by BacT/Alert|The synovial fluid (joint fluid) sent to CD Diagnostics for testing will also be cultured to see if any organisms grow.
15892972|NCT03704766|Diagnostic Test|Synovial Cell count + differential (CBC)|One of the synovial fluid (joint fluid) tests that will be performed by the outside lab, CD Diagnostics.
15892973|NCT03704766|Diagnostic Test|Synovial Gram Stain|This will be performed by CD Diagnostics if any organisms are present in the synovial fluid.
15893023|NCT03704506|Drug|Reyanning mixture|Reyanning mixture , 20ml by mouth , 3 times per day for 7 days
15892974|NCT03704766|Diagnostic Test|Synovial Leukocyte Esterase Test Strips|These test strips will be tested at the hospital where the patient is being seen, a few drops of synovial fluid will be used on the strip.
15892975|NCT03704766|Diagnostic Test|Synovial PCR for Kingella kingae|In participants < 8 years old, a sample of synovial fluid will be tested for Kingella kingae using PCR.
15892976|NCT03704766|Diagnostic Test|Serum Cell count + differential (CBC)|A blood test performed at the hospital.
15892977|NCT03704766|Diagnostic Test|Serum erythrocyte sedimentation rate (ESR)|A blood test performed at the hospital.
15892978|NCT03704766|Diagnostic Test|Serum C-reactive Protein (CRP)|A blood test performed at the hospital.
15892979|NCT03704766|Diagnostic Test|Serum D-dimer|A blood test performed at the hospital.
15892980|NCT03704766|Diagnostic Test|Serum Procalcitonin|A blood test performed at the hospital.
15892981|NCT03704766|Diagnostic Test|Blood Cultures|Blood will be cultured at the hospital to see if any organisms grow.
15892982|NCT03704766|Diagnostic Test|Optional blood testing per standard of care (ASO, anti-strep, ANA, anti-DS-DNA, HLA-B27, RF, Lyme and other inflammatory/ rheumatologic markers )|In patients with suspected inflammation/infection, there are other blood tests which may be standard of care and used for diagnosis.
15892983|NCT03704753|Drug|Ropivacaine|Serratus anterior plane block for thoracic surgery patients and subpectoral interfascial nerve block for open heart surgery patients
15892984|NCT03704753|Drug|Sodium chloride 0.9%|Serratus anterior plane block for thoracic surgery patients and subpectoral interfascial nerve block for open heart surgery patients (placebo).
15892985|NCT03704740|Biological|NBP607-QIV|Purified inactivated influenza virus surface antigens of four strains (quadrivalent)
15892986|NCT03704740|Biological|Agrippal|Influenza virus surface antigens of three strains (trivalent)
15892987|NCT03704727|Dietary Supplement|Probiotic|Probiotics (beneficial microorganisms) VSL#3 is a probiotic formula containing a mixture of 9x10^10 CFU/g Lactobacilli strains (Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, and Lactobacillus bulgaricus), 8x10^10 CFU/g Bifidum strains (Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis) and 20x10^10 CFU/g Streptococcus thermophilus
15892988|NCT03704714|Drug|Cyclophosphamide|Given IV
15892989|NCT03704714|Drug|Doxorubicin Hydrochloride|Given IV
15892990|NCT03704714|Biological|Nivolumab|Given IV
15892991|NCT03704714|Drug|Prednisone|Given PO
15892992|NCT03704714|Other|Quality-of-Life Assessment|Ancillary studies
15892993|NCT03704714|Biological|Rituximab|Given IV
15892994|NCT03704714|Drug|Vincristine Sulfate|Given IV
15892995|NCT03704701|Diagnostic Test|Cardiac MRI and contrast-enhanced cardiac CT|Cardiac MRI Contrast-enhanced cardiac CT
15892996|NCT03704688|Drug|Trametinib 0.5 mg|0.5mg PO q daily
15892997|NCT03704688|Drug|Trametinib 1 MG|1.0 mg PO q daily
15892998|NCT03704688|Drug|Trametinib 1.5 MG|1.5mg PO q daily
15892999|NCT03704688|Drug|Trametinib 2 mg|2 mg PO q daily
15893000|NCT03704688|Drug|Ponatinib 15 MG|15mg PO q daily
15893001|NCT03704688|Drug|Ponatinib 30 MG|30mg PO q daily
15893002|NCT03704675|Drug|TEW-7197|Administered orally
15893003|NCT03704662|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15893004|NCT03704662|Radiation|Preoperative Fractionated Radiation Therapy and Chemotherapy|Conventional concurrent chemotherapy and radiation therapy.
15893005|NCT03704649|Behavioral|Participatory video|Participatory video education is an intervention model that gives communities the film-making skills necessary to make videos that can be used in nutrition promotion. For the purposes of this study, we will be using a participatory video model as an approach to educate participants in a school-based girls club on nutrition education topics. Participants are taught how to use film equipment and accompanied to draft scripts, create characters, video-record the shots, and act (if they wish) in the video. These videos will be used in the group as a means of sharing nutrition information with students and in stimulating discussion around the nutrition topic.
15893006|NCT03704636|Device|INVSENSOR00028|Noninvasive pulse oximeter sensor
15893007|NCT03704623|Drug|Paracetamol|Paracetamol 1g IV
15893008|NCT03704623|Drug|Parecoxib|Parecoxib 40 mg IV
15893009|NCT03704610|Drug|Infliximab|An initial period with 2 injections with infliximab allowing the determination of the primary criteria Then an extension with infliximab with 3 supplementary perfusions
15893010|NCT03704610|Drug|Placebo|An initial period with 2 injections with placebo allowing the determination of the primary criteria Then an extension with infliximab with 5 supplementary perfusions
15893011|NCT03704597|Other|cryotherapy|Cooling of oral mucosa
15893012|NCT03704584|Drug|Treatment Group (corticosteroid injection plus lidocaine)|Subjects will receive (corticosteroid injection plus lidocaine) that is (40 mg/mL injection of Methylprednisolone or 40mg/mL injection of methylacetate injectable suspension or 40 mg/mL triamcinolone and 1% lidocaine HCl).
15893013|NCT03704584|Drug|Control Group (corticosteroid alone)|Control Group (corticosteroid alone) subjects will receive (40 mg/mL injection of Methylprednisolone acetate injectable suspension or 40 mg/mL triamcinolone) .
15893014|NCT03704571|Drug|Polyethylene Glycol|"In the Tailored group, high-risk people are given intensified bowel preparation regimens, low-risk people are given routine regimens.
~In the control group, all the patients are given routine regimens."
15893015|NCT03704545|Other|Pharmaceutical consultation at the hospital|During 20 minutes, the patient will be educated about chronic obstructive pulmonary disease treatments and their use.
15893016|NCT03704545|Other|Pharmaceutical consultation at the pharmacy|During 20 minutes, the patient will be educated about chronic obstructive pulmonary disease treatments and their use.
15893017|NCT03704545|Other|Follow-up pharmaceutical consultation at the pharmacy|During 10 minutes, the patient will get more information about his chronic obstructive pulmonary disease treatments and their use.
15893018|NCT03704532|Procedure|Operative treatment|Open surgical repair of tendon rupture
15893019|NCT03704532|Procedure|Nonoperative treatment|Nonoperative treatment with lower leg orthosis and functional rehabilitation
15893020|NCT03704519|Drug|Darolutamide (BAY1841788)|300 mg tablet darolutamide, once orally
15893021|NCT03704519|Drug|Enzalutamide|4 x 40 mg capsules, once orally
15893022|NCT03704519|Other|Placebo|4 placebo tablets, once orally
15893024|NCT03704506|Drug|amoxil capsule|amoxil capsule , 0.5g by mouth , 3 times per day for 7 days
15893025|NCT03704506|Drug|Reyanning mixture simulator|Reyanning mixture simulator , 20ml by mouth , 3 times per day for 7 days
15893026|NCT03704506|Drug|amoxil capsule simulator|amoxil capsule simulator , 0.5g by mouth , 3 times per day for 7 days
15893027|NCT03704493|Diagnostic Test|Video Group|A video of a group of five amateur runners running along woods and fields. The group was filmed from behind to give the patient the impression of running within the group.
15893028|NCT03704480|Drug|Durvalumab|1500mg by intravenous (IV) infusion on D1 until progression or unacceptable toxicity or withdrawal of consent
15893029|NCT03704480|Drug|Tremelimumab|300mg by IV infusion on D1 at cycle 1 only
15893030|NCT03704467|Drug|M6620|Participants received 90 milligrams per square meter (mg/m^2) of M6620, intravenously (IV) on Day 2 of every 3 weeks (Q3W) cycle for a maximum of 6 cycles in combination treatment with carboplatin and avelumab on Day 1. The M6620 dose may be de-escalated to 60 mg/m^2, or 40 mg/m^2.
15893031|NCT03704467|Drug|Avelumab|Participants received IV infusion of avelumab 1600 mg on Day 1 of each Q3W cycle for maximum of 6 cycles in combination treatment with carboplatin and M6620. Thereafter, avelumab 800 mg intravenously on Day 1 of every two weeks as a maintenance mono-therapy until progressive disease (PD), unacceptable toxicity, withdrawal of consent, or death.
15893032|NCT03704467|Drug|Carboplatin|Participants received carboplatin area under the concentration-time curve 5 on Day 1 of each Q3W cycle for a maximum of 6 cycles in combination treatment with avelumab and M6620.
15893033|NCT03704454|Dietary Supplement|50 mg PYC and then placebo|4 weeks on PYC, then 4 weeks on placebo
15893034|NCT03704454|Dietary Supplement|100 mg PYC and then placebo|4 weeks on PYC, then 4 weeks on placebo
15893035|NCT03704454|Dietary Supplement|Placebo and then 50 mg PYC|4 weeks on placebo, then 4 weeks on PYC
15893036|NCT03704454|Dietary Supplement|Placebo and then 100 mg PYC|4 weeks on placebo, then 4 weeks of PYC
15893037|NCT03704441|Drug|Bupivacaine|bupivacaine dose
15893038|NCT03704428|Drug|SHR-1314|Pharmaceutical form: Injection solution. Route of administration: subcutaneous injection.
15893039|NCT03704415|Procedure|Extended endoscopic sinus surgery|ESS of all sinuses
15893040|NCT03704415|Procedure|Limited endoscopic sinus surgery|Partial ethmoidectomy
15893041|NCT03704402|Other|Alcohol policy|Introduction of new mutual alcohol policy
15893042|NCT03704389|Behavioral|Clinical decision support|Clinical decision support nudges within the electronic health record
15893047|NCT03704363|Drug|Biosimilar Infliximab|Intravenous infusion(5 mg/kg). Each participant will be given 4 infusions, at day 0, day 14, day 42 and day 98, unless unacceptable toxicity is encountered.
15893048|NCT03704363|Other|Placebo|Intravenous infusion. Each participant will be given 4 infusions, at day 0, day 14, day 42 and day 98,
15893050|NCT03704337|Dietary Supplement|Commercially Available Food Bar|Active
15893051|NCT03704337|Dietary Supplement|Placebo|Placebo
15893052|NCT03704311|Procedure|Muscle biopsy|Local anesthesia was applied to the superficial skin covering the MTrP of each participant. Percutaneous biopsy sampling optimized with a suction-enhancement technique was used to obtain muscle biopsies of the m. trapezius MTrP or the m. gluteus medius MTrP from each participant using small Bergstrom muscle biopsy needle, 8 swg (4.0mm) x 100 mm (Dixons Surgical Instruments, Essex, United Kingdom).
15893057|NCT03704285|Drug|Propofol|Patients undergoing general anesthesia using target controlled infusion of propofol. Initial bolus of 1-2 mg/kg and then a continuous infusion of 10 mg/kg/hr that will be adjusted adjusted to maintain a BIS between 40 and 60.
15893058|NCT03704285|Device|BIS|GeneralAnesthesia maintenance with propofol+remifentanil guided by BIS monitoring.
15893059|NCT03704272|Behavioral|SunBrite|SunBrite is a family-empowered injury risk mitigation intervention with 3 core components: screening for the risk of supervisory neglect associated with traumatic injury in very young children; a brief behavioral intervention using motivational interviewing designed to provide feedback to the caregiver on supervisory risk and traumatic injury; and a referral to treatment for ongoing risks such as substance abuse, trauma or mental illness, requiring specific clinical interventions.
15893060|NCT03704259|Other|Ceramic coating|coating the laparoscope lens with commercial brand ceramic coating, bought from car service centers specialized in such applications
15893061|NCT03704246|Drug|Anti-PD-1 monoclonal antibody|HX008 is a monoclonal antibody drug which is intravenous drip at a dose of 200mg.
15893062|NCT03704233|Procedure|Transbronchial cryobiopsy|Transbronchial cryobiopsy procedure
15893063|NCT03704220|Drug|Warfarin|Removal of anticoagulation with warfarin
15893064|NCT03704207|Other|nNO testing|Collection of already performed clinical data and nNO testing
15893065|NCT03704194|Behavioral|Adapted LiFE|The standardized components include presenting the Adapted LiFE user manual to participants, and teach participants to embed the exercise activities in their daily routine with the LiFE activity calendar.
15893066|NCT03704194|Behavioral|Attention control|Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.
15893067|NCT03704181|Drug|Colchicine 0.5 MG twice day for one year|placebo twice day for one year
15893068|NCT03704181|Drug|Placebo Oral Tablet|placebo twice day for one year
15909886|NCT03573947|Drug|Nivolumab|360 mg intravenously every 3 weeks
15893069|NCT03704168|Device|CRYOABLATION|The SeedNet® System induces freezing and thawing at the tip of the needle. These freezing and thawing processes are based on the Joule-Thomson effect. The unique technology of the SeedNet® System provides extremely rapid freeze and thaw operations. The system's software controls the flow of gases from the gas sources, through the manifold, to the needle and probe tips. The system can immediately switch from the freezing process to the thawing process, after which the needle can be released. This device is an FDA-cleared medical device. This IDE application is to allow for use of the commercially available device in a new clinical indication, namely cryoablation of the submandibular glands.
15893070|NCT03704155|Drug|Botulinum toxin type A|Botulinum Toxin type A The intervention with BoNT-A (Dysport®, Ipsen Biopharmaceutical, USA) was performed in the gastrocnemius and soleus muscles, bilaterally for diplegic children and unilaterally for hemiplegic children.
15893071|NCT03704155|Other|Physical Therapy|"Physiotherapeutic intervention was performed twice a week, with duration of one hour per session for 4 weeks. To maintain standardization of treatment, physiotherapists received a booklet with instructions on what treatment they should do.
~The intervention protocol consisted of:
~Passive stretching of lower limbs,
~Stretching associated with the functionality of the plantar flexor muscles, knee flexors, adductors and hip flexors;
~Strengthening of the antagonist muscles with the application of BoNT-A;
~Static and dynamic balance training;
~Up and down stairs;
~Functional walking training, prioritizing the initial contact of the heel and active and passive dorsiflexion."
15893072|NCT03704142|Device|Sound World Solutions CS50+|Participants will be tested using the Sound World Solutions CS 50+ hearing devices.
15893073|NCT03704142|Device|Tweak Focus|Participants will be tested using the Tweak Focus hearing devices.
15893074|NCT03704142|Device|IQ Earbuds|Participants will be tested using the IQ Earbuds hearing devices.
15893075|NCT03704142|Device|Bose Hearphones|Participants will be tested using the Bose Hearphones hearing devices.
15893076|NCT03704129|Other|Tutor|The participants will access the practical training, during which each participant will be followed by a tutor who will interactively explain, using a healthy volunteer, how to perform the ultrasound scan of the diaphragm. The ultrasound will be performed on a healthy volunteer first by the tutor and then by the participants. During the exercise, each individual learner will be supervised by the tutor himself.
15893077|NCT03704116|Behavioral|Expedition|On a laptop computer participants work on simulated daily life activities including packing for a trip, navigating a transit system, and learning at museum attractions. The intervention increases difficulty as participants accomplish goals. We are testing the effects of this performance challenge on executive function measures.
15893078|NCT03704103|Other|iSage|The provider will choose a treatment algorithm within the iSage app and set the parameters to make insulin dose adjustments no less frequently than every 7 days. The patient is instructed to perform daily fasting glucose measurements and follow the app's recommendations for insulin adjustment.
15893079|NCT03704090|Behavioral|Occupational therapy intervention|Prevention of postoperative delirium by occupational therapy intervention
15893080|NCT03704090|Behavioral|Standard non-pharmacological prevention intervention|Prevention of postoperative delirium using standard non-pharmacological prevention measures
15893081|NCT03704077|Biological|Relatlimab + Nivolumab|Specified dose on specified days
15893082|NCT03704077|Biological|Nivolumab|Specified dose on specified days
15893083|NCT03704077|Drug|Paclitaxel|Specified dose on specified days
15893084|NCT03704077|Drug|Ramucirumab|Specified dose on specified days
15893085|NCT03704064|Behavioral|Stigma-Reduction Intervention|Session topics will be based on those tested in a previous pilot study, including: psychoeducation about weight and weight stigma; challenging myths and cognitive distortions related to weight; strategies for coping with instances of stigma; and increasing empowerment and body esteem. The effects of weight stigma on health behaviors will be discussed, and sessions will focus specifically on helping participants overcome stigma-related barriers to physical activity. For example, they will be given strategies to cope with anticipated stigma while exercising in public spaces (e.g., while walking), as well as to challenge self-critical beliefs (e.g., that they are lazy) which may otherwise lead them to avoid exercising. These concrete strategies, along with reducing WBI and improving self-confidence, are intended to increase participants' self-efficacy for and engagement in physical activity.
15893086|NCT03704064|Behavioral|Behavioral Weight Loss (BWL)|This intervention will be based on the Diabetes Prevention Program. A diet of 1200-1499 calories per day will be prescribed for participants < 250 lb, and 1500-1800 for those ≥ 250 lb. Participants will be instructed to eat a balanced deficit diet. Session topics during the first 20 weeks will include self-monitoring, stimulus control, social support, portion sizes, and goal-setting. Those during weeks 21-72 will focus on skills required for weight loss maintenance and relapse prevention. Physical activity will be begin with a prescription of 60 min/wk, and will gradually progress by 10 minutes over 2-4 week intervals until achieving 150 min/wk by week 20, 200 min/wk by week 46, and 250 min/wk by week 72. Participants will be instructed to spread the activity equally across at least 5 days in bouts that are >10 minutes in duration. Moderate intensity will be prescribed with an emphasis on walking; the vast majority of our research participants self-select this form of activity.
15893087|NCT03704051|Behavioral|Mode of Feeding (breastfeeding versus bottle-feeding|Infants will be breastfed during one lab visit and bottle-fed (with expressed breast-milk) during the other.
15893088|NCT03704038|Procedure|PEEP level|Patients will have variable PEEP levels and will be monitored
15893089|NCT03704025|Behavioral|Current guidelines rehabilitation|Exercise training intervention is six months and includes four to five aerobic and two strength training session a week according to American Heart Association guidelines for coronary artery disease patients. All the patients will have a detailed and personalized training diary.
15893090|NCT03704025|Behavioral|Mobile device guided rehabilitation|Exercise training intervention is six months and includes four to five aerobic and two strength training session a week according to American Heart Association guidelines for coronary artery disease patients. Study group will have virtual glasses or mobile device to motivate and control exercise training program.
15893091|NCT03704012|Behavioral|Protocol of massage therapy and kinesiotherapy|Infants received massage and kinesiotherapy, applied by parents, twice a day; 15 minutes each.
15893092|NCT03703999|Device|Type 1 diabetic patients freestyle libre|patients selected to use freestyle libre
15893141|NCT03703583|Other|There is no intervention in this observational study.|There is no intervention in this observational study.
15893093|NCT03703973|Diagnostic Test|Neuropsychology test|We do the neuropsychological tests, Mini-Mental score examination (MMSE) and olfaction test 1 day before (baseline) and 1 week,3 months,1 year and 3 years after surgery without safety issue.
15893094|NCT03703960|Other|hypnotic analgesia|classic three-step hypnosis procedure (induction, trance and return to consciousness).
15893095|NCT03703960|Other|music|calm music conducive to relaxation
15893096|NCT03703908|Drug|CCX140-B|Orally administered tablet
15893097|NCT03703895|Drug|Topical AFX5931|Active Comparator, Topical AFX5931, a medication combining a small, potent anti-inflammatory molecule.
15893098|NCT03703895|Drug|Topical Placebo|Placebo Comparator, Topical Placebo.
15893099|NCT03703882|Drug|Edasalonexent|100 mg/kg/day
15893100|NCT03703882|Drug|Placebo|Placebo
15893101|NCT03703869|Drug|Insulin glargine (U300)|"Pharmaceutical form: Solution for injection
~Route of administration: Subcutaneous injection"
15893102|NCT03703856|Drug|Memantine|"Phase 1 will test the acute effects of memantine (20 mg po) vs. placebo (PBO) on early auditory information processing measures in 88 carefully characterized patients with mild-to-moderate severity AD who are not currently taking AD medications. From this challenge test, a set of early auditory information processing memantine sensitivity measures will be derived for each patient. In Phase 2, all patients will begin an open-label trial of memantine monotherapy, titrated to 10 mg bid, with outcome measures collected after 8, 16 and 24 weeks of treatment. Medication adjustments are not restricted, and response heterogeneity is anticipated."
15893103|NCT03703856|Drug|Placebo|"Phase 1 will test the acute effects of memantine (20 mg po) vs. placebo (PBO) on early auditory information processing measures in 88 carefully characterized patients with mild-to-moderate severity AD who are not currently taking AD medications. From this challenge test, a set of Early auditory information processing P memantine sensitivity measures will be derived for each patient. In Phase 2, all patients will begin an open-label trial of memantine monotherapy, titrated to 10 mg bid, with outcome measures collected after 8, 16 and 24 weeks of treatment. Medication adjustments are not restricted, and response heterogeneity is anticipated."
15893104|NCT03703843|Device|ARTUS MONO|Temporarily implant and activation of the medical device
15893105|NCT03703830|Device|Cerebellar transcranial direct current stimulation|Cerebellar transcranial direct current stimulation (ctDCS) will be applied during 25 minutes at 2 mA of intensity. Anodal electrode will be positioned 1 cm below inion and cathodal electrode at right deltoid muscle.
15893106|NCT03703830|Other|Treadmill locomotor training|The Treadmill Locomotor Training (TLT) will be performed through speed and step length progression protocol for 25 minutes and combined to ctDCS
15893107|NCT03703830|Device|Sham Cerebellar transcranial direct current stimulation|Sham Cerebellar transcranial direct current stimulation (ctDCS sham) will be applied during 30 seconds at 2 mA of intensity. Anodal electrode will be positioned 1 cm below inion and cathodal electrode at right deltoid muscle. However, subjects will keep the placement of electrodes for 25 minutes to ensure stimulation's masking.
15893108|NCT03703791|Biological|AR101|AR101 powder
15893109|NCT03703778|Procedure|Androgen deprivation therapy - bilateral orchidectomy|Androgen deprivation therapy (ADT) is a kind of hormone therapy for prostate cancer. The goal is to reduce levels of male hormones, called androgens, in the body, or to stop them from affecting prostate cancer cells. It can be surgical, i.e. bilateral orchidectomy, or medical, i.e. GnRH agonist or GnRH antagonist.
15893110|NCT03703778|Drug|Androgen deprivation therapy - GnRH agonist|Androgen deprivation therapy (ADT) is a kind of hormone therapy for prostate cancer. The goal is to reduce levels of male hormones, called androgens, in the body, or to stop them from affecting prostate cancer cells. It can be surgical, i.e. bilateral orchidectomy, or medical, i.e. GnRH agonist or GnRH antagonist.
15893111|NCT03703778|Drug|Androgen deprivation therapy - GnRH antagonist|Androgen deprivation therapy (ADT) is a kind of hormone therapy for prostate cancer. The goal is to reduce levels of male hormones, called androgens, in the body, or to stop them from affecting prostate cancer cells. It can be surgical, i.e. bilateral orchidectomy, or medical, i.e. GnRH agonist or GnRH antagonist.
15893112|NCT03703765|Device|lower limb volume estimation|"The 3D scanner system is a three-dimensional measurement system.
~It allows to evaluate the volume of the lower limbs in order to quantify the evolution of the edema of the lower limbs in the venous pathology in pre and post therapeutic technique.
~It is a non-invasive, easily accepted, non-invasive, non-invasive technique that minimizes discomfort."
15893113|NCT03703752|Diagnostic Test|Multi-detector CT scan|This is a diagnostic radiological test to diagnose the IH and evaluate the clinical condition of IH
15893114|NCT03703739|Dietary Supplement|Reference meal 1|1 ml Ferrous sulfate solution (4mgFe/ml) was added in cooked comercial Rice Prior to served to participant. The meal served with 30 g mixed vegetable Sauce and 300 ml nanopure water
15893115|NCT03703739|Dietary Supplement|Reference 2|1 ml Ferrous sulphate solution (4mgFe/ml) was added in cooked comercial Rice Prior to served to participant. The meal served with 30 g bean Sauce and 300 ml nanopure water
15893116|NCT03703739|Dietary Supplement|Test meal A|"Fortified extruded Rice was mixed with Commercial Rice (mixing Ratio: 1:100) The meal served with 30 g vegetable Sauce and 300 ml nanopure water.
~** composition of extruded Rice: Ferric pyrophosphate, zinc oxide and ethylenediaminetetraacetic acid"
15893117|NCT03703739|Dietary Supplement|Test meal B|"Fortified extruded Rice was mixed with Commercial Rice (mixing Ratio: 1:100) The meal served with 30 g vegetable Sauce and 300 ml nanopure water.
~** composition of extruded Rice: Ferric pyrophosphate, zinc sulfate and ethylenediaminetetraacetic acid"
15893118|NCT03703739|Dietary Supplement|Test meal C|"Fortified extruded Rice was mixed with Commercial Rice (mixing Ratio: 1:100) The meal served with 30 g vegetable Sauce and 300 ml nanopure water.
~** composition of extruded Rice: Ferric pyrophosphate, zinc sulfate, citric acid and trisodium Citrate."
15893119|NCT03703739|Dietary Supplement|Test meal D|"Fortified extruded Rice was mixed with Commercial Rice (mixing Ratio: 1:100) The meal served with 30 g vegetable Sauce and 300 ml nanopure water.
~** composition of extruded Rice: Ferric pyrophosphate, zinc sulfate and sodium pyrophosphate."
15893120|NCT03703739|Dietary Supplement|Test meal E|"Fortified extruded Rice was mixed with Commercial Rice (mixing Ratio: 1:100) The meal served with 30 g bean Sauce and 300 ml nanopure water.
~** composition of extruded Rice: Ferric pyrophosphate, zinc sulfate, citric acid and trisodium Citrate."
15893142|NCT03703570|Drug|KW-6356|Oral administration
15893143|NCT03703570|Drug|Placebo|Oral administration
15893121|NCT03703726|Dietary Supplement|Reference meal|50 g of Commercial Rice (Jasmin Rice) (dry weight) was cooked and 4 mg iron from Ferrous sulphate was added Prior to give to participants. Rice meal consumed with mixed vegetable Sauce.
15893122|NCT03703726|Dietary Supplement|Test meal A|"Commercial Rice (Jasmin Rice) was mixed with iron fortified extruded rice co-fortified with zinc sulfate, Rice meal consumed with mixed vegetable Sauce.
~Cold temperature extruding process (30-40 C°) was used to produce the extruded rice."
15893123|NCT03703726|Dietary Supplement|Test meal B|"Commercial Rice (Jasmin Rice) was mixed with iron fortified extruded rice co-fortified with zinc sulfate, Rice meal consumed with mixed vegetable Sauce.
~Warm temperature extruding process (60-70 C°) was used to produce the extruded rice"
15893124|NCT03703726|Dietary Supplement|Test meal C|"Commercial Rice (Jasmin Rice) was mixed with iron fortified extruded rice co-fortified with zinc sulfate, Rice meal consumed with mixed vegetable Sauce.
~Hot temperature extruding process (80-100 °C) was used to produce the extruded rice."
15893125|NCT03703726|Dietary Supplement|Test meal D|"Commercial Rice (Jasmin Rice) was mixed with iron fortified extruded rice co-fortified with zinc sulfate,citric acid and trisodium Citrate. Rice meal consumed with mixed vegetable Sauce.
~Cold temperature extruding process (30-40 C°) was used to produce the extruded rice."
15893126|NCT03703726|Dietary Supplement|Test meal E|"Commercial Rice (Jasmin Rice) was mixed with iron fortified extruded rice co-fortified with zinc sulfate,citric acid and trisodium Citrate. Rice meal consumed with mixed vegetable Sauce.
~warm temperature extruding process (60-70 C°) was used to produce the extruded rice."
15893127|NCT03703726|Dietary Supplement|Test meal F|"Commercial Rice (Jasmin Rice) was mixed with iron fortified extruded rice co-fortified with zinc sulfate,citric acid and trisodium Citrate. Rice meal consumed with mixed vegetable Sauce.
~Hot temperature extruding process (80-100 C°) was used to produce the extruded rice."
15893128|NCT03703713|Drug|Sodium chloride|Treatment with Sodium chloride
15893129|NCT03703700|Drug|Zishen Yutai Pill|Patients who undergo the long-term protocol will start taking Zishen Yutai Pill on the day of pituitary suppression, 5g three times a day (Stopping on the first 1-4 days of menstruation), and patients who undergo the antagonist protocol will start taking Zishen Yutai Pill on the 19th to 23rd day of the previous menstruation cycle, 5g three times a day (Stopping on the first 1-4 days of menstruation). The drug will be taken till 2 weeks after transplantation. If the test result is confirmed as biochemical pregnancy (HCG>50 IU/L), patients continue to take pills till 3 weeks after the clinical pregnancy determined by the ultrasound. If it is determined that the pregnancy test is negative, stop the drug.
15893130|NCT03703700|Drug|Placebo|Patients who undergo the long-term protocol will start taking Placebo on the day of pituitary suppression, 5g three times a day (Stopping on the first 1-4 days of menstruation), and patients who undergo the antagonist protocol will start taking Placebo on the 19th to 23rd day of the previous menstruation cycle, 5g three times a day (Stopping on the first 1-4 days of menstruation). The drug will be taken till 2 weeks after transplantation. If the test result is confirmed as biochemical pregnancy (HCG>50 IU/L), patients continue to take pills till 3 weeks after the clinical pregnancy determined by the ultrasound. If it is determined that the pregnancy test is negative, stop the drug.
15893131|NCT03703687|Behavioral|Gratitude intervention|"The intervention will be proposed to both the patient and the caregiver and consists of two steps: the gratitude letter and the gratitude visit. In the gratitude letter, the individual writes about his feelings of gratitude through a letter, based on a written instruction. The gratitude visit consists of an extension of the gratitude letter where the writer of the letter (i) either personally reads the letter to the beneficent or (ii) gives it to him and asks him to read it in his presence or later in his absence."
15893132|NCT03703674|Drug|GCSF|Granulocyte-colony stimulating factors (G-CSF)
15893133|NCT03703661|Procedure|Needle-Aspirated Negative Pressure Dressing|dressing consisting of Needle-Aspirated Negative Pressure dressing with gauze and adhesive/occlusive dressing, placed over wound after primary closure
15893134|NCT03703661|Procedure|Control|dressing consisting of gauze and adhesive/occlusive dressing, placed over wound after primary closure
15893135|NCT03703648|Radiation|Radiotherapy (curative) for head and neck cancer|Curative intent radiotherapy for head and neck cancer. Doses will be prescribed by an independent Clinical Oncology team. There will be no alteration or experimentation of radiotherapy dosage
15893136|NCT03703635|Device|intracranial balloon angioplasty|This group will receive intracranial balloon angioplasty and aggressive medical care including Aspirin 100mg once/day during the follow-up period, Clopidogrel 75mg once/day for at least 90 days, Atorvastatin 20mg once/day as the situation requires and risk factors management including blood pressure to maintain 130-140/90-100 mmHg and LDL lower than 70 mg/dl.
15893137|NCT03703622|Behavioral|Video-debriefing with standard HBB training compared with standard HBB training only|"We will use the AAP training curriculum for the HBB 2nd edition through out the training and course assessments pre-and post- training and during follow-up period.
~Both intervention arms will a 2 days training consisting of: lectures, neonatal resuscitation demonstrations using NeoNatali mannequin, and practical skills s sessions. Pre- and post-tests knowledge (MCQs) and skills (bag mask ventilation, OSCE A, & OSCE B) will be given to all participants.
~In the intervention arm, in addition to standard training, participants will work in teams of three (birth attendant, mother, and an assistant) to perform different HBB case scenarios. These will be filmed and used for subsequent debriefing after each case scenarios. After all participants in the intervention have had the opportunity to participate in the debriefing, then a post test is done to assess performance.
~Analysis is done to compare the intervention and control arms performances."
15893138|NCT03703609|Behavioral|Tele-yoga|Participants will get a 60 min tele-yoga session biweekly led by a certified medical yoga instructor via live videoconference link on the participants tablet. Each participant will perform a total of 20-24 yoga instructor-led sessions over a 12-week period. A session will contain 10 min breathing exercises, 40 min of yoga and 10 min relaxation/meditation. Before and at the end of each session, participants can discuss their experiences or ask questions to the instructor online. The tablet also includes an app with instructions (text, pictures, and sound files) for yoga positions, breathing and meditation. Participants are encouraged to practice yoga at home individually with one goal of one session a day for a minimum of 10 minutes.
15893139|NCT03703596|Drug|Anlotinib Hydrochloride|Anlotinib (12mg QD PO d1-14, 21 days per cycle)
15893140|NCT03703596|Drug|Docetaxel|Docetaxel (75mg/m2 IV d1, 21 days per cycle)
15893457|NCT03700970|Drug|Regular bupivacaine|20mL of 0.25% bupivacaine injected on each side.
15893144|NCT03703557|Diagnostic Test|Sorbstar®|Thermodesorption method coupled with full two-dimensional gas chromatography and mass spectrometry.
15893145|NCT03703557|Diagnostic Test|Odour sampling|Analyzed by the dogs of Curie Institute at the training centers
15893146|NCT03703544|Other|High glycemic index|Wheat yellow noodle, glutinous rice, tea with sucrose, biscuits, jelly made with sucrose and teriyaki chicken rice.The foods provided have been tested as high glycemic index. Participants' blood glucose will be monitored using the Continuous Glucose Monitor.
15893147|NCT03703544|Other|Low glycemic index|Beta-glucan yellow noodle, basmati rice, tea with isomaltulose, biscuits, jelly made with isomaltulose and mung bean noodles.The foods provided have been tested as low glycemic index.Participants' blood glucose will be monitored using the Continuous Glucose Monitor.
15893148|NCT03703531|Procedure|Cardiopulmonary resuscitation|CPR performed because of out-of-hospital cardiac arrest
15893149|NCT03703518|Other|Mixed reality|"This group received 6 exercise sessions over 3 weeks, 2 days/week with an interval of 48 to 72 hours between sessions, using the Microsoft Hololens Roboraid game. The duration of the sessions will be 10 minutes."
15893150|NCT03703518|Other|Conventional exercise group|This group received 6 exercise sessions over 3 weeks, 2 days/week with an interval of 48 to 72 hours between sessions. This program will consist on stabilisation exercises of the cervical region, in neck deep flexors and neck deep extensors muscles to provide them with strength and resistance
15893151|NCT03703505|Drug|AG-348|120 milligrams (mg) oral capsule, single dose, contains 100 microcuries (μCi) of radio labelled [14C]AG-348.
15893152|NCT03703505|Drug|[13C6]AG-348|IV microdose of approximately 100 micrograms (mcg), single dose.
15893153|NCT03703492|Drug|(18F)FES|"18F-FES is an investigational new drug which will be used for this study. For complete information, please refer to the Investigator's Brochure: [18F]Fluoroestradiol: An investigational positron emission tomography (PET) radiopharmaceutical for injection, intended for use as an in vivo diagnostic for imaging estrogen receptors in tumors"
15893154|NCT03703492|Drug|Gadobenate dimeglumine|Gadolinium-based intravenous contrast agent used for the MRI portion of this study
15893155|NCT03703479|Other|autologous blood clot made from the patient own clot without any additive|advanced Platelet-rich fibrin clot is made from venous blood withdrawn from the patient
15893156|NCT03703466|Drug|Abemaciclib|Administered orally.
15893157|NCT03703453|Device|ER-REBOA catheter|The ER-REBOA™ catheter is a device that has been gaining increased use in the setting of severe trauma for the purposes of stopping intra-abdominal hemorrhage. The catheter is advanced through a femoral artery sheath into the aorta, where a balloon at its tip is inflated, occluding all distal blood flow (and stopping any hemorrhage while the patient can be prepared for definitive operative intervention).
15893158|NCT03703440|Other|Active arm|≥3 group education sessions in addition to usual diabetes care, every 3 months for 12 months
15893159|NCT03703440|Other|Control arm|Usual diabetes care, every 3-month for 12 months
15893160|NCT03703427|Drug|Capecitabine, Oral, 500 Mg|1250mg/m2，d1-d14，q3w
15893161|NCT03703427|Drug|Vinorelbine Tartrate Oral|60mg/m2，d1；d8；q3w
15893162|NCT03703414|Diagnostic Test|Fecal microbiota composition analysis and blood cytokine level analysis|Fecal microbiota composition analysis and blood cytokine level analysis
15893163|NCT03703401|Diagnostic Test|Hysterosalpingo-contrast-sonogram|A contrast ultrasound scan to examine fallopian tube pathology and blockage
15893164|NCT03703388|Dietary Supplement|Arctigenin|Arctigenin capsule
15893165|NCT03703375|Drug|Azacitidine|Azacitidine
15893166|NCT03703375|Drug|Romidepsin|Romidepsin
15893167|NCT03703375|Drug|Gemcitabine|Gemcitabine
15893168|NCT03703362|Other|Resistance training|30 supervised training-sessions over 12 weeks
15893169|NCT03703349|Drug|Magnesium Sulfate|Magnesium sulfate will be prescribed by the surgeon / Anesthesiologist and will be taken orally by the patient for the 3 days preceding the surgery
15893170|NCT03703349|Drug|Placebo Oral Tablet|Placebo for Magnesium
15893171|NCT03703336|Biological|ROTAVIN (liquid formulation)|Live attenuated human rotavirus vaccine containing ≥ 2x10^6 plaque forming units (PFU) of strain G1P[8] per dose of 2 mL.
15893172|NCT03703336|Biological|ROTAVIN-M1 (frozen formulation)|Live attenuated human rotavirus vaccine containing ≥ 2x10^6 PFU of strain G1P[8] per dose of 2 mL.
15893173|NCT03703323|Other|Rotative thromboelastometry analysis|Obtaining blood sample (one tube of blood)
15893174|NCT03703310|Drug|Patidegib Topical Gel, 2%|Patidegib Topical Gel, 2%
15893175|NCT03703310|Drug|Patidegib Topical Gel, Vehicle|Patidegib Topical Gel, Vehicle
15893176|NCT03703297|Drug|Durvalumab|Durvalumab IV (intravenous infusion)
15893177|NCT03703297|Drug|Tremelimumab|Tremelimumab IV (intravenous infusion)
15893178|NCT03703297|Other|Placebo|Placebo IV (intravenous infusion)
15893179|NCT03703284|Other|Treatments to reduce intracranial pressure|Drugs such as mannitol, glycerin fructose, etc and/or surgery
15893180|NCT03703271|Drug|Methotrexate|single-agent 5-day methotrexate, two weeks a cycle
15893181|NCT03703271|Procedure|hysteroscopic repeat curettage|Study of Hysteroscopic Repeat Curettage as the First-line Treatment in Low-risk Postmolar Gestational Trophoblastic Neoplasia
15893182|NCT03703258|Behavioral|App-based intervention|A app-based cognitive-behavioral intervention to prevent the development of PTSD and high-risk drinking in recently-victimized adults
15893183|NCT03703245|Other|Sodium bicarbonate|Experimental dentifrice containing 67% w/w sodium bicarbonate in 3 studies and additionally 62% w/w sodium bicarbonate in 3 studies.
15893184|NCT03703245|Other|Control Dentifrice|Negative control dentifrice containing 0% w/w sodium bicarbonate
15893185|NCT03703232|Device|Investigational prosthetic foot|Individuals will complete 2-4 weeks of community walking with the investigational foot and compare to their regular prosthetic foot.
15893186|NCT03703219|Other|Mothers Touch Program|Combination of diet, massage, body binding methods along with 40 days of rest following the traditional way of delivering
15893187|NCT03703206|Drug|ultrasound guided injection of local anesthetic between the popliteal artery and the capsule of the knee (iPACK)|nerve block for posterior knee pain after a TKA.
15893188|NCT03703193|Other|Dry Needling|A single session of modulatory interventions combined with a single session of dry needling into the shoulder muscles which active trigger points will reproduce the shoulder pain symptoms.
15909887|NCT03573947|Drug|Ipilimumab|1 mg/kg intravenously over 30 minutes
15893189|NCT03703193|Other|Physical Therapy|A single session of modulatory interventions targeting modulation of central nervous system.
15893190|NCT03703167|Drug|Ibrutinib|Oral ibrutinib will be given between days 1 and 28 of each 28-day cycle and will be continued daily after completion of rituximab and lenalidomide. The starting dose of ibrutinib is 560 mg/day (dose level 1) and (dose level 2 ibrutinib: 840 mg daily).
15893191|NCT03703167|Drug|Lenalidomide|Oral lenalidomide will be given between days 1 and 21 of each 28-day cycle for a maximum of 12 cycles. The starting dose of lenalidomide is 10 mg/day (dose level 1 & 2) lenalidomide: 15 mg daily (dose level 3) and lenalidomide: 20 mg daily (dose level 4).
15893192|NCT03703167|Drug|Rituximab|Intravenous rituximab (500mg/m2) will be given on day 1 of all cycles (+/- 3 days), for up to 6 cycles.
15893193|NCT03703154|Drug|Envarsus|Patients will then be randomized in the ratio of 2:1 with 20 being in the study arm and 10 in the control arm. Envarsus will be prescribed by the transplant team per conversion guidelines. The transplant team will monitor drug levels, per the dosing guidelines.
15893194|NCT03703154|Drug|Tacrolimus|The patient's physician will prescribe drug according to standard practice.
15893195|NCT03703141|Dietary Supplement|sucralose 48 mg (splenda)/day for ten weeks|volunteers will take sucralose or placebo daily for 70 days
15893196|NCT03703115|Behavioral|Fasting|No food for 14 -16 hours with water intake and non caloric beverages then eating balanced meals over 8 to 10 hours
15893197|NCT03703102|Drug|KHK4083|Anti-OX40 Monoclonal Antibody KHK4083
15893198|NCT03703102|Drug|Placebo|Matching placebo
15893199|NCT03703089|Drug|Gemcitabine|Administered by intravenous infusion over 30 minutes.
15893200|NCT03703089|Drug|nab-paclitaxel|Administered by intravenous infusion over 30-40 minutes.
15893201|NCT03703063|Drug|Gemcitabine|Administered by intravenous infusion over 30 minutes.
15893202|NCT03703063|Drug|nab paclitaxel|Administered by intravenous infusion over 30-40 minutes.
15893203|NCT03703063|Drug|Onivyde|Administered by intravenous infusion over 90 minutes.
15893204|NCT03703063|Drug|Leucovorin|Administered by intravenous infusion over 30 minutes.
15893205|NCT03703063|Drug|5-fu|Administered by intravenous infusion over 46 hours.
15893206|NCT03703050|Drug|Nivolumab cohort 1|Induction: nivolumab 3 mg/kg (maximal unitary dose: 240 mg) iv Q2W until CR Evaluation of response as defined below, including biopsy in case of residual masses at Week 24 Maintenance: nivolumab 3 mg/kg (maximal unitary dose: 240 mg) Q4W Total duration of treatment (induction + maintenance) = 24 months
15893207|NCT03703050|Drug|Nivolumab cohort 2|Induction: nivolumab 3 mg/kg iv Q2W for 4 doses (Wk0, Wk2, Wk4 and Wk6) Maintenance: nivolumab 3 mg/kg Q4W, for 25 doses, starting at Week 8 (14 days after the last induction dose) Total duration of treatment (induction + maintenance) = 24 months
15893208|NCT03703037|Diagnostic Test|Ultrasound and Doppler ultrasound|Assessment of fetal cerebral and maternal uterine pulsatility index using Doppler ultrasound. Measurement of amniotic fluid index according to four-quadrant technique.
15893209|NCT03703024|Dietary Supplement|Raspberry Leaf Extract|Eligible subjects will be scheduled for an initial visit. The study will involve 3 visits over a 12 to 13-week period. One capsule to be taken every morning over a 12-13 week period.
15893210|NCT03703024|Dietary Supplement|Placebo|Delivered in a capsule
15893211|NCT03703011|Device|Accelerometers positioned at the wrinkle, the hip, and the ankle|Accelerometers are positioned at the wrinkle, the hip, and the ankle. The subject stands and walks 10 meters, followed up by a physiotherapist in the physiotherapy area. The accelerometers are triggered by a smartphone. The protocol is filmed (without the face), and 2 physicians will watch the film and count the steps blind to the results of the accelerometers (and blind to each-other steps counts)
15893212|NCT03702985|Radiation|Radiation|Pelvic Radiation: 50Gy/25Fx
15893213|NCT03702985|Drug|Capecitabine|625mg/m2 bid Monday-Friday per week
15893214|NCT03702985|Drug|Irinotecan|80mg/m2 (UGT1A1*28 6/6) or 65mg/m2 (UGT1A1*28 6/7)
15893215|NCT03702985|Drug|Amifostine|400mg/m2 per week
15893216|NCT03702959|Drug|Betamethasone|Corticosteroids
15893217|NCT03702946|Other|oxytocin in abdominal myomectomy|Women were divided into two groups randomly. In the study group 30 Units of oxytocin in 1000 ml normal saline were given during surgery, at the rate of 15units/hour. In control group, pure normal saline was given
15893218|NCT03702933|Dietary Supplement|D-serine|dosage
15893219|NCT03702920|Biological|SMT + PE-A 5%|Plasma exchange treatment (PE-A 5%) will be performed using 5% albumin solution (Albutein 5%). Fresh frozen plasma will be given to prevent coagulopathy. IVIGs will be administered intravenously to prevent the development of hypogammaglobulinemia and infection.
15893220|NCT03702920|Other|Standard Medical Treatment|Standard medical treatment according to the institution's standard practice
15893221|NCT03702894|Drug|Clavamox|Clavamox, Film-coated Tablets, 875 mg + 125 mg, manufactured by Pharmtechnology LLC, Belarus
15893222|NCT03702894|Drug|Augmentin®|Augmentin®, Film-coated Tablets, 875 mg + 125 mg, marketed by GlaxoSmithKline Trading CJSC, Russia
15893223|NCT03702881|Device|Bonded Spurs associated with posterior build-ups|Twenty-five patients will be treated with bonded spurs associated with posterior build-ups. The cervical portion of the palatal surfaces of the maxillary incisors and the incisal portion of the lingual surfaces of the mandibular incisors will be pumiced, rinsed, dried, and acid etched with 37% phosphoric acid. The etched surfaces will be subsequently rinsed and carefully dried. Then, the spurs will be bonded using Transbond primer/adhesive. The positions for the spurs will be chose to prevent possible future occlusal interferences The spurs will be sharpened with a carborundum disk before bonding. In addition, posterior build-ups (resin blocks) will be cemented on the functional cusps of all maxillary posterior teeth. The treatment time will be 12 months. After this time, the posterior build ups will be removed and the bonded spurs will be maintained for 12 months more, as active retention.
15893224|NCT03702881|Device|Conventional bonded spurs|Twenty-five patients will be treated only with bonded spurs. The bonding of the spurs will follow the same protocol described for the experimental group. The treatment time will be 12 months. After this time, the bonded spurs will be maintained for 12 months more, as active retention.
15893225|NCT03702855|Drug|Tetrabenazine Tablets 25 mg|
15893270|NCT03702517|Device|traditional physiotherapy|strengthening exercise, balance training and gait training
15893337|NCT03701867|Other|Metabolic Flexibility Tests|Energy Metabolism, Oxygenation, Body Composition, Blood Samples
15893226|NCT03702842|Device|Soterix Medical tsDCS stimulator|tsDCS will be delivered to the lumbar region of the spinal cord with electrodes placed over the low back and abdomen. The electrodes will be secured with a large elastic bandage so that stimulation can be applied for up to 30 minutes during locomotor training with a harness attached to the ceiling for safety. A physical therapist will supervise the session.
15893227|NCT03702842|Other|Locomotor training|Participants will complete 16 sessions of locomotor training (4 times per week for 4 weeks). This involves walking on a treadmill for up to 30 minutes with a harness attached to the ceiling for safety, followed by 10 minutes of overground walking training; with physical assistance as needed.
15893228|NCT03702829|Drug|Inotersen|Open Label Study
15893229|NCT03702816|Drug|GE180 PET Scan|GE180 PET Scan
15893230|NCT03702803|Dietary Supplement|Galphimia glauca standardized extract|Each patient will be administered with a capsule once a day (in the morning), for 10 weeks. A capsule contains the standardized extract of Galphimia glauca corresponding to 0.374 mg of Galphimine-B
15893231|NCT03702803|Drug|alprazolam 1mg|Each patient will be administered once a day (in the morning) for 10 weeks. A capsule contains 1 mg Alprazolam
15893232|NCT03702777|Drug|ASP8302|Oral Capsule
15893233|NCT03702777|Drug|Placebo|Oral Capsule
15893234|NCT03702764|Diagnostic Test|CCTA|128-multislice CT coronary angiography and complex atherosclerotic plaque analysis, with the use of CT imaging post-processing techniques.
15893235|NCT03702751|Procedure|Adhesive tape|will be subjected to skin repair after episiotomy with skin adhesive tape.
15893236|NCT03702751|Procedure|Continuous subcuticular skin suturing|will be subjected to skin repair after episiotomy with the currently traditional method for episiotomy repair by continuous absorbable subcuticular suture.
15893237|NCT03702738|Drug|N-acetyl cysteine|NAC is listed by WHO as an essential medicine for its use in paracetamol (acetaminophen) poisoning, in which it protects against fatal liver injury. It also reduces the viscosity of sputum, thereby serving as an expectorant.
15893238|NCT03702725|Drug|Ibrutinib|Ibrutinib administered on every day of each 28 day cycle. Dosage depends on timing of patient enrollment and dosage tolerance by patients already enrolled.
15893239|NCT03702725|Drug|Lenalidomide|Lenalidomide administered on days 1-21 of each 28 day cycle. Dosage depends on findings from Dose Escalation phase.
15893240|NCT03702725|Drug|Dexamethasone|Dexamethasone administered on days 1, 8, 15, and 22 of every 28 day cycle. Dosage depends on findings from Dose Escalation phase.
15893241|NCT03702712|Behavioral|Aerobic Exercise and Relaxation|This intervention will combine 20 minutes of moderate aerobic exercise followed by 20 minutes of mindfulness training.
15893242|NCT03702712|Behavioral|Aerobic Exercise Only|This intervention will combine 20 minutes of moderate aerobic exercise followed by 20 minutes of quiet rest.
15893243|NCT03702712|Behavioral|Relaxation Only|This intervention will combine 20 minutes of mindfulness-based relaxation training followed by 20 minutes of quiet rest.
15893244|NCT03702699|Device|Auricular point detector|This device is only for auricular detection. No additional intervention will be delivered.
15893245|NCT03702686|Device|FEEDBACK System|Smart Nipple Shield and Monitor Unit
15893246|NCT03702673|Drug|K-877 CR Tablet A|K-877 Controlled Release Tablet A
15893247|NCT03702673|Drug|K-877 CR Tablet B|K-877 Controlled Release Tablet B
15893248|NCT03702673|Drug|K-877 CR Tablet E|K-877 Controlled Release Tablet E
15893249|NCT03702673|Drug|K-877 IR Tablet|K-877 Immediate Release Tablet
15893250|NCT03702660|Other|GIP(3-30)NH2|Peptide derived from the naturally occuring gut hormone GIP
15893251|NCT03702660|Other|Peripheral venous cannulation|Intravenous access for infusions
15893252|NCT03702660|Other|GLP-1|Peptide infusion
15893253|NCT03702647|Drug|Ropivacaine|30mL of 0.2% Ropivacaine placed in the POEM tunnel
15893254|NCT03702647|Drug|Normal saline|30mL of normal saline placed in the POEM tunnel
15893255|NCT03702634|Behavioral|Spiritual Care Assessment and Intervention (SCAI) framework|The study chaplain will work with the surrogate, using questions in four domains of spiritual care, to assess them and tailor the visit to their specific needs. The study chaplain will then utilize a pre-determined list of spiritual care interventions, and also document observable outcomes that occur at each visit (which are also listed within the SCAI framework).
15893256|NCT03702621|Drug|liposomal Bupivacaine|20mL
15893257|NCT03702621|Drug|Standard Bupivacaine, 0.125%|40mL
15893258|NCT03702621|Drug|bupivacaine, 0.25%|60mL
15893259|NCT03702608|Combination Product|EluNIR Ridaforolimus Eluting Coronary Stent System|"The EluNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising of:
~Stent - a mounted Cobalt Chromium (CoCr) alloy based stent - 38 mm length and 2.75mm, 3.0 mm, 3.5mm, 4.0mm diameter
~Delivery System - Rapid Exchange (RX) Coronary System
~Polymer matrix coating - (PBMA) and CarboSil®
~Ridaforolimus drug"
15893260|NCT03702595|Other|Hip flexors stretching protocol|Stretching protocol of rectus femoris, vastus lateralis and iliopsoas according to Kaltenborn- Evjenth Orthopaedic Manual Therapy Concept (OMT)
15893261|NCT03702582|Drug|Rivaroxaban|Anticoagulant drug that works via direct inhibition of factor Xa. FDA approved for prophylaxis against stroke in non-valvular atrial fibrillation
15893262|NCT03702582|Drug|Warfarin|Anticoagulation drug that works via inhibition of vitamin K dependent clotting factors. FDA approved for prophylaxis against stroke in atrial fibrillation
15893263|NCT03702569|Diagnostic Test|Left ventricular global longitudinal strain measure|Left ventricular global longitudinal strain value measured before and immediately after volume expansion (500mL crystalloid) using speckle tracking images with echocardiography
15893264|NCT03702556|Device|MRI scan|7.0 tesla functional MRI scan
15893265|NCT03702543|Behavioral|SymTrend, Inc.|Use of SymTrend and Apple Health apps with feedback and strategies provided.
15893266|NCT03702530|Biological|3x 50 L3 larvae immunisation with albendazole treatment|Immunisation with 50 Necator americanus L3 larvae at week 0, 3 and 6 with albendazole treatment at week 2, 5 and 8
15893267|NCT03702530|Other|3x placebo immunisation with albendazole treatment|Mock immunisation with water at week 0, 3 and 6 with albendazole treatment at week 2, 5 and 8
15893268|NCT03702530|Biological|2x 50 L3 larvae infection|After (mock) immunisation, infection with 50 Necator americanus larvae at week 13 and 15
15893269|NCT03702517|Device|lateral stair walking exercise|15 minutes of lateral stair walking exercise
15893271|NCT03702491|Drug|Apatinib|Three to four weeks after surgery, the SOX regimen was given palliative adjuvant chemotherapy for 6-8 cycles, then followed by the second cycle combined with the treatment of apatinib mesylate and the monotherapy maintenance of apatinib mesylate
15893272|NCT03702491|Drug|Tegafur|3-4 weeks after operation, 6-8 cycles of adjuvant chemotherapy with simple SOX protocol were given.
15893273|NCT03702478|Other|Questionnaire|No intervention only observational
15893274|NCT03702465|Other|DNA-based dietary intervention|The DNA for all arms of the study will be analysed for pre-determined single nucleotide polymorphisms (SNPs) relevant to metabolism. Participants in the intervention arm, will be provided with a hard-copy of a genetic report, which will explain how their SNPs influence their dietary habits.
15893275|NCT03702465|Other|DNA-based dietary intervention using an app|The DNA for all arms of the study will be analysed for pre-determined single nucleotide polymorphisms (SNPs) relevant to metabolism. Participants in the exploratory arm, will be given personalised DNA-based dietary advice via the DnaNudge App.
15893276|NCT03702465|Other|Control arm|Standard care for pre-diabetic individuals: dietary advice as per the NICE guidelines for individuals who have pre-diabetes.
15893277|NCT03702452|Other|functional rehabilitation nursing program|According to the modified Barthel index score, the patients' function was divided into four parts Level,each level has different kinds of rehabilitation nursing.
15893278|NCT03702452|Other|control group|The rehabilitation were given by the rehabilitation therapist based on the patient's condition, such as, bridge movement,limb passive motion, limb active motion,turn over,sit upw,walk, and so on.
15893279|NCT03702426|Drug|GMCSF|GMCSF 1.5mcg/Kg
15893280|NCT03702426|Drug|Norfloxacin|Tablet Norfloxacin 400 mg
15893281|NCT03702413|Procedure|Endovascular treatment|Acute thrombectomy
15893282|NCT03702400|Drug|Phenylephrine 100 mcg|Phenylephrine at a dose of 100 mcg bolus at a dilution containing 20 mcg / mL of the drug, 5 mL each bolus
15893283|NCT03702400|Drug|Norepinephrine 5 mcg|Norepinephrine at a dose of 5 mcg at dilution containing 1 mcg / mL, 5 mL each bolus
15893284|NCT03702387|Procedure|standard intravenous regional anesthesia (IVRA) with reapplication of esmach|his intervention simply adds one additional step to the standard IVRA procedure: reapplication of the Esmarch bandage after lidocaine has been injected intravenously. Everything else about this experimental procedure is standard of care.
15893285|NCT03702374|Drug|Combined antioxidant therapy|It consists in a tablet with lutein (10 mg), astaxanthin (4 mg), Zeaxanthin (1mg), vitamin C (L-ascorbic acid 180mg), vitamin E (DL-alpha tocopherol 30mg), zinc (zinc oxide 20mg), copper (copper sulfate 1mg), taken once a day for 12 months
15893286|NCT03702374|Other|Placebo|It consists in a capsule with 100mg of magnesium oxide.
15893287|NCT03702361|Drug|VPRIV|VPRIV (Velaglucerase alfa) Long-term enzyme replacement therapy (ERT) for patients with type 1 Gaucher disease.
15893288|NCT03702348|Other|Resistance exercise|Protocol with 5min warm-up exercise and 8 exercises that progress in positioning and resistance based on maximum repetition test. The exercises strengthen both the lower and upper limbs and are intended to simulate activities such as sitting and standing up, climbing stairs, picking up weight ...
15893289|NCT03702335|Behavioral|Dietary Counselling|Intervention group will be given a comprehensive dietary guidance on how to choose healthier options when eating out, as well as how to personally prepare a healthy meals.
15893290|NCT03702322|Behavioral|Voice therapy: respiratory|Abdominal voice onset
15893291|NCT03702322|Behavioral|Voice therapy: glottal closure|Pulling/pushing task
15893292|NCT03702322|Behavioral|Voice therapy: loud|Assertive task
15893293|NCT03702322|Behavioral|Voice therapy: Semiocclusion|Semi-occluded vocal tract
15893294|NCT03702296|Other|Ear plugs and eye masks|Patients in the intervention arm will be provided with ear plugs and eye masks and instructed on the use of these during sleep
15893295|NCT03702283|Other|Penicillin Allergic Risk Stratification Best Practice Alert|Providing best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
15893296|NCT03702270|Other|Penicillin Allergic Risk Stratification Best Practice Alert|Providing best practice information on a patient's penicillin allergy risk and how to manage different levels of risk.
15893297|NCT03702257|Procedure|bronchoscopy.|gDSAs are studied on cryopreserved biopsies obtained during bronchoscopy. The technique is the one described by Visentin J.
15893298|NCT03702244|Diagnostic Test|cCTA with selective FFRct|PRECISE will evaluate whether a precision evaluation strategy that combines contemporary risk stratification using the PROMISE Risk Tool with functional and anatomic non-invasive evaluation with cCTA with selective FFRct can improve outcomes over usual care in stable chest pain patients while safely deferring further testing in low-risk patients and reducing cost overall
15893299|NCT03702231|Biological|Zoster Vaccine Recombinant, Adjuvanted|A series of 2 doses of SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) will be given on a 0- and 3-month schedule by intramuscular injection.
15893300|NCT03702218|Drug|Direct Acting Antivirals|"Patients who are given organ transplants from donors that are Ab positive and NAT negative or Ab positive and NAT positive for Hepatitis C will be treated with direct acting antivirals after transplant if they become NAT+ for hepatitis C.
~Interventions as follows.
~Liver Transplant:
~• Combinations of choice:
~Mavyret (glecaprevir/pibrentasvir) - Genotype 1-6
~Harvoni (ledipasvir/sofosbuvir) + Ribavirin - Genotypes 1, 4, 5, 6; GFR>30
~Epclusa (sofosbuvir/velpatasvir) + Ribavirin - Genotypes 1-6; GFR>30
~Kidney Transplant:
~• Combinations of choice:
~Mavyret (glecaprevir/pibrentasvir) - genotype 1-6
~Harvoni (sofosbuvir/ledipasvir) - genotype 1, 4; GFR>30"
15893301|NCT03702205|Dietary Supplement|Betaine supplementation|Group taking oral betaine supplementation
15893302|NCT03702205|Dietary Supplement|Placebo treatment|Group taking oral supplementation with placebo (starch) in a similar capsule form.
15893303|NCT03702192|Device|novel anticoagulation protocol used in conjunction with the Berlin Heart EXCOR|novel antithrombotic management protocol
15893304|NCT03702179|Drug|Durvalumab|All patients will receive durvalumab (MEDI4736) (1500mg Q4W) in combination with tremelimumab (75 mg IV Q4W) for up to 3 doses/cycles each, unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. If a patient's weight falls to 30kg or below the patient should receive weight-based dosing equivalent to 20 mg/kg of durvalumab Q4W and 1mg/kg tremelimumab Q4W until the weight improves to >30 kg, at which point the patient should start receiving the fixed dosing of durvalumab 1500mg plus tremelimumab 75 mg Q4W.
15893305|NCT03702179|Drug|Tremelimumab|All patients will receive durvalumab (MEDI4736) (1500mg Q4W) in combination with tremelimumab (75 mg IV Q4W) for up to 3 doses/cycles each, unless there is unacceptable toxicity, withdrawal of consent, or another discontinuation criterion is met. If a patient's weight falls to 30kg or below the patient should receive weight-based dosing equivalent to 20 mg/kg of durvalumab Q4W and 1mg/kg tremelimumab Q4W until the weight improves to >30 kg, at which point the patient should start receiving the fixed dosing of durvalumab 1500mg plus tremelimumab 75 mg Q4W.
15893306|NCT03702179|Radiation|Radiotherapy|Radiotherapy at doses of 46 Gy to the minor pelvis and 64-66 Gy to the bladder.
15893307|NCT03702166|Behavioral|Cognitive Processing Therapy (CPT)|CPT is a cognitive behavioral treatment for PTSD consisting of 12 one-hour sessions. CPT is delivered in three phases: education, processing, and challenging.
15893308|NCT03702153|Procedure|Abdominal wall reconstruction|The repair of abdominal wall defects with polypropylene mesh
15893309|NCT03702140|Drug|"Teriparatide, Forteo® or Teribon"|To examine the effects of terimaratide less than 6 months in osteoporosis
15893310|NCT03702127|Device|Transcranial magnetic stimulation|NIBS is applied to the brain.
15893311|NCT03702114|Device|auricular point detection|This device is only for auricular detection. No additional intervention will be delivered.
15893312|NCT03702101|Device|Auricular point detector|This device is only for auricular detection. No additional intervention will be delivered.
15893313|NCT03702075|Other|self-administered program|One session was a session supervised by a physical therapist in the Faculty of Health Sciences. This session took place in groups of three or four people. All participants had to follow the physiotherapist instructions about the correct way to do the exercises with the foam roller or ball and nerve mobilizations of upper limbs.The other two weekly sessions were performed at home, following the instructions given by the physiotherapist in session.
15893314|NCT03702062|Diagnostic Test|6 Minute Walk Test Smart phone Application|The intervention requests participants to user the smart phone application at prescribed frequencies during the follow-up period.
15893315|NCT03702049|Behavioral|Nurse-led Community Health Worker TBI (RN/CHW TBI) program|Homeless adults with TBI will be assigned to this program which includes culturally-sensitive education, case management, and directly observed therapy (DOT) delivery of medication among patients who have been prescribed 3HP (12 weeks treatment for latent TB infection) by a medical provider. For this research, 3HP will be delivered to homeless persons infected with TB on a weekly basis by CHW under the guidance of their RN. The RN/CHW team will also provide case management, including health education and referrals for social services.
15893316|NCT03702036|Drug|molibresib|molibresib 20 mg will be supplied for compassionate use for the identified individual subject.
15893317|NCT03702023|Drug|Acetaminophen|Intervention group will receive 1000 mg of acetaminophen
15893318|NCT03702023|Drug|Placebo Oral Tablet|Control group will be given a placebo capsule.
15893319|NCT03702010|Device|spinal cord stimulation conventional|If the patient has been assigned to the branch of the CME control group, after mapping the search for the pain zone, the neurostimulator is programmed to conventional stimulation.
15893320|NCT03702010|Device|spinal cord stimulation experimental|If the patient has been randomized to the branch of the EME experimental group, after a mapping of the search for the pain zone, a 90% subthreshold stimulation is programmed.
15893321|NCT03701997|Device|EXCOR Pediatric|Mechanical circulatory support using ventricular assist device
15893322|NCT03701984|Drug|Lidocaine|The lidocaine group will be administered a 1,000 ml distention medium containing 5 ml lidocaine per 250 ml (DEBOCAINE (LIDOCAINE) 2% 1 VIAL 50 ML, Sigma-Tec pharmaceutical Industry. Co. Egypt) and oral placebo similar to tramadol(given 1 hour before the procedure).
15893323|NCT03701984|Drug|Tramadol|an oral tramadol tablet (Tramal®, Memphis, Giza, Egypt) 1 h before the procedure and with a 1,000 ml distention medium containing 5 ml serum physiologic per 250 ml.
15893324|NCT03701984|Drug|placebo|a 1,000 ml distention medium containing 5 ml serum physiologic per 250 ml and oral placebo(1 h before the procedure).
15893325|NCT03701971|Other|evaluation of the intensity of pruritus|evaluation of the intensity of pruritus with various questionnaires
15893326|NCT03701958|Device|Exalt Model D Single-Use Duodenoscope|Subjects will have a clinically indicated per standard of care ERCP procedure performed with the Exalt single use duodenoscope study device.
15893327|NCT03701945|Other|Pulmonary rehabilitation|Pulmonary rehabilitation will be provided to patients presenting an acute exacerbation. The intervention will be composed of exercise training, education and psychosocial support.
15893328|NCT03701932|Behavioral|TMS and Lumosity®cognitive retraining|The Lumosity® training includes exercises for speed, memory, attention, flexibility, and problem solving. Subjects will complete this battery while receiving TMS treatment.
15893329|NCT03701932|Behavioral|TMS and non cognitive computer games|Subjects will play computer games while receiving TMS treatment.
15893330|NCT03701919|Drug|Botulinum toxin pyloroplasty|Intraoperative laparoscopic injection of Botulinum toxin into the pylorus immediately following sleeve gastrectomy
15893331|NCT03701919|Drug|Normal saline pyloric injection|Intraoperative laparoscopic injection of normal saline into the pylorus immediately following sleeve gastrectomy
15893332|NCT03701906|Dietary Supplement|Lactobacillus PS11603 & Bifidobacterium PS10402|Approximately 8 weeks intervention study: Participants with 0-5 days of age will start a period of 8 weeks of intervention. During this time the participants will intake one daily dose of the product that contains 1*10E9 CFU of L.salivarius PS11603 and 1*10E8 CFU of B.longum PS10402.
15893333|NCT03701906|Dietary Supplement|Placebo|8 weeks intervention study: A 8 weeks intervention period. During the 8 weeks of intervention the participants will intake one daily dose of placebo supplement.
15893334|NCT03701893|Dietary Supplement|Lactobacillus PS11610|7 months and a half intervention study. A 6 months intervention period preceded by a period of sampling and analysis of vaginal, seminal and gland swabs of 6 weeks. During the 6 months of intervention the men participants will intake one capsule that contains 1*10E9 colony forming unit (CFU) of Lactobacillus PS11610 and the women participating will intake two capsules of the same product (each 12 hours). If the couple stay pregnant during the intervention the man will end the product intake and the woman will reduce the dose to one capsule with 1*10E9 CFU of Lactobacillus PS11610 per day during 12 additional weeks.
15893335|NCT03701880|Drug|Ivabradine|Ivabradine is pacemaker current I(f) inhibitor thereby slowing heart rates without exhibiting negative inotropic effect on the myocardium or altering ventricular action potential
15893338|NCT03701841|Drug|PEG-rhG-CSF|All patients need to receive PEG-rhG-CSF 6mg approximately 24h or 48h after chemotherapy administration once per cycle, at least 2 cycles
15893339|NCT03701828|Procedure|Weight loss surgery|All surgery types will be included. However, only participants scheduled for surgery with collaborating surgeons will be included. Surgery is not provided by study team.
15893340|NCT03701815|Behavioral|Wellness in Rehabilitation program|The 12-week Wellness in Rehabilitation program includes weekly in-person meetings including aerobic exercise, nutrition/cooking training, stress management techniques, education, and group support. A health coach will facilitate continuation of healthy behaviors at home.
15893341|NCT03701789|Drug|Baricitinib|Effect of Baricitinib on vBMD measured by HR-pQCT
15893342|NCT03701776|Behavioral|Aerobic Training|Aerobic training on stationary bicycle for 30 minutes a day, 5 days a week for 6 months
15893343|NCT03701776|Behavioral|Balance Training|Standard of care
15893346|NCT03701750|Drug|Low Molecular Weight Heparin (enoxaparin sodium)|enoxaparin sodium 40mg/day subcutaneously after oocyte collection, and routine luteal phase support after embryo transfer until clinical pregnancy confirmed by ultrasound
15893347|NCT03701737|Other|questionnaires|"VAS on the feeling of hunger
~Evaluation of food wanting by the Finlayson test
~PREFQUEST Questionnaire
~24-hour food recall
~Stunkard Questionnaire
~Measurement of daytime sleepiness by Epworth score"
15893348|NCT03701737|Device|wrist actimeter|Actimeter delivery: it is worn on the wrist for 7 days, 24 hours a day.
15893349|NCT03701737|Biological|Blood samples|2 dry tubes of 7 ml of blood collected at each visit for plasma assays (ghrelin, leptin, FGF 21, amino acids including tryptophan, insulin resistance)
15893350|NCT03701724|Device|Systematic maintenance rTMS|Same parameters as the initial course (session of 8,5 minutes, at 1 Hz, on the right dorsolateral prefrontal cortex (DLPFC) targeting with either neuronavigation or the Beam). The frequency is : 2 sessions / week during 1 month, then 1 session / week during 2 months and finally 1 session every 2 weeks during 8 months.
15893351|NCT03701724|Device|rTMS course in case of relapse|Same parameters as the initial course. The frequency is the same as the initial course: one daily session on 5 consecutive working days from Monday to Friday for at least 20 to 30 sessions over 4 to 6 weeks.
15893352|NCT03701724|Device|sham rTMS|The sham stimulation consists of the identical rTMS procedure at the identical location using a commercial figure-eight sham coil. However, it does not produce the identical tactile sensation. A local electrical stimulation will be delivered with two disposable Electromyogram (EMG) electrodes using a transcutaneous electrical nerve stimulation (TENS) Stimulator.
15893353|NCT03701711|Drug|Lenalidomide|"Dose Escalation
~Patients in the dose escalation phase will receive oral treatment with:
~Lenalidomide: 10, 15, or 25 mg on Days 1-21 of every 28-day cycle Dexamethasone: 20mg on Days 1,8,15 and 22
~Starting doses of Lenalidomide will be assigned at the time of registration.
~Dose Expansion
~Once the MTD has been established or determined, 8 additional patients will be treated at the MTD of lenalidomide at the same schedule as above. Dexamethasone will be given at the same dose as in the dose escalation portion of the study."
15893354|NCT03701698|Drug|Ruxolitinib Oral Tablet|Ruxolitinib Oral Tablet （Jakafi）, 5~10mg bid po for at least 28 days.
15893355|NCT03701698|Drug|Methylprednisolone|Methylprednisolone: 2mg/kg/d , iv or iv gtt, for at least 1 week, then taper accordingly.
15893356|NCT03701685|Procedure|nerve flap|sensory reconstruction via a nerve graft included in the flap
15893357|NCT03701672|Other|Opioid Analgesic Treatment|Opioid treatment is determined, prescribed, modified and discontinued at the sole discretion of the treating physician at each research site; regardless of generic name, manufacturer, constituent components, route of administration, and dosing schedule (including titration and run-in periods).
15893358|NCT03701659|Procedure|Surgery combinate with Endocrine therapy|TUPKRP is abbreviation of transurethral plasma kinetic resection of prostate, which is an effective treatment of bladder outlet obstruction for benign prostate hyperplasia. MAB is abbreviation of Maximal androgen blockade, which is a kind of endocrinotherapy for advanced prostate cancer.
15893359|NCT03701659|Drug|Endocrine therapy|MAB is abbreviation of Maximal androgen blockade, which is a kind of endocrine therapy for advanced prostate cancer.
15893360|NCT03701646|Device|Measurement by Clearsight device|Clearsight Device is used to obtain non-invasive measurements to be correlated to standard invasive measurements.
15893361|NCT03701633|Diagnostic Test|Postpartum ultrasound|Measurements of the UtA doppler ultrasound will be carried out twice for each eligible woman on the second day postpartum. The first measurement will take place just prior to a planned breastfeeding. The second measurement will be followed immediately (within 10 min) after the breastfeeding session.
15893362|NCT03701620|Diagnostic Test|HRV monitoring|HRV monitoring derived from electrocardiogram
15893363|NCT03701607|Other|PD-L1 group|PD-L1 expression is evaluated using immunohistochemical assay
15893364|NCT03701594|Other|Yoga-based physical therapy group|All yoga-based sessions will be led by the same therapist to maximize between-session consistency. A trained researcher will also be present to provide additional cueing to subjects when required. The basic elements of the postures are similar to that of traditional physical therapy balance exercises. Cues will be provided throughout to pair appropriate breath cycles with appropriate postures consistent with a standard, able-bodied yoga program. The session will close with a 4-5 minute savasana performed in a supine or seated position pending patient physical abilities, which consists of progressive relaxation, guided meditation, and guided motor imagery.
15893365|NCT03701594|Other|Seated Rest|Subjects will engage in 1 hour of seated rest in a relaxing environment in a group of approximately 2-5 individuals. This session will occur in the same enclosed, quiet space as condition A to minimize outside noise or distraction and to reproduce environment of condition A. The lights will be dimmed, and the same light, instrumental, calming music will be played throughout to contribute to a relaxing ambiance. Subjects will be instructed to rest quietly.
15893417|NCT03701295|Drug|Azacitidine|Given IV or SC
15893418|NCT03701295|Drug|Pinometostat|Given IV
15893419|NCT03701282|Drug|Ibrutinib|Given PO
15893420|NCT03701282|Biological|Obinutuzumab|Given IV
15893366|NCT03701594|Other|Conventional Physical Therapy|"Subjects will engage in 1 hour of a conventional PT session (or treatment as usual) led by a different physical therapist than who is leading the yoga-based session to minimize bias. There will be no restrictions on what can and cannot occur during conventional PT sessions in order to accurately represent and preserve the wide range of treatments that may occur during a physical therapy session in the inpatient setting. Examples of what may occur include, but are not limited to: gait, standing balance, functional mobility, or therapeutic exercise."
15893367|NCT03701581|Drug|4-Aminopyridine|FDA-approved tablets.
15893368|NCT03701581|Other|Placebo|Placebo will be tooled to look similar to the study drug.
15893369|NCT03701568|Drug|dC/dT|Collection of retrospective data from TK2 patients previously treated with dC/dT
15893370|NCT03701555|Other|PvP001 placebo|placebo
15893371|NCT03701555|Drug|PvP001 100 mg|PvP001 100 mg
15893372|NCT03701555|Drug|PvP001 300 mg|PvP001 300 mg
15893373|NCT03701555|Drug|PvP001 900 mg|PvP001 900 mg
15893374|NCT03701555|Drug|Maximum Feasible Dose (MFD) of PvP002|MFD of PvP002
15893375|NCT03701555|Drug|Maximum Tolerated Dose (MTD) of PvP001|Maximum Tolerated Dose (MTD) of PvP001
15893376|NCT03701555|Drug|MTD of PvP001 following 7 days of PPI treatment|Maximum Tolerated Dose (MTD) of PvP001 following 7 days of PPI (Proton Pump Inhibitor) treatment
15893377|NCT03701555|Other|PvP002 placebo|Placebo
15893378|NCT03701555|Drug|PvP001 600 mg|PvP001 600 mg
15893379|NCT03701555|Drug|PvP003 placebo|Placebo tablet orally.
15893380|NCT03701555|Drug|PvP003|PvP003 tablet orally.
15893381|NCT03701555|Drug|PvP003 150 mg|PvP003 150 mg
15893382|NCT03701542|Diagnostic Test|Microperymetry|Microperimetry is a procedure to assess retinal sensitivity while fundus is directly examined; it enables exact correlation between macular pathology and corresponding functional abnormality.
15893383|NCT03701542|Diagnostic Test|M-charts|The M-chart (Inami Co., Tokyo, Japan) is a diagnostic tool developed by Matsumoto to quantify the degree of metamorphopsia in patients with macular diseases.
15893384|NCT03701529|Drug|Sevoflurane|1.5-2.5 vol % sevoflurane is used for maintenance of anesthesia.
15893385|NCT03701529|Drug|Propofol|2-5 mcg/ml of propofol is used for maintenance of anesthesia.
15893386|NCT03701516|Device|etafilcon A with novel molding process|TEST Lens
15893387|NCT03701516|Device|etafilcon A with current molding process|CONTROL Lens
15893388|NCT03701503|Behavioral|Diet with balance composition to know the effect of a meal to gut hormones in obese and non obese women|
15893389|NCT03701490|Drug|Progesterone subcutaneous|25 mg/twice a day.
15893390|NCT03701490|Drug|Progesterone Vaginal Product|200 mg three times a day.
15893391|NCT03701477|Behavioral|Trans-diagnostic cognitive-behavioral therapy|10 therapeutic sessions hold in groups of 5-10 individuals. Details about each session: Session 1: Establishing rapport, psychoeducation; Session 2: Relaxation, hierarchy development; Session 3: Identifying automatic negative thoughts, guided imaginary; Session 4: Cognitive restructuring; Session 5: Problem solving skills training, distraction; Session 6: Exposure-based procedures, cognitive restructuring; Session 7-9: Advanced cognitive restructuring, stress management, assertiveness skills training, preparation for termination phase; Session 10: Relapse prevention, termination
15893392|NCT03701477|Behavioral|General relaxation/stress management therapeutic session|Patients will attend a 3-hour meeting in which basic techniques of relaxation and stress management will be discussed.
15893393|NCT03701464|Procedure|Endoscopic naso-gallbladder drainage|Using ERCP technique insert a naso-gallbladder drainage tube through common bile duct and cystic duct.
15893394|NCT03701464|Procedure|Percutaneous gallbladder drainage|Percutaneous transhepatic technique insert drainage tube into gallbladder
15893395|NCT03701451|Drug|Demethylated drug decitabine|Induced treatment by demethylating drug decitabine 7mg/m2 d1-5 and cisplatin 80mg/m2 d1 for 3 cycles to regionally advanced nasopharyngeal carcinoma followed by concurrent chemoradiotherapy with cisplatin 80mg/m2 d1 for 3 cycles.
15893396|NCT03701438|Biological|Influenza Vaccine|Administered per standard of care using a vaccine licensed and recommended in the site's country
15893397|NCT03701425|Dietary Supplement|Mediterranean diet and exercise plan|"Mediterranean diet:
~Diet: according to the definition, with the following distribution of macro nutrients:
~Protein contribution 0.8-1.2 Carbon Hydrates 45-50% Lipids 30%"
15893398|NCT03701412|Radiation|MRI|MRI brain
15893401|NCT03701386|Procedure|cesarean hysterectomy|Elective cesarean hysterectomy will be planned at 37-38 weeks of gestation. An adequate amount of blood products was prepared to be available for transfusion. Delivery will be performed by the same multidisciplinary team, including two expert obstetricians, an assistant, an expert anesthesiologist, and a pediatrician.
15893402|NCT03701386|Procedure|N&H sandwich technique|In the N&H group, after acceptable control of bleeding from the placental bed, the internal os of the cervix was identified a double uterine compression suture at the lower uterine segment with inflated Foley's catheter balloon tamponade will be performed
15893403|NCT03701373|Drug|S-1 maintenance|S-1 maintenance till disease progression or untolerable toxicities, in oral doses of 40 mg (BSA<1.25 m2), 50 mg (1.25≤BSA<1.50 m2) and 60 mg (BSA≥1.50 m2) b.i.d. on days 1-14 for each 21-day cycle.
15893404|NCT03701373|Other|Observation|Observation without anti-tumor treatment
15893405|NCT03701347|Device|Reeve's model|Reeves, K. O., Young, A. E., & Kaufman, R. H. (1999). A simple, inexpensive device for teaching the loop electrosurgical excision procedure. Obstetrics and Gynecology, 94(3), 474-5.
15893406|NCT03701347|Device|Hefler's model|Hefler, L., Grimm, C., Kueronya, V., Tempfer, C., Reinthaller, A., & Polterauer, S. (2012). A novel training model for the loop electrosurgical excision procedure: An innovative replica helped workshop participants improve their LEEP. American Journal of Obstetrics and Gynecology, 206(6)
15893407|NCT03701347|Device|Ida's model|Reusable, portable and modular 3D printed simulator
15893410|NCT03701321|Drug|Bortezomib|Given SC
15893411|NCT03701321|Biological|Daratumumab|Given IV
15893412|NCT03701321|Drug|Dexamethasone|Given PO
15893413|NCT03701321|Drug|Venetoclax|Given PO
15893423|NCT03701256|Procedure|Bilateral ultrasound guided TAP bloc|In the TAP group: Bilateral ultrasound guided TAP bloc for laparoscopic gynecologic surgery
15893424|NCT03701256|Drug|Neuromuscular blockade agent: Atracurium 01mg/kg per bolus|In the TRAC group: Neuromuscular blockade agent: Atracurium 01mg/kg per bolus for maintaining muscular relaxation and immobilization during laparoscopic gynecologic surgery
15893425|NCT03701243|Procedure|mNT-BBAVF|Briefly, to construct an mNT-BBAVF, an incision is made on the ulnar side of the elbow. The brachial artery and basilic vein are then isolated, and a side-to-side anastomosis is performed without transposition of the basilic vein.
15893426|NCT03701243|Procedure|RCAVF|Briefly, to construct a wrist RCAVF, an incision is made on the radial side of the wrist. The radial artery and cephalic vein are then isolated, and a end-to-side anastomosis is performed.
15893427|NCT03701230|Other|low temperature rota-flush solution|Patients with severe calcified lesions undergoing RA were performed with low temperature rota-flush solution. The investigators used thermal insulation equipment to keep rota-flush solution at 0～5℃. The EKG and blood pressure were monitored during the RA procedure. After RA, the investigators monitored levels of myocardial injury biomarkers for 3 days every 8 hours.
15893428|NCT03701217|Drug|Eltrombopag|Eltrombopag 25mg bid, starts from the day when platelet count decreases lower than 30×10'9/L, and the treatment lasts for at least 5 days, and stops until platelet count goes up to more than 30×10'9/L, after consolidation therapy in AML patents.
15893429|NCT03701204|Behavioral|DynamiCare Rewards|"Participants assigned to the DynamiCare Rewards group will receive the following:
~App on their smartphone
~Substance Testing Devices: BACTrack Mobile Pro - submits BAC results directly to smartphone via Bluetooth and Saliva Test Kits.
~Next Step debit card to receive financial incentives
~Participant will be prompted via the app to conduct breathalyzer/saliva tests, using the devices camera to take selfie photo/videos to prevent cheating.
~Negative tests result in participant receiving electronic virtual coins, which can be transferred from reserve account (reserve account inaccessible to participant) to the spendable Next Step debit card.
~The amount of coins and funds are available on a progressive variable reward schedule."
15893430|NCT03701191|Procedure|Inverted periosteal pedicle flap|The periosteum will be used as an autogenous graft after raising a partial thickness flap in group A
15893431|NCT03701178|Other|BioHPP PEEK|milled BioHPP PEEK in a new material can be used as a dental restoration
15893432|NCT03701165|Device|DryMouth Shield|The DryMouth Shield provides an elastomeric, one-piece design with breath-actuated, one-way valves configured to create an air-tight seal between the teeth and lips, which effectively reduces oral venting and air leakage while also allowing air flow into the mouth by generating a high-volume, low resistance airflow during inhalation while sealing when the user exhales.
15893433|NCT03701152|Device|Negative pressure therapy|Negative pressure therapy at sub atmospheric level
15893434|NCT03701139|Procedure|posterior capsulotomy|After phacoemulsification with intraocular lens implantation, primary posterior capsulotomy will be performed to remove the primary posterior capsule opacification after posterior capsule polishing. A limited anterior vitrectomy will be performed if the anterior hyaloid surface is broken.
15893435|NCT03701139|Procedure|laser capsulotomy|A routine phacoemulsification with intraocular lens implantation is performed. Then the Nd:YAG laser capsulotomy will be performed 1 month postoperative to remove the primary posterior capsule opacification.
15893436|NCT03701126|Procedure|Transversus Abdominis Plane Block|ultrasound (US) guided TAP block will be done to the patients using 0.25% bupivacaine, in a dose of (1 ml / kg).
15893437|NCT03701126|Procedure|Caudal Block|ultrasound (US) guided caudal block will be done to the patients using 0.25% bupivacaine, in a dose of (1 ml / kg).
15893438|NCT03701126|Drug|Bupivacaine 0.25% Injectable Solution|Dose 1ml /kg of patient body weight
15893439|NCT03701126|Device|Ultra-sound guidance|using superficial high frequency probe to guide regional anesthesia
15893440|NCT03701113|Dietary Supplement|Milk-based protein matrix (MBPM)|Ingestion of the Test Product at 10:00 pm, post-absorptive of the evening meal, each day for the 24 week period of intervention
15893441|NCT03701113|Dietary Supplement|Habitual dietary behaviour|Subjects to maintain habitual dietary behaviour for the 24 week intervention
15893442|NCT03701100|Device|tDCS|tDCS
15893443|NCT03701087|Drug|Vitamin D|2800 IU daily till 26 weeks of pregnancy
15893444|NCT03701074|Drug|Ibuprofen and acetaminophen|Intravenous ibuprofen given concomitantly with oral acetaminophen
15893445|NCT03701074|Drug|Ibuprofen and placebo|Intravenous ibuprofen given concomitantly with oral placebo
15893446|NCT03701061|Biological|Seasonal Influenza Vaccine|A single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent) will be administered to the subjects participated in HIPCVAX-010 Study
15893447|NCT03701061|Biological|Seasonal Influenza Vaccine|A single dose of the FDA-approved 2018-2019 seasonal influenza vaccine (Fluarix Quadrivalent) will be administered to the subjects participated in HIPCVAX-010 Study
15893448|NCT03701048|Procedure|Cesarean Section|Pfnannenstiel incision will be done under general or spinal anaesthesia. The abdomen will be opened and fetus and plasenta will be delivered. Then abdomen will be closed.
15893449|NCT03701035|Behavioral|Aerobic Training & UL Motor Training|Aerobic training at 40%-59% Heart Rate Reserve (AT) increasing from personal maximum time (if < 40 mins) to 40 minutes followed by UL motor training with the Armeo®Spring/Senso/Pablo X2®
15893450|NCT03701035|Behavioral|Non-aerobic training & UL Motor Training|40 minutes non-aerobic gait & balance circuit training followed by UL motor training with the Armeo®Spring/Senso/Pablo X2®
15893451|NCT03701022|Drug|SHR1210|SHR-1210 injection, 200 mg/dose, intravenous infusion within 20-60 minutes. Apatinib oral administration, 500mg per day.
15893452|NCT03701009|Procedure|CBD stone removal via lithotripsy|Hold saline irrigation just after X-ray demonstrated no stone residue, a Spyglass explored.
15893453|NCT03701009|Procedure|Saline 50ml|If not clean, intermittent saline irrigation 50ml, and Spyglass explored second time.
15893454|NCT03701009|Procedure|Saline +50ml|If still have some stone fragments, intermittent saline irrigation another 50ml after the second Spyglass detection, Spyglass explored third time to evaluate stone clearance.
15893455|NCT03700983|Dietary Supplement|Nutri-PEITC jelly|an edible, easily to swallow nutritious gel containing a bioactive compound PEITC
15893456|NCT03700970|Drug|Liposomal bupivacaine|20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
15893458|NCT03700957|Dietary Supplement|Docosahexaenoic Acid|100 milligrams of Docosahexaenoic Acid
15893459|NCT03700957|Other|placebo|placebo
15893460|NCT03700944|Other|Yoga training|Complete protocol with yoga training for a period of 8 weeks, 60 minutes, 3 times a week.
15893461|NCT03700931|Behavioral|Eating recall condition|Recall of eating episodes would increase subsequent intake of fruit or vegetable items
15893462|NCT03700931|Behavioral|Non-eating recall condition|Recall of non-eating episodes would not influence subsequent intake of fruit or vegetable items
15893463|NCT03700918|Device|DaVingiTR System|DaVingiTR Tricuspid valve annuloplasty repair device
15893464|NCT03700905|Procedure|Surgical resection of primary tumor|Surgical resection of primary tumor including neck dissection according to standard of care
15893465|NCT03700905|Radiation|Adjuvant radio(-chemo)therapy|Risk-adapted adjuvant radio(-chemo)therapy 56-66 Gy (chemotherapy Cisplatin 100 mg/m2 on days 1, 22, 43, or Cisplatin once weekly (40mg/m2) for high risk patients only)
15893466|NCT03700905|Drug|Neoadjuvant Nivolumab|Neoadjuvant dose with Nivolumab 3mg/kg after randomization within 2 weeks before surgery
15893467|NCT03700905|Drug|Adjuvant Nivolumab|Administration of Nivolumab 3mg/kg i.v. d1 every 2 weeks within 6 weeks after end of radiotherapy until progression or up to 6 months
15893468|NCT03700905|Drug|Adjuvant Nivolumab and Ipilimumab|Administration of Nivolumab 3mg/kg i.v. d1 every 2 weeks and Ipilimumab 1mg/kg i.v. d1 every 6 weeks within 6 weeks after end of radiotherapy until progression or up to 6 months
15893469|NCT03700892|Other|Cinnamaldehyde e-liquid|Participants will inhale an e-liquid that contains cinnamaldehyde from Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).
15893470|NCT03700892|Other|PG/VG e-liquid|Participants will inhale an e-liquid that contains PG/VG from the Vapor Shark DNA 250™ e-cigarette device allowing manual control and vapor setting recordings (voltage, wattage, puff volume, and frequency).
15893471|NCT03700879|Radiation|MRI,MRA,Carotid ,vertebrobasilar and Transcranial Doppler|Patients presented with clinical picture and radiography suggestive of acute ischemic stroke will be subjected to a comprehensive evaluation with MRI,MRA,Carotid ,vertebrobasilar and Transcranial Doppler
15893472|NCT03700866|Procedure|Functional splinting time|Functional splinting time is the time needed for the final healing and organization of Peridontal ligament of tooth with extrusive luxation injury to reattach to the alveolus and function normally in the oral cavity
15893473|NCT03700853|Diagnostic Test|Dysphagia Trained Nurse Assessment (DTNAx)|Bedside swallowing assessment carried out by trained nurses
15893474|NCT03700840|Device|Interdental brushes|interdental brush at 4 sites and PCR analysis
15893475|NCT03700827|Other|Resistance Training|High-intensity Resistance Training Group
15893476|NCT03700827|Other|Aerobic Training|Aerobic Interval Training Group
15893477|NCT03700814|Drug|Co-amoxiclav|Patients in this group will receive single dose of intravenous co-amoxiclav (Dose: 25 mg/kg body weight) which was injected 30 minutes prior to the incision during surgery.
15893478|NCT03700801|Drug|Triple combination therapy group|Triple oral hypoglycemic therapy based on metformin, dapagliflozin plus saxagliptin.
15893479|NCT03700801|Drug|Premixed insulin therapy group|Subcutaneous injection therapy with insulin aspart 30 in patients with T2DM
15893480|NCT03700788|Drug|Chlorhexidine|2% Chorhexidine (intracranial; remains in canal until removal at next visit)
15893481|NCT03700788|Drug|Calcium Hydroxide|Calcium Hydroxide (intracranial; remains in canal until removal at next visit)
15893482|NCT03700775|Other|Remote Telemonitoring|Using the telemedicine kit, participants will record a daily health session including 2 BP measurements obtained one minute apart. Participants are encouraged to record a health session every day, with a minimum of 5 days per week. Participants are also encouraged to equally divide health session recordings between the mornings and evenings. Every 2 weeks BP measurements will be assessed. If less than 75% of measurements are at goal <130/80 mmHg, the central Telehealth pharmacist will designate drug-therapy intensification according to an evidence-based treatment algorithm that is physician approved. Regardless of BP control, participants will be contacted by their nurse coordinator every 2 weeks. During all telephone visits nurse coordinators emphasize healthy lifestyle habits. Safety protocols are in place for dangerously high or low BP recordings.
15893483|NCT03700762|Diagnostic Test|ultrasound gray-scale ratio|RADinfo radiograph reading system was used to measure the gray-scales of PTMC, NG, and thyroid tissues at the same gain level, the UGSR values of the PTMC, NG, and thyroid tissue were calculated.
15893484|NCT03700749|Drug|2% chlorhexidine + non-coated suture|"Interventions:
~2% alcoholic chlorhexidine non-coated suture"
15893485|NCT03700749|Drug|2% chlorhexidine + coated suture|"Interventions:
~2% alcoholic chlorhexidine triclosan coated suture"
15893486|NCT03700749|Drug|10%povidone-iodine + non-coated suture|"Interventions:
~10% povidone-iodine non-coated suture non-coated suture"
15893487|NCT03700749|Drug|10%povidone-iodine + coated suture|"Interventions:
~10% povidone-iodine triclosan coated suture"
15893488|NCT03700736|Behavioral|Healthy Moms|The 6-month intervention will include dietary and exercise counseling and tips to help participants meet their healthy lifestyle goals. Participants will receive personalized calorie and physical activity goals to help them achieve a healthy weight loss of 1-2 pounds per week. Participants will be encouraged to increase physical activity to 150 minutes per week of moderate intensity activity. Counselors will encourage and support participants to make a plan for incorporating regular physical activity into their lives in a way (i.e., duration per session, frequency per week) that works for that individual woman. We will encourage participants to track their diet and exercise daily. We will encourage participants to use My Fitness Pal to track their diet and activity.
15893489|NCT03700723|Biological|Resusix|spray-dried solvent/detergent treated plasma (blood product)
15893490|NCT03700723|Biological|FP24 (Frozen Plasma)|plasma frozen within 24 hours of phlebotomy
15893491|NCT03700710|Behavioral|Self-Guided Approach|"For a 12-week period, patients will be asked to access the web platform (Evolve, formerly BMIQ), review educational materials, and enter dietary information.
~From January 2019 to February 2021, participants used an earlier version of the platform, which was used in tandem with LoseIt (www.loseit.com), a meal-logging app that integrated with the platform.
~In February 2021, a platform update occurred (Evolve) where the core tenets of the program remained the same and included the dietary data entry directly on the platform."
15909891|NCT03573934|Other|GLP-2+GIP|GLP-2+GIP
15893492|NCT03700710|Behavioral|Dietitian-led Approach|"For a 12-week period, patients will be asked to access the web platform (Evolve, formerly BMIQ), review educational materials, and enter dietary information.
~From January 2019 to February 2021, participants used an earlier version of the platform, which was used in tandem with LoseIt (www.loseit.com), a meal-logging app that integrated with the platform.
~In February 2021, a platform update occurred (Evolve) where the core tenets of the program remained the same and included the dietary data entry directly on the platform.
~Dietitians will access the web platform and provided personalized motivational interview phone calls on a weekly basis."
15893493|NCT03700697|Behavioral|Family Stress Module Intervention|as above
15893494|NCT03700684|Behavioral|Lee Silverman Voice Treatment|Persons with Parkinson's disease receive sixteen hours of voice treatment over a four week period. Participants will practice the vocal exercises at home for an additional four weeks.
15893495|NCT03700684|Device|SpeechVive|Persons with Parkinson's disease wear the SpeechVive device several hours a day over an eight week period during opportunities for communication.
15893496|NCT03700684|Behavioral|Control|Persons assigned to the non-treatment control group will not participate in voice treatment.
15893497|NCT03700671|Other|High intensity interval training|Participants performed HIIT twice a week for eight weeks. Findings were compared to moderate intensity continuous training which followed the same exercise frequency and duration
15893498|NCT03700671|Other|Circuit training|The CT group completed a practical seven-station mixed modality exercise circuit (cycle ergometer, rower, treadmill, sit to stand, knee to elbow and leg kickback with bicep curl) at an intensity of 60-80% HRmax twice per week for eight weeks. Participants initially performed 20 minutes of CT with duration gradually increased to the desired 40 minutes as tolerated
15893499|NCT03700658|Drug|TV-46046 - 1|120 mg/0.3 mL
15893500|NCT03700658|Drug|TV-46046 - 2|60 mg/0.3 mL of 1:1 saline-diluted TV-46046
15893501|NCT03700658|Drug|medroxyprogesterone acetate injectable suspension|104 mg/0.65 mL (injectable suspension)
15893502|NCT03700658|Drug|TV-46046 Placebo|0.3 mL
15893503|NCT03700645|Drug|Allopurinol|Allopurinol
15893504|NCT03700632|Other|patch therapy|The eyes are alternatively patched for 2 hours a day in cases without a dominant eye while in cases with dominancy, the dominant eye is patched five days a week and the non-dominant eye is patched two days a week
15893505|NCT03700619|Other|BRIEF parental survey|estimate incidence of executive functions disorders in preterm children in 11 to 12 year old, born less than 34 weeks of gestation, with the BRIEF parental questionnaire. Effects are potentially important because this study could objectify an increase of risk of executive functions disorders f in preterm children in 11 to 12 year old, and identify associated risk factors. This work could eventually alert pediatrician to be careful at the executive functions and to propose adapted supportive cares.
15893506|NCT03700606|Procedure|High flow nasal cannula|8 liters per minute of blended oxygen through Fisher Paykel Optiflow Jr 2 nasal prongs.
15893507|NCT03700606|Procedure|Nasal CPAP|Nasal continuous positive airway pressure of 5-7 cm/H20 delivered using Ventilator or bubble cpap device through short nasal prongs or a nasal face mask.
15893508|NCT03700593|Device|Single Port Robotic Colorectal Surgery|Single Port Robotic Colorectal Surgery
15893509|NCT03700580|Drug|Hydrogel treatment|Hydrogel dressing containing water, carboxymethyl cellulose and sodium alginate in non-specified proportions, purchased in bulk amounts was sterile dispensed in smaller amounts (200 g) for frequent use.
15893510|NCT03700580|Drug|P1G10|P1G10 containing dressing composed by 8% Polawax, 6% liquid vaseline, 0.06% butylated hydroxytoluene, 0.15% Nipagin, 5% propyleneglycol, 0.1% Nipazol, 0.1% ethylenediaminetetraacetate disodium salt, 0.03% methyl-aminopropanol-95, 0.3% Imidazolidinyl urea, 2% Cyclomethicone, 78.2% distilled water. A single batch of the formulation was made and used throughout the intervention. A sample of this preparation was used to assess the extended stability of the formulation. The formulation was dispensed into 100 g dispensers for weekly use.
15893511|NCT03700567|Other|low temperature contrast|UAP patients undergoing PCI were performed with low temperature contrast. The investigators used thermal insulation equipment to keep contrast at 5℃. The EKG and blood pressure were monitored during the PCI procedure. After PCI, the investigators monitored levels of myocardial injury biomarkers for 3 days every 8 hours.
15893512|NCT03700554|Device|Pleuralvent™|Pneumothorax treatment with Pleuralvent™ device (Heimlich valve device)
15893513|NCT03700554|Procedure|Chest tube|Chest tube insertion
15893514|NCT03700541|Drug|Morphine|Morphine intravenous
15893515|NCT03700541|Drug|Piritramid|Piritramid intravenous
15893516|NCT03700528|Behavioral|Acceptance and Commitment Therapy (ACT)|The process will involve, two, brief, one-to-one contact sessions, one at the beginning and one at the end of the intervention, in a way that is convenient for participants, including Skype, phone, or face to face in person. Following the first one-to-one session there will be eight short online sessions, about 20-30 minutes each. Participants will also be asked to complete some tasks between the sessions, in particular to record their progress briefly and any changes at their medication (i.e. type of drug, dose) in a diary weekly so that they can keep track of your developing skills.
15893517|NCT03700515|Drug|Erythropoietin|Subjects receive weekly infusions of EPO
15893518|NCT03700515|Drug|Placebo|Subjects receive weekly infusions of saline
15893519|NCT03700502|Diagnostic Test|resting-state functional Magnetic Resonance Imaging|The investigators used fraction Amplitude of Low Frequency Fluctuation (fALFF) and Regional Homogeneity (ReHo) of resting-state functional Magnetic Resonance Imaging (rs-fMRI) to explore the brain activity in patients with PDN in order to study the central mechanism. The investigators also evaluated the symptoms, signs and mental conditions of the patients.
15893520|NCT03700489|Other|titanium dioxide denture|patients will receive titanium dioxide denture (made from acrylic resin with titanium dioxide nanoparticles ) for 1 month in the initial phase then in the second phase after one month they will receive( rapid heat cured acrylic resin)denture according to the principle of crossover des
15893521|NCT03700476|Drug|Sintilimab|Sintilimab 200mg will be given every 3 weeks for 12 cycles, started on day 1 of induction chemotherapy.
15893522|NCT03700476|Drug|Gemcitabine|Gemcitabine 1g/m2, d1 & 8 of every cycle, every 3 weeks for 3 cycles before radiation.
15893523|NCT03700476|Drug|Cisplatin|Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation; Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation
15909892|NCT03573934|Other|Placebo|Placebo
15893524|NCT03700476|Radiation|intensity-modulated radiotherapy|Definitive intensity-modulated radiotherapy (IMRT) of 6996cGy will be given in 33 fractions.
15893525|NCT03700463|Other|BRIEF parental survey|Estimate incidence of executive functions disorders in preterm children in 3 to 4 year old, born less than 34 weeks of gestation
15893526|NCT03700450|Drug|Cyclophosphamide|Patients will receive on day 3 and 4 after allogeneic stem cell transplantation 50 mg/kg BW cyclophosphamide
15893527|NCT03700437|Other|Fasting-Mimicking Diet|Chemo-immunotherapy + FMD (fast-mimicking diet)
15893528|NCT03700424|Drug|Trehalose|"Trehalose is a natural disaccharide sugar found extensively among miscellaneous organisms including bacteria, plants, insects, yeast, fungi, and invertebrates. By preventing protein denaturation, it plays various protective roles against stress conditions such as heat, freeze, oxidation, desiccation and dehydration. Owing to this capacity, trehalose is an FDA-approved pharmaceutical excipient that is used as a stabilizer in numerous medicines including parenteral products.
~In this study, all injections will be conducted by a trained nurse in the presence of a specialist physician at a duration of 45-90 minutes."
15893529|NCT03700424|Drug|Normal saline|A solution of 0.90% w/v of sodium chloride (NaCl) in water
15893530|NCT03700411|Drug|Morphine|Morphine intravenous
15893531|NCT03700411|Drug|Piritramid|Piritramid intravenous
15893532|NCT03700411|Drug|Epidural|Perioperative epidural analgesia
15893533|NCT03700398|Device|first OE|optical enhancement(OE)，a kind of electron straining endoscopy
15893534|NCT03700398|Device|first WLI|the routine in the clinical practice
15893535|NCT03700385|Device|IOWA Approach Endocardial Ablation System|Endocardial ablation using the IOWA Approach Endocardial Ablation System
15893536|NCT03700372|Device|IOWA Approach Cardiac Ablation System|Epicardial ablation using the IOWA Approach Cardiac Ablation System
15893537|NCT03700359|Drug|Anlotinib Hydrochloride|Anlotinib: Maintenance therapy 12mg/day P.O., day 1-15 every 21 days (2 weeks on, 1 week off) until progressive disease or treatment discontinuation
15893538|NCT03700359|Drug|Lobaplatin|Lobaplatin:30 mg/m2 IV every 21 days for up to 4 cycles of 21 days
15893539|NCT03700359|Drug|Etoposide|Etoposide: 60 mg/m2 IV every 21 days for up to 4 cycles of 21 days
15893540|NCT03700346|Device|microdialysis|Interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained by using muscle microdialysis
15893541|NCT03700333|Drug|S-1 therapy|accept S-1(50mg, twice a day, morning and night, if<1.5m2; 75mg, twice a day, morning and night,if >1.5m2 )chemotherapy after finishing first-line therapy(>21 days).
15893542|NCT03700333|Drug|Pemetrexed therapy|accept Pemetrexed (500mg/m2,d1)chemotherapy after finishing first-line therapy(>21 days).
15893543|NCT03700320|Drug|Standard of Care (SOC) Migraine Preventive Medication|Standard of care medication selected based on investigator's judgement, recognized as safe and effective for the prevention of migraine.
15893544|NCT03700320|Drug|Atogepant|Atogepant tablets taken orally, once daily for 52 weeks.
15893545|NCT03700307|Procedure|Cryoballoon ablation|Cryoablation is performed using a single cryoballoon.In general, the cryoablation of each pulmonary vein is carried out twice.
15893546|NCT03700294|Drug|ADCT-601|Intravenous (IV)
15893547|NCT03700281|Behavioral|Messaging|The participants will receive influenza promotion emails, text messages, and U.S. mail from Sendero Health Plans.
15893548|NCT03700281|Behavioral|Incentive|Participants will be eligible for a gift card to a local grocery store chain as an incentive for obtaining an influenza vaccine
15893549|NCT03700268|Other|Manual intervention to programme Cochlear Implant electrodes|The Clinician test the 22 electrodes so that the patient is able to hear the language
15893550|NCT03700255|Procedure|PickUpSimTM simulation training program|"The residents will take part in simulation sessions of 30 minutes duration. There will be 4 training sessions with seven simulation scenarios available. During the sessions, the following data will be collected for each scenario success or failure, reason for failure, time needed for completion, and oocyte retrieval rate. All scenarios will be repeated in the same conditions in the second week and data collected again. In the following 15 days, residents will start performing OPU, under direct supervision from senior physicians. For each patient, the resident will puncture one ovary. During the retrieval, the operator will specify the number of follicles punctured for each collected tube. The identity of the operator and the number of follicles punctured (per tube and in total) are noted on a separate sheet entitled the retrieval sheet. After the first month, residents will start performing all the OPUs, including both ovaries, supervised by the senior physicians."
15893551|NCT03700242|Biological|HDCV|Pharmaceutical form:Solution for injection Route of administration: Intramuscular
15893552|NCT03700242|Biological|HDCV|Pharmaceutical form:Solution for injection Route of administration: Intradermal
15893553|NCT03700242|Biological|PVRV|Pharmaceutical form:Solution for injection Route of administration: Intramuscular
15893554|NCT03700242|Biological|PVRV|Pharmaceutical form:Solution for injection Route of administration: Intradermal
15893555|NCT03700229|Drug|Bortezomib|Bortezomib intravenously 1.3mg/m2 d1,4,8,11 for 4 doses
15893556|NCT03700229|Drug|Rituximab|rituximab intravenously 500 mg for one dose
15893557|NCT03700177|Drug|Dexamethasone|modified pectoralis block for breast surgery with ropivacaine combined with dexamethasone 8mg.
15893558|NCT03700177|Drug|Placebo|modified pectoralis block for breast surgery with ropivacaine combined with placebo (NaCl 0,9%).
15893559|NCT03700177|Drug|Ropivacaine Injection [Naropin]|30ml (=60mg) for modified pectoralis block (thoracic regional fascial plane block)
15893560|NCT03700164|Other|Temperature|Water-perfused suit.
15893561|NCT03700151|Behavioral|Treatment for Children with Severe Speech Sound Disorders|The intervention has two tasks, including syllable repetition tasks which requires participants to repeat nonsense syllables, and training of vocabulary or phrase with the application of Principle of Motor Learning.
15893562|NCT03700138|Drug|Privigen® 100mg/ml at the dose of 2g/kg of body weight|The treatment (IV Ig, 100mg/ml at the dose of 2g/kg of body weight) will be administered by perfusion every 4 weeks, with a total of 3 perfusions administered (W0, W4, W8).
15893563|NCT03700138|Drug|NaCl 0,9%|The treatment (NaCl 0,9% 20 ml/kg) will be administered by perfusion every 4 weeks, with a total of 3 perfusions administered (W0, W4, W8).
15893564|NCT03700125|Procedure|ECMO resuscitation|Extracorporeal Cardio-Pulmonary Resuscitation (ECPR) using ECMO within 30 minutes of cardiac arrest
15893565|NCT03700112|Other|JUUL Virginia Tobacco flavored 5.0% ENDS|Virginia Tobacco Flavored 5.0% ENDS product is administered using a controlled method and adlibitum
15893566|NCT03700112|Other|PMI iQOS Heat sticks|PMI IQOS Heat sticks is administered using a controlled method and ad-libitum
15893567|NCT03700112|Other|Reynolds VUSE Solo ENDS - Original|Reynolds VUSE solo ENDS - Original is administered using a controlled method and ad-libitum
15893568|NCT03700112|Other|Imperial MyBlu ENDS - Original|Imperial MyBlu ENDS- original is administered using a controlled method and ad-libitum
15893569|NCT03700112|Other|Altria MarkTen ENDS - Bold Classic|Altria MarkTen ENDS - Bold Classic is administered using a controlled method and ad-libitum
15893570|NCT03700112|Other|MLV PHIX ENDS - Original Tobacco|MLV PHIX ENDS - Original Tobacco is administered using a controlled method and ad-libitum
15893571|NCT03700112|Other|NJOY Daily EXTRA ENDS - Rich Tobacco|NJOY Daily EXTRA ENDS - Rich Tobacco is administered using a controlled method and ad-libitum
15893572|NCT03700112|Other|Altria Marlboro combustible cigarette - Red|Altria Marlboro combustible cigarette - Red is administered using a controlled method and ad-libitum
15893573|NCT03700099|Drug|Docetaxel|Docetaxel 75 mg/m2 IV every 3 weeks, for 6-10 cycles.
15893574|NCT03700099|Drug|Enzalutamide|Upon disease progression after treatment with docetaxel, patients will receive Enzalutamide 160 mg P.O. daily until disease progression or limiting toxicity.
15893575|NCT03700086|Device|Disposable negative wound pressure device (PICO)|Application of a disposable negative wound pressure device for surgical site infection prevention.
15893576|NCT03700086|Device|OPsite post-op visible standard sterile dressing|Application of a standard sterile wound dressing.
15893577|NCT03700073|Other|Experimental group (GTVR)|Gait training with a robotic system (CL1Walker) combined with immersion in a Virtual Reality program
15893578|NCT03700073|Other|Control group (GT)|Gait training with a robotic system (CL1Walker) alone.
15893579|NCT03700034|Other|mHealth Integrated Model of Antenatal Care|Non-physician front line health workers (FHWs) will screen, detect, and refer PIH and GDM cases. Physicians will be trained to manage PIH and GDM. In the intervention clusters, pregnant women will receive enhanced antenatal care via a Frontline Health Worker (FHW), supported by an electronic decision support system (EDSS). This will integrate the screening, detection, and referral/management of GDM and PIH with existing antenatal care services, prompt FHWs to provide routine care, and help them record and report data upwards. Non-physician FHWs will not prescribe treatments, but they will carry out all other duties including diagnosis, referral to an appropriate physician to prescribe drugs, provide lifestyle advice, follow-up, and subsequently support adherence to management plans.
15893580|NCT03700008|Diagnostic Test|Speech analysis tool|Using the speech analysis tool with recording 120 seconds of free speech and analysis of 200 content-free parameters of the speech including factor analytic process to compress the data to 5-10 core parameters.
15893581|NCT03700008|Diagnostic Test|Conventional psychological measurements|Using well known and validated psychological measurements to identify the mental state of the participants.
15893582|NCT03699995|Other|Confocal Microscopy|Undergo confocal microscopy
15893583|NCT03699995|Other|Dermoscopy|Undergo digital dermoscopy
15893584|NCT03699995|Procedure|Imaging Technique|Undergo MoleMapper/Sklip app/native smartphone camera app imaging with smartphone
15893585|NCT03699995|Drug|Lidocaine|Given SC
15893586|NCT03699995|Procedure|Punch Biopsy|Undergo punch biopsy
15893587|NCT03699995|Procedure|Shave Biopsy|Undergo shave biopsy
15893588|NCT03699982|Other|Daily calorie target based on resting energy expenditure|"Resting Energy Expenditure will be determined using the Harris-Benedict formula and indirect calorimetry testing. Additionally, a 48 Hour Dietary Recall will be completed to estimate approximate caloric intake at baseline.
~Participants will be instructed to increase their daily calorie intake based on the highest REE/caloric intake, whether by indirect calorimetry, the Harris-Benedict formula, or patient's estimated current caloric intake."
15893589|NCT03699969|Radiation|Hypofractionated dose escalated VMAT|measure the local control, progression free survival and overall survival
15893590|NCT03699956|Combination Product|RRx-001 + eLOOP Device|RRx-001 is a small molecule anticancer drug which is mixed with patient's own blood using the eLOOP device
15893591|NCT03699956|Drug|Cisplatin/carboplatin plus etoposide|Standard of care platinum doublet chemotherapy
15893592|NCT03699943|Procedure|CaverStem|
15893593|NCT03699930|Device|tDCS|Anodal or sham tDCS will be applied to the scalp.
15893594|NCT03699930|Behavioral|Speech and language therapy|A trained speech pathologist will administer the speech and language therapy.
15893595|NCT03699904|Drug|Valaciclovir|Participants will self-administer Valaciclovir 1 gram three times daily for 8 weeks.
15893596|NCT03699904|Drug|Placebo capsules (containing Avicel blend)|Participants will self-administer two matching placebo capsules (containing Avicel blend) three times daily for 8 weeks.
15893597|NCT03699891|Device|Fortilink IBF System with TETRAfuse Technology|Cervical and lumbar fusion
15893598|NCT03699865|Other|Nicotine content|Study-supplied cigarettes will contain either intermediate or very low nicotine content
15893599|NCT03699852|Radiation|Membracel and LED photobiomodulation|Participants were positioned so that the skin graft donor area was accessible. A light-emitting diode (LED) plate was covered with sterile transparent and waterproof film to prevent contamination when in contact with the donor area. The application was in contact, with full coverage of the surgical wound and was irradiated with radiant exposure of 1.53J / cm2 and irradiance of 2.55 mW / cm2 for 10 minutes. It is worth mentioning that the LED plate was applied in direct contact with the skin graft donor area in the immediate postoperative period and on the primary cover used (Membracel®) on the 1st, 3rd, 5th and 7th postoperative days. Coverage remained until spontaneous departure. The researcher and the participants used specific goggles for this procedure.
15893600|NCT03699852|Other|Membracel|This group did not receive LED application, remaining with the skin donor area covered by Membracel® and were evaluated under the same conditions.
15893601|NCT03699839|Biological|High-dose influenza vaccine|The experimental intervention consists in an intramuscular injection of a MF59-adjuvanted trivalent inactivated influenza vaccine containing 15 µg of antigen per strain (Fluad®) or an intramuscular injection of trivalent inactivated influenza vaccine containing 60 µg of antigen per strain (Fluzone-HD®) and will be performed at day 0.
15893940|NCT03697200|Other|APA|Light touch using vaccaria seeds on specific points of the ear
15893602|NCT03699839|Biological|MF59-adjuvanted influenza vaccine|The experimental intervention consists in an intramuscular injection of a MF59-adjuvanted trivalent inactivated influenza vaccine containing 15 µg of antigen per strain (Fluad®) or an intramuscular injection of trivalent inactivated influenza vaccine containing 60 µg of antigen per strain (Fluzone-HD®) and will be performed at day 0.
15893603|NCT03699839|Biological|Standard intramuscular influenza vaccine|The control intervention consists in an intramuscular injection of one dose of VaxigripTetra®, the standard non-adjuvanted intramuscular influenza vaccine (as routinely done).
15893604|NCT03699826|Device|TMS for tinnitus|Targeted stimulation to decrease tinnitus symptom severity.
15893605|NCT03699813|Other|Comparison of two approaches to bleeding management|
15893606|NCT03699800|Other|Graphomotor intervention program|The graphomotor intervention program aims to promote the development and reinforcement, different skills involved in the learning process of handwriting and has a preventive character. It follows a bodily, playful, multisensory, exploratory (sensory integration) and neuromotor task training approach and focuses on the following intervention domains: segmental awareness, passive relaxation, trunk-limb dissociation, interdigital coordination, attention, planning, spatial organization/orientation and perception.
15893607|NCT03699787|Other|Graphomotor intervention program|The graphomotor intervention program aims to promote the development and reinforcement, different skills involved in the learning process of handwriting and has a preventive character. It follows a bodily, playful, multisensory, exploratory (sensory integration) and neuromotor task training approach and focuses on the following intervention domains: segmental awareness, passive relaxation, trunk-limb dissociation, interdigital coordination, attention, planning, spatial organization/orientation and perception.
15893608|NCT03699774|Drug|DS-8500a|DS-8500a is provided as three 25-mg tablets for oral administration
15893609|NCT03699774|Drug|Rosuvastatin|Rosuvastatin is provided as a 10-mg tablet for oral administration
15893610|NCT03699761|Procedure|Closure of the pelvic peritoneum|Closure of the pelvic peritoneum after anastomosis for middle-low rectal caner.
15893611|NCT03699761|Procedure|Nonclosure of the pelvic peritoneum|Nonclosure of the pelvic peritoneum after anastomosis for middle-low rectal caner.
15893612|NCT03699748|Behavioral|Lay Health Worker Intervention|Patients randomized into the intervention will be assigned a lay health worker who will contact the patient to begin the intervention. The intervention includes: education on early advance care planning, documenting goals of care, assessing symptoms, and coordinating community services (such as home health, home visits, and home hospice). The intervention is provided along with usual care as provided by Unite Here Health and local oncologists.
15893613|NCT03699748|Other|Usual Care|Usual care as provided by Unite Here Health and local oncologists
15893614|NCT03699735|Device|Bolero B90-SP|Behind the ear Hearing device fitted with an individual ear mold to compensate a Hearing loss
15893615|NCT03699722|Behavioral|Education + Activities|Format:Video; discussion; information handouts; facilitated referral
15893616|NCT03699722|Behavioral|Information|Format: Information handouts
15893617|NCT03699709|Behavioral|Budgeting, purchasing and cooking educational intervention|Receive culturally-tailored healthy food budgeting, purchasing, and cooking skills curriculum
15893618|NCT03699696|Drug|Propofol|Induction of anesthesia prior to surgery with propofol
15893619|NCT03699683|Other|Combined aerobic and resistance training program|
15893620|NCT03699657|Device|DSM|Monopolar RFA using dual switching mode (DSM)
15893621|NCT03699657|Device|SSM|Monopolar RFA using single switching mode (SSM)
15893622|NCT03699657|Device|Separable clustered electrodes|A separable clustered electrode is similar to a clustered electrode, although it differs from a conventional clustered electrode in that each individual electrode is separable.
15893623|NCT03699644|Device|Spectral-Domain Optical Coherence Tomography (SD-OCT)|Each participant in this study will undergo Optical coherence tomography (OCT), a non-invasive imaging test of the eye, one time. OCT uses light waves to take cross-section pictures of the retina, which are generated using scattered light waves.
15893624|NCT03699644|Device|Magnetic Resonance Imaging (MRI)|Each participant in this study will undergo a single Magnetic resonance imaging (MRI) scan, a scanning technique for creating detailed images of the human body. The scan uses a magnetic field and radio waves to generate images of the brain.
15893625|NCT03699644|Device|Positron Emission Tomography (PET)|Each participant in this study will undergo a single Positron emission tomography (PET) scan of the brain. PET is a nuclear medicine functional imaging technique that is used to observe metabolic processes in the brain as an aid to the diagnosis of disease using the combination of a radioactive tracer, camera, and a computer.
15893626|NCT03699644|Diagnostic Test|Comprehensive Ophthalmic Examination|Each participant in this study will receive one comprehensive eye examination which will be performed by a licensed ophthalmologist at the University of Michigan. This examination will include the assessment of the participant's visual acuity, a slit lamp examination which will look at the anterior and posterior tissues of the eye including the retina using various lights and lenses, and intraocular pressures.
15893627|NCT03699644|Device|Fundus Photography|Each participant in this study will undergo fundus photography of each eye. Fundus photography involves the use of a retinal camera coupled with a low power microscope to capture photographs of the retina.
15893628|NCT03699631|Drug|Tacrolimus|Tacrolimus will be given intravenously at a dose of 0.03 mg/kg/day starting Day -3. Subsequent dosing will be based on blood levels.
15893629|NCT03699631|Drug|Methotrexate|Methotrexate will be administered at the doses of 15 mg/m2 IV bolus on Day +1, and 10 mg/m2 IV bolus on Days +3, +6 and +11 after hematopoietic cell infusion.
15893630|NCT03699631|Drug|Tocilizumab|Tocilizumab will be administered intravenously (IV) at a dose of 8 mg/kg (maximum dose of 800 mg) once on the Day -1 approximately 24 hours prior to the estimated time of the hematopoietic cell infusion, and subsequently, on Day +100 (+/- 14 days, i.e., Days +86 to +114) post-alloHCT. The infusion will be administered over 60 minutes through a dedicated IV line and must not be administered by IV bolus.
15893631|NCT03699618|Drug|Anti-VEGF|Standard of care treatment with anti-VEGF only
15893632|NCT03699618|Other|Hemorrhage displacement + Anti-VEGF|Standard of care treatment with hemorrhage displacement (at investigators' discretion) followed by anti-VEGF injections
15893692|NCT03699241|Biological|BG505 SOSIP.664 gp140, adjuvanted|Dosage of 300ug, Intramuscular administration
15893693|NCT03699241|Biological|Placebo|Tris-NaCl Diluent
15893633|NCT03699605|Other|VESMP|. The application contains following seven domains: spontaneous speech, comprehension, naming, reading, writing, imitation and automated speech. The programme was developed in Urdu language which contains different daily functional words, phrases and sentences. Treatment stimuli consisted of images of objects along with auditory sounds of person and actions cues. The voice output can operate by pressing the selected picture with index finger. Participants received 1-16 weeks of therapy using software of two domains with different difficulty levels. Specifically the programme included seven domains within the software comprising of eight 30-45 minutes sessions (4 days per week for total 16weeks). The measurement will be taken at 0 week (baseline) after 16 weeks.
15893634|NCT03699605|Other|Traditional Therapy|, All subjects participated in an traditional therapy group in routine and received MIT for 4 months of periods with three sessions per week to improve language skills.
15893635|NCT03699592|Behavioral|Reach Home and Read Toolkit|The toolkit currently includes one age-appropriate book along with a set of educational pamphlets explaining the importance home literacy. These educational materials focus on appropriate literacy milestones and descriptions of how parents can engage with their children around books. In addition, we will create an information sheet outlining zipcode-specific community literacy resources, including location and information on how to access the library, where to obtain low-cost books, and a schedule of literacy promotion activities in their community (e.g. community reading sessions). All materials will also be translated into Spanish by a certified interpreter, and will be reviewed to ensure that they are written at a fifth grade reading level. Additionally, EDCI families receiving this intervention will also receive an additional new book at each home visit conducted during the study period.
15893636|NCT03699566|Other|Assessment of Respiratory Muscle Strength|The maximal voluntary inspiratory (PImax) and expiratory (PEmax) pressure measurements of the subjects were performed using Cosmed Pony FX model (Italy 2001) while the subjects were in the sitting position with a nose clip.
15893637|NCT03699566|Other|Spirometer|Spirometric measurements were conducted with Cosmed, Pony FX (descopt spirometer- Italy 2001) spirometer using a nose clips while the subjects were in 90 degree relaxed sitting position.
15893638|NCT03699566|Other|Trunk Muscles Endurance Tests|Trunk muscle endurance of the subjects was measured using four different tests (Side Bridge Test- SBT, Prone Bridge Test- PBT, Flexor Endurance Test- FET, Sorenson Test- ST).
15893639|NCT03699553|Behavioral|LARKSPUR; Online Positive Emotions Skills for Individuals with Chronic Musculoskeletal Pain|8 positive emotion skills taught over 5-6 weeks to help individuals cope with chronic pain and stress.
15893640|NCT03699553|Behavioral|Emotion Reporting Control Group|Attention matched control condition, participants will report their daily emotions over 5-6 weeks online.
15893641|NCT03699540|Drug|Marijuana|Experimental, non-therapeutic administration of active and inactive marijuana dose(s)
15893642|NCT03699540|Drug|Alcohol|Experimental, non-therapeutic administration of active and inactive alcohol dose(s)
15893643|NCT03699527|Behavioral|Multiple questionnaires administered|This is an observational trial
15893644|NCT03699514|Device|Brain Network Activation (BNA™) technology|"The BNA™ technology was developed and is utilized by ElMindA Ltd. The BNA Analysis System is cleared for use by qualified medical professionals for the post hoc statistical analysis of the human electroencephalogram (EEG), utilizing evoked response potentials (ERP'). This device is indicated for use in individuals 14 to 24 years of age. The BNA Analysis System is to be used with the auditory oddball task only."
15893645|NCT03699501|Other|Questionnaires|"A validated oral health-related quality of life self-assessment questionnaire: the GOHAI
~A validated oral health-related quality of life self-assessment questionnaire to be validated: SOHP
~A validated depression scale: the Beck scale
~A self-assessment questionnaire for oral health coping to be validated: the SCOOHP
~A validated self-assessment questionnaire for coping: The Brief cope)"
15893646|NCT03699501|Procedure|Oral examination|"An evaluation of dental health using the CAO index
~An evaluation of oral hygiene with the IHO-S index"
15893647|NCT03699501|Other|questionnaires (test-retest)|SCOOHP and SOHP questionnaires
15893648|NCT03699488|Behavioral|psychotherapy via asynchronous message|Behavioral psychotherapy delivered by asynchronous message using the Talkspace application
15893649|NCT03699475|Biological|rivogenlecleucel|Biological: T cells transduced with caspase 9 safety switch
15893650|NCT03699475|Drug|rimiducid|administered to inactivate rivogenlecleucel in the event of GVHD
15893651|NCT03699475|Drug|Cyclophosphamide|GVHD prophylaxis
15893652|NCT03699475|Procedure|haplo-HSCT|treatment for disease
15893653|NCT03699462|Drug|Plasma solution-A injection|The group receiving balanced crystalloid solution (Plasma solution-A injection, CJ Pharma, South Korea) during surgery
15893654|NCT03699462|Drug|5% Albumin|The group receiving 5% albumin (Albumin 5% inj, Green cross, South Korea) during surgery
15893655|NCT03699449|Drug|olaparib+cediranib combination therapy|Cediranib (30mg p.o. qd) + Olaparib (200mg p.o. bid) until disease progression
15893656|NCT03699449|Drug|durvalumab + olaparib combination therapy|Durvalumab (1500mg i.v. every 4 weeks starting on week 5 day1 for up to 12 months) + Olaparib (300mg p.o. bid) until disease progression
15893657|NCT03699449|Drug|durvalumab + chemotherapy treatment|"Durvalumab (1500mg i.v. every 4 weeks for up to 24 months) + non-platinum-based standard of care chemotherapy (weekly paclitaxel, topotecan, or Pegylated liposomal doxorubicin(PLD) up to 6 cycles)
~Chemotherapy regimen:
~Weekly Paclitaxel 80mg/m2 (day 1,8,15,22 every 4 weeks), PLD (40mg/m2 on D1 every 4 weeks), topotecan (4mg/m2 on D1,8,15 every 4 weeks)"
15893658|NCT03699449|Drug|durvalumab + tremelimumab + chemotherapy treatment|"Durvalumab (1500mg i.v. every 4 weeks for up to 24 months) + Tremelimumab (75mg i.v. every 4 weeks for up to 4 doses) + non-platinum-based standard of care chemotherapy (weekly paclitaxel, topotecan, or Pegylated liposomal doxorubicin (PLD) up to 4 cycles)
~Chemotherapy regimen:
~Weekly Paclitaxel 80mg/m2 (day 1,8,15,22 every 4 weeks), PLD (40mg/m2 on D1 every 4 weeks), topotecan (4mg/m2 on D1,8,15 every 4 weeks)"
15893659|NCT03699449|Drug|durvalumab + tremelimumab + paclitaxel treatment|"Durvalumab (1500mg i.v. every 4 weeks for up to 24 months) + Tremelimumab (300mg i.v. once) + non-platinum-based standard of care chemotherapy (weekly paclitaxel up to 4 cycles)
~Chemotherapy regimen:
~Weekly Paclitaxel 60mg/m2 (day 1,8,15 every 4 weeks)"
15893742|NCT03698734|Drug|Evening primrose oil(EPO)|primiparous women with missed abortion between(13 to 24 weeks) will receive 1 capsule of EPO( 1000mg) in addition to misopristol
15894517|NCT03692520|Biological|SCT200|Recombinant Anti-EGFR Monoclonal Antibody （SCT200）
15893660|NCT03699449|Drug|durvalumab +chemotherapy treatment|"Durvalumab (1500mg i.v. every 4 weeks for up to 24 months) + non-platinum-based standard of care chemotherapy (paclitaxel, topotecan, or Pegylated liposomal doxorubicin(PLD) up to 4 cycles)
~Chemotherapy regimen:
~Weekly Paclitaxel 80mg/m2 (day 1,8,15,22 every 4 weeks), PLD (40mg/m2 on D1 every 4 weeks), topotecan (4mg/m2 on D1,8,15 every 4 weeks)"
15893661|NCT03699436|Other|Electrotherapy with Galvanic Current|The experimental group will receive an electrotherapy treatment with galvanic current in their hands.This protocol will be administered at weekly sessions of 30 minutes with a period of 3 times / week with a total of 20 sessions, distributed over a 7-week period. They will be evaluated at baseline, after the end of the last treatment session and after two months of follow-up.
15893662|NCT03699436|Other|Control without Electric Stimulation Therapy|The control group continue with their usual conservative and pharmacological treatment and will not receive electrotherapy treatment. They will be evaluated too at baseline, after the end of the last treatment session and after two months of follow-up.
15893663|NCT03699423|Drug|0.01% atropine eye drops|0.01% atropine sulphate
15893664|NCT03699423|Drug|0.02% atropine eye drops|0.02% atropine sulphate
15893665|NCT03699423|Drug|0.03% atropine eye drops|0.03% atropine sulphate
15893666|NCT03699410|Radiation|Neoadjuvant radiotherapy|Radiotherapy with total dose of at least 50 Gy on the tumor (cT) and the involved nodes (cN+) and with standard fractionation (1.8 Gy/fraction), 5 days/week.
15893667|NCT03699410|Drug|Neoadjuvant chemotherapy|Oral Capecitabine, at the standard dose of 825 mg/m2 twice daily, concomitant to radiotherapy.
15893668|NCT03699410|Procedure|Radical surgery|The time point of surgery is usually dependent on surgeon's and institutional habits and lies within 6 to 12 weeks after the end of nCRT. Surgeons participating in this study will be asked to operate patients on the 10th week after the end of nCRT.
15893669|NCT03699397|Diagnostic Test|Dry electrode EEG|A single dry electrode electroencephalography (EEG) will be performed in each patient that is included in this study. To do this, the investigators will use the WaveguardTM dry electrode EEG cap and compatible eegoTM amplifier, developed by ANT Neuro B.V. Netherlands and both CE marked as medical devices in the European Union (see appendices 1 and 2). Both products will be used within the intended use as described in the user manuals. The dry electrode cap is put on the patients head and records the EEG signal for several minutes; the amplifier is used to amplify the EEG signal and reduce artefacts.
15893670|NCT03699384|Drug|Azacitidine|AZA 75 mg/m^2 SC or IV D 1-7 28 day cycle x 1
15893671|NCT03699384|Drug|Avelumab|Avelumab 10mg/kg IV D1, D15, 28d cycle Until progression or MRD If MRD-, tx x 1 yr or go to allo SCT
15893672|NCT03699371|Procedure|Early Supplemental Parenteral Nutrition|Intervention group: would receive EN reaching up to 20 % of daily nutritional requirements and early (on first day of stay in ICU) provision (of up to 80%) of protein (2 g/kg/ day or in case of CRRT 2,5 g/kg/ day) and caloric (15-20 kcal/kg/day) needs in SPN that would be continued until 7th day of stay in ICU. Central venous catheter placement would not be assessed as a part of intervention due to the fact that it is a part of routine medical activities performed during admission to ICU.
15893673|NCT03699345|Device|Transcatheter Aortic Valve Replacement (TAVR)|TAVR with the Edwards CENTERA THV System and accessories
15893674|NCT03699332|Drug|Indium-111-DOTA-Labetuzumab-IRDye800CW injection|Tracer injection
15893675|NCT03699332|Radiation|SPECT/CT scan|Abdominal and thoracic SPECT/CT scan.
15893676|NCT03699332|Procedure|CRS extended with dual-modality imaging|cytoreductive surgery will be performed extended with the use of dual-modality imaging.
15893677|NCT03699319|Drug|CPI 613|"Standard Dose Cohort: CPI-613, 500 mg/m2, IV infusion at a rate of 4 mL/min via a central venous port on days 1 and 3 of each cycle, every 2 weeks.
~Dose Escalation Cohort: CPI-613, 750-1000 mg/m2 IV infusion at a rate of 3 mL/min via a central venous port on days 1 and 3 of each cycle, every 2 weeks.
~Intended treatment protocol is 12 cycles (2 weeks each) or 6 months"
15893678|NCT03699319|Drug|Oxaliplatin|"Administered at 65 mg/m2 given as a 2-hr IV
~Part of SOC mFOLFRINOX treatment combination of Oxaliplatin, Irniotecan, 5-flurouracil, and vitamin derivative (Folinic acid)"
15893679|NCT03699319|Drug|Irinotecan|"Administered at 140 mg/m2 given as a 90-min IV infusion) via a Y-connector
~Part of SOC mFOLFRINOX treatment combination of Oxaliplatin, Irniotecan, 5-flurouracil, and vitamin derivative (Folinic acid)"
15893680|NCT03699319|Drug|5-flurouracil|"Administered at 400 mg/m2 as bolus followed by a 46-hr infusion at 2400 mg/m2, starting immediately after completion of folinic acid and irinotecan
~Part of SOC mFOLFRINOX treatment combination of Oxaliplatin, Irniotecan, 5-flurouracil, and vitamin derivative (Folinic acid)"
15893681|NCT03699319|Drug|Folinic acid|"Administered at 400 mg/m2 given as a 90-min infusion immediately after oxaliplatin
~Part of SOC mFOLFRINOX treatment combination of Oxaliplatin, Irniotecan, 5-flurouracil, and vitamin derivative (Folinic acid)"
15893682|NCT03699306|Procedure|NG tube insertion method|a feeding tube called naso-gastric or NG tube were inserted through nostril inside the stomach randomly by one of three methods mentioned earlier
15893683|NCT03699293|Drug|celecoxib 200mg capsule|celecoxib 200mg twice a day for 4 weeks
15893684|NCT03699293|Drug|naproxen sodium 550mg tablet|naproxen sodium 550mg twice a day for 4 weeks
15893685|NCT03699293|Drug|Aspirin 81mg tablet|81mg aspirin for 4 weeks in the run-in period, and for 8 weeks during treatment and crossover period
15893686|NCT03699280|Other|Virtual Reality|Oculus Go VR device
15893687|NCT03699267|Other|US-guided Bilateral TAP block|
15893688|NCT03699254|Drug|Valganciclovir|"Valganciclovir is a L-valyl ester of ganciclovir that exists as a mix of 2 diastereomers. After administration, both are converted to ganciclovir by esterases. Ganciclovir is a synthetic analogue of 2'-deoxyguanosine, it inhibits replication of cytomegalovirus.
~In CMV-infected cells it's phosphorylated (phosphorylation is dependent on the viral kinase and occurs preferentially in virus-infected cells). Ganciclovir activity is due to inhibition of viral DNA synthesis by ganciclovir triphosphate."
15893689|NCT03699254|Drug|Ganciclovir|"Ganciclovir is a synthetic analogue of 2'-deoxyguanosine, it inhibits replication of cytomegalovirus.
~In CMV-infected cells it's phosphorylated (phosphorylation is dependent on the viral kinase and occurs preferentially in virus-infected cells). Ganciclovir activity is due to inhibition of viral DNA synthesis by ganciclovir triphosphate."
15893690|NCT03699241|Biological|BG505 SOSIP.664 gp140, adjuvanted|Dosage of 30ug, Intramuscular administration
15893691|NCT03699241|Biological|BG505 SOSIP.664 gp140, adjuvanted|Dosage of 100ug, Intramuscular administration
15893694|NCT03699215|Drug|Levosimendan|Upon arrival of the patient in the Coronary Unit, he will receive, in a randomized and double-blind manner, the 24-hour infusion of Levosimendan, without a loading dose, at a dose of 0.1 μg / kg / min or placebo. If the initial dose is tolerated and a greater hemodynamic effect is needed, the infusion rate can be increased to 0.2 micrograms / kg / min. The dose of Levosimendan infusion can be reduced to 0.05 μg / kg / min in case of clinical intolerance or systolic hypotension <90 mmHg.
15893695|NCT03699215|Drug|Placebos|continuous perfusion of 0.1 micrograms / kg / min for 24h. If the initial dose is tolerated and a greater hemodynamic effect is needed, the infusion rate can be increased to 0.2 micrograms / kg / min.
15893696|NCT03699202|Drug|AK0529|AK0529 is a novel compound being developed for the treatment of RSV infection. The capsule containing enteric coated AK0529 pellets will be orally administered to patients at one of a 100mg, 200mg or 300mg dose level.
15893697|NCT03699202|Drug|Placebo|The placebo is made with the same smell and appearance as AK0529 but without the active ingredients. The placebo supplements are composed of microcrystaline cellulose pellet.
15893698|NCT03699189|Behavioral|Immediate ANAIS|"ANAIS is a structured therapeutic education programme aimed at providing the patients with the necessary skills to manage their diabetes independently and confidently. The programme particularly promotes dietary freedom, in an intensive insulin regime, by enabling effective carbohydrate counting and accurate prandial insulin dose adjustment and avoiding hypoglycaemia.
~ANAIS was organised as a five day (Monday to Friday), seven-hour, outpatient programme using principles of adult education, with explicit learning objectives, in a group setting."
15893699|NCT03699176|Drug|Vilaprisan (BAY1002670)|2 mg, once daily, oral
15893700|NCT03699176|Drug|Placebo|Once daily, oral
15893701|NCT03699163|Diagnostic Test|Breath sample|Patients will be asked to give a sample of their breath, using the ReCIVA breath testing device. This involves performing tidal breathing whilst wearing a face mask for approximately 5 minutes. Breath (500mls at a flow rate of 200mls/min) is passed over thermal desorption tubes which absorb compounds of interest.
15893702|NCT03699137|Other|No interventions|No interventions
15893703|NCT03699124|Biological|FD MVA-BN|Vaccinations with a 0.5 mL dose of vaccine containing at least 0.5 x 10E8 Infectious Units (Inf.U)
15893704|NCT03699098|Diagnostic Test|TSH, T3, T4 and thyroid gland DVH|measuring thyroid functions and DVH parameters of thyroid gland
15893705|NCT03699085|Behavioral|ED-LINC|ED-LINC will include 1) A brief negotiated interview at the bedside with an emphasis on motivation to link to services 2) Pharmacotherapy including a discussion of opioid safety, take-home naloxone and initiation of buprenorphine from the ED for participants that are interested and eligible; 3) Longitudinal care management which will proceed for 3-months; and 4) Care plan in the Emergency Department Information Exchange (EDIE) system. This will be coupled with a study cell phone and a weekly supervisory case conference which is consistent with collaborative care principles.
15893706|NCT03699072|Device|DermaRep™ Wound Contact Device|Treatment of venous leg ulcers once weekly for 8 weeks along with standard of care dressings
15893707|NCT03699059|Other|ExeRTiOn|REHAB-online is an online weight gain prevention tool comprising of physical activity advice, dietetic advice, self-monitoring and tracking and behavioural change techniques. This resource is specific to kidney transplant patients and has been created by the research steering group including patient representation. During this study participants (both HCPs and patients) will have a one-off study visit to test and evaluate the online intervention.
15893708|NCT03699046|Procedure|Subchondroplasty and Knee Arthroscopy|Subchondroplasty® (SCP®) is a procedure performed along with minimally-invasive arthroscopy. The bone marrow lesion(s) will be located using pre-operative MRI combined with fluoroscopy (intra-operative X-ray) and a small, drillable AccuPort® Delivery Cannula will be placed in the appropriate position. The cannula will then be drilled into the bone marrow lesion(s) and a flowable, synthetic, calcium phosphate bone substitute (AccuFill® Bone Substitute Material, Zimmer Biomet) will be injected into the lesion(s). The calcium phosphate bone substitute will then harden, improve the structural integrity of the damaged subchondral bone, and will gradually be resorbed and replaced with new bone.
15893709|NCT03699046|Procedure|Knee Arthroscopy Alone|Knee arthroscopy is a surgical procedure that involves the orthopaedic surgeon making small incisions in the knee and then inserting a small camera into the joint. Following the insertion of the camera, multiple procedures can be completed to treat a number of different conditions such as repair or partial/complete removal of the meniscus, debridement, lavage, removal of a loose body among others.
15893710|NCT03699046|Biological|Subchondroplasty|Subchondroplasty® (SCP®) is a procedure performed along with minimally-invasive arthroscopy. The specific biological component of the procedure involves the injection of the AccuFill® Bone Substitute Material (Zimmer Biomet), which is a a flowable, synthetic, calcium phosphate bone substitute, into the bone marrow lesion(s).
15893711|NCT03699033|Radiation|2.5 Gy/fraction|Hypofractionated Intensity-Modulated Radiation Therapy (IMRT) Utilizing 2.5 Gy/Fraction to PET-avid Disease Combined with Carboplatin and Paclitaxel
15893712|NCT03699033|Drug|Carboplatin|"The doses of chemotherapy to be given concurrently with conformal radiotherapy will be weekly paclitaxel (45 mg/m2) and carboplatin (AUC=2), respectively.
~Consolidation chemotherapy with 2 cycles of carboplatin (AUC=6) and paclitaxel (200 mg/m2) should be administered following completion of concurrent chemoradiation."
15893713|NCT03699033|Drug|Paclitaxel|"The doses of chemotherapy to be given concurrently with conformal radiotherapy will be weekly paclitaxel (45 mg/m2) and carboplatin (AUC=2), respectively.
~Consolidation chemotherapy with 2 cycles of carboplatin (AUC=6) and paclitaxel (200 mg/m2) should be administered following completion of concurrent chemoradiation."
15893714|NCT03699020|Behavioral|Acceptance and Commitment Therapy (ACT)|Empirically based behavioral intervention that encourages acceptance of circumstances with commitment and behavioral change strategies to improve psychological flexibility.
15893715|NCT03699020|Other|Chronic Pain Education|Education materials about living with chronic pain developed by Weill Cornell Universitys Translational Research Institute for Pain in Later Life
15893716|NCT03699007|Behavioral|Graded Exposure Therapy (GET Living)|The protocol consists of 12 interdisciplinary sessions, 1-hour each, delivered twice a week, for an average of 6 weeks. Phase I-III are conducted with the psychologist, physical therapist, adolescent, and parent (as developmentally appropriate). Patient and parent will complete daily diaries and patients will wear the Actigraph throughout the duration of treatment.
15893818|NCT03698201|Other|Non-interventional|Translational, observational study
15893717|NCT03699007|Behavioral|Typical Pain Management (TPM)|The protocol consists of 12 multidisciplinary sessions, 1-hour each, delivered twice a week, for an average of 6 weeks. Sessions will alternate between psychological CBT sessions and Physical Therapy sessions. Patient and parent will complete daily diaries and patients will wear the Actigraph throughout the duration of treatment. The parent will also participate in 3 additional parent-only sessions with the psychologist to address parental coping skills.
15893718|NCT03698994|Other|Pharmacokinetic Study|Ancillary studies
15893719|NCT03698994|Drug|Ulixertinib|Given PO
15893720|NCT03698981|Behavioral|Mothers Moving towards Empowerment (MME)|"MME integrates 3 components: 1) psychoeducation regarding causes, transmission, and treatment of HIV re how adherence to ART and antenatal care acts to promote health for HIV+ women and PMTCT82,83. We will emphasize ART adherence spanning into PP as a maternal duty to raise a healthy child; 2) challenging stereotypes of HIV+ women, such as promiscuity, that threaten core aspects of being a good woman and hinder treatment adherence; 3) coping skills for HIV-related discrimination, i.e., rejection or abandonment by male partners leading to discontinuing treatment adherence and impacts on raising children."
15893721|NCT03698968|Device|Negative Pressure Wound Therapy|Single use disposable negative pressure system. The system is capable of delivering up to 80 mm Hg negative pressure to a wound or surgical incision site and managing low to moderate levels of exudate or fluid generated by the wound or incision. The therapy may be administered for up to 1 week.
15893722|NCT03698955|Other|Plant-based diet|Weekly instructions will be given to the participants in the intervention group about following the vegan diet.
15893723|NCT03698955|Other|Mediterranean Diet|Weekly instructions will be given to the participants in the intervention group about following the Mediterranean diet.
15893724|NCT03698942|Device|Reading of Automated Breast Ultrasound in conjunction with Screening Mammography|Reader performance when SoftVue automated breast ultrasound (SV) and digital screening mammography (DM) are combined, compared to screening mammography alone.
15893725|NCT03698929|Other|Dietary Effect of Cholesterol - Egg Phase|After the study entry, you will be assigned by chance, like the flip of a coin, to one of two groups. You will have an equal chance of being assigned to either group. Each group will be asked to consume baked goods daily. The two groups will consume the same baked goods, but in a different order. Each week, you will be given a week's worth of baked goods.
15893726|NCT03698929|Other|Dietary Effect of Cholesterol - Non-Egg Phase|After the study entry, you will be assigned by chance, like the flip of a coin, to one of two groups. You will have an equal chance of being assigned to either group. Each group will be asked to consume baked goods daily. The two groups will consume the same baked goods, but in a different order. Each week, you will be given a week's worth of baked goods.
15893727|NCT03698916|Drug|Celecoxib cream 8%|transdermal delivery of 8% Celecoxib
15893728|NCT03698903|Behavioral|Take a STAND 4 Health|The 4-week is comprised of several elements, including: (1) an in-person introductory session to acquaint the individuals with all intervention elements, customize to their preferences and describe the mHealth component of the intervention; (2) a website that will provide individualized feedback over time on the participant's scheduled breaks, sedentary time reduction, and sedentary patterns; (3) texts to serve as prompts and alert the participant to stand or move, with a goal of a 60 minute reduction per day, which are customized to the individual's schedule, personal preference and sedentary profile; and (4) two coaching phone calls to trouble shoot and problem solve implementation of the intervention.
15893729|NCT03698890|Device|Network-based home blood pressure monitor|A network-based home blood pressure monitor will be loaned to patients in the intervention group, who will be asked to monitor their blood pressure at least once every week using the network based home blood pressure monitor, which automatically uploads measured blood pressure readings to the portal for care managers (CM) to review blood pressure readings and provide updates to the patient on blood pressure control. If a patient's blood pressure is elevated, the CM can titrate medications over the phone and provide follow up tele-consultation and necessary treatment.
15893730|NCT03698877|Diagnostic Test|Brain Natriuretic Protein (BNP) and Procalcitonin (PCT) blood tests|"For patients with suspected infection, PCT levels will be drawn at the time of suspected infection and again at the start of the next HD treatment.
~For patients with shortness of breath, PCT and BNP levels will be drawn at the time of the complaint and again at the start of the next HD treatment."
15893731|NCT03698864|Drug|PCS499|PCS499 900mg twice a day with food
15893732|NCT03698851|Device|Guidor® and Guidor easy-graft® CRYSTAL|A compound of biphasic calcium phosphate, 60 % hydroxyapatite and 40 % beta-tricalcium phosphate. The beta-tricalcium phosphate component completely resorbs via physiological dissolution in 5-15 months, while the interconnected hydroxyapatite remains embedded in the implantation site and forms an integrated long term osteoconductive scaffold with new bone.
15893733|NCT03698851|Device|Guidor® and Guidor easy-graft® CLASSIC|Phase-pure beta-tricalcium phosphate that offers complete resorption via physiological dissolution in 5-15 months. This material has been used in oral surgery for more than 25 years and there are extensive research available on it.
15893734|NCT03698838|Device|McDESPOT|MRI sequence, mcDESPOT (multicomponent driven equilibrium potential of T1 and T2) that utilizes a computer model that takes T1 and T2 sequences and derives a quantitative value for the myelin content in the myelin sheath
15893735|NCT03698825|Drug|TEW-7197|TEW-7197 50mg tablets + Paclitaxel 80 mg/m2 D1, 8, 15 q 4 weeks TEW-7197 dose will be determined through this dose escalation study
15893736|NCT03698812|Combination Product|Colonoscope|take off specimen
15893737|NCT03698786|Behavioral|Exercise|Participants will be required to complete two, 8-hours trials (exercise & control) in a randomised order, preceded by 2 hours of preliminary testing (baseline) with no more than 14 days between conditions.
15893738|NCT03698773|Other|Access to routine information|Access to routine pain-control information
15893739|NCT03698773|Other|Access to website|Access to informational website: thepainlesspush.com
15893740|NCT03698760|Diagnostic Test|Olfactory test|"Olfactory test:
~All fragrances tested are kept in an airtight case protected from cold and heat.
~The test is done on a tablet and the data will be automatically saved. The first screen is about the administrative data, sex and age of the subject. Olfactory test: six odors among the fourteen are proposed in a randomized way."
15893741|NCT03698747|Device|McDESPOT|myelin specific MRI sequence (mcDESPOT) added to standard MRI sequence
15893941|NCT03697200|Other|Sham APA control|Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
15893743|NCT03698734|Drug|Placebo - Cap|primiparous women with missed abortion between(13 to 24 weeks) will receive 1 capsule of placebo in addition to misopristol
15893744|NCT03698721|Procedure|Transurethral Resection of Prostate|Transurethral resection of the prostate is a urological operation used to treat benign prostatic hyperplasia (BPH). It is performed by visualising the prostate through the urethra and removing tissue by electrocautery or sharp dissection with a resectoscope. This is considered the most effective treatment for BPH. This procedure is done with spinal or general anaesthetic. A triple lumen catheter is inserted through the urethra to irrigate and drain the bladder after the surgical procedure is complete. Outcome is considered excellent for 80-90% of BPH patients.
15893745|NCT03698708|Behavioral|CARES Intervention|A 12-week group-based telemedicine intervention to treat depression in parents/caregivers of children with T1D using a cognitive-behavioral approach.
15893746|NCT03698695|Drug|THN 201|THN 201: Donepezil 5 mg and Mefloquine 10 mg/d
15893747|NCT03698695|Drug|Donepezil|Donepezil 5 mg/d and Mefloquine placebo
15893748|NCT03698695|Drug|Placebo|Donepezil placebo and Mefloquine placebo
15893749|NCT03698682|Drug|Levofloxacin 500mg|One tablet per day for 7 days.
15893750|NCT03698669|Behavioral|Treating Opioid Patients' Pain and Sadness (TOPPS)|TOPPS involves an initial face-to-face meeting followed by regular phone meetings. In preliminary research, patients found this format to be convenient. The initial meeting includes the patient, the BHS and the PCP; the PCP then regularly receives treatment notes from the BHS. Also, the PCP, who has a longitudinal relationship with the patient, is encouraged to further reinforce TOPPS goals. After each TOPPS session, the BHS also mails a copy of the clinical note to the patient. Additionally, each participant is provided with a workbook that reviews the key elements of each treatment session and provides exercises for at-home practice of skills.
15893751|NCT03698669|Behavioral|Health Education (HE)|After an initial, brief, joint, in-person meeting with the BHS and primary care physician (PCP), patients have a session that discusses nutrition. For the next 5 telephone sessions, they choose from a menu of topics, including: a second session on nutrition; germs, colds and the flu; preventing cancer; diabetes; protecting your heart; getting a good night's sleep; complementary and alternative medicine; caffeine, or physical activity. This control condition was accepted by our participants in preliminary studies; it does not directly target functional impairment, and participants do not set tailored goals relating to their own values. The BHS will communicate with the PCP only if a participant shows signs of clinical deterioration.
15893752|NCT03698656|Behavioral|Spiritual Interview|Three patient interviews (45 to 60 minutes) will be conducted by the study nurse at the beginning of the study and approximately 2 and 4 month later, according to the program of the medical care. Each interview will be conducted according the active listening method of Carl Rogers.
15893753|NCT03698630|Drug|Prednisolone Sodium Phosphate|Prednesol 5mg Tablets (Phoenix Labs Ltd). Pink, circular, flat, bevel-edged scored tablets containing 5 mg of prednisolone as prednisolone sodium phosphate.
15893754|NCT03698630|Drug|Dexamethasone|"Dexamethasone 2 mg tablets (Organon Ireland Ltd). Round, 6 mm, flat, white tablet with the code XC/8 engraved on one surface and Organon* on the other containing 2 mg dexamethasone."
15893755|NCT03698617|Drug|HSK3486|For induction of general anesthesia In dose escalation cohort: Starting from 0.4mg/kg, up-titration dose by 0.1mg/kg until 0.8mg//kg or down-titration dose by 0.1mg/kg until 0.1mg/kg based on the efficacy and safety results.
15893756|NCT03698617|Drug|Propofol|For induction of general anesthesia
15893757|NCT03698604|Procedure|Hysterectomy|Total Laparoscopic Hysterectomy Total Abdominal hysterectomy
15893758|NCT03698591|Device|Transcranial magnetic stimulation task|Experimenters will employ a continuous theta-burst stimulation (cTBS) sequence using a figure-8 coil positioned tangentially to the scalp over the target coordinates. Experimenters have defined the target coordinates for stimulation (Montreal Neuroscience Institute coordinates -53, -53, 23) based on peak objective distancing activation in the left temporal parietal junction (TPJ) in previous fMRI studies using the same task.
15893759|NCT03698591|Device|Sham transcranial magnetic stimulation task|A sham version of the TMS intervention where subjects will receive a small electrical stimulation on the scalp via two small electrodes in conjunction with a TMS coil activation. The TMS coil will be reoriented to stimulate into the air away from the scalp, simulating traditional TMS, without inducing any current to the subject.
15893760|NCT03698578|Other|combat fight|Jiu-jitsu heating with light intensity was used for 5 minutes. The simulated fight protocol occurred in accordance with the rules of the Brazilian Confederation of Sports Jiu-Jitsu, excluding any types of finalization. In these cases, the athletes were separated and oriented to return immediately. Thus, maximum effort was advocated as well as, similar time of activity for all
15893761|NCT03698565|Other|Nerve stimulation of the ulnar nerve|"The intervention is the nerve stimulation of the ulnar nerve for evaluation / realization of PPI by videopupillometry.
~The realization of PPI and ANI measurements is carried out at the end of the surgical procedure, it implies a maintenance of the anesthesia for approximately 5 additional minutes."
15893762|NCT03698552|Biological|ADCT-602|Starting dose of ADCT-602: 30 μg/kg given by vein.
15893763|NCT03698539|Behavioral|hand gestures|We observe the use of spontaneous hand gestures in all the groups.
15893764|NCT03698526|Device|Samsung Gear VR, Galaxy S8, Applied VR App|Virtual Reality Experience
15893765|NCT03698513|Drug|BMS-986177|BMS-986177 capsule
15893766|NCT03698513|Other|Placebo (for BMS-986177)|BMS-986177 placebo match capsule
15893767|NCT03698513|Drug|Clopidogrel|Clopidogrel tablet
15893768|NCT03698513|Drug|Aspirin|Aspirin tablet
15893769|NCT03698500|Other|Removal of blood|10 ml of blood will be removed from a peripheral vene during routine diagnostical blood draw
15893770|NCT03698487|Other|Intervention|Pharmacist-led medication optimization intervention using an electronic tool (DBI Calculator©). The DBI Calculator is an electronic tool which calculates a score from the medication reconciliation list (medications taken prior to admission). It also creates a 'DBI report' which includes their full medication list, their DBI score, an explanation of the risks associated with their DBI score and highlighted medications which are contributing to their DBI score (that is, high risk medications which may be suitable for deprescribing).
15893771|NCT03698474|Drug|Natrium picosulfate / Magnesium citrate|bowel preparation formula
15893772|NCT03698474|Drug|Polyethylene glycol / Ascorbic acid|bowel preparation formula
15893773|NCT03698474|Drug|Natrium/ Kalium/ Magnesium sulfate|bowel preparation formula
15893774|NCT03698461|Drug|Atezolizumab|"1200mg IV on day1 before start of cycle 'atezolizuamb, bevacizumab + FOLFOX(Oxaliplatin, Levoleucovorin, 5-FU')
~840mg IV D1 of C1-12 (Cycle: every 2 weeks)"
15893775|NCT03698461|Drug|Bevacizumab|5mg/kg IV D1 of C1-12 (Cycle: every 2 weeks) at least 5 minutes after completion of atezolizumab
15893776|NCT03698461|Drug|Oxaliplatin|85mg/m2 IV D1 of C1-12 (Cycle: every 2 weeks)
15893777|NCT03698461|Drug|Levoleucovorin|200mg/m2 IV D1 of C1-12 (Cycle: every 2 weeks)
15893778|NCT03698461|Drug|5-FU|"5-FU Bolus: 400mg/m2 IV bolus D1 of C1-12 (Cycle: every 2 weeks)
~5-FU infusion: 2400mg/mg continuous IV infusion over 46hours D1-3 of C1-12 (Cycle: every 2 weeks)"
15893779|NCT03698448|Drug|OligoG Dry powder for inhalation|10 capsules Dry Powder for Inhalation, BID
15893780|NCT03698435|Drug|Ganciclovir|Intravenous ganciclovir + TDM
15893781|NCT03698435|Drug|Valganciclovir|Oral valganciclovir + TDM
15893782|NCT03698422|Diagnostic Test|Blood and urine samples|Subjects will be admitted to the Department of Nephrology, Herlev and Gentofte Hospital, Herlev, Denmark, for 24-hour observation with measurements of serum and urine at three-hour intervals.
15893783|NCT03698409|Other|Preserved saline in reconstitution of Botox|The intervention consists of using 4 ml of preserved saline for the reconstitution of OnabotuliniumtoxinA prior to its use in subjects with chronic migraine.
15893784|NCT03698396|Biological|Allogenic Islet Cell Transplantation|Transplantation of allogenic islet cells will be given to eligible patients, up to three times during the study, using cell quantities based on body weight.
15893785|NCT03698383|Drug|Trastuzumab biosimilars(Herzuma), Gedatolisib|"Trastuzumab biosimilar: Intravenously administered on Day 1 of every 21 day cycle at a dose of 6mg/kg (loading dose 8mg/kg at 1C)
~Gedatolisib: Intravenously administered on Day 1, 8 and 15 of every 21 day cycle at a dose of 180mg"
15893786|NCT03698370|Drug|Gallium Ga 68 DOTA-NeoBOMB1|Administered intravenously (IV)
15893787|NCT03698370|Device|Gallium Ga 68 PSMA-R2|Administered intravenously (IV)
15893788|NCT03698357|Behavioral|interactive video balance-based exercise|Interactive video balance-based exercise :10 minutes of warm up exercise, 30 minutes of Interactive video balance-based exercise and 5 minutes of cool down exercise.
15893789|NCT03698357|Behavioral|Conventional physiotherapy|conventional physiotherapy: 10 minutes of warm up exercise, 30 minutes conventional physiotherapy and 5 minutes of cool down exercise. Conventional physiotherapy contains rolling, sitting, balance exercise, standing, overground walking, facilitation of the paretic limbs, and so on.
15893790|NCT03698344|Other|Biodiesel exhaust exposure|Evaluation of sympathetic nervous system activity as assessed by microneurography recording during an acute exposure to dilute biodiesel exhaust via mask.
15893791|NCT03698331|Drug|Valbenazine|vesicular monoamine transporter 2 (VMAT2) inhibitor
15893792|NCT03698331|Drug|Placebo oral capsule|non-active dosage form
15893793|NCT03698318|Dietary Supplement|Tested product n°1|1 capsule (26% of gingerol/shogaol in 100 mg) to consume one time for each subject, at one experimental session (random assignment), with 250 mL of water (consumption at T0 time-point of the kinetic)
15893794|NCT03698318|Dietary Supplement|Tested product n°2|1 capsule (38.6% of gingerol/shogaol in 74.9 mg) to consume one time for each subject, at one experimental session (random assignment), with 250 mL of water (consumption at T0 time-point of the kinetic)
15893795|NCT03698318|Dietary Supplement|Tested product n°3|2 capsules (6.8% of gingerol/shogaol in 424.3 mg) to consume one time for each subject, at one experimental session (random assignment), with 250 mL of water (consumption at T0 time-point of the kinetic)
15893796|NCT03698318|Dietary Supplement|Tested product n°4|1 capsule (27% of gingerol/shogaol in 104.9 mg) to consume one time for each subject, at one experimental session (random assignment), with 250 mL of water (consumption at T0 time-point of the kinetic)
15893797|NCT03698318|Dietary Supplement|Tested product n°5|6 capsules (1.6% of gingerol/shogaol in 1806.25 mg) to consume one time for each subject, at one experimental session (random assignment), with 250 mL of water (consumption at T0 time-point of the kinetic)
15893798|NCT03698305|Drug|ASP5354|Intravenous
15893799|NCT03698305|Drug|Placebo|Intravenous
15893800|NCT03698292|Drug|Itopride|Prokinetic Drug
15893801|NCT03698292|Drug|Metoclopramide 10mg|Prokinetic Drug
15893802|NCT03698279|Biological|High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 30 μg (split-virion, inactivated)|Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM
15893803|NCT03698279|Biological|High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 45 μg, (split-virion, inactivated)|Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM
15893804|NCT03698279|Biological|High-Dose Quadrivalent Influenza Vaccine (QIV-HD) 60 µg (split-virion, inactivated)|Pharmaceutical form: Suspension for injection in pre-filled syringe Route of administration: IM
15893805|NCT03698279|Biological|Fluarix Quadrivalent Influenza vaccine (Unadjuvanted QIV-SD) (Inactivated)|Pharmaceutical form: Solution for injection Route of administration: IM
15893806|NCT03698279|Biological|FLUAD Pediatric (adjuvanted TIV) (Surface Antigen, Inactivated)|Pharmaceutical form: Solution for injection Route of administration: IM
15893807|NCT03698266|Procedure|Needle knife fistulotomy|A needle knife fistulotomy uses a tiny knife to cut directly into the ampulla to gain access to the biliary system in patients undergoing ERCP
15893808|NCT03698253|Drug|Regorafenib|Regorafenib is administered at dose of 120 mg daily for 3 weeks in a 4-week cycle
15893809|NCT03698253|Genetic|UGT1A1 genotyping (TA6/TA6)|The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 260 mg/m2
15893810|NCT03698253|Genetic|UGT1A1 genotyping (TA6/TA7)|The dosage of irinotecan in FOLFIRI is escalated from 180mg/m2 to 240 mg/m2
15893811|NCT03698253|Genetic|UGT1A1 genotyping (TA7/TA7)|The dosage of irinotecan in FOLFIRI is escalated from 120mg/m2 to180 mg/m2
15893812|NCT03698240|Behavioral|Mindfulness-based program|The program includes 9 mindfulness-based sessions for children and their parents.
15893813|NCT03698227|Drug|Olaratumab|iv infusion
15893814|NCT03698227|Drug|Dexrazoxane|iv infusion
15893815|NCT03698227|Drug|Doxorubicin|iv infusion
15893816|NCT03698214|Other|reversed shock index < 1|Among patients with isolated TBI, those with an RSI < 1 had higher mortality
15893817|NCT03698214|Other|reversed shock index ≥ 1|Among patients with isolated TBI, those with an RSI ≥ 1 had lower mortality
15911419|NCT03563144|Biological|ETBX-051|Ad5 [E1-, E2b-]-Brachyury vaccine
15893819|NCT03698188|Procedure|Injectable platelet-rich fibrin|A blood sample will be drawn from the patient, centrifuged at 700 rpm for 3 minutes and the upper yellow fluid will be collected by a plastic syringe, avoiding the inclusion of the red blood cells underneath, and will be introduced within the root canal.
15893820|NCT03698188|Procedure|Platelet-rich plasma|A blood sample will be drawn from the patient, centrifuged at 3000 rpm for 10 minutes and the upper yellow fluid will be collected by a plastic syringe, avoiding the inclusion of the red blood cells underneath, and will be introduced within the root canal.
15893821|NCT03698175|Behavioral|Three good things exercise|Participants are asked to remember each evening three things that went well during their day and to write them down in a journal including a short explanation of why they think each of them has happened.
15893822|NCT03698175|Behavioral|Placebo exercise|Participants are asked to briefly recall a childhood memory (no further specification) and to write it down including a short explanation why they think it has happened.
15893825|NCT03698149|Device|PMT/Blackrock Combination Device|PMT Subdural Cortical Electrodes/Blackrock NeuroPort Array and NeuroPort System
15893826|NCT03698136|Other|Stimulation of denervated muscles|The study investigates the effect of electrical stimulation on denervated muscles in the forearm and hand regarding muscle structure and thickness. The study will be performed on tetraplegics who have either paralysed the wrist extensor, the short thumb spreader or the muscle between the thumb and index finger.The study lasts 12 weeks and consists of an ultrasound examination at the beginning and end of the study and an intermediate stimulation phase.The stimulation takes place either during an inpatient stay or at home for 12 weeks, 5 times a week 33 minutes.
15893827|NCT03698123|Other|Dietary Modification|Participants will be provided with meals, snacks and drinks with specific macronutrient compositions and encouraged to only eat and drink study meals, snacks and drinks and to avoid eating after 10:00 hours.
15893828|NCT03698110|Behavioral|Intervention Group|PUEDES program included eight hours in groups and activities to practice at home.
15893829|NCT03698097|Other|patient satisfaction survey|Patient survey completed in a paper or survey monkey based internet version accessible via a QR code or link
15893830|NCT03698084|Procedure|venepuncture|sample collection for analysis
15893831|NCT03698084|Procedure|nasopharyngeal swab|sample collection for analysis
15893832|NCT03698071|Biological|blood sample|30 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
15893833|NCT03698071|Biological|urine sample|6 ml
15893834|NCT03698058|Dietary Supplement|Toddler milk|Commercially available toddler milk
15893835|NCT03698045|Drug|PRO-143 Ophthalmic Solution|PRO-143 Ophthalmic Solution applied four times per day (C/6 hours) during 10 days.
15893836|NCT03698032|Dietary Supplement|Water|Participants will consume water only
15893837|NCT03698032|Dietary Supplement|1.5 oz Pistachios|Participants will consume water plus 1.5 oz of pistachios as the intervention
15893838|NCT03698032|Dietary Supplement|3.0 oz Pistachios|Participants will consume water plus 3.0 oz of pistachios as the intervention
15893841|NCT03698006|Drug|Ropivacaine 0.5% Injectable Solution|Tibial nerve block with 10ml of Ropivacaine 0.5%
15893842|NCT03698006|Drug|Ropivacaine 0.2% Injectable Solution|Infiltration with 25ml of Ropivacaine 0.2% in the posterior knee capsule
15893843|NCT03697993|Drug|Fosfomycin tromethamine|Administered orally as 3-gram single-dose sachet into 3-4 ounces (1 / 2 cup) of cool water; each dose must be taken immediately after dissolving in water. Hot water should not be used to dissolve fosfomycin. It may be taken either with or without food for normal kidney function. If Creatinine Clearance (CrCl) is less than 20 mL/min, fosfomycin should be taken as 3 grams every other day.
15893844|NCT03697993|Drug|Levofloxacin|750 mg is administered orally as one tablet once daily with or without food for normal kidney function. If Creatinine Clearance (CrCl) is 20-49 mL/min, 750 mg should be taken every other day. If on subsequent testing post-randomization, the Creatinine Clearance (CrCl) is less than 20 mL/min, followed by the dose is 500 mg every other day.
15893845|NCT03697980|Device|HeartWare Ventricular Assist Device|The HVAD is an implantable centrifugal rotary blood pump that is implanted in the pericardial space and is designed to provide up to 10 L/min of blood flow from the left ventricular to the aorta. The HVAD System is comprised of three major components: the HVAD (pump) with inflow and outflow conduits, a Controller (microprocessor unit that controls the operation of the HVAD), and power sources (AC and DC power adapters that provide power to the Controller and implanted HVAD).
15893846|NCT03697967|Procedure|Delayed cord clamping|Umbilical cord clamped at 2 minutes
15893847|NCT03697954|Device|full stage implantation of sacral neuromodulation|full stage implantation of sacral neuromodulation for overactive bladder and urge incontinence
15893848|NCT03697941|Procedure|Percutaneous arteriotomy closed using a plug-based arteriotomy closure device|Percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA, Essential Medical Inc., Malvern, Pennsylvania).
15893849|NCT03697941|Procedure|Surgical cut-down and arterial puncture under direct vision|Surgical cut-down and arterial puncture under direct vision.
15893850|NCT03697928|Other|Exercise metabolism|Participants will perform a series of exercises inside and outside the MRS/MRI scanner.
15893851|NCT03697915|Device|Experimental|Conventional physical therapy was administered to the control group and was aimed at achieving sitting balance in the first phase; once sitting balance could be achieved, we aimed at achieving standing balance in the second phase. Once standing balance was also achieved, supported and unsupported ambulation was commenced in the final phase.
15893880|NCT03697655|Drug|Daratumumab 20 MG/ML [Darzalex]|Daratumumab dose 16 mg/kg body weight to be administered as an IV infusion. treatment given until clinical progression or SPR but no longer than 73 weeks
15893881|NCT03697642|Procedure|With nasopharyngeal airway|Nasopharyngeal airway is previously inserted into selected nostril. NG tube is properly lubricated and placed through Nasopharyngeal airway.
15893882|NCT03697642|Procedure|Without nasopharyngeal airway|NG tube is properly lubricated and placed into selected nostril
15893852|NCT03697902|Diagnostic Test|Ultrasonographic Measurement on Fetal cisterna magna length|"The length measurement on the fetal cisterna magna (CM) with an angle of 0° between the transducer and the axial cerebellar plane of the fetal head (midline structures will be perpendicular to the ultrasound beam). After that, CM will be measured again after moving the transducer approximately 30° towards the fetal occiput.
~Measurements will be performed on the axial cerebellar plane using internal landmarks including the cavum septi pellucidi, thalamus, third ventricle, cerebral peduncles and cerebellar hemispheres.The anteroposterior measurement will be made between the posterior border of the cerebellar vermis and the internal face of the occipital bone.
~All the ultrasonography examinations were performed abdominally, using 3-5 megahertz (MHz) transducers."
15893853|NCT03697889|Drug|Naproxen sodium (test product)|Participants will be administered single doses of 275 mg Naproxen sodium (test product) tablet orally.
15893854|NCT03697889|Drug|Naproxen sodium (reference product)|Participants will be administered single doses of 275 mg Naproxen sodium (reference product - Nalgesin) tablet orally.
15893855|NCT03697876|Drug|PRO-165|PRO-165 Chondroitin sulfate 0.18% / sodium hyaluronate 0.2%, ophthalmic gel. Prepared by Sophia Laboratories, S.A. of C.V., Zapopan, Jalisco, Mexico.
15893856|NCT03697876|Drug|Artelac|Artelac® Nightime Gel. 0.2% Carbomer, ophthalmic gel. Made in Germany by: Dr. Gerhard Mann Chem Pharm. Imported and marketed by: Bausch & Lomb México, S.A. de C.V.
15893857|NCT03697863|Procedure|Noninvasive Respiratory Support|Noninvasive Respiratory Support delivered by conventional flow triggered ventilation or neurally triggered ventilatory assist
15893858|NCT03697850|Drug|Atezolizumab|Atezolizumab after adjuvant radio-chemotherapy for the treatment of patients with muscle-invasive bladder cancer not eligible for radical cystectomy
15893859|NCT03697837|Behavioral|Parent Management Training|The online digital parent training (DPT) program consists of 8 self-guided courses that take approximately 10 minutes to complete and include text and animated parent-child simulations. The courses are designed to closely parallel the content of existing evidence-based parent management training approaches that exist in numerous parenting books.
15893860|NCT03697824|Drug|GSK3377794|GSK3377794 is genetically engineered NY-ESO-1 Specific (c259) T cells.
15893861|NCT03697824|Drug|Pembrolizumab|Pembrolizumab will be administered at a dose of 200 mg once every 3 weeks for adults and 2 mg/kg (up to 200 mg) once every 3 weeks for children.
15893862|NCT03697824|Drug|Fludarabine|Fludarabine will be used as a lymphodepleting chemotherapy.
15893863|NCT03697824|Drug|Cyclophosphamide|Cyclophosphamide will be used as a lymphodepleting chemotherapy.
15893864|NCT03697811|Drug|DE-117 Ophthalmic Solution|Interventional treatment will be made with DE-117 Ophthalmic Solution 0.002% once daily in the evening for the duration of the 3 month treatment period.
15893865|NCT03697798|Biological|Boostrix®-IPV combination vaccine|A licensed aP (acellular) booster vaccine developed by GlaxoSmithKline.
15893866|NCT03697785|Device|Beacon Care System|Beacon has been developed by Mermaid Care in Denmark. BEACON is a critical care ventilation assist system (http://beaconcaresystem.com/beacon-5/), which potentially enables better ventilation strategies and a more efficient patient care workflow. As an add-on to standard ventilation systems it provides ventilation recommendations 24/7 based on non-stop, personalised monitoring/diagnostics of patients. Based on unique mathematical algorithms and physiological models, it recommends changes in ventilation settings, supporting the critical decision-making processes.
15893867|NCT03697759|Other|Usual care + selfBACK|"The selfBACK intervention is a digital Decision Support System (DSS) for self-management of LBP provided to the participant via a smartphone app (selfBACK app). In addition, the participant is provided with a step-detecting wristband (Xiaomi Mi Band 2) that interacts with the selfBACK app.
~The DSS provides individually tailored self-management plans including content from three categories; 1) information/education, 2) physical activity monitoring through wearing the step-detecting wristband, and 3) strength and flexibility exercises. The weekly plans are individually tailored to the specific patient, using the data available from the patient, and each week the patients report back their progress on physical activity (step count) and exercise (volume completed). These data are matched with the patients follow-up data to create a self-management plan that is up to date and adaptable to variation in health-status of the individual patient."
15893868|NCT03697746|Drug|paracetamol|paracetamol 1000 mg vial
15893869|NCT03697746|Drug|Dexketoprofen Trometamol|dexketoprofen trometamol 50 mg bulb
15893870|NCT03697746|Drug|Ibuprofen|ıbuprofen 400 mg vial
15893871|NCT03697733|Procedure|fractional curettage|Fractional curettage under TIVA by used oral Etoricoxib120 mg at 30 minutes before fractional curettage and then added intravenous Propofol 2 mg/kg when start the procedure or Intravenous Fentanyl 1 microgram/kg and Propofol 2 mg/kg when start the procedure
15893872|NCT03697720|Drug|Naproxen|Participants will take naproxen 500mg BID before and for the first 3 days of their period.
15893873|NCT03697707|Biological|DCP-001|allogeneic dendritic cell vaccine
15893874|NCT03697694|Dietary Supplement|500mg of Aronox® >40% polyphenol aronia extract|Name: Aronia PE 40% polyphenols Description: Powdered extract obtained from aronia berries (Aronia melanocarpa) Dosage form: Capsule (opaque, beige, size 00) Strength: 500 mg aronia extract Regimen 1 capsule, once a day with breakfast (except on days when attending the laboratory) Batch number: As per label Expiry Date: As per label Manufacturer: NATUREX / Virage sante
15893875|NCT03697694|Other|Placebo|Name: Placebo Description: Identical formulation as the treatment consisting of colored maltodextrin using artificial colors Dosage form: Capsule (opaque, beige, size 00) Strength: 500 mg placebo Regimen 1 capsule, once a day with breakfast (except on days when attending the laboratory) Batch number: As per label Expiry Date: As per label Manufacturer: NATUREX (Advance nutraceutical) / Virage sante
15893876|NCT03697681|Drug|Tranexamic acid|Intravenous infusion of Tranexamic acid(mixed with normal saline) at the dose of 10mg/kg(body weight) for 20 min after induction of anesthesia and then administration another 1mg/kg/hr(body weight) of Tranexamic acid(mixed with normal saline) until the end of the operation.
15893877|NCT03697681|Drug|0.9% NaCl (normal saline)|The same amount of normal saline solution without the addition of tranexamic acid is administered in the same manner as the experimental group(Tranexamic acid intervention group).
15893878|NCT03697668|Drug|Imatinib|triple combination for the treatment of malaria
15893879|NCT03697668|Drug|Dihydroartemisinin-piperaquine|standard malaria treatment
15893937|NCT03697239|Drug|Gemcitabine|1000mg/m2 in 500*mL over 30 minute IV infusion on days 1 and 8 repeated every 21 days
15893883|NCT03697629|Drug|Daratumumab|"Patients will receive daratumumab, in the following schedule:
~Daratumumab 8mg/kg in 500 mL over 4 hours Cycle 1 Day 1, Daratumumab 16mg/kg in 500 mL over 90 minutes (20% of dose given in first 30 minutes and remaining 80% of dose given over 60 minutes) Cycle 1 Days 8, 15 and 22; Cycle 2 Days 1, 8, 15, and 22, and on Days 1 and 15 for Cycles 3-6."
15893884|NCT03697616|Device|Ridge augmentation with sticky bone and GBR|"Autogenous particulate bone will be harvested and a mixture of autogenous particulate and anorganic bovine bone mineral will be prepared at a ratio of 1:1
~Venous blood will be drawn from patients' forearm and centrifuged at 2500 RPM/3 minutes and 4000 RPM/15 minutes to produce autologous fibrin glue and concentrated growth factors membrane, respectively
~Sticky bone will be prepared by adding autologous fibrin glue to the particulate mixture, placed onto the defect and covered by the prepared concentrated growth factors membrane
~For guided bone regeneration the particulate mixture will be placed onto the defect and covered by resorbable collagen membrane
~Periosteal releasing incision will be done to provide flap advancement for tension free closure
~Closure will be done using horizontal mattress and interrupted 4/0 polypropylene sutures"
15893885|NCT03697603|Drug|Brexpiprazole|Tablets, Oral, once daily, 14 weeks
15893886|NCT03697603|Drug|Placebo|Tablets, Oral, once daily, 14 weeks
15893887|NCT03697590|Drug|No curettage|Standard PDT without curettage
15893888|NCT03697590|Drug|Curettage|Standard PDT
15893889|NCT03697577|Diagnostic Test|CT scans|Patients will undergo CT or PETCT as part of their standard of care
15893890|NCT03697577|Diagnostic Test|DEXA scan|Patients will undergo DEXA scan to measure body fat mass. This is part of proposed study.
15893891|NCT03697564|Drug|Gemcitabine|1000 mg/m2 IV on days 1, 8, and 15 Q4W
15893892|NCT03697564|Drug|Nivolumab 10 MG/ML Intravenous Solution [OPDIVO]|480mg IV on Day 1 Q4W
15893893|NCT03697564|Drug|Cabiralizumab|4mg/kg IV on day 1 and 15 Q4W
15893894|NCT03697551|Drug|Satoreotide trizoxetan|Subjects will receive a single dose of Satoreotide trizoxetan consisting of a peptide mass up to 45 μg, with a radioactivity range of 150-200 MBq. Satoreotide trizoxetan is intended for diagnostic use as a Positron emission tomography/computed tomography (PET/CT) tracer for the imaging of tumours expressing SSTR2.
15893895|NCT03697538|Procedure|Nerve Block for pain control post-revision total knee arthroplasty|A 20g catheter will be introduced and advanced 2-3 cm beyond the tip of the needle under ultrasound visualization. After needle withdrawal, catheter placement will be checked by visualizing local anesthetic spread under ultrasound. 0.5% ropivacaine will be used for catheter placement. At the conclusion of surgery, the catheters will be connected to a pump that will infuse ropivacaine 0.2% at 6 mL/hr with a patient controlled bolus of 5mL and a lockout of 30 minutes.
15893896|NCT03697525|Device|Vibration|Low-amplitude rMV (frequency 100 Hz; amplitude range 0.2-0.5 mm) is applied over the flexor carpi radialis and the biceps brachii for the upper limb treatment, and/or over the quadriceps femoris for the lower limb treatment, by means of a specific commercial device (Cro®System, NEMOCOsrl).
15893897|NCT03697512|Drug|Ibrutinib|capsules for oral intake in a dosage of 560 mg (four capsules) daily
15893898|NCT03697512|Drug|Rituximab|Concentrate solution for infusion - intravenous use; Solution for injection - subcutaneous use.
15893899|NCT03697499|Combination Product|fish oil and acute ozone exposure|The participants will take fish oil (2.2 g/day, two 1.1-g capsules daily) in divided doses. Two hour ozone exposure (200 ppb ozone) will be conducted in a chamber after four weeks of supplementation.
15893900|NCT03697499|Combination Product|fish oil and sham exposure|The participants will take fish oil (2.2 g/day, two 1.1-g capsules daily) in divided doses. Two hour shame exposure (0 ppb ozone) will be conducted in a chamber after four weeks of supplementation.
15893901|NCT03697499|Combination Product|soy oil and acute ozone exposure|The participants will take soy oil (2.2 g/day, two 1.1-g capsules daily) in divided doses. Two hour ozone exposure (200 ppb ozone) will be conducted in a chamber after four weeks of supplementation.
15893902|NCT03697499|Combination Product|soy oil and sham exposure|The participants will take soy oil (2.2 g/day, two 1.1-g capsules daily) in divided doses. Two hour shame exposure (0 ppb ozone) will be conducted in a chamber after four weeks of supplementation
15893903|NCT03697486|Behavioral|diet with different composition|"Participants should not eat within the last 10 hours. Participants could drink mineral water up to 2 hours before intervention. Breakfast given is a milk-based formula which has to be finished within 15 minutes, and subjects could only consume 600 mL of mineral water within the next 4 hours after intervention. Participants' blood was taken before intervention, and 15, 60, 120, and 180 minutes after intervention, then examined in laboratory to measure ghrelin and PYY level. Breakfast given is adjusted to participants' energy requirement. Energy requirement is calculated by adding basal metabolic rate (BMR) with additional energy from physical activity. Different composition of protein, carbohydrate and fat were given to each arm depends on their group.
~After 4 hours, participants were given ad libitum meal. After the participants done eating, the calorie in meal taken by participants was measured."
15893904|NCT03697473|Other|Nordic hamstring exercise|The exercise protocol consisted of the following sets and repetitions Week 1 - 2 sessions with 2 sets of 6 repetitions. Week 2 - 2 sessions with 3 sets of 6 repetitions Week 3 - 2 sessions with 4 sets of 8 repetitions. Week 4 - 2 sessions with 4 sets of 10 repetitions.
15893905|NCT03697473|Other|Hip extension exercise|The exercise protocol consisted of the following sets and repetitions Week 1 - 2 sessions with 2 sets of 6 repetitions. Week 2 - 2 sessions with 3 sets of 6 repetitions Week 3 - 2 sessions with 4 sets of 8 repetitions. Week 4 - 2 sessions with 4 sets of 10 repetitions.
15893906|NCT03697460|Drug|INCB018424|INCB018424 PHOSPHATE CREAM 1.5%, topical application, twice daily on lesions of cutaneous LP.
15893907|NCT03697447|Procedure|Endermotherapy|Endermotherapy massage (mechanic massage) of burn scar
15893908|NCT03697434|Behavioral|Palliative Care referral|Individuals with Parkinson disease identified as having specific uncontrolled symptoms or critical events will undergo standardized referral to palliative care, who will provide supportive care. During the palliative care referral, participants and their care partners may discuss symptoms, disease burden (physical, emotion, financial, and psychological), quality of life, goals of care, and advance directive completion. Palliative care specialists may recommend interventions to manage bothersome symptoms or to improve disease burden for both participants and care partners.
15893938|NCT03697226|Drug|Topical ABI-1968|Multiple Doses of Topical ABI-1968 Cream with 4 once weekly doses administered in up to 5 Cohorts
15893939|NCT03697213|Other|Online study|20 hypothetical patient summaries
15893909|NCT03697421|Other|Relationship Education|"We will provide the following 4 activities: 1) marriage and relationship education [using a modified version of the empirically supported Loving Couples, Loving Children (LCLC); 2) pre-marital education and marriage skills; 3) marriage enhancement and marriage skills for married couples; and 4) divorce reduction and relationship skills.
~All couples will be expected to participate in 24 hours of core relationship education workshops (including parenting education). Since parental financial support represents a core element of family stability, relationship education workshops will address motivation for providing financial support through employment for all couples (employed and unemployed) as well as how to manage conflicts over money. All couples will be invited to supplemental workshops (with couples from other cohorts) on topics of specialized interest, including employment services and financial literacy (i.e. budgeting, debt, etc.)."
15893910|NCT03697421|Other|Employment Services|For couples in need of job search, job retention, and career advancement services, we will provide employment services.
15893911|NCT03697408|Drug|Itacitinib|A JAK 1 selective small molecule inhibitor
15893912|NCT03697408|Drug|Everolimus|A mammalian target of rapamycin (mTOR) inhibitor
15893913|NCT03697395|Diagnostic Test|Lung transplant recipient without MRI imaging|Patients who received lung transplant and undergoing surveillance follow-up at 1, 3, 6, 12, 24 months after the date of lung transplant, but without consenting to be evaluated by hyperbolized gas MRI. Bronchoscopy sampling will be performed per usual lung transplant team protocol.
15893914|NCT03697395|Drug|Lung transplant recipient with MRI imaging|Patients who received lung transplant and undergoing surveillance follow-up at 1, 3, 6, 12, 24 months after the date of lung transplant and with consenting to be evaluated by hyperbolized has MRI. Bronchoscopy sampling will be guided by the results of the hyper polarized gas MRI, different from the usual lung transplant team protocol. Administration of hyper polarized gas MRI is under FDA regulation by IND #129769 (PI, Yun Michael Shim, MD)
15893915|NCT03697382|Behavioral|Very Low Steps|Subjects will have a 2-day control period during which step count and diet will be controlled for and recreated for the other trials. Following this 2-day period, they will undergo the Very Low Stepping trial with the acute bout of exercise on day 2. Day 3 will consist of the lipid tolerance test to determine the ability of the body to clear triglycerides.
15893916|NCT03697382|Behavioral|Low Steps|Subjects will have a 2-day control period during which step count and diet will be controlled for and recreated for the other trials. Following this 2-day period, they will undergo the Low Stepping trial with the acute bout of exercise on day 2. Day 3 will consist of the lipid tolerance test to determine the ability of the body to clear triglycerides.
15893917|NCT03697382|Behavioral|Moderate Steps|Subjects will have a 2-day control period during which step count and diet will be controlled for and recreated for the other trials. Following this 2-day period, they will undergo the Moderate Stepping trial with the acute bout of exercise on day 2. Day 3 will consist of the lipid tolerance test to determine the ability of the body to clear triglycerides.
15893918|NCT03697356|Drug|Lenalidomide, Bortezomib, Rituximab, Dexamethasone|"step 1; R-VRD induction : rituximab, bortezomib, lenalidomide, and dexamethasone induction
~Rituximab 375 mg/m2 intravenous on day 1
~Bortezomib 1.3mg/m2 subcutaneous on day 1, 8, 15
~Lenalidomide 15mg p.o on day 1-21
~Dexamethasone 20 mg/m2 intravenous or p.o on day 1-4
~Step 2 ; Maintenance Beginning 8 weeks after completion of induction therapy, patients receive lenalidomide 10mg once day 1-21 for 4 weeks. Treatment repeats every 1 months for 24 months."
15893919|NCT03697343|Radiation|Radiosurgery|Radiosurgery with 1 x 18 Gy (2-3 cm) or 1 x 15 Gy (3-4 cm)
15893920|NCT03697343|Radiation|Fractionated stereotactic radiotherapy|Fractionated stereotactic radiotherapy with 12 x 4 Gy and 2 mm
15893921|NCT03697330|Drug|Ringer lactate|"Randomization will be done using computer generated table of random numbers in a 1:1 ratio and will be conducted using sequentially numbered, opaque and sealed envelope. The trial will be planned that neither the doctors (investigators) nor the patients will be aware of the group allocation and amount of fluid received. Intraoperative and postoperative data collections will be achieved by the same blinded anesthiologist.
~Patients will be randomly allocated into two groups:
~Group L: 40 patients who will be subjected to ''liberal approach of intraoperative 18-20 ml/kg/h of Ringer's lactate starting from conduction of spinal anesthesia.
~Group R: 40 patients who will be subjected to ''restrictive approach of intraoperative 4-6 ml/kg/h of Ringer's lactate starting from conduction of spinal anesthesia.
~Blood loss will be replaced if more than 500 ml in a ratio of 3 ml crystalloid: 1 ml blood."
15893922|NCT03697317|Behavioral|Televideo Lifestyle Coaching|Six month total intervention: Three months of weekly 1-hour televideo healthy lifestyle coaching sessions involving 30 minutes of structured physical activity and 30 minutes of nutrition education and daily healthy lifestyle habit tracking. This is followed by 3 months of healthy lifestyle habit tracking only.
15893923|NCT03697317|Behavioral|Enhanced Usual Care|Six months of healthy lifestyle habit tracking with access to written diet and physical activity materials.
15893924|NCT03697304|Drug|BI 754091|Solution for infusion
15893925|NCT03697304|Drug|BI 754111|Solution for infusion
15893926|NCT03697304|Drug|BI 836880|Solution for infusion
15893927|NCT03697291|Device|PS wire|The wiring connection used to convey ECG signal from inside the body
15893928|NCT03697278|Device|Smith medical CADDsolis|This group will be monitoring from a network.
15893929|NCT03697265|Drug|Sepranolone (UC1010) low dose|Subcutaneous (SC) administration
15893930|NCT03697265|Drug|Sepranolone (UC1010) high dose|Subcutaneous (SC) administration
15893931|NCT03697265|Drug|Placebo|Subcutaneous (SC) adminstration
15893932|NCT03697252|Drug|Xanomeline and Trospium Chloride Capsules|Xanomeline 50 mg/trospium 20 mg BID on days 1-2 followed by xanomeline 100 mg/trospium 20 mg BID on days 3-7. The dose is increased to xanomeline 125 mg/trospium 30 mg BID on days 8-34 unless the subject is experiencing adverse events from the xanomeline 100 mg/trospium 20 mg dose. Subjects who were increased to xanomeline 125 mg/trospium 30 mg will have the option to return to xanomeline 100 mg/trospium 20 mg depending on clinical response and tolerability. Dosing must not change after Visit 7 of the study (at 21 ± 2 days of dosing) and may be decreased for tolerability reasons no more than once during the study.
15893933|NCT03697252|Drug|Placebo Capsules|Placebo Capsules
15893934|NCT03697239|Drug|Ascorbic Acid|25, 37.5, 56.25 or 75 grams/m2
15893935|NCT03697239|Drug|Paclitaxel protein-bound|125mg/m2 over 30 minute IV infusions on days 1 and 8 repeated every 21 days
15893936|NCT03697239|Drug|Cisplatin|25mg/m2 in 500*mL of NS over 60minute IV infusion on days 1 and 8 repeated every 21 days
15893942|NCT03697200|Other|Education control|Participants in the Education Control will receive four, 15-minute weekly individual sessions in which the scheduling and duration of interaction with the study staff are identical to the APA and Sham interventions. Materials will be tailored so that they can be delivered within 15 minutes for each session
15893943|NCT03697187|Drug|rhC1INH|Recombinant human C1 inhibitor
15893944|NCT03697174|Other|200 ppb ozone group|The exposure group will be exposed to 200 ppb ozone in a chamber for 2 hours while alternating 20-min rest and 10-min exercise periods. The exercise workload will be adjusted to achieve the targeted ventilation of 25 ~ 27 L/min(approximately equal to 15 ~ 18L/min/m2 body surface area). The temperature and relative humidity in the chamber will be maintained at 22±1℃ and 55%±5%, respectively.
15893945|NCT03697174|Other|0 ppb ozone group|The control group will be exposed to 0 ppb ozone in a chamber for 2 hours while alternating 20-min rest and 10-min exercise periods. The exercise workload will be adjusted to achieve the targeted ventilation of 25 ~ 27 L/min(approximately equal to 15 ~ 18L/min/m2 body surface area). The temperature and relative humidity in the chamber will be maintained at 22±1℃ and 55%±5%, respectively.
15893946|NCT03697161|Drug|OV101 (gaboxadol)|OV101 (gaboxadol)
15893947|NCT03697148|Diagnostic Test|Multiparametric Magnetic Resonance Imaging|Undergo mpMRI
15893948|NCT03697135|Behavioral|Respondent Driven Sampling|Participants are asked to invite contacts that they previously injected with to take a test for hepatitis C
15893949|NCT03697122|Device|Heated Humidified Breathing Circuit and Forced Air Blanket|"Heated humidified breathing circuits (ANAPOD) will be set up and managed by respiratory therapist in standard fashion defined by the manufacturer. Temperate will be set at 41C.
~Forced air warming blankets will be set at 42C for duration of rewarming."
15893950|NCT03697109|Drug|Relacorilant|Relacorilant is supplied as 100 mg capsules for oral dosing.
15893951|NCT03697109|Other|Placebo|Placebo matched to study drug
15893952|NCT03697096|Other|Routine Care|Routine Antibiotic Stewardship Arm - Continuation of all antibiotic stewardship activities in accordance with national standards.
15893953|NCT03697096|Other|INSPIRE CPOE Smart Prompt|"Quality improvement intervention: computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimate of having a UTI due to a multidrug resistant organism (MDRO) and recommends appropriate antibiotic choice for non-ICU patients in the first 3 days of hospitalization.
~Continuation of other antibiotic stewardship activities in accordance with national standards."
15893954|NCT03697083|Other|Reminders Through Association|Participants receive 8 text messages asking them to think of a reminder cue that will help them remember to pick up the prescription and use the cue.
15893955|NCT03697083|Other|Active Control|Participants receive 8 text messages asking them to think of where they plan to store their medication once they pick it up and to think about that location on their intended date of pickup.
15893956|NCT03697083|Other|Baseline Control|Participants receive 1 text message thanking participants for enrolling in the reminder program. Participants are not contacted further.
15893957|NCT03697070|Other|INSPIRE CPOE Smart Prompt|"Quality improvement intervention: computerized physician order entry (CPOE) decision support alert that provides physicians with patient-specific risk estimate of having PNA due to a multidrug resistant organism (MDRO) and recommends appropriate antibiotic choice for non-ICU patients in the first 3 days of hospitalization.
~Continuation of other antibiotic stewardship activities in accordance with national standards."
15893958|NCT03697070|Other|Routine Care|Routine Antibiotic Stewardship Arm - Continuation of all antibiotic stewardship activities in accordance with national standards.
15893959|NCT03697057|Procedure|General anaesthesia|Standard general anaesthesia for gynecologic surgery in patient group
15893960|NCT03697044|Procedure|Irinotecan Drug-Eluting-Bead Trans Arterial ChemoEmbolisation|Patient Registry to assess the delivery of Irinotecan loaded drug eluting beads for the treatment of colorectal liver cancer metastases.
15893962|NCT03697018|Other|zirconia reinforced lithium silicate glass ceramic|It represent a new generation of glass ceramic material. Using an innovative manufacturing process the glass ceramic is enriched with zirconia (10% by weight) for dental CAD/CAM applications for the fabrication of inlays, onlays, crowns and anterior and posterior single tooth restorations on implant abutments.
15893963|NCT03697005|Other|BioHPP PEEK single posterior crowns|BioHPP is a 20% ceramic reinforced, semicrystalline, thermoplastic and radiolucent polymeric material, used for fabrication of high strength fixed and removable prostheses. it has advantages of bio-compatibility, low density, light weight, shock absorption.
15893964|NCT03697005|Other|zirconia-based single posterior crowns|ZrO2, a ceramic material used for medical devices, displays good esthetic appearance, high mechanical strength, and high biocompatibility and is used in a wide range of indications, such as frameworks, implants, and abutments. In addition, it's very good long-term stability and reliability was proven in a 10-year clinical study. These excellent material properties and the transformation behavior are explained by the yttrium oxide stabilization of ZrO2.
15893965|NCT03696992|Procedure|Tandem colonoscopy|Tandem colonoscopy with different image modalities
15893966|NCT03696979|Other|Myofascial induction therapy|Myofascial induction therapy is a therapy concept focused on optimizing function and balance within the fascial system. The approach aims at global recovery, local correction and painless body use.
15894002|NCT03696719|Device|BIS bispectral index monitoring device|In addition to the standard monitoring prescribed by the American society of Anesthesiologists, all study participants will be monitored with the BIS, a noninvasive monitoring device which measures the depth of anesthesia. The monitoring is performed using noninvasive electrodes placed on the forehead.
15894038|NCT03696459|Drug|JNJ-53718678 Placebo|Participants will be administered JNJ-53718678 matching placebo in Part 1 and 2.
15911420|NCT03563144|Biological|ETBX-061|Ad5 [E1-, E2b-]-mucin 1[MUC1]
15893967|NCT03696979|Other|Therapeutic pain education|Therapeutic pain education is a training intervention that aims to reduce pain and disability by helping patients better understand the biological processes that support pain states. The neurobiology of pain and pain processed by the nervous system is explained to the patient in detail. Changes the patient's olab viewpoint to pain. For example, the patient believes that the cause of pain is caused by tissue damage. The patient who receives pain training understands that the cause of pain is the hypersensitive central nervous system. As a result, the patient's fear avoidance behavior decreases and he starts to move more easily. Because the sensitivity of the central nervous system will be alleviated, the perceived pain will decrease.
15893968|NCT03696966|Dietary Supplement|Portion-Controlled Meals|Increase dietary structure using portion-controlled meals (PCM)
15893969|NCT03696966|Behavioral|Low-Calorie Diet|Restrict calorie intake daily
15893970|NCT03696966|Behavioral|Intermittent Very-Low Calorie Diet|Severely restrict calorie intake intermittently
15893971|NCT03696953|Biological|Florajen3|Probiotic combination product One capsule daily by mouth.
15893972|NCT03696940|Drug|L-Carnitine 500Mg Oral Tablet + Atorvastatin 10 mg|Oral administration of 2 tablets of atorvastatin 10 mg (each one) every 24 hours for 6 months.
15893973|NCT03696940|Drug|Atorvastatin 10mg|Oral administration of 2 tablets atorvastatin 10 mg (each one) every 24 hours for 6 months.
15893974|NCT03696927|Device|Active Powered Prosthesis (APEX) for Spinal Cord Injury|The Active Powered Prosthesis (APEX) is a proof-of-concept shoulder-elbow-wrist device intended to provide non-invasive active powered robotic assistive movement to upper extremities. Focus group participants will control the APEX device on a test manikin and provide feedback on the device design and function.
15893975|NCT03696901|Drug|Xydalba|Information will be recorded about Xydalba administration (e.g. dose(s), number of infusions, length of infusions, dates or schedule of administration, sites of administration [e.g. hospital, ICU]), and reason for discontinuation, including response to treatment to assess whether the patient was clinically improving when Xydalba was discontinued
15893976|NCT03696888|Behavioral|Telecoach|A skills-training web-app teaching skills for reducing problematic alcohol use.
15893977|NCT03696888|Behavioral|TeleCoach control|A web-app providing information about the health-related consequences of alcohol consumption.
15893978|NCT03696875|Other|Multilevel Guided Discharge Planning|Clinical recommendations and resources activations + scheduling of early visit with the specialist + communication with primary care + written instruction sheet to the patient
15893979|NCT03696875|Other|Standard of care|Standard of care
15893980|NCT03696862|Procedure|free gingival graft|Use of free gingival graft to seal the socket after flapless atraumatic tooth extraction is performed, implant placement and filling the socket with bone graft.
15893981|NCT03696849|Other|polished emax Press|lithium disilicate glass ceramic crowns subjected to polishing only
15893982|NCT03696836|Device|Trammpolin® meniscus prosthesis|Trammpolin® meniscus prosthesis is an anatomically shaped, synthetic medial meniscus replacement
15893983|NCT03696823|Procedure|laparoscopic cholecystectomy|treatment of chronic calcular cholecystitis laparoscopically
15893984|NCT03696810|Diagnostic Test|Laboratory tests|• Laboratory tests (HbA1C levels and lipids)
15893987|NCT03696784|Biological|iC9-CAR19 T cells|iC9-CAR19 T cells will be given by a licensed healthcare provider via intravenous injection over 5-10 minutes through either a peripheral or a central line.
15893988|NCT03696784|Drug|Bendamustine|70mg/m2 IV given as a daily infusion for 3 days per institutional guidelines 2 - 14 days prior to the T cell infusion.
15893989|NCT03696784|Drug|Fludarabine|30 mg/m2 given as a daily infusion for 3 days per institutional guidelines 2 - 14 days prior to the T cell infusion
15893990|NCT03696784|Drug|AP1903|0.4 mg/kg of AP1903 as an IV infusion over 2 hrs for subjects who develop Grade 4 CRS or grade ≥3 CRS that is unresponsive to standard of care interventions (i.e., does not resolve to grade 0 - 1 within 24 hours after 2 doses of tocilizumab, with sum of doses ≥12mg/kg), subjects who develop grade ≥3 ICANS that does not improve to grade ≤1 within 72 hours with standard of care interventions, and subjects with grade 4 ICANS of any duration that have evidence of cerebral edema and/or generalized convulsive status epilepticus.
15893991|NCT03696784|Drug|Cyclophosphamide|500 mg/m2/day administered by IV over 3 consecutive days
15893992|NCT03696771|Drug|NJH395|Immune stimulator antibody conjugate (ISAC), consisting of a monoclonal antibody which targets HER2 conjugated to an immune-stimulatory agent
15893993|NCT03696758|Procedure|Pulmonary Function Testing|Subjects will undergo spirometry, Plethysmography, and diffusion capacity.
15893994|NCT03696758|Procedure|Electrocardiogram|Subjects will undergo an electrocardiogram to ensure sinus rhythm
15893995|NCT03696758|Procedure|Cardiac Magnetic Resonance Imaging|Subjects will undergo positron magnetic resonance imaging to detect images of the heart
15893996|NCT03696758|Drug|Metoprolol|Subjects will receive intravenous metoprolol. Dose titrated 1-5 mg every 2 minutes to achieve goal heart rate of 55-65 beats per minute, or for subjects with a resting heart rate already at goal, titrated to achieve a 10-15% reduction in heart rate.
15893997|NCT03696758|Drug|Sildenafil|Subjects will receive a 50 milligram tablet of sildenafil (to be taken orally)
15893998|NCT03696745|Other|autologous umbilical cord blood stem cells|autologous umbilical cord blood stem cells treatment for brain injury for safety and effect evaluation
15893999|NCT03696745|Drug|0.9% Sodium-chloride|0.9% Sodium-chloride in control group
15894000|NCT03696732|Other|Anxiety questionnaire|Spielberger. State-Trait Inventory questionnaire
15894001|NCT03696732|Other|VAS questionnaire|verbal numerical scale (VNS) anxiety score
15894003|NCT03696719|Biological|NSE cerebral biomarker testing|Venous blood will be collected from each participant in the surgery room prior to anesthesia induction, throughout anesthesia and one hour following surgery in the PACU in order to assess NSE cerebral biomarker according to the ELISA method requirements. At each one of the assessment points 9 cc of venous of blood will be taken from each of the study participants, while routine blood tests are taken.
15894004|NCT03696706|Radiation|LED photobiomodulation|LED photobiomodulation will be applied at 36 points, bilaterally, in the temporomandibular joint regions, around these joints, and in the regions of the masseter muscles and anterior part of the temporal muscles, three times a week, totaling 6 treatment sessions, in 2 weeks. The LED apparatus is composed of a flexible rectangular plate (10cm/12cm), which adapts to the format of the area to be treated containing 18 red LEDs - 660 nm and 18 infrared LEDs - 850 nm, with a power of 3.5 mW by LED, 4.45 mW/cm2, radiant exposure of 5.35 J/cm2, radiated area of 14.13 cm2, and energy of 75.6 J.
15894005|NCT03696706|Radiation|Placebo LED photobiomodulation|In this group, the same procedures as the LED group will be made, but the device will be turned off.
15894006|NCT03696693|Device|acoustic vocal analysis|Computerized Speech Laboratory (model 4300; Kay Elemetrics Corporation)
15894007|NCT03696680|Radiation|FSRT Stereotactic radiation therapy|For each metastasis, dose of 30 Gy in 3 fractions at 10 Gy / fraction over 7 days
15894008|NCT03696667|Device|BCI|As participants listen to the music, the EEG waves of their affective states and their variations detected in real-time is converted into an auditory signal providing direct feedback to participants about their affective states and assisting participants to learn and practice emotion regulation.
15894009|NCT03696654|Procedure|adenotonsillar surgery|when indicated, adenotonsillar surgery for SDB treatment
15894010|NCT03696641|Other|glazed lithium disilicate crowns|glazing of IPS e.max crowns
15894011|NCT03696641|Other|polished lithium disilicate crowns|polishing of IPS e.max crowns
15894012|NCT03696628|Other|Electrocardiogram|heart testing
15894013|NCT03696628|Other|physical examination|done by the investigator
15894014|NCT03696628|Other|echocardiography|heart testing
15894015|NCT03696628|Biological|blood test|A sample of blood will be taken to each patient or healthy children in order to generate hiPSC-cardiomyocytes
15894016|NCT03696615|Other|Tabata Kettlebell Swing Workout|See description of experimental arm.
15894017|NCT03696615|Other|Control|see description of control arm
15894018|NCT03696602|Diagnostic Test|bronchial provocation test|
15894019|NCT03696589|Behavioral|Physical Activity Coaching|Based in the self-determination theory, participants will be coached on beneficial exercises, how to utilize supports and overcome barriers to PA engagement. Emphasis of exercise coaching will be on increasing aerobic exercise engagement and will include us of Fitbit devices to facilitate uptake and monitor aerobic exercise. Intervention will be delivered by a physical or occupational therapist, who will work with the participant to develop a plan, set goals and targets, and track changes. Additional resources that will support exercise engagement will be provided. Participants will have the choice to receive their face-to-face session either in person or remotely via secure video-based service.
15894020|NCT03696576|Device|EMST|Training of the respiratory system muscles using the EMST device.
15894021|NCT03696576|Behavioral|PhoRTE|Completing of PhoRTE voice therapy.
15894022|NCT03696563|Device|Automated oxygen administration - FreeO2|The adjustment of the oxygen flow will be made by the FreeO2 system, an automated titration of oxygen flow every second to reach the SpO2 target. The SpO2 target will be set at 90% in COPD patients and 94% in trauma patients.
15894023|NCT03696563|Other|Standard administration of oxygen flow|The flow of oxygen will be administered according to the usual protocol during the transport and until transfer to the emergency departement.
15894024|NCT03696550|Drug|Eravacycline (TP-434)|"Subjects will be stratified by age into 2 cohorts, as follows:
~Cohort 1: from 12 to <18 years of age (N=8)
~Cohort 2: from 8 to <12 years of age (N=12 or at least 60% of subjects)"
15894025|NCT03696537|Drug|Fludarabine|Fludarabine 30 mg/m2/day IV (total 5 doses) administered days -7 through -3 of conditioning regimen
15894026|NCT03696537|Radiation|Total Marrow Irradiation (TMI)|TMI will be delivered twice a day, at least 6 hours apart, on days -7 through -3 (total of 10 fractions) of conditioning regimen
15894027|NCT03696524|Device|tunneled pleural catheter|Placement of a tunneled pleural catheter through the chest wall into the pleural space to drain the patient's chronic pleural effusion. The catheter is an indwelling device that will be drained from home three times per week by nursing care, the patient, or patient's family.
15894028|NCT03696511|Device|Orthodontic miniscrew insertion|orthodontic treatment using miniscrews as anchorage reinforcement
15894029|NCT03696498|Procedure|Resin restoration (1 step)|Permanent resin restoration is placed on top of the partial removed caries.
15894030|NCT03696498|Procedure|Resin restoration (2 steps)|A calcium hydroxide containing base material is used and a temporary glass-ionomer restoration is placed in the entire cavity. After 4-6 months the patients are recalled. The temporary restoration is removed and final excavation is carried out with hand excavators until firm but stained dentine remains. A permanent resin restoration is performed.
15894031|NCT03696485|Biological|SCM-010|SCM-010 is comprised of adipose derived expanded mesenchymal cells (ADSC), suspended in Plasma-Lyte and intended for intrathecal (IT) administration.
15894032|NCT03696472|Procedure|robotic assisted surgery|robotic assisted surgery was benefit to operation
15894033|NCT03696472|Procedure|laparoscopic|conventional laparoscopic surgery
15894034|NCT03696459|Drug|JNJ-53718678, 2000 mg|Participants will be administered JNJ-53718678, 2000 mg as oral suspension in Part 1 (Panel 1).
15894035|NCT03696459|Drug|JNJ-53718678, 3000 mg|Participants will be administered JNJ- 53718678, 3000 mg as oral suspension in Part 1 (Panel 2).
15894036|NCT03696459|Drug|JNJ-53718678, 4500 mg or Dose to be decided|Participants will be administered JNJ-53718678, 4500 mg as oral suspension in Part 1 (Panel 3). If this dose is considered safe and tolerable and if pharmacokinetic data require further dose escalation, then participants will receive JNJ-53718678 (Dose to be decided) in Part 1 (Panel 4). This dose (either from Panel 3 or Panel 4 ) will be used in Part 2 (Dose may be lower/higher based on review of safety, tolerability, and PK data obtained in Part 1).
15894037|NCT03696459|Drug|JNJ-53718678 500 mg|Participants will be administered JNJ-53718678, 500 mg as oral suspension in Part 2.
15894039|NCT03696459|Drug|Moxifloxacin 400 mg|Participants will be administered moxifloxacin 400 mg as capsule in Part 2.
15894040|NCT03696459|Drug|Moxifloxacin Placebo|Participants will be administered moxifloxacin matching placebo in Part 2.
15894041|NCT03696446|Behavioral|Virtual Cardiac Rehabilitation Program|This group will receive their Rehab program primarily online through a secure web-based platform with a trained facilitator.
15894042|NCT03696446|Behavioral|Case Managed Home Program|This group will receive their Rehab program over the phone with a trained facilitator
15894043|NCT03696433|Dietary Supplement|Low-salt diet|The low-salt diet (7 days) will consist of meals, snacks and water provided by Vanderbilt's metabolic kitchen.
15894044|NCT03696433|Dietary Supplement|High-salt diet|The high-salt diet (7 days) consists of each subject's typical diet, supplemented each day with 2 bullion broth packets, which will be provided to the subject by the study staff.
15894045|NCT03696420|Other|Coordinates of active plots and VIM landmarks calculation|Stimulation efficacy will be assessed by comparing, according to usual care, the clinical evaluation (FTM scale) with and without stimulation, and the four contacts of each electrode will be tested clinically, with an accelerometer and an electromyography to determine which one is the most active on tremor. Coordinates of the anatomical landmarks will be calculated on the pre-operative MRI and those of the active plots on the fusion between post-operative CT-scan and pre-operative MRI.
15894046|NCT03696394|Device|BioCartilage® Micronized Cartilage Matrix|BioCartilage® is a scaffold with Collagen Type II and cartilage matrix elements
15894047|NCT03696381|Other|Real tRNS|The treatment consists of a set of 1-h sessions, three sessions per week for 8 weeks. A series of cognitive exercises of attention, memory, and executive functions will be conducted in each session. During the first 20 minutes of each cognitive training session, patients will receive bi-frontal and bi-parietal tRNS. It has a start and end ramp of two seconds in each case to avoid the slight unpleasant sensation that occurs in the first moments of the introduction of direct current DC.
15894048|NCT03696381|Other|Sham tRNS|The treatment consists of a set of 1-h sessions, three sessions per week for 8 weeks. A series of cognitive exercises of attention, memory, and executive functions will be conducted in each session. We will apply a sham tRNS for the first 20 minutes of each cognitive training session. The subjects will receive sham tRNS and will perform the same type of cognitive training as the rest of patients and will receive the same type of adverse reaction questionnaire. Subjects receiving simulated stimulation will receive the same type of ramps at the beginning and end of the session to ensure triple-blind maintenance .
15894049|NCT03696355|Drug|GDC-0084|Given PO
15894050|NCT03696355|Radiation|radiation therapy|Both photon and proton therapy modalities will be allowed.
15894051|NCT03696342|Drug|Pazufloxacin|"Pazufloxacin 0.6%. by Sophia Laboratories, topical ophthalmic
~1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days."
15894052|NCT03696342|Drug|Zymar|"Gatifloxacin 0.3%. by Allergan, topical ophthalmic
~1 drop, 3 times a day during the waking period in both eyes (at approximate intervals of 6 hours), for 7 days."
15894053|NCT03696329|Drug|Tetrabenazine Tablets 25 mg|
15894054|NCT03696303|Other|Urinary antigen detection assay|Screening for Ag level in S. pneumoniae urinary antigen detection assay.
15894055|NCT03696290|Drug|Aztreonam lysine|Nebulised aztreonam lysine 75mg
15894056|NCT03696290|Other|Placebo|Nebulised lactose monohydrate 5mg
15894057|NCT03696277|Radiation|Stereotactic ablative body radiation (SABR)|SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
15894058|NCT03696264|Dietary Supplement|Amino acid intake|Amino acid intake will range between 0.2-3.0g/kg/d
15894059|NCT03696238|Dietary Supplement|500mg of Aronox® >40% polyphenol aronia extract|Name: Aronia PE 40% polyphenols Description: Powdered extract obtained from aronia berries (Aronia melanocarpa) Dosage form: Capsule (opaque, beige, size 00) Strength: 500 mg aronia extract Regimen 1 capsule, once a day with breakfast (except on days when attending the laboratory) Batch number: As per label Expiry Date: As per label Manufacturer: NATUREX / Virage sante
15894060|NCT03696238|Other|Placebo|Name: Placebo Description: Identical formulation as the treatment consisting of colored maltodextrin using artificial colors Dosage form: Capsule (opaque, beige, size 00) Strength: 500 mg placebo Regimen 1 capsule, once a day with breakfast (except on days when attending the laboratory) Batch number: As per label Expiry Date: As per label Manufacturer: NATUREX (Advance nutraceutical) / Virage sante
15894061|NCT03696225|Behavioral|Compensatory Cognitive Training (CCT)|Compensatory Cognitive Training draws from the theoretical literature on compensatory strategy training for other cognitively impaired populations (e.g., Huckans et al., 2013; Twamley et al., 2010; Storzbach et al., 2016). It is a rehabilitation model that aims to teach individuals strategies that allow them to work around cognitive deficits. Consistent with this model and the expert recommendations for civilians and Service members with TBI (Cicerone, 2011), manualized CCT treatment provides training in compensatory attention and learning/memory skills, formal problem-solving strategies applied to daily problems, and the use of external aids such as calendar systems and assistive devices to promote completion of daily tasks (Storzbach et al., 2016).
15894062|NCT03696225|Behavioral|Treatment as Usual (TAU)|All TAU participants have an ongoing VA mental health provider and received ongoing mental health care during the course of the study (generally weekly individual or group sessions focusing on evidence-based PTSD treatment).
15894063|NCT03696212|Drug|grapiprant and pembrolizumab|Participants will be administered 21-day cycles of oral grapiprant in combination with IV pembrolizumab
15894064|NCT03696199|Drug|Long-Acting Local Anesthesia|"The cocktail consists of:
~0.5% Ropivicaine, 24.6 mL
~Clonidine 100 mcg/mL, 0.4mL
~Epinephrine 1mg/mL, 0.5mL
~Saline to total volume of 50 mL (24.5mL of saline)
~The total amount of solution prepared is 50mL, but typically 30mL is used based on the size of the incision. The total volume administered will be recorded."
15894065|NCT03696199|Drug|Regional Anesthesia|0.5% ropivicaine - 30mL each sciatic and femoral/saphenous nerve, ultrasound guided
15894066|NCT03696186|Drug|Luminal type-1|Goserelin (3.75mg, once every 4 weeks)+Docetaxel (75 mg/m2 on day 1 every 3 weeks)+Prednisone (5 mg, twice daily)
15894067|NCT03696186|Drug|Luminal type-2|Goserelin (3.75mg, once every 4 weeks)+Abiraterone (1000 mg, once daily)+Prednisone (5 mg, twice daily)
15894068|NCT03696186|Drug|Neuroendocrine type-1|Goserelin (3.75mg, once every 4 weeks)+Docetaxel (75 mg/m2 on day 1 every 3 weeks)+Prednisone (5 mg, twice daily)
15894069|NCT03696186|Drug|Neuroendocrine type-2|Goserelin (3.75mg, once every 4 weeks)+Carboplatin (area under the curve 5 on day 1 every 3 weeks)+Docetaxel (75 mg/m2 on day 1 every 3 weeks)+Prednisone (5 mg, twice daily)
15894070|NCT03696186|Drug|Atypical type-1|Goserelin (3.75mg, once every 4 weeks)+Docetaxel (75 mg/m2 on day 1 every 3 weeks)+Prednisone (5 mg, twice daily)
15894071|NCT03696186|Drug|Atypical type-2|Goserelin (3.75mg, once every 4 weeks)+Abiraterone (1000 mg, once daily)+ targeted therapy according to next Generation Sequencing (NGS)+ Prednisone (5 mg, twice daily), or Goserelin (3.75mg, once every 4 weeks)+Abiraterone+ Prednisone (5 mg, twice daily) if no druggable gene mutation detected.
15894072|NCT03696173|Other|Non-Interventional|Non-Interventional
15894073|NCT03696173|Other|Non-Interventional|Non-Interventional
15894074|NCT03696160|Drug|Biktarvy|Integrase inhibitor used to treat HIV-1 infection
15894075|NCT03696160|Drug|Symtuza|Protease inhibitor used to treat HIV-1 infection
15894076|NCT03696147|Device|Magnetic resonance imaging|Diffusion weighted sequence of MRI
15894077|NCT03696134|Other|questionnaire|questionnaire
15894078|NCT03696121|Drug|Desmopressin Injection|Single dose 20 micrograms in 50ml Normal Saline as intravenous injection infused over 20 minutes
15894079|NCT03696121|Drug|Normal saline|Single dose 50ml Normal Saline as intravenous injection infused over 20 minutes
15894080|NCT03696108|Drug|Gefapixant|Participants will receive a gefapixant 15 mg or 45 mg tablet administered orally BID
15894081|NCT03696095|Drug|Ropivacaine Hcl 0.2% Inj Bag 200Ml (PIB mode)|programmed intermittent bolus 5ml each one hour.
15894082|NCT03696095|Drug|Ropivacaine Hcl 0.2% Inj Bag 200Ml (CI mode)|continuous infusion 6ml/h
15894083|NCT03696082|Behavioral|Aerobic Activity|Moderate-intensity exercise aerobic exercise that involves participating in activities similar to brisk walking that increase heart rate and breathing rate, with activity progressing to 150 minutes per week. Activities other than brisk walking, such as dance, aerobics, swimming, cycling or other activities that increase heart rate and breathing rate to a moderate intensity that can be sustained for at least 10 minutes will also be encouraged. This will require the participant to attend one supervised session each week for a period of 12 months with the remaining sessions being performed on their own without supervision.
15894084|NCT03696082|Behavioral|Resistance Training|Resistance exercise that involves participating in activities similar to lifting weights that cause the participant to work specific muscles of your body, with activity progressing to 150 minutes per week. This can involve using weight training machines, elastic tubes that create resistance, or weights such a dumbbells. This will require the participant to attend one supervised session each week for a period of 12 months with the remaining sessions being performed on their own without supervision.
15894085|NCT03696082|Behavioral|Yoga|Yoga involves a series of movements and poses that are performed in a specific sequence that are adapted to your ability, with activity progressing to 150 minutes per week. This will require the participant to attend one supervised session each week for a period of 12 months with the remaining sessions being performed on their own without supervision.
15894086|NCT03696082|Behavioral|Health Education|This involves the participant receiving information regarding aspects of health that are important for older adults, and also physical activity in the form of light stretching activities and movements. This will require the participant to attend one supervised session each week for a period of 12 months with the remaining sessions being performed on their own without supervision.
15894087|NCT03696069|Other|Non-Interventional|Non-Interventional
15894088|NCT03696056|Behavioral|Kirtan Kriya meditation|The program incorporates song with visualization and mudras, and is a multi-faceted, multisensory exercise that appears to engage several areas of the brain implicated in cognitive decline, yet is simple to learn and practice. The meditation includes a repeated Kirtan or song, a mudra or physical/motor component, and a visualization component. The meditation sound file will contain a user friendly introduction to the Kirtan Kriya meditation technique along with detailed instructions and meditation tracks. Three tracks will contain 12 minute guided meditations with the same female voice, and 2 with nature sounds, 2 without any additional sounds. Another 2 tracks will provide only the timing cues (1 with nature sounds, 1 without) so that the participant can conduct the meditation session without guidance if they chose.
15894089|NCT03696056|Behavioral|Music listening program|"The participants will receive audio files and an instruction sheet to facilitate their practice.
~The audio tracks are 12 minutes in length and contain relaxing instrumental music from Mozart, Bach, Beethoven, Debussy, and Pachebel. Participants are instructed to sit comfortably with their eyes closed and listen to a track of their choice for 12 min daily, for 8 weeks and to record each session on their practice log."
15894090|NCT03696043|Other|Axium Steatlh Image Guidance|The Axiem Stealth imaging guidance system uses a probe (AxiEM Registration Probe) and a side mount emitter (AxiEM Side Mount Emitter) to register the patient's head in relation to the probe. A trajectory (entry point and target) is then planned. This registration process takes an estimated 5-15 minutes to perform. A separate stylet (StealthStation EM Stylet) is designed specifically for the catheter and slides down the center of the catheter. A burr-hole is created at the predefined precise location and the catheter is passed to the target under electromagnetic guidance.
15894091|NCT03696043|Other|EVD placement|A sterile field is prepared about 10-12 centimeters posterior to the eye and about 2-3 cm lateral to the midline of the skull. An incision is made at this point and a burr hole is created using a hand drill. The catheter is advanced in a trajectory perpendicular to the skull, which results in a direction that is towards the ipsilateral medial canthus and ipsilateral tragus which are other landmarks that can be used.
15894092|NCT03696030|Biological|Chimeric Antigen Receptor T-Cell Therapy|Given HER2-CAR T cells via intraventricular administration
15894093|NCT03696004|Drug|FEC-100|Patients will recieve six cycles of FEC-100 and Breast conservative surgery after 4-6 weeks
15894094|NCT03695991|Procedure|percutaneous nephrostomy|The percutaneous nephrostomy will be done under sonographic or fluoroscopic guidance. Establishment of intravenous access and antibiotics will be performed half an hour prior to procedure particularly in patients presenting with urinary tract infection. The procedure will be done under local anesthesia but general anesthesia may be used for uncooperative patients. percutaneous nephrostomy will be performed in the prone position, however, in case of relative contraindication to prone position
15894551|NCT03692286|Drug|Calcium Hydroxide Intracanal medication|Calcium hydroxide intracanal medication
15894095|NCT03695965|Procedure|magnetic resonance imaging.|1.5 Tesla magnet system is going to be utilized for ankle imaging. A dedicated extremity surface coil (Foot/Ankle 16-Channel Coil; Siemens Medical Solution) is used to enhance spatial resolution.
15894096|NCT03695952|Drug|Nivolumab or pembrolizumab|Nivolumab 3 mg/kg intravenous every 2 weeks; Pembrolizumab 200 mg intravenous every 3 weeks
15894098|NCT03695926|Drug|[18F]MNI-1054|Healthy volunteers recruited for the study will undergo a [18F]MNI-1054 PET scan.
15894099|NCT03695913|Other|Normal Diet|"Phase I (regular diet):
~all participants will eat their normal diet and will log their food."
15894100|NCT03695913|Other|Low carb diet|"Phase II (low carb diet):
~participants will be asked to eat a low carb diet and log their food"
15894101|NCT03695913|Device|CGM with no real time feedback|Phase I will collect CGM without real time feedback
15894102|NCT03695913|Device|CGM with real time feedback)|Phase II participants will be asked to scan their sensor at least every eight hours and document their blood sugar before and two hours after eating as well as before breakfast and before going to bed.
15894103|NCT03695913|Behavioral|Education material|"Phase I: participants will be given the book Always Hungry and be asked to read chapters 1-5 after a health check phone call approximately 5 days after the sensor is placed.
~Phase II: participants will be taught about carbohydrates and the benefits and side effects. Additionally, they will be given multiple resources to assist them regarding carbohydrates as well as a book entitled The Calorie King, Calories, Fat, and Carbohydrates. Groceries will also be delivered for 2 recipes that the participants choose from to make."
15894104|NCT03695900|Other|Targeting SpO2 at 93-95%|FiO2 adjusted to keep basal SpO2 at target range of 93-95% for 2 hours
15894105|NCT03695900|Other|Targeting SpO2 at 90-92%|FiO2 adjusted to keep basal SpO2 at target range of 90-92% for 2 hours.
15894106|NCT03695887|Drug|Nitrous Oxide Inhalant Product|Nitrous Oxide Inhalant Product
15894107|NCT03695887|Drug|Placebo|Inactive comparator
15894108|NCT03695874|Other|Phase 1 : fill out 1 scale|"Patients will be asked to complete questionnaires.
~Group 1: the purpose is to simplify a 75 items scale by a statistical analysis of the data collected from 400 patients. The statistical purification will allow to finalize an abbreviated scale (20-25 items).
~Doctors specialized in Hereditary Haemorrhagic Telangiectasia may suggest that patients enter the study. After submission of the information notice and collection of their non-opposition, patients will have the choice to fill out the paper version or the electronic version of the scale and questionnaires."
15894109|NCT03695874|Other|Phase 2 : fill out 1 scale and 4 questionnaires|"Patients will be asked to complete questionnaires.
~Group 2: the purpose is to validate the abbreviated scale by a statistical analysis of the data collected from 200 patients. The statistical validation will allow to check the consistency and correlation of the abbreviated scale with other scales: a general Quality Of Life scale (SF36), an anxiety and depression scale (HAD), a social support scale (SSQ6) and a scale of regulation emotional (CERQ) and to test and re-test to check fidelity of the abbreviated scale.
~Doctors specialized in Hereditary Haemorrhagic Telangiectasia may suggest that patients enter the study. After submission of the information notice and collection of their non-opposition, patients will have the choice to fill out the paper version or the electronic version of the scale and questionnaires."
15894110|NCT03695861|Diagnostic Test|Whole-body 18F-FDG PET-CT scan|A 18F-FDG PET-CT will be performed within 5 days of the beginning of the patients care with infectious endocarditis at the University Hospital center of Bordeaux.
15894111|NCT03695848|Device|MRI scan|Before decompresssion surgery, DTI and fMRI will be recorded by a FDA approved 3T MRI scanner (Philips Achieva)
15894112|NCT03695835|Drug|Immunotherapeutic Agents|Antigen exposure immediately followed by in situ injection of combination of immunotherapeutic agents
15894113|NCT03695835|Device|Ablation|Antigen exposure immediately followed by in situ injection of combination of immunotherapeutic agents
15894114|NCT03695822|Drug|Mirabegron 25mg|The aim of this study is to elucidate the impact of mirabegron on psychological distress, bladder blood flow and c reactive protein.
15894115|NCT03695809|Biological|G9a protein|To assess G9a protein expression on vulvar cancer
15894116|NCT03695796|Diagnostic Test|biopsy-proven NAFLD patients with non-invasive tests of liver fibrosis (blood tests, elastography devices) and biobank|To evaluate and improve the non-invasive diagnosis of liver fibrosis in NAFLD and to develop the non-invasive diagnosis of NASH
15894117|NCT03695783|Other|Online decision aid called IBD&me|Patients randomized to IBD&me will be directed to go through the website at least 2 days before their clinic appointment, and will be asked to bring their personalized report with them to their upcoming visit.
15894118|NCT03695783|Other|Standardized educational material|Patients randomized to the control arm will be sent a PDF file corresponding to the CCFA's online resource at least 2 days before their clinic appointment, and will be asked to bring it with them to their upcoming visit.
15894119|NCT03695770|Other|kit for self-diagnosis and self-treatment|distribution of kits for malaria self-diagnosis and self-treatment after a training by health facilitators
15894120|NCT03695757|Biological|Part A) Healthy subjects|Part A) Autologous total IgG 50mg will be administered to the healthy subjects by intramuscular injections, twice a week for 4 weeks (total 8 injections).
15894121|NCT03695757|Biological|Part B) Advanced solid tumor|Part B) Autologous total IgG 50mg will be administered to the patients with advanced solid tumor by intramuscular injection, twice a week for 4 weeks (total 8 injections).
15894122|NCT03695744|Drug|Daratumumab|Daratumumab
15894123|NCT03695744|Drug|Bortezomib|Bortezomib
15894124|NCT03695744|Drug|Dexamethasone|Dexamethasone
15894125|NCT03695731|Procedure|cold induced activation of brown adipose tissue|cold exposure wearing a cold life jacket
15894126|NCT03695705|Drug|Rifaximin 550 mg twice a day and Norfloxacin 400 mg once a day|Patients on Rifaximin prophylaxis will be given 550 mg twice daily and on Norfloxacin prophylaxis will receive Norfloxacin 400 mg once daily for 6 months
15894127|NCT03695692|Behavioral|pelvic floor exercise and connective tissue massage|Pelvic floor exercises with connective tissue massage will be performed.The massage program is carried out for 18 sessions, 3 days/week in 6 weeks. The exercise program is performed every day for 6 weeks
15894128|NCT03695692|Behavioral|pelvic floor exercise|The exercise program is performed every day for 6 weeks
15911422|NCT03563144|Biological|GI-6207|CEA yeast vaccine
15894129|NCT03695679|Behavioral|Interactive computer-based intervention|"There are 4 components of the Interactive computer-based intervention(ICBI) which will be delivered in 3 phases:
~Perceived Susceptibility and Perceived Severity
~Perceived Benefits and Perceived Barriers
~Cue to Action
~Self-Efficacy
~In addition, a discussion forum will be created to handle questions from the participants. Also, there will be an email address for enquiries if the participants need any support or if they want to seek further enquiry/ clarification after reading the web-based information."
15894130|NCT03695666|Other|Clerical policy|Clerical policy introduction
15894131|NCT03695653|Behavioral|Drink Tracking (MA)|Weekly drink tracking for self-monitoring and assessment
15894132|NCT03695653|Behavioral|Adaptive Tailored (TA)|Messages are sent more frequently and tailored to some baseline characteristics and adapt to progress
15894133|NCT03695653|Behavioral|Tailored (TO)|Messages are sent more frequently and tailored to some baseline characteristics
15894134|NCT03695640|Drug|Magnesium Sulfate|Addition of magnesium sulfate as an adjuvant to levobupivacaine
15894135|NCT03695640|Procedure|continuous femoral nerve block|continuous nerve block with levobupivacaine for treatment postoperative pain
15894136|NCT03695627|Behavioral|Meditation|10 minute a day, 8 week digital meditation
15894137|NCT03695614|Other|Cognitive Remediation Therapy|Cognitive Remediation is a well-established psychotherapy that aims to improve neurocognitive abilities such as memory performance, executive functioning, processing speed, and attention.
15894138|NCT03695601|Other|Standard of Care|Other Standard measures for monitoring rejection: Endomyocardial Biopsy, Echocardiogram, Angiography, Intravascular Ultrasound, Donor-specific HLA Antibody
15894139|NCT03695588|Procedure|Quadratus lumborum block|Ultrasound guided Quadratus Lumborum block using a posterior approach. (QLB 2)
15894140|NCT03695588|Procedure|Sham QLB|Sham QLB - Ultrasound identification of QLB followed by skin pressure with blunt needle.
15894141|NCT03695575|Device|Bone-conduction headset|A bone-conduction headset paired with a microphone will be used.
15894142|NCT03695562|Procedure|sequential drilling technique|Patient with vitamin D deficiency using sequential drilling technique
15894143|NCT03695549|Procedure|CAF + (A-PRF)|advanced platelet rich fibrin prepared by low speed centrfugation concept(LSCC) together with coronally advanced flap .
15894144|NCT03695549|Procedure|CAF+SCTG|cornally advanced flap plus subepithilial connective tissue graft harvested from the palate
15894145|NCT03695536|Behavioral|ultrasound use during resuscitation|ultrasound use during resuscitation
15894146|NCT03695523|Behavioral|PLAY (PhysicaL ActivitY) Policy Intervention|An evidence-based physical activity policy that was developed by researchers and childcare stakeholders and directed by the Canadian 24-Hour Movement Guidelines for the Early Years will be adopted by experimental group childcare centres for 8 weeks. The policy incorporates 8 items (i.e., encouraging children to engage in higher intensity energetic play often, aiming to accumulate 40 minutes each day, exposing children to a variety of indoor and outdoor physical activities, child-directed and teacher-facilitated active play daily, short bouts of outdoor time for a total of 120 minutes each day made up of primarily unstructured free play, encouraging physical literacy by practicing fundamental movement skills, not exposing children to screen-based technology during childcare, and purposefully breaking up sustained sedentary time using physical activities).
15894147|NCT03695510|Drug|Afatinib Oral Tablet|40mg oral, daily, continuously
15894148|NCT03695510|Drug|Pembrolizumab Injection|200mg, intra-venous injection, every 3 weeks, for 35 cycles
15894149|NCT03695497|Procedure|Direct anterior approach|total hip arthroplasty with DDA
15894150|NCT03695497|Procedure|Direct Lateral Approach|total hip arthroplasty with DLA
15894151|NCT03695471|Biological|Pembrolizumab|Given IV
15894152|NCT03695458|Device|Phototherapy|The Photobiomodulation Therapy will be applied 3 minutes after MVC test in 6 points of the quadriceps muscle (2 points in vastus lateralis, 2 in rectus femoris and 2 in vastus medialis).
15894153|NCT03695445|Drug|Peripheral administration of Norepinephrine|Systematic follow-up of complications from peripheral administration of Norepinephrine
15894154|NCT03695432|Biological|Flubio|Flubio (A/California/7/2009, A/Texas/50/2012 and B/Massachusetts/2/2012) Vaccine 0,5 ml for every subjects The vaccine will be given intramuscularly
15894155|NCT03695432|Dietary Supplement|Lacidofil|Lacidofil (Lactobacillus acidophilus Rossel-52 and Lactobacillus rhamnosus Rosell-11 with maltodextrin 211 mg, magnesium stearat 8 mg and ascorbic acid 1 mg) antibiotic The antibiotic will be given 2 times each day for 6 months
15894156|NCT03695432|Other|Placebo Vaccine|Nacl 0,9% 0,5 ml The placebo vaccine will be given intramuscularly
15894157|NCT03695432|Other|Placebo probiotic|Capsul
15894158|NCT03695406|Behavioral|Mind-Body Program for Fear of Recurrence|An adapted protocol of the Relaxation Response Resiliency Program, a manualized, group-based, multimodal mind body program. Protocol adaptation includes refinement of content and study procedures to target fear of cancer recurrence (FCR) among adult cancer survivors.
15894159|NCT03695393|Behavioral|ACT Therapy|The ACT intervention will consist of three 2-hour group sessions of culturally adapted ACT (intervention) to reduce stigma and related manifestations.Participants are recruited from a civil society organization and all other study procedures take place at a rehabilitation center. The ACT sessions will be scheduled to take place at the rehabilitation center following randomization.The First St. Petersburg Pavlov State Medical University is an alternative location where sessions can be conducted. Sessions will be planned to occur in weekly succession, with a goal of 3 sessions within the first month of study participation.
15894169|NCT03695354|Device|whole body vibration plus conventional therapy|"Subjects enrolled in whole body vibration training group are exposed to side-to-side alternating vertical sinusoidal vibration. Galileo system(Novotec Medical GmbH, Pforzheim, Germany) is used to training. Frequency of whole body vibration is 12Hz and amplitude is 4mm. After 10 minutes of vibration training, subjects rest 3 minutes. Then, additional 10 minutes of training will be given.
~conventional physical therapy is consisted of passive range of motion exercise and walking exercise."
15894170|NCT03695354|Procedure|conventional therapy|conventional physical therapy is consisted of passive range of motion exercise and walking exercise.
15894171|NCT03695328|Behavioral|physical activity level|
15894172|NCT03695328|Behavioral|Dietary Intake|
15894173|NCT03695315|Device|Continuous Positive Airway Pressure|CPAP is a noninvasive treatment for sleep apnea
15894174|NCT03695302|Behavioral|questionnaire|KAP questionnaire for fifth year undergraduate dental students.
15894175|NCT03695289|Behavioral|iOTA SMI|Participants randomized to the iOTA SMI arm will undergo an assessment of individual behavior risks, will participate in collaborative goal-setting with a health coach, and will use an interactive text system that will provide ongoing support and self-monitoring of behavior change goals.
15894176|NCT03695289|Behavioral|Health Education Control|Participants randomized to the Health Education Control arm will receive monthly counseling on energy balance, physical activity and nutrition.
15894177|NCT03695276|Behavioral|PushCon Model|Pulmonary specialist consultation facilitated by a trained health coach, who will gather information from the patient and medical record prior to the consultation and will using health coaching skills to support implementation of recommended care.
15894178|NCT03695276|Behavioral|Usual care|The standard of care, which usually means management within primary care.
15894179|NCT03695263|Behavioral|Choice of one of five behavioral interventions|All participants will choose one of the five intervention options.
15894180|NCT03695250|Drug|IDO1 Inhibitor BMS-986205|Given PO
15894181|NCT03695250|Biological|Nivolumab|Given IV
15894182|NCT03695237|Drug|Leuprolide Acetate (LA)|It is administered intramuscularly as an injection
15894183|NCT03695224|Diagnostic Test|Topological perception test|Participants' topological perception are tested with self-designed devices. Participants are asked to respond to the figures shown on the screen, and a final score will appear after they finish all the questions.
15894184|NCT03695211|Procedure|Conventional landmark technique|inject at the midpoint of the posterior border of the sternocleidomastoid muscle
15894185|NCT03695211|Procedure|Precise block technique|inject at the point where the great auricular nerve emerges the posterior border of the sternocleidomastoid muscle
15894186|NCT03695198|Drug|LY3361237 - SC|LY3361237 administered SC
15894187|NCT03695198|Drug|LY3361237 - IV|LY3361237 administered IV
15894188|NCT03695198|Drug|Placebo - SC|Placebo administered SC
15894189|NCT03695198|Drug|Placebo - IV|Placebo administered IV
15894190|NCT03695185|Drug|ABBV-323 Dose A|ABBV-323 Dose A is intravenously (IV) administered.
15894191|NCT03695185|Drug|ABBV-323 Dose B|ABBV-323 Dose B is administered subcutaneously (SC).
15894192|NCT03695172|Drug|Ropivacaine|Patients will be randomly assigned to receive one three blocks (TAP, QL, ESP)after delivery of baby with ropivicaine
15894193|NCT03695172|Procedure|TAP block|Patient will receive bilateral TAP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.
15894194|NCT03695172|Biological|QL block|Patients will receive bilateral QL blocks after delivery and within one hour of skin closure with 25 mL of 0.2% ropivacaine with epinephrine 1:400,000 per side.
15894195|NCT03695172|Procedure|ESP block|Patients will receive bilateral ESP blocks after delivery and within one hour of skin closure with 25 mL of 0.2% of ropivacaine with epinephrine 1:400,000 per side.
15894196|NCT03695146|Behavioral|Paced breathing|Individuals will be fitted with a respiratory transducer and receive auditory tones with which to pace their rate of inspiration and expiration in the experimental group.
15894197|NCT03695146|Behavioral|Active relaxation|Individuals will be provided with headphones while resting quietly listening to relaxing tones/music.
15894198|NCT03695133|Behavioral|Group-based interventions|"Group-based interventions Elderly women will have a walk for physical activity for 12 weeks, three days a week. It is planned that each of the sightseeing, picnic, theater and cinema activities will be done twice. The topics that elderly women need most for group educations will be determined. Group educations will be held once every four weeks approximately three hours.
~Individual interventions After the pre-tests are applied to the women in the intervention group, the home environment and the individual's health problems will be assessed, interventions will be implemented and the results will be evaluated during home visits at online. During the home visit to the elderly women and twelve-week intervention period, each woman will meet four times and initiatives will be implemented."
15894199|NCT03695120|Other|Change of treatment plan|Withholding ACEI/ARBs during initial 72 hours of admission with acute decompensated heart failure may help preserve renal function with a lesser decline in GFR. This treatment modification will also allow the option of aggressive diuresis in volume overloaded CHF patients which should result in a lesser decline of AKI, length of stay, readmission rates, and cost associated with CHF treatment.
15894200|NCT03695107|Drug|Nifedipine controlled released tablets|lower blood pressure
15894201|NCT03695094|Drug|Padsevonil|Padsevonil (PSL) will be dosed to steady state and the effect of background therapies on pharmacokinetics will be assessed
15894202|NCT03695094|Drug|Oxcarbazepine|Concomitant administration of oxcarbazepine (OXC) at therapeutic dosage
15894203|NCT03695094|Drug|Levetiracetam|Concomitant administration of levetiracetam (LEV) at therapeutic dosage
15894204|NCT03695094|Drug|Lamotrigine|Concomitant administration of lamotrigine (LTG) at therapeutic dosage
15894205|NCT03695094|Drug|Brivaracetam|Concomitant administration of brivaracetam (BRV) at therapeutic dosage
15894206|NCT03695081|Procedure|Patient Pathway Pharmacist intervention|"Medication reconciliation at admission to hospital
~Medication review post surgery
~Optimised list of drugs in the discharge summary, in accordance with hospital procedures
~Medication reconciliation, six weeks after discharge
~Medication review, six weeks after discharge"
15894208|NCT03695055|Drug|Maintenance therapy post-HSCT|Rituximab vs DPP/DCEP-G vs observation
15894209|NCT03695042|Other|Blood Flow Restriction Training with Exercise|The addition of BFR training to an exercise program prescribed for a patient participating in physical therapy for concussion treatment. BFR training partially occludes blood flow to extremities during exercise. This allows one to exercise at lower loads and still gain benefits similar to exercise at higher loads
15894210|NCT03695029|Drug|Tenofovir Alafenamide|Pregnant women receiving tenofovir alafenamide 25 mg per day since 26-32 weeks of pregnancy to 2-4 weeks postpartum.
15894211|NCT03695016|Behavioral|ActiveGOALs|13 week, online self-directed intervention. Once weekly sessions are based on social-cognitive theory models of behavior changes. Coaches will provide weekly feedback . Behavior tracking tools will be provided. Links to tools that support physical activity will also be provided.
15894212|NCT03695003|Dietary Supplement|Cognivia|Cognivia is a trademarked sage/polyphenol combination dietary supplement from Nexira
15894213|NCT03695003|Dietary Supplement|Placebo|Placebo control capsules were prepared by Nexira also and are aesthetically identical to the Cognivia capsules
15894214|NCT03694990|Other|Follow-up schedule|Patients will be randomized into 1 of 3 follow-up schedules for post-operative clinic visits.
15894215|NCT03694977|Drug|MCS110/PDR001 combination|MCS110 7.5mg/kg iv since 1st cycle PDR001 300 mg iv since 2nd cycle Q 3weeks
15894216|NCT03694964|Drug|ProteoCIT®|30 patients will be randomized into the group that will receive 10 mg of citrulline and 30 patients will be randomized into the placebo group for 45 days
15894217|NCT03694964|Drug|Placebo Oral Tablet|30 patients will be randomized into the group that will receive 10 mg of citrulline and 30 patients will be randomized into the placebo group for 45 days
15894218|NCT03694951|Behavioral|HAPA behavioural counseling|Behavioural counseling grounded in the Health Action Process Approach (i.e., action planning and coping planning) to reduce sedentary behaviour.
15894219|NCT03694938|Device|Magnetic resonance imaging|Annually magnetic resonance imaging
15894220|NCT03694925|Diagnostic Test|Calprotectin test|Calprotectin will be measured both by ELISA and point of care test.
15894221|NCT03694912|Procedure|Partial or radical nephrectomy|The investigators perform partial or radical nephrectomy those diagnosed as RCC.
15894222|NCT03694899|Behavioral|phone contact|patients will be called prior to their outpatient appointment
15894223|NCT03694886|Drug|Caffeine Anhydrous with small sucrose pill|caffeine anhydrous that has been weighed out to 90 mg per dose presented with a 1 mm sucrose pillule
15894224|NCT03694886|Other|Placebo - large sucrose pill|sucrose pillules of 5 mm diameter will be given to all participants in the large pill groups
15894225|NCT03694886|Drug|Caffeine Anhydrous with large sucrose pill|caffeine anhydrous that has been weighed out to 90 mg per dose presented with a 5 mm sucrose pillule
15894226|NCT03694886|Other|Placebo - small sucrose pill|sucrose pillules of 1 mm diameter will be given to all participants in the small pill groups
15894227|NCT03694873|Drug|Tramadol Hydrochloride|one tablet of Tramadol 100 mg (Tramaw, Global Napi, Giza,Egypt) administered orally immediately, 12 h and 24 h after randomization.
15894228|NCT03694873|Drug|Celecoxib 200mg|Celecoxib 200 mg (Celebrex® 200, Pﬁzer,USA) administered orally immediately, 12 h and 24 h after randomization.
15894229|NCT03694860|Other|questionnaire|Members of European society of anaesthesiology care will obtain an electronic survey considering their clinical practice in RSI
15894230|NCT03694834|Drug|Pembrolizumab|"A single dose of Pembrolizumab (200 mg) will be administered IV over 30 min (-5 /+10 min) approximately 3 weeks prior to the scheduled hysterectomy.
~Pembrolizumab (200 mg) will be administered IV over 30 min (-5/+10 min) every three weeks in combination with paclitaxel and carboplatin as adjuvant therapy over 6 cycles. Pembrolizumab should be given on D1 of each cycle after the infusion of cytotoxics."
15894231|NCT03694834|Procedure|Hysterectomy|Hysterectomy/Surgical Staging per institutional standard of care.
15894232|NCT03694821|Drug|Ketorolac Tromethamine Injection|One knee injection of 2cc of ketorolac tromethamine (15mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
15894233|NCT03694821|Drug|Methylprednisolone Acetate Injection|One knee injection of 2 cc of methylprednisolone acetate (40mg/cc) in 5cc of 0.5% ropivacaine hydrochloride without epinephrine
15894234|NCT03694821|Drug|Hylan G-F 20|One knee injection of Hylan G-F 20 (Synvisc-One)
15894235|NCT03694808|Drug|Fluad Vaccine|single adjuvanted dose (AD) intramuscular injection
15894236|NCT03694808|Drug|Fluzone HD Vaccine|single high dose (HD) intramuscular injection
15894237|NCT03694782|Behavioral|Food diary supply|Each participant was issued with a food supply diary to record details of their household food supply and related trips over 1-mo period. Household food supply included food purchases, food gift/donation, and potential crops from the garden. Away-from-home food consumption was not recorded. For each food purchase, participants provided details of date, place of purchase, foods purchased (name, quantity and expense incurred), and trip made (origin/where the trip started, destination/where the trip ended, and mode of transportation). When till receipts were available in grocery stores or supermarkets, participants were asked to collect them in an envelope placed at the end of the food supply diary. To facilitate data entry, all family members were encouraged to help filling out the diary.
15894238|NCT03694782|Behavioral|Actigraph|Participants were instructed to wear a triaxial accelerometer (wGT3X-BT or wActiSleep-BT, Actigraph, Pensacola, FL, USA) fitted with an elastic strap on right side of the hip for 9 consecutive days, except for bathing and performing activities in the water. The Actigraph was accompanied by an activity logbook in which participants were required to daily record time when awake and sleeping, and, if any, time and duration of workout or device removal
15894239|NCT03694782|Behavioral|Questionnaire|Participants received by email a link to complete an online questionnaire about mental and social health, sensibility to food waste, and connection with nature
15894240|NCT03694769|Other|Semi-structured interview|One-hour interview with researcher
15894241|NCT03694769|Other|Drop attack diary|Diary of any drop attacks experienced within an 8 week period
15894242|NCT03694756|Device|TMEM-MRI|TMEM MRI INFORMATION: Unilateral breast MRI will be obtained on a 3.0T whole body MRI scanner with a dedicated breast radiofrequency coil. The patient will be scanned in the prone position with an in-dwelling IV catheter for a single dose contrast agent injection.
15894292|NCT03694379|Other|Apneic oxygenation during endotracheal intubation|Providing oxygenation through nasal cannula during the apneic phase of endotracheal intubation.
15911423|NCT03563144|Biological|GI-6301|Brachyury yeast vaccine
15894243|NCT03694756|Procedure|FNA|FNA: The patients who are recruited prior to biopsy (Cohort A) will have had TMEM-MRI performed prior to biopsy. They will then present to radiology for ultrasound-guided core biopsy of the breast mass. FNA will be performed during this procedure. The FNA will be performed after local anesthetic is administered but prior to insertion of the core biopsy needle. FNA will be performed by the radiologist under direct sonographic visualization of the mass. Five passes will be obtained with a 25 gauge needle. The FNA material will be expelled into 1.5 ml Eppendorf tube containing phosphate buffered saline with EDTA.
15894244|NCT03694743|Device|2Shape rotary system|root canal preparation
15894245|NCT03694730|Other|Exercise Treatment|Exercise treatment will consist of squatting and knee extension exercises, designed to progressively load the patellar tendon (Heavy-Slow Resistance protocol). A pain-monitoring model is used to guide exercise loads. As the protocol progresses, exercise load is increased while repetitions are decreased.
15894246|NCT03694730|Other|Pain- Guided Activity Modification|Participants sports participation and physical activity will be guided by the Pain-Monitoring Model. Using the Pain-Monitoring Model, patients may participate in activities that cause patellar tendon pain, as long as pain does not exceed 5/10 on the numeric pain rating scale (NPRS) (0 = No pain, 10 = Worst pain imaginable) during or immediately after activity. Additionally, pain should return to pre-activity levels by the following morning and pain should not increase from week-to-week.
15894247|NCT03694717|Drug|Saline Solution for Injection|The fluid expansion will consist in a less than 10 min infusion of 500 milliliters of saline through a central venous catheter (jugular). The duration of infusion will be controlled by an airbag pressurized at 300 mmHg.
15894248|NCT03694704|Device|FineHearing strategy|Cochlear implant with FineHearing strategy
15894249|NCT03694691|Diagnostic Test|Liver Biopsy|For measurement of tissue co-factor levels, we will take needle biopsies of transplanted livers immediately after procurement, immediately prior to implantation (at the end of preservation), 30 minutes after portal vein reperfusion, and 30 minutes after hepatic artery reperfusion. For those livers that have more than 60 minutes between portal vein and hepatic artery reperfusion, an additional biopsy will be performed at 60 minutes after portal vein reperfusion. Post-procurement biopsies will be collected regardless of where the liver was obtained.
15894250|NCT03694678|Behavioral|Recovering Together|The intervention will teach resiliency skills (mindfulness, coping, interpersonal communication, etc) within 2 in person sessions at hospitalization and 4 live video sessions after discharge. Both patient and caregiver will participate in all sessions
15894251|NCT03694665|Other|Lung recruitment maneuver|A Lung recruitment maneuver is aimed to resolve atelectasis during mechanical ventilation. It consists in a brief and controlled increment in airways pressure using pressure control ventilation. Positive end-expiratory pressure (PEEP) is increases every 5 centimeters of water (cmH2O), from 0 to 20 cmH2O keeping a fixed driving pressure of 20 cmH2O. A final step of 40 cmH2O of plateau pressure was maintained for 10 breaths, returning then to standard ventilatory settings.
15894252|NCT03694652|Behavioral|PACE|Patient-centered Assessment and Counseling for Exercise [PACE] program
15894253|NCT03694652|Behavioral|Diet|Motivating healthy dietary habits
15894254|NCT03694652|Other|App|Using an app to deliver communication to the participant.
15894255|NCT03694652|Other|Face-to-face|Using in person meetings and/or phone communication with the participant.
15894256|NCT03694639|Other|ganglion impar block|CT sections were done in the axial plane 4 mm slice thickness to detect the site of sacrococcygeal disk. After a suitable section was confirmed, two distances were measured, one from patient's spine to the proper site of entry and the other from the site of entry to the target point.22 gauge spinal needle 12 cm was introduced until reach anterior to sacrococcygeal disk. When the needle tip location was ideal, 2 ml lidocaine mixed with1ml of radiopaque dye was injected. CT sagittal section was done to verify the retroperitoneal distribution of the dye. After good contrast spread confirmation, 5 ml bupivacaine 5% with 14 mg/2 ml betamethasone was injected
15894257|NCT03694626|Device|Pupillography|A hand-held pupillometer/electroretinogram device (RETeval, LKC) will be held in front of the subject's eye, but will not touch the eye. The device will provide a brief, a series of brief light stimuli and then record the pupil response and the elicited electrical response from the retina from a surface skin patch (electrode) placed below each eye, from the light as a measure of whether the inherent sensitivity of the eye in the retina is normal. The investigators will repeat this in the left eye. The visible light stimulus is safe and is given at an intensity experienced in normal daily light exposures. The test takes about 2 minutes per eye.
15894258|NCT03694626|Device|Ocular Coherence Tomography (OCT)|The thickness of the optic nerve and macula will also be measured inside of the eye using a special camera that forms an image of the layers of the retina without pupil dilation. The imaging is harmless and measures the structural health of the optic nerve and retinal layers. This test takes 5-10 minutes per eye.
15894259|NCT03694626|Device|Wrist-watch sensor device|A wrist-watch sensor device (E4, Empatica) will be place on each wrist to measure skin conductance, heart rate, skin temperature and arm movement during testing. These wrist-watch devices are being used to monitor changes in sympathetic nerve activity to light intensity, (the sympathetic nerves supply the blood vessels to the skin and heart).
15894260|NCT03694626|Device|Videography|"The subject will sit comfortably in front of miniature combination infrared/visible light video cameras and infrared diode light source located within 1 meter to provide video recording of the face during testing with light and during darkness, described next.
~After the 10 minutes of dark-adapting, the subject will put his/her chin on a chin rest in front of the video cameras and a light emitting diode (LED) array give diffuse red, blue, and white stimuli over a range of intensities. None of the stimuli are as bright as a flash from a camera and are in the range of intensities normally experienced during daily activities.
~At the end of the test the investigators will add filters over the glasses: orange (blue-blocking) filters and neutral density filters. Subjects will grade independently, both the brightness and discomfort they feel from each light stimulus intensity."
15894261|NCT03694626|Device|Electrophysiology|Next, electrodes will be placed above, below and to the side of the test eye to record the electromyogram (EMG) for measuring eyelid opening and blink rate.
15894340|NCT03693989|Drug|Prednefrin|"1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator.
~- Route of administration: topical ophthalmic"
15894341|NCT03693976|Drug|Xylometazoline Nasal Spray|Application of Xylometazoline Nasal Spray in accordance with the instructions for use
15894262|NCT03694613|Other|Placental/Umbilical Cord Blood sample|After infant is delivered, placenta along with clamped umbilical cord Blood will be obtained from the ObGyn team. One umbilical clamp will be placed at the umbilical end, and the other clamp will be placed on the placental end of the umbilical cord. Then the umbilical cord will be cut between the clamps. The umbilical cord will be cleaned three times with 2% chlorhexidine, plus 70% isopropyl alcohol under sterile conditions (sterile gloves). Cord blood samples will be collected using vacutainer blood collecting system with a sterile 22-gauge needle. We will collect 3 - 4 ml of blood.
15894263|NCT03694600|Diagnostic Test|Multi-analyte blood Test|intended for the qualitative detection of DNA methylation profiles associated with hepatocellular carcinoma in cell-free DNA derived from patient whole blood specimens.
15894264|NCT03694587|Drug|Ibuprofen 200 mg TEPI Medicated Plaster|Ibuprofen 200mg TEPI medicated plaster applied to the upper back daily for 24 hours for 5 days
15894265|NCT03694587|Drug|Aktren® 200 mg überzogene Tabletten (Ibuprofen)|one dose of Aktren® 200 mg überzogene Tabletten (Ibuprofen tablet)
15894266|NCT03694574|Behavioral|instruction to suppress|"It might happen that in some situations in which you try to do something and you fail or things don't come up as you want, you could become angry, mad or irritated and feel some level of distress and discomfort. Next, try not to think of the situation that makes you angry, mad or irritated. Please try as much as you cannot to think about the situation, don't think about how you feel or what had happened, and try to suppress your emotions and not to feel them. It's very important to try as much as you cannot to think about the situation that makes you angry, mad or irritated. (Szasz, Szentagothai, & Hoffmann, 2011)"
15894267|NCT03694574|Behavioral|instruction to reappraise|"It might happen that in some situations in which you try to do something and you fail or things don't come up as you want, you could become angry, mad or irritated and feel some level of distress and discomfort. Next, please try to tell yourself that or would be preferable that the others are nice and/or fair to you, but if they are not, it does not mean that you or they are worthless human beings. It would be preferable that the others be nice and/or fair to you but if they are not, remember that it is only (very) bad), not catastrophic (the worst thing that could happen to you). It would be preferable that others are nice and/or fair to you, but if they are not, you can tolerate it, and go on enjoying life, even if it's more difficult at the beginning. (Szasz et al., 2011)"
15894268|NCT03694574|Behavioral|control|No instruction
15894269|NCT03694561|Other|Observational|This study is a systematic investigation of the natural history of late-onset Pompe disease in infancy and childhood
15894270|NCT03694548|Behavioral|Part A Survey|Survey designed to capture pain characteristics, attitudes and practices related to yoga, and potential acceptability of a yoga program for chronic pain in SCD.
15894271|NCT03694548|Behavioral|Part B Yoga Program|Eight in-person instructor-led group yoga sessions.
15894272|NCT03694535|Drug|bladder wall thermotherapy with Mitomycin-c|application of intravesical mitomycin-C with hyperthermia
15894273|NCT03694522|Drug|bemarituzumab (FPA144)|bemarituzumab (FPA144)
15894274|NCT03694522|Drug|Placebo|Placebo
15894275|NCT03694522|Drug|mFOLFOX6|mFOLFOX6
15894276|NCT03694509|Other|Breakfast tea with full fat milk|Assessment of gastric emptying using ultrasound. Black breakfast tea (200ml) with full fat milk (50ml) - The volume of milk added to the tea is at the discretion of the patient but the remaining milk must be consumed afterwards.
15894277|NCT03694509|Other|Water|Water 250ml.
15894278|NCT03694496|Behavioral|peer-led theory-based intervention group|"We plan to select 2-8 peer leaders in S2 students within each school in the intervention group. A total of 25-48 peer leaders will be selected and trained in this study.
~An experienced behavioural scientist will train the peer leaders through lectures, workshops, and individual counselling.
~A total of 6 hours training (3 hours per day x 2 days) will be conducted during weekends. Peer leaders will practice in groups, and only those who pass the evaluation are allowed to conduct peer-led interventions. We will record the performance and give specific feedback to each peer leader."
15894280|NCT03694457|Procedure|Reversed total shoulder arthroplasty|Replacement of the proximal humeral head by a reversed prosthesis through an anterior approach
15894281|NCT03694457|Procedure|lateral approach|Replacement of the proximal humeral head by a reversed prosthesis through a lateral approach
15894282|NCT03694444|Drug|AMY-101|C3 complement inhibitor
15894283|NCT03694444|Other|Water for injection|Placebo
15894284|NCT03694431|Other|Tech-supported HBPC|Palliative care provided consistent with recommendations from the National Consensus Project for Quality Palliative Care
15894285|NCT03694431|Other|Standard HBPC|Palliative care provided consistent with recommendations from the National Consensus Project for Quality Palliative Care
15894286|NCT03694418|Behavioral|We are here now: a multi-level, multi-component sexual and reproductive health intervention for American Indian youth|N/E will be implemented simultaneously over the 9-month school year. Components include: 1) Individual Level- Native Stand 2) Family Level - Native Voices; 3) Community Level - Cultural mentoring program; and 4) Systems Level. The fourth level of N/E mobilizes the existing Epi Team to enhance the coordination and implementation of SRH services at Fort Peck.
15894287|NCT03694405|Biological|MenACWY-CRM|Booster vaccination with MenACWY-CRM
15894288|NCT03694405|Biological|MenACWY-DT|Booster vaccination with MenACWY-DT
15894289|NCT03694405|Biological|MenACWY-TT|Booster vaccination with MenACWY-TT
15894290|NCT03694392|Biological|Flublok Quadrivalent|Flublok Quadrivalent vaccine is a recombinant hemagglutinin influenza vaccine indicated for active immunization against disease caused by influenza A subtype viruses and type B viruses contained in the vaccine for adults 18 years of age and older. Use of recombinant DNA techniques to produce vaccine antigen expressed in cell culture is a method that avoids growing the influenza viruses in embryonated hen's eggs.
15894291|NCT03694392|Biological|Standard Dose Inactivated Influenza Vaccine (SD-IIV)|For the 2018-2019, 2019-2020, and 2020-2021 flu seasons, the primary SD-IIVs used will be Fluarix Quadrivalent and Flulaval Quadrivalent.
15894445|NCT03693170|Drug|encorafenib|Once daily, orally
15894446|NCT03693170|Drug|Binimetinib|Twice daily, orally
15894293|NCT03694366|Other|ICBHSS model|"Bundle of evidence-based interventions that include the following 5 components:
~Community engagement meetings and feedback;
~Elimination of public sector facility user fees for children under five and pregnant women;
~Pro-active community based IMCI using trained, equipped, supervised, and salaried Community Health Workers (CHWs) with additional services including linkage to family planning and counseling, HIV testing & referrals;
~Clinical mentoring and enhanced supervision by a trained peer coach at public sector facilities;
~Basic infrastructure improvements and supply chain management training of pharmacy managers"
15894294|NCT03694353|Drug|Pegvaliase|40-60mg/day
15894295|NCT03694340|Other|Re-programming of cochlear implant|New MAP based on behavioral T- and C-levels
15894296|NCT03694327|Device|CT-101-M|Mobile Application
15894297|NCT03694327|Device|QuitGuide|Mobile Application
15894298|NCT03694314|Dietary Supplement|Omega-3 fatty acids|200 ml drink. The drink contains 840 mg total of omega-3 (360 mg of DHA, 240 mg of EPA, 200 mg of alpha-linolenic acid, and 40 mg of DPA).
15894299|NCT03694314|Dietary Supplement|Placebo|200 mL placebo fruit juice with no effect on the hypothesized outcome.
15894300|NCT03694288|Procedure|Implant removal|Surgical Implant removal
15894301|NCT03694275|Drug|Soticlestat|TAK-935 tablets
15894302|NCT03694262|Drug|Rucaparib|Rucaparib 600mg orally twice daily by continuous dosing
15894303|NCT03694262|Drug|Bevacizumab|15mg/kg IV on day 1 of every cycle
15894304|NCT03694262|Drug|Atezolizumab|1,200mg IV on day 1 of every cycle
15894305|NCT03694249|Drug|Ifetroban Sodium|Given by mouth
15894306|NCT03694249|Other|Placebo|Given by mouth
15894307|NCT03694236|Drug|durvalumab|"Neo-adjuvant chemoradiation period The treatment consisted of paclitaxel, carboplatin, duvalumab and radiation. The radiation treatment comprises 45Gy (total 25Fr) and that will be about 5 weeks. Intensity modulated RT (IMRT) or 3D CRT (three-dimensional conformal radiotherapy) will be allowed.
~Surgery Chest CT and/or PET CT with appropriate other diagnostic method (ex. Bronchoscopy) will be performed before surgery and type of surgery Follow-up period There is every 4 month visit with chest CT and abdominal CT is done at 1,2,5 post-op year. Other diagnostic method can be performed if indicated."
15894308|NCT03694223|Other|Health education delivery methods|
15894309|NCT03694210|Device|EndoRotor Therapy|To evaluate the EndoRotor's ability to safely remove non-viable/necrotic tissue for direct endoscopic necrosectomy in patients with walled off pancreatic necrosis.
15894310|NCT03694197|Drug|Praluent|Subcutaneous (SC) administration
15894311|NCT03694158|Drug|Dupilumab|anti-IL4 receptor antagonist
15894312|NCT03694158|Other|Placebo|Placebo for Dupilumab (packaged/administered the same as the active drug)
15894313|NCT03694145|Other|In-Person Eye Examination|Dilated in-person eye examination by a board-certified ophthalmologist or retinal fellow.
15894314|NCT03694132|Device|functional MRI|conditioning brain activity with peripheral stimulations
15894315|NCT03694132|Device|structural MRI|diffusion MRI and tractography for evaluating the brain structures
15894316|NCT03694132|Device|EEG/MEG|conditioning brain activity with peripheral stimulations
15894317|NCT03694119|Drug|Phenelzine|Phenelzine
15894318|NCT03694119|Drug|Tyramine|Tyramine
15894319|NCT03694119|Drug|Phenelzine placebo|Phenelzine placebo
15894320|NCT03694119|Drug|ozanimod placebo|ozanimod placebo
15894321|NCT03694119|Drug|ozanimod|ozanimod
15894322|NCT03694106|Behavioral|TEAM PSYCHOTHERAPY|Patients data will be collected from the first to the final psychotherapy session as performed normally by TEAM trained clinicians. The treatment-as-usual includes therapy sessions of 50 to 110minutes long, typically once or twice per week for an average of 8-12 sessions. Treatment as usual by these clinicians includes the use of psychological symptoms survey immediately before and after each psychotherapy session. Typically patients will fill out these surveys in the clinic's waiting area before and after each session.
15894323|NCT03694080|Combination Product|Calcium electroporation|Patients with potentially curable colorectal rectal cancer will be treated preoperatively
15894324|NCT03694067|Other|Punch skin biopsy|One 1 mm punch biopsy will be taken from the patients from balding scalp. Another 1 mm punch biopsy will be taken from an area of occipital non-balding scalp of the same individual. Local anesthesia will be injected around the biopsy site beforehand.
15894325|NCT03694054|Other|Care coordination tool|Participants will be asked to enroll in the care coordination tool, a health information technology solution that integrates cross-sector data to enhance communication and improve quality of care and performance outcomes. Patients will also be asked to provide consent to allow the study team to access additional health information via the electronic health record.
15894326|NCT03694041|Drug|SAD: APX-115|Drug: APX-115 SAD APX-115 SAD for 1day
15894327|NCT03694041|Drug|SAD: Placebo|Drug: Placebo Placebo for 1day
15894328|NCT03694041|Drug|MAD: APX-115|Drug: APX-115 MAD APX-115 MAD repeatedly administered.
15894329|NCT03694041|Drug|MAD: Placebo|Matching study drug will be repeatedly administered.
15894330|NCT03694041|Other|Food effect: fasted and fed|A single dose of APX-115, selected from the SAD study, will be administered under fasted and fed condition.
15894331|NCT03694041|Other|Metabolic probe with or without APX-115|A metabolic probe will be administered with and without APX-115.
15894332|NCT03694028|Other|Limb Loading|Participants will be assigned to one of two interventions. The intervention will occur 3 times a week for six weeks (18 sessions) each session for one hour.
15894333|NCT03694028|Other|Conventional Training|Participants will be assigned to one of two interventions. The intervention will occur 3 times a week for six weeks (18 sessions) each session for one hour.
15894334|NCT03694015|Radiation|SUPR|simple unplanned palliative radiotherapy-(either 8 Gy in 1 fraction or 20 Gy in 5 fractions), chosen pre-randomization at ROs or centres discretion
15894335|NCT03694015|Radiation|VMAT|volumetric modulated arc therapy--(either 8 Gy in 1 fraction or 20 Gy in 5 fractions), chosen pre-randomization at ROs or centres discretion
15894336|NCT03694002|Drug|Carboplatin|Given IV
15894337|NCT03694002|Drug|Paclitaxel|Given IV
15894338|NCT03694002|Biological|Ramucirumab|Given IV
15894339|NCT03693989|Drug|Difluprednate 0.05%|Dosage: 1 drop 4 times a day (every 4 hours) during the period of vigil in the operated eye, for 14 days. Dose reduction for 14 days at the discretion of the principal investigator.
15894342|NCT03693976|Device|Ectoin Rhinosinusitis Nasal Spray|Application of Ectoin Nasal Spray (SNS01) in accordance with the instructions for use
15894343|NCT03693963|Device|Serranator|The Serranator® PTA Serration Balloon Catheter is an over-the-wire (OTW) balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications.
15894344|NCT03693950|Biological|BCD-066|BCD-066 will be administered once a week intravenously in a dose 1 µg/kg
15894345|NCT03693950|Biological|Aranesp|Aranesp will be administered once a week intravenously in a dose 1 µg/kg
15894346|NCT03693937|Radiation|SRT-100|The SRT-100™ is a simple painless non-invasive in-office procedure that is approved by the U.S. Food and Drug Administration (U.S. FDA) to treat keloids caused by surgery or injury by delivering a precise, calibrated dose of Superficial Radiation Therapy (SRT) that only goes skin deep.
15894347|NCT03693924|Radiation|SRT-100|The SRT-100™ is a simple painless non-invasive in-office procedure that is approved by the U.S. Food and Drug Administration (U.S. FDA) to treat keloids caused by surgery or injury by delivering a precise, calibrated dose of Superficial Radiation Therapy (SRT) that only goes skin deep.
15894348|NCT03693911|Behavioral|Acceptance and Commitment Therapy|6 digital and gamified session prevention program based on Acceptance and Commitment Therapy
15894349|NCT03693898|Other|Observeational|No intervention, observational
15894350|NCT03693885|Other|Oxytocin challenge test (OCT)|Infusion of oxytocin 5 IU/500 ml Ringer® lactate at a rate of 12 ml/h and doubled every 10 min until three uterine contractions per 10-min interval are induced, at which point it will be stopped.
15894351|NCT03693872|Drug|Apomorphine|Apomorphine (5 mg/ml), supplied as solution for infusion in a 10 ml glass ampoule Hourly flow rate adjusted during the whole duration of the study to obtain the best effect in each patient
15894352|NCT03693872|Drug|Dopaminergic Agonist + Apomorphine|Apomorphine (5 mg/ml), supplied as solution for infusion in a 10 ml glass ampoule Hourly flow rate adjusted during the whole duration of the study to obtain the best effect in each patient and associated with dopaminergic agonists
15894353|NCT03693859|Behavioral|Cognitive enhancement program|The cognitive enhancement condition (BWL+GAMING) will both teach the behavioral skills necessary for weight loss and strengthen the executive functions that underlie these skills.
15894354|NCT03693859|Behavioral|Behavioral Weight Loss + Health Segments|Control participants will be asked to spend 30 minutes watching health segments online, five days per week, for 8 weeks.
15894355|NCT03693846|Drug|Nivolumab|IV infusion per institutional guidelines and the Package Insert
15894356|NCT03693846|Drug|Ipilimumab|IV infusion per institutional guidelines and the Package Insert
15894357|NCT03693833|Drug|Cannabidiol|Cannabidiol (CBD) tablets of 10mg each
15894358|NCT03693833|Drug|Placebo Oral Tablet|Oral Placebo tablets of 10mg each
15894359|NCT03693820|Drug|the infiltration group|"15-20 ml periportal,
~50 ml in gallbladder bed,
~The rest (about 150 ml in 70 Kg patient) will be intraperitoneal"
15894360|NCT03693820|Drug|the control group|the 50 ml prepared for gallbladder bed infiltration will be replaced by saline.
15894361|NCT03693807|Device|Medtronic pump and Codman catheter|All patients will undergo surgery to have the Medtronic pump and Codman catheter placed appropriately before HAI therapy can begin.
15894362|NCT03693807|Drug|Floxuridine (FUDR)|Please see Detailed Description.
15894363|NCT03693807|Drug|Gemcitabine|Please see Detailed Description.
15894364|NCT03693807|Drug|Oxaliplatin|Please see Detailed Description.
15894365|NCT03693807|Drug|Irinotecan (CPT-11)|Please see Detailed Description.
15894366|NCT03693807|Drug|Fluorouracil|Please see Detailed Description.
15894367|NCT03693807|Drug|Anti-EGFR (Panitumumab or Cetuximab)|Please see Detailed Description.
15894368|NCT03693781|Drug|Colchicine 1 MG Oral Tablet|Colchicine tablets depending on arm (0.01 mg/kg/day, 0.005 mg/kg/day, placebo) and on weight (>70 kg or <71 kg) for 30 weeks of duration.
15894369|NCT03693781|Drug|Colchicine 1 MG Oral Tablet|Colchicine tablets depending on arm (0.01 mg/kg/day, 0.005 mg/kg/day, placebo) and on weight (>70 kg or <71 kg) for 30 weeks of duration.
15894370|NCT03693781|Drug|Placebo Oral Tablet|Corresponding tablets for 30 weeks
15894371|NCT03693768|Behavioral|Health coaching|Health coaching
15894372|NCT03693755|Procedure|In-plane Group|Placement of femoral nerve catheter under ultrasound control
15894373|NCT03693755|Procedure|Out-of-plane Group|Placement of femoral nerve catheter under ultrasound control
15894374|NCT03693742|Diagnostic Test|18F-DCFPyL PET/CT scan|"Participants will have their weight recorded and baseline vital signs (blood pressure, heart rate, and oxygen saturation level) measured prior to the tomato juice ingestion, immediately prior to 18F-DCFPyL injection and 5 to 15 minutes after injection.
~The participant will receive a bolus intravenous dose of 18F-DCFPyL.
~After 60 min, the vital signs will be recorded and again two hours after 18F-DCFPyL. Immediately before scanning, the participants will be taken to a designated washroom and asked to void.
~The PET/CT image acquisition time will be approximately 30 minutes."
15894375|NCT03693742|Other|Placebo drink|Participants will consume 300mL of tomato juice 30 minutes prior to 18F-DCFPyL injection.
15894376|NCT03693742|Other|MSG drink|Participants will consume 300mL of tomato juice with MSG 30 minutes prior to 18F-DCFPyL injection.
15894377|NCT03693729|Device|HD-tDCS|Participants will complete a metamemory and memory task
15894378|NCT03693716|Procedure|Dynamic Anterior Stabilization|All-arthroscopic trans subscapular Long Head of the Biceps tenodesis in the anterior-inferior glenoid with all-suture anchors
15894379|NCT03693703|Diagnostic Test|bi-parametric MRI|Axial T2-weighted and diffusion-weighted imaging with no endorectal coil nor intravenous contrast agent administration
15894380|NCT03693703|Diagnostic Test|multi-parametric MRI|T2-weighted imaging in the three planes, diffusion-weighted and dynamic contrast-enhanced imaging using endorectal coil and intravenous contrast agent administration
15894381|NCT03693690|Procedure|Vaginal laser thermotherapy|Laser thermotherapy can increase the stiffness of vaginal wall. It has been reported that vaginal laser therapy can be used to treat stress urinary incontinence.
15894382|NCT03693677|Drug|Irinotecan Liposomal Injection|Nal-IRI at 80 mg/m2 IV over 90 minutes
15894383|NCT03693677|Drug|5-FU/LV|5-FU 2400 mg/m2 IV over 46-hours, every 2 weeks.
15894384|NCT03693677|Drug|Nab-Paclitaxel|Nab-Paclitaxel: 125 mg/m2 This treatment is administered at D1, D8, D15 and at D29, D36, D43.
15894385|NCT03693677|Drug|Gemcitabine|1000 mg/m² in 500 ml normal saline infusion at a fixed dose rate of 10 mg/m²/min (i.e. 100 min). This treatment is administered at D1, D8, D15 and at D29, D36, D43.
15894386|NCT03693638|Drug|Bupivacaine-fentanyl|2,5 ml total anesthetic drug dose were given with 0.2 ml/second rate, and subjects were asked to remain sitted for 90 seconds
15894387|NCT03693638|Drug|Bupivacaine-fentanyl|1,5 ml of total anesthetic drug dose followed by 1 ml remaining dose after 90 s interval were given
15894388|NCT03693625|Drug|GDC-0853|Participants were administered GDC-0853 200mg orally, as per the dosing schedules described above.
15894389|NCT03693612|Drug|feladilimab|feladilimab is humanized anti-ICOS agonist immunoglobulin G (IgG) 4 monoclonal antibody (mAb), which will be administered as an intravenous (IV) infusion once every 3 weeks.
15894390|NCT03693612|Drug|Tremelimumab|Tremelimumab is humanized anti-CTLA-4 IgG2 mAb, which will be administered as an IV infusion once every 3 weeks for 6 doses, thereafter once every 12 weeks .
15894391|NCT03693612|Drug|Docetaxel|Docetaxel is a microtubule stabilizer which will be administered as an IV infusion once every 3 weeks at a dose of 75 milligrams per meter square (mg/m^2).
15894392|NCT03693612|Drug|Paclitaxel|Paclitaxel is a microtubule stabilizer which will be administered as an IV infusion once weekly at a dose of 80 mg/m^2.
15894393|NCT03693612|Drug|Cetuximab|Cetuximab is a recombinant, human/mouse chimeric anti-estimated glomerular filtration rate (EGFR) mAb. Cetuximab will be administered at a loading dose of 400 mg/m^2 followed by 250 mg/m^2 once weekly.
15894394|NCT03693599|Drug|carbetocin|single 100 µg IV dose of carbetocin diluted in 10 ml of Ringer's lactate solution (Pabal, Ferring Pharmaceuticals Ltd, West Drayton, UK).
15894395|NCT03693599|Drug|Syntometrine|one ampoule of syntometrine (Novartis, Basel, Switzerland), which consisted of 5 IU of oxytocin and 500 microgram of ergometrine diluted in 10 ml of Ringer's lactate solution and was administered intravenously over 2 minutes
15894396|NCT03693573|Drug|Atezolizumab|Atezolizumab will be administered by intravenous (IV) infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle. Administration of study drugs will continue until unacceptable toxicity; loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status; investigator or patient decision to withdraw from therapy; or death (whichever occurs first).
15894397|NCT03693573|Drug|Bevacizumab|Bevacizumab will be administered by IV infusion at 15 mg/kg on Day 1 of each 21-day cycle. Administration of study drugs will continue until unacceptable toxicity; loss of clinical benefit as determined by the investigator after an integrated assessment of radiographic and biochemical data, local biopsy results (if available), and clinical status; investigator or patient decision to withdraw from therapy; or death (whichever occurs first).
15894398|NCT03693560|Drug|Vildagliptin 50 mg Oral Tablet|Patients who the endocrinologist prescribed them Vildagliptin 50 mg Oral Tablet plus their Metformin 1000 mg Oral Tablet to control their blood sugar level.
15894399|NCT03693560|Drug|Metformin 1000 mg Oral Tablet|Patients with Coronary artery diseases.and uncontrolled Diabetes Mellitus type 2 who's taking Metformin 1000 mg Oral Tablet only will be enrolled from endocrinology clinic.
15894400|NCT03693560|Drug|Glimepiride upto 4 mg Oral Tablet|Patients who the endocrinologist prescribed them Glimepiride 4 mg oral tablet plus their Metformin 1000 mg Oral Tablet
15894401|NCT03693547|Drug|utidelone injection|utidelone monotherapy in patients with advanced NSCLC by utidelone
15894402|NCT03693534|Diagnostic Test|Clinical Pregnancy Rate|The Clinical Pregnancy, Live Birth Rate and Blastulation Rate according to the protocol of COS
15894403|NCT03693521|Device|Handgrip strength measurement|Measurement of handgrip strength with Jamar hand-held dynamometer as a complement to standard care of patients with diabetes type 2 by diabetes-nurses.
15894404|NCT03693521|Other|Standard care|Standard care of patients with diabetes type 2 by diabetes-nurses.
15894405|NCT03693508|Drug|Genvoya®|Patents treated with elvitegravir (EVG) 150mg / cobicistat (COBI) 150mg / emtricitabine (FTC) 200mg / tenofovir (TAF) 10mg once a day as the first line treatment.
15894406|NCT03693495|Diagnostic Test|ellume·lab Group A Streptococcus Test|ellume.lab Group A Streptococcus Test is a rapid diagnostic test intended to be used as an aid in the diagnosis of Group A Streptococcus in symptomatic participants. The sample type used is a throat swab.
15894407|NCT03693495|Diagnostic Test|Bacterial Culture|Pharyngeal swab is collected from participant and this specimen is inoculated into 5% sheep blood agar plates. Beta-haemolytic colonies are isolated, followed by latex agglutination test.
15894408|NCT03693495|Diagnostic Test|Polymerase Chain Reaction (PCR)|Polymerase Chain Reaction (PCR) is a molecular diagnostic technique for the detection and identification of Group A Streptococcus, both for clinical samples and isolates. Polymerase Chain Reaction (PCR) allows template bacterial RNA to be reverse transcribed producing complementary DNA (cDNA) which can then be amplified and detected.
15894409|NCT03693482|Diagnostic Test|the Four Square Step test|A square will be formed by using four 90 cm long canes placed on the ground. The sequence will be explained and demonstrated to the participants. They will be allowed one practice trial and subsequently two trials. Instructions will be given and encouraged to complete the sequence as fast as possible without touching the canes. The sequence of trial was 1,2,3,4,1,4,3,2,1. If a participant touch the canes, or perform the test sequence inaccurately, or both feet of the participant do not make contact with the floor in each square, the trial will be considered as unsuccessful and the test will be repeated. One unsuccessful trial will be allowed. The best time will be taken as the score of FSST which are completed successfully.
15894410|NCT03693469|Device|Virtual Reality|Participants wear a Virtual Reality headset that consists of a ASUS phone and a VOX+ Z3 3D Virtual Reality Headset. The phone runs the VR Roller Coaster app to produce the virtual environment.
15894411|NCT03693456|Other|Conjunctival Allergen Challenge|Food allergen dissolved in water will be instilled in an increasing titrated fashion into the subjects eye and response will be graded according to proprietary scales.
15894412|NCT03693443|Behavioral|early childhood caries|a questionnaire evaluates the oral health beliefs, knowledge, and behaviors of a sample representing Egyptian mothers toward early childhood caries
15894413|NCT03693430|Drug|Semaglutide|Subcutaneous (s.c., under the skin) injections of semaglutide once weekly at escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks
15894447|NCT03693170|Drug|Cetuximab|Standard of care for the 28 first weeks and then every 2 weeks
15894414|NCT03693430|Drug|Placebo (Semaglutide)|S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks
15894415|NCT03693417|Device|Heated circuit on|Heated circuit will be turned on.
15894416|NCT03693417|Device|Heated circuit off|Heated circuit will be turned off.
15894417|NCT03693404|Drug|Marcaine, Duramorph , ketorolac|Subjects in the SSI group will receive an injection of 40cc 0.25% Marcaine, 5 mg Duramorph (1 mg/cc, 5 cc total), and 30 mg of ketorolac (30 mg/cc, 1 cc total) into the periosteum, and musculature surrounding the fracture site and 0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.
15894418|NCT03693404|Drug|Bupivacaine (Marcaine)|0.25% Bupivacaine (Marcaine) 10 mL into the subcutaneous tissue surrounding the surgical incision.
15894419|NCT03693404|Drug|General Anesthetics|Placebo group will only receive standard of care general anesthesia
15894420|NCT03693391|Drug|JNJ-64140284|Single dose of JNJ-64140284 up to 3 mg oral solution will be administered under fasted conditions.
15894421|NCT03693391|Drug|Fluorine-18 Labeled [18F]-JNJ-64511070|An intravenous (IV) bolus injection of 185 MegaBecquerel (MBq) [18F]JNJ-64511070 will be administered.
15894422|NCT03693365|Procedure|PEEP trial|Positive end-expiratory pressure (PEEP) is increased from 5 to 10 cmH2O during one minute.
15894423|NCT03693339|Drug|Capmatinib|Capmatinib 400 mg twice oral administration and continuously dosing (28-day treatment schedule as one treatment cycle)
15894424|NCT03693326|Drug|PDR001|PDR001 300 mg (fixed dose) intraveneously every 3 weeks
15894425|NCT03693313|Behavioral|CrossFit Kids exercise program|Participants will be actively participating in a 14 week twice weekly CrossFit Kids exercise program.
15894426|NCT03693300|Drug|Durvalumab|Participants will receive 1500 mg Durvalumab monotherapy via IV infusion q4w for up to a maximum of 24 months with the last administration at Week 104.
15894427|NCT03693287|Drug|Standardized-parenteral nutrition (S-PN)|NUMETA G13%E 300 mL is a triple-chamber (lipid emulsion, amino acids solution with electrolytes, and glucose solution), ready-to-use parenteral nutrition product available to treat preterm infants (less than 37 weeks gestational age).
15894428|NCT03693287|Drug|Personalized-parenteral nutrition (P-PN)|"Intravenous glucose will be dextrose 50%, amino acids (AA) will be Primene® and lipids (FAT) will be Clinoleic®.
~Parenteral nutrition bags will be prepared by the hospital pharmacy according to the prescription of the attending neonatologist."
15894429|NCT03693274|Behavioral|BreathAware for Pain Management|Patients will be given access to a BreathAware, a 16- week web-based mindfulness course, which will be initiated at their enrollment. BreathAware is a self-paced course comprised of 2-3 minute lessons delivered via video, audio and technology-based guided instruction, and is available on a phone or tablet.
15894430|NCT03693261|Procedure|Coronary artery bypass grafting (CABG)|CABG, as part of the standard medical care
15894431|NCT03693261|Procedure|Valve replacement|cardiac surgery for aortic or mitral valve replacement as part of their standard medical care
15894432|NCT03693248|Drug|Two cycles of neoadjuvant chemotherapy|Two and three cycles of neoadjuvant chemotherapy will be administered in experimental and control groups, respectively
15894433|NCT03693235|Procedure|bending angle of a lightwand|For tracheal intubation, investigators will bend the tracheal tube combined a lightwand by assigned angles (70, 80, or 90 degrees) for each patient. Next a practitioner will perform tracheal intubation with the bent tube.
15894434|NCT03693222|Drug|Tramadol Hydrochloride|The Wong-Baker facial pain scale was used to assess pain (1: no pain, 10: worst possible pain). During monitoring patients with pain score ≥3 had intravenous 1 mg/kg tramadol hydrochloride administered, After 15 minutes following tramadol injection, cases with pain score continuing ≥3 were to be assessed as insufficient analgesia and had 0.1 mg/kg morphine hydrochloride planned for intravenous administration.
15894435|NCT03693222|Drug|Morphine Sulfate|The Wong-Baker facial pain scale was used to assess pain (1: no pain, 10: worst possible pain). During monitoring patients with pain score ≥3 had intravenous 1 mg/kg tramadol hydrochloride administered, After 15 minutes following tramadol injection, cases with pain score continuing ≥3 were to be assessed as insufficient analgesia and had 0.1 mg/kg morphine hydrochloride planned for intravenous administration.
15894436|NCT03693209|Behavioral|Volitional Help Sheet (VHS)|VHS with a general anger trigger and 10 anger management strategies
15894437|NCT03693209|Behavioral|Volitional Help Sheet (VHS)|VHS with 10 specific anger triggers and 10 anger management strategies
15894438|NCT03693196|Other|PICF, Perio-paper®|PICF was collected from the mesio-buccal area of the implant by using paper tapes. Paper tapes were placed 1-2 mm inside the peri-implant sulcus by using a dental tweezer. After they were kept for 30 s, the paper tapes were placed in sterile microcentrifuge tubes which contained 200 µL phosphate-buffered saline (PBS). The tubes were kept at -80°C until the analysis day. TNF-α, PGE2, RANKL, RANK, and OPG, which are immunological markers of peri-implant disease were compared between groups.
15894439|NCT03693196|Other|Subgingival Plaque, Hu-Friedy®|Subgingival plaque samples were collected about 15 min after PICF was collected. Supragingival plaque was carefully removed by using a sterile scale. Implants were isolated using cotton rolls and dried with an air spray. Subgingival plaque samples were collected from the mesio-buccal area of the implant by using sterile plastic Gracey curettes during 30 s (Hu-Friedy). The samples collected were transferred to sterile microcentrifuge tubes containing 200 µL PBS. The tubes were kept at -80°C until the analysis day. Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Fusobacterium nucleatum, Prevotella intermedia, and Streptococcus oralis, which are microbiological agents of peri-implantitis were compared between groups.
15894440|NCT03693196|Other|Williams probe, PCPNU-15 Hu-Friedy®|Clinical periodontal measurements were recorded using Williams probe. The plaque index, gingival index, pocket depth, bleeding on probing, clinical attachment level, and keratinised tissue width around the implant were recorded. The implants included were categorised into three groups, namely, healthy, peri-implant mucositis, and peri-implantitis. Panoramic radiographs were acquired to assess the interproximal bone levels around the implant.
15894441|NCT03693196|Other|Demographic|Age, gender and state of smoking were compared between groups.
15894442|NCT03693183|Drug|Ketorolac/HPMC|0.30% Ketorolac/0.80%HPMC Ophthalmic solution administered 4 times per day for 2 days
15894443|NCT03693183|Drug|HPMC|0.80% Hydroxypropyl Methylcellulose solution 4 times per day for 2 days
15894444|NCT03693183|Drug|Vehicle|Vehicle
15894448|NCT03693144|Other|Full LIITA3H App|This is the full version of the LIITA3H mobile app that will use the Enhanced Location Identification (ELI) technology to identify when a user is in an eating venue and then deliver culturally and individually tailored point of purchase prompts (POP) to encourage healthy choices and will allow participants to take pictures of the food they purchase using the Self-report of Nutrients with Annotated Photos (SNAP) function.
15894449|NCT03693144|Other|Partial LIITA3H App|This is a version of the LIITA3H mobile app that will track participants' location and allow them to submit photos of their food.
15894450|NCT03693144|Other|LIITA3H Location only|This is a version of the LIITA3H mobile app that will only track participants' location.
15894451|NCT03693131|Drug|Icosapent (MND-2119)|Icosapent (MND-2119) capsules.
15894452|NCT03693131|Drug|Icosapent (EPADEL CAPSULES 300)|Icosapent (EPADEL CAPSULES 300) capsules.
15894453|NCT03693118|Behavioral|Reh1,Reh2|The initial group comprised 86 subjects including. The Nine Hole Peg Test (NHPT), administered to all of the patients, was used to evaluate the subjects' manual dexterity. The standardized scale enabled obtaining scores of high validity (right: r= 0.984, left: r = 0.993). Having been administered the NHPT test the initial 86-patient group was reduced to a cohort of 40 subjects qualified for the study, who were subsequently randomly divided into two groups - the study and the control - each consisting of 20 subjects. Three times a week the study group received the upper limb treatment by means of the cognitive function platform. They were expected to achieve 96 levels of visuo-motor coordination in 3 months or the treatment was to be terminated. Prior to the first session of the treatment the patients were provided with all relevant instructions and information about the test displayed on the monitor. They could also choose which hand they would start with.
15894454|NCT03693105|Device|Accelerated theta burst stimulation|"Participants who are randomly assigned to this group will receive active iTBS (intermittent theta burst stimulation) to the left DLPFC. Stimulation intensity will be standardized at 90% of resting motor threshold (adjusted for cortical depth).
~Stimulation will be delivered using the Magventure Magpro X100 TMS system."
15894455|NCT03693105|Device|Sham stimulation|"Participants who are randomly assigned to this group will receive sham stimulation to the left DLPFC.
~Sham stimulation will be delivered using the Magventure Magpro X100 TMS system."
15894456|NCT03693079|Procedure|Wet cupping therapy|"CT was applied using plastic disposable vacuum cups on the back in the 5 areas of C7 cervical spine (DU14 acupoint), T2-4 lateral spine bilaterally (BL41-42 acupoint) and T6-8 lateral spine bilaterally (BL44-46). The cupping technique procedure was conducted in five phases:
~Primary suction; cups are left attached to the skin for 5 minutes.
~Area disinfection; areas are wiped with sterile gauze after disinfection with povidone iodine.
~Scarification; Superficial incisions (20-30 gauge), 5 mm length and 1-2 mm depth, are made on the skin with a sterile, number 11 surgical blade.
~Bloodletting and secondary suction; the cups which had been previously removed are placed again on the scarified areas Blood leaks from the capillary vessels of the skin and subcutaneous tissue and fills the cups, which are left in place for 15 minutes.
~Removing and dressing; the cups full of blood are removed. The areas of application are wiped with sterile gauze and then a dressing is applied"
15894457|NCT03693066|Other|Ozone|In the two-visit indirect pulp therapy, due to reduce the number of bacteria remaining in the cavity, the antimicrobial agents can be used as cavity disinfectants such as ozone.
15894458|NCT03693066|Other|chlorhexidine digluconate|In the two-visit indirect pulp therapy, due to reduce the number of bacteria remaining in the cavity, the antimicrobial agents can be used as cavity disinfectants such as chlorhexidine digluconate.
15894459|NCT03693066|Other|Control|
15894460|NCT03693040|Device|Digital Health Feedback System|This intervention uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new technologies approved by the FDA, to collect information about patients taking their PrEP medication. The wearable sensor records information, which is uploaded wirelessly to a mobile device and then to a secure computer. Together the sensors and the mobile device transmitting the information to the study computer are called a digital health feedback system (DHFS), which provides information about when patients have taken their PrEP medication.
15894461|NCT03693027|Dietary Supplement|PTx800 lozenges|PTX800 is a nutritional supplement containing generally recognized as safe designated active ingredients in a rapid melt oral lozenges.
15894462|NCT03693027|Dietary Supplement|Placebo control|The placebo of PTX800 is a rapid melt oral lozenge without the active ingredients found in the PTX800 lozenges.
15894463|NCT03693014|Radiation|Stereotactic Body Radiotherapy|(27 Gy over 3 fractions)
15894464|NCT03693014|Biological|Ipilimumab, Nivolumab, Pembrolizumab or Atezolizumab|The checkpoint inhibitor that the patient was already receiving should be continued according to the standard schedule and dose of administration as determined by the treating physician. Immune Checkpoint Inhibitors include Ipilimumab (Melanoma) Nivolumab (Melanoma, Renal, NSCLC), Pembrolizumab (Melanoma, NSCLC), Atezolizumab (Bladder)
15894465|NCT03693001|Device|Intermittent Exposure to Oxygen via Oro-Nasal Mask|Patients were exposed to breathing 100% oxygen at 2 atmospheres absolute (ATA) in a multiplace pressure chamber for 90 minutes using an oro-nasal mask for 40 treatments over a 2 month period.
15894466|NCT03692988|Behavioral|Dignity Therapy|Dignity Therapy (DT) invites individuals with life-limiting illnesses to reflect on matters of importance to them and compiles them in a narrative document for the patient to share.
15894467|NCT03692975|Other|Clinical assessment|Expanded Disability Status Scale (EDSS), ambulation test and Multiple Sclerosis functional composite (MSFC). Medications will be recorded.
15894468|NCT03692975|Other|Neuropsychological evaluation|cognitive tests exploring episodic memories, information processing speed, attention/concentration and working memory.
15894469|NCT03692975|Other|Psychological evaluation|included questionnaires for depression, anxiety, fatigue, cognitive complaint and reserve
15894470|NCT03692975|Device|MRI Evaluation|Diffusion including NODDI, 3DT1 with and without gadolinium, 3D-FLAIR before and after gadolinium infusion, 3D White Matter nulled-MPRAGE, 3D Double-Inversion recovery sequences-weighted imaging and Resting state functional MRI
15894471|NCT03692962|Behavioral|Sleep restriction|Time in bed will be restricted to 5 hours per night for 7 nights.
15894472|NCT03692962|Other|Acoustic stimulation|Brief tones will be presented time-locked to ongoing slow waves during deep sleep.
15894473|NCT03692949|Drug|LY3451838|One dose administered (IV)
15894474|NCT03692949|Drug|Placebo|Administered IV
15894475|NCT03692949|Drug|Placebo|Administered SC
15894479|NCT03692897|Other|All approved therapies for the treatment of Chronic Hepatitis B (CHB)|All approved therapies for the treatment of Chronic Hepatitis B (CHB).
15894480|NCT03692871|Biological|V114|V114 pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
15894481|NCT03692871|Biological|Prevnar 13™|Prevnar 13™ pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose
15894482|NCT03692858|Drug|Adductor Canal Block plus IPACK Block|Adductor Canal Block plus IPACK Block using Ropivacaine
15894483|NCT03692858|Drug|Adductor Canal Block|Adductor Canal Block using Ropivacaine
15894484|NCT03692845|Procedure|Transforaminal Lumbar Interbody Fusion either open or minimally invasive|Spinal fusion procedure through the intervertebral foramen
15894485|NCT03692832|Procedure|LH|Laparoscopic hysterectomy (TLH or LHa)
15894486|NCT03692832|Procedure|VH|Vaginal hysterectomy
15894487|NCT03692819|Drug|Placebo Oral Tablet|Non-surgical periodontal treatment will be performed by means of periodontal debridement in a single session.
15894488|NCT03692819|Drug|Amoxicillin 500 Mg|Non-surgical periodontal treatment will be performed by means of periodontal debridement in a single session after the therapy will be administered the antibiotic (Metronidazole 400mg + Amoxicillin 500mg) every 8 hours for 7 days
15894489|NCT03692819|Drug|Lactobacillus reuteri Oral Drops|Non-surgical periodontal treatment will be performed by means of periodontal debridement in a single session after the therapy will be administered the probiotic (Lactobacillus reuteri oral drops ) twice a day for 21 days.
15894490|NCT03692806|Dietary Supplement|Stablor|Stablor sachet
15894491|NCT03692806|Dietary Supplement|placebo|placebo sachet
15894492|NCT03692793|Other|Pulmonary rehabilitation|Patients will perform continuous aerobic training (treadmill walking) during 30min (60% of the 6MWT mean speed) and progression according to dyspnea (4-6 of the modified Borg scale). Upper limbs resistance training will be performed using the modified diagonals from the proprioceptive neuromuscular facilitation method (2 sets of 2min). Lower limbs strength training will be performed for quadriceps and triceps sural (2 sets of 10 repetitions), with progression when the patients report that the exercise are ´easy´. All the muscle exercised and the breathing accessory muscles will be stretched for 30s. Eleven educational sessions will be delivered addressing topics related to COPD self-management.
15894493|NCT03692780|Drug|Careseng 1370|4,000mg granules in sachet
15894494|NCT03692780|Drug|Placebo|4,000mg granules in sachet
15894495|NCT03692767|Biological|Anti-CD22 CAR NK Cells|Anti-CD22 CAR NK Cells injection
15894496|NCT03692754|Drug|Atorvastatin 20mg|Atorvastatin will be given in 20 mg po qn for 1 month
15894497|NCT03692754|Drug|Atorvastatin 10mg|Atorvastatin will be given in 10 mg po qn for 1 month
15894498|NCT03692754|Drug|Dexamethasone|Dexamethasone will be given in 40mg po qd for 4 days
15894499|NCT03692728|Other|Psychological and Behavioral Problems|Differences in age and sex between the CC and NV groups were compared using the independent samples t test and Chi-square test, respectively. Comparisons of abnormal rates between the CC and NV groups were performed using the Chi-square test. Scores on all subscales recorded for the CC group were compared with those of the NV group and the Chinese urban norm using the independent samples t test and one-sample t test, respectively.
15894502|NCT03692702|Behavioral|WE PLAY|WE PLAY is an online preschool teacher training that is based in theory and implementation science. It contains six components: (1) online training; (2) video library; (3) game sheets; (4) teacher self-assessment; (5) supervisor support; and (6) activity packs containing low cost physical activity equipment
15894503|NCT03692689|Biological|SCT200|Recombinant Anti-EGFR Monoclonal Antibody（SCT200）
15894504|NCT03692676|Device|Spiriva Respimat|soft-mist inhaler
15894505|NCT03692663|Biological|anti-PSMA CAR NK cells|Total dose of 500 thousand-3 million /kg anti-PSMA CAR NK cells will be administered at day0
15894506|NCT03692637|Biological|anti-Mesothelin Car NK Cells|anti-Mesothelin Car NK Cells injection
15894507|NCT03692624|Behavioral|Biofeedback|Heart Rate Variability Biofeedback
15894508|NCT03692611|Behavioral|Skills TO Manage Pain (STOMP)|12 week pain self management (PSM) intervention incorporating social cognitive theory constructs.
15894509|NCT03692611|Behavioral|comparison group|Participants in this arm will receive usual care as given by providers but no behavioral PSM intervention.
15894510|NCT03692598|Device|MIA, Minimally Invasive Annuloplasty Device - Surgical|Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device from an open surgical approach
15894511|NCT03692598|Device|MIA, Minimally Invasive Annuloplasty Device - Percutaneous|Eligible patients will receive implantation of MIA implants deployed using the MIA, Minimally Invasive Annuloplasty Device from a percutaneous approach
15894512|NCT03692572|Dietary Supplement|Nitrate supplementation|Subjects will drink 70 ml of beet root juice twice a day for 2 weeks.
15894513|NCT03692572|Dietary Supplement|placebo|Subjects will drink 70 ml of nitrate depleted placebo juice twice a day for 2 weeks.
15894514|NCT03692559|Other|full aseptic dressing|Replacement of the central venous catheters in the dressing process
15894515|NCT03692546|Drug|Liposomal bupivacaine (LB)|Addition of LB solution to soft tissue surgical field block to a standard interscalene block procedure
15894516|NCT03692533|Diagnostic Test|Immunohistochemistry|"Histopathological study and evaluation:
~For each case, the tissue samples will be evaluated by the pathologist for detecting the histopathology and in cases of malignant renal spicemens the pathologist will also assess the histologic type, Fuhrman nuclear grade, cellular invasion of perinephric fat, and the extent of any vascular invasion seen by microscopy.
~Immunohistochemistry:
~Immunohistochemical staining will be performed by using the following antibodies: Geminin and Minichromosome maintenance-2 (MCM-2).
~Evaluation of the immunohistochemical staining will be performed by light microscopy. The interpretation of immuno-reactivity will be performed in a quantitative manner by analyzing the extent of the staining positivity of the tumor cells. Immuno-staining of greater than 10% of tumor cells is required for scoring as a positive case."
15894518|NCT03692507|Dietary Supplement|HMB|Patients in the first group (HMB only) will take 3 capsules of HMB by VitaMonk™ (1000mg/capsule) daily (morning, noon, and night) for 5 days prior to surgery.
15894519|NCT03692507|Dietary Supplement|Protein and HMB|Patients in the second group (HMB + protein) will drink 2- 8oz bottles of Ensure Enlive daily (morning and night) for 5 days prior to surgery. Each bottle contains 1500mg of HMB and 20 g of protein.
15894520|NCT03692507|Dietary Supplement|ERAS|Patients in the third group (High protein) will drink 2- 8oz bottles of Ensure surgery daily (morning and night) for 5 days prior to surgery. Each bottle contains 18g of protein. and a clear 50g Pre-surgery drink on the day of surgery
15894521|NCT03692494|Other|Standard of care voice therapy|Exercises will include improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relaxation techniques to the neck and shoulder
15894522|NCT03692494|Other|Expiratory muscle strength training (EMST)|EMST150 used at 75% of their maximum expiratory pressure. Participants will be directed to perform 5 sets of 5 breaths, 5 days per week, for 5 weeks, at the pressure threshold established in therapy. Maximum expiratory pressure will then be determined at the beginning of each therapy session and recalibration of the device will be performed if indicated.
15894523|NCT03692481|Radiation|18FDG-PET scan|18FDG PET scan will be performed in each patient before initiation of pirfenidone and after 12 weeks of treatment
15894524|NCT03692468|Behavioral|Psychotherapy|Participants will complete 5, 60 minutes sessions. At each session, participants will learn strategies that have been shown to improve pain functioning and/or mood for patients who have chronic pain. The intervention will be delivered in the patient's primary care clinic.
15894525|NCT03692455|Procedure|Roux-en-Y Gastric Bypass|The Roux-en-Y gastric bypass procedure involves creating a stomach pouch out of a small portion of the stomach and attaching it directly to the small intestine, bypassing a large part of the stomach and duodenum. Not only is the stomach pouch too small to hold large amounts of food, but by skipping the duodenum, fat absorption is substantially reduced.
15894526|NCT03692455|Procedure|Vertical Sleeve Gastrectomy|VSG surgery restricts food intake and decreases the amount of food used. Most of the stomach is removed during this surgery, which may decrease ghrelin, a hormone that prompts appetite. Lower amounts of ghrelin may reduce hunger more than other purely restrictive surgeries, such as AGB.
15894527|NCT03692429|Drug|CYAD-101|Allogeneic NKG2D-based CYAD-101 Chimeric antigen Receptor T-cells
15894528|NCT03692429|Drug|FOLFOX|5-FU, leucovorin and oxaliplatin
15894529|NCT03692429|Drug|FOLFIRI|5-FU, leucovorin and irinotecan
15894530|NCT03692416|Drug|Ibuprofen|"Infants and children with vasculitis attending AssiutU, aged > 1 mo. - 17 yr. of both genders will be included during 2 years of study.
~Besides full clinical history and thorough examination, all cases will have: CBC, CRP, ESR, Renal function tests & Albumin / creatinine ratio.
~All cases will have an initial estimation as well as follow up estimation after treatment by Ibuprofen for ANCA, C3, C4 &C5a levels done, measured By ELISA technique."
15894531|NCT03692416|Drug|Prednisone|"Infants and children with vasculitis attending AssiutU, aged > 1 mo. - 17 yr. of both genders will be included during 2 years of study.
~Besides full clinical history and thorough examination, all cases will have: CBC, CRP, ESR, Renal function tests & Albumin / creatinine ratio.
~All cases will have an initial estimation as well as follow up estimation after treatment by Steroids for ANCA, C3, C4 &C5a levels done, measured By ELISA technique."
15894532|NCT03692416|Drug|Methotrexate|"Infants and children with vasculitis attending AssiutU, aged > 1 mo. - 17 yr. of both genders will be included during 2 years of study.
~Besides full clinical history and thorough examination, all cases will have: CBC, CRP, ESR, Renal function tests & Albumin / creatinine ratio.
~All cases will have an initial estimation as well as follow up estimation after treatment by Methotrexate for ANCA, C3, C4 &C5a levels done, measured By ELISA technique."
15894533|NCT03692403|Drug|Quinagolide 360 µg|Vaginal ring containing quinagolide 360 µg for daily releases
15894534|NCT03692403|Drug|Quinagolide 720 µg|Vaginal ring containing quinagolide 720 µg for daily releases
15894535|NCT03692403|Drug|Quinagolide 1080 µg|Vaginal ring containing quinagolide 1080 µg for daily releases
15894536|NCT03692403|Drug|Placebo|Matching placebo
15894537|NCT03692390|Device|Virtual Reality|Participants wear a Virtual Reality headset that consists of a ASUS phone and a VOX+ Z3 3D Virtual Reality Headset. The phone runs the VR Roller Coaster app to produce the virtual environment.
15894538|NCT03692377|Device|Virtual Reality|Stage 1 : Demonstration of the use of the VR headset by the research assistant (anticipated 1-2 min) Stage 2 : Child will choose the application they would like to see - they will be shown 3 pages of the three applications offered - see Fig 1 (anticipated 1-2 min) Stage 3 : Handling of the VR headset by the child (anticipated 1 min) Stage 4 : Applying the headset on the eyes of the child with software application (anticipated 1 min) Stage 5 : The child use the VR set and application (up to 10 minutes) Stage 6 : Removal of the headset (anticipated 1 min) Stage 7 : Questionnaire to child (interview - 2 minutes) Stage 8 : Questionnaire to parents/guardians (interview - 2 minutes)
15894539|NCT03692364|Device|Ceramic-on-ceramic uncemented hip arthroplasty|
15894540|NCT03692364|Device|Metal-on-polyethylene uncemented total hip arthroplasty|
15894541|NCT03692351|Device|Uncemented acetabular cup with screw holes|
15894542|NCT03692351|Device|Uncemented acetabular cup without screw holes|
15894543|NCT03692338|Behavioral|Exercise|Patients will be asked to complete 3 x 30 minute exercise sessions each week.
15894544|NCT03692325|Drug|Nivolumab|Nivolumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells.
15894545|NCT03692312|Drug|Tideglusib|Tideglusib for oral suspension, weight-adjusted at 400mg, 600mg or 1000 mg dose levels, once daily
15894546|NCT03692312|Drug|Placebo|Matching placebo formulation
15894547|NCT03692299|Drug|Saccharomyces Boulardii Oral Tablet|Saccharomyces boulardii 200 mg b.i.d. during 2 weeks, followed by a 2-week rest period and then again 200 mg b.i.d. during 2 consecutive months.
15894548|NCT03692299|Drug|Metronidazole|Metronidazole 500 mg b.i.d during 1 week, followed by a 3-week rest period and then again 500 mg b.i.d during 2 consecutive months
15894549|NCT03692286|Combination Product|Silver nanoparticle/Calcium hydroxide|Intracanal Medication composed of combined silver nanoparticles with calcium hydroxide
15894550|NCT03692286|Drug|Silver Nanoparticles in gel form|Intracanal medication composed of silver nanoparticles in gel form
15894552|NCT03692273|Procedure|Luminis ultrapulse fractional ablative carbon dioxide laser|This laser will target water molecules and ablate columns of tissue that are approximately 3mm deep.
15894553|NCT03692273|Procedure|0.5mm punch biopsy|punch biopsies will be performed to remove approximately equivalent volumes of tissue compared to the laser
15894554|NCT03692260|Procedure|3D stent in Herbert screw insertion vs titanium plate|benefit of 3d template in fracture gap
15894555|NCT03692247|Other|Smartphone-based Music Intervention|The smartphone-based music intervention (Unwind) is a music protocol that gathers basic information from the patient including a 0-10 pain scale and 0-10 anxiety scale as well as recorded heart rate. Using these variables, a machine learning protocol pieces together a music intervention between 5-20 minutes long. The duration of the intervention can be controlled by the patient or experimenter. No identifying data is kept on the smartphone.
15894556|NCT03692234|Dietary Supplement|125 mg L-homoarginine|capsules for oral supplementation
15894557|NCT03692234|Other|placebo|capsules for oral supplementation
15894558|NCT03692221|Drug|MSC Treatment group 1 (low dose)|Autologous Bone Marrow Derived Mesenchymal Stem Cells (MSC) - A one time injection of 1-2 ml of a 4 x 106/ml concentration solution
15894559|NCT03692221|Drug|MSC Treatment group 2 (high dose)|Autologous Bone Marrow Derived Mesenchymal Stem Cells (MSC) - A one time injection of 1-2 ml of a 4 x 106/ml concentration solution
15894560|NCT03692221|Other|Healthy Control (no treatment)|Comparative analysis of psychometric and morphometric based data
15894561|NCT03692208|Behavioral|My Diabetes Goal Survey and Optional Care Management|The intervention is already described in the intervention arm description.
15894562|NCT03692195|Device|WHOOP Strap 2.0|The WHOOP Strap 2.0 is worn on the wrist, continuously throughout the 7-day period of which participants will be assigned. It measures heart rate, sleep, strain, and recovery.
15894563|NCT03692195|Other|No Device|The WHOOP Strap 2.0 is not worn on the wrist for a seven day period.
15894564|NCT03692169|Procedure|Half-dose photodynamic therapy|Half-dose photodynamic therapy was achieved by administering 3mg/m² of Verteporfin (Visudyne; Novartis, Switzerland) intravenously over a period of 10 minutes. Fifteen minutes after commencing the verteporfin infusion the greatest linear dimension was exposed to a 689 nm laser light with a florescence of 600 mw/cm² for 83 seconds and a total energy of 50 J/cm². Optical coherence tomography angiography (OCTA) with the split-spectrum amplitude-decorrelation angiography algorithm (XR Optovue, Fremont, CA, USA) and spectral domain OCT (SD-OCT) were performed at baseline and each follow-up (one month and three months) visit after hd-PDT.
15894565|NCT03692143|Drug|Teriparatide|subcutaneous injection of teriparatide(20 mg) once daily
15894566|NCT03692143|Procedure|PVP|With local anesthesia, bone cement was injected in to fractured body in a needle that penetrated transpedically and percutaneously
15894567|NCT03692143|Drug|Alendronate|Alendronate Sodium, oral, 70mg, once a week
15894568|NCT03692130|Behavioral|Mindfulness, Acceptance and Commitment-Therapy|Psychotherapeutic intervention to treat depressive patients with special exercises and education to be mindful, to accept situations and behaviors and to commit with the situation or the possibility to change.
15894569|NCT03692130|Behavioral|Jacobson|Relaxation treatment in technique of Jacobson
15894570|NCT03692117|Device|Extracorporeal Carbon Dioxide Removal|Place a double lumen catheter in jugular vein, drainage the venous blood in vitro tube, after blood-gas exchange and remove CO2, then return back to the Superior vena cava
15894571|NCT03692104|Diagnostic Test|transrectal ultrasound|Use of US for post implant quality assessment
15894572|NCT03692091|Procedure|Subacromial Injection|Injection in to subacromial space in the shoulder from anterior portal
15894573|NCT03692078|Other|OTDN product 1|Oral tobacco-derived nicotine product
15894574|NCT03692078|Other|OTDN product 2|Oral tobacco-derived nicotine product
15894575|NCT03692078|Other|Tobacco Cessation|Tobacco Cessation
15894576|NCT03692065|Drug|Apixaban 5 MG|Subjects will be randomized (1:1 ratio) to apixaban 5 mg bid (full dose) or apixaban 2.5 mg bid (reduced-dose) using a centralized IWRS (double blind study).
15894577|NCT03692052|Drug|AG-348|"Core period: Participants will receive an initial AG-348 dose of 50 mg BID, oral tablets, and may undergo one potential dose-level increase to 100 mg BID, based on an evaluation of the participant's safety profile and Hb concentrations.
~Extension Period: Participants who achieve a Hb response with an acceptable safety profile will continue receiving treatment with AG-348 for up to an additional 10 years at the same dose they were receiving at the Week 24 Visit."
15894578|NCT03692039|Procedure|M-pro files in rotating motion|An endodontic file that has controlled memory properties
15894579|NCT03692039|Procedure|ProTaper Next files in rotating motion|An endodontic file that has an off center mass of rotation
15894580|NCT03692026|Procedure|Immediate implant placement|implants will be placed in freshly extraction sockets with or without application of Hyaluronic acid and Melatonin mixture.
15894581|NCT03692026|Drug|Hyaluronic acid and Melatonin Mixture|a mixture of hyaluronic acid and melatonin will be prepared and added topically to the implant surface, extraction socket and peri-implant area for the study group
15894582|NCT03692013|Drug|Losartan|Participants will be divided into 2 groups as daytime group and nighttime group The participants in daytime group will take 100-200mg Losartan in the morning between 6AM to 8AM. The participants in nighttime group will take 100-200mg Losartan at night between 9PM to 11PM .
15894583|NCT03691987|Biological|Preprocessed thawed donor FMT|Delivered as an enema using the same equipment and technique as X-ray of the colon
15894584|NCT03691987|Biological|Preprocessed thawed autologous FMT|Delivered as an enema using the same equipment and technique as X-ray of the colon
15894585|NCT03691974|Drug|Fasinumab|Subcutaneous (SC) every four weeks (Q4W)
15894586|NCT03691974|Other|Placebo|Subcutaneous (SC) every four weeks (Q4W)
15894587|NCT03691961|Other|Hair sampling|After 4 months of treatment, a strand of hair from the vertex posterior region of the scalp about the width of a thin pencil and with a length equal to or greater than 3 cm will be cut.
15894588|NCT03691961|Diagnostic Test|Hair's drug concentrations|The hair's concentrations of budesonide/formoterol is analysed with mass spectrometry.
15894626|NCT03691727|Behavioral|Questionnaires|Quality of Life in Brain Injury - Overall Scale (QOLIBRI-OS) and the Lawton Instrumental Activities of Daily Living (IADL) will be administered at 6 month and 1 year follow up visits.
15911424|NCT03563144|Biological|haNK|NK-92 [CD16.158V, ER IL-2]
15894589|NCT03691948|Other|Responsible Opioid Prescriber Education (ROPES)|The ROPEs intervention is a self-guided, web-based continuing dental education intervention. Consistent with ADA recommendations, ROPEs consists of seven modules of active content: (1) Overview; (2) Background on the Opioid Epidemic; (3) Dental Pain Management and the Role of Opioids; (4) Universal Precautions Approach; (5) Screening, Monitoring, and PDMP use; (6) Providing Patient Education; and, (7) Case Vignettes. All key intervention content is delivered via video-based platform and includes downloadable practice aides and resources.
15894590|NCT03691948|Other|Active Comparator Control|An online PDF version of the Center for Disease Control Guideline for Prescribing Opioids for Chronic Pain.
15894591|NCT03691935|Drug|Ropivacaine|Erector Spinae Block with ropivacaine infusion with standard of care analgesics for perioperative pain control
15894592|NCT03691935|Drug|Normal saline|Erector Spinae Block with saline infusion with standard of care analgesics for for perioperative pain control
15894593|NCT03691922|Procedure|Erector Spinae Plane (ESP) Block|"Preoperative US guided ESP blockade using 30 mL of 0.25% bupivacaine with 5 mcg/mL of epinephrine, injected in 5-mL aliquots through the needle (maximum of 3 mg/kg)
~PAI of 30 mL of saline at the end of the surgical procedure on the operated side rotator cuff, injected in 5-mL aliquots through the needle"
15894594|NCT03691922|Procedure|Periarticular Infiltration (PAI)|"Preoperative US guided ESP blockade using 30 mL of saline, injected in 5-mL aliquots through the needle
~PAI of 30 mL of 0.25% bupivacaine with 5 mcg/mL of epinephrine at the end of the surgical procedure on the operated side rotator cuff, injected in 5-mL aliquots through the needle"
15894595|NCT03691909|Biological|HB-adMSCs|Hope Biosciences autologous adipose-derived mesenchymal stem cells
15894596|NCT03691896|Dietary Supplement|Cholecalciferol 400|dose 400 UNT/day for 12 months
15894597|NCT03691896|Dietary Supplement|Cholecalciferol 800|dose 800 UNT/day for 12 months
15894598|NCT03691896|Drug|Cholecalciferol 1200|dose 1200 UNT/day for 12 months
15894599|NCT03691870|Procedure|Standard Trans-Arterial Embolization (TAE)|"The standard TAE, without TVE, is used in patient allocated standard treatment. The arterial approach will consist of at least one attempted catheterization for trans-arterial injection of liquid embolic.
~If the operator deems, on the table, for a trans-arterial injection to be too dangerous, no arterial injection is necessary. Treatment, where indicated, can be completed through other means."
15894600|NCT03691870|Procedure|Trans-Venous Embolization (TVE)|"The experimental treatment is an attempt to completely occlude the AVM using venous catheterization and retrograde EVOH injection during the final session.
~The trans-venous strategy will consist of at least one transvenous injection of ethyl vinyl alcohol (EVOH), with the choice of delivery microcatheters and other technical details left to the individual operator's discretion."
15894601|NCT03691857|Procedure|Ultrasound algorithm (EMERALD-US)|Ultrasound algorithm EMERALD-US is an dedicated to emergencies using lung, cardiac and vascular ultrasound for the 3 main dyspnea causes (heart failure, pneumonia and obstructive pulmonary disease exacerbation) in patients with acute non-traumatic dyspnea managed in the emergency department. The ultrasounds will be performed within first hour after first medical contact in emergency department by another emergency physician not in charge of the patient. The ultrasound results will be not shared with the emergency physician in charge of the patient.
15894602|NCT03691844|Drug|AMZ001|diclofenac gel
15894603|NCT03691844|Drug|Placebo|Placebo
15894604|NCT03691844|Drug|Comparator|diclofenac gel
15894605|NCT03691831|Drug|Active|A-101 45% (hydrogen peroxide 45% topical solution)
15894606|NCT03691831|Other|Vehicle|Vehicle solution containing isopropyl alcohol and water
15894607|NCT03691818|Drug|X0002 Spray|According to the different dose groups assigned, each knee joint was sprayed with 1, 2 or 4 sprays.
15894608|NCT03691818|Drug|Ibuprofen Tablet|Ibuprofen Tab 400mg, tid.
15894609|NCT03691818|Drug|Ibuprofen Placebo Tab|Ibuprofen Placebo Tab 400mg, tid.
15894610|NCT03691818|Drug|X0002 Placebo Spray|According to the different dose groups assigned, each knee joint was sprayed with 1, 2 or 4 sprays.
15894611|NCT03691805|Device|tDCS|The participants will receive anodal tDCS (transcranial direct current stimulation) of the right dorsolateral prefrontal cortex for 20 minutes on five consecutive days.
15894612|NCT03691805|Device|Sham tDCS|The participants will receive sham tDCS (transcranial direct current stimulation) of the dorsolateral prefrontal cortex for 20 minutes on five consecutive days.
15894613|NCT03691792|Behavioral|Cognitive-Behavioral Therapy (CBT-SAD)|12 group sessions over 6 weeks
15894614|NCT03691792|Other|Light Therapy|10,000-lux initiated at 30 min upon waking and adjusted per treatment algorithm, continuing for 6 weeks
15894618|NCT03691766|Other|Photobiomodulation Therapy|Photobiomodulation therapy, a mix of red lights thought to improve mitochondrial function will be applied in and acute and chronic manner to test whether muscle fatigue improves in persons with MS.
15894619|NCT03691766|Other|Placebo|Device with sham light source
15894620|NCT03691753|Device|Fitaya Vena Cava Filter System|After the implantation of Fitaya Vena Cava Filter, the filter can be withdrawn from the patient within the window period (60 days) by using the withdraw system in junction of the sheath.
15894621|NCT03691753|Device|Aegisy Vena Cava Filter|After the implantation of Aegisy Vena Cava Filter, the filter can be withdrawn from the patient within the window period (60 days) by using the withdraw system in junction of the sheath.
15894622|NCT03691740|Device|Ocular light|A light mask to which small light emitting diode(LED) lights emitting a blue or red color light will be used to deliver ocular light
15894623|NCT03691727|Drug|tirofiban hydrochloride (AGGRASTAT®)|Participants will have intravenous Aggrastat administered continuously over the course of 7 days in the setting of subarachnoid hemorrhage at least 12 hours post clinically indicated Endovascular Coil Embolization procedure.
15894624|NCT03691727|Diagnostic Test|MRI|Participants will undergo 2 MRIs administered within 24 hours post Coil Embolization procedure and prior to discharge to monitor for ischemic changes.
15894625|NCT03691727|Diagnostic Test|Neurological Exam|Neurological exams will be done at screening, randomization, days 2-7, discharge, 6 week, 6 month, and one year follow up visits.
15895377|NCT03686085|Drug|placebo vaginal tablet|1 vaginal tablet of placebo inserted by the study nurse 6 hours before IUD insertion.
15894627|NCT03691727|Diagnostic Test|Vital Signs|Vital signs which include temperature, respiration rate, blood pressure and O2 stats will be done at screening, randomization, days 2-7, discharge, 6 week, 6 month, and one year follow up visits.
15894628|NCT03691727|Other|Standard of Care Treatment|Participants will receive standard of care treatment and will not receive study drug.
15894629|NCT03691714|Drug|Durvalumab|One hour infusion
15894630|NCT03691714|Drug|Cetuximab|Two hour infusion for loading dose followed by weekly one hour infusion
15894631|NCT03691701|Other|strict blood pressure control|Home SBP target < 120 mmHg or 90th percentile for age and height (whichever is lower)
15894632|NCT03691688|Drug|Aspirin 100 mg|Aspirin 100mg will be prescribed for antiplatelet therapy at the physician's discretion
15894633|NCT03691688|Drug|Clopidogrel 75mg|Clopidogrel will be prescribed for antiplatelet therapy in case of aspirin intolerance at the physician's discretion
15894634|NCT03691675|Device|Drug coated balloon|Patients with de novo lesion whose radiography showed that target lesion diameter stenosis is ≥50%, reference diameter is ≥2.75mm and who agreed with the Drug coated balloon dilatation therapy
15894635|NCT03691662|Drug|DE-117 Ophthalmic Solution|Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months
15894636|NCT03691662|Drug|Timolol Maleate Ophthalmic Solution 0.5%|Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months
15894637|NCT03691649|Drug|DE-117 Ophthalmic Solution|Topical DE-117 Ophthalmic Solution once daily and Vehicle once daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only
15894638|NCT03691649|Drug|Timolol Maleate Ophthalmic Solution 0.5%|Topical Timolol Maleate Ophthalmic Solution 0.5% twice daily for 3 months for all subjects, followed by DE-117 Ophthalmic Solution once daily for additional 9 month for adult subjects only
15894639|NCT03691636|Device|Eyelash prostheses|Eyelash prostheses are essentially specialized eyelash extensions
15894640|NCT03691636|Device|5.0% Lifitegrast Ophthalmic Solution|5.0% Lifitegrast Ophthalmic Solution
15894641|NCT03691623|Drug|EDP-938 Dose 1|Oral suspension for 5 days
15894642|NCT03691623|Drug|EDP-938 Dose 2|Oral suspension for 5 days
15894643|NCT03691623|Drug|Placebo|Oral suspension for 5 days
15894644|NCT03691623|Drug|EDP-938 Dose 3|Oral suspension for 5 days
15894645|NCT03691623|Drug|EDP-938 Dose 4|Oral suspension for 5 days
15894646|NCT03691623|Drug|Placebo|Oral suspension for 5 days
15894658|NCT03691597|Diagnostic Test|improved patient satisfaction ,marginal integrity, shade match and gingival health|"For both groups N.Awill make a recall visit after6 months and after 12 months:
~Patient satisfaction will be performed according to questionnaire after One year.Questionnaire will contain several questions that evaluate patient satisfaction.
~The color will be measured using spectrophotometer Vita easy shade in the same delivery visit ,after 6months and after one year .
~Images will be captured using digital handheld light microscope (Celestron 5 Megapixel Resolution, USA) that is fixed on a film holder on a specific distance for the standardization of all the images will be captured by the microscope for all the patients.(22)
~Images will be analyzed using imageJ software to measure marginal gap.
~Gingival health will be measured using G"
15894659|NCT03691584|Drug|TP-6076|The dose planned to be administered in this study is an iv infusion of 30 mg TP 6076 q24h for 4 consecutive days (starting on Day 1 and ending on Day 4).
15894660|NCT03691584|Procedure|Bronchoalveolar lavage|Subjects will be randomized to undergo a BAL at a single time point: either 2, 4, 8, or 24 hours after the start of the final TP-6076 iv infusion on Day 4.
15894661|NCT03691571|Device|Esophageal Cooling|The EnsoETM is a non-sterile multi-lumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while simultaneously allowing gastric decompression and drainage.
15894662|NCT03691571|Device|Control|Standard of care involves standard temperature probe monitoring.
15894663|NCT03691558|Other|Ketogenic diet|total daily caloric intake was divided into 5 meals. Individual daily caloric need is calculated referring to body composition and adjusted for daily activity (Frankenfield, Roth-Yousey, & Compher, 2005; Wang et al., 2000). Macronutrients percentage is 68% fat, 26% protein and 6% carbohydrate Paoli et al. 2013). Very low carbohydrate foods that simulate carbohydrates taste food like croissants, bread and cracked slices made by Le Gamberi Foods (Forlì, Italy), are used for a better compliance to the dietary intervention
15894733|NCT03691051|Drug|Pyrotinib plus Capecitabine|Pyrotinib:400mg/d,q.d.,p.o. A course of treatment need 21days. Capecitabine:1000mg/m2,bid,from day1-day14, A course of treatment need 21 days.
15894664|NCT03691558|Other|Western Diet|total daily caloric intake was divided into 5 meals. Individual daily caloric need is calculated referring to body composition and adjusted for daily activity (Frankenfield, Roth-Yousey, & Compher, 2005; Wang et al., 2000). The diet macronutrient percentage distribution is the following: protein is 25% of TDC (total daily calories), fat is 20% of TDC and carbohydrates represented the 55% of TDC
15894665|NCT03691545|Behavioral|interactive sessions|This arm will receive personalized health coaching (behaviour change counseling)
15894666|NCT03691532|Behavioral|Seated control (CON)|Seated rest
15894667|NCT03691532|Behavioral|Arm cycle exercise (ACE)|Arm cycling at a continuous power output
15894668|NCT03691532|Behavioral|Liquid meal|Liquid meal of 0.5 L volume containing 20 kcal/kg fat free mass (FFM) and 5 mg/kg FFM of uniformly 13-carbon labeled palmitate ([U-13C]palmitate) at a macronutrient distribution of 50% carbohydrate, 35% fat, and 15% protein (by kcal).
15894669|NCT03691519|Drug|Omega-3 treatment|"Patient in the treatment comparative arm will consume 3- 1g softgel vegetarian capsules of DHA-O per day as a single dose for 36 months; each 1g capsule of DHA-0 providing 324 mg DHA and 185 mg EPA (total daily DHA+EPA dose = 1.53 g/day)."
15894670|NCT03691519|Dietary Supplement|Placebo|"The appearance and taste of the placebo will be similar to those of the active ingredient. Placebo capsules contained a 1:1 ratio of corn oil and soy oil.
~36 months consisting of a 18-month placebo-controlled period followed by a 18-month open-label extension period wherein all participants will receive active treatment. Active treatment consists of 1.53 g /day dose of DHA-0 (972 mg /day DHA + 555 mg /day EPA; 3 caps /day).
~For the 18 months placebo-controlled period (n=200/arm): 1.53 g /day dose of DHA-0 (972 mg /day DHA + 555 mg /day EPA; 3 caps /day) or placebo (3 similar pills /day)."
15894671|NCT03691506|Other|Classic CIMT group|Constraint Induced Movement Therapy (CIMT) is a new treatment technique that claims to improve the arm motor ability and the functional use of a paretic arm - hand. CIMT forces the use of the affected side by restraining the unaffected side. Child with hemiplegic cerebral palsy can learn to improve the motor ability of the more affected parts of their bodies and thus cease to rely exclusively or primarily on the less affected parts.
15894672|NCT03691506|Other|Modified CIMT group|Modified CIMT protocol that was based on suggestions made by Dromerick, Edwards, and Hahn (2000) . Modifications were reductions in the duration of mitt wear and massed practice compared with the traditional protocol
15894673|NCT03691493|Drug|Anastrozole|Given PO
15894674|NCT03691493|Drug|Exemestane|Given PO
15894675|NCT03691493|Drug|Fulvestrant|Given IM
15894676|NCT03691493|Drug|Letrozole|Given PO
15894677|NCT03691493|Drug|Palbociclib|Given PO
15894678|NCT03691493|Radiation|Radiation Therapy|Undergo radiation therapy
15894679|NCT03691493|Drug|Tamoxifen|Given PO
15894680|NCT03691480|Procedure|simple exsufflation|simple exsufflation
15894681|NCT03691480|Procedure|Fuhrman catheter and ambulatory care|Fuhrman catheter and ambulatory care
15894682|NCT03691467|Device|immediate dental implant|immediate dental implant placement in freshly extracted socket.
15894683|NCT03691467|Drug|Hyaluronic Acid|topical application of hyaluronic acid
15894684|NCT03691454|Drug|Docetaxel|Docetaxel 50mg/m2, intravenous drip, D1, combined with Oxaliplatin 85mg/m2，intravenous drip 2h，D1 and S-1 40-60mg bid(BSA<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2, 50mg bid, BSA>1.5m2, 60mg bid)，D1-7；For patients with Her2 positive, add Herceptin 4mg/kg(6mg/kg first cycle) D1; every 14 days for a cycle.
15894685|NCT03691454|Drug|Oxaliplatin|Oxaliplatin 130mg/m2，intravenous drip 2h，D1 combined with S-1 40-60mg bid(BSA<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2, 50mg bid, BSA>1.5m2, 60mg bid)，D1-14；For patients with Her2 positive, add Herceptin 6mg/kg(8mg/kg first cycle) D1; every 21 days for a cycle.
15894686|NCT03691441|Procedure|Resection|Definitive surgery should generally be performed within 2 weeks, but not more than 4 weeks after randomization. The appropriately indicated neck dissection(s) may be performed either prior to, during the same session, or within 2 weeks after the resection of the primary tumor, but not later than 4 weeks following randomization. The primary tumor is to be resected with clear margins (R0) and en bloc in all cases. Frozen section assessment must be routinely and readily available.
15894687|NCT03691441|Radiation|Radiotherapy|6-7 weeks standard risk-adapted adjuvant radiotherapy 56-66 Gy, start within 6 weeks post-surgery Arm B: 6-7 weeks standard radiotherapy (IMRT-technique), start within 4 weeks after randomization, 70-72 Gy, SIB possible
15894688|NCT03691441|Drug|Chemotherapy|The investigational medicinal product (IMP) are the chemotherapeutical drugs Cisplatin, Mitomycin C and 5-FU. According to local routine, chemotherapy protocols as listed in study protocol should be used.
15894689|NCT03691441|Procedure|Salvage neck dissection|+/- Salvage neck dissection 12±2 weeks after treatment
15894690|NCT03691428|Behavioral|Wish Outcome Obstacle Plan|"1. Wish or goal: A wish (e.g. responding calmly when the partner asks a question repeatedly). 2. Outcome: The most positive outcome of realizing the wish or goal (e.g. both partners feel respected and happy). Then the participant vividly imagines the outcome. 3. Obstacle: The most critical internal, controllable, obstacle (e.g., feeling impatient). Then the participant vividly imagines the internal obstacle occurring. 4. Plan: The participant answers the following question: What action can I take or what thought can I think to overcome the obstacle (e.g., take a deep breath, take my partner's perspective, and answer the question calmly); then he or she forms an if [specified obstacle - when I feel impatient], then I will [specified action or thought to overcome obstacle - take a deep breath, take my partner's perspective, and answer the question calmly] plan."
15894691|NCT03691415|Drug|BELKYRA Inj.|Patient will be administered BELKYRA Inj. at least once and the interval between treatments not less than 1 month apart.
15895443|NCT03685565|Procedure|Dermabond and steristrips|Laceration repaired with Dermabond with underlying steristrips
15894694|NCT03691376|Biological|Aldesleukin|Given SC
15894695|NCT03691376|Biological|Autologous NY-ESO-1-specific CD8-positive T Lymphocytes|Given IV
15894696|NCT03691376|Other|Cellular Therapy|Given autologous NY-ESO-1 CD4-TCR CD34+ HSC IV
15894697|NCT03691376|Drug|Melphalan|Given IV
15894698|NCT03691363|Behavioral|M-STEP|Youth will be assessed using actigraphy at baseline, and will then be asked to exercise for 1) a duration of 10 minutes > MVPA at baseline with 2) HR>120 while being monitored by a Fitbit. Youth will be asked to exercise daily, and intensity and duration will be increased every few days for a goal of 60 minutes per day at a HR>140 (low end of MVPA). The intervention will be 6 weeks in duration.
15894699|NCT03691350|Procedure|Bronchoscopy with Bronchoalveolar Lavage|Undergo bronchoscopy with bronchoalveolar lavage
15894700|NCT03691350|Drug|Cigarette|Smoke usual brand
15894701|NCT03691350|Other|Electronic Cigarette|Smoke SREC with nicotine
15894702|NCT03691350|Other|Electronic Cigarette|Smoke SREC without nictoine
15894703|NCT03691350|Other|Laboratory Biomarker Analysis|Correlative studies
15894704|NCT03691350|Drug|Nicotine Replacement|Receive NRT comprising patch, gum, or lozenge
15894705|NCT03691350|Other|Questionnaire Administration|Ancillary studies
15894706|NCT03691337|Drug|Marcaine 0.25 % Injectable Solution|Fascia iliaca block with volume 0.11 mL x subject height
15894707|NCT03691337|Drug|Marcaine 0.25 % Injectable Solution|Fascia iliaca block with volume 0.22 mL x subject height
15894708|NCT03691337|Drug|Sodium chloride|Fascia iliaca block with volume 0.11 mL x subject height
15894709|NCT03691324|Other|Inhalation technique training and discharge service|Patient drug counselling one-to-one, focusing on inhalation drugs and technique
15894710|NCT03691311|Drug|Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]|Two injections on days 1 and 8 previous to surgery breast cancer excision
15894711|NCT03691298|Device|Suturefix Ultra and Suturefix Curved Suture Anchor|Fixation device intended to provide secure fixation of soft tissue to bone to stabilize hip
15894712|NCT03691285|Procedure|Mandibular Overdenture|Placement of 1 or 2 implants in the anterior region of the edentulous mandible.
15894713|NCT03691272|Device|rTMS - Real Air Film Coil|70% resting motor threshold amplitude; Frequency 10 Hz; 10 trains of 60 pulses/train (total of 600 pulses); Inter-train interval 45s.
15894714|NCT03691272|Device|rTMS - Sham Coil|A sham coil will be applied to the scalp after the resting motor threshold is determined. Patients will be able to hear the sound and feel the vibration of sham coil, but will not experience any effective stimulation.
15894715|NCT03691259|Other|Ballet Classes|Ballet classes will consist of learn the basic positions and combinations used in ballet, including: Plié, Tendu, Degagé, Rond de Jambe, Frappé, Chassé, Sauté, Pas de Bourrée, Glissade, and Révérance. Additional ballet movements and patterns may be employed as well.
15894716|NCT03691233|Drug|Clinical audit on diagnosis and management of neonatal shock|intervenous
15894717|NCT03691220|Behavioral|Telemetric Intervention|Calls, scripted by a manual; the frequency of the calls varies with patient's MLVI status and preferences.
15894718|NCT03691207|Drug|AL101|"AL101 is a small-molecule that inhibits gamma secretase, an enzyme which plays a key role in the activation of the Notch signaling pathway by releasing the Notch intracellular domain (NICD) of all four Notch receptors from the membrane.
~In patients with aberrant Notch signaling, AL101 may inhibit Notch signaling and potentially impede tumor growth.The drug is administered intravenously"
15894719|NCT03691194|Dietary Supplement|fresh orange juice|The fresh oranges will be bought from Sysco. They will be squeezed at the kitchen of School of Allied Health Professional with a juicer. They will either be squeezed the night before or on the same day. The juice will not be treated with additional preservatives or sugar. The brand of the juicer is Kitchen Aid. Eight ounces of fresh orange juice needs approximately two and half oranges. They will be put into 32 oz water bottles that were bought from Sysco, and then store them in the refrigerator. They will be given to the subjects every three or four days.
15894720|NCT03691194|Dietary Supplement|concentrated orange juice|The concentrated orange juice will be bought from Sysco then reconstituted. One part of concentrated orange juice needs four parts of water to reconstitute. Then, it will be measured and the reconstituted orange juice will be put into 32 oz water bottles that we bought from Sysco. They will be stored in the refrigerator. The subjects will need to get the reconstituted orange juice every three or four days.
15894721|NCT03691181|Device|Ventilation|monitoring with the use of the Life2000 Ventilation System for a period of six months
15894722|NCT03691155|Other|The Crohn's Diet|All recruited participants will be educated on the Crohn's Diet and instructed to adhere to the study diet for 14 days.
15894723|NCT03691142|Other|Questionnaire|Interview of women with Hereditary Haemorrhagic Telangiectasia (HHT) during a consultation in the Reference Center for HHT or through a phone questionnaire about obstetric history, complications during pregnancy, delivery and neonatal outcomes.
15894724|NCT03691129|Behavioral|Participation in the elderly yoga program|Yoga participant groups will practice elderly yoga for four months.
15894725|NCT03691116|Behavioral|Digital Health Profile|Screening, health check-up and automatic feedback in the areas tobacco, alcohol, exercise and diet, used on a National digital platform (Stöd och Behandlingsplattformen, SoB)
15894726|NCT03691116|Behavioral|Treatment as usual|Ordinary psychological assessment and counseling.
15894727|NCT03691090|Drug|SHR-1210|SHR-1210 200mg
15894728|NCT03691090|Drug|Placebo|Placebo
15894729|NCT03691090|Drug|paclitaxel|paclitaxel 175mg/m2
15894730|NCT03691090|Drug|cisplatin|cisplatin 75mg/m2
15894731|NCT03691077|Drug|Ocrelizumab|The first dose of ocrelizumab will be administered as two 300-mg IV infusions (600 mg total) in 250 mL 0.9% sodium chloride each separated by 14 days (i.e., Days 1 and 15), followed by one 600-mg IV infusion in 500 mL 0.9% sodium chloride every subsequent doses (i.e., every 24 weeks) for 72 weeks.
15894732|NCT03691064|Drug|LUTATHERA|Labeled dosing regimen: 7.4 gigaBecquerel (GBq) (200 milliCurie [mCi]) every 8 weeks for a total of 4 doses.
15894734|NCT03691038|Drug|Pregabalin 75mg bid|Through the study period, Incremental protocol follows the conventional dose regimen starting pregabaline 75mg bid.
15894735|NCT03691038|Drug|Pregabalin 25mg, 50mg|Through the study period, Incremental protocol follows the new dose regimen starting pregabalin 25mg, 50mg
15894736|NCT03691012|Diagnostic Test|Circulating tumour DNA testing|Circulating tumour DNA testing
15894737|NCT03690999|Dietary Supplement|Placebo|Placebo product
15894738|NCT03690999|Dietary Supplement|Prebiotic supplement|Prebiotic supplement
15894739|NCT03690986|Biological|VX15/2503|Given IV
15894740|NCT03690986|Biological|Ipilimumab|Given IV
15894741|NCT03690986|Biological|Nivolumab|Given IV
15894742|NCT03690973|Drug|Alveolar socket preservation with graft and flap surgery|Alveolar socket preservation with xenogenic bone graft and flap surgery
15894743|NCT03690973|Device|Immediate implant placement with bone using flapless surgery|Immediate implant placement with xenogenic bone graft using flapless surgery
15894744|NCT03690973|Device|Immediate implant placement with bone using flap surgery|Immediate implant placement with xenogenic bone graft using flap surgery
15894745|NCT03690973|Drug|Alveolar socket preservation with graft and flapless surgery|Alveolar socket preservation with xenogenic bone graft and flapless surgery
15894746|NCT03690960|Procedure|electrospun TAP nanofibers|electrospun TAP loaded nanofibers containing modified triple antibiotic paste of clindamycin , ciprofloxacin and metronidazole by electrospinning process will be placed in the root canals. The access cavity will be sealed with temporary filling material
15894747|NCT03690960|Procedure|modified TAP paste|modified TAP paste will be prepared by mixing equal proportions of CIP, MET and CLIN then placed inside the root canal, access cavity will be sealed with temporary filling
15894748|NCT03690947|Drug|Intravitreal Ranibizumab|All subjections received 3 initial Ranibizumab injections
15894749|NCT03690947|Procedure|Micropulse Laser|After 3 initial Ranibizumab injections, Micropulse Laser will be done as needed each month if macular edema persists
15894750|NCT03690947|Drug|Intravitreal Ranibizumab as needed|After 3 initial Ranibizumab injections, Ranibizumab will be injected as needed till BCVA reaches stabilization
15894751|NCT03690934|Procedure|Fistula-tract laser closure (FiLAC™)|The procedure was performed with a diode laser platform emitting laser energy of 15 W at a wavelength of 1470 nm by means of a radial ﬁber. For obliteration, the ﬁstula track is treated with a continuous slow retraction of the laser ﬁbre withdrawn at a rate of approximately 1 cm per 2-3s.
15894752|NCT03690934|Procedure|Monopolar coagulation of fistulous tract|The procedure was performed with a monopolar coagulator platform emitting monopolar coagulation. For obliteration, the ﬁstula track is treated with a continuous slow retraction of the monopolar energy with suturing the internal fistulas opening.
15894753|NCT03690921|Drug|Cisplatin|Given IV
15894754|NCT03690921|Drug|Fluorouracil|Given IV
15894755|NCT03690921|Radiation|Linear Energy Transfer-Optimized Intensity Modulated Proton Therapy|Undergo LET-IMPT
15894756|NCT03690921|Procedure|Quality-of-Life Assessment|Ancillary studies
15894757|NCT03690921|Other|Questionnaire Administration|Ancillary studies
15894758|NCT03690908|Other|no intervention (descriptive study)|no intervention (descriptive study)
15894759|NCT03690895|Other|Retrospective survival analysis|Kaplan-Meier model
15894760|NCT03690882|Other|systematic review of medical imaging|
15894761|NCT03690869|Drug|REGN2810 (monotherapy)|To be administered intravenously as monotherapy in Phase 1
15894762|NCT03690869|Drug|REGN2810 (maintenance)|To be administered intravenously in combination with radiation and then used as maintenance therapy
15894763|NCT03690869|Radiation|Conventional or hypofractionated|Combined with REGN2810 IV administration
15894764|NCT03690869|Radiation|Re-irradiation|Combined with REGN2810 IV administration
15894765|NCT03690856|Other|inflammatory, neuropsychological and neuroimaging assessment|"Acts add by research:
~pregnancy test; Centralized: IL1, IL6, TNF
~Neuropsychologic tests at M6 and M24:
~Edinburgh Ladder Lateral Test, Direct and Inverse Verbal Empan, Matrices (WAIS IV), Similarities (WAIS IV), Vertebral fluences, STROOP test, TMT test (Delis Kaplan), WCST test, CPT III, WAIS IV (code)"
15894766|NCT03690843|Other|Test Battery|All toddlers (DCD children + TD children) included in the study will be tested at three points in time, that is at the age of 3y, 4y and 5y with an extensive test battery. Questionnaires will be filled in by parents and teachers. Children will be tested using different instruments.
15894767|NCT03690830|Other|metabolomics analysis|collect blood samples and endometrial cells
15894768|NCT03690817|Behavioral|RBANS-H, virtual Morris Water Maze|Cognitive tasks for respectively: general cognition and spatial cognition
15894769|NCT03690804|Device|Evaluation of Autonomic nervous system indices|The ECG signal, respiration rate, SpO2 and NIPΣ or ANI are recorded simultaneously on a computer with a capture card. The other indices of HRV will be analyzed offline: SDNN (standard deviation of all NN intervals), pNN30 (NN30 count divided by the total number of all NN intervals), pNN50 (NN50 count divided by the total number of all NN intervals), RMSSD (quadratic mean of successive R-R intervals), SD1 (standard deviation), SD2 (standard deviation), LF (low frequencies), HF (high frequencies), VLF (very low frequencies), SDANN (standard deviation of the averages of NN intervals in all 5 min segments of the entire recording), ratio LF/ HF, Ptot, Poincaré plot (plot points corresponding to each R-R space of a record).
15894770|NCT03690791|Drug|MediCabilis CBD Oil|50 mg of CBD: <2mg of THC in one ml. The cannabis oil consists of CBD extract in MCT oil.
15894771|NCT03690791|Drug|Placebo Oil|Placebo will contain only hemp seed oil.
15894772|NCT03690778|Drug|"Metformin and Rosuvastatin seperately"|"administration of Metformin and Rosuvastatin seperately"
15894773|NCT03690778|Drug|JLP-1310|administration of JLP-1310
15894774|NCT03690765|Drug|Duphaston® (Dydrogesterone)|No intervention. Duphaston® is prescribed according local labelling for treatment of endometriosis 10 mg 2-3 times a day from the 5th to the 25th day of the menstrual period cycle. Description of routine practice only.
15894775|NCT03690765|Drug|Duphaston® (Dydrogesterone)|No intervention. Duphaston® is prescribed according local labelling for treatment of endometriosis 10 mg 2-3 times a day continuously. Description of routine practice only.
15894841|NCT03690284|Device|VivaSight Double Lumen Tube|Patient will be intubated with the VivaSight double lumen endotracheal tube with an integrated camera for single lung ventilation during thoracic surgery
15894776|NCT03690752|Device|unweighting using Alter-G Anti-Gravity Treadmill|The unweighted group (experimental) is allowed to self-select a comfortable unweighting using the weight control feature on the Alter-G Anti-Gravity Treadmill. Both groups use the same Alter-G Anti-Gravity Treadmill and both groups are about to self-select speed, incline, and duration.
15894777|NCT03690752|Device|normal weight using Alter-G Anti-Gravity Treadmill|The weighted (control) group will walk at 100% their body weight using the Alter-G Anti-Gravity Treadmill. Both groups use the same Alter-G Anti-Gravity Treadmill and both groups are about to self-select speed, incline, and duration.
15894778|NCT03690739|Drug|Carboplatin|Administration according to investigator's discretion
15894779|NCT03690739|Drug|Gemcitabine|Administration according to investigator's discretion
15894780|NCT03690739|Drug|Bevacizumab|Administration according to investigator's discretion
15894781|NCT03690739|Drug|PLD|Administration according to investigator's discretion
15894782|NCT03690739|Drug|Paclitaxel|Administration according to investigator's discretion
15894783|NCT03690739|Drug|PLD|Administration 30 mg/m² q21
15894784|NCT03690739|Drug|Trabectedin|Administration 1.1 mg/m² q21
15894785|NCT03690739|Drug|Cisplatin|Administration according to investigator's discretion
15894786|NCT03690726|Device|repetitive transcranial magnetic stimulation|Repetitive transcranial magnetic stimulation of the leg motor cortex, in combination with resistance training
15894787|NCT03690726|Other|Sham stimulation|Imitated magnetic stimulation: An active coil will be activated under the subject's head, firing down into the mattress, while an inactive coil will be held over the scalp
15894788|NCT03690713|Diagnostic Test|Fractional flow reserve, coronary flow reserve, and index of microcirculatory resistance|The pressure sensor was positioned at the distal segment of a target vessel, and intracoronary nitrate was administered before each physiologic measurement. To derive resting mean transit time (Tmn), a thermodilution curve was obtained by using 3 injections (3-4 mL each) of room-temperature saline. Hyperemic proximal aortic pressure (Pa), distal arterial pressure (Pd), and hyperemic Tmn were measured during sustained hyperemia. CFR was calculated as resting Tmn/hyperemic Tmn. FFR was calculated as the lowest average of 3 consecutive beats during hyperemia. The uncorrected IMR was calculated by Pd × Tmn during hyperaemia. All IMR values were corrected by Yong's formula (Pa × Tmn × ([1.35 × Pd/Pa] - 0.32).
15894789|NCT03690700|Other|BFRE|BFR will be performed in the aBFRE group by use of pneumatic occlusion cuffs placed proximally on the thigh close to the inguinal fold, using an occlusion pressure corresponding to 40 % of seated arterial occlusion pressure (AOP). The individual AOP will be documented at baseline using doppler ultrasound (Siemens ACUSON S2000TM). Previous studies have shown that this pressure level can promote significant muscle adaptations to a similar degree and are associated with significantly less discomfort than higher occlusion pressures. The occlusion pressure of the participants in sham BFRE group will be 10mmHg.
15894790|NCT03690687|Procedure|Primary anastomosis|
15894791|NCT03690687|Procedure|Delayed anastomosis|
15894792|NCT03690687|Procedure|Enterostomy|
15894793|NCT03690674|Behavioral|Lifestyle Enhancement for ADHD Program|The LEAP intervention consists of 3 components: 1) an enhanced 8-week, group-based BMT curriculum, 2) parent and child use of the Garmin daily activity tracker accompanied by personalized goal setting, and 3) parent participation in a private Facebook group to encourage PA goal achievement and promote social support and positive parenting.
15894794|NCT03690661|Behavioral|Intervention Video Game|"The intervention game employs evidence-based serious game mechanics (e.g., storylines, long-term goals, scaling difficulty) to design a learning environment that maximizes opportunities for adolescents with ASD to discover the functional utility of eye gaze cues."
15894795|NCT03690661|Behavioral|Placebo Control Game|The placebo game will have all the elements of the serious game mechanics of the intervention game (narrative storylines, long-term goals, scaling difficulty), but will not provide the learning opportunities regarding eye gaze cues.
15894796|NCT03690648|Other|Quality of life survey|Administration of scales: SF-12v2, EQ-5D, QCD, DN4, EIMIR, MFIS-5 et EHAD
15894797|NCT03690648|Genetic|Saliva collection|Collection of 20 ml of saliva with a kit of saliva collection
15894798|NCT03690648|Genetic|Blood collection|Collection of 20 ml of blood with kit of blood collection
15894799|NCT03690635|Procedure|VISTA (vestibular incision subperiosteal tunnel acess)|"A vertical incision will be made on the mucous membrane and the periosteum with a scalpel. The incision will be 8-10mm long, beginning from the mobile mucosa and reaching the apical end of the keratinized gingiva.
~A small subperiosteal elevator will be inserted through the incision and is used to free the subperiosteal tunnel flap. The flap includes the tissues of the mobile and immobile mucosa in the area of the affected teeth and about 1 mm distally and medially from them.
~Subperiosteal tunnel will be extended interproximally under each papilla as far as the embrasure space permits, without making any surface incisions through the papilla.
~Tunneling instruments will be used through the vertical incision to free the mucosa and the periosteum around the teeth affected by the gingival recession. This is continues at the base of the gingival papillae without affecting their integrity."
15894800|NCT03690622|Drug|Dexmedetomidine|Instillation of eyedrops
15894801|NCT03690622|Drug|Balanced salt solution|instillation of eyedrop
15894802|NCT03690609|Dietary Supplement|CytoQuel|3 capsules daily.
15894803|NCT03690609|Dietary Supplement|CytoQuel|2 capsules twice daily.
15894804|NCT03690596|Other|NRT + QuitBuddy|QuitBuddy treatment app and 1 month supply of 4 mg nicotine lozenge
15894805|NCT03690596|Other|NRT + QuitBuddy-Recall|QuitBuddy-Recall treatment app and 1 month supply of 4 mg nicotine lozenge
15894806|NCT03690596|Other|Treatment as Usual|1 month supply of 4 mg nicotine lozenge
15894807|NCT03690583|Drug|Zinc sulfate|Zinc sulfate 10 mg for children younger than 1 year old, 20 mg for children older than 1 year old, will be diluted in 1 ml of sterile water and administered orally every day in the morning during hospitalization
15894808|NCT03690583|Other|Glucose|The placebo group will receive glucose diluted in 1 ml of sterile water orally every day during hospitalization
15894912|NCT03689699|Drug|Nivolumab|A dose of 480mg every 4 weeks as a 30 minute IV infusion for 6 doses has been selected for this study. 6 total doses.
15894913|NCT03689699|Drug|Degarelix|Standard treatment at a dose of 240mg subcutaneously (SQ) as a loading dose followed by 80mg SQ every 4 weeks for 4 doses.
15895444|NCT03685565|Procedure|Dermabond|Laceration repaired with Dermabond
15911425|NCT03563144|Drug|Avelumab|Avelumab
15894809|NCT03690557|Behavioral|IncentaHealth|IncentaHealth is a comprehensive, behavioral weight management program designed to help individuals initiate and maintain weight loss. Individuals participate in the IncentaHealth program from their homes, receive program information electronically through daily emails and through a smartphone app for the duration of the study, and have the option to receive text messages and speak with health coaches over the telephone. Participants in this study will be enrolled in the IncentaHealth program for 12 months, and will engage with health coaching, tracking of body weight, and are provided a number of resources for healthy living throughout the 12 months.
15894810|NCT03690544|Drug|Apremilast 30mg|Apremilast is an oral small-molecule inhibitor of phosphodiesterase (PDE) 4 that works intracellularly to modulate a network of pro-inflammatory and anti-inflammatory mediators. PDE 4 is a cyclic adenosine monophosphate (cAMP)-specific PDE and the dominant PDE in inflammatory cells. PDE4 inhibition elevates intracellular cAMP levels, which in turn down-regulates the inflammatory response by modulating the expression of TNF-alfa, IL-23, IL-17 and other inflammatory cytokines. Cyclic AMP also modulates levels of anti-inflammatory cytokines such as IL-10. Apremilast has immunomodulatory activity and, therefore, has the potential to be effective in the treatment of RAS.
15894811|NCT03690531|Device|Take-Pause virtual reality|Take-Pause virtual reality simulation lasting 3 minutes shown through a virtual reality goggle, headset and iPhone.
15894812|NCT03690531|Device|Passive Distraction|Standard or passive distraction technique, lasting 5 minutes.
15894813|NCT03690518|Other|Cardiac rehabilitation|Educational/Counseling/Training : Rehabilitation, , cardiovascular rehabilitation in congenital heart disease
15894814|NCT03690505|Behavioral|Interviews|informant-based questionnaire semi-structured individual interviews focus group interviews
15894815|NCT03690492|Other|The Box 2.0|Patients in the intervention arm will receive a Box with several devices that is hypothesized to allow for better and earlier detection of complications after cardiac surgery.
15894816|NCT03690479|Device|Florida Probe Straight Tip Probe|Twenty (20) consecutive adult patients with a diagnosis of periodontal disease (varying degrees, from slight to severe) will be selected to undergo full-mouth periodontal probing. . One half (upper or lower jaw) of the mouth will be probed using the current, standard probe tip.
15894817|NCT03690479|Device|Ball Tip Probe|Twenty (20) consecutive patients meeting the inclusion criteria will be selected to undergo full-mouth periodontal probing. The opposing jaw will be probed using the new trial tip. At a second visit, prior to treatment, the mouth will be probed once again, alternating the jaws from the first visit.
15894818|NCT03690466|Device|Study device treatment|The ultrasound portable device comprises a tabletop control unit and a transducer connected to the control unit by a cord.
15894819|NCT03690466|Device|Sham device treatment|A similar device as used for the study device treatment will be used, except that no energy will be delivered to the spleen.
15894820|NCT03690453|Drug|Ivermectin|single dose of Ivermectin
15894821|NCT03690427|Other|Traditional hookah smoking|Charcoal-heated hookah smoking
15894822|NCT03690427|Other|Electronic hookah inhalation|Electronic hookah bowl
15894823|NCT03690414|Drug|Experimental BHVI2|Experimental BHVI2 eye drops
15894824|NCT03690414|Drug|Atropine sulfate 0.02% eye drops|Atropine eye drops
15894825|NCT03690414|Combination Product|Combination eye drops|Combination eye drops with experimental BHVI2 plus 0.02% atropine
15894826|NCT03690401|Device|SOZO Device|SOZO device will estimate fluid status, total body composition, metabolic report, skeletal muscle mass, phase angle, body mass index, weight, and hydration index analysis. Participants will be asked to fast for at least 8 hours before each visit, but water may be consumed to ensure they are well-hydrated. Participants will be asked to provide a urine sample at each visit and to report the color of your urine to the staff so they can determine how well hydrated the participants are. If not hydrated to the extent needed, participants will be asked to drink water and repeat the urine sample again after 30 minutes. A total of 5 SOZO measurements will be recorded over 12 weeks.
15894827|NCT03690401|Device|DEXA Scan|DEXA scan bone density reading with hip and spine measurements as well as a whole body composition scan will be performed. Where DEXA cannot be collected on the same day as other study assessments, Weight/BMI, Urine Color, and SOZO should all be collected (or repeated if already done) to coincide with the DEXA scan if SOZO is available at DEXA location.
15894828|NCT03690388|Drug|Cabozantinib|Tablets containing 60-mg or 20-mg cabozantinib once daily orally.
15894829|NCT03690388|Drug|Placebo|Tablets containing placebo equivalent of 60-mg or 20-mg cabozantinib once daily orally.
15894830|NCT03690375|Device|Broad Band Light (BBL)|Sciton's BBL treatment using a new protocol that utilizes a 590nm, 560nm, and skintyte filter
15894831|NCT03690362|Drug|VNRX-5133 and VNRX-5022|intravenous infusion
15894832|NCT03690349|Other|Skin test|Demographic data review, Disease severity evaluation, Treatment evaluation and Skin prick test for 16 common aeroallergens
15894833|NCT03690336|Drug|Nonacog beta pegol|Treatment with commercially available nonacog beta pegol according to routine clinical practice at the discretion of the treating physician.
15894834|NCT03690323|Procedure|Radiofrequency ablation (RFA)|RFA involves the implantation of electrodes directly into the tumor, with the use of intra-operative ultrasound. The electrodes produce a high frequency alternating current, which leads to frictional heating and thus tissue destruction by thermal coagulation and protein denaturation.
15894835|NCT03690323|Drug|FOLFIRINOX|Oxaliplatin 85mg/m2 given as 2-hour IV infusion, followed by leucovorin 400mg/m2 given as 2-hour IV infusion with addition of irinotecan 180mg/m2 given as 90-minute IV infusion. Followed by fluorouracil 400mg/m2 IV bolus, followed by continuous IV infusion of 2400mg/m2 during 46-hour. Every 2 weeks.
15894836|NCT03690323|Drug|Nab-paclitaxel plus Gemcitabine|Nab-paclitaxel 125mg/m2 given as 30-40-minute IV infusion, followed by gemcitabine 1000mg/m2 IV infusion. On day 1, 8 and 15 every 4 weeks.
15894837|NCT03690323|Drug|Gemcitabine|Gemcitabine 1000mg/m2 given as 30-minute IV infusion. On day 1, 8 and 15 every 4 weeks.
15894838|NCT03690310|Biological|Anti-CD19 CAR NK Cells|Anti-CD19 CAR NK Cells injection
15894839|NCT03690297|Device|Linked Color Imaging|Use of narrow band imaging with LCI for colon inspection during both insertion and withdrawal phase of colonoscopy
15894840|NCT03690284|Device|Conventional Double Lumen Tube|Patient will be intubated with Mallinckrodt Double Lumen endotracheal tube for single lung ventilation during thoracic surgery
15895793|NCT03682718|Drug|Misoprostol|Misoprstol inserted vaginally for induction of labor
15894842|NCT03690258|Device|Variable load exercise|This study is being conducted to determine whether variable load training approach (nHANCE™ squat - more data available at http://nhance.se/) is an effective countermeasure to attenuate for rapid declines in muscle power, function, that typically originate from aging and muscle disuse. Since age-related decline is accelerated already after short bouts of physical inactivity, with small recovery potential, any attempt to counteract age-related and disuse-related decline have high clinical significance. Based on the findings, safety guidelines and protocols could be developed aimed at reducing health risks in seniors. Importantly, in case present hypotheses are confirmed, this may offer important information to the healthcare system.
15894843|NCT03690245|Procedure|Initiation of Resuscitation While Attached to the Cord|Infants will receive active resuscitative care according to the Neonatal Resuscitation Program (NRP) guidelines including warmth, dry, suctioning, oxygen, and respiratory support using iNSPiRE platform for 120 seconds while attached to the cord.
15894844|NCT03690232|Drug|glucose water|3 sessions of 6cc 25% glucose injection with a 2-week interval
15894845|NCT03690232|Drug|hyaluronic aicd|intra-articular HA ((Hyruan Plus® , average MW 3000 kD; LG Life Sciences Ltd, Korea)) for sessions with a 1-week interval between each treatment
15894846|NCT03690219|Other|no intervention|no intervention
15894849|NCT03690193|Behavioral|Ketogenic Diet|All participants will be assigned to the 3-month 1:1 ketogenic diet intervention (approximately 70% fat, <10% carbohydrate, and 20% protein).
15894850|NCT03690180|Diagnostic Test|serum magnesium|assessment of serum magnesium in all patients
15894851|NCT03690167|Other|Concentrated Growth Factor (CGF)|CGF application (9 ml venous blood will harvested from the participants in the CGF group and centrifuged according to the protocol for CGF)
15894852|NCT03690167|Other|Advanced Platelet Rich Fibrin (A-PRF)|A-PRF application (9 ml venous blood will harvested from the participants in the CGF group and centrifuged according to the protocol for A-PRF)
15894853|NCT03690167|Other|Control|Nothing applied after extraction
15894854|NCT03690154|Drug|FN-1501|Eligible patients will receive a single intravenous infusion of study drug on Days 1, 3, 5, 8, 10, and 12 of a 21-day cycle. Dosing will begin at 2.5 mg once per day on the assigned days. Dose escalation will use the traditional 3+3 design and follow a modified Fibonacci sequence until MTD is reached. Increments of 33% in the dose of FN-1501 will be undertaken after reaching 30 mg/day. At least 3 patients will be enrolled in each cohort. Administration of FN-1501 will be continued until disease progression, intolerable toxicity, withdrawal of consent, or termination according to the Principal Investigator's judgment or at the sponsor's request.
15894855|NCT03690141|Drug|tomivosertib (eFT508)|This Phase 2 study examines the efficacy, safety, tolerability, and PK of tomivosertib (eFT508) in advanced CRPC patients who have documented PSA progression on treatment with apalutamide and/or abiraterone and/or enzalutamide and for whom no suitable curative therapy exists.
15894856|NCT03690128|Behavioral|I-EWS with incorporated clinical assessment (Trigger Tool)|In relation to systematic measurement of vital parameters the nursing staff will perform an individual clinical assessment of the patient and adjust the I-EWS score accordingly.
15894857|NCT03690128|Behavioral|Standard EWS - Control (Trigger Tool)|Standard EWS - Based on principles of National Early Warning Score (NEWS)
15894858|NCT03690115|Drug|Ponatinib 30 MG|Administration of ponatinib after allo-SCT transplant in FLT3-ITD AML patient
15894859|NCT03690102|Other|T-CPR|Participants receive telephone instructions in cardiopulmonary resuscitation (T-CPR) from the Emergency Medical Services in Copenhagen during the cardiac arrest scenario test.
15894860|NCT03690102|Other|ERC standardized BLS course|Participants will receive and complete the standardized course in basic life support (BLS) from European Resuscitation Council (ERC).
15894861|NCT03690089|Drug|Atropine Sulfate|Atropine sulfate 0.01% eye drops which consist of 10mls of a clear colourless solution of atropine sulfate 0.01% w/v and benzalkonium chloride 0.01% w/v in sterile water.
15894862|NCT03690089|Other|Placebo|Placebo eye drops which consist of 10mls of a clear colourless solution of benzalkonium chloride 0.01% w/v in sterile water.
15894863|NCT03690076|Other|Endocarditis|Comparison : Endocarditis vs. control
15894864|NCT03690076|Other|Obese vs. control|Comparisons : Obese vs. control
15894865|NCT03690063|Other|Follow up|Follow up of treatment, behavior, co-morbidity
15894866|NCT03690050|Procedure|Diode 577 nm subthreshold micropulse laser|On the day the laser procedure is going to be performed, participants will be randomised 1:1 to receive DSML or standard laser using an automated randomisation system. The DSML surgery will be performed by an Ophthamologist
15894867|NCT03690050|Procedure|Standard threshold laser (532 nm laser)|On the day the laser procedure is going to be performed, participants will be randomised 1:1 to receive DSML or standard laser using an automated randomisation system. The standard laser surgery will be performed by an Ophthamologist
15894868|NCT03690037|Drug|Tranexamic Acid 100 MG/ML|Tranexamic Acid: 100 MG/ML Solution for injection
15894869|NCT03690037|Drug|Tranexamic Acid 500 MG|Tranexamic Acid: Tranexamic Acid 500mg Tablets
15894870|NCT03690011|Genetic|CD7.CAR/28zeta CAR T cells|"Three dose levels will be evaluated:
~Dose level one: 1×10^7 cells/m^2
~Dose level two: 3×10^7 cells/m^2
~Dose level three: 1×10^8 cells/m^2"
15894871|NCT03690011|Drug|Fludarabine|Patients will receive 3 daily doses of fludarabine (30 mg/m^2) to induce lymphopenia, finishing at least 24 hours before T cell infusion.
15894872|NCT03690011|Drug|Cyclophosphamide|Patients will receive 3 daily doses of cyclophosphamide (500 mg/m^2/day) to induce lymphopenia, finishing at least 24 hours before T cell infusion.
15894873|NCT03689998|Device|immediate implant placement|immediate implant placement in freshly extraction socket
15894874|NCT03689998|Drug|Melatonin|topical application of melatonin
15894875|NCT03689985|Device|smART Feeding Tube System|Replacing generic feeding tube with smART Feeding Tube System.
15894876|NCT03689972|Drug|Natalizumab|Natalizumab 300 mg SC injection or IV infusion.
15894914|NCT03689699|Drug|BMS-986253|BMS-986253 (also referred to as anti-IL8 mAb or HuMax IL8) is a fully human-sequence IgG1κ monoclonal antibody (mAb) directed against human interleukin-8 (IL-8). Subjects will be treated with an intravenous (IV) flat dose of 2400mg every 2 weeks.
15895794|NCT03682705|Drug|Elsubrutinib|Elsubrutinib capsule will be administered orally.
15894877|NCT03689959|Procedure|Eight plate hemiepiphysiodesis|Patient is positioned in a classic supine position. Under fluoroscopic guidance and tourniquet hemostasis, the distal femoral physis is identified. Two 3-cm incisions are made, one on either side of the patella, centred at the level of the physis. The capsule and synovium are opened to visualize the sulcus and place the plates just outside the articular portion of the joint surface, medially and laterally. Care is taken not to damage the periosteum and a needle is inserted into the physis. The 8-plate, which has a central hole, is slipped over the needle and screws inserted. After wound closure, a soft dressing is used, and the patient is allowed to ambulate as tolerated.
15894878|NCT03689946|Drug|Evolocumab|"Evolocumab: In patients without homozygous familial hypercholesterolemia (FH), evolocumab will be self-injected as follows: 140mg every 2 weeks or 420mg once a month subcutaneously.
~Patients with homozygous FH will be instructed to administer 420mg subcutaneously once a month by giving 3 injections consecutively within 30 minutes using the single-use prefilled autoinjector."
15894879|NCT03689946|Diagnostic Test|18F-NaF PET|18F-NaF PET: Baseline (pre-treatment) and follow-up dual cardiac and respiratory-gated PET- imaging of the thoracic aorta. Dose of 250 MBq 18F-NaF intravenously.
15894880|NCT03689946|Diagnostic Test|CCTA|CCTA: Baseline (pre-treatment) and follow-up CCTA. Bolus injection of 80-100 ml contrast (Omnipaque or Visipaque). Possible beta blocker(metoprolol)administered to achieve a target heart ≤70 beats/min (bpm) and/or 0.4 or 0.8 mg of sublingual nitroglycerin administered, if medical safe.
15894881|NCT03689933|Device|Root analog implant|a custom made root analogue implant made from milled titanium
15894883|NCT03689907|Other|Chimerism Evaluation|Blood collection for chimerism evaluation will be performed on days +14/15-post transplant and +30-post transplant for each study participant.
15894884|NCT03689894|Drug|Ibrutinib|"Subjects will receive oral (PO) Ibrutinib 140 mg once daily with Rituximab 375 mg per meter squared IV weekly x4 (with pre-medications and infusion procedure as per standard protocol) Rituximab Pre-medications:Acetaminophen 650 mg PO; Diphenhydramine 25 mg PO/IV; Dexamethasone 20 mg IV.
~If no adverse events >Grade 3+ are noted after 1 week, the Ibrutinib dose schedule will be increased to 280 mg daily. If no adverse events >Gr3+ are noted after an additional 1 week, the Ibrutinib dose will be increased to 420 mg daily."
15894885|NCT03689894|Drug|Rituximab|Subject will receive an intravenous infusion of 375mg per meter squared weekly for 4 weeks, which may be repeated 8 weeks after initial therapy if only a suboptimal response is achieved.
15894886|NCT03689881|Device|Tomosynthesis of SI joints|"All patients will undergo additional tomosynthesis performed per study protocol along with Xray and CT performed as part of standard imaging evaluation of sacroillitis.
~Tomosynthesis of SI joints will be performed on a digital Tomosynthesis system (PLATINUM dRF v2 DMS/APELEM), with a single acquisition followed by coronal image reconstruction."
15894887|NCT03689868|Behavioral|Virtual Reality|Virtual Reality headset with calming scenery
15894888|NCT03689855|Drug|Ramucirumab|Ramucirumab is an investigational agent for this trial and will be supplied by Lilly Oncology, free of charge to the patient.
15894889|NCT03689855|Drug|Atezolizumab|The initial dose will be administered over 60 minutes (+/- 15 minutes). If the first infusion is tolerated without infusion-associated events, the second infusion may be delivered over 30 minutes (+/- 10 minutes).
15894890|NCT03689855|Procedure|Peripheral blood draw|-Baseline and Cycle 2 Day 1
15894891|NCT03689855|Procedure|Biopsy|"If archival biopsy tissue not available, participant will undergo biopsy at baseline
~When feasible, a repeated tumor biopsy will be obtained between Cycles 2 and 3 after the scheduled CT scan."
15894892|NCT03689842|Procedure|Uterine transplantation|Uterine transplantation from living donor
15894893|NCT03689829|Drug|MOR106|The active pharmaceutical drug substance of MOR106 is a human immunoglobulin gamma-1 (IgG1) monoclonal antibody that binds with a high apparent affinity to human interleukin-17C (IL-17C).
15894894|NCT03689829|Drug|Placebo|Corresponding placebo s.c. injections.
15894895|NCT03689816|Procedure|sleeve gastrectomy|sleeve gastrectomy
15894896|NCT03689816|Procedure|gastric bypass|gastric bypass
15894897|NCT03689803|Procedure|sleeve gastrectomy|sleeve gastrectomy.
15894898|NCT03689803|Procedure|gastric bypass|gastric bypass
15894899|NCT03689790|Procedure|sleeve gastrectomy|sleeve gastrectomy
15894900|NCT03689790|Procedure|gastric bypass|gastric bypass
15894901|NCT03689777|Procedure|sleeve gastrectomy|sleeve gastrectomy
15894902|NCT03689777|Procedure|gastric bypass|gastric bypass
15894903|NCT03689764|Other|interactive video game-based exercise|Twenty-four patients were randomly allocated to two groups (12 participants per group). Group A received interactive video game-based exercise training for the first 6 weeks, with no intervention in the subsequent 6 weeks. Group B had no intervention for the first 6 weeks and then underwent interactive video game-based exercise training in the subsequent 6 weeks.
15894904|NCT03689764|Other|no intervention|Twenty-four patients were randomly assigned to two groups (12 participants per group). Group A received interactive video game-based exercise training for the first 6 weeks, with no intervention in the subsequent 6 weeks. Group B had no intervention for the first 6 weeks and then underwent interactive video game-based exercise training in the subsequent 6 weeks.
15894905|NCT03689751|Other|LSCS Video|LSCS video created depicting the patient journey for elective LSCS patients.
15894906|NCT03689751|Other|TVT/TOT Video|TVT/TOT video created depicting the patient journey for elective TVT/TOT patients.
15894907|NCT03689738|Other|Potato (Resistant Starch)|Potato lunch and dinner meals, and an evening snack containing 100 g potatoes and 5 g resistant starch (RS) per meal, providing a total of 300 g/d potatoes, equivalent to roughly two whole potatoes, and 15 g/d RS.
15894908|NCT03689738|Other|CHO-matched (Low-fiber, RS-free)|Isocaloric, CHO-matched, low-fiber, RS-free lunch and dinner meals, and an evening snack.
15894909|NCT03689725|Other|Music|Music created by A. Vollenweider at least 5 times per week from 33 weeks of gestational age until term-equivalent age
15894910|NCT03689712|Drug|GC4419|60 minute IV infusion
15894911|NCT03689712|Drug|Placebo|60 minute IV infusion
15894915|NCT03689686|Device|Noninvasive Respiratory Support|"Physiological crossover prospective study comparing four study trials (20 mins) delivered in computer generated random order:
~Standard Oxygen therapy with mask
~HFNC flow 2l/Kg
~HFNC flow 3l/Kg
~Helmet CPAP"
15894916|NCT03689673|Other|Data collection|
15894917|NCT03689660|Other|Virtual Reality Training|Participants will be given a game-based workout program that includes balance and weight transfers using the XBOX Kinect ™ device in a low-to-medium intensity for 3 weeks, 3 days a week, 30 minutes per day.
15894918|NCT03689660|Other|Biofeedback Training|biofeedback training will be applied to participants in 10-minute sessions with 10 seconds of voluntary contraction and 15 seconds of rest at each session. Training will last 12 weeks.
15894919|NCT03689660|Other|Conventional rehabilitation|Participants will receive a 12-week conventional rehabilitation program.
15894920|NCT03689647|Device|Arm Swing Driven Assistive Apparatus|The investigators are testing a simple, custom built apparatus to determine if it can facilitate the use of the arms to swing the legs during walking. More specifically, the investigators will measure how this assistive apparatus affects the metabolic cost and biomechanics of walking.
15894921|NCT03689634|Device|Move For Surgery Preconditioning Program using a Wearable Activity Tracker (Fitbit) Intervention Group|Participants randomized to this group will be be provided with a wearable activity tracker (Fitbit) for the duration of the study and asked to reach daily step goals.
15894922|NCT03689621|Device|Transcutaneous vagus nerve stimulation (tVNS)|
15894923|NCT03689608|Other|Intermittent Fasting (IF)|Participants will fast 3 days per week. In fasting days, meal replacements at 30% of daily energy requirements will be provided for the first 6 months. Participants will have fortnightly nutrition assessment.
15894924|NCT03689608|Other|Daily Restriction (DR)|Participants are instructed to restrict energy intake by 30% of daily energy requirements. Meal replacements will be provided for the first 6 months. Participants will have fortnightly nutrition assessment.
15894925|NCT03689608|Other|standard care (SC)|Participants will receive current practice guidelines in a static information format, will not take part in any counselling or receive meal replacements.
15894926|NCT03689595|Other|Sample of Blood|Collection of blood sample from participants
15894927|NCT03689582|Drug|68Ga-PSMA|"PET/CT imaging with 68Ga-PSMA:
~68Ga-PSMA is an investigational radioactive drug that binds to receptors on prostate cancer cells. The intravenously administered drug dose will be about 5 mCi (range 3-7 mCi)."
15894928|NCT03689569|Dietary Supplement|Resistant starch|Patients will receive 30 grams of resistant starch daily for 16 weeks or a placebo in a double blind fashion
15894929|NCT03689569|Behavioral|Exercise|Patients randomized to the exercise group will train aerobically for 16 weeks at a moderate exercise intensity
15894930|NCT03689569|Behavioral|Starch|Patients will be given 30 grams of corn starch
15894931|NCT03689556|Diagnostic Test|FLT PET/CT|Patients will receive 3'-deoxy-3'-[18F]fluorothymidine (FLT) PET/CT scans before CIRT and after completion of CIRT.
15894932|NCT03689543|Drug|ER beta agonist|We propose to evaluate the efficacy of a selective estrogen receptor (ER) beta agonist (Lilly Compound LY500307) to prevent estradiol withdrawal-induced mood symptoms. The effects of estradiol primarily occur through activation of two receptor subtypes, often with opposing outcomes: estrogen receptor (ER) alpha, and ER beta. We focus on ER beta because the beta estrogen receptor is reported to mediate the effects of estradiol on the serotonergic system and mediate the antidepressant-like effects of estradiol in the forced-swim test.
15894933|NCT03689543|Other|Placebo|Placebo
15894934|NCT03689530|Behavioral|Peer Support|"Participants will be paired with a peer supporter. They will meet in person one time and then be in contact by phone or texting on a weekly basis for the first 6 months of a year.
~During the final six months of the year, the peer supporter and participant will be in touch at least monthly. The peer supporter will help link participants to existing health system and community diabetes prevention programs, support their engagement in formal programs, maintain achieved gains, and support participants to initiate and sustain healthy behaviors to prevent diabetes."
15894935|NCT03689530|Behavioral|Enhanced Usual Care|Participants will receive brief education and folder of information and resources.
15894936|NCT03689517|Other|placebo|participants took placebos (pills made by starch) that were told to be an effective analgesic.
15894937|NCT03689517|Device|orthodontic elastic separators|Orthodontic pain was introduced by placement of orthodontic elastic separators to the mesial and distal sides of the right mandibular first molar.
15894938|NCT03689504|Dietary Supplement|Standard of care nutrition support|Subjects will be provided with a standard food ration and with a multiple micronutrient powder (Chispitas) or lipid-based nutrient supplement (Nutributter)
15894939|NCT03689504|Behavioral|Home-based nutrition education|Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.
15894940|NCT03689504|Behavioral|Home-based family gardening|Health promoters will facilitate the building and maintenance of a family home garden using a square foot or container gardening method.
15894941|NCT03689491|Behavioral|rTMS|The EMG measured the MEPs of the anterior tibialis in response to the TMS delivered using a Magstim Rapid2 stimulator (Magstim Co, Ltd, Carmarthenshire, Wales, UK) with a 70-mm figure-8 coil (maximum power, 2.2 T) over the contralateral M1. The intensity was initially set at 100% of the machine output (MO) to determine the optimal stimulation site (hotspot). The hotspot was marked on the scalp with oil ink and recorded as x, y, in centimeters from the vertex (cz). The participants received real rTMS or sham rTMS, respectively (1 Hz, 10 min), which was before a 30-minute visual feedback training and/or traditional rehabilitation training.
15894942|NCT03689491|Behavioral|visual feedback training|Game-based visual feedback training system and software.The system was designed to enable the subjects to perform ankle movements in multiple axes.
15894943|NCT03689491|Behavioral|traditional rehabilitation|30 min traditional rehabilitation. The traditional rehabilitation programs included balance training, postural training, muscle strengthening, ambulation training and etc..
15894944|NCT03689478|Other|Hyperthermic intravesical chemotherapy|Intravesical instillation of 40mg mitomycin C at 43 degrees for 60 minutes immediately after transurethral resection of bladder tumour
15895641|NCT03684070|Behavioral|Self-Monitoring, peer support and motivational prompts|The intervention compares the effect of technologically delivered motivational messages, and peer support upon daily step counts.
15894945|NCT03689465|Drug|ATG|In PTCy-ATG group, ATG will be intravenously infused via a central venous catheter from day -3 until day -1 at a total dose of 4.5mg/kg. In ATG group, ATG will be intravenously infused via a central venous catheter from day -5 until day -2 at a total dose of 7.5mg/kg.
15894946|NCT03689465|Drug|CTX|In PTCy-ATG group, CTX will be intravenously infused via a central venous catheter on day +4 at a dose of 50mg/kg/d.
15894947|NCT03689465|Drug|Mycophenolate Mofetil|In PTCy-ATG group, Mycophenolate Mofetil will be taken orally from day +5 with the dosage of 0.5g twice a day. The dosage will be halved from day +30. In ATG group, Mycophenolate Mofetil will be taken orally from day -9 with the dosage of 0.5g twice a day. The dosage will be halved from day +30.
15894948|NCT03689465|Drug|Ciclosporin A (CsA)|In PTCy-ATG group, Ciclosporin A (CsA) will be intravenously infused from day +5 at a dose of 2.5mg/kg/d. In ATG group, Ciclosporin A (CsA) will be intravenously infused from day -9 at a dose of 2.5mg/kg/d.
15894949|NCT03689465|Drug|methotrexate (MTX)|In ATG group, methotrexate (MTX) will be intravenously on days +1, +3 and +6.
15894950|NCT03689452|Device|Platelet Rich Plasma|Platelet Rich Plasma (PRP) is defined as an autologous concentration of human platelets that is 3 to 5 times greater than physiologic concentration of platelets in whole blood. Using the Eclipse PRP system, the participants PRP will be attained. The PRP will then be used as described in the arm/group description section.
15894951|NCT03689452|Drug|Normal saline|Preservative-free normal saline will be used as described in arm/group description section.
15894952|NCT03689439|Diagnostic Test|bone scintigraphy|bone scintigraphy
15894953|NCT03689413|Drug|Sugammadex 200 MG in 2 ML Injection|1 mg/kg or 2 mg/kg intravenous injection for each group (1 mg/kg group, 2 mg/kg group) after tracheal intubation
15894954|NCT03689387|Other|the Medical Program Information Systems (PMSI)|The selection of the files will be carried out using the Medical Program Information Systems (PMSI) and search convocations for post-stroke follow-up consultations conducted by the Secretariat of Neurological MPR Amiens University Hospital.
15894955|NCT03689374|Drug|Semaglutide|Subjects will receive subcutaneous (s.c., under the skin) injections of semaglutide once weekly (OW) with a dose of 0.25 mg. The dose should be increased after four weeks to 0.5 mg semaglutide. After 4 more weeks the dose can be increased to 1.0 mg semaglutide if the study doctor decides and further dose adjusted throughout the study.
15894956|NCT03689374|Drug|Insulin aspart|Subjects should initiate treatment with 4U of Insulin aspart (s.c. injections) before each main meal, three times daily (TID). The dose will be adjusted individually based on pre-prandial and bedtime self measured plasma glucose (SMPG) from the preceding 3 days
15894957|NCT03689374|Drug|Insulin glargine U100|Run-in period: Subjects will receive s.c. injections of IGlar U100 OD in accordance with the approved local label of IGlar U100. The dose will be adjusted based on the mean of three pre-breakfast SMPG values (target SMPG: 4.0-6.9 mmol/L)
15894958|NCT03689361|Combination Product|MRI|Routine MRI with all the sequences performed for the management of acute neurological deficit in the Toulouse Neuro Vascular Unit (diffusion, FLAIR, T2 *, vascular sequences (AngioRM and TOF) and perfusion).
15894959|NCT03689361|Diagnostic Test|MRI control|MRI with all the sequences performed for the management of acute neurological deficit in the Toulouse Neuro Vascular Unit (diffusion, FLAIR, T2 *, vascular sequences (AngioRM and TOF) and perfusion)
15894960|NCT03689361|Other|telephone consultation|telephone consultation
15894961|NCT03689348|Dietary Supplement|Avena sativa|A supplement derived from wild green oat
15894962|NCT03689348|Dietary Supplement|Placebo|Maltodextrin
15894963|NCT03689335|Procedure|Operative|Open reduction and internal fixation, using a plate and screws (the exact surgical approach and fixation technique utilised will be at the discretion of the treating surgeon)
15894964|NCT03689335|Device|Humeral brace|Immobilisation in a U-slab or hanging cast, followed by application of a lightweight prefabricated humeral brace
15894965|NCT03689322|Other|WBV + IMT|The whole body vibration training will be performed through a vibrating platform with three axes and vibration frequency set at 35 Hz. The amplitude used will be 02 to 04 mm.The inspiratory muscle training will be performed through a device that provides inspiratory resistance.
15894966|NCT03689322|Other|WBV + IMTsham|The whole body vibration training will be performed through a vibrating platform with three axes and vibration frequency set at 35 Hz. The amplitude used will be 02 to 04 mm.The inspiratory muscle training sham will be performed through a device without inspiratory resistance.
15894967|NCT03689322|Other|WBVsham + IMTsham|Whole body vibration training will be performed through a vibrating platform coupled to a device that generates non-therapeutic low frequency vibration. The simulation of inspiratory muscle training will be performed through a device with no inspiratory resistance.
15894968|NCT03689309|Procedure|High Flow Oxygen SBT|The patient is disconnected from the ventilator and remains 30 minutes without support but high flow oxygen delivered through a dedicated piece that is usually connected on tracheotomy.
15894969|NCT03689296|Other|Questionnaires|"CardioVascular Risk (CVR) questionnaire representation
~SF12
~Citizenship Measurement (CM) Scale
~Recovery Assessment Scale
~Score Ricci-Gagnon"
15894970|NCT03689283|Other|Dry Needling|Individuals randomized to the Dry Needling Group will receive dry needling to latent trigger points of the gastrocnemius muscle
15894971|NCT03689283|Other|Sham Dry Needlling|Individuals randomized to the Control group will receive sham needling to the gastrocnemius muscle
15894972|NCT03689270|Procedure|Subluxation|One pole of The nucleus is hydrodissected until it lilts above the capsular bag. The tilted nucleus is rotated to face the incision and remaining half nucleus is then tumbled and emulsification continues from the opposite equator outside in until complete.
15894973|NCT03689270|Procedure|Divide and conquer|Cataract nucleus is fragmented into 4 pieces then aspirated by ultrasonic vibration
15894974|NCT03689244|Drug|Selexipag|oral tablets containing 200 µg of selexipag. Depending on the iMTD, subjects will receive 1 to 8 tablets at each administration
15894975|NCT03689244|Drug|Placebo|Oral tablets without active compound
15895018|NCT03688997|Other|Simulator training|bench-top simulator with computer acquired assessments, designed to allow novices to acquire basic surgical skills in knot tying. The simulator measures the forces used and applied on the tissue while ligating a vessel. Simulator training was included in both arms (expert and novice groups).
15895642|NCT03684070|Behavioral|Self-monitoring|Self-monitoring of data from wearable step count tracker
15911426|NCT03563144|Drug|Bevacizumab|Bevacizumab
15894976|NCT03689231|Other|Volumetric measurements of liver metastases|"Depending on the available data and to be reproducible, patients will be divided into 2 sub-groups of follow-up imaging: CT only or MRI only, combined evaluation being not reliable for tumor detection
~Patient follow-up at CT or MRI will be analyzed at baseline (date of discovery of hepatic metastatic disease), then 3-6 months after the start of the study, then annually.
~At each assessment, a radiologist will analyze: the total volume of liver metastases (mm3), the estimated volume of the two target lesions chosen for RECIST follow-up (mm3), the number of liver lesions, and the evolution according to the RECIST criteria based on uni-dimensional measurements.
~We will then correlate the following clinical data collected for patients: age, sex, presence of a carcinoid syndrome, Ki67 (%) and chromogranin A blood level (%) at diagnosis, number and location of other metastases, Octreoscan or Stereotactic Radio Surgery data if available."
15894977|NCT03689218|Dietary Supplement|Maamta (Nutritious Food Supplement)|Pregnant women will receive 30 sachets of Maamta during pregnancy and first six months of lactation.
15894978|NCT03689218|Dietary Supplement|Wawamum (Lipid-Based Nutrient Supplement)|Children 6-24 months will receive 30 sachets of Wawamum every month during the study.
15894979|NCT03689192|Biological|ARG1-18,19,20|300 ug ARG1-18,19,20 peptide in water mixed with 500ul montanide
15894980|NCT03689179|Behavioral|Time for Living and Caring (TLC)|"Time for Living & Caring (TLC) is an online, self-administered intervention. It includes three types of modules: a virtual coaching module (defined as a series or prompts, reminders, and suggestions delivered electronically through an interactive calendar website) that guides caregivers through assessment, goal setting, and goal review activities using an interactive calendar for each planned respite period they have. Supplementary modules provide education and resources such as What is Respite?, Why is Respite Important?, How do I Get (More) Respite?, How do I Use Respite?. Optional modules include interactive online forum, peer-to-peer chat functions, and videos or messages to provide daily affirmation, inspiration, and humor for caregivers."
15894981|NCT03689166|Dietary Supplement|Probiotic|Reduce preterm birth with this dietary supplement
15894982|NCT03689166|Other|Placebo|Placebo
15894983|NCT03689153|Drug|JNJ-63733657|Single ascending IV low, middle, and high dose of JNJ-63733657 will be administered in sequential cohorts. The progression to the next (higher) dose level is dependent on acceptable safety and tolerability profile of JNJ-63733657 obtained after dose administration of the current dose level. The length of time between dosing days of cohorts will be at least 14 days.
15894984|NCT03689153|Drug|Placebo|Participants will receive matching placebo intravenously.
15894985|NCT03689140|Behavioral|Smoke Free Together - App-only|Pregnant smokers and their life partners will use a smoking cessation app.
15894986|NCT03689140|Behavioral|Smoke Free Together - Telemedicine counseling only|Pregnant smokers and their life partners will use telemedicine, real time video counseling on smoking cessation
15894987|NCT03689140|Behavioral|Smoke Free Together - app + telemedicine|Pregnant smokers and their life partners will use telemedicine and an app for smoking cessation
15894988|NCT03689127|Device|Heated breathing circuit on|Heated breathing circuit will be turned on.
15894989|NCT03689127|Device|Heated breathing circuit off|Heated breathing circuit will be turned off.
15894990|NCT03689114|Drug|Low dose carbamazepine|Carbamazepine, 300 mg/die
15894991|NCT03689114|Drug|Standard dose carbamazepine|Carbamazepine 600 mg/die
15894992|NCT03689114|Drug|Low dose levetiracetam|Levetiracetam 500 mg/die
15894993|NCT03689114|Drug|Standard dose levetiracetam|Levetiracetam 1000 mg/die
15894994|NCT03689114|Drug|Low dose valproate|Valproate 300 mg/die
15894995|NCT03689114|Drug|Standard dose valproate|Valproate 600 mg/die
15894996|NCT03689114|Drug|Low dose zonisamide|Zonisamide 150 mg/die
15894997|NCT03689114|Drug|Standard dose zonisamide|Zonisamide 300 mg/die
15894998|NCT03689114|Drug|Low dose oxcarbazepine|Oxcarbazepine 600 mg/die
15894999|NCT03689114|Drug|Standard dose oxcarbazepine|Oxcarbazepine 1200 mg/die
15895000|NCT03689114|Drug|Low dose topiramate|Topiramate 100 mg/die
15895001|NCT03689114|Drug|Standard dose topiramate|Topiramate 200 mg/die
15895002|NCT03689114|Drug|Low dose lamotrigine|Lamotrigine 100 mg/die
15895003|NCT03689114|Drug|Standard dose lamotrigine|Lamotrigine 200 mg/die
15895004|NCT03689114|Drug|Low dose gabapentin|Gabapentin 450 mg/die
15895005|NCT03689114|Drug|Standard dose gabapentin|Gabapentin 900 mg/die
15895006|NCT03689101|Procedure|Endometrial biopsies|Endometrial biopsy was performed precisely 7 days after LH surge (LH+7)
15895007|NCT03689088|Device|Goldfish|Goldfish will be placed in the eye for 24h monitoring
15895008|NCT03689088|Device|Tonometry|Fellow eye will be measured by tonometry
15895009|NCT03689075|Drug|Envarsus Oral Product|Patients will be randomised to receive either envarsus or to continue on an immediate release tacrolimus formulation
15895010|NCT03689062|Procedure|induction of labor|oxytocin intravenous drip
15895011|NCT03689062|Procedure|follow up|hospitalization and antibiotics
15895012|NCT03689049|Procedure|SPIDER|The SPIDER intervention will include a family physician-led inter-professional practice team participating in 3-4 Learning Collaboratives over a period of 12 months, reviewing validated and comparable practice EMR data and working with a QI Coach to develop strategies and implement changes to improve care for elderly patients living with complex care needs and taking ten or more unique medications.
15895013|NCT03689049|Procedure|Usual Care|Physicians and their teams enrolled in this arm will follow the best scientific evidence available to provide standard care that is in the best interest of their patients.
15895014|NCT03689023|Other|A controlled multimodal intervention|The intervention is interdisciplinary, multimodal and patient activating and uses the existing setting and work flows at the Clinic as well as new interventions, ensuring that the patients receive education about cardiovascular risk factors, physical activity and healthy diet through a systematic approach including targeted patient education
15895015|NCT03689010|Drug|Azelaic acid foam 15%|Azelaic acid foam 15%
15895016|NCT03689010|Drug|Finacea® (Azelaic acid Foam) 15%|Azelaic acid foam 15%
15895017|NCT03689010|Drug|Vehicle of the test product|Vehicle of the test product
15895708|NCT03683485|Procedure|EST|After deep cannulation was achieved, a complete sphincterotomy was performed with a 25-mm pull-type sphincterotome (Clever Cut 3; KD-V411M, Olympus, Tokyo, Japan) and the sphincter was divided up to the transverse duodenal fold.
15895019|NCT03688984|Behavioral|Cognitive Behavioural Therapy for Insomnia|Cognitive Behavioural Therapy for Insomnia (CBT-I) consists of six individual therapy sessions that last approximately one hour each. The sessions include psychoeducation about insomnia, goal setting, relaxation training, stimulus control, sleep consolidation and medication review. Additional components include cognitive therapy, sleep hygiene and mindfulness and relapse prevention.
15895020|NCT03688971|Drug|Omiganan|Omiganan Topical Gel
15895021|NCT03688971|Drug|Ketoconazole|Ketoconazole Cream
15895022|NCT03688971|Drug|Placebo|Vehicle
15895023|NCT03688958|Drug|Placebo|Selected patients with early breast cancer (stage II) non-pretreated received colored water solution (placebo) within the time before the hospital assigned them to her surgery (7 to 35 days).
15895024|NCT03688958|Drug|iodine|Selected patients with early breast cancer (stage II) non-pretreated received iodine solution (Experimental) within the time before the hospital assigned them to her surgery (7 to 35 days).
15895025|NCT03688958|Drug|FEC/TE Placebo|The selected patients with advanced breast cancer (stage III) non-pretreated received colored water solution (placebo) within the time of oncology designed chemotherapy treatment FEC/TE (4 or 6 cycles/ every 21 days).
15895026|NCT03688958|Drug|FEC/TE iodine|The selected patients with advanced breast cancer (stage III) non-pretreated received iodine solution (experimental) within the time of oncology designed chemotherapy treatment (4 or 6 cycles/ every 21 days).
15895027|NCT03688945|Procedure|Art Therapy|Attend art viewing sessions
15895028|NCT03688945|Other|Best Practice|Receive standard of care
15895029|NCT03688945|Other|Questionnaire Administration|Ancillary studies
15895030|NCT03688932|Other|WBV + IMT|The whole body vibration training will be performed through a vibrating platform with three axes and vibration frequency set at 35 Hz. The amplitude used will be 02 to 04 mm.The inspiratory muscle training will be performed through a device that provides inspiratory resistance.
15895031|NCT03688932|Other|WBV + IMTsham|The whole body vibration training will be performed through a vibrating platform with three axes and vibration frequency set at 35 Hz. The amplitude used will be 02 to 04 mm.The inspiratory muscle training sham will be performed through a device without inspiratory resistance.
15895032|NCT03688932|Other|WBVsham + IMTsham|Whole body vibration training will be performed through a vibrating platform coupled to a device that generates non-therapeutic low frequency vibration. The simulation of inspiratory muscle training will be performed through a device with no inspiratory resistance.
15895033|NCT03688919|Behavioral|Self-Regulation Intervention|The intervention targets Executive Functioning (EF), Emotion Regulation (ER) and Future Orientation (FO). The intervention will occur through home practice and text based reminders and mobile apps to practice techniques. For EF, youth will use the NBack intervention, a computer-based working memory training game. For ER, participants will engage in relaxation and biofeedback activities by completing activities (e.g., modulating breathing to keep heart rate) while wearing sensors. For FO, participants will envision and describe future events they are looking forward to, using concrete, vivid descriptive language. These descriptions will be audio recorded so that the participant can play back the cues at home at specified times of day (e.g., 7am and 3:30PM).
15895034|NCT03688893|Device|Laser Application for Dental Bleaching|The Laser used was the Whitening Lase II (DCM EQUIPMENTS).
15895035|NCT03688880|Device|MAR-CUTIS|MAR-CUTIS was applied in 1 to 2 mm thick layer, ensuring that at least 1 cm of the glue was applied over the length of the wound on each side. The amount of the glue applied was calculated such that one 5-mL syringe covers approximately 8 cm of wound length (giving a total of 10 cm per syringe). For wounds >8 cm, 2 syringes were required.
15895036|NCT03688880|Device|Dermabond Advanced|Dermabond Advanced was applied in 1 continuous layer onto a dry wound through painting motions, taking care not to apply adhesive between the wound edges.
15895037|NCT03688867|Behavioral|Prehabilitation regimen|"The intervention targets individual behavior, specifically a patient's proclivity to exercise prior to pancreatic resection. The prehabilitation program is tailored to the three most commonly used objective frailty metrics currently available and will be implemented during the initial consultation visit in the surgery outpatient clinic, where patients will undergo baseline testing and then provided with a fitness tracker and stress ball.
~Additionally, they will be provided with an activity log to keep track of their daily activity. Shown below is the activity log."
15895038|NCT03688854|Dietary Supplement|SCFA mixture|Intracolonic administration
15895039|NCT03688841|Device|Bridged V.A.C.® with compression therapy|Patients randomised to receive Bridge VAC with compression dressings will be managed using ActiV.A.C. Therapy unit, with a continuous pressure of 125mmHg. A V.A.C.® Granufoam™ Bridge Dressing will be used instead of the tube connector. A Coban™ Lite compression dressing will be placed over the VAC dressing. The Bridge connector of the VAC will be used to tunnel underneath the Coban™ Lite till the upper edge of the dressing.
15895040|NCT03688841|Device|Conventional Compression Therapy|Patients randomised to receive compression dressings will be managed using Coban™ Lite compression dressings with underlying non-adherent wound contact layer (WCL) dressings. Under the supervision of the investigating clinician, the dressings will be applied by a wound care specialist nurse and changed once to three times per week (depending on amount of exudate), until full ulcer healing or up to 12 weeks.
15895046|NCT03688815|Diagnostic Test|myocardial perfusion scintigraphy|Myocardial perfusion scintigraphy as it is described in the international literature.
15895047|NCT03688802|Drug|OC-01|OC-01
15895048|NCT03688802|Drug|Placebo|Placebo
15895049|NCT03688789|Other|Hydrocortisone supplementation|"Cortisol at T0 and T30 mins less than 550 nmol / L after ACTH 250 μG achieved during the last chemotherapy session
~Hydrocortisone supplementation in patients with biological adrenal insufficiency
~scale of quality of life estimated by EORTC QLQ-C30"
15895050|NCT03688776|Other|1805AA|A moist snuff product
15895051|NCT03688776|Other|1805AB|A moist snuff product
15895052|NCT03688763|Behavioral|Cognitive Behavioral Therapy for Insomnia (CBT-i)|CBT-i is an evidence-based treatment for insomnia. Participants will receive CBT-i via online program (Sleepio).
15895053|NCT03688750|Other|no intervention|
15895054|NCT03688737|Other|low level laser|LLLT with wavelength (λ) of (600 nm to 700nm), The laser will be held 1 cm away from the surface of the target tissue, the irradiated area is 0,5 cm2.The area of impact is the surgical wound zone and the neighboring 0,5-1,0 cm of the adjacent oral mucosa for 1min and 22sec, at day of surgery, 1st day and 3rd day and come for follow up visits at 5th day ,2 weeks, month and 3 months postoperative
15895055|NCT03688737|Other|placebo|placebo like device as it like low level laser device shape but with no effect to blind the intervention
15895056|NCT03688711|Drug|Dasiglucagon|Glucagon analogue
15895057|NCT03688711|Drug|Placebo|Placebo for dasiglucagon
15895058|NCT03688698|Radiation|PET/MRI|PET/MRI scans
15895059|NCT03688685|Drug|CAD-1883|Treatment groups receiving twice-daily oral dosing of CAD-1883 for a treatment period of 14 days.
15895060|NCT03688672|Device|Apioc Contact Lens Design|Novel soft contact lens design.
15895061|NCT03688659|Drug|Vancomycin and gentamycin|intravenous
15895062|NCT03688646|Dietary Supplement|Intensive Nutrition Intervention|
15895063|NCT03688633|Drug|Candesartan|Candesartan treatment with dose adjustments (8-16mg/day) during 6 months in accordance with adverse effects
15895064|NCT03688633|Other|Usual care|patients will be followed as usual
15895065|NCT03688620|Other|Passive enhanced safety surveillance|Prospective data collection starting at Visit 1 (Day 1) and ending at Visit 2 (Day 8 or when the ADR card was returned by mail) for all subjects who have previously been vaccinated against influenza in preceding seasons or aged ≥9 years at the time of vaccination, or ending at Visit 4 (Day 36 or when the last ADR card was returned by mail) for children aged <9 years who have not previously been vaccinated against influenza in preceding seasons). Subjects had up to 14 days post vaccination to return their ADR card (at the next study visit or by mail).
15895066|NCT03688607|Procedure|There will not be an intervention, rather the investigators will deploy best practices and track POKEs within the healthcare system to evaluate clinical and operational outcomes.|There will not be an intervention, rather the investigators will deploy best practices and track POKEs within the healthcare system to evaluate clinical and operational outcomes.
15895067|NCT03688594|Diagnostic Test|NIPT Test|This test is based onto capture and high throw put sequencing adapted to cell free plasmatic DNA of pregnant women in order to detect point mutation present in her fetus. This approach has been previously described for others clinical applications such as liquid biopsy in cancers but not for NIPT analysis.
15895068|NCT03688568|Drug|Imatinib Mesylate|Imatinib given orally as dose escalation treatment.
15895069|NCT03688555|Drug|ACT-774312|ACT-774312 will be available as hard gelatin capsules containing 200 mg of ACT-774312
15895070|NCT03688555|Drug|Placebo|Matching placebo capsules
15895071|NCT03688542|Other|Quality Circle Deprescribing Module|The Quality Circle Deprescribing Module consist of a discussion bringing together nurses, physicians and responsible pharmacist to create a local deprescribing consensus for frequently used drug classes, as well as implementation strategies for the consensus..
15895072|NCT03688516|Behavioral|Manipulation of valence and modality|mnemic task with a phase of encoding negative, positive and neutral stimuli, will be proposed followed by an immediate recovery phase, composed of a recall task followed by a recognition task
15895073|NCT03688516|Behavioral|Spatial and recognition memory|mnemic task with a phase of encoding negative, positive and neutral stimuli, will be proposed followed by an immediate recovery phase, composed of a recall task followed by a recognition task
15895074|NCT03688516|Behavioral|Source and content memory|mnemic task with a phase of encoding negative, positive and neutral stimuli, will be proposed followed by an immediate recovery phase, composed of a recall task followed by a recognition task
15895075|NCT03688503|Dietary Supplement|magnesium glycinate supplement|magnesium glycinate (480 mg/day)
15895076|NCT03688503|Dietary Supplement|placebo|placebo
15895077|NCT03688477|Device|iovera°|iovera° is minimally-invasive procedure using cold to target sensory nerve tissue and provide temporary pain relief through cryoneurolysis. The iovera° device uses well-established principles of cryobiology to temporarily deactivate sensory nerves that contribute to pain
15895078|NCT03688464|Drug|Melatonin|Drug to be administered for 4 weeks. Subjects will complete surveys prior to initiation and at the end of the study that will assess severity of eczema, quality of life, severity of itch, and sleep quality.
15895079|NCT03688464|Drug|Diphenhydramine|Drug to be administered for 4 weeks. Subjects will complete surveys prior to initiation and at the end of the study that will assess severity of eczema, quality of life, severity of itch, and sleep quality.
15895080|NCT03688464|Drug|Placebos|Drug to be administered for 4 weeks. Subjects will complete surveys prior to initiation and at the end of the study that will assess severity of eczema, quality of life, severity of itch, and sleep quality.
15895081|NCT03688451|Drug|Rituximab|Intrathecal administration over 3-5 minutes
15895082|NCT03688438|Device|Closed-Incision Negative-Pressure Therapy|A foam or gauze dressing is put directly on the wound. This foam acts as a filter to keep any large particles (such as blood clots or dead, sloughed off tissue) from clogging the vacuum system. A clear, occlusive, adhesive film covers and seals the dressing and wound, creating an airtight seal. A drainage tube leads from under the adhesive film and connects to a portable vacuum pump. This pump removes air pressure over the wound. The pump is programmed for strength of suction, amount of time it is to be applied and if it is to be intermittent or continuous. A chamber on the pump collects drainage and moisture is drawn away from the wound site.
15895083|NCT03688425|Device|IOL implantation experimental|Implantation of trifocal IOL POD F GF consisting of light distribution order: far > intermediate > near
15895084|NCT03688425|Device|IOL implantation active comparator|Implantation of trifocal IOL POD F GF consisting of light distribution order: far > near > intermediate
15895085|NCT03688412|Device|Cook lead extraction devices|The Cook lead extraction devices are mechanical devices that encompass a full variety of devices required for percutaneous removal of CIED leads, indwelling catheters and foreign objects.
15895086|NCT03688399|Device|IOL implantation experimental|Implantation of trifocal IOL POD F GF consisting of light distribution order: far > intermediate > near
15895087|NCT03688399|Device|IOL implantation comparator|Implantation of trifocal IOL POD F GF consisting of light distribution order: far > near > intermediate
15895735|NCT03683225|Combination Product|CTC-413|pramipexole ER, given with aprepitant
15911427|NCT03563144|Drug|Capecitabine|Capecitabine
15895088|NCT03688386|Behavioral|Reading intervention|Written packet with 3 lessons. The first lesson includes how to begin to read and talk to their baby. The second lesson includes reading or talking about the day using parentese talk. The third lesson includes continuing to engage with the baby through interactive reading.
15895089|NCT03688386|Behavioral|Infant bonding|Written packet with 3 lessons. The first lesson includes skin-to-skin and learning about their baby. The second lesson includes learning readiness cues and participation in feeding times. The third lesson includes developing routines and playing games.
15895090|NCT03688386|Behavioral|LENA recording|The LENA device provide 16 hours of language recordings placed inside an infant vest. The recordings are uploaded to a computer which analyzes total adult word counts, infant vocalizations, conversational turns, background noise, and silence.
15895091|NCT03688386|Behavioral|LENA linguistic feedback|LENA recordings of adult word counts, infant vocalizations, and conversational turns will be provided in printed form after each recording with review of each recording and progress over time.
15895092|NCT03688386|Behavioral|LENA summary|All 3 LENA recording summaries of adult word counts, infant vocalizations, and conversational turns will be summarized in printed form and provided to mother at discharge.
15895093|NCT03688373|Behavioral|Cognitive Behavioral Therapy|Each intervention will contain a 60-minute psycho-education session (PE) and two 60-minute exposure sessions (EX), conducted by a mental health professional together with a master student in psychology, who are both weekly supervised by a CBT certified psychologist. In the first (PE) session, participants learn about anxiety, specific phobias and exposure. During this session they will create a fear hierarchy (1 relating to least fearful and 10 indicating most fearful situation), formulate their cognition about the feared object or situation and determine what they want to achieve during treatment (e.g. goal situation). The next two sessions consist of exposure exercises in either big or small steps.
15895094|NCT03688360|Behavioral|Cognitive Behavioral Therapy|. Each intervention will contain a 60-minute psycho-education session (PE) and two 60-minute exposure sessions (EX), conducted by a mental health professional together with a master student in psychology, who are both weekly supervised by a CBT certified psychologist. In the first (PE) session, participants learn about anxiety, specific phobias and exposure. During this session they will create a fear hierarchy, formulate their cognition about the feared object or situation and determine what they want to achieve during treatment (e.g. goal situation). The next two sessions consist of exposure exercises.
15895095|NCT03688347|Procedure|Nasal Swab|The swab is removed from packaging, moistened with sterile water if needed to prevent any discomfort to the participant. The swab is gently inserted less than one inch into the anterior nare (nostril) until resistance is met at turbinate. Then it is rotated several times against nasal wall and repeated in other nostril using the same swab.
15895096|NCT03688347|Procedure|Oral Swab|The swab is removed from packaging, moistened with sterile water if needed to prevent any discomfort to the participant. The swab is gently rubbed along the inside of the participant's cheek for 5-10 seconds.
15895097|NCT03688347|Other|Stool Collection|A stool collection kit will be sent home with each participant. It will include instructions on how to collect the stool specimen and how to return the kit.
15895098|NCT03688347|Genetic|Microbiome analysis|Study of microbial communities found in and on the human body.
15895099|NCT03688347|Genetic|DNA Banking|Secure, long term storage of an individual's genetic material.
15895100|NCT03688347|Procedure|Skin Swab|Gentle rubbing of the swab will be applied to the skin on the dorsal part of the hand.
15895101|NCT03688334|Drug|Oxygen 40 %|Oxygen supplementation (40%) via Venturi mask
15895102|NCT03688334|Drug|Medical air (sham O2)|Medical air supplementation via Venturi mask
15895103|NCT03688321|Dietary Supplement|Probiotic capsule GR-1 and RC-14|Study Group will take 2 probiotics capsules containing 1 billion colony forming unit(CFU) of Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 each before sleep for 18 weeks starting at 28th week gestation
15895104|NCT03688321|Dietary Supplement|Placebo capsule|Placebo Group will take 2 placebo capsules before sleep for 18 weeks starting at 28th week gestation
15895105|NCT03688308|Procedure|Arthroscopic rotator cuff repair with bone marrow aspirate concentrate|Subjects will undergo shoulder arthroscopy for rotator cuff repair using a double row technique. Subjects will also be injected with bone marrow aspirate concentrate harvested from the pelvis and centrifuged prior to injection in the shoulder (produced using the Harvest/Terumo BCT system)
15895106|NCT03688308|Procedure|Arthroscopic rotator cuff repair|Subjects will undergo shoulder arthroscopy for rotator cuff repair using a double row technique.
15895107|NCT03688295|Other|No antibiotics|Patients will not receive antiobitherapy post surgery for CAA
15895108|NCT03688295|Drug|Antibiotics|Patients will receive antiobitherapy post surgery for CAA
15895109|NCT03688282|Device|Wearable vibration belt|The device is worn, a wearable vibration belt, for a specified time. This will provide vibration starting at the hips.
15895110|NCT03688282|Device|Sham, wearing belt|The device is worn, for a specified time. It will not be turned on during this period. It is only sham.
15895111|NCT03688269|Drug|Intravenous dexamethasone|Intravenous injection of 8mg/2ml dexamethasone
15895112|NCT03688269|Drug|Intravenous saline|Intravenous injection of 2ml Saline 0.9%
15895113|NCT03688269|Drug|Perineural ropivacaine|Perineural injection of 20ml ropivacaine with adjustment of the concentration determined by sequential up and down method
15895114|NCT03688256|Device|Obalon Balloon System|6 month Obalon Intragastric Balloons
15895115|NCT03688243|Device|SS-OCT imaging|All subjects will undergo retinal imaging using the Zeiss PlexElite SS-OCT, a non-contact, non-invasive ocular imaging instrument
15895116|NCT03688230|Drug|abituzumab|1000 mg IV
15895117|NCT03688230|Combination Product|Placebo + Cetuximab + FOLFIRI|400 mg/m2 over 120 min followed by 250 mg/m2 weekly 60 min or 500 mg/m2 every two weeks, initially 120 min followed by 60 to 90 min
15895147|NCT03688009|Behavioral|Mindfulness-Based Family Psycho-Education (MBFBE)|Six sessions includes: 1. Working with Caregiving Stress; 2. The Struggles of a Caregiver; 3. The Struggles of a Person in Recovery; 4. The Path of Recovery; 5. A Supportive Caregiving; and 6. Review of Learning.
15895148|NCT03688009|Behavioral|Family Psycho-Education (FPE)|Six sessions includes: 1. Working with Caregiving Stress; 2. The Struggles of a Caregiver; 3. The Struggles of a Person in Recovery; 4. The Path of Recovery; 5. A Supportive Caregiving; and 6. Review of Learning.
15912540|NCT03554408|Drug|3BNC117-LS|Intravenous infusion of 3BNC117-LS
15895118|NCT03688217|Behavioral|Philani Intervention Model+MOVIE (PIM+M)|The PIM+M intervention will involve the integration of the mobile video intervention into the standard perinatal counseling program offered by the intervention mentor-mothers. MOVIE intervention videos are narrated in English and isiXhosa, the languages spoken most widely among the study participants. Teaching videos are short (2-5 min.) and use simple language, avoiding medical jargon. The modularity of the videos facilitates delivery in any order and thus, they can be deployed at the discretion of each skilled mentor-mother, such that the health messages delivered are aligned with the individual needs of each participant at each perinatal stage. All videos will be administered at least once to each participant in the intervention group during the study period.
15895119|NCT03688217|Behavioral|Philani Intervention Model (PIM)|The Philani Intervention Model (PIM) describes a structured program of antenatal and postnatal home-visits covering foundational health promotion topics including nutrition in pregnancy, infant feeding, newborn care and maternal mental health among others.
15895120|NCT03688191|Drug|Sirolimus|Patients will receive oral sirolimus at a starting dose of 2 mg per day for 3 days and a sequential dose of 1mg per day, with dose adjusted according to tolerance and to maintain a therapeutic range of 6-15 ng/mL.
15895121|NCT03688178|Biological|Human CMV pp65-LAMP mRNA-pulsed autologous DCs|2x10^7 human CMV pp65-LAMP mRNA-pulsed autologous DCs are given intradermally and bilaterally at the groin site (divided equally to both inguinal regions). Patients will receive up to a total of 10 DC vaccines.
15895122|NCT03688178|Drug|Temozolomide|Temozolomide is a standard chemotherapy given to all enrolled patients at a targeted dose of 150-200mg/m2/d for 5 days every 4 (+ 2) weeks for up to 12 cycles (patients with unmethylated MGMT gene promoter will receive only cycle 1)
15895123|NCT03688178|Biological|Varlilumab|Varlilumab is an agonist anti-CD27 monoclonal antibody
15895124|NCT03688178|Biological|Td|A single dose of Td toxoid (1 flocculation unit, Lf, in 0.4 mLs) administered to a single side of the groin given intradermally
15895125|NCT03688178|Biological|Unpulsed DCs|Patients in Group I will receive 1 x 10^6 autologous unpulsed DCs in saline administered to a single side of the groin intradermally 1 day before the fourth vaccine.
15895126|NCT03688165|Device|Treadmill-based Robotic Gait Training|All the stroke survivors admitted to the participating centers and eligible for the study will follow a gait training protocol (treadmill-based or overground). The data will be registered at baseline (T0), end of treatment (T1) and at three months follow up (T2). All robotic systems used for the study (Lokomat Pro - Hocoma AG, Volketswil, Switzerland); G-EO System - Reha technologies, Italy) are treadmill-based and do not provide the over-ground gait training. They are characterized by the possibility of a programmable weight support, as well as speed and stride length. The data relating to the patients' training is always displayed and stored with a computerized control system.
15895127|NCT03688152|Drug|INCB053914|"Dose Escalation: INCB053914 at the protocol-defined starting dose in combination with INCB050465, with dose modifications based on tolerability criteria.
~Dose Expansion: Recommended dose from the dose-escalation study."
15895128|NCT03688152|Drug|INCB050465|"Dose Escalation: INCB050465 at the protocol-defined starting dose in combination with INCB053914, with dose modifications based on tolerability criteria.
~Dose Expansion: Recommended dose from the dose-escalation study."
15895129|NCT03688139|Behavioral|Engage Therapy|"Engage therapy is designed to help individuals with depression become involved in activities they previously enjoyed but have not been participating in since developing depression. In Engage therapy, individuals with depression work with a therapist to develop action plans to pursue rewarding activities of their choice."
15895130|NCT03688139|Behavioral|Supportive Therapy|Supportive therapy is designed to provide a warm and supportive environment in which individuals with depression can feel comfortable expressing their thoughts and feelings. In supportive therapy, therapists help patients identify themes in their thinking, provide reassurance, emphasize coping skills, and provide guidance as needed.
15895131|NCT03688126|Behavioral|Self-Guided Lifestyle Intervention|Lifestyle intervention that involves providing participants with education, support, and tangible tools to assist them in developing and carrying out healthier lifestyle practices.
15895132|NCT03688126|Behavioral|Structured Lifestyle Intervention|Lifestyle intervention that involves a structured program of diet, physical and cognitive exercise, and management of cardiometabolic risks.
15895133|NCT03688113|Behavioral|Tinnitus application|Use of tinnitus application
15895136|NCT03688087|Device|"Smartphone application placebo"|"Strategy based on smartphone application placebo"
15895137|NCT03688087|Device|"Smartphone equipped with application bouge = Coach group"|"Strategy based on smartphone application bouge"
15895138|NCT03688074|Biological|Tezepelumab|Tezepelumab subcutaneous injection
15895139|NCT03688074|Other|Placebo|Placebo subcutaneous injection
15895140|NCT03688061|Biological|ChAd3-hliNSmut|Attenuated chimpanzee adenovirus (ChAd) vectored vaccine against HCV
15895141|NCT03688061|Biological|MVA-hliNSmut|Modified Vaccinia Ankara (MVA) vectored vaccine against HCV
15895142|NCT03688048|Device|Bright light treatment lamp|Exposure to bright white light (1 hour, 10 000 lux)
15895143|NCT03688048|Device|Sham negative ion generator|Placebo treatment with deactivated negative ion generator (1 hour, audible hum, no ions emitted)
15895144|NCT03688022|Drug|MT-7117|MT-7117
15895145|NCT03688022|Drug|PPI|Proton pump inhibitor
15895146|NCT03688022|Dietary Supplement|Acidic beverage|Acidic beverage
15895208|NCT03687502|Drug|Sulfur hexafluoride lipid-type A microspheres|Contrast Enhanced Ultrasound of the appendix
15914661|NCT03537742|Biological|alirocumab|alirocumab 150mg Subcutaneous
15895149|NCT03687983|Device|GoldenFlow Peripheral Stent System|Performing anaesthetic and pathological angiography according to the standard method, and select appropriate stent specifications according to the contrast results. After 1:1 pre-expansion, the stent system will be imparted into the lesion location, the stent will be distally positioned and released. The Tip head will be reset and the conveyor will be removed. If necessary, local re-expansion can be carried out. Remove the catheter and suture the wound. Postoperative treatment and anticoagulation.
15895150|NCT03687970|Other|Brief Pain Inventory|-A self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. The patient is asked to rate their worst, least, average, and current pain intensity (4 items which generate the PAIN SEVERITY score), list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life (7 items which generate the PAIN INTERFERENCE score) on a 10 point scale.
15895151|NCT03687970|Other|Hospital Anxiety and Depression Scale|"14 item scale with even of the items relating to anxiety and seven relating to depression
~Each item on the questionnaire is scored from 0-3 and this means that a patient can score between 0 and 21 for either anxiety or depression"
15895152|NCT03687970|Other|Neuropathic Pain Symptom Inventory|-The NPSI questionnaire utilized in this study includes eight parameters (i.e., burning pain, squeezing pain, pressure pain, electric shock pain, stabbing pain, tingling pain, pins and needles pain and allodynia [pain provoked by light touch]). Each of the parameters includes recall of the past 24 hours
15895153|NCT03687970|Procedure|Diode Laser fiber type Selective Stimulator|"-Each patient will have an A and C fiber stimulation. Stimulation will be performed on the dorsum of the foot using stimulation previously published parameters to elicit burning pain, which is from activation of C-fibers and pinprick pain from A-fibers"
15895154|NCT03687970|Procedure|Quantitative sensory testing|"Quantitative sensory testing will be performed on the dorsal mid-foot and the ipsilateral shoulder will serve as control area
~Cold and warm detection thresholds, cold and heat pain thresholds, mechanical detection thresholds, and wind-up ratio"
15895155|NCT03687970|Procedure|Conditioned pain modulation efficiency|-Immersion of a hand up to the wrist to a thermostat-controlled water bath maintained at 12 degrees Celsius, and the application of a heat stimulus on the contralateral forearm.
15895156|NCT03687970|Other|Spontaneous pain at baseline on 0-10 Numerical Rating Scale (NRS)|"-The subjects are asked to rate the intensity of their current pain on a 0-10 scale - 0 denoting no pain and 10 denoting worst imaginable pain."
15895162|NCT03687944|Other|Validity and reliability|Test-retest method and concurrent validity
15895163|NCT03687931|Drug|Dexamethasone|Drop
15895164|NCT03687918|Other|Assessment of the performances of QCAD/Lyon in characterizing Gleason ≥7 cancers among contoured lesions|"Principal Objective:
~To assess the performances of QCAD/Lyon (AUC and its 95% confidence interval) in characterizing Gleason ≥7 cancers among the lesions delineated on mpMRI from the Dijon University Hospital.
~Secondary Objectives:
~To compare the diagnostic performance (AUC) of QCAD/Lyon and of the Likert score
~To compare the diagnostic performance (AUC) of QCAD/Lyon and of the PIRADS v2 score
~To define the best combination of quantitative parameters in the Dijon cohort (if different from that defined in Lyon)"
15895165|NCT03687905|Drug|Chloroquine|group1 received chloroquine .
15895166|NCT03687905|Drug|Hydroxychloroquine|Group 2 received hydroxychloroquine
15895167|NCT03687892|Device|continuous Theta Burst Stimulation|Continuous Theta Burst Simulation will be applied in a continuous manner resulting in cortical excitability.
15895168|NCT03687892|Device|intermittent Theta Burst Stimulation|Intermittent Theta Burst Stimulation will be applied in an intermittent manner resulting in cortical inhibition.
15895169|NCT03687879|Other|Questionnaires|Reporting of medical gestures or acts, speech, embarrassing or hurtful attitudes during pregnancy follow-up or during hospitalization outside childbirth, or during childbirth or immediate after birth among women giving birth in one of the 26 maternity hospitals in the period of observation period.
15895170|NCT03687866|Genetic|non invasive prenatal testing|
15895171|NCT03687853|Device|Intrahepatic Arterial Infusion|Intrahepatic Arterial Infusion chemotherapy is one of the most widely used liver tumor treatments.
15895172|NCT03687840|Diagnostic Test|gait analysis|Computerized gait analysis system was used to 3 times to evaluate the spatio-temporal parameters of gait.
15895173|NCT03687827|Drug|Insulin degludec|Participants will receive insulin degludec U100 subcutaneous (s.c.) injection once daily for 36 weeks. Doses will be adjusted according to the fasting self-measured plasma glucose (SMPG) values. Participants earlier treated with one or more allowed oral antidiabetic drug(s) (OAD(s)), should continue their pre-trial OAD(s) treatment throughout the trial.
15895174|NCT03687827|Drug|Insulin glargine|Participants will receive insulin glargine U100 s.c. injection once daily for 36 weeks. Doses will be adjusted according to the fasting SMPG values. Participants earlier treated with one or more allowed OAD(s), should continue their pre-trial OAD(s) treatment throughout the trial.
15895175|NCT03687814|Other|Low FODMAP diet/PEG 3350|Subjects will follow a low FODMAP diet and will take PEG 3350 (Miralax) at 17.7 g (single dose) daily for 4 weeks.
15895176|NCT03687814|Other|sham diet/PEG 3350|Subjects will follow a sham diet and will take PEG 3350 (Miralax) at 17.7 g (single dose) daily for 4 weeks.
15895177|NCT03687801|Behavioral|Online hearing support|The intervention group will follow an online hearing support for five weeks
15895178|NCT03687801|Behavioral|Standard care|The control group will follow standard care during the time the intervention group receives online haring support
15895249|NCT03687086|Other|Program A|Cognitive behavioral therapy type A plus medications prepared in packaging type A.
15895250|NCT03687086|Other|Program B|Cognitive behavioral therapy type B plus medications in packaging type B.
15895251|NCT03687073|Drug|Indole-3-Carbinol|Cohorts 2, 3, & 4: 400 mg PO BID
15895179|NCT03687788|Behavioral|Laughter Therapy|Laughter therapy program was composed of four steps. The first step, which took 10 minutes, had warm-up exercises including gentle stretching and hand clapping. The second step, which included deep breathing exercises and hand clapping, took 5 minutes. The third step involved children's games and laughter exercises. In this step, the most common laughter exercises were milkshake laughter, bugi bugi laughter techniques, lion laughter, cell phone, hot soup laughter, hug laughter, bird laughter, dialogue with nonsense, speech exercises, laugh at one's own aches and pains exercises, argument laughter, brushing teeth and mouthwash exercises. The sessions included a combination of different laughter exercises. This step took 15 minutes. The last step, which included wishes and resting by breathing, took 10 minutes.
15895180|NCT03687775|Other|Stability assessment|Qualitative and quantitative stability assessment
15895181|NCT03687762|Behavioral|Cognitive Therapy (CT)|"The cognitive-restructuring technique will be used to help participants recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via weighing the evidence; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs."
15895182|NCT03687762|Behavioral|Mindfulness Meditation (MM)|Participants will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. A standard script will be implemented by the clinician, and participants will be seated in a comfortable yet alert position.
15895183|NCT03687762|Behavioral|Activation Skills (AS)|Participants will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided.
15895184|NCT03687736|Biological|AbobotulinumtoxinA|AbobotulinumtoxinA treatment in the glabellar region at Baseline and Month 6
15895185|NCT03687723|Device|OCS Heart System|The OCS™ Heart System is a portable organ perfusion and monitoring medical device intended to preserve donor hearts in a near physiologic and beating state prior to transplantation.
15895187|NCT03687697|Biological|Global vs. G-TL vs Cornell's C3 vs Cornell's C1/C2 media|A comparison between Global, G-TL, Cornell's C3, and Cornell's C1/C2 embryo culture media.
15895188|NCT03687684|Drug|TAK-831|TAK-831 Tablets.
15895189|NCT03687684|Drug|Placebo|TAK-831 Matching Placebo Tablets.
15895190|NCT03687671|Other|Animal-assisted therapy|Animal-assisted occupational therapy, animal-assisted physiotherapy and animal assisted speech therapy with different animals. All animals are trained for the specific service with vulnerable patients. There are guinea pigs, rabbits, miniature pigs, sheeps, goats, chicken, dogs, cats and horses.
15895191|NCT03687671|Other|Treatment as usual|Speech therapy, occupational therapy or physiotherapy
15895192|NCT03687658|Behavioral|Laddr|"Laddr is an integrated, personalized, web-based self-regulation assessment and behavior change system. It integrates tools that have been shown to be effective for a wide array of behavioral phenomena ranging from substance use and abuse, mental health, risk-taking, chronic pain management, medication adherence, diet, exercise, diabetes and other chronic disease management, and smoking. The organizational structure, functionality and content within Laddr's system centrally embrace these fundamental aspects of behavior change; thus, the Laddr platform is not diagnosis-specific but rather enables integrated care for any combination of individuals' goals, needs, and preferences."
15895193|NCT03687645|Diagnostic Test|Hyperpolarised MRI|Hyperpolarized (HP) 13C MR is an advanced imaging technique that allows monitoring of dynamic metabolic processes non-invasively. Hyperpolarisation is a process that provides dramatic gains in sensitivity (>10,000) of MRI signal collected from 13C-labelled substrates that can be injected into living systems, allowing in-vivo metabolism for the first time to be observed in real-time using imaging.
15895194|NCT03687632|Biological|ST266|1X ST266 applied in a dose of one drop (30-50 µL) in the study eye for 28 days (112 doses total will be administered).
15895195|NCT03687619|Other|CO-OP|Interventions (from top to down) related to the development of fine-motor skills
15895196|NCT03687619|Other|Conductive Education|Interventions (from down to top) related to the development of fine-motor skills
15895197|NCT03687606|Drug|Human Chorionic Gonadotropin|White freeze-dried cake or powder with specifications of 1000U, 2000U, 5000U.
15895198|NCT03687606|Drug|human menopausal gonadotropin|White freeze-dried cake or powder with specification of 75IU.
15895199|NCT03687593|Device|Legion™ CR Oxinium and CoCr Femoral Implants combined with Legion™/Genesis™ II XLPE High Flex Tibial Inserts|Single arm study, all subjects received the Legion™ CR Femoral Oxinium and CoCr Implant with Legion™/Genesis™ II XLPE Hi-flex Tibial Insert
15895200|NCT03687580|Device|B-Cure Laser Pro|The B-Cure Laser Pro is a portal, non-invasive low-level laser therapy device, that emits light in the near infrared (808nm) over an area of 1X4.5 cm2 with power output of 250mW, and energy dose of 5J/min
15895201|NCT03687580|Device|Sham laser|The sham laser device is externally identical to the B-Cure Laser Pro and emit the same guiding light, but does not emit the therapeutic near infrared rays
15895202|NCT03687567|Procedure|Preimplantation genetic diagnosis|
15895203|NCT03687554|Drug|Venglustat GZ/SAR402671|Pharmaceutical form: Hard Capsule Route of administration: Oral
15895205|NCT03687515|Drug|budesonide|1mg/2ml Pulmicort Respules BIS twice daily
15895206|NCT03687515|Drug|budesonide|nasal spray 256μg BID
15895207|NCT03687515|Drug|Prednisone|oral prednisone 24mg QD
15895252|NCT03687073|Drug|Silibinin|Cohorts 1 & 4: 720mg
15895209|NCT03687489|Device|Abdominal Aortic Aneurysm Stent Graft System|Abdominal aortic bifurcation stent and iliac artery extension stent were preloaded into abdominal aortic bifurcation stent transporter and iliac artery extension stent transporter, respectively. In the operation, the abdominal aorta bifurcation stent and the iliac artery extension stent will be delivered to the corresponding lesion position of the abdominal iliac artery and release. The abdominal aortic bifurcation stent and the iliac artery extension stent will form a whole through docking and thereby reducing the risk of rupture of an infrarenal abdominal aortic aneurysm due to the shock of blood flow.
15895210|NCT03687476|Drug|VTS-270|VTS-270 200 mg/mL administered as described in the arm group description.
15895211|NCT03687463|Drug|Decitabine|Decitabine for injection
15895212|NCT03687450|Behavioral|RISE yoga-based program|The RISE program developed by Kripalu Center for Yoga and Health includes yoga postures, mindfulness practices, meditation, breathing techniques, and education sessions about mindful approaches to daily living. The RISE program will be delivered as a 6-week yoga-based program on-site at Brigham and Women's Hospital in Boston, MA. The program will consist of six 60-90-minute weekly yoga-based RISE classes. Sessions will be lead by experienced instructors from Kripalu Center for Yoga & Health. Subjects in this arm will also be asked to participate in 5-10 minutes of daily home practice with direction from the RISE curriculum.
15895213|NCT03687437|Diagnostic Test|Blood sample|Complete blood count
15895214|NCT03687424|Device|high-flow nasal oxygenation (HFNO)|Experimental HFNO: O2 flow 40L/min, FiO2 40%
15895215|NCT03687424|Device|low-flow nasal oxygenation (LFNO)|Active comparator (LFNO): O2 flow 5L/min, FiO2 40%
15895216|NCT03687411|Procedure|Neuraxial ultrasonography|Ultrasound gel is applied to lower back lumbar spine of patient and placed with an ultrasound probe around the sacral region. The graphical interface of the software integrated with ultrasound machine will help identify the sacrum. The probe is moved in until the L3/4 interspinous space is identified for skin surface marking. Once the longitudinal scan is completed, the investigator will turn the probe 90° clockwise for transverse scan to identify ligamentum flavum.
15895217|NCT03687398|Diagnostic Test|genetic testing with nanoclonal technique|endometrial sampling
15895218|NCT03687385|Device|high-flow nasal oxygenation (HFNO)|Experimental HFNO: O2 flow 40L/min, FiO2 40%
15895219|NCT03687385|Device|low-flow nasal oxygenation (LFNO)|Active comparator LFNO: O2 flow 5L/min, FiO2 40%
15895220|NCT03687372|Drug|A-101|hydrogen peroxide topical solution 45%
15895221|NCT03687372|Other|vehicle|vehicle as a topical solution
15895222|NCT03687359|Other|Standard of care|Treatment as per standard practice
15895223|NCT03687333|Drug|ALGLUCOSIDASE ALFA (MYOZYME)|"Pharmaceutical form: cake or powder for injection
~Route of administration: intravenous infusion"
15895224|NCT03687320|Device|B-Cure Pro|The B-Cure laser Pro is a portal, non-invasive, low level laser therapy device, that emits light in the near infrared (808nm) over an area of 1X4.5 cm2 with power output of 250mW, and energy dose of 5J/min.
15895225|NCT03687320|Device|Sham|The sham device is externally identical to the B-Cure Pro and emit the same guiding light, but does not emit the therapeutic near infrared rays.
15895226|NCT03687294|Device|enzyme linked immunosorbent assay (ELISA)|ELISA measure MYB in tissue biopsy in benign and malignant salivary gland tumors
15895227|NCT03687281|Other|Survey|"The questionnaire consists of three parts:
~knowledge assessment;
~socio-demographic, medical and lifestyle data;
~use of Chemsex."
15895228|NCT03687268|Drug|Naloxone HCl PR tablets|oral administration
15895229|NCT03687268|Drug|Placebo Oral Tablet|Placebo
15895230|NCT03687255|Drug|cefepime/AAI101 combination|cefepime 2 g / AAI101 500 mg
15895231|NCT03687255|Drug|Piperacillin/tazobactam|piperacillin 4 GM / tazobactam 500 MG
15895232|NCT03687242|Drug|SPR001|Open label SPR001
15895233|NCT03687229|Diagnostic Test|A)microribonucleic acid-122(miRNA-122), B) Hepatitis C virus Real Time Polymerase chain Reaction (HCV RT-PCR)|measure level of serum micro ribonucleic acid -122 and insulin resistance in chronic hepatitis C patients using real time polymerase chain reaction
15895234|NCT03687229|Diagnostic Test|A)fasting serum glucose, B)Fasting serum insulin|measure level of insulin resistance
15895235|NCT03687216|Procedure|HVPG-guided therapy|"The baseline HVPG measurement is performed. According to the result, patients with an HVPG over 20 mmHg will be receive transjugular intrahepatic portocaval shunt (TIPS) .
~Patients with an HVPG below 20 mmHg will be treated by endoscopic variceal ligation (EVL) plus nonselective beta blocker (NSBB) propranolol until treatment fails."
15895236|NCT03687216|Procedure|Routing Therapy|Without HVPG measurement, patients receive endoscopic variceal ligation (EVL) plus nonselective beta blocker (NSBB) propranolol.
15895237|NCT03687203|Diagnostic Test|Functional Activities Questionnaire|The FAQ is an economic and easy to apply activity of daily living scale. We aim to validate the prognostic value of novel FAQ scores, which differentiate cognitive- from motor-driven activity of daily living function.
15895238|NCT03687190|Behavioral|Tai chi|participants were required to receive hospital-based Tai chi training at least once a month, and home-based Tai chi exercise at least three times a week over the next 2 years
15895239|NCT03687190|Drug|conventional medicine|participants without Tai chi training still received routine conventional medicine
15895240|NCT03687177|Other|With visual cue and nurses informed|Using visual cue or no visual cue with to estimate the angle of elevation of the head of intubated patients with prevention of nurse
15895241|NCT03687177|Other|Without visual cue and nurses informed|Not using visual cue or no visual cue with to estimate the angle of elevation of the head of intubated patients with prevention of nurse
15895242|NCT03687164|Other|Group Medical Visits|Patients will attend group medical visits in groups of 6 -10. Groups will have a set curriculum and patients will meet with the provider one on one to assess individual needs at each session.
15895243|NCT03687151|Other|non intervention / observationnal|non intervention / observationnal
15895244|NCT03687138|Other|24h urin sample|The samples will analyzed by proteomic techniques
15895245|NCT03687125|Drug|Tinostamustine|Participants received tinostamustine IV injection.
15895246|NCT03687125|Procedure|Autologous Stem Cell Transplant (ASCT)|Undergo autologous stem cell transplant
15895247|NCT03687112|Other|non ontervention / observational study|non intervention
15895248|NCT03687099|Other|no intervention|Histological samples from 10 GBM removed from patients with long-term survival and 10 GBM removed from patients with short-term survival
15895254|NCT03687060|Behavioral|Knowledge assessment|Investigators will conduct semi-structured interviews with medical directors, clinical leadership and all participating physicians to gain insight on knowledge about and barriers to prescribing statins for people living with HIV. People living with HIV will participate in focus groups.
15895255|NCT03687060|Behavioral|Education Intervention|"Education intervention will be adapted from the the findings of these interviews and focus groups.
~Clinics will be randomized to receive the education intervention and feedback implementation strategies at different times.
~Medical directors and providers will receive a brief educational intervention about cardiovascular disease risk in people living with HIV. Providers will additionally receive a web-based survey before and after the education intervention.
~Patients will receive pamphlets tailored to the effects of cardiovascular disease treatment for people living with HIV."
15895256|NCT03687060|Behavioral|Provider Feedback|Six months after the education intervention, providers will receive monthly emails with feedback regarding their rates of prescribing statins, with language targeted at increasing motivation to prescribe by leveraging social norms and self-image.
15895257|NCT03687047|Device|New complete dentures|Preliminary impressions using stock trays and impression compound; primary casts fabricated to make custom trays for definitive impressions; definitive impressions using zinc oxide eugenol impression paste; definitive impressions poured with type III dental stone to obtain mastercasts; jaw relations will be recorded, and the casts will be mounted on the articulator; the artificial acrylic resin teeth will be arranged, esthetics will be verified, and the trial dentures will be flasked and polymerized (72°C per 12 hours). The dentures will be finished and polished for insertion and follow-up.
15895258|NCT03687034|Drug|Temozolomide|Standard-of-care chemotherapy for patients with glioblastoma includes concurrent radiation therapy (2 Gy per day for a total of 60 Gy) and temozolomide (75 mg per square meter of body- surface area per day, seven days per week from the first to the last day of radiotherapy), followed by six cycles of adjuvant temozolomide (150 to 200 mg per square meter for five days during each 28-day cycle).
15895259|NCT03687034|Device|Optune|Standard-of-care treatment for glioblastoma includes alternating electric-field therapy, or Optune, as a Category 1 treatment in conjunction with temozolomide after maximal safe resection and completion of radiation therapy.
15895260|NCT03687021|Drug|Progesterone|Different routes of administration of progesterone; Whether there is endometriosis
15895261|NCT03687008|Behavioral|Cognitive Computer Based Intervention|25 sessions [each 30-45 minutes, 5 days a week / for 5 weeks], supervised by trained coaches
15895262|NCT03686982|Other|Active Nitrate Bar|Bar containing Nitrate, L-citrulline; epicatechin; vitamin C and glutathione
15895263|NCT03686982|Other|Placebo Bar|No active ingredients
15895264|NCT03686969|Drug|Octanorm|Octanorm 0.5g/kg/week
15895265|NCT03686969|Other|Placebo|Placebo
15895266|NCT03686956|Other|Physiotherapy treatment|Physiotherapy treatment consisted of pelvic floor exercises assisted by manometric biofeedback. In addition, active lumbopelvic stabilization exercises, including the contraction of pelvic floor muscles was performed in supine, plank and quadruped position.
15895267|NCT03686943|Other|Family pharmacy|Observation of the family pharmacy in elderly group
15895268|NCT03686930|Drug|Cohort 1 - FP-045 oral solution|FP-045 given orally with dose escalation between cohorts, based on emerging safety and pharmacokinetic (PK) data. Cohorts 2 and 3 doses to be based on the safety, tolerability, and PK data generated in the study. The dosing duration for cohorts 1-3 will be 7 consecutive days.
15895269|NCT03686930|Drug|Cohort 2 - FP-045 oral solution|FP-045 given orally with dose escalation between cohorts, based on emerging safety and pharmacokinetic (PK) data. Cohorts 2 and 3 doses to be based on the safety, tolerability, and PK data generated in the study. The dosing duration for cohorts 1-3 will be 7 consecutive days.
15895270|NCT03686930|Drug|Cohort 3 - FP-045 oral solution|FP-045 given orally with dose escalation between cohorts, based on emerging safety and pharmacokinetic (PK) data. Cohorts 2 and 3 doses to be based on the safety, tolerability, and PK data generated in the study. The dosing duration for cohorts 1-3 will be 7 consecutive days.
15895271|NCT03686930|Drug|Placebo (for FP-045 oral solution)|Participants (cohorts 1-3) will receive FP-045 oral solution matching placebo.
15895272|NCT03686917|Other|CHAT-P|Survey
15895273|NCT03686904|Drug|Benzalkonium Gel|antibiofilm solution (BlastX) topical wound gel
15895274|NCT03686904|Other|standard of care topical gel|standard of care topical gel (hydrocolloid topical gel)
15895275|NCT03686904|Procedure|Debridement|Removing dead tissue from infected wound (in clinic)
15895276|NCT03686904|Drug|benzalkonium irrigation|washing and lavaging in clinic with benzalkonium irrigation
15895277|NCT03686904|Other|Saline Irrigation (SOC Irrigation)|Normal Saline Irrigation (SOC Irrigation)
15895278|NCT03686891|Other|Skin prick tests with four native legumes|Skin prick tests with four native legumes
15895279|NCT03686878|Drug|Lifitegrast|Lifitegrast used twice a day
15895280|NCT03686865|Device|dental implants|extraction sockets regenerated with xenograft
15895281|NCT03686852|Other|same medications but different dosages|The main difference between the groups is due to the different dose of r-FSH which will be given to pa-tients after the 7 days of CFA; namely that patients who need additional r-FSH following corifollitropin-alfa will be randomized on day 8 of the stimulation into 3 study groups. In group A, B and C, ovarian stimula-tion with Corifollitropin alfa (Elonva®, MSD) will be used for ovarian stimulation, followed by 50IU (Group A), 150IU (Group B) or 250IU (Group C) of recFSH (Puregon®, MSD)
15895282|NCT03686839|Behavioral|SMR neurofeedback training to MCI|SMR neurofeedback training consisted to increase the synaptic strengths and sensitivity within this network. Electroencephalography signals for SMR/theta ratio training was recorded at channel Cz according to the International 10-20 system. Theta rhythm was also recorded and, in this case, SMR was stimulated while theta waves were suppressed. A 32 channels system (EEGDigitrack Biofeedback plus module, Inc Elmiko Medical) was used for SMR/theta neurofeedback training.
15895283|NCT03686826|Procedure|Acquisition of MEP und SSEP|Acquisition of MEP und SSEP at two different time points within 1 to 30 days
15895284|NCT03686813|Drug|Sildenafil Citrate|Oral sildenafil, 50 mg
15895285|NCT03686813|Drug|Placebo Oral Tablet|Placebo
15895286|NCT03686800|Device|Rivelin® plain patches|The comfort and adherence of Rivelin® plain patches in Vulva Lichen Sclerosus patients
15895287|NCT03686787|Drug|Tranexamic Acid|A split face study of oral tranexamic acid in combination with laser treatment
15895288|NCT03686774|Drug|Memantine|"Women provide written informed consent prior to their participation in the study, during their Anesthesiology visit. After baseline assessments (15 days before surgery: Day 0 - 15) of pain intensity, cognitive, quality of life and quality of sleep questionnaires, participants will be randomized in two parallel groups: memantine (n=75) or usual care (n=75). Memantine will be given orally for four weeks starting two weeks before surgery. Endpoints will be assessed 15 days (Day 0 + 15), 3 months (Day 0 + 3 months), 6 months (Day 0 + 6 months) et 12 months (Day 0 + 12 months) post-mastectomy. In order to maintain a good compliance and to verify that women do not develop adverse events, patients will be called once a week by phone. A booklet for monitoring will be completed daily by the patient for 3 months from the day of surgery."
15895289|NCT03686774|Other|no memantine|"Concerning the comparator group, patients will be followed in the same way as those in the memantine group except that they will not receive the study treatment"
15895290|NCT03686761|Procedure|A Involvement with the osteotomy site of the surgery|A Involvement with the osteotomy site of the surgery
15895291|NCT03686748|Behavioral|Two-point discrimination training|Patients will undergo multiple sessions of two-point discrimination training.
15895292|NCT03686748|Behavioral|One-point discrimination training|Patients will undergo multiple sessions of one-point discrimination training.
15895293|NCT03686735|Other|5 anchors and numbers|"How helpful was this visit? 0 This visit was not helpful at all
~1 2-3 There were many ways it could have been better 4 5 Neither useless nor helpful visit 6 7-8 Exceptionally helpful visit 9 10 One of the most helpful doctor visits I have ever had"
15895294|NCT03686735|Other|5 anchors and no numbers|How helpful was this visit? This visit was not helpful at all There were many ways it could have been better Neither useless nor helpful visit Exceptionally helpful visit One of the most helpful doctor visits I have ever had
15895295|NCT03686735|Other|Visual analog scale with 3 anchors and numbers|How helpful was this visit? 0 neutral/50 100 Least helpful visit Most helpful visit
15895296|NCT03686735|Other|Visual analog scale with 3 anchors and no numbers|"How helpful was this visit?
~This visit was not Neither useless nor One of the most helpful doctor helpful at all helpful visit visits I have ever had"
15895297|NCT03686722|Drug|Metformin|Metformin is used primarly in treatment of diabetes type II
15895298|NCT03686722|Drug|Daclatasvir|Daclatsvir is a direct acting antiviral drug
15895299|NCT03686709|Diagnostic Test|Post therapy PET/CT Imaging|whole-body PET/CT following Y90 radioembolization
15895300|NCT03686696|Drug|Beta blocker|Patients randomized to beta-blockade will be administered the assigned treatment during the rest of the hospital stay and receive a prescription for the continued use at discharge. The treating physician is encouraged to aim for target dose or highest tolerable dose for the drug. Patients will be encouraged to continue the use of the randomized treatment following discharge until contraindications.
15895301|NCT03686696|Drug|ACEI|Patients randomized to ACE inhibitor will be administered the assigned treatment during the rest of the hospital stay and receive a prescription for the continued use at discharge. The treating physician is encouraged to aim for target dose or highest tolerable dose for the drug. Patients will be encouraged to continue the use of the randomized treatment following discharge until contraindications.
15895302|NCT03686696|Drug|ARB|Patients randomized to Angiotensin receptor blockers will be administered the assigned treatment during the rest of the hospital stay and receive a prescription for the continued use at discharge. The treating physician is encouraged to aim for target dose or highest tolerable dose for the drug. Patients will be encouraged to continue the use of the randomized treatment following discharge until contraindications
15895303|NCT03686683|Biological|sipuleucel-T|Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
15895304|NCT03686657|Drug|Metformin|1000 mg metformin-HCL XR once-a-day or maintenance dose of metformin for 26 weeks
15895305|NCT03686657|Drug|Val, Cel and Met XR Low|500 mg metformin-HCL XR plus 100 mg celecoxib once-a-day in the morning and 160 mg valsartan 6 hours later once-a-day in the afternoon for 26 weeks.
15895306|NCT03686657|Drug|Val, Cel and Met XR High|1000 mg metformin-HCL XR plus 200 mg celecoxib once-a-day in the morning and 320 mg valsartan once-a-day 6 hours later in the afternoon for 26 weeks.
15895307|NCT03686644|Procedure|Wearing of night splint ankle foot orthoses (phase A)|"Children wearing of night splint ankle foot orthoses during 6, 7 or 8 days according to the position of inclusion.
~An ultrasound of the leg muscles will be realized every morning after removing night splint.
~An isokinetic dynamometer will be realize at the beginning of the study and at the end of each phase.
~measure of quality of night sleeping will be measured by Visual Analog Scale (VAS) results."
15895308|NCT03686644|Procedure|No wearing of night splint ankle foot orthoses (phase B)|"Children no wearing of night splint ankle foot orthoses during 6, 7 or 8 days according to the position of inclusion.
~An ultrasound of the leg muscles will be realized every morning after removing night splint.
~An isokinetic dynamometer will be realize at the beginning of the study and at the end of each phase.
~measure of quality of night sleeping will be measured by Visual Analog Scale (VAS) results."
15895309|NCT03686631|Behavioral|Smartphone Arm|"The smartphone arm will have an associated smartphone application, available in kiosk mode, that will remind and encourage patient to utilize the spirometer and provide a gamified application for that patient to do so."
15895310|NCT03686618|Drug|Secretin|Drug to stimulate pancreatic secretion
15895311|NCT03686605|Other|Thai version of the Edmontom Symptom Assessment System (ESAS)|Screening and diagnostic questionaire for depression
15895312|NCT03686592|Other|Measurement of body awareness|Questionnaires+ interviews
15895313|NCT03686579|Radiation|chest trauma|clinical and radiological study
15895314|NCT03686566|Drug|13C-glucose|Includes standard pre-operation nursing care, 13C-glucose infusion and finger stick/IV glucose checks and storage of blood sample approximately every 30 minutes
15895315|NCT03686566|Other|No glucose infusion|Only includes standard pre-operation nursing care
15895316|NCT03686553|Other|laboratory-based data collection|laboratory-based surveillance of SSI
15895317|NCT03686540|Procedure|ExtraCorporeal Membrane Oxygenation (ECMO)|The objective of this study is to determine the average cost of stay of a patient supported by ExtraCorporeal Membrane Oxygenation from the point of view of the hospital facility, during the hospitalization in which the ECMO was implanted.
15895318|NCT03686527|Procedure|stenosis aortic valve|"The exams to be realized :
~a clinical examination with blood pressure
~a 12-lead surface electrocardiogram
~a standard biological assessment including NTproBNP (Brain Natriuretic Peptide)
~Transthoracic echocardiography at baseline and 12 months after the aortic valve intervention on the (according to recommendations)
~a cardiac MRI looking for fibrosis myocardial"
15895319|NCT03686514|Biological|Seasonal influenza vaccine|The FDA-approved, quadrivalent seasonal influenza vaccine that will be administered contains four distinct strains, two IAVs and two influenza B viruses (IBVs)
15895320|NCT03686501|Drug|PF-06412562|Healthy Volunteers recruited for the study will undergo a single dose of PF-06412562 and will undergo two [18F]MNI-968 injections
15895321|NCT03686488|Drug|TAS 102|TAS 102 35 mg will be administered orally twice daily every 2 weeks.
15895322|NCT03686488|Drug|Ramucirumab 10 MG/ML Intravenous Solution [CYRAMZA]|Ramucirumab 8 miligrams/kilogram will be administered as a 60 minute intravenous (IV) infusion every 2 weeks.
15895323|NCT03686475|Other|Biodentine|pulpotomy for primary molars , clinical and radiographic evaluation at 1,3,6 and 12month
15895324|NCT03686475|Other|MTA pulpotomy|MTA pulpotomy
15895325|NCT03686462|Device|Virtual reality-based interactive treadmill training|During the 30-min training session, VR based interaction and feedback will be provided; the foot location will be visualized in the VR screen (semi-immersive condition), the obstacles will be seen in the screen from which subjects has to avoid, gait speed will be visualized, slopes of the treadmill will be changed according to the slope changes in VR and distractors will be added. Dual tasks will also be provided. Subjects in this group will receive a 30min/session, 3 sessions/week for 4 weeks, the total of 12 sessions of VR-based training.
15895326|NCT03686462|Device|Treadmill training without VR-based interaction|Treadmill training without VR-based interaction
15895327|NCT03686449|Procedure|Non-cultured Autologous Keratinocyte Suspension|New method for treatment of post-burn raw area
15895328|NCT03686449|Procedure|Adipose-Derived Stem cell-Keratinocyte Suspension|New method for treatment of post-burn raw area
15895329|NCT03686449|Procedure|Split skin graft|Traditional method for treatment of post-burn raw area
15895330|NCT03686436|Device|ocular coherence tomography|imaging by ocular coherence tomography
15895331|NCT03686410|Behavioral|Web-based Therapeutic Educational Intervention|"The subjects assigned to this group will follow a web-based therapeutic educational intervention on pain and poor sleep quality.
~All the subjects assigned to this intervention will have free access to the website from any device with internet access and will be able to consult it as many times as they wish during the intervention. The intervention will last for four weeks."
15895332|NCT03686410|Other|Conventional Treatment|"The subjects assigned to this condition will continue with their usual treatment is based on the recommendations of the clinical practice guideline for the treatment of fibromyalgia Guide of Fibromyalgia developed by the Department of Health of the Generalitat de Catalunya and the Servei Català de Salut."
15895333|NCT03686397|Drug|SVT-15652|1 vial twice daily
15895334|NCT03686397|Drug|Placebo|1 vial twice daily
15895335|NCT03686384|Drug|SVT-15652|1 vial twice daily
15895336|NCT03686384|Drug|Placebo|1 vial twice daily
15895337|NCT03686371|Procedure|posterior surgery for spinal arthrodesis|posterior surgery for spinal arthrodesis
15895338|NCT03686358|Procedure|Renal artery angioplasty|"Patients meeting the inclusion criteria were selected from the medical records of renal angioplasty performed at the Rennes University Hospital between 01/01/2010 and 12/31/2013. Each selected patient will receive a notice by mail of information. In the absence of opposition from them within a two weeks, the processing of their data will begin :
~Evaluation of the results at 3 years of renal angioplasty on atherosclerotic stenosis performed at Rennes University Hospital
~Evaluation of indications of renal angioplasty on stenosis atherosclerosis performed after 2009 at Rennes University Hospital
~Identification of prognostic factors"
15895339|NCT03686345|Drug|Midostaurin|Midostaurin associated with standard chemotherapy in patients with core-binding factor leukemia
15895340|NCT03686332|Drug|Arm A: Atezolizumab and Radiotherapy|patients will receive atezolizumab, 1200 mg, every 3 weeks, by IV infusion. Patients in group A will additionally receive 33 fractions of 1.5 (locoregional affected lymph nodes) and 1.8 Gy (tumor+margin) irradiation, concurrently with atezolizumab treatment.
15895341|NCT03686332|Drug|Arm B: Atezolizumab|patients will receive atezolizumab, 1200 mg, every 3 weeks, by IV infusion.
15895342|NCT03686319|Other|Reflexology|Reflexology: foot massage
15895343|NCT03686306|Drug|Sildenafil|"Sildenafil citrate 140 mg/day (single morning oral dose of 140 mg) for a total duration of 24 weeks. + advice to walk for a total duration of 6 months.
~Treatment will be proposed in addition to optimal treatment (Antiplatelet + Lipid Lowering Drugs + AT2 antagonists / ACE Inhibitors; unless contra-indicated) + advice to walk."
15895344|NCT03686306|Drug|Placebo|"Placebo (single morning oral dose) + advice to walk for a total duration of 24 weeks.
~Treatment will be proposed in addition to optimal treatment (Antiplatelet + Lipid Lowering Drugs + AT2 antagonists / ACE Inhibitors; unless contra-indicated) + advice to walk."
15895345|NCT03686293|Other|Standardized breakfast|One tablet of paracetamol (500 mg) and a glass of water (150 mL) is consumed followed by a breakfast consisting of white bread, butter, jam, and juice (300 mL) and
15895346|NCT03686280|Other|Clinical evaluation|A clinical evaluation of the balance and the walk: is carried out by one of the coordinating physiotherapists of the center where the patient realizes his rehabilitation. The latter performs, according to the functional level of the patient, the following tests: Berg balance scale, FAC, PASS, TUG, 10MWT, 6MWT, paretic lower limb traction index , LBA, SSA and SSV, measurement of spasticity and sensitivity(D0, D30 and D90)
15895347|NCT03686280|Other|Intervention - with Robot|16 sessions of 45 minutes of reeducation with robot of the walk and the procedure to follow with the same patient for the same phase of rehabilitation of the balance and the walk or of several of them (Annex 3b), at the rate of 3 at 5 sessions per week, for 4 weeks and according to predefined exercises
15895348|NCT03686280|Other|Intervention - without Robot|16 sessions of 45 minutes of reeducation without robot of the walk and the procedure to follow with the same patient for the same phase of rehabilitation of the balance and the walk or of several of them (Annex 3b), at the rate of 3 at 5 sessions per week, for 4 weeks and according to predefined exercises
15895757|NCT03683030|Device|Radiofrequency Ablation|RF ablation using the multi-electrode radiofrequency balloon catheter
15895349|NCT03686280|Other|quality of life assessment|A quality of life assessment: SIS questionnaire completed by the patient, the results of which will be reported in the observation book by the coordinating physiotherapist who carried out the evaluations described above. (D0, D30 and D90)
15895350|NCT03686280|Other|An assessment of patient acceptance of robotic rehabilitation|An assessment of patient acceptance of robotic rehabilitation (for patients in the robot group): self-questionnaire to be filled in by the patient (before carrying out the gait tests in order to avoid influence the results) (D30 ans D90)
15895351|NCT03686280|Other|cognitive assessment|An evaluation of cognitive functions (between D0 and D30): research dysexual cognitive-behavioural syndrome, hemineglect visio-spatial, memory disorders. Done by a doctor evaluator.
15895352|NCT03686280|Other|An evaluation of how to use the robot|An evaluation of the robot's modalities of use (for patients in the robot group): time of use, distance travelled, walking speed, exercise duration, percentage of regulated suspension, number of breaks, average length of breaks, total length of breaks. (D30)
15895353|NCT03686267|Other|opaqued titanium abutments|masking metallic color of titanium abutments by opaque porcelain
15895354|NCT03686267|Other|lithium disilicate coping (high opacity)|masking metallic color of titanium abutments using lithium disilicate copings
15895355|NCT03686267|Other|titanium abutment with no color masking|color masking methods are avoided in this arm
15895356|NCT03686254|Combination Product|RFA, bevacizumab and second-line chemotherapy|Navigated by CT-ultrasound merged images, RFA is taken in the experimental arm at the first day of the first cycle during the second-line therapy. Bevacizumab is given to patients in all arms every 2 weeks (5mg/kg) or 3 weeks (7.5mg/kg), intravenous drip(VD). The second-line chemotherapies include FOLFIRI [Irinotecan 180 mg/m2 D1+Calcium folinatc 400 mg/m2 or Calcium Levofolinate 200 mg/m2 D1+5-FU 400 mg/m2 D1, 2400 mg/m2 D1-2(46-48h), q2W] or irinotecan monotherapy (125 mg/m2 D1, 8, q3W or 180 mg/m2 D1, q2W), mFOLFOX6 [Oxaliplatin 85 mg/m2 D1+Calcium folinatc 400 mg/m2 or Calcium Levofolinate 200 mg/m2 D1+5-FU 400 mg/m2 D1, 2400 mg/m2 D1-2(46-48h), q2W] or CapeOX (Oxaliplatin 130 mg/m2 D1+Capecitabine 1000 mg/m2 Bid D1-14, q3W)，or irinotecan+oxaliplatin (Oxaliplatin 85 mg/m2 D1+Irinotecan 200 mg/m2 D1, q3W). Among these strategies, the treatment cycle of FOLFIRI, irinotecan monotherapy and mFOLFOX6 is two weeks, while three weeks in CapeOX and irinotecan + oxaliplatin.
15895357|NCT03686254|Drug|Bevacizumab and second-line chemotherapy|Bevacizumab is given to patients in all arms every 2 weeks (5mg/kg) or 3 weeks (7.5mg/kg), intravenous drip(VD). The second-line chemotherapies include FOLFIRI [Irinotecan 180 mg/m2 D1+Calcium folinatc 400 mg/m2 or Calcium Levofolinate 200 mg/m2 D1+5-FU 400 mg/m2 D1, 2400 mg/m2 D1-2(46-48h), q2W] or irinotecan monotherapy (125 mg/m2 D1, 8, q3W or 180 mg/m2 D1, q2W), mFOLFOX6 [Oxaliplatin 85 mg/m2 D1+Calcium folinatc 400 mg/m2 or Calcium Levofolinate 200 mg/m2 D1+5-FU 400 mg/m2 D1, 2400 mg/m2 D1-2(46-48h), q2W] or CapeOX (Oxaliplatin 130 mg/m2 D1+Capecitabine 1000 mg/m2 Bid D1-14, q3W)，or irinotecan+oxaliplatin (Oxaliplatin 85 mg/m2 D1+Irinotecan 200 mg/m2 D1, q3W). Among these strategies, the treatment cycle of FOLFIRI, irinotecan monotherapy and mFOLFOX6 is two weeks, while three weeks in CapeOX and irinotecan + oxaliplatin.
15895358|NCT03686241|Procedure|Tibiotalocalcaneal (TTC) arthrodesis|Tibiotalocalcaneal (TTC) arthrodesis with a novel dynamic compression intramedullary nail.
15895359|NCT03686241|Device|DynaNail|Utilization of a novel dynamic compression pseudoelastic intramedullary nail
15895360|NCT03686228|Procedure|PB-MNC therapy|The patients will receive subcutaneous injection of Granulocyte colony stimulating factor (G-CSF) for 3 day. The mononuclear cell will be collected by blood cell separator. The 120 cc of cell solution will be injected into calf or thigh of ischemic limb (1cc per site) with needle no. 25 gauge. Patients will receive ASA 81 mg once daily and wound care and pain killer drug
15895361|NCT03686228|Drug|No-PB-MNC therapy|Patients will receive ASA 81 mg once daily and wound care and pain killer drug
15895363|NCT03686202|Biological|MET-4|Microbial Ecosystem Therapeutics (MET) is a new treatment approach developed as an alternative to fecal transplantation. Unlike donor stool used in fecal transplants, which are incompletely characterised complex communities of microbes and associated metabolites and fecal material, MET consists of a defined mixture of pure live cultures of intestinal bacteria isolated from a stool sample of a healthy donor.
15895364|NCT03686189|Device|Iliac Bifurcation Stent Graft System|Device placement after preoperative preparation. For patients with the aortoiliac aneurysm, the placement of short-bodied iliac artery bifurcation stent graft combined with the placement of the abdominal aortic stent graft, or the placement of long-bodied iliac artery bifurcation stent graft combined with the placement of the abdominal aortic stent graft are recommended.
15895365|NCT03686176|Other|Virtual Reality|A child life specialist will fit the patient with the goggles, select a game, and initiate play once the medical procedure begins.
15895366|NCT03686163|Drug|Nerve Growth Factors|the experimental group patients will receive NGF 20ug/d intranasally for 2 weeks
15895367|NCT03686163|Drug|normal saline|The Placebo Comparator group patients will receive nomral saline 20ug/d intranasally for 2 weeks
15895368|NCT03686150|Dietary Supplement|Vitamin D3 oral regimen|Vitamin D3 oral regimens supplementation
15895369|NCT03686137|Other|Data collection|Colelction of pre-operative, surgical and post-surgical data
15895370|NCT03686124|Biological|IMA203 Product|The cell dose will be based on viable CD3+CD8+ HLA-Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula.
15895371|NCT03686124|Device|IMADetect®|IMADetect® is developed as a companion diagnostic to aid in selecting patients with relapsed and/or refractory solid cancers who might be eligible for enrollment in Immatics clinical trials. IMADetect® is intended for investigational use only.
15895372|NCT03686124|Drug|Atezolizumab|Atezolizumab will be given post IMA203 infusion, after hematologic recovery is achieved, for up to a year after IMA203 infusion.
15895373|NCT03686111|Diagnostic Test|oocytes collect|After stimulation, an echo-guided oocyte puncture is performed under anesthesia
15895374|NCT03686098|Dietary Supplement|Dietary soy|Soy isoflavones delivered through diet, assisted by a detailed food guide for locally available soy-based foods.
15895375|NCT03686098|Dietary Supplement|Soy Supplement|Soy isoflavones delivered in extracted form
15895376|NCT03686085|Drug|Dinoprostone 3 mg|1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the study nurse 6 hours before IUD insertion.
15895378|NCT03686072|Procedure|Cataract surgery with endoscopic goniosynechialysis|Phacoemulsification was performed first. Immediately after implantation of the IOL, a 23G ophthalmic endoscope (OE) probe was inserted into the anterior chamber to visualize the PAS through the main incision and side incision. A viscoelastic agent and a blunt iris spatula were used to release the areas where where PAS existed.
15895379|NCT03686059|Drug|Omega 3|daily intake of 250 mg
15895380|NCT03686059|Device|punctal plug|punctal plug will be inserted in inferior punctum
15895381|NCT03686046|Other|Exploratory use|Participants will be accompanied by a researcher while wearing the open-source speech processing platform as a hearing aid - adjusted to their needs using a widely accepted Fitting prescription. Using a hand-held controller, they will readjust to their liking as the acoustic conditions change. After returning to the laboratory, they will complete speech perception tests using under their self-selected amplification conditions and respond to a structured interview dealing with perceived performance of the device and its acceptability as a hearing aid during possible field studies.
15895382|NCT03686033|Drug|Placebo|Participants will receive E2082-matched placebo tablets orally.
15895383|NCT03686033|Drug|E2082|Participants will receive E2082 tablets orally.
15895384|NCT03686020|Diagnostic Test|Enzyme Linked Immunosorbent assay (ELISA)|measure serum and salivary CYFRA21-1 levels in all included participants using Enzyme Linked Immunosorbent assay (ELISA)
15895385|NCT03686007|Other|Informational Intervention|Receive MSM intervention handbook
15895386|NCT03686007|Other|Informational Intervention|Receive MSM intervention research nurse coaching
15895387|NCT03686007|Other|Informational Intervention|Receive ASCO print materials
15895388|NCT03686007|Other|Informational Intervention|Receive CRA assistance
15895389|NCT03686007|Other|Media Intervention|View the MSM intervention videos
15895390|NCT03686007|Other|Media Intervention|View ASCO Cancer.net videos
15895391|NCT03686007|Other|Quality-of-Life Assessment|Ancillary studies
15895392|NCT03686007|Other|Questionnaire Administration|Ancillary studies
15895393|NCT03685981|Other|Incentives mailer|Participants will receive a letter that describes the incentives provided by their health plan for following appropriate preventative care guidelines.
15895394|NCT03685968|Device|Video laryngoscopes|Patients were randomized into one of the three groups through a computer generated randomization schedule. Patients in group A (N= 75) will be intubated using the GlideScope® AVL, patients in group B (N= 75) will be intubated using the King Vision Channeled VL; patients in group C (N=75) will be intubated using the King Vision Video Laryngoscope with Standard (non-channeled) Blade. Patients will only be tested with one device. All patients will be intubated using a conventional ETT.
15895395|NCT03685955|Biological|Amniotic membranes|Amniotic membranes will be employed during participant's genitourinary reconstruction
15895396|NCT03685942|Device|active light therapy (LUMINETTE®)|light therapy on a portable light visor device
15895397|NCT03685942|Device|placebo light therapy|placebo portable light visor device
15895398|NCT03685929|Procedure|Punch skin biopsy|Two punch biopsies will be performed in each patient, one at the border of the skin lesion, and one at the adjacent healthy skin. A disposable biopsy punch of 4 mm will be used. A biopsy punch is a small circular blade (like an apple corer) which is rotated into the skin to obtain a cylindrical specimen. Local anaesthesia will be applied and the circular wound will be closed by a single suture. Sutures will be removed after one week.
15895399|NCT03685916|Other|Control|Plain rice with plain water
15895400|NCT03685916|Other|Cumin Rice|Cumin rice with plain water
15895401|NCT03685916|Other|Cumin Drink|Cumin drink with plain rice
15895402|NCT03685916|Other|Cornsilk Rice (Low dose)|Low dose cornsilk rice with plain water
15895403|NCT03685916|Other|Cornsilk Rice (High dose)|High dose cornsilk rice with plain water
15895404|NCT03685916|Other|Cornsilk Drink (Low dose)|Low dose cornsilk drink with plain rice
15895405|NCT03685916|Other|Cornsilk Drink (High dose)|High dose cornsilk drink with plain rice
15895406|NCT03685916|Other|Tamarind Rice|Tamarind rice with plain water
15895407|NCT03685916|Other|Tamarind Drink|Tamarind drink with plain rice
15895408|NCT03685903|Device|CapsoCam® Plus (SV-3) capsule endoscope|Endoscope Capsule
15895409|NCT03685890|Drug|Nivolumab|One infusion of nivolumab (Opdivo®) 480mg (flat dose) in NaCl (Natriumklorid Baxter Viaflo, 9 mg/ml) during 60 minutes
15895410|NCT03685890|Procedure|Isolated limb perfusion (ILP)|Patients will be treated with ILP according to clinical routine at each separate site. The procedure is performed under general anaesthesia. The major artery and vein of the limb is catheterized, and a tourniquet is placed proximally on the limb. Continuous leakage monitoring is performed. The perfusate is heated to 40C and after ensuring steady state, melphalan (Alkeran®) at a dose of 13 mg/L (upper limb) or 10 mg/L (lower limb) is infused into the circulation during 20 minutes for a total perfusion time of 60 minutes. According to local routine tasonermin (Beromun®) will be added to the perfusate 30 minutes before the melphalan as a bolus dose of 1-4 mg.
15895411|NCT03685864|Other|Suture Embedding Acupuncture|Suture Embedding Acupuncture at 8 acupoints (both sides of BL23, BL24, BL25, BL37). Receiving intervention 1 time in 2 weeks, and total receive 3 times.
15895412|NCT03685864|Other|Sham Acupuncture|Sham Acupuncture at 8 acupoints (both sides of BL23, BL24, BL25, BL37). Receiving intervention 1 time in 2 weeks, and total receive 3 times.
15895413|NCT03685851|Procedure|DSAEK type corneal transplant|All surgeries were performed by the same surgeon and according to the same protocol
15895414|NCT03685838|Other|Compression Stockings|Class II above knee compression stockings
15895415|NCT03685812|Diagnostic Test|Autocad software|The participants will be prepared for image-capture data collection by putting four squared markers on leg and thigh.Each subject will extend his/her leg and make two angles from the resting position (90º) to the full extension, photos will be taken. The tested leg passively moved by the researcher through 20° to 60° of knee extension, the participant will be instructed to actively move that leg to the target angle and hold it in this position another photograph will be taken. The angles will be measured using the AutoCAD software. Knee JPS measurements will also be collected using an IKD by same steps
15895416|NCT03685799|Diagnostic Test|Pathological revision|Pathological revision
15895790|NCT03682770|Drug|AR101|AR101 will be provided in dose-escalating capsules and then sachets during maintenance phase
15914662|NCT03537742|Biological|placebo|placebo to match alirocumab
15895417|NCT03685786|Biological|CART19 cell and auto-HSCT|Phase 1 Clinical Study of CD19-directed Chimeric Antigen Receptor-modified T (CART19) Cells treatment for Adult Patient with Minimal Residual Disease(MRD) of B Cell Malignancies and then Autologous Hematopoietic Stem Cell Transplantation(Auto-HSCT). Subjects will receive 0.5-4 x 10^8 transduced CAR T cells as a split dose over three days as follows:Day 0, 10% fraction: 0.5-4x10^7 CART19 cells, Day 1, 30% fraction: 1.5x10^7-1.2x10^8 CART19 cells, Day 2, 60% fraction: 3x10^7-2.4x10^8 CART19 cells. Auto-HSCT will be made about 6 mouths after CART19 cell is infused back to the patient.
15895418|NCT03685773|Drug|Diazoxide|"MRI studies: Non-diabetic and T2D participants will receive diazoxide (up to 7 mg/kg) between baseline MRI scan and second MRI scan.
~Clamp studies: Non-diabetic participants will not require an overnight admission. They will receive diazoxide (up to 7 mg/kg) and undergo the pancreatic clamp study. Type 2 diabetic participants will be admitted the evening before the study day to normalize blood sugar levels. They will then receive diazoxide (up to 7 mg/kg) the next morning and undergo the pancreatic clamp study."
15895419|NCT03685773|Drug|Placebo (for diazoxide)|"MRI studies: Non-diabetic and T2D participants will receive placebo (for diazoxide) between baseline MRI scan and second MRI scan.
~Clamp studies: Non-diabetic participants will not require an overnight admission. They will receive a taste-matched placebo (for diazoxide) and undergo the pancreatic clamp study. Type 2 diabetic participants will be admitted the evening before the study day to normalize blood sugar levels. They will then receive a taste-matched placebo (for diazoxide) the next morning and undergo the pancreatic clamp study."
15895420|NCT03685773|Drug|Nicotinic acid|Type 2 diabetic participants in this arm will receive a nicotinic acid infusion to lower free fatty acid levels. They will then receive diazoxide (up to 7 mg/kg) the next morning and undergo the MRI or pancreatic clamp study.
15895421|NCT03685760|Other|Reiki therapy|Reiki, a complementary health approach where trained practitioners place their hands lightly on or just above a person, in discrete positions, with the goal of facilitating the person's own healing response. Reiki therapists will administer the Reiki intervention (i.e., a 30-minute treatment in which the subject is lightly touched for 3 minutes at each of 10 standardized Reiki hand positions).
15895422|NCT03685760|Other|Sham Reiki|Sham (pretend) Reiki therapists will administer the sham Reiki intervention (i.e., a 30-minute treatment in which the subject is lightly touched for 3 minutes at each of 10 standardized Reiki hand positions). Sham providers do not have Reiki training.
15895423|NCT03685747|Drug|Vancomycin|Vancomycin one-time 20 mg/kg intraperitoneal dose.
15895424|NCT03685708|Biological|HEPLISAV-B|HEPLISAV-B (Hepatitis B Vaccine [Recombinant ], adjuvanted) vaccine - A series of 2 doses (0.5 ml each) will be given on a 0- and 3- month schedule via intramuscular injection.
15895425|NCT03685695|Other|Laboratory Biomarker Analysis|Correlative studies
15895426|NCT03685695|Device|Monitoring Device|Wear Fitbit Charge 2
15895427|NCT03685695|Other|Physical Activity|Complete aimed walking steps
15895428|NCT03685695|Other|Quality-of-Life Assessment|Ancillary studies
15895429|NCT03685695|Other|Questionnaire Administration|Ancillary studies
15895430|NCT03685682|Biological|recombinant subunit Herpes zoster vaccine|Seronegative Solid Organ Transplant patients will receive two doses of the subunit Herpes zoster vaccine at 0 and 2-6 months
15895431|NCT03685656|Other|Slimming gel|On the morning, one application per day on each area under study (thighs and abdomen) during 8 weeks.
15895432|NCT03685656|Other|Slimming gel placebo|On the morning, one application per day on each area under study (thighs and abdomen) during 8 weeks.
15895433|NCT03685643|Behavioral|Intervention - Dating application topic|The intervention will consist of multimedia content to promote the safe usage of dating applications and raise awareness of the risks associated with dating application usage. The intervention will be delivered one-time in a classroom setting.
15895434|NCT03685643|Behavioral|Control - Health and exercise topic|The placebo control will consist of multimedia content regarding exercise and healthy living. It will be delivered once-time in a classroom setting.
15895435|NCT03685630|Drug|Brivaracetam|"Pharmaceutical form: Solution for injection
~Concentration: 10 mg/ml
~Route of administration: Intravenous injection"
15895436|NCT03685617|Device|Dual Chamber Pacemaker|1. Conducting venipuncture. Subclavian vein is our first choice. Then we set up two venous channels and implant two guiding wires into postcava. 2.Putting 2 sheathing canals into heart along with guiding wires. 3.Locating the sheathing canals, and putting electrodes into canals. 3.Adjusting the electrodes and revolving them anticlockwise to lead them to right atrium and right ventricle respectively under the X-ray. 4.Immobilizing electrodes. 5. Some ways to determine whether the electrode is fixed or not: the head of the electrodes could beat rhythmically with atrium or ventricle or by testing damage current. 6.Removing the canals and suturing.
15895437|NCT03685617|Device|His Bundle Pacemaker|1.Conducting venipuncture. Subclavian vein is our first choice. Then we set up two venous channels and implant two guiding wires into postcava. One of the guide wire is 120cm in length, 0.035 or 0.038 in diameter, which is required to lead the C315 sheathing canal. 2.Putting C315 sheathing canal into heart along with guiding wires. 3.Locating the C315 sheathing canal, and adjusting the head of C315 towards ideal pacing location. 3.Implanting the spiral electrodes and fixing them. Leading the spiral electrode to the side of his bundle along the C315 canal under the X-ray. The other electrode is leaded to right atrium like dual chamber pacemaker under the X-ray. 4.Revolving the 3830 electrode suitably to Immobilizing it in cardiac muscle. If the electrode can get his electric potential and produce his bundle pacing successfully, we revolve the 3830 electrode and immobilize it.
15895438|NCT03685604|Drug|CHX disinfection|CHX (Softasept® Chlorhexidine solution 2% coloured, from B. Braun Medical AG) is applied three times on the patient's skin with the use of swabs. The cumulative residence time is a minimum of 3 minutes. The application is performed according to standard procedures of the participating centers and according to manufacturer's recommendations
15895439|NCT03685604|Drug|PI Disinfection|PI (Braunoderm® from B.Braun or Betaseptic® from Mundipharma) is applied prior to surgery on the patient's skin with the use of swabs. The product is applied three times. The cumulative residence time is a minimum of 3 minutes. The application is performed according to standard procedures of the participating centers and according to manufacturer's recommendations
15895442|NCT03685578|Device|EmboTrap® Revascularization Device|EmboTrap® Revascularization Device
15895445|NCT03685552|Other|Prog: Purify-2|"Nutritional Supplements to be administered:
~Protein Shakes: one protein shake twice a day
~Probiotics (Bacillus Coagulans) once a day
~Biome NO+ ( blend of amino acids, specifically l-arginine and l-citrulline, combined with red beet root, grape polyphenol extract, vitamins and minerals) twice a day
~In.Form Purify ( blend of psyllium hull, inulin, L-glutamine, fruit, fruit extracts and zinc) twice a day"
15895446|NCT03685539|Procedure|Dual-Energy Computed Tomography|Undergo DECT
15895447|NCT03685526|Device|Cinenses Lung Volume Reduction Reverser System|Lung Volume Reduction Reverser System is show as figure 1-4, consists of lung volume reduction reverser (short as: reverser), conveyor, measuring guide wire and transporting sheath. Matrix of reverser is nickel titanium alloy, its surface is coated by polymer flexible film, at the end of the connection segment is specially designed connector, which is easy for the reverser's transport and recycling. The silica gel part at the far end of reverser makes it softer.
15895448|NCT03685513|Other|BioHPP PEEK-based single posterior crowns|BioHPP PEEK is 20% ceramic reinforced, semicrystalline, thermoplastic and radiolucent polymer for extreme durability especially for frameworks for fixed and removable dental prostheses. It has many advantages as low density, light weight, shock absorber, biocompatible and venerable with composite resin.
15895449|NCT03685513|Other|Metal ceramic single posterior crowns|Standard metal coping veneered with glass ceramics
15895450|NCT03685500|Drug|Symtuza® (TAF/FTC/DRV/c)|Treatment with TAF/FTC/DRV/c during 8 weeks since randomized
15895451|NCT03685500|Drug|ABC/3TC/DTG + Symtuza® (TAF/FTC/DRV/c)|Patients continuing on treatment with DTG/3TC/ABC after the randomization for 4 weeks, and then switch to TAF/FTC/DRV/c for 8 weeks
15895452|NCT03685487|Procedure|decolonization|current practice : V1 : consultation to the service : nasal sample for all 5 days before surgery : order sent with decolonization procedure : nasal mupirocin, shower and mouthwash V2 : admission to the service : nasal sample for all and urine sample for decolonized patients V3 : nasal sample for all
15895453|NCT03685487|Other|compliance questionnaire|We asked if the patient has done the whole decolonization procedure
15895454|NCT03685474|Behavioral|Facing Your Fears - School Based|Participants receiving FYF-SB will receive cognitive-behavioral treatment (CBT), which is an evidence-based practice (EBP) for treating anxiety in typical youth, within their school setting.
15895455|NCT03685474|Behavioral|Usual Care|Participants receiving usual care will experience no different therapies, strategies, or recommendations other than what would typically be administered within the school setting in the absence of the proposed study.
15895456|NCT03685461|Other|Electrocochleography|Electrocochleography is a noninvasive method of monitoring for acoustic evoked electrophysiologic responses from the cochlea. A speaker in the external auditory canal presents a tone burst stimulus and a nearby electrode, in this case from the apical electrode of the cochlear implant, records changes in the electrical activity within the cochlea. Different functional elements within the cochlea have signature electrophysiologic responses that can be isolated and studied individually. Through the use of intracochlear electrocochleography during cochlear implant electrode insertion valuable insight can be gained about structural or physiological changes that may be occurring.
15895457|NCT03685448|Drug|Cabozantinib|The 20 mg cabozantinib drug product is a film-coated, white, round, immediate-release tablet. Cabozantinib should not be stored above 25°C (77°F).
15895458|NCT03685435|Other|Bedside ultrasound|Checking for gastric content using bedside ultrasound
15895459|NCT03685422|Other|Virtual Reality|Before surgery, consented patients are given a Virtual Reality headset with pre-installed relaxation apps to choose a preferred scenario. Patient will be asked on their satisfaction on the VR experience after the intervention. Hospital Anxiety and Depression Scale (HADS), Spielberger State-Trait Anxiety Inventory (STAI) and EQ-5D-3L questionnaires will be conducted during this period.
15895460|NCT03685409|Drug|Metformin Hydrochloride 500 MG|Metformin hydrochloride tablets 500 mg given orally once daily.
15895461|NCT03685409|Drug|Placebo Oral Tablet|Starch Placebo oral tablets will be given once daily to the control group
15895462|NCT03685396|Biological|Platelet rich fibrin ( PRF)|"Venous blood was collected with a butterfly needle in two 10 mL tubes without anticoagulants or other chemicals. The tubes were immediately centrifuged at 3000 rpm for 10 minutes.
~At the end of centrifugation a fibrin clot (PRF) was obtained in the middle of the tube, just between the red corpuscles at the bottom and acellular plasma at the top. The PRF clot was taken from the tube and the red cells portion at the base of the clot was eliminated with sterile scissors Then the PRF was enveloped in sterile gauzes and positioned between two glass plates: the compression drove out the serum from the clot obtaining PRF membranes that were ready to be used in the surgical site."
15895463|NCT03685396|Drug|hemostatic agents with oxidized and regenerated cellulosa|In the Control Group hemostatic agents with oxidized and regenerated cellulosa were sutured to the palatal wound with mattress suture ( silk 5/0).
15895464|NCT03685383|Device|Cytosorb removal column in eCPR|In addition to standard treatment in eCPR in the study group a CytoSorb removal column is added to the va-ECMO system for the prevention of post-cardiac arrest syndrome.
15895465|NCT03685383|Device|standard eCPR (va-ECMO)|Standard treatment in eCPR with a established va-ECMO system.
15895466|NCT03685370|Procedure|LOS|placement of epidural catheters with LOS technique
15895467|NCT03685370|Procedure|X-ray placement|placement of epidural catheters with x-ray guide
15895469|NCT03685331|Drug|Palbociclib|Combination of palbociclib, olaparib, and fulvestrant.
15895470|NCT03685331|Drug|Olaparib|Combination of palbociclib, olaparib, and fulvestrant.
15895471|NCT03685331|Drug|Fulvestrant|Combination of palbociclib, olaparib, and fulvestrant.
15895472|NCT03685318|Device|Use of conventional mouthguard|Use of a conventional custom-made mouthguard while playing water polo
15895473|NCT03685318|Device|Use of shortened mouthguard|Use of a shortened custom-made mouthguard while playing water polo
15895474|NCT03685305|Behavioral|Hypocaloric diet with hunger reduction strategy|Participants will be counseled to consume a hypocaloric diet during the 4-week weight loss phase. Counseling will include specific instructions on a dietary manipulation which may reduce hunger, in order to facilitate dietary adherence.This will include tracking of the strategy. They will also be provided a pedometer and instructed to attain 10,000 steps per day.
15895791|NCT03682744|Biological|anti-CEA CAR-T cells|Intraperitoneal delivery of anti-CEA CAR-T cells
15895475|NCT03685305|Behavioral|Hypocaloric diet without hunger reduction strategy|Participants will be counseled to consume a hypocaloric diet during the 4-week weight loss phase. They will also be provided a pedometer and instructed to attain 10,000 steps per day.
15895476|NCT03685292|Behavioral|Behavioral Advisory System|Support and training to help increase throughput while promoting upstanding stature and reproducibility in behavioral testing using cutting edge methodologies.
15895477|NCT03685292|Drug|Behavioral Treatment|This study addressed the efficacy of cognitive-behavioral therapy (CBT) treatment.
15895478|NCT03685292|Device|Behavioral Division|This study is relative to minimal contact control (MCC).
15895479|NCT03685279|Behavioral|Nurtured Heart Approach|Based on three stands designed to reduce negative reactivity from parents/guardians, increase positive interactions, and set firm, clear limits.
15895480|NCT03685266|Other|Observation|There are no specific interventions in this study; it is observational only. One could argue that the act of observing the participants may change their behavior (the Hawthorne effect).
15895481|NCT03685253|Drug|Niagen|Niagen® (3-(Aminocarbonyl)-1-β-D-ribofuranosyl-pyridinium chloride - NR) will be the experimental treatment, at a dose of 1000 mg/day taken as two 250 mg capsules twice daily for 6 months.
15895482|NCT03685253|Drug|Placebo|Placebo capsules matched to the experimental drug and taken orally as 2 capsules twice daily for 6 months.
15895483|NCT03685240|Behavioral|SafelyYou Fall Prevention System|Technology + Quality Assurance Services Provided by SafelyYou
15895484|NCT03685227|Other|Yoga Nidra|This is a mind/body technique. Specifically, it is a guided meditation, performed while lying down.
15895485|NCT03685214|Drug|0.9% saline|we use 0.9% saline in ICU patients with sepsis for resuscitation fluid.
15895486|NCT03685214|Drug|lactated Ringer's solution|we use balanced balanced crystalloids in ICU patients with sepsis for resuscitation fluid.
15895487|NCT03685201|Dietary Supplement|Orange Juice1|100% Orange Juice
15895488|NCT03685201|Dietary Supplement|Orange Juice2|100% Orange Juice with enzyme-treated orange pomace fiber
15895489|NCT03685201|Dietary Supplement|Raw Orange|Raw Orange
15895490|NCT03685188|Drug|Oxycodone Hydrochloride|Subjects will receive patient' controlled intravenous analgesia in analgesic pump with 0.4 mg/ml of oxycodone for postoperative analgesia.
15895491|NCT03685188|Drug|Sufentanil Citrate|Subjects will receive patient' controlled intravenous analgesia in analgesic pump with 2 μg/ml of sufentanil for postoperative analgesia.
15895494|NCT03685149|Drug|Flecainide Pill|Flecainide pill or placebo 100 mg administered twice a day for 4 weeks each
15895495|NCT03685149|Drug|Placebo|Flecainide pill or placebo 100 mg administered twice a day for 4 weeks each
15895496|NCT03685123|Behavioral|Physical activity recommendations|Participants in the PA-REC group will exercise at 550 MET min. per week in a supervised format
15895497|NCT03685123|Behavioral|Weight maintenance recommendations|Participants in the WM-REC group will exercise at 970 MET min. per week in a supervised format
15895498|NCT03685123|Behavioral|OPTIFAST weight loss|Participants will participant in an OPTIFAST medical weight loss program and exercise training
15895499|NCT03685110|Device|CoreHip Total Hip Arthroplasty|Replacement of the Hip Joint
15895500|NCT03685097|Diagnostic Test|Quantra System with the QPlus Cartridge|Point-of-care viscoelastic testing
15895501|NCT03685084|Drug|AAI101 i.v.|600 mg, 1 g, 2 g, 4 g, 1 g (every 6h), 2 g (every 6h)
15895502|NCT03685084|Drug|Saline 0.9% infusion|Vehicle infusion
15895503|NCT03685084|Drug|Piperacillin i.v.|piperacillin 3 g i.v.
15895504|NCT03685084|Drug|Cefepime i.v.|cefepime 1 g i.v.
15895505|NCT03685071|Other|role of CBC as prognostic tool in sepsis.|"Our study will be conducted on children who admitted to PICU in Assuit University Hospital .CBC parameters as TLC , platelet count , and Hb will be evaluated at time of admission , another CBC will be done at 5th day and another one at day of discharge or last one before death.
~patients will be classified into three groups according to the outcome(discharge, mortality and has morbidity sequel.)
~correlation between the outcome and CBC will be done."
15895506|NCT03685058|Device|Light curable resin modified glass ionomer varnish|Treatment of non-cavitated proximal carious lesions with light curable resin modified glass ionomer varnish at initial and six-months follow-up visits, in addition, the patient will receive standard-of-care preventive measures, at initial, six-months follow-up, and 12-months follow-up visits.
15895507|NCT03685058|Other|standard-of-care preventive measures|Patient will receive standard-of-care preventive measures which include application of 5% sodium fluoride topical varnish, oral hygiene instructions, and dietary counseling at initial, six-months follow-up, and 12-months follow-up visits
15895508|NCT03685045|Procedure|Campaign days|Participants who consent will complete study procedures (Hep C test, fibroscan, questionnaire, clinical assessment) and followed up through medical record review.
15895509|NCT03685032|Drug|Dexamethasone|The 4 mg of dexamethasone in 1 ml intravenous was administrated after patient received general anesthesia
15895510|NCT03685032|Drug|Ondansetron|The 4 mg of ondansetron in 2 ml intravenous was administrated at the end of the operation.
15895511|NCT03685032|Drug|0.9% Sodium Chloride Injection|The 0.9% sodium chloride in 1 ml intravenous was administrated after patient received general anesthesia. At the end of operation, the 0.9% sodium chloride in 2 ml intravenous was administrated.
15895512|NCT03685019|Radiation|Valgus Stress|Valgus stress radiograph
15895513|NCT03685019|Radiation|Varus stress|Varus stress radiograph
15895514|NCT03685019|Radiation|0 degree flexion radiograph|0 degree flexion radiograph
15895515|NCT03685019|Radiation|20 degree flexion radiograph|20 degree flexion radiograph
15895516|NCT03685019|Radiation|45 degree flexion radiograph|45 degree flexion radiograph
15895758|NCT03683017|Device|OrthoPulse 2.0|Patients are given OrthoPulse 2.0, an extended OrthoPulse device with no zone control (ability for doctor to control treatment regions). Patients complete 10 minute treatments (5 minutes each arch) every day.
15895517|NCT03684993|Drug|Arabic, Gum|natural gum of acacia tree: Antimicrobial, anti-inflammatory medicinal plant used as a traditional oral hygiene substance (anticariogenic). It is used in treating sore throats, colds, bronchitis, toothache, gingival bleeding and mouth ulcers.
15895518|NCT03684993|Drug|Licorice Root|natural licorice, herbal plant to relieve coughs, sore throats, and gastric inflammation. flavouring and sweetening agent. it's anti-caries, soothing anti-inflammatory and anticancer properties benefit against oral diseases and dental caries
15895519|NCT03684993|Drug|Chlorhexidine|chemical agent used as a mouthwash against cariogenic bacteria. considered the gold standard
15895520|NCT03684980|Drug|Voraxaze|Dose of Voraxaze will be 2000 units during cycles 1-4, and 1000 units during cycles 5-8.
15895521|NCT03684980|Drug|Methotrexate|(Cohort A) will receive MTX 3 g/m2 or (Cohort B) will receive MTX 8 g/m^2
15895522|NCT03684980|Drug|Rituximab|Patients will be treated with rituximab 500 mg/m^2.
15895523|NCT03684980|Drug|leucovorin|Patients will also receive standard of care leucovorin rescue starting at least 24 hours after MTX and 2 hours after Voraxaze. Cycles will be 14 days long.
15895524|NCT03684980|Drug|Glucarpidase|Glucarpidase 2000 units
15895525|NCT03684967|Drug|Fruquintinib|Fruquintinib treatment: 4mg in the Cycle 1,administration for 3 weeks followed by 1 week break, and administration every day for the first 21 days.5mg ,administration for 3 weeks followed by 1 week break, and administration every day for the first 21 days
15895526|NCT03684954|Other|Prf|Take 10 cc blood from patient and gain prf
15895527|NCT03684941|Device|Treatment Period One|LoFric Origo urinary catheter, 40-cm length, CH12/CH14 diameter, with Nelaton tip
15895528|NCT03684941|Device|Treatment Period Two|CE-marked LoFric Origo urinary catheter, 40-cm length, CH12/CH14 diameter, with Nelaton tip
15895529|NCT03684928|Device|Comfilcon A (test)|Daily wear contact lenses
15895530|NCT03684928|Device|Senofilcon C (control)|Daily wear contact lenses
15895531|NCT03684915|Device|Rotary files|using rotary files in cleaning root canals of infected primary molars
15895532|NCT03684902|Procedure|emergency midline exploratory laparotomy|Once an adequate level of anesthesia has been reached, the initial incision into the skin may be made. A scalpel is first used to cut into the superficial layers of the skin.with the diathermy The incision is then continued through the subcutaneous fat, the abdominal muscles, and finally, the peritoneum. (Morris J ;2017) For all the patients, closure of midline laparotomy wound was en-mass closure done with non-absorbable No. 1 (Polypropylene) or slowly absorbable (PDS) (double loop). sutures in continuous single layer fashion with 1 cm interval. (Morris J ;2017) The operative details were recorded with special consideration to the operative diagnosis, presence and types of adhesions, duration of surgery, the need for diversion and stoma formation, the use of intraperitoneal drain and the suture material to close the rectus sheath.
15895533|NCT03684889|Biological|SCRI-huCAR19v1|1:1 mixture of CD4:CD8 autologous T cells lentivirally transduced to express a second generation 4-1BB-ζ human CD19-specific CAR and Her2tG
15895534|NCT03684889|Biological|SCRI-huCAR19v2|Mixture of CD4:CD8 autologous T cells lentivirally transduced to express a second generation 4-1BB-ζ human CD19-specific CAR and Her2tG
15895535|NCT03684876|Procedure|diuretic use|use of diuretic
15895536|NCT03684863|Drug|Capecitabine|observation
15895537|NCT03684850|Other|Home-based exercise|Home-based exercises three times per week.
15895538|NCT03684850|Device|Knee brace|Progressive use of knee brace each day during activities of daily living.
15895539|NCT03684850|Device|Biomechanical footwear device|Progressive use of footwear each day during activities of daily living.
15895540|NCT03684837|Dietary Supplement|Vitamine D supplementation|a vitamine D dose for week
15895541|NCT03684837|Other|chronic exercise in whole body vibration (WBV)|exercise in WBV during 03 months, e times per week
15895542|NCT03684824|Drug|Long luteal phase GnRH agonist protocol|Pituitary suppression will be done using daily subcutaneous injection of triptorelin acetate ( Decapeptyl 0.1mg, Ferring, Germany). Starting from day 21 of the previous cycle
15895543|NCT03684824|Drug|Gonadotropins|Controlled ovarian hyperstimulation will be done using daily intramuscular injection of highly purified Human Menopausal Gonadotrophins (Merional 75 IU/ml, IBSA, Switzerland), starting from day 2-3 of the stimulated cycle, total dose will be adjusted according to patient response
15895544|NCT03684811|Drug|FT-2102|FT-2102 will be supplied as 150 mg capsule and will be administered per the protocol defined frequency and dose level.
15895545|NCT03684811|Drug|Azacitidine|Azacitidine will be administered per site's standard of care
15895546|NCT03684811|Biological|Nivolumab|Nivolumab will be administered per site's standard of care
15895547|NCT03684811|Drug|Gemcitabine and Cisplatin|Gemcitabine and Cisplatin will be administered per site's standard of care
15895548|NCT03684798|Other|MCII|In this study, the research staff will work through the MCII approach with the participant as an interactive, face-to-face training. The desired future consists of imaging an abstinent life and comparing it with personally relevant obstacles. Afterwards, the most relevant obstacle will be chosen and an if-then-plan will be formed, that refers to this obstacle.
15895549|NCT03684798|Other|Treatment as usual|The patients in the control group will receive a 2 x 2 contingency table about the disadvantages and advantages of being abstinent and of drinking. In addition, abstinence intentions of patients in the control group will also be supported and risk situations and relapse events since the last trainings will be reappraised, but without the use of MCII.
15895554|NCT03684772|Drug|ICVT Topical Gel|Digoxin and Furosemide (0.125%)
15895555|NCT03684772|Drug|Furosemide Topical Gel|Furosemide (0.125%)
15895556|NCT03684772|Drug|Digoxin Topical Gel|Digoxin (0.125%)
15895557|NCT03684772|Drug|Vehicle Topical Gel|Vehicle Gel
15895558|NCT03684746|Other|No Intervention|It is an observational Study with staff
15895559|NCT03684733|Diagnostic Test|MRI|Clinical MRI breast screening examination
15895787|NCT03682783|Diagnostic Test|Fundus Image|Fundus image of optic nerve
15895795|NCT03682705|Drug|Upadacitinib|Upadacitinib tablet will be administered orally.
15895560|NCT03684720|Other|Discover followed by direct instruction [DD]|The intervention group will be taught suturing using the principles of guided-discovery-learning. In its simplest form, this means allowing the participants to practice placing a simple interrupted suture using the materials needed, as well as a picture of a finished suture. They must then draw from their own learning experiences, as well as discover for themselves how to do it. After a discovery period, an instructor will then teach them, how to place a simple interrupted suture, and will them guide them, as they begin to practice again.
15895561|NCT03684707|Drug|Metformin Hcl 500Mg 24Hr Sa Tab|Glucophage 500 mg once daily
15895562|NCT03684707|Other|starch tablet|starch tablets
15895563|NCT03684694|Drug|Loncastuximab Tesirine|Intravenous (IV) infusion.
15895564|NCT03684694|Drug|Ibrutinib|Oral capsule.
15895565|NCT03684681|Behavioral|Peer Navigator Intervention|A peer navigator delivers an intervention to current drug users and uses their own training and real- life experiences to help people meet their goals.
15895566|NCT03684681|Behavioral|Social Work Intervention|A hospital social workers uses their own previous training to help people meet their goals.
15895567|NCT03684668|Behavioral|Psychoeducational intervention|The intervention will be carried out every 24 hours with four participants in four computers and 3D lenses available in the computer labs of the University.
15895568|NCT03684655|Drug|[18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D-arabinofuranosylguanine)|[18F]F-AraG is a radiolabeled high affinity substrate for deoxyguanosine kinase (dGK) and a low affinity substrate for deoxycytidine kinase (dCK), which are over-expressed in activated T cells.
15895569|NCT03684642|Drug|Efpeglenatide SAR439977|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous"
15895570|NCT03684642|Drug|Dulaglutide|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous"
15895571|NCT03684642|Drug|Metformin|"Pharmaceutical form: tablet
~Route of administration: oral"
15895572|NCT03684629|Behavioral|the response of KPI and corresponding suggestion|Standardized templates of medical record, evidence-based clinical pathway, and written care protocols are applied in all hospitals.The KPI of the AIS patients who were admitted to a single hospital continuously at the time of hospitalization were studied. Feedback system of performance measures: the hospital included in the study upload the medical records of all AIS patients by medical records scanning system since that month into the group. Quality control platform of Cerebral apoplexy in Zhejiang province extracts and analyze the data through the computer and calculates the corresponding monthly KPI. The hospitals will receive their own monthly KPI and the monthly highest KPI of all hospitals included in the study. Expert online consultation: based on the compare of the monthly KPI of all hospitals, Quality control platform will give corresponding suggestions to all hospitals for the improve of next month.
15895573|NCT03684616|Drug|Statin|continuous statin treatment for 3 months prior to cardiac arrest
15895574|NCT03684603|Behavioral|melody during motor training and slow wave sleep|sequence of tones which are presented to the patient using earphones
15895575|NCT03684603|Behavioral|melody only during motor training|sequence of tones which are presented to the patient using earphones
15895576|NCT03684590|Device|ANI-guided opioid administration|Intraoperative opioid will be administered guided by analgesia nociceptive index (ANI) values measured by ANI monitor (MetroDoloris Medical Systems, Lille, France)
15895577|NCT03684590|Other|Standard opioid administration|Intraoperative opioid will be administered according to standard practice during surgery.
15895578|NCT03684577|Behavioral|Hypnotherapy for Agoraphobia|see description of the experimental arm
15895579|NCT03684564|Drug|Rivaroxaban|Oral tablet 15 mg twice daily for 24 months
15895580|NCT03684564|Drug|Warfarin|Oral anticoagulant given as standard of care in the RISAPS trial to maintain a target INR of 3.5 (range 3.0-4.0) for 24 months
15895581|NCT03684551|Other|The CHW-led health system|During the study period, all CHWs, regardless of treatment arm, performed proactive case detection, the process of conducting at least two hours per day of door-to-door home visits to proactively identify - through health history inquiry and/or disease diagnostics - patients who need care. For all patients identified, CHWs provided doorstep counselling, evaluation, diagnostics, treatment, referral to appropriate health facilities, and follow-up. CHWs provided care in the community without user fees, and were able to refer patients to the reinforced government primary health centres for care without user fees as well. CHWs were residents of the communities they served, and they were required to be available at home or by phone for consultation at any time.
15895582|NCT03684551|Other|The CHW Supervision model|CHWs in both study arms received monthly individual supervisory sessions and weekly group supervisory sessions from their dedicated CHW supervisor. An individual monthly session of 360 Supervision included: (i) solicitation of patient perspectives of CHW care; (ii) direct observation of CHW doorstep care; and (iii) a one-on-one feedback discussion with or without the CHW Performance Dashboard depending on treatment arm.
15895583|NCT03684551|Other|The CHW Performance Dashboard|"The CHW Performance Dashboard was a graphic display of a CHW's performance along three indicators defined as follows: (i) Quantity of care: the number of homes visited during the month; (ii) Timeliness of care: the percentage of sick children under five treated within 24 hours of symptom onset during the month; (iii) Quality of care: the percentage of sick children under five treated without protocol error among 23 potential errors during the month. The Dashboard displayed an individual CHW's quantity, timeliness, and quality of care indicators from the previous month, using absolute numbers, percentages, and visual graphics, alongside those of the highest performing CHW. During the individual supervisory feedback session, this personalised and relative (to the highest performer) quantitative performance feedback helped orient the discussion of strengths and weaknesses, and allowed the CHW to see quantitatively and visually how his/her performance fared the previous month."
15895584|NCT03684538|Other|Probiotics|Patients will receive probiotics (Saccharomyces boulardii) one dose per day (250 mg)
15895585|NCT03684538|Other|Zinc|Patients will receive zinc (10 mg for patients less than 6 month and 20 mg for older patients) one dose per day
15895586|NCT03684538|Other|Probiotics & Zinc|Patients will receive a combination of probiotics (Saccharomyces boulardii 250 mg) with zinc (10 mg for patients less than 6 month and 20 mg for older patients) one dose per day
15895587|NCT03684538|Other|Standard care|initiation of hydration and early refeeding, in addition to the use of antimicrobials in case a pathogen was identified
15895792|NCT03682718|Device|Transcervical Foley catheter|combined methods of induction of labor Floey Catheter with misoprstol
15895588|NCT03684525|Procedure|Extraction of primary canines|"At Baseline (T0): Clinical examinatiion + CBCT scan and then both primary canines will be extracted At 6 month follow-up (T1): Clinical examination only At 12 month follow-up: Clinical examination +/- CBCT scan
~Treatment Plan :
~If displaced canine is not erupted and no improvement in position radiographically is noticed, patient will be referred to orthodontic/oral surgery department
~If Canine is emerged to oral cavity: No further CBCT scan will be taken
~If Position of canine is improved radiographically: Follow up untill canine emerges, total observation time is 18 months"
15895589|NCT03684512|Behavioral|Group Exercise Sessions|Remote exercise sessions delivered over group video conference
15895590|NCT03684512|Behavioral|Individual Support Sessions|Individual education/support/feedback sessions delivered over video chat
15895591|NCT03684512|Behavioral|Facebook Group|Facebook group for parents to provide additional support and education
15895592|NCT03684499|Other|fluid supplementation|The subjects will be divided into two equal groups Study group and control group by randomization. The study group will be given IV fluid supplementation with 0.5% normal saline in dextrose 5%for period of 24hours . The volume of supplementation included a presumed deficit of 50 ml/kg (equivalent to mild dehydration), half of daily maintenance fluid for 24 hours in accordance to standard norms and extra 20 ml/kg per day as a phototherapy allowance. In addition, they will continue breastfeeding. All the infants will get phototherapy by standard method. Phototherapy will be discontinued when the bilirubin level will be <15 mg/dl.
15895593|NCT03684499|Other|breast feeding|The subjects will be divided into two equal groups Study group and control group by randomization . The control group will be continued on breast feeding , before the randomization procedure. All the infants will get phototherapy by standard method. Phototherapy will be discontinued when the bilirubin level will be <15 mg/dl.(Bandyopadhyay et al, 2017)
15895594|NCT03684486|Behavioral|rehabilitation by effort|
15895595|NCT03684473|Behavioral|Yoga Intervention|"Online video instruction of yoga postures combined with breath awareness and meditation form the foundation of the intervention. The trauma-informed component of the program uses specific language, movement cues, teacher qualities, and physical assists. The yoga intervention will emphasize full choice and control of the participant through invitational language such as, when you are ready, if you like before each body posture cue. Based on trauma-informed yoga best practices, a predictable foundation of yoga postures (with variations) will be followed in a consistent order each session to allow participants to anchor to the series."
15895596|NCT03684460|Device|Daytime Bright Light|Daytime Bright Light (DBL) will be delivered by a free-standing apparatus set to deliver 10,000 lux. The device will be placed at the bedside within 36 inches of the patient's head and is expected to provide at least 1,250 lux at the angle of gaze. To remain in the study, the patient must be in the Intensive Care Unit (ICU) through 13:00 on day 2 (e.g., the first day of potential intervention). After day 2, DBL and other study activities will continue if the patient is transferred out of the ICU to the general medical floor.
15895597|NCT03684460|Device|Usual Light|"Usual care lighting in ICU.
~To remain in the study usual care patients must also remain in the MICU through 13:00 on day 2."
15895598|NCT03684447|Drug|Propofol|Series of 6 treatments with propofol.
15895599|NCT03684447|Drug|Propofol|Series of 6 treatments with propofol. May be able to cross over and receive 6 additional treatments with the high dose of propofol.
15895600|NCT03684434|Behavioral|Online MI plus Online CBT|An online motivational interviewing (MI) lesson will first be delivered to clients. The MI lesson is expected to take one hour to complete. No therapist support will be provided during this component of treatment. An 8-week Internet-delivered cognitive behavioural therapy (ICBT) will be then delivered to clients following completion of online MI. Clients will receive weekly support in the form of emails and phone calls from registered social workers, psychologists or supervised graduate students, who have experience delivering ICBT. Therapist will spend approximately 15 minutes per week/per client.
15895601|NCT03684434|Behavioral|Online CBT|An 8-week Internet-delivered cognitive behavioural therapy (ICBT) will be delivered to clients. Clients will receive weekly support in the form of emails and phone calls from registered social workers, psychologists or supervised graduate students, who have experience delivering ICBT. Therapist will spend approximately 15 minutes per week/per client.
15895602|NCT03684421|Diagnostic Test|Pregnancy Rate|The clinical pregnancy and live birth rate according to the protocol of COS
15895603|NCT03684408|Device|RFID Localization|The RFID and wire localization devices used in this study are FDA approved for the image guided localization of breast tumors prior to surgical excision. The two techniques for localization will be compared in this trial.
15895604|NCT03684408|Device|Wire Localization|The RFID and wire localization devices used in this study are FDA approved for the image guided localization of breast tumors prior to surgical excision. The two techniques for localization will be compared in this trial.
15895605|NCT03684408|Device|RFID and Wire Localization|Both RFID and the standard of care wire localization will be performed for physician training.
15895606|NCT03684395|Drug|DOACs: Rivaroxaban, Dabigatran, Apixaban|Routinely collected clinical data (secondary data from patients with non-valvular atrial fibrillation in Sweden); no primary data collection
15895607|NCT03684395|Drug|Standard of care (Warfarin)|Routinely collected clinical data (secondary data from patients with non-valvular atrial fibrillation in Sweden); no primary data collection
15895608|NCT03684382|Other|NeW-I group|A 5-week intervention offered to parents of children with chronic life-threatening illness using an internet-based narrative approach with life review elements. After completion of the first four weeks of the intervention, participants will receive a 'legacy' document which is a compiled and edited document of their narrative expression during the first four weeks. This legacy document is structured in a manner that enables participants to find a sense of spiritual well-being and hope in their experience of caring for their child through examination of past experiences and achievements as well as future aspirations.
15895609|NCT03684369|Device|Transcutaneous electrical nerve stimulation|Commercially available device will be used to apply weak electrical currents to arm and leg muscles in each of 18 treatment sessions.
15895610|NCT03684356|Procedure|socket shield technique|immediate implant placement with buccal part of the root is retained
15895611|NCT03684356|Procedure|xenograft|immediate implant placement with filling the buccal gap with xenograft
15895788|NCT03682770|Drug|Dupilumab|Dupilumab will be administered subcutaneously (SC) in a single-use, pre-filled glass syringe every two weeks (Q2W)
15895612|NCT03684343|Other|Filmed consultation with a dermatologist|"Patient will be seen by a dermatologist for a consultation which will be filmed. During the consult, a laterality test and a tactile sensitivity test will be performed.
~After the consult, videos will be analysed by scientists to identify the frequency of occurrence of each behavior and the percentage of time passed to express each behavior."
15895613|NCT03684330|Dietary Supplement|Vitamin D|a dose once a week
15895614|NCT03684330|Other|whole body vibration (WBV)|03 months of WBV training three times per week
15895615|NCT03684304|Device|Abdominal binder|The abdominal binder is an elastic abdominal compression / support device that will be placed on the patient after surgery has been completed.
15895616|NCT03684291|Procedure|Mode of Mechanical Ventilation|Adjustment of mechanical ventilation mode
15895617|NCT03684278|Drug|Infusion of 5 mg/kg Infliximab|Infliximab is a prescription drug with marketing authorisation for the treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. In the RAPID-I trial infliximab will be used outside the manufacturer's indication for the treatment of AP, and it is classed as an investigational medicinal product (IMP).
15895618|NCT03684278|Drug|Infusion of 10 mg/kg Infliximab|Infliximab is a prescription drug with marketing authorisation for the treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. In the RAPID-I trial infliximab will be used outside the manufacturer's indication for the treatment of AP, and it is classed as an investigational medicinal product (IMP).
15895619|NCT03684278|Other|0.9% Sodium Chloride (Placebo)|250 ml (500 ml if patient weighs over 100 kg) of 0.9% Sodium Chloride
15895620|NCT03684265|Drug|Meloxicam Capsule (Test)|single dose
15895621|NCT03684265|Drug|Meloxicam Tablet (Reference)|single dose
15895622|NCT03684252|Behavioral|CBT-based intervention|Cognitive Behavioral Therapy (CBT) that uses acceptance and mindfulness strategies, together with commitment and behavior change strategies.
15895623|NCT03684252|Other|Treatment as Usual|Participants' will receive treatment as usual.
15895624|NCT03684239|Behavioral|G-CBT|CBT is based on the model that there is a interaction between cognition, emotion and behavior. The way people think affects the way they feel and the behavior they do. And then the feelings in turn affect how they think,So it is valid for AN patient.
15895625|NCT03684239|Other|Conventional treatment|Conventional treatment including nutritional advice, encouragement, and routine treatment by a psychiatrist with work experience with eating disorders.
15895626|NCT03684213|Drug|Control (Norepinephrine)|This intervention is aimed at assessing the vascular responsiveness to norepinephrine, an alpha 1-agonist, in white and black men and women across a series of ascending dose concentrations.
15895627|NCT03684213|Drug|Norepinephrine + Ascorbic Acid|This intervention is meant to globally assess the impact of oxidative stress on vasoconstrictor responses by scavenging numerous oxidative molecules.
15895628|NCT03684213|Drug|Norepinephrine + L-NAME|This intervention is meant to assess the impact of endothelium-derived nitric oxide on vasoconstrictor responses by inhibiting production of this source of nitric oxide.
15895629|NCT03684213|Drug|Norepinephrine + L-NAME + Ascorbic Acid|This intervention is meant to assess the combined impact of scavenging oxidative stress and inhibiting endothelium-derived nitric oxide on vasoconstrictor responses.
15895630|NCT03684200|Other|Copenhagen adductor exercise|The active player is supported on one forearm on the floor and the upper arm is resting along their side. The supporting partner places their hands at the ankle and the knee of the upper leg. The active partner raises their body from the floor and adducts both legs in a three second movement until the body reaches a straight line. The body is then lowered to the ground in a three second movement, the foot of the lower leg touches the ground before performing another repetition.
15895631|NCT03684187|Behavioral|Mindfulness Based Intervention|"Mindfulness - Based Intervention (MBI) Course:
~The 8-week MBI program is comprised of an orientation session, 8 separate weekly sessions of 2.5 hours and also a 7.5 hour retreat session on a weekend day. The orientation session will include an introductory session, description of the course and will include completion of stress surveys. During the orientation session, there will be explanation to the patients of objectively the basis of mindfulness teaching. The role of the stress surveys that are conducted are to assess an individual's degree of stress prior to the initiation of any mindfulness practice teaching.
~Subjects will also be asked to wear a BodyGuard 2 (BG2) for parts of the study, on average of 7 days at baseline, end of the control phase, end of intervention phase, and end of 48 week follow up period. This will track subjects heart rate (HR), HR variability, VO2, energy expenditure and activity."
15895632|NCT03684174|Device|Intraocular pressure measurement|Pressure tip or air puff is applied on eye
15895633|NCT03684161|Diagnostic Test|Cardiopulmonary function|Body composition measurements; Pulmonary function tests; Cardiopulmonary exercise test; Force frequency releationship, ultrasound
15895634|NCT03684148|Other|Motor imagery practice|In detail, they were advised to imagine maximal voluntary isometric contractions (MViC). MViC imagery practice was planned in a progressive manner. Thus, it was performed in two sets of 25 repetitions with 2 minutes of inter-sets rest period, for two weeks, and 10 additional repetitions were added on week three and four, respectively. Each MViC repetition was sustained for 5 seconds, followed by 5 seconds of inter-repetition rest periods. Additionally, after every fifth contraction, participants had a 20 seconds of rest. Following 5 days of MI practice, the participants were advised to take a break from MI for two consecutive days. After hospital discharge, the participants in the MIp group were supplied with an audio description of the exercises to be performed.
15895635|NCT03684135|Other|Cosmetics|"Tendre Caresse au cold cream body cream from Cosmétosource Crème de douche face and body cleanser from Cosmétosource"
15895636|NCT03684122|Biological|Injection of Umbilical cord derived MSCs|Allogenic umbilical cord derived MSCs which are to be injected intrathecally and intravenously as a treatment option for consenting PD patients
15895637|NCT03684109|Device|3T MRI Scanner|3T MRI Scanner providing Mega-laser sequence for single-voxel Magnetic Resonance Spectroscopy (MRS) data for 2 hydroxyglutarate (2HG) quantitation.
15895638|NCT03684096|Dietary Supplement|non-estrogenic pollen extract PCC-100|non-estrogenic pollen extract PCC-100
15895639|NCT03684096|Other|placebo|placebo -non-estrogenic pollen extract PCC-100
15895640|NCT03684083|Procedure|bronchial biopsies|bronchial fibroscopy with bronchial biopsies
15915854|NCT03528863|Other|Questionnaire Administration|Ancillary studies
15895643|NCT03684057|Behavioral|App-based mindfulness training|Unwinding Anxiety is an app-based mindfulness training program which includes a progression through 30+ daily modules. Each module's training is delivered via short video tutorials and animations (~10 min/day). Each training builds on the previous one; modules are 'locked' so that they can only be viewed at a pace of 1/day (previous modules can be reviewed at any time). A built-in self-assessment is taken after every seven modules to ensure key concepts are learned before moving on with automated suggestions on which modules to repeat based on the self-assessment results. User-initiated guided practices range from short exercises (30 seconds) to manage anxiety the moment it arises to formal guided meditations (up to 15 minutes), and can be accessed at any time
15895644|NCT03684044|Drug|Baloxavir Marboxil|Baloxavir marboxil will be administered as a weight-based dose on Days 1 and 4. A third dose will be given on Day 7 for participants who have not improved according to protocol defined criteria on Day 5.
15895645|NCT03684044|Other|Placebo|Participants will receive matching placebo on Days 1, 4 and 7.
15895646|NCT03684031|Behavioral|Cognitive Control Training|A computer-based flanker task that aims to reinforce the recruitment of cognitive control in the presence of hostile/aggressive stimuli.
15895647|NCT03684031|Behavioral|Sham Cognitive Control Training Program|A placebo version of the computer-based cognitive control training. Designed to appear similar to the experimental task, but will not reinforce the recruitment of cognitive control in the presence of hostile/aggressive stimuli.
15895648|NCT03684018|Biological|IgPro10|Normal human immunoglobulin G administered intravenously
15895649|NCT03684005|Other|MyPatientPal smartphone app|All patients in this single-arm study will use a smartphone-based app, MyPatientPal, to enter symptoms and track medications related to their cancer treatment. No drugs will be administered for the purposes of this behavioral study.
15895650|NCT03683992|Device|Triathlon total knee system|Implantable
15895651|NCT03683979|Behavioral|Interpretation Bias Modification|A computer based interpretation bias modification program that aims to reinforce neutral interpretations of ambiguous social situations.
15895652|NCT03683979|Behavioral|Control Training Program|A sham training program that is similar in design and delivery to the experimental training condition.
15895653|NCT03683953|Other|mesenchymal stem cells therapy|mesenchymal stem cells treatement of BPD for safety and effect evaluation0.9% sodium chloride incontrol group
15895654|NCT03683953|Drug|0.9% sodium chloride|0.9% sodium chloride in control group
15895655|NCT03683940|Diagnostic Test|Screening|Subjects will undergo a low dose non contrast CT chest for lung cancer screening. The test will be performed by the UCH Radiology Department and read by board-certified chest radiologists using Lung-RADS criteria.
15895656|NCT03683927|Combination Product|Bacillus clausii|The probiotic (Bacillus clausii) will be administered 4 times a week to the infant
15895657|NCT03683927|Other|Sterile water|The placebo group will receive sterile water 4 times a week
15895658|NCT03683914|Drug|Dinoprostone 3Mg Vaginal Tablet|1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia & Upjohn, Puurs, Belgium) inserted by the patient 12 hours before the scheduled office diagnostic hysteroscopy.
15895659|NCT03683914|Drug|placebo vaginal tablet|1 vaginal tablet of placebo inserted by the patient 12 hours before the scheduled office diagnostic hysteroscopy.
15895660|NCT03683901|Device|TENS|Electrical Stimulation
15895661|NCT03683901|Device|t-NMES|Electrical Stimulation
15895662|NCT03683901|Other|No stimulation|No stimulation
15895663|NCT03683888|Behavioral|HealthSnap|HealthSnap provides personalized lifestyle reports and track progress over time using an electronic lifestyle record (ELR). HealthSnap Assessment is a simple, quick and not invasive tool that uses an algorithm that includes a questionnaire, physical measurements, dietary data and body fat indices
15895664|NCT03683888|Behavioral|dietary counseling|Dietary counseling by RD. Low Calorie and/or Low Carb dietary plans will be discussed and provided to the study participant
15895665|NCT03683862|Other|orthodontic appliance|Orthodontic device for retention in the upper arch, after the end of orthodontic treatment
15895666|NCT03683849|Other|Training|One hour of training, twice a week, for six months.
15895667|NCT03683836|Diagnostic Test|No intervention|No intervention
15895668|NCT03683823|Behavioral|Attention guidance|Explicitly guiding attention towards faces during public speaking exposures
15895669|NCT03683823|Behavioral|Control intervention|Public speaking exposures
15895670|NCT03683810|Dietary Supplement|Lactoferrin|Lactoferrin in tablets 4g/daily
15895671|NCT03683810|Drug|Recombinant human erythropoietin|Recombinant human erythropoietin (rHuEPO, epoetin alfa)
15895672|NCT03683797|Other|Post-discharge call|Patients will receive a call 1-3 days after they were discharged from the hospital to make sure their healthcare needs are being met.
15895673|NCT03683771|Diagnostic Test|Transvaginal US with Doppler study|Transvaginal Ultrasound with doppler study on endometrium will be made
15895674|NCT03683758|Other|FIFA11+|"The FIFA11+ has three parts and consist of 15 exercises.
~Part 1 consists of active stretching, running and controlled partner contact drills.
~Part 2 has three difficulty levels for 6 sets of exercises. The exercises consist of core and leg strength exercises, balance and plyometric drills. The exercises in this section are perhaps the most unique element to the FIFA11+ warm-up, as strength-specific exercises like the Nordic Hamstring Curl are not generally included in soccer warm-ups.
~Part 3 consists of higher intensity running drills, compared to those covered in Part 1.
~Unlike many soccer warm-ups, the FIFA11+ has been studied rigorously in terms of its injury reduction potential."
15895675|NCT03683758|Other|'Usual' Soccer Warm-up|"This warm-up is time-matched to the FIFA11+ (approximately 20 minutes) and is considered 'usual' for the team.
~This warm-up consists of stretching, running and agility drills, in addition to small sided games with a soccer ball, which is not a part of the FIFA11+.
~The 'usual' warm-up is decided by the coach with no standardization nor any formal research on its effectiveness in injury reduction or performance enhancement."
15895676|NCT03683732|Behavioral|Individual semi-structured interviews|Individual semi-structured interviews were conducted using purposeful sampling of 15- to 18-year-olds, until data saturation, and were transcribed and analysed
15895677|NCT03683719|Drug|Delgocitinib cream|Cream for topical application.
15895678|NCT03683719|Drug|Delgocitinib cream vehicle|The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
15917230|NCT03518112|Drug|Leucovorin Calcium|Given IV
15895679|NCT03683706|Behavioral|LTP in My Own Way Plus|LTP in My Own Way Plus is a 12-session integrated intervention-Learning through Play in My Own Way Plus Cognitive Behaviour Therapy (CBT). LTP in My Own Way is the extension of the parent education program called 'Learning Through Play' developed by Toronto Public Health (1993) revised by The Hincks-Dellcrest Centre (2000). LTP aims for the healthy growth of young children (birth to 6 years) using the stages of development incorporating Piaget's theory of cognitive development and Bowlby's theory of attachment. The objective of this program is to strengthen parent-child attachment by encouraging parental involvement and teaching parents how to use play activities to enhance their children's development. Second component of intervention is CBT adapted from Jeanne Miranda manual (Group CBT for Depression, group leaders guide book-2006) focusing on the three areas: thoughts and your mood, activities and your mood, people interaction and your mood.
15895680|NCT03683693|Diagnostic Test|Procalcitonin group|"The ICU physician gets on regular base (day 0, d4, d7, d11, d15, d19, d23, d27) a PCT value and the according non-binding recommendation:
~PCT < 0.5 microgram/L of 80% drop of the peak value : antibiotic stop recommended.
~PCT < 0.25 microgram/L: antibiotic stop strongly recommended. The recommendation is not-binding and can be overruled by the ICU physician. The intervention is only set up for stopping antibiotics, not for initiating. PCT measurements only happens in case of still ongoing antibiotic course. In case of a second course of antibiotics, after interruption of the initial course, new PCT measurement will take place at this point followed by the continuation of the initial schedule of PCT measurement.
~Intervention ends 28 days after inclusion."
15895681|NCT03683680|Other|MPT Test|molecular expression tests at the RNA level using approximately 7 or more genes with RTPCR, nanostring or similar platforms
15895682|NCT03683680|Other|CLDN15/VIM Test|molecular expression tests at the RNA level using approximately 7 or more genes with RTPCR, nanostring or similar platforms
15895683|NCT03683667|Drug|Azithromycin Oral Product|Azithromycin oral suspension (10 mg/kg; 3 days) administered by study personnel at 6 and 9 months of age
15895684|NCT03683667|Drug|Placebos|Contain inert excipients only
15895685|NCT03683667|Dietary Supplement|Protein Supplement|Blended food providing 125 kcal and 10 g protein as egg white powder prepared as porridge and fed daily to infants from 6-12 months of age
15895686|NCT03683667|Dietary Supplement|Isocaloric Supplement|Blended food providing 125 kcal and 1 g protein as rice powder prepared as porridge and fed daily to infants from 6-12 months of age
15895687|NCT03683667|Dietary Supplement|Egg|Egg provided daily to infants from 6-12 months of age
15895688|NCT03683667|Behavioral|Nutrition Education|Monthly messaging on infant and young child feeding
15895689|NCT03683654|Other|Identify Biomarkers of Dietary Intake in Healthy Subjects|Observational study. No intervention.
15895690|NCT03683641|Device|Extracorporeal Shock Wave Therapy|Use ESWT on chronic insertional Achilles tendinopathy
15895691|NCT03683641|Device|Sham Control group|Use sham ESWT on chronic insertional Achilles tendinopathy
15895692|NCT03683628|Procedure|PB-MNC therapy|The patients will receive subcutaneous injection of Granulocyte colony stimulating factor (G-CSF) for 3 day. The mononuclear cell will be collected by blood cell separator. The 120 cc of cell solution will be injected into calf or thigh of ischemic limb (1cc per site) with needle no. 25 gauge. Patients will receive ASA 81 mg once daily and walking exercise 3 times/ week
15895693|NCT03683628|Drug|No PB-MNC therapy|Patients will receive ASA 81 mg once daily and walking exercise 3 times/ week
15895694|NCT03683615|Procedure|repair of orbital floor fractures using resorbable plates|
15895695|NCT03683602|Other|PNF group|PNF is used in treatment of musculoskeletal pain of cervical and lumbar spine. Proprioceptive neuromuscular facilitation is a rehabilitation concept widely used by physiotherapists in many countries, in which stimulation of central nervous system is to achieve the highest possible functional level
15895696|NCT03683602|Other|manual therapy group|"Manual therapy is used for an assessment and treatment of joint and soft tissues.
~The basic therapeutic tool is mobilisation. In the study joint mobilisation according to Kaltenborn-Evjenth Manual Therapy was used. The joint were mobilised with low velocity passive movements in the whole or end range. Spinal manipulation wasn't used. Liter Exelby reports that manual therapy with joints mobilisation was quite effective in improvement of functional movements and decreasing of pain."
15895697|NCT03683576|Drug|GB001|film-coated oral tablet
15895698|NCT03683576|Drug|Placebo|film-coated oral tablet
15895699|NCT03683563|Other|4% sodium citrate|the catheter will be locked with 4% citrate solution after each dialysis session
15895700|NCT03683563|Other|30% sodium citrate|the catheter will be locked with 30% citrate solution after each dialysis session
15895701|NCT03683550|Procedure|SLNE with preoperative hybrid SPECT/CT|Single-photon emission computed tomography/computed tomography (SPECT/CT) provides complementary functional and anatomical information and has been shown to be superior to planar imaging in a number of indications. It can provide valuable information before sentinel lymph node biopsy and advocate its use in a range of tumors such as truncal and head and neck melanomas.
15895702|NCT03683550|Procedure|Standard SLNE|"The current gold standard for detection and targeted extirpation of the sentinel lymph node (SLN) is preoperative lymphoscintigraphy.
~Lymphoscintigraphy (sentinel lymph node mapping) is an imaging technique used to identify the lymph drainage basin, determine the number of sentinel nodes, differentiate sentinel nodes from subsequent nodes, locate the sentinel node in an unexpected location, and mark the sentinel node over the skin for biopsy."
15895703|NCT03683537|Diagnostic Test|Glial fibrillary acidic protein|3 samples of serum are drawn from patients. The 1st Sample of patient serum is drawn before induction into anesthesia. The 2nd is drawn 24 hours after the 1st one. The 3rd sample is drawn on 3 or 4 postoperative day. All samples collected and preserved in the same temperature as required for ELISA.
15895704|NCT03683524|Drug|Dolutegravir (DTG) plus Darunavir/cobicistat (DRV/cobi).|bitherapy based on DTG (50 mg QD) plus DRV/cobi (800/150 mg QD)
15895705|NCT03683524|Drug|Current ART|To continue with their current ART
15895706|NCT03683498|Biological|Regulatory T-cell enriched infusion|Enrichment of CD25hi regulatory T cells from CD8 and/or CD19 pre-depleted leukapheresis products.
15895707|NCT03683485|Procedure|long duration EPBD|An 8-mm dilatation balloon was used for EPBD. Balloons were gradually inflated to maximum pressure for 3 minute, and complete inflation was verified by fluoroscopy.
15895789|NCT03682770|Drug|Placebo matching dupilumab|Placebo matching dupilumab is prepared in the same formulation without the addition of protein
15895709|NCT03683472|Behavioral|Unwinding Anxiety Phone App|"The Unwinding Anxiety program focuses on teaching individuals 1) to understand how anxious worry is developed and perpetuated through reinforcement learning, 2) how to recognize these worry habit loops and 3) how to bring mindful awareness to moments of worry such that they can uncouple feelings of anxiety from reactive worry thinking and ride out habitual mind states that perpetuate and reinforce anxiety"
15895710|NCT03683459|Device|FemFlow Drug-Eluting Peripheral Balloon Catheter|Medical devices will be applied to the enrolled subjects. The arterial pathway was established, followed by lower limb arteriography, and the auxiliary equipment was selected according to the stenosis of the subject's target lesions, followed by pre-dilation. Patients with residual stenosis ≤70% after pre-dilation and suitable for simple balloon dilation catheter treatment can be enrolled. Select the appropriate size of the experimental drug balloon for expansion, then radiography was used to observe the expansion effect, if necessary, multiple expansion can be conducted, and finally withdraw the instrument and suture the puncture point.
15895711|NCT03683446|Procedure|Laparoscopic rectal surgery|Minimally invasive surgery and specialized technique for performing surgery using smaller incisions (or ports) to enter into the abdomen or anus for a tubular instrument(trochar), and a special camera (laparoscope), which is passed through the trochars to visualize the colon.
15895712|NCT03683446|Procedure|Open rectal surgery|Surgery performed through a single long incision (cut) in the abdomen (belly) to access the colon and/or the rectum.
15895713|NCT03683433|Drug|Azacitidine|Given SC or IV
15895714|NCT03683433|Drug|Enasidenib Mesylate|Given PO
15895715|NCT03683420|Behavioral|Music Therapy|The intervention consists of using an iPod to listen to music for up to 60 minutes while patients are receiving chemo infusion. There are no on components to the study.
15895716|NCT03683407|Other|Next-Genernation Sequence|Tumor Mutation burden will be evaluated using NGS after 2-cycle chemotherapy, 4-cycle chemotherapy, or at progressive disease
15895717|NCT03683394|Behavioral|SMARRT Intervention|Interventionists will follow a standard protocol for delivering the SMARRT intervention that allows for personalization of the specific risk reduction action plan; these plans will evolve over time according to participant progress, motivation and preferences or newly identified risk factors. Staff will use a tracking database to record information for each participant, including session dates, identified risk factors, motivational barriers and important values, and the outcome of discussions around developing goals. For each participant, the exact number and mode (phone or in-person) of contacts will differ, but we will aim to have at least 1 contact per month with each participant. Best practice will include in-person meetings twice a year during the 2-year intervention period.
15895718|NCT03683394|Behavioral|Health Education Intervention|Participants randomized to the Health Education (HE) group will receive mailed materials (typically 1-2 pages) every 3 months. This will include general information on Alzheimer's and dementia risk reduction using materials from sources such as the Alzheimer's Association and educational materials commonly provided as part of routine care at Kaiser Permanente Washington (KPWA).
15895719|NCT03683381|Behavioral|Sleep Health|Participants in the intervention group will be provided with an application containing weekly instructions to improve sleep
15895720|NCT03683381|Other|Patient education|Participants in the Patient education group will receive weekly information on insomnia symptoms
15895721|NCT03683368|Device|YpsoPump Orbit soft|Insulin infusion sets will be used for up to 7 days or until failure
15895722|NCT03683368|Device|YpsoPump Orbit micro|Insulin infusion sets will be used for up to 7 days or until failure
15895723|NCT03683355|Radiation|18F-FDG PET/CT|18F-FDG PET/CT and blood cultures will be performed at 3-month follow-up after TAVR Patients with positive 18F-FDG PET/CT (moderate or intense radiolabeled tracer uptake) will be scheduled for a second 18F-FDG PET/CT at 6-month follow-up.
15895724|NCT03683342|Procedure|Ankle Block|Ankle block will be performed prior to surgery under ultrasound guidance
15895725|NCT03683342|Procedure|Sciatic nerve block|Sciatic nerve block will be performed prior to surgery under ultrasound guidance
15895726|NCT03683329|Other|Antibiotic de-escalation|"All the therapeutic protocols made the object of a consensus between the different partners of the study.
~Antibiotic treatment will be delivered according to current practice, in agreement with the national and international recommendation."
15895727|NCT03683329|Other|Standard treatment|Antibiotic treatment will be delivered according to current practice, in agreement with the national and international recommendation.
15895728|NCT03683303|Behavioral|mobile applications (APP)|"the experimental group receiving education using Mobile Application (APP), collected data using Wound Care Knowledge Scale, Wound Care Skills Scale, State Trait Anxiety Inventory and Heart Rate Variability at three phases, including before the intervention (T1), after 3 times of intervention (T2), and before discharge from hospital (T3). The SPSS 22.0 for Windows was used for statistics analyses."
15895729|NCT03683303|Behavioral|oral education|"the control group receiving the oral education, collected data using Wound Care Knowledge Scale, Wound Care Skills Scale, State Trait Anxiety Inventory and Heart Rate Variability at three phases, including before the intervention (T1), after 3 times of intervention (T2), and before discharge from hospital (T3)."
15895730|NCT03683290|Other|Image acquisition and analysis|Oocyte image obtention and analysis prior to intracytoplasmic sperm injection
15895731|NCT03683277|Drug|Ixazomib/Pomalidomide/Dexamethasone|"Treatment with association of Ixazomib, Pomalidomide and Dexamethasone (IPD)
~Induction phase : 21-days cycles - maximum of 17 cycles Ixazomib (tablets) 3 mg D1, D4, D8 and D11 Pomalidomide (tablets) 4mg D1 to D14 Dexamethasone (tablets) 40 mg/d D1, D8 and D15 if patient aged <75 years Dexamethasone (tablets) 20 mg/d D1, D8 and D15 if patient aged ≥ 75 years
~Treatment with association of Ixazomib and Pomalidomide (IP) Maintenance phase : 28-days cycles until disease progression Ixazomib (tablets) 4mg D1, D8 and D15 Pomalidomide (tablets) 4mg D1 to D21"
15895732|NCT03683264|Other|Ultrasound diagnosis of avulsion of the levator ani muscle|In the multi-view ultrasound images, complete avulsion was defined as an abnormal insertion of LAM in the lower pubic branch identified in all three central slices, i.e. in the plane of minimal hiatal dimensions (PMD) and the 2.5 and 5.0mm slices cranial to this one. Levator hiatus measurements, transverse diameters, anteroposterior diameters and area were also determined in the same plane (PMD).
15895733|NCT03683251|Drug|PDS Implant with Ranibizumab 100 mg/mL|Will be administered as per the schedule described in individual arm
15895734|NCT03683238|Dietary Supplement|Mediterranean Diet|We aim to determine the effects of the traditional Mediterranean Diet on Hidradenitis suppurativa
15895736|NCT03683212|Procedure|Early intensive care bundle|"The care bundle comprises a list of items to follow and tick on a handover checklist within 4 hours of ED management:
~Treatment of the congestion: (international guidelines and recommendations)
~Treatment of precipitating factors
~NIV (non-invasive ventilation) if respiratory distress with hypercapnia and pH < 7.35 in absence of contra indication.
~Preventive LMWH (low molecular weight heparin) if no pre-existing anticoagulation therapy."
15895737|NCT03683199|Procedure|Rhinoplasty|"The cleft lip rhinoplasty will be performed under general anesthesia.
~1: 100,000 epinephrine will be infiltrated in the columellar incision and in the septum.
~Open approach rhinoplasty will be used. A step ladder incision placed at the patient's columella, and continued with infra-cartilaginous incision.
~The columellar skin flap along with the nasal tip skin will be dissected from the lower lateral cartilages.
~Harvesting of the septal cartilage, to be used as spreader graft and columellar graft. Correction of the septal deviation.
~Lengthening of the columella on the expense of the ala. Correction of the nasal tip by suturing techniques and by cartilage grafts."
15895738|NCT03683186|Drug|Ralinepag|Active
15895739|NCT03683173|Behavioral|Intervention|Participants in the intervention arm may receive community events, partake in walking groups, and receive short messaging service.
15895740|NCT03683160|Other|Cognitive Augmented Mobility Program|CAMP will combine education, one-on-one cognitive strategy training, and a cardiovascular and strength-training program conducted within a group setting. It will be run as a group of up to 6 participants, facilitated by a physiotherapist and a physiotherapy assistant or kinesiologist. It consists of 2 phases with a total of 19 sessions: Intervention Preparation (3 sessions), Active Intervention (16 sessions), and Follow-Up (1 session).
15895741|NCT03683147|Other|Laboratory Biomarker Analysis|Correlative studies
15895742|NCT03683147|Behavioral|Meditation-Based Stress Reduction Program|Participate in 6-week online program
15895743|NCT03683147|Other|Quality-of-Life Assessment|Ancillary studies
15895744|NCT03683147|Other|Questionnaire Administration|Ancillary studies
15895745|NCT03683134|Behavioral|Mediterranean diet|Participants will receive nutrition education and educational materials from a registered dietitian on patients on the patterns of a Mediterranean style diet. Seven education sessions will be delivered through an online platform. Participants will be asked to complete one education session per week for the first six weeks and the final session at week 9.
15895746|NCT03683134|Dietary Supplement|Olive oil and mixed nuts|Participants in the Mediterranean diet group will receive 3 liters of extra-virgin olive oil and 3 pounds of mixed nuts (1.5 pounds raw almonds and 1.5 pounds raw walnuts) at baseline and at 6 weeks. Participants will be educated by oral and written means, on consumption goals of the nuts and olive oil.
15895747|NCT03683134|Behavioral|American Heart Association|Participants will receive nutrition education and educational materials from a registered dietitian on patients on the dietary recommendations from the American Heart Association for heart health. Seven education sessions will be delivered through an online platform. Participants will be asked to complete one education session per week for the first six weeks and the final session at week 9.
15895748|NCT03683108|Drug|Resveratrol and Carbossimetyl Beta Glucan|Medical device based on Resveratrol and Carbossimetyl Beta Glucan. 3 drops, 4 times a day for 1 week.
15895749|NCT03683108|Other|Saline Solution|Medical device based on Saline Solution. 3 drops, 4 times a day for 1 week.
15895750|NCT03683095|Procedure|Lymphovenous bypass|"Lymphovenous bypass will be performed under general anesthetic. Indocyanine green lymphangiography will be performed by injecting indocyanine green into each finger / toe web of the lymphedematous limb and mapping the lymphatic system with the NOVADAQ SPY Fluorescence Imaging (Mississauga, Canada).
~Subdermal dissection of lymphatics and venules will be carried out under a surgical microscope. Lymphatic vessels will be anastomosed to adjacent recipient venules to create the bypass between the lymphatic and the venous systems. In total, 1-5 anastomoses will be performed. This will require 1-5 incisions, each with a length of 2-3 cm.
~Postoperatively, the limb will be wrapped loosely with compression bandages. No special postoperative monitoring is required.
~The surgery will be performed on an outpatient basis with no planned hospital stay."
15895751|NCT03683082|Drug|Oxygen supplementation|40% FiO2 via Venturi mask
15895752|NCT03683082|Drug|Sham O2 (medical air)|Medical air supplementation via Venturi mask
15895753|NCT03683069|Drug|Eplerenone vs Amlodipine|We posit that decreases in striatin activity/levels increases aldosterone secretion resulting in hypertension and salt sensitive blood pressure. Thus, our mechanistic clinical study will assess whether hypertensive striatin risk allele carriers will show significantly greater reductions in blood pressure with a specific aldosterone mediated treatment approach (mineralocorticoid receptor blockade) than with a non-specific approach (amlodipine). To test this hypothesis, we will perform a randomized, double-blind, active controlled study in hypertensive carriers of the striatin risk allele using a novel two-limb, proof-of-principle study. Our primary outcome will be a liberal salt diet systolic blood pressure with a secondary outcome of salt sensitive blood pressure. Therefore, this mechanistic trial will provide support for using a genetic marker that identifies individuals who are uniquely responsive to mineralocorticoid receptor blockade--personalized, precision medicine.
15895754|NCT03683056|Behavioral|I Can Problem Solve (ICPS) Program|The 59 sessions of ICPS program explicitly promote cognitive regulation, solving social problems, and emotional learning skills.
15895755|NCT03683043|Drug|Long GnRH agonist protocol|"8. The patients follow long protocol, which includes down regulation starting on day 21 of the previous cycle. The patient is seen after 14 days to confirm down regulation. Serum E2 ≤ 50 pg/ mL and no ovarian cysts observed in transvaginal US.
~9. Induction is started on day 3 of the current cycle by gonadotrophins (FSH and LH) daily IM or SC injections provided that the different preparations at the market can be used."
15895756|NCT03683043|Procedure|Embryo transfer|Cusco speculum was used to allow access to the cervix. The vagina was flushed by saline, and the cervical mucus is removed by Q-tips and/ or suction tubes. In few cases, where patients had long vaginae; two Sims' speculums were used to spread the vaginal anterior and posterior vaginal walls apart. In these cases, the attending nurse assisted the gynecologists during transfer The gynecologist asks the embryologist to load the embryos in the transfer catheter, and the gynecologist receives the loaded catheter from a window connecting the lab and operating room. In cases of trans-vaginal ultrasound guided embryo transfer the embryologist hands in the catheter to the gynecologists in the outer sheath and the gynecologist injects slowly the fluid containing the embryo/s. All patients are asked to rest for 30 minutes after the transfer
15917231|NCT03518112|Drug|Mercaptopurine|Given PO
15895759|NCT03683017|Device|OrthoPulse 2.1|Patients are given OrthoPulse 2.1, an extended OrthoPulse device with zone control (ability for doctor to control treatment regions). Patients complete 10 minute treatments (5 minutes each arch) every day.
15895760|NCT03683017|Device|Invisalign 3.5 Day Wear|Patients are are fitted with sets of clear orthodontic Aligners by a qualified Principal Investigator (PI) using a ClinCheck plan by Align Technology. Aligners are worn for approximately 22 hours a day, and switched every 3.5 days.
15895761|NCT03683017|Device|Fixed Orthodontic Appliances (Braces)|Patients are fitted with a set of brackets and wires, as per standard orthodontic treatment by a qualified Principal Investigator (PI).
15895762|NCT03682991|Other|Aggressive Risk Factor Control|"Sleep apnea screening, therapy is recommended if apopnea-hypopnea (AHI) index is greater than 15, with a target index of less than 5.
~Counseling regarding alcohol reduction to 2 drinks/day for men, 1 drink/day for women, no binge drinking (>5 drinks at one setting).
~Participation in a 12 week structured, home-based exercise program and nutritional counseling. Weight reduction will be emphasized through modification of diet and exercise.
~Blood Pressure management to achieve a target systolic blood pressure (SBP) of <120/80 mm/Hg
~Smoking cessation facilitated through local resources already established at each site"
15895763|NCT03682991|Other|Standard of Care|Recommendations based on current guidelines
15895764|NCT03682978|Drug|Arbaclofen|Arbaclofen tablet.
15895765|NCT03682978|Drug|Placebo|Placebo tablet.
15895766|NCT03682965|Biological|Intra-lymphatic allergenic extract|Mountain Cedar pollen allergenic extract is an FDA-approved, commercially available product for diagnosis and hypo-sensitization treatment of allergies. The labeled use is deep subcutaneous or percutaneous injection. Hyposensitization treatment is typically a series of 30 - 70 injections over 3 - 5 years into the upper aspect of the arm. This investigation is a proof-of-concept study to evaluate an alternative hyposensitization regimen of 3 injections directly into an inguinal lymph node.
15895767|NCT03682965|Biological|Intra-lymphatic placebo|The control group will receive a regimen of 3 injections of diluent (placebo) directly into an inguinal lymph node on the same schedule as the active treatment group.
15895768|NCT03682952|Drug|Alprostadil Injection|Participants are given alprostadil injection 10ug intravenously once a day for 2 weeks.
15895769|NCT03682952|Drug|Beraprost sodium tablets|Participants are given alprostadil injection 10ug intravenously once a day for 2 weeks ,then they take beraprost sodium tablets 40ug orally three times perday for 3 months.
15895770|NCT03682939|Biological|Bexsero® (meningitis B vaccine)|Bexsero® 0.5ml IM vaccine administered into non-dominant arm of participant
15895771|NCT03682939|Biological|Menveo® (meningitis ACWY vaccine)|Menveo® 0.5ml IM vaccine administered into dominant arm of participant
15895772|NCT03682926|Other|Electro-stimulation|Intracavitary electrostimulation with Quark medical vaginal electrode for perineal muscle strengthening protocol.
15895773|NCT03682913|Behavioral|P-CIT protocol|Personalized inhibitory control training for one week.
15895774|NCT03682913|Behavioral|Placebo|without personalized inhibitory control training for one week.
15895775|NCT03682900|Other|Click City Tobacco Prevention Program|Fifth and sixth grade classroom tobacco prevention computer activities designed to postpone or prevent youth smoking, through changing theoretically-based risk factors predictive of subsequent use.
15895776|NCT03682887|Procedure|Cryoballoon PV isolation group|"Pulmonary vein isolation will be performed using a cryoballoon catheter.
~Esophageal temperature will be monitored to prevent esophageal injury.
~A 28mm cryoballoon catheter will be used.
~Cryoablation will be performed for 180 secs at -30 C or below on condition that the pulmonary vein is occluded with a cryoballoon.
~CMAP (compound motor action potential) monitoring will be done to avoid phrenic nerve damage during the freezing of the right superior pulmonary vein.
~The procedure and ablation times will be evaluated.
~The procedure will be completed without checking any other trigger came from beyond pulmonary vein after the administration of isoproterenol
~Rhythm follow-up will be performed after the procedure in accordance with the aforementioned study design."
15895777|NCT03682887|Procedure|Cryoballoon PV isolation with Additional RA linear ablation group|It is a percutaneous catheter procedure to ablate the source of atrial fibrillation. By femoral vein access, the investigators conduct trans-septal puncture and introduce cryoballoon catheter into left atrium. Because the main foci of atrial fibrillation is pulmonary veins, the investigators isolate 4 pulmonary veins by freezing with cryoballoon catheters. However, in the discovery arm, the investigators conduct additional linear ablation on right atrial cavotricuspid isthmus and septum to reduce potential recurrence in patients with persistent atrial fibrillation.
15895778|NCT03682861|Behavioral|20 km time trial performance|20 km time trial cycling test will be conducted to measure the effect of different drinks on time
15895779|NCT03682861|Behavioral|Glycogen lowering exercise|Glycogen will be lowered using a 10-min warm-up period at a workload of 50% max wattage power output (Wmax). Thereafter, participants will be instructed to cycle 2-min block periods at alternating workloads of 90% and 50% of Wmax, respectively. This will be continued until the participants are no longer able to complete the 2 min at 90% Wmax. That moment will be defined as the time at which the individual is unable to maintain cycling speed at 60 revolutions/min. At that moment the high-intensity block will be reduced to 80% Wmax. Again, athletes will cycle until they are unable to complete a 2-min block at 80% Wmax, after which the high-intensity block will be reduced to 70% Wmax. Finally, participants will be allowed to stop when pedalling speed could not be maintained at 70% Wmax.
15895780|NCT03682848|Drug|DTG + 3TC FDC|DTG + 3TC FDC will be available as 50/300 milligrams tablet to be given orally once daily.
15895781|NCT03682835|Dietary Supplement|FDGard|capsule containing peppermint oil and caraway oil
15895782|NCT03682835|Other|Placebo|Placebo capsule containing cellulose
15895783|NCT03682822|Procedure|Early Artificial rupture of membranes|Women in this arm will undergo artificial rupture of membranes before 4 cm of cervical dilation is reached during induction of labor as long as the procedure is deemed clinically safe and feasible.
15895784|NCT03682822|Procedure|Delayed Artificial rupture of membranes|Women in this arm may undergo artificial rupture of membranes performed only after 4 cm of cervical dilation is reached during induction of labor. Rupture may also be performed after 10 hours of oxytocin administration with no cervical change.
15895785|NCT03682809|Drug|Systane Complete|Systane Complete is an artificial tear indicated for patients who have evaporative, aqueous deficient, or mixed dry eye.
15895786|NCT03682796|Drug|TRPH-222|administered by IV, 21-day Cycle
15895796|NCT03682705|Drug|Placebo for elsubrutinib|Placebo capsule for elsubrutinib will be administered orally.
15895797|NCT03682705|Drug|Placebo for upadacitinib|Placebo tablet for upadacitinib will be administered orally.
15895798|NCT03682692|Drug|ACEI/CCB|benazepril 10 mg / amlodipine besylate 5 mg fixed-dose combination
15895799|NCT03682692|Drug|ACEI/DIU|benazepril 10 mg / hydrochlorothiazide 12.5 mg fixed-dose combination
15895800|NCT03682679|Diagnostic Test|Sonoelastography|This diagnostic test would be executed by a physician who has experiences of using Siemens Acuson S2000 ultrasound system for more than three year. The examination includes two of four rotator cuff muscles, listed as follows, supraspinatus muscle and infraspinatus muscle. Linear transducer (4-9 MHz) would be used for the whole test. The probe would be positioned along the longitudinal axis of the muscle belly. Compressive sonoelastography technique is used for semiquantitative analysis. In order to maintain the quality of images, quality factor needs to be over or equal to 60. The quantitative analysis was performed by shear wave sonoelastography and the region of interest (ROI) would be divided into four quadrants. The physicians will measure the shear wave velocity at the center point of each quadrant.
15895801|NCT03682666|Device|Kinesiotaping|Kinesio tape would be applied over the extensor muscles of the affected hand for facilitating the extension of hand. We will apply the tape from the upper 1/3 length of dorsal side of the forearm and split the tape into five equal bars to the distal interphalangeal joint of each finger along the finger bones. This intervention would be executed for five days per week for three weeks.
15895802|NCT03682666|Behavioral|modified Constraint Induced Movement Training|A 2-hour time period would be arranged to constraint patient's unaffected hand by using a bandage by a therapist. During this two hours, patients would not be allowed to use this unaffected to do any activity, so that they will need to use the affected hand. The caregivers would also be educated to provide less help if it is not necessary. This intervention would be executed two hours a day for five days per week, for three weeks.
15895803|NCT03682666|Device|Sham taping|A short piece of kinesio tape would be cut into half and applied over the lateral side of the forearm from the lateral epicondyle till the half of the forearm. The tape would not cover the both the flexor and extensor muscle bellies.
15895804|NCT03682653|Drug|Azithromycin|a single dose of Azithromycin will be administered to infants between their 8-27th days of life
15895805|NCT03682653|Drug|Placebo|a single dose of Placebo will be administered to infants between their 8-27th days of life
15895806|NCT03682640|Drug|Azithromycin Monohydrate|Azithromycin Monohydrate tablet (Azithromycin Sandoz) or oral suspension (Azithromax).
15895807|NCT03682640|Drug|Insulin Lispro|Solution for intravenous or subcutaneous use
15895808|NCT03682640|Behavioral|Dietician support|Dietary advice
15895809|NCT03682627|Procedure|Fenestration|A standardized fenestration of the peritoneum will be performed. A 2 cm incision will be made in the peritoneum that is parallel to the skin incision after the transplant procedure. The peritoneal will not be sutured at the edges to keep the fenestration open. No interpositioning of the omentum will be performed.
15895810|NCT03682627|Procedure|Fenestration and clipping|A standardized fenestration of the peritoneum will be performed. A 2 cm incision will be made in the peritoneum that is parallel to the skin incision after the transplant procedure. The window edges will be clipped after fenestration using 8 metal clips.
15895811|NCT03682614|Drug|HCG|we will use the catheter to pass through the cervix, and after that, the experiment Group will accept 40 μl 500 IU HCG injection into the uterine cavity 2 days before the blastocyst transfer.
15895812|NCT03682614|Other|culture medium|The placebo group will accept 40 μl of culture medium injection into the uterine cavity 2 days before the blastocyst transfer.
15895813|NCT03682601|Drug|5% sinecatechins ointment|Topical 5% sinecatechins ointment will be applied once daily.
15895814|NCT03682601|Drug|Placebo|Aquaphor/vehicle
15895815|NCT03682601|Drug|10% sinecatechins ointment|Topical 10% sinecatechins ointment will be applied three times per week up to once daily.
15895816|NCT03682588|Other|Physical activity|The Functional exercise group performed functional exercise training for 45 minutes twice a week for 14 weeks. The Stretching exercise group performed stretching exercises with the same duration and frequency.
15895817|NCT03682575|Other|Enrollment|All infants whose families consent will be enrolled and will all receive the same treatment which included measurements of work of breathing.
15895818|NCT03682562|Diagnostic Test|DNA Integrity Index|"This test will be performed for ALL three groups:
~Sample collection:
~Patients will be given a sterile cup containing 5mL saline solution with which they will vigorously rinse their mouth while rubbing their tongues against the oral mucosa for 30 seconds, then spit it back into the cup. The solution will then be used for DNA extraction.
~DNA integrity analysis:
~The DNA integrity will be done through measuring a housekeeping gene using competitive polymerase chain reaction where the isolated DNA will be combined with DNA capture probes for sequence-specific DNA fragments. The DNA integrity index will be calculated as the ratio of the concentration of longer DNA fragments to the ratio of shorter ones."
15895819|NCT03682549|Diagnostic Test|Oral microbiome analysis|Oral swab from the buccal mucosa will be obtained and then analysed Oral Microbiome analysis:The microbial RNA will be sequenced using Next Generation Sequencer.
15895820|NCT03682536|Drug|Luspatercept|Luspatercept
15895821|NCT03682536|Drug|Epoetin alfa|Epoetin alfa
15895822|NCT03682523|Behavioral|Sedentary behavior reduction intervention|Participants will be provided with a device to measure physical activity and sedentary behaviours. A tablet will be placed in the participants' hospital room and synced to the device to provide real-time feedback. The research team will deliver an upright time goal and will target a 20% increase in upright time from the previous hospital day. Physiotherapist research assistants will visit the participants every afternoon to monitor progress and safely mobilize participants to their maximum ability if they have not met their daily goal (including weekend). The maximum level of ability will be determined in consultation with the healthcare team. Participants who do not meet their goal will be mobilized in the afternoon and early evening.
15895823|NCT03682510|Procedure|stepwise devascularization|stepwise devascularization begins with suture the placenta bed through uterine artery ligation, internal iliac artery ligation etc
15895864|NCT03682211|Drug|Fentanyl Citrate|50 μg/ml fentanyl citrate (Sublimaze, Janssen Cilag, Ltd, Marketing Authorisation No. PA 0748/044/001) administered intranasally using the MAD Nasal Intranasal Mucosal Atomiser Device
15917232|NCT03518112|Drug|Methotrexate|Given IT or IV
15895824|NCT03682510|Procedure|B-Lynch Transverse Compression Suture group|"After acceptable control of bleeding from the placental bed, uses the suture material 1 VICRYL with a 70mm ½ circle needle mounted on a 90 cms VICRYL suture. We use the needle blunt ended to puncture the uterus 3 cms above the upper margin of the incision posteriorly and behind the vascular bundle.
~The needle is retrieved through the cavity of the uterus and pulled inferiorly with the suture material lying on the posterior wall of the uterine cavity. The needle then perforates the posterior wall of the uterus 3 cms below the inferior margin of the Caesarean incision and exists behind the vascular bundle of the same side of the uterus retrieved and runs on the surface of the lower segment below the incision margin parallel to it and taking a 1 cm bite of tissue for stabilization running to the other side. After encircling the para-uterine vasculature, the needle then perforates the posterior side of the uterus behind the vascular bundle entering the uterine cavity."
15895825|NCT03682510|Procedure|N&H sandwich technique|In the N&H group, double uterine compression suture at the lower uterine segment with inflated Foley's catheter balloon tamponade.
15895826|NCT03682497|Drug|AZD9977|AZD9977 capsules taken orally for 28 days.
15895827|NCT03682497|Drug|Spironolactone|Spironolactone tablets taken orally for 28 days.
15895828|NCT03682484|Drug|MA-0211|oral
15895829|NCT03682484|Drug|Placebo|oral
15895830|NCT03682471|Drug|Deoxycholic acid Injection|Solution for subcutaneous injection.
15895831|NCT03682471|Drug|Placebo|Placebo, 10 mM sodium phosphate, 0.9% [w/v] sodium chloride in water for subcutaneous injection.
15895832|NCT03682458|Genetic|Study of Neurodegenerative Diseases Induced Stem Cells|The aim of this study is to generate iPS-induced stem cell lines from patients with neurological and neurodegenerative diseases to differentiate into neurons and glial cells to study the pathological cellular and molecular processes of these diseases. These in vitro cultures will also be used to validate molecules or experimental therapeutic approaches. IPS cells will be generated by the reprogramming of isolated 10-mL cells of peripheral venous blood.
15895833|NCT03682445|Other|exercise|Aerobic tyep of exercise will be made at different intensities in 2 groups.
15895834|NCT03682419|Procedure|VKA Patients|Venepuncture and capillary blood collection from Patients receiving Warfarin Therapy
15895835|NCT03682419|Procedure|Non-VKA Patients|Venepuncture and capillary blood collection from Patients not receiving Warfarin Therapy
15895836|NCT03682406|Behavioral|CAMS-G|Group-based suicide-specific intervention based upon the Collaborative Assessment and Management of Suicidality.
15895837|NCT03682393|Drug|Hydrocortisone|100mg 1x3 hydrocortison intravenously for three days after mitral valve surgery or until atrial fibrillation onset
15895838|NCT03682393|Drug|Placebos|100mg 1x3 intravenous fysiologic saline for three days after mitral valve surgery or until atrial fibrillation onset
15895839|NCT03682380|Drug|Seltorexant High Dose|In Part 1, Part 2, and Part 3 (3A and 3C), Seltorexant high dose (either a high dose tablet or two low dose tablets) will be administered orally.
15895840|NCT03682380|Drug|Seltorexant Low Dose|In Part 3 (3B and 3C), Seltorexant low dose will be administered orally.
15895841|NCT03682367|Drug|Gabapentin|Use of Gabapentin peri- and post-operatively.
15895842|NCT03682367|Drug|Placebo - Concentrate|Use of sugar-free Placebo peri- and post-operatively.
15895843|NCT03682354|Drug|Intercostal Nerve Block with PCIA|Intercostal nerve block consists in the injection of Ropivacaine (4 ml,0.5%) in related intercostal spaces. Patient-controlled intravenous analgesia regimen is conducted with sufentanil.
15895844|NCT03682354|Drug|Erector Spinae Plane Block (ESPB)|Erector Spinae Plane Block consists in the injection of Ropivacaine (20ml, 0.5%), in the anatomical plane between the Erector Spinae muscles and transverse process, laterally to the spinous process of T5 . The catheter was inserted and secured in place under ecographic guidance, and a patient-controlled regional anesthesia regimen was conducted with 0.2% ropivacaine.
15895845|NCT03682341|Genetic|endometriosis|patients with or without ovarian endometriosis
15895846|NCT03682328|Procedure|vertebroplasty|Cement augmentation of the vertebral body
15895847|NCT03682328|Procedure|kyphoplaty|Cement augmentation of the vertebral body
15895848|NCT03682315|Device|Biphasic phycogenic biomaterial|Maxillary sinus floor elevation and bone grafting with the use of biphasic phycogenic biomaterial combined with autogenous cortical bone
15895849|NCT03682315|Device|Xenograft bovine hydroxyapatite|Maxillary sinus floor elevation and bone grafting with the use of xenograft bovine hydroxyapatite combined with autogenous cortical bone
15895850|NCT03682302|Drug|Exparel|EXPAREL 4mg/kg (maximum 266 mg)
15895851|NCT03682302|Drug|0.5% Bupivacaine HCl|Bupivacaine HCl 2mg/kg
15895852|NCT03682289|Drug|ATR Kinase Inhibitor AZD6738|Given by mouth
15895853|NCT03682289|Drug|Olaparib|Given by mouth
15895854|NCT03682276|Biological|Ipilimumab|Ipilimumab is a monoclonal antibody given as an immunotherapy
15895855|NCT03682276|Biological|Nivolumab|Nivolumab is a monoclonal antibody given as an immunotherapy
15895856|NCT03682263|Behavioral|Full Service|Receive Individual Placement and Support (IPS) model of employment services, behavioral health services, care management services, and Medication Management Support provided by a Nurse Care Coordinator (NCC).
15895857|NCT03682263|Behavioral|Basic Service|Receive Individual Placement and Support (IPS) model of employment services, behavioral health services, and care management services.
15895858|NCT03682250|Device|FreeStyle Libre Pro|A FreeStyle Libre Pro will be used to identify hypoglycemic episodes
15895859|NCT03682250|Device|Holter monitor|A Holter monitor will be used to measure heart's activity
15895860|NCT03682237|Device|Carbohydrate counting, automated bolus calculation|Group training in carbohydrate counting and bolus calculation. The app MySugr will be taught and downloaded on own smart phone and person specific parameters will be estimated and entered in the app with the patients. SMBG measures at least 4 times daily with patients own preferred glucose meter.
15895861|NCT03682237|Device|Flash glucose monitoring (FGM)|Group training, patients will be instructed to use unblinded FGM for the whole study period. Patients are recommended to measure SMBG according to FGM manufactures guideline and handling of trend arrows etc.
15895862|NCT03682224|Drug|Liposomal Bupivacaine|Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site
15895863|NCT03682224|Drug|Bupivacaine-Epinephrine|Bupivacaine-Epinephrine 0.25%, 1:200,000 (Marcaine with epinephrine), administered subcutaneously at port site
15895865|NCT03682211|Drug|Morphine sulphate|10 mg/ml Morphine sulphate BP (Antigen Pharmaceuticals, Marketing Authorisation No.PA 73/20/1) administered intravenously.
15895866|NCT03682198|Device|NIRS measurements on skin, skull and dura|During a neurosurgical procedure, we will measure the brain oxygenation with a NIRS-electrode, first on forehead skin, then on the skull and finally directly on dura.
15895867|NCT03682198|Drug|Phenylephrine's effect on brain oxygenation|With a Clark-electrode (Licox(R)) in the white matter and a NIRS-electrode on the forehead skin, we will give a small dose (0.1 mg iv.) Phenylephrine.
15895868|NCT03682198|Drug|Normal vs. high inspired oxygen|By the end of the neurosurgical procedure, still with a Clark-electrode in the white matter and a NIRS-electrode on forehead skin, we will change the inspired oxygen fraction from 0.3 to 0.8.
15895869|NCT03682185|Behavioral|Attention-Control Condition|This condition will contain no active elements beyond its nonspecific components, and no theoretical basis to support an effect on CRDs. The attention-control group will also involve 4 in-home visits and 4 brief telephone education sessions. The attention control group will receive printed educational and training materials from the Alzheimer's Association and the NIH on home modification, health promotion, talking to your doctor, and advanced care planning that coincide with session content.
15895870|NCT03682185|Behavioral|Timed Activity Intervention|The timed activity group will involve 4 in-home visits and 4 brief telephone education sessions provided over 4 weeks. The timed activity intervention provides activities delivered at specific times in the daily cycle. The in-home sessions are spaced weekly so that the participants can have the opportunity to practice the activity with the interventionist and then on their own. During each session, the interventionist will reinforce activity use, review problem-solving approaches, and provide education.
15895871|NCT03682172|Drug|GLP-2 (1pmol/kg/min)|Four hour intravenous infusion with glucagon-like peptide 2 at a rate of 1pmol/kg/min
15895872|NCT03682172|Drug|GLP-2 (10pmol/kg/min)|Four hour intravenous infusion with glucagon-like peptide 2 at a rate of 10 pmol/kg/min
15895873|NCT03682172|Drug|Placebo|Four hour intravenous infusion with saline water
15895874|NCT03682159|Other|manual lymphatic drainage|The intervention group received the same conventional postoperative cares as the control group, but also underwent 5 sessions of manual lymphatic drainage (MLD)
15895875|NCT03682146|Procedure|Prostatectomy|Comparison of robot-assisted and conventional laparoscopic radical prostatectomy
15895876|NCT03682120|Biological|A/H7N9|"Monovalent inactivated, subunit influenza virus vaccine containing the HA and NA from influenza A/Hong Kong/125/2017 (H7N9) and the PB2, PB1, PA, NP, M and NS genes from A/Puerto Rico/8/1934 (H1N1)."
15895877|NCT03682120|Drug|MF59|Microfluoridized adjuvant 59 (MF59) is an oil-in-water emulsion.
15895878|NCT03682120|Other|Phosphate Buffered Saline (PBS) diluent|Diluent for Influenza Virus Vaccine.
15895879|NCT03682107|Biological|Andes virus DNA vaccine|A vaccine targeting the hantavirus pulmonary syndrome (HPS) causative agent Andes Virus (ANDV), with potential pan-hantavirus effect. The plasmid backbone, pWRG7077, is modified to produce the active ingredient of the vaccine, plasmid pWRG/AND-M (opt2), and includes the ANDV M gene responsible for encoding viral GnGc envelope glycoproteins. ANDV DNA vaccine will be administered intramuscularly at 2 mg or 4 mg doses using the PharmaJet Stratis Needle-Free Injection System.
15895880|NCT03682107|Other|Placebo|Normal saline injections will be administered intramuscularly as matching placebo using the PharmaJet Stratis Needle-Free Injection System
15895881|NCT03682094|Drug|VSL#3|Probiotics are dietary supplements composed of live microorganisms that are normally found within the human microbiome. Probiotics, specifically Lactobacilli and Streptococcus salivarius, have been shown to alter oral microbial composition and to inhibit oral pathogens that contribute to dental caries and periodontal disease. The probiotic chosen for this study is VSL#3, a blend of 8 strains of bacteria, including Lactobacillus and Streptococcus salivarius. VSL#3 has been well tolerated, with minimal adverse effects. VLS#3 was chosen as the treatment substance for this project due to its successful use in trials examining an array of outcomes and its combination of several strains of bacteria.
15895882|NCT03682081|Device|Isometric tongue strengthening facilitated by Iowa Oral Performance Instrument (IOPI)|An air-filled pressure bulb is placed on the surface of the oral tongue and pressed against the hard palate during exercise. Each patient is given a target pressure value to aim for as determined by the baseline one repetition maximum (1RM) lingual pressures. During week one of the regimen, the target value of each repetition will be 60% of the 1RM. For the remaining seven weeks, the target value will be increased to 80% of the 1RM. At weeks three, five, and seven, the baseline will be re-measured by phone and the 80% target value re-calculated.
15895883|NCT03682081|Device|Biotene Oral Balance Gel|Participants will be instructed to apply an amount equivalent to about 1 cm of Biotene® Oral Balance Gel with a finger to the tongue and most intensely affected areas of the oral cavity three times a day after brushing their teeth for 8 weeks.
15895884|NCT03682068|Drug|Durvalumab|Durvalumab IV (intravenous infusion)
15895885|NCT03682068|Drug|Tremelimumab|Tremelimumab IV (intravenous infusion)
15895886|NCT03682068|Drug|Cisplatin + Gemcitabine|Cisplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.
15895887|NCT03682068|Drug|Carboplatin + Gemcitabine|Carboplatin IV (intravenous)+ Gemcitabine IV(intravenous), as standard of care.
15895888|NCT03682055|Drug|VK-2019|EBNA1 inhibitor
15895889|NCT03682042|Other|Umbilical Cord Milking|At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 10-15 seconds.
15895890|NCT03682029|Dietary Supplement|Vitamin C (ascorbic acid)|Monotherapy with oral vitamin C supplementation to elevate plasma vitamin C level to the upper end of the physiological range.
15895891|NCT03682029|Other|Placebo|Placebo
15895892|NCT03682003|Diagnostic Test|blood diagnostic tests|blood tests are performed to determine hepcidin, IL-6, CRP, PCT, serum iron, ferritin, transferrin and transferrin saturation
15895893|NCT03681990|Drug|3M CHG/IPA Prep|Apply topically to intact skin
15895894|NCT03681977|Device|Zimmer MP Persona|The medial pivot Persona® knee implant with a Medial Congruent™ Bearing
15895895|NCT03681977|Device|Zimmer Persona Knee-PS|Persona the personalized knee system
15896068|NCT03680521|Drug|Nivolumab|Nivolumab administered as 240 mg IV every 2 weeks for 4-6 weeks in segment 2.
15896069|NCT03680508|Drug|TSR-022 and TSR-042|immunotherapy
15895896|NCT03681951|Drug|GSK3145095|GSK3145095 will be available as capsule (size 1 containing 5 to 25 mg GSK3145095 and size 0 containing 25 to 75 mg GSK3145095) or tablet (25, 50, 200 mg white to slightly covered round/oval shaped coated) for oral administration in the fasted stated with approximately 200 milliliters (mL) of water.
15895897|NCT03681951|Drug|Pembrolizumab|Pembrolizumab will be available as solution for infusion (100 milligrams/ 4 milliliter) at a dose of 200 mg via IV infusion for 30 minutes (given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted i.e., infusion time is 25 to 40 minutes).
15895898|NCT03681938|Procedure|Autograft|Autograft
15895899|NCT03681925|Diagnostic Test|Nutrition Literacy Assessment Instrument (NLit)|The NLit is a 64-question survey broken into 6 subscales. each subscale examines a different aspect of nutrition literacy (Nutrition and Health, Energy Sources in Food, Household Food Measurement, Food Label and Numeracy, Food Groups, and Consumer Skills). Global and subscale NLit scores will be generated for each participating patient.
15895900|NCT03681912|Behavioral|Competency: 12-Item Motivational Interviewing (MI) Coach Rating Scale (CRS)|"Coaching feedback will be triggered by a provider falling below the competency threshold on the standardized patient interaction. Everyone will receive coaching for two assessments in the month following training. After that, if mean scores fall below competency, then the provider will receive a 45-minute coaching session by the external Motivational Interviewing Network of Trainers (MINT) facilitator.
~Feedback on two highest and two lowest ratings, review of the audio recording and interactive coaching activities (e.g., fidelity assessments) targeting the lowest ratings. While many aspects of this implementation strategy are adaptable, organizational leadership will review data on completion of coaching feedback sessions and will determine corrective action for suboptimal adherence."
15895901|NCT03681912|Behavioral|Randomized Guided Development of COPs with an internal facilitator after one year of implementation.|Development of the CoP will be guided by scheduling and assisting in setting the agenda for the first three meetings to encourage MI practice, peer coaching and potentially fidelity monitoring, and prevent drift. In addition to CoP, half the sites will be randomized to receive an internal facilitator who will be trained to continue quarterly fidelity monitoring and coaching feedback when scores fall below competency.
15895902|NCT03681912|Behavioral|CoP development without internal facilitation.|Development of the CoP will be guided by scheduling and assisting in setting the agenda for the first three meetings to encourage MI practice, peer coaching and potentially fidelity
15895903|NCT03681899|Other|Questionnaires|"Socio-demographic data (age, sex, place of residence, and family status, last occupation, existence or not of a primary caregiver (family and / or professional));
~Medical and surgical history (Charlson Comorbidity Scale);
~Assessment of oral/dental condition
~Record of drug treatments (number of oral medications per day, therapeutic class, number of daily intakes);
~Oral treatments intake modalities (galenic breakdown of one or more drugs, usual or occasional, modalities of rupture, person responsible for the drugs, mixing with food / drink);
~Autonomy evaluation (Lawton and Katz scales);
~Mobility assessment (anamnestic evaluation);
~Evaluation of Thyme (GDS 4 items);
~Psycho-behavioral disorders,
~Assessment of swallowing (presence of a diagnosis of dysphagia or suspicion based on anamnestic data)."
15895904|NCT03681886|Device|Harmoni Modular Intraocular Lens|Two-component system consisting of a base and a separate optic that allows for an intraoperative exchange of the optic only without direct manipulation of the capsular bag.
15895905|NCT03681886|Procedure|Optic Exchange|Removal of one optic and replacement with another for the purpose of improving refractive outcomes
15895906|NCT03681873|Diagnostic Test|Extremely Low Dose CT|Patients undergoing a clinically indicated chest CT will also undergo the extremely low dose CT
15895907|NCT03681860|Biological|ChAdOx185A|ChAdOx1 85A is an adenoviral vaccine based on a vector that is a chimpanzee adenovirus isolate Y25 expressing the M.tb antigen 85A. Adenoviruses are attractive candidates for use as viral vectors and have been used as vaccine vectors for a number of conditions; however, the use has been limited by the high level of anti-vector immunity present in humans in whom adenovirus is a ubiquitous infection. This has led to the consideration of simian adenoviruses, which are not known to cause pathology or illness in humans and to which the prevalence of anti-vector antibodies is low. The ChAdOx1 vector has been developed by the University of Oxford and been used with different inserts for vaccination, for example the vaccine ChAdOx1 NP+M1 has demonstrated an excellent safety profile in the Influenza trial FLU004. A BCG - ChAdOx1 85A - MVA85A prime boost regime is more protective than BCG alone in mice.
15895908|NCT03681860|Biological|MVA85A|Modified vaccinia virus Ankara (MVA) is a highly-attenuated strain of vaccinia virus which cannot replicate in human cells. It is known to be highly immunogenic in UK adults but has been less immunogenic in African children and infants. It is suitable for use as a viral vector in a prime-boost regime in new vaccine development. It has an excellent safety record as it was administered intradermally to approximately 120,000 people during the smallpox eradication campaign, and has since been used in numerous clinical trials of candidate vaccines against viral, mycobacterial and protozoal infections.
15895909|NCT03681860|Biological|BCG|BCG is the only vaccine currently approved for use against Tuberculosis.
15895910|NCT03681847|Procedure|Normal saline|normal saline 0.9% 15 ml/kg over 15-20 minutes.
15895911|NCT03681847|Procedure|hydroxyethyl starch|hydroxyethyl starch 130/0.4 in 0.9 % sodium chloride 5 ml/kg over 15-20 minutes.
15895912|NCT03681847|Procedure|Hypertonic saline|hypertonic saline 3% (7ml/kg) over 15-20 minutes.
15895913|NCT03681834|Other|Data collection|Data on the effectiveness and safety of the Cor-Knot® knotting device
15895914|NCT03681821|Behavioral|Transtheoretical Model (TTM)-based Intervention|Patients in the intervention group had access to conventional care, in addition to receiving the follow-up TTM-based intervention sessions. The intervention was provided by trained nurses, including one researcher and one ET nurse. Sessions were held in the meeting room in the unit four times: at baseline (T0), 2 days before discharge (T1), and at 1-month (T2) and 3-months (T3) after discharge, according to the assessment of their current stage of change delivered by filling the Stages of Change Subscale. Each face-to-face group contact lasted about 1 hour, depending on the complexity of the patients' problems.
15895915|NCT03681808|Device|Control|Contact Lens
15895916|NCT03681808|Device|Test|Soft Contact Lens
15895917|NCT03681795|Diagnostic Test|Experimental MRI exam and PET scan exam with radiotracer|MRI exam and PET scan exam with radiotracer
15895918|NCT03681769|Device|iTBS to the left dlPFC|This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the Universal Serial Bus (USB) key).
15895919|NCT03681769|Device|Sham iTBS to the left dlPFC|This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.
15895920|NCT03681769|Device|cTBS to the mPFC|This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key)
15895921|NCT03681769|Device|Sham cTBS to the mPFC|This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.
15895922|NCT03681756|Behavioral|WALK|Walking program
15895923|NCT03681743|Device|Virtual Reality|Participants wear a Virtual Reality headset that consists of a ASUS phone and a VOX+ Z3 3D Virtual Reality Headset. The phone runs the VR Roller Coaster app to produce the virtual environment.
15895924|NCT03681730|Device|Virtual Reality|Participants wear a Virtual Reality headset that consists of a ASUS phone and a VOX+ Z3 3D Virtual Reality Headset. The phone runs the VR Roller Coaster app to produce the virtual environment.
15895925|NCT03681717|Device|Virtual Reality|Participants wear a Virtual Reality headset that consists of a ASUS phone and a ReTrack Utopia 360 VR Headset. The phone runs the VR Roller Coaster app to produce the virtual environment.
15895926|NCT03681704|Drug|HuangQi Decoction|HuangQi Decoction 150ml twice a day for 24 weeks
15895927|NCT03681704|Drug|HuangQi Decoction placebo|traditional Chinese medicine placebo mimic HuangQi Decoction 150ml twice a day for 24 weeks
15895928|NCT03681691|Drug|Estradiol patch|transdermal 17β-estradiol patch
15895929|NCT03681678|Device|fCO2 Laser Therapy Group|Women enrolled in the study will receive three treatments with the fractional carbon dioxide (fCO2) laser. The interval between treatments is approximately six weeks. Intra-vaginal laser treatments will be delivered at 8 points at each level of the vaginal wall.
15895930|NCT03681665|Other|ultralow dose abdominopelvic CT|In the patient cohort with abdominal abscess, ultralow dose abdominopelvic CT will be performed as a follow-up protocol. Ultralow dose CT has approximately 80~90% reduced radiation dose compared to standard dose CT.
15895931|NCT03681652|Drug|Azathioprine|Children with Crohn's disease who are treated with azathioprine for post-operative prophylaxis following ileo-cecal resection
15895932|NCT03681652|Drug|Anti-TNF Drug|Children with Crohn's disease who are treated with anti-TNF monotherapy for post-operative prophylaxis following ileo-cecal resection
15895933|NCT03681639|Diagnostic Test|Serum Metal ion levels determined to monitor changes in chromium and cobalt levels|Analyses will be performed pre-operatively, 6 months, 1 year, 2 years and 5 years postoperatively for all study subjects enrolled in this study, as well as, all revision study subjects receiving the Metasul® LDH™ total hip system. To prevent intra-observer variation the metal ion concentrations will be analysed by an approved Central Laboratory. The Central Laboratory will provide specimen collection kits for the transfer of blood specimens to the Laboratory for analysis. The Laboratory will provide the results to the Investigators. The cobalt and chromium will be measured by induced coupled plasma mass spectrometry (ICP-MS). BUN, creatinine and GFR will be determined locally.
15895934|NCT03681626|Procedure|no tracheal suction|No tracheal suctioning during extubation
15895935|NCT03681626|Procedure|tracheal suction|tracheal suctioning during extubation
15895936|NCT03681613|Other|NEMEX program combined with a CNS-focused protocol|"The NEMEX program will consist of 12-weeks of individualized and supervised exercise sessions applied twice weekly (n=24 sessions). Each exercise session will last approximately 60minutes and include three parts: warming up, a circuit program and cooling down.
~The CNS-targeted treatment will consist of 12-week individualized and supervised sessions applied once weekly. Each training session will last approximately 30 minutes and include three parts, which are further explained below: 1) discussion of the participant's knee pain experience from a pain neuroscience perspective, 2) graded SDT and 3) GMI training."
15895937|NCT03681613|Other|NEMEX program|The NEMEX program will consist of 12-weeks of individualized and supervised exercise sessions applied twice weekly (n=24 sessions). Each exercise session will last approximately 60minutes and include three parts: warming up, a circuit program and cooling down.
15895938|NCT03681587|Other|Control situation|"Standard breakfast usually offered monotonous control condition at the retirement home: the time of distribution, the duration of ingestion and the composition will be habitual. This meal and subsequent meals will be measured over 3 consecutive days with observation periods at breakfast time in order to identify the variables of pleasure, feasibility, commensality and conviviality in 2 situations: alone in the room or with others in the dining room."
15895939|NCT03681587|Other|Experimental situation|"Salty/sweet breakfast varied experimental situation: the time of distribution and the duration of mealtime will be open and the composition will be varied with sweet/savory foods. This meal and subsequent meals will be measured over 3 consecutive days with observation periods at breakfast time in order to identify the variables of pleasure, feasibility, commensality and conviviality in 2 situations: alone or in the room or with others in the dining room."
15895940|NCT03681574|Drug|Placebo Group|Patients will be submitted to either myelogram or lumbar puncture procedure. Before that they will receive placebo concentrate.
15895941|NCT03681574|Drug|GABA 15mg/kg Group|Patients will be submitted to either myelogram or lumbar puncture procedure. Before that they will receive gabapentin at 15mg/kg.
15895942|NCT03681574|Drug|GABA 30mg/kg Group|Patients will be submitted to either myelogram or lumbar puncture procedure. Before that they will receive gabapentin at 30mg/kg.
15895943|NCT03681561|Drug|Ruxolitinib|"Ruxolitinib at assigned dose* twice daily by mouth begin Day 1 and continuing daily until study treatment stop.
~Dose Levels:
~1 (starting) : 10mg twice daily 2: 15mg twice daily 3: 20mg: twice daily"
15895944|NCT03681561|Drug|Nivolumab|Nivolumab 480 mg IV every 4 weeks (Day 1) Until disease progression, unacceptable toxicity, patient refusal or a maximum of 2 years
15895945|NCT03681548|Drug|Doxorubicin Hydrochloride Liposome Injection|50mg/m2, IV on Day 1 of each cycle, On Day 1 of Cycle 1 patients will receive either reference or test product, On Day 1 of Cycle 2 , patients will crossover to the alternate reference or test formulation
15896070|NCT03680495|Drug|Methylprednisolone|1. Methylprednisolone is a steroid (corticosteroid) similar to a product produced in the adrenal glands. It is used to help relieve inflammation (swelling, heat, redness, and pain) and is used to treat certain medical issues including COPD.
15895946|NCT03681535|Radiation|Radiation Therapy|This phase II study will evaluate whether a reduction in the RT dose, concomitant with a decrease in the RT field size, in patients that achieve complete response and have a negative post-chemotherapy PET scan following 3 to 6 cycles of rituximab containing chemotherapy, will be associated with a low risk of in-field failure. The goal of this approach is to maintain excellent control rates while minimizing the risk of acute and late toxicity.
15895947|NCT03681522|Procedure|Pelvic plexus block|Injections of 2.5 mL of 2% lidocaine were made to the pelvic neurovascular plexus located at the end of the seminal vesicle under Doppler US guidance on each side
15895948|NCT03681522|Procedure|Periprostatic nerve block|Injections of 2.5 mL of 2% lidocaine were made to the neurovascular bundles at the junction of the prostate-bladder-seminal vesicle on each side.
15895949|NCT03681509|Drug|Pramipexole|Pramipexole
15895950|NCT03681509|Drug|Placebo|Lactose placebo capsule
15895951|NCT03681483|Drug|RO5126766|RO5126766 (CH5126766) is given 4mg twice weekly (Day 1 and Day 4 of each week) and should be taken by mouth on an empty stomach, either one hour before or two hours after a meal.
15895952|NCT03681470|Drug|Aczone Gel|Aczone Gel 7.5%
15895953|NCT03681457|Drug|LJN452|Dose A single dose
15895954|NCT03681444|Other|Regular diet|Patients will be provided with any type of food preferred at any time in any quantity
15895955|NCT03681444|Other|Clear fluid diet|"Patients will be provided with
~Plain water
~Fruit juices without pulp, such as grape juice, filtered apple juice, and cranberry juice
~Soup broth (bouillon or consommé)
~Clear sodas, such as ginger ale and Sprite
~Gelatin (Jell-O)
~Tea or coffee with no cream or milk added
~Sports drinks that don't have color"
15895956|NCT03681444|Other|Low residue diet|"The Low Residue Diet is the same as the soft diet with the added limitation of milk to one pint. It provides foods that are easily digestible. It is often used as a transition diet from liquids to the general diet. Indigestible fiber is reduced by using tender cooked vegetables and ripe, canned or cooked fruits from which the tough skins and seeds have been removed. Tender meat or meat made tender in the cooking process is used, thus reducing the amount of connective tissue.
~Adequacy: By following the recommended guidelines, the diet will be adequate according to the Recommended Daily Allowance.
~Note: For patients with dentures this diet can be modified by the substitution of ground meat for whole meat and excluding all raw vegetables. Personal tolerances determine food choices; avoid foods that cause GI (gastrointestinal) distress prior to the admission even though that food may be on the foods included list."
15895957|NCT03681444|Diagnostic Test|Colonoscopy|Colonoscopy will be performed under conscious sedation with intravenous midazolam and pethidine titrated as required
15895958|NCT03681431|Drug|Ceftriaxone 4g/ 24h|Each individual will be administrated 2 doses of 2 g of ceftriaxone separated for 12 hours. After a wash-out period (5-7 days) the same individuals will receive a single dose 4 g of ceftriaxone. In both cycles, plasma drug concentrations will be measure during 24 hours.
15895959|NCT03681431|Drug|Ceftriaxone 2g/ 12h|Each individual will be administrated 2 doses of 2 g of ceftriaxone separated for 12 hours. After a wash-out period (5-7 days) the same individuals will receive a single dose 4 g of ceftriaxone. In both cycles, plasma drug concentrations will be measure during 24 hours.
15895960|NCT03681418|Procedure|Ultrasound-guided axillary lymph nodes FNAC and\or CNB.|Ultrasound-guided axillary lymph node fine needle aspiration and\or core needle biopsy of the most suspicious lymph node. If all the lymph nodes appeared similar or normal, the lymph node that is lowest in the axilla will be selected because it is considered to most likely be the sentinel node.
15895961|NCT03681405|Other|Informational Intervention|Given information about mindful movement and breathing
15895962|NCT03681405|Other|Questionnaire Administration|Ancillary studies
15895963|NCT03681405|Behavioral|Telephone-Based Intervention|Receive caring attention phone call
15895964|NCT03681392|Dietary Supplement|Dr. Pyke's Supplement for Stream (S4S)|Proprietary combination of Panax ginseng extract, L-citrulline, beta-sitosterol and vitamin D3
15895965|NCT03681366|Device|DISC3.5 plus|The Defocus Incorporated Soft 3.5 Plus Contact Lens (DISC3.5 Plus) is a soft contact lens that comprises of simultaneous distance optical prescription and myopic defocus areas.
15895966|NCT03681353|Behavioral|Mobile Contingency Management, active|Participants are provided monetary reinforcement for providing oral fluid test results that suggest they have reduced cannabis use.
15895967|NCT03681340|Other|Hydroxyapatite toothpaste|If in a subject a significant increase of carious lesions will be observed, her/his parents are informed about the necessity for further caries preventive measures (e.g. dietary changes, use of fluoride products, reduction of cariogenic microflora with chlorhexidine, xylitol chewing gum, etc.) and caries preventive treatment (removing caries and placing a restoration) by the study centers is offered.
15895968|NCT03681340|Other|Fluoridated toothpaste|If in a subject a significant increase of carious lesions will be observed, her/his parents are informed about the necessity for further caries preventive measures (e.g. dietary changes, use of fluoride products, reduction of cariogenic microflora with chlorhexidine, xylitol chewing gum, etc.) and caries preventive treatment (removing caries and placing a restoration) by the study centers is offered.
15895969|NCT03681327|Other|Sensory stimulation during sleep|Sensory stimulation during sleep
15895970|NCT03681314|Other|Umbilical Cord Milking|At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 10-15 seconds.
15895971|NCT03681301|Other|virtual reality simulator|Additional self-directed learning and practice using virtual reality simulator
15895972|NCT03681288|Behavioral|Mindful Self-Compassion|Mindful Self-Compassion Intervention
15895973|NCT03681275|Drug|Tofacitinib 5 mg|administered twice daily for two days
15895974|NCT03681275|Drug|Placebo to match Tofacitinib|administered twice daily for two days
15895975|NCT03681262|Device|High frequency spinal cord stimulation|We will use Senza® (Nevro Corp., Palo Alto, CA) trial and implant systems to deliver high frequency spinal cord stimulation. A trial system includes two trial leads, an external pulse generator, and a remote control. The permanent implant system includes two leads, an internal pulse generator, a remote control, and a charging device for internal pulse generator. We will use our routine process of trial and implant. High frequency waveform will be delivered with following parameters: frequency of 10,000 hertz, pulse width of 20 microseconds, and amplitude of 0-15 milliamperes.
15896541|NCT03677076|Other|Ancillary/Correlative|Collection of research blood and urine
15895976|NCT03681262|Device|Burst spinal cord stimulation|We will use BusrtDRTM (Abbott Saint Jude Medical, St. Paul, MN) trial and implant systems to deliver burst spinal cord stimulation. A trial system includes two trial leads, an external pulse generator, and a remote control. The permanent implant system includes two leads, an internal pulse generator, a remote control, and a charging device for internal pulse generator. We will use our routine process of trial and implant. The parameters of the stimulation are as below: each burst includes 5 pulses of electrical stimulation at intra-burst frequency of 500 hertz without time for discharge in between pulses. These bursts will be repeated at inter-burst frequency of 40-60 hertz. The amplitude will range between 0 and 15 milliamperes.
15895977|NCT03681249|Drug|ShenqiDihuang Decoction|ShenqiDihuang Decoction 150ml twice a day for 24 weeks 150ml twice a day for 24 weeks
15895978|NCT03681249|Drug|ShenqiDihuang Decoction placebo|traditional Chinese medicine placebo mimic ShenqiDihuang Decoction 150ml twice a day for 24 weeks
15895979|NCT03681236|Procedure|Alveolar recruitment maneuver|Applying plateau pressure 30cmH₂O for 30 seconds to achieve alveolar inflation
15895980|NCT03681223|Device|Vertessa® Lite Y mesh|Via randomization, 50 surgical subjects will receive Vertessa® lite Y mesh for the treatment of vaginal vault prolapse. The patient will be blinded as to which mesh they receive.
15895981|NCT03681223|Device|Restorelle® Y mesh|Via randomization, 50 surgical subjects will receive Restorelle® Y mesh for the treatment of vaginal vault prolapse.The patient will be blinded as to which mesh they receive.
15895982|NCT03681223|Procedure|Laparoscopic sacrocolpopexy|The subject's surgeon will decide if their patient should have laparoscopic sacrocolpopexy upon their clinical evaluation
15895983|NCT03681223|Procedure|Robotic assisted laparoscopic sacrocolpopexy|The subject's surgeon will decide if their patient should have robotic assisted laparoscopic sacrocolpopexy upon their clinical evaluation
15895984|NCT03681210|Device|HeartWare Ventricular Assist Device|The HVAD is an implantable centrifugal rotary blood pump that is implanted in the pericardial space and is designed to provide up to 10 L/min of blood flow from the left ventricular to the aorta. The HVAD System is comprised of three major components: the HVAD (pump) with inflow and outflow conduits, a Controller (microprocessor unit that controls the operation of the HVAD), and power sources (AC and DC power adapters that provide power to the Controller and implanted HVAD).
15895985|NCT03681197|Drug|Metformin|Metformin 850 mg tablet will be started twice daily immediately at booking time and continued with induction by clomiphene citrate, it will be stopped once pregnancy is confirmed.
15895986|NCT03681197|Drug|Placebo|In placebo group,placebo will be strted twice daily at booking time and continued with induction by clomiphene citrate, it will be stopped once pregnancy is confirmed.
15895987|NCT03681197|Drug|Clomiphene Citrate|50 mg of clomiphene citrate will be given starting day 2 of menstrual cycle for 5 days
15895990|NCT03681171|Other|Therapeutic Dance|Participants attended therapeutic ballet sessions three times per week for six weeks.
15895991|NCT03681158|Drug|sodium valproate|Pharmaceutical form:Powder for oral solution reconstituted with water Route of administration: Oral
15895992|NCT03681145|Behavioral|Counselor delivered telehealth intervention|This is a technology-based counseling intervention for youth living with HIV (YLWH) focused on engagement in HIV care, mental health, and substance use challenges through text messaging and teleconferencing (telehealth). The intervention is delivered in 12 brief sessions.
15895993|NCT03681132|Other|Stop of therapy|The active intervention is to stop antiviral therapy, and delay re-start in the high-threshold group.
15895994|NCT03681119|Behavioral|Dementia symptom management at home hospice edition|Quality assurance performance improvement program
15895995|NCT03681119|Behavioral|Education and Training|Education and training
15895996|NCT03681106|Device|Kinesio Tex|Kinesio Tex tape on the operated limb
15895997|NCT03681093|Drug|Fevipiprant 150 mg|Fevipiprant (QAW039) 150 mg once daily administered orally as tablet
15895998|NCT03681093|Drug|Fevipiprant 450 mg|Fevipiprant (QAW039) 450 mg once daily administered orally as tablet
15895999|NCT03681093|Drug|Placebo|Placebo once daily administered orally as tablet
15896000|NCT03681080|Procedure|leg crossing|As Counter maneuvre legs will be crossed and cognitive tests will be performed.
15896001|NCT03681067|Drug|GSK1070806|GSK1070806 100mg/ml injectable solution will be delivered via intravenous infusion as a single infusion
15896002|NCT03681067|Drug|Placebo- sodium chloride|Placebo injectable solution will be delivered via intravenous infusion as a single infusion
15896003|NCT03681054|Other|Carbohydrate restricted diet|The intervention is implemented by individual face-to-face counseling and mobile-phone counseling by a nutritionist, as well as food bags and recipes suitable for the diet. Targets: fruits and vegetables 500 g/d, fish 2 times/wk, low-fat instead of high-fat meat, red meat ≤ 3 times/wk, low-fat instead of high-fat dairy, high-fibre instead of low-fibre grains, vegetable oils (excluding palm oil and coconut oil) and soft margarine instead of animal fats, moderate reduction of carbohydrates (targets for macronutrients: carbohydrates 40 E%; fat 40 E%; protein 20 E%; dietary fiber 32g, energy intake approximately 2000 kcal/d; protein intake 20 E%; sucrose: <10 E%; fatty acids: saturated fatty acids < 10 E%, polyunsaturated fatty acids 5-10 E% and the rest of fat as monounsaturated fatty acids)
15896004|NCT03681054|Other|Plant-protein based diet|The intervention is implemented by individual face-to-face counseling and mobile-phone counseling by a nutritionist, as well as food bags and recipes suitable for the diet. Targets: fruits and vegetables 1 kg/d; fish 3/wk; high-fibre grains, mainly rye, oat and barley; plant protein instead of meat protein; low-fat fermented dairy instead of other dairy; rapeseed oil and rapeseed-based margarine instead of other fats; no carbohydrate restriction (targets for macronutrients: carbohydrates 50 E%; fat 30 E%; protein 20 E%; dietary fiber 36g, energy intake approximately 2000 kcal/d; protein intake 20 E%; sucrose: <10 E%; fatty acids: saturated fatty acids < 10 E%, polyunsaturated fatty acids 5-10 E% and the rest of fat as monounsaturated fatty acids)
15896005|NCT03681041|Other|Standard treatment|Treatment according to guidelines for pancreatic trauma according to the Chinese Trauma Association and the American Association for the Surgery of Trauma
15896164|NCT03679780|Drug|BQ-788|This intervention is aimed at blocking endothelin type B receptors to assess racial differences during vasoconstriction. The infusion rate will be 2 µl/min
15896170|NCT03679767|Drug|Retifanlimab|INCMGA00012 administered intravenously at the recommended Phase 2 dose every 4 weeks.
15896006|NCT03681028|Drug|Individualized therapy|"For a given proposed individualized combination of drugs the first priority to establish doses will be to identify the same combination of drugs in a peer-reviewed journal article or presented as a reviewed abstract.
~When a proposed individualized combination of drugs has not previously been reported, the process to establish doses will be to then identify individual members of the proposed combination that have been used in combination with other cytotoxic agents similar to those being considered for combination therapy.
~When a proposed individualized combination of drugs has no available combination data, dosing guidelines will start with the FDA-approved package insert recommended dose."
15896007|NCT03681002|Behavioral|structured lifestyle program|Intensive Lifestyle counseling during one year
15896008|NCT03680989|Device|Bright Light Exposure|"For 10 consecutive days, participants will use an Ultralux(R) V HD-LED light therapy light for 30 minutes beginning 30 minutes after waking. The light will be preset to deliver ~10,000 lux at 22."
15896009|NCT03680989|Device|Natural Light Exposure|"For 10 consecutive days, participants will use an Ultralux(R) V HD-LED light therapy light for 30 minutes beginning 30 minutes after waking. The light will be preset to deliver ~500 lux at 22."
15896010|NCT03680976|Drug|CXA-10|Liquid-filled capsule containing 150 mg CXA-10 in super refined olive oil.
15896011|NCT03680976|Drug|Placebo|Liquid-filled capsule containing olive oil manufactured to mimic CXA-10 150 mg capsule
15896012|NCT03680963|Procedure|Non-invasive strategy|"No indwelling arterial catheter insertion will be allowed during the first 28 days, excepted if predefined safety criteria (indicating absolute need of indwelling arterial catheter insertion) are reached.
~In the non-invasive group, automated oscillometric monitor will be used to monitor BP (blood pressure)."
15896013|NCT03680963|Procedure|Control strategy|An indwelling arterial catheter will be inserted as soon as possible (within the first four hours after randomization) and will be maintained except in case of indwelling arterial catheter futility, suspected or proven indwelling arterial catheter related infection or thrombosis (at discretion of attending physician) until day 28 or ICU (Intensive Care Unit) discharge (whichever comes first). After day 28, clinicians may choose to maintain or to remove indwelling arterial catheter.
15896014|NCT03680950|Device|Upper Gastrointestinal Monitoring System|Participants will wear a monitoring system consisting of a tiny endoscopy and a mobile device. The endoscopy is inserted to upper gastrointestinal tract via nasal cavity and the mobile device is set to take and send images from the endoscopy to a server for analyzing if the abnormal condition occurs.
15896015|NCT03680937|Other|Gavi , Merck® (automated vitrification instrument)|Gavi, Merck ® permits semi-automated vitrification with closed system.
15896016|NCT03680937|Other|Vitrification|Group 1: immature ovocytes vitrified before IVM; Group 2: immature oocytes vitrified after IVM; Group3: fresh immature oocytes treated by IVM (without vitrification, control group).
15896017|NCT03680911|Drug|N Acetyl Cysteine|2 g PO BID for 4 days, then 1.5 g PO BID for 2 days
15896018|NCT03680911|Drug|Placebo oral capsule|2 g PO BID for 4 days, then 1.5 g PO BID for 2 days
15896019|NCT03680898|Device|Rectal swab collection|Patient will provide a rectal swab by following hospital-provided instructions.
15896020|NCT03680885|Drug|Lidocaine gel|Lidocaine gel 5%, PEG with FD&C Blue No.1 (Brilliant Blue FCF)
15896021|NCT03680885|Drug|Placebo|PEG with FD&C Blue No.1 (Brilliant Blue FCF)
15896022|NCT03680885|Drug|Injected lidocaine|Standard FDA-approved dental injectable lidocaine
15896023|NCT03680872|Device|Bidirectional Neural Bypass System|These participants will receive the investigational device called the Bidirectional Neural Bypass System. The study intends to use this device to restore volitional movement and sensation to the hand and wrist of an individual during its use in the laboratory.
15896024|NCT03680846|Device|HF10 Therapy|Senza 10 kHz Spinal Cord Stimulation
15896025|NCT03680846|Other|CMM|Conventional Medical Management
15896026|NCT03680833|Procedure|Sentinel node detection in cervical cancer|The study intervention is the injection of tracer followed by detection and removal of sentinel lymph nodes
15896027|NCT03680807|Diagnostic Test|Muscle function test|Power and strength tests of the knee-extensor muscles, handgrip strength, functional capacity tests
15896028|NCT03680794|Other|sampling of ophthalmic liquid|aqueous sampling for patients with cataract surgery or vitreous sampling for patients with posterior segment surgery
15896029|NCT03680781|Device|Intermittent theta-burst stimulation (iTBS)|"Participants will receive iTBS to the left DLPFC or bilateral DLPFC, to the right and left DLPFC. The DLPFC will be targeted utilizing either Localite's neuronavigation system or Nexstim's eField neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004).
~Stimulation will be delivered to the L-DLPFC or bilateral DLPFC using either a MagVenture MagPro X100 or a Nexstim TMS device."
15896030|NCT03680768|Other|Health Assessment|The protocol includes measurements of body composition, strength test, functional and fitness test as well as biochemical measurements from blood samples and AGEreader
15896031|NCT03680755|Behavioral|Internet-based intervention for dental anxiety|Participants will complete the experimental dental anxiety management program, which will be facilitated by a person trained in psychological treatments or by dental staff. This program consists of a series of videos which provide information about dental anxiety, educate about the details of three dental procedures which are anxiety-provoking for the participant, and teach them how to cope better with the dental experience. This program will take about 60 minutes to complete.
15896032|NCT03680742|Device|Contour Neurovascular System|The Contour Neurovascular System™ is an intrasaccular, self-expanding, embolization device intended for the treatment of unruptured intracranial aneurysms.
15896033|NCT03680729|Behavioral|Adapted Brothers Saving Brothers (aBSB)|This information is listed in the arm description.
15896034|NCT03680729|Behavioral|Standard Street Outreach|This information is listed in the arm description.
15896035|NCT03680716|Drug|Ropivacaine injection|Saphenous nerve block with 20ml of ropivacaine 0.5% and IPACK block with 30ml of ropivacaine 0.2% (total dose of 160 mg).
15896036|NCT03680716|Drug|Ropivacaine injection|Periarticular infiltration of 80 ml ropivacaine 0.2% (total dose of 160mg).
15896165|NCT03679780|Drug|BQ-123|This intervention is aimed at blocking endothelin type A receptors to assess racial differences during vasoconstriction. The infusion rate will be 2 µl/min
15896166|NCT03679780|Drug|L-Arginine|A substrate that is administered to increase endogenous nitric oxide production. The infusion rate will be 2 µl/min
15896037|NCT03680703|Behavioral|Guided Self-Help Behavioral Weight Loss|Participants will be provided with patient-focused materials and worksheets that contain all the necessary information, procedures, and techniques of the behavioral weight loss program. For 12 weeks, treatment will be provided over the internet. This therapy focuses on making gradual and modest lifestyle changes with goals of normalizing eating patterns, decreasing caloric intake, building coping skills, and increasing physical activity.
15896038|NCT03680690|Procedure|hysteroscopy|office hysteroscopy will be done for all candidates and operative correction of detected lesions will be carried on.
15896039|NCT03680677|Procedure|Bone Marrow or Peripheral Blood Graft (BMT)|Patient receives bone marrow or peripheral blood graft (BMT) on or off protocol.
15896040|NCT03680677|Other|Cancer-directed Therapy or Best Supportive Care|"Cancer-directed therapy with intensive regimens (7+3, Vyxeos, clofarabine, or similar), clinical trial, hypomethylating agent (azacitidine or decitabine), hypomethylating agent combinations (i.e. with venetoclax, sorafenib, enasidenib, ivosidenib, midostaurin, gilteritinib, or other targeted agent), targeted agents alone (i.e. enasidenib, ivosidenib, gilteritinib, midostaurin, etc.), or supportive care."
15896041|NCT03680677|Diagnostic Test|Frailty Assessment|Frailty is the vulnerability of older adults to adverse health outcomes in response to illness and iatrogenic stressors.
15896042|NCT03680664|Device|Active tDCS|Excitatory bilateral stimulation to the frontal lobes, in particular the left and right DLPFC, will be applied. The anode will be placed at Fz and the cathode at Iz to achieve this bilateral frontal excitatory stimulation. Rubber electrodes will be inserted in 35-cm2 saline-soaked sponges and fixed with a headband. The direct current will be of 2 mA (current density = 0.57 A/m2) for 30 min per day.
15896043|NCT03680664|Other|sham tDCS|The same tDCS parameters as as the active condition will be used; however, the device will be turned off after 1 minute of active stimulation.
15896044|NCT03680664|Behavioral|MBSR|After a brief orientation session, the MBSR sessions will be conducted in 8 weekly 2.5 hour classes plus a half-day retreat. Content includes instruction and guidance to mindfulness meditation practices, gentle mindful movement, and various exercises to enhance mindfulness in everyday life. Participants will get daily at-home assignments with CDs of meditative practice.
15896045|NCT03680638|Other|Control (Lactated Ringer's)|This intervention is meant to serve as a control by which the experimental sites are compared to, to assess effectiveness.
15896046|NCT03680638|Drug|Tempol|This intervention is meant to assess the impact of superoxide on vasodilator responses by scavenging available superoxide.
15896047|NCT03680638|Drug|Apocynin|This intervention is meant to assess the impact of NADPH oxidase-derived superoxide on vasodilator responses by inhibiting the enzyme NADPH oxidase.
15896048|NCT03680638|Drug|Allopurinol|This intervention is meant to assess the impact of xanthine oxidase-derived superoxide on vasodilator responses by inhibiting the enzyme xanthine oxidase.
15896049|NCT03680625|Device|Passive Distraction|Patients in this group will be offered an iPad® showing a video while they will undergo their pins' removal and/or removal of sutures. There will be videos appropriate for each age group. The child can choose from the videos presented on the iPad® and start watching 5 minutes before the beginning of the procedure to assure similar preparation for both groups.
15896050|NCT03680625|Device|Virtual Reality Distraction|Patients in this group will be offered virtual reality distraction through the use of Oculus Quest® while they undergo their pins' removal and/or removal of sutures. VR produces a high level of immersion, with high photorealism while maintaining the low latency necessary to induce presence and prevent cybersickness symptoms such as nausea, vomiting, headache. The videogame was developed by our team with three levels of difficulty, and approved by pediatric healthcare professionals. The game, oculus head-mounted device and computer will be available in the procedure room and ready for immediate use. The head-mounted device will be adjusted to the head of the child before any procedure and a period of 5 minutes will be allotted prior to pin and/or suture removal in order for the child to get acquainted with the game and immersed in the virtual environment.
15896051|NCT03680612|Drug|Cefepime 1G - 2G / AAI101 0.5G - 0.75G|Experimental drug
15896052|NCT03680612|Drug|cefepime 1 g or cefepime 2 g|cefepime monotherapy
15896053|NCT03680599|Behavioral|Connection to Health for Smokers|Connection to Health for Smokers includes 5 core components supported by online tools: (1) comprehensive electronic patient survey, (2) automated summary report to flag areas of difficulty (3) interactive priority setting, (4) interactive action planning, and (5) electronic text reminders and followup.
15896054|NCT03680599|Behavioral|Enhanced Standard of Care|Participants will complete a survey and receive standard one-on-one smoking cessation according to a usual care protocol delivered by health educators
15896055|NCT03680586|Drug|Radiation Therapy|Undergo ultra low-dose radiation
15896056|NCT03680573|Drug|Control: Lacated Ringers|This site will serve as the control site
15896057|NCT03680573|Drug|Apocynin|This site will be used to inhibit NADPH oxidase and subsequent production of superoxide.
15896058|NCT03680573|Drug|Allopurinol|This site will be use to inhibit xanthine oxidase and subsequent production of superoxide.
15896059|NCT03680573|Drug|BH4|This site will be use to locally supplement BH4.
15896060|NCT03680573|Drug|NG Nitro L Arginine Methyl Ester|L-Name is a NOS inhibitor that is administered to each site to allow for the quantification of NO contribution to vasodilation. The infusion rate will be 2 µl/min
15896061|NCT03680573|Drug|Sodium Nitroprusside|SNP will be perfused through each site to induce maximal vasodilation. The infusion rate will be 2 µl/min
15896062|NCT03680573|Drug|Acetyl-ß-methylcholine chloride|Mch is an acetylcholine analog that causes endothelial dependent vasodilation primarily through stimulation of NO production.
15896063|NCT03680560|Biological|ACTR T Cell Product|Autologous Antibody-Coupled T Cell Receptor (ACTR) T Cell Product (ACTR707 or ACTR087)
15896064|NCT03680560|Drug|Trastuzumab|monoclonal antibody targeting HER2
15896065|NCT03680547|Other|patient with sickle cell disease|assess degree of renal affection in patientswith sickle cell disease attending Assuit university Children hospital by estimating some predictors of glomerular and tubular dysfunction.
15896066|NCT03680534|Procedure|Root canal preparation|Root canals from lower premolars with extraction indicated were prepared previous to being extracted with either the Reciproc Blue, the WaveOne Gold or the XP EndoShaper single-file techniques.
15896067|NCT03680521|Drug|Sitravatinib|Sitravatinib oral capsule administered daily for 6-8 weeks in segments 1 and 2.
15896071|NCT03680482|Other|Intervention ingest a 48 mg of sucralose|Intervention: Subjects with type 2 diabetes who ingest a 48 mg of sucralose. Sucralose is a non-caloric sweetener derived from sucrose and is 600 times more sweet than sucrose. Your allowable daily intake is 15 mg / kg of body weight per day. 85% is not absorbed and is excreted unchanged in the stool; the rest that is absorbed is excreted unchanged by the urine
15896072|NCT03680482|Other|Intervention ingest a 96 mg of stevia|"Intervention: Subjects with type 2 diabetes who ingest a 96 mg of stevia (steviol glycosides). The word stevia refers to the whole plant of Stevia rebaudiana Bertoni (SRB), only some of the components of the stevia leaf are sweet. Steviol glycosides are up to 300 times sweeter than sucrose, do not provide calories and can be used as a substitute for sucrose or as a non-nutritive sweetener alternative. Your allowable daily intake is 4 mg / kg / body weight (expressed as steviol)"
15896073|NCT03680469|Behavioral|standard early rehabilitation|The standard early rehabilitation program is an intervention regularly utilized in the stroke center of National Taiwan University Hospital. Activities performed in the standard early rehabilitation program within 24-72 hours of onset include(1) bed exercises including the joint range of motion exercise, bridge exercise, the straight leg raising exercise, stretching exercises, and facilitation techniques, and (2) functional training in which the patients are instructed to engage in the repetitive and systematic practice of tasks, such as rolling or sitting supported on the bed.
15896074|NCT03680469|Behavioral|adding early out-of-bed mobilization|Early mobilization treatment involving out-of-bed, task-specific activities including rolling and sitting up, sitting unsupported out of bed, and standing within 24-72 hours of onset and accounting for more than two thirds of the treatment time in early rehabilitation .
15896075|NCT03680456|Drug|Ferric carboxymaltose|maximum of 750mg in U.S. is given, maximum of 1000mg in EU
15896076|NCT03680456|Drug|Crystalloid|an equivalent volume dose of Natriumchlorid is administered
15896077|NCT03680443|Other|assembly in THA revision|A single-center continuous series of 62 patients receiving such an assembly in THA revision was assessed retrospectively at a minimum 5 years' follow-up. Failure due to aseptic loosening or instability and implant survival at last follow-up were analyzed.
15896078|NCT03680430|Radiation|Adaptive radiation therapy|Patients will be treated by preoperative or definitive radiotherapy for a limb STS, using an intensity-modulated conformal irradiation (with a static or dynamic technic), over 5 to 7 consecutive weeks. The total dose delivered will be of 50 Gray (preoperative RadioTherapy), or 60 to 70 Gray (exclusive RadioTherapy).
15896079|NCT03680417|Biological|Measles-Rubella (MR) Vaccine|Measles and Rubella Vaccine, live attenuated (Serum Institute of India) Form : Freeze dried Dose : 1 dose 0.5 ml contains not less than 1000 CCID50 of measles virus and 1000 CCID50 of rubella virus.
15896080|NCT03680404|Drug|Control (Phenylephrine)|This intervention is aimed at assessing the vascular responsiveness to phenylephrine, an alpha 1-agonist, in white and black men and women across a series of ascending dose concentrations.
15896081|NCT03680404|Drug|Phenylephrine + Apocynin|This intervention is meant to assess the impact of NADPH oxidase-derived superoxide on vasoconstrictor responses by inhibiting the enzyme NADPH oxidase.
15896082|NCT03680404|Drug|Phenylephrine + Allopurinol|This intervention is meant to assess the impact of xanthine oxidase-derived superoxide on vasoconstrictor responses by inhibiting the enzyme xanthine oxidase.
15896083|NCT03680404|Drug|Phenylephrine + Tempol|This intervention is meant to assess the impact of superoxide on vasoconstrictor responses by scavenging available superoxide.
15896084|NCT03680391|Procedure|Cesarean section|"Both groups cesarean section will be held with the same technique:
~spinal anethesia
~pfennenstiel imcision
~lower segment cesarean section
~suturing uterus in two layers while exterionezed
~gentle manibulation
~no towels in gutters will be used"
15896085|NCT03680378|Drug|Cefepime 2 gram|Combination of cefepime 2 gram with AAI101 1 gram
15896086|NCT03680352|Drug|cefepime/AAI101|Fixed dose combination of cefepime and AAI101
15896087|NCT03680339|Procedure|cesarean section|CS will be done by pfannenstiel incision , transverse lower uterine segment incision ,immediate cord clamping after delivery of baby , closure of uterus by 2 layers , closure of abdomen in layers
15896088|NCT03680339|Drug|Misoprostol|The 100 patients will receive routine ecbolics (for example oxytocin) after delivery of baby plus 400 microgram misoprostol rectally with catheterization and another 400 microgram rectally after closure of abdomen
15896089|NCT03680339|Drug|Oxytocin|10 IU of oxytocin with fetal delivery
15896090|NCT03680326|Device|OCT|only OCT
15896091|NCT03680313|Procedure|Hypertension outpatient treatment|Patients who have been diagnosed with primary hypertension and meet the conditions of the study will receive outpatient treatment
15896092|NCT03680300|Other|Post Facilitation Stretch|"The Post Facilitating Stretch technique is performed as follows:
~The hamstring muscle will be placed between a fully stretched and a fully relaxed state. The patient will be asked to contract the agonist using a maximum degree of effort for 5-10 seconds while the therapist resists the patients force. The patient will then be asked to relax and release the effort, whereas the therapist will apply the rapid stretch to a new barrier and will be held for 10 seconds. Then the patient will relaxes for approximately 20 seconds and the procedure will be repeated between three to five times and five times more. Instead of starting from a new barrier, the muscle will be placed between a fully stretched and a fully relaxed state before every repetition."
15896093|NCT03680300|Other|Post Isometric Relaxation|"The Post Isometric Relaxation technique is performed as follows :
~The hamstring muscle will be taken to a length just short of pain, or to the point where resistance to movement is first noted. A submaximal (10-20%) contraction of the hypertonic muscle will be performed away from the barrier for between 5 and 10 seconds and the therapist applies resistance in the opposite direction. The patient should inhale during this effort. After the isometric contraction the patient will be asked to relax and exhale while doing so. Following this a gentle stretch will be applied to take up the slack till the new barrier. Starting from this new barrier, the procedure is repeated two or three times."
15896094|NCT03680300|Other|Friction Massage|Each patient in group C will receive hot pack along with Tens for 20 mins then the patients will receive frictional massage alone for about one months on daily basis. Friction massage on hamstrings will be given for 20 mins by thrive massager by a therapist.
15896167|NCT03679780|Drug|NG Nitro L Arginine Methyl Ester|L-Name is a NOS inhibitor that is administered to each site to allow for the quantification of NO contribution to vasodilation. The infusion rate will be 2 µl/min
15917233|NCT03518112|Biological|Pegfilgrastim|Given SC
15896095|NCT03680287|Drug|Within-Subject test of blinded study medication|On the day after each sleep condition (Uninterrupted Sleep and Sleep Disruption), participants will undergo multiple injections of study medication or placebo. This is a double-blind within-subject Phase II trial. As such, study medications must remain blinded. Participants may receive a medication from one or more of the following categories: prescription stimulants, prescription benzodiazepines, prescription opioids, prescription cannabinoids, over-the-counter medications, or placebo (saline). This study uses a within-subject design, such that participants serve as participants' own control.
15896096|NCT03680274|Drug|Vitamin C|Intravenous vitamin C administered in bolus doses of 50 mg/kg mixed in a 50-mL solution of either dextrose 5% in water (D5W) or normal saline (0.9% NaCl), during 30 to 60 minutes, every 6 hours for 96 hours (i.e. 200 mg/kg/day and 16 doses in total).
15896097|NCT03680274|Other|Control|Dextrose 5% in water (D5W) or normal saline (0.9% NaCl) in a volume to match the vitamin C.
15896098|NCT03680261|Radiation|chemoradiotherapy|CRT (1 cycle CT: Xelox or SOX, Q21d×1, Followed by RT: 45 Gray (Gy), 5d/week×5 with capecitabine or S1, Followed by 3 cycles CT: Xelox or SOX, Q21d×3) will be applied to radical resected advanced gastric cancer patients with lymph node metastasis and lymphovascular Invasion.
15896099|NCT03680261|Drug|chemotherapy|CT (6 cycles CT: Xelox or SOX, Q21d×3) will be applied to radical resected advanced gastric cancer patients with lymph node metastasis and lymphovascular Invasion.
15896100|NCT03680248|Dietary Supplement|Fat|Subjects will consume dairy cream (150 g of fat) at time 0 hours.
15896101|NCT03680248|Dietary Supplement|Fasting|Subjects will fast throughout the experiment.
15896102|NCT03680248|Dietary Supplement|Fat+Glucose|Subjects will consume dairy cream (150 g of fat) at time 0 hours. At the same time and 2 and 4 hours later they will drink herbal tea containing 50 g of glucose.
15896103|NCT03680248|Dietary Supplement|Glucose|Subjects will drink herbal tea containing 50 g of glucose at times 0, 2 and 4 hours.
15896104|NCT03680248|Dietary Supplement|Fat+Fructose|Subjects will consume dairy cream (150 g of fat) at time 0 hours. At the same time and 2 and 4 hours later they will drink herbal tea containing 50 g of fructose.
15896105|NCT03680248|Dietary Supplement|Fructose|Subjects will drink herbal tea containing 50 g of fructose at times 0, 2 and 4 hours.
15896106|NCT03680235|Other|Informational Intervention|Receive standard information about breastfeeding and pregnancy
15896107|NCT03680235|Other|Informational Intervention|Receive information about breastfeeding and cancer
15896108|NCT03680235|Other|Interview|Participate in focus groups
15896109|NCT03680235|Other|Survey Administration|Ancillary studies
15896110|NCT03680222|Procedure|Reversed Tracking Method|Reversed Tracking Method
15896111|NCT03680209|Other|Simulation|pre-training observation training post training observation
15896112|NCT03680196|Drug|medication Botulinum A injection.|In cerebral palsy patients, Botulinum toxin within the allowable dose of 16 U / kg per body weight will injected into both adductor longus, adductor magnus muscle at 3 U / kg, adductor brevis, and gracilis muscle at a dose of 1 U / kg.
15896113|NCT03680183|Drug|Entecavir 1Mg Oral Tablet|The anti-HBV treatment includes a anti-HBV antibiotics and a drug of protecting liver cells or decrease alanine aminotransferase (ALT) or aspartate transaminase (AST)
15896114|NCT03680170|Behavioral|Working memory updating training|Each training session includes four working memory updating tasks that is performed at the participants home on their computer via internet. Each training session takes about 20 minutes to perform.
15896115|NCT03680170|Behavioral|Placebo training|Each training session includes four short term memory tasks that is performed at the participants home on their computer via internet. Each training session takes about 20 minutes to perform.
15896116|NCT03680144|Procedure|Dynamic Susceptibility Contrast-MRI (DSC-MRI)|Undergo DSC-MRI
15896117|NCT03680144|Procedure|Magnetic Resonance Imaging (MRI)|Undergo diagnostic MRI
15896122|NCT03680118|Device|autogenous rings with GBR and autogenous graft with ti-mesh|"Autogenous Onlay ring block harvested from either mandibular ramus or chin will be placed over the defected site and fixed using titanium screws (1.6mm diameter) and then GBR using autogenous particulate will be placed around and over the blocks and covered with a resorbable bilayer collagen membrane (Bio-Gide®, Geistlich, USA)
~Autogenous bone graft will be placed on the defected site and covered by a titanium mesh which will be fixed by titanium screws.
~Flap advancement will be acquired by releasing the mylohyoid muscle attachment from the lingual flap and periosteal releasing incision for the buccal flap to provide tension free closure.
~The flap will then be copiously irrigated with saline in preparation for closure.
~The flap will then be closed using horizontal mattress and interrupted 4/0 polypropylene sutures."
15896123|NCT03680105|Drug|RJX|RJX is an IV infusion formulation. The appropriate RJX dose is calculated based on mL/kg. The administration dose is prepared by adding the appropriate RJX dose to 0.9% sterile saline such that a constant volume of 100 mL per IV infusion is obtained. Infusion time is 100 mL over 45 minutes (+/- 5 minutes).
15896124|NCT03680105|Drug|Placebo|Matching placebo will be normal saline. To maintain the blind, a sleeve will cover the infusion bag and line such that the appearance will be identical to RJX administration.
15896125|NCT03680092|Drug|Cyclophosphamide|Day 3 and day 4 following transplant. Dosing will be based on patients' actual weight up to 120% of ideal body weight, above which it will be based on adjusted ideal body weight (ideal weight plus 50% of the difference between ideal and actual weight).
15896126|NCT03680092|Drug|abatacept|Abatacept at a dose of 10mg/kg will be administered on days +5, +14 and +28, +56, +84, +112, +140, +168
15896127|NCT03680092|Drug|Methotrexate|standard of care Methotrexate 5 mg/m2 on Days 1, 3, 6 and 11
15896128|NCT03680092|Drug|Tacrolimus|Tacrolimus per institutional guidelines
15896129|NCT03680079|Other|Group education sessions|Peer support and interaction both in-person during group education sessions and online via social media platforms
15896168|NCT03679780|Drug|Sodium Nitroprusside|SNP will be perfused through each site to induce maximal vasodilation. The infusion rate will be 2 µl/min
15896464|NCT03677713|Procedure|No nasal packing.|No nasal packing at the end of the surgery
15896130|NCT03680066|Other|Oral food challenge to foods with traces|"Subjects will undergo an open food challenge to 3 processed foods labeled with may contain traces. The following foods (similar for all patients) will be given in one dose in the size of a regular serving:
~cookies, max 30 g;
~chocolate, max 30 g;
~breakfast cereals, max 50 g.
~Each meal will be administered with a 1 hour observation period in between and at the end."
15896131|NCT03680053|Drug|Duphaston|Women will receive oral duphaston 20mg daily from Day 3 till the day of ovulation trigger.
15896132|NCT03680053|Drug|Cetrorelix|Women will receive antagonist (Cetrorelix 0.25mg) once subcutaneously daily from day 6 of ovarian stimulation till the day of the ovulation trigger.
15896133|NCT03680040|Diagnostic Test|Subjects previously implanted with a RESILIA aortic tissue valve.|Subjects to undergo multi-slice computed tomography and echocardiogram to assess predictors of valve durability in previously implanted Edwards aortic valves with RESILIA tissue.
15896134|NCT03680027|Dietary Supplement|Walnut-enriched Group|All subjects supplemented with 40 g/day of walnuts for 6 weeks.
15896135|NCT03680014|Diagnostic Test|CUSH|Machine learning assisted remote monitoring/ telehealth platform to predict and prevent falls
15896136|NCT03680001|Behavioral|Training in Rating Emotional Connection|Didactic education (video-supported educational module) on emotional connectivity will be offered to the subjects. Subjects will conference with PI to review ratings on modules.
15896137|NCT03679975|Drug|Riluzole Oral Soluble film (ROSF) 50 mg|Enrolled subjects underwent an instrumental evaluation of swallowing safety before and after administration of a single dose of the ROSF formulation containing 50 mg of riluzole.
15896138|NCT03679962|Behavioral|Triple Chronotherapy|"Day 0: One night of total sleep deprivation. The first 24 hours are spent with 1:1 nursing care for provision of comfort measures to stimulate wakefulness and to encourage completion of the intervention.
~Day 1-4: Sleep phase advancement Day 1: Sleep from 6 PM to 1 AM Day 2: Sleep from 8 PM to 3 AM Day 3: Sleep from 10 PM and 5 AM Day 4: Awaken at 5 AM; discharge following light therapy
~On days 1-4 patients will receive bright light therapy at 7am to 7:30am using a 10,000 Verilux light box. At discharge patients will be given a light box, strongly advised to continue the maintenance sleep schedule and bright light therapy at 7am daily for 30 minutes. Patients will be scheduled for follow-up appointments at 1-week, 1-month and 2-month following discharge."
15896139|NCT03679962|Behavioral|Treatment as Usual|Normal inpatient care, including pharmacotherapy, psychotherapy, milieu therapy and social work interventions
15896140|NCT03679949|Drug|Oxycodone|Oxycodone, 2.5 mg
15896141|NCT03679949|Drug|Cannabis (THC:CBD = ~ 1:0)|Cannabis with high THC concentration and negligible CBD concentrations
15896142|NCT03679949|Drug|Cannabis (THC:CBD = ~ 0:1)|Cannabis with high CBD concentration and negligible THC concentrations
15896143|NCT03679949|Drug|Cannabis (THC:CBD = ~ 1:1)|Cannabis with equivalent CBD and THC concentrations
15896144|NCT03679949|Drug|Placebo|Cannabis with negligible amounts of THC and CBD 0.0 mg oxycodone
15896145|NCT03679936|Diagnostic Test|PET/CT dynamic scan|This study is designed to evaluate the patients who are first diagnosed with non-small cell lung cancer (NSCLC)，for 18 F-FDG PET/CT dynamic scanning and primary tumors and/or metastases in biopsy, than find the inner link of the tumor imaging findings, genomics and histopathologic characteristics, discuss diagnostic value of 18 F-FDG PET/CT dynamic imaging in metastatic non-small cell lung cancer (NSCLC). At the same time, evaluating the ability of 18 F-FDG PET/CT dynamic imaging to differentiating multiple primary lung cancer from intrapulmonary metastases.
15896146|NCT03679923|Dietary Supplement|NEM® brand eggshell membrane|Dietary supplement for the support of joint health.
15896147|NCT03679923|Dietary Supplement|Placebo|Placebo
15896148|NCT03679910|Diagnostic Test|CEMIP , CA19-9 ,CEA|CEMIP: Cell migration inducing protein CA19-9: Carbohydrate antigen 19-9 CEA: Carcinoembryonic antigen
15896149|NCT03679910|Diagnostic Test|A) CBC . B) RBG. C)KFT. D) LFT.|A)CBC: Complete blood count. B)RBG: Random blood glucose. C)KFT: Kidney function tests. D)LFT: Liver function tests.
15896150|NCT03679897|Drug|Ropivacaine solution|ultrasound-guided infraclavicular brachial plexus block with 0.375% ropivacaine solution
15896151|NCT03679897|Drug|Levobupivacaine solution|ultrasound-guided infraclavicular brachial plexus block with 0.25% levobupivacaine solution
15896152|NCT03679884|Drug|ACT-541468 10 mg|ACT-541468 10 mg tablets
15896153|NCT03679884|Drug|ACT-541468 25 mg|ACT-541468 25 mg tablets
15896154|NCT03679884|Drug|ACT-541468 50 mg|ACT-541468 50 mg tablets
15896155|NCT03679884|Drug|Placebo|ACT-541468 matching placebo tablets
15896156|NCT03679871|Other|Questionnaire validation|"Participants will fill in the questionnaire Spiritual Resources and Distressplus additional questionnaires required for validation purposes. Three weeks later, a sub-sample will fill in the questionnaire one more time for consistency testing (test-retest)"
15896157|NCT03679858|Other|Platelet function test|Ex vivo platelet aggregation analysis by Multiplate aggregometer
15896158|NCT03679845|Drug|Sarilumab|Sarilumab is an IL-6 monoclonal antibody that has shown to be potentially important in the creation of sclerosis in SSc.
15896159|NCT03679819|Device|HR-TRUS|Medical procedures to be performed in the study consist of subject preparation and prostate imaging. The HR-TRUS exam will be done with a transrectal probe either the day before surgery, or in the OR right before surgery. The exam will be done in the same manner as during a regular transrectal ultrasound exam and no invasive procedures will be associated.
15896160|NCT03679806|Other|Halliwick|The exercise program was progressed by increasing the speed and the range of motion of the movements. Patients were asked not to accelerate the exercise and to focus on their alignment. Mental adjustment, sagittal rotation, transverse rotation, and combined rotation controls, balances in stillness steps of the Halliwick concept were included.
15896161|NCT03679806|Other|Aquatic Plyometric Exercises|The APE programme was progressed by increasing speed and the range of motion of the movements. Patients were carefully informed not to deform the exercise just to emulate the speed. The three phases of each exercise; eccentric (or loading) phase, the amortization phase, and the concentric (or unloading) phase explained thoroughly at the beginning of every exercise.
15896162|NCT03679793|Procedure|Open Release Group|Open surgical release of the A1 pulley is the gold standard of treating symptomatic trigger finger
15896163|NCT03679793|Procedure|Percutaneous Release Group|Percutaneous release is a minimal invasive alternative surgical procedure
15896169|NCT03679780|Drug|Lactated Ringer's|Lactated Ringer will serve as the control site. The infusion rate will be 2 µl/min
15896171|NCT03679754|Biological|Ad-RTS-hIL-12|"2.0 x 10^11 viral particles (vp) per injection
~intratumoral injection of Ad-RTS-hIL-12"
15896172|NCT03679754|Drug|veledimex|"20mg/day
~15 oral daily doses of veledimex"
15896173|NCT03679741|Device|CONTROL Lens|Acuvue OASYS
15896174|NCT03679741|Device|TEST Lens|senofilcon A
15896175|NCT03679728|Behavioral|First trimester|Analysis of sensorimotor outcomes
15896176|NCT03679728|Behavioral|Second trimester|Analysis of sensorimotor outcomes
15896177|NCT03679715|Other|participatory art-based activity|"The intervention is a participatory art-based activity which consists in making art in group, involving the participants directly in the creative process, allowing them to become co-authors of the work.
~In Montreal, Canada, participants will meet once per week for a 2h workshop from 2.00 PM to 4.00 PM at the MMFA in a dedicated room during a three month-period defining a session. Two successive sessions will be setup; a winter and a spring sessions. Each session will be composed of 12 consecutive workshops.
~In Tokyo, Japan, participants will meet once per week for a 2h workshop at the Tokyo Fuji Museum in a dedicated room during a three month-period defining a session. The session will be composed of 12 consecutive workshops."
15896178|NCT03679702|Device|Viveve System|Radiofrequency device utilized in general surgical procedures for electrocoagulation and hemostasis.
15896179|NCT03679689|Dietary Supplement|artificially sweetened beverages|artificially sweetened beverages restriction
15896180|NCT03679676|Drug|Omalizumab|Omalizumab is injected every 2 to 4 weeks
15896181|NCT03679676|Drug|Dupilumab|"Dupilumab is injected every 2 weeks
~combination, or placebo."
15896182|NCT03679676|Other|Placebo|Placebo is injected every 2 to 4 weeks
15896183|NCT03679663|Device|Ultrasound|Use of ultrasound to identify pre-puncture site
15896184|NCT03679650|Drug|decitabine|Decitabine is thought to act as an anti-metabolite. It seems to work by having a toxic effect on the abnormal bone marrow cells.
15896185|NCT03679650|Biological|DC/AML fusion cells|An investigational agent that tries to help the immune system to recognize and fight against cancer cells
15896186|NCT03679637|Behavioral|Tablet-based aphasia therapy|patients will independently practice with a speech app during hospitalisation
15896187|NCT03679624|Drug|Ibrutinib|Ibrutinib, 420mg orally, once daily
15896188|NCT03679624|Drug|Daratumumab|Daratumumab, 16 mg/kg intravenously, weekly for 8 weeks, bi weekly for 16 weeks, then monthly for up to 19 months.
15896191|NCT03679598|Drug|Alvelestat (MPH966)|Alvelestat was developed as treatment for lung diseases like Chronic Obstructive Pulmonary Disease. Alevelestat works by blocking certain proteins in the body that are responsible for inflammation and damage to the lungs that can lead to COPD symptoms.
15896192|NCT03679598|Other|Placebo|Placebo is a pill or tablet that does not contain any study drug.
15896193|NCT03679585|Other|Internet-Based Intervention|Undergo Talking Pictures social media intervention
15896194|NCT03679585|Other|Quality-of-Life Assessment|Ancillary studies
15896195|NCT03679585|Other|Questionnaire Administration|Ancillary studies
15896196|NCT03679572|Procedure|Robot assisted partial nephrectomy super-selective clamping|The device used to performe the surgery is a Da Vinci robot. After injection of infracyanine, the super-selective clamping is possible. The surgery is performed using a specific clamping of the tumor arteries. Super-selective ischemia is checked using near infrared fluorescence.
15896197|NCT03679572|Procedure|Robot assisted partial nephrectomy with renal artery clamping|Partial nephrectomy is performed with the conventional method in wich a renal artery clamping is done.
15896198|NCT03679559|Other|Best Practice|Continue usual physical activity
15896199|NCT03679559|Behavioral|Exercise Intervention (home walking program and resistance training)|Complete home-based walking program and resistance training
15896200|NCT03679559|Behavioral|Exercise Intervention (home-based Zumba program and resistance training)|Complete home-based Zumba program and resistance training
15896201|NCT03679559|Behavioral|Exercise Intervention (HIIT program and resistance training)|Complete HIIT program and resistance training
15896202|NCT03679559|Other|Informational Intervention|Watch video
15896203|NCT03679559|Other|Laboratory Biomarker Analysis|Correlative studies
15896204|NCT03679559|Device|Monitoring Device|Wear Fitbit
15896205|NCT03679559|Other|Quality-of-Life Assessment|Ancillary studies
15896206|NCT03679559|Other|Questionnaire Administration|Ancillary studies
15896207|NCT03679546|Drug|Infliximab|Infliximab : The treatment is infused at a dose of 5 mg/kg at week 0, 2 and 6 and then every 8 weeks.
15896208|NCT03679546|Drug|Vedolizumab Injection|Vedolizumab : The treatment is infused at a dose of 300 mg at week 0, 2 and 6 and then every 8 weeks.
15896209|NCT03679533|Dietary Supplement|Freeze-Dried Cranberry Powder|Freeze-dried cranberry powder (or matched placebo), approximating 500mg active flavonoids per day, taken twice daily for 12 weeks.
15896210|NCT03679533|Dietary Supplement|Placebo|Placebo food powder matched for taste, colour, energy and macronutrient content to the active cranberry powder.
15896211|NCT03679520|Other|New programme|"Time for topics related to the time after birth and in reversed chronological order to give an early and joint focus on parenthood for both parents. Involving new parents to share their experiences of early parenthood with expectant parents. Introducing and using evidence-based websites in the sessions A breastfeeding preparation that gives tools to meet common challenges in the initial phase of breastfeeding. Based on principles for adult learning.
~Sessions
~Introduction, life-change of becoming a parent and co-parenting
~Early parenthood
~Breastfeeding, caring for the baby and early parenthood
~and 5 Labour, birth and postnatal care"
15896212|NCT03679520|Other|Regular programme|"Antenatal parental preparation as usual. As no guidelines exist the number of sessions may vary between 2 and 3 sessions and smaller variations in content may also occur.
~Sessions
~(or 1 and 2) Labour, birth and postnatal care
~or 3 Breastfeeding, caring for the baby and early parenthood"
15896213|NCT03679507|Procedure|Low Intensity Ultrasound Therapy|Subjects suffering from chronic pain due to osteoarthritis of the knee will be recruited for this study, and randomly assigned to two groups. One-half of these Subjects (Group A) will receive ultrasound therapy as detailed below on the affected joint; the other half (Group B) is a placebo group.
15896214|NCT03679507|Other|Enhancing CBD oil penetration into joints by sonophresis|High CBD oil will be applied to the affected knee of one-half of the recruited subjects.
15896215|NCT03679494|Other|Shared decision making support tool|Health education materials containing treatments and questions about patient values to help patients make the most appropriate decisions
15896216|NCT03679481|Drug|Tranexamic acid (TXA)|Following induction of anesthesia and prior to surgical incision, patients will receive 1 gram of intravenous TXA mixed in 100cc of normal saline.
15896217|NCT03679481|Drug|Normal saline|Following induction of anesthesia and prior to surgical incision, patients will receive 100cc of normal saline.
15896218|NCT03679468|Other|Cognitive Rehabilitation|"RehaCom software
~Information processing speed and attention modules"
15896219|NCT03679468|Other|Sham Exercise|Sets of balance and stretching exercises
15896220|NCT03679468|Other|Sham Cognitive Rehabilitation|"Kompozer software
~24 session module consisting of basic internet searches"
15896221|NCT03679468|Other|Aerobic Exercise|"Recumbent NuStep Bike
~Aerobic cycling"
15896222|NCT03679455|Drug|Obinutuzumab 25 MG/ML|Study treatment, obinutuzumab is a Type II humanized anti-CD20 monoclonal antibody of the IgG1 subclass derived by humanization of the parental B-Ly1 mouse antibody and produced in the Chinese Hamster Ovary cell line by recombinant DNA technology. The Study Treatment, obinutuzumab is a liquid concentrate for infusion. Obinutuzumab vials are type 1 glass vials with a butyl rubber stopper. Obinutuzumab is provided as a single 1000 mg dose liquid concentrate with a strength of 25 mg/mL. It is supplied in 50 mL glass vials containing 40 mL of the 25 mg/mL liquid concentrate.
15896223|NCT03679442|Drug|N-acetylcysteine|Non-randomized exposure to N-acetylcysteine (NAC) of healthy individuals corresponding to the clinical treatment guidelines for paracetamol-overdosed patients
15896224|NCT03679429|Device|NBI Function|In the intervention arm polyps will be optically characterized using the NBI function. The WASP (Workgroup serrAted polypS and Polyposis) classification will be used in order to determine the optical diagnosis.
15896225|NCT03679403|Other|Psychiatric diagnosis|Kiddie Schedule for Affective Disorders & Schizophrenia (K-SADS) for DSM-5
15896226|NCT03679390|Drug|Ketamine|With the Ketamine group, we add ketamine 0.5mg/kg for anesthesia.
15896227|NCT03679377|Device|Mandibular slotplate|Mandibular slotplates are placed during the osteosynthesis phase of the BSSO surgery. After testing of the plates they are removed and the osteotomy is fixated with three bicortical screws.
15896228|NCT03679338|Device|Ablation Therapy|Ablation Therapy With Bipolar Radio frequency
15896229|NCT03679325|Dietary Supplement|vitamine D|a dose once a week
15896230|NCT03679325|Other|whole body vibration (WBV)|03 months of WBV training three times per week
15896231|NCT03679312|Drug|Nitric Oxide|Inhaled nitric oxide, which consists of breathing medical grade air (21% O2) with 40 parts per million of nitric oxide.
15896232|NCT03679312|Drug|Placebo|Inhaled placebo, which consists of breathing medical grade air (21% O2).
15896233|NCT03679299|Other|Observational - No intervention|See outcomes
15896234|NCT03679286|Device|PCM and ROTEM|Test of blood sample by both PCM and ROTEM
15896235|NCT03679273|Dietary Supplement|Abound|Study Group will take the supplementation drink containing 79 kcal, 7 g L-arginine, 7 g L-glutamine and 1.5 g calcium β-hydroxy-β-methylbutyrate (Abound; Abbott Nutrition, Columbus, OH, USA). The subjects will be instructed to drink the entire packet dissolved in 250 ml of water twice per day for 21 days.
15896236|NCT03679260|Other|Carbohydrate restricted diet|20 grams total carbs/day
15896237|NCT03679260|Other|Non-restricted diet|Subject follows normal diet
15896238|NCT03679260|Other|Phone counseling with dietitian|Weekly calls with dietitian
15896239|NCT03679247|Other|Intervention|"The intervention will be a clinical decision support (CDS) system that contains three main features: 1) methods to synthesize electronic health record (EHR) data in order to identify under-diagnosed chronic conditions (synthesize existing medical data to increase recognition of CKD and uncontrolled HTN in CKD patients and deliver management recommendations based on this evidence), 2) improve the design and content of the CDS using human factors methods, specifically usability testing, and 3) the use of two behavioral nudges (pre-checked default orders and an email to obtain commitment from PCPs to obtain their commitment to follow the CDS recommendations)."
15896240|NCT03679247|Other|Control|Usual Care, PCP will receive an email with general information about CKD guidelines
15896241|NCT03679234|Other|Routine infant formula|Routine infant formula with probiotic
15896242|NCT03679221|Other|Data collection|telephone interview questionnaire, in-home face-to-face interview, and data from the Collection Site
15896243|NCT03679208|Device|Investigational device coded KIO014|Innovative chitosan-based biomaterial intended for intraarticular injection.
15896244|NCT03679208|Device|Durolane(r) as control device|Crosslinked hyaluronic acid-based biomaterial intended for intraarticular injection.
15896245|NCT03679195|Dietary Supplement|NO Ultra|6-week supplementation period with 764 mg/day of cranberry and grape seed extracts (containing polyphenols) and 2 g/day of L-citrulline Participants will have to take daily 2 NO Ultra capsules (containing 382 mg cranberry and grape seed extracts / 1 g L-citrulline) between breakfast and lunch and 2 other NO Ultra capsules between lunch and dinner.
15896246|NCT03679195|Dietary Supplement|Placebo|"6-week supplementation period with placebo capsules (the active ingredients will be replaced by cellulose)
~Participants will have to take 2 capsules of cellulose between breakfast and lunch and 2 capsules between lunch and dinner to match the number of capsules ingested daily by the NO Ultra group."
15896247|NCT03679182|Drug|Olanzapine|Olanzapine 5 mg Tab at 0, 12, 24, and 36 hours
15896248|NCT03679169|Procedure|pancreatosplenectomy|standard or radical anterograde modularpancreatosplenectomy
15896249|NCT03679156|Device|OCT|Patients were recruited, visual acuity and optical coherence tomography Pictures were taken
15896250|NCT03679143|Drug|ZSP1273 100 mg|ZSP1273 tablet administered orally once daily under fasted condition
15896251|NCT03679143|Drug|Placebo 100 mg|Participants will receive placebo matching to ZSP1273 orally once daily in the fasting state.
15917234|NCT03518112|Biological|Rituximab|Given IV
15896252|NCT03679143|Drug|ZSP1273 200 mg|ZSP1273 tablets administered orally once daily under fasted condition
15896253|NCT03679143|Drug|Placebo 200 mg|Participants will receive placebo matching to ZSP1273 orally once daily under fasted condition
15896254|NCT03679143|Drug|ZSP1273 400 mg|ZSP1273 tablets administered orally once daily in the fasting state
15896255|NCT03679143|Drug|Placebo 400 mg|Participants will receive placebo matching to ZSP1273 orally once daily in the fasting state
15896256|NCT03679143|Drug|ZSP1273 600 mg|ZSP1273 tablets administered orally once daily under fasted condition
15896257|NCT03679143|Drug|Placebo 600 mg|Participants will receive placebo matching to ZSP1273 orally once daily under fasted condition
15896258|NCT03679143|Drug|ZSP1273 900 mg|ZSP1273 tablets administered orally once daily in the fasting state
15896259|NCT03679143|Drug|Placebo 900 mg|Participants will receive placebo matching to ZSP1273 orally once daily under fasted condition
15896260|NCT03679143|Drug|ZSP1273 1200 mg|ZSP1273 tablets administered orally once daily in the fasting state
15896261|NCT03679143|Drug|Placebo 1200 mg|Participants will receive placebo matching to ZSP1273 orally once daily in the fasting state
15896262|NCT03679143|Drug|ZSP1273|ZSP1273 tablets administered orally once daily under fasted or fed condition
15896263|NCT03679143|Drug|Placebo|Participants will receive placebo matching to ZSP1273 orally once daily under fasted or fed condition
15896264|NCT03679143|Drug|ZSP1273 Low Dose|ZSP1273 tablets administered orally once daily under fasted or fed condition for 5 Days.
15896265|NCT03679143|Drug|Placebo|Participants will receive placebo matching to ZSP1273 orally once daily under fasted or fed condition for 5 Days.
15896266|NCT03679143|Drug|ZSP1273 Median Dose|ZSP1273 tablets administered orally twice daily for 4 Days and once daily on Day 5 under fasted or fed condition.
15896267|NCT03679143|Drug|Placebo|Participants will receive placebo matching to ZSP1273 orally twice daily for 4 Days and once daily on Day 5 under fasted or fed condition.
15896268|NCT03679143|Drug|ZSP1273 High Dose|ZSP1273 tablets administered orally twice daily for 4 Days and once daily on Day 5 under fasted or fed condition.
15896269|NCT03679143|Drug|Placebo|Participants will receive placebo matching to ZSP1273 orally twice daily for 4 Days and once daily on Day 5 under fasted or fed condition.
15896270|NCT03679130|Behavioral|Structured supervised exercise training|EXE contains three weekly one-hour exercise sessions at moderate intensity, more specifically one water exercise session and two land exercise sessions. The training will be supervised, held in teams, and both water and land exercise sessions will consist of a combination of aerobic and resistance training.
15896271|NCT03679130|Behavioral|Motivational counseling supported by health technology|MOT contains four individual and three group counseling sessions taking place from randomization until GA week 33+6 and aim to motivate the participants to increase their physical activity level at moderate intensity. During individual sessions, feedback on physical activity performance will be provided based on activity data acquired from the activity tracker and further, MOT-participants will receive weekly SMS-reminders about physical activity.
15896272|NCT03679117|Behavioral|Mindfulness Training|Phone-delivered mindfulness training. 8 weeks of 30 minute phone sessions with an instructor, plus 15 minutes of self-guided practice.
15896273|NCT03679104|Procedure|Closure of mucosotomy using endoscopic clips|Gastric per-oral endoscopic pyloromyotomy procedure requires the incision in the mucosa and submucosa. The closure of this incision at the end of the procedure will be done using endoscopic clips. These are used in endoscopy to mechanically close two mucosal surfaces without the need for surgery and suturing. In this study, the following endoclips may be used: Resolution 360™ Clip (Boston Scientific), QuickClip Pro™(Olympus) or Instinct™ Endoscopic Hemoclip (Cook Medical).
15896274|NCT03679104|Procedure|Closure of mucosotomy using OverStitch™ suturing device|Gastric per-oral endoscopic pyloromyotomy procedure requires the incision in the mucosa and submucosa. The closure of this incision at the end of the procedure will be done by OverStitch™ (Apollo Endosurgery Inc., Austin, Texas, USA), which is a suturing device that enables advanced endoscopic surgery by allowing physicians to place full-thickness sutures through a flexible endoscope.
15896275|NCT03679091|Drug|low-dose ticagrelor|low-dose ticagrelor (60.0 mg once daily) for 7 days,followed by a 2-week washout period then a 7 days crossover phase of clopidogrel (75mg once daily).
15896276|NCT03679091|Drug|Clopidogrel|clopidogrel (75mg once daily) for 7 days,followed by a 2-week washout period then a 7 days crossover phase of low-dose ticagrelor (60.0 mg once daily).
15896277|NCT03679078|Dietary Supplement|IDDSI nutritional supplement drink|ready-to-use nutritional supplement drink to be taken daily for 28 days
15896278|NCT03679065|Drug|Paracetamol|Each patient received 1g paracetamol tablet orally with sips of water and 100 ml 0.9% sodium chloride (normal saline [NS]) (IVI) over 15 minutes as a placebo for Dex solution 2 hours preoperatively.
15896279|NCT03679065|Drug|Dexamethasone|Each patient received a placebo tablet identical to paracetamol tablet orally with sips of water and Dex 8 mg ampoule diluted in 100 ml 0.9% NS IVI over 15 minutes, 2 hours preoperatively.
15896280|NCT03679065|Drug|Placebo|Each patient received a placebo tablet identical to paracetamol tablet orally with sips of water and 100 ml 0.9% NS IVI over 15 minutes as a placebo for Dex solution 2 hours preoperatively.
15896281|NCT03679052|Drug|Mirtazapine|Each patient received 30 mg mirtazapine tablet and a placebo tablet for clonidine orally with sips of water 2 h preoperatively.
15896282|NCT03679052|Drug|Clonidine|Each patient received 150 µg clonidine tablet and a placebo tablet for mirtazapine orally with sips of water 2 h preoperatively.
15896283|NCT03679052|Drug|Placebo|Each patient received two placebo tablets for mirtazapine and clonidine orally with sips of water 2 h preoperatively.
15896284|NCT03679026|Other|Summarize of participants' characteristics using means and standard deviations or frequencies and percentages|Participants' baseline characteristics will be summarized using means and standard deviations or frequencies and percentages, as appropriate.
15896285|NCT03679013|Drug|Oral Gabapentin and Intravenous Acetaminophen (IV APAP)|Scheduled multimodal pain regimen consisting of oral Gabapentin paired with intravenous Acetaminophen following cardiopulmonary bypass surgery.
15896286|NCT03679013|Drug|Opiate based pain regimen.|Standard of care opite based pain regimen.
15896287|NCT03678987|Diagnostic Test|P-MPA concentration|We will calculate AUC_0-12 of MPA based on 4 measurements of P-MPA
15917235|NCT03518112|Drug|Vincristine Sulfate|Given IV
15896288|NCT03678987|Drug|mycophenolic acid|Patient will ingest mycophenolic acid as prescribed by their physician under the surveillance of an investigator.
15896289|NCT03678974|Behavioral|Exercise Prescription|The CardioCoach Vo2Max app allows the physician to upload an individual's Vo2 Max and resting metabolic rate results to the app which will allow each subject to view those results in the context of workout zones, goals, and energy balance. The app shows time spent aerobic versus anaerobic, and the actual number of calories burned during a workout and post-workout. It will also show what fuel source (Fats vs Carbs) are being used in real time during your workouts. Subjects can be guided through their workouts utilizing voice coaching to keep you in your customized zones. Additionally, the app accommodates a quick add of calories directly to the app to track calories consumed vs calories burned.
15896290|NCT03678961|Behavioral|external rotation of leg|external rotation of leg by 45 degrees
15896291|NCT03678961|Behavioral|hip flexion and knee flexion|hip flexion by 15/45 degrees and knee flexion by 15/45 degrees
15896292|NCT03678948|Device|Radiofrequency-Based Debridement|In this process, radiofrequency energy is used to excite the water molecules in a conductive medium, such as an electrolyte (saline) solution, to generate excited radicals within precisely focused plasma. The energized particles in the plasma have sufficient energy to break molecular bonds (16-18), excising or dissolving (i.e. ablating) soft tissue at relatively low temperatures (typically 40ºC to 70ºC).
15896293|NCT03678948|Device|Mechanical Debridement|Arthroscopic chondroplasty used to remove loose and damaged cartilage which minimizes synovial irritation and mechanical impingement
15896294|NCT03678935|Other|Low FODMAP diet|The intervention group follows the low FODMAP diet for 4 weeks.
15896295|NCT03678909|Procedure|Norwood Palliation / DKS / Damus-Kaye-Stansel procedure|Norwood Palliation / DKS / Damus-Kaye-Stansel procedure
15896296|NCT03678896|Behavioral|CrewD Program|The CrewD Program - Creative reading and writing in Diabetes Program - is a Diabetes self-management education and support program to help people with Diabetes coping with the disease.
15896297|NCT03678896|Behavioral|Classical structured education|The Classical educational approach consists in an educational method based on the presentation of relevant theoretical information to help people with Diabetes coping with the disease.
15896298|NCT03678883|Drug|9-ING-41|Starting dose of-9-ING-41 will be administered on Day 1 and 4 each week of a 21-day cycle. 9-ING-41 will be administered intravenously over 60 minutes.
15896299|NCT03678883|Drug|Gemcitabine - 21 day cycle|Gemcitabine 1250 mg/m2 as a 30-minute intravenous infusion on Days 1 and 8 of a 21-day cycle
15896300|NCT03678883|Drug|Doxorubicin.|Doxorubicin 75 mg/m2, intravenous bolus on Day 1 of a 21-day cycle up to a maximum lifetime dose of 550 mg/m2.
15896301|NCT03678883|Drug|Lomustine|Lomustine 30 mg/m² orally as a single dose, weekly for twelve weeks.
15896302|NCT03678883|Drug|Carboplatin.|Carboplatin AUC 6 IV over 1 hour on Day 1 of a 21-day cycle.
15896303|NCT03678883|Drug|Nab paclitaxel.|Nab-paclitaxel 125 mg/m2 intravenously on Days 1, 8 and 15 of a 28-day cycle
15896304|NCT03678883|Drug|Paclitaxel.|Paclitaxel 175 mg/m2 intravenously over 3 hours on Day 1 of a 21-day cycle.
15896305|NCT03678883|Drug|Gemcitabine - 28 day cycle|Gemcitabine 1000 mg/m2 intravenously over 30-minutes on Days 1, 8 and 15 of a 28-day cycle
15896306|NCT03678883|Drug|Irinotecan|Irinotecan 350 mg/m2 intravenously over 90-minutes on Day 1 of a 21-day cycle
15896307|NCT03678870|Other|Opioid Education Handout|a single page handout with information about how to use medications for pain after discharge.
15896308|NCT03678857|Dietary Supplement|Creatine|"Participants will resistance train their left arm and left leg one day and their right arm and right leg the next day. Participants will supplement with creatine BEFORE one of the training days (randomized to either left or right side) and on the opposite training day (opposite side of the body to the previous training day) supplement with creatine AFTER training. Having the same person in both conditions will control for genetics, habitual diet, other daily activities, and so on, that may have confounded previous research. Muscle mass and strength changes will be measured in each limb prior to and following 8 weeks of training to determine whether creatine timing influenced muscle growth.
~Research Question: To determine whether creatine supplementation timing (i.e., before versus after training) effects 8 weeks of resistance training adaptations (i.e., muscle growth and strength changes)."
15896309|NCT03678844|Behavioral|Taekwondo practice|The Taekwondo intervention program consisted of the technical skill development aspect (e.g., blocking, punching and kicking) of the sport and poomse (forms) for 30-min.
15896310|NCT03678844|Other|CONTROL|The participants of the control group engaged in physical activities, including athletics, handball and gymnastic, during two sessions of physical education per week at school.
15896311|NCT03678831|Procedure|tissue|Adipocyte isolation from distal femoral epiphysis and subcutaneous adipose tissue at the surgery site; classical piece removal during prosthetic replacement of the knee
15896312|NCT03678818|Other|Medium Supplemented with Latrunculin A|A medium with in-house supplementation of Latrunculin A to decrease oocyte degeneration after ICSI and improve the survival rate
15896313|NCT03678805|Procedure|Corticotomy|Perforations in the areas close to the impacted canines will be performed in order to accelerate tooth movement.
15896314|NCT03678805|Procedure|Traditional withdrawal techniques|The impacted canines will be withdrawn using elastic modules.
15896315|NCT03678792|Drug|Buprenorphine/naloxone|Participants in this group will be tapered on buprenorphine-naloxone regimen, 2mg/day
15896316|NCT03678792|Drug|Morphine|Participants in this group will be tapered on an oral morphine regimen, 30-60mg/day
15896317|NCT03678792|Drug|Tramadol|Participants in this group will be tapered on an oral morphine regimen, 50-100mg/day
15896318|NCT03678779|Behavioral|Incentive|$5 grocery gift card
15896319|NCT03678779|Behavioral|Education|Video-based brief nutrition education
15896320|NCT03678779|Behavioral|Combined|Both Incentive and Education interventions received
15896321|NCT03678766|Behavioral|Regulation of Cues (ROC)|Participants are provided information about basic learning theory and how physiological responses to food cues develop and can be managed. Lack of sensitivity to appetite and satiety cues and increased sensitivity to food cues will be discussed. Coping skills are presented to assist in mastery and toleration of food cue sensitivity. Participants will complete experiential learning exercises with food, and taught to monitor their hunger, satiety, and cravings. The physical activity program will focus on increasing both lifestyle activity and structured exercise programs.
15896322|NCT03678766|Behavioral|Cognitive Behavior Therapy (CBT)|"Participants are taught to identify problems in eating, thinking, and mood patterns that served to trigger binge episodes through self-monitoring and to gradually develop alternative patterns aimed at facilitating healthy, binge-free eating patterns. Participants are taught to eat a healthy variety of foods and reducing the avoidance of forbidden foods that are typically consumed during a binge."
15896323|NCT03678753|Drug|Cenobamate|12.5 mg tablet, 25 mg tablet, 50 mg tablet, 100 mg tablets, 150 mg tablets, 200 mg tablets
15896324|NCT03678753|Drug|Placebo|Matching Placebo
15896325|NCT03678740|Other|Odyssey 2 Survey|Odyssey2 will retain the strengths (simplicity, brevity, confidentiality, and data quality assurance measures) which made Odyssey1 successful. While Odyssey2 adds some refinements based on experience learned from Odyssey1, the basic questions are changed as little as possible to maximize comparability, and the additions are limited. Odyssey1 consisted of between 16 and 23 questions, depending on skip patterns, and took an estimated 15 minutes to complete. Odyssey2 consists of between 23 and 33 questions, depending on skip patterns and we estimate that it will take approximately 20 minutes to complete.
15896326|NCT03678714|Behavioral|Exercise Intervention|2 sessions of supervised exercise training each week for 8 consecutive weeks and 3 sessions of supervised exercise training each week for the final 4 consecutive weeks, at 57-74% heart-rate max. Each session will last approximately 60 minutes.
15896327|NCT03678714|Behavioral|Lifestyle Physical Activity|Advice and information on how to increase physical activity will be provided. Participants will be asked to monitor and track their daily physical activity using a smart-phone fitness application. The research team will gain permission to access their recorded activity.
15896328|NCT03678701|Dietary Supplement|Pre-meal 100% whey protein intake|Participants in the protein group will be provided 100% whey protein powder and will be advised to drink 30g of protein dissolved in 237ml (8oz) of water, one hour before lunch and dinner.
15896329|NCT03678688|Drug|10 mg OPC-167832|Once daily oral dose of 10 mg OPC-167832 from Day 1 through Day 14.
15896330|NCT03678688|Drug|30 mg OPC-167832|Once daily oral dose of 30 mg OPC-167832 from Day 1 through Day 14.
15896331|NCT03678688|Drug|90 mg OPC-167832|Once daily oral dose of 90 mg OPC-167832 from Day 1 through Day 14.
15896332|NCT03678688|Drug|3 mg OPC-167832|Once daily oral dose of 3 mg OPC-167832 from Day 1 through Day 14.
15896333|NCT03678688|Drug|RHEZ|"RHEZ will be used in both Stage 1 and Stage 2. Each tablet contains 150 mg rifampicin, 75 mg isoniazid, 400 mg pyrazinamide, and 275 mg ethambutol. Participants will receive a single-dose from Day 1 through Day 20. The total number of tablets per day will be based on the pretreatment body weight:
~Participants weighing 30 to 37 kg will receive 2 tablets per day
~Participants weighing 38 to 54 kg will receive 3 tablets per day
~Participants weighing 55 to 70 kg will receive 4 tablets per day
~Participants weighing > 70 kg will receive 5 tablets per day"
15896334|NCT03678688|Drug|30 mg OPC-167832 plus 300 mg delamanid|Once daily oral dose of 30 mg OPC-167832 plus 300 mg delamanid from Day 1 through Day 14.
15896335|NCT03678688|Drug|30 mg OPC-167832 plus 400 mg Bedaquiline (BDQ)|Once daily oral dose of 30 mg OPC-167832 plus 400 mg BDQ from Day 1 through Day 14. Subjects will receive a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. The dose of BDQ will be 400 mg QD for Days 3 to 14.
15896336|NCT03678688|Drug|30 mg OPC-167832 plus 300 mg delamanid plus 400 mg Bedaquiline (BDQ)|Once daily oral dose of 30 mg OPC-167832 plus 300 mg delamanid plus 400 mg BDQ from Day 1 through Day 14. Subjects will receive a loading dose of 700 mg BDQ on Day 1 and 500 mg on Day 2. The dose of BDQ will be 400 mg QD for Days 3 to 14.
15896337|NCT03678675|Drug|Ketorolac|The intervention is a protocol of scheduled IV Ketorolac administered postoperatively.
15896338|NCT03678662|Other|Hypoalgesia expectation|"Before and after the squat exercise, assessment of how you experience pressure pain with the 2 devices you have just become acquainted with will be repeated. While doing the squat exercise you will be asked to indicate pain in the thigh muscles.
~What we currently know about the effect of exercise on the experience of pressure pain is that after eg. cycling or walking, more pressure can be applied before the pressure starts to hurt and more pressure is required before you can't withstand anymore.
~Whether this applies to a squat exercise, as the one you are about to perform, has not yet been investigated, but we expect that the same applies here, namely, that more pressure is required before you feel the pressure begins to hurt you and you will be able to endure a greater pressure.
~Supported by visual information."
15896339|NCT03678662|Other|Hyperalgesia expectation|"Before and after the squat exercise, assessment of how you experience pressure pain with the 2 devices you have just become acquainted with will be repeated. While doing the squat exercise you will be asked to indicate pain in the thigh muscles.
~What we currently know is that exercise can cause muscle pain, both during and after training. You may have experienced muscle soreness yourself in relation to training? We expect that the same will apply here. Namely, after performing this squat exercise, which will likely hurt your thigh muscles while doing it, you will experience that the pressure applied afterwards, with the two devices you have just become acquainted with, should be less before it starts to hurt and that you can endure less pressure.
~Supported by visual information."
15896340|NCT03678662|Other|Neutral|"Soon you are going to do a training exercise in a squat position up against the wall for 3 min. Following the squat exercise, we will repeat the measurement of how you experience pressure pain with the 2 devices you have just become acquainted with. While doing the squat exercise you will be asked to indicate pain in the thigh muscles."
15896341|NCT03678649|Drug|Capecitabine|1000-1250 mg/m2 orally twice daily for 14 days followed by a 1-week rest period, given as 3- week cycles for a total of 6 cycles .
15896342|NCT03678636|Device|Silver antimicrobial dressing|Silver dressing suitable for exudate level
15896343|NCT03678636|Device|Standard care|Usual care for wound type and condition
15896344|NCT03678610|Other|Doing ICSI I a medium supplemented with Ionomycin and Latrunculin A|Ionomycin and Latrunculin A would activate oocyte during ICSI along with cytoskeleton stabilization for a favourable outcomes
15896345|NCT03678597|Other|Medium Supplemented with Latrunculin B|A medium with in-house supplementation of Latrunculin B to decrease oocyte degeneration after ICSI and improve the survival rate
15896346|NCT03678584|Other|Medium Supplemented with Chaetoglobosin A|A medium with in-house supplementation of Chaetoglobosin A to decrease oocyte degeneration after ICSI and improve the survival rate
15896347|NCT03678571|Other|Latrunculin A supplemented vitrification medium|Vitrification of human oocyte in medium supplemented with Latrunculin A
15896348|NCT03678558|Other|Cytochalasin B supplemented vitrification medium|Vitrification of human oocyte in medium supplemented with Cytochalasin B
15896352|NCT03678532|Drug|Midazolam|
15896353|NCT03678519|Diagnostic Test|Pulmonary function test|Pulmonary Function tests using Spirometry. It will show following indices of ventilatory functions: Forced vital capacity (FVC), Forced expiratory volume in the 1st second (FEV1) and Forced expiratory volume in the 1st second as a percentage of the Forced vital capacity (FEV1/FVC %).
15896354|NCT03678506|Drug|Apixaban|Apixaban 2.5 mg x 2 will be administered to patients with positive D-dimer results
15896355|NCT03678493|Biological|Fecal Microbiota Transplant (FMT)|Oral Capsule
15896356|NCT03678493|Other|Placebo|Oral Capsule
15896357|NCT03678480|Drug|HTD1801|HTD1801 capsules, 250mg
15896358|NCT03678480|Drug|Ursodeoxycholic Acid|UDCA capsules, 125mg
15896359|NCT03678467|Combination Product|EB-CMF|Autologous, anatomically shaped bone graft
15896360|NCT03678441|Behavioral|BrainCheck Cognitive Assessment|Receive BrainCheck cognitive assessment
15896361|NCT03678441|Procedure|Cognitive Assessment|Receive pen and paper cognitive assessment
15896362|NCT03678428|Drug|Irinotecan|Irinotecan 150 mg/m2 IV over 90 minutes on Day 1 and 15.
15896363|NCT03678428|Drug|Oxaliplatin HAI|Oxaliplatin 85 mg/m2 over 3 hours will be administered through the HAI pump on day 1. Oxaliplatin 85 mg/m2 IV over 3 hours on day 15.
15896364|NCT03678428|Drug|Floxuridine|0.12 mg/kg/day floxuridine (FUDR) and 25 mg dexamethasone in normal saline to a total volume of 300 ml will be administered through the HAI pump.
15896365|NCT03678428|Drug|Leucovorin|Leucovorin 200mg/m2 IV on Day 1 and 15.
15896366|NCT03678428|Drug|5-FU|5-FU 2400mg/m2 CIV in 46h on Day 1 and 15.
15896367|NCT03678428|Drug|Oxaliplatin|Oxaliplatin 85 mg/m2 IV over 3 hours on Day1 and 15.
15896368|NCT03678415|Behavioral|Community-Based Primary Mental Health Care (CBPMHC) package|According to the intervention package, after receiving training, the service providers will start providing service according to learning to the enrolled mothers. The intervention package has developed in many maternal and psychosocial supports like psycho-educational communication about pregnancy complications, danger signs, birth preparedness; psycho-social support including information about psycho-education, graded activities and different types of alternative thoughts. Besides, in this regard the investigators included anxiety and depression disorders symptoms, postpartum mood disorders like postpartum blue, postpartum psychosis, etc. The primary healthcare service provider's provide intervention along with their daily routine and investigators follow it up by their visits.
15896369|NCT03678402|Device|PUP™ sock|The Palarum Fall Prevention System that includes the PUP™ (Patient is Up) System, is made upon of seven tangible elements: an inpatient room Android tablet (IRT), a nurse station Android monitor (HUC), a local server (PLS), a cloud server (PCS), a Bluetooth Low Energy beacon(s), an Android smart watch, and an e-textile sock connected sensor transmitter (PUP™ sock). The PUP™ sock monitors and transmits pressure, force, acceleration and motion data.
15896370|NCT03678389|Other|ESC|USE OF ENDOSPHENOIDAL COIL (ESC) TO OBTAIN MRI IMAGING OF THE PITUITARY GLAND
15896371|NCT03678376|Other|complaint, cognitive and functional assessments|"The evaluation with their GP is composed of (1-) Clinical impression, (2-) GP-Cog part 2 with patient or their informal caregiver and (3-) 6-CIT test.
~The identification of patients at risk of NCD with the new strategy applied by the GP will be compared to the gold standard for diagnosis of NCD at the Memory Clinic, established according to Diagnosis and Statistical Manual of mental disorders (DSM-5) criteria and based on a clinical, neuropsychological evaluation and functional abilities. If needed, a secondary etiological diagnosis procedure will be undertaken following the HAS 2011 recommendation including brain MRI and biology."
15896372|NCT03678363|Other|Tai chi chuan|Tai chi sessions will consist of repetition of simple and basic movements focusing mainly on breating, relaxation and body diagram. This Chinese martial art also includes coordination exercises of body parts (legs, arms, pelvis and spine), looseness and limbering up of joints and muscles.
15896373|NCT03678350|Device|Light Dosimetry for Intranoperative Therapy|Undergo IO-PDT
15896374|NCT03678350|Procedure|Photodynamic Therapy|Undergo IO-PDT
15896375|NCT03678350|Drug|Porfimer Sodium|Given IV
15896376|NCT03678337|Other|observational cohort with plasma samples|plasma samples
15896377|NCT03678324|Other|Functional MRI and fast bound-pool fraction imaging|"Use a form of MRI called fast bound-pool fraction imaging (FBFI), which is a technique better suited to capture and quantify these lesions, to study these lesions in patients with FD. In parallel, we would like to use functional MRI (fMRI) to study how these lesions alter brain function and connectivity in FD.
~Neuropsychological assessements will include Wechsler Adult Intelligence Scale, WAIS-III (Digit Span, Symbol-Digit/Coding, and Symbol Search), the Connors Continous Performance text (CPT-II). The Health Questionnaire form, the Center for Epidemiologic Studies Depression Scale (CES-D), the RAND 36-Item Health Survey."
15896378|NCT03678311|Device|Continuous Positive Airway Pressure (CPAP)|If diagnosed with Long QT Syndrome and have Sleep Apnea index >5 pauses per hour then given CPAP to wear for approximately 3 months.
15896379|NCT03678298|Other|Epidemiological/treatment profiles|All consecutively hospitalized adult patients (older than 18 years of age) undergoing surgery, interventional drainage or conservative treatment, with diagnosis of cIAIs (defined as abdominal infections originating in an organ cavity, extending into the peritoneal space, and forming an abscess or peritonitis, will be included in the study.
15896380|NCT03678285|Other|HIFRT Workout|A single high intensity functional resistance training (HIFRT) exercise bout.
15896381|NCT03678272|Procedure|HERNIOPLASTY WITH PANAVALE MESH|Polypropylene mesh fixed with 3 points. Preformed polypropylene mesh will be used by fixing it with one point to the pubis, another to the inguinal ligament and another to the joint tendon.
15896465|NCT03677713|Procedure|Nasal Packing|Patients will have nasal packing at the end of the surgery
15896382|NCT03678272|Procedure|HERNIOPLASTY WITH PARIETEX PROGRIP MESH|"Preformed polypropylene mesh will be used which presents a self adhesive system not based on glue, but on the arrangement of the fibers of the mesh as hooks, and to which we will give a single point to the pubis."
15896383|NCT03678272|Procedure|HERNIOPLASTY WITH ADHESIX MESH|It will use a self-adhesive mesh without giving points to fix this one, since it is a mesh that integrates the glue.
15896384|NCT03678272|Procedure|HERNIOPLASTY WITH TIMESH MESH|Titaniumized polypropylene mesh will be used without fixing points, since liquid cyanoacrylate (Ifabond) will be used to fix it.
15896385|NCT03678259|Drug|124I-p5+14 Injection|124I-p5+14 Injection which is a formulation of a synthetic, all natural, 45 amino acid peptide (MW = 4766.4) with a net +12 positive charge
15896386|NCT03678246|Procedure|Ramped position|LSFOI glottis view
15896387|NCT03678246|Procedure|Supine position|LSFOI glottis view
15896388|NCT03678233|Drug|AndroGel 16.2 mg/L|Testosterone gel 1.62 % will be applied to upper arms or shoulders once a day at 9:00 am to dry and intact skin for a period of 28 days or until ICU discharge. The daily dose 101.25 mg in men and 20.25 mg in women.
15896389|NCT03678220|Device|LapAR|LapAR system will be used for guidance during laparoscopic hepatectomy and laparoscopic liver thermal ablation
15896390|NCT03678207|Other|Anesthesiologist phone call|Patients receiving ambulatory surgery with no prior diagnosis of hypertension but have elevated blood pressure prior to surgery. Patients will receive a phone call from a participating anesthesiologist 1-3 days after surgery notifying them of their high blood pressure and obtaining oral consent to participate in the study. Patients will receive reminders via mail about following up with their PCP.
15896391|NCT03678194|Device|Smartphone Support System|6 weeks smartphone application with daily evaluations
15896392|NCT03678181|Behavioral|Information Resources|The investigators will provide a HIV-related content as the attention-control condition.
15896393|NCT03678181|Behavioral|Social Support|The investigators will provide evidence-based answers to users' health questions, including linkage to care.
15896394|NCT03678181|Behavioral|HIV Testing|The investigators will provide opportunities for participants to get tested through HIV home test kits.
15896395|NCT03678168|Other|Throat Pack|Post rhinology surgery throat packs will be used as a control to compare against the intervention (Pharyngeal tampons)
15896396|NCT03678168|Other|Pharyngeal Tampons|Post rhinology surgery Pharyngeal Tampons will be used as an intervention to compare against the throat pack (control)
15896397|NCT03678155|Other|pain app|Pain Monitor app has been developed by a multidisciplinary pain expert panel, including physicians, psychologists, and nurses. Content has been validated in a previous study and usability has been shown to be excellent.
15896398|NCT03678142|Diagnostic Test|analysis of last resort antibiotic drug (Flucloxacillin, Imipenem, Vancomycin or Cefepim) in sweat and blood|blood draw (4.7 ml EDTA) and sweat sample taken (Macroduct Sweat Collecting System)
15896399|NCT03678129|Drug|AZD7325_10|Single oral dose (10mg)
15896400|NCT03678129|Drug|AZD7325_20|Single oral dose (20mg)
15896401|NCT03678129|Drug|Placebo|Single oral dose placebo (capsule)
15896402|NCT03678116|Drug|Sugar Pill (placebo)|Taken orally in capsule form
15896403|NCT03678116|Dietary Supplement|Caffeine (plus Teacrine and Cayenne)|Taken orally in capsule form
15896404|NCT03678116|Dietary Supplement|Caffeine (plus Teacrine)|Taken orally in capsule form
15896405|NCT03678103|Device|INVSENSOR00029|Noninvasive pulse oximeter sensor
15896406|NCT03678090|Drug|tPA standard dosage|Tissue plasminogen activator 25mg dosage
15896407|NCT03678090|Drug|tPA low dosage|Tissue plasminogen activator 2.5mg
15896408|NCT03678077|Other|Mild traumatic brain injury|This is a register based observational study and does not include interventions. Exposure is mild traumatic brain injury.
15896409|NCT03678064|Device|Lokomat|16 sessions total. Provided by study PT twice weekly for a period of 8 weeks
15896410|NCT03678051|Behavioral|Treatment as Usual (TAU)|Standard of care residential treatment
15896411|NCT03678051|Behavioral|TAU+CBT4CBT|45-minute web-based modules covering core concepts to substance use treatment. The information is presented via graphics and voiceovers and key concepts are illustrated with brief videos depicting the material. Participants will be scheduled for a minimum of two sessions/week over the 3.5 weeks post-randomization (7 modules). These seven sessions will provide protected time to access the interventions, but the women will be able to access the modules and complete homework as much as they wish.
15896412|NCT03678038|Drug|Triamcinolone (Shincort) injection to rotator interval|via rotator interval.
15896413|NCT03678038|Drug|Triamcinolone (Shincort) injection to posterior glenuhumeral recess|via posterior glenuhumeral recess
15896414|NCT03678025|Drug|Abiraterone|Given PO
15896415|NCT03678025|Drug|Bicalutamide|Given PO
15896416|NCT03678025|Drug|Degarelix|Given via injection
15896417|NCT03678025|Drug|Docetaxel|intravenous
15896418|NCT03678025|Drug|Flutamide|Given PO
15896419|NCT03678025|Drug|Goserelin Acetate|Given SC
15896420|NCT03678025|Drug|Histrelin Acetate|Receive SC
15896421|NCT03678025|Drug|Leuprolide Acetate|Receive SC or IM
15896422|NCT03678025|Drug|Nilutamide|Given PO
15896423|NCT03678025|Procedure|Orchiectomy|Undergo bilateral orchiectomy
15896424|NCT03678025|Drug|Prednisone|Given PO
15896425|NCT03678025|Other|Quality-of-Life Assessment|Ancillary studies
15896426|NCT03678025|Radiation|Radiation Therapy|Standard radiation
15896427|NCT03678025|Procedure|Radical Prostatectomy|Standard surgery
15896428|NCT03678025|Drug|Triptorelin|injection
15896429|NCT03678012|Drug|Ferumoxytol/Hydrogen peroxide|1.5% Ferumoxytol / 3% Hydrogen Peroxide (H2O2) 1:1 ratio. Each subject will use this product during one of three treatment periods in the crossover study design.
15896430|NCT03678012|Drug|Hydrogen Peroxide|Sham Solution / 3% Hydrogen Peroxide (H2O2) 1:1 ratio. Each subject will use this product during one of three treatment periods in the crossover study design.
15896431|NCT03678012|Drug|Water|Sham solution (water; negative control). Each subject will use this product during one of three treatment periods in the crossover study design.
15896432|NCT03677999|Diagnostic Test|MEGA-PRESS sequence Magnetic Resonance Spectroscopy|MRS protocols and novel MRI methods that allow detection and quantification of 2 hydroxyglutarates (2HG) as well as the physiologic consequences of 2HG accumulation.
15896433|NCT03677986|Behavioral|Video DOT+|Participants will receive financial incentives for recording and submitting videos of themselves taking their daily buprenorphine dose.
15896434|NCT03677973|Drug|AB680|AB680 is a Cluster of Differentiation (CD)73 Inhibitor
15896435|NCT03677973|Other|Placebo|Matching Placebo
15896436|NCT03677960|Drug|Topical ABI-1968 cream|Multiple doses of Topical ABI-1968 Cream administered by the Investigator in the clinic up to Day 29
15896441|NCT03677921|Dietary Supplement|Investigational Product (Bio-Germanium)|"Ingredient: Bio-Germanium
~Type: HPMC capsule
~Weight: 300mg/capsule
~Directions: 2 capsules, twice a day (1.2g/day of Bio-Germanium)
~Storage: Room temperature (below 25℃)
~Duration of use: 8 weeks"
15896442|NCT03677921|Dietary Supplement|Control Group - Placebo Product|"Ingredient: Corn starch
~Type: HPMC capsule
~Weight: 300mg/capsule
~Directions: 2 capsules, twice a day
~Storage: Room temperature (below 25℃)
~Duration of use: 8 weeks"
15896443|NCT03677908|Other|ElectroEncephaloGraphy|Density ElectroEncephaloGraphy analysis
15896444|NCT03677895|Drug|Hyaluronic Acid|Hyaluronic Acid 2cc into subacromial bursa at weeks 0, 2 and 4
15896445|NCT03677882|Behavioral|Mind Body Bridging Group Session|Participants assigned to TAU + MBB will will receive treatment from the Suicide Prevention Team and the Mental Health Service, AND will be asked to participate in four, 90-minute Mind Body Bridging group sessions that will occur for four weeks in a row. Each group will involve up to 15 participants and will be led by a trained MBB facilitator. Participants will receive a workbook at the beginning of the training that contains an explanation of all the major concepts involved in Mind Body Bridging. The workbook has homework assignments to be completed daily between group sessions.
15896446|NCT03677869|Device|Intraocular gas (C3F8)|Intraocular gas (C3F8) injection
15896447|NCT03677856|Procedure|Paravertebral blockade|Type of anaesthesia
15896448|NCT03677856|Procedure|Thoracic epidural block|Type of anaesthesia
15896449|NCT03677830|Drug|Acetaminophen|Scheduled intravenous acetaminophen for post-operative pain to minimize opiate exposure.
15896450|NCT03677830|Drug|Saline|Intravenous saline will be administered at appropriate volume and schedule for control group as a placebo.
15896451|NCT03677817|Drug|Lidocaine|regimen of lidocaine administration of 1,5 mg/kg, IV bolus, followed by continuous infusion at 3,0 mg/kg/h
15896452|NCT03677817|Drug|NaCl 0,9%|IV bolus of NaCl 0,9%, followed by continuous infusion of NaCl 0,9%
15896453|NCT03677791|Other|Virtual tour in coronary computed tomography - 360° counselling environment|Virtual tour in coronary computed tomography - 360° counselling environment for CCTA patients
15896454|NCT03677791|Other|Current practice|counselling in accordance with current practice: written patient information letter and verbal counselling at the hospital during the CT-examination
15896455|NCT03677778|Procedure|Normal saline injected via interscalene nerve catheter|With the catheter covered, treatment group patients will receive a normal saline (NS) bolus regimen (30cc 0.9% NS) via their interscalene nerve block catheter.
15896456|NCT03677778|Other|Placebo|With the catheter covered, placebo group patients will go through the same steps as the treatment group, but no solution will be injected into the interscalene nerve block catheter.
15896457|NCT03677765|Procedure|Supra- vs Infraclavicular approach using ultrasonography|In the supraclavicular group, subclavian venous catheterization using ultrasonography is performed beneath the clavicle. Meanwhile, in the infraclavicular group, subclavian venous catheterization using ultrasonography is performed over the clavicle.
15896458|NCT03677752|Other|GP_Posit|Mother-infant dyads allocated to this arm will receive the GP_Posit intervention. The intervention consists of a guided participation intervention to positioning. Mothers will meet with the intervention nurse twice a week for the two first weeks after birth and then one a week until the infant will reach 35 weeks of gestational age. During these encounters, mothers will learn how to interpret their infant's stress and stability cues and participate in his/her care and positioning while being guided by the intervention nurse.
15896462|NCT03677726|Behavioral|Mindfulness Based Therapy for Insomnia|The mindfulness-based intervention consists of eight 2-hour sessions covering various mindfulness techniques (e.g. mindfulness of breath, body and movement, senses and informal practice, and empathy and compassion) that pertain to people with sleep problems and insomnia. Participants will be provided handouts for the information covered during these talks and discussions.
15896463|NCT03677726|Other|Sleep Hygiene Education Exercise Program|The Sleep Hygiene Education and Exercise Program has known relationships with good sleep quality. It will comprise 8 weekly 2-hour sessions. Each session will introduce a concept related to sleep and sleep hygiene. The facilitator will provide the theory and rationale behind the concept, and encourage participants to share and discuss their experiences related to the concept. The session will end with the participants evaluating how to implement the specific concept in their daily lives, and its potential implications for their sleep. Participants will be provided with a manual that outlines the concept and how they intend to apply it to their daily lives.
15896499|NCT03677375|Device|INVSENSOR00026|Noninvasive pulse oximeter sensor
15896466|NCT03677700|Other|Laser Flare Meter|Measurement of the inflammation of the operated eye and the fellow eye before the surgery and at each post-surgery visit: D7, M1, M2, M3, M6, M12
15896467|NCT03677687|Behavioral|Mindfulness for Physical Activity|The Mindfulness for Physical Activity (MfPA) programme aims to change participants' relationship with physical activity by targeting psychological factors related to physical activity uptake and maintenance.
15896468|NCT03677674|Other|Dehydration|Participants will be dehydrated (2% of their body weight) using sauna.
15896469|NCT03677661|Other|Conventional approach|The intervention will consist of light cognitive and physical activity with no symptoms exacerbation followed by graded exertion. Participant will be evaluated by a neuropsychologist. The neuropsychological intervention will consist of advice relative to cognitive rest in line with the clinical evaluation results followed by an individualized step-by-step graded exposition to cognitive stimulus according to symptoms evolution. A kinesiologist will also evaluate the symptoms response to cardio-vascular exertion. According to the result of this clinical evaluation, a graded physical exercise program will be given to the participants. 8 in-clinic cardio-vascular exercise sessions in a 6-week period supervised by the kinesiologist (30 to 45 minutes each session) will be provided.
15896470|NCT03677661|Other|Personalized rehabilitation program|The same advice and exercise program than the active comparator group will be provided. However, 2 physiotherapists will provide 8 treatment session ( 30 to 45 minutes). One physiotherapist will initially evaluate the physical dysfunctions associated to mTBI with a standardized evaluation to build the treatment plan. He will provide cervical manual therapy and therapeutic exercises based on the best current clinical approach and according to the impairment specifically found initially. A vestibular physiotherapist will provide treatment of canalith repositioning manoeuvre, vestibular adaptation, ocular motor exercises, balance and/or habituation exercises. This treatment will be adapted to the individual patient. No more than 8 sessions will be delivered.
15896473|NCT03677635|Behavioral|Guided Autobiographical Memory Recall|Participants are asked to recall positive autobiographical memories with the assistance of prompts to promote specificity, generalisability and links to the future. The participants will also view a 5min psychoeducation video on the subject of memory specificity and motivation.
15896474|NCT03677622|Drug|Voluven to near maximal stroke volume of the heart|Stroke volume guided fluid treatment with Voluven on the basis of restricted fluid therapy
15896475|NCT03677609|Behavioral|Mindset & Communication Training|The mindset training is a two-hour, live training, with a one-hour follow-up one month later, that teaches care providers to recognize, shape, and leverage patient mindsets in healthcare.
15896476|NCT03677596|Drug|inotuzumab ozogamicin-dose level 2|Inotuzumab ozogamicin (BESPONSA™) is a CD22 targeted antibody drug conjugate (ADC) approved by US FDA for treatment of adults with relapsed or refractory B cell precursor acute lymphoblastic leukemia (ALL). The approved starting dose is 1.8mg/m2/cycle. This treatment arm evaluates a lower starting dose of 1.2mg/m2/cycle.
15896477|NCT03677596|Drug|Inotuzumab ozogamicin-dose level 1|Inotuzumab ozogamicin (BESPONSA™) is a CD22 targeted antibody drug conjugate (ADC) approved by US FDA for treatment of adults with relapsed or refractory B cell precursor acute lymphoblastic leukemia (ALL). The approved starting dose of 1.8mg/m2/cycle is administered in this treatment arm.
15896478|NCT03677583|Other|Duckweed|various meal products such as meal soup, quiche, mashed potato, curry and pasta sauce
15896479|NCT03677583|Other|Spinach|various meal products such as meal soup, quiche, mashed potato, curry and pasta sauce
15896480|NCT03677570|Diagnostic Test|postural stability|Postural Stability, vertical jump test, hexagonal obstacle test, trunk flexion test, trunk extension test, side bridge test,prone bridge test
15896481|NCT03677557|Drug|16,5% Cutaquig|Participants with primary or secondary immunodefiiciney disease and who do not tolerate other immunoglobulin treatments will be asked to use 16.5% Cutaquig
15896482|NCT03677544|Other|laparoscopic approach with an extended pelvic lymph|Surgery was performed through either open or laparoscopic approach with an extended pelvic lymph node dissection up to the common iliac bifurcation
15896483|NCT03677531|Other|Quality-of-Life Assessment|Ancillary studies
15896484|NCT03677531|Other|Questionnaire Administration|Ancillary studies
15896485|NCT03677531|Radiation|Radiation Therapy|Undergo RT
15896486|NCT03677531|Other|Video|Watch video of choice during RT
15896487|NCT03677505|Device|KoMAC videolaryngoscope|Double lumen endotracheal intubation was performed with the KoMAC videolaryngoscope
15896488|NCT03677505|Device|Macintosh Laryngoscope|Double lumen endotracheal intubation was performed with the Macintosh Laryngoscope
15896489|NCT03677492|Other|Medium Supplemented with Cytochalasin D|A medium with in-house supplementation of Cytochalasin D to decrease oocyte degeneration after ICSI and improve the survival rate
15896490|NCT03677479|Procedure|socket preservation procedure|socket preservation of post extraction site using bone xenografts
15896491|NCT03677466|Drug|Pharmaco-invasive strategy|"Patient with primary STEMI will received standard doses of fibrinolytics with following PCI.
~After reperfusion strategies will be conducted cardiovascular magnetic resonance (CMR) imaging with contrast (Gadovist) in regime inversion recovery time, regime T-2 weighted images, T1-weighted images. and Global Longitudinal Strain measured with echocardiography."
15896492|NCT03677466|Procedure|Primary PCI|After primary PCI patients will be conducted cardiovascular magnetic resonance (CMR) imaging with contrast (Gadovist) in regime inversion recovery time, regime T-2 weighted images, T1-weighted images and Global Longitudinal Strain measured with echocardiography.
15896493|NCT03677453|Other|Interactive Perioperative Teaching Platform|An active video format will be used to provide instructions for navigating the hospital; describe induction of anesthesia and the surgical procedure; and provide post-surgery and post-discharge instructions for pain management.
15896494|NCT03677440|Behavioral|Treadmill Walking Exercise Training|12-weeks of supervised, progressive treadmill walking exercise training
15896495|NCT03677440|Behavioral|Stretching-and-Toning Exercise Training|12-weeks of supervised, progressive stretching-and-toning exercise training
15896496|NCT03677427|Radiation|Radiation|Radiation in breast cancer
15896497|NCT03677401|Drug|5mg Serlopitant Tablets|Serlopitant Tablets
15896498|NCT03677401|Drug|Placebo Tablets|Placebo Tablets
15896500|NCT03677362|Behavioral|Weight loss intervention|In the WLI, energy intake will be prescribed at 1200-1500 kcal/d using commercially available portion-controlled entrées, low calorie shakes, fruits/vegetables, and ad-libitum non-caloric beverages. Participants will be asked to consume a minimum daily total of 2 entrées (~200 to 300 kcal each, saturated fat ≤ 3g), 3 shakes (~100 kcal each), five 1-cup servings of fruits/vegetables, and ad libitum non-caloric beverages. Additionally, they will be asked to complete 225 min of moderate intensity PA, and self-monitor diet, PA (self-report) and body weight (home scale) across the 6 mo. intervention. Weekly behavioral counseling sessions (45 min) via group phone callsSkype will be delivered by a professional health educator (HE) to participants in their homes.
15896501|NCT03677349|Procedure|neurorrhaphy|"During the surgery, the flap is removed from its donor site, placed on the recipient site (instead of carcinological excision) and its survival is ensured by arterial and venous anastomosis (to the artery and facial vein or to the external carotid artery and thyro-linguofacial veinous trunk).
~We then propose a reconstruction complement: nerve anastomosis (neurorrhaphy) to the lingual nerve for the antebrachioradial and anterolateral thigh flaps, and to the lower alveolar nerve for the fibular bone flaps. This supplement is performed during microsurgical time by a suture for the patient in group 1."
15896502|NCT03677336|Drug|Dydrogesterone Oral Tablet|Tablet, oral, 10 mg, 3 times daily, starting on the day of oocyte retrieval in the morning and during 8 days
15896503|NCT03677336|Drug|Micronized progesterone|Capsule, vaginal, 200 mg, 3 times daily, starting on the day of oocyte retrieval in the morning and during 8 days
15896504|NCT03677336|Drug|Placebo Dydrogesterone oral tablet|Tablet, indistinguishable from dydrogesterone oral tablet
15896505|NCT03677336|Drug|Placebo Micronized progesterone|Capsule, indistinguishable from micronized vaginal progesterone capsules
15896506|NCT03677323|Device|Virtual reality|"The patient will have the choice between different environments and the use of this device will remain under the control of the medical team.
~The patient will wear the virtual reality device at the time of the completion of the ankle block and will remove it once the nerve puncture is complete."
15896507|NCT03677323|Drug|Droleptan|Venous administration of 1.25 mg of Droleptan
15896508|NCT03677323|Drug|Propofol|Venous administration of 20 mg of Propofol
15896509|NCT03677323|Drug|Sufentanyl|Venous administration of 5 μg of Sufentanyl.
15896510|NCT03677310|Drug|3% Sodium Chloride|3% sodium chloride will be given intravenously at a rate of 10 cc/hour over a period of 24 hours beginning immediately prior to incision.
15896511|NCT03677310|Drug|Normal Saline|Normal Saline will be given intravenously at a rate of 10 cc/hour over a period of 24 hours beginning immediately prior to incision.
15896512|NCT03677297|Drug|Rosuvastatin|Test sites were treated with access flap surgery and 1.2% Rosuvastatin gel
15896513|NCT03677284|Other|Time assistive products|The decision on the specific time assistive product to be prescribed will be decided based on current knowledge and the personal goal of the PwD.
15896514|NCT03677284|Other|Information brochure|The information brochure will provide information frequent problems about daily time management and suggest strategies to manage them.
15896515|NCT03677271|Behavioral|Physical Activity|
15896516|NCT03677258|Device|Collagen for injections 7%|Injection of medical device
15896517|NCT03677258|Device|Hyaluronic acid for injections 2%|Injection of medical device
15896518|NCT03677245|Other|Strider Balance Bike|Learning to ride a Strider balance bike
15896519|NCT03677219|Other|Educational Video|The educational video is a 2 minute video depicting a live lumbar puncture on an infant interwoven with animations of the relevant anatomy.
15896520|NCT03677206|Device|Exposure to green LED light|Participants will be exposed to green LED strip lights in a dark room for 2 hours a day.
15896521|NCT03677206|Device|Exposure to white LED light|Participants will be exposed to white LED strip lights in a dark room for 2 hours a day.
15896522|NCT03677193|Behavioral|Playing ICP game|Participants will play the ICP game from their home this is expected to be 30 min * 5 days / week for 4 weeks. Once per week, participants will play the ICP game with a researcher.
15896523|NCT03677167|Other|walking on a treadmill|Patients will go on the treadmill (barefoot or with shoes) twice a week for a month, up to a medium-high level effort, and will receive ultrasound treatment for the painful heel spot
15896528|NCT03677141|Drug|Mosunetuzumab|Participants will receive intravenous (IV) mosunetuzumab.
15896529|NCT03677141|Drug|Polatuzumab Vedotin|Participants will receive polatuzumab vedotin via IV.
15896530|NCT03677141|Drug|Rituxumab|Participants will receive rituxumab via IV.
15896531|NCT03677141|Drug|Cyclophosphamide|Participants will receive cyclophosphamide via IV.
15896532|NCT03677141|Drug|Doxorubicin|Participants will receive doxorubicin via IV.
15896533|NCT03677141|Drug|Vincristine|Participants will receive vincristine via IV.
15896534|NCT03677141|Drug|Prednisone|Participants will receive oral prednisone.
15896535|NCT03677141|Drug|Tocilizumab|Participants will receive tocilizumab via IV.
15896536|NCT03677128|Other|mNavigator|Allied health providers at BMC will use mNavigator to facilitate compliance with protocol-driven treatment and reduce patient abandonment for patients diagnosed with Burkitt lymphoma, Diffuse large B-cell lymphoma or retinoblastoma.
15896537|NCT03677115|Drug|Dexmedetomidine|combination of ropivacaine and dexmedetomidine 20 ug every time
15896538|NCT03677102|Other|higher chloride crystalloid|Normal saline (chloride concentration 154 mmol/L)
15896539|NCT03677102|Other|lower chloride crystalloid|Ringer's Lactate (chloride concentration 110 mmol/L)
15896540|NCT03677089|Behavioral|12 ECHO Autism telehealth clinics|Twice-monthly 2-hour ECHO Autism Clinics will be provided during a 6-month period. Each Clinic will include a didactic presentation, 2 to 3 Primary Care Provider-generated case presentations, expert feedback, and group discussion. Although the ECHO Clinic will include discussion of specific cases, no identifiable personal health information will be shared, individual patients will not be identified, and no direct patient care will be provided.
15896542|NCT03677063|Other|No dressing|Then, care is the same and exit-site remains covered with an occlusive dressing to promote tunnel epithelialization and healing. The shower is forbidden during this period.
15896543|NCT03677050|Other|Smart phone patient education application|Smart phone patient education application including a personalized colonoscopy preparation scheme and information about the procedure.
15896544|NCT03677037|Other|Short-term MBT|Short-term mentalization-based therapy
15896545|NCT03677037|Other|Long-term MBT|Long-term mentalization-based therapy
15896546|NCT03677024|Procedure|SLN arm|Intra-operative SN mapping with indocyanin green: Intracervical injection will be performed by the surgeon. Sub-mucous injections will be performed with 50% diluted dye at 3 and 9 o'clock positions. 1ml injection contained infracyanine green will be injected deeply into the stroma of the cervix (1cm-depth), and another 1ml will be injected superficially (2mm-depth). The time between the injection and the search for SLN must be as soon as possible.
15896547|NCT03677011|Diagnostic Test|Andrositol® Test|The intervention consists in the addiction of myo-inositol directly to the semen identifying the quality of sperm prior ICSI procedure
15896548|NCT03676998|Device|Measurement of diaphragm function|A bilateral magnetic stimulation induces a non voluntary diaphragm contraction and a drop in airway pressure that is measured.
15896549|NCT03676985|Drug|ZKAB001 5mg/kg|5mg/kg/times bi-week IV administration of ZKAB001
15896550|NCT03676985|Drug|ZKAB001 10mg/kg|10mg/kg/times bi-week IV administration of ZKAB001
15896551|NCT03676985|Drug|ZKAB001 15mg/kg|15mg/kg/times bi-week IV administration of ZKAB001
15896552|NCT03676972|Device|LithoVue Ureteroscope System|The LithoVue System is intended to be used to visualize organs, cavities and canals in the urinary tract (urethra, bladder, ureter, calyces and renal papillae) via transurethral or percutaneous access routes.
15896553|NCT03676959|Drug|ZKAB001 5mg/kg|5mg/kg/times bi-week IV administration of ZKAB001
15896554|NCT03676959|Drug|ZKAB001 10mg/kg|10mg/kg/times bi-week IV administration of ZKAB001
15896555|NCT03676959|Drug|ZKAB001 15mg/kg|15mg/kg/times bi-week IV administration of ZKAB001
15896556|NCT03676946|Drug|ZKAB001 5mg/kg|5mg/kg/times bi-week IV administration of ZKAB001
15896557|NCT03676946|Drug|ZKAB001 10mg/kg|10mg/kg/times bi-week IV administration of ZKAB001
15896558|NCT03676946|Drug|ZKAB001 15mg/kg|15mg/kg/times bi-week IV administration of ZKAB001
15896559|NCT03676933|Drug|DS107E|
15896560|NCT03676933|Drug|Vehicle|
15896561|NCT03676933|Drug|Hydrocortisone Butyrate 0.1% Cream|Steroid taken topically once a day
15896562|NCT03676920|Behavioral|Discussions of Cost App (DISCO App)|The DISCO App is an app-based and patient-focused intervention designed to improve the frequency and quality of patient-oncologist treatment cost discussions. The DISCO App allows patients to provide basic demographic information (e.g., employment status, insurance status, etc), and uses that information to provide patients with an individually-tailored list of treatment cost questions they can ask their provider.
15896563|NCT03676907|Procedure|double layer suturation technique|in our clinic uterine incision is sutured by single layer suturation technique routinely. in this arm, we will use double layer suturation technique which is also accepted as valid suturation technique in obstetrics and gynecology textbooks
15896564|NCT03676894|Device|Sham Fotona SP Dynamis|Female patients with SUI will be treated with non-ablative Er:YAG laser with Fotona SP Dynamis with sham handpiece.
15896565|NCT03676894|Device|Intravaginal Fotona SP Dynamis|Female patients with SUI will be treated intravaginaly with non-ablative Er:YAG laser with Fotona SP Dynamis
15896566|NCT03676894|Device|Intraurethral Fotona SP Dynamis|Female patients with SUI will be treated intraurethraly with non-ablative Er:YAG laser with Fotona SP Dynamis
15896567|NCT03676881|Device|Computerized cognitive battery: Cognigram (CG)|is a validated, computerized battery of cognitive tasks based on card games, developed by Cogstate Ltd. This technology includes four tasks, with a total duration of 10-15 minutes. The subject is asked to answer each task by pressing either 'D' or 'K' keyboard buttons. The technology supports the measurement of attention/vigilance, processing speed, concentration, visual working memory and visual recognition memory. The software will run on a computer supplied by the Bruyère Research Institute, in a private test room. The RA will be present during the testing session, reading out loud the batteries standardized instructions and doing the practice trials with the participants. After the practice trials, the RA will not give any feedback or support.
15896568|NCT03676881|Device|The NeuroCatch™ Platform (NCP)|the NCP includes 6 stimulus sequences specifically designed to elicit desired brain responses. Each sequence contains both the oddball task and semantic word-pair task, and lasts 6 minutes. In our protocol, two sequences will be used. For the setup, EEG electrodes are placed on the participant's scalp, and the EEG signal quality is ensured by gently abrading the skin beneath each of the electrodes. A conductive gel is then placed between the skin and the electrode. Most electrodes are contained in an elastic cap, which is worn by the participants, but some electrodes are attached to the skin with adhesive. This part of the session takes around 10 minutes. EEG scan will commence once the setup is completed. Two auditory scans of 6 minutes each, separated by a one-minute break, will be administered. The total time of EEG testing for participants, including setup, will be of ≈25 minutes.
15896569|NCT03676855|Procedure|bladder dissection|Comparison between bladder dissection at the beginning of cesarean section For morbidly adherent placenta and between delaying dissection until planning for cesarean hysterectomy
15896570|NCT03676842|Combination Product|FLEX Dynamic Scoring Catheter with IN.PACT Admiral DCB|Treatment by the FLEX Scoring Catheter followed by an IN.PACT Admiral DCB
15896571|NCT03676829|Device|Arterial Embolization of the Shoulder|Arterial Embolization of the Shoulder (AES) is a new procedure that is being used to reduce pain and improve range of motion (ROM) caused by adhesive capsulitis. Embolization is a procedure where physicians intentionally block the blood vessels to specific areas of the body to prevent blood flow to that region. By doing this, the decrease in blood flow will decrease the size of the area of interest. In this case, the goal is to decrease the size of inflammatory tissue around the shoulder, resulting in improvement of pain, stiffness and from adhesive capsulitis.
15896572|NCT03676816|Procedure|vaginal self sampling|This is a prospective, non-inferiority trial comparing two methods of collection using a US Food and Drug Administration- cleared 90-minute rapid nucleic acid amplification assay, the Xpert CT/NG assay. Any adult female patient admitted to the Emergency Department at Community Regional Medical Center felt by the provider to require gonorrhea/chlamydia endocervical testing may be entered in the study.
15896573|NCT03676816|Procedure|provider-performed endocervical sampling|provider-performed endocervical sampling is the gold standard for both gonorrhea and chlamydia. The provider takes a endocervical sample which will get sent to the laboratory as the standard care in comparison to the device being studied.
15896574|NCT03676803|Other|mixed spices|All spices in the spice mixture capsules contains 1g or 20% cinnamon, 1.5g or 30% oregano, 1.5g or 30% ginger, 0.85g or 17% black pepper, 0.15g or or 3% cayenne pepper for a total of 5.0g spice mixture. They are identical to herbs and spices sold in grocery stores for human consumption.
15896575|NCT03676803|Other|placebo capsule containing 5 g of maltodextrin|placebo capsule containing 5 g of maltodextrin
15896576|NCT03676790|Other|Group I|"Group I In the first month, continuous ultrasound was applied three times a week. In the second month, patients performed only exercise sessions three times a week. In the ultrasound treatment, the following parameters were used: frequency of 1 MHz, intensity of 1.5 W/cm2 (temporal and spatial mean SATA), duty cycle of 100%, with application time of 5 minutes on the medial side and 5 minutes on lateral side of knee.
~Exercises
~The intervention was divided into three phases: P-1, P-2 and P-3 during eight weeks with three sessions a week. Each session lasted 45 minutes:
~10 minutes warming-up (treadmill, ergometer bike or rowing machine);
~30 minutes 2-3 sets with P-1, P-2 or P-3;
~5 minutes stretching (hamstrings, quadriceps, adductors, and gastrocmenius)."
15896577|NCT03676790|Other|Group II|"Group II In the first month, pulsed ultrasound was applied three times a week. In the second month, patients performed only exercise sessions three times a week. In the treatment with the US, the following parameters were used: 1 MHz frequency, 2.5 w / cm2 intensity (temporal and spatial mean SATA), pulsed mode (25%), 5 minutes on the medial side and 5 minutes on the lateral side of the knee.
~Exercises
~The intervention was divided into three phases: P-1, P-2 and P-3 during eight weeks with three sessions a week. Each session lasted 45 minutes:
~10 minutes warming-up (treadmill, ergometer bike or rowing machine);
~30 minutes 2-3 sets with P-1, P-2 or P-3;
~5 minutes stretching (hamstrings, quadriceps, adductors, and gastrocmenius)."
15896578|NCT03676790|Other|Group III|"Group III In the first month, the continuous ultrasound was applied 3 times a week. In the second month, 3 times a week, the continuous ultrasound was applied associated with exercises. The parameters were used: frequency of 1 MHz, intensity of 1.5 w / cm2 (temporal and spatial mean SATA), continuous mode (100%), with application time of 5 minutes on the medial side and 5 minutes on lateral side of knee.
~Exercises
~The intervention was divided into three phases: P-1, P-2 and P-3 during eight weeks with three sessions a week. Each session lasted 45 minutes:
~10 minutes warming-up (treadmill, ergometer bike or rowing machine);
~30 minutes 2-3 sets with P-1, P-2 or P-3;
~5 minutes stretching (hamstrings, quadriceps, adductors, and gastrocmenius)."
15896579|NCT03676790|Other|Group IV|"Group IV In the first month, the pulsed ultrasound was applied three times a week. In the second month, three times a week, the pulsed ultrasound associated with exercises was applied. In the treatment with the US, the following parameters were used: 1 MHz frequency, 2.5 w / cm2 intensity (temporal and spatial mean SATA), pulsed mode (25%), 5 minutes on the medial side and 5 Minutes on the lateral side of the knee.
~Exercises
~The intervention was divided into three phases: P-1, P-2 and P-3 during eight weeks with three sessions a week. Each session lasted 45 minutes:
~10 minutes warming-up (treadmill, ergometer bike or rowing machine);
~30 minutes 2-3 sets with P-1, P-2 or P-3;
~5 minutes stretching (hamstrings, quadriceps, adductors, and gastrocmenius)."
15896580|NCT03676790|Other|Group V|"Group V Patients received only exercise sessions three times a week for two months.
~Exercises
~The intervention was divided into three phases: P-1, P-2 and P-3 during eight weeks with three sessions a week. Each session lasted 45 minutes:
~10 minutes warming-up (treadmill, ergometer bike or rowing machine);
~30 minutes 2-3 sets with P-1, P-2 or P-3;
~5 minutes stretching (hamstrings, quadriceps, adductors, and gastrocmenius)."
15896581|NCT03676764|Drug|Azithromycin|biannual azithromycin in eligible communities to children 1 to 59 months old Targeted azithromycin to children aged 5 to 8 weeks old at the vaccine visit
15896582|NCT03676764|Drug|Placebos|biannual placebo in eligible communities to children 1 to 59 months old Targeted placebo to children aged 5 to 8 weeks old at the vaccine visit
15896583|NCT03676751|Drug|Azithromycin|Zithromax® for oral suspension is supplied in bottles containing azithromycin dehydrate powder equivalent to 1200mg per bottle and the following inactive ingredients: sucrose; tribasic anhydrous sodium phosphate; hydroxypropyl cellulose; xanthan gum; FD&C Red #40; and flavoring including spray dried artificial cherry, crème de vanilla, and banana. After constitution, a 5mL suspension contains 200mg of azithromycin.
15896584|NCT03676751|Drug|Placebo|Oral suspension of placebo for azithromycin
15896585|NCT03676725|Drug|Lidocaine gel|Lidocaine gel (0.75 g premeasured dose of Septodont 5% oral gel NDC 0362-0221-10)
15896586|NCT03676712|Device|scoliosis brace|Wear at least 18 hours a day
15896587|NCT03676699|Diagnostic Test|Ultrasound chest|Ultrasound detection of extravascular lung water
15896588|NCT03676686|Device|Nåva Foot Cream|Nåva Foot Cream is a Medical device (EU class IIa) for the treatment of tinea pedis, heal cracks, calluses and dry feet.
15896589|NCT03676673|Other|Psychiatric diagnosis|Kiddie Schedule for Affective Disorders & Schizophrenia (K-SADS) for DSM-5
15896590|NCT03676647|Other|Diagnostic DNA Methylation Signature|Undergo collection of tissue samples
15896592|NCT03676621|Drug|Misoprostol|buccal tablets
15896593|NCT03676621|Drug|Oxytocin|intravenous drip
15896594|NCT03676608|Biological|Bee Wax Mammary Areolae|The product to be valued are mammary areolae made by hand with organic beeswax. Despite its honey aroma, it does not contain honey. The wax used for the manufacture of the areolae is operculum. This wax is used and not another because it avoids possible residues and allergies that may contain other types of waxes. The operculum wax is used as a thickener in pharmacy and cosmetic products as a fat base in ointments and creams.
15896595|NCT03676608|Other|Usual educational care|The WHO protocol for maternal lactation.
15896596|NCT03676595|Other|interactive video game-based exercise|Twenty-four patients were randomly assigned to two groups (12 participants per group). Group A received interactive video game-based exercise training for the first 6 weeks, with no exercise in the subsequent 6 weeks. Group B had no exercise for the first 6 weeks and then underwent interactive video game-based exercise training in the subsequent 6 weeks.
15896625|NCT03676335|Drug|CsA eye gel|The CsA eye gel of 0.3 g: 0.15 mg, 0.3 g: 0.3 mg
15896626|NCT03676335|Drug|CsA for eye emulsion|The CsA for eye emulsion of 0.4 ml: 0.2 mg
15896597|NCT03676595|Other|no exercise|Twenty-four patients were randomly assigned to two groups (12 participants per group). Group A received interactive video game-based exercise training for the first 6 weeks, with no exercise in the subsequent 6 weeks. Group B had no exercise for the first 6 weeks and then underwent interactive video game-based exercise training in the subsequent 6 weeks.
15896598|NCT03676582|Diagnostic Test|Acoustic analysis plus pulse oximetry|Acoustic analysis plus pulse oximetry
15896599|NCT03676569|Biological|ADRC transplantation in autoimmune refractory epilepsy|
15896600|NCT03676556|Drug|Lidocaine|Two sterile gauzes will be dampen with the content of the syringe (20ml lidocaine 0.5%) and apply on the wound. After 7-15minutes of waiting to the effect, the wound treatment will start.
15896601|NCT03676556|Drug|Saline Solution|Two sterile gauzes will be dampen with the content of the syringe (20ml saline serum) and apply on the wound. After 7-15minutes of waiting to the effect, the wound treatment will start.
15896602|NCT03676543|Procedure|Timed repetitive sensory stimulation|Timed repetitive sensory stimulation (TRSS) will be applied at the onset or during seizures
15896603|NCT03676530|Device|Pro-Tec Shin Splint Compression Wrap|EVA Foam pad compression device with Velcro straps that is placed over tibial site of pain.
15896604|NCT03676517|Radiation|preoperative short-course radiotherapy|1-week short-course radiation (5 Gy x 5) plus 6-week XELOX (capecitabine 1,000mg/m2 and oxaliplatin 130mg/m2 every 3 weeks) chemotherapy before total mesorectal excision (TME)
15896605|NCT03676504|Biological|CD19.CAR T Cells|Dose Level 1: 1×10^6 transduced cells/m^2; Dose Level 2: 5×10^6 transduced cells/m^2; Dose Level 3: 20×10^6 transduced cells/m^2; Dose Level 4: 5x10^7 transduced cells/m^2; Dose Level 5: 10x10^7 transduced cells/m^2; Dose Level 6: 20x10^7 transduced cells/m^2
15896606|NCT03676504|Drug|Fludarabine|3 days of fludarabine 30 mg/m^2/day
15896607|NCT03676504|Drug|Cyclophosphamide|3 days of cyclophosphamide 500 mg/m^2/day
15896608|NCT03676491|Other|Music Intervention|Music intervention
15896609|NCT03676478|Other|delayed start enteral support @ POD5|instead of caloric suppletion, participants will receive 500mls of water over the jejunostomy feeding tube daily.
15896610|NCT03676465|Other|CloudConnect Report|Subjects and their parents will be asked to download the data from the study devices as well as download their insulin pump/pen. The participants will receive a weekly CloudConnect Report that is based on analysis of the data gathered from the downloads provided by the subject during that week. Participants will both receive weekly contact from the study team to discuss the communication that the subject & their parent had during the week about the participant's diabetes management.
15896611|NCT03676465|Other|Will not receive a CloudConnect Report|Subjects and their parents will be asked to download the data from the study devices as well as download their insulin pump/pen. Participants will receive weekly contact from the study team to discuss the communication that the subject & their parent had during the week about the participant's diabetes management.
15896612|NCT03676452|Behavioral|Active@Home exergame training|The Active@Home exergame is a multicomponent, motor-cognitive training for fall prevention in elderly adults. It mainly consists of three components; strength training, balance training and cognitive training. For strength training, Tai Chi-based movements are included. For balance training, dancing is included in the Active@Home exergame. Moreover, the Active@Home exergame explicitly targets specific attentional and executive functions. The Active@Home system set up is easy and consists of an HDMI dongle (to run the application) which must be plugged into the TV and four wearable sensors (to measure the movements).
15896613|NCT03676439|Device|Magnetic Spinal Stimulation|"Spinal Magnetic Stimulation (TMS) on Lateral Cord Stimulation (LCS), in the search of the improvement of the tone, motor function and speech, in patients with spastic cerebral Palsy.
~Due to its non-invasiveness and possible efficacy, the use of Magnetic Spinal Stimulation is proposed to try to prove its therapeutic usefulness.
~This is the phase 2/3 clinical test of the method, in the future, and as its use could be extended, if the results were positive, its indications could be extended to other pathological conditions, giving a greater spectrum of spastic patients, potentially benefited."
15896614|NCT03676426|Other|Web platform for advance care planning/advance directive|Ourcarewishes (OCW) is a web-based platform to document advance care planning based at Penn. OCW contains more detailed content on preferences and values than a standard advance directive and allows electronic sharing with loved ones and transmission to the Penn EHR.
15896615|NCT03676426|Other|Standard advance directive|Patients receive a paper copy of an advance directive used by social workers at Penn Medicine and are encouraged to complete on their own.
15896616|NCT03676413|Drug|Fluticasone Propionate 100 mcg and Salmeterol 50 mcg inhalation Powder/Respirent Pharmaceuticals|new generic product of Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder twice daily inhalation throughout the study
15896617|NCT03676413|Drug|ADVAIR DISKUS® 100/50 mcg inhalation powder pre-dispensed/GSK|twice daily inhalation throughout the study
15896618|NCT03676413|Drug|Placebo|twice daily inhalation throughout the study
15896619|NCT03676400|Other|conditioned media of umbilical cord blood-derived stem cells|Hair serum with 5% conditioned media of human umbilical cord blood-derived mesenchymal stem cells
15896620|NCT03676400|Other|Placebo|Hair serum without conditioned media of human umbilical cord blood-derived mesenchymal stem cells
15896621|NCT03676387|Other|ultrasound guided|"Ultrasonography technique:
~The subglottic diameter was estimated with B-mode ultrasonography (Korean, Siemens, Acuson, x300) with a 10-13-MHz linear probe positioned on the midline of the anterior neck (figure1). The evaluation began by identifying the true vocal folds as paired hyperechoic linear structures that moved with respiration and swallowing before patients were paralyzed. The probe was then moved caudally to visualize the cricoid arch which appears as an arched, rounded and hypoechoic structure (figure2). The transverse air-column diameter was measured at the lower edge of the cricoid cartilage after patients were paralyzed (figure3).
~The measurements of the subglottic diameter was used to select the outer diameter of endotracheal tube by the equation [ETT OD=0.55*(subglottic diameter)+1.16] (Shibasaki et al., 2010), since the outer diameter of endotracheal tube differs among different manufactures, we used uncuffed Mallinckrodt tracheal tube with a Murphy's eyes."
15896622|NCT03676374|Drug|Prucalopride|Prucalopride 2mg taken once a day as add-on to PPI (2x/d)
15896623|NCT03676374|Drug|Placebo Oral Tablet|Placebo tablet taken once a day as add-on to PPI (2x/d)
15896624|NCT03676361|Drug|Desmopressin|Subjects will complete a water deprivation test using desmopressin to aid in the determination of maximum tubular concentration capacity before and six months after uni-nephrectomy.
15896627|NCT03676335|Drug|Hypromellose Eye Drops|Hypromellose Eye Drops of 15ml：75mg, 3 times daily, 1-2 drop
15896628|NCT03676322|Drug|M5049|Participants will receive single ascending oral dose of M5049 in Part A. Participants will receive multiple ascending oral dose of M5049 once daily for 14 days or twice daily for 13 days followed by a single dose on Day 14 in the morning in Part B. Participants will receive a single oral dose of M5049 under fed conditions in Part C.
15896629|NCT03676322|Drug|Placebo|Participants will receive placebo matched to M5049.
15896630|NCT03676309|Drug|Nutriceutical Oral Capsule,|nutraceutical 920 mg (Bergamot 450 mg, Gymnema (400 mg, Phaseolamine 30 mg, Olea Europaea 10 mg) twice day , 12 weeks
15896631|NCT03676309|Drug|Placebo Oral Tablet|placebo tablet twice a day twenty minutes before main meals, for 12 weeks,
15896632|NCT03676296|Drug|Puerarin|Puerarin (90.2 mg daily) in granules (as well as excipients) taken orally for 12 weeks
15896633|NCT03676296|Drug|Placebo|Placebo in granules (with the same excipients as the puerarin supplement but without puerarin) taken orally for 12 weeks
15896634|NCT03676283|Other|Web-based psycho-educational support for family caregivers|A website including potentially modifiable topics shown to be associated with preparedness. The topics cover areas such as knowledge about medical issues including symptoms and symptom relief, communication within the couple, how to spend the time before death, being partner or caregiver, planning of the moment of death and considerations of the partner's future, including psychological issues, logistical issues, economy, and the care for children.
15896635|NCT03676270|Other|Phase I|Chemotherapy, ITK, Hormotherapy, Immunotherapy
15896636|NCT03676257|Other|Endocrine therapies|No intervention
15896637|NCT03676244|Device|immediate implant in defected anterior maxillary esthetic zone|"Patients indicated for immediate implant placement with presence of partial or complete loss (type 2 sockets) of labial bone plate.
~Use of GBR (mix of autogenous bone graft and xenograft in combination to absorbable collagen membrane) and healing abutment at the same time of extraction then place implant palatally engaging the side walls of the socket, leaving a buccal gap.
~construct custom two-piece screw retained healing abutment then remove custom healing abutment and fit and place the collagen membrane for GBR , the membrane should cover the defect 2 mm circumferentially and extend to the level of free gingival margin, Place bone graft material buccal to the implant surface ,replace custom healing abutment."
15896638|NCT03676231|Drug|SGM-1019|Active
15896639|NCT03676231|Drug|Placebo|Inactive
15896640|NCT03676218|Other|Elderly cancer patients|No intervention: consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
15896641|NCT03676205|Biological|PRP|Platelet-Rich Plasma
15896642|NCT03676205|Other|Traumeel|Homeophatic Treatment
15896643|NCT03676192|Drug|CT-16|15mg/kg IV of CT-P16 every 3 weeks up to 6 cycles in the induction study period and every 3 weeks until PD occurs in the maintenance study period.
15896644|NCT03676192|Drug|Avastin|15mg/kg IV of Avastin every 3 weeks up to 6 cycles in the induction study period and every 3 weeks until PD occurs in the maintenance study period.
15896645|NCT03676179|Procedure|patella denervation|patella denervation
15896646|NCT03676179|Procedure|patella non-denervation|patella non-denervation
15896647|NCT03676166|Drug|Cannabis|Inhaled cannabis
15896648|NCT03676153|Other|Nurse-provided guidance|Nurse-provided guidance following an integrative medicine treatment program, for patient implementation of self-administered manual therapies, relaxation, lifestyle changes and traditional medicine.
15896649|NCT03676153|Other|Integrative medicine treatment program|Integrative medicine treatment program
15896650|NCT03676140|Drug|Albendazole on Day 1|Albendazole 400 mg oral tablet Single Dose Treatment on D1
15896651|NCT03676140|Drug|Ivermectin on Day 1|Ivermectin 200 µg/kg oral tablet Single Dose Treatment on Day 1
15896652|NCT03676140|Drug|Diethylcarbamazine on day 1|Diethylcarbamazine 6 mg/kg oral tablet Single Dose Treatment on Day 1
15896653|NCT03676140|Drug|Azithromycin on Day 1|Azithromycin 30mg/Kg oral tablet Single Dose Treatment On Day 1
15896654|NCT03676140|Drug|Azithromycin on Day 8|Azithromycin 30mg/Kg oral tablet Single Dose Treatment On Day 8
15896655|NCT03676127|Other|ultrasonographic dermal thickness measurements|ultrasonographic dermal thickness measurements
15896656|NCT03676114|Drug|ketamine|0.5mg/kg intravenous ketamine injection before incision followed by 0.25mg/kg/hr intravenous ketamine infusion during the operation
15896657|NCT03676114|Drug|Normal saline|Same volume of normal saline will be administrated
15896658|NCT03676101|Biological|9-valent HPV Recombinant Vaccine|Subjects received 3 doses of 9-valent HPV vaccine according to a 0, 2, 6-month schedule.
15896659|NCT03676101|Biological|Placebo|Subjects received 3 doses of Placebo according to a 0, 2, 6-month schedule.
15896660|NCT03676088|Procedure|root coverage|recession coverage is treated with modified coronally advanced tunnel with connective tissue graft with recombinant human platelet derived growth factor- BB for Experimental: Test group and without recombinant human platelet derived growth factor- BB for Active Comparator: Control group
15896661|NCT03676062|Other|exercise|All exercises programs applied three sessions per week, totally six week.
15896662|NCT03676049|Drug|Cannabidiol|CBD will be administered as an adjunct to all current antiepileptic drugs. A dosing titration period will start with 100 mg/day, with 50mg BID dosing, and will be titrated monthly as tolerated based on clinical response, up to 300mg/day. This is based on a targeted dosing of 2.5 ---5---7.5 mg/kg/d.
15896663|NCT03676036|Drug|DS107E|
15896664|NCT03676036|Drug|Vehicle|
15896665|NCT03676023|Drug|Tranexamic Acid|Inhalation of Transexamic acid in age adjusted dosing
15896666|NCT03676010|Other|Sarcoma and GIST|No Intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
15896667|NCT03676010|Other|Breast cancer|No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
15896668|NCT03676010|Other|Pancreatic cancer|No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
15896719|NCT03675633|Diagnostic Test|FEUrea|FEUrea in decompansated liver cirrhosis
15917429|NCT03516734|Other|Usual Intake|No lentils will be provided.
15896669|NCT03676010|Other|Renal cell carcinoma|No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy.
15896670|NCT03676010|Other|Colon cancer|No intervention : Consensus of international experts to provide definition of survival endpoints to be used in randomized controlled trials to assess treatment efficacy (adjuvant setting).
15896671|NCT03675997|Other|HAD (Hospital Anxiety and Depression) scale|HAD (Hospital Anxiety and Depression) scale will be completed and reported by patients the first day of conditioning and then weekly from day 0 corresponding to the autograft, until their last day in the hematological department.
15896672|NCT03675984|Behavioral|asymmetrical stabilization exercise|Exercise is combined to form an appropriate combination of motion (Side-lying, Bird-dog, Prone arm lift, Prone leg lift) according to the curve pattern and muscle weakness of each patient's.
15896673|NCT03675971|Drug|Cannabinol|Postoperative pain treatment
15896674|NCT03675971|Drug|Placebo oral capsule|Placebo comparator
15896675|NCT03675958|Other|Johnstone's Pressure Splint|the intervention consists in the application of two tools used for the treatment of spasticity post - CVD. Johnstone's Pressure Splint added Stretching
15896676|NCT03675958|Other|Stretching|the intervention consists in the application of one tool used for the treatment of spasticity post - CVD. Just Stretching
15896677|NCT03675932|Other|Rapid Cadence Cycling on a Solo-Rider Spin Bicycle|Individuals with Parkinson's Disease will participate in 60 minute spin-classes during which they will follow the Pedaling for Parkinson's(TM) Foundation recommended protocol to achieve a cadence of 80-90 during the 40 minute main set.
15896678|NCT03675919|Device|Scale|self-monitoring of body weight; with automatic data transfer into the personalized and secured online portal
15896679|NCT03675919|Device|Step counter|self-monitoring of physical activity; with automatic data transfer into the personalized and secured online portal
15896680|NCT03675919|Device|Blood glucose meter with test stripes|self-monitoring of blood glucose; with automatic data transfer into the personalized and secured online portal
15896681|NCT03675919|Other|Access to the online portal|self-monitoring of health parameters
15896682|NCT03675919|Other|Telemedical coaching|regular telephone calls providing information about T2DM, healthy lifestyle, low-carbohydrate diet and physical activity
15896683|NCT03675906|Other|hypoalbuminemia|hypoalbuminemia and acute kidney injury
15896684|NCT03675893|Drug|Letrozole|Letrozole is a hormonal therapy that works by lowering the production of estrogen in the body.
15896685|NCT03675893|Drug|Abemaciclib|Abemaciclib is a cyclin-dependent kinase (CDK) inhibitor.
15896686|NCT03675880|Drug|TAB014|TAB014 of 1.25mg(0.05ml)、2.00mg(0.08ml)、2.50mg(0.10ml)
15896687|NCT03675867|Other|Correlation between resting respiratory parameters and cardio-respiratory parameters at exercise|Correlation between resting respiratory parameters and cardio-respiratory parameters at exercise
15896688|NCT03675854|Drug|Cefazolin|3 weeks
15896689|NCT03675841|Drug|Pazufloxacin Mesilate ear drops|Pazufloxacin Mesilate ear drops of 0.1%，0.3%，0.5%
15896690|NCT03675828|Behavioral|Virtual Visit|The Cleveland Clinic Express Care Online application will be used in this intervention. The subjects will have a virtual consult with a clinician from the study team that will mirror an experience had at an outpatient post-discharge visit, including review of systems and medications.
15896691|NCT03675815|Drug|Darunavir (DRV) 800 milligram (MG) Oral Tablet|800 milligrams (mg) orally once daily for 96 weeks
15896692|NCT03675815|Drug|Ritonavir 100 MG Oral Tablet|100 mg orally once daily for 96 weeks
15896693|NCT03675815|Drug|N(t)RTIs|Choice of N(t)RTIs determined by clinician guided by either genotypic resistance testing or use of a protocol-specified algorithm for N(t)RTI selection
15896694|NCT03675815|Drug|Dolutegravir 50 MG Oral Tablet|50 mg orally once daily for 96 weeks
15896695|NCT03675815|Drug|TDF 300 MG Oral Tablet|300 mg orally once daily for 96 weeks
15896696|NCT03675815|Drug|3TC 300 MG Oral Tablet|300 mg orally once daily for 96 weeks. Choice of 3TC or FTC will be determined by clinician
15896697|NCT03675815|Drug|FTC 200 MG Oral Cap|200 mg orally once daily for 96 weeks. Choice of emtricitabine or lamivudine will be determined by clinician
15896698|NCT03675802|Drug|misoprostol|giving misoprostol to this group
15896699|NCT03675802|Drug|dinoprostone|giving dinoprostine
15896700|NCT03675776|Drug|Rapastinel|Rapastinel (prefilled syringe, weekly intravenous IV administration).
15896701|NCT03675776|Drug|Placebo|Placebo (prefilled syringe, weekly IV administration).
15896702|NCT03675763|Other|Manual treatment|Craniosacral therapy protocol.
15896703|NCT03675737|Biological|Pembrolizumab|Administered as an IV infusion on Day 1 Q3W
15896704|NCT03675737|Drug|Cisplatin|Administered as an IV infusion on Day 1 Q3W
15896705|NCT03675737|Drug|5-fluorouracil|Administered as a continuous IV infusion on Days 1-5 Q3W
15896706|NCT03675737|Drug|oxaliplatin|Administered as an IV infusion on Day 1 Q3W
15896707|NCT03675737|Drug|capecitabine|Administered orally BID on Days 1 to 14 Q3W
15896708|NCT03675737|Drug|Placebo for Pembrolizumab|Administered as an IV infusion on Day 1 Q3W
15896709|NCT03675724|Dietary Supplement|Fisetin|Flavonoid Family
15896710|NCT03675724|Drug|Placebo oral capsule|Placebo
15896711|NCT03675711|Device|Midline|Patient will receive a Midline catheter within 48h after disappearance of indication for CVC
15896712|NCT03675711|Device|PVC|Patient will receive a standard PVC within 48h after disappearance of indication for CVC
15896713|NCT03675698|Other|Nasotracheal Intubation|side of nostril and size of endotracheal tube estimation for nasotracheal intubation will be done based on radiological imaging ( CT/MRI head)
15896714|NCT03675685|Biological|CCH (collagenase clostridium histolyticum)|A single dose of 3.36 mg of CCH will be administered as subcutaneous injections (CCH 0.84 mg) per quadrant concurrently in 4 quadrants. A quadrant is defined as one of the following: left buttock, right buttock, left posterolateral thigh, or right posterolateral thigh.
15896715|NCT03675672|Drug|Misoprostol Oral Tablet|Misoprostol 200mcg
15896716|NCT03675672|Drug|Placebo Oral Tablet|Placebo Tablet
15896717|NCT03675659|Drug|intra-articular injection|intra-articular injection with magnesium sulfate with four injections at weekly intervals
15896718|NCT03675646|Drug|Morphine|Intrathecal injection of 250 mcg preservative-free morphine before surgery
15896720|NCT03675620|Device|BFR|Delfi's Personalized Tourniquet System for Blood Flow Restriction will be used with leg extension and leg press exercises. Bilateral thigh cuffs will be applied to the participants and occlusion pressure will be set at 80% of total occlusive pressure as determined by the Doppler sensor. Each participant will perform 4 sets of each exercise (1 set of 30 repetitions followed by 3 sets of 15 repetitions) with resistance of 30% 1-repetition maximum. The pressure will remain through completion of the final set, but not to exceed 5 minutes. One minute rest without tourniquet application will be performed between exercises. Sets and repetitions will remain constant for each participant; however, resistance will be incrementally increased.
15896721|NCT03675620|Other|Standard Rehabilitation|The control group will perform perform 4 sets of leg extensions and leg press (1 set of 30 repetitions followed by 3 sets of 15 repetitions) with resistance of 30% 1-repetition maximum. Sets and repetitions will remain constant for each participant; however, resistance will be incrementally increased.
15896722|NCT03675607|Other|Complementary feeding behaviours|Any kind of complementary feeding practice
15896723|NCT03675594|Device|CAD/CAM titanium denture base|metallic denture base made of titanium
15896724|NCT03675594|Device|CAD/CAM cobalt/chromium denture bases|metallic denture bases made of cobalt/chromium
15896725|NCT03675581|Drug|Microgynon|fixed sequence trial
15896726|NCT03675581|Drug|Nintedanib|fixed sequence trial
15896727|NCT03675568|Procedure|Non-cultured keratinocyte suspension|A new method for treatment of burn wounds
15896728|NCT03675568|Procedure|Split skin Graft|A traditional method for treatment of burn wounds
15896729|NCT03675555|Drug|Mirtazapine|Each patient received 30 mg Mirta tablet orally with sips of water and 100 ml 0.9% sodium chloride (normal saline [NS]) (IVI) over 15 minutes as a placebo for Dex solution 2 hours preoperatively.
15896730|NCT03675555|Drug|Dexamethasone phosphate|Each patient received a placebo tablet identical to Mirta tablet orally with sips of water and Dex 8 mg ampoule diluted in 100 ml 0.9% NS IVI over 15 minutes, 2 hours preoperatively.
15896731|NCT03675555|Drug|Placebo|Each patient received a placebo tablet identical to Mirta tablet orally with sips of water and 100 ml 0.9% NS IVI over 15 minutes as a placebo for Dex solution 2 h preoperatively.preoperatively.
15896732|NCT03675542|Drug|CUDC-305|Dose-selection treatment with HSP90 inhibitor (CUDU-305)
15896733|NCT03675529|Behavioral|High Intensity Interval Training bout|Patients randomized to the HIIT bout will perform one single supervised High Intensity Interval Training bout consisting firstly of a wattmax test on a stationary bike, in order to set the training intensity. This is followed by 10 minutes at low intensity at approximately 30% of wattmax. Subsequently patients will perform 16 min with 4 cycles with High and Low intensity. HI intervals consisting of 1 min with 100% of wattmax followed by 3 min recovery with the intensity load of 30% of wattmax.
15896734|NCT03675516|Other|No specific intervention|Usual care
15896735|NCT03675503|Other|Fall Prevention Decision Support|Decision support used by nurses to appropriately provide ambulatory aids to hospitalized patients in order to reduce hospital falls
15896736|NCT03675490|Behavioral|ABLE - exercise with interactive technology|Multicomponent exercise with interactive technology - consists of wearable sensors and a screen displaying interaction. When the person does the exercises it produces an arts-based response on the screen (e.g., digital painting).,
15896737|NCT03675477|Drug|SHR0302|The study drug, SHR0302, is designed to block the activity of an enzyme protein called JAK (known as a JAK inhibitor).
15896738|NCT03675477|Drug|Placebos|Placebo Oral Tablet
15896739|NCT03675451|Drug|89ZR-DF-IAB2M|injection of 10 milligrams of radioactive 89Zr-Df-IAB2M followed by PET/CT scan
15896740|NCT03675451|Drug|68Ga-PSMA-HBED-CC|Optional but recommended 68Ga-PSMA-HBED-CC (5±2mCi) injection and PET/CT scan (1 to 3 hours after the injection) will also be performed prior to radical prostatectomy depending on subject's availability and compliance.
15896741|NCT03675438|Other|Sub-epitheilal TCA Inlay|A TCA lenticule is placed at the sub-epithelial interface with the anterior surface of Bowmans layer
15896742|NCT03675425|Other|Group 1: non chest shielding|non chest childin: infants will be randomized into two different phototherapy groups eco with pad diameter will be measured in before and after phototherapy,
15896743|NCT03675425|Other|Group 2: chest shielding|chest childing: infants will be randomized into two different phototherapy groups eco with pad diameter will be measured in before and after phototherapy,
15896744|NCT03675412|Dietary Supplement|Caffeine tablet|Each eligible participant will receive one 200 mg caffeine tablet to ingest after completing all baseline study tasks.
15896745|NCT03675399|Other|Supra-threshold isometric exercise|The supra-threshold intensity will be stablished at 120% of participant's PFIS pre-session measurement (20% above the individual's pain threshold).
15896746|NCT03675399|Other|Infra-threshold isometric exercise|The infra-threshold intensity will be stablished at 80% of participant's PFIS pre-session measurement (20% bellow the individual's pain threshold).
15896747|NCT03675386|Other|Interventional Group|The Transitional Pain Service Program enables targeted, mechanism-based, treatment innovations aimed at reducing the incidence and severity of chronic post-surgical pain, disability and enabling safe opioid prescribing/ weaning after major surgery. The investigator's TPSP intervention uses a variety of methods to support patients to manage pain and wean off opioids. This includes physician-guided opioid and non-opioid pharmacotherapy and tapering, and clinical psychology services specializing in pain education, Acceptance & Commitment Therapy (ACT) and e-mobile self-management tools.
15896748|NCT03675386|Other|Control Intervention|Patients in the control group will receive standard care, which involves standard postoperative follow-up with their surgeon/primary care provider. Patients will also be sent with a link for an online multimedia tool during each follow-up time point that will provide information and education regarding non-pharmacologic techniques for managing pain. At the end, all patients in the control arm will be invited to join the TPSP after one year of follow-up if they are still taking opioids.
15896749|NCT03675373|Behavioral|Mobile chat-based instant messages|"Subjects in the active arm study will receive continuous interactive chat-based intervention as an extension of alcohol brief intervention at baseline. The interactive mobile chat will be carried out on Friday night and Saturday before and during the period of happy hour and ask for drinking and giving personalized advises on drinking reduction using behavioral change techniques."
15896822|NCT03674762|Device|Microgrooved dental implants|Dental Implant placement
15896750|NCT03675373|Behavioral|Alcohol brief intervention|Those in the control arm will be assigned to only receive the face-to-face ABI. The ABI consists of: (1) giving feedback and information about the screening result in phase I and hazard of drinking; (2) emphasizing the benefits of reduce drinking and informing about alcohol problems; (3) setting goal on reducing alcohol consumption; (4) reviewing advice and ;(5) giving encouragement.
15896751|NCT03675360|Behavioral|Low-Carbohydrate Diet|"Behavioral modification to reduce carbohydrate consumption. Target <40 g net carbohydrates per day for first 3 months; <60 g net carbohydrates per day for months 4 onwards. The intervention will consist of 4 weekly individual counseling sessions, followed by 4 group sessions held every other week, with phone follow-ups in between group sessions. For the last 3 months of the study, there will be 3 monthly group sessions and 3 telephone follow-ups.
~At baseline, participants will receive written information with standard physical activity recommendations."
15896752|NCT03675347|Other|angioplasty|angioplasty
15896753|NCT03675334|Procedure|Root coverage with collagen matrix graft|at one side, the root coverage have been done with a extended flap technique and collagen matrix graft. At the other side, the same technique was performed with connective graft.
15896754|NCT03675334|Procedure|Root coverage with subepithelial connective tissue graft|at one side, the root coverage have been done with a extended flap technique and collagen matrix graft. At the other side, the same technique was performed with connective graft.
15896755|NCT03675334|Other|Basic periodontal treatment|profilaxis, coronary polishing and scaling and root planning
15896756|NCT03675321|Device|Active Auricular Neurostimulation|Active auricular neurostimulation for 4 weeks. Subjects in Active group who do not have significant improvement after 4 weeks may receive an additional 4 weeks of active neurostimulation therapy.
15896757|NCT03675321|Device|Sham Auricular Neurostimulation|"Sham auricular neurostimulation for 4 weeks with identical device as the active but lacking the electrical charge.
~Subjects in Sham group who do not have significant improvement after 4 weeks may receive an additional 4 weeks of active neurostimulation therapy."
15896758|NCT03675308|Biological|placebo for rizankizumab|Placebo for risankizumab administered by subcutaneous (SC) injection
15896759|NCT03675308|Biological|risankizumab|Risankizumab administered by subcutaneous (SC) injection
15896760|NCT03675295|Drug|Hyalase|injection of Hyalase + 10 cc saline injection nearby median nerve as hydro-dissection
15896761|NCT03675295|Drug|Saline|injection of 10 cc saline injection nearby median nerve as hydro-dissection
15896762|NCT03675282|Drug|(11C)PE2I|Subjects will received (11C)PE2I PET Scans at Baseline and 24 Month Visits
15896763|NCT03675269|Other|HBOT|Standard practice
15896764|NCT03675269|Behavioral|Standard wound care|Standard wound care
15896765|NCT03675256|Biological|immediate Gardasil 9, delayed MenVeo vaccine|Intervention is immediate administration of 9-valent HPV vaccine and delayed MenVeo vaccine
15896766|NCT03675256|Biological|immediate MenVeo vaccine, delayed Gardasil 9|Intervention is immediate administration of MenVeo vaccine and delayed administration of Gardasil 9
15896767|NCT03675256|Biological|immediate Cervarix, delayed MenVeo vaccine|Intervention is immediate administration of bivalent HPV vaccine and delayed MenVeo vaccine
15896768|NCT03675243|Diagnostic Test|sphincterometry|Sphincterometry is a method of the spincter function examination, which allows to assess the state of the anal sphincter muscle and its function
15896769|NCT03675230|Device|Tomotherapy HD|Patients with Medulloblastoma receiving Tomotherapy
15896770|NCT03675230|Device|3DCRT|Patients with Medulloblastoma receiving Three-Dimensional Conformal Radiation Therapy
15896771|NCT03675217|Other|PE|Physical exercise program for familiy caregivers. 36 session physical exercise (3 sessions/week) performed by physioterapist. It incluided exercices to improve coordination, aerobic capacity, control motor and strenght
15896772|NCT03675217|Other|Usual Care|Usual Programe in primary care for family caregivers. 4 session (2 session/week). It incluides: ergonomy, postural hygiene, mobilitation of patients and self-care.
15896773|NCT03675204|Other|No intervention|No intervention
15896774|NCT03675191|Drug|Orlistat 120Mg Cap|Drug,Orlistat 120Mg Cap, three times a day, within 1hour after meal
15896775|NCT03675191|Drug|Phentermine Pill|Drug,Phentermine Pill 37.5mg, both in two arms, one time a day, within 1hour after meal
15896776|NCT03675178|Drug|Anerning particle|Anerning particle ,1 bag/time,3 times/ day, +ceftriaxone sodium,50mg/kg/time, 1 time/day, the total amount per day does not exceed 2g，for 10 days.When the condition is cured, stop the medicine at any time.
15896777|NCT03675178|Drug|control group|Anerning particle placebo ,1 bag/time,3 times/ day, +ceftriaxone sodium,50mg/kg/time, 1 time/day, the total amount per day does not exceed 2g，for 10 days.When the condition is cured, stop the medicine at any time.
15896778|NCT03675165|Behavioral|Best Possible Self|A writing exercise developed in 2001 by Laura King. The frequency of engagement with the exercise is down to the user's discretion though we recommend to them to write things down once every week for the duration of the study.
15896779|NCT03675152|Other|Soft spinal brace|Soft thoracolumbar brace worn 23 hours a day.
15896780|NCT03675152|Other|thoracolumbar orthosis|Hard thoracolumbar orthosis done individually molded, Worn 23 hours a day.
15896781|NCT03675152|Other|Excersice restriction|Patients are only allowed to do isometrical excersices adviced by a physiotherapist.
15896782|NCT03675139|Drug|Medroxyprogesterone Acetate|At a dosage of 10mg/day
15896783|NCT03675139|Drug|Dydrogesterone 10 MG|At a dosage of 20 mg/day
15896784|NCT03675126|Drug|SRP-5051|SRP-5051 administered as an IV infusion.
15896785|NCT03675113|Other|Upper extremity aerobic exercise|"Range of maximal heart rate will be followed by a polar band during supervised session each week.
~Aerobic exercise will be trained for 30 min-per/day, 3 days/week, 6 weeks. All sessions are being performed by a physiotherapist at cardiopulmonary rehabilitation department."
15896786|NCT03675113|Other|Control Group|Deep breathing exercises combinated with arm movements
15896787|NCT03675100|Procedure|colonoscopic mucosal biopsy|colonoscopic mucosal biopsy was undertaken for every participant
15896788|NCT03675074|Device|Neujia|Neujia devices endoscopically deployed for jejunoileal compression anastomosis
15896789|NCT03675061|Other|Current care|Tocolysis and a complete corticosteroid treatment.
15896823|NCT03674749|Other|Meditation and Hyperbaric Oxygen Treament|Meditation sessions will be combined with hyperbaric oxygen treatment
15896790|NCT03675061|Device|PartoSure Test negative|Biochemical test and nifedipine tocolysis, then return at home with the midwife's visit at home twice a week up to 34 weeks of amenorrhea .
15896791|NCT03675061|Device|PartoSure Test positive|Biochemical test and tocolysis and a complete corticosteroid treatment. then if situation is stable, return at home with the midwife's visit at home twice a week up to 34 weeks of amenorrhea
15896792|NCT03675048|Dietary Supplement|BioGaia Protectis drops|food supplement containing the patented lactic acid bacterium Lactobacillus reuteri Protectis®/™ (L. reuteri DSM 17938).
15896793|NCT03675048|Dietary Supplement|Placebo|Contains same excipients as study drug, without the active ingredient L. Reuteri.
15896794|NCT03675035|Device|Endomina|Reduction of the gastro-jejunal anastomosis through sutures
15896795|NCT03675022|Drug|Dupilumab|The investigational drug is dupilumab, 300mg in 2ml solution for subcutaneous application. All Patients will receive dupilumab, 300mg, every two weeks (8 subcutaneous injections total).
15896796|NCT03675009|Other|Educational Programming|Green Cleaning educational programming to day care staff.
15896797|NCT03674996|Other|Same day discharge|Discharge of the patient 12 hours after the minimally invasive radical prostatectomy - experimental group
15896798|NCT03674996|Other|Next-day discharge|Discharge of the patient 24 hours after the minimally invasive radical prostatectomy - experimental group
15896799|NCT03674996|Other|2-days discharge|Discharge of the patient 24 hours after the minimally invasive radical prostatectomy - control group
15896800|NCT03674983|Behavioral|Conditional Economic Incentive (CEI)|"If hair testing shows that a participant has taken PrEP pills about 5-7 times in the previous week, he will receive a grade A; if he has taken PrEP pills about 3-4 times in the previous week he will receive a grade B; and if he has taken PrEP pills only 2 times or less, he will receive a grade C. For those in the CEI group, if participant gets an A, he receives two additional prizes; if he gets a B, he receives one additional prize; and if he gets a C, he receives no additional prizes."
15896801|NCT03674970|Drug|Nicotine Film|"Three doses of nicotine films will be used in this project: 0 mg, 2 mg, and 4 mg.
~The active pharmaceutical ingredient in the nicotine film product is nicotine polacrilex (20%, USP). The film has a muco-adhesive property and allows nicotine to be absorbed through the oral mucosa. After placement in the oral cavity, the nicotine film dissolves in less than five minutes. The film is in the form of 1 inch x 1 inch square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting."
15896802|NCT03674944|Behavioral|Behavioral Weight Loss (BWL) + Emotion Regulation (ER)|The BWL + ER program will teach Dialectical Behavior Therapy (DBT) skills (dialectical abstinence, emotion regulation skills, mindfulness, and distress tolerance) to the adolescent and parent group sessions. Parents are expected to model skill usage and DBT language with their teen to reinforce the skills at home. Adolescents and parents will track emotions and DBT skills used in diary cards which will be provided. Emotion-Focused Parent Training (EFPT) will be provided to the parents at each session to train the parent to support the adolescent in processing emotions, increasing parental emotion self-efficacy, promoting positive parent-adolescent relationships, and reducing the need for dysfunctional emotion regulation behaviors.Behavior coaching will be provided to the adolescent and parent to encourage compliance and review skills after each session (DBT or BWL).
15896803|NCT03674944|Behavioral|Behavioral Weight Loss (BWL)|All participants will be instructed to consume an energy restricted diet based on initial body weight. Participants will be instructed to record and self-monitor their food intake. The physical activity component will focus on increasing both lifestyle activity and structured exercise programs. Behavior change recommendations will include: self-monitoring, goal setting, managing high-risk situations, and relapse prevention. Parenting skills will be discussed during parent group sessions which will encourage parents to adopt authoritative parenting styles with regard to eating and exercise behaviors. Parents will also learn about behavioral modification principles, including modeling, reinforcement, and operant conditioning. Behavior coaching will be provided to the adolescent and parent after each session to encourage compliance, discuss completed homework, review habit books to praise efforts and give feedback for areas of improvement.
15896804|NCT03674931|Behavioral|musical practice|Intensive weekly musical keyboard training over 12 months
15896805|NCT03674931|Behavioral|music education|Recreative weekly musical courses without practice over 12 months
15896806|NCT03674918|Diagnostic Test|24 h ambulatory blood pressure measurements|24 h ambulatory blood pressure measurements : an ambulatory 24 h blood pressure device that automatically measures blood pressure every 15 minutes is given to the patient for 24 h
15896807|NCT03674905|Procedure|Intra-articular injection|Intra-articular injection at the completion of TAA procedure.
15896808|NCT03674905|Procedure|Peripheral nerve block|Pre-operative peripheral nerve block.
15896809|NCT03674892|Device|TrueTear™ intranasal neurostimulator (ITN)|Subject will place the tips of the ITN into both nostrils simultaneously. Subject will be asked to apply it for 3 minutes [could be modified if need be], daily.
15896810|NCT03674879|Other|Text Message|Patient contact attempted with text message.
15896811|NCT03674866|Drug|Insulin degludec|Participants are treated with Tresiba® (insulin degludec) under conditions of routine care.
15896812|NCT03674853|Drug|Wuling Capsule|take Wuling Capsule in experiment group for 2 months
15896813|NCT03674853|Drug|Oryzanol|take oryzanol in active comparator group for 2 months
15896814|NCT03674840|Procedure|angle kappa based SBL-3 implantation|SBL-3 implantation based on kappa angle guided by Callisto Eye System(Carl Zeiss Meditec, Germany) intraoperatively.
15896815|NCT03674840|Procedure|0 to 180 degree SBL-3 implantation|SBL-3 implantation in the direction of 0 to 180 degree guided by Callisto Eye System(Carl Zeiss Meditec, Germany) intraoperatively.
15896816|NCT03674827|Biological|PF-06936308|PF-06936308 components will be administered 4 times per cycle. A cycle is 4 months.
15896817|NCT03674827|Biological|PF-06936308|PF-06936308 components will be administered 4 times per cycle. A cycle is 4 months.
15896818|NCT03674814|Drug|Enzalutamide|Enzalutamide will be taken by mouth at assigned dose. Enzalutamide will be obtained as standard of care prescription (not provided by study).
15896819|NCT03674814|Drug|Relacorilant|Relacorilant will be taken by mouth at assigned dose. Relacorilant will be provided by the study.
15896820|NCT03674788|Device|Transcatheter valve intervention|
15896821|NCT03674775|Other|DART QI Program Participation|Antibiotic prescribing data will be collected at multiple time points both before and after the initiation of the intervention.
15896825|NCT03674723|Other|Dietary Intakes|Four levels of methionine intakes will be provided by the reference protein drinks, 3 levels of methionine from Mung beans and 3 levels from Mung beans with rice or wheat.
15896826|NCT03674710|Procedure|Standard suction, slow-pull, wet suction|"Patients will be sampled for a total of 3 consecutive FNA passes with a sequential method of standard suction, slow-pull, and wet suction. After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence."
15896827|NCT03674710|Procedure|Standard suction, wet suction, slow-pull|"Patients will be sampled for a total of 3 consecutive FNA passes with a sequential method of standard suction, wet suction, and slow-pull. After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence."
15896828|NCT03674710|Procedure|Slow-pull, standard suction, wet suction|"Patients will be sampled for a total of 3 consecutive FNA passes with a sequential method of slow-pull, standard suction, and wet suction. After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence."
15896829|NCT03674710|Procedure|Slow-pull, wet suction, standard suction|"Patients will be sampled for a total of 3 consecutive FNA passes with a sequential method of slow-pull, wet suction, and standard suction. After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence."
15896830|NCT03674710|Procedure|Wet suction, standard suction, slow-pull|"Patients will be sampled for a total of 3 consecutive FNA passes with a sequential method of wet suction, standard suction, and slow-pull. After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence."
15896831|NCT03674710|Procedure|Wet suction, slow-pull, standard suction|"Patients will be sampled for a total of 3 consecutive FNA passes with a sequential method of wet suction, slow-pull, and standard suction. After completing all the passes, the obtained specimen will be packed individually and sent to pathologists who are blind to the method sequence."
15896832|NCT03674697|Device|Green LED vs White LED light therapy|You will be asked to locate a dark room in your house three weeks prior to your surgery. You will place the provided LED strip near you on a flat surface and turn it on for 2 hours a day until the day of the surgery. You have the freedom to pick anytime during day or night to use the light. We will ask you to be as consistent as possible with the time you chose. You can engage in any activity to pass the time as long as it does not involve exposure to another light from an outside source (computers, TV, smart phones, tablets, etc…).
15896833|NCT03674684|Other|hydroxyethyl starch|After induction to anaesthesia patients received either hydroxyethyl starch or gelatin or crystalloids
15896834|NCT03674671|Drug|Intravenous Ketamine|Participants will receive 0.5mg/kg IV over 40 minutes, thrice weekly for 3 or 4 weeks. If participant responds, they will receive infusions weekly for one month, once every two weeks for two months, and once every month for three months. Should participant relapse during once monthly dosing, they may return to dosing once every two weeks for the remainder of the study.
15896835|NCT03674671|Procedure|Electroconvulsive Therapy|Participants will receive ECT treatment thrice weekly for the 3 or 4 weeks. If participant responds, they will continue to receive ECT, with frequency at the discretion of the treating physician based on best practice guidelines for the remainder of the study.
15896836|NCT03674658|Drug|Propafenone|oral, TID
15896837|NCT03674645|Device|MRI acquisitions|Procedure of the study is an MRI exam without any injection or invasive procedure, that will be performed on the Siemens Magnetom Aera imager of Liryc institute (L'Institut de RYthmologie et modélisation Cardiaque) (Xavier Arnozan site - Bordeaux)
15896838|NCT03674632|Behavioral|Relaxation meditation tape|The tape used in this study is based on a meditation CD designed for breastfeeding mother (Menelli, 2004). The recording will be transcribed and translated into Chinese language by a certified yoga therapist.
15896839|NCT03674619|Procedure|Anterior discectomy|Anterior discectomy will be performed and a microscope is used. After separation of the platysma muscle the pre-vertebral space is reached by an approach medial to the sternocleido-mastoid muscle and the carotid artery and lateral to the trachea and oesophagus. Then the disc is incided and the corpora are distracted to perform discectomy. Usually the posterior ligament is cut and the spinal root is decompressed and if necessary the arthritic rims are removed. An inter-vertebral fusion device is inserted, two levels are allowed in the spondylosis study.
15896840|NCT03674619|Behavioral|Conservative treatment|Patients will first attend an experienced specialist in physical medicine and rehabilitation who will answer concerns and questions and if necessary repeat the information given before inclusion. The aim of the brief intervention is to promote better understanding and coping of the condition. The intervention will include supervision by a physiotherapist (6 sessions altogether) and provide advice on how to handle secondary neck muscle pain and dysfunction, reduce eventual fear avoidance, and advice to stay active.
15896841|NCT03674606|Drug|Low dose aspirin|One 75 mg aspirin dose taken daily
15896842|NCT03674593|Procedure|Mitral valve chordae prosthesis|"The method consists of five stages:
~Measure the required length of the chords
~Forming loops
~Fixation of the loop group to the papillary muscles
~Fixation of chordal loops to the free edge of the valve
~Annuloplasty with a support ring and a hydraulic test to confirm the absence of prolapse"
15896843|NCT03674593|Procedure|Mitral valve chordae translocation|"The method consists essentially of three stages:
~Selection of the secondary chord.
~Fixation of secondary chords to the free edge of the valve.
~Annuloplasty support ring and hydraulic test to confirm the absence of prolapse."
15896844|NCT03674580|Behavioral|Follow-up of the suicidal patients|No intervention. Follow-up of the suicidal patients
15896847|NCT03674554|Procedure|titanium bases using intra oral luting cement technique|a full-arch screw-retained implant prosthesis on titanium bases using intra oral luting cement technique
15896848|NCT03674554|Procedure|transmucosal abutment|a full-arch screw-retained implant prosthesis with transmucosal abutment
15896849|NCT03674541|Drug|Pyridostigmine Bromide|Pyridostigmine Bromide 60 mg capsule by mouth as a one time dose
15896850|NCT03674541|Drug|Placebo|Placebo (Cellulose microcrystalline) capsule by mouth as a one time dose
15896851|NCT03674528|Other|Magnetic Resonance Elastography (MRE)|The MRE scan will several breath holds and will take approximately 30 minutes to complete.
15896852|NCT03674528|Diagnostic Test|Liver biopsy|Subjects undergoing WLS will be asked to allow for liver biopsy samples to be collected during their surgical procedure. The collection of these samples will take approximately 5 minutes to complete.
15896853|NCT03674515|Device|"Smartphone application placebo"|"Strategy based on smartphone application placebo"
15896854|NCT03674515|Device|"Smartphone equipped with application bouge = Coach group"|"Strategy based on smartphone application bouge"
15896855|NCT03674502|Drug|ADU-1604|anti-CTLA-4 monoclonal antibody
15896856|NCT03674489|Other|Neurodynamic Slider Mobilization|"Subjects will be positioned in supine with the examiner supporting his/her arm and facing caudally. The arm will be taken into the ULNT2a position as described in Butler's text - so as to bias the median nerve. Once passive resistance is felt or a feeling of mild tension is reported in the median nerve field, a series of mobilizations will be performed to slide the nerve proximally and distally in an alternating manner via providing wrist extension with concurrent shoulder girdle elevation and then providing wrist flexion with concurrent shoulder girdle depression. This will be performed for 2 sets of 10 cycles at a rate of 6 seconds per cycle (3 sec in each position) - not moving further into described tension or passive resistance."
15896857|NCT03674489|Other|Neurodynamic Tensioner Mobilization|"Subjects will be positioned in supine with the examiner supporting his/her arm and facing caudally. The arm will be taken into the ULND2a position as described in Butler's text - so as to bias the median nerve. Once passive resistance is felt or a feeling of mild tension is reported in the median nerve field, a series of mobilizations will be performed to tension the nerve in an alternating on/off manner via providing wrist extension with concurrent shoulder girdle depression and then providing wrist flexion with concurrent shoulder girdle elevation. This will be performed for 2 sets of 10 cycles at a rate of 6 seconds per cycle (3 sec in each position) - not moving further into described tension or passive resistance."
15896858|NCT03674489|Other|Sham Neurodynamic Mobilization|Subjects will be positioned in supine with the examiner supporting his/her arm and facing cranially - in a similar position as the UNLD1 test described previously. From here, the therapist will position the patient's arm in 45 deg. of shoulder abduction without scapular depression, 45 deg. of shoulder external rotation, 45 deg. of elbow flexion, and forearm pronation. From this position, a series of sham mobilizations will be performed by passively alternating flexion and extension of the wrist for 2 sets of 10 cycles at a rate of 6 seconds per cycle (3 sec in each position).
15896859|NCT03674476|Drug|BMS-986036|Specified dose on specified days
15896860|NCT03674463|Drug|LCAR-B4822M CAR-T Cell Immunotherapy|Patients will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of CAR-T cells. After a pre-treatment lymphodepletion therapy, patients will receive the LCAR-B4822M CAR-T Cell Immunotherapy by intravenous injection.
15896861|NCT03674450|Behavioral|Heart Rate Variability Biofeedback Training|The study will utilize the Physiolab GP8 heart rate variability and respiration system on a laptop computer used solely for the study with the proper security passwords to protect participant information. The equipment consists of two electrocardiogram sensors (one per wrist) attached by sports wrist bands, a respiration monitoring belt placed around the upper abdomen, two galvanic skin conductance sensors attached to the fingertips, and a thermistor sensor attached to one of the finger tips. Participants will perform a series of monitored breathing exercises.
15896862|NCT03674437|Behavioral|Traditional Neurocognitive Assessments|Traditional Neurocognitive Assessments given with pen and paper
15896863|NCT03674437|Behavioral|Online Cognitive Battery (Cogsuite)|Cognition (Cogsuite) for a battery that consists of seven measurements.
15896864|NCT03674424|Drug|Avelumab|Chemotherapy with or without avelumab followed by surgery
15896865|NCT03674424|Procedure|cystectomy|Cystectomy 3 to 6 weeks after last administration of chemotherapy
15896866|NCT03674424|Combination Product|CG|Chemotherapy 4 cycles of 3 weeks
15896867|NCT03674424|Combination Product|DD-MVAC|Chemotherapy 4 cycles of 2 weeks
15896868|NCT03674424|Combination Product|PG|Chemotherapy 2 cycles of 4 weeks
15896869|NCT03674411|Drug|Fludarabine (FLU)|25 mg/m2 IV over 1 hour (<10 kg: 0.83 mg/kg IV over 1 hour)
15896870|NCT03674411|Drug|Cyclophosphamide (CY)|60 mg/kg IV over 2 hours
15896871|NCT03674411|Drug|Total Body Irradiation (TBI)|165 cGy twice daily
15896872|NCT03674411|Drug|Tacrolimus (Tac)|Tacrolimus will start day -3 and will be administered as a continuous IV infusion at a starting dose of 0.03 mg/kg/day. Goal trough levels will be 10-15 ng/mL for the first 14 days post-transplant and then decreased to a goal of 5-10 ng/ml thereafter.
15896873|NCT03674411|Drug|Mycophenolate Mofetil (MMF)|MMF 3 gram/day IV/PO for adult patients divided in 2 or 3 doses. Pediatric patients will receive MMF at the dose of 15 mg/kg/dose (max 1 gram per dose) every 8 hours beginning day -3.
15896874|NCT03674411|Drug|Granulocyte Colony-Stimulating Factor (G-CSF)|5 ug/kg/d until the absolute neutrophil count (ANC) is >2500/uL for 2 consecutive days
15896875|NCT03674411|Drug|Busulfan (BU)|BU IV once daily with dose based on Pharmacokinetics (PK) calculator over 3 hours
15896876|NCT03674411|Drug|Melphalan|50 mg/m2/day (1.7 mg/kg/day if < 10 kg) IV over 30 min
15896877|NCT03674411|Drug|MGTA 456 Infusion|The target cell dose is >10 x 106 CD34/kg with a maximum TNC 2.7 x 108/kg for children (<18 years) and 8.1 × 108 cells/kg [expanded product only] for adults based on the highest cell dose windows evaluated in prior studies.
15896878|NCT03674398|Behavioral|Exercise+CT|The exercise+CT group is asked to participate in 30 minutes of aerobic exercise followed by a 20-minute cognitive training (CT) program that targets attention and memory. Training will take place following exercise due to elevated levels of brain-derived neurotrophic factor and increased arousal, which is theorized to benefit cognitive task performance. Computerized CT exercises will be delivered using participants' smartphone. Adherence to the computerized CT program is monitored using electronic data upload after each training session. Participants are asked to engage in three sessions per week with the first week taking place in a lab-setting. Participants are asked to continue the aerobic exercise and CT program at home for the subsequent three weeks.
15896916|NCT03674151|Device|Povidone-Iod (PVP-Iod)|Povidone-Iod (PVP-Iod) dressing on split-skin grafted third-degree burn wound
15896917|NCT03674151|Device|Hydrogel|Hydrogel dressing on split-skin grafted third-degree burn wound
15896879|NCT03674398|Behavioral|Exercise only|The exercise only group will receive the same exercise prescription as the exercise+CT group. Participants in this group are asked to watch 20 minutes of health-related educational videos post-exercise. Videos are administered via participants' smartphones. After each video session, participants answer multiple-choice questions that assess engagement. Following the first week of treatment in-lab, participants are asked to continue watching health-related videos, post-exercise, for three weeks at home.
15896880|NCT03674385|Dietary Supplement|vitamin E|Vitamin E is sold as a dietary supplement, either by itself or incorporated into a multivitamin product. it also has anti-oxidant effect
15896881|NCT03674385|Drug|Metformin|Metformin is in the biguanide class. It works by decreasing glucose production by the liver and increasing the insulin sensitivity of body tissues. It is also used in the treatment of polycystic ovary syndrome (PCOS)
15896882|NCT03674385|Drug|Clomiphene Citrate|is a medication used to treat infertility in women who do not ovulate
15896883|NCT03674372|Device|Fetoscopic Endoluminal Tracheal Occlusion (FETO)|This study will position and remove an endoluminal tracheal balloon in utero (FETO) to study the feasibility of implementing FETO therapy in the most severe group of fetuses with left CDH (O/E < 25%; O/E LHR < 30 %) and right CDH (O/E LHR < 45%).
15896884|NCT03674359|Diagnostic Test|BDG analysis|BDG analysis
15896885|NCT03674346|Other|Hypnoanalgesia group|"The running of a hypnosis session is protocolized and is based on three times:
~The hypnotic induction time that allows to move from the state of consciousness to a modified state of consciousness: it will be adapted according to the patient as specified by the procedure of Ericksonian hypnosis. It varies from a few seconds to 10 minutes. Induction time depends on the patient's level of stress, apprehension, subsequent experiences of hospitalization, history, and level of hypnotizability.
~The dissociation time. It is the state of modified consciousness obtained at the end of the induction which is prolonged,
~The time of return. It is time that allows the patient to regain his classic state of consciousness."
15896886|NCT03674346|Other|Meopa Group|"The pain management will be done exclusively by a mask delivering the equimolecular mixture of oxygen and nitrous oxide (MEOPA) throughout the procedure.
~For optimal use, the beginning of its administration by the radiological technologist is performed 3 minutes before the sclerosant injection (at the end of the locating ultrasound). The end of administration will correspond to the end of the injections of the sclerosing product. These sclerosing products are not considered experimental or ancillary products in this study."
15896887|NCT03674333|Dietary Supplement|Folic Acid|Folic acid is a water soluble vitamin, required for various biological functions in human body, including metabolism of homocysteine.
15896888|NCT03674333|Other|Placebo|Placebo - a sugar pill
15896889|NCT03674320|Drug|Testosterone Enanthate|Testosterone Enanthate (25 mg women, 100mg men) will be given via intramuscular injection at study week 2, 3, 6, 7, 10 and 11.
15896890|NCT03674320|Drug|Placebo|Placebo Injection (saline) will be given via intramuscular injection at study week 2, 3, 6, 7, 10 and 11.
15896891|NCT03674307|Other|No screening|No further screening for asymptomatic coronary artery disease after wait-list entry
15896892|NCT03674307|Other|Regular Screening|Annual or second-yearly screening for asymptomatic coronary artery disease after wait-list entry
15896893|NCT03674294|Drug|Aprepitant|Aprepitant is manufactured by Merck & Co. for prevention of acute and delayed chemotherapy-induced nausea and vomiting (CINV) and for prevention of postoperative nausea and vomiting. It was approved by the FDA in 2003
15896894|NCT03674294|Drug|Palonosetron|Palonosetron is a 5-HT3 antagonist used in the prevention and treatment of chemotherapy-induced nausea and vomiting (CINV). It is used for the control of delayed CINV-nausea and vomiting and there are tentative data to suggest that it may be more effective than granisetron.
15896895|NCT03674294|Drug|Dexamethasone|Dexamethasone is a type of corticosteroid medication. It is used in the treatment of many conditions, including rheumatic problems, a number of skin diseases, severe allergies, asthma, chronic obstructive lung disease, croup, brain swelling, and along with antibiotics in tuberculosis.
15896896|NCT03674294|Drug|Placebo Oral Tablet|In the current clinical trial, placebo oral tablet is provided as a substance for Aprepitant with no active therapeutic effect.
15896897|NCT03674281|Device|SAP|Subjects will wear their own personal insulin pump and will wear the study CGM (Dexcom G6).
15896898|NCT03674281|Device|CLC|The Tandem t:slim X2 is an insulin pump with software (Control-IQ Technology) that helps regulate blood glucose more optimally, based on data received from the Dexcom G6 CGM.
15896899|NCT03674268|Diagnostic Test|Management of the Contraversive Pushing Scale|Scale of evaluation of trunk control and pushing behavior in patients with stroke.
15896900|NCT03674242|Drug|eryaspase (L-asparaginase encapsulated in red blood cells)|IV infusion 100 U/kg
15896901|NCT03674242|Drug|Gemcitabine|IV infusion 1000 mg/m2
15896902|NCT03674242|Drug|Carboplatin|IV infusion AUC2
15896903|NCT03674229|Other|Informational Intervention|Receive information about weight management programs
15896904|NCT03674229|Other|Questionnaire Administration|Ancillary studies
15896905|NCT03674229|Behavioral|Telephone-Based Intervention|Receive phone calls from an assigned patient navigator
15896906|NCT03674203|Biological|Platelet-Rich Plasma|1 ml of PRP was distributed in the papillary dermis of the face, repeating the dose at 15 and 30 days.
15896907|NCT03674190|Procedure|Anterior Lumbar Interbody Fusion|Anterior Lumbar Fusion(ALIF)
15896908|NCT03674190|Procedure|Total Disc Replacement|Total Disc Replacement
15896909|NCT03674177|Biological|GSK3888550A RSV Maternal vaccine formulation 1|Single dose administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm
15896910|NCT03674177|Biological|GSK3888550A RSV Maternal vaccine formulation 2|Single dose administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm
15896911|NCT03674177|Biological|GSK3888550A RSV Maternal vaccine formulation 3|Single dose administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm
15896912|NCT03674177|Drug|Placebo (Normal Saline)|Single dose administered intramuscularly at Day 1 in the deltoid region of the non-dominant arm
15896913|NCT03674164|Other|Ovarian Cryopreservation|Surgical ovarian removal and vitrification
15896914|NCT03674151|Device|Silver Nylon dressing|Non-staining Silver Nylon dressing with a permanently plated metallic surface on split-skin grafted third-degree burn wound
15896915|NCT03674151|Device|Manuka-Honey|Manuka-Honey dressing on split-skin grafted third-degree burn wound
15896918|NCT03674138|Diagnostic Test|DNA-guided choice of therapy|Buccal swab for DNA genotyping to identify best antidepressant therapy
15896919|NCT03674138|Other|Clinical management|Clinical management to identify best antidepressant therapy
15896920|NCT03674125|Biological|GLS-6150|Group 1: GLS-6150 2.0 mg at 0, 4, 12, and 24 weeks (N=8, healthy volunteers); Group 2: GLS-6150 1.0 mg at 0, 4, 12, and 24 weeks (N=8, previously treated for HCV infection); Group 3: GLS-6150 2.0 mg at 0, 4, 12, and 24 weeks (N=8, previously treated for HCV infection); Group 4: GLS-6150 2.0 mg at 0, 8, and 24 weeks (N=8, previously treated for HCV infection)
15896921|NCT03674112|Drug|Pertuzumab and Trastuzumab Fixed-Dose Combination for Subcutaneous Administration (PH FDC SC)|PH FDC SC will be administered subcutaneously (SC) at a fixed non-weight-based dose. A loading dose of 1200 mg pertuzumab and 600 mg trastuzumab is then followed by a maintenance dose of 600 mg pertuzumab and 600 mg trastuzumab once every 3 weeks (Q3W).
15896922|NCT03674112|Drug|Pertuzumab IV|Pertuzumab will be administered intravenously (IV) as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose Q3W.
15896923|NCT03674112|Drug|Trastuzumab IV|Trastuzumab will be administered intravenously (IV) as an 8-mg/kg IV loading dose and then 6 mg/kg IV maintenance dose Q3W.
15896924|NCT03674099|Drug|Imatinib Mesylate|Tablets 400 mg
15896925|NCT03674099|Drug|Methylprednisolone|1 g tablets or infusion
15896926|NCT03674086|Device|eAdjust 0.2 hearing aid smartphone application (or app)|The app connects to the Audeo B-90 Direct hearing aids via Bluetooth. The intended use for the app to enable hearing aid users to fine-tune their hearing aids. The app contains a series of sound modifiers, factory presets, sound modifier presets.
15896927|NCT03674073|Biological|Neoantigen Vaccines|HCC (3cm≤D ≤5 cm, fewer than three tumors) patients were treated with Microwave Ablation and 7 courses of neoantigen-based DC vaccines.The first neoantigen-based DC vaccine injection will take place up to 30 days following the completion of Microwave Ablation. The day of the first vaccine injection will be referred to as Day 1.The schedule of vaccination is Day 1, Day 8, Day 15, Day 22, Day 50, Day78, Day106.
15896928|NCT03674073|Procedure|Microwave Ablation|ALL the HCC patients will be treated by Microwave Ablation.
15896929|NCT03674060|Drug|SYO-1644|"100mg: SYO-1644 tablet, PO, 1 100mg tablet
~150mg: SYO-1644 tablet, PO, 1 100mg tablet and 1 50mg tablet
~200mg: SYO-1644 tablet, PO, 2 100mg tablet"
15896930|NCT03674060|Drug|Nexavar tab|Nexavar 200mg/tablet, PO, 1 tablet
15896931|NCT03674047|Drug|ruxolitinib|Ruxolitinib blocks certain proteins called tyrosine kinases. Specifically, it blocks tyrosine kinases called JAK2. it's believe that ruxolitinib may lower the rate of GVHD through its ability to block the JAK2 pathway since this pathway can lead to inflammation in the body
15896932|NCT03674034|Other|CTscan and MRI images|CTscan and MRI images segmented according to procedures previously developed by GRAMFC
15896933|NCT03674021|Other|Chest Pain Choice visual aid|The Chest Pain Choice (CPC) decision aid is a visual aid that was developed to facilitate shared decision-making between physicians and patients who present to the emergency department with chest pain. The visual aid includes a brief description of what tests have been done thus far to assess the patient's risk of MACE, a graphic representation of the risk as calculated based on the HEART score, as well as the evaluation options available. The visual aid has been modified from its original form for the local context in terms of viable options for further evaluation.
15896934|NCT03674008|Drug|HSK3486|HSK3486 intravenous (iv) 0.4 mg/kg for induction, and 0.2 mg/kg top-ups for maintenance.
15896935|NCT03674008|Drug|Propofol|Propofol iv 1.5 mg/kg for induction, and 0.75 mg/kg top-ups for maintenance.
15896936|NCT03673995|Dietary Supplement|Myo-inositol+L-tyrosine|PCOS patients were treated every day, with one sachet containing 2000 mg myo-inositol, 500 mg L-tyrosine, 40 mcg chromium picolinate, 55 mcg selenium, 200 mcg folic acid. All patients underwent, before starting the therapy, after 3 months and 6 months, hormonal, hirsutism and ovulation assesment.
15896937|NCT03673982|Behavioral|iCASK|Materials and support to aid transitions
15896938|NCT03673969|Procedure|Gastric bypass|Surgical method of gastric bypass
15896939|NCT03673956|Drug|Topical Antibiotic Nasal Saline Irrigation|The topical antibiotics will prescribed to the patient in capsule form as compounded by the Mayo Clinic pharmacy, or suitable licensed 3rd party compounding pharmacy. One capsule will subsequently be added to a nasal saline irrigation bottle, and the patient will administer this irrigation to him or herself in the usual fashion twice per day. The antibiotic prescribed may be either Tobramycin, Mupirocin, Gentamicin or Levofloxacin.
15896940|NCT03673943|Drug|64Cu-DOTATATE|Detection of somatostin positive lesions in NET
15896941|NCT03673930|Dietary Supplement|Zanthozylum armatum|Zanthozylum armatum MCT oil extract
15896942|NCT03673930|Dietary Supplement|Placebo|sunflower oil matched for appearance
15896943|NCT03673917|Other|Educational video|The educational video on skin cancer for cosmetologists
15896944|NCT03673917|Other|Control video|A publicly accessible healthy lifestyle video on YouTube, which does not contain any information on skin cancer
15896945|NCT03673891|Device|Life Flow|LifeFlow device will be used to administer intravenous fluids in this group. LifeFlow is a FDA approved device to administer IV fluids. Subject will have a bedside ultrasound performed by the study investigator after receiving 500 ml of intravenous fluid bolus. The images will be recorded on ultrasound machine hard drive for future review. If the bedside ultrasound findings determine that the subject is not fluid responsive, subjects will be excluded from the study. If the subject is determined to be fluid responsive, the above listed outcome measures will be collected. Ultrasound will be repeated after every 500 ml bolus if the patient continues to receive IV fluids which will be determined by the treating physician. Ultrasound measurements and other parameters listed above will be collected throughout the ED and hospital stay.
15896990|NCT03673605|Drug|Rivaroxaban 15 mg|Rivaroxiban in stroke prevention in patients with Mitral Stenosis and AF.
15896991|NCT03673605|Drug|Warfarin|Warfarin in stroke prevention in patients with Mitral Stenosis and AF.
15896948|NCT03673852|Behavioral|WE Harambee|WE Harambee is a 6-month intervention, comprised of twice a week group meetings for 12 weeks, followed by a second 12 weeks of individual peer coaching/navigation. WE Harambee aims to enhance access to and engagement in primary care and behavioral health services, as well as improve overall health and well-being, including the 8 dimensions of wellness and social determinants of health.
15896949|NCT03673852|Behavioral|Behavioral Health Home Enrollment|A BHH is a Center for Medicaid Services program supporting Medicaid beneficiaries with complex needs, typically multiple chronic conditions impacting both physical and behavioral health. Utilizing a team-based clinical approach that includes the patient, his/her providers, and possibly family members, BHH programs target service fragmentation by linking community supports and resources as well as by enhancing the integration of primary and behavioral health care. Care Coordinators oversee and facilitate access to all services an individual needs to stay as healthy as possible, aiming to promote continuous health management not mere resolution of repeated acute episodes.
15896950|NCT03673839|Other|Animal Proteins (crossover)|Animal proteins mixed with water and consumed as a beverage once by the subject in a 4x4 Williams square crossover design
15896951|NCT03673839|Other|Plant-based protein blends type 1 (crossover)|Plant-based protein blends mixed with water and consumed as a beverage once by the subject in a 4x4 Williams square crossover design
15896952|NCT03673839|Other|Plant-based protein blends type 2 (crossover)|Plant-based protein blends mixed with water and consumed as a beverage once by the subject in a 4x4 Williams square crossover design
15896953|NCT03673839|Other|Plant-based protein blends type 3 (crossover)|Plant-based protein blends mixed with water and consumed as a beverage once by the subject in a 4x4 Williams square crossover design
15896954|NCT03673826|Drug|Carfilzomib|9 cycles 20/36mg/m2 days 1,2,8,9,15,16
15896955|NCT03673826|Drug|Dexamethasone|4 cycles 20 mg days 1,2,8,9,15,16,22,23 followed by 5 cycles 10mg days 1,2,8,9,15,16,22,23
15896956|NCT03673826|Drug|Lenalidomide|9 cycles 25mg days 1-21 followed by 24 extended dosing cycles 10mg days 1-21
15896957|NCT03673800|Other|Experimental Group|Cognitive web-based training : 2 up to 30 minutes sessions a week during 6 weeks. Optional debriefing by a neuropsychologist up to 15 minutes twice a week
15896958|NCT03673800|Other|Control Group|Sensorial web-based training : 2 up to 30 minutes sessions a week during 6 weeks. Optional debriefing by a neuropsychologist up to 15 minutes twice a week
15896959|NCT03673787|Drug|ipatasertib|Ipatasertib will be supplied as film-coated tablets in two strengths (100 and 200 mg) differentiated by size, shape, and weight of tablets. Ipatasertib tablets are packaged in high-density polyethylene bottles with desiccant.
15896960|NCT03673787|Drug|Atezolizumab|Atezolizumab will be supplied as a single-use 20 mL USP/Ph. Eur Type 1 glass vial as a colourless-to-slightly-yellow, sterile, preservative-free clear liquid solution intended for intravenous (IV) administration.
15896962|NCT03673761|Other|MRI, dual-energy, x-ray absorptiometry, muscle ultrasounds, blood testing|3.Dixon, T2 mapping MRI microRNAs
15896963|NCT03673748|Drug|Mesenchymal stromal cells (MSC)|Endovenous injection of MSV in saline
15896964|NCT03673748|Drug|Placebo|Endovenous injection of saline without cells
15896965|NCT03673735|Drug|Durvalumab|Durvalumab (one dose) before CRT and for 6 months Q4W after CRT
15896966|NCT03673735|Radiation|radiotherapy|radiotherapy is administered in 33 fractions over 6.5 weeks fro a total of 66 Gy
15896967|NCT03673735|Drug|Placebo|placebo (one dose) before CRT and for 6 months Q4W after CRT
15896968|NCT03673735|Drug|Cisplatin|Cisplatin (100mg/m2) is administered at day 1, 22, 43 of radiotherapy
15896969|NCT03673722|Other|Foods consistent with a MDP|We aim to increase MDP by 3 points, according to a 14-point MEDAS score
15896970|NCT03673722|Other|Physical Activity|We aim to increase PA to 150 minutes moderate activity per week.
15896971|NCT03673722|Other|Control|Participants will be given generic healthy eating advice based
15896972|NCT03673709|Behavioral|Antenatal Care|Women in group care bypass the waiting room and have a 2-hour visit with the same provider with a group of 8-12 women at a similar stage of pregnancy. Women assess their own blood pressure and weight, briefly consult the midwife in a corner of the room, and meet for 80-90 minutes of interactive health promotion, enlivened by games and role-plays.
15896973|NCT03673696|Drug|HEC74647PA Capsule|Capsule administered orally once daily
15896974|NCT03673696|Drug|placebo|Matching Placebo Capsule
15896975|NCT03673683|Behavioral|SANDWICH protocol|A protocol based intervention incorporating co-ordinated care with greater nursing involvement; patient-relevant sedation plans linked to regular assessment using the COMFORT scale; regular assessment of ventilation parameters with a higher than usual trigger for undertaking an extubation readiness test; a spontaneous breathing trial (SBT) on low levels of respiratory support to test extubation readiness
15896976|NCT03673683|Behavioral|Usual care|Usual sedation and weaning management that is not protocol based
15896977|NCT03673670|Drug|RPL554 Suspension|A PDE3/4 inhibitor
15896978|NCT03673670|Drug|Placebo|A placebo solution
15896979|NCT03673670|Drug|Tiotropium/olodaterol (Respimat)|An anticholinergic/β-agonist combination medication
15896980|NCT03673657|Dietary Supplement|ONS from the start of radiotherapy|ONS from the start of radiotherapy
15896981|NCT03673657|Dietary Supplement|ONS from the time of grade 2 radiation esophagitis|ONS from the time of grade 2 radiation esophagitis
15896982|NCT03673657|Dietary Supplement|Energy goal-based ONS|Energy goal-based ONS
15896983|NCT03673657|Dietary Supplement|Prealbumin goal-based ONS|Prealbumin goal-based ONS
15896984|NCT03673657|Radiation|Thoracic radiotherapy|Definitive thoracic radiotherapy with total radiation doses of 60-70 Gy
15896985|NCT03673657|Drug|Weekly DP chemotherapy concurrent with thoracic radiotherapy|Weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with thoracic radiotherapy
15896986|NCT03673644|Other|Questionnaires|Two questionnaires will be administered, one focusing on life space and the other focusing on low luminance.
15896987|NCT03673631|Device|NIV|NIV setting: minimal FiO2 0.3; tidal volume 6-8ml/kg (theoretical body weight)
15896988|NCT03673631|Device|NFHC-O2|NFHC-O2 setting: minimal FiO2 0.3; minimal flow 40l/min
15896989|NCT03673618|Drug|Soluble Corn Fiber|Fiber or placebo
15896992|NCT03673592|Diagnostic Test|PGT-A|PGT-A will be carried out following the usual clinical practice: Trophectoderm biopsy samples from blastocysts are analyzed by NGS to screen for numerical chromosomal abnormalities.
15896993|NCT03673579|Device|NICU Dashboard|The NICU Dashboard is displayed on a touch screen display mounted to the wall or on a rolling cart that will be placed near the bedside. The Dashboard will integrate information from various hospital/device sources in order to provide clinicians with one location to access and collectively interpret clinical findings and environmental factors. Parents will have their own view on the Dashboard that will allow them view their baby's progress, view educational materials, and have access to other resources at their fingertips.
15896994|NCT03673566|Device|NICU Dashboard|The NICU Dashboard is displayed on a touch screen display mounted to the wall or on a rolling cart that will be placed near the bedside. The Dashboard will integrate information from various hospital/device sources in order to provide clinicians with one location to access and collectively interpret clinical findings and environmental factors. Parents will have their own view on the Dashboard that will allow them view their baby's progress, view educational materials, and have access to other resources at their fingertips.
15896995|NCT03673553|Other|Multimodal treatment of patients with FM|The intervention group took part in 2.5-hour sessions of MRT once a week for 10 weeks. This intervention combined physical exercise with stretching. Health education was geared towards pain management, the pathology itself, healthy habits, insomnia, postural correction and ergonomics. The psychological approaches used in the MRT were problem-solving therapy, cognitive behavioural therapy and sophrology. Given the diversity of the sessions, they were directed by a rheumatologist, a nurse, a psychologist, and a physiotherapist. If the patient needed their pharmacological treatment to be altered, they were offered an appointment with the rheumatologist.
15896996|NCT03673553|Other|Association of people with fibromyalgia|The control group attended the activities organised by the association of people with FMS. These consisted of a weekly 1-hour session of group psychology and a weekly 2-hour session of handicrafts for 10 weeks.
15896997|NCT03673540|Behavioral|CBT+ application|Smartphone application that comprises electronic self-monitoring of food intake, eating disorder behaviors, and mood and ecological momentary interventions
15896998|NCT03673527|Drug|topical formulation of tacrolimus|Topical application of tacrolimus twice daily for 14 days (one dose on Day 14).
15896999|NCT03673514|Procedure|Total hip arthroplasty|Two fellowship-trained surgeons in two separate hospitals performed all procedures. Both surgeons had previously performed over 100 cases with each approach, before initiating this study
15897000|NCT03673501|Drug|DCC-2618|Oral KIT/PDGFRA kinase inhibitor
15897001|NCT03673501|Drug|Sunitinib|Oral receptor tyrosine kinase (RTK) inhibitor
15897002|NCT03673488|Device|TephaFlex™ mid-urethral sling|The sling is made from P4HB material. It is placed in a similar technique to standard retropubic sling procedures, but will resorb over 18-24 months post surgery.
15897003|NCT03673475|Procedure|Assessment of fluid responsiveness|assessment of intravascular volume status using pleth variebility index and internal jugular vein distensibility in major abdominal surgery
15897004|NCT03673462|Biological|Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine (MenACYW conjugate vaccine)|Pharmaceutical form: liquid solution. Route of administration: Intramuscular
15897005|NCT03673462|Biological|Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®)|Pharmaceutical form:Lyophilized powder combined with liquid components Route of administration: Intramuscular
15897006|NCT03673462|Biological|Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine|Pharmaceutical form:Liquid DTaP-IPV to reconstitute lyophilized ActHIB Route of administration: Intramuscular
15897007|NCT03673462|Biological|Pneumococcal 13-valent Conjugate Vaccine|Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
15897008|NCT03673462|Biological|Rotavirus Vaccine|Pharmaceutical form:Oral solution Route of administration: Oral
15897009|NCT03673462|Biological|Hepatitis B Vaccine|Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
15897010|NCT03673462|Biological|Measles, Mumps, and Rubella Virus Vaccine|Pharmaceutical form:Lyophilized live virus vaccine Route of administration: Subcutaneous
15897011|NCT03673462|Biological|Varicella Virus Vaccine|Pharmaceutical form:Suspension for injection Route of administration: Subcutaneous
15897012|NCT03673449|Device|SilkBridge|SilkBridge is a biocompatible silk fibroin-based scaffold, which recruits the patients' own cells to remodel or regenerate the nerve, without pre-seeding of the scaffold nor biological/chemical treatments.
15897013|NCT03673436|Procedure|Lumbar spinal fusion|The patient got a instrumented fusion of a maximum of 3 adjacent vertebrae
15897014|NCT03673410|Procedure|Robotic bariatric surgery - revisional|Using robotic techniques during any revesional bariatric surgery
15897015|NCT03673410|Procedure|Laparoscopic bariatric surgery - revisional|Using laparoscopic techniques during any revesional bariatric surgery
15897016|NCT03673397|Behavioral|Aerobic exercise, bicycle ergometer|Exercise performed below individual anaerobic threshold for 30 minutes
15897017|NCT03673384|Device|infrared-C ray irradiation|Infrared-C irradiation by hot compress with a powered heating compress
15897018|NCT03673384|Device|eye mask|infrared-C irradiation by hot compress with a powered heating eye mask
15897019|NCT03673384|Drug|Xyzal Oral Product|used to relieve allergy symptoms, It works by blocking histamine that body secretes during an allergic reaction.
15897020|NCT03673384|Drug|Fluticasone Furoate|used to treat seasonal and perennial allergic rhinitis. It also helps to reduce the symptoms of seasonal allergic rhinitis.
15897021|NCT03673371|Other|Questionnaire|This is a questionnaire developed by DoD and VA researchers specifically for this study.
15897022|NCT03673358|Behavioral|Cognitive Behavioural Therapy|"Participants who are randomized to the CBT intervention will be encouraged to begin CBT immediately following randomization. The CBT intervention will focus on addressing maladaptive beliefs related to pain and recovery as well as teaching skills to enhance coping and management of pain symptoms. The specific focus of CBT sessions will be informed by each individual patient's responses to baseline questionnaires. All other aspects of post-operative care will be at the discretion of participant's surgeon.
~Other Name: CBT"
15897052|NCT03673124|Drug|Ribociclib|600 mg by mouth daily for 21 days followed by 7 days off treatment
15897053|NCT03673124|Drug|Letrozole|2.5 mg by mouth daily
15897023|NCT03673345|Biological|Influenza Virus Quadrivalent Inactivated Vaccine|A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N3) and 2 influenza B subtypes (B Yamata lineage B Victoria lineage).
15897024|NCT03673332|Drug|immune-checkpoint inhibitors therapies|All patients included in this study will receive approved immune-checkpoint inhibitors therapies, such as CTLA-4, PD-1, and PD-L1 inhibitors.
15897025|NCT03673319|Procedure|Dry needling with positives expectation|"DN procedure: is a very effective form of treatment used to treat neck-shoulder pain and it is expected to reduce your perception of pressure pain"
15897026|NCT03673319|Procedure|Dry needling with neutral expectation|"DN procedure: is a form of treatment used to treat neck-shoulder pain that has unknown effects on your perception of pressure pain"
15897027|NCT03673306|Other|Clinical outcomes|Clinical outcomes
15897028|NCT03673280|Procedure|Quadratus Lumborum Block|Instead of using morphine in the classical spinal anaesthesia we will be performing in the experimental group the Quadratus Lumborum Block
15897029|NCT03673267|Behavioral|Nutricity|Participants will use their smartphone or web-accessing device to access the Nutricity website to potentially increase nutrition literacy and set nutrition goals. Participants will have their own user name and password to access the site. Access to Nutricity will last approximately 3 months.
15897030|NCT03673254|Device|rotational atherectomy device|angioplasty with rotational atherectomy device on a nonselected population
15897031|NCT03673241|Device|Guardian System|The Study arm will have the Guardian system applied to their bed and recovery chair with the intent for the patient to have the inflatable surface utilized underneath them .
15897032|NCT03673228|Behavioral|Comprehensive Relapse Prevention Intervention|"This intervention consists of 4 components:
~Visit Prior to Discharge: counselor from research team will visit patient at hospital bedside to provide counseling
~Follow up calls after discharge: 6 proactive counseling calls and initiate unlimited reactive calls to their counselor, at days 1,3,7,14,30,an 60 days after hospital visit
~Text messaging support: patients will be registered in NCI's Smokefree TXT while in the hospital and will receive multiple daily messages, designed for someone who has already quit
~Caregiver support: 10 minute training session to the caregiver on how to help patient prevent relapse by increasing self efficacy, maintaining motivation and dealing with high risk situations"
15897033|NCT03673228|Behavioral|Standard Treatment Counseling|Participants will receive two 10 minute counseling calls from the staff of the preoperative counseling program during the first month after the hospital discharge
15897034|NCT03673228|Drug|Nicotine Replacement Therapy (NRT)|Patients in both arms will be encouraged to receive NRT
15897035|NCT03673215|Drug|Recombinant human thrombopoietin|Recombinant human thrombopoietin will be administered single dose 300 U/Kg subcutaneous injection in the patients with liver function impairment classified as Child-Pugh class A
15897036|NCT03673215|Drug|Recombinant human thrombopoietin|Recombinant human thrombopoietin will be administered single dose 300 U/Kg subcutaneous injection in the patients with liver function impairment classified as Child-Pugh class B.
15897037|NCT03673215|Drug|Placebo|Placebo will be administered single dose subcutaneous injection in the patients with liver function impairment classified as Child-Pugh class B.
15897038|NCT03673215|Drug|Recombinant human thrombopoietin|Recombinant human thrombopoietin will be administered single dose 150 U/Kg subcutaneous injection in the patients with liver function impairment classified as Child-Pugh class C.
15897039|NCT03673215|Drug|Placebo|Placebo will be administered single dose subcutaneous injection in the patients with liver function impairment classified as Child-Pugh class C
15897040|NCT03673215|Drug|recombinant human thrombopoietin|Recombinant human thrombopoietin will be administered single dose 300 U/Kg subcutaneous injection in the patients with liver function impairment classified as Child-Pugh class C.
15897041|NCT03673215|Drug|placebo|Placebo will be administered single dose subcutaneous injection in the patients with liver function impairment classified as Child-Pugh class C
15897042|NCT03673215|Drug|Recombinant human thrombopoietin|Recombinant human thrombopoietin will be administered single dose 450 U/Kg subcutaneous injection in the patients with liver function impairment classified as Child-Pugh class C.
15897043|NCT03673215|Drug|placebo|Placebo will be administered single dose subcutaneous injection in the patients with liver function impairment classified as Child-Pugh class C
15897044|NCT03673202|Diagnostic Test|Cx bladder Monitor test|Cxbladder Monitor is a non-invasive UC detection test measuring five messenger RNA (mRNA) biomarkers present at elevated levels in patients presenting with urothelial carcinoma and also two clinical variables (whether the previous tumor was primary or recurrent and the time since the previous tumor was resected).
15897045|NCT03673189|Device|sensors|Acquisition and transmission of exploitable recordings in the public targeted by the DS, that is to say which allow to draw clinical information in relation to the objectives of the DS (detection of the cardiac rhythm): data without artefact (saturation), in a good signal to noise ratio.
15897046|NCT03673176|Radiation|Stereotactic Ablative Radiotherapy (SABR)|The prescribed dose will be 45 Gy in three fractions of 15 Gy, on each side that is treated.
15897047|NCT03673163|Drug|Lidocaine|Infusion of 2% lidocaine hydrochloride at 4 mL/h,prior to surgery and discontinued until 24 h after surgery.
15897048|NCT03673163|Drug|Control|Infusion of normal saline at 4 mL/h, prior to surgery and discontinued until 24 h after surgery.
15897049|NCT03673150|Other|non intervention|Observational study / non intervention
15897050|NCT03673137|Device|Irreversible electroporation|During the IRE process, we employed a CT scanner and an ultrasound system to guide percutaneous insertion of the electrode probes (one main electrode and one to three standard electrodes were used per treatment). The electrode number, electrode-insertion mode and intraoperative parameters were decided upon during pretreatment planning. The IRE parameters were visually simulated in the pulse generator and set up as follows: energy was applied at 1500 V/cm for 90 ms/pulse for a total of 7-9 pulses. After an initial testing pulse train was discharged to establish the best voltage value, the remaining 80 pulses were completed in 1-2 minutes. After ablation, we confirmed completion of IRE by measuring real-time resistance or current changes, in addition to intraoperative ultrasound and CT.
15897051|NCT03673137|Drug|Gemcitabine|Gemcitabine hydrochloride (Qilu pharmaceutical [Hainan] Co., Ltd. Haikou, China] was administered by intravenous infusion at a dose of 1000 mg/m2.
15897056|NCT03673098|Behavioral|Adapted 3RP|The 3RP blends stress management principles, cognitive behavioral therapy, and positive psychology. The 3RP focuses on 3 major areas: (1) eliciting the relaxation response; (2) increasing stress awareness; and (3) promoting adaptive strategies. The adapted 3RP intervention consists of 10, 90-minute weekly group sessions. Content specific to older women living with HIV, including self-compassion exercises, was added to the intervention in the first phase of this study (open pilot).
15897057|NCT03673085|Drug|CN128|CN128
15897058|NCT03673085|Other|placebo|The tablets without CN128
15897059|NCT03673072|Drug|Gemcitabine|Gemcitabine (1000 mg/m2) in 250-500 ml 0.9% saline every three weeks on days 1 and 8 intravenously
15897060|NCT03673072|Drug|Cisplatin|Cisplatin (25 mg/m2) every three weeks on days 1 and 8 intravenously, in 1000 ml 0.9% saline with KCl 20 mmol and MgSO4 8 mmol during the one hour cisplatin infusion followed by 500 ml 0.9% saline over 30 minutes prior to gemcitabine; with adequate pre- and posthydration
15897061|NCT03673072|Procedure|Oncologically radical margin-free (R0) resection|Oncologically radical margin-free (R0) resection
15897062|NCT03673072|Drug|Adjuvant chemotherapy|Can be selected by Investigator's Choice
15897063|NCT03673059|Drug|OTC Eczema Moisturizer Regimen|Subjects were assigned to use an OTC, oatmeal-containing eczema therapy moisturizing cream twice daily on their face and entire body for the 14-day treatment period of the study, in place of any other moisturizers/emollients. Subjects were also provided with a mild cleanser to use in place of their normal body wash and/or soap (same cleanser as used by Group B) per their usual cleansing routine. After the 14-day treatment period, subjects discontinued use of the moisturizer for the 7-day regression period.
15897064|NCT03673059|Other|Cosmetic Moisturizer Regimen|Subjects were assigned to use a non-fragranced, dry skin daily moisturizer twice daily on their face and entire body for the 14-day treatment period of the study, in place of any other moisturizers/emollients. Subjects were also provided with a mild cleanser to use in place of their normal body wash and/or soap (same cleanser as used by Group A) per their usual cleansing routine. After the 14-day treatment period, subjects discontinued use of the moisturizer for the 7-day regression period.
15897065|NCT03673046|Device|Smartphone-delivered CBT for BDD|12-week Smartphone-delivered CBT for BDD. In-person cognitive behavioral therapy (CBT) is an empirically supported treatment for BDD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., exposure with ritual prevention), and perceptual retraining/mindfulness skills.
15897066|NCT03673033|Procedure|liver transplantation|calculation of hot and cold ischemia durations from donor artery cut-off time in liver transplantation
15897067|NCT03673020|Biological|ASV® AGEN2017 + QS-21 Stimulon® adjuvant|Neoantigen Vaccine
15897068|NCT03673007|Behavioral|Gift card to be used for contraceptives that is valued at 50% of cost of name-brand IUD (August 26, 2018-March 3, 2019)|M-CARES will randomize allocation of vouchers (gift cards) for contraception valued up to 50% of inserting a name-brand IUD (e.g., Skyla, Paraguard, Mirena) for women with out of pocket costs at Planned Parenthood. This intervention occurred between August 18, 2018, and March 3, 2019.
15897069|NCT03673007|Behavioral|Gift card to be used for contraceptives that is valued at 100% of cost of name-brand IUD (March 4, 2019-December 31, 2021)|M-CARES will randomize allocation of vouchers (gift cards) for contraception valued up to 100% of inserting a name-brand IUD (e.g., Skyla, Paraguard, Mirena) for women with out of pocket costs at Planned Parenthood. This intervention occurred after March 3, 2019.
15897070|NCT03672981|Behavioral|Exercise Intervention|Undergo resistance training program and cardiovascular exercise
15897071|NCT03672981|Other|Quality-of-Life Assessment|Ancillary studies
15897072|NCT03672981|Other|Questionnaire Administration|Ancillary studies
15897073|NCT03672981|Behavioral|Telephone-Based Intervention|Participate in phone calls with exercise physiologist
15897074|NCT03672968|Genetic|GS010|
15897075|NCT03672942|Behavioral|Communication Skills Training|Gentle start-up is one treatment technique in the Creating Healthy Relationship Program written by John Gottman, Ph.D.
15897076|NCT03672942|Behavioral|Mindfulness|Acceptance/willingness of unwanted emotions is treatment technique of Achieving Change through Value-Based Behavior (ACTV) written by Amie Zarling, Ph.D.
15897077|NCT03672942|Behavioral|Placebo|Couples randomly assigned to this condition listen to music on headphones. This may be considered an active placebo as it is similar to a Time Out technique taught in battering interventions.
15897078|NCT03672929|Device|RSA|Roentgen Stereometric Analysis (RSA) is a very accurate measurement technique used to obtain micromotion of the implants relative to bone, by means of inserted tantalum markers in the surrounding acetabulum and femur. RSA provides data on the in-vivo stability of the Cup System within 2 years.
15897079|NCT03672903|Device|Weight Vest|A vest with added weights up to a maximum of 15 kg.
15897080|NCT03672890|Other|Telestroke|Telestroke is an audiovisual communication network that allows for coordination of stroke care from a distant 'hub' site (the telestroke provider location) to an originating 'spoke' site (patient location) in a HIPAA compliant fashion. In TELECAST, inpatient telestroke rounding will be used to oversee the urgent diagnostic stroke evaluation, secondary stroke prevention, health screening & evaluation, and stroke education in patients admitted with stroke.
15897081|NCT03672877|Behavioral|Intensive exercise|Intensive, child-initiated activities of the lower extremities including walking (with or without support), kicking, jumping, standing balance, climbing stairs and slopes and other leg activities. Small weights will be added to the ankle and foot to increase the intensity of the exercise. Sessions will be one hour long, 4 days a week. A physical therapist or designate will supervise sessions.
15897082|NCT03672864|Behavioral|Intensive exercise|Intensive, child-initiated movement of the lower extremity: 1 hour/day, 4 days/week, 2 sessions delivered by a physical therapist, 2 delivered by a parent. All activities are play based, and exercise intensity is enhanced by small weights placed on the dorsum of the foot and the ankle of the affected limb. Intervention is delivered over 12 weeks for a target of 48 hours of training.
15897083|NCT03672851|Drug|anti-CD123 CAR-T treatment|Patients receive fludarabine phosphate(300 mg/m^2) and cyclophosphamide (30 mg/m^2) IV on days -5 to -3, and then Patients receive autologous anti-CD123 CAR T cells IV over 20 minutes on day 0 (20% of total dose), day2 (30% of total dose) and day6 (50% of total dose, according to the side-effects occured). The total dose of CAR-T cells used in dose-escalation study is 0.5x10^6- 2.0x10^6 CAR-T cells/kg.
15897330|NCT03670953|Drug|IPX203 ER CD-LD|Investigational formulation - ER CD-LD
15897084|NCT03672838|Behavioral|hand-held dynamometer|Strength of one weak muscle group and of the biceps of the dominant arm will be measured using a hand-held dynamometer. An average of three readings will be used as one observation. Three observations per patient will be obtained on one day with a minimum of 15 minute rest period between each observation.
15897085|NCT03672825|Drug|REcycled CartiLage Auto/Allo IMplantation|Treating cartilage defects with autologous (your own) cartilage cells mixed with allogeneic (from someone else) adipose-derived mesenchymal stem cells (AMSCs).
15897086|NCT03672812|Drug|Liraglutide|liraglutide 3mg 6/6 hours
15897087|NCT03672799|Behavioral|Rehabilitation Planning Consult (RPC)|"Participants allocated to RPC will receive a 1 hour consultation with the Rehabilitation Consult and second consultation over the next 12 weeks as needed.
~Participants will be assessed at three time points, 1) Baseline assessment, 1 week prior to RPC, 2) post-intervention assessment, 1 week after RPC, and 3) follow-up assessment, 13 weeks after RPC."
15897088|NCT03672799|Other|Wait list control (WLC)|"Participants who are allocated to WLC will complete a 12 week waiting period. At the end of the waiting period, participants will crossover to the RPC group.
~Participants will be assessed at four time points, 1) Baseline assessment, 1 week prior to waiting period, 2) post-waiting period assessment, 1 week after waiting period, 3) post-intervention assessment, 1 week after RPC, and 4) follow-up assessment,13 weeks after RPC."
15897089|NCT03672786|Dietary Supplement|Multicentrum|The multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) will be maintained during 2 months
15897090|NCT03672773|Drug|Talazoparib|Given PO
15897091|NCT03672773|Drug|Temozolomide|Given PO
15897092|NCT03672760|Device|CardioBreathApp|Respiratory exercises performed with CardioBreathApp prescription and voice and visual guidance
15897093|NCT03672760|Device|IMT PowerBreath|Inspiratory Muscle Training (IMT) performed with 30% load based on Maximal Inspiratory Pressure
15897094|NCT03672760|Device|IMT PowerBreath Placebo|Inspiratory Muscle Training (IMT) without load
15897095|NCT03672747|Device|transcranial direct-current stimulation (tDCS)|20 minutes duration using high-definition system with center-surround configuration
15897096|NCT03672721|Drug|IA Carbo+ Radiation|combination of intraarterial carboplatin + radiation in dose escalation
15897097|NCT03672708|Diagnostic Test|Cresyl violet|cresyl violet is applicated at the concentration of 0.15% via a spraying catheter to visualize cellular and tissue architecture in the pCLE
15897098|NCT03672695|Combination Product|S 64315 (also referred as MIK665) and venetoclax|"The treatment combination period can only begin after the planned dose of venetoclax is reached. Depending on the administration dosing schedule, the combination treatment at the planned doses may be preceded by a 2-week Lead-In Dose period of S64315 (fixed dose) during which the patient continues to receive venetoclax daily. Once the planned dose of both drugs is reached the schedule will be a 21-day cycle with a weekly regimen for S64315 and a daily regimen for venetoclax.
~S64315 should be administered 2 to 4 hours after venetoclax intake, via IV infusion. The dose escalation will start at 50 mg once a week and doses up to 250 mg once a week might be explored.
~Venetoclax will be administered orally once a day. The dose escalation will start at 100 mg daily and doses up to 600 mg daily might be explored. Venetoclax must be taken with a meal (ideally during breakfast) in order to avoid reduced efficacy."
15897099|NCT03672669|Genetic|Advanced Platelet Rich Fibrin (A-PRF)|blood samples collected in 10 ml of vacuumed plain glass tubes were centrifuged for 14 minutes at 1500 rpm without anticoagulant agents in order to obtain A-PRF
15897100|NCT03672669|Genetic|Leukocyte- and platelet-rich fibrin (L-PRF)|blood samples collected in 10 ml of glass coated plastic tubes were centrifuged without anticoagulant agents for 10 minutes in order to obtain L-PRF
15897101|NCT03672656|Device|lasercoagulation by Pascal system|pattern scanning laser system Pascal given in a single-session
15897102|NCT03672656|Device|conventional laser|conventional laser multiple-session treatment
15897103|NCT03672643|Drug|Crizotinib|receive crizotinib orally
15897104|NCT03672630|Drug|Azithromycin|Azithromycin 500 MG Oral Tablet [ZITHROMAX]
15897105|NCT03672630|Drug|Ethambutol|Ethambutol 25 mg/kg [MYAMBUTOL]
15897106|NCT03672630|Drug|Rifampin|Rifampin 600 MG [RIFADIN]
15897107|NCT03672617|Other|No treatment given|"No treatment is given to study participants. Only evaluation of a questionnaire assessing reasons for non-adherence to growth hormone therapy (GHT) and to determine its validity and reliability.
~The preliminary working title of the questionnaire GHCQ used in the outcome measures was renamed for simplicity reasons into BAR-GHT (abbreviation for barriers to growth hormone therapy) after study completion."
15897108|NCT03672604|Drug|NLY01|NLY01, a PEGylated form of the anti-diabetic peptide exenatide
15897109|NCT03672591|Other|Renal clearance examination|Evaluation of renal hemodynamic parameters by constant-infusion input clearance technique with p-aminohippuric acid and Iohexol
15897110|NCT03672578|Other|loss-frame|loss frame label
15897111|NCT03672578|Other|gain-frame|gain frame label
15897112|NCT03672578|Other|text-only|text-only label
15897113|NCT03672578|Other|icon|label with icon and text
15897114|NCT03672578|Other|attribution|label with attribution
15897115|NCT03672578|Other|no attribution|label with no attribution
15897116|NCT03672578|Other|No label|No label
15897117|NCT03672565|Behavioral|Phase One: Standardized Brief Intensive ERP|Participants will be randomized to receive ERP sessions at the hospital or at relevant community locations. In the introductory session, participants will be provided with psychoeducation about OCD and the treatment model, will develop a list of potential exposures, and will attempt initial exposure and response prevention (ERP) exercises. The session will end with an assignment of ERP homework. In the seven days following the introductory session, youth and parents will receive two 3-hour sessions, separated by a three day break. The sessions will begin with a brief review of homework completion and success. Following this, with parent observation, the clinician will guide the youth through escalating ERP exercises. The session will end with ERP homework planning. Other evidence-based treatment strategies (e.g., addressing motivation, discussing parental accommodations) may be implemented as deemed necessary by the clinician in order to encourage effective engagement in ERP exercises.
15897152|NCT03672331|Other|Tomosynthesis|As required according to the national/regional guidelines or personalised schedule according to risk assessment
15897331|NCT03670953|Other|IPX203 placebo|Double dummy placebo capsules
15897332|NCT03670953|Other|IR CD-LD placebo|Double dummy placebo tablets
15897118|NCT03672565|Behavioral|Phase Two: Flexible Patient Driven Intensive ERP|"Families will have the opportunity to access up to four additional once/week 3-hour intensive ERP sessions.
~Three days prior to each additional ERP session (sessions 3-6), families will be prompted to fill out online forms and decide how to proceed with treatment for that week with the following options:
~They may select that they would like to receive and complete the next ERP session, and up to four 3-hour ERP sessions during Phase Two. Completion of all four ERP session will automatically end Phase Two.
~They may opt to delay receiving a treatment session by one week for any reason. Families will be allowed to take a week off up to two times during Phase Two. If both weeks off are utilized, at the next decision point families must either opt to complete an ERP Session or end their participation in Phase Two.
~They may select to end their participation in Phase Two at any decision point and for any reason (e.g., don't perceive it as helpful, have improved substantially)."
15897119|NCT03672565|Behavioral|Follow-Up Phase: Booster Calls|Upon achieving remission at any remission assessment or completion of remission assessment five, youth will enter the follow-up phase. Youth will receive three weekly 30 minute post-treatment booster phone calls. Calls will focus on homework completion, ERP planning, and relapse prevention skills.
15897120|NCT03672552|Other|FFWP and Improved Oral Care|The FFWP with dental hygiene participants will have assessments for swallowing and oral health then proceed to have a dental hygienist cleaning. This intervention group will have supervised and assisted tooth brushing by nursing staff before taking plain (thin) unmodified water and between meals.
15897121|NCT03672539|Drug|Gemtuzumab Ozogamicin|Given IV
15897122|NCT03672539|Drug|Liposome-encapsulated Daunorubicin-Cytarabine|Given IV
15897123|NCT03672539|Other|Quality-of-Life Assessment|Ancillary studies
15897124|NCT03672526|Device|measure of injection pressure by compuflo|injection pressure mesured by Compuflo
15897125|NCT03672513|Dietary Supplement|Placebo Comparator|Oral administration of 1 daily capsule containing lactose
15897126|NCT03672513|Dietary Supplement|Zinc Supplement|Oral administration of 1 daily capsule containing 50 mg/day of Zn
15897127|NCT03672513|Dietary Supplement|Magnesium supplement|Oral administration of 1 daily capsule containing 500 mg/day of Magnesium
15897128|NCT03672500|Drug|Bupivacaine 0.5%+Epinephrine 50mc|Local infiltration of the perineum with Bupivacaine 0.5%+Epinephrine 50mc
15897129|NCT03672500|Other|Sham injection|Sham injection of the perineum
15897132|NCT03672474|Device|Photobiomodulation REGEnLIFE RGn530 device|For the photobiomodulation group the device is set up and activated. REGEnLIFE RGn530 medical device will follow EC labelling if proven to be safe and effective
15897133|NCT03672474|Device|SHAM REGEnLIFE RGn530 device|For the photobiomodulation group the device is set up and not activated. REGEnLIFE RGn530 medical device will follow EC labelling if proven to be safe and effective
15897134|NCT03672461|Other|Yoga Practice Program|The 3-month yoga intervention will provide instruction and practice in a variety of yoga postures and techniques that have been selected by the study yoga expert consultants for their potential to improve bladder control and safety and feasibility for the target population.
15897135|NCT03672461|Other|Physical Conditioning Program|"The 3-month muscle stretching/strengthening intervention program (also referred to as the physical conditioning program) has been designed by the study physical therapist consultants."
15897136|NCT03672448|Other|Naturalistic observation|Naturalistic observation
15897137|NCT03672435|Drug|Topical Solution|proparacaine 0.5% eye drop
15897138|NCT03672422|Diagnostic Test|Blood sample|Six ml of blood will be collected from patients in an EDTA tube. 2 ml saliva samples in Oragene DNA collection kits
15897139|NCT03672422|Behavioral|Patient questionnaires|Questionnaires will be completed at the baseline and annual follow-up visits to collect data that will define the demographics of the pediatric ARP and CP cohort, describe risk factors, presence of family history of acute and chronic pancreatitis, diabetes and pancreatic cancer and assess disease burden and sequelae.
15897140|NCT03672422|Diagnostic Test|Saliva sample|2 ml saliva samples in Oragene DNA collection kits collected if no blood sample being collected.
15897141|NCT03672422|Diagnostic Test|Urine sample|50 ml of urine in collection container.
15897142|NCT03672409|Behavioral|Intervention in knowledge|"The knowledge intervention will be done through four group learning sessions with the objective of significantly increasing diabetes knowledge in health professionals.
~The learning sessions will be carried out weekly in a period of 4 weeks, with a duration of 60 minutes per session. In addition, two sessions will be held for the evaluation of pre and post intervention knowledge. The learning sessions consist in the diagnosis, evaluation, complications and comorbidities, pharmacological treatment and nutrition in type 2 diabetes."
15897143|NCT03672396|Behavioral|Home-based exercise|The intervention consists of aerobic and strength training ~3 times per week for 12 weeks with each session lasting 1 hour. The progressive aerobic exercise will involve walking that varies from from 15 to 30 minutes done 2-4 times per week at an intensity from 40% to 65% of heart rate reserve. Therabands elastic bands will be used to perform 12 to 15 repetitions per exercise. Once a participant can comfortably complete 15 repetitions for all prescribed sets, they will increase resistance by moving up to the next band. The training volume increased from 1 set per exercise on week 1 to 3 sets by week 12.
15897144|NCT03672383|Device|BAY987534|Form: cream; Route of Administration: topical; Frequency of Administration: twice daily ; Duration of Treatment: 4 weeks .
15897145|NCT03672357|Procedure|Laparoscopic liver resection|Laparoscopic hepatectomy
15897146|NCT03672357|Procedure|Open liver resection|Traditional open hepatectomy
15897147|NCT03672344|Device|BioStream Training|Gaze-controlled video game that leverages ABA principles of learning to target social skills deficits in children with autism spectrum disorder.
15897148|NCT03672344|Device|Alternative Game|Alternative Control Group Game
15897149|NCT03672331|Other|Mammogram|Every 1-4 years according to the national/regional guidelines or personalised schedule according to risk assessment
15897150|NCT03672331|Other|Ultrasound|As required according to the national/regional guidelines or personalised schedule according to risk assessment
15897151|NCT03672331|Other|MRI|As required according to the national/regional guidelines or personalised schedule according to risk assessment
15897400|NCT03670459|Other|Vestibular habituation exercises|Move from a sitting position to flat on the back
15897153|NCT03672318|Drug|CAR138 T Cells|"The MTD is defined as the dose at which approximately 0.20 of patients experience DLT dose escalation guided by the continual reassessment method (CRM).
~Six dose levels will be evaluated:
~Dose level 1: 5X10^6 cells/m^2 Dose level 2: 1X10^7 cells/m^2 Dose level 3: 2.5X10^7 cells/m^2 Dose level 4: 5X10^7 cells/m^2 Dose level 5: 1x10^8 cells/m^2 Dose level 6: 2x10^8 cells/m^2
~Six patients will be enrolled at the MTD to better characterize safety at that dose level.
~Cell Administration: CAR138 T cells will be given by intravenous injection over through either a peripheral or a central line.
~The lymphodepletion regimen will consist of intravenous cyclophosphamide 300 mg/m^2 and fludarabine 30 mg/m^2 given once daily for three days."
15897154|NCT03672305|Biological|c-Met/PD-L1 CAR-T cell injection|injection content:c-Met/PD-L1 CAR-T cell Infusion way:Steady intravenous drip in 15 to 30 minutes
15897155|NCT03672292|Drug|SCY-078|Oral tablets of SCY-078
15897156|NCT03672292|Drug|Voriconazole|Voriconazole IV vials or oral tablets
15897157|NCT03672292|Other|Oral Placebo Tablets|Oral Placebo Tablets matching SCY-078
15897158|NCT03672279|Diagnostic Test|CogCheck|Novel self-administered cognitive assessment tool
15897159|NCT03672253|Drug|CAR-T Re-treatment|Patients will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) or use their mononuclear cells that preserved in the laboratory for the production of CAR-T cells. After a pre-treatment lymphodepletion therapy, patients will receive the re-treatment of CAR-T therapy by intravenous injection.
15897160|NCT03672240|Drug|APL-1202|To assess the safety and pharmacokinetics of APL-1202 alone and in combination with Bacillus Calmette Guerin
15897161|NCT03672227|Behavioral|Mealtime Matters Training|This training will address common issues that Head Start teachers including how to deal with picky eaters, in addition to education about the nutritional needs of pre-school aged children.
15897162|NCT03672214|Procedure|Without placement of indwelling catheter|No placement of indwelling catheter prior to Caesarean section
15897163|NCT03672214|Procedure|With placement of indwelling catheter|Placement of indwelling catheter prior to Caesarean section
15897164|NCT03672201|Behavioral|Non-Pharmacological Intervention|The behavioural intervention will be a structured implementation of individualized activities to be followed and customized as per the needs of the participant.
15897165|NCT03672201|Other|Pharmacological Intervention|The medication algorithm provides recommendations to the treatment team about algorithmic treatment and assessments as per the ICP but ultimately the decision to prescribe any particular intervention will be the treatment team's decision and the recommendations of the research team for ICP arm will not be binding for the treatment team.
15897166|NCT03672188|Drug|VIR-2218|VIR-2218 given by subcutaneous injection
15897167|NCT03672188|Drug|Placebo|Sterile normal saline (0.9% NaCl) given by subcutaneous injection
15897168|NCT03672175|Drug|SAGE-217|Sage-217
15897169|NCT03672175|Drug|Placebo|Placebo
15897170|NCT03672162|Procedure|Total abdominal hysterectomy|Each drug group undergo elective total abdominal hysterectomy with the same general anesthesia
15897171|NCT03672149|Drug|Cefazolin|Mixing cefazolin into the CRRT solution(s) for delivery as a continuous infusion
15897172|NCT03672136|Drug|Anlotinib|Anlotinib is a novel multi-target tyrosine Kinase inhibitor that inhibits VEGFR2/3, FGFR1-4, PDGFD α/β, c-Kit and Ret.
15897173|NCT03672136|Other|Concurrent Chemoradiotherapy|Concurrent chemoradiotherapy as the current standard of care for unresectable stage III non small cell lung cancer patients
15897174|NCT03672110|Drug|Advagraf|intervention: different advagraf dosing in the study compared to the control arm, see above
15897175|NCT03672097|Drug|Prasugrel|Prasugrel, oral tablets, containing 3.75 mg per tablet
15897176|NCT03672071|Other|Ephedrine, Noradrenaline ,ephedrine+Noradrenaline)|If a 20% decrease in any hemodynamic parameter compared to their baseline levels is sustained, necessary interventions will be performed. In the case of hypotension, for all groups
15897177|NCT03672058|Other|Fitness tracker with goal setting and text message feedback|Participants provided with a Fitbit and this will also be linked to Fitabase. The physiotherapist will discuss the participants' baseline physical activity levels and individual patient centred short and long-term goals will be set with each participant. Every week participants will be contacted via text message by their CF physiotherapist. The physiotherapist will review their online data and will provide feedback and encouragement on their progress. Goals will be reviewed for each participant.
15897178|NCT03672058|Other|Fitness Tracker only|"Participants will be provided with the Fitbit and educated on how to use it. This will be linked to Fitabase, an online monitoring system for data collection purposes, with the consent of the participants. However no goal setting will be completed and no feedback will be provided to the participants on their physical activity levels"
15897179|NCT03672045|Drug|Carbetocin|carbetocin administered IV, over 1 minute following delivery of the fetal head
15897180|NCT03672032|Device|Fork-tip Needle|Fork-tip Needle will be used to obtain biopsy
15897181|NCT03672032|Device|Franseen Needle|Franseen Needle will be used to obtain biopsy
15897182|NCT03672019|Behavioral|FACT-Hep|Patient Reported Outcomes (PRO) assessments at baseline and at three time points post-procedure: 4 weeks (+/- 1 weeks), 12 weeks (+/- 2 weeks), and 6 months (+/- 2 weeks).
15897183|NCT03672006|Biological|alteplase (recombinant t-PA)|Medication administered to dwell in central venous catheter
15897184|NCT03672006|Drug|Heparin|Medication administered to dwell in central venous catheter
15897185|NCT03671993|Procedure|Electrical pudendal nerve stimulation|Four sacrococcygeal points were selected. Two 0.40Х100 mm needles were inserted perpendicularly to a depth of 80-90 mm 1 cm bilateral to the sacrococcygeal joint, to produce a sensation referred to the root of the penis (perineum) or the anus. Two needles of 0.40Х100 or 125mm were inserted obliquely toward the ischiorectal fossa to a depth of 90 to 110 mm about 1 cm bilateral to the tip of the coccyx, to produce a sensation referred to the root of the penis (or the perineum). Each two ipsilaterally needles were connected to one electrode from a G6805-2Multi-Purpose Health Device (Shanghai Medical Instruments High-Techno, Shanghai, China), with a frequency of 2.5 Hz and an intensity (45~55 mA). EPNS was given for 60 min a time, 3 sessions per week for 6 weeks.
15897254|NCT03671460|Biological|CD19 CAR-T cells|T cells purified from the PBMC of subjects, transduced with 4-1BB/CD3-ζ lentiviral vector, expanded in vitro for future administration.
15897255|NCT03671447|Other|ICU Usual Care|The control condition delivered at ICU is usual care.
15897401|NCT03670459|Other|Balance exercises|Weight Shift Forward and Back
15897186|NCT03671993|Procedure|Intravesical instillation|The patient should lie on a couch in a lithotomy position after urination. A catheter was passed through the urethra into the bladder and any residual urine should be drained. A mixture of the Cystistat (sodium hyaluronate, 50ml 40mg, Bioniche Teoranta, Ireland) solution and Lidocaine hydrochloride (40mg :20ml, Fangming Pharmacy company, Shangdong, China) is instilled through the catheter into the bladder. The catheter is then withdrawn leaving the mixture solution inside the bladder, retained for as long as possible, ideally at least 30 minutes. The instillation is once weekly for at 6 weeks.
15897187|NCT03671980|Other|My Medical record website|Website comprising patient records, blood and other test results, useful information on IBD, and messaging service to communicate with IBD team, plus home smartphone faecal calprotectin monitoring.
15897190|NCT03671954|Behavioral|Home Strengthening Exercises|The intervention group will perform unsupervised home strengthening exercises for the hip abductors in addition to standard physical therapy, while the control group will receive standard physical therapy alone.
15897191|NCT03671954|Other|Standard Physical Therapy|Physician determined standard of care for individual TKA patients.
15897192|NCT03671954|Other|Preoperative Assessments|"Assessments will include:
~TUG (timed up and go test) >12 sec indicates increased fall risk
~Tandem balance test < 10 sec indicates increased fall risk
~Sit to Stand test (age based norms)
~Knee Range Of Motion (ROM)
~Quadriceps and hamstring strength (MMT or hand held dynamometer)
~Lower Extremity Functional Score (LEFS questionnaire)"
15897193|NCT03671941|Drug|D578|D578 Tab.1T single oral administration under fasting condition
15897194|NCT03671941|Drug|CKD-357|CKD-357 Tab.1T single oral administration under fasting condition
15897195|NCT03671928|Other|additional blood tube|sampling of an additional tube at the usual blood test to determine the glicentin level
15897196|NCT03671928|Other|additional blood sample|for le group control, another blood sample is taken outside the usual care.
15897197|NCT03671915|Device|Continuous Glucose Monitoring|collection of glucose data
15897198|NCT03671915|Device|External Insulin Pump|Insulin delivery
15897199|NCT03671915|Device|Diabeloop Software (Model predictive control)|Diabeloop software embeds a regulation algorithm to automatically regulate the patient's glycaemia. It takes as input glycaemia value received every 5 minutes from the CGM and patient inputs related to meals and physical activities and it calculates the amount of insulin to be delivered. It sends this information to the pump that automatically delivers this quantity.
15897200|NCT03671915|Other|Remote monitoring (Telemedicine)|Remote follow up by care health providers team
15897201|NCT03671902|Device|Fluid shift|We are using lower body negative and positive pressure to create a fluid shift in the body. This study is investigating if there are changes in phonocardiographic parameters related to changes in blood volume caused by this fluid shift
15897202|NCT03671889|Device|Blood Brain Barrier (BBB) Disruption|Focal Ultrasound (FUS) involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct targets to induce BBB disruption.
15897203|NCT03671876|Device|Intervention plus therapy|Task oriented exercise plan to improve mobility for stroke patients
15897204|NCT03671863|Other|Invasive analysis (caryotype, CGH array)|Invasive analysis (caryotype, CGH array)
15897205|NCT03671863|Other|Prenatal management|Prenatal management
15897206|NCT03671850|Biological|VT-EBV-N|Epstein-barr virus human cytotoxic T lymphocytes (EBV-CTL)
15897207|NCT03671850|Other|Placebo|Peripheral blood mononuclear cell, PBMC
15897208|NCT03671837|Other|Oxygen|15 L/min O2
15897209|NCT03671837|Other|Air|15 L/min air
15897210|NCT03671824|Other|Measurements|Physiologic measurements including but not limited to thyromental distance, sternomental distance, Mallampati score, mouth opening, interincisor distance, and mandibular protrusion will be measured and recorded. All measurements are non invasive.
15897211|NCT03671811|Drug|Megestrol Acetate|Given PO
15897212|NCT03671811|Biological|Pterostilbene|Given PO
15897213|NCT03671785|Drug|PRIM-DJ2727|Twice filtered fecal microbiota product from three screened healthy donors will be lyophilized and encapsulated in enteric-coated capsules. Each dose of enteric coated capsules consists of 60 grams of stool and will be administered orally twice-weekly for 12 consecutive weeks
15897214|NCT03671785|Drug|Placebo oral capsule|Placebo capsule will be identical to PRIM-DJ2727 but will not contain intestinal bacteria. The placebo will consist of Lactose (spray-dried United States Pharmacopeia (USP) 64.385gm), food color, powdered Black, Brown, and Yellow in the enteric capsules. Placebo will be administered orally twice-weekly for 12 consecutive weeks
15897215|NCT03671759|Behavioral|Start: On Caffeine|In this two-day block, participants will be instructed to consume caffeine for one day and avoid caffeine the next day.
15897216|NCT03671759|Behavioral|Start: Off Caffeine|In this two-day block, participants will be instructed to avoid caffeine for one day and consume caffeine the next day.
15897217|NCT03671746|Drug|Ketorolac|Participants will receive Ketorolac at 30 mg IV every 6 hours for their first 5 days of hospitalization
15897218|NCT03671746|Drug|Saline Solution|Participants will receive 10 ml of saline solution IV every 6 hours for their first 5 days of hospitalization
15897219|NCT03671733|Drug|Liraglutide|The treatment of Liraglutide lasted three months,During the first week: 0.6mg per day, subcutaneous injection;During the second week: 1.2mg per day, subcutaneous injection; From third week onwards, 1.8mg per day, subcutaneous injection.
15897220|NCT03671733|Drug|Exenatide|10mcg once a day for 4 weeks increased to 10mcg twice a day for 8 weeks.
15897221|NCT03671733|Drug|Exenatide Microspheres for Injection|Exenatide 2 mg injection once weekly for 12 weeks.
15897222|NCT03671720|Biological|personalized DC vaccine|personalized vaccine comprised of autologous dendritic cells (DC) loaded in vitro with lysate from autologous tumor cells, administered intranodally on day 1,8,15, with a combination of oral cyclophosphamide (50mg) every day except the day of vaccine administrations.Cycles are repeated every 21 days. Treatment is continued until disease progression or exhaustion of vaccine supply, whichever comes first.
15897256|NCT03671447|Behavioral|Tele-ICU|The experimental complex intervention ERIC consists of daily tele-medicine based rounds at ICU. Tele-ICU is implemented after a blended learning program for ICU staff which will be completed prior to the site's crossover.
15897454|NCT03669965|Drug|Ruxolitinib|Ruxolitinib per approved prescribing label
15897223|NCT03671707|Behavioral|Brief AWARD advice|"Subject will receive brief, face-to-face counselling following a structured AWARD model at baseline :
~Ask: smokers will be asked about their smoking behaviour
~Warn about the harms of smoking using a leaflet which contain information about harms of secondhand smoke to women, fetus and infant, motivational messages to quit and smoking cessation services.
~Advise to quit or reduce their smoking and use the provided 1-week nicotine replace therapy sample as soon as possible
~Refer smokers to smoking cessation services if they agree.
~Do-it-again: repeat the AWARD advise through telephone boosters at 2-week and 4-week after baseline"
15897224|NCT03671707|Drug|Nicotine replacement therapy sampling|Subjects will receive 1-week supply of free nicotine patch or gum with dosage based on participants' number of cigarette per day. An information card containing reminders of nicotine replacement therapy use and actions to handle potential side effects will be provided.
15897225|NCT03671707|Behavioral|Active referral|Subjects will be encouraged to select and access a smoking cessation services in Hong Kong. If the subjects agree, their contact information will be sent to the smoking cessation service providers for further arrangement.
15897226|NCT03671707|Behavioral|Very brief advice|Subjects will receive general advice to quit
15897227|NCT03671707|Behavioral|Leaflet|Subjects will receive a standard leaflet on perinatal smoking by Department of Health
15897228|NCT03671694|Procedure|Erbium-YAG laser vaginal treatment|Erbium-YAG laser vaginal treatment
15897229|NCT03671681|Behavioral|Mindfulness|The experimental group will receive education, will be prescribed prophylaxis and will attend Mindfulness-based therapy sessions. The MINDFULNESS therapy consists in 6 weekly sessions, 45 minutes each. The main focus of the six mindfulness session will be the following: 1) introduction and meaning; 2) Focus on breath; 3) posture and body awareness; 4) meditation of sounds; 5) Guided imagery; 6) acceptance and awareness. During training, patients will be invited to close their eyes, assume a relaxed position, focus on their breathing and on the present to enhance awareness of current mind and body sensations. Patients will be trained in small groups (5-7 patients each) and guided by a specifically trained therapist. They will be educated to practice at home according to the instructions given by the therapist during the sessions.
15897230|NCT03671681|Drug|Prophylactic|Control group will receive education on the use of pharmacological compounds for acute treatment and on healthy lifestyle habits (e.g. adequate sleep/wake pattern, eating and hydration, physical activity, avoidance of triggers) and will be prescribed prophylactic medications. The preventive compound will be chosen on the basis of clinical profile among the following categories: neuromodulators (e.g. topiramate or valproate), antidepressant (e.g. tricyclics or SSRIs) or others, e.g. beta-blockers.
15897231|NCT03671668|Other|titanium bases using intra oral luting cement technique|comparing between screw retained prosthesis constructed on transmucosal abutments versus titanium bases in terms of crestal bone loss and patient satisfaction
15897232|NCT03671655|Device|Drug-eluting stent|Drug eluting stent which are nitinol stent coated with Paclitaxel drug
15897233|NCT03671655|Device|Bare metal stent|Bare metal stent is Nitinol alloy self expandable stent. Other Names: Bare metal stent Nitinol stent SMART Stent Viabahn stent
15897234|NCT03671642|Device|Q-ICG|Quantitative perfusion assessment with indocyanine green on a touch screen tablet
15897235|NCT03671642|Procedure|White light perfusion assessment|Traditional visual perfusion assessment in white light
15897236|NCT03671642|Procedure|Fluorescence angiography|Perfusion assessment with fluorescence angiography - without quantification
15897237|NCT03671629|Other|Enhanced clinical pharmacist service|The intervention includes regular medical chart reviews, multiple patient interviews and, if needed, collaboration with the primary care physician.
15897238|NCT03671616|Biological|IPV-Al SSI|IPV-Al contains the reduced dose of IPV to be administered intramuscularly to the anterolateral of the right thigh. A single dose of the IPV-Al SSI will be given to infants age 15-18 months.
15897239|NCT03671603|Drug|Iodixanol|Iodixanol 270 mgI/ml or 320 mg I/ml injection will be administered as part of clinical practice according to the judgment of the site with regard to medical need.
15897240|NCT03671590|Drug|TG-1701|Oral daily dose
15897241|NCT03671590|Drug|Umbralisib|Oral Daily Dose
15897242|NCT03671590|Biological|Ublituximab|Ublituximab at a fixed IV infusion on specific Days, followed by maintenance infusions
15897243|NCT03671577|Behavioral|Building Closer Friendships|Intervention designed to build social support and reduce loneliness by giving participants skills to strengthen their relationships
15897244|NCT03671564|Drug|Milademetan|Milademetan, an MDM2 inhibitor, is provided in capsules for oral administration
15897245|NCT03671538|Drug|Anlotinib|Anlotinib 12mg qd on day 1 to 14 of a 21-day cycle
15897246|NCT03671538|Drug|pemetrexed|pemetrexed 500mg/m2 on day 1 of a 21-day cycle ;
15897247|NCT03671538|Drug|Cisplatin|Cisplatin 75mg/m2 on day 1 of a 21-day cycle ;
15897248|NCT03671525|Drug|Nimodipine|Subject will receive two 30mg capsules of nimodipine during study visit.
15897249|NCT03671525|Drug|Placebo oral capsule|Two coconut oil capsules that mimic the size and color of the nimodipine capsules
15897250|NCT03671512|Device|Periodontal Structure Repair (PSR)|Following local anesthesia, initial pocket preparation will be done by bur abrasion utilizing specially designed burs to plane the root surface and remove the inner lining of the pocket. Following bur abrasion, thin strips of gauze sponge are placed into the created space. After removing the gauze strips, PSR is inserted to fill the spaces beginning at the pocket bottom. The final step is placing a layer of cyanoacrylate on both the gingival margin and tooth supragingivally.
15897251|NCT03671512|Device|Standard Root Planing|Ultrasonics and hand instruments are used to remove any subgingival deposits on the roots. Standard instruments and standard application are used. Visual or instrument tactile inspection is used to verify the roots are hard-smooth and have been adequately cleaned.
15897252|NCT03671499|Behavioral|Social Cognitive Theory based text messages|Participants receive daily text messages and bi-weekly newsletters with information about reducing sitting behavior and increasing physical activity.
15897253|NCT03671473|Device|Extracorporeal shock wave|Shock waves are defined a sequence of acoustic pulse characterized by a high peak pressure (100 MPa), fast pressure rise (< 10 ns) and short duration (10 μs). Different studies and clinical experiments have demonstrated the efficacy of shock waves in the treatment of musculoskeletal system such as chronic tendinopathies or hypertrophic pseudoarthrosis.
15897329|NCT03670953|Drug|IR CD-LD|Active comparator - IR CD-LD
15897259|NCT03671421|Procedure|ACL reconstruction - graft choice|Use of 3 different ipsilateral autograft options
15897260|NCT03671408|Other|clinical measurements|only clinical parameters were recorded
15897261|NCT03671382|Behavioral|Communication Training Program and Patient Prompt Sheet|The intervention being delivered is a two-component intervent. First component is the Oncologist Communication Skills Training Program. This is an e-learning module teaching oncologists to recognize and respond to patient/caregiver distress, provide information including prognosis and discuss goals of care. The second component is a patient prompt sheet which will be administered to three patients of intervention arm oncologists in the waiting area at least 30 minutes before their consultation. The sheet includes structured questions for patients to ask the oncologist about diagnosis and prognosis and will prompt patients to label and express their emotions in a direct manner.
15897262|NCT03671369|Other|Safety data collection (following routine vaccination) by a continuous surveillance method.|"This study assesses the safety of GSK Biologicals' Human papillomavirus (HPV) vaccine in terms of frequency and intensity of adverse events (AEs) and serious adverse events (SAEs) when administered routinely in male and female subjects aged between 9 and 25 years, according to the approved Prescribing Information in Korea.
~All AEs reported during the 30-day post-vaccination follow-up period (Day 1 to Day 30) and all SAEs reported through the study period from dose 1 up to 30 days after the last dose administered during the post-marketing surveillance (PMS) will be collected as part of safety data in this PMS."
15897263|NCT03671356|Other|risk score|risk score
15897264|NCT03671343|Behavioral|Physical rehabilitation|It will benefit from an initial and final geriatric assessment, an initial dietary balance and a personalized treatment in physical activities adapted for 3 months by an Educator in Adapted Physical Activities.
15897265|NCT03671330|Drug|Ribociclib Placebo|Film-coated tablets for oral use (200 mg x 3) form Day 1 of 21 of each 28 day cycle.
15897266|NCT03671330|Drug|Ribociclib|Film-coated tablets for oral use (200 mg x 3) form Day 1 of 21 of each 28 day cycle.
15897267|NCT03671330|Drug|NSAI: Letrozole or Anastrazole|"Letrozole: Tablets for oral use, 2.5mg daily (all days of every cycle without interruption).
~Anastrazole: Tablets for oral use, 1mg daily (all days of every cycle without interruption) For Premenopausal cohort, it is the investigators choice for NSAI based on patients past history.
~For postmenopausal and PK cohorts, all patients will be on Letrozole."
15897268|NCT03671330|Drug|Letrozole|Letrozole: Tablets for oral use, 2.5mg daily (all days of every cycle without interruption).
15897269|NCT03671330|Drug|Goserelin|Subcutaneous implant, 3.6mg on Day 1 of each 28 day cycle
15897270|NCT03671317|Behavioral|Medical Clowning|This arm will receive a medical clowning intervention in addition to pre and post surveys about the blood draw process.
15897271|NCT03671304|Device|Fitbit Versa|"Participants will receive a Fitbit Versa and instructions on its use. Participants will be asked to wear the device for eight weeks, removing it only for charging and when engaging in activities in which the device could be submerged in water (bathing, swimming, etc.).
~At enrollment, participants will indicate a preferred time to receive affective framing messages and EMA prompts (morning), and intention planning prompts (evenings). Participants will receive affective framing messages and intention planning prompts on a randomized schedule, such that participants will receive each message type on 50% of days."
15897272|NCT03671291|Behavioral|self-administrated questionnaire|Persons who the biological parameters or past screening show that they were recently infected with HIV cf. eligibility criteria, will, after obtaining his consent, answer a series of questions through a self-administrated questionnaire that will take approximately 40 minutes.
15897273|NCT03671278|Other|STarT Back Screening Tool Approach|Patients classified as low risk of persistent pain will be educated about their condition and how to manage their back pain by targeting modifiable prognostic factors. Patients classified as medium risk will receive evidence-based physical therapy. Patients classified as high risk will receive evidence-based physical therapy as well as individualized psychological intervention.
15897274|NCT03671265|Drug|SHR-1210|SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.
15897275|NCT03671265|Radiation|IMRT or VMAT|The IMRT or VMAT technique was used in our study.
15897276|NCT03671265|Drug|Apatinib|Apatinib is a small molecule tyrosine kinase inhibitor targeting vascular endothelial growth factor receptor-2.
15897277|NCT03671252|Drug|FOLFOXIRI|Irinotecan165 mg/m2、Oxaliplatin85 mg/m2、Left-calcium leucovorin 200mg/㎡，Intravenous infusion，first day. Then, 5-FU 1600 mg/m2/d×2 continuous intravenous infusion（total 3200 mg/m2，infusion 46 hours）in the next two days. Repeat every 14 days.
15897278|NCT03671252|Drug|XELOX|XELOX consisting of 130 mg/m2 oxaliplatin administered intravenously on day 1 and 1,000 mg/m2 capecitabine administered orally twice daily on days 1-14 for a 3-week cycle.
15897279|NCT03671252|Other|Chemoradiotherapy|"Chemotherapy: oral capecitabine（1650 mg/m2）twice daily during radiotherapy without weekend breaks.
~Radiation: Radiation therapy is administered via intensity-modulated radiation therapy (IMRT) with a linear accelerator, 6MV-X ray. The patients are scheduled to receive a GTV expanding 6mm to form PTV1 and CTV expanding 6mm to form PTV2. The dose of PTV1 is 50Gy/25 times for 35 days and the dose of PTV2 is 45Gy/25 times for 35 days. Patients were treated in consecutive days per week for a total of 5 weeks."
15897280|NCT03671252|Procedure|TME operation|TME operation
15897281|NCT03671252|Procedure|efficacy evaluation|chest/ abdominal CT、pelvic nuclear magnetic resonanceimaging、transrectal ultrasonography
15897282|NCT03671239|Behavioral|Placebo rectal insert|Participants will be instructed to insert in the rectum a placebo insert prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI. Furthermore, if no RAI activity occurs at all in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI.
15897283|NCT03671239|Behavioral|Placebo rectal suppository|Participants will be instructed to insert in the rectum a placebo suppository prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI. Furthermore, if no RAI activity occurs at all in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI.
15897284|NCT03671239|Behavioral|Placebo rectal douche|Participants will be instructed to insert in the rectum a placebo douche (enema bottle with approximately 120 mL of clean tap water or bottled water) prior to RAI. If a dose is missed, participants will be instructed to wait to take a dose at the next occurrence of RAI, or if no other RAI activity occurs in that 7-day period, to take a dose in the absence of RAI. Furthermore, if no RAI activity occurs at all in a given 7-day period, participants will be instructed to take a dose on the seventh day in the absence of RAI.
15897285|NCT03671226|Other|Questionnaire Administration|Given questionnaire
15897286|NCT03671213|Device|Calypso Knee System|The Calypso Knee System is an extra-capsular knee implant designed to fill the therapeutic gap between conservative care and more invasive surgical interventions for knee osteoarthritis.
15897287|NCT03671187|Other|Exercise|8 week exercise program
15897288|NCT03671174|Drug|Prednisone|10mg once daily orally
15897289|NCT03671174|Drug|Hydroxychloroquine|100mg to 200mg twice daily orally
15897290|NCT03671174|Drug|Aspirin|50mg once daily orally
15897291|NCT03671174|Drug|low molecular weight heparin|Enoxaparin 40mg once daily subcutaneous or dalteparin 5000IU once daily subcutaneous or nadroparin calcium 4100U once daily subcutaneous
15897292|NCT03671161|Device|Insulin Pump and flash glucose monitoring|Adults with type 1 diabetes, HbA1c >9% (75 mmol/mol), multi daily insulin injections ( MDI) and who perform less than 2 SMBG /day. Patients will be switched to insulin pump and start a FGM system (Free Style Libre®) during 6 months.
15897293|NCT03671148|Biological|placebo for rizankizumab|Placebo for risankizumab administered by subcutaneous (SC) injection
15897294|NCT03671148|Biological|risankizumab|Risankizumab administered by subcutaneous (SC) injection
15897295|NCT03671135|Other|TCA Intrastromal Inlay|Anterior surface of Bowmans Layer Corneal Optical Correction Inlay
15897296|NCT03671122|Diagnostic Test|Cardiac imaging in the PREFERS and CABG PREFERS cohorts|performed at baseline and after 1 year
15897297|NCT03671122|Other|Biomarker analysis in the PREFERS and CABG PREFERS chorts|blood samples will be taken for biomarker analysis at baseline and after 1 year
15897298|NCT03671122|Procedure|Cardiac biopsies in the CABG PREFERS cohort|myocardial biopsies from the right trium the left and right ventricles will be taken during elective CABG
15897299|NCT03671109|Drug|Dihydroartemisinin-piperaquine (DHA-PPQ)|Following physical examination, recruited women with more than 13 weeks of gestational age will receive IPTp-DHA-PPQ under supervision
15897300|NCT03671109|Drug|Placebo Oral Tablet|Following physical examination, recruited women with more than 13 weeks of gestational age will receive IPTp-Placebo under supervision
15897301|NCT03671096|Other|Intrastromal TCA Inlay|An intrastromal inlay that will be provided to correct the required hyperopic correction
15897302|NCT03671083|Device|BrainScope Ahead 300iP|The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT5), Electrophysiological Function; Neurocognitive Performance Assessment, Ocular Motor Assessment. BrainScope Ahead 300iP will be used to perform EEG and Cognitive assessments.
15897303|NCT03671070|Drug|Epinephrine|IV Low dose Boluses
15897304|NCT03671070|Drug|Traditional management of shock|"Initial resuscitation: Push boluses of 20 cc/kg isotonic saline or colloid up to and over 60 cc/kg until perfusion improves or unless rales or hepatomegaly develop
~Fluid refractory shock: Begin inotrope IV/IO. Use atropine/ketamine IV/IO/IM to obtain central access and airway if needed. Reverse cold shock by titrating central dopamine or, if resistant, titrate central epinephrine. Reverse warm shock by titrating central norepinephrine.
~Catecholamine resistant shock: Begin hydrocortisone if at risk for absolute adrenal insufficiency."
15897305|NCT03671057|Device|HospiAvontuur|To be included in the study children should play the game at least one time together with one parent
15897306|NCT03671057|Drug|Midazolam|current practice in Jessa
15897307|NCT03671044|Drug|Nanosomal Docetaxel Lipid Suspension (75 mg/m2)|Each vial containing lyophilized Docetaxel lipid powder, equivalent to 20 mg or 80 mg of anhydrous Docetaxel.
15897308|NCT03671044|Drug|Nanosomal Docetaxel Lipid Suspension (100 mg/m2)|Each vial containing lyophilized Docetaxel lipid powder, equivalent to 20 mg or 80 mg of anhydrous Docetaxel.
15897309|NCT03671044|Drug|Taxotere® (100 mg/m2)|Docetaxel Injection Concentrate; 20 mg/0.5 mL
15897310|NCT03671031|Procedure|isolated roux loop|Isolated roux loop reconstruction following pancreaticoduodenectomy
15897311|NCT03671031|Procedure|single loop|Conventional single loop reconstruction following pancreaticoduodenectomy
15897312|NCT03671018|Drug|Mosunetuzumab (IV)|Participants will receive intravenous (IV) mosunetuzumab.
15897313|NCT03671018|Drug|Mosunetuzumab (SC)|Participants will receive subcutaneous (SC) mosunetuzumab.
15897314|NCT03671018|Drug|Polatuzumab vedotin|Participants will receive IV polatuzumab vedotin.
15897315|NCT03671018|Drug|Tocilizumab|Participants will receive IV tocilizumab as needed.
15897316|NCT03671005|Behavioral|Mindfulness-based group therapy|see above
15897317|NCT03671005|Other|Treatment as usual|see above
15897318|NCT03670992|Procedure|duodenal-pancreatectomy|surgical removal of metastatic repetitions in pancreas and/or other distal sites
15897319|NCT03670979|Procedure|bone swaging|osseous wall pedicle was placed to treat the infrabony defect by autogrnous bone
15897320|NCT03670966|Biological|Astatine At 211 Anti-CD45 Monoclonal Antibody BC8-B10|Given via infusion
15897321|NCT03670966|Drug|Cyclophosphamide|Given IV
15897322|NCT03670966|Radiation|Total-Body Irradiation|Undergo TBI
15897323|NCT03670966|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo PBSC transplantation
15897324|NCT03670966|Procedure|Bone Marrow Transplantation|Undergo bone marrow transplant
15897325|NCT03670966|Drug|Mycophenolate Mofetil|Given IV or PO
15897326|NCT03670966|Biological|Recombinant Granulocyte Colony-Stimulating Factor|Given IV or SC
15897327|NCT03670966|Drug|Fludarabine Phosphate|Given IV
15897328|NCT03670966|Drug|Tacrolimus|Given IV or PO
15897333|NCT03670927|Other|Environmental, occupational and lifestyle-related exposures|A standardized questionnaire will be administered by a trained interviewer in order to gather information about occupational and residential history, demographic and socioeconomic characteristics and lifestyle factors. At the end of the interview, a saliva sample will be systematically proposed
15897334|NCT03670914|Diagnostic Test|WatchPAT 200|The WatchPAT200 device has been approved by the Food and Drug Administration (FDA) for testing sleep related disorders in patients ages 17 and older. They are widely used with thousands of studies performed in the United States to validate the devices accuracy and efficacy. It is also routinely used in many other countries. The devices are not currently being used for patients who are currently taking narcotic medications at Kaiser Permanente. Therefore, we are asking patients to simultaneously wear this device during an in-lab study, so we can test how effective and accurate the WatchPAT 200 is in diagnosing sleep breathing disorders in patients on narcotic medications.
15897335|NCT03670901|Biological|JHL1101|JHL1101, 100mg/10mL
15897336|NCT03670901|Biological|MabThera|Rituximab, 100mg/10mL
15897337|NCT03670888|Biological|JHL1101|100 mg/10 mL solution in a single-use vial
15897338|NCT03670888|Biological|Rituximab|100 mg/10 mL solution in a single-use vial
15897339|NCT03670875|Dietary Supplement|Agave inulin|Will be provided in dehydrated apple cubes
15897340|NCT03670875|Dietary Supplement|Curcumin|Will be provided in capsules
15897341|NCT03670875|Dietary Supplement|O3FA|Will be provided in capsules
15897342|NCT03670875|Behavioral|Control|Dietary recommendations to ingest 1600 calories per day. Exercise: 30 minutes each day, al least 5 days a week (caloric consumption 150-200 kcal per day)
15897343|NCT03670862|Other|CT|Non-contrast computed tomography , computed tomography angiography, computed tomography perfusion imaging
15897344|NCT03670849|Device|LapAR|LapAR system will be used for visualization of anatomy prior to surgery starts
15897345|NCT03670836|Device|Dilapan|Dilapan-S® is a mechanical method for cervical ripening using rods made of a patented hydrogel Aquacryl, it is marketed in form of rods of 3 and 4 mm diameter. It is FDA approved for cervical ripening.
15897346|NCT03670836|Drug|Misoprostol|"25mcg of Misoprostol will be administered orally every 2 hours (maximum of 6 doses)
~Misoprostol is a prostaglandin E1 analog approved for treatment and prevention of gastric ulcers. The use of Misoprostol appears to be safe and effective for induction of labor when used in low dose."
15897347|NCT03670823|Device|SIEMENS PRISMA MRI|Collect data on brain activation from different methods
15897348|NCT03670810|Drug|Lasmiditan|Administered orally.
15897349|NCT03670810|Drug|Placebo|Administered orally.
15897350|NCT03670784|Other|No intervention|No intervention, epidemiological investigation
15897351|NCT03670771|Diagnostic Test|Harrahill method for measuring of intraabdominal pressure|IAP obtained by using patient own urine as the transducing medium. One clamps the Foley catheter just above the urine collection bag. The tubing is then held at a position of 30-40 cm above the symphysis pubis and the clamp is released. The IAP is indicated by the height (in cm) of the urine column from the pubic bone. The meniscus should show respiratory variations.
15897352|NCT03670758|Diagnostic Test|Protein S activity|Intravenous blood sample
15897355|NCT03670732|Other|continuous positive airway pressure|Continuous positive airway pressure is applied for 12 hours at a mean airway pressure that is the same as the subject was receiving prior to entry into the study
15897356|NCT03670732|Other|nasal intermittent positive pressure ventilation|NIPPV is applied for 12 hours at a mean airway pressure that is the same as the subject was receiving prior to entry into the study
15897357|NCT03670719|Other|Manual Therapy and Exercise|Combination of physiotherapy (manual therapy) techniques and exercises for the cervical spine
15897358|NCT03670719|Other|Exercise|Exercises for the cervical spine
15897359|NCT03670706|Behavioral|Exercise|Package of care
15897360|NCT03670706|Other|analgesic optimisation|optimisation
15897361|NCT03670693|Diagnostic Test|Muscle strength and fatigue assessment|Measurement of maximum voluntary isometric contraction of the quadricep muscle on a cybex isokinetic dynomometer. This will be followed by a fatigue assessment where the torque decrement over 20 isokinetic knee extensions at a fixed angular velocity will be quantified to assess muscle fatigue
15897362|NCT03670693|Diagnostic Test|Dual-energy X-ray absorptiometry (DEXA scan)|Body composition will be assessed via DEXA scan (Lunar Prodigy, GE Medical Systems, Bucks, UK)
15897363|NCT03670693|Diagnostic Test|Supine cardiorespiratory fitness assessment|VO2 peak will be quantified during completion of a continuous, incremental exercise test performed in the supine position on an MR adapted stepper machine (Ergospect, Innsbruck Austria)
15897364|NCT03670693|Diagnostic Test|fMRI Exercise assessment|Measurement of cardiac output and, cerebral and regional perfusion using Blood-Oxygen-level-dependent (BOLD) measures and arterial spin-labelling (ASL)-MRI as well as fractional oxygen extraction using TRUST-MRI during supine exercise of the quadriceps with the MR compatible cardiostepper (Ergospect, Innsbruck, Austria) at 50% of relative VO2 peak as measured during the supine cardiorespiratory fitness assessment.
15897365|NCT03670693|Diagnostic Test|Muscle deconditioning assessment|Limb blood flow will be occluded with a cuff, whilst participants perform repeated plantar flexion exercise in a MRI scanner. This will drive PCr, (the available reserve of ATP) to zero. Once the cuff is removed, they will undergo non-invasive and well-established in vivo 31P magnetic resonance (31P MRS) measurements on the gastrocnemius to determine PCr re-synthesis rate during resting recovery.
15897366|NCT03670680|Device|Use of the Lina LibrataTM|Use of the Lina LibrataTM
15897367|NCT03670667|Other|Non-Interventional|Non-Interventional
15897368|NCT03670667|Other|Non-Interventional|Non-Interventional
15897369|NCT03670667|Other|Non-Interventional|Non-Interventional
15897455|NCT03669952|Other|None intervention|No interventions are realized, only observational study
15897370|NCT03670654|Other|Pilates|The Pilates exercises will be performed in 12 weeks with 40-minute sessions, three times a week: 2 at ambulatory and 1 at home. Ambulatory sessions will be supervised by a physical therapist in non-consecutive days. Patients could be grouped in classes with a maximum of 4 subjects. The first two weeks will be spent learning the technique and, in the third week, patients will receive an exercise booklet for in-home training. Will be used the classical solo Pilates exercises, adapted for non-trained individuals. Before and after each session, patients will be evaluated in relation to expiratory peak flow, blood pressure, heart rate and asthma symptoms.
15897371|NCT03670654|Other|Muscle stretching|The muscle stretching exercises will be performed in 12 weeks with 40-minute sessions, three times a week: 2 at ambulatory and 1 at home. Ambulatory sessions will be supervised by a physical therapist in non-consecutive days. Patients could be grouped in classes with a maximum of 4 subjects. Patients will practice muscle stretching exercises for principal muscle groups, performed with 3 repetitions, 15 seconds sustain and 1 minute interval. Before and after each session, the patients will be evaluated in relation to expiratory peak flow, blood pressure, heart rate and asthma symptoms.
15897372|NCT03670641|Drug|Glargine|Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved.
15897373|NCT03670641|Drug|Lispro|Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved.
15897374|NCT03670641|Device|Dexcom G6|Dexcom G6 CGM will be used to guide daily insulin glargine and lispro dose titrations in participants with newly diagnosed type 2 diabetes. After 4 weeks of CGM and insulin therapy, insulin will be discontinued and participant's labs monitored every 3 months to determine if diabetes remission achieved.
15897375|NCT03670628|Device|Shockwave therapy|This is a prospective, randomized, clinical study aimed to evaluate the safety and efficacy of the two treatment schedules on symptomatic ED patients. The patients are randomized in a 2:1 ratio of active to sham treatment groups. Patients randomized to the treatment group will be instructed to stop any use of PDE5i for 4 weeks prior to first treatment session and refrain from using any other ED therapy option during the study. They will be instructed to undergo a PDE5i washout period of 4 weeks prior to treatment. After the washout period and before the first treatment session, patients will answer the IIEF-EF, SEP and EHS questionnaires for baseline evaluation. Penile Doppler ultrasound will be performed by the time of enrollment, at 1,3, 6, 9 and 12 months and after treatment.
15897376|NCT03670615|Other|tDCS|All study participants randomized to tDCS will receive active tDCS.
15897377|NCT03670615|Other|Exercise|Participants will exercise at TRI according to an individualized exercise prescription.
15897378|NCT03670615|Other|Exercise Education|Exercise education/ treatment as usual will include routine advice about physical activity for older adults.
15897379|NCT03670615|Other|Sham tDCS|The same procedure for tDCS will be used for the sham condition, except without active current.
15897380|NCT03670602|Behavioral|Episodic Future Thinking (EFT)|Participants will practice using these cues when making decisions about health choices. Participants will implement EFT while using The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, resetting rewarding mechanisms by reducing need for immediate gratification, finding behavioral substitutes for highly reinforcing food.
15897381|NCT03670602|Behavioral|Control Thinking|Participants may see non-future cues that do not require prospection while using The Traffic Light Diet, The Traffic Light Activity Program, and a variety of behavioral techniques including stimulus control, self-monitoring, goal setting, problem solving, resetting rewarding mechanisms by reducing need for immediate gratification, finding behavioral substitutes for highly reinforcing food.
15897382|NCT03670589|Radiation|Radiosurgery gammaknife|This procedure use intense gamma ray, which are concentrated to the precise volume of the tumor that used to stop the progression of the tumor
15897383|NCT03670589|Procedure|Microsurgery resection|Classical surgical approach with oto-neurosurgery procedures
15897384|NCT03670576|Procedure|Optional Bronchoscopy|Patients can decide to have an optional bronchoscopy so that samples can be taken for research up to three months from baseline.
15897385|NCT03670576|Other|Quality of Life Questionnaires|MRC Dyspnoea, SPARC, KBILD and EQ-5D-5L will be administered at baseline, 3 months, 12 months and 24 months,
15897386|NCT03670576|Other|Blood Samples for Biomarkers|a 40ml research blood sample to be taken at baseline, 3 months, 12 months and 24 months.
15897387|NCT03670576|Other|Home Hand Held Spirometry|Patients will download an app and are given a small hand held device to record their own spirometry at home. This is blinded for the first three months of the study and then requested a week before and a week after the three follow up points (3m, 12m, 24m)
15897388|NCT03670563|Other|Short foot exercise protocol|Exercises that target intrinsic foot muscles
15897389|NCT03670563|Other|Short foot exercise plus NMES|Exercises that target intrinsic foot muscles supplemented by NMES for muscle re-education
15897390|NCT03670550|Device|Ossur Rebound ACL Brace|ACL-reconstruction patients will be issued an Ossur Rebound ACL Brace at the time of enrollment in the study, prior to surgery. They will use this brace throughout their rehab and physical therapy. The intervention (brace) will be applied only to the surgical limb.
15897391|NCT03670537|Diagnostic Test|Iron parameters|Serum iron, total iron binding capacity, TSAT (Fe/TIBC), serum ferritin
15897392|NCT03670524|Other|Greenness as a therapeutic intervention|Greenness to be used as a therapeutic intervention
15897393|NCT03670511|Other|sit-to-stand test|to sit and stand from a chair
15897394|NCT03670511|Other|six minute walking test|to walk for six minutes
15897395|NCT03670498|Device|4 channel Electrical Stimulation Device|electrical stimulation at muscles which related with deglutition
15897396|NCT03670498|Device|2 channel Electrical Stimulation Device|electrical stimulation at muscles which related with deglutition
15897397|NCT03670485|Device|4 channel Electrical Stimulation Device|electrical stimulation at muscles which related with deglutition
15897398|NCT03670472|Other|smear of nasal fossae|1 smear of nasal fossae during a usual or scheduled visit
15897399|NCT03670459|Other|Cawthorne Cooksey exercises|Eye movements and head movements
15897402|NCT03670446|Other|Pharmacists' intervention|"Medication education: When the patient is enrolled in the intervention group, pharmacists issue an education manual to give a medical education which contains the reasons for using NOACs, the characteristics of the drug, the precautions, and how to monitor the efficacy. Pharmacists re-educate through telephone or clinic during follow-up.
~Establish a medical record and remind their follow-up by message, phone every 2 weeks.
~Follow-up in the 4th week and 8th week : Pharmacists recommend patients for drug therapy optimization after conducting a full pharmacotherapy review of each patient's medication regimen and remind them to test urinary occult blood every 1-3 months, detect hemoglobin and liver/kidney function every 3-6 months."
15897403|NCT03670433|Other|Cost analysis of medication reconciliation|"The MR at entry is performed by the pharmaceutical team as soon as possible after admission. The sequences of the medical conciliation are attributed to the health professionals according to the recommendations of the French National Authority for Health (HAS).
~The MR at the discharge is carried out in collaboration between the pharmaceutical and medical teams. It associates the patient through pharmaceutical interview and relies on the sharing of informations related to the patient's medical treatments. These informations are synthesized in an output conciliation sheet transmitted in real time by secure messaging to the attending physician and the dispensing pharmacist. In parallel, the liaison letter and the patient discharge order are generated in order to guarantee a perfect homogeneity between all the documents transmitted at the patient's exit. MR sequences are attributed to health professionals according to the recommendations of the HAS."
15897404|NCT03670420|Other|Medical honey|The investigators use Medihoney®, a medical honey released by the DermaSciences.
15897405|NCT03670407|Procedure|Ovarian tissue fragmentation|Unilateral ovariectomy, ovarian tissue in vitro fragmentation and reimplantation.
15897406|NCT03670394|Diagnostic Test|Capillary Refill|We are measuring capillary refill to assess it's correlation with dehydration in children
15897407|NCT03670381|Other|Psychiatric diagnosis|
15897408|NCT03670368|Behavioral|Mentoring|The intervention will include one-on-one mentoring sessions held after school, focusing on coping, social relationships, and healthy lifestyles.
15897409|NCT03670368|Behavioral|Comparison group - written materials|Written materials from the mentoring sessions will be provided to those in the comparison group
15897412|NCT03670329|Device|URGO2875|Dressing
15897413|NCT03670316|Drug|Algorithm Treatment|Varenicline was selected as the first line of treatment for patients willing to take a medication twice per day and wanting cessation. Following varenicline, bupropion and then NRT are subsequent options. In terms of preference for NRT, nicotine patches would be the first option followed by lozenge, gum, inhaler, and nasal spray. The order of NRT within the algorithm is based upon patient familiarity and number of clinical trials supporting their use. Combination NRT (e.g., patch and lozenge) or adding NRT to varenicline or bupropion is offered to participants who have made an unsuccessful quit attempt with these medications in the past. If none of these medications are appropriate, then the participant is offered counseling only.
15897414|NCT03670316|Other|Quitline only|eTAU participants will complete the same algorithm questions but will not have this information sent to their provider, although their provider may elect to prescribe medication as part of standard of care. Participants will be referred to a quitline for behavioral support services for cessation.
15897415|NCT03670303|Behavioral|Educational intervention|"Educational intervention will be given by trained optometrists to participants (requiring spectacles) their parents and teachers. Duration of Intervention will be about one hours and it includes:
~Lectures on importance of spectacles use including visual materials such as pictures and videos.
~An interactive classroom based demonstration carried out by trained optometrist. Children will be asked to read from blackboard, written to be visible with 6/6 vision, while seated at a distance of 6m. After this children will be given their glasses and asked to read again. The purpose of this demonstration is to make children aware of their poor vision and of the potential impact of corrected VA.
~Posters
~Brochures"
15897416|NCT03670290|Procedure|Fascia iliaca compartment catheter|Patient will evaluate and if VAS score >3, catheter will be inserted and 30 ml bupivacaine 0.25% will be applied after admission. Dose will be repeated VAS>3 or patient enounce pain.
15897417|NCT03670290|Procedure|epidural catheter|Patient will evaluate and if VAS score >3, catheter will be inserted and 10 ml bupivacaine 0.25% will be applied after admission. Dose will be repeated VAS>3 or patient enounce pain.
15897418|NCT03670290|Procedure|patient controlled analgesia|Patient will evaluate and if VAS score >3, patient controlled analgesia pump will be set 1mg morphine/15 min lockout.
15897419|NCT03670264|Behavioral|Quitline Incentive|The incentive structure emphasizes engaging with the quitline, with an additional smaller payment for tobacco cessation. Each adolescent can receive compensation for enrolling in the quitline, for maintaining involvement in the quitline program (compensation per call for up to 5 calls), and, for those reporting abstinence, for submitting the cotinine swab and for confirmed quitting (negative cotinine swab).
15897420|NCT03670264|Behavioral|Tobacco Cessation Incentive|The incentive payment structure emphasizes quitting regardless of engagement with the quitline (though the quitline will be presented as a helpful tool). Each adolescent will receive compensation for enrolling in the Quitline and, for those reporting abstinence, for submitting the cotinine swab and for confirmed quitting (negative cotinine swab).
15897421|NCT03670264|Behavioral|Way to Health (WTH) Platform|The WTH platform is a web-based platform that sends reminder text messages to participants regarding study procedures and has has secure financial tracking and processing systems to manage participant payments, including the ability to track earnings and pay participants via a non-integrated payment system.
15897422|NCT03670264|Behavioral|Quitline Delivered Treatment|The quitline provides tobacco cessation treatment to individuals who enroll in treatment. This treatment includes 5 proactive counseling calls, each designed to help develop problem-solving and coping skills, secure social support, and plan for long-term abstinence. Participants can also call an 800 telephone number as needed for additional support between proactive calls.
15897423|NCT03670251|Procedure|Blood sampling|Blood sample of 10 mL by venipuncture and 0,4 mL by finger prick
15897491|NCT03669653|Procedure|Sham remote ischemic conditioning|Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 60 mm Hg. RIC will be conducted twice daily for 7 days.
15897424|NCT03670238|Device|Orogastric intubation|Patient was placed in Fowler position (45º) and intraoral infiltrative anesthesia was carried out with Lidocaine 2% (without vasoconstrictor) at gingival papilla in the vestibular-palatine direction. A polyurethane enteral tube (Medicone®, Cachoeirinha - Brazil) was inserted through the mouth and passed into de stomach, followed by fixation of the tube tip to a superior molar or premolar, in its palatine surface. For dental amarry it waas used a suture wire in stainless steel size 1.0
15897425|NCT03670238|Device|Nasogastric intubation|After nostril anesthesia with xylocaine gel, a polyurethane enteral tube was inserted through the nose and its tip was positioned in the gastric lumen, according to the nose-ear-xiphoid method. The tube was attached to the face using antiallergic adhesive tape.
15897426|NCT03670225|Device|Invia Motion Endure|NPWT Invia Motion Endure
15897427|NCT03670212|Drug|Yohimbine Hydrochloride|54mg of yohimbine powder was encapsulated in a generic opaque capsule and swallowed with water.
15897428|NCT03670212|Drug|Hydrocortisone|10mg hydrocortisone was encapsulated in a generic opaque capsule and swallowed with water.
15897429|NCT03670212|Drug|Lactose Monohydrate Powder|Lactose powder was encapsulated in generic opaque capsules identical to those used during the acute stress session. Lactose doses weighed the same as the acute stress session doses (54mg and 10mg, respectively).
15897430|NCT03670199|Other|Dietary advice|Nutritional status assessment Explanation of standard nutritional advices with an written explanation sheet
15897431|NCT03670199|Other|Physiotherapist intervention|Respiratory capacity Functional capacity
15897432|NCT03670199|Other|Dietary intervention|Nutritional status assessment Presentation of the Nutrimus booklet by the coordinating dietitian Establishment or adaptation of a nutritional support (prescription of nutritional supplements if necessary). Delivery and explanation of the preoperative nutritional counseling support
15897433|NCT03670199|Other|Intensify physiotherapist intervention|Respiratory capacity Functional capacity Tips adapted for physical activity and strengthening or maintenance of muscle mass Presentation of respiratory physiotherapy exercises to prevent postoperative bronchial congestion Nutrition and physical mobilization tips with the Nutrimus booklet
15897434|NCT03670186|Behavioral|High-Intensity Interval Training (HIIT)|Participants perform high-intensity interval training (HIIT) on a cycle ergometer. The HIIT protocol consists of a 3-minute warm-up at 50W, ten 60-second high-intensity cycling intervals interspersed with 90 seconds of active recovery at 30% of their peak power output and a 2-minute cool-down at 50W for a total of 17.5 minutes.
15897435|NCT03670173|Drug|Osalmid|Participants are initially given oral capsules with 0.5g tid osalmid daily for two weeks. Thereafter, the dosage will be increased by 0.25g tid every two weeks as tolerated by participants to a maximum daily dosage of 1.0g tid for up to one year.
15897436|NCT03670160|Drug|Phenobarbital|Phenobarbital loading dose 20 mg/kg in 2 divided doses, then 5 mg/kg/day divided every 12 hours. Phenobarbital dose will be adjusted to obtain desired trough of 25 to 30 mcg/mL. Levels will be obtained on Day 6 then weekly thereafter. Phenobarbital will be tapered over 4 weeks upon discharge from the hospital. The standardized taper is based the patient specific dose at the time of discharge.
15897437|NCT03670160|Drug|Clonidine|Clonidine 5 mcg/kg/day divided every 3 hours. Clonidine will be increased by 1.5 mcg/kg/day to achieve control of NAS symptoms based upon standardized scoring for neonatal abstinence syndrome. Clonidine will be weaned by 25% every 24 hours after successful discontinuation of oral morphine sulfate. Infants will not be discharged on clonidine.
15897438|NCT03670147|Device|PF-SCS programming|In a blinded fashion, the study physician will ask subjects to switch their PF-SCS to the LAP.
15897439|NCT03670134|Device|The Nvision VLE Imaging System|Volumetric laser Endomicroscopy (VLE) will be performed by using the Nvision VLE Imaging System (Nine Point Medical, MA) consists of an imaging console, monitor and optical probe. The optical probe is centered by a balloon (diameter: 14 mm, 17 mm, 20 mm; length: 6 cm) that is deployed through a diagnostic gastroscope's instrument channel. Imaging is performed by automatic helical pullback of the probe from the distal to the proximal end of the balloon over 90 seconds.
15897440|NCT03670121|Device|Bronchoscopic Thermal vapor ablation (BTVA)|Bronchoscopic vapor delivery to airway segment(s) targeted for treatment
15897441|NCT03670095|Drug|Lactose-free memantine|Lactose-free memantine tablet, 10 mg; orally as a single dose
15897442|NCT03670095|Drug|Memantine|Lactose-containing memantine tablet, 10 mg, orally as a single dose
15897443|NCT03670082|Drug|Lu AF35700|20 mg Lu AF35700 single oral dose
15897444|NCT03670082|Drug|Lu AF35700 iv|100 μg [14C]-Lu AF35700 (4.7 μCi/174 kBq) single intravenous micro-dose
15897445|NCT03670069|Drug|Itacitinib|Given PO
15897446|NCT03670069|Other|Laboratory Biomarker Analysis|Correlative studies
15897447|NCT03670056|Drug|Combination immunotherapy with Ipilimumab and Nivolumab|Patients will be treated with nivolumab 1 mg/kg and ipilimumab 3 mg/kg, starting on Day 1. Patients will receive 4 doses of each nivolumab and ipilimumab and then will receive nivolumab 240 mg starting week 13 (day 85) every 2 weeks until progression, unacceptable toxicity, withdrawal of consent, or the study ends, whichever occurs first.
15897448|NCT03670043|Drug|Psyllium powder|To evaluate whether Psyllium will alleviate diarrhea
15897449|NCT03670043|Drug|Metformin Extended Release Oral Tablet|Metformin Extended Release Oral Tablet is standard of care for diarrhea in patients taking metformin
15897450|NCT03670030|Drug|ABI-009|rapamycin protein-bound nanoparticles for injectable suspension (albumin bound)
15897452|NCT03669978|Procedure|Creation of a bone and arterial panorama using EndoNaut® software.|"The routine care procedure begins with staged injections of contrast medium to provide a map of the lesions. The lesions are then treated by angioplasty with or without stenting.
~New injections of contrast product are made to control the results of the treatment.
~As part of this pilot study, the assistive software and its interface will be linked and with the mobile C-arm X-ray system. Scopic images and angiograms will be retransmitted to be processed by the EndoNaut® software."
15897453|NCT03669965|Drug|KRT-232|KRT-232, administered by mouth
15897456|NCT03669939|Other|Communication Strategy|Communication Strategy The intervention consists of a handbook that refers to the CDC Guidelines with tools and communication strategies that the PCP can use when assessing their patients who are on opioids. The Handbook will have a description of the Ohm-app and the information the PCP can retrieve from the dashboard in their medical record. They will also be provided a template to use when seeing the patient to use as guide and as documentation.
15897457|NCT03669939|Other|Standard of Care|The standard information about the CDC Guidelines and no other information that is available through the study.
15897458|NCT03669926|Radiation|Digital Breast Tomosynthesis+synthetic mammography|Two-view tomosynthesis performed with GE Senographe Pristina.
15897459|NCT03669913|Other|Lessons on comprehensive sexuality education|Provision of 11 standardized lessons on comprehensive sexuality education based on international guidance on sexuality education by UNESCO
15897460|NCT03669900|Procedure|a minimally invasive surgery (SERI)|The SERI technique (as abbreviated to stand for simple, effective, rapid and inexpensive) was presented by several authors to be a minimally invasive technique since it presents with the same advantages as the percutaneous techniques with less tissue dissection and a need for only temporary hardware, meaning no instrumentation and surgery is performed under direct vision without fluoroscopy
15897461|NCT03669887|Behavioral|Lifestyle Modification Program|The intervention will consist of 5 individual face-to-face sessions at 2-weekly intervals with a dietitian with experience in lifestyle modification program, followed by monthly phone contact and smartphone text messages. All study participants in the intervention arm will also be arranged to meet with an exercise instructor at least once during the LMP on the same day as one of the dietitian appointment. Ongoing support from the exercise instructor will also be available by phone calls or emails.
15897462|NCT03669874|Device|Endoscopic fundoplication|"Endoscopic fundoplication is a less invasive alternative to the traditional surgical fundoplication.
~The MUSE device is similar to an endoscope, so the whole procedure can be done by a single operator. The device is composed of a shaft with a distal rigid part which is placed in the esophagus 3 cm proximal to the esophago-gastric junction containing a cartridge holding five B-shaped titanium surgical Staples and a tip which is retroflexed and contains an ultrasonic transducer which defines the correct tissue thickness for stapling the fundus against the esophagus. The device must be extracted to be reloaded with 5 more staples at a time for creation of a 180° anterior fundoplication."
15897463|NCT03669861|Drug|Abatacept|Subjects will receive weekly subcutaneous doses of abatacept (125mg) for 24 doses (24 weeks)
15897464|NCT03669848|Other|Pulse CO-oximetry|Measuring blood Carbon Monoxide levels with Pulse CO-oximetry (SpCO)
15897465|NCT03669835|Dietary Supplement|Mare milk supplement|Supplement consisting of sublimated mare's milk with single-dose 20 mg sachet. The supplement is dissolved in 36-27 degrees of Celsius water and taken 15-20 minutes before meal.
15897466|NCT03669835|Drug|Standard therapy|For hepatitis virus C genotype 1: sofosbuvir 400 mg + lepidavir 90 mg for 12 weeks OR sofosbuvir 400 mg + daclatasvir 60 mg for 12 weeks; For hepatitis virus C genotypes 2 and 3: sofosbuvir 400 mg + daclatasvir 60 mg for 12 weeks.
15897467|NCT03669822|Other|Standard of care|Care decisions driven by local physicians; this is an observational cohort.
15897468|NCT03669796|Dietary Supplement|Marine protein hydrolysate (mph)|Marine (Cod) protein hydrolysate
15897469|NCT03669796|Dietary Supplement|Control|Maltodextrin/Casein
15897470|NCT03669783|Drug|treatment Vincristin|1 x Vincristin 1,5mg/m² iv bolus day 1 in week 1,2,3,4,5,6
15897471|NCT03669783|Drug|treatment Actinomycin-D|1 x Actinomycin D 45µg/kg iv bolus day 1 in week 1, 3, 5
15897472|NCT03669783|Drug|treatment Doxorubicin|1 x Doxorubicin 50mg/m² 6h Infusion day 1 in week 1,5
15897473|NCT03669783|Drug|treatment Carboplatin|1 x Carboplatin 200 mg/m² 1h infusion day 1,2,3 in week 1,4
15897474|NCT03669783|Drug|Etoposide|1 x Etoposide 100mg/m² 1h infusion day 1,2,3 in week 1,4
15897475|NCT03669757|Drug|LEO 134310|Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
15897476|NCT03669757|Drug|LEO 134310|Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
15897477|NCT03669757|Drug|LEO 134310|Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
15897478|NCT03669757|Drug|LEO 134310|Active substance: LEO 134310 is a compound in development at LEO Pharma A/S
15897479|NCT03669757|Drug|LEO 134310 vehicle|Active substance: none
15897480|NCT03669757|Drug|0.1% betamethasone valerate ointment (class III steroid)|Active substance: betamethasone valerate
15897481|NCT03669744|Other|telephone survey|a telephone survey will be conducted at 21 patients with trigeminal neuralgia resistant to usual treatments, according to the ICHD-3β criteria treating by one or more trigeminal nerve blocks at the peri operative pain management center of Limoges University Hospital between 2014 and 2018.
15897482|NCT03669731|Other|food diary|This food diary is to be completed by the patient in the 3rd trimester of pregnancy, on 3 consecutive days and if possible including a weekend day. Finally, the investigator also prescribes a biological analysis: a urinary urea from a 24h diuresis to be collected in the 3rd trimester in a dedicated collector and given that same day.
15897483|NCT03669718|Biological|ISA101b|Every 3 weeks for a total of 3 times
15897484|NCT03669718|Drug|Cemiplimab|Every 3 weeks for up to 24 months
15897485|NCT03669718|Other|Placebo|Every 3 weeks for a total of 3 times
15897486|NCT03669705|Procedure|Omitting axillary surgery in early breast cancer|Before the Sentinel Node era all invasive breast cancer was recommended to have axillary dissection but after the introduction of national breast cancer screening this guideline statement was challenged by this national Swedish cohort.
15897487|NCT03669692|Behavioral|Caloric Restriction|Subjects will be trained to perform intermittent caloric restriction, based on an early time restricted feeding, with a 16/8 hour fasting / feeding schedule, respectively.
15897488|NCT03669692|Behavioral|Control|Subjects will receive diet and lifestyle recommendations from the Spanish Association of Urology, for symptoms secondary to HBP, without restriction in the meal schedule.
15897489|NCT03669679|Procedure|Breast reduction|breast reduction surgery for breast hypertrophy using either superomedial or inferior pedicle technique
15897490|NCT03669653|Procedure|Remote ischemic conditioning|Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 days.
15897494|NCT03669627|Biological|aTIV Primer|MF59-adjuvanted trivalent influenza virus primer: 2 doses (0.25mL) one month apart
15897495|NCT03669627|Biological|QIV Primer|Unadjuvanted quadrivalent influenza vaccine primer: 2 doses (0.5mL) one month apart
15897496|NCT03669627|Biological|aTIV Booster|MF59-adjuvanted influenza virus vaccine booster: 1 dose (0.25mL), year 2
15897497|NCT03669627|Biological|QIV Booster|Unadjuvanted quadrivalent influenza vaccine booster: 1 dose (0.5mL), year 2
15897498|NCT03669614|Drug|Inhaled AR-501|single and multiple ascending doses of inhaled AR-501
15897499|NCT03669614|Drug|Inhaled Placebo|single and multiple ascending doses of inhaled placebo
15897500|NCT03669601|Drug|AZD6738|A potent, selective inhibitor of the serine/threonine-specific protein kinase, ataxia telangiectasia and Rad3-related protein (ATR), with good selectivity against other phosphatidylinositol 3-kinase-related kinase (PIKK) family members.
15897501|NCT03669601|Drug|Gemcitabine|Nucleoside metabolic inhibitor.
15897502|NCT03669588|Biological|ARGX-113|Intravenous administration of ARGX-113
15897503|NCT03669588|Biological|Placebo|Intravenous administration of placebo
15897504|NCT03669575|Dietary Supplement|omega 7|Three weeks omega 7 fatty acid nutritional supplement, approximately 900 mg/day
15897505|NCT03669575|Dietary Supplement|Placebo|Three weeks placebo fatty acids approximately 900 mg/day which does not contain omega 7
15897506|NCT03669562|Drug|Alprostadil Liposome for Injection|intravenous infusion Alprostadil Liposome
15897507|NCT03669562|Drug|Placebo|intravenous infusion liposome control
15897508|NCT03669549|Drug|Nevanimibe hydrochloride|During the 16-week treatment period, all subjects will begin dosing with nevanimibe HCl 500 mg BID and be dose titrated to 1000 mg BID, 1500 mg BID, and 2000 mg BID as needed based on serum 17-OHP assessments every 4 weeks.
15897509|NCT03669523|Drug|Denosumab-nivolumab combination|"Denosumab: 120 mg every 4 weeks subcutaneously
~Nivolumab: 240mg intravenously on day 1 every 2 weeks"
15897510|NCT03669510|Other|computer guided IAN lateralization surgical technique|Tthe neurosensory alterations with computer guided inferior alveolar nerve lateralization versus non guided classic technique
15897511|NCT03669497|Radiation|Hypo fractionated whole breast radiotherapy|Hypo fractionated radiotherapy to the whole breast and SCF to a dose of 26 GY in 5 fractions with simultaneous integrated boost in advanced incurable breast cancer
15897512|NCT03669484|Drug|Remimazolam|Lyophilisate for preparation of solution for intravenous administration, 50 mg. Required to prepare a 50 ml syringe with the infusion solution at a concentration of 1 mg/ml (in accordance with guidance given in protocol)
15897513|NCT03669484|Drug|Propofol|Emulsion for infusion, 10 mg/mL in 20-mL glass vials
15897514|NCT03669484|Drug|Fentanyl|Solution for intravenous administration, 50 mg/mL. Used for anesthesia induction (at a dose of 2 mg/kg) and, if necessary, anesthesia maintenance (the dose was selected individually)
15897515|NCT03669484|Drug|Rocuronium bromide|Solution for intravenous administration, 10 mg/mL. Used for anesthesia induction (at a dose of 0.6-0.9 mg/kg) and, if necessary, anesthesia maintenance (the dose was selected individually)
15897516|NCT03669471|Other|Testing of performance|"The cross-sectional evaluation will involve assessment of:
~Hip muscle function
~Single leg jump performance
~Self-reported hip and groin function
~Evaluation of return to sport
~Evaluation of satisfaction regarding usual-care post-operative rehabilitation
~The exercise-based treatment will involve criteria-based physiotherapy aiming at improving muscle function around the hip and trunk."
15897517|NCT03669458|Device|Below the Knee peripheral intervention|Treatment of infrapopliteal disease using SPUR/DCB, SPUR only and DCB alone
15897518|NCT03669445|Drug|Ixazomib|21-day cycles induction and 28-day cycles consolidation
15897519|NCT03669445|Drug|Lenalidomide|21-day cycles induction and 28-day cycles consolidation and 28-day cycles maintenance therapy
15897520|NCT03669445|Drug|Dexamethasone|21-day cycles induction and 28-day cycles consolidation
15897521|NCT03669445|Drug|Daratumumab|21-day cycles induction and 28-day cycles consolidation
15897522|NCT03669432|Radiation|Intensity Modulated Radiotherapy|"The patient will receive adjuvant radiation therapy about 8-10 weeks after completion of initial surgery. The duration of this radiation therapy will be approximately 45 days.
~: The goal of the treatment plan would be to encompass the PTV subclinical disease with a dose of 54-60 Gy and the planned target volume (PTV) of the gross disease with 70-74 Gy while sparing as much of the aforesaid critical structures as possible.
~The maximum permissible point doses to the spinal cord will be limited to 46 Gy. IMRT planning and delivery will be carried out on the Tomotherapy Hi Art System."
15897523|NCT03669432|Procedure|Surgery alone|This intervention is of no interest
15897524|NCT03669419|Diagnostic Test|QoR 9 Questionnaire|The QoR-9 as established patient-centred outcome measure, which is validated in German language, is surveyed preoperatively, as well as on postoperative day 1 and 3 after non-cardiac surgery. Postoperative complications are evaluated using the Clavien-Dindo Score. A follow-up is intended after 6 months. Preoperative risk is estimated using the ASA (American Society of Anesthesiologists) and the POSPOM (Preoperative Score to predict postoperative mortality) score.
15897525|NCT03669406|Procedure|Autograft fat|autograft fat
15897526|NCT03669393|Drug|THR-317 8mg|3 intravitreal injections of THR-317 8mg, approximately 1 month apart
15897527|NCT03669367|Drug|Abatacept Injection|Abatacept subcutaneous in monotherapy 125 mg/week during the first year (12 months). Abtacept subcutaneus in monotherapy 125 mg/2weeks during the second year.
15897528|NCT03669367|Drug|hydroxycloroquina|oral hydroxycloroquina 5 mg/Kg/day for 2 years (0-48 months)
15897529|NCT03669341|Other|Deep Inspiration Breath Hold (DIBH)|human-based DIBH method with short-term breath-hold training
15897530|NCT03669341|Other|High Frequency Percussive Ventilation (HFPV)|device-based HFPV technique
15897531|NCT03669328|Procedure|locoregional anesthesia|Both groups received locoregional anesthesias
15897532|NCT03669315|Device|Transcranial Magnetic stimulation|Neuromodulation tool
15897533|NCT03669302|Other|Robotic gait training|Fifteen people with spinal cord injury will receive 20 daily sessions of robotic gait training. During assisted stepping, they will receive also non-invasive transspinal stimulation as a pulse train at 30 Hz during the stance phase of gait. Before and after training standardized clinical and neurophysiological tests will be used to assess recovery of sensorimotor function.
15897631|NCT03668561|Device|Caligaloc|15 days of wearing of the Caligaloc orthosis
15897534|NCT03669302|Device|Robotic gait training and low-frequency transspinal stimulation|Fifteen people with spinal cord injury will receive 20 daily sessions of robotic gait training. During assisted stepping, they will receive also non-invasive transspinal stimulation as a single pulse at 0.3 Hz during the stance phase of gait. Before and after training standardized clinical and neurophysiological tests will be used to assess recovery of sensorimotor function.
15897535|NCT03669302|Device|Robotic gait training and high-frequency transspinal stimulation|Fifteen people with spinal cord injury will receive 20 daily sessions of robotic gait training. During assisted stepping, they will receive also non-invasive transspinal stimulation as a pulse train at 30 Hz during the stance phase of gait. Before and after training standardized clinical and neurophysiological tests will be used to assess recovery of sensorimotor function.
15897536|NCT03669289|Other|enhanced model of primary care|The SCHOOL STARS model of care includes pre-visit planning, standardized visit content, post-visit care coordination, and coordination between primary care and school.
15897537|NCT03669263|Drug|Fentanyl buccal soluble film (FBSF)|"After screening, eligible subjects were individually titrated to an adequate dose of FBSF (titration period) and continued on this dose as required to control their BTP throughout the maintenance period of the study.
~During the dose titration period, subjects were administered with FBSF in a dose escalation manner until a treatment dose was identified (defined as an adequate relief of BTP observed for at least two consecutive episodes). All patient started with a dose of 200 μg and increased by 200 μg in each subsequent episode until an adequate pain relief with tolerable side effects was achieved. Doses above 1200 μg were not allowed."
15897538|NCT03669250|Drug|CVN058|3-way crossover
15897539|NCT03669250|Drug|Placebos|Placebo
15897540|NCT03669237|Procedure|different reconstruction methods|Different reconstruction methods should be performed after sphincter preservation surgery in two groups.The methods include end-to-end anastomosis or end-to-side anastomosis
15897541|NCT03669224|Other|Nano Care Gold|Mixture of Gold and Silver nano particles suspended in 70 % Isopropyl alcohol. This group will be compared with no intervention group.
15897542|NCT03669224|Other|No intervention|No intervention will be applied in this group. It will be the negative comparator. In this group only the standard of care will be applied, which means the steps will be cavity preparation followed by adhesive system then resin composite without any surface pre-treatment
15897543|NCT03669224|Other|Chlorhexidine|2 % chlorhexidine gluconate. This group will be compared with no intervention group.
15897544|NCT03669211|Diagnostic Test|Cardiac stress test|In order to assess the evolution of their cardiorespiratory function, patients will benefit from two cardiac stress test combined with VO2 study, one at inclusion in the study, and the other one 6 months later.
15897545|NCT03669198|Diagnostic Test|NT-Pro BNP|. AHF patients who met inclusion and exclusion criteria were randomly assigned to 2 groups, NT-pro BNP group and control group. In the NT-pro BNP group, serial NT-pro BNP levels at admission and pre-discharge was measured, the latter with the target of decrease ≥ 30% NT-pro BNP level. Randomised patients were followed during treatment up to 90 days post-discharge to assess short-term outcomes and costs.
15897546|NCT03669185|Drug|Pentalong|Pentalong, 2 x daily 1 tablet, intake max. 133 days
15897547|NCT03669185|Drug|Placebos|Placebos, 2 x daily 1 tablet, intake max. 133 days
15897548|NCT03669172|Biological|Donor IL-15 stimulated NK cells infusion|DONOR IL-15-STIMULATED NK CELLS POST TRANSPLANT INFUSION, IN ACUTE LEUKEMIA PATIENTS WITH POOR PROGNOSIS AND HAPLOIDENTICAL UNMANIPULATED TRANSPLANT
15897549|NCT03669146|Device|Glasses|Partial refractive correction in a pair of glasses.
15897550|NCT03669133|Drug|Vitamin E|Vitamin E 800 IU/daily
15897551|NCT03669133|Drug|Placebos|Matching placebo daily
15897552|NCT03669120|Other|Informational Intervention|Receive advice to quit smoking and materials to promote smoking cessation
15897553|NCT03669120|Behavioral|Telephone-Based Intervention|Receive individualized text based messages
15897554|NCT03669107|Drug|Gum|no gum
15897555|NCT03669094|Dietary Supplement|Lactobacillus salivarius V4II-90|7 months intervention study: with a screening period of 12 weeks after which participants GBS+ women will be randomized and start the orally intake of 1 capsule per day of the Lactobacillus salivarius V4II-90 (1*10E9 CFU) probiotic supplement over a 12 weeks period. A visit will then be completed one month after delivery.
15897556|NCT03669094|Dietary Supplement|Placebo|7 months intervention study: with a screening period of 12 weeks after which participants GBS+ women will be randomized and start the orally intake of 1 capsule per day of the placebo supplement over a 12 weeks period. A visit will then be completed one month after delivery.
15897557|NCT03669081|Drug|Ketorolac|Ketorolac was administered intravenously: 30 mg in the operating room, and 15 mg every 6 hours for 7 doses post-operatively.
15897558|NCT03669081|Drug|Pregabalin|Pregabalin was administered orally: 75 mg 30 minutes prior to operation.
15897559|NCT03669081|Drug|Placebo oral capsule|Placebo oral capsule was administered orally 30 minutes prior to operation.
15897560|NCT03669081|Drug|Saline|Saline was administered intravenously: once in the operating room, and every 6 hours for 7 doses post-operatively.
15897561|NCT03669068|Procedure|Gastrointestinal endoscopy|"Two separated groups will be included in the registry:
~Patients with oral anticoagulants-induced gastrointestinal bleeding unrelated to an endoscopic procedure.
~Patients undergoing elective gastrointestinal endoscopy."
15897562|NCT03669055|Other|Magnetic Resonance Imaging|Realization of a MRI before and after the endovascular treatment of the aortic dissection. Use of the 4D phase-contrast sequence during the MRI.
15897563|NCT03669042|Device|PhotoFix|PhotoFix Patch Implantation
15897564|NCT03669029|Drug|Golimumab 50 mg in patients <80 kg and Golimumab 100 mg in patients >80 kg|Clinical response at week 6,14, 30 and 54 will be correlated to serum golimumab levels and anti-golimumab antibody levels.
15897565|NCT03669029|Drug|Golimumab treatment optimization.|Golimumab dosing will be optimized in patients without clinical response at week 6.
15897632|NCT03668548|Dietary Supplement|Leucine|192 mg/kg body mass/day
15897633|NCT03668548|Dietary Supplement|Placebo|A taste and calorie-matched placebo
15897674|NCT03668288|Other|Data record and questionnaires passation|Data record and questionnaires passation (SF36)
15897707|NCT03667963|Other|Cold Rice|Cooked polished rice containing 50g available carbohydrate (approximately 2/3 cup cooked rice) cooled overnight in a refrigerator and consumed cold.
15897566|NCT03669016|Behavioral|Face-to-face group-based mindfulness|"An eight-week course, including 75-90 minutes once-a-week meeting. Participants are supposed to practice mindfulness skills in their spare time 10-30 minutes per day. An eight-week course, including 75-90 minutes once-a-week meeting. Participants are supposed to practice mindfulness skills in their spare time 10-30 minutes per day. This training is based on Jon Kabat-Zinn's course Mindfulness Based Stress Reduction and book Williams & Penman Mindfulness: a practical guide to finding peace in a frantic world and adapted for university students. In addition, a manual written in Cambridge University Mindfulness Skills for Students is utilized."
15897567|NCT03669016|Behavioral|Internet-based mindfulness|An eight-week course, including 60 minutes starting and ending meeting. Participants are practicing mindfulness, doing other tasks (writing, reading, reflecting) on their own. This course is created in University of Jyväskylä, Finland. It is based on mindfulness and Acceptance and Commmitment Therapy.
15897568|NCT03669003|Biological|Gelfoam slurry|Approximately 1-2cc of Gelfoam slurry will be used to lace the needle track.
15897569|NCT03669003|Procedure|CT-guided percutaneous lung biopsy|Biopsy of a lung nodule under CT guidance.
15897570|NCT03668990|Other|IMUs (Xsens, MVN Studio)|It is a full-body human measurement system based on inertial sensors, biomechanical models and sensor fusion algorithms applied in neurological patients for measuring upper limb movements.
15897571|NCT03668977|Dietary Supplement|Fortified balanced protein-energy.|The exact form of this supplement will be selected in Phases one and two but its composition will be in conformance with the recommendations from the expert panel convened by the B&MGF on nutritional supplementation in pregnancy (Expert Consultation, 2016). The calorie content will be approxmately 400 Kcal/day with approximately 14 g of protein.
15897572|NCT03668964|Dietary Supplement|Vitamin B2|One capsule of 75 mg Vitamin B2 once a day for 4 weeks
15897573|NCT03668964|Dietary Supplement|Vitamin C|One capsule of 500 mg Vitamin C once a day for 4 weeks
15897574|NCT03668964|Dietary Supplement|Vitamin B2 + C|One capsule of of 75 mg Vitamin B2 plus 500 mg Vitamin C once a day for 4 weeks
15897575|NCT03668964|Dietary Supplement|Vitamin A|One capsule of 250 µg Vitamin A once a day for 4 weeks
15897576|NCT03668964|Dietary Supplement|Vitamin D3|One capsule of 60 µg Vitamin D3 once a day for 4 weeks
15897577|NCT03668964|Dietary Supplement|Vitamin E|One capsule of 100 mg Vitamin E once a day for 4 weeks
15897578|NCT03668964|Dietary Supplement|Placebo|One capsule of 575 mg microcrystalline cellulose once a day for 4 weeks
15897579|NCT03668951|Drug|Dexmedetomidine buccal|DEX 2 mcg/kg buccal
15897580|NCT03668951|Drug|Dexmedetomidine Intranasal|DEX 3 mcg/kg intranasal
15897581|NCT03668951|Drug|Dexmedetomidine Intranasal|DEX 4 mcg/kg intranasal
15897582|NCT03668938|Other|Occupational Therapy|The intervention in the hospitalization phase is mainly aimed at achieving the objectives related to the self-care area and, secondly, to the objectives in the areas of productivity and leisure time, identified in T0 and to the environmental assessment of the places of life of the patient; more an intervention in the patient's post-discharge home, mainly aimed at achieving the objectives related to social reintegration, the area of productivity and leisure time and, secondly, to possible objectives in the areas of self-care identified in T1.
15897583|NCT03668938|Other|usual care|Usual care consists in rehabilitation treatment delivered by a multidisciplinary team
15897584|NCT03668925|Radiation|magnetic resonance imaging (MRI) of the sacro-iliac region HLA B27 test C-reactive protein (CRP) measurement|magnetic resonance imaging (MRI) of the sacro-iliac region HLA B27 test C-reactive protein (CRP) measurement
15897585|NCT03668912|Behavioral|Guided participation discharge programme|A nurse-led GP discharge intervention (3 structured 30- to 60-minute GP sessions and 1 follow-up phone call)
15897586|NCT03668899|Procedure|irrigation|irrigation of root canals during mechanical preparation for pueposes of cleaning and disinfection
15897587|NCT03668886|Other|multimodal exercise program|warm-up, strengthening exercise, aerobic exercise, cool-down
15897588|NCT03668873|Behavioral|Sleep Parent Training|SPT provides a comprehensive intervention that teaches parents the basic concepts and practical skills to address an array of sleep problems.
15897589|NCT03668873|Behavioral|Sleep Parent Education|SPE is a structured program intended to mimic competent treatment as usual. Thus, SPE is an accepted treatment and serves as an active comparator that controls for time and attention.
15897590|NCT03668860|Drug|Dexamethasone 4 mg/ml|Intramuscular. Total dose: 1.5 mL (6 mg)
15897591|NCT03668860|Drug|Betamethasone 4 mg/ml|Intramuscular. Total dose: 1.5 mL (6 mg)
15897592|NCT03668860|Drug|Celestone Soluspan 6Mg/Ml Suspension for Injection|Intramuscular. Total dose: 1 mL (6 mg)
15897593|NCT03668860|Drug|Dexamethasone Oral Tablet|Oral. Total dose: 12 Tablets (6 mg)
15897594|NCT03668860|Drug|Betamethasone Oral Tablet|Oral. Total dose: 12 Tablets (6 mg)
15897595|NCT03668847|Drug|DM-CHOC-PEN|DM-CHOC-PEN administration by IV infusion
15897596|NCT03668834|Procedure|Dermabrasion with NCES|"The recipient site will be shaved, cleaned with betadine and surgical spirit and anaesthetized with mixture of 2% lignocaine and NS (1:1).
~Dermabrasion will be done using Manekshaw's dermabrader until tiny pinpoint bleeding spots are seen and extended 5mm beyond margins to prevent halo phenomenon.
~The denuded area will be washed with PBS and covered with a PBS moistened gauze piece.
~With 18 G needle attached to tuberculine syringe, few small drops of non cultured epidermal cell suspension will be placed over the denuded surface and spread evenly.
~Dressing is done in 4 layers in order-collagen(Neuskin F), bactigras, cutisoft(sterile gauze) and dynaplast (elastic plaster)."
15897597|NCT03668834|Procedure|Dermaroller with NCES|"The recipient site will be shaved, cleaned with betadine and surgical spirit.
~Microneedling will be done with a device containing 540 microneedles in 8 rows, each 0.25 mm in length. Microneedling will be extended 5 mm beyond margins to prevent halo phenomenon.
~The roller will be passed repeatedly over the skin in a star-shaped way for about 10 minutes
~The noncultured epidermal cell suspension will be carefully transferred to a tuberculin syringe.
~NCES will be applied to the skin surface with a tuberculin syringe with an 18G needle and spread evenly after dermarolling treatment.
~Dressing is done in 4 layers in order-collagen(Neuskin F), bactigras, cutisoft(sterile gauze) and dynaplast (elastic plaster)."
15897671|NCT03668314|Drug|RDN-929 TBD dose|Fed vs fast dose TBD based upon results of previous cohorts
15897672|NCT03668314|Drug|RDN-929|Multiple dose based on results of previous cohorts
15897673|NCT03668314|Drug|Placebo oral capsule|Matching placebo multiple dose
15897598|NCT03668834|Procedure|Liquid nitrogen induced blister with NCES|"The recipient site will be shaved, cleaned with betadine and surgical spirit and anaesthetized with mixture of 2% lignocaine and NS (1:1).
~The site to be grafted is outlined with a surgical marking pen.
~To induce blisters on the achromic areas, freezing with liquid nitrogen spray was performed during 10 to 20 seconds inside round circles previously drawn on the skin.
~The patient is asked to visit 24 hours later.
~The blister fluid is aspirated and NCES taken in tuberculin syringe with 18 G needle is injected into it such that the blister roof is preserved.
~Dressing is done in 4 layers in order-collagen(Neuskin F), bactigras, cutisoft(sterile gauze) and dynaplast (elastic plaster)."
15897599|NCT03668821|Other|Questionnaire|Quality of life and frailty questionnaires
15897600|NCT03668808|Drug|Insulin Degludec|Subjects will use Insulin Degludec (Tresiba) with TRESIBA® FLEXTOUCH® pens as their basal insulin during a 9-10 hour flight, at each destination, and then during a return flight.
15897601|NCT03668808|Drug|Insulin Glargine|Subjects will use Insulin Glargine (Lantus) with LANTUS® SOLOSTAR® INSULIN PEN as their basal insulin during a 9-10 hour flight, at each destination, and then during a return flight.
15897602|NCT03668808|Device|TRESIBA® FLEXTOUCH®|Subjects will use Tresiba FlexTouch pens when using Tresiba as their basal insulin during a 9-10 hour flight, at each destination, and then during a return flight.
15897603|NCT03668808|Device|LANTUS® SOLOSTAR® INSULIN PEN|Subjects will use Lantus SoloStar insulin pens when using Lantus as their basal insulin during a 9-10 hour flight, at each destination, and then during a return flight.
15897604|NCT03668795|Procedure|Bakrey balloon insertion within the uterus and caesarean hysterectomy|Creating an intrauterine tamponade to stop the uterine bleeding by inflating an intrauterine balloon with 600 cc of saline versus undergoing hysterectomy if conservative management failed
15897605|NCT03668782|Procedure|Umbilical cord milking|The babies were held at the level of the placenta, while the umbilical cord was milked or cut and clamped.
15897606|NCT03668769|Other|Internet Mobile Technology|Use Quitting Schedule mobile smartphone app
15897607|NCT03668769|Other|Interview|Ancillary studies
15897608|NCT03668769|Other|Questionnaire Administration|Ancillary studies
15897609|NCT03668769|Behavioral|Smoking Cessation Intervention|Participate in individual smoking cessation program
15897610|NCT03668756|Procedure|Computer-Assisted Navigation TKA|TKAs were performed using the image-free CAS navigation system VectorVision
15897611|NCT03668730|Radiation|Intensity-modulated radiation therapy|Patients undergo low-dose OR standard dose IMRT based on their radiographic response to induction chemotherapy
15897612|NCT03668730|Drug|Paclitaxel liposome|Patients receive Paclitaxel liposome by 135mg/m2 with a total of two cycles.
15897613|NCT03668730|Drug|Cisplatin|Patients receive Cisplatin by 25mg/m2 on day1-day3 with a total of two cycles as induction chemotherapy ; patients receive cisplatin by 100mg/m2 with a total of three cycles as concurrent chemotherapy.
15897614|NCT03668730|Drug|5-Fluorouracil|Patients receive 5-Fluorouracil by 3750mg/m2 civ120h with a total of three cycles.
15897615|NCT03668717|Device|Robotic-arm assisted medical MCK implant|Robotic-arm assisted medical MCK implant system to replace the medial compartment of the knee.
15897616|NCT03668691|Device|Robotic-arm assisted partial knee arthroplasty|Robotic-arm assisted medial unicompartmental knee arthroplasty, lateral unicompartmental knee arthroplasty, bicompartmental knee arthroplasty, patellofemoral knee arthroplasty implants. A robotic arm assisted unicompartmental or bicompartmental knee arthroplasty procedure to replace the medial or lateral and /or patellofemoral compartments of the knee.
15897617|NCT03668678|Other|iGrow Readers Curriculum|As part of the iGrow Readers curriculum, the primary teacher first reads a book as a group with a specific health behavior theme. Then, children participate in nutrition and physical activities that relate and reinforce the lessons learned in the book. Informational newsletters highlighting healthy behaviors from the stories' themes are provided to parents. All implementation strategies are reinforced by research to promote positive choices in young children's health behaviors through the use of literature and language strategies and modeling of others in the children's microsystems.
15897618|NCT03668665|Drug|Ready Medical Post Treatment|"Treatment of half of the wound with the product ready medical post treatment in addition to conventional treatment with moist dressings (Mepilex and Fixomull); on the 1st, 4th and 7th day after surgery, the product is applied to the wound and the dressing is changed"
15897619|NCT03668665|Device|Conventionell Treatment|Treatment of half of the wound with conventional moist dressings (Mepilex and Fixomull); a dressing change only takes place on the 7th day postoperatively
15897620|NCT03668652|Device|Focal HIFU treatment using Focal One (EDAP TMS) or TULSA-PRO (Profound Medical)|"HIFU arm:
~Focal ablation of prostate cancer using HIFU Focal One or TULSA -PRO"
15897621|NCT03668652|Procedure|Radical prostatectomy|"Prostatectomy arm:
~Robot assisted or open retropubic prostatectomy"
15897622|NCT03668639|Drug|Akynzeo|Weekly administration of akynzeo for five weeks.
15897623|NCT03668639|Drug|Dexamethasone|Weekly administration of dexamethasone 12 mg Day 1, 8 mg Day 2-3, and 4 mg Day 4 for five weeks.
15897624|NCT03668626|Other|Family-centered intervention program (FCIP)|This program will include in-hospital intervention, after-discharge intervention and neonatal follow-up. Five sessions of in-hospital intervention will emphasize modulation of the NICU, teaching of child developmental skills, feeding support, massage, interactional activities and parent support and education. The 7-session after-discharge intervention will consist of 4 clinic visits and 3 home visits with specific care in modulation of home environment, teaching of child developmental skills, feeding support, teaching of interactional activities, and parent support and education.
15897625|NCT03668613|Drug|secukinumab low dose|dose depends on the weight group
15897626|NCT03668613|Drug|secukinumab high dose|dose depends on the weight group
15897627|NCT03668600|Drug|Rapastinel|Rapastinel 450 mg (prefilled syringe, weekly or biweekly or up to 4 weeks at the investigator's discretion intravenous IV administration)
15897628|NCT03668587|Other|Troponin Protocol|Feasibility and security of a rapid rule-out and rule-in troponin protocol in the management of NSTEMI in an Emergency Departement.
15897629|NCT03668574|Other|Aerobic exercise|Aerobic exercise that is defined as a form of exercise lasting 15 to 60 minutes continuous and intensity of 60% to 90% of maximal heart rate.
15897630|NCT03668574|Other|Placebo Group|Will be treated with pulsed 5-minute ultrasound and pulsed short-wave diathermy for 25 minutes. The devices will be used with disconnected internal cables to obtain the placebo effect
15897634|NCT03668535|Procedure|Bladder Filling|Group A have a triple-way urethral catheter insertion before establishment of anaesthesia. Evaluation of the drained urine is done (including: amount, character, and simple for culture and sensitivity). Instillation of 200 ml sterile saline is done by 50 ml syringe through the irrigation way. The irrigation way is closed temporarily by artery forceps. After laparotomy the bladder may be deflated by 50 ml or further inflated by 50 ml if needed to allow comfortable dissection.
15897635|NCT03668535|Procedure|Bladder deflation|Group B have Foley's catheter is inserted as usual. The catheter is connected freely to urinary bag.
15897636|NCT03668522|Other|Genetic testing|To determine whether H3F3AK27M exist in spinal glioma
15897637|NCT03668509|Drug|SHR1459|oral adminstration, single dose
15897638|NCT03668496|Drug|SHR-1210|Drug delivery cycle is 3 weeks, and in the experimental group,200 mg shr-1210 was given with Carboplatin and Paclitaxel in the first day of each cycle, with intravenous drip.
15897639|NCT03668496|Drug|The placebo|in the control group,placebo was given with Carboplatin and Paclitaxel in the first day of each cycle, with intravenous drip.
15897640|NCT03668483|Other|Pulmonary rehabilitation|A 6-min walk test, peripheral and respiratory muscle strength measurements, and a dyspnea rating scale Mmrc will be applied to the lung transplantation candidates who are trained in 3-month hospital-based preoperative exercise training in the Pulmonary Rehabilitation unit. The tests will be carried out at the beginning and end of rehabilitation.
15897641|NCT03668470|Drug|Dulaglutide|Dulaglutide 1.5mg : One injection per week during 24 weeks
15897642|NCT03668470|Drug|Placebo|Placebo: one injection per week during 24 weeks
15897643|NCT03668457|Behavioral|Intervention to Patients|"Multifaceted intervention consisting of:
~A collaborative care management intervention, including depression education, medication management and behavioral activation.
~Use of a medication reminder mobile app."
15897644|NCT03668457|Behavioral|Intervention to Psychiatrists|Educational intervention consisting of theoretical and practical sessions to to improve communication and negotiation abilities, and to develop skills to promote patient-centered care and shared decision-making.
15897645|NCT03668457|Other|Control|Other: Usual care Usual care for depressive disorder received in mental health units
15897646|NCT03668444|Behavioral|TXS- Supportive Text Group|TXS participants will receive one treatment supportive text message each day for 30 days.These messages will address three domains 1) Recovery oriented messages, 2) Avoiding relapse and sanctions,and 3) Commitment to family, community and the Drug Treatment Court program. After receiving each text message, participants will receive a second message asking them to reply with a rating of how helpful the original message was. Ratings will use a 5-point Likert scale,ranging from 1-not at all helpful to 5-extremely helpful. Participants will also be asked to describe, via text message, what they liked or did not like about the original message, and suggest a better message for those they did not like.
15897647|NCT03668444|Behavioral|TAU- Treatment As Usual|Participants randomized to the TAU arm of the study will continue to participate in court-ordered treatments as usual with no additional intervention. Participants will receive one motivational text message for the 30-days.
15897648|NCT03668431|Drug|Dabrafenib|"Dabrafenib will be taken twice a day for 28 consecutive days
~."
15897649|NCT03668431|Drug|Trametinib|Trametinib will be taken once a day for 28 consecutive days
15897650|NCT03668431|Drug|PDR001|PDR001 will be administered IV every 28 days
15897651|NCT03668418|Drug|Fluorouracil|The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
15897652|NCT03668418|Drug|Lederfolin|The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
15897653|NCT03668418|Drug|Oxaliplatin|The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
15897654|NCT03668418|Drug|Irinotecan|The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
15897655|NCT03668418|Drug|Docetaxel|The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
15897656|NCT03668418|Drug|Cisplatin|The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
15897657|NCT03668418|Drug|Epirubicin|The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
15897658|NCT03668418|Drug|Gemcitabine|The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
15897659|NCT03668418|Drug|Nab paclitaxel|The enrolled patients after the surgical operation will undergo to the adjuvant chemotherapy treatment
15897660|NCT03668405|Drug|Lu AF20513|Injection
15897661|NCT03668392|Drug|Asparaginase|Measurement of serum Asparaginase activities during therapy, in terms of intensity and duration, as surrogate parameter for asparaginase depletion.
15897662|NCT03668379|Behavioral|Augment w/mHealth|"Non-responders to the first stage treatment of BAT alone may be re-randomized to this augmented intervention to receive text-message support in addition to the BAT intervention."
15897663|NCT03668379|Behavioral|Maintenance|"Responders to the 1st-stage treatment of either 1. BAT or 2. BAT & mHealth will continue in maintenance mode. These participants will not receive any additional interventions during the 2nd-stage treatment."
15897664|NCT03668379|Behavioral|Switch to CBT & mHealth|"Non-responders to the 1st-stage treatment of either 1. BAT or 2. BAT & mHealth may be re-randomized to switch interventions in the form of an intensified dose of Cognitive Behavioral Therapy (CBT). CBT is eight sessions long and covers five modules that can be re-arranged to fit patient needs. Sessions will be scheduled once a week to facilitate more contact with participants. An identical text-messaged tool will be used."
15897665|NCT03668379|Behavioral|Augment w/BAT & mHealth|"Non-responders to the BAT & mHealth intervention may be re-randomized to receive an additional dose of BAT & mHealth in the form of an additional session of BAT."
15897666|NCT03668366|Drug|S-1|The patients will receive IMRT combined with S-1 concurrent chemoradiotherapy. The specific treatment description is included in arm description.
15897667|NCT03668353|Biological|Recombinant SeV-hFGF2/dF Injection|intramuscular injection of investigator drugs
15897668|NCT03668340|Drug|AZD1775|AZD1775 blocks the activity of Wee1, a protein that helps to regulate how cells divide and grow. Certain cancer cells may be more vulnerable to having this process blocked
15897669|NCT03668314|Drug|RDN-929|Single dose from 2 mg to TBD
15897670|NCT03668314|Drug|Placebo oral capsule|Matching placebo Single dose
15897675|NCT03668275|Procedure|(partial) oncological home-hospitalization|Patients assigned to oncological home-hospitalization will receive as many as possible parts of their oncological treatment at their homes. These include the required preparatory actions before treatment administration is possible and/or the treatment administration itself in case of subcutaneous cancer drugs.
15897676|NCT03668262|Drug|Cis-atracurium|Different concentration of cis-atracurium
15897677|NCT03668236|Drug|Isotonic crystalloids|"Types of fluid to be used in both intervention groups:
~IV fluids given for circulatory impairment: Only isotonic crystalloids are to be used as per the Scandinavian guideline for fluid resuscitation
~Fluids given to substitute overt loss: Isotonic crystalloids are to be used. If large amounts of ascites are tapped, then human albumin may be used
~Fluids used for dehydration: Water or isotonic glucose should be used
~Fluids used for electrolyte disturbances: Fluids should be chosen to substitute the specific deficiency, including water in the case of severe hypernatremia
~Blood products are only to be used on specific indications including severe bleeding, severe anaemia and prophylactic in case of severe coagulopathy"
15897678|NCT03668223|Behavioral|Promoting Resilience in Stress Management (PRISM)|Manualized skills training targeting resilience resources: stress-management, goal-setting, cognitive reframing, and meaning-making
15897679|NCT03668210|Procedure|Isokinetic evaluation|Isokinetics is used to measure the peak of strength of quadriceps and hamstrings, in concentric or eccentric, at slow and fast speed to determine a hamstring / quadriceps ratio to highlight a deficit or imbalance.
15897680|NCT03668197|Biological|microbiological analysis|microbiological analysis of the peritoneal fluid
15897681|NCT03668184|Other|preeclampsia|occurrence of pre-eclampsia
15897682|NCT03668171|Procedure|mesenchymal stem cell transplantation or placebo infusion via peripheral vein|0.1-1x10E6 MSCs/kg body weight will be administered via peripheral vein for 3 times at week 0, 4 and 8 mesenchymal stem cell mesenchymal stem cell infusion produced by Cell products of National Engineering Research Center(short for CPNERC), Tianjin, China For control group, placebo infusions will be given to the participants at the same time points
15897683|NCT03668145|Procedure|mesenchymal stem cell transplantation or placebo infusion via peripheral vein|0.1-1x10E6 MSCs/kg body weight will be administered via peripheral vein for 3 times at week 0, 4 and 8 mesenchymal stem cell mesenchymal stem cell infusion produced by Cell products of National Engineering Research Center(short for CPNERC), Tianjin, China For control group, placebo infusions will be given to the participants at the same time points
15897684|NCT03668132|Other|ischemic brain damage|Have or not have the ischemic brain damage and the location of the damage
15897685|NCT03668119|Biological|Nivolumab|Specified dose on specified days
15897686|NCT03668119|Biological|Ipilimumab|Specified dose on specified days
15897687|NCT03668106|Procedure|sperm processing method|different sperm processing method for selcting most proper sperm for ICSI
15897688|NCT03668093|Other|ICCM|comprehensive system for caries management
15897689|NCT03668093|Other|CAMBRA|Caries risk assessment model
15897690|NCT03668067|Device|2WIN photoscreener|conventional infrared off-axis photoscreener
15897691|NCT03668054|Drug|Bevacizumab (Lumiere®)|The first three doses of bevacizumab (Lumiere®) were administered via intravitreal injection on a monthly basis. A safety evaluation was conducted in the first month. Following the first three doses, continuation of the treatment (up to 6 doses) was decided according to response.
15897692|NCT03668041|Drug|Trazodone|Trazodone is approved by the Food and Drug Administration (FDA) for treating major depression in adults but not for PTSD. Although trazodone has not been approved by the FDA to treat insomnia or PTSD, some doctors have tried it for these purposes. The doses in this study will be lower than the doses used to treat depression.
15897693|NCT03668041|Drug|Eszopiclone|Eszopiclone is approved by the FDA for treating insomnia, but it's unknown if eszopiclone can help treat insomnia when it's related to PTSD. Some doctors have tried it for this purpose. The doses in this study will be the same as the doses used to treat insomnia. A small study found it to be helpful for treating patients with PTSD.
15897694|NCT03668041|Drug|Gabapentin|Gabapentin is an FDA approved medication for the treatment of seizures, a type of nerve pain and some forms of chronic pain. Some doctors have prescribed it for insomnia. While the total daily doses in this study are less than the usual total daily dose, the highest dose of gabapentin used in this study will be higher than the typical dose taken at a single time. Doses even higher than this have been taken and observed to be acceptable for treating patients with PTSD.
15897695|NCT03668041|Other|Placebo|The active study medications listed above will be compared with a placebo, which is a pill that looks like a study medication but has no medication in it.
15897696|NCT03668028|Biological|TPX-114|Subjects will be treated with autologous fibroblasts (TPX-114) during arthroscopic surgery.
15897697|NCT03668028|Procedure|Arthroscopic surgery|Subjects undergo conventional arthroscopic surgery for rotator cuff repair.
15897698|NCT03668015|Other|Xylitol then Sorbitol gum|Xylitol gum contains 70% xylitol in addition to gum base, natural flavors, soy lecithin, gum arabic, titanium dioxide, carnuba wax. Sorbitol gum was similar except that xylitol was replaced by 63% sorbitol and 2% maltitol and aspartame was included.
15897699|NCT03668015|Other|Sorbitol then Xylitol gum|Sorbitol gum was similar except that xylitol was replaced by 63% sorbitol and 2% maltitol and aspartame was included. Xylitol gum contains 70% xylitol in addition to gum base, natural flavors, soy lecithin, gum arabic, titanium dioxide, carnuba wax.
15897700|NCT03668002|Procedure|Arteriovenous Fistula (AVF)|If the participant is randomized to the AVF arm of the trial, the surgeon will connect an artery to a vein in the upper extremity, without using artificial material as conduit.
15897701|NCT03668002|Procedure|Arteriovenous Graft (AVG)|If the participant is randomized to the AVG arm of the trial, the surgeon will place a synthetic graft connecting an artery and vein under the skin in an upper extremity.
15897702|NCT03667989|Diagnostic Test|Assessment of cardiac sympathetic innervation by 123I-MIBG|Assessment of cardiac sympathetic innervation by 123I-MIBG CZT SPECT
15897703|NCT03667976|Behavioral|SATHI|see above
15897704|NCT03667963|Other|Glucose|50g glucose dissolved in 250ml water
15897705|NCT03667963|Other|Glucose plus lactulose|50g glucose plus 10g lactulose dissolved in 250ml water
15897706|NCT03667963|Other|Hot Rice|Freshly cooked polished rice containing 50g available carbohydrate (approximately 2/3 cup cooked rice) and consumed hot.
15897708|NCT03667950|Procedure|Hyperspectral Imaging|Photos were taken with the hyperspectral camera of the gastrointestinal anastomosis.
15897711|NCT03667924|Behavioral|PorchLight Project|Senior Companions (or other LSS-MN volunteers providing senior companionship services) who deliver the PorchLight Project will complete online CARES® Dementia Care Specialist training modules, additional trainings delivered by the research team (1. overview of the PorchLight Project, 2. review of the National Consensus Guidelines on Palliative Care, 3. review of the list of guided questions, and 4. review of journaling approach and LTSS resources), and participate in unstructured monthly check-ins (discussions and case review as applicable) with the research team.
15897712|NCT03667911|Other|virtual reality videos|Watch virtual reality videos after routine patient education(both oral and written instructions). Videos give instructions on correct steps of bowel preparation, points for attention, as well as actual images of bowel during colonoscopy in the case of both excellent and unsatisfactory bowel preparation.
15897713|NCT03667898|Procedure|Lumbar plexus block using NTT|An lumbar plexus block is performed using ultrasound guidance with needle tip tracking.
15897714|NCT03667898|Procedure|Lumbar plexus block without NTT|An lumbar plexus block is performed using ultrasound guidance without needle tip tracking.
15897715|NCT03667885|Diagnostic Test|Blood sample|basic blood sample
15897716|NCT03667885|Diagnostic Test|urine sample|basic urine sample
15897717|NCT03667885|Diagnostic Test|Multi planar MRI|T1 (with reduced affinity for fatty tissue) +/- contrast, diffusion weighted sequences and wash in/wash out
15897718|NCT03667872|Procedure|Bilateral implantation of DBS system to Habeluna|Bilateral implantation of MRI compatible and LFP recordable DBS system to Habeluna
15897719|NCT03667859|Diagnostic Test|Vaginal Tactile Imaging|Vaginal elasticity measurements using the Vaginal Tactile Imaging system.
15897720|NCT03667846|Drug|Topiramate|Generic topiramate, FDA-approve for clinical use, will be purchased in 25mg, 50mg, and 100mg strengths, and encapsulated.
15897721|NCT03667846|Other|Placebo|Placebo tablets will be encapsulated in identical capsules.
15897722|NCT03667833|Other|Shoulder brace|Shoulder brace is a designed elastic strap to correct scapula alignment in different characteristics such as tension and direction of force.
15897723|NCT03667820|Drug|Osimertinib|Osimertinib 80mg tablet to be taken once daily.
15897724|NCT03667820|Radiation|SABR|Stereotactic Ablative Radiation (SABR)
15897725|NCT03667807|Device|Repetitive transcranial magnetic stimulation|Non invasive brain stimulation
15897726|NCT03667794|Diagnostic Test|body plethysmography|measurement of conventional lung function parameters
15897727|NCT03667794|Diagnostic Test|impulse oscillometry|measurement of central and peripheral airway resistance
15897728|NCT03667794|Diagnostic Test|multiple breath washout|measurement of ventilation heterogeneity
15897729|NCT03667781|Diagnostic Test|Therapeutic drug monitoring|Blood assay to evaluate for the presence of medications that the patient is prescribed. This is not being used for therapeutic purposes. It has already been validated in prior papers.
15897730|NCT03667768|Procedure|Glass ionomer sealant|
15897731|NCT03667768|Behavioral|Non-sealant (toothbrushing)|
15897732|NCT03667755|Procedure|fast track recovery surgery with whey protein infused carbohydrate loading and early oral feeding|participants will be carbohydrate loaded with whey protein infused carbohydrate drink and started on early oral feeding post-operation
15897733|NCT03667742|Diagnostic Test|analysis of sweat and serum samples for protein markers|collection of blood and sweat samples (with Macroduct Sweat Collecting System) in patients with suspected tuberculosis or proven acute tuberculosis or pulmonary diseases (pneumonia, bronchitis, COPD) and analyzing serum and sweat for protein markers (Early Secretory Antigenic Target (ESAT-6) and Culture Filtrate Protein 10 (CFP-10) and C-reactive protein (CRP) and Amyloid A2 and complement component 1q (C1q)) by mass spectrometry and enzyme-linked immunosorbent assay (ELISA)
15897734|NCT03667729|Behavioral|progressive muscle relaxation|intervention group: The experimental group received muscle relaxation training once a week for 3 consecutive months. The results were measured and followed up after 3 months.
15897735|NCT03667716|Drug|COM701|COM701 monotherapy.
15897736|NCT03667716|Drug|COM701 with Opdivo (Nivolumab).|COM701 in combination with Opdivo (Nivolumab).
15897737|NCT03667703|Drug|Famotidine|Patients will be randomized to either receive a placebo or famotidine (study drug).
15897738|NCT03667703|Drug|Placebo|Patients will be randomized to either receive a placebo or famotidine (study drug).
15897739|NCT03667690|Drug|Rezafungin for Injection|Intravenous antifungal therapy
15897740|NCT03667690|Drug|Caspofungin|Intravenous antifungal therapy
15897741|NCT03667690|Drug|Fluconazole|Oral antifungal therapy
15897742|NCT03667690|Drug|intravenous placebo|Normal saline
15897743|NCT03667690|Drug|oral placebo|Microcrystalline cellulose
15897744|NCT03667677|Drug|Tandospirone + Amlodipine|The first group will receive a 30 mg dose of tandospirone one day( a 10 mg dose of tandospirone each time and three times a day) and a 5 mg dose of amlodipine one day(a 5 mg dose of amlodipine and one time a day).
15897745|NCT03667677|Drug|Tandospirone placebo + Amlodipine|The second group will receive a 30 mg dose of tandospirone placebo one day( a 10 mg dose of tandospirone placebo each time and three times a day) and a 5 mg dose of amlodipine one day(a 5 mg dose of amlodipine and one time a day).
15897746|NCT03667677|Drug|Tandospirone + Amlodipine placebo|The third group will receive a 30 mg dose of tandospirone one day( a 10 mg dose of tandospirone and three times a day) and a 5 mg dose of amlodipine placebo one day(a 5 mg dose of amlodipine placebo and one time a day).
15897747|NCT03667677|Drug|Tandospirone placebo + Amlodipine placebo|The fourth group will receive a 30 mg dose of tandospirone placebo one day( a 10 mg dose of tandospirone placebo each time and three times a day) and a 5 mg dose of amlodipine placebo one day(a 5 mg dose of amlodipine placebo and one time a day).
15897748|NCT03667664|Behavioral|Physical exercises et nutritional counseling in elderly people at risks of loss of autonomy|"Pre-program : eligibility criteria, nutritional status (MNA score, BMI, recent loss of weight), previous history, comorbidities, clinical examination, number of loss in the previous year, Rapid Assessment of Physical Activity score, activities of daily living and Instrumental activities of daily living, Medical Outcome Study Short Form 36 score, physical tests (Hand grip, Short Physical Performance Battery, Knee extension, Neurocom platform physical tests, Dual X-Ray Absorptiometry and Bio-impedance for Body Mass measurement, Muscular echography.
~Implementation of a one year multimodal program based on physical exercises and nutrition counseling as a way of preventing dependence and loss of autonomy in elderly people."
15897749|NCT03667651|Drug|EpiCeram|Parents will be instructed to apply EpiCeram™ to the full skin surface of their child twice per day for six months.
15897750|NCT03667638|Combination Product|Platelet-Rich Plasma|Adding PRP to wound bed during surgical debridement
15897751|NCT03667625|Other|Multidimensional Mobility Exercises|Multidimensional mobility exercises, combined with breathing exercise protocol was established by a committee of specialized physiotherapists and rheumatologist. Land-based and aquatic-based exercises were designed according to environmental features (gravity, buoyancy, viscosity etc).
15897752|NCT03667625|Other|Control group|A conventional home exercise programme was given by a specialized physiotherapist to control group. Patients were checked and encouraged to continue their programs by weekly phone calls for eight weeks
15897753|NCT03667599|Other|home care|This is the interventional arm where patients receive the transplant care in their homes.
15897754|NCT03667586|Behavioral|Group cognitive behavioral therapy|Group sessions based on the principles of Cognitive Behavioral Therapy and adjusted for chronic disease patients
15897755|NCT03667573|Device|tsDCS Dosage (A)|mild electrical stimulation delivered to lumbosacral spinal cord
15897756|NCT03667573|Device|tsDCS Dosage (B)|mild electrical stimulation delivered to lumbosacral spinal cord
15897757|NCT03667573|Other|textured shoe insoles|textured shoe insoles
15897758|NCT03667560|Procedure|Dermacell ADM without basement membrane|Patient will be implanted with Dermacell ADM.
15897759|NCT03667560|Procedure|FlexHD|Patient will be implanted with FlexHD.
15897760|NCT03667547|Drug|Raltegravir|Raltegravir 600 mg tablet
15897761|NCT03667534|Diagnostic Test|Dry blood spot screening|Dry blood spot measurement of biomarker for screening of cholestasis patients
15897762|NCT03667521|Procedure|nerve-sparing laparaoscopic sacrocolpopexy|nerve-sparing laparaoscopic sacrocolpopexy implemented after 2010
15897763|NCT03667508|Procedure|Rapid Maxillary Expanding Device|The expansion screw will be turned two times in the first day, and then daily until the correction is achieved.
15897764|NCT03667508|Procedure|Slow Maxillary Expanding Device|The expansion screw will be activated every five days until correcting the crossbite.
15897765|NCT03667482|Drug|Cabozantinib|Cabozantinib will be initiated at 40 mg PO daily, with subsequent 20 mg or 40 mg doses as tolerated per the study design.
15897766|NCT03667482|Drug|Cetuximab|Cetuximab will be administered at 500 mg/m^2 intravenously every other week on Days 1 and 15 of each cycle, with a window of up to 3 days before the scheduled date. In an effort to prevent a hypersensitivity reaction, it is recommended that all patients pre-medications, hydration, and anti-emetics will be given according to institutional guidelines and/or per treating physician discretion.
15897767|NCT03667469|Procedure|Laparoscopic one anastomosis gastric bypass|Laparoscopic surgical bariatric procedure with creation gastric pouch. A jejunal loop was created about 200 cm from the ligament of Treitz and anastomosed to the gastric pouch.
15897768|NCT03667469|Dietary Supplement|Hypocaloric diet therapy|Hypocaloric diet therapy with energy restriction (-500 kcal/d)
15897769|NCT03667456|Procedure|Self-rehabilitation by digital support|Provision to patients selected by doctors or physiotherapists of an interactive digital tool (tablet + inertial sensor) to support self-rehabilitation home Parkinson's patients.
15897770|NCT03667443|Dietary Supplement|Myo-inositol + folic a. + α-lactalbumin|3 months of treatment
15897771|NCT03667443|Dietary Supplement|Myo-inositol + folic a.|3 months of treatment
15897772|NCT03667430|Dietary Supplement|Porous silica|The particle is rod shaped and approximately 1-3 x 0.4-0.5 micrometers with pore sizes in the range of 70-130 Ångström or 7-13 nanometer.
15897773|NCT03667430|Dietary Supplement|Placebo (microcrystalline cellulose)|All participants starts with five days placebo run in period
15897774|NCT03667417|Other|Questionnaires|standardized data collection and 10-year prospective follow-up
15897775|NCT03667404|Dietary Supplement|Resistant maltodextrin|Resistant maltodextrin powder
15897776|NCT03667404|Dietary Supplement|maltodextrin|maltodextrin powder
15897777|NCT03667378|Behavioral|Expectations Survey (CanCORS)|Study assessments will be conducted at baseline (t0); at 3-6 weeks +/- 1 week from Day 1 of receiving investigational therapy, prior to sharing information on treatment response and before the first planned scan to evaluate extent of disease (t1); and at 8-12 weeks (the end of the 3 month total study time period) (t2).
15897778|NCT03667378|Behavioral|Values Survey (Serious Illness Care Program)|Study assessments will be conducted at baseline (t0); at 3-6 weeks +/- 1 week from Day 1 of receiving investigational therapy, prior to sharing information on treatment response and before the first planned scan to evaluate extent of disease (t1); and at 8-12 weeks (the end of the 3 month total study time period) (t2).
15897779|NCT03667378|Behavioral|Functional Assessment of Cancer Therapy-General (FACT-G)|Study assessments will be conducted at baseline (t0); at 3-6 weeks +/- 1 week from Day 1 of receiving investigational therapy, prior to sharing information on treatment response and before the first planned scan to evaluate extent of disease (t1); and at 8-12 weeks (the end of the 3 month total study time period) (t2).
15897780|NCT03667378|Behavioral|NCCN Distress Thermometer|Study assessments will be conducted at baseline (t0); at 3-6 weeks +/- 1 week from Day 1 of receiving investigational therapy, prior to sharing information on treatment response and before the first planned scan to evaluate extent of disease (t1); and at 8-12 weeks (the end of the 3 month total study time period) (t2).
15897781|NCT03667378|Behavioral|Hospital Anxiety and Depression Scale (HADS)|Study assessments will be conducted at baseline (t0); at 3-6 weeks +/- 1 week from Day 1 of receiving investigational therapy, prior to sharing information on treatment response and before the first planned scan to evaluate extent of disease (t1); and at 8-12 weeks (the end of the 3 month total study time period) (t2).
15897782|NCT03667378|Behavioral|Quality of Communication (QOC)|Study assessments will be conducted at baseline (t0); at 3-6 weeks +/- 1 week from Day 1 of receiving investigational therapy, prior to sharing information on treatment response and before the first planned scan to evaluate extent of disease (t1); and at 8-12 weeks (the end of the 3 month total study time period) (t2).
15897783|NCT03667378|Behavioral|visits with a supportive care clinician|Monthly visits with a supportive care clinician
15897784|NCT03667365|Procedure|aortic valve replacement|aortic valve replacement surgical or transcatheter aortic valve replacement (will be decided by the heart team before randomization)
15897785|NCT03667365|Other|strict clinical surveillance|strict clinical surveillance strategy
15897786|NCT03667352|Procedure|Unilateral Scalp Block|Scalp block is provided by injecting local anaesthetic in the scalp at specific areas to block 6 nerves which are responsible for sensory innervation of the scalp - Supraorbital and supratrochlear nerves, Zygomaticotemporal nerve, Auriculotemporal nerve, Greater and lesser occipital nerves.
15897787|NCT03667352|Procedure|Transversus abdominis plane block|The transverse abdominis plane (TAP) block is a peripheral nerve block designed to anesthetize the nerves supplying the anterior abdominal wall (T6 to L1). It is usually accomplished by a single bolus injection into the transversus abdominis plane through the lumbar triangle of Petit and can be accomplished either by blind landmark based technique or alternatively under ultrasound guidance (as in this study).
15897788|NCT03667352|Drug|Intravenous Fentanyl|Fentanyl is a commonly used opioid drug administered for analgesia in the perioperative period. It may be used as either intermittent bolus administration or continuous infusion or a combination of the two. Usual infusion doses range from 1-2 microgram/kg/hr, which may be titrated based on intraoperative haemodynamics or postoperative patient reported pain scores.
15897789|NCT03667339|Procedure|Direct Anterior Total Hip Arthroplasty|Direct Anterior Total Hip Arthroplasty
15897790|NCT03667326|Drug|Aspirin|Low dose aspirin, 81mg tablets, PO
15897791|NCT03667326|Drug|Placebo oral capsule|Placebo oral capsule, PO
15897792|NCT03667313|Combination Product|sirolimus-eluting balloon (SEB) MagicTouch|Patients with coronary in-stent restenosis treated with sirolimus-eluting balloon
15897793|NCT03667313|Combination Product|paclitaxel-eluting balloon (PEB) Sequent Please|Patients with coronary in-stent restenosis treated with paclitaxel-eluting balloon
15897794|NCT03667300|Drug|Evogliptin|This group will take daily evogliptin 5mg per oral, not linagliptin.
15897795|NCT03667300|Drug|Linagliptin|This group will take daily linagliptin 5mg per oral, not evogliptin
15897796|NCT03667287|Procedure|Repair of parastomal hernia|Surgical repair of symptomatic parastomal hernia.
15897797|NCT03667274|Procedure|cardiac valve surgery|cardiac double valve surgery (aortic and mitral valve)
15897798|NCT03667261|Device|Sealing Socket Abutment|Sealing Socket Abutment (SSA) serves as a mechanical barrier to isolate the grafted area, stabilize the clot and contain the graft material, and seal the socket from foreign contaminants and also minimizing the risk of premature loading of the implant during healing. By preparing an SSA fabricated to follow the transmucosal contours of the natural tooth, the grafted area can be sealed and separated from the growth of soft tissue without the use of a membrane or releasing incisions
15897799|NCT03667261|Device|cover screw|immediate implant placement in mandibular molar area will be covered with conventional cover screw
15897800|NCT03667248|Device|Sorin Perceval ® Sutureless Valve (Sorin Group Italia Srl, 13040 Saluggia, Italy), available in different sizes (S 19-21mm, M 21-23mm, L 23-25mm, XL 25-27mm)|Sizing of the valve by preoperative CT scan of the heart and comparison of this measurement with the standard procedure (Sizing intraoperatively using the measuring devices provided by the product manufacturer)
15897801|NCT03667235|Other|Treatment of human pericardium with glutaraldehyde in OZAKI procedure|10 versus 20 minutes treatment of human pericardium with 0.6% glutaraldehyde in OZAKI procedure
15897802|NCT03667235|Other|Treatment of human aortic valve tissue with glutaraldehyde|10 versus 20 minutes treatment of human aortic valve tissue with 0.6%glutaraldehyde
15897803|NCT03667222|Drug|minocycline topical gel|Once daily administration of BPX-04 minocycline gel for 12 weeks
15897804|NCT03667222|Drug|topical gel vehicle|Once daily administration of BPX-04 gel vehicle for 12 weeks
15897805|NCT03667209|Other|Pain neuroscience education (PNE) and traditional exercise|"PNE will cover the neurophysiology of pain, transition from acute to chronic pain and the nervous system ability to modulate the pain experience.
~Exercise of the neck and scapular regions, including strength, motor control and stretching exercises.
~Initially (first 3 sessions) will be delivered individually and then (last 3 sessions)in small groups (4 participants). A total of 6 sessions will be delivered during 6 weeks. Each session will take around 1 hour."
15897806|NCT03667209|Other|Pain neuroscience education (PNE) and suspension exercise|"PNE will cover the neurophysiology of pain, transition from acute to chronic pain and the nervous system ability to modulate the pain experience.
~Exercise of the neck and scapular regions, including strength, motor control and stretching exercises. delivered in suspension.
~Initially (first 3 sessions) will be delivered individually and then (last 3 sessions)in small groups (4 participants). A total of 6 sessions will be delivered during 6 weeks. Each session will take around 1 hour."
15897807|NCT03667196|Procedure|antegrade and retrograde approach|This study intends to identify and compare the clinical, anatomical and periprocedural factors of the patients who used only the antergrade approach and the patients who needed the retrograde approach among the patients with coronary CTO
15897808|NCT03667183|Other|Pilates|Specific postures in movement according to Pilates guidelines.
15897809|NCT03667170|Biological|KN035|subcutaneous injection
15897810|NCT03667157|Drug|every week IVMP therapy|12 pulses of intravenous methylprednisolone (IVMP) in every week schedule (for the first 6 weeks 0.5g IVMP per week, for the next 6 weeks 0.25g IVMP per week; cumulative dose 4.5g) according to EUGOGO recommendations
15897811|NCT03667157|Drug|very high doses IVMP therapy|3 pulses of intravenous methylprednisolone (IVMP) (1.0g/day for 3 consecutive days; cumulative dose 3.0g) according to EUGOGO recommendations
15897812|NCT03667131|Drug|Enalapril Maleate|Enalapril Maleate 5 mg tablet, every 12 hrs for 90 days.
15897813|NCT03667131|Drug|Placebo|Placebo 5 mg tablet, every 12 hrs for 90 days.
15897814|NCT03667118|Dietary Supplement|Food Supplement|A powder blend of 16 common allergenic proteins ([oat, milk, egg, sesame, wheat] [almond cashew, hazelnut, peanut, pecan, pistachios, soy, walnut] [cod, shrimp, salmon]) combined with 400 IU of Vitamin D3
15897815|NCT03667105|Procedure|CAF|Periodontal surgical technique to treat gingival recessions.
15897816|NCT03667105|Other|MC|Xenogenous graft placed in the surgical site.
15897817|NCT03667105|Other|XDM|Xenogenous dermal collagen graft placed in the surgical site.
15897818|NCT03667092|Biological|non-drug intervention type|8 peripheral blood samples (8x5ml) will be obtained at different times ; before, during and after treatment
15897819|NCT03667079|Other|integrated delivery of deworming and vaccination|integrated delivery of mass drug administrations, one targeting humans (deworming) and one targeting animals (rabies vaccination)
15897820|NCT03667079|Other|Mass deworming only|Delivery of mass deworming to people only
15897821|NCT03667079|Other|Mass vaccination of dogs|Delivery of mass vaccination of dogs only
15897822|NCT03667066|Drug|Clopidogrel|Patients who were on long-term (more than 3 months) of clopidogrel or received a loading dose more than 4 hours prior to elective percutaneous coronary intervention.
15897823|NCT03667053|Drug|dasiglucagon|glucagon analog
15897824|NCT03667053|Drug|placebo|placebo for dasiglucagon
15897825|NCT03667053|Drug|GlucaGen HypoKit|native glucagon
15897826|NCT03667040|Behavioral|JOOL app|Participants will use the JOOL app for 30 days
15897827|NCT03667027|Device|Respiratory support|Mechanical ventilation or extracorporeal life support
15897828|NCT03667014|Drug|Dupilumab|Dupilumab treatment
15897829|NCT03667001|Drug|Lidocaine Hydrochloride|The intervention to be studied will be the additional application of systemic lidocaine 1% dosed 1.5 ml/kg LBM to general anesthesia in bariatric surgery. Patients, randomly assigned to one study group, will be surveyed for 48 hours after completion of surgery, experienced pain, occurrence of PONV, time to first defecation and length of hospitalization will be monitored. Patients, medical practitioner, nurses and investigators will be blinded by utilization of equal appearance and packing of IMPs, which will be fabricated individually for each patient and on request one to two days before surgery by the pharmacy. Each patient will self-evaluate his maximal experienced pain eight-hourly during a sequence of 48 hours after completion of surgery.
15897830|NCT03667001|Drug|Saline Solution|The intervention to be studied will be the additional application of NaCl 0.9% dosed 1.5 ml/kg LBM to general anesthesia in bariatric surgery as a placebo. Patients, randomly assigned to one study group, will be surveyed for 48 hours after completion of surgery, experienced pain, occurrence of PONV, time to first defecation and length of hospitalization will be monitored. Each patient will self-evaluate his maximal experienced pain eight-hourly during a sequence of 48 hours after completion of surgery.
15897831|NCT03666988|Drug|GSK3368715|GSK3368715 will be available with dosing strengths of 25 mg, 100 mg and 250 mg to be administered once daily as an oral capsule.
15897832|NCT03666988|Drug|GSK3368715|GSK3368715 will be available in Immediate release (IR) white film coated tablet with dosing strengths of 50 mg, 100 mg and 250 mg to be administered orally once daily .
15897833|NCT03666975|Device|LIV 30 Hz|LivMD LIV platform
15897834|NCT03666949|Drug|All General anesthesia|"Use of a hypnotic(propofol 2.5mg/kg), morphine(remifentanil1yg/kg) and curare(atracurium0.5mg/kg), with the support of orotracheal intubation and mechanical ventilation"
15897835|NCT03666949|Drug|All Locoregional anesthesia|"Use of a local anesthetic( xylocaine 1%) for the realization of scalp nerve block"
15897836|NCT03666936|Other|Social-health care intervention|Cancer survivors enrolled in the study could receive support from the Occupational Therapist and/or from the social care professionist to overcome the difficulties encounter at work or to facilitate work reintegration.
15897837|NCT03666923|Drug|THR-687 dose level 1|single intravitreal injection of THR-687 dose level 1
15897838|NCT03666923|Drug|THR-687 dose level 2|single intravitreal injection of THR-687 dose level 2
15897839|NCT03666923|Drug|THR-687 dose level 3|single intravitreal injection of THR-687 dose level 3
15897840|NCT03666910|Diagnostic Test|Audiometer|detection of hearing problems
15897841|NCT03666897|Other|DTI Images and Plasma Biomarkers|Additional Images added from standard of care MRI, Bio-markers identified
15897842|NCT03666884|Drug|COE 2*1 (Restasis) + PFAT Refresh Single dose) 8*1|clinical improvement in oxford scale, ocular surface disease index, schirmers test, tear break up time, fluorescein staining of eye
15897843|NCT03666884|Biological|AS 50% eye drops 8*1|clinical improvement in oxford scale, ocular surface disease index, schirmers test, tear break up time, fluorescein staining of eye
15897844|NCT03666871|Biological|SB-728-T|Autologous CD4+ T cells with ex vivo modification of the CCR5 gene by zinc finger nucleases
15897845|NCT03666871|Biological|Expanded unmodified autologous CD4+ T cells|Autologous CD4+ T cells without ex vivo modification of the CCR5 gene by zinc finger nucleases
15897846|NCT03666845|Procedure|Sciatic nerve block|Sciatic nerve block will be performed using ropivacaine (2.5mg/kg) under ultrasound-guidance with nerve stimulator.
15897847|NCT03666832|Drug|TEW-7197|"TEW-7197 1cycle 14days
~-intake 5days, rest 2days"
15897848|NCT03666819|Device|Carbon Dioxide Fractional Laser|Undergo CO2RE laser therapy
15897849|NCT03666819|Other|Questionnaire Administration|Ancillary studies
15897850|NCT03666806|Biological|Influenza vaccine|The randomized FLUVACS trial demonstrated the benefits of influenza vaccination in the prevention of cardiovascular death. In the VIPS study the risk for acute ischaemic stroke (AIS) in children increased by 6-fold compared to the baseline population. It was postulated that infections and in particular upper respiratory tract infections acts as a stroke trigger in a child who is otherwise predisposed to stroke and why it would occur at a particular point in that child's life. It should be noted that major infections such as meningitis have been causes of stroke while this study has shown that minir infections can also act as a trigger for stroke in adults
15897851|NCT03666793|Other|global care|Medication Reconciliation at admission, Multidisciplinary medication review, Medication Reconciliation at discharge
15897852|NCT03666780|Device|LAmbre occluder|All patients are implanted with a LAmbre occluder device
15897853|NCT03666767|Other|Comparisons will be made between LMICs and HICs|Countries will be defined as low, middle or high-income using the World Bank classification.
15897854|NCT03666754|Procedure|Standard therapy arm|Multilayer elastic compression bandaging/ stockings with the deferred treatment of superficial reflux (usually once the ulcer has healed)
15897855|NCT03666754|Procedure|Early endovenous glue embolization arm|Early endovenous glue embolization of superficial venous reflux within 2 weeks in addition to standard compression therapy
15897856|NCT03666741|Device|AVR with or without CABG|Surgical aortic valve implantation with INSPIRIS RESILIA Aortic Valve™
15897857|NCT03666728|Drug|SHR-1210|SHR-1210 was administered 200 mg iv every 3 weeks
15897858|NCT03666728|Drug|BP102|BP102 was administered 15 mg/kg iv every 3 weeks
15897859|NCT03666715|Drug|Oral Antipsychotics (OAPs)|No study treatment will be administered as a part of this study. Participants will receive OAPs (such as olanzapine, risperidone, paliperidone, aripiprazole or quetiapine) as per their usual clinical practice.
15897860|NCT03666715|Drug|Paliperidone Palmitate 1-Month Formulation (PP1M)|No study treatment will be administered as a part of this study. Participants will receive PP1M as per their usual clinical practice.
15897861|NCT03666702|Other|Upper limb physiotherapy programme|Web-based physio programme
15897862|NCT03666702|Other|Usual care|Usual physiotherapy care
15897863|NCT03666689|Procedure|surgical technique|surgical reconstruction
15897864|NCT03666676|Other|Signal processing to improve intelligibility|Signal processing will be used to manipulate frequency and amplitude fluctuations in complex sounds.
15897865|NCT03666663|Drug|Lidocaine|Nasal application using the Sphenocath device- cleared by FDA
15897866|NCT03666663|Drug|Bupivacaine|Nasal application using the Sphenocath device- cleared by FDA
15897867|NCT03666663|Drug|Ropivacaine|Nasal application using the Sphenocath device- cleared by FDA
15897868|NCT03666663|Drug|Placebo|Placebo Saline using the Sphenocath device- cleared by FDA
15897869|NCT03666650|Drug|Edoxaban 60 MG|Viscoelastic analysis and standard laboratory tests after edoxaban ingestion
15897870|NCT03666637|Procedure|dynamic hip screw (DHS) and cannulated screw (CS)|A preformed case report form was used to collect the data which included the demographic profile of the patients (age, gender), comorbidities, smoking history, mode of injury (high or low energy), presence of multiple trauma, garden classification, side of injury, time to fixation (in hours), type of reduction, type of implant used, RUSH score (healing), start of weight bearing, development of AVN, and final outcome (whether varus, valgus, displaced or healed).
15897871|NCT03666624|Behavioral|Personalized care network|The Personalized care network intervention includes exercise training for participant with dementia and behavioral management training for addressing challenges.
15897872|NCT03666598|Device|Tourniquet|In the patients randomized to the use of tourniquet, the tourniquet time starts before skin incision and terminates when the wound closure starts. The cuff pressure is set at 300mmHg.
15897873|NCT03666585|Other|mobile application actuated rehabilitation exercise guidance|Mobile applications (also known as mobile apps) are software programs developed for mobile devices such as smartphones and tablets, to teach full function following injury and involves restoring strength, flexibility, endurance, and power.
15897874|NCT03666585|Other|routine rehabilitation exercise guidance|the teach to practice full function following injury and involves restoring strength, flexibility, endurance, and power. It is achieved through various exercises and drills
15897875|NCT03666572|Other|Bifidobacterium infantis|Bifidobacterium longum subsp. infantis (EVC001)
15897876|NCT03666572|Other|Bifidobacterium infantis with prebiotic Lacto-N-neotetraose [LNnT]|Bifidobacterium infantis with prebiotic Lacto-N-neotetraose [LNnT]
15897877|NCT03666572|Other|Placebo (Lactose)|Placebo (Lactose)
15897878|NCT03666559|Drug|Azacitidine|Chemotherapy
15897879|NCT03666546|Drug|Lactulose crystals 20 g|White or almost white crystalline powder. The product will be provided in sachets to be dissolved in 250 mL water.
15897880|NCT03666546|Drug|Lactulose crystals 30 g|White or almost white crystalline powder. The products will be provided in sachets to be dissolved in 250 mL water.
15897881|NCT03666546|Drug|Lactulose liquid 20 g|Clear, viscous liquid, colourless or pale brownish-yellow liquid syrup (solution). The products will be provided in sachets to be dissolved in 250 mL water.
15897882|NCT03666546|Drug|Lactulose liquid 30 g|Clear, viscous liquid, colourless or pale brownish-yellow liquid syrup (solution). The products will be provided in sachets to be dissolved in 250 mL water.
15897883|NCT03666546|Drug|Glucose|White crystalline powder. To standardise for 30 g glucose, 33 g glucose monohydrate will be used. The products will be provided in sachets to be dissolved in 250 mL water.
15897884|NCT03666546|Drug|Still water|250 mL still water will be used. Water from the same source will be also used to dissolve investigational and control products
15897885|NCT03666533|Other|Active transcranial Direct Current Stimulation|Active tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy
15897886|NCT03666533|Other|Sham transcranial Direct Current Stimulation|Sham tDCS is combined with gait therapy. Gait therapy includes gait task practice in Virtual Reality setting and overground gait therapy
15897887|NCT03666520|Other|Clinical Decision Support prompted to the clinician to convert drug.|This study is designed to further research the conversion of Intravenous medications to oral medications in patients in an inpatient setting whenever it is appropriate and safe. We have chosen eight medications to research in this study. These medications were chosen because large difference in cost between an intravenous (IV) dose of this medication versus an oral (PO) dose of this medication exist. This study aims to further evaluate the appropriateness and safety of converting IV medications to PO medications for hospitalized patients through a pilot clinical trial.
15897888|NCT03666507|Procedure|Intraoperative Monitoring during resection of brain tumor|Intraoperative Monitoring during resection of brain tumor
15897889|NCT03666494|Drug|Ketamine Hydrochloride|As part of anesthetic induction, the addition of ketamine hydrochloride 0.5mg/kg.
15897890|NCT03666494|Drug|Propofol|As part of the patient's anesthetic induction, they will receive propofol.
15897891|NCT03666494|Drug|Fentanyl|As part of the patient's anesthetic induction, they will receive fentanyl.
15897892|NCT03666481|Behavioral|Motivational Physical Activity Intervention (MPAI)|"MPAI was carried out during 6 consecutive months. The sessions were directed by sport sciences professionals, who were trained in the application of motivational strategies based on self-determination theory.
~The frequency of training, as well as the duration of the sessions, was increasing throughout the 6 months. The contents of the sessions could be directed in two ways: sessions with activities to develop cardiorespiratory fitness and muscular strength, and playful sessions to enhance psychosocial aspects. Nevertheless, motivational strategies were implemented in both types of sessions."
15897893|NCT03666468|Other|PlayMed|A highly immersive role-playing computer game focused on Paediatric Asthma and Seizure management
15897894|NCT03666468|Other|Online Package|Online package (OP) of NSW Health Guidelines focused on Paediatric Asthma and Seizure management
15897895|NCT03666468|Other|Paper Guidelines|Paper NSW Health Guideline focused on Paediatric Asthma and Seizure management
15897896|NCT03666455|Behavioral|Acceptance and Commitment Therapy|Acceptance and commitment therapy (ACT) is a type of psychotherapy, or cognitive behavioral therapy, that aims to help patients focus on the present, accept their situation, and find positive coping skills.
15897897|NCT03666442|Drug|XELOX|Xelox chemotherapy,that oxaliplatin 130mg/m2 d1,capecitabine 1000mg/m2 twice daily d1-14,every 3 weeks
15918497|NCT03509012|Drug|Cisplatin (dose level 3)|IV
15897898|NCT03666429|Device|Bulb suction|Parents will use the bulb suction on their child in the emergency room then complete a 7 point likert survey.
15897899|NCT03666429|Device|NoseFrida|Parents will use the NoseFrida in the emergency department and complete a 7 point likert survey.
15897900|NCT03666416|Behavioral|Sprint Interval Training|Participants will attend two experimental appointments, during which they will complete two identical executive functioning tasks (i.e., sustained attention, working memory). During one appointment, participants will receive the sprint interval training manipulation prior to completing the tasks.
15897901|NCT03666403|Procedure|NIV rate: 0/min|A basic PhO2 flow was routinely provided. A small pharyngeal catheter with warmed, humidified and fixed pure oxygen flow was inserted via one nostril to ensured catheter tip positioning in the oropharynx. The NIV was performed in the following steps. Firmly closed the mouth, then intermittently applied a) assisted inspiration by nose-closure accompanied with cricoid depression; and b) assisted expiration by the release of above nose and cricoid maneuver but with simultaneous abdomen-compression. The above assisted ventilation cycle was maintained at a rate of 0-20 cycles per minute. The scopist executed both the FB and the nose-closure and release, whereas an assistant delivered the abdomen compression.
15897902|NCT03666403|Procedure|NIV rate: 10-20/min|A basic PhO2 flow was routinely provided. A small pharyngeal catheter with warmed, humidified and fixed pure oxygen flow was inserted via one nostril to ensured catheter tip positioning in the oropharynx. The NIV was performed in the following steps. Firmly closed the mouth, then intermittently applied a) assisted inspiration by nose-closure accompanied with cricoid depression; and b) assisted expiration by the release of above nose and cricoid maneuver but with simultaneous abdomen-compression. The above assisted ventilation cycle was maintained at a rate of 0-20 cycles per minute. The scopist executed both the FB and the nose-closure and release, whereas an assistant delivered the abdomen compression.
15897903|NCT03666403|Procedure|NIV rate: 5-10/min|A basic PhO2 flow was routinely provided. A small pharyngeal catheter with warmed, humidified and fixed pure oxygen flow was inserted via one nostril to ensured catheter tip positioning in the oropharynx. The NIV was performed in the following steps. Firmly closed the mouth, then intermittently applied a) assisted inspiration by nose-closure accompanied with cricoid depression; and b) assisted expiration by the release of above nose and cricoid maneuver but with simultaneous abdomen-compression. The above assisted ventilation cycle was maintained at a rate of 0-20 cycles per minute. The scopist executed both the FB and the nose-closure and release, whereas an assistant delivered the abdomen compression.
15897904|NCT03666390|Drug|Ketamine|We will elucidate the exact efficacy of a low dose of ketamine infusion for the rapid anti-depression and anti-suicidal ideations.
15897905|NCT03666390|Drug|Midazolam|We will elucidate the exact efficacy of a low dose of ketamine infusion for the rapid anti-depression and anti-suicidal ideations.
15897906|NCT03666377|Other|Gum chewing|1 piece of sugarless gum to be chewed three times daily for 1 hour each.
15897907|NCT03666364|Other|Sperm preparation for ICSI|A new protocol for sperm preparation for ICSI cycles with teratozoospermia in over 35 years old women
15897908|NCT03666351|Drug|Amlodipine 5mg|Amlodipine 5 mg
15897909|NCT03666351|Drug|Losartan|Losartan Potassium 50 mg
15897910|NCT03666351|Drug|Losartan and Amlodipine|Amlodipine 5 mg/Losartan Potassium 50 mg, Amlodipine 5 mg/Losartan Potassium 100 mg
15897911|NCT03666351|Drug|Amlodipine/Losartan/Chlorthalidone|Amlodipine 5 mg/Losartan Potassium 100 mg/Chlorthalidone 12.5 mg
15897912|NCT03666351|Drug|current treatment|treatment is done by maintaining the current treatment
15897913|NCT03666338|Other|Early, goal-directed mobilization|Early, goal directed mobilization using (1) the SOMS algorithm and (2) facilitator
15897914|NCT03666325|Drug|Pembrolizumab|Pembrolizumab at 200 mg every 3 weeks for 9 weeks.
15897915|NCT03666325|Drug|Cetuximab|In case of first progression or no response cetuximab will be added at a weekly dose of 250 mg.
15897916|NCT03666299|Drug|Lidocaine|Infusion of 2% lidocaine hydrochloride at 4 mL/h, started after tracheal intubation and discontinued until 24 h after surgery.
15897917|NCT03666299|Drug|Control|Infusion of normal saline at 4 mL/h, started after tracheal intubation and discontinued until 24 h after surgery.
15897918|NCT03666273|Drug|Bapotulimab (BAY1905254)|Intravenous administration of escalating doses of Bapotulimab
15897919|NCT03666273|Drug|Bapotulimab (BAY1905254) + Pembrolizumab|Intravenous administration of Bapotulimab of fixed dose (expansion), and of a fixed dose of pembrolizumab
15897920|NCT03666260|Procedure|Quadratus Lumborum Block|Quadratus Lumborum Block with echography
15897921|NCT03666260|Procedure|femoral block|femoral block with echography
15897922|NCT03666247|Behavioral|HealthMindr Application|From baseline to 3-month post-test, participants in the intervention arm are granted access and instructed to interact regularly with the HealthMindr messaging platform. The HealthMindr messaging platform delivers messages relevant to both general audiences of sexually-active MSM, as well as messages relevant only to specific subgroups of HIV-positive men, and currently higher and lower risk HIV-negative men. Answers provided during the assessments determine which subset of messages are delivered to app users, with information such as HIV status, changes in self-reported risk behaviors, or other factors that influence the relevance of any given message. The HealthMindr application also offers free condoms, lube, and a HIV and STI testing kits.
15897923|NCT03666247|Behavioral|Waitlist|Participants assigned to the waitlist-control arm will be given a welcome sheet orienting them to the study. The message they view will include the same resources links provided to the intervention arm. The information will cover the importance of testing, links to an online mapping tool about the HIV epidemic in the United States (AIDSVu) and resources to locate HIV testing services and prevention information in their area. No information recommending frequency of testing will be given in the welcome greeting.
15897924|NCT03666221|Drug|Nimotuzumab|Drug: Nimotuzumab Radiation: Intensity Modulated Radiation Therapy
15897958|NCT03665805|Other|neuromuscular transmission monitoring|The acceleromyographic responses of the adductor pollicis muscle as percent of the train-of-four (TOF%) on stimulation of the ulnar nerve by means of the TOFscan neuromuscular transmission monitor (iDMed, Marseille, France).
15897959|NCT03665792|Device|nociception index qNOX|non-invasive, real time, monitoring for nociception stimulation
15897960|NCT03665779|Drug|isosorbide mononitrate|70 pregnant females, induction of labor will be done by Intra vaginal isosorbide mono nitrate (Effox 40 mg MINAPHARM) repeated every 4 hours maximum 4 times
15918498|NCT03509012|Drug|Carboplatin (dose level 1)|IV
15897925|NCT03666208|Device|Sirolimus Coated Balloon|"Sirolimus has been used in organ transplantation as well as coronary stent due to its antiproliferative properties. It has been proven to has better outcome in animal studies compared to paclitaxel, which is about 22% in the sirolimus group versus 75% re-stenosis rate in paclitaxel group.
~Sirolimus is coated on the surface of the angioplasty balloon and is transferred to the vessel wall when balloon is inflated and in contact with the vessel wall.
~The following table compare sirolimus to paclitaxel. In which sirolimus works by cytostatic mechanism with a ten thousand fold of safety margin. And sirolimus's anti-restenosis effect is optimal with the benefit of lower level of competition and lesser tissue absorption and elution."
15897926|NCT03666195|Combination Product|Titanium Dioxide Nanoparticles|incorporating titanium dioxide nanoparticles to PMMA, significantly decreases porosities in the denture resin, rendering titanium dioxide nanoparticles a suitable additive to denture base materials, as it also exhibits anti-microbial effects
15897927|NCT03666182|Other|No Intervention|No Intervention
15897928|NCT03666169|Other|Survey|Survey
15897929|NCT03666156|Other|No intervention|No Intervention
15897930|NCT03666143|Drug|Sitravatinib|Sitravatinib 120 mg orally once daily in combination with tislelizumab 200 mg IV once every 3 weeks
15897931|NCT03666130|Procedure|endoscopic septoplasty|endoscopic septoplasty is the use of nasal endoscopy in the septoplasty surgery for treatment of deviated nasal septum . we aim to compare the outcome of using this method versus conventional septoplasty
15897932|NCT03666078|Procedure|cesarean delivery|women delivered by cesarean section
15897933|NCT03666065|Drug|Aspart insulin|Standard insulin
15897934|NCT03666039|Behavioral|Trainings app|Sensorimotor trainings app for at home Training (tablet-based)
15897935|NCT03666026|Behavioral|1 MyChart R/R|Up to 1 flu vaccine reminder recall notice sent via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system.
15897936|NCT03666026|Behavioral|2 MyChart R/R|Up to 2 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system.
15897937|NCT03666026|Behavioral|3 MyChart R/R|Up to 3 flu vaccine reminder recall notices sent every 3-4 weeks via MyChart to patients who are due for the flu vaccine, per the EMR records of the health system.
15897938|NCT03666000|Genetic|PBCAR0191|Single dose of Allogeneic Anti-CD19 CAR T cells will be infused
15897939|NCT03666000|Drug|Fludarabine|Fludarabine is used for lymphodepletion.
15897940|NCT03666000|Drug|Cyclophosphamide|Cyclophosphamide is used for lymphodepletion.
15897941|NCT03665987|Behavioral|consultation in preoperative assessment clinic|The treatment group will be seen in the preoperative clinic before hospitalization, while the control group will get anesthetic consultation after hospitalization without clinic service. No additional interventions will be given during and after surgery.
15897942|NCT03665948|Other|Dietary Intervention - Ketogenic Diet (KD)|The experimental procedure for each randomly assigned participant included a 4-week of KD diet.
15897943|NCT03665948|Other|Dietary Intervention - Low-Glycemic Index Diet (CHO-LGI)|The experimental procedure for each randomly assigned participant included a 4-week of CHO-LGI diet.
15897944|NCT03665922|Dietary Supplement|BroccoMax®|Nutraceutical neoadjuvant
15897945|NCT03665922|Other|Placebo|control
15897946|NCT03665909|Other|Remote activity monitoring system|The home-based sensor technology of eNeighbor relies on multiple, non-invasive and safe remote monitors (up to 6 sensors) that can alert family caregivers and/or health professionals to potentially negative situations that lead to adverse outcomes (e.g., wandering, falls, incomplete activity of daily living tasks). The technology platform of eNeighbor relies on wireless infrastructure that allows for remote monitoring via alerts that are communicated to the family caregiver's or nurse care manager's personal computers or handheld devices. The Alerts that are generated from the sensors detected abnormal motion or activity are sent to the family caregiver as well as a nurse care manager that monitors the real-time information generated by the eNeighbor sensors.
15897947|NCT03665896|Device|intubation with VivaSight double-lumen tube|
15897948|NCT03665896|Device|intubation with standard double-lumen tube|
15897949|NCT03665896|Procedure|fiberoptic bronchoscopy|
15897950|NCT03665883|Procedure|Monopolar energy|Monopolar energy in TEP for inguinal hernia
15897951|NCT03665883|Procedure|Blunt dissection|Blunt dissection in TEP for inguinal hernia
15897952|NCT03665870|Behavioral|Hypoglycemia Education|Two in-person visits to the home of the participant and 4 phone calls will be conducted to provided education on prevention of hypoglycemia.
15897953|NCT03665857|Behavioral|a multicomponent intervention|"School-level policies Students will not be allowed to drink sugar-sweetened beverage or eat unhealthy snacks in schools and drinking water will be advocated.
~Monitoring of students' weight and height Students will be monitored their weight and height monthly.
~Promotion of physical activity Students will be required to perform at least 60 minutes of moderate to vigorous physical activity each day in school and increase their physical activity outside school (reaching 30 minutes per weekday and one hour per weekend day).
~Health education activities Health education activities will be provided for students (10 sessions, 40 minutes per session, 2-3 weeks once), parents and school teachers.
~The mobile application The mobile application will disseminate health education knowledge among students, parents and teachers, monitor and provide feedback of students' BMI status and diet and physical activity behaviors."
15897954|NCT03665844|Device|SmartSleep Boost On|"SmartSleep device can be configured to two different settings. SmartSleep Boost On setting provides soft audio tones during the night.
~It's a non-invasive portable light weight device designed to stimulate deep slow wave sleep (SWS)."
15897955|NCT03665844|Device|SmartSleep Boost Off|SmartSleep device can be configured to two different settings. SmartSleep Boost Off provides no audio tones.
15897956|NCT03665831|Device|Brainsway H1-Coil Deep TMS System|Deep Transcranial Magnetic Stimulation (dTMS) is a new form of TMS which allows direct stimulation of deeper neuronal pathways than the standard TMS. The H-coil is a novel dTMS coil designed to allow deeper brain stimulation without a significant increase of electric fields induced in superficial cortical regions. dTMS will be administered daily for 4 consecutive weeks.
15897957|NCT03665818|Device|oral appliance treatment|mandibular advancement device to enlarge pharyngeal airway space to get rid of apnea and hypopnea events
15898022|NCT03665259|Procedure|Lower oxygen group|Pre-oxygenation with 60% oxygen during induction of anesthesia
15897961|NCT03665779|Drug|Placebo|70 pregnant females, induction will be done by placebo (pyridoxine) administered in the posterior vaginal fornix.repeated every 4 hours maximum 4 times
15897962|NCT03665766|Drug|Cycloserine,Tacrolimus|
15897963|NCT03665753|Drug|Ketorolac|Subject will receive 10, 20, and 30mg of Ketorolac.
15897964|NCT03665740|Drug|Resveratrol|resveratrol is an OTC supplement
15897965|NCT03665727|Behavioral|Mindfulness|The 15 minute mindfulness session is a scripted mindfulness exercise that incorporates mindfulness principles of intentionally paying attention to present-moment experience in a non-judgmental fashion.
15897966|NCT03665727|Behavioral|Suggestion|The 15 minute suggestion session is a scripted suggestion exercise that incorporates imagery and suggestions for changes in cognition, emotion, and body sensations.
15897967|NCT03665727|Behavioral|Psychoeducation|The 15 minute psychoeducation session is a supportive session in which behavioral coping strategies for pain management are discussed.
15897968|NCT03665714|Other|Impact Oral|Impact Oral belongs to Food for Special Medical Purpose (FSMP) according to China registration regulation, including Omega-3 fatty acids, Arginine and Nucleotides immunonutrition.
15897969|NCT03665714|Other|Enteral Nutrition Emulsion(TPF-T)|TPF-T
15897970|NCT03665701|Procedure|Blood Sampling|Blood samples used within in vitro experiments to investigate the activation potency of Prostaglandin D2 metabolites to the DP2 receptor in comparison to Prostaglandin D2.
15897973|NCT03665675|Biological|Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes|Given intravenously
15897974|NCT03665662|Other|Music|Intra-procedure music through headphones
15897975|NCT03665649|Procedure|CD133+ cells isolation|Hematopoietic precursors from human donors will be mobilized by administering Colony Stimulating Factors (G-CSF) for 5 days (according to the clinical standard administration) and subsequently CD133+ cells will be isolated and transferred in a murine model.
15897976|NCT03665636|Drug|Triheptanoin|This is an open-label study. The UX007 (triheptanoin) starting dose will be 0.25 - 0.5 g/kg and titrated to a maximum of 2.5g/kg depending the on the subject's tolerance. The dose may be reduced if not tolerated. The compound will be administered 3-4 times per day, either at the end of a meal or with a snack. It should be given at least 2 hours apart from any cornstarch dose to allow each to act independent of one another, and to prevent the risk of increased gastrointestinal side effects. The doses may be held during episodes of gastroenteritis or diarrhea.
15897977|NCT03665610|Drug|ozanimod|ozanimod
15897978|NCT03665597|Biological|Pembrolizumab Dose C|SC injection
15897979|NCT03665597|Biological|Pembrolizumab Dose A|SC injection
15897980|NCT03665597|Biological|Pembrolizumab Dose B|IV infusion
15897981|NCT03665597|Biological|Pembrolizumab Dose D|IV infusion once every 6 weeks
15897982|NCT03665584|Device|FxCO2 Laser|The FxCO2 laser allows a microablative effect in soft tissue.
15897983|NCT03665584|Device|Sham Laser|The Sham laser will be used on the participants who receive the sham treatment.
15897984|NCT03665571|Diagnostic Test|Receptor specific activation method|NK cell was incubated with P815-ULBP1+CD48 cells that trigger NK cell synergy via NKG2D and 2B4
15897985|NCT03665558|Device|Temporary DDD pacing|Measurements will be performed in patients otherwise undergoing invasive catheterization procedure. Baseline ventricular and aortic hemodynamic parameters (continuous pressure recordings) will be recorded. Thereafter, DDD pacing with stepwise changing of the AV delay will be performed. During each pacing steps left ventricular and aortic pressures at different aortic levels will be continuously recorded. From these hemodynamic data, left ventricular and aortic dP/dt values will be calculated off line.
15897986|NCT03665545|Drug|IMA950/Poly-ICLC|IMA950 mixed with Poly-ICLC administered subcutaneously
15897987|NCT03665545|Drug|IMA950/Poly-ICLC and pembrolizumab|IMA950 mixed with Poly-ICLC administered subcutaneously in combination with pembrolizumab
15897988|NCT03665532|Behavioral|Youth Engagement in Services|Brief phone coaching to enhance engagement, retention, and sustain adherence to HIV and substance use services for younger people living with HIV.
15897989|NCT03665519|Dietary Supplement|Sublimated mare milk|The dietary supplement mare milk product, which is obtained from fresh mare milk (few hours) through sublimation process.
15897990|NCT03665519|Drug|Ursodeoxycholic Acid|Ursodeoxycholic acid treatment will be given for 3 months.
15897991|NCT03665506|Drug|Trifluridin/Tipiracil|QoL assessment
15897992|NCT03665493|Drug|PD patients H&Y=1.5-2 Medications ON|Parkinson's patients will be allowed to the first-morning dose of levodopa medicament (levodopa, dopamine agonists, anticholinergic drugs, or a combination of levodopa and an anticholinergic drug) which normally allowed the patient to attain the best control of symptoms one hour before being tested (19). Patients will perform both the stop-signal task and the go-only task. Experimental conditions will be counterbalanced across patients.
15897993|NCT03665493|Drug|PD patients H&Y=1.5-2 Medications OFF|Parkinson's patients will not take medications overnight prior to the study (20). Patients will perform both the stop-signal task and the go-only task. Experimental conditions will be counterbalanced across patients. This intervention will be given on a different day with respect to the Medication ON intervention. The order of intervention will be counterbalanced across subjects
15897994|NCT03665493|Behavioral|Healthy age-matched controls|Healthy controls will perform the stop signal task and the go-only task in the same day. The order of administration will be counterbalanced.
15898118|NCT03664310|Other|FSET Anxiety and Sleep Treatment|Computerized anxiety and insomnia intervention.
15898119|NCT03664310|Other|Control|Physical health control
15897995|NCT03665493|Drug|PD patients H&Y=3 Medications OFF|Parkinson's patients will not take medications overnight prior to the study (20). Patients will perform both the stop-signal task and the go-only task. Experimental conditions will be counterbalanced across patients. This intervention will be given on a different day with respect to the Medication ON intervention. The order of intervention will be counterbalanced across subjects
15897996|NCT03665493|Drug|PD patients H&Y=3 Medications ON|Parkinson's patients will be allowed to the first-morning dose of levodopa medicament (levodopa, dopamine agonists, anticholinergic drugs, or a combination of levodopa and an anticholinergic drug) which normally allowed the patient to attain the best control of symptoms one hour before being tested (19). Patients will perform both the stop-signal task and the go-only task. Experimental conditions will be counterbalanced across patients.
15897997|NCT03665480|Drug|G-SCF|In G-CSF treatment group, all patients are treated with G-CSF at the dose of 5ug/kg pre day until neutrophil higher than 0.5 g/L or 14 days from day three after induction therapy. MRD is monitored at day 14 and 28, respectively, with flow cytometry and quantity PCR if a fusion gene is available.
15897998|NCT03665454|Drug|PF-06412562|PF-06412562 is a dopamine agonist developed by Pfizer Inc. into a tablet form for oral usage. It will be provided as 5 mg tablets. Thus, to administer the 25 mg dose, 5 x 5 mg tablets will be given; and to administer the 20 mg dose, 4 x 5 mg tablets will be administered.
15897999|NCT03665454|Drug|Standard of Care Placebo|25/100 mg tablet(s) of carbidopa/levodopa will be encapsulated and administered according to the subject's home regimen.
15898000|NCT03665441|Drug|eryaspase|L-asparaginase encapsulated in erythrocytes (red blood cells)
15898001|NCT03665441|Drug|Gemcitabine plus Abraxane|gemcitabine, Abraxane
15898002|NCT03665441|Drug|Irinotecan plus 5-FU plus leucovorin|irinotecan, 5-FU, leucovorin
15898003|NCT03665428|Drug|PAMB treatment (modified quadruple therapy)|Randomly assign either as PAMB or PBMT group treatment
15898004|NCT03665428|Drug|PBMT treatment (bismuth-containing quadruple therapy)|Randomly assign either as PAMB or PBMT group treatment
15898005|NCT03665415|Behavioral|NDGameSquad|The intervention will be delivered within participants' homes. Participants will be provided a gaming console and exergames. Participants will be encouraged to meet a goal of 60 minutes/day of MVPA for the duration of the intervention by playing the exergames at least three times per week and engaging in non-screen based physical activity on other days. Participants will receive a booklet that includes a curriculum for playing weekly challenges. Participants will wear a FitBit during their exergaming sessions. Participants and parents meet bi-weekly with a health coach via video-chat using the exergame console. Sessions will identify and encourage specific physical activity, healthy eating, and healthy sleep habits. At the school site, participants will receive additional check-ins, engagement support, and health curricula from classroom teachers during the first 10 weeks of the intervention.
15898006|NCT03665402|Drug|Isoniazid|One of the first line anti-tubercolosis drug
15898007|NCT03665389|Device|iFR / FFR measurement|At the time of pre-TAVR coronary angiogram, iFR (iFR before TAVR) will be measured. The cCTA data collected from patients whose consent is obtained following TAVR will be anonymized and sent to HeartFlow, Inc., where the FFRct （FFRct before TAVR） values will be calculated using their cardiovascular dynamics analysis program. With the FFRct values blinded, FFR (FFR after TAVR) and iFR (iFR after TAVR) will be measured using a guide wire that is capable of sensing pressure after TAVR is performed. Furthermore, FFRct(FFRct after TAVR) is calculated from cCTA taken after TAVR.
15898008|NCT03665376|Dietary Supplement|Carbohydrate drink load|Administration of 5% Dextrose orally as a carbohydrate drink load two hours before surgery and as an oral sips eight hours after the surgery.
15898009|NCT03665376|Combination Product|Enhanced Recovery After Surgery (ERAS)|The ERAS intervention consisted of exposing patients to ERAS protocol of care as described by the ERAS Society® for the entire perioperative period. However, some of these ERAS protocols were modified to our local resources and requirements.
15898010|NCT03665363|Other|SCOPE|SCOPE is a internet-delivered, coach-guided, psychoeducational intervention, intended to serve as a first-line intervention for intellectually able adolescents and young adults with ASD. The SCOPE program is based on information comprising neuropsychology, pedagogy, and also interdisciplinary clinical experience regarding ASD. The content is aimed at providing information about typical and specific impairments of ASD, as well as the associated strengths.
15898011|NCT03665363|Other|Self-study|Active control consisting of directed self-studies on internet.
15898012|NCT03665350|Drug|Insulin|"Insulin as well as oral anti-diabetic drugs will be prescribed by the responsible physician and/or the diabetologist from each participating site, in conformity with the current guidelines, and the therapeutic target chosen according to patient characteristics.
~The choice of anti-diabetic medications should be guided by medical needs of each patient and taking into consideration their general safety profile."
15898013|NCT03665337|Behavioral|mTranS-C|MOBILE HEALTH
15898014|NCT03665337|Behavioral|Control|MOBILE HEALTH
15898015|NCT03665324|Other|Evaluation of the relationship between atrial remodeling evaluated by ECG and ETT with the occurrence of supraventricular arrhythmias|"Subjects will be retrospectively retrieved from the Sport Medicine Service of Rennes University Hospital database.
~Medical data will then be collected from the athletes' medical records. The ECG present in the medical file will be reinterpreted to obtain the resting heart rate, the amplitude of the P wave, the morphology of the P wave and the duration of the PR space.
~The data from the stress test will be found from reports in the medical records: resting heart rate, maximum heart rate, sustained peak load, arrhythmia during the test.
~ETTs will be retrieved from the local server. They will be reinterpreted to collect anatomical and functional cardiac data necessary for the study."
15898016|NCT03665311|Biological|25% Albumin fluid|25% Albumin fluid (100 mL)
15898017|NCT03665311|Other|Normal Saline|0.9% Normal Saline (100 mL)
15898018|NCT03665298|Behavioral|Smartphone Application|App that helps patients find syringe exchange programs, safe way to dispose of needles, access to naloxone kits and access to free medical care and addiction treatment programs.
15898019|NCT03665285|Drug|NC318|NC318 is an experimental antibody drug that may make the immune response more active against cancer.
15898020|NCT03665272|Procedure|deepithelialized gingival graft fixation|one group's deepithelialized gingival graft fixed by sutures and other one's by tissue adhesive.
15898021|NCT03665259|Procedure|Pure oxygen group|pre-oxygenation with 100% oxygen during induction of anesthesia
15918499|NCT03509012|Drug|Carboplatin (dose level 2)|IV
15898023|NCT03665246|Behavioral|Integrated Mothers and Babies Course|The Integrated Mothers and Babies Course/Early Childhood Development (iMBC/ECD) will be implemented along side normal C-PrES programming (key MNCHN behaviors). The iMBC curriculum is a prevention model based on cognitive behavioral therapy with the aim of supporting pregnant women and mothers with children under two years of age to become more resilient, decrease risk for future depression, and manage daily stressors effectively. In addition, the updated version of the iMBC is integrated with selected early childhood development (ECD) messages. The integration of these messages is intended to increase mothers' knowledge of the stressors associated with pregnancy and parenting young children and promote early stimulation behaviors and bonding to support child development.
15898024|NCT03665233|Device|VR|People in the VR-group get a VRH session during the CPM physiotherapy , people in the sham group get a VR sham session, while they both can enjoy Standard Treatment
15898025|NCT03665220|Other|Ergonomic adjustments|The ergonomic adjustments made were based on a prior assessment of the patient's needs in this respect, using a purpose-made home inspection form .
15898026|NCT03665220|Other|Kinesiotherapy plus ergonomic adjustments|This group received, in addition to the ergonomic adjustments described above, sessions of postural orientation and kinesiotherapy (therapeutic exercises).
15898027|NCT03665220|Other|Healthcare education|This group received health education information, based on an illustrated manual with advice for patients with chronic stroke.
15898028|NCT03665207|Drug|Insulin|When blood glucose exceeds the preset target, insulin will be administered through continuous intravenous infusion. Insulin will be titrated according to frequent measurement of blood glucose and with use of the LOGIC-insulin algorithm in the experimental group. The intervention will be stopped upon ICU discharge, or until the patient is able to resume oral feeding, or until the patient no longer has a central venous catheter, whatever comes first.
15898029|NCT03665194|Drug|Cortexolone 17α-propionate solution|Single topical application to be applied twice daily (0 hour and 12 hour) on Days 1-3 and Once Daily (0 hour) on Day 4.
15898030|NCT03665194|Drug|Placebo|matching placebo
15898031|NCT03665181|Other|use or non-use of dose modulator and bismuth mask|For each child for who the eligibility criteria are met, the CT exam is perfomed with or without dose modulator associated to with or without bismuth mask
15898032|NCT03665155|Drug|89Zr-daratumumab|2 mCi of 89Zr-daratumumab will be administered on day 0.
15898033|NCT03665155|Device|PET/CT scans|PET/CT images will be obtained on post-administration days 1, 2-4, 5-6, and/or 7-8 following administration of 89Zr-DFO-daratumumab to determine the optimal time point for imaging.
15898034|NCT03665155|Other|Blood draws|Blood and serum samples will be weighed and counted in a scintillation well counter calibrated for 89Zr. Immediately before or after each PET/CT imaging session,
15898035|NCT03665142|Other|Kinesio taping|Upper trapezius muscle stretching exercise with Kinesio taping (KT) was applied to the study group. KT was applied 8 times in total for 4 weeks with 2 sessions per week. Stretching exercise was done in the morning, afternoon and evening 3 times (repeated 10 times per set) every day for 4 weeks and 5 days of the week.
15898036|NCT03665142|Other|Exercise|Upper trapezius muscle stretching exercise was applied to the control group.
15898037|NCT03665129|Biological|IPH5401 and Durvalumab|IPH5401 and durvalumab
15898038|NCT03665116|Dietary Supplement|L-arginine|L-arginine capsule
15898039|NCT03665103|Other|Laser-assisted ICSI|Laser opening of the zona pellucida.
15898040|NCT03665090|Behavioral|Diabetic eye disease screening|Community-based, prospective cohort study from three consecutive years (2016 to 2018) to determine the prevalence and impact of diabetic eye disease, especially diabetic retinopathy (DR), in adults with diabetes living in Shanghai.
15898041|NCT03665077|Diagnostic Test|Initial blood draw|At baseline, patients will undergo a blood draw.
15898042|NCT03665077|Diagnostic Test|Initial SWE ultrasound|At baseline, patients will undergo a sheer wave elastrography (SWE) ultrasound of their hands including wrists.
15898043|NCT03665077|Diagnostic Test|Blood draw at three months|Blood drawn at three months to evaluate oxylipins.
15898044|NCT03665077|Diagnostic Test|Blood draw at six months|Blood drawn at six months to evaluate oxylipins.
15898045|NCT03665077|Diagnostic Test|SWE ultrasound at six months|SWE ultrasound at six months to evaluate tendon stiffness.
15898046|NCT03665051|Procedure|Muscle Tissue Biopsy|A biopsy of the Vastus Lateralis muscle will be performed on the left leg using the Bergstrom technique.The skin will be incised (approximately 0.75 cm) with a #11 scalpel, and the Bergstrom needle will be inserted into the Vastus Lateralis. Approximately 150 mg of muscle tissue will be obtained under suction. After the biopsy, pressure will be applied to stop bleeding and the skin will be closed with Steri strips (suture(s) if allergy to steri strips and removal 7-10 days post biopsy). A sterile dressing will be applied. Ace bandage may also be used along with applied pressure and an ice pack for any swelling and pain relief.
15898047|NCT03665051|Other|Maximal Oxygen Consumption (V02max)|Aerobic fitness will be determined by measuring maximal O2 consumption (VO2max) during a stationary bicycle exercise test. Heart rate, blood pressure and ECG will be recorded throughout this test. Subjects will breathe through a low resistance mouthpiece and wear a nose clip. Expired gases will be measured by indirect calorimetry and heart rate monitored by a portable heart rate monitor. Following a standardized warm up, subjects will begin exercising at a moderate intensity with the workload increased every minute until the subject can no longer continue. A leveling-off (plateau) or decline in oxygen uptake should be demonstrated in order to be reasonably sure that a subject has achieved the maximum capacity for aerobic metabolism.
15898048|NCT03665038|Drug|Brexanolone|Brexanolone
15898049|NCT03665025|Other|immediate implant using mixed allograft and xenograft|immediate implant using mixed allograft and xenograft in anterior area to fill jumping area
15898050|NCT03665012|Other|Pediatric Development Clinic (PDC)|All children enrolled in PDC will be at screened for any medical condition they may have and be referred for treatment as required. Nutrition and development support are also provided to clinic enrollees, based on clinic protocols which include regular monitoring and intervention.
15898051|NCT03664999|Diagnostic Test|Blood sampling|differences between dynamics of the complement components C1 inhibitor, C1 inhibitor activity, C3, C4 during the labour in a group of women with physiologic pregnancy and in a group with a risk of complications (pre-eclampsia, HELLP syndrome, placenta praevia, placental abruption, IUGR, previous post partum hypotony).
15898371|NCT03662412|Drug|Sirolimus|Oral solution of sirolimus, 2mg, once a day.
15898052|NCT03664986|Drug|Liposomal Bupivacaine|The objective of our study is to compare the use of EXPAREL in minimizing post-operative pain after sacrospinous ligament fixation with or without concomitant procedures for pelvic organ prolapse, with or without suburethral sling. We hypothesize that pudendal nerve blockage using long-acting EXPAREL will reduce post-operative pain and potentially reduce oral narcotic consumption. It may also reduce the incidence of postoperative constipation and patient satisfaction.
15898053|NCT03664973|Procedure|Serratus plane block|Local anesthetic infusion though a peripheral nerve catheter placed on the 5th rib under the serratus plane
15898054|NCT03664960|Drug|AK002|AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8.
15898055|NCT03664947|Other|exercise|After the initial evaluations, a video-based gaming console exercise program will be implemented for 8 weeks, taking into account the possibility of accepting and participating in treatment with children. Exercises applied by a Nintendo Wii Fit Plus System. Evaluations will be repeated at the end of treatment.
15898056|NCT03664934|Other|Exercises|Neck-specific exercises for chronic whiplash associated disorders
15898057|NCT03664921|Drug|Omnitram Oral Tablet|Administered three times daily for 28 consecutive days.
15898058|NCT03664921|Drug|Placebo Oral Tablet|Administered three times daily for 28 consecutive days.
15898059|NCT03664908|Other|Detection of circulating anti-GBM antibodies (using chemiluminescence method and indirect immunofluorescence (IIF) method).|biological detection of circulating anti-GBM antibodies (using chemiluminescence method and indirect immunofluorescence (IIF) method) in three serum samples groups, coming from SLE patients (having Lupus Nephritis or not) and in a control group.
15898060|NCT03664895|Drug|Leuplin or zoladex|OFS(Leuplin or zoladex) add on to TMX
15898061|NCT03664882|Drug|Fexofenadine M016455|Pharmaceutical form: tablet Route of administration: oral
15898062|NCT03664882|Drug|Placebo|Pharmaceutical form: tablet Route of administration: oral
15898063|NCT03664869|Drug|BCG instillation therapy|Induction period of six weekly instillations of BCG followed by maintenance period of ten monthly instillations of BCG
15898064|NCT03664869|Drug|Sequential BCG and EMDA mitomycin C|"Induction period includes nine weekly instillations of sequential BCG and EMDA-MMC instillations applied as three cycles of BCG, BCG and EMDA-MMC. Induction period is followed by maintenance period of nine monthly instillations of sequential EMDA-MMC and BCG applied with three cycles of EMDA-MMC, EMDA-MMC and BCG.
~BCG instillation is performed as a standard instillation.
~Mitomycin C is administered with electromotive drug administration (EMDA) device (Instillation: 40 mg mitomycin C with 960 mg of excipient sodium chloride dissolved in 100 ml sterile water, EMDA settings: current rise rate 30-50 microamperes per second, max 25 milliamperes, treatment duration 30 min)"
15898065|NCT03664856|Other|interview|The patient will be asked to answer the questions that the interviewer will ask him.
15898066|NCT03664830|Drug|Plerixafor|Up to two subcutaneous injections of plerixafor (starting dose level: 240 µg/kg/dose)
15898067|NCT03664817|Behavioral|social capital intervention|The social capital intervention will focus on developing skills and group-work that culminate in participant-derived photovoice projects. Each group of YBMSM will be encouraged to complete a 30 day photovoice challenge. The 30 day challenge is based on a prior community action project done as a part of our Centers for AIDS Research (CFAR)-funded research, which was a Photovoice project conducted by Dr. Hussen. Photovoice is a participatory action research methodology in which groups of individuals from a population of interest are given cameras to document events, people and places of significance in their lives.
15898068|NCT03664817|Behavioral|group-based health promotion intervention|"The control arm will participate in a health education intervention that will be delivered in a group, but without a specific goal of creating group cohesion or social capital. The intervention will be a modified version of Health for Life or H4L, which was used as a control arm intervention in a recently completed protocol of the Adolescent Trials Network which was co-chaired by Dr. Harper (University of Michigan)."
15898070|NCT03664791|Procedure|Vanguard Rocc|Patient operated with the Vanguard Rocc knee prosthesis
15898071|NCT03664765|Other|UA and RMT|daily oropharyngeal and respiratory muscle exercises
15898072|NCT03664765|Other|Sham exercise|Daily sham exercises
15898073|NCT03664752|Drug|IDP-120 Gel|Component A
15898074|NCT03664752|Drug|IDP-120 Vehicle Gel|Vehicle
15898075|NCT03664739|Drug|IDP-120 Gel|Component A
15898076|NCT03664739|Drug|IDp-120 Vehicle Gel|Vehicle
15898077|NCT03664726|Behavioral|Episodic Future Thinking|Participants will be instructed to use their episodic cues as they engage in different decision making tasks
15898078|NCT03664726|Behavioral|Episodic Recent Thinking|Participants will be instructed to use their episodic cues as they engage in different decision making tasks
15898079|NCT03664713|Behavioral|Eye Movement Desensitization and Reprocessing (EMDR) Therapy|EMDR is an 8-phase psychological treatment composed of protocols and standardized procedures applicable to both adults and children. The eight phases (patient history, patient preparation, evaluation of the main aspects of the memory, desensitization of the traumatic memory, installation of the positive cognition, body scan, close and re-evaluation) and the protocol of the time line of past-present-future, allow a holistic evaluation of the image of the traumatic memory, and allow for the patient to be well-prepared before processing past events which underlie current pathology, current situations which cause perturbation, and challenges and possible future stimuli which might lead to the appearance of symptoms. (Shapiro, 2014)
15898080|NCT03664700|Device|LMA Protector|The LMA Protector will be inserted when a supraglottic device is needed
15898081|NCT03664687|Drug|Zoledronate|Administered intravenously (IV)
15898082|NCT03664674|Drug|OTO-104|Single intratympanic injection of 12 mg dexamethasone
15898083|NCT03664674|Drug|Placebo|Single intratympanic injection of placebo
15898084|NCT03664661|Drug|BCMA nanobody CAR-T cells|"step 1: Collect 50-100ml of peripheral blood for culture of BCMA nanobody CAR- T cells. step 2. After 72 hours, pretreated with FC regimen, details as follow Cyclophosphamide 600-800mg/m2 for 2 days Fludarabine 25-30mg/m2 for 3 days. step 3: After another 48 hours transfusion the cells back to the patients the numbers of infused CAR T cells are 5x106 /kg for the first 3 patients, 1.5x107 /kg for the second 3 patients and 4.5x107 /kg for the third 3 patients.
~After finishing this, another 6 patients will be enrolled for observation of efficacy."
15898085|NCT03664648|Biological|HEPLISAV-B|This study is strictly observational. Administration of HEPLISAV-B, the schedule of office visits and all treatment regimens will be determined by the treating health care provider in the context of routine clinical care.
15898086|NCT03664635|Biological|MB-CART20.1|MB-CART20.1 consists of autologous CD20 Chimeric Antigen Receptor (CAR) transduced CD4 /CD8 enriched T cells targeting CD20-positive tumor cells in NHL
15898087|NCT03664622|Drug|Ketamine|Ketamine group to whom intravenous ketamine was administered in a loading dose of 0.15 mg/kg over 5 min, 10 minutes pre incision, followed-by an infusion at 2 micg/kg/min until the end of surgery.
15898088|NCT03664622|Drug|Morphine|a loading dose of 0.1 mg/kg over 20 min intravenously, 10 minutes pre incision, then infused with morphine an infusion rate of 5 - 40 microgram/kg/hour till the end of surgery.
15898089|NCT03664609|Device|Deep Brain Stimulation|Deep Brain Stimulation in patients with Parkinson Disease, Dystonia and Essential Tremor.
15898090|NCT03664596|Dietary Supplement|Sublimated mare's milk|Supplement obtained through sublimation of mare milk, packed into one-dosage sachet (20g), and dissolved in a warm water (36 degrees of Celcius).
15898091|NCT03664596|Drug|Ursodeoxycholic Acid|Ursodeoxycholic acid in the form of 250 mg capsule.
15898092|NCT03664583|Behavioral|ACHRU-Community Partnership Program (CPP)|The intervention is a 6-month community navigation and self-management program for patients with diabetes and at least one additional chronic condition, and their caregivers, to improve health outcomes. The intervention will be provided by an interprofessional team of providers and consists of six core components.
15898093|NCT03664570|Device|VIPUN Balloon Catheter|The VIPUN Balloon Catheter is a nasogastric balloon catheter consisting of a standard nasogastric double lumen Sump catheter and a balloon attached to this catheter. Once the catheter is advanced into the stomach, the balloon can be inflated. The inflated balloon dimensions and intraballoon pressure are such that intragastric motility can optimally be assessed without inducing epigastric symptoms.
15898094|NCT03664557|Device|ER Reboa TM Catheter|During cardiac arrest occlusion of descending aorta to redistribute CPR-generated blood flow to brain and coronaries
15898095|NCT03664544|Drug|MCI-186|30 mg MCI-186 will be administered intravenously over 60 minutes.
15898096|NCT03664531|Other|Purified gluten|1 low FODMAPs, vegan muesli bar containing purified gluten per day for 1 week, for a total of 10 g purified gluten per day.
15898097|NCT03664531|Other|Non-purified gluten (containing ATIs)|1 low FODMAPs, vegan muesli bar containing whole wheat flour with non-purified gluten per day for 1 week, for a total of 10 g non-purified gluten per day.
15898098|NCT03664531|Other|Nocebo|1 gluten-free, ATI-free, low FODMAPs, vegan muesli bar per day for 1 week. This is a nocebo because we expect that participants will feel worse even though there is no potential irritant.
15898099|NCT03664518|Drug|Eltrombopag|subjects will initiate treatment with 25 mg eltrombopag. Platelet counts is obtained weekly and dose adjustment should be done according to platelet counts. and maximum dose should not exceed 75 mg daily. Subjects whose platelet count between 50~150×109/L，the eltrombopag dose Maintain. platelet count between 150~250×109/L, need to reduce the dose of eltrombopag to the next lower dose or lower frequency. Subjects whose platelet count exceeds 250×109/L at any point during the treatment period, must have eltrombopag interrupted and increase the frequency of platelet monitoring to twice weekly, until platelet counts fall below 100×109/L.
15898100|NCT03664505|Device|Compression garment (manual)|Garment based on manual measurement
15898101|NCT03664505|Device|Compression garment (scan)|Garment based on scan measurement
15898102|NCT03664492|Other|Educational whiteboard video|Participants will be prompted to complete pre-questionnaire, followed by access to the video, with a prompt to complete the post questionnaire after. If they agree, they will receive 4 to 6 months later, a third questionnaire to complete. For those without access to the internet, we will offer to them view the video at the SickKids at their convenience.
15898103|NCT03664479|Device|4 channel Electrical Stimulation Device|electrical stimulation at muscles which related with deglutition
15898104|NCT03664466|Dietary Supplement|astaxanthin|astaxanthin capsules 12 mg twice daily
15898105|NCT03664466|Other|Placebo|placebo capsules twice daily
15898106|NCT03664453|Drug|omaveloxolone|Omaveloxolone 50 mg capsules
15898107|NCT03664440|Drug|Nevirapine|Patients were randomized 1:1 to continuation arm (NVP-based regimens). Tenofovir disoproxil fumarate (TDF) plus lamivudine (3TC) or emtricitabine (FTC) remained as the backbone of the regimens.
15898108|NCT03664440|Drug|Rilpivirine|Patients were randomized 1:1 to switch arm (NVP-based regimens were switched to RPV-based regimens). Tenofovir disoproxil fumarate (TDF) plus lamivudine (3TC) or emtricitabine (FTC) remained as the backbone of the regimens.
15898109|NCT03664414|Drug|pentoxifylline|Pentoxifylline or placebo will be prescribed three times a day with meals. All the participants will continue with the usual treatment. Time frame: two years
15898110|NCT03664401|Device|Kerecis Oral™|
15898111|NCT03664401|Other|Free Gingival Graft|A free gingival autograft from patient palate placed and secured on wound bed
15898112|NCT03664388|Drug|Dual antiplatelet therapy with ticagrelor/prasuglre|Compare bleeding and ischemic events according to the type and duration of dual antiplatelet therapy
15898113|NCT03664375|Other|Botulinum toxin type A|All patients in the experimental group received a BoNT-A injection. The injected total dose for individual patient in the experimental group was 100 units which is equivalent to approximately 300-500 Units of Dysport (the other type of BoNT-A available). The Botox was injected by the neurophysician intramuscularly using insulin U100 syringe and determination of muscles for injection was assessed clinically.
15898114|NCT03664375|Other|Task Specific Training|Task specific training is the repetition of a specific task until expertise is reached. More challenging tasks are added as a means of progression
15898115|NCT03664362|Behavioral|The BSHAPE Intervention|The BSHAPE intervention program key elements include strengths based assessments, individualized plans and support based on priorities and needs, motivational interviewing strategies, psychoeducation (education with skill building exercises), mindfulness activities, danger assessment, safety planning, behavioral activation and linkage to community resources
15898116|NCT03664349|Device|SuperEar9000|Handheld hearing amplifier, not FDA regulated.
15898117|NCT03664323|Biological|Evaluate the improvement in response from the end of anti-PD-1 monotherapy|Evaluate the improvement in response from the end of anti-PD-1 monotherapy to the first evaluation after introduction of CT alone (Group 1) or combined with anti-PD-1 (Group 2).
15898120|NCT03664297|Drug|SHR1459|SHR1459 will be administered continually till disease progression or unacceptable toxicity.
15898121|NCT03664284|Procedure|subcutaneous disinfection|The investigators will randomize 105 patient on two arms. The control group receiving no disinfection of the subcutaneous tissue (A) and intervention group, receiving disinfection of the subcutaneous tissue (B).
15898122|NCT03664271|Behavioral|in-clinic video intervention|Video with information about eczema and eczema treatment, to be watched in clinic and at home
15898123|NCT03664271|Behavioral|at home video intervention|Video with information about eczema and eczema treatment, to be watched at home only
15898124|NCT03664258|Diagnostic Test|Xpert Bladder Cancer Monitor|The Xpert Bladder Cancer Monitor Assay is a qualitative in vitro diagnostic test designed to monitor for the recurrence of bladder cancer in patients previously diagnosed with bladder cancer. It should be used in conjunction with other clinical measures to assess disease recurrence. The test provides a fast and accurate result, is non-invasive and easy to perform.The test utilizes a voided urine specimen and measures the level of five target mRNAs (ABL1, CRH, IGF2, UPK1B, ANXA10) by means of real-time, reverse transcription-polymerase chain reaction (RT-PCR).
15898127|NCT03664219|Other|isolation of IAN from implant with collagen membrane|comparing between the neurosensory disturbances with and without isolation of the inferior alveolar nerve from implant
15898128|NCT03664206|Diagnostic Test|MRS, conventional TMS and treshold tracking TMS|"Using
~two MagStim 200 magnetic stimulator and a figure-of-eightc double 70 mm coil
~SPECIAL MR Spectroscopy sequence
~In addition, each group will undergo neurological examination"
15898129|NCT03664193|Radiation|SIBRT|Patients will receive 35 Gy in 5 fractions. Also, patients will receive 0.5-2 Gy per fx for a total dose of 37.5, 40, 42.5, or 45 Gy. Patients will also have an option to have a rectal balloon or a rectal spacer prior to receiving radiation therapy.
15898130|NCT03664180|Drug|Bivalirudin|IV infusion of 0.2 mg/kg/h (low-rate infusion) for at least 48h after the procedure or until discharge from CCU if it occurs later
15898131|NCT03664180|Drug|Enoxaparin|40mg/d s.c.for at least 48h after the procedure or until discharge from CCU if it occurs later
15898132|NCT03664180|Drug|Unfractionated heparin|IV infusion of 10 U/kg/h (maximum 1000 U) initially, adjusted to maintain ACT between 150 and 220 seconds for at least 48h after the procedure or until discharge from CCU if it occurs later
15898133|NCT03664180|Drug|Bivalirudin placebo|Matching placebo IV infusion for at least 48h after the procedure or until discharge from CCU if it occurs later
15898134|NCT03664180|Drug|Enoxaparin placebo syringe|Placebo syringe will be only prepared by a designated unblended medical professional on site. Placebo syringe will be presented in identical containers as a clear, colorless, sterile liquid of saline.Subcutaneous injection once a day for at least 48 hours after the procedure or until discharge from CCU if it occurs later.
15898135|NCT03664180|Drug|Unfractionated heparin placebo|Matching placebo IV infusion for at least 48h after the procedure or until discharge from CCU if it occurs later.
15898136|NCT03664167|Dietary Supplement|intensive weight loss diet, with Cambridge weightplan products, and visits to a dietician.|intensive weight loss diet, with Cambridge weightplan products, and visits to a dietician.
15898137|NCT03664154|Behavioral|Stress and Feeding (SAFE)|"The Stress Management component of the intervention acknowledges the mind-body connection between stress and adverse outcomes and consists of four web-based modules based on Lazarus and Folkman's Transactional Model of Stress and Coping designed to improve health outcomes.
~The Guided Feeding component of the intervention is based on the synactive theory of development. The synactive theory of development provides insight in to reading the physiological and behavioral cues of infants born preterm and involves weekly viewing of video clips of adaptive and maladaptive feeding behaviors of mothers and infants, practice opportunities, and follow-up phone calls."
15898138|NCT03664141|Drug|Cannabis oil|Treatment with cannabis oil
15898139|NCT03664141|Drug|Placebo/ Regular Oil|Treatment with placebo (Regular Oil)
15898140|NCT03664128|Other|Coping with Anxiety through Living Mindfully (CALM) Pregnancy|Mindfulness-based Cognitive Behavioral Therapy (CBT) for perinatal anxiety on a subset (8 participants); no intervention for other participants
15898141|NCT03664115|Drug|Itraconazole 200 mg|itraconazole 200 mg oral tablet daily, on a 21-day cycle.
15898142|NCT03664115|Drug|Chemotherapy|"intravenous doses of cisplatin 80 mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8 every 3 weeks for a maximum of 6 cycles.
~Alternatively, Carboplatin may be used instead of Cisplatin, Carbplatin AUC 5 DAY 1 only Dose = AUC x (GFR + 25) IV in 250 mL Normal Saline over 30 minutes"
15898143|NCT03664102|Device|Cor Knot|Heart valve replacement with or without the use of automated fastener device Cor Knot
15898144|NCT03664089|Behavioral|Ankle weights (2.5 pounds [1.1 kg]/ankle)|Women will receive the standard recommendation for engaging in 150 minutes of physical activity per week, ankle weights (2.5 pounds [1.1 kg]/ankle), documentation for ankle weight usage, an accelerometer, and instructions for accelerometer usage.
15898145|NCT03664089|Behavioral|Control|Women will receive the standard recommendation for engaging in 150 minutes of physical activity per week.
15898146|NCT03664076|Diagnostic Test|COMISS score|cow's milk protein symptoms score awareness tool to select cow's milk protein allergy in infants
15898147|NCT03664063|Drug|Azithromycin|Treatment with Azithromycin single dose - weight based dosing max 2gm
15898148|NCT03664063|Drug|Albendazole|"Single dose of Albendazole weight based dosing
~- 400mg"
15898149|NCT03664063|Drug|Ivermectin|Ivermectin weight based dosing - max 21mg
15898150|NCT03664063|Drug|Diethylcarbamazine|Diethylcarbamazine weight based dosing - max 500mg
15898151|NCT03664050|Drug|group A 2.5 mg letrozole oral tablets|2.5 mg letrozole oral tablets will be administered on the 2nd-3rd day of menses and then every day for 5 days. Treatment will be repeated for up to three cycles if the patient failed to conceive.
15898152|NCT03664050|Procedure|laparoscopic ovarian drilling|Bilateral laparoscopic ovarian drilling, each ovary will be cauterized at 4 points, each for 4 sec at 40 W, at a depth of 7-8 mm and a diameter of 3-5 mm, using a monopolar electrosurgical needle according to the size of each ovary.
15898216|NCT03663491|Procedure|Oral Gastroscopy, sedated|Use of transoral endoscopes for routine gastroscopy in adults. Use of intravenous sedation.
15898153|NCT03664037|Drug|Dexamethasone phosphate|each patient received 8 mg of intravenous DEX diluted in 100 ml 0.9% sodium chloride (normal saline [NS]) intravenous infusion (IVI) over 15 min 2 hours preoperatively
15898154|NCT03664037|Drug|Placebo|each patient received 100 mL 0.9% NS IVI over 15 min (Placebo) 2 hours preoperatively
15898155|NCT03664024|Drug|Pembrolizumab|Pembrolizumab, 200 mg, Day 1 of each 21-day cycle (Q3W), intravenous infusion (IV), standard of care in most countries
15898156|NCT03664024|Drug|Pemetrexed|Pemetrexed, 500 mg/m^2 infusion, standard of care, Q3W, IV
15898157|NCT03664024|Drug|Carboplatin|Carboplatin AUC 5 mg/mL/min, IV infusion, Day 1 of each 21-day cycle for 4 cycles (Cycles 1 - 4). Investigator's choice of either cisplatin or carboplatin.
15898158|NCT03664024|Drug|Cisplatin|Cisplatin, 75 mg/m^2, IV infusion, Day 1 of each 21-day cycle for 4 cycles (Cycles 1 - 4). Investigator's choice of either cisplatin or carboplatin.
15898159|NCT03664011|Drug|BI 730357 mixed with [C-14]BI 730357 BS|Oral Solution
15898160|NCT03663998|Biological|CN54ENV DNA|"CN54ENV DNA concentration 4 ± 0.7 mg/mL is formulated in 1 x PBS
~All administrations of CN54ENV will be by in vivo electroporation using the Ichor Medical Systems TriGrid Delivery System for intramuscular (TDS-IM) or intradermal use (TDS-ID) and will be delivered into the upper thigh(s)."
15898161|NCT03663998|Biological|GENEVAX® IL-12 DNA|"GENEVAX® IL-12 DNA, concentration 2 mg/mL with a fill volume of 1.0 mL (1.0 ± 0.1mL), is formulated in 30 mM citrate buffer.
~GENEVAX® IL-12 DNA is mixed with the CN54ENV DNA immediately prior to administration."
15898162|NCT03663985|Other|Groupe FALCOn|The objective of the study is to determine what are the anthropo-sociological factors in the surgeon, the oncologists and radiotherapists influencing decision making in ENT carcinology.
15898163|NCT03663972|Behavioral|articulation therapy|children receive instruction in producing new sounds at the isolation, syllable and word level.
15898164|NCT03663972|Behavioral|phonologic treatment|children receive instruction in producing new sounds at the word level
15898165|NCT03663959|Procedure|vaginal sacrospinous fixation procedure with dr.Aksakal's desta suture carrier|A right sacrospinous fixation using Dr. Aksakal's Desta suture carrier with two permanent sutures that combined the sacrospinous ligament and vaginal cuff fascia was done. The Desta suture carrier was developed for deep pelvic surgery, and the suture depth can be easily adjusted. After the vaginal hysterectomy, under the vaginal cuff mucosa, we created a tunnel through the spinous process with a straight tool. After passing the rectovaginal pillars, the perirectal space was entered and the ischial spine was palpated. With the help of an index finger placed on the spinous process, we placed two permanent sutures 1.5-2 cm medial to the spinous process on the sacrospinous ligament and iliococcygeus muscle complex using the Desta suture carrier. Next, permanent sutures were combined with the pubocervicovaginal and rectovaginal fascia under the vaginal cuff mucosa.
15898166|NCT03663959|Procedure|Laparoscopic Pectocolpopexy procedure|First, the peritoneal layer above and lateral to the bladder was opened parallel to the round ligament toward the pelvic side wall on the right side. Then, with the guidance of the obliterated umbilical artery, lateral to the obliterated umbilical artery and medial to the external iliac vein, the iliopectineal ligament was found . At this point, a segment of approximately 3-4 cm2 was formed, exposing the iliopectineal (Cooper's) ligament. In this area, behind the obliterated umbilical artery, the obturator nerve could be seen, and special care was given not to make contact with the nerve. The same area on the left side was prepared using the same steps. Then, anterior part of the vaginal cuff was prepared for mesh fixation. Bilaterally, the ends of a polypropylene monofilament mesh (1,5x15 cm) were fixed to the iliopectineal ligament with nonabsorbable polypropylene or polyester sutures . The vaginal cuff was elevated to POP-Q level 0-1.
15898167|NCT03663946|Other|Non-Interventional|Non-Interventional
15898172|NCT03663907|Procedure|Telemonitoring|"The system (the home tele-healthcare platform) designed jointly by engineers and clinical personal to be able daily automated selfreported symptom and weight, blood pressure and heart rate monitoring. The system allow weekly follow up through videoconferences.
~Information from the telemonitoring system is automatically downloaded to a secure Internet site for review by clinicians and nurses daily."
15898173|NCT03663881|Drug|P2Et extract|P2Et extract daily doses. Dosage scaling will be performed according to the 3 + 3 standard design.
15898174|NCT03663868|Diagnostic Test|CC-Test|Classification of the oocyte/embryo based on the gene expression pattern observed in the cumulus cells
15898175|NCT03663855|Drug|7 Days Tiopronin|On day 7 of this period,patients will be asked to perform a 24-hour urine collection to measure the urinary cystine levels.
15898176|NCT03663855|Drug|500 mg Tiopronin|5 tablets a day (200mg tab AM and 300mg tab PM). On day 7 of this period, you will perform a 24-hour urine collection.
15898177|NCT03663855|Drug|1 grams per day of Tiopronin|5 tabs twice a day (100mg per tab). Patients will have another 24-hour urine collection on day 7 of this period.
15898178|NCT03663855|Drug|2 grams per day of Tiopronin|10 tabs twice a day (100mg per tab). On day 7 of this period, patients will perform the final 24-hour urine collection.
15898179|NCT03663842|Other|Physical therapy treatment|All patients underwent the same techniques, and there was no modification of the intervention protocol during the study: (1) Myofascial release technique - piriformis muscle and biceps femoral muscle; (2) Hip joint mobilization; (3) Cross-fiber friction over the sacroiliac joints; (4) Neural mobilization to improve sciatic nerve excursion.
15898180|NCT03663829|Other|Non-Interventional|Non-Interventional
15898181|NCT03663829|Other|Non-Interventional|Non-Interventional
15898372|NCT03662399|Device|Insoles|Orthotic Insoles
15898182|NCT03663816|Device|experimental foot device|Appropriately-designed, stimulatory - but not mechanically supportive -device to enhance control of balance, postural sway and key features of walking gait in healthy people.
15898183|NCT03663803|Behavioral|Brief theory-based health promotion intervention (group-based)|The intervention is depicted using a PaT Plot in the published paper: Juul, L et al. Effectiveness of a brief theory-based health promotion intervention among adults at high risk of type 2 diabetes: One-year results from a randomised trial in a community setting. Primary Care Diabetes 1 0 ( 2 0 1 6 ) 111-120.
15898184|NCT03663790|Other|Foot Progression|The intervention will be a gait retraining biofeedback focused on foot angle during gait trials
15898185|NCT03663790|Other|Trunk Lean|The intervention will be a gait retraining biofeedback focused on trunk lean angle during gait trials
15898186|NCT03663777|Other|Isometric handgrip training|Intervention period will last 12 weeks. Experimental group will perform three sessions per week of home-based handgrip exercise. The exercise protocol will consist of eight sets of bilateral handgrip contraction of two minutes of isometric contraction, with 30% of maximum voluntary contraction, and two minutes of interval between sets. Patients will receive a diary to record the sessions and report difficulties during the training. The patients be recommended to increase daily physical activity levels, and weekly, there will be phone contacts with the patients to reinforce the exercise recommendations.
15898187|NCT03663777|Other|Control Group|Intervention period will last 12 weeks. Patients will be recommended to increase daily physical activity levels, and weekly, there will be phone contacts to reinforce the recommendations.
15898188|NCT03663764|Drug|Thymosin a1|All patients received weekly thymosin a1(1.6mg) during and within 2 months after the end of chemoradiotherapy.
15898189|NCT03663751|Drug|Decitabine|low-dose decitabine: 5mg/m2 daily for 5 days
15898190|NCT03663738|Behavioral|mobile app NOVAME|The training program is divided into 3 periods of 21 days, where each day the patient receives a new formation pill. At the end of one of these periods there will be a week of review in which the patient will receive reminders of the contents that he has already received. These pills will help the patient to acquire healthy lifestyle habits and improve the control of the disease. The length of the program is 84 days, and once completed, the patient can repeat or intensify efforts in the areas he considers and continue to have access to the virtual coach. Patients assigned to the intervention group will receive a brief structured explanation on how to use the application and its contents.
15898191|NCT03663725|Drug|Intensified protocol|Early Temozolomide (TMZ) 1 cycle (150 mg/m²/ day X 5 days, per os) Started between day 2 and 15 after surgery/ biopsy RT (60 Gy, 2 Gy/fraction) + concomitant TMZ (75 mg/m2/day X 42 days, per os) Started between W4 and W6 after surgery/ biopsy Adjuvant TMZ 6 cycles (150-200 mg/m2 X 5 days /month, per os) Started 1 month after the end of the concomitant TMZ Prolonged TMZ Until progression, intolerance, patient's or physician's decision (150-200 mg/m2 every 4 weeks, per os)
15898192|NCT03663725|Drug|Stupp protocol|RT (60 Gy, 2 Gy/fraction) + concomitant Temozolomide (75 mg/m2/day X 42 days, per os) Started between W4 and W6 after surgery/ biopsy Adjuvant TMZ 6 cycles (150-200 mg/m2 X 5 days /month, per os) Started 1 month after the end of the concomitant TMZ
15898194|NCT03663699|Behavioral|Exergaming|free access to the exergaming platform PlayPulse for 24 weeks
15898195|NCT03663686|Drug|Litapiprant Tablet|Small molecules inhibitors of the chemoattractant receptor homologous molecule expressed on Th2 cells
15898196|NCT03663673|Drug|EpiCeram|To compare skin barrier function, assessed by TEWL AUC, between non-lesional areas of the skin treated with EpiCeram®, Aveeno Daily Moisturising Sheer Hydration Lotion®, and no emollient use over a period of one week.
15898197|NCT03663673|Drug|Aveeno Daily Moisturising Sheer Hydration Lotion®|To compare skin barrier function, assessed by TEWL AUC, between non-lesional areas of the skin treated with EpiCeram®, Aveeno Daily Moisturising Sheer Hydration Lotion®, and no emollient use over a period of one week.
15898198|NCT03663660|Other|Organizational infrastructure pediatric plan (OIPP)|Restructuration of the hospital sectors with a stratification of health care into 4 levels.
15898199|NCT03663634|Other|Cytochalasin B use in ICSI handling medium|A medium with in-house supplementation of Cytochalasin B to decrease oocyte degeneration after ICSI and improve survival rate
15898200|NCT03663608|Procedure|WALANT Technique|pure local anaesthesia and without use of a tourniquet (WALANT Technique) for trigger finger release surger
15898201|NCT03663595|Other|Model 1|Model 1 will be composed of exercises focusing on local (knee) and proximal (hip) factors.
15898202|NCT03663595|Other|Model 2|Model 2 will be composed of exercises focused on the local (knee) and distal (ankle and foot) factors.
15898203|NCT03663582|Drug|Teduglutide|Teduglutide 0.05 mg/kg SC injection will be administered once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm.
15898204|NCT03663582|Device|Syringe|Teduglutide will be administered using syringe. Syringe is approved for use in Japan by Pharmaceuticals and Medical Devices Agency (PMDA).
15898205|NCT03663582|Device|Needle|Teduglutide will be administered using needle. Needle is approved for use in Japan by PMDA.
15898206|NCT03663582|Device|Vial Adapter for Device|Vial adapter for device is approved for use in Japan by PMDA.
15898207|NCT03663569|Drug|Spiolto® Respimat®|Drug
15898208|NCT03663556|Other|Infant-feeding|Preterm infants hospitalized in the NICU can be feed by three different types of infant feeding, such as breast milk, donor human milk and/or formulas.
15898209|NCT03663543|Drug|Conjugated Estrogen|Dosing of conjugated estrogen will be given pre kidney transplant procedure and twice after reperfusion of the transplanted kidney.
15898210|NCT03663543|Drug|Normal saline|Dosing of normal saline will be given pre kidney transplant procedure and twice after reperfusion of the transplanted kidney.
15898211|NCT03663530|Behavioral|Meal times|Meal times vary based on the arm: aligned or misaligned
15898212|NCT03663504|Other|No Preparation|No preparation before surgery
15898213|NCT03663504|Drug|Neomycin and Flagyl|Oral antibiotic (Neomycin and Flagyl) taken the day before the surgery
15898214|NCT03663491|Procedure|Nasal Gastroscopy|Use of transnasal endoscopes for routine gastroscopy in adults.
15898215|NCT03663491|Procedure|Oral Gastroscopy, unsedated|Use of transoral endoscopes for routine gastroscopy in adults. Use of local anesthesia.
15898217|NCT03663491|Procedure|Oral Gastroscopy with transnasal endoscope, sedated|Use of transnasal endoscopes for routine gastroscopy in adults, following a failed attempt to perform transnasal gastroscopy
15898218|NCT03663478|Drug|Ropivacaine|2 x 30 ml ropivacaine 0,2% and an elastomere pump with 200 ml ropivacaine 0,2%, infusion rate 8 ml/hour
15898219|NCT03663478|Drug|Saline|2 x 30 mL isotonic saline and an elastomere pump with 200 ml isotonic saline, infusion rate 8 ml/hour
15898220|NCT03663465|Other|Hawthorn|Hawthorn tablet
15898221|NCT03663465|Drug|SGAs|SGAs tablet
15898222|NCT03663452|Behavioral|Targeted Assessment and Context-Tailored Implementation of Change Strategies (TACTICS)|TACTICS begins with a mixed methods assessment (using data from medical records, staff surveys, and staff interviews) to identify barriers and facilitators of PE use in each clinic. From a menu of implementation strategies that can be matched to local conditions, an implementation plan is developed in collaboration with clinic personnel and deployed to address specific barriers and leverage strengths at each clinic site over a 5-month period.
15898223|NCT03663452|Behavioral|Prolonged exposure training|Providers will receive a 2-day workshop training in the delivery of prolonged exposure, followed by weekly phone clinical consultation.
15898224|NCT03663439|Procedure|modified shell technique|divided block of bone into two shells and grafting one shell in anterior maxilla
15898225|NCT03663426|Procedure|study group|"High dose corticoids pre-operative and 24h postoperative
~Opioid free general anesthesia
~Avoid opioids post-operative by continue clonidine, ketamine and lidocaine, only exceptional opioids after NSAID and paracetamol."
15898226|NCT03663426|Procedure|control|"No corticoids pre-operative.
~Opioid anesthesia
~Opioids post-operative after NSAID and paracetamol."
15898227|NCT03663413|Device|non-invasive monitor|cutaneous EEG monitor
15898228|NCT03663400|Diagnostic Test|GWAS analysis by Illumina BeadChip|will generate comprehensive genotype data for patients. Samples will be used for transcriptional profiling, microbiota profiling by 16S analysis and immunological profiling by flow cytometry
15898229|NCT03663374|Drug|Odelepan|Tablets, 125 mg
15898230|NCT03663374|Drug|Placebo|Contains the same excipients as Odelepran but it does not contain the active agent. Placebo is identical to Odelepran in terms of drug form and external characteristics (colour, smell, etc). Doses and route of administration are identical to those for Odelepran.
15898231|NCT03663361|Other|SMART Intervention|Ankle rehabilitation with the addition of sensorimotor components
15898232|NCT03663361|Other|Standard of Care Intervention|Ankle rehabilitation focused on restoring range of motion, strength and balance
15898233|NCT03663335|Biological|CFZ533 - MMF - CS|Comparison with standard of care immunosuppression
15898234|NCT03663335|Drug|Tacrolimus - MMF - +/- corticosteroids|Standard of care immunosupprevive regimen
15898235|NCT03663322|Procedure|OMT Protocol|Selected hands-on OMT techniques intended to improve pancreatic function will be administered during the treatment sessions
15898236|NCT03663322|Procedure|OMT-Sham Protocol|Selected hands-on Sham-OMT techniques that are not intended to affect pancreatic function will be administered during the treatment sessions
15898237|NCT03663309|Diagnostic Test|detecting Gluten peptides in faecal and urine samples|"At each visit patient will:
~Bring 4-day food diary (attached)
~Fill symptoms and complaints questionnaire (attached)
~Provide 24 h diet recall in case a food diary absents
~Fill Biagi score questionnaire (attached)
~Perform blood test of TTG
~Provide stool and urine samples"
15898238|NCT03663296|Other|Airway Ex App|30 minutes of self-directed learning and practice using the mobile application
15898239|NCT03663283|Drug|Liposomal Bupivacaine|Interscalene Nerve Blocks
15898240|NCT03663283|Drug|Bupivacaine Hydrochloride|Interscalene Nerve Blocks
15898241|NCT03663270|Device|Hypotension probability index (HPI)|The intervention group is managed with the HPI parameter to detect and possibly prevent hypotension during anaesthesia.
15898242|NCT03663257|Device|AneurysmFlow|AneurysmFlow R1.0 is an approved (CE labeled, cleared in US, Canada and Argentina), software tool intended to provide relevant information on the blood flow in a cerebral aneurysm and its parent artery based on angiography. It provides color coded and vector field representation of a digital subtraction angiography (DSA). It can quantify blood flow rates in the artery based on DSA and 3-D Rotational Angiogram (3DRA) data. It can visualize blood flow patterns in an aneurysm based on DSA data. Specifically, it calculates the Mean Aneurysm Flow Amplitude (MAFA) ratio to measure the volumetric flow rate quotient before and after Flow Diverter Stent (FDS) implantation in the region of interest. It is manufactured by Philips Medical Systems B.V., a Philips Healthcare company.
15898243|NCT03663244|Behavioral|MBSR|Standardised stress reduction programme with established efficacy
15898244|NCT03663244|Behavioral|LSR|Existing stress reduction programme in a Danish municipality
15898245|NCT03663231|Device|Biotene|Biotène Dry Mouth Moisturizing Spray contains water, polyglycitol, propylene glycol, sunflower oil, xylitol, milk protein extract, potassium sorbate, acesulfame K, potassium thiocyanate, lysozyme, lactoferrin, lactoperoxidase. 3 sprays, approximately 15 mL.
15898246|NCT03663231|Device|Placebo|IND/IDE exempt device primarily water
15898247|NCT03663218|Radiation|Dose escalation|This is a modified dose escalation and de-escalation study with an expansion of 3 or 6 pts to allow the recommended phase II dose (RP2D) be examined in a total of 9 pts. The dose limiting toxicity (DLT) is defined as Grade 3 or higher toxicity related to preoperative radiotherapy according to the Clavien-Dindo Classification. 3 radiation dose levels, 5 Gy, 6 Gy and 6.5Gy are considered. At the start of each dose level, 3 pts will be enrolled and treated for five days. If none of the 3 pts develop the DLT, the testing dose will escalate to the next level. If 1 of the 3 pts develops the DLT, the current dose will be tested in an additional 3 pts. If no additional pts develop the DLT, the dose will escalate.
15898250|NCT03663192|Device|strain echocardiography|strain echocardiography during septic shock
15898278|NCT03662984|Drug|Ciprofibrate 100Mg Tablet|Ciprofibrate is a PPARα ligand and is considered to be a major regulator of the lipid metabolism. PPARα regulates the genes involved in mitochondrial function and fat metabolism and is therefore abundantly expressed in tissues that require high rates of FFA oxidation, like for instance in the heart and activation of PPARα in the heart may have beneficial effects on mitochondrial function and fat oxidative capacity.
15898251|NCT03663179|Device|Transcranial Magnetic Stimulation (TMS)|A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. TMS will be administered at 10 Hertz (Hz) with an intensity of 120% of patient resting motor threshold. Stimulation will be delivered to the left dorsolateral prefrontal cortex using 20 sec cycles (i.e., 5 sec train with 15 sec inter train interval). Subjects will receive 80 trains per session for a total of 4000 pulses per session (~26 min sessions). Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks).
15898252|NCT03663179|Device|Sham Transcranial Magnetic Stimulation (Sham TMS)|A MagPro R30 (Magventure, Inc., Copenhagen, Denmark) device with a Cool-B65 A/P figure 8 coil will be used to deliver TMS. This coil has an active side and a sham side, and can be used to perform double-blinded studies. For sham stimulation, the sham side of the coil is positioned toward the participant's scalp. The sham coil is designed to mimic the appearance and sound of active TMS stimulation, but is equipped with a magnetic shield that reduces the strength of the field by approximately 80%. This reduction in field strength ensures that no neural stimulation occurs. Twenty sessions will be completed on sequential weekdays (5 days per week for 4 weeks).
15898253|NCT03663166|Radiation|Thoracic Radiotherapy|2 Gy in 30 fractions directed at all sites of suspected disease
15898254|NCT03663166|Drug|Platinum Based Chemotherapy|Platinum based chemotherapy including cisplatin and etoposide, carboplatin and paclitaxel or cisplatin and pemetrexed (for patients with non-squamous histology).
15898255|NCT03663166|Drug|Ipilimumab|Iplimamab 1mg/kg delivered concurrently with initiation of chemoradiotherapy and in week 4 of chemoradiotherapy
15898256|NCT03663166|Drug|Nivolumab|Nivolumab 480 mg (30 minute IV infusion) at least 7 days but no more than 21 days after completion of radiation and chemotherapy every 4 weeks for up to 12 cycles.
15898257|NCT03663153|Other|SEMA4C high value follow-up group|Serum samples will be collected every 3 months for the first year after surgery and then every 6 months to first progression defined as death or recurrence of the breast cancer or until 5 years since last patient in, whichever occurs first. Imaging examination and biopsy or surgery if necessary are recommended for patients with elevated SEMA4C. Serum SEMA4C levels will be tested in single center in order to decrease bias and be measured using a double antibody sandwich ELISA method using in-house SEMA4C detection kits.
15898258|NCT03663153|Other|SEMA4C low value follow-up group|Serum samples will be collected every 3 months for the first year after surgery and then every 6 months to first progression defined as death or recurrence of the breast cancer or until 5 years since last patient in, whichever occurs first. Imaging examination and biopsy or surgery if necessary are recommended for patients with elevated SEMA4C. Serum SEMA4C levels will be tested in single center in order to decrease bias and be measured using a double antibody sandwich ELISA method using in-house SEMA4C detection kits.
15898259|NCT03663140|Diagnostic Test|gingival crevicular fluid (GCF) and peri-implant sulcular fluid(PISF) collection|GCF/PISF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva.
15898260|NCT03663127|Dietary Supplement|Beauty Drink|"Subjects receive two bottles of Beauty Drink per day for 8 weeks of a stage. Anthropometric measurements such as blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), body weight, body fat, waistline, hips, and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST, and ALT were measured every four weeks."
15898261|NCT03663127|Dietary Supplement|Placebo|Subjects receive two bottles of placebo of similar appearance per day for 8 weeks of a stage. In addition, anthropometric measurements such as blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]), body weight, body fat, waistline, hips, and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST, and ALT were measured every four weeks.
15898262|NCT03663114|Drug|Lenvatinib|Lenvatinib capsule
15898263|NCT03663101|Drug|Lidocaine|0.5 mL (2.5 mg) of lidocaine per injection point will be injected subcutaneously (maximum 10 injection points).
15898264|NCT03663101|Biological|Botulinum toxin type A|0.2 mL of one of three different doses of Dysport per injection point will be injected intradermally (maximum 10 injection points).
15898265|NCT03663101|Drug|Placebo|Part A - 0.5 mL of sodium chloride solution 0.9% (saline solution) per injection point will be injected subcutaneously (maximum 10 injection points).
15898266|NCT03663101|Drug|Placebo|Part B - 0.2 mL of sodium chloride solution 0.9% (saline solution) per injection point will be injected intradermally (maximum 10 injection points, 2,0 mL maximum).
15898267|NCT03663088|Other|GPR-A|Standard Global postural re-education physiotherapy scoliosis specific exercises
15898268|NCT03663088|Other|GPR-B|Experimental Global postural re-education physiotherapy scoliosis specific exercises combining individual and class exercises
15898269|NCT03663075|Behavioral|Group information (GI)|The group education consists of four information sessions discussing myths and myths around menopause, physiology, local estrogen deficiency symptoms, women's cardiovascular health, stress-related ill health, mental health, relationships, sexuality, lust and possible treatment options. In addition, conversations about insight into obstacles and resources, coping strategies and behavioral changes will be included.
15898270|NCT03663075|Behavioral|Structured person-centered support (PCS)|The individually structured person-centered support comprises of five meetings consisting of dialogue on symptoms of stress-related ill health, physiology and coping strategies.
15898271|NCT03663062|Diagnostic Test|Colonoscopy|All patients would undergo colonoscopy as part of standard care. Patients recruited for this study would have their past medical history, family history, medication history, as well as waist circumference, BMI and blood pressure recorded. All patients would also have blood tests (described earlier) and a subset will undergo Fibroscan.
15898272|NCT03663049|Drug|discontinue statin|Discontinue statin as prescribed for 12 weeks
15898273|NCT03663036|Diagnostic Test|Magnetic Resonance Imaging of the shoulder|Clinical and radiological assessments of the shoulders and the donor sites
15898274|NCT03663023|Procedure|Intestinal obstruction|
15898275|NCT03662997|Device|Bordered Five-Layer Foam Dressing|Bordered, five-layer, flexible foam dressing with soft silicone adhesive technology
15898276|NCT03662997|Device|Hydropolymer Foam Dressing|Hydropolymer, adhesive foam island dressing
15898277|NCT03662997|Device|Hydrocellular Multi-Layer Foam Dressing|Multi-layered, hydrocellular foam dressing with silicone adhesive
15898280|NCT03662971|Drug|Germinal peptide eye drops|Germinal peptide eye drops of 0.0005%, 0.001%, 0.002%, 0.004% and 0.008%
15898281|NCT03662958|Drug|Lutrate|a novel leuprolide acetate 3.75mg depot
15898282|NCT03662958|Drug|Enantone|market reference leuprolide acetate 3.75 mg depot
15898283|NCT03662945|Other|Mobile Geriatric Team intervention|Person-centred intervention based on Comprehensive Geriatric Assessment
15898284|NCT03662932|Other|Early intensive mobilization|"Early mobilization: mobilization with the hospital staff begins already on the day of surgery, and includes mobilization in and out of bed, rise up from a chair, standing and walking.
~Intensive mobilization: mobilization more than 4 times a day in the first postoperative week."
15898285|NCT03662919|Drug|Infliximab|Administered as specified in the treatment arm.
15898286|NCT03662919|Drug|Adalimumab|Administered as specified in the treatment arm.
15898287|NCT03662906|Other|Electroacupuncture|"Bilateral BL32 and BL 33 will be inserted to a depth of 70-95 mm with an angle of 20-30° inward and downward into the second and third sacral foramen. Bilateral BL35 will be inserted to a depth of 60-70 mm with a slightly superolateral direction using needles (0.30 mm in diameter, 75 mm in length). Bilateral BL23 and SP6 will be inserted vertically to a depth of 25-30 mm using needles (0.30 mm in diameter, 40 mm in length). The electric stimulators (6805-D electroacupuncture apparatus, Guangzhou Jiayu Medical Company, China) will connect the bilateral BL32, BL33, BL35 and SP 6 and a continuous wave of 10 Hz frequency and an intensity of 5-10 mA for BL 32 and BL 33 and an intensity of 1-5 mA for SP 6 will be applied.
~The needles will be retained for 60 mins for each treatment session. The participants will be treated three times a week, on alternate days, for 12 successive weeks; 18 sessions for each patient in total."
15898288|NCT03662906|Other|Sham electroacupuncture|"Sham BL 23, BL32 and BL33 which are 2 cm lateral to BL23, BL33 and BL35 will be inserted by the needles (0.20 mm in diameter, 25 mm in length) to a depth of 2-3 mm. Sham SP 6 which is at the midpoint between the spleen meridian and the kidney meridian will be inserted by the needles (0.20 mm in diameter, 25 mm in length) to a depth of 2-3 mm. The electric stimulators (SDZ-V electroacupuncture apparatus, Suzhou Medical Appliance Factory, China) will connect bilateral BL32, BL33, BL35 and SP 6 and a continuous wave of 10 Hz frequency and an intensity of 0.1-0.3mA will be applied.
~The needles will be retained for 60 mins for each treatment session. The participants will be treated three times a week, on alternate days, for 12 successive weeks; 18 sessions for each patient in total."
15898289|NCT03662893|Behavioral|behavioural therapy with written checklist form to complete|Behavioural therapy for overactive bladder such as advice on fluid balance, bladder retraining, urgency suppression or normal voiding techniques, pelvic floor muscle training, caffeine reduction, dietary changes, weight loss and other life style changes
15898290|NCT03662893|Drug|Antimuscarinic drugs used in overactive bladder|Antimuscarinic drugs (Tolterodine, solifenacin, propiverine, darifenacin,fesoterodine)
15898291|NCT03662893|Behavioral|behavioural therapy with written guideline|behavioural therapy with written guideline,which are the same as those in the checklist
15898292|NCT03662880|Radiation|Cardiac Magnetic Resonance|Imaging modality used to detection thrombus in left atrium
15898293|NCT03662880|Radiation|Trans-esophageal echo|a procedure in which the ultrasound probe is inserted into the esophagus and ultrasonographic images are obtained of the heart using echo and color Doppler images.
15898294|NCT03662867|Behavioral|Family-based mindfulness intervention|"For the parent program of family-based mindfulness intervention, the content includes: guide body scan practice; guide stretching exercise and mindful breathing; guide practice of mindfulness to breath and body; teach three-minute breathing exercise; guide joint session and let parents practice mindfulness with children; guide mindfulness practice of exploring difficulties; and teach loving-kindness practice.
~For the child program, the content includes: guide mindful breathing exercise; guide mindful movement exercises; use stories of animal characters to guide body scan exercise; guide mindful eating and mindful walking exercise; tell stories about different emotions and guide discussion; guide the imagination exercise about different emotions; and guide loving-kindness practice."
15898295|NCT03662867|Other|Wait-list|No intervention is given between T1 and T2. Family-based mindfulness intervention would be received after posttest of intervention groups.
15898296|NCT03662854|Biological|Hair Stimulating Complex (HSC)|Patients will receive 2 mL of HSC separated by 6 weeks (total of 4 mL of HSC)
15898297|NCT03662854|Other|Phosphate Buffered Saline|Patients will receive 2 mL of Phosphate Buffered Saline separated by 6 weeks (total of 4 mL of Phosphate Buffered Saline)
15898298|NCT03662841|Procedure|Ablative chemoembolization (ACE)|Ablative chemoembolization (ACE) using Lipiodol-ethanol and anhydrous cisplatin
15898299|NCT03662815|Biological|iNeo-Vac-P01|Neoantigen peptides
15898300|NCT03662815|Other|GM-CSF|immune adjuvant
15898301|NCT03662802|Other|Neural Network Classifier|The convolutional neural network is configured to receive an electrocardiogram segment as an input and to generate an output indicative of whether the received electrocardiogram segment represents a cardiac arrhythmia. No specific features of the electrocardiogram are identified to the convolutional neural network, and the received electrocardiogram segment is not filtered, transformed, or processed prior to reception by the algorithm. The algorithm is trained in a similar manner - the electrocardiogram segments are the sole input to the convolutional neural network.
15898302|NCT03662789|Drug|Iron Isomaltoside 1000|Intravenous infusion
15898303|NCT03662789|Other|Placebo: NaCl 0,9%|Intravenous infusion
15898306|NCT03662763|Drug|Extended-release Guanfacine Hydrochloride (SPD503)|dosing in all subjects will initiate with 1mg/day, and may be increased by 1 mg increments after a minimum of 1 week on the current dose to the maximum doses based on age and weight.
15898307|NCT03662763|Drug|Placebo oral capsule|
15898373|NCT03662399|Other|Standard shoe|Standard shoe
15898308|NCT03662750|Diagnostic Test|Brain Imaging|"The study involves an initial screening visit and 2 study imaging visits at days 15 and 90 after the stroke episode.Patients will undergo:
~Two 90-minute brain imaging sessions using Positron Emission Tomography (PET) (involves injection of safe radiotracers which attach to brain immune cell markers TSPOs and light up the inflamed areas in the brain),
~Two 45-90 minute Magnetic Resonance Imaging (MRI) scanning sessions (include administration of safe chemical contrast agent Gadolinium),
~Physical and neurological examinations (vital signs, assessments of mobility and cognitive functioning),
~Blood testing (routine measurements, blood inflammation markers, and genetic testing for TSPO marker).
~Venous cannula will be inserted into the forearm for the duration of the scans."
15898309|NCT03662737|Diagnostic Test|Visuomotor adaptation task|We will measure performance of the subjects of each group on the visuomotor adaptation task, especially in the rotation condition, in which a perturbation will be induced between the anticipated location of the hand and the provided visual feedback, and in the washout condition, in which the rotation will be removed. We expect that subjects with cannabis use disorder will not show the expected implicit motor adaptation to the perturbation and consequently no deterioration of performance on the task, due to cannabis-induced cerebellar damage. In other words, we want to show that this visuomotor task is a cheap and quick biomarker of cerebellar dysfunction in chronic cannabis users.
15898310|NCT03662724|Drug|Venetoclax|Registry study observing clinical and biological characteristics of patients with acute myeloid leukemia who are treated with Venetoclax.
15898311|NCT03662711|Drug|Bronchodilator Agents|Fluticasone furoate/vilanterol
15898312|NCT03662711|Drug|Bronchodilator Agents|Tiotropium
15898313|NCT03662711|Drug|Bronchodilator Agents|Indacaterol
15898314|NCT03662711|Drug|Bronchodilator Agents|Umeclidinium/vilanterol
15898315|NCT03662711|Drug|Bronchodilator Agents|Fluticasone propionate/salmeterol
15898316|NCT03662711|Drug|Bronchodilator Agents|Beclometasone dipropionate/formoterol
15898317|NCT03662711|Drug|Bronchodilator Agents|Budesonide formoterol
15898318|NCT03662711|Drug|Bronchodilator Agents|Glycopyrronium
15898319|NCT03662711|Drug|Bronchodilator Agents|Aclidinium
15898320|NCT03662711|Drug|Bronchodilator Agents|Umeclidinium
15898321|NCT03662711|Drug|Bronchodilator Agents|Formoterol
15898322|NCT03662711|Drug|Bronchodilator Agents|Indacaterol glycopyrronium
15898323|NCT03662711|Drug|Bronchodilator Agents|Salmeterol
15898324|NCT03662711|Drug|Bronchodilator Agents|Tiotropium olodaterol
15898325|NCT03662711|Drug|Bronchodilator Agents|Aclidinium/formoterol
15898326|NCT03662711|Drug|Bronchodilator Agents|Olodaterol
15898327|NCT03662711|Drug|Bronchodilator Agents|Formoterol/glycopyrronium bromide/beclometasone dipropionate
15898328|NCT03662711|Drug|Bronchodilator Agents|Fluticasone furoate/umeclidinium bromide/vilanterol
15898329|NCT03662698|Behavioral|Guided Imagery|GI is a relaxation technique involving the visualization of images and is considered an adjuvant cancer therapy.The GI intervention will include two hour-long meetings between the participant and a trained interventionist. The sessions will include direct, written, and audio delivery of one of three GI vignettes. The patient will be able to choose one of the three vignettes. The approximately twelve minute long vignettes included in the study will be: Taking a Walk, Healthy Cell Alliance for Treatment, and Daily Intention (32). Patients will also be given access to psychosocial support resources (i.e., clinical psychologists and social workers) at UCCC.
15898330|NCT03662698|Other|Treatment as Usual|This will include a tour of the treatment room and education about RT. Patients will also receive educational materials about RT including the process of RT and CT simulation, treatment side effects, pain management, and swallowing exercises. Participants in this condition will also have access to psychosocial support resources (i.e., clinical psychologists and social workers) at UCCC.
15898331|NCT03662685|Other|Goeckerman Therapy|The Goeckerman regimen consists of exposure to narrowband ultraviolet B (NB-UVB) light phototherapy and application of crude coal tar to the skin 5 days per week. The treatment will occur the UCSF outpatient skin treatment center for approximately 4-5 hours, 5 days a week for 6 weeks (total of 30 sessions). The treatment is consistent with the standard of care Goeckerman treatment protocol at UCSF.
15898332|NCT03662685|Drug|Crude Coal Tar Only|A topical medication consisting of crude coal tar will be applied to the psoriatic skin under plastic wrap occlusion for approximately up to 4-5 hours, 5 days a week for 6 weeks (total of 30 sessions), at the outpatient skin treatment center at UCSF.
15898333|NCT03662685|Device|Phototherapy Only|Light treatment with narrowband ultraviolet B (NB-UVB) phototherapy three days per week for 12 weeks at the UCSF Phototherapy Center per the standard UCSF phototherapy protocol, in which starting dose is based on the subject's Fitzpatrick skin type and gradually increased as tolerated. Each phototherapy treatment will last approximately from under 1 minute to less than 15 minutes.
15898334|NCT03662672|Procedure|Rib raising and lumbar release|Rib raising per protocol described in arm description.
15898335|NCT03662672|Procedure|Sham procedure|Sham procedure per protocol described in arm description
15898341|NCT03662646|Other|no intervention performed- observational only|no intervention performed- observational only
15898342|NCT03662633|Diagnostic Test|Breast cancer group|All the serum samples are collected before any treatments and will be tested in single center in order to decrease bias. Serum SEMA4C levels were measured using a double antibody sandwich ELISA method using in-house SEMA4C detection kits.
15898343|NCT03662633|Diagnostic Test|Benign breast tumor group|All the serum samples are collected before any treatments and will be tested in single center in order to decrease bias. Serum SEMA4C levels were measured using a double antibody sandwich ELISA method using in-house SEMA4C detection kits.
15898344|NCT03662620|Drug|Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg|White colored oval three-layer tablet
15898345|NCT03662620|Drug|Telmisartan 80mg + Amlodipine 5mg + Chlorthalidone 25mg|White and pink colored oval two-layer tablet
15898374|NCT03662386|Procedure|OCT-A|Optical coherence tomography angiography (OCT-A)
15898346|NCT03662607|Behavioral|Virtual reality experience|"Baseline wellness self-assessment administered (reporting on absence or presence and degree of severity of headache, nausea, dizziness, fatigue and vision abnormalities)
~Seated comfortably and free of direct obstruction
~Shown individual components of the VR system (View-Master with smartphone; headphones); given instructions; encouraged to ask questions.
~Begin the VR experience. Study personnel stay in the room & provide guidance and answer questions regarding the technology
~When VR experience concluded, wellness self-assessment will be administered again."
15898347|NCT03662594|Other|ECMO|In this project, the investigators will apply a new technique of atomic layer deposition (ALD) to coat biocompatible and hemocompatible ZrO2/Al2O3 nanolaminate thin films on the inner surface of ECMO tubing to suppress the device-induced coagulopathy. ALD is a thin-film deposition technique for preparing high-quality oxides with atomic-layer accuracy. It offers many benefits including accurate thickness control. These characteristic clear accounts of the high-quality hemocompatible oxide thin films on the whole surface of complex 3-D structures, such as the inner surface The newly-prepared ECMO circuit will then undergo in vitro tests and animal study to carefully examine the safety and effectiveness of improvement of hemocompatibility.
15898348|NCT03662581|Behavioral|Mindfulness Group Program|"The mindfulness program has the following aims (Iacono, 2018): to teach mindfulness skills for stress reduction, self-compassion, and dealing with difficult thoughts and emotions, to promote an integrative concept of health, which treats the whole person, to promote community building and positive relationships, and to capitalize on the power of groups to:
~Foster peer-to-peer learning and support when it comes to coping with life challenges
~Combat isolation
~Increase efficiency, quality, and timeliness of care"
15898349|NCT03662568|Drug|GLS4|Administered GLS4 120 mg orally three times daily in fed state
15898350|NCT03662568|Drug|RTV|Administered RTV 100 mg orally three times daily in fed state
15898351|NCT03662568|Drug|ETV|Administered orally ETV 0.5 mg once daily in fasted state
15898352|NCT03662568|Drug|TDF|Administered TDF 300 mg orally once daily in fasted state
15898353|NCT03662555|Device|Neuromuscular electrical stimulation|"Neuromuscular electrical simulation (NMES) Two self-adhesive electrodes (2 mm thick) will be placed over the rectus femoris, vastus medialis and vastus lateralis muscles. The electrodes will be placed on the motor points of each muscle. The stimulator discharges biphasic rectangular pulses. The stimulation frequency and duty cycle will be 50 Hz and 5 s of stimulation followed by a 5 s pause for each rep. The intensity of electrical flow will be at each subject's maximum that they can tolerate. The stimulation will be for 5 x 5 min sets with 1 min rest between sets.
~Blood flow restriction
~A handheld Doppler probe (Hi-Dop) will detect their auscultatory and visual pulse using the doppler's screen. The cuff will be inflated initially up to their systolic blood pressure and then incrementally by 10 mmHg until no auscultatory or visual pulse is detected. A percentage of 40% or 80% of each subject's LOP will then be used during the BFR conditions."
15898359|NCT03662529|Behavioral|Four-Session Mind Freedom Plan|Problem-solving-focused individualized cognitive behavioral therapy (CBT) that featured homework-worksheets to reinforce session-concepts.
15898360|NCT03662529|Behavioral|Treatment as usual therapy|Therapy was mostly supportive therapy with an emphasis problem solving on increasing veteran motivation. A discussion of the antecedents to relapse would take place if a relapse occurred and coping skills were discussed and reviewed.
15898361|NCT03662516|Drug|PF-04965842|Orally bioavailable small molecule that selectively inhibits JAK 1 by blocking the adenosine triphosphate (ATP) binding site.
15898362|NCT03662516|Drug|Ethinyl estradiol (EE) and levonorgestrel (LN)|Single dose of Oral tablet containing 30 ug EE and 150 ug of LN
15898363|NCT03662490|Device|High resolution oesophageal manometry|High resolution oesophageal manometry (HRM) is the gold standard for the diagnosis of oesophageal motility disorder.
15898364|NCT03662477|Biological|NK cells|"NK cells were generated in good manufacturing practice (GMP) condition. In brief, PBMCs were isolated from 50mL patient's blood with Ficoll-Hypaque(Morecell Biomedical Co. Ltd., Shenzhen, China). Then the Human NK Cell Culture Kit (Cat. No.
~MCF-004, Morecell Biomedical Co. Ltd., Shenzhen, China) and Serum-free Medium for NK Cells (MCM-002, Morecell Biomedical Co. Ltd., Shenzhen, China) was used for induction of NK cells according to the manufacturer's instructions. Three days before NK cell transfusion, the NK cells were sampled and sent to detect the NK cell quality."
15898365|NCT03662464|Other|No intervention|develop and validate a specific tool to score the risk of escaping in Nursing Homes residents
15898366|NCT03662451|Procedure|Robotic assisted hysterectomy|Periumbilical single incision vs multiple abdominal incisions for hysterectomy
15898367|NCT03662438|Other|Home-based physiotherapy program|The home-based physiotherapy program will consist of a total of 2 home visits by a physiotherapist which will be scheduled at the start and midpoint of the 10-week program. The visit will include activity education, goal setting and establishment of a home exercise regimen in patient's own home and community environment). Participants will be contacted weekly via telephone to provide encouragement for patient on the program, enquire about compliance to the exercise program and safety (e.g. falls and healthcare utilisation).
15898368|NCT03662438|Device|Prescription of a Portable Oxygen Concentrator (POC) device|Participants will be prescribed a lightweight Portable Oxygen Concentrator (POC) device [Philips SimplyGo Mini] to be used during exercise and when going into the community setting. Familiarisation and training on the usage of the device will also be provided in conjunction with the home-based physiotherapy program.
15898369|NCT03662425|Drug|Oxytocin|It's a two-week treatment trial.Subjects self-administer intranasal study drug twice daily; before breakfast and before dinner. Each dose consists of six 0.1 ml insufflations (alternating between the left and right nostril) of OT spray containing approximately 24 international units of OT
15898370|NCT03662425|Drug|Saline|It's a two-week treatment trial. Subjects self-administer intranasal study drug twice daily; before breakfast and before dinner. Each dose consists of six 0.1 ml insufflations (alternating between the left and right nostril) of saline spray containing approximately 24 international units of saline
15898403|NCT03662113|Drug|Domperidone|5ml Domperidone prior to VCE
15898375|NCT03662386|Procedure|Visual acuity (ETDRS)|Visual acuity tested with ETDRS score (Early Treatment Diabetic Retinopathy Study)
15898376|NCT03662373|Radiation|carbon ions radiation therapy|Carbon ion radiation therapy to treat adenoid cystic carcinoma, skull base (clivus) chordoma.
15898377|NCT03662373|Radiation|protons radiation therapy|Proton radiation therapy used to treat meningioma and squamocellular rhinopharynx carcinoma
15898378|NCT03662360|Other|essential oils|Following a specific schema, the randomization will be perfomed. Patients enrolled in Group B will receive in environmental diffusion two essential oils, to define their possible effectiveness in the control of the psychological and behavioural disorders
15898379|NCT03662334|Drug|Rapid Acting insulin with pre-treatment of rHuPH20|Hylenex recombinant will be administered via infusion sets and insulin pumps. These will be compatible with component tubing system attached to the insulin infusion site and will be placed in the lower abdominal area.
15898380|NCT03662334|Device|Sham injection|A sham injection will be administered via infusion sets and insulin pumps. These will be compatible with component tubing system attached to the insulin infusion site and will be placed in the lower abdominal area.
15898381|NCT03662308|Device|Heated Vest|Heated vest that regulates its heat output based on the user's skin, the user's core temperature, and the ambient temperature
15898382|NCT03662308|Device|Non-Heated Vest|A similarly insulated (compared to the experimental vest), but non-heated vest
15898383|NCT03662295|Behavioral|Language treatment|Individual speech-language therapy sessions totaling 1.5 to 2.5 hours five days per week. Intervention activities include performing oral and written confrontation and responsive naming, writing single words to dictation, reading single words and sentences aloud, and generating written and spoken picture descriptions.
15898384|NCT03662282|Drug|Omegaven|Omegaven® fat emulsion will be used as a compassionate use treatment for critically ill infants with parenteral nutrition associated liver injury
15898385|NCT03662269|Drug|indomethacin|indomethacin (75mg, bid, po, 14days)
15898386|NCT03662269|Drug|Placebo|placebo (75mg, bid, po, 14days)
15898387|NCT03662269|Drug|Omeprazole|placebo (20mg, qd, po, 14days)
15898388|NCT03662256|Other|Current Primary Care Referral Process|Children who refer hearing screening will receive the same referral method each preschool had been using previously. This process involves a letter home to the parents, either sent with the child or by mail, requesting that the parent/caregiver bring the child to village health clinic for an evaluation.
15898389|NCT03662256|Other|Telemedicine Referral Process|In communities randomized to the expedited telemedicine intervention, parents of children who refer hearing screening will receive a phone call from the school or the clinic on the day of screening notifying them of the day and time of their child's telemedicine consultation appointment. Appointments will be made with community health aides (CHAs) who have dedicated time blocked off to perform telemedicine consults. Participating children who refer screening will be transported to clinic for their appointment with adult chaperones. Parent participation will be required unless parents direct otherwise. Nonparticipating children in communities assigned to the expedited telemedicine intervention arm will receive standard referral following the current school primary care referral process.
15898390|NCT03662243|Behavioral|Multicomponent reading and writing treatment|Intervention procedures incorporated into the program include drilling on sight words to improve immediate recognition of common words; engaging in Multiple Oral Reading procedures to increase reading fluency; practicing oral spelling of sight words to improve spelling accuracy; generating written sentences to improve accurate spelling and use of written conventions (e.g., punctuation, capitalization); and summarizing and subsequently writing sentences about read material to establish strategies to enhance reading comprehension and promote written expression.
15898391|NCT03662217|Other|Algorithm-based diet|Personalized nutrition plan based on an algorithm for predicting the personalized glucose response to food. The algorithm's predictions are based on many personal measurements, including blood tests, personal lifestyle and gut bacteria
15898392|NCT03662217|Other|ADA- based diet|The American standard of care dietary guidelines for diabetes.
15898393|NCT03662204|Other|Blood Sample Collection|Subjects participating in the study will have blood drawn at enrollment.
15898394|NCT03662191|Drug|Tafamidis|bioavailability study
15898395|NCT03662165|Behavioral|Intervention|"A text was sent three times, one week apart, first in Kiswahili, then in English and then again in Kiswahili, and read: You can now self-test at home or in the clinic for HIV using a new test kit available from all North Star Alliance clinics in Kenya. Your health, our priority. Participants who came to any North Star clinic in Kenya in the intervention arm were given a demonstration of the self-testing kit and then offered a choice among (1) the standard provider-administered blood-based HIV test; (2) the self-administered oral HIV test for use in the clinic with provider supervision; or (3) the self-administered oral HIV test kit for home use with phone-based post-test counseling."
15898396|NCT03662165|Behavioral|Enhanced Standard of Care|"Those randomized to the enhanced Standard of Care (SOC) arm received the SOC message reminding clients about HIV testing sent three times, one week apart first in Kiswahili, then in English and then again in Kiswahili. The message read: North Star Alliance East Africa would wish to kindly remind you to visit any of our roadside wellness centres for HIV testing. Your health, our priority. Participants who came to any North Star clinic in the enhanced SOC arm only offered the standard provider-administered blood-based HIV test."
15898397|NCT03662165|Behavioral|Traditional Standard of Care|"Those randomized to the traditional Standard of Care (SOC) arm received the SOC message reminding clients about HIV testing sent one time in both Kiswahili, then in English and Kiswahili simultaneously. The message read: North Star Alliance East Africa would wish to kindly remind you to visit any of our roadside wellness centres for HIV testing. Your health, our priority. Participants who came to any North Star clinic in the traditional SOC arm only offered the standard provider-administered blood-based HIV test."
15898398|NCT03662152|Device|Foam roller|Foam roller massage after DOMS
15898399|NCT03662152|Device|Vibration foam roller|Foam roller massage with vibration after DOMS
15898400|NCT03662139|Other|Dynamic Gait Index|Dynamic Gait Index is a clinical tool for assessing functional balance and gait variability in people with neurologic conditions
15898401|NCT03662126|Drug|KRT-232|KRT-232, administered by mouth
15898402|NCT03662126|Drug|Best Available Therapy (BAT)|"Best available therapy options include:
~hydroxyurea
~chemotherapy or
~supportive care (including but not limited to corticosteroids and androgens; JAK inhibitors not allowed)."
15898408|NCT03662100|Device|Prefilled syringe (PFS)|PFS to administer LY3074828
15898409|NCT03662087|Combination Product|HMA+DLI|HMA: Decitabine was administered at 20mg/m2/day for five consecutive days or Ara-C was administered at 75mg/m2/day for seven consecutive days. DLI was administered at a median dose of 1.0 (range 0.7-1.4) ×10*8 mononuclear cells/kg.
15898410|NCT03662087|Biological|DLI|DLI was administered at a median dose of 1.0 (range 0.7-1.4) ×10*8 mononuclear cells/kg.
15898411|NCT03662074|Drug|Gemcitabine|Given IV
15898412|NCT03662074|Biological|Nivolumab|Given IV
15898413|NCT03662061|Other|Assessment of the follow-up of oncological and geriatric recommendations 4 months after the RCP|"After inclusion, patient's results are discussed at a weekly onco-geriatric multidisciplinary team meeting including surgeons, geriatrics, oncologists, radiotherapist, nurse, pharmacist. Oncological and geriatric recommendations are given.
~A phone call is made to the patient to evaluate the follow-up of the oncological and geriatric recommendations defined during the RCP along with their survival, autonomy and quality of life."
15898414|NCT03662048|Behavioral|Safe|Feedback, according to the 2016 national American Academy of Pediatrics (AAP) guidelines on Sudden Unexplained Infant Death (SUID) risk factors, will be generated by the study team and communicated with parents. Feedback will be given to parents in the intervention group at ages 1 and 2 months. The control group parents will only receive this feedback at age 2 months.
15898415|NCT03662035|Drug|Apatinib|"Apatinib
~Patients with advanced pancreatic cancer after failure of first-line chemotherapy will receive Apatinib (500mg/d, orally) 30 minutes after meal with warm water.Take 21 days as a cycle, patients will receive this treatment until they have got disease progressed. Dose adjustment: with 3/4 level of adverse reactions, the dose should be lowered to 250 mg/d."
15898416|NCT03662035|Drug|S-1|"S-1
~Patients will receive S-1 (60mg/d for BSA<1.25m2, 80mg/d for 1.25<BSA<1.5m2, and 100mg for BSA >1.5m2, orally) twice a day, once after breakfast and once after dinner, for 14 days, 7 days for suspension and 21 days as one cycle."
15898417|NCT03662022|Drug|Rifampicin|Rifampicin will be given in the same way to arms 2, 3 and 4 (weight dependent). Only the strategy of whom to offer PEP differs between the arms.
15898418|NCT03662009|Other|multilimb dual task|control of arm and foot in two attentional contexts of simulated driving
15898419|NCT03661996|Drug|CNTX-4975-05|Osteoarthritis (OA) intra-articular injection 1 mg CNTX-4975-05
15898420|NCT03661996|Drug|Lidocaine without epinephrine|15 mL lidocaine intra-articular injection
15898421|NCT03661996|Device|ElastoGel|Cooling Device
15898422|NCT03661996|Device|Breg Ice Water Pump|Cooling Device
15898423|NCT03661983|Drug|Aripiprazole|Participants received aripiprazole tablets, orally as per the regimen specified in the arm description.
15898424|NCT03661983|Drug|Placebo|Participants received aripiprazole matching-placebo tablets, orally as per the regimen specified in the arm description.
15898425|NCT03661970|Other|Cognate Speech Synthesizer sound percepts|The cognate speech synthesizer will generate an acoustic output, as well as a visual display of the acoustic signals. The outputs on the monitor and the synthesizer will be recorded.
15898426|NCT03661957|Procedure|Non grafted maxillary sinus floor elevation with simultaneous implant placement|lateral window for sinus elevation ,membrane elevation ,implant placement , membrane for window closure
15898427|NCT03661957|Procedure|using short dental implants for posterior atrophic maxilla|placement of short dental implant with bone height below 8mm
15898428|NCT03661944|Diagnostic Test|functional performance test|Functional performance test is to test the ability of the athletes in functional movements
15898429|NCT03661931|Diagnostic Test|DQPN Validation|We are planning to recruit 150 individuals who are patients in the Boston Heart Lifestyle Program and are already having fatty acids measured as part of clinical care, and ask them to complete the DQPN, FFQ, and a brief User Experience Questionnaire for each dietary assessment method.
15898430|NCT03661918|Behavioral|In-Person First Session|Conduct first session in person vs. over the phone
15898431|NCT03661918|Behavioral|Second Caregiver|Have second caregiver participate in three coaching calls
15898432|NCT03661918|Behavioral|WiFi-enabled Scale|Have participant weigh in weekly on a wifi-enabled scaled vs. regular scale
15898433|NCT03661918|Behavioral|10 Core Coaching Calls Only|Participant will receive 10 core phone coaching sessions
15898434|NCT03661905|Other|Cognitive therapy|Empirically-supported psychological intervention for various mental health concerns including obsessive-compulsive disorder (OCD). Twelve treatment sessions include components to foster cognitive (i.e. thinking) and behavioural changes.
15898435|NCT03661905|Behavioral|Exposure and Response Prevention|Exposure therapy in which individuals confront their fears and discontinue their escape response. Twelve treatment sessions implementing exposure which is prolonged and repeated, requiring clients/patients to engage in a series of exposures to feared stimuli (e.g., contaminants, doubts, intrusive thoughts), and to refrain from engaging in compulsive behaviour until their anxiety subsides.
15898436|NCT03661892|Drug|Syndros|"As noted in arm description. For patients who have side effects secondary to Sydnros, the dose will be decreased as below:
~Dose subject is taking Reduction recommendation 8.4mg BID Decreased to 8.4mg AM , 4.2mg PM (or it can be 4.2g in AM and 8.4mg in PM- depending on their side effect timing) 8.4mg AM, 4.2mg PM (or vice versa) 4.2mg BID 4.2mg BID 4.2mg once a day 4.2mg once a day Stop and take off study"
15898437|NCT03661879|Drug|NNC9204-1706|Participants will receive NNC9204-1706 subcutaneous (s.c., under the skin) injection(s) once daily (OD) for 10 weeks. They will either receive the same dose throughout the trial, or the dose will be escalated over a period of 1-3 weeks and continued for at least 7 weeks at the same dose.
15898438|NCT03661879|Drug|Placebo (NNC9204-1706)|Participants will receive matching placebo (NNC9204-1706) s.c., injection(s) OD for 10 weeks.
15898439|NCT03661853|Behavioral|Control|60 minute psycho-education on alcohol and drugs.
15898440|NCT03661853|Behavioral|Functional Analysis|"Component of standard CBT that helps to break the chain of events (external and internal) that lead from cue (trigger) to alcohol use to consequences of use."
15898441|NCT03661853|Behavioral|Cognitive Restructuring|CR is used to to help identify and change automatic, habituated thoughts that occur in response to alcohol triggers.
15898442|NCT03661853|Behavioral|Dealing With Cravings|DC is used reduce cravings for alcohol by conjuring negative images associated with alcohol, teaching distraction techniques, and teaching breathing techniques to reduce physiological arousal.
15918500|NCT03509012|Drug|Etoposide (dose level 1)|IV
15898443|NCT03661840|Behavioral|Acceptance and Commitment Therapy|Intervention group participants will attend eight weekly, 90-minute, in person, group-based ACT sessions. Groups will be initiated with no more than 10 participants and no fewer than 6 participants. Sessions will include key theoretical ACT constructs and strategies as they relate to chronic pain. A licensed clinical psychologist or licensed clinical social worker trained in ACT will facilitate all sessions. Participants in the ACT intervention group will also continue to receive medication management and other behavioral management interventions that they would get as usual treatment.
15898444|NCT03661840|Other|Treatment as Usual|Treatment as usual will include ongoing provision of usual treatment options for pain management. This includes continued medication management for cancer related chronic pain by prescribing providers, and access to supportive oncology services. It may also include other behavioral pain management such as physical therapy, acupuncture, or massage.
15898445|NCT03661827|Diagnostic Test|Stress Cardiac MRI|Dobutamine and adenosine stress MRI
15898446|NCT03661814|Device|Prevena|The NPWT device is a wound dressing with a vacuum system that can be placed over abdominal wounds, placed in the immediate postoperative period over abdominal wounds after clean/contaminated colorectal surgical procedures.
15898447|NCT03661788|Drug|Atomoxetine|14-day treatment interval: first week 40 mg atomoxetine (one pill), second week 80mg atomoxetine (two pills)
15898448|NCT03661788|Drug|Placebos|14-day treatment interval: first week one placebo pill, second week two placebo pills
15898449|NCT03661775|Drug|Magnesium sulfate administration|controlled group : administration of magnesium sulfate is 4 grams for loading dose in 15 minutes, followed by 2 grams for maintenance dose per hour Experimental group : administration of magnesium sulfate is 4 grams for loading dose in 15 minutes, followed by 2.5 grams for maintenance dose per hour
15898450|NCT03661762|Device|CAVA|prototype device for monitoring dizziness
15898451|NCT03661749|Other|clean catch|clean catch technique applied to collect urine for PR/CR ratio
15898452|NCT03661736|Other|Food for Specific Medical Purpose|Infants aged 1 to 8 months with moderate-to-severe cow's milk allergy fed an amino acid-based formula with two added human milk oligosaccharides
15898453|NCT03661723|Drug|Pembrolizumab|Pembrolizumab is a drug (an antibody) that may treat cancer by working with the immune system
15898454|NCT03661723|Drug|Bevacizumab|"Bevacizumab (also known as Avastin) is designed to prevent or slow down the growth of cancer cells by blocking the growth of blood vessels."
15898455|NCT03661723|Radiation|Re-irradiation|Radiotherapy destroys cancer cells using radiation aimed at a cancer from a machine
15898456|NCT03661710|Other|Investigating Adherence to Standard of Care Medication and Cardiac Rehabilitation|Information from health care insurance providers on how many patients adhered to prescribed medication and how many underwent cardiac rehabilitation and how adherence influenced cardiovascular outcome will be retrieved
15898457|NCT03661697|Device|Laser Therapy|"Clear and Brilliant Permea is a 1927nm fractional laser with 3 settings; low, medium, high.
~All interventions were done at low with four passes to each participant's full face."
15898458|NCT03661697|Other|Basic Skin Care Regimen|Skin Medica brand cleanser, sunscreen, moisturizer as directed for 12 weeks
15898459|NCT03661697|Other|Lytera|cosmeceutical serum applied to face daily for 12 weeks
15898460|NCT03661684|Drug|Prednisone|40 mg po q day of Prednisone for 3 days
15898461|NCT03661671|Diagnostic Test|LCI+white light|Firstly use white light to observe from cardia to duodenum and then switch LCI model to observe from antrum to cardia
15898462|NCT03661658|Procedure|Using short dental implant|Using short dental implant for patients with atrophic posterior mandible.
15898463|NCT03661658|Procedure|Inferior alveolar nerve lateralization with simultaneous implant placement|Inferior alveolar nerve lateralization with simultaneous implant placement in atrophic posterior mandible.
15898464|NCT03661645|Drug|10 mg IV dexamethasone & 6 day oral methylprednisolone taper|"Drug: 6-day oral methylprednisolone (glucocorticoid) taper course The oral methylprednisolone taper course will begin on the day of surgery and will include 24mg on day 1, 20mg on day 2, 16mg on day 3, 12mg on day 4, 8mg on day 5, and 4mg on day.
~Drug:10 mg intravenous (IV) dexamethasone"
15898465|NCT03661645|Other|10 mg IV dexamethasone|Drug:10 mg intravenous (IV) dexamethasone
15898466|NCT03661632|Drug|BMS-986310|Specified dose on specified days
15898467|NCT03661632|Biological|Nivolumab|Specified dose on specified days
15898468|NCT03661619|Procedure|Sub-epithelial connective tissue graft harvested from the palatal for root coverage procedure|Envelope technique + sub-epithelial connective tissue graft harvested from the palatal for root coverage procedure
15898469|NCT03661619|Procedure|Sub-epithelial connective tissue graft harvested from the tuberosity for root coverage procedure|Envelope technique + sub-epithelial connective tissue graft harvested from the tuberosity for root coverage procedure
15898470|NCT03661606|Other|Simulated Altitude Chamber|"Subjects will wear one armband linked biosensor: the Everion® CD, to capture their HR, RR and activity levels, continuously for 4 days.
~Measurements will be taken at sea level (baseline), during controlled rest and normal day-to-day activities without exercise for the first 3 days to establish an individual's physiological baseline. On Day 4 subjects will be monitored for another period of controlled rest followed by 2 hours in a simulated altitude (intervention) chamber with altitude change of 3000 meters. At the chamber site, subject will rest quietly for 1 hour outside the chamber prior to entering the chamber for 2 hours. In the chamber, subjects will be asked to remain seated. At the completion of the chamber run, subjects will hand back the device and smartphone and complete a user experience survey. A follow up phone call to check on subjects will then be done on day 5 before closing the study."
15898471|NCT03661593|Other|Cataract guideline|The patients gets an IOL according to cataract guideline correcting the ametropia
15898472|NCT03661580|Behavioral|Behavioural Activation|The BA intervention will be the outpatient version of the Life Enhancement Treatment for Substance Use (LETS ACT; Daughters et al., 2008). This brief, manualised BA intervention has been specifically developed to meet the needs of patients with comorbid substance misuse and depression in drugs and alcohol treatment settings. LETS ACT targets the link between mood, substance use and behaviour, and focuses on identifying and increasing rewarding, substance-free activities that are based on the patient's own personal values.
15898553|NCT03660917|Drug|Riluzole|Study drug will be orally dispensed in doses of 50 mg twice daily for 12 months in the treated group.
15898886|NCT03658369|Dietary Supplement|Methyl crystalline cellulose|2 Capsules
15898473|NCT03661580|Behavioral|Treatment as Usual|The control intervention in this study is Treatment as Usual at the CDAT service. Treatment as Usual consists of planned key-working sessions every 2-4 weeks with an allocated caseworker plus monthly prescribing review appointments with a medical practitioner for patients who require drug treatment medication. Key-working sessions are primarily focused on addressing substance misuse issues using a range of intervention techniques such as motivational interviewing and brief solution-focused therapy.
15898474|NCT03661567|Radiation|chest radiation|split-course chest radiation
15898475|NCT03661567|Drug|concurrent chemotherapy|weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with chest radiation
15898476|NCT03661567|Drug|Methylprednisolone|Methylprednisolone after the first course of radiation, once a day, 32 milligram (mg) for 7 days, 24 mg for the next 7 days, then 16mg for 7 days, and 8 mg for the last 7 days.
15898477|NCT03661554|Biological|BCMA CAR-T Cells|The Chinese name of CAR-T cells is chimeric antigen receptor T cells. It is through gene transfection technology, so that patients with T lymphocytes can carry B cell-specific antigens, so that T lymphocytes can selectively kill B lymphocyte-derived tumor cells.
15898478|NCT03661541|Drug|Squaric Acid Dibutyl Ester|2% squaric acid dibutyl ester (SADBE) (Supplied by Squarex) is topically applied to the inner aspect of the upper arm of the subject and covered with Tegaderm. Subject is advised to wash it off after 3 hours.
15898479|NCT03661528|Drug|andexanet alfa|Andexanet is a recombinant version of human FXa
15898480|NCT03661528|Drug|Placebo|Placebo to be administered alongside usual care
15898481|NCT03661515|Drug|Selinexor|"According to escalation level:
~Level -1: Selinexor 40 mg/day, once weekly
~Level 1: Selinexor 60 mg/day, once weekly
~Level 2: Selinexor 80 mg/day, once weekly
~Level 3: Selinexor 100 mg/day, once weekly"
15898482|NCT03661515|Drug|fludarabine|fludarabine 30 mg/m2/day intravenously on days 1 to 4
15898483|NCT03661515|Drug|idarubicin|idarubicin 10 mg/m2/day intravenously on days 1 to 3
15898484|NCT03661515|Drug|cytarabine|cytarabine 2 g/m2/day intravenously on days 1 to 4
15898485|NCT03661515|Drug|G-CSF|G-CSF 300 mcg/m2/day subcutaneously from days -1 to 5
15898486|NCT03661502|Device|VVV|ventilation mode with variable tidal volume is chosen. the average tidal volume is 6 ml/kg and respiratory rate adapted to reach end tidal con between 30 and 50 mmHg
15898487|NCT03661502|Device|PCV|ventilation mode with constant tidal volume is chosen. the tidal volume is 6 ml/kg and respiratory rate adapted to reach end tidal con between 30 and 50 mmHg
15898488|NCT03661489|Drug|Remimazolam|For induction and maintenance of general anesthesia
15898489|NCT03661489|Drug|Propofol|For induction and maintenance of general anesthesia
15898490|NCT03661476|Behavioral|Oculo-Motor Exercises (OME)|"Oculomotor Exercises (OME); The saccadic eye movement exercise included moving the eyes horizontally between two stationary targets while keeping the head still.
~The smooth pursuit exercise included moving the target horizontally and tracking it with the eyes while keeping the head still.
~The adaptation X1 exercise included moving the head horizontally while keeping the stationary target in focus.
~The adaptation X2 exercise included moving the head and target in opposite directions horizontally while tracking the target with the eyes."
15898491|NCT03661463|Drug|Aspirin|Drug
15898492|NCT03661450|Diagnostic Test|Clinical Decision-Support System|Patient Data is evaluated by a Clinical Decision-Support System searching for age-adapted pediatric SIRS-criteria, aiming for a high sensitivity and specificity
15898493|NCT03661437|Device|Actigraph|Wear Actiwatch
15898494|NCT03661437|Other|Questionnaire Administration|Ancillary studies
15898495|NCT03661437|Procedure|Systematic Light Exposure|Undergo BWL treatment
15898496|NCT03661437|Procedure|Systematic Light Exposure|Receive DWL treatment
15898497|NCT03661424|Drug|HER2 BATs|A test dose (1 million cells) of HER2 BATs (at one of the two dose levels: 5 million cells or 10 million cells per infusion) followed by 8 weekly infusions of Her2 BATs delivered into the ventricle of the brain. Infusions are delivered weekly over 8 weeks with brain MRIs prior to first infusion and following the eighth infusion. Blood will be drawn for immune evaluation before during and after study treatment.
15898498|NCT03661411|Drug|Aspirin|100mg qd
15898499|NCT03661411|Drug|Clopidogrel 75mg|75mg（after first dose of 300mg）qd
15898500|NCT03661411|Drug|Alteplase|Iv at 0.9 milligrams per kilogram (mg/kg)
15898501|NCT03661398|Device|Transcatheter Mitral Valve Replacement|All eligible patients will be in the treatment arm for treatment with the Caisson Transcatheter Mitral Valve Replacement (TMVR) System. There is no control (comparator) arm for this study.
15898502|NCT03661385|Drug|Nitric Oxide|Addition of nitric oxide 20ppm into bypass circuit
15898503|NCT03661372|Other|Robot|Use of a telesimulation robot using contextual interview format.
15898504|NCT03661372|Other|Face-to-face|Use of face-to-face patient interview using contextual interview format.
15898505|NCT03661359|Other|Social Determinants of Health Referrals|Patients who screen positive for any of the Social Determinants of Health will be given information for referral to any of the community resources that apply to their situation.
15898506|NCT03661346|Drug|Labetalol|"Aliquots of 20mg of Labetol
~• Maximum Dose - 300mg total for case"
15898507|NCT03661346|Drug|Esmolol|"Infusion - 0.1mg/kg/min
~• Maximum Dose - after 30 minutes, 0.3mg/kg/min"
15898508|NCT03661333|Behavioral|Dialectical behavioral therapy|DBT will be conducted over 1 year, and divided into two modalities: skills training, conducted in 60 minute biweekly family meetings and individual therapy conducted in 60 minute biweekly sessions. Family skills training proceeds as follows: psychoeducation about DBT and bipolar disorder, mindfulness skills, emotion regulation skills, distress tolerance skills, interpersonal skills, and walking the middle path skills. Individual therapy sessions aim to aid the adolescent in applying skills in their daily lives. We adopt the standard DBT hierarchy of treatment targets, whereby the individual therapist selects behaviors to focus on based on the following priorities: 1) decreasing life-threatening behaviors, 2) decreasing therapy-interfering behaviors, 3) decreasing quality-of-life interfering behaviors, and 4) increasing behavioral skills. Therapists will be available to participants and their participating family members by cell phone for in-vivo skills coaching between sessions.
15898509|NCT03661320|Biological|Nivolumab|Specified dose on specified day
15898510|NCT03661320|Drug|BMS-986205|Specified dose on specified day
15898511|NCT03661320|Drug|Gemcitabine|Specified dose on specified day
15898518|NCT03661281|Diagnostic Test|Jebsen Taylor Hand function test|consists of seven test items, which are felt to represent various hand activities. These test items include: writing a short sentence; turning over 365 inch cards; picking up small objects and placing in a container; stacking checkers; simulated eating; moving empty large cans; and moving weighted large cans.
15898519|NCT03661281|Diagnostic Test|Pinch strength|Measured in every splint position using a standard dynamometer
15898520|NCT03661281|Diagnostic Test|Grooved pegboard test|Time will be measured and compared between control, MP splint and IP splint
15898521|NCT03661268|Other|fluid chanllenge|A bag of 500ml of normal saline is infused within 15 minutes using a bag pressurized to 300 mmHg.
15898522|NCT03661255|Behavioral|PC CARES|PC CARES trains local residents to deliver the PC CARES curriculum in their own community. These facilitators will attend a 40 hour training, and then will deliver the 4 session PC CARES curriculum in their home village. To aid local facilitators, each session follows the same structure after a beginning ritual:(1) agreements/safe talk, (2)'small wins', (3)'what do we know?' (facilitator shares current research on suicide prevention or wellness) (4)'what do we think?' (participants have an opportunity to discuss their thoughts on the research presented), and (5)'what we want to do?' (participants identify what steps they can take in their village to make positive change).The content of learning circles (LCs) includes community-level conditions, evidence-based approaches, risk and protective factors that can prevent suicide and promote well-being.Each LC includes both primary and secondary prevention strategies.Teaching tools include charts, short films, and case studies.
15898523|NCT03661242|Behavioral|Physical activity|Patients in shared care arm has regular combined visits with Oncologist and Clincal Exercise Physiologist (CEP). Individual physical activity plan developed by CEP for patients in shared care arm.
15898524|NCT03661229|Device|CVInsight Monitoring|All participants (n=50) will receive CVInsight non-contact device and CVInsight contact device application during two of their regularly scheduled dialysis sessions.
15898525|NCT03661216|Dietary Supplement|Nephure Oxalate-reducing Enzyme|3g of Nephure is mixed with 8oz of water and ingested with breakfast, lunch and dinner.
15898526|NCT03661216|Other|Placebo|3g of non-GMO maltodextrin is mixed with 8oz of water and ingested with breakfast, lunch and dinner.
15898527|NCT03661203|Behavioral|Focus group|Focus group for qualitative group only
15898528|NCT03661203|Behavioral|Individual interview|Individual interview for qualitative group only
15898529|NCT03661203|Behavioral|online self questionnaire|online self questionnaire
15898530|NCT03661203|Behavioral|self questionnaire|online self questionnaire following focus group or individual interview For qualitative group only
15898531|NCT03661190|Other|Grammatical Reasoning|START measures the ability to determine the relationships among different shape combinations which are assigned to grammatical statements about them which can be either correct or incorrect. It is a measure of attention, working memory and executive control.
15898532|NCT03661190|Other|Card Pairs|A basic picture-matching task.
15898533|NCT03661177|Other|Sovereign nation diet|We will pilot a RCT with delayed intervention to provisionally assess health impacts of consuming a diet that is 50% indigenous foods for four weeks.
15898534|NCT03661164|Procedure|corneal cross linking|Iontophoretic corneal cross linking
15898535|NCT03661138|Drug|Upadacitinib|Upadacitinib is administered orally.
15898536|NCT03661138|Drug|Placebo for upadacitinib|Placebo is administered orally.
15898537|NCT03661138|Drug|Topical Corticosteroids (TCS)|It is administered concomitantly with upadacitinib or placebo.
15898538|NCT03661125|Drug|Saracatinib|AZD0530 (Saracatinib) 50 mg Tablet Pink Round 7.0 mm ADM P/5406/49. Two tablets to be taken every morning for 14 days.
15898539|NCT03661125|Drug|Placebo Oral Tablet|Placebo AZD0530 (Saracatinib) 50 mg Tablet Pink Round 7.0 mm ADM P/5406/37. Two tablets to be taken every morning for 14 days.
15898540|NCT03661099|Diagnostic Test|colonoscopy|endoscopists' performance outcome
15898541|NCT03661086|Device|O2matic|O2matic controls oxygen with the aim of maintaining SpO2 within a predefined target interval, e.g. 88-92 % with the lowest possible supplementation of oxygen by nasal cannula
15898542|NCT03661073|Behavioral|Assessment of motor imagery ability|The intervention will last 3 hours ± 45 minutes, the assessment will be spread over 3 sessions of 1 hour ± 15 minutes on one week. The time between two sessions will depend on patient fatigability and availability. The VMIQ-2 and the KVIQ-20 will be realized during the first session. In the second session, patients will perform the hand laterality judgment task and the MIQ-RS. During the last session the Timed up and go and the box and block test will be realized.
15898543|NCT03661073|Behavioral|Assessment of motor imagery ability of healthy subject|The intervention will last 2 hours ± 15 minutes. All the tests will be spread over 1 session. Assessment order will be VMIQ-2, KVIQ-20, the hand laterality judgment task, the after a break MIQ-RS, iTUG and iBBT.
15898544|NCT03661047|Drug|AMR101 (VASCEPA, icosapent ethyl)|Oral administration, 4 grams per day
15898545|NCT03661034|Device|GammaSense Stimulation System (non-invasive, non-significant risk)|Non-invasive, non-significant risk audio-visual sensory stimulation device
15898546|NCT03660995|Behavioral|Evaluation of language skills and procedural learning of children with SLI and their controls. DNA sampling.|"Behavioral evaluation of language skills at the formal, semantic and pragmatic levels and of procedural learning for each child with SLI and each control child.
~DNA sampling for each child."
15898547|NCT03660956|Behavioral|Exercise|Twelves-week exercise training sessions include a variety of strength, flexibility, and coordination exercises. Each exercise session lasts for one hour. Participants are expected to attend exercise session once a week and are encouraged to continue exercising at home.
15898548|NCT03660956|Behavioral|Back counselling|Procedure of back counselling includes one session back counselling, lasting one hour. The topics of back counselling session are as follows: (1) Anatomy of lumbar; (2) Factors causing low back pain; (3) Problems of physical inactivity for the lumbar; (4) Risk of poor postures for developing persistent/chronic low back pain; (5) Maintaining right posture of the lumbar; (6) Avoiding harmful loading of the back during work and leisure time.
15898549|NCT03660943|Drug|Placebo|Receiving Placebo Injection
15898550|NCT03660943|Drug|CNTX-4975-05 (trans-capsaicin)|Receiving CNTX-4975-05 Injection
15898551|NCT03660930|Drug|Nanoparticle Albumin-Bound Rapamycin|Given IV
15898552|NCT03660930|Drug|Pazopanib hydrochloride|Given PO
15918501|NCT03509012|Drug|Etoposide (dose level 2)|IV
15898554|NCT03660917|Drug|Placebo|Placebo drug for 6 months, however they will receive riluzole during the last 6 months of study, so that all patients will undergo the active drug in the last phase of the study.
15898555|NCT03660904|Biological|home made vitrification & thawing kit|home made vitrification was made and prepared for vitrification of blastocysts then thawing with a prepared thawed media too
15898556|NCT03660904|Biological|commercially made vitrification & thawing kit|commercially available vitrification & thawing kit were made and prepared for vitrification of blastocysts then thawing with a prepared thawed media too
15898557|NCT03660891|Diagnostic Test|measuring neuromuscular block|During anesthesia patients are monitored with two instead of one NMT monitor. the difference in measured TOF-PTC is compared
15898558|NCT03660878|Drug|Reproxalap Ophthalmic Solution (0.25%)|Reproxalap Ophthalmic Solution (0.25%) administered four times a day and an additional four times a day on an as needed basis.
15898559|NCT03660878|Drug|Reproxalap Ophthalmic Solution (0.5%)|Reproxalap Ophthalmic Solution (0.5%) administered four times a day and an additional four times a day on an as needed basis.
15898560|NCT03660878|Drug|Vehicle Ophthalmic Solution|Vehicle Ophthalmic Solution administered four times a day and an additional four times a day on an as needed basis.
15898561|NCT03660865|Device|Light Adjustable lens (LAL) and Light Delivery Device (LDD)|Primary eye will receive Light adjustable lens with Light delivery Device treatments
15898562|NCT03660865|Device|Control monofocal IOL|Fellow eye will receive control monofocal IOL
15898563|NCT03660839|Drug|Artefenomel (OZ439)|Pharmaceutical form: Granules for oral suspension Route of administration: Oral
15898564|NCT03660839|Drug|Ferroquine (SSR97193)|Pharmaceutical form: Capsule Route of administration: Oral
15898570|NCT03660813|Diagnostic Test|Follicle measurment|Follicle will be measured before aspiration
15898571|NCT03660813|Drug|Ovitrelle ( Hcg 250 mcg)|Drug used for triggering
15898572|NCT03660813|Drug|Decapeptyl ( GnRH Agonist 0.1 mg*2 )|Drug used for triggering
15898573|NCT03660800|Drug|CTAP101 Capsules|Calcifediol Extended-Release Capsules
15898574|NCT03660787|Drug|Seroguard|Seroguard 0.41 g/L solution
15898575|NCT03660787|Drug|Placebo|Saline
15898576|NCT03660774|Other|No treatment given|The participants will undergo a brief physical examination focused on neurologic function (muscle function, sensation, coordination, walking). Parents will be asked by the study team or the psychologist about their children and will complete several commonly used standard surveys about brain development, thinking, behavior, and decision making. The participants will also engage with the psychologist to evaluate development or thinking (IQ), and depending on their age they may be asked to complete one or more commonly used standard surveys about behavior and decision making.
15898577|NCT03660761|Drug|apatinib|The patient was given a daily dose of apatinib 500mg (or based on weight). For adult, the dose of apatinib was prescribed with 425 mg or 500 mg per day and four weeks for a cycle. The dosage was modified to 250 mg if patients experienced ≧grade 2 hematologic adverse events, hand and foot syndrome, proteinuria, fecal ocular blood, or grade 3/4 hypertension, or other grade 3/4 adverse events. Apatinib was administrated until disease progression, unacceptable toxicity or death.
15898578|NCT03660761|Drug|temodar|dose-dense temozolomide (100 mg/m2 , 7 days on with 7 days off ) , 28d
15898579|NCT03660748|Biological|MET-2|Ingestion of a novel human microbiome preparation
15898580|NCT03660722|Other|blood and urinary samples|blood samples, rectal and urethral swabs , urine samples at inclusion, after 4 weeks then 12 weeks
15898581|NCT03660709|Behavioral|Intervention|"Standard-of-care HIV testing and counseling
~Watch a video clip while waiting for the HIV testing result on a tablet.
~Receive a pamphlet and post-test counselling promoting HIV retesting.
~Receive the e-health HIV risk calculator through e-mail, SMS or social media means 3 and 5 months afterwards.
~Receive brief e-health reminder for retesting at Month 3 and 5."
15898582|NCT03660709|Behavioral|Control|Standard-of-care HIV testing and counseling
15898583|NCT03660683|Drug|Dapagliflozin 10mg|Dapagliflozin 10mg PO QD
15898584|NCT03660683|Drug|Saxagliptin 5mg|Saxagliptin 5 mg PO QD
15898585|NCT03660683|Drug|Placebo Oral Tablet|Matching Placebo Tablets
15898586|NCT03660670|Behavioral|ONCORAL therapeutic education|Multidisciplinary program that includes informative cessions with a hospital pharmacist about the anticancer drug: information is given to the patients on adverse events and their managements, optimizing drug dosage plans. Moreover, information is shared with town partners: doctor, pharmacists, and nurses.
15898587|NCT03660670|Behavioral|Standard of care|In the group of standard of care, patients will have interviews with a clinical research associate only dedicated to the record of data for outcomes assessments.
15898588|NCT03660657|Drug|Ozone|Ozone Group: Standard treatment + Ozone therapy (O3/O2) by rectal insufflation. O3/O2 concentration progressively increased from 10 to 30 µg/ml; 40 sessions in 16 weeks.
15898589|NCT03660657|Drug|Oxygen|Control Group: Standard treatment + Oxygen (O2) by rectal insufflation. O3/O2 concentration = 0 µg/ml (only O2); 40 sessions in 16 weeks.
15898590|NCT03660644|Behavioral|WhatsApp, Pedometer and Step Diary|"Participants will be provided with a daily step diary and added to a group chat on WhatsApp. The group chat will be populated by other members of pulmonary rehabilitation programme (cluster) and the WhatsApp group leader will encourage participants to keep active. Participants will be encouraged to record the number of steps walked in a paper diary at the end of each day (i.e. prior to bedtime). This diary will simply have three columns: day of the week; number of steps; comments (optional).
~The intervention will last 52 weeks."
15898591|NCT03660631|Behavioral|CVRS Intervention|"Evaluate gaps in therapy
~Contact patients regularly by email, phone and/or text message
~Assess and counsel for medication adherence, side effects, life-style behaviors
~Develop an action plan and send recommendations to provider"
15898592|NCT03660618|Device|laser speckle flowgraphy|blood flow state of the skin as real time two dimensional image
15898634|NCT03660306|Procedure|opioid free anesthesia|opioid free anesthesia means giving no opioids during surgery
15898635|NCT03660293|Drug|Atorvastatin|cardio-protective agents
15898636|NCT03660293|Drug|Captopril|cardio-protective agents
15898593|NCT03660605|Other|Rhythmic Auditory Stimulation|Participants will complete 6 weeks of walking training (3x/week). During each session, participants will walk on a treadmill for up to 20 minutes (stepping to a metronome at 85% of typical cadence) followed by overground walking for up to 15 minutes (stepping to a metronome at 115% of typical cadence).
15898594|NCT03660579|Other|HIIT-AB Group|Group that performed HIIT and consumed 330 ml (women) or 2x300 ml (men) of beer with 5.4% alcohol.
15898595|NCT03660579|Other|HIIT-NAB Group|Group that performed HIIT and consumed 330 ml (women) or 2x300 ml (men) of beer without alcohol (0.0%).
15898596|NCT03660579|Other|HIIT-SW Group|Group that performed HIIT and consumed the same amount of sparkling water (0.0%).
15898597|NCT03660579|Other|HIIT-ASW Group|Group that performed HIIT and consumed sparkling water with the same amount of alcohol than the pre-established beer (5.4%).
15898598|NCT03660566|Procedure|Test - Implant with L-PRF|The patient's blood will be collected and the tubes (4) will be inserted into a tabletop centrifuge (Kasvi). Using a 2500rpm for 12 minutes protocol, the leucocyte- and platelet-rich fibrin clot will be prepared using a kit consisting of a perforated metal box where the clots will be positioned and covered by a metal plaque. The pressure exerted on the clot will lead to the formation of L-PRF membranes, which will be used to cover the ridge after placement of the implant. Then, the flap will be sutured.
15898599|NCT03660566|Procedure|Control - Implant without L-PRF|Single implant installation surgery in maxillary esthetic area.
15898600|NCT03660553|Drug|Insulin Glargine|0.40 units/kg body weight
15898601|NCT03660553|Drug|Insulin Glargine|0.20 units/kg body weight
15898602|NCT03660553|Drug|Insulin Aspart|0.20 units/kg body weight
15898603|NCT03660553|Drug|Insulin Lispro|0.20 units/kg body weight
15898604|NCT03660540|Dietary Supplement|Juven|Nutritional supplement (Juven) will be consumed daily per manufacturer recommendations.
15898605|NCT03660527|Other|Not refered|No intervention was refered.
15898606|NCT03660514|Behavioral|Jovenes Sanos|FP counselors in intervention clinics will a) provide counseling and education regarding risk of partner detection of FP methods, and women's and girls' strategies to use FP methods to minimize partner detection risk integrated into standard FP counseling, b) make brief inquiries to allow clients the opportunity to disclose experiences of RC and IPC (i.e., screening), c) provide method-specific counseling based on this information and the method chosen by the client, d) provide supported linkage of IPV survivors to local IPV support services (i.e. warm referral), and e) distribute palm-sized educational materials on RC and IPV, as well as IPV services.
15898607|NCT03660501|Device|Continuous monitoring system|Patients recruited will be continuously monitored with Isansys Lifetouch patch, Isansys wireless blood pressure monitor, Nonin WristOx 3150, Empatica E4, and Radiometer TCM5 FLEX monitor.
15898608|NCT03660488|Drug|Cefixime 400 milligram Oral Capsule [Suprax]|The intervention group will receive Cefixime 400mg, one tablet twice per day, for ten consecutive days
15898609|NCT03660488|Drug|Benzathine Penicillin G|The control group will receive Benzathine Penicillin G 2.4 Million Units intramuscularly for treatment of syphilis. Penicillin is the indicated treatment for syphilis infection
15898610|NCT03660475|Drug|Naltrexone|naltrexone formulated as ophthalmic solution
15898611|NCT03660475|Drug|Placebos|Placebo ophthalmic solution
15898612|NCT03660462|Dietary Supplement|FeSO4 fortified rice test meal|Rice test meal extrinsically labeled with 2 mg ferrous sulfate (58FeSO4)
15898613|NCT03660462|Dietary Supplement|FePO4 fortified rice test meal|Rice test meal extrinsically labeled with 2 mg ferric phosphate (58FePO4)
15898614|NCT03660462|Dietary Supplement|HiFePO4 1 fortified rice test meal|Rice test meal extrinsically labeled with 2 mg high surface ferric phosphate 1 (57FePO4)
15898615|NCT03660462|Dietary Supplement|HiFePO4 2 fortified rice test meal|Rice test meal extrinsically labeled with 2 mg high surface ferric phosphate 2 (57FePO4)
15898616|NCT03660449|Combination Product|Moderately hypofractionated conformal radiation combined With S-1|All patients will receive two cycles of S-1 (40mg/㎡, BID, po) on D1-14, D22-35, combined with thoracic radiotherapy of 60 Gy/24 fractions for GTV and 40 Gy/16 fractions for CTV.
15898617|NCT03660436|Drug|BMS-986165|Specified dose on specified days
15898618|NCT03660436|Drug|MMF|Specified dose on specified days
15898619|NCT03660423|Other|Integrative Dance|Integrative dance may be defined as dance that encourages the participation of all individuals, regardless of ability, supporting and celebrating these differences as a community. In the intervention, adults with developmental disabilities will be dancing in a contemporary dance class alongside college students.
15898620|NCT03660410|Other|Anamnesis|A detailed anamnesis should be carried out in order to know the habits, the presence of systemic pathologies, the use of medication
15898621|NCT03660410|Other|Oral clinical examination|Clinical examination should be carried out evaluating the presence of caries, tooth loss, periodontal condition, occlusal factors
15898622|NCT03660397|Procedure|Selective endovascular chemical ablation of adrenal gland|Intervention with selective endovascular chemical ablation of adrenal gland is performed after adrenal angiography in the group.
15898623|NCT03660397|Drug|Traditional triple antihypertensive treatment|irbesartanhydrochlorothiazide 162.5 mg/d, amlodipine 5 mg/d
15898624|NCT03660384|Procedure|PPV/SO|Subjects receive 1,000 centistoke silicone oil tamponade during vitrectomy
15898625|NCT03660384|Procedure|PPV/C3F8|Subjects receive 16% C3F8 gas tamponade during vitrectomy
15898626|NCT03660371|Procedure|PPV/MP|Internal limiting membrane (ILM) peeling during vitrectomy for the indication of diabetic vitreous hemorrhaging
15898627|NCT03660371|Procedure|PPV without MP|No internal limiting membrane (ILM) peeling during vitrectomy for the indication of diabetic vitreous hemorrhaging
15898628|NCT03660358|Device|kinesiotape application|kinesiotape application to diaphragm, chest wall and abdomen in preterm infants.
15898629|NCT03660345|Procedure|PPV/MP|23 gauge Pars Plana Vitrectomy with Internal Limiting Membrane Peeling
15898630|NCT03660345|Drug|Intravitreal injection|Intravitreal ziv-Aflibercept
15898631|NCT03660332|Procedure|Infusion of a liquid meal intraduodenally|Infusion of IL-6/NaCL before a liquid meal intraduodenally
15898632|NCT03660319|Other|Environmental Music Therapy|Experiencing Environmental Music Therapy during wait time in radiation oncology waiting room.
15898633|NCT03660306|Procedure|opioid anesthesia|opioid anesthesia means using sufentanil during surgery
15898637|NCT03660293|Drug|L-carnitine|cardio-protective agents
15898638|NCT03660280|Dietary Supplement|Probiotics|Specific probiotic lactobacilli (added to stabilized ongoing treatment)
15898639|NCT03660280|Other|Placebo|Placebo
15898640|NCT03660267|Other|caffeine coffee|"drank 3 cups of caffeinated coffee daily (100 mL at 05:00 AM, 10:00 PM, and 15:00 PM), beginning on the morning after surgery Patients were free to drink any amount of water but no more coffee, black tea, or other form of caffeine, such as soda.
~Coffee was prepared with a conventional coffee machine"
15898641|NCT03660267|Other|decaffiene coffee|"drank 3 cups of decaffeinated coffee daily (100 mL at 05:00 AM, 10:00 PM, and 15:00 PM), beginning on the morning after surgery Patients were free to drink any amount of water but no more coffee, black tea, or other form of caffeine, such as soda.
~Coffee was prepared with a conventional coffee machine"
15898642|NCT03660267|Other|still water|"drank 3 cups of still water daily (100 mL at 05:00 AM, 10:00 PM, and 15:00 PM), beginning on the morning after surgery Patients were free to drink any amount of water but no more coffee, black tea, or other form of caffeine, such as soda.
~Coffee was prepared with a conventional coffee machine"
15898643|NCT03660254|Behavioral|tai chi|tai chi exercise intervention，two times a week and each time cost one hour
15898644|NCT03660241|Drug|PF-04965842|PF 04965842 is a janus kinase (JAK) 1 inhibitor that is currently being developed for the treatment of atopic dermatitis (AD).
15898645|NCT03660228|Other|Peri-Transfusion QOL Assessment|Participants will undergo a peri-transfusion quality of life assessment (PTQA) using the Quality of Life in Myelodysplasia Scale (QUALMS)
15898646|NCT03660215|Other|mediation|support throughout their care journey during the 90 days following an emergency visit. This support will be carried out by a specific staff trained in medico-social mediation
15898647|NCT03660202|Device|Firesorb|Implantation of Sirolimus Target Eluting Bioresorbable Vascular Scaffold （Firesorb）
15898648|NCT03660189|Other|Two bag system|The two IV fluid bags have identical fluids and electrolytes, except one has 10% dextrose and the other has no dextrose. The two fluid bags run simultaneously and their rates are adjusted according to the patient's blood sugar.
15898649|NCT03660176|Drug|butyrate enemas + routine management|10ml/kg volume of butyrate enemas in addition to the colonic irrigations
15898650|NCT03660176|Other|routine management|the colonic irrigations
15898651|NCT03660150|Other|Evaluation of health-related quality of life|Short Form-36 Medical Outcomes Survey (SF-36), and Brief Version of Burn Speciﬁc Health Scale (BSHS-B) are used for the present evaluation.
15898652|NCT03660137|Device|MOLLI Localization|All patients will also be implanted with an additional MOLLI seed using a specialized introducer needle. A specialized MOLLI probe will be used to find the magnetic seed during the lumpectomy surgery.
15898653|NCT03660124|Device|Deep Brain Stimulation|DBS is a neurosurgical procedure that involves the administration of small amounts of electricity to disrupt abnormal activity of brain structures associated with disease symptoms. It involves inserting thin electrodes into deep brain structures and electrically stimulating them in a controllable and ultimately reversible manner. The electrodes are connected to an internal pulse generator that is implanted in the upper chest region, below the collarbone.
15898654|NCT03660111|Diagnostic Test|spirometry|only measurement of spirometry
15898655|NCT03660085|Behavioral|PC-PEP|"The 6 months at home program focuses on aerobic and strength training, pelvic floor muscle exercises, meditation, social connection, and overall healthy lifestyle practices supported with daily text message/email reminders. The aerobic (5 times/week) and strength (2 times/week) program will comprise of a single 30-minute session daily and will be individualized to each participant. Pelvic floor muscle training will include three, 10-minute sessions and mediation for 10 minutes daily. Intimacy and Connection component of PC-PEP consists of engaging in at least one form of intimacy practice prescribed, per day. Social connection will be fostered by pairing participants up with peers from the study. To encourage program compliance, study participants will receive 3 daily reminders to do their pelvic floor muscle exercises per day plus an additional motivational email daily containing helpful tips."
15898656|NCT03660072|Other|Non-Interventional|Non-Interventional
15898657|NCT03660059|Drug|Peficitinib|Oral
15898658|NCT03660059|Drug|Plaebo|Oral
15898659|NCT03660059|Drug|Disease-modifying antirheumatic drugs (DMARDs)|"As necessary concomitant medications, DMARDs listed below will be administered orally unless specified.
~For subjects who are inadequate responders to methotrexate (MTX): MTX. For subjects who are intolerant of MTX: either of DMARDs listed; hydroxychloroquine, salazosulfapyridine, gold (injection or oral), D-penicillamine, lobenzarit, actarit, bucillamine and iguratimod."
15898660|NCT03660046|Drug|Depot medroxyprogesterone acetate (DMPA)|Depot medroxyprogesterone acetate (DMPA) will be dispensed from the Grady Pharmacy Service and will be administered every 12 weeks at the standard dose of 150 mg Intramuscular injection, beginning from week 3 of study enrollment and repeated every 13 weeks
15898661|NCT03660046|Drug|Etonogestrel implant (Eng-Implant)|A standard Nexplanon rod Implant that is a subdermal implant in the arm. This will be placed at study week 3 by Dr. Haddad or a trained clinician. It contains Etonogestrel 68mg.
15898662|NCT03660046|Drug|Levonorgestrel IUD (Lng-IUD)|The Levonorgestrel Intrauterine Device (Lng-IUD) (Mirena or copper) will be placed at study week 3 by Dr. Haddad or a trained clinician.
15898663|NCT03660033|Diagnostic Test|ECG in delivery room|See arm/group discussions
15898664|NCT03660020|Drug|Local anesthetic|ultrasound guided erector spine plane block (ESP) will be done in patients under going mastectomy with local anaesthetics only
15898665|NCT03660020|Drug|Hyaluronidase|hyaluronidase will be added to ultrasound guided erector spine plane block (ESP) will be done in patients under going mastectomy
15898666|NCT03660007|Procedure|Fresh or frozen embryo transfer IVF|
15898667|NCT03659994|Dietary Supplement|Multivitamin|Vitabeard
15898668|NCT03659994|Dietary Supplement|Placebo|Placebo
15898669|NCT03659981|Other|MRI 7T|The imaging parameters will come from the 7 Tesla Siemens MRI
15898670|NCT03659968|Other|Physical activity training|brisk walking on treadmill and exercises of muscular strengthening with varying durations and intensities depending on physical capabilities of patients
15898671|NCT03659955|Other|Autologous blood applied to dry eye|See previous description for the study arm.
15898713|NCT03659643|Diagnostic Test|EEG with SPR analysis|qEEG with SPR analysis was performed in group 1 during 2011-2013 and in group 2, the same procedure is performed.
15898848|NCT03658629|Biological|NanoFlu (Quad-NIV)|2018-2019 Investigational Quadrivalent Seasonal Influenza Vaccine
15898672|NCT03659942|Other|CAST questionnaire|the CAST questionnaire will be used to answer the main objective of the study and to identify consumers with problematic cannabis use. This is a validated self-questionnaire in France (Legleye et al., 2011), specific to the adolescent population, which is interpreted according to the score obtained (Bastiani et al., 2013, Legleye et al. 2007, Legleye et al., 2011). It includes 6 items with answer modes coded from 0 to 4. The total score obtained by summing these 6 items can therefore vary from 0 to 24. We define users without risk for a score of less than 3, users with low risk for a score greater than or equal to 3 and less than 7, and finally those with a risk of problematic use for a score greater than or equal to 7
15898673|NCT03659929|Drug|Amphetamine Sulfate|active experimental AR19
15898674|NCT03659929|Drug|Placebo|Matching placebo
15898675|NCT03659916|Drug|A4250 (odevixibat)|A4250 is a small molecule and selective inhibitor of IBAT
15898676|NCT03659903|Procedure|pancreaticoduodenectomy|pancreaticoduodenectomy
15898677|NCT03659890|Dietary Supplement|Low nucleotide|2 week, twice daily, supplementation with a nucleotide-depleted mycoprotein drink, with added dextrose
15898678|NCT03659890|Dietary Supplement|High nucleotide|2 week, twice daily, supplementation with a nucleotide-rich mycoprotein drink, with added dextrose
15898679|NCT03659890|Dietary Supplement|High nucletide + Ribose|2 week, twice daily, supplementation with a nucleotide-rich mycoprotein drink, with added ribose
15898680|NCT03659877|Behavioral|Physical activity|Participants will undertake a variety of typical daily physical activities, such as laying down, sitting, walking whilst wearing accelerometers and gas analysis equipment.
15898681|NCT03659864|Other|diesel exhaust particulate|aerosolised diesel exhaust particulate
15898682|NCT03659864|Other|carbon nanoparticles|aerosolised 'clean' carbon nanoparticles
15898683|NCT03659864|Other|small graphene oxide|aerosolised 'small' graphene oxide
15898684|NCT03659864|Other|ultrasmall graphene oxide|aerosolised 'ultrasmall' graphene oxide
15898685|NCT03659864|Other|filtered air|control: filtered air
15898686|NCT03659851|Drug|Levosimendan 2.5 MG/ML Injectable Solution|LVAD implantation
15898687|NCT03659825|Dietary Supplement|Ketone Ester|Flavored sports drink containing deltaG (betahydroxybutyrate monoester) as the sole active ingredient, diluted with water.
15898688|NCT03659825|Dietary Supplement|Taste Matched Placebo|Placebo that tastes similar to active intervention
15898689|NCT03659825|Other|Hypoxic exposure|Participants will breath through a mask to provide the amount of oxygen typically seen at 16-17,000ft of altitude.
15898690|NCT03659812|Other|MACS technique|MACS is a technique that allow us to tag and detect apoptotic spermatozoa. These apoptotic spermatozoa have phosphatidylserine in their membranes, so we add magnetic beads with Annexin V, which binds specifically to phosphatidylserine. The spermatozoa are then tagged and can be retained in a magnetic field, allowing us to collect just the non-apoptotic spermatozoa.
15898691|NCT03659799|Drug|Insulin FiAsp|An insulin bolus of FiAsp will be given 5 minutes before breakfast
15898692|NCT03659799|Drug|Insulin Aspart|An insulin bolus of Aspart will be given 5 minutes before breakfast
15898693|NCT03659799|Other|60-minutes postprandial exercise|A 60-minute exercise at 60% of VO2 peak will be performed 60 minutes after breakfast
15898694|NCT03659799|Other|120-minutes postprandial exercise|A 60-minute exercise at 60% of VO2 peak will be performed 120 minutes after breakfast
15898695|NCT03659786|Other|CC-Test|Classification of the oocyte/embryo based on the expression pattern observed in the cumulus cells
15898696|NCT03659773|Biological|immune biomarkers to evaluate vaccine response in HSCT recipients|a 38mL-blood sample will be collected before and at 3, 12 and 24 months after complete block vaccination and at 4 weeks after influenza vaccination for the ancillary study
15898697|NCT03659760|Other|Group Isolated|Eyes closed with patch and ears plugged between 24:00-06:00
15898698|NCT03659747|Dietary Supplement|Probiotic|- 6 g sachet containing probiotic powder (1.8 x 10^12 CFU Probiotic) in sachet - One sachet of the investigational product will be consumed with 521 ml of Weihenstephan fat-free milk once in the beginning of a 6-hour challenge at a study visit.
15898699|NCT03659747|Dietary Supplement|Lactrase|- 6 g sachet containing 4500 Food Chemical Codex (FCC) units of lactase (Lactrase, Oy Verman Ab, Kerava, Finland) and maltodextrin as a carrier - One sachet of the investigational product will be consumed with 521 ml of Weihenstephan fat-free milk once in the beginning of a 6-hour challenge at a study visit.
15898700|NCT03659747|Other|Placebo|- 6 g sachet containing placebo powder (maltodextrin) in sachet - One sachet of the investigational product will be consumed with 521 ml of Weihenstephan fat- free milk once in the beginning of a 6-hour challenge at a study visit.
15898701|NCT03659734|Behavioral|Motivational Interviewing and Gradual Opioid Weaning|Following surgery, participants will undergo motivational interviewing with a trained member of the study staff. These calls will occur weekly for 6 weeks with a follow-up call at 10 weeks or until the participant completes the protocol.
15898702|NCT03659734|Behavioral|Enhanced Usual Care|Following surgery, participants will receive phone calls from a trained member of the study staff to discuss various aspects of surgical recovery and medication use. These calls will occur weekly for 6 weeks with a follow-up call at 10 weeks or until the participant completes the protocol.
15898703|NCT03659721|Behavioral|FACAM|Support person
15898704|NCT03659721|Behavioral|Care as Usual|Usual care
15898705|NCT03659721|Behavioral|COS-P|Attachment based therapy
15898706|NCT03659708|Procedure|Lyon-VTE score|follow-up at 3 months, 5 months, 7 months during pregnancy and 3 months and 12 months after delivery.
15898707|NCT03659708|Procedure|recommendations currently available|follow-up at 7 months during pregnancy and 3 months and 12 months after delivery.
15898708|NCT03659695|Dietary Supplement|Grape Powder|69 g/d freeze dried grape powder
15898709|NCT03659695|Dietary Supplement|Placebo Powder|69 g/d placebo powder matched for taste and appearance
15898710|NCT03659682|Drug|Semaglutide|subcutaneous, 1.0 mg, weekly, 48 months
15898711|NCT03659656|Behavioral|Lifestyle coaching|Goal setting and behavior change barriers will be discussed through lifestyle behavioral change coaching. Personalized weekly physical activity achievement report will also be sending to participants in experimental group. The participants will also have a Fitbit to use for 3 months.
15898712|NCT03659656|Device|Fitbit usage|The participants will have a Fitbit to use for 3 months.
15898849|NCT03658629|Other|Matrix-M Adjuvant|Adjuvant
15898714|NCT03659630|Behavioral|MyCompass|Self-help tools to change behaviours in various different domains including sleep deprivation, anxiety and depression.
15898715|NCT03659630|Behavioral|Comparison group|An email containing a brief text on general tips regarding mental health was sent out once a week.
15898716|NCT03659617|Device|xenograft (BioOss Collagen)|Alveolar ridge preservation using xenograft (BioOss Collagen) and implant placement at 3 different time intervals (3, 6 and 9 months)
15898717|NCT03659604|Behavioral|'SmartLife' with tailored feedback|'SmartLife' game with tailored feedback: mobile exergame with tailored feedback. Feedback will be based on accelerometer data from a sensor that is integrated in a T-shirt. The sensor captures individually calibrated accelerometer data and is paired with the mobile exergame. Depending on the physical activity intensity of the player, the game challenge and feedback adapts individually in real-time.
15898718|NCT03659604|Behavioral|'SmartLife' without tailored feedback|'SmartLife' without tailored feedback: mobile exergame without tailored feedback. The mobile exergame will not be paired to any sensor. The participant can play the mobile game, yet, will not receive any real-time feedback or adjustment in the game on physical activity intensity.
15898719|NCT03659604|Behavioral|No game|Passive control: School classes will be asked to continue their daily life as usual.
15898720|NCT03659591|Behavioral|Cognitive Behaviour Therapy|CBT will be delivered in group format, consisting of 10 weekly two-hour sessions, with 10 participants per group
15898721|NCT03659591|Behavioral|Adaptive Psychological Training|APT will be delivered in group format, consisting of 5 weekly two-hour sessions, with 20 participants per group
15898722|NCT03659578|Drug|Concurrent chemotherapy|Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration.
15898723|NCT03659578|Radiation|split-course radiotherapy|split-course chest radiation at 51Gy/17f and 15Gy/5f
15898724|NCT03659578|Drug|thymosin alpha 1|subcutaneous injections of thymosin once a week,1.6mg each time from the start of radiation to 2 months after the end of radiation.
15898725|NCT03659565|Behavioral|Enhanced Pre-Visit Consultation|The Intervention Group will be given access to the optimized personal health record and will use Zoom as part of the pre-visit consultation.
15898726|NCT03659565|Behavioral|Usual Care Control|Caregivers and patients will participate in usual pre-visit process.
15898727|NCT03659552|Device|LIVE Catheter|Placement of a temporary LIVE Catheter central venous pacing device in the left jugular vein to pace the phrenic nerves and allow recruitment of the diaphragm muscle.
15898728|NCT03659539|Drug|PROPOFOL|Propofol delivery will be controlled using automated closed loop anaesthesia delivery system which will control propofol delivery rate to consistent anaesthetic depth (BIS-50) feedback from the patient.
15898729|NCT03659539|Drug|Desflurane|Desflurane delivery will be controlled using a agent specific vaporiser. The dial concentration of the vaporiser will be adjusted to maintain a BIS of 50-55 in the patients.
15898730|NCT03659526|Diagnostic Test|Deformation imaging|Deformation parameters derived using myocardial velocity imaging or speckle tracking
15898731|NCT03659500|Diagnostic Test|Four-week routine bloodwork|Routine hemodialysis bloodwork done every 4 weeks
15898732|NCT03659500|Diagnostic Test|Six-week routine bloodwork|Routine hemodialysis bloodwork done every 6 weeks
15898733|NCT03659487|Procedure|Nissen|Laparoscopic total (Nissen) fundoplication
15898734|NCT03659487|Procedure|Toupét|Laparoscopic posterior 270 degrees partial fundoplication
15898735|NCT03659474|Other|compression|compression by Game Ready
15898736|NCT03659474|Other|ice pack|cryotherapy for ice pack
15898737|NCT03659474|Other|immersion|immersion therapy
15898738|NCT03659461|Drug|Sitagliptin|oral 100mg Sitagliptin daily will be given for 12 weeks. Subjects are required to undergo OGTT pre and post treatment.
15898739|NCT03659448|Drug|SGM-101|A fluorochrome-labeled anti-carcinoembryonic antigen (CEA) monoclonal antibody intraoperative imaging agent.
15898740|NCT03659435|Drug|RID-TDS 9.5 mg/24 h|3 consecutive applications of 1 patch (1st patch for 4 days, 2nd patch for 3 days, 3rd patch for 4 days) covering an 11-day period
15898741|NCT03659435|Drug|Exelon® 9.5 mg/24 h|11 consecutive applications of 1 patch (each patch will be applied for 1 day) covering an 11-day period
15898742|NCT03659422|Other|Modified Paleolithic diet|The diet eliminates legumes, grains and nightshades (as opposed to the Paleolithic diet) and is higher in vegetable and fruit intake and in omega-3 fatty rich foods.
15898743|NCT03659409|Behavioral|Mindfulness-Based Intervention|4 weekly 2-hour sessions. Participants will be introduced, taught and guided in practice of mindfulness-based interventions that are focused on their (1) breath, (2) senses, (3) body and bodily movements, (4) feelings of empathy and compassion.
15898744|NCT03659409|Behavioral|Waitlist - Mindfulness-Based Intervention|Participants in this group will only receive the Mindfulness-Based Intervention 3-months after they have started the study and baseline measurements. While participants in the Intervention Arm are receiving the treatment, this group will receive No intervention for the first four weeks and will continue as treatment as usual until it is their turn to receive the Intervention.
15898745|NCT03659396|Other|individualized Tai Chi|individualized Tai Chi training exercise
15898746|NCT03659396|Other|Entire Tai Chi|the classical Yang style Tai Chi program
15898747|NCT03659396|Other|home-based program|Home-based exercise
15898748|NCT03659383|Combination Product|Optimal hypoglycemic treatment|Standardize oral hypoglycemic medication and adjust insulin dose according to blood glucose values obtained by self-monitoring
15898749|NCT03659370|Other|Fumigation|use Fumigation to increase the improvement of osteoarthritis of knee
15898750|NCT03659370|Other|Acupuncture|Acupuncture
15898751|NCT03659344|Drug|Vicryl plus|Using vicryl sutures which coated with triclosan (antibiotic)
15898752|NCT03659331|Dietary Supplement|Zinc|blood tests will be performed: GGT SGOT, SGPT, LDH, A.P. Direct and indirect bilirubin, blood proteins, cholesterol, P.T. and a complete blood count.
15898846|NCT03658655|Biological|Stem Cells From Human Exfoliated Teeth|"Basic treatment:
~The original treatment regimen will be maintained during the study period, insulin dose could be adjusted with the change of blood glucose, while the type and dose of oral hypoglycemic drugs remained unchanged (except when side effects of drugs or insulin preparations were stopped, but patients still had frequent hypoglycemia).
~Stem cell therapy:
~Usage: drip slowly, 50ml normal saline first, then Stem Cells From Human Exfoliated Teeth (during 60 min), then 50ml normal saline."
15898753|NCT03659318|Procedure|Robotic-assisted TKA|Total knee arthroplasty is carried out with help of robotic surgery system, using a Robodoc system. CT-based preoperative planning using ORTHODOC (Integrated Surgical Technology Corp) performed in the first step before the day of surgery, and the robotic-assisted surgery using the ROBODOC surgical assistance in the second step. The bone markers are registered to the computer, and the computer arm does all the cutting and preparation of bones. This is in contrast to conventional jigs and cutting blocks. Actual implantation of the implants is done by a surgeon. A Duracon posterior cruciate-substituting total knee prosthesis (Stryker Orthopedics, Mahawh, NJ, USA) are used in all knees.
15898754|NCT03659318|Procedure|Conventional TKA|Total knee arthroplasty is carried out with classical, conventional, manual method. A surgeon measures the angle, length of the cuts with bone landmarks and specialized surgical instruments. After all the cuts actual implantation is done. A Duracon posterior cruciate-substituting total knee prosthesis (Stryker Orthopedics, Mahawh, NJ, USA) are used in all knees.
15898755|NCT03659305|Biological|RPH-001|Concentrate for preparation solution for infusion in ampules, 25 mg/mL
15898756|NCT03659305|Biological|Avastin|Concentrate for preparation solution for infusion in ampules, 25 mg/mL
15898757|NCT03659292|Other|GEA|Thoracic epidural catheterization will be performed and epidural anesthesia will be maintained with 0.25% ropivacaine during surgery. General anesthesia will be maintained with inhalation (sevoflurane) and muscle relaxants will be administered when considered necessary.
15898758|NCT03659292|Other|PCEA|Patient-controlled epidural analgesia (0.15% ropivacaine and 0.5ug/ml sufentanil infusion) will be provided after surgery.
15898759|NCT03659292|Other|GA|General anesthesia will be maintained with inhalation (sevoflurane) and sufentanil infusion, and muscle relaxants will be administered when considered necessary.
15898760|NCT03659292|Other|PCIA|Patient-controlled intravenous analgesia (1ug/ml sufentanil) will be provided after surgery.
15898761|NCT03659279|Behavioral|Let's Get Organized|Group intervention aiming to enhance time-management, targeted to persons with mental or neurodevelopment disorders. Each group has 6-8 participants and is lead by two trained group leaders. Goal-directed and other learning strategies are used to train effective time management habits such as maintaining a calendar and wearing a watch. Group sessions are structured with a PowerPoint presentation and a course manual, and information from the group leaders is intermixed with discussion among the participants and tasks to complete.
15898762|NCT03659266|Other|Robotic walking rehabilitation by Lokomat®|Lokomat sessions / week for 2 weeks. Each session lasts 45 minutes including 30 minutes of effective work of the march and 15 minutes of setting up.
15898763|NCT03659266|Other|Conventional walking rehabilitation|5 physiotherapy sessions / week for 2 weeks. Each session lasts 45 minutes including 30 minutes of walking and 15 minutes of stretching
15898764|NCT03659253|Diagnostic Test|Oral Fluid Based Self Testing|The intervention will introduce provider supervised and unsupervised self-testing as an option for early HIV diagnosis among MSM community in Denpasar Bali Indonesia.
15898765|NCT03659253|Procedure|Simplified ART Initiation|In this intervention, there will be a change in the clinical practice of ART initiation. In the current practice, clients are asked to perform full pre-ART laboratory examination (complete blood count, liver and renal function tests) before decision of ART initiation. In this intervention, the study participants who are already confirmed as HIV positive and meet specific clinical criteria (see below) will initiate ART (antiretroviral therapy) immediately (after clients' approval) without having to perform full pre-ART laboratory examination. Here, laboratory criteria for initiating ART will be simplified and specific laboratory examination, I.e. creatinine test will be delayed in two weeks after ART initiation.
15898766|NCT03659253|Procedure|CBO AND BROTHEL-BASED ART SERVICE|The CBOs involved in this intervention are Kebaya and Vesta. Kebaya is an CBO working for Transgender (TG) community. It serves as community gathering place for TG and others, as HIV testing site on regular bases, and also as shelter for homeless HIV patients. The proposed intervention Is that HATI Project will provide HIV testing and treatment in the community, CBO and brothel in collaboration with nearby Puskesmas.
15898767|NCT03659253|Behavioral|SMS REMINDER|HATI SMS reminder: short message services as reminders to inform ART patients when to take medication, visit the clinics (1 week before the next visit) and remind if they miss clinic appointment.
15898768|NCT03659253|Procedure|MOTIVATIONAL INTERVIEWING|"The approach used in this intervention is an individual counselling with a MI approach, as it is considered a brief form of therapy have been known to be effective in improving HIV treatment adherence.
~The sessions will be held from 3 to up to 10 MI counselling over 6-month period of intervention. The goal of this intervention is to help PWID gain an understanding of their medication-taking behaviors and the actions necessary to successfully maintain a high level of adherence"
15898769|NCT03659240|Other|Cranberry beverage|During the intervention period, research participants will consume a cranberry beverage daily.
15898770|NCT03659240|Other|Placebo beverage|During the intervention period, research participants will consume a placebo beverage daily.
15898771|NCT03659214|Behavioral|Questionnaires|Answering 4 questionnaires : anxiety, depression, quality of life and adherence
15898772|NCT03659201|Drug|Neosil complete|Oral, during 24 weeks.
15898773|NCT03659201|Drug|Pantogar|Oral, placebo for 12 weeks and pantogar for 12 weeks.
15898774|NCT03659201|Drug|Neosil|Oral, during only 12 weeks.
15898775|NCT03659188|Procedure|Corticotomy with drills|Mechanical drills will be used on a handpiece
15898776|NCT03659188|Procedure|Traditional Corticotomy|Piezo-surgery will be employed following flaps' elevation.
15898777|NCT03659175|Other|SIBO|SIBO: Small intestinal bacterial overgrowth, refers to a bacterial overgrowth due to organic or functional stasis in small intestine, leading to the change in number or types of bacteria in small intestine.
15898778|NCT03659162|Drug|Azole Antifungal|oral gel & injections
15898779|NCT03659149|Drug|CKD-333 formulation I|1 tablet administered before the breakfast(single-dose)
15898780|NCT03659149|Drug|CKD-333 formulation II|1 tablet administered before the breakfast(single-dose)
15898781|NCT03659149|Drug|CKD-330+D086|2 tablet administered before the breakfast(single-dose)
15898850|NCT03658629|Other|Placebo|Placebo
15918502|NCT03509012|Drug|Paclitaxel|IV
15898786|NCT03659123|Behavioral|standardized geriatric intervention|"Nutritional care is based on:
~A personalized evaluation of nutritional balance and nutritional needs of the patient
~A weekly follow-up of weight and nutritional intake
~Total-body rehabilitation is based on:
~2 to 3 times a week: strength exercise
~2 to 3 times a week: endurance exercise, 20 to 45 min each sequence
~2 times a week: respiratory physiotherapy Pharmaceutical conciliation and optimization according STOPP/START criteria During peri-operative time, the nurse contacts the surgical team for transmission of patient's personal data, physical medication conciliation results During rehabilitation time and hospital-home transition time, the nurse contacts the rehabilitation team for transmission of patient's personal data and care course, physical (nutritional, functional and/or comorbidities), medication conciliation results."
15898787|NCT03659110|Biological|HPV 4|1000 subjects will be received the HPV 4 vaccine
15898788|NCT03659097|Procedure|periodontally accelerated osteogenic orthodontics|Surgery will be performed to the lower anterior bony segment of the lower jaw in order to accelerate tooth movement
15898789|NCT03659084|Drug|EXJADE|The patient having given his consent, will begin the Exjade at 10 mg / kg per day if the ferritin level reached 1000 ng / ml at 6 months after allograft, for a minimum duration of three months and up to 6 months. The iron parameters will be evaluated at 3, 6, 9, 12, 18 and 24 months after the beginning of the exjade treatment. The evaluation of the disease will be carried out according to the practices of the center. It is recommended to have a washout period of one week between stopping the ciclosporin and the beginning of treatment by exjade.
15898790|NCT03659071|Other|questionnaire VSP-A|VSP-A (écu et Santé Perçue de l'Adolescent et de l'enfant): Lived and perceived health of the adolescent and child developed from the exclusive point of view of the child, for which reference values in French population are available. The self-questionnaire used is a questionnaire developed and validated in French for children and adolescents, according to the standards in force, apprehending 9 dimensions (vitality, psychological well-being, relations with friends, leisure, family relations, good physical, relationships with teachers, school work, self-esteem)
15898791|NCT03659058|Drug|silymarin|silymarin 140 three times daily
15898792|NCT03659058|Drug|Ursodeoxycholic Acid|Ursodeoxycholic Acid 500
15898793|NCT03659058|Drug|Antioxidants|Beta Carotene - 6Mg Vitamin C - 200Mg Vitamin E - 50Mg
15898794|NCT03659058|Drug|Colchicine|Colchicine 0.6
15898795|NCT03659058|Other|FOLLOW UP|follow up by abdominal ultrasound and fibroscan every 6 month for 1 year
15898796|NCT03659045|Other|scale of pain|The measurement is simple, reproducible, performed using a scale of pain rated from 0 to 10 (0 absence of pain, 10 maximum of pain felt)
15898797|NCT03659032|Procedure|Pediatric Manual Therapy|
15898798|NCT03659032|Procedure|Educational Physical Therapy|
15898799|NCT03659019|Other|Quality of life questionnaires|During 10 years, the study will be conduct to obtain the quality of life evolution and medical complications in patients candidates but not implanted, and in patients candidates then implanted with the phrenic nerve stimulator.
15898800|NCT03659006|Biological|Biological Collection|Blood sampling on catheter and CSF sampling from VDE, multimodal MRI at D42 and D365, Neurological and neuropsychological evaluation at one year
15898801|NCT03658993|Drug|Rifaximin 550 MG|Oral Rifaximin 550 mg TID for 4 weeks.
15898802|NCT03658980|Behavioral|Health Education Intervention|Face-to-face health education intervention on Diabetic Retinopathy and available services at a tertiary hospital, followed by telephonic reminder at Day 7, 30 and 90.
15898803|NCT03658967|Drug|Lymfactin® (1x10E11 vp)|Lymfactin® will be administered as a single dose via perinodal injection in a volume of 2 mL.
15898804|NCT03658967|Drug|Placebo|Placebo will be administered as a single dose via perinodal injection in a volume of 2 mL.
15898805|NCT03658954|Behavioral|Advice|Once per week for two weeks, participants will come to in-person visits to receive brief web-based sleep hygiene advice.
15898806|NCT03658954|Behavioral|Self-monitoring|Participants will complete daily web-based sleep and alcohol diaries for two weeks.
15898807|NCT03658954|Behavioral|Feedback|Participants will receive feedback once per week for two weeks on their sleep and alcohol consumption, using all possible data derived from Fitbit actigraphs and Milo Sensor blood-alcohol trackers.
15898808|NCT03658941|Procedure|No dural tenting techniques|Not applying dural tenting sutures during closure of a craniotomy
15898809|NCT03658941|Procedure|Dural tenting techniques|Applying at least 3 dural tenting sutures during closure of a craniotomy
15898810|NCT03658915|Device|Smartphone application (Goniometer Pro )|Knee repositioning error will be measured simultaneously by smartphone and Biodex isokinetic dynamometer by a single blind assessor. All assessments will be done with eyes closed and repeated over two separate sessions, with one-week interval in-between. For active repositioning, the participant will actively extend the knee to reach a predetermined target position45° flexion at an angular velocity of 10°/sec. For passive knee repositioning, the isokinetic dynamometer will move the knee at 5°/s to a predetermined angle between 5° and 80° of flexion and the participant should stop the movement when the predetermined angle is reached.
15898811|NCT03658876|Drug|Iron Sucrose Solution for Injection|200mg iron sucrose given on 5 successive haemodialysis sessions
15898812|NCT03658876|Drug|Epoetin Beta|Uptitration of epoetin beta dose. Scale as follows (in units /session): 0-1000-2000-3000-4000-6000-8000-12000
15898813|NCT03658863|Procedure|endoscopic ultrasound|Evaluation of bile ducts with endoscope with special ultrasonographic function
15898814|NCT03658863|Procedure|intraoperative cholangiography|evaluation of bile ducts by injecting radiocontrast media to cystic duct during laparoscopic cholecystectomy
15898815|NCT03658863|Procedure|ERCP|evaluation of bile ducts by injecting radiocontrast media to common bile duct via endoscope inserted to duodenum
15898816|NCT03658863|Device|Ultrasound endoscope|Endoscope with built-in ultrasound function
15898817|NCT03658850|Drug|Hydrochlorothiazide 50Mg|for the experimental group received a hydrochlorothiazide tablet on presentation of 50mg or equivalent enteral solution every 12h (total of 100mg per day) enterally on day 0 (D0) until day 3
15898818|NCT03658850|Drug|Placebos|for the placebo group will receive one tablet or equivalent volume of enteral solution of inert substance, identical to the hydrochlorothiazide presentations, every 12 hours until day 3
15898819|NCT03658837|Procedure|Ivor Lewis Oesophagectomy|Patients who underwent Ivor-Lewis Oesophagectomy for cancer of oesophagus
15898851|NCT03658629|Biological|Fluzone HD|2018-2019 Licensed Trivalent Seasonal Influenza Vaccine
15898820|NCT03658824|Other|Behavioural Activation (BA)|"BA is based on the assumption that depression may be precipitated and is maintained by a reduction in healthy, adaptive behaviours and positive reinforcement of these, and an increase in avoidance behaviours. Together, these changes reduce the person's immediate distress, often at the expense of their medium and longer term goals. The therapy involves helping the individual to re-establish healthy patterns of activity, and replace avoidance behaviours with more adaptive behaviours that are constructive in the longer term.
~The intervention consists of up to 20 individual therapy sessions of Behavioural Activation, with one booster session three months after the end of therapy. Each session lasts approximately 50 minutes and this is supplemented by home practice between sessions."
15898821|NCT03658811|Device|intense pulsed light|Use of 6 mm SapphireCool light guide to treat upper lid margins from tragus to tragus including the nose
15898822|NCT03658798|Procedure|Functional Electrical Stimulation|Study participants will receive 40 sessions of intervention, 3 to 5 times a week over 2 to 3 months. Each session will be one hour in duration and participant will receive functional electrical stimulation therapy with their customized shirt. During therapy participants will be expected to carry out functional movements with assistance from the FES Garment.Participants will be expected to don, activate, and doff the garment as independently as possible. The exercises conducted will be defined by the investigator based on the functional status of the participant and eventual progress.
15898823|NCT03658785|Biological|TIL|On day 0, cells will be infused intravenously over 20 to 30 minutes (one to four days after the last dose of fludarabine)
15898824|NCT03658785|Drug|Aldesleukin|Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses.)
15898825|NCT03658785|Drug|Cyclophosphamide|On day -7 and day -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hr.
15898826|NCT03658785|Drug|Fludarabine|Days -7 to -3: Fludarabine 25 mg /m2/day IVPB daily over 30 minutes for 5 days
15898829|NCT03658759|Procedure|Extracorporeal Cardiopulmonary Resuscitation|local ECPR clinical pathway, including transport with mechanical chest compression device and rapid response VA-ECMO
15898830|NCT03658746|Drug|two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline)|Patients will receive a 14-day quadruple therapy for the H.pylori eradication. The regimen contains one proton pump inhibitor, colloidal bismuth pectin and two sensitive antibiotics determined by antimicrobial susceptibility test. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline will be evaluated.
15898831|NCT03658746|Drug|one proton pump inhibitor, colloidal bismuth pectin|All patients need these two drugs.
15898832|NCT03658746|Drug|two antibiotics based on personal medication history(amoxicillin,levofloxacin, furazolidone)|Patients will receive a 14-day quadruple therapy according to personal medication history for helicobacter pylori eradication. The regimen contains one proton pump inhibitor, Colloidal Bismuth Pectin and two antibiotics based on personal medication history. If the patient hasn't been treated with levofloxacin previously, he will be treated with amoxicillin and levofloxacin. Otherwise, he will be treated with amoxicillin and furazolidone.
15898833|NCT03658733|Drug|esomeprazole, amoxicillin, tetracycline, furazolidone (only for the first 7 days), colloidal bismuth pectin (for the second 7 days)|Patients will go through a gastroscopy and antimicrobial susceptibility test. Liver and kidney function will be monitored by blood test before and after the treatment. Then, patients will receive a 14-day modified sequential therapy containing esomeprazole for the Helicobacter pylori eradication. The regimen contains a double dose esomeprazole, amoxicillin, tetracycline and furazolidone for the first 7 days, followed by esomeprazole, amoxicillin , tetracycline and colloidal bismuth pectin for the second 7 days.
15898834|NCT03658733|Drug|rabeprazole, amoxicillin, tetracycline, furazolidone (only for the first 7 days), colloidal bismuth pectin (for the second 7 days)|Patients will go through a gastroscopy and antimicrobial susceptibility test. Liver and kidney function will be monitored by blood test before and after the treatment. Then, patients will receive a 14-day modified sequential therapy containing rabeprazole for the Helicobacter pylori eradication. The regimen contains a double-dose rabeprazole, amoxicillin, tetracycline and furazolidone for the first 7 days, followed by rabeprazole, amoxicillin , tetracycline and colloidal bismuth pectin for the second 7 days.
15898835|NCT03658720|Drug|200 mg Ibuprofen acid orodispersible tablet|orodispersible tablet
15898836|NCT03658707|Other|questionnaire|Shoulder questionnaire
15898837|NCT03658694|Procedure|rTMS high dose - stage 1|Patients will be undergoing to transcranial magnetic stimulation session with high dose 3000 pulses
15898838|NCT03658694|Procedure|rTMS sham - stage 1|Patients will be undergoing to sham transcranial magnetic stimulation session with high dose 3000 pulses
15898839|NCT03658694|Procedure|high dose rTMS - stage 2|Patients will be undergoing to transcranial magnetic stimulation session with high dose 3000 pulses
15898840|NCT03658694|Procedure|low dose rTMS - stage 2|Patients will be undergoing to transcranial magnetic stimulation session with low dose 1500 pulses
15898841|NCT03658681|Other|Saturated fat 14.9 E%|Dietary cross-over study with saturated fat
15898842|NCT03658681|Other|Polyunsaturated fat 13.6 E%|Dietary cross-over study with polyunsaturated fat
15898843|NCT03658668|Device|active tDCS|tDCS is a therapeutic treatment that utilizes low amplitude direct currents (<4 mA) to induce changes in cortical excitability.
15898844|NCT03658668|Device|sham tDCS|During a sham session, the device is programmed to ramp up to the desired intensity (target 2.5 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then againat the end of the session. These brief periods of stimulation serveto mimic the effects of a true stimulation session.
15898845|NCT03658668|Other|Physical Activity (PA)|20 minutes of cycling on an ergonomic cross-trainer
15898847|NCT03658642|Behavioral|Clinical Decision Support (CDS)|This clinical decision support tool will improve the clinician's ability to identify those with OUD, initiate BUP and refer the patient to ongoing Medication Assisted Treatment (MAT)
15898885|NCT03658369|Dietary Supplement|Lanconone®|2 capsules
15898852|NCT03658629|Biological|Flublok Quadrivalent|2018-2019 Licensed Quadrivalent Seasonal Influenza Vaccine
15898853|NCT03658616|Drug|WO3970|Application of cream to each axilla
15898854|NCT03658616|Drug|Placebo (WO3988)|Application of cream to each axilla
15898855|NCT03658603|Procedure|thoracodorsal artery perforator flap|fascio-cutaneous flap used in cases of trauma or burns
15898856|NCT03658603|Procedure|latissimus dorsi flap|musculo-cutaneous flap used in cases of trauma or burns
15898857|NCT03658590|Drug|Dexamethasone|a prefilled syringe with two milliliters (8 mg) of dexamethasone intravenously
15898858|NCT03658590|Drug|Distilled Water|a prefilled syringe with two milliliters of distilled water intravenously.
15898859|NCT03658564|Dietary Supplement|Preoperative Oral Carbohydrate Drink|Patients in Oral carbohydrate group consumed 400 ml Preoperative Oral Carbohydrate Drink Nutricia preOp® (12.5% carbohydrates, 0.5kcal/ml, 240 mOsm, pH 4.9, Nutricia Zoetermeer, the Netherlands) 3 hours prior to induction of anesthesia and finished the ingestion within 20 minutes.
15898860|NCT03658551|Diagnostic Test|Fluorescein|Measurement of intensity in the gastrointestinal mucosa after intravenous administration of fluorescein by confocal endoscopy
15898861|NCT03658538|Device|Active HEPA Air Cleaner|The active treatment arm will receive two active air cleaners with HEPA and carbon filters to support a home smoking ban and SHS reduction.
15898862|NCT03658538|Behavioral|Motivational interviewing|"The active treatment arm will receive 4 sessions of phone based motivational interviewing to support a home smoking ban and SHS reduction (in addition to the smoking cessation counseling received by all study participants).
~The Control arm will receive only continued counseling for smoking cessation."
15898863|NCT03658538|Device|Sham Air Cleaner|The Control arm will receive sham air cleaners
15898864|NCT03658525|Device|MR LINAC|MR GUIDED PROSATE RADIOTHERAPY
15898865|NCT03658499|Behavioral|two day skills group plus treatment adjuncts|The modified dialectical behavior therapy protocol for victims of intimate partner violence dedicates additional time to address validation of self and others in order to mitigate the impact of punishing social relations, and increase the victims' access to positive reinforcement (Iverson et al., 2009). The modified protocol covers the same four major modules as the original DBT protocol in an abbreviated manner. Participants in this group will be provided with the treatment adjuncts.
15898866|NCT03658499|Behavioral|two day skills group control group|The modified dialectical behavior therapy protocol for victims of intimate partner violence dedicates additional time to address validation of self and others in order to mitigate the impact of punishing social relations, and increase the victims' access to positive reinforcement (Iverson et al., 2009). The modified protocol covers the same four major modules as the original DBT protocol in an abbreviated manner. Participants in this group will not be provided with the treatment adjuncts and will serve as the control group
15898867|NCT03658486|Other|Exercise|Exercise programs will be individually tailored to the capabilities of each participant and gradually progressed accordingly. Each patient will be assigned a moderate intensity walking and strengthening program to complete at home. At baseline, 12 and 24 weeks patients will wear an accelerometer to determine activity levels. At these time points, patients will also complete a physical fitness assessment (timed sit-to-stand and six minute walking tests) and a range of quality of life questionnaires. At baseline, patients will receive a behaviour change consultation and continued support throughout the intervention. Each patient will receive a pedometer during the home-based, unsupervised regime to monitor step count and they are expected to complete a daily physical activity diary. Upon completion of the 24 week follow-up, patients will be invited to partake in semi-structured interviews to determine the effectiveness of the program and their experience throughout.
15898868|NCT03658473|Drug|550 mg naproxen + 300 mg rebamipide + 20 mg rabeprazole.|Oral administration of 550 mg naproxen 2x daily + 300 mg rebamipide 2x daily + 20 mg rabeprazole 1x daily over 7 days.
15898869|NCT03658473|Drug|550 mg naproxen + placebo + 20 mg rabeprazole|Oral administration of 550 mg naproxen 2x daily + placebo of rebamipide 2x daily + 20 mg rabeprazole 1x daily over 7 days.
15898870|NCT03658473|Drug|550 mg naproxen + 300 mg rebamipide + placebo|Oral administration of 550 mg naproxen 2x daily + 300 mg rebamipide 2x daily + placebo of rabeprazole 1x daily over 7 days.
15898871|NCT03658473|Drug|550 mg naproxen + placebo + placebo|Oral administration of 550 mg naproxen 2x daily + placebo 2x daily + placebo of rabeprazole 1x daily over 7 days.
15898872|NCT03658460|Other|DNA sequencing|Targeted next generation sequencing and gene expression analysis with focus on immuno-oncology signatures
15898873|NCT03658447|Drug|Pembrolizumab|200mg Pembrolizumab given 3 weekly for upto 35 cycles
15898874|NCT03658447|Drug|177Lu-PSMA|6-weekly 177Lu-PSMA treatments for upto 6 cycles starting at 8.5GBq with administered radioactivity reduced by 0.5GBq for each cycle.
15898875|NCT03658434|Radiation|Palliative radiotherapy|Palliative Radiotherapy to Dominant Symptomatic Lesion in Patients With Hormone Refractory Prostate Cancer
15898876|NCT03658421|Drug|Dexmedetomidine|Dexmedetomidine added to lower concentration of ropivacaine for postoperative analgesia in FNB
15898877|NCT03658421|Procedure|ultrasound-guided femoral nerve block|ultrasound-guided femoral nerve block, a single bolous of 20 ml ropivacaine (concentration 0.2% for H group or 0.1% for L group) before surgery followed by continuous femoral nerve block using an infusion rate of ropivacaine 0.2% 5 ml/h for postoperative analgesia started right after surgery
15898878|NCT03658421|Device|intravenous patient-controlled analgesia pump with morphine|All subjects received intravenous patient-controlled analgesia (IV-PCA) pumps to measure additional morphine consumption, which included 50 mg morphine in 50 ml saline: bolus 2 mg; lock out time, 15 minutes.
15898879|NCT03658421|Procedure|Continuous femoral nerve block|All the continuous femoral nerve block infusion regimes in the pump were connected to CFNB catheter, which contained only ropivacaine with different concentrations (ropivacaine 0.1% for L group and LD group; ropivacaine 0.2% for H group, 5 ml/h).
15898880|NCT03658408|Drug|4-aminopyridine|Oral tablet of 2.5 mg given 4 times a day
15898881|NCT03658408|Drug|placebo|2.5 mg sugar pill given orally 4 times a day
15898882|NCT03658395|Procedure|Laparoscopic Sacrocolopopexy|The LSCP surgery involves pulling up the bladder, vagina, and rectum using a Y-shaped mesh attached to the lower back bone
15898883|NCT03658395|Procedure|Posterior repair|The PR surgery involves tightening the tissue between the rectum and vagina to reduce vaginal bulging during bowel movements.
15898884|NCT03658382|Other|Virtual Visit|Patients will receive the results of their genetic testing via a virtual visit.
15898887|NCT03658356|Other|Video instructions|Pregnant patient will watch her video explaining how to collect a urine sample for asymptomatic bacteriuria determination.
15898888|NCT03658343|Diagnostic Test|T2* Imaging|T2* imaging sequences for MRI
15898889|NCT03658330|Drug|Ketamine + Naltrexone|Subjects will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular naltrexone (380 mg) once a month (a total of 1 injection).
15898890|NCT03658317|Diagnostic Test|renal arterial resistive index|done by dupplex on renal arteries
15898891|NCT03658317|Diagnostic Test|uric acid level|serum sample for doing the test
15898892|NCT03658317|Diagnostic Test|serum urea and creatinine|serum samples for doing the test
15898893|NCT03658317|Diagnostic Test|24 hours urinary proteins|urine collected over 24 hours for doing the test
15898894|NCT03658317|Diagnostic Test|lipogram|serum sample for doing the test
15898895|NCT03658317|Diagnostic Test|HbA1c level|serum sample for doing the test
15898896|NCT03658317|Diagnostic Test|urine analysis|urine sample for doing the test
15898897|NCT03658317|Diagnostic Test|abdominal ultrasonography|done by the ultrasonography device
15898898|NCT03658304|Drug|Mitomycin c|All participants will receive a single 40 mg dose of mitomycin C intraoperatively during their scheduled nephroureterectomy. This single dose will be given through a catheter in the subject's bladder.
15898899|NCT03658291|Drug|Sanjin tablets|Sanjin tablets,3 pills /time, 4 times/ day, for 7 days+levofloxacin simulants,0.1g, po bid, for 7 days.
15898900|NCT03658291|Drug|Sanjin tablets simulants|levofloxacin ,0.1g, po bid, for 7 days+Sanjin tablets simulants,3 pills /time, 4 times/ day, for 7 days.
15898901|NCT03658291|Drug|Levofloxacin|Sanjin tablets,3 pills /time, 4 times/ day, for 7 days+levofloxacin,0.1g, po bid, for 7 days.
15898902|NCT03658278|Dietary Supplement|Juven|Nutritional supplement (Juven) will be consumed daily per manufacturer recommendations
15898903|NCT03658265|Other|7 days SIE plus 4 weeks PRE|"Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint.
~Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity."
15898904|NCT03658265|Other|7 days SIE plus 3 weeks PRE|"Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint.
~Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity."
15898905|NCT03658265|Other|3 days SIE plus 4 weeks PRE|"Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint.
~Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity."
15898906|NCT03658265|Other|3 days SIE plus 3 weeks PRE|"Shoulder isotonic exercise (SIE)：exercise methods for shortening and relaxing the muscles around the shoulder joint.
~Progressive resistance exercise (PRE)：A training method that gradually increases the resistance, which will increase the muscle capacity."
15898907|NCT03658252|Behavioral|Targeted education|Educational video developed by the hospital, addressing common misconceptions of topical steroids. A patient information leaflet on topical steroids
15898908|NCT03658252|Behavioral|Online disease specific forum|An invitation to join an online moderated disease specific social forum
15898909|NCT03658239|Other|Inversion|Inversions will be done while the subject is on the inversion table. The subject will be inverted to 135, 150 and 165 degrees. There inversion will not last longer than 3 minutes at a time. The inversion will be terminated if the subject's blood pressure drops below 50 mmHg diastolic or if the subject's blood pressure increases more than 50 mmHg systolic.
15898910|NCT03658226|Behavioral|Psychodynamic Interpersonal Therapy (PIT)|PIT is conversational model of psychotherapy; participants will receive 8 sessions of this therapy once weekly. The first session will be 2 hours and all remaining sessions will be 50 minutes.
15898911|NCT03658213|Drug|ZOLADEX 10.8 mg|10.8 mg depot for injection (equivalent to 10.8 mg goserelin)
15898912|NCT03658213|Drug|ZOLADEX 3.6mg|3.6 mg depot for injection (equivalent to 3.6 mg goserelin)
15898913|NCT03658200|Other|FAST start software delay|Scan delay will be determined by the FAST software bolus tracking technique. Before the start of bolus tracking (the time between start injection and start bolus tracking), a delay of 8 s is chosen. Bolus tracking threshold is set at 100 HU with a cycle time of 1.13 s and scan time of 0.25 s. After reaching the 100 HU threshold the FAST START software calculates the delay.
15898914|NCT03658200|Other|Manual bolus tracking delay|Scan delay will be determined by the standard bolus tracking technique. Before the start of bolus tracking (the time between start injection and start bolus tracking), a delay of 8 s is chosen. Bolus tracking threshold is set at 100 HU with a cycle time of 1.13 s and scan time of 0.25 s. After reaching the 100 HU threshold a delay of 6 s is chosen (table movement and breath hold command) and the scan starts.
15898915|NCT03658187|Dietary Supplement|Placebo|Beige-brown powder with speckles in clear enteric coated caplet with berry flavor liquid.
15898916|NCT03658187|Dietary Supplement|IP|Beige-brown powder with speckles in clear enteric coated caplet with berry flavor liquid.
15898917|NCT03658174|Dietary Supplement|Nitrate-rich beetroot juice|70mls of concentrated beetroot juice containing approximately 5-6 mmol of inorganic nitrate
15898918|NCT03658174|Dietary Supplement|Nitrate-free beetroot juice|70mls of concentrated beetroot juice that has been nitrate-depleted
15898919|NCT03658161|Behavioral|Communicating About Sexual Concerns and Dysfunction Effectively|The coaching intervention will include two parts: 1) initial coaching session, and 2) follow-up appointment to check in on use of the intervention strategies.
15898920|NCT03658148|Procedure|Cardiac Surgery with Cardiopulmonary Bypass|Cardiac Surgery with Cardiopulmonary Bypass
15898921|NCT03658135|Drug|BIIB092|BIIB092 is an investigational monoclonal antibody directed at tau protein
15898922|NCT03658135|Other|Placebo|Inactive ingredient
15898923|NCT03658122|Behavioral|Parent-Child Care|Parent-Child Care (PC-CARE) is a 6-week parenting intervention for children aged 1-10 years and their caregivers. This behavioral intervention involves weekly behavioral assessments, teaching of new skills, in-the-moment practice using the new skills, and discussion of how to incorporate skills at home.
15898924|NCT03658109|Drug|Lidocaine Bolus Infusion|Patients will undergo Lidocaine Bolus infusion.
15898925|NCT03658109|Procedure|QL block|Patients will undergo a posterior QL block pre-operatively
15898926|NCT03658109|Drug|Saline Bolus Infusion|Patients will undergo Saline Bolus infusion.
15898927|NCT03658109|Procedure|Simulated QL block|Patients will undergo a simulated posterior QL block pre-operatively.
15898928|NCT03658096|Device|pressure monitor ultrasound system|Patients and healthy volunteers will be tested sitting with the elbow flexed and the forearm pronated. The forearm of the examinee will be secured to the table. The hand will be positioned on an adjustable block such that the forearm will be in a horizontal position. At the distal radioulnar joint level, the transducer will be maintained perpendicular to the longitudinal axis of the ulna. The dorsal surface of the distal radius and the center of the ulnar head will be displayed on a monitor.To determine the same measurement level in each volunteer, the highest aspect of the ulnar head will be taken. The DRUJ motion during cyclic loading toward the palmar direction at the distal ulna will be recorded. The compression-release cycles will be applied with the pressure-monitor ultrasound system. The cycle will be set to 1.5Hz. The pressure in the palmar direction will be applied with different levels of transducer displacements, i.e. 1 mm, 2 mm, and 3 mm.
15898929|NCT03658083|Procedure|Thoracotomy|Open surgery
15898930|NCT03658083|Procedure|Robotic-assisted thoracic surgery|Minimally invasive surgery
15898931|NCT03658070|Drug|XY0206|Dosage form:Tablet;Single dose treatment:Take the drug once on day 1,each time 1 tablet. Multiple dose phase:Take the medicine once a day,1 tablet at a time.4 weeks of continuous medication is one course of treatment. After the first course of treatment, the subjects can continue to receive the experimental drug treatment until they meet the criteria for stopping treatment or determine the duration and interval of treatment according to the accumulated condition after multiple dose.
15898932|NCT03658057|Drug|Rocuronium|whether neuromuscular blockade by administering rocuronium is performed or not.
15898933|NCT03658044|Other|Participation in the internet forum|Active participation in the forum with encouragement to participate on a weekly basis
15898934|NCT03658044|Other|Placebo|No intervention performed. Patients are offered to read the open pages on the website
15898935|NCT03658031|Drug|Dapagliflozin 10mg|Dapagliflozin 10 mg administered each morning before breakfast
15898936|NCT03658018|Device|Intracept System Ablation|Radiofrequency ablation using Intracept System
15898937|NCT03658005|Other|Blood sample|3 blood samples, for a maximum of 60mL, will be taken at 0-3h, 3-6h and >6h, between two doses of ticagrelor (taken at 0 and 12 hours).
15898938|NCT03657979|Drug|Ropivacaine|TAP-block Ropivacaine 0.2% during 48 hours
15898939|NCT03657979|Drug|Placebo|TAP-block with placebo
15898940|NCT03657966|Biological|DCVAC/OvCa|activated dendritic cells (DCVAC/OvCa) for immune maintenance after chemotherapy
15898941|NCT03657966|Drug|Standard of Care Chemotherapy|either carboplatin and gemcitabine or carboplatin and paclitaxel followed by DCVAC/OvCa
15898942|NCT03657953|Other|surgical approach|
15898943|NCT03657940|Behavioral|VIVIFRAIL multicomponent exercise training program|The supervised multicomponent exercise training programme will be comprised of upper and lower body strengthening exercises, tailored to the individual's functional capacity, using dumbbells aiming for 2-3 sets of 10-15 repetitions at an intensity of 30-50% of 1Repetition Maximum ( combined with balance-training, flexibility and gait exercises that progressed in difficulty.
15898944|NCT03657927|Device|C-MAC videolaryngoscope|An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with C-MAC videolaryngoscope.
15898945|NCT03657927|Device|McGrath MAC videolaryngoscope|An intubating device that is used for endotracheal intubation. Endotracheal intubation was applied by anesthesiologist with McGrath MAC videolaryngoscope.
15898946|NCT03657914|Procedure|Single-hole inflatable mediastinal mirror|The radical resection of single-hole inflatable mediastinal mirror synchronization with laparoscopic esophageal carcinoma is new minimally invasive operation for esophageal carcinoma. All enrolled subjects will receive this operation for their ESCC.
15898947|NCT03657901|Behavioral|Music listening|Guided music listening for 30 minutes before sleep onset
15898948|NCT03657901|Behavioral|Slow breathing|Guided slow breathing for 30 minutes before sleep onset
15898949|NCT03657888|Behavioral|Family Club Denmark (FCD)|Participation in Family Club Denmark
15898950|NCT03657888|Other|Wait-list control|Participants on the waiting list
15898951|NCT03657862|Device|application of 38% silver diamine fluoride solution|SDF solution was painted onto the surface of the carious lesion of the tooth
15898952|NCT03657862|Other|application of a placebo (tonic water)|tonic water was painted onto the surface of the carious lesion of the tooth
15898953|NCT03657849|Device|EBUS TBNA|All patients undergo EBUS TBNA with two needle sizes
15898954|NCT03657836|Dietary Supplement|Sublimated mare milk supplement|The dietary supplement consisting of sublimated mare milk packed in single-dose sachet.
15898955|NCT03657836|Drug|Standard antibiotic therapy|Patients will be given standard therapy antibiotics cefuroxime and ceftriaxone for up to 7 days period.
15898956|NCT03657810|Drug|CL-108 5 mg|hydrocodone 5 mg/APAP 325 mg/promethazine 12.5 mg
15898957|NCT03657810|Drug|Norco|hydrocodone 5 mg/APAP 325 mg
15898958|NCT03657810|Drug|Placebo|Placebo matching CL-108
15898959|NCT03657797|Drug|NCX 470|NCX 470 Ophthalmic Solution
15898960|NCT03657797|Drug|Latanoprost 0.005%|Latanoprost 0.005% Ophthalmic Solution
15898961|NCT03657784|Drug|P03277|Single intravenous bolus injection at 0.1 mmol/kg body weight at a rate of 2 mL/second
15898962|NCT03657771|Other|DED|DED: Diet eliminating dairy
15898963|NCT03657771|Other|FREE|FREE: Diet eliminating dairy and food additives
15898964|NCT03657758|Drug|EPA and rosuvastatin|To take EPA (1800mg/day) and high dose rosuvastatin (10mg/day) for ９ months.
15898965|NCT03657758|Drug|High dose rosuvastatin|To take high dose rosuvastatin (10mg/day) for ９ months.
15898966|NCT03657745|Device|Combination of 40Hz light and cognitive therapy (ALZLIFE)|Combination of 40Hz light and cognitive therapy delivered by iPad application ALZLIFE
15898967|NCT03657719|Biological|GC3114|High-dose Quadrivalent influenza vaccine
15898968|NCT03657719|Biological|GCFLU Quadrivalent|Quadrivalent influenza vaccine
15898969|NCT03657706|Procedure|group A (Tunnel procedure with subepithelial connective tissue graft (sCTG)|Subepithelial connective tissue graft (autogenous graft) will be harvested from the palate by Single incision technique to be used with the prepared tunnel to treating gingival recession
15918503|NCT03509012|Drug|Pemetrexed|IV
15898970|NCT03657706|Procedure|group B (Tunnel procedure with modified free gingival graft (mFGG))|modified free gingival graft (autogenous graft) will be harvested from the palate and will be used with the prepared tunnel to be used in treating gingival recession
15898971|NCT03657693|Diagnostic Test|NICU MRI|MRI device that is not FDA approved.
15898972|NCT03657693|Diagnostic Test|Polysomnography|Polysomnography to better determine obstruction index in the airway.
15898973|NCT03657680|Other|Evaluation|The volunteers were submitted to an evaluation of pain, range of motion, muscular strength and functional capacity.
15898974|NCT03657667|Procedure|Ureteroscopy|Endoscopic removal of kidney stones
15898975|NCT03657654|Other|No intervention: observational only|No intervention: observational only
15898976|NCT03657641|Biological|Pembrolizumab|Given IV
15898977|NCT03657641|Drug|Regorafenib|Given PO
15898978|NCT03657628|Other|Exercise Intervention|Strength training and moderate-intensity, aerobic exercise
15898979|NCT03657615|Device|hearing aid fitting|All patients were fitted bilaterally with hearing aids for hearing loss compensation. . Apart from different HAs used, device selection followed strict criteria to fit hearing loss demands, patient profile, resources and algorithms recommended for tinnitus patients.
15898980|NCT03657602|Drug|Kyleena Intrauterine System|Participant will be randomly allocated to this intervention
15898981|NCT03657602|Drug|Mirena Intrauterine System|Participant will be randomly allocated to this intervention
15898982|NCT03657576|Biological|C134|C134 is a virus that was created from an oncolytic Herpes Simplex Virus (oHSV) known to infect and kill tumor cells. The Investigators have made changes to the original virus to make C134. It efficiently infects tumor cells (not normal healthy cells) and induces an immune response to fight the cancer as well.
15898983|NCT03657563|Other|Positive psychological intervention|"Participants in the intervention group are required to record three good things every night before sleeping for five days a week using WeChat. Such things could be ordinary, minor or important.
~WeChat is a common communication tool used in China, just like Facebook, basic messages could be sent individually and posting pictures or texts is also available."
15898984|NCT03657550|Drug|Levamlodipine, Amlodipine|In Part 1, this group of subjects were treated with a single dose of 5 mg levamlodipine maleate tablets (Test Product), then crossed over to receive a single dose of 10 mg Amlodipine Besylate Tablet NORVASC® (Reference Product) under fasted conditions. After a wash-out period for 14-days, all subjects were rolled over to Part 2 where they received a single dose of 5 mg levamlodipine maleate tablets under a high-fat/high-calorie meal to assess food effect.
15898985|NCT03657550|Drug|Amlodipine, Levamlodipine|In Part 1, this group of subjects were treated with a single dose of 10 mg Amlodipine Besylate Tablet NORVASC® (Reference Product), and then crossed over to receive a single dose of 5 mg levamlodipine maleate tablets (Test Product) under fasted conditions. After a wash-out period for 14-days, all subjects were rolled over to Part 2 where they received a single dose of 5 mg levamlodipine maleate tablets under a high-fat/high-calorie meal to assess food effect.
15898986|NCT03657537|Drug|Ketone infusion|β-hydroxybutyrate is infused intravenously.
15898987|NCT03657537|Drug|Saline infusion|saline is infused intravenously.
15898988|NCT03657524|Other|echocardiography|Speckle tracking echocardiography
15898989|NCT03657511|Behavioral|Educational Interventions to Promote Tobacco Cessation|"Women receiving a screening mammogram at KCI downtown and McLaren Macomb, will be given a self-administered questionnaire at check-in.
~Women who indicate they are current smokers are eligible for the study. After the screening mammogram is complete, eligible women will be consented. Educational materials will be provided to the participant at that time. The materials provided outline evidence-based approaches to smoking cessation and include contact information for local resources including cessation support groups, Michigan Tobacco Quitline, American Cancer Society's Guide to Quitting Smoking, Quitnet, Smokfree.gov and Become An Ex. The participant will be contacted by telephone approximately 12 weeks later to determine if she is currently smoking or had quit in the last 12 weeks."
15898990|NCT03657498|Procedure|Combined orthodontic-orthognathic treatment|combined treatment including orthodontics and orthognathic surgery
15898991|NCT03657498|Procedure|Standard orthodontic treatment|treatment with standard orthodontic procedures
15898992|NCT03657485|Dietary Supplement|containing Bifidobacterium breve PB04, Lactobacillus rhamnosus KL53A|we supplemented the probiotic orally during the first hour of life and after 12 hours in mother's milk or formula (the total amount of the probiotic was 2 x 10 6 CFU bacteria).
15898993|NCT03657472|Drug|CJ-30061|Test: CJ-30061(Fixed-dose combination drug containing Amlodipine 5mg/Valsartan 160mg/Atorvastatin 20mg)
15898994|NCT03657472|Drug|Exforge® 5/160mg & Lipitor® 20mg|Reference: Co-administration of Exforge® tab 5/160mg and Lipitor® tab 20mg
15898995|NCT03657459|Other|Danger Signs of Heart Failure Videos|Short (under 3 minutes each) videos on (a) recognition of dyspnea, fatigue and edema and (b) self-management of each (based on diet, fluid management and activities)
15898996|NCT03657446|Drug|Clazosentan|Continuous i.v. infusion of 20 mg/h or 60 mg/h of clazosentan for 3 h
15898997|NCT03657446|Drug|Placebo|Matching placebo infusion
15898998|NCT03657446|Drug|Moxifloxacin|Film-coated tablet containing 400 mg moxifloxacin
15898999|NCT03657433|Dietary Supplement|Ferrous sulfate 325mg|Oral tablets supplied for home use
15899000|NCT03657433|Drug|Ferumoxytol|Ferumoxytol will be administered in two infusions, one week apart
15899001|NCT03657420|Drug|ABI-009|ABI-009 is an mTOR inhibitor. This pathway is believed to be overactive in multiple myeloma.
15899002|NCT03657420|Drug|Pomalidomide|Pomalidomide is an immunomodulatory agent and believed to work by affecting the growth signals that keep cancer cells alive.
15899003|NCT03657420|Drug|Dexamethasone|Dexamethasone is a steroid which is believed to kill cancer cells
15899004|NCT03657407|Drug|Belladonna Opium|Belladonna Opium 16.2-60mg rectal suppository
15899005|NCT03657407|Drug|Glycerin Suppository|Glycerine rectal suppository
15899006|NCT03657394|Other|Umbilical cord milking|At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 1--15 seconds.
15899197|NCT03655873|Drug|HEC30654AcOH capsule|"single ascending-dose study: 5-、10-、15-、30-、60-、90-、120mg HEC30654AcOH capsule in day1.
~Multiple ascending-dose study:
~15-、30-、60mgHEC30654AcOH capsule in day1-day7，2 times everyday."
15899007|NCT03657381|Drug|Recombinant Humanized Anti-PD-1 Monoclonal Antibody Injection|Biological: F520 single-dose:0.2mg/kg, 1.0mg/kg, 3.0mg/kg, 200mg/times, 10mg/kg; multiple dosing: 1mg/kg, 3mg/kg, 200mg/times, 10mg/kg, treat every 2 weeks; multiple dosing: 3mg/kg, 200mg/times, treat every 3 weeks.
15899008|NCT03657368|Procedure|Low tidal Volume|Tidal volume = 6 ml/kg predicted body weight
15899009|NCT03657368|Procedure|High tidal Volume|Tidal volume = 10 ml/kg predicted body weight
15899010|NCT03657368|Procedure|Low PEEP|PEEP = 5 cm H2O
15899011|NCT03657368|Procedure|High PEEP|PEEP = 8 cm H2O
15899012|NCT03657355|Drug|ACT-541468|ACT-541468 will be administered as 50 mg tablets for oral use.
15899013|NCT03657355|Drug|Suvorexant|Suvorexant will be administered as 15 mg over-encapsulated tablets for oral use.
15899014|NCT03657355|Drug|Zolpidem|Zolpidem will be administered as 10 mg over-encapsulated tablets for oral use.
15899015|NCT03657355|Drug|Placebo|Matching-placebo will be used.
15899016|NCT03657342|Drug|Liposomal Cyclosporine A|delivered via the PARI eFlow® Device
15899017|NCT03657329|Diagnostic Test|Dreem|Dreem Band to be worn by each participant while undergoing in-lab sleep study with PSG. Pursuant to the physician-ordered diagnostic study, clinical staff may determine a split-night study with CPAP to be appropriate for any participant, simultaneous with the PSG and Dreem.
15899018|NCT03657316|Behavioral|nutrition education|"The content of the three days workshop:Healthy diet, Diet-related health risks and diseases, Physical activity The sustained multi-component program will be based on The three days nutritional and physical education workshop Enhanced physical education Involvement of the morning broadcast in provision of messages for students about nutrition and physical activity Brochure including key messages about diet and physical activity will be designed and sent to parents of the intervention classes of students A monthly telephone call or a text message will be sent to the parents to remind them about the commitment to the dietary health practices.
~Message to school administration to prevent selling of soft drinks and to sell healthy food A monthly session for three months will be held to remind the students with the messages"
15899019|NCT03657303|Device|Magnetic resonance imaging (MRI)|Participants will undergo an initial (baseline) MR examination, followed by repeat MR examinations at approximately 1 month and 1 year following the baseline examination.
15899020|NCT03657290|Drug|vadadustat|Vadadustat Tablets
15899021|NCT03657277|Device|Micropatch|Each micropatch contains 50 tiny projections (800 um in length)
15899022|NCT03657264|Drug|P03277 0.1 mmol/kg|Single intravenous bolus injection at 2 mL/sec
15899023|NCT03657264|Drug|Moxifloxacin 400mg|One tablet per os
15899024|NCT03657264|Drug|NaCl 0.9%|Single intravenous bolus injection at 2 mL/sec
15899025|NCT03657264|Drug|P03277 0.3 mmol/kg|Single intravenous bolus injection at 2 mL/sec
15899026|NCT03657251|Genetic|liquid biopsy|Participants will be asked to provide up to a maximum total 40 mL of blood for all of the required sample collection. Peripheral blood will be collected from patients who consent to the protocol. These samples will be obtained at a time scheduled by the participant with the phlebotomy service provider, and will be collected at the participant's home. Patient peripheral blood samples can be obtained at diagnosis or at any time in follow up.
15899027|NCT03657238|Drug|RD01|single S.C. dose of RD01 for subjects in test group
15899028|NCT03657238|Drug|Placebo|single S.C. dose of placebo for subjects in placebo group
15899029|NCT03657225|Device|Utilization of the mini CPB circuit|Comparison of the mini CPB circuit to conventional circuit
15899030|NCT03657225|Drug|Utilization of the conventional circuit|Comparison of the mini CPB circuit to conventional circuit
15899031|NCT03657212|Drug|Zolpidem|The research involves oral administration of zolpidem (ZOL) or placebo during sleep with EEG recording. This study will employ a within-subject, crossover design, in which every subject experiences each of the following study conditions: Nap/5mg, Nap/placebo, plus an adaptation nap to be scheduled one week prior to the first experimental day. One condition will be tested per week, with condition order counterbalanced. Each subject will have 2 visits (plus an adaptation nap), each separated by 5-7 days (although this may be extended based on participant availability) to ensure that the drug is completely eliminated from the body. The order of drug conditions will be randomized and counterbalanced.
15899032|NCT03657199|Diagnostic Test|Cardiac computed tomography|Routine computed tomography of the heart before discharge
15899033|NCT03657186|Dietary Supplement|ProbioSatys™|One capsule, twice a day, is to be orally taken with 100 mL of water during each breakfast and lunch (approx. 5 minutes after starting eating), total 2 capsules per day.
15899034|NCT03657186|Other|Placebo|One capsule, twice a day, is to be orally taken with 100 mL of water during each breakfast and lunch (approx. 5 minutes after starting eating), total 2 capsules per day.
15899035|NCT03657160|Drug|Vedolizumab|Vedolizumab intravenous infusion.
15899036|NCT03657160|Drug|Vedolizumab Placebo|Vedolizumab placebo-matching intravenous infusion.
15899037|NCT03657147|Behavioral|Educational Video and Question Prompt List|A short educational video will be presented on an iPad about the importance of encouraging patients to ask questions and to be involved during glaucoma visits to improve self-management skills. A question prompt list will also be completed where participants check questions of interest to ask the provider.
15899038|NCT03657134|Diagnostic Test|CoVa-2 Monitoring System|Upon completion of EP procedure, CoVa-2 monitoring system will be applied until discharge. Data from the sensor will be sent to the Gateway and Cloud-based system and analyzed retrospectively.
15899039|NCT03657108|Radiation|Civasheet 60 Gy|implantable proposed doses of Civasheet are 60 Gy
15899040|NCT03657108|Radiation|Civasheet 75 Gy|implantable proposed doses of Civasheet are 75 Gy
15899041|NCT03657108|Radiation|Adjuvant external beam radiation therapy|45 Gy in 25 fractions
15899042|NCT03657095|Drug|Esuberaprost|Sodium tablets
15899043|NCT03657095|Drug|Placebo|Placebo tablets, which are identical in size and appearance to those containing Esuberaprost.
15899044|NCT03657082|Device|PEP-10|Bottle PEP with a water level of 10 cmH2O
15899045|NCT03657082|Device|PEP-1|Bottle PEP with a water level of 1 cmH2O
15899046|NCT03657069|Device|Blossom|Undergo Implant Breast Reconstruction (IBR) with the Blossom Smart Expander Technology
15899047|NCT03657069|Other|Breast-Q -Reconstruction module (preoperative) version 2.0 satisfaction with breasts questionnaire|Ancillary studies
15899324|NCT03654833|Drug|pembrolizumab & bemcentinib|PD1 checkpoint inhibitor, AXL inhibitor
15899048|NCT03657056|Device|BX Pulsar 1002|"LIFUP will be administered to the temporal region on the side to undergo surgery, within the focus producing seizures. The ultrasound will be focused on the highest activity area within the temporal lobe. Functional MRI of the brain will be obtained throughout the LIFUP session.
~After the participant is fitted with the transducer they will be placed in the MRI machine and undergo a series of scans. After placing the transducer over the anterior tip of the temporal lobe the participant will undergo fMRI BOLD scans with LIFUP excitation (from (Lee et al., 2015): Tone Burst Duration = 2ms and Pulse Repetition Frequency = 250Hz) at four levels of intensity (720mW/cm2, 1440mW/cm2, 2880mW/cm2 and 5760mW/cm2). Before increasing the intensity, the transducer will be moved approximately 5mm posterior. After the last excitation scan the LIFUP parameters will be changed to inhibitory parameters (from (Yoo et al., 2011): Tone Burst Duration = 0.5ms and Pulse Repetition Frequency = 100Hz)."
15899049|NCT03657043|Drug|tisotumab vedotin|Intravenous (IV) infusion
15899050|NCT03657030|Drug|CVN424|SAD / MAD
15899051|NCT03657030|Drug|Placebo|Placebo
15899052|NCT03657017|Diagnostic Test|PET/MR|Performed on a hybrid PET/MR scanner before treatment start (N = 150). Among those patients, 10 patients are examined with PET/MR in the completion of neoadjuvant chemotherapy and a follow-up scan three months after the completion of radiotherapy.
15899053|NCT03656991|Other|Bicycle intervention|
15899054|NCT03656978|Behavioral|dynamic|Use the according methods in dynamic arm descriptions.
15899055|NCT03656978|Behavioral|Regular-triangle|Use the according methods in regular-triangle arm descriptions.
15899056|NCT03656965|Drug|Acyclovir 800 MG|Acyclovir tablets 800 mg per day during the whole course of treatment Or Placebo.
15899057|NCT03656965|Combination Product|Radiotherapy and chemotherapy|Concurrent chemoradiotherapy which consisted of Cisplatin 40 mg/m2 weekly or 100mg/m2 every 3 weeks with IMRT 70Gy/35 fractions.
15899058|NCT03656952|Drug|PF-06700841|a single oral dose of 200 mg PF-06700841
15899059|NCT03656952|Drug|Placebo|Placebo matching PF-06700841
15899060|NCT03656952|Drug|moxifloxacin|a single oral dose of 400 mg moxifloxacin
15899061|NCT03656926|Drug|Liposomal Cyclosporine A|delivered via the PARI eFlow® Device
15899062|NCT03656913|Diagnostic Test|Extremely low dose CT|Patients undergoing clinically indicated CT will also receive the extremely low dose CT
15899063|NCT03656900|Device|rTMS BA9/BA46|10 sessions of low-frequency repeated transcranial magnetic stimulation over two weeks on cortical area 9, then 4 weeks wash-out, then 10 sessions of low-frequency repeated transcranial magnetic stimulation repeated low frequency over two weeks on cortical area 46.
15899064|NCT03656900|Device|rTMS BA46/BA9|10 sessions of low-frequency repeated transcranial magnetic stimulation over two weeks on cortical area 46, then 4 weeks wash-out, then 10 sessions of low-frequency repeated transcranial magnetic stimulation repeated low frequency over two weeks on cortical area 9.
15899065|NCT03656900|Radiation|brain MRI|T1 weighted full-head high-resolution MRI with 1 mm seam cuts and sagittal orientation.
15899066|NCT03656900|Other|Medical evaluation|complete evaluation with 6 scales (HDRS, MADRS, Beck, CGI, COVI, UKU)
15899067|NCT03656900|Other|Psychological assessment|Subjective Life Profile Assessment (SLPA) and Helping Alliance Assessment
15899068|NCT03656887|Device|Continuous interstitial glucose sensor|Installing and removing the sensor
15899069|NCT03656887|Other|Sensor Scan|Scan of the sensor, using the Freestyle Pro free version reader, at installation then before removal after 14 days.
15899070|NCT03656874|Other|Clinical Decision Support|The clinical decision support will provide clinical practice guideline-supported, evidence-based, and personalized scripts that are tailored based on patients' self-reported smoking attributes to deliver interventions consistent with the standard of care
15899071|NCT03656861|Other|Physical load|The impact of training on cardiac structure and function depends on the type, intensity and duration of the activity, as well as previous physical activity engagement, genetics and gender type. More knowledge about cardiac pathophysiologic training adaptation is needed.
15899072|NCT03656848|Diagnostic Test|QFR|QFR is a novel method for evaluating the functional significance of coronary stenosis by calculation of the pressure drop in the vessel based on two angiographic projections.
15899073|NCT03656848|Diagnostic Test|Angiography|Coronary angiography is a procedure that uses contrast under x-ray pictures to detect stenosis in the coronary arteries
15899074|NCT03656835|Procedure|Molecular Nanotechnology|Undergo ILN biochip testing
15899075|NCT03656822|Diagnostic Test|Routine CT|CAT (Computerized Axial Tomography) scan, is a noninvasive X-ray test that is used to diagnose a variety of medical conditions.
15899076|NCT03656822|Diagnostic Test|Routine imaging CT with a 3D printed model|CAT (Computerized Axial Tomography) scan, is a noninvasive X-ray test that is used to diagnose a variety of medical conditions + 3D Printed Model
15899077|NCT03656822|Diagnostic Test|Routine imaging MRI with a 3D printed model|will measure post-operative lesion volume as visualized on the post-operative MRI + 3D Printed Model
15899078|NCT03656822|Diagnostic Test|Routine MRI|will measure post-operative lesion volume as visualized on the post-operative MRI
15899079|NCT03656822|Diagnostic Test|Routine imaging CT with a VR model|CAT (Computerized Axial Tomography) scan, is a noninvasive X-ray test that is used to diagnose a variety of medical conditions + VR Model
15899080|NCT03656822|Diagnostic Test|Routine imaging MRI with a VR model|will measure post-operative lesion volume as visualized on the post-operative MRI + VR Model
15899081|NCT03656796|Other|Treadmill training with auditory cues|Participants should walk on the treadmill according to the rhythmic auditory cues (110% step frequency) for 30 min
15899082|NCT03656796|Other|Treadmill training without auditory cues|Participants should walk in comfortable speed on the treadmill for 30 min.
15899083|NCT03656783|Drug|Biktarvy|Open-label, multicenter, single-arm study to Evaluate the Safety and Efficacy of Switching from Regimens Consisting of Abacavir/Lamivudine/Dolutegravir (ABC/3TC/DTG) to the Bictegravir/ Emtricitabine/Tenofovir Alafenamide (B/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV-Infected Adult Subjects
15899084|NCT03656770|Other|Survey questionnaire|Each version of the questionnaire portrays a young Ugandan woman with different profiles of illness severity, treatment, and treatment response.
15899085|NCT03656744|Drug|HTD1801|HTD1801 tablets, 250mg
15899086|NCT03656744|Drug|Placebo|tablets manufactured to mimic HTD1801 tablets
15918507|NCT03509012|Drug|Cisplatin (dose level 1)|IV
15899087|NCT03656731|Other|Breast cancer exercise intervention|"The exercise-based intervention is comprised of:
~Supervised and group-based exercise training at the hospital setting two times a week. Each session will last approximately 60 minutes.The program consists of warm-up, exercises for balance and flexibility, progressive resistance training (seven resistance training exercises targeting the large muscle groups), and stretching and relaxation.
~Home-based walking with activity tracker assessment. Evaluation and goal-setting in relation to activity (step counts) will be conducted once weekly.
~Serving of a protein supplement (protein drink or bar) after each supervised training session."
15899088|NCT03656718|Biological|nivolumab|(Subcutaneous) Specified dose on specified days
15899089|NCT03656718|Drug|rHuPH20|Specified dose on specified days Permeation enhancer
15899090|NCT03656718|Biological|nivolumab|(IV) Specified Dose on Specified Days
15899091|NCT03656705|Biological|CCCR-NK92 cells|CCCR-NK92 cells will be administered intravenously over 1h. The starting dose of CCCR-NK92 cells will be 1×10e7-1×10e8,twice a week. The first evaluation of the efficacy after 3 weeks of treatment.
15899092|NCT03656692|Drug|Acthar Gel|Acthar gel for subcutaneous injection 80 units per mL (40 units per 0.5 mL)
15899093|NCT03656679|Procedure|Pectoralis Blockade (PECs)|Ten milliliters of 0.25% bupivacaine with 2.5 mcg/ml epinephrine will be deposited between the pectoralis major and minor (PECs I) and 20 cc of 0.25% bupivacaine with 2.5mcg/ml epinephrine deposited between the pectoralis minor and serratus anterior muscle.
15899094|NCT03656679|Procedure|Paravertebral Blockade|10cc of 0.25% bupivacaine with 2.5 mcg/ml epinephrine will be deposited at two levels (T3 and T5) per side while in the sitting position.
15899095|NCT03656666|Drug|Apremilast|Apremilast oral tablets
15899096|NCT03656666|Drug|Placebo|Placebo oral tablets
15899097|NCT03656653|Behavioral|Mental Imagery for Craving Reduction|a behavioural mental imagery intervention where participants are asked to generate specific mental images to reduce cue-induced craving for cocaine use disorder
15899098|NCT03656640|Drug|Gammanorm|Patients already receiving Gammanorm will be observed over the course of 2 years every 3 months. Gammanorm will be given standard of care.
15899099|NCT03656627|Drug|Nivolumab|"Nivolumab will be given as an IV infusion every two weeks, in an outpatient setting. One cycle is a 28-day period, with Nivolumab given on days 1 and 15 of a 28-day cycle.
~For each cohort, all patients will be dosed at 240 mg IV. There will be no dose de-escalation or escalation from this dose level."
15899100|NCT03656614|Drug|Sugammadex|"At the end of surgical procedure at a depth of neuromuscular blockade at the reappearance of train-of-four 0.3, single intravenous injection of either :
~Sugammadex 0.125 mg/kg (sugammadex 0.125) Sugammadex 0.25 mg/kg (sugammadex 0.25) Sugammadex 0.5 mg/kg (sugammadex 0.5) Sugammadex 1.0 mg/kg (sugammadex 1.0) Sugammadex 2.0 mg/kg (sugammadex 2.0)"
15899101|NCT03656614|Drug|Neostigmine|"At the end of surgical procedure at a depth of neuromuscular blockade at the reappearance of train-of-four 0.3, single intravenous injection of either :
~Neostigmine 10 µg/kg (Neostigmine 10) Neostigmine 25 µg/kg (Neostigmine 25) Neostigmine 40 µg/kg (Neostigmine 40) Neostigmine 55 µg/kg (Neostigmine 55) Neostigmine 70 µg/kg (Neostigmine 70)
~Atropine will be administered with Neostigmine at a half dose of Neostigmine administered through an intravenous line with brisk flow."
15899102|NCT03656614|Drug|Saline 0.9%|At the end of surgical procedure at a depth of neuromuscular blockade at the reappearance of train-of-four 0.3, single intravenous injection of saline 0.9%.
15899103|NCT03656601|Diagnostic Test|3D pelvic ultrasound|3D pelvic ultrasound by transperineal route
15899104|NCT03656588|Drug|a. Standard iodine scrub, 3% hydrogen peroxide prep, follow by ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol|a. Standard iodine scrub, 3% hydrogen peroxide prep, follow by ChloraPrep (2% chlorhexidine gluconate and 70% isopropyl alcohol
15899105|NCT03656588|Drug|Iodine scrub and ChloraPrep alone|Iodine scrub and ChloraPrep alone
15899106|NCT03656575|Biological|synovial fluid biomarker concentrations|Synovial fluid samples will be obtained pre-injection, Post Injection 3 Weeks, Post Injection 6 Weeks, Post Injection 9 Weeks, Post Injection 3 Months, Post Injection 6 Months, Post Injection phone call at 1 Year
15899107|NCT03656562|Drug|VAY736|Powder for solution for injection
15899108|NCT03656562|Drug|VAY736 Placebo|Solution for injection
15899109|NCT03656562|Drug|CFZ533|Concentrate for solution for infusion
15899110|NCT03656562|Drug|CFZ533 Placebo|Solution for infusion
15899111|NCT03656549|Drug|Pemetrexed|patients will be treated with pemetrexed, with dosing based on renal function. As a safety measure, the first dose will be calculated to 50% exposure. After administration, safety and pharmacokinetics are assessed. If tolerated well, dose escalation to reach 100% exposure is performed, including assessment of safety and pharmacokinetics.
15899112|NCT03656536|Drug|Pemigatinib|Pemigatinib at the protocol-defined dose administered orally once daily as continuous therapy schedule (a cycle is 3 weeks).
15899113|NCT03656536|Drug|Gemcitabine|Gemcitabine 1000 mg/m^2 administered as an intravenous infusion on Days 1 and 8 of every 3-week cycle for up to 8 cycles.
15899114|NCT03656536|Drug|Cisplatin|Cisplatin 25 mg/m^2 administered as an intravenous infusion on Days 1 and 8 of every 3-week cycle for up to 8 cycles.
15899115|NCT03656523|Other|Acute coronary syndrome and PCI and AF|Patient with ACS and ACS treated with PCI
15899118|NCT03656497|Other|Observational|No intervention is conducted as the study aim is to explore the link between pheno- and genetype of trigeminal neuralgia
15899119|NCT03656484|Drug|Tetracycline-Metronidazole (TM) group|Following mechanical debridement (scaling and root planning) the above-mentioned paste will be topically administrated in the periodontal pocket of affected teeth once a day, for 30 consecutive days.
15899120|NCT03656484|Drug|TM-Melatonin-Hyaluronic acid (TM-MHa) group|Following mechanical debridement (scaling and root planning) the above-mentioned paste will be topically administrated in the periodontal pocket of affected teeth once a day, for 30 consecutive days.
15899121|NCT03656471|Device|clear aligners or fixed appliances|Patients choose clear aligners or fixed appliances to treat their malocclusions
15899122|NCT03656458|Other|Warm Up|10 low jumps 5 Illiopoase Stretches 5 L/L Abductor Stretches 10 Trunk rotations 10 Should Circumduction Clock wise/Counter clockwise 10 Cervical Rotations Clockwise/Counter Clockwise
15899123|NCT03656458|Other|Conventional Balance Training|"Internal Protuberances:
~Looking up/Looking down/looking over the shoulder (Rt. /Lt.) 10 Reps Each
~Looking behind over the shoulder (Rt. /Lt.)10 Reps
~Looking Up with overhead Upper Limb Flexion. 5 Reps
~Reaching out of Base of support (Rt. /Lt. / midline Cross) 10 Reps Each
~Side to Side weight Shifting 10 Reps
~Standing on toes/Heels 10 Reps each
~External Protuberance:
~Tuck forward/ Backward/ Sideways(Rt. /Lt.) 10 reps Each
~Bosu Ball Training"
15899124|NCT03656458|Other|Biodex Balance Training|Biodex Balance Training Using Biodex Balance System SD
15899125|NCT03656445|Drug|Tranexamic Acid|1 dose of IV TXA (15mg/kg) in 100-ml normal saline, 10 minutes before incision, administered during the induction of the anesthesia
15899126|NCT03656445|Drug|Tranexamic Acid|1 dose of IV TXA (15mg/kg) in 100-ml normal saline, 10 minutes before incision and an additional dose of IV TXA (15mg/kg) in 100-ml normal saline 3 hours after skin incision
15899127|NCT03656445|Drug|Tranexamic Acid|1 dose of IV TXA (15mg/kg) in 100-ml normal saline, before incision and two additional doses of IV TXA (15mg/kg) in 100-ml normal saline 3 and 6 hours after skin incision respectivel
15899128|NCT03656432|Drug|CPP-ACP paste|The complex CPP-ACP derived from a milk protein called casein. CPP-ACP represents an alternative remineralizing agent that prevents the early demineralization, it is capable of stabilizing calcium phosphate, maintaining the supersaturation of these ions in the oral environment by binding with them and transport them in the form of amorphous calcium phosphate. They can enhance remineralization, decrease demineralization or even both in an acid challenge to teeth surfaces.
15899129|NCT03656419|Procedure|photodynamic therapy|aPDT with methylene blue and red led irradiation.
15899130|NCT03656419|Procedure|Tongue scraper|Tongue scraper 10 times from de back to the top.
15899131|NCT03656406|Behavioral|Lateral decubitus positioning|After the DLT intubation, the patient is placed in lateral decubitus position
15899132|NCT03656406|Device|Cuff-manometer|The pressure of the bronchial cuff should be measured with cuff-manometer in supine position, and then measurement should be repeated after lateral positioning.
15899133|NCT03656393|Drug|Gefitinib|Gefitinib (250 mg, orally, every day) for 56 days
15899134|NCT03656393|Drug|Vinorelbine|Vinorelbine (60 mg/m2, orally, Once every three weeks) for 6 weeks
15899135|NCT03656393|Drug|Carboplatin|Carboplatin (AUC5, intravenously drip, once a week) for 6 weeks
15899136|NCT03656380|Drug|Mepolizumab 300 mg|Mepolizumab 300 mg subcutaneous injection
15899137|NCT03656380|Drug|Mepolizumab 100 mg|Mepolizumab 100 mg subcutaneous injection
15899138|NCT03656380|Other|Placebo|Saline subcutaneous injection
15899139|NCT03656367|Dietary Supplement|Cheddar cheese|The reference product is a commercial matured cheddar cheese
15899140|NCT03656367|Dietary Supplement|Blended and homogenized cheddar cheese|A blended and homogenized cheddar cheese (a spread) which, compared to the reference, has a minimal protein network and has smaller fat droplet
15899141|NCT03656367|Dietary Supplement|An analog milk|An anolog milk (i.e. milk with a cheese-like nutritional composition) which, compared to the reference, does not contain a protein network
15899142|NCT03656367|Dietary Supplement|An analog cheese|This analog cheese (a gel/yoghurt) is produced from the analog milk which, compared to the reference, has a protein network, however it is a network that differs from the reference
15899143|NCT03656354|Device|Seismocardiography|Seismocardiography recording
15899144|NCT03656341|Behavioral|2 Feet 4 Life|2 Feet 4 Life consists of four weekly group intervention sessions of one hour each. 2 Feet 4 Life includes self-management teaching, interactive lecture, and group activities, including instruction and demonstration of routine foot care. The program includes education regarding appropriate footwear and how to find it, evidenced based practices on hygiene, skin care and self-care of the lower extremities, nail trimming and filing, and care of common foot problems.
15899145|NCT03656328|Dietary Supplement|Lactobacillus Reuteri 4659|supplementation with L. reuteri 4659 twice a day for 10 days during the standard antibiotic therapy
15899146|NCT03656328|Dietary Supplement|Placebo|supplementation with a Placebo capsule twice a day for 10 days during the standard antibiotic therapy
15899147|NCT03656315|Other|Airway Assessment|All patients recruited to this study will have an ultrasound of their cricothyroid membrane
15899148|NCT03656289|Drug|Etonogestrel 68Mg Implant|Participants will have an etonogestral contraceptive implant (NEXPLANON) placed sub-dermally just under the skin at the inner side of the non-dominant upper arm.
15899149|NCT03656276|Behavioral|Tool to improve Participation In Clinical Trials (ToPIC)|The Tool to improve Participation In Clinical Trials (ToPIC) is a communication tool to facilitate clinical trial decision making conversations between oncologists and patients.
15899150|NCT03656263|Diagnostic Test|Doppler assessment of portal vein flow|Doppler assessment of portal vein flow using peri-operative trans-esophageal echography before and after cardiopulmonary bypass.
15899151|NCT03656250|Diagnostic Test|PET/CT scans|(approximately 18 mSv/scan) and perform maximum two additional PET/MR scans; one immediately after the first stage of treatment and another one immediately after the second stage if the 3-month chemotherapy is given).
15899152|NCT03656237|Other|Usual Training|Training in a classroom setting of health care providers
15899153|NCT03656237|Other|Audits + LDHF Training|Clinical audits followed by case-based low-dose high-frequency training
15899154|NCT03656224|Other|Survey Administration|Ancillary studies
15899155|NCT03656211|Other|Telephone interview|"Patients are contacted by telephone to know the history of the disease since the diagnosis of UAVM and the impact of management on fertility.
~All medical data related to the care and necessary for the study are collected from the medical file the participation of the patients is limited to a telephone interview."
15899156|NCT03656198|Biological|Rabivax-S|Rabivax-S is a lyophilized vaccine manufactured by Serum Institute of India Pvt. Ltd. containing inactivated purified rabies antigen (Pitman Moore, PM3218 as virus strain) produced using Vero ATCC CCL 81 cells. The diluent (sterile water for injection) is provided in a separate 1 mL ampoule. After reconstitution, a single dose of 1 mL contains an inactivated, purified rabies antigen (not less than 2.5 IU), glycine (40 mg), sucrose (40 mg) and human serum albumin (25% 10 mg).
15899157|NCT03656198|Drug|Sterile Water Injection|The vaccine diluent (sterile water for injection) is provided in a separate 1 mL ampoule.
15899158|NCT03656172|Biological|Haemoglobin measure|Haemoglobin measure before and one month after standard iron treatment
15899159|NCT03656159|Behavioral|Cognitive-Behavioral group therapy|Intervention will consist of eight weekly sessions of two hours each with a break of 15 minutes. The CBT will be delivered by a clinical psychologist and a clinical neuropsychologist previously trained in this therapeutic approach.
15899160|NCT03656159|Behavioral|Non directive support Group|Intervention will consist of eight weekly sessions of two hours each with a break of 15 minutes. The support group will be delivered by Ph.D. students having no experience with CBT.
15899161|NCT03656146|Other|Food Insecurity Screening Tablet|The intervention is the type of screening modality used to identify food insecurity: verbal face-to-face, or tablet-based screening
15899162|NCT03656146|Other|Food Insecurity Screening Verbal|The intervention is the type of screening modality used to identify food insecurity: verbal face-to-face, or tablet-based screening
15899163|NCT03656133|Radiation|Radiotherapy fractionation|Standard fractionation at 2Gy once daily or Hyperfractionation at 1.2 Gy twice daily (≥ 6 hours apart)
15899164|NCT03656120|Drug|0.2mg group|Thienorphine hydrochloride dose was set as 0.2mg per day,last for 12 weeks.
15899165|NCT03656120|Drug|0.5mg group|Thienorphine hydrochloride dose was set as 0.2mg per day for the first week and increased to 0.5mg per day from the second week, last for 11 weeks.
15899166|NCT03656120|Drug|placebo control group|Participants only take placebos for 12 weeks during the research.
15899167|NCT03656107|Behavioral|Cognitive Training|Lumosity© is a commercially available software, developed by a group of neuropsychologists, which has been used across several studies of brain training and disciplines. The brain training software targets multiple brain areas, is based online, and is relatively easy to use and administer. It has been designed to adapt to the individual's memory performance to personalise the training program to their needs. Brain exercises will be selected with the support of Lumosity© to target the following brain areas; attention, memory, visuospatial, verbal fluency, and language.
15899168|NCT03656094|Drug|Pembrolizumab plus chemotherapy|Pembrolizumab plus chemotherapy
15899169|NCT03656094|Drug|Placebo plus chemotherapy|Placebo plus chemotherapy
15899170|NCT03656081|Drug|inhaled Ambisome®|inhaled liposomal amphotericin B = inhaled LAmB
15899171|NCT03656081|Drug|inhaled placebo|inhaled isotonic saline
15899172|NCT03656081|Drug|Itraconazole|Itraconazole tablet
15899173|NCT03656068|Drug|Nitazoxanide 500mg BID|Patients will receive 500mg of Nitazoxanide BID daily for 24 weeks
15899174|NCT03656042|Drug|Filgrastim (75mcg/0.3ml)|"Subjects who meet all eligible requirements for entry into the study will be randomized into one of the two treatment groups in 1:1 ratio as shown below:
~10 microgram/kg/day, by sc, for 5 continuous days for the first week, rest for 11 weeks; repeat dosing regimen every 12-weekly (12 weeks / cycle) for 2 cycles
~Non-treatment"
15899175|NCT03656029|Drug|Cannabis|Participants will smoke as much of the cigarette as they wish
15899176|NCT03656029|Drug|Placebo|Participants will smoke a placebo cigarette
15899177|NCT03656016|Device|Magnetic Resonance Imaging|Phase contrast magnetic resonance imaging technique
15899178|NCT03656003|Device|Procore biopsy needle|EBUS-TBNA with the EchoTip ProCore needle (Cook Medical Inc., Bloomington, Ind., USA)
15899179|NCT03656003|Device|Conventional biopsy needle|EBUS-TBNA with the conventional 22-gauge EBUS-TBNA needle (Vizishot, Olympus, Japan)
15899180|NCT03655990|Device|Treatment with the JUVORA™ Dental Disc|treatment with the JUVORA™ Dental Disc
15899181|NCT03655977|Drug|68Ga-NODAGA-E[c(RGDyK)]2|200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 will be administered before external beam radiation therapy (EBRT).
15899182|NCT03655977|Device|PET/MRI scan instead of only MRI|Following injection of RGD-PET the patients will be subjected to PET/MRI of the pelvic for planning external beam radiation therapy.
15899183|NCT03655977|Drug|68Ga-NODAGA-E[c(RGDyK)]2|200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 will be administered before brachytherapy (BT).
15899184|NCT03655977|Device|PET/MRI scan instead of only MRI|Following injection of RGD-PET the patients will be subjected to PET/MRI of the pelvic for planning brachytherapy.
15899185|NCT03655964|Drug|Olmesartan|At Day 4 of stroke onset, patients with clinic BP >160/100 mmHg will receive olmesartan 20 mg once daily until Day 7 of stroke onset
15899186|NCT03655964|Drug|Nebivolol|At Day 4 of stroke onset, patients with clinic BP >160/100 mmHg will receive nebivolol 5mg once daily until Day 7 of stroke onset
15899187|NCT03655964|Other|No antihypertensive treatment|Patients will be left without treatment
15899188|NCT03655951|Behavioral|Web-based resource on adolescent sexual health|Web-based resource on adolescent sexual health than the intervention.
15899189|NCT03655951|Behavioral|Alternate web-based resource on adolescent sexual health|This is a different web-based resource on adolescent sexual health than the intervention.
15899190|NCT03655938|Procedure|Piezocision combined minimally invasive alveolar bone regeneration|The piezocision surgery was performed two weeks after orthodontic appliance placement. The patients received local anesthesia in mandibular arch and vertical interproximal incisions were made below the interdental papillae in the midline, from the mesial aspect of each canine and in between each of the posterior lower teeth. The periostium was then released in order to create two subperiotal envelopes connecting the vertical incisions together. Thereafter, corticotomies were performed in the region of the incisions with a piezotome (Acteon, Merignac, France) and the envelopes were filled with a beta tricalcium phosphate, a resorbable biomaterial in order to thicken the buccal bone plate. Resorbable 5-0 sutures were used to close the flaps. Careful tooth brushing and the use of a mouthwash (chlorhexidine 0.2% Perio-Aid, Dentaid Benelux, Houten, Netherlands) were recommended for 7 days.
15899191|NCT03655925|Diagnostic Test|plasmatic HLA-G|plasmatic HLA-G by blood sample
15899192|NCT03655912|Device|Red/green glasses|The use of red/green glasses and electronic devices for two hours a day during 4 months.
15899193|NCT03655912|Device|Electronic Tablet|The use of eye patch on the fellow eye and electronic tablet for 2 hours a day during 4 months.
15899194|NCT03655912|Device|Eye patch|The use of eye patch on the fellow eye and near vision activities for 2 hours a day during 4 months.
15899195|NCT03655886|Procedure|radical prostatectomy|can be performed either open, laparoscopic or robot-assisted, which is chosen by the discretion and expertise of the performing surgeon
15899196|NCT03655886|Radiation|Whole pelvis radiotherapy|radiation of prostate bed and pelvis
15899284|NCT03655158|Device|ozone device ( Ozonytron XL )|The adjustment of the ozone generator was %75 power for 30 seconds (75 ug/ml) based on manufacturer's instructions
15899198|NCT03655873|Drug|Placebo capsule|"single ascending-dose study: 5-、10-、15-、30-、60-、90-、120mg placebo capsule in day1.
~Multiple ascending-dose study:
~15-、30-、60mg placebo capsule in day1-day7，2 times everyday."
15899199|NCT03655860|Device|SIMEOX|SIMEOX is a device generating a succession of gentle depression at the mouth.
15899200|NCT03655847|Drug|Dexmedetomidine|Dexmedetomidine was injected intravenously 30 minutes before the end of operation. Single bolus is for more than 1 minute. In the first case, the dosage of dexmedetomidine was 0.1 ug/kg. If the cardiovascular reaction was positive (mean arterial pressure or heart rate was more than 20% before intravenous injection), the dosage of Dexmedetomidine in the next patient decreased by a gradient (0.05ug/kg). If the cardiovascular response was negative, the next patient increased the dose of dexmedetomidine by a gradient (0.1ug/kg); if a patient withdrew from the study, the next patient received the same dose as the patient who withdrew.
15899201|NCT03655834|Drug|Pemetrexed|patients will be administered a microdose with subsequent pharmacokinetic assessment.
15899202|NCT03655821|Drug|Pemetrexed|Dosing is either based on BSA or renal function
15899203|NCT03655808|Biological|Bronchial basal cells|Bronchial basal cells transplantation
15899204|NCT03655795|Biological|Bronchial basal cells|Autologous transplantation of bronchial basal cells
15899205|NCT03655782|Behavioral|PATH neurotraining|Improve visual timing and sensitivity in the dorsal stream. The mTBI subject will sit 57 cm in front of a computer monitor. During the presentation, the bars in the 'fish-shaped' window in the center of the screen formed by a sinusoidal grating, move left or right very briefly. When the screen goes blank, the subject reports which way the center pattern moved by pushing the left or right arrow key. A brief tone is presented after incorrect responses. The program adaptively changes the contrast of the test pattern so that the subject detects motion at lowest contrast possible. A sequence of patterns in each training cycle that are designed to optimally activate magnocellular neurons are shown to the subject. There are two programs, the first measures the contrast needed to see one direction of movement, and the second program measures the contrast needed to see two directions of movement, requiring memory.
15899206|NCT03655782|Behavioral|Orientation Discrimination|The sham treatment will be Orientation Discrimination training that is identical to PATH training except instead of low contrast sinewave gratings moving left or right, 100% contrast stationary test and background sinewave gratings are used, both red, green, and black and white gratings. These patterns are randomly oriented left or right, at decreasing tilt angles as the test grating's orientation is identified correctly. These patterns only activate parvocells in ventral pathways (Ungerleider & Mishkin, 1982; Kaplan & Shapley, 1986) instead of activating dorsal pathways, the key components of PATH neurotraining. Therefore, this task does not speed up the brain's visual timing, which is a function of the dorsal stream. For the Orientation Discrimination task, the subject pushes the left arrow key when the test pattern is tilted left and the right arrow key when pattern is tilted right. Otherwise the two training tasks use the same paradigm.
15899207|NCT03655769|Device|transcranial direct current stimulation|transcranial direct current stimulation applied at 2 mA over the right parietal region for 20 min
15899208|NCT03655769|Device|sham transcranial direct current stimulation|transcranial direct current stimulation applied at 2 mA over the right parietal region for 30 sec
15899209|NCT03655756|Biological|IFx-Hu2.0|Subjects enrolled will receive a fixed IFx-Hu2.0 (plasmid DNA) dose of 0.1 mg injected in up to 3 lesions at a single time point (28-day follow-up post last injection).
15899210|NCT03655743|Device|LASIK, PRK, Phacoemulsification|"Please see:
~https://en.wikipedia.org/wiki/LASIK https://en.wikipedia.org/wiki/Photorefractive_keratectomy https://en.wikipedia.org/wiki/Phacoemulsification"
15899211|NCT03655730|Other|weekly psychotherapeutic individual sessions|weekly psychotherapeutic individual sessions following the IPT method during one year
15899212|NCT03655730|Other|Usual care|the standard follow-up provided by the Mission Locale, including periodic meetings with a referee
15899213|NCT03655717|Drug|Dronabinol|THC (dronabinol) at physician determined doses of 10-50mg designed to produce intoxication.
15899214|NCT03655717|Drug|Ethanol|Oral Ethanol, dosed to obtain a breath alcohol concentration (BrAC) of approximately 0.05 BrAC (equal to 1-2 standard drinks).
15899215|NCT03655717|Drug|Placebo Dronabinol|Identical in appearance to active dronabinol (overencapsulation of both active and placebo dronabinol)
15899216|NCT03655717|Drug|Placebo Ethanol|Placebo ethanol will consist of diet soda used in the active ethanol condition with 0.25ml ethanol floated on top to provide the odor of ethanol and blind the study drug.
15899217|NCT03655704|Drug|Apabetalone|A 4-week pre-treatment phase will allow ensuring that patients are on stable doses of medication. Patients will be given doses of apabetalone 100mg BID for 16 weeks. Patients will be regularly followed (Fig.1). At baseline and week 16, a cardiac catheterization and MRI will assess changes in pulmonary hemodynamics and RV function.
15899218|NCT03655691|Biological|Vehicle|Vehicle Formulation
15899219|NCT03655691|Biological|botulinum toxin, Type A|botulinum toxin, Type A, Dose 1
15899220|NCT03655691|Biological|botulinum toxin, Type A|botulinum toxin, Type A, Dose 2
15899221|NCT03655678|Biological|CTX001|Administered by IV infusion following myeloablative conditioning with busulfan
15899222|NCT03655665|Drug|Ofloxacin otic solution|Three drops of ofloxacin otic 0.3%. intra and post-operatively for 3 days post-surgery on one ear.
15899223|NCT03655626|Other|Sepsis Watch|The operational intervention comprises of a sepsis machine learning model, custom dashboard to present risk scores, and a rapid response team to monitor patients at-risk of sepsis and deliver sepsis treatment. Sepsis Watch was developed under operational management. The rapid response team will utilize information presented on the dashboard and follow a protocol that will enable them to support the primary teams of hospitalized patients.
15899224|NCT03655613|Biological|APL-501|Humanized IgG4 monoclonal antibody against programmed death receptor-1 (PD-1)
15899225|NCT03655613|Drug|APL-101|Oral specific c-Met inhibitor
15899226|NCT03655613|Biological|Nivolumab|Fully human IgG4 monoclonal antibody against PD-1
15899227|NCT03655600|Other|Self-administered acupressure|Self-administered acupressure learned through app for reduction of need for opioids post-surgery in breast cancer patients
15899228|NCT03655587|Device|Solid ankle foot orthotic|
15899229|NCT03655587|Device|Resting night splint|
15899319|NCT03654885|Procedure|Trabeculectomy|Subjects will undergo at least one preoperative visit (and more as needed), and then be scheduled for trabeculectomy.
15899230|NCT03655574|Behavioral|Motivational + Family Check-up (MET+FCU)|In the MET session, motivational strategies of individualized normative feedback, examining decisional balance, and providing information/advice will be used to support goals for behavior change and to examine barriers to changes. There are four specific phases of the FCU session: (1) Self-assessment: Parents are asked if they learned anything about their family from participating in the assessment. (2) Support and clarification: The interviewer supports the parent's self-assessment efforts, assesses their level of understanding, and clarifies issues within the family. (3) Feedback: A summary form of the assessment is reviewed. (4) Action Plan: Throughout the session, the counselor works with the parent to develop a brief, written Action Plan about communication and monitoring.
15899231|NCT03655574|Other|Psychoeducation|Psychoeducation about substances is provided to teens and parents.
15899232|NCT03655561|Other|Non interventional research|Participants are receiving the standard of care according to Nigerian Center for Disease Control (NCDC) Standard Operating Procedures for Lassa fever case management. This include the administration of intravenous ribavirin for Lassa confirmed cases as well as critically-ill Lassa suspected cases.
15899233|NCT03655535|Drug|BTI320|Non-systemic galactomannan complex polysaccharide
15899234|NCT03655535|Other|Placebo|Placebo
15899235|NCT03655522|Drug|NAVX-010|Dose levels of NAVX-010 were 2, 8, 25, 50, and 75 mcg. Four patients per active group. Each subject participated in only 1 treatment period.
15899236|NCT03655522|Drug|Placebo|There were two Placebos per group.
15899237|NCT03655509|Procedure|Dynamic test ACTH stimulation|
15899238|NCT03655496|Device|Home-based tool|The tool consists of a tablet computer and a Bluetooth connected weight scale. The patient is encouraged to use the tool daily. The weight is titrates the dose of diuretics and a short tip about how to improve living with heart failure, this is presented on the screen. Every five days the patient assess their self-perceived symptoms on the tablet computer. If the weight increases by 2kg or more in 3 days or less, the high dose is recommended for two days, after which the effect on the weight is assessed. If the weight increased was reverted, the dose is returned to normal and if it is still elevated, an alert on the table computer. If the self-assessed symptoms deteriorate, the same type of alert will appear on screen, urging the patient to contact the health care provider.
15899239|NCT03655483|Drug|GLS-010|Full-human anti-pd-1 monoclonal antibodies
15899240|NCT03655470|Behavioral|Safety Planning|Safety planning is an individual coping intervention to reduce suicidal risk in adolescents
15899241|NCT03655470|Behavioral|Standard care|Standard care entails sending an adolescent for an emergency evaluation for suicidal risk in an Emergency Department
15899242|NCT03655457|Device|group 1 Poractant alfa|Comparison of lung usg scores in infants treated with Poractant alfa and Beractant: 0 indicates A-pattern (defined by the presence of the only A-lines); 1, B-pattern (defined as the presence of ≥3 well-spaced B-lines); 2, severe B-pattern (defined as the presence of crowded and coalescent B-lines with or without consolidations limited to the subpleural space); and 3, extended consolidations.
15899243|NCT03655457|Device|group 2 beractant|lComparison of lung usg scores in infants treated with Poractant alfa and Beractant: 0 indicates A-pattern (defined by the presence of the only A-lines); 1, B-pattern (defined as the presence of ≥3 well-spaced B-lines); 2, severe B-pattern (defined as the presence of crowded and coalescent B-lines with or without consolidations limited to the subpleural space); and 3, extended consolidations.
15899244|NCT03655444|Drug|Abemaciclib|Abemaciclib is an investigational agent for this trial and will be supplied by Lilly Oncology, free of charge to the patient.
15899245|NCT03655444|Drug|Nivolumab|Nivolumab is commercially available
15899246|NCT03655444|Procedure|Tumor biopsy|"Phase II patients only
~If the patient consents, fresh tumor tissue will be collected at baseline and then during Cycle 2 (between days 8-22) of abemaciclib and nivolumab."
15899247|NCT03655444|Procedure|Peripheral blood|"Phase II patients only
~Peripheral blood will be collected at baseline, at the end of the Lead In (cycle 1 day 1 prior to treatment), during cycle 2 (between days 8-22), and during cycle 3 (between days 21-28). If patient does not have progression after cycle 3, patient will also have peripheral blood collected at time of progression."
15899248|NCT03655444|Other|EORTC QLQ-30|"Phase II patients only
~Screening , Cycle 2 D1, Cycle 4 D1, and End of treatment (EOT)"
15899249|NCT03655431|Other|Telerehabilitation|Participants complete a standard physical therapy evaluation in-person. They are then provided telerehabilitation equipment for the telerehabilitation intervention. This intervention utilizes an Xbox Kinect sensor and tablet-based exercise software called Jintronix. The Jintronix exercise library includes an array of exercise activity options for varying functional levels. Exercise activities could be completed in sitting or standing postures and includes activities which focused on active range of motion, strength, balance, or calisthenic movements. Each activity requires the participant to complete a goal-directed game or replicate movements of an on-screen avatar. The therapist will adjust and progress the home exercise program using information provided by the Jintronix and the participant's verbal reports during clinical video teleconferencing. At the end of the intervention, the therapist will complete in-person discharge assessments.
15899250|NCT03655431|Other|Standard treatment|Participants complete standard in-person physical therapy evaluation, follow-up, and treatment. Therapeutic exercise and activities will be prescribed to participants to perform at home between standard follow-up treatment appointments. At the end of the intervention, the physical therapist will complete in-person discharge assessments.
15899251|NCT03655418|Other|Resilience Curriculum (RESCUR)|"The method of the present project, developed by experts in Europe, concerns giving children their own self-empowerment, strengthening protective factors, and, in the long run, their resilience. In Sweden, the material has been named Jag vill, jag kan, jag törs!.
~The methodology that will be further developed and evaluated in this project is called RESCUR (the resilience curriculum) aimed at increasing children's resilience, i.e., children's ability to cope with crises, changes and stressors without falling apart. The method is rooted in research on human resilience."
15899252|NCT03655405|Other|Individual Deprescribing Intervention|The pharmacist responsible for the nursing home will perform a medication review (type 3). The results of this review will be discussed with the physician and nurse responsible for this participant, with the goal of creating a personalised deprescribing plan. Once validated by the physician, this plan will be submitted to the participant for approval.
15899320|NCT03654859|Other|cardiopulmonary resuscitation|no pre-specified
15899321|NCT03654846|Device|EmergencyEye|EmergencyEye Smartphone App
15899253|NCT03655392|Behavioral|Individualized educational program|IG patients were submitted to three 30-minutes intervention of a individualized shortterm educational program delivered by a nurse, were given explanations about general aspects of the disease, prevention methods and about the importance and correct use of inhaled corticosteroids, with an educational video showing the use of the device
15899254|NCT03655392|Diagnostic Test|Induced sputum collection|All participants performed induced sputum collection
15899255|NCT03655392|Diagnostic Test|Spirometry|All participants performed spirometry test using a Koko spirometer. Pulmonary function was assessed by spirometry prebronchodilator, after withholding short-acting beta-agonists for ≥ 6 hours and long-acting beta-agonist for ≥ 24hours. Forced expiratory volume in one second (FEV1) % predicted was used as a proxy variable for overall lung function.
15899256|NCT03655392|Diagnostic Test|Nitric oxide measure|All participants performed nitric oxide measure in three Mylar bags and measure was performed in a NOA280 Sievers equipment. For collection the patients blew in the balloons through a sterile nozzle in the equipment collector without prejudice or damage to the patient.
15899257|NCT03655392|Other|Questionnaires ACT, ACQ, AQLQ, BDI|All participants answered standardized questionnaires about asthma symptoms and depression: Asthma Control Test (ACT), Asthma Control Questionnaire (ACQ), Asthma Quality Life Questionnaire (AQLQ), Beck Depression Inventory (BDI)
15899258|NCT03655392|Other|Symptoms Diary|All participants were instructed to note in the morning and evening before the use of routine inhaled corticosteroids, asthma symptoms (coughing, wheezing, shortness of breath, use of emergency inhaled corticosteroids) and three measures of peak expiratory flow (individual, provided to patients) and to return this completed diary at each study visit
15899259|NCT03655392|Diagnostic Test|Peak flow measure|All participants registered three peak flow measures in the symptoms diary by morning and night before the use of routine inhaled corticosteroids. Peak flow was measured by the electronic peak flow meter (Mini-Wright).
15899260|NCT03655392|Diagnostic Test|Exhaled breath condensate air measurement|Exhaled breath condensate was collect during 15 to 20 minutes in a Turbo DECCS equipment (Medivac SRL, Italy) in a sterile buccal of the own apparatus with the aid of a nasal clip with the participant breathing normally without any effort or damage.
15899261|NCT03655379|Device|Fetal nasal Doppler by ultrasonography|Pregnant patients who present with preterm labor will be evaluated with ultrasonography and fetal nasal Doppler will be used to detect specific fetal breathing patterns and measurements will be performed
15899262|NCT03655366|Other|Questionnaire for Dog owners|Questionnaire directed to epileptic patients, parents of epileptic children and legal representatives of epileptic patients with intellectual disabilities. It includes questions about demographics, epilepsy diagnosis, seizures, the behavior of their dogs around the time they have a seizure and a validates scale to measure dog personality traits.
15899263|NCT03655366|Other|Questionnaire for Dog trainers|Questionnaire for seizure response and seizure alert dog trainers including information on number of active working dogs, dog demographic information and selection criteria, the type of patient inclusion criteria they use, training methods used.
15899264|NCT03655353|Diagnostic Test|ABY-PET|Diagnostic PET for HER2 expression
15899265|NCT03655340|Drug|Alprolix|Extended half-life factor IX product
15899266|NCT03655327|Other|reach to grasp a cup|reach to grasp a cup of different weights located at different heights of table
15899267|NCT03655314|Other|NEWT|The Newborn Weight Tool (NEWT) is publicly available at www.newbornweight.org. For this intervention, NEWT will be embedded into the electronic medical record along with a flag for weight loss greater than or equal to the 75th centile of birth weight.
15899268|NCT03655314|Other|Usual care|The electronic medical record will display the weight only as weight in grams and percent weight lost from birth weight.
15899269|NCT03655301|Drug|Copanlisib (Aliqopa, BAY80-6946)|"The copanlisib dose for this study is the standard dose recently approved and also used in Phase 1, 2 and 3 studies across the copanlisib development program: 60 mg i.v. infusion administered intermittently on Days 1, 8 and 15 of a 28-day cycle.
~In this study subjects will receive a single i.v. dose of 60 mg copanlisib on day 8."
15899270|NCT03655301|Drug|Metformin|Single dose of 1000 mg is administered orally.
15899271|NCT03655275|Biological|PRP prolotherapy|PRP prolotherapy By injection 2.5ml of PRP at an interval of 2 weeks.
15899272|NCT03655275|Biological|Saline prolotherapy|Saline prolotherapy Injection 2.5 ml of saline at an interval of 2 weeks.
15899273|NCT03655262|Behavioral|Unconscious Neuro-reinforcement|Individuals will be unconsciously exposed to feared stimuli, leading to effective fear extinction while eliminating a primary cause of attrition.
15899274|NCT03655249|Other|Autogenic drainage|Autogenic drainage is an airway clearance technique that attempts to obtain the optimal airflow to evacuate the secretions. This technique uses modulation of inspiratory and expiratory airflow at different breathing level within the vital capacity.
15899275|NCT03655249|Drug|Aerosoltherapy|Aerosolized drugs are individualized for each participants, in line with current standardized practice in our hospital. Those drugs will not be modified for the purpose of this study.
15899279|NCT03655223|Diagnostic Test|Confirmatory Testing|If a newborn's screening test is positive, an experienced genetic counselor will contact the infant's mother by phone to explain the positive screening result and arrange for confirmatory testing and a follow-up appointment. If the confirmatory test is positive, then the child receives a diagnosis of the disease. Children identified with a disorder are referred for treatment, their parents receive information and counseling on what a positive diagnosis means for their child, and they are offered participation in follow-up and registry activities for the disorder.
15899280|NCT03655210|Drug|HL151|HL151(1Tab) once a day for 4 weeks of treatments
15899281|NCT03655210|Drug|placebo|HL151 placebo(1Tab, Placebo of Bepostatine salicylate) once a day for 4 weeks of treatments
15899282|NCT03655197|Drug|Doxycycline|For those participating in the Doxycycline intervention, they will take 100 mg twice daily for 1 month.
15899283|NCT03655171|Diagnostic Test|Video-based quantitative methods|The AI video analysis is used to automatically identify motion details and quantify motion features such as amplitude and angular velocity, then an algorithm will be applied to generate the degree of motor dysfunction.
15899285|NCT03655145|Other|Haplo donor stem cell transplantation|The algorithm for selection of haploidentical donor has been defined by the french society for stem cell transplantation The stem cell source will be bone marrow for haploidentical transplantation.The bone marrow collection is carried out according to the practice of each centre with a minimal target dose of 3x108 TNC/kg.
15899286|NCT03655145|Other|HLA 10/10 MUD stem cell transplantation|HLA 10/10 matched unrelated donor myeloablative transplantation
15899287|NCT03655132|Behavioral|Veteran Acceptance and Commitment Therapy for Chronic Pain|Eight online modules based on the theoretical framework of ACT for chronic pain, provided as weekly sessions that will feature an ECA (virtual therapist) as a treatment guide. The initial module is devoted to an explanation of the treatment rationale, initial psychoeducation on pain-related symptoms, pain interference, and focal concepts of ACT, and assessment of individual pain symptoms. Modules 2-4 will focus on values clarification, acceptance and willingness, mindfulness, with an emphasis on tolerance of pain-related experiences. Modules 5-7 will continue to this focus, and incorporate goal-creation and committed action exercises. Module 8 will consolidate and provide feedback on goal-related achievements, and will focus on planning for the future.
15899288|NCT03655119|Behavioral|Parent toolkit|The parent tookit is a resource that reinforces evidence-based practices for crisis management such as safety planning and means restriction and encourages parents to increase their support, supervision, and monitoring of their at risk youth.
15899289|NCT03655119|Behavioral|Enhanced Care|PES clinical staff will receive training on the best practices in brief crisis-focused interventions in emergency settings with parents and youth.
15899290|NCT03655119|Behavioral|Caring Follow-Up Messages|Parents will receive caring contacts via phone, text, or email to provide support, additional education, and problem solving assistance in the days and weeks post-discharge.
15899291|NCT03655106|Device|Standard Long IV 4.78 cm 20 g catheter|Standard Long IV 4.78 cm 20 g catheter
15899292|NCT03655106|Device|Ultra-Long IV 6.35 cm 20 g catheter|Ultra-Long IV 6.35 cm 20 g catheter
15899293|NCT03655093|Other|Validation of AMSQ questionnaire|"Participation in the study will be proposed to any patient meeting the inclusion criteria and consulting a neurologist from the SEP reference center of the University Hospital of Rennes.
~The neurologist will explain the purpose of the study to the patient, give him the information form.
~Without opposition from the patient, the neurologist will give him the self-questionnaire. The patient will fill it during the consultation. In case of disability to the upper limbs making it impossible to fill the questionnaire by the patient, it will be filled by the neurologist or the patient's companion, according to the answers given by the patient.
~While the patient completes the questionnaire, a record of clinical information will be filled in by the neurologist.
~No additional act will be performed except the questionnaire, which result will not change the patient's management."
15899296|NCT03655067|Behavioral|CATCH-IT|The CATCH-IT internet program consists of 14 modules and exercises and activities based on best practices components of depression prevention. They will be instructed to complete at least 2 modules a week, over a period of 6 weeks. This would require at least 40 minutes per week (approximately 20 minutes minimum per module).
15899297|NCT03655054|Device|eCoin Tibial Nerve Stimulation|Subcutaneous stimulation of the tibial nerve using the eCoin device.
15899298|NCT03655041|Dietary Supplement|Beta-alanine|Beta-alanine in sustained-release tablets to increase muscle carnosine content
15899299|NCT03655041|Dietary Supplement|Placebo|Maltodextrin is used as a placebo as it does not lead to any increases in muscle carnosine
15899300|NCT03655028|Behavioral|rhythmically auditory stimulation enhanced music|Patients in the intervention group will listen to music enhanced by rhythmic auditory stimulation while engaging in a 12-week home-based exercise program
15899301|NCT03655028|Behavioral|control|Patients in the control group will not listen to music while engaging in a 12-week home-based exercise program
15899302|NCT03655015|Procedure|Lung Tumor Resection|Lung Tumor Resection
15899303|NCT03655002|Drug|Cyclophosphamide|Given IV
15899304|NCT03655002|Biological|Cytokine-based Biologic Agent IRX-2|Given SC
15899305|NCT03655002|Biological|Nivolumab|Given IV
15899306|NCT03654989|Drug|Treprostinil iontophoresis|We will administer treprostinil at increasing doses by a iontophoresis.
15899307|NCT03654989|Device|Remodulin® placebo iontophoresis|"Placebo iontophoresis will be performed using Remodulin® placebo (United Therapeutics) delivered with Axion GmbH electrodes connected to a PeriIont generator (Perimed).
~Part 1: 1 administration/day, on separate days, with 72h between two doses. The intensity will be set at 120 µA during 60 minutes, i.e. a total current of 17.3 mC/cm².
~Part 2: 1 administration/day for 10 days. The intensity will be set at 120 µA during 60 minutes, i.e. a total current of 17.3 mC/cm²."
15899308|NCT03654976|Biological|HDM SLIT-tablet|Sublingual allergy immunotherapy tablet, for daily administration (1 tablet per day)
15899309|NCT03654976|Other|Placebo|Placebo sublingual tablet, for daily administration (1 tablet per day)
15899310|NCT03654963|Procedure|Medication reconciliation|Medication reconciliation is the systematic process described above.
15899311|NCT03654950|Other|No intervention|Interviews and questionnaires
15899312|NCT03654937|Biological|Influenza Vaccination|"Influenza vaccination Influsplit Tetra 2016/2017, GlaxoSmithKline GmbH & Co. KG, Munich, Germany, batch: AFLBA 152AB."
15899313|NCT03654924|Device|Laryngeal Mask|General anaesthesia using LMA will be performed as per standard procedure. A pressure gauge will be connected to the LMA using a small cable to measure the LMA cuff pressure continuously.
15899314|NCT03654911|Diagnostic Test|EEG|EEG
15899315|NCT03654911|Genetic|ApoE|ApoE
15899316|NCT03654898|Behavioral|VITAL Start: Video-based pre-ART counseling|Patients in the experimental group will receive VITAL start pre-ARV counseling (approximately 27 minutes video followed by 10 minute guided Q & A to reinforce key messages and provide an opening for individual counseling=approximately total 37 minutes). This will be delivered by study staff.
15899317|NCT03654898|Behavioral|Standard of Care|Patients randomized to the control arm will receive the usual standard of care (SOC) pre ARV initiation education with the National ARV Educational Flipchart
15899318|NCT03654885|Device|XEN group|Subjects will undergo at least one preoperative visit (and more as needed), and then be scheduled for XEN implantation
15899325|NCT03654833|Drug|Atezolizumab & Bevacizumab|PDL1 checkpoint inhibitor, VEGF inhibitor
15899326|NCT03654833|Drug|Dostarlimab and Niraparib|IG Antibody, PARP Inhibitor
15899327|NCT03654820|Device|PVP-I solution combined with NaF varnish|4-monthly application of 10% povidone-iodine solution and 5% sodium fluoride varnish
15899328|NCT03654820|Device|SDF solution|Annual application of 38% SDF solution
15899329|NCT03654807|Behavioral|High Intensity Walking|70-80% HRmax
15899330|NCT03654807|Behavioral|Casual Speed Walking|Self selected pace
15899331|NCT03654794|Biological|Cell pharmacokinetics of tacrolimus|"Three levels of tacrolimus will be tested. Each aliquot will be supplemented with an amount of tacrolimus to achieve one of these three levels of concentration.
~At 0, 5, 15, 30, 60, 120, 240mn, the samples will be separated into 2 aliquots : one dedicated to the determination of tacrolimus in mononuclear cells, the other dedicated to the determination of calcineurin activity. in mononuclear cells."
15899332|NCT03654781|Drug|Triple therapy|triple therapy:a 10-day course of a Lansoprazole (proton pump inhibitor )combined with amoxicillin (2 × 1 g daily) and clarithromycin (2 × 500 mg daily).(trio)
15899333|NCT03654781|Procedure|professional periodontal treatment|periodontal treatment consisting of mechanical periodontal treatment (scaling and root planing) Oral hygiene insruction Periodontal treatment started concurrently with triple therapy
15899334|NCT03654768|Drug|Bosutinib|Given PO
15899335|NCT03654768|Drug|Dasatinib|Given PO
15899336|NCT03654768|Other|Laboratory Biomarker Analysis|Correlative studies
15899337|NCT03654768|Drug|Nilotinib|Given PO
15899338|NCT03654768|Drug|Nilotinib Hydrochloride Monohydrate|Given PO
15899339|NCT03654768|Drug|Ruxolitinib|Given PO
15899340|NCT03654768|Drug|Ruxolitinib Phosphate|Given PO
15899341|NCT03654755|Drug|ASN002|Daily dose of ASN002 for up to 110 weeks
15899342|NCT03654742|Procedure|tonsillectomy|removal of tonsil tissue as described in the study arms
15899343|NCT03654729|Drug|Calmangafodipir (2 µmol/kg)|Bright yellow, clear solution in 20 mL colourless, single dose, glass vial
15899344|NCT03654729|Drug|Calmangafodipir (5 µmol/kg)|Bright yellow, clear solution in 20 mL colourless, single dose, glass vial
15899345|NCT03654729|Drug|Placebo|Bright yellow, clear solution in 20 mL amber, single dose, glass vial
15899346|NCT03654716|Drug|ALRN-6924|ALRN-6924 is a drug that blocks certain proteins in tumor cells called MDM2 and MDMX. These proteins may be important in the growth of some cancers. Laboratory experiments and results from studies with adults show that ALRN-6924 may stop tumor growth and, in some cases, may cause tumor cells to die.
15899347|NCT03654716|Drug|Cytarabine|Cytarabine belongs to the category of chemotherapy called antimetabolites. Antimetabolites are very similar to normal substances within the cell. When the cells incorporate these substances into the cellular metabolism, they are unable to divide
15899348|NCT03654703|Drug|Cyclophosphamide|cyclophophamide
15899349|NCT03654690|Diagnostic Test|HIV self-test|Home delivery of HIV self-test kits (OraSure OraQuick Rapid HIV test)
15899350|NCT03654690|Behavioral|Counseling|Post-Test HIV Risk ReductionCounseling
15899351|NCT03654677|Biological|inactivated hepatitis A vaccine|A single dose of the test vaccine or the control vaccine in the form of pre-filled syringe is injected intramuscularly into the deltoid muscle (not to be injected into the gluteal region), and additional vaccination is performed using the same vaccine and the same method at 6 months after the first vaccination.
15899352|NCT03654677|Biological|Havrix Inj|A single dose of the test vaccine or the control vaccine in the form of pre-filled syringe is injected intramuscularly into the deltoid muscle (not to be injected into the gluteal region), and additional vaccination is performed using the same vaccine and the same method at 6 months after the first vaccination.
15899353|NCT03654664|Biological|Inactivated hepatitis A vaccine|Inactivated hepatitis A virus antigen 250 U (Name of viral strain: TZ84)
15899354|NCT03654664|Biological|Havrix Inj|720 ELISA/0.5 mL Junior (Inactivated hepatitis A virus antigen 160 U (Name of viral strain: HM175 Inj)
15899355|NCT03654651|Drug|Peanut|Roasted, unsalted peanuts will be purchased from a local grocery store and provided to subjects to consume.
15899356|NCT03654651|Drug|High carbohydrate snack|Whole wheat crackers will be purchased from a local grocery store and provided to subjects to consume with a spread (e.g. cream cheese or margarine).
15899360|NCT03654625|Behavioral|Standard Written Exposure|Four spaced, 30-minute sessions occurring within a period of 2 weeks. Participants write a narrative about their worst worry.
15899361|NCT03654625|Behavioral|Enhanced Written Exposure|Four spaced, 30-minute sessions occurring within a period of 2 weeks. Participants write a narrative about their worst worry and rescript it.
15899362|NCT03654625|Behavioral|Control Condition|Four spaced, 30-minute sessions occurring within a period of 2 weeks. At each session, participants write a narrative about a neutral topic.
15899363|NCT03654612|Drug|Apatinib|Apatinib 500mg qd plus S-1 50mg bid d1-d14/28d cycle
15899364|NCT03654599|Behavioral|Baseline Surveys|Baseline surveys contained a series of scaled questions, including sociodemographic variables (age, sex, cancer type, and etc), profile of mood states, social well-being, emotional processing and acceptance.
15899365|NCT03654599|Behavioral|Digital Stories Intervention|Digital Stories Intervention Videos contain the following content: caregiver burden, positive and cognitive coping, support from other family and friends, fear of losing the patient, spirituality, guilt of being sick, and expressing emotions/feelings
15899366|NCT03654599|Behavioral|Information Control Intervention|Information Control Intervention Videos include Information about post-HCT. The topics in the IC include specific guidelines to return to wellness post HCT through (1) an exercise plan, (2) a nutrition (dietary) plan, (3) pain management, (4) information about the complications, (5) caregiver responsibilities, (6) social support, (7) preventing from infections, and (8) symptom management. Participants randomized to the IC will receive the full set of DS modules only after the final 3-month post-intervention data collection point has passed and they can view them as desired.
15899367|NCT03654586|Behavioral|Sugary drink warning labels|The description of each intervention appears in the descriptions of the experimental arms.
15899368|NCT03654573|Device|CorFlow Controlled Flow Infusion System - CoFI™|The CorFlow CoFI™ System is intended to assess the dynamic microvascular resistance and to treat microvascular obstruction in the coronary vasculature of patients following PCI with stent placement.
15899369|NCT03654560|Device|HemoStyp|During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Hemostyp applied in accordance to instructions for use.
15899370|NCT03654560|Device|Surgicel|During elective surgical procedure (non-laparoscopic thoracic, cardiac, abdominal, or vascular surgery) subject has mild to moderate soft tissue, vascular or parenchymal bleeding present at target bleeding site after primary standard conventional surgical hemostatic methods are proven to be ineffective or impractical will have Surgicel applied in accordance to instructions for use.
15899372|NCT03654534|Dietary Supplement|NutrenOpimum|NutrenOpimum administration was recommended with a dosage of 400 kcal/400 ml per day within 7 days postoperatively and was continued for 3 months postoperatively.
15899373|NCT03654521|Diagnostic Test|Fetal interventricular septum thickness|Two-dimensional ultrasound fetal cardiac imaging test
15899374|NCT03654508|Genetic|ADRB2-genotype guided treatment|This intervention assesses whether ADRB2 genotype-guided treatment leads to better asthma control after 3 months compared to usual care in children who are uncontrolled despite adherent and adequate use of ICS.
15899375|NCT03654508|Other|Randomisation|In the control arm, children will be randomised over double dose ICS or ICS+LABA instead of treatment according to their genotype.
15899376|NCT03654495|Other|Exergame training|"Training on Medical Device (MD): Dividat Senso, DIV-SENSO-H, Dividat GmbH, Software development: ISO 62304:2016; designed to train aspects of executive functions (EFs; divided attention, working memory, inhibition, and shifting) and physical functions through Virtual Reality video game training.
~FITT training principles are implemented; Frequency: three times per week, Intensity: individually adapted VG (allowing training progression), Type: combination of cognitive and motor training, and Time: 20 min training sessions. Training lasts 6 weeks (18 training sessions). Participants train 20 min, three times per week. Training includes one session of each VG (4 min) in a pre-defined order and short breaks (~1 min) for game change."
15899377|NCT03654495|Other|Usual Care Training|Routine (standard) therapy given based on conventional current-best-evidence Rehabilitation. Preoperative Phase: Diminish inflammation, swelling, and pain; Restore normal range of motion (especially knee extension); Restore voluntary muscle activation Immediate Postoperative Phase (Day 1-7): Restore full passive knee extension; Diminish joint swelling and pain; Restore independent ambulation Early Rehabilitation Phase (Week 2-4): Maintain full passive knee extension; Gradually increase knee flexion; Muscle training Controlled Ambulation Phase (Week 4-10): Restore full knee ROM; Improve lower extremity strength; Enhance proprioception, balance, and neuromuscular control Advanced Activity Phase (Week 10-16): Normalize lower extremity strength; Enhance muscular power and endurance; Improve neuromuscular control; Perform selected sport-specific drills.
15899378|NCT03654482|Device|SuperSeton|The SuperSeton will be placed at the outpatient clinic in patients that already have a seton in situ. This seton will then be exchanged by the SuperSeton. In case patients do not have a seton in situ, the SuperSeton can be placed at the operating theatre in day care setting instead of a regular seton.
15899379|NCT03654469|Other|questionnaires and electronic mini-spirometry|prospective screening study based on questionnaires and electronic mini-spirometry (Néo-6(®)) that includes a representative sample of dairy farmers from the departments of Morbihan and Île-et-Vilaine in Brittany
15899380|NCT03654456|Biological|OSA|The diagnosis of OSA (obstructive sleep apnea) relies on polysomnographic data showing an apnea-hypopnea index at least 5/hr with compatible symptoms.
15899381|NCT03654443|Diagnostic Test|Critical care pain observation tool|The CPOT tool is administered in a crossover manner by two study observers
15899382|NCT03654430|Other|Echocardiography|Two echocardiographies will be performed in healthy newborns: The first between day 2 and day 5 of life, the second between day 60 and day 90 of life
15899383|NCT03654417|Drug|EMLA|Patients undergoing a vulvar biopsy will be randomized to receive EMLA cream or a lidocaine injection as their numbing agent prior to the procedure.
15899384|NCT03654417|Drug|Lidocaine|Patients undergoing a vulvar biopsy will be randomized to receive EMLA cream or a lidocaine injection as their numbing agent prior to the procedure.
15899385|NCT03654404|Behavioral|Positive Psychology Intervention|Weekly phone calls with the study interventionist and positive psychology exercises over an 8-week period. The positive psychology program exercises includes three modules: gratitude-based activities, strength-based activities, and meaning-based activities.
15899386|NCT03654391|Dietary Supplement|InnoSlim|Subjects ingested 2 capsules (Experimental group) in the morning and 3 capsules in the evening (5 capsules/d) for 12 weeks of a stage. Anthropometric measurements such as body weight, body fat, waistline, hipline, blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST and ALT were measured every six weeks.
15899387|NCT03654391|Dietary Supplement|Placebo|Subjects ingested 2 capsules placebo in the morning and 3 capsules in the evening (5 capsules/d) for 12 weeks of a stage. Anthropometric measurements such as body weight, body fat, waistline, hipline, blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST and ALT were measured every six weeks.
15899388|NCT03654365|Other|Bulk ordering and bulk messaging|Patients in the intervention group had the hepatitis screening test ordered for them in bulk and then a bulk message sent to them through the personal health record describing hepatitis C and how they could be tested.
15899543|NCT03653312|Device|NMES|Neuromuscular electrical stimulation of the paretic lower limb during exercise
15899389|NCT03654365|Other|Routine alerting|Passive alerting to providers (during face-to-face encounters using the electronic health record) and to patient (when they review preventative screening recommendations through their personal health record).
15899390|NCT03654339|Procedure|root coverage|"Group A: After administration of local anaesthesia using ophthalmic microsurgical knives a V-shaped incision was made in the gingival recession area. the gingiva was removed .the adjacent partial thickness pedicle flap was reflected from the donor area .the pedicle flap was then covered over the recipient site. then secured with 6-0 absorbable sling suture without tension. the surgical procedure was done with seilar microscope 40X magnification.
~Group B: After administration of local anaesthesia using 15 no blade a V-shaped incision was made in the gingival recession area . gingiva was removed .the adjacent partial thickness pedicle flap was reflected from the donor area .the pedicle flap was then covered over the recipient site. then carefully secured with 4-0 absorbable sling suture"
15899391|NCT03654326|Drug|Gefapixant|Gefapixant tablet 45 mg taken orally
15899392|NCT03654326|Drug|Placebo|Placebo matching gefapixant tablet taken orally
15899393|NCT03654326|Drug|Naproxen|Naproxen sodium 275 mg tablets taken orally as needed, at dose prescribed by sites' principal investigator
15899394|NCT03654313|Biological|MEDI6570|MEDI6570
15899395|NCT03654313|Biological|Placebo|Placebo
15899396|NCT03654313|Biological|Part B Placebo|Placebo
15899397|NCT03654287|Other|Treatment|The CELS way to intervene severe sepsis and refractory shock
15899398|NCT03654274|Drug|Relugolix|Relugolix 40-mg tablet administered orally once daily
15899399|NCT03654274|Drug|Estradiol/norethindrone acetate|Capsule containing co-formulated tablet of E2 (1.0 mg) and NETA (0.5 mg) administered orally once daily
15899400|NCT03654261|Behavioral|Cognitive Behavioural Therapy|The intervention is a 1-day Cognitive Behavioural Therapy based workshop.
15899401|NCT03654248|Behavioral|Let's Get Organized group intervention|Group intervention aiming to enhance time management, targeted to persons with mental or neurodevelopment disorders. Each group has 6-8 participants and is lead by two trained group leaders. Goal-directed and other learning strategies are used to train effective time management habits such as maintaining a calendar and wearing a watch. Group sessions are structured with PowerPoint presentation and a course manual, an information from the group leaders is intermixed with discussion among the participants and tasks to complete.
15899402|NCT03654248|Device|Individual Occupational Therapy|Individual meetings with Occupational Therapist (standard therapy) during a 10-week period. Number of meetings and exact nature of intervention depends on the client's needs and is decided by the treating occupational therapist. Interventions will include prescription or instruction regarding time assistive devices and instructions regarding structure and planning of everyday life.
15899403|NCT03654235|Other|Health Education|6 pain neuroscience education sessions (10 hours) and delivery of printed reinforcement material.
15899404|NCT03654235|Other|Physical exercise|Group physical exercise program (18 sessions; 3 sessions/week) leaded by a physiotherapist. It includes exercises to improve strength, coordination, balance and aerobic capacity. Work with double tasks, recreational activities to overcome kinesiophobia and activities to do at home are used in the program.
15899405|NCT03654235|Other|Usual care in Primary Care Physiotherapy Units|"Treatment supported by the protocol of primary care of physiotherapy in the health service of Castilla y León that was in force at the time of the intervention.
~Patients receive 15 sessions of analgesic electrotherapy, thermotherapy and standardized physical exercise"
15899406|NCT03654209|Device|Argon Plasma Coagulation|APC will be applied to the perimeter of the resection site
15899407|NCT03654209|Device|Snare Tip Soft Coagulation|STSC will be applied to the perimeter of the resection site
15899408|NCT03654196|Drug|HL301(Experimental)|Total 7 days of treatment and The daily dose is as follows [Morning: HL301 1Tab + Placebo of Umkamin 1Tab] [Noon: Placebo of Umkamin 1Tab] [Evening: HL301 1Tab + Placebo of Umkamin 1Tab]
15899409|NCT03654196|Drug|Umkamin(Active Comparator)|Total 7 days of treatment and The daily dose is as follows [Morning: Placebo of HL301 1Tab + Umkamin 1Tab] [Noon: Umkamin 1Tab] [Evening: Placebo of HL301 1Tab + Umkamin 1Tab]
15899410|NCT03654183|Diagnostic Test|Indocynine green clearance test|Indocyanine green clearance was determined by non-invasive pulse spectrophotometry (NIHON KOHDEN™; Pulse Dye Densito-Graph Analyzer, Japan).
15899411|NCT03654170|Drug|BI 425809 mixed with [C-14] BI425809|Oral Solution
15899412|NCT03654144|Drug|Dienogest|oral tablets
15899413|NCT03654144|Drug|Combined Oral Contraceptive|oral tablets
15899414|NCT03654131|Device|MWA|Patients are allocated to one of the two arms in a 1:1 randomization
15899415|NCT03654131|Radiation|SBRT|Patients are allocated to one of the two arms in a 1:1 randomization
15899416|NCT03654118|Other|Phone follow-up|"Through a short phone interview :
~Determination of a complication (Infection, capsulitis, recurrence)
~Determination of the Rowe score
~Determination of the Walch-Duplay score"
15899417|NCT03654105|Drug|Cytisine|"Cytisine administration will be randomized 1:1 in standard (40 days)and prolonged treatment (84 days).
~Subjects will be educated on how to take the product and informed about possible adverse effects."
15899418|NCT03654105|Drug|Acetylsalicylic acid|The treatment will consist of Acetylsalicylic acid at 100mg once a day
15899419|NCT03654105|Other|Diet Modification and Physical Activity Increase|"It will be proposed:
~an optimal diet with the aim of favoring control of weight, abdominal fat and adequate nutritional status without increasing the levels of IGF-I and inflammatory factors or glycemic peaks, with periodic verification of the results
~a regular and sustainable physical activity program with periodic verification of the results."
15899420|NCT03654105|Diagnostic Test|early lung cancer detection|standard treatment for early lung cancer detection with ultra low dose CT
15899421|NCT03654105|Diagnostic Test|spirometry with CO test|spirometry with CO test
15899422|NCT03654105|Other|anthropometic data collection|anthropometic data collection
15899423|NCT03654105|Other|blood test|blood test to assess the metabolic and inflammatory profile
15899472|NCT03653715|Device|Clerio Vision LIRIC-modified Bifocal Contact Lens|Within this arm the investigational acofilcon B material bifocal contact lens, which has been modified with the laser and is the focus of the study, is tested. This lens is one of four (4) administered to each participant, tested on either visit 2 or 3 according to the randomization schedule, for a period of approximately 20 minutes.
15918508|NCT03509012|Drug|Cisplatin (dose level 2)|IV
15899424|NCT03654092|Behavioral|Exercise|"Home-based exercise training program that requires only minimal equipment, and is individually adaptable to the participant's exercise level (6 times per week; 15-20 min; 38 exercise cards and one interactive training agenda booklet). After randomization, a health care professional (HOMEX coach) will visit the intervention group participants at their home to set up the training location, to instruct the exercises and to establish individualized goals. Follow-up visits are planned after 3 and 8-9 weeks. Regular telephone calls will be conducted by the same HOMEX coach to motivate the patients, to discuss training progress and concrete benefits and barriers, and to adapt goals and the training program. Additional intervention elements are that a relative or friend is involved as a sparring partner to support the participant. The general practitioner is informed about the participation of his/her patient in the intervention."
15899426|NCT03654066|Drug|Botulinum toxin type A|Botox injection in the LES
15899427|NCT03654066|Device|Endoscope balloon dilator|Distal esophageal dilation
15899428|NCT03654066|Other|Patient reported outcomes|Subjects will complete two patient reported outcome measures (Eckardt and MADS).
15899429|NCT03654066|Diagnostic Test|Barium esophagram|Assess for radiologic severity of achalasia with barium column height measured 1 minute and 5 minutes after upright ingestion of barium
15899430|NCT03654053|Drug|Placebo Oral Tablet|Placebo taken once nightly at bed time.
15899431|NCT03654053|Drug|Simvastatin 40mg|Simvastatin 40mg taken once nightly at bed time.
15899432|NCT03654040|Biological|arTreg|"Eligible participants will receive a single dose of Treg product (arTreg). The target dose is at least 90 x 10^6 total cells.
~Method of receipt: peripheral intravenous (IV) infusion, administered over 20 to 30 minutes."
15899433|NCT03654040|Procedure|leukapheresis|"Leukapheresis will be the method employed to recover peripheral blood mononuclear cells (PBMCs) from the allograft recipient. The recipient will undergo the procedure prior to initiating the cyclophosphamide conditioning regimen.
~Procedure on Day -3 (-1 day) prior to Treg product (arTreg) IV infusion."
15899434|NCT03654040|Drug|cyclophosphamide|40 mg/kg administered intravenously (IV) following leukapheresis and between 1 to 3 days prior to Treg product (arTreg) infusion, per institutional standard of care.
15899435|NCT03654040|Drug|mesna|"Mesna is administered:
~Intravenously to inhibit hemorrhagic cystitis induced by cyclophosphamide, and
~In conjunction with the cyclophosphamide, per institutional practice with CTX."
15899436|NCT03654040|Drug|everolimus|EVR is approved for prophylaxis of allograft rejection in adults receiving a liver transplant. Per protocol: Post transplantation, subject will initially receive standard IS with tacrolimus (TAC),plus a mycophenolate product and/or steroids.Subsequently, evaluation for eligibility to be converted to EVR-based IS regimen will occur and, when applicable, proceed. Once the optimal EVR trough level is achieved,TAC dose will be reduced. When target EVR and TAC levels are maintained over two consecutive measurements, ALT liver function test (LFT) is ≤50 U/L, GGT LFT is ≤ the upper limit of normal or ≤ 1.5 times the baseline GGT, subject will be considered successfully converted to EVR-based IS regimen. EVR doses will be administered/monitored/adjusted over time.
15899437|NCT03654027|Drug|Anlotinib Plus Docetaxel|Anlotinib (12mg QD PO d1-14, 21 days per cycle) and Docetaxel (75mg/m2 IV d1)
15899438|NCT03654027|Drug|Docetaxel|Docetaxel (75mg/m2 IV d1)
15899439|NCT03654014|Device|SofPulse|SofPulse PEMF device treatment of the brain after traumatic injury
15899440|NCT03654001|Biological|Albumin|Human Albumin In parallel with fluid administration for volume resuscitation, patients will receive 400 ml of 20% albumin solution both at randomization (D0) and at day 1 (D1). Subsequently, from day 2 (D2) until day 90 (D90) or ICU discharge (whichever comes first), 20% albumin will be administered on a daily basis, to maintain serum albumin concentration equal to or greater than 30 g/L, based upon serum albumin determination.
15899441|NCT03654001|Other|Balanced|Balanced crystalloid solutions are traditionally crystalloid solutions containing a relatively low concentration of chloride as compared to 0.9% NaCl containing solutions (Normal Saline).
15899442|NCT03653988|Procedure|PEC I/II blocks by anesthesiologist - pre-operative|PEC I/II blocks by anesthesiologist - pre-operative; PEC I/II block to anesthetize the pectoral, intercostobrachial, third to sixth intercostal and long thoracic nerves. The PEC I/II blocks are pectoralis field blocks where local anesthetic medication is injected under ultrasound guidance between the tissue planes of pectoralis major and minor muscles (PECS I) and in the plane of the serratus anterior muscle at the level of the third rib (PEC II). Group I will have the PEC block administered by the anesthesiologist prior to surgical incision.
15899443|NCT03653988|Procedure|PEC I/II blocks by surgeon - intra-operative|PEC I/II blocks by surgeon - intra-operative; PEC I/II block to anesthetize the pectoral, intercostobrachial, third to sixth intercostal and long thoracic nerves. The PEC I/II blocks are pectoralis field blocks where local anesthetic medication is injected under ultrasound guidance between the tissue planes of pectoralis major and minor muscles (PECS I) and in the plane of the serratus anterior muscle at the level of the third rib (PEC II).
15899444|NCT03653975|Other|no intervention|no intervention
15899445|NCT03653962|Behavioral|video assisted group|
15899446|NCT03653962|Behavioral|non-video group|
15899447|NCT03653949|Other|Educational intervention|It will be an interactive lecture, 60 minutes long. The class will cover physiopathology, complications, treatment and prevention of exacerbations. Audiovisual resources and practical demonstrations of usual care will be used. Individual questions will be answered during the class.
15899448|NCT03653949|Other|Aerobic exercise|The aerobic exercise program will be performed at home, on a cycle ergometer for lower limbs between 24 and 35 minutes: 5 minutes of warm-up, 14 to 25 minutes of high-intensity interval exercise and 5 minutes of cool down.
15899473|NCT03653715|Device|Johnson & Johnson 1-Day Acuvue Moist Multifocal Contact Lens|Within this arm the control etafilcon A material bifocal contact lens, which is commercially available, is tested. This lens is one of four (4) administered to each participant, tested on either visit 2 or 3 according to the randomization schedule, for a period of approximately 20 minutes.
15918868|NCT03506360|Other|Laboratory Biomarker Analysis|Correlative studies
15899449|NCT03653936|Device|HITT device|Rebion has developed a noninvasive, handheld device that uses retinal polarization scanning (RPS) to rapidly assess eye fixation and retinal integrity in adults and children. RPS can automatically detect the fixation of the human eye with proprietary technology that uses a scanned annulus of polarized laser light to create a signature that confirms central fixation within seconds. RPS requires no calibration or imaging, and eye movement recordings are not required. The HITT device is a repurposed Pediatric Vision Scanner (PVS), Rebion's first commercial product which has passed all applicable safety and performance standards.
15899450|NCT03653923|Behavioral|Exposure Therapy|"Before the treatment, subjects will have one session of psychoeducation in which the rationale for the treatment is explained. In each therapy session subjects are exposed to 20 trials (each lasting 40s) of guided exposure by a psychotherapist. Further, 20 control trials of equal length are assessed in which subjects work with an earthworm. Each session lasts for approximately 90 minutes. During the therapy additional anxiety coping strategies (e.g., controlled breathing, attention refocusing, cognitive reappraisal) are trained.
~Subjects of the waiting-list will be treated in the second study phase."
15899451|NCT03653910|Device|Airtraq|Airtraq is a kind of videolaryngoscope for intubation
15899452|NCT03653910|Device|Macintosh|Macintosh is a traditional laryngoscope for intubation
15899453|NCT03653897|Device|ID-Capsule- Active|A standard gelatin or HPMC capsule with an embedded ingestible wireless sensor.
15899454|NCT03653897|Device|Wearable Sensor|Subjects will wear an ID-Reader
15899455|NCT03653884|Diagnostic Test|Ultrasound monitoring|Ultrasound monitoring is recommended during the third trimester in search of an increase in dilation and especially the appearance of a thrombus. A particular clinical form, related to abnormal umbilical vein involvement in the infra-hepatic portal system, must be individualized because of a high risk of thrombosis. It justifies the realization of an abdominal ultrasound in the first days of life. This is an aneurysm of the umbilical vein when the umbilical vein has a diameter greater than 9 mm, or a diameter of the subhepatic segment of the umbilical vein greater than 50% of the diameter of its intrahepatic segment.
15899456|NCT03653871|Behavioral|Performing Arts Instruction|Professionally delivered performing arts curriculum
15899457|NCT03653858|Device|Vercise GEVIA deep brain stimulation (DBS) system|DBS to the superolateral branch of the Medial Forebrain Bundle (slMFB)
15899458|NCT03653845|Procedure|Endovascular chemical Ablation of Adrenal Gland|Patients in this group will be treated with partial ablation of adrenal gland by endovascular injection of dehydrated alcohol.
15899459|NCT03653845|Drug|Sequenced antihypertensvie drugs with titrated dosage|Patients will be treated with different antihypertensive drugs in two groups.
15899460|NCT03653832|Drug|Dexmedetomidine|"Patients will commence intravenous infusion of open-label study drug according to a weight-based dose regimen as early as possible post-randomisation, and within a maximum of two hours.
~Bedside clinical staff will transition patients to achieve sedation with the allocated α2-agonist agent as quickly as clinically feasible and safe, to replicate the way these drugs would be used in routine practice. Additional opiate will be used for analgesia using clinical judgement. Once established, additional propofol will only be used when the maximum α2-agonist dose is reached or because cardiovascular or other side-effects limit dose escalation."
15899461|NCT03653832|Drug|Clonidine|"Patients will commence intravenous infusion of open-label study drug according to a weight-based dose regimen as early as possible post-randomisation, and within a maximum of two hours.
~Bedside clinical staff will transition patients to achieve sedation with the allocated α2-agonist agent as quickly as clinically feasible and safe, to replicate the way these drugs would be used in routine practice. Additional opiate will be used for analgesia using clinical judgement. Once established, additional propofol will only be used when the maximum α2-agonist dose is reached or because cardiovascular or other side-effects limit dose escalation."
15899462|NCT03653832|Drug|Propofol|Patients will continue to receive intravenous propofol according to current usual care.
15899463|NCT03653819|Other|First exercise session + compression|The Interval Training consists of a 5 minute warm-up on the stationary bike followed by 7 intervals of cycling for 1 minute at level 15-16 on the Borg Scale of Perceived Exertion. Inbetween intervals, participants reduce resistance on the stationary bike and pedals for 1 minute at level 11-12 on the Borg Scale. The session ends with a 5-10 minute cool-down pedaling and stretching exercises for the lower limbs.
15899464|NCT03653819|Other|First exercise session - compression|The Interval Training consists of a 5 minute warm-up on the stationary bike followed by 7 intervals of cycling for 1 minute at level 15-16 on the Borg Scale of Perceived Exertion. Inbetween intervals, participants reduce resistance on the stationary bike and pedals for 1 minute at level 11-12 on the Borg Scale. The session ends with a 5-10 minute cool-down pedaling and stretching exercises for the lower limbs.
15899465|NCT03653806|Other|computerized algorithm for automated analysis|"First: to develop a computerized algorithm for automated analysis of the electrical impedance tomography (EIT) data. The algorithm calculates the optimal positive end-expiratory pressure (PEEP) and inspiratory pressure defined as the optimal balance between stretch, ventilation distribution and collapse.
~Second: to compare the results of the algorithm with the current standard of care clinical judgement of experienced EIT users"
15899466|NCT03653793|Other|Natural Health Product: LivRelief Varicose Veins Cream|This product is intended to improve circulation and blood flow to minimize the appearance of varicose veins.
15899467|NCT03653780|Device|Ekso GT|Walking in the Ekso GT with maximum bilateral assistance for 20 minutes
15899468|NCT03653767|Device|Adjustable Furniture|The intervention will include adjustable school furniture.
15899469|NCT03653754|Diagnostic Test|Measurement of growth and body composition|Growth (height and body weight), and body composition were measured. For the body composition, Inbody 770 and Inbody S10 were used.
15899470|NCT03653741|Drug|Perampanel 6 MG|Perampanel is a drug approved and marketed in the USA for the treatment of epilepsy to prevent recurrent seizures. In a previous study, healthy volunteers have tolerated a single dose of perampanel at 6 mg quite well.
15899471|NCT03653728|Device|Near infrared spectroscopy|"All patients would be receiving the same treatment including application of non-invasive monitoring with near-infrared spectroscopy (NIRS) together with the standard of care with interval CT Brain scan for all patients.
~Non-invasive monitoring with near-infrared spectroscopy (NIRS) is very safe and is in current daily routine clinical use for intraoperative patients."
15899541|NCT03653325|Device|ORI measurement|Oxygen (FiO2) will be titrated according to ORI index and Oxygen saturation.
15899474|NCT03653715|Device|Johnson & Johnson 1-Day Acuvue Moist Contact Lens|Within this arm the control etafilcon A material single vision contact lens, which is commercially available, is tested. This lens is one of four (4) administered to each participant, tested on either visit 2 or 3 according to the randomization schedule, for a period of approximately 20 minutes.
15899475|NCT03653715|Device|Clerio Vision Single Vision Contact Lens|Within this arm the control acofilcon B material single vision contact lens, the material of which is commercially available from Contamac Ltd, is tested. This lens is one of four (4) administered to each participant, tested on either visit 2 or 3 according to the randomization schedule, for a period of approximately 20 minutes.
15899476|NCT03653702|Drug|Lumason|Lumason will be used as the contrast agent. Standard Lumason dose will be used: 0.03mL/kg up to a maximum dose of 2.4 milliliter (mL) per injection
15899477|NCT03653689|Dietary Supplement|FODMAP|The intervention will run for seven weeks. During the whole intervention, the participants will hold a baseline diet with no gluten and low intake of FODMAPs. The first week, the participants will consume a one-time cocktail provocation consisting of gluten (17.3 gram) and FODMAPs (50 gram) Thereafter, study participants will receive three 1-week diets with additions of either FODMAPs, gluten or an inert control with 1-week washout in-between. The daily amount for gluten will be 17.3 gram and the daily amount for FODMAPs will be 50 gram. The order of the three weeks with extra diets (gluten/FODMAPs/control) will be randomized.
15899478|NCT03653689|Dietary Supplement|Gluten|The intervention will run for seven weeks. During the whole intervention, the participants will hold a baseline diet with no gluten and low intake of FODMAPs. The first week, the participants will consume a one-time cocktail provocation consisting of gluten (17.3 gram) and FODMAPs (50 gram) Thereafter, study participants will receive three 1-week diets with additions of either FODMAPs, gluten or an inert control with 1-week washout in-between. The daily amount for gluten will be 17.3 gram and the daily amount for FODMAPs will be 50 gram. The order of the three weeks with extra diets (gluten/FODMAPs/control) will be randomized.
15899479|NCT03653689|Dietary Supplement|Placebo|The intervention will run for seven weeks. During the whole intervention, the participants will hold a baseline diet with no gluten and low intake of FODMAPs. The first week, the participants will consume a one-time cocktail provocation consisting of gluten (17.3 gram) and FODMAPs (50 gram) Thereafter, study participants will receive three 1-week diets with additions of either FODMAPs, gluten or an inert control with 1-week washout in-between. The daily amount for gluten will be 17.3 gram and the daily amount for FODMAPs will be 50 gram. The order of the three weeks with extra diets (gluten/FODMAPs/control) will be randomized.
15899480|NCT03653676|Other|Exercise Test (CIIT)|The CIIT exercise test will consist of 8 bouts (2 minute each) of constant workload cycling with rest periods (1 minute each) in between each bout of exercise. Subjects and controls will be randomized to either a moderate intensity or vigorous intensity, defined as 50% or 70% of the maximal workload achieved on the maximal cardiopulmonary exercise test (CPET).
15899481|NCT03653663|Drug|Simvastatin 20 mg|Subjects are treated with 20 mg simvastatin for 8 weeks
15899482|NCT03653663|Drug|Placebo Oral Tablet|Subjects are treated with placebo for 8 weeks
15899483|NCT03653650|Combination Product|PRP plus BCL|Bandage contact lens (BCL) plus 1 autologous platelet-rich plasma (PRP) eye drop every 1 to 3 hours.
15899484|NCT03653650|Combination Product|BCL plus PFL|Bandage contact lens (BCL) plus 1 preservative-free lubricant (PFL) eye drop every 1 to 3 hours.
15899485|NCT03653650|Combination Product|Eye patch plus ocular lubricant ointment|Eye patch plus ocular lubricant ointment every 24 hours.
15899486|NCT03653637|Behavioral|Project Life Force|A novel, 10-session group intervention to enhance currently mandated VA suicide safety planning by involving Veterans who are at high-risk for suicidal. The PLF intervention augments the SSP in a group treatment with skills training, and psychoeducation, to maximize use and effectiveness of the plan. Overall, PLF aims to enhance suicide coping skills, safety planning and connection to others. The primary purpose is to enhance the safety plan with skills training in emotion regulation, building of support and distress tolerance, and enable even acutely-suicidal Veterans to be able to implement the steps of the safety plan.
15899487|NCT03653637|Behavioral|Treatment as Usual|The comparison condition will be an assessment-only treatment-as-usual (TAU). Participants in the TAU condition will receive safety planning and specified clinical support, as mandated by their high-risk status.
15899488|NCT03653624|Other|No intervention|No intervention is involved int his study. Fully anonymised blood pressure data will be collected from the vital signs monitors in the operating room.
15899494|NCT03653598|Other|Atrial Fibrillation|Data collection on Atrial Fibrillation
15899542|NCT03653325|Device|oxygen saturation measurement|Oxygen (FiO2) will be titrated according to oxygen saturation
15918869|NCT03506360|Biological|Pembrolizumab|Given IV
15899495|NCT03653572|Device|Ultrasound exam|Eligible subjects will be positioned for their ultrasound exam, which will take a similar amount of time and be performed in a similar manner as standard of care ultrasound exams at the site. The type and duration of ultrasound exam will be based on the subject's clinical condition.
15899496|NCT03653559|Behavioral|Home meals|"Adult participants with overweight or obesity are asked to consume home meals during 12 weeks."
15899497|NCT03653559|Behavioral|Healthy meals|"Adult participants with overweight or obesity are asked to consume healthy meals during 12 weeks."
15899498|NCT03653546|Drug|AZD3759|Advanced Non-Small Cell Lung Cancer (NSCLC) with CNS metastases.
15899499|NCT03653546|Drug|Erlotinib|SoC EGFRTKI Erlotinib 150 mg PO Q.D
15899500|NCT03653546|Drug|Gefitinib|SoC EGFRTKI Gefitinib 250 mg PO Q.D
15899501|NCT03653533|Device|MiniMed™ 640G|The MiniMed™ 640G corresponds to the medical device = pump using for the delivery of insulin
15899502|NCT03653533|Device|Captor CGM Enlite®|The Captor CGM Enlite® corresponds to the device added for the measurement of the glycemic level
15899503|NCT03653533|Device|SmartGuard®|This SmartGuard® function is used to improve the glycemia stability in real condition
15899504|NCT03653520|Drug|Diazepam|5 or 10mg
15899505|NCT03653520|Drug|Tramadol|50mg or 100mg
15899506|NCT03653520|Drug|Ondansetron|1 or two tabs
15899507|NCT03653520|Drug|MKO melt|1 or 2 MKO melts
15899508|NCT03653507|Drug|zolbetuximab|Zolbetuximab will be administered as a minimum 2-hour IV infusion.
15899509|NCT03653507|Drug|oxaliplatin|Oxaliplatin will be administered as a 2-hour IV infusion.
15899510|NCT03653507|Drug|capecitabine|Capecitabine will be administered orally twice daily (bid).
15899511|NCT03653507|Drug|placebo|Placebo will be administered as a minimum 2-hour IV infusion.
15899512|NCT03653494|Procedure|phrenic block|phrenic block by 1% ropivacaine 5ml
15899513|NCT03653494|Procedure|no phrenic block|no phrenic block
15899514|NCT03653481|Dietary Supplement|Oligofructose-enriched Inulin OI|Consumed as a powder, 8g/d for children <50kg and 16g/d for children ≥50kg, divided in 2 daily doses.
15899515|NCT03653481|Dietary Supplement|Maltodextrin|Consumed as a powder, 8g/d for children <50kg and 16g/d for children ≥50kg, divided in 2 daily doses.
15899516|NCT03653468|Behavioral|Concurrent training (CT)|The core part of each session included resistance training (RT) followed by aerobic training exercises (for 50 and 30 minutes, respectively) and was preceded and followed by a 5-minute warm-up and cool-down with callisthenic movements.
15899517|NCT03653455|Behavioral|Email reminders|Patients will receive email reminders until their PROs are completed.
15899518|NCT03653455|Behavioral|pre-operative discussion|Patients will discuss the importance of PROs with their provider pre-operatively.
15899519|NCT03653455|Behavioral|Pre- and Post-operative discussion|Patients will discuss with their provider the importance of PROs pre-operatively, as well as their post-operative progression in comparison to established norms.
15899520|NCT03653455|Behavioral|Incentive|Patients will receive up to $30 in amazon gift cards upon the completion of their PROs.
15899521|NCT03653429|Drug|Tranexamic Acid|administered prior to surgical incision
15899522|NCT03653429|Drug|Normal saline|administered prior to surgical incision
15899523|NCT03653416|Device|Ipack|IPACK block - local anesthesia injected safely under ultrasound guidance in the interspace between the popliteal artery and capsule of the knee.
15899524|NCT03653416|Drug|Bupivacaine|20 cc of bupivacaine(o.25%) injection
15899525|NCT03653416|Procedure|Peri Articular Infiltration|Adductor Canal Catheter and Peri Articular Infiltration
15899526|NCT03653403|Drug|IDP-126 Gel|Component A
15899527|NCT03653403|Drug|Control Gel|gel
15899528|NCT03653390|Behavioral|EnhanceWellness for Disability (EW-D)|Participants work one-on-one with the study Wellness Coach to identify health self-management problems, consider options, develop goals and an action plan, and make adjustments to that plan over time.
15899529|NCT03653390|Behavioral|Wellness Education|Sessions will cover: (1) blood pressure management; (2) smoking cessation; (3) cancer screening; (4) regulation of blood glucose; (5) decreasing LDL cholesterol; (6) physical activity; (7) bone, joint, and muscle health; and (8) immunizations.
15899530|NCT03653377|Other|Self administrated questionnaire|Questionnaires are distributed to patients with their parents during their visit to the CF center.
15899531|NCT03653364|Drug|Baloxavir Marboxil|"Participants will receive single oral dose of baloxavir marboxil on Day 1 based on body weight and age.
~Participants will be recruited in parallel to the following three cohorts:
~Cohort I: ≥ 3 months to < 12 months old (minimum 8 participants): 2 mg/kg
~Cohort II: ≥ 4 weeks to < 3 months old (minimum 4 patients): 1 mg/kg
~Cohort III: birth to < 4 weeks old (minimum 4 patients): 1 mg/kg"
15899532|NCT03653351|Device|Active Transcranial Direct Current Stimulation (tDCS)|Transcranial Direct Current Stimulation (tDCS) is a form of neurostimulation (also known as neuromodulation) where very low levels of direct electrical current are delivered to specifically targeted areas of the brain, in order to increase neuroplasticity. The direct current in active tDCS will be of 2 mA (current density = 0.57 A/m2) and will be applied for approximately 30 minutes per day during meditative practices of the MBSR protocol.
15899533|NCT03653351|Device|Sham Transcranial Direct Current Stimulation (tDCS)|Transcranial Direct Current Stimulation (tDCS) is a form of neurostimulation (also known as neuromodulation) where very low levels of direct electrical current are delivered to specifically targeted areas of the brain, in order to increase neuroplasticity. The direct current in active tDCS will be of 2 milliampere (mA) (current density = 0.57 A/m2), however, the device is pre-programmed to turn off after 1 minute of active stimulation (and then turn back on briefly at the end of the 30 minutes).
15899534|NCT03653338|Biological|CD3/CD19 depleted leukocytes|Negative selection for CD3+/CD19+ cells will be performed on the CliniMACS® depletion device.
15899535|NCT03653338|Biological|CD45RA depleted leukocytes|Negative selection for CD45RA will be performed on the CliniMACS® depletion device.
15899536|NCT03653338|Drug|Hydroxyurea|Sickle Cell Disease Conditioning
15899537|NCT03653338|Drug|Rituximab|Sickle Cell Disease Conditioning
15899538|NCT03653338|Drug|Alemtuzumab|Sickle Cell Disease Conditioning
15899539|NCT03653338|Drug|Fludarabine|Sickle Cell Disease Conditioning
15899540|NCT03653338|Drug|Thiotepa|Sickle Cell Disease Conditioning
15918870|NCT03506347|Drug|Vancomycin|Antibiotic
15899544|NCT03653299|Device|Placebo or Active Phototherapy (MR4)|Phototherapy, placebo or active, will applied in 9 different points of anterior muscle of the thigh, 6 different points of posterior muscle of the thigh and 2 different points of the gastrocnemius muscle, bilaterally. Once a week during for 4 weeks, before the tests, the phototherapy programs (1, 2, 3 and 4) order will depend of the group randomized. The 10 subjects will do the three-dimensional gait analysis, muscle activity during gait, evaluation of mobility, static and functional balance, and mobility tests.
15899545|NCT03653286|Other|NMES and Run|"NMESIn this exercise protocol for quadriceps strengthening using NMES, the medium-frequency alternating current (1KHz with 10% of the work cycle) 4 will be used. The total daily training time is 900sec (15min), it is expected to perform 45 contractions per training, with three workouts per week for six weeks.
~RUN: It will be allowed to carry out training drills that comprise 15-40Km per week, being allowed a minimum of 2 and a maximum of 3 training sessions per week, not being able to carry out drills of explosion and during each training must be covered at least 5km and at most 15km. These limitations were based on the American College of Sports Medicine (ACSM) cardiorespiratory training guidelines to minimize confounders of cardiopulmonary performance."
15899546|NCT03653286|Other|Only Run|RUN: It will be allowed to carry out training drills that comprise 15-40Km per week, being allowed a minimum of 2 and a maximum of 3 training sessions per week, not being able to carry out drills of explosion and during each training must be covered at least 5km and at most 15km. These limitations were based on the American College of Sports Medicine (ACSM) cardiorespiratory training guidelines to minimize confounders of cardiopulmonary performance.
15899547|NCT03653273|Other|DMT withdrawal|Group 1 (DMT withdrawal) will not undergo any disease modifying treatments (DMT).
15899548|NCT03653273|Drug|DMT continuation|Group 2 (DMT continuation) may undergo the DMT . The therapy continued in this research is the one previously established, at the same dose, not implying additional precautions for use.
15899549|NCT03653260|Drug|Lidocaine (Zingo)|0.5 mg lidocaine, 20 bar pressure
15899550|NCT03653260|Drug|Placebo|Placebo injector, 20 Bar pressure, empty injector
15899551|NCT03653247|Biological|Plerixafor|Plerixafor subcutaneous injection will be administered prior to apheresis.
15899552|NCT03653247|Drug|Busulfan|Busulfan IV infusion will be administered as myeloablative conditioning therapy.
15899553|NCT03653247|Genetic|BIVV003|BIVV003 will be administered as an IV infusion following myeloablative conditioning with busulfan.
15899554|NCT03653234|Device|TV-based Assistive Integrated Service|"TV-AssistDem is an interactive platform which has been adapted specifically for people with MCI and mild dementia through a structured process. The application is intended to be used daily at home, mainly by the participants themselves, with the help of their informal caregivers. The device consists of an Android software and hardware TV (a Digital TV STB with Android technology).
~The core services of the platform are: 1) Calendar and reminders, 2) Health tracking and data transmission and 3) Videoconference; service-oriented applications are: 4) Cognitive stimulation (Stimulus© software); 5) Reminiscences; and 6) Patient and caregiver advice."
15899555|NCT03653221|Other|Standard patients with VRNET|In group of standard patients with VRNET, the medical students examine the standard patient of neurologic deficits. When they examine, they get some information of neurologic signs via the VRNET which presents neurologic deficits directly by alternating facial expressions. The students should interpret that signs to have a diagnosis.
15899556|NCT03653221|Other|standard patients|In group of standard patients, those neurological deficits are presented only by words or pictures which are not realistic.
15899557|NCT03653208|Drug|hzVSF-v13|Dosage form: 10mg / 20mg / 50mg / 100mg / 200mg / 400mg / 800mg / 1200mg of hzVSF-v13 (40 mg/mL in a 5 mL vial) Frequency: Dose at Day 1 (single administration)
15899558|NCT03653208|Drug|Placebo|Dosage form: 0.9% NaCl Solution Frequency: Dose at Day 1 (single administration)
15899559|NCT03653195|Other|urine metabolomics|We aim to determine of a specific urine metabolomic biomarkers can diagnose concussion.
15899560|NCT03653182|Diagnostic Test|Pulse, tongue image, and voice sound|They are four diagnosis methods of TCM
15899561|NCT03653169|Device|Transcranial Magnetic Stimulation|TMS is a form of noninvasive brain stimulation. An external electromagnetic coil is placed on the head, and a large current is passed through an insulated wire coil held flat on the surface of a subject's scalp in a fraction of a millisecond. This pulse of current induces a weak electrical current within the surface brain cortex. Repetitive trains of TMS pulses (repetitive TMS or rTMS) can transiently modulate corticospinal excitability following the rTMS train. When current is delivered at high frequency (10 Hz), it may simultaneously increase the activity of the brain at this site. In this study, individuals will receive 10 treatments with intermittent theta burst stimulation (twice daily for 5 days).
15899562|NCT03653143|Behavioral|JASPER|JASPER is a therapist and parent-mediated intervention that (1) targets the foundations of social communication, (2) uses naturalistic behavioral strategies to increase the rate and complexity of social communication and (3) includes parents as implementers of the intervention to promote generalization across settings and to ensure maintenance. This intervention is individualized and centered around two key developmental domains critical for social communication function: joint engagement and joint attention.
15899563|NCT03653130|Behavioral|Crossroads Orchestra Participatory Music Program|The intervention is a participatory music program where adults engage in music-making as members of a strings orchestra.
15899564|NCT03653117|Device|Transperineal laser ablation|Minimal invasive coagulation of prostatic tissue by laser
15899565|NCT03653104|Behavioral|Melodica Intervention|The melodica program will include education about pursed lip breathing, instruction in the melodica instrument, and participation in a melodica training group which meets twice-weekly for an 8-week period. Each session will include musical instruction, group music-making, and education about COPD and related health topics.
15899566|NCT03653104|Behavioral|Pulmonary Health Education|A single session including education about COPD and related health topics.
15899567|NCT03653091|Device|Duodenal Mucosal Resurfacing (DMR)|The Fractyl DMR procedure utilizes the Revita™ Catheter to perform hydrothermal ablation of the duodenum. The catheter is delivered trans-orally over a guide-wire to first inject saline to lift the sub-mucosal space, followed by an ablation of the duodenal mucosa. Subjects who receive the DRM treatment are followed for 48 weeks while Sham subjects who cross over and undergo the DMR procedure at 24 weeks are followed for further 24 weeks post treatment. Sham subjects who choose not to cross over are discontinued from the study.
15919897|NCT03498690|Behavioral|Role specific|Stakeholder groups: a or b
15899568|NCT03653091|Device|Duodenal Mucosal Resurfacing Sham (Sham)|The Sham procedure consists of placing the Revita™ Catheter as described above into the duodenum for a minimum of 30 minutes and then removing it from the patient.
15899569|NCT03653078|Device|Three dimensional printed digital guide|A CAD/CAM printed plate with a channel for mini-screw insertion
15899570|NCT03653052|Drug|Durvalumab|Durvalumab will be administered via an infusion in the arm, over a duration of up to 1 hour.
15899571|NCT03653039|Device|Tritube|The ultra thin tribute is used used for the ventilation of the patients in this arm
15899572|NCT03653039|Device|Standard enditracheal tube|A standard endotracheal tube is used used for the ventilation of the patients in this arm
15899573|NCT03653026|Drug|Upadacitinib (ABT-494)|Tablet; Oral
15899574|NCT03653026|Drug|Placebo|Tablet; Oral
15899575|NCT03653013|Behavioral|Usual standard of care|Participants will receive treatment and diabetes management as usual standard of care from their diabetes care team. They will also complete as part of the study visit: a pediatric quality of life scale(PedsQL,GenericScale and Diabetes Module) and diabetes related family conflict scale (DFCS-R) to assess quality of life and family stress at the start of the study.
15899576|NCT03653013|Behavioral|Neuropsychological Consultation|Children and parents in Group 2 will also complete a pediatric quality of life scale (PedsQL,Generic Scale and Diabetes Module),diabetes related family conflict scale (DFCS-R) to assess quality of life and family stress at the start of the study, as well as the self-report form of the BRIEF-2 if they are over age 11. Parents will also undergo a brief literacy and numeracy screening using the Wide Range Achievement Test, complete a parent report assessing their children's executive functioning skills at the start of the study (BRIEF-2) and they will fill out the Family Impact Module.
15899577|NCT03653000|Procedure|Ultrasound guided brachial plexus blockade|Ultrasound probe disposed on the shoulder, on the deltoid muscle. in plane puncture toward the brachial artery and injection of local anaesthetics around the brachial artery
15899578|NCT03653000|Drug|local anaesthetic injection|Local anesthetic injection (ropivacaine) at this new site
15899579|NCT03652974|Drug|sodium valproate with Clozapine|sodium valproate may be used as a synergistic agent of clozapine in the treatment of treatment-refractory schizophrenia
15899580|NCT03652974|Device|modified electroconvulsive therapy(MECT) with Clozapine|modified electroconvulsive therapy(MECT) may be used as a synergistic agent of clozapine in the treatment of treatment-refractory schizophrenia
15899581|NCT03652974|Drug|amisulpride with Clozapine|amisulpride may be used as a synergistic agent of clozapine in the treatment of treatment-refractory schizophrenia
15899582|NCT03652974|Drug|placebo with Clozapine|placebo may be used as a synergistic agent of clozapine in the treatment of treatment-refractory schizophrenia
15899583|NCT03652961|Drug|Abatacept|IV Abatacept
15899584|NCT03652948|Behavioral|Meru Health Ascend Program|Cognitive-behavioral skills, mindfulness
15899585|NCT03652935|Behavioral|Mindfulness Based Stress Reduction|
15899586|NCT03652935|Other|Health Education Series|This is an active comparator condition that consists of 8 weekly classes related to health.
15899587|NCT03652922|Drug|Reactivation Mismatch|"Ninety minutes prior to each of six weekly traumatic memory reactivation sessions, the subject will be given 0.67 mg/kg of short-acting propranolol (or placebo), rounded up to the nearest 10 mg (minimum 40 mg) and 1 mg/kg of oral long-acting propranolol or placebo (minimum 60 mg). rounded so as to achieve a dose of 60, 80, 120, or 160 mg. The subject will then read a narrative of their personal traumatic event aloud. During each weekly reading, a simple, different mismatch condition will be created by having the subject do such things as whisper the narrative, skip over every word that contains the letter e, pronounce the narrative in a different accent, or alter the tense and/or person of the narrative."
15899588|NCT03652909|Device|Ascending Hearing Technologies device|Personal Sound Amplification Device
15899589|NCT03652896|Procedure|anatomical liver resection|Liver resection is performed to achieve R0 resection for patients with appropriate BCLC staging, indocyanine green retention rate, Child-pugh grading and adequate liver remnant.
15899590|NCT03652883|Other|ItFits-toolkit|The ItFits-toolkit provides evidence-informed methods, materials, knowledge on determinants and implementation strategies, and concrete guidance on tailoring implementation strategies to local determinants of practices, apply them and evaluate their impact. It applies a standardised four-step approach to iteratively develop evidence-informed implementation strategies. The ItFits-toolkit is based on the Normalisation Process Theory (NPT), which suggests that lasting changes in practice only happen through people working together. The ItFits toolkit functions as an online self-help toolkit with minimal support. The toolkit will provide instructions for the IL to establish a core team and to create a sounding board consisting to enable co-creation.
15899591|NCT03652883|Other|Implementation as Usual|IAU refers to any existing efforts to embed and integrate iCBT within an organisation.
15899592|NCT03652870|Drug|Nortriptyline|A medication used to treat conditions such as depression
15899593|NCT03652870|Drug|Escitalopram|A medication used to treat conditions such as depression
15899594|NCT03652870|Drug|Placebo|Lactose and magnesium stearate tablet to be used as a placebo.
15899595|NCT03652857|Drug|Apatinib Combined With Vinorelbine|Vinorelbine 60mg/m2 d1qweek , Apatinib 500mg po Qd,evaluate every 2months
15899596|NCT03652844|Procedure|AAM|Subcutaneous injection procedure
15899597|NCT03652831|Other|Soft Tissue Mobilization with Neural Mobilization|"Cervical Traction for 15mints 7%of body weight with 7 second hold time and 5 second rest time.
~Hot Pack for 10mints
~Post isometric relaxation technique. The post-isometric relaxation technique begins by placing the muscle in a stretched position. Then an isometric contraction is exerted against minimal resistance. Relaxation and then gentle stretch follow as the muscle releases. Frequency for PIRs 3sets of 5 repetitions and duration of 10minute.
~Neural mobilization technique includes Median, Radial and Ulnar nerve mobilization.
~Frequency for neural mobilization is 3 sets of 10 repetitions for each and duration of 15minute. Participant will be scheduled to attend 12 treatment session (3 sessions every week for 4 weeks, 50mints each session)"
15899629|NCT03652623|Drug|TDF/FTC|In Phase 1, a PK study will be conducted to evaluate the differential PK of TDF/FTC in a cohort of transgender youth on cs-HT by conducting a PK trial of daily TDF/FTC among transgender women taking estradiol and transgender men taking testosterone (ages 15-24 years) using video-based directly observed therapy (DOT) to insure daily TDF/FTC adherence and maximize drug exposure.
15919898|NCT03498690|Behavioral|Consecutive|Stakeholder groups: a=> b
15899598|NCT03652831|Other|Soft Tissue Mobilization without Neural Mobilization|"Cervical Traction for 15mints 7%of body weight with 7 second hold time and 5 second rest time.
~Hot Pack for 10mints
~Post isometric relaxation technique. The post-isometric relaxation technique begins by placing the muscle in a stretched position. Then an isometric contraction is exerted against minimal resistance. Relaxation and then gentle stretch follow as the muscle releases. Frequency for PIRs 3sets of 5 repetitions and duration of 10minutes Participant will be scheduled to attend 12 treatment session (3 sessions every week for 4 weeks, 35mints each session)"
15899599|NCT03652818|Drug|Pre-Op pregabalin|Pre-op pregabalin will be administered 60 min prior to surgery.
15899600|NCT03652818|Drug|Pre-Op Placebo 1|Placebo 1 will be administered 60 min prior to surgery.
15899601|NCT03652818|Drug|Post-Op pregabalin|Post-op pregabalin will be administered Post-operatively.
15899602|NCT03652818|Drug|Post-Op Placebo 1|Placebo 1 will be administered post-operatively.
15899603|NCT03652818|Drug|Post-Op Placebo 2|Placebo 2 will be administered post-operatively.
15899604|NCT03652818|Drug|Post-Op acetaminophen|Acetaminophen will be administered Post-operatively.
15899605|NCT03652805|Drug|IPL344|"The study is designed to determine the tolerability, safety and PK of IPL344 administered I.V. once a day for 28 days and to identify the maximum tolerated dose.
~All patients enrolled will have a documented history of ALS disease prior to study enrollment.
~Treatment will start with 1.7mg/kg with dose escalation by 0.5 mg/kg every 3-4 days and will increase to the maximum dose of 3.2mg/kg. Day 1 to Day 28 patients will be on active treatment.
~After completion of 28 treatment days, participants who will choose to continue treatment (at the investigator's discretion), will be enrolled in a follow-up study. Participants that discontinue treatment after Day 28 will be followed up by a nurse phone call and return to the clinic for a final visit on Day 56 from the first dose."
15899606|NCT03652792|Drug|Azilsartan (Zhaoke)|Azilsartan 20mg tablets from Zhaoke
15899607|NCT03652792|Drug|Azilsartan (Takeda)|Azilva 20mg tablets from Takeda
15899608|NCT03652779|Drug|Tecarfarin 10mg|Tecarfarin 10mg tablets
15899609|NCT03652779|Drug|Tecarfarin 20mg|two tecarfarin 10mg tablets
15899610|NCT03652779|Drug|Tecarfarin 30mg|three tecarfarin 10mg tablets
15899611|NCT03652779|Drug|Tecarfarin 40mg|four tecarfarin 10mg tablets
15899612|NCT03652766|Behavioral|Daily Weight Tracking|Daily weight tracking + weekly email or text message feedback
15899613|NCT03652753|Drug|N-acetylcysteine|4 mL of a 20% solution of NAC will be injected into the ankle of patients with pilon fractures at the time of their external fixator surgery
15899614|NCT03652753|Drug|Saline|4 mL of a 20% solution of saline will be injected into the ankle of patients with pilon fractures at the time of their external fixator surgery
15899615|NCT03652740|Drug|Effects of commonly used medications on mood and medication preference|"Capsules will contain a commonly prescribed or over-the-counter medication, or placebo. A placebo is an inactive substance that looks like the study drug, but contains no active drug. The capsules given in this study may include sedatives, muscle relaxants, or anti-anxiety medications, stimulant drugs/weight loss medications, and antihistamines. More drugs are listed than will be administered to increase the degree to which volunteers are blind to the drugs being studied. Participants will not be informed of the specific drugs they will receive during or after the study. Participants will not receive any drug that is not named as a possible study drug in the written informed consent form. All the study drugs to be administered are legally marketed in the United States."
15899616|NCT03652727|Device|ECG-EM Guidance|"ECG-EM method consists on a puncture of an arm vein, under the ultrasound control and local anesthesia. The length of the PICC is estimated prior to its insertion using morphological landmarks. The placement of the PICC is done using SHERLOCK 3CG™ Diamond Tip Confirmation System (TCS) [CE marked device, C. R. Bard, Inc.].
~At the end of procedure, a chest x-ray is performed to assess the PICC position"
15899617|NCT03652727|Device|FX Guidance|"FX method consists on a puncture of an arm vein, under the ultrasound control and local anesthesia. Through the point of puncture, a long wire is then introduced and directed to the level of the target zone located in the superior vena cava under fluoroscopy control. The length of the guide inside the vessel is then measured to adjust the length of the PICC necessary for its optimal positioning.
~At the end of procedure, a chest x-ray is performed to assess the PICC position"
15899618|NCT03652714|Procedure|Ganglion sphenopalatine block with local anesthetic|Block performed with bilaterally inserted q-tips with 1:1 mixture of lidocaine 40mg/ml and ropivacaine 5mg/mL.
15899619|NCT03652714|Procedure|Ganglion sphenopalatine block with placebo|Block performed with bilaterally inserted q-tips with isotone NaCl
15899620|NCT03652701|Other|Hair Up|Herbal topical
15899621|NCT03652701|Other|Placebo|Placebo
15899622|NCT03652688|Behavioral|Three 0's|A group approach to reducing unwanted outcomes was implemented prior to entering the nightclub. The focus was on peer-to-peer intervention.
15899623|NCT03652688|Behavioral|Fire Safety|Groups were asked to read information about fire safety prior to entering the club and to answer some questions about fire safety
15899624|NCT03652675|Behavioral|Intervention: (Clinician's Guide + HealthCall for HIV/HCV)|This intervention consists of an adaptation of the National Institutes of Health (NIH) Clinician's Guide (CG; NIAAA, 2007) in conjunction with the previously tested HealthCall smartphone app program (Hasin et al., 2013; Hasin et al., 2014). Participants will complete a brief baseline meeting (~20 minutes) with a counselor to discuss alcohol use, liver function, and HIV medication adherence. They will track their drinking using HealthCall for 60 days, with brief follow-up meetings with their counselor to check in about their drinking 30 and 60 days later.
15899625|NCT03652662|Device|RESP-FIT|Inspiratory and Expiratory muscle strength training 5 times a week, plus Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)
15899626|NCT03652662|Behavioral|RESP-FIT Comparator|Fitbit activity monitoring (Daily) Daily symptom and training log entered into mobile application (SAMS)
15899627|NCT03652649|Other|3:1 ratio Ketogenic diet|Type 2 Diabetic subjects with BMI greater than or equal to 30 are started on 3:1 ratio ketogenic complete meal replacement program and weight loss and glycemic control is tracked over 6 month intervention period
15899628|NCT03652636|Drug|Sulfur Hexafluoride Microspheres|2.5 mL intravenous injection given at the time of ultrasound, with second 2.5 mL intravenous injection given during ultrasound as needed to improve visualization
15899630|NCT03652610|Biological|MenACWY liquid vaccine with approximately 30% MenA FS (GSK3536820A)|Single dose administered at Day 1, by intramuscular injection in the deltoid of the non-dominant arm
15899631|NCT03652610|Biological|Licensed GSK MenACWY vaccine (Menveo)|Single dose administered at Day 1, by intramuscular injection in the deltoid of the non-dominant arm
15899632|NCT03652597|Device|Transcranial magnetic stimulation (TMS)|Subjects receive TMS on several cortical brain locations, while recording the heart rate.
15899633|NCT03652584|Other|High Protein Diet|
15899634|NCT03652584|Other|Control Diet|
15899635|NCT03652571|Drug|Nortriptyline|"Nortriptyline escalating dose regimen:
~Week 1-2: 10mg Week 3-4: 25mg Week 5-12: 50mg"
15899636|NCT03652571|Drug|Placebo|Placebo
15899637|NCT03652558|Device|Ozone application with the Ozonytron XL device|An ozone generator (Ozonytron; Bionix, Munchen, Germany) with an KPX probe (CA Probe; Ozonytron, Bionix, Munchen, Germany) was used for OT. Topical gaseous ozone was applied into the periodontal pocket twice a week for 2 weeks based on the manufacturer's instructions. Ozone applications were at 75% power for 30 seconds (75 µg/ml). Ozone applications were performed by an experienced investigator. Ozone applications in the control side were simulated without starting the ozone generator
15899638|NCT03652545|Biological|TAA-T|Patients with newly diagnosed diffuse intrinsic pontine gliomas DIPGs (Group A) or recurrent, progressive, or refractory non-brainstem CNS malignancies (Group B). The goal of this cell infusion will be to initiate an immune response against brain tumors that includes multiple antigens and may prevent tumor evasion (through decreased expression of a single antigen)
15899639|NCT03652532|Behavioral|Alternate Day Fasting|"During the 8-week intervention, participants consumed 25% of their daily recommended energy intake (approximately 500 kcal) on each fast day (24 h), and consumed food ad libitum on each feed day (24 h). The fast day and feed day were repeated every other day, and the fast day occurred 3 days per week."
15899640|NCT03652532|Behavioral|Exercise|During the 8-week intervention, participants visited the research center gym at least three times per week and received exercise logs. Each exercise session began with 5 minutes of warm-up and ended with 5 minutes of cool-down. Resistance training was performed using weight training machines, barbells, and dumbbells for 40 minutes. Aerobic exercise was performed on motorized treadmills for 20 minutes.
15899641|NCT03652519|Behavioral|Exercise Training|Treatment in both arms consists of specific of aerobic exercise training modalities. Exercise has become an efficient strategy within rehabilitative programs and is part of a goal-orientated multidisciplinary approach to improve disability and participation in persons with MS. Recently, short and exhaustive bouts of exercise have gained much attention as a promising option in supportive care in MS.
15899642|NCT03652506|Device|regional oxymetry probe|The regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line before the disease operation begins.
15899643|NCT03652506|Procedure|Quadratus Lumborum block|Ultrasound guided unilateral anterior Quadratus Lumborum block with 20 ml %0.25 bupivacaine+The regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line before the disease operation begins.
15899644|NCT03652506|Procedure|Thoracic Epidural block|Thoracic Epidural block with 20 ml %0.25 bupivacaine+The regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line before the disease operation begins.
15899645|NCT03652493|Drug|Carboplatin|Tumoral evaluation every 3 cycles
15899646|NCT03652480|Drug|MethylPREDNISolone Acetate 40 MG/ML|
15899647|NCT03652467|Drug|Conventional TACE|Conventional chemoembolization drugs are injected through hepatic artery.
15899648|NCT03652467|Drug|Deferoxamine and conventional TACE|Deferoxamine is injected before conventional transarterial chemoembolization.
15899649|NCT03652454|Device|micro-osteoperforation|Propel device (ABD) using for regional acceleratory phenomenon
15899650|NCT03652454|Other|conventional fixed appliance treatment|conventional fixed appliance treatment
15899651|NCT03652441|Drug|Brentuximab Vedotin|BV will be administered i.v. at 1.8mg/kg at 3-weekly intervals for up to 16 infusions
15899652|NCT03652428|Drug|Gemcitabine|see arm description
15899653|NCT03652428|Radiation|Hypofractionated Ablative Proton Therapy|see arm description
15899654|NCT03652415|Device|Artificial tears (classified by MHRA as a medical device)|Use of artificial tears
15899655|NCT03652402|Procedure|kidney transplantation|samples additional to the standard of care' (SOC)will be taken at each visit (Day 0, Month 3, Month12, clinical indication)
15899656|NCT03652389|Behavioral|MJS Diabetes|patients will receive and respond to daily PRO (patient recorded outcomes) via text messages and report SMBG (self monitoring blood glucose), if insulin dependent, over the course of a 12 month period. They will also receive feedback and motivational messages based on patterns of their PROs
15899657|NCT03652389|Behavioral|Usual Care|Standard Diabetes Treatment
15899658|NCT03652376|Drug|Benralizumab|Treatment with Benralizumab 30 mg s.c. every 4 weeks (three times)
15899659|NCT03652363|Drug|glial cell line-derived neurotrophic factor|Intermittent Bilateral Intraputamenal Glial Cell Line-Derived Neurotrophic Factor (GDNF) Infusions Administered via Convection Enhanced Delivery
15899660|NCT03652350|Procedure|CT-guided microwave ablation|Using thermal ablation electrode ECO-100AL6 probe target the GGN zone with the guidance performed by CT (Bright Speed Scanner )
15899661|NCT03652337|Device|BlephEx|Electronic lid margin debridement
15899662|NCT03652337|Device|Manual debridement|Manual lid margin debridement
15899663|NCT03652324|Other|method|to compare the use of general anesthesia and deep sedation
15899664|NCT03652311|Device|ThermoNeuroModulation TNM Device|Study participants will undergo 10 sessions 15 minutes each of Caloric Vestibular Stimulation across 5 days with the FDA approved CVS device. This will be administered in home by study coordinators. Participants will be asked to fill out ODAS, GAD-7, and PHQ-9 on each of the five days during treatment; there is the possibility that other drug specific surveys will be used. Participants will receive two approximately 1 hour MRI scans at the beginning and at the end of the study period.
15899694|NCT03652064|Drug|Dexamethasone|Dexamethasone will be self-administered orally, 20 mg on Days 1, 2, 4, 5, 8, 9, 11, 12 of each 21-day cycle for Cycles 1-8. During Cycle 9 and beyond dexamethasone, will be self-administered orally at a total dose of 40 mg on Days 1, 8, 15, 22 of each 28-day cycle.
15899665|NCT03652298|Other|Memory structuring intervention + Vagal breathing|"The MSI component will teach participants to chronologically organize the segments of their memory of the incurable diagnosis, to verbally label feelings or somatic sensations they had at that moment, and to provide causal links between the event's segments and causality to their feelings and sensations, following the protocol of Gidron et al. (2001).
~In the MSI part, the patient will talk, and the therapist will note the different event parts and their real timing. Each time the patient says a feeling or sensation, the therapist will ask to verbally elaborate and provide the cause of these feelings and sensations. Then, the therapist will retell the story in a chronological manner, with verbal titles and causes for feelings and sensations. Finally, the patient will be asked to retell the story in this structured manner, after being explained how to do so.
~vagal breathing (i.e., deep, paced breathing) is a way to increase HRV, and thus parasympathetic activation"
15899666|NCT03652298|Other|support and attention (usual care)|support and attention (usual care)
15899667|NCT03652285|Device|Esophageal stent implantation|"An upper endoscopy will be performed with the use of fluoroscopy. Depending on the size of the stricture a dilation can be performed prior to the stent deployment. Otherwise, the stent will be deployed over a guidewire, under fluoroscopy.
~After, the gastroscopy will go through the esophagus to check for the stent deployment, or any complications.
~An injection of contrast agent will be done to be sure of the correct positioning and that no complications was happened.
~The patient will be kept overnight, with liquid food for 3 days and under PPI until one month after the stent placement."
15899668|NCT03652285|Device|Stent removal|Six months after implantation, the removal of the stent will be performed. Patient will undergo a first endoscopy under general anesthesia for the placement of a FCSEMS. Then, depending on the importance of the hyperplasia, removal of both stents, under general anesthesia, will be done after 7 to 10 days.
15899669|NCT03652272|Behavioral|EMC2|"Prescribers will receive a 'Best Practices Alert' which recommends patient counseling on medication use and provides an overview of key medication risks
~Patients will receive a Medication Guide + Summary with their After Visit Summary
~Patients will be asked to complete a brief questionnaire on medication use via the patient portal post visit (at both 1 week and 1 month post visit for this phase of the study)
~Portal assessment results and feedback will be provided to the clinic via an inbox message. Clinic staff will respond to any identified problems according to their own clinical care protocols."
15899670|NCT03652259|Genetic|SRP-9003|SRP-9003 will be administered through a single systemic injection.
15899671|NCT03652233|Drug|Nivolumab|Given by vein every 14 days for up to 12 months
15899672|NCT03652233|Drug|Afatinib|Taken by mouth daily for up to 12 months
15899673|NCT03652220|Behavioral|Meditation Based Lifestyle Modification|8 weekly modules, each 3.5 hours of Life ethics, Yoga exercises and Mantra Meditation
15899674|NCT03652220|Other|Minimal treatment|Drug continuation under medical supervision
15899675|NCT03652220|Other|Multimodal specific treatment:|Drugs / Psychotherapy / Excercise therapy / Ergotherapy / Relaxation; excl. Yoga, Mantra, MBSR
15899676|NCT03652207|Other|isomaltulose (Palatinose(TM)|isomaltulose containing food products, i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals, consumed within an energy-reduced diet
15899677|NCT03652207|Other|Sucrose|sucrose containing food products, i.e. low-fat yogurt drink, fruits drink and sweetener sachet for cereals, consumed within an energy-reduced diet
15899678|NCT03652194|Other|in vitro evaluation of epithelial immune response during C. glabrata infection|"study of the expression of genes coding for different proteins involved in the RTqPCR activation cascade
~study of protein expression by the Western-Blot method"
15899679|NCT03652194|Other|study of the impact of resistance phenotype acquisition on the virulence of C. glabrata isolates|"in vitro evaluation by measuring cell invasion, cell adhesion and by determining epithelial cell cytotoxicity.
~in vivo evaluation measured by a survival study on a CD-1 mouse model."
15899680|NCT03652168|Behavioral|Meditation|10 minute a day, 8 week digital meditation
15899681|NCT03652155|Procedure|Orthognathic surgery|Patient's pre and post operative hard and soft tissues will be evaluated retrospectively through the use of con-beam computed tomography imaging for hard tissue evaluation and 3DMd three dimensional photography for soft tissue imaging.
15899682|NCT03652142|Other|Biomarker Research|The investigators will include recurrent/metastatic HNSCC patients who progressed after cisplatin-based chemotherapy and are to be treated with nivolumab 240mg IV q 2 weeks. Patient samples will be collected with appropriate written informed consent and analyzed.
15899683|NCT03652142|Drug|Nivolumab|The investigators will include recurrent/metastatic HNSCC patients who progressed after cisplatin-based chemotherapy and are to be treated with nivolumab 240mg IV q 2 weeks.
15899684|NCT03652129|Procedure|Disinfection|Disinfection maneuver using LASER and nano irrigant
15899685|NCT03652116|Drug|Wound infiltration by Bupivacaine|Subcutaneous and subrectal infiltration with 0.25 % Bupivacaine diluted in 20 ml normal saline before closure of the wound
15899686|NCT03652116|Drug|Wound infiltration by Pethidine|Subcutaneous and subrectal infiltration with 50 mg pethidine diluted in 20 ml normal saline before closure of the wound
15899687|NCT03652103|Procedure|Ultrasound Guided Erector Spinae Plane Block Catheterisation|After receiving general anesthesia, patients will positioned prone. Before operation begins, ESP block catheter will be applied with ultrasound guidance to the same level as surgeon's incision.
15899688|NCT03652103|Drug|Bupivacaine 0.25% Injectable Solution|Perineural Injection
15899689|NCT03652090|Procedure|cell sampling|nasal brushing to collect cells
15899690|NCT03652077|Drug|INCAGN02390|Part 1: INCAGN02390 at the protocol-defined starting dose administered every 2 weeks (Q2W), with dose escalation in 7 total cohorts to determine the maximum tolerated dose or PAD.
15899691|NCT03652064|Drug|Daratumumab|Daratumumab (1800 mg) will be administered by SC injection once every week for Cycles 1 to 2, then every 3 weeks for Cycles 3-8. For Cycle 9 and beyond, participants will receive daratumumab 1800 mg SC once every 4 weeks until documented disease progression or unacceptable toxicity.
15899692|NCT03652064|Drug|Bortezomib|Bortezomib 1.3 mg/m^2 will be administered by SC injection twice weekly on Days 1, 4, 8, and 11 of each 21-day cycle for Cycles 1-8.
15899693|NCT03652064|Drug|Lenalidomide|Lenalidomide will be self-administered at a dose of 25 mg orally on Day 1 to Day 14 for Cycles 1 through 8 and on Days 1 to 21 for Cycle 9 and beyond until disease progression or unacceptable toxicity whichever occurs first.
15899699|NCT03652038|Drug|TD-8236|Study drug to be administered via inhaler device
15899700|NCT03652038|Drug|Placebo|Placebo to be administered via inhaler device
15899701|NCT03652025|Procedure|embolotherapy of incompetent gonadal and iliac veins|minimally invasive
15899702|NCT03652012|Device|Transcranial Magnetic Stimulation (TMS)|TMS in a non-invasive brain stimulation technique. In this study, we will use TMS to excite brain tissue in the motor cortex and measure the subsequent motor response in the hand. This 'intervention' will be the same in both cohorts, as we are interested in how this motor response to TMS may vary across two distinct cohorts.
15899703|NCT03651999|Other|"participation in a workshop: dream workshop animated by a nurse anesthesist"|After consultation with the pediatric surgeon or the anesthesiologist, parents and children are invited to meet the nurse, in a room dedicated to this purpose and specially designed to accommodate children; they will find a playmobil model, photographs of the patient circuit as well as different games or activities that can be performed during induction; the nurse anesthetist will take care to explain to them the progress of the hospitalization and help them to choose a pleasant dream, a perfume adapted to their taste, a distraction adapted to their age (animated book, soap bubbles, favorite song ...) ; he can customize his mask and choose the blanket he wants to take; the most recalcitrant or special sites (autism, long-term hospitalization) will be able to be accompanied by a parent during sleep
15899704|NCT03651986|Diagnostic Test|ctDNA methylation analysis by NGS|A blood-based assay for differentiating benign and malignant pulmonary nodules early using circulating tumor DNA (ctDNA) methylation analysis by next-generation sequencing (NGS)
15899705|NCT03651973|Other|Standard follow-up|Patients enrolled into standard group will be followed in a standard way without any additional procedure except randomization that allocates to the standard group
15899706|NCT03651973|Other|Learning workshops|Patients enrolled into experimental arm will participate to educative workshops before and after surgery for breast cancer. The aim of these workshop is to educate patient to self massages and self stretching.
15899707|NCT03651960|Other|ROBOT PROTOTYPE|The intervention consists of 12 45-minute sessions of balance and gait training with a mobile and interactive robot prototype for 4 weeks.
15899708|NCT03651947|Drug|QL1206|subcutaneous injection of 120 mg (1.7 ml)only once,on the first day.
15899709|NCT03651947|Drug|Xgeva®|subcutaneous injection of 120 mg (1.7 ml)only once,on the first day.
15899710|NCT03651934|Dietary Supplement|Normal iron|The intervention was divided into two stages, the first stage lasted for 4 weeks, and the dosage used was the dietary nutrient recommendation amount, namely the dietary recommendation amount standard for early pregnancy (iron 20mg/d), and the middle stage of pregnancy (iron 24mg/d). The second stage lasts for 4 weeks. For subjects in iron deficiency, the maximum tolerable amount (iron 42mg/d) is used for intervention. For those with good nutritional status, the dietary recommendation amount is maintained.
15899711|NCT03651934|Dietary Supplement|Weak iron|The intervention was divided into two stages, the first stage lasted for 4 weeks, and the dosage used was the dietary nutrient recommendation amount, namely the dietary recommendation amount standard for early pregnancy (iron 20mg/d), and the middle stage of pregnancy (iron 24mg/d). The second stage lasts for 4 weeks. For subjects in iron deficiency, the maximum tolerable amount (iron 42mg/d) is used for intervention. For those with good nutritional status, the dietary recommendation amount is maintained.
15899712|NCT03651934|Dietary Supplement|Normal selenium|The intervention was divided into two stages, the first stage lasted for 4 weeks, and the dosage used was the dietary nutrient recommendation amount, namely the dietary recommendation amount standard for early pregnancy (selenium 60ug/d), and the middle stage of pregnancy (selenium 65ug/d). The second stage lasts for 4 weeks. For subjects in selenium deficiency, the maximum tolerable amount (selenium 400ug/d) is used for intervention. For those with good nutritional status, the dietary recommendation amount is maintained.
15899713|NCT03651934|Dietary Supplement|Weak selenium|The intervention was divided into two stages, the first stage lasted for 4 weeks, and the dosage used was the dietary nutrient recommendation amount, namely the dietary recommendation amount standard for early pregnancy (selenium 60ug/d), and the middle stage of pregnancy (selenium 65ug/d). The second stage lasts for 4 weeks. For subjects in selenium deficiency, the maximum tolerable amount (selenium 400ug/d) is used for intervention. For those with good nutritional status, the dietary recommendation amount is maintained.
15899714|NCT03651921|Behavioral|CTS-BC-CH|"CTS-BC-CH is a standardized program with 7 weekly group sessions (2.5. to 3 hours). The CTS-BC-CH focuses on building skills, sharing experiences, and support among the participants.
~Program elements are: Brainstorming, action plan formulation, action plan feedback, problem solving, and decision making."
15899715|NCT03651908|Procedure|Conventional Flap Surgery|"After administering local anaesthetic a full thickness flap will be raised and reflected to expose the intrabony defects.The intrabony defects would then the debrided and grafts secured in position.Later the flap would be sutured back.
~After administering local anaesthetic a full thickness flap will be raised and reflected to expose the intrabony defects.The intrabony defects would then the debrided and grafts secured in position.Later the flap would be sutured back."
15899716|NCT03651895|Drug|Metformin|Drug
15899717|NCT03651895|Drug|Placebo|Placebo
15899718|NCT03651882|Drug|Oxytocin|Oxytocin given in a combined regimen: after delivery 10 IE of oxytocin are applied intramyometrially and 10 IE of oxytocin are given over an infusion of 1000ml of 0.9% NaCL over 12 hours intravenously.
15899719|NCT03651882|Drug|Carbetocin|Carbetocin is given 0.1mg intravenously as a bolus after delivery.
15899720|NCT03651869|Drug|Cigarette 1|Cigarette containing between 0mg nicotine and the conventional amount of nicotine (0.8mg)
15899721|NCT03651869|Drug|Cigarette 2|Cigarette containing between 0mg nicotine and the conventional amount of nicotine (0.8mg)
15899722|NCT03651869|Drug|Patch 1|A patch containing between 0mg nicotine and the conventional amount of nicotine (21mg)
15899723|NCT03651869|Drug|Patch 2|A patch containing between 0mg nicotine and the conventional amount of nicotine (21mg)
15899724|NCT03651856|Drug|ATM FOG in PD|open label pilot study on atomoxetine 40mg BID on patients with Parkinson's disease and Freezing of Gait
15899725|NCT03651843|Other|Questionnaire|Women who have recently given birth in the Lille metropolitan area fill in a self-administered questionnaire asking them about their perception of occupational risk during pregnancy and their knowledge of their right to work during pregnancy.
15899870|NCT03650764|Other|EORTC QLQ-30|-Screening, start of cycle 2, start of cycle 5
15899726|NCT03651830|Device|Prosthetic Foot Emulator|Participants will walk in the laboratory with the Prosthetic Foot Emulator (PFE) in three foot modes corresponding to actual study feet. Walking conditions will include self-selected speed, slow speed, fast speed, incline, and up stairs.
15899727|NCT03651830|Device|Commercially available prosthetic feet|"Participants will walk in the laboratory with three different commercially available prosthetic feet. Walking conditions will include self-selected speed, slow speed, fast speed, incline, and up stairs.
~Additionally, participants will be fit with one of the actual feet and wear it at home and in the community for approximately two weeks. This will be followed by two-week periods in the community with each of the other two commercially available prosthetic feet."
15899728|NCT03651817|Device|Mechanical ventilation|Patients will be ventilated with anesthesia machine according to the group they belong to
15899729|NCT03651804|Procedure|Radiofrequency ablation of the medial branch nerves|A radiofrequency ablation (RFA) is a procedure in which a heat lesion via a needle is created on the nerve that transmits the pain signal in order to interrupt the brain to interrupt the painful signal to the brain. We will target the medial branch nerves.
15899730|NCT03651804|Drug|Non-steroidal anti-inflammatory drugs|Some of the most commonly used pain medicines in adults. NSAIDs block proteins, called enzymes, in the body that play a role in pain and inflammation. They include aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), and many other generic and brand name drugs.
15899731|NCT03651804|Drug|Bisphosphonates|A class of drugs that prevent the loss of bone density and are used to treat osteoporosis and similar diseases.
15899732|NCT03651804|Drug|Acetaminophen|A medicine used to treat pain and fever. It is typically used for mild to moderate pain relief. Commonly known as Tylenol.
15899733|NCT03651804|Behavioral|Physical therapy|Physical Therapy.
15899734|NCT03651804|Drug|Opioids|Opioids are narcotics that act on opioid receptors to produce morphine-like effects and medically they are primarily used for pain relief.
15899735|NCT03651791|Combination Product|USPIO labeled MSC injection|USPIO labeled MSC injection
15899736|NCT03651765|Drug|Setmelanotide|Once daily subcutaneous injection
15899737|NCT03651752|Drug|Diphenylcyclopropenone (DPCP) Ointment|All subjects will be administered a sensitization dose of 0.05 mL 0.4% DPCP ointment formulation topically in the inner aspect of the upper right arm at Day -16, and 0.05 mL of four concentrations (0.1, .05, 0.01, 0.005%), prepared through dilutions in the ointment vehicle, topically on the inner aspect of the left thigh at Day -2. The weakest strength that may cause a minimal reaction (DTH skin reaction score of 1+) after two days will be chosen, and 0.75-1 g of that concentration will be applied to the scalp starting at Week 1 and administered subsequently twice a week for 18 weeks
15899738|NCT03651739|Device|Knee Connect|An electronic goniometer with smart phone application
15899739|NCT03651726|Drug|THX-110 (dronabinol plus PEA)|2.5 mg dronabinol capsules and 400 mg PEA tablets
15899740|NCT03651726|Drug|Placebo|Sesame oil pill manufactured to mimic 2.5 mg dronabinol capsules; cellulose pill manufactured to mimic 400 mg PEA tablets
15899741|NCT03651713|Behavioral|GLU+EX|Subjects will complete 45 minutes of recumbent cycling at 60-65% of age-predicted maximal heart rate five times over seven days while ingesting a 75g glucose beverage three times daily.
15899742|NCT03651713|Dietary Supplement|GLU|Subjects will consume a 75g glucose beverage three times daily over a seven-day period.
15899743|NCT03651700|Device|Active TMS|Active TMS will be at 90% motor threshold
15899744|NCT03651700|Device|Sham TMS|Sham TMS will be administered
15899745|NCT03651700|Behavioral|CILT|60-90 minutes of CILT will be administered during each treatment session
15899746|NCT03651674|Device|ECT treatment|Patients had bilateral temporal modified ECT four times a week for 3 consecutive weeks
15899747|NCT03651674|Drug|Drug treatment|Patients only have antipsychotic drugs
15899748|NCT03651661|Drug|human insulin|human insulin administered as nasal spray
15899749|NCT03651661|Drug|placebo|placebo administered as nasal spray
15899750|NCT03651661|Diagnostic Test|Pupillography|Autonomic tone will be adressed by pupillography using the F2D2 (Amtech Germany) device.
15899751|NCT03651648|Device|SENSITACT System|the activated stimulation (ON period of 6 hours) will be hidden from the care team, who will continue the care according to the usual procedures (blind treatment).
15899752|NCT03651648|Device|SENSITACT System|the desactivated stimulation (OFF period of 6 hours) will be hidden from the care team, who will continue the care according to the usual procedures (blind treatment).
15899753|NCT03651635|Diagnostic Test|Blood sampling for MR-proADM & CT-proET-1|Collection of at most 8 blood samples (3ml each) per Patient admitted to the study and sampling for MR-proADM & CT-proET-1
15899754|NCT03651622|Behavioral|Hypocaloric, low carbohydrate diet|Participants will be advised on use of a hypocaloric, low carbohydrate diet using lifestyle counseling to include motivational interviewing and problem solving skills training strategies.
15899755|NCT03651622|Behavioral|Hypocaloric, moderate low fat diet|Participants will be advised on use of a hypocaloric, moderate low fat diet using lifestyle counseling to include motivational interviewing and problem solving skills training strategies.
15899756|NCT03651622|Behavioral|Mediterranean diet, no caloric restriction|Participants will be advised on use of a healthy Mediterranean-based eating plan using lifestyle counseling to include motivational interviewing and problem solving skills training strategies.
15899757|NCT03651609|Procedure|Simple decompression of the ulnar nerve|Surgical HUA release 2-3 cm distal to medial epicondyle with minimal-incision technique .
15899758|NCT03651609|Behavioral|Conservative treatment|Patients will be given pictured recommendations with descriptions, which limb positions should be avoided.
15899759|NCT03651596|Behavioral|mHealth Messaging Intervention Group|The newly developed intervention messages will be sent to individuals assigned to the intervention group during the study.
15899760|NCT03651596|Behavioral|Standard mHealth Messaging Group|Standard mHealth messages will be sent to individuals assigned to the active control group during the study.
15899761|NCT03651583|Behavioral|Kiko exercises-combines breathing and movement|
15899762|NCT03651570|Device|PTSD Coach|PTSD Coach is a mobile mental health app that addresses the issue of mental health and stigma which can be used as a stand-alone education and symptom management and contains 4 modules: 1) Learn- Module, 2) Self- Assessment-Module, 3) Manage Symptoms-Module and 4) Find Support-Module.
15899871|NCT03650764|Other|FACT H&N|-Screening, start of cycle 2, start of cycle 5
15899763|NCT03651570|Behavioral|Game application|This control condition is important to control for distraction (attention on something pleasant or a task) and the human factor involved in usage prompting (i.e., same exposure time + contacts with personnel), since either distraction or the human contact with staff may, alone, lower anxiety
15899764|NCT03651557|Drug|Neu2000KWL High-dose group|1st infusion of 1500mg in patients within 4 hours following sudden cardiac arrest onset followed by 5 consecutive infusions of 750 mg at intervals of 12 hours(Total drug dosage is 5250mg.)
15899765|NCT03651557|Drug|Neu2000KWL Low-dose group|1st infusion of 750mg in patients within 4 hours following sudden cardiac arrest onset followed by 5 consecutive infusions of 500 mg at intervals of 12 hours (Total drug dosage is 3250mg.)
15899766|NCT03651557|Drug|Placebo|1st infusion of the same volume of saline in patients within 4 hours following sudden cardiac arrest onset followed by 5 consecutive infusions of the same volume of saline at intervals of 12 hours
15899767|NCT03651544|Biological|GamFluVac|1 dose (0,5 ml)
15899768|NCT03651531|Drug|Insulin|Weight based insulin will be calculated using 0.7 units/kg/day in the first trimester, 0.8 units/kg/day in the second trimester and 1 units/kg/day in the third trimester. This total insulin will then be divided into short acting insulin and intermediate acting insulin per provider discretion.
15899769|NCT03651531|Drug|Metformin|Will be initiated at dose of 500 mg twice daily. If glycemic control is suboptimal, the dose of metformin will be increased to 1000 mg twice a day. Metformin will be titrated prior to increases in insulin.
15899770|NCT03651518|Drug|Kineret|100 mg, once/day sc 6 months
15899771|NCT03651518|Drug|Humira|40 mg/15 days sc 6 months
15899772|NCT03651518|Drug|Stelara|45 mg/12 weeks sc, 6 months
15899773|NCT03651518|Drug|Cosentyx|300mg sc every week for 1 month, then 300 mg/month sc for 5 months
15899774|NCT03651518|Drug|Roactemra|480 mg/perf/4 weeks 6 months
15899775|NCT03651518|Drug|Rituximab|2 sessions of 1000 mg at inclusion and 15 days after inclusion
15899776|NCT03651505|Other|No intervention|Access to any treatment is through authorized commercial use and not as a part of this DMP
15899777|NCT03651492|Behavioral|questionnaire administration|All the patients will be administered the Pittsburgh Questionnaire after completion of ABPM.
15899778|NCT03651479|Other|real boxing training|In the real boxing (RB) group in addition to the NDT program, real boxing training will be given. Accordingly, the physiotherapist and the patient will wear boxing gloves and the patients will punch the physiotherapist's glove with a pre-specified treatment protocol. Resistance and frequencies between levels will be increased by the physiotherapist as the sessions progress. The RB group will have 30 minutes of real boxing training for 3 sessions per week for 8 weeks.
15899779|NCT03651479|Other|virtual boxing training|In the virtual boxing (VB) group, in addition to the NDT program, virtual boxing training will be given by using Kinect Xbox Boxing. For the VB group, virtual boxing training will be held for 3 weeks 30 minutes a week for 8 weeks.
15899780|NCT03651466|Drug|Gx-G6|Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.
15899781|NCT03651466|Drug|Placebo|Each subject will receive a single dose of either GX-G6 or placebo in randomized fashion.
15899782|NCT03651453|Behavioral|Decision aid|Participants in the experimental arm will receive the PrEP decision aid.
15899783|NCT03651453|Behavioral|Standard care|Standard harm reduction information
15899784|NCT03651440|Other|PNF|PNF
15899785|NCT03651440|Other|lumbar stabilization training|lumbar stabilization training
15899786|NCT03651440|Other|Physical Therapy|Physical Therapy
15899787|NCT03651440|Other|Control|Control group
15899788|NCT03651427|Drug|Estradiol|Induced hypogonadism and re-institution of CSHT
15899789|NCT03651414|Other|Clinical data collection|There will not be any experimental intervention. The study will be conducted according with normal clinical practice.
15899790|NCT03651401|Device|Scapular muscle endurance test|The SME test, developed by Edmondston et al. 17, is based on an exercise used to improve the performance of the serratus anterior and trapezius muscles. The test was carried out while the subjects were facing the wall in standing position and with their shoulders and elbows flexed to 90 degrees. While both scapulae were in neutral position, an appropriate size of stick (18-36 cm) was selected and placed between the elbows, and they were asked to hold the dynamometer (Feta 137 F0202 1 kg/10 N) between their hands.
15899791|NCT03651401|Other|Pain intensity|"Pain intensity assessment was performed by questioning rest, activity, night, and measuremant pain using a visual analogue scale (VAS) on a 10 cm line with marks at both ends to define the limits of the pain experience as no pain (0) and maximum pain experienced (10), with higher scores indicating greater pain 20."
15899792|NCT03651401|Device|Upper Limb Functional Performance|The Functional Impairment Test-Hand and Neck/Shoulder/Arm (FIT-HaNSA) protocol, which was developed by MacDermid et al. 21, was used to evaluate the functional performance of the upper extremity when performing 3 tasks.
15899793|NCT03651375|Drug|Sequential chemotherapy - 3 courses of AI|Three courses of doxorubicin and ifosfamide (AI, doxorubicin 75 mg/sqm and ifosfamide 10 g/sqm with prophylactic mesna), one before radiotherapy and two within the gap between radiotherapy and surgery.
15899794|NCT03651375|Radiation|Hypofractionated radiotherapy|Preoperative hypofractionated 5x5 Gy radiotherapy (5 consecutive days) prescribed on planned target volume (tumor volume + elective margins + setup/error margin) with a daily image guidance with cone beam-CT-based position verification.
15899795|NCT03651349|Drug|HK-001|HK-001 is synthesized by PharmaCore Biotech Co., Ltd. Synthetic (Z)-BP with high purity will be used in this proposed study.
15899796|NCT03651349|Drug|Placebo control|In order to evaluate the safety and tolerability of HK-001 more accurately, a drug-free placebo control is planned to be utilized for the same administration route in this proposed trial. The placebo control that is identical in appearance, smell, weight, and excipients will be supplied by Everfront Biotech Inc.
15899797|NCT03651336|Device|ARGOS-IO Sensor Pressure System|The ARGOS-IO Pressure sensor have been additionally implanted during local routine working procedures for cataract surgery in Patients with Primary Open Angle Glaucoma (POAG) and indicated cataract surgery in previous studies ARGOS-01 and ARGOS-02
15899798|NCT03651323|Device|Left atrial appendage closure with Watchman device|Percutaneous left atrial appendage closure using Watchman device
15899799|NCT03651310|Other|Music Listening Group|Waiting in preoperative area with music listening.
15899872|NCT03650764|Procedure|Peripheral blood|-Baseline
15899800|NCT03651297|Other|Balance training with Fall-Arrest harness|This study will analyze the subjects' responses to balance training protocols with two types of harness support. The protocol will involve balance training, initially of low intensity and then advanced by an algorithm based on subjects' responses to the prior repetition of balance activity. For this intervention, the subjects will be using a standard Fall-Arrest harness for safety throughout, but no other external support. This will allow comparison of postural control, slip responses, motor learning, reliance on the harness and confidence with the system between the two harness types.
15899801|NCT03651297|Other|Balance training with Adjustable harness|This study will analyze the subjects' responses to balance training protocols with two types of harness support. The protocol will involve balance training, initially of low intensity and then advanced by an algorithm based on subjects' responses to the prior repetition of balance activity. For this intervention, the subjects will be using a motorized harness in which the support provided is adjustable. This will allow comparison of postural control, slip responses, motor learning, reliance on the harness and confidence with the system between the two harness types.
15899802|NCT03651284|Behavioral|Aim2Be app with Live Coach + Fitbit + BMI tracking tools|Participants will spend six months using the Aim2Be app setting aims, completing tasks, accessing articles, doing self-assessments, and participating in the social wall. They will also complete a series of questionnaires, dietary recalls, BMI tracking using scales and tape measures, and physical activity tracking using Fitbits. Participants in this condition will have access to the Live Coach and the Virtual Coach. The Live Coach has specialized training in lifestyle and motivational interviewing and will support families in changing their health behaviours through in-app messaging and phone calls. The Virtual Coach gives guidance to families through an avatar that has been programmed using motivational interviewing theory.
15899803|NCT03651284|Behavioral|Aim2Be app waitlist + Canadian Health Recommendations + Fitbit + BMI tracking tools, then flip to Aim2Be app with Virtual Coach + Fitbit + BMI tracking tools|Participants in this condition will be waitlisted for three months while they receive standard of care (Canadian Health Recommendations for physical activity, dietary habits, screen behaviours, and sleep). Participants will gain access to the Aim2Be app with Virtual Coach after the three month assessment. Participants will then spend three months using the Aim2Be app setting aims, completing tasks, accessing articles, doing self-assessments, and participating in the social wall. For the whole six months, participants will complete a series of questionnaires, dietary recalls, BMI tracking using scales and tape measures, and physical activity tracking using Fitbits. Participants in this condition will have access to the Virtual Coach only. The Virtual Coach gives guidance to families through an avatar that has been programmed using motivational interviewing theory.
15899804|NCT03651271|Biological|Nivolumab Monotherapy|Single-agent nivolumab will be administered at 360 mg IV Q3W. Participants who continue to show clinical benefit after the first disease assessment will receive nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
15899805|NCT03651271|Biological|Nivolumab and Ipilimumab and Combination for Metastatic Cancer|For nivolumab and ipilimumab combination therapy, nivolumab will be administered at 360 mg IV Q3W, and ipilimumab will be administered at 1 mg/kg IV Q3W for the first 2 doses and then Q6W for the 3rd and 4th doses, followed by single-agent nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
15899806|NCT03651271|Biological|Nivolumab and Ipilimumab (3 mg/kg) Combination for Prostate Cancer|For nivolumab and ipilimumab combination therapy, CD8 low arm will be randomly allocated into 1 of 2 cohorts, using different doses of ipilimumab administered in 6-week cycles. Prostate Cohort A will receive nivolumab 1 mg/kg Q3W and ipilimumab 3 mg/kg every 6 weeks (Q6W) for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity.
15899807|NCT03651271|Biological|Nivolumab and Ipilimumab (5 mg/kg) Combination for Prostate Cancer|For nivolumab and ipilimumab combination therapy, CD8 low arm will be randomly allocated into 1 of 2 cohorts, using different doses of ipilimumab administered in 6-week cycles. Prostate Cohort B will receive nivolumab 1 mg/kg Q3W and ipilimumab 5 mg/kg Q6W for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity.
15899808|NCT03651258|Behavioral|Implementation of ALIJEU|"The intervention concerns the passage from the passive feed (gastric tube) to the active feed (breast, feeding bottle).
~We propose to set up a pleasant moment just before his meal. This is a practical exercise of a few minutes.
~The aim of this special moment is to facilitate child-adult exchanges, improve active food intake and reduce the length of hospital stay."
15899809|NCT03651232|Behavioral|yoga|once weekly group yoga class for 12 weeks
15899810|NCT03651232|Behavioral|support group|once weekly group support class for 12 weeks
15899811|NCT03651219|Drug|Apatinib|Apatinib Mmesylate tablets 250mg/d, po, there's totally 4-6 cycles(21days per cycle)
15899812|NCT03651219|Drug|Irinotecan|Irinotecan 80mg/m2 d1, d8, vi, there's totally 4-6 cycles(21days per cycle)
15899813|NCT03651206|Drug|Niraparib|PARP Inhibitor
15899814|NCT03651206|Combination Product|Niraparib + TSR-042 (Dostarlimab)|Combination of 2 drugs, a PARP Inhibitor and an Anti-PD-1
15899815|NCT03651206|Drug|Chemotherapy Drugs|Chemotherapies given in standard of care
15899816|NCT03651193|Diagnostic Test|Exon sequencing and Methylated sequencing|Exon sequencing and Methylated sequencing
15899817|NCT03651167|Other|Survey|Participants will complete a survey online
15899818|NCT03651154|Procedure|Hypovolemic Phlebotomy|Removal of 7-10ml/kg of blood from participant, as tolerated after patient is under anesthesia, before liver resection start time
15899819|NCT03651141|Other|Neurodynamic Sliding|Subjects in the neurodynamic sliding group perform 2 movements; 1) movement 1 involves sitting on the edge of the treatment table the bringing their neck to their chest along with bending their knee and pointing their ankle to the ground. Movement 2 is performed by facing their head towards the ceiling and straightening their knee while pointing their ankle towards their nose. Subjects will alternate these 2 active movements for 60s and repeated 5 times, with rest period of 15s between sets. A metronome will be set at 30 beats per minute for 15 full slides per minute to standardize the amount of slides per session.
15899820|NCT03651141|Other|Myofascial Decompression|For the group receiving the cupping treatment, the subject will lay on their stomach and their affected hamstring will be exposed. Cocoa butter will be applied to the hamstring prior to the application of the cups. 5 cups will be placed along the hamstring and calf muscles. Using a handheld suction pump, each cup will be pumped so that skin fills up half of the cup. The cups will stay in place for five minutes and the clinician will instruct the subject to perform 5 repetitions of active quad sets and 5 repetitions of ankle pumps .
15899821|NCT03651141|Other|Diathermy|The control group will receive a sham heat (diathermy treatment). The subjects will be asked to sit and relax for five minutes and the machine will not be turned on with a timer timing the treatment.
15899822|NCT03651128|Biological|bb2121|bb2121
15899823|NCT03651128|Drug|Daratumumab|Daratumumab
15899824|NCT03651128|Drug|Pomalidomide|Pomalidomide
15899825|NCT03651128|Drug|Dexamethasone|Dexamethasone
15899826|NCT03651128|Drug|Bortezomib|Bortezomib
15899827|NCT03651128|Drug|Ixazomib|Ixazomib
15899828|NCT03651128|Drug|Lenalidomide|Lenalidomide
15899829|NCT03651128|Drug|Carfilzomib|Carfilzomib
15899830|NCT03651128|Drug|Elotuzumab|Elotuzumab
15899831|NCT03651115|Diagnostic Test|therapeutic drug monitoring|To monitor the blood concentrations of gentamicin and vancomycin
15899832|NCT03651102|Drug|Thalidomide Oral Product|Dosage: 1-3mg/kg/day
15899833|NCT03651089|Drug|SP16|subcutaneous injection of experimental anti-inflammatory drug
15899834|NCT03651089|Drug|Placebos|subcutaneous injection of sterile saline
15899835|NCT03651076|Device|Traxi panniculus retraction (Clinical Innovations, LLC)|class I, FDA-exempt, commercially available for use in panniculus retraction during cesarean delivery or other laparotomy
15899836|NCT03651063|Other|social robot|Reach To Grasp games with a social robot
15899837|NCT03651063|Other|computer group|reach to grasp games with a computer screen
15899838|NCT03651063|Other|self-training|reach to grasp games with no externa feedback.
15899839|NCT03651050|Behavioral|Faith Based Outreach (FBO)|Faith base outreach groups will be trained in P-MHDT
15899840|NCT03651050|Behavioral|community-health-workers (CHW)|COmmon health workers will be trained in P-MHDT
15899841|NCT03651037|Behavioral|Thrivors+BH|Digital health platform for breast cancer patients that measures adherence and engagement.
15899842|NCT03651024|Device|ED surgery|The surgical implant for ED treatment
15899843|NCT03651011|Drug|Aflibercept Injection [Eylea]|Intravitreal injection 2 mg Eylea every 4 weeks M0-M2 (loading phase). M3-M12: continue in a pro re nata treatment regimen.
15899844|NCT03651011|Procedure|Navigated laser photocoagulation|Navigated laser photocoagulation planned from flourscein angiography.
15899845|NCT03650998|Drug|Ropivacaine|See arm description
15899846|NCT03650998|Drug|Saline|See arm description
15899847|NCT03650985|Procedure|Fetoscope technique|Intrauterine intervention with fetoscope technique will be applied to treat complex twin diseases with intention to improve the prognosis of patients.
15899848|NCT03650972|Other|Samarin|Arm: Active Comparator: B, Bicarbonate group When labour arrest is diagnosed and the first AFL > 12 mmol/L the participants will be randomized to two groups. In group B the participant will drink bicarbonate (2 packages of Samarin®) dissolved in 200 ml of water. Then after one hour the AFL will be measured again and the stimulation with oxytocin will be started if there is no progress in the cervix.
15899849|NCT03650959|Other|Method of learning simple interrupted sutures with instrument tie|Students will train to proficiency (defined by hand motion analysis) on simple interrupted sutures with an instrument tie via one of three different methods: faculty-led, peer tutor-led, or computer augmented self-directed learning.
15899850|NCT03650946|Diagnostic Test|Ga-68 PSMA PET|Ga-68 PSMA PET
15899851|NCT03650933|Biological|G-CHOP|6 cycles(each cycle is 3 weeks)
15899852|NCT03650933|Biological|R-CHOP|6 cycles(each cycle is 3 weeks)
15899853|NCT03650920|Procedure|Liver Transplantation|A HCV negative or previously successfully treated recipient with a HCV positive liver graft
15899854|NCT03650907|Behavioral|Group exercise program|"Patients in experimental group attend group exercise program, instructed by fitness trainer, at long-term care institutions.
~Frequency: 3 times per week. Type: resistance/flexibility/balance training, including warm-up and cold-down. Duration: 1 hour per time, for 16 weeks."
15899855|NCT03650907|Behavioral|Self exercise program|Patients in control group receive oral education for self exercise program, mainly resistance muscle training. Patients are requested to do self-training for 16 weeks.
15899856|NCT03650894|Drug|Nivolumab|Nivolumab 240 mg IV every 2 weeks
15899857|NCT03650894|Drug|Ipilimumab|Ipilimumab 1 mg/kg IV every 6 weeks.
15899858|NCT03650894|Drug|Bicalutamide|Oral bicalutamide 150mg (3 x 50mg tablets) daily
15899859|NCT03650881|Drug|Neutrogena ® Light Therapy Acne Mask (MASK)|Daily use of the OTC Neutrogena Light Therapy Acne Mask once daily for 10 minutes
15899860|NCT03650881|Drug|Topical OTC benzoyl peroxide 2.5% gel and OTC adapalene|Daily treatment with Reference Therapy OTC topical generic benzoyl peroxide 2.5% gel in the morning and OTC generic adapalene 0.1% gel at night
15899861|NCT03650868|Procedure|Thoracal paravertebral block|Thoracal paravertebral block will be performed before the surgery to the TPVB group.
15899862|NCT03650842|Device|Near infrared spectroscopy (NIRS)|One monitor will be placed on the forehead to measure cerebral oxygenation and a second over the lower back to measure tissue (muscle or renal) oxygenation.
15899863|NCT03650816|Other|Doppler ultrasonography|Blood flow measurement in in the internal and common carotid arteries during the 10th minute of inhalation of a gas mixture containing 5% CO2, 16% O2 and 79% N2, compared to the baseline blood flow value measured after 10 minutes rest in lying position.
15899864|NCT03650816|Other|Biospecimen collection|Blood: ET-1, bigET-1, ADMA plasma concentration; plasma renin activity
15899865|NCT03650803|Device|3D MR Fingerprinting scan|"3D MR Fingerprinting technique is a non-contrast technique and generates quantitative information about MR-visible tumors without having to administer contrast.
~MR Fingerprinting software is used in conjunction with a standard-of-care MRI scan."
15899866|NCT03650790|Diagnostic Test|Blood test|For serum analysis, approximately 2 cc antecubital vein venous blood serum will be taken from each patient to be studied for CTRP9 Level analysis. Adult blood will be centrifuged at 4000 rpm for 10 minutes to separate greenhouses. The obtained serum samples will be stored at -80 ° C until analysis.
15899867|NCT03650777|Other|Warfarin Telehealth Education|Patients received education on warfarin through a video on an iPad, and were assessed on knowledge pre and post video, and at follow up visit
15899868|NCT03650764|Drug|Ramucirumab|Ramucirumab is an investigational agent for this trial and will be supplied by Lilly Oncology, free of charge to the patient
15899869|NCT03650764|Drug|Pembrolizumab|Pembrolizumab is commercially available
15899873|NCT03650751|Other|Nursing observation indexes|It provides nursing staff with a unified reference standard for nursing observation indicators and sets monitoring and warning values according to the score, which is helpful to improve the timeliness and accuracy of nursing observation for patients with cerebral apoplexy.
15899874|NCT03650738|Drug|Apatinib|Neoadjuvant program: apatinib 250mg oral d1-21; albumin paclitaxel 260mg/m2 intravenous drip d1; carboplatin AUC=5-6 intravenous drip d1; 21 days for 1 cycle. The treatment regimen was used for a total of 6 cycles, or to PD, or the toxicity was not tolerated.
15899876|NCT03650712|Diagnostic Test|Oral glucose tolerance test|oral glucose solution is given by mouth, blood is drawn prior to the administration of the oral glucose beverage and then at timed intervals afterward. This is the standard test to diagnosis cystic fibrosis related diabetes mellitus. However, this study will have more time points than standard screening for cystic fibrosis related diabetes mellitus
15899877|NCT03650712|Diagnostic Test|Continuous glucose monitoring|a device is placed on the subject's arm that continuously monitors subcutaneous glucose levels for up to 10 days
15899878|NCT03650712|Diagnostic Test|Dexa scan|low dose x-rays are used to measure the subject's bone density. This is the standard test to diagnose osteoporosis
15899879|NCT03650699|Device|Electropalatography Biofeedback Training|The study agent is electropalatography (EPG). The LinguaGraph EPG device is a biofeedback technology that creates a digital visualization of tongue function during speech. The visualization is accomplished by a custom made mouthpiece that fits over the hard palate with 62 sensors that capture tongue position. The information from the sensors in the mouthpiece, as well as the audio output, is processed in an EPG Unit that converts the information from mouthpiece to a visual representation on a computer screen. The visual information with respect to tongue position can be used to provide biofeedback training.The computer can be used in the clinic during a patient visit or it can be seen over the internet with the patient at home and the speech and language pathologist at the clinic.
15899880|NCT03650686|Other|Food weighing (gold standard)|Method which consists in weighing precisely the main dish at the beginning and then end of meal using a SOEHNLE scale (+/- 1g).
15899881|NCT03650686|Other|Automated photographic method (method to be evaluated)|The nursing staff will position the tray for automatic picture taking before and after the meal. Taking a photograph of the entire tray will allow the patient's identity to be identified by his meal card which will then be coded for analysis and the plate will be targeted at the time of the nutritional analysis by the software. This method will automatically provide the percentage of each main dish food consumed using an advanced image processing algorithm and an optimized artificial intelligence system that will recognize the food before and after consumption. Automatic processing and transfer will enable food intake to be collected.
15899882|NCT03650686|Other|Semi-quantitative method (routine method)|Staff will indicate whether 1, ¾, ½, ¼ or 0 (corresponding to 100%, 75%, 50% 25% or 0) of the food in the main course has been consumed.
15899883|NCT03650673|Diagnostic Test|Identification of subgroups of patients with early AD with risk of progression|Clinical examination with questionnaires, Biological collection, Imaging (radiography, densitometry, ultrasound, and MRI)
15899884|NCT03650660|Other|Trans-thoracic ultrasound|Trans-thoracic ultrasound performed by an expert and a non-expert
15899885|NCT03650647|Procedure|Carious dentin removal|Carious tissue removal and managing deep cavitated carious lesions in primary teeth.
15899886|NCT03650621|Device|Magnetic acupuncture|5 magnetic acupuncture stickers will be placed on the infants ear
15899887|NCT03650621|Device|stickers (magnets removed)|in this group 5 stickers (magnets removed) will be placed on the infants ear
15899888|NCT03650608|Drug|Cohort 1: HL217 Ophathalmic Solution QD|Cohort 1 (Once a day)
15899889|NCT03650608|Drug|Cohort 2: HL217 Ophathalmic Solution BID|Cohort 2 (Twice a day)
15899890|NCT03650608|Drug|Cohort 3: HL217 Ophthalmic Solution QID|Cohort 3 (Four times a day)
15899891|NCT03650608|Drug|Placebo Ophthalmic solution|Placebo
15899892|NCT03650595|Device|"The TRANBERGCLS|Thermal Therapy"|"MRI Guided Focal Laser Ablation of Prostate Cancer by The Diode Laser System - The TRANBERGCLS|Thermal Therapy"
15899893|NCT03650582|Drug|Glucagon|Intranasal glucagon
15899894|NCT03650582|Drug|Placebo|Intranasal placebo
15899895|NCT03650556|Device|TactiCath™ Contact Force Ablation Catheter, Sensor Enabled™|Ablation procedure for Persistent AF
15899896|NCT03650543|Drug|amoxicillin clarithromycin omeprazole 1|Patients in this received triple standard therapy for eradication of H.pylori with standard doses of proton pump inhibitor (omeprazole), in combination with amoxicillin and clarithromycin in absence of antibiotic resistance.
15899897|NCT03650543|Drug|amoxicillin clarithromycin omeprazole 2|The treatment for patients in this group was prescribing triple standard therapy for H.pylori eradication with amoxicillin and clarithromycin in absence of antibiotic resistance but with different doses of proton pump inhibitor (omeprazole) according to CYP2C19 genotype in each patients.
15899898|NCT03650530|Other|The Family Talk Intervention|The family meets two interventionists at six time points.
15899899|NCT03650517|Procedure|Extracorporeal Anastomosis|Anastomosis is performed by pulling out the bowel through a laparotomy wherever that laparotomy is performed.
15899900|NCT03650517|Procedure|Intracorporeal Anastomosis|Anastomosis is performed inside the abdominal cavity with a laparoscopic or robotic technique
15899901|NCT03650517|Procedure|Robotic Surgery|Procedure is performed using robotic instruments
15899902|NCT03650517|Procedure|Laparoscopic Surgery|Procedure is performed using standard laparoscopic instruments
15899903|NCT03650504|Procedure|Above Artery Catheter Placement|Nerve catheter placed between superficial femoral artery and sartorial muscle
15899904|NCT03650504|Procedure|Between Artery and Vein Placement|Nerve catheter placed between superficial femoral artery and femoral vein
15899905|NCT03650491|Drug|FOR46|FOR46 is an intravenously (IV) administered antibody-drug conjugate (ADC) directed against CD46
15899941|NCT03650166|Other|Personal BP monitor|Battery-powered BP monitor for personal use
15899942|NCT03650153|Procedure|Trans-rectal MRI targeted Biopsy|Trans-rectal biopsy of the prostate: A procedure in which a sample of tissue is removed from the prostate using a thin needle that is inserted through the rectum and into the prostate.
15899906|NCT03650478|Device|NeuroPAP ventilation (2h) and NeuroBox monitoring (23h)|Patients will be successively ventilated with conventional NIV (30 min with the conventional ventilator, 30 min with the NeuroBOX), and NeuroPAP (1 hour). An additional 20-hour period of recordings (with conventional NIV) will be conducted to characterize the neural breathing pattern, prevalence of apneas and tonic activation during conventional treatment. Finally, a second 1-hour period with NeuroPAP will be conducted
15899907|NCT03650478|Device|NeuroPAP ventilation (4h) and NeuroBox monitoring (25h)|Patients will be successively ventilated with conventional NIV (30 min with the conventional ventilator, 30 min with the NeuroBOX), and NeuroPAP (3 hours). An additional 20-hour period of recordings (with conventional NIV) will be conducted to characterize the neural breathing pattern, prevalence of apneas and tonic activation during conventional treatment. Finally, a second 1-hour period with NeuroPAP will be conducted
15899908|NCT03650465|Behavioral|Cognitive-behavioral therapy (CBT)|Cognitive-behavioral therapy (CBT)
15899909|NCT03650452|Drug|TAK-935|TAK-935 tablets or mini-tablets.
15899910|NCT03650452|Drug|Placebo|TAK-935 placebo-matching tablets or mini-tablets.
15899911|NCT03650439|Diagnostic Test|culture on Sabouraud's Dextrose Agar (SDA)|• Clinical samples will be cultured onto Sabouraud's Dextrose Agar (SDA) plates supplemented with chloramphenicol. the culture was incubated at 25 C° and at 37° C (for yeasts and moulds isolation )
15899912|NCT03650426|Procedure|Total knee with onlay patellar resurfacing technique|The patellar resurfacing technique that the patellar implant is embedded on the patellar bone.The patellar implant is placed on top of a flat tibial osteotomy or cut-surfaced bone
15899913|NCT03650426|Procedure|Total knee with inlay patellar resurfacing technique|The patellar resurfacing technique that the patellar implant is embedded in the patellar bone.The patellar implant is surrounded by a rim of cortical bone and supported by hardened, sclerotic bone
15899914|NCT03650413|Drug|UTTR1147A|UTTR1147A will be administered based on disease status, as described in the protocol.
15899915|NCT03650400|Drug|Fevipiprant|Chewable tablet
15899916|NCT03650387|Device|RADIESSE® (+) Lidocaine|RADIESSE® (+) Lidocaine will be injected as per its current approved labelling and investigator's usual practice
15899917|NCT03650374|Other|Standard of Care Rehabilitation|Knee flexion and extension strength training exercises for the contralateral (non-operative) lower extremity in addition to standard of care postoperative rehabilitation.
15899918|NCT03650374|Other|Experimental Strength Training|Will be performed with moderate resistance and will require moderate effort. Exercises will include unilateral leg presses, lunges, step ups, and step downs. These exercises are performed as standard of care but are not typically introduced into the physical therapy regimen until 10-12 weeks postoperatively. In the experimental group, these exercises will be introduced starting with the first postoperative physical therapy session, but only for the contralateral (non-operative) leg.
15899919|NCT03650361|Drug|Adapalene Gel 0.3%|Treatment applied as a thin layer of the product to the entire face once a day in the evening for 84 days
15899920|NCT03650361|Drug|Differin 0.3% Topical Gel|Treatment applied as a thin layer of the product to the entire face once a day in the evening for 84 days
15899921|NCT03650361|Drug|Adapalene Gel 0.3% Vehicle Placebo|Treatment applied as a thin layer of the product to the entire face once a day in the evening for 84 days
15899922|NCT03650348|Drug|PRS-343 in Combination with Atezolizumab|HER2/4-1BB Bispecific
15899923|NCT03650322|Behavioral|Yoga|12 weeks, total of 150 minutes of exercise per week.
15899924|NCT03650322|Behavioral|Stretching and Toning|12 weeks, total of 150 minutes of exercise per week.
15899925|NCT03650322|Behavioral|Aerobic Walking|12 weeks, total of 150 minutes of exercise per week.
15899926|NCT03650309|Device|Deep Brain Stimulation|All patients will undergo surgical implantation of a deep brain stimulation (DBS) system, which involves placement of stimulating electrodes in the brain. These electrodes will be used to deliver electrical current to target two brain structures involved in the pathophysiology of obesity.
15899927|NCT03650296|Device|ePER vs PS vs PaedER|see detailed description of methods
15899928|NCT03650283|Other|monitoring|The bispectral index (BIS) and skin conductance (SC) monitors will be connected when patient will be positioned on the operating table. A BIS value greater than 60 will be considered an indicator of light anaesthesia. The SC monitoring will be achieved using the MEDSTORM AS 2005 monitor. Number of fluctuations in mean skin conductance (NFSC) of >0.1 s-1 in a period of 15 s might be counted as a significant change and indicates an increase in the sympathetic outflow. General anaesthesia will be performed and laryngeal mask will be inserted. Blood pressure, heart rate, BIS, SC, and PRST (pressure, rate, sweating, tears) score will be recorded.
15899929|NCT03650270|Drug|Phenobarbital|Three repeated doses of pareneteral phenobarbital was compared to a single parenteral infusion of phenytoin followed by an infusion of parenteral midazolam
15899930|NCT03650257|Biological|gp96|25 mcg IH
15899931|NCT03650257|Drug|Temozolomide|temozolomide monotherapy (150-200 mg / m2 / day for 5 days, then discontinuance for 23 days , 28 days for a a cycle, a total of 6 cycles ).
15899932|NCT03650257|Radiation|radiotherapy|Stupp regimen of radiotherapy
15899933|NCT03650244|Device|REMEEX implantation|Device implantation
15899934|NCT03650231|Other|Serological giagnosis|The serological diagnosis of EBV infection was performed in the Amiens University Hospital virology laboratory (France). 91 routinely collected samples were analyzed by Immulite, Architect, and Liaison Blood samples were centrifuged for 15 min at 2500g at room temperature. Sera were aliquoted and first analyzed by Immulite. All samples were tested for EBV VCA IgG, EBV VCA IgM and EBV EBNA IgG in order to determine infection status (primary EBV infection, past infection, absence of infection and indeterminate status).
15899935|NCT03650218|Device|THIODERM STRONG|Soft tissue filler containing crosslinked hyaluronic acid and Na-hyaluronate, supplemented with lidocaine hydrochloride as ancillary substance.
15899936|NCT03650205|Drug|Ivabradine|Ivabradine capsule
15899937|NCT03650205|Drug|Placebo|Placebo oral capsule.
15899938|NCT03650192|Device|INVSENSOR00027|Investigational, noninvasive sensor that will be placed on the subject's chest and/or back. INVSENSOR00027 measures signals regarding subject's movement and posture, heart rate, and respiratory rate.
15899939|NCT03650179|Other|Observational study : No intervention|Observational study : No intervention. Only exporting data
15899940|NCT03650166|Other|MyBP|This program includes online video high BP education and longitudinal, personalized assistance of home BP self-monitoring.
15899943|NCT03650153|Procedure|Trans-perineal MRI targeted Biopsy|Trans-perineal biopsy of the prostate: The sample is removed with a thin needle that is inserted through the skin of the perineum and into the prostate.
15899944|NCT03650140|Dietary Supplement|Tart cherry extract 60 mL|Subjects will receive a single 60 mL oral dose of tart cherry extract.
15899945|NCT03650140|Dietary Supplement|Tart cherry extract 120 mL|Subjects will receive a single 120 mL oral dose of tart cherry extract.
15899946|NCT03650114|Biological|Ofatumumab|subcutaneous injection of 20 mg ofatumumab every 4 weeks
15899947|NCT03650114|Biological|Tetanus toxoid (TT) containing vaccine (Td, Tdap)|0.5mL Vial/Syringe Containing 5 limit of flocculation (LF) tetanus toxoid
15899948|NCT03650114|Biological|13-valent pneumococcal conjugate vaccine (13-PCV)|0.5mL Vial/Syringe
15899949|NCT03650114|Biological|23-valent pneumococcal polysaccharide vaccine (23-PPV)|0.5mL Vial/Syringe
15899950|NCT03650114|Biological|Seasonal Quadrivalent influenza vaccine|Seasonal 2020-2021 0.5mL Vial/Syringe (trivalent may be used where quadrivalent is not available)
15899951|NCT03650114|Biological|Keyhole limpet hemocyanin (KLH) neo-antigen|1mg Vial
15899952|NCT03650101|Procedure|ETV/CPC|The Endoscopic Third Ventriculostomy/Choroid Plexus Cauterization (ETV/CPC) will comprise a standard frontal approach with flexible endoscopy.
15899953|NCT03650088|Behavioral|Behavioral weight loss with digital tools|Participants will monitor their diet in a study smart phone app using a 'traffic light' approach where foods are categorized as red (high fat and/or calorie), yellow (moderate fat/calorie, high nutrient), or green (low fat/calorie, high nutrient) and adhere to a red food limit recommendation, weigh daily on a digital scale whose data syncs to the study app, gradually increase physical activity and track it using a wearable device for which data is also synced to the app, and monitor blood glucose using Continuous Glucose Monitoring. Participants will meet weekly with a trained interventionist for behavioral lessons (adapted from Diabetes Prevention Program curriculum) and counseling.
15899954|NCT03650075|Drug|MG-S-2525|The investigational product is MG-S-2525, which is an oral, small-molecule, anti-inflammatory agent. MG-S-2525 is being developed by Metagone Biotech Inc. and contains the new molecular entity HL0, an inhibitor of MAP3K19 which is up-regulated in disease pathobiology and in response to inflammatory stimuli in IPF.
15899955|NCT03650036|Drug|Pulp Therapy CTZ Paste|CTZ paste is composed of 62.5 mg of chloramphenicol, 62.5 mg of tetracycline and 125 mg of zinc oxide and manipulated with 0.1ml of eugenol in a sterile glass plate with flexible metal spatula at the time of use.
15899956|NCT03650036|Drug|Pulp Therapy ZOE Paste|The zinc oxide of the ZOE paste will be supplied in 250mg capsules and handled with 0.1ml eugenol in a sterile glass plate with metal spatula at the time of use.
15899957|NCT03650023|Dietary Supplement|Chitosan Oligosaccharide (GO2KA1)|Chitosan Oligosaccharide (GO2KA1) capsule was consumed within 15 min, and then 2-h oral sucrose tolerance test was conducted.
15899958|NCT03650023|Dietary Supplement|White egg|White egg capsule was consumed within 15 min, and then 2-h oral sucrose tolerance test was conducted.
15899959|NCT03650010|Procedure|Total ankle replacement|total ankle prosthesis through a lateral or an anterior approach
15899960|NCT03649997|Drug|JNJ-61393215|Participants will be administered JNJ-61393215 in Part 1, 2 and 3 of study as oral suspension.
15899961|NCT03649997|Drug|Placebo|Participants will be administered JNJ-61393215-matching placebo in Part 1, 2 and 3 of study as oral suspension.
15899962|NCT03649997|Drug|JNJ-61393215|Participants will be administered JNJ-61393215 in Part 1, 2 and 3 of study as capsule.
15899963|NCT03649984|Behavioral|Symptom Navi© Program|Trained nurses provide two semi-structured patient education consultations with Symptom Navi© Flyers. Patients will use the Symptom Navi© Flyers individually at home.
15899964|NCT03649971|Drug|Guselkumab|Guselkumab SC will be administered every 4 weeks.
15899965|NCT03649971|Drug|Placebo|Placebo SC will be administered every 4 weeks.
15899966|NCT03649958|Device|HIRREM-SOP|HIRREM-SOP for ten 90 minute sessions
15899967|NCT03649945|Drug|Docetaxel|75mg/m2，3 weeks for one cycle，dosed on the first day of every cycle,totally 6 cycles
15899968|NCT03649945|Drug|Nedaplatin|80 mg/m2,3 weeks for one cycle，dosed on the first day of every cycle,totally 6 cycles
15899969|NCT03649945|Drug|Endostar|7.5mg/m2，once a day, continuously dosed for 14 days, then stop for 7 days,3 weeks for one cycle, totally 6 cycles
15899971|NCT03649906|Procedure|Optimized Localization Technique|The small pulmonary nodules of the subjects will be located using an optimized pre-loaded microcoil puncture locating method.
15899972|NCT03649893|Device|Active Office|Active Office intervention includes sit-to-stand desk, bike desk, seddle chair, and active breaks.
15899973|NCT03649880|Drug|¹⁸F-Fluoromisonidazole|Given IV
15899974|NCT03649880|Procedure|Computed Tomography|Undergo PET/CT
15899975|NCT03649880|Procedure|Magnetic Resonance Imaging|Undergo PET/MRI
15899976|NCT03649880|Procedure|Positron Emission Tomography|Undergo PET/MRI
15899977|NCT03649867|Other|Semi-structured interviews|Each participant will attend a 30-45 minute semi-structured interview conducted by the CI
15899978|NCT03649841|Drug|Antiandrogen Therapy|Undergo ADT
15899979|NCT03649841|Drug|Abiraterone Acetate|Undergo Abiraterone Acetate Treatment SOC
15899980|NCT03649841|Drug|Prednisone|Undergo Prednisone Treatment SOC
15899981|NCT03649841|Radiation|Radiation Therapy|Undergo neutron radiation therapy
15900047|NCT03649308|Procedure|Conventional treatment|Traditional treatment with conventional wound dressing and 5 days of immobilization after surgery.
15919899|NCT03498677|Behavioral|presentation order|section presentation one
15899982|NCT03649828|Dietary Supplement|probiotic milk fermented with kefir grains|Participants received probiotic milk fermented with kefir grains for consumption for 11 weeks. Before and after treatment, blood samples were collected for biochemical analysis and anthropometric data were also evaluated.
15899983|NCT03649828|Dietary Supplement|curd|Participants received the curd for consumption for 11 weeks. Before and after treatment, blood samples were collected for biochemical analysis and anthropometric data were also evaluated.
15899984|NCT03649815|Combination Product|App4Independence|"The mobile, app-based platform was designed to:
~Help prevent social isolation through personalized prompts, scheduling of activities, and connections to a range of resources relevant to social engagement
~Enhance hopeful and informed engagement in the recovery process through functions that foster resilience and draw on evidence based strategies to enhance wellness (e.g., personalized affirmations; tip sheets; relaxation exercises)
~Encourage and check-in on daily essential activities for patients - addressing memory, attention, and initiation challenges that often occur as a part of this illness
~Provide basic health/safety functionality and track level of wellness
~Provide an anonymous peer-peer online network for strategy sharing
~Provide an ambient sound detector to assist with identifying hallucinations"
15899985|NCT03649802|Dietary Supplement|Low dose vitamin D3|Low dose arm-800 IU given daily
15899986|NCT03649802|Dietary Supplement|High dose vitamin D3|High dose arm-5000 IU given daily
15899987|NCT03649776|Other|Mental Health First Aid|Mental Health First Aid (MHFA) is listed in the Substance Abuse and Mental Health Services Administration's National Registry of Evidence-based Programs and Practices. The program also teaches the common risk factors and warning signs of specific types of illnesses like anxiety, depression, substance use, bipolar disorder, eating disorders, and schizophrenia. Participants are introduced to local mental health resources, national organizations, support groups, and online tools for mental health and addictions treatment and support.
15899988|NCT03649763|Drug|Lidocaine|lidocaine 1%, distal ( ulnar and medial nerve): 6ml/nerve , 12m total
15899989|NCT03649763|Drug|Bupivacaine|Bupivacaine 0.5%,distal ( ulnar and medial nerve): 6ml/nerve , 12m total
15899990|NCT03649763|Drug|Lidocaine|lidocaine 1%, distal and proximal ( ulnar and medial nerve): 3ml/nerve , 12m total
15899991|NCT03649750|Drug|Mucinex®|Mucinex® 600 mg ER bi-layer tablets
15899992|NCT03649737|Behavioral|Exercise Intervention|Attend supervised and unsupervised exercise sessions
15899993|NCT03649737|Other|Survey Administration|Ancillary studies
15899994|NCT03649737|Other|Quality-of-Life Assessment|Ancillary studies
15899995|NCT03649724|Drug|Placebo|Placebo (0.25 ml normal saline) will be administered subcutaneously once every twelve weeks for 48 weeks.
15899996|NCT03649724|Drug|Eligard 22.5Mg Suspension for Injection|Eligard 22.5Mg Suspension for Injection will be administered subcutaneously, in accord with manufacturer's direction, once every twelve weeks for 48 weeks.
15899997|NCT03649711|Drug|Ticagrelor 90mg|Ticagrelor Pill
15899998|NCT03649711|Drug|Clopidogrel 75mg|Clopidogrel Pill and a matching placebo to conceal frequency
15899999|NCT03649711|Drug|Aspirin 81 mg|Aspirin Pill
15900000|NCT03649698|Behavioral|Home-based training program|Exercise intervention: During the intervention period, the participant will perform the optimized and personally adapted Otago Exercise Program (OEP). The participant is encouraged to perform the resistance exercises three times a week with a rest day in between. The participant is advised to perform the exercises in close temporal proximity to one of the moments of the intake of the protein supplement. The participant will also follow a walking plan in which he or she needs to walk 30 minutes twice a week. These 30 minutes can be broken down to three 10-minute walks throughout the day. During the follow-up period, participants may continue the OEP, but no personal encouragement will be given during this period.
15900001|NCT03649698|Dietary Supplement|High-quality protein supplement|The participant will receive an individually adapted protein supplement to achieve the recommend total (usual diet and supplements) daily intake of 1.5 g/protein/kg for frail elderly. This will be realized by adding an individualized amount (g) of protein powder during breakfast, lunch, dinner or snack between meals, or before breakfast or after dinner, based on the subjects' food intake assessed by a food diary. The participant will take the protein supplement from 5 days before the start of the intervention. The protein powder is commercially available and consists of 4.5g protein/5g powder. During the follow-up, no protein supplement is added.
15900002|NCT03649698|Dietary Supplement|Omega-3 fatty acid|Four weeks before the start of the intervention, the participant will start the intake of 1 omega-3 capsule providing in total 500 mg EPA and 450 mg DHA until the end of the intervention. He or she has to take the supplement once daily at a chosen time. During the follow-up, no omega-3 supplement will be given.
15900003|NCT03649698|Drug|Placebo protein powder|Isocaloric maltodextrin powder. Amount based on food diary.
15900004|NCT03649698|Drug|Placebo omega-3|Peanut oil soft gel capsules. 1g/ capsule. 1 capsule/day
15900005|NCT03649685|Device|Continuous theta burst stimulation (cTBS)|50Hz of 90% MT for 3 pulses train over will be repeated at 200ms for the 40s, 600 pulses
15900006|NCT03649685|Device|shame rTMS|The sham coil has been specifically developed to mimic the real one but is not associated with a stimulus sensation compared to the coil delivering real stimulation cTBS.
15900007|NCT03649672|Device|TOF Watch SX|Neuromuscular monitoring via the TOF Watch SX device
15900008|NCT03649659|Drug|Silver Diamine Fluoride|SDF will be applied twice during the study
15900009|NCT03649659|Drug|Placebo|This is being compared to the SDF and will also be applied twice
15900010|NCT03649633|Drug|Stress-dose Hydrocortisone plus Vitamin C|Treatment of septic shock with vitamin C and stress-dose hydrocortisone aimed at the attenuation of the systemic inflammatory response and the improvement of vasopressor responsiveness.
15900011|NCT03649633|Drug|isotonic sodium chloride solution placebo plus isotonic sodium chloride solution placebo|Treatment of septic shock with placebo (corresponding to Vitamin C) and placebo (corresponding to hydrocortisone).
15900012|NCT03649620|Dietary Supplement|unripe Bokbunja Extract|tablet(1 tablet/d, 600 mg/d) for 12 weeks
15900013|NCT03649620|Dietary Supplement|Placebo|Placebo for 12 weeks
15900073|NCT03649100|Procedure|Implant placement|Conventional implant placement. Implant site development was prepared according to the manufacturer's instruction by the investigator, before knowing the randomized implant (NH or SA).
15900074|NCT03649087|Other|Vitrification|Vitrification of ovarian tissue
15900014|NCT03649607|Other|Accelerated Resolution Therapy|ART was developed to treat both physiological and cognitive aspects of PTSD, which has been described as a consequence of failed memory processing. The use of Voluntary Image Replacement (VIR) parallels imaging re-scripting in which a preexisting negative mental image is transformed into a more benign image. This has been successfully used to treat survivors of traumatic industrial accidents suffering from PTSD. Participants will complete five sessions over a 21-day period.
15900015|NCT03649581|Other|compare the two groups of schizophrenic patients|"Compare two groups of markers relating respectively to psychomotricity and affectivity in two subforms of schizophrenia: periodic catatonia and hebephrenia in order to highlight a possible double dissociation:
~abnormalities of markers related to affectivity in Hebephrenia (with preservation of these markers in periodic catatonia),
~abnormalities of markers related to psychomotricity in periodic catatonia (with markers of these tests in Hebephrenia)."
15900016|NCT03649581|Other|compare the two groups of schizophrenic patients versus volunteers|compare the results of the schizophrenic patient group with healthy volunteers
15900017|NCT03649568|Other|Pork|1 oz lean pork
15900018|NCT03649568|Other|Egg|1 large whole egg
15900019|NCT03649568|Other|Black beans|0.5 cups cooked black beans
15900020|NCT03649568|Other|Almonds|1 oz almonds
15900021|NCT03649555|Drug|[18F]-FTC-146|Two 5 mCi [18F]-FTC-146 doses will be administered intravenously on two separate scan days at least one week apart (total per study = 10 mCi) Participants who complete both test days will receive 10 mCi total dose; however, if a participant is unable to return for a second test day due to unforeseen circumstances, they will receive 5 mCi total dose.
15900022|NCT03649542|Other|Fluidotherapy plus exercise|The Fluidotherapy® unit (ULTRA 115: Henley International, Sugar Land, Texas) is a high intensity heat modality consisting of a dry whirlpool of finely divided solid particles suspended in a heated air stream. A certified technician The cleaned the Fluidotherapy® unit per the user manual.
15900023|NCT03649529|Biological|GPA-TriMAR-T|Patients will undergo leukapheresis to isolate autologous T cells, these T cells will be activated and modified to express GPA-TriMAR in the manufacture facility, and eventually infused back into the body for treatment.
15900024|NCT03649516|Device|iCKD APP|Use iCKD APP to upload home bio-information data
15900025|NCT03649503|Other|No intervention|
15900026|NCT03649477|Drug|3.2 mg intranasal carbetocin|three times per day with meals
15900027|NCT03649477|Drug|9.6 mg intranasal carbetocin|three times per day with meals
15900028|NCT03649477|Drug|placebo|three times per day with meals
15900029|NCT03649464|Drug|OKN-007|"Dose escalation/PK cohort (Phase Ib): 1000mg twice daily (BID), 1000mg thrice daily (TID), 1500mg thrice daily (TID).
~Expansion cohort (Phase 2): MTD defined in the dose escalation (Phase Ib) study."
15900030|NCT03649438|Drug|131 I-Metaiodobenzylguanidine|"Minimum dose of 10 mCi/kg for patients without a stem cell source whose renal function is above the upper limit of normal but still meets eligibility criteria.
~Dose of 12 mCi/kg for patients without a stem cell source with normal renal function and meets other eligibility criteria.
~Dose of > 12 mCi/kg to 18 mCi/kg maximum at investigator's discretion for patients meeting eligibility criteria with stem cells available."
15900031|NCT03649438|Drug|Potassium Iodide|For the therapeutic MIBG administration, potassium iodide solution will be administered in a loading dose of 6mg/kg orally at least 8 hours prior to the MIBG injection, and then will be given at 1mg/kg/dose every 4 hours on days 0-6, then 1 mg/kg/day through day 45 post injection.
15900032|NCT03649438|Drug|G-csf|It is recommended that patients with ANC less than 750 after MIBG infusion begin G-CSF 5 mcg/kg/day subcutaneously (or receive equivalent single dose of Neulasta every 14 days while neutropenic) until neutrophil recovery (generally >5000). This will start 24 hours after stem cell infusion (if stem cells are to be infused).
15900033|NCT03649412|Drug|GSK2982772 Modified Release|GSK2982772 MR will be available as MR prototype coated tablet with unit dose strength of 240 mg in Part A. In Part B, GSK2982772 MR prototype coated tablet with unit dose strength of 120 mg (may be changed following interim review of Part B) will be administered by subjects. GSK2982772 MR will be administered orally with 240 milliliter (mL) of water.
15900034|NCT03649412|Drug|GSK2982772 Immediate Release|In part A, GSK2982772 IR tablet will be available with unit dose strength of 30 mg and the total dose administered by subjects will be 240 mg (8 tablets of dose strength 30 mg) orally with 240 mL of water
15900035|NCT03649399|Diagnostic Test|Abdominal ultrasound|Abdominal ultrasound for detection of the pancreatic stent
15900036|NCT03649386|Device|Heated and humidified breathing circuit on|Heated and humidified breathing circuit will be turned on.
15900037|NCT03649386|Device|Heated and humidified breathing circuit off|Heated and humidified breathing circuit will be turned off.
15900038|NCT03649373|Procedure|Noergaard technique|The patient is placed standing in an upright position in front of the rail on a hospital bed. Legs should be stretched with a wide well balanced stance. The patient is then instructed to bend forwards, resting the forehead on the back of the non-affected forearm, which is put on the rail. The affected arm should now be relaxed and stretched, hanging straight down toward the floor. The patient is then instructed to attempt to relax and make pendular and circular motions with the affected arm hanging down. Successful reduction occurs when sufficient muscle relaxation allows the humeral head to reposition to its natural position in the glenoid fossa. Often the patient will experience a popping sensation when the shoulder is reduced.
15900039|NCT03649347|Behavioral|Augmented reality exposure therapy|Exposure therapy via utilization of augmented reality. Virtual objects will be placed on the patient's real environment for exposure therapy.
15900040|NCT03649334|Drug|ketamine-ketorolac|The patient will receive ketamine 0.5mg.kg-1 + ketorolac 1mk.kg-1 in 2 ml syringe intramuscularly.
15900041|NCT03649334|Drug|fentanyl- ketorolac|The patient will receive fentanyl 1.5ug.kg-1 + ketorolac 1 mg.kg-1 in 2ml syringe intramuscularly
15900046|NCT03649308|Device|Negative Pressure Wound Therapy|An immediate mobilization and negative pressure wound therapy (PICO) initiated after surgery.
15902072|NCT03633591|Drug|Tolcapone|Multiple doses of tolcapone tablets in the fasted state
15900048|NCT03649295|Other|Functional Electrical Stimulation|"Functional electrical stimulation device obeying the following steps:
~Muscle heating - 2 min, 10 Hz, 250 μm; Potentiation of muscle fibers type I - 8 min, 30 Hz, 250 μm; Potentiation of muscle fibers type II - 8 min, 80 Hz, 300 μm; Toning - 8 min, 30 Hz, 300 μm; Muscle Relaxation - 4 min, 5 Hz, 200 μm One channel of electrodes will be placed in the submental region and the other in the thyroid. Treatment should be started at minimum levels of intensity, increasing carefully until appropriate effects are achieved in the procedure"
15900049|NCT03649295|Other|Conventional Speech Therapy|Conventional speech therapy with laryngeal elevation exercises, stimulation of oral reflexes such as swallowing reflex, tongue movements, lips and cheeks, gustatory therapy
15900050|NCT03649282|Other|HFNC|HFNC therapy will be delivered with a system that provides heated, humidified high flow of gas through a tube that maintains the temperature and humidification. This intervention will involve the delivery of gas (air/oxygen) at a high flow rate, using an adequate nasal cannulae size and a cannula/nostril diameter ratio between 0.5-0.8.
15900051|NCT03649282|Other|NCPAP|NCPAP will be provided as either bubble CPAP or through a ventilator, and will deliver a regulated pressure of gas (air/oxygen) to the patient through infant binasal prongs as interface. Nasal prong sizes will be chosen according to manufacturer recommendations.
15900052|NCT03649269|Dietary Supplement|PC-300 tea.|Patients had to drink one cup of the tea half an hour before breakfast, main meal and dinner.
15900053|NCT03649269|Drug|Bezafibrate|Patients were prescribed 200 mg/day at night.
15900054|NCT03649256|Diagnostic Test|Thickness of lower uterine segment scar|Ultrasound measurement of thickness of the uterine scar at 3 and 6 months
15900055|NCT03649243|Drug|Propolis spray|Propolis was added at the site of injury, 3 puff for any wound in the foot of patients. All the patients decide voluntary if they want to receive the propolis spray treatment or only receive they normal wound healing care.
15900056|NCT03649230|Drug|300mg netupitant/0.5mg palonosetron hydrochloride|Antiemetic (NK1 receptor antagonist/5-HT3 receptor antagonist)
15900057|NCT03649217|Device|wearing the iStride device|The device mimics the actions of the split-belt treadmill, but can be used during over-ground walking and in one's own home, thus enabling long-term training. This device does not require any external power and is completely passive; all necessary forces are redirected from the natural forces present during walking since it utilizes the wearer's weight to generate its movements. This research aims to test the iStride on individuals with stroke in their own home in order to determine if the related effects that we saw in the clinic, can also benefit patients at home.
15900058|NCT03649204|Behavioral|HY-PAD|Hybrid intervention that includes supervised on-site and home-based components in people with PAD
15900059|NCT03649191|Other|The BABEL Approach to Advance Care Planning in Nursing Homes|In intervention nursing homes, eligible residents will: (i) receive The BABEL Approach to Advance Care Planning (ACP), (ii) after these ACP discussions occur, the resident's primary care physician will be notified of the residents' ACP wishes, (iii) a brightly colored document will be placed in a standard location of the NH chart that identifies the resident's ACP wishes, (iv) paramedics will be educated to know about these sheets and where to find them, and that they should be taken with any resident transferred to another care setting.
15900060|NCT03649191|Other|Control group Advance Care Planning|Eligible residents in each control nursing homes will receive the prevalent approach to Advance Care Planning in that nursing home. No elements of The BABEL Approach to Advance Care Planning will be introduced in the control homes.
15900061|NCT03649178|Other|salt|Participants will randomly eat a high salt diet for 8 weeks and a low salt diet for 8 weeks
15900062|NCT03649165|Drug|Treatment A|During Part 1 of the study, participants will receive single doses of selumetinib 25 mg granule under fasted conditions. The dose will be administered after an overnight fast of at least 10 hours. The IMP will be administered with approximately 240 mL of water. No food will be allowed for at least 4 hours post-dose.
15900063|NCT03649165|Drug|Treatment B|During Part 1 of the study, participants will receive single doses of selumetinib 50 mg capsule under fasted conditions. The dose will be administered after an overnight fast of at least 10 hours. The IMP will be administered with approximately 240 mL of water. No food will be allowed for at least 4 hours post-dose.
15900064|NCT03649165|Drug|Treatment C|During Part 2 of the study, participants will receive single doses of selumetinib 25 mg granule under fed conditions. Following an overnight fast of at least 10 hours, participants will start consumption of the recommended meal within 30 minutes before administration of the IMP. Participants will be required to consume the entire meal in 30 minutes or less; however, the IMP should be administered 30 minutes after start of the meal. The IMP will be administered with approximately 240 mL of water. No food will be allowed for at least 4 hours post-dose, where after a meal may be provided.
15900065|NCT03649165|Drug|Treatment D|During Part 2 of the study, participants will receive single doses of selumetinib 50 mg capsule under fed conditions. Following an overnight fast of at least 10 hours, participants will start consumption of the recommended meal within 30 minutes before administration of the IMP. Participants will be required to consume the entire meal in 30 minutes or less; however, the IMP should be administered 30 minutes after start of the meal. The IMP will be administered with approximately 240 mL of water. No food will be allowed for at least 4 hours post-dose, where after a meal may be provided.
15900066|NCT03649165|Drug|Acetaminophen|Participants will receive a single 500mg dose of acetaminophen at the same time.
15900067|NCT03649152|Drug|Propagermanium|Immediate release capsule
15900068|NCT03649152|Drug|Placebo|Placebo capsule
15900069|NCT03649139|Drug|sublingual immunotherapy drops|artemisia annua (sweet sagewort) allergen extract drops
15900070|NCT03649139|Drug|Placebo drops|sublingual placebo drops
15900071|NCT03649126|Behavioral|Implementation tools|Implementation tools developed by experts in order to increase the use of SSR in pathology
15900072|NCT03649113|Procedure|sclerotherapy arm|The liver mass will be punctured under guidance of ultrasonography with a 20- or 22-gauge Chiba needle. Contrast medium will be injected under fluoroscopy guidance to assess any possible communication with the biliary tree and to evaluate the amount of sclerosing agent which could be safely injected. Then, the mixture of Bleomycin (Bleocin-S; Korea United Pharm Inc., South Korea) and Lipiodol (Ultra-Fluid, Guerbet, France) will be slowly injected under continuous guidance of fluoroscopy. No more than 45 units of Bleomycin and 15 cc of Lipiodol will be injected in a single session.
15900180|NCT03648229|Drug|Timolol ophthalmic solution|Timolol ophthalmic solution 0.5% for reduction of intraocular pressure
15900075|NCT03649074|Device|AKL-T01|"AKL-T01 multitasking digital treatment. AKL-T01 multitasking treatment employs perceptual discrimination attention/memory task as well as a continuous motor driving task."
15900076|NCT03649061|Drug|Etanercept 50 MG/ML|Etanercept 50mg subcutaneous (SC) weekly added for 24 weeks to COBRA-Slim scheme
15900077|NCT03649061|Drug|Leflunomide 10 milligram (MG)|Leflunomide 10mg PO daily added to the COBRA-Slim scheme
15900078|NCT03649048|Drug|High-Dose Cisplatin|Intravenous administration of High-Dose Cisplatin
15900079|NCT03649048|Drug|Low-Dose Cisplatin|Intravenous administration of Low-Dose Cisplatin
15900080|NCT03649048|Radiation|Radiotherapy|Participating centres are to follow their local radiation treatment planning and delivery techniques.
15900081|NCT03649035|Device|HTP treatment|Elegible patients will undergo HTP treatment, followed by standard of care Chemo therapy and SBRT protocol.
15900082|NCT03649022|Device|Catheter ablation|Ventricular Tachycardia ablation, that will be performed per clinical practice, by using EnSite Precision mapping system with the Flexability catheter (St.Jude, now Abbott)
15900083|NCT03649009|Other|Normal Saline|Normal Saline 50 mls infused over 1 hour 3 times per day for total 3 days after recruitment and randomization.
15900084|NCT03649009|Drug|Thiamine|IV Thiamine 200 mg diluted in 50 mls normal saline infused over 1 hour 3 times per day for total 3 days after recruitment and randomization
15900085|NCT03649009|Drug|Hydrocortisone|If patient develop redness or rashes after normal saline infusion, IV hydrocortisone 200 mg stat will be given
15900086|NCT03649009|Other|Metoclopramide|If patient develop nausea after IV thiamine infusion, IV metoclopramide 10mg stat will be given. If patient develop redness or rashes after normal saline infusion, IV hydrocortisone 200 mg stat will be given.
15900087|NCT03648996|Other|Low-fructose diet, isocaloric|6 month of consumption a low fructose diet
15900088|NCT03648996|Drug|Allopurinol|6 months of allopurinol treatment with the goal of decreasing uric acid compared to control group
15900089|NCT03648996|Drug|Placebo|6 months of placebo treatment
15900090|NCT03648996|Other|Low-fructose, hypocaloric|6 month of consumption a low fructose diet with a 500 Calorie/day energy restriction
15900091|NCT03648983|Procedure|arm circumference measurement|Undergo arm circumference measurement
15900092|NCT03648983|Device|Bioimpedance spectroscopy|bioimpedance spectroscopy
15900093|NCT03648970|Drug|Pravastatin|The participant will be given pravastatin 2 x 20 mg per oral daily
15900094|NCT03648957|Behavioral|Lifestyle counselling|First behavioral counselling session will be conducted before discharge and follow-up session will be offered with 3-4 weeks intervals either by telephone or in the outpatient clinic.
15900095|NCT03648957|Behavioral|Usual care|Usual stroke care discharge session; including written and verbal encouragement to a healthy lifestyle.
15900096|NCT03648957|Device|Activity tracker|Participants are encouraged to wear a activity tracker to monitor their physical activity
15900097|NCT03648944|Other|Accelerated Rehabillitation|
15900098|NCT03648944|Other|Non-Accelerated Rehabillitation|
15900099|NCT03648931|Behavioral|Focus Group Discussion (FGD)|"No actual intervention is planned. A single focus group discussion (FGD) with community members in the same group assignment will be conducted to assess study outcome measures. In particular, the FGDs will focus on:
~Perceptions of taboos and acceptable and/or typical practices during pregnancy, childbirth and breastfeeding
~Perceptions of HIV risk during pregnancy and breastfeeding
~Perceived role of male partners during pregnancy and breastfeeding
~Main challenge(s) perceived with VR and oral PrEP use during pregnancy and breastfeeding
~Main factor(s) perceived to facilitate VR and oral PrEP use during pregnancy and breastfeeding
~Willingness to join a VR and/or oral PrEP study during pregnancy and breastfeeding"
15900100|NCT03648931|Behavioral|In-depth Interview (IDI)|"No actual intervention is planned. A single in-depth interview (IDI) will be conducted to assess study outcome measures, focusing on the following topics:
~Perceptions of taboos and acceptable and/or typical practices during pregnancy, childbirth and breastfeeding
~Perceptions of HIV risk during pregnancy and breastfeeding
~Perceived role of male partners during pregnancy and breastfeeding
~Main challenge(s) perceived with VR and oral PrEP use during pregnancy and breastfeeding
~Main factor(s) perceived to facilitate VR and oral PrEP use during pregnancy and breastfeeding
~How others in their professional and social networks and communities would view the VR and/or oral PrEP use by pregnant and breastfeeding women"
15900101|NCT03648918|Other|Blood Collection|Blood will be collected via venipuncture and analyzed. Blood samples will be analyzed for HLA haplotype (a genetic sequence related to type 1 diabetes susceptibility), plasma-induced signature, diabetes autoantibodies, complete blood count with differential, and serum and plasma for storage. For family members with diabetes, blood will also be tested for A1c.
15900102|NCT03648905|Drug|18F-Dopa|18F-DOPA is a positron-emitting analog of the catechol amino acid, levodopa (L-DOPA, Ldihydroxyphenylalanine). 18F-DOPA PET scanning is used to visualize catecholamine terminals in the brain.
15900103|NCT03648905|Drug|11C-methylreboxetine|11C-MRB may be injected IV for visualizing sites of neuronal uptake of norepinephrine in the brain or periphery by PET scanning.
15900104|NCT03648905|Drug|13N-Ammonia|13N-labeled ammonia is a perfusion imaging agent used to obtain perfusion-corrected values for 18F-dopamine-derived radioactivity in the heart and other organs.
15900105|NCT03648905|Drug|18F-Dopamne|18F-Dopamine is a positron-emitting analog of the catecholamine, dopamine. 18F- Dopamine positron emission tomographic (PET) scanning may be used to visualize sympathetic innervation.
15900106|NCT03648905|Drug|Desipramine (DMI)|Desipramine (DMI) is an approved tricyclic antidepressant. The drug inhibits neuronal uptake of catecholamines. DMI treatment is used to test for effects of NET inhibition on results of 11C-MRB or 18F-dopamine PET scans. The subject receives a single dose of DMI by mouth (about 125 mg per 70 kg body mass) about 2-3 hours before the subject receives the PET imaging agent.
15900107|NCT03648892|Drug|[c11] raclopride|The present study will attempt to resolve the controversy by measuring D2BP using both [18F]fallypride and [11C]raclopride in 39 adults, 13 within each of three BMI strata to represent a large BMI range, under controlled overnight fasting conditions following a period of dietary stabilization. The primary aims are to estimate the mathematical relationship between striatal D2BP and BMI and determine the within-subject correlations of D2BP derived from [18F]fallypride and [11C]raclopride.
15900329|NCT03647150|Behavioral|Mother Care group|Nutrition education via mother care groups lead by a respected elder in the local community
15900108|NCT03648892|Drug|[18F]fallypride|The present study will attempt to resolve the controversy by measuring D2BP using both [18F]fallypride and [11C]raclopride in 39 adults, 13 within each of three BMI strata to represent a large BMI range, under controlled overnight fasting conditions following a period of dietary stabilization. The primary aims are to estimate the mathematical relationship between striatal D2BP and BMI and determine the within-subject correlations of D2BP derived from [18F]fallypride and [11C]raclopride.
15900109|NCT03648879|Device|Endoscope+Cellvizio(R) 100 microscope|Patients will undergo white-light, upper endoscopy. In addition, during this endoscopy patients will undergo Confocal Endoscopic Microscopy (CEM) using the Cellvizio probe (Mauna Kea Technologies) to scan the same anatomic zones.
15900110|NCT03648866|Other|interview|"Initial interview and potential follow-up interviews and focus group with Florida Hospital employees.
~Interview participants in compassion rounds"
15900111|NCT03648853|Device|Tetanic Stimulus|5 second 100 Hz 70 mA tetanic stimulus will be applied to three different locations in a random order
15900112|NCT03648840|Behavioral|Aversive cue|Participants will be exposed to unpleasant pictures and tones during performance of a task to earn alcohol
15900113|NCT03648840|Behavioral|Neutral cue|Participants will be exposed to neutral pictures and tones during performance of a task to earn alcohol
15900114|NCT03648827|Drug|Ataluren|Ataluren will be administered as per the dose and schedule specified in the arm.
15900115|NCT03648814|Procedure|Intracameral injection|A/C injection of 1.25 mg/0.05 mL bevacizumab
15900116|NCT03648814|Procedure|Intravitreal injection|Vitreous injection of 1.25 mg/0.05 mL bevacizumab
15900117|NCT03648788|Other|NA (Observation study)|NA (Observation study)
15900118|NCT03648775|Device|Y-STRUT® (Hyprevention, Pessac, France)|The studied medical device consists of two components implanted in the proximal femur, combined with bone cement.
15900119|NCT03648762|Behavioral|Aerobic Exercise Intervention|Aerobic Exercise Intervention - 12 weeks of a minimum of 3 days a week for 60 minutes of aerobic exercise
15900120|NCT03648762|Behavioral|Combined Aerobic and Strength Exercise Intervention|Combined Aerobic and Strength Exercise Intervention- 12 weeks of a minimum of 3 days a week for 60 minutes of Combined Aerobic and Strength Exercise
15900121|NCT03648762|Behavioral|Inspiratory Muscle Training Exercise Intervention|Inspiratory Muscle Training Exercise Intervention- 12 weeks of a minimum of 3 days a week for 60 minutes of Inspiratory Muscle Training Exercise
15900122|NCT03648749|Behavioral|Speech-to-noise feedback|A target speech-to-noise level is specified and feedback about achievement of the target level is provided.
15900123|NCT03648736|Other|blood withdrawal|"peripheral-venous before TASH, day 1, 2, 3, one week and one month after TASH procedure
~central-venous during TASH"
15900124|NCT03648710|Other|Peer Community Health Worker|Participants will be communicating with their CHWs on a weekly basis, which is consistent with other successful community health worker protocols with published efficacy. Community Health Workers will be peers with sickle cell disease, who have successfully transitioned and are under 30 years of age.
15900125|NCT03648710|Other|Mobile Health|A mobile health application created as a resource for young adults transitioning.
15900126|NCT03648697|Biological|EBV-TCR-T (YT-E001) cells|"EBV-TCR-T (YT-E001) cells are prepared via lentiviral infection. 6-10 days prior to infusion of TCR-T cells (YT-E001), subjects receive fludarabine at dose 30mg/m2/day for 4 days and cyclophosphamide treatment at dose 30mg/kg/day for 2 days and take a rest for one day before infusion.
~Patients, who receive an infusion of YT-E001, will remain in the hospital to be monitored for adverse events until they have recovered from the treatment. Patients will have frequent follow-up visit to monitor the persistence of modified T cells and efficacy of the treatment."
15900127|NCT03648684|Behavioral|Caffeine-Based Expectancy Challenge|Intervention to alter expectancies and encourage safe drug substitution (harm reduction plus expectancy modification)
15900128|NCT03648684|Behavioral|Placebo-Based Expectancy Challenge|Intervention to alter expectancies (expectancy modification only)
15900129|NCT03648671|Drug|safinamide metansolfonato (12 weeks)|safinamide metansolfonato
15900130|NCT03648671|Drug|safinamide metansolfonato (12 weeks)|safinamide metansolfonato
15900131|NCT03648671|Drug|rasagilina mesilato (12 weeks)|rasagilina mesilato
15900132|NCT03648671|Drug|rasagilina mesilato (12 weeks)|rasagilina mesilato
15900133|NCT03648658|Drug|Paracetamol 120Mg/5mL Oral Suspension|The subjects will be treated with paracetamol in therapeutic doses, 15mg/kg/dose every six hour, with a maximum dosage of 1 g x 4 per day, for three consecutive days.
15900134|NCT03648645|Device|Self measurement of blood pressure|"Patients will perform the measurement of blood pressure at home, on a daily basis, in complying with the rule of 3 stated by the Haute Autorité de Santé (French Health Authority) : i.e. 3 consecutive measurements in the morning and in the evening, after a period of rest Measurements are performed using a blood pressure monitor Bluetooth-connected. If a threshold value is exceeded (and depending on the alert), a consultation will be scheduled (unexpected consultation) and notified to the patient."
15900135|NCT03648632|Radiation|Stereotactic Radiotherapy|Patients should be treated with 50 Gy in 5 fractions within a total of 7 - 8 days.
15900136|NCT03648619|Diagnostic Test|Semi whole-body MRI|Single semi-automatic, semi whole-body MRI protocol (Dot engine)
15900137|NCT03648606|Other|mesure of skin temperature|"The infants are placed in a closed incubator to study the variability of the heart and respiratory frequencies according to the regulation of the incubator and to quantify the time spent outside. Data will be collected during the first 10 days of life of the preterm infant. Skin temperatures at six body sites (the abdomen, pectoral region, eye, hand, thigh and foot) were measured (using infrared thermography) during nocturnal polysomnography in 29 9-day-old preterm neonates (postmenstrual age:
~209 9 days). The investigators then determined whether the duration of the W episode depended upon the local skin temperatures measured at the start, during and end of the episode."
15900138|NCT03648593|Behavioral|work recovery intervention|Recover! app: one hour weekly for two months
15900139|NCT03648593|Behavioral|waiting list control|no treatment during 6 months,then Recover! app
15900140|NCT03648580|Dietary Supplement|Ensure Complete powder|Supply the Ensure Complete powder that will be the oral nutrition supplement, with the dose of 6 scoops (53.8 grams) twice daily.Duration: 12 weeks
15900141|NCT03648580|Other|verbal nutrition education|give the verbal nutrition education
15900142|NCT03648554|Drug|dulaglutide (TRULICITY®) 1.5 mg|dulaglutide (TRULICITY®) 1.5 mg subcutaneous administration, one weekly injection over 52 weeks of treatment
15900143|NCT03648554|Other|reinforced dietary monitoring|moderate caloric restriction individually adjusted according to the ideal weight and activity level, encouraging regular physical activity (about 30 minutes per day or 150-200 min per week)
15900146|NCT03648528|Drug|cholecalciferol|
15900147|NCT03648528|Drug|placebo|
15900148|NCT03648515|Diagnostic Test|Plaster models|The impressions taken of the dental arches will be poured with hard gypsum in order to make use of the models for taking measurements. These measurements will be considered the gold standard.
15900149|NCT03648515|Diagnostic Test|Digital Images of the dental arches|The dental arches will be captured using a dedicated camera in order to be used for measuring the outcomes.
15900150|NCT03648515|Diagnostic Test|Digital images of models|The poured dental models will be captured using a dedicated camera in order to be used for measuring the outcomes.
15900151|NCT03648502|Diagnostic Test|Cognitive tests and hearing tests|Several cognitive and hearing (peripheral and (central) auditory process) tests
15900152|NCT03648489|Drug|Paclitaxel|Please refer to arm/group description
15900153|NCT03648489|Drug|TAK228|Please refer to arm/group description
15900154|NCT03648476|Behavioral|ICAN|A 6-week group therapy sessions once a week for 90-120 minutes.
15900155|NCT03648463|Procedure|arthroscopy of the affected knee/ Bone Marrow Concentrate Injection|Subjects will undergo knee arthroscopy for debridement, menisectomy and synovectomy of the cartilage defects. Subjects will also be injected with bone marrow aspirate concentrated harvested from the pelvis and centrifuged (produced produced using the Harvest/Terumo BCT system)
15900156|NCT03648450|Other|Hailie Smart Inhaler EMD|Hailie Smart Inhaler electronic monitoring device is a sleeve that fits over inhalers and uses Bluetooth connection to cell phones to remind patients to take their medication.
15900157|NCT03648437|Drug|Paracetamol 10Mg/mL|Experimental drug
15900158|NCT03648437|Drug|0.45% Sodium Chloride|Placebo comparator
15900159|NCT03648437|Drug|Ibuprofen|Standard therapy
15900160|NCT03648437|Drug|Indomethacin|Standard therapy
15900161|NCT03648411|Genetic|Drug resistance molecular markers|Proportion of the drug resistance molecular markers will be found-out and compared.
15900162|NCT03648398|Other|EDUMICILOR|Patients will participate in the online therapeutic education program for about 6 months
15900163|NCT03648385|Drug|DHEA tablet|DHEA tablet (50 mg) taken by mouth once a day for 18 weeks.
15900164|NCT03648385|Other|Placebo|1 placebo tablet taken by mouth once a day for 18 weeks
15900165|NCT03648372|Drug|TAK-981|Intravenous infusion.
15900166|NCT03648359|Procedure|multiparametric MRI Diagnostics|Patients with newly diagnosed prostate cancer enrolled in active surveillance following standard protocol including PSA, DRE and TRUS biopsies and intervention with multiparametric MRI + additional biopsies if suspicious lesions are found
15900167|NCT03648346|Drug|Cohort 1: HL217 Ophathalmic Solution BID|Two drops of 3 mg/mL of the treatment in one eye twice a day
15900168|NCT03648346|Drug|Cohort 2: HL217 Ophathalmic Solution QID|Two drops of 3 mg/mL of the treatment in one eye 4 times a day
15900169|NCT03648346|Drug|Placebo|Placebo eye drops
15900170|NCT03648333|Drug|Exforge tab. 10/160mg|
15900171|NCT03648333|Drug|Lodivixx tab. 5/160mg|
15900172|NCT03648320|Other|Peanut oral immunotherapy|Daily doses of peanut flour (with 2-weekly incremental interval)
15900173|NCT03648307|Diagnostic Test|Blood sample|Blood sample for Hb A1C and lipid profile, blood pressure and BMI
15900174|NCT03648294|Other|adrenalectomy for primary addosteronism|All of the clinical and biological data were retrospectively compiled from the patient computerized record. The variables analyzed were: age, sex, body mass index (BMI), PAH discovery circumstances, pre- and postoperative systolic and diastolic blood pressure assessments, number of pre-hypertensive antihypertensive drug - and postoperatively, the laterality, the size and nature of the lesions, the operating time, the surgical technique used. The biological data evaluated were pre- and postoperative plasma and plasma creatinine, preoperative serum aldosterone concentrations, plasma renin activity, and preoperative aldosterone / renin ratio. Hypokalemia was defined as serum concentration below 3.5 mmol / L.
15900175|NCT03648281|Drug|Semaglutide|Patients will be treated with commercially available semaglutide in a prefilled pen injector (FlexTouch® variant) according to routine local clinical practice at the discretion of the treating physician. Other anti-hyperglycaemic treatments will be prescribed at the physician's discretion.
15900176|NCT03648268|Device|repetitive Transcranial Magnetic Stimulation (rTMS)|"rTMS is a technique of TMS that allows the selective external manipulation of neural activity in a non-invasive manner. During TMS, a rapidly changing current is passed through an insulated coil placed against the scalp. This generates a temporary magnetic field that in turn induces electrical current in neurons and allows the modulation of neural circuitry. The combination of TMS with fMRI allows the selective targeting and modulation of brain networks. The repeated application of rTMS can cause long term changes in behavior and task performance that is reflected in altered brain network connectivity.
~The pattern of rTMS will consist of either:
~intermittent Theta Burst Stimulation (iTBS) pattern consisting of 2 s trains of 3 pulses at 50 Hz, repeated at 5 Hz, every 10s for a total of 600 pulses.
~OR
~sham stimulation"
15900177|NCT03648242|Behavioral|Interruptive Clinical Decision Support|"An interruptive, soft-stop alert will pop up when a pediatric primary care provider open a child's electronic health record (i.e., a new window in the forefront of the screen interrupting workflow and requiring the clinician to take an action) alerting them that the child meets criteria for obesity based on their age/sex-specific BMI percentile. The pop-up alert includes:
~One-click addition of elevated BMI to problem list
~Reminder to utilize Suggested PowerPlan
~One-click access to a patient handout on evidence-based behavior change goals (screen time, sugary drinks, physical activity, sleep) and link to additional handouts and resources
~Tables displaying trends in growth measures, blood pressure and relevant laboratory tests
~Links to existing, evidence-based childhood obesity screening and management guidelines"
15900178|NCT03648229|Procedure|Selective laser trabeculoplasty (SLT)|Delivery of laser energy to the trabecular meshwork of the eye with the goal of reducing intraocular pressure
15900179|NCT03648229|Drug|Latanoprost ophthalmic solution|Prostaglandin analogue topical ophthalmic medication for reduction of intraocular pressure
15900507|NCT03645746|Drug|Placebo|Placebo-matching REGN5069
15900181|NCT03648216|Behavioral|HAPA behavioural counseling|Behavioural counseling grounded in the Health Action Process Approach (HAPA; i.e., action planning and coping planning) to maximize sedentary behaviour and minimize steps taken.
15900182|NCT03648203|Behavioral|Technology Enabled Asthma Management System|See description of arm
15900183|NCT03648190|Diagnostic Test|Flowcytometry analysis of platelets surface receptors|"BD FACSCalibur flowcytometry instrument.
~Platelet flow cytometry is an emerging tool in diagnostic and therapeutic hematology. It is eminently suited to study the expression of platelet surface receptors both qualitatively as well as quantitatively.
~Flow cytometry rapidly measures the specific characteristics of a large number of cells in suspension. Typically, the cells are labeled with fluorescently conjugated monoclonal antibodies (mAbs)."
15900184|NCT03648177|Behavioral|IPGT|Behavioral Intervention for Patients with Chronic Pain
15900185|NCT03648177|Behavioral|Treatment as Usual|Standard Care
15900186|NCT03648164|Other|CHAT-CS Survey|Students will complete a computer-based survey
15900187|NCT03648138|Behavioral|Sugary drink warning labels|This information appears in the description of the study arms.
15900188|NCT03648125|Device|with artificial occlusal disturbance|"A silicon artificial occlusal disturbance is made from a mould of the rowers mouth and placed in the mouth during the training session.
~With artificial occlusal disturbance : Maximal Intercuspal Occlusion (MIO) with silicone splint increases the vertical dimension of occlusion of 1, 2 and 4 mm."
15900189|NCT03648125|Device|without artificial occlusal disturbance|The training session is performed without occlusal disturbance
15900190|NCT03648112|Dietary Supplement|Intervention 1|The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of crude oat flakes per day.
15900191|NCT03648112|Dietary Supplement|Intervention 2|The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of roasted oat flakes per day.
15900192|NCT03648112|Dietary Supplement|Intervention 3|The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of crude barley flakes per day.
15900193|NCT03648112|Dietary Supplement|Intervention 4|The study participants receive recipes for breakfast for 21 days. The recipes imply 80 g of roasted barley flakes per day.
15900194|NCT03648112|Dietary Supplement|Control|"White toastbread (control) (dietary supplement) White toastbread was chosen because of its low fibre content. To achieve the same energy value (kcal) as 80 g cereal flakes the participants have to consume four slices of white toastbread.
~The study participants receive recipes for breakfast for 21 days. The recipes imply four slices of white toastbread."
15900195|NCT03648099|Behavioral|Labor dance|The dance group which involved pregnant women who performed the labor dance
15900196|NCT03648099|Behavioral|Music|The music group involving pregnant women who were exposed to music.
15900197|NCT03648086|Other|intestinal microbiota transplantation|Participants in Exprerimental group take 6 times IMT with 2-week intervals
15900198|NCT03648073|Diagnostic Test|[68Ga]DOTATATE-PET/MRI|[68Ga]DOTATATE-PET/MRI
15900199|NCT03648060|Device|Digital kinematic biofeedback system|The system will be used independently by the patients to perform rehabilitation sessions at home, under remote monitoring from the clinical team. A tailored rehabilitation program will be prescribed by the therapist and edited according to patient evolution.
15900200|NCT03648047|Device|Digital kinematic biofeedback device|The system will be used independently by the patients to perform rehabilitation sessions at home, under remote monitoring from the clinical team.
15900201|NCT03648047|Other|Conventional rehabilitation|Patients will receive conventional face-to-face sessions by a Physical Therapist.
15900202|NCT03648047|Other|Additional face-to-face rehabilitation sessions|Patients will receive face-to-face sessions in addition to sessions performed with the Digital Rehabilitation Device
15900203|NCT03648034|Procedure|ropivacaine|To perform scalp nerve blocks with ropivacaine
15900204|NCT03648034|Procedure|saline|To perform scalp nerve blocks with saline
15900205|NCT03648021|Drug|Paracetamol|">50kg: Paracetamol 1 gramme in a solution of 10mg/mL administred intravenously. 1 dose
~>50kg: Paracetamol 15mg/kg/dose in a solution 10mg/mL administred intravenously. 1 dose"
15900206|NCT03648021|Drug|Placebo|100mL of chlorure de sodium 0.9% administred intravenously. 1 dose
15900207|NCT03648008|Drug|Hydromorphone|0.002 mg*kg-1 bolus with 0.002 mg*kg-1 background infusion for group BH 0.002 mg*kg-1 bolus without background infusion for group NBH Drug is administered through PCIA pump.
15900208|NCT03648008|Drug|Morphine|0.015 mg*kg-1 bolus without background infusion for group M Drug is administered through PCIA pump.
15900209|NCT03647995|Dietary Supplement|Probiolife by Green Made (Pharma M)|A box containing 30 capsules of a dietary supplement containing 25 Bn CFU (detailed in previous sections)
15900210|NCT03647995|Other|Placebo|A box containing 30 capsules containing an inactive substance with 0 Bn CFU.
15900211|NCT03647982|Drug|Meditoxin|injection of MEDITOXIN into the intradermal of each contralateral upper back in equal doses
15900212|NCT03647982|Drug|Botox|injection of Botox into the intradermal of each contralateral upper back in equal doses
15900213|NCT03647969|Drug|Nivolumab|"Nivolumab 240mg Flatdose i.v. d1 over 30 minutes every 2 weeks"
15900214|NCT03647969|Drug|Ipilimumab|1mg/kg i.v. d1 over 30 minutes every 6 weeks
15900215|NCT03647969|Drug|mFOLFOX|Oxaliplatin at a dose of 85 mg/m² iv over two hours (day 1), Leucovorin at a dose of 400 mg/m2 iv over two hours (day 1), Fluorouracil at a dose of 400 mg/m² iv bolus (day 1), and Fluorouracil at a dose of 2400 mg/m² iv continuous infusion over 44 hours (day 1+2) every 2 weeks
15900216|NCT03647969|Drug|FLOT|"Docetaxel at a dose of 50 mg/m² iv over one hour (day 1), Oxaliplatin at a dose of 85 mg/m² iv over two hours (day 1), Leucovorin* at a dose of 200 mg/m² iv over one hour (day 1), Fluorouracil at a dose of 2600 mg/m² iv over 24 hours (day 1) every 2 weeks
~* Note: Leucovorin can be replaced by sodium folinate that is given according to local guideline."
15900217|NCT03647956|Drug|Atezolizumab|Atezolizumab (trade name Tecentriq) is a fully humanized, engineered monoclonal antibody of IgG1 isotype against the protein programmed cell death-ligand 1 (PD-L1).
15900218|NCT03647956|Drug|Bevacizumab|Bevacizumab is a recombinant humanized monoclonal antibody that blocks angiogenesis by inhibiting vascular endothelial growth factor A (VEGF-A).
15900219|NCT03647956|Drug|Carboplatin|Carboplatin, sold under the trade name Paraplatin among others, is a chemotherapy medication used to treat a number of forms of cancer.
15900788|NCT03643627|Drug|Placebo|single IV infusion
15900220|NCT03647956|Drug|Pemetrexed|Pemetrexed (brand name Alimta) is a chemotherapy drug manufactured and marketed by Eli Lilly and Company. Its indications are the treatment of pleural mesothelioma and non-small cell lung cancer.
15900221|NCT03647943|Device|Transcranial direct current stimulation|Transcranial direct current stimulation, involving low-levels of electrical stimulation applied to the right and left DLPFC will be used in conjunction with cognitive training for 46 minutes.
15900222|NCT03647943|Device|Sham transcranial direct current stimulation|Sham transcranial direct current stimulation, involving no electrical stimulation will be used in conjunction with cognitive training for 46 minutes.
15900223|NCT03647930|Device|Microporous Polysaccharide Hemospheres (MPH)|Microporous Polysaccharide Hemospheres (MPH)
15900224|NCT03647917|Biological|Platelet Rich Plasma|"Autologous Platelet Rich Plasma (PRP) will be isolated from the blood collected from each subject at each treatment time point.
~Face: Using a 30 gage needle, about four points of PRP or saline will be injected into the malar area; about six points will be injected into the mandibular area; and seven points will be injected into the forehead (0.2 mL per point) with a total volume of approximately 3.5 mL. PRP and saline application will be followed by microneedling.
~Hands: Using a 30 gage needle about 1 cc of PRP or saline will be injected into the dorsal area of the hands (0.2mL per point) at five points. No microneedling will be performed on the hands."
15900225|NCT03647917|Biological|Platelet Rich Plasma|"Autologous Platelet Rich Plasma (PRP) will be isolated from the blood collected from each subject at each treatment time point.
~Face: Using a 30 gage needle, about four points of PRP or saline will be injected into the malar area; about six points will be injected into the mandibular area; and seven points will be injected into the forehead (0.2 mL per point) with a total volume of approximately 3.5 mL. PRP and saline application will be followed by microneedling.
~Hands: Using a 30 gage needle about 1 cc of PRP or saline will be injected into the dorsal area of the hands (0.2mL per point) at five points. No microneedling will be performed on the hands."
15900226|NCT03647904|Behavioral|SEMS Project|TThe intervention is a culmination of five empirically supported interventions: (1) The MS Wellness Program aimed at developing lifestyle strategies to enhance quality of living and cope with various aspects of MS; (2) The FACETS intervention, which aims to reduce fatigue and improve self-efficacy; (3) The Modified Story Memory technique, which improves new learning and memory; (4) The Speed of Processing training, which improves performance on measures of processing speed in persons with MS. Finally, the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders, a cognitive behavioral intervention, which improves psychological functioning and functional outcomes.
15900227|NCT03647891|Device|Continuous Positive Airway Pressure|CPAP is an FDA approved therapy machine for patients diagnosed with OSA. CPAP provides positive air pressure to the patients throat to ensure the patients airway stays open during sleep. CPAP is the gold standard treatment for OSA, but there is limited research that demonstrates whether or not CPAP can improve clinical outcomes in patients with cardiovascular disease. Therefore, our investigators plan to initiate CPAP therapy in patients hospitalized for cardiovascular disease to investigate whether there is an improvement in cardiac function and clinical outcomes (e.g. mortality).
15900228|NCT03647865|Procedure|Osseous Genioplasty|Surgical Procedure that cuts the chin and reposition it in the correct place
15900229|NCT03647852|Drug|Methylprednisolone|1.methylprednisolone pulse (15-30mg/kg/d) for 3 days with continued oral prednisolone(2mg/kg/d) 2.if the patients still complain abdominal pain and feel abdominal tenderness on the third day after intervention , patients would be given IVIG(2g/kg/d)as a change
15900230|NCT03647852|Drug|IVIG|1. IVIG 2g/kg and oral prednisolone 2mg/kg/d 2.if the patients still complain abdominal pain and feel abdominal tenderness on the third day after intervention , patients would be given methylprednisolone pulse (15-30mg/kg/d) for 3 days
15900231|NCT03647852|Drug|other basic supportive treatment|"Omeprazole 0.8mg/kg.d.The maximum dose is less than 40mg per day
~Low molecular weight heparin calcium 50IU/kg.d"
15900232|NCT03647839|Drug|Nivolumab 10 MG/ML|Nivolumab will be supplied free of charge by Bristol-Myers Squibb (BMS) as sterile liquid in 10mL glass vials.
15900233|NCT03647839|Drug|BNC 105|BNC105 will be provided free of charge by Bionomics, as a sterile solution of BNC105P. BNC105P is a clear, colorless to yellow liquid presented in a clear glass vial and is intended to be diluted with commercially available sterile 0.9% saline prior to IV administration.
15900234|NCT03647839|Drug|BBI608|BBI-608 will be supplied free of charge by Boston Biomedical as capsules.
15900235|NCT03647826|Behavioral|Mind Power Intervention|The intervention has a total sample of 110 schoool classes, which are devided in two arms: Mind Power Intervention Group 1 or Mind Power Intervention Group 2
15900236|NCT03647813|Radiation|Photobiomodulation|Patients received three irradiations of laser at ʎ = 808 nm, 100 mW, 142 J/cm2 and 4 J per point.
15900237|NCT03647813|Radiation|Placebo|The same laser protocol was followed but with the device switched off.
15900238|NCT03647800|Biological|APVO436|APVO436
15900239|NCT03647787|Other|observational study|This study is a longitudinal observational study
15900240|NCT03647774|Drug|Extended release naltrexone|380mg injectable extended release naltrexone every four weeks
15900241|NCT03647761|Device|Tetra-grip|Tetra-grip is a tubular elastic bandage that provides both compression and support
15900242|NCT03647748|Device|Sham Comparator|A modified device utilizing a pigtail connector to bypass active treatment.
15900243|NCT03647735|Other|patient-controlled sedation|Patient-controlled propofol boluses for patients undergoing elective orthopaedic surgery under central neuraxial block
15900244|NCT03647722|Other|Assessment of leukocyte function.|The function and phenotype of regulatory B-cells, regulatory T-cells and alternatively-activated monocytes will be assessed directly ex vivo from PBMC.
15900245|NCT03647709|Other|opioids|dosage frequency and duration
15900246|NCT03647683|Other|Self-Compassion|"Participants are introduced to the concept of self-compassion. Treating oneself with kindness, while being mindfully aware of the present moment as well as the fact that suffering is part of human life - a shared human experience.
~Participants are instructed to use this strategy to cope with the following heat stimulus."
15900247|NCT03647683|Other|Acceptance|"Participants are introduced to the concept of acceptance. Thoughts, Emotions and Reactions do not need to be related. Being aware of the present moment helps with accepting the present state and reacting contradictory to the thoughts and feelings.
~Participants are instructed to use this strategy to cope with the following heat stimulus."
15900248|NCT03647683|Other|Distraction|"Participants are introduced to the concept of distraction. Distracting oneself from the present situation helps with not perceiving pain, painful thoughts or feelings.
~Participants are instructed to use this strategy to cope with the following heat stimulus."
15900249|NCT03647683|Other|Heat pain|Participants receive heat pain stimuli using the Thermo Sensory Analyser (TSA-II), a commonly used device to study pain sensation and analgesic effects.
15900250|NCT03647670|Drug|PF-04965842|orally bioavailable small molecule that selectively inhibits JAK1 by blocking the adenosine triphosphate (ATP) binding site.
15900251|NCT03647670|Drug|Midazolam|substrate which undergoes extensive metabolism by CYP3A4 and CYP3A5 and acts as a sensitive probe for evaluating drug interaction with respect to these isoenzymes
15900252|NCT03647657|Drug|177Lu-PP-F11N|Intravenous application of 2 x 1 gigabequerel (GBq) 177Lu-PP-F11N with and without co-medication with Sacuitril (100 mg Entresto) in each patient
15900253|NCT03647657|Drug|Sacuitril|Medication with Sacuitril (100 mg Entresto) additional to the injection of 177Lu-PP-F11N
15900254|NCT03647644|Diagnostic Test|Coagulation Laboratory Testing|Standard coagulation testing (Platelet count, Fibrinogen, PT/INR, aPTT), and Thromboelastogram as is routine and per institutional protocol in this population.
15900255|NCT03647631|Procedure|sentinel lymph node biopsy|Authors discuss a possible usefulness of SNLB for staging and diagnosis in porocarcinoma.
15900256|NCT03647618|Other|Ultrasound|Ultrasound-guided regional anaesthesia
15900257|NCT03647605|Behavioral|VR Mind|"Two VR Mind sessions using virtual reality scenarios concerning social situations in which social phobics are prone to experience anxiety. The pilot study will consist of two scenarios: Public Speaking in Lecture Hall and Telephoning in Public. Two sessions are planned, each containing two expositions to virtual reality environment, each lasting 10 minutes."
15900258|NCT03647592|Drug|Erlotinib/Gefitinib combined with Bevacizumab|Erlotlnib,150mg po qd/gefitinib 250mg po qd +Bevacizumab(15mg/kg),lvgtt,every 21 day ,evaluate every 2 months
15900259|NCT03647579|Drug|midazolam intravenous infusion of 0.05 mg/kg plus 1 mg/kg ketamine|midazolam intravenously (i.v.) in a dose of 0.05 mg/kg diluted by 50ml saline over 10 minutes using syringe pump plus 1 mg/kg ketamine
15900260|NCT03647579|Drug|Dexmedetomidine intravenous infusion of 2mic/kg plus 1 mg/kg ketamine|Dexmedetomidine intravenously (i.v.) in a dose of 2mic/kg diluted by 50ml saline over 10 minutes using syringe pump plus 1 mg/kg ketamine
15900261|NCT03647566|Diagnostic Test|18F Sodium Fluoride Positron Emission Tomography / Computed Tomography|PET scan using the 18F-Sodium Fluoride radiotracer followed by an attenuation correction CT scan
15900262|NCT03647566|Diagnostic Test|CT Aortic Angiogram|CT scan to assess aortic morphology and contextualise PET scan
15900263|NCT03647566|Diagnostic Test|Aortic MRI|Aortic MRI to assess aortic morphology and contextualise PET scan
15900264|NCT03647540|Procedure|fluorescent laparoscopic radical gastrectomy|The gastrectomy for group F would be underwent by the fluorescence laparoscopy. All surgical procedures will be performed by the surgery team ,which is leaded by professor Wang Quan.
15900265|NCT03647540|Procedure|traditional laparoscopic radical gastrectomy|The gastrectomy for group L would be underwent by the laparoscopy.All surgical procedures will be performed by the surgery team ,which is leaded by professor Wang Quan.
15900266|NCT03647514|Drug|Abraxane|Tailored neoadjuvant chemotherapy with 4 cycles of PX(weekly Abraxane 125mg/m2, Q3week Xeloda 1250mg/m2, 21day/cycle) is planned for early breast cancer patients(stage of T2-4N0-3M0) who are eligible for primary systemic therapy.
15900267|NCT03647514|Drug|Xeloda|Tailored neoadjuvant chemotherapy with 4 cycles of PX(weekly Abraxane 125mg/m2, Q3week Xeloda 1250mg/m2, 21day/cycle) is planned for early breast cancer patients(stage of T2-4N0-3M0) who are eligible for primary systemic therapy.
15900268|NCT03647501|Device|Interbody cage (titanium)|Subject will be implanted with a 3D-printed titanium cage during their lumbar interbody fusion surgery.
15900269|NCT03647501|Device|Interbody cage (PEEK)|Subject will be implanted with a poly-ether-ether-ketone (PEEK) cage during their lumbar interbody fusion surgery.
15900273|NCT03647475|Combination Product|Device: Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by one-month DAPT|To evaluate the clinical safety of the Resolute Onyx stent with use of one-month DAPT in subjects deemed at high risk for bleeding and/or medically unsuitable for more than one-month DAPT treatment.
15900274|NCT03647462|Device|Continuous Positive Airway Pressure|CPAP is an FDA approved therapy machine for patients diagnosed with OSA. CPAP provides positive air pressure to the patients throat to ensure the patients airway stays open during sleep. CPAP is the gold standard treatment for OSA, but there is limited research that demonstrates whether CPAP can improve clinical outcomes in patients with COPD. Therefore, our investigators want to initiate CPAP therapy in patients hospitalized for COPD to investigate whether there is an improvement in cardiac function and clinical outcomes (i.e. mortality).
15900275|NCT03647449|Dietary Supplement|Juice|Participants will be drinking 800-900 kcal/day in cold-pressed juices.
15900276|NCT03647449|Behavioral|Caloric restriction via Plant-based meals|Participants' caloric intake will be limited to 800-900 kcal/day.
15900277|NCT03647449|Dietary Supplement|Plant-based meal|Participants will be eating ~900 kcal/day in pre-prepared plant-based meals.
15900278|NCT03647436|Other|Comprehensive Geriatric Assessment. Both groups.|Evaluation of the incidence of geriatric syndromes: depression, delirium, cognitive disorders, falls, gait disturbances, urinary and fecal incontinence
15900279|NCT03647423|Biological|Aldoxorubicin Hydrochloride|Aldoxorubicin Hydrochloride HCI
15900280|NCT03647423|Biological|ALT-803|Recombinant human super agonist interleukin-15 (IL-15) complex
15900281|NCT03647423|Biological|ETBX-051|Ad5 [E1-, E2b-]-Brachyury
15900282|NCT03647423|Biological|ETBX-061|Ad5 [E1-, E2b-]-mucin 1 [MUC1]
15900283|NCT03647423|Biological|GI-6301|Brachyury yeast
15900284|NCT03647423|Biological|haNK|haNK™, NK-92 [CD16.158V, ER IL-2]
15900285|NCT03647423|Drug|Avelumab|injection
15900286|NCT03647423|Drug|Cetuximab|Injection
15900287|NCT03647423|Drug|Cyclophosphamide|Capsules
15900288|NCT03647423|Radiation|SBRT|Stereotactic body radiation therapy
15900289|NCT03647410|Device|lumbopelvic fixation|Sacral fractures fixed with lumbopelvic fixation or novel adjustable plate were divided into two groups. Surgical time, intraoperative blood loss, frequency of intraoperative fluoroscopy, reduction quality, related complications, and functional outcome were reviewed.
15900290|NCT03647397|Device|Photo Electrochemical Oxidation (PECO) for Air Purification|PECO air purifiers from Molekule will be placed in every patient room. Health metrics will be tracked for patients whose diagnosis is respiratory distress.
15900291|NCT03647384|Drug|Gulingji capsules|Patients take 0.6g of Gulingji capsules, 2 hours before breakfast, served with light salt water once a day. Also an oral take of 19.2mg Ginko Biloba Extract mimetic three times a day. Treatment lasts for 24 weeks.
15900292|NCT03647384|Drug|Ginko Biloba Extract tablet|Patients take 0.6g of Gulingji mimetic, 2 hours before breakfast, served with light salt water once a day. Also an oral take of 19.2mg Ginko Biloba Extract tablet three times a day. Treatment lasts for 24 weeks.
15900293|NCT03647371|Procedure|Macintosh laryngoscopy|intubation with MAcintosh laryngoscopy after anesthetic induction
15900294|NCT03647371|Procedure|McGrath MAC video laryngoscopy|intubation with McGrath MAC videolaryngoscopy after anesthetic induction
15900295|NCT03647358|Device|PET/CT Scan|Up to four whole-body PET scans (approximately 24, 48, and 120 hours post 124I oral dose) will be performed on one of the GE Discovery 710 or 690 PET scanners.
15900296|NCT03647358|Drug|Iodine-124|Patients will receive 0.9 mg injections of rhTSH on two consecutive days. Twenty-four hours after the last injection of rhTSH each patient will receive approximately 5 mCi (range: 4-7 mCi) of 124I orally as a single dose.
15900297|NCT03647345|Device|High-frequency rTMS on left DLPFC+anodal tDCS on right DLPFC|10Hz rTMS over the left DLPFC and anodal tDCS over the right DLPFC are simultaneously stimulated.
15900298|NCT03647345|Device|High-frequency rTMS on left DLPFC+cathodal tDCS on right DLPFC|10Hz rTMS over the left DLPFC and cathodal tDCS over the right DLPFC are simultaneously stimulated.
15900299|NCT03647345|Device|High-frequency rTMS on left DLPFC+sham tDCS on right DLPFC|10Hz rTMS over the left DLPFC and sham tDCS (no stimulation) over the right DLPFC are simultaneously stimulated.
15900300|NCT03647332|Procedure|Cooled RFA treatment|cooled radiofrequency ablation
15900301|NCT03647332|Drug|Steroid Drug|steroid injection
15900302|NCT03647319|Device|High-frequency rTMS on left DLPFC+anodal tDCS on right DLPFC|10Hz rTMS over the left DLPFC and anodal tDCS over the right DLPFC are simultaneously stimulated.
15900303|NCT03647319|Device|High-frequency rTMS on left DLPFC+cathodal tDCS on right DLPFC|10Hz rTMS over the left DLPFC and cathodal tDCS over the right DLPFC are simultaneously stimulated.
15900304|NCT03647319|Device|High-frequency rTMS on left DLPFC+sham tDCS on right DLPFC|10Hz rTMS over the left DLPFC and sham tDCS (no stimulation) over the right DLPFC are simultaneously stimulated.
15900305|NCT03647306|Behavioral|Early Total Caloric Intake|Provide subjects a regimented amount of calories at each meal.
15900306|NCT03647306|Behavioral|Late Total Caloric Intake|Provide subjects a regimented amount of calories at each meal.
15900307|NCT03647306|Behavioral|Extended Overnight Fast|Provide subjects a regimented amount of calories at each meal.
15900308|NCT03647293|Procedure|Ultrasound Guided Central Catheter Insertion|
15900309|NCT03647293|Procedure|Peripherally Inserted Central Catheter|
15900310|NCT03647280|Drug|Abraxane|Tailored neoadjuvant chemotherapy with 4 cycles of PE(weekly Abraxane 125mg/m2, Q3week Epirubicin 100mg/m2, 21day/cycle) is planned for early breast cancer patients(stage of T2-4N0-3M0) who are eligible for primary systemic therapy.
15900311|NCT03647280|Drug|Epirubicin|Tailored neoadjuvant chemotherapy with 4 cycles of PE(weekly Abraxane 125mg/m2, Q3week Epirubicin 100mg/m2, 21day/cycle) is planned for early breast cancer patients(stage of T2-4N0-3M0) who are eligible for primary systemic therapy.
15900314|NCT03647254|Behavioral|Patient education group|Group meetings with educational sessions will be organised in health center. A group educational intervention was practiced to half of the patients, by one expert patient, so that every patient must attend to one group meeting
15900315|NCT03647241|Device|Self-Ligating Brackets|These brackets can be opened and closed through the use of a sliding cap embedded into the design of these brackets. There is no need to use elastic modules to ligate the arch.
15900316|NCT03647241|Device|Traditionally-Ligated Brackets|These brackets are used in the conventional manner, where the orthodontist is obliged to use elastic modules to engage the arch into the slot of the bracket.
15900317|NCT03647241|Procedure|Corticotomy|Corticotomy without flap elevations will be performed in order to induce acceleration in tooth movement during the orthodontic treatment in only one group.
15900318|NCT03647228|Drug|IONIS-ENaCRx|Ascending single and multiple doses of IONIS-ENaCRx inhaled or nebulized.
15900319|NCT03647228|Drug|Placebo|Placebo comparator calculated volume to match active comparator inhaled or nebulized.
15900320|NCT03647202|Drug|Milademetan Treatment A|Treatment A: Single oral dose of milademetan 160 mg capsules under fasted conditions
15900321|NCT03647202|Drug|Milademetan Treatment B|Treatment B: Single oral dose of milademetan 160 mg capsules with a high-calorie, high-fat meal
15900322|NCT03647202|Drug|Milademetan Treatment C|Treatment C: Single oral dose of milademetan 160 mg capsules with a standard meal.
15900323|NCT03647189|Device|Hybrid Fractional Laser|Hybrid Fractional Laser
15900324|NCT03647176|Other|Cold snare polypectomy|cold snare polypectomy (CSP), which does not include electrocautery to do a polypectomy with a snare
15900325|NCT03647163|Biological|VSV-IFNβ-NIS|Intravenous oncolytic Vesicular stomatitis virus (VSV) expressing Interferon-beta (IFNβ) and the sodium iodide symporter (NIS)
15900326|NCT03647163|Biological|Pembrolizumab|Pembrolizumab
15900327|NCT03647150|Drug|amoxicillin|At enrollment the child will receive a 1 week course of amoxicillin
15900328|NCT03647150|Dietary Supplement|Ready-to-use therapeutic food (RUTF)|1 sachet RUTF per day (508 calories) till child MUAC is greater than 12.4 cm or 12 weeks have elapsed
15920169|NCT03496701|Device|control lens|contact lens
15900330|NCT03647137|Other|Detailed motor testing, including FoG, in PD subjects|"Subjects with PD with and without freezing of gait (FoG) will undergo a biomechanical assessment during a FoG provocation protocol in both the dopaminergic on and off state."
15900331|NCT03647124|Drug|Lenalidomide|Lenalidomide
15900332|NCT03647111|Drug|Crizotinib|Crizotinib 250mg po bid
15900333|NCT03647098|Genetic|kras|the gene mutation
15900334|NCT03647085|Device|Wearable cardiac monitor|Participants will be fitted with a wearable cardiac monitor placed on the skin that measures physiologic signals.
15900335|NCT03647072|Drug|CHOP|CHOP only
15900336|NCT03647072|Drug|CHOP Plus Lanzoprazole|CHOP plus Lanzoprazole 60 mg
15900337|NCT03647072|Drug|CHOP Plus Famotidine|CHOP Plus Famotidine 40 mg
15900338|NCT03647059|Diagnostic Test|LSCM examination|Cut a piece of donor liver and conduct the LSCM examination after staining fluorescein
15900339|NCT03647046|Device|Customized Scleral Lens|A wavefront customized scleral lens will be made for each subject and tested against a non-customized lens.
15900340|NCT03647033|Device|iStent implantation|The iStent is a FDA and Health Sciences Authority (HSA) approved micro-bypass stent device that bypasses the trabecular meshwork (filtration membrane of the aqueous fluid exit pathway) and reroutes aqueous from the anterior chamber directly into canal of Schlemm and out of the eye. It lowers the intraocular pressure (IOP) by increasing the outflow of fluid from the eye from the micro-bypass. In angle closure, the lens has to be removed to create enough space for the iStent to be inserted.
15900341|NCT03647007|Other|FIFA 11 for health|The training consists of various football exercises, such as passing, shooting, dribbling, etc., and small-sided games. The small-sided games are performed as e.g. 3v3 with small goals (2x5 m).
15900342|NCT03646994|Drug|Crizotinib|Crizotinib Cap 250 mg po bid
15900343|NCT03646981|Device|Leishmania Ab Rapid Test (CTK, Biotech)|Rapid diagnostic tests to detect antibodies anti-Leishmania
15900344|NCT03646968|Drug|Anlotinib and Docetaxel|Patients who was Progress after First line Standard Cheomotherapy in advanced non-driver mutation non- squamous non-small cell lung cancer recieved the treatment of Anlotinib and Docetaxel (Anlotinib, 12mg, po,qd and Docetaxel 175mg/m2, ivgtt, every 21day)
15900345|NCT03646955|Radiation|No partial breast irradiation|Omission of radiation therapy
15900346|NCT03646942|Radiation|low level laser therapy|low level laser therapy will be used in order to induce tooth movement. low level laser with a wave length of 830 nm, output of 150 mw, energy of 2 j per point and application time of 15 seconds per point will be applied on each tooth of the six upper incisors according to this protocol: the root will be divided into 2 halves; gingival and cervical. Laser will be applied in the center of each half from both the buccal and palatal sides which means 4 application points and a total energy of 8 Joules/each tooth.
15900347|NCT03646942|Device|Lingual Orthodontics|Lingual braces will be used to conduct the orthodontic treatment of patients with moderate level of crowding on the upper dental arch.
15900348|NCT03646929|Diagnostic Test|MEP using standard facilitation technique|measuring of MEP using standard facilitation technique according to the Guidelines of International Federation of Clinical Neurophysiology
15900349|NCT03646929|Diagnostic Test|MEP using modified facilitation technique|measuring of MEP using modified facilitation technique (application of additional 8-12x magnetic stimuli for arms and legs)
15900350|NCT03646916|Drug|Dexamethasone|Gluco-corticosteroid
15900351|NCT03646916|Other|No dexamethasone|Nothing
15900352|NCT03646903|Behavioral|Cognitive Bias Modification|Cognitive bias modification (CBM) interventions typically involve the completion of brief, web-based tasks in which individuals are presented with a series of stimuli (e.g., words, sentences) and trained to respond in a manner that is positive or neutral, rather than negative and unhelpful. CBM interventions rely on the premise that repeated reinforcement of adaptive cognitions and a reshaping of negative cognitions enhance functioning and reduce distress.
15900353|NCT03646903|Behavioral|Psychoeducation|Psychoeducation-based interventions rely on the premise that enhancing knowledge about psychiatric symptoms and treatment will facilitate treatment engagement.
15900354|NCT03646877|Drug|Ozone|Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing Ozone (O3).
15900355|NCT03646877|Other|Filtered Air|Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing filtered air.
15900356|NCT03646864|Drug|ACT-541468|ACT-541468 will be orally administered as a tablet (50 mg strength) at a once daily (o.d.) dose of 50 mg in the evening.
15900357|NCT03646864|Other|Placebo|Placebo will be orally administered as a tablet matching ACT-541468, o.d. in the evening.
15900358|NCT03646851|Diagnostic Test|Questionnaries|patients will have to do a sputum and to complete some questionnaries
15900359|NCT03646825|Dietary Supplement|Natural Antioxidant supplement|1 capsule orally three times a day for 12 weeks
15900360|NCT03646812|Other|Glucose Reference 1|Glucose contains 50g of available carbohydrates
15900361|NCT03646812|Other|Glucose Reference 2|Glucose contains 50g of available carbohydrates
15900362|NCT03646812|Other|Glucose Reference 3|Glucose contains 50g of available carbohydrates
15900363|NCT03646812|Other|Semolina Penne|Semolina Penne contains 50g of available carbohydrates
15900364|NCT03646812|Other|Wholegrain Penne|Wholegrain Penne contains 50g of available carbohydrates
15900365|NCT03646812|Other|Semolina Spaghetti|Semolina Spaghetti contains 50g of available carbohydrates
15900366|NCT03646812|Other|Wholegrain Spaghetti|Wholegrain Spaghetti contains 50g of available carbohydrates
15900367|NCT03646812|Other|Jasmine Rice|Jasmine Rice contains 50g of available carbohydrates
15900368|NCT03646812|Other|Asian Noodles|Asian Noodles contains 50g of available carbohydrates
15900369|NCT03646799|Drug|CKD-387|test drug
15900370|NCT03646799|Drug|D484|reference drug
15900371|NCT03646786|Device|Virtual reality tests|"The patient will complete 3 self-questionnaires and pass 3 exploratory tests of virtual reality:
~10 minutes sitting test: detection of 5 targets in a 360 ° field of vision
~10-minute stand-up motionless test: detection of 5 targets in a 360 ° field of view and placing ingredients of a recipe
~Standing 10-minute test: the patient moves to the site of his mission, detection of 5 targets in a 360 ° field of vision and preparing a recipe"
15900878|NCT03642938|Behavioral|Control|The Control group will perform 30 minutes of quiet rest.
15900372|NCT03646760|Behavioral|HYCR|"This group involves a hybrid design, with the frequency of center based cardiac rehabilitation (CBCR) visits and HYCR visits individualized and modified based on the subject's personal preferences and their family, transportation and work constraints. Patients in HYCR will engage in at least one CBCR visit. Patients will have the video app loaded to their smart phone or tablet (or that of a willing to assist family member or friend). HYCR patients receive a chest strap/wrist heart rate device to document HR before, during, and/or after exercise during the TM session. Program education for patients in HYCR will be delivered using the twenty-eight, 7-15 min audio PDF's that are free to access from the Health System's web site."
15900373|NCT03646760|Behavioral|CBCR|This group will attend 2-3 sessions of cardiac rehabilitation per week at the investigator's Detroit location. Program education for patients in CBCR will be delivered during eight. 1 hour education lectures taught by staff (exercise physiologists and registered dieticians).
15900374|NCT03646747|Diagnostic Test|MRI scan|Additional imaging using MRI scan
15900375|NCT03646721|Drug|DA-1241|"[Part1] Administration once daily for 28 days; Dose strength for each cohort (Cohort 1, 2 and 3) is planned as 50mg, 100mg and 200mg, respectively.
~[Part2] Administration once daily for 56 days; Dose strength for each cohort (Cohort 4, 5 and 6) is planned as 25mg, 50mg and 100mg, respectively.
~(Dose escalation and dose level decisions for subsequent cohorts will be made via interim dose escalation review meetings.)"
15900376|NCT03646721|Drug|Placebo|[Part1] Administration once daily for 28 days. [Part2] Administration once daily for 56 days.
15900377|NCT03646721|Drug|Sitagliptin|[Part2] Administration of Sitagliptin 100mg once daily for 56 days.
15900378|NCT03646695|Procedure|ILM flap transposition|during ILM flap Transposition, an ILM flap is placed on the macular hole
15900379|NCT03646695|Procedure|ILM peeling|during ILM Peeling the ILM is removed around the macular hole
15900380|NCT03646682|Procedure|vitrectomy with membrane peeling|during vitrectomy with membrane peeling a prob of the vitreous body and the excised epiretinal membrane will be harvested for gas-chromatography/mass spectrometry
15900381|NCT03646669|Behavioral|PEF Feedback|Patients in the PEF feedback arm will receive a one-time session including asthma management education, discussion of their asthma symptoms, review of individual PEF results and perception of symptoms, and problem-solving techniques to improve asthma self-management. After the session, the participants in this arm will be able to view in the display of the AM2 device their PEF values and will be instructed to mentally note their actual results with their pre-effort estimated BPF. They will also set a motivational message for themselves that will appear on the device.
15900382|NCT03646669|Behavioral|Asthma education|General asthma education, AM2 training, and positive counseling, but no discussion linking asthma symptom perception to SMB. Following the session, these participants will use the AM2 to track PEF actual and perceived values twice per day, but they will be blinded to the actual PEF values. Control arm patients will see a standard motivational message appear on the screen of the AM2 device.
15900383|NCT03646656|Behavioral|reciprocal peer support and non reciprocal coach support|Peers and peer coaches provide mutual or one-way support to initiate and sustain behavioral improvements for cardiovascular health, with additional education from study staff.
15900384|NCT03646643|Procedure|Standard Atrial fibrillation ablation|The AF ablation procedures should follow the sequence below: Diagnostic catheter placement Electrophysiology study; Transseptal puncture; Left atrial electro-anatomical mapping is required prior to an ablation procedure. Post ablation pacing procedure(s) and/or infusion of cardiac medications to localize triggers/ assess and localize pulmonary vein reconnections (e.g., Adenosine, Isoproterenol 2-20 mcg/min). Study procedure requirements are outlined below: Isolation of all pulmonary veins and Non-pulmonary vein trigger ablation for all patients. Linear ablation lines are only required to treat documented macro-reentry atrial tachycardias and limited to the following targets only: LA roof line, mitral valve isthmus line, LA floor line, right atrial carvotricuspid isthmus linear ablation.
15900385|NCT03646643|Procedure|Coronary sinus to left atrium connection elimination|Distal coronary sinus pacing will be utilized to localize distal connections between the main coronary sinus body and the left atrium. Focal lesions will be applied to early left atrial activation sites, until no distal coronary sinus to left atrial connections are electrically manifest. If vein of marshall connections to the left atrium are present, differential pacing will be utilized to prove the lack of distal coronary sinus to left atrium connections.
15900386|NCT03646630|Procedure|Quadratus Lumborum Block|Posterior or QL block type 2 , a bolus of 0.5 ml/Kg bupivacaine 0.25%
15900387|NCT03646630|Procedure|Caudal Block|caudal block with 1 ml/kg of bupivacaine 0.25%.
15900388|NCT03646617|Radiation|Hypofractionated Radiation Therapy (HFRT)|The dose of HFRT will be 8 Gy x 3 fractions, given over a maximum of 7 days timespan.
15900389|NCT03646617|Drug|Nivolumab|Nivolumab (1 mg/kg) will be administered as an IV infusion over 30 minutes, followed by ipilimumab (3 mg/kg) on the same day given as an IV infusion over 90 minutes. The two drugs will be given on day 1, then every 3 weeks for a total of four doses. After these 4 doses, the patient and investigator will decide to continue with nivolumab (240 mg) every 2 weeks or Nivolumab (480mg) every 4 weeks as monotherapy for up to one year as an IV infusion over 30 minutes.
15900390|NCT03646617|Drug|Ipilimumab|Nivolumab (1 mg/kg) will be administered as an IV infusion over 30 minutes, followed by ipilimumab (3 mg/kg) on the same day given as an IV infusion over 90 minutes. The two drugs will be given on day 1, then every 3 weeks for a total of four doses.
15900391|NCT03646604|Drug|Upadacitinib (ABT-494)|Upadacitinib will be administered orally.
15900392|NCT03646591|Drug|Chemotherapy|Patients will receive four cycles of the standard dose of FLOT chemotherapy prior to curative gastrectomy. And four cycles of the FLOT chemotherapy is recommended after surgery. Preventive antiemetic and dexamethasone are allowed before chemotherapy, growth factor, or other supportive medicines are allowed for treatment only. Surgical intervention is allowed for acute bleeding or other surgical emergencies.
15900393|NCT03646578|Other|State of anxiety|"Patient anxiety assessment by STAI-Y-A self-assessment questionnaire provided before and after pediatric interview.
~The assessment is given to patients upon arrival in the hospitalization service of pregnancies and again after the pediatric interview. This pediatric interview should take place between 1 and 7 days after admission to the hospital ward.The second part includes a 6-week inclusion period with assessment of patients' state of anxiety by a STAI-Y-A self-assessment questionnaire given before and after pediatric interview associated with the delivery of a written document. on prematurity."
15920170|NCT03496688|Procedure|Sinus floor augmentation|
15900394|NCT03646552|Drug|THX-110|"Participants will receive THX-110 in the following regimen:
~Dronabinol will be slowly titrated in the first 10 days of the study and PEA will be given in a constant dose of 800mg per day for the entire duration of the study.
~Patients will be followed for a total of 30 days."
15900395|NCT03646539|Behavioral|Use of smartphone application (app)|Use of a CBT-based automated conversational agent available as a mobile device smartphone application for the management of mood.
15900396|NCT03646539|Other|Treatment as usual|Treatment as usual will include (but may not be limited to) the participant's 6-week postpartum follow-up visit with their obstetrics care team. Participants will be sent surveys to evaluate their depressive and anxiety symptoms.
15900397|NCT03646526|Drug|Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting）|Amitriptyline Hydrochloride 25Mg Tablet（Hunan Dongting）is a generic product manufactured by Hunan Dongting Pharmaceutical Co., Ltd.
15900398|NCT03646526|Drug|Amitriptyline Hydrochloride 25Mg Tablet（Sandoz）|Amitriptyline Hydrochloride 25Mg Tablet（Sandoz）is a generic product manufactured by Sandoz Inc;
15900399|NCT03646513|Device|SMF Short Modular Femoral Hip System|Primary Total Hip Arthroplasty with SMF Short Modular Femoral Stem Hip System.
15900400|NCT03646500|Procedure|Retrobulbar Block|Anesthetic nerve block administered in the retrobulbar space prior to transcleral diode procedure
15900401|NCT03646500|Procedure|Remifentanil|Remifentanil administered as intravenous infusion prior to transcleral diode procedure
15900402|NCT03646487|Dietary Supplement|Probiotic LP299v 10x10 colony forming units in capsule form|Daily lactobacillus plantarum (LP299v) 10x10 colony forming units in capsule form
15900403|NCT03646487|Other|Placebo in capsule form|Daily placebo in capsule form
15900404|NCT03646474|Drug|tranexamic Acid infusion|The tranexamic Acid group will receive an intravenous bolus of (10 mg/kg) in 100 ml of normal saline over 20 minutes after induction of anesthesia and before surgical incision.
15900405|NCT03646474|Drug|saline infusion|In the placebogroup, patients will receive a placebo of 100 mL 0.9% normal saline.
15900406|NCT03646461|Drug|Ibrutinib 560mg PO daily (Imbruvica)|BTK inhibitor combined with PD-1 inhibitor
15900407|NCT03646461|Drug|Cetuximab|Cetuximab 400mg/m2 x 1 then 250 mg/m2 weekly 28 day cycle
15900408|NCT03646461|Drug|Nivolumab|Nivolumab 3mg/kg biweekly 28 day cycle
15900410|NCT03646435|Device|Fitbit Charge 2|The Fitbit Charge 2 is the electronic wearable chosen for this pilot study. This particular Fitbit is capable of measuring patient heart rate, sleep and physical activity. The data collected will then be analyzed with respect to the outcomes of this study. To determine the accuracy of the Fitbit, data collected will be compared to the nurses' standard patient assessment (for HR and physical activity) and to patient responses on the Richards-Campbell Sleep Questionnaire (for sleep).
15900411|NCT03646422|Other|Registry of patients (exposure is Cutaneous Lymphoma)|
15900412|NCT03646409|Other|Venous thromboembolic event, arterial thromboembolic event, bleeding events|Whether or not venous or arterial thromboembolic and bleeding events occur in patients with esophageal cancer receiving neoadjuvant chemotherapy
15900413|NCT03646396|Drug|Sofosbuvir-daclatasvir|Sofosbuvir-daclatasvir for 3 months
15900415|NCT03646370|Drug|Tenofovir Alafenamide|Patients with HIV infection who are virally suppressed receiving a tenofovir disoproxil fumarate-based antiretroviral therapy regimen that switched to tenofovir alafenamide without switching any other components of their treatment regimen.
15900416|NCT03646357|Other|Non-betablocker|No betablocker will be administered. Patients randomized to no beta-blockade will be discouraged to use beta-blockade as long as there is no other indication than strictly secondary prevention after myocardial infarction. Any other treatment or management is to be given as per usual care.
15900417|NCT03646357|Drug|Betablocker|"A betablocker will be administered. To reflect contemporary management, for which this study is designed to test, there will not be a defined minimum dosage. The type and dose of BB will be left at the discretion of the PI. Generic drug and accepted dosages will be:
~Metoprolol succinate up to a total dose of 200mg daily
~Bisoprolol up to a total dose of 10mg daily
~Carvedilol up to a total dose of 50mg daily
~The treating physician will be encouraged to aim for an equipotent dose of 100 mg metoprolol succinate or higher. Any other treatment or management is to be given as per usual care."
15900418|NCT03646344|Drug|Heme Arginate 25 MG/ML|IMP - to be administered at a dose of 3mg/kg to a maximum dose of 250mg over 30 mins. Participants will receive intervention twice during the trial, one on Day 0 (day of transplantation) and then again on D1 (20-28 hours after dose 1).
15900419|NCT03646344|Drug|0.9% Sodium-chloride|Placebo - 100ml of 0.9% Sodium Chloride will be given over 30 mins. Participants will receive intervention twice during the trial, one on Day 0 (day of transplantation) and then again on D1 (20-28 hours after dose 1).
15900420|NCT03646331|Drug|Imeglimin Reference product|Reference product
15900421|NCT03646331|Drug|Imeglimin|Test product (new formulation tablet)
15900422|NCT03646318|Drug|Ketanserin|"The dose of 0.75 ug/kg/min is a dose that has been used frequently in critically ill patients. The concentration of the study drug infusion will be 40 mg/40 ml glucose 5%. The maximum dose however will be 4.5 mg per hour for patients with a weight more than 100 kg. The pre-filled 50 ml syringes will be filled with 40 ml of a solution containing 40 mg ketanserin or 0 mg ketanserin in glucose 5%.
~The minimum number of ketanserin vials (2 ml with 5 mg/ml) that are needed is 240 (40 mg = 4 vials per patient). Duration of intervention: 8 hours"
15900423|NCT03646318|Other|Placebo|Glucose 5% solution
15900424|NCT03646305|Behavioral|Cognitive Defusion|Cognitive defusion aims to change one's relationship to their thoughts - as opposed to changing the content, form, or frequency - by reframing internal experiences as less threatening (Hayes, Luoma, Bond, Masuda, & Lillis, 2006). It is the process of detaching the link between one's thoughts and perceptions of reality and acknowledging the role one's thoughts play in their internal events. A number of techniques have been developed to remove the literal quality of such thoughts, including repeating the thought, and, more recently, singing the thought.
15900921|NCT03642561|Device|radiotherapy ablation|We using Cool Tip system or RITA system to perform RFA
15900425|NCT03646292|Drug|Pioglitazone|The investigators will compare the degree of liver fat between Pioglitazone monotherapy, Empagliflozin monotherapy, Combination of pioglitazone and empagliflozin following randomization.
15900426|NCT03646292|Drug|Empagliflozin|The investigators will compare the degree of liver fat between Pioglitazone monotherapy, Empagliflozin monotherapy, Combination of pioglitazone and empagliflozin following randomization.
15900427|NCT03646292|Drug|Combination of pioglitazone and empagliflozin|The investigators will compare the degree of liver fat between Pioglitazone monotherapy, Empagliflozin monotherapy, Combination of pioglitazone and empagliflozin following randomization.
15900428|NCT03646279|Device|Calibrace|The CALIBRACE is a new product designed to improve posture using a front-to-back tensioning system that lifts shoulders up and back.
15900429|NCT03646266|Drug|Rocuronium Bromide|Titration with rocuronium bromide until tidal volume 6ml/kg PBW
15900430|NCT03646253|Other|Analysis of radiology (standard radiographies, 2D scan sections and 3D reconstructions)|
15900431|NCT03646240|Drug|ABI-009|For dose finding, ABI-009 will start at 5 mg/m2/dose IV, once a week for three weeks, in cohorts of 3 participants each using the standard 3+3 dose-finding design
15900432|NCT03646227|Other|Standard of Care|There is no prescribed intervention for this study. Standard of care will be captured in the eCRF.
15900433|NCT03646214|Device|Midline traction oral appliance|Device positions the mandible forward to open airway; device can be titrated to gradually advance the mandible.
15900434|NCT03646201|Behavioral|FFF|FFF teaches authoritative parenting skills for reducing children's exposure to and intakes of SoFAS, including changes to the family eating environment, mothers' own eating behaviors, and food parenting practices.
15900435|NCT03646188|Drug|Placebo-containing MNA|A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering a placebo.
15900436|NCT03646188|Drug|25 µg doxorubicin-containing MNA|A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 25 µg of doxorubicin hydrochloride.
15900437|NCT03646188|Drug|50 µg doxorubicin-containing MNA|A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 50 µg of doxorubicin hydrochloride.
15900438|NCT03646188|Drug|100 µg doxorubicin-containing MNA|A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 100 µg of doxorubicin hydrochloride.
15900439|NCT03646188|Drug|200 µg doxorubicin-containing MNA|A 15 x 15 mm array containing 400 tip-loaded, dissolvable microneedles delivering 200 µg of doxorubicin hydrochloride.
15900440|NCT03646175|Dietary Supplement|Choline|Participants will consume 1000 mg (2x500 mg) of choline bitartrate (over-the-counter supplement) between 10PM and 12AM the evening before the scheduled testing session and arrive fasted to the laboratory. There will be 2 testing sessions separated by 1 week.
15900441|NCT03646175|Dietary Supplement|Placebo|Participants will consume 1000 mg (2x500 mg) of placebo between 10PM and 12AM the evening before the scheduled testing session and arrive fasted to the laboratory. There will be 2 testing sessions separated by 1 week.
15900444|NCT03646136|Procedure|Retained fluid|Retained fluid
15900445|NCT03646136|Procedure|Emptied fluid|Emptied fluid
15900452|NCT03646110|Procedure|Minimally invasive esophagectomy|Minimally invasive esophagectomy is a surgical procedure for esophageal resection
15900453|NCT03646097|Procedure|Angio-PCI|PCI only with angiography and without OCT findings
15900454|NCT03646097|Procedure|OCT-PCI|PCI with OCT-measurements but no transfer of landingzone-markers to angiography
15900455|NCT03646097|Procedure|ACR-PCI|PCI with OCT-measurements and transfer of landingzone-markers to angiography
15900456|NCT03646084|Other|Sleep and Circadian Intervention Program (SCIP) plus rehabilitation program|To study circadian rhythm disorders and sleep disorders and develops the SCIP to improve sleep in the patients.
15900457|NCT03646084|Other|Rehabilitation program|Rehabilitation program current clinical practice
15900458|NCT03646071|Drug|RX108|RX108
15900459|NCT03646058|Drug|Buprenorphine|Buprenorphine, 0.4mg pills, sublingual
15900460|NCT03646058|Drug|Placebo|Placebo pills, sublingual, specifically made to mimick buprenorphine pills
15900461|NCT03646045|Other|Transpyloric feeding|Preterm infant feeding using transpyloric feeding tube (nasoduodenal tube)
15900462|NCT03646032|Behavioral|SAAFE|After completing the pre-game assessment, participants will be asked to play the SAAFE game for at least 30 minutes and up to 1 hour . At the conclusion of the game, participants will be provided with a post-game assessment about their perception of risk, knowledge of specific protective behaviors, and whether they plan to change behaviors.
15900463|NCT03646032|Behavioral|Control|This group will receive dating sim game (called Choices). They will also receive pamphlets that provide information on the testing location and care if they have HIV/STI.
15900464|NCT03646006|Drug|Bupivacaine|10 mL (5mg/mL)
15900465|NCT03646006|Drug|Placebo|10 mL normal saline
15900466|NCT03645993|Genetic|Genetic Testing|A one time blood sample will be taken.
15900467|NCT03645980|Drug|DKN-01 300 mg|DKN-01 will be administered intravenous (IV) over a minimum of 30 minutes and up to a maximum of 2 hours given on days 1 and 15 of each 28 day cycle.
15900468|NCT03645980|Drug|DKN-01 600 mg|DKN-01 will be administered intravenous (IV) over a minimum of 30 minutes and up to a maximum of 2 hours given on days 1 and 15 of each 28 day cycle.
15900469|NCT03645980|Drug|Sorafenib|For combination with DKN-01, sorafenib will be administrated according to standard clinical practice. Part A: After 8 weeks monotherapy with DKN-01, the study will be continued as combination therapy of DKN-01 and sorafenib until objective disease progression (PD) or unacceptable toxicity occurs. Part B:After PD1, study treatment will be continued as combination therapy of DKN-01 and sorafenib until disease progression (PD2) or unacceptable toxicity occurs.
15900470|NCT03645967|Device|ReadyCleanse Cloths|ReadyCleanse cloths and the standardized cleansing procedure will be the standard-of-care for catheter care and maintenance; patients will undergo routine perineal care for a minimum of twice per day and after each incontinent episode.
15900471|NCT03645954|Procedure|Femoral Nerve Block|"Procedure: Femoral Nerve Block
~The femoral nerve block will be performed as described in Arms section.
~Device: Ultrasound
~Linear ultrasound transducer probe (Flex Focus 400 exp, bk medical, Denmark) will be used to guide the needle placement.
~Device: Needle
~20-gauge 50 mm Ultraplex needle (B. Braun Medical Inc., Melsungen, Germany) will be used to perform the femoral nerve block.
~Drug: Local anesthetic
~Bupivacaine 0.125% 20 mL will be used to perform the femoral nerve block."
15900472|NCT03645954|Procedure|Femoral Triangle & Adductor Canal Blocks|"Procedure: Femoral Triangle & Adductor Canal Blocks
~These two blocks will be performed as described in Arms section.
~Device: Ultrasound
~Linear ultrasound transducer probe (Flex Focus 400 exp, bk medical, Denmark) will be used to guide the needle placement.
~Device: Needle
~20-gauge 100 mm Ultraplex needle (B. Braun Medical Inc., Melsungen, Germany) will be used to perform the femoral triangle block and adductor canal block.
~Drug: Local anesthetic
~Bupivacaine 0.125% 20 mL will be used to perform the femoral triangle block and adductor canal block (10 mL for each block)."
15900473|NCT03645941|Behavioral|Facebook Group|The pilot trial, a two-arm, parallel groups, randomized controlled design, will enroll 60 participants randomized with 1:1 allocation to the intervention or control condition. Participants will be randomized within stratified blocks based on sex (male, female), age group (19-29, 30-49, 50+ years), and region (urban, rural); potential variables related to outcomes. Assessments will be conducted for both study groups at baseline and at 1, 3, and 6 month follow-up.
15900480|NCT03645915|Other|Immunohistochemistry|Immunohistochemistry of Glut1 expression was performed in these 36 cases of neuroendocrine tumor.
15900481|NCT03645902|Diagnostic Test|Magnetic resonance imaging|
15900482|NCT03645889|Other|PLTG|A combination of 13 herbal granules
15900483|NCT03645889|Other|Placebo|90% starch filler and 10% PLTG
15900484|NCT03645876|Drug|SHR-1210|200mg
15900485|NCT03645876|Drug|BP102|7.5mg/kg
15900486|NCT03645876|Drug|oxaliplatin|130mg/m2
15900487|NCT03645876|Drug|capecitabine|1000mg/m2
15900488|NCT03645863|Drug|MT-6548|Oral tablet
15900489|NCT03645863|Drug|Iron supplement A|Oral tablet
15900490|NCT03645863|Drug|Iron supplement B|Oral tablet
15900491|NCT03645863|Drug|Iron supplement C|Oral tablet
15900492|NCT03645863|Drug|Iron supplement D|Oral tablet
15900493|NCT03645850|Device|Vismed gel Multi 0.3% eye drops|Ophthalmic use. Vismed gel Multi 0.3% eye drops. One to two drops instilled in each eye from 4 to 6 times per day during 84 days of treatment.
15900494|NCT03645850|Device|Vismed Multi 0.18% eye drops|Ophthalmic use. One to two drops instilled in each eye from 4 to 6 times per day during 84 days of treatment.
15900495|NCT03645837|Other|Compression clamp release|Standard compression clamp is used and will be released at different times according to randomization
15900496|NCT03645824|Drug|Pacritinib|Patients receive up to 4 cycles of pacritinib before allo-SCT
15900497|NCT03645811|Behavioral|Music Therapy|Music therapy was applied in the application room. Via a portable computer, students listened to the mahur maqam for 20 minutes under the supervision of the investigators using an MP3 player.
15900498|NCT03645811|Behavioral|EFT|EFT includes taps, nine gamut sequences, and eye movements on the meridian system, focusing on the individual's inhibiting thoughts, disturbing emotions, or memories. EFT regulates the flow of energy in the meridian system of the individual, causing relaxation in the mind, body, and emotions.
15900499|NCT03645798|Behavioral|"Three good things therapy"|"To maintain an emphasis on the positive experience, participants were directed to record three good things that went well each day. These things could be minor, ordinary, or important. Next to each good thing, participants were required to answer the question: Why did this good thing happen?"
15900500|NCT03645798|Behavioral|Normal psychological instruction|Normal psychological instruction is a convenient method set by the hospital. Nurses who have stress or psychological problem could find help through this intervention. It was delivered by psychologists.
15900501|NCT03645785|Dietary Supplement|Normal fluid intake without true lemon|16.9oz water with True Lemon
15900502|NCT03645785|Dietary Supplement|Double fluid intake plus 3 bottles of water with True Lemon|No intervention
15900503|NCT03645772|Other|Exercise intervention|12-week progressive training intervention
15900504|NCT03645759|Behavioral|I'm Whole|I'm whole will provide 6 behavioral health treatment sessions that focus on stroke self-management, psychological distress and social re-integration.
15900505|NCT03645759|Other|Education + usual care|Will receive the standard usual care for stroke self-management provided by the Michael E. Debakey VA Medical facility and will receive 6 brief health education calls unrelated to stroke or psychological distress.
15900506|NCT03645746|Drug|REGN5069|REGN5069 will be administered by IV infusion or SC injection
15900508|NCT03645733|Procedure|Lower Temperature Group|Dialysate temperature of 35 degree centigrade. The intervention group will start off using a dialysate temperature that is 36 °C. Thereafter the dialysate temperature will be reduced every two week by 0.5 °C until 35 °C or the lowest tolerated temperature reached.
15900509|NCT03645720|Device|Plastic cannula|puncture using plastic cannula
15900510|NCT03645707|Behavioral|CAR Training and Psychoeducational Sessions|"Participation in the CAR Training Program, a 1-day training program developed by the J&J Human Performance Institute (HPI). The CAR Training Program uses a holistic approach that focuses on moving between stress and strategic recovery to help build resilience and enable higher performance.
~Participants will attend eight weekly follow-up psychoeducational group sessions facilitated by a licensed mental health counselor that will meet for 90 minutes. The themes of these sessions will be RISE - Resilience, Insight, Self-Compassion, and Empowerment. Due to limited time and flexibility in sessions, participants will practice skills through optional homework activities to facilitate learning between sessions."
15900511|NCT03645694|Device|Social Support Aid|Please see earlier; the social support aid technology consists of a smartphone with a facial recognition software application and a smartwatch. Up to 1,000 individuals can be enrolled in the facial recognition application. Enrollment includes typing individuals names and relationships of the person with memory concern into the application and taking pictures of PWMC's faces at multiple angles. Once enrolled and in view of the smartphone's camera, the SSA's application recognizes the individual's face and alerts the smartwatch. The watch then vibrates and displays the individuals' name and relationship to the PWMC.
15900512|NCT03645681|Device|InnAVasc arteriovenous graft surgical implant|An InnAVasc AVG will be surgically implanted into the upper arm or forearm of enrolled participants
15900513|NCT03645668|Drug|Meropenem Injection|Different administration types between two groups
15900514|NCT03645655|Diagnostic Test|PIVKA-II|Serum samples are tested for tumor markers including PIVKA-II, AFP, and biochemical tests.
15900515|NCT03645642|Drug|Midodrine|Midodrine 5 mg thrice daily
15900516|NCT03645642|Biological|Albumin|Albumin 20g/l
15900517|NCT03645642|Drug|Diuretics|Diuretics will be continued with an maximum dose of furosemide (160mg) and Aldactone 400 mg.
15900518|NCT03645629|Diagnostic Test|skin test with food at different storage times|Perform skin tests to each foods at 0, 3, 6 months after preparation and compare the results
15900519|NCT03645616|Diagnostic Test|6-minute walk test|"First day: Participants undertook 6-minute walk test. There was a 30-minute interval between the first and second test, when the patient was asked to rest. During the resting period, they respond a pain intensity, functional capacity and physical activity level questionnaire.
~Second day: the participants repeated the test and questionnaires."
15900520|NCT03645616|Diagnostic Test|10 meters walk test|"First day: After the second 6-minute walk test the participants perform the 10-meter walk test, the test must be performed three times with a 30-second interval, at the end the average test velocity.
~Second day: the participants repeated the test."
15900521|NCT03645616|Diagnostic Test|30 Second Sit to Stand Test|At the end of the tests the participants perform the 30 Second Sit to Stand Test on the first and second day.
15900522|NCT03645603|Drug|Dexmedetomidine|intravenous infusion
15900523|NCT03645603|Drug|Placebo|intravenous infusion of physiological saline solution to mimic dexmedetomidine infusion
15900524|NCT03645590|Behavioral|Stroke Ready|Stroke Ready community intervention consists of peer facilitated educational workshops, stroke music video, and mass media campaign including print materials (e.g. posters, brochure), health promotion mailers, radio/Television public health service announcements, and the Stroke Ready website and Facebook page.
15900525|NCT03645564|Other|Specialized nurse consultation|The purpose of this consultation is to establish a partnership between the patient and the nursing staff. Tools were set up (notebook, movie) to answer the questions of the patient. In case of specific question, an expert will meet the patient (doctor of the service, psychologist, pharmacist or hematologist).
15900526|NCT03645551|Diagnostic Test|checkup, no test|In this study we would like to examine if existing restorations already applied in teeth which we treated with laminate veneers had an effect. We will evaluate the laminate veneers by sight and take pictures and use a questionnaire
15900527|NCT03645538|Other|Parkinson's disease patients|"The neurophysiological evaluation will be conducted during ON (with medication) and OFF (without medication) period, by transcranial magnetic stimulation by single pulse (EMT-p) and by EEG."
15900528|NCT03645538|Other|No drug|The neurophysiological evaluation in healthy subjects will be conducted by transcranial magnetic stimulation by single pulse (EMT-p) and by EEG.
15900529|NCT03645525|Drug|Human Umbilical Cord-derived Mesenchymal stem cell|The Human Umbilical Cord-derived Mesenchymal stem cells suspension (2×10^7/kg per KG of the infant 's weight ) will be instilled once through a catheter into the infant' s endotracheal tube
15900530|NCT03645525|Drug|placebo|saline
15900531|NCT03645512|Behavioral|Corporate Athlete Resilience (CAR) Training Program|A 1-day training program developed by the J&J Human Performance Institute (HPI), which uses a holistic approach that focuses on moving between stress and strategic recovery to help build resilience and enable higher performance.
15900532|NCT03645499|Drug|Topical TA-102 A|applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks
15900533|NCT03645499|Drug|Topical TA-102 B|applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks
15900534|NCT03645499|Drug|Topical TA-102 C|applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks
15900535|NCT03645499|Drug|Topical TA-102 D|applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks
15900536|NCT03645499|Drug|Topical TA-102 E|applied smoothly and evenly to affected areas (excluding face, axilla and groin areas) once daily for 12 weeks
15900537|NCT03645486|Genetic|Infusion of lentiviral TYF-CGD-modified autologous stem cells|Infusion of lentiviral TYF-modified autologous stem cells at 1~10x10^6 gene-modified cells per kg body weight
15900538|NCT03645473|Device|Monarch Airway Clearance System|HFCWO Airway Clearance Device
15900539|NCT03645460|Genetic|TYF-ADA gene-modified autologous stem cells|Infusion of TYF-ADA-modified autologous stem cells at 1~10x10^6 gene-modified cells per kg body weight; or more infusions depending on the circumstances
15900540|NCT03645447|Diagnostic Test|Taste test|A device is used to present a pseudo-randomised series of taste solutions to the participant for identification, in order to establish taste thresholds.
15900541|NCT03645434|Drug|AZD8871|Randomized patients will receive 14 repeated daily doses of AZD8871 600 µg inhalation powder via DPI.
15900542|NCT03645434|Drug|Anoro® Ellipta®|Randomized patients will receive 14 repeated daily doses of Anoro® Ellipta® (55 µg/22 µg) inhalation powder via DPI.
15900543|NCT03645421|Drug|MEDI0382 100 μg|Solution for injection in 1.0 mL pre-filled syringe, 100 μg per dose, 1 dose
15900544|NCT03645421|Drug|MEDI0382 200 μg|Solution for injection in 1.0 mL pre filled syringe 200 μg per dose, 1 dose
15900545|NCT03645421|Drug|MEDI0382 300 μg|Solution for injection in 1.0 mL pre filled syringe, 300 μg per dose, 1 dose
15900546|NCT03645421|Drug|PlaceboA|1.0 mL liquid formulation per Vial
15900547|NCT03645421|Drug|MEDI0382 50 ug|Solution for injection, 1.0 mL per vial, 50 ug
15900548|NCT03645421|Drug|PlaceboB|Solution for injection in 1.0 mL pre-filled syringe.
15900549|NCT03645408|Drug|Exenatide|5 mcg dose of immediate release exenatide
15900550|NCT03645408|Other|Sham injection|Subjects will have a sham injection with no study drug
15900551|NCT03645395|Drug|MT-3724|Experimental treatment with MT-3724 in combination with LEN therapy.
15900552|NCT03645382|Dietary Supplement|baked barley powder|The baked barley was consumed one capsules, three times daily before meals, for a total of three capsules consumed per day.The baked barley powder capsule had approximately 900 mg/day, 336 mg of baked barley and 564 mg of nondigestible maltodextrin.
15900553|NCT03645382|Dietary Supplement|jeju steam onion|The jeju steam onion was consumed one capsules, three times daily before meals, for a total of three capsules consumed per day.The jeju steam onion capsule had approximately 900 mg/day, 336 mg of jeju steam onion powder and 564 mg of nondigestible maltodextrin.
15900554|NCT03645369|Device|ShotBlocker|ShotBlocker is a drug-free tool with no side effects and does not require preparation. It is a flexible, plastic, C-shaped device with a number of short (2 mm) blunt contact points on its back.
15900555|NCT03645369|Device|Ice pack|Ice pack containing gel
15900556|NCT03645356|Device|Fixed Appliances|Using an MBT-prescription of metallic brackets, patients will be treated in the conventional way
15900557|NCT03645356|Device|Clear Aligners|Using a sequence of clear aligners, patients will be give an aligner every two weeks until the completion of treatment
15900558|NCT03645343|Device|Activator|This appliance is constructed in one piece to guide the position of the mandible on closure
15900559|NCT03645343|Device|Twin Block|This appliance is constructed in two pieces to guide the position of the mandible on closure
15900560|NCT03645317|Diagnostic Test|Blood tests & cardiac imaging|Blood tests (full blood count, lipids, cholesterol, high sensitivity Troponin levels, C-reactive protein (CRP) and brain natriuretic peptide) Cardiac imaging - cardiac CT, cardiac ultrasound, 12-lead ECG
15900561|NCT03645304|Drug|Ropivacaine|"Continuous wound infusion device used in this study was ON-Q Painbuster Silver Soaker (I-Flow Corporation, Lake Forest, CA, USA) comprised an elastomeric pump maintaining constant pressure to infuse 2ml/hour of analgesic to the wound through a catheter for 50 hours. In all participants, the surgeon inserted a 20-gauge, 6.5-cm, multi-holed soaker catheter through an introducer needle after closure of the transumbilical fascia. The catheter was located in the deep subcutaneous space, above the fascia near the skin incision. In the experimental group, an elastomeric pump filled with local analgesic solution (total volume 100ml) containing 750mg ropivacaine .
~Ropivacaine is local analgesics."
15900562|NCT03645304|Drug|0.9% saline group|Continuous wound infusion device used in this study was ON-Q Painbuster Silver Soaker (I-Flow Corporation, Lake Forest, CA, USA) comprised an elastomeric pump maintaining constant pressure to infuse 2ml/hour of analgesic to the wound through a catheter for 50 hours. In all participants, the surgeon inserted a 20-gauge, 6.5-cm, multi-holed soaker catheter through an introducer needle after closure of the transumbilical fascia. The catheter was located in the deep subcutaneous space, above the fascia near the skin incision. In the control group, an elastomeric pump filled with filled with 100ml of 0.9% saline .
15900563|NCT03645304|Device|ON-Q Painbuster Silver Soaker|ON-Q Painbuster Silver Soaker (I-Flow Corporation, Lake Forest, CA, USA)
15900564|NCT03645291|Diagnostic Test|Local insect allergen extracts skin test|Every patient received both local and commercial insect allergen extracts but in blinded methods
15900565|NCT03645278|Drug|SHR0532|Ascending dose oral adminstration
15900566|NCT03645278|Drug|Placebo|Ascending dose oral administration
15900567|NCT03645265|Behavioral|Auditory|Use of auditory cues to improve speech production
15900568|NCT03645265|Behavioral|Gestures|Use of gestures to improve speech production
15900569|NCT03645252|Procedure|Vein interruption before any other surgical manipulation|"The pulmonary tumor-drainage vein is first exposed and punctured with a 23-gauge needle, and 7.5 ml of blood is drawn from the pulmonary vein prior to subsequent surgical manipulation for lobectomy. Collected blood is versed in a Cellsearch tube provided by the manufacturer (Menarini Silicon Biosystems, Castel Maggiore, Italy).
~In the vein first group, the lobar vein is dissected and the cartridge and anvil of a vascular cartridge stapler are placed on either side of the vein. The vein is punctured above the stapler with a 23-gauge needle and 7.5 ml of blood is drawn. Finally, the vein is cut. The intervention then proceeds in the usual manner."
15900570|NCT03645252|Procedure|Arteries interruption before vein interruption|"The pulmonary tumor-drainage vein is first exposed and punctured with a 23-gauge needle, and 7.5 ml of blood is drawn from the pulmonary vein prior to subsequent surgical manipulation for lobectomy. Collected blood is versed in a Cellsearch tube provided by the manufacturer (Menarini Silicon Biosystems, Castel Maggiore, Italy).
~In the arteries before vein group, lobar arteries are first dissected and interrupted (+/- the bronchus and inter-lobar fissures). The lobar vein is then dissected and blood sample is performed as described above."
15900571|NCT03645239|Procedure|Mechanical Temporal Summation assessment|A 180 gram von Frey filament is applied on the subject's forearm. Patient will then be asked to rate the pinprick pain score on a verbal rating scale, 0-100. Following this, 10 consecutive touches at random locations are applied with a 1 second interstimulus interval and within a 1 cm diameter circle. The patient will then be asked to rate the 10th pain score (0-100). The Mechanical Temporal Summation Score is obtained by the difference between the 11th pain score and the 1st pain score. If the score is greater than zero, the patient is implied to have presence of Mechanical Temporal Summation.
15900572|NCT03645239|Other|Preoperative pain assessment|"Patients will be asked to rate, using a 0-10mm visual analog scale (VAS), their surgical anxiety level (On a scale of 0-100, with 0 being not anxious at all to 100 being extremely anxious, how anxious are you about your upcoming surgery?), their anticipated pain (On a scale of 0-10, with 0 being no pain at all and 10 being pain as bad as you can imagine, how much pain do you anticipate experiencing after your upcoming surgery?), and using a categorical scale, their anticipated pain medication need (On a scale of 0 to 5, with 0 being none at all, 1 being much less than average, 2 being less than average, 3 being average, 4 being more than average, and 5 being much more than average, how much pain medication do you anticipate needing after your upcoming surgery?)."
15900573|NCT03645239|Other|Questionnaires|Questionnaires including Hospital Anxiety and Depression Scale (HADS), EQ-5D-3L, Edinburgh Postnatal Depression Scale (EPDS), Pain Catastrophizing Scale (PCS), Central Sensitisation Inventory (CSI), pain survey and breastfeeding questionnaire will be administered to the patient.
15900574|NCT03645239|Other|Headspace|The mindfulness exercise mobile application, Headspace, will be downloaded into the patients' mobile devices. Patients will be asked to experience a mindfulness exercise for 10-30 minutes before delivery. HADS and pain score will be asked after the intervention.
15900575|NCT03645226|Diagnostic Test|Colonoscopy|All subjects will undergo standard mechanical bowel preparation with 4 liters of polyethylene glycol (Klean-Prep, Norgine Ltd., Middlesex, UK). Total colonoscopy will be performed by experienced endoscopists under conscious sedation with intravenous benzodiazepines and narcotics. A conventional intermediate-length colonoscope (Olympus Corporation, Tokyo, Japan) will be used. One mucosal biopsy will be taken in the descending colon. Biopsies will be performed using standard biopsy forces without needle (Olympus Corporation, Tokyo, Japan). Half of the samples will be immersed in 4 oC normal saline solution. All samples will be immediately sent to pathology department and will be stored in a -80 oC freeze for processing of microbiota analyses.
15900576|NCT03645213|Device|Virtual Reality Box|Virtual Reality box, a head-mounted display with stereo earphones transmits the cartoon image onto screens in front of the child's eyes. It was showed on Samsung Galaxy Note5 phone and Samsung Gear VR box /SM-R323N.
15900577|NCT03645213|Device|Tablet Computer|The tablet computer is a device that children watch on a 7-inch screen.
15900578|NCT03645200|Drug|Fluzoparib combined with Apatinib|"Fluzoparib :
~40mg.bid, morning and evening each time, interval of 12 hours or so, the first oral administration 72 hours later
~Apatinib :
~250mg or 500mg take one day, 72 hours later, the continuous drug delivery phase (B-C1D1) was entered into the Fluzoparib, that is, the Fluzoparib capsule with 40mg.bid, every morning and evening, each time, interval of 12 hours, the Apatinib tablets daily with the Fluzoparib capsule with the same service, fixed doses of 250mg or 500mg, daily. Continuous drug delivery for 28 days for one cycle"
15900579|NCT03645187|Drug|FOLFERI|FOLFERI regimen
15900580|NCT03645187|Drug|Folferi and celecoxib|Folferi regimen and celecoxib
15900581|NCT03645174|Device|Using long tube|Fiberoptic-guided intubation through LMA, using long tube
15900582|NCT03645174|Device|Aintree catheter|Fiberoptic-guided intubation through LMA, using Aintree catheter
15900583|NCT03645161|Diagnostic Test|rat and mouse skin test|Comparison between local and imported skin prick testing result of rat and mouse allergen extracts in respiratory allergy patients
15900584|NCT03645148|Biological|iNeo-Vac-P01|Neoantigen peptides
15900585|NCT03645148|Other|GM-CSF|immune adjuvant
15900586|NCT03645135|Other|Goal elicitation|Patients will be asked to list 2 goals for their visit
15900587|NCT03645122|Procedure|Stimulation|This study is a novel approach to studying neuroplasticity after stroke. Previous work in humans with incomplete spinal cord injury demonstrates that the resulting plasticity transiently enhances motor output, indicating that there is also therapeutic potential. This study will attempt to induce bi-directional plasticity in corticospinal-motoneuronal synapses serving an intrinsic hand muscle of the hemiparetic limb. Control experiments will be completed to provide evidence of the neurophysiological mechanism(s) mediating the effect and to examine behavioral effects.
15900588|NCT03645109|Dietary Supplement|Vitamin D3|Capsules with 5,000 IU of vitamin D3 once a day (one capsule)
15900589|NCT03645109|Other|Capsules with placebo (talcum food grade)|Capsules with placebo (talcum food grade)
15900590|NCT03645096|Drug|Pregnenolone 500 mg|Pregnenolone 500 mg capsule.
15900591|NCT03645096|Drug|Pregnenolone 800 mg|Pregnenolone 800 mg capsule.
15900592|NCT03645096|Drug|Placebo|Placebo capsule manufactured to mimic pregnenolone capsule.
15900593|NCT03645083|Behavioral|Telephone call|Participants in the intervention group receive a one-time telephone call reminder to attend follow-up treatment at the acupuncture clinic
15900594|NCT03645083|Behavioral|Text message|Participants in the intervention group receive a one-time text messaging reminder to attend follow-up treatment at the acupuncture clinic
15900595|NCT03645070|Device|multipolar and self expandable thermometer|Will be evaluated if a multipolar and self expandable thermometer is superior to no probe or to single probe thermometer at prevention of esophageal thermal injury.
15900596|NCT03645070|Device|Single probe thermometer|Will be evaluated if a single probe thermometer is superior to a multipolar and self expandable thermometer or to no probe thermometer at prevention of esophageal thermal injury
15900597|NCT03645057|Drug|Crisaborole|This topical ointment is FDA-approved to treat atopic dermatitis of moderate or less severity in children. Subjects will apply the topical ointment to all affected areas twice daily for 12 weeks.
15900598|NCT03645057|Drug|Tacrolimus 0.03% Ointment|This topical ointment is FDA-approved to treat atopic dermatitis in children. Subjects will apply the topical ointment to all affected areas twice daily for 12 weeks.
15900599|NCT03645031|Other|Acute Intermittent Hypoxia|AIH entails continuous breathing as the level of oxygen in the air is decreased, then returned to normal. Participants will alternate between breathing normal air and breathing hypoxic air (air that has less oxygen). Participants will complete a single 45 minute session of acute intermittent hypoxia (AIH). Breathing, muscle activity and heart activity will be monitored before, during and after the procedure. The intervals will last 1 minute each.
15900600|NCT03645031|Other|Sham Acute Intermittent Hypoxia|Participants will complete the sham acute intermittent hypoxia, consisting of a single 45 minute session of breathing air with normal oxygen levels. All aspects of this procedure will otherwise be the same as for the AIH procedure. Breathing, muscle activity and heart activity will be monitored before, during and after the procedure.
15900601|NCT03645018|Diagnostic Test|diagnosis with tomosynthesis|Re-evaluation of lung nodule detection rate at 5 years in patients with early diagnosis of lung cancer
15900602|NCT03645005|Behavioral|"My Guide (psychoeducation & self-management program)"|"My Guide is a Smartphone application incorporating elements informed by the extant literature, designed to improve quality of life and symptom burden among Hispanic breast cancer survivors. My Guide components are designed to improve breast cancer knowledge, cancer-relevant self-efficacy, stress and symptom management skills, Both intervention and active comparator conditions are administered to participants for 8 weeks."
15900603|NCT03645005|Behavioral|"My Health (health education program)"|"My Health is a health promotion Smartphone application with health education content on nutrition, and general advice on lifestyle choices and prevention. The My Health control content was based on similar content tested in other psychosocial interventions with cancer survivors. Both intervention and active comparator conditions are administered to participants for 8 weeks."
15900604|NCT03644979|Other|Skydiving|Tandem skydiving (with an experienced instructor)
15900605|NCT03644966|Dietary Supplement|Bifidobacterium infantis|Probiotics
15900606|NCT03644966|Other|Placebo|Sugar pill manufactured to mimic probiotic tablet
15900607|NCT03644966|Drug|Antibiotics|Per Infectious Disease Society guidelines for Antimicrobial treatment of uncomplicated cystitis and pyelonephritis in women
15900609|NCT03644940|Diagnostic Test|CustomSight|Subpopulation-specific clinical decision support (CDS) system for severe sepsis detection
15900610|NCT03644927|Behavioral|Progressive exercise training|The 12 week progressive exercise program gradually increases the walking/running intensity and length of exercise every 2 weeks for the first 6 weeks and then maintains the higher intensity level for weeks 7-12,. The exercise intensity is based on percentile targets defined by the baseline cardiopulmonary test (CPX test). Participants will be called at weeks 4 and 10 to assess and foster exercise motivation, using basic principles of motivational interviewing..
15900611|NCT03644927|Behavioral|Waitlist Control|Participants will be screened for eligibility and if randomized into the waitlist control group. Wait list participants will wait for 12-weeks before they can participate in the progressive exercise training program. The 12 week progressive exercise program is identical to the one used in the intervention group. Specifically, the 12 week progressive exercise program gradually increases the walking/running intensity and length of exercise every 2 weeks for the first 6 weeks and then maintains the higher intensity level for weeks 7-12,. The exercise intensity is based on percentile targets defined by the baseline cardiopulmonary test (CPX test). Participants will be called at weeks 4 and 10 to assess and foster exercise motivation, using basic principles of motivational interviewing..
15900612|NCT03644914|Behavioral|10-week Reading Program|Intervention sessions will be carried out during the school day in a private school room. In each session, the investigator will work with the child individually to help him or her read better. Intervention will incorporate word recognition and phonetic decoding of words established as meeting 1st grade essential literacy standards. Learning techniques will involve games, play, movement, music, and breaks (i.e., the child is able to move about and associate words with color, video, and music. Three 5-minute breaks will be integrated into each 1-hour session to allow the child time to rest and process learned material). Intervention will also use each child's personal interests as a context around which sight words will be learned.
15900613|NCT03644901|Procedure|nonsurgical periodontal treatment|patients will undergo nonsurgical periodontal treatment to reduce the relative attachment level and improve the probing depth. An initial session will be conducted to remove supra gingival plaque and calculus. another appointment is set to perform full moth scalling and root planing.
15900614|NCT03644888|Other|Cycle ergometer training|Already in arm/group descriptions
15900615|NCT03644888|Other|Airway clearance program|Already in arm/group descriptions
15900616|NCT03644888|Device|Vibration therapy|Already in arm/group descriptions
15900617|NCT03644888|Device|Sham vibration therapy|Already in arm/group descriptions
15900618|NCT03644875|Device|etacoat|Etacoat is a HPMC formulation intended to be used in ophthalmic anterior segment cataract surgery.
15900619|NCT03644862|Device|etafill|Etafill is a HA formulation intended to be used in opthalmic anterior segment cataract surgery.
15900620|NCT03644849|Device|CO2RE® (Syneron Candela Corp, Wayland, MA)|The intervention will include a single treatment of a lower extremity wound with ablative fractional carbon dioxide laser after MMS surgery.
15900621|NCT03644849|Other|Sham laser treatment|A physician who is not blinded will perform a sham laser treatment on blinded subjects.
15900622|NCT03644836|Drug|Amino Acids|Sweet taste cocoa flavored drink
15900623|NCT03644836|Drug|Placebos|Sweet taste cocoa flavored drink
15900624|NCT03644823|Drug|Atezolizumab|PDL1- inhibitor
15900625|NCT03644823|Radiation|Radiotherapy|6 Gy x 3
15900626|NCT03644810|Diagnostic Test|PPT measurement|The sensitivity to pressure which is gradually increased is assessed. The procedure is performed at the back and the lower leg
15900627|NCT03644810|Diagnostic Test|Pain catastrophizing scale|A validated questionnaire that measures three domains of pain-related catastrophizing thoughts: helplessness, rumination and excessive magnification
15900628|NCT03644810|Procedure|Cold Pressor Test|The participant submerges one hand into a tank of cold (5 deg C), circulating water. The procedure is commonly know to decrease the sensitivity to pressure (PPT procedure) so that a difference appears in pain sensitivity when comparing PPT values before and after the procedure
15900629|NCT03644797|Genetic|Exome sequencing|Detection of a second (likely) pathogenic molecular event on exome data for intellectual disability beyond the 16p13.11 Copy Number Variant.
15900630|NCT03644784|Diagnostic Test|Standardized protocol for assessing aortic regurgitation using videodensitometry|Standardized protocol for assessing aortic regurgitation using videodensitometry
15900631|NCT03644771|Drug|Acthar|4 treatment periods of 3 months each with 20 units biweekly, 40 units biweekly, and 80 units biweekly, with a tapering period to no drug for the fourth 3 month period. Then one year f/u.
15900632|NCT03644758|Diagnostic Test|socio-demographic data and personal medical history|Socio-demographic data and personal medical history is a self-administered questionnaire.
15900633|NCT03644758|Diagnostic Test|Pittsburgh Sleep Quality Index (PSQI)|Pittsburgh Sleep Quality Index (PSQI) is a self-administered questionnaire. This score evaluates sleep disturbances.
15900634|NCT03644758|Diagnostic Test|Epworth Sleepiness Scale|Epworth Sleepiness Scale is a self-administered questionnaire. This score evaluates excessive drowsiness.
15900635|NCT03644758|Diagnostic Test|Insomnia Severity Index (ISI)|Insomnia Severity Index (ISI) is a self-administered questionnaire. This score evaluates insomnia severity.
15900636|NCT03644758|Diagnostic Test|stop-BANG questionnaire|Stop-BANG is a self-administered questionnaire. This score evaluates Obstructive Sleep Apnea (OSA).
15900637|NCT03644745|Behavioral|VM @ Home Usability|Our primary outcome measures will be use of the coaching system features, level of daily physical activity, mood, self-efficacy, and user satisfaction. Secondary outcomes that will inform our further development and be important outcomes in subsequent trials include user adherence to their coaching goals, physical function and level of socialization. For the pilot study, we plan to assess physical function and level of socialization at baseline and at the end of 3 months. For the other outcome measures, we will be able to integrate the data collection into the VM@Home platform and coaching process.
15900638|NCT03644732|Procedure|SEEG Group|Visual and quantitative SEEG signal analysis. As available, collection of behavioral and neuropsychological postsurgical data
15900639|NCT03644719|Behavioral|Cognitive behavioral skills training|A brief cognitive behavioral skills training was applied to teach ketamine abusers about stimulus control, refusal skills, communication skills, decisional balance, and infectious diseases prevention.
15900640|NCT03644706|Drug|ADV7103|Each dose of ADV7103 contains a fixed ratio of 1/3 of ADV7103-CK (potassium citrate) and 2/3 of ADV7103-BK (potassium bicarbonate) based on the mass of active substances. The strength is 6.44 (± 10 %) mEq/g of ADV7103 (alkalinizing power).
15900641|NCT03644706|Drug|Placebo|"Placebo is a combination of 2 mm green coated lactose granules and 2 mm white coated lactose granules.
~Each dose of placebo contains a fixed ratio of 1/3 of green granules and 2/3 of white granules."
15900642|NCT03644693|Dietary Supplement|Nutritional Formulation Containing Exogenous Ketones|A nutritional formulation providing beta-hydroxybutyrate, 2g of carbohydrate, 1g of protein, and 9g of fat, plus minerals, per 100kcal. Given orally as food or beverage three times daily.
15900643|NCT03644693|Dietary Supplement|Placebo Formulation|A placebo formulation providing similar amounts of carbohydrates, proteins and minerals as the nutritional formulation. Given orally as food or beverage three times daily.
15900644|NCT03644680|Diagnostic Test|Nasal Provocation with Birch Extract|Nasal spray containing birch extract from Allergopharma
15900645|NCT03644680|Other|Nasal Provocation with NaCl 0.9%|Nasal spray containing sterile sodium chloride 0.9%
15900646|NCT03644667|Biological|tocilizumab|6 doses: 8mg/kg (maximum of 800 mg) given once every four weeks by intravenous infusion over a 20-week period, with a minimum of 21 days between each infusion.
15900647|NCT03644667|Biological|Placebo|The placebo is 0.9% sterile normal saline. 6 doses: 8mg/kg (maximum of 800 mg) given once every four weeks by intravenous infusion over a 20-week period, with a minimum of 21 days between each infusion.
15900648|NCT03644667|Drug|Standard of Care Triple IS|"Standard of care triple maintenance IS includes:
~A calcineurin inhibitor-tacrolimus (Prograf ®) per site standards by sublingual, oral or intravenous route to attain target trough levels.
~Exception: Should a participant be unable to tolerate tacrolimus, the site physician investigator may choose cyclosporine treatment.
~An anti-proliferative treatment-mycophenolate mofetil or Myfortic® (enteric-coated mycophenolate sodium) will be administered, per protocol.
~Exception: Should a participant be unable to tolerate mycophenolate mofetil, the site physician investigator may choose an alternative treatment.
~Steroids-methylprednisolone/prednisone dosing will be given according to the local center standard of practice early post transplantation. After 6 months, prednisone may be withdrawn at the discretion of the site physician investigator, per protocol."
15900649|NCT03644654|Procedure|Standard care group|Patient will receive 2 ml/kg/hour of crystalloids (Ringerfundin BBraun) intraoperatively. Fluid boluses will be used according to anesthesiologists decision (timing and amount of fluids). In case of drop of mean arterial pressure (MAP) below 65 mmHg norepinephrine will be started (with initial bolus of 5 - 10 ug).
15900650|NCT03644654|Procedure|Noninvasive monitoring group|Patient will receive 2 ml/kg/hour of crystalloids (Ringerfundin BBraun) intraoperatively. In case of hypotension (defined as a mean arterial pressure below 65 mmHg), the intervention will be led according to a protocol based on cardiac index, systemic vascular resitance and stroke volume variation (SVV) values (ClearSight, Edwards).
15900651|NCT03644641|Procedure|Desflurane Group|General anesthesia will be held using desflurane in end- tidal concentration according to target value of entropy levels (between 40 and 60).
15900652|NCT03644641|Procedure|Propofol Group|General anesthesia will be held using Schnider effect model for propofol (target control anesthesia). Titration will be done according to target value of entropy levels (between 40 and 60).
15900653|NCT03644628|Procedure|Laparoscopic repair of anterior and apical pelvic organ prolapse|Surgical correction of anterior and apical pelvic organ prolapse by laparoscopy
15900654|NCT03644615|Other|Mindfluness and usual care|Intervention based on a mindfulness training program as a therapeutic alternative in osteoarthritis of the knee or hip. Mindfulness is a technique of attention training, which is to focus one's attention on the present moment and to examine the sensations that come to mind, how they appear, how they last time, and how they disappear.
15900655|NCT03644615|Other|Usual care|No intervention on the patients
15900656|NCT03644602|Dietary Supplement|low FODMAPs diet|Low FODMAPs diet was a diet containing low amount of poorly absorbed short-chain carbohydrates (Fermentable, Oligo-, Di-, Mono-saccharides And Polyols)
15900657|NCT03644589|Biological|Pembrolizumab|200mg,Given intravenous (IV) infusion, every 21 days
15900658|NCT03644589|Drug|Cisplatin|75mg/m2, intravenous (IV) infusion, every 21 days, for 6 cycles Given IV
15900659|NCT03644576|Drug|ozanimod|ozanimod
15900660|NCT03644576|Drug|Pseudoephedrine|Pseudoephedrine
15900661|NCT03644576|Drug|ozanimod placebo|ozanimod placebo
15900662|NCT03644550|Drug|LMB-100|Given IV at RP2D on days 1, 3 and 5 of two (2) 21 day cycles.
15900922|NCT03642561|Device|transarterial chemoembolization(TACE)|TACE treatment is a first line treatment for BCLC stage B HCC
15900663|NCT03644550|Biological|Pembrolizumab|Given IV at approved dose on day 1 of each 21 day cycle, starting with cycle 3, for up to 2 years with the option of a second course for patients meeting criteria.
15900664|NCT03644537|Procedure|Orthodontic intrusion|"27 female patients coming to the Orthodontic department, Cairo University seeking orthodontic treatment, where their age ranges from 15 - 18 years, where their treatment plan include extraction of upper first premolars, and using the split-mouth technique, one side will be control group without application of force where the other side will receive intrusive mechanics for the same patient in the upper arch (one side will not receive any force and the same tooth on the other side of the arch will suffer intrusive mechanics, that's why named SPLIT MOUTH TECHNIQUE - as if the arch is split into two subjects, one control subject (tooth) and the other study subject (tooth) . According to the amount of force of the working side, the total number of patients will be divided into 3 groups.
~Each of 9 subjects, the first group where a light force will be applied (10 gm), the second group where moderate force will be applied (25gm), the third group where heavy force will be applied(100 gram)."
15900665|NCT03644524|Behavioral|Heat therapy|Regular hot tub use
15900666|NCT03644511|Drug|Regorafenib (Stivarga, BAY73-4506)|Prescribed by physician.
15900667|NCT03644511|Drug|Sorafenib (Nexavar, BAY43-9006)|Prescribed by physician.
15900668|NCT03644498|Other|Non-Interventional|Non-Interventional
15900674|NCT03644472|Drug|nitrate rich beetroot juice|This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK).
15900675|NCT03644472|Drug|nitrate depleted beetroot juice|This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK).
15900676|NCT03644459|Biological|LYN00101|"Concentrate for intravenous infusions (10 mg / ml) with Molecular Weight 150 - 151 kDa.
~Each cycle of treatment consists of 24 weeks. Patients who enroll into this study will receive an infusion of assigned dose of LYN00101 biweekly. No intra-patient dose escalation is allowed. The proposed dose escalation sequence is 10mg/kg, starting from 8 mg/kg."
15900677|NCT03644446|Biological|Bisoprolol plasma residual concentration dosage|Bisoprolol plasma residual concentration dosage will be subsequently studied by renal function (altered if creatinine clearance < 30mL/min, mild altered between 30-60mL/min, normal > 60mL/min as estimated by the CKD-EPI formula)
15900678|NCT03644433|Procedure|Single layer closure|Uterine incision will be approximated with continuous unlocked suture avoiding the inclusion endometrium and without trimming incision edges.
15900679|NCT03644433|Procedure|Double layer closure after resection uterine scar|Uterine incision will be trimmed and old scar tissue will be removed. Then first, endometrium will be approximated by continuous unlocked suture mimicking subcuticular suture avoiding the inclusion of endometrium and second, upper part of myometrium will be approximated by a continuous unlocked suture.
15900680|NCT03644420|Diagnostic Test|Clinical evaluation|Functional scores for the pathological joint will be determined
15900681|NCT03644420|Diagnostic Test|Radiology|
15900682|NCT03644420|Diagnostic Test|Dynamic contrast-enhanced magnetic resonance imaging|Patients will be examined using a 3T MR scanner (MR 750W, General Electrics, Milwaukee, WI) with a dedicated knee coil. Subchondral bone marrow vascularization in medial and lateral femorotibial compartments will be assessed with DCE-MRI and lesions will be graded on MR images.
15900683|NCT03644420|Diagnostic Test|Evaluation of histological status|Upper tibial resection pieces will be collected and the vascularization will be determined according to the OARSI score
15900684|NCT03644407|Other|Spine Surgery|Patients undergoing spine surgery, who are the subjects eligible for participation to this observational prospective registry
15900685|NCT03644394|Device|Implantation of IMES sensors|Surgical implantation of IMES sensors during routine surgery to improve prosthetic control
15900686|NCT03644381|Other|Oral Immunotherapy|Starting from a very low level and over a period of several months, participants in the treatment group receive escalating doses of milk. Participants will also have blood and saliva draws to assess parameters of their immune system as well as skin prick testing
15900687|NCT03644355|Behavioral|Lifestyle counseling|Inter-disciplinary, interactive, family based behavioral intervention for overweight children
15900688|NCT03644342|Drug|Nirapaib|(see treatment regimen and method of treatment assignment)
15900689|NCT03644329|Other|Control group|The volunteers will not performed the interventions.
15900690|NCT03644329|Other|Lower-load resistance training (LL)|The volunteers will be perform the resistance training, three times a week for 12 weeks on non-consecutive days, three sets with 30% of 1RM and repetition until or close to failure in each set and 1.5-min of rest between sets and exercises.
15900691|NCT03644329|Other|Higher-load resistance training (HL)|The volunteers will be perform the resistance training, three times a week for 12 weeks on non-consecutive days, three sets with 80% of 1RM and repetition until or close to failure in each set and 1.5-min of rest between sets and exercises.
15900692|NCT03644329|Other|Higher-volume resistance training (HV)|The volunteers will be perform the resistance training, three times a week for 12 weeks on non-consecutive days, six sets with 80% of 1RM and repetition until or close to failure in each set and 1.5-min of rest between sets and exercises.
15900693|NCT03644316|Device|BandGrip skin closure device|topical skin closure device
15900694|NCT03644303|Radiation|SBRT + ADT|Short course SBRT to 1 or 2 oligo-progressing metastases in addition to continued abiraterone or enzalutamide
15900695|NCT03644290|Behavioral|Cognitive training|Five sessions of semantic strategy training and face-name association training
15900696|NCT03644290|Behavioral|Control Condition|Five sessions of active control information and education
15900697|NCT03644277|Other|Acute Intermitted Hypoxia|Subjects will be fitted with a latex-free full non-rebreather mask with a custom neoprene head strap, mask and oxygen delivery system are commonly used for altitude training. The mask will first provide a normoxic air (room air) mixture (FiO2 = 0.21) via the mask.
15900698|NCT03644277|Procedure|Massed Practise|"Address gross upper extremity movements, grip and pinch strength, and coordination.
~Tasks utilized may include, but are not limited to: lifting a weighted can, squeezing, cutting paper, popping bubble wrap, translating different resistance clothespins, etc. The ultimate goal of the session is to achieve a total of 300 repetitions during training. Task difficulty may be progressed (making it more difficult), if the participant is able to achieve >100 repetitions in less than 15 minutes, on two different occasions. A task may be made easier if the participant is unable to achieve 50 repetitions of a task within 15minutes. Progressing a task may include: changing the task, addition of resistance, increasing the range of motion required for a task to be deemed successful, increasing/decreasing the size of the object used. The number of total repetitions and any item progressions will be recorded."
15900699|NCT03644277|Other|Rapael Glove|The Rapael Smart Glove is a virtual reality hand exoskeleton rehabilitation device. The tasks selected will address gross movement and hand function during a 45 minute session. Additional time may be required for device set up and activity selection/modification. Tasks utilized will include, but are not limited to: fly swat, throwing darts, squeezing an orange, catching a baseball, and floating fish. Tasks will be modified based on participants' perceived fatigue and challenge levels, as determined by a rating from 0-10. The participant goal will be to maintain the task difficulty between a 5-8/10 range. This would depict a moderate to difficult task rating, but an ability to complete the task. Progressing a task may include: changing the task, addition of resistance, increasing the range of motion required for task success, and increasing the duration of contraction. The number of total repetitions and activity outcomes will be recorded.
15900700|NCT03644264|Drug|PA21|sucroferric oxyhydroxide is a mixture of polynuclear iron(III)-oxyhydroxide (about 33% m/m), sucrose (about 30% m/m), and starches (about 28% m/m) and contains ≤10% m/m water.
15900701|NCT03644264|Drug|sevelamer carbonate|sevelamer carbonate tablets containing 800 mg of sevelamer carbonate.
15900702|NCT03644251|Other|amniotic and umbilical cord matrix|Cryopreserved human amniotic and umbilical cord product derived from donated human placental tissue following healthy, live, caesarian section, full-term births after determination of donor eligibility and placenta suitability.
15900703|NCT03644238|Diagnostic Test|Oral Glucose Tolerance Test|75g of glucose is consumed
15900704|NCT03644238|Behavioral|Inactivity|Lying or sitting down.
15900705|NCT03644238|Behavioral|Physical activity|20 minutes of fixed intensity exercise on a bicycle ergometer.
15900706|NCT03644225|Device|Measurment with Aspirational Medical Device|The mechanical properties of healthy and SSc-diseased skin will be assessed by suction based measurements with a new developed Aspirational Medical Device.
15900707|NCT03644225|Device|Measurment with Cutometer MPA 580|The mechanical properties of healthy and SSc-diseased skin will be assessed by CE-marked Cutometer MPA 580
15900708|NCT03644212|Drug|Vitamin D3|Sixty-three vitamin D deficient women (16 with PCOS and 47 without PCOS) were supplemented with 50.000 IU of oral vitamin D3, once weekly for 8 weeks. Serum 25-hydroxyvitamin D (25OH-D), sRAGE and AMH levels were checked before and after treatment.
15900709|NCT03644199|Other|Oral Glucose Tolerance Test (OGTT) assessment arm|Hormonal and motility responses to a standard OGTT evaluation arm
15900710|NCT03644199|Other|Mixed meal test evaluation test arm|Evaluate the hormonal and motility responses to a standard mixed meal test through the day
15900718|NCT03644173|Behavioral|Personal Resilience Empowerment Program including 5 sessions with health coaches|5 coaching sessions that will take place either in-person or over the phone with a research nurse (RN)-Health Coach. During the sessions, the health coach will focus on introducing the 5 pillars of health and well-being: sleep, activity, purpose, nutrition and resilience. Will introduce breathing techniques participants and will teach patients how to acquire mind-body skills to assist in stress management, learn to thrive by building resilience, feel empowered to manage their health, gain self-care skills to decrease anxiety, pain and nausea naturally, control the stress response and trigger the relaxation response to promote well-being and discover what foods fuel the body in preparation for healing, during recovery and overall health.
15900719|NCT03644160|Behavioral|Physical activity and behaviour change|The intervention group (group A) will receive an 8 week individualised, tailored behaviour change intervention to promote PA and an information booklet about physical activity to include an initial 1:1 session with a physiotherapist with training in behaviour change techniques and motivational interviewing. Using a range of behaviour change and self-regulation techniques (eg goal-setting, self-monitoring), participants will be guided towards physical activity maintenance at the end of the 8 weeks. In addition, participants will be signposted to physical activity classes, facilities and resources in the local community. This group will continue with their routine care for their condition throughout the study period.
15900720|NCT03644147|Drug|Acetaminophen|Acetaminophen will be intravenously administrated to treatment group after the end of surgery.
15900721|NCT03644134|Behavioral|Assessment of physiological stress and sleep pattern|The personalized intervention consists of (i) information session (ii) pre-assessment (first assessment) of stress and recovery levels, and sleep patterns (iii) individual feedback sessions and action plans based on the outcomes of the initial assessment (iv) monitoring and follow-ups (v) post-assessment (second assessment) of stress and recovery levels and sleep patterns.
15900722|NCT03644108|Drug|Mucinex® ER 600 mg|Single dose of Mucinex® 600 mg ER Bi-Layer tablet
15900723|NCT03644095|Drug|Mucinex® SE|Single dose of Mucinex® SE extended-release 600 mg bi-layer tablet
15900724|NCT03644095|Drug|Vicks Cough Syrup for Chesty Coughs|Vicks Cough Syrup for Chesty Coughs 15 mL (200 mg guaifenesin q4h) immediate release (IR) syrup
15900725|NCT03644082|Behavioral|Luminosity Trial Memory Match|Working memory task that has users indicate whether the current symbol matches the one presented 2 symbols previously. As the user makes correct responses, the previous symbols reduce in contrast and fade int the background, ultimately disappearing, forcing the user to rely entirely on working memory to achieve success
15900726|NCT03644082|Behavioral|Luminosity Trial Memory Matrix|The purpose id to remember the location of squares on a grid
15900727|NCT03644082|Behavioral|Luminosity Trial Famliar Faces|The purpose is to create associations between visual and verbal information
15900728|NCT03644082|Behavioral|Luminosity Trial Brain Shift|The purpose is to decide whether or not cards with numbers and letters are either even or vowels. This measures inhibition, flexibility, and monitoring response set. Also, letterfluency, category fluency, and category switching.
15900729|NCT03644082|Behavioral|Luminosity Trial Star Search|The purpose is to visually scan several different objects and find the different object in array of pictures. This measures selective attention.
15900730|NCT03644082|Behavioral|Luminosity Trial Word Bubbles|"The purpose is to decide what suffix to use in order to complete a word whena prefix is given. The subject needs to come up with he ending of three different prefixes to complete the word.
~This task measures verbal modality, deductive reasoning, integration of multiple bits of information, and flexibility of thinking."
15900731|NCT03644082|Behavioral|Luminosity Trial Color Match|The purpose is to identify whether colors and words match each other. This measures the ability to inhibit a dominant and automatic verbal response
15900732|NCT03644082|Behavioral|Luminosity Trial Ebb and Flow|Identify which direction leaves are pointing or moving depending on their color.This measures inhibition of impulsive and perseverative responding, and the ability to establish and maintain instructional set.
15900733|NCT03644082|Behavioral|Luminosity TrialChalk Board Challenge|purpose is to problem solve quantitative reasoningequationsand to decide which card is greater or if the 2 cards are equal when the math problem is solved.
15900734|NCT03644082|Behavioral|Luminosiuty Follow that Frog|The purposeis to remember the path a red frog takes as it jump from lilypad to lily pad in a pond. This measures flexibility of thinking on a visual-motor sequencing task and working memory
15900735|NCT03644082|Behavioral|Luminosity Train of Thought|purpose is to guide specific colored trains into corresponding colored matching houses by attending to the different tracks. This measures divided attention.
15900736|NCT03644069|Biological|Nexvax2|Nexvax2 subcutaenous (SQ) injections: 32 in total, at twice weekly intervals
15900737|NCT03644069|Biological|Placebo|Placebo SQ injections: 32 in total, at twice weekly intervals
15900738|NCT03644056|Drug|IMC-001|Different IMC-001 dose level for each cohort group (IMC-001 2 mg/kg etc. every 2 weeks)
15900739|NCT03644043|Device|EEG scan|WAVi EEG and evoked potential platform. Participants will be scanned using the ElectroCap (FDA Class II) and/or the WAVi Headset with the WAVi Co EEG P300 system, along with the structured clinical interviews and assessments for the various ailments or baseline screenings
15900740|NCT03644017|Device|WRAPSODY Stent Graft Placement|The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
15900741|NCT03644004|Other|frequency of diabetes mellitus, type 2, diagnosis in patients with medical history of gestational diabetes.|"Patients will be contacted by mail with sending of the information notice to ask them to participate in the study.
~If they don't reply, the subjects will be called by phone by the investigator to collect their non opposition of participation at the study.
~During this call, the investigator will be able to answer all the questions about the study.
~The report of this telephone conversation will be register in the medical file of the patient.
~Then, we will collect informatic data from the hospital concerning the patients.
~After that they will be contacted by phone to answer a survey. Beside, another secure survey will be send by email to each patient's family doctor.
~To finish, crossing data between those of the patients and the family doctor and anonymisation of the data."
15900742|NCT03643991|Other|Weighted Blanket|Weighted blanket will be given to patients based on the patient weight (10% of patients body weight) for three nights while on inpatient unit.
15900743|NCT03643978|Other|Decision aid|The decision aids aim to inform the patients about the diagnosis and the treatment options. They aim to help the patient prioritize and make an informed decision.
15900744|NCT03643965|Drug|Nefecon|Nefecon 16 mg for daily administration by mouth for 9 months.
15900745|NCT03643965|Drug|Placebo oral capsule|Placebo capsules for daily administration by mouth for 9 months.
15900746|NCT03643952|Drug|Daptomycin for Injection|Once daily administration of 5, 7, 9, 10, or 12 mg/kg intravenous (IV) daptomycin infused with 25-50 mL saline over 30-60 minutes depending upon infection type and age level.
15900747|NCT03643939|Device|High Flow Nasal Catheter|"HFNC will deliver through AIRVO2. FiO2 from 21 to 100% and heated humidified gas flow up to 60 l / min with temperature of the circuit maintained at 37 degrees.
~Oxygen flow will be offered through a humidified nasal catheter. Flow and FiO2 will be titrated according to the protocol to maximize patient´s comfort and SpO2."
15900748|NCT03643939|Device|Noninvasive ventilation|NIPPV will be performed using a facial mask (either oronasal or full face). NIPPV will deliver pressures and FiO2 tailored to specific ARF subgroups, according to the protocol. Adjustments of the inspiratory pressure (IPAP) and expiratory pressure (EPAP) and FiO2 according to protocol
15900749|NCT03643926|Procedure|Arthroscopic Brostrom|Brostrom-Gould lateral ligament ankle reconstruction performed by arthroscopic view
15900750|NCT03643926|Procedure|Open Brostrom|Brostrom-Gould lateral ligament ankle reconstruction performed by an open approach.
15900751|NCT03643913|Procedure|Deep neuromuscular block|Deep neuromuscular block requiring higher doses of Esmeron to target a post tetanic count (PTC) of 1-2 and higher doses of Bridion to reverse the block (4mg/kg).
15900752|NCT03643913|Procedure|Moderate neuromuscular block|Normal neuromuscular block requiring dosis of Esmeron to target a train of four (TOF) count of max 2 and lower doses of Bridion to reverse the block (2mg/kg).
15900753|NCT03643913|Drug|Neuromuscular Blocking Agents and reversing agents|Deep neuromuscular block versus moderate neuromuscular block.
15900754|NCT03643900|Device|pancreatic duct stenting|Place the pancreatic duct stent
15900755|NCT03643900|Drug|rectal indomethacin|rectal indomethacin 100mg at preoperative 30min
15900756|NCT03643887|Drug|FMT Capsule DE|30 capsule one-time oral dose
15900757|NCT03643887|Drug|Placebo oral capsule|30 capsule one-time oral dose
15920244|NCT03496207|Drug|Placebo|Placebo
15900758|NCT03643874|Drug|Halix albuterol 90 mcg|albuterol unit dose disposable DPI delivers 90 mcg of albuterol in the excipient lactose with each inhalation. Albuterol 90 mcg will be given on one of the treatment days in cumulative doses up to a total dose of 720 mcg
15900759|NCT03643874|Drug|albuterol HFA MDI 90 mcg|albuterol HFA MDI delivers 90 mcg of albuterol with each inhalation. Albuterol 90 mcg will be given on one of the treatment days in cumulative doses up to a total dose of 1440 mcg
15900760|NCT03643861|Radiation|5 Fraction Stereotactic Body Radiation Therapy|Stereotactic body radiation therapy (SBRT) has gained favor in the treatment of select central nervous system, lung, and abdominal malignancies due to its ability to deliver highly conformal doses of radiotherapy while using sharp dose gradients to deliver comparatively lower doses to the surrounding normal tissue. Utilization of SBRT is more labor intensive than conventional fractionation and requires precise immobilization and localization techniques with daily image guidance with direct physician and physicist oversight for all treatments. While more labor intensive and often utilizing more advanced technologies, SBRT allows the advantage of reducing setup margins compared to conventionally fractionated treatment while being able to shorten overall treatment times due to the ability to safely dose escalate high risk areas
15900761|NCT03643848|Behavioral|Sleep with Sound Cues|Experimental manipulation to observe effects on memory for learned material.
15900762|NCT03643848|Behavioral|Sleep with Sham Cues|Sham manipulation
15900763|NCT03643835|Device|Thermal Rehab Machine|The Polar Breeze unit is a microenvironmental air-chiller. That means it is a single-pass air-conditioner capable of cooling external air
15900764|NCT03643835|Other|Forearm Ice Towels|Towels that are wetted with ice water and wrapped around participants forearms (length of arm from wrist to elbow)
15900768|NCT03643796|Drug|Remifentanil|Remifentanil infusion of 0.05 to 0.2 mcg/kg/minute started just prior to induction and stopped at emergence from anesthesia.
15900769|NCT03643796|Drug|Ketamine|Ketamine infusion of 2 mcg/kg/minute will be started at induction. It will be stopped at the beginning of the emergence from anesthesia, roughly 45 minutes from extubation.
15900770|NCT03643796|Drug|Dexmedetomidine|dexmedetomidine bolus of 0.5 mcg/kg over 10 minutes starting 5 minutes prior to induction followed by an infusion of 0.2-0.7 mcg/kg/hour that will be stopped with the start of closing the surgical wound.
15900771|NCT03643770|Combination Product|Upper extremity training/Armeo Spring|Armeo Spring is a gravity support system based on an ergonomic arm exoskeleton with integrated springs.
15900772|NCT03643757|Procedure|Thoracic epidural analgesia|Before the initiation of the procedure, in the intervention group epidural catheter was inserted by loss of resistance method at the level of T3-T7 with the help of an 18 G Thuohy needle (Pajunk, Geisingen, Germany) while the patient was on sitting position. A test dose of 2 ml, 2% Lidocaine HCL was administered through the catheter. Once, efficacy was confirmed, 10 ml bolus dose of 0.1% Bupivacaine was injected. Analgesia maintenance was provided by infusion of 0.1% Bupivacaine (0.1 ml/kg/hour) both intra- and postoperatively for 24 hours.
15900773|NCT03643757|Drug|Bupivacaine|In addition to multimodal analgesia protocol, epidural bupivacaine was administered in TEA arm and pain relief was achieved by intravenous pethidine infusion in IVA arm.
15900774|NCT03643744|Drug|Celecoxib 200mg|14 Celecoxib 200mg taken 1 in the morning and 1 in the evening.
15900775|NCT03643744|Drug|Placebo|14 placebo capsules taken 1 in the morning and 1 in the evening.
15900776|NCT03643731|Device|HeatTens (HV-F311-E)|Patients need to apply the device during 30 minutes.
15900777|NCT03643718|Procedure|Emergency General Surgery|Emergency General Surgery and Trauma operative/non operative management
15900778|NCT03643705|Other|Multi-component intervention|4 components as described
15900779|NCT03643705|Other|General prevention education|General education as described
15900780|NCT03643692|Device|ARISES|The Adaptive, Real-time, Intelligent System to Enhance Self-care of chronic diseases (ARISES) project will use type 1 diabetes (T1DM) as an exemplary case study to demonstrate safety, technical proof of concept and efficacy of a novel mobile platform. Combining wearable sensors and smartphone technology, a range of biological, environmental and behavioural data will be analysed to provide real-time therapeutic and lifestyle decision support. Using Case-Based-Reasoning (CBR), the system will be adaptive and personalised with the ability to learn from previously encountered scenarios. Ultimately, ARISES aims to empower self-management of chronic illness and limit the complications associated suboptimal treatment.
15900781|NCT03643679|Other|Kwit smartphone app|The Kwit smartphone app combines several popular features of tobacco cessation apps, including game-like features (e.g., unlocking achievement milestones for completing cessation-related tasks), useful statistics (e.g., money saved), and an ability to share progress with friends. Users can actively engage with the app to track cravings or view progress, such as life expectancy gained. A passive component notifies users when milestones have been achieved, e.g., when blood no longer contains nicotine. Motivational messages can be actively requested at any time; they can also appear unsolicited, as when the user logs cravings.
15900782|NCT03643666|Drug|dexamethasone|before closure of the laparoscopic entering sites the patients will receive instillation of 40 ml of normal saline containing 16mg dexamethasone
15900783|NCT03643666|Drug|magnesium sulphate|patients will receive instillation of 40 ml of normal saline containing 16mg dexamethasone plus magnesium sulphate 2 gm into the peritoneum at the end of the operation
15900784|NCT03643666|Drug|Placebo (saline)|before closure of the laparoscopic entering sites the patients received instillation of 40 ml normal saline into the peritoneum
15900785|NCT03643640|Behavioral|Optimune|Optimune is a web-based psychological intervention developed for women with breast cancer.
15900786|NCT03643640|Other|Care-As-Usual|Participants are free to continue to engage with any treatment they require (i.e., CAU).
15900787|NCT03643627|Drug|SYNT001|single IV infusion
15900789|NCT03643614|Procedure|Injection of autologous regenerative cells of adipose tissue|Autologous regenerative cells of adipose tissue obtained by enzymatic digestion of lipoaspirate are injected diffusively in the submucosal plane of the rectum and vagina with a sharp 27G needle. Adipose tissue that has not been subjected to enzymatic processing is injected through the punctures on the skin into the deep layers of the rectovaginal septum by means of cannula of 1.0-1.2 mm in diameter, 70 mm in length, 0.1-0.2 ml in one retrograde pass of the cannula.
15900790|NCT03643601|Other|Non-Interventional|Epidemiological overview of CKD-associated anemia and treatment patterns, rather than to evaluate specific drugs
15900791|NCT03643588|Device|HYAJOINT Plus|Single-injection, 60 mg / 3 ml (2%) cross-linked hyaluronan
15900792|NCT03643588|Device|Hyalgan|Three-injection, 20 mg / 2 ml (1%) linear hyaluronan
15900793|NCT03643575|Drug|Vicks Cough Syrup for Chesty Coughs|Vicks Cough Syrup for Chesty Coughs 15 mL (containing 200 mg guaifenesin) IR syrup with 240 mL of water
15900794|NCT03643575|Drug|Robitussin Extra Strength Chest Congestion|Robitussin Extra Strength Chest Congestion 5 mL (containing 200 mg guaifenesin) IR syrup with 240 mL of water
15900795|NCT03643575|Drug|Organ-I- NR tablet|Organ-I- NR tablet (containing 200 mg guaifenesin) with 240 mL of water
15900796|NCT03643562|Drug|Adrabetadex|administered via lumbar puncture and intra-thecal infusion
15900797|NCT03643549|Drug|Bortezomib and Temozolomide Phase IB|In the Phase IB of the study the following dose escalation of TMZ will be performed: The first cohort of 3 patients will receive 150 mg/m2 of IMP (TMZ) for 5 days q4w. If one patient in this cohort develops a dose limiting toxicity, another cohort of 3 patients will be treated at the same dose level until 2 or more patients in the group of 3-6 develop DLT.
15900798|NCT03643549|Drug|Bortezomib and Temozolomide Phase II|The patientes will be treated with the maximum recommended starting dose of Temozolomide and Bortezomib established in the IB phase of the study
15900799|NCT03643536|Other|12-WPEP|The 12-WPEP (week physical exercise program) was carried out in 3 sessions each 40 or 60minutes with alternate days per week during 3 months, and with an intensity between 40 to 80 percent of their VO2 max, as the AHA recommends
15900800|NCT03643523|Diagnostic Test|Albumine detection|Control of serum albumine levels in postoperatori of colorectal surgery
15900801|NCT03643510|Drug|Fulvestrant|Fulvestrant will be dosed 500mg intramuscularly (IM) on days 1 and 15 during cycle 1 and then on Day 1 during subsequent cycles.
15900802|NCT03643510|Drug|Abemaciclib|Abemaciclib 150 milligrams mg orally once every 12 hours on days 1-28.
15900803|NCT03643497|Drug|anti-infective drugs|According to the models of population pharmacokinetics, the investigators and want to correlate use of antibiotics with treatment effectiveness and safety in children
15900804|NCT03643471|Device|MRI|Magnetic resonance imaging with advanced sequences including volumetry, spectroscopy and tractograpghy.
15900805|NCT03643445|Behavioral|Motivational Orientated Treatment|The motivation-oriented treatment condition is intended to create a context for treatment that is patient-centered, non-judgmental, and will create a therapeutic environment wherein patients can make an informed decision around their goals for treatment and their willingness to commit to the behavioural changes required for recovery from an eating disorder. In general, MI is a psychotherapeutic stance aimed at helping patients in resolving ambivalence toward change and increasing their intrinsic motivation to engage in healthy behaviour choices.
15900806|NCT03643445|Behavioral|Psychoeducation-Oriented Treatment|The psychoeducation-oriented treatment condition is intended to teach patients about the causes of eating disorders, the expected course of recovery, obstacles to recovery, and the importance of behavioural changes required for recovery from an eating disorder. In this condition, in order to maximize the differences between groups, no attention will be given to discussing the patient's stage of change, their level of motivation, or their own personal values around recovery. Rather, emphasis during individual meetings with their therapist will be on the importance of symptom abstinence and normal eating.
15900807|NCT03643432|Behavioral|Exercise adherence intervention|Before their physiotherapy appointment participants will be given four short questions to answer. Following this the participant will be assessed as normal. As part of the treatment they will be given an exercise programme as standard within physiotherapy. Following this participants will be asked to answer a further seven short questions; depending on the answers to both sets of questions, and on any discussion based on the answers, the physiotherapist will suggest one or more adherence approaches from a list of suggestions. These are; Review of exercise programme; Review of method of delivery; Cues or prompts; Discussion of barriers and problem solving; Motivational interviewing, Decision balance sheets; Behavioural contract; Goal setting review; Monitoring telephone call; Reminders.
15900808|NCT03643432|Behavioral|Usual Care|Participants in usual care will attend physiotherapy sessions as they would have had they not been in the trial.These sessions will include assessment and treatment approaches as given as part of routine care, without including the intervention described above for the 'exercise adherence intervention' arm
15900809|NCT03643419|Procedure|Laminectomy|According to the standard procedure of laminectomy for acute spinal cord injury
15900810|NCT03643419|Device|Spinal nerve laser therapeutic apparatus（Composed of 808-band fully automatic control laser device and implantable 360° scattering medical fiber）|According to the standard procedure of decompression of laminectomy for acute spinal cord injury, the patient in the Near Infrared Light Irradiation Group placed the implantable 360° scattering fiber laterally above the operation area at the end of the operation. Near infrared light irradiation is applied by spinal nerve laser therapeutic apparatus every day from the day after surgery, once a day for 60 minutes each time.
15900811|NCT03643406|Other|Mental Fatigue|modified stroop task
15900812|NCT03643406|Other|Control|documentary
15900813|NCT03643393|Procedure|perineal rectosigmoidectomy|In an Altemeier perineal rectosigmoidectomy, a full-thickness circumferential incision is made in the prolapsed rectum about 1-2 cm from the dentate line (see the image below). The hernia sac is entered, and the prolapse is delivered. The mesentery of the prolapsed bowel is serially ligated until no further redundant bowel can be pulled down. The bowel is transected and either hand-sewn to the distal anal canal or stapled with a circular stapler. Before anastomosis, some surgeons plicate the levator ani muscles anteriorly, which may help improve continence.
15900814|NCT03643380|Device|AHLeveeS System|AHLeveeS System for treatment of overactive bladder
15900923|NCT03642548|Drug|bifico|Patients in BIFICO group receive platinum-based doublet chemotherapy for first-line treatment chemotherapy plus Bifico.
15900815|NCT03643367|Drug|Sevoflurane|Included patients, randomized in experimental group, intravenous sedation will be interrupted and followed by a 4 hour sedation with the volatile anesthetic sevoflurane.
15900816|NCT03643367|Drug|Control Group|Included patients randomized in control group, intravenouse sedation is continued with propofol
15900817|NCT03643354|Diagnostic Test|Epley maneuver/Barbeque maneuver|Subjects will be rotated using the Rotundum Device to perform the previously described maneuvers Epley/Barbeque to evaluate the presence of BPPV.
15900818|NCT03643341|Behavioral|Family Healthy Living|Children aged 8-12 and at least one caregiver will meet for 10 weekly intervention sessions (1.5 hours per session), and 4 extra sessions to be chosen by families and intervention Leaders. During the intervention, participants will also have access to digital educational content that is supplementary to what is provided during the individual sessions. Four biweekly maintenance sessions will follow the main program.
15900819|NCT03643328|Biological|blood samples|Blood samples will be collected at inclusion, at 6 months and 12 months for hematological and immunological analyses.
15900820|NCT03643328|Biological|nasal swabs|Two nasal swabs will be collected at inclusion, at 6 months and 12 months for virology analyses.
15900821|NCT03643315|Behavioral|Exercise and Meal (EX)|30 minute acute bout of high intensity intermittent exercise followed by ad-libitum meal
15900822|NCT03643315|Behavioral|No-Exercise and Meal (NEX)|30 minute non-exercise period where participants will be watching a video/movie followed by ad-libitum meal
15900823|NCT03643302|Device|Version BF-1T26 electronic bronchoscope|Interventions involving the therapy of airway clearance and bronchoalveolar lavage by Version BF-1T26 electronic bronchoscope
15900824|NCT03643276|Drug|Blinatumomab|Experimental therapy in randomizations R-HR and R-MR
15900825|NCT03643276|Drug|Bortezomib|Experimental therapy in randomization R-eHR
15900826|NCT03643276|Drug|Cyclophosphamide|Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T
15900827|NCT03643276|Drug|Cytarabine|Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T and in the intensification block Myocet-FLA for patients with very high relapse risk
15900828|NCT03643276|Drug|Daunorubicin|Part of standard chemotherapy
15900829|NCT03643276|Drug|Myocet|Part of intensification block Myocet-FLA for patients with very high relapse risk
15900830|NCT03643276|Drug|Dexamethasone|Part of standard chemotherapy
15900831|NCT03643276|Drug|Doxorubicin|Part of standard chemotherapy
15900832|NCT03643276|Drug|Etoposide|Part of standard chemotherapy
15900833|NCT03643276|Drug|Fludarabine Phosphate|Part of intensification block Myocet-FLA for patients with very high relapse risk
15900834|NCT03643276|Drug|Ifosfamide|Part of standard chemotherapy
15900835|NCT03643276|Drug|6-Mercaptopurine|Part of standard chemotherapy and included in experimental treatment phase Protocol IB long in randomization R-T
15900836|NCT03643276|Drug|Methotrexate|Part of standard chemotherapy
15900837|NCT03643276|Drug|Pegaspargase|Part of standard chemotherapy
15900838|NCT03643276|Drug|Prednisolone|Part of standard chemotherapy
15900839|NCT03643276|Drug|Tioguanin|Part of standard chemotherapy
15900840|NCT03643276|Drug|Vincristine|Part of standard chemotherapy
15900841|NCT03643276|Drug|Vindesine|Part of standard chemotherapy
15900842|NCT03643276|Drug|Erwinase|Part of standard chemotherapy as substitute for PEG-L-Asparaginase in case of allergic reaction
15900843|NCT03643250|Other|Smaller Portion Size and Standard Appeal (non-divided plate)|Food with Smaller Portion Size and Standard Appeal on a non-divided plate
15900844|NCT03643250|Other|Smaller Portion Size and Enhanced Appeal (divided plate)|Food with Smaller Portion Size and Enhanced Appeal on a divided plate
15900845|NCT03643250|Other|Larger Portion Size and Standard Appeal (non-divided plate)|Food with Larger Portion Size and Standard Appeal on a non-divided plate
15900846|NCT03643250|Other|Larger Portion Size and Enhanced Appeal (divided plate)|Food with Larger Portion Size and Enhanced Appeal on a divided plate
15900847|NCT03643250|Other|Smaller Portion Size and Standard Appeal (divided plate)|Food with Smaller Portion Size and Standard Appeal on a divided plate
15900848|NCT03643237|Behavioral|Video game-based intervention|The intervention will be administered via an online graphic-adventure video game. It includes 3 components: depression prevention, cognitive stimulation, and healthy habits promotion. The depression prevention component will be adapted from an indicated depression prevention program based on the model by Lewinsohn, Hoberman, Teri, & Hautzinger, which is effective in short and long terms. The cognitive stimulation component is based on cognitive reserve and cerebral neuroplasticity. The healthy habits promotion component is based on the social learning and social cognitive theories. The App will allow participants to expand information, check progression, and receive reminders about homework
15900849|NCT03643237|Other|Control group|The active control group will have access to a platform of online therapeutically inactive information related to active aging.
15900851|NCT03643198|Drug|ANTIBIOTIC (METRONIDAZOLE AND CIPROFLOXACIN)|The control group will receive two types of placebo tablets that look identical to Ciprofloxacin and Metronidazole respectively, with similar doses and frequencies.
15900852|NCT03643198|Other|CONTROL|NO treatment
15900853|NCT03643159|Combination Product|Abilify MyCite - Digital Medicine System|The Abilify MyCite system is a drug-device combination product comprised of aripiprazole (an atypical antipsychotic) tablets embedded with a sensor that communicates with a patch (wearable sensor) and a medical software application with collected information (ingestion, mood, activity, rest) tracked and summarized for participants, healthcare providers, and potential caregivers. Abilify MyCite is intended to track drug ingestion and is indicated for the treatment of adults with schizophrenia (SCH), bipolar 1 disorder (BP1) (acute treatment of adults with manic and mixed episodes or maintenance treatment of adults), and adjunctive treatment of adults with major depressive disorder (MDD).
15900854|NCT03643159|Drug|Aripiprazole or other oral antipsychotics|For the treatment of adults with SCH, BP1 (acute treatment of adults with manic and mixed episodes or maintenance treatment of adults), and adjunctive treatment of adults with MDD.
15900924|NCT03642548|Drug|placebo|Patients in control group receive platinum-based doublet chemotherapy for first-line treatment chemotherapy plus Placebo.
15900855|NCT03643146|Behavioral|Lifestyle Management|Will use passive ubiquitous sensing through FitBit to 1)learn behavioral profiles of subjects who have pre-HTN/HTN and/or pre-diabetes /Diabetes 2) provide personalized recommendations through mobile based messaging app that will increase the likelihood of engaging in health diet/nutrition, physical activity and sleep practices
15900856|NCT03643146|Behavioral|Control Group|will receive standard medical care where research assistant will give pamphlets, with one size fits all recommendations for diet/nutrition, physical activity and sleep, to 10 subjects with comorbid HTN and T2D.
15900857|NCT03643133|Drug|Mifamurtide|48 doses overall over 36 weeks
15900858|NCT03643133|Combination Product|EI or M-API regimen depending on patient age|"M-API regimen:
~One course of high-dose Methotrexate (optional) followed by 5 courses of API, every 21 days
~EI regimen :
~5 course of EI, every 21 days"
15900859|NCT03643120|Other|Qualitative interview|Explorative study of gender dysphoria.
15900860|NCT03643107|Drug|Irofulven|"Irofulven will be administered as an intravenous dose of 0.45 mg/kg, over a 30-minute infusion period by venous access at day 1 and 8 of a three week cycle.
~Irofulven will be administered in combination with a daily dose of 10 mg orally administered prednisolone."
15900861|NCT03643107|Combination Product|Prednisolone 10 mg|"Irofulven will be administered as an intravenous dose of 0.45 mg/kg, over a 30-minute infusion period by venous access at day 1 and 8 of a three week cycle.
~Irofulven will be administered in combination with a daily dose of 10 mg orally administered prednisolone."
15900862|NCT03643094|Dietary Supplement|Golden Black Seed|1 capsule per day for 8 weeks.
15900863|NCT03643081|Device|"Use of the camera Fluobeam"|"Use of the camera Fluobeam to localize, visualize the parathyroid glands during a parathyroidectomy."
15900864|NCT03643068|Drug|KSP-QRH-E3-IRDye800 (Peptide 919288G), 0.6 mg|The investigational agent to be used in this study is KSP/QRH dimer: a fluorescently-labeled peptide dimer composed of a 14-amino acid sequence [Lys-Ser-Pro-Asn-Pro-Arg-Phe] and [Gln-Arg-His-Lys-Pro-Arg-Glu] attached via a PEG3, Lys and Cys linker [PEG3]2-Lys-Cys to a near-infrared fluorophore, IRDye800CW (0.6 mg dose).
15900865|NCT03643068|Drug|KSP-QRH-E3-IRDye800 (Peptide 919288G), 1.8 mg|The investigational agent to be used in this study is KSP/QRH dimer: a fluorescently-labeled peptide dimer composed of a 14-amino acid sequence [Lys-Ser-Pro-Asn-Pro-Arg-Phe] and [Gln-Arg-His-Lys-Pro-Arg-Glu] attached via a PEG3, Lys and Cys linker [PEG3]2-Lys-Cys to a near-infrared fluorophore, IRDye800CW (1.8 mg dose).
15900866|NCT03643055|Diagnostic Test|18F-fluorocholine PET/CT|18F-fluorocholine PET/CT imaging of the neck, mediastinum and whole body.
15900867|NCT03643042|Other|Transfusion|Transfusion with Hb maintain between 80 and 100g/L or Hb maintain between 100 and 120g/L
15900868|NCT03643029|Device|Video-laryngoscopy following SAD insertion|Following insertion of a supraglottic airway device (SAD), the placement and performance tests are carried out. If the tests are successful, a video-laryngoscopy will be performed to confirm the placement of the SAD in the hypopharynx.
15900869|NCT03643016|Other|Surgical strategy based on a software|Surgical strategy décision based on a software
15900870|NCT03643003|Behavioral|Music therapy|"Music therapy consists of live singing of participant-preferred music, with guitar accompaniment, by a board-certified music therapist (i.e., MT-BC), following a protocol regarding how to manipulate the music in real time per participant responses. Dosage: participants engage in a small-group (3-6 participants) session at their nursing home, 3 times per week, across 2 consecutive weeks. Each session lasts 25 minutes and occurs in the afternoon."
15900871|NCT03643003|Behavioral|Non-Music Verbal Interaction (Placebo)|"Non-music verbal interaction consists of conversation of participants' interests, without music, by a board-certified music therapist, following a protocol regarding how to respond verbally in real time per participant responses. Dosage is the same as for music therapy: participants engage in a small-group (3-6 participants) session at their nursing home, 3 times per week, across 2 consecutive weeks. Each session lasts 25 minutes and occurs in the afternoon."
15900872|NCT03642990|Drug|Nicotinamide Riboside|Capsule
15900873|NCT03642977|Diagnostic Test|Real time PCR and RT-PCR for DNA and RNA viral species|Qualitative and quantitative real time PCR and RT-PCR assays will be performed on hematopoietic stem cell transplant recipients' plasma samples collected at five specific time points over a one-year period after transplantation (the day of transplantation (D0), 30 days (D30), 3 months (M3), 6 months (M6) and one year (Y1) after transplantation), for the screening of a selection of at least 21 DNA and RNA viruses (belonging to the Herpesviridae, Polyomaviridae, Adenoviridae, Parvoviridae, Anelloviridae, Picornaviridae and Flaviviridae families).
15900874|NCT03642964|Drug|CTC-501|pramipexole IR, given with ondansetron
15900875|NCT03642951|Device|Active Treatment|The study patients will be randomly assigned to two groups, each consisting of 10 patients: Group A - patients stimulated by devices marked A; Group B - patients stimulated by devices marked B. Since the devices used for actual and sham stimulation (placebo control) are similar in all respects including external appearance and the sound produced while activated, the technician(s), investigators and the patients will be completely blind to whether actual or sham stimuli are being delivered, i.e. whether Group A or Group B patients are receiving the actual stimuli. Indeed, both devices marked A&B could be used to deliver either type of stimuli. Only the person who constructed the devices will know which is which. Therefore, this study will be a truly randomized double-blinded placebo-controlled clinical trial. In case of emergency, un-blinding of the device will be available to the study team via a sealed envelope, stored with the study documents, separate from the subjects study files.
15900876|NCT03642951|Device|Sham Treatment|The study patients will be randomly assigned to two groups, each consisting of 10 patients: Group A - patients stimulated by devices marked A; Group B - patients stimulated by devices marked B. Since the devices used for actual and sham stimulation (placebo control) are similar in all respects including external appearance and the sound produced while activated, the technician(s), investigators and the patients will be completely blind to whether actual or sham stimuli are being delivered, i.e. whether Group A or Group B patients are receiving the actual stimuli. Indeed, both devices marked A&B could be used to deliver either type of stimuli. Only the person who constructed the devices will know which is which. Therefore, this study will be a truly randomized double-blinded placebo-controlled clinical trial. In case of emergency, un-blinding of the device will be available to the study team via a sealed envelope, stored with the study documents, separate from the subjects study files.
15900877|NCT03642938|Behavioral|Walking Exercise|Exercise groups will perform moderate intensity treadmill walking at a speed of 3.5 mph at a 0% incline for 30 minutes.
15900879|NCT03642925|Dietary Supplement|Meal replacement diet|Obese subjects were requested to replace two meals/day (breakfast and lunch or dinner) by balanced nutritional meal replacement diet (equal to 240 kcal) for 8 weeks with one regular meal and make sure the daily target calorie limit should be less than 1500 kcal/day for men and 1200 kcal/day for women.
15900880|NCT03642886|Behavioral|Prescribed Detraining|Detraining is the deliberate act of reducing volume of exercise to observe subsequent changes in cardiac indices over time or the partial or complete loss of training of induced anatomical, physiological and performance adaptions. Detraining is primarily employed as a diagnostic tool to help differentiate Athletes' heart from cardiac pathology.
15900881|NCT03642873|Drug|Humibid®|Humibid® 1200 mg (single extended release) tablet
15900882|NCT03642873|Drug|Hydrocodone Bitartrate|Hydrocodone Bitartrate (3.33 mg q4h X 3)
15900883|NCT03642873|Drug|Humibid® and Hydrocodone Bitartrate tablet|Humibid® 1200 mg (single extended release) tablet and Hydrocodone bitartrate (3.33 mg q4h X 3)
15900884|NCT03642860|Drug|Triheptanoin|Daily treatment with Triheptanoin oil for 14 days (7 days titration period in addition to 7 days full dose period with 1g/kg/day).
15900885|NCT03642860|Drug|Placebo Oil|Daily treatment with Safflower oil for 14 days (7 days titration period in addition to 7 days full dose period with 1g/kg/day).
15900886|NCT03642847|Biological|Prevnar 13|13 valent Pneumococcal Conjugate
15900887|NCT03642847|Biological|multivalent pneumococcal conjugate formulation 1|multivalent pneumococcal conjugate formulation 1
15900888|NCT03642847|Biological|multivalent pneumococcal conjugate formulation 2|multivalent pneumococcal conjugate formulation 2
15900889|NCT03642834|Drug|ICP-105|25mg, 100mg capsule
15900890|NCT03642821|Device|intracranial aneurysm coiling|endovascular treatment of intracranial aneurysm by coiling procedure using OPTIMA coils system
15900891|NCT03642808|Other|rehabilitation program|Availibility of patients to complete a rehabilitation program during 8 weeks and to come back 4 times for a careful medical examination
15900892|NCT03642795|Other|Questionnaire|Patients are asked to complete several questionnaires
15900893|NCT03642782|Device|Electroretinogram Pattern (Diopsys® NOVA System)|it's an additional examination that extends the duration of the ophthalmological consultation by 30 minutes
15900894|NCT03642769|Other|Fluid administration|Fluid administration of bolus and maintenance fluids
15900895|NCT03642756|Device|different intra-arterial catheter size|in placebo group, patients were cannulated with 20 gauge intra-arterial catheter. In experiment groups, patients were cannulated with 22 gauge or 24 gauge intra-arterial catheter.
15900896|NCT03642743|Other|postoperative follow up appointment|Comparison of two and six week postoperative follow up versus a six week postoperative follow up alone
15900897|NCT03642730|Device|TransThoracic Echocardiography imaging|ultrasound scanning
15900898|NCT03642717|Drug|JARDIANCE DUO®|empagliflozin and metformin
15900899|NCT03642704|Drug|Reinforced preventive ARV therapy|"If the mother is HIV-1 or HIV 1/2 infected:
~zidovudine / laminvudine (60/30 mg), ¼ cp morning and evening orally for 12 weeks.
~nevirapine: 15mg/OD if weight ≥ 2500g / 10mg/OD if weight = 2000-2499g / 2mg/kg/OD if weight < 2000g for 12 weeks in case of HIV-1 infection. After 6 weeks, nevirapine will increase at 20mg/OD
~If the mother is HIV-2 infected:
~- zidovudine / laminvudine (60/30 mg), ¼ cp morning and evening orally for 12 weeks."
15900900|NCT03642691|Biological|Ryplazim|Plasminogen IV replacement therapy
15900901|NCT03642678|Dietary Supplement|ONS|High-risk patients identified by prediction model in study group are intervened by pre-defined intervention protocol, which include oral nutrition supply, infection prevention, bp control and improving of dialysis therapy options and so on.
15900902|NCT03642665|Drug|Natural cycle|no medication
15900903|NCT03642665|Drug|Estradiol Valerate|Oestradiol valerate (Progynova, Bayer, Germany) 6mg daily will be given from day 2 of the cycle. The dose of Progynova is increased to 8mg daily if the endometrial thickness is less than 7mm after 7-10 days of Progynova use. Progynova will be discontinued the day of the pregnancy test in case of a negative result. In case of a pregnancy, Progynova will be continued until 12 weeks or until diagnosis of a non-viable pregnancy.
15900904|NCT03642665|Drug|Micronized progesterone|Micronized progesterone (Utrogestan, Besins, Belgium) 200 mg vaginally three times daily is started as soon as the endometrial thickness is 7 mm. Utrogestan will be discontinued the day of the pregnancy test in case of a negative result. In case of a pregnancy, Utrogestan will be continued until 12 weeks or until diagnosis of a non-viable pregnancy.
15900905|NCT03642652|Behavioral|SMS|Text reminders to mobile telephone
15900906|NCT03642639|Device|MICRUSFRAME and GALAXY coils|MICRUSFRAME and GALAXY Coils
15900907|NCT03642626|Drug|KYMRIAH|FDA approved CD19-directed genetically modified autologous T cell immunotherapy comprised of autologous T cells
15900908|NCT03642626|Drug|YESCARTA|CD19-directed genetically modified autologous T cell immunotherapy
15900909|NCT03642626|Drug|Fludarabine 30mg/m2 4 doses|30 mg/m2 IV daily for 4 doses
15900910|NCT03642626|Drug|Cyclophosphamide 500 mg/m2; 2 doses|500 mg/m2 IV daily for 2 doses starting with the first dose of fludarabine
15900911|NCT03642626|Drug|Fludarabine 30mg/m2 3 doses|30 mg/m2 IV daily for 3 doses
15900912|NCT03642626|Drug|Cyclophosphamide 500 mg/m2; 3 doses|500 mg/m2 IV daily for 3 doses starting with the first dose of fludarabine
15900913|NCT03642626|Drug|Fludarabine 25mg/m2 3 days|25 mg/m2 i.v. daily for 3 days
15900914|NCT03642626|Drug|Cyclophosphamide 250 mg/m2; 3 days|250 mg/m2 IV daily for 3 days starting with the first dose of fludarabine
15900915|NCT03642626|Drug|Tecartus|TECARTUS is a CD19-directed genetically modified autologous T cell immunotherapy, binds to CD19-expressing cancer cells and normal B cells
15900916|NCT03642600|Dietary Supplement|dietary advice plus myo-inositol and folic acid|dietary advice and lifestyle interventions and myo-inositol
15900917|NCT03642600|Drug|dietary advice plus Liraglutide Pen Injector|dietary advice and lifestyle interventions and liraglutide pen injector
15900918|NCT03642587|Other|There is no intervention in this study.|There is no intervention in this study.
15900919|NCT03642574|Procedure|DNA methylation level|Embryo with methylation level closest to the optimal level (from one couple patients) is the one for embryonic transfer to uterus
15900920|NCT03642574|Procedure|blastocyst biopsy and sequencing|All blastocysts will be biopsied on trophectoderm, sequenced with next-generation sequencing (NGS). Euploidy will transferred one by one according to morphologic score.
15900925|NCT03642535|Drug|ALA|In all face treatment group, a 1-mm thick layer of 10% ALA was applied to the all face; In AK lesion treatment group, a 1-mm thick layer of 10% ALA was applied to the lesion and to 5 mm of surrounding healthy tissue. And Vehicle control cream was applied to the non-lesion area.
15900926|NCT03642522|Device|repetitive transcranial magnetic stimulation|rTMS is a Health-Canada- and FDA-approved treatment for treatment-resistant depression (TRD), using focused magnetic field pulses to stimulate brain regions involved in emotion regulation, safely and non-invasively. rTMS can be applied at varying discharge frequencies which have differential effects on cortical excitability. At a low frequency (≤ 1Hz), rTMS reduces cortical excitability, while at frequencies greater than 1 Hz, rTMS facilitates cortical excitability3. In MDD, either high- frequency rTMS (HF-rTMS) applied over the left dorsolateral prefrontal cortex (DLPFC) or low- frequency rTMS (LF-rTMS) applied over the right DLPFC have similar efficacy. This study utilizes low frequency rTMS to the right DLPFC.
15900927|NCT03642509|Device|Left atrial appendage occlusion|Interventional left atrial appendage occlusion with the Amulet or Watchman device
15900928|NCT03642509|Drug|NOAC|Medical treatment arm. Patients will be treated with one of the available NOAC drugs; Apixaban, Dabigatran, Edoxaban or Rivaroxaban. The specific drug and dose is at the discretion of the treating physician.
15900929|NCT03642496|Biological|Low dose ET019002- T Cells|ET019002- T Cells are autologous T cells transduced expressing a novel anti-CD19 (ET019002) chimeric antigen receptor,and are administered by intravenous infusion with the dose of 0.75×10*6/kg.
15900930|NCT03642496|Biological|Middle dose ET019002- T Cells|ET019002- T Cells are autologous T cells transduced expressing a novel anti-CD19 (ET019002) chimeric antigen receptor,and are administered by intravenous infusion with the dose of 1.5×10*6/kg.
15900931|NCT03642496|Biological|High dose ET019002- T Cells|ET019002- T Cells are autologous T cells transduced expressing a novel anti-CD19 (ET019002) chimeric antigen receptor,and are administered by intravenous infusion with the dose of 3.0×10*6/kg.
15900932|NCT03642457|Drug|Bupivacaine|20 cc 0.5%
15900933|NCT03642457|Drug|Bupivacaine liposome|133mg liposomal bupivacaine
15900934|NCT03642444|Device|Cane|Assistive walking device
15900935|NCT03642444|Device|Elasticated worn orthotic-garment|Assistive walking device -elasticated worn orthotic garment
15900936|NCT03642405|Diagnostic Test|Electrocardiogram examination|12-lead ECG monitored by Holter
15900937|NCT03642405|Diagnostic Test|Echocardiography|Echocardiography in accordance to Danish Society of Cardiology
15900938|NCT03642405|Procedure|Blood Samples|Blood Samples include, Genetic analysis, serum-Methylphenidate, serum-Citalopram. Sodium, Potassium, Magnesium, Calcium, Chloride, White-Blood-Count, Hemoglobin, C-reactive-Protein, Creatinine, Carbamide, aspartate aminotransferase (ASAT), alanine aminotransferase (ALAT), Glucose and pro-brain natriuretic peptide (Pro-BNP).
15900939|NCT03642405|Behavioral|Questionnaire|Questionnaire regarding patients quality of life
15900940|NCT03642392|Other|Identification and treatment of early tendinopathy|Participants receive initial guidance about load reduction when tendinopathy
15900941|NCT03642366|Other|Dornier Aries2 LiST Device + 5mg Tadalafil (1)|Patients will receive shockwave treatments (12 sessions for all subjects, 5000 shockwaves at each session, at energy level 7), three times a week (total of 4 weeks) without treatment interval. Starting at first LiST session and finishing at the final week of LiST sessions, subjects will receive Tadalafil 5mg for 4 weeks daily. Total treatment period = 4 weeks.
15900942|NCT03642366|Other|Dornier Aries2 LiST Device + 5mg Tadalafil (2)|Patients will receive shockwave treatments (12 sessions for all subjects, 5000 shockwaves at each session, at energy level 7), three times a week (total of 4 weeks) without treatment interval. Starting at first LiST session and finishing at the final week of LiST sessions, subjects will receive Tadalafil 5mg for 4 weeks daily. Total treatment period = 4 weeks.
15900943|NCT03642366|Other|Sham LiST Device + 5mg Tadalafil|Patients will receive sham shockwave treatment (12 sessions for all subjects, 5000 shockwaves at each session, at energy level 7)using a sham probe identical to active probes, three times a week (total of 4 weeks) without treatment interval. Starting at first LiST session and finishing at the final week of LiST sessions, subjects will receive Tadalafil 5mg for 4 weeks daily. Total treatment period = 4 weeks. The IIEF-ED domain will be evaluated at Visit 1 and, consequently, at baseline and all follow up visits together with the SEP diaries.
15900944|NCT03642353|Drug|Triclosan|Children will be included in a cross-over study with control of plaque using Triclosan/placebo toothpaste for 4 months. Each child will be tested for placebo toothpaste for 45 days and for Triclosan toothpaste for more 45 days. At the beginning of each test, they will be included in a washout period with placebo toothpaste for 15 days.
15900945|NCT03642353|Drug|Placebo|Children will be included in a cross-over study with control of plaque using Triclosan/placebo toothpaste for 4 months. Each child will be tested for placebo toothpaste for 45 days and for Triclosan toothpaste for more 45 days. At the beginning of each test, they will be included in a washout period with placebo toothpaste for 15 days.
15900946|NCT03642327|Behavioral|Experimental: Maintenance of Certification (MOC)|MOC training will lead to more positive attitudes, comfort level and competence in addressing risk factors for Child Maltreatment.
15900947|NCT03642327|Other|Independent online training (IND)|IND refers to practitioners Independently doing the online training.
15900948|NCT03642314|Diagnostic Test|HIV self test kit|HIVST receptor will be invited to priority access to PrEP sites
15900949|NCT03642288|Drug|Gastrografin|Patients with CRE-induced SBO or ASBO both received GG challenge.
15900950|NCT03642275|Behavioral|iCardia4HF|Participants in the intervention group will receive the Heart Failure Health Storylines mobile app, three connected health devices that interface with the app (Fitbit Charge 2 activity tracker, and FDA-approved Nokia BP monitor and Cardio Body weight scale), and a program of tailored self-care text-messages, in addition to usual care. Participants will be asked to use the app and devices to record and self-monitor their daily symptoms, blood pressure, weight, and physical activity.
15900951|NCT03642262|Drug|Mucinex®|Mucinex® 600 mg single dose ER bi-layer tablet
15900952|NCT03642249|Behavioral|OSCEs|Scenario-based education intervention, including objective structured clinical examinations (OSCEs)
15900953|NCT03642249|Behavioral|Lecture|Face-to-face Education using Delirium Care Flip Chart
15900954|NCT03642249|Behavioral|E-learning|Including 7 parts of delirium care video
15901556|NCT03637335|Combination Product|irradiation + placebo|30 Gy en 10 fractions de 3 Gy + 10 injections of placebo
15900955|NCT03642236|Drug|Ibrutinib|Ibrutinib 420mg day -3 to d14 combining with chemotherapy with/without sorafenib based on whether the patients are naive to sorafenib before relapse.
15900956|NCT03642223|Other|Stable iron isotopes|Participants have to consume a test meal containing stable iron isotopes in order to determine iron absorption
15900957|NCT03642210|Combination Product|Levonorgestrel 52 mg intrauterine system|Levonorgestrel 52 mg intrauterine system
15900958|NCT03642197|Behavioral|Attendance|The SFA and PA arms will be instructed to attend pre-surgery classes and clinical visits with the patients.
15900959|NCT03642184|Drug|Empagliflozin|Dosage adjustment based on glucose targets . Once daily
15900960|NCT03642184|Drug|Linagliptin|Dosage adjustment based on glucose targets. Once daily
15900961|NCT03642158|Device|repetitive Transcranial Magnetic Stimulation|repetitive Transcranial Magnetic Stimulation (rTMS) utilizes a magnetic coil of wire to non-invasively and painlessly activate small sections of the brain through the skull.
15900962|NCT03642145|Drug|Deflazacort|Deflazacort tablets will be administered as per schedule and dose specified in respective arms.
15900963|NCT03642132|Drug|Chemotherapy + avelumab followed by avelumab + talazoparib|"Chemotherapy Period Paclitaxel Carboplatin Avelumab
~Maintenance Period Avelumab Talazoparib"
15900964|NCT03642132|Drug|Chemotherapy followed by talazoparib maintenance|"Chemotherapy Period Paclitaxel Carboplatin
~Maintenance Period Talazoparib"
15900965|NCT03642132|Drug|Chemotherapy + bevacizumab followed by bevacizumab|"Chemotherapy Period Paclitaxel Carboplatin Bevacizumab
~Maintenance Period Bevacizumab"
15900966|NCT03642119|Device|iButton®|Women with frequently reported hot flashes will be undergo both real world (ambulatory; field tests) and controlled (laboratory) assessments to validate the iButton® as an objective method to assess hot flash dynamics and incidence.
15900968|NCT03642093|Combination Product|Nutritional Intervention|Nutritional Supplementation for all subjects and Pancreatic Enzyme Replacement Therapy only for subjects with Exocrine Pancreatic Insufficiency
15900969|NCT03642093|Behavioral|Physical Activity Intervention|Walking and Inspiratory Muscle Training
15900970|NCT03642067|Drug|Nivolumab|Patients will receive treatment every 28 days for up to 2 years. Nivolumab will be administered IV on day 1 (28 day cycle).
15900971|NCT03642067|Drug|Relatlimab|Patients will receive treatment every 28 days up to 2 years. Relatlimab will be administered IV on day 1 (28 day cycle).
15900972|NCT03642067|Drug|Nivolumab|Patients will receive treatment every 28 days for up to 2 years. Nivolumab will be administered IV on day 1 (28 day cycle).
15900973|NCT03642067|Drug|Relatlimab|Patients will receive treatment every 28 days up to 2 years. Relatlimab will be administered IV on day 1 (28 day cycle).
15900974|NCT03642041|Behavioral|smoking|smoking behavior
15900975|NCT03642028|Drug|Suvorexant|Suvorexant, a dual orexin receptor antagonist, is the first in a new class of drugs with great promise of addressing insomnia in Veterans with PTSD. Suvorexant targets the orexin neuropeptide system and has been shown to be highly successful in treating insomnia.
15900976|NCT03642028|Other|Placebo|Visibly matched, equally weighted placebo tablets. In addition to matching in appearance and weight, they will have identical packaging and labeling as randomized, blinded study medication.
15900977|NCT03642015|Behavioral|Music listening|listening the music 15 min
15900978|NCT03642002|Other|Toning|"Music therapist will begin gentle breathing and toning on a descending Ah vowel to stimulate vibration in the chest and increase awareness of the breath. The patient will be encouraged to join the music therapist as is comfortable"
15900979|NCT03642002|Other|Ocean drum & SOK melody|Music therapist will introduce ocean drum to mimic breathing sounds and will hum the melody of Song of Kin to begin entrainment process. Patient will be invited to join the music therapist in humming as is comfortable
15900980|NCT03642002|Other|SOK|Music therapist will introduce sung lyric content of Song of Kin accompanied on guitar. Patient will be invited to sing with music therapist as is comfortable.
15900981|NCT03642002|Behavioral|Process|Music therapist will process patient experience and provide psycho-education on strategies for using music to promote comfort and enhance breath.
15900982|NCT03642002|Other|Holding Harmonic Container|"Music therapist will provide a holding harmonic container of IM7 - IVM7 and will improvise a repeating melody on ah based on the ambient sounds in the patient's immediate environment"
15900983|NCT03641989|Other|Plaque disclosing toothpaste|Plaque identifying toothpaste with a FDA-registered seed-extract dye (Annatto (Bixa Orellana)) and FD&C Blue No. 1.
15900984|NCT03641989|Other|Non-plaque disclosing toothpaste|Toothpaste that does not contain the FDA-registered seed-extract dye (Annatto (Bixa Orellana)) and FD&C Blue No. 1.
15900985|NCT03641976|Drug|A-FOLFOXIRI|"Arm I (A-FOLFOXIRI)
~Biological: bevacizumab Given IV
~Drug: fluorouracil Given IV
~Drug: irinotecan hydrochloride Given IV
~Drug: leucovorin calcium Given IV
~Drug: oxaliplatin Given IV"
15900986|NCT03641976|Drug|Arm II (A-FOLFOX/A-FOLFIRI)|"Arm II (A-FOLFOX/A-FOLFIRI)
~Biological: bevacizumab Given IV
~Drug: fluorouracil Given IV
~Drug: irinotecan hydrochloride Given IV
~Drug: leucovorin calcium Given IV"
15900987|NCT03641963|Device|Vittamed 205 Non-invasive intracranial pressure (ICP) meter|Non-Invasive intracranial pressure measurement
15900988|NCT03641950|Drug|Botulinum toxin type A|Recommended initial dose to be intra-muscularly injected to the medial and contralateral pretarsal orbicularis oculi of the upper eyelid and the contralateral pretarsal orbicularis oculi of the lower eyelid is 1.25-2.5U (0.05ml ~ 0.1ml per site).
15900989|NCT03641924|Behavioral|Cognitive Processing Therapy|Cognitive Processing Therapy is an evidence-based psychotherapy for PTSD.
15901008|NCT03641768|Device|Radioligand 18F-AV-1451|At the Duke University PET Center you will be in a quiet dimly lit space with only ambient room sound, with your eyes open and ears unplugged. Your safety will be monitored by a physician and nurse. 18F-florbetapir will be administered to you as a bolus injection through a peripheral vein followed by a flush and 10 minute continuous brain PET imaging will begin 50 minutes post-injection.
15900990|NCT03641898|Procedure|FFR-guided PCI|After the angiographic screening for lesions with 40%-90% diameter stenosis, FFR will be performed according to standard protocol using the s5 console and PrimeWire Prestige PLUS coronary pressure wire (Volcano Corporation, San Diego, California). FFR is calculated as the ratio of mean distal intracoronary pressure measured by the pressure wire, and the mean arterial pressure measured through the coronary guiding catheter. An FFR ≤0.8 or >90% diameter stenosis should result in a treatment decision for revascularization by PCI and lesions with FFR >0.80 are defined as FNLs and should result in deferral of PCI.
15900991|NCT03641898|Diagnostic Test|Intravascular ultrasound|After the successful FFR-guided PCI, IVUS will be performed in all FNLs with the ultrasound Imaging Catheter Atlantis™ SR Pro (40 MHz, mechanical-type transducer, 3.2 F, Boston Scientific Corporation, Natick, MA, USA). Quantitative analyses of grayscale IVUS include contouring external elastic membrane (EEM) and luminal borders and the measurement of EEM cross-sectional area (CSA), luminal CSA, plaque and media CSA, plaque burdenand remodeling index. Virtual assessment of plaque is performed with iMap software (QIvus 2.0; Medis Medical Imaging Systems, Leiden, The Netherlands). Plaque components are categorized as dense calcium, necrotic core, fibrofatty, and fibrous tissue and reported as absolute area and proportion of total plaque area.
15900992|NCT03641885|Behavioral|mothers and adolescents|The intervention package will be sent to mothers and adolescents via Telegram social media. It contains behavior change techniques targeting outcome expectancy, self-efficacy, action planning, coping planning, and self-monitoring. There will be 3 assessment points in time, baselines, 1 month and six months after interventions.
15900993|NCT03641885|Behavioral|adolescents|The intervention package will be sent to only adolescents via Telegram social media. It contains behavior change techniques targeting outcome expectancy, self-efficacy, action planning, coping planning, and self-monitoring. There will be 3 assessment points in time, baselines, 1 month and six months after interventions.
15900994|NCT03641885|Behavioral|active control|The active control group receives an information sheet regarding recommendations on oral health behavior via telegram. There will be 3 assessment points in time, with 1 month and six months in between.
15900995|NCT03641872|Other|Standary therapy|Standary therapy for chronic liver disease with ALI and/or AD
15900996|NCT03641859|Device|virtual reality|"The virtual reality headset can be used for 45 minutes with the need to pause for 5 minutes if the gesture lasts longer. The VR sequence will be complete when the end of the programmed time is reached to preserve the patient's immersion. The patient will be able to see the final sequence at the end of the gesture in order to get used to the real world again. The programs and their durations will be adjusted to the duration of the gesture concerned. Regarding the pain, anxiety and satisfaction visual analogue scales, they will be performed just after the removal of the VR helmet.
~Virtual reality videos are from Healthy Mind® software. The videos are contemplative with three kinds of relaxing landscapes accompanied by a sound universe specifically composed to relax the patient. The patient can choose one of three interactive worlds (an Asian garden, a forest or a mountain)."
15900997|NCT03641846|Other|DornierAries2 LiST device + 5 mg Tadalafil|All patients will receive shockwave treatment (6 sessions for all subjects, 5000 shockwaves at each session, at energy level 7), twice per week (total of 3 weeks) without treatment interval. Starting at first LiST session and finishing one week after final LiST session, subjects will receive for 4 weeks daily Tadalafil 5mg. Total treatment period = 4 weeks
15900998|NCT03641846|Other|DornierAries2 LiST device + Placebo Pill|All patients will receive shockwave treatment (6 sessions for all subjects, 5000 shockwaves at each session, at energy level 7), twice per week (total of 3 weeks) without treatment interval. Starting at first LiST session and finishing one week after final LiST session, subjects will receive for 4 weeks daily Placebo pills. Total treatment period = 4 weeks.
15900999|NCT03641833|Diagnostic Test|blood sample for brain biomarkers|Transcranial Doppler will be performed to evaluate a.cerebri media blood flow speed during surgery.
15901000|NCT03641807|Other|Acupuncture|Bilateral BL23, BL33, BL35 and SP6 will be inserted using Hwato-brand disposable acupuncture needles. With patients prone, after routine sterilization, bilateralBL33 will be inserted to a depth of 50 to 60mm with a 30° to 45° angle in an inferomedial direction using needles (0.30mm in diameter, 75mm in length). Bilateral BL35 will be inserted to a depth of 50 to 60mm with a slightly superolateral direction using needles (0.30mm in diameter, 75mm in length). BL23 and SP6 will be inserted vertically to a depth of 25 to 30mm using needles (0.30mm in diameter, 40mm in length). Manipulation of the needles by lifting and thrusting combined with twirling and rotating evenly will be performed until deqi occurs, defined as a sensation of soreness, numbness, heaviness, and ache. Manipulations will be applied every 10minutes and each session will last for 30minutes.
15901001|NCT03641807|Other|Sham acupuncture|Bilateral sham BL 23, BL 33, BL 35 (15mmto BL23, BL33, and BL35) and SP6 (10mmto SP6) will be inserted by needles (0.20mm in diameter, 25mm in length) to a depth of 2 to 3mm without manipulation.
15901002|NCT03641794|Drug|DN1406131|IDO1 and TDO2 inhibitor
15901003|NCT03641794|Drug|Placebo|Placebo
15901004|NCT03641781|Other|isometric strength training and isokinetic strength training|"Isokinetic strength program included strength training at 5 different velocities from slow to fast. Participants were trained on speed of 30°/sec, 90°/sec, 150°/sec, 210°/sec and 270°/sec. Flexion and extension movements were completed with 5 repetitions at each speed.
~Participants of isometric strength training group performed isometric contractions at 30°, 45° and 60° of knee flexion with five repetitions at each angle for both hamstring and quadriceps."
15901005|NCT03641768|Device|MRI|You will be asked to undergo a scan of your brain called an MRI. The MRI scan can measure the functioning of your brain.
15901006|NCT03641768|Device|PET|You will be asked to undergo a scan of brain called a positron emission tomography (PET) scan. The PET scan is a test that uses radioactive glucose (sugar) and a computer to create images of how your brain is functioning. Abnormal cells in the body use glucose at a different rate than normal cells and this allows the scanner to create a detailed picture of how your body is working.
15901007|NCT03641768|Device|18F-Florbetapir|At the Duke University PET Center you will be in a quiet dimly lit space with only ambient room sound, with your eyes open and ears unplugged. Your safety will be monitored by a physician and nurse. 18F-florbetapir will be administered to you as a bolus injection through a peripheral vein followed by a flush and 10 minute continuous brain PET imaging will begin 50 minutes post-injection.
15901009|NCT03641755|Drug|Sapacitabine|Sapacitabine may help to stop the growth of some types of cancers
15901653|NCT03636542|Drug|liposomal bupivacaine|Experimental
15901010|NCT03641755|Drug|Olaparib|Olaparib is an inhibitor of PARP (poly [adenosine diphosphate-ribose] polymerase), which means that it stops PARP from working
15901011|NCT03641729|Other|individualized exercise training program|The exercise training program was performed once daily, included 2- to 5-minute warm-up session (stretching, coordination and balance exercises), 10 to 20 minutes of moderate-intensity aerobic exercise using a cycle ergometer, 3 - to 5-sets to ten repetitions of sit-to-stand exercises with a 1-minute rest interval between each set. A cool-down period of 2- to 5-minutes of stretching and breathing exercises was delivered at the end of the exercise session. The aerobic training target zone was set at 50% to 70% of heart rate (HR) reserve.
15901012|NCT03641716|Behavioral|Mealtime PREP Intervention|Each session will include didactic elements and skills training along with skills practice and feedback. Parents will learn to build structured mealtime routines, manage child mealtime behavior, and incorporate exploration and play into routines.
15901013|NCT03641703|Biological|FLT180a|FLT180a is a replication-incompetent adeno-associated viral vector. The vector is composed of a DNA vector genome encapsidated in an adeno-associated virus derived protein capsid. The expression cassette contains DNA encoding Factor IX.
15901014|NCT03641690|Other|Empirical antimicrobial therapy|All patients with pulmonary symptoms received empirical antimicrobial therapy with ceftriaxone and rovamycin or levofloxacin on admission and this was subsequently adapted to any documented bacterial infection if positive.
15901015|NCT03641677|Device|Centralized Lung Evaluation System|Assessment of allograft lung for transplant suitability
15901016|NCT03641677|Procedure|Lung Transplant|Orthotopic single or double lung transplantation.
15901017|NCT03641664|Behavioral|Family Centered Treatment|Family Centered Treatment® (FCT) is a promising practice for providing home-based services to families at-risk for their children being removed from home.
15901018|NCT03641664|Behavioral|Level II or Level III Out of Home Placement|Residential care for children with emotional, behavioral, and/or mental health in North Carolina who have experienced a level of dysfunction that makes it impossible to function at an age appropriate level in their own homes or in a lower level of care. These services can be provided in a variety of locations from urban to rural, from facility based to community based and from public sector to private sector. This service provides a structured and supervised environment for the acquisition of skills necessary to enable the child to improve level of functioning to achieve and/or to maintain the most realistic level of independent function where earlier treatment gains are somewhat fragile and the child is subject to regression.
15901019|NCT03641651|Other|Rehabilitation technology|"Series of tailored rehabilitative training with the use of new technology which provide feedback and allow for a targeted and intensive and dense training.
~With supervision based on patients preconditions and therapy device (e.g. patient/ therapist ratio= 3/1).
~A training series lasts four weeks and comprises 3-5 training-days per week. Maximum training break of 7 days.
~Five sessions of training with duration of 45 min per session, and up to four hours each day are foreseen.
~The training can take place in an outpatient or inpatient setting.
~Training will be organized in individual one-to-one or group session"
15901020|NCT03641625|Device|Muscular tissue oxygen saturation guided care|Muscular tissue oxygen saturation monitored at flank and arm will be maintained > 70% (absolute measurement) and > baseline throughout the entire procedure.
15901021|NCT03641612|Other|one shape|canal fluid sample before and after root canal instrumentation
15901022|NCT03641612|Other|protaper next|canal fluid sample before and after root canal instrumentation
15901023|NCT03641599|Diagnostic Test|echocardiography|echocardiographic assessment of the RV and LV systolic function
15901024|NCT03641586|Drug|BGB-283|
15901025|NCT03641573|Drug|[14C] ASN002|[14C] ASN002
15901026|NCT03641560|Drug|Enzalutamide|Enzalutamide will be administered orally
15901027|NCT03641560|Drug|Androgen deprivation therapy (ADT)|All participants will be required to maintain ADT during study treatment, either using a Gonadotropin Releasing Hormone (GnRH) agonist/antagonist or having a history of bilateral orchiectomy
15901028|NCT03641547|Drug|M6620|M6620 is an unlicensed small molecule ATR inhibitor which can be used in combination with DNA damaging agents. In pre-clinical models it has substantial activity when given with DNA damaging drugs or ionising radiation. The clinical agent (M6620) is currently studied in a phase I trial in Oxford and other centres in combination with gemcitabine, cisplatin, gemcitabine/cisplatin and cisplatin/etoposide.
15901029|NCT03641547|Drug|Cisplatin|Cisplatin is a platinum based chemotherapy drug licensed to treat a number of different types of cancer. Cisplatin use is not considered standard practice in Stage A2 & B, therefore Cisplatin is considered an investigational medicinal product for the purpose of this trial.
15901030|NCT03641547|Drug|Capecitabine|Capecitabine is a chemotherapy drug licensed to treat a number of different types of cancer, it is a noncytotoxic pre-cursor of the cytotoxic 5-fluourouracil. Capecitabine use is not considered standard practice in Stage A2 & B, therefore Capecitabine is considered an investigational medicinal product for the purpose of this trial.
15901031|NCT03641547|Radiation|Radiotherapy|Stage A1 uses palliative radiotherapy. Stage B uses definitive radiotherapy.
15901032|NCT03641534|Procedure|Lung Ultrasound examination|Use of lung ultrasound to detect pulmonary complications
15901033|NCT03641534|Procedure|Compression ultrasonography (CUS)|CUS is a highly sensitive and specific modality used to recognize lower extremity deep venous thrombosis (DVT)
15901034|NCT03641534|Procedure|Echocardiography|Echocardiogram can be (i) identify imminent life-threatening causes of hemodynamic failure, (ii) recognize coexisting diagnoses that complicate management, (iii) follow the evolution of the disease process, and (iv) monitor response to treatment
15901035|NCT03641534|Procedure|Inferior Vena Cava ultrasound|Measurement of the inferior vena cava diameter
15901036|NCT03641534|Procedure|Passive leg raising test (PLR)|Baseline assessment (including pulse rate, systolic and diastolic blood pressure, velocity time integral (VTI) and stroke volume (SV) echocardiographic measurements) will be performed in the resting semi-recumbent position, defined as a position with the trunk elevated 30° to 45° relative to the lower limbs.
15901037|NCT03641534|Procedure|Orthogonal polarization spectral imaging (OPS)|Measurement of capillary flow in the rectal microcirculation
15901038|NCT03641534|Procedure|Urine collection (Foley catheter)|For urinalysis, biochemistry, urine microscopy, pH, and culture.
15901063|NCT03641365|Device|Test group|Guided Implant placement Positioning/placement of dental implants thought the fully acrylic surgical template without metallic sleeves.
15901039|NCT03641534|Procedure|Venous blood samplings|for: parasitological and microbiological diagnostics, complete blood count, biochemistry, red cell deformability analyzed by laser assisted rotational cell analyser (LORCA), markers of oxidative stress (peripheral intravenous catheter)
15901040|NCT03641534|Procedure|Electrocardiogram|all patients will have an ECG performed on enrolment as a non-invasive investigation
15901041|NCT03641534|Procedure|GlycoCheck|GlycoCheck is a clinical sublingual handheld, bedside microscope that detects erythrocytes within the small sublingual blood vessels measuring 5 to 25 micrometers in diameter. The sublingual vasculature is a validated site for measuring thickness of the endothelial glycocalyx.
15901042|NCT03641521|Behavioral|Parent-led behavioral strategies|Intervention parents participated in an additional 20-25-min segment led by the nutrition educator during which the week's behavioral strategy was introduced. The following six behavioral strategies were introduced (one each week) as a segment of each cooking skills session: 1) have your child help prepare vegetables for meals (Child Help), 2) use a plate that shows the amount of vegetables to include for a meal (My Plate), 3) make vegetables visible and accessible by removing other foods from the dining area during the meal and leaving the vegetables (Make Avail/Visible), 4) serve at least 2 vegetables with the meal (Serve 2), 5) serve vegetables before the meal (Serve First), and 6) use a bigger spoon to serve the vegetables (Big Spoon).
15901043|NCT03641508|Drug|Triamcinolone|Triamcinolone acetonide (Kenalog; 10 mg/mL; insoluble). This will be mixed with 1% lidocaine without epinephrine
15901044|NCT03641508|Drug|Dexamethasone|dexamethasone sodium phosphate (Decadron; 4 mg/mL; soluble). Again, this will be mixed with 1% lidocaine without epinephrine
15901045|NCT03641495|Other|PE+ET|"To explain the physiology of nervous system and the mechanism and modulation of acute and chronic pain.
~To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate."
15901046|NCT03641495|Other|ET|To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.
15901047|NCT03641482|Drug|NBF|Once the molar is extracted, the socket is cleaned with water, NBF gel is introduced, and the flap is closed. Then, the patients are instructed to apply NBF Gel in the surgical wound 3 times per day for 7 days after brushing their teeth. Previously they have to dry the area of the wound with gauze.
15901048|NCT03641482|Device|Placebo|Once the molar is extracted, the socket is cleaned with water, placebo gel is introduced, and the flap is closed. Then, the patients are instructed to apply placebo gel in the surgical wound 3 times per day for 7 days after brushing their teeth. Previously they have to dry the area of the wound with gauze.
15901049|NCT03641469|Device|Green Sun Dynamic Brace|Change from standard-of-care TLSO to GSM brace
15901050|NCT03641456|Drug|bortezomib|The investigators gave patients subcutaneous bortezomib 1.3mg/m2 on days 1, 8,15, and 22 of a 28-day cycle. More two induction cycles after obtaining maximum response but no less than six cycles totally.Responding patients could receive maintenance therapy comprising 4-week cycles of bortezomib on days 1 and 15 at the dose level of 1.3mg/m2. Patients discontinued treatment if they had progressive disease or or unacceptable toxic effects not controlled with dose modifications.
15901051|NCT03641456|Drug|Lenalidomide|The investigators gave patients oral lenalidomide 25mg on days 1 to 21 of a 28-day cycle. More two induction cycles after obtaining maximum response but no less than six cycles totally.Responding patients could receive maintenance therapy comprising 4-week cycles of lenalidomide on days 1 to 21 at the dose level of 10mg. Patients discontinued treatment if they had progressive disease or unacceptable toxic effects not controlled with dose modifications.
15901052|NCT03641456|Drug|Dexamethasone|The investigators gave patients oral dexamethasone 40mg on days 1, 8, 15 and 22 of a 28-day cycle. More two induction cycles after obtaining maximum response but no less than six cycles totally.
15901053|NCT03641443|Device|Non-invasive measurement of intracranial pressure|Non-invasive measurement of intracranial pressure in patients with mass effective brain Tumors
15901054|NCT03641430|Other|Supportive care with OCT product|Participants will apply over-the-counter product for a certain period with or without light challenge. We will perform clinical assessments of the skin associated with product application as well as assess these changes with and without light challenge. Skin biopsies will be obtained following standard medical practice and will be used to analyze skin markers related to photoaging, pigmentation, oxidative stress, and other dermatologic conditions.
15901055|NCT03641417|Drug|GLWL-01|"Small molecule inhibitor of Ghrelin-O-Acyltransferase (GOAT) to reduce levels of circulating acyl ghrelin.
~(Defined as a mechanistic study by MHRA; intervention not for therapeutic purposes in this study.)"
15901056|NCT03641417|Other|Placebo|Same as GLWL-01, but no active ingredient
15901057|NCT03641404|Dietary Supplement|ergothioneine|Ergothioneine is naturally occurring thiol compound obtained solely from diet in humans. Ergothioneine is widely reported to be a natural antioxidant and anti-inflammatory compound. In addition we hypothesize that this compound will be beneficial in improving cognition.
15901058|NCT03641404|Dietary Supplement|placebo|Placebo. Study control (99% microcrystalline cellulose)
15901059|NCT03641391|Procedure|Intraoperative direct cortical electrical stimulation|Intraoperative direct electrical stimulation on language or language-associate cortex, was performed using a 5-mm wide bipolar electrode with a pulse frequency of 60 Hz and an amplitude of 1.5 to 6 milliamperage. The somatosensory evoked potential was recorded with a 6-contact subdural strip electrode. If after-discharge activity indicated that the stimulation current was too high, the current amplitude was decreased by 0.5 to 1 milliamperage. The participants would be undergone awake anesthesia and asked to perform language tasks during the stimulation.
15901060|NCT03641391|Procedure|Intraoperative direct subcortical electrical stimulation|Intraoperative direct electrical stimulation on language or language-associate subcortical pathways, was performed using a biphasic square-wave pulse delivered at 60 Hz with a current amplitude ranging from 1.5 to 10 milliamperage. The somatosensory evoked potential was recorded with a 6-contact subdural strip electrode. If after-discharge activity indicated that the stimulation current was too high, the current amplitude was decreased by 0.5 to 1 milliamperage. The participants would be undergone awake anesthesia and asked to perform language tasks during the stimulation.
15901061|NCT03641378|Other|Palliative Care Intervention|team of clinicians that specialize in the lessening (palliation) of many distressing symptoms
15901062|NCT03641378|Other|Standard Transplant Care|Standard care per hospital guidelines
15901654|NCT03636542|Drug|bupivacaine|Active comparator
15901064|NCT03641365|Device|Control group|Guided Implant placement Positioning/placement of dental implants thought the acrylic surgical template with metallic sleeves.
15901065|NCT03641352|Drug|CKD-501 0.5mg|CKD-501 0.5mg, orally, 1 tablet once a dqy for 24weeks or 52weeks (if extension study) with D150 and D759
15901066|NCT03641352|Drug|Placebo|Placebo, orally, 1 tablet once a dqy for 24weeks or 52weeks (if extension study) with D150 and D759. CKD-501 placebo will be changed to CKD-501 from extension study to EOS(end of study).
15901067|NCT03641339|Other|One vector feeding|Participants will undergo one feeding by one of three colony- reared vectors (Aedes aegypti mosquitos, Anopheles gambiae mosquitos, or Lutzomyia longipalpis sand flies)
15901068|NCT03641339|Other|Four vector feeding|Participants will undergo four feedings by one of three colony- reared vectors (Aedes aegypti mosquitos, Anopheles gambiae mosquitos, or Lutzomyia longipalpis sand flies), each about 2 weeks apart, with the same vector type.
15901069|NCT03641326|Drug|Sunitinib|Sunitinib will be administered at a dose of 50 mg daily for 2 consecutive weeks followed by 1 week of rest until there is disease progression or development of intolerable side effects.
15901070|NCT03641326|Device|wGT3x-BT|Participants will given a small, portable pager-type and watch accelerometers to wear at the hip or non-dominant wrist. Worn daily for 6 cycles
15901071|NCT03641313|Drug|Berzosertib|Given IV
15901072|NCT03641313|Drug|Irinotecan|Given IV
15901073|NCT03641300|Device|Magnetic Seizure Therapy (MST)|"MST treatment will be administered using the MagPro MST with a Cool TwinCoil over the frontal cortex in the midline position using 100 Hz stimulation. The MST determination of seizure threshold will be done using 100% machine output applied at 100 Hz at progressively escalating train durations, commencing at 2 seconds and increasing by 2 seconds with each subsequent stimulation until an adequate seizure is produced. During subsequent sessions, one stimulation will be delivered using a train duration that is 4 seconds longer than the train duration at threshold (with a maximum train duration of 10 seconds).
~This will be performed under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes."
15901074|NCT03641300|Device|Electroconvulsive Therapy (ECT)|In the ECT arm treatment, the MECTA spectrum 5000Q machine will be used, which is an FDA approved device used for providing standard-of-care clinical ECT treatments. The ECT determination of seizure threshold and the adjustment of energy at subsequent sessions will be based on a standard published protocol. All participants will receive RUL-UB ECT at six times the seizure threshold under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes
15901075|NCT03641287|Other|Exercise Counseling|Meet with exercise physiology
15901076|NCT03641287|Other|Aerobic Exercise|Receive prescription for moderate aerobic exercise
15901077|NCT03641287|Other|Physiological Support|Receive motivational support via telephone care
15901078|NCT03641287|Other|Quality-of-Life Assessment|Ancillary studies
15901079|NCT03641287|Other|Questionnaire Administration|Ancillary studies
15901080|NCT03641287|Other|Best Practice|Undergo habitual level of physical activity
15901081|NCT03641274|Other|Case-management intervention for frequent users of the emergency department|The CM intervention to be implemented is an evidence-based practice. It consists of individualized services based on a detailed baseline evaluation using validated scales to identify all of the social and medical needs of each FUED. The CM team provides counseling and education on health care utilization, substance abuse and the social determinants of health directly to the FUEDs, using skills such as motivational interviewing and cross-cultural competences. Additionally, the CM team provides concrete services including, referral to psychiatric or substance abuse treatment, or medical services (such as a GP or medical specialist), on a case-by-case basis. Another key element of the CM intervention is to connect all health care or social service providers within the hospital or in the community, promoting continuity of care and improving the FUEDs' ability to navigate the complex health care system.
15901082|NCT03641261|Other|Therapeutic patient education program|WebIchtyose is a specific therapeutic patient education program for patients with hereditary Ichthyosis targeting the problems of each patient by means of a personalized follow-up and a constant interaction between the patient and the educational team
15901083|NCT03641248|Drug|Enteric coated Devil's Claw|Enteric coated capsules containing Devil's Claw extract with 100mg harpagoside
15901084|NCT03641248|Drug|Non-enteric coated Devil's Claw|Non-enteric coated capsules containing Devil's Claw extract with 100mg harpagoside
15901085|NCT03641235|Biological|Sputum collection|Analysis of Sputum collection
15901086|NCT03641222|Device|Acupuncture|Traditional Chinese Medicine (TCM) Acupuncture
15901087|NCT03641209|Drug|Paracetamol 10mg/mL infusion solution|Intravenous paracetamol solution for infusion
15901088|NCT03641209|Other|Placebo|Half physiological saline solution as the non-active placebo solution
15901089|NCT03641196|Device|Fixed appliance|Use of a cemented modified palatal Nance appliance presenting a bite-plane
15901090|NCT03641196|Procedure|Composite bite plane|treatment with a composite build up in the palatal aspect of the upper central incisors.
15901091|NCT03641170|Behavioral|Physical activity|Interval walking performed after each main meal.
15901092|NCT03641170|Behavioral|Inactivity|Inactivity after each main meal.
15901093|NCT03641170|Other|Fixed diet.|Participants will receive a fixed diet through out the intervention period and control period.
15901094|NCT03641157|Other|Easy Intubation|
15901095|NCT03641144|Device|Navigation laser|Navigation laser device is a scanning slit-based instrument.before treatment the surgeon plan laser spots on the screen based on image(infrared, colour, fluorescein angiography)and then apply automated patterns and single spots as appropriate.the device will automatically carry out the plan.
15901096|NCT03641144|Device|Traditional laser|Traditional laser is a slitlamp based instrument.Surgeon operate traditional laer device while watching Participant's image(infrared, colour, fluorescein angiography) and then manually aim at and trigger laser.
15901155|NCT03640572|Diagnostic Test|Bone marrow analysis to identify disseminated tumour cells|Pelleted cells from bone marrow samples were incubated with an excessive amount of lysing solution for 10 min, repeated 3-4 times to remove erythrocytes. The slides were dried, fixed with a mixture of ethanol and acetone (1 : 1 v v-1), and then stained for 30 min with A45-B/B3 monoclonal antibodies (5 μg ml-1) (Micromet GmbH, Germany), which recognise common epitopes of cytokeratins (CK) including CK 8, 18 and 19.
15901097|NCT03641118|Diagnostic Test|Cardiopulmonary exercise test|The CPET test involves cycling on an exercise bike for 8-12 minutes. Starting with a very low resistance on the pedals the patient will pedal at 60 revolutions per minute. After 3 minutes of cycling, the resistance will gradually increase until the patient can no longer turn the pedals at the required speed. The test will be thoroughly explained to the patient beforehand and trained staff will make the experience as comfortable as possible. CPETs will be stopped early by the study researcher/doctor in the presence of any adverse events. Each CPET appointment will last approximately one hour.
15901098|NCT03641105|Diagnostic Test|Diagnostic test|detect the contents of glucose metabolism molecules using mass spectrum
15901099|NCT03641092|Behavioral|CenteringParenting Intervention|The CenteringParenting(CP) intervention includes group well child care visits during the first 24 months of life. Participants receive a journal with child safety, health and development information. The groups are co-led by a practitioner and support staff member. This bundled intervention supports healthy parent-child interactions and early learning through education and experiential learning within the well-child visit.
15901100|NCT03641092|Behavioral|Routine Well Child Care|The Comparison Clinical Sites will receive the Routine Well Child Care standard individual clinical care. This clinic will receive delayed training in the CenteringParenting(CP) intervention approximately 3 months after the completion of recruitment at their study site [when recruited families will be ineligible for CenteringParenting groups that will start in control sites]. They will receive anticipatory guidance and handouts that are standard for the clinic.
15901101|NCT03641079|Drug|Brinjal peel extract containing cream|Brinjal peel extract, white wax, white petrolatum, stearyl alcohol
15901102|NCT03641066|Device|Ankle Brace|Each participant will complete the 1 minute walking and 2 minute running under 5 conditions [1] un-braced, [2] Active Ankle 329 Ankle Sleeve, [3] AS1Pro (a lace-up brace), [4] Eclipse 1 (single-upright brace), and [5] Eclipse 2 (double upright brace)
15901103|NCT03641053|Other|Honey|Substance is given topically after the wound has been sutured
15901104|NCT03641053|Other|Povidone-iodine|Substance is given topically after the wound has been sutured
15901105|NCT03641053|Other|Paraffin gauze|Substance is given topically after the wound has been sutured
15901106|NCT03641040|Diagnostic Test|Video-oculography|measure and analyze angles of ocular deviations between dominant and non-dominant eye using VOG with alternate cover.
15901107|NCT03641040|Diagnostic Test|Alternative prism cover test|measure and analyze angles of ocular deviations between dominant and non-dominant eye using APCT
15901108|NCT03641027|Other|Increased physical activity|"Preoperatively
~Individual coaching by a physical therapist to:
~increase physical activity 30 minutes/day (At least 150 min/week)
~decrease time spent sitting/lying
~Telephone follow up one week after the intervention starts
~At the hospital
~-Frequent mobilization
~After discharge
~A telephone follow up one week postoperatively with coaching by a physical therapist to:
~increase physical activity 30 minutes/day (At least 150 min/week) until 8 weeks postoperatively
~decrease time spent sitting/lying
~The intervention includes a prescribed FaR (Fysisk aktivitet på recept) with frequency, duration and intensity of the activity corresponding 12-15 on the BORG-RPE scale."
15901109|NCT03641027|Other|Standard care|
15901110|NCT03641014|Other|pH Effect on blastocyst formation|to investigate which pH is suitable for each stage of embryo development
15901111|NCT03641001|Behavioral|Child feeding counselling, food voucher, micronutrient powder, WASH|Child feeding counselling will be assisted by food voucher, micronutrient powder and WASH messages
15901112|NCT03640988|Device|dermaPACE|Shockwave application
15901113|NCT03640975|Other|Endoscopy|The endoscopy will be performed under general anaesthesia using a flexible endoscope with an external diameter of between 4.9 and 9.2 mm, depending on the size of the child. In line with the guidelines, eight biopsies will be collected from the proximal, median and distal oesophagus for the routine analysis of esophageal remodelling and inflammation. Three of these biopsies will be used in the context of this study to analyse innate immune cells using flow cytometry and to determine the profile of cytokine expression. Two biopsies will be placed in sterile, 0.5 ml Nunc tubes containing a storage buffer (MACS® Tissue Storage Solution) and then stored in ice until the extraction of cells for cytometric analysis . The third specimen will be placed in a sterile tube and frozen immediately in liquid nitrogen for analyses of the esophageal microbiome.
15901114|NCT03640962|Other|Evaluation|This cross-sectional study was conducted in 368 postmenopausal women aged between 40 and 65 years. This study was carried out in family health centers in Istanbul. Data were collected via face-to-face interviews by the researchers.
15901115|NCT03640949|Drug|Vasopressin, Arginine|20 IE of vasopressin per dose for a maximum of four doses (80 IU)
15901116|NCT03640949|Drug|Methylprednisolone|40 mg methylprednisolone once
15901117|NCT03640949|Drug|NaCl|Placebo
15901118|NCT03640936|Behavioral|Induced Sputum|Total IgE and Specific IgE to Dermatophagoides pteronyssinus in Induced Sputum
15901119|NCT03640923|Other|a swab of mucous membrane|a swab of mucous membrane in oredre to analyse the genome
15901120|NCT03640910|Device|OT Equators® (Rhein83)|Attachment systems to retain an implant overdenture
15901121|NCT03640910|Device|Locator® (Zest)|Attachment systems to retain an implant overdenture
15901122|NCT03640897|Device|Liniderm|Cleaning of the diaper area with Liniderm at each diaper change during 28 days
15901123|NCT03640897|Other|Wipes|Cleaning of the diaper area with wipes at each diaper change during 28 days
15901124|NCT03640897|Other|Water|Cleaning of the diaper area with water and cotton pads at each diaper change during 28 days
15901125|NCT03640884|Drug|Xueshuantong-Injection|Xueshuantong-Injection is a kind of natural compound injection extracted from Chinese herb Notoginseng. The major bioactive ingredient is panax notoginseng saponins.
15901126|NCT03640871|Device|URGO AWC_019 dressing (AWC=Advanced Wound Care)|URGO AWC_019 dressing 10x10 cm (AWC=Advanced Wound Care)
15901127|NCT03640858|Device|Theranova Dialyzer|The Theranova dialyzer will be used for each of the hemodialysis treatments beginning week 3 and ending at the end of the dialysis week on week 14 and again starting week 23 and ending at the end of the dialysis week on week 46 . This will allow us to compare patient reported symptoms in weeks 1 and 2 when patients are on their usual dialyzer with their symptoms using the Theranova dialyzer. This will also allow us to see if there is a carry-over effect.
15901156|NCT03640559|Drug|Seroguard|
15901157|NCT03640559|Drug|Placebos|
15921190|NCT03488693|Other|No Radiation|No radiotherapy given
15901128|NCT03640845|Other|tele-expertise|"Tele-expertise consists of the remote realization of a multi-professional medication review (clinical pharmacist and doctor / geriatrician), ie a complete and systematic analysis of sociodemographic, clinical, biological and pharmaceutical data transmitted in such a way standardized at the EHMP and aimed at optimizing the therapeutics of the resident patient of the EHPAD requesting tele-expertise.
~Tele-expertise is realized in three stages, that are
~the transmission, the collection and the organization of the data,
~the analysis of the data and their confrontation with the referential and recommendations
~the writing of a Personalized Pharmaceutical Plan"
15901129|NCT03640832|Other|Developmental Serum|A 30millilitre (mL) bottle with a piston pump will be dispensed to the participants, to be used as a topical dermal (facial) application, twice daily as per normal home use.
15901130|NCT03640832|Other|Physiogel Calming Relief Anti-Redness Serum|A 30mL bottle with a piston pump will be dispensed to the participants, to be used as a topical dermal (facial) application, twice daily as per normal home use.
15901131|NCT03640819|Procedure|Tattooing of biopsied node|Tattooing (marking) of biopsied node with carbon dye (SPOT dye) at the time of fine needle aspiration or core biopsy or separate visit under ultrasound guidance. The dye will be injected in the cortex of the node and the perinodal tissue under ultrasound guidance. Patients will undergo standard (routine) armpit surgery and may receive neoadjuvant chemotherapy as planned by the clinical team. This could be removal of a few lymph glands (sentinel node biopsy) or removal of all the lymph glands (axillary lymph node dissection) in the armpit. The surgeon will try to identify and remove the tattooed lymph gland at the time of planned armpit surgery.
15901132|NCT03640806|Other|PHYSICAL ACTIVITY|3 fibromyactiv workshops per week during the first 6 months, or 72 sessions. Each workshop lasts 2 hours of physical activity.
15901133|NCT03640793|Device|Implantation|Implantation of 6 PPIS implants
15901134|NCT03640780|Other|observation|The surgical ages and other information between two groups were compared.
15901135|NCT03640767|Behavioral|Message-based lifestyle intervention|Peripheral artery disease patients who have received revascularization in the past 6 months, are randomized into 2 groups. The total sample size will be 160. Both intervention and control groups will receive face-to-face lifestyle adherence counseling and booklets at baseline. The intervention group will receive 4 mobile phone messages per week for 24 weeks. The messages are motivational advice to support lifestyle behavioral modification in various stages of behavioral changes.
15901138|NCT03640741|Procedure|Laparoscopy|The studies are carried out on patients who undergoes gynecological procedure that involves laparoscopy.
15901139|NCT03640728|Drug|Tenofovir Alafenamide|Tenofovir alafenamide 25 mg/day orally
15901140|NCT03640728|Drug|Entecavir|Entecavir 0.5 mg/day orally
15901141|NCT03640728|Drug|Tenofovir disoproxil fumarate|Tenofovir Disoproxil Fumarate 300 mg/day orally
15901142|NCT03640715|Other|ENVU|"ENfant VUlnerable: a clinical tool for screening for social and health vulnerability in pediatrics - tool: VUlnerable Child (ENVU) -; to allow for an appropriate orientation of the patient care pathway. The metrological validation of diagnostic performances (sensitivity, specificity, positive and negative likelihood ratios) will be studied in confrontation with the opinion of an expert caregiver in the care of vulnerable populations."
15901143|NCT03640702|Other|Protocol change|To examine the effect of prolonging the second stage of labor on the rate of cesarean delivery, maternal and neonatal outcomes
15901144|NCT03640689|Device|Endovenous ablation + iliac US +/- iliac stenting|Concomitant Ablation of the GSV with endovenous therapy with associated iliac vein interrogation and stenting if required
15901145|NCT03640689|Device|Endovenous ablation of Great Saphenous Vein|Ablation of the Great Saphenous Vein and subsequent Graduated Compression
15901146|NCT03640676|Device|FlowOx|FlowOx is a CE marked device developed to increase blood flow to the lower extremities. A pressure chamber is sealed around the leg below the knee and is connected to a control unit which induces pulses of 10 sec negative pressure, and 7 sec of atmospheric pressure.
15901147|NCT03640663|Other|Midwife led continuity model of care|Midwives from the hospitals provided outreaching caseload ante- and postnatal care to women in rural villages clinics and homes
15901148|NCT03640650|Combination Product|Dropless Therapy|The Dropless will be injected, as a single administration, into the vitreous cavity during the cataract surgery.
15901149|NCT03640650|Drug|Usual Care|In order to reflect real-world clinical practice, the choice of topical ophthalmic medications as well as dosage, posology, and duration of treatment will be left to the discretion of the treating ophthalmologist.
15901150|NCT03640624|Combination Product|Multidisciplinary treatment|"Assessment by gynaecologist and dermatologist, resulting in tailored vulvar care, including daily topical lidocaine 5% ointment. Other topical or oral medication, such as oestradiol cream or oral antidepressants will be prescribed on individual basis.
~Tailored physiotherapy targeting muscular dysfunction, utilizing: Patient education, pelvic floor muscle exercises (contraction and relaxation), EMG-biofeedback. Low frequent electrical stimulation, massage, stretching and myofascial release and trigger point treatment of the pelvic floor. Desensitization exercises (manually or vaginal dilator). Relaxation and body awareness. Minimum one visit per month.
~Guided imagery sessions, minimum twice a week using a sound track that is developed for vulvodynia patients."
15901151|NCT03640624|Combination Product|Treatment as usual|Treatment as usual in accordance with local guidelines by specialist in gynaecology, including a minimum of two visits (when diagnosis is made and after 3 months)
15901152|NCT03640598|Procedure|Ilioinguinal/iliohypogastric nerve blocks|The patient will receive ultrasound-guided Ilioinguinal/iliohypogastric nerve blocks with0.5 ml/kg 0.125 mg/kg bupivacaine + fentanyl 2ug/ml injectate
15901153|NCT03640598|Procedure|Erector spinae nerve block|The patient will receive ultrasound-guided erector spinae nerve block 0.5 ml/kg 0.125 bupivacaine + fentanyl 2ug/ml injectate.
15901154|NCT03640585|Other|Music therapy|Only the neurodevelopmental therapy was applied in the second group without music. A total of 15 treatments were administered for 5 weeks, 3 sessions per week for all patients. The sessions were 45 minutes.
15901158|NCT03640546|Behavioral|Within My Reach/ Within Our Reach|Relationship education workshops
15901159|NCT03640533|Behavioral|Nanit-Insights|Nanit-Insights is an app-based intervention that provides personalized sleep tips to parents.
15921327|NCT03487562|Drug|Clarithromycin|Clarithromycin 500 mg
15901160|NCT03640520|Device|FACETS: Pediatric Resuscitation|Family-centered & Trauma-informed Support in Pediatric Resuscitation (FACETS: Pediatric Resuscitation) is an online skills training module for health care professionals involved in pediatric resuscitation in general EDs. The module combines didactic information and scenario-based learning with opportunities for the learner to practice applying their knowledge of FCC practices at key choice points in realistic pediatric resuscitation case scenarios. Training content is guided by evidence regarding FCC practices that are effective in reducing concurrent and ongoing emotional distress in children and family members, and in promoting child and family involvement and satisfaction with care.
15901161|NCT03640520|Device|Control|An online training module in which participants will receive information and policy education about national pediatric readiness standards for all EDs (including a brief mention of family-centered care as one of these standards), with no specific skills training in FCC. The module provides practice-relevant knowledge related to pediatric differences and pediatric readiness
15901162|NCT03640507|Drug|Chlorhexidine-alcohol|Intervention is a 30-second vaginal preparation or topical wash with three chlorhexidine-alcohol 0.5% solution-soaked sponge sticks.
15901163|NCT03640507|Drug|Povidine-iodine|Intervention is a 30-second vaginal preparation or topical wash with three povidine-iodine 10% solution-soaked sponge sticks.
15901164|NCT03640507|Drug|Sterile saline|Intervention is a 30-second vaginal preparation or topical wash with three sterile saline-soaked sponge sticks.
15901165|NCT03640494|Device|Optical Coherence Tomography|This is an observational study in which subjects will be imaged with optical coherence tomography (OCT). OCT systems are optical imaging technology that allow non-contact imaging of the microanatomy of the retina, optic nerve head and retinal blood vessels. The OCT devices are held above (and do not touch) the eye. Unlike visible light from many examination devices, the infrared OCT beam is barely visible to the human eye as it sweeps across the retina. Thus the infant is not disturbed by the light.
15901166|NCT03640481|Drug|Belumosudil (KD025)|Belumosudil is an orally available Rho-associated protein kinase-2 (ROCK2) selective inhibitor.
15901167|NCT03640468|Drug|Ketamine full dose|This group will receive induction of anesthesia using Ketamine 1 mg/Kg
15901168|NCT03640468|Drug|Ketamine half dose|This group will receive induction of anesthesia using Ketamine 0.5 mg/Kg
15901169|NCT03640468|Drug|Lidocaine|This group will receive lidocaince 1 mg/Kg
15901170|NCT03640468|Drug|Midazolam|This group will receive midazolam 0.05 mg/Kg
15901171|NCT03640468|Drug|Normal saline|This group will receive normal saline 10 mL
15901172|NCT03640455|Device|Placebo|A tDCS (Low Current Transcranial Stimulation) device with two electrodes: active and reference, will be used. The tDCS will be applied next to the cortical representation zone of the primary motor cortex and left pre-motor for 30 minutes; placebo (dummy stimulation), according to the patient's randomization arm.
15901173|NCT03640455|Device|Anodal|A tDCS (Low Current Transcranial Stimulation) device with two electrodes: active and reference, will be used. The tDCS will be applied next to the cortical representation zone of the primary motor cortex and left pre-motor for 30 minutes; intensity 2 mA, in anodal polarity, according to the patient's randomization arm.
15901174|NCT03640455|Device|Cathodal|A tDCS (Low Current Transcranial Stimulation) device with two electrodes: active and reference, will be used. The tDCS will be applied next to the cortical representation zone of the primary motor cortex and left pre-motor for 30 minutes; intensity 2 mA, in cathodal polarity, according to the patient's randomization arm.
15901175|NCT03640442|Other|Modified ramped position|This position will be achieved using a special pillow. Shoulders will be elevated and neck will be extended to bring the breasts away from the laryngoscopy. The patient will be positioned so that the tip of the last spinous process (C7) will be at the edge of the pillow. The neck will be extended to the most possible range.
15901176|NCT03640442|Other|Ramped position|This position will be achieved by elevation of the shoulders and the head elevation till achieving alignment of sternal notch and external auditory meatus
15901177|NCT03640429|Device|non-invasive blood pressure monitor|non-invasive oscillometric blood pressure monitor will be applied at the arm, forearm, and at the wrist.
15901178|NCT03640429|Device|invasive blood pressure monitor|invasive blood pressure monitor will be connected to a cannula inserted at the radial artery.
15901179|NCT03640416|Device|Fitbit® Charge HR smart watch|The Fitbit® Charge HR is a commercial product widely used worldwide, and data from the device is sent to a secured online server and can be accessed by each user to see only data collected from his own device. Data collected from the Fitbit® Charge HR is described earlier.
15901180|NCT03640403|Drug|Dihydroartemisinin-piperaquine|Dihydroartemisinin-piperaquine (DP). One of the Artemisinin combination therapy(ACTs), indicated for treatment of uncomplicated malaria. It will to be given every 4 months 3 rounds for a year.
15901181|NCT03640403|Drug|Artesunate-amodiaquine|Artesunate-amodiaquine (ASAQ). One of the Artemisinin combination therapy(ACTs), indicated for treatment of uncomplicated malaria. It will to be given every 4 months 3 rounds for a year.
15901182|NCT03640390|Drug|Dexmedetomidine|This group will receive Dexmedetomidine infusion at a rate of 0.5 mcg/kg/hour.
15901183|NCT03640390|Drug|Magnesium Sulphate|This group will receive Magnesium sulphate infusion at a rate of 15 mg/Kg/hour
15901184|NCT03640390|Drug|Normal saline|This group will receive normal saline infusion
15901185|NCT03640377|Drug|Praziquantel|Praziquantel given as crushed tablets (40 or 80 mg/kg)
15901186|NCT03640351|Drug|1. Use of preservative free diquafosol ophthalmic solution after cataract surgery|Participants are randomly assigned into the preservative free diquafosol group (Group 1), the preservative containing diquafosol group (Group 2) or the hyaluronate group (Group 3) using a simple unrestricted randomization method by the controller. The group 1 uses preservative free 3% diquafosol tetrasodium ophthalmic solution (Diquas-S; Santen Pharmaceutical Co, Ltd, Osaka, Japan) 6 times a day, the group 2 uses 3% diquafosol tetrasodium ophthalmic solution (Diquas; Santen Pharmaceutical Co, Ltd) 6 times a day and the group 3 uses 0.15% sodium hyaluronate ophthalmic solution (New Hyaluni 0.15%; Taejoon, Seoul, Korea) 6 times a day. All three groups instill each eye drop from postoperative day 1 to postoperative 12 weeks.
15901275|NCT03639701|Drug|Thymidine|Mitochondrial DNA nucleotide precursors. Dose escalation: 130mg/kg/day x 14 days, 260 mg/kg/day x 14 days, and 400mg/kg/day as tolerated. Compounds are taken orally and divided into 3 doses daily.
15901276|NCT03639688|Procedure|Left sided threading|threading of the endotracheal tube over the fiberoptic bronchscope from the left lip commissure
15901187|NCT03640351|Drug|2. Use of preservative containing diquafosol ophthalmic solution after cataract surgery|Participants are randomly assigned into the preservative free diquafosol group (Group 1), the preservative containing diquafosol group (Group 2) or the hyaluronate group (Group 3) using a simple unrestricted randomization method by the controller. The group 1 uses preservative free 3% diquafosol tetrasodium ophthalmic solution (Diquas-S; Santen Pharmaceutical Co, Ltd, Osaka, Japan) 6 times a day, the group 2 uses 3% diquafosol tetrasodium ophthalmic solution (Diquas; Santen Pharmaceutical Co, Ltd) 6 times a day and the group 3 uses 0.15% sodium hyaluronate ophthalmic solution (New Hyaluni 0.15%; Taejoon, Seoul, Korea) 6 times a day. All three groups instill each eye drop from postoperative day 1 to postoperative 12 weeks.
15901188|NCT03640351|Drug|3. Use of preservative free sodium hyaluronate ophthalmic solution after cataract surgery|Participants are randomly assigned into the preservative free diquafosol group (Group 1), the preservative containing diquafosol group (Group 2) or the hyaluronate group (Group 3) using a simple unrestricted randomization method by the controller. The group 1 uses preservative free 3% diquafosol tetrasodium ophthalmic solution (Diquas-S; Santen Pharmaceutical Co, Ltd, Osaka, Japan) 6 times a day, the group 2 uses 3% diquafosol tetrasodium ophthalmic solution (Diquas; Santen Pharmaceutical Co, Ltd) 6 times a day and the group 3 uses 0.15% sodium hyaluronate ophthalmic solution (New Hyaluni 0.15%; Taejoon, Seoul, Korea) 6 times a day. All three groups instill each eye drop from postoperative day 1 to postoperative 12 weeks.
15901189|NCT03640338|Device|Cold-Therapy System|After surgery, participants assigned to this group will receive the cold-therapy system to use at the hospital and during the first 2 weeks following discharge.
15901190|NCT03640325|Behavioral|PRISM (Promoting Resilience in Stress Management)|Manualized Skills-Training Program targeting resilience resources: stress-management, goal-setting, cognitive reframing, and meaning-making
15901191|NCT03640312|Drug|QUARTET LDQT|Ultra-low-dose combination therapy comprising four different blood pressure lowering drugs at 1/4 dosages. Taken once daily for 12 weeks.
15901192|NCT03640312|Drug|Candesartan|Standard monotherapy of 8mg candesartan. Taken once daily for 12 weeks.
15901193|NCT03640299|Procedure|ERAS procedure|Optimized preoperative, intraoperative and postoperative procedures.
15901194|NCT03640286|Device|VeSTAL|The aim of this study is to evaluate the efficacy of non-invasive electrical vestibular nerve stimulation in combination with a lifestyle modification program, as a method of reducing excess body weight and body fat, as compared to a sham device in combination with the same lifestyle modification program.
15901195|NCT03640273|Drug|Prapchompoothaweep remedy|Take Prapchompoothaweep remedy capsule at 1,000 mg for 3 times a day before meals.
15901196|NCT03640273|Drug|Loratadine 10 Mg|Take Loratadine 10 mg once a day before meals.
15901197|NCT03640260|Behavioral|breathing regulation with physical activity|The subjects will have education leaflets with breathing and oximetry level evaluation training.
15901198|NCT03640247|Drug|Non-narcotic group regimen|Non-Narcotic Group. Receives only alternating acetaminophen and ibuprofen
15901199|NCT03640247|Drug|Narcotic group regimen|Narcotic Group: Alternating acetaminophen and ibuprofen, with a prescription of 10 tablets oxycodone (or if needed based on patient allergies, hydrocodone 5 mg/tramadol 50 mg) for break through pain.
15901200|NCT03640221|Drug|Ertugliflozin|The sodium-glucose cotransporter 2 (SGLT2) inhibitors are an exciting new class of antidiabetic drugs that cause a modest reduction in high blood pressure and large reductions in the risk of cardiovascular disease (CVD) outcomes and renal outcomes in patients with advanced type 2 diabetes and very high CVD risk. However, the mechanistic underpinning of these CVD benefits is not well understood. this arm will allow us to test our hypothesis.
15901201|NCT03640221|Drug|Hydrochlorothiazide 12.5mg|comparator arm allow us to mimic the mild anti hypertensive effect seen with the SGLT-2 inhibitors in order to enable us to differentiate whether the cardiovascular protection seen with the SGLT-2 inhibitors is secondary to its antihypertensive effects vs the potential decrease in sympathetics.
15901202|NCT03640221|Device|Microneurography|"Multiunit recordings of postganglionic sympathetic nerve activity will be obtained with unipolar tungsten microelectrodes inserted selectively into skeletal muscle nerve fascicles of the peroneal nerve. The nerve signals are amplified, filtered (bandwidth 700-2000 Hz), rectified and integrated to obtain a mean voltage display of sympathetic nerve activity. Sympathetic bursts are counted by inspection of the neurograms. A deflection on the mean voltage display is counted as a burst if it has a minimal signal to noise ratio of 2:1. The interobserver and intraobserver variations in identifying bursts are <10% and < 5%, respectively."
15901203|NCT03640221|Other|SKNA recordings|SKNA recordings will be captured by placing ECG electrodes on the chest wall. Recordings will be obtained simultaneously with microneurographic recording. The two techniques will undergo identical filtering and processing of the neurophysiologic inputs which are then displayed simultaneously using identical output functions.
15901204|NCT03640221|Other|Static Handgrip|Subjects will perform static handgrip at 33% MVC for 2 minutes, using a Stoelting recording handgrip dynamometer. Force output will be recorded continuously and displayed on the computer screen in real time to provide the subject with visual feedback. MVC will be determined for each subject at the beginning of each experiment. Subjects will be instructed to avoid straining maneuvers, changes in breathing, and contraction of non-exercising muscles during the experimental protocols. Ratings of perceived exertion (RPE) will be obtained at the end of each exercise by using a 6- to 20-unit Borg scale. Static handgrip at 33% MVC is accompanied by reflex increases in muscle sympathetic nerve activity caused by activation of the acid-sensing unmyelinated muscle afferents.
15901205|NCT03640221|Other|Post-handgrip forearm vascular occlusion|This will be performed by inflating a pneumatic cuff on the upper exercising arm to suprasystolic pressure (220 mmHg) beginning 10 seconds before the subject stops gripping and ending 2 minutes into the post-exercise period. The vascular occlusion maintains intramuscular acidosis and thus the stimulation of acid-sensing unmyelinated skeletal muscle afferents and their reflex increase in muscle sympathetic nerve activity and BP, while the muscular relaxation eliminates central command and the attendant increase in heart rate (which returns to the baseline level). As soon as the cuff is release and the forearm circulation is restored, muscle sympathetic nerve activity quickly returns to the baseline level and BP soon follows.
15901277|NCT03639688|Procedure|Right sided threading|threading of the endotracheal tube over the fiberoptic bronchscope from the right lip commissure
15901278|NCT03639675|Drug|Aflibercept (EYLEA, BAY86-5321)|2 mg (0.05 mL), Intravitreal injection (IVT), single dose.
15902344|NCT03631433|Drug|Ibuprofen 600 mg|identical appearing tablets containing 600 mg of ibuprofen
15901206|NCT03640221|Other|Testing of the Arterial Baroreflex Function|We will compare effects of Ertugliflozin vs. low-dose HCTZ on sinoaortic baroreflex function in hypertensive diabetic subjects during both spontaneous fluctuations in arterial pressure and during decreases and increases in arterial pressure induced by the Valsalva maneuver. The aim of this protocol is to determine if the sympathetic nerve, as well as the heart rate, component of the sinoaortic baroreflex can be augmented by the SGLT2 inhibitor. After obtaining stable baseline recordings, arterial pressure, heart rate, and muscle sympathetic nerve activity will recorded during spontaneous fluctuations in BP over 5 minutes and during both decreases in BP during phase III of the Valsavla maneuver and during the phase IV overshoot in BP upon its release. Frequent accurate measurement of arterial pressure will be obtained with a highly-rated oscillometric arm monitor that records 6 BP readings per minute (Welch Allyn Vital Signs Monitor).
15901207|NCT03640208|Behavioral|Education presented by trained caregiver|After participants complete the Pre-test, an educational session will be presented by a trained caregiver, delivered in a lecture-style manner with Power Point projection of educational material. The slides in this presentation will be scripted to mitigate variability among different presenters. Topics addressed in the presentation include: CRC basics (including brief anatomy), data on disparity, risk factors, screening modalities, preventative measures, population disparities of CRC, colonoscopy exam and other screening tests. The emphasis will be on CRC risks factors and prevention. All required information that is needed to correctly answer post-test questions is embedded within the presentation.
15901208|NCT03640195|Other|Device: Transcutaneous acupoint electrical stimulation and seeds for auricular acupressure|"Experimental group received Acupoint stimulation, Transcutaneous acupoint electrical stimulation20 minutes/weeks, once a week for six consecutive weeks.
~The second part of The Experimental group received Auricular acupressure applied to four acupoints, including shenmen (TF2), mouth (IC6), subcortex (CW2), Occiput (AT3). each point is 1min, 5days/week, 3 times/day."
15901209|NCT03640182|Other|Health management model of TCM preventive medicine|The Health management model include: (1) Body constitution measurement (2) Health promotion literacy education lectures (3) Medical Ba-Duan-Jin duo-in qigong practice.
15901210|NCT03640169|Other|Health management of TCM preventive medicine|The Health management model include: (1) Body constitution measurement (2) Health promotion literacy education lectures (3) Duo-in qigong practice.
15901211|NCT03640156|Drug|Oxytocin|A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril) will be administered before the assessment of the neurophysiological measures.
15901212|NCT03640156|Other|Placebo|A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril) will be administered before the assessment of the neurophysiological measures.
15901213|NCT03640143|Other|venous blood lead|data about ve,nous blood lead
15901214|NCT03640130|Behavioral|Gaze-contingent text enhancement|"In different testing blocks, the efficacy of the different enhancements will be evaluated, such as inverting the text in a gaze-contingent inverted spotlight."
15901215|NCT03640104|Behavioral|Intervention-Nutrition guidelines|Subjects will receive an individualized dietary plan according to their nutritional status, socioeconomic and cultural preferences. Protein intake 1-1.5g/kg body weight; 30% fat (mono and polyunsaturated fatty acids), vitamin A sources (1300 RAE). Each subject will have 7 interchangeable options for every meal time, all equivalent in macronutrient content, and every two weeks a new menu will be provided by a nutritionist.
15901216|NCT03640104|Behavioral|Nutrition guidelines|Nutritional recommendations based on international guidelines
15901217|NCT03640091|Procedure|Post-extractive inter-radicular implant bed preparation|Implant placement in mandibular molars
15901218|NCT03640078|Other|acquisition imaging|The usual care of the sera will not be modified, only a phase of acquisition of the images will be added to the analysis
15901219|NCT03640065|Drug|freeze-dried probiotic sachets|"The participants will be instructed to consume the sachets as follow, each sachet powder is mixed with 10 ml of water in a measuring cup, then swish the mixture in the mouth for one minute before swallowing.
~This procedure will be repeated once daily for the following 4 weeks.
~4 weeks supply will be given to the participants."
15901220|NCT03640065|Dietary Supplement|fermented dairy product ( yogurt)|"The participants will be instructed to consume the yogurt once daily regularly for the following 4 weeks.
~4 weeks supply will be given to the participants with instruction to store the yogurt in refrigerator at home"
15901221|NCT03640052|Drug|Placebo oral capsule|Placebo capsule before sleep
15901222|NCT03640052|Drug|LTM1201L|LTM1201L capsule before sleep
15901223|NCT03640052|Drug|LTM1201LN|LTM1201LN capsule before sleep
15901224|NCT03640052|Drug|LTM1201LB|LTM1201LB capsule before sleep
15901225|NCT03640052|Drug|LTM1201LD|LTM1201LD capsule before sleep
15901226|NCT03640039|Procedure|3d strut plate.|Under general anathesia fracture will be exposed and fixed with 3d srut plate.Wound closed in standered fashion. patient will be released from operating room with out IMMF.
15901227|NCT03640026|Drug|Tacrolimus|Tacrolimus will be initiated at 0.1 mg/kg/day in two separate 12-hour oral doses (capsules) for 14 days.
15901228|NCT03640013|Procedure|Hall Technique PMC|Hall Technique primary fitted crowns to restore carious primary molars
15901229|NCT03640000|Diagnostic Test|Impedance measurements in Cardiac Resynchronization therapy|Bioimpedance measurements
15901230|NCT03639987|Drug|Aducanumab|Administered as specified in the treatment arm.
15901231|NCT03639987|Drug|Placebo|Administered as specified in the treatment arm.
15901232|NCT03639974|Other|PEP in a blow-bottle device|A 500-milliliter enteral nutrition vial will be used, which will contain a hole in the side, where two silicone tubes of 20 centimeters long will be inserted together with tape on the bottleneck of the vial. To perform the exercise, the vial will be filled with water leaving a water column of 10 cm high. Deep inspirations will be requested at a volume greater than the tidal volume and less than the total lung capacity that can be performed via nasal or oral, then with the mouth connected to the extensors, the patient will exhale slowly, avoiding to totally empty the lungs. The protocol will be executed twice a day, three sets of ten repetitions. The group will receive the conventional physiotherapy of the cardiac intensive care unit of the HCPA.
15901279|NCT03639675|Drug|Topical IOP-lowering drugs|A combination of at least 3 topical IOP-lowering drugs will be administered during a run-in phase before treatment and should be kept unchanged until IOP evaluation at Week 1, after which they may be reduced according to the investigator's opinion
15902347|NCT03631407|Drug|Vicriviroc|Vicriviroc tablets administered orally, QD at dose level 1 or 2.
15901233|NCT03639974|Other|EPAP|The Vital Signs ® EPAP kit will be used. Exercises will be performed in the bed, and as soon as the patient is released by the medical team to leave the bed, they can be performed in the sitting position or in orthostasis. For performing the exercise, the EPAP mask will be connected to the face of the patient. The expiratory pressure will be adjusted to 10cmH2O. Deep inspirations will be requested at a volume greater than the tidal volume and below the total lung capacity, then the patient will exhale slowly. The protocol will be executed twice a day, three sets of ten repetitions. The group will receive the conventional physiotherapy of the cardiac intensive care unit of the HCPA, as described in the conventional physiotherapy group.
15901234|NCT03639974|Other|conventional physiotherapy|Conventional physical therapy consists of ventilatory exercises, bronchial hygiene techniques, passive, active-assisted or active exercises for upper and lower limbs, and resisted lower limb exercises; stretching, cough and walking guidelines. Initially the exercises will be performed in the bed, as soon as this is withdrawn and the patient is released by the medical team to leave the bed, the progression of the exercises to be performed in the sitting position, orthostasis, and ambulation is performed, this usually occurs on the 2nd postoperative day, after the removal of the mediastinal drain . Under supervision of the physiotherapist, the protocol will be performed twice daily, two sets of ten repetitions.
15901235|NCT03639961|Behavioral|Integrated leading, managing and governing for results model|Integrated leading, managing and governing for results model is an intervention launched to improve institutional delivery.
15901236|NCT03639961|Behavioral|Traditional model|Traditional model is a health service delivery model already in place in the government health system.
15901237|NCT03639948|Drug|Carboplatin|Intravenous solution
15901238|NCT03639948|Drug|Docetaxel|Intravenous solution
15901239|NCT03639948|Drug|Pembrolizumab|Intravenous solution
15901240|NCT03639948|Drug|Pegfilgrastim|Injectable product
15901241|NCT03639935|Drug|Rucaparib|Rucaparib 600 mg PO BID days 1-28
15901242|NCT03639935|Drug|Nivolumab|Nivolumab 240 mg IV days 1 and 15
15901243|NCT03639922|Drug|Imatinib 400mg|2 tablets of Imatinib 400mg per day for 6 days
15901244|NCT03639922|Drug|Placebo Oral Tablet|2 tablets of placebo per day for 6 days
15901245|NCT03639909|Procedure|sweating function|Sweating dysfunction by Sudoscan
15901246|NCT03639909|Procedure|Cardiovascular function|Cardiovascular (CV) tests
15901247|NCT03639896|Drug|Dexmedetomidine|0.5μg/kg Dexmedetomidine as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/h and stopped 30 minutes before the surgery over.
15901248|NCT03639896|Drug|Saline|0.5μg/kg saline as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/h and stopped 30 minutes before the surgery over.
15901249|NCT03639883|Drug|AIV001|Intradermal injection
15901250|NCT03639870|Device|Model iS3 three-stent trabecular micro-bypass system|Provided in Arm/Group descriptions.
15901251|NCT03639857|Device|532nm laser|532nm laser will be used to treat the lesion in this study arm.
15901252|NCT03639857|Device|1064nm laser|1064nm laser will be used to treat the lesion in this study arm.
15901253|NCT03639857|Drug|Topical corticosteroid|The topical corticosteroid will be used to treat the lesion in this study arm.
15901254|NCT03639844|Biological|rivogenlecleucel|BPX-501 T cells are genetically modified with a suicide safety switch. The cells are infused after T cell-depleted HSCT to potentially enhance immune reconstitution while reducing severity and duration of GVHD.
15901255|NCT03639844|Drug|rimiducid|Rimiducid induces activation of the Caspase 9 suicide gene in BPX-501 T cells inducing apoptosis of the modified T cells in case of GVHD
15901256|NCT03639831|Dietary Supplement|Proprietary, standardized botanical extract|2 capsules/ day providing the proprietary botanical extract as unique active ingredient
15901257|NCT03639831|Dietary Supplement|Placebo (maltodextrin)|2 capsules/ day providing no active component
15901258|NCT03639818|Other|individual sessions of cognitive remediation|The cognitive remediation will be led by a psychologist specialized in neuropsychology, trained and experienced in this method. Cognitive remediation will be performed at a rate of 1 to 2 sessions per week for the duration of the study. This treatment will be carried out individually for half in face-to-face session in the clinical immuno-hematology department, face-to-face with the neuropsychologist, half at home with computer-based home exercises using PRESCO software ® from HAPPYNEURON®
15901259|NCT03639805|Other|Music therapy program MUSIC CARE® + standard care|Administration of a specific music therapy program (U method) delivered through headphones from an iPad, under the direction of trained nurses. The program will be proposed 3 times a day and will last 20 minutes at each session.
15901260|NCT03639805|Other|standard care of vaso-occlusive crises|administration of standard care only
15901261|NCT03639792|Procedure|gastric cancer surgery|Gastric cancer surgery
15901262|NCT03639779|Drug|Sodium Thiosulfate|A volume of 0.1 ml/cm2 of STS will be injected into each lesion.
15901263|NCT03639779|Other|Saline Solution|A volume of 0.1 ml/cm2 of normal saline will be injected into the control lesion.
15901264|NCT03639766|Drug|AbobotulinumtoxinA|AbobotulinumtoxinA reconstituted in non-bacteriostatic saline solution
15901265|NCT03639766|Other|Saline solution|Non-bacteriostatic saline solution
15901266|NCT03639753|Behavioral|Parent-Teen Intervention|Parent health coaching and resources + teen on-road driver experience + safe driving eLearning Modules
15901267|NCT03639753|Other|Usual Practice|Standard care for teens who get licensed in the state of PA
15901268|NCT03639740|Drug|Secukinumab 150 milligram [Cosentyx]|For intervention description: see arm/group description
15901269|NCT03639727|Diagnostic Test|Citric acid aerosol bronchial challenge|Inhalation challenge by citric acid aerosol to investigate the subject's cough sensitivity
15901270|NCT03639727|Diagnostic Test|Mannitol aerosol bronchial challenge|Inhalation challenge by mannitol aerosol to investigate the subject's cough sensitivity
15901271|NCT03639714|Biological|GRT-C901|a patient-specific neoantigen cancer vaccine prime
15901272|NCT03639714|Biological|GRT-R902|a patient-specific neoantigen cancer vaccine boost
15901273|NCT03639714|Biological|nivolumab|anti-PD-1 monoclonal antibody
15901274|NCT03639714|Biological|ipilimumab|anti-CTLA-4 monoclonal antibody
15902880|NCT03627234|Behavioral|Same Day Discharge|Patients will be randomized to same day discharge
15901280|NCT03639662|Other|sophrology sessions|"Patients benefit from additional support consisting of at least 3 sessions of sophrology, one per week, from the week following the announcement of the diagnosis and until the week preceding the hospitalization for irathérapie. It will be group sessions, 1h carried out in the participating center by a nurse sophrologist who will use the techniques of sophrology such as relaxation, breath control, mastery of thoughts and visualization. Each session will be recorded in digital format and the recording will be given to the patient at the end of the session so that he can, if he wishes, reproduce it at home.
~Patients will also be able to share their feelings and ask questions"
15901281|NCT03639649|Diagnostic Test|STHLM3|
15901282|NCT03639636|Other|non surgical and surgical periodontal therapy|scaling and root planing periodontal flap surgery
15901283|NCT03639623|Drug|Saroglitazar|Saroglitazar magnesium 4 mg tablet once daily (OD) in the morning 60 minutes before breakfast without food
15901284|NCT03639610|Drug|Melphalan flufenamide (melflufen)|intravenous infusion
15901285|NCT03639610|Drug|Dexamethasone|oral tablets
15901286|NCT03639597|Device|VytronUS Ablation System|
15901287|NCT03639571|Drug|Ibuprofen 200 mg TEPI Medicated Plaster|Ibuprofen 200 mg TEPI Medicated Plaster, manufactured by AdhexPharma, France on behalf of Medherant Ltd., UK
15901288|NCT03639571|Other|Placebo TEPI Plaster|Placebo TEPI Plaster, manufactured by AdhexPharma, France on behalf of Medherant Ltd., UK
15901289|NCT03639558|Drug|Haloperidol + Promethazine + Chlorpromazine|This is the usual treatment given by this hospital during an aggressive psychiatric episode.
15901290|NCT03639558|Drug|Haloperidol + Promethazine|This is the second most used psycho-pharmacological combination used in this hospital during an aggressive psychiatric episode.
15901291|NCT03639545|Drug|Empagliflozin 25mg|The patients receive empagliflozin (25 mg daily) for 12 weeks.
15901292|NCT03639545|Drug|Metformin|The patients receive metformin (2000 mg daily) for 12 weeks.
15901293|NCT03639545|Drug|Empagliflozin/Metformin|The patients receive empagliflozin 25 mg daily and metformin 2000 mg daily or placebo for 12 weeks.
15901294|NCT03639545|Drug|Placebos|The patients receive for 12 weeks.
15901295|NCT03639532|Procedure|COC THA|standard total hip arthroplasty is done, with ceramic on ceramic for the bearing.
15901296|NCT03639532|Procedure|COP THA|standard total hip arthroplasty is done, with ceramic on highly cross linked polyethylene for the bearing.
15901297|NCT03639519|Drug|Ascorbic Acid 500Mg Chew Tab|Ascorbic acid will be administered at the night before surgery and will be continued for five days
15901298|NCT03639519|Other|Carbonated orange beverage|The carbonated orange beverage will be administered at the night before surgery and will be continued for five days
15901299|NCT03639506|Procedure|autologous mitochondria transplantation|inject autologous mitochondria from bone marrow mesenchymal stem cells into oocyte
15901300|NCT03639506|Combination Product|autologous mitochondria from bone marrow mesenchymal stem cells into oocyte as well as intracytoplasmic sperm injection (ICSI)|autologous mitochondria transplantation
15901301|NCT03639506|Drug|intracytoplasmic sperm injection (ICSI)|intracytoplasmic sperm injection (ICSI)
15901302|NCT03639493|Drug|Exforge® tab 10/160mg, Crestor® tab 20mg|Co-administration of Amlodipine 10mg/ Valsartan 160mg(combination drug) and Rosuvastatin 20mg
15901303|NCT03639493|Drug|CJ-30060 10/160/20mg|Fixed-dose combination drug containing Amlodipine 10mg and Valsartan 160mg and Rosuvastatin 20mg
15901304|NCT03639480|Drug|Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg|Amlodipine 10mg+Valsartan 160mg+Atorvastatin 40mg
15901305|NCT03639480|Drug|Amlodipine 10mg+Valsartan 160mg|Amlodipine 10mg+Valsartan 160mg
15901306|NCT03639480|Drug|Valsartan 160mg+Atorvastatin 40mg|Valsartan 160mg+Atorvastatin 40mg
15901307|NCT03639467|Drug|Anlotinib plus gemcitabine/cisplatin|"In the phase Ib portion, patients received dose escalation of anlotinb (from 8mg to 12mg orally once daily on days 1-14 of a 21-day) in combination with fixed dose of gemcitabine (1000mg/m2 intravenously on days 1 and 8) and cisplatin (80mg/m2 intravenously on day 1) every 3 weeks.
~In the phase II portion, patients received anlotinb at recommended phase II dose determined in the phase Ib portion, in combination with fixed dose of gemcitabine and cisplatin every 3 weeks.
~The combination of anlotinib plus gemcitabine / cisplatin was repeated every 3 weeks for up to six cycles. Patients with disease control (defined as a complete response, a partial response, or stable disease) continue to receive anlotinb until disease progression or unacceptable toxic effects, whichever occurred first."
15901308|NCT03639454|Procedure|dry needling|Dry needling, also known as myofascial trigger point dry needling, is an well-proved technique in alternative medicine similar to acupuncture. It involves the use of either solid filiform needles or hollow-core hypodermic needles for therapy of muscle pain, including pain related to myofascial pain syndrome. Dry needling is sometimes also known as intramuscular stimulation (IMS).
15901309|NCT03639454|Procedure|Transcutaneous electrical nerve stimulation|"Transcutaneous electrical nerve stimulation (TENS or TNS) is the use of electric current produced by a device to stimulate the nerves for therapeutic purposes.
~TENS, by definition, covers the complete range of transcutaneously applied currents used for nerve excitation although the term is often used with a more restrictive intent, namely to describe the kind of pulses produced by portable stimulators used to treat pain. The unit is usually connected to the skin using two or more electrodes. A typical battery operated TENS unit is able to modulate pulse width, frequency and intensity. Generally TENS is applied at high frequency (>50 Hz) with an intensity below motor contraction (sensory intensity) or low frequency (<10 Hz) with an intensity that produces motor contraction."
15901310|NCT03639441|Procedure|dry needling|Dry needling, also known as myofascial trigger point dry needling, is an well-proved technique in alternative medicine similar to acupuncture. It involves the use of either solid filiform needles or hollow-core hypodermic needles for therapy of muscle pain, including pain related to myofascial pain syndrome. Dry needling is sometimes also known as intramuscular stimulation (IMS).
15901350|NCT03639116|Procedure|Stimulation|This study is a novel approach to studying neuroplasticity after stroke. Previous work in humans with incomplete spinal cord injury demonstrates that the resulting plasticity transiently enhances motor output, indicating that there is also therapeutic potential. This study will attempt to induce bi-directional plasticity in corticospinal-motoneuronal synapses serving an intrinsic hand muscle of the hemiparetic limb. Control experiments will be completed to provide evidence of the neurophysiological mechanism(s) mediating the effect and to examine behavioral effects.
15921328|NCT03487562|Drug|Amoxicillin|Amoxicillin 1 g
15901311|NCT03639441|Procedure|Transcutaneous electrical nerve stimulation|"Transcutaneous electrical nerve stimulation (TENS or TNS) is the use of electric current produced by a device to stimulate the nerves for therapeutic purposes.
~TENS, by definition, covers the complete range of transcutaneously applied currents used for nerve excitation although the term is often used with a more restrictive intent, namely to describe the kind of pulses produced by portable stimulators used to treat pain. The unit is usually connected to the skin using two or more electrodes. A typical battery operated TENS unit is able to modulate pulse width, frequency and intensity. Generally TENS is applied at high frequency (>50 Hz) with an intensity below motor contraction (sensory intensity) or low frequency (<10 Hz) with an intensity that produces motor contraction."
15901312|NCT03639428|Drug|Midazolam|All subjects received a sigle 0.3mg/kg midazolam dose os ADV6209
15901313|NCT03639415|Drug|Increasing the Controlled-Release Oxycodone dose frequency|Keep the daily dose while increase the dose frequency of Controlled-Release Oxycodone so that reduce the single dose
15901314|NCT03639402|Behavioral|Health education classes|Community empowerment through involvement of local mothers (peer mothers) for dissemination of education regarding health diet and physical activity to others eligible mothers in the community (fellow mothers).
15901315|NCT03639389|Drug|Bupivacaine|Spinal anesthesia with a combination of bupivacaine and fentanyl or sufentanil
15901316|NCT03639389|Drug|Analgesics|Combination of paracetamol + non-steroidal anti-inflammatory drug + morphine to all patients
15901317|NCT03639363|Drug|4% chlorhexidine gluconate soap-like solution|"humidify the whole body surface with the exception of the face using water-impregnated washcloths
~use 4% CHG-impregnated washcloths to bath the whole body surface with the exception of the face; use at least 30 ml of 4% CHG
~wait for at least 30 seconds
~rinse using water-impregnated washcloths"
15901318|NCT03639363|Other|standard soap|"humidify the whole body surface with the exception of the face using water-impregnated washcloths
~use standard soap-impregnated washcloths to bath the whole body surface with the exception of the face
~wait for at least 30 seconds
~rinse using water-impregnated washcloths"
15901319|NCT03639350|Behavioral|IER+MED group|Follow a Mediterranean diet 5 days per week and follow intermittent energy restriction 2 days per week.
15901320|NCT03639350|Behavioral|DASH group|Follow the distribution of macronutrients and food groups prescribed by the DASH diet 7 days per week.
15901321|NCT03639337|Dietary Supplement|Multi-strain probiotic|30 days of administration of multi-strain probiotics containing 3.5 x 109 UFC of Bifidobacterium longum BB536, Bifidobacterium breve M-16V and Bifidobacterium infantis M-63
15901328|NCT03639311|Drug|CAB LA|Administered CAB LA (600 mg) Q2M, as intramuscular injection.
15901329|NCT03639311|Drug|RPV LA|Administered RPV LA (900 mg), Q2M, as intramuscular injection.
15901330|NCT03639311|Drug|RPV|Oral dose of RPV 25 mg, administered once daily from Day 1 up to Month 12
15901331|NCT03639311|Drug|DTG|Oral dose of DTG 50 mg administered once daily from Day 1 up to Month 12.
15901332|NCT03639298|Device|Intendu|intensive training with Motion Based Cognitive Video Games Software
15901333|NCT03639272|Procedure|open reduction and internal fixation (ORIF).|Depending on the fracture location, a single anteromedial or anterolateral approach was carried out. The fracture site was cleaned to make it visible, allowing anatomical reduction. Subsequently, fixation of provisional fragments was achieved using temporary Kirschner wires under radiographic guidance. Having obtained satisfactory reduction as seen with the radiographic intensifier, definitive fixation of the main bone fragments was carried out using two or more 3.5 mm titanium cannulated screws or 4.0 mm lag screws, placed anteriorly to posteriorly. Fractures complicated by severe comminution necessitated 3.5 mm cortical screws in order to avoid shortening, translation or angulation of the fragments.
15901334|NCT03639246|Drug|AVB-S6-500|AVB-S6-500 is experimental drug
15901335|NCT03639246|Drug|Paclitaxel (Pac)|Paclitaxel is active comparator
15901336|NCT03639246|Drug|Pegylated liposomal doxorubicin (PLD)|PLD is active comparator
15901337|NCT03639246|Other|Placebo|Placebo comparator
15901338|NCT03639233|Behavioral|YESS!|Web based self-management education
15901339|NCT03639220|Device|Photobiomodulation Therapy (PBMT)|Phototherapy device - Multi Radiance Medical™ (Solon, OH, EUA)
15901340|NCT03639194|Drug|ABBV-011|Intravenous
15901341|NCT03639194|Drug|Budigalimab|Intravenous
15901342|NCT03639181|Biological|GB226|3mg/kg treat every 2 weeks
15901343|NCT03639168|Drug|Chidamide combined with cisplatin|Chidamide combined with cisplatin
15901344|NCT03639155|Drug|vadadustat reference tablets|oral tablet
15901345|NCT03639155|Drug|vadadustat test tablets|oral tablet
15901346|NCT03639142|Other|Prunus domestica|Patients will receive prunes at dose 3,5 g/kg/d (max.100mg/day) in three portions a day, for 4 weeks (amount of prescribed prunes will be calibrated with the weight that child ought to have on WHO growth charts at 50th percentile). Prunes should be introduced every day in three meals. Prunes can be chopped or grinded before eating them. They can be eaten alone or child may eat them as a part of bigger meal (which is preferred version). Prunes can be introduced with yogurt, cereals, nuts and seeds as a morning meal.
15901347|NCT03639142|Drug|Polyethylene Glycol 4000|Patients will receive PEG at dose 0,5 g/kg/d once daily orally, for 4 weeks.
15901348|NCT03639129|Device|Contrast-enhanced mammography|Contrast-enhanced mammography was FDA approved in 2012 and is currently being used in both clinical and research settings at breast imaging centers throughout the world
15901349|NCT03639129|Procedure|Biopsy|Standard of care
15901379|NCT03638843|Procedure|Gastric mucosal devitalization|Gastric mucosal devitalization is an endoscopic procedure which uses argon plasma coagulation to result in selective damage to the gastric mucosa and submucosa.
15902073|NCT03633591|Drug|Tolcapone Modified Release Prototype|A single dose of tolcapone modified release prototype in the fasted state
15901351|NCT03639103|Procedure|Distal Metatarsal Metaphyseal Osteotomy (DMMO)|The scalpel is advanced at an oblique angle of about 45° until it reaches the dorsal aspect of the distal metatarsal bone to undergo osteotomy. First a bone rasp specific for percutaneous surgery is used to separate the periosteum at the level of the osteotomy site. A Shannon Isham burr is introduced until it reaches the metatarsal neck where the periosteum was previously removed. Fluoroscopy is used to confirm the correct position of the osteotomy site. The lateral cortical surface is cut first, then the plantar, medial, and lastly, the dorsal cortical surface. During the osteotomy process, the incision site is irrigated by normal saline, as the burr can cause excessive heat, causing skin burn and resulting subsequently in fibrosis and pseudoarthrosis at the bone level.
15901352|NCT03639090|Diagnostic Test|mass spectrometry|mass spectrometry for bladder cancer cells
15901353|NCT03639077|Device|Allograft bone alone|The subject will receive an allograft as graft material of choice for sinus augmentation
15901354|NCT03639077|Device|Allograft and xenograft mixture|The subjects will receive a mixture of allograft and anorganic bovine bone xenograft as graft material of choice for sinus augmentation
15901355|NCT03639064|Drug|Cannabis Oil|"Mixed oil cannabis preparation consisting of 3 differing formulations of ∆-9THC and CBD is clinically available in Canada as CanniMed®. The 3 differing formulations of CanniMed® oils contain varying proportions of ∆-9THC and CBD in the following ratios: 18:0; 10:10; 1:20.
~All CanniMed® oil formulations consist of cannabinoids extracted from dried cannabis, and diluted in olive oil."
15901356|NCT03639051|Device|Targeted Lung Denervation (TLD)|Targeted Lung Denervation (TLD) Therapy is a bronchoscopically guided, minimally invasive procedure using the Nuvaira™ Lung Denervation System.
15901357|NCT03639051|Other|Optimal Medical Care|Taking regular maintenance medication that minimally includes a long-acting muscarinic antagonist (LAMA) and a long-acting beta2-agonist (LABA).
15901358|NCT03639025|Device|OCS Lung System|"The OCS™ Lung System is a portable organ perfusion, ventilation, and monitoring medical device intended to preserve donor lungs in a near physiologic, ventilated, and perfused state prior to transplantation. This technology was designed to overcome the limitation of cold storage and has the potential to expand the utilization of donor lungs. The OCS™ Lung System accomplishes this by performing 3 key functions:
~Reducing ischemic injury through the use of warm, oxygenated blood based perfusion.
~Optimizing the lung condition by ventilatory recruitment maneuvers and high-oncotic perfusion solution supplemented with hormones and nutrients.
~Allowing for ex-vivo functional assessment of the donor lung during preservation and prior to transplant."
15901359|NCT03639012|Dietary Supplement|Carbohydrate drink|Children randomised to this group will receive a preoperative carbohydrate drink 90-120mins prior to surgery
15901360|NCT03638999|Drug|Ketorolac Trometamol 30Mg/1mL Injection|Subjects in the intervention group will receive intravenous injection of 1 ml of Ketorlac 30 mg/ml prior to the start of the ureteroscopic procedure.
15901361|NCT03638999|Drug|Normal saline|Subjects in the control group will receive 1 ml of 0.9% injectable normal saline prior to the start of the ureteroscopic procedure.
15901362|NCT03638986|Other|No intervention planned|No Intervention planned.
15901363|NCT03638973|Procedure|Biopsy|Removal of specimen biopsies in patients with leukoplakic or lichenoid mucosal lesions using Er: YAG laser or scalpel under previous local anesthesia.
15901364|NCT03638960|Drug|Bupivacaine liposome|The investigators will perform an ultrasound-guided interscalene peripheral nerve block with either liposomal bupivacaine prior to the patient receiving surgery.
15901365|NCT03638960|Drug|Bupivacaine Hydrochloride|The investigators will perform an ultrasound-guided interscalene peripheral nerve block with either plain bupivacaine prior to the patient receiving surgery.
15901366|NCT03638947|Device|Swab and decolonization using povidone-iodine cleansing|Patient in this group will receive improved environmental cleaning and undergo surveillance using swabs and decolonization cleansing.
15901367|NCT03638934|Other|Videos about ACP|Three videos about advanced care planning are provided for self-education.
15901368|NCT03638934|Other|Brochure about Life-Sustaining Treatment Act|Brochure about Life-Sustaining Treatment Act are provided for self-education.
15901369|NCT03638921|Drug|MEOPA|Patients included in the study will receive MEOPA with a high concentration mask (bottle stored for at least 48 hours horizontally) at a minimum flow rate of 10 L / min under supervision of a health care worker after explanation of use to the patient in a quiet environment (box). MEOPA will be administered for a maximum total duration of 20 minutes, continuously or not depending on the needs of the patient, but after a continuous phase at the beginning of treatment of at least 3 minutes.
15901370|NCT03638908|Drug|Fluoxetine|
15901371|NCT03638895|Device|ECAL Indirect Calorimeter|The ECAL is an open-circuit portable indirect calorimeter that measures both volume of CO2 expired and O2 consumed using a small mixing chamber. Participants will breathe through a mouthpiece with a nose clip applied whilst lying in a restful and comfortable position for 15 minutes. ECAL device will provide breath-by-breath measurements of the resting energy expenditure and respiratory quotient which will allow both practitioners and participants to monitor their metabolic health and compare the effect of dietary and physical activity intervention over the course of the structured intensive lifestyle intervention (24-weeks).
15901372|NCT03638895|Behavioral|Diet, exercise & behaviour modification therapy|Standard care (SC) - participants receive standard care (diet, exercise & behaviour modification therapy) as part of the multicomponent weight management intervention within the tier 3 weight management service. Practitioners will rely on standard predictive equations to provide dietary advice and intervention.
15901373|NCT03638882|Behavioral|Duolingo|Will learn Spanish using the commercially available Duolingo application. It is a computerized language training program.
15901374|NCT03638882|Behavioral|BrainHQ|Will use the commercially available Posit Science product Brain HQ. Brain HQ is a computerized adaptive cognitive brain training program.
15901375|NCT03638882|Behavioral|Passive Control|No Intervention.
15901376|NCT03638869|Drug|REL-1017|The investigational product, REL-1017 is prepared as a solution with Ocean Spray® Diet Cranberry Juice on site to obtain a final volume of 100 mL for dosing. The study drug will be administered as a solution of 25 mg, 50 or 75 mg REL-1017 for 10 days, based on randomization prepared in Ocean Spray® Diet Cranberry Juice with a final volume of 100 mL.
15901377|NCT03638869|Drug|Placebo|
15901378|NCT03638856|Drug|Misoprostol 200Mcg Tab|patient takes 2 tab of 200 mcg of Misoprostal 3 hr before hysteroscopy
15921329|NCT03487562|Drug|Lansoprazole|Lansoprazole 30 mg
15901380|NCT03638830|Drug|Ftortiazinon (tablets 300 mg) 1/2 dose +placebo+ Maxipim|"Ftortiazinon tablets 300 mg (FSBI N.F. Gamaleya NRCEM of the Ministry of Health of the Russian Federation)+placebo"
15901381|NCT03638830|Drug|Ftortiazinon (tablets 300 mg) full dose + Maxipim|"Ftortiazinon tablets 300 mg (FSBI N.F. Gamaleya NRCEM of the Ministry of Health of the Russian Federation)"
15901382|NCT03638830|Other|placebo+Maxipim|placebo
15901383|NCT03638817|Drug|Eltrombopag|"Eltrombopag will be prescribed at doses recommended in primary immune thrombocytopenia (50, 25 or 75 mg), starting 4 weeks before the procedure and stopped 2 days before. PC will be administrated prophylactically if the platelet count is < 80 G/L or per/post-operatively in case of bleeding of undetermined cause.
~Antifibrinolytics will be authorized and low molecular weight heparin prescribed if indicated for the prophylaxis of postoperative venous thrombosis according to the standard dose and duration, , irrespective of the platelet count"
15901384|NCT03638804|Diagnostic Test|89Zr-KN035|Single injection of 89Zr labeled KN035 in subjects to observe KN035 affinity in PD-L1 expressed Solid tumors by using PET imaging.
15901385|NCT03638791|Behavioral|Exposure and response inhibition|Cognitive behavioural therapy designed for treatment of Obsessive-compulsive disorder
15901386|NCT03638778|Drug|Semaglutide 3 mg|Semaglutide 3 mg will be administered once daily (OD) orally in the morning from day 1 to 5.
15901387|NCT03638778|Drug|Semaglutide 7 mg|Semaglutide 7 mg will be administered OD orally in the morning from day 6 to 10.
15901388|NCT03638778|Drug|Semaglutide B 3 mg|Semaglutide B 3 mg will be administered OD orally in the morning from day 1 to 5.
15901389|NCT03638778|Drug|Semaglutide B 7 mg|Semaglutide B 7 mg will be administered OD orally in the morning from day 6 to 10.
15901390|NCT03638778|Drug|Semaglutide C 3 mg|Semaglutide C 3 mg will be administered OD orally in the morning from day 1 to 5.
15901391|NCT03638778|Drug|Semaglutide C 7 mg|Semaglutide C 7 mg will be administered OD orally in the morning from day 6 to 10.
15901392|NCT03638778|Drug|Semaglutide D 3 mg|Semaglutide D 3 mg will be administered OD orally in the morning from day 1 to 5.
15901393|NCT03638778|Drug|Semaglutide D 7 mg|Semaglutide D 7 mg will be administered OD orally in the morning from day 6 to 10.
15901394|NCT03638765|Biological|DCVax-Direct|activated, autologous dendritic cells
15901395|NCT03638752|Other|Comprehensive education group|"The details of Comprehensive education are as follows:
~introduce the purpose, method and function of breathing training and the whole process of gastroscopy;
~instruct patients to take deep breath training, inhaling with his/her nose and exhaling with his/her mouth,
~provide patients with a disposable dental biting device and repeat exercising deep breathing again until he/she is fully mastered,
~inform patients to cooperate with the instructions issued by endoscopist and endoscopy nurse during the whole process of gastroscopy,
~inform patients to inhale with nose and exhale with mouth when the gastroscope passes through the throat, then he/she should perform inhaling and exhaling with his/her nose until the end of the gastroscopy when the endoscopist ask to adjust the breathing method,
~inform patients that there would be some normal physiological reaction when gastroscopy, such as throat discomfort and nausea/vomiting."
15901396|NCT03638739|Other|Twice-weekly exercise|An individualized exercise plan, incorporating aerobic and resistance exercises, following the Physical Activity Guideline recommendations will be provided for each participant.
15901397|NCT03638726|Drug|Atropine sulfate and epinephrine|Experimental arm:Combined use of subconjunctival atropine sulfate 0.6 mg ( parasympathetic antagonist) and intracameral epinephrine 1:100000 ( sympathetic agonist). Control arm :topical mydriatics are used for pupil dilation.
15901398|NCT03638726|Drug|Topical cyclopentolate and phenylephrine|Control arm: Preoperative cyclopentolate and phenylephrine eye drops are used.
15901399|NCT03638713|Behavioral|colonoscopy first|Received water exchange colonoscopy followed by EGD
15901400|NCT03638713|Behavioral|EGD first|Received EGD followed by water exchange colonoscopy
15901401|NCT03638700|Device|VisiGlide™ angled tip|Arm A: Primary use of VisiGlide™ guidewire (angled tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide™ (straight tip) resp. to VisiGlid2e™ (tip according to the examiner)
15901402|NCT03638700|Device|VisiGlide2™ angled tip|Arm B: Primary use of VisiGlide2™ guidewire (angled tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide2™ (straight tip) resp. to VisiGlide™ (tip according to the examiner)
15901403|NCT03638700|Device|VisiGlide™ straight tip|Arm C: Primary use of VisiGlide™ guidewire (straight tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide™ (angled tip) resp. to VisiGlide2™ (tip according to the examiner)
15901404|NCT03638700|Device|VisiGlide2™ straight tip|Arm D: Primary use of VisiGlide2™ guidewire (straight tip). In case it should not be possible to complete one step toward the therapeutic goal after 8 to max. 12 minutes after start of the examination, the wire system is changed: primary change to VisiGlide2™ (angled tip) resp. to VisiGlide1™ (tip according to the examiner)
15901405|NCT03638674|Other|DXA + CT|Two dual-energy X-ray scans + CT scan
15901406|NCT03638661|Dietary Supplement|vegetable (canola, flaxseed) derived n-3 fatty acid|vegetable (canola, flaxseed) derived n-3 fatty acid was used for fat source.
15901407|NCT03638661|Dietary Supplement|soybean oil|soybean oil used formula
15901408|NCT03638648|Drug|Capecitabine|Capecitabine 2500mg/m2/day, d1-d14, every 3 weeks a cycle for 8 cycles
15901409|NCT03638635|Drug|Bupivacaine|Abdominal injection of bupivacaine into fascial layer.
15901410|NCT03638635|Drug|Bupivacaine liposome|Abdominal injection of bupivacaine liposome into fascial layer.
15901411|NCT03638622|Combination Product|Photodynamic Therapy|Patients receive aminolevulinic acid (ALA) orally with orange juice in 3 fractions at 0,1,2 hours before undergoing photodynamic therapy using LED based Device on day one.
15901440|NCT03638310|Procedure|intratympanic application of gentamicin|under local anesthesia is gentamicin instilled through tympanic membrane to tympanic cavity
15901441|NCT03638310|Procedure|microsurgical removal of vestibular schwannoma|surgery under general anesthesia
15901481|NCT03637972|Other|Unventilated cigarettes only|Participants given vouchers that are exchanged for unventilated cigarettes study cigarettes.
15901412|NCT03638609|Device|Intra Aortic Balloon Pump|"Intra Aortic Balloon Pump (IABP) is a circulatory mechanical support device, placed in descending aorta, distally from left subclavian artery and proximally from renal artery. IABP works with counterpulsation concept, synchronized with heart cycle. It is indicated as supportive therapy for patients undergoing revascularization, cardiogenic shock and mechanical complication.
~Balloon dilatation during dyastolic phase increasing dyastolic pressure in aorta, improving coronary vascularization and myocardial oxygen supply. In systolic phase, the balloon deflates, reducing the left ventricle afterload hence decreasing myocardial oxygen demand."
15901413|NCT03638596|Behavioral|Contingency Management|Incentive provided for changing alcohol drinking patterns based on ankle monitor
15901414|NCT03638596|Behavioral|Control|Incentive provided is not contingent on alcohol drinking patterns based on ankle monitor
15901415|NCT03638557|Other|Nutritious Lunch|"The intervention package consists of the following;
~Balanced Nutrition and Clean and Healthy Lifestyle Behavior Education for the boarding school students (once a week with the duration of 30-60 minutes. 3 weeks are delivered by trained teachers, and 1 week by research team.
~Nutritious lunch, for 7 days a week. With the total of 220 days. The lunch menu is designed to meet 30% of the students RDA, which consists of 635-777 Kcal and 18-22 grams of protein"
15901416|NCT03638544|Dietary Supplement|Reduced gluten bread and Pasta compared o normal gluten bread and Pasta|Pasta with low gluten (50% of the normal) content achieved by optimization of techological parameters such as dough yield, time of fermentation and concentration of fungal proteases The gluten reduction is obtained without any other intervention of wheat breeding or the endogenous proteolytic enzymes of flours.
15901417|NCT03638531|Device|Anodal tDCS|Anodal tDCS will be applied over the FDI muscle representational area of the motor cortex for 25 minutes in combination with the two motor tasks (precision grip task and handwriting task).
15901418|NCT03638531|Device|SHAM tDCS|SHAM tDCS will be applied over the FDI muscle representational area of the motor cortex for 25 minutes in combination with the two motor tasks (precision grip task and handwriting task).
15901419|NCT03638518|Other|Acupuncture|Acupuncture 5 weeks treatment. 2 sessions a week (30 minutes each session)
15901420|NCT03638518|Other|Physiotherapy|Core stability exercises programme. 2 sessions a week (30 minutes each session) during 5 weeks
15901421|NCT03638505|Other|PSP-QoL|"PSP-QoL is a patient-reported outcome measure for progressive supranuclear palsy (PSP). The Supranuclear Palsy Quality of Life scale (PSP-QoL) may be a helpful patient-reported scale for clinical trials and studies in PSP.
~PSP-QoL consists of 28 items scored on a 3- or 5-point Likert scale, with the total score ranging from 0 to 100. Each item is scored from either 0 to 4, with the exception of four items, which are scored from 0 to 2, with higher scores indicating more-severe disability or movement abnormality. Items are in six categories: daily activities (by history); behavior; bulbar; ocular motor; limb motor; and gait/midline. The scale includes comments and/or instructions for each item and word anchors to explain the ratings."
15901422|NCT03638492|Procedure|2-cm margin|Patients with CMM treated with a surgical safety margin of 2-cm in the surrounding skin and down to the fascia.
15901423|NCT03638492|Procedure|4-cm margin|Patients with CMM treated with a surgical safety margin of 4-cm in the surrounding skin and down to the fascia.
15901424|NCT03638479|Other|Data Capture|This is no intervention. Participants of all groups will receive data Capture with smartphones, smartwatches and tablets.
15901425|NCT03638466|Drug|SPN-810|Single dose of SPN-810
15901426|NCT03638466|Drug|Placebo|Placebo
15901427|NCT03638453|Other|PediCARE|PediCARE provides support for groceries (using an online grocery delivery service called Instacart) and transportation to and from the hospital (using rides through RideHealth).
15901428|NCT03638453|Other|Usual Care|Standard care per hospital guidelines.
15901429|NCT03638440|Drug|Naloxegol|Naloxegol is a PEGylated derivative of the μ-opioid receptor antagonist naloxone
15901430|NCT03638427|Diagnostic Test|Menstrual Blood Analysis (Menstrual Blood Analysis)|We will be testing women's menstrual blood to investigate the feasibility and efficacy of assessing HR-HPV DNA and HPV E6/E7 mRNA via self-collected menstrual blood from a menstrual pad.
15901431|NCT03638414|Other|ePainQ questionnaire|This is a questionnaire which will be given to the intervention group about their perceptions of treatment. It will be online.
15901432|NCT03638401|Procedure|This arm will received perioperative transversus abdominis plane (TAP) block followed by continuous infusion of local anaestheic by wound catheters and an IV morphine PCA.|This arm will received perioperative transversus abdominis plane (TAP) block followed by continuous infusion of local anaestheic by wound catheters and an IV morphine PCA.
15901433|NCT03638388|Procedure|Dry needling (DN)|One to three filament needles (similar to an acupuncture needle) with no medication will be inserted into the tender area of my muscle. The needles will be repositioned a few times to make the muscle twitch. After several twitches occur, the researcher will leave the needles as they are, and the subject will sit in a chair without moving my arms or head, for 10 minutes. After 10 minutes the needles are removed and discarded.
15901434|NCT03638388|Procedure|Dry needling with intramuscular electrical stimulation (DNES)|One to three filament needles (similar to an acupuncture needle) with no medication will be inserted into the tender area of the muscle. The needles will be repositioned a few times to make the muscle twitch. After several twitches occur, the researcher will leave the needles as they are, and attach alligator clips to the needles to provide electrical stimulus for 10 minutes while the subject sits in a chair without moving arms or head. After 10 minutes, the electrical stimulus will be turned off and detached, and the needles removed and discarded.
15901435|NCT03638375|Drug|Nivolumab & Tumor Infiltrating Lymphocytes with/without Interferon-Alpha|"During 15 weeks patients will be treated with nivolumab (3mg/kg i.v.) once every two weeks. Four weeks after starting nivolumab, patients will receive their first TIL infusion (2.5-7.5x10^8 T cells i.v.) once every three weeks for three infusions.
~In the second group treatment with IFN-alpha (3 million IU s.c.) daily will be added one week before the first TIL infusion and will be continued for 11 weeks."
15901436|NCT03638362|Dietary Supplement|Placebo|Participants consumed placebo beverage for 4 weeks.
15901437|NCT03638362|Dietary Supplement|Tart cherry juice|Participants consumed tart cherry juice (8 ounces; 240 mL) per day for four weeks.
15901438|NCT03638336|Device|ILY robotic flexible ureteroscopy|fragmentation of nephrolithiasis
15901439|NCT03638323|Other|Speech therapy|During a 1-hour speech-language consultation, a lack of word evaluation will be conducted and patient will answer a Hearing Difficulty Questionnaire
15901442|NCT03638297|Drug|PD-1 antibody + cox inhibitor|"BAT1306 100mg /pembrolizumab 200mg on day 1 + aspirin 200mg oral (celebrex 400mg oral when there is contraindication to aspirin) on day 1-21 every three weeks
~Contraindication to aspirin :
~Allergic or intolerance to aspirin; With peptic ulcers; With hemophilia or other bleeding tendencies; Have the gentic disease glucose-6 phosphate dehydrogenase deficiency."
15901443|NCT03638284|Device|Transcranial Direct Current Stimulation|tDCS is a non-invasive brain stimulation that does not require general anaesthesia or surgical implantation of a device. It uses two AA size batteries to deliver direct current via rubber electrodes enclosed in saline soaked sponges.
15901444|NCT03638271|Diagnostic Test|Cardiac magnetic resonance imaging|Patients in different sex and age groups diagnosed with any type of nonischemic cardiomyopathy clinically or with echocardiography will undergo cardiac magnetic resonance imaging and compare their results.
15901445|NCT03638258|Drug|ARQ-151 Cream 0.3%|Applied once daily for 12 weeks
15901446|NCT03638258|Drug|ARQ-151 Cream 0.15%|Applied once daily for 12 weeks
15901447|NCT03638258|Drug|ARQ-151 vehicle cream|Applied once daily for 12 weeks
15901448|NCT03638232|Other|Administrative data|Gender Birthdate Department and town of residence Date of death Affiliation to french Universal Health Coverage
15901449|NCT03638232|Other|Medical data|Long term affection code, number and medical codification Date of onset and end of care Codification of medical acts and consultation (With common classification of medical acts)
15901450|NCT03638232|Other|Drug exposition data|Speciality of prescribing physician CIP code of drug Name of speciality prescribed Date of deliverance Date of prescription Number of treatment box delivered
15901451|NCT03638219|Other|Data collection about eligible patients presented to our department from 2015 to 2018. Then follow up till 2020.|Data collection, follow up and bioscore calculation at the end of study
15901452|NCT03638206|Biological|CAR-T cell immunotherapy|According to tumor burden and other conditions, patients will be treated with cyclophosphamide or fludarabine,then,CAR-T cells will be infused 48-72 hours later.
15901453|NCT03638193|Biological|CART-meso cells|CART-meso is a 2nd CAR, with mesothelin as target protein, 4-1BB as co- stimulator. The infusion will be scheduled to occur 3 (±1) days after a single dose of 1.5 grams/m^2 of cyclophosphamide, which will be administered according to standard procedures, Thereby enhancing the efficacy of anti-tumor, reducing the potential of side effects.
15901454|NCT03638180|Drug|BLU-5937|BLU-5937 oral tablet
15901455|NCT03638180|Drug|Placebo|Matching placebo to BLU-5937
15901456|NCT03638167|Biological|EGFR806-specific chimeric antigen receptor (CAR) T cell|Autologous CD4+ and CD8+ T cells lentivirally transduced to express an EGFR806 specific chimeric antigen receptor (CAR) and EGFRt given via indwelling central nervous system (CNS) catheter
15901457|NCT03638154|Procedure|GF+GMSCs carried on β TCP|"surgical augmentation of GF+GMSCs carried on β TCP in intrabony periodontal defect and covered by collagen membrane(Bioresorb, Sybron, implant solutions GmbH Bremen, Germany) Cytoplast, RTM Collagen Cytoplast, Barrier Membranes, Osteogenics Biomedical, New Gersey, USA).
~Ibuprofen"
15901458|NCT03638154|Procedure|β TCP bone substitute only|surgical augmentation by β TCP in intrabony periodontal defect(Bioresorb, Sybron, implant solutions GmbH Bremen, Germany) Ibuprofen
15901459|NCT03638141|Drug|Durvalumab|Durvalumab IV
15901460|NCT03638141|Drug|Tremelimumab (Cohort A dose)|Tremelimumab IV
15901461|NCT03638141|Drug|Tremelimumab (Cohort B dose)|Tremelimumab IV
15901462|NCT03638128|Drug|Denosumab|clear, colorless to slightly yellow, preservative free liquid, in single-use 3.0 mL glass vials containing a deliverable dose of 120mg/1.7 mL (70 mg/mL).
15901463|NCT03638128|Other|No treatment|No treatment administered for off-treatment observation.
15901464|NCT03638128|Drug|Alternative osteoporosis medications|Alternative osteoporosis medication/s at the discretion of the investigator.
15901465|NCT03638115|Device|VaSecure™|Drug Coated PTA Balloon Catheter
15901466|NCT03638102|Behavioral|Sleep extension|Sleep extension aims to increase sleep duration for at least 30 minutes using weekly coaching
15901467|NCT03638102|Behavioral|Healthy living|Participants will receive weekly health education
15901468|NCT03638089|Behavioral|Fall-recovery training|Participants practice recovering from simulated, treadmill-induced slips and trips.
15901469|NCT03638076|Drug|GLS4|Subject in group A will receive Mesilate Capsule 120mg twice daily. Subject in group B will receive Mesilate Capsule 120mg three times daily.
15901470|NCT03638076|Drug|RTV|Subject in group A will receive Ritonavir tablet 100mg twice daily.Subject in group B will receive Ritonavir tablet 100mg three times daily.
15901471|NCT03638063|Diagnostic Test|Adenosine Triphosphate|Adenosine Triphosphate aerosol
15901472|NCT03638063|Diagnostic Test|capsaicin|capsaicin aerosol
15901473|NCT03638050|Other|Functional Capacity Assessment|Individuals will be assessed on the third day after acute myocardial infarction. The six-minute walk test will be performed according to the norms of the American Thoracic Society.
15901474|NCT03638037|Diagnostic Test|Vitamin D measurement|Maternal serum 25- hydroxyl vitamin D level
15901475|NCT03638024|Diagnostic Test|Maternal plasma cell free fetal DNA levels|Measurement Maternal plasma cell free fetal DNA levels in both groups (study and control groups)
15901476|NCT03638011|Drug|Exparel|Bilateral TAP Blocks with combination of regular Bupivacaine and EXPAREL
15901477|NCT03637998|Behavioral|Problem-solving Pain to Enhance Living Well (PROPEL)|PROPEL incorporates evidence-based, standard of care methods to promote physical activity among individuals with pain, and tools to improve knowledge, skills and confidence to cope with cLBP. The focus is self-management of cLBP. All eligible participants will then undergo baseline data collection, which entails completion of study questionnaires, quantitative sensory testing (QST) and venipuncture for collection of a blood specimen. Participants will be provided with the information to access the PROPEL intervention. All participants will be asked to complete questionnaires at 2, 4, 6, 8, and 10 weeks following baseline testing. At 12 weeks, participants will be scheduled for a final data collection visit, which will follow the same procedures as the baseline visit.
15901478|NCT03637985|Device|resistive exercise|resistive exercise by elastic band for 12 weeks
15901479|NCT03637985|Device|aerobic exercise in form of treadmill walking|aerobic exercise in form of treadmill walking for 12 weeks
15901480|NCT03637972|Other|Ventilated cigarettes only|Participants given vouchers that are exchanged for ventilated cigarettes study cigarettes.
15901482|NCT03637972|Other|Access to Experimental Marketplace: Ventilated cigarettes + alternative nicotine delivery systems|Participants given vouchers that are exchanged for ventilated cigarettes + alternative nicotine delivery systems cigarettes.
15901483|NCT03637972|Other|Access to Experimental Marketplace: Unventilated cigarettes + ANDS|Participants given vouchers that are exchanged for unventilated cigarettes + ANDS.
15901484|NCT03637959|Device|Mechanical Vibrations with Ultrasound Shear Wave Imaging|Measuring liver tissue density during mechanical liver tissue vibration.
15901485|NCT03637946|Other|Device: SHOFU beautifil II LS|Restorative system FL-Bond II (self-etching adhesive system)/ beautifil II (composite restorative) were used following manufacturer's instructions
15901486|NCT03637933|Procedure|endoscopic tattooing|The tattoo has to be placed 1 or 2 cm distal to the lesion and tattooing has to be performed in at least 2 of the 4 quadrants of the bowel. A 0.5-1 mL saline bleb has to be raised submucosally and then a similar quantity of India Ink or Sterile Carbon Particle Suspension has to be injectiected into that bleb.
15901487|NCT03637907|Other|Not applicable - no intervention.|No intervention is performed, just a CT with a new detector and comparison with the same patients older image.
15901488|NCT03637894|Dietary Supplement|Feeding infants with fermented formula milk|Infants enrolled were fed either with fermented formula milk or with standard formula during the first four months of life. Breastfed infants were the reference group.
15901489|NCT03637894|Other|Feeding infants with standard formula milk|Infants enrolled were fed either with fermented formula milk or with standard formula during the first four months of life. Breastfed infants were the reference group.
15901490|NCT03637894|Other|Breastfeeding infants|Reference group
15901491|NCT03637868|Drug|Eribulin|Patients will receive eribulin 1.4 mg/m² administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
15901492|NCT03637842|Drug|Lorcaserin|Lorcaserin XR 20mg per day
15901493|NCT03637842|Drug|Placebo oral capsule|Placebo
15901494|NCT03637829|Other|Control|Water
15901495|NCT03637829|Other|White chocolate|Experimental snack treatment
15901496|NCT03637829|Other|Dark chocolate 1|Experimental snack treatment
15901497|NCT03637829|Other|Dark chocolate 2|Experimental snack treatment
15901498|NCT03637816|Drug|Anamorelin Hydrochloride|Given PO
15901499|NCT03637816|Other|Placebo|Given PO
15901500|NCT03637816|Other|Questionnaire Administration|Ancillary studies
15901501|NCT03637803|Drug|MRx0518|MRx0518 is a live biotherapeutic product consisting of a lyophilised formulation of a proprietary strain of bacterium. The study dosing regimen is one capsule two times per day for the duration of the treatment period.
15901502|NCT03637803|Drug|Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]|Pembrolizumab is a potent humanised immunoglobulin G4 (IgG4) monoclonal antibody (mAb) with high specificity of binding to the programmed cell death 1 (PD1) receptor , thus inhibiting its interaction with programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). The study dosing regimen is 200mg (two 4ml vials of 25mg/ml solution) for IV infusion once every three weeks.
15901503|NCT03637790|Drug|PF-04965842|single oral 200 mg dose of PF 04965842 in the morning on Day 1 under fasted conditions.In Period 2, subjects will receive rifampin 600 mg QD in the mornings of Day 1 to Day 7, approximately 1 hour before the morning meal. On the morning of Day 8, after an overnight fast of approximately 9 hours, subjects will be administered rifampin 600 mg 1 hour prior to administration of a single 200 mg oral dose of PF 04965842.
15901504|NCT03637790|Other|rifampin|In Period 2, subjects will receive rifampin 600 mg QD in the mornings of Day 1 to Day 7, approximately 1 hour before the morning meal. On the morning of Day 8, after an overnight fast of approximately 9 hours, subjects will be administered rifampin 600 mg 1 hour prior to administration of a single 200 mg oral dose of PF 04965842
15901505|NCT03637777|Diagnostic Test|16S rRNA gene sequencing|Specimens collected from patients will be used for next generation sequencing of the bacteria-specific 16S rRNA gene
15901508|NCT03637751|Behavioral|Behavioral|Trier Social Stress Test
15901509|NCT03637751|Behavioral|Control condition|In the no-stress control condition, participants will be instructed to sit in a room, read magazines, and to refrain from any stressful activities (e.g., cell-phone use will be restricted).
15901510|NCT03637738|Radiation|RIOP-Intrabeam® system|The radiation source is inserted at the immediately on surgical resection bed after tumorectomy and started for 20 to 55 minutes to perform intraoperative radiotherapy precisely targeting the tissues that present the greatest risk of local recurrence. The applied dose will be 20 Gy on the applicator surface.
15901511|NCT03637738|Radiation|conventional surgery +RTE|Conventional EBRT, 5 to 10 weeks after surgery, according to the usual recommendations, 2 Gy per session, 5 sessions per week, with a total dose on the mammary gland of 50 Gy + a boost of 16 Gy on surgical resection bed .
15901512|NCT03637712|Device|Computer Algorithm|This device is a computer algorithm that runs in the background during routine screening or surveillance colonoscopy that is designed to aid in the detection of polyps
15901513|NCT03637699|Behavioral|Positive Psychology|5-week positive psychology intervention
15901514|NCT03637673|Other|No intervention|No intervention
15901516|NCT03637647|Diagnostic Test|Cardiopulmonary exercise testing|The CPET involves cycling on an exercise bike for 8-12 minutes. Starting with a very low resistance on the pedals the patient will pedal at 60 revolutions per minute. After 3 minutes of cycling, the resistance will gradually increase until the patient can no longer turn the pedals at the required speed. The test will be thoroughly explained to the patient beforehand and trained staff will make the experience as comfortable as possible. CPETs will be stopped early by the study researcher/doctor in the presence of any adverse events. Each CPET appointment will last approximately one hour.
15901517|NCT03637621|Other|ORIF|open reduction internal fixation of the distal humerus
15901518|NCT03637595|Procedure|Acupuncture|3 sessions of acupuncture will be the reference therapy against which the energy medicine intervention is being compared.
15902881|NCT03627234|Behavioral|Overnight Stay|Patients will be randomized to stay overnight
15901519|NCT03637595|Procedure|Enery Medicine Intervention|3 sessions performed by Energy Medicine practitioner, who will perform an assessment followed by the intervention.
15901520|NCT03637595|Procedure|Sham Energy Medicine|a non-energy trained confederate to be determined from the clinical research coordinators and non traditional volunteers enrolled administering assessments and providing therapeutic company.
15901521|NCT03637582|Drug|lidocaine gel|Lidocaine (4%) gel from Quest Products, Inc.
15901522|NCT03637582|Other|Plain aqueous gel|KY jelly lubricant from Reckitt Benckiser
15901523|NCT03637569|Other|Measurement of triceps skinfold thickness|By using skin thickness caliper, measure triceps skinfold thickness on the half of forearm (Rt side). In every 3 weeks, triceps skinfold thickness will be measured.
15901524|NCT03637556|Drug|DST-0509|Novel iron chelator with improved absorption characteristics
15901525|NCT03637556|Drug|Jadenu|Commercial iron chelator with standard absorption characteristics
15901526|NCT03637556|Drug|Exjade|Commercial iron chelator with standard absorption characteristics
15901527|NCT03637543|Drug|Nivolumab|Nivolumab is an antibody inhibitor of the programmed death-1 (PD-1) pathway. By blocking PD-1, this medication may allow the immune system to recognize and fight cancer
15901528|NCT03637530|Other|inverse ratio ventilation|during general anaesthesia in laparoscopic surgeries, this group of patients will receive inverse ratio ventilation with proper observation of hemodynamics
15901529|NCT03637517|Drug|DSM265-TPGS 34% SDD, 400 mg fasted|New formulation allowing smaller volumes of dissolution in a common vehicle (water), administered to subjects in a fasted state.
15901530|NCT03637517|Drug|DSM265-TPGS 34% SDD, 400 mg fed|New formulation allowing smaller volumes of dissolution in a common vehicle (water), administered to subjects in a fed state.
15901531|NCT03637517|Drug|DSM265 25% SDD, 400 mg fasted|Reference formulation used in early clinical trials.
15901532|NCT03637504|Behavioral|MedActionPlan®|web-based, mobile medication management application [MedActionPlan® (MAP)]
15901533|NCT03637491|Drug|Avelumab|IV treatment
15901534|NCT03637491|Drug|Binimetinib|Oral treatment
15901535|NCT03637491|Drug|Talazoparib|Oral treatment
15901536|NCT03637478|Behavioral|Enhanced Systems of Care Team|E-SOC team will be increasing connections between clinical care and community partners, such as schools, juvenile justice and child-serving state agencies, to reduce disparities in access to mental health/substance use evaluation and treatment. All aspects of the care continuum will be provided in a culturally and linguistically competent manner, with child and family-driven care planning. Overall goals are: earlier identification of mental health needs including child trauma; increased treatment access and adherence; care delivered in least restrictive settings; care experience reflecting active youth and family engagement; program sustainability and replicability.
15901537|NCT03637465|Behavioral|Hydrate Philly|"Hydrate Philly is a multi-component intervention that includes water safety testing, provision of 1-2 hydration stations per recreation center, distribution of reusable water bottles for youth, a campaign to promote the acceptability of tap water, and the reduction of access to competing unhealthy beverages through vending machine standards and discouraging black bags (characteristic small, black, plastic bags provided to customers with their corner store purchases, typically including a sugar sweetened beverage and/or unhealthy snack foods)."
15901538|NCT03637439|Other|Ultrasound-guided Percutaneous Neuromodulation|It's a new intervention of sport physiotherapy. It´s an invasive technique. It is necessary an ultrasound
15901539|NCT03637439|Other|Ultrasound-guided Percutaneous Needle|Same protocol without electricity
15901540|NCT03637426|Other|Laser|GLASER received the laser application using the infrared light spectrum with wavelength of 808 nm with its active AsGaAl medium in two points of the vestibular face of the hypersensitive teeth. It was applied at each point 60 J / cm², for 16 seconds. The laser was applied in 2 sessions with a time interval of 24 hours.
15901541|NCT03637426|Other|nano-hydroxyapatite|The GnHAP volunteers were submitted to the application of Desensibilize Nano P on the vestibular surfaces of hypersensitive teeth with the aid of a Microbrush applicator (Microbrush, 3M ESPE, São Paulo, Brazil) for 10 minutes. Then, a rubber cup (Unid Microdont, São Paulo, SP, Brazil) mounted on a low speed handpiece (Dabi Atlante, Ribeirão Preto, SO, Brazil) was used to scrub the desensitizing gel on teeth for 20 seconds in each tooth, according to the manufacturer's specifications
15901542|NCT03637426|Other|Laser + nano-hydroxyapatite|GLASERnHAP first received laser application and subsequently the application of nanohydroxyapatite according to the manufacturer's recommendations.
15901543|NCT03637426|Other|PLACEBO|In this group, a toothpaste without addition of fluoride or any other desensitizing agent (Natural, Contente®, Uberlândia, MG, Brazil) was applied to hypersensitive dentine. The GPLACEBO volunteers were submitted to the application of placebo dentifrice on the vestibular surfaces of hypersensitive teeth with the aid of a Microbrush applicator (Microbrush, 3M ESPE, São Paulo, Brazil) for 10 minutes. Then, a rubber cup (Unid Microdont, São Paulo, SP, Brazil) mounted on a low speed handpiece (Dabi Atlante, Ribeirão Preto, SO, Brazil) was used to scrub the desensitizing gel on teeth for 20 seconds on each tooth.
15901544|NCT03637413|Dietary Supplement|Hindmilk|Mother will be taught to separate her milk and infant will receive only hindmilk for feeds
15901545|NCT03637400|Drug|TMP-SMX|TMP-SMX will be administered over a period of 7 days.
15901546|NCT03637400|Drug|DOXY|DOXY will be administered over a period of 7 days.
15901547|NCT03637387|Drug|BIIB074|Administered as specified in the treatment arm
15901548|NCT03637387|Drug|Placebo|Administered as specified in the treatment arm.
15901549|NCT03637374|Device|Visceral Manifold and Thoracic Bifurcation|Endovascular stent graft system
15901550|NCT03637374|Device|Unitary Manifold|Endovascular stent graft system
15901551|NCT03637374|Device|TAAA Debranching Stent Graft System|Endovascular stent graft system
15901552|NCT03637361|Drug|REL-1017|The investigational product, REL-1017 is prepared as a solution with Ocean Spray® Diet Cranberry Juice on site to obtain a final volume of 100 mL for dosing. The study drug will be administered as a solution of 5 mg, 20 mg, 60 mg, 100 mg, 150 mg or 200 mg REL-1017, based on randomization prepared in Ocean Spray® Diet Cranberry Juice with a final volume of 100 mL
15901553|NCT03637361|Drug|Placebo|
15901554|NCT03637348|Device|TrueTear|Ues of TrueTear neurostimulator
15901555|NCT03637335|Combination Product|irradiation + carboplatin|30 Gy en 10 fractions de 3 Gy + 10 injections of carboplatin
15922624|NCT03477123|Device|Walking therapy with Exo-H2 exoskeleton|
15901557|NCT03637309|Behavioral|BeReady2Smile Video and App|BeReady2Smile is a coordinated oral health prevention intervention program that includes video content that features demonstrations/content on encouraging brushing, proper loading of toothbrush, brushing duration and frequency, fluoride myths, and limiting sugar sweetened beverages and milk in baby bottles while in bed. BeReady2Smile will also include a mobile application built within a web-based infrastructure, so parents can participate in multi-media educational activities, develop dental health behavior plans, tailor features and receive feedback from the system on a secure website.
15901558|NCT03637296|Other|Critical time intervention|Care management offered by individual with experience working with individuals with serious mental illness. The care managers engage individuals before they are discharged from the hospital and work with them in the community to support linkages with medical and behavioral health care providers. Care managers provide problem-solving, advice, and support to maximize patients' engagement in care.
15901559|NCT03637283|Procedure|anti-VEGF|vitreoretinal surgery combined with intraoperative anti-VEGF
15901560|NCT03637283|Procedure|fan-shaped photocoagulation|vitreoretinal surgery combined with intraoperative fan-shaped photocoagulation
15901561|NCT03637270|Dietary Supplement|Dietary supplementation|Before and after each exercise session, the research assistant will give subjects protein supplement or carbohydrate supplement according to the treatment assignment and ask them to drink it down right away.
15901562|NCT03637270|Other|Exercise training|Including aerobic cycling training and progressive resisted exercise
15901563|NCT03637257|Device|modified Guedel airway|Monitoring of breathing
15901564|NCT03637244|Behavioral|Decision Support Aid and PrEP for Black Canadians|Ottawa Decision Support Framework Adaptation.Investigators will use the inputs from the qualitative findings, CDC public health guidance and the tenofovir + emtricitabine product monograph to tailor the ODSF for use in the C5TM PrEP decision support web-app.
15901565|NCT03637231|Diagnostic Test|Ultra low-dose CTAC|All patients undergo two non-contrast enhanced CT scans with standard dose (i.e. 120 kVp), one with 80 kVp and one with 70 kVp.
15901566|NCT03637218|Other|Assessment at Low Altitude (470m above sea level)|Assessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure
15901567|NCT03637218|Other|Exposure to High Altitude (2500m above sea level)|Exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hours
15901568|NCT03637205|Procedure|ECLS insertion|After diagnostic angiography the culprit lesion should be identified and revascularization (preferably by PCI, alternatively CABG) should be planned. ECLS insertion should be performed preferably before revascularization
15901569|NCT03637205|Other|Revascularisation and optimal medical treatment|After diagnostic angiography the culprit lesion should be identified and revascularization (preferably by PCI, alternatively CABG) should be planned.
15901570|NCT03637192|Other|Low altitude: 470m above sea level|Assessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure
15901571|NCT03637192|Other|Säntis; 2500m above sea Level|Exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hours
15901572|NCT03637179|Other|Assessment at Low Altitude (470m above sea level)|Assessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure
15901573|NCT03637179|Other|Exposure to High Altitude (2500m above sea level)|Exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hours
15901574|NCT03637166|Other|Assessment at Low Altitude (470m above sea level)|Assessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure
15901575|NCT03637166|Other|Exposure to High Altitude (2500m above sea level)|"Exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hours"
15901576|NCT03637153|Other|Assessment at Low Altitude (470m above sea level)|Assessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure
15901577|NCT03637153|Other|Exposure to High Altitude (2500m above sea level)|Exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hours
15901578|NCT03637140|Device|Simulated Altitude (FiO2: 15.1%)|"Inhalation of deoxygenated air through a altitude simulator (Altitrainer), for approx. 1 hour. given by a facemask."
15901579|NCT03637140|Device|Shamed Hypoxia (FiO2: 20.9)|"Inhalation of unmodified air through an altitude simulator (Altitrainer) for approximately 1 hour given by a facemask"
15901580|NCT03637127|Device|Simulated Altitude (FiO2: 15.1%)|"Inhalation of deoxygenated air through a altitude simulator (Altitrainer), for approx. 1 hour. given by a facemask."
15901581|NCT03637127|Device|Shamed Hypoxia (FiO2: 20.9)|"Inhalation of unmodified air through an altitude Simulator (Altitrainer) for approximately 1 hour given by a facemask"
15901582|NCT03637114|Device|Simulated Altitude (FiO2: 15.1%)|"Inhalation of deoxygenated air through a altitude simulator (Altitrainer), for approx. 1 hour. given by a facemask."
15901583|NCT03637114|Device|Shamed Hypoxia (FiO2: 20.9)|"Inhalation of unmodified air through an altitude Simulator (Altitrainer) for approximately 1 hour given by a facemask"
15901584|NCT03637101|Diagnostic Test|Ischemia modified albumin (IMA)|Ischemia modified albumin is a biomarker for cardiac ischemia and acute stroke whether ischemic or hemorrhagic
15901585|NCT03637088|Device|Simulated Altitude (FiO2: 15.1%)|"Inhalation of deoxygenated air through a altitude simulator (Altitrainer), for approx. 1 hour. given by a facemask."
15901586|NCT03637088|Device|Shamed Hypoxia (FiO2: 20.9)|"Inhalation of unmodified air through an altitude simulator (Altitrainer) for approximately 1 hour given by a facemask"
15901587|NCT03637075|Other|intranasal insulin|intranasal administration of insulin (160 IU)
15901588|NCT03637075|Other|Placebo|placebo intranasal administration
15901589|NCT03637062|Drug|Progesterone|progeaterone:Utrogestan is one of the normal drugs in China to prevent spontaneous preterm birth, the Utrogestan used in this study is from Laboratories Besins International.
15901590|NCT03637062|Device|pessary|pessary: The cervical pessary is a vaginal device (silicone ring) that is used to treat pregnant women for preventing spontaneous preterm birth.
15901591|NCT03637049|Drug|PBI-4050 and midazolam|A single oral dose of midazolam (1 mL of 2mg/mL syrup) will be given to all subjects in Period 1 and on Day 5 of Period 2. 1200 mg of PBI-4050 (3 X 400 mg tablets) will be administered for 5 days (Day 1 to Day 5) of Period 2 and a single dose of midazolam (1 mL of 2mg/mL) on Day 5.
15903377|NCT03623230|Drug|Bupivacaine 0.25% Injectable Solution|Perineural Injection
15901592|NCT03637036|Other|Communication intervention|The intervention is a communication inviting staff to take up the influenza vaccination. Different versions of the communication are created, and the investigators will compare uptake rates between staff that received different letters.
15901595|NCT03637010|Other|Breakfast in the Classroom|For all breakfasts, the students will use the 'grab and go' approach from hallway kiosks. The students will take the breakfasts back to their respective classroom and consume them there.
15901596|NCT03636997|Procedure|Draining seton|Number 1 silk suture was passed through the fistula track and tied as loose seton
15901597|NCT03636997|Procedure|Rerouting of track|The seton and fistula track were rerouted to involve the internal anal sphicnter only and spare the external sphincter
15901598|NCT03636984|Drug|recombinant TNF-α receptor: IgG Fc fusion protein|50mg weekly
15901599|NCT03636971|Drug|hyaluronic acid with mannitol|single shot injection (Ostenil Plus®, TRB Chemedica SA, CH, 1800kD)
15901600|NCT03636971|Drug|hyaluronic acid with sorbitol|single shot injection (Synolis®, Gebro-Pharma AG, CH, 2000 kD)
15901601|NCT03636971|Drug|Placebos|single shot injection of saline, same volume
15901602|NCT03636958|Drug|Perampanel|Perampanel is an antiepileptic with a novel mechanism of action as it targets post-synaptic AMPA receptors. It has been shown to be effective as adjunctive therapy (dual therapy) for partial / focal epilepsy seizures and generalized in patients over 12 years of age.
15901603|NCT03636958|Drug|conventional antiepileptic treatment|choice of the molecule is left to the discretion of the clinician excluding the following benzodiazepines: clobazam, clonazepam, diazepam. Antiepileptic drugs allowed are therefore: lamotrigine, levetiracetam, lacosamide, sodium valproate, carbamazepine, oxcarbabazepine, slicarbazepine, pregabalin, gabapentin, topiramate, phenytoin, phenobarbital, zonisamide, vigabatrin.
15901604|NCT03636945|Other|PET at 18F-FDOPA|18F-fluorodihydroxyphenylalanine (18F-FDOPA) PET imaging
15901605|NCT03636932|Drug|N-acetylcysteine (NAC)|Intravenous injection of 2 gram of N-acetylcysteine (NAC) during 4 weeks, 3 times per week during the first three hours of dialysis.
15901606|NCT03636932|Drug|Placebo|Intravenous injection of 2 gram of Placebo during 4 weeks, 3 times per week during the first three hours of dialysis.
15901607|NCT03636932|Biological|Blood sample|Circulating tissue factor assay
15901608|NCT03636932|Biological|Blood sample|The test of pro-coagulant activity of the tissue factor
15901609|NCT03636919|Other|e-BOOK|Patients will filled an e (carnet) included the questionnaire includes the Control of Allergic Rhinitis and Asthma Test (CARAT)
15901610|NCT03636906|Biological|Respiratory syncytial virus (RSV) vaccine GSK3389245A|2 doses of study vaccine administered intramuscularly in the left anterolateral thigh side, at Day 1 and Day 31
15901611|NCT03636906|Biological|Bexsero|3 doses of active comparator administered intramuscularly in the left anterolateral thigh side, at Day 61, Day 121 and at the end of RSV season, or at Day 1, Day 61 and end of RSV season.
15901612|NCT03636906|Biological|Nimenrix|3 doses of active comparator administered intramuscularly in the left anterolateral thigh side, at Day 61, Day 121 and at the end of RSV season, or at Day 1, Day 61 and end of RSV season.
15901613|NCT03636906|Biological|Menveo|2 doses of active comparator administered intramuscularly in the left anterolateral thigh side, at Day 61 and at the end of RSV season, or at Day 31 and end of RSV season.
15901614|NCT03636906|Biological|Synflorix|3 doses of active comparator administered intramuscularly in the left anterolateral thigh side, at Day 61, Day 121 and at the end of RSV season, or at Day 1, Day 61 and end of RSV season.
15901615|NCT03636906|Drug|Placebo|2 doses of placebo administered intramuscularly in the left anterolateral thigh side at Day 1 and Day 61, or at Day 31 and Day 121
15901616|NCT03636893|Drug|FLOT Chemotherapy|5-FU+Leucovorin+Docetaxel+Oxaliplatin
15901617|NCT03636893|Drug|SOX Chemotherapy|Oxaliplatin+Tegafur gimeracil oteracil potassium capsule (TGO)
15901618|NCT03636880|Behavioral|Brief treatment for Insomnia|This behavioral intervention provides participants with an individualized plan to modify sleep patterns contributing to insomnia, as well as education about sleep hygiene and habits that help and hurt sleep.
15901619|NCT03636880|Behavioral|Sleep Monitoring|This intervention involves using sleep diaries to track daily aspects of sleep, including bed time, wake time, hours of sleep, nighttime awakenings, daytime naps, and sleep quality.
15901620|NCT03636867|Other|data and specimen collection|to identify laboratory, cellular and molecular determinants of clinical success after treatment, several clinical information and specimens will be collected by Authors from each patient
15901621|NCT03636854|Other|Concentric exercises|Resistance concentric straight leg raise and knee extension will be done.
15901622|NCT03636854|Other|Eccentric exercises|Resistance eccentric straight leg raise and knee extension will be done.
15901623|NCT03636841|Device|medical device with CE marking (Ultravision ©)|Ultravision © is a medical device that is used during laparoscopy to reduce the discomfort caused by surgical smoke produced by the electrical section of tissue. It works by using the principle of electrostatic precipitation, that is to say it causes the precipitation of suspended smoke droplets on the organs and walls of the abdomen.
15901624|NCT03636828|Diagnostic Test|ultrasonographic measurement of gastric antral cross-sectional area|Each participant fasted for 10 hours and subjected to a baseline gastric ultrasound and serial sonographic gastric evaluations was performed every hour after 2 hours of the ingestion of a 420 g, 536 Kcal rice-based meal (bibimbap) until the stomach was completely empty.
15901625|NCT03636815|Other|physical therapy|Cardiopulmonary rehabilitation for patients who receive left ventricle assist device
15901626|NCT03636802|Other|Questionnaire BPI|Brief Pain Inventory (BPI) This is a scale of self-assessment, the Concise Pain Questionnaire in French. For all adult patients For any type of pain This is to ask the patient to answer questions in order to learn about us characteristics of his pain (its intensity and its repercussions on the plane biopsychosocial).
15901627|NCT03636789|Other|Neurological consultation|study of horizontal, vertical, reflex and voluntary saccades, and of horizontal and vertical ocular pursuit by a BrainTracker eye-oculography system
15901628|NCT03636776|Other|Quality of life in metastatic BC|"1 month after metastatic stage diagnosis, patients complete their 1st therapeutic sequence evaluation visit (T1) within the recommended standard time frames. If the disease remains stable or if a response to treatment is observed then patients continue their follow-up in the same therapeutic sequence (T1).
~If progression occurs, treatment is modified and patients move on to the next therapeutic sequence (T2).
~And so on as many times as necessary. Before each evaluation visit with investigator, patients complete the questionnaires QLQ-C30, BR23, STAI, BDI II"
15901629|NCT03636763|Drug|data report|"the information gliptin exposure will be reported"
15901630|NCT03636750|Drug|HB002.1T|HB002.1T is a Vascular Endothelial Growth Factor Receptor Decoy
15901631|NCT03636737|Other|pathology associated|list of pathology associated to Pyoderma gangrenosum
15901632|NCT03636724|Behavioral|E-intervention|The 10-week e-health intervention will target HAPA-based social-cognitive variables of PA and FVI. Particularly, Week 1: risk perception and outcome expectancies; Week 2: goal setting; Week 3: development of action plans; Week 4: revision and adjustment of previous action plans; Week 5: development of coping plans; Week 6: revision and adjustment of previous coping plans; Week 7: development of perceived social support; Week 8: revision and adjustment of previous social support. Week 9-10: self-monitoring. Self-efficacy will be a fixed intervention variable involved from week 2 to week 10. Additionally, some behaviour change techniques will be employed in the intervention in order to facilitate the implementation and maintenance of behaviour.
15901633|NCT03636711|Other|antibiotic protocol, according to a syndromic approach|Description of patients who benefited or not the antibiotic protocol, according to a syndromic approach and analysis of the causes of non-adherence to the protocols
15901634|NCT03636698|Other|chorioamnionitis|It is a observation research. We didn't intervene anything. The chorioamnionitis groups included the infants whose mothers were diagnosed chorioamnionitis by placental histopathology.
15901635|NCT03636685|Drug|Anlotinib combined with pemetrexed and carboplatin, phase I|"Non-squamous cell lung cancer, Anlotinib Plus PC
~This study will include a sequential evaluation of 3 subjects per dose group. low-dose groups: Anlotinib 8mg per day plus pemetrexed and carboplatin. middle-dose groups: Anlotinib 10mg per day plus pemetrexed and carboplatin. high-dose groups: Anlotinib 12mg per day plus pemetrexed and carboplatin to determine the appropriate dose of anlotinib in combination with paclitaxel and carboplatin"
15901636|NCT03636685|Drug|Anlotinib combined with paclitaxel and carboplatin, phase I|"Squamous cell lung cancer, Anlotinib plus TC
~This study will include a sequential evaluation of 3 subjects per dose group. low-dose groups: Anlotinib 8mg per day plus paclitaxel and carboplatin. middle-dose groups: Anlotinib 10mg per day plus paclitaxel and carboplatin. high-dose groups: Anlotinib 12mg per day plus paclitaxel and carboplatin to determine the appropriate dose of anlotinib in combination with paclitaxel and carboplatin"
15901637|NCT03636685|Drug|Anlotinib combined with pemetrexed and carboplatin, phase II|Anlotinib: established dose QD PO d1-14, pemetrexed,carboplatin, 21 days per cycle after 4-6 cycles, Anlotinib p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent
15901638|NCT03636685|Drug|Anlotinib combined with paclitaxel and carboplatin, phase II|"Anlotinib :established dose QD PO d1-14, paclitaxel,carboplatin, 21 days per cycle
~after 4-6 cycles, Anlotinib p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent"
15901639|NCT03636672|Procedure|perturbation training|perturbation training during stationary bicycle riding
15901640|NCT03636659|Drug|Amphotericin B Liposome|Manufactured for: Auromedics Pharma LLC, USA
15901641|NCT03636659|Drug|AmBisome (Amphotericin B) Liposome|Marketed by: Astellas Pharma US, Inc. USA
15901642|NCT03636646|Device|X.ray|Surgical treatement of posterior acetabular wall fractures
15901643|NCT03636633|Other|Standard respiratory physiotherapy|Standard respiratory physiotherapy content; diaphragmatic breathing, pursed lip breathing, segmental breathing, incentive spirometer exercises (Triflo) and coughing techniques.
15901644|NCT03636633|Other|Standard respiratory physiotherapy and inspiratory muscle training|Standard respiratory physiotherapy content; diaphragmatic breathing, pursed lip breathing, segmental breathing, incentive spirometer exercises (Triflo) and coughing techniques. Addition to that, threshold IMT device will be used for the training. Training intensity will set at 40% of the maximum inspiratory pressure.
15901645|NCT03636620|Device|Transcatheter arterial chemoembolization|Transcatheter arterial chemoembolization
15901646|NCT03636620|Device|radiofrequency ablation/microwave ablation|radiofrequency ablation/microwave ablation
15901647|NCT03636607|Diagnostic Test|PET/CT dynamic scan|The purpose of this study is to carry out 18F-FDG PET/CT dynamic scans and biopsy of primary or primary and metastatic lesions in newly diagnosed patients with primary liver cancer, and to compare imaging findings, genomics, and pathology at the same time. The intrinsic relationship between tissue characteristics and the diagnostic value of 18F-FDG PET/CT dynamic imaging in primary liver cancer metastases are discussed.
15901648|NCT03636594|Other|Dance|The dance program consisted of one-hour dance classes delivered twice a week for 8 weeks. The classes featured different dance types (such as partnered and non-partnered) and genres (such as salsa, ballroom and jazz) with increasing complexity.
15901649|NCT03636581|Behavioral|Lifestyle counseling|This group will receive online education modules to educate them on exercise prescription, nutrition and behavioral changes.
15901650|NCT03636568|Other|Fluid Restricted Group|"Patients will be started on a weight-based intravenous fluid replacement with D5 ½ NS on POD 0 (75 cc/hr for patients < 70kg, 100 cc/hr for patients 70-100kg, and 125 cc/hr for patients >100kg). Patients will be allowed to drink water freely after surgery on POD #0. Fluids will be stopped at 8am on POD 1 and patients will be started on a moderate fluid restriction on POD #3 based on their weight (1000 cc/24 hours for patients who weigh <=100 kg and 1200 cc/24 hours for patients who weigh > 100kg). Prior to initiation of a fluid restriction all of the following criteria have to be met:
~Serum Na level must be < 145 mEq/l
~Patient should be taking fluids by mouth
~Patient should not have evidence of DI (as determined by endocrine team following patient) If a patient in Fluid Restricted group develops DI, the fluid restriction will be stopped/not initiated."
15901651|NCT03636555|Drug|Oxytocin|Oxytocin will be given in an intranasal spray (Syntocinon Spray) twice daily (10 insufflations, 1.0 mL, 40 IU/dose) for 12 weeks
15901652|NCT03636555|Drug|Placebo|Placebo solution (contained all the ingredients in Syntocinon Spray except for oxytocin) will be given as an intranasal spray twice daily (10 insufflations, 1.0 mL/dose) for 12 weeks
15901655|NCT03636529|Dietary Supplement|Tart cherry juice|Participants randomized to consume for 4-weeks either placebo beverage or single-strength tart cherry juice at beginning of the study followed by a 4 week washout then switch over to the alternate beverage for 4 weeks to account for timing and order effects.
15901656|NCT03636529|Other|Placebo|Participants randomized to consume either placebo beverage or tart cherry juice at beginning of the study followed by a 4 week washout then switch over to the alternate beverage to account for timing and order effects.
15901657|NCT03636516|Device|SWL|extracorporeal shockwave lithotripsy apply
15901658|NCT03636503|Drug|Rituximab|Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatmen
15901659|NCT03636503|Drug|Utomilumab|Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
15901660|NCT03636503|Drug|Avelumab|Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug
15901661|NCT03636503|Drug|PF04518600|In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40
15901662|NCT03636490|Behavioral|Psychological Stress Intervention|Participant will be shown a series of words for five minutes and a research coordinator will ask him/her to name the color of each (Stroop Color-Word Conflict Task). Then, for another five minutes, the participant will be asked to count backwards out loud by sevens starting from 1,000 (Mental Arithmetic Task). The research assistant will ask the participant to work as quickly and accurately as possible for both tasks.
15901663|NCT03636477|Biological|Ad-RTS-hIL-12|"2.0 x 10^11 viral particles (vp) per injection
~intratumoral injection of Ad-RTS-hIL-12"
15901664|NCT03636477|Drug|veledimex|"2 doses (10mg/day, 20mg/day)
~15 oral daily doses of veledimex"
15901665|NCT03636477|Drug|Nivolumab|"2 doses (1mg/kg, 3mg/kg)
~Every 2 weeks"
15901666|NCT03636464|Other|Blood collection|Pharmacokinetics
15901667|NCT03636438|Other|No Intervention|No Intervention
15901668|NCT03636425|Other|Questionnaire administration to gather information|In the questionnaire there are questions about the training (number of kilometers traveled by runners on average, total height difference, number of training sessions per week, training ground) questions on other activities carried out (gym, bicycle, etc.) number of competitions that runners participated in the month, used footwear, musculoskeletal disorders in the last 12 months, which health professional the runner has addressed, which physiotherapy therapies did.
15901669|NCT03636412|Other|Ambulation|An ambulator will walk with a patient three times a day, based on physical therapy recommendations.
15901670|NCT03636399|Behavioral|Standard GIST|13 group modules will be administered to outpatients in 12 x 2,5-3 hours sessions. Manualized intervention; In every group session a new topic is presented, discussed and practiced in group exercises. Homework assignments between sessions.
15901671|NCT03636399|Behavioral|Intensive GIST|13 group modules will be administered to inpatients during 4 weeks in hospital. Participants is admitted to a hospital unit for cognitive rehabilitation treating patients in acute and/or cronic phase. The participants are given extended leave every weekend to work on homework Assignments between each treatment week.
15901672|NCT03636386|Device|Percutaneous microelectrolysis|284/5000 Application of Direct Current through an acupuncture needle with intensities in microamps (μA) in the PGm of the upper trapezius muscle. The acupuncture needle will correspond to the negative electrode or cathode. The intensity of work will be 610μA at the myofascial trigger point.
15901673|NCT03636386|Device|Ultrasound therapy|Application of conventional ultrasound (US) on PGm with a frequency of treatment 1MHz, intensity of 1.5W / cm2, ERA 5cm2, Duty Cycle 100%, treatment time 6 minutes.
15901674|NCT03636373|Drug|Etanercept|Subjects will receive 50 mg of study drug on visit 1. A second dose of study drug will be administered if the pain intensity is ≥ 5 on a pain scale of 0-10 at Visit 2
15901675|NCT03636373|Drug|Triamcinolone Acetonide|Subjects will be administered triamcinolone acetonide 40 mg intramuscularly on visit 1. A second dose of drug will be administered if the pain intensity is ≥ 5 on a pain scale of 0-10 at Visit 2
15901676|NCT03636360|Device|Light|15 hours of light exposure
15901677|NCT03636347|Drug|Placebo Oral Tablet|twice daily administration
15901678|NCT03636347|Drug|Alvelestat oral tablet - dose 1|twice daily administration
15901679|NCT03636347|Drug|Alvelestat oral tablet - dose 2|twice daily administration
15901680|NCT03636334|Behavioral|Computer-based decision support system|At intervention sites, physicians will receive training and support on use of the DSS, which will be installed on their local IT system. Individuals eligible for DSS at Intervention sites will be randomized or assigned to different drug sequence protocols for BP-lowering therapy using their current antihypertensive medications, co-morbidities, and intolerance to medications and according to the assignment plan in the Algorithm. If the protocol is not suitable for the patient because of new co-morbidities, medication intolerance or contraindication, the DSS will recommend switching to a new protocol.
15901681|NCT03636321|Procedure|living donor liver transplantation with internal biliary stent|living donor liver transplantation without internal biliary stent
15901682|NCT03636308|Drug|nanoparticle albumin-bound paclitaxel|Nanoparticle albumin-bound paclitaxel is given at 125 mg/m2 intravenously on day 1 of each 14 day cycle or day 1 and 8 of 21 day cycle.
15901683|NCT03636308|Drug|S1|S-1 is orally administered (BSA<1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2, 50mg bid, BSA>1.5m2, 60mg bid) on day 1-7 of each 14 day cycle.
15901684|NCT03636308|Drug|Gemcitabine|Gemcitabine is given at 1000mg/m2 intravenously on d1 and 8 of each 21 day cycle.
15901685|NCT03636295|Drug|Warfarin|Participants in both arms will be on warfarin therapy post-mechanical valve replacement as is standard, but will have different INR target ranges.
15901794|NCT03635697|Behavioral|Mindfulness Auditory Intervention|This intervention is a short audio clip that focuses on the practices and principles of mindfulness. The goal of mindfulness is to bring awareness to a person's physical body as well as their thoughts and feelings.
15901795|NCT03635684|Drug|Acetaminophen|"Subcutaneous infusion of Acetaminophen over 20 to 30 minutes, with evaluation of:
~local side effects;
~pain and/or fever;
~at time of infusion, after 30 minutes, 60 minutes and 180 minutes."
15901686|NCT03636282|Behavioral|Hockey FIT Program (Immediate Delivery)|"Hockey FIT is comprised of a 3-Month Active Phase and a 9-Month Minimally-Supported Phase.
~Active Phase: 12 weekly, 90-minute group-based sessions consisting of classroom-based education and exercise. Outside of sessions, participants follow their individualized lifestyle prescriptions for healthy eating, physical activity (steps), and exercise. Participants are encouraged to regularly use health technology support tools customized to Hockey FIT. Minimally-supported phase: Participants are encouraged to continue with their healthy lifestyle behaviour changes and to regularly use the health technology support tools."
15901687|NCT03636269|Drug|CR845 0.5 mcg/kg|IV CR845 0.5 mcg/kg administered three times/week
15901688|NCT03636269|Drug|Placebo|IV placebo administered three times/week
15901689|NCT03636256|Drug|NanoDoce (direct injection)|Subjects will receive NanoDoce injected into the index tumor resection site on the bladder wall, immediately following transurethral resection of the bladder tumor (TURBT)
15901690|NCT03636256|Drug|NanoDoce (intravesical instillation) - Visit 2 Instillation|All subjects will receive an initial intravesical instillation within 2 hours of direct injection.
15901691|NCT03636256|Other|Institutional Standard of Care|Group 2 (MIBC) will receive institutional standard of care treatments after the Visit 2 intravesical instillation.
15901692|NCT03636256|Drug|NanoDoce (intravesical instillation) - Induction and Maintenance Instillations|Group 1 (NMIBC) will receive intravesical instillations in an Induction Period and a Maintenance Period.
15901693|NCT03636243|Biological|Vascularly biological assessment|22.5 ml of blood will be collected at day -15, month 3 and month 12.
15901694|NCT03636243|Biological|Analysis of vasomotor endothelial function|Evaluation of the peripheral endothelial function by digital tonometry using the 'EndoPATTM2000' system [Itamar Medical Ltd., Caeserea, Israel] before and after induction of post occlusive reactive hyperemia at day -15, month 3 and month 12.
15901695|NCT03636243|Biological|Analysis of arterial compliance|Evaluation of the aortic pulse wave velocity in the aortofemoral segment or in the periphery (on the arm-ankle segment) by calculation of central aortic pressure (CAP) using the tonometric system 'Complior ™' [Alam Medical, France] at day -15, month 3 and month 12
15901696|NCT03636243|Biological|Exploration of microcirculation|The microcirculation exploration via analysis of the curves recorded by Laser Doppler at day -15, month 3 and month 12
15901697|NCT03636243|Biological|Venous Doppler Ultrasound|aneurysm screening at day -15, month 3 and month 12
15901698|NCT03636243|Biological|Arterial pressure measurement|measurement of the systolic pressure at the toe using the SysToe™ device, and measurement of systolic and diastolic blood pressure using the Dinamap™ device at day -15, month 3 and month 12
15901699|NCT03636243|Biological|Intima-Media Thickness measurement|Intima-Media Thickness measurement using an ultrasound machine at day -15, month 3 and month 12
15901700|NCT03636243|Biological|Exploration of neuropathy|non-invasive measurement of sudomotor function by SUDOSCAN at day -15, month 3 and month 12
15901701|NCT03636243|Behavioral|level of physical activity|pedometer collecting the number of steps during the four days before visits at day -15, month 3 and month 12
15901702|NCT03636230|Device|Remote Monitoring|Remote Monitoring only
15901703|NCT03636230|Other|Standard of care|In-Clinic visits only
15901704|NCT03636217|Other|LGI-Milk Breakfast|This test meal with low glycemic index and milk were served as a breakfast after 12-hours fasting and participants were asked to consume the meal in full, within 15 min.
15901705|NCT03636217|Other|LGI-Kefir Breakfast|In crossover design, this test meal with low glycemic index and kefir was served as a breakfast to compare the LGI-Milk Breakfast.
15901706|NCT03636217|Other|HGI-Kefir Breakfast|In crossover design, this test meal with high glycemic index and kefir was served as a breakfast to compare the LGI-Milk Breakfast and the LGI-Kefir Breakfast.
15901707|NCT03636204|Biological|AL001|Active dose of AL001
15901708|NCT03636204|Other|Placebo|Saline solution administered as a single infusion as palcebo.
15901709|NCT03636191|Dietary Supplement|Probiotic strain|Lactobacillus
15901710|NCT03636191|Dietary Supplement|Placebo|Placebo
15901711|NCT03636178|Procedure|Classic alar base suture technique|An index finger will be used to apply extraoral pressure on the alar base region, and a dentate forceps will grasp this tissue through the intraoral incision. A suture bite will be taken at this point through the tissue previously held by the forceps. The same procedure will be applied on the opposite side. After passing the suture on both sides, it will be tightened with attention to the alar base response. If the alar base suture will be judged to be adequate, the vestibular incision will then be closed in a routine fashion, with or without performing a V-Y lip closure
15901712|NCT03636178|Procedure|Modified alar base suture technique|The alar base will be marked with 3 landmarks: left alar base (point LAB), columella (point C), and right alar base (point RAB). A needle will be inserted through the skin at the nasofacial skin fold and exited through the fibroareolar tissue. A nonabsorbable suture without a needle will be inserted through the needle from the oral cavity to the outside. The needle will be retracted through point RAB without leaving the skin point, then returned to the oral cavity in a medial position. Finally the needle will be retracted from point RAB, leaving the suture through the soft tissue. The same procedure will be repeated on the other side. The 2 free ends of the sutures will be then tied together after passing through a hole made in the nasal spine.
15901715|NCT03636152|Procedure|MRI carotid|To assess the carotid atherosclerotic plaques
15901716|NCT03636152|Procedure|APWV|Doppler measurement of the APWV
15901717|NCT03636152|Drug|Hydroxychloroquine|Active Drug
15901718|NCT03636152|Drug|Matching Placebo|Matching Placebo for the control group.
15901719|NCT03636139|Device|transcranial DC stimulation : anodal|anodal stimulation of the right dlPFC (i.e. F4) for 20 minutes
15901720|NCT03636139|Device|transcranial DC stimulation : sham|sham stimulation of the right dlPFC (i.e. F4) for 20 minutes
15901796|NCT03635671|Diagnostic Test|Optical Coherence Tomography Angiography|Retinal scans will be acquired at each follow up visit
15901797|NCT03635658|Procedure|titanium mesh|the non resorbable titanium mesh is used to fix the 1:1 mixture of autograft and xenograft particulate bone on the severely atrophies maxillary ridge.
15901721|NCT03636126|Device|VR + TACS|TACS- A regulated class of transcranial alternating current stimulation (tACS), called Cranial Electrotherapy Stimulation (CES) by Fisher Wallace Laboratories (FWL) is FDA-Cleared to treat depression, anxiety, and insomnia (Proof of FDA clearance and 510k provided in the appendix). FWL tACS delivers weak non-invasive electrical stimulation (1-4 milliamps at 15, 500, and 15,000 Hz) to the frontal/temporal brain regions by electrodes placed above the temples. Land's End Virtual Reality Game Meta-analyses show Virtual Reality (VR) is an effective non-pharmacological method that reduces obstacles to human performance such as pain, insomnia, anxiety, sleep deprivation, and a variety of other stress responses.
15901722|NCT03636113|Device|Clarity RMS Electronic Sensor|The urinary foley catheter with electronic sensor will be placed within the Operating Room prior to surgery. Upon arrival to the ICU, the device will be connected to an electronic console by study coordinator. The study coordinator will weigh the urine drainage bag and record the weight every hour for 4-6 hours. The device will record urine flow on a 15 minute interval up to 6 hours
15901724|NCT03636087|Procedure|Access cavity preparation|High speed handpieces will be used with access burs to open the pulp chamber and get access to the root canal system (As a part of conventional root canal treatment established protocol)
15901725|NCT03636087|Procedure|Working Length Determination|The length of the root canal will be measured using periodical radiographs and Electronic Apex Locators (As a part of conventional root canal treatment established protocol)
15901726|NCT03636087|Procedure|Root canal instrumentation and chemo-mechanical preparation|Rotary files used to properly instrument and prepare canals length and size (As a part of conventional root canal treatment established protocol)
15901727|NCT03636087|Procedure|Root canal obturation|Gutta Percha filling materials will be used to fill the root canal space with root canal sealer (As a part of conventional root canal treatment established protocol)
15901728|NCT03636087|Procedure|Coronal restoration build up|A Build up material to seal the accessed tooth properly (As a part of conventional root canal treatment established protocol)
15901729|NCT03636087|Other|Changing gloves before obturation|The treating dentist will change gloves before obturation
15901730|NCT03636087|Other|Disinfecting rubber dam|2.25% Sodium Hypochlorite solution will be used to disinfect the rubber dam surface
15901731|NCT03636087|Other|The use of new instruments at time of obturation|A new instrument's kit will be use at the time of obturation
15901732|NCT03636087|Radiation|Cone Beam Computed Tomography scanning (CBCT)|CBCT will be taken before treatment and one year after completion
15901733|NCT03636087|Radiation|Radiographic imaging using periapical radiographs|Periapical radiographs will be taken before, during and one year after the treatment completion (As a part of conventional root canal treatment established protocol)
15901734|NCT03636074|Procedure|Hypothermia during Extracorporeal Circulation|Normothermia during Extracorporeal Circulation
15901737|NCT03636048|Drug|Bupivacaine Hcl 0.5% Inj|The patients undergo surgery under spinal anesthesia and a catheter would be inserted into epidural space during the procedure. 0.5% bupivacaine is injected into intrathecal space for spinal anesthesia. For pain control, 0.2% ropivacaine is continuously infused into epidural space postoperatively.
15901738|NCT03636048|Drug|Propofol 10 milligram/ML|The patients undergo surgery under general anesthesia and a catheter would be inserted to abdominal incision site at the end of the operation. Propofol is used for induction of general anesthesia, and sevoflurane is used for maintenance of anesthesia. At the end of the operation, the surgeon inserts wound catheter in the surgical site and connects wound patient-controlled analgesia device filled with 0.5% ropivacaine.
15901739|NCT03636035|Dietary Supplement|Tregocel®|Coated tablet (oral)
15901740|NCT03636022|Other|VR System|Use of virtual reality to deliver exposure therapy
15901741|NCT03636022|Other|Control|Use of conventional delivery of exposure therapy
15901742|NCT03636009|Other|concurrent traction and neuromobilization technique|participant will be on a mechanical traction machine with an on:off cycle. During the on cycle, the primary researcher will be performing a neuromobilization technique on the symptomatic arm. Patients will also receive exercise and manual therapy
15901743|NCT03636009|Other|sequential traction and neuromobilization technique|Participants will receive neuromobilzation techniques followed by supine cervical traction
15901744|NCT03636009|Other|active exercise program|Participants will have 4-5 exercises to perform at each session
15901745|NCT03636009|Other|manual therapy to cervical and thoracic spine|Lateral glides to cervical spine and thoracic manipulations
15901746|NCT03635996|Drug|Etripamil NS 70 mg|All patients will receive a total of 200 micro-liters of etripamil NS 70 mg via the Aptar Pharma Nasal Spray Bidose System each time they self-administer study drug.
15901747|NCT03635996|Device|Aptar Pharma Nasal Spray Bidose System|Patients will self-administer the study drug using the Aptar Pharma Nasal Spray Bidose System. The devices will be prefilled and packaged into child-resistant boxes.Instructions for its use will be provided in the study drug box.
15901748|NCT03635983|Biological|NKTR-214|Specified dose on specified days
15901749|NCT03635983|Biological|Nivolumab|Specified dose on specified days
15901750|NCT03635970|Procedure|celular therapy|application of cell therapy with a concentrate of hematopoietic progenitor cells or celular therapy
15901751|NCT03635957|Biological|Pegloticase|pegloticase administered intravenously (IV)
15901752|NCT03635957|Drug|Methotrexate (MTX)|oral MTX
15901753|NCT03635957|Drug|Standard Gout Flare Prophylaxis|It is required that before a subject begins the Pegloticase + IMM Period, he or she has been taking at least one protocol standard gout flare prophylaxis regimen (i.e. colchicine and/or nonsteroidal anti-inflammatory drugs and/or low-dose prednisone ≤10 mg/day) for ≥1 week before the first dose of pegloticase and continues flare prophylaxis per American College of Rheumatology guidelines [Khanna D et al.2012] for the greater of 1) 6 months, 2) 3 months after achieving target serum urate (sUA < 6 mg/dL) for patients with no tophi detected on physical exam, or 3) 6 months after achieving target serum urate (sUA < 5 mg/dL) for patients with one or more tophi detected on initial physical exam that have since resolved.
15901867|NCT03635125|Drug|Nebivolol I|Low dose treatment phase: Nebivolol 10 mg or Metoprolol 50 mg High dose treatment phase: Nebivolol 20 mg or Metoprolol 100mg
15901754|NCT03635957|Drug|Infusion Reaction (IR) Prophylaxis|For IR prophylaxis, fexofenadine (60 mg or 180 mg orally based on the Principal Investigator's discretion) will be taken the day before each infusion; fexofenadine (60 mg or 180 mg orally based on the Principal Investigator's discretion) and acetaminophen (1000 mg orally) will be taken the morning of each infusion; and methylprednisolone (125 mg IV) given over the infusion duration 10-30 minutes (recommended) or hydrocortisone (200 mg IV) will be administered immediately prior to each infusion.
15901755|NCT03635957|Dietary Supplement|Folic Acid|Subjects will also take folic acid 1 mg orally every day beginning at Week -4 (the start of MTX) and continuing until prior to the Week 52 Visit.
15901756|NCT03635931|Procedure|Concentrated Growth Factor|surgical treatment with CGF for papilla regeneration
15901757|NCT03635918|Device|NightOwl HSAT|Patient wears the NightOwl sensor device
15901758|NCT03635905|Drug|Gabapentin|Gabapentin (Neurontin®) is FDA-approved for the treatment of post-herpetic neuralgia and seizure disorder. Off-label uses include chronic refractory cough, neuropathy, hot flashes, restless leg syndrome, social anxiety disorder, and post-operative pain
15901759|NCT03635905|Drug|Placebo|Methylcellulose placebo capsule
15901760|NCT03635892|Drug|cabozantinib|cabozantinib 40mg, self administered orally once daily on a continuous schedule (days 1-28) Patients will continue to take cabozantinib until disease progression (unless continuing treatment beyond progression), major toxicity, or withdrawal from the study for any reason.
15901761|NCT03635892|Drug|nivolumab|Patients will receive an intravenous infusion of nivolumab, per institutional standards, at 240 mg on Cycle 1, Day 1 and will return to the center approximately every two weeks (14 ± 3 days) for subsequent infusions until disease progression (unless continuing treatment beyond progression), major toxicity, or withdrawal from the study for any reason.
15901762|NCT03635879|Other|MCTprocal medical food|32 g MCTprocal (20 g MCT) mixed in 180 mL of water at Hour 0 Day 1
15901763|NCT03635879|Other|Milk/tricaprilin oil blend|154 mL of lactose-free skim milk/21 mL of tricaprilin oil blended and then mixed in 180 mL of water at Hour 0 Day 1
15901764|NCT03635879|Other|AC-1207|AC-1207 (20 g MCT) mixed in 180 mL of water at Hour 0 Day 1
15901765|NCT03635879|Other|AC-1205|AC-1205 (20 g MCT) mixed in 180 mL of water at Hour 0 Day 1
15901766|NCT03635879|Other|AC-1206|AC-1206 (20 g MCT) mixed in 180 mL of water at Hour 0 Day 1
15901767|NCT03635879|Drug|AC-1202|AC-1202 (20 g MCT) mixed in 240 mL of water at Hour 0 Day 1
15901768|NCT03635866|Diagnostic Test|Fluciclovine PET/MRI|It is unknown how many negative MRFTBs of PI-RADS 4 lesions are false negative biopsies or false positive tests.
15901769|NCT03635853|Drug|drug containing extract from cock's comb|a container containing 25 mg of ointment having extract from cock's comb as active ingredient two times daily for 3 months
15901770|NCT03635840|Device|Intra Aortic Balloon Pump|"Intra Aortic Balloon Pump (IABP) is a circulatory mechanical support device, placed in descending aorta, distally from left subclavian artery and proximally from renal artery. IABP works with counterpulsation concept, synchronized with heart cycle. It is indicated as supportive therapy for patients undergoing revascularization, cardiogenic shock and mechanical complication.
~Balloon dilatation during dyastolic phase increasing dyastolic pressure in aorta, improving coronary vascularization and myocardial oxygen supply. In systolic phase, the balloon deflates, reducing the left ventricle afterload hence decreasing myocardial oxygen demand."
15901771|NCT03635827|Combination Product|NBTX-001 Xenon Inhaler|The NBTX-001 medical gas consists of 30% xenon, 30% oxygen, and 40% nitrogen. The dose of medical gas is 10 L by volume.
15901772|NCT03635827|Combination Product|Placebo|The placebo medical gas consists of 30% oxygen and 70% nitrogen.The dose of placebo medical gas is 10 L by volume.
15901773|NCT03635814|Drug|YD312 50mg|YD312 50mg * 1 + placebo 6 tablets
15901774|NCT03635814|Drug|YD312 150mg|YD312 50mg * 3 + placebo 6 tablets
15901775|NCT03635814|Drug|YD312 350mg|YD312 50mg * 7 tablets
15901776|NCT03635814|Drug|Placebo|YD312 0mg * 7 tabets
15901777|NCT03635801|Device|MyoVista 12 lead Electrocardiogram (ECG)|MyoVista 12 Lead Electrocardiogram (ECG)
15901785|NCT03635775|Device|Active tDCS|Low-level (1.5 milliampere) current delivered to the scalp using saline-soaked sponges.
15901786|NCT03635775|Device|Sham tDCS|Sham-setting--no electrical current delivered.
15901787|NCT03635762|Behavioral|Be In Charge|comparison of pre and post-program weight and calorie intake
15901788|NCT03635749|Drug|Intensive antiplatelet|"Day 1：clopidogrel 300mg/day+ aspirin100-300mg/ day
~Day2 - 21: clopidogrel 75mg/day+ aspirin 100mg/day
~Day22 - 90: clopidogrel 75mg/day+aspirin placebo"
15901789|NCT03635749|Drug|Standard antiplatelet|"Day 1: Aspirin 100-300mg/day + clopidogrel placebo
~Day 2 - 90: Aspirin 100mg/day+ clopidogrel placebo"
15901790|NCT03635749|Drug|Immediate high-intensity statin|"Day 1 - 21：Atorvastatin calcium 80mg/day
~Day 22 - 90：Atorvastatin calcium 40mg/day"
15901791|NCT03635749|Drug|Delayed high-intensity statin|"Day 1 - 3：Atorvastatin calcium placebo
~Day 4 - 21：Atorvastatin calcium 40mg/day + Atorvastatin calcium placebo
~Day 22 - 90：Atorvastatin calcium 40mg/day"
15901792|NCT03635736|Other|multiple-spectral-sonography as acustocerebrography (ACG)|After inclusion three times at day measurements with ACG for each 45 minutes; a (non-invasive) sonography. The measurements will be stopped after final evaluation of the neurological status using common methods like magnetic resonance tomography, transcranial doppler sonography, electroencephalography and other methods.
15901793|NCT03635710|Device|The patient will undergo no intervention|Night coughs will be monitored using smartphone a app and interpreted using machine learning algorithm.
15901798|NCT03635658|Procedure|collagen membrane (Sausage technique)|the resorbable collagen membrane is used to fix the 1:1 mixture of autograft and xenograft particulate bone on the severely atrophies maxillary ridge.
15901799|NCT03635645|Device|New visual processing unit (VPU) with asymmetric waveforms|A VPU will apply asymmetric and symmetric stimulation pulses.
15901800|NCT03635645|Device|New VPU with bipolar stimulation|A VPU will apply bipolar stimulus pulses.
15901801|NCT03635632|Genetic|C7R-GD2.CART cells|"Dose Level 0: 1 x 10^7 C7R-GD2.CART cells without Lymphodepletion
~Dose Level 1: 1 x 10^7 C7R-GD2.CART cells with Lymphodepletion
~Dose Level 2: 3 x 10^7 C7R-GD2.CART cells with Lymphodepletion
~Dose Level 3: 1 x 10^8 C7R-GD2.CART cells with Lymphodepletion"
15901802|NCT03635632|Drug|Cyclophosphamide|If patients receive lymphodepletion, they will receive 2 daily doses of cyclophosphamide (500mg/m2/day) finishing at least 24 hours before T-cell infusion. The drug will be given intravenously (through an IV needle).
15901803|NCT03635632|Drug|Fludarabine|If patients receive lymphodepletion, they will receive 3 daily doses of fludarabine (30mg/m2/day) finishing at least 24 hours before T-cell infusion. The drug will be given intravenously (through an IV needle).
15901804|NCT03635619|Other|No intervention|No intervention
15901805|NCT03635593|Drug|CBD|Participants will be randomized to CBD 10mg capsules for 12 weeks. Participants will start with 1, CBD (10mg) capsule per day and self-titrate up to 8, 10mg CBD capsules (80mg) per day as needed.
15901806|NCT03635593|Drug|CBD+THC|Participants will be randomized to CBD+THC 10mg (CBD 5mg + THC) for 12 weeks. Participants will start with 1, 10mg CBD+THC (5mg+5mg) capsule per day and self- titrate up to 8, 10mg CBD+THC (5mg+5mg) capsules to a maximum of 80mg (40mg CBD + 40mg THC) per day as needed.
15901807|NCT03635593|Other|Placebo|Participants randomized to placebo 10mg capsules for 12 weeks. Participants will start with 1, 10mg placebo capsule per day and self-titrate up to 8 10mg placebo capsules (80mg) per day.
15901808|NCT03635580|Other|Negative control|Untreated-control group
15901809|NCT03635567|Biological|Pembrolizumab|IV infusion
15901810|NCT03635567|Drug|Paclitaxel|IV infusion
15901811|NCT03635567|Drug|Cisplatin|IV infusion
15901812|NCT03635567|Drug|Carboplatin|IV infusion
15901813|NCT03635567|Biological|Bevacizumab|IV infusion
15901814|NCT03635567|Drug|Placebo to pembrolizumab|IV infusion
15901815|NCT03635541|Other|observational group of NAFLD|there's no intervention for patients for it is a observational study
15901816|NCT03635528|Device|Test Lens 1|EMO-114
15901817|NCT03635528|Device|Test Lens 2|EMO-116
15901818|NCT03635528|Device|Test Lens 3|EMO-118
15901819|NCT03635528|Device|Test Lens 4|RMY-100
15901820|NCT03635528|Device|Test Lens 5|Biofinity multifocal D Lens
15901821|NCT03635528|Device|Control Lens 1|EMO-117
15901822|NCT03635528|Device|Control Lens 2|Proclear 1 day
15901823|NCT03635515|Device|Gentlewave|The Gentlewave system from Sonendo is a FDA cleared root canal irrigation device that uses broad spectrum acoustic energy, internally degassed distilled water, 3% NaOCl, and 8% EDTA to allow for a more thorough cleaning within the tooth. The fluids work to remove necrotic tissue, debris, biofilm, and bacteria while leaving dentin intact and preserving tooth structure. The Gentlewave irrigation replaces the NaOCl ultrasonic activation and EDTA steps of the standard endodontic protocol. Use of the Gentlewave system is contraindicated in teeth with immature apices, teeth with insufficient coronal structure, and teeth with root apices extending into the maxillary sinus.
15901824|NCT03635515|Procedure|Standard Endodontic Protocol|The tooth will be sufficiently anesthetized with local anesthetic. The tooth will be rubber dam isolated. The pulp chamber will be accessed removing all caries, defective restorations, and defective crowns. EAL and radiographs will be used to determine the working length of each canal, all canals will be cleaned and shaped using rotary files to at least a size 25.04 canal size to within 0.5 to 1 mm of the apical terminus. Between each file 5.25% NaOCl will be used to disinfect and clear the canals of debris. A final passive ultrasonic activation of NaOCl will be done for 30 seconds per canal. Each canal will then soak in 17% EDTA for 1 minute, rinsed in 5.25% NaOCl, and finally undergo a final rinse of 95% ethanol. Canals will be obturated with root canal sealer and gutta-percha.
15901825|NCT03635489|Drug|Paclitaxel|175 mg/m^2 IV infusion on Day 1 of each 21-day cycle.
15901826|NCT03635489|Drug|Bevacizumab|15 mg/kg IV infusion on Day 1 of each 21-day cycle.
15901827|NCT03635489|Drug|Carboplatin|Area Under the Curve (AUC) of 6 mg/ml/min on Day 1 of each 21-day cycle.
15901828|NCT03635489|Drug|Placebo|Placebo matched to bevacizumab IV infusion on Day 1 of each 21-day cycle.
15901829|NCT03635476|Other|Qualitative interview study|The group in question is part of a research program aimed at developing and evaluating the LIFANA Nutrition Solution, a meal planning recommended system, which suggests meals based on the user's personal profile. This may include general preferences, such as culture, taste, and budget, but more importantly automated and personalised nutritional recommendations based on advice provided by professional nutritionists and allergists.
15901830|NCT03635463|Device|twin block appliance|a functional appliance that enhances mandibular growth in growing patients made from vaccum sheets (esthetic)
15901831|NCT03635463|Device|modified twin block appliance|a convetional twin block functional appliance that enhances mandibular growth in growing patients
15901832|NCT03635450|Biological|Infusion of hCT-MSC|Infants who meet enrollment criteria for moderate to severe hypoxic ischemic encephalopathy will receive 1 infusion of hCT-MSC within the first 48 postnatal hours. hCT-MSCs are a product of allogeneic cells manufactured from digested umbilical cord tissue that is expanded in culture, cryopreserved and banked. hCT-MSCs are manufactured from umbilical cord tissue donated to the Carolinas Cord Blood Bank, an FDA-licensed, FACT-accredited, public cord blood bank at Duke University Medical Center, after written informed consent from the baby's mother. Cord tissue is harvested from the placentas of male babies delivered by elective C-section after a normal, full- term pregnancy.
15901865|NCT03635138|Other|Metal nanoparticles ( O Zn and Cu)|Np of OZn nanoparticles mixed with dental adhesive
15901866|NCT03635138|Other|Dental Adhesive pure|Dental Adhesive with commercial preparation
15901833|NCT03635437|Drug|Gamma-Aminobutyric Acid (GABA)|Patients eligible for the main study will be randomized in a 1:1:1 ratio stratified by the C-peptide level to receive 200 mg of GABA (Remygen) for 6 months, 600 mg of GABA (Remygen) for 6 months, or Alprazolam 0.5 mg combined with GABA 600 mg (Remygen) for 3 months followed by treatment with GABA 600 mg (Remygen) only for another 3 months. The start of the arms with high dose GABA will be delayed and started first after that a data safety monitoring board has evaluated and approved the safety data of the first 4 patients included in the arm with low dose GABA. All patients will continue to receive intensive insulin treatment from their personal physicians during the whole study period.
15901834|NCT03635437|Drug|Alprazolam|Patients eligible for the main study will be randomized in a 1:1:1 ratio stratified by the C-peptide level to receive 200 mg of GABA (Remygen) for 6 months, 600 mg of GABA (Remygen) for 6 months, or Alprazolam 0.5 mg combined with GABA 600 mg (Remygen) for 3 months followed by treatment with GABA 600 mg (Remygen) only for another 3 months. The start of the arms with high dose GABA will be delayed and started first after that a data safety monitoring board has evaluated and approved the safety data of the first 4 patients included in the arm with low dose GABA. All patients will continue to receive intensive insulin treatment from their personal physicians during the whole study period.
15901836|NCT03635411|Dietary Supplement|Nicotinamide Riboside and Pterostilbene|Nicotinamide riboside and pterostilbene manufactured by Basis
15901837|NCT03635411|Dietary Supplement|Placebo|Sugar pill manufactured to mimic Basis supplement.
15901838|NCT03635398|Device|Sipnose device|SipNose's intranasal drug delivery platform uses an innovative mechanism that is suposed to improves efficacy, patient compliance and safety
15901839|NCT03635398|Device|MAD (Mucosal Atomization Device)|MAD (Mucosal Atomization Device)
15901840|NCT03635398|Drug|midazolam|oral administration of midazolam
15901841|NCT03635385|Procedure|Apheresis technics|Blood draw will be performed for anti bodies dosages
15901842|NCT03635372|Drug|Alginate|10 cc of Alginate peroral
15901843|NCT03635372|Drug|Sucralfate|10 cc of Sucralfate peroral
15901844|NCT03635372|Drug|Hydrotalcite|10 cc of Hydrotalcite peroral
15901845|NCT03635359|Diagnostic Test|blood test|analysis of cell-free DNA in maternal plasma
15901846|NCT03635333|Drug|Nicotine|Nicotine level (6 or 18 mg)
15901847|NCT03635333|Drug|Flavor|Flavor of e-juice (tobacco, menthol, strawberry)
15901848|NCT03635320|Device|TFNA|intramedullary nail 'Trochanteric Fixation Nail Advanced' to treat proximal femur fracture undergoing internal fixation
15901849|NCT03635320|Device|PFNA-II|intramedullary nail ' Proximal Femoral Nail Antirotation' to treat proximal femur fracture undergoing internal fixation
15901850|NCT03635307|Other|End Tidal Carbon Dioxide measure|End Tidal Carbon Dioxide measures before and after a volume expansion of 250ml of crystalloid in the operating room.
15901851|NCT03635294|Other|Blood sample|combining genomics, transcriptomics, metabolomics and morphological analyses performed on induced pluripotent stem cell (iPSC)-derived neural cells
15901852|NCT03635281|Procedure|Recruitment manoeuvers|"Recruitment manoeuvers will be performed as follow Recruitment manoeuvers
~set FIO2 at 1.0
~Ppeak limit at 45 cmH2O
~Respiratory rate set at 6
~I:E set at 1:1
~Raise the VT at step of 2 ml/kg PBW until the Pplat is between 30-40 cmH2O
~If the maximum VT is set without rasing the Pplat, raise PEEP
~Allow three respiratory cycles with Pplat between 30 and 40 cmH2O
~End of RM
~The recruitment manouvers will be performed after 20 minutes of OLV. At the end of the RM, the VT will be set back to 5 ml/kg while the PEEP will be chosen according to the best static compliance with a decremental trial (from 16 cmH2O, lowering PEEP with steps of 2 cmH2O each until the best compliance is reached)."
15901853|NCT03635281|Procedure|incremental PEEP|In this group the a PEEP level will be added after 20 minutes from OLV. PEEP values will be chosen according to the best static compliance with an incremental trial (i.e. starting from ZEEP, the PEEP values will be increased in step of 2 cmH2O each until the best compliance is reached
15901854|NCT03635268|Other|Data collection|Sociodemographic, medical and hospital, on ambulatory care consumption data.
15901855|NCT03635242|Other|Control. no therapeutic program|The control group continued to perform their daily activities without changing any habit. Group of healthy subjects Assessment of postural control through accelerometry and pressure platform
15901856|NCT03635242|Other|Experimental. Therapeutic program|"People with chronic back pain of at least 3 months duration, to whom the therapeutic exercise of motor control and pain education based on neuroscience will be applied 2 days a week for 2 months.
~Prior to the intervention, a postural control assessment will be made by accelerometry and pressure platform"
15901857|NCT03635203|Device|CBCT|Observation of C-shaped root canal in mandibular first and second molars in Egyptian sub-population
15901858|NCT03635190|Device|Orbital Circumferential Atherectomy|Remove atherosclerotic plaque and modify vessel wall compliance within peripheral arterial vessels. The therapy is intended for patients who are acceptable candidates for percutaneous transluminal atherectomy.
15901860|NCT03635164|Drug|Durvalumab|Patients will receive one dose of neoadjuvant durvalumab 1500 mg approximately 3-6 weeks prior to standard of care surgery. It will be given concurrently with the first dose of radiation (RT). Patients will receive up to six doses of durvalumab and radiation post-operatively.
15901861|NCT03635164|Radiation|Stereotactic Body Radiation Therapy (SBRT)|The starting RT dose level will be given as 6 Gy for 2 fractions (12 Gy total) every other day over approximately one week to sites of gross disease only to minimize exposure to normal tissue. If toxicity develops and surgery is delayed by more than 8 weeks (qualifying as a DLT), the radiation dose will be dropped per protocol for the next set of patients. If this dose is tolerated, the dose will be increased to 6 Gy for 3 fractions (18 Gy total) for the next 3 patients.
15901862|NCT03635164|Procedure|Standard of Care Therapy|Patients will proceed to surgical resection 3-6 weeks after radiation as recommended by the ENT surgeon.
15901868|NCT03635125|Drug|Nebivolol II|Low dose treatment phase: Nebivolol 10 mg or Metoprolol 50 mg High dose treatment phase: Nebivolol 20mg or Metoprolol 100mg
15901869|NCT03635125|Other|Baseline Washout Phase|2 to 4 week Baseline Washout Phase
15901872|NCT03635099|Drug|BI 730357|Film-coated tablet
15901873|NCT03635099|Drug|Placebo|Film-coated tablet
15901879|NCT03635073|Drug|TAK-935|TAK-935 tablets or mini-tablets.
15901880|NCT03635060|Procedure|Dorsal Bridge Plating|This study will be a pilot randomized control trial that will focus on treating patients with the described fracture pattern either with dorsal distraction plating with or without any additional fragment specific fixation or standard open reduction internal fixation.
15901881|NCT03635060|Procedure|Volar locking plating|This study will be a pilot randomized control trial that will focus on treating patients with the described fracture pattern either with dorsal distraction plating with or without any additional fragment specific fixation or standard open reduction internal fixation.
15901882|NCT03635047|Biological|AL002|Single-doses of AL002 in up to 9 dose-escalating cohorts
15901883|NCT03635047|Other|Saline Solution|Saline solution will be administered as a single infusion for each cohort in a ratio of 6 active and 2 placebo subjects for HV and 10 active and 2 placebo for patients
15901884|NCT03635034|Device|Insert bladder catheter|Bladder catheter will be inserted according to randomization schema
15901885|NCT03635034|Device|No catheter|Subjects will not receive a bladder catheter during the ablation procedure
15901886|NCT03635021|Drug|FOLFOX regimen|oxaliplatin 85 mg/m2 administered by IV infusion over 120 minutes on Day 1, L-leucovorin 200 mg/m2 administered as a 2-hour IV infusion on Day 1 and 5-FU 400 mg/m2 administered as IV bolus over approximately 2 to 4 minutes on Day 1 followed by 5-FU 2400 mg/m2 administered as IV infusion over 46- 48 hours on Days 1 and 2
15901887|NCT03635021|Drug|Panitumumab|6 mg/kg administered by intravenous (IV) infusion over 60 minutes on Day 1 of each 14-day cycle
15901888|NCT03635021|Drug|Bevacizumab|5 mg/kg administered by IV infusion over 60 minutes on Day 1 of each 14-day cycle
15901889|NCT03635021|Drug|FOLFIRI regimen|irinotecan 180 mg/m2 administered as a 90 minutes IV infusion on Day 1, L-leucovorin 200 mg/m2 administered as a 2-hour IV infusion on Day 1 and 5-FU 400 mg/m2 administered as IV bolus over approximately 2 to 4 minutes on Day 1 followed by 5-FU 2400 mg/m2 administered as IV infusion over 46-48 hours on Days 1 and 2
15901890|NCT03635008|Device|tDCS|Regard to the anodal tDCS, the anode will be placed over the contralesional premotor area (2.5 cm anterior to the C3 or C4 in 10-20 EEG system) and cathode will be placed over the contralateral supraorbital area. The stimulation intensity will be 2mA. For the sham tDCS the stimulation will be applied for just first 30 seconds.
15901891|NCT03634995|Drug|BMS-986256|Specified dose on specified days
15901892|NCT03634995|Other|Placebo|Specified dose on specified days
15901893|NCT03634982|Drug|RMC-4630|RMC-4630 for oral administration
15901894|NCT03634969|Drug|BMS-986224|Specified dose on specified days
15901895|NCT03634956|Drug|Group B. Sugammadex sodium-IONM|Group B.the vagal nerve is detected and then 2 mg / kg of sugammadex sodium is administered to remove the muscle relaxant effect
15901896|NCT03634943|Other|Patients with Nutritional Support|Evaluation of Enteral Nutrition or Parenteral Nutrition or both administered to the patients needing artificial Nutritional Support
15901897|NCT03634930|Behavioral|observation|Observation of growth, infant bodycomposition, 24h-drinkingvolume
15901898|NCT03634917|Drug|Acamprosate Calcium|1 capsule with 666 mg Acamprosate
15901899|NCT03634917|Drug|Calcium Carbonate|1 capsule with 1500 mg Calcium Carbonate
15901900|NCT03634917|Drug|Placebo|1 Capsule with Placebo (lactose monohydrate, micro crystalline cellulose, magnesium stearate)
15901901|NCT03634917|Drug|Placebo lead in|1 Capsule with Placebo (lactose monohydrate, micro crystalline cellulose, magnesium stearate)
15901902|NCT03634904|Drug|Drug bood sampling|"Total: 6 per patient
~after the first administration of ceftazidime (loading dose): sampling #1: at trough before 1st dialysis; sampling #2: after the end of the dialysis session;
~after the second administration of ceftazidime (maintenance dose): sampling #3: at trough before 2d dialysis session;
~after the third administration of ceftazidime (maintenance dose): sampling #4: at trough before 3d dialysis session;
~after the fourth third administration of ceftazidime (maintenance dose): sampling #5: at trough before 4th dialysis session; sampling #6: after the end of the dialysis session"
15901903|NCT03634878|Other|perineal ultrasound|Ultrasound measurement of the size and position of the prostheses.
15901904|NCT03634852|Drug|Moxifloxacin hydrochloride 0.5% eye drops|were prescribed four times a day for 1-month postoperatively
15901905|NCT03634852|Drug|Dexamethasone 0.1% eye drops|were prescribed four times a day for 1-month postoperatively
15901971|NCT03634397|Behavioral|Less-Impaired Arm Training|Participants receive virtual reality and manipulation training in their less impaired arm.
15902074|NCT03633591|Drug|Tolcapone Divided Dose|Tolcapone (suspension) in equal divided doses in the fasted state
15901906|NCT03634852|Drug|Intracameral Moxifloxacin 0.1%|"Auromox (0.5%): is a sterile clear yellow pale colored preservative free isotonic ophthalmic solution with pH 6.0 to 7.5 and osmolarity 620 -320 milliosmol ( mOsm).The sterile Auromox vial contains 1cc Moxifloxacin hydrochloride 5.45 mg equivalent to 5mg of Moxifloxacin. This product is manufactured by Aurolab an Indian pharmaceutical company. Auromox is available in many countries including Iraq.
~Each vial enough for 15 different patients by using a sterile needle and 5cc syringe. By the sterile hand's, the surgeon draws the whole 1cc of Moxifloxacin 0.5% and diluted with 4 cc of balanced salt solution (BSS) to get 5 mg in 5 cc (0.1%) then draw 0.2 cc for each patient."
15901907|NCT03634852|Drug|Subconjunctival Triamcinolone acetonide 4 mg /0.4 ml|"Aurocort is a preservative-free Triamcinolone acetonide (40 mg /1cc), with along acting depot preparation of triamcinolone in 1cc vial also the product of Aurolab company and commercially available in our country.
~The whole 1cc had been drawn and diluted with 3cc of BSS and SC injection of 4 mg in 0.4 cc of Triamcinolone was given (as a final step in the surgery) 6mm from the limbus usually an inferotemporal site that is easily accessible and the plaque that formed will be not visible within palpebral fissure"
15901908|NCT03634839|Drug|Flavor|Flavor of e-liquid - sweet or tobacco
15901909|NCT03634839|Drug|Nicotine|Nicotine level (0, 3, or 12 mg)
15901910|NCT03634813|Device|High Blood Pressure Monitor|High Blood Pressure Monitoring device (Omron MX3 model BP742, Omron, Shaumberg, IL)
15901911|NCT03634813|Procedure|Usual Care|Usual Care
15901912|NCT03634800|Drug|Nivolumab 240mg|Patients with multiple myeloma will receive Nivolumab intravenously at 240 mg every two weeks. Infusions will be given over 60 minutes (not bolus or IV push). Patients will continue to receive infusions every two weeks until disease progression or dose limiting toxicity is reached.
15901913|NCT03634800|Radiation|Radiation therapy|Patients will receive radiation for 5 consecutive days. A dose of 6 Gy x 5 days will be administered. Patients may receive radiotherapy to an additional site at 12 weeks if they have stable disease.
15901914|NCT03634787|Diagnostic Test|CT Scan Day 5-7|Computed Tomography on Day 5-7 according to a clinical protocol.
15901915|NCT03634774|Other|CHOICE+ Training Program|CHOICE+ is a program where team members and other stakeholders are engaged in making changes to dining in a long term care home to improve the experience. An external coach supports behaviour change.
15901916|NCT03634761|Behavioral|Competency based model|Qualified Learning course and workshop to preschool staff combined with monthly on-site coaching at preschool sites to improve overall intervention setting quality and use of evidence bases practices, provided by external expert from habilitation center.
15901917|NCT03634761|Behavioral|Comprehensive program|Comprehensive program of EIBI for Children with ASD supervised by external expert from habilitation center (treatment as usual)
15901918|NCT03634735|Drug|Thiamine|Vitamine B1
15901919|NCT03634735|Other|Placebo|Placebo tablets
15901920|NCT03634722|Device|PHENIX4-8-8 PLUS|transcutaneous electrical nerve stimulation by PHENIX4-8-8 PLUS
15901921|NCT03634709|Behavioral|Memory Flexibility training (MemFlex)|MemFlex is a primarily self-guided, paper workbook-based program which aims to reduce overgeneral memory bias and improve recall of positive, specific event memories. Prior to completing one month of self-guided, workbook-based intervention, the participant will attend one 45 minute face-to-face session in which the facilitator outlines the importance of autobiographical memory in everyday life, discusses the impact of trauma on autobiographical memory, and provides information on the different types of autobiographical memories (e.g., specific, general) and their potential everyday functions. The session also introduces the cued-recall tasks which were used to train the memory skills throughout the workbook, and provides facilitator-assisted practice with the tasks. Once participants are comfortable with the training exercises, they set a schedule for completion of the eight-session workbook over the following four weeks.
15901922|NCT03634696|Other|mPCL|Smart phone application to support palliative care among late-stage cancer patients
15901923|NCT03634696|Other|Usual Care|Usual care through OCRI palliative care clinic
15901924|NCT03634683|Biological|LioCyx|Autologous T cells transfected with mRNA encoding HBV antigen-specific TCR
15901925|NCT03634670|Other|Interdisciplinary multimodal pain therapy (IMPT)|The IMPT-program is provided in a specialized day-clinic setting over a period of 20 treatment days. There are two different treatment programs with either 5 days per week over a period of 4 weeks or 3 days per week over a period of 7 weeks. IMPT comprises individual pharmacotherapy evaluated in regular consultations with a physician as well as a structured physiotherapy and psychotherapy programs on group level and individual level. Group physiotherapy comprises exercise therapy, movement experience and relaxation techniques. Additionally individual physiotherapy is provided in two extra sessions focusing on the individual needs and problems of the patient. Group psychotherapy comprises educational contents (e.g. pathophysiology and biopsychosocial aspects of pain) as well as cognitive-behavioral-interventions e.g. regarding stress-management. Additionally individual psychotherapy is provided in four extra sessions focusing on the individual needs and problems of the patient.
15901926|NCT03634657|Radiation|Plain X-ray protection shield|Coronary angiography with mere X-ray protection shield
15901927|NCT03634657|Radiation|Protection shield & X-ray protective strips|Coronary angiography with X-ray protection shield & X-ray protective strips
15901928|NCT03634657|Radiation|Protection shield & protective strips & patient cut-outs|Coronary angiography with X-ray protection shield & X-ray protective strips & X-ray protection patient cut-outs
15901929|NCT03634644|Drug|Omega 3 fatty acid|Omega 3 fatty acid,mainly composed of EPA and DHA.
15901930|NCT03634644|Drug|Placebo oral capsule|mainly composed of corn oil
15901931|NCT03634631|Other|Focused Ultrasound|Test ultrasound in 7T MRI scanner
15901932|NCT03634618|Other|Mirror Therapy|Mirror therapy is the treatment method in which mental performance of movements is performed by observing the movements of the healthy extremities. In the case of mirror treatment, the mirror box is placed on a fixed floor. The mirror is positioned so that the patient's body can be fully centered and the mirror image can be seen. While the affected limb is placed on the rear side of the mirror, the firm extremity is opposite to the mirror. The patient focuses on the mirror image of the moving healthy hand and, through artificial visual feedback, perceives the affected limb as moving. The exercises are as follows: flexor tendon gliding exercises, median motor exercises, wrist and forearm ROM exercises and function-oriented exercises.
15902068|NCT03633630|Drug|Placebo|Capsules of 500 mg two times per day before breakfast and dinner a total dose of 1000 mg per day. During 90 days
15901933|NCT03634618|Other|Convantional Physiotherapy|The first two weeks involve only immobilisation with plaster. The next 4 weeks, patients do the exercises which follows: 15 minutes water bath, scar tissue massage, flexor tendon gliding exercises, median motor exercises, wrist flexion-extention, median nerve gliding exercise (in addition, one week after plaster removal), hand wrist stretching exercise (in addition, 2 weeks after plaster removal).
15901934|NCT03634605|Procedure|Chemical pleurodesis|
15901935|NCT03634605|Drug|Tetracycline Topical Ointment|
15901936|NCT03634605|Drug|Normal saline|
15901937|NCT03634605|Drug|Lidocaine 2% Injectable Solution|
15901938|NCT03634592|Procedure|Catheter ablation|Radiofrequency catheter pulmonary vein isolation
15901939|NCT03634579|Device|MRI Guided Focal Laser Interstitial Thermal Ablation|"The procedure is done under general anesthesia. Laser fiber placement will be performed by one of two approaches (Trans gluteal or trans rectal) based on the target location within the prostate gland. When the needle position is deemed satisfactory, a 1.5-cm-active tip diode laser fiber will be introduced within an internally cooled catheter through the introducing sheath.
~The catheter tip location will be confirmed on Turbo Spin-Echo (TSE) T2-weighted images in the axial and sagittal oblique planes.The introducer sheath will be withdrawn to allow contact of the active laser tip with the lesion. A laser test dose will be done at 9 Watts for about 30 seconds to confirm the site of fiber placement with the subsequent delivery of full dose ablation at 12-27 Watts. Ablation duration is determined based on real time feedback of response using real time temperature and damage estimate maps."
15901940|NCT03634566|Drug|N-Acetylecysteine|N-Acetylecysteine 150 mg/kg diluted in 100 ml glucose 5 % over 40 minutes followed by NAC 12.5 mg/kg in 500 ml glucose 5% over 4 hours, followed by NAC 6.25 mg/kg for 2 postoperative days
15901941|NCT03634566|Drug|Placebo|Ringer acetate continuous infusion at the same rate for 2 days.
15901942|NCT03634553|Other|Training with e-health product|The training program follows the recommendations for training from ACSMS and SoS who states the importance that exercise programs should include muscle strengthening, cardiovascular as wells as balance exercises. Therefore, the training program includes: Strengthening exercises for the upper and lower extremities (number: 5-8 pc. with progression in three levels), daily (5-7 times / week), 30 minutes walks and balance training.
15901943|NCT03634553|Other|Usual care|usual care, i.e. participates in regular training regime at the physiotherapy department
15901944|NCT03634540|Drug|Belzutifan|Belzutifan tablets administered orally.
15901945|NCT03634540|Drug|Cabozantinib|Cabozantinib tablets administered orally.
15901946|NCT03634527|Behavioral|Auricular Point Acupressure|Light touch using vaccaria seeds on specific points of the ear
15901947|NCT03634527|Behavioral|Control Auricular Point Acupressure-|Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
15901948|NCT03634514|Drug|Recombinant human growth hormone - Biomatrop|The subjects who recieve Biomatrop first, after a period maximum of 24 hours will recieve a dose of Hormotrop.
15901949|NCT03634514|Drug|Recombinant human growth hormone - Hormotrop|The subjects who recieve Hormotrop first, after a period maximum of 24 hours will recieve a dose of Biomatrop.
15901950|NCT03634501|Biological|Activated NK|Cell suspension
15901951|NCT03634488|Drug|hydroxyurea (20mg/kg/day)|Treatment of severe malnutrition in children with SCA in northern Nigeria
15901952|NCT03634488|Dietary Supplement|Nutritional Supplement|Treatment of severe malnutrition in children with SCA in northern Nigeria per local protocol with SoyaPlus
15901953|NCT03634475|Drug|PP-001|Drug - no placebo
15901954|NCT03634462|Other|CDT with graded negative pressure|Complete Decongestive Therapy (CDT)is a common conservative intervention involving stimulation of the lymphatic system, use of compression, skin care and exercise. The use of graded negative pressure in conjunction with CDT is another conservative therapy intervention used to help clear the lymphatic congestion.
15901955|NCT03634449|Device|i-gel|i-gel is a supraglottic airway devices with a gastric suction channel.
15901956|NCT03634449|Device|endotracheal tube|Endotracheal intubation is a traditional use for protect airway during the laparoscopic surgery.
15901957|NCT03634436|Drug|SHR-1209|"Pharmaceutical form: lyophilized formulation
~Route of administration: subcutaneous"
15901958|NCT03634436|Drug|Placebo|"Pharmaceutical form: lyophilized formulation
~Route of administration: subcutaneous"
15901959|NCT03634423|Behavioral|Sweet Spot: Flexible high incentive condition|Participants receive text reminders 30 minutes before their workouts and weekly emails reminding them of their schedule.
15901960|NCT03634423|Behavioral|Sweet Spot: Flexible low incentive condition|Participants receive text reminders 30 minutes before their workouts and weekly emails reminding them of their schedule.
15901961|NCT03634423|Behavioral|Sweet Spot: Rigid high incentive condition|Participants receive text reminders 30 minutes before their workouts and weekly emails reminding them of their schedule.
15901962|NCT03634423|Behavioral|Sweet Spot: Rigid low incentive condition|Participants receive text reminders 30 minutes before their workouts and weekly emails reminding them of their schedule.
15901963|NCT03634423|Behavioral|FOTW: High incentive control condition|Participants receive text reminders 30 minutes before their workouts and weekly emails reminding them of their schedule.
15901964|NCT03634423|Behavioral|FOTW: Low incentive control condition|Participants receive text reminders 30 minutes before their workouts and weekly emails reminding them of their schedule.
15901965|NCT03634423|Behavioral|FOTW: High incentive treatment condition|Participants receive text reminders 30 minutes before their workouts and weekly emails reminding them of their schedule.
15901966|NCT03634423|Behavioral|FOTW: Low incentive treatment condition|Participants receive text reminders 30 minutes before their workouts and weekly emails reminding them of their schedule.
15901967|NCT03634423|Behavioral|Think Twice: Control condition|Participants receive text reminders 30 minutes before their workouts and weekly emails reminding them of their schedule.
15901968|NCT03634423|Behavioral|Think Twice: Treatment condition|Participants receive text reminders 30 minutes before their workouts and weekly emails reminding them of their schedule.
15901969|NCT03634423|Behavioral|WDR: Control condition|Participants receive text reminders 30 minutes before their workouts and weekly emails reminding them of their schedule.
15901970|NCT03634423|Behavioral|WDR: Treatment condition|Participants receive text reminders 30 minutes before their workouts and weekly emails reminding them of their schedule.
15901972|NCT03634397|Behavioral|Contralesional Arm Comparison|Participants receive therapy in their paretic arm, based on the best-practices framework for arm recovery post stroke.
15901973|NCT03634371|Drug|Drug Levothyroxine 150 mcg|Administration of a 600 mcg levothyroxine dose
15901974|NCT03634371|Drug|Drug Eutirox 150 mcg|Administration of a 600 mcg levothyroxine dose
15901975|NCT03634358|Procedure|Bipolar scissors|
15901976|NCT03634358|Procedure|classic scalpel|
15901977|NCT03634345|Drug|Period 1 - Day 1: PF-04965842 administered|Period 1: Single administration of 100 mg PF 04965842.
15901978|NCT03634345|Drug|Period 2: Cohort 1: Fluvoxamine & PF-04965842|Cohort 1: Period 2: Administration of fluvoxamine from Day 1 to Day 9 and PF-04965842 on Day 8.
15901979|NCT03634345|Drug|Period 2: Cohort 2: Fluconazole & PF-04965842|Cohort 2: Period 2: Administration of fluconazole from Day 1 to Day 7 and PF-04965842 on Day 5.
15901980|NCT03634332|Drug|PEGPH20|PEGPH20 is a PEGylated, neutral-pH-active human hyaluronidase PH20 produced by recombinant DNA technology
15901981|NCT03634332|Biological|Pembrolizumab|Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2
15901982|NCT03634319|Device|Beacon Aqueous Microshunt|"The Beacon Aqueous Microshunt is an implantable device designed to lower intraocular pressure (IOP) in glaucoma patients by shunting aqueous humor from the anterior chamber of the eye to the surface of the eye.
~Because there are no physiologic sources of outflow resistance, the device can be engineered to target an IOP that is low enough to halt the progression to blindness in a patient suffering from glaucoma."
15901983|NCT03634306|Device|Ultravision System|Laparoscopic surgery will be performed with the Ultravision Visual Field Clearing System. This system is indicated for the clearance of smoke and other particulate matter that is created during laparoscopic surgery. Ultravision Visual Clearing System removes surgical smoke by means of electrostatic precipitation.
15901984|NCT03634306|Procedure|Laparoscopic Hysterectomy|Laparoscopic hysterectomy will be performed according to standard of care without the Ultravision Visual Field Clearing System
15901985|NCT03634293|Drug|Alirocumab Injectable Product|Alirocumab is an human monoclonal antibodies directed against Proprotein convertase subtilisin/kexin type 9 (PCSK9). It is administered once every two weeks subcutaneously.
15901986|NCT03634293|Drug|Saline Solution|The placebo will be 2 ml' of 0.9% saline injected subcutaneously.
15901987|NCT03634280|Other|Kinesio taping|In patients in the splint group, 16-18 layers of cotton gauze (15-cm cast gauze) were applied from the tip of the toes to the beginning of the fibula. Following the gauze application, short leg splint application was performed in a neutral ankle position.
15901988|NCT03634267|Radiation|Internal Radiation Therapy|Undergo brachytherapy
15901989|NCT03634267|Procedure|Magnetic Resonance Imaging|Undergo MRI scan
15901990|NCT03634254|Other|Satisfaction survey of communication quality:|a conversation from phone call to survey primary caregivers of AAC users in New Taipei City who think the users communication quality
15901991|NCT03634241|Other|Best Practice|Receive standard of care
15901992|NCT03634241|Biological|Pembrolizumab|Given IV
15901993|NCT03634241|Other|Quality-of-Life Assessment|Ancillary studies
15901994|NCT03634228|Drug|Cytarabine|Given SC
15901995|NCT03634228|Drug|Milademetan Tosylate|Given PO
15901996|NCT03634228|Drug|Venetoclax|Given PO
15901997|NCT03634215|Diagnostic Test|fibrinogen plasma concentration, coagulation factor XIII activity|blood sampling for a routine coagulation test
15901998|NCT03634202|Combination Product|IMRT + oral chemotherapy|"It's a dose escalation of radiation (IMRT), during 5 to 7 weeks, 5 days per week.
~Concomitantly, patient have oral chemotherapy (capecitabin)"
15901999|NCT03634189|Drug|Cannabidiol|Patients with ACC/AHA stage A-C will receive 5 mg/kg to a maximum tolerated dose of 25 mg/kg PO BID of Cannabidiol
15902000|NCT03634176|Diagnostic Test|optical nerve sheet diameter|The ONSD in each eye was measured vertically and horizontally 3 mm behind the optic disc, with the two values averaged. No pressure was applied to the orbit. At each time point, measurements were taken within 5 min. The measurements were made before (T1) and after some of the strategies according to group 30 min (T2), 60 min (T3), and 90 min (T4).
15902001|NCT03634163|Behavioral|Neighbourhood exchange|Facilitated coaching support to identify needs and priorities and link with resources - personal, community, friend and family, or from professional service providers; plan and implement a personalized care pathway through community exchange
15902002|NCT03634163|Behavioral|Quality of Life Assessment|Completion of baseline measures
15902004|NCT03634137|Drug|Afamelanotide Group 1|One 16 mg bioresorbable afamelanotide implant (Group 1) from the previous manufacturing process.
15902005|NCT03634137|Drug|Afamelanotide Group 2|One 16 mg bioresorbable afamelanotide implant (Group 2) from the optimized final manufacturing process.
15902006|NCT03634124|Biological|Blood test|Additional blood test of 4,5 ml of venous blood
15902007|NCT03634124|Other|Doppler ultrasound|Vascular ultrasonic vascular exploration of the lower limbs
15902008|NCT03634111|Procedure|TAP block|TAP block was performed under guidance with 0.25% ropivacaine 20 ml each side.
15902009|NCT03634111|Drug|Morphine|Single dose was 1 mg. The locked time was 6 minutes. The limited dose was 40 mg/ 4 giờ.
15902010|NCT03634111|Drug|Ropivacaine|Ropivacaine 0.25% 20 ml each side
15902011|NCT03634098|Device|new quantitative imaging techniques with contast products|magnetic resonance +/- Primovist and ultrafast ultrasound UFUS +Sonovue
15902012|NCT03634098|Diagnostic Test|blood sample|extensive clinical-biological phenotyping data; and / or data obtained by different omic approaches (metabolomics, targeted genetics, transcriptomics). Extracellular vesicle and immune cell profiling will complement this data
15902013|NCT03634098|Diagnostic Test|second generation tests|second generation tests NIT-NASHr et NIT-A2F2
15902014|NCT03634085|Drug|BDM-2 in Bottle (50 mg - 3600 mg); oral suspension|BDM-2 in bottle will be reconstituted with a 100 mL vehicle (0.2% Sodium Dodecyl Sulfate and water) to achieve a suspension for oral administration.
15902069|NCT03633617|Drug|Dupilumab|Solution for injection administered subcutaneously
15902015|NCT03634072|Procedure|PVR|Subjects will undergo PVR via surgery or cardiac catheterization. PVR using cardiac catheterization may require a much shorter hospital stay than traditional heart surgery. If the valve is repaired by surgery, this will require open heart surgery to directly implant a pulmonary valve
15902016|NCT03634059|Drug|Apatinib|apatinib 500mg qd po plus Erlotinib 150mg qd po / apatinib 500mg qd po plus Icotinib 125mg tid po
15902017|NCT03634046|Procedure|Percutaneous transforaminal endoscopic discectomy|The same as the descriptions in experimental group.
15902018|NCT03634046|Procedure|Radiofrequency ablation|The same as the descriptions in active comparator group.
15902019|NCT03634033|Behavioral|MiCAP with IF|Sites will conduct MiCAP strategies described as follows. Relationship Building; Assess readiness to implement of the site; Internal Facilitator (IF) Champion Coalition Building, which will include IFs training in CAPABLE and facilitation and online IF coalition meetings; Facilitation by the IF, which will include training the clinicians, reviewing home visits with the clinician to assure CAPABLE was provided; IF developing a clinical team for implementation of CAPABLE and leading interdisciplinary coordination of individual beneficiary care; Intervention and implementation strategy fidelity data will be placed in a dashboard for audit and provided to IFs. IFs will use the data to provide feedback to clinicians; and develop action plans for improvement in training or care
15902020|NCT03634033|Behavioral|MiCAP with IF and EF|"Sites will conduct MiCAP strategies described above in MiCAP with IF with an addition of External Facilitation. Centralized Oversight will be conducted by External Facilitators. External Facilitators will train in facilitation. The work of the External Facilitators will be tailored (i.e., type of discipline) to each site's needs. Intervention and implementation strategy fidelity data will be placed in a dashboard and will be provided to External Facilitators. External Facilitators will use the data to provide feedback to Internal Facilitators; and develop action plans for improvement in site clinician training or beneficiary care as needed."
15902021|NCT03634020|Device|DynamX Sirolimus-eluting Coronary Bioadaptor System|de novo native coronary artery lesions
15902022|NCT03634007|Biological|LX1001|LX1001 (AAVrh.10hAPOE2) is a serotype rh.10 adeno-associated virus (AAV) gene transfer vector expressing the cDNA coding for human apolipoprotein E2 (APOE2).
15902023|NCT03633994|Drug|Heparin|Heparin is a readily available glycosaminoglycan (GAG) chemically similar to hyaluronic acid and chondroitin sulfate that is currently used to treat chronic painful bladder or interstitial cystitis. Heparin intravesical treatment is an inexpensive second-line treatment for chronic painful bladder, characterized by urinary frequency, urgency and pain. Heparin has been shown to re-establish the bladder urothelial GAG layer and as already noted was shown to reduce recurrent urinary tract infections by 50%.
15902024|NCT03633994|Drug|Normal saline|Normal saline bladder instillation
15902025|NCT03633981|Other|clinical examinations|"Collection of data from the following tests at H0 (as soon as the ECLS is put in place), H12 (within 12 hours following stabilisation of the dynamic state), H24 and every day until complete neurological recovery:
~right and left pupillometry (3 times)
~BIS values
~right and left NIRS values
~right and left transcranial Doppler
~neurological clinical examination"
15902026|NCT03633981|Other|neurological assessment when a neurological event occurs|"next neurological event:
~seizures
~pupillary asymmetry
~myoclonias
~brain stem reflex abnormalities
~osteotendinous reflex abnormalities"
15902027|NCT03633981|Other|mortality assessment|to 28 days
15902028|NCT03633968|Procedure|maxillary sinus lift|maxillary sinus floor elevation by using balloon through either small or large antrostomy without using graft material with simultaneous implant placement
15902029|NCT03633955|Drug|FLT|F18 labeled thymidine PET/CT scans will be performed before and after patient receives therapies.
15902030|NCT03633942|Device|LMA Supreme|Placement of the LMA Supreme supraglottic airway device for patients undergoing outpatient spine surgery in the prone position.
15902031|NCT03633929|Other|KIOS OUD|Study Participants will evaluate software known as KIOS-OUD
15902032|NCT03633916|Behavioral|Classroom sensitization session|"A one-off classroom information and engagement session will be delivered in addition to school-level sensitization activities. Individual classroom sessions will be conducted by a 'lay' counsellor with support from a researcher.
~The classroom session will start with a short animated video which provides age-appropriate information about types, causes, impacts and ways of coping with common mental health problems. The video will be followed by a guided group discussion, structured around a standardized script that builds on the topics covered in the video. In case of technical difficulties that may prevent the video from being shown, a flipchart based on still illustrations from the video will be used.
~At the end of the session, students will be handed a self-referral form which includes normalizing information and question-based prompts to assist with self-identification of mental health problems."
15902033|NCT03633916|Behavioral|School-level sensitization activities|"The control condition intervention will comprise sensitization activities conducted at the whole school level. These activities will include:
~Posters containing information about the school counselling program and referral pathways will be displayed in prominent locations at each school.
~A drop-box for student self-referral slips will be set up in a prominent location at each school.
~Information meetings with teachers and the principal will be conducted at each school from the beginning of the trial."
15902034|NCT03633903|Behavioral|Mindfulness|Mindfulness based stress reduction adapted for teens is a mindfulness intervention designed to aid adolescents in understanding stress, better coping with stress, and promoting resilience
15902035|NCT03633890|Drug|DaZhu Rhodiola Rosea Capsule|Oral administration, 4 capsules, 3 times a day, for 8 weeks
15902036|NCT03633890|Drug|DaZhu Rhodiola Rosea Simulation Capsule|Oral administration, 4 capsules, 3 times a day, for 8 weeks
15902037|NCT03633877|Device|DuraporeTM and Hy-Tape®|Medical tapes
15902038|NCT03633864|Biological|Fecal microbiota transplantation|Fecal donors are selected according to the predefined criteria. Fecal microbiota suspension is prepared by using fresh feces from the selected fecal donors. Then, administration of 200 ml fecal microbiota suspension through a transendoscopic enteral tubing or retention enema.
15902039|NCT03633851|Device|Toric intraocular MX60T lens|one eye will receive toric MX60T lens
15902040|NCT03633851|Other|Standard MX60 plus corneal incisions|the other eye will receive standard MX60 lens with corneal incisions
15902070|NCT03633617|Drug|Placebo|Matching placebo
15902071|NCT03633604|Biological|HBOC-201|Intravenous administration of a hemoglobin based oxygen carrier (HBOC) in patients with life-threatening anemia, for whom allogeneic blood transfusion is not an option.
15902041|NCT03633825|Behavioral|Brief help-seeking barrier reduction intervention|The BRI was designed to overcome common concerns and misconceptions (i.e., barriers) related to using crisis services. It works by first asking the user about what potential barriers may keep them from using the crisis service referrals, and then, based on the user's response, by providing information intended to help the user overcome the potential barrier(s) they selected. By exploring the menu of barriers, users could read brief messages designed to dispel common misconceptions or concerns related to each barrier. For example, a common concern among Koko users was that calls to lifelines invariably result in visits by the police or other emergency services. Users who feared this possibility could tap on the associated button and learn that active rescues such as these are extremely rare, and occur in less than one percent of all cases. Whenever possible, we used language throughout the intervention to help validate the experiences of the users.
15902042|NCT03633812|Other|Observational study, Beta blocker medication history|Observational study, Beta blocker medication history
15902043|NCT03633799|Drug|VeraCept|VeraCept Intrauterine Contraceptive is a hormone free, low dose, copper-releasing birth control method
15902044|NCT03633786|Procedure|standard laparoscopic surgery|removal of endometriotic lesions with laparoscopic instruments (KARL STORZ Gesellschaft mit beschränkter Haftung & Co., Tuttlingen, Germany) using 4 transperitoneal abdominal accesses and trocars from 5 to 12 mm
15902045|NCT03633786|Procedure|robot-assisted surgery|"removal of endometriotic lesions with da Vinci Xi robotic system (Intuitive Surgical Inc., Sunnyvale, CA, USA), using 5 transperitoneal abdominal accesses and trocars from 8 and 12 mm.
~The robotic mechanical arms are associated with the 8 mm abdominal trocars to allow intervention by the first operator, with the aid of a surgical console."
15902046|NCT03633786|Diagnostic Test|assessment of sexual function|assessment of sexual function using a validate questionnaire (Female Sexual Function Index (FSFI)), before and 3 months after surgery
15902047|NCT03633786|Diagnostic Test|assessment of bowel symptoms|assessment of bowel symptoms using a validated questionnaire (Knowles-Eccersley-Scott-Symptom Questionnaire (KESS)), before and 3 months after surgery
15902048|NCT03633786|Diagnostic Test|assessment of urinary symptoms|assessment of urinary symptoms using a validated questionnaire (Bristol Female Lower Urinary Tract Symptoms (BFLUTS)), before and 3 months after surgery
15902049|NCT03633773|Biological|MUC-1 CART cell immunotherapy|After fludarabine and cyclophosphamide pre-chemotherapy，MUC-1 CART immunotherapy is given. A decent interval later, levels of specific antibodies, CART cells and serum cytokines will be assessed.
15902050|NCT03633760|Drug|Bilastine 40mg single dose|Single-dose only cohort treatment duration is 1 day. After the screening period, eligible subjects will be allocated to receive a single dose of 40 mg of bilastine
15902051|NCT03633760|Drug|Bilastine 20mg single-dose followed by multiple-dose|Single-dose followed by multiple-dose cohort treatment duration of this cohort is 9 days. Subjects will receive a single dose of bilastine 20 mg on the morning of Day 1; and six doses of bilastine 20 mg in the morning from Day 4 to Day 9.
15902052|NCT03633747|Drug|Propranolol Hydrochloride|Oral propranolol hydrochloride tablets are administration for 6 months at dose of 1.5 mg/kg or the maximum dose tolerable.
15902053|NCT03633734|Drug|Sequential Treatment|One cycle of the treatment lasts for 56 days. Patients will receive chemotherapy based on Nab-paclitaxel Plus Gemcitabine and modified Folfirinox in sequence order. The cycle will repeat until progression or intolerance of toxicity.
15902054|NCT03633721|Drug|Cannabis|7% delta9-THC cigarettes will be smoked by 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
15902055|NCT03633721|Other|Placebo|0% THC cigarettes will be administered to HIV negative women. Participants will be instructed to 'light the cigarette' (30 sec), 'get ready' (5 sec), 'inhale' (5 sec), 'hold smoke in lungs' (10 sec) and 'exhale.' Participants will smoke 3 puffs in this manner, with a 40-sec interval between each puff.
15902056|NCT03633708|Drug|Etelcalcetide|Etelcalcetide has been shown to be safe and efficacious in treating adult CKD patients with SHPT by simultaneously controlling intact parathyroid hormone (iPTH), Ca, and phosphorus and has recently been approved for use in adult patients with SHPT treated with hemodialysis in both the United States and Europe
15902057|NCT03633695|Device|IC-8 IOL|The AcuFocus IC-8 IOL will be surgically implanted in one eye of each subject. A monofocal or monofocal toric IOL will be surgically implanted in the fellow eye of each subject.
15902058|NCT03633695|Device|Monofocal|A monofocal or monofocal toric IOL will be surgically implanted in both eyes of each subject.
15902059|NCT03633682|Behavioral|Headspace - Meditation and Mindfulness App|Participants randomized to this arm will receive 1-month full access to the Headspace meditation app. They will be asked to listen to at least one meditation a day over the four week study period. Mindfulness is the ability to intentionally and nonjudgementally observe thoughts, bodily sensations, or feelings in the present moment. The apps include guided mindfulness meditations targeting several different areas, such as stress, anxiety, compassion, and sleep.
15902060|NCT03633682|Behavioral|Stop, Breathe, & Think - Meditation and Mindfulness App|Participants randomized to this arm will receive 1-month full access to the Stop, Breathe, & Think meditation app. They will be asked to listen to at least one meditation a day over the four week study period. Mindfulness is the ability to intentionally and nonjudgementally observe thoughts, bodily sensations, or feelings in the present moment. The apps include guided mindfulness meditations targeting several different areas, such as stress, anxiety, compassion, and sleep.
15902061|NCT03633669|Diagnostic Test|Fecal calprotectin|Testing every 3 months
15902062|NCT03633669|Other|Routine care|As per treating gastroenterologist
15902063|NCT03633656|Device|Model predictive control|Computer aided dose selection for the treatment of iron deficient anemia.
15902064|NCT03633656|Device|Model Predictive Control of Iron Dosing|Model Predictive Control of Iron Dosing
15902065|NCT03633643|Drug|oral applications of TMP/SMX 800/160 mg (Nopil forte® tablets)|"five oral applications of TMP/SMX 800/160 mg (Nopil forte® tablets) at the evening of the surgery and thereafter twice daily on day
~1 and 2 after surgery while the patient is in hospital."
15902066|NCT03633643|Drug|oral applications of Placebo|five oral applications of Placebo at the evening of the surgery and thereafter twice daily on day 1 and 2 after surgery while the patient is in hospital.
15902067|NCT03633630|Drug|Amla|Capsules of 500 mg two times per day before breakfast and dinner a total dose of 1000 mg per day. During 90 days
15902075|NCT03633591|Drug|Tolcapone Modified Release Prototype|A single dose of tolcapone modified release prototype (optionally two doses or fed state of prior MR prototype)
15902076|NCT03633578|Behavioral|walk test|"The patient will have to walk on a treadmill in four different conditions:
~without distraction at preferential speed
~with distraction at preferential speed
~without distraction at the speed of 130% of the preferential speed
~with distraction at the speed of 130% of the preferential speed"
15902077|NCT03633565|Drug|Sildenafil (Phosphodiesterase inhibitors)|tablet 25mg
15902078|NCT03633565|Drug|Prednisolone (Steroids)|tablet 20 mg
15902079|NCT03633565|Procedure|Mesenchymal stem cell transplantation|stem cell transplantation intramuscular
15902080|NCT03633552|Drug|Temozolomide|The patients will initially undergo surgery. Within 4 to 6 weeks after surgery, all patients will receive chemoradiation. After completion of chemoradiation, the cases will receive 12 cycles of adjuvant Temozolomide (prescribed as 150 to 200 milligram per square meter body surface per day for the first 5 days of every 28 days). In the control group, the patients will receive 6 cycles of adjuvant Temozolomide (in the same dosage).
15902081|NCT03633539|Procedure|Single-incision Laparoscopic Surgery|Patients undergo single-incision laparoscopic surgery. In this group，the surgery is performed through a transumbilical port. The surgeon will adjust surgical position to expose the operative field with the help of gravity. Besides，hand over hand cross and parallel techniques are needed to achieve the SILS. All the other operative procedures are the same as conventional laparoscopic surgery.
15902082|NCT03633539|Procedure|Conventional Laparoscopic Surgery|Patients undergo conventional laparoscopic surgery. In this group，the surgery is performed through 3-5 ports according to the surgeons habits and specific conditions.
15902083|NCT03633526|Drug|VX-659/TEZ/IVA|VX-659/TEZ/IVA FDC tablet.
15902084|NCT03633526|Drug|IVA|IVA mono tablet.
15902085|NCT03633513|Diagnostic Test|LBT-3627|Immunomodulatory agent
15902086|NCT03633513|Diagnostic Test|Immunological profiling|Comprehensive profiling of inflammatory and anti-inflammatory markers (incl. cellular, molecular) including cellular functional assays
15902087|NCT03633500|Other|Sterile water|Placebo Comparator: Sterile water: 0.2 ml of sterile water is instilled into the posterior buccal cavity in aliquots of 0.1 ml over a 30 second period. The liquid is given time to get absorbed, any pooled liquid is swabbed in the infants' cheek and gum. This is performed every 4 hours until independent safe cup feeds, breastfeed or bottle feed is established consistently for 48 hours.
15902088|NCT03633500|Biological|Breastmilk|Experimental: Breastmilk: 0.2 ml of mothers' own colostrum/ breast milk is instilled into the posterior buccal cavity in aliquots of 0.1 ml over a 30 second period. The colostrum is given time to get absorbed, any pooled milk is swabbed in the infants' cheek and gum. This is performed every 4 hours until independent safe cup feeds, breastfeed or bottle feed is established consistently for 48 hours. independently sucks at breast, bottle or cup feed
15902089|NCT03633487|Drug|Mucinex®|Mucinex® 1200 mg ER Bi-Layer tablet
15902090|NCT03633474|Biological|N. lactamica|Stocks of N. lactamica (strain Y92-1009, sequence type 3493, clonal complex 613) in Frantz medium containing 30% (v/v) glycerol have been previously prepared using the Good Manufacturing Practices pharmaceutical manufacturing facilities at Public Health England (Porton Down, United Kingdom).
15902091|NCT03633474|Other|PBS only|Sterile PBS only containing no bacteria
15902092|NCT03633461|Drug|OC-02|OC-02
15902093|NCT03633461|Drug|Placebo|Placebo
15902094|NCT03633448|Drug|Children's Mucinex® Grape Flavor|1 x 200 mg (10 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate-release formulation
15902095|NCT03633448|Drug|Children's Mucinex® Grape Flavor|1 x 400 mg (20 mL) Children's Mucinex® Grape Flavor 100 mg Guaifenesin/5 mL immediate-release formulation
15902096|NCT03633435|Procedure|assisted home hemodialysis patients|Arteriovenous fistula cannulation at the patient's home provided by a trained private nurse at each dialysis session with the rope-ladder technique, and connection to the Nxstage System One
15902097|NCT03633396|Biological|ANB019|Humanized Monoclonal Antibody
15902098|NCT03633396|Drug|Placebo|Solution
15902099|NCT03633383|Device|Transcatheter aortic valve|Self-expandable aortic valve prothesis
15902100|NCT03633370|Other|Multifaceted intervention including 3 components|Multifaceted intervention including Dispatcher training to improve cardiac phone recognition, mobile application to send bystanders on cardiac arrest location before first professionals rescuers and motivational support for volunteer bystanders
15902101|NCT03633357|Drug|JNJ-18038683|"JNJ-18038683 has been developed by Janssen Pharmaceuticals (Johnson and Johnson), and is a relatively selective high affinity functional 5-HT7 receptor antagonist.
~Participants will take two 10-mg tablets daily, for seven days."
15902102|NCT03633357|Drug|Placebo|Participants will take two placebo tablets daily, for seven days.
15902103|NCT03633344|Drug|Carbowhite|
15902104|NCT03633344|Drug|Carbowhite placebo|
15902105|NCT03633331|Drug|Palbociclib|Given PO
15902106|NCT03633331|Drug|Letrozole|Given PO
15902107|NCT03633331|Drug|Fulvestrant|Given IM
15902108|NCT03633331|Other|Questionnaire Administration|Ancillary studies
15902109|NCT03633331|Other|Quality-of-Life Assessment|Ancillary studies
15902110|NCT03633318|Device|electrical impedance myography (EIM)|EIM is a measure of impedance. EIM is a measure of the obstruction of flow of current through the tissue. It is a completely painless assessment of muscle health.
15902111|NCT03633305|Drug|Hypnotics|Medication used 1 to 7 nights/week for 6 to 8 weeks.
15902112|NCT03633305|Behavioral|Online CBT|Internet self-help program for insomnia with 6 cores.
15902113|NCT03633305|Behavioral|Face-to-face CBT|Face-to-face therapy with 3 to 4 individual sessions in a period of 6 to 8 weeks.
15902114|NCT03633292|Drug|Antiseptic clorhexidine gel (Lacer, Barcelona, Spain)|"Together with the dispensing container, the dosing and dosage of the gel in research will be attached, with the description of the pharmaceutical form, packaging and labeling of the product. Packages with 8 ml of the gel under investigation, sufficient treatment for 1 month of applications. Posology: After tooth brushing, apply a small amount of gel on the fingertip of a freshly washed finger and spread it over the gum, doing a gentle massage, for 15 , 2 times a day after proper oral hygiene and it is recommended not to ingest no liquid or food until after half an hour of use."
15902140|NCT03633084|Drug|RBM-007 Injectable Solution|(No additional description)
15902141|NCT03633071|Other|Web-knee brace|Web -Knee Brace
15902115|NCT03633292|Drug|Master formula of aloe vera gel 80%|Blindly and in the same container as chlorhexidine, patients will be instructed to apply aloe vera gel on the gums and mucous membranes once the orthodontic appliances have been cemented
15902116|NCT03633279|Drug|Branched chain amino acid|Branched chain amino acid 10 grams packet (L-Isoleucine (952 Mg), L-Leucine (1904 Mg.), L-Valine(1144 Mg).
15902117|NCT03633279|Drug|Placebo|an equinitrogenous amount of lactoalbumin 2.1 grams, and equicaloric amount with 4.0 g saccharose and 3.0 g mannitol for a total of 33.6 kcal/packet.(one packet at 6pm and two at 9pm)
15902118|NCT03633266|Procedure|anti-VEGF|vitreoretinal surgery combined with intraoperative anti-VEGF
15902119|NCT03633266|Procedure|PRP|vitreoretinal surgery combined with intraoperative PRP
15902120|NCT03633253|Other|Summarize of participants' characteristics using means and standard deviations or frequencies and percentages|First, prevalence of MCR syndrome will be determined by classifying participants into MCR and non-MCR syndrome groups. Second, between-group comparisons of participants' characteristics will be performed using unpaired t-test, Mann-Whitney, analysis of variance with LSD correction or Chi-square test, as appropriate. Third, multiple regressions will be performed to examine the association between MCR syndrome (dependent variable) and cardio-vascular risk factors and/or diseases (independent variables) adjusted on participants' characteristics. Fourth, the incidence of MCR syndrome during the follow-up period of NuAge study will be reported. Fifth, regression will be performed to examine the association between MCR syndrome (dependent variable) and cognitive decline as well cognitive impairment (independent variables, separated model) adjusted on participants' characteristics.
15902121|NCT03633240|Other|ER assessment|"To measure the effects of recommendations of ER2, the investigators will use ER users who will have an ER2 assessment without any recommendations as the referent group the older. This choice is possible because ER2 will be integrated into ER care in two steps:
~The first step will be limited to its assessment component in order to learn how to use the tool.
~The second step will be to follow the recommendations provided after the assessment.
~Participants will follow-up during their hospitalization via a review of their chart. They will be censored when they will be discharged from the JGH or when the duration of hospitalization will exceed 31 days."
15902122|NCT03633227|Drug|Obeticholic Acid (OCA)|Moderate and Severe hepatic impairment classified as Child-Pugh Class B and C: 5 mg tablet of OCA once weekly titrating up to 5 mg OCA twice weekly based on tolerability at 3 months and subsequently titrating up to a maximum dose of 10 mg OCA twice weekly based on safety and tolerability for the duration of the study.
15902123|NCT03633227|Drug|Placebo|One tablet twice weekly (or a lower frequency based on safety and tolerability) for the duration of the study
15902124|NCT03633214|Other|Online training module|Responses of GPs in the intervention group will then be compared before and immediately after the online training video and also 3-months later; as well as to the control group.
15902125|NCT03633201|Device|Cruciate Retaining|Zimmer Biomet's Personalized Knee system for knee osteoarthritis treatment. The standard insert.
15902126|NCT03633201|Device|Medial Congruent|Zimmer Biomet's Personalized Knee system for knee osteoarthritis treatment. The new anatomical congruent shaped insert.
15902127|NCT03633188|Biological|Patients treated by antibiotherapy|"Biological samples (stool, blood, swabs) will be collected :
~Blood sampling (12 ml) at baseline (week 0) at the end of treatment (W6/W24),and 15 days after antibiotherapy stop (optional) (W8/W26),
~Feces collection at baseline (week 0) during antibiotic treatment (W2), at the end of treatment (W6/W24),15 days after antibiotherapy stop (W8/W26), and W26 after baseline
~Swab samples (nasal and rectal) at baseline at week 0 and at the end of treatment (W6/W24),"
15902128|NCT03633175|Drug|Vaginal progesterone|400 mg vaginal progesterone [Prontogest® vaginal pessaries 400, Marcyrl, Cairo, Egypt] will be given, once at bed time starting from 26-28 weeks of gestation till 36 weeks of gestation or delivery (which is closer).
15902129|NCT03633149|Behavioral|Computer tablet-delivered C4H|Two session CHOICES intervention targeting ineffective contraception and risky alcohol use and/or cigarette smoking and/or marijuana use to reduce the risk of a substance-exposed pregnancy delivered on a computer-tablet.
15902130|NCT03633149|Behavioral|Person-delivered C4H|Two session CHOICES intervention targeting ineffective contraception and risky alcohol use and/or cigarette smoking and/or marijuana use to reduce the risk of a substance-exposed pregnancy delivered by a counselor.
15902131|NCT03633149|Behavioral|Brief Advice|Brief advice delivered by a research associate about healthy behaviors for women including use of contraception and alcohol, tobacco, and marijuana use
15902132|NCT03633136|Behavioral|electronic video education|Solid Organ Transplantation: An Educational Mini-Series for Patients consists of 6 videos ranging in length between 3 and 23 minutes, and has been developed according to best practice for designing education for patients with end-stage renal disease pursuing transplant. Each video outlines a subsequent stage of the transplant process, featuring an animated character embarking on a transplant journey. Animated segments illustrate difficult concepts for patients with poor health literacy, and patient narratives keep the content relevant and culturally inclusive. The educational intervention was developed with experts in medication adherence, video education, motivational psychology, cultural education (First Nations perspective), healthcare providers, and most importantly patients.
15902133|NCT03633123|Drug|D_PLEX|D_PLEX is reconstituted into paste and administered in a single application following closure of the fascia, on the fascia suture line, and on the soft tissues of the abdominal wall along the whole length of the surgical wound (including muscle, fat and dermis).
15902134|NCT03633123|Other|Standard of Care (SoC)|"Prophylactic, pre-operation: 1st or 2nd generation of Cephalosporine family, plus Metronidazole.
~Post-operation: this is each participating center standard practice for this type of procedure"
15902135|NCT03633110|Biological|GEN-009 Adjuvanted Vaccine|GEN-009 Adjuvanted Vaccine consists of GEN-009 Drug Product mixed with Hiltonol (poly-ICLC, adjuvant) and is administered by subcutaneous injection.
15902136|NCT03633110|Drug|Nivolumab|Nivolumab is a PD-1 checkpoint inhibitor approved by the FDA to treat the tumor types in this study.
15902137|NCT03633110|Drug|Pembrolizumab|Pembrolizumab is a PD-1 checkpoint inhibitor approved by the FDA to treat the tumor types in this study.
15902138|NCT03633097|Other|Acupuncture and Usual care|patients after surgery receive usual care(Cnoxane Injection 40mg, Esomezol Capsule, Synerjet Semi Tablet and Ocoron Tablet) as well as acupuncture treatment as an adjunctive therapy
15902139|NCT03633097|Drug|Usual care|patients after surgery receive usual care alone(Cnoxane Injection 40mg, Esomezol Capsule, Synerjet Semi Tablet and Ocoron Tablet)
15902143|NCT03633032|Diagnostic Test|Acquiring of ultrashort echo time (UTE) MRI sequences|Modern MRI sequences (ultrashort echo time (UTE)) for a better depiction of bone anatomy
15902144|NCT03633019|Drug|rhTPO|high dose rhTPO ih
15902145|NCT03633006|Other|Blood Sample Collection|Subjects participating in the study will have blood drawn at enrollment. Additional blood samples may be collected at 12 months from enrollment.
15902146|NCT03633006|Other|Blood Sample Collection|Subjects participating in the study will have blood drawn at enrollment. Additional blood samples may be collected at 12 months from enrollment if lung cancer has not been confirmed.
15902147|NCT03633006|Other|Blood Sample Collection|Subjects participating in the study will have blood drawn at enrollment.
15902148|NCT03632993|Drug|collagenase clostridium histolyticum (CCH)|Endo Pharmaceuticals Inc. (Endo) is developing collagenase clostridium histolyticum (CCH) for the treatment of EFP. Because CCH is a proteinase that can hydrolyze the triple-helical region of collagen under physiological conditions, CCH has the potential to be effective in lysing sub-dermal collagen, such as those observed in the dermal septa, which are the underlying cause of the skin dimpling in women with Edematous Fibrosclerotic Panniculopathy (EFP). CCH targets the collagenase structural matrix (e.g., dermal septa) at the site of injection and does not require systemic exposure to be effective.
15902149|NCT03632980|Device|"Ablatherm Foc/Dyn or Focal One HIFU treatment"|"Non invasive treatment of localized prostate cancer by High Intensity Focused Ultrasound therapy, endorectal application.
~or Non invasive treatment of localized prostate cancer recurrency by High Intensity Focused Ultrasound therapy after radiotherapy failure, endorectal application."
15902150|NCT03632967|Device|Tricinch Coil System Implantation|Patients enrolled in this study with all eligibility criteria confirmed will be implanted with the TriCinch Coil System. This device offers a percutaneous treatment (access through the vein at the groin) to treat the leaking tricuspid valve.
15902151|NCT03632954|Device|ACell Arm|Cytal® Wound Matrix and/or MicroMatrix®
15902154|NCT03632928|Other|Ultrasound Elastography|Measuring muscle hardness at the trapezius and neck bilateral
15902155|NCT03632928|Other|Pressure Pain threshold|Measuring Pressure pain threshold at the trapezius and neck bilateral
15902156|NCT03632915|Drug|Levetiracetam|Standard of care
15902157|NCT03632915|Drug|Lacosamide|Standard of care
15902158|NCT03632915|Drug|Phenytoin|Standard of care
15902159|NCT03632915|Drug|Phenobarbital|Standard of care
15902160|NCT03632915|Drug|Ketamine|Standard of care
15902161|NCT03632915|Drug|Valproic Acid|Standard of care
15902162|NCT03632902|Device|supraglottic device|airway management will be collected
15902163|NCT03632889|Behavioral|GoToSleep Program|For the control group only the sleep hygiene handout will be given in this arm. For the computerized group a sleep hygiene handout along with assess to the GoToSleep online program.
15902164|NCT03632876|Dietary Supplement|retinyl palmitate|The intervention is a daily vitamin A supplement.
15902165|NCT03632863|Behavioral|Electronic Patient Decision Aid|"The electronic PDA is an interactive website with 3 main sections:
~Review of depression treatment options (non-pharmacological and pharmacological) along with their respective risks and benefits.
~Interactive values clarification exercises to help women determine which risks and benefits are most important to them.
~Exercises to help women consider how partners, family, providers and the social context impacts decision-making.
~A summary of how a woman feels about each option along with risks and benefits is generated which can be provided to treating clinicians for use in follow-up.
~A printable pdf with standard published information and resources is also included."
15902166|NCT03632863|Behavioral|Standard Resource Sheet|A control group aims to isolate the PDA's effects from time and clinical care. Controls login to the study website and receive the same printable pdf as in the PDA so that they can access standard publicly available information/resources, even if they will not receive the PDA.
15902167|NCT03632850|Other|web-based interactive tool|an online tool to assist users in decision-making in choice of treatment for advanced cancer
15902168|NCT03632837|Device|Hemoadsorption|see arm description
15902169|NCT03632824|Drug|Tranexamic Acid|"One gram( 2 ampules ) of tranexamic acid was received by the participant intravenously twice daily for 48 hours followed by 500 mg tranexamic acid tablet three times daily for 5 days .
~follow up of the patient was done by recurrence of the bleeding latter on during pregnancy . the course of treatment was repeated again ."
15902170|NCT03632811|Other|A structured interview with every patient|The comprehension test will be done through structured interviews in which the principal investigator will ask if the patient has had difficulty understanding the recommendations and questions, will check the interpretation of all items and the understanding of each word by the patient. In case of problems, the investigator will propose and / or test translation alternatives, or will ask the patient to propose alternatives.
15902173|NCT03632772|Drug|Solifenacin 5Mg|We compared the safety and therapeutic efficacy between Solifenacin and Mirabegron in men with benign prostate hyperplasia and having overactive bladder symptoms immediately after Transurethral Resection of the Prostate.
15902345|NCT03631433|Drug|ibuprofen 600 mg and acetaminophen 650 mg|identical appearing tablets of the combination of ibuprofen and acetaminophen
15902174|NCT03632772|Drug|Mirabegron 50 MG|We compared the safety and therapeutic efficacy between Solifenacin and Mirabegron in men with benign prostate hyperplasia and having overactive bladder symptoms immediately after Transurethral Resection of the Prostate.
15902175|NCT03632759|Drug|Liraglutide|Participants will receive subcutaneous (SC) liraglutide for 8 weeks
15902176|NCT03632759|Drug|Golimumab|Participants will receive subcutaneous (SC) golimumab for 8 weeks
15902177|NCT03632733|Drug|Tetracycline|Tetracycline cream
15902178|NCT03632733|Drug|Clotrimazole|Clotrimazole cream
15902179|NCT03632733|Drug|Tetracycline and Clotrimazole|Combination cream
15902180|NCT03632733|Other|Placebo|Placebo cream without active drug ingredients
15902181|NCT03632720|Biological|Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid conjugate vaccine|Pharmaceutical form: solution for injection; route of administration: intramuscular, 0.5 mL
15902182|NCT03632720|Biological|Meningococcal group B vaccine|Pharmaceutical form: suspension for injection; route of administration: deep intramuscular, 0.5 mL
15902183|NCT03632720|Biological|Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated) vaccine|Pharmaceutical form: powder and suspension for suspension injection; route of administration: deep intramuscular, 0.5 mL
15902184|NCT03632720|Biological|Human rotavirus RIX4414 strain vaccine|Pharmaceutical form: oral suspension; route of administration: oral, 1.5 mL
15902185|NCT03632720|Biological|Pneumococcal 13-valent polysaccharide conjugate vaccine|Pharmaceutical form: suspension for injection; route of administration: intramuscular, 0.5 mL
15902186|NCT03632707|Radiation|Magnetic Resonance Imaging of the knee|After clinical assessment, all the patients will examined by Magnetic Resonance Imaging to diagnose the medial meniscal posterior root tear,and the suspected cases of meniscal extrusion will make MRI using the knee coil for varus stress Overloading simulating weight bearing
15902187|NCT03632707|Procedure|Knee Arthroscopy|Correlate all the magnetic resonance imaging results with the Knee Arthroscopy
15902188|NCT03632694|Behavioral|Health Coaching and Tech Support|"Participants will receive a Jawbone UP2 activity monitor and education materials about the negative consequences of sedentary behavior and suggestions for breaking up sedentary time with light physical activity. Participants receive 5 telephone coaching calls to set up the Jawbone UP2 monitor with their smartphone app and receive tech support help with changing the settings/goals on the app. Additionally, this arm receives health coaching to provide encouragement and further motivate and help study participants to modify their sedentary behavior."
15902189|NCT03632694|Behavioral|Tech Support Only|"Participants will receive a Jawbone UP2 activity monitor and education materials about the negative consequences of sedentary behavior and suggestions for breaking up sedentary time with light physical activity. Participants receive 5 telephone coaching calls to set up the Jawbone UP2 monitor with their smartphone app and receive tech support help with changing the settings/goals on the app. However, there is no additional health coaching."
15902190|NCT03632681|Drug|Intranasal Insulin|Intranasal insulin
15902191|NCT03632681|Drug|Intranasal Placebo|Intranasal placebo manufactured to mimic smell of insulin
15902192|NCT03632668|Drug|AD-2071 10/20mg|AD-2071 10/20 mg tablet
15902193|NCT03632668|Drug|AD-2072 80/5mg|AD-2072 80/5mg tablet
15902194|NCT03632668|Drug|AD-2071 10/20mg + AD2072 80/5mg|AD-2071 10/20 mg + AD-2072 80/5mg tablet
15902195|NCT03632655|Procedure|prostate biopsy|Men will be randomized to receiving either TPM or TRUS targeted biopsy
15902196|NCT03632642|Drug|Benzylpenicillin|The study drug will be administered for a minimum of 2 weeks (the minimal currently accepted duration of IV therapy for SAB.) For patients who do not fulfill criteria for 2 weeks of therapy, the duration of treatment will be 4 to 6 weeks and will be made by the treating clinician.
15902197|NCT03632642|Drug|Flucloxacillin|The study drug will be administered for a minimum of 2 weeks (the minimal currently accepted duration of IV therapy for SAB.) For patients who do not fulfill criteria for 2 weeks of therapy, the duration of treatment will be 4 to 6 weeks and will be made by the treating clinician.
15902198|NCT03632629|Other|interactive cognitive training|Using interactive brain club system training to children with attention deficit hyperactivity disorder with developmental delay
15902199|NCT03632616|Other|PANQOLI (quality of life instrument)|A quality of life instrument, the PANQOLI, will be administered prior to endoscopic intervention, and at 1,3, and 6 months post-intervention.
15902200|NCT03632603|Radiation|No intervention|No intervention during study period.
15902201|NCT03632590|Dietary Supplement|Magnesium Citrate|450 mg of Magnesium Citrate per day (6 capsules per day) for 24 weeks
15902202|NCT03632590|Dietary Supplement|Magnesium Sulfate|450 mg of Magnesium Sulfate per day (6 capsules per day) for 24 weeks
15902203|NCT03632590|Dietary Supplement|Magnesium Oxide|450 mg of Magnesium Oxide per day (6 capsules per day) for 24 weeks
15902204|NCT03632590|Drug|Placebo|The placebo capsules will contain starch (Amylum solani) for 24 weeks
15902205|NCT03632577|Device|High Flow Oxygen (HFO)|HFO is a mix tap of air and oxygen. It permits to control FiO2 and generated controlled high flow air until 60/min. Air and oxygen are mixed, warmed, humidified and issued to patient by a warming monopod inspiratory circuit to nasal cannulas of a large diameter. Expiration is free.
15902206|NCT03632577|Device|Non Invasive Ventilation (NIV)|NIV was already evaluated in post-extubation. This technic is now used in daily consolidation processing after extubation because it provides a ventilator help with two levels of pressure helping in respiratory work. Adding Automated Flow Oxygen Titration could optimized patient's oxygenation and reduce workload of caregivers.
15902207|NCT03632564|Device|REVIVIEW dichoptic audio-visual stimulation|REVIVIEW dichoptic audio-visual stimulation using video goggles
15902208|NCT03632551|Other|Specific binaural hearing evaluations|Specific binaural hearing evaluations (recognition of sentences in noise, sound source localization) and quality of life (SSQ questionnaire) will be carried out. Thereafter, the electroencephalographic examination will be performed
15902209|NCT03632538|Diagnostic Test|"Biomarker (penKid, adrenomedulin, C-terminal alpha-1 antitrypsin peptide)"|Drawing of patients blood for measurement of biomarkers for AKI before and after cardiac surgery (times: 0, 6, 24, 72, 168 hours).
15902210|NCT03632525|Drug|Ferric carboxymaltose|Single dose of 20 mg/kg ferric carboxymaltose (maximum 1000 mg for patients with haemoglobin <14 g/dL or 500 mg for patients with haemoglobin ≥14 g/dL).
15902211|NCT03632512|Dietary Supplement|Hericium honey bolus|The subjects of the experimental group will be supplemented with Hericium Erinaceus honey bolus(430 mg/kg/day) for eight months.
15902212|NCT03632512|Dietary Supplement|Placebo honey bolus|The subjects of the control group will be supplemented with Placebo honey bolus(8 bolus/ day) for 8 months.
15902213|NCT03632499|Other|rehabilitation|rehabilitation
15902214|NCT03632486|Other|Bedside Ultrasound|"Patients enrolled in this study will undergo bedside ultrasound during their initial presentation to the emergency department. Ultrasound imaging protocols include the following:
~FAST Exam - Standard images will be obtained using the abdominal transducer. Images include the following: 1) sub-xyphoid 2)right upper quadrant (with right thorax) 3)left upper quadrant (with left thorax) and 4) suprapubic
~Right Upper Quadrant Exam - Standard images will be obtained using the abdominal transducer. Images include the following: 1) Long axis of the gallbladder 2) Transverse axis of the gallbladder fundus 3) Transverse axis of the gallbladder body and 4) Transverse axis of the gallbladder neck.
~Lung ultrasound to assess for pleural effusions and sonographic b lines."
15902215|NCT03632473|Diagnostic Test|multimodal evoked potentials (mmEP)|combination of visual evoked potentials (VEP) and motor evoked potentials (MEP) or the combination of VEP, MEP and somato-sensory evoked potentials (SSEP)
15902216|NCT03632460|Drug|Dexmedetomidine Injection [Precedex]|epidural administration of dexmedetomidine added to ropivacaine
15902217|NCT03632447|Device|Leva|Subjects randomized to Leva will use a vaginal probe containing motion-based sensors to direct the performance of pelvic muscle exercises.
15902218|NCT03632447|Device|PFDx|All subjects (in both study arms) will be evaluated using a vaginally placed device that will evaluate pelvic floor motion to document change in pelvic floor muscle function resulting from pelvic floor muscle exercises.
15902219|NCT03632434|Device|transcranial direct current stimulation|tDCS generates a small electric current which modulates how easy it is for active brain cells to discharge. The device is a neoprene cap worn over the head, and in the cap there are two electrodes, which are small metal discs, where the current comes from.
15902220|NCT03632421|Other|ENDS (vaporizer/e-cig) and smoking cessation counseling|Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit.
15902221|NCT03632421|Other|Smoking cessation counseling|Participants in the control group will receive smoking cessation counseling only. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit.
15902222|NCT03632408|Drug|Zopiclone|Oral, single dose, 7.5 mg
15902223|NCT03632408|Behavioral|hangover|as per subjects choice to consume alcohol
15902224|NCT03632408|Drug|Placebo oral capsule|oral
15902225|NCT03632395|Diagnostic Test|computed tomography|computed tomography
15902226|NCT03632382|Diagnostic Test|3D acquisition of maxillofacial characteristics|A 3D acquisition of maxillofacial characteristics will be performed for each patient in order to validate a predictive model comparable to data obtained by polysomnography
15902227|NCT03632369|Diagnostic Test|Hyperpolarized xenon-129 MRI|Participants will be asked to inhale the xenon-129 contrast agent according to procedure for gas administration. The success criterion of the drug is a obtained Xe MRI lung image with reasonable signal level. The clinical MRI scanner Philips Achieva 3.0T will be equipped with 129Xe Quadrature Transreceive Lung Coil (Large and Small) to acquire 129Xe lung images. The resonator length of the large coils is equal to 122 cm, whereas the same size of the small coil is equal to 106 cm. The success criterion of the device performance is the obtained reasonable Xe MRI lung image.
15902228|NCT03632356|Behavioral|Stepped Care Intervention (STEP)|A stepwise progression of intervention according to the participant's response to the increasing levels of therapy. There will be 1 session of psychoeducation, followed by 5 sessions of Cognitive Behavioral Therapy (CBT) if panic symptoms do not improve at 1-month follow-up.
15902229|NCT03632356|Diagnostic Test|Screening only|Screening for probable panic attacks or panic disorder using the Structured Clinical Interview for DSM-5
15902230|NCT03632343|Other|Pain Squad+ with Nurse Support|Pain Squad+ smartphone app with algorithm-driven pain management advice registered nurse (RN)-initiated pain support. Email alerts related to clinically important incoming pain reports (3 consecutive reports of pain >3/10) will be sent to the study RN who will contact the healthcare team at the participants' home center to initiate clinician-driven intervention, which may be outside of the scope of the self-management algorithm. The RN will contact the participant within 12 hours of receiving the alert, including on weekends.
15902231|NCT03632343|Other|Pain Squad+|Pain Squad+ smartphone app with algorithm-driven pain management advice without RN-initiated pain support.
15902232|NCT03632330|Drug|Dexmedetomidine|Dexmedetomidine group
15902233|NCT03632330|Drug|Midazolam|Midazolam group
15902234|NCT03632330|Drug|Propofol|Propofol group
15902235|NCT03632330|Drug|Midazolam/Propofol|Midazolam/Propofol group
15902236|NCT03632317|Drug|Panobinostat|30 mg/m^2
15902237|NCT03632317|Drug|Everolimus|3.0 mg/m^2
15902238|NCT03632304|Procedure|Local anesthesia with minimal sedation|The operating surgeon will perform a digital or wrist block to numb the surgical area prior to the surgery, instead of using a brachial plexus block.
15902239|NCT03632291|Biological|UB-221|UB-221 (75 mg/ml)
15902240|NCT03632278|Behavioral|Mindfulness psychoeducation Programme|"A MBPP will be conducted for 2 hours for each session, one a week for eight weeks. The protocol has been developed based on the model of mindfulness-based stress reduction proposed by Kabat-Zinn (1994) and Tong et al. (2015), and the psychoeducation programmes by Chien and Lee, and Lehman and colleagues (Chien & Lee, 2010; Kabat-Zinn et al., 1992; Lehman et al., 2004; Tong et al., 2015).
~The programme will be integration of mindfulness and psychoeducation to cultivate the client's mindfulness attitude. The clients will learn to apply the mindfulness in illness management and daily difficulties."
15902242|NCT03632226|Drug|18F-OGA-1|
15902243|NCT03632213|Drug|Losartan|Losartan group: 15 patients, both sexes, will receive Losartan 0.4 to 1.4 mg/kg/day orally for 12 months.
15902244|NCT03632213|Drug|Placebo|Placebo group: 15 patients, both sexes, will receive oral placebo for 12 months.
15902245|NCT03632200|Other|Experimental group|"The patients with a cancer of the VADS: in preoperative, all the patients will benefit from dietary advice during a multidisciplinary specific consultation (physiotherapist, dietician, nursing staff CMF). The accent will be put on the adaptations of the diet, the complementary nutritional contributions, the assistants in better to eat.
~In post-operative, a dietetic consultation will be set up in 7 days at the post hospitalization and rate call phone at M1, M2, M4 and M5.
~The undernourished patient will benefit besides a multidisciplinary consultation at the rate of a consultation a month during 6 months according to the same conditions"
15902246|NCT03632187|Drug|Abatacept|Subcutaneous abatacept every weeks during 3 months
15902247|NCT03632187|Drug|Placebos|Subcutaneous placebo every week during 3 months
15902248|NCT03632174|Other|Topical Ointment with L. reuteri|Topical Ointment containing live Lactobacillus reuteri DSM17938 applied twice daily in dry areas of the entire body
15902249|NCT03632174|Other|Topical Ointment without L. reuteri|Topical Ointment that does not contain Lactobacillus reuteri DSM17938 applied twice daily in dry areas of the entire body
15902250|NCT03632161|Drug|Dexmedetomidine|isobaric bupivacaine 0.5% (0.3ml/kg) and dexmedetomidine (1 mcg/kg)
15902251|NCT03632161|Drug|Bupivacaine|isobaric bupivacaine 0.5% (0.3ml/kg)
15902254|NCT03632109|Drug|gentamicin 360mg IM|360mg IM of gentamicin
15902255|NCT03632096|Radiation|Photobiomodulation|The parameters are: Laser Diode ArGaAl, DMC, 808nm, 4J per point, continuously and in contact with the irradiated surface, resulting in irradiance of 3571 mW/cm2, distributed as follows: 6 points in each parotid, 2 points in each sublingual (external) and two in each submandibular (internal), totaling 16 extra oral and 4 intra oral, totaling 20 points. The exposure time will be 40s per point, corresponding to 800s per session and 3600s at the end of the four treatment sessions. The radiant exposure will be 142J/cm2.
15902256|NCT03632096|Radiation|Sham|The sham group will have a simulation of laser application, following the same procedures as the active group, but with the device switched off.
15902257|NCT03632083|Device|Hy-Care Contact Lens Solution|Hy-Care Contact Lens Solution
15902258|NCT03632083|Device|Lite Contact Lens Solution|Lite Contact Lens Solution
15902259|NCT03632083|Device|fanfilcon A soft contact lens|fanfilcon A soft contact lens
15902260|NCT03632083|Device|comfilcon A soft contact lens|comfilcon A soft contact lens
15902261|NCT03632070|Behavioral|Data acquisition of functional abilities|MRI data, motor evoked potentials, and behavior data acquisition
15902262|NCT03632057|Device|Fixed Tilt (65%)|This is the standard group, so device programming for shock energy is the default setting
15902263|NCT03632057|Device|Fixed Pulse Width|The device has to be programmed with fixed pulse width for each phase of the biphasic waveform
15902264|NCT03632044|Drug|Ropivacaine|A single injection into the pterygopalatine fossa bilaterally of 0.2% ropivacaine at a dose of 0.15 mL/kg (block) after the induction of general anesthesia
15902265|NCT03632044|Other|Sham Comparator|The subcutaneous placement of a 25 Gauge needle as a sham control after the induction of general anesthesia. Nothing will be injected.
15902266|NCT03632031|Device|Oasis Extracellular Matrix|Patients will receive OASIS Extracellular Matrix according to the Instruction for Use
15902267|NCT03632018|Behavioral|HEART-PLAY|Participants assigned to the HEART-PLAY intervention will receive standard CR. Additionally, they will receive pedometers, group education, and educational materials introduced by peer Health Coaches for 12 months. Before or after their regularly scheduled CR appointments, they will meet at the clinic as a group twice per week to receive Health Tips and participate in discussions. At 8 weeks in to the 12-week CR, they will begin to discuss with their peer Health Coaches the transition from the formal CR setting into community-based exercise. As part of this transition, peer Health Coaches will slowly introduce group community walks and train participants in the proper use of resistance bands. Health Coaches will have talk with their assigned participants about relapse prevention and sustaining exercise following the termination of formal CR.
15902268|NCT03632018|Behavioral|Standard Cardiac Rehabilitation|During the 12-week intervention period, the STANDARD intervention participants will receive standard of care by attending the 36 sessions of standard CR as prescribed by his/her physician and administered by the Step Clinic.
15902269|NCT03632005|Device|Vacuum Assisted Closure|Patients will be randomized to receive either standard dressing changes or the Prevena™ System on the day of their operation.
15902270|NCT03632005|Other|Sterile dressing|Standard wound care involves the application of an occlusive dressing in the operating room, a dressing change on Post-operative Day 3 and then dressing changes as needed until suture/staple removal on Post-operative Day 14.
15902271|NCT03631992|Behavioral|Low Sweet|Children in the experimental group get repeated exposure to lower sweet snacks and mothers get education lessons on dental care, reading food labels, portion size, and nutrition.
15902272|NCT03631992|Behavioral|Regular Sweet|Children in sham comparator get typical snacks and mothers get education lessons on portion size, physical activity, sleep, and screen time.
15902346|NCT03631420|Biological|Human Umbilical Cord Derived-Mesenchymal Stem Cells|Cohort 1 : 3 million cells/kg ; Cohort 2 : 10 million cells/kg ; Cohort 3 : 30 million cells/kg
15902273|NCT03631979|Other|Intestinal lavage with normal saline|Specially trained pediatric surgeon will administer 10ml/kg pre-warmed (37oC) normal saline via a single-use rectal tube of size 6FR twice per day, aiming at a depth of maximum 10 cm/kg, starting after randomization and not later than 24 hours of age, and continued until full enteral nutrition of 170ml/kg/day is achieved or NEC diagnosis (Bell stage II or more) is established, which one comes first. However, the intervention will be applied at a maximum of 2 weeks from birth.
15902274|NCT03631966|Drug|Dysport|BTX-A (Dysport-Ipsen Inc.) will be injected into the proximal third of the medial and lateral gastrocnemius muscles of the symptomatic leg(s). Total dose per leg will be 400 units, 200 per injection site. Injections will be performed with the aid of real-time ultrasound (Sonosite, Bothwell, WA) guidance.
15902275|NCT03631953|Drug|Trametinib|Trametinib administered at a fixed dose (1.5 mg daily)
15902276|NCT03631953|Drug|Alpelisib|A panel of 3 doses of ALPELISIB could be tested
15902277|NCT03631953|Biological|Blood sample|Therapeutic biomarkers
15902278|NCT03631953|Device|MRI|A MRI with contrast will be performed before treatment start. Assessment of tumor growth.
15902279|NCT03631940|Procedure|Umbilical Cord Milking|At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 15-20 seconds.
15902280|NCT03631940|Procedure|Early Cord Clamping|The umbilical cord is clamped within 30 seconds of delivery.
15902281|NCT03631914|Procedure|Infraclavicular brachial plexus block|An infraclavicular brachial plexus block is performed using ultrasound guidance.
15902282|NCT03631901|Drug|oral melatonin|Both melatonin and diazepam were given only during the febrile illness.
15902283|NCT03631901|Drug|oral diazepam|Both melatonin and diazepam were given only during the febrile illness.
15902284|NCT03631888|Diagnostic Test|preoperative abdominal ultrasound examination|Performing preoperative abdominal ultrasound examination in patients that will be scheduled for elective laparoscopic surgery for any gynecologic indication
15902285|NCT03631875|Drug|Ketamine|use a low dose 0.5 mg/kg of ketamine in coinduction with propofol in children induction anesthesia
15902286|NCT03631862|Drug|Apatinib|Apatinib is an orally administrated small molecule receptor tyrosine kinase inhibitor selectively targeting VEGFR-2, showing anti-tumor activity across a broad range of advanced cancers.
15902287|NCT03631862|Drug|CHOP Regimen|CHOP regimen(Cyclophosphamide,Vindesine,Epirubicin,Prednisone)
15902288|NCT03631849|Procedure|peri implantitis sanitation surgery|"an intrasulcular vestibular and lingual / palatal incision with respect to the implant-supported restoration involved is performed, it extends to at least one tooth on either side in order to give laxity to the flap. The use of an incision of discharge will be necessary if the muco-periosteal detachment of the flap (that is to say of full thickness) is considered insufficient to access and unclamp the peri-implant lesion.
~Then, the debridement will be carried out using manual curettes in titanium: the products (waste) removed with this curette will constitute the peri-implant pocket specimens. This sample will be deposited in a Roswell Park Memorial Institute Medium (RPMI) supplemented with serum.The surface of the titanium implant will then be disinfected with betadine, or with hydrogen peroxide for patients with an allergy to polyvidone iodine.
~The flap will then be repositioned and sutured with simple stitches made with a resorbable suture of Vicryl type 5.0."
15902289|NCT03631849|Other|Care|descaling and maintenance of implants
15902290|NCT03631836|Drug|Monoclonal antibody|3 doses of Monoclonal antibody could be tested
15902291|NCT03631836|Drug|Bevacizumab|fixed dose of bevacizumab (10 mg/ kg every two weeks)
15902292|NCT03631836|Biological|Blood sample|Evaluate the biomarkers plasma levels during administration of drug
15902293|NCT03631836|Device|Dynamic Contrast Enhanced magnetic resonance imaging (DCE-MRI)|Assess antiangiogenic effects by DCE-MRI
15902294|NCT03631823|Other|Chemotherapy with temozolomide or no chemotherapy|This study is just an observational study.
15902295|NCT03631797|Procedure|Microvascular reactivity evaluation|Microcirculation will be evaluated for each patient before surgery with a laser speckle contrast imaging (LSCI) placed on the forearm. Tests will be performed for evaluation of endothelium reactivity: Iontophoresis.
15902296|NCT03631784|Drug|Pembrolizumab 200 mg|Pembrolizumab 200 mg intravenous (IV) infusion on Days 1 of each 3-week cycle for up to 17 cycles
15902297|NCT03631784|Drug|Paclitaxel 45 mg/m^2|Paclitaxel 45 mg/m^2 IV infusion on Days 1, 8, 15 of each 3-week cycle for Cycles 2, and 3 during radiation therapy.
15902298|NCT03631784|Drug|Carboplatin AUC6|Carboplatin AUC6 IV infusion on Day 1 of the 21-day cycle for Cycle 1.
15902299|NCT03631784|Drug|Cisplatin 75 mg/m^2|Cisplatin 75 mg/m^2 IV infusion on Day 1 of each 21-day cycle for Cycles 1, 2, 3.
15902300|NCT03631784|Drug|Pemetrexed 500 mg/m^2|Pemetrexed 500 mg/m^2 IV infusion on Day 1 of each 21-day cycle for Cycles 1, 2, and 3.
15902301|NCT03631784|Radiation|Thoracic Radiation Therapy (TRT)|The target total dose of TRT will be 60 Gy in 30 daily fractions of 2 Gy, prescribed to the planning target volume.
15902302|NCT03631784|Drug|Paclitaxel 200 mg/m^2|Paclitaxel 200 mg/m^2 IV infusion on Day 1 of the 21-day cycle of Cycle 1.
15902303|NCT03631784|Drug|Carboplatin AUC2|Carboplatin AUC2 IV infusion on Day 1, 8, 15 for Cycles 2 and 3 during radiation therapy.
15902304|NCT03631771|Drug|Iohexol|Iohexol administered intravascularly
15902305|NCT03631771|Drug|Iodixanol|Iodixanol administered intravascularly
15902306|NCT03631771|Drug|Iopromide|Iopromide administered intravascularly
15902307|NCT03631771|Drug|Ioversol|Ioversol administered intravascularly
15902308|NCT03631758|Other|Evidence-based information|Evidence-based information on mammography such as blog posts, plain language evidence summaries and web resource ratings (quality-appraised online resources).
15902309|NCT03631758|Behavioral|Patient Decision Aid|Patient Decision Aid for breast cancer screening decision
15902310|NCT03631758|Other|Sham information|Educational information not specific to mammography or cancer screening
15902311|NCT03631745|Behavioral|NAMI Mental Health 101 and NAMI FaithNet|"Congregants of Intervention Churches will receive:
~NAMI Mental Health 101, a 60-90 minute, contact-based educational intervention
~NAMI FaithNet which consists of congregational support and training to cultivate supportive environments within faith communities for those with mental health conditions and their families."
15902312|NCT03631732|Drug|B/F/TAF|50/200/25 mg FDC tablets administered orally once daily without regard to food
15902313|NCT03631732|Drug|NRTIs|"The following NRTIs will be administered as prescribed until Week 24 without regard to food:
~abacavir (ABC), emtricitabine (FTC), lamivudine (3TC), tenofovir alafenamide (TAF), tenofovir disoproxil fumarate (TDF), zidovudine (ZDV or AZT)"
15902314|NCT03631732|Drug|Third Agent|"Any one of the following third agents will be administered as prescribed. Protease inhibitors and EVG will be administered with the appropriate pharmacologic booster cobicistat or ritonavir. :
~Non-nucleoside reverse transcriptase inhibitors (NNRTIs)
~delavirdine (DLV)
~efavirenz (EFV)
~nevirapine (NVP)
~rilpivirine (RPV)
~doravirine (DOR)
~Integrase inhibitors
~dolutegravir (DTG)
~elvitegravir (EVG)
~raltegravir (RAL)
~Protease inhibitors (PIs)
~atazanavir (ATV)
~darunavir (DRV)
~lopinavir (LPV)
~nelfinavir NFV)
~saquinavir (SQV)
~tipranavir (TPV)
~Chemokine co-recptor 5 (CCR5) antagonist --maraviroc (MVC)"
15902315|NCT03631719|Biological|Wolbachia-carrying Ae.aegypti mosquitoes|Wolbachia-infected Ae. aegypti mosquito eggs and adults sequentially deployed into Medellin and Bello, Colombia. Deployments cease once Wolbachia prevalence has reached a predetermined frequency (usually ≥60%).
15902316|NCT03631706|Drug|M7824|Participants will receive an intravenous infusion of 1200 milligrams (mg) M7824 once every 2 weeks starting from Day 1 up to disease progression.
15902317|NCT03631706|Drug|Pembrolizumab|Participants will receive an intravenous infusion of 200 mg Pembrolizumab once every 3 weeks starting from Day 1 up to disease progression.
15902318|NCT03631693|Procedure|Simplified papilla preservation flap|The simplified papilla preservation flap (SPPF) surgery is a conservative surgical procedure aimed at the preservation of the tissues between the teeth providing access for the debridement of the root surface in sites with residual pockets.
15902319|NCT03631693|Procedure|Resective periodontal flap with osseous recontouring|The Resective periodontal flap with osseous recontouring (RPFO) is a surgical procedure that achieves predictable pocket depth reduction by soft and hard tissue resection to obtain a more convenient soft and hard tissue architecture for oral hygiene.
15902320|NCT03631680|Procedure|Bilateral Oophorectomy Surgery|Women undergoing elective, laparoscopic bilateral oophorectomy surgery will be enrolled.
15902321|NCT03631667|Drug|[14C]-benzo[a]pyrene|Oral micro-dose (50 ng) (5.4 nCi)
15902322|NCT03631667|Drug|[14C]-benzo[a]pyrene plus phenanthrene|Oral micro-dose of 50 ng (5.4 nCi) [14C]-benzo[a]pyrene plus 1250 ng phenanthrene
15902325|NCT03631641|Biological|Nivolumab|Given IV
15902326|NCT03631628|Device|Transcutaneous electrical nerve stimulation (TENS)|TENS will be delivered to the median and radial nerves at the wrist regions. The stimulation frequency will be 100Hz and with an intensity just below the motor threshold.
15902327|NCT03631628|Behavioral|Mirror Therapy (MT)|"A customised angle-adjustable frame with a mirror board will be used. All subjects are instructed to perform
~Wrist flexion and extension exercise
~Forearm pronation and supination exercise
~Gripping exercises
~Fingers opposition exercises bilaterally during the 30 minutes period."
15902328|NCT03631628|Behavioral|sham-Mirror Therapy (sham-MT)|"A customised angle-adjustable frame with a mirror board will be used while the reflecting surface of the mirror was covered with paper. All subjects are instructed to perform
~Wrist flexion and extension exercise
~Forearm pronation and supination exercise
~Gripping exercises
~Fingers opposition exercises bilaterally during the 30 minutes period."
15902329|NCT03631628|Behavioral|Conventional Rehabilitation Program|All subjects attended 1 hour multi-disciplinary conventional rehabilitation program offered by the Rehabilitation Clinic of The Hong Kong Polytechnic University. The conventional rehabilitation program involves the training of upper and lower limbs in order to improve the muscle strength, balance and functional mobility.
15902330|NCT03631615|Drug|Neoadjuvant chemoradiation plus PD-1 antibody(SHR-1210)|"Patients will be given the perioperative treatment as below once recruited:
~induction Neochemotherapy (3w): one cycle of XELOX regimen before surgery;
~within one week after the induction, concurrent neochemoradiation will be started (5w): intensity modulated radiotherapy was given for tumors and high-risk lymphatic drainage areas.
~consolidation neochemotherapy will be started in 2-3w after concurrent chemoradiation: one cycle of XELOX regimen; From the beginning of induction chemo to 3w before surgery, PD-1 antibody SHR-1210 will be given q3W.
~Re-evaluation will be conducted in 1-3w after consolidation chemo, resectable patients will receive D2 resection.
~Adjuvant chemo: We advise starting 4 cycles of XELOX regimen in 4-6w after surgery."
15902331|NCT03631602|Drug|antifungal prophylaxis|posaconazole oral suspension vs itraconazole oral solution
15902332|NCT03631589|Biological|MSCs|mesenchymal stem cells therapy
15902333|NCT03631576|Biological|CD123/CLL1 CAR-T Cells|CD123/CLL1 CAR-T Cell Therapy
15902334|NCT03631563|Drug|Immunosuppressive Agent|ATG-Fresenius versus ATG
15902335|NCT03631550|Device|Relivion active|1 hour self-administered occipital and supraorbital transcutaneous nerve stimulation
15902336|NCT03631550|Device|Relivion Sham|1 hour self-administered Sham occipital and supraorbital transcutaneous nerve stimulation
15902337|NCT03631537|Other|NST group|Nutrition-support-team based intervention on nutrition, including dietary supplement, parenteral nutrient solutions and patient education
15902338|NCT03631524|Device|Telerehabilitation|The treatment arm will be given up to 1 hour of physiotherapist-prescribed resistive training exercises administered via a telerehabilitation device per day in addition to standard therapy for a total of 10 sessions over a 2 week period.
15902339|NCT03631511|Procedure|direct pulp capping with RetroMTA|The study included seven caries-free third molars from three adults. These teeth were subjected to pulp exposure, direct capping with RetroMTA, and restoration with a composite resin. Seven months later, the teeth were clinically and radiographically evaluated. The teeth were then extracted and subjected to histological processing and evaluation.
15902340|NCT03631485|Other|Exposure_having children with cancer|No intervention. The exposure is having children with cancer.
15902341|NCT03631472|Device|RheOx|RheOx is a device-based, energy delivery system that delivers energy to ablate soft tissue such as the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope.
15902342|NCT03631459|Drug|Kanglaite Injection/Capsules|Kanglaite injection 200 mL, iv. gtt qd×7d or more, followed by Kanglaite capsule 0.45g×6 tablets qid po×14d as one cycle for at least 4 cycles
15902348|NCT03631407|Biological|Pembrolizumab|Pembrolizumab administered by IV infusion at 200 mg Q3W, given on cycle day 1.
15902349|NCT03631394|Other|beetroot and anthocyanin|Beetroot and anthocyanin will be taken for 7 days during the study two hours prior to eating.
15902350|NCT03631394|Other|beetroot and placebo|Beetroot and placebo will be taken for 7 days during the study two hours prior to eating.
15902351|NCT03631368|Drug|Botox|Intradermal injection with Botox 100U/mL will be performed using a 25g needle. Each subject will receive three treatments spaced 1 month apart.
15902352|NCT03631355|Drug|Tranexamic Acid|One gram of intravenous tranexamic acid will be administered before tourniquet inflation and 1 gram of IV TXA before closure of the incision.
15902353|NCT03631342|Other|VCV20|controlled volume ventilation mode under constant flow of 20 Lpm. The inspired volume was progressively increased until the Pmax reached 40cmH2O.
15902354|NCT03631342|Other|VCV40|volume controlled ventilation mode under constant flow of 40 Lpm. The inspired volume was progressively increased until the Pmax reached 40cmH2O.
15902355|NCT03631342|Other|PCV|controlled ventilation mode, 1 second inspiratory time. The inspiratory pressure was increased every 5 cmH2O, until reaching the maximum pressure of 40 cmH2O.
15902356|NCT03631342|Other|PCV+Tins|controlled ventilation and inspiratory pressure was increased every 5 cmH2O until the maximum pressure was 40 cmH2O. The inspiratory time was gradually increased until the inspiratory flow reached the baseline. Concomitantly, the respiratory rate was decreased to allow the expiratory flow also to reach the baseline, to avoid self-PEEP.
15902357|NCT03631342|Other|PSV|ventilatory mode with pressure support, with progressive increases of 5 cmH2O at inspiratory pressure, until reaching Pmax of 40 cmH2O. The expiratory sensitivity was adjusted by 25% for all patients.
15902358|NCT03631329|Diagnostic Test|Doppler sonographic measurement|First, place a 4.5-12.0 MHz linear array transducer vertically on the neck with the probe marker facing the patient's head. A long axis B-mode image of the right common carotid artery is obtained at the lower border of the thyroid cartilage. The sample volume is then placed in the center of the lumen located approximately 2 cm proximal to the carotid bifurcation. Next, pulsed wave Doppler tracing is performed in the arterial blood flow. The cycle time using the calliper function in an ultrasonic machine is obtained by measuring the interval between heartbeats at the beginning of the Doppler blood flow upstroke and the Flow time is measured as the time from the beginning of the systolic upstroke to the dicrotic notch.
15902359|NCT03631316|Drug|Generic Valganciclovir|900 mg daily during 4 days
15902360|NCT03631316|Drug|Innovative Valganciclovir|900 mg daily during 4 days
15902361|NCT03631303|Device|Cardiac stimulation through the device leads|During scheduled device replacement extra-systolic beats with various extrasystolic and post-extrasystolic coupling intervals will be evoked by electrical stimulation via the right atrial and ventricular device leads of the patient. Throughout the stimulation study blood pressure will be measured non-invasively using a finger arterial blood pressure photoplethysmographic device and a continuous electrocardiogram will be recorded.
15902362|NCT03631290|Behavioral|Deprescribing Intervention|Participants who are taking specific potentially inappropriate medications and their nephrologist will be engaged in the deprescribing process. The process involves deprescribing decision-making, implementation of deprescribing, and monitoring for adverse drug withdrawal events. The specific details of the deprescribing process are TBD.
15902363|NCT03631277|Device|photo-activated oral disinfection|Application of PAD solution using disposable tip with agitation of the solution for 60 seconds using a brush; Placement of the light disposable tip in center of lesion and holding it just above the surface; Activation of the red light for 60 seconds; (h)Sealing the cavity with glass ionomer and then filling with composite resin as a final restoration
15902364|NCT03631277|Drug|Calcium Hydroxide|calcium hydroxide( Dycal ® Dentsply Caulk )was applied using calcium hydroxide applicator followed by glass ionomer and then composite resin as a final restoration
15902365|NCT03631264|Device|Kinesiotape|Kinesiotape application to masseter and hyoid muscles of late preterm infants to improve sucking and swallowing.
15902366|NCT03631251|Drug|Open Placebo|Open placebo in addition to the standard course of opioids. Opioids are given consistent with standard care.
15902367|NCT03631238|Diagnostic Test|Blood sampling for total cholesterol and homocysteine and cognitive assessment by psychometric tests.|"all participant are subjected to cognitive assessment by psychometric tests by using the arabic version of Mini Mental State Exam (MMSE) and Memory Assessment Scale (MAS).
~Blood samples were collected in the morning using 10 mL yellow top (plain) Vacutainer tubes.
~Lipid profile (triglycerides, low-density lipoprotein (LDL), and high-density lipoprotein (HDL)) were measured by Assiut university labs using Cholesterol Kits and analyzed by COBAS Integra analyzer.
~Total cholesterol levels were calculated using the sum of the LDL and HDL plus one-fifth of triglyceride levels.
~Samples of serum homocysteine are collected, centrifuged to separate plasma within 30 minutes after venipuncture and stored in specialized container in the Department of Clinical Pathology at (-20◦C) temperature.
~Total homocysteine was measured by ELISA technique, Sinogen kits (Research Use Only) and Statfax-2100 microplate analyzer."
15902368|NCT03631225|Diagnostic Test|Vectra DA|Each arm will have the Vectra DA test however, scores will not be provided for the Usual Care Arm until end of study (12 month time point)
15902369|NCT03631212|Behavioral|Flexiquit|Digital avatar-led Acceptance and Commitment Therapy for smoking cessation
15902378|NCT03631186|Drug|Semaglutide|Patients will be treated with commercially available semaglutide in a prefilled pen injector (FlexTouch® variant) according to routine local clinical practice at the discretion of the treating physician. Other anti-hyperglycaemic treatments will be prescribed at the physician's discretion.
15902918|NCT03626922|Drug|Pembrolizumab|Pembrolizumab 200 mg IV on Day 1 of each 21 day cycle until maximum of 35 cycles.
15902379|NCT03631173|Procedure|Surgical og radiological intervention, antibiotics|Intervention might be a new drainage catheter, replacement of old drainage catheter, reoperation, somatostatin- and antibiotic administration.
15902380|NCT03631160|Device|TAES treatmen|"In the acupoints group patients are treated with low-frequency pulse electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) at SP6 and BL 32 points during the operation in the operating room ,and at CV3 and CV4 acupoints for 45 minutes in postanesthesia Care Unit. After Deqi, electroacupuncture stimulation apparatus is connected with the density wave (2/100 Hz), width 0.25 ms, intensity of 1 ~ 30 milliamp (mA) (gradually increase to the patient's maximum tolerance) and maintained until the end of treatment."
15902381|NCT03631160|Device|Sham TAES treatmen|"Participants in the acupoints group receive shallow acupointing at SP6, BL 32 ,CV3 and CV4 (nonacupoints located 1 inch beside acupoints, about 20mm).Specifically, the acupoint is shamed without manual stimulation and Deqi and the stimulation apparatus is inefficiency without actual current output ."
15902382|NCT03631147|Drug|Rifaximin|400mg bid for 8 weeks
15902383|NCT03631134|Drug|SGLT2 inhibitor|Patients will be gave SGLT2 inhibitor 10mg per day
15902384|NCT03631121|Drug|Basalin to Lantus|continuous glucose monitoring system will used twice when patients are using Basalin and Lantus respectively to assess glycemic variation.
15902385|NCT03631108|Diagnostic Test|OCTA (ZEISS)|All participants will underwent imaging using the OCTA system (Zeiss) with the anterior segment optical adaptor lens.
15902386|NCT03631082|Other|Slump stretching|Slump stretching will be provided to this group along with standardized exercises.
15902387|NCT03631082|Other|Lumbar mobilization|Lumbar mobilizations will be provided to this group along with standardized exercises.
15902388|NCT03631056|Biological|Human Acellular Vessel (HAV)|
15902389|NCT03631043|Procedure|Biopsy Specimen Radiography|Undergo collection of blood and bone marrow
15902390|NCT03631043|Drug|Lenalidomide|Given PO
15902391|NCT03631043|Biological|Vaccine Therapy|Given personalized vaccine SC
15902392|NCT03631030|Device|Cooled radiofrequency ablation|Cooled Radiofrequency ablation (CRFA) is a well-established method for delivering lesions into nervous tissue to accomplish neurotomy procedures
15902393|NCT03631017|Drug|[18F]- PARPi|injection of a microdose (< 100 ug) of [18F]- PARPi
15902394|NCT03631017|Diagnostic Test|PET/CT Scans|"Patients will be injected with approximately 10 mCi of [18F]PARPi and a dynamic PET scan of will be acquired for approximately 30 minutes. A second body PET/CT scan will be started approximately 60 min post injection, and a third PET/CT scan will be started at approximately 120 min post injection. The first (dynamic) and the second (body) PET/CT scan will use ultra -low dose CT scan for attenuation correction. The last PET/CT scan will be performed with the investigator's regular clinical low-dose CT settings."
15902395|NCT03631004|Drug|Olanzapine|olanzapine 10 mg is given before surgery
15902396|NCT03630991|Drug|Edetate Calcium Disodium|Given IV
15902397|NCT03630991|Dietary Supplement|Multivitamin|Given PO
15902398|NCT03630991|Drug|Succimer|Given PO
15902399|NCT03630978|Procedure|Liver resection|Major or minor, open or laparoscopic liver resection
15902400|NCT03630965|Other|CPR Video|"A 7.07 minutes' CPR video will be administered to the ICU patients' surrogates in Group B.
~After viewing the video, the surrogate will complete the Hamilton Anxiety Rating Scale, a five-question survey about CPR, and a one-question form about comfort using the Likert Scale."
15902401|NCT03630952|Biological|0.5 mg Conbercept Intravitreal Injection|Subjects received 0.5 mg conbercept intravitreal injection at Day 1, Week 4 and Week 8 (three injection loading dose), and treated every eight weeks thereafter (0.5 mg, q8w) through Week 36. At the Week 40 visit, the criteria-based pro re nata (PRN) approach will begin through the end of the treatment period at Week 92, for a total of 92 weeks treatment in the study eye.
15902402|NCT03630952|Biological|1.0 mg Conbercept Intravitreal Injection|Subjects received 1.0 mg conbercept intravitreal injection at Day 1, Week 4 and Week 8 (three injection loading dose), and treated every twelve weeks thereafter (1.0 mg, q12w) through Week 36. At the Week 40 visit, the criteria-based PRN approach will begin through the end of the treatment period at Week 92, for a total of 92 weeks treatment in the study eye.
15902403|NCT03630952|Biological|2.0 mg Aflibercept Intravitreal Injection|Subjects received 2.0 mg aflibercept intravitreal injection at Day 1, Week 4 and Week 8 (three injection loading dose), and treated every eight weeks thereafter (2.0 mg, q8w) through Week 36. At the Week 40 visit, the criteria-based PRN approach will begin through the end of the treatment period at Week 92, for a total of 92 weeks treatment in the study eye.
15902404|NCT03630939|Drug|ESR-114|ESR-114 Topical Gel
15902405|NCT03630939|Other|Placebo|Placebo Topical Gel
15902406|NCT03630926|Diagnostic Test|NV-VPAC1 PCa Urine Diagnostic Test|The NV-VPAC1 PCa Urine Diagnostic Test is intended for use by clinicians to detect the presence of prostate cancer cells shed in voided urine of men at risk for prostate cancer.
15902407|NCT03630913|Procedure|Tagged axillary metastatic node|"First, initially metastatic lymph node is tagged with a metal clip under sonography. Then, patients receive NAC before surgery.
~Breast surgery (conservative or radical) and axillary surgery are performed during the same procedure, 4 to 6 weeks after completion of NAC.
~SLN isotope detection is performed with or without blue dye. All patients undergo the resection of the tagged axillary node, SLN biopsy and a complementary axillary lymphadenectomy."
15902408|NCT03630900|Other|Sequential O2 Culture|We investigate the effect of sequential O2 levels on human embryo culture after Intracytoplasmic sperm injection (ICSI)
15902409|NCT03630887|Device|WarmTouch Model 5900, Covidien Ltd, Mansfield, USA|Forced-air warming will be applied in the preanesthetic room during different time periods.
15902410|NCT03630874|Other|Evaluate the impact of a prescription support tool|"From a systematic review of international guidelines (2012-2018), we developed a prescription support-tool synthesizing national and international guidelines on chronic management (≥ 1 month) of oral AT agents without considering in-hospital management and bridging therapy.
~In the experimental group, the tool will be provided with an explanatory guide. Selected physicians will receive 3 different clinical vignettes, each corresponding to a specific situation for which the physician will have to indicate (thanks to the tool) the right prescription of ATs by answering a multiple-choice question, with the number, type, duration and dosage of AT provided."
15902411|NCT03630848|Other|Effect of Protein on Blastocyst Development|Embryo Development Related to The Protein Concentration
15902413|NCT03630822|Behavioral|Psychiatric Advanced Directive|The patient completes a questionnaire to express in advance his wishes regarding his future care in psychiatry.
15902414|NCT03630822|Behavioral|Standard care|standardized maintenance with the patient
15902416|NCT03630796|Drug|Sevoflurane|Use of sevoflurane (compared to total intravenous anesthesia) in congenital heart deffects surgeries.
15902417|NCT03630796|Drug|TIVA|Total intravenous anesthesia
15902418|NCT03630783|Behavioral|Combined Cognitive Bias Modification|
15902419|NCT03630770|Drug|Medium-Chain Triglyceride (MCT) Oil|Infants receive 0.5 ml/oz of MCT oil to their prescribed feedings for 21 days or until hospital discharge.
15902420|NCT03630757|Other|Treatment|In the study group, a total of 15 sessions of a manual therapy program including myofascial release and mobilization techniques were applied for 60-minute session for 3 weeks(5/wk).
15902421|NCT03630744|Other|Fluid therapy|"Analyze the type of fluid administered:
~crystalloids:
~Saline serum 0.9% ....... ml
~Ringer Lactate ........ ml
~Isofundin ® ........ ml
~Plasmalyte® ... ... ml
~Glucose Serum 5% ....... ml
~Glucose serum 10% ........ ml
~Glucosaline serum ........ ml
~colloids:
~Hydroxyethyl starch 130 / 0.4 ... ... ml
~Hydroxyethyl alimdon 130 / 0.42 ... .... ml
~Gelatins ... ....... ml
~Albumin 5% .......... ml
~Albumin 20% .......... ml.
~Analyze the total amount of crystalloids and liquid colloids administered in 24 hours in milliliters.
~Analyze the form of administration:
~Standard
~Standard with dosimeters
~on pump"
15902422|NCT03630731|Drug|chidamide|For those who responded to induction chemotherapy, chidamide will be given OR orally 30mg biw for at least half a year
15902423|NCT03630718|Behavioral|Psychoeducational Intervention|"The psychoeducational intervention will be a structured education programme and will consist of informing patients about fatigue dimensions, aetiology and treatments, by helping them to develop strategies to cope with fatigue better and by teaching them to manage the balance between activities and rest.
~The construction of the contents of the sessions of this intervention will aim to reduce fatigue via the programme developed by Reif et al. in cancer patients and is composed of 6 sessions of 90 minutes, one session per week. It is a group intervention for 8 patients. For this project, the investigators have reorganised the sessions and their content to fit with an individual format adapted to PBC. This format is more appropriate to take into account the specificity of the manifestation of fatigue for each patient."
15902424|NCT03630718|Behavioral|Hypnosis intervention|"The hypnosis intervention will consist of decreasing fatigue and the related distress, and increasing feelings of energy and well-being.
~Therefore, each hypnosis exercise will be audiotaped and given to the patient at the end of the session. Patients will be asked to use these recordings as much as they want to help them to manage fatigue. The techniques used are inspired by those used in chronic pain management and fatigue."
15902425|NCT03630705|Biological|Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine|Pharmaceutical form: Liquid solution Route of administration : Intramuscular
15902426|NCT03630705|Biological|Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine|Pharmaceutical form: Lyophilized powder combined with liquid component Route of administration : Intramuscular
15902427|NCT03630705|Biological|Measles, Mumps, and Rubella Virus Vaccine Live|Pharmaceutical form: Lyophilized live virus vaccine Route of administration : Subcutaneous
15902428|NCT03630705|Biological|Pneumococcal 13-valent Conjugate Vaccine|Pharmaceutical form: Suspension for injection Route of administration: Subcutaneous
15902429|NCT03630705|Biological|Diphtheria, Tetanus, Pertussis (Acellular, Component) Poliomyelitis (inactivated) Vaccine, and Haemophilus influenza type b Conjugate Vaccine|Pharmaceutical form: Powder and suspension for injection Route of administration: Subcutaneous
15902430|NCT03630705|Biological|Hepatitis B Vaccine|Pharmaceutical form: Suspension for injection Route of administration: Subcutaneous
15902431|NCT03630705|Biological|Rotavirus Vaccine, Live, Pentavalent|Pharmaceutical form: Oral solution Route of administration: Oral
15902432|NCT03630705|Biological|Diphtheria, tetanus, pertussis (acellular component), hepatitis B, poliomyelitis (inactivated), and Haemophilus influenzae type b conjugate vaccine|Pharmaceutical form:Suspension for injection Route of administration: Intramuscular
15902433|NCT03630692|Drug|observance of oral drug treatment|Completion of questionnaires at 4 times during patient's oral route drug treatment
15902434|NCT03630666|Drug|IADT|Patient will receive one injection of IADT at randomization
15902435|NCT03630666|Combination Product|IADT + radiotherapy|Patient will receive one injection of IADT at randomization then will receive irradiation 3 months after injection of IADT
15902436|NCT03630653|Procedure|Sentinel LN in breast cancer recurrence|Sentinel Lymph-Node (LN) procedure and Axillary LN dissection ; Mastectomy or breast conservative surgery
15902437|NCT03630640|Drug|Nivolumab Injection [Opdivo]|Intravenous Nivolumab 240 Q2W neoadjuvant Intravenous Nivolumab 480 mg Q4W- adjuvant up to 12 months after EP
15902438|NCT03630627|Drug|SB26|SB26 administered intravenously
15902439|NCT03630627|Drug|Placebo|Placebo administered intravenously
15902463|NCT03630445|Other|Xtend® sucromalt|Xtend® sucromalt incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.
15902919|NCT03626922|Drug|Pemetrexed|Pemetrexed 500 mg/m2 IV on Day 1 of each 21 day cycle until maximum of 35 cycles.
15902440|NCT03630614|Drug|Electronic cigarette without nicotine (ECwN) plus active varenicline tablets|"The ECwN group use EC liquids containing 0 mg/mL of nicotine. Because nicotine delivery can be adjusted according to the user's need, all participants are able to adjust their individual nicotine dose by varying the wattage of their EC, by varying puff frequency and puff volume similarly as they are doing (or used to do) with conventional cigarettes.
~EC device:
~Mini iStick kit (20 W) Eleaf Clearomiser :GS Air M with resistance of 1.5 ohm, the clearomiser's Pyrex window is of blue colour not allowing to distinguish an eventual coloration of the e-liquid containing nicotine. Liquids for EC use are delivered in white opaque 10 mL vials not allowing to distinguish the color of the liquid.
~Varenicline, Champix® 0.50 mg tablets Posology of vareniclin follows varenicline's monograph."
15902441|NCT03630614|Drug|Electronic cigarette without nicotine (ECwoN) plus placebo tablets of varenicline|"The ECwoN group receives EC liquids with 0 mg/mL of nicotine on a double blind manner (in identical non-transparent refill bottles of 10 mL).
~Placebo of varenciline The placebo of varenicline is presented as a capsular-shaped, biconvex, white film-coated tablet. Posology of varenicline or its placebo follows varenicline's monograph."
15902442|NCT03630614|Drug|Electronic cigarette with nicotine (ECwN) plus placebo tablets of varenicline|The ECwN group use EC liquids containing 12 mg/mL of nicotine. Placebo of varenciline The placebo of varenicline is presented as a capsular-shaped, biconvex, white film-coated tablet. Posology of varenicline or its placebo follows varenicline's monograph.
15902443|NCT03630601|Procedure|Photoacoustic Imaging|Undergo PAI
15902444|NCT03630588|Combination Product|Surimi intervention|"The bioactive compounds used to obtain the surimi product are:
~Inulin (3.4 grams per 100 grams of surimi, 1.7 grams per 50 grams of surimi): Obtained from Chicory originating in Europe.
~EPA + DHA (740 mg per 100 g of surimi, therefore 370 mg per 50 g): Obtained from sardine and anchovy fish oil, encapsulated in tilapia gelatine, originating in the United States.
~Probiotic BPL1
~It was a 3 months nutritional intervention. Volunteers will eat 50g per day of enriched surimi."
15902445|NCT03630588|Combination Product|Placebo|"Conventional surimi
~It was a 3 months nutritional intervention. Volunteers will eat 50g per day of conventional surimi."
15902446|NCT03630575|Procedure|Umbilical cord blood and hair collection|At the birth of the newborn, a first hair sample and a cord blood sample will be taken. A follow-up of the newborn will be performed between 4 and 6 months in order to obtain a second hair sample.
15902447|NCT03630562|Procedure|Aqueous humor samples collection|In addition to the routine examinations performed as part of the usual care of AMD patients, an anterior chamber puncture will be performed to collect the aqueous humor samples.
15902448|NCT03630549|Other|Standard of Care|Clinic-based HIV care
15902449|NCT03630549|Other|Village-based ART refill|Option to get ART refill and care by the village health worker
15902450|NCT03630523|Biological|Influvac Tetra|Tetravalent seasonal flu vaccination 2018/2019
15902451|NCT03630510|Other|Ventilator hyperinflation|The ventilator hyperinflation maneuver with inspiratory time adjustment was performed in the pressure controlled ventilation mode (PCV). The inspiratory pressure was increased gradually every 5 cmH2O until reaching a maximum pressure of 35 cmH2O, according to the tolerance of the patient determined by the absence of cough. PEEP remained unchanged throughout the study. After reaching a maximum pressure of 35 cmH2O (PCV + PEEP level), the inspiratory time was gradually increased until the inspiratory flow reached the baseline. Concomitantly, the respiratory rate was decreased to allow the expiratory flow also to reach the baseline, to avoid self-PEEP. The maneuver was performed for 5 min, followed by tracheal aspiration.
15902452|NCT03630497|Drug|Comparison of BN201 treatment with Placebo|Single Dose or Multiple Dose of BN201 IV administration
15902453|NCT03630484|Other|Expiratory Rib Cage Compression|Compression was performed in 6 sets of 6 cycles, with 1 cycle interval. Ventilatory mode and parameters were maintained.
15902454|NCT03630484|Other|Compression + Ventilator Hyperinflation|Mechanical ventilator hyperinflation was performed by increasing the inspiratory pressure to every 5 cmH2O until the total pressure reached 40 cmH2O, remaining the same. In Expiratory Rib Cage Compression associated with ventilator hyperinflation, thoracic compression maneuver was performed at the end of inspiration, at the exact moment of cycling.
15902455|NCT03630471|Behavioral|PRIDE 'Step 1' problem-solving intervention|"The PRIDE problem-solving intervention is one component of the PRIDE stepped care treatment architecture which comprises two sequential treatments of incremental intensity. 'Step 1' is a brief, first-line treatment. It is grounded in stress-coping theory, with a technical focus on practical problem-solving to modify developmentally salient stressors.
~Step 1 has been designed as a 'low-intensity' intervention requiring fewer resources than conventional psychological treatments. This is achieved through a relatively brief delivery schedule (up to 5 x 20-30-minute sessions spread over approximately 3 weeks) and limited requirement for specialists. The delivery agents are lay counsellors receiving a combination of specialist and peer supervision. The counsellors offer guidance sessions to support the learning and implementation of problem-solving and complementary coping skills. Illustrated booklets are used to support learning of problem-solving concepts and skills practice at home."
15902456|NCT03630471|Behavioral|Enhanced usual care|There is no established mental health service provision in the collaborating schools. The control arm participants will receive an enhancement of this 'usual care' (essentially, no care) by having access to the same illustrated booklets used in the Intervention arm, albeit without any counsellor contact.
15902457|NCT03630458|Other|Pearl millet couscous - made in Senegal|Pearl millet couscous (made in Senegal) was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response.
15902458|NCT03630458|Other|Pearl millet couscous - made in USA|Pearl millet couscous (made in USA) was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response.
15902459|NCT03630458|Other|Pearl millet thick porridge|Pearl millet thick porridge was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response.
15902460|NCT03630458|Other|Wheat couscous|Wheat couscous was tested for gastric emptying rate, glycemic response, fermentability, and appetitive response.
15902461|NCT03630458|Other|White rice|White rice was tested as a comparator for gastric emptying rate, glycemic response, fermentability, and appetitive response.
15902462|NCT03630445|Other|Isomaltooligosaccharides (IMOs)|Isomaltooligosaccharides (IMOs) incorporated into yogurt were tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.
15902579|NCT03629652|Other|head-down position treatment|In the head-down position, the body is in the supine position with the head lowered to 30 degrees
15902464|NCT03630445|Other|Combination of IMOs and Xtend® sucromalt|A combination of IMOs and Xtend® sucromalt incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.
15902465|NCT03630445|Other|Raw corn starch|Raw corn starch incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.
15902466|NCT03630445|Other|Maltodextrin|Maltodextrin incorporated into yogurt was tested for gastric emptying rate, glycemic response, appetitive response, and fermentability.
15902467|NCT03630432|Behavioral|Pulmonary rehabilitation|"The pulmonary rehabilitation course will be provided on a rolling basis and for each individual will be of 8 weeks duration including once weekly, 1.5 hour hospital sessions and encouragement to perform twice weekly home exercise sessions. Hospital sessions will include 1 hour of supervised exercise and 30 minutes education.
~Exercise Component: This will include a combination of aerobic, resistance and flexibility training.
~Educational Component will cover many topics including what is asthma, treatments and inhaler technique, self-management, importance of exercise and health promotion.
~On completion of the formal pulmonary rehabilitation course, participants will be encouraged to continue regular exercise sessions by accessing community based Vitality Classes."
15902468|NCT03630432|Other|Usual Care|Usual Care
15902469|NCT03630419|Dietary Supplement|Mito-Food Plan|Specialized anti-inflammatory diet plan based on subject's physiological results
15902470|NCT03630419|Other|Cellular Repair Therapy|the objective of this type of technology is to support the body's own processes to repair protein structures and maintain the health of the DNA, both of which have been damaged by internal and external factors.
15902471|NCT03630406|Diagnostic Test|Vaginal Tactile Imaging|Vaginal Tactile Imaging
15902472|NCT03630393|Other|Pneumoperitoneum Pressure 6 mmHg|A pneumoperitoneum insufflation pressure of 6 mmHg will be used during RALP.
15902473|NCT03630393|Other|Pneumoperitoneum Pressure 15 mmHg|A pneumoperitoneum insufflation pressure of 15 mmHg will be used during RALP.
15902474|NCT03630380|Other|Clinical History|We will collect clinical history for each patient (days of illness, history of fever, cough, difficulty breathing, vomiting, chest pain).
15902475|NCT03630380|Other|Physical Exam Findings|We will collect physical exam findings including vital signs, WHO criteria for diagnosing pneumonia, and lung auscultation findings.
15902476|NCT03630380|Other|Laboratory Findings|We will collect laboratory findings (white blood cell counts, differential, and c-reactive protein) if ordered by the clinician.
15902477|NCT03630380|Other|Lung Ultrasound|We will perform lung ultrasound on all patients.
15902478|NCT03630367|Drug|Dexamethasone|Intramuscular injection 8 mg
15902479|NCT03630367|Drug|L-Carnitine 1G/5mL Injection|slow intravenous injection
15902480|NCT03630354|Behavioral|Exercise Intervention|Complete supervised exercise
15902481|NCT03630354|Behavioral|Exercise Intervention|Complete unsupervised exercise
15902482|NCT03630354|Other|Informational Intervention|Receive instructional DVD
15902483|NCT03630354|Other|Questionnaire Administration|Ancillary studies
15902484|NCT03630341|Drug|Clomiphene Citrate 50mg|oral 50 mg tablets
15902485|NCT03630341|Drug|L-carnitine|1000 mg oral tablet
15902486|NCT03630341|Drug|Placebo Oral Tablet|oral tablets identical to L-carnitine
15902487|NCT03630328|Dietary Supplement|Cogni.Q|AGN
15902488|NCT03630328|Other|Placebo|Placebo
15902489|NCT03630315|Drug|OTX-TKI|OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).
15902490|NCT03630315|Drug|OTX-TKI|OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).
15902491|NCT03630315|Drug|OTX-TKI|OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).
15902492|NCT03630315|Drug|OTX-TKI|OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).
15902493|NCT03630315|Drug|Anti-VEGF|Standard of care therapy used to block vascular endothelial growth factor
15902494|NCT03630315|Drug|OTX-TKI|OTX-TKI is a dried polyethylene glycol-based hydrogel fiber containing dispersed microcrystals of a small molecule tyrosine kinase inhibitor (TKI).
15902495|NCT03630315|Drug|Anti-VEGF|Standard of care therapy used to block vascular endothelial growth factor
15902496|NCT03630302|Device|DBS|Deep Brain Stimulation
15902498|NCT03630276|Diagnostic Test|Neutrophil/lymphocyte ratio, Platelet /lymphocyte ratio and CRP|Lab
15902499|NCT03630263|Other|Raw Corn Starch|Raw corn starch (30 g) will be added to 200 g of applesauce and served to participants, gastric emptying rate, and postprandial glucose will be measured.
15902500|NCT03630263|Other|No Raw Corn Starch|200 g of applesauce will be consumed and gastric emptying rate, and postprandial glucose will be measured.
15902501|NCT03630250|Biological|N. lactamica|Genetically modified N. lactamica
15902502|NCT03630224|Drug|Plasmalyte Viaflo|Intervention description: fluid resuscitation using exclusively Plasmalyte up to 20L during the first 5 days
15902503|NCT03630224|Drug|NaCl 0.9%|Intervention name: NaCl 0.9% Intervention description: fluid resuscitation using exclusively NaCl 0.9% up to 20L during the first 5 days
15902504|NCT03630211|Drug|Cyclophosphamide|Stem Cell Mobilization
15902505|NCT03630211|Drug|Mesna|Stem Cell Mobilization
15902506|NCT03630211|Drug|Rituximab|Transplantation Conditioning
15902507|NCT03630211|Drug|Alemtuzumab|Transplantation Conditioning
15902508|NCT03630211|Drug|Thiotepa|Transplantation Conditioning
15902509|NCT03630211|Drug|GM-CSF|Transplantation Conditioning
15902510|NCT03630211|Drug|Intravenous immunoglobulin|Transplantation Conditioning
15902511|NCT03630211|Radiation|Total Body Irradiation|Transplantation Conditioning
15902512|NCT03630198|Drug|Corticosteroid with lidocaine|Intralesional corticosteroid injection
15902513|NCT03630198|Drug|Corticosteroid with normal saline|Intralesional corticosteroid injection
15902514|NCT03630185|Device|Custom-manufactured compression hosiery (Isobar)|The custom-fitted garment is manufactured specifically for each patient based on measurements taken with a 3-dimensional volumetric laser scan of the extremity, and can be sized individually to each limb.
15902515|NCT03630185|Device|Off-the-rack stockings (Sigvaris)|Currently available off-the-rack compression hosiery are manufactured in eight fixed sizes (S-XLFC) that cannot be varied in size over their length to accommodate unusual anatomic patterns (eg., small ankle with large calf or vice versa) and may not achieve a comfortable fit that meets the compression goal over a uniform distribution of the limb.
15902516|NCT03630172|Procedure|Dry needling|Using a thin, filiform needle to penetrate a muscle and its trigger point to produce a local twitch response
15902517|NCT03630159|Biological|Tisagenlecleucel|Gene modified autologous T cells
15902518|NCT03630159|Drug|Pembrolizumab|anti PD-1
15902519|NCT03630146|Behavioral|iPeer2Peer program|In addition to standard care, youth in the experimental group will receive the iPeer2Peer Program. The iPeer2Peer program is a peer mentorship program that will provide modeling and reinforcement of self-management by pre-screened and trained peer mentors (young adults with IBD aged 18-25 years) who have learned to function successfully with their disease. Mentors will encourage youth to develop and engage in disease self-management skills and provide social support.
15902520|NCT03630146|Other|Waitlist control|The control group will receive standard care but without the iPeer2Peer Program.
15902521|NCT03630133|Device|Intracept System Ablation|Radiofrequency ablation using Intracept System
15902522|NCT03630120|Drug|Lenvatinib|"Standard of Care: Lenvatinib 24 mg daily. All participants will start receiving standard of care treatment.
~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level."
15902523|NCT03630120|Drug|Sorafenib|"Standard of Care: Sorafenib 400 mg twice daily. All participants will start receiving standard of care treatment.
~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level."
15902524|NCT03630120|Drug|Cabozantinib|"Standard of Care: Cabozantinib 140 mg daily. All participants will start receiving standard of care treatment.
~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level."
15902525|NCT03630120|Drug|Vandetanib|"Standard of Care: Vandetanib 300 mg daily. All participants will start receiving standard of care treatment.
~Participants in the Adaptive Therapy regimen will receive TKI therapy in cycles: continuous treatment at the indicated dose until the patients' tumor marker (thyroglobulin in DTC or calcitonin in MTC patients) drops by ≥50% from the level at the time of enrollment (baseline level). A new cycle of TKI treatment will begin when/if the tumor marker increases to or above the baseline level."
15902526|NCT03630107|Other|WO 5101 Shampoo for Scalp and Hair|Wash the hair at least three times a week for a period of four weeks
15902527|NCT03630094|Drug|FEP-ZID|A total of 7 doses of FEP-ZID via intravenous infusion over 60 min at q8hr dosing regimen
15902528|NCT03630081|Drug|FEP-TAZ 4 g|4 g (2 g FEP and 2 g TAZ) IV q8h, infused over 90 min
15902529|NCT03630081|Drug|Meropenem|1 g IV q8h, infused over 45 min
15902530|NCT03630081|Drug|ciprofloxacin 500 mg Optional Oral Switch|ciprofloxacin 500 mg PO q12h
15902531|NCT03630081|Other|Placebo infusion|Placebo infusion (normal saline) over 45 min
15902532|NCT03630068|Procedure|Stereotactic percutaneous image-guided microwave ablation|Stereotactic percutaneous image-guided microwave ablation implies the use of computer-assisted navigation technology for 3D trajectory planning and stereotactic placement of ablation probes, before applying local microwave ablation therapy
15902533|NCT03630055|Drug|Rivaroxaban 15 MG Oral Tablet [Xarelto]|Patients will receive rivaroxaban 15mg orally daily for 7 days following transradial access.
15902534|NCT03630042|Drug|Pembrolizumab|200 mg IV dose given on day 1 of a three week cycle
15902535|NCT03630042|Drug|Rituximab|375 mg/m2 IV dose given up to 8 times in the trial
15902536|NCT03630029|Drug|FeS and SnPP|Escalating doses of drug will be compared for biomarker changes
15902537|NCT03630016|Diagnostic Test|Pulse oximetry with Owlet BabySat v1.0 sensor|A comparative, single-center, non-randomized study to evaluate the SpO2 accuracy guidelines for pulse oximetry over the range of 70-100% SaO2 under non-motion conditions. Arterial blood sampling measured by functional SaO2 CO-Oximetry, was used as the basis for comparison with Owlet BabySat v1.0 and Owlet Smart Sock 2 sensors
15902538|NCT03630003|Device|MOCS|"The device consists of a tablet computer that can produce visual and auditory components designed to improve subject knowledge about setting and communication, mounted on a table or at the side of the bed in a place that is visible to the subject.
~The Arduino will be connected to switches/buttons and implemented in a 3D-printed platform."
15902539|NCT03630003|Other|Post-use interview|The Study team conducts an interview with participants to evaluate their experience with use of the MOCS device.
15902540|NCT03629990|Behavioral|Approach Bias Modification (ABM)|Approach bias modification (ABM) is a novel treatment that involves retraining the implicit action tendency to approach a drug cue by manipulating contingencies in a stimulus-response paradigm.
15902541|NCT03629990|Behavioral|Sham ABM|"Sham ABM involves similar computerized procedures that mimic the active experimental condition, but do not involve manipulation of response contingencies and thus it does not contain any active intervention."
15902542|NCT03629990|Behavioral|Psychosocial therapy for cannabis use disorder.|All participants will receive psychosocial therapy for cannabis use disorder.
15902543|NCT03629977|Device|CRRT|Continuous Renal Replacement Therapy
15902544|NCT03629964|Device|Wiersma Head Stabilizer|Experimental device attached to treatment table.
15902580|NCT03629652|Other|Conventional Rehabilitation|The body is in the supine position without lowered head
15902545|NCT03629964|Device|AlignRT system|The AlignRT system (an FDA approved medical device that automatically turns off the radiation beam if the head moves beyond a set distance) will be used to track real-time motions of the head. This system is used with radiation therapy as standard of care.
15902547|NCT03629938|Other|evaluation|evaluation and classification of medial longitudinal arch height of foot in adults
15902548|NCT03629925|Drug|Sintilimab|200mg, Q3W, day1, I.V.; consecutive cycles
15902549|NCT03629925|Drug|Gemcitabine|1000mg/m^2, Q3W, day 1and 8, I.V.; first 4 or 6 consecutive cycles.
15902550|NCT03629925|Drug|Cisplatin|75 mg/m^2, Q3W, day1, I.V.; first 4 or 6 consecutive cycles.
15902551|NCT03629925|Drug|Placebo|NA, Q3W, day1, I.V.; consecutive cycles
15902552|NCT03629925|Drug|Carboplatin|AUC 5mg/ml/min, Q3W, day1, I.V.; first 4 or 6 consecutive cycles.
15902553|NCT03629912|Behavioral|Socially-Based Exercise Intervention for Older Adults|A socially-based app that incorporates exercise and/or health education into a format familiar and engaging to older adults, designed to improve adherence to health-promoting behaviors
15902554|NCT03629899|Device|RETINA IMPLANT Alpha AMS|Implantation of the subretinal RETINA IMPLANT Alpha AMS
15902555|NCT03629886|Biological|HPV (Types 16, 18) Vaccine, Adsorbed|Three doses of Human Papillomavirus (Types 16, 18) Vaccine, Adsorbed administered intramuscularly in the deltoid region of the upper arm, according to a 0, 1, 6-month schedule.
15902556|NCT03629873|Drug|Chidamide|Chidamide 30mg po d-7、-4、0、3; Carmustine 300mg/m^2 IVD d-6; Etoposide 150mg/m^2/d qd IVD d-5~-2; Cytarabine 150mg/m^2 q12h IVD d-5~-2; Cyclophosphamide 1.0g/m^2/d qd IVD d-5~-2
15902557|NCT03629860|Procedure|Atrophic maxillary alveolar ridge augmentation|Autogenous bone blocks from chin and ascending ramus are obtained and used for reconstruction of atrophic maxillary ridges
15902558|NCT03629847|Drug|Everolimus|Drug: Everolimus will be administrated in combination with the intravenous radiolabelled Lu-177 DOTATATE therapy.
15902559|NCT03629834|Diagnostic Test|Epworth Sleepiness Scale|Maintenance Wakefulness Test
15902560|NCT03629821|Other|Ballet|The classic ballet classes will respect biological limits of children. The sessions will be 75 minutes long, twice a week during 8 weeks. The class sequence will be: warm-up, follow by exercises about upper and lower limbs ballet positions and sequences of ballet jumps, and at the end a cool-down.
15902561|NCT03629808|Procedure|4-6cm from starting point of gastrectomy to pylorus|The starting point of gastrectomy of the distance from the pylorus is 4-6cm during operative.
15902562|NCT03629808|Procedure|2-4cm from starting point of gastrectomy to pylorus|The starting point of gastrectomy of the distance from the pylorus is 2-4cm during operative.
15902563|NCT03629769|Drug|Proxelan|Administration of one suppository of proxelan once a day for 30 days
15902564|NCT03629756|Drug|Etrumadenant|Etrumadenant is an A2aR and A2bR antagonist.
15902565|NCT03629756|Drug|Zimberelimab|Zimberelimab is a fully human anti-PD-1 monoclonal antibody.
15902566|NCT03629743|Device|EEG|EEG will be collected with Brain Product's VAMP-16 channel EEG Monitor using the accompanying software. (Website with further specifications and product details: https://www.brainproducts.com/productdetails.php?id=15)
15902567|NCT03629743|Device|ECOG|ECOG will be collected with Nihon Kohden acquisition System and accompanying software and depth electrodes.
15902568|NCT03629730|Behavioral|Coordination training|The intervention will consist of 8 weeks of exercises to decrease the variability of participants' body and gait coordination. The intervention will consist of 1 training session /week in the Mobility Research Laboratory and 4 days of home-based training. In each session participants will perform 6 trials of 4 body coordination exercises and 1 gait exercise. In the intervention sessions participants will perform interlimb coordination exercises, synchronizing body segments with auditory metronome tones. Participants also will perform a gait exercise by synchronizing steps with an auditory metronome during walking. The metronome will assist participants to retrain their movement timing to decrease coordination variability.
15902569|NCT03629717|Procedure|Ultrasound-guided core needle biopsy|Tissue collection for this research proposal will be used for research purposes only and will not inform participant care
15902570|NCT03629717|Drug|Denosumab|Denosumab is a human IgG2 monoclonal antibody with affinity and specificity for human RANKL
15902571|NCT03629717|Procedure|Blood draw|20 mL of fasting whole blood will be collected before denosumab (Day 1) and one month after denosumab administration (day 60 +/- 10 days)
15902572|NCT03629717|Drug|Calcium|1200mg daily
15902573|NCT03629717|Drug|Vitamin D|800 IU daily
15902574|NCT03629704|Diagnostic Test|Continuous Glucose Monitoring System|Continuous Glucose Monitoring System for 72 hours
15902575|NCT03629691|Other|lung cavitation|apatinib treated patients developed lung cavitation
15902576|NCT03629678|Other|mobile health application|The user-driven technological tool will include an mHealth mobile phone application. Features of the application will be based on preliminary work from the investigators' sites. The mobile app will include fully searchable provider-facing and patient-facing interfaces with the SCD-specific guidelines. The provider-facing interface, designed to be used by providers, will be separated by patient's age to accommodate pediatric and adult providers. The patient-facing interface will display the guidelines that are age- and health literacy-appropriate. Through the mobile app, the investigators will reinforce important points of guideline content; motivate patient engagement through quizzes and text-message reminders; and facilitate peer support, for instance by forming teams to compete against each other to attain goals.
15902577|NCT03629665|Behavioral|Intensive Language-Action Therapy (ILAT)|ILAT includes communicative language games played in an interactive small-group setting. Three persons with aphasia and one therapist sit around a table and have picture cards in front of them. The card sets include two items of each object or action picture. All participants take turns in making verbal requests. There will be 5 daily sessions (3 hours per session) for two weeks.
15902578|NCT03629665|Device|Repetitive navigated Transcranial Magnetic Stimulation during naming training|Magnetic stimulation will delivered with a figure-of-eight cooled coil of Navigated Brain Stimulation System during picture naming training. The primary targeted area is the right pars triangularis. In each session, rTMS will be applied at 1-Hz for 20 minutes, 5 daily sessions per week for four weeks.
15902581|NCT03629639|Drug|Metformin|An intervention of either metformin or placebo 500mg twice daily plus standard care for 12 weeks. Besides Metformin, standardized topical treatment is given to all patients; For severe psoriasis patients(PASI>8), Methotrexate will be treated orally 7.5mg every week for both the intervention group and the placebo group as a systemic standard care.
15902582|NCT03629626|Procedure|ERAS protocol|"preoperative management Optimization of relevant medical uncontrolled situations, avoid fasting, avoid bowel preparation, avoid premedications, nutritional assessment, stop smoking, stop alcohol and appropriate counselling
~intraoperative management Multimodal prevention of prophylaxis against nausea and vomiting (PONV) (according to preoperative assessment of Apfel Score) with a combination of multiple antiemetic drugs.
~postoperative management Postoperative pain control is obtained with opioid sparing strategies, in order to avoid Post Operative Ileus (POI) and PONV.
~It is proposed to chew gum three times daily , fluid therapy, early mobilization, early feeding within 2 hours postoperative for at least 15 minutes and eventually to promote a faster bowel function."
15902583|NCT03629613|Dietary Supplement|Oral antioxidant cocktail|"Oral antioxidant cocktail intake will occur after baseline measurements:
~Dose 1 (immediately after baseline testing): 300 mg alpha-lipoic acid, 500 mg vitamin C, 200 IU vitamin E Dose 2 (30 minutes after Dose 1): 300 mg alpha-lipoic acid, 500 mg vitamin C, 400 IU vitamin E"
15902584|NCT03629613|Other|Baseline|No oral antioxidant cocktail intake or placebo intake will occur prior to baseline measurements
15902585|NCT03629600|Drug|Lactated Ringer|High-volume Lactated Ringer Solution
15902586|NCT03629600|Drug|Rectal Form Indometacin|Post-ERCP rectal administration of 100 MG Indomethacin
15902587|NCT03629574|Procedure|Ventilation during cardiopulmonary bypass|Mechanical ventilation during cardiopulmonary bypass
15902588|NCT03629548|Procedure|early amniotomy|10 mg PGE2 vaginal ovul will be inserted to the posterior fornix. Early amniotomy will be done in the early active phase of labor for early amniotomy group ( half of participants) when the cervix will be dilated 3 cm using the amniotomy hook.
15902589|NCT03629548|Device|foley catheter balloon placement|an 18-F Foley catheter which filling with 30 mL of saline solution will be placed into the cervix and after placement of balloon catheter 10 mg PGE2 vaginal ovul will be inserted to the posterior fornix
15902590|NCT03629535|Device|Non-invasive non-oscillometric blood pressure wristband device|The device is a band intended to be worn on the wrist for intermittent blood pressure measurements. The device applies no inflatable mechanics or moving parts. The wristband is watertight and can be worn as any type of bracelet.
15902591|NCT03629535|Device|Invasive intra-arterial blood pressure monitors.|Because the subjects also have an intra-arterial blood pressure monitor in place, the subjects will serve as their own control
15902592|NCT03629522|Drug|Ondansetron 8Mg/4mL Injection|investigators administrated intravenously Ondansetron 8 mg 5 minutes before spinal anesthesia.
15902593|NCT03629509|Behavioral|BEFORE decision aid|Implementation of the BEFORE decision aid in clinical practice
15902594|NCT03629509|Behavioral|BEFORE decision aid|Implementation of the BEFORE decision aid on RUBY communication portals
15902595|NCT03629509|Behavioral|BEFORE decision aid|Review impact of BEFORE decision aid implementation in clinical practice
15902596|NCT03629496|Other|Arts-based intervention|6x1 hourly facilitated art sessions during haemodialysis. Participants will be provided with an option of visual art or creative writing, the artistic materials used will include graphite pencils, colouring pencils, water colour paints and graphic pens. Participants will be provided with their own art supplies for infection control purposes. During each session participants will be allowed to self-select a subject matter or be provided with binary prompts to facilitate decision making. Participants will also have an option of displaying completed work in the reception area of the unit during their haemodialysis sessions.
15902597|NCT03629483|Drug|Dexmedetomidine|Patients in this group receive continuous femoral nerve block analgesia for 48 hours after surgery. The formula is a mixture of 0.2% ropivacaine 250ml and 3.75 ug/kg dexmedetomidine. The analgesic pump is set to administer a continuous infusion at a rate of 5 ml/h (equivalent to a dexmedetomidine infusion at a rate of 0.075 ug/kg/h).
15902598|NCT03629483|Drug|Placebo|Patients in this group receive continuous femoral nerve block analgesia for 48 hours after surgery. The formula is a mixture of 0.2% ropivacaine 250 ml and placebo. The analgesic pump is set to administer a continuous infusion at a rate of 5 ml/h.
15902601|NCT03629457|Behavioral|Mindfulness and Mindful Self-Compassion|Mindfulness Based Stress Reduction (MBSR) and Mindful Self-Compassion
15902602|NCT03629444|Radiation|ct scan|all patients will be subjected to CT scan and anthroprometric measurments
15902603|NCT03629431|Procedure|Prophylactic non-invasive ventilation|"The sessions of NIV last 1 hour and are repeated every 2 to 3 hours with a goal of a daily assistance period of 6 to 8 hours for a minimum of 24 hours.
~The sessions are spaced by periods of unassisted ventilation of 2 hours allowing the patient to rest, feed, receive care including physiotherapy sessions."
15902604|NCT03629431|Procedure|postoperative standard care|Standard care received postoperatively
15902605|NCT03629418|Drug|Targeted blood-pressure management|Prophylactic norepinephrine infusion is started before anesthetic induction and maintained throughout surgery. The target is to maintain systolic blood pressure at 110 mmHg or higher.
15902606|NCT03629418|Drug|Routine blood-pressure management|Phenylephrine (25-50 ug) is injected or vasopressors is infused only when necessary. The target is to maintain systolic blood pressure at 90 mmHg or higher during surgery.
15902607|NCT03629405|Other|C - pH 4 Cosmetic Product WO 3741|Application of the product on the pre-defined skin area on the forearms twice daily for four weeks
15902608|NCT03629405|Other|D - pH 5.8 Cosmetic Product WO 4081-1|Application of the product on the pre-defined skin area on the forearms twice daily for four weeks
15902609|NCT03629392|Behavioral|Low met/cys diet|Dietary intervention with low contents of methionine and cysteine
15902610|NCT03629392|Behavioral|Moderate met/cys diet|Dietary intervention with moderate contents of methionine and cysteine
15902611|NCT03629392|Behavioral|High met/cys diet|Dietary intervention with high contents of methionine and cysteine
15922625|NCT03477110|Drug|Temozolomide|Given PO
15902612|NCT03629379|Drug|Ustekinumab|Patients will receive standard dosing of ustekinumab with a single intravenous infusion of about 6mg/kg ustekinumab at week 0, followed by ustekinumab 90mg subcutaneously every 8 weeks.
15902613|NCT03629379|Drug|Vedolizumab|Patients will receive standard dosing of vedolizumab 300mg at weeks 0, 2, 6, and 14. Patients with Crohn's disease could receive an extra infusion at week 10.
15902614|NCT03629366|Behavioral|Supported Employment (SE)|Supported Employment
15902615|NCT03629366|Behavioral|Treatment as usual (TAU)|Treatment as usual
15902616|NCT03629353|Procedure|endotracheal intubation|After preoxygenation with FiO2 1.0 and flow rate of 8 L/min for 3 minutes, the enrolled patients will be intubated with endotracheal tube and maintained oxygenation during surgery.
15902617|NCT03629353|Procedure|high flow nasal cannula|After preoxygenation with 100% oxygen through high flow nasal cannula for 3 minutes, the enrolled patients will be maintained intubationless oxygenation with flow rate of 70 L/min during surgery.
15902618|NCT03629340|Drug|Metformin|500 mg PO BID x 1 week then increase to 1000 mg PO BID x 11 weeks
15902619|NCT03629340|Drug|Placebo oral capsule|Placebo capsule that is of identical size, shape, and color to experimental drug capsule PO (by mouth) BID (two times each day) for 12 weeks
15902620|NCT03629327|Drug|ASA 81mg|Participants will be randomized to take 81mg orally on a daily basis for a duration of 6 months
15902621|NCT03629327|Other|Control Group|Participants will be randomized to take nothing on a daily basis for a duration of 6 months
15902622|NCT03629327|Drug|ASA 325mg|Participants will be randomized to take 325mg orally on a daily basis for a duration of 6 months
15902624|NCT03629301|Behavioral|ID-DPP group|This group will receive a 6 month long online behavioral change protocol adapted from the Diabetes Prevention Program. It includes 18 sessions, 12 delivered weekly (during the first 3 months) and 6 delivered biweekly (during the last 3 month period). A web page will be used to deliver the sessions, while the nutritional counseling will be delivered using video calls via Facebook chat. Participants will receive an hypocaloric (1200-1800 kcal, carbohydrates: 45-65%, fats: 20-35% and protein: 10-35%), personalized diet.
15902625|NCT03629301|Other|Wait-list Group|This group will only receive written information with recommendations on healthy eating. When the study has finished this group will receive a behavioral change protocol with nutritional counseling using a face-to-face format.
15902626|NCT03629288|Other|Lactose tab|Tablet containing lactose Procedure: Periodontal treatment Scaling and root planning
15902627|NCT03629288|Drug|Azithromycin|Tablet containing 500mg Azithromicyn. Procedure: Periodontal treatment Scaling and root planning
15902628|NCT03629275|Combination Product|CTX0E03 Drug Product and delivery device|Includes stereotactic surgery and a burr hole drilled through the skull to allow for a one time intracerebral injection of 20 million CTX0E03 Drug Product stem cells into an area of the brain adjacent to the area affected by the stroke.
15902629|NCT03629275|Drug|Placebo|Sham surgical comparator includes stereotactic surgery and a partial thickness burr hole drilled into the skull. No injection of any kind is made into the brain, and no other intervention is given.
15902630|NCT03629262|Drug|Dexmedetomidine|Patients in this group receive patient-controlled intravenous analgesia for 1-3 days after surgery. The formula is a mixture of dexmedetomidine (1.25 ug/ml) and sufentanil (1.25 ug/ml), diluted with normal saline to 160 ml. 5-HT3 receptor antagonist is added when necessary. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with a bolus dose of 2 ml at each time and a lockout interval of 8 minutes.
15902631|NCT03629262|Drug|Placebo|Patients in this group receive patient-controlled intravenous analgesia for 1-3 days after surgery. The formula is a mixture of placebo and sufentanil (1.25 ug/m), diluted with normal saline to 160 ml. 5-HT3 receptor antagonist is added when necessary. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with a bolus dose of 2 ml at each time and a lockout interval of 8 minutes.
15902632|NCT03629249|Drug|Placebo once daily|Placebo to QAW039 once daily (one tablet blinded placebo to QAW039 150 mg and one tablet blinded placebo to QAW039 450 mg).
15902633|NCT03629249|Drug|QAW039 150 mg once daily|QAW039 150 mg once daily (one tablet of blinded QAW039 150 mg to be given together with one tablet blinded placebo to QAW039 450 mg)
15902634|NCT03629249|Drug|QAW039 450 mg once daily|QAW039 450 mg once daily (one tablet of blinded QAW039 450 mg to be given together with one tablet blinded placebo to QAW039 150 mg)
15902635|NCT03629236|Other|GrafixPL|Debridement, GrafixPL application, dressing application, standard compression therapy
15902636|NCT03629236|Other|Control|Debridement, dressing application, standard compression therapy
15902637|NCT03629223|Drug|Tepotinib TF2|Participants will receive single oral dose of Tepotinib TF2 under fasting or fed conditions in treatment period 1 or 2.
15902638|NCT03629223|Drug|Tepotinib TF3|Participants will receive single oral dose of Tepotinib TF3 under fasting or fed conditions in treatment period 1 or 2.
15902639|NCT03629210|Drug|OZURDEX|OZURDEX® (DEX implant, 0.7 mg) is a micro-ionized and non-preserved dexamethasone within a cylindrically-shaped 0.45 mm diameter x 6.5 mm length biodegradable Poly D, L-lactate-co-glycolic acid pellet allowing for sustained delivery dexamethasone into the vitreous cavity and retina following intravitreal injection. Health Canada has granted approval for use of DEX implant in the treatment of ME following central retinal vein occlusion, non-infectious uveitis affecting the posterior segment and pseudophakic DME in adult patients. (OZURDEX® Canadian Product Monograph, April 14, 2015). DEX implant will be provided as investigational treatment by Allergan Inc., Markham, ON, Canada.
15902640|NCT03629210|Biological|Eylea|EYLEA® (AFL 2.0 mg intravitreal injections) is an anti-VEGF treatment. AFL (2.0 mg) has received approval from Health Canada for the treatment of DME. Health Canada has also granted approval for AFL (2.0 mg) in the treatment of age-related macular degeneration, and ME secondary to retinal vein occlusion.
15902641|NCT03629197|Behavioral|Communication skills training|Intervention components include an 8-10 minute instructional video, a pocket card and pamphlet, and 2 standardized patient visits with role-play and feedback by the standardized patient
15902642|NCT03629197|Other|Attention control|Physician will review materials based on CDC opioid prescribing guidelines.
15902876|NCT03627273|Diagnostic Test|6 minutes walking test with walker|to walk during 6 minutes with walker
15922626|NCT03477110|Radiation|Radiation Therapy|Undergo radiation therapy
15902643|NCT03629184|Drug|Baloxavir Marboxil|"Baloxavir marboxil will be administered as oral suspension in a single dose on Day 1.
~Oseltamivir matching placebo will also be administered as oral suspension twice daily (BID) for 5 days."
15902644|NCT03629184|Drug|Oseltamivir|Oseltamivir will be administered as oral suspension BID for 5 days. Participants receiving oseltamivir will also receive baloxavir marboxil matching placebo as oral suspension, single dose on Day 1.
15902645|NCT03629171|Drug|Liposome-encapsulated Daunorubicin-Cytarabine|Given IV
15902646|NCT03629171|Drug|Venetoclax|Given PO
15902647|NCT03629158|Behavioral|CLIMB intervention|"The intervention group will receive the Cardiac Lifestyle Intervention for Maintaining healthy Behaviors (CLIMB) intervention. Participants will participate in a 3-session, one-on-one intervention that takes place over the course of two weeks. Sessions range from 1-2 hours in length, including questionnaire completion. Participants will be given information and taught relevant skills to increase engagement in lifestyle behaviors relevant to cardiac health."
15902648|NCT03629145|Behavioral|Live Music Therapy|Investigator will begin play live guitar and voice music.
15902649|NCT03629145|Behavioral|Recorded Music Therapy|Investigator will play recorded music.
15902650|NCT03629132|Procedure|Platelet-rich plasma|Platelet-rich plasma intrauterine injection
15902651|NCT03629132|Procedure|gel|Self-crosslinking sodium hyaluronate gel intrauterine injection
15902652|NCT03629119|Dietary Supplement|Dietary Fiber Supplement|Participants will be instructed to consume 1 tea spoon of psyllium per day for 3 months and otherwise maintain their habitual diet. Participants will be asked to keep a diary assessing bowel movement and intestinal symptoms such as bloating and flatulence beginning two weeks prior to the intervention.
15902653|NCT03629106|Behavioral|Weekly Behavioral Coaching Session|The participants will be provided with a 20-minute individual behavioral support session weekly for 4 weeks (28 days abstinence), designed to provide them with tools and techniques to manage the craving and withdrawal symptoms that occur with cessation.
15902654|NCT03629093|Drug|General Anesthetics|General anesthesia required for surgery procedures or diagnostic interventions using either intravenous or inhalation anesthetics, or both.
15902655|NCT03629080|Biological|HB-101 vaccine|HB-101 is a bivalent vaccine that contains two replication deficient recombinant lymphocytic choriomeningitis virus (rLCMV) vectors expressing pp65 and a truncated isoform of gB of human CMV.
15902656|NCT03629080|Biological|placebo|Saline will be used for placebo.
15902657|NCT03629067|Drug|Treatment T|Fixed dose Combination of Fimasartan/Amlodipine/Hydrochlorothiazide
15902658|NCT03629067|Drug|Treatment R|Co-administration of Fimasartan/Amlodipine and Hydrochlorothiazide
15902659|NCT03629054|Drug|Empagliflozin, Metformin HCl, Linagliptin (fixed dose combination)|single dose
15902660|NCT03629054|Drug|Empagliflozin|single dose
15902661|NCT03629054|Drug|Linagliptin|single dose
15902662|NCT03629054|Drug|Metformin HCl|single dose
15902663|NCT03629041|Device|Microneedle Patch|At the first visit participants will have either the buccal or palatal treated. At the second visit the other area will be treated.
15902664|NCT03629041|Device|Patch with no microneedles|At the first visit participants will have either the buccal or palatal treated. At the second visit the other area will be treated.
15902665|NCT03629028|Diagnostic Test|Residual myometrium thickness|The myometrium will be closed by single or double layer during cesarean and residual myometrium thickness will be evaluated in 6 to 9 months by saline infusion sonography.
15902666|NCT03629028|Diagnostic Test|Niche Presence|The myometrium will be closed by single or double layer during cesarean and niche presence will be evaluated in 6 to 9 months by saline infusion sonography.
15902667|NCT03629028|Diagnostic Test|Adjacent myometrium thickness|The myometrium will be closed by single or double layer during cesarean and adjacent myometrium thickness will be evaluated in 6 to 9 months by saline infusion sonography.
15902668|NCT03629028|Diagnostic Test|Niche Measurements (depth of niche, width of niche, length of niche)|The myometrium will be closed by single or double layer during cesarean and three dimensional niche measurements will be evaluated in 6 to 9 months by saline infusion sonography.
15902669|NCT03629015|Biological|Stemchymal®|ALF/ ACLF patients will receive Stemchymal® through intravenous infusion
15902670|NCT03629002|Biological|Study of the gene expression profile|qPCR analysis
15902671|NCT03628989|Behavioral|Use of Virtual Technology|If parent and child consent to be in the study, the clinician will offer the use of one of the technologies: Virtual Reality (VR) headset or Augmented Reality (AR) headset. Active content includes video games, interactive avatars, and interactive experiences, while passive content includes video clips and movies. All patients will be offered the opportunity to use these technologies during their minor procedures if they meet eligibility criteria. Those who decline or who are switched over to the standard of care due to patient preference, health providers monitoring and assessment during the procedure will be noted in the database.
15902672|NCT03628976|Other|tVNS|Intervention
15902673|NCT03628963|Device|Concerto+|a user-centered, multifunctional and personalized eHealth platform
15902674|NCT03628950|Procedure|ICSSB group|At supine position with abducted limb, the probe of ultrasound will be translocated in costoclavicular space; the subclavian artery will be identified. The three cords of the brachial plexus will be visualized lateral to the artery. By using an in-plane technique and a cephalad-to-caudate direction, the block needle will be advanced until its tip will be in the middle of three cords and 10 mL of 0.25 % bupivacaine Hydrochloride will be injected. Then at lateral decubitus position, by using in-plane technique the probe will be translocated in suprascapular fossa, lateral-to-medial direction, the block needle will be advanced until its tip in the floor of the suprascapular fossa ventral to the fascia of the supraspinatus muscle and 10 mL of 0.25 % bupivacaine Hydrochloride will be injected .
15902675|NCT03628950|Procedure|ISB group|The probe of ultrasound will be applied in lateral side of the neck at the level of the cricoid cartilage to obtain a view of the three hypoechoic structures which represent the roots of the brachial plexus. Using an in-plane technique and a lateral to-medial direction, the block needle will be advanced until its tip will be positioned under the prevertebral fascia between the two most superficial hypoechoic structures and 10 mL of 0.25 % bupivacaine Hydrochloride will be injected at level of C5-6 and another 10 ml of 0.25 % bupivacaine Hydrochloride will be injected at level of C7-8.
15902877|NCT03627273|Diagnostic Test|6 minutes walking test|to walk during 6 minutes with walker
15902676|NCT03628937|Dietary Supplement|Decaffeinated Green Tea Polyphenol|Intervention group will be given decaffeinated green tea polyphenol capsules (400 mg, EGCG accounted for 50%). Participants need take it once a day after breakfast for 12 weeks.
15902677|NCT03628937|Other|Placebo control|The starch capsule was used as a placebo control, which has the same dosage, appearance and smell compared to decaffeinated green tea polyphenol capsule. The use frequency and duration are consistent with intervention group.
15902678|NCT03628924|Drug|Guselkumab dose 1|Participants will receive guselkumab dose 1 IV.
15902679|NCT03628924|Drug|Guselkumab dose 2|Participants will receive guselkumab dose 2 SC in Group 1, 2 and Group 3.
15902680|NCT03628924|Drug|Guselkumab dose 3|Participants will receive guselkumab dose 3 SC in Group 3.
15902681|NCT03628924|Drug|Placebo|Participants will receive matched placebo SC and IV in group 1, 2 and 3 with an additional placebo SC dose in Group 3.
15902682|NCT03628911|Device|Tetanizing Burst Therapy|Tetanizing Burst Therapy tetanizes skeletal muscle with a brief burst of stimulation prior to ICD shock, thereby reducing muscular contraction due to the shock
15902683|NCT03628898|Device|INVSENSOR00025|Noninvasive pulse oximeter sensor
15902684|NCT03628885|Behavioral|Top Concern Tailored Intervention|General Vaccine Information video plus a brief (< 50 sec) animated video address the parent's top ranked question or concern from the provided list of possible concerns.
15902685|NCT03628885|Behavioral|All Concerns Tailored Intervention|General Vaccine Information video plus one or more brief (< 50 sec) animated videos that address all of the parent's indicated question or concern from the provided list of possible concerns.
15902686|NCT03628872|Procedure|Scaling and root planing|"A non-surgical procedure that treats periodontal disease, sometimes called a deep cleaning, is considered the gold standard (standard of care) of treatment for patients with chronic periodontitis."
15902687|NCT03628872|Device|Er:YAG Laser|This laser is intended to be used for dental surgery. The Er:YAG Laser emits an infrared beam which is readily absorbed by water contained by both hard and soft tissues of the human body. As a result, energy of the laser beam instantly vaporizes the water molecules in soft and hard tissues of the tooth and surrounding tissues causing the tissues to crumble away or resection of the soft tissues of gingival.
15902688|NCT03628872|Device|Hand instruments|11/12 and 13/14 gracey, 4R/4L curette and sickle - standard of care choices for performing scaling and root planing.
15902689|NCT03628859|Biological|Immunological and tumour characterization|FFPE, blood samples (liquid biopsy, heparin and EDTA blood) performed in patients presenting a renal metastatic cancer receiving treatment as standard practice according to physician's choice (2nd or 3rd line of treatment with nivolumab, everolimus, axitinib or cabozantinib [in France only], as per product SmPC or 1st line treatment with sunitinib or pazopanib or receiving 2nd or 3rd line of treatment with nivolumab)
15902690|NCT03628833|Device|Incontinence Management System|Incontinence detection device
15902691|NCT03628820|Behavioral|Dog Therapy|5 minutes spent with therapy dog during shift
15902692|NCT03628820|Behavioral|Coloring|5 minutes spend coloring mandalas during shift
15902693|NCT03628794|Device|D-SCAN|"Subjects will receive a digital patient navigator service in the form of a mobile application (app), which has been designed at Duke, with feedback from Duke Cancer Institute (DCI) patients, caregivers and clinicians. Its purpose is to facilitate awareness of available Cancer Patient Support Program (CPSP) services at Duke, and to also help patients recognize their unmet symptom management needs. Subjects receiving the D-SCAN mobile app will also complete a survey every week within the app. The first 15 patients and 5 caregivers randomized into the intervention arm (those receiving the app) will also be asked to participate in a qualitative interview assessment at week 12, +/- 3 weeks"
15902694|NCT03628781|Other|Behavioral tools integrated within mehealth for ADHD software|Integrated functionality within the mehealth for ADHD software allows parents and teachers to set up and deliver behavioral interventions such as daily report card systems and home-based program such as star charts. Automated wizards lead parents and teachers through the process of selecting target behaviors and setting up reward schedules. Baseline data is gathered online and algorithms derive a set of behavioral goals for the child. Thereafter, parents or teachers record the child's performance directly into the software. Once behavioral monitoring begins, parents and teachers receive daily email or text communications from mehealth for ADHD alerting them to the daily rewards earned by their child. Finally, online algorithms exist that detect how a child is doing in meeting behavioral goals and prompt users to modify goals accordingly.
15902695|NCT03628781|Other|mehealth for ADHD|"The mehealth for ADHD software has multiple functionalities including 1) online training regarding the American Academy of Pediatrics (AAP) ADHD guidelines; 2) an ADHD workflow wizard that guides pediatricians through the creation of an efficient office workflow to deliver quality ADHD care; 3) online collection of parent- and teacher-report ADHD rating scales for the assessment of ADHD as well as monitoring response to medication treatment; 4) integrated algorithms that automatically score rating scales in real time and provide pediatricians with assessment and treatment reports as well as immediate warnings; 5) a communication feature that allows parents, teachers, and pediatricians to communicate with each other; 6) an online pediatrician report card; and 7) a Plan-Do-Study-Act wizard that allows pediatricians to select a practice behavior to improve based on their report card and guides them through the creation of small tests of change to improve their office systems."
15902696|NCT03628768|Other|Data collection|telephone interview questionnaire, in-home face-to-face interview, and data from the Collection Site
15902697|NCT03628755|Behavioral|Digital Manipulation of Thyroid cartilage|"Digital manipulation of thyroid cartilage was applied to the anterior aspect of thyroid cartilage while using the thumb or finger and the patient was asked to speak.
~prolongation of vowel is 7 to 8 seconds, voice rest after each set is 10 second.
~total repetition is 60."
15902698|NCT03628755|Behavioral|Fluency Shaping Therapy|FST session comprised of speech techniques such as prolongation of sounds, easy onset, continuous phonation, light articulatory contact, in reading and conversation in three speaking situations (speaking with therapist, reading aloud, and free conversation Reading task was for 80 short phrases.
15902699|NCT03628755|Behavioral|combination Group|combination group intervention of DMT + FST
15902878|NCT03627260|Behavioral|Fill up a handful of sunscreen and spread it all over your body. Sunscreen, Actinica|"Volunteers were asked to follow the rule of thumb: Fill up a handful of sunscreen and spread it all over your body."
15903378|NCT03623230|Drug|Bupivacaine 0.125% Injectable Solution|Perineural Injection
15902700|NCT03628729|Other|Embrace™ WetBond™ Pit & Fissure Sealant|pit and fissure sealant that contain the precursor in the formation of hydroxyapatite which is Amorphous Calcium Phosphate (ACP) ,which has anti-cariogenic effect as well as remineralization potential as it contain bioactive material which stimulate crystal growth within the lesion by increasing the concentration of calcium and phosphate ions
15902701|NCT03628729|Other|Seal-Rite™ Pit & Fissure Sealant, Pulpdent Corportation, USA|Fluoride releasing resin based pits and fissures sealant
15902702|NCT03628716|Biological|CV301|"Prime with MVA-BN-CV301 (nominal titer 1.6 x 10^9 Inf.U) given subcutaneously (SC) on Day 1 and Day 22. One dose = four 0.5 mL injections. One injection = nominal titer 4 x 10^8 Inf.U in 0.5 mL.
~Boost with FPV-CV301 (nominal titer of 1 × 10^9 Inf.U in 0.5 mL, given SC every 21 days for 4 doses (on days 43, 64, 85, and 106), followed by boosts every 6 weeks until 6 months on trial (i.e., days 148 and 190), then every 12 weeks until completion of 2 years. One dose = one 0.5 mL injection."
15902703|NCT03628716|Biological|Atezolizumab|Atezolizumab fixed dose of 1200 mg intravenous on Day 1 of each 21-day cycle
15902704|NCT03628703|Device|Repetitive TMS|Repetitive Intermittent Theta-Burst Transcranial Magnetic Stimulation over the right Pre-supplementary Motor Area
15902705|NCT03628690|Device|BandGrip|Topical skin closure device
15902706|NCT03628690|Device|Suture|Wound closure
15902709|NCT03628664|Radiation|CT scan|Assessment of the actual posterior condylar angle using the CT scan
15902710|NCT03628651|Other|Blood Sample Collection|HCC subjects will have one blood sample collected.
15902711|NCT03628651|Other|Blood Sample Collection|Surveillance subjects will have a blood sample collected and will be followed for up to 6 months. A second blood sample will be collected at the 6 month visit which will be scheduled no longer than 6 months from enrollment.
15902712|NCT03628638|Other|Blood Sample Collection|Subjects participating in the study will have blood sample collected at enrollment. . For any subjects scheduled for a 12 month follow-up, additional blood samples will be collected at 12 months from enrollment.
15902713|NCT03628625|Drug|Letrozole 2.5mg|total dose 7.5 mg per day for 3 days
15902714|NCT03628625|Drug|Placebo|Folic acid for 3 days
15902715|NCT03628625|Drug|Misoprostol|Misoprosrol 800mcg will be given to all patients for induction of abortion
15902716|NCT03628612|Biological|AUTO CAR T cell therapy|No study drug is administered in this study. Patients previously treated with AUTO CAR T cell therapy will be monitored for safety following the first infusion.
15902717|NCT03628599|Device|Delefilcon A contact lenses|Water Gradient silicon hydrogel daily disposable contact lenses
15902718|NCT03628599|Device|Senofilcon A contact lenses|Silicon hydrogel daily disposable contact lenses with HydraLuxe™ Technology
15902719|NCT03628573|Device|repetitive transcranial magnetic stimulation (MagPro X100).|accelerated rTMS.
15902720|NCT03628573|Device|Intermittent Theta burst stimulation ( iTBS)|
15902721|NCT03628560|Device|RespirAct Step-Wise Normocapnia desaturation sequence|Blood carbon dioxide controlled at normal value (normocapnia).
15902722|NCT03628560|Device|RespirAct Slope Normocapnia desaturation sequence|Blood carbon dioxide controlled at normal value (normocapnia).
15902723|NCT03628560|Device|RespirAct Step-Wise Hypocapnia desaturation sequence|Blood carbon dioxide controlled at lower than normal value (hypocapnia).
15902724|NCT03628560|Device|RespirAct Slope Hypocapnia desaturation sequence|Blood carbon dioxide controlled at lower than normal value (hypocapnia).
15902725|NCT03628560|Device|ROBD Step-Wise desaturation sequence|Blood carbon dioxide is controlled at normal or lower value by subject's own breathing rate.
15902726|NCT03628547|Behavioral|Measuring devices and questionnaires|Measuring devices and questionnaires will be applied to assess the pain and psychosocial states of musculoskeletal system of athletes. The Expanded Scandinavian Muscle Skeleton Questionnaire (NMQ) and Visible Analogue Scale (VAS) will be used to identify and assess the symptoms of musculoskeletal discomfort as 'pain'. The participant will be evaluated with the algometer, the sporty trust will be questioned with the Sporty Trust Continuous Inventory, and the Quality of Life will be assessed with the World Health Organization Quality of Life Scale Short Form and Depression will be evaluated with Beck Depression Inventory.
15902727|NCT03628534|Device|Saline Enhanced Radiofrequency (SERF) ablation|Ablation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter
15902728|NCT03628521|Drug|Anlotinib，Erlotinib，IBI308，Pemetrexed，gemcitabine，carboplatin|Patient harboring EGFR mutation will be enrolled into arm A. Patients without sensitive EGFR mutation will be assigned to either arm B or arm C based on patients' or treating physicians'choice
15902729|NCT03628508|Other|Exercise|Comprehensive exercise program including strengthening, stretching, gait modification etc.
15902730|NCT03628495|Device|compression|compression will be delivered using compression garment
15902731|NCT03628495|Device|occlusion|occlusion will be delivered using silicone gel sheeting
15902732|NCT03628482|Procedure|CRF|For continuous radiofrequency ablation the electrode tip temperature was raised to 80°C during 90 s.
15902733|NCT03628482|Procedure|PRF|The procedure for PRF is almost identical to that applied for CRF, except that the current is typically carried out in 20 ms pulses every 0.5 s at a temperature that does not exceed 42 °C during 360 s.
15902734|NCT03628469|Behavioral|Proactive Health Support|Active listening, coaching and counselling
15902735|NCT03628456|Device|International Biophysics AffloVest|High-frequency chest wall oscillation vest
15902736|NCT03628456|Device|Hill-Rom Monarch|High-frequency chest wall oscillation vest
15902737|NCT03628443|Diagnostic Test|Fibroblast Growth Factor 23|A sample of blood is tested for levels of fibroblast growth factor 23
15902738|NCT03628430|Procedure|lidocaine with epinephrine|Local anesthesia with lidocaine with epinephrine
15902739|NCT03628430|Procedure|sodium bicarbonate|sodium bicarbonate as adjuvant to lidocaine with epinephrine in Local anesthesia
15902740|NCT03628430|Procedure|Normal saline|normal saline as adjuvant to lidocaine with epinephrine in Local anesthesia
15902950|NCT03626753|Drug|"(Piroxicam piroxan) 20Mg/1mL Injection"|"2 ampoules of (piroxicam piroxan) administrated intravenously once per 24 hours."
15902741|NCT03628417|Procedure|Calcium Electroporation|"If the patient agrees biopsies will be performed from the tumor area before and after electroporation during local anaesthesia. Maximum of 8 biopsies will be done, depending on the patient's number of metastases.
~All patient's regardless of the number of metastases will have one biopsy from area treated with calcium and one from area treated with bleomycin, after the randomization code is revealed at day 180.
~Patients with more than 6 metastases: One to two biopsies before treatment, one to two biopsies one week after treatment from metastases treated with calcium and bleomycin respectively.
~All biopsies will be handled according to current guidelines and analyzed by a pathologist for amount of tumor tissue, inflammation, fibrosis and necrosis."
15902742|NCT03628417|Procedure|Bleomycin based electrochemotherapy|"If the patient agrees biopsies will be performed from the tumor area before and after electroporation during local anaesthesia. Maximum of 8 biopsies will be done, depending on the patient's number of metastases.
~All patient's regardless of the number of metastases will have one biopsy from area treated with calcium and one from area treated with bleomycin, after the randomization code is revealed at day 180.
~Patients with more than 6 metastases: One to two biopsies before treatment, one to two biopsies one week after treatment from metastases treated with calcium and bleomycin respectively.
~All biopsies will be handled according to current guidelines and analyzed by a pathologist for amount of tumor tissue, inflammation, fibrosis and necrosis."
15902743|NCT03628391|Drug|Haloperidol|haloperidol for ICU delirium, titrated on validated screening tool-based diagnosis
15902744|NCT03628391|Drug|Placebo|placebo for ICU delirium, titrated on validated screening tool-based diagnosis
15902745|NCT03628378|Device|Verasense|Ligamentous balancing device
15902746|NCT03628365|Dietary Supplement|HMB (beta-hydroxy beta-methylbutyrate)|1.5 g, b.i.d., by the enteral route, from Day 4 to Day 30 (minimum 10 days)
15902747|NCT03628352|Drug|Tricaprilin|Tricaprilin with flavoring agents added
15902748|NCT03628339|Drug|Midazolam|Participant will receive single oral dose of midazolam on Day 1 of treatment period 1 and co-administration of tepotinib and midazolam on Day 11 of treatment period 2.
15902749|NCT03628339|Drug|Tepotinib|Participants will receive single oral dose of tepotinib for 10 days in treatment period 2.
15902750|NCT03628326|Other|Pulmonary arterial tree|The investigators performed 3D reconstruction of the pulmonary arterial tree on the CT angiography data set acquired during preoperative work-up.
15902751|NCT03628313|Other|Transthoracic ultrasound|Patients are prospectively identified during echocardiography performed in the echocardiography laboratory of the two participating centers when a diagnosis of aortic stenosis is made.
15902752|NCT03628300|Other|piperacillin serum concentration monitoring|initiation of a continuous piperacillin infusion at the standard dose and who underwent piperacillin serum concentration monitoring.
15902753|NCT03628287|Other|Revised Care Coordination Program|Greater focusing, tailoring and cues for delivery of key components of Care Coordination
15902754|NCT03628287|Other|Original Care Coordination Program|Original Care Coordination
15902755|NCT03628274|Device|Magnetic Resonance Imaging (MRI) 7 Tesla|An MRI performed as part of the project
15902756|NCT03628274|Device|Magnetic Resonance Imaging (MRI) 1,5 Tesla|An MRI performed as part of the care
15902757|NCT03628261|Device|Serious Game|Surface EMG detection for the myoelectric control of the EMG-based serious games and for the EMG assessment during gait will be performed with a wireless system.This device is composed of seven modules (sensor units), each detecting and transmitting two bipolar EMGs at 2 kilo Hertz (kHz). During the evaluation protocol EMGs will be detected from peroneus longus, gastrocnemius medialis, soleus and tibialis anterior muscles of both limbs using pre-gelled electrodes.
15902758|NCT03628261|Other|physical therapy|Children receive the regular rehabilitation for the treatment of ankle plantar flexor muscle overactivity and the paresis of ankle dorsal flexor muscle
15902759|NCT03628248|Procedure|embolization of the inferior mesenteric artery|proximal occlusion of the inferior mesenteric artery, before its divisional branches, by coils or plug 3-4 weeks prior to surgery.
15902760|NCT03628248|Procedure|Inferior mesenteric artery ligation|Endovascular ligation of Inferior mesenteric artery
15902762|NCT03628222|Device|ENB-TBLB|"ENB Guidance: The iLungTM SuperNavigator system will be used, it comprises of iLungTM ENB system, location catheter and guide catheter. The guide catheter can supply a 1.9 mm working channel for biopsy tools.
~The location catheter is inserted into the guide catheter beforehand, then both are introduced via the working channel of the bronchoscope. Under guidance of ENB system, the location catheter reaches the lesion, and actual distance is confirmed by the X-ray.
~TBLB: Location catheter is retracted, then the biopsy forceps and brush was introduced, and pathologic specimens are obtained."
15902763|NCT03628222|Device|X-ray-TBLB|Based on chest CT, the physician determines the lesion location. Under X-ray guidance, via the bronchoscope's working channel, the biopsy forceps and brush are introduced and pathologic specimens are obtained.
15902764|NCT03628209|Drug|Nivolumab|Participants will be treated with Nivolumab intravenously (IV), 3 mg/kg on days 1 and 15 of each cycle.
15902765|NCT03628209|Drug|Azacitidine|Phase I Dose Escalation - Dose level 1: NA. Dose level 2: 60 mg/m^2. Dose level 3: 75 mg/m^2. Phase II Expansion - Treated at recommended Phase II dose (RP2D).
15902766|NCT03628209|Procedure|Post Treatment Surgery|Resection surgery at end of Cycle 1 treatment, day 28-35.
15902767|NCT03628183|Other|Hydrolysate Infant Formula 1|Feed ad lib
15902768|NCT03628183|Other|Hydrolysate Infant Formula 2|Feed ad lib
15902769|NCT03628170|Other|platelet rich fibrin|platelet rich fibrin will be prepared from patient's venous blood and inserted in the centrifuge at 2000 r.p.m. for 12 minutes Then, the Platelet rich fibrin plug will be placed in the socket after extraction for socket preservation covered by platelet rich fibrin membrane.
15902770|NCT03628170|Other|Free gingival graft|Free gingival graft will be taken from the palate to cover the socket after extraction of the tooth for socket preservation.
15902771|NCT03628157|Other|Geistlich Bio-Oss® bovine bone alone|Ridge augmentation by titanium reinforced polytetraflouroethelene membrane and anorganic bovine bone derived mineral alone
15902917|NCT03626935|Device|3D-printed customized guide plate|3D-printed customized guide plate will be used in the ankle arthrodesis to help reduce operation time and reduce intra-operative radiation.
15922944|NCT03474458|Drug|Standard of care therapy|Standard of care therapy
15902772|NCT03628144|Dietary Supplement|Impact® Advanced Recovery|The intervention drink Impact® will be ingested every two weeks since usually chemotherapy is delivered concurrently with radiation therapy in 2 week cycles. For patients who are placed on weekly or every 4 weeks chemotherapy dosing schedules, the treatment and control supplements will still be given every two weeks.
15902773|NCT03628144|Dietary Supplement|Boost® High Protein|The control supplement drink Boost® will be ingested every two weeks since usually chemotherapy is delivered concurrently with radiation therapy in 2 week cycles. For patients who are placed on weekly or every 4 weeks chemotherapy dosing schedules, the treatment and control supplements will still be given every two weeks.
15902774|NCT03628144|Radiation|Radiation Therapy|Standard of Care: Weekly radiation therapy as already planned for each participant, at Moffitt clinic visits.
15902775|NCT03628144|Drug|Chemotherapy|Standard of Care: Chemotherapy as already planned for each participant.
15902776|NCT03628144|Other|Quality of life (EORTC-QLQ-30)|Participants will undergo pre- and post-treatment assessments.
15902777|NCT03628144|Other|Evaluation of Cognitive Function (FACT-Cog, v. 3.0)|Participants will undergo pre- and post-treatment assessments.
15902778|NCT03628144|Other|Mindfulness Questionnaire (FFMQ)|Participants will undergo pre- and post-treatment assessments.
15902779|NCT03628131|Drug|Pazopanib|Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
15902780|NCT03628131|Drug|Ifosfamide|Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
15902781|NCT03628131|Drug|Carboplatin|Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
15902782|NCT03628131|Drug|Etoposide|Conventional chemotherapy (Ifosfamide, carboplatin, etoposide) with Pazopanib
15902783|NCT03628105|Behavioral|CR Before Exposure|"Participants complete 15 minutes of CR (Preparation) using the evidence technique outlined in the cognitive-behavioral manual Mind Over Mood (Greenberger & Padesky, 2016). This technique involves evaluating the validity of expected feared outcomes. Next, participants complete six 5-minute exposure trials using a claustrophobic chamber and other materials (e.g., scarf, mask, handcuffs). Finally, participants complete the 15-minute self-report filler task (including questions from the MMPI-2, Butcher et al., 1989) which acts as a no-treatment comparison to CR being conducted after exposure in the other arm of the study."
15902784|NCT03628105|Behavioral|CR After Exposure|Participants complete the 15-minute self-report filler task (including questions from the MMPI-2, Butcher et al., 1989) which acts as a no-treatment comparison to CR being conducted before exposure in the other arm of the study. Next, participants complete six 5-minute exposure trials using a claustrophobic chamber and other materials (e.g., scarf, mask, handcuffs). Then, participants complete 15 minutes of CR (Consolidation, Craske et al.'s, 2014) by calculating the difference between predicted and actual expected feared outcomes, and identifying identify (1) whether they believe their feared outcomes occurred (Yes/No), (2) describe how they know this to be true, and (3) reflect on what they learned about their feared outcome or expectancy through exposure.
15902785|NCT03628092|Device|CO2 Fractional Ablative Laser|Vaginal / vulval laser treatment
15902786|NCT03628092|Device|Placebo|Sham Device
15902787|NCT03628079|Drug|ReposMBZ|Capsules 50mg, 100mg, 200mg
15902788|NCT03628066|Drug|Letrozole|Letrozole 2.5 mg by mouth daily for 24 weeks
15902789|NCT03628066|Drug|Palbociclib|Palbociclib 125mg by mouth daily for 21 days per 28-day cycle (21 days on, 7 days off) for 24 weeks
15902790|NCT03628066|Drug|Goserelin|Goserelin 3.6mg subcutaneous injection x 1 on Day 1 of each 28-day cycle for 24 weeks
15902791|NCT03628066|Diagnostic Test|Oncotype DX Breast Recurrence Score|Prior to assignment to Arm 1 the Oncotype DX diagnostic test will be conducted on diagnostic tissue to assign a recurrence score for stratification to cohort 1 or 2.
15902792|NCT03628053|Biological|Tisagenlecleucel|autologous cellular immunotherapy product
15902793|NCT03628053|Drug|Blinatumomab|bispecific CD19-directed CD3 T-cell engager
15902794|NCT03628053|Drug|Inotuzumab|CD22-directed antibody-drug conjugate
15902795|NCT03628040|Drug|Ropivacaine Injection [Naropin]|Ropivacaine will be injected in the erector spinae plane
15902796|NCT03628040|Drug|Normal saline|Normal saline will be injected in the erector spinae plane
15902797|NCT03628027|Device|Computerised decision support algorithm|The algorithm is integrated into the EMIS computer system used by GPs. The algorithm advises on which antidepressants should be prescribed based on a patient's treatment history.
15902798|NCT03628014|Other|Inpatient-care program|"Patients enrolled in the Hospital Elder Life Program can receive four types of personalized volunteer-led interventions based on the needs identified by the care team. These interventions include:
~Daily orientation and visiting program
~Basic active movements
~Meal assistance
~Recreational activities"
15902799|NCT03628001|Procedure|ERCP|Pts will be randomized with or without sphinterectomy.
15902800|NCT03627988|Other|Patients with invasive breast cancer will receive:|"Total mastectomy with Immediate prosthetic breast reconstruction
~Adjuvant therapy by TomoTherapy (radiation therapy alone or preceded by chemotherapy)."
15902801|NCT03627975|Procedure|Conservative treatment|"The conservative treatment of hemorrhagic moyamoya disease mainly includes the control of hypertension, prevention and treatment of secondary epilepsy, the control of intracranial hypertension, and the corresponding symptomatic and neurotrophic treatment.
~In addition to the pharmacotherapy used in conservative treatment, encephalo-duro-arterio-synangiosis(EDAS) will be performed according to the procedures described by Matsushima.
~In addition to the pharmacotherapy used in conservative treatment, the superficial temporal artery(STA) and middle cerebral artery(MCA) by pass surgery is performed. The operation is the modified EDAS which basically similar to EDAS, but the surgical incision is as low as possible. And the STA may not be preserved."
15902802|NCT03627962|Other|gaze-directed oculomotor training|"Device: Tobii PCEye
~Protocol: Visual span was calculated by the distance between human-computer and dpi of fonts. Pointer speed was programmed 120pixels (5 degrees)/1sec for image drift of reading.
~Dosage: 1) gaze-access required 20 to 10 degrees per fixation to activate text-to-speech (TTS) read-aloud function; about 30 repetitions of saccade and fixation.
~2) gaze-directed OMT limited to 10-5 degrees. Chinese characters recognition in multiple choice format, about 60 repetitions.
~Target behavior - gaze-directed access by Tobii PCEye: reading from left to right (=horizontal mouse mover); read-aloud function by gaze dwell > 500ms. To enhance purposeful and repetitive eye movement.
~Frequency: 2 session/wk x 8 wks
~Duration: 30 min/session"
15903991|NCT03618238|Drug|Anlotinib|12 mg daily for continus 14 days every 21 days
15902803|NCT03627949|Behavioral|E-intervention|The intervention will address the basic elements of the HAPA model via the use of behaviour change techniques. In line with Abraham and Michie (2008), we use several behaviour change techniques like providing information about behavioural risk and benefit of behaviour change, prompting intention formation, prompting barrier identification, providing instructions how to perform a behaviour, prompting specific goal setting and review of behavioural goals, providing feedback on performance, prompting practice and providing follow-up prompts, prompting to plan social support and finally prompting relapse prevention, also based on strategies used by other effective computer tailoring programs. Students attended e-health intervention session once a week with about 20 minutes each time.
15902804|NCT03627936|Drug|Lorcaserin manufactured at Zofingen|Lorcaserin XR tablets manufactured at Zofingen.
15902805|NCT03627936|Drug|Lorcaserin manufactured at Kawashima|Lorcaserin XR tablets manufactured at Kawashima.
15902806|NCT03627910|Dietary Supplement|symbiotic|Feed supplementation
15902807|NCT03627910|Dietary Supplement|zinc and arginine|Feed supplementation
15902808|NCT03627897|Drug|Bupivacain|The erector spinae plane blocks proceed with 0,5 ml/kg of 0,25% bupivacain (Group B).
15902809|NCT03627897|Drug|saline|No drugs or interventions were administered to the control group.
15902810|NCT03627884|Drug|Sodium Bicarbonate Catheter Lock Solution|Using Sodium Bicarbonate Catheter Lock Solution
15902811|NCT03627884|Drug|Normal Saline Catheter Lock Solution|Using Sodium Bicarbonate Catheter Lock Solution
15902812|NCT03627871|Behavioral|Majority Norm|Participants receive information about exercise norms that apply to the majority of the population but are given no information about trends in this norm.
15902813|NCT03627871|Behavioral|Trending Minority Norm|Participants receive information about exercise norms that apply to the minority of the population and have recently been trending up.
15902814|NCT03627871|Behavioral|Minority Norm|Participants receive information about exercise norms that apply to the minority of the population but are given no information about trends in this norm.
15902815|NCT03627871|Behavioral|Control|Participants receive information about exercise that is unrelated to social norms or trends in social norms.
15902816|NCT03627871|Behavioral|Trending Majority Norm|Participants receive information about exercise norms that apply to the majority of the population and have recently been trending up.
15902817|NCT03627858|Drug|beclomethasone / formoterol / glycopyrronium|As this is a non-interventional study, all treatment decisions will be made at the discretion of the treating physician prior to enrolment in the study and during the entire period of the study. Treatment will be prescribed according to the product label in the summary of product characteristics.
15902818|NCT03627845|Drug|PHP-303|Investigational drug
15902819|NCT03627845|Other|Placebo|Matching placebo
15902820|NCT03627832|Behavioral|Cognitive Behavioral Therapy for Insomnia (CBT-I)|Participants assigned to the CBT-I condition will attend 1-hour individual sessions of CBT-I once a week for five weeks. Consistent with clinical guidelines (Schutte-Rodin, Broch, Buysse, Dorsey, & Sateia, 2008), treatment will include stimulus control (e.g., limit use of bed to sleep or sexual activity, get out of bed if lying awake for more than 20 minutes), sleep restriction (limit time in bed to amount of time spent sleeping on a typical night), sleep hygiene (e.g., avoid exercise within 2 hours of bedtime, create cool and dark sleep environment), relaxation training, and cognitive restructuring.
15902821|NCT03627832|Behavioral|Sleep Hygiene|All participants will receive a one-page handout on sleep hygiene. This is the only intervention that participants assigned to the Sleep Hygiene condition will receive and is consistent with what may be expected as standard care in a doctor's visit with a primary care physician.
15902822|NCT03627819|Dietary Supplement|Plant sterol-enriched margarine|Margarine enriched with plant sterol esters
15902823|NCT03627819|Dietary Supplement|Plant stanol-enriched margarine|Margarine enriched with plant stanol esters
15902824|NCT03627819|Dietary Supplement|Control margarine|Margarine without any addition
15902825|NCT03627793|Other|resistance training|Moving muscles against loads with the purpose of increasing strength.
15902826|NCT03627780|Diagnostic Test|DNA extraction|DNA will be extracted from white cells
15902827|NCT03627767|Drug|PF-04965842 100 mg|PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 40 weeks
15902828|NCT03627767|Drug|PF-04965842 200 mg|PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 40 weeks
15902829|NCT03627767|Drug|Placebo|Placebo, administered as two tablets to be taken orally once daily for 40 weeks
15902830|NCT03627754|Drug|Glasdegib 100 mg single oral dose|A single dose of 100 mg glasdegib tablet will be administered after an overnight fast, followed by serial PK collection, discharge and follow-up.
15902831|NCT03627741|Drug|Triamcinolone Acetonide|A concentration of 40 mg/ml of Triamcinolone Acetonide will be used for injections with a total dose of 120 mg of Triamcinolone given per injection. The injections will be performed under ultrasound guidance by a fellowship-trained musculoskeletal radiologist. The injection locations will be left to the discretion of the radiologist with the request to attempt to distribute the drug throughout the tumor. A total of three injections will be performed at six week intervals.
15902832|NCT03627728|Drug|Regorafenib|regorafenib/placebo
15902833|NCT03627728|Other|placebo|regorafenib/placebo
15902834|NCT03627715|Drug|Propagermanium|Immediate release capsule
15902835|NCT03627715|Drug|Placebo|Placebo capsule
15902836|NCT03627702|Radiation|Irradiated VIP (Visible Incoherent Polarized)|20 irradiations were performed twice a day. The exposure time was 10 minutes. Exposure was made at a distance of 10 cm.
15902837|NCT03627689|Other|Active air purifier in respiratory allergies/asthma|Continuous use of air purifier to improve allergies and asthma control
15902838|NCT03627689|Other|Sham air purifier|control arm
15902879|NCT03627247|Behavioral|Cognitive Behavioral Stress Management|Interactive activities (e.g., role-playing, use of physical props to introduce concepts related to coping and stress) were designed for each class to optimize participant engagement and understanding of the course material while tailoring class content to the stressors commonly reported by participants. Each week, participants were given coping and relaxation skills to practice at home (e.g., cognitive reappraisal, diaphragmatic breathing) and were asked to record their experiences on an activity log that was collected and discussed in class the following week. Course content was taught from a detailed training manual (Urizar & Kofman, 2012).
15902839|NCT03627676|Procedure|Cryoablation|Two percutaneous cryoprobes would be used for all patients. The 17-Gauge cryoprobes is introduced into the masses under US guidance. Mean distance to the skin has to be 5mm at least. Although US guidance is used, a non-enhanced CT scan may be used to assess the position of the cryoprobes before ablation, and to obtain a baseline examination in order to avoid thermal injuries to adjacent tissues such as the bowel during the ice growth. No ice extension to the skin has to be observed during cycles assessed by real-time US monitoring. Each cryoablation procedure involves 3 successive cycles: 10 minutes freeze with Argon gas, followed by 9 minutes passive and 1 minute active thawing with Helium gas, followed by a second 7 minutes freeze. The ice covered the entire targeted lesion on the short axes is visualize by US or CT-scan performed at the end of the three cycles or after repositioning. At the end of the cryoablation procedures, the probes are removed through active thawing.
15902840|NCT03627663|Behavioral|Dialectic Behavior Therapy - Skills System|Treatment with Dialectical Behavior therapy adapted for cognitively challenged individuals
15902841|NCT03627650|Procedure|lipofilling/ fat grafting|liposuction, processing/ cleaning of fat tissue; reinjection with sharp needle transcutaneous
15902842|NCT03627650|Procedure|placebo injection|
15902843|NCT03627637|Dietary Supplement|Soy nuts|Study volunteers will receive daily 70 g of soy nuts (roasted soybeans containing approximately 100 mg isoflavones). The amount of soy protein provided by the nuts equals the FDA recommended daily intake of 25-30 g.
15902844|NCT03627624|Other|Pulmonary rehabilitation|Stable COPD inpatients undergoing 30-STST and 6-minute walk test (6MWT) before and after PR were included. Responsiveness to PR was determined by pre-to-post PR (Δ) evaluation of 30-STST.
15902845|NCT03627611|Drug|Levothyroxin|3 months
15902846|NCT03627611|Drug|Liothyronine|3 months
15902847|NCT03627598|Device|HFNC|patients will receive high flow warmed air with low inspired fraction of oxygen between non invasive ventilation sessions
15902848|NCT03627598|Device|standard|patients will receive low flow oxygen therapy at 1 to 4 liters per minute
15902849|NCT03627585|Device|Personalised programming|Reprogramming protocol already test in an observation cohort will be utilised which will direct physiologists to consider pacemaker mode, base rate, utilisation of rate response, hysteresis, sleep and rest rates as well as lead outputs.
15902850|NCT03627572|Other|No intervention|Not applicable (no intervention)
15902851|NCT03627559|Procedure|Pancreaticoduodenectomy microdialysis catheter analyses|A thin microdialysis catheter is implanted before skin closure after pancreaticoduodenectomy. Analyses of the microdialysate are done at certain timepoints postoperatively. No intervention is done based on the results. The patients are following standard of care.
15902852|NCT03627546|Drug|Sofosbuvir and Velpatasvir|Sofosbuvir/velpatasvir (Epclusa) is an FDA-approved treatment for HCV. It is provided in the intervention arm as part of a rapid treatment strategy,
15902853|NCT03627533|Procedure|Electroacupuncture|Electroacupuncture therapy is done at the point of CV3 Zhongji, CV4 Guanyuan, and EXCA-1 Zigong with continuous wave, 2 Hz frequency for 30 minutes. Acupuncture manuals on endocrine ear points, GV20 Baihui, ST36 Zusanli, SP6 Sanyinjiao, BL57 Chengsan and KI3 Taixi for 30 minutes.
15902854|NCT03627520|Drug|[14C]Sulfatinib|300 mg Sulfatinib with 100 µCi [14C]
15902855|NCT03627507|Biological|Hepa-B|Incepta will manufacture a locally produced Hepatitis B vaccine named 'Hepa- B' which contain recombinant Hepatitis B surface antigen obtaine. This bulk is formulated to prepare finished dosage to manufacture large scale in fully GMP compliant plant. Incepta has conducted preclinical study at Bioneed, India. After successful completion of preclinical study, this non inferiority clinical trial with innovator product is needed for Licensure in Bangladesh.
15902856|NCT03627507|Biological|Engerix B|.'Engerix B' is a recombinant DNA hepatitis B vaccine. It is sterile suspension of purified surface antigen of hepatitis B virus obtained by culturing genetically yeast cells (Saccharomyces cerevisiae cells), which carry the gene that codes for HBsAg
15902857|NCT03627494|Drug|GSK3439171A|Oral solution with doses 0.5 mg up to 4.5 mg and capsule for doses 5 mg and upwards
15902858|NCT03627494|Drug|Placebo|Placebo oral solution to match with doses 0.5 mg up to 4.5 mg and capsule for doses 5 mg and upwards
15902859|NCT03627481|Procedure|Endoscopic sinus surgery|Endoscopic sinus surgery for nasal polyposis
15902860|NCT03627468|Drug|Sofpironium Bromide Gel, 5%|Sofpironium Bromide Gel, 5%
15902861|NCT03627468|Drug|Sofpironium Bromide Gel, 15%|Sofpironium Bromide Gel, 15%
15902862|NCT03627455|Other|Percutaneous coronary intervention|Percutaneous coronary intervention
15902863|NCT03627442|Procedure|Mastectomy with PhotonBlade|One of the breasts of each patient undergoing double mastectomy will be randomly assigned to breast flap creation with PhotonBlade
15902864|NCT03627442|Procedure|Mastectomy with Bovie|One of the breasts of each patient undergoing double mastectomy will be randomly assigned to breast flap creation with Bovie
15902865|NCT03627416|Device|rTMS|high frequency rTMS to induce the long term potentiation of primary motor areas for the muscles of lower extremities
15902866|NCT03627403|Drug|Selinexor|Selinexor will be administered orally at a dose of 80 mg once weekly until IWG-MR disease progression, intolerable toxicity, or no clinical benefit per treating physician's discretion whichever occurs first.
15902867|NCT03627390|Drug|BP-C1|BP-C1, 0.05% solution for injections; doses: 0.035 mg/kg body weight (0.07 mL/kg) intramuscularly once daily for 32 consecutive days
15902868|NCT03627390|Drug|BP-C2|BP-C2, 0.15% solution for oral use; 15 ml orally once daily for 32 consecutive days
15902869|NCT03627377|Behavioral|Multi-component Intervention for Diabetes in Adults with Serious Mental Illness|Main components of MIDAS include: (1) Education about diabetes and lifestyle, (2) Dietary intervention at the facility and resident level, (3) Increased physical activity, and (4) Smoking cessation / reduction.
15902870|NCT03627338|Diagnostic Test|questionaire, interview|questionaire, interview
15902871|NCT03627325|Other|Patients who are scheduled for any surgical procedure|looking for correlation for estimating the complications between the anesthesiologists and the computerized method.
15902872|NCT03627312|Combination Product|Omega-3|1g of omega-3 supplement to be taken per day for a duration of 3 months in the form of a fruit juice drink
15902873|NCT03627312|Combination Product|Placebo|Fruit juice drink only
15902874|NCT03627312|Other|Treatment as Usual|Young Offenders Intervention Programme
15902882|NCT03627221|Behavioral|music listening and social network|The 12-week combination of music care and social network program consists of three parts: sleep related variables assessment and monitoring, sleep management education and outcome evaluation. Participants in the intervention group will receive weekly online (social network) education and music listening interventions for 12 weeks provided by the PI.
15902883|NCT03627195|Drug|DSP-1349M|DSP-1349M injectable
15902884|NCT03627195|Drug|placebo|placebo injection
15902885|NCT03627182|Drug|CKD-501 0.5mg|CKD-501 0.5mg, orally, 1 tablet once a day for 24weeks or 52weeks(if extension study) with D150 and D745
15902886|NCT03627182|Drug|Placebo|"Placebo, orally, 1 tablet once a day for 24weeks with D150 and D745.
~CKD-501 placebo will be changed to CKD-501 from extension stydy to EOS(end of study)."
15902887|NCT03627169|Device|MATRx plus|The MATRx plus device will be used in its capacity as a Level III home sleep apnea test (HSAT). Note: MATRx plus is approved for use in Canada; therefore, the study does not involve any investigational devices.
15902888|NCT03627156|Behavioral|guided counseling|Community-based guided counseling using Health Belief Model and Theory of Planned Behavior is the intervention package for this study.
15902889|NCT03627143|Other|KTI activities|"The Investigators also plan the following activities to encourage adherence to the guidelines, with an ultimate goal of rhythm or rate control and discharge home for most patients.
~Selection of one or more local physician champions from both the ED as well as the cardiology group;
~Review and discussion of the goals of the study, as well as perceived barriers and enablers, by the ED and cardiology physician groups;
~Formal introduction of the CAEP AAFF Guidelines to the ED physicians and residents by means of presentations at rounds and staff meetings, emails, online video, and web-based resources;
~Development of local action plan addressing local barriers to implementation;
~Provision of the free Smartphone App to be developed for the guidelines;
~Regular reminders provided by the local research staff;
~Audit and feedback charts of site compliance"
15902890|NCT03627130|Drug|Potassium Nitrate|Potassium nitrate capsules (KNO3: 12 mmol giving 744 mg of nitrate) for 5 days
15902891|NCT03627130|Drug|Potassium Chloride|Potassium Chloride capsules for 5 days
15902892|NCT03627117|Drug|Verum|Single vape of 0.25mL of CBD e-Liquid containing: 5% CBD (low-temperature extracted Cannabidiol from Cannabis sativa L., purity 99%), Glycerine (vegetable), Propylene glycol, water
15902893|NCT03627117|Drug|Placebo|Single vape of 0.25ml e-liquid La Baronne Jaune, BORDO2.
15902894|NCT03627104|Dietary Supplement|Normoprotein diet with animal protein|Each patient will be attended for 1 month through 4 weekly visits. Weekly menus will be delivered according to diet with percentage of standard protein (12-18%) with a predominance of animal protein (60%). Regardless of the type of protein, menus will contain the same amount of energy and concentration of carbohydrates, fats and saturated fats (less than 7%).
15902895|NCT03627104|Dietary Supplement|Normoprotein diet with vegetable protein|Each patient will be attended for 1 month through 4 weekly visits. Weekly menus will be delivered according to diet with percentage of standard protein (12-18%) with a predominance of vegetable protein (60%). Regardless of the type of protein, menus will contain the same amount of energy and concentration of carbohydrates, fats and saturated fats (less than 7%).
15902896|NCT03627104|Dietary Supplement|High-protein diet with animal protein|Each patient will be attended for 1 month through 4 weekly visits. Weekly menus will be delivered according to diet with high-protein percentage (25-35%) with a predominance of animal protein (60%). Regardless of the type of protein, menus will contain the same amount of energy and concentration of carbohydrates, fats and saturated fats (less than 7%).
15902897|NCT03627104|Dietary Supplement|High-protein diet with vegetable protein|ach patient will be attended for 1 month through 4 weekly visits. Weekly menus will be delivered according to diet with high-protein percentage (25-35%) with a predominance of vegetable protein (60%). Regardless of the type of protein, menus will contain the same amount of energy and concentration of carbohydrates, fats and saturated fats (less than 7%).
15902898|NCT03627091|Drug|Ontamalimab|SC injection of 25 mg or 75 mg ontamalimab will be administered using a prefilled syringe.
15902899|NCT03627091|Other|Placebo|SC injection of placebo matched with ontamalimab will be administered using a prefilled syringe.
15902900|NCT03627078|Other|motor interference therapy|
15902901|NCT03627078|Other|Relaxation exercises|In a top-down sequence, beginning with the upper body and proceeding to the lower parts. patients contract and relax a specific muscle group following the instructions given by the audio track. We use a shorter version that excludes the legs because of the time.
15902902|NCT03627065|Drug|Parsaclisib|Parsaclisib administered orally once daily at the protocol-defined dose.
15902903|NCT03627052|Drug|Itacitinib|In the double-blind period, itacitinib administered orally once or twice daily at the protocol-defined dose according to treatment group randomization. In the open-label extension, itacitinib administered at doses determined from the double-blind period.
15902904|NCT03627052|Drug|Placebo|Placebo administered orally twice daily in the double-blind period.
15902905|NCT03627039|Drug|SGLT2|All SGLT2 medications approved prior to 2017 will be included (Canagliflozin, empagliflozin, dapagliflozin (all doses, all of the medications are oral)
15902906|NCT03627039|Drug|Metformin|Metformin is the main comparator of interest. In a secondary analysis GLP1 will be the comparator
15902907|NCT03627026|Other|Blood samples will be collected at different time points:|"Baseline
~Week 6 Day 1
~Week 12 Day 1
~If feasible, an optional tumor biopsy specimen will be collected during baseline visit for a maximum of 30 patients included in IUCT-O center."
15902908|NCT03627013|Drug|Custodiol-N Solution|Perfusion
15902909|NCT03627013|Drug|Custodiol HTK Solution|Perfusion
15902910|NCT03627000|Other|failure after reimplantation|description of cinical and microbiological failure
15902911|NCT03626987|Diagnostic Test|mass spectrometry (MALDI-TOF)|The determination of the protein composition of the bacterial spectrum
15902912|NCT03626974|Biological|Venipuncture|Venipuncture for blood collection
15902913|NCT03626974|Device|Diffuser spreading odor|Diffuser will place under a Hood with an air-flow
15902914|NCT03626961|Other|readmission|Readmission after 48 hours
15902915|NCT03626961|Other|discharge|Discharge
15902916|NCT03626948|Drug|SK-1403|Patients receive SK-1403 three times a week administered by intravenous bolus injection at the end of each hemodialysis for the whole treatment periods (52 weeks), with individual dose adjustment.
15902920|NCT03626922|Drug|Oxaliplatin|"Oxaliplatin-Dose level1: 85 mg/m2 IV on Day 1 of each 21 day cycle until a maximum of 35 cycles or until discontinued due to patient election, toxicity, disease progression.
~Dose level 2: 120 mg/m2 IV on Day 1 of each 21 day cycle until a maximum of 35 cycles or until discontinued due to patient election, toxicity, disease progression.
~The MTD dose of oxaliplatin in the study combination of Cohort 2 will be the recommended Phase II dose (RP2D) for the cohort expansion."
15902921|NCT03626922|Drug|Dexamethasone|Dexamethasone-4 mg by mouth twice daily on: the day before, the day of, and the day after each dose of pemetrexed.
15902922|NCT03626922|Dietary Supplement|Folic Acid|Folic Acid-400 micrograms by mouth daily starting 5 days prior to first dose of pemetrexed and continue daily to include 21 days after the last dose of pemetrexed.
15902923|NCT03626922|Dietary Supplement|Vitamin B-12|1000 micrograms administered intramuscularly 7 days prior to the first dose of pemetrexed, every 9 weeks, and should continue until 3 weeks after the last dose of pemetrexed.
15902924|NCT03626909|Other|Primary visit and assessment|"At the initial visit on entry into the program CHW will collect information and the application will guide initial treatment and referral recommendations. At this visit:
~Collection of demographic information and relevant past medical history Medication history, adherence and side effects Glycemic testing, vital signs, and other anthropometric data. Screening for possible complications of diabetes Recommendations for referrals Medication recommendations and counseling"
15902925|NCT03626909|Other|Follow up visits|CHWs will meet with patients once per month to follow up on adherence and tolerance to medications, assess glycemic control, assess for complications of diabetes, refill medications (with dosing adjustments as needed for side effects, non-adherence or poor glycemic control), and provide diabetic education. These monthly visits will be facilitated by the smartphone application monthly protocol
15902926|NCT03626909|Other|3 month visits|At every 3rd monthly visit, starting with the visit 3 months after enrollment, A1c will be assessed. When A1c is checked, the month 3 medication titration algorithm, is used rather than the monthly titration algorithm, which uses blood glucose. Other than checking A1c and using the A1c-based algorithm as indicated, the procedures performed at the month 3 visit are identical to those of the monthly visit.
15902927|NCT03626909|Other|Unscheduled visits|The CHWs live in the same communities as the patients they will be serving. As such, the investigators recognize that patients may come to them with concerns outside of the structure of monthly visits as described above. The investigators have designed an additional module for the smartphone application that guides the CHWs through an assessment for hypoglycemia or severe hyperglycemia and possible complications of diabetes. If a patient or CHW has a concern outside of the scope of these protocols, the CHW will contact a CHW coordinator and/or the medical director for guidance
15902928|NCT03626896|Device|NaviFUS System|BBB Disruption by FUS in recurrent GBM Other Name: Neuronavigation-guided focus ultrasound system
15902929|NCT03626883|Procedure|single-bundle, single-hamstring ACL reconstruction|anterior cruciate ligament reconstruction with single hamstring tendon
15902930|NCT03626883|Procedure|single-bundle, double-hamstring ACL reconstruction|anterior cruciate ligament reconstruction with 2 hamstring tendons
15902935|NCT03626844|Procedure|Manual Lysis of Placenta after 15 minutes (Intervention)|Manual Lysis of Placenta after 15 minutes: We administer prophylactic antibiotics, under epidural analgesia, under aseptic conditions, we perform manual lysis of placenta by introducing the hand through the vagina to the uterine cavity, separating and removing the placenta.
15902936|NCT03626844|Procedure|Manual Lysis of Placenta after 30 minutes (Control)|Manual Lysis of Placenta after 30 minutes: We administer prophylactic antibiotics, under epidural analgesia, under aseptic conditions, we perform manual lysis of placenta by introducing the hand through the vagina to the uterine cavity, separating and removing the placenta.
15902937|NCT03626831|Drug|Evolocumab Prefilled Syringe|Injection of study drug
15902938|NCT03626831|Drug|Placebos|Injection of placebo
15902939|NCT03626792|Other|Hypertensive group|Pilates 12-week training on the ground, often 3 times a week for 50 minutes of prescribed method exercises.
15902940|NCT03626792|Other|Normotensive group|Pilates 12-week training on the ground, often 3 times a week for 50 minutes of prescribed method exercises.
15902941|NCT03626779|Other|Prf|Take 10cc blood from patient and gain prf blug
15902942|NCT03626766|Behavioral|Photo in Verification Alert|Patient photograph displayed in a patient ID verification alert when placing electronic orders in the electronic health record.
15902943|NCT03626766|Behavioral|Photo in Banner|Patient photograph will be displayed in the banner at the top of the screen in the electronic health record.
15902944|NCT03626766|Behavioral|Photo in Banner and Verification Alert|Patient photograph will be displayed in the banner at the top of the screen in the electronic health record AND patient photograph displayed in a patient ID verification alert when placing electronic orders in the electronic health record.
15902945|NCT03626753|Drug|Nefopam 20 MG/ML|given by Oral route the dose of 20mg every 6 hours.
15902946|NCT03626753|Drug|"Nefopam (Acupan) 20 MG/ML Injectable Solution"|given by intravenous route at the dose of 20mg every 6 hours.
15902947|NCT03626753|Drug|"Acetaminophen, (paracetamol) 500Mg Tab"|"2 tablets of Acetaminophen (paracetamol) 500Mg Tab administrated orally every 6 hours."
15902948|NCT03626753|Drug|"(Acetaminophen paracetamol) IV Soln 10 MG/ML"|Acetaminophen IV Soln 10 MG/ML, 1g paracetamol administrated intravenously every 6 hours.
15902949|NCT03626753|Drug|"(Piroxicam piroxan) 20 MG Oral Tablet"|"2 tablets of piroxicam (piroxan) administrated orally once per 24 hours."
15902951|NCT03626740|Other|TheraCal|Caries removal without pulp exposure (stepwise excavation) followed by indirect pulp capping with TheraCal
15902952|NCT03626740|Other|MTA|Caries removal without pulp exposure (stepwise excavation) followed by indirect pulp capping with MTA
15902953|NCT03626727|Drug|Sodium Oxybate Oral Solution [Xyrem]|Xyrem will be given to participants to determine if it is effective in treating post-traumatic narcolepsy and post-traumatic hypersomnia
15902954|NCT03626714|Drug|Sustained Release Injectable Tacrolimus|Long-acting formulation of tacrolimus developed using Auritec's proprietary Plexis drug delivery technology.
15902955|NCT03626701|Device|RECELL® Autologous Cell Harvesting Device|Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings.
15902956|NCT03626701|Combination Product|Mepilex® Ag Wound Dressing|Application of Mepilex® Ag Wound Dressing on partial-thickness burn injury
15902957|NCT03626701|Procedure|Conventional autografting (only when indicated)|When indicated, conventional autografting in accordance with Investigator's standard practice
15902958|NCT03626688|Drug|Ralinepag|Active
15902959|NCT03626688|Drug|Placebo|Placebo
15902960|NCT03626675|Procedure|phaco- trabeculectomy|combined phaco-trabeculectomy surgery
15902961|NCT03626662|Drug|AMG 890|Ascending Single Doses of AMG 890
15902962|NCT03626662|Drug|Placebo|Calculated volume to match experimental drug.
15902963|NCT03626649|Device|DiamondTemp Cardiac Ablation System|"The DiamondTemp Ablation System is the test device in this investigational study. The DiamondTemp Ablation System consists of:
~DiamondTemp Ablation Catheter
~o Unidirectional and Bidirectional models
~DiamondTemp Catheter-to RFG Cable
~DiamondTemp GenConnect Cable
~DiamondTemp FASTR Generator with Footswitch
~DiamondTemp Irrigation Pump
~DiamondTemp Irrigation Tubing Set"
15902964|NCT03626636|Drug|Risuteganib|Subjects injected intravitreally with 1.0mg of Luminate®
15902965|NCT03626636|Other|Sham|Sham injection
15902966|NCT03626623|Device|Cytal Wound Matrix 1-Layer|Cytal® Wound Matrix 1-Layer is composed of a porcine (pig) derived extracellular matrix known as urinary bladder matrix. It is intended for the management of a variety of wounds.The individual device is intended for one time use.
15902967|NCT03626623|Other|Standard of Care (SOC)|Standard of care (SOC) is defined as the usual care a licensed health care provider would give patients to treat diabetic foot ulcers or wounds. SOC associated procedures and policies may vary across clinical settings.
15902968|NCT03626610|Behavioral|Exercise prehabilitation during chemotherapy before surgery|Monitored exercise training in patients with a new diagnosis of oesophageal adenocarcinoma
15902969|NCT03626597|Diagnostic Test|Urine Pregnancy Test|CHV will provide all participants with in-person urine pregnancy tests (UPTs)
15902970|NCT03626597|Behavioral|CHV-based post-test counseling & referral|CHVs will provide in-person post-test counseling & referral to care
15902971|NCT03626597|Behavioral|Phone-based post-test counseling & referral|Participants will call/SMS or be called/SMSed for phone-based counseling & referral to care
15902972|NCT03626584|Other|18F-NaF PET|Hybrid 18F-NaF PET/MR imaging for observational diagnostic purposes
15902973|NCT03626571|Other|18F-FDG|Hybrid 18F-FDG PET/MR or PET/CT imaging for observational diagnostic purposes.
15902974|NCT03626558|Other|ultrasound measures|It is three diaphragmatic ultrasounds measures of a duration of twenty minutes each approximately. The diaphragmatic ultrasound is practised by trans-thoracic way and is non-invasive, completely painless and does not require the exposure of patients to radiation.
15902978|NCT03626532|Behavioral|Mindfulness-Based Stress Reduction (MBSR)|"The MBSR program is a mind-body approach developed by Kabat-Zinn to reduce pain and stress through mindfulness meditation. MBSR is a form of mental training characterized by the self-regulation of attention and focal orientation to present moment experiences. Mindfulness practice is thought to effectively promote emotional and cognitive control. Mindfulness includes directing awareness away from thoughts, emotions and sensations towards some specific anchor to the present, such as the breath. Participants will engage in various practices including breath awareness, body scans, mindful listening, etc."
15902979|NCT03626532|Behavioral|Lifestyle Education (LifeEd)|This group will engage in light stretching exercises at each session. They will also be provided with information drawn from the scientific literature on topics related to healthy aging, including physical activity, sedentary behavior, nutrition, hydration, stress, sleep, and cognitively stimulating activities. Group discussion will be incorporated throughout.
15902980|NCT03626519|Other|Test with Menthol|patients will perform a Six-minute walk test according to American Thoracic Society guidelines
15902981|NCT03626519|Other|Test with placebo|patients will perform a Six-minute walk test according to American Thoracic Society guidelines
15902982|NCT03626506|Drug|Spironolactone|After a 2-week run-in period on amlodipine, patients who still have SBP ≥ 140mmHg will take spironolactone 20mg once daily on top of amlodipine for 12 months. During the first two months after randomization, spironolactone can be titrated to 40mg if office SBP remains ≥ 140mmHg.
15902983|NCT03626506|Drug|Indapamide|After a 2-week run-in period on amlodipine, patients who still have SBP ≥ 140mmHg will take extended-release indapamide 1.5mg once daily on top of amlodipine for 12 months. During the first two months after randomization, indapamide can be titrated to 3mg if office SBP remains ≥ 140mmHg.
15902984|NCT03626506|Drug|Amlodipine|After a 2-week run-in period on amlodipine 5mg once daily, patients who still have SBP ≥ 140mmHg will be randomized to add spironolactone 20mg once daily or extended-release indapamide 1.5mg once daily to amlodipine for 12 months. During the first two months after randomization, amlodipine can be titrated to 10mg if office SBP remains ≥ 140mmHg.
15902985|NCT03626480|Other|No treatment|No treatment
15902986|NCT03626467|Biological|HPV9v|Single-arm, phase 4 study. Patients will be treated with HPV9v vaccine at baseline, week 8 and week 24
15902987|NCT03626454|Drug|Norepinephrine Bolus|'Norepinephrine Bitartarte' bolus of 6 µg/mL for 30 seconds immediately after intrathecal injection
15903140|NCT03625102|Other|placebo|The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects
15902988|NCT03626454|Drug|Norepinephrine infusion|an infusion of 6 µg/mL norepinephrine that was started at 6 µg/kg/h immediately after intrathecal injection
15902989|NCT03626454|Drug|Normal Saline Flush, 0.9% Injectable Solution|10 ml normal saline in syringe for bolus for 30 seconds immediately after intrathecal injection
15902990|NCT03626454|Drug|Normal Saline 0.9% Infusion Solution|50 ml syringe with normal saline infuse at a rate 1ml/kg/h immediately after intrathecal injection
15902991|NCT03626441|Dietary Supplement|Ginger|Capsules containing 0.5g ginger powder, flavoured with non-active essence of ginger
15902992|NCT03626441|Dietary Supplement|Placebo|Two coloured capsules containing 0.5 mg of cornstarch and flavoured with non-active essence of ginger.
15902993|NCT03626415|Drug|PF-04965842|PF 04965842 is an orally bioavailable small molecule that selectively inhibits JAK1.
15902994|NCT03626402|Behavioral|Planning for the Care You Want|25-minute culturally specific educational video informing viewers about advance care planning options, palliative care, and hospice care and meeting with a lay health advisor to discuss content of the video.
15902996|NCT03626376|Drug|oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily|Treatment used in standard of care
15902997|NCT03626376|Drug|oral acyclovir 400 mg BID OR valacyclovir 500 mg qdaily + topical corticosteroid eye drops|Topical steroid medications to be used in this study include Prednisolone acetate 1.0% or Prednisolone sodium phosphate 1%. The choice of formulation will be dependent on physician preference and medication availability. Formulations of other potencies such as Difluprednate emulsion will not be used in this study. Patients in the study arm will be started on topical corticosteroid 1 drop once a day in the affected eye.
15902998|NCT03626363|Behavioral|Stress Management|An eight week stress reduction course.
15902999|NCT03626337|Drug|Thiamine 100 MG/ML|100 mg thiamine provided as intramuscular injection
15903000|NCT03626324|Device|C2P|The C2P is a fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization, including neurogenic lower urinary tract dysfunction (NLUTD - e.g. due to spinal cord injury). The C2P is a sterile, single-extended-use device that resides fully internally to the male lower urinary tract (urethra + bladder neck) for an intended service life of up to 29 days per Catheter.
15903001|NCT03626311|Dietary Supplement|AKBM-3031|"Krill are shrimp-like small crustaceans (up to 6 cm) found in all the world's oceans, but mostly in the Arctic and Antarctic polar seas. Krill are rich in the long-chain omega-3 polyunsaturated fatty acids or LC-PUFAs eicosapentaenoic acid (EPA, C20:5n3) and docosahexaenoic acid (DHA, C22:6n3). The lipid pool of krill is composed of phospholipids and triglycerides and the LC-PUFAs are primarily in the phospholipid fraction.
~The product is produced under food Good Manufacturing Practice (GMP) regulations and has status as GRAS or Generally Recognized As Safe. GRAS is defined by the US Food and Drug Administration (FDA) as a substance that is generally recognized, among qualified experts, to be safe under the conditions of its intended use."
15903002|NCT03626311|Other|Placebo|The placebo will be provided in capsules looking exactly as the krill oil capsules and will contain a fatty acid mixture (olive oil, corn oil, palm oil and medium chain triglycerides) which has the same composition as the average European diet (26.0% C16:0, 4.6% C18:0, 35.8% C18:1n9, 16.7% C18:2n6, 2.1% C18:3n3, 0% C20:4n6 and 14.8% other compounds) and contains no EPA or DHA.
15903003|NCT03626298|Drug|Adapalene|third-generation topical retinoid primarily used in the treatment of mild-moderate acne. It is effective against acne conditions where comedones are predominant.
15903004|NCT03626298|Drug|Nicotinamide, ABA and Zinc PCA|combination of three non-antibiotic active ingredients of nicotinamide, anti-bacterial adhesive agent (ABA) and zinc, or abbreviated as ANAZ to be well-tolerated by patients with acne vulgaris
15903005|NCT03626298|Drug|Placebos|Placebo cream. to resemble an active medication or therapy so that it functions as a control; this is to prevent the recipient(s) and/or others from knowing (with their consent) whether a treatment is active or inactive, as expectations about efficacy can influence results.
15903006|NCT03626285|Procedure|Bone Marrow Transplantation|Undergo BMT
15903007|NCT03626285|Device|CliniMACS CD34 Reagent System|CD34 selection ex vivo
15903008|NCT03626285|Procedure|Peripheral Blood Stem Cell Transplantation|Receive CD34-selected peripheral blood stem cells from related or unrelated donors
15903009|NCT03626272|Other|educational intervention|The simulation scenarios were constructed using the service environment, with real equipment and materials and a low fidelity mannequin. The interventions were not filmed, and the clinical cases elaborated were fictitious, with clear objectives and developed according to the context of the unit. The simulations took place during the working hours of the participants, with the expected duration of the 10 minutes (average) for the scenario, and the average duration of the debriefing was 10 minutes, which took place immediately after the simulation and in the same location of the scenario.
15903010|NCT03626259|Drug|Losartan and Amlodipine|Losartan and amlodipine in fixed combination capsules, 100mg/5mg. One time daily with the first bite of eat meal per 8 weeks
15903011|NCT03626259|Drug|Losartan|Losartan capsules, 100mg. One time daily with the first bite of eat meal per 8 weeks
15903012|NCT03626246|Other|Kidney disease|"Being part of this study you agree to participate in all these interventions:
~Genetic:
~• Blood sample
~Procedure/Surgery:
~• Bone and muscle biopsies.
~Radiation:
~Bone density (DXA)
~Thoracic and lumbar spine plain films.
~HRpQCT: high-resolution peripheral quantitative computed tomography
~Other:
~Completing medical history, physical activity level, and dietary questionnaires for calcium and vitamin D.
~Measure levels of Advanced Glycation End products (AGEs) in the skin."
15903013|NCT03626233|Other|collect of placenta, blood and urinary samples at delivery|collect of placenta, blood and urinary samples at delivery
15903014|NCT03626220|Procedure|acupuncture|manually manipulate acupuncture at CV6 and three acupoints on each arms and legs
15903037|NCT03625986|Other|Nicotine-Containing Electronic Cigarette|"The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a vape pen-style device and comprises a replaceable pre-filled liquid reservoir (tank) and a rechargeable power supply unit. The experimental group in this project will receive a SREC device with liquid containing 15 mg/mL of nicotine."
15903099|NCT03625440|Diagnostic Test|The Digit span test and PASAT with waterpipe smoking|Cognitive tests at baseline and 30minutes after waterpipe smoking
15903169|NCT03624894|Other|impression|common polyvinylsiloxane oral impression
15903015|NCT03626181|Device|Theta Burst Stimulation ( Transcranial Magnetic Stimulation)|"Participants will receive bilateral TBS, 5 times daily (15 minutes between), over 5 consecutive days (25 sessions total). In each session they will receive intermittent TBS (iTBS) over left dorsolateral prefrontal cortex (DLPFC), followed by continuous TBS (cTBS) over right DLPFC. Stimulation sites will be targeted with the Localite neuronavigation system and Visor2 software, and according to Talairach coordinates in relation to individual MRIs. Intensity will be standardized at 120% of RMT.
~The MagPro stimulator will deliver iTBS over left DLPFC with 1620 pulses in 54 triplet bursts (5Hz) with train duration of 2 seconds, and intertrain interval of 8 seconds. cTBS over right DLPFC will consist of 1620 pulses in 54 triplet bursts, train duration of 2 seconds, with no intertrain interval."
15903016|NCT03626168|Dietary Supplement|100% watermelon juice|Participants drank two 12-ounce servings of 100% watermelon juice per day for a four-week period.
15903017|NCT03626168|Other|Placebo beverage|Participants drank two 12-ounce servings of a placebo beverage per day for a four-week period.
15903018|NCT03626155|Behavioral|Walking|Walking will last 50 minutes and will be at 5.0 km/h and at 0.5% incline
15903019|NCT03626155|Behavioral|Seated Control|Participants will be asked to sit quietly and read during a 50 minute control period
15903020|NCT03626129|Procedure|Oximetry guided deflation|"At the cath.lab. (Step 1) a hemostasis test is performed: oxymetry device on the thumb, compress a.ulnaris, evaluate if curve on device (=Patent hemostasis). If patent no further action. If not patent, air is deflated until a.radialis is patent (curve on device and no bleeding). If bleeding occurs before patency then re-inflate 1-2 ml. air until hemostasis (=no patent hemostasis). In patients with Patent hemostasis no action is taken in sixty minutes whereafter the TR-band is fully deflated (Step 2), and if bleeding then air is re-inflated until hemostasis and step 2 is repeated every 20 minutes until the TR-band is fully deflated with hemostasis. If no patent hemostasis at cath.lab. a hemostasis test is performed after 20 min. If patent hemostasis is achieved no action is taken in sixy minutes (as above). If still not patent then further action as in group A."
15903021|NCT03626116|Procedure|silicone metacarpophalangeal arthroplasty (SMPA)|Replacement of the metacarpophalangeal (MCP) joint using a silicone arthroplasty
15903022|NCT03626103|Behavioral|+ Brief ED Intervention (BI)|Brief ED Intervention (BI): A 20-minute Motivational Interviewing- and Cognitive Behavioral Therapy-based in-Emergency Department session delivered by a bachelors'-level Research Assistant
15903023|NCT03626103|Behavioral|+ Text|Text: 8 weeks of an automated, tailored, two-way text-message curriculum started after the ED visit, which reinforces cognitive reappraisal, emotional regulation, and self-efficacy skills. Those that do not show improvement in mood after 7 days will be randomized into LiveText.
15903024|NCT03626090|Biological|Autologous BM MSC|A total of 100-200ml will be harvested from the subject, in either a single or multiple punctures. This will be processed for autologous MSC infusion.
15903025|NCT03626077|Other|physical therapy program|this group received specially designed physical therapy program to facilitate eye-hand coordination and fine motor to improve VMI, VP and MC, which included: unbutton buttons, and button in all again; put the pellets in the bottle as fast as he/she can; place the shapes on its form board; build steps, wall, pyramid and a tower from cubes; cut out a line, square, triangle, and rectangular shapes on a paper by scissor; string squared cubes and lace the holes of strip.Children were trained for 60 minutes per session, three times a week for three consecutive months.
15903026|NCT03626077|Device|E-Link Upper Limb Exerciser|The exercises in the E-Link Upper Limb Exerciser System are in the form of simple and exciting games such as soccer, hitting walls, space shooting, driving, arnd throwing balls into a bucket.Children were trained for 60 minutes per session, three times a week for three consecutive months.
15903027|NCT03626077|Combination Product|physical therapy program and E-Link Upper Limb Exerciser|physical therapy program and E-Link Upper Limb Exerciser. Children were trained for 60 minutes per session, three times a week for three months.
15903028|NCT03626064|Behavioral|Smoking Cessation Counselling|One on one smoking cessation counselling with a certified mental health nurse
15903029|NCT03626064|Drug|Nicotine Replacement Therapy|Access to a range of nicotine replacement therapy: nicotine patch, nicotine gum, nicotine lozenge, nicotine inhaler
15903030|NCT03626051|Device|Rigid tape|This taping method used an anchor, two stirrups, three figure-six's (two preventing inversion and one preventing eversion), heel lock and a lock off. Adhesive rigid strapping tape (Leuko Sports Tape, Beiersdorf Australia Ltd, North Ryde) of 3.8 cm thickness was used for all participants
15903031|NCT03626051|Device|Fibular tape|This taping method used a rigid strapping tape to reinforce a posterior-superior mobilisation of the distal fibula. Tension was applied on the tape in a posterior and superior direction. Adhesive rigid strapping tape (Leuko Sports Tape, Beiersdorf Australia Ltd, North Ryde) of 3.8 cm thickness was used for all participants
15903032|NCT03626038|Device|A.L.P.S. Proximal Humerus Plating System|Anatomically contoured, locking plates that can be customized intra-operatively, multidirectional screws allow for stable fixation for a wide variety of patients.
15903033|NCT03626025|Other|Spaced learning|Instead of learning over a single session, teaching is carried out over a few weekly sessions but maintaining the overall total number of hours spent on teaching
15903034|NCT03626012|Drug|BIIB078|Administered as specified in the treatment arm.
15903035|NCT03626012|Drug|Placebo|Administered as specified in the treatment arm.
15903036|NCT03625999|Behavioral|video game training exercise|"The game, called The Silent Service and developed by our collaborators, is an online game with an underwater theme, and is comprised of 5 distinct mini-games, each of which demands auditory attention. The mission is to navigate an underwater scene, listening and responding to 'sonar' (e.g., an oddball in a stream of sounds). For example, participants may have to respond to an oddball sound stream to protect their submarine from a looming sea monster, while successfully ignoring a distractor sound stream (responses to the distractor sound stream allow the sea monster to damage the submarine). The five games share the same underlying framework of detecting oddballs while ignoring distractors but have unique artwork and 'backstories' to keep players interested. There is a hierarchical reward structure for 'leveling up' across the game that helps players to stay engaged and interested while playing."
15903091|NCT03625505|Drug|Gilteritinib|tablet, oral
15903092|NCT03625492|Behavioral|Reducing Potentially Irritating Beverages|This group will receive a 7 minute video teaching participants to replace beverages that include caffeine, alcohol, artificial sweeteners, or acidic juices with equal volume intake of water, milk, or other beverages that do not have these ingredients in them.
15903038|NCT03625986|Other|Non-Nicotine Electronic Cigarette|"The electronic cigarette (e-cig) used in this study will be the Standardized Research Electronic Cigarette (SREC). The SREC product is a vape pen-style device and comprises a replaceable pre-filled liquid reservoir (tank) and a rechargeable power supply unit. The placebo group in this project will receive a SREC device with liquid containing 0 mg/mL of nicotine."
15903039|NCT03625973|Behavioral|3D-RT|Objects printed using 3D printing media will be used as stimuli in Reminiscence Therapy
15903040|NCT03625973|Behavioral|RT-Verbal|Verbal cues will be used as stimuli in Reminiscence Therapy
15903041|NCT03625960|Drug|Cantharidin|A thin film of cantharidin is applied to the surface of the wart and to 1 millimeter area surrounding the wart. After the film dries, it is covered with an occlusive dressing for 24 hours. The patient removes the area the next day and thoroughly washes the area with soap and water. Patients return to clinic a week later.
15903042|NCT03625960|Drug|Trichloroacetic Acid|Trichloroacetic acid is applied to the surface of the wart with a wooden applicator and after drying the area is washed with soap and water in an hour.
15903043|NCT03625947|Other|Argon Plasma Coagulation|Patients will be treated with Argon Plasma Coagulation. Argon plasma coagulation (APC) is a form of non contact electrocoagulation. APC utilizes electrically conductive argon plasma as a medium to deliver high-frequency current via a flexible probe. The argon plasma flow transfers electricity between the probe and the target tissue. Tracheobronchial access is obtained by passing the probe through the working channel of the bronchoscope. On arrival to the tissue, the application of energy causes uniform zones of desiccation, coagulation and devitalization in the areas receiving treatment, thus inducing hemostasis.
15903044|NCT03625934|Biological|VVX001|5 s.c. injections of 20 micrograms of VVX001 four weeks apart
15903045|NCT03625934|Biological|Placebo|5 s.c. injections of matching Placebo four weeks apart
15903046|NCT03625921|Behavioral|Powered device with physical therapy|Subjects will be fit with a powered prosthesis (Ottobock emPOWER) and enrolled in a device-specific physical therapy (PT) program.
15903047|NCT03625921|Behavioral|Powered device with standard of practice|Subjects will be fit with a powered prosthesis (Ottobock emPOWER) and enrolled in the current standard of practice training, which includes basic device education and prosthetic training.
15903048|NCT03625908|Device|OCT-guided PCI|Patients will receive PCI under OCT-guidance. Predefined criteria for optimization of PCI under OCT-guidance will be recommended to achieve as far as possible.
15903049|NCT03625908|Device|Angiography-guided PCI|Stent optimization using high-pressure non-compliance balloon will be highly recommend. Balloon size would not be less than the stent diameter.
15903050|NCT03625869|Device|PiCSO|After blood flow restoration, the subjects meeting all inclusion and none exclusion criterial will be enrolled into the study and randomized either to PiCSO Group or Control Group. If the subject is randomized to PiCSO Group, the coronary sinus (CS) will be cannulated through the femoral vein and the PiCSO Impulse Catheter will be placed in the CS. Once PiCSO Impulse Catheter is placed into CS, PiCSO treatment is started followed by stenting. The physician shall target a PiCSO treatment of 45 minutes (at minimum 30 minutes) whereas the treatment should be continued during and post stent insertion, but should not exceed a maximum duration of 90 minutes. At the end of the PiCSO treatment, the PiCSO Impulse Console is stopped and the PiCSO Impulse Catheter is removed.
15903051|NCT03625856|Dietary Supplement|Chlorella Vulgaris|Chlorella capsules 1500 mg/day
15903052|NCT03625856|Dietary Supplement|Placebo|Starch 1500 mg
15903053|NCT03625843|Behavioral|Mindfulness exercises|
15903054|NCT03625830|Device|Paclitaxel-eluting PTCA-Balloon Catheter(SeQuent® Please)|SeQuent® Please in length of 10 mm, 15 mm, 17 mm, 20 mm, 26 mm, 30 mm and in diameter of 2.0 mm, 2.5mm, 2.75mm will be used in the trial.
15903055|NCT03625830|Device|rapid exchange PTCA -Balloon Catheter (SeQuent® Neo)|SeQuent® Please in length of 10 mm, 15 mm, 17 mm, 20 mm, 26 mm, 30 mm and in diameter of 2.0 mm, 2.5mm, 2.75mm will be used in the trial.
15903056|NCT03625817|Behavioral|Mountainous setting|The mountainous setting is characterized by lower temperatures (about 8-10C ambient air temp.) than those in urban setting, also having >800m altitude.Each period will last for 1 week with a wash out period of minimum 2 days. Continuous skin temperature and ambient temperature monitoring will take place in the last day of each period, towards the end. During the 2 sampling days, 24-hour urine voids will be collected in different vials. Participants will be required to fulfill a diary with their daily activities, meal times, collection of urine times, sleep/wake times and times of leaving/entering a closed environment.
15903057|NCT03625804|Genetic|PNS+AO+Training|Electrical stimulation was applied to the radial and ulnar nerve (PNS) of the paretic arm for 60 minutes. During the last 30 minutes of PNS, action observation (AO) was introduced in which subjects were required to watch a series of video clips. After one hour's PNS+AO, the subjects then proceeded to a 30-minute period of motor training of paretic hand.
15903058|NCT03625804|Genetic|PNS+AOsham+Training|PNS was given as described before. During the last 30 minutes of the PNS, subjects were shown different photos illustrating a letter, a number or a hand as AOsham. The protocol of motor training was the same as described before.
15903059|NCT03625804|Genetic|PNSsham+AOsham+Training|The 1-hour PNSsham was conducted with the electrical stimulation unit turned on but without current output. The protocols for AOsham and motor training were the same as those described before.
15903060|NCT03625791|Biological|blood sample|1 tube with 4 ml of blood per patient
15903061|NCT03625778|Drug|MEDI0382|MEDI0382 will be administered subcutaneously daily according to the MEDI0382 cohorts.
15903062|NCT03625778|Drug|Placebo|Placebo will be administered subcutaneously daily according to the Placebo cohorts.
15903063|NCT03625765|Device|SmartGoggles|the system is wearable and simulates natural binocular human vision, which minimizes the training curve for new users. The wide-field stereoscopic imaging allows clinicians to rapidly determine the extent of lesions and the hand-held microscopy probe assist clinician to visualize the lesions with high resolution.
15903093|NCT03625492|Behavioral|Adopting the USDA Healthy Eating Habits|This group will receive a 7 minute video teaching them the USDA guidelines for healthy eating.
15903094|NCT03625466|Drug|LUM|Fixed-dose combination (FDC) granule (LUM/IVA)
15903095|NCT03625466|Drug|IVA|FDC tablet or granule (LUM/IVA)
15903096|NCT03625466|Drug|Matched Placebos|Placebo will be used as a comparator.
15903097|NCT03625453|Drug|ABX-1431|Part 1: 8 weeks with daily administration; Patients who choose to enter Part 2: additional 4 weeks with daily administration
15903064|NCT03625752|Device|Active Comparator: Active tDCS + Active TUS|Device: transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes. Device: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.
15903065|NCT03625752|Device|Sham|Device: SHAM Comparator Device: transcranial Direct Current Stimulation (tDCS) Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes. Device: Transcranial Ultrasound (TUS) Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.
15903066|NCT03625739|Drug|anti-tuberculosis drug|The intervention drugs are prescribed by treating caregiver
15903067|NCT03625726|Biological|Thrombin generation assay (in vitro)|One blood sample.
15903068|NCT03625700|Drug|Oxygen gas|Supplementary oxygen supplied via nasal catheter or oxygen mask during hospital admission.
15903069|NCT03625687|Drug|Clinically prescribed direct acting antiviral (Mavyret or Epclusa) HCV treatment for 12 weeks|12 weeks of direct acting antiviral treatment based on clinical indication (either Mavyret or Epclusa)
15903070|NCT03625674|Behavioral|explanation when prescribing psychoactive medicine|explanation of the pathogenesis of FD and the mechanism of psychoactive medicine
15903071|NCT03625661|Drug|Ferinject|Ferinject 50mg/ml, one injection
15903072|NCT03625648|Drug|Pentoxifylline|The non-specific phosphodiesterase inhibitor pentoxifylline (PTX) was approved by the FDA in 1984 for the treatment of peripheral vascular disease.
15903073|NCT03625648|Drug|Placebo|placebo
15903074|NCT03625635|Other|Individualized food-based intervention|Diet plans and recommendations will be based on the individual's nutritional status, symptoms and treatment side-effects, socioeconomic and cultural preferences; as well as the WCRF/AICR guidelines adapting 1.5g/kg/d of dietary protein and when required, a caloric restriction (500-1000 kcal/d). Garlic and cruciferous vegetables will be encouraged as well as 5-9 servings of fruits and vegetables a day. The program will be based on the macronutrient meal-equivalent menu method, and standard food servings will be based on the Mexican Food Equivalent System. Breast cancer patients follow-up will be every 2-weeks and a different diet menu will be provided in each session by a specialized dietitian, unto 6-mo are completed.
15903075|NCT03625622|Drug|AR1001|AR1001 Active Oral Tablet
15903076|NCT03625622|Drug|Placebo|Placebo Oral Tablet
15903077|NCT03625596|Dietary Supplement|L-Arginine|Acute intervention (3 hours)
15903078|NCT03625596|Dietary Supplement|Nitrate / Nitrite|Acute intervention (3 hours)
15903079|NCT03625596|Dietary Supplement|Placebo|Acute intervention (3 hours)
15903080|NCT03625570|Behavioral|Power training combined with interval treadmill training|Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors according to resistance training guidelines for muscle power training. The interval treadmill training portion will include short-bursts (30 seconds) of high speed walking intervals alternating with 30 seconds of low to moderate speed walking for a total of 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
15903081|NCT03625570|Behavioral|Strength training combined with traditional treadmill training|Training will consist of unilateral and bilateral leg presses, targeting the quadriceps, hip extensors, and plantarflexors following the dosing and resistance training guidelines for muscle strength. Traditional treadmill training will consist of walking at steady-state speeds for 30 minutes. Participants will train 3 x per week for 8 weeks. Total duration of each session will be approximately 1 hour.
15903082|NCT03625544|Procedure|Instrumented posterolateral spinal fusion|Instrumented posterolateral spinal fusion, with or without an additional interbody device
15903083|NCT03625544|Device|MagnetOs™ Granules|8-10cc of MagnetOs™ Granules per spinal level at the randomized allocation side of the spine (left or right)
15903084|NCT03625544|Procedure|Autologous bone graft|8-10cc autologous bone graft per spinal level at the control side of the spine (left or right). This can be a combination of local bone and iliac crest bone, but at least 50% of the volume has to be iliac crest bone graft.
15903085|NCT03625531|Other|Acupuncture|Women in both personalized and fixed acupuncture groups will receive acupuncture treatment three times a week. Acupuncture treatment will start on day 3 after a spontaneous period or after a withdrawal bleeding following progestin. Each treatment session will last for 30-60 minutes, with a maximum of 48 treatment sessions over 16 weeks. If they become pregnant, the acupuncture treatment will be stopped. For personalized and fixed acupuncture group, credibility and expectancy questionnaires will be completed on the third acupuncture treatment and the last acupuncture treatment.
15903086|NCT03625531|Drug|Letrozole|Letrozole will be started on day 3 to day 7 of the spontaneous period or a withdrawal bleeding following progestin. If there is response with ovulation, this dose will be maintained. In those with no ovulatory response, letrozole tablets of the next ovulation cycle will be take on the day 28 of the menstrual cycle and the letrozole dose will be increased to 5 mg (2 pills) a day for 5 days. If there is still no response, the dose will be increased to 7.5 mg per day for 5 days in the next cycle. The maximum daily dose of letrozole will be 7.5 mg (3 pills) daily for five days.
15903087|NCT03625531|Drug|Placebo letrozole|Placebo letrozole will be given in the same way as letrozole. Women will receive 1 tablet a day of placebo letrozole from the day 3 to day 7 of the menstrual cycle and placebo letrozole dose will be increased 2 tablets a day in the next cycle if there is no response. The maximum daily dose of placebo letrozole will be 3 tablets daily for five days.
15903088|NCT03625518|Drug|prostaglandins E2|insertion of vaginal PGE2 for up to 30 hours, up to two attempts for cervical ripening and induction
15903089|NCT03625518|Device|intracervical balloon catheter combined with pitocin|insertion of Foley catheter intra cervical and inflating the balloon with 50-60 cc of saline, with IV pitocin according to hospital protocol
15903090|NCT03625505|Drug|Venetoclax|tablet, oral
15903100|NCT03625440|Diagnostic Test|The Digit span test and PASAT without waterpipe smoking|The Digit span test and Paced Auditory Serial Addition Test (PASAT) at baseline and 30minutes later
15903101|NCT03625427|Dietary Supplement|Placebo|The placebo is olive oil, stripped of polyphenols, 70% oleic acid, administered as two 1-gram capsules per day. Packaged as single-serve packets containing 2 capsules for each daily dose.
15903102|NCT03625427|Dietary Supplement|Palmitoleic acid, 500 mg (Dose 1)|Palmitoleic acid (POA) 1 gram capsules containing 500 mg POA
15903103|NCT03625427|Dietary Supplement|Palmitoleic acid, 1,000 mg (Dose 2)|Palmitoleic acid (POA) taken as two 1 gram capsules each containing 500 mg POA
15903104|NCT03625401|Drug|AD-35 60mg group|AD-35 60mg QD
15903105|NCT03625401|Drug|Placebo group|Placebo: 3 placebo of AD-35 30mg tablets
15903106|NCT03625388|Drug|Dasatinib|Film coated tablet contains dasatinib monohydrate
15903107|NCT03625375|Other|Exercise|Intervention consist of aerobic, stretchig, pelvic motions, kegels and relaxation exercises
15903108|NCT03625362|Dietary Supplement|Hydrogen|Hydrogen-rich water
15903109|NCT03625362|Dietary Supplement|Placebo|Tap water
15903110|NCT03625349|Drug|NG-Monomethyl-L-Arginine|Inhibitor of nitric oxide synthase.
15903111|NCT03625336|Diagnostic Test|MRI|An MRI will be obtained utilizing 3 different MRI sequences
15903112|NCT03625323|Drug|Eftilagimod alpha|APC activator, MHC II agonist, LAG-3 fusion protein
15903113|NCT03625323|Drug|Pembrolizumab|anti-PD-1 antibody
15903114|NCT03625310|Drug|Sodium Fluoride|
15903115|NCT03625310|Drug|Sodium Fluoride with TCP|
15903116|NCT03625310|Drug|Sodium Fluoride with CXP|
15903117|NCT03625310|Drug|Sodium Fluoride with CPP-ACP|
15903118|NCT03625297|Other|shelter cat|families will adopt a shelter cat
15903119|NCT03625284|Dietary Supplement|Placebo|Edible oil
15903120|NCT03625284|Dietary Supplement|FucoVital|Microalgae oil extract
15903121|NCT03625271|Device|The PEER Report|PEER Interactive references a subject's QEEG to a normative and then symptomatic database. By comparing a given subject's QEEG to a database of QEEGs of subjects who have tried and responded to a specific medication, PEER provides useful information regarding the response of neurophysiologically similar subjects to a wide number of medications - providing clinicians with useful information as to medication outcomes before a medication regime is started. Clinicians have also reported that negative findings (in which neurophysiologically similar subjects reported resistant outcomes for certain medications) can be extremely useful in reducing trial and error. It has also been used to help select the medication that best matches the QEEG brainwave pattern.
15903122|NCT03625245|Other|Control Yogurt|125 g/day
15903123|NCT03625245|Other|Yogurt Variety 1|125 g/day
15903124|NCT03625245|Other|Yogurt Variety 2|125 g/day
15903125|NCT03625232|Device|CompuFlo® Epidural Computer Controlled System|"The CompuFlo® Epidural Instrument allows the objective identification of the epidural space by pressure measurement at the needle tip and consequently enables the HCP to perform epidural anesthesia and epidural injections using standard methods. Currently, HCPs rely on their subjective perception to feel a loss of resistance when inserting an epidural needle to identify the epidural space. The CompuFlo® Epidural Computer Controlled Anesthesia System has received a CE mark in the European Union and it received 510(k) clearance from the FDA in June 2017."
15903126|NCT03625219|Drug|Prednisone|40 mg (8 x 5mg tablets) for three consecutive days, then 30 mg (6 x 5mg tablets), 20 mg (4 x 5 mg tablets), 10 mg (2 x 5 mg tablets) and 5 mg (1 x 5 mg tablet) daily for two consecutive days for each dose level for a total of 11 days of treatment.
15903127|NCT03625219|Drug|Placebo|8 tablets for 3 consecutive days; then 6 tablets, 4 tablets, 2 tablets, and 1 tablet daily for 2 consecutive days for each tablet count for a total of 11 days
15903128|NCT03625206|Behavioral|Cognitive bias modification training|These training sessions aim to modify a selective attention bias towards threat and a tendency to interpret ambiguous situations in threatening ways
15903129|NCT03625206|Behavioral|Control training|These exercises are matched to the task demands of the modules of cognitive bias modification training
15903130|NCT03625180|Biological|NAMIC: nanofractured autologous matrix-induced chondrogenesis|the NAMIC technique consists in: debridement of damaged tissue, removal of calcified cartilage with retention of healthy surrounding vertical cartilage, minimally invasive subchondral bone marrow stimulation, nanofracture (Nano FX, Arthrosurface, USA), and a posteriori protect the lesion, stabilization of the clot, and facilitate stem cell adhesion and proliferation that migrate from the bone marrow with a type I/ III collagen and elastine membrane (Cartimaix, Matricel, Germany).
15903131|NCT03625167|Other|Treatment with petrolatum|Petrolatum is applied twice daily to the intervention arm.
15903132|NCT03625154|Procedure|ankle open reduction internal fixation|Open Reduction and Internal Fixation with plates and screws
15903133|NCT03625154|Other|non operative management|closed reduction and splinting followed by progressive weight bearing
15903134|NCT03625141|Drug|Cobimetinib|60 mg (three tablets of 20 mg each) orally (PO) once a day (QD) on Days 1-21 of each 28-day cycle.
15903135|NCT03625141|Drug|Atezolizumab|"Atezolizumab will be given at a fixed dose of 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
~Only for cohort 2, no dose of atezolizumab will be given during the run-in period (cycle 1)."
15903136|NCT03625141|Drug|Vemurafenib|Participants will receive vemurafenib 960 mg (four 240 mg tablets) orally (PO) twice daily (BID) on days 1-21 of the run-in period (cycle 1); thereafter, they will receive vemurafenib 720 mg dose (three 240 mg tablets) PO BID on days 22-28 of cycle 1 and on days 1-28 of all subsequent cycles.
15903137|NCT03625128|Drug|F-18|This is an open-label study to evaluate the performance of a novel tau imaging ligand in up to 36 subjects (12 AD, 3 FTD, 3 PSP, 3 CBS, 3 VCI and 12 HV).
15903138|NCT03625115|Behavioral|Family Navigator (FN)|The intervention will be a modified Patient Navigator model, that we will refer to as a Family Navigator (FN) model, that will engage, inform, and assist participating parents to follow-through with the process of EI referrals and services. Eligible children randomized to the intervention arm will be provided with services from a FN. The FN will maintain contact with the family, the child's primary care provider, and Early Intervention staff, if applicable, throughout the duration of the study.
15903139|NCT03625102|Drug|Antroquinonol|Antroquinonol will be provided as a capsule-shaped which contain 50 mg Antroquinonol.
15903237|NCT03624296|Other|TEST EDSS|EDSS - Expanded Disability Status Scale
15903141|NCT03625089|Drug|Atorvastatin|"Group 1 patients will be prescribed statin when FRS > 10%; while group patients will be prescribed statin upon presence of carotid plaque as reported from carotid ultrasound. The decision will solely be made base on the randomized group by either FRS>10% or presence of carotid plaque.
~Atorvastatin 20 mg is recommended as the preferred initial high intensity statin to use because it is clinically and cost effective for the primary prevention of CVD according to the national institute for Health and Care Excellence (NICE) guideline from the United Kingdom."
15903142|NCT03625076|Drug|Intra-articular Lidocaine|20 mL of 1% Lidocaine will be injected into the joint of the dislocated shoulder. Afterwards, the physician will attempt to reduce the shoulder using a technique of his or her choice.
15903143|NCT03625076|Drug|Procedural Sedation with etomidate or propofol|Procedural sedation using etomidate or propofol (physician's choice) will be performed. The dose of the drugs will also be left the treating physician. The physician will then attempt to reduce the shoulder using a technique of his or her choice.
15903144|NCT03625063|Other|Exercise training group|All exercise program will be applied during supervised session by a physiotherapist. Range of maximal heart rate will be screened by heart rate monitor during supervised session each day at patient's room. Inspiratory muscle training (threshold loading device (Threshold®- Inspiratory Muscle Trainer) at 20-30% of maximal inspiratory pressure (MIP)), upper extremity aerobic exercise training (arm ergometer, at 60-80% of maximum heart rate, dyspnea perception at 3-4 level as well as fatigue perception at 5-6 level according to Modified Borg Scale) and progressive resistance training (shoulder flexors, shoulder abduction and knee extensors at 4-6 level according to modified Borg scale) will be performed in the treatment group during acute hematopoietic stem cell transplantation process.
15903145|NCT03625063|Other|Control training group|All exercise program will be applied during supervised session by a physiotherapist. Range of maximal heart rate will be screened by heart rate monitor during supervised session each day in patient's room.Upper extremity aerobic exercise training (arm ergometer, at 60-80% of maximum heart rate, dyspnea perception at 3-4 level as well as fatigue perception at 5-6 level according to Modified Borg Scale) and progressive resistance training (shoulder flexors, shoulder abduction and knee extensors at 4-6 level according to modified Borg scale) except inspiratory muscle training will be performed in the control group during acute hematopoietic stem cell transplantation process.
15903146|NCT03625050|Procedure|Chuna + Usual care(Celecoxib and esomeprazole)|"Chuna therapy (CT), 2 sessions/week, 4 weeks (8 sessions in total) Usual care therapy (UC, Celecoxib 200mg, qd and esomeprazole 20mg, qd), 4 weeks
~Usual care consists of physical therapy, CP based medications and patients education. Physical therapy consists of meridian muscle interferential current electricity (or meridian transcutaneous electricity) and hot pack (or infrared lamp).
~CT and UC group will receive the same UC regimen."
15903147|NCT03625050|Drug|Usual care(Celecoxib and esomeprazole)|"Usual care therapy (UC, Celecoxib 200mg, qd and esomeprazole 20mg, qd), 4 weeks
~Usual care consists of physical therapy, CP based medications and patients education. Physical therapy consists of meridian muscle interferential current electricity (or meridian transcutaneous electricity) and hot pack (or infrared lamp)."
15903148|NCT03625037|Biological|Epcoritamab|Epcoritamab will be administered in cycles of 4 weeks i.e. 28 days.
15903149|NCT03625024|Behavioral|Cognitive-behavioral therapy|Individual cognitive-behavioral therapy, including homework and behavioral change methods.
15903150|NCT03625011|Drug|Gabapentin|This double blinded randomized control trial will enroll 50 children age 3-18 years, undergoing T/As. Patients will be receiving either one gabapentin dose (15mg/kg up to 600mg) or placebo preoperatively. Both control and test group will receive the standard narcotic regimen intraoperatively.
15903151|NCT03624998|Other|Cognitive and physiatric testing|Neuropsychological test battery and physiatric tests
15903152|NCT03624985|Drug|Intravenous Lidocaine Infusion|Patients will be randomly assigned to receive 1 mg/kg lidocaine bolus and intraoperative infusion of 2 mg/min.
15903153|NCT03624985|Drug|Placebo Infusion|Patients will be randomly assigned to receive a 1mg/kg bolus of water with 5% dextrose and an intraoperative infusion of 2mg/min. of water with 5% dextrose
15903154|NCT03624972|Behavioral|Starting the Conversation Video|The Starting the Conversation program is designed to increase self-efficacy and outcome expectancies for communicating with providers about sexual health and related issues, reduce barriers to communication, and provide basic training in skills for communicating with providers about these topics, including prioritizing concerns, tips for effective communication, communication practice, and self-feedback.
15903155|NCT03624972|Behavioral|Sexual and Menopausal Health Resources|Patients will receive a resource list that includes both web-based resources on menopausal and sexual health and center-specific resources, such as contact information for a menopausal & sexual health clinic.
15903156|NCT03624959|Drug|Ozanimod|ozanimod
15903157|NCT03624959|Drug|Gemfibrozil|Gemfibrozil
15903158|NCT03624959|Drug|Itraconazole|Itraconazole
15903159|NCT03624959|Drug|Rifampin|Rifampin
15903160|NCT03624946|Biological|Zika Virus Immune Globulin (ZIKV-IG)|Zika Virus Immune Globulin (ZIKV-IG) is a human immune globulin preparation containing neutralizing antibodies to Zika virus.
15903161|NCT03624946|Other|Placebo|Placebo is a normal saline solution (0.9% sodium chloride).
15903162|NCT03624933|Behavioral|Weekly Behavioral Coaching Session|The participants will be provided with a 20-minute individual behavioral support session weekly for 4 weeks (28 days of abstinence), designed to provide them with tools and techniques to manage the craving and withdrawal symptoms that occur with cessation.
15903163|NCT03624933|Behavioral|Contingency Management|If the participant's weekly abstinence is successful as determined by the urine results on day 28, the participant will receive an additional $300.00 cash bonus on top of their hourly $10 compensation for attending all visits. We predict that this cash bonus is enough incentive to allow for the behavioural change of abstinence in this patient population.
15903164|NCT03624920|Drug|THN102 Dosage A|THN102 Dosages A: placebo
15903165|NCT03624920|Drug|THN102 Dosage B|THN102 Dosage B : 200mg/2mg
15903166|NCT03624920|Drug|THN102 Dosage C|THN102 Dosage C: 200mg/18mg
15903167|NCT03624907|Radiation|Daily Stereotactic Body Radiotherapy|After randomization, participants will receive daily standard of care doses of radiotherapy at treating physicians discretion.
15903168|NCT03624907|Radiation|Non-Daily Stereotactic Body Radiotherapy|After randomization, participants will receive non-daily standard of care doses of radiotherapy at treating physicians discretion.
15903170|NCT03624881|Device|Catheter ablation with EPU|Subjects undergoing electrophysiology mapping and RF ablation with THERMOCOOL SMARTTOUCH ® SF (STSF) and THERMOCOOL SMARTTOUCH ® (ST) catheters with VISITAG SURPOINT Module with External Processing Unit for pulmonary vein isolation
15903171|NCT03624868|Behavioral|Tai Chi|See above description
15903172|NCT03624868|Behavioral|Wellness Education|See above description
15903173|NCT03624855|Other|Bone or joint infection due to Pseudomonas aeruginosa|Description of bone or joint infection on implant due to Pseudomonas aeruginosa
15903174|NCT03624842|Drug|Trappsol (R) Cyclo (TM)|
15903175|NCT03624829|Other|Shared care|The intervention is an adapted version of shared care with close collaboration by services and professional groups, mainly localized in three GP centers. At each GP center one clinical psychologist specialist from the community mental health center (CMHC) works two and a half day a week, and a psychiatrist from the CMHC work at each GP center 1-2 hours a week. The psychologist and the psychiatrist are available for the GPs for consultation and discussions, and they give assessments and brief treatments to patients as requested by the GPs. Other primary health and social care and other specialized mental health or substance addiction services are involved or consulted according to needs of the patients.
15903176|NCT03624816|Device|Restylane Defyne|hyaluronic acid dermal filler gel
15903177|NCT03624790|Biological|rRSV A/Maryland/001/11|10^5 PFU; delivered intranasally
15903178|NCT03624777|Behavioral|Outdoor Fall prevention brochure|Participants in the wait list control group will initially receive written information only about preventing outdoor falls
15903179|NCT03624777|Behavioral|Stroll Safe outdoor fall prevention program|Participants in the treatment group will attend a once a week 7-week outdoor fall prevention program that includes didactic presentations, group discussions/ problem solving, practice in strategy use, and action planning for safe community mobility.
15903180|NCT03624764|Procedure|Laparostopic promontofixation using surgical glue|The technique involves implanting a prosthetic tissue (tape) between the bladder and the vagina, suspending the cervix or the vagina affectionately, associated or not with a posterior strip placed between the rectum and the vagina fixed on the small pelvis muscles. Each strip is held by the surgical glue (cyanoacrylate biocompatible adhesive)
15903181|NCT03624764|Procedure|Laparostopic promontofixation using threads|The technique involves implanting a prosthetic tissue (tape) between the bladder and the vagina, suspending the cervix or the vagina affectionately, associated or not with a posterior strip placed between the rectum and the vagina fixed on the small pelvis muscles. Each strip is held by sutures with threads
15903182|NCT03624751|Radiation|radioiodine|Patients with thyroid cancer need to choose between Thyrogen® injection and Eltroxin® withdrawal before radioiodine therapy or scan.
15903183|NCT03624738|Procedure|Procedure|"Patients with redo cardiac surgery 1: femoral artery-femoral vein cardiopulmonary bypass (CPB) in order to achieve cardiac decompression prior to sternotomy.
~Patients with redo cardiac surgery 2: only conventional aortobicaval cannulation will be used"
15903184|NCT03624725|Procedure|modified BII+Braun|modified BII+Braun digestive tract reconstruction
15903185|NCT03624712|Diagnostic Test|uterine neoplasms|Analysis of circulating (CTC) and disseminating tumor cells (DTC), determination of Human Papilloma Virus (HPV), Douglas cytology, DNA analysis in blood, proteome analysis, sentinel lymph node detection
15903186|NCT03624699|Device|Glaukos iStent inject®|iStent inject® Devices Implanted in Combination with Cataract Surgery in Patients with Open-Angle Glaucoma
15903187|NCT03624686|Other|peripheral blood|draw peripheral blood
15903188|NCT03624673|Procedure|endoscopic robot-assisted simple enucleation|Simple enucleation consists of excising the tumor by blunt dissection following the natural cleavage plane between the peritumoral capsule and the renal parenchyma without removing a visible rim of healthy renal tissue.
15903189|NCT03624673|Procedure|standard robot-assisted partial nephrectomy|Standard partial nephrectomy is defined as the excision of the tumor and of an additional margin of healthy peritumor renal parenchyma.
15903190|NCT03624660|Radiation|HR-A|"The prostate and proximal seminal vesicles will be treated to 2 cobalt gray equivalent per fraction for 39 fractions for a total of 78 cobalt gray equivalent.
~Simultaneous integrated boost to the IPT will be delivered to 2.2 cobalt gray equivalent per fraction for 39 fractions for a total of 85.8 cobalt gray equivalent.
~Treatment will be given once a day, approximately 5 treatments per week (Monday- Friday), over 8-9 weeks."
15903191|NCT03624660|Radiation|HR-B|"The prostate, proximal seminal vesicles, and pelvic nodes will be treated to 2 cobalt gray equivalent per fraction for 23 fractions for a total of 46 cobalt gray equivalent.
~The prostate and proximal seminal vesicles will be treated to an additional 2 cobalt gray equivalent per fraction for 16 fractions for a total of 32 cobalt gray equivalent.
~Electively treat the entire uninvolved seminal vesicle to 2 cobalt gray equivalent per fraction for 39 fractions for a total of 78 cobalt gray equivalent when part of the seminal vesicle is involved with tumor.
~Simultaneous integrated boost to the IPT will be delivered to 2.2 cobalt gray equivalent per fraction for 39 fractions for a total of 85.8 cobalt gray equivalent.
~Treatment will be given once a day, approximately 5 treatments per week (Monday- Friday), over 8-9 weeks."
15903192|NCT03624647|Device|Power toothbrush|Experimental power toothbrush
15903193|NCT03624647|Device|Manual toothbrush|Marketed manual toothbrush
15903194|NCT03624621|Behavioral|Functional Remediation|Functional remediation includes directed group sessions tapping into the main cognitive domains affected in depression (executive functioning, attention and memory) as well as their implication in daily living.
15903195|NCT03624621|Device|Computerized Cognitive Training (CCT)|12 add-on sessions (20-minute long) after each group session to train cognitive domains.
15903196|NCT03624621|Behavioral|Psychoeducation|12 sessions of psychoeducation on depression, providing information about the disease, causes, consequences and other useful data for the management of depression.
15903197|NCT03624621|Device|Online games|Participants play non-directed online games during 20 minutes after each psychoeducation grup session to make the two active intervention more similar.
15903198|NCT03624608|Device|AuryzoN Family of Devices|The AuryzoN family of devices includes a longitudinal cartilage trimmer (DimensioN) and 2D shape carving machine with custom blades (AuryzoN).
15903238|NCT03624296|Other|TEST MSFC|MSFC - Multiple Sclerosis Functional Composite
15903239|NCT03624283|Drug|Betahistine|Betahistine is used in the treatment of and vertigo.
15904249|NCT03616457|Device|Automated Breast Ultrasound (ABUS)|Participants will undergo imaging with ABUS.
15903199|NCT03624595|Drug|Dexmedetomidine|Dexmedetomidine infusion is administered from 16:00 to 08:00 during the night of surgery in the intensive care unit; and will repeated for a maximum of 5 consecutive nights. For patients with mechanical ventilation, the infusion rate is 0.2-0.7 ug/kg/h; for those without mechanical ventilation, the infusion rate is 0.05-0.2 ug/kg/h. The target depth of sedation is Richmond Agitation-Sedation Scale (RASS) -1.
15903200|NCT03624595|Drug|Placebo|Placebo (normal saline) infusion is administered in the same rate for the same duration as in the dexmedetomidine group. The conventional sedation is provided when necessary with propofol and/or midazolam by intravenous infusion/injection. The target depth of sedation depth is RASS -1.
15903201|NCT03624569|Other|Bagel|A bagel will be consumed daily for 2 weeks.
15903202|NCT03624569|Other|Potato|A potato will be consumed daily for 2 weeks.
15903203|NCT03624556|Dietary Supplement|EGCG FontUp|Intake of 10mg/kg/day of EGCG, in the form of a dietary supplement (FontUp), two times a day.
15903204|NCT03624556|Other|Placebo FontUp|Intake of placebo, in the form of a dietary supplement (FontUp) (without EGCG), two times a day.
15903205|NCT03624543|Drug|CFI-400945|32mg; 28 day cycles; Cycle 1: Days 1-7 then 15-21 Cycle 2 onward: Daily
15903206|NCT03624530|Drug|Tyrosine kinase inhibitor (TKIs)|TKI was selected according to the mutation results of ABL kinase region. Imatinib was initiated at a dose of 200mg/d, dasatinib at a dose of 50mg/d, and ponatinib at a dose of 30mg/d. Then increase the dosage of TKI gradually and increase to therapeutic dose within one month. The duration of TKI was 180 days.
15903207|NCT03624517|Drug|Octreotide|Octreotide infusion for 24-hours in patients with bleeding esophageal varices.
15903208|NCT03624504|Device|Micra Transcatheter Pacing System (TPS)|Treatment of subjects eligible for the single chamber ventricular pacemaker per study requirements
15903209|NCT03624491|Other|Esophageal pressure measurement guided ventilation|Use of esophageal pressure measurements to guide mechanical ventilation
15903210|NCT03624478|Radiation|Hypofractionated Radiation Therapy|Undergo hypofractionated radiation therapy
15903211|NCT03624465|Device|Levita Magnetic Surgical System|Device for use as a surgical tool.
15903212|NCT03624452|Other|rIPC + Exercise|The interventions consist of exercise training on a static bike three times per week and/or three bouts of rIPC per week for 8 weeks. A single bout of rIPC consists of cycles of upper arm cuff inflation for 5 minutes, followed by 5 minutes cuff deflation repeated 4 times.
15903213|NCT03624452|Other|rIPC only|Three bouts of rIPC per week for 8 weeks. A single bout of rIPC consists of cycles of upper arm cuff inflation for 5 minutes, followed by 5 minutes deflation repeated 4 times.
15903214|NCT03624439|Device|Standard double-lumen tube|intubation using standard double-lumen tube with Macintosh laryngoscope
15903215|NCT03624439|Device|Double-Lumen Tube Vivasight-DL|intubation using Double-Lumen Video Tube Vivasight-DL with Macintosh laryngoscope
15903216|NCT03624426|Device|Automated Somatosensory Evoked Potential device (EPAD@)|After commencement of general anesthesia and during patient positioning, stimulating sensors will be applied to patient wrists and a recording sensor is applied at base of neck posteriorly (at C5 level), forehead and the bilateral wrists. The monitoring will be continued throughout the surgery.
15903217|NCT03624413|Behavioral|Social Media Intervention|The social media intervention is a behavioral intervention developed by the study investigators and is delivered via mobile phones. The intervention uses the Social-ecological Model of Adolescent and Young Adult Readiness to Transition (SMART) model, highlighting modifiable targets of intervention that can be addressed through a social media platform. The SMART model incorporates modifiable factors such as knowledge, skills/self-efficacy, relationships and social support that can be targets of interventions to improve transition care. The SMART model emphasizes eight modifiable factors, three key stakeholders (adolescents, caregivers, and clinicians) and their interconnected relationship in influencing successful transition to adult care. The intervention is designed to overcome barriers and enhance facilitators to transitioning care among adolescents living with HIV who are transitioning to adult care in South Africa.
15903218|NCT03624413|Other|Standard of Care|Standard of care transition from pediatric to adult care for HIV.
15903219|NCT03624400|Behavioral|Internet-based CBT-I|The adapted Internet-based CBT-I for adolescents with ASD includes sleep hygiene, restriction of time in bed, stimulus control, cognitive therapy, and relaxation techniques. The treatment consists of 10 weekly modules and each module consists of several website pages that will be presented in a fixed order, with preprogrammed modules containing information, interactive questionnaires, descriptions of exercises and movies.
15903220|NCT03624400|Behavioral|Internet-based psychoeducation|Internet-based psychoeducation contains information about ASD, sleep difficulties and aspects of sleep hygiene. The intervention takes place in 10 weeks modules.
15903221|NCT03624387|Other|Painting Sessions|During the GIA painting session, each participant will be given a white canvas, four brushes and four different colors of painting.Their only instruction will be to cover the white color of the canvas. At the end of each session, the performance of the participants will be evaluated based on their neuropsychological conditions before and after Geriatric Inclusive Art session.
15903222|NCT03624361|Device|Glaucoma device implantation in a stand-alone procedure|"MINIject implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive Glaucoma surgical intervention.
~The intervention is to be performed as stand-alone surgery."
15903223|NCT03624348|Behavioral|meditation|10 minute per day, 8 week digital meditation
15903224|NCT03624335|Procedure|ECC|Early clamping of the umbilical cord
15903225|NCT03624335|Procedure|DCC|Delayed clamping of the umbilical cord
15903226|NCT03624335|Procedure|Blood Test 6hours|Blood Test 6hours
15903227|NCT03624335|Procedure|Blood Test 24hours|Blood Test 24hours
15903228|NCT03624335|Procedure|Blood Test 48hours|Blood Test 48hours
15903229|NCT03624335|Procedure|Blood Test 28days|Blood Test 28days
15903230|NCT03624322|Drug|Zyprexa IM|5mg
15903231|NCT03624322|Drug|Zydis|10mg orally disintegrating wafer
15903232|NCT03624322|Drug|INP105|Single, ascending doses of 5, 10, or 20mg capsules OLZ (olanzapine) or placebo (MCC)
15903233|NCT03624322|Device|I231 POD® Device|Precision Olfactory Delivery (POD) device
15903234|NCT03624309|Drug|Anlotinib Plus Docetaxel|Anlotinib (12mg QD PO d1-14, 21 days per cycle) and Docetaxel (75mg/m2 IV d1)
15903235|NCT03624309|Drug|Docetaxel|Docetaxel (75mg/m2 IV d1)
15903236|NCT03624296|Device|MRI 7T|MRI 7T
15903240|NCT03624283|Behavioral|Exercise-based vestibular rehabilitation|Exercise-based vestibular rehabilitation (VR) has proven to be an effective way for managing dizziness by relieving symptoms and improving balance and postural stability.
15903241|NCT03624270|Drug|Oral arsenic Trioxide, ATRA and ascorbic acid|Oral arsenic trioxide-based frontline induction, consolidation and maintenance will be provided to patients with newly diagnosed acute promyelocytic leukemia.
15903242|NCT03624257|Device|Laser treatment|The participants in the laser group are treated by a combination of scaling and root planning (SRP) and 445 nm diode laser. The peri-implant pocket will be radiated with the 445 nm laser, removing bacteria, diseased epithelium and granulation tissue. The Power setting on the laser will be 0.7 W continuous wave and will be used at maximum 20 s Before cooling water is applied. Total treatment time will vary with the depth of the pocket and size of the surrounding bone crater.
15903243|NCT03624257|Procedure|Mucosal flap surgery|The participants will receive a conventional peri-implant mucosal flap surgery of affected implants, in combination with scaling and root planning (SRP), and return after 7-10 days for suture removal. The surgery is a well-established treatment of peri-implantitis.
15903244|NCT03624244|Drug|Aromatase Inhibitors|Maintenance of AI versus interruption of AI
15903245|NCT03624231|Drug|Durvalumab|Durvalumab (1500 mg) starting on week 1 to complete a total of 12 months
15903246|NCT03624231|Drug|Tremelimumab|Tremelimumab (75 mg) for up to 4 doses/cycles
15903247|NCT03624231|Radiation|Radiotherapy|Radiotherapy with 35 fractions (administered as daily fractions of 2 Gy given 5 days every week for 7 weeks)
15903248|NCT03624218|Behavioral|Prolonged Exposure Therapy|Using a combination of In vivo and Imaginal exposure, Prolonged Exposure therapy aims to treat those with Posttraumatic Stress Disorder.
15903249|NCT03624205|Device|paclitaxel-releasing coronary balloon (SeQuent® Please)|SeQuent® Please with a length of 10mm,15mm,17mm,20mm and 26mm and diameter of 2.5 mm, 2.75 mm, 3.0mm, 3.5mm and 4.0mm are to be used in the trial
15903250|NCT03624192|Device|RECELL® Autologous Cell Harvesting Device|Application of RES prepared using the RECELL® Autologous Cell Harvesting Device along with Telfa™ Clear primary and Xeroform™ secondary wound dressings
15903251|NCT03624192|Other|Telfa™ Clear and Xeroform™ dressings|Telfa™ Clear and Xeroform™ dressings
15903252|NCT03624166|Drug|Ketamine|patients will receive sub- anesthetic dose of ketamine 0.5 mg/kg in 3 ml of isotonic saline after spinal anesthesia
15903253|NCT03624166|Drug|isotonic saline|patients will receive 3 ml of isotonic saline after spinal anesthesia
15903254|NCT03624153|Behavioral|Robotic-assisted intervention|Participants received the 12-session robot-assisted intervention 3 sessions a week for 4 consecutive weeks. Each session consisted of 20-minute continuous passive motion, 20-minute active motion practice, and 30-minute task-oriented practice.
15903255|NCT03624153|Behavioral|Conventional rehabilitation intervention|Participants received the 12-session conventional rehabilitation intervention 3 sessions a week for 4 consecutive weeks. The intervention consisted of warm up including range of motion exercise, and strengthening exercise followed by task-oriented training for activities of daily living.
15903256|NCT03624140|Device|blood measurement|Hemoglobin measurement
15903257|NCT03624140|Device|pulse co-oxymeter (SpHb)|non invasive method of hemoglobin measurement
15903258|NCT03624140|Device|hemoCue|non invasive method of hemoglobin measurement
15903259|NCT03624127|Drug|BMS-986165|Specified dose on specified days
15903260|NCT03624127|Other|Placebo|Specified dose on specified days
15903261|NCT03624127|Drug|Apremilast|Specified dose on specified days
15903262|NCT03624114|Procedure|comparison of data from MRI with data from CT compared with intraoperative data from endoscopic pituitary adenoma surgery|A comparison of MRI with CT of the skull base or paranasal sinuses and intraoperative Video documentation of the anatomical site will be used.
15903263|NCT03624101|Drug|Trikafta|CFTR modulator
15903264|NCT03624101|Drug|symdeko/Trikafta|CFTR modulator
15903265|NCT03624101|Drug|Ivacaftor/Trikafta|CFTR modulator
15903266|NCT03624088|Behavioral|RealRisks|RealRisks is a web-based patient decision aid with modules on risk assessment, family history and breast cancer, genetic testing, and prevention options. Participants enter family history data into RealRisks, and RealRisks calculates 5-year breast cancer risk, lifetime breast cancer risk, and the probability of carrying a BRCA mutation. This information is then interactively presented to the participant. RealRisks facilitates the participant in identifying their intention to undergo BRCA genetic testing and the factors that are important to the participant in making this decision. RealRisks produces a summary of all of this information that the participant can print and take with her to a health care appointment.
15903267|NCT03624075|Other|application of kinesio taping|application of kinesio taping in the rectus femoris muscle and in the medial and lateral region of the knee
15903268|NCT03624062|Drug|MAS-1 adjuvanted Insulin B-chain|MER3101 (MAS-1 adjuvanted insulin B chain (IBC)), is a white, free-flowing 30:70 (w/w) water-in-oil (W/O) emulsion. MER3101 contains in the aqueous (disperse) phase 33, 109, or 327 µg per 0.25 mL dose of IBC (Drug Substance) and the oil (continuous) phase is comprised of MAS-1 oil vehicle.
15903269|NCT03624049|Other|Exercise|Community based exercise programs held 2-3 times per week
15903270|NCT03624049|Other|Health Class|Community based health class held 1 time per week
15903271|NCT03624036|Biological|brexucabtagene autoleucel (KTE-X19)|A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously
15903272|NCT03624036|Drug|Fludarabine|Administered intravenously
15903273|NCT03624036|Drug|Cyclophosphamide|Administered intravenously
15903274|NCT03624023|Drug|TWB-103|TWB-103 will be applied to the target ulcer wound once a week by the investigator, starting from Day 1, until wound closure is confirmed or up to 12 weekly applications
15903275|NCT03624010|Drug|Levosimendan 2.5 mg/ml Injectable Solution|A sterile 2.5 mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion
15903276|NCT03623997|Other|Iron stable isotope labeled iron(II) sulfate|Administration of oral stable isotope labels using different dosings and different regimens in women with iron deficiency anemia
15903277|NCT03623984|Drug|Gallium Dotatate|Radioguided Surgery for Pancreatic- Neuroendocrine Cancers
15903278|NCT03623971|Device|Cataract AI agent|An artificial intelligence to make comprehensive evaluation and treatment decision of different types of cataracts.
15903279|NCT03623958|Device|Image guided Video-Assisted Thoracic Surgery (VATS) resection|Image guided placement of a fiducial consisting of a needle directed placement of a T-Bar next to the target lesion in order to lead the surgeon to the lung region to be removed
15903280|NCT03623958|Procedure|Video-Assisted Thoracic Surgery|Standard of Care Video-Assisted Thoracic Surgery (VATS) resection
15903281|NCT03623945|Other|Collection of blood|Collection of blood only to look at circulating autoantibodies that recognize breast cancer proteins to potentially be used as a biosensor for identifying patients with increased risk of having breast cancer
15903282|NCT03623932|Drug|immunosuppressor/TNFalpha|Standard Treatment : immunosuppressor/TNFalpha as in standard practice
15903283|NCT03623932|Behavioral|Hypnosis|8 hypnosis group sessions during 2 months
15903284|NCT03623919|Other|FallSensing multiplayer games|"FallSensing multiplayer games is a technological solution based on an interactive (exer)game.
~Players will wear a strap on the lower limbs contaning an inertial sensor. This device enables movement identification on the characterization in real time, triggering actions in the game.
~The exercise games are based on a validated fall prevention exercise plan - the Otago Exercise Programme. The exercises were designed to promote mobility and improve muscle strength and balance."
15903285|NCT03623906|Procedure|Carbon dioxide insufflation colonoscopy|Carbon dioxide insufflation colonoscopy
15903286|NCT03623906|Procedure|Air insufflation colonoscopy|Room air insufflation colonoscopy
15903287|NCT03623893|Procedure|Contralateral exploration|Surgery eventually performed when a patent processus vaginalis or hernia exists on the other side than the side on which the child has to be operated on, will be exactly the same as the inguinal hernia repair on the 'symptomatic' side. Exploration of the contralateral side will increase anaesthesia time by 10-15 minutes.
15903288|NCT03623880|Behavioral|Unified Protocol|The unified protocol is a form of cognitive behavior therapy focused on helping the person reduce emotional distress through cognitive changes and behavioral skills. Exercises included confronting emotional-driven behaviors and mindfulness activities.
15903289|NCT03623880|Behavioral|Supportive Therapy|Supportive therapy seeks to improve self-esteem, aid the patient with problem solving, and provide structured support using empathetic listening.
15903290|NCT03623867|Drug|Secukinumab|Subject will take secukinumab once weekly in week 0-4, and once monthly till week 48
15903291|NCT03623867|Drug|Placebo|Subject will take placebo once weekly in week 0-4, and once monthly till week 48
15903292|NCT03623854|Biological|Nivolumab|Given IV
15903293|NCT03623854|Biological|Relatlimab|Given via infusion
15903294|NCT03623841|Other|Dual-task training|Participants in experimental group will do dual-task training via exer-game which combined with treadmill
15903295|NCT03623841|Other|Treadmill training|Participants in control group will do treadmill training only
15903296|NCT03623828|Drug|Apomorphine Hydrochloride 50Mg/10mL Prefilled Syringe|Product administered using an external continuous subcutaneous infusion pump.
15903297|NCT03623815|Other|transcranial direct current stimulation|"Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulatory technique that uses weak electrical current to increase (with anodal) or decrease (with cathodal) the probability of brain activity in the stimulated region. This typically has acute effects relating to cortical activity levels which last up to one hour.
~This intervention delivers 20 minutes of 2mA bipolar balanced tDCS, with anodal tDCS delivered to the left dorsolateral prefrontal cortex (DLPFC) and simultaneously cathodal tDCS delivered to the right DLPFC. In the sham condition 40 seconds of stimulation is delivered."
15903298|NCT03623802|Other|Local Movement Therapy|Loads and intensity of exercises will be increased according to participants' abilities. Modifications of exercises are made through different body positions or increasing the load. When a participant will be able to perform a certain number of repetitions and sets of a required exercise, without any compensatory movements, he/she can proceed to the next level of exercise. Breaks between exercises and sets are the same as in the integral movement therapy protocol. Protocol consists of four basic exercises, which are progressed through sessions: (I) Abdomen curl. (II) Trunk extension on roman chair. (III) Hip bridge. (IV) Side plank.
15903299|NCT03623802|Other|Integral Movement Therapy|Protocol consists of four basic exercises, which are progressed through sessions: (I) Proprioception - sitting on an unstable surface - Swiss ball, with additional tasks with legs and arms. (II) Strength - pushing task in different body positions: a) Unstable position - from single plane to multi-plane arm movements. b) Stable position - high number of repetitions - single plane movement. (III) Strength - pulling task in different body positions: a) Unstable position - from single plane to multi-plane arm movements. b) Stable position - high number of repetitions - single plane movement. (IV) Lifting and carrying the loads: a) Stoop lifting. b) Squat lifting. c) Half kneeling lifting.
15903300|NCT03623789|Drug|intravenous application of tranexamic acid|intravenous application of tranexamic acid1 g TXA before incision, followed by two boluses (1g TXA) three hours later and six hours later.
15903301|NCT03623789|Drug|Floseal hemostatic matrix|application of Floseal® on potential bleeding sites after prosthesis implantation
15903302|NCT03623789|Drug|Normal saline|Equivalent volume of saline injection before incision, followed by two boluses (1g TXA) three hours later and six hours later.
15903303|NCT03623776|Drug|JS001|JS001 was given 240 mg i.v. infusion on Day 1 of each 21-day cycle for 3 cycles.
15903304|NCT03623776|Drug|Pemetrexed|Subjects receive pemetrexed of 500 mg/m^2 administered as IV infusion on Day 1 of each 21-day cycle for 3 cycles.
15903305|NCT03623776|Drug|Carboplatin|Subjects receive carboplatin at the AUC of 5 administered as IV infusion on Day 1 of each 21-day cycle for 3 cycles.
15903306|NCT03623776|Procedure|Thoracic Surgery|Surgery will be performed at least 21 days after the last dose of neoadjuvant therapy.
15903307|NCT03623763|Diagnostic Test|Serologic tests of blood samples|Five milliliters of peripheral venous blood will be (after 8-12 hours of fasting) from each participant and will be collected into Human Tube Serum Gel - C/A for ELISA. All blood samples will be collected in August and January. Serum levels of 25(OH) VD and TNF-α, IFN-γ, IL-4 and IL-6 will be detected by ELISA technique
15903308|NCT03623750|Drug|EGFR-TK Inhibitor|Patients will commence daily oral therapy with the EGFR TKI afatinib as soon as possible, preferably on the same day as low dose cyclophosphamide. Afatinib will be prescribed according to the Summary of Product Characteristics (SmPC) of the product, and will continue in nominal 21-day cycles for as long as clinically indicated.
15924591|NCT03462173|Drug|placebo|Matching Placebo Capsule
15903309|NCT03623750|Biological|EGF-PTI|"The first day of dosing with EGF-PTI will be designated Day 1. Immunisation with EGF-PTI will commence 3 days after low dose cyclophosphamide and commencement of EGFR TKI, and will be repeated on Day 14, Day 28, Day 43, and Day 92. After the 5
~th vaccination, patients will enter a maintenance phase during which reduced dose vaccinations will be performed every 2 or 3 months in conjunction with the interval between detailed check-up of the patient. As this interval can vary between patients, the interval for maintenance vaccination can also vary between 2 and 3 months."
15903310|NCT03623750|Drug|Cyclophosphamide|Eligible patients will receive a single pre-treatment of low dose of intravenous cyclophosphamide 200 mg/m2 (Day -3).
15903311|NCT03623737|Drug|neoadjuvant chemoradiation|"Neoadjuvant chemoradiation:
~Radiation: 180cGy/fraction, once daily, 5 days a week, to a total of 4,500cGy.
~Chemotherapy: Arm A or Arm B Surgery: esophagectomy and 3-fields lymph node dissection"
15903312|NCT03623724|Behavioral|blended Cognitive-behavioral Therapy|The protocol includes ten face-to-face cognitive-behavioral sessions combined with nine online sessions based on Moodbuster self-help treatment, delivered over a period of 16 weeks. The Moodbuster includes 7 modules (introduction, psychoeducation, behavioral activation, cognitive restructuring, problem solving, exercise and relapse prevention), a calendar and the possibility of sending and receiving messages to and from therapist, respectively. The mobile phone application will be used to support the therapeutic sessions and register the ecological momentary assessments concerning mood, sleep quality, anxiety and other emotional states that will be collected in a daily basis before, during and after the treatment.
15903313|NCT03623724|Other|Treatment-As-Usual|The protocol consists in routine care that patients receive when they are diagnosed with major depression in primary care. We will not interfere with treatments delivered in TAU, but the intervention will be tracked (e.g., medication). The psychiatrist of our team will monitor possible medicine intake (stabilized throughout the trial).
15903314|NCT03623711|Drug|Escitalopram|participants take escitalopram tablets based on their severity of depression (10-20mg/day) at least for 12 weeks.
15903315|NCT03623711|Drug|Duloxetine|participants take Duloxetine capsule based on their severity of depression (60mg/day) at least for 12 weeks.
15903316|NCT03623711|Drug|Bupropion|participants take Bupropion tablets based on their severity of depression (75-300mg/day) at least for 12 weeks.
15903317|NCT03623711|Other|Healthy control|Healthy control take placebo tablets
15903318|NCT03623698|Drug|Nebulised hypertonic saline|Nebulised hypertonic saline used for a period of at least 12 months
15903319|NCT03623685|Diagnostic Test|measurement of uterocervical angle|We will measure between internal cervikal os and external cervical os. After we will draw a line between anterior uterine wall and internal cervical os. Then we will measure angle between two lines
15903320|NCT03623659|Procedure|Laser assisted hatching|After warming, blastocysts are subjected to laser assisted hatching (LAH) following the standard procedure.The LAH procedure lasts one minute per blastocyst.
15903321|NCT03623646|Drug|Chemoradiotherapy arm|Radiation Therapy in combination with Chemotherapy (Cisplatin)
15903322|NCT03623646|Drug|Immunotherapy + Radiotherapy arm|Radiation Therapy in combination with Immunotherapy drug (Durvalumab)
15903323|NCT03623633|Drug|denosumab|denosumab 60 milligrams subcutaneously every 6 months
15903324|NCT03623633|Drug|alendronate|alendronate 70 milligrams weekly
15903325|NCT03623633|Drug|raloxifene|raloxifene 60 milligrams daily
15903326|NCT03623620|Behavioral|Digital Delivery of Mindfulness-Based Cognitive Therapy|12-week program that emphasizes mindfulness and cognitive behavioral skills
15903327|NCT03623607|Other|Diabetes Survival Skills Education|Application of human factors and education principles to refine and optimize an DSSE program for delivery to inpatients with type 2 diabetes (D2Go - IN) using a table-based e-learning platform ; utilization of implementation science to inform design of implementation processes for delivery within nursing unit workflow; establishment of a D2Go program toolkit; and evaluation of the feasibility and preliminary impact of the program when delivered by nursing unit staff on medical-surgical units (MSUs) to adults with type 2 diabetes. Barriers and facilitators of the D2Go - Inpatient program's reach, effectiveness, adoption, implementation and maintenance (RE-AIM)(31) were explored
15903328|NCT03623594|Procedure|Surgical repair of the diastasis|Repair of the diastasis with a double row plication using absorbable Quill suture
15903329|NCT03623581|Biological|GB226|3mg/kg treat every 2 weeks
15903330|NCT03623568|Drug|glecaprevir/pibrentasvir tablets|12 weeks of treatment with Mavyret
15903331|NCT03623555|Behavioral|Trier Social Stress Test|"The participants are instructed to imagine having applied for their dream job and that they are now invited to a job interview. The TSST consists of three successive phases: (1) A preparation period (3min), (2) a free speech task in which the participants have to argue why they are the best candidate for the job they wish to apply for (5min), and (3) a mental arithmetic task in which participants have to sequentially subtract an odd two-digit number from an odd four-digit number (e.g., 17 from 2023; 5min). The two tasks are performed in front of a selection committee (two members), dressed in white lab coats, acting in a reserved manner and providing no facial or verbal feedback."
15903332|NCT03623555|Biological|Salivary cortisol|Saliva samples will be obtained by means of Salivette collection devices before, 10 minutes after, and 30 minutes after the beginning of the TSST
15903333|NCT03623529|Drug|LJPC-501 (angiotensin II)|Angiotensin II is a peptide hormone naturally produced by the body that regulates blood pressure via vasoconstriction and sodium reabsorption.
15903334|NCT03623529|Drug|Placebo|Placebo Arm
15903335|NCT03623503|Other|Observational study|
15903336|NCT03623490|Other|managment of oral therapy|Initial consultation with a trio oncologist / pharmacist / nurse
15903337|NCT03623477|Behavioral|Cognitive Remediation (CRT)|Study compares two configurations of cognitive training--computerized cognitive remediation versus a combination of computerized cognitive remediation and social cognition training. The cognitive remediation therapy group will complete computerized training activities in attention, memory, processing speed, problem solving, and executive functions.
15903338|NCT03623477|Behavioral|CRT+ Social Cognition Training|Study compares two configurations of cognitive training--computerized cognitive remediation versus a combination of computerized cognitive remediation and social cognition training. The combined cognitive remediation and social cognition training group will complete computerized training that target neurocognitive functions, facial affect emotion recognition and mentalizing tasks.
15903339|NCT03623464|Other|Mobile health application and Fitbit + standard of care|Mobility data will be generated using a mobile health tracker designed for smartphone devices, which allows the phone to automatically and passively (no patient input needed) capture information on the patient's activity; i.e. if the person is walking, remaining stationary, or moving at a rapid speed (eg. in a car). The app will prompt patients once daily to answer a series of questions that will collect patient reported symptoms and health status data. Physicians will be alerted to abnormal values within 24-48 hours and patients will be triggered to call their physicians immediately if the values are outside of normal parameters.
15903340|NCT03623464|Other|Standard of care|Post-operative standard of care information
15903341|NCT03623451|Drug|Chinese Medicine Formula|Chinese Medicine Formula, composed of American ginseng 10g, Poria cocos 15g, bighead atractylodes rhizome 20g, Astragalus mongholicus 30g, Crataegus pinnatifida Bunge 20g, Salvia miltiorrhiza Bge. 20g, Pericarpium Citri Reticulatae 10g will be decocted and packaged into vacuum packs by the pharmaceutical department of First Affiliated Hospital, Heilongjiang University of Chinese Medicine (140 mL/pack). Subjects will take 2 packages per day for three months.
15903342|NCT03623438|Behavioral|Self-administered acupressure group|Subjects in the self-administered acupressure group will attend an acupressure training course (2 sessions, 2 hours each) to learn self-administered acupressure, which will then be performed every night for 4 weeks.
15903343|NCT03623438|Behavioral|Sleep hygiene education (SHE) group|Subjects in the comparison group will receive sleep hygiene education (2 sessions, 2 hours each, same as the treatment group) and be reminded to follow the sleep hygiene practice daily for 4 weeks.
15903344|NCT03623425|Drug|68Ga-PSMA-11 PET|a 68GA-PSMA-11 PET exam before the a 18F-FCH PET exam
15903345|NCT03623425|Drug|18F-FCH PET|a 18F-FCH PET exam before the 68Ga-PSMA-11 PET exam
15903346|NCT03623412|Diagnostic Test|75g oral glucose tolerance test|Women with one abnormal value in the OGTT during pregnancy (minor degree of glucose intolerance) will be offered a post-partum 75g GTT (Glucose Tolerance Test), similar to that offered to women with GDM
15903347|NCT03623412|Diagnostic Test|75g GTT|post-partum GTT
15903348|NCT03623399|Procedure|low gas pressure laparoscopy|To apply different CO2 entrance and intraoperative pressures
15903349|NCT03623386|Other|PD neurofeedback|PD-neurofeedback subjects will practice motor imagery in the MRI scanner and receive neurofeedback on their performance. There will be a total of 10-12 neurofeedback sessions on two separate days. Subjects will continue practicing motor imagery at home every day throughout the study period for 4-6 weeks.
15903350|NCT03623386|Other|PD control|PD-control subjects will practice visual imagery (e.g., of scenery, objects, etc., but not of movement) in the MRI scanner and will not receive neurofeedback on their performance. Subjects will continue practicing visual imagery at home every day throughout the study period for 4-6 weeks.
15903351|NCT03623373|Drug|Bendamustine|Bendamustine will be administered at a dose of 90 mg/m^2 IV over 30 minutes on Days 1 and 2 of Cycles 1-3
15903352|NCT03623373|Drug|Rituximab|In Cycle 1, rituximab will be administered at a dose of 375 mg/m^2 IV on Day 1 or 2 at the investigator's discretion in order to reduce the risk of a first infusion reaction. Rituximab will be given on Day 1 of Cycles 1 through 6.
15903353|NCT03623373|Drug|Acalabrutinib|The capsules should be swallowed intact with water and with or without food.
15903354|NCT03623373|Drug|Cytarabine|On Days 1 and 2 of Cycles 4-6, following rituximab dosing, cytarabine will be administered IV every 12 hours for a total of 4 doses.
15903355|NCT03623373|Procedure|Leukapheresis|Until collection of ≥ 2 x 106 CD34+ stem cells / kg
15903356|NCT03623373|Procedure|Peripheral blood|-Baseline, end of Cycle 3, 4-6 weeks after Cycle 6 Day 1, and if the patient discontinues protocol therapy prior to completion of Cycle 6
15903357|NCT03623373|Procedure|Oral rinse|-Baseline
15903358|NCT03623373|Procedure|Bone marrow collection|-Bone marrow will be collected at baseline if the patient requires a marrow for staging purposes and at end of treatment if the patient requires a marrow for restaging.
15903359|NCT03623360|Diagnostic Test|Free breathing DCE-MRI|Free breathing DCE-MRI
15903360|NCT03623347|Other|TMZ and BEV induction before chemoradiotherapy|New approaches are needed for patients newly diagnosed with bulky glioblastoma (GB) and/or with severe neurological impairment that cannot benefit from first line temozolomide (TMZ)-based chemoradiotherapy.
15903361|NCT03623334|Radiation|Image-Guided Radiation Therapy|Radiotherapy to a potent tumorcidal dose
15903362|NCT03623321|Drug|Pimavanserin|• Pimavanserin 34 mg is provided as 2×17 mg tablets as single dose, once daily by mouth. Dose adjustments of pimavanserin down to 20 mg (provided as 2×10 mg tablets as a single dose, once daily by mouth) and up to 34 mg are permitted based on Investigator assessment of clinical response.
15903363|NCT03623308|Other|Fiber cereal|Whole grain and bran cereal
15903364|NCT03623295|Other|Blood sample|Blood withdrawal.
15903365|NCT03623295|Other|Questionnaire|Online questionnaire about the bleeds that patients experienced in the past.
15903366|NCT03623295|Other|MRI-imaging|MRI imaging of joints.
15903367|NCT03623295|Other|Physical examination|Physical examination of joint status.
15903368|NCT03623282|Drug|Synatura® 15 mL|All subjects will receive Synatura® 15 mL every day three times for 3 months.
15903369|NCT03623269|Procedure|posterior approach to total shoulder arthroplasty|The posterior approach to total shoulder arthroplasty approaches the patient from the back of the shoulder and spares the rotator cuff.
15903370|NCT03623256|Drug|Spinal fentanyl|25 mcg of fentanyl (0.5 mL) will be administered by intrathecal route.
15903371|NCT03623256|Drug|Spinal bupivacaine|1.25 mg of preservative-free bupivacaine 0.25% (0.5 mL) will be administered by intrathecal route.
15903372|NCT03623256|Drug|Spinal Fentanyl and Bupivacaine|1.25 mg of preservative-free bupivacaine 0.25% (0.5 mL), and 25 mcg of fentanyl (0.5 mL) will be administered by intrathecal route.
15903373|NCT03623256|Drug|Epidural fentanyl /spinal bupivacaine|1.25 mg of preservative-free bupivacaine 0.25% (0.5 mL) will be administered by intrathecal route, and 100 mcg of fentanyl (2 mL) will be administered by epidural route.
15903374|NCT03623243|Drug|Siponimod|Siponimod 2mg tablets taken once daily
15903375|NCT03623230|Procedure|Ultrasound Guided Femoral Nerve Block|Femoral nerve block will be applied post-operatively with guidance of USG and nerve stimulator
15903376|NCT03623230|Other|Dressing|Only dressing will be applied to related area to protect blindness between groups
15903379|NCT03623217|Behavioral|Qualitative interviews with participants|For the development and validation of a questionnaire.
15903380|NCT03623204|Other|Dyspnea evaluation|
15903381|NCT03623191|Other|Clinical examination|
15903382|NCT03623178|Other|Assertive Community Treatment|The intervention program is a type of very flexible community treatment. This is facilitated by a small case load ratio per health care professional (1:10). The healthcare workers are specialized in SUD treatment. The time of the intervention differs, there is no prefixed limitation but the duration of the intervention depends on the goals agreed on with the patient. The main objective of this intervention is to ensure an adherence to an addiction treatment program and establish or consolidate a stable healthcare and social network for the patient. The intervention aims to prevent service disengagement. The healthcare workers will explore specific patient needs and ensure that health and social services are better coordinated to fit their needs.
15903383|NCT03623178|Other|Treatment As Usual|The treatment as usual is the intervention given in our outpatient addictology unit. It consists of an individual treatment program at our outpatient unit with regular appointments with psychiatrists and nurses. The patient can also take part in therapeutic groups and receive help from a psychologist for a targeted program or psychotherapy. The multidisciplinary team also comprises a social worker and an occupational therapist.
15903384|NCT03623165|Device|Cordella™ Heart Failure System|The Cordella™ Heart Failure System electronically transfers communications and data from a set of medical devices in a heart failure patient's home to a database for storage, retrieval, and display to healthcare providers.
15903385|NCT03623139|Behavioral|Standard nutritional education|Routine dietary care consists of three individual consultations with a trained dietitian. The individual guidance will be in accordance with the dietary guidelines in type 2 diabetes.
15903386|NCT03623139|Behavioral|Basic carbohydrate counting|The BCC concept is a group-based program consisting of three group sessions delivered by trained dietitians.
15903387|NCT03623126|Other|Questionnaire|A questionnaire to evaluate clinical improvement and quality of life after ESSURE removal will be completed by patients at least one month after the procedure.
15903388|NCT03623113|Behavioral|BCC intervention|Structured training and education i basic carbohydrate counting principles
15903389|NCT03623113|Behavioral|ABC-ACC intervention|Structured training and education i advanced carbohydrate counting principles including the use of a automated bolus calculator carbohydrate
15903390|NCT03623113|Behavioral|Standard dietary education|Personalized individual dietary counselling based on overall meal planning, dietary guidelines and the patient's need and preferences
15903391|NCT03623100|Behavioral|Speech Production Treatment.|Speech production treatment will be delivered in two phases: Imitation and Spontaneous Production. Treatment will be provided two times weekly in 1-hour sessions, for up to 19 sessions. Every child's intervention program will target a single phoneme that was excluded from his or her phonemic inventory. Each treatment phoneme will be targeted through the production of five words that will be initially introduced to the child using a storybook reading format. Imitation treatment will continue until a child maintains 75% accurate production of the treated phoneme over two consecutive sessions (i.e. performance-based criterion) or until seven consecutive sessions are completed (i.e. time-based criterion). Spontaneous Production will continue until the child maintains either a performance-based criterion of 90% accurate production of the treated phoneme over 3 consecutive sessions, or a time-based criterion of 12 consecutive sessions.
15903392|NCT03623100|Behavioral|Speech Production + Speech Perception Treatment.|This speech treatment condition will be administered in the same way as the Speech Production treatment. The difference in conditions will be that speech treatment in this condition will last for 50 minutes rather than 60 minutes. The remaining 10 minutes of each session will involve the speech perception training. These speech perception tasks will involve previously recorded word-level productions focusing on the same phoneme that is addressed in speech production treatment in word-initial position. A variety of words produced correctly and incorrectly by adults and children will be presented in pairs and the children will have to determine if the words contain the same word-initial phoneme or two different phonemes.
15903393|NCT03623087|Drug|Cisplatin|SIMPLE
15903394|NCT03623087|Drug|Gemcitabine|SIMPLE
15903395|NCT03623087|Drug|Etoposide (VP-16)|SIMPLE
15903396|NCT03623087|Device|Ifosfamide|SIMPLE
15903397|NCT03623087|Drug|Dexamethasone|SIMPLE
15903398|NCT03623087|Drug|L-asparaginase|SIMPLE
15903399|NCT03623074|Device|Novel spectacle lens design|Use of lenses may reduce the rate of progression of juvenile myopia
15903400|NCT03623074|Device|Spectacle lenses|Use of lenses may reduce the rate of progression of juvenile myopia
15903401|NCT03623061|Diagnostic Test|F-Point|F-Point (point of care in vitro diagnostic device for measuring plasma fibrinogen concentration)
15903402|NCT03623048|Other|chlorhexidine|antibacterial and anti-inflammatory mouthwash
15903403|NCT03623048|Other|saline|anti-inflammatory cleansing mouthwash
15903404|NCT03623048|Other|Propolis extract|antibacterial mouthwash
15903405|NCT03623048|Other|pomegranate extract|antibacterial mouthwash
15903406|NCT03623022|Drug|Clinical Center Reference Endotoxin (CCRE)|subjects will undergo an exposure to inhaled endotoxin through a nebulizer for approximately 10 minutes.
15903407|NCT03623022|Drug|Normal saline|subjects will undergo an exposure to inhaled normal saline through a nebulizer for approximately 10 minutes
15903408|NCT03623009|Behavioral|An article meant to trigger certain psychosocial behaviors|An article meant to trigger certain psychosocial behaviors is administered to the intervention arm prior to laparoscopic skills assessment.
15903409|NCT03623009|Behavioral|a neutral article|The control arm will receive a neutral article prior to completing the assessment.
15903410|NCT03622983|Other|collection of sample and data|Recovery of surgical waste during surgery planned in the current care and clinical data collection
15903411|NCT03622970|Device|VGBT with Nintendo® Wii and LMC games|Nintendo Wii and LMC games will be used for upper limb rehabilitation in Cerebral Palsy. The games are tennis and boxing for Nintendo Wii, Leapball and CatchApet for LMC.
15903412|NCT03622970|Behavioral|NDT-based upper limb rehabilitation|NDT-based upper limb rehabilitation includes using real materials (clothes, spoons, pencils, buttons, rope, etc.) such as getting dressed and eating etc. Also, It will practised with the materials such as velcro cylinders, skill cubes, exercise bands, screw sets, therapeutic putty, and tripled coordination tools.
15903413|NCT03622944|Procedure|Muscle Energy Technic|post isometric relaxation technics were applied to levator scapulae, trapezius, pectoralis muscles three sessions per week, totally six weeks.
15903414|NCT03622944|Procedure|Deep Friction Massage|deep friction massage was applied to cervical region included tendons, muscles and soft tissue.
15903415|NCT03622944|Procedure|Exercise|spinal stabilization exercise were applied three sessions in a week totally six weeks.
15903416|NCT03622931|Drug|Standard chemotherapy|Chemotherapy
15903417|NCT03622931|Drug|Romiplostim|
15903418|NCT03622931|Drug|Placebos|
15903419|NCT03622918|Drug|colistin and rifampin combination therapy|Colistin (100 mg, colistin sodium methanesulfonate, SCD Pharm., Seoul, Korea) will be intravenously administered with 100 mL of normal saline with 8 hours interval. Rifampin (600 mg, rifampin, Yuhan, Seoul, Korea) will be orally administered daily. Treatment should be maintained daily administration for at least 7 days and up to 28 days. Duration of antibiotics treatment will be determined through discussion by pulmonology and infection specialist.
15903420|NCT03622918|Drug|colistin monotherapy|. Colistin (100 mg, colistin sodium methanesulfonate, SCD Pharm., Seoul, Korea) will be intravenously administered with 100 mL of normal saline with 8 hours interval. Treatment should be maintained daily administration for at least 7 days and up to 28 days. Duration of antibiotics treatment wil be determined through discussion by pulmonology and infection specialist .
15903421|NCT03622905|Device|DBS-f On|Deep Brain Stimulation of the fornix
15903422|NCT03622905|Device|DBS Off|Deep Brain Stimulation of the fornix turned off
15903423|NCT03622879|Behavioral|MT|A customised angle-adjustable frame with a mirror board (60 × 90 cm) will be used. All subjects are instructed to perform hip flexion/abduction, knee flexion/extension and ankle dorsiflexion/plantarflexion on the intact-limb during a 15 minutes period.
15903424|NCT03622879|Device|TENS|TENS will be delivered to the common peroneal nerve of the paretic leg. The stimulation frequency will be 100Hz and with an intensity just below the motor threshold.
15903425|NCT03622879|Behavioral|Lower-limb task-oriented training|The lower-limb task-oriented training comprises 6 exercises, namely stepping up and down, heel lift a dorsiflexed position, partial squatting, kicking a ball with alternate legs, gait re-education and transition training. Each exercise last for 10 minutes
15903426|NCT03622866|Device|Ultra-high pulse width stimulation|Algovita Spinal Cord Stimulation System with associated components
15903427|NCT03622866|Device|Traditional pulse width stimulation|Algovita Spinal Cord Stimulation System with associated components
15903428|NCT03622853|Drug|Steroid (shincort)|intraarticular shincort 40mg / 4ml mixed with 2% xylocaine and Normal saline
15903429|NCT03622840|Behavioral|Cognitive Remediation|Weekly 30-45mins Cognitive Remediation Sessions over 11 weeks
15903430|NCT03622827|Combination Product|Chemoradiotherapy+ Endostar|"Chemoradiotherapy with Endostar：
~Chemoradiotherapy: pelvic radiotherapy starts 2-3 weeks after surgery. Intensity modulated radiotherapy (IMRT) is given five fractions per week at 1.8-2 Gy/fraction/day with total dose summed up to 45-50Gy. The external beam radiotherapy should be completed within 6 weeks.
~Concurrent chemotherapy is consisted of cisplatin (75 mg/m2, day 1-3) and 5-fluorouracil (5-FU; 1000mg/m2/day, civ, day 1-4) for 2 cycles every 3 weeks.
~Endostar: recombinant human endostatin (15mg/m2/d, civ, d1-7) is given 3 days before the concurrent chemoradiotherapy for 2 cycles every 3 weeks."
15903431|NCT03622814|Behavioral|Partners at Meals|The focus of the intervention is to facilitate meals using knowledge of the person with dementia's past history and lifelong preferences as well as their stage of disease, altering the behavior of the caregiver at meals to ameliorate dysfunctional behaviors, and altering the environment to make it more focused on the process of meals.
15903432|NCT03622814|Behavioral|Enhanced Usual Condition|Enhanced Usual Condition (EUC) Staff and volunteers at the EUC sites will receive training in communication between family and friends of the person with dementia. Following the general model of the Savvy Caregiver (Hepburn), communication training will occur every six months in these two sites. Families will be trained by project staff to record three meals including behavior at home each month. The Project Manager will attend the monthly support group for family members about communication. The administrator of the EUC RCC will be interviewed every 6 months the project is in place.
15903433|NCT03622801|Drug|Iopromide (Ultravist, BAY86-4877)|Patients who have received Iopromide (iodine concentrations of 300 mg/mL or 370 mg/mL) either intra-venously or intra-arterially.
15903434|NCT03622788|Biological|Anti-Thymocyte Globulin|Given IV
15903435|NCT03622788|Drug|Cyclophosphamide|Given IV
15903436|NCT03622788|Biological|Cytokine-treated Veto Cells|Given IV
15903437|NCT03622788|Drug|Fludarabine|Given IV
15903438|NCT03622788|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo PBSCT
15903439|NCT03622788|Radiation|Total-Body Irradiation|Undergo TBI
15903440|NCT03622775|Biological|Daratumumab|Given IV
15903441|NCT03622762|Drug|green tea extract|Capsules of green tea extract, 400 mg twice a day, fasting
15903442|NCT03622762|Drug|Placebo|Placebo capsules, 400 mg twice daily fasting
15903443|NCT03622749|Device|Transcranial Magnetic Stimulation (TMS)|Non-Invasive neuromodulation
15903444|NCT03622710|Other|Rehabilitation therapy|Subjects are trained to walk overground (control) or over WTDS (experimental) for 5 days/week over 4 week. Then they will be monthly follow-up for fall data.
15903446|NCT03622684|Behavioral|Muscle relaxation according to Jacobson|
15903447|NCT03622671|Procedure|Skeletonized LIMA|Standard CABG - no different form any other procedure of this type except LIMA will be skeletonized without opening the pleura
15903448|NCT03622671|Procedure|Pedicled LIMA|Standard CABG - no different form any other procedure of this type except LIMA will be taken down as a pedicled graft with opening the pleura
15903449|NCT03622658|Biological|Placebo|Placebo solution for subcutaneous injection.
15903450|NCT03622658|Biological|Namilumab|Namilumab solution for subcutaneous injection
15903451|NCT03622645|Device|Assessment of Range of Motion with Leap Motion sensor|An ROM measurement method called as HandROM by us will be developed with leap motion sensor
15903452|NCT03622619|Other|Optimel Antibacterial Manuka+ Dry Eye Drops|Leptospermum sp Honey 165mg/g
15903453|NCT03622619|Other|Systane Ultra Lubricating Eye Drops|Polyethylene glycol 400 0.4% and propylene glycol 0.3%
15903454|NCT03622606|Diagnostic Test|Right Language screening test (R-LAST)|Validation of the Right Language screening test in acute and subacute phase of right stroke
15903458|NCT03622580|Drug|Aflibercept|Aflibercept will be administered by intravitreal (IVT) injection into the study eye once every 8 weeks (Q8W).
15903459|NCT03622580|Drug|Faricimab|Faricimab will be administered by IVT injection into the study eye either once every 8 weeks (Q8W) in arm A or as specified in the protocol in arm B.
15903460|NCT03622580|Procedure|Sham Procedure|The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in all three treatments arms at applicable clinic visits to maintain masking among treatment arms.
15903461|NCT03622567|Behavioral|Smartphone push notifications|The purpose of this study is to assess how smartphone push notifications can impact the overall score, accuracy and reaction time of participants using the Brain Power Score application (app). Push notification quantity will be varied and counter-balanced.
15903462|NCT03622554|Other|Adapted Physical Activity (APA)|12 APA sessions of 60 minutes
15903463|NCT03622554|Other|Therapeutic Patient Education (ETP)|Personalized ETP with 3 group sessions (1h30) and one at the end of the course (1h) and educational follow-up by phone at 3, 6 and 12 months
15903464|NCT03622541|Drug|Sorafenib 200mg|Sorafenib is a multi-kinase inhibitor which is FDA approved for the treatment of metastatic hepatocellular and renal cell carcinomas.
15903465|NCT03622528|Radiation|Chest CT scan|Standard dose chest CT scan
15903466|NCT03622515|Combination Product|Anesthesia level and cerebral perfusion pressure|Anesthetic dose and blood pressure
15903467|NCT03622502|Drug|Dexmedetomidine|Dexmedetomidine 0.5mcg/kg was infused over 10 min before end of the surgery
15903468|NCT03622502|Drug|Remifentanil|Remifentanil was maintained at predetermined effect-site concentration during the periextubation period (initial concentration: 2.0 ng/ml)
15903469|NCT03622502|Drug|Normal saline|Normal saline was infused over 10 min before end of the surgery
15903470|NCT03622489|Drug|Acetaminophen|mentioned above
15903471|NCT03622489|Drug|Ibuprofen 400 mg|mentioned above
15903472|NCT03622489|Drug|Dipyrone|mentioned above
15903473|NCT03622489|Drug|Tramadol|mentioned above
15903474|NCT03622489|Drug|Morphine|mentioned above
15903475|NCT03622489|Drug|Tramal|mentioned above
15903476|NCT03622476|Drug|concentrated FVIII|Intervention if the assessment considers that the treatment is inadequate
15903477|NCT03622463|Drug|Antroquinonol|Antroquinonol will be provided as a capsule-shaped which contain 50 mg Antroquinonol.
15903478|NCT03622463|Other|Placebo|The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects
15903479|NCT03622450|Drug|Colistin|Polymyxins are bactericidal drugs that bind to lipopolysaccharides (LPS) and phospholipids in the outer cell membrane of gram-negative bacteria.
15903480|NCT03622450|Drug|Carbapenem + Aminoglycoside/ Quinolone|Dual antipseudomonal given as IV for ventilator associated pneumonia for patients with Multi-drug resistant bacteria risk factors
15903481|NCT03622437|Behavioral|Patient-led follow-up|"Patient-education, with information about signs of recurrent disease (alarm-symptoms), potential late effects, and how these can be managed.
~The patients are instructed to contact a specialist nurse in case of alarm-symptoms, concerns or other problems related to the cancer disease throughout the entire follow-up period. The specialist nurse responds to the referrals, according to a standardized algorithm.
~In addition, all patients receive:
~CEA and CT of the chest, abdomen and pelvis at 1 and 3 years after surgery
~perioperative clean colon colonoscopy, and then every 5 years until the age of 75 years
~Only for patients with a stoma:
~- access to stoma care by specialist nurses"
15903482|NCT03622437|Other|Standard follow-up|"Patients with sphincter-preserving resection:
~- outpatient visits incl. rectoscopy at 6, 12, 18, 24 and 36 months
~Patients with rectal amputation and a permanent stoma:
~outpatient visits at 3, 12 and 36 months
~access to stoma care by specialist nurses
~All patients:
~CEA and CT of the chest, abdomen and pelvis at 1 and 3 years after surgery
~perioperative clean colon colonoscopy, and then every 5 years until the age of 75 years"
15903483|NCT03622424|Device|Gelesis200|Gelesis200: Three (3)Gelesis200 capsules (2.10 g) three (3) times per day (i.e., breakfast, lunch, and dinner)
15903484|NCT03622424|Device|Placebo|Placebo: Three (3)placebo capsules three (3) times per day (i.e., breakfast, lunch, and dinner)
15903485|NCT03622424|Device|Gelesis200 and Placebo|Placebo and Gelesis200: Three (3) placebo capsules at breakfast,and three (3) Gelesis200 capsules (2.10 g)two (2) times per day (i.e., lunch and dinner)
15903486|NCT03622411|Device|speech app|language exercises provided by the speech therapist in hospital + independent practice of language exercises via a tablet and speech app
15903487|NCT03622411|Device|brain games|language exercises provided by the speech therapist in hospital + independent recreational tablet use via brain games
15903488|NCT03622411|Behavioral|aphasia therapy|language exercises provided by the speech therapist in hospital
15903489|NCT03622398|Procedure|Total knee arthroplasty with HXLPE liner|Replacing arthritic knee with a metal device, and using a highly cross-linked polyethylene(HXLPE) liner in between metallic surfaces.
15903490|NCT03622398|Procedure|Total knee arthroplasty with conventional polyethylene liner|Replacing arthritic knee with a metal device, and using a conventional polyethylene liner in between metallic surfaces.
15903491|NCT03622385|Other|DNA Methylation|No intervention will be performed. Blood and tissue samples will be analyzed for biomarkers that may be used to develop a diagnostic panel for early detection and diagnosis of high grade serous epithelial ovarian cancer.
15926164|NCT03449108|Biological|Aldesleukin|Given IV
15903492|NCT03622372|Procedure|Operative repair of Zone 2 FDP tendon lacerations|Zone 2 tendon laceration(s) will be surgically repaired either using the experimental device or the active comparator
15903493|NCT03622372|Device|CoNextions TR Implant System|The CoNextions TR Implant System will be used to repair Zone 2 FDP tendon laceration(s).
15903494|NCT03622372|Device|4-strand locked cruciate repair|A 4-strand locked cruciate repair utilizing either 3.0 or 4.0 prolene suture will be used to repair Zone 2 FDP tendon laceration(s).
15903495|NCT03622359|Diagnostic Test|SPECT/CT perfusion imaging|Subjects will receive a standard clinical dose of a radionuclide for perfusion imaging of the lower extremities before and after revascularization procedures.
15903496|NCT03622359|Diagnostic Test|PET/CT perfusion imaging|Subjects will receive a standard clinical dose of a radionuclide for perfusion imaging of the lower extremities before and after revascularization procedures.
15903497|NCT03622346|Procedure|Semi-constrained total knee arthroplasty|Semi-constrained total knee arthroplasty
15903498|NCT03622333|Genetic|Research of constitutional genetic alterations|Tumor DNA extraction Blood sample and constitutional DNA extraction CGH-array, Exome sequencing Bio-informatic analysis
15903499|NCT03622320|Other|Blood sample|Blood sample for fasting blood sugar (FBS), High density lipoproteins (HDL), Triglycerides (TG) ,HOMA-IR, serum leptin
15903500|NCT03622307|Device|Subcutaneous ICD Therapy Combined with VT Ablation|S-ICD implantation and VT ablation/substrate modification among patients with a secondary prevention indication for an ICD
15903501|NCT03622294|Device|Bella Blankets protective coverlets|Bella Blankets protective coverlets is a Class II 510(k) Cleared (2008) single-use, adhering, non-woven fabric sheet applied to the mammography equipment receptor plate to provide a more comfortable mammogram.
15903502|NCT03622281|Other|quality improvement intervention using artificial intelligence|Colonoscopists received performance measure monitoring and feedback
15903503|NCT03622255|Procedure|MINST|Minimally invasive non-surgical technique (MINST) for the treatment of intrabony defects has been compared with minimally invasive surgical treatment of these defects and has shown to achieve similar beneficial clinical results. In this study MINST will be used as the control treatment.
15903504|NCT03622255|Procedure|MINST with EMD|Enamel matrix derivative (EMD) has been widely used in the surgical treatment of periodontal intrabony defects, using a minimally invasive surgical technique (MINST). Recent studies have suggested that this product could also be used in the non-surgical treatment of intrabony defects using a minimally invasive technique with very good results. This study will evaluate the effect of enamel matrix derivative in the non-surgical treatment of periodontal intrabony defects when a minimally invasive technique is used. Besides clinical measurements, radiographic analysis will also be performed to evaluate the treatment results.
15903505|NCT03622242|Device|Pain threshold index|In pain threshold index monitor, monitor patients' pain threshold index based on electroencephalography and adjust infusion rate of remifentanil and propofol according to pain threshold index
15903506|NCT03622242|Device|Wavelet index|In wavelet index monitor, monitor patients' wavelet index based on electroencephalography as an indicator of depth of anesthesia and adjust infusion rate of propofol according to wavelet index
15903507|NCT03622229|Diagnostic Test|Histologic evaluation|Samples collected by EUS-FNB without ROSE will be processed as histologic samples
15903508|NCT03622216|Drug|Bradanicline|Three different doses over the course of the study
15903509|NCT03622216|Drug|Placebo|Matching placebo for Bradanicline
15903510|NCT03622203|Device|Biofreedom|Use of Biofreedom in real life patients
15903511|NCT03622177|Procedure|biopsie|Additional colorectal mucosal biopsies during rectoscopy or colonoscopy
15903512|NCT03622177|Biological|blood drawn|Additional blood drawn by venepuncture
15903513|NCT03622164|Radiation|Radiotherapy to ipsilateral neck lymphatics and tumor bed (radiotherapy to one side of the neck)|CTV54 includes only the ipsilateral neck, including levels 2-4 plus levels 1 and/or 5 as clinically indicated.
15903514|NCT03622164|Radiation|Radiotherapy to the bilateral neck lymphatics and tumor bed (radiotherapy to both sides of the neck)|CTV54 includes the entire surgical bed, including bilateral neck lymphatics at risk of harboring microscopic disease
15903515|NCT03622151|Other|Primer la Llar program|Housing First model: permanent housing without previous requirements such as abstinence, sobriety or compliance with treatment.
15903516|NCT03622138|Other|Impact|Impact is an easy to use, cost- and time-efficient technology platform that is capable of (a) gathering relevant process and outcomes data in a feasible way within real-world service settings; (b) producing real-time analytics (e.g., graphical displays) and meaningful reports at the provider, service setting, and broader levels (e.g., state-wide); and (c) linking data analytics to continuous quality improvement (CQI) feedback to help providers achieve best practices and targeted youth outcomes.
15903517|NCT03622125|Diagnostic Test|Vital signs|Axillary temperature sampling, at the site of the scorpion sting and the contralateral site with infrared thermometer, and heart rate, respiratory rate and blood pressure on admission, 30 minutes after applying the vial and the medical discharge
15903518|NCT03622112|Drug|AZD7594 DPI 55μg/50μg.|A non-steroidal and selective modulator of the GR.
15903519|NCT03622112|Drug|AZD7594 DPI 99 µg/90 µg|A non-steroidal and selective modulator of the GR.
15903520|NCT03622112|Drug|AZD7594 DPI 198 µg/180 µg|A non-steroidal and selective modulator of the GR.
15903521|NCT03622112|Drug|AZD7594 DPI 396 µg/360 µg once daily.|A non-steroidal and selective modulator of the GR.
15903522|NCT03622112|Drug|AZD7594 DPI 792 µg/720 µg|A non-steroidal and selective modulator of the GR.
15903523|NCT03622112|Drug|Placebo for AZD7594 once daily.|Placebo for AZD7594
15903524|NCT03622112|Drug|FF 100 µg once daily (open-label)|Fluticasone furoate
15903525|NCT03622099|Drug|Normal Saline Flush, 0.9% Injectable Solution|As a routine work in adult critical care unit at Menoufia University hospital for patients with circulatory failure, A 100 ml bolus of Normal Saline Flush, 0.9% Injectable Solution was given to the patient over 1 minute through a central venous catheter or jugular cannula. For prediction of responders, echocardiographic parameters measured followed by infusion of the remaining 400 ml of Normal Saline Flush, 0.9% Injectable Solution at a constant rate over 10 minutes then echocardiographic parameters measured again to detect the patient response.
15903526|NCT03622086|Other|Foundations of Fitness Program|The Foundations of Fitness Program is a 12 week, bi-weekly community intensive lifestyle program which focuses on healthy diet, daily physical activity, self-esteem and support for individual and family behavior change, components supported by USPSTF evidence review. Class sessions, which involve both parent/caregiver and child will include structured fitness activities, hands on nutrition, cooking, shopping and meal planning and facilitated discussions about goal setting, self-monitoring, stimulus control and healthy homes and families. Content will be offered in a context that supports self-esteem and behavior change. The program was developed by the Carter Community Building Association (CCBA) in collaboration with the Dartmouth-Hitchcock Weight & Wellness Center research core.
15903527|NCT03622073|Other|Misoprostol treatment by Midwife|Medical management of incomplete abortion
15903528|NCT03622073|Other|Misoprostol treatment by Doctor|Medical management of incomplete abortion
15903529|NCT03622060|Drug|Nitroglycerin|200 microgram intraarterial nicardipine and 500 microgram nitroglycerin administered before sheath removal
15903530|NCT03622047|Drug|Dexmedetomidine ropivacaine|Observing the effect of 0.5 μ g / ml sufentanil+ 0.1 % ropivacaine with 2 hours after fetal delivery, and the patients leave the delivery room without abnormality.
15903531|NCT03622047|Drug|No analgesia labor|No analgesia labor control group
15903532|NCT03622034|Other|posterior condylar offset measurement|the tangent to the medial tibial plateau is considered to be the proximal reference line. This is the line connecting the highest anterior and posterior points of the medial plateau. The second reference is the axis of the tibia, defined as a line through the middle of the shaft at 10 and 20 cm. The angle between these two lines is the tibial slope
15903533|NCT03622021|Drug|AK111 or Placebo|All the subjects in each cohort will be randomized in a 3:1 ratio to receive either AK111 or Placebo.
15903534|NCT03622008|Drug|FEP-TAZ 4 g|FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) IV treatments as a q8h infusion (90 min) regimen for 10 days
15903535|NCT03622008|Other|Placebo|Placebo IV
15903536|NCT03621995|Other|Malondialdehyde and Catalase level measurement|Malondialdehyde and Catalase level measurement by colorimetric method
15903539|NCT03621969|Other|Physical exam and medical history|This will be completed by a medical doctor on the research team
15903540|NCT03621969|Diagnostic Test|Assessments|One assessment in Phase I, and three assessments in Phase II (baseline, and following each 2 week active study period)
15903541|NCT03621969|Device|Patient Instruction and use of Device (RePlay)|"providing measurable upper extremity movement, control, and coordination feedback for patients, therapists, and physicians
~improving assessment and evaluation of patients involved in future interventional studies,
~producing a dynamic, responsive, inexpensive physical therapy system that can be used in the comfort of the participants' own home."
15903542|NCT03621956|Procedure|Umbilical Cord Milking|At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 15-20 seconds.
15903543|NCT03621956|Procedure|Early Cord Clamping|The umbilical cord is clamped within 30 seconds of delivery.
15903544|NCT03621943|Procedure|Umbilical Cord Milking|At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before the cord is clamped. This procedure infuses a placental transfusion of blood into the infant and can be done in 15-20 seconds.
15903545|NCT03621943|Procedure|Early Cord Clamping|The umbilical cord is clamped within 30 seconds of delivery.
15903546|NCT03621917|Device|Near-infrared spectroscopy reading|Non-invasive readings will be taken from forehead with near-infrared spectroscopy
15903547|NCT03621904|Drug|Hormonal Antineoplastics|Hormonal therapy used for treatment in endometrial cancer patients
15903548|NCT03621878|Other|Neural mobilization exercises -Tensioner technique|Exercise aiming to lengthen the neural structure using more than one joint.
15903549|NCT03621878|Other|Neural mobilization exercises -Slider technique|Exercise aiming to slide/glide the neural structure using more than one joint.
15903550|NCT03621878|Other|Transcutaneous Electrical Nerve Stimulation (TENS)|Electrotherapy device aiming to decrease patient's symptoms.
15903551|NCT03621865|Dietary Supplement|TG|Turmipure GOLD™ 30% curcuminoids (300 mg)
15903552|NCT03621865|Dietary Supplement|STE|Standard turmeric powder extract 95% curcuminoids (1500 mg)
15903553|NCT03621865|Dietary Supplement|NOV|Novasol® Liquid micellar formulation 6% curcuminoids (1000 mg)
15903554|NCT03621865|Dietary Supplement|PHYT|Meriva® Turmeric Phytosome formulation 20% curcuminoids (1000 mg)
15903555|NCT03621865|Dietary Supplement|TEP|Turmeric extract C3 complex® 95% curcuminoids (1500mg) + BioPerine® 95% piperine (15 mg)
15903556|NCT03621852|Device|Endoultrasound guided FNB|EUS FNB with Aquire TM device
15903557|NCT03621826|Other|Questionnaire/Interview|A convenience sample of patients/parents and stakeholders will be asked to participate in a survey and/or interview to evaluate barriers to care in sickle cell.
15903558|NCT03621813|Behavioral|Exercise Rehabilitation|This training is designed to improve fitness, target the major muscle groups for strength, and to improve balance. Aerobic exercise of walking on a treadmill will be performed. Thera-Bands will be used for resistance exercise for the lower and upper body. Balance program includes core exercises (stepping, weight shifts, etc.) and other progressive exercises.
15903559|NCT03621813|Other|Control|Participants are instructed to maintain current activity level and are monitored for changes.
15903560|NCT03621800|Other|Menthol popsicle|The menthol popsicle composed of 0.05% menthol, 0.05% saccharin, 20ml ultrafiltered water and 2% cereal alcohol. The menthol popsicle was supported by a stick, allowing patients to taste more comfortably, with autonomy and safety
15903561|NCT03621787|Device|Implant insertion device|Device designed to assist healthcare providers in administering subcutaneous implants safely and accurately.
15903562|NCT03621774|Behavioral|Mobile-assisted CBT-informed Skills Training|mCBTn combines the CBT-informed components that target defeatist attitudes from Cognitive Behavioral Social Skills Training (CBSST) group skills training and mobile smartphone interventions from our prior clinical trials research.
15903737|NCT03620331|Procedure|Surgery without a previous non-surgical approach|Non-surgical phase not done prior to the surgical treatment of peri-implantitis
15903738|NCT03620318|Drug|Crenolanib besylate|
15903563|NCT03621774|Behavioral|Supportive Contact|The SC intervention will provide the same amount of group and mobile device contact as the mCBTn condition. Participants will be carrying a phone but will not have access to the CBT-informed app. Group contact sessions will be semi-structured and consist of trouble-shooting device use and check-in about symptoms and potential crisis management, followed by a flexible discussion involving psychoeducation, instructions for accessing community crisis lines and related community resources, empathy, and non-directive reinforcement of health, coping, and symptom management behaviors that grow out of group discussions, with only minimal group leader guidance.
15903564|NCT03621761|Behavioral|Telephone-based Cognitive Behavioral Therapy|"Cognitive behavioral therapy (CBT) is a behavioral-based treatment that promotes effective self-management skills, including adaptive thought processes and behaviors (i.e. coping skills). CBT also commonly teaches goal-setting and behavioral activation strategies for engaging in physical, social, and other valued activities in the context of fatigue."
15903565|NCT03621761|Drug|Modafinil|Modafinil is a safe, well-tolerated and effective wake-promoting agent (oral medication) that is FDA-approved for the treatment of fatigue related to sleep disorders. Modafinil is also one of the most commonly used medications for multiple sclerosis related fatigue in clinical practice, with doses ranging from 50 - 400 mg per day, in divided doses (once to twice daily).
15903566|NCT03621748|Procedure|Awake Anesthesia Protocol|Awake is defined as the patient being awake with electrical brain stimulation mapping during the critical portions of the procedure.
15903567|NCT03621748|Procedure|Non-awake Anesthesia Protocol|Non-awake is general anesthesia as per convention with intubation.
15903570|NCT03621722|Other|Elequil Aromatabs|There will be a variety of different Aromatabs such as orange/peppermint or lavender
15903580|NCT03621683|Procedure|blood rich plasma platelets|Injection of blood rich platelet into the ovaries.
15903581|NCT03621683|Dietary Supplement|Antioxidant therapy|"Antioxidants:
~Q10, DHEA, Vitamina E, Vitamin C, Omega 3"
15903590|NCT03621657|Drug|Low Dose FMT Capsule DE|5 FMT Capsule DE along with antibiotic; followed by five capsules FMT Capsule DE x 7 days post-antibiotic course.
15903591|NCT03621657|Drug|Single Dose FMT Capsule DE|30 pill FMT Capsule DE treatment x 1, 48-72 hours following completion of antibiotic treatment.
15903592|NCT03621657|Drug|Placebo oral capsule|Five capsules per day along with antibiotic; followed by five capsules per day for seven days post-antibiotic treatment.
15903593|NCT03621644|Radiation|Stereotactic MRI-guided On-table Adaptive Radiation Therapy|Radiation therapy will be delivered with an integrated magnetic resonance imaging (MRI)-guided radiotherapy delivery system (ViewRay MRIdian or MRIdian Linac). The prescribed dose will be 50 Gray (Gy) in 5 fractions. Stereotactic body radiotherapy (SBRT) fractions will be delivered at least twice per week, and with at least 18 hours between fractions. Each participant will be aligned in the treatment system with MRI image-guidance. On-table adaptive re-planning will be used when clinically indicated. In all patients, real-time MRI imaging will be used throughout treatment delivery to monitor the target location and control the radiation beam as necessary.
15903594|NCT03621631|Behavioral|Optimized Tai Chi intervention|Optimized Tai Chi intervention
15903595|NCT03621631|Behavioral|Traditional Tai Chi intervention|Traditional Tai Chi intervention
15903596|NCT03621618|Diagnostic Test|dobutamine|evaluation of effects of dobutamine on dynamic arterial elastance in cardiac failure
15903597|NCT03621618|Diagnostic Test|norepinephrine|evaluation of effects of norepinephrine on dynamic arterial elastance in sepsis
15903598|NCT03621605|Biological|VIB9600|"Part 1 (SAD): IV infusion (30, 100, 200, 300 or 1000 mg) or SC injection (300 mg) on Day 1.
~Part 2 (MAD): IV infusion (100 and 300 mg) every 2 weeks for 4 weeks (3 doses total; Days 1, 15 and 29)."
15903599|NCT03621605|Drug|Placebos|Placebo administered by slow IV infusion or SC injection.
15903600|NCT03621592|Device|Cutimed® Sorbact®|Dialkylcarbomoyl chloride based wound dressing
15903601|NCT03621592|Device|Acticoat®|Silver impregnated contact layer dressing
15903602|NCT03621579|Procedure|cataract surgery|To measure the RNFLT and CMT in congenital cataracts before and after the cataract extraction with IOL implantation surgery
15903603|NCT03621566|Other|No intervention|Routine care (registry)
15903604|NCT03621553|Drug|Ergocalciferol|Vitamin D2 50,000 units
15903605|NCT03621553|Drug|Placebo|Sugar pill manufactured to mimic ergocalciferol 50,000 units
15903606|NCT03621553|Drug|Calcium Citrate with Vitamin D2|To meet the recommended minimum daily dietary requirements
15903607|NCT03621540|Device|active tDCS|Using the NeuroConn Plus tDCS device, 2 mA anodal tDCS will be applied to the right dorsolateral prefrontal cortex (F4). 15 s fade in and fade out. Total stimulation time of 1365 s. Cathode over contralateral deltoid muscle.
15903608|NCT03621540|Device|sham tDCS|Sham mode of the NeuroConn Plus tDCS device with 2 mA stimulation for 45 s at the beginning. Anode over right dorsolateral prefrontal cortex (F4), Cathode over contralateral deltoid muscle. After that, only continuous impedance checking is performed.
15903609|NCT03621540|Behavioral|Adaptive working memory training|Adaptive spatial n-back training.
15903610|NCT03621527|Other|anesthesia combined with intravenous analgesia by remifentanil|intravenous analgesia by remifentanil is provided and adapted to the patients' needs during the whole procedure
15903611|NCT03621527|Other|fluoroscopy-guided epidural anesthesia|Identification of the epidural space using fluoroscopy and the injection of a small quantity of contrast medium or air. An additional, anesthesia combined with intravenous analgesia by remifentanil is provided and adapted to the patients needs during the whole procedure
15903612|NCT03621514|Procedure|painless indwelling catheter|Catheterization after anesthesia (14 F Foley's urinary catheter), the patient was removed before the anesthesia was awakened and the catheter was removed(Fully lubricate the anterior end of the catheter with a lidocaine ointment 2.5g before catheterization).
15903613|NCT03621514|Procedure|indwelling catheter|The patients underwent catheterization(14 F Foley's catheter) after anesthesia,and the catheter was indwelled(Fully lubricate the anterior end of the catheter with a lidocaine ointment 2.5g before catheterization). The patient was routinely removed for 24 to 72 hours after surgery.
15903614|NCT03621501|Device|Percutaneous coronary intervention|At the index procedure, the culprit lesion (cause of complaints/acute coronary syndrome) will be treated according to standard of care with a Biotronik Orsiro DES (Sirolimus-Eluting stent). If there are additional significant lesions besides the culprit lesion, patients will be randomized to direct complete revascularization or staged complete revascularization. In the direct complete revascularization group all lesions will be treated during the index procedure. In the staged complete revascularization group, only the culprit lesion will be treated during the index procedure. The remaining significant lesions will be treated later but within six weeks after the index procedure. In both arms the additional lesions will also be treated with Biotronik Orsiro DES (Sirolimus-Eluting stent).
15903615|NCT03621488|Other|Efficacy of Behavioral Self-Activation with virtual reality|Efficacy of Behavioral Self-Activation with virtual reality
15903616|NCT03621488|Other|Efficacy of Behavioral Self-Activation without virtual reality|Efficacy of Behavioral Self-Activation without virtual reality
15903617|NCT03621475|Device|Novel restraint|Use of a novel arm restraint
15903618|NCT03621462|Device|Artificial Intelligence Dermatology Assistant (AIDA™)|The Artificial Intelligence Dermatology Assistant (AIDA™) collects conventional demoscopic images and images at various spectral bands. Following image acquisition, the AIDA™ software presents users with (1) similar lesion images from the International Skin Imaging Collaboration archive, (2) Hypodermoscopy™ images, and (3) images providing an indication of lesion depth, based on the spectral data.
15903619|NCT03621436|Device|TRVD Therapy|A catheter-mounted expandable flow pump is to be deployed in a transfemoral venous catheterization procedure. Once in place, renal venous pressure is reduced to a pre-selected physiologic target pressure and kept there for up to 24 hours. After termination of TRVD therapy, the device is removed.
15903739|NCT03620305|Other|Description of treatment of septic pseudarthrosis|description of chirurgical 2 steps management of septic pseudarthrosis
15903740|NCT03620292|Drug|Bevacizumab-IRDye800CW|Intravenous administration of Bevacizumab-IRDye800CW prior to surgery for hilar cholangiocarcinoma
15903620|NCT03621423|Procedure|ultrasound guided injection|"Patient will be positioned lying on side with the hemiplegic side up. The shoulder will be placed in a flexion and external rotation/abduction position, as possible by the patient, to give the ultrasound probe access to the posterior axillary fold.
~As previously described in the literature, a line of best fit was calculated by bisection of hypothetical line connecting the inferior spine and the acromial tip, an 18-gauge, 10-cm needle will be inserted under direct ultrasound guidance and by a nerve stimulation . After placing the needle tip in the target point's 100 units of botulinum toxin will be injected."
15903621|NCT03621397|Device|brainHQ by Posit Science|This is an online cognitive training program. It consists of 29 online exercises that work out attention, brain speed, memory, people skills, navigation, and intelligence. The current study will focus on the following exercises: attention, brain speed (e.g., processing speed), executive function, and memory.
15903622|NCT03621371|Behavioral|Metacognitive therapy|Metacognitive therapy is a form av cognitive-behavioral therapy which aims to change cognitions about worry in patients with generalized anxiety disorder.
15903623|NCT03621371|Behavioral|Intolerance of uncertainty therapy|Intolerance of uncertainty therapy is a form av cognitive-behavioral therapy which aims to reduce cognitive and behavioral avoidance of uncertain situations or cognitions which lead to worry in patients with generalized anxiety disorder.
15903624|NCT03621358|Other|Control gummy with free flavour (without encapsulating)|12 g/day (3 gummies)
15903625|NCT03621358|Other|Experimental gummy with 50% free/50% encapsulated flavour|12 g/day (3 gummies)
15903626|NCT03621358|Other|Experimental gummy with 100% encapsulated flavour|12 g/day (3 gummies)
15903627|NCT03621345|Procedure|Erector spinae plane block|Ultrasound guided bilateral erector spinae plane block will be administered. An intravenous patient control analgesia device with morphine will be given to patients.
15903628|NCT03621345|Other|sham block|A sham block will be applied. Skin will be infiltrated with local anesthetics, and 2 mL subcutaneous saline injection will be applied.An intravenous patient control analgesia device with morphine will be given to patients.
15903629|NCT03621332|Other|Questionnaire|Online/paper questionnaires
15903630|NCT03621319|Device|Hybrid argon plasma ablation (HAPC)|-The assigned HAPC ablation will be performed at 8 to 12 week intervals until eradication of BE has been achieved or a total of 4 treatments have been performed
15903631|NCT03621319|Device|Radiofrequency ablation (RFA)|-The assigned RFA procedure will be performed at 8 to 12 week intervals until eradication of BE has been achieved or a total of 4 treatments have been performed
15903632|NCT03621306|Device|DXA and pQCT precision testing|The participants are only being observed; there is no intervention other than DXA and pQCT testing for the purposes of looking at instrument/technician precision..
15903633|NCT03621293|Drug|Modulation of Inspired Fraction of Oxygen (FiO2)|"In the two groups, if patient is not in the range of arterial oxygen pressure (PaO2), Inspired Fraction of Oxygen (FiO2) will be modified from 5 percent if difference between target is less than 5 mmHg and from 10 percent if difference from target is higher. A new arterial blood gases (ABG) will be performed 30 minutes later to check for the oxygen target range. When ABG are performed, pulsed oxymetry is compared with arterial saturation (SaO2) to adapt survey. Between each ABG, FiO2 is modified from 5 percent to 5 percent each five minutes until reaching good pulsed oxygen saturation (SpO2) target (that can be modified in function of the comparison of arterial oxygen saturation (SaO2 and SpO2 with ABG).
~This management of FiO2 will be done until extubation of the patient."
15903634|NCT03621280|Drug|Levoketoconazole|Levoketoconazole up to 1200 mg daily
15903635|NCT03621267|Other|Interactive Stepping Exercise|Interactive Stepping Exercise will perform on a thin mat, stepping pattern will display through a monitor screen, immediate auditory feedback will give for adjustment
15903636|NCT03621267|Other|Home exercise program|Home exercise program includes stretching exercise, general strengthening exercise on lower extremity muscles, posture control and balance exercise.
15903637|NCT03621254|Other|[LO-LONG]|Both interventions are different modalities of FES-evoked leg exercise, three-four times per week for 6-8 weeks (24 therapy sessions). The comparator intervention ([LO-LONG]) uses 20-40 min (patient state of fitness dependent) of continuous leg exercise of lower intensity.
15903638|NCT03621254|Other|[HI-SHORT|One intervention ([HI-SHORT]) uses a variety of leg exercise interval training of higher intensity for 10 x 2-min intervals.
15903639|NCT03621241|Diagnostic Test|Flow cytometry|Flow cytometry
15903640|NCT03621228|Device|MindfulGarden|MindfulGarden (MG) is an interactive digital technology that combines use of a smart television with sensors to intelligently generate content based on patient voice and gesture input, triggering a multi-layered visual 'garden' on-screen to arrest and de-escalate anxiety and aggression in treatment of hospitalized elderly diagnosed with hyperactive delirium.
15903641|NCT03621215|Dietary Supplement|Tart cherry juice|30 mL tart cherry juice concentrate (CherryActive, UK), diluted with water to 250 mL. This is consumed daily by participants, with breakfast, for 12 months.
15903642|NCT03621215|Other|Fruit-flavoured placebo drink|Consumed daily by participants, with breakfast, for 12 months.
15903643|NCT03621202|Device|Saranas Early Bird Bleed Monitoring System (EBBMS)|Participants will undergo their planned endovascular procedure with monitoring for internal bleeding using the Saranas EBBMS.
15903644|NCT03621189|Device|intermittent theta burst stimulation|stimulatory protocol
15903645|NCT03621176|Other|Home-based exercise|A booklet with detailed information will be provided, and the exercises will be previously reviewed with every patient by the researcher. Participants will be encouraged to perform at least 3 sessions per week and monitor their heart rate. They will be instructed that the exercises should be perceived as 'somewhat hard' from a rate of perceived exertion. Adaptations to increase the intensity of the exercises will be provided so that participants can progress in exercise intensity
15903646|NCT03621163|Procedure|Bleaching agent ( BOOST 40%)|Opalescence Boost 40% is a 40% hydrogen peroxide, medical power bleaching gel. The jet mix syringe ensures freshness for each application and precise dosing of the activator. One barrel contains a unique chemical activation with sodium fluoride and potassium nitrate, which have been demonstrated to reduce caries susceptibility, lower sensitivity, and improve enamel micro-hardness. The other barrel contains the concentrated hydrogen peroxide. When mixed, Opalescence Boost results in a 1.1% fluoride and 3% potassium nitrate concentration.
15903900|NCT03619005|Drug|Prasterone 6.5 mg (0.50%) Vaginal Insert|Daily administration of a 6.5 mg (0.50%) prasterone vaginal insert.
15903647|NCT03621163|Procedure|laminate veneers(lithium-silicate)|A lithium-silicate glass ceramic is newly introduced to the market. After crystallization, it demonstrates an ideal combination of strength, aesthetics and translucency that mirrors the vitality of natural teeth for fabrication of full anatomic anterior and posterior crowns. It differentiated from other ceramics by its high chipping resistance, due to their monolithic composition and average flexural strength of 385 MPa. Also Milling Block has good wear resistance due to the high content of ultra-fine nano-meter size crystalline structure. Lithium-silicates ceramic blocks are available in the commonly used VITA Classical and Chromascop Bleach shades.
15903648|NCT03621137|Other|No study-specific intervention|Treatment of atopic eczema with phototherapy or systemic immunomodulating therapy according to usual clinical practice
15903649|NCT03621124|Procedure|Resting Energy Expenditure|During each visit, the participant will be assessed in a resting state in a stable temperature controlled environment, and will undergo tests to find out how the body adjusts its metabolism to different temperatures.
15903650|NCT03621124|Other|Thermal Comfort Questionnaire|Patients will be given a questionnaire to assess their thermal response (whether they felt warmer or colder) during each study visit.
15903651|NCT03621111|Behavioral|Patient-counseling|After one month from the hospital discharge, the pharmacist will give to the patient general advices and suggestions regarding disease, therapy and drugs.
15903652|NCT03621111|Behavioral|Patient self-administered questionnaire|The pharmacist will submit the questionnaire to the patient for the evaluation of drug adherence, life style, feelings and approach to therapies, at 30 days, 3, 6, 9 and 12 months from the enrollment. This self-questionnaire of 13 questions contains the 8 multiple choice questions of the Morisky medication adherence scale (MMAS-8-Item, Italian version).
15903653|NCT03621111|Behavioral|Pills counts|At the time of the monthly drug re-supply at the community pharmacy, the patient will bring the boxes of the drugs taken in the previous month (empty or not), for the pill counts. The pharmacist will verify the correct assumption of the pharmacological therapies.
15903654|NCT03621085|Drug|Ketamine Hydrochloride|A total of 20 mg of Ketamine Hydrochloride will be administered intravenously
15903655|NCT03621085|Other|Placebo|Subjects will receive placebo
15903656|NCT03621072|Drug|Fluconazole 150mg Capsule Originator|150mg fluconazole capsule (originator) manufactured at Pfizer Fareva, Amboise, France
15903657|NCT03621072|Drug|Fluconazole 150mg Capsule Localized Originator|150mg Fluconazole capsule (localized originator) manufactured at Pfizer, Dalian, China
15903658|NCT03621059|Behavioral|habit reversal training (HRT)|"The intervention group received 4 sessions during 3months of behavior intervention and then, were reassessed at 3 and 6 months following treatment.
~Pyridoxine(50mg)"
15903659|NCT03621046|Drug|Zolpidem|Zolpidem is a non-benzodiazepine sedative/hypnotic agent usually prescribed for insomnia.
15903660|NCT03621046|Other|Placebo|Placebo
15903661|NCT03621033|Procedure|colonic transendoscopic enteral tubing|The procedure colonic transendoscopic enteral tubing is as follows:The TET tube was inserted into the ileocecal junction through the endoscopy channel at the first time of the cecal intubation after examination and evaluation of the whole colon. Then, the colonoscope was removed from the colon while the TET tube was maintained at the ileocecal junction. Then the endoscopy was inserted into the ileocecum again for affixing the TET tube to cecum with titanium clips.
15903662|NCT03621020|Diagnostic Test|T-TAS 01 PL Chip|Flow chamber microchip system specific for measuring primary hemostatic ability
15903663|NCT03621020|Diagnostic Test|PFA-100 Col/Epi and Col/ADP|System for measuring platelet dysfunction
15903664|NCT03620981|Drug|Brexpiprazole|Drug: 1 tablet /day Once daily for 10 weeks
15903665|NCT03620981|Drug|Placebo|Placebo: 1 tablet /day Once daily for 10 weeks
15903666|NCT03620968|Other|cognitive training|15 minutes day of brain training by an APP
15903667|NCT03620955|Other|Justified risk stratification based on MRD after three course chemo therapy|All patients are routinely divided into different risk groups according to the NCCN guild based on cytogenetic and molecular abnormality. Then all patients are treated with anthracycline combined with cytarabine regimens for two courses . The patients without obtaining CR will go on one cycle of salvage therapy and then be bridged to allo-HSCT. Those acquiring CR will be given one more course of HDAC as consolidation treatment and then be detested MRD with flow cytometry after that. The patients with MRD positive would be moved to a higher risk class.The stratified therapy should be considered according to the new risk stratification.
15903668|NCT03620942|Drug|Phenylephrine|"Phenylephrine will be administered with conditions as below:
~When systolic blood pressure is between 90-110% of baseline, 25mcg phenylephrine will be given either in infusion or bolus if heart rate ≥ 60 beats/min;
~When systolic blood pressure is less than 90% of baseline, 25 to 75mcg phenylephrine will be given either in infusion or bolus if heart rate ≥ 60 beats/min."
15903669|NCT03620942|Drug|Ephedrine|"Ephedrine will be administered with conditions as below:
~When systolic blood pressure is between 90-110% of baseline, 2mg ephedrine will be given either in infusion or bolus if heart rate < 60 beats/min;
~When systolic blood pressure is less than 90% of baseline, 2 to 6mg ephedrine will be given either in infusion or bolus if heart rate < 60 beats/min."
15903670|NCT03620942|Device|ADIVA System|"When systolic blood pressure (SBP) is 100-110% of baseline, 25mcg phenylephrine (infusion) is given if heart rate ≥ 60 beats/min, and 2mg ephedrine (infusion) is given if heart rate < 60 beats/min;
~When SBP is 90-100% of baseline, 25mcg phenylephrine (infusion or bolus) is given if heart rate ≥ 60 beats/min, and 2mg ephedrine (infusion or bolus) is given if heart rate < 60 beats/min;
~When SBP is 80-90% of baseline, 50mcg phenylephrine (infusion or bolus) is given if heart rate ≥ 60 beats/min, and 4mg ephedrine (infusion or bolus) is given if heart rate < 60 beats/min;
~When SBP < 80% of baseline, 75mcg phenylephrine (infusion or bolus) is given if heart rate ≥ 60 beats/min, and 6mg ephedrine (infusion or bolus) is given if heart rate < 60 beats/min."
15903671|NCT03620942|Device|DIVA System|"DIVA system works as below:
~When systolic blood pressure is between 90 to 100% of baseline, 25mcg phenylephrine (bolus) will be given if heart rate ≥ 60 beats/min, whereas 2mg ephedrine (bolus) will be given if heart rate < 60 beats/min;
~When systolic blood pressure is less than 90% of baseline, 50mcg phenylephrine (infusion or bolus) will be given if heart rate ≥ 60 beats/min, whereas 4mg ephedrine (infusion or bolus) will be given if heart rate < 60 beats/min."
15903741|NCT03620292|Device|near infrared (NIR) fluorescence imaging|Intraoperative NIR fluorescence imaging of hilar cholangiocarcinoma, lymph nodes, resection margins, resection specimens
15926247|NCT03448419|Drug|Empagliflozin|Film-coated tablet
15903672|NCT03620929|Drug|Estradiol Valerate|In all cases hormone therapy will be started from the day of operation, consisting of estradiol valerate at a dose of 4mg/d for 21 days, with the addition of dydrogesterone at a dose of 10 mg/d for the last 7 days of the estrogen therapy. After the withdrawal bleed, the hormone therapy will be repeated for another cycle. Second-look hysteroscopy will be carried out in the early proliferative phase, 4 weeks after the initial operation; a third-look hysteroscopy will be carried out 8 weeks after the initial operation. After assessment of the extent and severity of any reformed adhesion, hysteroscopic adhesiolysis will be carried out at the time of the second-look or third-look procedure, if adhesion had recurred.
15903673|NCT03620916|Procedure|Intravenous morphine|Single dose of intravenous morphine (0,15 mg/kg body mass) immediately after the operation, patient controlled analgesia with morphine (2 mg intravenously, a least 20 min interval) over first 24 postoperative hours and subcutaneous morphine (5 mg in case of numerical rating scale>4, at least 6 hour interval) over next two days
15903674|NCT03620916|Procedure|Intrathecal morphine|Single dose (0,4 mg) intrathecal morphine immediately before operation, patient-controlled analgesia with morphine (2 mg intravenously, a least 20 min interval) over first 24 postoperative hours and subcutaneous morphine (5 mg in case of numerical rating scale>4, at least 6 hour interval) over next two days in the postoperative period
15903675|NCT03620903|Drug|Ibrutinib / Bortezomib / Rituximab|Induction (Rituximab / Bortezomib / Ibrutinib), Maintenance I (Ibrutinib / Rituximab), Maintenance II (Ibrutinib)
15903676|NCT03620890|Drug|Neutral Protamine Hagedorn (NPH)|NPH will peak between 4-12 hours after injection with a duration of action around 14 hours
15903677|NCT03620890|Drug|Detemir insulin|Detemir is characterized by a gentle rise and fall with a longer duration of action (18-20 hours)
15903678|NCT03620877|Behavioral|Personalized intervention|Personalized intervention by a preventive nurse, relying on validated prevention models, in improving participation in the colonoscopic screening of siblings
15903679|NCT03620864|Other|Motor Control Exercises|Patients will receive 8 sessions of motor control exercise program of 30 min duration for 4 weeks, twice per week. Exercises will be demonstrated to the participants by an experienced physical therapist. On each session, the therapist will correct each subject personally. Participants will be asked for practicing the exercises at home once daily for 20 minutes over the 8-week intervention period. The motor control exercise program will consist of a progression from isolated contraction of the transversus abdominis and/or isolated contraction of the multifidi to combined contraction of both transversus abdominis in different positions from supine or prone to bridging or four-point kneeling.
15903680|NCT03620864|Other|Motor Control Exercise Plus Neurodynamic Intervention|Patients will receive 8 sessions of motor control exercise program of 30 min duration for 4 weeks, twice per week. Exercises will be demonstrated to the participants by an experienced physical therapist. On each session, the therapist will correct each subject personally. Participants will be asked for practicing the exercises at home once daily for 20 minutes over the 8-week intervention period. The motor control exercise program will consist of a progression from isolated contraction of the transversus abdominis and/or isolated contraction of the multifidi to combined contraction of both transversus abdominis in different positions from supine or prone to bridging or four-point kneeling. In addition, participants allocated to the neurodynamic group will also receive a nerve neurodynamic slider intervention targeting the main trunk of the sciatic nerve of the affected side during al treatment sessions (n=8).
15903681|NCT03620851|Other|effect of age|effect of age on the efficiency of enhanced recovery program
15903682|NCT03620838|Drug|oral contraceptive pill, oral progesterone|ovarian endometrioma cyst excision
15903683|NCT03620825|Other|Dehydration by sauna exposure|Participants repeatedly undergo sauna exposures until they loose 3% of their body weight.
15903684|NCT03620825|Drug|Indomethacin|Participants take indomethacin in tablet form the evening before and the morning of the visit to induce intestinal permeability
15903685|NCT03620812|Dietary Supplement|rapeseed or soy protein or no protein|25g rapeseed protein in comparison to 25g soy protein or no protein - dosage of 25 g per day
15903686|NCT03620799|Procedure|Manual therapy|A manual intervention technique is employed to the intervention group based on a roller treatment.
15903687|NCT03620786|Device|Sonablate HIFU device|In this study, we will be using the Sonablate 450 HIFU System. The Sonablate HIFU device was approved by the U.S. FDA for prostate tissue ablation in October, 2015. HIFU is an example of focal therapy, where the intervention involves targeting diseased areas of prostate tissue, while preserving healthy prostate tissue and minimizing damage to surrounding structures.
15903688|NCT03620773|Drug|Aminohippurate Sodium Inj 20%|Diagnostic aid/agent used to measure effective renal plasma flow (ERPF)
15903689|NCT03620773|Drug|Iohexol Inj 300 mg/mL|Diagnostic aid/agent used to measure glomerular filtration rate (GFR)
15903690|NCT03620773|Procedure|Vertical Sleeve Gastrectomy|Participants will undergo vertical sleeve gastrectomy surgery, a laparoscopic bariatric surgery procedure designed for weight loss in obese patients
15903691|NCT03620773|Procedure|Renal Biopsy|Minimally invasive outpatient procedure in interventional radiology to obtain renal tissue cores.
15903692|NCT03620760|Drug|Ticagrelor 90 mg|Ticagrelor (AZD6140) 90 mg twice daily dose
15903693|NCT03620760|Drug|Ticagrelor 45 mg|Ticagrelor (AZD6140) 45 mg twice daily dose
15903694|NCT03620760|Drug|Aspirin|Aspirin 100 mg once daily dose
15903695|NCT03620747|Drug|Dupilumab SAR231893 (REGN668)|"Pharmaceutical form: prefilled syringes
~Route of administration: subcutaneous"
15903696|NCT03620721|Behavioral|mindfulness|8-week mindfulness based group intervention
15903697|NCT03620708|Behavioral|Motivational Interviewing|Participants are provided with a 35 minute counseling session designed to increase motivation to quit smoking and then provided with a written referral for tobacco dependence treatment.
15903698|NCT03620708|Drug|Nicotine Replacement Therapy Sampling|Participants are provided with a two-week sample of over-the-counter nicotine replacement therapy (i.e., nicotine lozenge and nicotine patch) and then provided with a written referral for tobacco dependence treatment.
15903699|NCT03620708|Behavioral|Referral Only|Participants are provided with a written referral for tobacco dependence treatment.
15903742|NCT03620279|Behavioral|Magic camp intervention|Hand-arm bimanual motor skills training
15903960|NCT03618511|Behavioral|Financial Incentive|Financial Incentive: Participants will receive monthly financial incentives each time they refill the ART medication on time for six months
15903700|NCT03620682|Behavioral|Coaching sessions|Participants receive three 30-minute phone sessions with a doctorate-level therapist over the course of one month. These sessions are skills-based and focus on improving participants' problem solving through cognitive-behavioral techniques. Participants are allowed to text the therapist between sessions for information and support.
15903701|NCT03620682|Behavioral|Mobile applications|Participants will have access to 3 mobile apps for the duration of the study, and after it ends. One app will push participants a daily, self-reflective survey to complete, and a daily motivational or instructional tip to rate. Other apps will provide education and exercises on various aspects of mental health and wellness, such as sleep and relaxation.
15903702|NCT03620669|Drug|Durvalumab|Durvalumab 1500mg q4W until progression or unacceptable toxicity
15903703|NCT03620656|Diagnostic Test|FibriCheck|Photoplethysmography-based smartphone or smartwatch sensor to assess cardiac rhythm
15903704|NCT03620643|Drug|Crizotinib Oral Capsule [Xalkori]|Crizotinib 250 mg Crizotinib 200mg
15903705|NCT03620643|Drug|Fulvestrant 50 MG/ML Prefilled Syringe [Faslodex or generic]|Fulvestrant (Faslodex or generic) is supplied as two 5-mL clear neutral glass (Type 1) barrels, each containing 250mg/5mL of fulvestrant solution for intramuscular injection and fitted with a tamper evident closure.
15903706|NCT03620630|Device|myCOPD|myCOPD is a multi faceted web based application designed to support people with COPD in the Long term management of their COPD.
15903707|NCT03620617|Dietary Supplement|Raspberry supplement|During the 8-week protocol, participants will be invited either to consume 280g of frozen raspberries daily (morning and evening). The daily dose is equivalent to 2 cups of raspberries.
15903708|NCT03620604|Device|Stress urinary incontinence surgery|All patients were treated according to the Urology protocols of our unit. They were patients with stress urinary incontinence refractory to pelvic floor exercises so they underwent surgery
15903709|NCT03620591|Drug|Lidocaine|Intraoperative administration of lidocaine
15903710|NCT03620591|Drug|Placebo|Intraoperative administration of normal saline
15903711|NCT03620578|Drug|DA-EPOCH-R followed by Nivolumab|5 induction cycles of DA-EPOCH-R protocol, for patient with Deauville imaging response criteria proven complete metabolic response followed with one year Nivolumab consolidation therapy
15903712|NCT03620552|Drug|18F-S16|A single dose of nearly 370MBq 18F-S16 were intravenously injected into the subjects immediately before the PET/CT scans
15903713|NCT03620539|Other|Lifestyle intervention|Sauna bathing
15903714|NCT03620526|Drug|Iloprost|Investigators performed cardiac catheterization as previously described. Hemodynamic values were recorded for the ﬁrst exercise phase (before any drug administration) and after return to steady state baseline hemodynamic values, and the second exercise phase (after drug administration). Subjects were randomized 1:1 to inhalation of placebo (normal saline solution) or iloprost (50 mg/kg/min) (Bayer Pharmaceuticals, Scottsdale, Ari-zona) for 5 min. The iloprost/placebo inhalation were identical in appearance and prepared by the research pharmacy, ensuring double-blinding of inhalation content. After finishing inhalation process for 10 min, hemodynamic measurements were repeated at rest, followed by repeat supine exercise at a 20-W workload for 6 min, identical to the study's ﬁrst phase.
15903715|NCT03620526|Drug|Placebo|Investigators performed cardiac catheterization as previously described. Hemodynamic values were recorded for the ﬁrst exercise phase (before any drug administration) and after return to steady state baseline hemodynamic values, and the second exercise phase (after drug administration). Subjects were randomized 1:1 to inhalation of placebo (normal saline solution) or iloprost (50 mg/kg/min) (Bayer Pharmaceuticals, Scottsdale, Ari-zona) for 5 min. The iloprost/placebo inhalation were identical in appearance and prepared by the research pharmacy, ensuring double-blinding of inhalation content. After finishing inhalation process for 10 min, hemodynamic measurements were repeated at rest, followed by repeat supine exercise at a 20-W workload for 6 min, identical to the study's ﬁrst phase.
15903716|NCT03620513|Drug|Decongestant (oxymetazoline 0.05%)|As described in arm/group
15903717|NCT03620513|Drug|Anesthesia (Lidocaine 15%)|As described in arm/group
15903718|NCT03620513|Drug|Decongestants and Anesthesia (oxymetazoline and lidocaine)|As described in arm/group
15903719|NCT03620513|Drug|Normal saline|Spray of normal saline as premedication
15903720|NCT03620500|Behavioral|Gross motor and developmental balance testing|Balance (Pediatric Balance Scale) and gross motor skill development (Peabody Developmental Motor Scales, 2nd edition). Quality of life will be assessed using the Life-H (Assessment of Life Habits).
15903721|NCT03620474|Drug|PRI-724|twice a week for 4 hours continuous intravenous administration of PRI-724
15903722|NCT03620461|Drug|Gemcitabine - nabpaclitaxel|efficacy and safety
15903723|NCT03620448|Device|bCPAP Arm|bCPAP (Rice 360◦c low cost bCPAP device)
15903724|NCT03620448|Other|Oxygen Arm|Oxygen therapy from oxygen cylinders
15903725|NCT03620435|Drug|Atezolizumab|Atezolizumab (1200mg iv, every 3 weeks) administered concurrently with TMT and adjuvant for up to one year
15903726|NCT03620422|Other|Mannitol|Mannitol-Induced Cough Challenge
15903727|NCT03620422|Drug|Salbutamol 5mg/mL|Nebulized salbutamol given prior to Mannitol-Induced Cough Challenge
15903728|NCT03620422|Other|Sodium Chloride 0.9% Inhl 3Ml|Nebulized 0.9% saline given prior to Mannitol-Induced Cough Challenge
15903729|NCT03620396|Procedure|Scaling and root planing|After the serum collection is done from the patient for the assessment of trefoil factor 3, Non surgical periodontal therapy is carried out.
15903730|NCT03620383|Procedure|Topical Heat|Warm heat pack applied topically in participant hand.
15903731|NCT03620370|Drug|Normobaric oxygen therapy|In this study, it is simple to administer via oxygen storage facemask at flow rates of 10 L/min for 4 hours. This therapy start should in Pre-hospital or emergency room as early as possible after diagnosed ischemic stroke and uninterrupted during other treatments including mechanical thrombolytic therapy and standard clinical treatment.
15903732|NCT03620357|Device|CGM|CGM Group: Dexcom G6 CGM
15903733|NCT03620357|Device|SMBG|SMBG Group: Blood Glucose Meter
15903734|NCT03620344|Other|ADH-Me Book and ADHD Informational Brochure|"Understanding ADHD information brochure published by American Academy of Pediatrics and a children's book about ADHD condition"
15903735|NCT03620344|Other|ADHD Informational Brochure Only|"Understanding ADHD information brochure published by American Academy of Pediatrics"
15903736|NCT03620331|Procedure|Surgery with a previous non-surgical approach|Non-surgical phase done prior to the surgical treatment of peri-implantitis
15903743|NCT03620266|Dietary Supplement|Bilberry|The dietary intervention will be initiated within five days post PCI and will be continued for three months. After randomization, participants will be given bilberry shakes (active), liquid oat shakes (active), a combination shake with bilberry and oats, or reference shakes (placebo product containing no active bilberry or active oats but with similar taste and texture as both oat and bilberry), for intake two times a day (t.i.d). The formula for the shakes to be used in the intervention will be finalized during the initial project period.
15903744|NCT03620266|Dietary Supplement|Placebo|The dietary intervention will be initiated within five days post PCI and will be continued for three months. After randomization, participants will be given bilberry shakes (active), liquid oat shakes (active), a combination shake with bilberry and oats, or reference shakes (placebo product containing no active bilberry or active oats but with similar taste and texture), for intake two times a day (t.i.d). The formula for the shakes to be used in the intervention will be finalized during the initial project period.
15903745|NCT03620266|Dietary Supplement|Bioprocessed oat bran|The dietary intervention will be initiated within five days post PCI and will be continued for three months. After randomization, participants will be given bilberry shakes (active), liquid oat shakes (active), a combination shake with bilberry and oats, or reference shakes (placebo product containing no active bilberry or active oats but with similar taste and texture), for intake two times a day (t.i.d). The formula for the shakes to be used in the intervention will be finalized during the initial project period.
15903746|NCT03620266|Dietary Supplement|Combination bilberry/oats|The dietary intervention will be initiated within five days post PCI and will be continued for three months. After randomization, participants will be given bilberry shakes (active), liquid oat shakes (active), a combination shake with bilberry and oats, or reference shakes (placebo product containing no active bilberry or active oats but with similar taste and texture), for intake two times a day (t.i.d). The formula for the shakes to be used in the intervention will be finalized during the initial project period.
15903747|NCT03620253|Drug|Modafinil|Participants randomized to the modafinil group will receive 100 mg of modafinil capsules for 1 week, followed by 200 mg for 7 weeks (as long as the drug is well tolerated), which they will take daily in the morning. During this time, participants will complete questionnaires and neurocognitive tests, and report adverse events at study visits.
15903748|NCT03620253|Drug|Placebo|Participants randomized to the placebo group will receive 100 mg placebo capsules for 1 week, followed by 200 mg for 7 weeks, which they will take daily in the morning. During this time, participants will complete questionnaires and neurocognitive tests, and report adverse events at study visits.
15903749|NCT03620240|Behavioral|Sleep Education|Assessing the effectiveness of a Sleep Education Program in improving sleep behaviors in secondary school students.
15903750|NCT03620227|Other|Exercise|40 minutes of aerobic exercise on a treadmill, with a fixed speed of 5.5 km/h and intensity imposed by treadmill inclination until it reaches the frequency zone between 60% and 75% of the reserve heart rate.
15903751|NCT03620227|Dietary Supplement|Beetroot juice|Ingestion of 350ml of concentrated beetroot juice (400mg of nitrate) 100 minutes before an exercise session.
15903752|NCT03620227|Dietary Supplement|Placebo|Ingestion of 350ml of placebo (0mg of nitrate, with the same color, taste and smell) 100 minutes before an exercise session.
15903753|NCT03620201|Drug|Bintrafusp Alfa|Given IV
15903754|NCT03620188|Other|Standard of care|Standard of care in PsA is outline in treatment guidelines as adjustment of therapy every 3 months until goals of treatment are being met. Goals of treatment are defined as remission or low disease activity.
15903755|NCT03620175|Drug|TolaSure Topical Gel|TolaSure topical gel is applied to skin punch biopsies daily over the course of 2 weeks.
15903756|NCT03620162|Biological|Prevnar 13™|Prevnar 13™ contains the pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each) and 6B (4.4 mcg) in each 0.5 mL dose given via IM injection.
15903757|NCT03620162|Biological|V114|V114 contains the pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose given via IM injection.
15903758|NCT03620162|Biological|RotaTeq™|RotaTeq™ live, pentavalent Rotavirus vaccine given as background treatment via oral solution.
15903759|NCT03620162|Biological|Pentacel™|Pentacel™ Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine, given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
15903760|NCT03620162|Biological|RECOMBIVAX HB™|RECOMBIVAX HB™ Hepatitis B Vaccine (Recombinant), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
15903761|NCT03620162|Biological|HIBERIX™|HIBERIX™ Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate), given as background treatment via IM injection in the opposite limb to V114 and Prevnar 13™ administration.
15903762|NCT03620162|Biological|M-M-R™ II|M-M-R™ II (Measles, Mumps, and Rubella Virus Vaccine Live), given as background treatment via subcutaneous (SC) injection in the opposite limb to V114 and Prevnar 13™ administration.
15903763|NCT03620162|Biological|VARIVAX™|VARIVAX™ Varicella Virus Vaccine Live, given as background treatment via SC injection in the opposite limb to V114 and Prevnar 13™ administration.
15903764|NCT03620149|Drug|Denosumab 120 MG/1.7 ML Subcutaneous Solution [XGEVA]|Denosumab 120 mg, SC, on day 1 of every 12-week cycle
15903765|NCT03620136|Drug|locoregional analgesia by a block on the adductor channel|"The block at the adductor channel will be realized under echo guidance, before the spinal anesthesia, by puncture at the upper 1/3 of the thigh. It will be used echogenic needle adapted to the morphotype of each patient, of varying length from 50mm to 100mm. A single injection of 20mL of ROPIVACAINE 2mg / ml, the efficacy of which should be checked before spinal anesthesia is performed by a cold test.
~Knee analgesia will be supplemented by per-operative infiltration of 50mL of ROPIVACAINE 2mg / ml at the posterior capsule, once the surfaces joints prepared to accommodate the prosthesis and by two placebo infiltrations of 50mL each of physiological saline in the medial and lateral ligaments and in the edges of the incision."
15903791|NCT03619928|Device|Massotherapy|A 20-minute massage will be applied to the non-dominant upper limb exercised by a therapist for the massage condition. The massage will consist of: 1) surface slip; 2) deep slip; 3) kneading; 4) friction with the thumbs; 5) friction with four fingers; 6) percussions with open and alternating hands; 7) percussions with open and simultaneous hands; 8) tapping; and 9) surface slip.
15903766|NCT03620136|Drug|locoregional analgesia by periarticular local infiltrations|"A placebo injection to the adductor channel of 20 mL of physiological serum will be performed in the pre-induction room before surgery, according to the same procedures as the patients of the ACB group.
~During the surgical procedure, patients in the ILA group will receive a total dose of 300mg of ROPIVACAINE 2mg / ml in the form of 3 periarticular injections. The first injection of 50mL of ROPIVACAINE 2mg / ml will be made once the articular surfaces are prepared to receive the prosthesis, at the level of the posterior capsule. The second injection of 50mL of ROPIVACAINE 2mg / ml will be performed once the total knee prosthesis is installed, in the medial and lateral ligaments. Finally, the last injection will also include 50mL of ROPIVACAINE 2mg / ml and will be made in the edges of the incision at the time of closure."
15903767|NCT03620123|Drug|Nivolumab and Ipilimumab|Nivolumab 3 mg/kg of body weight intravenous infusion every two weeks and ipilimumab 1 mg/kg of body weight intravenous infusion every six weeks
15903768|NCT03620123|Drug|Docetaxel|docetaxel 75 mg/m² intravenous infusion every three weeks
15903769|NCT03620097|Dietary Supplement|EuPoly-3 DHA Infant|Children will be selected in the first 18 months of the study, and patients with ASD will be included in the trial consecutively, and will be divided into two parallel groups according to the randomization generated by the SIGESMU® computer program with random assignment 1: 1: 30 subjects will receive 800mg of DHA per day and another 30 children, a placebo with similar lipid characteristics except that it will not have DHA content, and for a period of 6 months, double blind. After 6 months, a clinical evaluation and the same baseline analytical study will be carried out again.
15903770|NCT03620097|Other|Placebo|Children will be selected in the first 18 months of the study, and patients with ASD will be included in the trial consecutively, and will be divided into two parallel groups according to the randomization generated by the SIGESMU® computer program with random assignment 1: 1: 30 subjects will receive 800mg of DHA per day and another 30 children, a placebo with similar lipid characteristics except that it will not have DHA content, and for a period of 6 months, double blind. After 6 months, a clinical evaluation and the same baseline analytical study will be carried out again.
15903771|NCT03620084|Device|Expiratory Muscle Strength Training (EMST)|The target home practice frequency on the EMST-150 is: 5 repetitions of forceful expiration each time, 5 times daily, 5 days a week for 8 weeks, following the training protocol used by Hutcheson et al. (2017).
15903772|NCT03620071|Other|GoalKeeper|Mobile-health communication tool for parents of children with medical complexity
15903773|NCT03620071|Other|Standard Care|Standard Clinical Care
15903774|NCT03620058|Biological|CART22-65s cells|Autologous T cells transduced with a lentiviral vector to express anti-CD22 scFv TCRz:41BB
15903775|NCT03620058|Biological|huCART19 Cells|Autologous T cells transduced with lentiviral vector to express anti-CD19 scFv TCRζ:4-1BB
15903776|NCT03620045|Behavioral|Acute moderate physical activity|For 20 minutes, participants will walk on a treadmill at a moderate intensity based on a combination of evidence-based and pre-determined parameters, including ratings of perceived exertion and heart rate
15903777|NCT03620032|Drug|Nimotuzumab|humanized therapeutic monoclonal antibody against epidermal growth factor receptor (EGFR)
15903778|NCT03620032|Drug|Vinorelbine|Chemotherapy
15903779|NCT03620032|Other|Radiotherapy|RADIOTHERAPY SCHEDULE IS DESCRIBED FOR BOTH GROUPS IN THE PERAGRAPH TITLET ARMS
15903780|NCT03620019|Drug|Denosumab|A dose of 120 mg will be administered as a subcutaneous (s.c.) injection every 4 weeks in the upper arm, upper thigh, or abdomen. Another loading dose of 120 mg s.c. denosumab will be administered on day 8. On days when denosumab is administered on the same day as pembrolizumab, the s.c. injection should be given after the infusion of pembrolizumab is completed.
15903781|NCT03620019|Drug|Pembrolizumab|Pembrolizumab will be administered as standard of care following the institutional guidelines.The recommended dose of pembrolizumab is 200 mg administered as an IV infusion over approximately 30 minutes (range: 25 - 40 minutes) every 3 weeks until disease progression or unacceptable toxicity.
15903782|NCT03620019|Drug|Nivolumab|Nivolumab will be given every four weeks at a dose of 480 mg to be administered as an IV infusion per institutional guidelines.
15903783|NCT03619993|Device|On-body injector|Medical device for subcutaneous injection of a supportive medicine (Pegfilgrastim) automatically after 27 hours after application of device.
15903784|NCT03619993|Device|Pre-filled syringe|For subcutaneous injection of a supportive medicine (Pegfilgrastim).
15903785|NCT03619980|Other|No intervention|Retrospective study to evaluate time to event and healthcare resource utilisation of prostate cancer patients throughout the different disease stages, until progression or death.
15903786|NCT03619967|Device|Multispectral imager|"Device: Bio-inspired multispectral imager
~-Manufactured at University of Illinois at Urbana Champaign"
15903787|NCT03619954|Biological|NK cells infusion|"Pretreatment：patients enrolled in this study will receive 20 mg/kg of cyclophosphamide for solid tumor or 20-60 mg/kg of cyclophosphamide for hematological tumor once daily for 3 times. NK cells infusion is allowed within 2-14 days after treatment.
~NK cells infusion：30-60 minutes before infusion，ant-allergic agents are applied (promethazine 25mg,i.m. ; Cimetidine 0.4g i.v. ; diphenhydramine 50mg po.). NK cells are intravenously infused into patients with 15-30 minutes every other day for one to three times. The number of every infused NK cells is 1-3×10^7/kg, counted as the number of CD56+ cells. Patients with severe pleural or ascites can also receive pleural or abdominal cavity perfusion simultaneously. The total number of infused NK cells is no more than 5×10^9 cells. 4 hours after NK cells infusion，IL-2 is applied every other day for six times"
15903788|NCT03619941|Dietary Supplement|Montmorency Tart Cherry Juice|"100% natural, tart Montmorency cherry concentrate (30mL) diluted with 100mL water.
~Concentrate contains no sweeteners, preservatives, flavourings or added sugar."
15903789|NCT03619941|Dietary Supplement|Placebo|Placebo drink attempted to match for total energy content, macronutrient content, appearance and taste of Montmorency tart cherry juice.
15903790|NCT03619928|Device|Dry needling|20 minutes through a sterile, disposable Dong Bang® needle size of 0.25X30 mm. At the moment of insertion of the needle, the therapist will perform a muscular shortening around the application site, in a pincer movement performed by the index and thumb fingers, in order to isolate the muscle fibers of the biceps brachii. Five needles will be applied to the short head brachii biceps in five points: origin, insertion, center of the muscular womb (60% of the distance from the medial acromion to the cubital fossa in the elbow line) and two points equidistant from the center 2 cm.
15926248|NCT03448419|Drug|Placebo|Film-coated tablet
15903792|NCT03619915|Diagnostic Test|Spirometry|The test will follow the norms of the American Thoracic Society and reference values relative to the Brazilian population. The tests will be performed by physical therapists using the One Flow FVC® portable spirometer (Clement Clarke, England) and met the criteria for acceptance and reproduction of manoeuvres
15903793|NCT03619915|Other|Functional Independence Measure|Will be used to evaluate the functional independence of patients containing eighteen items encompassing six dimensions. Each item can receive scores of one to seven, where one corresponds to total dependency and seven to full independence. Each dimension is analysed by the sum of the items that compose it and the total score is given by the sum of each dimension, being able to vary from 18: complete dependence; 19 to 60: greater dependence (assistance of up to 50% of tasks); 61 to 103: less dependency (assistance of up to 25% of tasks); and 104 to 126: independent.
15903794|NCT03619902|Drug|ANB019|Humanized Monoclonal Antibody
15903795|NCT03619889|Other|Manual pressure release technique on trigger points.|A specific pressure is applied on trigger points of masticatory and neck muscles between pain pressure threshold and pain tolerance (7-8 visual analog scale).
15903796|NCT03619889|Other|Sham|A simulated pressure release technique is applied around masticatory and neck muscles.
15903797|NCT03619876|Drug|Abatacept|125 MG/ML subcutaneous injections
15903798|NCT03619876|Drug|Adalimumab|40 Mg/0.8 mL Subcutaneous Kit
15903799|NCT03619850|Drug|Ferumoxytol|Each 20 mL single-use vial contains 17 mL of ferumoxytol that consists of iron at a concentration of 30 mg Fe/mL, coated with polyglucose sorbitol carboxymethylether and formulated with mannitol, at a concentration of 44 mg/mL, in a black to reddish brown sterile, aqueous, colloidal, isotonic solution.
15903800|NCT03619850|Drug|Iron sucrose|Each mL contains 20 mg of elemental iron as iron sucrose in water for injection. The 5 mL single-use vial contains 100 mg of iron per 5 mL. The drug product contains approximately 30% sucrose (300 mg/mL).
15903801|NCT03619837|Drug|Sofosbuvir/Velpatasvir|Sofosbuvir/Velpatasvir starting early post-transplant for total of 12 weeks.
15903802|NCT03619837|Drug|Sofosbuvir/Velpatasvir/Voxilaprevir|"Only for patients who fail initial treatment with Sofosbuvir/Velpatasvir.
~Dosage: 400mg/100mg/100mg daily for 12 weeks."
15903803|NCT03619824|Drug|Sintilimab|Sintilimab 200mg ivdrip, every 3 weeks for 6 cycles
15903804|NCT03619824|Drug|Gemcitabine|Gemcitabine 1g/m2, d1 & 8 of every cycle, every 3 weeks for 3 cycles before radiation.
15903805|NCT03619824|Drug|Cisplatin|Induction cisplatin 80mg/m2, every 3 weeks for 3 cycles before radiation Concurrent cisplatin 100mg/m2, every 3 weeks for 2 cycles during radiation
15903806|NCT03619824|Radiation|intensity-modulated radiotherapy|Definitive IMRT of 66-70Gy will be given in six to seven weeks.
15903807|NCT03619811|Diagnostic Test|Reflux Band® Upper Esophageal Sphincter (UES) Assist Device|UES augmentation via the UES assist device is effective in true Reflux associated laryngeal symptoms. In our first pilot trial with the UES assist device, patients had significant symptom reduction following 2 weeks of UES assist device use. Based on our preliminary work, we theorize that the UES assist device is effective in Reflux associated laryngeal symptoms.
15903808|NCT03619798|Device|HemoTypeSC|Point-of-Care Rapid Test for Detection of Sickle Cell Disease-Relevant Hemoglobin Phenotypes in Whole Blood
15903809|NCT03619785|Drug|Bupivacaine|Patient will be positioned supine or in the lateral decubitus position on the side contralateral to the fracture(s). A 3.5 in 20-gauge needle, extension tubing, and a 30 mL syringe loaded with 0.25% bupivacaine and 3 mL of 1% lidocaine loaded in a 5 mL syringe with a 27-gauge needle will be prepared. The ribs, teres minor, latissimus dorsi, and serratus anterior will be identified with bedside US and the site of entry marked along the lateral aspect of the 4th-5th rib. The skin will be sterilized and lidocaine placed at the site of entry. The needle will be introduced at a steep angle and advanced in-plane, under US-guidance, to the plane superficial to the serratus anterior muscle. A test dose of normal saline will confirm proper needle tip placement with opening of the intramuscular layer. Injection with aliquots of 3-5 mL after negative aspiration will continue until 30mL of 0.25% bupivacaine are administered.
15903810|NCT03619785|Drug|Fentanyl, morphine, hydromorphone, hydrocodone, acetaminophen, ketorolac, gabapentin, ketamine, ibuprofen|Oral or IV pain medication as needed.
15903811|NCT03619772|Other|Bilateral|Participants will control game using EMG from both upper limbs.
15903812|NCT03619772|Other|Unilateral|Participants will control game using EMG from the more impaired upper limb.
15903813|NCT03619759|Drug|Sugammadex|Sugammadex injection as a reverse agent of neuromuscular blocking
15903814|NCT03619746|Behavioral|POCUS Educational Intervention|Midway through the study, all Pediatric Emergency Attendings and Fellows at Jacobi Medical Center will receive an educational session that describes how to properly perform a soft tissue examination using point-of-care ultrasound to differentiate between cellulitis and local allergic reaction.
15903815|NCT03619733|Other|no intervention|this is an observational study. no intervention is planned
15903816|NCT03619720|Other|Records|Respiratory records, Vocal records Video records Questionnaires
15903817|NCT03619707|Drug|Progesterone|Patients will be randomly assigned during the treatment follow up, at the time of addition of progesterone to the regimen, following computerized random number generator in procedure, to one of the study groups. Patients will be aware of the allocated arm since the treatment drugs have different route of administration. Group I will receive the oral dydrogesterone, while group II will receive the vaginal microprogesterone.
15903818|NCT03619694|Device|MRI Spectroscopy|Patient with brain SOL underwent MRI Spectroscopy to be compared with later pathology
15903819|NCT03619681|Drug|KN026|Patient will be intravenously administrated with one dose of KN026. dosing interval may be adjusted during the study based on emerging data from this trial and/or from other trial.
15903820|NCT03619655|Procedure|SPECT CT|MDP (99mTc-MDP) administration, about 180 min post-injection: whole body scan followed by a SPECT CT of regions designated by a board certified Nuclear Medicine physician after review of the whole body scan.
15903821|NCT03619655|Drug|18F-DCFPyL PET/CT|A bolus of ~9 mCi (333 MBq) of 18F-DCFPyL will be injected by slow IV push.
15903822|NCT03619655|Drug|18F-NaF PET/CT|A dose of 5 mCi 18F-NaF is injected through the IV and followed by at least 10 ml of saline to flush the IV line of the remaining dose. At the 1 hour post injection time, total Whole Body Images take approximately 40 - 60 minutes depending on the height of the patient.
15903823|NCT03619655|Procedure|WB-MRI|Whole body MRI exam (total examination time < 50 minutes)
15903824|NCT03619642|Other|Robotic assessment of finger proprioception|The assessment will be performed using a robotic device specifically designed for the assessment of finger proprioception at the metacarpophalangeal (MCP) joint .
15903825|NCT03619629|Other|Kinesio-tape|"Kinesiotape will be applied both ankles as Correction technique."
15903826|NCT03619629|Other|Mulligan's mobilization with movement|'Posterolateral glide mobilization with movement' will be applied 10 times to both ankles.
15903827|NCT03619629|Other|Sham Kinesio-taping|Sham Kinesio-taping technique will be applied both ankles.
15903828|NCT03619629|Other|Sham Mulligan's mobilization with movement|Sham Mulligan's mobilization with movement technique will be applied both ankles.
15903829|NCT03619616|Drug|ZSP1603 7.5 mg|ZSP1603 capsule administered orally once daily under fasted condition.
15903830|NCT03619616|Drug|ZSP1603 12.5 mg|ZSP1603 capsule administered orally once daily in the fasting state.
15903831|NCT03619616|Drug|Placebo 12.5mg|Participants will receive placebo matching to ZSP1603 orally once daily under fasted condition.
15903832|NCT03619616|Drug|ZSP1603 25 mg|ZSP1603 capsule administered orally once daily under fasted condition.
15903833|NCT03619616|Drug|Placebo 25mg|Participants will receive placebo matching to ZSP1603 orally once daily in the fasting state.
15903834|NCT03619616|Drug|ZSP1603 50 mg|ZSP1603 capsule administered orally once daily under fasted state.
15903835|NCT03619616|Drug|Placebo 50mg|Participants will receive placebo matching to ZSP1603 orally once daily in the fasting state.
15903836|NCT03619590|Other|Data Collection|When the pregnancy is reported prospectively, the Registry will collect registration data from the reporter through telephone interview or a short registration form. In the month of the estimated date of delivery, follow-up will be sought by telephone contact or a form mailed to the health professional. Information about maternal events throughout the pregnancy, pregnancy outcome, and neonatal health is requested. Additional follow-up is not sought from subsequent health care providers.
15903837|NCT03619577|Behavioral|Sequential training|For cognitive training, the BrainHQ program, self-made teaching aids and board games will be used to train different cognitive functions of the participants. For physical exercise, we design the programs that involve balance or strength training components in the aerobic exercises. All participants will first perform 60 minutes of physical exercise followed by 60 minutes of cognitive training.
15903840|NCT03619538|Drug|Nefopam|The nefopam group received 120 mg nefopam (Acupan, Pharmbio, France) by continuous iv infusion over the study period (48h)
15903841|NCT03619538|Other|saline solution|The Control group received 120 mg placebo infusion (saline solution) by continuous iv infusion over the study period (48h).
15903842|NCT03619525|Procedure|lung recruitment|During bypass, patients in this group will receive a lung protective design in the form of continuous positive airway pressure (CPAP) by closing APL valve at pressure of 5 Cm H2o combined with intermittent recruitment by sustained manual lung inflation at a pressure of 35 cmH2O for 30 seconds every (30-40) minute
15903843|NCT03619512|Genetic|Whole exome sequencing.|Retrospective biological exploration of the samples, including tumoral DNA exploration.
15903844|NCT03619512|Genetic|RNA sequencing|Characterization of tumor transcriptomic profile.
15903845|NCT03619512|Other|Mass spectrometry|Characterization of tumor proteomic profiles.
15903846|NCT03619499|Device|non invasive ventilation|patients who will fulfill the criteria of severe bronchiolitis will be connected to non invasive ventilation including continuous positive airway pressure via nasal prongs or nasal mask. Mode of ventilation, inspired oxygen levels, oxygen saturation, respiratory rate, and blood gas values from arterial samples prior to and after 2 and 4 hrs of ventilation or nearest time, will be documented.
15903847|NCT03619486|Device|Low energy shock wave|Probe be transcutaneous applied to the suprapubic bladder region with 2000 shocks, frequency of 3 pulses per second and maximum total energy flow density 0.25 millijoule/mm2 once a week for 4 weeks
15903848|NCT03619486|Device|Placebo|Probe be transcutaneous applied to the suprapubic bladder region with 2000 shocks, frequency of 3 pulses per second but no energy once a week for 4 weeks
15903849|NCT03619473|Behavioral|Standard motorcycle child safety helmet|"Educational session followed by demonstration on
~proper helmet wearing
~how to differentiate non-standard and standard helmets
~how to keep motorcycle safe using ABCD concept
~importance of wearing bright clothes
~police summon for not wearing helmets
~live demo on poor performance of non-standard helmet
~giving away standard motorcycle child safety helmets
~oath taking by parents and children
~distribution and placement of VEM on parents' motorcycles"
15903850|NCT03619460|Procedure|piezoelectric extraction|Only Piezoelectric device will be used for surgical wisdom teeth extraction
15903851|NCT03619460|Procedure|conventional extraction|Only manual instruments and burs on straight handpick will be used for wisdom teeth extraction
15903852|NCT03619447|Drug|ESP block group|USG guided Erector spinae block (ESP) will perform bilaterally.
15903853|NCT03619447|Drug|serratus block group|USG guided serratus plane block will perform bilaterally
15903854|NCT03619434|Procedure|Femtosecond Laser|The laser will be used to make incisions in the cornea for the graft.
15903855|NCT03619434|Procedure|Trephine blade|A trephine blade will be used to make incisions in the cornea for the graft
15903856|NCT03619421|Dietary Supplement|Zinc supplement|25 mg
15903857|NCT03619408|Drug|Antacids|Omeprazole 1 mg/kg/dose BID or Omeprazole 1mg/kg/dose BID plus Ranitidine 3 mg/kg/dose BID
15903858|NCT03619382|Radiation|Cone Beam Computed Tomography|Computer tomography (CT) of the foot/ankle for determination of motion and morphology
15903859|NCT03619382|Radiation|Radiographs|Standard radiographs of the foot/ankle as part of the screening criteria
15903860|NCT03619369|Procedure|Circumcision|Early vs. Routine vs. Delayed Circumcision and their impact on exclusive breastfeeding rates
15903899|NCT03619005|Drug|Placebo Vaginal Insert|Daily administration of a placebo vaginal insert.
15926249|NCT03448406|Drug|Empagliflozin|Film-coated tablet
15903861|NCT03619343|Procedure|ETOIMS(Electrical Twitch Obtaining Intramuscular Stimulation)|When the abdominal wound is closed, the operator performs needle insertion at 14 sites near the incision site under the guidance of ultrasonography. When the needle is in the abdominal muscle, the operator performs muscle stimulation for about 10 seconds per needle insertion.
15903862|NCT03619330|Drug|liraglutide|In the liraglutide group liraglutide was initiated at a dose of 1.2 mg injected sc once per day and increased to 3 mg/day after 1 week.
15903863|NCT03619330|Drug|Testosterone|In the testosterone group Androtop gel 5 grams (50 mg of testosterone) was applied once a day on a dry skin.
15903864|NCT03619304|Dietary Supplement|coffee|coffee beverage
15903865|NCT03619291|Other|Aerobic Exercise|walking on a treadmill at moderate intensity, total duration 15 minutes
15903866|NCT03619291|Other|High-intensity functional training|functional exercises in circuit format at 20/10 s (work/rest) intervals, total duration 15 minutes
15903867|NCT03619291|Other|control|physical inactivity, reading sports science literature, total duration 15 minutes
15903868|NCT03619278|Other|HIVACAR|Participants will receive 5 vaccines of personalized RNA vaccine (HIVACAR01), 2 doses of 10-1074 antibodies and 3 doses of romidepsin
15903869|NCT03619278|Other|placebo|Participants will receive 5 vaccines of placebo of HIVACAR01, 2 doses of 10-1074 antibodies and 3 doses of romidepsin
15903870|NCT03619265|Dietary Supplement|Prickly pear juice|3 ounces daily for 8 weeks.
15903871|NCT03619265|Dietary Supplement|Pear-flavored juice|3 ounces daily for 8 weeks.
15903872|NCT03619252|Biological|Vaccination with pneumococcal conjugate vaccine (PCV13)|Vaccination with pneumococcal conjugate vaccine - PCV13 (Prevnar 13/Prevenar 13, Pfizer Inc) containing saccharides from serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F individually conjugated to nontoxic diphtheria cross-reactive material. Vaccination regimen: 3 doses monthly, with a booster dose 6 months later.
15903873|NCT03619252|Drug|Standard Antibacterial Prophylaxis|Levofloxacin 500 mg once daily during the median four cycles of treatment by novel agents.
15903874|NCT03619239|Drug|GX-I7|During Treatment Period, patients will receive the assigned dose of GX-I7 intramuscular injection every 4~12 weeks per cycle up to 6 cycles in the absence of unacceptable toxicity or clinically compelling evidence of disease progression.
15903875|NCT03619226|Other|test patch|the test patch consists of an adhesive patch
15903876|NCT03619213|Drug|Dapagliflozin|10 mg tablets given once daily, per oral use.
15903877|NCT03619213|Drug|Placebo|Placebo matching dapagliflozin 10 mg
15903878|NCT03619187|Drug|Ivabradine|Ivabradine will be provided in bottles (60 tablets per bottle) labeled ivabradine 5 mg and ivabradine 7.5 mg. The 2.5 mg dose of ivabradine will be achieved by subjects splitting the 5 mg tablets into equal halves.
15903879|NCT03619174|Device|Viveve Treatment|The Viveve system is a monopolar radiofrequency system that uses surface cooling and radiofrequency (RF) energy delivery to provide a non-surgical and minimally-invasive approach to generate heat within the submucosal layers of vaginal tissue while keeping the surface cool.
15903880|NCT03619161|Other|Bubbles|All bathrooms with showers or bathtubs will be cleansed with simple products (dilute bleach, dilute white vinegar, baking soda, and dilute Dawn dish soap)
15903881|NCT03619161|Other|Bleach and Bubbles|All bathrooms with showers or bathtubs will be cleansed with simple products (dilute bleach, dilute white vinegar, baking soda, and dilute Dawn dish soap).
15903882|NCT03619148|Device|High-Flow Humidified Nasal Oxygen|High-Flow Humidified Nasal Oxygen
15903883|NCT03619135|Device|Buzzy|The Buzzy is a reusable device that applies vibration to the skin surface to override the body's gate control pain pathway. It has been used effectively to reduce the discomfort of intravenous cannulation (IV placement) in pediatric patients. Also, it has been utilized to reduce the discomfort of injections in pediatric and adult patients. We are preforming this study to evaluate the effectiveness of the Buzzy in reducing the discomfort associated with intravenous cannluation (IV placement) in adults.
15903884|NCT03619135|Other|Placebo|No use of the Buzzy (standard IV access techniques)
15903885|NCT03619122|Procedure|Second Examination|The colonoscopy is passed to the cecum and then withdrawn to hepatic flexure. Then, the scopy is inserted to the cecum and withdrawn to hepatic flexure again for second foreard view examination.
15903886|NCT03619096|Procedure|tunnel technique for Root coverage with Porcine collagen Matrix|Tunnel technique for root coverage for multiple gingival recessions, using porcine collagen matrix
15903887|NCT03619096|Procedure|extended fla technique for Root coverage with Porcine collagen Matrix|Extended flap technique for root coverage for multiple gingival recessions, using porcine collagen matrix
15903888|NCT03619083|Other|SAE battery|The SAE battery yields 12 variables.
15903889|NCT03619083|Behavioral|Assessments|Assessments of their neurocognitive performance will be assessed longitudinally, at 4 time points: prior to adjuvant treatment (post-surgery); 1 month (with a +4 week window) post-chemotherapy; and again at the 12 and 24 months (with a +4 week window) post-treatment time points. These assessment time points are denoted as T1 though T4, respectively. The assessment schedule for the HC and CT- groups will be yoked against that of the CT+ cohort.
15903890|NCT03619070|Other|Resistance training, LL|In LL, the postmenopausal women will be submitted to 12 weeks of Resistance training with moderate volume (i.e. three sets per exercise) and low load (i.e. 30% of one repetition maximum)
15903891|NCT03619070|Other|Resistance training, HL|In HL, the postmenopausal women will be submitted to 12 weeks of Resistance training with moderate volume (i.e. three sets per exercise) and high load (i.e. 80% of one repetition maximum)
15903892|NCT03619070|Other|Resistance training, HVHL|In HVHL, the postmenopausal women will be submitted to 12 weeks of Resistance training with high volume (i.e. six sets per exercise) and hig load (i.e. 80% of one maximum repetition)
15903893|NCT03619070|Other|Control group, CG|The CG groups do not will performed the exercise.
15903894|NCT03619057|Other|General anesthesia with laryngeal mask i-gel|General anesthesia with laryngeal mask i-gel
15903895|NCT03619044|Other|2 FES-PET Imaging will be performed:|"before treatment initiation
~before treatment cycle 3 initiation"
15903896|NCT03619031|Other|LONG LEAVENING|a long-leavened (60 h) pizza composed of sourdough and a flour mix.
15903897|NCT03619031|Other|SHORT LEAVENING|a short-leavened (5 h) pizza composed of sourdough and a flour mix.
15903898|NCT03619031|Other|TRADITIONAL|a short-leavened (5 h) pizza composed of brewer's yeast and 00 flour.
15903901|NCT03618992|Other|Cholesterol-containing moisturizers|Commercially-available cholesterol containing topical formulations to be applied daily to the scalp, skin, lips, eyelashes, and eyebrows. Available from Skin Actives Scientific (www.skinactives.com).
15903902|NCT03618979|Biological|PPP treatment|The day prior to or the morning of the procedure, patient will have their blood drawn by a phlebotomist and processed into 5 or 10 cc of PPP depending on if there is lumbar multifidus atrophy in one or two levels. Using sterile technique and ultrasound guidance, once touching the lamina the physician will inject 2.5 cc of PPP. The physician will then repeat the procedure on the opposite side.
15903903|NCT03618979|Biological|PRP treatment|The day prior to or the morning of the procedure, patient will have their blood drawn by a phlebotomist and processed into 5 or 10 cc of 5x PRP depending on if there is lumbar multifidus atrophy in one or two levels. Using sterile technique and ultrasound guidance, once touching the lamina the physician will inject 2.5 cc of PRP and remove the needle. The physician will then repeat the procedure on the opposite side and at the next level if indicated.
15903904|NCT03618979|Biological|PRP and PL Combo treatment|The day prior to or the morning of the procedure patient will have their blood drawn by a phlebotomist and processed into 5 or 10 cc of 5x PRP and 5 or 10 cc of PL and 2 or 4 cc of 14x PRP depending on if there will be one or two levels injected. Using sterile technique, under ultrasound visualization into the lumbar multifidus and onto the lamina, the physician will inject the PRP and remove the needle. Under intermittent x-ray, epidural flow is confirmed with contrast, the physician will inject 2cc of the PL and 1cc of 0.5% ropivacaine into the epidural space. Once flow is confirmed for the epidural injection and facet with contrast, 1cc of the 14x PRP is injected into the facet joint. Procedure repeated on the opposite side and next level if indicated.
15903905|NCT03618966|Device|Neuromuscular magnetic stimulation (NMMS)|It is a non-invasive, stimulation technique that does not induce high-intensity cutaneous electric fields and does not activate skin nociceptors, thus resulting in a painless and better-tolerated procedure. rNMMS is delivered through a high-frequency magnetic stimulator connected to a conventional circular cooled coil. Magnetic stimulator is placed above the flexor muscles of the forearm. rNMMS is delivered at a 5-Hz frequency and with a 100% stimulation intensity of 100% of the maximum intensity in 140 trains of 50 stimuli. sNMMS is delivered with a sham coil producing similar acoustic sensations and mechanical skin perceptions.
15903906|NCT03618953|Biological|Ad-E6E7|Adenovirus vaccine expressing mutant HPV E6 and E7
15903907|NCT03618953|Biological|MG1-E6E7|MG1 Maraba oncolytic virus expressing mutant HPV E6 and E7
15903908|NCT03618953|Biological|Atezolizumab|monoclonal antibody; checkpoint inhibitor
15903909|NCT03618940|Behavioral|Knowledge and Attitude on burn prevention|"1.Introduction to Home Safety
~2 Fire Safety & Burn Safety (Cooking Safety, Safety around Motorcycle Exhaust &First Aid for Minor Burns
~3 Electrical Safety (Safety around Electrical & Appliances & Outlets)
~4 Firecrackers Safety (Safety around Firecrackers & Open Flames)
~5. Escaping from Fire (Escaping from Fire, Calling for Help, Stop, Drop & Roll, Emergency Calling Number (By Fire Department Kuala Lumpur), Show equipment/gear that firefighters use, Demonstrate how to use the fire extinguisher, Crawl low in smoke"
15903910|NCT03618927|Behavioral|Daily physical activity intervention|
15903911|NCT03618914|Biological|Dultavax and Vaxigrip|All the women got an influenza/DTP vaccine in order to induce acute inflammation
15903912|NCT03618901|Other|Rock Steady Boxing|Boxing programs as offered by the Rock Steady Boxing institution,
15903913|NCT03618901|Other|PD SAFEx|Progressive proprioception training.
15903914|NCT03618888|Other|Instructor-led training|The Instructor-led training contents a supervised practical training with a standard kit for training in BLS
15903915|NCT03618888|Other|Self-learning training|The self-learning training contents a standard kit for self-directed training in BLS
15903916|NCT03618875|Other|ice pack|ice pack was placed on eyelid 5 minutes prior to IVIT
15903917|NCT03618875|Other|room temperature pack|room temperature pack was placed on eyelid 5 minutes prior to IVIT
15903918|NCT03618862|Biological|Blood sampling|Peripheral venous blood collection of 56 mL during a sampling required by routine monitoring of human immunodeficiency virus infection.
15903919|NCT03618849|Device|tDCS|Real and sham tDCS/Mozart piano sonata (K.448)
15903920|NCT03618836|Other|Microbiological and biological patterns on vaginal samples|To compare the microbiological and biological patterns between groups
15903921|NCT03618823|Drug|Oxycodone|Oxycodone will be prescribed at a dose in the range of 0.025 mg/kg to 0.10 mg/kg every four hours or as needed for adequate pain management. The total supply will be limited to seven days. It will be prescribed in liquid suspension form for ease of use in pediatric populations. Subjects or parents will purchase this medication and dosage will be given to subjects in easy-to-understand language.
15903922|NCT03618823|Drug|Ibuprofen|Ibuprofen will be prescribed at 10 mg/kg to be taken every 6 hours for the first three post-operative days. After the first three days, the subject should take the ibuprofen every 6 hours as needed for pain control. The daily dose of ibuprofen is not to exceed 1200mg or more than 4 individual doses. It will be prescribed in liquid suspension form for ease of use in pediatric populations. Subjects or parents will purchase this medication and dosage will be given to subjects in easy-to-understand language.
15903923|NCT03618823|Drug|Acetaminophen|Acetaminophen will be prescribed at 15mg/kg to be taken every 4 hours for the first three days, except when sleeping. After the first three days, the subject should take the acetaminophen every 4 hours as needed for pain control. The daily dose of acetaminophen is not to exceed 5 doses in 24 hours. It will be prescribed in liquid suspension form for ease of use in pediatric populations. Subjects or parents will purchase this medication and dosage will be given to subjects in easy-to-understand language.
15903924|NCT03618810|Drug|PEGCSF first level prophylactic use|6mg (≥45kg) or 3mg (<45kg) i.h. once 24h after chemotherapy in all cycles of chemotherapy
15903925|NCT03618810|Drug|PEGCSF second level prophylactic use|6mg (≥45kg) or 3mg (<45kg) i.h. once 24h after chemotherapy in next cycle if FN or 4 grade neutropenia happened
15903926|NCT03618797|Drug|HL-PIF cap.160/2mg + Placebo|Fenofibrate pellet (as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg
15903927|NCT03618797|Drug|Livalo tab. 2mg + Placebo|Pitavastatin ca 2mg
15903961|NCT03618511|Behavioral|Reminders|Reminders: Participants will receive monthly reminder phone calls before their ART medication refill is due for six months.
15903962|NCT03618511|Behavioral|Financial Incentive and Reminders|Interaction: Participants receive both the Financial Incentives and Reminder Calls.
15903928|NCT03618784|Biological|FURESTEM-RA Inj|"The allogeneic umbilical cord blood-derived mesenchymal stem cells of each dose level as below were mixed into an IV bag containing 100 ml of sterile saline solution and the IV bag was gently massaged to obtain homogeneous mixture of the cell suspension.
~Administer the constituted cell suspension by IV infusion to a subject. The infusion should be completed in 60 minutes using infusion pump.
~Dose level 1: 5.0 x 10^7 cells /body 3 repeated intravenous injection at 4 week intervals
~Dose level 2: 1.0 x 10^8 cells /body 3 repeated intravenous injection at 4 week intervals"
15903929|NCT03618784|Other|sterile saline|"sterile saline 3 repeated intravenous injection at 4 week intervals
~Placebo were mixed into an IV bag containing 100 ml of sterile saline solution and the IV bag was gently massaged to obtain homogeneous mixture of the cell suspension.
~Administer the constituted cell suspension by IV infusion to a subject. The infusion should be completed in 60 minutes using infusion pump."
15903930|NCT03618771|Device|Total knee arthroplasty|Parts of the knee joint diseased by osteoarthritis are replaced by metal and plastic prostheses.
15903931|NCT03618758|Drug|Paclitaxel|"Intraperitoneal application of Paclitaxel Phase 1: Dose determination of Paclitaxel (Recommended Dose) Starting from 40mg/m² upto 100mg/m² maximum
~Phase 2: Intraperitoneal Paclitaxel with recommended dose"
15903932|NCT03618758|Drug|mFOLFOX6 regimen|Systemic mFOLFOX6: 5-FU(2400mg/m²), Oxaliplatin(100mg/m²), Leucovorin(100mg/m²)
15903933|NCT03618745|Device|CT brain|noninvasive medical examination or procedure that uses specialized X-ray equipment to produce cross-sectional images of the body.
15903934|NCT03618732|Other|Bilateral movement-based computer training|
15903935|NCT03618732|Other|Video-directed conventional training|
15903936|NCT03618706|Radiation|Involved-field radiotherapy|After the diagnosis of recurrences, patients will receive involved-field radiotherapy (gross tumor volume + margin) with any radiation dose scheme (≥45 Gy Biological Equivalent dose) as physician's discretion.
15903937|NCT03618693|Procedure|Spinal anesthesia|Injection of a single shot of local anesthetic bupivacaine 0.5% combined with 20 mcg fentanyl intrathecally.
15903938|NCT03618693|Device|TAP Block|TAP block with a single shot of 20ml ropivacaine 0.375% combined with 75 mcg clonidine bilaterally
15903939|NCT03618693|Other|Standard|Concomitant systemic administration of lidocaine (as an adjuvant) to the standard general anaesthesia. Lidocaine will administered initially during induction with a bolus of 1.5 mg per kgBW, followed by an infusion of 1.5 mg per kgBW per hour for 24 hours.
15903940|NCT03618667|Drug|GC1118|GC1118 (4mg/kg) will be administered by IV infusion once per week for 4 weeks(28-day cycles) up to 6 cycles, or till progression or uncontrolled toxicity.
15903941|NCT03618654|Drug|Metformin|Given PO
15903942|NCT03618654|Biological|Durvalumab|Given IV
15903943|NCT03618641|Drug|CMP-001|A molecule comprised of a 30 nucleotide strand, flanked by 10 guanines on either end. The nucleotide strand is surrounded by a Qβ viral-like protein. The intended mechanism of action of CMP-001 in oncology is the activation of TLR9 in pDC within the tumor or the tumor-draining lymph nodes (tumor-associated pDC).
15903944|NCT03618641|Biological|Nivolumab|A fully human Ig G4 antibody that blocks PD-1. Nivolumab was initially approved by the FDA for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Nivolumab has also been FDA approved to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy, as well as advanced renal cell carcinoma.
15903945|NCT03618628|Device|Carbon Fiber Off Loading Orthosis (CFO)|A finite element (FE) model will be created to determine properties that will improve CFO strength while maintaining reduction of peak plantar pressures of the CFO and plantarflexor power. A new CFO will then be fabricated for the participant. Participants will be tested in while walking barefoot, wearing their current CFO, and wearing the FE model driven CFO.
15903946|NCT03618615|Biological|artericitc surgery|biological sample (leg) from leg amputation surgery used for research
15903947|NCT03618602|Drug|Bisthianostat|Bisthianostat is a histone deacetylase inhibitor (HDAC inhibitor) for the treatment of multiple myeloma.
15903948|NCT03618589|Drug|Pregabalin|Patients in the pregabalin add-on group received 75mg of pregabalin twice a day for the first week (150 mg/day) and 150mg of pregabalin twice a day (300 mg/day) for the second week and 300mg of pregabalin twice a day (600mg/day) for subsequent 6 weeks.
15903949|NCT03618589|Drug|Opioid|Patients in the opioid group received the only opioid (5mg of oxycodone three times a day) for 8 weeks.
15903950|NCT03618576|Procedure|Balance specific exercise|Balance specific exercise consists of total 10 days' physical therapy (PT) sessions (twice per day for 60 min) after surgery. It will be conducted with a computed posturographic system for diagnostics of balance and movement skills (Balance Master® System NeuroCom®) designed to objectively quantify balance and postural function of different origin. PT (weight-bearing, strengthening, gait training, aerobic, and functional exercises) was gradually increased based on the patient's functional level. Intensive patient education by multidisciplinary rehabilitation members was also provided.
15903951|NCT03618563|Other|functional individualized therapy for teenagers with executive deficits|Intervention to improve self-perceived performance and performance satisfaction in daily activity goals that adolescent selected,
15903952|NCT03618550|Drug|pembrolizumab|Age 10-17: 2mg/kg (cap at 200mg), Age ≥ 18: 200 mg (flat) ,Day 1 of each 3 week cycle IV infusion 2-4 cycles (pre-ASCT)
15903953|NCT03618550|Drug|gemcitabine|1000mg/m^2 Days 1 and 8 of each 3 week cycle IV infusion 2-4 cycles
15903954|NCT03618550|Drug|vinorelbine|20mg/m^2 Days 1 and 8 of each 3 week cycle IV infusion 2-4 cycles
15903955|NCT03618550|Drug|liposomal doxorubicin|15mg/m^2 Days 1 and 8 of each 3 week cycle IV infusion 2-4 cycles
15903956|NCT03618550|Procedure|Stem cell mobilization and collection|Stem cell mobilization and collection will be performed as per standard MSKCC guidelines after 2-4 cycles of pembrolizumab-GVD.
15903957|NCT03618537|Drug|Ixazomib|Ixazomib at a fixed dose of 4mg on days 1, 8, and 15 of a 28-day cycle. Ixazomib will be given orally on days 1, 8, and 15 of a 28 day cycle.
15903958|NCT03618537|Drug|Dexamethasone|Dexamethasone 4mg-12mg will be allowed on days 1, 8, 15 if patients previously tolerated dexamethasone without issue.
15903959|NCT03618524|Other|Lower limb hot water immersion|Participants will undergo two interventions in separate visits: lower limb hot water (42 deg C) immersion up to the (1) ankles or (2) knees.
15926250|NCT03448406|Drug|Placebo|Film-coated tablet
15903963|NCT03618511|Behavioral|Information|Information: show the participants a video about HIV progression, mechanism of ART, the benefit of adhering to ART.
15903964|NCT03618511|Behavioral|Stigma-relieving|Stigma-Reliving: Upon recruitment, inform the participants of the results of a recent population survey regarding people's attitudes towards HIV, if they overestimate the social stigma related to HIV. This intervention intends to reduce the stigma-concern faced by the patients.
15903965|NCT03618511|Behavioral|Information and Stigma-relieving|Information and Stigma-relieving: Upon recruitment, show the participants a video about HIV progression, mechanism of ART, the benefit of adhering to ART. In addition, inform the participants of the results of a recent population survey regarding people's attitudes towards HIV, if they overestimate the social stigma related to HIV. This intervention intends to reduce the stigma-concern faced by the patients.
15903966|NCT03618498|Procedure|ILM flaps insertion techniques or free ILM flaps.|The ILM flap anchoring on the hole edge was inverted and covered the hole.Otherwise, temporal side ILM flap was used. However, if the risk of ILM flipping back was judged to be high, ILM insertion instead of ILM hole coverage was adopted.If the size of the ILM flaps was judged inadequate, the double ILM insertion technique was used, done by adding a piece of previously obtained free ILM flap on top of the inverted ILM tissue until they were securely in place.
15903967|NCT03618472|Drug|Metformin Hydrochloride 850 MG|Regular strength metformin (850 mg/tab)
15903968|NCT03618472|Drug|Placebo Oral Tablet|Starch based placebo manufatured to mimic Metformin 850 mg
15903969|NCT03618459|Other|Phone questionnaire|Patients were contacted by phone 6 months after surgery and, after oral consent, a standardized questionnaire was administered in order to inquiry about the length and nature of post-operative pain, the incidence of post-discharge pain, its characteristics, its impact on daily life, its treatment and its rate of chronicity
15903970|NCT03618446|Other|The presence of a pelvic fracture|
15903971|NCT03618433|Other|study group|The treatment protocol will consist of soft tissue massage, passive mobilization, stretching, self-stretching exercises. and shoulder proprioception .In addition to the standart exercise therapy, Kincet® video game program will be applied .
15903972|NCT03618433|Other|Control group|The control group included soft tissue massage, stretching, self-stretching, passive mobilization, coordination, posture exercises, progressive active and assisted shoulder exercises, proprioception and strengthening exercises in the exercise therapy protocol
15903973|NCT03618420|Drug|Aminohippurate Sodium Inj 20%|Diagnostic aid/agent used to measure effective renal plasma flow (ERPF)
15903974|NCT03618420|Drug|Iohexol Inj 300 mg/mL|Diagnostic aid/agent used to measure glomerular filtration rate (GFR)
15903975|NCT03618394|Dietary Supplement|MCT/ω-3-PUFA|lipid emulsion
15903976|NCT03618394|Dietary Supplement|Soybean Based|lipid emulsion
15903977|NCT03618381|Biological|second generation 4-1BBζ EGFR806-EGFRt|Autologous CD4 and CD8 T cells lentivirally transduced to express a second generation 4-1BBζ EGFR806-EGFRt
15903978|NCT03618381|Biological|second generation 4-1BBζ EGFR806-EGFRt and a second generation 4 1BBζ CD19-Her2tG|Autologous CD4 and CD8 T cells lentivirally transduced to express a second generation 4-1BBζ EGFR806-EGFRt and a second generation 4 1BBζ CD19-Her2tG
15903979|NCT03618368|Device|THERANOVA-500 dialyzer|THERANOVA-500 dialyzer is a hemofilter that enables Expanded Hemodialysis (HDx) therapy.
15903980|NCT03618368|Device|REVACLEAR-400 dialyzer|REVACLEAR-400 dialyzer is an usual hemofilter that enables conventional hemodialysis (HD).
15903981|NCT03618355|Drug|eRapa (encapsulated rapamycin)|"The eRapa (encapsulated rapamycin) drug product consists of sub-micron rapamycin particles incorporated into poly(methyl methacrylate) polymer (Eudragit® L 100 / S 100).
~This improved formulation and better bioavailability enables eRapa to consistently provide approximately 30% more drug than sirolimus (unpublished data). Improved and predictable delivery allows for consistent and sustained lower dosing, which will result in an improved toxicity profile since the latter is proven to be related to blood concentration levels. This is a phase Ib trial in low risk (Gleason score ≤7 (3+4)) prostate cancer patients under active surveillance to establish dosage safety and treatment levels."
15903982|NCT03618329|Other|Prehabilitation|exercise, nutrition and anxiety reduction in the preoperative period
15903983|NCT03618316|Drug|Imeglimin|2 singles oral doses of imeglimin 1,500 mg (one at day 1 and one at day 8)
15903984|NCT03618316|Drug|Cimetidine|400 mg of cimetidine bid from Day 5 to Day 10
15903985|NCT03618303|Diagnostic Test|PET-MRI scan|Patients will undergo combined Positron Emission Tomography and Magnetic Resonance Imaging prior to a planned invasive angiogram (performed as standard of care). During the angiogram procedure, an additional imaging test (optical coherence tomography) will be performed.
15903986|NCT03618290|Diagnostic Test|Analyze plasma free fatty acid in blood|"This study is prospectively designed with the purpose of investigating potential new lipid targets and the free fatty acids as specific markers of acute brain injury.
~Dynamic measurement of lipid profile in 3 consecutive samples at (I) the time intervals of admission, (II) 8 hours and (III) 24 hours after admission will give the opportunity of comparison mass-spectrometric analysis of highly complex plasma samples thus reducing variability between analyzed samples and allowing precise focusing on essential lipid target changes during stroke progression."
15903987|NCT03618277|Procedure|Biopsy|Micro-biopsies will be performed using a punch of 1 mm in diameter, by pulling the skin at the time of sampling, after disinfection and anesthesia.
15903988|NCT03618264|Drug|Miscible liquid of dexamethasone and ropivacaine|Intervention in this study will be peri-incisional scalp infiltration with dexamethasone, ropivacaine and normal saline miscible liquids for participants who will undergo elective craniotomy. The local infiltration solution containing 0.33mg dexamethasone and 5mg ropivacaine per milliliter will be infiltrated along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigator.
15903989|NCT03618264|Drug|Ropivacaine|Intervention in this study will be peri-incisional scalp infiltration with ropivacaine for participants who will undergo elective craniotomy. The local infiltration solution containing 5mg ropivacaine per milliliter will be infiltrated along the incision and throughout the entire thickness of the scalp before skin incision. The volume of local infiltration solution will be decided by surgeons according to the cut length, and the capacity of the solution will be recorded by investigator.
15903990|NCT03618251|Diagnostic Test|specific MRI sequences|MRI with B 2000 of diffusion weighted imaging and the coefficient of apparent diffusion
15903992|NCT03618225|Drug|Oral Duloxetine 60mg|duloxetine 60 mg orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure
15903993|NCT03618225|Drug|placebo pill|placebo pill orally 2 hours before the surgical procedure and at 24 hours after the surgical procedure
15903994|NCT03618212|Diagnostic Test|MRI|Skeletal MRI and pelvic and spinal MRI
15903995|NCT03618199|Device|Efficacy of transcranial vibrating system on mitigating dizziness and nausea during caloric testing|"Transcranial vibrating system will be on then off (or off then on in a random order) during a repeated application of the calorics testingstimulus, i.e. warm or cold water irrigated in the left (then right) ear canal. The effect of the vibrating system on 1) resulting dizziness and nausea often experienced by patients and 2) clinical parameters measured by caloric testing will be quantified."
15903996|NCT03618186|Combination Product|Tau PET scan|Patient will receive a dose of flutaucipir and be scanned appropriately
15903997|NCT03618173|Drug|Dexamethasone|IV dexamethasone at the dose of 0,2mg/kg = 0,2mL/kg of a solution of 1mg/mL max 8mg
15903998|NCT03618173|Drug|Placebos|IV saline serum at the dose of 0,2mL/kg maximum 8mL
15903999|NCT03618160|Drug|JNJ-64565111|Participants in Cohorts 1 to 3 will receive a single SC low, medium, and high dose of JNJ-64565111 respectively on Day 1, participants in Cohorts 4 to 6 will receive weekly multiple SC low, high and medium dose of JNJ-64565111 respectively on Days 1, 8, 15, and 22, under fasted conditions. Participants in Cohort 7 will receive a single SC medium dose of JNJ-64565111 on Day 1, under fasted conditions.
15904000|NCT03618160|Drug|Placebo|Participants will receive SC injection of matching placebo on Day 1 in all cohorts of Part 1 and on Days 1, 8, 15, and 22 in Part 2 under fasted conditions.
15904001|NCT03618134|Biological|Durvalumab|Given IV
15904002|NCT03618134|Procedure|Modified Radical Neck Dissection|Undergo modified radical neck dissection
15904003|NCT03618134|Other|Quality-of-Life Assessment|Ancillary studies
15904004|NCT03618134|Other|Questionnaire Administration|Ancillary studies
15904005|NCT03618134|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15904006|NCT03618134|Procedure|Transoral Robotic Surgery|Undergo TORS
15904007|NCT03618134|Biological|Tremelimumab|Given IV
15904008|NCT03618121|Device|Biofeedback plus gaming (Nevermind)|Participants will receive relaxation training from a trained therapist while receiving biofeedback through the game Nevermind. Participants receive two 30-minute sessions per week, for 4 weeks, for a total of 8 sessions.
15904009|NCT03618121|Device|Biofeedback only (The Pip)|Participants receive relaxation training from a trained therapist with biofeedack through The Pip device. The Pip connects with 4 apps, The Loom, Relax & Race, PipStressTracker, and Clarity. All 4 will be used in this study. Participants receive 2 30-minute sessions per week, for 4 weeks, for a total of 8 sessions.
15904010|NCT03618121|Behavioral|Relaxation training|Standard relaxation training protocol often used in clinical care. Participants receive 2 30-minute sessions per week, for 4 weeks, for a total of 8 sessions.
15904011|NCT03618121|Behavioral|Gaming only|"Intervention is identical to the Biofeedback plus gaming (Nevermind) intervention, but in this case participants play Nevermind without any biofeedback. Thus, they receive 2 30-minute sessions of relaxation training per week, for 4 weeks, totaling 8 sessions. During relaxation training, they will play the Nevermind game, but without attaching to any biofeedback devices."
15904012|NCT03618108|Drug|Doxycycline Capsule|doxycycline capsule
15904013|NCT03618108|Drug|Azithromycin Capsule|azithromycin capsule
15904014|NCT03618108|Drug|Rifabutin Oral Capsule|rifabutin capsule
15904015|NCT03618108|Drug|Placebo oral capsule|Placebo oral capsule identical in size and form to doxycycline
15904016|NCT03618108|Drug|Placebo Oral Tablet|Placebo oral capsule identical in size and form to azithromcyin
15904017|NCT03618108|Drug|Placebo oral capsule|Placebo oral capsule identical in size and form to rifabutin
15904018|NCT03618095|Device|LOTUS Edge Valve System|TAVR with the LOTUS Edge Valve System
15904019|NCT03618082|Drug|Anesthesic agent guided by ANI (Interventional Group)|Anesthesic agent guided by ANI (Interventional Group) The remifentanil administration will be piloted by the ANI, as well as the prophylactic administration of morphine at the end of the intervention.
15904020|NCT03618082|Drug|Administration of the lowest effective concentration of desflurane (Interventional Group)|Administration of the lowest effective concentration of desflurane (Interventional Group) Desflurane will be administered with a targeted purpose of minimal alveolar concentration (MAC).
15904021|NCT03618069|Diagnostic Test|CCI scanning (CTA, cardiac CT), and MRI scanning|Scanning
15904022|NCT03618056|Biological|AIDSVAX® B/E|Administered by intramuscular injection
15904023|NCT03618043|Drug|SH-1028|Starting dose 60mg,oral administered once daily.If tolerated subsequent cohorts will test increasing doses (120mg,180mg,240mg,320mg) of SH-1028.
15904024|NCT03618030|Drug|PRC-063 oral capsules|Daily dose
15904025|NCT03618030|Drug|Placebo oral capsules|Daily dose
15904026|NCT03618017|Behavioral|CCC website|ConnectedCancerCare (CCC) is a web-based guide to support survivorship care for women who have been treated for early-stage (stages 0-II) breast cancer. It encourages patients to utilize team-based care by oncologists and primary care physicians and provides them with the information on cancer surveillance, screenings and preventive healthcare during survivorship.
15904027|NCT03618017|Behavioral|Static care plan|"The control is a static survivorship care plan template in PDF format that includes information similar to what an oncologist currently provides as standard of care."
15904028|NCT03618004|Other|Experimental group|"The intervention lasted 17 minutes each session, 2 weekly sessions were carried out, during 4 weeks. The training started with a warm-up on the hand bike without a load for 5 minutes. Later, we did a work of 3 series of 30 seconds, in maximum power, with 5 minutes of rest between them. The intensity was calculated by 0.048 kp.kg.
~The subjects of the experimental group made use of the restriction of blood flow, using a pressure cuff coupled in the most proximal region of the arm, 10 cm wide. The pressure was calculated based on the initial systolic pressure of the subjects."
15904029|NCT03618004|Other|Control group|"The intervention lasted 17 minutes each session, 2 weekly sessions were carried out, during 4 weeks. The training started with a warm-up on the hand bike without a load for 5 minutes. Later, we did a work of 3 series of 30 seconds, in maximum power, with 5 minutes of rest between them. The intensity was calculated by 0.048 kp.kg.
~The subjects in the control group did not use pressure cuffs."
15904030|NCT03617991|Other|Exercise Group|An 8-week home exercise program will be given to the participants. The program is designed to have four phases, progressed every two weeks. The participants will receive and email from study personnel every two weeks with new videos detailing the progression of exercises. The participants will be given all of the equipment to complete the exercises. The exercises will include balance and strength training exercises for the core and lower extremity.
15904031|NCT03617978|Procedure|Hemodynamics parameters|real-time evaluation of cardiac output parameters using the ICON device
15904032|NCT03617965|Diagnostic Test|Platelet count|All patients who are admitted to the intensive care unit of this hospital and meet the inclusion criteria will be followed for 90 days. There will be a complete review of the file that includes the entire hospitalization, in order to collect demographic information, clinical, laboratory reports, and imaging reports among others. Patients who are transferred to other units due to clinical improvement will be followed peripherally by the internal medicine department and the patients who are released due to clinical improvement will be contacted via telephone or in their next outpatient consultation with an internist.
15904033|NCT03617952|Behavioral|P3 Bio Intervention|Two types of improved biomass burning cookstoves (ACE1 and Greenway Jumbo) are offered to participants in both arms at varying prices.
15904034|NCT03617939|Procedure|Biospeciman Collection|Collection of blood, tissue, and other biological samples.
15904035|NCT03617939|Other|Survey Assessments|Data taken from patient surveys and assessments, including quality of life.
15904036|NCT03617939|Other|Medical Chart Reviews|Data taken directly from the patients' medical charts.
15904037|NCT03617926|Device|X92001666|the X92001666 product is a lotion to be applied on dry hair for 15 minutes and then washed out using shampoo. The product is to be applied on Day 0 and repeated again on Day 7.
15904038|NCT03617926|Other|RID shampoo|Active Comparator: RID shampoo The RID shampoo is to be applied on dry the hair for 10 minutes and then rinsed out with water. the product is to be applied on Day 0 and repeated again on Day 7.
15904039|NCT03617913|Drug|Avelumab|Given IV
15904040|NCT03617913|Drug|Cisplatin|Given IV
15904041|NCT03617913|Drug|Fluorouracil|Given IV
15904042|NCT03617913|Drug|Mitomycin|Given IV
15904043|NCT03617913|Other|Quality-of-Life Assessment|Ancillary studies
15904044|NCT03617913|Radiation|Radiation Therapy|Undergo RT
15904045|NCT03617900|Drug|Ginger|Ginger extract is contains 100 mg/capsules. Use 2 capsules 3 times/day
15904046|NCT03617900|Drug|Placebo oral capsule|Lactose monohydrate 400 mg/capsules
15904047|NCT03617900|Drug|Paracetamol|500 mg paracetamol. use in need
15904048|NCT03617887|Other|Experimental group|"Plank exercise, Lateral plank exercise, Bird dog exercise, Pelvic drop exercise, and Stabilization of the middle gluteus in the knee valgus.
~The intervention consisted of sessions of approximately 20 minutes, taking place 2 days a week, for 8 weeks. The exercises were performed at the beginning of the training session, and consisted of a work of the abdominal region in the control group, and a specific work of gluteus medius, added to the previous one, in the experimental group."
15904049|NCT03617887|Other|Control group|Plank exercise, Lateral plank exercise and Bird dog exercise. The intervention consisted of sessions of approximately 20 minutes, taking place 2 days a week, for 8 weeks. The exercises were performed at the beginning of the training session, and consisted of a work of the abdominal region.
15904050|NCT03617874|Other|PC4PrEP- Intervention Clinics|PC4PrEP is a comprehensive, multi-level, structural and sustainable intervention designed to address barriers at system, provider, and user levels to increase PrEP uptake.
15904051|NCT03617874|Other|Standard of Care Clinics|The standard of care model is the model approved by the health system for their health care clinics.
15904052|NCT03617861|Drug|Human Secretin|Injected once over one minute
15904053|NCT03617861|Drug|Placebo|Injected once over one minute
15904054|NCT03617835|Drug|Spesolimab|single-dose
15904055|NCT03617809|Procedure|Preoperative warming|The prewarming time will not be decided by the clinical investigator. Prewarming time will depend on the time the patient has to wait before entering in the operating room.
15904056|NCT03617783|Drug|Prebiotin|Prebiotin (12g/day), an oligofructose-enriched inulin (OEI)
15904057|NCT03617783|Drug|Placebo|placebo-OEI
15904058|NCT03617770|Behavioral|Sleep Opt-In|8-week intervention that includes a wearable sleep tracker, didactic content, smartphone application and counseling
15904059|NCT03617770|Behavioral|Healthy Living|8-week intervention that includes weekly telephone counseling on healthy living.
15904060|NCT03617757|Diagnostic Test|Oral Glucose Tolerance Test|Patients will be invited to have oral glucose tolerance test. 2mL blood will be taken for analysis at 0 minute and 120 minutes.
15904061|NCT03617757|Diagnostic Test|HbA1c|2mL blood will be taken for analysis of HbA1c.
15904062|NCT03617744|Procedure|Sleeve gastrectomy|Open sleeve gastrectomy
15904063|NCT03617731|Drug|Lenalidomide|25 mg per os on day 1-14 and d22-35 in induction cycle 1-3 (Arms IA and IB) 10 mg p.o. on day 1-28 in maintenance cycle 1-3, 15 mg p.o. on day 1-28 in maintenance cycle 4-39 (Arms IIA and IIB)
15904064|NCT03617731|Drug|Bortezomib|all arms: 1,3 mg/m^2 subcutaneous on day 1, 4, 8, 11, 22, 25, 29 32 in 3 induction cycles
15904065|NCT03617731|Drug|Dexamethasone|20 mg per os on day 1,2 and 4,5 and 8,9 and 11,12 and 15 and 22,23 and 25,26 and 29,30 and 32,33 in induction cycles 1-3 (Arms IA and IB). Maintenance cycle 1 on day 1, 8, 15, 22 Dexamethasone 20 mg/d per os (Arm IIA). In Arm IIB Dexamethasone 20 mg i.v. on days of Isatuximab infusion in the first maintenance cycle (d 1, 8, 15, 22), dexamethasone will be administered intravenously as part of the premedication. If an isatuximab dose is skipped or discontinued dexamethasone should be administered orally.
15904066|NCT03617731|Drug|Isatuximab|10 mg/kg in the vein( i.v) on day 1,8,15, 22, 29 in induction cycle 1 on day 1, 15 and 29 in induction cycle 2 and 3 (Arm IB). 10 mg/kg i.v. on day 1,8, 15 and 22 in maintenance cycle 1, 10 mg/kg i.v. on day 1 and 15 in maintenance cycle 2 and 3, 10 mg/kg i.v. on day 1 in maintenance cycle 4 - 39 (Arm IIB)
15904067|NCT03617718|Drug|Glycine Buffer|Subjects will be asked to perform an Inhaled Glycine Buffer followed by a series of Pulmonary Function Tests (PFTs) and then a research bronchoscopy will happen at visit 3.
15904068|NCT03617705|Device|Skyn Monitor Lab Session 1|Participants will be instructed to wear the Skyn wrist-worn alcohol monitor and drink 3 beers over the course of an hour and a half. BrAC will be measured every 15 minutes throughout the session.
15904069|NCT03617705|Device|Skyn Monitor Field Test with EMA App|After Skyn Monitor Lab Session 1, participants will be instructed to wear Skyn monitor for the rest of the day and the following two weeks. Participants will also enter information on each drinking session during the two week time using a mobile-based ecological momentary assessment (EMA) to collect real-time data in daily life.
15904070|NCT03617705|Device|Skyn Monitor Lab Session 2|Participants will be instructed to wear the Skyn wrist-worn alcohol monitor and drink 3 beers over the course of an hour and a half. BrAC will be measured every 15 minutes throughout the session. Participant will also complete device acceptability and usability survey.
15904071|NCT03617679|Drug|Rucaparib|Participants allocated to the active ingredient arm will receive Rucaparib twice daily, 600mg, to be take by mouth. Patients will take the medication continuously over a 28 day cycle, until disease progression or other indication of discontinuation. Medication should be taken around the same time every day, with 8 or more ounces of water.
15904072|NCT03617679|Drug|Placebo Oral Tablet|Participants allocated to the placebo arm will receive a placebo tablet (that looks identical to the active ingredient tablet) twice daily, 600mg, to be take by mouth. Patients will take the medication continuously over a 28 day cycle, until disease progression or other indication of discontinuation. Tablet should be taken around the same time every day, with 8 or more ounces of water.
15904073|NCT03617666|Drug|Avelumab|Patients with newly diagnosed cHL will receive 4 doses of single agent avelumab intravenously given every 2 weeks.
15904074|NCT03617653|Diagnostic Test|Group A|Refer to detailed study Description
15904075|NCT03617627|Behavioral|Self-management intervention|Self-management intervention will include presentation and discussion of various topics regarding chronic pain mechanisms and pain self-monitoring. The intervention will also incorporate a task-oriented approach focused on relevant activities in order to acquire coping skills.
15904076|NCT03617614|Behavioral|Collaborative Care Model|"Trained care managers (CM) work collaboratively with patients, caregivers, and primary care providers to provide education, care navigation and behavioral activation. The latter includes a stepped psychotherapy intervention called ENGAGE, that focuses on reward exposure engagement in meaningful, rewarding activities for patients. Patients (home) visits are delivered over a period of 6 to 16 weeks. Progress is assessed with standardized measures for depression (PHQ-9), anxiety (GAD-7) and functioning (WHO-DAS). Furthermore, patients are presented by the CM at Systematic Case Review meetings where an integrated team of medical, psychiatric and allied health professionals work collaboratively to review the patient's goals and treatment to formulate a care plan and recommendations."
15904077|NCT03617614|Behavioral|Mood Consultation|A meeting with a psychiatrist to do assessment, provide education and make recommendations regarding the care of the patient for the Primary Care Provider.
15904078|NCT03617601|Diagnostic Test|MET|Testing of the metabolic equivalent of task before aortic procedure
15904079|NCT03617588|Drug|Gallium-68 THP-PSMA|Subjects will undergo a Gallium-68 THP-PSMA scan in addition to standard of care monitoring. The results of this scan may influence the patient management plan.
15904080|NCT03617575|Dietary Supplement|apo-Lactoferrin|1.41 g of apo-Lactoferrin will be given together with 1.42 mg FeSO4 (0.08 mg of iron naturally in apo-Lf [total of 1.5 mg iron]) in a maize porridge (extrinsically labeled)
15904081|NCT03617575|Dietary Supplement|holo-Lactoferrin|1.41 g of holo-Lactoferrin (intrinsically labeled with 1.5 mg 57Fe) will be given together in a maize porridge
15904082|NCT03617575|Dietary Supplement|FeSO4|1.5 mg FeSO4 as 54Fe in a maize porridge
15904083|NCT03617575|Dietary Supplement|1. FeSO4|10 mg 56Fe + 2 mg 54Fe Is the 1. FeSO4 meal in maize porridge
15904084|NCT03617575|Dietary Supplement|FeSO4 after 1 day break|10 mg 56Fe + 2 mg 57Fe Is the 2. FeSO4 in maize porridge with a 1 day washout period
15904085|NCT03617575|Dietary Supplement|FeSO4 after 2 day break|10 mg 56Fe + 2 mg 58Fe Is the 3. FeSO4 in maize porridge with a 2 day washout period
15904088|NCT03617536|Drug|CR845 0.25 mg Oral Tablet|CR845 0.25 mg medication taken orally 1 time/day
15904089|NCT03617536|Drug|CR845 0.5 mg Oral Tablet|CR845 0.5 mg medication taken orally 1 time/day
15904090|NCT03617536|Drug|CR845 1 mg Oral Tablet|CR845 1 mg medication taken orally 1 time/day
15904091|NCT03617536|Drug|Placebo Oral Tablet|Placebo tablet taken orally 1 time/day
15904092|NCT03617523|Biological|Fluzone Quadrivalent vaccine, 2018-2019 formulation|Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
15904093|NCT03617523|Biological|Flublok Quadrivalent vaccine, 2018-2019 formulation|Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
15904094|NCT03617523|Biological|Fluzone High-Dose vaccine, 2018-2019 formulation|Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
15904095|NCT03617510|Drug|Felbinac Trometamol Injection|Felbinac Trometamol Injection will be infused IV in 100 mL normal saline,in a 30-minute period using a programmable pump.Three days after the single dose,the drug was given 7 times,3 times/day,once every 8 hours. It means the drug was given 3 times on D3 and D4,once on D5.
15904096|NCT03617510|Drug|Placebos|Normal saline will be infused IV in 100 mL normal saline,in a 30-minute period using a programmable pump.Three days after the single dose,the Placebo was given 7 times,3 times/day,once every 8 hours.It means the Placebo was given 3 times on D3 and D4,once on D5.
15904097|NCT03617497|Diagnostic Test|scalp EEG and polysomnography|48 hour 22 channel EEG with polysomnography
15904098|NCT03617497|Diagnostic Test|scalp EEG with foramen ovale electrodes with polysomnography|long-term scalp EEG with additional foramen ovale electrodes with polysomnography
15904099|NCT03617484|Drug|Bortezomib|Bortezomib will be administered subcutaneously at a dose of 1.3 mg/m^2 on days 1, 4, 8, and 11 of each 21-day cycle.
15904100|NCT03617484|Drug|Ibrutinib|Ibrutinib will be administered orally at a dose of 560 mg daily for each 21 day cycle.
15904101|NCT03617471|Procedure|Venopuncture for PK profiling|Blood samples at T0, T0.5, T1, T2, T4, T6
15904102|NCT03617458|Drug|Metformin|Metformin is a drug has been on the market for several decades and is considered first line therapy for diabetes mellitus type 2.
15904103|NCT03617458|Drug|Placebo|A treatment with no active ingredients or therapeutic effect.
15904104|NCT03617458|Device|mHealth Intervention|Our Health Insurance Portability and Accountability Act (HIPPA) compliant texting platform is linked to the Fitbit Application Program Interface. Real time activity data will be transmitted from the subject's smartphone to our mHealth platform via cellular network.Subjects assigned to the texting arm will receive 3 texts/day in sync with their preferred morning, lunch, and evening leisure schedule, which is defined at enrollment. These texts will use personal, disease-specific, and provider information to deliver 2 types of messages customized to the current step count and sent in equal proportion. Messages are designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.
15904105|NCT03617458|Device|Usual Care|Our HIPPA compliant texting platform is linked to the Fitbit Application Program Interface. Real time activity data will be transmitted from the subject's smartphone to our mHealth platform via cellular network.
15904106|NCT03617445|Drug|FMT oral capsule|FMT oral capsules, single dose of 5 capsules
15904107|NCT03617445|Drug|Oral Vancomycin|Oral Vancomycin 125 mg capsules every 6 hours for 10 days, followed by 125 mg oral placebo every 12 hours for 7 days, followed by 125 mg oral placebo once daily for 7 days, followed by 125 mg oral placebo every 3 days for 14 days
15904108|NCT03617445|Drug|FMT oral placebo|Placebo oral capsules, single dose of 5 capsules
15904109|NCT03617445|Drug|Oral Vancomycin placebo|Placebo oral vancomycin capsules every 6 hours for 10 days, followed by 125 mg oral vancomycin every 12 hours for 7 days, followed by 125 mg oral vancomycin once daily for 7 days, followed by 125 mg oral vancomycin every 3 days for 14 days.
15904110|NCT03617432|Drug|Chidamide|Chidamide 15mg orally BIW. Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
15904111|NCT03617432|Drug|Cyclophosphamide|Cyclophosphamide(750mg/m2) was administered intravenously on d1. Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
15904112|NCT03617432|Drug|Doxorubicin|Doxorubicin (50mg/m2)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
15904113|NCT03617432|Drug|Vincristine|Vincristine (1.4mg)was administered intravenously on d1.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
15904114|NCT03617432|Drug|Etoposide|Etoposide (100mg/m2) was administered intravenously on d1,2,3.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
15904115|NCT03617432|Drug|Prednisone|Prednisone (100mg)was administered by oral on d1-5.Six cycles of therapy will be administered, and each cycle of treatment is 21 days.
15904116|NCT03617419|Device|GE VScan Access R2 Ultrasound System|A diagnostic ultrasound imaging system manufactured by the study Sponsor.
15904117|NCT03617419|Device|GE Corometrics 170 Series Fetal Monitor|A reference device to record a continuous fetal heart rate.
15904118|NCT03617419|Device|GE Corometrics 170 Series Fetal Monitor|A reference device for verification of scanning the fetal heart.
15904119|NCT03617406|Diagnostic Test|Volume Challenge|Addition volume challenge with passive leg raising method in LDDSE as well as administration of normal saline and dobutamine during TEE
15904120|NCT03617380|Other|Usual Care|patients participating Usual Care discharge services
15904121|NCT03617380|Other|PharmD TOC|patients participating in a community pharmacy-based Transitions of Care Program (PHARMD-TOC)
15904122|NCT03617367|Biological|daxibotulinumtoxinA for injection|DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline.
15904123|NCT03617354|Procedure|Total Laparoscopic Hysterectomy|The trainee gynaecologists are undertaking a training program in performing Total Laparoscopic Hysterectomy
15904124|NCT03617341|Procedure|Brain MRI|Brain MRI will be taken at the time of initial diagnosis, first- and second-line treatment failure. Therefore, the investigators expect that early detection of brain metastases before the onset of symptoms will affect the overall prognosis of MBC patients.
15904125|NCT03617328|Biological|6MHP|6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
15904126|NCT03617328|Drug|Montanide ISA-51|Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
15904127|NCT03617328|Drug|polyICLC|polyICLC, local adjuvant
15904128|NCT03617328|Drug|CDX-1127|CDX-1127, anti-CD27 monoclonal antibody
15904129|NCT03617315|Drug|Hylauronic Acid|Schirmer Test, BUT test and OSDI test. Previous and After treatment
15904130|NCT03617302|Drug|Experimental: Nitrate-containing|Experimental
15904131|NCT03617302|Drug|Placebo: Nitrate-depleted|Placebo
15904132|NCT03617289|Drug|Magnesium Sulfate|
15904133|NCT03617289|Drug|D5W|
15904134|NCT03617263|Drug|Saroglitazar Magnesium 4 mg Tablet|Patients randomly assigned to this group will receive Saroglitazar Magnesium orally once daily for 24 weeks.
15904135|NCT03617263|Drug|Placebo|Patients randomly assigned to this group will receive Placebo tablet orally once daily for 24 weeks.
15904136|NCT03617250|Other|Disease Activity Score-28|Assessment of neutrophil-lymphocyte ratio and platelet-lymphocyte ratio and their association with Disease Activity Score-28
15904137|NCT03617237|Other|Retrospective Populations|"All patients who are currently treated by any physician at the University of Texas Southwestern campus Aston Clinic, Seay Clinic, PHHS Clinic, Moncrief Radiation Oncology, St. Paul West Campus Radiation Oncology, East Radiation Oncology Clinic will be included in the registry. The data from the charts will be entered into a password protected excel spreadsheet. The charts will be identified by name, medical record number, date of birth, and social security number.
~The research involves no more than minimal risk to the subjects.
~The waiver will not adversely affect the rights and welfare of the subjects.
~The research could not practicably be carried out without the waiver.
~Whenever appropriate, the subjects will be provided with additional pertinent information after participation."
15904138|NCT03617224|Radiation|TSEBT|"The regimen includes a rule-based 3+3 design for escalating regimen intensity of combined TSEBT and pembrolizumab."
15904139|NCT03617224|Drug|TSEBT and pembrolizumab|Dose regimens are sequential therapy of TSEBT with Pembrolizumab.
15904140|NCT03617198|Biological|CD4 CAR+CCR5 ZFN T-cells|A dual cohort, open-label, randomized study of the safety and tolerability of a single infusion of autologous T cells genetically modified to express a CD4 chimeric antigen receptor while also having zinc finger nuclease-mediated disruption of the CCR5 gene
15928438|NCT03431623|Biological|CKD-11101(Darbepoetin alfa)|
15904141|NCT03617185|Other|High Intensity Interval Training (HIIT)|Patients will complete a HIIT training protocol of a total of 10 x 1 min intervals at 90% heart rate (HR) max. They will continue this training protocol, 3 sessions a week (2 supervised and 1 unsupervised), for 24 months.
15904142|NCT03617185|Other|Routine Exercise|Patients will receive counseling regarding exercise as a routine part of their participation in the bariatric surgery clinic. Specifically, they are counseled to participate in 60 min of aerobic exercise daily in addition to 2-3 non-consecutive days of strength training workouts every wk. Patients are encouraged to contact the bariatric conditioning program, obtain a gym membership, purchase exercise equipment, join a walking group, and/or sign up for fitness classes (employer or city parks and recreation).
15904143|NCT03617185|Procedure|Bariatric surgery|Patients will undergo bariatric surgery as part of their routine care
15904144|NCT03617172|Drug|Misoprostol 100Mcg Tab|Two 100mcg capsules twice per day
15904145|NCT03617172|Other|Placebo|Two capsules twice per day
15904146|NCT03617159|Device|Magnetic Resonance Imaging|Diagnostic Modality
15904147|NCT03617146|Behavioral|Health coaching|The intervention will seek to help participants express their diabetes emotional needs and to work with them to figure out what can be done to meet those needs. Depending on the unique needs of each participant, the coaching approach for this study will include: improving motivation and self-efficacy for diabetes management using motivational interviewing and appreciative inquiry; building trust and rapport through mindful listening, open-ended inquiry, and perceptive reflections; and expressing empathy through nonviolent communication. Each participant will receive eight individual coaching sessions over a five month period. All coaching sessions will be delivered over the phone (i.e. telecoaching). The coaching intervention will be done by a certified health and wellness coach.
15904148|NCT03617146|Other|Diabetes Distress-specific Education|A diabetes distress-specific education that explains what diabetes distress is, why it matters, and its four domains. In addition, the participant is given feedback on his or her distress score and advised on ways to deal with the areas of greatest distress. Participant is linked with resources to overcome any expressed needs. The education is provided by a trained medical assistant.
15904149|NCT03617133|Radiation|Increased use of IC/IS technique in BT|In EMBRACE II, the improved therapeutic window (through increased application of IC/IS) will be exploited for tumour dose-(de-)escalation and/or OAR dose de-escalation. In tumours with large residual CTVHR volumes at time of brachytherapy, dose-escalation has the potential to improve local control significantly. In limited size CTVHR volumes dose-de-escalation will be performed since dose de-escalation has minor impact on local control while it has potential to reduce morbidity. The strategy of EMBRACEII is to aim for an application of the IC/IS technique in at least 20% of the patients in each institution. The threshold of 20% is relevant for a classical stage distribution of ~20% IB, ~50% IIB, ~20% IIIB and ~10% others. If a given patient population includes significantly higher proportions of limited or extensive disease, the threshold of 20% IC/IS applications must be adapted.
15904150|NCT03617133|Radiation|Reduction of vaginal source loading|A multicenter investigation in 50 EMBRACE patients from 3 institutions (Mohamed SM. et al, in submission 2015) shows that reduced loading in ring/ovoids and increased loading in tandem (and needles when available) can be applied without compromising CTVHR and GTVres dose. Decrease of relative vaginal loading from a mean of 50% to 33% had potential to reduce ICRU recto-vaginal dose by a mean of 4±4Gy, and furthermore, bladder and rectum doses could be reduced by 2-3Gy with the same re-arrangement of loading. Similar evidence is available from a study on simulation of different intracavitary standard loading patterns in EMBRACE patients, where it was shown that limited size tumours could often be covered by tandem loading alone (Nkiwane KS. et al. 2013).
15904151|NCT03617133|Radiation|Systematic utilisation of IMRT|Many institutions deliver 3D conformal radiotherapy (3D CRT) based on a four-field box technique although IMRT has been available for a number of years. The practice in EMBRACEI has been utilisation of IMRT and 3D CRT in 27% and 73% of the patients, respectively. However, EMBRACE morbidity data as well as data published by Mundt et al (Mundt AJ. et al. 2003) indicate that IMRT significantly reduces the incidence of bowel morbidity, and therefore IMRT is considered as instrumental for reducing the incidence of bowel morbidity and with a potential also to be beneficial for urinary morbidity.
15904152|NCT03617133|Radiation|Utilisation of daily IGRT (set-up according to bony structures)|PTV margins of 10 mm to the elective lymph node target are currently applied in many institutions. This margin is related to set-up uncertainties with patient positioning performed based on skin marks. However, currently, most institutions have in-room imaging available which makes it possible to perform daily imaging and couch correction according to fusion on bony anatomy. With daily imaging, bony image fusion, and couch correction, a margin reduction from 10mm to 5mm can be performed without compromising target coverage (Laursen LV. et al. 2012). The 5mm margin reduction has potential to decrease the volume irradiated to 43Gy by approximately 500cm, which is expected to decrease bowel morbidity by ~50%.
15904153|NCT03617133|Radiation|EBRT target concept related to the primary tumor (CTV-T) and internal motion; concepts for OAR contouring|New target concepts are introduced for EBRT related to primary tumor: initial CTV-T, initial CTV-HR, initial CTV-LR and ITV-LR. Use of this novel contouring approach in conjunction with available MRI allows to target safely the visible tumor (CTV-T) and the high risk region (CTV-HRintitial) while consenting for dose to a low risk region (CTV-LRinitial). Anatomical changes due to organ filling variation and cervix/uterus position are considered. ITV-LR is outlined using planning scan and MR images in patients with MRI in treating position while a fixed margin is added to the CTV-LR initial in patients with only diagnostic MRI. New concepts are introduced for OAR contouring. Bowel loops are outlined in one volume restricted to the outer contour, including the mesenterium, for better approximation of the bowel volume and dose constraints. Rectum/sigmoid structures are contoured distinctly. Vaginal lower border is 2,5cm from the caudal extend of the tumor (2cm ITV-LR initial + 0,5cm PTV).
15904154|NCT03617133|Radiation|EBRT dose prescription and reporting|There is currently a significant variation with regard to EBRT dose and fractionation in the EMBRACE study with doses ranging from 45Gy to 50Gy and being delivered in 25-30 fractions. Furthermore, there is a wide variety of lymph node boosting strategies. In EMBRACEII, the EBRT dose and fractionation to the elective lymph node CTV and initial CTV-T is fixed at 45Gy in 25 fractions, and lymph node boosting must be performed as a simultaneous integrated boost. The dose de-escalation from 50Gy to 45Gy has potential to reduce morbidity. A system of reporting dose to targets and OARs is introduced in terms of dose volume parameters and a system of point dose reporting for the vagina.
15928439|NCT03431623|Biological|NESP(Darbepoetin alfa)|
15904155|NCT03617133|Radiation|Adaptation of EBRT nodal elective CTV according to risk of nodal and systemic recurrence|"EMBRACEII applies a risk adapted target concept for nodal CTV. This target concept is based on pattern of nodal recurrence analysis which shows 50% of recurrences beyond the classical L5/S1 cranial pelvic field border. A target volume Large Pelvis is defined for intermediate risk patients and includes internal, external, common iliac, obturator and presacral nodes. For high risk patients, defined as common iliac or >2 nodes involved, the para-aortic region is included. For low risk patients, defined as stage IA/IB1/IIA1, N0, small cell carcinoma (SCC), no uterine invasion, Small Pelvis is defined which is Large Pelvis without common iliac nodes. Intermediate risk is defined as not high and not low risk."
15904156|NCT03617133|Drug|Systemic application of simultaneous chemotherapy|According to international standard and evidence, simultaneous chemotherapy (CHT) (min. 5x40 mg/m2 cis Platinum) was prescribed in the EMBRACE protocol for all patients, who qualify for its administration. Certain rules were given for adaption according to international guidelines. 90-95% of EMBRACE patients received simultaneous CHT. Most of the EMBRACE cohort is consecutive patients representing the cervix cancer patient population in the respective centers. About 70% of patients received ≥5 cycles, while 30% received 0-4 cycles. CHT has impact on systemic control, which is pronounced in high risk patients (node positive and/or stage III/IV) with a 20% difference in systemic recurrence. A center effect has been found in the ability to administer chemotherapy with 15-85% of the patients receiving ≥5 cycles of CHT. To reach optimal outcome, particularly in the high risk group, the EMBRACEII protocol also focusses on appropriate administration of CHT following international guidelines.
15904157|NCT03617133|Other|Reduction of overall treatment time|Several studies indicate that maintaining an overall treatment time (OTT) of <=50 days is important for local control. RetroEMBRACE data confirms that OTT remains of importance in the realm of IGABT. As there is significant variation of OTT across patients and institutions in retroEMBRACE, the EMBRACEII study aims to reduce the OTT so that the majority of patients (>80%) will adhere to the <=50 day threshold. The measures to reduce OTT in EMBRACE is to systematically apply 25 fractions of EBRT including lymph node boost, and furthermore to carefully plan the BT schedule, so that brachytherapy is delivered towards the end of EBRT and/or directly after EBRT.
15904158|NCT03617120|Device|Ergonomic Brace vs hard brace|"Visit 1:
~Usual check-up: standing in-brace radiograph of hard brace and doctor consultation
~Pressure measurement of participant wearing their hard brace
~Visit 2:
~Brace Questionnaire (BrQ) for hard brace; Trunk Appearance Perception Scale (TAPS)
~3D body scanning (before wearing the Ergonomic Brace)
~Fitting of the Ergonomic Brace
~Pressure measurement of participant wearing the Ergonomic Brace (instant)
~Pressure measurement of participant wearing the Ergonomic Brace (after 2 hours)
~3D body scanning (after wearing the Ergonomic Brace for 2 hours)
~Brace Questionnaire (BrQ) for the Ergonomic Brace
~Visit 3:
~Standing in-brace radiograph of the Ergonomic Brace
~Doctor consultation"
15904159|NCT03617107|Other|reverse total shoulder arthroplasty|reverse total shoulder arthroplasty
15904160|NCT03617094|Device|Early percutaneous vertebroplasty (EPV)|Treatment consists of percutaneous acrylic bone cement injection using a trocar under scope control and general anesthesia.
15904161|NCT03617094|Device|Standard Conservative treatment (CT)|Treatment consists of using a made-to-measure 3 point thoracolumbar corset,that is worn for 3 months: night and day during the first 6 week period of the treatment, and then only the day for the next 6 week period.
15904162|NCT03617081|Drug|NNC0113-2023|Participants will receive dose levels of 1 mg, 2 mg, 4 mg, 8 mg, 16 mg or 32 mg of NNC0113-2023 orally. Each participant will receive only one dose.
15904163|NCT03617081|Drug|Placebo (NNC0113-2023)|Participants will receive NNC0174-0833 matched placebo orally.
15904164|NCT03617068|Drug|Cocos Nucifera Whole|Applying the Cocos Nucifera Whole cream for 2 weeks, on both of arms. We evaluated the score of hand dermatitis using Hand Eczema Score Index ( HECSI), transepidermal water loss (TEWL), and Skin capacitance
15904165|NCT03617068|Drug|Cocos Nucifera Whole|For dermatopharmacokinetic evaluation using tape/ skin stripping
15904166|NCT03617055|Diagnostic Test|serum cystatin c|Blood sample for serum cystatin c will be taken on the first and third days of life for all neonates with clinical or laboratory signs of perinatal asphyxia who are admitted to NICU for early detection of AKI in the study group.
15904167|NCT03617029|Device|Microcoil|Needle localization with microcoil
15904168|NCT03617029|Drug|Lipiodol|Needle localization with contrast injection
15904169|NCT03617016|Drug|Domperidone|Participants will receive domperidone tablets orally.
15904170|NCT03617016|Drug|Placebo|Participants will receive matching placebo to domperidone tablets orally.
15904171|NCT03617003|Drug|WST11 mediated vascular targeted phototherapy (VTP)|All patients will receive intravenous administration of WST11 at a dose of 4 mg/kg, infused over 10 minutes while patients are under anesthesia during their endoscopy procedure, followed by immediate laser light application.
15904172|NCT03617003|Procedure|Endoscopy|Endoscopy of the bladder
15904173|NCT03616990|Behavioral|TASC Service Linkages - Discharge Area Only|Individuals will meet with TASC Care Coordinators in the discharge area of the Cook County Jail. Individuals will be screened for housing, health and behavioral health needs and then linked to appropriate community-based services.
15904174|NCT03616990|Behavioral|SRC Overnight Stay|Individuals receiving SRC services will have the option to stay at the SRC overnight. At the SRC, individuals will be able to rest, have a meal, receive a change of clothes, and take a shower in a therapeutic, non-coercive environment.
15904175|NCT03616990|Behavioral|TASC Services Linkages - SRC Onsite|While at the SRC, individuals will meet with TASC Care Coordinators. Individuals will be screened for housing, health and behavioral health needs and then linked to appropriate community-based services.
15904176|NCT03616990|Behavioral|APN Appointment|Individuals at the SRC will be able to meet with an Advanced Practice Nurse. As part of that visit, the APN will be able to prescribe medications or reroute prescriptions previously administered by the Cook County Jail's hospital, Cermak, to a participant's desired location as needed.
15904177|NCT03616977|Drug|LY900014 U-200|Administered SC
15904178|NCT03616977|Drug|LY900014 U-100|Administered SC
15904181|NCT03616938|Procedure|Cardiopulmonary resuscitation|2-min cycle of cardiopulmonary resuscitation accorind to the American Heart Association 2015 guidelines
15904301|NCT03615989|Dietary Supplement|Skim Milk|500 ml immediately after exercise bout. 500 ml 1 hour after exercise bout.
15904182|NCT03616925|Biological|Platelet Rich Fibrin Matrix kit|Platelet Rich Fibrin Matrix kit was used to procure platelet rich fibrin matrix using centrifugation machine
15904183|NCT03616925|Procedure|surgical open flap debridement|only surgical open flap debridement was done without use of Platelet Rich Fibrin Matrix kit
15904186|NCT03616899|Drug|KPI-121 Ophthalmic Suspension|KPI-121 Ophthalmic Suspension
15904187|NCT03616899|Drug|Vehicle|Vehicle for KPI-121 0.25% ophthalmic suspension
15904188|NCT03616886|Drug|Paclitaxel|Patients will be randomized between chemotherapy (paclitaxel and carboplatin) with immunotherapy including durvalumab with or without oleclumab (1:1 ratio).
15904189|NCT03616886|Drug|Carboplatin|Patients will be randomized between chemotherapy (paclitaxel and carboplatin) with immunotherapy including durvalumab with or without oleclumab (1:1 ratio).
15904190|NCT03616886|Drug|MEDI4736|Patients will be randomized between chemotherapy (paclitaxel and carboplatin) with immunotherapy including durvalumab with or without oleclumab (1:1 ratio).
15904191|NCT03616886|Drug|MEDI9447|Patients will be randomized between chemotherapy (paclitaxel and carboplatin) with immunotherapy including durvalumab with or without oleclumab (1:1 ratio).
15904192|NCT03616873|Other|Early Mobilization|The EM program consists of a progression of functional activities from level of function (LOF) 0 (lowest mobility) to 5 (highest mobility). Each LOF has 3 primary activities designed to promote the patient to the next level. The nurse will begin with mobility activities based on the LOF that matches the patient's current status. The nurse and clinical partner will attempt and/or complete each LOF activity once per shift.
15904193|NCT03616860|Device|Focused Ultrasound (FUS) BBB Disruption|FUS BBB disruption involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct body targets
15904194|NCT03616847|Other|Standard care|Hallux valgus/hallux rigidus surgery with the calf tourniquet remaining in situ until the wound is closed.
15904195|NCT03616847|Other|Tourniquet release|Hallux valgus/hallux rigidus surgery with the calf tourniquet released five minutes before the wound is closed.
15904196|NCT03616834|Drug|Tomivosertib (eFT-508)|Tomivosertib (eFT-508) is a novel, small-molecule investigational drug being developed by eFFECTOR Therapeutics, as an antitumor therapy that acts by selectively inhibiting mitogen-activated protein kinase (MAPK)-interacting serine/threonine kinase (MNK)1 and MNK 2.
15904199|NCT03616808|Other|Thromboelastometry-guided haemostatic treatment|Administration of blood products and/or procoagulants is based on thromboelastometric assays.
15904200|NCT03616795|Drug|LY3154207|Administered orally
15904201|NCT03616795|Drug|[14C]-LY3154207|Administered orally
15904202|NCT03616782|Drug|Ixazomib|Ixazomib 3mg on day 1, 8, 15 q 4 weeks for 24 months or until progression
15904203|NCT03616769|Drug|antiplatelet drugs ,statins ,antihypertensive drugs|According to the international guidelines, we treated patients who suffered from different disease.
15904204|NCT03616756|Behavioral|Authentic Connections|Authentic Connections support groups for nurse leaders who are also mothers. Meetings occur once a week for one hour.
15904205|NCT03616756|Behavioral|Protected time|Participants have one hour per week protected time scheduled on their calendar to do with what they choose.
15904206|NCT03616743|Behavioral|Psychoeducation|Psychoeducation about the links between smoking and chronic pain.
15904207|NCT03616743|Behavioral|Brief smoking control arm|Psychoeducation about the general adverse effects of smoking.
15904209|NCT03616717|Drug|Modafinil|"Drug: modafinil Each participant receives a single pill of placebo or active drug (modafinil 100 mg or 200 mg) 30 minutes after arriving at the lab. The participant then completes approximately 6 hours of testing in the laboratory. The participant stays at the lab for 7.5 hours in order to monitor physical condition in case the participant received the active pill. One week later, that participant receives a single pill of an alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and two active pills, each time separated by one week.
~Other Names:
~Provigil Alertec Modavigil"
15904210|NCT03616717|Drug|placebo|Drug: Placebo Each participant receives a single pill of placebo or active drug (modafinil 100 mg or 200 mg) 30 minutes after arriving at the lab. The participant then completes approximately 6 hours of testing in the laboratory. The participant stays at the lab for 7.5 hours in order to monitor physical condition in case the participant received the active pill. One week later, that participant receives a single pill of an alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and two active pills, each time separated by one week.
15904211|NCT03616691|Drug|Atezolizumab|Stage I: The dose level of atezolizumab proposed to be tested in this study is 1200 mg administered by IV infusion every 3 weeks (q3w)
15904212|NCT03616691|Drug|Bevacizumab|Stage II: Once radiologic progression confirmed from atezolizumab monotherapy (stage 1), 1200mg of atezolizumab would be administered with 15mg/kg of bevacizumab as combination therapy every 3 weeks.
15904250|NCT03616444|Drug|Xiaoai Jiedu Decoction|"The experimental group took Xiaoai Jiedu Decoction twice a day, 28 days for each course of treatment, 2 days rest, followed by the second course of treatment, 3 consecutive courses of treatment in every year， last two years.
~The control group took placebo twice a day, 28 days for each course of treatment, 2 days rest, followed by the second course of treatment, 3 consecutive courses of treatment in every year，last two years."
15904328|NCT03615807|Behavioral|Patient's education and instructions|Patient's education and instructions by specialized nurses
15904213|NCT03616678|Device|VenTouch System|"The VenTouch™ System consists of a delivery tool with a pre-loaded implant (VenTouch device) and accessories, which include a sizing tool, PEMS, chamber positioning tool, and accessories kit with luer fitting, tubing clamp, and titanium plug. The VenTouch device is offered in 6 sizes, with 4 different sized inflatable chambers available. Please refer to the VenTouch Instructions for Use for and system details.
~The VenTouch device consists of three (3) inflatable silicone chambers attached to the wall of a knitted polyester support. The VenTouch device is implanted around the base of the heart and positioned at the level of the atrio-ventricular (AV) groove and the adjacent ventricular muscle. The VenTouch device is composed of biocompatible, medical-grade silicone and polyester."
15904214|NCT03616665|Other|CBASPersonalized|"In addition to CBASPersonalized patients will receive algorithm-based pharmacotherapy in compliance with current national and international guidelines for depression treatment and according to clinical expert supervision. Of note, the intake of the medication is documented and taken into account in the analyses.
~After completion of the six-week inpatient treatment, patients will be offered the six-to-twelve-week blended-online-aftercare CBASPersonalized@home.
~Patients are allowed to attend additional inpatient groups like creative and sports therapy. The participation in these groups is documented."
15904215|NCT03616652|Drug|Placebo|Placebo pill
15904216|NCT03616652|Other|Film sequence|The experimental group watches a film about the power of placebo effects.
15904217|NCT03616652|Other|Film sequence|The control group watches a film about sleep.
15904218|NCT03616639|Drug|Oxycodone|Both continuous administration by a syringe driver as well as bolus administration every 4 hours will be regarded as continuous subcutaneous infusion (CSCI). Dosage and dosage modifications are in accordance with the Dutch national guideline.
15904219|NCT03616639|Drug|Morphine|Both continuous administration by a syringe driver as well as bolus administration every 4 hours will be regarded as continuous subcutaneous infusion (CSCI). Dosage and dosage modifications are in accordance with the Dutch national guideline.
15904220|NCT03616626|Radiation|Once Daily APBI|Adjuvant 3D Conformal Accelerated Partial Breast Irradiation to a dose of 38.5 Gy in 10 once daily fractions given over 2 weeks
15904221|NCT03616626|Radiation|Twice Daily APBI|Adjuvant 3D Conformal Accelerated Partial Breast Irradiation to a dose of 38.5 Gy in 10 twice daily fractions given over 1 week
15904222|NCT03616626|Radiation|Whole Breast Irradiation|Adjuvant 3D Conformal Radiation Therapy to a dose of 50 Gy in 25 fractions over 5 weeks. Boost is given as 10 Gy in 5 fractions over one week to patients with high grade tumors or age younger than 50 years
15904223|NCT03616613|Diagnostic Test|ABDOMINAL DUPLEX ULTRASONOGRAPHY|Abdominal ultrasonography performed by both primary care doctors or vascular surgeons in Hospital de la Santa Creu i Sant Pau area
15904224|NCT03616600|Other|Breath-O-Correct Lens|Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material
15904235|NCT03616574|Drug|CA102N|CA102N is a covalently bound conjugate of the biological polymer sodium hyaluronate (NaHA) and nimesulide (Nim).
15904236|NCT03616574|Drug|LONSURF|LONSURF is a cytotoxic combination treatment of 2 new drugs: trifluridine, a thymidine-based nucleoside analog, and tipiracil, an inhibitor of thymidine phosphorylase.
15904237|NCT03616561|Drug|Apremilast|Target nail ultrasound will be performed in patients on apremilast by two expert dermatologists and each one will determine the ecographic parameters described in the protocol. These variables would be measured in one target nail in each patient, the greatest and most severely affected, at the investigator's criterion. The same nail will be assessed in all visits of the study (baseline, weeks 4, 16, 24, 38 and 52) . The ultrasound study will be performed with the same device in both hospitals: Esaote's MyLab ultrasound with a 20 MHz transducer. Prior to the start of the study the investigators evaluated the ultrasonographic inter-intraobserver concordance.
15904238|NCT03616548|Diagnostic Test|Endoscopic surveillance|Magnifying endoscopy under narrow band imaging system via chimney ileostomy after intestinal transplantation
15904239|NCT03616535|Other|Cognitive training|The investigators will provide participants with tablets to play brain games.
15904240|NCT03616535|Other|Exercise training|The investigators will provide participants with foot peddlers.
15904241|NCT03616535|Other|Combined cognitive and exercise training|The investigators will provide participants with tablets to play brain games for cognitive training and stationary foot peddlers for exercise training.
15904242|NCT03616522|Other|a novel mobile phone-based intervention for automated electronic PRO collection|Over the three-month study period, patients will be prompted weekly via text message to self-report up to eleven common symptoms, as well as their performance status and quality of life.
15904243|NCT03616509|Drug|Growth hormone|12 months on Growth hormone, initial dose 0,2 mg per day, then adjusted by insulin like growth factor (IGF-1) level
15904244|NCT03616509|Drug|Placebo|2 months on placebo, sodium chloride 0,9% injections
15904245|NCT03616496|Drug|Neuraceq PET/CT imaging|PET/CT with Neuraceq injection, blood and urine sampling for protein electrophoresis, bone scintigraphy for the three arm (if the exams are present in the patient's medical record and are less than 3 months old, they do not need to be repeated
15904246|NCT03616483|Other|This is a non-interventional trial|This is a non-interventional trial
15904247|NCT03616470|Drug|Uproleselan|A rationally designed E-selectin antagonist used to inhibit binding of cells to E-selectin
15904248|NCT03616470|Drug|Placebo|Saline, 0.9% Sodium Chloride
15904251|NCT03616431|Diagnostic Test|Pancreo-KIT breath test|"Pancreo-Kit (Isomed Pharma, Madrid, Spain) is a breath test devised to measure Pancreatic Enzyme Insufficiency. It is a non-invasive method to obtain information about the digestion of consumed lipids; this in turn is informative about the exocrine enzyme activity of the pancreas (specifically pancreatic lipase). This kit is manufactured to EC directive 98/79/EEC and carries the CE mark.
~The test is based on measurement of 13C which is a stable naturally occurring environmental isotope of carbon with a nucleus containing 6 protons and 7 neutrons (note, it is not radioactive)."
15904252|NCT03616418|Drug|antiplatelet drugs;statins;antihypertensive drugs|
15904253|NCT03616405|Drug|rabeprazole, amoxicillin, tetracycline, furazolidone (only for the first 7 days), colloidal bismuth pectin (for the second 7 days)|Patients will go through a gastroscopy and antimicrobial susceptibility test. Liver and kidney function will be monitored by blood test before and after the treatment. Then, patients will receive a 14-day modified sequential therapy for the Helicobacter pylori eradication. The regimen contains rabeprazole, amoxicillin, tetracycline and furazolidone for the first 7 days, followed by rabeprazole，amoxicillin, tetracycline and colloidal bismuth pectin for the second 7 days.
15904254|NCT03616392|Drug|D308, CKD-501|"D308
~CKD-501: Lobeglitazone sulfate 0.5mg"
15904255|NCT03616379|Behavioral|Psychoeducational Control|The Psychoeducational Control condition will consist of a brief script describing the body's response to stress and will not discuss cognition or the role of interpretation or affect labeling during stress.
15904256|NCT03616379|Behavioral|Affect Regulation|In the Affect Regulation Condition, participants will be provided instructions for how to reappraise negative thoughts in the context of stress by developing statements consistent with more benign interpretations of stress (e.g., This won't last forever.).
15904257|NCT03616379|Behavioral|Affect Labelling|In the Affect Labeling Condition, participants will be provided with instructions for how to verbalize their emotional response during the stressor.
15904258|NCT03616353|Procedure|Perineural Hydrodissection|The subcutaneous tissues of the ulnar aspect of the wrist at the level of the carpal tunnel will be infiltrated with 2 ml of lidocaine 1% for local anesthetic. Using ultrasound guidance and aseptic technique, the needle will then be angled deep to the median nerve within the carpal tunnel, and 5 ml of a 50%/50% mixture of lidocaine 1% and sensorcaine 0.5% will be injected under pressure. While continuing to use ultrasound guidance and aseptic technique, the needle will then be angled superficial to the median nerve within the carpal tunnel, and 5 ml of a 50%/50% mixture of lidocaine 1% and sensorcaine 0.5% will be injected under pressure. The needle will be returned to its original angle deep to the median nerve, and the syringe will be changed to inject 40 mg Depo-Medrol in 1ml of saline.
15904259|NCT03616353|Procedure|Corticosteroid Injection|The subcutaneous soft tissues of the ulnar aspect of the wrist at the level of the carpal tunnel will be infiltrated with 2 ml of lidocaine 1% for local anesthetic. Using ultrasound guidance and aseptic technique, the needle will then be angled deep to the median nerve within the carpal tunnel, and 40 mg Depo-Medrol in 1ml of saline will be injected into the area deep to the median nerve.
15904260|NCT03616340|Drug|Shoulder injection|intra articular or subacromial shoulder injection
15904261|NCT03616340|Drug|knee injection|intra-articular knee injection
15904262|NCT03616327|Device|MATRx in-lab, MATRx plus|The MATRx remotely controlled mandibular positioner (RCMP) consists of temporary dental trays connected to an extra-oral linear actuator that protrudes the mandible. MATRx is used during polysomnography, where sleep and cardio-respiratory variables are recorded during sleep. The position of the mandible is controlled remotely by a sleep technologist, who moves the mandible while monitoring cardio-respiratory variables. The test determines if mandibular protrusion eliminates pharyngeal obstruction and the required protrusion. The MATRx plus is used in the home. Like the RCMP, the patient sleeps with the motorized mandibular positioner (MP) in place. However, the MP's position is controlled by a computer, making it a feedback controlled mandibular positioner (FCMP). The FCMP detects apneas and hypopneas in real time. Using this information, the controller decides when to move the mandible and by how much. The test predicts of therapeutic outcome with OA and provides a target protrusion.
15904263|NCT03616314|Device|stepping verticalization plus functional electrical stimulation|patients hospitalized in ICU are rehabilitated using 30 minutes/day of conventional physiotherapy + 30 minutes/day of verticalization using a tilt table with an integrated robotic stepping device synchronized with an electrical stimulation of the lower limbs muscles
15904264|NCT03616314|Device|stepping verticalization|patients receive 30 minutes/day of conventional physiotherapy + 30 minutes7day of verticalization using a tilt table with a robotic stepping device
15904265|NCT03616314|Other|conventional physiotherapy|patients are treated only with 60 minutes/day of conventional physiotherapy
15904266|NCT03616301|Drug|Clavamox|Clavamox, Powder for Oral Suspension, 400 mg + 57 mg / 5 ml, manufactured by Pharmtechnology LLC, Belarus
15904267|NCT03616301|Drug|Augmentin®|Augmentin®, Powder for Oral Suspension, 400 mg + 57 mg / 5 ml, marketed by CJSC GlaxoSmithKline Trading, Russia
15904268|NCT03616288|Dietary Supplement|thiamine (as thiamine hydrochloride)|Opaque capsules containing varying amounts of thiamine hydrochloride and cellulose filler. All thiamine is delivered as thiamine hydrochloride, calculated using a 1.271 correction factor (ratio of molecular weights of thiamine hydrochloride and thiamine).
15904269|NCT03616275|Other|HRV biofeedback|HRV biofeedback protocol is modified from Lehrer's HRV biofeedback manual (2000), which had been successfully used to improve functioning and quality of life for patients with asthma and COPD. A noninvasive biofeedback system with a NeXus-10 with BioTrace+ (Mind Media B.V., Netherlands) and laptop computer will be used for biofeedback intervention. The intervention protocol is including paced breathing in resonant frequency, abdominal breathing and pursed-lip breathing, and visual biofeedback. The designed intervention protocol will include 8 once-a-week, individual, 20-min in hospital training sessions and twice-a-day, 20-min home self-practices.
15904270|NCT03616262|Drug|Botox + Lidocaine|The total dose per patient in the lower extremity or upper extremity will be based on common doses given in spasticity patients in the neurology injection clinic. If the target is a symptomatic arm, we will inject as follows: biceps 30 units, triceps 40 units, flexor carpi radialis 20 units, extensor carpi radialis 20 units. If the target is a symptomatic leg, we will inject in the following pattern: vastus lateralis 50 units, rectus femoris 30 units, medial gastrocnemius 40 units, tibialis anterior 40 units.
15904300|NCT03615989|Dietary Supplement|Carbohydrate (Maltodextrin powder mixed with water)|50 grams immediately after exercise bout. 50 grams 1 hour after exercise bout.
15904271|NCT03616262|Drug|Lidocaine alone|The total dose per patient in the lower extremity or upper extremity will be based on common doses given in spasticity patients in the neurology injection clinic. If the target is a symptomatic arm, we will inject as follows: biceps 30 units, triceps 40 units, flexor carpi radialis 20 units, extensor carpi radialis 20 units. If the target is a symptomatic leg, we will inject in the following pattern: vastus lateralis 50 units, rectus femoris 30 units, medial gastrocnemius 40 units, tibialis anterior 40 units.
15904272|NCT03616249|Other|Sleep|Initially, all volunteers will undergo the following pre and post-intervention tests: Polysomnography; Actigraphy for 10 days; Maximum exercise test; blood collection; Physical performance evaluation; Assessment of muscle strength, assessment of body composition; And application of questionnaires.
15904273|NCT03616249|Other|Resistance Exercise|After these procedures, the sarcophagic elderly will Resistance training, will be performed according to the latest positioning of the American College of Sports Medicine for the training of the elderly . The training will last 12 weeks, 3 times / week, with intervals of 48h between the training sessions, which will have a maximum duration of 60min. The periodization of the training will be done in a linear way, in which the volunteers will be submitted to training with 1 series of 12 to 15 repetitions at 60% of 1RM in the first week; In the second week volunteers will train at 70% of 1RM, performing 2 sets of 10 to 12 repetitions; And from the third week to the end of the training period the volunteers will train at 80% of 1RM performing 3 sets of at most 8 replicates and the intervals between sets may range from 60min to 180min. The training load will be readjusted in the 6th week of training from a new 1RM test and the training will be on the same test equipment.
15904274|NCT03616236|Drug|Buprenorphine/Naloxone|Participants will begin buprenorphine pharmacotherapy using the MedicaSafe buprenorphine dispensing device immediately after an on-site intake at a community supervision office and continue such treatment until they are transitioned to community buprenorphine treatment
15904275|NCT03616236|Other|Treatment as usual|Participants will receive a referral to buprenorphine treatment in the community
15904276|NCT03616223|Drug|FX-322|Cohort of 8 subjects
15904277|NCT03616223|Drug|Placebo|2 Cohorts of 4 subjects each
15904278|NCT03616210|Procedure|Protective ventilation|Protective ventilation strategy with tidal volume of 6 to 7 ml.kg-1 of predicted body weight and PEEP of 6 to 8 cmH2O.
15904279|NCT03616197|Procedure|free gingival graft|A horizontal incision was made along the mucogingival line with a scalpel number 15 to prepare a bed of periosteum and a thin immobilized connective tissue. The moving gingival tissues were removed coronally, and the bed was prepared so that the immobilized keratinized gingival tissue was preserved and the graft was placed apically. The template of the recipient region was placed in the donor region to be 2-3 mm more apically than the gingival margins of the teeth. The number of 15 scalpel was used to make incision at the template border and perpendicular to the keratinized tissue. The graft thickness was standardized in all patients between 1.5-2 mm. FGG was placed over the recipient bed and 5/0 non-resorbable monofilament sutures were used for fixing the four corners of the graft.
15904280|NCT03616184|Drug|Ruxolitinib|Patients with sclerotic chronic graft-versus-host disease (GVHD) will receive oral ruxolitinib at a dose of 10 mg twice daily. Doses may not exceed 10 mg twice daily. Ruxolitinib will be continued for 6 months. Patients who continue to have stable disease, mixed responses or partial/complete responses at the end of 6 months may continue the drug for a total of 12 months.
15904281|NCT03616171|Behavioral|SLEEP-Extend intervention|"One education session (5-10 minutes) consisting of strategies for sleep hygiene which is the routine for going to sleep
~Instructions on extending time in bed by at least one hour but can be up to 2 hours total per night for 4 weeks which can be accomplished by either going to bed earlier or staying in bed later"
15904282|NCT03616171|Other|Control|Control group will receive 1. One educational session (5-10 minutes) consisting of safety practices used for an urban environment (a safety brochure and safety information will be given and reviewed with the subject)
15904283|NCT03616145|Procedure|Osteopathic Manipulative Treatment (OMT)|Experimental Condition
15904284|NCT03616145|Other|Light Touch|Comparator Arm
15904285|NCT03616132|Device|Device: Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System|Implantation of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System (IBS)
15904286|NCT03616106|Other|Infographic intervention|All study participants will receive health education using infographics during their regularly scheduled clinic appointments.
15904287|NCT03616093|Other|Test Beet Shot|Active supplement containing 6.2 mmol nitrate
15904288|NCT03616093|Other|Placebo Beverage|Placebo supplement containing negligible nitrate
15904289|NCT03616080|Behavioral|soccer play program|once a week for an hour of a soccer program for 8 weeks
15904290|NCT03616067|Drug|Botox® injection|Botox® injection in salivary glands will be performed one month after inclusion. It will be performed with one injection point per gland (parotids and submandibulars)
15904291|NCT03616067|Drug|Scopoderm® patches arm|Scopoderm® patches will be initiated one month after inclusion. The patches will be renewed every 3 days, alternating behind each ear.
15904292|NCT03616041|Device|Second-generation colon capsule endoscopy system|The PillCam (TM) Colon 2 which is a second-generation colon capsule endoscopy system, developed by Medtronic Inc. Colon capsule endoscopy, in contrast to current generation small bowel capsules, is capable of visualizing the entire lumen and mucosa from esophagus to rectum. This can be crucial for patients being screened or evaluated for colon disorders. This new generation of colon capsule endoscopy has a battery life of at least 10 hours and preserves energy using adaptive frame rate technology.
15904293|NCT03616028|Device|left atrial appendage closure|Closure of the left atrial appendage (LAAC) is performed percutaneously. Implantation of the CLAAS device will be performed according to device specific instructions for use based on both TEE guidance, ICE and angiography, femoral access and inter-atrial septum crossing
15904294|NCT03616015|Biological|blood samples|20 to 30 ml of blood sample (D0, D15, D30, D60, D90, D180, Y1, Y2)
15904295|NCT03616015|Biological|fecal samples|1 g of feces (D-8, D0, D15, D30, D90)
15904296|NCT03616015|Behavioral|Anxiety test|Test of Spielberger
15904297|NCT03616015|Behavioral|Stress test|Test of Cohen
15904298|NCT03616002|Other|Hookah smoking|ad lib hookah smoking for 30 minutes in a controlled laboratory environment.
15904299|NCT03615989|Behavioral|Resistance and Plyometric Exercise|A single resistance and plyometric exercise bout per trial.
15928440|NCT03431610|Drug|SB414 2%|Twice daily
15904302|NCT03615976|Procedure|high tibial osteotomy with or without arthroscopic circumpatellar denervation with or without arthroscopic circumpatellar denervation|"Arthroscopy will be done in all cases before osteotomy to assess lat. Comp and grade of patellofemoral O.A Arthroscopic patellar denervation with vaper or diathermy will be done plus open wedge high tibial osteotomy in one group and other group OWHTO only will be done comparing the rustles of two groups to assess the efficacy of this procedure
~followed by an average follow up to 12 months. And follow up( 6th weeks ,3rd month ,6th month , 12th month)
~By clinical examinationan and x-ray and knee scores
~Scoring of patellofemoral disorders( Kujala) score
~Knee Injury and Osteoarthritis Outcome Score (KOOS)"
15904303|NCT03615963|Diagnostic Test|echocardiography and coronary angiography|transthoracic echocardiography will be done for all subjects to measure aortic stiffness and elaticity then coronary angiography was used to differentiate between normal subjects and who have coronary artery disease
15904304|NCT03615950|Diagnostic Test|Bone Mineral Density (DEXA) scan|Radiologic assessment of bone mineral density in the lumbar spine. This will be performed at screening. If abnormal at screening, subjects will not be enrolled. For enrolled subjects, DEXA will be repeated at 12 months.
15904305|NCT03615950|Diagnostic Test|Vitamin D Measurement|Measurement of 25-hydroxy vitamin D levels through the blood at baseline and 12 months. If low for age, subjects will receive dietary counseling to increase intake to recommended levels. Primary care providers of enrolled subjects will be notified of abnormal results.
15904306|NCT03615950|Diagnostic Test|Height measurement|Height will be measured at baseline and 12 months.
15904307|NCT03615950|Other|Assessment of medication compliance|Subjects enrolled in the intervention group will undergo assessment of compliance with swallowed corticosteroids prescribed by their clinical provider. This will be performed at 6 and 12 months.
15904308|NCT03615937|Behavioral|Child interactive intervention|The Child Interactive Intervention will be delivered through a Dialogic Reading Program, which is an individual/group level intervention component for both families and kindergartens. The original Dialogic Reading Program aims to enhance children's literacy and oral language skills by using the specific technique of shared book reading developed by Whitehurst and colleagues (1988). However, this project will expand from the original Dialogic Reading Program template to include alignment with local kindergarten curriculum and themed interactive activities that help build social competence and emotional maturity in children, in addition to cognitive skills.
15904309|NCT03615937|Behavioral|Family Empowerment|Family empowerment in this project can be conceptualized across three main pillars: 1) adaptive parenting; 2) adaptive extended family environment; and 3) familial resources. Typically, adaptive parenting is translated into positive parenting programs for primary caregivers, and the rest of the family environment involves extended caregivers. However, families from disadvantaged environments encounter many hurdles that hinder effective parenting and relationship nurturing, and parents' mental wellbeing are also consistently impacted by competing demands.
15904310|NCT03615937|Behavioral|Access to Community Hub and its services|A new model of Community Hub will be implemented and there will be two hubs established in two respective districts. The Community Hubs act as an alternative venue to implement service delivery of intervention packages, such as activity sessions in the Child Interactive Intervention, Parenting Program, and mentor-mentee experience exchange, which provide families institutional flexibility and extended support while internalizing new practices. There will also be health education, consultation support and developmental assessments. The Hubs will play the roles of promoting and interweaving play-based learning into the lives of families frequently faced with competing demands and a lack of resources, and enable a protracted network for parents.
15904311|NCT03615937|Other|Enhancement to the kindergartens|This intervention package aims at providing a better physical and social kindergarten environment to maximize developmental reach and expedite timely interception and feedback without adding burden to teachers and frontline service professionals.
15904312|NCT03615937|Other|Health education, screening, and support|Health seminars and interactive workshop will be provided to the families. Screen for common child health problems (e.g. dental and visual) will also be conducted. A support hotline and website will be established for the participants.
15904313|NCT03615924|Drug|Ticagrelor|"The double-blinded study drug dose will be weight dependent:
~≥12 to ≤24kg: Ticagrelor 15 mg, twice a day
~>24 to ≤48 kg: Ticagrelor 30 mg, twice a day
~>48 kg: Ticagrelor 45 mg, twice a day."
15904314|NCT03615924|Drug|Placebo|"The double-blinded study drug dose will be weight dependent:
~≥12 to ≤24kg: Placebo to match ticagrelor 15 mg, twice a day
~>24 to ≤48 kg: Placebo to match ticagrelor 30 mg, twice a day
~>48 kg: Placebo to match ticagrelor 45 mg, twice a day."
15904315|NCT03615911|Biological|vaccine candidate MVA-MERS-S|vaccination with MVA-MERS-S in two escalating dose regimes
15904316|NCT03615898|Other|Medication errors analysis|TEN YEAR ANALYSIS OF MEDICATION ERRORS IN THE SPANISH INCIDENTS REPORTING SYSTEM IN ANAESTHESIA
15904317|NCT03615885|Dietary Supplement|Montmorency Tart Cherry Capsules|Capsules are made from 100% natural, tart Montmorency cherries. Carefully prepared Montmorency cherry skins are freeze-dried and milled into a fine powder to protect the cherry phytonutrients and optimise absorbtion. This powder is then encapsulated into a 100% vegetarian shell.
15904318|NCT03615885|Dietary Supplement|Montmorency Tart Cherry Juice|"100% natural, tart Montmorency cherry concentrate (30mL) diluted with 100mL water.
~Concentrate contains no sweeteners, preservatives, flavourings or added sugar."
15904319|NCT03615885|Dietary Supplement|Placebo|"130ml serving
~Placebo composition: Water (100ml), Cherry Cordial Concentrate (30ml), Citric Acid (1.5g), Maltodextrin (24.75g), Black Food Colouring (2ml)."
15904320|NCT03615872|Device|pessary use|evaluation of satisfaction of pessary use in case of symptomatic genital prolapse
15904321|NCT03615833|Drug|Cholecalciferol|Cholecalciferol 2.5mg (100 000 UI) , once a month for 3 months
15904322|NCT03615820|Drug|Niosomal PPE oromucoadhesive film|Niosomal PPE oromucoadhesive film in which Propolis entrapped in niosomal vesicles and incorporated in oromucoadhesive film
15904323|NCT03615820|Drug|Oromucoadhesive film|Oromucoadhesive film without PPE control testing which represents Placebo group
15904324|NCT03615807|Procedure|Surgical debridement (if needed)|Surgical debridement
15904325|NCT03615807|Diagnostic Test|Microbiological sampling|Microbiological sampling
15904326|NCT03615807|Procedure|Revascularisation (if needed).|Revascularisation (if needed).
15904327|NCT03615807|Device|Off-loading|Off-loading by Special shoes
15928441|NCT03431610|Drug|SB414 6%|Twice daily
15904329|NCT03615807|Procedure|Wound debridement|Regular wound debridement by specialized nurses
15904330|NCT03615807|Drug|Antibiotic duration|Systemic antibiotic duration according to the study arms
15904331|NCT03615781|Procedure|Two week's arm - surgery|The investigators perform a surgical drainage of the infection along with the complete removal of the infected orthopedic implant.
15904332|NCT03615781|Procedure|Four week's arm - surgery|The investigators perform a surgical drainage of the infection along with the complete removal of the infected orthopedic implant.
15904333|NCT03615781|Drug|Two week's arm - drugs|After the surgical implant removal, the investigators prescribe a total of 2 weeks of systemic targeted antibiotic therapy against the causative pathogen(s), of which one week is recommended to be intravenously.
15904334|NCT03615781|Drug|Four week's arm - drugs|After the surgical implant removal, the investigators prescribe a total of 4 weeks of systemic targeted antibiotic therapy against the causative pathogen(s), of which one week is recommended to be intravenously.
15904335|NCT03615768|Combination Product|Adapalene-Clindamycin Combination Gel|5mg Adapalene/50mg Clindamycin per 5g, applied nightly for 12 weeks
15904336|NCT03615768|Drug|Adapalene Gel|Differin 0.1% Gel, applied nightly for 12 weeks
15904337|NCT03615768|Drug|Clindamycin Gel|Clindamycin Phosphate 1% Gel applied twice daily for 12 weeks
15904338|NCT03615755|Other|Hyperbaric Oxygen Therapy (HBOT)|The investigators used 10 sessions of HBOT. One session of HBOT uses oxygen at 2.4 ATA for 90 minutes per day at multiplace hyperbaric chamber. This therapy is given five sessions in a week, so it takes two weeks.
15904339|NCT03615742|Other|Placebo|Inhalation of air through a Turbuhaler that contains no medication, as a control.
15904340|NCT03615742|Drug|Budesonide|1.6mg of budesonide from a Turbuhaler.
15904341|NCT03615742|Other|Filtered Air|Exposure to HEPA filtered air, as a control.
15904342|NCT03615742|Other|Diesel Exhaust|Diesel exhaust standardized to 300µg/m³ of particulate matter with a diameter of 2.5 micrometers or less (PM2.5).
15904343|NCT03615716|Behavioral|Multi-level Violence Prevention Intervention - Boys|Comprehensive, Multi-level Violence Prevention Intervention. The intervention consists of three components: (1) a 15-week after-school program, (2) group mentoring, and (3) community enhancement activities. Adolescents and mentors will attend a 2-hour weekly session at a community center, and will conduct up to four community enhancement activities. At the end of the program, a graduation celebration will be planned, and parents/guardians and stakeholders (e.g., coalition members) will be invited.
15904344|NCT03615716|Behavioral|Multi-level Violence Prevention Intervention - Caregivers|This is arm is measuring the Multi-level Violence Prevention Intervention that is administered to the boys, from the perspectives of their caregivers. The caregivers themselves will not receive an intervention, but their perspectives of the impact on the interventions on the boys will be examined
15904345|NCT03615690|Other|Fasting Mimicking Diet|5 day reduced calorie diet
15904346|NCT03615690|Other|Regular Diet|Regular Diet
15904347|NCT03615677|Drug|LXI-15028 50mg|The investigational products are administrated orally, once in the morning every day, and each dose includes 2 tablets of investigational products (LXI-15028 50mg active agent + Esomeprazole 40mg matching placebo . If the investigational product is not taken in the morning, subjects can take it before 6:00 p.m. on the same day. The duration of treatment is 4 or 8 weeks.
15904348|NCT03615677|Drug|Esomeprazole 40mg|The investigational products are administrated orally, once in the morning every day, and each dose includes 2 tablets of investigational products ( LXI-15028 50mg matching placebo + Esomeprazole 40mg active agent ). If the investigational product is not taken in the morning, subjects can take it before 6:00 p.m. on the same day. The duration of treatment is 4 or 8 weeks.
15904349|NCT03615664|Drug|Bendamustine|Bendamustine (B) 90 mg/m2 i.v. day 1, 2
15904350|NCT03615664|Drug|Gemcitabine|Gemcitabine (G) 800 mg/m2 i.v. day 1, 4
15904351|NCT03615664|Drug|Dexamethasone|Dexamethasone (D) 40 mg i.v./p.o. day 1,2,3,4
15904352|NCT03615664|Diagnostic Test|PET/CT|"PET scan/CT must be performed after first 2 courses of BGD treatment. Results evaluation:
~in case of a CMR/CR or PMR/PR, ASCT must be performed within 3 months after the end of BGD treatment
~in case of SMD - exclusion from the trial
~in case of PMD - exclusion from the trial"
15904353|NCT03615664|Procedure|Autologous Stem Cell Transplant|"Must be performed within 3 months after the end of BGD treatment.
~When it is not possible to perform ASCT, despite CMR or PMR response, within 3 months after second course of BGD treatment, it is permissible to extend the therapy up to 4 cycles. PET scan/CT must be repeated before performing ASCT."
15904354|NCT03615651|Dietary Supplement|Probiotic|The Probiotic Formula is commercially available and contains a combination of 3 probiotic strains in addition to other nutrients. The total daily amount of probiotic strain in the product will be no less than 3 billion colony-forming units (CFU) per 3 g powder sachet.
15904355|NCT03615651|Other|Placebo|Placebo intervention.
15904356|NCT03615638|Other|Fall prevention program|12-week fall prevention program (including warm-up, cool-down, education, Tai Chi, and lower limb strengthening)
15904357|NCT03615625|Behavioral|Power Training Session|"3 sets of 8-10 repetitions of 5 exercises performed in the following order: leg press, bench press, knee extension, upright row, and knee flexion, using an intensity corresponding to 50 % of 1-RM and two-minute intervals between sets and exercises. The concentric phase of exercises during each repetition was performed as fast as possible while the eccentric phase lasted 1-2 seconds."
15904358|NCT03615612|Other|QuickSee refractive error assessment + glasses|QuickSee refractive error assessment + glasses
15904359|NCT03615586|Other|With Chaperone|Female patients examined by male physicians in the presence of a female (nurse) chaperone.
15904360|NCT03615586|Other|Without Chaperone|Female patients examined by male physicians without the presence of a female (nurse) chaperone.
15904361|NCT03615573|Other|Quality of Life Surveys|Patients with breast cancer diagnosis complete questionnaires over 20-30 minutes at baseline and at 3, 6, and 12 months after enrollment.
15904393|NCT03615352|Procedure|ovarian cyst aspiration and coagulation|laparoscopic ovarian cyst aspiration and coagulation in endometrioma
15904394|NCT03615339|Dietary Supplement|Molkosan|Twice daily (AM and PM) 20ml of fermented whey concentrate consumed diluted in 200ml water
15904395|NCT03615326|Biological|Pembrolizumab|200 mg on Day 1 of each 3-week cycle as an IV infusion.
15904396|NCT03615326|Biological|Placebo|Solution for IV infusion on Day 1 of each 3-week cycle.
15904362|NCT03615547|Drug|Clomifene Citrate|"After randomization, the andrologist will give a prescription with the first three months of treatment (Clomifene Citrate or placebo) to be collected to the local hospital pharmacy. The andrologist will be blind of the treatment arm.
~Treatment unit and their shipment to local pharmacy will be provided and organized by the East group pharmacy of the Hospices Civils of Lyon which is the coordination pharmacy for this study. Prescription and delivery will be renewed for three months at the 3 month and 6 months visit.
~The experimental treatment consists in a daily dose of 50mg of Clomifene Citrate per os during 9 months followed by a second TESE if no spermatozoid has been obtained from semen. The dose level was set according to Chua et al 2013 (cf 1.2.2). One capsule containing 50 mg of CC will be orally administered in the morning every day."
15904363|NCT03615547|Other|Placebo|The placebo treatment consists in a daily dose of 50mg of lactose monohydrate per os during 9 months followed by a second TESE if no spermatozoid has been obtained from semen. The capsule containing the placebo will have the exact same size, weight, color, taste and will be delivered in the exact same condition as the experimental treatment capsule.
15904364|NCT03615534|Other|Therapeutic Lifestyle Changes|Four-week therapeutic lifestyle changes run-in period, comprising individualized moderate physical activity and total calories reduction.
15904365|NCT03615534|Other|Placebo|
15904366|NCT03615534|Drug|Fenofibrate|
15904367|NCT03615534|Dietary Supplement|Wax Matrix Extended Release Niacin (WMER Niacin)|
15904368|NCT03615521|Other|Hotpack|Hotpack applied 20 minutes for knee 3 session for 6 weeks
15904369|NCT03615521|Other|Ultrasound|Ultrasound applied 10 minutes for knee 3 session for 6 weeks
15904370|NCT03615521|Other|Combine Exercise|Proprioceptive Neuromusculer Facilitation Technique İnclude eccentric and concentric contractions 3 session for 6 week
15904371|NCT03615521|Other|Repeated Contraction Exercise|Proprioceptive Neuromusculer Facilitation Technique include concentric contractions 3 session for 6 week
15904372|NCT03615521|Other|Standart Exercise Therapy|"Quadriceps, hamstring and hip muscle strength exercise. Hamstring stretch exercise.
~3 session for 6 week"
15904373|NCT03615508|Drug|10% phenylephrine|10% phenylephrine is a drug that can be used to dilate patient's eyes at their yearly eye examination. All enrolled subjects will receive this drug for their eye dilation.
15904374|NCT03615495|Device|Flourish Pediatric Esphogeal Atresia device|The Flourish Pediatric Esophageal Atresia device consists of an esophageal catheter and a gastric catheter. Both catheters are equipped with an inner magnet catheter. When the esophageal and gastric catheters are aligned tip to tip, the magnets attract.
15904375|NCT03615482|Biological|V114|Single 0.5 mL injection
15904376|NCT03615482|Biological|QIV|Single 0.5 mL injection
15904377|NCT03615482|Biological|Matching Placebo for V114|Single 0.5 mL injection
15904378|NCT03615469|Device|Transcutaneous electrical stimulation|For the Sham group, electrodes will follow the same landmarks, but the stimulation will only increase to an intermittent tingling sensation with the machine setting on TENS instead of NMES which is not enough to make noticeable changes in muscle mass or circulation. Intensity settings will not change over time.
15904379|NCT03615469|Device|Neuromuscular electrical stimulation|When applying the stimulation, the intensity will be gradually increased from an intermittent tingling until a gentle pumping sensation is felt and muscle contraction is seen. Participants will direct the amount of stimulation acceptable on both thighs to improve acceptance of the modality.10,24,29-31 To assist better tolerance large electrodes (2x4) will be used and participants will also be instructed to be in a seated position with chair close to the wall so that their leg is 90-degree angle and then push against the wall to decrease any uncomfortable feeling during the contraction. 5 sessions per week for 6 weeks done independently at home, with 15 minutes per session (15 minutes per day/session, 15 seconds stimulation on, 15 seconds recovery time) to both legs. We expect the participant to develop tolerance to the treatment and thus increase the intensity of the NMES over time.
15904380|NCT03615456|Procedure|Conventional thyroidectomy|Thyroid vessels are ligated with sutures and divided
15904381|NCT03615456|Procedure|Harmonic scalpel thyroidectomy|Thyroid vessels are sealed using harmonic scalpel device
15904382|NCT03615443|Diagnostic Test|Guardant360|Guardant360 is a comprehensive, non-invasive tumor sequencing test.
15904383|NCT03615430|Procedure|serratus plane block with local anesthetic|The high-frequency linear array ultrasound transducer (UST) was placed parallel to the cephalocaudal axis of the body in T4 levels on the side of the mid-axillary line, identifying latissimus dorsi and serratus anterior, through the thoracic artery to help to find the serratus anterior and 15 ml 0.25% ropivacaine was administered.
15904384|NCT03615430|Procedure|serratus plane block with saline|The high-frequency linear array ultrasound transducer (UST) was placed parallel to the cephalocaudal axis of the body in T4 levels on the side of the mid-axillary line, identifying latissimus dorsi and serratus anterior, through the thoracic artery to help to find the serratus anterior and 15 ml saline was administered.
15904385|NCT03615417|Device|High Flow Nasal Cannula (HFNC)|"Preoxygenation trough High Flow Nasal Cannula (HFNC) at 100% FiO2, 50 liters/min and closed mouth.
~After Rapid Sequence Induction (RSI), maintenance of apnea with HFNC at 100% FiO2, 70 liters/min and jaw thrust.
~At time of peripheral oxygen saturations (SpO2) decreases by 2% or after 10 minutes of apnea, the participant is intubated."
15904386|NCT03615417|Device|Standard anesthesia FaceMask (FM)|"Preoxygenation trough standard anesthesia FaceMask (FM) at 100% FiO2, 12 liters/min, CPAP 7 cmH2O.
~After Rapid Sequence Induction (RSI), maintenance of apnea without mask. At time of peripheral oxygen saturations (SpO2) decreases by 2% or after 10 minutes of apnea, the participant is intubated."
15904387|NCT03615404|Biological|CMV-DCs with GM-CSF|CMV-DCs are autologous dendritic cells derived from PBMCs loaded with RNA encoding the human CMV matrix protein pp65 as a fusion protein with the full-length LAMP protein (pp65-flLAMP) plus GM-CSF.
15904388|NCT03615404|Biological|Td (tetanus toxoid)|Patients will receive preconditioning with Td in the right groin, and approximately 6-24 hours later, they will receive their first CMV-DC vaccination. Patients will also receive Td preconditioning approximately 6-24 hours prior to their 4th vaccine and subsequent vaccines, if any.
15904389|NCT03615378|Dietary Supplement|5000 IU D3|Daily
15904390|NCT03615378|Dietary Supplement|1000 IU D3|Daily
15904391|NCT03615378|Dietary Supplement|Placebo|lactose/sugar tablet
15904392|NCT03615352|Procedure|ovarian cystectomy|laparoscopic ovarian cystectomy in endometrioma
15904427|NCT03615105|Drug|Cyclophosphamide|Cyclophosphamide 60 mg/kg IV
15904397|NCT03615326|Drug|Cisplatin|80 mg/m^2 on Day 1 of each 3-week cycle as an IV infusion, administered as part of FP chemotherapy regimen.
15904398|NCT03615326|Drug|5-FU|800 mg/m^2/day continuous on Days 1-5 of each 3-week cycle (120 hours or per local standard), administered as part of FP chemotherapy regimen.
15904399|NCT03615326|Drug|Oxaliplatin|130 mg/m^2 on Day 1 of each 3-week cycle over 2 hours as an IV infusion, administered as part of CAPOX chemotherapy regimen and as part of SOX chemotherapy regimen.
15904400|NCT03615326|Drug|Capecitabine|1000 mg/m^2 as oral capsules BID on Days 1-14 of each 3-week cycle, administered as part of CAPOX chemotherapy regimen.
15904401|NCT03615326|Drug|S-1|Combination product of tegafur, CDHP, and Oxo. Oral capsules BID on Days 1-14 of each 3-week cycle based on body surface area (BSA): <1.25 m^2 BSA =40 mg, 1.25 to <1.5 m^2 BSA=50 mg, ≥1.5 m^2 BSA=60 mg. Administered as part of SOX chemotherapy regimen.
15904402|NCT03615326|Biological|Trastuzumab|8 mg/kg loading dose and then 6 mg/kg maintenance dose administered IV on day 1 of each 3-week cycle.
15904403|NCT03615313|Biological|PD-1 antibody expressing mesoCAR-T cells|Patients with mesothelin positive cancer will be infused the PD-1 antibody expressing mesoCAR-T cells. The modified mesoCAR-T cells can specifically kill mesothelin positive cancer cells and secrete PD-1 antibody, which could enhance the cytotoxicity of mesoCAR-T cells and activate the tumor infiltrating lymphocytes.
15904404|NCT03615300|Diagnostic Test|serum NGAL|serum NGAL was measured at 0, 24, 48, and 72 hours after recovery of spontaneous circulation.
15904405|NCT03615274|Device|Executive function training|Home-based executive function training with adaptive difficulty, through Cogmed and Cognifit systems over 6 weeks (30-45 minuts/day, 5 days per week). Cognitive training will consist on working memory training (Cogmed, www.cogmed.com) and executive/inhibitory function training (Cognifit, www.cognifit.com).
15904406|NCT03615274|Other|Psychoeducation|Learning basic healthy habits through daily Prezi presentations that include healthy food recommendations, funny receipts to families, ideas for exercising, emotion and behavioral management strategies, etc.
15904407|NCT03615274|Device|Placebo non-adaptive training|Executive function training with non-adaptive difficulty through Cognifit system over 6 weeks (30-45 minuts/day, 5 days per week). Exercices will be the same as the ones in the experimental group but minimizing the executive/working memory component and without incresing difficulty.
15904408|NCT03615261|Behavioral|Mothers and Babies (Enhanced)|"The course is a manualized stress-reduction intervention with an integrated tech suite designed for timely detection and response to stress. Based on Cognitive-Behavioral Therapy & attachment theory, MB is divided into 3 sections: Pleasant Activities; Thoughts; Contact with Others. Each module has been enhanced with mindfulness as a strategy to help center participants and facilitate practice of skills. Participants receive skills training in each of the three sections as tools to improve and manage their mood. The MB course emphasizes developing & strengthening the bond with the baby. The technology enhancement includes wearing a BioStamp sensor, and text message-based extra intervention content. Participants get worksheets linked to the 12 sessions."
15904409|NCT03615248|Device|BreatheSuite|"BreatheSuite (patent pending) is a device and mobile application developed by Mr. Brett Vokey, an engineering student at Memorial University of Newfoundland. BreatheSuite has been recognized by numerous provincial competitions, featured at the Eastern Health Innovation Showcase, and was recently selected as a finalist for the New York Health Innovation Challenge.
~This device attaches to metered dose inhalers and it can determine if:
~the dose was given,
~the metered dose inhaler was properly shaken,
~the metered dose inhaler is properly aligned,
~the flow of medication is appropriate and
~there is no accidental exhalation into the inhaler."
15904410|NCT03615209|Device|Transauricular vagus nerve stimulation|Stimulation will be performed for 150 minutes (throughout the entire OGTT).
15904411|NCT03615209|Device|Transauricular sham stimulation|Sham stimulation will be performed for 150 minutes (throughout the entire OGTT)
15904412|NCT03615196|Drug|USB005 (aclerastide) Ophthalmic Solution|Aclerastide ([Nle3]-Angiotensin II (1-7)) is aseptically formulated in USB005 Ophthalmic Solution for topical ophthalmic administration. Active pharmaceutical ingredient (API) levels ranging from 0.03% to 0.45% are formulated in a sterile vehicle consisting of 0.06% Sodium Phosphate Monobasic Anhydrous, USP; 3% Glycerol, USP; 1.4% Polyvinyl Alcohol, USP; and 0.5% Hydroxyethylcellulose (HEC 250 HHX), NF in Sterile Water for Injection, USP.
15904413|NCT03615196|Drug|USB005 Ophthalmic Solution Placebo|A clinical placebo formulated with the same excipients and packaged in the same container closure system as the active product, USB005 (aclerastide) Ophthalmic Solution.
15904414|NCT03615183|Drug|MK-8527|Single oral capsule
15904415|NCT03615157|Other|Exercise rehabilitation|Patients will be submitted to a twelve-week combined exercise program of aerobic and peripheral muscle training. They will be randomized in two groups: Home-based and Supervised.
15904416|NCT03615144|Drug|Melphalan|Melphalan 70 mg/m2/day x 2
15904417|NCT03615144|Drug|Thiotepa|Thiotepa 7.5 mg/kg/day x 2
15904418|NCT03615144|Drug|Clofarabine|Clofarabine 20-30 mg/m2/day x 5
15904419|NCT03615144|Drug|Fludarabine|Fludarabine 30 mg/m2/day x 5
15904420|NCT03615144|Drug|Anti-Thymocyte Globulin (Rabbit) (Thymoglobulin®)|antithymocyte globulin (ATG) (rabbit ATG 2.5 mg/kg/day x 3 or equine ATG 15 mg/kg/day x 3 (or 40 mg/kg/day x 1 equine ATG if rabbit ATG is not tolerated) during pre-transplant conditioning to deplete host T-cells that could hamper engraftment.
15904421|NCT03615144|Procedure|CliniMACS reagents|Products will then undergo TCR-αβ+ and CD-19 depletion using the CliniMACS.
15904422|NCT03615131|Diagnostic Test|MRI-TRUS fusion prostate biopsy|First an advanced MRI prostate image is obtained, annotated and recorded by the Radiology of the Kantonsspital Winterthur. Next, using special fusion technology, the recorded MRI image is fused with a live transrectal ultrasound by the Urologist who performs a MRI/TRUS fusion biopsy.
15904423|NCT03615118|Other|IVR/SMS|Daily SMS messages asking participants to report their mood on a 1 to 9 scale; An automated phone system for monitoring and improving self-care and health outcomes
15904424|NCT03615118|Other|SMS|Daily SMS messages asking participants to report their mood on a 1 to 9 scale
15904425|NCT03615105|Radiation|Hyperfractionated total body irradiation|Hyperfractionated TBI is administered by a linear accelerator at a dose rate of <20 cGy/minute. Doses of 125 cGy/fraction are administered at a minimum interval of 4 hours between fractions, three times/day for a total of 11 or 12 doses (1,375 or 1,500 cGy) over 4 days (days -9 through -6).
15904426|NCT03615105|Drug|Thiotepa|Thiotepa 5 mg/kg IV
15904432|NCT03615105|Procedure|HPC(A) stem cell allograft|All patients will receive anti-thymocyte globulin based conditioning followed by a G-CSF mobilized, peripheral blood hematopoietic progenitor cell HPC(A) product depleted of TCR-α/β+ Tlymphocytes using the CliniMACS system.
15904433|NCT03615105|Drug|Rituximab|Rituximab 200 mg IV flat dose
15904434|NCT03615105|Device|Rabbit antithymocyte globulin|Rabbit antithymocyte globulin dosing per nomogram. This dynamic nomogram is based on absolute lymphocyte count at the start of conditioning and can result in either 2 or 3 day ATG administration. If a patient requires 2 day administration the subjequent chemotherapies may be moved forward by one day at the treating physician's discretion.
15904435|NCT03615092|Procedure|Root coverage with extended flap technique and acelular dermal matrix|At one side, the root coverage have been done with a extended flap technique and acellular dermal matrix and there was no cervical lesion. At the other side, the same technique was performed, but the gingival recession was associated with a noncarious cervical lesion.
15904436|NCT03615079|Behavioral|Cognitive behavioral therapy|An 8-week, internet-based cognitive behavioral therapy (CBT) program for depression
15904437|NCT03615066|Drug|Placebo|Tablet(s) administered orally every 7 days for 24 doses in fasted state
15904438|NCT03615066|Drug|Selgantolimod|Tablet(s) administered orally every 7 days for 24 doses in fasted state
15904439|NCT03615066|Drug|TAF|Tablet(s) administered orally once daily with food
15904440|NCT03615053|Other|Implementation of WAPPS-Hemo personalized dosing regimen|Twelve months after enrollment in the study, WAPPS-Hemo will be used to calculate each patients individual pharmacokinetic estimate. Once completed, the WAPPS-Hemo clinical calculator will be used to calculate the optimal regimen based on individual needs.
15904441|NCT03615040|Drug|MSTT1041A|"MSTT1041A (RO7187807; formerly made by Amgen [AMG] and referred to as AMG 282) is a novel biopharmaceutical that blocks signaling of interleukin (IL)-33, an inflammatory cytokine of the IL-1 family and member of the newly discovered alarmin class of molecules. IL-33 is released from airway epithelial cells in response to allergens, irritants, and infection. IL-33 release can trigger acute exacerbations in both asthma and COPD. MSTT1041A has the ability to block inflammation,prevent exacerbations, and improve lung function and quality of life.
~Anti-ST2 is presented as sterile, clear, and colourless to slightly yellow liquid. Each sterile vial is filled with a 1 mL deliverable volume of 70 mg/mL. It is formulated with 15 mM sodium acetate, 9.0% (w/v) sucrose, 0.01% (w/v) polysorbate 20, pH 5.2."
15904442|NCT03615040|Drug|Placebo|Placebo for Anti-ST2 (MSTT1041A) is formulated with 10 mM sodium acetate, 9.0% (w/v) sucrose, 0.004% (w/v) polysorbate 20, pH 5.2, and is supplied in an identical vial configuration.
15904443|NCT03615027|Behavioral|Dementia-specific advance care planning|see detailed description
15904444|NCT03615014|Other|Filling questionnaires|Questionnaires will be submitted to patients during their visit to emergency service and 3 months later to evaluate the prevalence of Post Traumatic Stress Disorder and to identify predictive biopsychosocial factors
15904445|NCT03615001|Device|TDOC NXT|Assessing the Performance, Safety and Usability of our Next Generation T-DOC® NXT Catheter for Performing Urodynamic Studies
15904446|NCT03614988|Other|Evening Levothyroxine Administration|Bedtime levothyroxine intake, with 60-minute meal-free interval
15904447|NCT03614988|Other|Morning Levothyroxine Administration|Morning levothyroxine intake, 60 minutes before breakfast.
15904448|NCT03614975|Biological|Flucelvax inactivated influenza vaccine|Participants randomized to this study influenza vaccine arm will receive Flucelvax inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)
15904449|NCT03614975|Biological|Fluzone inactivated influenza vaccine|Participants randomized to this study influenza vaccine arm will receive Fluzone inactivated influenza vaccine at baseline after the baseline blood draw is complete. (Provided that this vaccine is available clinically in time for the study.)
15904450|NCT03614962|Device|Warmth + TENS|"A hat device will offer the electrical stimulation (pulse width of 120 milliseconds at about 100 Hz with constant current 0.02mA-0.7 mA, intensity setting at sensory threshold) over 4 acupuncture points over the scalp, including Baihui (GV20), Sishencong (EX-HN1), Fengchi (GB20) and Shenting (GV24). Selection of acupuncture points has been based on the recommendation of traditional Chinese medicine.
~A custom-built warmth pad surrounding the TENS electrodes could produce the controlled comfortable warmth sensation, with default setting at 37degrees to 40 degrees Celsius."
15904451|NCT03614962|Device|Warmth + placebo-TENS|A custom-built warmth pad surrounding the TENS electrodes could produce the controlled comfortable warmth sensation, with default setting at 37degrees to 40 degrees Celsius. The TENS electrodes are presented in the cap but no output will be delivered via these electrodes.
15904452|NCT03614962|Device|TENS|A hat device will offer the electrical stimulation (pulse width of 120 milliseconds at about 100 Hz with constant current 0.02mA-0.7 mA, intensity setting at sensory threshold) over 4 acupuncture points over the scalp, including Baihui (GV20), Sishencong (EX-HN1), Fengchi (GB20) and Shenting (GV24). Selection of acupuncture points has been based on the recommendation of traditional Chinese medicine.
15904453|NCT03614962|Device|Warmth only|A custom-built warmth pad surrounding the TENS electrodes could produce the controlled comfortable warmth sensation, with default setting at 37degrees to 40 degrees Celsius. No built-in TENS electrodes in the cap.
15904454|NCT03614962|Device|control|No warmth pad and TENS electrodes presented in the cap.
15904455|NCT03614949|Radiation|Stereotactic body radiation therapy (SBRT)|SBRT with 24 Gy in 3 fractions to participants with ≥ 2 metastatic sites.
15904456|NCT03614949|Drug|Atezolizumab|Atezolizumab 1200 mg intravenously (IV) every 3 weeks.
15904457|NCT03614936|Other|Geriatric Screening Test G8|Geriatric screening test (Oncodage-G8). The oncologist realizes it and proposes the oncological treatment which seems to him then the most adapted (treatment which can be different from that proposed after the oncological evaluation only).
15904458|NCT03614936|Other|Geriatric fragility test GERICO|"GERICO geriatric frailty test (if possible the same day as the G8 and in any case in the same week): Realized by the oncologist, it includes:
~the socio-cultural evaluation scale,
~the ADL autonomy questionnaire,
~assessment of locomotor disorders,
~nutritional assessment,
~the MMSE Cognitive Function Evaluation Questionnaire,
~the GDS-4 mood rating scale,
~the comorbidity assessment test (Charlson Index)"
15904459|NCT03614923|Biological|Etokimab|SC, Q4W
15904460|NCT03614923|Biological|Placebo|SC, Placebo Q4W
15904461|NCT03614923|Biological|Etokimab|SC, Q8W
15904462|NCT03614910|Device|Nanoknife Irreversible Electroporation|Irreversible electroporation will be delivered between electrodes that are placed by intraoperative ultrasound guidance around the tumor
15904463|NCT03614897|Behavioral|Education|Education on guidelines for care of individuals at risk of falling
15904464|NCT03614884|Behavioral|Gambling and Smoking Treatment|The treatment condition will have access to 7 treatment modules on content surrounding both gambling and smoking behaviours. Participants will have 8-weeks to complete them. The content of all modules is derived from Cognitive Behavioural Therapy and Motivational Interviewing. Through module engagement, participants will identify goals related to gambling and smoking behaviours, learn strategies to cope with cravings and triggers, and learn how to prevent relapse. Participants will have immediate access to all modules, and it will be recommended that they work through the modules sequentially. Participants in this condition will also be provided with nicotine replacement therapy (NRT) in the form of nicotine patches to use for the duration of the study.
15904465|NCT03614884|Behavioral|Gambling only treatment|The control condition will have access to 7 treatment modules on content surrounding gambling only. Participants will have 8-weeks to complete them. The content of all modules is derived from Cognitive Behavioural Therapy and Motivational Interviewing. Through module engagement, participants will identify goals related to gambling behaviours, learn strategies to cope with cravings and triggers, and learn how to prevent relapse. Participants will have immediate access to all modules, and it will be recommended that they work through the modules sequentially.
15904466|NCT03614871|Other|Epidemiological study|
15904467|NCT03614858|Biological|CART-19/22|Split intravenous infusion of CART-19/22 cells of (Dose escalating infusion of 1 - 20 x10^6 CART-19/22 cells/kg).
15904468|NCT03614845|Procedure|VCV|after induction for anesthesia patients will be supported by mechanical ventilation on volume controlled ventilation mode
15904469|NCT03614845|Procedure|PCV-VG|after induction for anesthesia patients will be supported by mechanical ventilation on pressure controlled and volume guaranteed ventilation mode
15904470|NCT03614845|Diagnostic Test|lung ultrasonography|all patients will be performed lung ultrasonography pre and postoperatively
15904471|NCT03614832|Drug|Ticagrelor 90 mg|half-dose ticagrelor treatment (90 mg loading dose, then 90 mg once daily) for 1 week.
15904472|NCT03614832|Drug|Clopidogrel 150 mg|double standard-dose clopidogrel treatment (150 mg loading dose, then 150 mg once daily) for 1 week.
15904473|NCT03614819|Procedure|Diode laser group|Prophylaxis of the selected region for the study with Robson brush and prophylactic paste, washing and drying, followed by application of diode laser (Sirolaser, Sirona Dental Systems GmbH, Bensheim, Germany) with wavelength of 970 nm +/- 10 nm, maximum power of 7 W CW, 1mW guide beam and 320μm optical fiber. Irradiation will be performed on the entire occlusal surface in contact mode, with power of 0.7 W (energy of 70 mJ) and frequency of 10 Hz for 30 seconds, having an energy density of 222.82 J / cm2. The FieldMaxII-TOP power meter (Coherent, Inc, USA) will be used prior to and after the applications. The laser will be applied in a sweeping motion throughout the affected surface, the fiber being maintained positioned perpendicular to the occlusal surface throughout the movement. The irradiation time will be standardized in 30 seconds.
15904474|NCT03614819|Procedure|Glass Ionomer Sealing Group|Prophylaxis of the selected region for the study with Robson brush and prophylactic paste, washing and drying with cotton balls, followed by relative insulation with cotton rollers of the tooth in question, application of acid polyacrylic for 15 seconds throughout the surface, light drying with cotton ball, insertion of the high viscosity glass ionomer (Equia Forte in capsule - GC) through a specific applicator, after loss of the gloss of the digital pressure material with Vaseline for due drainage and surface protection of the material, removal of the excess, checking the occlusion with carbon paper, occlusal adjustments if necessary, superficial protection with petroleum jelly.
15904475|NCT03614806|Diagnostic Test|Simultaneous Transcutaneous and End-tidal CO2 measurements|Included patients will be invited to fill in the Nijmegen questionnaire. During the hyperventilation test, PtcCO2 (mmHg) will be recorded simultaneously with the standard End-tidal Cpartial pressure CO2 measurement
15904476|NCT03614793|Procedure|Cooled Radiofrequency Ablation of Medial Branch Nerves versus Facet Joint Injection of Corticosteroid for the Treatment of Lumbar Facet Syndrome|Radio frequency ablation (RFA) is a medical procedure in which heat is generated from high frequency electrical current in order to lesion (burn) nervous tissue.
15904477|NCT03614780|Behavioral|30 minutes outdoors|Participants were asked to add an additional 30 minutes of time spent outdoors during the last 5 days of participation
15904478|NCT03614767|Diagnostic Test|urodynamics|Bladder filling and pressure is measured by the insertion of probes within the bladder, urethra and anorectum.
15904479|NCT03614754|Diagnostic Test|Somatosensory evoked potentials|Stimulation of the pudendal nerve while recording at the sensory cortex.
15904480|NCT03614741|Drug|Tinzaparin continuous infusion|4500 IU continuous infusion of Tinzaparin
15904481|NCT03614741|Drug|Tinzaparin bolus|4500 IU bolus of Tinzaparin
15904482|NCT03614728|Drug|GSK3326595|GSK3326595 will be administered.
15904483|NCT03614728|Drug|5-Azacitidine|5-Azacitidine will be administered.
15904484|NCT03614715|Drug|Interferon Beta-1A|A single dose of Interferon Beta-1A (Stage 1: 30 or 60 µg, stage 2: 30 µg) was administered IM to healthy subjects (cross over treatment)
15904485|NCT03614702|Biological|1-dose cIPV + 2-doses bOPV (Candy)|Health subjects received 1-dose cIPV intramuscularly in the centre of anterolateral thigh followed by 2-doses bOPV(Candy) through mouth at 0, 28, 56 days schedule.
15904486|NCT03614702|Biological|1-dose sIPV + 2-doses bOPV (Candy)|Health subjects received 1-dose sIPV intramuscularly in the centre of anterolateral thigh followed by 2-doses bOPV(Candy) through mouth at 0, 28, 56 days schedule.
15904487|NCT03614702|Biological|2-doses cIPV + 1-dose bOPV (Candy)|Health subjects received 2-doses cIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose bOPV(Candy) through mouth at 0, 28, 56 days schedule.
15904488|NCT03614702|Biological|2-doses sIPV + 1-dose bOPV (Candy)|Health subjects received 2-doses sIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose bOPV(Candy) through mouth at 0, 28, 56 days schedule.
15904489|NCT03614702|Biological|2-doses cIPV + 1-dose tOPV (Candy)|Health subjects received 2-doses cIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose tOPV(Candy) through mouth at 0, 28, 56 days schedule.
15904535|NCT03614455|Drug|Itraconazole|Itraconazole (200 mg) oral solution (20 mL of 10 mg/mL)
15928442|NCT03431610|Drug|Vehicle|Placebo comparator
15904490|NCT03614702|Biological|2-doses sIPV + 1-dose tOPV (Candy)|Health subjects received 2-doses sIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose tOPV(Candy) through mouth at 0, 28, 56 days schedule.
15904491|NCT03614702|Biological|1-dose cIPV + 2-doses bOPV (Liquid)|Health subjects received 1-dose cIPV intramuscularly in the centre of anterolateral thigh followed by 2-doses bOPV(Liquid) through mouth at 0, 28, 56 days schedule.
15904492|NCT03614702|Biological|1-dose sIPV + 2-doses bOPV (Liquid)|Health subjects received 1-dose sIPV intramuscularly in the centre of anterolateral thigh followed by 2-doses bOPV(Liquid) through mouth at 0, 28, 56 days schedule.
15904493|NCT03614702|Biological|2-doses cIPV + 1-dose bOPV (Liquid)|Health subjects received 2-doses cIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose bOPV(Liquid) through mouth at 0, 28, 56 days schedule.
15904494|NCT03614702|Biological|2-doses sIPV + 1-dose bOPV (Liquid)|Health subjects received 2-doses sIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose bOPV(Liquid) through mouth at 0, 28, 56 days schedule.
15904495|NCT03614702|Biological|2-doses cIPV + 1-dose tOPV (Liquid)|Health subjects received 2-doses cIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose tOPV(Liquid) through mouth at 0, 28, 56 days schedule.
15904496|NCT03614702|Biological|2-doses sIPV + 1-dose tOPV (Liquid)|Health subjects received 2-doses sIPV intramuscularly in the centre of anterolateral thigh followed by 1-dose tOPV(Liquid) through mouth at 0, 28, 56 days schedule.
15904497|NCT03614676|Procedure|Blood sample collection|Venous blood samples will be collected from the maternal subjects at Day 1 and Day 56 of the study and at delivery.
15904498|NCT03614676|Procedure|Cord blood sample collection|Collection of cord blood samples from maternal subjects will occur, at delivery
15904499|NCT03614676|Other|Maternal Diary Card|Completion of Diary Card about health by pregnant woman/ mother, from enrolment through week 6 post delivery.
15904500|NCT03614676|Procedure|Nasal Swab collection|Collection of nasal swabs from infants with potential LRTIs, from birth to 12 months of age.
15904501|NCT03614676|Other|Infant Diary Card|Completion of Diary Card about health of infant from birth to 12 months of age.
15904502|NCT03614663|Drug|ZYN002 - CBD Transdermal Gel|Pharmaceutically manufactured. Cannabidiol (CBD) formulated as a clear gel (transdermal delivery)
15904503|NCT03614663|Other|Placebo Transdermal Gel|Placebo formulated as a clear gel (transdermal delivery)
15904504|NCT03614650|Biological|engineered immune cells|Engineered immune effector cells (EIE)
15904505|NCT03614637|Other|Cannabis use abstinence for 11 weeks|Cannabis user group will be asked to abstain from any form of Cannabis use for 11 weeks. During their contingency management phase/abstinence phase, they will be required to come to the clinic for 25 visits over an 11 week period of abstinence.
15904506|NCT03614624|Device|Comparative standard echocardiography between two devices : Vivid 9 General Electric and Epiq 7 Philips|Comparison of the various values of strain with the echograph General Electric and the electrograph Philips.
15904507|NCT03614611|Device|Contiform pessary|"Patients will be asked to use the device for 12 weeks and to become comfortable with self-insertion and self-removal. The device can be worn continuously for 1 month. When placed in the vagina it retains its shape and supports the urethra during episodes of varied intraabdominal pressure. During the assessment test (24 hours pad test), patients will be encouraged to undertake any activity that would normally induce stress leakage.
~The contiform device is approved by Health Canada since 2017-04-10 (Licence No.: 98950, Company ID: 134089, Device identifier: SKU 184)"
15904508|NCT03614598|Procedure|Insertion of LMA-UNIQUE(TM) device|LMA-UNIQUE(TM) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation
15904509|NCT03614598|Procedure|Insertion of LMA-SUPREME(TM) device|LMA-SUPREME(TM) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation
15904510|NCT03614598|Procedure|Insertion of I-GEL(R) device|I-GEL(R) single-use adult supraglottic airway device inserted during short general anesthesia under controlled ventilation
15904511|NCT03614585|Behavioral|12 weeks of High-intensity Interval Training|Cardiovascular exercise
15904512|NCT03614585|Behavioral|12 weeks of Moderate-Intensity Continuous Training|Cardiovascular exercise
15904513|NCT03614572|Behavioral|Group MI|refer to the arm description
15904514|NCT03614546|Radiation|SBRT|Stereotactic Body Radiation Therapy (SBRT)
15904515|NCT03614546|Radiation|IMRT|Intensity-modulated Radiation Therapy (IMRT)
15904516|NCT03614546|Procedure|Hepatectomy|Hepatectomy
15904517|NCT03614546|Procedure|TACE|transarterial chemoembolization (TACE)
15904518|NCT03614533|Biological|Vi-Typhoid Conjugate Vaccine (Vi-TCV)|Single 0.5-ml intramuscular injection
15904519|NCT03614533|Biological|Inactivated Poliovirus Vaccine (IPV)|Single 0.5-ml intramuscular injection
15904520|NCT03614520|Other|Administration of olive oil|25 mL of extra virgin olive oil
15904521|NCT03614520|Other|Administration of red wine|150 mL or Red Wine
15904522|NCT03614520|Other|Combination of red wine and olive oil|150 mL of Red wine + 25 mL of Extra Virgin Olive oil will be administred at the same time
15904523|NCT03614520|Other|Water|Mineral water will be given as placebo
15904524|NCT03614520|Other|Dark beer|250 mL of IPA beer (alcohol 8.5% vol)
15904525|NCT03614520|Other|Light Beer|250 mL of blonde ale beer (alcohol 4,5% vol)
15904526|NCT03614520|Other|Alcohol free Beer|250 mL of alcohol free beer (alcohol 0.0% vol)
15904527|NCT03614507|Device|FreeO2 (modèle FO2-220-00) automatic oxygen flow titration|Automatic adjustment of oxygen flow titration through the FreeO2 device. The monitor allows continuous monitoring and recording of SpO2 and Heart rate
15904528|NCT03614507|Device|FreeO2 (modèle FO2-220-00) manual oxygen flow titration|Manual oxygen flow titration performed by the healthcare provider in charge of the patient (nurse, physician). For this group, the FreeO2 device will only monitor and record SpO2 and heart rate.
15904529|NCT03614494|Drug|Piroxicam 40 mg|Additional co-treatment
15904530|NCT03614494|Drug|Levonorgestrel 1.5mg|Standard treatment
15904531|NCT03614481|Genetic|Sampling|Sampling
15904532|NCT03614468|Other|Formula A|Formula A is to be feed as the sole source of nutrition for 52 weeks to healthy term infants.
15904533|NCT03614468|Other|Formula B|Formula B is to be feed as the sole source of nutrition for 52 weeks to healthy term infants.
15904534|NCT03614455|Drug|Milademetan|Milademetan 100 mg capsule for oral administration
15904536|NCT03614455|Drug|Posaconazole|Posaconazole (200 mg) oral suspension (5 mL of 40 mg/mL)
15904537|NCT03614442|Other|slopped shoulder implant|different implant design to enhance soft and hard tissue outcome
15904538|NCT03614429|Drug|Chlorhexidine gel will be prepared according to an international product Instillagel®|"Pre-operatively, urethral instillation with Chlorhexidine gel will be performed for the Ch group, while for the control group, instillation will not be performed.
~Chlorhexidine gel will be prepared according to an international product; Instillagel®, used prior to urethral catheterization as analgesic / anti-septic, with the following composition:
~6ml of Instillagel® gel contain: 117.6mg lidocaine hydrochloride, 3.1mg chlorhexidine digluconate, 3.8mg methyl hydroxybenzoate (E218), 1.6mg propyl hydroxybenzoate (E216) 11ml of Instillagel® gel contain: 215.7mg lidocaine hydrochloride, 5.8mg chlorhexidine digluconate, 6.9mg methyl hydroxybenzoate (E218), 2.9mg propyl hydroxybenzoate (E216)
~The other ingredients are:
~Hyetellose, propylene glycol* (E 1520), sodium hydroxide and purified water. Intra-operatively, the Ch group will receive Chlorhexidine instillation again before surgery, while the control group will not."
15904539|NCT03614416|Device|EOXY device|Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard
15904540|NCT03614416|Device|Gold standard oximeter|Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard
15904541|NCT03614416|Procedure|SaO2 sampling|Sp02 and HR measures from EOXY device are simulateously compared to gold standard measures : Sa02 sampling measures and pulse oximeter gold standard
15904542|NCT03614403|Drug|vitamin D|Fat-soluble vitamin D injection contain of 300,000 IU vitamin D that given via intramuscular injection
15904543|NCT03614390|Behavioral|mindfulness based cognitive therapy (MBCT)|a well described and structured intervention, which is published previously. The psychoeducation materials in the MBCT will be titrated to discuss about low mood and burnout
15904544|NCT03614377|Diagnostic Test|Device interrogation|All devices are interrogated at every follow-up, and two questionnaires are performed 2 years after enrollment.
15904545|NCT03614364|Drug|nanoxel|D1 Nanoxel 75 mg/m2 + D5W 100mL MIV over 1hr D1 Herzuma 8mg/kg (loading dose) + N/S 250mL miv over 90mins 6mg/kg (maintenance) + N/S 250mL MIV over 30mins (since 2 cycle) repeated every 3 weeks
15904546|NCT03614364|Drug|herzuma|D1 Nanoxel 75 mg/m2 + D5W 100mL MIV over 1hr D1 Herzuma 8mg/kg (loading dose) + N/S 250mL miv over 90mins 6mg/kg (maintenance) + N/S 250mL MIV over 30mins (since 2 cycle) repeated every 3 weeks
15904547|NCT03614351|Dietary Supplement|Protein (PROT)|Participants will receive Combat Protein Powder made by MusclePharm in an amount sufficient to take 80g daily until their next visit. They will be encouraged to ingest 40 g after exercise and 40 g before bed which will partly comprise their daily goal. They will be educated on the concept of complete high quality proteins, and that some proteins can facilitate muscle growth greater than others. Additionally, they will receive meal plan ideas and shopping tips that will facilitate healthy and economical protein consumption up to or beyond their daily goal.
15904548|NCT03614351|Other|Control (CONT)|Instructed not to alter their diet based on the app, and to continue to eat as they normally would.
15904549|NCT03614338|Behavioral|Small changes weight loss program|"This intervention uses a small-changes approach to calorie reduction (operationalized as 6 100-calories changes per day) along with increasing leisure-time physical activity and self-regulation strategies to produce weight loss. The intervention will be delivered via 12 face-to-face group sessions."
15904550|NCT03614325|Other|Virtual Reality Immersive Relaxation|The software developed by VRHealth allows patients to select from scenery such as mountains, the beach or from a selection of short videos, which are intended to promote relaxation.
15904551|NCT03614299|Other|Ecological symptom measurements using a webapp|A webapp will be installed on the patients' smartphone, which will be used to collect everyday the symptoms of the patients (ESSPRI score)
15904552|NCT03614299|Diagnostic Test|Interferometry|Evaluation of the mebomian function using the LipiView methodology
15904553|NCT03614286|Diagnostic Test|culture and pcr|The swab immersed in Diamond's Modified medium culture tube and squeezed for cultivation and examined daily with a light microscope to identify T. vaginalis Samples from culture will be placed in 1 ml of a commercial PCR transport medium (AMPLICOR; Roche Diagnostic Systems, Branchburg, N.J.) and kept at 4°C until arrival at the laboratory within 4 days of collection. An equal volume of specimen diluent (AMPLICOR) was added to the sample , and the preparation was mixed, incubated at room temperature for 10 min, and stored at -70°C until tested.
15904554|NCT03614273|Drug|Hypertonic saline|The nebulizations were administered via an oxygen run jet nebulizer, with a flow of 6-7 litres/min.
15904555|NCT03614273|Drug|Adrenaline|The nebulizations were administered via an oxygen run jet nebulizer, with a flow of 6-7 litres/min.
15904556|NCT03614260|Device|Paradise Renal Denervation System|Following renal angiogram according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
15904557|NCT03614260|Procedure|Renal Angiogram|Following renal angiogram to standard procedures, subjects remain blinded and renal angiogram is considered the sham procedure.
15904558|NCT03614247|Procedure|Retrograde intrarenal surgery|The procedure was performed with the patient in the dorsal lithotomy position under general anesthesia. Firstly, diagnostic ureteroscopy was done with a 6/7.5 Fr semi-rigid ureteroscope (Richard Wolf, Knittlingen, Germany). A 0.035mm double-tipped sensor guidewire was placed to the renal pelvis. A 10/12 Fr ureteric access sheath (Cook Medical, Indiana, USA) was used. A 7.5 Fr flexible ureteroscope (Flex X2, Karl Storz, Tuttlingen, Germany) was used for the main procedure. The stones were fragmented using a Holmium:Yttrium Aluminum Garnet laser (272 microns). At the end of each procedure, a double-j ureteric catheter and urethral catheter were routinely placed.
15904559|NCT03614247|Procedure|Micro-PNL|The PNL procedures were performed with the patient in the prone position under general anesthesia. A 6-F ureteric catheter was placed at the beginning of the procedure. Calyceal access was provided using a 22-G Chiba needle. A 0.038mm sensor-tipped guidewire was inserted through the calyceal puncture into the renal pelvis. After tract dilatation, a sheath was inserted. The instruments used were a 4.8 Fr for micro PNL (PolyDiagnost, Pfaffenhofen, Germany). Stone fragmentation was carried out using laser in micro PNL. No nephrostomy was placed in any patient whom underwent micro PNL surgical technique. A double- j stent was placed in necessary (e.g., pelvis perforation, rest stone, stone migration to ureter). A urethral catheter was placed routinely in all patients.
15904560|NCT03614247|Procedure|Ultra-mini PNL|The PNL procedures were performed with the patient in the prone position under general anesthesia. A 6-F ureteric catheter was placed at the beginning of the procedure. Calyceal access was provided using a 22-G Chiba needle. A 0.038mm sensor-tipped guidewire was inserted through the calyceal puncture into the renal pelvis. After tract dilatation, a sheath was inserted. The instruments used were a 7.5 Fr for ultramini PNL (Karl Storz, Tuttlingen, Germany). Stone fragmentation was carried out using laser in ultramini PNL. No nephrostomy was placed in any patient whom underwent ultramini PNL surgical technique. A double- j stent was placed in necessary (e.g., pelvis perforation, rest stone, stone migration to ureter). A urethral catheter was placed routinely in all patients.
15904561|NCT03614247|Procedure|Mini-PNL|The PNL procedures were performed with the patient in the prone position under general anesthesia. A 6-F ureteric catheter was placed at the beginning of the procedure. Calyceal access was provided using a 22-G Chiba needle. A 0.038mm sensor-tipped guidewire was inserted through the calyceal puncture into the renal pelvis. After tract dilatation, a sheath was inserted. The instruments used were a 12 Fr for mini PNL (Karl Storz, Tuttlingen, Germany). Stone fragmentation was carried out using pneumatic, ultrasonic or laser in mini PNL. No nephrostomy was placed in any patient whom underwent mini PNL surgical technique. A double- j stent was placed in necessary (e.g., pelvis perforation, rest stone, stone migration to ureter). A urethral catheter was placed routinely in all patients.
15904562|NCT03614247|Procedure|Standard PNL|The PNL procedures were performed with the patient in the prone position under general anesthesia. A 6-F ureteric catheter was placed at the beginning of the procedure. Calyceal access was provided using a 22-G Chiba needle. A 0.038mm sensor-tipped guidewire was inserted through the calyceal puncture into the renal pelvis. After tract dilatation, a sheath was inserted. The instruments used were a 24 Fr for standard PNL (Karl Storz, Tuttlingen, Germany). Stone fragmentation was carried out using pneumatic, ultrasonic or laser in standard PNL. A nephrostomy was placed in all standard PNL patients at the end of the procedure
15904563|NCT03614234|Biological|pegunigalsidase alfa|Recombinant human alpha galactosidase A
15904564|NCT03614221|Drug|Lindioil ointment|Each gram contains 200µg of indirubin. Apply 0.5 g of ointment per 10 cm x 10 cm of affected skin areas twice daily for 6 weeks.
15904565|NCT03614221|Drug|Protopic ointment 0.1%|Each gram contains (w/w) 0.1% of tacrolimus. Apply 0.1 g of ointment per 10 cm x 10 cm of affected skin areas twice daily for 6 weeks.
15904566|NCT03614208|Behavioral|Home-care rehabilitation group (HCRG)|The exercise program consists of aerobic exercise on a stationary bike, muscular endurance training of the upper limb and stretching exercises for finger joint motion. The exercise on the stationary bike and muscular endurance training will be performed on alternate days, three times a week.
15904567|NCT03614195|Device|MCDTT|The MCDTT group will undertake sitting to standing, standing balance, and treadmill walking training while concurrently perform motor and cognitive tasks.
15904568|NCT03614195|Device|MDTT|The MDTT group will train the same set of sitting to standing, standing balance, and walking activities as the MCDTT group while simultaneously performing only motor task.
15904569|NCT03614195|Device|CDTT|The CDTT group will train the same set of sitting to standing, standing balance, and walking activities as the MCDTT group while simultaneously performing only cognitive task.
15904570|NCT03614182|Device|physical training concurrent with cognitive training|The P+C group will undertake standing balance, stepping, and treadmill walking training while concurrently perform cognitive tasks.
15904571|NCT03614182|Device|physical training followed by cognitive training|The P-then-C group will train the same set of standing balance, stepping, and treadmill walking activities as the P+C group while followed by cognitive training later.
15904572|NCT03614182|Device|physical training without cognitive training|The P group will only train the same set of standing balance, stepping, and treadmill walking activities as the other two groups.
15904573|NCT03614169|Procedure|Implantation of a HIS-pacing lead|This intervention is attempted first
15904574|NCT03614169|Procedure|Implantation of a LV-pacing lead|This intervention is attempted first
15904575|NCT03614156|Drug|Rapastinel|Rapastinel 450 mg or 225 mg (prefilled syringe, weekly intravenous IV administration) or Rapastinel 450 mg or 225 mg (prefilled syringe, clinically driven schedule IV administration, variable interval, placebo on intervening weeks)
15904576|NCT03614156|Drug|Placebo|Placebo (prefilled syringe, weekly IV administration)
15904577|NCT03614130|Device|LID011121 contact lens|Investigational silicone hydrogel contact lens
15904578|NCT03614130|Device|Comfilcon A contact lens|Commercially available silicone hydrogel contact lens
15904579|NCT03614117|Dietary Supplement|Lactobacillus salivarius PS7 during 6 months|7 months intervention study: A 6 months intervention period and 1 month follow-up after intervention finishing time. During the 6 months of intervention the participants will intake one daily dose of the product that contains 1*10E9 CFU of L. salivarius PS7. Then, a 1 month follow-up period will be completed.
15904580|NCT03614117|Dietary Supplement|Lactobacillus salivarius PS7 during 3 months|7 months intervention study: A 6 months intervention period and 1 month follow-up after intervention finishing time. During the 3 months of intervention the participants will intake one daily dose of the product that contains 1*10E9 CFU of L. salivarius PS7. After that, the participants will intake one daily dose of the placebo. Then, a 1 month follow-up period will be completed.
15904581|NCT03614117|Dietary Supplement|placebo|7 months intervention study: A 6 months intervention period and 1 month follow-up after intervention finishing time. During the 6 months of intervention the participants will intake one daily dose of placebo supplement.Then, a 1 month follow-up period will be completed.
15904582|NCT03614104|Behavioral|Mobile Health Technology (short message service)|Health education through mobile technology with Short Message Service (SMS)
15904583|NCT03614091|Procedure|Erector spinae plane block|20 ml Bupivacaine 0.5% below erector spinae muscle groups
15904584|NCT03614091|Procedure|Paravertebral plane block|20 ml Bupivacaine 0.5% between pleura and costotransverse ligament
15904585|NCT03614078|Drug|PRCL-02|Oral tablets
15904586|NCT03614078|Drug|Placebo|Oral tablets
15904587|NCT03614065|Drug|endostar|endostatin
15904588|NCT03614065|Drug|Placebos|saline solution
15904589|NCT03614065|Radiation|radiotherapy|radiotherapy
15904590|NCT03614052|Drug|Tamsulosin Hydrochloride 0.4 milligrams|Tamsulosin hydrochloride 0,4mg for 5 days before ureteroscopic treatment of urolithiasis
15933824|NCT03389685|Other|Saline Placebo|saline solution
15904591|NCT03614052|Drug|Placebo Oral Tablet|Placebo oral tablet 1 tablet per day for 5 days before ureteroscopic treatment of urolithiasis
15904592|NCT03614039|Dietary Supplement|"Symbiter Forte"|"Symbiter Forte which contains combination of smectite gel (250 mg), and biomass of 14 alive probiotic strains: Lactobacillus + Lactococcus (6×1010 CFU/g), Bifidobacterium (1×1010/g), Propionibacterium (3×1010/g), Acetobacter (1×106/g)"
15904593|NCT03614039|Dietary Supplement|Placebo|
15904594|NCT03614026|Behavioral|Teachers and Parents as Partners|Family-school partnership intervention
15904595|NCT03614013|Other|Immunotherapy responders/non-responders|paraffin samples will be collected retrospectively along with clinical data
15904596|NCT03614000|Other|Screening Questionnaires|"Measurement tools:
~Social Responsiveness Scale (SRS-2) is a validated 65-item scale for the screening of ASD that requires parents to rate the child's behaviors in the previous 6 months. The questionnaire assesses interpersonal behavior, communication and repetitive/stereotypic behavior characteristics of ASD.
~The Aseba Questionnaires are validated diagnostic tools that can be filled in by the parents, teachers or children to evaluate various behavioral and emotional problems. The CBCL assesses internalizing (i.e., anxious, depressive and over-controlled) and externalizing (i.e., aggressive, hyperactive, noncompliant and under-controlled) behaviors.
~The VG&O The VG&O is a questionnaire developed in Dutch that gives a subscale of parental stress (OBVL), family functioning (VGFO), education habits (VSOG) and life events (VMG). The OBVL will be used"
15904597|NCT03613987|Device|NAVA technology to synchronize NIPPV|Neurally adjust ventilator assist is used to synchronize the NIPPV
15904598|NCT03613974|Drug|Lidocaine|patients will receive different lidocaine concentrations
15904599|NCT03613961|Drug|Anesthetics|The ANS plays an important role in the regulation of hemodynamics during anesthesia. Manually blous of propofol during induction anesthesia is reported to reduce both sympathetic and parasympathetic tone; however, it is not clear whether the changes in heart rate variability are associated with propofol concentration. We will observe the relationship of anesthetics and HRV dynamics.
15904600|NCT03613935|Other|Product 1|Comparison with products 2, 3, and 4
15904601|NCT03613935|Other|Product 2|Comparison with products 1, 3, and 4
15904602|NCT03613935|Other|Product 3|Comparison with products 1, 2, and 4
15904603|NCT03613935|Other|Product 4|Comparison with products 1, 2, and 3
15904604|NCT03613922|Other|Early Manual Therapy|Mulligan's Mobilization with Movement technique for radiocarpal,ulnocarpal, distal radioulnar and proximal radioulnar joints was applied.
15904605|NCT03613922|Other|Routine Physiotherapy|Routine physiotherapy program consisted of range of motion, flexibility and strengthening exercises, and home exercise program was applied.
15904606|NCT03613909|Device|CP950|Off The Ear (OTE) Cochlear Implant Sound Processor
15904607|NCT03613909|Device|BTE|Behind The Ear (BTE) Cochlear Implant Sound Processor
15904608|NCT03613896|Procedure|conventional dentures|conventional dentures
15904609|NCT03613896|Procedure|3d printed denture|construction of a 3d printed denture through a recent method instead of conventional heat processing
15904610|NCT03613883|Procedure|Endovascular management|"Embolic materials (coils / glue): the glue will be routinely used when access into the aneurysm's outflow vessel will be unattainable.
~Endovascular stent to slow the flow inducing thrombosis of the sac of aneurysm. CT angiography will be performed later to evaluate and confirm the diagnosis and viability of the endovascular procedure"
15904611|NCT03613870|Device|PermeaDerm|Wound treatment with PermeaDerm
15904612|NCT03613870|Device|Mepilex Ag|Wound treatment with Mepilex Ag
15904613|NCT03613857|Drug|Clopidogrel|8 tablets 75 mg clopidogrel loading dose before PCI
15904614|NCT03613857|Drug|Ticagrelor 90mg|2 tablets 90 mg brilique before PCI
15904615|NCT03613844|Drug|DHA|DHA supplementation
15904616|NCT03613844|Drug|Placebo|Placebo for DHA
15904617|NCT03613831|Device|patient who used Rhythmia system and Orion catheter|suitable for Rhythmia system and Orion catheter according to relevant clinical guidelines and products instruction for use, per investigator's discretion
15904618|NCT03613818|Behavioral|eCHECKUP TO GO|eCHECKUP TO GO is a personalized normative feedback intervention intended to help participants make better choices about alcohol use by changing beliefs about alcohol, alcohol expectancies, and perceptions of peer drinking
15904619|NCT03613805|Device|Dexcom G5-Eversense|Patients will wear sensor for 3 months, monitor blood capillary values 4 times/day. At the beginning and at the end of the period HbA1c will be measured and questionnaires will be administered
15904620|NCT03613805|Device|Eversense-Dexcom G5|"Patients will wear sensor for 3 months, monitor blood capillary values 4 times/day. At the beginning and at the end of the period HbA1c will be measured and questionnaires will be administered.
~After 30-50 days of sensor implantation patients will wear also Dexcom G5 for a week to compare accuracy simultaneously"
15904621|NCT03613792|Drug|Remifentanil|Opioid analgesic
15904622|NCT03613792|Drug|Fentanyl|Opioid analgesic
15904623|NCT03613792|Drug|Midazolam|Benzodiazepine
15904624|NCT03613792|Drug|Ketamine|Analgesic
15904625|NCT03613779|Combination Product|LUS-guided therapy|Lung ultrasound guided therapy; if pulmonary congestion (more or equal than 3 B-lines), high dose (80-120mg PO/day furosemide) will be prescribed until next follow up re-assessment. If no congestion (less than 3 B-lines), low dose (0-40mg PO/day furosemide) will be prescribed until next follow up re-assessment
15904626|NCT03613779|Other|Standard of Care|Standard of care will be provided.
15904627|NCT03613766|Other|Physical activity program|
15904628|NCT03613753|Drug|irinotecan plus lobaplatin|irinotecan plus lobaplatin chemotherapy
15904629|NCT03613753|Drug|irinotecan|irinotecan chemotherapy alone
15904630|NCT03613740|Drug|Fucoxanthin|Intervention will be administered 30 minutes before breakfast.
15904631|NCT03613740|Drug|Placebo|Intervention will be administered 30 minutes before breakfast.
15904632|NCT03613727|Drug|Intravenous (IV) and oral Vitamin C|"Intravenous (IV) vitamin C 50 mg/kg/day divided in 3 doses beginning on posttransplant Day +1 and continuing through Day +14; each dose (16.7 mg/kg) given in 50 mL of 5% dextrose and water over 30 minutes every 8 hours
~• After completion of the IV vitamin C doses, oral vitamin C 500 mg twice each day beginning on Day +15 and continuing until Day +180"
15904695|NCT03613207|Procedure|Blood sampling|8 blood samples will be collected in order to assess systemic lidocaine/prilocaine concentrations pre-dose (1 sample) and 24 hours post dose (7 samples)
15904633|NCT03613714|Other|At-home Blood Pressure Monitoring|Participants will use over-the-counter digital monitor to measure blood pressure and pulse rate at home. Automatically averages the last 3 readings taken over 10 minutes.
15904634|NCT03613688|Dietary Supplement|Deepure|Pu'erh Tea extract
15904635|NCT03613675|Device|Video games|"The 4 videos games consists of:
~Asthmonaut, a desktop game in which the child navigates through different scenarios and interacts with nine characters to learn about asthma symptoms and management (30 minutes)
~Lung Launcher, a mobile game in which the character encounters different asthma triggers (customizable to the child) and the child has to find the correct preventive method to address each trigger (4 minutes)
~Asthma Heroes, a desktop game where the player interacts with several characters to learn about their symptoms, treatment and context, and collects objects to help them manage their asthma (30 minutes)
~Bloïd, a mobile game where the player uses a pressure sensor as an input device to guide a spacecraft and destroy meteorites in its path (4 minutes)."
15904636|NCT03613662|Drug|SP-102|Injection
15904637|NCT03613649|Drug|AZD0914|Spiropyrimidinetrione antibacterial drug, which inhibits bacterial DNA synthesis by a novel mechanism. Powder will be reconstituted in 60 mL of tap water and dosed orally after an overnight fast. After the cup containing 60 mL of zoliflodacin is taken, approximately 60 mL of tap water will be added to the cup and consumed by the subject to chase the initial dose.
15904638|NCT03613649|Drug|Moxifloxacin|Broad-spectrum 8-methoxy fluoroquinolone with activity against both Gram-positive and Gram-negative bacteria, including anaerobes. A single, commercially-available, film-coated, 400-mg tablet of moxifloxacin hydrochloride will be administered orally with 120 mL of tap water.
15904639|NCT03613649|Other|Placebo|Composed of 4 g of the same excipients found in zoliflodacin. Powder will be reconstituted in 60 mL of tap water and dosed orally after an overnight fast. After the cup containing 60 mL of placebo is taken, approximately 60 mL of tap water will be added to the cup and consumed by the subject to chase the initial dose.
15904640|NCT03613636|Diagnostic Test|Enzyme-linked immunospot (ELISpot) assay [Blood]|The ASC ELISpot will be developed based on the improved methods recently described [Nat Protoc 2013;8:1073-87]. This protocol allows rapid (6-8 h) detection of specific ASCs in small volumes (1-2 ml) of blood. M. pneumoniae protein P1 (50 μl/ml) will be used as antigen. The optimal concentration of coating antigen will be assessed in advance in two-fold serial dilutions for clear spot definition. The M. pneumoniae-specific T cell ELISpot will be developed based on methods recently described [Nat Protoc 2009;4:461-9].
15904641|NCT03613610|Radiation|Radio-frequency ablation of genicular nerves|Ablation of the genicular nerves for pain relief in advanced knee osteoarthritis
15904642|NCT03613597|Drug|etoposide plus lobaplatin|Thoracic intensity modulated radiation therapy (IMRT) + etoposide plus lobaplatin
15904643|NCT03613597|Drug|etoposide plus cisplatin|Thoracic intensity modulated radiation therapy (IMRT) + etoposide plus Cisplatin
15904644|NCT03613584|Drug|Von Willebrand Factor|Bolus and continuous infusion of the Investigational Medicinal Product (IMP) during extracorporeal membrane oxygenation (ECMO)
15904645|NCT03613584|Drug|Saline Solution|Bolus and continuous infusion of the Investigational Medicinal Product (IMP) during extracorporeal membrane oxygenation (ECMO)
15904646|NCT03613571|Drug|ILB|The investigational medicinal product ILB will be given as single short-term s.c. injections in the abdomen, the thigh or the buttock, in that order of priority. Subjects will be observed for at least 3 hours after injection.The IMP is a sterile, colourless to pale yellow solution for subcutaneous injection.
15904647|NCT03613558|Drug|Dexmedetomidine|Dexmedetomidine is an alpha-2 agonist that provides both sedation and analgesia
15904648|NCT03613558|Drug|Placebo|saline solution
15904649|NCT03613545|Procedure|fecal microbiota transplantation|200 mL of prepared fecal microbiota suspension from heathy donors' fresh feces was injected into the colon
15904650|NCT03613545|Procedure|Infusion of sham|Infusion of sham
15904651|NCT03613545|Drug|probiotics, antibiotics or antidepressants|Drugs such as probiotics, antibiotics, antidepressants
15904652|NCT03613532|Drug|Venetoclax|Part 1 and 2: 6-7 total doses depending on dose level assigned
15904653|NCT03613532|Drug|Fludarabine|◦Fludarabine : given once daily for 4 days
15904654|NCT03613532|Drug|Busulfan|◦Busulfan: given twice daily for 4 days
15904655|NCT03613532|Drug|Venetoclax|Part 2: 14 doses for 8-12 cycles depending on dose level assigned
15904656|NCT03613532|Drug|Azacitidine|Part 2: 5 doses for 8-12 cycles depending on dose level assigned
15904657|NCT03613519|Behavioral|SHUTi|A woman assigned to SHUTi receives access to an online program that includes 6 interactive sessions that are designed to be reviewed over a period of 6 to 8 weeks. The online sessions include videos and written material that give information about factors that affect sleep, changes that might help sleep patterns, and how to make those changes. Each session takes about 45 to 60 minutes to complete. During and between sessions, the participant fills out sleep diaries to gather information about daily sleep patterns. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health as well as sleep diaries. Time 1 is just before starting the first session of the SHUTi program. Time 2 is about 9 weeks later and Time 3 is about six months after that. The questionnaires will be used to assess the effect of the online program on the participant's sleep and health.
15904658|NCT03613519|Behavioral|modified SHUTi|A woman assigned to modified SHUTi receives access to an online program that includes 6 interactive sessions that are designed to be reviewed over a period of 6 to 8 weeks. The online sessions include videos and written material that give information about factors that affect sleep, changes that might help sleep patterns, and how to make those changes. Each session takes about 45 to 60 minutes to complete. During and between sessions, the participant fills out sleep diaries to gather information about daily sleep patterns. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health as well as sleep diaries. Time 1 is just before starting the first session of the modified SHUTi program. Time 2 is about 9 weeks later and Time 3 is about six months after that. The questionnaires will be used to assess the effect of the online program on the participant's sleep and health.
15904724|NCT03612960|Drug|Very low nicotine content cigarettes|Very low nicotine content cigarettes
15904725|NCT03612960|Drug|Normal nicotine content cigarettes|Normal nicotine content cigarettes
15904726|NCT03612947|Drug|Bupivacaine +magnesium sulphate|Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine) plus 150 mg of MgSo4
15904970|NCT03610945|Drug|EDP-305|Subjects will receive a single dose of EDP-305 on Day 1 and Day 8
15904659|NCT03613519|Behavioral|Usual care|A woman assigned to usual care receive access to a website that provides detailed information on habits and environments that may help or hinder sleep. The site can be visited as often as desired. At 3 different times, the woman is asked to fill out questionnaires about her sleep and health, as well as sleep diaries to gather information about her daily sleep pattern. Time 1 is just before first logging into the sleep information website. Time 2 is about 9 weeks later and Time 3 is six months after that. The questionnaires will be used to assess the effect of the sleep information program on the participant's sleep and health.
15904660|NCT03613506|Drug|Captopril 12.5 Mg|Taking captopril 12.5mg b.i.d for two months before radiotherapy.
15904661|NCT03613493|Diagnostic Test|HPV self-sampling kit|The HPV self-sampler kit will include the collection swab and the vial for collecting and storing the specimen, and an instructional sheet that visually depicts the steps for self-sampling.
15904662|NCT03613493|Behavioral|Culturally-targeted Fear Appeal Message|Participants will receive culturally-targeted and fear appeal messages in a graphically designed kit.
15904663|NCT03613493|Behavioral|Fear Appeal Message|Participants will receive fear appeal messages (only) in a graphically designed kit.
15904664|NCT03613493|Behavioral|Interview|Participants will be interviewed about experiences using the self-sampling tool (qualitative).
15904665|NCT03613480|Other|Motivational Interviewing|Regular sessions of Motivational Interviewing at 2 weeks and then at monthly intervals for a period of 6 months
15904666|NCT03613467|Procedure|VATS lobectomy|Patients who received lobectomy by video-assisted thoracoscopic surgery
15904667|NCT03613467|Procedure|Thoracotomy lobectomy|Patients who received lobectomy by thoracotomy
15904668|NCT03613454|Device|Splenic artery embolization with vascular embolic coils|Splenic artery embolization with vascular embolic coils
15904669|NCT03613454|Device|Splenic artery embolization with vascular embolic plugs|Splenic artery embolization with vascular embolic plugs
15904670|NCT03613441|Behavioral|Mindful Awareness Practices (MAPs)|Please refer to arm description
15904671|NCT03613428|Drug|Ruxolitinib|Dose escalation up to 80 mg administered orally
15904672|NCT03613428|Drug|Vincristine|1.4 mg/m2 i.v. weekly for 4 weeks
15904673|NCT03613428|Drug|Prednisone|1 mg/kg orally 5 consecutive days per week for 4 weeks.
15904674|NCT03613415|Other|Expansion|non invasive technique to increase thickness of thin ridge
15904675|NCT03613389|Dietary Supplement|oral topical vitamin E|Vitamin E is an antioxidant agent which may limit tissue damage from free oxygen radicals and, thus, may reduce the severity of mucositis during cancer treatments and protect cell membranes from radiation damage (Alterio et al., 2007). It has a very low toxicity and is generally well-tolerated (Geeraert et al., 2015).
15904676|NCT03613376|Other|Class II compression stockings|Patients in this group will use class II compression stocking continuously until next evening and then next 4 days during daytime
15904677|NCT03613350|Diagnostic Test|Pad test|20-minutes pad test and urodynamic study (including uroflowmetry, filling and voiding cystometry, and urethral pressure profile) were conducted to every patient.
15904678|NCT03613337|Other|clinical restenosis|The primary endpoints is clinical restenosis, the investigators will compared the incidence of clinical restenosis by different smoking status.
15904679|NCT03613324|Diagnostic Test|Pad test|20-minutes pad test and urodynamic study including uroflowmetry, filling cystometry and voiding cystometry.
15904680|NCT03613311|Diagnostic Test|Urodynamic study|Urodynamic study: including uroflowmetry, filling cystometry, voiding cystometry, and urethral pressure profile
15904681|NCT03613298|Device|HIFU (Focal One®)|Endometriosic lesion localization and HIFU treatment will be conducted with the Focal One® device. The treatment area will be defined using sonography, pelvic MRI and a transrectal sonography data. Once the pre-defined lesion will be located with Focal One device, succession of HIFU exposure will then be used to treat maximum lesion volume, excluding a security margin of 3 mm with the digestive mucosae.
15904682|NCT03613285|Device|conventional brackets|conventional brackets with MBT prescription was used for orthodontic treatment and root resorption was assessed.
15904683|NCT03613285|Device|smart clip passive self ligating brackets|smart clip passive self ligating brackets with MBT prescription was used for orthodontic treatment and root resorption was assessed.
15904684|NCT03613285|Device|Empower active self ligating brackets|Empower active self ligating brackets with MBT prescription was used for orthodontic treatment and root resorption was assessed.
15904685|NCT03613272|Procedure|Subxiphoid approach extended thymectomy by VATS|Extended thymectomy performed through the subxiphoid-right VATS approach with double elevation of the sternum
15904686|NCT03613272|Procedure|Intercostal approach extended thymectomy by VATS|Extended thymectomy performed through the traditional intercostal VATS approach
15904687|NCT03613259|Drug|Fluorothymidine F-18|Given IV
15904688|NCT03613259|Other|Laboratory Biomarker Analysis|Correlative studies
15904689|NCT03613259|Procedure|Positron Emission Tomography|Undergo fluorothymidine F-18 PET
15904690|NCT03613233|Procedure|Glaucoma surgery|phacoemulsification
15904691|NCT03613207|Other|Dermal pharmacokinetic measurement|"Each subject will have 9 test sites: 4 on the left thigh, 4 on the right thigh, 1 on the arm
~Each test site receives 2 dOFM probes
~Dosing:
~2 test sites: 15 mg/cm² lidocaine and prilocaine cream (2.5% lidocaine, 2.5% prilocaine, ACTAVIS LABORATORIES UT INC, US)
~2 test sites: 10 mg/cm² lidocaine and prilocaine cream (2.5% lidocaine, 2.5% prilocaine, ACTAVIS LABORATORIES UT INC, US)
~2 test sites: 5 mg/cm² lidocaine and prilocaine cream (2.5% lidocaine, 2.5% prilocaine, ACTAVIS LABORATORIES UT INC, US)
~1 test site: 10 mg/cm² Oraqix® gel (2.5% lidocaine, 2.5% prilocaine, Dentsply Pharmaceutical Inc., US/Dentsply DETRY GmbH, Germany)
~2 test sites: untreated test site
~ISF sampling: 24 hours post-dose
~Blood sampling: 7 samples post-dose"
15904692|NCT03613207|Drug|Lidocaine and prilocaine cream|lidocaine and prilocaine cream (2.5% lidocaine, 2.5% prilocaine, ACTAVIS LABORATORIES UT INC, US) will be applied to 6 test sites per subject
15904693|NCT03613207|Drug|Oraqix® gel|Oraqix® gel (2.5% lidocaine, 2.5% prilocaine, Dentsply Pharmaceutical Inc., US/Dentsply DETRY GmbH, Germany) will be applied to 1 test site per subject
15904694|NCT03613207|Device|dOFM-System|Dermal open flow microperfusion system will be used to collect interstitial fluid in order to assess lidocaine/prilocaine concentrations over 24 hours
15904727|NCT03612947|Drug|Bupivacaine only|Ultrasound guided subcostal TAP block will performed on both sides using 20 ml volume (0.25 bupivacaine).
15904696|NCT03613194|Procedure|Sampling|"After inclusion in the study, eligible patients having hepatic metastases and/or péritonéales of a colorectal cancer considered as resecables will have biological and tissue samples.
~The samples will be carried out at the time of the surgical gesture envisaged under general anaesthesia and will concern:
~Tumoral material: primitive tumour (if available), hepatic metastases and/or peritoneal
~Peritoneal liquid
~none tumoral peritoneum
~Portal blood
~Peripheral blood
~Cellulo-lymphatic material The necessary time to carry out the whole of these samples is estimated at 10-15 minutes maximum.
~In the event of complex situations being able to complicate the surgical gesture initially envisaged or to increase by them morbidity, one or more these samples will not be carried out. This decision will be made at the discretion of the investigator."
15904697|NCT03613181|Drug|ANG1005|Investigational drug
15904698|NCT03613181|Drug|Physician's Best Choice|Active Comparator: one of 3 pre-determined choices of therapies: capecitabine or eribulin or high-dose IV methotrexate.
15904699|NCT03613168|Drug|Trastuzumab|Trastuzumab plus gemcitabine/cisplatin
15904700|NCT03613155|Other|Administration of MEOPA as part of the care|Patients should be managed by a SMUR team from Toulouse and benefit from MEOPA administration as part of their management, with a view to analgesia for a painful complaint or prevention of induced pain (for example during mobilization or venous route).
15904701|NCT03613142|Procedure|Double tract anatomosis|After the proximal gastrectomy, the purse-string suture is tied at the esophagus stump, and the anvil head is inserted into the esophagus stump using an anvil clamp. A Roux-en-Y esophagojejunostomy (E-stomy) is performed by intracorporeal anastomosis with a circular stapler, and the jejunal stump is closed with a linear stapler. Next, side-to-side gastrojejunostomy (G-stomy), 15 cm below the E-stomy, is performed using 2 linear staplers. Finally, end-to-side jejunojejunostomy (J-stomy), 20 cm below the G-stomy, is performed by 2 linear staplers.
15904702|NCT03613142|Procedure|Esophagogastrostomy|After the proximal gastrectomy, the purse-string suture is tied at the esophagus stump, and the anvil head is inserted into the esophagus stump using an anvil clamp. Next, end-to-end or side to end esophagogastrostomy is performed with a circular stapler.
15904703|NCT03613129|Drug|CT38|Infusion
15904704|NCT03613116|Dietary Supplement|Vitamin D3|One-half of each diagnostic group will be randomized to treatment with high-dose vitamin D3 or to standard dose Vitamin D
15904705|NCT03613103|Device|Video laryngoscopy|Intubation with videolaryngoscopy with highly curved blade
15904706|NCT03613103|Device|Direct laryngoscopy|Intubation with direct laryngoscopy with macintosh blade
15904707|NCT03613090|Drug|Collagen-hydroxyapatite scaffold (Syn-Oss)|The aim of this study is to add to the existing body of regenerative endodontics research by providing human radiographic evidence for the healing process which occurs after the placement of a FDA-approved collagen-hydroxyapatite scaffold, in the use of a blood clot
15904708|NCT03613090|Drug|Collagen Scaffold (Colla-Plug)|Traditionally, endodontic therapy consisted of removing the infected dental pulp from the canal spaces and replacing it with an artificial substitute called gutta percha. Regenerative endodontic research efforts were originally concentrated upon treatment of the immature necrotic tooth whereby stem cells from the bone near the root end were stimulated to grow onto a blood clot scaffold created within the debrided and disinfected canal space. The hope is that the stem cells would differentiate into cells which could potentially replace the lost pulpal tissues, restoring what was lost due to infection.
15904709|NCT03613077|Procedure|surgical placement of an endosteal implant|Subjects, male or female at least 18 years old, with the need of dental implant therapy and restoration according to the cleared indications for the implant
15904710|NCT03613064|Other|Socially Enhanced Transitional Care Intervention|Components: 1) Standardized social vulnerabilities assessment tool, to be developed and incorporated into admission workflows. 2) Electronic community service referrals to existing community resources (i.e. food banks, shelters, community rehab), via the Dallas IEP or other information technology platform, for material (food, housing) and psychosocial needs (mental health/drug treatment). 3) Community-based cardiovascular self-management interventions, to be developed and piloted in conjunction with #3 - e.g., customized 'heart healthy' food baskets for CHF/IHD; risk factor monitoring (i.e., weight and blood pressure measurement at food banks, shelters, churches, modeled on the barber shop hypertension intervention); and 'heart buddy' support groups for CHF and IHD at community sites.
15904711|NCT03613051|Behavioral|Movement Assessment Battery for children|this test measures manual dexterity , balance , aiming and catching
15904712|NCT03613038|Behavioral|Phonetic complexity effects on speech motor performance|Use of 3D electromagnetic articulography to examine phonetic complexity effects of single word stimuli at the articulatory kinematic level in talkers each with preclinical, mild, and moderate dysarthria, relative to healthy controls.
15904713|NCT03613025|Diagnostic Test|Sampling of non-invasive and/or non-targeted respiratory tract specimens|Sampling of oral fluids, sputa, bronchial aspiration in addition to BAL for the molecular diagnosis of PCP
15904714|NCT03613012|Diagnostic Test|Pain index|Record the patients' EEG and extract pain index before and after pain treatments
15904715|NCT03612999|Device|Dexcom continuous glucose monitor|Continuous glucose monitors (CGMs) record subjects glucose levels
15904716|NCT03612999|Device|Fitbit activity tracker|Activity trackers will record subjects' physical activity, heart rate, and sleep.
15904717|NCT03612999|Behavioral|Subjects record daily activity|Subjects will record their daily activities, either on paper or on a secure texting app.
15904718|NCT03612999|Behavioral|Subjects record psychological state|Subjects will record their psychological state, either on paper or on a secure texting app.
15904719|NCT03612986|Dietary Supplement|SYALOX® 300 Plus|Reduction of pain and improvement of the knee mobility in patients affected by knee osteoarthritis
15904720|NCT03612986|Dietary Supplement|Placebo|Placebo comparator. No chemical effect expected
15904721|NCT03612973|Diagnostic Test|lipid profile|Serum samples will be withdrawn after fasting 12 hours then performed on Siemens Dimension Max: Total cholesterol and triglyceride concentrations will be estimated using enzymatic methods ( Roche Diagnostics, Mannheim, Germany). High density lipoprotein cholesterol will be determined after precipitation with phosphotungstic acid/magnesium chloride. Low density lipoprotein(LDL) cholesterol will be measured directly with a commercially available direct LDL-C assay (LDL-C Plus assay; Roche Diagnostics)
15904722|NCT03612973|Diagnostic Test|fasting insulin|serum samples used for doing the test by ELISA after fasting for 8 h
15904723|NCT03612973|Diagnostic Test|fibro scan|liver stiffness by fibro scan before and after treatment
15904728|NCT03612934|Procedure|Specialist Palliative Care|In the research, Specialist Palliative Care was provided according to the guidelines established by Mid-Western Health Board in a Report of the National Advisory Committee on Palliative Care as well as according to recommendations of Polish Society of Palliative Medicine and Polish National Healthcare Fund. In order to ensure interdisciplinary and integrated palliative care, a team of specialists was appointed. Team members were engaged in the process of treatment of each patient during the time of the study and applied their specialist skills according to the needs of the patients
15904729|NCT03612921|Drug|oral Amantadine sulfate|oral amantadine
15904730|NCT03612921|Drug|i.v Amantadine Sulfate|intra venous amantadine
15904731|NCT03612921|Drug|placebo tablet|placebo tablet
15904732|NCT03612895|Behavioral|Internal Care Coordination|This individual will primarily initiate, guide, and optimize adherence to the care that others deliver, rather than providing direct care his or herself. S/he will call the smoker to conduct a brief assessment of tobacco use and readiness to quit, offer brief counseling and motivational intervention, describe the available pharmacologic and behavioral options, help the smoker to choose among them, and link the smoker to chosen resources. The resources offered will include both internal (health care system based) and external (community based) tobacco cessation resources.
15904733|NCT03612895|Behavioral|External Community Referral|Massachusetts (MA) Helpline services include an assessment of smoking history and readiness to quit, advice to quit, self-help materials and telephone counseling. For smokers who set a quit date in the next 30 days, the Helpline offers up to 5 proactive telephone counseling calls with options for text messaging and web-based resources. It also provides eligible smokers 4 weeks of free nicotine patch or gum mailed to their home.
15904734|NCT03612895|Behavioral|Usual Care|Participants will be given the number to the MA Smokers Helpline and advised to contact their primary care provider for additional assistance in quitting smoking.
15904735|NCT03612882|Other|Online questionnaire|Online questionnaire assessing sedentary behaviour, physical activity, subjective well-being, life satisfaction, depression, anxiety, and demographics
15904736|NCT03612869|Drug|LYS-SAF302|Treatment will involve direct injections of the investigational product into both sides of the brain through image-guided tracks, in a single neurosurgical session.
15904737|NCT03612856|Drug|AB023- Dose 1|Participants will receive a single dose of 0.25 mg/kg AB023.
15904738|NCT03612856|Drug|AB023-Dose 2|Participants will receive a single dose of 0.5 mg/kg AB023.
15904739|NCT03612856|Drug|placebo|Participants will receive a single dose of placebo.
15904740|NCT03612843|Other|Observational dry needle|No intervention provided by the study. Observation of any adverse events that occur surrounding dry needling by a physical therapist.
15904741|NCT03612830|Procedure|Laparoscopy endoscopy cooperated surgery|LECS resects the tumor completely by laparoscopy with the help of the precise positioning and guidance of endoscopy
15904742|NCT03612830|Procedure|Dan Vinchi robot endoscopy cooperated surgery|RECS resects the tumor completely by Dan Vinchi Robot with the help of the precise positioning and guidance of endoscopy
15904743|NCT03612817|Drug|Tafluprost/timolol fixed combination|Evaluation of 24-hour pressure control with tafluprost/timolol given in the evening or morning
15904744|NCT03612804|Behavioral|Unsigned note to provider about cessation medication prescription|For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note and unsigned order for the provider about the recommended medication indicated by VA formulary guidelines.
15904745|NCT03612804|Behavioral|Proactive Telephone Counseling from VA Quitline|Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support.
15904746|NCT03612791|Drug|Atezolizumab|atezolizumab administered IV 1200 mg Q3W, starting one week before EBRT (Week -1) and continued as an adjuvant for a total maximum of 20 cycles.
15904747|NCT03612791|Radiation|Radiotherapy|"Pelvic +/- para-aortic EBRT (IMRT): 45 Gy in 25 fractions over 5 weeks (Weeks 1-5, with simultaneously integrated boosts to macroscopically involved lymph nodes, if any, in order to deliver a total dose of 60 Gy to macroscopic lymph nodes (including the dose delivered by brachytherapy).
~Uterovaginal brachytherapy (Week 7; maximum interval between EBRT and brachytherapy: 14 days). If appropriate and feasible, dose escalation will be assumed, particularly for advanced disease, with the objective to deliver a total dose of 85 Gy (equivalent dose in 2-Gy fractions with α/β=10 Gy) to 80% of the High Risk-Clinical Target Volume (HR-CTV), including 45 Gy through EBRT. The total dose might be lower in case of close proximity to organs at risk (OARs).
~Total duration of RT (including brachytherapy) should be ≤ 55 days."
15904748|NCT03612791|Drug|Cisplatin|"Cisplatin infused 40 mg/m2 (maximum 70 mg) weekly IV during EBRT (Weeks 1-5).
~Not administered: during the interval between EBRT and brachytherapy, or during brachytherapy, or if radiotherapy is interrupted."
15904749|NCT03612778|Behavioral|Plant-based diet|Prescription of a meal plan based on unrefined plant-based foods supported by peer group meetings and dietary counselling. Change from the standard western-type nutritional pattern to a low-fat, unrefined, plant-based nutritional pattern.
15904750|NCT03612778|Behavioral|Mediterranean diet|Prescription of a meal plan based on Mediterranean diet pattern supported by peer group meetings and dietary counselling. Change from the standard western-type nutritional pattern to a Mediterranean nutritional pattern.
15904751|NCT03612765|Behavioral|Push-Pull-Hold Program|Developed based on concepts of motivational interviewing, temporal framing, empowerment. It is tailored to Singaporean patients and includes contextual self-care information and tips.
15904752|NCT03612752|Dietary Supplement|CMI-168|Dietary supplement
15904753|NCT03612752|Other|Placebo|Placebo
15904754|NCT03612739|Biological|NKR-2 CAR-T Cells|"The treatment consists in six consecutive cycles of AZA, administered at days
~1 to 7 of a 28-day cycle. Patients will be treated with 8 injections of NKR-2 at day 9 and 23 of AZA cycles 2-3-4 and 5."
15904755|NCT03612713|Drug|Oxycodone Medication First|Participants will be given 15mg oxycodone one hour before fMRI scan. After at least 1 week wash out participants will be given placebo one hour before fMRI scan.
15904756|NCT03612713|Drug|Placebo First|Participants will be given placebo one hour before fMRI scan. After at least 1 week wash out participants will be given 15mg oxycodone one hour before fMRI scan.
15904971|NCT03610932|Dietary Supplement|Vitamin C|Taken as 3 500mg capsules.
15904757|NCT03612700|Other|CPFA-rich foods|Daily consumption of Grana Padano cheese (50 g) and whole milk (250 mL) for 3 weeks.
15904758|NCT03612687|Device|Minimally invasive hemodynamic monitoring|Use of advanced minimally invasive hemodynamic monitoring with PreSep™ Central Venous Oximetry Catheter, Vigileo™ monitor, and FloTrac™ sensor for perioperative fluid management
15904759|NCT03612674|Procedure|Standard colonoscopy|Current standard of care colonoscopy.
15904760|NCT03612674|Device|ARC Endocuff Vision|Subjects randomized to undergo a colonoscopy procedure with ARC Endocuff Vision will have this device placed on the top of the colonoscope used during their procedure.
15904761|NCT03612661|Behavioral|Group Intervention|Participants in the group intervention will attend eight weekly, 90-minute sessions involving group activities and discussions. They will complete homework between sessions to reinforce learning. The intervention focuses on cultivating attunement to bodily sensations and fostering self-compassion to improve physical and mental health.
15904762|NCT03612661|Behavioral|Guided Self-Help|Participants in the GSH condition will follow the intuitive eating content through self-guided study, with eight weekly scheduled phone calls with an interventionist (~20 minutes each). Interventionists will review homework assignments, answer questions, and reinforce adherence. The intervention materials are the same as the group and also focus on cultivating attunement to bodily sensations and fostering self-compassion to improve physical and mental health.
15904763|NCT03612648|Radiation|Three Fraction Accelerated Partial Breast Irradiation|"TRI-APBI simulation must take place no more than 8 weeks from final definitive breast surgery
~Machines that could be used include: SAVI applicator, The ViewRay System for Radiation Therapy, The ViewRay (MRIdian) Linac System, Halcyon, True Beam, True Beam STx, Edge Radiotherapy Delivery System"
15904764|NCT03612648|Procedure|Partial mastectomy|-Standard of Care
15904765|NCT03612635|Device|Implantation of a cardiac implantable electronic device|All patients enrolled in the registry underwent cardiac implantable electronic device implantation
15904766|NCT03612622|Other|transcranial magnetic stimulation|Intermittent Theta-Burst Transcranial Magnetic Stimulation
15904767|NCT03612609|Biological|blood, urine and semen sample|Men will give semen, urine and blood specimens 7 days after the beginning of clinical signs and 15, 30, 60 and 90 days after. Dengue virus RNA being diagnosed with blood and/or urine sample positive for dengue virus RNA. Dengue virus RNA will be detected in seminal plasma, native semen cells and processed spermatozoa.
15904768|NCT03612596|Behavioral|Narrative visualization|Participants use narrative visualization procedures to connect their step data to important events or feelings that occurred at the same time, then reflect on their behavior
15904769|NCT03612596|Behavioral|Standard self-regulation|Participants self-monitor steps using a wearable device, app, and a hand-written step log
15904770|NCT03612583|Procedure|Lung- and Diaphragm-Protective Ventilation|Ventilation and sedation will be progressively modified according to the LDPV algorithm to achieve targets. Patients will be crossed-over to the opposite PEEP strategy. LDPV titration will then be repeated to achieve LDPV targets. After establishing a combination of ventilation and sedation settings at which LDPV targets are achieved, the targets will be maintained over a 24-hour period.
15904771|NCT03612570|Device|Nano-Pulse Stimulation Device|NPS utilizes a timed series of low energy, high voltage nanosecond (billionth of a second) pulses which are applied directly to targeted tissue using small microneedles. NPS energy induces cell signaling and the activation of cellular pathways by creating transient nanopores in cellular membranes and organelles and initiate regulated cell death.
15904772|NCT03612557|Drug|penicillin G benzathine|2.4 million units (IM) of benzathine benzylpenicillin
15904773|NCT03612544|Other|ENDS (Vaporizer/e-cig) and smoking cessation counseling|Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit.
15904774|NCT03612544|Other|Smoking cessation counseling|Participants in the control group will receive smoking cessation counseling only. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit.
15904775|NCT03612531|Procedure|Manual Therapy|Receive manual therapy
15904776|NCT03612518|Behavioral|Text and Voice Messages|Participants in this study arm will periodically receive information regarding antenatal- and postnatal care and family planning services through text and voice messages from the fifth gestational month until the post-partum period of 42 days.
15904777|NCT03612518|Behavioral|Interactive Phone Call|Participants in this study arm will receive information regarding antenatal- and postnatal care and family planning services through periodic interactive phone calls from the fifth gestational month until the post-partum period.
15904778|NCT03612505|Behavioral|Mother groups using principles of UNICEF/World Health Organization's Care for Child Development|"The intervention is expected to occur every two weeks for a total of ten sessions. On the study day, the child- caregiver dyads randomised to intervention group will be shown to the study room. Each intervention session will be estimated to last 90 minutes allocated as follows: 6
~Introduction (10 minutes)
~Lesson on *Early Childhood Development* topic (20 minutes)
~Discussions on strengthens in caregiving around this topic and areas for improvement (30 minutes)
~Observe caretakers one-on-one in play role with the child (25 minutes)
~Wrap up/Re-cap (5 minutes) Early Childhood development topics that will be covered include per session are: i) Importance of early childhood development ii) Showing love and building trust iii) Awareness of child's well-being iv) Consistency and daily routines v) Discipline and correction vi) consistency and daily routines vii) Nutrition and cleanliness Viii) Importance of play iX) Dealing with life stresses X) Planning for the future"
15904779|NCT03612492|Drug|Esmolol|Esmolol group (EG) will receive a bolus of esmolol 1.5mg / kg in 10 min following by continuous infusion at a rate of 0.1mg / kg / min.
15904780|NCT03612492|Drug|Lidocaine|Lidocaine (LG) group will received lidocaine bolus of 1.5mg / kg in 10 min following by continuous infusion at a rate of 1.5mg / kg / h.
15904781|NCT03612479|Behavioral|KIDFIT Healthy|The KIDFIT Healthy intervention promotes the DASH diet, physical activity, limited screen time, and adequate sleep, through a combination of traditional in-person and electronic participant contacts. See NCT03405246 for details.
15904782|NCT03612479|Behavioral|KIDFIT Safe|The KIDFIT Safe active control provides electronic material about safe home environments and activities (e.g., sun screen, choking hazards, pet safety) for children. See NCT03405246 for details.
15904783|NCT03612466|Drug|153Sm-DOTMP|For Levels 1- 3, the Day 1 dosages will be the same (0.5 millicurie (mCi)/kg 153Sm-DOTMP) for all levels but the Day 8 dosages will be 0.5, 1.0 and 3.0 mCi/kg respectively. For Levels 4, 5 & 6, the Day 1 dosages will be the same (0.5 mCi/kg 153Sm-DOTMP) for all levels but the Day 8 dosages will be 3, 6, then 10 mCi/kg 153Sm-DOTMP respectively.
15904784|NCT03612466|Radiation|External beam radiotherapy.|The amount of radiation will be determined based on how much radiation was delivered to each tumor by the 153Sm-DOTMP, and will be targeted to 70 Gray (Gy)
15904785|NCT03612466|Drug|Calcium Carbonate|Calcium carbonate will be given to participants as prophylaxis against hypocalcemia..
15904786|NCT03612466|Drug|Mozobil|Participants who require stem cell collection will be given Mozobil to help mobilize hematopoietic stem cells into the circulation for collection.
15904787|NCT03612466|Drug|Neupogen Injectable Product|Participants who require stem cell collection will be given Neupogen to help mobilize hematopoietic stem cells into the circulation for collection.
15904788|NCT03612453|Other|ENDS (vaporizer/e-cig) and smoking cessation counseling|Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 6-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6 months, participants will be asked to come to a final clinical visit.
15904789|NCT03612453|Other|Smoking cessation counseling|Participants in the control group will receive smoking cessation counseling only. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 6-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6 months, participants will be asked to come to a final clinical visit.
15904790|NCT03612440|Drug|dexmedetomidine|receive a loading infusion of dexmedetomidine (1ug/kg)for 20min follow by a maintenance infusion (0.4ug/kg/h) continued until the end of the surgery
15904791|NCT03612440|Other|normal saline|receive matching placebo (equal volum of normal saline)
15904792|NCT03612427|Dietary Supplement|S. Cholesterol S. Triglyceride|S. Cholesterol S. Triglycerides
15904793|NCT03612414|Dietary Supplement|Aqualief|Three tablets/day
15904794|NCT03612414|Dietary Supplement|Placebo|Three tablets/day
15904795|NCT03612401|Drug|Mirabegron|Beta-3 adenoreceptor agonist
15904796|NCT03612388|Procedure|use of a cardioplegic formula in isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation|use of a novel cardioplegic formula with MPS® (Myocardial protection system) versus Cardioplexol ® (colloid solution with Procaine, magnesium and potassium) in isolated CABG (coronary artery bypass grafting) using MiECC (Minimal extracorporeal circulation system).
15904797|NCT03612375|Other|ENDS (vaporizer/e-cig) and smoking cessation counseling|Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit.
15904798|NCT03612375|Other|smoking cessation counseling|Participants in the control group will receive smoking cessation counseling only. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit.
15904799|NCT03612362|Device|"Improved Injera Baking Biomass Stove"|"Replacing of the Ethiopian traditional Injera baking biomass stove with improved baking biomass stove, the well-known commercially distributed type of baking stove in Ethiopia, will be the intervention for this study. Control HHs will continue to use the traditional baking biomass stove. Concerning intervention duration, since the life span of the Ethiopian improved baking stove is about 5 years, the length of the intervention period will be one year to account for seasonal factors that have major effect on both ARI incidence & HAP level in Ethiopia as well as to maintain a balance between achieving a sufficiently long follow-up period for outcome measurements & suitably short follow-up period to decrease attrition."
15904800|NCT03612349|Behavioral|Experimental Tobacco Marketplace Task|Participants will select tobacco products from an Experimental Online Tobacco Marketplace under both marketplace conditions.
15904801|NCT03612336|Other|ENDS (vaporizer/e-cig) and smoking cessation counseling|Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit.
15904802|NCT03612336|Other|Smoking cessation counseling|Participants in the control group will receive smoking cessation counseling only. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit.
15904803|NCT03612323|Drug|Intra-ligamentary Piroxicam|Piroxicam is a long-acting potent analgesic non selective oxicams derivative, has a half-life of 50 hrs in the plasma.The onset of action of oral piroxicam is 2-4 hrs, but it is anticipated that injectable piroxicam could produce more rapid onset of action. It could favourably overcome the intense pain up to 48 hrs following the treatment
15904804|NCT03612323|Drug|Intra-ligamentary Articaine|Articaine is a local anesthetic agent , has been reported to be an effective anesthetic in controlling pain during root canal treatment
15904805|NCT03612310|Procedure|Skin biopsy/Urine Collection/Blood Sample Collection|"Participant will meet clinician in a suitable local clinical setting, in select circumstances the clinician may attend the participants home. Clinician will collect a 5-7mm section of skin, the area may be numbed beforehand and stitches may be used to close the wound when required. The wound will be dressed if deemed necessary by medical professional.
~Participant will meet clinician in a suitable local clinical setting, in select circumstances the clinician may attend the participants home. The clinician or phlebotomost will use a disposable needle to remove a blood sample (normally 50ml but could be up to 320ml for adults).
~Participant will meet clinician in a suitable local clinical setting, in select circumstances the clinician may attend the participants home. The clinician or other nominated member of the clinical team will provide a sterile urine collection vessel and direct the volunteer to a suitable private toilet area to provide the sample."
15904806|NCT03612297|Diagnostic Test|Selective reporting of Antibiotic Susceptibility Tests|Selective reporting of antibiotic susceptibility tests for all E. coli identified in urine cultures of adults: results of susceptibility are reported back to the practitioner only for few (n=5-6) antibiotics, those that should be used in first line according to guidelines. Susceptibility results not mentioned in the selective reporting of AST are available at the practitioners' request to the microbiologist. Data used to determine which antibiotic to report for UTIs are the isolated microorganism, the patient age and gender, and antibiotics recommended in national guidelines. As guidelines for UTIs treatment differ by gender, two algorithms have been developed and pilot-tested by three GPs, one microbiologist and two infectious disease physicians.
15904807|NCT03612284|Device|contact lens insertion solution|"This contact lens solution is being tested for safety and comfort and is not an intervention. Subjects will have their scleral contact lenses filled with the test saline in the examination room and applied to their eyes. They will be monitored for symptoms and will be examined. Six to 8 hours later or whenever their lens clouding typically occurs they will return for further assessment and dispensing of solution if acceptable. subjects will use the solution for 5-9 days and return for a follow-up appointment. At each visit, subjects will complete an OSDI questionnaire and a Current Symptoms questionnaire."
15904808|NCT03612271|Behavioral|mGlide|BP will be automatically transmitted to the providers. The transmitted BP will be used for adjustment of anti-HTN medications as it occurs in clinical practice.
15904809|NCT03612258|Diagnostic Test|Functional Magnetic Resonance Imaging|Functional Magnetic Resonance Imaging scans will be completed to assess neural responses to painful, non-painful sensory, and emotion-eliciting stimuli.
15904810|NCT03612232|Drug|Cabozantinib-s-malate|oral cabozantinib-S-malate 60 mg as a daily single oral dose continuously
15904811|NCT03612219|Drug|Apatinib mesylate tablet|Adjuvant treatment by apatinib mesylate tablet to local advanced nasopharyngeal carcinoma after IMRT with concurrent chemotherapy.the dose of apatinib mesylate tablet was 250 mg,orally,qd,28 days for an observation period,six cycles.
15904812|NCT03612219|Radiation|Intensity-modulated radiation therapy (IMRT)|Intensity-modulated radiation therapy (IMRT):GTVnx 69.69Gy, GTVnd 60-68Gy, PTV1 59.4Gy and PTV2 54Gy in 33 fractions, 5 days/week.
15904813|NCT03612219|Drug|Cisplatin|Concurrent chemotherapy: patients received intravenous cisplatin 80mg/m2(D1-3), 3-week chemotherapy for 3 cycles.
15904814|NCT03612180|Drug|Metoprolol Succinate|Pharmacokinetics
15904815|NCT03612167|Behavioral|cognitive intervention|a 12 consecutive 90-minute weekly cognitive groups that included cognitive training and rehabilitation, with activity-based cognitive exercises and discussions with a focus on applications of cognitive strategies in daily lives.
15904816|NCT03612167|Behavioral|nutritional group|12 consecutive 90-minute weekly nutritional groups that included nutrition classes (lecture and discussion).
15904817|NCT03612154|Drug|Lorlatinib|Subjects will be treated with lorlatinib 100mg PO daily. A cycle will be defined as 28-days for the convenience of analysis.
15904818|NCT03612128|Other|control group|Children continued their traditional physiotherapy including upper limb exercises in three times a week for 8 week.
15904819|NCT03612128|Other|intervention group|Participants allocated to the experimental group completed three times a week, 8-week mirror therapy in addition to traditional physiotherapy . This protocol consisted of mirror therapy with a mirror box.
15904820|NCT03612115|Device|Neuromuscular electrical stimulation|"Neuromuscular electrical stimulation to the bilateral deltoid and quadriceps femoris muscles with 50 Hz for 3 days/week, 8 weeks.
~Device name: Four-channel Wireless Professional (DJO United Kingdom Ltd., Chattanooga, France)"
15904821|NCT03612102|Behavioral|Intensive Group Behavioral Treatment (IGBT)|IGBT is a 5-day intensive treatment program, where cognitive behavioral therapy is provided to children and their parents delivered over 6-8 hours per day over the course of 5 days.
15904822|NCT03612076|Other|Global cost of management of PJI|estimation of the global cost to manage PJI with 2-step exchange over 3 years
15904823|NCT03612063|Device|Fitbit Iconic HR and Garmin Vivosmart HR|"During testing, participants will wear two different wrist-worn heart rate monitors, the Polar H7 heart rate sensor, and will be connected to an ECG machine. Participants will be asked to perform a series of movements on a treadmill. Heart rate will be assessed under the following conditions:
~At rest
~4 mph
~5 mph
~6 mph
~7 mph
~8 mph
~9 mph
~Post-exercise 1 minute
~Post exercise 2 minutes"
15904824|NCT03612063|Device|Fitbit Iconic HR and TomTom Spark 3|"During testing, participants will wear two different wrist-worn heart rate monitors, the Polar H7 heart rate sensor, and will be connected to an ECG machine. Participants will be asked to perform a series of movements on a treadmill. Heart rate will be assessed under the following conditions:
~At rest
~4 mph
~5 mph
~6 mph
~7 mph
~8 mph
~9 mph
~Post-exercise 1 minute
~Post exercise 2 minutes"
15904893|NCT03611556|Biological|oleclumab|Subjects will receive oleclumab with or without durvalumab and in combination with chemotherapy viz. gemcitabine and nab-paclitaxel or mFOLFOX (5FU, leucovorin and oxaliplatin) until disease progression
15904972|NCT03610932|Other|Placebo|Taken as 3 500mg capsules.
15904825|NCT03612063|Device|Garmin Vivosmart HR and TomTom Spark 3|"During testing, participants will wear two different wrist-worn heart rate monitors, the Polar H7 heart rate sensor, and will be connected to an ECG machine. Participants will be asked to perform a series of movements on a treadmill. Heart rate will be assessed under the following conditions:
~At rest
~4 mph
~5 mph
~6 mph
~7 mph
~8 mph
~9 mph
~Post-exercise 1 minute
~Post exercise 2 minutes"
15904826|NCT03612063|Device|Fitbit Iconic HR and Apple Watch III|"During testing, participants will wear two different wrist-worn heart rate monitors, the Polar H7 heart rate sensor, and will be connected to an ECG machine. Participants will be asked to perform a series of movements on a treadmill. Heart rate will be assessed under the following conditions:
~At rest
~4 mph
~5 mph
~6 mph
~7 mph
~8 mph
~9 mph
~Post-exercise 1 minute
~Post exercise 2 minutes"
15904827|NCT03612063|Device|Apple Watch III and Garmin Vivosmart HR|"During testing, participants will wear two different wrist-worn heart rate monitors, the Polar H7 heart rate sensor, and will be connected to an ECG machine. Participants will be asked to perform a series of movements on a treadmill. Heart rate will be assessed under the following conditions:
~At rest
~4 mph
~5 mph
~6 mph
~7 mph
~8 mph
~9 mph
~Post-exercise 1 minute
~Post exercise 2 minutes"
15904828|NCT03612063|Device|Apple Watch III and TomTom Spark 3|"During testing, participants will wear two different wrist-worn heart rate monitors, the Polar H7 heart rate sensor, and will be connected to an ECG machine. Participants will be asked to perform a series of movements on a treadmill. Heart rate will be assessed under the following conditions:
~At rest
~4 mph
~5 mph
~6 mph
~7 mph
~8 mph
~9 mph
~Post-exercise 1 minute
~Post exercise 2 minutes"
15904829|NCT03612050|Behavioral|Meaning Centered Psychotherapy|"Manualized, 3-session existential psychotherapy (30-45 minutes/session) with an optional 4th booster session. Content focuses on enhancing patients sense of meaning and purpose in life."
15904830|NCT03612037|Dietary Supplement|alpha lipoic acid|600 mg/day oral dose of alpha lipoic acid
15904831|NCT03612037|Dietary Supplement|Cellulose|600mg/day oral dose of placebo cellulose
15904832|NCT03612024|Behavioral|questionnaire|a standardized questionnaire was sent to all participants
15904833|NCT03612011|Other|Onco-Repair/ Placebo|Cream must be applied twice a day, in the morning and evening, on the hands and feet (palmo-plantar areas and interdigital spaces included) previously cleaned with Atoderm Intensive Foaming Gel, chosen as a standardized hygiene product.
15904834|NCT03611998|Behavioral|Occupation-based programming|Group sessions consisted of specific tasks performed to completion that emphasized skills such as problem-solving, decision-making, frustration tolerance, appropriate pacing, attention, inquiring, sequencing, gathering, organizing, adjusting, responding, enduring, initiating and cooperating. Examples of tasks included projects that the women were specifically interested in learning such as jewelry making, holiday decorations, clay work and other home décor projects. Investigators observed these and other behaviors during the group sessions, and scored individuals using the OTTOS instrument.
15904835|NCT03611985|Drug|Epidiferphane|"During the phase I portion of the study, subjects will be assigned to take either two (half target dose) or four (full target dose) Epidiferphane tablets orally three times daily following a 3 + 3 design. Three subjects will be sequentially enrolled at each of the 2 dose levels (beginning with the half target dose) until at least one dose-limiting toxicity (DLT) occurs. Dosing escalation will be stopped if two or more DLTs occur at either dose level. The maximum tolerated dose will be one dose level lower than the dose level at which 2 or more DLTs occur. Dose escalation will occur separately for each of the two taxane regimens (weekly paclitaxel or docetaxel every 3 weeks).
~All subjects in the phase IIa portion of the study will receive the maximum tolerated dose determined in the phase I portion of the study for their taxane regimen.
~Subjects in both portions of the study will receive treatment with Epidiferphane for a maximum of three months."
15904836|NCT03611985|Drug|Taxane Chemotherapy|All subjects on both phases of the study will be concurrently treated with a taxane regimen containing either paclitaxel given weekly or docetaxel given every 3 weeks. The choice of taxane regimen will be determined by the treating physician prior to consenting to participate in this trial.
15904837|NCT03611972|Dietary Supplement|Sugar-sweetened beverage|Sugar-sweetened koolaid-flavored water.
15904838|NCT03611959|Other|Non Applicable|
15904839|NCT03611946|Biological|rZIKV/D4Δ30-713 (Administered at a dose of 10^3 plaque-forming units (PFUs) by subcutaneous injection)|Administered at a dose of 10^3 plaque-forming units (PFUs) by subcutaneous injection
15904840|NCT03611946|Biological|Placebo|Administered by subcutaneous injection.
15904841|NCT03611946|Biological|rZIKV/D4Δ30-713 (Administered at a dose of using 10^4 plaque-forming units (PFUs) by subcutaneous injection).|Administered at a dose of using 10^4 plaque-forming units (PFUs) by subcutaneous injection.
15904842|NCT03611933|Other|position change applied at different times|Time 1 - in the first fifth minute after the procedure supine position in which the HOB was elevated 15° Time 2 - in the first hour low fowler's position were given in which the HOB was elevated 15-30° Time 3 - in the third hour semi high fowler's position were given in which the HOB was elevated 30-45° Time 4 - in the fourth hour left or right lateral position were given in which the HOB was elevated 15° Time 5 - in the fifth hour low fowler's position were given in which the HOB was elevated 15-30° Time 6 - in the sixth hour standard fowler's position were given in which the HOB was elevated 45-60°
15904843|NCT03611920|Procedure|Tetracycline|Teeth were soaked in topical tetracycline 5% for 5 minutes before replantation
15904844|NCT03611920|Procedure|Dexamethasone|Teeth were soaked in topical dexamethasone (60μ ml-1) for 20 minutes before replantation
15904845|NCT03611907|Device|"Oocyte retrieval with only aspiration system SL1(Cook® Single Lumen)"|In this intervention a 17-Gauge needle is used to aspirate the follicles
15904846|NCT03611907|Device|"Oocyte retrieval with aspiration and flushing system DL1 (Cook® EchoTip® Double Lumen)"|In this intervention a 17-Gauge needle is used to aspirate follicle, and consequently a 1 mL flush is injected and aspirated twice for each punctured follicle
15904847|NCT03611894|Other|radiological comparison|comparison between clinical and radiological characteristics
15904848|NCT03611881|Behavioral|Counseling|4 or 8 weeks of behavioral counseling support to promote smoking cessation.
15904849|NCT03611881|Drug|Nicotine patch|2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.
15904850|NCT03611881|Behavioral|Community Resource|Counselor-facilitated referral to a community-based program to address social needs.
15904928|NCT03611322|Device|PDS290 pen-injector|PDS290 pen-injector will be used for administration of semaglutide
15904851|NCT03611868|Drug|APG-115+Pembrolizumab|dose escalation of APG-115 in combination with label dose of pembrolizumab, Four dose levels of APG-115 will be tested: 50, 100, 150, and 200 mg. APG-115 will be administrated orally every other day (QOD) for consecutive 2 weeks (ie. dosed at Day 1, 3, 5, 7, 9, 11, and 13), with one week dosing off as 3-weeks a cycle. Pembrolizumab is administrated following FDA approved label dose, i.e., 200 mg intravenous infusion at Day 1 of every 3 weeks as a cycle.
15904852|NCT03611855|Device|BCI Rehabilitation|Patients use electroencephalography (EEG) signals to control a motorized glove worn on their affected hand. The glove moves the patient's hand according to the type of signal detected (Rest vs Motor Imagery).
15904853|NCT03611855|Other|Range of Motion Therapy|Patients repeatedly move or stretch the joints and muscles of their affected limb, either by actively moving the limb or assisting the limb with no active motion.
15904854|NCT03611842|Other|preservation of mucosal otitis media|Suction of the middle ear fluid and conservation of the fluid to be collected instead of thrown away into children Healthy eardrum and Atrophic eardrum
15904855|NCT03611829|Behavioral|ACT Intervention|
15904856|NCT03611829|Behavioral|Standard Care|
15904857|NCT03611816|Biological|Blood taken|Collection of clinical data
15904858|NCT03611816|Genetic|Blood taken|Collection of DNA
15904859|NCT03611816|Genetic|Blood taken|Collection of plasma
15904860|NCT03611803|Device|Physiotherapy + Robotic-device|Daily use of an exoskeleton (robotic-device) on 5 successive days as well as daily physiotherapy sessions
15904861|NCT03611803|Other|Physiotherapy only|Participants will engage in daily physiotherapy sessions (without the exoskeleton) and/or home-based sit-to-stand exercises
15904862|NCT03611790|Device|NeVa VS|mechanical dilatation
15904863|NCT03611777|Drug|Inhaled corticosteroid|Drug
15904864|NCT03611764|Behavioral|Body Scan|-All efforts will be made to normalize their experience: for example, the desire to open their eyes, thinking about other things, wanting to move around - these are all normal and participants will be encouraged to become interested in and curious about, and to allow these natural tendencies
15904865|NCT03611764|Other|Rotterdam Symptom Checklist|"39 Likert-scale items, including physical and psychological symptoms (30 questions), daily function (8 questions), and overall valuation of life (one question)
~For the 30 questions pertaining to symptoms, the four-item Likert scale ranges from 'not at all=1' to 'very much=4'; the higher the total score, the greater the score, the higher the level of distress. The single question pertaining to overall valuation of life asks participants to circle one of the seven items, ranked from extremely poor to excellent"
15904866|NCT03611764|Other|Practice Logs|-Describe frequency of the Zen Den
15904867|NCT03611751|Drug|BMS-986165|Specified dose on specified days
15904868|NCT03611751|Other|Placebo|Specified dose on specified days
15904869|NCT03611751|Drug|Apremilast|Specified dose on specified days
15904870|NCT03611738|Drug|Ceritinib|Ceritinib daily by mouth (PO) with food, according to the dosage schedule outlined in the treatment arm.
15904871|NCT03611738|Drug|Docetaxel|Docetaxel intravenously (IV) every 3 weeks, according to the dosage schedule outlined in the treatment arm.
15904872|NCT03611725|Procedure|Distal radial artery|The distal radial artery will be punctured with a puncture needle. Then, coronary angiography and percutaneous coronary intervention will be performed.
15904873|NCT03611725|Procedure|Radial artery|The radial artery will be punctured with a puncture needle. Then, coronary angiography and percutaneous coronary intervention will be performed.
15904874|NCT03611712|Drug|Astragalus Polysaccharides 500 mg|PG2 Lyo. Injection 500 mg will be given on 1 week before CCRT (Week 1, PG2 Lyo. Injection 500 mg, b.i.w), during CCRT (Week 2-6, PG2 Lyo. Injection 500 mg, t.i.w for 5 weeks), and after CCRT (Week 7-8, PG2 Lyo. Injection 500 mg, t.i.w for 2 weeks)
15904875|NCT03611699|Drug|Umeclidinium / Vilanterol Dry Powder Inhaler|umeclidinium/vilanterol dry powder inhaler
15904876|NCT03611699|Drug|Placebo|Placebo inhaler
15904877|NCT03611686|Drug|Local chemotherapy|Local chemotherapy will be administrated according to local recommendation
15904878|NCT03611673|Other|Smell Test|Oils are used for each of the different scents. Each scent will be put on an aromatherapy inhaling stick.
15904879|NCT03611660|Behavioral|Traditional Healthy Lifestyle Program|Twice weekly meetings that focus on nutrition and exercise for 12 weeks.
15904880|NCT03611660|Behavioral|Mindfulness Meditation Instruction|Participants receive six mindfulness sessions.
15904881|NCT03611647|Dietary Supplement|Probiotic|Probiotic dietary supplement containing a mixture of Lactobacillus and Bifidobacterium species, taken by mouth once daily for 4-6 weeks.
15904882|NCT03611647|Dietary Supplement|Placebo|Placebo, taken by mouth once daily for 4-6 weeks.
15904883|NCT03611634|Other|BIOLOGICAL COLLECTION FROM THE GUT MICROBIOTE|collection of saddles
15904884|NCT03611621|Drug|Imlifidase|This is a five year, long-term follow up, observational study. The study will primarily determine the time of graft survival in subjects who have received imlifidase prior to kidney transplantation. Subjects who have participated, or are currently participating, in the imlifidase kidney transplantation studies (called feeder studies) 13-HMedIdeS-02, 13-HMedIdeS-03, 14-HMedIdeS- 04 and 15-HMedIdeS-06 will be included. The subjects will attend 4 follow up visits, 1, 2, 3 and 5 years after imlifidase administration.
15904885|NCT03611608|Drug|LY3316531|Administered IV
15904886|NCT03611608|Drug|Placebo|Administered IV
15904887|NCT03611595|Drug|Cabozantinib|Cabozantinib will be given orally once every day with cycles repeated every 4 weeks (28 days, +/- 3 days), with no rest periods between cycles
15904888|NCT03611595|Drug|13-cis-retinoic acid|13-cis-retinoic acid at 80mg/m2/dose twice daily for two consecutive weeks (14 days) out of every four weeks (28 days, +/- 3 days).
15904889|NCT03611582|Drug|Semaglutide|Subcutaneous (s.c., under the skin) injections of semaglutide once weekly at escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks.
15904890|NCT03611582|Drug|Placebo (semaglutide)|S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg/week, 1.7 mg/week, 2.4 mg/week). The dose will be escalated to next level every 4 weeks.
15904891|NCT03611569|Drug|Lu AF82422|Lu AF82422 - concentrate for solution for infusion; vials containing 50mg/ml, single dose
15904892|NCT03611569|Drug|Placebo|placebo - concentrate for solution for infusion, single dose
15904894|NCT03611556|Biological|durvalumab|Subjects will receive durvalumab with oleclumab and in combination with chemotherapy viz. gemcitabine and nab-paclitaxel or mFOLFOX (5FU, leucovorin and oxaliplatin) until disease progression
15904895|NCT03611556|Combination Product|gemcitabine|Subjects will receive gemcitabine in combination with nab-paclitaxel and with or without oleclumab and/or durvalumab until disease progression
15904896|NCT03611556|Combination Product|nab-paclitaxel|Subjects will receive nab-paclitaxel in combination with gemcitabine and with or without oleclumab and/or durvalumab until disease progression
15904897|NCT03611556|Combination Product|oxaliplatin|Subjects will receive oxaliplatin (as part of modified FOLFOX) in combination with or without oleclumab and/or durvalumab until disease progression
15904898|NCT03611556|Combination Product|leucovorin|Subjects will receive leucovorin (as part of modified FOLFOX) in combination with or without oleclumab and/or durvalumab until disease progression
15904899|NCT03611556|Combination Product|5-FU|Subjects will receive a bolus of 5-FU followed by continuous 5-FU infusion (as part of modified FOLFOX) in combination with or without oleclumab and/or durvalumab until disease progression
15904900|NCT03611543|Device|New investigational curved paddle|X-ray imaging of breast tissue
15904901|NCT03611530|Device|Coqun® ophthalmic solution|Prostaglandin analogue (PGA) monotherapy + Coqun® ophthalmic solution
15904902|NCT03611530|Other|Placebo ophthalmic solution|Prostaglandin analogue (PGA) monotherapy + Placebo ophthalmic solution
15904903|NCT03611517|Behavioral|Sexual rehabilitation programme|The intervention consists of 4 patient/couple sessions (each max. 60 minutes) scheduled at 1, 3, 6 and 12 months post-RT. Patients treated with RTBT have an additional session 2 months post RT. If preferred, one extra session of 30 minutes can be scheduled between 6 and 12 months after RT. The intervention includes (1) education on the specific cancer diagnosis and treatment, (2) education on the importance of regular dilation for prevention of vaginal stenosis (if indicated), (3) discussing and resolving potential fears and experienced barriers to performing vaginal dilation (if indicated) and sexual activity,(4) promoting couples' mutual coping and support processes and (5) specific sexual therapy techniques to address sexual and body image concerns.
15904904|NCT03611504|Device|Hemospray®|Hemospray® application
15904905|NCT03611491|Device|Princess FILLER Lidocaine|Princess FILLER Lidocaine injection up to 10 ml given to the patients at baseline time point. After 2 week a touch up is given in case to be consider necessary.
15904906|NCT03611478|Dietary Supplement|Probiotic formulation|Probiotic capsule
15904907|NCT03611478|Dietary Supplement|Placebo|Placebo capsule identical in taste and appearance to probiotic capsule
15904908|NCT03611465|Other|Pace-mapping|Acquire pace-mapping on three distinct populations to better understand the influence of heart disease on electrical conduction.
15904909|NCT03611465|Other|Standard pace-mapping examination|Acquire pace-mapping on three distinct populations to better understand the influence of heart disease on electrical conduction.
15904910|NCT03611452|Procedure|Episiotomy|repair of perineal muscles and skin
15904911|NCT03611439|Dietary Supplement|ReBuilder|8-component botanical dietary supplement
15904912|NCT03611439|Dietary Supplement|Placebo|Inactive Placebo Capsule
15904913|NCT03611426|Drug|rhThrombin ( Topical )|Active Substance
15904914|NCT03611426|Drug|placebo|saline solution
15904915|NCT03611413|Procedure|ERAS care|ERAS PROTOCOL
15904916|NCT03611400|Dietary Supplement|Probiotic|This probiotic is commercially available and contains L. helveticus R0052 (0.2 x 10^9 CFU/capsule) and L. rhamnosus R0011 (3.8 x 10^9 CFU/capsule) as active ingredients and ascorbic acid, hypromellose, magnesium stearate, saccharose, potato starch, titanium dioxide, and maltodextrin as excipients.
15904917|NCT03611400|Dietary Supplement|Placebo|The placebo contains ascorbic acid, hypromellose, magnesium stearate, saccharose, potato starch, titanium dioxide and maltodextrin.
15904918|NCT03611387|Device|CASIA 2 OCT|Using CASIA 2 OCT to assess the anterior chamber angle of the eye in the glaucomatous patients withconventional imaging methods
15904919|NCT03611374|Procedure|Bilateral Erector Spinae Plane Block (ESPB)|Bilateral ESPBs will be placed after anesthesia induction in eligible and consented patients who are undergoing a sternotomy for congenital heart repair. Patients will receive a local anesthetic agent through each catheter prior to surgery start. If possible, levels of the local anesthetic will be measured during the case. After surgery, patients will be admitted to the CVICU and extubation will be managed by the CVICU team. The ESPB group will have an automatic, alternating side boluses of the local anesthetic started through their nerve block catheters. Levels of the local anesthetic will be measured at intervals.
15904920|NCT03611361|Device|SpectralMD DeepView Wound Imaging System 2.0|The DeepView is an imaging device which simultaneously performs multispectral imaging (MSI) measurements across the visible and infrared spectrum to obtain a quantitative tissue viability assessment. These optical measurements are integrated using a machine learning (ML) algorithm to categorize microvascular blood flow and provide a quantitative assessment for selection of tissue healing.
15904921|NCT03611348|Drug|Latanoprost|"Topical application of latanoprost 0.005% eye drops solution only twice daily for 3 months.
~To apply latanoprost solution, one drop of the solution will be distributed over 1cm2 of depigmented skin. Side effects will be recorded."
15904922|NCT03611348|Device|Microneedling|A superficial micro-needling technique will be done in millimeters according to depth of skin. The vitiliginous area and a thin surrounding rim (about 2 mm) will be subjected to micro-needling with dermapen. The depth of abrasion will be guided by the depth adjustor according to depth of skin on the affected area. This will be followed by the appearance of multiple, tiny, punctate, bleeding points
15904923|NCT03611335|Behavioral|CATCH Interviews|Baseline interviews are conducted with CATCH staff (5/site); while Post-implementation interviews are conducted 9-12 months after introduction of CATCH, with CATCH staff (5/site) and patients (5/site)
15904924|NCT03611322|Drug|Semaglutide, 0.25 mg|Semaglutide will be administered subcutaneously (s.c., under the skin) on day 1 and 8 in the morning after an overnight fast of at least 8 hours
15904925|NCT03611322|Drug|Semaglutide, 0.5 mg|Semaglutide will be administered s.c. (under the skin) on day 15 and 22 in the morning after an overnight fast of at least 8 hours
15904926|NCT03611322|Drug|Semaglutide, 1.0 mg|Semaglutide will be administered s.c. (under the skin) on day 29 in the morning after an overnight fast of at least 8 hours
15904927|NCT03611322|Device|DV3372|DV3372 device will be used for administration of semaglutide
15904929|NCT03611309|Other|Surgeon-palliative care team co management|Surgeon-palliative care team co management includes surgeon alone care and palliative care specialist team
15904930|NCT03611309|Other|Surgeon team alone management|The surgeon and surgical team will manage
15904931|NCT03611283|Other|Mouthwash treatment|60 seconds after meals (3 times/day) during 28 days
15904932|NCT03611283|Other|Toothpaste treatment|3 minutes after the mouthwash (3 times/day) during 28 days
15904933|NCT03611283|Other|Mouthwash placebo|60 seconds after meals (3 times/day) during 28 days
15904934|NCT03611283|Other|Toothpaste placebo|3 minutes after the mouthwash (3 times/day) during 28 days
15904935|NCT03611270|Device|Pulmonary Denervation|Pulmonary Denervation (PDN) using the TIVUS™ System will be performed in patient suffering from pulmonary hypertension after completion of screening and eligibility phase, The procedure will be performed during right heart catheterisation. Safety and effectiveness of the PDN treatment will be assessed during one year follow up.
15904936|NCT03611257|Diagnostic Test|dRAST|Infectious diseases specialists will do active antimicrobial stewardship according to dRAST results in addition to Gram staining results and current standard method.
15904937|NCT03611257|Diagnostic Test|Current standard method|Infectious diseases specialists will do active antimicrobial stewardship according to Gram staining results, and current standard method without dRAST results.
15904938|NCT03611244|Device|Portable seat device devised to maintain lumbar lordosis|"The posterior lumbar spine pads are used to maintain lumbar lordosis and fix it with the shoulder strap so that the hip does not slip forward (so that it does not become a sacral sitting posture).
~The seat is equipped with a 5 cm air filled villus cushion to relieve pressure on the ischial tuberosity when sitting for a long time. The portable seat device can be moved so that the DMD can sit on the device even when sitting in a wheelchair or a chair for home, school, or outdoors, so that the lumbar lordosis can be constantly maintained."
15904939|NCT03611231|Drug|Chidamide|Chidamide 20mg orally BIW. Treatment cycles are repeated every 4 weeks.
15904940|NCT03611218|Device|Dialyzer|Three hemodiafiltration sessions assigned to one type of dialyzer FX P600 (Fresenius Medical Care), comparator Sureflux-17UX and comparator Polyflux 170 H
15904941|NCT03611205|Procedure|Computed Tomography|Undergo dPET/CT
15904942|NCT03611205|Procedure|Positron Emission Tomography|Undergo dPET/CT
15904943|NCT03611192|Other|Multicomponent exercise|Aerobic exercise: 15~20 mins Resistance exercise: 15 mins Balance exercise: 15~20 mins Flexibility exercise: 10 mins
15904944|NCT03611192|Other|Home-program exercise|60 mins exercise
15904945|NCT03611179|Drug|Bevacizumab|"The chemotherapy regimen will be Paclitaxel (175 mg/m2 of body surface area) administered intravenously over 3 h, followed by carboplatin (area under the curve 5) over 1 h, with standard antiemetic and hypersensitivity medications.
~In patients who develop dose-limiting peripheral neuropathy or hypersensitivity, paclitaxel will be replaced with docetaxel (75 mg/m2), which is administered intravenously over 1 h.
~Bevacizumab (15 mg/kg bodyweight) administered intravenously initially over 90 min (if tolerated, this time can be reduced to 60 min, and could be further reduced to a minimum of 30 min)"
15904946|NCT03611153|Drug|Oral Myeloperoxidase Inhibitor|A single administration dose of 30 mg oral MPO inhibitor given orally following baseline, resting and exercise testing in patients during right heart catheterization.
15904947|NCT03611153|Drug|Placebo oral capsule|A single administration dose of 30 mg placebo given orally following baseline, resting and exercise testing in patients during right heart catheterization.
15904948|NCT03611140|Dietary Supplement|DP|a package containing a mix of functional foods
15904949|NCT03611140|Dietary Supplement|Placebo|a package containing maltodextrins and caseinate calcium to mimic the DP
15904950|NCT03611127|Other|pulmonary rehabilitation|pulmonary rehabilitation standardized program
15904951|NCT03611114|Dietary Supplement|Blood orange juice|
15904952|NCT03611114|Dietary Supplement|Control drink|
15904953|NCT03611088|Other|Kangaroo Position.|The kangaroo position - the newborn is positioned in the adult's breasts, face down, should be dressed in light clothes and wrapped in a flexible cloth.
15904954|NCT03611075|Other|No Intervention|No interventions are administered in this study
15904955|NCT03611062|Behavioral|VR Executive Functions Training|"The Windows 10-based VICT program invites children to rescue an animated character named Lubdub from a castle. The program consists of three challenging and child-friendly tasks that correspond to the three core EFs."
15904956|NCT03611062|Behavioral|VR Placebo Game|In this game, children in the control group will use the VR hand controller to cast different types of spells (bees, bouncy balls, sparkler spells) to objects in the virtual world. Objects in the VR world will all react differently to a spell being cast so as to provide children a relaxing and EF-free gaming experience.
15904957|NCT03611049|Dietary Supplement|High dose Vitamin D3|High dose arm- 5000IU given daily
15904958|NCT03611049|Dietary Supplement|Low dose Vitamin D3|Low dose arm-800 IU given daily
15904959|NCT03611036|Other|Strength training|Upper limbs Strength training; done with dumbbells whose weight corresponds to 60-80% of the maximal voluntary force in abduction measured initially, during 4 weeks
15904960|NCT03611036|Other|Endurance training|Upper limbs Endurance training of the ; done with dumbbells whose weight corresponds to 30% of the maximum voluntary force in abduction measured initially, during 4 weeks
15904961|NCT03611010|Drug|Atorvastatin injection|statin (i.e., 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor) for injection
15904962|NCT03610997|Procedure|Photorefractive keratectomy|
15904963|NCT03610984|Other|type 1 diabetes structured education|The structured education is based on a regular outpatients visit.It is an education that integrated several diabetes related subjects,which mainly aimed at T1D self-management.
15904964|NCT03610971|Drug|Ruxolitinib|Ruxolitinib: 15 mg by mouth (PO) twice a day (BID).
15904965|NCT03610971|Drug|BCR-ABL Tyrosine Kinase Inhibitor (TKI)|The BCR-ABL TKIs that will be used include imatinib, dasatinib, nilotinib or bosutinib.
15904966|NCT03610958|Device|Epitomee Device|A non-surgical, non-pharmacologic, medical Device designed to enhance the feeling of satiety.
15904967|NCT03610945|Drug|Fluconazole|Subjects will receive fluconazole once daily from Day 5 to Day 18
15904968|NCT03610945|Drug|Quinidine|Subjects will receive quinidine twice daily from Day 5 to Day 12
15904969|NCT03610945|Drug|EDP-305|Subjects will receive a single dose of EDP-305 on Day 1 and Day 14
15904973|NCT03610919|Drug|Nasal Sprays|Intranasal administration of 24 international units per dose.
15904974|NCT03610906|Procedure|Tumor and Blood Specimens|If available, specimen will be sampled from within the tumor, and not include portions of the tumor capsule. If the tumor includes a cyst, fluid from the cyst will be sampled if available. For each tumor specimen, a companion sample of blood that would otherwise be disposed of through usual clinical practice in the operating room will also be collected.
15904975|NCT03610893|Drug|Dexamethasone|Dexamethasone as perineural local anesthetic adjuvant
15904976|NCT03610893|Drug|Dexmedetomidine|Dexmedetomidine as perineural local anesthetic adjuvant
15904977|NCT03610880|Drug|TG-2349 (400 mg) plus DAG181 (200 mg)|Dosing period 1 (Day 1 to 7): TG-2349 400 mg； Dosing period 2 (Day 8 to 14): TG-2349 400 mg + DAG181 200 mg
15904978|NCT03610880|Drug|DAG181 (200 mg) plus TG-2349 (400 mg)|Dosing period 1 (Day 1 to 7): DAG181 200 mg； Dosing period 2 (Day 8 to 14): TG-2349 400 mg + DAG181 200 mg
15904979|NCT03610867|Drug|Furaprevir capsule (SAD)|There are four doses in this part, 100 mg, 200 mg, 400 mg, and 600 mg. Each subject will receive the sample once by oral administration.
15904980|NCT03610867|Drug|Furaprevir capsule (MAD)|There are three doses in this part, 200 mg, 400 mg, and 600 mg. Each subject will be allocated into one dosing regimen and receive the sample once daily for 5 consecutive days by oral administration.
15904981|NCT03610867|Drug|Placebo (SAD)|Each subject will receive the sample once by oral administration.
15904982|NCT03610867|Drug|Placebo (MAD)|Each subject will be allocated into one dosing regimen and receive the sample once daily for 5 consecutive days by oral administration.
15904983|NCT03610854|Device|Fitness Tracker|Patients will continuously wear a commercially available fitness tracker which will collect data on physical activity (steps), pulse rate and sleep behaviour.
15904984|NCT03610841|Diagnostic Test|preterm labor|liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine
15904985|NCT03610841|Diagnostic Test|healthy|liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine
15904986|NCT03610828|Other|Vegetarian or Vegan Diets|Diets that omit all animal products (vegan diet) or all animal products with the exception of eggs and/or dairy products (vegetarian)
15904987|NCT03610815|Behavioral|Screening, Brief Intervention, Referral to Treatment|Screening, Brief Intervention, Referral to Treatment
15904988|NCT03610789|Device|REDAPT|REDAPT Monolithic Sleeveless Stems and Acetabular Cup Components
15904989|NCT03610776|Device|Portion control plate|Portion control plate including demarcations and pictures for recommended amounts of main food groups (starch, protein and vegetables), 25 cm in diameter, enamel, white background.
15904990|NCT03610776|Device|Conventional plate|Conventional plate without demarcations or images, 25 cm in diameter, enamel, white.
15904991|NCT03610763|Device|Transcranial Direct Current Stimulation|Transcranial direct current stimulation (tDCS) is a portable neurostimulation method that modulates cortical excitability. The technique involves placing two saline-soaked electrodes (anode and cathode) on the scalp and passing a small direct current (1.5 milliamps; mA) between them. Cortex underlying the anode is more easily excited due to lowered thresholds for depolarization of glutamatergic neurons, while thresholds are increased in neurons beneath the cathode, making them less excitable. Sham stimulation is easily implemented, and the technique can be effectively double-blinded.
15904992|NCT03610763|Behavioral|Modified Constraint Induced Movement Therapy|In CIMT, patients are required to wear a mitt that restricts use of the unaffected limb while they practice structured tasks and also engage in activities of daily living.
15904993|NCT03610750|Other|psychiatric medications and evidence-based psychotherapies|Patients who screen positive with any psychiatric condition are referred for evaluation and treatment according to the treatment arm. This may combine psychiatric medications or evidence based psychotherapies according to treatment.
15904994|NCT03610737|Device|MILD Procedure|"The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue.
~Other Name: MILD lumbar decompression"
15904995|NCT03610737|Other|Conventional Medical Management (CMM)|CMM can include physical therapy, home exercise, pain medication, epidural steroid injections, nerve blocks, and other lumbar steroid injections.
15904996|NCT03610724|Biological|Tisagenlecleucel|Single intravenous infusion
15904997|NCT03610711|Drug|Nivolumab|240mg administered IV over 30 minutes every 2 weeks for one year
15904998|NCT03610711|Drug|Relatlimab|every 2 weeks for one year
15904999|NCT03610698|Behavioral|LEAF Positive Emotion Intervention|5-week online intervention teaching 8 positive emotions skills for caregivers
15905000|NCT03610698|Other|Emotion Reporting Control Condition|Daily reporting of emotions for participants assigned to the control condition.
15905001|NCT03610685|Drug|Prednisolone|Given daily for 2 weeks
15905002|NCT03610685|Drug|Placebo oral capsule|Given daily for 2 weeks
15905003|NCT03610672|Behavioral|OD prevention/response training|Participants will view a 13-minute OD prevention and response training video (available online free-of-charge). This video covers NY State's recommended curriculum for Overdose Prevention: how to prevent, identify, and respond to an OD, including information on the factors that could heighten risk for overdose (mixing drugs, changes in tolerance and drug purity, and using alone), how to respond to an overdose (rescue breathing, calling 911), and specific instructions on how and when to administer naloxone to someone who is overdosing. After the video, research staff will review key information, answer any questions participants may have, demonstrate assembly of the intranasal naloxone atomizer and ensure participants are able to assemble it. A prescription for naloxone, as well as a standard naloxone kit containing two doses of the medication and atomizers for intranasal administration, will be given to participants, along with printed literature reviewing key training information.
15905004|NCT03610672|Behavioral|OD prevention/response training + PI mobile application|Participants will receive the same OD intervention as those in the first arm, as well as receiving mobile phones pre-loaded with the PI App. This intervention includes daily prompts plus key components of evidence-based cognitive behavioral interventions, including Functional Analysis of Drug Use, Self-Management, and Social/Recreational Counseling and additional content on Distress Tolerance, the relationship between Peer Networks and Drug Use, and pertinent resources.
15905096|NCT03610035|Drug|NPT189|IgG1 Fc-GAIM fusion protein, a recombinant fusion protein
15905005|NCT03610646|Drug|MYL-1701P|"Subjects will receive intravitreal injections of MYL-1701P throughout the 52-week treatment period, with the last dose at 48 weeks.
~The additional doses may be administered in accordance with the protocol."
15905006|NCT03610646|Drug|Eylea|"Subjects will receive intravitreal injections of Eylea throughout the 52-week treatment period, with the last dose at 48 weeks.
~The additional doses may be administered in accordance with the protocol."
15905007|NCT03610633|Drug|Oxytocin|The neuropeptide oxytocin (OT) increases social approach, trust, and reduces anxiety to social stress.
15905008|NCT03610633|Drug|Placebo|Saline solution.
15905009|NCT03610620|Procedure|Vivascope 2500 ex-vivo fluorescent confocal microscope|scanned with the Vivascope 2500
15905010|NCT03610607|Behavioral|Intense education|we will inform patients with their own data including the number of P. gingivalis and ratio of S. cristatus and P. gingivalis detected immediately after periodontal treatment and 3 month after the treatment. Explaining these data in detail, in terms that the patient can understand, are equally as important as teaching the plaque control techniques.
15905011|NCT03610594|Other|Kalaripayattu|Combination of Exercise, breathing, meditation, combat practices
15905012|NCT03610581|Biological|Ad26.HPV16|Participants will receive Ad26.HPV16 as a solution for intramuscular injection.
15905013|NCT03610581|Biological|Ad26.HPV18|Participants will receive Ad26.HPV18 as a solution for intramuscular injection.
15905014|NCT03610581|Biological|MVA.HPV16/18|Participants will receive MVA.HPV16/18 as a solution for intramuscular injection.
15905015|NCT03610581|Biological|Placebo|Participants will receive matched placebo as a solution for intramuscular injection.
15905016|NCT03610568|Behavioral|Growing up GREAT! Intervention|The Growing up GREAT! intervention is built around the socio-ecological model. For young adolescents, a suite of materials provides information and prompts discussion about puberty, gender equality, healthy relationships, violence, and other related themes during weekly club sessions. For parents, group sessions featuring six testimonial videos foster discussion around non-violent parenting, equal sharing of household tasks, and girls' education. Other materials for teachers, health workers, and community members complement the core toolkit materials.
15905017|NCT03610555|Other|new patient centered website|
15905018|NCT03610542|Behavioral|Triggers for anxiety|Students learn about different triggers for anxiety, what the signs and indicators of anxiety are, and identify their own triggers for anxiety
15905019|NCT03610542|Behavioral|Identifying and challenging negative thoughts|Students learn about the types of unrealistic thoughts that underpin anxiety and how anxiety can be reduced with more realistic thoughts. Students identify their own unrealistic thoughts that contribute to anxiety and what more realistic thoughts can be used.
15905020|NCT03610542|Behavioral|Relaxation|Students are taught to relax through (1) breathing exercises, (2) progressive muscle relaxation, and (3) imagery. Student practice these techniques.
15905021|NCT03610542|Behavioral|Goal Setting|Students learn how to set goals, monitor goal progress, and check when goals have been achieved. Students then identify their own goals.
15905022|NCT03610542|Behavioral|Overcoming avoidance|Students identify ways that they avoid anxiety-provoking situations (e.g., procrastinating exam study). Students develop plans for exposure to anxiety-provoking situations and learn study strategies to build confidence.
15905023|NCT03610529|Device|CardioSenseSystem|CardioSensySystem is a novel wireless ECG monitoring system developed by Novosense AB for monitoring of ECG in health care departments.
15905024|NCT03610529|Device|Philips Intellivue|Philips Intellivue in an established ECG monitoring system used at the clinical investigational device.
15905027|NCT03610503|Other|Music|Participants in this arm will listen to music during the EMG testing
15905028|NCT03610490|Biological|Autologous Tumor Infiltrating Lymphocytes MDA-TIL|Given IV
15905029|NCT03610490|Drug|Cyclophosphamide|Given IV
15905030|NCT03610490|Drug|Fludarabine|Given IV
15905031|NCT03610490|Biological|Interleukin-2|Given IV
15905032|NCT03610490|Other|Quality-of-Life Assessment|Ancillary studies
15905033|NCT03610477|Dietary Supplement|Medium chain triglycerides|Gel capsules, each containing 1 gram
15905034|NCT03610477|Dietary Supplement|Long chain triglycerides|Gel capsules, each containing 1 gram
15905035|NCT03610464|Drug|Amphetamine Extended Release Suspension [Dyanavel]|1 mL of study drug (AMPH EROS, 2.5 mg/mL), pharmacokinetic analysis
15905036|NCT03610451|Behavioral|Floatation-REST plus usual care|Individuals will receive Floatation-REST plus usual care. Floating creates an environment with minimal visual, auditory, tactile, proprioceptive, and thermal input to the brain. The float rooms are lightproof and soundproof. A high concentration Epsom salt water solution allows individuals to effortlessly float on their back while remaining completely still, reducing both proprioceptive and tactile input to the brain. The temperature of the water is calibrated to the temperature of the skin (~94° F) and the temperature of the air is calibrated to the temperature of the water, making it difficult to discern the boundary between air and water, thus reducing thermal input to the brain while minimizing the need for thermoregulation of the skin.
15905037|NCT03610451|Behavioral|Usual care|Individuals will receive usual care on the inpatient unit of the Laureate Eating Disorders Program.
15905038|NCT03610438|Drug|Inotuzumab Ozogamicin (IO)|"After course 1 MRD will be evaluated:
~- patients MRD negative will enter into short maintenance or long maintenance according to investigator choice. After 4 to 12 weeks in short maintenance patient will undergo SCT, otherwise, patients will enter long maintenance."
15905039|NCT03610438|Drug|Inotuzumab Ozogamicin (IO)|After course 2 MRD will be evaluated; patients MRD negative will enter into short maintenance or long maintenance by investigator choice. After 4 to 12 weeks in short maintenance patient will undergo SCT, otherwise, patients will enter long maintenance.
15905040|NCT03610412|Other|Cinnamomum Cassia|The intervention period will be 90 days, unlike other trials with Cinnamomum cassia and the main effect sought is on IGF1 levels, in addition to metabolic control.
15905041|NCT03610412|Other|Placebo (calcined magnesia)|The intervention period will be 90 days, unlike other trials with Cinnamomum cassia and comparison with placebo. The main effect sought is on IGF1 levels, in addition to metabolic control.
15905042|NCT03610399|Drug|Primaquine|Different total dose and supervision.
15905043|NCT03610386|Other|Adding menthoxypropanediol to the biopsy|Two biopsies of skin (4 mm diameter each) will be taken under local anesthetic in the service of dermatology of Brest CHRU. They will be situated in a pruritic lesion area little or not visible (inside of the arm, the back …). One of the two biopsies will receive menthoxypropanediol topically.
15905044|NCT03610386|Other|No adding menthoxypropanediol to the biopsy|Two biopsies of skin (4 mm diameter each) will be taken under local anesthetic in the service of dermatology of Brest CHRU. They will be situated in a pruritic lesion area little or not visible (inside of the arm, the back …). One of the two biopsies will not receive menthoxypropanediol.
15905045|NCT03610373|Behavioral|Modular Approach to Therapy for Children (MATCH)|MATCH is a collection of 31 modules that correspond to the treatment procedures included in standard evidence-based treatments for youth depression, anxiety, and behavioral disorders.
15905046|NCT03610360|Drug|MesoPher|Subjects in Arm A will undergo leukapheresis to obtain monocytes from which dendritic cells will be generated. These dendritic cells will be loaded in vitro with an allogeneic tumor cell lysate (PheraLys). Treatment with autologous dendritic cells loaded with PheraLys is called MesoPher
15905047|NCT03610347|Device|Bare metal Stent plus Paclitaxel Balloon|
15905048|NCT03610347|Device|Drug Eluting Stent|
15905049|NCT03610334|Drug|IFB-088 oral capsule|"In SAD phase: single daily dose of IFB-088 will be administered in doses ranging from 2.5mg (cohort #1 in one intake) to 60mg (cohort #2 to #6 in two intakes separated by a interval of 12 hours).
~In MAD phase: multiple doses of IFB-088 will be administered daily during 14 days, in two intakes separated by an interval of 12 hours. The dose levels of the 3 cohorts will be determined after SAD phase."
15905050|NCT03610334|Drug|Placebo oral capsule|"In SAD phase: single daily dose of placebo (cellulose microcrystalline) will be administered in doses ranging (equivalent-weight) from 2.5mg (cohort #1 in one intake) to 60mg (cohort #2 to #6 in two intakes separated by a interval of 12 hours).
~In MAD phase: multiple doses of placebo (cellulose microcrystalline) will be administered daily during 14 days, in two intakes separated by an interval of 12 hours."
15905051|NCT03610321|Drug|Gefarnate|Gefarnate (100 mg, three times daily, oral) treatment for 1 month.
15905052|NCT03610321|Drug|Statin|Statin treatment (atorvastatin 20 mg or rosuvastatin 10 mg, once daily, oral) for 1 month.
15905053|NCT03610295|Procedure|PPI group|The patients underwent cataract extraction, posterior capsulotomy, anterior vitrectomy combined with prophylactic peripheral iridectomy.
15905054|NCT03610295|Procedure|cataract extraction|The patients underwent cataract extraction, posterior capsulotomy combined with anterior vitrectomy and leave the iris intact.
15905055|NCT03610282|Drug|IV Methylphenidate|Subjects will receive a bolus of IV methylphenidate during propofol infusion at one of the study visits.
15905056|NCT03610282|Drug|Propofol|Subjects will received propofol for up to 100 minutes.
15905057|NCT03610269|Device|INVSENSOR00026 (Pulse CO-Oximeter and sensor)|Noninvasive Pulse CO-Oximeter and sensor that measures noninvasive hemoglobin (SpHb)
15905058|NCT03610256|Procedure|SADI-S|Laparoscopic SADI-S, recently described as an evolution of the BPD-DS, combining the physiological advantages of pylorus preservation and the technical benefits of single-loop reconstruction, associating a sleeve gastrectomy and a duodeno-ileal bypass at 2.5 meters from the ileo-caecal valve if BMI ≥ 50 kg/m² or at 3 meters if BMI < 50
15905059|NCT03610256|Procedure|RYGB|"The laparoscopic Roux-en-Y Gastric Bypass will consist of:
~a small gastric pouch (about 30cc)
~an antecolic alimentary limb
~a gastro-jejunal anastomosis using a linear stapler
~a 150cm long alimentary limb
~a 50cm biliary limb
~a latero-lateral jejuno-jejunal anastomosis
~closure of the mesenteric defects"
15905060|NCT03610243|Behavioral|Self-administered acupressure|Two 2-hour one-on-one training sessions in patient-centered self-administered acupressure will be provided by trainers in the first week (4 hours) in the patient's home or at the university, depending on his/her preference. From the second to fourth weeks of the intervention, participants will engage in 15 minutes of self-administered acupressure twice a day (for a total of 10.5 hours over the 3 weeks). They will log the frequency of self-practice in a diary and be encouraged to undertake self-practice beyond the 4-week intervention. At weeks 2, 3, and 4, a 1-hour follow-up visit will be conducted by the same team of trainers to reinforce learning and self-practice (for a total of 3 hours over the 3 weeks).
15905061|NCT03610230|Drug|Iron Isomaltoside|Iron Isomaltoside 1000 (Monofer®) consists of iron with a tighter binding to its carbohydrate moiety with less free iron
15905062|NCT03610230|Drug|Iron sucrose|the currently most widely used intravenous iron preparation with good safety profile
15905063|NCT03610217|Other|Interstitial lung disease induction algorithm|Patients failing first line mycophenolic acid (MFA) will be randomized to MFA plus rituximab or intravenous cyclophosphamide. If they fail the second line they will be crossed over to the other option.
15905064|NCT03610217|Other|Pulmonary arterial hypertension algorithm|Patients diagnosed with pulmonary arterial hypertension secondary to systemic sclerosis will be randomized to receive anticoagulation (warfarin, rivaroxaban or apixaban)
15905065|NCT03610217|Other|Raynaud's phenomenon algorithm|"Patients with mild Raynaud's phenomenon not responding to the first line treatment (nifedipine), will be randomized to receive losartan or nifedipine plus atorvastatin or nifedipine plus losartan. If they fail the second line they will be crossed over to the other options randomly.
~Patients with severe Raynaud's phenomenon not responding to the first line treatment (nifedipine) or failing the previous mild Raynaud's algorithm, will be randomized to receive nifedipine plus sildenafil or nifedipine plus intravenous iloprost. If they fail the second line they will be crossed over to the other option."
15905066|NCT03610217|Other|Digital ulcer algorithm|"Patients with active digital ulcers not healing after 3 months or developing new ones with nifedipine will be randomized to nifedipine plus sildenafil or nifedipine plus intravenous iloprost. If they fail the second line they will be crossed over to the other option.
~Patients who develop new digital ulcers under treatment with nifedipine will be randomized to nifedipine plus atorvastatin plus standard of care or nifedipine plus standard of care. If they fail the second line they will be crossed over to the other option."
15905067|NCT03610217|Other|Inflammatory arthritis algorithm|Patients with inflammatory arthritis failing methotrexate and/or prednisone and/or hydroxychloroquine and/or sulfasalazine will be randomized to receive intravenous rituximab or subcutaneous tocilizumab. If they fail the second line they will be crossed over to the other option.
15905097|NCT03610035|Drug|Placebo|Placebo
15905742|NCT03605056|Drug|lenalidomide|25 mg/d, will be administered orally on Days 1-14 each 21 day cycle
15905068|NCT03610217|Other|Gastroesophageal reflux algorithm|Patients with gastroesophageal reflux failing standard doses of proton pump inhibitors (PPI) will be randomized to receive double doses of PPI or standard dose of PPI plus ranitidine or double doses of PPI plus domperidone or double doses of PPI plus prucalopride/erythromycin. If they fail the second line they will be crossed over to the other options randomly.
15905069|NCT03610217|Other|Bacterial overgrowth algorithm|Patients with bacterial overgrowth will be randomized to receive erythromycin or metronidazole or amoxicillin. If they fail the second line they will be crossed over to the other options randomly.
15905070|NCT03610217|Other|Constipation algorithm|Patients with constipation will be randomized to receive bisacodyl or magnesium sulphate or polyethylene glycol or senna.If they fail the second line they will be crossed over to the other options randomly.
15905071|NCT03610217|Other|Skin involvement algorithm|"Patients with skin involvement and modified Rodnan skin score <32 will be randomized to receive methotrexate or mycophenolic acid or methotrexate plus mycophenolic acid. If they fail the second line they will be crossed over to the other option.
~Patients with skin involvement and modified Rodnan skin score >32 will be randomized to receive methotrexate plus mycophenolic acid or intravenous cyclophosphamide. If they fail the second line they will be crossed over to the other option."
15905072|NCT03610217|Other|Pain algorithm|Patients with pain failing first line treatment with acetaminophen or celecoxib or ibuprofen will be randomized to receive pregabalin or duloxetine. Patients with skin involvement and modified Rodnan skin score <32 will be randomized to receive methotrexate or mycophenolic acid or methotrexate plus mycophenolic acid. If they fail the second line they will be crossed over to the other option. In case they fail the second line they will be treated with medical marijuana.
15905073|NCT03610204|Other|Buffalo horn technique|The participants receive a 30-min massage session, twice a week for a total 6 sessions.
15905074|NCT03610191|Diagnostic Test|Serum biomarker tests|Blood was collected at preoperatively, immediately after operation and 24 h after operation in patients from the surgical group but not volunteers. Serum MD2, CysC, DNA methylation marker and SNP mutation sites on CTNNA2 gene were test.
15905075|NCT03610191|Behavioral|Neuropsychological battery tests|both surgical patients and volunteers will accept three times of NPB tests. For surgical patients the tested time point are preoperative, one day before discharge and 3 months after surgery. For volunteers the tested time interval would be similar to that of surgical patients.
15905076|NCT03610191|Procedure|Cardiac surgery|patients scheduled for cardiac surgery will accept the surgical procedure.
15905077|NCT03610178|Other|Life-style modification, insulin therapy if needed|All patients are assigned to life-style modification (diet and physical exercise). If target glucose levels (<5.1 mmol/L fasting and <7.0 mmol/L postprandial) are not achieved insulin therapy is started
15905078|NCT03610178|Other|Life-style modification, insulin therapy if needed|All patients are assigned to life-style modification (diet and physical exercise). If target glucose levels (<5.3 mmol/L fasting and <7.8 mmol/L postprandial) are not achieved insulin therapy is started
15905079|NCT03610165|Device|Acumen HPI-enabled EV1000 screen|Acumen HPI-enabled EV1000 screen.
15905080|NCT03610165|Device|Control|Arterial waveform and pressures
15905081|NCT03610152|Behavioral|Hospital Policy change|Implementation of a hospital wide policy whereby medically necessary preoperative tests for patients undergoing ambulatory surgery will be ordered at the discretion of the consulting anesthesiologist based on their clinical assessment of the patient.
15905082|NCT03610139|Dietary Supplement|Vitamin D3|At baseline, patients with deficient 25(OH)D levels will be randomly assigned 1:1 to receive either the high dose or standard dose vitamin D supplementation.
15905083|NCT03610126|Procedure|volume controlled ventilation|the patients will be ventilated by volume controlled ventilation after insertion of the BASKA laryngeal mask airway
15905084|NCT03610126|Procedure|pressure controlled ventilation|the patients will be ventilated by pressure controlled ventilation after insertion of the BASKA laryngeal mask airway
15905085|NCT03610113|Device|Reverse shoulder arthroplasty|The implantation of reverse shoulder prosthesis, and reattachment of greater and lesser tuberosities
15905086|NCT03610100|Drug|Acelarin|825 mg/m2 administered intravenously over 15 to 30 minutes on days 1, 8 and 15 of a 28 day cycle. Number of Cycles: until disease progression or unacceptable toxicity develops.
15905087|NCT03610100|Drug|Gemcitabine|1000 mg/m2 administered intravenously as a 30 minute infusion on days 1, 8 and 15 of a 28 day cycle. Number of Cycles: until disease progression or unacceptable toxicity develops.
15905088|NCT03610087|Behavioral|Low Intensity Intervention|Participants will have access via the online platform to the NAVIGATE self-help modules for physical activity, nutrition and quitting smoking with a list of community resources. Subjects will be sent a standard reminder emails once per week to complete their modules and connect with their main provider for any assistance.
15905089|NCT03610087|Behavioral|High Intensity Intervention|Participants will receive individualized treatment planning, in collaboration with a Care Coordinator, and the Virtual Care Team (VCT). Interactive modules on physical activity, nutrition and quitting smoking will be provided via the online platform. the virtual team will be engaged to provide treatment and/or recommendations regarding the following: increasing physical activity, improving nutrition and diet, smoking cessation (psychosocial support plus medications), and medication adherence. Participants in this arm will have weekly check-ins with their assigned Care Coordinator where they will be able to discuss VCT recommendations, and progress on their goals.
15905090|NCT03610074|Other|Mint Ice Cube|Application in patient's mouth of 3 mint ice cubes
15905091|NCT03610074|Procedure|Blood test|Additional blood test 5 min after mint ice cubes application
15905092|NCT03610074|Other|Patient's questioning|Patient's questioning before mint ice cubes application and at 5 min, 1h, 2h, 4h, 12h and 24h from mint ice cubes application
15905093|NCT03610061|Drug|Durvalumab|"All patients will receive:
~Day 1-Day 5: External Beam Radiotherapy to target site(s)-daily for 5 days (i.e. 5 fractions).
~D2: Commence durvalumab. Continue 4-weekly until disease progression. Patients can continue until a second radiological progression if clinical benefit is ongoing."
15905094|NCT03610061|Radiation|Radiotherapy|"All patients will receive:
~Day 1-Day 5: External Beam Radiotherapy to target site(s)-daily for 5 days (i.e. 5 fractions).
~D2: Commence durvalumab. Continue 4-weekly until disease progression. Patients can continue until a second radiological progression if clinical benefit is ongoing."
15905095|NCT03610048|Drug|ALKS 5461|samidorphan + buprenorphine administered sublingually
15905098|NCT03610022|Drug|Treatment with vismodegib|Vismodegib 150 mg capsules is administered daily with or without food until disease progression or unacceptable toxicity. Patients are followed in the dermatologic unit of Bordeaux University Hospital (Saint André Hospital) every month. At each consultation, clinical and biological datas, and two blood samples are collected just before taking the drug. One sample is for vismodegib quantification (pharmacokinetic protocol), and the other for the determination of alpha-1 glycoprotein acid level
15905099|NCT03610009|Device|2D ultrasound|The timing of final follicle maturation and oocyte retrieval based on follicle tracking with use of conventional two-dimensional (2D) ultrasound.
15905100|NCT03610009|Device|SonoAVC|The timing of final follicle maturation and oocyte retrieval based on follicle tracking with use of SonoAVC.
15905101|NCT03609996|Device|Panretinal Photocoagulation|Laser treatment for PDR
15905102|NCT03609996|Drug|Lucentis|Intraviteral injection
15905103|NCT03609983|Other|Daily weighing with daily feedback on weight|"Participants will weigh themselves using a Yunmai SE Scale one time each day upon rising from bed beginning in one week, every day for four weeks. After 2 weights have been collected, participants will begin to receive daily feedback on their change in weight and suggestions to maintain energy balance. They will receive an email stating, Your weight today is _______. Your weight has (increased/decreased) _____ pounds since yesterday. If their weight has increased, the email will include one example of how to decrease their energy balance by 150 calories. If participants' weight has decreased, the email will include one example of how to increase energy balance by 150 calories."
15905104|NCT03609983|Other|Weekly weighing with weekly feedback on weight|"Participants will weigh themselves using a Yunmai SE Scale one time each week upon rising from bed beginning the following day for four weeks. After 2 weights have been collected, participants will begin to receive weekly feedback on their change in weight and suggestions to maintain energy balance. They will receive an email stating, Your weight today is _______. Your weight has (increased/decreased) _____ pounds since last week. If their weight has increased, the email will include one example of how to decrease their energy balance by 150 calories. If participants' weight has decreased, the email will include one example of how to increase energy balance by 150 calories."
15905105|NCT03609970|Dietary Supplement|Vitamin D|Daily 4X 1000IU cholecalciferol
15905106|NCT03609970|Radiation|UVR (Solar simulated radiation)|1.25 SED Solar simulated radiation twice weekly
15905107|NCT03609957|Other|Aerobic Exercise Training|Traditional, continuous aerobic exercise (cycling) at a moderate intensity
15905108|NCT03609957|Other|Interval Training|High-intensity interval exercise consisting of short bursts of exercise interspersed with rest periods
15905109|NCT03609944|Procedure|ERCP with miES|Endoscopic retrograde cholangiopancreatography with minor papilla endoscopic sphincterotomy
15905110|NCT03609944|Procedure|EUS|Endoscopic ultrasound
15905111|NCT03609931|Procedure|Mitral Valve Model|Creation of a mitral valve patient specific model to see if it mimics the patients valve
15905112|NCT03609905|Biological|Adipose-cord mesenchymal stromal cells (A-MSCs)|A-MSCs 5 x 10~7 diluted on 100 mL of normal saline
15905113|NCT03609905|Other|Conventional drugs|5-amino-salicylic acid or glucocorticoid
15905114|NCT03609892|Drug|Berberine|Berberine-amoxicillin quadruple therapy group: given for 14 days at a dose of berberine 100 mg 3 tablets TID, amoxicillin 500 mg 2 capsules BID ，esomeprazole 20 mg BID, ,and Bismuth 100 mg 2 capsules BID.
15905115|NCT03609892|Drug|Amoxicillin|Berberine-amoxicillin quadruple therapy group: given for 14 days at a dose of Amoxicillin 500 mg 2 capsules BID plus berberine 100 mg 3 tablets TID, esomeprazole 20mg 1tablet BID, and bismuth 100 mg 2 capsules BID
15905116|NCT03609892|Drug|Esomeprazole|Berberine-amoxicillin quadruple therapy group: given for 14 days at a dose of Esomeprazole 20mg 1 tablet BID plus berberine 100 mg 3 tablets TID,amoxicillin 500 mg 2 capsules BID, and bismuth 100 mg 2 capsules BID
15905117|NCT03609892|Drug|Bismuth|Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of Tetracycline 250mg 2 capsules TID plus furazolidone 100mg 1 tablets BID，esomeprazole 20 mg 1 tablets BID and bismuth 100 mg 2 capsules BID
15905118|NCT03609892|Drug|Tetracycline|Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of Tetracycline 250mg 2 capsulesTID plus furazolidone 100mg 1 tablets BID，esomeprazole 20 mg 1 tablets BID and bismuth 100 mg 2 capsules BID
15905119|NCT03609892|Drug|Furazolidone|Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of furazolidone 100mg 1 tablets BID plus Tetracycline 250mg 2 capsulesTID，esomeprazole 20 mg 1 tablets BID and bismuth 100 mg 2 capsules BID
15905120|NCT03609892|Drug|Esomeprazole|Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of esomeprazole 20 mg 1 tablets BID plus Tetracycline 250mg 2 capsules TID, furazolidone 100mg 1 tablets BID， and bismuth 100 mg 2 capsules BID
15905121|NCT03609892|Drug|Bismuth|Tetracycline-furazolidone containing quadruple therapy group: given for 14 days at a dose of bismuth 100 mg 2 capsules BID plus Tetracycline 250mg 2 capsules TID ，furazolidone 100mg 1 tablets BID and esomeprazole 20 mg 1 tablets BID
15905122|NCT03609879|Device|Ambu Perfect ACE|patient with a fitted cervical collar (Ambu Perfect ACE) established by an experienced instructor. Cervical collar set up for 20 minutes
15905123|NCT03609879|Device|Philly One-Peace Collar|patient with a fitted cervical collar (Philly One-Peace Collar) established by an experienced instructor. Cervical collar set up for 20 minutes
15905124|NCT03609879|Device|Necloc Collar|patient with a fitted cervical collar (Neclock Collar) established by an experienced instructor. Cervical collar set up for 20 minutes
15905125|NCT03609879|Device|NexSplit Plus|patient with a fitted cervical collar (NexSplit Plus) established by an experienced instructor. Cervical collar set up for 20 minutes
15905126|NCT03609879|Device|NECKLITE|patient with a fitted cervical collar (NECKLITE) established by an experienced instructor. Cervical collar set up for 20 minutes
15905127|NCT03609866|Procedure|rapid thoracic compression technique|in the expiratory time of the ventilation set, it will be applied a rapid thoracic compression
15905128|NCT03609866|Procedure|metatarsophalangeal joint passive mobilization|it will be performed a metatarsophalangeal joint passive mobilization technique on the patient
15905129|NCT03609853|Drug|Placebo|Placebo vapor (distilled water)
15905130|NCT03609853|Drug|Vaporized THC, limonene, or THC and limonene|Acute drug exposure
15905131|NCT03609840|Drug|Thiotepa|Given IV
15905132|NCT03609827|Drug|Melphalan|
15905137|NCT03609775|Drug|ACT-541468|One tablet of 50 mg ACT-541468 will be administered orally.
15905138|NCT03609775|Other|ACT-541468 placebo|Matching ACT-541468 placebo will be administered orally as 1 tablet.
15905139|NCT03609775|Other|Ethanol 10%|Ethanol 10% w/v solution in 5% glucose will be administered i.v. for 5 h and clamped at an ethanol level of 0.6 g/L.
15905140|NCT03609775|Other|Ethanol placebo|Matching placebo for the ethanol infusion (i.e., 5% glucose solution) will be administered i.v. for 5 h.
15905141|NCT03609762|Behavioral|EQ-5D-5L HRQOL results be available to the attending doctor|all subjects attending the intervention clinics will complete the electronic EQ-5D-5L before seeing the doctor during each follow-up visit for the musculoskeletal problem, a print out of the longitudinal EQ-5D-5L data (Table 1) since recruitment will be given to the patients to show to the attending doctors during the consultation. The doctors will provide the management based on the usual clinical information and the additional EQ-5D-5L HRQOL results. The doctor will complete the clinician-reported follow-up clinical data form (CRF) of each eligible patient at the end of the consultation.
15905142|NCT03609749|Behavioral|Mindfulness Training for Primary Care|"For intervention description see Mindfulness Training for Primary Care (MTPC) in the study MINDFUL-PC: Integrating Mindfulness Into the Patient-Centered Medical Home (Phase 3)"
15905143|NCT03609736|Diagnostic Test|18F-DCFPyL PET/CT|"A bolus of less than or equal to 9 mCi (333 MBq) of 18F-DCFPyL will be injected IV by slow IV push.
~After administration of the 18F-DCFPyL the line will be flushed with saline (0.9% w/v).
~Subjects should be encouraged to drink up to 500 mL of water shortly after the administration of 18F-DCFPyL.
~At 60-minutes (± 10 minutes) after administration of 18F-DCFPyL, the PET/CT scan will be acquired with the subject in the supine position and the FOV including the mid-thighs to skull base."
15905144|NCT03609723|Procedure|CABG|CABG with application of a myocardial protection system (MPS ®) and using a minimal extracorporeal circulation system (MiECC) or CABG without use of a minimal extracorporeal circulation system (Off-pump coronary artery bypass grafting = OPCABG)
15905145|NCT03609710|Device|Transanal tube placement|Transanual tube placement after anastomosis in low anterior resection for rectal cancer.
15905146|NCT03609710|Procedure|Left colic artery preservation|Left colic artery preservation during operation for lower rectal cancer
15905147|NCT03609710|Procedure|Anastomotic reinforcing sutures|Anastomotic reinforcing sutures during operation for lower rectal cancer
15905148|NCT03609710|Device|Robotic surgery|Robotic low anterior resection for rectal cancer
15905151|NCT03609684|Other|Gymnastic and Core Stabilization|People who regularly do gymnastics and also do 30-45 minutes core stabilization exercises
15905152|NCT03609684|Other|Only Gymnastic Training|People can do gymnastics twice a week but can't do core stabilization exercise
15905153|NCT03609684|Other|Sedentary Group|People who are not interested in any sports and don't do any exercises
15905154|NCT03609671|Behavioral|Standard of Care + Experimental Individualized Therapy|Participants will receive standard of care plus supportive psychotherapy for a one hour, weekly, during the time they are undergoing neoadjuvant treatments.
15905155|NCT03609671|Other|Control: Standard of Care|Participants will undergo standard of care only (no Intervention/no individualized therapy) .
15905156|NCT03609658|Behavioral|Nurse Navigator Pathway|In the Nurse Navigator Pathway, nurse navigators are being used as leverage to: approach qualified patients to initiate advance care planning discussions, schedule advance care planning visit with patients' primary care provider to further discuss advance care planning and to mail advance care planning resources to patients after their initial advance care planning discussion.
15905157|NCT03609658|Behavioral|Usual Care|In the Usual Care arm, there is no approach by nurse navigators to initiate advance care planning discussions and it does not have a structure advance care planning visit. Therefore, no further action is required for the patients who were randomly assigned to the usual care arm.
15905158|NCT03609645|Procedure|Fascia iliaca block|"FIB Placebo Block: 20mL of Normal Saline Active drug: 20mL of 0.25% Bupivacaine with epinephrine (1:400, 000)
~FAB block Placebo Block: 20mL of Normal Saline Active Drug: 20mL of 0.25% Bupivacaine with epinephrine (1:400,000)"
15905159|NCT03609645|Procedure|Femoral articular branches block(FAB)|"FIB Placebo Block: 20mL of Normal Saline Active drug: 20mL of 0.25% Bupivacaine with epinephrine (1:400, 000)
~FAB block Placebo Block: 20mL of Normal Saline Active Drug: 20mL of 0.25% Bupivacaine with epinephrine (1:400,000)"
15905160|NCT03609632|Other|Dietary Supplement: Glucose|Intake of 75g of glucose with 1g of 13C leucine pre-feeding
15905161|NCT03609619|Drug|AEVI-001|Oral doses of 100 mg, 200 mg or 400 mg of AEVI-001 will be administered twice daily, during the treatment period.
15905162|NCT03609619|Drug|Placebo|Oral doses of Placebo will be administered twice daily, during the treatment period.
15905163|NCT03609606|Drug|D013, D326 and D337|Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days
15905164|NCT03609606|Drug|D013|Daily oral administration of 1 tablet under fasting conditions for 7 days
15905165|NCT03609606|Drug|D326 and D337|Daily oral administration of 1 tablet for each drug under fasting conditions for 7 days
15905643|NCT03605914|Drug|diclofenac|The non-steroidal anti-inflammatory drug (NSAID) used in this study is diclofenac.
15905166|NCT03609593|Drug|Bendamustine|Subjects will receive Bendamustine 50-90 mg/m2 on days 1-2 for three cycles with each cycle being 28 days.
15905167|NCT03609593|Drug|Venetoclax|"Venetoclax: 12 cycles
~Venetoclax will then be started after 3 cycles of BR. Dosing for venetoclax will be in a step wise fashion as follows:
~Cycle 4 days 1-7 (Week 1): 20 mg once daily
~Cycle 4 days 8-14 (Week 2): 50 mg once daily
~Cycle 4 days 15-21 (Week 3): 100 mg once daily
~Cycle 4 days 22-28 (Week 4): 200 mg once daily
~Cycle 4 day 29 and thereafter (Week 5 and on): 400 mg once daily; continue until disease progression, unacceptable toxicity, or 12 cycles duration."
15905168|NCT03609593|Drug|Rituximab|For cycles 1 through 3, subjects will receive BR on days 1 and 2. For cycles 5-10, subjects will receive rituximab monotherapy at 375 mg/m2 (cycle 5) or rituximab at 500 mg/m2 (cycles 6-10) on day 1 (or days 1 and 2 if split-dose).
15905169|NCT03609580|Drug|Tamsulosin|The investigators hypothesize that pre-operative administration of Tamusolin (Flomax, 0.4mg/day x 1 week), with ongoing use post-operatively until normal voiding resumes, will result in a significant decrease in the incidence of POUR after a thoracic surgical procedure.
15905170|NCT03609567|Other|Aromatherapy|Aromatherapy using essential oils
15905171|NCT03609567|Other|Placebo|Aromatherapy using odorless placebo oil
15905172|NCT03609554|Other|Pilates|The Pilates exercise programme was implemented over 6 weeks, with 2 sessions/week (55 minutes/session). The Pilates programme was conducted by the Physical Education teacher, who was certified in Pilates training. The Pilates programme began at the basic level, incorporating more difficult principles and exercises gradually. The sessions were divided into the warm-up (7 min), the main part (41 min), and the cool down (7 min). Tt concentrated on basic Pilates exercises involving the principal regions of the body (spine flexions, extensions and rotations; hip flexions, extensions and rotations; and shoulder abductions, adductions and rotations).
15905173|NCT03609528|Device|CamPROBE|To be completed
15905174|NCT03609515|Other|Patient-controlled admission|The patients with a contract for patient-controlled admissions may refer themselves to short inpatient stays when they feel the need, without needing an approval from a clinician. They will be accepted for admission if a patient-controlled bed is available in the ward. Patient-controlled admissions are limited to a length of 5 days and at least three weeks between such stays.
15905175|NCT03609502|Behavioral|behavioral training|the participants will be trained to perceive a non-native speech contrast
15905176|NCT03609489|Drug|Capecitabine|Capecitabine, 1000mg/m2, oral administration, twice daily (once in the morning and once in the evening with an interval of 12 hours, equivalent to a total daily dose of 2000 mg/m2), continuous medication for 14 days and off for 7 days. Every 21 days is a cycle, and there shall be a total of 8 cycles. If the subject is still unable to tolerate toxicity after experiencing two dose adjustments, he/she should be moved out of the group.
15905177|NCT03609489|Drug|Apatinib|Apatinib, 500 mg, administered orally (after breakfast) once daily from day 1 to day 21 (including day 21) with continuous administration. Every 21 days serve as a cycle. If after 2 dose adjustments, the subject is still unable to tolerate toxicity, he/she should be moved out of the group.
15905178|NCT03609476|Procedure|Room temperature saline instillation|Saline is used as room temperature
15905179|NCT03609476|Procedure|Warmed saline instillation|Saline is warmed to 37Celcius prior to instillation
15905180|NCT03609476|Procedure|No saline instillation|No saline is used prior to catheter removal
15905181|NCT03609463|Behavioral|Small change intervention|The small change intervention is a behavioral intervention to help people gradually lose weight by making small changes in their lifestyle. At the beginning of the intervention participants will be met in person to be guided in setting an eating and a physical activity goal. Participants will be then contacted through the phone or met in person weekly for 3 months to check on their adherence to the selected goals and to discuss about facilitators and barriers to goal completion, in order to increase their motivation and problem solving skills. Every weekly contact will last about an hour and will be administered in an individual setting. At each contact selected goals can be revised, changed or another goal can be added based on levels of adherence.
15905182|NCT03609463|Behavioral|Well-being intervention|The well-being intervention is a coaching intervention aimed at motivating people in making lifestyle changes by reducing levels of stress through the promotion of psychological well-being. It will consists in 4 weekly sessions to be held before starting the small change intervention. Each session will last about an hour and will be administered in an individual setting.
15905183|NCT03609463|Other|Treatment as usual|The treatment as usual includes any recommendation given to the participants by their physicians, including diet, physical activity, medication and glycemic control instructions.
15905184|NCT03609450|Behavioral|Mindfulness Training for Primary Care|MTPC is a referral-based, insurance-reimbursable 8-week program delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action plan during Week 7. Participants are called every two weeks for the first eight weeks for 5-10 minute engagement calls which focus helping participants cultivate a relationship with study staff, giving participants a place to ask questions, and supporting participants in completing study visits.
15905185|NCT03609450|Behavioral|Low-Dose Comparator|Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, and discussion. They are also given a list of leading community, online, print, and smartphone mindfulness resources. Participants are called every two weeks for the first eight weeks for 5-10 minute engagement calls which focus helping participants cultivate a relationship with study staff, giving participants a place to ask questions, and supporting participants in completing study visits.
15905186|NCT03609424|Drug|PDR001, Imatinib|"-Phase Ib part
~: The standard 3+3 dose escalation scheme will be applied. DLTs will be evaluated during the first cycle (4 weeks).
~PDR001 400mg, every 4 weeks, IV
~Imatinib dose level -1 : 200mg, PO, QD Imatinib dose level 1 : 300mg, PO, QD Imatinib dose level 2 : 400mg, PO, QD
~-Phase II part
~Recommended dose defined in phase Ib part will be tested"
15905187|NCT03609411|Procedure|Splenectomy|Splenectomy was performed after hepatectomy, in an extra-hilar manner with manual ligation of splenic vessels.
15905188|NCT03609398|Biological|RVF Vaccine|1.0 mL dose given SQ in upper arm
15905189|NCT03609385|Diagnostic Test|Coronary angiography|In patients eligible for participation in the study coronary angiography, echocardiography and EKG will be performed systematically.
15905190|NCT03609372|Behavioral|The STOP-HPV Trial 6: Maintenance|In this period, study team support will be withdrawn after previous bundled intervention (including HPV vaccine communication, performance feedback and provider prompts) was given to reduce MOs and increase HPV vaccination rates.
15905191|NCT03609359|Drug|Lenvatinib|Lenvatinib will be administered with water orally once a day (with or without food) in 21-day cycles at approximately the same time each day. On Day 1 of each cycle, in case concomitantly administered, it will be administered approximately within 1 hour after completion of pembrolizumab administration.
15905192|NCT03609359|Drug|Pembrolizumab|Pembrolizumab will be administered as a dose of 200 mg as a 30-minute IV infusion, Q3W (25 minutes to 40 minutes are acceptable).
15905193|NCT03609346|Device|PCI|The placement of 1 or more stents in the diseased coronary artery lesion(s).
15905194|NCT03609333|Device|Multimodal Neuromonitoring|Application of multimodal neuromonitoring
15905195|NCT03609320|Behavioral|The STOP-HPV Trial 5: Bundle Intervention|This intervention will implement a 3-component bundle intervention (communication skills training, performance feedback and prompts) together in practices that previously received standard of care.
15905196|NCT03609307|Drug|Combined Intravitreal bevacizumab and propranolol|these patients receive two injections at each session Bavacizumab and propranolol
15905197|NCT03609307|Drug|Intravitreal bevacizumab|these patients receive only Bevacizumab
15905198|NCT03609294|Drug|Treatment A (Fimasartan, Linagliptin)|Co-administration of Fimasartan and Linagliptin
15905199|NCT03609294|Drug|Treatment B (Fimasartan/Linagliptin)|Fixed Dose Combination of Fimasartan 120 mg/Linagliptin 5 mg
15905200|NCT03609281|Radiation|Ultrasound assessement of uterine scar|3D ultrasound assessment of scar characteristics
15905201|NCT03609268|Device|microwave ablation (MWA)|microwave ablation (MWA) for recurrent small liver cancer
15905202|NCT03609268|Radiation|stereotactic body radiotherapy (SBRT)|stereotactic body radiotherapy (SBRT) for recurrent small liver cancer
15905203|NCT03609255|Behavioral|Reducing sedentary behavior|Educational handouts for sedentary behavior and strategies reducing sedentary behavior and weekly videos related to reduced sedentary behavior
15905204|NCT03609255|Behavioral|Reducing stress|Educational handouts for sedentary behavior and stress management handout and weekly videos related stress management
15905205|NCT03609255|Behavioral|Control|An educational handout for sedentary behavior and weekly neutral topic videos
15905206|NCT03609242|Behavioral|STOP-HPV bundle intervention|This intervention will be the bundle (training in communication skills, with the addition of performance feedback followed by the addition of provider prompts).
15905207|NCT03609229|Procedure|Burch|polyglactin suture was passed through the Cooper's ligament bilaterally with the guidance of the valve
15905208|NCT03609229|Procedure|Abdominal Sacrocolpopexy|"By careful dissection (to avoid large veins in this region), expose the back of the pubic bone and the lateral aspects of the urethra.
~The right-handed operator double gloves, and places the left hand in the vagina.
~With fingers on either side of the catheter in the vagina, define the urethrovesical junction (at the balloon).
~Place three Ethibond J-shaped sutures on either side of the urethrovesical junction."
15905209|NCT03609216|Drug|Gemcitabine Hydrochloride|Given IV
15905210|NCT03609216|Drug|Cisplatin|Given IV
15905211|NCT03609216|Biological|Pegfilgrastim|Given SC
15905212|NCT03609216|Procedure|Conventional Surgery|Undergo bladder sparing
15905213|NCT03609216|Procedure|Radical Cystectomy|Undergo radical cystectomy
15905214|NCT03609216|Other|Chemoradiotherapy|Undergo chemoradiotherapy
15905215|NCT03609203|Other|10 Weeks of Strength Trailing|"Week 1 (pre training session): self efficacy survey; 5-point frailty assessment*; diet survey; metabolic assessment; Functional status and body composition; blood and stool sample
~Week 5: self efficacy survey; Functional status and body composition
~Week 10: self efficacy survey; 5-point frailty assessment*; diet survey; metabolic assessment; Functional status and body composition; blood and stool samples"
15905216|NCT03609203|Other|Group Nutrition Discussion: week 1, week 5 and week 10|"Week 1 (pre training session): self efficacy survey; 5-point frailty assessment*; diet survey; metabolic assessment; Functional status and body composition; blood and stool sample
~Week 5: self efficacy survey; Functional status and body composition
~Week 10: self efficacy survey; 5-point frailty assessment*; diet survey; metabolic assessment; Functional status and body composition; blood and stool samples"
15905217|NCT03609190|Drug|Ketamine|i.v. infusion of 0.25 mg/kg S-ketamine over 40 min
15905218|NCT03609190|Drug|Placebo|i.v. infusion of NaCl over 40 min
15905219|NCT03609177|Other|Clinician Communication Skills Training|Communication skills training
15905220|NCT03609177|Other|Advance Care Planning (ACP) Decisions Videos Decisions Aids|ACP Decisions video decision aids
15905221|NCT03609177|Other|Video Declarations (ViDec)|Recording of patient advance care planning videos
15905222|NCT03609164|Procedure|Suture-bridge augmentation of single-row repair|
15905223|NCT03609151|Procedure|laparoscopic hepatectomy (surgery)|Patients receive laparoscopic hepatectomy.
15905224|NCT03609151|Radiation|stereotactic body radiotherapy|Patients receive stereotactic body radiotherapy(SBRT)
15905225|NCT03609138|Device|Spinal Hardware|Pedicle screws and patient specific rods
15905226|NCT03609125|Other|CBS eyedrop|The product is dispensed as sterile frozen vials containing 0.8 ml of product for the daily administration. The product is thawed and administered at a dose of 1 drop / 8 times each eye during the waking period.
15905227|NCT03609112|Other|The WISC-IV|"The WISC-IV (Weschler, 2003) which is measured with several indices:
~A Verbal Understanding Index (VUI), which comprehensively assesses the child's verbal skills
~Perceptual reasoning index (PRI), which assesses isuoperceptive and visuo-practical capacities
~An index of working memory (IWM), which assesses the child's ability to do several things at the same time (double-tasks)
~A rate of treatment index (RTI) that assesses grapho-motor speed"
15905228|NCT03609112|Other|The CMS (CHILD MEMORY SCALE)|It is an evaluation scale of episodic memory with an immediate recall (after reading the story to remember) and a delayed recall (25-35 min after)
15905229|NCT03609112|Other|CONNERS|"The CONNERS which allows the assessment of attentional skills through a questionnaire that will be completed by parents"
15905230|NCT03609112|Other|BRIEF|"The BRIEF which is an inventory of behavioral evaluation of executive functions completed by parents and which makes it possible to determine if the child has, for example, difficulties of organization, planning or behavioral regulation."
15905231|NCT03609112|Other|PEDS-QL|"The PEDS-QL quality of life that will be completed by the parents and the patient concerns the day-to-day functioning of the child (in school, relationships to others, physical abilities and emotional state)"
15905232|NCT03609112|Other|State Trait Anxiety Inventory|The State Trait Anxiety Inventory (STAI), which assesses the anxiety of the child (trait and situational anxiety).
15905233|NCT03609112|Other|Child Depression Inventory|The Child Depression Inventory (CDI) assessing any signs of depression in the child.
15905234|NCT03609099|Drug|Moxifloxacin|400 mg / day once a day oral treatment during 3 days.
15905235|NCT03609099|Drug|Placebo|once a day oral treatment during 3 days.
15905236|NCT03609086|Other|Melatonin analysis|Measurement of 6-hydroxymelatonin
15905237|NCT03609073|Device|Endomina|Suturing system then cutting the bridge between the diverticulum and the esophagus.
15905238|NCT03609060|Drug|Dexamethasone|Dexamethasone 10 mg/12h, IV over 30 minutes, D1 to D3 concomitant to induction and post remission chemotherapy in elderly patients with AML Induction
15905239|NCT03609047|Drug|Palbociclib|CDK4/6 inhibitor
15905240|NCT03609047|Drug|Docetaxel / cyclophosphamide|Adjuvant Chemotherapy
15905241|NCT03609047|Drug|doxorubicin/cyclophosphamide|Adjuvant Chemotherapy
15905242|NCT03609047|Drug|epirubicin/cyclophosphamide|Adjuvant Chemotherapy
15905243|NCT03609047|Drug|paclitaxel|Adjuvant Chemotherapy
15905244|NCT03609021|Procedure|Screening Mammography|Provide bilateral mammogram
15905245|NCT03609021|Procedure|Biospecimen Collection|Undergo collection of blood sample
15905246|NCT03609008|Drug|Levcromakalim|Intravenous administration of levcromakalim or placebo for 20 minutes. To investigate the role of levcromakalim/placebo on cerebral hemodynamic in healthy volunteers.
15905247|NCT03609008|Drug|Saline|Intravenous administration of levcromakalim or placebo for 20 minutes. To investigate the role of levcromakalim/placebo on cerebral hemodynamic in healthy volunteers.
15905248|NCT03608995|Diagnostic Test|Premaquick (Diagnostic test)|"PREMAQUICK® is a rapid multiparametric test which aim to detect the presence of IGFBP-1 (Insulin-like Growth Factor-Binding Protein 1), fragmented IGFBP-1 and IL-6 (Interleukin 6) in vaginal secretions. By combining biomarkers of myometrial activation, cervical maturity and inflammation / infection, PREMAQUICK® integrates the main pathogenic mechanisms responsible for premature delivery, which makes it possible to predict or, on the contrary, rule out the risk of childbirth within 7 to 14 days. This test is intended for in vitro diagnostic use.
~Vaginal secretions are collected under speculum with a swab (10 seconds of impregnation of the swab). The swab is immersed in a tube containing an extraction buffer for 10 seconds. The tube is mixed and then 3 drops are deposited in each wells of the test device for 10 minutes. Visual reading should be done between 10 and 15 minutes."
15905249|NCT03608995|Diagnostic Test|Quikcheck fFN ™|- The Hologic QuikCheck fFN test is intended to be used for the qualitative detection of fetal fibronectin in cervicovaginal secretions. The presence of fetal fibronectin in cervicovaginal secretions between 22 weeks, 0 days and 34 weeks, 6 days of gestation is associated with elevated risk of preterm delivery. Quick Check fFN test® is a 10 min, one-step, visual test consists of a sterile polyester-tipped applicator, fetal fibronectin test strip, and sample extraction buffer. The QuikCheck fFN is a solid-phase immunogold assay which aim to detect fetal fibronectin. A positive specimen will result in two visible lines and a negative specimen will result in one visible line (control).
15905250|NCT03608982|Other|Simulated patient|The simulated patient is a professional actor and Belgian Red Cross employee, who combines acting distress and pain with moulage, to mimic the injuries as truthfully as possible. For feasibility reasons, the simulant will only be included in two sections of the course: the respective treatments of burns and stroke. The remainder of the course will be taught without simulated patient by the professional first aid tutors.
15905251|NCT03608982|Other|No simulated patient|Instead of a simulated patients, participants get to watch video clips on first aid techniques.
15905252|NCT03608969|Other|NOT-S|Participants are assessed for the orofacial function using the Nordic Orofacial test- screening (NOT-S), Gross Motor Function Classification System (GMFCS), Manual Ability Classification System (MACS) and Communication Function Scale (CFS). Oral health related quality of life is assessed using the Parental- Caregiver Perceptions Questionnaire (P-CPQ). Caries experience was measured by identifying decayed, missing, and filled teeth for deciduous and permanent teeth (dmft). Gingival index and type of occlusion will be recorded.
15905253|NCT03608943|Other|There is no specific intervention other than an individual changing their treatment as part of their usual care|There is no specific intervention other than an individual changing their treatment as part of their usual care
15905254|NCT03608930|Device|Disposable Polypectomy Snare,JHY-SD-23-230-30-A1|The technique is hot snare resection of the polyp with electrocautery. Details are as follows: (1) insert the snare into the colonoscopy; (2) connect the snare with the high-frequency device;(3) advance sliding handle to open the loop; (4) adjust the direction of the snare by rotating the handle as required, rotate the loop until the loop reaches target polyp; (6) encircle the target polyp with loop; (7) pull the sliding handle, lasso the target polyp;(8) resect the polyp with electrocautery, then inhaling the transected polyp into a trap followed by submission to the histological evaluation.
15905255|NCT03608917|Drug|Total Glucosides of Paeony(TGP)|Total Glucosides of Paeony(TGP) as a traditional Chinese medicine, peony root is the dried root of peony of Ranunculaceae, cultivated all over the country.TGP is new drug of western medicine, original discovered by Professor Xu who is a famous pharmacologist. The main ingredient is a group of glycosides, including paeoniflorin, hydroxy paeoniflorin, paeoniflorin, paeoniflorin, benzoyl paeoniflorin etc, collectively referred to as total glucosides of paeony（TGP）
15905256|NCT03608917|Device|Narrow band-ultraviolet b（NB-UVB）|phototherapy on treating vitiligo
15905257|NCT03608917|Drug|Total Glucosides of Paeony(TGP) analogue|Total Glucosides of Paeony(TGP) analogue as a placebo for Control group
15905258|NCT03608904|Other|Music listening|Familiar and unfamiliar music selections, listening duration of approximately 15 minutes, three times daily, 90-day listening duration.
15905259|NCT03608904|Other|Spoken word (language) listening|Familiar and unfamiliar spoken word (language) selections, listening duration of approximately 15 minutes, three times daily, 90-day listening duration.
15905260|NCT03608891|Device|Computer guided patient specific 3D titanium plate|CBCT or CT scan will be done preoperatively and dicom files will be imported to mimics software to design and print the patient specific 3D titanium plate.
15905261|NCT03608891|Device|Conventional titanium miniplates|In this group two miniplates of titanium Mini-System 2.0 mm will be used. The plate has profile height 1.0 mm whereas the screw length varies according to the site of the plate. According to Champy osteosynthesis lines for fixation of the posterior mandibular fracture ,the first plate will be placed at the inferior border from the buccal side, using bicortical screws engaging the buccal and lingual cortices to achieve rigid fixation, while the second plate will be placed at about 5mm superior to the inferior plate in the subapical region, using monocortical screws engaging only the buccal cortex to avoid injuring the teeth roots.
15905262|NCT03608878|Biological|adagloxad simolenin/OBI-821|"Adagloxad simolenin (OBI-822) is a glyco-conjugated protein comprised of a carbohydrate tumor antigen. Globo H allyl glycoside is covalently linked to a carrier protein KLH, presented in a dominant trimer form with molecular weight between 1200-1395 kDa., to form Adagloxad simolenin (OBI-822) (Globo H-KLH) OBI-821 is a saponin based adjuvant structurally similar to descriptions found in the literature for another adjuvant, QS-21.
~Adagloxad simolenin will be mixed with OBI-821 before administration."
15905263|NCT03608878|Procedure|TACE|Transarterial chemoembolization
15905264|NCT03608865|Drug|Durvalumab with Tremelimumab|Trial treatment should be administered on Day 1 of each cycle after all procedures/assessments have been completed as detailed on the Trial Flow Chart. Trial treatment may be administered up to 3 days before or after the scheduled Day 1 of each cycle due to administrative reasons. All trial treatments will be administered on an outpatient basis. Durvalumab 1500mg + tremelimumab 750 mg will be administered as a 60 minute each one IV infusion every 4 weeks. Sites should make every effort to target infusion timing to be as close to 60 minutes as possible. However, given the variability of infusion pumps from site to site.
15905265|NCT03608839|Drug|Intravitreous Dexamethasone Solution 4mg/ml - vol 0,01 ml|0,01 ml intravitreous dexamethasone solution 4mg/ml injection.
15905266|NCT03608839|Drug|Intravitreous Dexamethasone Solution 4mg/ml - vol 0,03 ml|0,03 ml intravitreous dexamethasone solution 4mg/ml injection.
15905267|NCT03608839|Drug|Intravitreous Dexamethasone Solution 4mg/ml - vol 0,05 ml|0,05 ml intravitreous dexamethasone solution 4mg/ml injection.
15905268|NCT03608826|Device|Investigational LINQ™ HF RAMware|The Reveal LINQ™ device and the 2090 programmer are market-released, but once the investigational LINQ™ HF RAMware is downloaded into the devices, they are considered investigational.
15905269|NCT03608813|Other|Serum Metabolomics profiling|Untargeted serum metabolomics profiling
15905270|NCT03608800|Behavioral|Intermittent fasting|The intervention of two nonconsecutive days of 75% energy restriction per week for 8 weeks
15905271|NCT03608787|Behavioral|S-STOP|Pseudo-intoxicated patrons will enter each participating establishment and attempt to be served an alcoholic beverage. In the intervention phases, feedback on staff performance will be provided to owners/managers along with supporting materials and a link to a website with a video of a typical pseudo-intoxicated patron. Staff will be provided with a link to a website providing tips for preventing overservice.
15905272|NCT03608774|Drug|Azithromycin|Azithromycin monohydrate is a macrolide antibacterial drug, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) in dose 1 gram (4 capsules of 250 mg), administered orally as a single dose.
15905273|NCT03608774|Drug|Doxycycline|Doxycycline hyclate is an antibacterial drug synthetically derived from oxytetracycline, FDA-approved in the US for the treatment of Chlamydia trachomatis (CT) as a course of 100 mg (1 capsule), administered orally twice daily for 7 days.
15905274|NCT03608774|Other|Placebo|Azithromycin placebo (4 capsules), administered orally as a single dose; Doxycycline placebo (1 capsule), administered orally twice daily for 7 days.
15905275|NCT03608761|Drug|Rebamipide|rebamipide 2%
15905276|NCT03608761|Biological|autologous serum|AS for 3 months
15905277|NCT03608761|Other|autologous serum and rebamipide 2%|rebamipide and autologous serum for 3 months
15905278|NCT03608722|Other|SLUMS|A pen and paper screening tool of cognitive impairment
15905279|NCT03608722|Other|MMSE|A pen and paper screening tool of cognitive impairment
15905280|NCT03608722|Other|MoCA|A pen and paper screening tool for cognitive impairment
15905281|NCT03608722|Device|BrainCheck|A computerized neurocognitive test administered via an electronic device, such as a phone, tablet or computer, that contains several assessments that will aid in establishing an individuals cognitive performance
15905282|NCT03608696|Drug|Buprenorphine|buprenorphine 0.075 mg/ml solution
15905283|NCT03608670|Device|Defibrillation using the Extravascular ICD|VT/VF induction attempted for defibrillation testing, as well as requisite electrical testing.
15905284|NCT03608657|Drug|Apremilast|Apremilast
15905285|NCT03608631|Drug|Mesenchymal Stromal Cells-derived Exosomes with KRAS G12D siRNA|Given IV
15905286|NCT03608618|Biological|MCY-M11|Intraperitoneal administration
15905287|NCT03608618|Drug|Cyclophosphamide|Intravenous administration for preconditioning
15905288|NCT03608605|Device|MRI|magnetic resonance imaging with advanced sequences including tractography,volumetry and inversion recovery
15905289|NCT03608592|Biological|umbilical cord derived mesenchymal stem cells (UCMSCs) suspension|Clinical grade human umbilical cord derived mesenchymal stem cells (passage 3-5) suspension are provided by biotherapy center of the third affiliated hospital of Sun Yat Sen University. Cells are made of suspension packages (60million cells in 100ml normal saline per bag) and infused intravenously in 2 hours.
15905290|NCT03608592|Biological|normal saline|A bag of 100ml clinical grade normal saline are also provided by biotherapy center of the third affiliated hospital of Sun Yat Sen University.
15905291|NCT03608579|Drug|Autologous Adipose Derived Mesenchymal Stromal Cells|Human, autologous, culture expanded, adipose derived, mesenchymal stromal cells (AMSCs) produced on site in the Mayo Clinic Human Cellular Therapy Laboratory using current good manufacturing practices
15905292|NCT03608553|Device|MR Guided Focused Ultrasound|Blood Brain Barrier Disruption using FUS
15905293|NCT03608540|Device|Endomina|Suturing system with sutures apposition then bulging then cutting
15905334|NCT03608215|Device|Active tDCS|The anode and cathode sponge electrode (51 cm2) will be placed over C3 and FP2 (10-20 system) respectively. 2 mA current will be applied continuously for 20 minutes.
15905809|NCT03604484|Procedure|Tricuspid annuloplasty|Tricuspid annuloplasty
15905294|NCT03608527|Behavioral|Voluntary-based upper limb motor rehabilitation|Exercises for neuromuscular control to improve proprioceptive sensibility, muscle strength, stability and coordination of the upper limbs, mainly including task-oriented movements with the goal to improve activities of daily living. Both proximal and distal muscles are involved, in actions such as grasping wooden cubes of different sizes, pinching, reaching targets displayed in front of the patient, and doing patchwork or paper mandala.
15905295|NCT03608527|Behavioral|Passive upper limb mobilization|Passive mobilization delivered by a physical therapist of shoulder, elbow, wrist and fingers without detectable muscle activity.
15905296|NCT03608514|Drug|Experimental|Patients in this arm of the study will receive intravenous infusion (IVi) terlipressin by rate 1-2µg/kg/min.
15905297|NCT03608501|Drug|Ixazomib|Ixazomib capsules.
15905298|NCT03608501|Drug|Thalidomide|Thalidomide capsules.
15905299|NCT03608501|Drug|Dexamethasone|Dexamethasone tablets.
15905300|NCT03608488|Dietary Supplement|Vitamin D|Vitamin D3 50.000 IU/per week, for 8 weeks
15905301|NCT03608488|Other|Exercise|Core stability, balance exercises
15905302|NCT03608475|Other|Limited Ultrasound Imaging|Ultrasound imaging will not be performed at the 2, 5 and 8 week clinic visits
15905303|NCT03608475|Other|Standard Ultrasound Imaging|Ultrasound imaging will be performed at all clinic visits
15905304|NCT03608462|Device|repetitive transcranial magnetic stimulation(DLPFC)|high frequency(20Hz) repetitive transcranial magnetic stimulation on dorsolateral prefrontal cortex(DLPFC) .Duration:10 days.
15905305|NCT03608462|Device|repetitive transcranial magnetic stimulation(LPC)|high frequency(20Hz) repetitive transcranial magnetic stimulation on left parietal cortex(LPC).Duration:10 days
15905306|NCT03608449|Other|questionnaires|questionnaire about mental health status during psychotherapy
15905309|NCT03608423|Device|Minimally-invasive endoscopy-guided surgery|Surgery started within 8 hours of onset of spontaneous intracerebral hemorrhage.
15905310|NCT03608410|Other|Weekly Internet based PRO questionnaires|If core symptoms worsen and exceeds a predefined threshold, a PRO-notification is sent to the hospital.
15905311|NCT03608397|Biological|DaxibotulinumtoxinA for injection|DaxibotulinumtoxinA for injection is a sterile, white to off-white lyophilized product containing the active ingredient, daxibotulinumtoxinA, and inactive ingredients to be reconstituted with sterile, non-preserved, 0.9% sodium chloride solution saline.
15905312|NCT03608397|Biological|Placebo|Placebo is a sterile lyophilized product consisting of inactive ingredients without the neurotoxin to be reconstituted with sterile, non-preserved 0.9% sodium chloride solution.
15905313|NCT03608371|Drug|BTRX-246040|oral capsule 40 mg
15905314|NCT03608371|Drug|Placebo|oral capsule matching BTRX-246040 40 mg capsule
15905315|NCT03608358|Drug|Dapagliflozin 10 mg|10 mg, oral tablet, once daily for 24 weeks of double-blind treatment period
15905316|NCT03608358|Drug|Dapagliflozin 5 mg|5 mg, oral tablet, once daily for 24 weeks of double-blind treatment period
15905317|NCT03608358|Drug|Dapagliflozin 10 mg placebo to match|10 mg, oral tablet, once daily for 24 weeks of double-blind treatment period
15905318|NCT03608358|Drug|Dapagliflozin 5 mg placebo to match|5 mg, oral tablet, once daily for 24 weeks of double-blind treatment period
15905319|NCT03608358|Drug|Saxagliptin 5 mg|5 mg, oral tablet, once daily for 24 weeks of double-blinded treatment period, and for 16 weeks of open-label treatment period in Stratum A or 8 weeks of open-label treatment period in Stratum B
15905320|NCT03608358|Drug|Metformin|Stable dose of metformin immediate release/extended release (≥ 1500 mg/day or at a maximal tolerated dose) throughout the whole study period
15905321|NCT03608345|Other|space maintainer|Space maintainers are applied after the missing teeth in pediatric dentistry for protection of size of extracted area.
15905322|NCT03608332|Device|diaphragmatic ultrasound|Diaphragmatic excursion; Diaphragmatic movement will be measured with a 3.5-MHz US probe (Mindray machine, DC-N6).
15905323|NCT03608319|Drug|A4250|9.6 mg
15905324|NCT03608306|Other|Resin-modified glass ionomer|enhanced RMGIs with an ionic resin matrix, a shock-absorbing resin component, and bioactive fillers that mimic the physical and chemical properties of natural teeth.
15905325|NCT03608306|Other|Bulk-fill glass hybrid restorative|It's a bulk-fill, fluoride-releasing restorative system that combines EQUIA Forte Fil, which is a high strength glass hybrid restorative, and EQUIA Forte Coat, a wear-resistant, self-adhesive, light-cured resin coating.
15905326|NCT03608293|Diagnostic Test|Broncho Alveolar Lavages (BAL)|BEAS-2 B cells are exposed to EVs isolated from BAL of smokers and non-smokers.
15905327|NCT03608280|Procedure|Bone autograft|The principle of this surgery is based on the removal of a portion of the outer bone layer from the vault of the skull in order to have a flat and solid bone element (cortical bone), which can be carved freehand to better replace the defective bone wall.
15905328|NCT03608280|Procedure|Orbital reconstruction by 3D-printed porous titanium implant|"From data of a patient's CT-scan, it is possible to perform a mirroring. The unaffected orbit is mirrored onto the affected orbit, via a virtual treatment planning, in order to rely on facial symmetry to virtually restore healthy anatomy. From this simulation, the implant is 3D-printed by Selective Laser Melted (SLM) technique using titanium powder. This technique enabling the creation of custom-made implants is called computer-aided design and computer-aided manufacturing (CAD-CAM).
~After sterilization, the implant is ready to be placed during a surgical procedure."
15905329|NCT03608267|Device|Endomina|The jejunum between the two loops is sutered with Endomina and cut 15 days later.
15905330|NCT03608254|Other|100% watermelon juice|Participants consumed a one-time dose of 100% watermelon juice. Blood was sampled before and 2 hours after ingestion. Blood pressure and brachial artery flow-mediated dilation were measured before and 2 hours after ingestion.
15905331|NCT03608241|Drug|PF-06651600|200 mg by mouth (PO) Once daily (QD) for 11 days
15905332|NCT03608241|Drug|Ethinyl estradiol (EE) and levonogestrel (LN)|Single dose of Oral tablet containing 30 ug EE and 150 ug of LN
15905333|NCT03608228|Other|Measuring electrical signals from the brain|If patients participate in this study, after the deep brain stimulator leads have been implanted, the researcher(s) will plan to measure electrical signals from the brain while patients perform hand movement tasks.
15905335|NCT03608215|Device|Sham tDCS|The anode and cathode sponge electrode (51 cm2) will be placed over C3 and FP2 (10-20 system) respectively. 2 mA current will be applied for 30 seconds at the beginning.
15905336|NCT03608202|Behavioral|POCUS protocol group|"The findings of multiorgan ultrasound can modify diagnoses and treatments and immediate interventions (eg volume loading with saline solution, pleural or pericardial drainage, initiation of diuretics, increase in positive end expiratory pressure, etc.).
~This protocol is performed in the first 24 h of admission to the Intensive Care Unit (ICU) and is repeated at 24 h."
15905337|NCT03608202|Other|Control group|Routine protocol of the treating team is followed
15905338|NCT03608176|Other|PASO diet group|This group include a low-fat, low calorie diet (1200-1800 kcal), in addition of a behavioral change protocol. They will also be instructed to consume green tea (2 cups/day for 3 days/week), black tea (2 cups/day for 2 days/week), coffee (2 cups/day for 2 days/week), cinnamon (1 tsp/day for at least 3 days/week), psyllium fiber (3 tsp/day/week) and water (1.5 L/day/week).
15905339|NCT03608176|Other|Low-fat diet group|This group include a low-fat, low calorie diet (1200-1800 kcal), in addition of a behavioral change protocol.
15905340|NCT03608176|Other|Waiting list group|This group will only receive written information with recommendations on healthy eating. When the study finished, this group will receive a behavioral change protocol with a low-fat, low calorie diet.
15905341|NCT03608163|Drug|Naloxone|Naloxone Nasal Spray
15905342|NCT03608163|Drug|Diazoxide|Diazoxide (oral)
15905343|NCT03608163|Drug|Placebo (for Naloxone)|Sterile water nasal spray
15905344|NCT03608163|Drug|Placebo (for Diazoxide)|Taste matched oral placebo for diazoxide
15905345|NCT03608150|Device|Luminopia One|Luminopia One is a virtual-reality based digital therapeutic that applies therapeutic modifications in real-time to cinematic content to rebalance visual input and treat amblyopia.
15905346|NCT03608150|Device|Refractive Correction|Standard of care refractive correction (ex. spectacles)
15905347|NCT03608137|Other|Cannabis and thought disorder in schizophrenia:clinical and neuroimaging relationships|To investigate whether the level of cannabis use in schizophrenic patients influences the symptoms of psychic disorganization via modulation of cerebral connectivity between the temporal lobe and the putamen.
15905348|NCT03608124|Behavioral|Behavior management techniques|Pediatric dentists will be questionnaired regarding their adopted behavior management techniques for pediatric patients
15905349|NCT03608111|Other|single task balance training|single task balance training
15905350|NCT03608111|Other|dual task balance training|dual task balance training
15905351|NCT03608098|Device|Short Pulse Duration|The holmium laser device will be used on a short laser pulse duration setting (300 μs or 350 μs)
15905352|NCT03608098|Device|Long Pulse Duration|The holmuim laser device will be used on a long laser pulse duration setting (700 μs or 1500 μs)
15905353|NCT03608085|Behavioral|Pharmacist Heart failure MTM training|"The MTM training for pharmacists will consist of:
~Online material for home self-study (10 contact hours);
~Didactic coursework to obtain a national American Pharmaceutical Association (APhA) MTM certification (8 contact hours); and HF pharmacotherapy (4 contact hours);
~1 60-minute sessions of point of care training in the community pharmacy practice lab setting by URI faculty;
~Monthly coaching conference calls/webinars with URI and Brown Faculty;"
15905354|NCT03608085|Behavioral|Patient Heart failure MTM intervention|"The baseline visit will take place >= 7 but <= 30 days post discharge from the HF hospitalization. Follow-up visits will occur either in person at the patients local pharmacy or via telephone at 30, 60, 90 and 120 days post baseline and will consist of the following:
~Preparation: Develop personal medication record (PMR). Assessment: Medication therapy reconciliation; Education: Review heart failure basics and behavioral goals Planning: Documentation of a medication related action plan and identify medication related problems Implementation: Communication of medication related action plan and changes in heart failure symptoms to the patients providers.
~Follow up: Monitor and evaluate the care plan in collaboration with the patient's providers."
15905355|NCT03608072|Drug|BI 690517|3 sequential dose groups
15905356|NCT03608072|Drug|Placebo|3 sequential dose groups
15905357|NCT03608059|Drug|ATG/PTCy|low dose Antithymocyte Globulin plus low dose post-transplant cyclophosphamide as graft-versus-host disease prophylaxis in haploidentical peripheral blood stem cell transplantation
15905358|NCT03608059|Drug|standard ATG|in vivo T cell depletion (TCD) with anti-thymocyte globulin (ATG) as graft-versus-host disease prophylaxis in haploidentical peripheral blood stem cell transplantation
15905359|NCT03608059|Drug|standard PTCy|post-transplant cyclophosphamide (PTCy) as graft-versus-host disease prophylaxis in haploidentical peripheral blood stem cell
15905360|NCT03608046|Drug|Avelumab|Avelumab will be administered at a fixed dose of 10 mg/kg once every 2- week
15905361|NCT03608046|Drug|Cetuximab Injection|Cetuximab will be administered at 400 mg/m2 loading dose week 1, 250 mg/m2 from week 2 followed by 500 mg/m2 from week 3 and irinotecan administered every 2 weeks (180 mg/m2).
15905362|NCT03608046|Drug|Irinotecan|Irinotecan will be administered every 2 weeks (180 mg/m2)
15905363|NCT03608033|Biological|OMS721|Biological: OMS721
15905364|NCT03608033|Other|Vehicle (D5W or saline)|5% Dextrose in water or normal saline solution
15905365|NCT03608020|Drug|BMX-001|Manganese butoxyethyl pyridyl porphyrin
15905366|NCT03608020|Radiation|Whole Brain Radiation Therapy|Whole Brain Radiation Therapy per standard of care.
15905367|NCT03608007|Drug|X-396 Capsule|225 mg once daily
15905370|NCT03607968|Procedure|The novel anterior TVM surgeries|A novel transvaginal mesh (TVM) surgery fro women with pelvic organ prolapse (POP) had been reported. Chang TC, Hsiao SM, Chen CH, Wu WY, Lin HH. Clinical outcomes and urodynamic effects of tailored transvaginal mesh surgery for pelvic organ prolapse. Biomed Res Int http;//dx.doi.org/10.1155/2015/191258.
15905371|NCT03607955|Drug|AVB-S6-500|AVB-S6-500 is supplied by Aravive Biologics
15905372|NCT03607955|Drug|Paclitaxel|Commercially available
15905373|NCT03607955|Drug|Carboplatin|Commercially available
15905374|NCT03607955|Procedure|Tissue from Diagnostic Laparoscopy|-For patients scheduled to undergo a diagnostic laparoscopy for tissue diagnosis prior to neoadjuvant chemotherapy, a tissue biopsy section from the ovary or an intra-abdominal implant will be performed
15905375|NCT03607955|Procedure|Tissue from Core biopsy|-Standard of care procedure but research specimens will be collected
15905376|NCT03607955|Procedure|Interval Debulking|"Standard of Care
~Research tissue samples will be collected"
15905377|NCT03607955|Procedure|Peripheral blood|-Before initiation of neoadjuvant chemotherapy and at the time of interval debulking surgery either pre-operatively, intraoperatively, or post-operatively.
15905378|NCT03607955|Procedure|Ascites collection|-A total of 25-100ml of ascites will be collected prior to chemotherapy treatment, if available.
15905379|NCT03607942|Dietary Supplement|HMO supplement|HMO supplement will be given three times a day, not mixed with any feeding.
15905380|NCT03607942|Dietary Supplement|Placebo comparator|Control product without any HMOs. The Placebo Comparator will be matched to the experimental product in energy content.
15905381|NCT03607929|Procedure|optimal|Physiological Saline Solution
15905382|NCT03607929|Procedure|variability|Other solutions
15905383|NCT03607916|Drug|Hyperbaric prilocaine 2%|Varying dose according to sensitive response of previous subjects. All study doses of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine
15905384|NCT03607916|Drug|Hyperbaric prilocaine 2%|The dose of 60 mg of Hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine
15905385|NCT03607916|Drug|Morphine|100µg morphine
15905386|NCT03607903|Biological|Adalimumab ID|Adalimumab intradermal using MicronJet600 microneedle from NanoPass
15905387|NCT03607903|Biological|Adalimumab SC|Adalimumab subcutaneous using regular needle
15905388|NCT03607903|Other|Saline ID|Saline intradermal using MicronJet600 microneedle from NanoPass
15905389|NCT03607903|Other|Saline SC|Saline subcutaneous using regular needle
15905390|NCT03607890|Drug|Nivolumab|Patients will receive treatment every 28 days for up to 2 years. Nivolumab will be administered IV on day 1 (28 day cycle).
15905391|NCT03607890|Drug|Relatlimab|Patients will receive treatment every 28 days up to 2 years. Relatlimab will be administered IV on day 1 (28 day cycle).
15905392|NCT03607890|Drug|Nivolumab|Patients will receive treatment every 28 days for up to 2 years. Nivolumab will be administered IV on day 1 (28 day cycle).
15905393|NCT03607890|Drug|Relatlimab|Patients will receive treatment every 28 days up to 2 years. Relatlimab will be administered IV on day 1 (28 day cycle).
15905394|NCT03607877|Behavioral|Pedometer walking training and positive education|"Intervention: (1)Positive education: Six psychosocial sessions were designed to enhance elders' positive emotion, motivation and self-efficacy to walk.
~(2) Pedometer walking training: walk at least 30 minutes per day and at least three times per week with family support and exercise companions."
15905395|NCT03607877|Behavioral|Pedometer walking with training|Intervention:walk at least 30 minutes per day and at least three times per week with family support and exercise companions.
15905396|NCT03607877|Behavioral|pedometer walking|Intervention: pedometer walking at least 30 minutes per day and at least three times per week
15905397|NCT03607864|Device|coral bone graft and xenograft|"ligible patients will be randomized in equal proportions between control group(immediate implant placement with grafting with xenograft) and study group (immediate implant placement with grafting with coral bone) Patients of both groups will be subjected to standard panoramic radiographs, cone beam ct .
~Crestal bone level will measured by cone beam ct. Local anesthesia will be given to the patient. Only sulcular incision line with reflection is used A peritome will be used for a traumatic extraction of remaining roots. The extraction socket will be evaluated for absence of any fenestration or granulation tissues implant will be inserted in extraction socket bodily palatal with grafting with coral bone and xenograft The flap will then be copiously irrigated with saline in preparation for closure.
~The flap will then be closed using interrupted 5/0 prolene sutures."
15905398|NCT03607851|Drug|Lacosamide - conventional titration|Administration of lacosamide by the following schedule, Initial: 50 mg PO BID Increase dose at weekly intervals by 50 mg PO BID; up to 200 mg BID
15905399|NCT03607851|Drug|Lacosamide - rapid titration 1|Administration of lacosamide by the following schedule, Initial: 100 mg PO BID Increase dose to 200 mg BID after one week
15905400|NCT03607851|Drug|Lacosamide - rapid titration 2|Administration of lacosamide by the following schedule, Initial: 50 mg PO BID Increase dose every two days by 50 mg PO BID; up to 200 mg BID
15905401|NCT03607838|Drug|SI-6603|SI-6603 will be injected into an intervertebral disc.
15905402|NCT03607838|Drug|Sham injection|The injection will be performed without needle placement into an intervertebral disc.
15905403|NCT03607825|Device|Neurapheresis System|CSF filtration system and lumbar catheter
15905404|NCT03607799|Behavioral|Dietary Intervention|Individualized diet advice will be developed for each participant by a dietitian familiar with South Asian foods.
15905405|NCT03607799|Behavioral|Control|"Control group participants will be provided with paper copies and website links to The Sensible Guide to a Healthy Pregnancy, which provides advice on healthy eating, physical activity, and other lifestyle factors during pregnancy."
15905406|NCT03607786|Procedure|Retrograde Inferior Vena Caval Perfusion|Retrograde Inferior Vena Caval Perfusion is achieved by tethering the inferior vena cava with a band around the cannula and by clamping the distal end of the inferior vena cava drainage tube, which allowed a pump to drive oxygenated blood into the inferior vena cava. Pump pressure is maintained at 20-30 mmHg, and blood flow is maintained at 8-12 mL/min/kg. The aim of RIVP is to maintain the lower body perfusion during circulation arrest, and reduce the ischemia-associated vital organ injury.
15905407|NCT03607786|Procedure|Select antegrade cerebral perfusion|Antegrade cerebral perfusion is achieved using a 12 F cannula inserted into the brachiocephalic artery or right axillary artery. The antegrade perfusion flow rate is maintained at 6-12 mL/min/kg
15905408|NCT03607773|Behavioral|Mindfulness Behavioural Intervention (MBI) group|While every MBI session is different, in general they will help you develop skills in focused attention, and emotional and behavioural regulation in a group environment made up of other people with MS who may share common experiences with you. MBI sessions are group-based which means you will be attending the sessions with other people who are also in this study and facilitated by trained personnel .
15905409|NCT03607760|Device|ECMO|the patients with severe respiratory failure were supported by ECMO
15905410|NCT03607760|Device|conventional mechanical ventilation|the patients with severe respiratory failure were supported by conventional mechanical ventilation
15905411|NCT03607734|Drug|Amoxicillin|"A graded oral challenge test, using amoxicillin in syrup form, will be administered as follows:
~50mg amoxicillin (10% total dose)
~250mg amoxicillin (50% total dose)
~200mg amoxicillin (remainder needed to complete a 500mg full dose) A 20 minute interval will separate each dose given, and participants will be observed throughout the test. They will be required to stay for one hour after the final dose has been administered. Fully trained staff and all equipment for emergency resuscitation will be immediately available."
15905412|NCT03607721|Device|Body Motion Evaluation DARI|Dynamic Athletic Research Institute (DARI) Software to evaluate motion tridimensionally with a camera system and without the use of body sensors.
15905413|NCT03607708|Other|Mindfulness-Based Cognitive Therapy (MBCT)|The MBCT intervention will consist of group conducted meditative practices, lasting 2 hours per week for 8 weeks. Patients will be invited to try various techniques during sessions (brief silent meditations, guided meditations, body scans, gentle arm movement exercises).
15905414|NCT03607708|Other|Health Enhancement Program (HEP)|Health Enhancement Program (HEP) : Has been previously designed and used for the purpose of being a manualized active control in meditation-based intervention trials, controlling for several non-specific factors found in a mindfulness meditation group. Participants will learn about health promotion, healthy diet, music, exercise as well as implementing positive health-enhancing life changes both in-session and during at-home practice with the support of a group facilitator, but do not learn mindfulness techniques.
15905416|NCT03607682|Procedure|Tumor Treating Fields (TTF) Therapy|Undergo TTF therapy
15905417|NCT03607682|Device|NovoTTF-200A Device|Undergo TTF therapy
15905418|NCT03607682|Other|Quality-of-Life Assessment|Ancillary studies
15905419|NCT03607669|Other|Mangafodipir trisodium|Manganese-based MRI contrast agent
15905420|NCT03607656|Drug|Oxaliplatin|Oxaliplatin powder injection
15905421|NCT03607656|Drug|Capecitabine|Capecitabine tablet
15905422|NCT03607656|Other|TCM|TCM decoction orally taken twice a day for at least 3 months
15905423|NCT03607656|Drug|S-1|S-1 capsule
15905424|NCT03607656|Drug|Docetaxel|Docetaxel injection
15905425|NCT03607656|Drug|5-FU|5-FU injection
15905426|NCT03607643|Drug|Cannabidiol|"Sublingual dose of 1 mL (0.910 g) of BRCX014 in the morning, prior to the first meal of the day
~Sublingual dose of 1 mL (0.910 g) of BRCX014 in the afternoon, prior to the evening meal"
15905427|NCT03607643|Drug|Bortezomib|Standard of care (SOC) chemotherapy for multiple myeloma will include a bortezomib-based regimen given at 1.3 mg/m2 on days 1, 4, 8 & 11 schedule to be repeated every 21 days.
15905428|NCT03607643|Drug|Leucovorin|Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.
15905429|NCT03607643|Drug|5-FU|Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.
15905430|NCT03607643|Drug|Oxaliplatin|Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.
15905431|NCT03607643|Drug|Bevacizumab|Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.
15905432|NCT03607643|Drug|Irinotecan|Standard of care chemotherapy for Stage IV colon or rectal cancer, will include leucovorin 350 mg/m2 IV over 2 hours Day 1, 5-FU 400 mg/m2 IV bolus followed 2400 mg/m2 IV over 46 hours, oxaliplatin 100 mg/m2 IV Day 1, bevacizumab 5 mg/kg IV day1. Irinotecan can be substituted for oxaliplatin.
15905433|NCT03607643|Drug|Gemcitabine|Stage IV pancreatic cancer will include a gemcitabine-based regiment at 1000 mg/m2 day 1, 7, 15 of a 21-day cycle.
15905434|NCT03607643|Drug|Temozolomide|Standard of care chemotherapy for patients with glioblastoma multiforme includes concurrent radiation therapy (2 Gy per day for a total of 60 Gy) and temozolomide (75 mg per square meter of body-surface area per day, 7 days per week from the first to the last day of radiotherapy), followed by six cycles of adjuvant temozolomide (150 to 200 mg per square meter for 5 days during each 28-day cycle).
15905435|NCT03607630|Other|Imagery Rescripting|psychological therapy
15905436|NCT03607617|Other|SDH Tool|The SDH tool is embedded in the EMR to collect and act on individualized social determinants of health data.
15905437|NCT03607604|Genetic|Next generation sequencing (NGS)|Patients will be tested for known MODY genes with specific focus on HNF1A, GCK and HNF4A genes. Furthermore, gene panel testing may be performed for any known diabetes genes.If the results are negative, WES/WGS will be performed in patients suspected of having MODY for identification of novel MODY mutations.
15905438|NCT03607591|Other|rTMS|rTMS is a non-invasive and safe brain stimulation technique, that uses a magnetic pulse, administrated through a coil, set on the DLPFC
15905439|NCT03607578|Behavioral|Other: Control Group - Minimal Intervention|Basic Campaign Folder
15905440|NCT03607578|Behavioral|Experimental: Protection Routine 1|New folder, sun advice of Danish Sun Safety Campaign, rationale, prioritization, overview of sun prevention. Activity planner with outdoor activities like bathing, sports and excursions before and after noon (UVI maximum) and indoor activities; shopping, lunch, relaxation and transportation in middle of day and possibility to plan vacation to minimize risk. Instructions for download of UV-App includes use of alert, and information about the features of the app; how to be informed of current UV risk before and during vacation. Link for download of the app is sent by text-message and e-mail. Skintype guide is included in the app and as an individual entity. It includes scoring questions about tan and burn reaction in the sun, a color scale, eye and hair color and freckles. Participants get a description of their skin type and examples of time their particular skin type will resist the sun before erythema occurs at particular UV-levels and functions as an eye-opener.
15905441|NCT03607578|Behavioral|Experimental: Protection Routine 2|The sunscreen application instruction is based on a recently developed thorough application instructions for use of sunscreen to counter the problems and deficits of current sunscreen use. It describes every part of the body, the needed volume for that part and application patterns. The package will also include a hat specifically designed for protection and comfort and the availability of a hat will function to increase the use of hat. The hat is simple bucket hat version with a brim, cheap, in light fabric and foldable for easy packing.
15905442|NCT03607552|Device|Non-contrast DWI|Diffusion-weighted imaging (DWI) is a non-contrast MRI technique that typically can be acquired in under 5 minutes. DWI reflects the microscopic cellular environment and can demonstrate differences between normal and malignant breast tissue without the aid of intravenous gadolinium.
15905443|NCT03607552|Device|Non-contrast MRI|Non-contrast MRI scans will include DWI along with anatomical T1-weighted and T2-weighted sequences.
15905444|NCT03607539|Drug|Sintilimab|10 mL:100 mg，200mg，Q3W (qualer 3 weeks), day1, I.V.
15905445|NCT03607539|Drug|Pemetrexed|500mg/m^2; Q3W (qualer 3 weeks), day1, I.V.
15905446|NCT03607539|Drug|Platinum|Q3W (qualer 3 weeks), day1, I.V.; first 4 cycles.
15905447|NCT03607539|Drug|Placebos|10 mL:100 mg，200mg，Q3W (qualer 3 weeks), day1, I.V.
15905448|NCT03607526|Other|Barriers|NGT sessions identifying barriers to vegetable intake.
15905449|NCT03607526|Other|Facilitators|NGT sessions identifying facilitators to vegetable intake.
15905450|NCT03607513|Drug|JNJ-64264681|For all cohorts except the solid dose formulation cohort, JNJ-64264681 wlll be administered as oral solution. For the solid dose formulation cohort, JNJ-64264681 will be provided as capsules for oral administration.
15905451|NCT03607513|Drug|Placebo|Matching placebo to JNJ-64264681 will be administered as oral solution.
15905452|NCT03607500|Behavioral|caloric intake reduction|The caloric intake reduction arm will been seen by the kidney disease dietitian at all clinical visits for the first 3 months (weekly for month 1, every other week for months 2 and 3).
15905453|NCT03607487|Drug|INCB054707|INCB054707 tablet administered orally once daily at the protocol-defined dose.
15905454|NCT03607487|Drug|Placebo|Placebo tablet administered orally once daily.
15905455|NCT03607474|Other|Questionnaires of life quality for patients|"the WhoQoL
~a specific scale of Cushing's syndrome
~The Beck II scale
~HAD scale
~Rosenberg questionnaire
~Stunkard, Sorensen and Schlusinger (1983) figurines
~Brief Cope scale"
15905456|NCT03607474|Other|Questionnaires of life quality for caregivers|"the WhoQoL
~The Beck II scale
~HAD scale"
15905457|NCT03607461|Device|Smartphone App|Smartphone App Users will engage with the app at least daily and follow along with the prescriptive exercises as instructed.
15905458|NCT03607461|Combination Product|Control Group|Home Health users will have received traditional home health physical therapy and skilled nursing services.
15905459|NCT03607448|Device|Freestyle Libre Flash Glucose Monitoring System|Subjects will wear the Abbott Sensor based FreeStyle Libre Flash Glucose Monitoring System and will receive no treatment except for safety purposes
15905460|NCT03607435|Device|Spectroscopy for Analyte Quantification|Diabetic hospital staff participants subjected to the KBS-1 device (Test Article #01) will have a finger on their left hand pricked with a lancet and their blood glucose level read by a POC glucose monitor (Control Article #02). Next, they will have their interstitial fluid glucose level spectroscopically scanned from the palm of their left hand using the KBS-1 device, and blood (approximately 40µl), collected from their finger prick site, will be spectroscopically scanned using the RBA-1 device (Test Article #02). Hospital patients subjected to the RBA-1 device, who must already be prescribed a hospital lab blood test by their physician, will have approximately 40µl of their blood, collected from the venipuncture site, spectroscopically scanned using the RBA-1 device (Test Article #02).
15905461|NCT03607422|Drug|Upadacitinib|Oral; Tablet
15905462|NCT03607422|Drug|Placebo for Upadacitinib|Oral; Tablet
15905463|NCT03607383|Drug|Red Rice Yeast Extract|adults requiring moderate intensity treatment will be provided red rice yeast extracts or statins, depending on the randomization; followed for compliance and adverse effects check, and reevaluated in a final visit with blood test after 8 weeks
15905464|NCT03607383|Drug|Statin|Statin choice is done at the discretion of the treating physician for a moderate intensity treatment equivalent according the American College of Cardiology/American Heart Association (ACC/AHA) guidelines definitions, for 8 weeks
15905465|NCT03607370|Procedure|Surgery after 12 weeks of delay after chemoradiotherapy.|Surgery consists oncologic resection of the rectal cancer with total excision of the mesorectum after 12 weeks of delay after the end of chemoradiotherapy.
15905466|NCT03607357|Device|High Flow Nasal Oxygen|The initial flow speed is set at 30L/min and increases at 5L/min in titrated type until the patient feels uncomfortable. The temperature is set at 37℃. The fraction of inspiration O2 is set in accordance with specific condition of patient to insure oxygen saturation more than 95%.
15905467|NCT03607357|Device|Non-invasive Ventilation|The values of initial pressure are set at a lower level (inspiratory pressure: 6-8cmH2O, expiratory pressure: 4cmH2O) and adjusted to a suitable level in 10-20min. The fraction of inspiration O2 is set in accordance with specific condition of patient to insure oxygen saturation more than 95%.
15905468|NCT03607344|Procedure|Cohort|Patients undergoing ambulatory laparoscopic sacrocolpopexy
15905469|NCT03607331|Device|Auricular vagus nerve stimulation|Auricular vagus nerve stimulation is a typical representative of TCM modernization.
15905470|NCT03607331|Drug|Citalopram|Citalopram is an antidepressant drug of the selective serotonin reuptake inhibitor (SSRI) class.It has U.S. Food and Drug Administration approval to treat major depression.
15905471|NCT03607318|Behavioral|iASIST|Integrated Alcohol and Suicide Intervention for Suicidal Teens
15905472|NCT03607305|Procedure|BP limb 70cm|Performance of RYGB with a BP limb of 70cm
15905473|NCT03607305|Procedure|BP limb 120cm|Performance of RYGB with a BP limb of 120cm
15905474|NCT03607292|Procedure|Anterior sciatic nerve block|A straight line along the femoral catheter was drawn between the anterior superior iliac spine and the finger palpating the pubic bone, the index finger was placed over the femoral artery pulse, a line was drawn perpendicular to the femoral fold. Over the pulse of the femoral artery, a point 4-5 cm lateral. The sciatic nerve was imaged by USG along the needle route and the needle was advanced to the nerve.
15905575|NCT03606486|Other|Laboratory Biomarker Analysis|Correlative studies
15905576|NCT03606486|Device|Lavage|Undergo uterine lavage
15905475|NCT03607292|Procedure|Posterior sciatic nerve block|Patient was positioned laterally, with the limb to be blocked uppermost. The lower leg was straight extended and the upper extremity was bent 90° from the knee and was directed forward on the lower straight extended extremity. The patient's greater trochanter and posterior superior iliac spine were palpated and joined with a line, and a line was drawn 4 cm above the first line perpendicular to the caudal line. The USG probe was placed between the greater trochanter and the coccyx at the entry point of the needle and the needle was advanced by imaging the nerve.
15905476|NCT03607279|Procedure|NGAL|
15905477|NCT03607253|Other|repetitive heel rise activity|Participants will perform a maximal number of single-legged heel rises on a 10 degrees incline board. Participants will be permitted to apply for fingertip support at shoulder height on a wall in front of them. The test will be terminated when participants could no longer lift their heels from the incline board. The number of correct heel rises will be counted for each leg and will be used as Heel Rise Test score.
15905478|NCT03607240|Procedure|lung ultrasound-guided alveolar recruitment|Alveolar recruitment maneuver will be performed under lung ultrasound-guidance. Positive pressure will be not exceed 40cmH2O and duration of positive pressure inflation will not exceed 10 seconds.
15905479|NCT03607240|Procedure|conventional alveolar recruitment|Alveolar recruitment will be provided with positive pressure of 30cmH2O for 10 seconds
15905480|NCT03607227|Drug|Levobupivacaine|Active substance. Levobupivacaine 3.75 mg/ml 15 ml is given as a bolus injection at start of surgery, followed by ropivacaine 2 mg/ml continous infusion 5-8 ml/h from the end of surgery until end of intervention at the fourth to seventh postoperative day.
15905481|NCT03607227|Drug|Saline Solution|Placebo. Saline solution (NaCl 0.9%) is given in equivalent intervals and doses as the active substances.
15905482|NCT03607214|Other|Placebo|"Placebo nasal spray
~Film Sequence"
15905483|NCT03607201|Other|No intervention|Routine care
15905484|NCT03607188|Drug|Alkotinib|Alkotinib 200mg QD、 Alkotinib 300mg QD、 Alkotinib 400mg QD、 Alkotinib 500mg QD、 Alkotinib 600mg QD
15905485|NCT03607175|Drug|Triamcinolone-impregnated CMC foam|same information as included in the arm/group descriptions
15905486|NCT03607175|Device|Propel Stent|same information as included in the arm/group descriptions
15905487|NCT03607162|Diagnostic Test|DIAFEVER algorithm|PCT rapid test-based predictive algorithm
15905488|NCT03607149|Drug|Pemetrexed|"standard arm : calculating the dose of pemetrexed according to body surface area
~experimental arm: calculation of the dose of pemetrexed as a function of creatinine clearance (CrCLCG)"
15905489|NCT03607136|Other|exercise training|Aerobic exercises, strengthening exercises, flexibility training for 60min, twice a week for 12 weeks
15905490|NCT03607123|Other|programing of pacemaker|Different programing parameters will be set in different group/stage
15905491|NCT03607123|Procedure|AF ablation|AF ablation can only be performed in Step 3
15905492|NCT03607123|Drug|Anti arryhthmic drugs|Anti arryhthmic drugs can be prescribed in Step 2, Step3 and SAFE PAF-SND
15905493|NCT03607110|Drug|Ketamine|sedation drugs
15905494|NCT03607110|Drug|fentanyl|sedation drugs
15905495|NCT03607110|Device|patient control analgesia|patient control analgesia
15905496|NCT03607097|Procedure|Secondary prevention program for drug related problems|The interventions consists of three stages: 1) actions aimed at improving the chronic prescription of the patient, 2) actions aimed at improving the therapeutic adherence and 3) actions aimed at improving the assistance healthcare levels coordination
15905497|NCT03607084|Behavioral|School Health Worker Program|The intervention trains selected teachers to deliver health lessons to students, perform basic first aid, recognize common illnesses, refer student to skilled medical attention when needed. The intervention provides schools with basic medical supplies including pain relief medication, thermometers, bandages, antiseptics, and oral rehydration solution. Vitamin A supplementation and presumptive deworming medication are administered to students during biannual health screenings.
15905498|NCT03607071|Drug|Prednisolone and taper|Prednisolone 30 mg/d and taper 5-10 mg per 2 weeks until off at week 24.
15905499|NCT03607058|Other|Kinect + Exercise Training|Kinect + Exercise Training : Patients will play Xbox Kinect games for 40 minutes and take the treatment for 20 minutes, 3 days in a week for 8 weeks. After 10 weeks washout period, patients will take the treatment 1-hour, 3 days in a week for 8 weeks.
15905500|NCT03607058|Other|Exercise Training|Exercise Training: Patients will take the treatment 1-hour, 3 days in a week for 8 weeks. After 10 weeks washout period, patients will play Xbox Kinect games for 40 minutes and take the treatment for 20 minutes, 3 days in a week for 8 weeks.
15905501|NCT03607045|Device|headless screw|headless screw group
15905502|NCT03607032|Device|Respin Pad|RespinPad slid into the back of the patient sitting at 45° in the armchair or bed.
15905503|NCT03607032|Other|usual treatment|medical aerosol session followed by aspiration or not, as required
15905504|NCT03607006|Procedure|Patient specific PEEK sheets|Computer aided sheet design
15905505|NCT03607006|Procedure|Autogenous bone shell|autogenous retromolar/chin bone graft
15905506|NCT03606993|Other|Lucky Iron Fish (TM) - An iron ingot that is a Cooking supplement|For Mother-infant dyads enrolled into the LIF arm, mother receives one ~ 200g iron ingot, instructions on use: add 2-3 drops of lemon juice to one-liter of water, place iron ingot in water, bring to boil for 10 minutes, remove iron fish from water and then use that water for cooking or drinking.
15905507|NCT03606980|Drug|Dexamethasone Sodium Phosphate|Dexamethasone sodium phosphate administered via iontophoresis
15905508|NCT03606980|Procedure|Iontophoresis|Iontophoresis on affected knee
15905509|NCT03606980|Procedure|Physical Therapy|Physical therapy of affected knee
15905510|NCT03606967|Drug|Carboplatin|Given IV
15905511|NCT03606967|Biological|Durvalumab|Given IV
15905512|NCT03606967|Drug|Gemcitabine Hydrochloride|Given IV
15905513|NCT03606967|Drug|Nab-paclitaxel|Given IV
15905514|NCT03606967|Biological|Personalized Synthetic Long Peptide Vaccine|Given SC
15905515|NCT03606967|Drug|Poly ICLC|Given SC
15905516|NCT03606967|Biological|Tremelimumab|Given IV
15905517|NCT03606954|Combination Product|Combination topical corticosteroid|Comparison of a vasoconstriction index between the 2 study arms
15905577|NCT03606486|Other|Pap Smear|Undergo pap smear
15905578|NCT03606473|Drug|d-amphetamine|is used to stimulate dopamine release in the brain
15905518|NCT03606941|Device|electroacupuncture treatment|"Participants in the electroacupuncture group received acupuncture (0.30mm×70mm) at bilaterally Shenmen (HT7) acupoints (0.3-0.5 inch), Neiguan (PC6) acupoints (0.5-1 inch), Baihui (DU20) acupoint (0.5-0.8 inch) and Yintang (EX-HN3) acupoint (0.3-0.5 inch) 30 minutes before anesthesia induction. After Deqi, electroacupuncture stimulation apparatus (HANS G6805-2, Huayi Co, Shanghai, China) is connected with the density wave (2/100 Hz), width 0.25 ms, intensity of 1 ~ 30 mA (gradually increase to the patient's maximum tolerance) and maintained the end of operation."
15905519|NCT03606941|Device|sham electroacupuncture treatment|"Participants in the sham electroacupuncture group received shallow needling (0.30mm×25mm) at bilateral sham HT7, PC6, DU20 and EX-HN3 (nonacupoints located 1 inch beside acupoints, about 20mm). Specifically, the depth of needle insertion into nonacupoints is 3-5mm and avoided manual stimulation and no Deqi without actual current output, and retained the needle until the end of surgery."
15905520|NCT03606928|Drug|docetaxel, oxaliplatin, 5-FU, leucovorin|This is a single-arm study with all patients receiving mFLOT chemotherapy.
15905521|NCT03606915|Behavioral|pain evaluation|collect CSF during spinal anesthesia
15905522|NCT03606902|Procedure|Group f : Epidural catheter insertion|Infiltrate the skin with local anesthetic lidocaine approximately 1 cm lateral to the inferior aspect of the targeted spinous process , epidural needle tip is midline at the junction of the lamina and spinous process . The needle is withdrawn and advanced with the same medial angle but in small increments cephalad to the same depth. Either bone or ligamentum flavum is contacted. If bone is contacted, the needle is redirected cephalad and advanced. If bone is no longer contacted and the depth exceeds the depth previously noted, the epidural needle stilette is removed. loss-of-resistance syringe is attached to the needle Once attained, stabilize the epidural needle and thread the catheter. Secure the catheter using a sterile locking device and adherent dressings.
15905523|NCT03606902|Drug|Group F: Continous epidural infusion of bupivacaine plus fentanyl|Epidural injection of bolus of 15 ml total Volume of 0.0625%bupivacaine with 1 µg /Kg Fentanyl initial bolus, then from the 1st hour continuous epidural infusion of 0.0625% bupivacaine with µ/Kg/h Fentanyl fixed for the next 5 hour during operation and in the recovery room after recovery of general anesthesia then stop epidural infusion. (Total infusion time 6 hours=maximum hours needed for nephrectomy surgery)
15905524|NCT03606902|Drug|Group LF :Continous epidural infusion of decreasing doses of fentanyl plus pubivacaine|Epidural injection of bolus of 15 ml total Volume of 0.0625%bupivacaine with 1 µg/Kg Fentanyl initial bolus, then continuous IV infusion of 0.0625%bupivacaine with 1 µg/Kg/h Fentanyl for the 1st hour then continuous epidural infusion of 0.0625%bupivacaine with 0.5 µg/Kg/h Fentanyl during the 2nd hour, then 0.0625%bupivacaine with 0.25 µ g/Kg/h Fentanyl for the 3rd hour then continue the same infusion volume and dose (0.0625%bupivacaine with 0.25Mg/Kg/h Fentanyl) for the next 3 hours during operation and in the recovery room after recovery of general anesthesia then stop epidural infusion. (Total infusion time 6 hours=maximum hours needed for nephrectomy surgery)
15905525|NCT03606902|Procedure|Group L f : Epidural catheter insertion|Infiltrate the skin with local anesthetic lidocaine approximately 1 cm lateral to the inferior aspect of the targeted spinous process , epidural needle tip is midline at the junction of the lamina and spinous process . The needle is withdrawn and advanced with the same medial angle but in small increments cephalad to the same depth. Either bone or ligamentum flavum is contacted. If bone is contacted, the needle is redirected cephalad and advanced. If bone is no longer contacted and the depth exceeds the depth previously noted, the epidural needle stilette is removed. loss-of-resistance syringe is attached to the needle Once attained, stabilize the epidural needle and thread the catheter. Secure the catheter using a sterile locking device and adherent dressings.
15905526|NCT03606889|Diagnostic Test|Quadratus Lumborum block|0.2 ml/kg bupivicaine 0.125% injected bilateraly at the posterior border of the quadratus Lumborum muscle
15905527|NCT03606889|Diagnostic Test|Tranversus Abdominis plane block|0.2 ml/kg bupivicaine 0.125% injected bilateraly between internal oblique and transversus abdominis muscles.
15905528|NCT03606889|Drug|Bupivacaine|0.2 ml/kg bupivicaine
15905529|NCT03606876|Drug|BAT1806 injection|Each subject will receive single intravenous drip of 4 mg/kg BAT1806 Injection or Actemra® (EU-licensed and US-licensed).
15905530|NCT03606863|Drug|Perioperative peripheral parenteral nutrition|
15905531|NCT03606850|Device|Measurements of markers of cortical excitability by TMS|"In the arm experimental treatment by citalopram, measurements of markers of cortical excitability by Transcranial Magnetic Stimulation will be applied. These measurements were: the cortical silent period CSP, the evoked potential MEP, the intra-cortical inhibition ICI and the intra-cortical facilitation ICF). Electromagnetic coil is placed upon the vertex, according to the International 10-20 EEG system. Gathering of the peripheral signal by a surface EMG electrode (non invasive device) placed regarding one of the first dorsal interosseous muscle."
15905532|NCT03606837|Drug|68Ga-PSMA-617 PET/CT|PET/CT Imaging with 68Ga-PSMA-617 injection
15905533|NCT03606837|Drug|68Ga-RM2 PET/CT|PET/CT Imaging with 68Ga-RM2 injection
15905534|NCT03606824|Drug|Pitavastatin and placebo|The initial dosage of pitavastatin is 2mg, and it will be regulated according to the level of LDL-C and the upper limit is 4mg.Since the investigators are blind to the arms,the fake regulation of placebo dosage will be same as the Pitavastatin and levothyroxine group.
15905535|NCT03606824|Drug|Pitavastatin and levothyroxine|The initial dosage of pitavastatin is 2mg and the initial dosage of levothyroxine is 12.5ug. The dosage of levothyroxine will be regulated according to thyroid function test every 2-3 weeks. The regulation of pitavastatin dosage is same as the monotherapy group.
15905536|NCT03606811|Procedure|fluroscopic guided block|SHPB will be done Fluoroscopic-guided (the posterior oblique trajectory technique.
15905537|NCT03606811|Procedure|double modality (ultrasound and fluroscopic) guided block|SHPB will be done using our described new technique of performing the modified Mishra technique by injecting 3-5 ml of contrast media (lohexol=omnipaque) after getting the target position. Then C-arm pictures will be checked (both P-A & dead lateral)
15905538|NCT03606798|Other|3 Home visits made by a psychologist|Patient and caregiver interviews with a psychologist at home
15905539|NCT03606785|Drug|Tranexamic Acid Injection|The TA group will receive an intravenous bolus of (10 mg/kg) in 100 ml of normal saline over 20 minutes after induction of anesthesia and before surgical incision
15905540|NCT03606785|Drug|placebo injection|patients will receive a placebo of 100 mL 0.9% normal saline
15905541|NCT03606772|Other|Questionanniare|Filling printed questionnaire + Pelvic examination
15905542|NCT03606759|Procedure|Weekly assessment|"Weekly assessment during 3 months :
~Severity of addiction (Addiction Severity Index, ASI) Mini International Neuropsychiatric Interview, MINI Craving intensity (BILAN-7 jours) Individual cues of each participant (QSA) Substance use and gambling (BILAN-7 jours)"
15905543|NCT03606759|Procedure|Weekly assessment ajusted|"Weekly assessment during 3 months :
~Severity of addiction (Addiction Severity Index, ASI) Mini International Neuropsychiatric Interview, MINI Craving intensity (BILAN-7 jours) Individual cues of each participant (QSA) Substance use and gambling (BILAN-7 jours) Individually Adjusted Therapy scale (ATI)"
15905544|NCT03606746|Biological|MDR-103|MDR-103 Enriched CD34+ hematopoietic stem cells and defined dose of CD3+ T-cells
15905545|NCT03606733|Procedure|Custom suorachoroidal needle|Custom made Supra Choroidal Space needle
15905546|NCT03606720|Other|low level laser therapy|low level laser therapy (LLLT) is a modality that has been used by the medical profession for decades to treat acute and chronic pain conditions ranging from tendonitis and bursitis, to back pain and pelvic girdle pain.
15905547|NCT03606720|Other|pelvic stabilization exercises|special program of pelvic stabilization exercises depending on exercising of transverse abdominal in addition to co activation of lumbar multifidus muscles at the lumbosacral area , exercising of oblique abdominal, gluteus maximus, latissimus dorsi muscles , quadratus lumborum, erector spinae, also, hip abductors and adductors. will done by all patients
15905548|NCT03606707|Drug|Steroids|intra-articular steroid injection for atlantoaxial joint
15905549|NCT03606694|Drug|Dihydromyricetin|The intervention wiil be 300 mg, two times per day before break-fast and dinner during 12 weeks.
15905550|NCT03606694|Drug|Metformin|The intervention wiil be 850 mg, two times per day before break-fast and dinner during 12 weeks.
15905551|NCT03606681|Drug|Calcium Hydroxide|After cleaning the caries with partial removal (non-exposed pulp), cavity disinfected with sodium hypochlorite then indirect pulp capping agent was applied to cavity and restoration was finished in the same session.
15905552|NCT03606681|Drug|Mineral Trioxide Aggregate|After cleaning the caries with partial removal (non-exposed pulp), cavity disinfected with sodium hypochlorite then indirect pulp capping agent was applied to cavity and restoration was finished in in the same session.
15905553|NCT03606681|Drug|TheraCal LC|After cleaning the caries with partial removal (non-exposed pulp), cavity disinfected with sodium hypochlorite then indirect pulp capping agent was applied to cavity (2 milimeter layer) and polymerized and restoration was finished in in the same session.
15905554|NCT03606668|Device|Virtual Reality Headset|Study will use the HTC Vive VR system running on a high performance desktop computer
15905555|NCT03606655|Drug|Kava|Kava: 75 mg three times daily (3 capsules)
15905556|NCT03606642|Drug|Dual Antiplatelet (DAPT) Therapy|"DAPT - one of three (3) antiplatelet medications: ticagrelor (Brilinta), clopidogrel (Plavix) or prasugrel (Effient) with Aspirin.
~Aspirin loading dose (LD) = 325 mg. Aspirin maintenance dose (MD) = 81 mg.
~P2Y12 Inhibitor Loading Dose (investigator preference):
~Clopidogrel 600 mg PO x 1 or 75 mg PO daily x 4; Prasugrel 60 mg PO x 1; Ticagrelor 180 mg PO x 1.
~P2Y12 Inhibitor Maintenance Dose (investigator preference):
~Clopidogrel 75 mg PO daily; Prasugrel 10 mg PO daily; Ticagrelor 90 mg PO BID."
15905557|NCT03606642|Device|The Synergy® stent|IVUS guided stent
15905558|NCT03606629|Device|Endoprosthesis implantation|Endoprosthesis implantation by Percutaneous Angioplasty
15905559|NCT03606616|Procedure|no further ALND arm|Patients meeting the Z0011 inclusion criteria to receive no additional ALND
15905560|NCT03606590|Device|NovoTTF-100L(P) device|Patients will be treated continuously with the NovoTTF-100L(P) device. NovoTTF-100L(P) treatment will consist of wearing four electrically insulated electrode arrays on the abdomen. The treatment enables the patient to maintain regular daily routine.
15905561|NCT03606590|Drug|Sorafenib|Sorafenib 400 mg (2 x 200 mg tablets) taken twice daily without food (at least 1 hour before or 2 hours after a meal).
15905562|NCT03606577|Drug|Carfilzomib|Induction 6 cycles 20/36 mg/m² on days 1, 2, 8, 9, 15, 16 (20 mg/m² on D1 and 2 cycle 1 only) Consolidation 4 cycles Carfilzomib 20 or 36 mg/m² on days 1, 2, 8, 9, 15, 16 (20 mg/m² on D1 and 2 first cycle only)
15905563|NCT03606577|Drug|Daratumumab|induction: 6 cycles Daratumumab 8/16mg/kg IV on Days 1, 8, 15, 22 for the first two cycle 2 and on days 1 and 15 for cycles 3 to 6. (8mg/kg on D1 & D2 cycle 1 only) Consolidation: daratumumab 4 cycles 16mg/kg IV Day 1, Day 15 Maintenance Daratumumab 16mg/kg IV once every 8 weeks for 2 years (or until documented disease progression)
15905564|NCT03606577|Drug|Lenalidomide|induction: 6 cycles Lenalidomide 25 mg/day from day 1 to day 21 Consolidation: 4 cycles 15 mg/day from Day 1 to Day 21 (first cycle ) 25 mg/day from Day 1 to Day 21 (in the following cycle) Maintenance therapy 10mg/day, Day 1 to 21, for 2 years (or until documented disease progression)
15905565|NCT03606577|Drug|Dexamethasone|induction 6 cycles 20 mg/day on days 1-2, 8-9, 15-16 and 22-23 Consolidation 4 cycles 40 mg/Day on Days 1, 8, 15 and 22
15905566|NCT03606564|Other|study of fasting time among pediatric patients undergoing day care surgery|parents of children undergoing day care surgery were given a questionnaire to be filled containing questions regarding time of fasting that was instructed and
15905567|NCT03606551|Device|EXD-959 Bracket System|EXD-959 Ceramic Self-ligating Brackets are a new type of esthetic ceramic bracket developed by 3M™ Oral Care Solutions. The brackets have a sliding door and are composed of alumina (aluminum oxide) and small amounts of related oxide compounds (glass powder) to give them a clear appearance. A nickel-titanium wire serves as part of the door mechanism and is attached to the bracket using 3M ESPE™ Scotchbond™ Universal Adhesive. The brackets are classified as a Class II medical device. A FDA 510(k) submission of EXD-959 was submitted the first quarter of 2018.
15905568|NCT03606538|Drug|MDMA|80 mg MDMA
15905569|NCT03606525|Procedure|subarachnoid block|Vertebral column length and abdominal girth will be measured before routine subarachnoid block is given to recruited patients
15905574|NCT03606486|Other|Biospecimen Collection|Undergo collection of tumor sample and blood draw
15905580|NCT03606460|Drug|Ocrelizumab Dose 1|300 mg infusion administered to ocrelizumab-naive participants per approved protocol (over approximately 2.5 hours or longer) as per standard of care followed by a second 300 mg shorter infusion over approximately 1.5 hours.
15905581|NCT03606460|Drug|Ocrelizumab Dose 2 and Dose 3|600 mg infusion of ocrelizumab administered at a shorter rate (i.e. over the course of approximately 2 hours) at Week 24 and at Week 48
15905582|NCT03606447|Drug|Uproleselan|[14C]-Uproleselan
15905583|NCT03606434|Other|Hypoxic exposure|30 minutes of intermittent hypoxia
15905584|NCT03606421|Radiation|SRS and neurocognitive assessments|Patients will be assessed for cerebral blood flow and their neurocognitive function based on a series of neurocognitive tests and questionnaires.
15905585|NCT03606421|Radiation|WBRT and neurocognitive assessments|Patients will be assessed for cerebral blood flow and their neurocognitive function based on a series of neurocognitive tests and questionnaires.
15905586|NCT03606408|Drug|osilodrostat|osilodrostat, in the form of film coated tablets for oral administration, in the following tablet strengths: 1mg, 5mg, 10mg. Each strength has unique tablet size, colour and imprint.
15905587|NCT03606395|Drug|NV-5138|single ascending dose
15905588|NCT03606395|Drug|Placebos|Placebo liquid solution to mimic NV-5138
15905589|NCT03606382|Diagnostic Test|HostDx Fever Test|HostDx Fever test to distinguish between viral and bacterial infections
15905590|NCT03606382|Diagnostic Test|HostDx Sepsis Test|HostDx Fever test to determine the severity of a presented, suspected infection.
15905591|NCT03606369|Drug|Palonosetron|Palonosetron 0.25 mg IV + Dexamethasone 12 mg IV + Fosaprepitant 150 mg IV for early emesis and for delayed emesis Dexamethasone 8 mg orally on days 2, 3 and 4.
15905592|NCT03606369|Drug|Ondansetron|Early emesis: Ondansetron 16 mg IV + Dexamethasone 12 mg IV + Fosaprepitant 150 mg IV. and for delayed emesis: Metoclopramide 10 mg orally every 6 hours + Dexamethasone 8 mg orally every 24 hrs.
15905593|NCT03606356|Drug|Onabotulinum toxin A|Cranial Subcutaneous Injections
15905594|NCT03606343|Behavioral|Teaching Academic Skills to Kids|Group treatment
15905595|NCT03606330|Diagnostic Test|Cardiac imaging tests|"2D transthoracic echocardiography
~128-multislice CT coronary angiography with the evaluation of: epicardial fat volume, plaque burden, total and local calcium score, markers for lesion severity; morphological plaque characteristics; plaque components evaluated via volumetric and planimetric units; markers of plaque vulnerability (necrotic core, low attenuation plaque, spotty calcification, napkin ring sign, positive remodeling).
~Shear stress evaluation via computational fluid dynamics.
~Intracoronary imaging techniques: IVUS and OCT."
15905596|NCT03606330|Diagnostic Test|Venous blood sample collection|Venous blood sample collection during the acute coronary event for evaluation of serum levels of hsCRP, IL-6, matrixmetalloproteases MMP9, Adhesion molecules (VCAM, ICAM), alfa tumour necrosis factor, hs-cTnI, NTproBNP
15905597|NCT03606304|Behavioral|Problem-solving therapy|See previous
15905598|NCT03606291|Radiation|isotoxic hypofractionation|the normal tissue limits are uniform, such as: V20% ≤ 30%, spinal cord 0> 45Gy, etc., and used hypofractionated radiotherapy technology so that each patient received the maximum individualized radiation dose as possible
15905599|NCT03606278|Other|Structured debriefing assisted by video|In the structured debriefing assisted by video, the process was based on the immediate review of the video, stopping and rewinding the recording as required. The debriefing session was conducted in the debriefing room of the simulation laboratory with an assigned time of 15 minutes. Each session was developed in three phases. The first phase, descriptive, in which each participant was encouraged to recount what they had lived and experienced, clarifying how the events unfolded, verifying the appropriate decisions and the errors committed in the scenario and the ways they could have solved them and corrected them. The second phase, analytical, the participant reflected on what occurred in the scenario, commenting on how their feelings were involved in the development of the case. The third phase, application or transference, in which the group was encouraged to draw conclusions from what had occurred, realizing an application of this experience in a real-life.
15905600|NCT03606278|Other|Structured oral debriefing|In the structured oral debriefing, the process was based by the mental search of their memories of what occurred. The debriefing session was conducted in the debriefing room of the simulation laboratory with an assigned time of 15 minutes. Each session was developed in three phases. The first phase, descriptive, in which each participant was encouraged to recount what they had lived and experienced, clarifying how the events unfolded, verifying the appropriate decisions and the errors committed in the scenario and the ways they could have solved them and corrected them. The second phase, analytical, the participant reflected on what occurred in the scenario, commenting on how their feelings were involved in the development of the case. The third phase, application or transference, in which the group was encouraged to draw conclusions from what had occurred, realizing an application of this experience in a real-life.
15905601|NCT03606265|Device|App+Web|Patients will use an app daily twice and physicians will use a website to consult the characteristics of the alarms the app will send them in the presence of an unwanted event
15905602|NCT03606265|Device|Treatment as usual|Patients will be offered the usual treatment for their pain, which is not changed by study participation
15905603|NCT03606252|Other|Blood sampling|6 blood sample, 3 at J0 and 3 at J7 ( 2 tubes EDTA of 7mL, 1 tube Blood RNA of 3 mL)
15905604|NCT03606252|Other|urine sampling|2 urine sample (1 at J0 and 1 at J7)
15905605|NCT03606239|Radiation|isotoxic hypofractionated group|the normal tissue limits are uniform, such as: V20% ≤ 30%, spinal cord 0> 45Gy, etc., and used hypofractionated radiotherapy technology so that each patient received the maximum individualized radiation dose as possible，and the same time use the Platinum-containing drugs: docetaxel + lobaplatin Docetaxel 60 mg/m2, d1; Lobaplatin 30 mg/m2, d1, repeated every 28 days. The first cycle of chemotherapy started on the first day of radiotherapy.Consolidate chemotherapy up to 4 cycles after radiotherapy, as above.
15905606|NCT03606213|Biological|PENNVAX-GP|PENNVAX®-GP is a circular, double stranded, deoxyribonucleic acid consisting of expression plasmids that encode synthetic HIV-1 multiclade consensus Gag, Pol and Env proteins.
15905607|NCT03606213|Biological|INO-6145|INO-6145 is a circular, double stranded, deoxyribonucleic acid consisting of expression plasmids that encode synthetic HIV-1 multiclade consensus Gag and Pol proteins.
15905738|NCT03605082|Other|Placebo|"Pharmaceutical form: solution for infusion
~Route of administration: intravenous use"
15935567|NCT03376503|Drug|Pegfilgrastim|PK,PD and safety assessment
15905608|NCT03606213|Biological|INO-9012|The IL-12 DNA adjuvant (INO-9012) consists of a single plasmid containing a dual promoter system for expression of both the IL-12 p35 and p40 genes necessary for production of the active heterodimeric (p70) IL-12 protein.
15905609|NCT03606213|Device|CELLECTRA® 2000|Electroporation (EP) is a technology in which an electrical field is applied to increase the permeability of cell membranes and thereby enhance the uptake of drugs, vaccines, or other agents into target cells. This technology has been used in the last decade in both therapeutics and vaccinations. EP is currently being used to deliver cancer vaccines and therapeutics as well as in gene therapy. The expression levels are increased by as much as 3 orders of magnitude over plasmid injection alone.
15905610|NCT03606187|Device|Stimgenics SCS Programming Approach|Stimgenics SCS Programming approach Using Intellis(TM) SCS system
15905611|NCT03606187|Device|Standard SCS Programming Approach|Standard SCS Programming approach using Intellis(TM) SCS system
15905612|NCT03606174|Drug|Sitravatinib|Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases
15905613|NCT03606174|Drug|Nivolumab|Nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
15905614|NCT03606174|Drug|Pembrolizumab|Pembrolizumab is a programmed death receptor-1 (PD-1) blocking antibody
15905615|NCT03606174|Drug|Enfortumab vedotin|Enfortumab is a Nectin-4 directed antibody-drug conjugate (ADC) comprised of a monoclonal antibody conjugated to the small molecule microtubule disrupting agent, monomethyl auristatin E (MMAE)
15905616|NCT03606161|Other|Questionnaire Administration|Ancillary studies
15905617|NCT03606161|Procedure|Transcranial Magnetic Stimulation|Undergo nrTMS
15905618|NCT03606148|Diagnostic Test|SurePathTM|In the liquid-phase cytology, a fine-aspirated sample is immediately inserted into a container containing a commercially available preservative solution without a separate slide-smearing procedure and immediately after the fine-needle aspiration.
15905619|NCT03606135|Other|The Pneumonia Group|
15905620|NCT03606135|Other|The Control Group|
15905621|NCT03606122|Drug|PD P 506 A|PD P 506 A is a dermal patch of 4 cm² in size loaded with 2 mg 5-ALA (as 5-ALA HCl) per cm²
15905622|NCT03606109|Drug|Tranexamic Acid (TXA)|Patients will be given 1 gram of intravenous tranexamic acid (TXA) before tourniquet inflation and 1 gram of IV TXA before closure of the incision.
15905623|NCT03606096|Biological|Boostrix IPV infant acellular Pertussis|mother is randomized to receive Boostrix ® Polio (GSK) and infant acellular pertussis
15905624|NCT03606096|Biological|Boostrix IPV infant whole Pertussis|mother is randomized to receive Boostrix ® Polio (GSK) and infant whole Pertussis
15905625|NCT03606096|Biological|TT infant acellular Pertussis|mother is randomised to receive Tetanus Toxoid and infant acellular Pertussis
15905626|NCT03606096|Biological|TT infant whole Pertussis|mother is randomised to receive Tetanus Toxoid and infant whole Pertussis
15905627|NCT03606083|Device|Endovascular repair|Endovascular repair of aorto-iliac or iliac aneurysms using an iliac branch device (IBD)
15905628|NCT03606070|Diagnostic Test|PET-MRI|"a PET-MRI examination performed before the chemoradiotherapy treatment (so-called baseline PET-MRI)
~a PET-MRI examination performed midway through treatment (PET-MRI1 under treatment), after receiving 33 ± 4 Gy (approximately 2.5 months after the first PET-MRI)."
15905629|NCT03606057|Drug|JNJ-64565111|Participants will receive JNJ-64565111, subcutaneously on days 2, 9, 16, and 23.
15905630|NCT03606057|Drug|Moxifloxacin|Participants will receive moxifloxacin capsule on days 1 or 27 in a nested crossover manner.
15905631|NCT03606057|Drug|JNJ-64565111-matching Placebo|Participants will receive JNJ-64565111-matching Placebo vehicle solution subcutaneously on days 2, 9, 16, and 23.
15905632|NCT03606057|Drug|Moxifloxacin-matching Placebo|Participants will receive moxifloxacin-matching placebo capsule on days 1 and 27 in treatment group 1 and on day 1 or 27 in treatment group 2.
15905633|NCT03606044|Device|3D-models|"The study radiologist will generate a patient-specific virtual 3D model of the participant's body from their pre-operational medical scans (CT, and MRI if available) using regulated commercial medical image analysis software, specifically Osirix MD 9.0 (Pixmeo, Geneva, Switzerland).(Rosset et al. 2004)
~The CRFw checks that the medical scan segmentation is accurate and validates the virtual 3D model.
~The surgeon checks that the medical scan segmentation is accurate and validates the virtual 3D model.
~The surgeon uses all available medical scan data, and the virtual 3D model as an adjunct, to assess the patient anatomy and plan the operation accordingly"
15905634|NCT03606018|Drug|Insulin Lispro Mix 25|insulin lispro biphasic in doses 0.4 ME/kg
15905635|NCT03606018|Drug|Humalog® Mix 25|insulin lispro biphasic in doses 0.4 ME/kg
15905636|NCT03605992|Other|Home-based Rehab|This intervention will have the duration of 12 weeks, with a total of 60 sessions: 2 supervised and 58 at home (to complete five exercise's sessions for week).
15905637|NCT03605992|Other|CentreRehab|This intervention will last 12 weeks, with a total of 60 sessions: 24 supervised and 36 at home (to complete five exercise's sessions for week).
15905638|NCT03605940|Combination Product|Methoxsalen + ECP device|2 sessions per week during 4 weeks and 1 session per week during 8 weeks
15905639|NCT03605940|Drug|Corticosteroids|2 mg/kg/day
15905640|NCT03605927|Drug|BMS-986004|BMS-986004 will be administered in ascending dose cohorts in the phase I component of the trial. Based on prior PK and PD data, dose levels of 225 mg, 675 mg, and 1500 mg (3 total phase I dose levels) will be examined. BMS-986004 will be given intravenously (IV) every 2 weeks, starting from day -3 (i.e., three days prior to HCT) onward through a total of 100 days post-HCT. The maximum tolerated dose (MTD) identified in the phase I component of the trial will be carried forward as the recommended phase II dose.
15905641|NCT03605927|Drug|Sirolimus|"Sirolimus and tacrolimus (standard of care pharmacologic immune suppression) will be given according to institutional standards.
~Sirolimus (SIR) will be given as a loading dose on day -1 orally, then daily as maintenance therapy with target levels of 10-14ng/mL early post-HCT, then tapered to 5-14ng/mL range.
~Program standards will be used for SIR and TAC level monitoring frequency and dose adjustments, including careful attention to drug-interactions."
15905642|NCT03605927|Drug|Tacrolimus|"Sirolimus and tacrolimus (standard of care pharmacologic immune suppression) will be given according to institutional standards.
~In brief, tacrolimus (TAC) will be started on day -3 IV, and transitioned to oral TAC when oral medications are tolerated; target level is 3-7ng/mL.
~Program standards will be used for SIR and TAC level monitoring frequency and dose adjustments, including careful attention to drug-interactions."
15905644|NCT03605914|Drug|Norco|The opioid used in this study is Norco. Norco is a combination medication that contains both an opioid pain reliever (hydrocodone) and a non-opioid pain reliever (acetaminophen).
15905645|NCT03605901|Drug|Standard dosing of methadone|Subject will receive 0.2 mg/kg based on ideal body weight of methadone after the intubation and before positioning.
15905646|NCT03605901|Drug|Aliquots of methadone titrated to apnea|Subjects will receive incremental aliquots of methadone up to 0.5 mg/Kg based on ideal body weight titrated to apnea. Each subject will receive a 10 mg loading dose then aliquots of 5mg each, given at 3 to 5 minute time intervals.
15905647|NCT03605888|Behavioral|Koa Family|"Koa Family is a 6-month program consisting of a whole-person lifestyle program (WPLP) combined with text messaging and social media support and a neighborhood tree planting campaign. The WPLP will bring groups of 8 to 10 mothers living in the same community together for 22 weekly 90-minute support sessions. Each session will cover a topic on whole-person living, including healthy eating, physical activity, stress reduction, coping, and well-being. Participants will receive brief text messages on their cell phones to encourage healthy lifestyle choices. Participants also will be invited to join a secret Facebook group where they can support one another in healthy lifestyle change. Finally, participants will have an opportunity to take part in a neighborhood tree planting campaign."
15905648|NCT03605875|Behavioral|Web-App|Cambian IT Health solutions from Surrey BC developed the infrastructure
15905649|NCT03605875|Behavioral|Paper|Contains similar questions to the Web-App tool
15905650|NCT03605862|Drug|Nitazoxanide|Nitazoxanide 600 mg administered orally twice daily for five days
15905651|NCT03605862|Drug|Placebo|Placebo administered orally twice daily for five days
15905652|NCT03605849|Drug|Centanafadine SR|200 mg, BID, oral tablets
15905656|NCT03605823|Device|Express Mini shunt|Implantation of Express Mini shunt through pars plana in vitrectomized eyes
15905657|NCT03605810|Other|No Intervention|This study is the development of algorithms/models to predict eGFR values and/or classes for patients at certain time point based on entries in claims database (demographic characteristics, clinical diagnoses, procedures and drug treatments) for a general population and a variety of use-cases (AF, CAD, T2DM patients sub-populations).
15905658|NCT03605797|Other|follow up of cases fixed by posterior tension band plate|Follow up of the reduction and functional outcome evaluation using the Majeed functional outcome score
15905659|NCT03605771|Other|Daily Clinical Practice|The assignment of a patient to a specific therapeutic strategy will not be decided in advance by the study protocol, but will be determined by the usual clinical practice of medicine, and the decision to prescribe a specific treatment will be clearly dissociated from the decision to include a patient in the study. No intervention will be applied to patients, either diagnostic or follow-up, other than the usual clinical practice.
15905660|NCT03605758|Drug|Ivermectin|Ivermectin is an anti-parasitic
15905661|NCT03605745|Device|Prostatic Vapor Ablation|"Rezūm uses the stored thermal energy in water vapor (steam) to treat the extra prostate tissue that is causing symptoms such as frequency, urgency, irregular flow, weak stream, straining and getting up at night to urinate.
~Inside a hand-held device, radiofrequency energy is applied to a few drops of water to create vapor (steam). The water vapor is injected into the prostate tissue that is blocking the flow of urine from the bladder, where it immediately turns back to water, releasing the energy stored in the vapor into the cell membranes. At this point, the cells are gently and immediately damaged, causing cell death. Over time, the body absorbs the treated tissue through its natural healing response."
15905662|NCT03605732|Behavioral|self help sleep hygiene intervention application|This intervention lasts for six weeks. The intervention is App-based and mainly consists of the most potent CBT techniques as well Health action process approach. Weekly feedback is provided by health psychologists.
15905663|NCT03605732|Other|patients education|Participants in the PE group will receive written weekly information on accurate and relevant information regarding insomnia symptoms, physiological controls of sleep, sleep hygiene practices, healthy sleep behaviors
15905664|NCT03605719|Drug|Carfilzomib|Given IV
15905665|NCT03605719|Drug|Dexamethasone|Given IV
15905666|NCT03605719|Biological|Nivolumab|Given IV
15905667|NCT03605719|Biological|Pelareorep|Given IV
15905668|NCT03605706|Drug|SHR-1210|Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks
15905669|NCT03605706|Drug|FOLFOX4|Subjects receive FOLFOX4 treatment on D1-D2 of every 2 weeks
15905670|NCT03605706|Drug|Placebo|Subjects receive placebo of SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks
15905671|NCT03605693|Behavioral|Written Exposure Therapy|Written exposure therapy is a 5 session treatment in which participants write about their trauma event in a specified manner.
15905672|NCT03605680|Drug|Centanafadine SR|100 mg, BID, oral tablets
15905673|NCT03605680|Other|Placebo|BID, oral tablet.
15905674|NCT03605680|Drug|Centanafadine SR|200 mg, BID, oral tablets
15905677|NCT03605654|Biological|MDR-102|Enriched CD34+ hematopoietic stem cells and defined dose of CD3+ T-cells
15905678|NCT03605654|Drug|Immunosuppressive Agents|Standard Anti-Rejection Medications that would be given to kidney transplant recipients who are outside the study
15905679|NCT03605641|Other|JUUL|JUUL Virginia Tobacco
15905680|NCT03605641|Other|VUSE Solo|VUSE SOLO Original
15905681|NCT03605641|Other|Conventional Cigarette|Subject preferred conventional cigarette
15905682|NCT03605628|Other|measuring tape|measurement of change in abdominal wall length [cm] during neuromuscular block with a measuring tape.
15905683|NCT03605628|Other|neuromuscular block|Measurement of the time course of the neuromuscular block: neuromuscular transmission is measured by assessment of the post tetanic count and the train of four ratio using acceleromyography (TOF Watch SX™, Essex Pharma GmbH, Munich, Germany) at the right adductor pollicis muscle with transcutaneous Ag/AgCl electrodes (electrocardiogram electrodes; Ambu Inc., MD 21060 USA);
15905739|NCT03605069|Drug|QR-313|QR-313 will be applied topically once daily for 8 weeks of treatment.
15905684|NCT03605628|Other|Surgical rating score|"assessment of operating conditions by means of a standardized score: surgical rating score:
~extremely poor conditions
~poor conditions
~acceptable conditions
~good conditions
~optimal conditions"
15905685|NCT03605615|Other|vocalization|The vocalization will be taught in voice form exhaled / sung in grave tones with the vowels, A, O and U.
15905686|NCT03605602|Other|No treatment is included in this protocol.|No drug intervention or tissue sampling will be included in this study.
15905687|NCT03605589|Drug|Blinatumomab|Continuous IV infusion
15905688|NCT03605589|Drug|Pembrolizumab|IV infusion
15905689|NCT03605576|Procedure|Fu's subcutaneous needling|"Fu's Subcutaneous Needle (FSN), is an innovation for the treatment of myofascial pain and trigger points. The needle is a non-injection needle, and the fact that both needles are manipulated and act on soft connective tissue.
~FSN abstains from the muscle and deep fascia layers and is confined to only the subcutaneous layer where collagen fibers are most abundant. As the subcutaneous layer is poorly innervated, pain is less than other needling therapies.
~FSN is also currently being used successfully to treat non-musculoskeletal conditions."
15905690|NCT03605576|Procedure|Transcutaneous electrical nerve stimulation|"Transcutaneous electrical nerve stimulation (TENS or TNS) is the use of electric current produced by a device to stimulate the nerves for therapeutic purposes.
~TENS, by definition, covers the complete range of transcutaneously applied currents used for nerve excitation although the term is often used with a more restrictive intent, namely to describe the kind of pulses produced by portable stimulators used to treat pain. The unit is usually connected to the skin using two or more electrodes. A typical batteryoperated TENS unit is able to modulate pulse width, frequency and intensity. Generally TENS is applied at high frequency (>50 Hz) with an intensity below motor contraction (sensory intensity) or low frequency (<10 Hz) with an intensity that produces motor contraction."
15905691|NCT03605563|Procedure|Fu's subcutaneous needling|"Fu's Subcutaneous Needle (FSN), is an innovation for the treatment of myofascial pain and trigger points. The needle is a non-injection needle, and the fact that both needles are manipulated and act on soft connective tissue.
~FSN abstains from the muscle and deep fascia layers and is confined to only the subcutaneous layer where collagen fibers are most abundant. As the subcutaneous layer is poorly innervated, pain is less than other needling therapies.
~FSN is also currently being used successfully to treat non-musculoskeletal conditions."
15905692|NCT03605563|Procedure|Transcutaneous electrical nerve stimulation|"Transcutaneous electrical nerve stimulation (TENS or TNS) is the use of electric current produced by a device to stimulate the nerves for therapeutic purposes.
~TENS, by definition, covers the complete range of transcutaneously applied currents used for nerve excitation although the term is often used with a more restrictive intent, namely to describe the kind of pulses produced by portable stimulators used to treat pain. The unit is usually connected to the skin using two or more electrodes. A typical batteryoperated TENS unit is able to modulate pulse width, frequency and intensity. Generally TENS is applied at high frequency (>50 Hz) with an intensity below motor contraction (sensory intensity) or low frequency (<10 Hz) with an intensity that produces motor contraction."
15905693|NCT03605550|Drug|PTC596|Oral tablets
15905694|NCT03605550|Radiation|Radiotherapy|Course 1
15905695|NCT03605537|Drug|Drug-eluting Stent Mometasone|The subject will have a mometasone drug-eluting stent placed during their choanal atresia repair procedure instead of no stent being placed.
15905696|NCT03605524|Other|Sensory training|12 weeks sensory training
15905697|NCT03605511|Diagnostic Test|ADAMTS 13, complement and angiogenic biomarkers|ADAMTS 13, complement and angiogenic biomarkers
15905698|NCT03605485|Device|Nasal Pillows CPAP mask|Investigative Nasal pillows Mask to be used for OSA therapy
15905699|NCT03605472|Other|cervical ultrasound|cervical ultrasound will be realized by a endocinologist trained in the cervical ultrasound
15905700|NCT03605459|Device|Comfort Plug™|
15905701|NCT03605446|Dietary Supplement|Biscuit acceptance|Acceptance of high protein biscuits
15905702|NCT03605433|Drug|Rivaroxaban|Rivaroxaban 2.5 mg or Rivaroxaban 20 mg or no oral anticoagulation
15905703|NCT03605420|Other|Family visit prior to hospital admission|Family receiving one visit prior to hospital admission for surgery
15905704|NCT03605407|Other|Patient visit prior to hospital admission|Patient and family receiving one visit prior to hospital admission for surgery
15905705|NCT03605368|Behavioral|Virtual Reality Intervention|Floreo's Police Safety Module (PSM) offers a supervised VR experience for people with ASD. The software is an application that provides a 3D immersive scene for headset-compatible smartphones. The person with ASD will use a smartphone capable of running the application with a dedicated headset providing the virtual environment. The PSM provides an immersive story-based intervention that shows a fully realized and intricately detailed urban environment designed to engage the user in a virtual encounter with a law enforcement officer. The immersive VR environment engages the person with ASD as an actor in a virtual narrative, incorporating strategies from both story-based intervention and video modeling. The video demonstrates the approach and initial engagement efforts of two police officers in the virtual environment, from the perspective of the person wearing the headset. The PSM allows a monitoring therapist to use a tablet or phone to supervise the person's virtual world.
15905706|NCT03605368|Behavioral|Video Modeling Intervention|The video modeling intervention is a subset of the BE SAFE The Movie Curriculum Lessons (https://besafethemovie.com/curriculum/) that were selected to match Floreo PSM on length. The BE SAFE The Movie Curriculum consists of video-based instruction on police officer interaction expectations and safety. Within each of three sessions, participants will watch videos, complete worksheets, and discuss topics related to police safety knowledge and behaviors with the study administrator.
15905707|NCT03605342|Drug|Buprenorphine|Participants will be started at a dose of 2mg/0.5 mg BUP/NLX and this dose will be increased as needed for stabilization of opioid withdrawal symptoms up to 24 mg per day, which is standard practice.
15905708|NCT03605342|Behavioral|Cognitive Processing Therapy (CPT)|CPT-C is a manualized, 12-session 1:1 cognitive therapy that has been designed for patients with PTSD. In this study the sessions will be conducted weekly. CPT-C uses Socratic questioning targeting distorted cognitions such as self-blame, hindsight bias, and other guilt cognitions. CPT-C is focused on the cognitive components of the therapy without exposure.
15905740|NCT03605069|Drug|Placebo|Placebo will be applied topically once daily for 8 weeks of treatment.
15905741|NCT03605056|Drug|chidamide|20 mg/d, will be administered orally, on Days 1, 4, 8, 11 of each 21 day cycle
15905709|NCT03605342|Behavioral|Individual Drug Counseling (IDC)|IDC will serve as the control group. The current standard of treatment for Veterans entering buprenorphine maintenance is to do drug counseling. Standard counseling is the primary means to achieve goals. IDC uses a semi-structured, time-limited addictions-counseling model in a 1:1 setting. The IDC manual provides an organized, concise version of what is currently practiced by most addiction counselors.
15905710|NCT03605329|Other|to explore the severity of NAC in case of OSAS|"After overnight polysomnography, cardiovascular autonomic neuropathy will be evaluated by different methods: study of HRV, cardiovascular autonomic reflex test (Ewing), measurements of urinary levels of catecholamines and measurements of sweat gland dysfunction using Sudoscan.
~The severity of CAN will be evaluated in T1D patients with moderate to severe OSAS (apnea hypopnea index (IAH) ≥15 / hour) compared to T1D patients with IAH <15 / hour."
15905711|NCT03605316|Procedure|Deep brain stimulation (DBS)|Neurosurgical treatment by stereotactic implantation of electrodes in the brain that affects the functioning of subcortical neuronal circuits
15905712|NCT03605303|Device|Test/Control|Subjects that are between the ages of 18-70 years old and habitual wearers of hydrogel daily disposable contact lenses will be randomly assigned to Test/Control sequence with a 7 to 9-day washout period in between treatments
15905713|NCT03605303|Device|Control/Test|Subjects that are between the ages of 18-70 years old and habitual wearers of hydrogel daily disposable contact lenses will be randomly assigned to Control/Test sequence with a 7 to 9-day washout period in between treatments
15905714|NCT03605290|Diagnostic Test|REHAGAIT ANYLIZER|Gait analysis instrumentation
15905715|NCT03605277|Drug|Asciminib|40 mg single dose
15905716|NCT03605251|Drug|TAS5315 low dose|Oral administration for 12 or 36 weeks
15905717|NCT03605251|Drug|TAS5315 high dose|Oral administration for 12 or 36 weeks
15905718|NCT03605251|Drug|Placebos|Oral administration for 12 weeks (At Week 12, participants in the placebo group will be assigned to TAS5315 low or high dose group)
15905719|NCT03605238|Biological|Corticosteroids & tanCART19/20|Twelve days of high-dose IV methylprednisolone (1000mg×3 days, 500mg×3 days, 240mg×3 days, 120mg×3 days) before anti-CD19/20 CAR T cells infusion. The dose is 1E5~2E6 anti-CD19/20-CAR positive T cells. The cells infusion process may last for 30 min.
15905720|NCT03605225|Device|mobile cellphone application test|Placement of cellphone on the patient´s hand and recording accelerometric data during elicited muscular contractions.
15905721|NCT03605212|Drug|Febuxostat|Intervention is orally administered to patients in this arm.
15905722|NCT03605199|Drug|Denosumab|Denosumab will be given in a dose of 120mg subcutaneously (SC) on day 1 of every 4 week cycle with a loading dose of 120mg SC on days 8 and 15 of the first cycle.
15905723|NCT03605186|Other|Chamomile oral cryotherapy|The infusion of chamomile will be prepared in the clinic with 400 mL of distilled water and 10 g of chamomile flowers (Chamomile classic infusion, Royal Herbs). Patients are asked to swish the chamomile ice cubes around their oral cavities starting 5 minutes before chemotherapy infusion, continuing 30 minutes throughout the session and for additional 35 minutes after completion of intravenous chemotherapy session.
15905724|NCT03605186|Other|Oral cryotherapy|The plain icecubes will be prepared in the clinic with 400 mL of distilled water. Patients are asked to swish the ice cubes around their oral cavities starting 5 minutes before chemotherapy infusion, continuing 30 minutes throughout the session and for additional 35 minutes after completion of intravenous chemotherapy session.
15905725|NCT03605173|Diagnostic Test|free vitamin d test|using the patient's blood serum ELISA test for free vitamin d can be performed
15905726|NCT03605173|Diagnostic Test|total vitamin d|routinely measured from serum
15905727|NCT03605160|Procedure|traditional polish|After phacoemulsification and I/A, switch to polish mode and use I/A instrument to remove the RLFs visible on the posterior capsule before injection of viscoelastic agent. IOP: 55mmHg; Aspiration: 0-10; Vacuum: 0-20. The standard for stopping polish is that the RLFs can no longer be absorbed by the side holes on the I/A instrument in this mode, or there are no discernible RLFs on the posterior capsule. If RLFs on the posterior capsular are found after IOL implantation, polish to remove them after the removal of viscoelastic agents.
15905728|NCT03605160|Procedure|fluid-jet|After phacoemulsification and I/A, inject viscoelastic agent and implant IOL without polish. Use I/A instrument to remove viscoelastic agent. A 27G irrigating syringe was used, and the RLFs on the posterior capsule were gently aligned to make a fluid-jet basically parallel to the iris. The liquid pressure of 50-120 mmHg is produced. The standard for stopping in this mode is that the RLFs can no longer be washed down from the capsule, or there are no discernible RLFs on the posterior capsule.
15905729|NCT03605147|Dietary Supplement|CaHMB|Supplements, labeled only with the identification number of the participant, will be provided to the participants in the Department of Gastroenterology of Zhongshan Hospital. After 4 weeks, subjects will receive medical center visit to evaluate the compliance and side effects. After 12 weeks, changes in body composition will be assessed by abdominal CT. An online application will be used to monitor the compliance everyday.Their diets will be recorded by a nutritionist. Blood will be collected pre- and post treatment. Extensive laboratory tests will be performed.
15905730|NCT03605147|Dietary Supplement|Placebo|Supplements, labeled only with the identification number of the participant, will be provided to the participants in the Department of Gastroenterology of Zhongshan Hospital. After 4 weeks, subjects will receive medical center visit to evaluate the compliance and side effects. After 12 weeks, changes in body composition will be assessed by CT. An online application will be used to monitor the compliance everyday.Their diets will be recorded by a nutritionist. Blood will be collected pre- and post treatment. Extensive laboratory tests will be performed.
15905731|NCT03605134|Diagnostic Test|level of cardiac troponin|blood test
15905732|NCT03605134|Diagnostic Test|diastolic function assessment|transthoracic echocardiography
15905733|NCT03605121|Procedure|cardiac surgery|The relationship between body mass index or waist circumference and clinical outcome in patients undergoing cardiac surgery will be assessed
15905734|NCT03605108|Dietary Supplement|Probiotic|"• Probiotic fomula per capsule:
~2 Billion CFUs
~HU36 - 30 mg
~HU58 - 20 mg
~Bacillus clausii -25 mg
~Bacillus coagulans 10B - 35 mg
~Prepro - 22 mg. The prebiotic that is to be used in the proprietary blend is a vegetable grade cellulose."
15905735|NCT03605108|Other|Placebo|Rice flour only
15905736|NCT03605095|Drug|nitroglycerin|Vasodilatator solution is dropped on the gingiva.
15905737|NCT03605082|Drug|UCB0107|"Pharmaceutical form: solution for infusion
~Route of administration: intravenous use"
15905743|NCT03605056|Drug|dexamethasone|40mg weekly, will be administered orally or intravenously
15905744|NCT03605043|Other|Blood pressure management in the HIV program|Integrated care for hypertension and HIV in the HIV program
15905745|NCT03605030|Device|Novel Lead Based Armboard|Novel Lead Based Armboard
15905746|NCT03605030|Device|Standard Armboard|Standard Armboard (without lead)
15905753|NCT03604978|Biological|Ipilimumab|Given IV
15905754|NCT03604978|Biological|Nivolumab|Given IV
15905755|NCT03604978|Radiation|Stereotactic Radiosurgery|Undergo multi-fraction stereotactic radiosurgery
15905756|NCT03604965|Drug|GP+CCRT|Patients receive Neoadjuvant gemcitabine (1000mg/m2 on day1 and day8 ) and cisplatin (80mg/m2 on day1)every 21days for three cycles followed by concurrent cisplatin (100mg/m2 on day1 or day2)every 21 days for three cycles during radiotherapy
15905757|NCT03604965|Drug|TPF+CCRT|Patients receive Neoadjuvant Docetaxel (75mg/m2 on day1 03:30-04:30) and cisplatin (75mg/m2 on day 1-5 10:00-22:00) and 5-FU(750mg/m2 on day 1-5 22:00-10:00) every 21days for three cycles followed by concurrent cisplatin (100mg/m2 on day1 or day2)every 21 days for three cycles during radiotherapy
15905758|NCT03604952|Diagnostic Test|COPD patients|Tests performed one week before Ramadan (C), and during the second (R-2) and the fourth weeks of Ramadan (R-4)
15905759|NCT03604939|Diagnostic Test|Evaluation of social, cultural and behavioral factors|Evaluation of the social, cultural and behavioral factors that impact the uptake of the NCD prevention and control services among women, using the RARE methodology
15905760|NCT03604939|Diagnostic Test|Evaluation of the feasibility and acceptability of delivery of early detections services|Evaluation of the feasibility and acceptability of delivery of the NCD early detections services by the trained community health workers at home settings
15905761|NCT03604913|Procedure|Aortic valve sparing operation|Aortic valve sparing instead of replacement during aortic root replacement
15905762|NCT03604913|Procedure|Bentall operation|Aortic root replacement with replacement of aortic valve
15905763|NCT03604887|Diagnostic Test|ultrasonography|"Ultrasound evaluation will be done with transducer abdominal probe. The amount of amniotic fluid and umbilical cord sections will be determined by evaluating the images obtained from the sagittal plane in the ultrasound evaluations in the 4 abdominal quadrants.
~When the anatomical structure of the umbilical cord is considered, it is folded in amniotic fluid. The folds appear as umbilical cord rings, side-by-side at the sagittal sections.
~Scoring of umbilical cord length index
~1 point will be given for each quadrant where the umbilical cord was observed.
~0.5 point will be given for each umbilical cord ring in one quadrant. Every quadrant will be evaluated in this manner, and the total score will be calculated."
15905764|NCT03604874|Drug|Oxytocin|intravenous infusion
15905765|NCT03604861|Other|Not applicable - no defined intervention|Participants who received at least one injection of RBP-6000 or placebo and either withdrew from or completed the Phase III clinical program which included studies NCT02357901 (RB-US-13-0001) and NCT02510014 (RB-US-13-0003) were eligible for the RECOVER Study.
15905766|NCT03604848|Drug|WHO-approved MDR-TB regimen|Pyrazinamide 33-50kg 1000-1750 mg daily, 51-70kg 1750-2000 daily, >70kg 2000-2500mg daily; Amikacin 600mg daily ; Moxifloxacin 33-50kg 400 mg daily, 51-70kg 600mg daily, >70kg 800mg daily; Prothionamide 33-50kg 500 mg daily, 51-70kg 750 daily, >70kg 1000 mg daily ; Cycloserine 33-50kg 500 mg daily, 51-70kg 750 daily, >70kg 1000 mg daily All treatment is taken daily.
15905767|NCT03604848|Drug|NGS-guided regimen: Regimen A|Pyrazinamide 33-50kg 1000-1750 mg daily, 51-70kg 1750-2000 daily, >70kg 2000-2500mg daily; Amikacin 600mg daily ; Moxifloxacin 33-50kg 400 mg daily, 51-70kg 600mg daily, >70kg 800mg daily; Prothionamide 33-50kg 500 mg daily, 51-70kg 750 daily, >70kg 1000 mg daily ; Cycloserine 33-50kg 500 mg daily, 51-70kg 750 daily, >70kg 1000 mg daily All treatment is taken daily.
15905768|NCT03604848|Drug|NGS-guided regimen: Regimen B|Pyrazinamide 33-50kg 1000-1750 mg daily, 51-70kg 1750-2000 daily, >70kg 2000-2500mg daily; Amikacin 600mg daily ; Moxifloxacin 33-50kg 400 mg daily, 51-70kg 600mg daily, >70kg 800mg daily; Prothionamide 33-50kg 500 mg daily, 51-70kg 750 daily, >70kg 1000 mg daily ; Cycloserine 33-50kg 500 mg daily, 51-70kg 750 daily, >70kg 1000 mg daily All treatment is taken daily.
15905769|NCT03604848|Drug|NGS-guided regimen: Regimen C|"Based on the drug susceptibility test results, the resistant drug(s) will be replaced by the other WHO recommended drugs for MDR-TB such as linezolid, clofazimine or ethambutol.
~The dose of linezolid, clofazimine or ethambutol as follows:
~Linezolid: 600 mg daily, clofazamine: 33-50kg 50 mg daily, 51-70kg 100 daily, >70kg 100 mg daily; ethambutol: 33-50kg 800 mg daily, 51-70kg 800 daily, >70kg 1200 mg daily;"
15905770|NCT03604835|Other|No Intervention|Access to any treatment is through authorized commercial use or available expanded access programs only and not as a part of this DMP.
15905771|NCT03604822|Procedure|Music therapy|ALS-specific, individualized MT protocol was delivered to study participants in their homes twice weekly for the duration of six weeks by the researcher. Facilitating music structures were composed by the researcher to support cueing, timing and intensity of breathing and vocalization exercises. These structures were regularly modified to suit the unique capabilities, current individual demands and progress of each participant. One familiar song, selected by the participant, was used for each participant in therapeutic singing exercise closing each session. Individualized exercises sets for independent practice were provided at session 3 to each participants. ALS-specific voice health guidelines were provided for participants prior to start of the treatment.
15905810|NCT03604471|Drug|Atorvastatin|Blood sampling for atorvastatin quantification and pharmacogenetic analysis.
15905811|NCT03604445|Drug|BI 905677|Solution for infusion
15905812|NCT03604419|Drug|PB-119 100 μg+ Glucophage®|Each patient will subsequently be randomized within the designated cohort to active drug or placebo
15905813|NCT03604419|Drug|PB-119 150 μg+ Glucophage®|Each patient will subsequently be randomized within the designated cohort to active drug or placebo
15905814|NCT03604419|Drug|PB-119 200 μg+ Glucophage®|Each patient will subsequently be randomized within the designated cohort to active drug or placebo
15905815|NCT03604419|Drug|PB-119 placebo + Glucophage®|Each patient will subsequently be randomized within the designated cohort to active drug or placebo
15905772|NCT03604809|Other|OT Guided Cognitive Interventions|"RASS is defined as the level of sedation and agitation of a patient. Cognitive interventions are evidence based strategies that enhance the cognition of patients and include memory training using visual imagery; metacognitive training using self-awareness and self-regulation approaches for recovery of executive functioning; and neuropsychological rehabilitation to help improve cognitive and functional deficits. Interventions will be adjusted according to the RASS score. Cognitive interventions include discussion of patient status and education of family around reorientation, cognitive screening and graded exercises according to patient ability. The deepest levels of sedation and highest levels of agitation will be included in the intervention arm.
~Interventions will be provided by the Occupational Therapist; Monday to Friday, BID, 20 minutes per session, for the duration of ICU admission."
15905773|NCT03604796|Drug|Rectal Solution|Rectal acetaminophen at 15 mg/kg x 4/day for three days
15905774|NCT03604796|Drug|Intravenous Infusion|Loading dose of 15 mg/kg IV acetaminophen followed by a continuous infusion at a rate of 2.5 mg/kg/hr for 72 hours
15905775|NCT03604783|Drug|TP-1287|TP-1287 by oral administration
15905776|NCT03604770|Other|Survey & Food Diary|Patients will be provided with a 8 question patient survey to complete and return, as well as a food diary that they will complete over a 3 day period to assess their average caloric intake.
15905777|NCT03604757|Drug|68Ga-PSMA-617 PET/CT|PET/CT Imaging with 68Ga-PSMA-617 injection
15905778|NCT03604757|Drug|68Ga-RM2 PET/CT|PET/CT Imaging with 68Ga-RM2 injection
15905779|NCT03604744|Drug|LSD|LSD 0.1 mg per os, single dose
15905780|NCT03604744|Drug|LSD|LSD 0.2 mg per os, single dose
15905781|NCT03604744|Drug|Psilocybin|Psilocybin 15 mg per os, single dose
15905782|NCT03604744|Drug|Psilocybin|Psilocybin 30 mg per os, single dose
15905783|NCT03604731|Device|cytokine adsorbtion during extracorporeal circulation|preventive use of cytokine adsorption and modulation of the cytokine response in the course of artificial circulation
15905784|NCT03604718|Biological|Beltavac® Polymerized with Alternaria alternata|Adminstration of Beltavac® Polymerized with Alternaria alternata according to the routine clinical practice
15905785|NCT03604705|Drug|APX001|APX001
15905786|NCT03604692|Drug|SNDX-6352|SNDX-6352 is a high affinity antibody targeting the colony stimulating factor 1 receptor (CSF-1R). CSF-1R signaling has been demonstrated in nonclinical studies to be the key regulatory pathway involved in the expansion and infiltration of donor derived macrophages that mediate the disease processes involved in cGVHD.
15905787|NCT03604679|Drug|SyB C-0501|Specified dose on specified days
15905788|NCT03604666|Other|Health care process with Nurse Navigator|"A Nurse Navigator will:
~Be present at the announcement consultation
~Give information on the outpatient circuit
~Offer assistance for patients over 75 years
~Complete onco-geriatric orientation questionnaires
~Take care of patients on the ambulatory circuit"
15905789|NCT03604653|Device|HIPEC|Heated chemotherapy is pumped into the abdomen and circulated for 90 minutes
15905790|NCT03604653|Drug|Mitomycin c|MMC 30mg@ T0, 10mg@T45 min
15905791|NCT03604653|Drug|CDDP 50|50mg/m2@T0
15905792|NCT03604653|Drug|CDDP 75|75mg/m2@T0
15905793|NCT03604653|Drug|Doxorubicin|15mg/m2@T0
15905794|NCT03604640|Other|Physical Training|Physical exercise program and health education
15905795|NCT03604627|Other|Coronal calcium score measurement|"A medical interview with clinical examination by a cardiologist for screening cardiovascular risk factors, including smoking, and looking for symptoms of heart disease as part of routine care.
~In accordance with routine care, a fasting and fasting blood test will be performed performed on exam day at Bichat Hospital or at another time, close to the patient's home according to his availability. The biological blood test will include the measurement of plasma triglyceride concentrations, total cholesterol and its HDL and LDL fractions, blood glucose, glycated hemoglobin and serum creatinine with estimated glomerular filtration rate according to the CKD-EPI formula. . Sample urinalysis will include measurement of creatinine, proteinuria, and microalbuminuria.
~An electrocardiogram (ECG) rest, a cardiac ultrasound, a test and respiratory function tests (EFR) will be performed as part of routine care. Coronal calcium score measurement will be performed as part of the research."
15905796|NCT03604614|Drug|Hyperthermic Intraperitoneal Chemotherapy|The investigators use Paclitaxel as peritoneal hyperthermic perfusion chemotherapy drugs，75mg/m2 for the first time，50mg/m2 for the second time and third time.The chemotherapy is SOX(Tiggio d1-d14 bid po and Oxaliplatin 130mg/m2 ivd d1 qd).The Tiggio dosage depends on the patient's body surface area, body surface area <1.25m2 40mg/time, 1.25-1.50m2 50mg/time, >1.50m2 60mg/time.
15905797|NCT03604614|Drug|Without Hyperthermic Intraperitoneal Chemotherapy|The chemotherapy is SOX(Tiggio d1-d14 bid po and Oxaliplatin 130mg/m2 ivd d1 qd).The Tiggio dosage depends on the patient's body surface area, body surface area <1.25m2 40mg/time, 1.25-1.50m2 50mg/time, >1.50m2 60mg/time.
15905798|NCT03604601|Procedure|salvage surgery|Salvage surgery hopes to control the recurrence of larynx, pharynx, fistula and neck tumor and improve the quality of life and survival rate
15905799|NCT03604588|Diagnostic Test|HPV OncoTect™|"Salivary specimens will be collected from 40 patients with oropharyngeal cancer The saliva samples will be sent to incell dx, which will analyze them blindly (without knowledge of the clinicopathological information) with the HPV OncoTect ™ test.
~Clinical and pathological information will be collected and maintained by the principal investigator At the end of the study, the results obtained with the HPV OncoTect ™ test will be confronted with the clinical and pathological results."
15905800|NCT03604575|Drug|Insulin Lispro|
15905801|NCT03604575|Drug|Humalog®|
15905802|NCT03604549|Drug|Lipiodol UF|Up to 10cc of Lipiodol Ultra Fluid will be infused via intrauterine catheter
15905803|NCT03604549|Drug|Saline|Up to 10cc of saline will be infused via intrauterine catheter
15905804|NCT03604523|Device|Dilation by Balloon|Esophageal dilation by balloon device.
15905805|NCT03604523|Device|Dilation by Semi-rigid Savary|Esophageal dilation by semi-rigid savary device
15905806|NCT03604510|Procedure|Electroencephalographic recordings|24 hours of electroencephalographic recordings (EEG-Holter) of prefrontal activity of Tourette's syndrome (TS) patients in ecological conditions.
15905807|NCT03604497|Behavioral|beacon alerts|alerts via unidirectional communication from beacons to smartphones when smartphones are approaching pedestrian crossing at activated intersection
15905808|NCT03604497|Behavioral|no alerts retention|no alerts will appear, but we will measure retention of behavior learned during the active intervention stage
15905816|NCT03604406|Biological|Varicella Zoster Vaccine|live-attenuated vaccine to prevent herpes zoster
15905817|NCT03604406|Other|Placebo Injection|Saline solution injection
15905818|NCT03604406|Biological|Varicella Zoster Vaccine|non-live vaccine to prevent herpes zoster
15905819|NCT03604393|Behavioral|Practice facilitation|For this intervention, ORPRN Practice Facilitators will: 1) Build practice QI capacity by addressing the five Change Concepts; 2) Train practice clinicians and staff to generate reminder lists and notices in ALERT Immunization Information System (state immunization registry); 3) Develop an HPV immunization improvement plan for each practice using PDSA cycles and workflow mapping; and 4) Facilitate community engagement surrounding HPV vaccination messaging.
15905820|NCT03604380|Other|Computerized Plasticity-Based Adaptive Cognitive Training|Computerized plasticity-based adaptive cognitive training requiring a total maximum of 36 treatment sessions, up to 7 sessions per week, 36 minutes per session.
15905821|NCT03604380|Other|Active Comparator|Commercially available computerized training requiring a total maximum of 36 treatment sessions, up to 7 sessions per week, 36 minutes per session.
15905822|NCT03604367|Device|GAITRite assessment|The fMRI Bipedal Paradigm will allow investigators to study the effects treadmill-assisted gait training have on cortical control of bipedal movement in chronic stroke patients.
15905823|NCT03604354|Drug|Tapentadol 100 MG Oral Tablet|This arm will receive drugs one hour before undergoing unilateral total knee arthroplasty. Interventions tapentadol 100mg oral tablets.
15905824|NCT03604354|Drug|Pregabalin 150mg|This arm will receive drugs one hour before undergoing unilateral total knee arthroplasty. Interventions pregabalin 150mg oral tablets.
15905825|NCT03604341|Drug|Dronabinol 5mg Cap|Subjects randomized to Dronabinol 5mg Cap and ibuprofen 800mg for pain
15905826|NCT03604341|Other|Placebo|Subjects randomized to placebo and ibuprofen 800mg for pain
15905827|NCT03604328|Drug|PA5108|single ocular implant, administered on day 1
15905828|NCT03604315|Procedure|Computed Tomography|Undergo FDG PET/CT
15905829|NCT03604315|Procedure|Computed Tomography|Undergo [18F]FTT PET/CT
15905830|NCT03604315|Radiation|Fludeoxyglucose F-18|Given IV
15905831|NCT03604315|Radiation|Fluorine F 18 Fluorthanatrace|Given IV
15905832|NCT03604315|Procedure|Positron Emission Tomography|Undergo FDG PET/CT
15905833|NCT03604315|Procedure|Positron Emission Tomography|Undergo [18F]FTT PET/CT
15905834|NCT03604302|Device|fMRI Paradigms|T2*-weighted images will be acquired with a single-shot gradient echo echo-planar imaging (EPI) sequence in the axial orientation (TR=2500ms, TE=30ms, FA=80°, slice thickness=4 mm, FOV= 240mm2, matrix=64×64) covering the whole brain.
15905835|NCT03604289|Drug|Angiotensin-(1-7)|This is a biologically active endogenous angiotensin peptide that may play an important role in regulation of blood pressure.
15905836|NCT03604289|Drug|Saline|Saline will be used as the placebo comparator
15905837|NCT03604263|Device|ArcticLine Cardiac Cryoablation Catheter|Cryoablation
15905838|NCT03604250|Dietary Supplement|Lifestyle plus prebiotic supplement|Research participants will be asked to wear health monitoring devices, including a continuous glucose and heart-rate monitors. They may be prompted to perform lifestyle modifications aimed at better understanding their health parameters, based on the results obtained from the wearable devices and other tests. During the last 3 weeks of the study, research participants may be asked to take a personalized prebiotic supplement, up to once/day.
15905839|NCT03604237|Diagnostic Test|Targeted group|Forceps biopsy is taken after surface evaluation of the large colorectal tumors.
15905840|NCT03604224|Drug|Canagliflozin 300 mg|Participants who are initiated on canagliflozin 300 mg will be observed. No study treatment will be administered as a part of this study.
15905841|NCT03604211|Radiation|Cyberknife Radiation Therapy|Stereotactic Radiotherapy of lymphnode recurrence after prostatectomy +/- salvage radiotherapy
15905842|NCT03604198|Drug|relacorilant|CORT125134 is supplied as capsules for oral dosing.
15905843|NCT03604185|Behavioral|Choir Singing|A weekly 2-hour group choral session over fourteen weeks. Plus an optional weekly 1-hour online musical and vocal training session.
15905844|NCT03604185|Behavioral|Music Appreciation|A fourteen week course which will emphasize analytic listening to musical excerpts, and will match the choir class in terms of duration, homework demands, and instructor.
15905845|NCT03604172|Behavioral|Cognitive behavioral therapy|The cognitive behavioral therapy intervention will consist of weekly, 50-minute individual meetings for 16 weeks with a clinician trained in cognitive behavioral therapy for binge eating disorder.
15905846|NCT03604172|Behavioral|Waitlist|The waitlist group will have a 16-week waitlist period. After the waitlist period, they will be offered cognitive behavioral therapy.
15905847|NCT03604159|Drug|Buprenorphine Extended Release|XRB is available in dosage strengths of 100 mg/0.5 mL and 300 mg/1.5 mL buprenorphine. Each dose is provided in a prefilled syringe with a 19 gauge 5/8-inch needle.
15905848|NCT03604159|Drug|Sublingual Buprenorphine (SUBOXONE, Zubsolv, or generic tablets)|SLB is administered sublingually or buccally as a single daily dose. Medication should be prescribed in consideration of the frequency of visits. Provision of multiple refills is not advised in early treatment or without appropriate follow-up visits. After treatment induction and stabilization, the maintenance dose of SLB is generally in the range of 4mg/1mg buprenorphine/naloxone to 24mg/6mg buprenorphine/naloxone per day depending on the individual patient and clinical response.
15905849|NCT03604146|Behavioral|Medical quality control intervention strategy|Training and education for diagnosis, treatment and management of COPD for doctors and nurses; Regular inspection and supervision of medical quality
15905850|NCT03604120|Device|Preoxygenation with high flow therapy by nasal cannula|Preoxygenation during 4 minutes with High Flow Nasal Cannula (60l/min FiO2 = 1) before fiber-optic or laryngoscopic intubation. The device will be maintained in place throughout the intubation procedure in order to achieve oxygenation.
15905851|NCT03604120|Device|Preoxygenation by standard Facial mask|"For Fiber-optic intubation: patients will receive a 4 minutes FIBROXY facial mask preoxygenation with FiO2=100%. The FIBROXY facial mask will be maintained in place during the intubation procedure.
~For Laryngoscopic intubation: patients will receive a 4 minutes standard facial mask preoxygenation with FiO2=100%. The standard facial mask will be removed after crash induction to proceed to intubation."
15905852|NCT03604107|Genetic|Preimplantation Genetic Testing-Aneuploidy|trophectoderm biopsy samples will be analyzed for karyotype after clinical outcome is determined
15905853|NCT03604094|Procedure|Ultrasonographic evaluation|Right internal jugular vein will be evaluated with ultrasound for anatomical variations and dimensions
15905854|NCT03604081|Other|CIMT|Intervention group will receive one hour of intense massed practice of lower extremity either in the form of shaping or task practice.
15905855|NCT03604081|Other|Conventional Physical Therapy|1 hour as per current standard of care that follows stroke clinical practice guideline.
15905856|NCT03604068|Device|RecoveryRx|A pulsed shortwave therapy medical device
15905857|NCT03604068|Device|Sham RecoveryRx|A sham pulsed shortwave therapy medical device
15905858|NCT03604055|Procedure|Endobronchial hamartomas treatment|General anesthesia was administered by an intravenous anesthesia technique. Patients were intubated with a rigid bronchoscope. Debulking procedures were performed by mechanical tumor resection (MTR) using the tip of the rigid bronchoscope, rigid pliers or argon plasma coagulation assisted MTR or cryorecanalization or electrocautery - snare probe. An innovation of our study was that cryotherapy was performed in the regions where the lesions originated after debulking
15905859|NCT03604042|Combination Product|Protein fortifier|Protein Fortifier to be added to Fortified human milk according to feeding regimen
15905860|NCT03604029|Device|Near Infrared Spectroscopy|Near Infrared Spectroscopy (NIRS) sensors are applied to injured leg compartments and a control compartment to continuously measure tissue oxygenation.
15905861|NCT03604016|Drug|Besifovir dipivoxil|Besifovir dipivoxil 150 mg
15905862|NCT03604016|Drug|L-carnitine|Besifovir dipivoxil 150 mg
15905863|NCT03604016|Drug|Tenofovir Alafenamide|Tenofovir Alafenamide 25mg
15905864|NCT03604003|Drug|potassium losartan|treated with bedtime or awakening doses of potassium losartan
15905865|NCT03603990|Procedure|Vitrectomy|"During the first 6 month :Only Panretinal photocoagulation(if high-risk PDR or rubeosis iridis) may be given.
~After First Six Months : All therapies for DME may be given at the discretion of the investigator"
15905866|NCT03603990|Procedure|Usual care|"Patients with usual care according to the investigator choice :
~During the first 6 month : All therapies for DME may be given at the discretion of the investigator during the study, except a vitrectomy.
~After First Six Months : All therapies for DME may be given at the discretion of the investigator, including a vitrectomy."
15905867|NCT03603977|Drug|Lpv/r+3TC|It is a simplified therapy regimen study of lopinavir and ritonavir combined with lamivudine for HIV-1 infected patients in the real world of China.
15905868|NCT03603964|Drug|Guadecitabine|Guadecitabine
15905869|NCT03603951|Drug|SHR2554|SHR2554 is a selective small molecule inhibitor of the histone-lysine methyltransferase EZH2.
15905870|NCT03603938|Drug|potassium losartan|treated with bedtime or awakening doses of potassium losartan
15905871|NCT03603925|Diagnostic Test|Positron Emission Test / Magnetic Resonance (PET/MR)|The Philips Ingenuity PET/MR is used for research scanning. Patients receiving a clinically indicated PET/CT, will be approached to be included in this study. There is no special preparation other than that needed for the prerequisite PET/CT scanning. At the completion of the PET/CT scanning, the subject will be taken to the PET/MR scanner, which is in close in proximity, for research scanning. The research scanning would take up to one hour or as tolerated.
15905872|NCT03603925|Diagnostic Test|Positron Emission Test / Computed Tomography (PET/CT)|Patients will receive PET / CT imaging for the detection of cancer or other clinically indicated anomalies. The completed study visit is expected to take approximately 2 hours and not longer than 3 hours.
15905873|NCT03603912|Drug|Metformin|Metformin ER 500 mg daily, titrated at 1 month intervals to 500 mg twice daily, then 750 mg twice daily, as tolerated, for 2 years.
15905874|NCT03603912|Behavioral|Lifestyle/Risk Factor Modification|Diet/nutrition counseling and exercise prescription with follow-up visits, sleep apnea screening and treatment if detected, optimization of guideline-directed medical therapies for hypertension, coronary artery disease (CAD), hyperlipidemia and heart failure (HF).
15905875|NCT03603899|Drug|Hp 129Xenon|129 Xenon is a noble gas with no taste or smell. It will be made slightly magnetic (also called hyperpolarizing) and then inhaled into the lungs to provide better pictures of the lungs during MRI.
15905876|NCT03603886|Behavioral|Telemedicine Pain Management Intervention (immediate group)|Four weekly telemedicine pain management sessions with a trained provider. Intervention will be delivered via video conferencing platform, and each session will last between 30 and 45 minutes. Intervention topics will include: pain psychoeducation, pain coping tools, pain communication, and pain-related stress management.
15905877|NCT03603886|Behavioral|Telemedicine Pain Management Intervention (waitlist group, intervention administered following 4-week waitlist period)|"Four week waitlist period during which participants receive treatment as usual. Following the waitlist period, participants will receive the telemedicine pain management intervention:
~Four weekly telemedicine pain management sessions with a trained provider. Intervention will be delivered via video conferencing platform, and each session will last between 30 and 45 minutes. Intervention topics will include: pain psychoeducation, pain coping tools, pain communication, and pain-related stress management."
15905878|NCT03603860|Device|Non-invasive monitoring|Comparing blood pressure measurement using the Biobeat non-invasive monitor to arterial line
15905879|NCT03603834|Drug|mFOLFOXIRI|"mFOLFOXIRI consists of the following combination of drugs:
~Oxaliplatin, 85 mg/m2, IV over 2 hours
~Leucovorin, 400 mg/m2, IV over 2 hours
~Irinotecan, 150 mg/m2, IV over 90 minutes
~5 FU, 400 mg/m2, IV bolus
~5FU, 2400 mg/m2, IV infusion over 46 hours after 5FU bolus injection
~each 14 day cycle, for 6 cycles"
15905880|NCT03603821|Diagnostic Test|CLINICAL ASSESMENT|IPSS questionnaire, uroflowmetry, prostate and bladder ultrasonography, voiding diary, medical interview
15905881|NCT03603808|Device|Electroporation|Undergo electroporation
15905882|NCT03603808|Biological|HPV DNA Plasmids Therapeutic Vaccine VGX-3100|Given IM
15905883|NCT03603808|Other|Laboratory Biomarker Analysis|Correlative studies
15905884|NCT03603795|Drug|Eltrombopag|Eltrombopag concomitant with induction chemotherapy in patient with AML
15905885|NCT03603795|Drug|Placebo|Placebo concomitant with induction chemotherapy patients with AML
15905886|NCT03603782|Dietary Supplement|2.5% protein|2.5%
15905887|NCT03603782|Dietary Supplement|protein 5%|5%
15905888|NCT03603782|Dietary Supplement|protein 10%|10%
15905889|NCT03603782|Dietary Supplement|protein 15%|15%
15905890|NCT03603782|Dietary Supplement|A2: Peptamen 1.5 Vanilla without Breakfast|Peptamen withoug breakfast
15905891|NCT03603782|Dietary Supplement|B2: only breakfast (no product)|only breakfast
15905892|NCT03603782|Dietary Supplement|C2: 5% protein with breakfast|C2: 5% protein consumed with breakfast
15905893|NCT03603782|Dietary Supplement|D2: 5% protein 30 min before breakfast|D2: 5% protein consumed 30 min before breakfast
15905894|NCT03603769|Dietary Supplement|Food supplement capsules containing Salmon-Polar Lipids|Postprandial decreased Platelet activation/aggregation in subjects, after the food supplement capsule consumption
15905895|NCT03603769|Dietary Supplement|Placebo food supplement capsule|Postprandial unaffected platelet activation/aggregation in subjects, after the food supplement capsule consumption
15905896|NCT03603756|Drug|SHR-1210|a novel anti-PD-1 antibody
15905897|NCT03603756|Drug|Apatinib|a VEGFR-2 tyrosine kinase inhibitor
15905898|NCT03603756|Drug|Irinotecan Injection|cytotoxic agent that binds to topoisomerase I
15905899|NCT03603756|Drug|Paclitaxel liposome|cytotoxic agent that prevent depolymerization of cellular microtubules
15905900|NCT03603756|Drug|Nedaplatin|cytotoxic agent that cross-links and denatures strands of DNA
15905901|NCT03603743|Behavioral|exercise training in heart failure with HIIT|to compare MICT vs HIIT 5 days/week during 4 weeks in a Cardiovascular Centre.
15905902|NCT03603730|Device|taVNS|Active or inactive taVNS delivered to the external ear at a moderate, non-painful level.
15905903|NCT03603717|Behavioral|Cognitive Behavioral Therapy for Insomnia|The intervention will consist of a standard, structured, multi-component intervention for insomnia that includes sleep education, sleep hygiene, sleep restriction, stimulus control, and cognitive therapy.
15905904|NCT03603717|Behavioral|Sleep Hygiene|The intervention will include basic psychoeducation about sleep, discussion of sleep hygiene factors that disrupt and improve sleep, setting sleep hygiene goals, and developing action steps to achieve those goals.
15905905|NCT03603704|Drug|LY3209590|Administered SC
15905906|NCT03603704|Drug|Placebo|Administered SC
15905907|NCT03603691|Diagnostic Test|Modified Manual Muscle Test|Manual Muscle Testing Grading System from 0=No visible or palpable contraction to 5= full range of movement against gravity, maximal resistance
15905908|NCT03603691|Diagnostic Test|BMRC manual muscle test|muscle scale grades muscle power on a scale of 0 to 5 in relation to the maximum expected for that muscle
15905909|NCT03603691|Diagnostic Test|MicroFET2 handhold dynamometer|MicroFET 2 Handheld Dynamometer is a force evaluation testing device to evaluate the strength of various muscle groups
15905910|NCT03603691|Diagnostic Test|Modified Tardieu Scale|Modified Tardieu Scale is to measure if there is spasticity present in a person's muscle and its response to movement
15905911|NCT03603691|Diagnostic Test|Fatigue Scale for Motor and Cognitive Functions|Measures cognitive and motor fatigue for people with MS
15905912|NCT03603691|Diagnostic Test|numeric rating scale Fatigue|visual analog scale that uses a scalar numbering system to objectify a patient's fatigue (0 = no fatigue; 10 = most extreme fatigue)
15905913|NCT03603678|Drug|BAY2253651|100 µg (500 µg/ml * 200 µl) BAY2253651 intranasally
15905914|NCT03603678|Drug|Placebo|Matching Placebo dosing
15905915|NCT03603665|Biological|NTM-1633|NTM-1633 is an equimolar mixture of three IgG1 monoclonal antibodies (mAb), referred to as XE02, XE06, and XE17 which bind to non-overlapping epitopes on Botulinum Neurotoxin (BoNT/E). Administered as a single intravenous infusion of NTM-1633 over one hour.
15905916|NCT03603665|Other|Placebo|0.9% Sodium Chloride Injection administered as a single intravenous infusion over one hour.
15905917|NCT03603652|Device|Microwave Ablation|Ablations will be performed under general anesthesia via transbronchial approach by an interventional pulmonologist or thoracic surgeon. Prior to the ablation, the treating physician will perform an endobronchial ultrasound to confirm disease staging.
15905918|NCT03603639|Drug|Placebo|Participants will receive E2730-matched placebo capsule, orally.
15905919|NCT03603639|Drug|E2730|Participants will receive E2730 capsule, orally.
15905920|NCT03603626|Drug|Pregabalin 150mg|Preemptive pregabalin 150 mg administered 1 hour before surgery
15905921|NCT03603626|Drug|Placebo oral capsule|Placebo administered 1 hour before surgery
15905922|NCT03603613|Behavioral|YRI|The YRI is designed to assist youth facing complex problems using evidence-based treatments that have been tested and shown to work well in other settings and cultures. The YRI has three specific goals: 1) develop emotion regulation skills for healthy coping; 2) develop problem-solving skills to assist with achieving goals, and; 3) improve interpersonal skills to enable healthy relationships and effective communication. It integrates six CBT-based, empirically-supported practice elements shown to have transdiagnostic efficacy across disorders ranging from major depressive disorder to PTSD and conduct disorders. The YRI's six evidence-based components are delivered in three phases common in trauma-informed interventions: stabilization, integration, and connection.
15905923|NCT03603613|Behavioral|EPP|The youth capacity development component of GIZ's EPP includes the following core components: financial literacy, entrepreneurship, and vocational training delivered through six modules (agro-processing, solar photovoltaic installation and maintenance, governance and conflict resolution, psychosocial competencies, entrepreneurship, employability). Youth will be trained at training sites and have access to a youth center in the area. These centers will have agricultural equipment and machinery available for youth to use. Our YRI curriculum will be used for the psychosocial competency training module.
15905924|NCT03603600|Device|enVista MX60E|enVista MX60E monofocal IOL
15905925|NCT03603600|Device|enVista MX60EF|enVista MX60EF (trifocal) multifocal IOL (MIOL)
15905926|NCT03603587|Procedure|biopsy|Biopsy 4 to 5 mm from the distal part of the tips of the excision pieces. Three biopsies of 3 mm, made with punch, occipital hair zone (ZT) A completely painless sample, using a swab (soaked with a buffer solution) on the scalp of the ZH and ZT zone.
15905927|NCT03603587|Diagnostic Test|blood sample|Blood sample will be collected for performed for HIV serology, B and C hepatitis.
15905928|NCT03603587|Diagnostic Test|questionnaire on sun exposure|Questionnaire on sun exposure will be completed by patients.
15905929|NCT03603587|Diagnostic Test|examination of the scalp|A complete examination of the scalp will be completed by dermatologist.
15905930|NCT03603587|Diagnostic Test|Norwood scale|Norwood scale measure the evolution of baldness. It will be completed by dermatologist.
15905931|NCT03603587|Diagnostic Test|questionnaire of clinicals signs|Questionnaire of clinicals signs will be completed by dermatologist and patient.
15905932|NCT03603587|Diagnostic Test|scinexa score|It's a assessment score of skin aging. It will be completed by dermatologist.
15905933|NCT03603587|Diagnostic Test|questionnaire of the history of the hair loss|Questionnaire of the history of the hair loss will be completed by dermatologist and patient.
15905934|NCT03603574|Device|EWA through the needle|In the EWA-N group, 5 mL of normal saline are injected through the epidural needle after the occurrence of loss-of-resistance (LOR). The needle is connected to the pressure transducer. A satisfactory endpoint is defined as the presence of waveforms synchronized with arterial pulsations. In the absence of pulsatile waveforms, the operator injects an additional 2.5 mL-bolus of normal saline through the epidural needle and reconnects the latter to the pressure transducer. If no waveforms are detected after the second injection, the operator removes the needle and reattempts the epidural block at a different intervertebral level. A maximum of 3 levels is permitted: if waveforms are still absent at the third level, the operator simply accepts LOR as the technical endpoint.
15905935|NCT03603574|Device|EWA through the catheter|In the EWA-C group, the epidural catheter is advanced 5 cm beyond the needle tip after the occurrence of LOR. Subsequently, the operator injects 5 mL of normal saline through the catheter and the latter is connected to the pressure transducer via the sterile, rigid extension tubing. A satisfactory endpoint is defined as the presence of waveforms. In the absence of pulsatile waveforms, the operator injects an additional 2.5 mL-bolus of saline through the catheter and reconnects the latter to the pressure transducer. If no waveforms are detected after the second injection are still absent at the third level, the operator simply accepts this position for catheter placement (intent-to-treat analysis).
15905936|NCT03603561|Device|cTBS|In the cTBS arm, the patients will receive 5 daily session cTBS (5 times uninterrupted train of 900 pulses) separated by a 15 min interval. Patients will be treated with in total 20 cTBS sessions over the right dorsolateral prefrontal cortex, spread over 4 days. A stimulation intensity of 100 % of the resting motor threshold (rMT) of the right abductor pollicis brevis muscle will be used.
15905937|NCT03603561|Device|Sham cTBS|The sham coil has been specifically developed to mimic the real one but is not associated with a stimulus sensation compared to the coil delivering real stimulation cTBS.
15905938|NCT03603548|Drug|Envarsus|Patients after liver transplantation initially treated with traditional Tacrolimus variant- Prograf, switched on day 10 after OLTx on prolonged released Tacrolimus variant in 1:1 ratio ( Advagraf vs. Envarsus)
15905939|NCT03603548|Drug|Advagraf|Patients after liver transplantation initially treated with traditional Tacrolimus variant- Prograf, switched on day 10 after OLTx on prolonged released Tacrolimus variant in 1:1 ratio ( Advagraf vs. Envarsus)
15905940|NCT03603535|Device|sensiTVT|The study is designed as a prospective single arm study. All women with an indication for suburethral tape placement for therapy of SUI and meeting the inclusion criteria will be offered study participation to record the objective outcome after one year.
15905941|NCT03603522|Dietary Supplement|BioGaia-DSM17938|2mL per day (1x10^9 CFU) per day taken orally for 28 days
15905942|NCT03603522|Other|Placebo Comparator: Placebo Control|2mL per day of placebo formulation taken orally for 28 days
15905943|NCT03603509|Drug|Fluad Vaccine|FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza. disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is. approved for use in persons 65 years of age and older.
15905944|NCT03603509|Drug|Fluzone High-Dose|FLUZONE® HIGH-DOSE vaccine is indicated for people 65 years of age and older to help prevent influenza disease caused by influenza A and B strains contained in the vaccine.
15905945|NCT03603496|Behavioral|Personalized Tobacco Care Management|PTCM will provide sustained care after discharge by offering (1) 8 weeks of nicotine replacement therapy at no cost provided at hospital discharge and (2) up to 7 proactive contacts over 3 months delivered by automated IVR call, supplemented by text messaging and email (patient choice). At each contact the patient is offered a return call from the hospital-based tobacco coach who offer counseling, medication advice, and coordination of care with the patient's outpatient health care team.
15905946|NCT03603496|Behavioral|eReferral to State Tobacco Quitline|Referral from hospital to the state Quitline will be made by the research team on behalf of each enrolled patient. Feedback from the Quitline will be included in the patient's medical chart.
15905947|NCT03603496|Drug|Nicotine replacement therapy|Up to 8 weeks of nicotine replacement therapy provided at no cost to the patient.
15905948|NCT03603483|Procedure|procedure|"Patients of sever aortic stenosis 1: increase the diameter of aortic anulus by prosthetic patch or pericardial patch.
~Patients of sever aortic stenosis 1:only conventional aortic valve prosthesis will be used"
15905949|NCT03603470|Other|EOS imagery|Whole body EOS imaging in seated and standing position
15905950|NCT03603444|Other|No intervention are provided|
15905951|NCT03603431|Drug|MRG-110|Single ascending doses of MRG-110
15905952|NCT03603431|Drug|Placebo|Single doses of placebo
15905953|NCT03603431|Drug|MRG-110|Multiple ascending doses of MRG-110
15905954|NCT03603431|Drug|Placebo|Multiple doses of Placebo
15905955|NCT03603418|Drug|Dexamethasone Sodium Phosphate|Dexamethasone is a synthetic glucocorticoid that is commonly used in human medical practice as potent anti-inflammatory, immunosuppressive and analgesic agent.
15905956|NCT03603418|Other|Distilled water|Distilled water
15905957|NCT03603405|Drug|ADV/HSV-tk (gene therapy)|The investigational adenovirus gene therapy injected at tumor site followed by valacyclovir, radiotherapy, and chemotherapy
15905958|NCT03603392|Other|Physical activity program|
15905959|NCT03603379|Drug|C225-ILs-dox|C225-ILs-dox will be administered at a dose of 50 mg/m2. i.v., on day 1 of each cycle, cycle length is 28 days. In total, 4 cycles are planned to be applied.
15905960|NCT03603366|Drug|Acetylsalicylic acid (Aspirin, BAYE4465)|This study does not involve prescription of the drugs. This study is a cross-sectional survey of patients taking low-dose aspirin or patients who are eligible but not taking low-dose aspirin.
15905991|NCT03603171|Diagnostic Test|Pressure pain threshold|Thresholds for pressure pain were obtained over eight muscles on the left and right side of the body: extensor digitorum communis, deltoid, quadriceps and anterior tibialis. The average value of two measurements will be recorded.
15906035|NCT03602885|Behavioral|Chemotherapy education intervention (CEI)|Video, booklet, and website educational materials
15906036|NCT03602872|Biological|Human allogeneic mesenchymal bone marrow derived stem cells|Intraarticular administration of 20x10^6 MSCs
15905961|NCT03603353|Other|ENDS (vaporizer/e-cig) and smoking cessation counseling|"Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling.
~Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit."
15905962|NCT03603353|Other|Smoking cessation counseling|Participants in the control group will receive smoking cessation counseling only. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit.
15905963|NCT03603340|Other|ENDS (vaporizer/e-cig) and smoking cessation counseling|Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit.
15905964|NCT03603340|Other|Smoking cessation counseling|Participants in the control group will receive smoking cessation counseling only. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 24-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6, 12 and 24 months, participants will be asked to come to a clinical visit.
15905965|NCT03603327|Drug|Direct acting anti-viral agents|Standard of care for Hepatitis C treatment
15905966|NCT03603314|Drug|SENS-401|29 mg dose group: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks
15905967|NCT03603314|Other|Placebo Oral Tablet|placebo, oral route, by mouth, twice a day, during 4 weeks
15905968|NCT03603314|Drug|SENS-401|43.5 mg dose groupe: tablets of 14.5 mg, oral route, by mouth, twice a day, during 4 weeks
15905969|NCT03603288|Drug|idebenone 150 mg film-coated tablets|900 mg idebenone/day
15905970|NCT03603275|Drug|New FVIII products|Kovaltry or Jivi prescribed by the treating Physician
15905971|NCT03603262|Drug|SH-1028|Starting dose 60mg,oral administered once daily.If tolerated subsequent cohorts will test increasing doses (100mg,200mg,300mg,400mg) of SH-1028.
15905972|NCT03603249|Drug|Trimetazidine|Trimetazidine is a clinically effective antianginal agent that has no negative inotropic or vasodilator properties (6). It is presently clinically used throughout Europe and in >80 countries worldwide. It is a cytoprotective drug that normalizes metabolic disturbances in low-flow ischemia via several-not yet fully understood-mechanisms of action (7). The best-known mechanism of action is its capacity to inhibit β-oxidation of free fatty acid (FFA) (7).
15905973|NCT03603236|Diagnostic Test|preeclampsia|liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine
15905974|NCT03603236|Diagnostic Test|control|liver function tests, kidney function tests and platelets measures the ratio of protein to creatinine
15905975|NCT03603223|Biological|Pembrolizumab|Given IV
15905976|NCT03603210|Device|Drug coated balloon angioplasty|Drug coated balloons are semi compliant percutaneous coronary angioplasty balloons coated with a chemotherapeutic drug such as Paclitaxel used with an excipient which allows rapid absorption to vessel wall upon balloon expansion for 30-60s. This allows coronary angioplasty without any permanent or semi- permanent stent or scaffold provided there are no vessel threatening dissections or significant acute recoil.
15905977|NCT03603197|Drug|BP-C1|BP-C1, 0.05% solution for injection; doses: 0.035 mg/kg body weight (0.07 mL/kg) intramuscularly once daily for 32 consecutive days
15905978|NCT03603197|Drug|Placebo|Placebo, solution for injection; doses: 0.07 mL/kg body weight intramuscularly once daily for 32 consecutive days
15905979|NCT03603184|Drug|Atezolizumab|Atezolizumab will be administered as I.V. infusion at a fixed dose of 1200 mg, every 21 days until objective radiological disease progression as assessed by the investigator if they do not meet any other discontinuation criteria (patient refusal, toxicity).
15905980|NCT03603184|Drug|Placebos|Placebo will be administered as I.V. infusion every 21 days until objective radiological disease progression as assessed by the investigator if they do not meet any other discontinuation criteria (patient refusal, toxicity).
15905981|NCT03603184|Drug|Paclitaxel|Paclitaxel 175 mg/m2 will be administered every 21 days for 6-8 cycles or until progression of disease.
15905982|NCT03603184|Drug|Carboplatin|Carboplatin AUC 5 or AUC 6 will be administered every 21 days for 6-8 cycles or until progression of disease.
15905983|NCT03603171|Diagnostic Test|DM1-ActivC|A Rasch-built activity and participation scale for clinical use in myotonic dystrophy type 1 (DM1)
15905984|NCT03603171|Diagnostic Test|R-PAct|A Rasch-built Pompe-specific activity scale.
15905985|NCT03603171|Diagnostic Test|Beck depression inventory|A self-reported depression inventory administered verbally or self administered.
15905986|NCT03603171|Diagnostic Test|McGill pain questionnaire|The short form of the MPQ, used to evaluate the qualitative aspect of pain and categorized in three dimensions of pain experience: sensory qualities, affective qualities and overall intensity.
15905987|NCT03603171|Diagnostic Test|Brief Pain Inventory Short-Form|A 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning
15905988|NCT03603171|Diagnostic Test|Fatigue and Daytime Sleepiness Scale|A Rasch-built combined fatigue and daytime sleepiness scale (FDSS) specifically designed for patients with DM1.
15905989|NCT03603171|Diagnostic Test|Myotonia Behaviour scale|It consists of six framed sentences, which most closely describe the impact of the stiffness on everyday life
15905990|NCT03603171|Diagnostic Test|Hand opening time|A simple test to evaluate clinical myotonia: the patient makes a tight fist for 5 seconds, then rapidly open them and the opening time is measured.
15905992|NCT03603171|Diagnostic Test|Manual muscle testing|The patient is instructed to hold the corresponding limb or appropriate body part to be tested at the end of its available range while the practitioner provides opposing manual resistance. The strength is measured by the modified-MRC scale. The average value of two mesurements is considered. The following muscles were assessed: neck flexors and extensors, hip flexors and extensors, knee flexors and extensors, shoulder abductors, elbow flexors and extensors, ankle dorsiflexors and plantar flexors, wrist flexors and Extensors, digit flexors and extensors and thumb abductors.
15905993|NCT03603171|Diagnostic Test|Quantitative muscle testing|Strength testing using sophisticated strength measuring devices during an isometric contraction. The average value of two measurements is considered; in case of difference > 10% between measurements, a third attempt is performed. The following muscles are assessed: neck flexors and extensors, hip flexors and extensors, knee flexors and extensors, shoulder abductors, elbow flexors and extensors, ankle dorsiflexors and plantar flexors, wrist flexors and extensors and digit flexors.
15905994|NCT03603171|Diagnostic Test|Scale for Assessment and Rating of Ataxia|SARA is a clinical scale which assesses a range of different impairments in cerebellar ataxia.
15905995|NCT03603171|Diagnostic Test|Berg balance scale|It is a 14 item objective measure designed to assess static balance and fall risk in adult populations
15905996|NCT03603171|Diagnostic Test|Quick motor function test|Assessment of proximal motor function.
15905997|NCT03603171|Diagnostic Test|GSGC|GSGC score provides a detailed picture of motor function by including quantitative measures of four main motor performances (Gait, Walking, Stair, Gower's) and a qualitative global assessment of the manner to accomplish them.
15905998|NCT03603171|Diagnostic Test|30 seconds sit to stand test|It is a measurement that assesses functional lower extremity strenght in older adults.
15905999|NCT03603171|Diagnostic Test|Functional Index-2|Disease-specific functional outcome assessing muscle endurance. In this trial, only the part of the test for the upper extremities is used.
15906000|NCT03603171|Diagnostic Test|Six minute walking test|It is a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
15906001|NCT03603171|Diagnostic Test|Myotonia (from Individualised Neuromuscular Quality of Life Questionnaire)|A subscale derived from the Individualised Neuromuscular Quality of Life Questionnaire (INQoL). 3 questions reguarding stiffness/myotonia.
15906002|NCT03603145|Procedure|Immediate insertion|Immediate insertion of intrauterine contraception within 48 hours of medical abortion
15906003|NCT03603132|Drug|Hetrombopag Olamine|7.5mg in each cycle
15906004|NCT03603119|Drug|Normal saline, Midazolam|2 cc normal saline i.v. after anaesthesia induction.2 mg of injection midazolam intravenous 30 minutes prior to the end of surgery
15906005|NCT03603119|Drug|Dexamethasone, ondansetron|8mg of dexamethasone i.v. after anaesthesia induction and 4 mg of ondansetron i.v. 30 minutes prior to the end of surgery.
15906006|NCT03603106|Drug|P03277|"Part I: P03277 was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.
~Part II: P03277 was administered intravenously with a flow rate of 2 mL/s."
15906007|NCT03603106|Drug|Placebo|"Part I: Placebo was administered intravenously with a flow rate ranging from 0.5 to 2 mL/s.
~Part II: Placebo was administered intravenously with a flow rate of 2 mL/s."
15906008|NCT03603080|Drug|Administration of weight loss drug (Metformin or Topiramate)|Patients in this arm will receive either Metformin (500 mg, twice per day) or Topiramate (50 mg, once per day) starting at 4 weeks after laparoscopic sleeve gastrectomy
15906009|NCT03603067|Procedure|Ocular surgery|Different ocular surgeries (including vitreoretinal surgery, cataract surgery, anti-glaucoma surgery etc) will be performed in one eye of the patient. In monophthalmic patient group the surgery will be performed in eye with better visual acuity.
15906010|NCT03603054|Other|Active neck mobilization|The subjects, receive an active neck mobilization intervention.
15906011|NCT03603054|Other|Active Mobilization of the sciatic nerve|The subjects, receive an active sciatic nerve mobilization intervention.
15906012|NCT03603041|Dietary Supplement|Whey protein|Participants in the protein arms will receive whey protein daily for 16 weeks.
15906013|NCT03603041|Dietary Supplement|Omega-3 fatty acids|Participants in the omega-3 fatty acid arms will receive capsules daily for 16 weeks.
15906014|NCT03603028|Device|Exergaming|Mixed Reality Gaming for Chronic Low Back Pain
15906015|NCT03603015|Diagnostic Test|Penile cuff test|Comparison of invasive vs non-invasive urodynamics
15906016|NCT03603002|Diagnostic Test|Post-SABR Biopsy|Post-SABR Biopsy
15906017|NCT03602989|Device|AI-enabled Diabetic Retinopathy Screening Software|Color fundus images of both eyes are captured on site before being uploaded to and analyzed by the cloud-based Artificial Intelligence software
15906018|NCT03602976|Drug|Ursodeoxycholic Acid|weight-based dosing
15906019|NCT03602963|Device|Dexcom G5 Mobile CGM system|The accuracy and usability ot the Dexcom G5 mobile CGM system will be evaluated
15906020|NCT03602950|Biological|PRP|autologous PRP will be injected subcutaneously before skin closure at time of elective CS
15906021|NCT03602937|Dietary Supplement|Renastep|Renastep is a ready-to-use, high energy, low volume liquid renal specific feed that can be administered enterally via tube or oral consumption.
15906022|NCT03602911|Drug|The isotope 68Ga, NETSPOT and 18F-FDG-PET/CT|All patients will undergo 18F-FDG-PET/CT per established protocol. Following 18F-FDG-PET/CT, the patient will undergo NETSPOT imaging
15906023|NCT03602898|Biological|Anti-Thymocyte Globulin|Given IV
15906024|NCT03602898|Drug|Busulfan|Given IV or PO
15906025|NCT03602898|Drug|Cyclophosphamide|Given IV
15906026|NCT03602898|Drug|Cyclosporine|Given IV or PO
15906027|NCT03602898|Drug|Fludarabine Phosphate|Given IV
15906028|NCT03602898|Drug|Methotrexate|Given IV
15906029|NCT03602898|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo peripheral blood stem cell transplantation
15906030|NCT03602898|Other|Quality-of-Life Assessment|Ancillary studies
15906031|NCT03602898|Other|Questionnaire Administration|Ancillary studies
15906032|NCT03602898|Drug|Tacrolimus|Given IV or PO
15906033|NCT03602898|Radiation|Total-Body Irradiation|Undergo TBI
15906034|NCT03602885|Behavioral|Usual chemotherapy education (CE)|Standard chemo education will given per hospital guideline
15906234|NCT03601429|Dietary Supplement|Placebo|capsules
15906037|NCT03602859|Drug|Niraparib|Participants in each arm will receive oral capsules of niraparib as a unit dosage strength of 100 milligrams (mg).
15906038|NCT03602859|Drug|Dostarlimab (TSR-042)|Participants will receive 30 minutes intravenous (IV) infusions of 1000 mg dostarlimab on Day 1 every 6 weeks.
15906039|NCT03602859|Drug|Placebo|Capsule with no active drug to mimic Niraparib, or IV fluid with no active drug to mimic Dostarlimab (TSR-042)
15906040|NCT03602859|Drug|Standard of care|Participants will receive SOC that includes paclitaxel 175 milligrams per square meter (mg/m^2) on day 1 every 21 days + area under the curve (AUC) of 5 to 6 milligrams per milliliter per minute (mg/mL/min) on day 1 every 21 days + bevacizumab 7.5 milligrams per kilograms (mg/kg) every 21 days or 15 mg/kg every 21 days for a total of 15 months.
15906041|NCT03602859|Drug|Dostarlimab/Placebo|Participants will receive 1000 mg of dostarlimab/placebo on day 1 every 6 weeks to continue up to 3 years in the absence of disease progression, unacceptable toxicity, patient withdrawal, or investigator decision
15906042|NCT03602859|Drug|Niraparib/Placebo|Participants in each arm will receive oral capsules of niraparib/placebo as a unit dosage strength of 100 mg.
15906043|NCT03602846|Dietary Supplement|Medical Nutrition Therapy|Only given medical nutrition therapy.
15906044|NCT03602846|Drug|Insulin|Prescribed with rapid acting, intermediate acting, mixed or long acting insulin.
15906045|NCT03602846|Drug|Oral Antidiabetics|Prescribed with all types of oral anti-diabetics.
15906046|NCT03602833|Drug|Compound 451238|Each patient will receive compound 451238 until disease progression unacceptable toxicities.
15906047|NCT03602820|Biological|AAV2-hRPE65v2|
15906048|NCT03602807|Device|Extracorporeal Shockwave Therapy|"2 treatments a week for 3 weeks consisting of 3000 focused shockwaves of 4Hz and 0,20mJ/mm2 applied over the kidney allograft.
~Treatment is performed using the STORZ DUOLITH® SD1 T-TOP F-SW ultra"
15906049|NCT03602794|Procedure|PECs Block|Regional Anaesthesia Technique ie Pectoralis Nerve Block under ultrasound guidance
15906050|NCT03602794|Procedure|Local infiltration|LIA will be performed by surgeon during the operation. The upper skin flap will be raised in the standard manner for mastectomy. The lateral border of the major pectoralis muscle will then be visualised. A volume of 10 ml ropivacaine 0.5% will be delivered between the inter-fascial planes of the pectoral muscles. The lower skin flap will then be raised in the standard manner for mastectomy and the breast is raised off the pectoralis muscle exposing the serratus anterior muscle. A volume of 20 ml ropivacaine 0.5% will be delivered between the muscle planes of the serratus anterior and pectoralis minor muscles.
15906051|NCT03602781|Drug|Placebo|Placebo at a dose setting of 75 mcg/kg IBW/hr
15906052|NCT03602781|Drug|iNO|iNO at a dose setting of 75 mcg/kg IBW/hr
15906053|NCT03602768|Behavioral|Goal Management Training|Pre-recorded videos and games combine psycho-education, targeted skills training, and mindfulness practice to teach a system where participants can take control of their attention and cognitive faculties.
15906054|NCT03602768|Behavioral|Memory & Aging Program|Pre-recorded videos and activities combine psycho-education, memory strategy training, and social support to educate about normal memory change in aging, normalize the experience of participants going through it, and equip them to handle age-related memory change.
15906055|NCT03602768|Behavioral|Cambridge Brain Sciences|Commercial brain training software available for subscription to the general public and for research studies.
15906056|NCT03602742|Device|EZYPRO®|Wear two devices including 24-hour Holter and 14-day continuous EZYPRO® to evaluate the performance
15906057|NCT03602729|Other|Breastfeeding education|Breastfeeding education in three different forms: written/verbal/video
15906058|NCT03602716|Device|HD-tDCS|HD-tDCS is going to be delivered at 1.5 mA intensity for 20 minutes once a day (+15 s fade-in and fade-out); sessions will be performed on 10 days 5 consecutive weekdays with sustained effects at T1 and T2. HD-tDCS will be used with the anode placed over the left DLPFC (F3) surrounded by four cathodes at F5, F1, FC3, and AF3 based on the 10/20 international EEG system.
15906059|NCT03602716|Device|Sham HD-tDCS|HD-tDCS is going to be used with the anode placed over the left DLPFC (F3) surrounded by four cathodes at F5, F1, FC3, and AF3 based on the 10/20 international EEG system; sessions will be performed on 10 days 5 consecutive weekdays with sustained effects at T1 and T2. This group will have a 20-min-sham stimulation.
15906060|NCT03602703|Diagnostic Test|Flow cytometry and Western Blot analysis|Diagnostic tests
15906061|NCT03602690|Drug|Dolutegravir + Darunavir/ritonavir + optimized NRTI|Dolutegravir 50mg once daily Darunavir/ritonavir 600/100 twice daily Optimized NRTI recycling with lamivudine and one other NRTI (zidovudine or tenofovir or abacavir)
15906062|NCT03602677|Device|ICG fluorescence imaging|The use of indocyanine green fluorescence imaging as an addition to standard surgical procedure.
15906063|NCT03602651|Other|Hamilton-anxiety scale (HAM-A)|Evolution of anxiety disorders is evaluated by the Hamilton-anxiety scale (HAM-A)
15906064|NCT03602638|Drug|Sitagliptin|Sitagliptin 100mg QD
15906065|NCT03602638|Drug|Acarbose|Acarbose
15906066|NCT03602612|Drug|Cyclophosphamide|300 mg/m^2 IV over 30 minutes on days -5, -4, and -3
15906067|NCT03602612|Drug|Fludarabine|30 mg/m^2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on day -5, -4, -3
15906068|NCT03602612|Biological|Anti-BCMA CAR T cells|0.75x10^6 - 12.0X10^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
15906069|NCT03602586|Drug|Epacadostat|Given PO
15906070|NCT03602586|Biological|Pembrolizumab|Given IV
15906071|NCT03602560|Drug|seladelpar 5-10 mg|Seladelpar 5 mg for 6 months and then titrating up to 10 mg based on tolerability and response for remainder of double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety study. Subjects will continue the seladelpar dose (5 or 10 mg) received during the double-blinded study
15906072|NCT03602560|Drug|seladelpar 10 mg|Seladelpar 10 mg for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label safety study. Subjects will continue the seladelpar dose (10 mg) received during the double-blinded study
15906073|NCT03602560|Drug|Placebo|One capsule daily for double-blind period. After completion of the 1-year double-blind period subjects will be offered the opportunity to enter an open label long term safety study. Subjects on placebo will be re-randomized to initiate seladelpar at 5 or 10 mg once daily
15935983|NCT03373201|Drug|Placebo|Oral capsule
15906074|NCT03602547|Drug|CM082 plus JS001|CM082：200mg once a day (qd) orally (taken within half an hour after breakfast). JS001 :An intravenous infusion of a solution having a concentration of 1-10 mg/ml was prepared with 0.9% physiological saline, and administered once every two weeks. Using an inline filter (0.2 or 0.22 μm), the drug was diluted with physiological saline and intravenously administered within 60 minutes.
15906075|NCT03602521|Other|Interpersonal stress|"Through an interview the evaluator will make a 1 to 2 pages script, written in first-person and in present tense. It will involve an interpersonal conflict between the participants and the person who once trigger their feeling of abandonment.
~After reading the script the participants will have to close their eyes and imagine the event as if was happening to them, now, in real time, and think about it during 3 minutes.
~To evaluate the stress efficiency, the evaluator will ask 2 questions :
~1) from 0 (no distress at all) to 10 (maximal unimaginable distress), to wich point this script bring distress to you?
~2) from 0 (I can not at all) to 10 (I can completely), to wich point are you able to imagine the scenario in real time, as if you were living it?"
15906076|NCT03602508|Drug|mirabegron|oral
15906077|NCT03602508|Drug|solifenacin|oral
15906078|NCT03602508|Drug|darifenacin|oral
15906079|NCT03602508|Drug|imidafenacin|oral
15906080|NCT03602508|Drug|tolterodine|oral
15906081|NCT03602508|Drug|oxybutynin|oral
15906082|NCT03602508|Drug|trospium|oral
15906083|NCT03602508|Drug|fesoterodine|oral
15906084|NCT03602508|Drug|propiverine|oral
15906085|NCT03602495|Drug|Donafenib|Donafenib 0.3g Bid orally, continuously. Dose interruptions or reductions were allowed for subjects who experienced treatment-related toxicity.
15906086|NCT03602495|Drug|Placebo|Matching placebo Bid orally, continuously.
15906087|NCT03602482|Behavioral|Standing|Participants will stand and complete cognitive tests.
15906088|NCT03602482|Behavioral|Supine|Participants will complete cognitive tests while supine.
15906089|NCT03602469|Drug|Bupivacaine|Ultrasound-guided suprascapular nerve block will be performed using 7 mL of 0.5% bupivacaine plus 3 mL of 0.9% saline
15906090|NCT03602469|Drug|Bupivacaine-magnesium|Ultrasound-guided suprascapular nerve block will be performed using 7 mL of 0.5% bupivacaine plus magnesium sulfate 10% (3 ml) (total 10mL)
15906091|NCT03602469|Drug|Propofol|Using propofol 1.5-2.5 mg/kg
15906092|NCT03602469|Device|Ultrasound|Ultrasound-guided suprascapular nerve block
15906093|NCT03602469|Drug|Sevoflurane|Sevoflurane 0.7-1.5 MAC in 40% oxygen
15906094|NCT03602469|Drug|Rocuronium|Rocuronium 0.6 mg/kg
15906095|NCT03602456|Other|Kentucky HEALTH|KY HEALTH is the modified Medicaid program including key components such as community engagement requirements, premiums and lockouts, redetermination lockouts, and the My Rewards incentive program.
15906096|NCT03602443|Behavioral|LSVT®BIG Intervention|Participants will complete LSVT®BIG intervention which consists of 16 one-hour sessions on 4 consecutive days for 4 weeks, and a home program component.
15906097|NCT03602443|Behavioral|Waitlist Control|Participants randomized to this arm will be followed for the 4-week time period. We will track engagement in any daily exercise (not therapy services) through self-report.
15906098|NCT03602430|Drug|Cholecalciferol|Native vitamin D dose of 200IU to be given once per month to hemodialysis patients
15906099|NCT03602430|Drug|Placebo|A Placebo ampule will be given to hemodialysis patients once per month with their standard treatment for 3 months period. Same color, odor and size, only without the active constituent.
15906100|NCT03602417|Device|Flare type stent|Flare type has a wide diameter at proximal portion to prevent stent migration.
15906101|NCT03602417|Device|Conventional D-type stent|This stent is an original full covered stent to treat malignant colorectal obstruction.
15906102|NCT03602391|Behavioral|SCP Plus|The primary goal of the proposed project is to develop an in-home psychoeducational intervention (Senior Companion Program Plus, or SCP Plus) that is accessible, affordable, and sustainable for low-income African American ADRD caregivers. A weekly, 60 minute psychoeducational module will be delivered face-to-face across 9 weeks and will focus on education about ADRD, behavior management, communication skills, and aspects of providing care that enhance meaning such as spirituality. In order to provide an accessible intervention that is potentially sustainable, Senior Companions will be trained to provide the intervention in the homes of the African American ADRD caregivers.
15906103|NCT03602378|Diagnostic Test|salivary cortisol|5 samples of saliva (first sample before around 22:00 and other samples the next morning, after awakening (00, 15, 30 and 60 minutes).
15906104|NCT03602378|Device|Holter Medilog AR12 Plus|Holter Medilog AR12 Plus - electrocardiogram during 5 minutes for measuring HRV
15906105|NCT03602378|Device|Polar V800|Polar V800 with sensor - during 5 minutes for measuring HRV
15906106|NCT03602378|Device|AGE reader|for measuring Advanced Glycation End products (AGEs)
15906107|NCT03602365|Device|Gentle Jogger (GJ)|Gentle jogger is a passive jogging device which passively moves the feet up and down simulating jogging
15906108|NCT03602339|Drug|Gadoterate (Dotarem/Clariscan)|Patients received a single dose of 0.5 molar gadoterate (0.1 mmol per kg body weight) intravenously.
15906109|NCT03602339|Drug|Gadobutrol (Gadavist/Gadovist, BAY86-4875)|Patients received a single dose of 1.0 molar BAY86-4875 (0.075 mmol per kg body weight) intravenously.
15906110|NCT03602326|Other|Neurodevelopmental Therapy-Bobath group|Neurodevelopmental Therapy-Bobath (NDT-B) is one of the most commonly used models for therapeutic management and treatment in patients with stroke. The basic philosophy underlying this approach is that; lesions in the central nervous system cause impairments in the coordination of movement and posture combined with problems in muscle tone which lead directly to functional limitations. According to the NDT-B approach, practice has a great role in treatment due to the fact that more practice leads to better motor learning and increases neural plasticity. According to NDT-B, the duration of treatment should not be limited to rehabilitation sessions, but should be designed to be implied throughout the day and should be adapted to the patients' daily life.
15906111|NCT03602326|Other|Standart Rehabilitation Group (SR group)|Standard Rehabilitation for Stroke consists of the hospitals' physiotherapy and rehabilitation routine.
15906112|NCT03602313|Device|Body Weight Support Gait Training|
15906113|NCT03602313|Other|Traditional Gait Training|
15906429|NCT03599843|Behavioral|Exercise|Participants will complete a 12 week exercise session that will be comprised of aerobic and/or resistance and/or flexibility training.
15906114|NCT03602300|Drug|Ravidasvir test formulation produced by Doppel|"To compare the rate and extent of absorption for RDV when administered as a single 200 mg oral dose of the proposed commercial product (test) produced by Doppel Farmaceutici with the clinical trial product (reference) manufactured by EEPI in healthy volunteers, under fasted conditions."
15906115|NCT03602300|Drug|Ravidasvir reference formulation produced by EEPI|"To compare the rate and extent of absorption for RDV when administered as a single 200 mg oral dose of the proposed commercial product (test) produced by Doppel Farmaceutici with the clinical trial product (reference) manufactured by EEPI in healthy volunteers, under fasted conditions."
15906116|NCT03602287|Drug|Lignocaine 2% Injection 20Ml Vial (Product)|2.5 ml of 2% of lignocaine is diluted with 2.5 ml of distilled water, and the 5ml solution will be injected into the Merocel pack 15 minutes before removal of the pack
15906117|NCT03602287|Drug|Normal saline|5 ml of normal saline was injected into the Merocel pack 15 minutes before removal of the pack
15906118|NCT03602274|Diagnostic Test|Hepatic function monitoring|AST, ALT, GGT, AP, Bilirubin
15906119|NCT03602274|Diagnostic Test|Nutritional status assesment|PINI, MNA nutritional assessment, PG-SGA assessment, anthropometric measurements
15906120|NCT03602274|Other|Biomarker research sampling|Blood collection for proteomic, genetic, metabolomic and microRNA transcriptomic profiling
15906121|NCT03602261|Drug|Calcifediol Oral Capsule|Capsule, weekly
15906122|NCT03602261|Drug|Placebo oral capsule|Capsule, weekly
15906123|NCT03602248|Other|Speed endurance training protocol A|1 set of 8 repetitions interspersed by 2,5 minutes of recovery with a work to rest ratio of 1:5 (25-30 seconds all out work)
15906124|NCT03602248|Other|Speed endurance training protocol B|1 set of 8 repetitions interspersed by 4 minutes of recovery with a work to rest ratio of 1:8 (25-30 seconds all out work)
15906125|NCT03602235|Other|Ascorbate|Ascorbate is in the vitamin drug class
15906126|NCT03602235|Drug|Melphalan|Melphalan is an alkylating agent coupled to an amino acid
15906127|NCT03602222|Behavioral|Mobile web training LGBT mental health|Mobile web training LGBT mental health: Half of the participants were randomly assigned to receive the training in LGBT mental health in a the mobile fashion (on the web).
15906128|NCT03602222|Behavioral|In-person training LGBT mental health|In-person training LGBT mental health: Half of the participants were randomly assigned to receive the training in LGBT mental health in-person.
15906129|NCT03602209|Procedure|Removal of infected implant|
15906130|NCT03602209|Drug|Antibiotic durations|
15906131|NCT03602196|Other|Perineal ultrasound assessment|"women were assessed in lithotomy position with an empty bladder at rest, perineal contraction and Valsalva maneuver using a linear translabial probe. We measure the distance between symphysis and ano-rectal angle. In the same position we investigate the levator ani viscoelastic properties using shear wave elastography at rest, Valsalva maneuver and maximal contraction. During the same examination, we assess the viscoelastic properties of the external anal sphincter using shear wave elastography for the 3 conditions: rest, Valsalva, contraction.
~This pelvic floor muscles assessment is performed for each of the three planned visits
~For the ancillary study on non pregnant women: viscoelastic properties of levator ani are assessed at rest, stretch and contraction using shear wave elastography.
~This pelvic floor muscle assessment is performed for each of the two planned visit in the ancillary study."
15906132|NCT03602196|Other|Peripheral muscles assessment|"The visco elastic properties of the biceps brachii muscle and the gastrocnemius medialis muscle are assessed rest, stretch and maximal contraction using shear wave elastography.
~This peripheral muscle assessment is perform for each of the three planned visits.
~For the ancillary study on non pregnant women: viscoelastic properties of biceps brachii and gastrocnemius medialis muscles are assessed at rest, stretch and contraction using shear wave elastography.
~This peripheral muscles ultrasound assessment is performed for each of the two planned visit in the ancillary study."
15906133|NCT03602196|Other|Clinical pelvic floor assessment|"Women undergo a pelvic floor assessment using the Pelvic organ prolapse quantification system. Such an assessment is performed for each of the three planned visits.
~Women included in the ancillary study are not involved with this examination"
15906134|NCT03602183|Device|Macintosh laryngoscope|intubation will be performed using standard direct laryngoscopy - Macintosh laryngoscope
15906135|NCT03602183|Device|Miller laryngoscope|intubation will be performed using Miller laryngoscope
15906136|NCT03602183|Device|McGrath MAC EMS|intubation will be performed using McGrath MAC EMS video - laryngoscope
15906137|NCT03602183|Device|GlideScope|intubation will be performed using GlideScope video - laryngoscope
15906138|NCT03602170|Behavioral|High-Intensity Interval Training|Supervised exercise sessions will be performed on a upright cycle ergometer. Training sessions involve 20 minutes of exercise by completing 10 repetitions of 60 seconds of exercise at 90-95% maximal heart rate with 60 seconds of active rest between each repetition at 50-60% maximal heart rate.
15906139|NCT03602170|Behavioral|Moderate-Intensity Continuous Training|Supervised exercise sessions will be performed on a upright cycle ergometer. Training sessions involve 30 minutes of continuous exercise at 65-70% maximal heart rate.
15906140|NCT03602157|Biological|ATLCAR.CD30.CCR4 cells|Three dose levels are being evaluated: 2x10^7, 5x10^7, 1x10^8
15906141|NCT03602157|Biological|ALTCAR.CD30 cells|Fixed dose level of 1x10^8
15906142|NCT03602157|Drug|Bendamustine|70 mg/m^2/day Bendamustine for 3 days for lymphodepletion prior to cell infusion
15906143|NCT03602157|Drug|Fludarabine|30 mg/m^2/day Fludarabine for 3 days for lymphodepletion prior to cell infusion
15906144|NCT03602144|Other|Carbohydrate|Participants will receive a carbohydrate-based breakfast beverage everyone morning for 42 days.
15906145|NCT03602144|Other|Protein|Participants will receive a protein-based breakfast beverage everyone morning for 42 days.
15906146|NCT03602131|Drug|Chidamide|30 mg oral twice weekly for 2 weeks
15906147|NCT03602131|Drug|Cladribine|6 mg/m2 intravenously once daily for 5 days
15906148|NCT03602131|Drug|gemcitabine|2500 mg/m2 intravenously twice weekly for 1 week
15906149|NCT03602131|Drug|Busulfan|3.2 mg/kg intravenously once daily for 4 days
15906150|NCT03602131|Procedure|Autologous hematopoietic stem cell transplantation|autologous hematopoietic stem cells infusion after ChiCGB chemotherapy
15906151|NCT03602118|Drug|Phenobarbital Sodium Injection|Phenobarbitone Inj, Phenobarbitone SOD, Phenobarbitone Sodium
15906152|NCT03602105|Behavioral|Exercise|Exercises in group and/or individually
15906153|NCT03602092|Other|Observation|This is a longitudinal, multi-center, registry study, collecting data via a web-based portal in patients with GIST (Gastrointestinal Stromal Tumor) from hospitals in Taiwan.
15906154|NCT03602079|Drug|A166|A166 is an Antibody Drug Conjugate (ADC) targeting HER2 expressing cancer cells.
15906155|NCT03602066|Drug|Chlorine Dioxide Sterilization|Given via oral rinse
15906156|NCT03602066|Other|Laboratory Biomarker Analysis|Correlative studies
15906157|NCT03602066|Other|Placebo|Given via oral rinse
15906158|NCT03602053|Biological|ROTAVAC®|0.5 ml of the vaccine will be administered orally thrice at 6, 10 and 14 weeks of age.
15906159|NCT03602053|Biological|ROTAVAC 5D|0.5 ml of the vaccine will be administered orally thrice at 6, 10 and 14 weeks of age.
15906160|NCT03602053|Biological|Rotarix®|1.5 ml of the liquid vaccine will be administered orally twice at 6 and 10 weeks of age.
15906161|NCT03602040|Behavioral|PISICC|"PISICC consists of:
~Standard disease-specific information leaflet
~Personalised lifestyle consideration form
~1-hour group session with up to 10 participants facilitated by the PhD student who is also an experienced cardiac genetic nurse. This will include discussions of 2 scenarios (communicating with clinicians and communicating with family) and a question and answer session based on the personalised lifestyle consideration form Components a) and b) will be given to the patient after the baseline assessment and there will be an interval of 2 weeks before the participants attend for component c)."
15906162|NCT03602027|Drug|Anlotinib|Anlotinib 8mg p.o. qd in low-dose groups (3 subjects). 10mg p.o. qd in middle-dose groups (3 subjects). 12mg p.o. qd in high-dose groups (3 subjects).
15906163|NCT03602027|Drug|Gefitinib|Gefitinib 250mg orally daily for three weeks
15906164|NCT03602014|Drug|Northera|Study 1 is a dose optimization, open-label trial of Northera from a dose range of 200mg up to 800mg.
15906165|NCT03602014|Other|Placebo|Study 2 is blinded placebo controlled trial using the individualized optimal dose of droxidopa determined by study 1.
15906166|NCT03602001|Behavioral|Attentive eating smartphone application.|A smartphone application that encourages a more attentive eating style.
15906167|NCT03602001|Behavioral|Standard dietary advice and text tips.|Standard dietary advice for weight loss booklet and weekly text tips containing dietary advice.
15906168|NCT03601988|Radiation|Concurrent chemo-radiotherapy|Experimental group receive 6 cycles of XELOX chemotherapy and concurrent chemo-radiotherapy. The radiotherapy dose of 45Gy in 25 fractions delivered by IMRT Radiotherapy
15906169|NCT03601988|Drug|Chemotherapy|Chemotherapy group receive 8 cycles of XELOX.
15906170|NCT03601975|Drug|Gemcitabine/Cisplatin|gemcitabine (1000 mg/m² d1,8) or cisplatin (80mg/m² d1) every 3 weeks for every cycle
15906171|NCT03601962|Dietary Supplement|Aqualief|400mg oral mucoadesive tablets
15906172|NCT03601962|Other|Placebo|400mg Placebo oral mucoadesive tablets
15906173|NCT03601949|Device|SInergy Cooled Radiofrequency|ablation of low back pain
15906174|NCT03601949|Other|Medical Management|physical therapy, medications, lifestyle changes
15906175|NCT03601936|Device|Evivo Infant Gut Bifidobacterium Screening Test|Operators at each test site will collect and test infant stool specimens according to the Evivo Infant Gut Bifidobacterium Screening Test protocol.
15906176|NCT03601923|Drug|Niraparib|"Niraparib belongs to a class of anti-cancer agents known as PARP (poly ADP ribose polymerase) inhibitors. PARP is a protein in the body that repairs damage to DNA (one of the building blocks of a cell). In cells that are rapidly growing, such as cancer cells, blocking repair of DNA may be of benefit, since it will cause the cell to die.
~Niraparib will be given at an initial dose of 200mg or 300 mg by mouth once daily depending on the patient's platelet count and weight at the start of the trial."
15906177|NCT03601910|Drug|D308 10mg Tab.|D308 10mg Tab.1T single oral administration under fasting condition
15906178|NCT03601910|Drug|CKD-380 10mg Tab.|CKD-380(Dapagliflozin) 10mg Tab.1T single oral administration under fasting condition
15906179|NCT03601897|Drug|rebastinib|25 mg tablets or 75 mg tablets
15906180|NCT03601897|Drug|Paclitaxel|Paclitaxel administered by IV infusion at 80 mg/m2
15906181|NCT03601884|Behavioral|Optimal Health Program|The Optimal Health Program (OHP) is a self-management psychosocial program that promotes patients to be actively involved in their own healthcare and overall well-being. Sessions include Optimal Health, I-CAN-DO Model, Medication & Metabolic Monitoring, Collaborative & Strategies, Change enhancement, Visioning & Goal Setting and Maintain Well-being.
15906182|NCT03601884|Other|Treatment as Usual|"Treatment-as-usual TAU is the pharmacological treatment received or prescribed by the patients' attending doctor.
~To ensure standardization of treatment, attending doctors will be reminded to manage patients in accordance with the Clinical practice Guideline in Managing Diabetes Melllitus in adult patients."
15906183|NCT03601871|Drug|Thalidomide|Thalidomide (Thalidomide Oral Product)100 mg by mouth twice a day on days 1-5 after chemotherapy .
15906184|NCT03601871|Drug|Dexamethasone|Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4
15906185|NCT03601871|Drug|5-HT3 antagonists|Palonosetron 0.25 mg intravenously on day 1; or 1st-generation 5-HT3 antagonists (used as clinal routine) on day 1-3
15906186|NCT03601845|Other|Stimuli|Visual stimulation while using additional sequencing
15906187|NCT03601845|Other|No stimuli|Additional sequencing only
15906188|NCT03601832|Procedure|4-D navigated stereotactic radiosurgical ablation|4-D Navigated Non-invasive radiosurgical ablation of ventricular tachycardia in patients with sustained monomorphic ventricular tachycardia/tachycardias after myocardial infarction.
15906189|NCT03601819|Drug|Pacritinib|Patients will receive continuous treatment until progressive disease, toxicity, or until any other condition for treatment discontinuation has been met.
15906190|NCT03601806|Other|Laboratory Biomarker Analysis|Correlative studies
15906191|NCT03601806|Drug|Pomalidomide|Given PO
15906192|NCT03601793|Behavioral|Alcohol Help Center|An internet intervention based on CBT consisting of about 20 modules aimed at helping people with drinking problems
15906193|NCT03601793|Behavioral|Assistance from a health educator|This entails email contact with a health educator that guides the participant through the Alcohol Help Center during the first two weeks
15906194|NCT03601780|Drug|local wound infiltration plus usual care|local wound infiltration plus usual care
15906195|NCT03601780|Drug|usual care only|usual care only
15906554|NCT03598790|Drug|Bimekizumab|Subjects will receive bimekizumab at pre-specified time-points.
15906196|NCT03601754|Diagnostic Test|Treadmill/Bicycle exercise testing|"Exercise testing will be scheduled on the same day as the enrollment visit and within 30 days after post-implant visit.
~The standard protocol will be typically set at an initial workload of 15Watts and go up by increments of 10 Watts every 3 minutes, as follows:
~Stage 1 - 15 W Stage 2 - 25 W Stage 3 - 35 W Stage 4 - 45 W"
15906197|NCT03601741|Other|Daily Antimicrobial Stethoscope Diaphragm Cover|Patients will receive package with instructions to use stethoscope cover, and are then instructed to switch in 7 days
15906198|NCT03601741|Other|Uncovered Stethoscopes|Patients receive instruction to begin with no covers, and are then instructed to switch in 7 days
15906199|NCT03601728|Behavioral|personalized prehabilitation|The 60-minute education session includes a 30-minute general education on exercise in older adults and a 30-minute instruction on participating in the study intervention (how to work with the personalized circadian-based activity guideline). The education session will be developed and presented by the PI and the certified exercise trainer. The general education session will be designed using materials from Go4Life program from the National Institute on Aging (https://go4life.nia.nig.gov). The personalized circadian-based activity guideline (exercise goal and plan) will be developed by the investigators and the exercise trainer based on the individual's typical daily circadian profile, functional status, preference for exercise.
15906200|NCT03601715|Other|Coplanar|The coplanar arrangement will be applicated in each one of the subjects. The intervention will last 20 minutes. A towel will be placed between the pad electrode and the skin to improve contact, besides, the tight and the electrode will be wrapped with an elastic band for the same purpose. The subject will receive orientation related to the heat intensity, it must be a comfortable perception of heat (the intensity will be regulated on the equipment to guarantee that).
15906201|NCT03601715|Other|Contraplanar|The contraplanar arrangement will be applicated in each one of the subjects. The intervention will last 20 minutes. A towel will be placed between the pad electrode and the skin to improve contact, besides, the tight and the electrode will be wrapped with an elastic band for the same purpose. The subject will receive orientation related to the heat intensity, it must be a comfortable perception of heat (the intensity will be regulated on the equipment to guarantee that).
15906202|NCT03601715|Other|Longitudinal|The longitudinal arrangement will be applicated in each one of the subjects. The intervention will last 20 minutes. A towel will be placed between the pad electrode and the skin to improve contact, besides, the tight and the electrode will be wrapped with an elastic band for the same purpose. The subject will receive orientation related to the heat intensity, it must be a comfortable perception of heat (the intensity will be regulated on the equipment to guarantee that).
15906203|NCT03601702|Device|Mechanical thrombectomy with EmboTrap ® II Device|Endovascular treatment with mechanical thrombectomy using EmboTrap ® II Device (Neuravi)
15906204|NCT03601689|Procedure|rectal resection|total mesorectal excision
15906205|NCT03601676|Other|Integration of electronic clinical decision support|Integration of an electronic clinical decision support system into the emergency department patient care workflow to assist with site-of-care decision-making for emergency department patients with acute pulmonary embolism.
15906206|NCT03601663|Behavioral|Physical Activity Information|Participants will receive a copy of the Canadian Physical Activity Guidelines.
15906207|NCT03601663|Behavioral|Physical Activity Monitoring|Participants will receive a wearable activity tracker (Polar A300).
15906208|NCT03601663|Behavioral|Autonomy-support|Participants will receive eight autonomy-supportive weekly emails containing information and activities to help them set goals and make changes to become physically active.
15906209|NCT03601650|Behavioral|Mindful eating|Attending to the sensory properties of food as it is eaten
15906210|NCT03601650|Behavioral|Eating without distractions|Eating without intentionally attending to something else such as a television, smartphone, computer, book etc
15906211|NCT03601637|Drug|LUM|Fixed Dose Combination (FDC) granule (LUM/IVA)
15906212|NCT03601637|Drug|IVA|FDC granule (LUM/IVA)
15906213|NCT03601624|Drug|Pomalidomide|"Pomalidomide at 4 mg orally on days 1-21 of a 28 day cycle
~Cyclophosphamide 300 mg IV on days 1 and 15 of a 28 day cycle.
~Dexamethasone 40 mg PO weekly.(Or 20 mg if patients are older than 75 years )"
15906214|NCT03601611|Drug|Tocilizumab (RoACTEMRA®)|Prednisolon will be given in case of worsening of symptoms
15906215|NCT03601598|Drug|SHR-1210|SHR-1210 was administered 200mg iv every 2 weeks
15906216|NCT03601598|Drug|SHR6390|SHR6390 was administered 150mg or 100mg oral daily with 3 weeks on and 1 week off
15906217|NCT03601585|Device|Comparison of dental biofilm removal.|Comparison of the use of 4 methods for dental biofilm removal
15906218|NCT03601572|Other|No intervention|No intervention
15906219|NCT03601559|Dietary Supplement|Lactobacillus paracasei Lpc-37|Live probiotic bacteria
15906220|NCT03601559|Dietary Supplement|Placebo|Inert placebo matched for taste and appearance
15906221|NCT03601546|Other|Clinical examination|Blood test and patient interview as for standard patient care
15906222|NCT03601533|Drug|Phenol|1,5 mL of 7% phenol will be injected in each of genicular nerves (superior, medial and lateral).
15906223|NCT03601507|Drug|Alpelisib|Given PO
15906224|NCT03601507|Other|Laboratory Biomarker Analysis|Correlative studies
15906225|NCT03601507|Other|Pharmacodynamic Study|Correlative studies
15906226|NCT03601507|Procedure|Therapeutic Conventional Surgery|Undergo surgery
15906227|NCT03601494|Other|perineural injection of platelet-rich plasma|Sonographic guided injection was done under complete sterile conditions including skin sterilization, ultrasound probe covered with sterile pad, and a sterile gel. The needle was introduced from the lateral side toward midline using the in-plane approach to target the desired nerve, each nerve was injected by a single dose of 1.5 cc of PRP. Free hand one-man technique was used by the physician who simultaneously managed the ultrasound device by holding the syringe with one hand while scanning the nerve by moving the probe with the other hand. With continuous imaging of the tip of the needle, the syringe was put around the nerve and platelet-rich plasma was injected in the peri-neural tissue.
15906228|NCT03601494|Drug|medical|vitamin B complex, α lipoic acid, selective serotonin reuptake inhibitor (SSRI)
15906229|NCT03601455|Biological|Durvalumab|Given IV
15906230|NCT03601455|Radiation|External Beam Radiation Therapy|Undergo EBRT
15906231|NCT03601455|Biological|Tremelimumab|Given IV
15906233|NCT03601429|Dietary Supplement|Lactogyn|capsules
15906235|NCT03601416|Drug|Transplantation of mesenchymal stem cell|"Human umbilical cord-derived mesenchymal stem cell will be given to participants through intravenous infusion.
~Dose A - 1 million cells per kg Dose B - 5 million cells per kg"
15906236|NCT03601416|Drug|No Transplantation of Mesenchymal Stem Cell|Human umbilical cord-derived mesenchymal stem cell will be not given to participants through intravenous infusion.
15906237|NCT03601403|Device|inhaler technique|The first day of the intervention consisted primarily of ventilatory re-education. During the realization of the technique, he was videotaped with a Tablet so that later the patient could be seen and on the video to be able to give him the guidelines for the correction. On the second and third day of the intervention, ventilation re-education was performed and the inhalation technique was subsequently trained.
15906238|NCT03601390|Device|PET/CT and EBV DNA|PET/CT and EBV DNA will be proformed after the IMRT treatment
15906239|NCT03601377|Behavioral|Training away from threat|Dot-probe task: Pairs of stimuli, angry - neutral face or neutral - neutral faces of the same actor (20 different individuals;10 male, 10 female) are presented horizontally in the centre of the screen (160 trials; 120 angry-neutral and 40 neutral-neutral). Each trial begins with a fixation cross (500 ms), on which the participants are instructed to focus their gaze. After that a pair of faces follows which is presented on the screen for 500ms. After the faces presentation a small visual probe (< or >) appears at the same place of one of the two faces. Participants have to determine which symbol appeared by clicking right or left on the mouse as quickly as possible. The target probe remains on the screen until there is a response, which starts a new trial.
15906240|NCT03601377|Behavioral|Training towards threat|Dot-probe task: Pairs of stimuli, angry - neutral face or neutral - neutral faces of the same actor (20 different individuals;10 male, 10 female) are presented horizontally in the centre of the screen (160 trials; 120 angry-neutral and 40 neutral-neutral). Each trial begins with a fixation cross (500 ms), on which the participants are instructed to focus their gaze. After that a pair of faces follows which is presented on the screen for 500ms. After the faces presentation a small visual probe (< or >) appears at the same place of one of the two faces. Participants have to determine which symbol appeared by clicking right or left on the mouse as quickly as possible. The target probe remains on the screen until there is a response, which starts a new trial.
15906241|NCT03601377|Behavioral|Placebo|Dot-probe task: Pairs of stimuli, angry - neutral face or neutral - neutral faces of the same actor (20 different individuals;10 male, 10 female) are presented horizontally in the centre of the screen (160 trials; 120 angry-neutral and 40 neutral-neutral). Each trial begins with a fixation cross (500 ms), on which the participants are instructed to focus their gaze. After that a pair of faces follows which is presented on the screen for 500ms. After the faces presentation a small visual probe (< or >) appears at the same place of one of the two faces. Participants have to determine which symbol appeared by clicking right or left on the mouse as quickly as possible. The target probe remains on the screen until there is a response, which starts a new trial.
15906242|NCT03601351|Other|ELISA for MOR-1 expression|To evaluate MOR-1 expression differences by immunohistochemical analysis (ELISA - semiquantitative) in paraffin samples from patients with colorectal cancer stage II / III submitted scheduled colorectal surgery between the tumor tissue and the adjacent nontumorous tissue.
15906243|NCT03601338|Drug|Bemiparin|second generation low molecular weight Heparin
15906244|NCT03601338|Other|multivitamins and routine antenatal follow up|multivitamins and routine antenatal follow up
15906245|NCT03601312|Behavioral|Exposure and Response Prevention|Exposure and response prevention is an evidence-based behavioral treatment that primarily focuses on exposures, in which the child faces OCD-related fears in a methodical manner and acquires more adaptive coping strategies.
15906246|NCT03601312|Behavioral|OC-Go|OC-Go is a HIPAA-compliant web-based clinician portal and patient-side mobile application that allows clinicians to create and push tailored treatment assignments to patients on their mobile devices. Individuals receiving this intervention will receive exposure and response prevention with OC-Go.
15906247|NCT03601299|Other|Traditional food|Increasing traditional food consumption through Head start programs in Alaska
15906248|NCT03601286|Drug|Lentiviral vector transduced CD34+ cells|Gene therapy for X-linked Severe Combined Immunodeficiency will be performed by introduction a normal copy of the IL2RG gene into the blood forming stem cells (CD34+ cells) of the patient's bone marrow by using a type of gene delivery system (in this trial called a lentiviral vector). The gene corrected cells are then transplanted back into the patient.
15906249|NCT03601273|Procedure|Left gastric artery embolization|"450-micron Embozene microparticles will be used intraarterially to occlude the left gastric artery and its branches.
~30-day post-embolization endoscopic biopsy"
15906250|NCT03601260|Drug|Allopurinol|Treatment of gout patients by oral dosage of 100 mg-300mg/ day of Allopurinol
15906251|NCT03601247|Device|silicone gel|"Patients who have consented to the study will receive two tubes labeled only left and right, corresponding to the side of the face to which the tube contents will be applied. One tube will contain silicone gel and the other tube will contain aquaphor. Neither the patient nor the surgeon will know what side will receive which treatment. These tubes will be given to patients at post-operative week 1 visit. Patients will be instructed to rub the solution into their eyelid incisions gently with their fingers for 2-3 minutes twice a day"
15906252|NCT03601234|Procedure|laparoscopic and endoscopic cooperative surgery|compare to the traditional surgery to resect the tumor,we will add the endoscopy during the operation to improve the safety and effectiveness of surgery
15906253|NCT03601234|Procedure|laparoscopic surgery|the traditional surgery
15906254|NCT03601221|Other|Sample collection|Collection of one sampling pouch from each blood donor
15906255|NCT03601208|Diagnostic Test|Mitra|When the patients have their bloods done through venepuncture, an additional 5-10mls will be taken (one EDTA bottle for tacrolimus and one serum bottle for creatinine; and two Mitra VAMs). Patients will also have a fingerprick test and 20 microlitres of blood taken using Mitra volumetric absorptive microsampling (VAMs)
15906256|NCT03601169|Dietary Supplement|Low Dose MMFS-205-SR|Twice daily, oral 500mg tablets
15906257|NCT03601169|Dietary Supplement|High Dose MMFS-205-SR|Twice daily, oral 500mg tablets
15906258|NCT03601169|Dietary Supplement|Placebo|Twice daily, oral
15906259|NCT03601156|Device|intraarterial chemoembolization|
15906260|NCT03601156|Device|intravenous chemotherapy|
15906261|NCT03601143|Other|Blood samples prior to a new line of AR-targeted therapy|Blood will be drawn at baseline prior to a new line of AR-targeted therapy.
15906262|NCT03601130|Device|HydroxyColl Bone Graft Substitute|The intervention involves the use of Open Wedge High Tibial Osteotomy with DePuy Synthes TomoFix Medial High Tibial Plate (MHT) fixation (Standard of Care) with the HydroxyColl bone graft substitute i.e. bone graft substitute vs. no bone graft substitute.
15906263|NCT03601130|Device|DePuy Synthes TomoFix Medial High Tibial Plate (MHT) fixation (Standard of Care)|The intervention involves the use of Open Wedge High Tibial Osteotomy with DePuy Synthes TomoFix Medial High Tibial Plate (MHT) fixation (Standard of Care) without the HydroxyColl bone graft substitute i.e. bone graft substitute vs. no bone graft substitute.
15906264|NCT03601117|Device|Dorsolateral Prefrontal Cortex Accelerated Theta Burst Stimulation|"Participants will receive iTBS (intermittent theta burst stimulation) to the left DLPFC.
~Stimulation intensity will be standardized at 80% of resting motor threshold (adjusted for cortical depth).
~Stimulation will be delivered using the Brainsway TMS system."
15906265|NCT03601117|Device|Anterior Cingulate Cortex Accelerated Theta Burst Stimulation|"Participants will receive iTBS (intermittent theta burst stimulation) to the anterior cingulate cortex (ACC).
~Stimulation intensity will be standardized at 80% of resting motor threshold (adjusted for cortical depth).
~Stimulation will be delivered using the Brainsway TMS system."
15906266|NCT03601104|Other|High intensity eccentric training|High intensity eccentric training group with 80% of isometric peak torque.
15906267|NCT03601104|Other|High intensity eccentric training with BFR|Eccentric high intensity training group with 80% of isometric peak torque associated with blood flow restriction (40% of absolute occlusion pressure).
15906268|NCT03601104|Other|Low intensity eccentric training with BFR|Low intensity eccentric training group with 40% of isometric peak torque associated with blood flow restriction (40% of absolute occlusion pressure).
15906269|NCT03601104|Other|Low intensity eccentric training|Low intensity eccentric training group with 40% of isometric peak torque
15906270|NCT03601091|Drug|Precedex 200 MCG in 2 ML Injection|Infusion therapy of the drug
15906271|NCT03601091|Drug|DORMICUM 5MG/5 ML|Infusion therapy of the drug
15906272|NCT03601078|Biological|bb2121|bb2121 consists of autologous T lymphocytes transduced with an anti-BCMA CAR lentiviral vector to express a chimeric antigen receptor targeting the human B cell maturation antigen (anti-BCMA CAR)
15906273|NCT03601065|Other|Videos of polyps, resection of polyps|Ther is no study specific intervention. Video sequences will be taken if polyps are found in the colon. Polyps will then be resected routinely.
15906274|NCT03601052|Drug|Remlarsen|Intradermal injection at site of one excisional wound
15906275|NCT03601052|Drug|Placebo|Intradermal injection at site of second excisional wound
15906276|NCT03601039|Device|Absnow Absorbable ASD Closure System|the eligible subjects who meet the inclusion criteria should sign the ICF before operation (-30 to 0 day), then receive the Absnow absorbable ASD Closure System implantation. The follow-up time will be set as observation point : the next day after operation, 30-day post-operative , 90-day post-operative, 180-day post-operative, 360-day post-operative, 2 year post-operative, 3 year post-operative, 4 year post-operative and 5 year post-operative. If any AE/SAE occurs during clinical trial, the subjects should be observed till such AE/SAE disappear or stable.
15906277|NCT03601026|Behavioral|Genetic counselling|Participants will receive information on risk/protective factors and causes of mental illness. Participants are not required to receive numeric/genetic risk information. Participants who choose to receive genetic and/or numeric risk information will be counselled on their risk of NOT developing and of developing SMI based on their genetic test results and/or family history information they provide. Risk estimates will be derived by genetic counsellors, according to standard practice guidelines. Participants who receive genetic information will be counselled on the possible influence of cannabis use on risk of mental illness based on their genotype. Participants who choose to not receive genetic information will be counselled on the influence of cannabis on mental health.
15906278|NCT03601013|Other|Demographical and Clinical Profile of Patients on Dual Antıplatelet Therapy|Demographical and Clinical Profile of Patients on Dual Antıplatelet Therapy
15906279|NCT03601000|Drug|Yi-Zhi-An-Shen|Yi-Zhi-An-Shen Granules 5g given three times a day for up to 16 weeks.
15906280|NCT03601000|Drug|Placebo|Placebo granules 5g given three times a day for up to 16 weeks.
15906281|NCT03600987|Behavioral|Simultaneous music and reading lyrics|listening to music with singing of the lyrics simultaneously with reading the written lyrics.
15906282|NCT03600987|Behavioral|Priming with music|priming by listening to music and singing of the lyrics followed by reading the written lyrics.
15906283|NCT03600987|Behavioral|Control|control condition using reading materials without music.
15906284|NCT03600974|Procedure|Stretta|Stretta for Endoscopy-E(+),Acid-A(+),Reflux-symptom association-S(+) or lower oesophageal sphincter-L(+) group
15906285|NCT03600974|Procedure|Laparoscopic Nissen fundoplication|Laparoscopic Nissen fundoplication for E(+),A(+) or L(+) group
15906286|NCT03600974|Drug|Probiotic Agent|Probiotic Agent for I(+)G/W；Live Bacillus Licheniformis Cranules 0.5g bid； Bifidbacterium 0.63g bid
15906287|NCT03600974|Drug|PPI|PPIs for A(+),E(+)or S(+) patients: Nexium 20mg Qd/Bid;Lansoprazole 30mg Qd/Bid；omeprazole 10mg-30mg Qd-Bid;Rabeprazole 10mg Qd/Bid;Esomeprazole 20mg Qd/Bid;Pantoprazole 40mg Qd/Bid
15906288|NCT03600974|Drug|Prokinetic Motility Agents|Prokinetic Motility Agents for M(+) group; Mosapride 5mg Tid; Domperidone 10mg Tid
15906289|NCT03600974|Drug|Neuromodulators|Neuromodulators for P(+) or S(+);Flupentixol and Melitracen 1# bid;
15906290|NCT03600961|Device|Orsiro Sirolimus Eluting Coronary Stent System|Percutaneous coronary intervention
15906291|NCT03600948|Device|Orsiro Sirolimus Eluting Coronary Stent System|Percutaneous coronary intervention
15906292|NCT03600935|Other|Vancouver Clinical Pathway|Vancouver Clinical Pathway
15906293|NCT03600922|Procedure|the patella was resurfaced.|Patellar resurfacing was undertaken using a cemented, inset domed component in TKA.
15906294|NCT03600909|Drug|Busulfan|"A standard dose of busulfan, associated with excellent outcomes in our previous trial will be used for young patients with marrow aplasia (arm A).
~A higher dose of busulfan will be used in younger patients with MDS and AML (arm B) to maximize disease control.
~A lower dose of busulfan will be used in older patients (arm C) to minimize toxicity."
15906295|NCT03600909|Drug|Fludarabine|Arms A, B and C - Fludarabine will be given IV over 30 minutes daily for 4 days. The dose will be adjusted according to renal function according to Institutional guidelines.
15936660|NCT03367923|Other|Counseling|Undergo exercise counseling
15906296|NCT03600909|Drug|Cyclophosphamide|Arms A, B and C - Cytoxan will be given as a 1-2 hour infusion for 4 days. The dose will be adjusted according to patients ideal body weight for obese patients.
15906297|NCT03600909|Drug|Anti-Thymocyte Globulin (Rabbit)|Arms A, B and C - 4 doses will be given prior to transplant to promote engraftment
15906298|NCT03600909|Device|The CliniMACS device|The source of stem cells for all patients will be peripheral blood stem cells (PBSC) induced and mobilized by treatment of the donor with G-CSF for 4-6 days. T-cell depletion will be uniformly performed by positive CD34 selection with the use of the Miltenyi system (CliniMACS device)
15906299|NCT03600909|Drug|G-CSF|All patients will also receive G-CSF post-transplant to foster engraftment.
15906300|NCT03600896|Drug|CYT107|"Phase I: Patients will be treated with CYT107 post CBT (from 60 to 180 days), in with 1 of 3 doses below:
~5 mcg/kg/dose for 3 doses
~10 mcg/kg/dose for 3 doses
~20 mcg/kg/dose for 3 doses
~The optimal recommended dose determined in Phase I will be used to treat all patient enrolled in Phase II."
15906304|NCT03600870|Drug|Midodrine|Midodrine is an oral alpha-1 agonist that increases vascular tone. It is administered orally. The initial starting dose will be midodrine 5mg orally three times a day. After 7-10 days, patients will increase the dose to 10mg three times a day as tolerated if no adverse effects occur. Treatment duration will be 6 months.
15906305|NCT03600857|Other|Home administration of misoprostol|First dose of misoprostol administration at home
15906306|NCT03600844|Behavioral|Community distribution of SP for IPTp|SP is distributed to eligible pregnant women by trained Community Health Workers (CHWs) at community level. Demand creation activities are implemented within the community as well.
15906307|NCT03600831|Drug|Docetaxel plus cisplatin|cisplatin 25mg/m2 on day 1 and docetaxel 25mg/m2 on day 1 weekly for 5 weeks
15906308|NCT03600831|Radiation|radiotherapy|radiotherapy: 50Gy (2.0 Gy/fraction, 5 days a week)
15906309|NCT03600818|Drug|Sarilumab SAR153191 (REGN88)|Pharmaceutical form:solution for injection Route of administration: subcutaneous
15906310|NCT03600818|Drug|Sarilumab-matching placebo|Pharmaceutical form:solution for injection Route of administration: subcutaneous
15906311|NCT03600818|Drug|Prednisone|Pharmaceutical form:over-encapsulated tablets Route of administration: oral administration
15906312|NCT03600818|Drug|Prednisone-matching placebo|Pharmaceutical form:over-encapsulated tablets Route of administration: oral administration
15906313|NCT03600818|Drug|Prednisone|Pharmaceutical form:tablets Route of administration: oral administration
15906314|NCT03600805|Drug|Sarilumab SAR153191|Pharmaceutical form:solution for injection Route of administration: subcutaneous
15906315|NCT03600805|Drug|Sarilumab matching placebo|Pharmaceutical form:solution for injection Route of administration: subcutaneous
15906316|NCT03600805|Drug|Prednisone|Pharmaceutical form:tablets or capsules Route of administration: oral administration
15906317|NCT03600805|Drug|Prednisone matching placebo|Pharmaceutical form:capsules Route of administration: oral administration
15906318|NCT03600792|Genetic|whole exome sequencing (WES)|"WES analysis will be performed in the UF de Génomique du Développement (APHP, Pitié-Salpêtrière hospital), using DNA extracted from amniotic fluid for the foetus (also used for chromosomal studies) and DNA extracted from peripheral blood for both parents. There will be no supplemental invasive sampling for this study. The result of WES will be returned during a consultation with the geneticist and the associated prognosis will be explained in case of molecular diagnosis"
15906319|NCT03600779|Device|inhomogeneous Magnetisation Transfer (ihMT) sequence|robust technique has shown great sensitivity for evaluating the demyelination processes using MRI at 1.5T
15906320|NCT03600779|Device|inhomogeneous Magnetisation Transfer (ihMT) sequence at 3T|robust technique has shown great sensitivity for evaluating the demyelination processes using MRI at 3T
15906321|NCT03600766|Drug|Mirabegron|oral mirabegron 50 gm plus tamsulosin 0.4 mg once daily for 8 weeks.
15906322|NCT03600766|Drug|placebo|oral toltordine 4 mg plus tamsulosin 0.4 mg daily for 8 weeks.
15906323|NCT03600753|Other|culturomic|Culturomic is a high-throughput culture strategy based on the multiplication of culture conditions coupled with the rapid identification of bacteria by MALDI-TOF (Matrix-Assisted Laser Desorption / Ionization-Time-Of-Flight) mass spectrometry
15906324|NCT03600753|Other|Metagenomic|Metagenomics is an high throughput sequencing and will be performed using Miseq ( Illumina technology) targeting the V3-V4 hypervariable regions of the 16S RNA gene.
15906325|NCT03600740|Device|DBS Programming|DBS Programming may be temporarily altered based on imaging data to measure a change in clinical symptoms.
15906326|NCT03600727|Drug|Propofol|Propofol will be used to offer intraoperative sedation for patients in Propofol group.
15906327|NCT03600727|Drug|Dexmedetomidine|Dexmedetomidine will be used to offer intraoperative sedation for patients in Dexmedetomidine group.
15906328|NCT03600714|Drug|Peg-interferon lambda|Peg-interferon Lambda is a covalent conjugate of human recombinant non- pegylated IFN lambda and a 20-kDa linear PEG chain.
15906329|NCT03600714|Drug|Lonafarnib|Oral prenylation inhibitor
15906330|NCT03600714|Drug|Ritonavir|Booster of lonafarnib action
15906333|NCT03600688|Device|Edwards Cardioband System|Transcatheter mitral valve repair
15906334|NCT03600675|Other|No intervention element, observational study.|No intervention will be applied to any group. It is an observational study and all measurements are collected during one visit.
15906335|NCT03600662|Other|TriRec|Trileaflet Reconstruction of the Aortic Valve
15906336|NCT03600662|Other|Aortic valve replacement|Biological Prosthesis, Device: St. Jude Medical Trifecta GT
15906337|NCT03600649|Drug|Seclidemstat|Twice daily administration of seclidemstat
15906338|NCT03600649|Drug|Cyclophosphamide|250 mg/m2/day on Days 1 thru 5 of a 21-day cycle
15906339|NCT03600649|Drug|Topotecan|0.75 mg/m2/day on Days 1 thru 5 of a 21-day cycle
15906430|NCT03599830|Other|Cognitive test passations|"Tests :
~MoCA2 Hopkins verbal learning test WAIS-IV Trail Making test Stroop Verbal fluences"
15906340|NCT03600636|Procedure|Diffusion tensor imaging MRI|"axial diffusion weighted sequence with 32 gradient encoding directions and two values b, 0 s / mm 2 and 1000 s / mm 2.
~Fluid-attenuated inversion recovery
~three-dimensional axial image weighted in T1
~axial echo-planar image sequence
~three-dimensional pulse sequence axial flight time"
15906341|NCT03600623|Drug|Folfirinox|SBRT will follow Folfirinox at the completion of Cycle 2 (if eligible).
15906342|NCT03600623|Drug|Gemcitabine nab-Paclitaxel|SBRT will follow Gemcitabine nab-Paclitaxel at the completion of Cycle 2 (if eligible).
15906343|NCT03600610|Device|gadolinium-enhanced cardiac MRI|cardiac magnetic resonance imaging with gadolinium injection used T1-Mapping
15906344|NCT03600584|Procedure|Modified one-layer duct-to-mucosa Pancreaticojejunostomy|After the completion of the preparation of the remnant pancreas for reconstruction was performed. Modified one-layer duct-to-mucosa Pancreaticojejunostomy was performed.
15906345|NCT03600584|Procedure|Invagination pancreaticojejunostomy|After the completion of the preparation of the remnant pancreas for reconstruction was performed. Invagination Pancreaticojejunostomy was performed.
15906346|NCT03600571|Procedure|medial midpatellar (MMP) portal|injection medial under horizontal patella midline was administrated with the lower limb extension
15906347|NCT03600571|Procedure|anteromedial (AM) portal|injection medial from patella tendon towards intercondylar notch was performed with the target knee 90° flexion
15906348|NCT03600545|Other|Brain Fitness App|Brain exercises using an iPAD
15906349|NCT03600532|Behavioral|Teachable Moment Brief Intervention (TMBI)|Behavioral intervention informed by Collaborative Assessment and Management of Suicidality and Dialectical Behavior Therapy/Cognitive Behavior Therapy to assist in positive recovery trajectory following a suicide attempt.
15906350|NCT03600519|Device|NOTAL OCT V2.5|AMD Patients
15906351|NCT03600506|Drug|Dexmedetomidine|Patients will receive infusion of study drug intravenously 10 minutes before induction of anesthesia as 1 mcg/kg over 10 min followed by 0.4 mcg/kg/hr till the start of wound closure.
15906352|NCT03600506|Drug|Placebo|Fifty ml of Placebo (normal saline) will be prepared and given intravenously by a syringe pump over 10 minutes initially and then over 1 hour till the start of wound closure.
15906353|NCT03600493|Drug|Dexmedetomidine|Dexmedetomidine 1 mcg/kg over 10 min followed by 0.4 mcg/kg/hr. till the start of wound closure.
15906354|NCT03600493|Drug|Lidocaine|Lidocaine given as 1mg/kg over 10 min followed by 1mg/kg/hr till the start of wound closure.
15906355|NCT03600480|Drug|NNC0174-0833|Participants will receive increasing dose levels of 0.16 mg, 0.3 mg, 0.6 mg, 1.2 mg, 2.4 mg or 4.5 mg of NNC0174-0833 (subcutaneous [s.c.], in a lifted fold of the abdominal skin) injection once weekly starting with a very low dose and then escalated every 4 weeks to a slightly higher dose each time. Each participant will only be given one dose level.
15906356|NCT03600480|Drug|Semaglutide|Participants will receive 2.4 mg of semaglutide (s.c., in a lifted fold of the abdominal skin) injection once weekly starting with a very low dose and then escalated every 4 weeks to a slightly higher dose each time.
15906357|NCT03600480|Drug|Placebo (NNC0174-0833)|Participants will receive once weekly injections of NNC0174-0833 matched placebo.
15906358|NCT03600467|Drug|SEVI-D (Seviteronel in combination with dexamthasone)|"Use of SEVI-D (Serivteronel and dexamethasone) in the treatment of androgen receptor positive solid tumours.
~Serivteronel will be administered orally at 450 mg (3 tables) once daily. It will be given in combination with one oral tablet of 0.5 mg tablet of Dexamethosone. SEVI-D will be continuously administered daily while on the study.
~Clinical and safety assessments are scheduled every 4 weeks during the study and then every 8 weeks after the end of the safety follow up period of the study."
15906359|NCT03600454|Drug|General anesthesia|The induction of general anesthesia will be delivered in a standardized manner with the intravenous administration of fentanyl 2µg/kg and propofol
15906360|NCT03600454|Drug|Spinal anesthesia|The level of puncture will be L4 - L5. 10 mg bupivacaine will be injected in the subarachnoid space, after spontaneous surge of cerebrospinal fluid
15906361|NCT03600454|Drug|General anesthesia and epidural analgesia|The induction of general anesthesia will be delivered in a standardized manner with the intravenous administration of fentanyl 2 µg/kg and propofol. A thoracic epidural catheter will be placed with 3 ml of xylocaine 2% (with epinephrine 1/200.000).
15906362|NCT03600441|Drug|Abexinostat|Abexinostat tosylate salt is formulated into an oral tablet formulation and is available in 20 mg strength.
15906363|NCT03600428|Biological|Live Attenuated Influenza Vaccine (LAIV)|1 dose, 0.2 mL, intranasal administration
15906364|NCT03600428|Biological|Inactivated Influenza Vaccine (IIV)|1 dose, 0.5 mL, intramuscular administration
15906365|NCT03600415|Other|Low altitude: 470m above sea level|Assessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure
15906366|NCT03600415|Other|Säntis; 2500m above sea level|Exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hours
15906367|NCT03600402|Other|Experimental|6 sessions of ankle manual therapy
15906368|NCT03600402|Other|Control|6 sessions of placebo intervention
15906369|NCT03600389|Behavioral|Patient Priorities Care|
15906370|NCT03600376|Drug|Ryanodex and Standard of Care|Ryanodex to be administered as a rapid IV push
15906371|NCT03600376|Other|Standard of Care|Body cooling measures and supportive measures
15906372|NCT03600363|Drug|Metformin|metformin (1.0g, bid) as a maintenance therapy in patients with complete remission
15906373|NCT03600363|Drug|Placebos|oral placebos as a maintenance therapy
15906374|NCT03600350|Biological|pTVG-HP|Plasmid DNA vaccine encoding Prostatic Acid Phosphatase (PAP)
15906375|NCT03600350|Drug|Nivolumab|Nivolumab is a human programmed death receptor-1 (PD-1)-blocking antibody indicated for the treatment of patients with multiple different types of cancer.
15906376|NCT03600350|Drug|GM-CSF|Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a growth factor that supports the survival, clonal expansion and differentiation of hematopoietic progenitor cells including dendritic antigen presenting cells.
15906377|NCT03600337|Behavioral|Working to Optimize Wellness in Tees with PCOS (WOW)|5 week, 75 minutes weekly, integrated mindfulness-based mental and physical health promotion intervention
15906499|NCT03599258|Device|Standard Therapy|Both devices are considered standard therapy
15906378|NCT03600324|Behavioral|T-REV|For any intervention that involves physical exercise, four parameters must be specified to complete the prescription; Type (mode), Intensity, Frequency, and Time. o The standard of care vestibular rehabilitation exercise program consists of three types of treatments that target the specific impairments and limitations discovered during the examination. The three types are: 1) gaze stabilization for vestibulo-ocular reflex dysfunction, 2) visual-vestibular habituation exercise for visual motion sensitivity, and 3) balance exercises for standing balance or gat dysfunction.
15906379|NCT03600311|Other|Caloric Restriction|Participants will consume 15 kcal/kg FFM/day.
15906380|NCT03600311|Dietary Supplement|Post-Exercise Protein|Participants will ingest 30 g of protein following exercise.
15906381|NCT03600311|Other|Energy Balance|Participants will consume 40 kcal/kg FFM/day.
15906382|NCT03600311|Dietary Supplement|Post-Exercise Carbohydrate|Participants will ingest 30 g of carbohydrate following exercise.
15906383|NCT03600311|Dietary Supplement|Calcium and Vitamin D|Participants will be supplied Calcium and Vitamin D supplements throughout the study period matched to the CON condition.
15906384|NCT03600298|Other|Simulation|Intervention phase: Study participants will be subjected to on-site simulation training focusing on communication, including CRM and non-technical skills in the PICU setting.
15906385|NCT03600285|Device|TB1-K|Use of TB1-K for preservation and transport of donated kidneys
15906386|NCT03600272|Procedure|Combined spinal-epidural analgesia|Combined spinal-epidural analgesia during labor is a labor analgesia technique which reported maybe associate with a shorter labor duration compared to the traditional epidural labor analgesia.
15906387|NCT03600272|Procedure|Epidural analgesia|Epidural analgesia is a well-accepted technique using for pain relief during labor.
15906388|NCT03600246|Device|WATCH-PAT|WatchPAT is an FDA-approved portable diagnostic device that uniquely uses finger based physiology and innovative technology to enable simple and accurate Obstructive Sleep Apnea (OSA) testing while avoiding the complexity and discomfort associated with traditional air-flow based systems.
15906389|NCT03600233|Drug|CVM-1118|"Patients will initially receive CVM-1118 orally twice daily at 200 mg per dose (400 mg total daily dose).
~Patients who tolerate this dose for at least 2 Cycles will have the option of increasing the dose of CVM-1118 to 300 mg BID (600 mg total daily dose) if specific criteria are met."
15906390|NCT03600220|Other|acupuncture|antihypertension drug, acupuncture twice a week for 3 months
15906391|NCT03600207|Other|Complex training|The training program contains stretching, mobilizing, strengthening exercises on the trunk and hip muscles and a proprioceptive training.
15906392|NCT03600207|Other|Diaphragm training|The training program contains strengthening exercises on the diaphragm muscle.
15906393|NCT03600194|Device|PowerSleep Stim|The PowerSleep Stim device is a wearable and non-invasive device, consisting of a headband with 2 electrodes (one forehead and one mastoid) and speakers covered by foam over each ear. The headband is connected via a tether cable to a user interface which houses the EEG amplifier and electronics of the device. The headband is adjusted via Velcro closure. The device also includes a right mastoid electrode EEG will be recorded by the PowerSleep device. Soft audio tones (below 65dB) will be administered via the speakers system during deep sleep as determined by the functionality of the device. The version being used for this study is considered investigational as this is an earlier version which allows the study team will be able to review EEG data recorded by the PowerSleep device in real time.
15906394|NCT03600194|Device|Northwestern Stim|The Northwestern Stim Device will function similarly to the PowerSleep device, but stimulation will be provided using a standard PC (computer) setup at the bedside using standard PSG electrodes. EEG will be monitored and slow wave sleep (SWS) identified using a standard PSG channels (international 10-20 system: Fpz, F3, F4, C3, C4, P3, P4, O1, O2) referenced to left mastoid. Electro-oculogram (EOG) will be recorded using 2 electrodes placed lateral to each eye and chin electromyogram (EMG) was recorded using 3 chin electrodes. The full EEG data set will be collected using Brain Vision Recorder software (Brain Products GmBH) and stored for off-line analysis and sleep scoring. A Matlab script (R2014b, MathWorks, Natick, MA) was developed for online detection of slow-waves and to control acoustic stimulation in a phase-locked manner (targeting the up phase of the slow wave). Acoustic stimulation will be provided by headphones with an audible soft volume that do not result in arousals.
15906395|NCT03600194|Device|PowerSleep Sham|The PowerSleep Sham device is a wearable and non-invasive device, consisting of a headband with 2 electrodes (one forehead and one mastoid) and speakers covered by foam over each ear. The headband is connected via a tether cable to a user interface which houses the EEG amplifier and electronics of the device. The headband is adjusted via Velcro closure. The device also includes a right mastoid electrode EEG will be recorded by the PowerSleep device. There are no audio tones played in the Sham condition. The version being used for this study is considered investigational as this is an earlier version which allows the study team will be able to review EEG data recorded by the PowerSleep device in real time.
15906396|NCT03600194|Device|NorthWestern Sham|The Northwestern Sham device is set up will function similarly to the PowerSleep prototype. EEG will be monitored and SWS identified using a standard PSG channels (international 10-20 system: Fpz, F3, F4, C3, C4, P3, P4, O1, O2) referenced to left mastoid. Electro-oculogram (EOG) will be recorded using 2 electrodes placed lateral to each eye and chin electromyogram (EMG) was recorded using 3 chin electrodes. The full EEG data set will be collected using Brain Vision Recorder software (Brain Products GmBH) and stored for off-line analysis and sleep scoring. A Matlab script (R2014b, MathWorks, Natick, MA) was developed for online detection of slow-waves. Participant will wear headphones but no audio tones played in the Sham condition.
15906397|NCT03600181|Device|RAD - 97 pulse co-oximeter|"non-invasive sensor capable of measuring ORI (Rainbow® Sensor, R2-25, Revision L, Masimo Corp.) will be applied to the third or fourth finger on the contralateral side of the inflatable cuff for non-invasive blood pressure monitoring.
~Values from the RAD 97 monitor will be blinded to clinicians who perform intubation (clinical research nurse will be in charge of watching RAD 97 monitor)"
15906398|NCT03600168|Device|PuraStat®|Synthetic haemostatic material
15906399|NCT03600155|Biological|Ipilimumab|Given IV
15906400|NCT03600155|Biological|Nivolumab|Given IV
15906501|NCT03599232|Other|Formative objective structured clinical examination (OSCE)|
15906502|NCT03599219|Biological|sample|confirmation of platelet dysfunction
15906503|NCT03599206|Drug|Ozone|Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing Ozone (O3).
15906401|NCT03600142|Behavioral|Mashia|Maisha is a brief, scalable, theory-based counseling intervention that addresses HIV stigma at entry into antenatal care. The intervention will be developed in a formative phase and includes 1) a video and counseling session prior to HIV testing that addresses HIV stigma, and 2) two post-test HIV counseling sessions for HIV-infected individuals, building on the video content to provide emotional support, address stigma, and reinforce the value of care engagement.
15906402|NCT03600129|Procedure|Qadratus Lumborum Block|Bilateral, ultrasound - guided Quadratus Lumborum Block
15906403|NCT03600129|Drug|30 milliliters of 0.375% Ropivacaine|30 milliliters of 0.375% Ropivacaine used for Quadratus Lumborum Block
15906404|NCT03600129|Drug|30 milliliters of 0.9% NaCl|30 milliliters of 0.9% NaCl used for Quadratus Lumborum Block
15906405|NCT03600116|Drug|Insulin Lispro|Subjects will be given an insulin injection with insulin lispro (Humalog) to correct them for their breakfast meal and to correct their plasma glucose value down to 40mg/dL.
15906406|NCT03600103|Behavioral|Tech2Check|The intervention uses behaviors to improve HIV adherence and self-care. Investigators will use the Center for Disease Control (CDC) Partnership for Health (PfH) Medication Adherence.The CHN will administer PfH at all home/venue-based encounters, using communication styles that are more receptive to adolescents and young adults. Resources will be provided. At the end of the session, the participant will be able to state/demonstrate: goals of HIV care and adherence, meaning of CD4 and Viral Load (VL) measurements and the significance of their own measurements,signs of complications or problems for which participants need to seek additional care,understanding of optimal self-care.Further, CHNs will also provide tips to stay on schedule with taking their ART and problem-solve adherence barriers.
15906407|NCT03600090|Biological|EOC202|EOC202 will be SC injection.
15906408|NCT03600090|Drug|Paclitaxel|Paclitaxol will be IV injection
15906409|NCT03600064|Drug|Misoprostol|the women will be received two tablets of misoprostol 400 mcg vaginally before IUD removal (Misotac®; Sigma Pharma, SAE, Egypt).
15906410|NCT03600051|Device|Automated Heart Murmur Detection AI|"Automated AI algorithm-based analysis of digital heart sound recordings to detect pathological heart murmurs. Heart sound recordings were fully blinded before undergoing one-time automated analysis. Algorithm results for each recording included: AHA classification (I pathologic versus III innocent/no murmur), murmur timing, murmur grade, heart rate and S1/S2 identification."
15906411|NCT03600038|Behavioral|Experimental smoking cessation smartphone app|The experimental arm includes an intervention using a novel/experimental smartphone smoking cessation app.
15906412|NCT03600038|Behavioral|Standard of care smoking cessation smartphone app|The control intervention uses a standard of care smartphone smoking cessation app.
15906413|NCT03600025|Biological|Typbar-TCV vaccine|vaccine will receive intramuscularly
15906414|NCT03600012|Other|Cycling Functional Electrical Stimulation|
15906415|NCT03600012|Other|Physiotherapy|
15906416|NCT03599999|Drug|Adverse events detection|type of adverse events detected during treatment with Temocillin and imputed to Temocillin
15906417|NCT03599973|Other|Plasmalyte A Viaflo|Fluid therapy to be given according to the principle of 4-2-1 (4 ml of crystalloid fluid for each of the first 10 kg of weight (0-10 kg), 2 ml of crystalloid fluid for each of the second 10 kg of weight (11-20 kg) and 1 ml of crystalloid fluid for each kg of weight over 20.
15906418|NCT03599960|Drug|Chemotherapy|"Idarubicin 12mg/m2 IV at D1
~Methotrexate : 3000 mg/m2 IV at D1 (24H infusion, dosing modification (1500 mg/m²) if CrCl between 50 to 80ml/min or Age ≥70y, alkaline hydration, leucovorin rescue)
~L-asparaginase (KIDROLASE) : 6000 units/m2 IV at D2, 4, 6, 8 (switch to Erwinia asparaginase 25 000 U/m² with the same drug regimen in case of hypersensitivity reactions or significant diminution of asparaginase activity)
~Dexamethasone 40mg PO or IV at D1-4 (dose diminution at 20 mg for Age ≥70y)"
15906419|NCT03599934|Other|Lifestyle integrated functional exercise program|Lifestyle-integrated exercise training targeting to improve strength and balance. Strategy to embed the exercise in the daily activity would also be taught so that the life exercise can be performed at any time of the day. The exercise would be taught in 6 home visits over 6-months.
15906420|NCT03599934|Other|Home safety assessment|Home safety assessment and modification that targets to reduce environmental risk factors of falls.
15906421|NCT03599921|Behavioral|Family-based treatment|"Family-based treatment, or FBT, is the leading evidenced based therapy for children and adolescents with an eating disorder.
~The treatment is a talking type of treatment that involves the whole family and primarily focuses on helping parents play an active and positive role in helping to restore the patient's weight, then hand control of eating back to the patient as is age appropriate. Toward the end of treatment, it is concerned with developmental issues that may have been impacted by the illness."
15906422|NCT03599921|Behavioral|Enhanced Cognitive behavioral therapy|"Enhanced Cognitive behavioral therapy, or CBT-E, is a leading evidence based treatment for adolescents and adults with an eating disorder.
~The treatment is a one-to-one talking type of treatment that primarily focuses on what is keeping the eating problem going. It is therefore mainly concerned with the present and the future. It addresses the origins of the problem as needed."
15906423|NCT03599921|Behavioral|Family-based treatment modified for ARFID|"Family-based treatment modified for individuals with an ARFID diagnosis is a proposed therapy for treating ARFID.
~The treatment is a talking type of treatment that involves the whole family and primarily focuses on helping parents play an active and positive role in helping to restore patient's weight and variety in eating, as needed."
15906424|NCT03599921|Behavioral|FBT + UP for ARFID|"Family-based treatment combined with the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents is a proposed therapy for treating ARFID.
~The treatment is a talking type of treatment that involves the whole family and begins with focus on psychoeducation, family engagement, and weight gain as needed. The Unified Protocol is then added to build skills that empower the patient to cope with difficult emotions, address avoidance, and increase tolerance of emotions or disgust responses."
15906425|NCT03599895|Procedure|3D printing model|Combine the 3D printing technique with imaging examination ,making the 3D model of da Vinci robot assisted radical gastrectomy
15906426|NCT03599895|Procedure|non 3D printing model|da Vinci robot assisted radical gastrectomy
15906427|NCT03599882|Device|Fibroscan|Fibroscan with controlled attenuation parameter and transient elastography
15906428|NCT03599856|Other|TraceBook|TraceBook offers the user intelligent dynamic clinical checklist that shows patient specific items to a specific user while being context aware.
15906431|NCT03599817|Behavioral|Healthy lifestyle promotion program|Before implementing the healthy lifestyle program, it will be adapted according to the characteristics of the Yaqui community, their type of food and the activities they carry out, so that the intervention program is culturally accepted by the community. The intervention will consist of two stages, an intensive phase and a maintenance phase. In the intensive phase, 16 weekly group sessions will be given with the aim of achieving a 5% body weight loss and ensuring that the participants do at least 150 minutes of physical activity per week. In the maintenance phase, 6 monthly group sessions will be given in order to maintain the results achieved in the first stage. In the same maintenance phase, but from 12 to 18 months, the lifestyle trainers will make home visits to the participants. Lifestile trainers will record body weight, physical activity and food consumption. In this period there will be no sessions, only monthly visits.
15906432|NCT03599791|Drug|Azelastine Hydrochl./Fluticasone Prop. 0.137/0.05 MG/ACTUAT|Dymista Nasal spray suspension
15906433|NCT03599791|Drug|Azelastine Hydrochloride 0.137 MG/ACTUAT|AZEP Nasal spray solution
15906434|NCT03599791|Drug|Fluticasone Propionate 0.05 MG/ACTUAT|Fluticasone propionate nasal spray suspension
15906435|NCT03599778|Drug|Apatinib|XELOX + apatinib's MTD
15906436|NCT03599765|Other|Best Practice|Receive routine therapy
15906437|NCT03599765|Procedure|Local Consolidation Therapy|Receive LCT
15906438|NCT03599752|Drug|Chemotherapy|Receive chemotherapy
15906439|NCT03599752|Procedure|Metastasectomy|Undergo pulmonary metastasectomy
15906440|NCT03599739|Biological|Influenza|Facilities will be asked to complete a survey to evaluate the impact of the influenza vaccine choice on hospitalization risk for the 2017-2018 influenza season.
15906441|NCT03599726|Drug|Donepezil|Donepezil 5 mg per day for week 1-2 or 5-6
15906442|NCT03599726|Drug|Placebo|Placebo 5 mg per day for week 1-2 or 5-6
15906444|NCT03599700|Diagnostic Test|myeloproliferative neoplasms|BLOOD SAMPLING
15906445|NCT03599687|Other|Training in SALAD technique|The training session will be delivered, and will take around 45 minutes to complete, including time for participant practice. The training intervention will adopt the Advanced Life Support Group/Resuscitation Council 4-stage approach of skills teaching, and is comprised of: A real-time demonstration of the SALAD technique by the researcher; A repeated demonstration with an explanation of the rationale of the steps taken when performing SALAD (not real-time); Another demonstration of the SALAD technique conducted by the researcher, but guided by one of the participants; An attempt by the same participant who guided the researcher in the previous step, followed by a practice attempt by the other participants.
15906446|NCT03599674|Behavioral|Family Bridge Program|Families receive Family Bridge Program services which include orientation to the hospital, concrete needs assessment, communication preferences assessment, communication coaching, follow-up during the hospital stay, and a follow-up phone call after discharge.
15906447|NCT03599661|Other|Interview|Participants will review a computer prototype of Fertilit-e alpha. Using an interview guide, participants will be asked about issues of content, functionality, and ease of use (i.e., comprehensibility and usability). Interviews will be completed within 45-60 minutes.
15906448|NCT03599661|Other|Questionnaire Administration|All participants will complete an interviewer administered screener for health literacy and self-report items for technology use, eHealth literacy, and need for cognition.
15906449|NCT03599648|Behavioral|BPT-M|"Participants randomized to the BPT-M condition receive the Mindfulness-Based Stress Reduction (MBSR) intervention, followed by Behavioral Parent Training (BPT). The MBSR module includes six weekly 2.5 hour group sessions, 30-45 minutes of daily home practice guided by audio CDs, and an MBSR parent workbook. In the sessions, participants practice formal mindfulness exercises, and are provided instruction on stress physiology and using mindfulness for coping with stress in everyday life.
~The BPT component of the intervention includes 10 weekly sessions lasting 2.5 hours. Each session is structured around videotape vignettes and uses discussion, role-playing, modeling, and feedback to foster mastery of the material. Parents are given weekly homework assignments and practice their skills."
15906450|NCT03599648|Behavioral|BPT-E|Participants randomized to the BPT-E condition will received 6 weeks of a psychoeducation program followed by 10 weeks of the Behavioral Parent Training (BPT) used in both conditions. The psychoeducation module consists of 6 weekly 2.5-hour sessions, daily homework that includes monitoring progress on goals identified at the end of each session, and a workbook for parents of children with special needs that provides parents with information regarding their child's development, disability, and associated considerations. Each of the 6 weekly sessions includes a general topic for discussion. These include preparing for IEP meetings, navigating the regional center and developmental service agencies, communicating with teachers, advocacy, sibling issues, and community resources.
15906451|NCT03599635|Drug|liposomal bupivacaine|Experimental
15906452|NCT03599635|Drug|Bupivacaine|Active Comparator
15906453|NCT03599622|Drug|BMS-986165|Specified dose on specified days
15906454|NCT03599622|Other|Placebo|Specified dose on specified days
15906455|NCT03599609|Drug|Simvastatin 40mg|Simvastatin 40mg, once daily
15906456|NCT03599596|Drug|Sulphadoxine-pyrimethamine|Sulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets monthly until delivery
15906457|NCT03599596|Drug|Sulphadoxine-pyrimethamine|Sulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets twice before delivery
15906458|NCT03599583|Behavioral|STOP-HPV prompts intervention|This intervention will be the addition of the prompts intervention (in the presence of communication skills training and continued performance feedback).
15906459|NCT03599570|Behavioral|STOP-HPV performance feedback intervention|This intervention will be the addition of performance feedback (in the presence of communication skills).
15906460|NCT03599557|Behavioral|STOP-HPV communication intervention|This intervention will be communication skills training.
15906461|NCT03599544|Behavioral|Robot-Assisted Therapy (RT)|Highly intensive robot-assisted therapy for the paretic arm with the Armeo exoskeleton (1 hour sessions, 3x week for 3 weeks) followed by robot-assisted therapy for hand motions with Amadeo robot (3x week for 3 weeks).
15906504|NCT03599206|Other|Filtered Air|Subjects will perform alternating 15 minutes rest with 15 minutes treadmill walk exercise periods for 135 minutes in while breathing filtered air.
15936661|NCT03367923|Other|Fitbit tracker|Wear Fitbit tracker
15906462|NCT03599544|Behavioral|Robot + Active Learning Program(RT-ALPS)|Highly intensive robot-assisted therapy for the paretic arm with the Armeo exoskeleton (1 hour sessions, 3x week for 3 weeks) followed by robot-assisted therapy for hand motions with Amadeo robot (3x week for 3 weeks). In addition, participants will receive training in active problem solving, analysis of performance and goal setting focused on home action plan activities to assist with carry-over and generalization to every day activities.
15906463|NCT03599518|Drug|DS-1205c|DS-1205c 200 mg capsule for oral administration
15906464|NCT03599518|Drug|Gefitinib|Gefitinib 250 mg tablet for oral administration
15906465|NCT03599505|Procedure|localization group|Intraoperative ultrasonographic localization will be performed using an ultrasound system (HI VISON Ascendus), which is equipped with a 5-10MHz mechanical probe (EUP-OL531). The accuracy rate of localization will be evaluated using gray scale mode and elastography mode.
15906466|NCT03599492|Diagnostic Test|SMART Pill Pre-TIPS|Assessment of motility with Smart Pill, which will be read and confirmed by gastroenterologist trained to interpret motility studies
15906467|NCT03599492|Diagnostic Test|SMART Pill Post TIPS|Assessment of motility with Smart Pill, which will be read and confirmed by gastroenterologist trained to interpret motility studies
15906468|NCT03599479|Device|Virtual reality group|Virtual reality group The study intervention is to provide acute pain management for the subject undergoing fluoroscopic pain intervention by using the virtual reality program provided by the collaborator through virtual reality device (headset, headphone, and smartphone) that are commercialized on the market.
15906469|NCT03599466|Drug|BF-Lisinopril Tablets 20mg|BF-Lisinopril Tablets 20mg is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
15906470|NCT03599466|Drug|Zestril Tab 20mg|Zestril Tab 20mg will be used as a reference drug in this study
15906471|NCT03599453|Procedure|Biopsy|Undergo Biopsy
15906472|NCT03599453|Procedure|Chemokine Modulation Therapy|Undergo chemokine modulation therapy
15906473|NCT03599453|Drug|Celecoxib|Given by mouth
15906474|NCT03599453|Biological|Recombinant Interferon Alfa-2b|Given intravenously
15906475|NCT03599453|Drug|Rintatolimod|Given intravenously
15906476|NCT03599453|Biological|Pembrolizumab|Given intravenously
15906477|NCT03599440|Other|Pressure line extensions|"Two types of extension lines are connected:
~Perfusor® line 150cm (polyethylene)
~conventional arterial extension line"
15906478|NCT03599427|Drug|systemic lidocaine|Systemic lidocaine is administrated at induction of anesthesia and at the end of surgery (1.5 mg/kg).
15906479|NCT03599427|Drug|Placebo|Placebo is administrated at induction of anesthesia and at the end of surgery (0.075 ml/kg)
15906480|NCT03599401|Other|Scaling and root planing|"Scaling and root planing was done by using ultrasonic scalers with high speed suction apparatus to prevent aerosol contamination.
~."
15906481|NCT03599388|Behavioral|Self- management for adequate sleep intervention (SASI)|Bedtimes and wake times will be prescribed each week for each participant and allow for gradual increases in sleep opportunity. Bedtimes will be set 15 minutes earlier each week provided sleep efficiency remains >90%. Earlier betimes will extend sleep duration by increasing the opportunity for sleep. Wake times will not be changed because wake times are often determined by external demands, such as work schedules
15906482|NCT03599375|Biological|CD19-targeted CART cells|CD19 CAR T cells was transduced with a lentiviral vector to express anti-CD19 scFv.This is a second generation CRAT.
15906485|NCT03599349|Device|Microfocused ultrasound w/ visualization|
15906486|NCT03599336|Procedure|Reverse Total Shoulder Arthroplasty (rTSA)|Surgical management will include placement of fracture specific, cemented reverse total shoulder arthroplasty components as per standard surgical care and routine postoperative rehabilitation.
15906487|NCT03599336|Other|Nonoperative Treatment|Subjects allocated to the nonoperative treatment arm will maintain sling immobilization for 3 weeks. The sling will be removed for elbow, wrist and hand range of motion (ROM), hygiene, and dressing only. At 3 weeks passive ROM in external rotation (ER) and forward elevation (FE) will be added. At 6 weeks from injury, the sling will be removed and stretching in all planes will be allowed. Use of the arm will be up to a fork/knife/toothbrush only. At 3 months from injury, strengthening will be added. Supervised physical therapy will be offered to patients for use at their discretion, as is current practice.
15906488|NCT03599323|Drug|Clotrimazole 1% (Empecid L Cream, BAYB5097)|Consumers who self-select and are then deemed appropriate users of the product by the pharmacist for treatment of Vulvar itching with rash due to recurrent vaginal candida (only in patients previously diagnosed and treated by a doctor).
15906489|NCT03599310|Behavioral|Advance care planning|The ACP guide is adapted from the Serious Illness Communication Guide and a culturally-sensitive ACP programme developed in the local context. The trained ACP facilitators will initiate the conversation by introducing the concepts of ACP with the support of the guide and assessing the patient's illness understanding and readiness to think about end-of-life care issues.
15906490|NCT03599310|Behavioral|Usual care|In the current practice, patients will have to take the initiative themselves if they would like to discuss their end-of-life care or make an advance directive.
15906491|NCT03599297|Procedure|Bilateral synchronous simultaneous stone surgery|Patients undergoing Bilateral synchronous simultaneous stone surgery (one kidney undergoing percutaneous nephrolithotomy, other kidney undergoing ureteroscopy at the same time in a single patient)
15906492|NCT03599284|Drug|Vicagrel 5mg|Experimental group 1 : Vicagrel 20mg loading followed by 5mg/day for 28 days
15906493|NCT03599284|Drug|Vicagrel 6mg|Experimental group 2 : Vicagrel 24mg loading followed by 6mg/day for 28 days
15906494|NCT03599284|Drug|Vicagrel 7.5mg|Experimental group 3 : Vicagrel 30mg loading followed by 7.5mg/day for 28 days
15906495|NCT03599284|Drug|Clopidogrel 75mg|Control group : Clopidogrel 300mg loading followed by 75mg/day for 28 days
15906496|NCT03599271|Device|Drug-Coated Device|3000 mcg mometasone furoate-coated sinus dilation device
15906497|NCT03599271|Device|Control Device|Sinus dilation device without drug
15906498|NCT03599258|Device|Skylife|Newly FDA approved device
15906505|NCT03599193|Drug|Tazarotene Lotion, 0.1%|DFD-03 (Tazarotene Lotion, 0.1%) applied Twice Daily for 1 minute and rinsed off
15906506|NCT03599193|Drug|Tazarotene Cream, 0.1%|Tazorac® (tazarotene) Cream, 0.1% applied Once Daily and left for approximately 12 hours
15906507|NCT03599180|Device|microdialysis|Use microdialysis skill to collect dialyzate at sensitization acupoints
15906508|NCT03599141|Behavioral|Trust-building Self-management Together|Trust building plus depression self-management
15906509|NCT03599141|Behavioral|Depression Management|Traditional depression self-management
15906510|NCT03599128|Other|43.3 mg hydrolyzed green coffee extract|Reconstituted in water and given to subjects
15906511|NCT03599128|Other|86.6 mg hydrolyzed green coffee extract|Reconstituted in water and given to subjects
15906512|NCT03599128|Other|173 mg hydrolyzed green coffee extract|Reconstituted in water and given to subjects
15906513|NCT03599128|Other|Placebo|Reconstituted in water and given to subjects
15906514|NCT03599115|Behavioral|Inhibitory Control Training|Computerized go/no-go task where individuals make responses to certain items (go trials) and withhold responses from certain items (no-go trials, in this case, trials surrounded by a black box). Intervention is designed to target and improve inhibitory control cognitive mechanisms in general (generic arm) or towards high-calorie foods specifically (food arm).
15906515|NCT03599102|Behavioral|LOVED Intervention|
15906516|NCT03599089|Drug|CA-008|single-dose wound infiltration prior to surgical incision closure
15906517|NCT03599089|Drug|Placebo|single-dose wound infiltration prior to surgical incision closure
15906518|NCT03599089|Drug|Ketorolac|30mg IV administered intraoperatively
15906519|NCT03599089|Drug|Acetaminophen|1000mg IV administered intraoperatively
15906520|NCT03599089|Drug|Oxycodone|5mg PO prn post-surgery
15906521|NCT03599089|Drug|Bupivacaine Hydrochloride|0.5% infiltration pre-surgery
15906522|NCT03599076|Other|HD Wear|Wearable sensor system for monitoring Huntington's chorea during activities of daily living
15906523|NCT03599063|Biological|PF-06946860|PF-06946860 administered subcutaneously
15906524|NCT03599063|Other|Placebo|Placebo, administered subcutaneously
15906525|NCT03599050|Behavioral|Audiotaped Counseling Session|Patients and nurses will complete audio taped counseling session at least 3 months following the baseline visit. Patients will rate quality of nurse communication skills
15906526|NCT03599037|Other|ICOUGH Recovery App v2.0|"The app has pre-set auditory, visual reminders, in the form of push notifications, that remind participants to use the incentive spirometer and ambulate around the hospital at time intervals recommended by the ICOUGH protocol. The app benchmarks the level of adherence to that of other subjects involved in the study via the My Summary page, and this visual anonymous comparison further motivates adherence to the ICOUGH protocol."
15906527|NCT03599024|Procedure|PCEA|The patients were able to control the administration of analgesics by themselves.
15906528|NCT03599024|Procedure|Non-PCEA|The patients were receiving analgesics according to the physician's prescription.
15906529|NCT03599024|Procedure|Total hip replacement|All patients enrolled in the study were indicated for total hip replacement surgery.
15906530|NCT03598998|Biological|Pembrolizumab|Given IV
15906531|NCT03598998|Drug|Pralatrexate|Given IV
15906532|NCT03598985|Diagnostic Test|"Smartphone MyAnkle balance application"|"Balance will be assessed simultaneously using MyAnkle application and the Biodex balance system. The smartphone will be fixed to the middle of the shin with an armband. Participants will assume a single leg stance on each side under two conditions: eyes opened and closed. Testing will be done at three levels of difficulty; least difficult (level 8), moderate (level 6) and severe difficult (level 4). A conditioning trial for each level will be given for 30 seconds. Further, a 2-minute rest between tests will be given. During the testing, participants should not touch the ground or stance limb by other limb nor to grasp the handrail. Participants will repeat the same testing in two separate sessions, with one-week interval in between."
15906533|NCT03598972|Other|intervention|elementary analysis
15906534|NCT03598959|Drug|tofacitinib|orally 10 mg daily
15906535|NCT03598959|Drug|chidamide|orally 20 mg twice weekly
15906536|NCT03598946|Device|Urinary test|Women use a home urinary test themselves
15906537|NCT03598920|Device|AsspireAssist|Endoscopic bariatric procedure using the AsspireAssist device
15906538|NCT03598920|Other|Nutritional consulting|Nutritional consulting provided by a specialized consultant.
15906539|NCT03598907|Other|Fresh frozen plasma|Fresh frozen plasma will be used according to anaesthetist ,,blind,, decision
15906540|NCT03598894|Other|Ambulatory blood pressure measurements|Blood pressure will be assessed with ambulatory blood pressure measurements over the course of a day to discern day/night differences
15906541|NCT03598881|Other|Treatment|
15906542|NCT03598868|Drug|Vortioxetine|Augmentation : Vortioxetine 10 mg p.o. for week 1, Vortioxetine 5-20 mg p.o. for week 2,4,6.
15906543|NCT03598868|Drug|Placebo|Augmentation : Placebo for week 1,2,4,6
15906544|NCT03598855|Other|Ischemic Preconditioning|Ischemic preconditioning (IPC) refers to cycles of 5 minutes of upper arm cuff inflation with 5 minute periods of cuff deflations, repeated 4 times.
15906545|NCT03598842|Dietary Supplement|Nutritional Supplementation Meal|Study participants will be given a nutritional supplementation for 6 months. The supplementation consists of a vegan meal plan.
15906546|NCT03598842|Dietary Supplement|Multivitamin|Study participants will be given a daily multivitamin to take for 6 months.
15906547|NCT03598842|Drug|Anti-parasitic medications|Study participants will be given anti-parasitic medications per Indian guidelines such as albendazole, ivermectin, metronidazole, or other medications to treat their parasitic infection.
15906548|NCT03598816|Drug|Durvalumab|-Durvalumab infusion will start approximately 1 hour (maximum 2 hours) after the end of the tremelimumab infusion
15906549|NCT03598816|Drug|Tremelimumab|-Tremelimumab will be administered first
15906550|NCT03598816|Device|TDS-IM v1.0 System|-Integrated electroporation device
15906551|NCT03598816|Biological|Neoantigen DNA Vaccine|-At each vaccination time point, patients will receive two injections of the neoantigen DNA vaccine, one injection into each deltoid or lateralis.
15906552|NCT03598816|Procedure|Research blood draw|-Baseline, C2D1, C3D1, C5D1, C7D1, and C9D1
15906553|NCT03598803|Other|Survey|Urinary Incontinence Survey
15906555|NCT03598777|Biological|Botulinum toxin type A|Botulinum Toxin Type A (Dysport) using a vial of 500 U will be injected intramuscularly across pelvic floor muscles.
15906556|NCT03598777|Drug|Placebo|The reconstituted solution will be injected intramuscularly across pelvic floor muscles.
15906557|NCT03598764|Procedure|Classic head extraction during Cesarean section|by putting the fingers of the right inside the lower uterine segment to deliver the head
15906558|NCT03598764|Procedure|External pop out technique|The palmar aspect of the fingers will be resting on the uterovesical peritoneal reflection not directly on the fetal head.
15906559|NCT03598751|Drug|BCD-085|120 mg / 2 mL subcutaneously
15906560|NCT03598751|Drug|Placebo|2 mL
15906561|NCT03598738|Drug|Esomeprazole 40mg|Esomeprazole 40mg oral tablet, once a day
15906562|NCT03598725|Drug|Coagulation Factor VIII|Domastic plasma derived factor FVIII (with intermidiate vWF) 50IU/kg every other day
15906563|NCT03598725|Drug|Prednisone|2mg/kg every day for 4 weeks then typering in 3 months
15906564|NCT03598725|Drug|Rituximab|375mg/Square meter for consecutive 4 months
15906565|NCT03598712|Device|Compression by chest bandage urgo K2®|"- Installation of a short stretch belt (urgo K2® kit)
~- Installation of a long stretch cohesive band providing additional pressure necessary to reach therapeutic pressure and maintain the device (urgo K2® kit).
~- Control of the pressure exerted by the bandage by the KIKUHIME® Sub Bandge pressure Monitor device"
15906566|NCT03598712|Procedure|punctures|Every 7 days after the second puncture of a volume > 250ml of seroma, the patients are examined by 2 practitioners. They define the indication of the puncture. The seroma is aspirated after a skin puncture with a needle connected with a Redon® drain.
15906567|NCT03598699|Drug|AXR-159|AXR-159 Ophthalmic Solution
15906568|NCT03598686|Diagnostic Test|OraQuick|Most trials assessing oral HIVST make use of OraQuick® (OraQuick ADVANCE HIV I/II test kits, packaged for self-use), an oral-fluid rapid self-test. OraQuick® is a 2nd generation serology assay with a sensitivity of 99.3% (95%CI; 98.4%, 99.7%) and a specificity of 99.8% (95%CI; 99.6%, 99.9%). In a pilot study with 59 participants conducted in Lesotho in 2015 more than 90% of the participants found utilization of OraQuick® easy, and trusted the results of the self-test kit. The WHO recently has announced that OraQuick becomes the first prequalified HIV self-test, in order to improve diagnosis in low-resourced health systems and in countries where stigma prevents people from getting tested. Therefore, OraQuick® is now available in Lesotho for as little as 2 USD per test kit.
15906569|NCT03598673|Drug|The Efficacy and Tolerability of Nebivolol in Nigerians|To determine the effect of Nevibolol on office blood pressure of Blacks residing in Nigeria
15906570|NCT03598660|Genetic|Sorcin gene expression|Sorcin gene expression Will be measured by real time PCR
15906571|NCT03598660|Other|Annexin A3 serum mesurement|serum mesurement of Annexin A3 by enzyme linked immuno sorbent assay (ELISA)
15906572|NCT03598647|Behavioral|Affect and physical activity|The focus of this intervention is to help the participant to become more aware of their positive feelings and experiences related to exercise. They will learn about typical affective responses to exercise, view their own affective responses to exercise, and they will be taught cognitive strategies for altering affective responses to exercise. Participants will also receive general information about exercise safety, physical activity guidelines, and exercise intensity.
15906573|NCT03598647|Behavioral|Physical activity information|Participants will receive general information about exercise safety, physical activity guidelines, and exercise intensity.
15906574|NCT03598634|Procedure|administration of riboflavin for epi-off cross-linking|riboflavin 0.1% in 20% dextran solution
15906575|NCT03598634|Procedure|administration of riboflavin for epi-on cross-linking|riboflavin 0.1% in 15% dextran solution supplemented with tris-hydroxymethylaminomethane and sodium ethylenediminetetraacetic acid
15906576|NCT03598621|Drug|Semaglutide, 0.5 mg/mL|A single dose will be administered subcutaneously (s.c.; under the skin) in the morning after an overnight fast of at least 8 hours.
15906577|NCT03598621|Drug|Semaglutide, 1.0 mg/mL|A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.
15906578|NCT03598621|Drug|Semaglutide, 1.34 mg/mL|A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.
15906579|NCT03598621|Drug|Semaglutide, 2.0 mg/mL|A single dose will be administered s.c. in the morning after an overnight fast of at least 8 hours.
15906580|NCT03598621|Device|DV3372, 0.5 mg/mL|DV3372 device will be used for administration of semaglutide 0.5 mg/mL.
15906581|NCT03598621|Device|DV3372, 1.0 mg/mL|DV3372 device will be used for administration of semaglutide 1.0 mg/mL.
15906582|NCT03598621|Device|PDS290|PDS290 pen-injector will be used for administration of semaglutide 1.34 mg/mL.
15906583|NCT03598621|Device|NovoPen®4|NovoPen®4 will be used for administration of semaglutide 2.0 mg/mL.
15906584|NCT03598608|Biological|pembrolizumab|Administered as an IV infusion every 3 weeks (Q3W)
15906585|NCT03598608|Biological|Favezelimab|Administered as an IV infusion Q3W
15906586|NCT03598595|Drug|Docetaxel|Given IV
15906587|NCT03598595|Drug|Gemcitabine|Given IV
15906588|NCT03598595|Drug|Hydroxychloroquine|Given PO
15906589|NCT03598582|Drug|Epoetin Zeta|"Patients received epoetin zeta (Retacrit®) 40000UI/week subcutaneously during 12 weeks.
~Response has been evaluated at 12 weeks according to IWG 2006 criteria. Patients with response continued on epoetin zeta. In non-responders, the patients have been excluded from the protocol."
15906590|NCT03598569|Other|dyspnea|dyspnea assessment
15906591|NCT03598556|Dietary Supplement|Vitamin D3|180,000IU Vitamin D3 oral emulsion
15906592|NCT03598556|Other|Placebo|Placebo
15906593|NCT03598543|Other|no intervention|no intervention, this is an obervational study.
15906594|NCT03598530|Procedure|Surgery|Surgical fracture fixation, using osteosynthesis, including single or multiple staged procedures (e.g. primary External Fixation and later conversion to internal fixation).
15906595|NCT03598517|Radiation|high dose chemoradiotherapy|"Radiation therapy: 60 Gy at 2 Gy/Fx/d over 6 weeks, immediately followed by 28.8 Gy in 24 fractions of 1.2 Gy, twice per day,on weeks 6-8 to a total dose of 88.8 Gy.
~concurrent chemotherapy: weekly carboplatin area under the curve (AUC) 2 and paclitaxel 45 mg/m2 over the duration (8 weeks) of radiation therapy.
~Adjuvant chemotherapy is planned 6 weeks after high dose chemoradiation."
15906596|NCT03598504|Device|Wearable EMG/Vibration device|The device is a combination of an EMG recorder/detector and a vibrator
15906597|NCT03598478|Behavioral|TC-MPT|Participants will receive two levels of training within each 90-minute session over a 12-week period: (1) TC training and (2) MPT. The TC training protocol consists of five basic TC movements. After receiving TC training, the participants in this group will take a 5-minute break and then receive MPT. During MPT, the participants will contract their major postural muscles bilaterally as fast as possible against a resistance equivalent to 70% of one repetition maximum.
15906598|NCT03598478|Behavioral|TC|Children in the TC group will skip the MPT session and practice TC movements repeatedly for 90 minutes. The exercise progression pattern in the TC-alone group will be the same as that in the TC-MPT group.
15906599|NCT03598478|Behavioral|MPT|Those children in the MPT group will perform strengthening exercises repeatedly for 90 minutes, with a short 5-minute break between the three sets of exercises if necessary. The exercise progression pattern in the MPT-alone group will be the same as that in the TC-MPT group.
15906600|NCT03598452|Drug|Ganciclovir|Intravitreal Injection of Ganciclovir (IVG) was conducted in a week interval. The initial dose was 6mg/0.1ml at the first injection and it was reduced to 4.5mg/0.1ml at the second time; 3mg/0.1ml of IVG was maintained until the CMV could not be detected in aqueous humor.
15906601|NCT03598439|Biological|Standard IIV4|Standard inactivated influenza vaccine
15906602|NCT03598439|Biological|Recombinant|Influenza vaccine that uses a hemagglutinin protein manufactured in insect cells with a baculovirus vector
15906603|NCT03598439|Biological|Cell-culture|inactivated influenza vaccine manufactured using mammalian cell lines; current vaccine uses a cell-propagated H3N2 strain.
15906604|NCT03598426|Drug|Dexamethasone|Conventional arm will only use oral dexamethasone as intervention; Short-Course arm will only use intravenous dexamethasone as intervention; Combined arm will use both oral and intravenous dexamethasone as intervention
15906605|NCT03598413|Dietary Supplement|Omega-3|200ml, pre-mixed oral nutritional supplement supplying 1.42g per bottle of EPA and DHA.
15906606|NCT03598400|Behavioral|high intensity interval training|Participants will complete 6 sessions of high intensity interval training during a 2 week intervention period. The programme involves repeated 1 minute bouts of simple on the spot movements interspersed with 1 minute of rest.
15906607|NCT03598400|Behavioral|moderate intensity continous training|Participants will complete 6 sessions of moderate intensity continous training during a 2 week intervention period. Participants will be asked to complete 30 minutes of continuous exercise.
15906608|NCT03598387|Other|Automated peritoneal dialysis|"The prescription of automated peritoneal dialysis:
~The first 48-72 hours dose: 0.8-2.0 liter exchange with 1-2 hour-cycle (8-36 liters per day); After initial 48-72 hours, 1.0-2.5L exchange with 2-6 hour-cycle (at least 8 liters per day), if the acidosis, hyperkalemia and pulmonary edema are corrected.
~The minimal target weekly Kt/V is 2.1-3.5/W."
15906609|NCT03598387|Other|Intermittent hemodialysis|Intermittent hemodialysis will be performed 3-4h of each session and 2-5 times per week. The prescription will be adjusted based on patients' conditions to ensure spKT/V≥1.3.
15906610|NCT03598374|Dietary Supplement|Inositol + Folic acid|"Daily oral supplementation of for 6 months or until pregnancy conception:
~Myo-Inositol: 1100 mg D-chiro-inositol: 27.6 mg Folic acid: 400 mcg"
15906611|NCT03598374|Dietary Supplement|Folic acid|"Daily oral supplementation of for 6 months:
~Folic acid: 400 mcg"
15906612|NCT03598374|Behavioral|Regular intercourses|Couples are required to have regular intercourses with the aim to achieve a spontaneous conception.
15906613|NCT03598348|Drug|Apatinib+Capecitabine|Capecitabine 1000mg/m2 po bid, d1-14, Apatinib 250mg po Qd, Q21d
15906614|NCT03598348|Drug|Apatinib|Apatinib 250mg po Qd
15906615|NCT03598335|Device|Ultrasound|Ultrasound imaging of women arriving at clinic for routine care
15906616|NCT03598322|Procedure|Dextrose 1mL injection|Dextrose 1mL injection and hydrodissection for CTS
15906617|NCT03598322|Procedure|Dextrose 2mL injection|Dextrose 2mL injection
15906618|NCT03598322|Procedure|Dextrose 4mL injection|Dextrose 4mL injection
15906619|NCT03598309|Drug|Curcumin C3 complex®|Groups A and B as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.
15906620|NCT03598309|Drug|Lovaza®|Groups A and B as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.
15906621|NCT03598309|Other|Placebo|Groups B and Placebo as outlined in study arm. Drug will be dispensed by investigational pharmacists and self-administered by the participants.
15906622|NCT03598296|Other|Large size tube|Patients in Group A are inserted the large size tube (28F).
15906623|NCT03598296|Other|Drainage ball|Patients in Group B are inserted the small-bore tube connects with a negative pressure ball(drainage ball).
15906624|NCT03598283|Device|Ultrasound/transient elastography|The evaluation of the liver will be performed non-invasively with liver fibrosis scores based on standard blood parameters, the ultrasound-guided measurement of the liver size and the measurement of liver stiffness (correlated with liver fibrosis) and controlled attenuation parameter (CAP, correlated with hepatic steatosis) via transient elastography (FibroScan©, Echosens SA, Paris, France). The thyroid will be assessed by ultrasound and standard blood parameters and the pancreas by standard blood parameters only, respectively.
15906625|NCT03598270|Drug|Placebo|Volume equivalent to 1200 mg of atezolizumab drug product. Intravenous Day 1
15906626|NCT03598270|Drug|Carboplatin|Intravenous. Day 1
15906627|NCT03598270|Drug|Paclitaxel|175 mg/m². Intravenous. Day 1
15906628|NCT03598270|Drug|Niraparib|200 mg or 300 mg. Oral. From day 1 to 21
15906629|NCT03598270|Drug|Gemcitabine|1000 mg/m². Intravenous. Day 1 and day 8.
15906630|NCT03598270|Drug|Pegylated liposomal doxorubicin (PLD)|30 mg/m². Intravenous. Day 1
15906631|NCT03598270|Drug|Atezolizumab|1200 mg. Intravenous. Day 1
15906634|NCT03598244|Drug|Savolitinib|Given PO
15906665|NCT03597958|Genetic|Next generation sequencing (NGS)|NGS panel, whole exome / genome sequencing (WES/WGS), transcriptome analysis
15906666|NCT03597945|Procedure|lidocaine with epinephrine|lidocaine with epinephrine in prehospital femoral nerve block for patient with diaphysial femoral fracture
15906667|NCT03597945|Procedure|normal saline|normal saline as adjuvant to lidocaine with epinephrine in prehospital femoral nerve block for patient with diaphysial femoral fracture
15906635|NCT03598231|Device|Sacral neuromodulation|"After the definitive implantation, stimulators are placed in position OFF for the first arm and in position ON for the second arm during 4 weeks.
~Then all the stimulators are switched OFF (both first and second arms) for 2 weeks.
~Finally stimulators are maintained in position ON for the first arm and switched OFF for the second arm during 4 weeks.
~Since this is a cross-over study, patients can be randomly assigned to any arm first, but they will go to the other arm since the patient is its own control. 50% of randomized patients will go through ON-OFF and the other 50% OFF-ON.
~After this cross-over phase, ALL stimulators will be in ON position until the end of the study period."
15906636|NCT03598218|Radiation|Hypofraction radiation|"Hypofractionated dose IMRT: GTVnx 60Gy, GTVnd 60Gy, PTV1 50Gy and PTV2 45Gy in 25 fractions, 5 days/week.
~Induced chemotherapy: Paclitaxel 135mg/m2 D1+Cisplatin 80mg/m2 D1(or D1-3), 3-week chemotherapy for 3 cycles. After radiation, patients receive adjuvant chemotherapy Paclitaxel 135mg/m2 D1+Cisplatin 80mg/m2 D1(or D1-3), 3-week chemotherapy for 3 cycles."
15906637|NCT03598218|Radiation|Standard dose IMRT|"Standard dose IMRT: GTVnx 69.69Gy, GTVnd 60-68Gy, PTV1 54.9Gy and PTV2 54Gy in 33 fractions, 5 days/week.
~Induced chemotherapy: Paclitaxel 135mg/m2 D1+Cisplatin 80mg/m2 D1(or D1-3), 3-week chemotherapy for 3 cycles. After radiation, patients receive adjuvant chemotherapy Paclitaxel 135mg/m2 D1+Cisplatin 80mg/m2 D1(or D1-3), 3-week chemotherapy for 3 cycles."
15906638|NCT03598205|Combination Product|DIABEC plus intravitreal dexamethazone|Patients with diabetic macular edema undergoing to intravitreal dexamethazone will be randomized to curcumin formulation (DIABEC)
15906639|NCT03598192|Procedure|TAP|The TAP group will be performed at four points at abdominis plane with ropivacaine 0.375%
15906640|NCT03598192|Procedure|PVB|The PVB group will be performed at paravertebral space T7 with ropivacaine 0.5%
15906641|NCT03598192|Drug|Ropivacaine|Ropivacaine has been treated the both group
15906642|NCT03598192|Drug|Sufentanil|Sufentanil has been included in Arm/Group Descriptions
15906643|NCT03598179|Biological|chimeric antigen receptor T cells|Dose CAR+ cells/kg B-cell lymphoma 4×10^6 Acute lymphocytic leukemia 2×10^6 Chronic lymphocytic leukemia 10×10^6
15906645|NCT03598153|Drug|Shujinjianyao Pill|According to the usage and dosage of the instructions, patients should use the medicine dialectically and rationally for 4 weeks.
15906646|NCT03598140|Drug|Sildenafil Citrate|Sildenafil 60mg once (Group 1) or daily for 2 weeks (Group 2)
15906647|NCT03598140|Drug|Placebo oral capsule|Placebo once (Group 1) or daily for 2 weeks (Group 2)
15906648|NCT03598114|Behavioral|Program Sustainability Action Planning Model and Training Curricula|The Program Sustainability Action Planning Model and Training Curricula's conceptual model is driven by the theory of change and incorporates aspects of Kolb's experiential learning theory to produce a six step process: defining the program, assessing the program, developing an action plan, executing the action plan, evaluating sustainability, and reassessing and modifying. The study team will deliver in-person, hand-on workshops incorporating each of these aspects of the conceptual model. Following the workshop, intervention states will partake in technical assistance activities with the study team to track progress and troubleshooting challenges.
15906649|NCT03598101|Device|TONEFITreha|The newly developed Tonefit Reha is based on the existing fitness device, the TONEFIT belt. Similar to Nordic Walking, the device aims to include upper limb activity in walking exercise to train the shoulder girdle and arm. While Nordic Walking uses poles, the existing TONEFIT belt uses body-worn resistance handles to actively involve the upper body. It is worn around the waist, like a belt. The two independent pull-push elements with non-adjustable resistance on each side allow increased intensity for strengthening and endurance training during walking, particular for upper extremities and trunk stability.
15906650|NCT03598088|Device|Ovaprene|non-hormonal contraceptive ring
15906651|NCT03598075|Other|Amylin (Pramlintide)|Pramlintide is a amylin analog. It will be given intravenously at the rate of 120 micrograms over 20 minutes .
15906652|NCT03598075|Other|CGRP|CGRP It will be given intravenously at the rate of 30 microgram over 20 minutes.
15906653|NCT03598049|Device|densah burs osseo densification drills|osseo densification of the alveolar bone in maxillary posterior ridge during implant placement
15906654|NCT03598049|Device|conventional surgical burs drilling|conventional implant osteotomy site drilling with implant surgical kit
15906655|NCT03598036|Drug|Voclosporin|"Voclosporin softgel capsules. Up to 10 subjects will be enrolled into Cohort 1 and take up to 3 capsules twice daily (BID).
~The dose of voclosporin for Cohort 2 (at least 10 subjects) will be determined by analysis of efficacy and safety data at Week 12 from the first 5 or 6 subjects in Cohort 1."
15906656|NCT03598023|Device|Cytal® Burn Matrix|Cytal® Burn Matrix
15906657|NCT03598023|Device|EZ-Derm® Porcine Xenograft|EZ-Derm® Porcine Xenograft
15906658|NCT03598010|Device|Actitan-F (7dd)|1 sack every 4 hours, maximum 4 sacks/day for 7 days.
15906659|NCT03598010|Device|Actitan-F (28dd)|1 sack every 4 hours, maximum 4 sacks/day for 28 days.
15906660|NCT03597997|Drug|Propofol|Target controlled infusion (TCI) with modified Marsh effect site model (Fresenius Kabi) will be used for induction and maintenance of general anaesthesia. Monitoring and other anaesthetic procedures including the management of hypertension and hypotension in group P will be the same as group S. The only difference is that induction and maintenance of general anaesthesia will be conducted using total intravenous infusion of propofol. Oxygen and air would be given to provide a FiO2 of 30-50%.
15906661|NCT03597997|Drug|Sevoflurane|Propofol 1.5-3mg/kg, remifentanil 1mcg/kg, and rocuronium 0.6-1mg/kg or atracurium 0.5mg/kg will be used intravenously for induction of general anaesthesia. Intubation would be performed after induction of general anaesthesia. General anaesthesia monitoring will be used. Sevoflurane, air and oxygen will be used for maintenance of general anaesthesia. FiO2 will be kept between 35-50%. BIS monitoring will be applied and level of anaesthetia will be titrated to maintain a BIS value of between 40-60. Intravenous remifentanil infusion between 0.1-0.2 mcg/kg/min will be given and this will be titrated to provide optimal haemodynamic parameters.
15906662|NCT03597984|Radiation|Simultaneous Integrated Boost-SIB on macroscopic metastases|"Delivery of a boost on macroscopic secondary lesion with Simultaneous Integrated Boost technique according this schedule:
~- 5 Gy x 3 fr (Whole Vertebra) + SIB 10 Gy x 3 fr on the macroscopic disease Gross Tumor Volume - (GTV)"
15906663|NCT03597971|Drug|HMPL004-6599|For each cohort, 6 subjects will receive HMPL004-6599
15906664|NCT03597971|Drug|Placebo|For each cohort, 2 subjects will receive placebo
15906668|NCT03597945|Procedure|Magnesium sulfate|Magnesium-sulfate as adjuvant to lidocaine with epinephrine in prehospital femoral nerve block for patient with diaphysial femoral fracture
15906669|NCT03597932|Device|standardized handover checklist|Following a review of relevant literatures and guidelines, a checklist consisting of the various key items necessary for giving continuing and safe intraoperative patient care was designed and validated by anesthesia residents and staff. Following 2-week to 1-month baseline data collection, each anesthesiologists and anesthesia residents in participating hospitals were asked to implement the safe-anesthesia checklist to improve practice over another 2-week to 1-month period. The checklist consists of an oral confirmation and closed-loop communication between the primary anesthesiologist and the replacement anesthesiologist. Evaluation of the effect of implementation of a standardized checklist during anesthesia care handover on patient safety during follow-up.
15906670|NCT03597919|Biological|Sabin IPV|We select one Sabin IPV product, produced by Kunming Bio institute, which is available for China's National Immunization Program in the selected study sites.
15906671|NCT03597906|Procedure|topography guided ablation|using the data obtained from the topolyzer for correction of refractive errors specially astigmatism we use 3 different treatment protocols
15906672|NCT03597906|Procedure|manifest refraction|using for ablation the exact manifest refraction
15906673|NCT03597906|Procedure|full topography modified refraction|full topography modified refraction means changing both sphere and cylinder power in the ablation profile
15906674|NCT03597906|Procedure|partial topography modified refraction|partial topography modified refraction means changing only cylinder power and axis in the ablation profile
15906675|NCT03597893|Drug|Oxytocin|intranasally administrated
15906676|NCT03597893|Drug|Placebo|intranasally administrated
15906677|NCT03597880|Other|obese patients|underwent bariatric surgery
15906678|NCT03597867|Other|Placebo|Artificial tears for 3 days preoperatively
15906679|NCT03597867|Drug|Dicloftil|Dosing of drug 3 days prior to surgery
15906680|NCT03597867|Drug|Nevanac|Dosing of drug 3 days prior to surgery
15906681|NCT03597867|Drug|Indom|Dosing of drug 3 days prior to surgery
15906682|NCT03597867|Drug|Yellox|Dosing of drug 3 days prior to surgery
15906683|NCT03597841|Drug|Combination therapy|Patients who are given combination therapy will be allocated to this group.
15906684|NCT03597815|Drug|Aflibercept 40 MG/ML [Eylea]|Intravitreal injection, form of anti-VEGF therapy
15906685|NCT03597815|Diagnostic Test|OSA diagnostic test - overnight sleep study|Overnight with specialist care in hospital - heart, lung and brain activity monitored.
15906686|NCT03597815|Device|CPAP therapy for OSA positive patients|positive airway pressure ventilator, applies mild air pressure in a continuous basis to keep the airways continuously open in patients who are able to breath spontaneously on their own.
15906687|NCT03597802|Other|Exercise at workplace - Three times per week|The exercise at workplace will be occur during the workday during the rest breaks. The exercises perform are stretching, and using load.
15906688|NCT03597802|Other|Exercise at workplace - Four times per week|The exercise at workplace will be occur during the workday during the rest breaks. The exercises perform are stretching, and using load.
15906689|NCT03597789|Behavioral|Helping the Noncompliant Child (HNC)|HNC is a mastery-based, family-focused, clinic-based treatment for young children aged 3-8 years with problem behavior.
15906690|NCT03597776|Drug|Lidocaine|Bolus of lidocaine will be given over 5 minutes before skin incision
15906691|NCT03597776|Drug|Saline|Bolus of saline will be given over 5 minutes before skin incision
15906692|NCT03597750|Device|Repose®|"Repose® Mattress
~Repose® Cushion
~Repose® Wedge or Foot Protectors"
15906693|NCT03597737|Device|Pain APP|pain app Pain Monitor app has been developed by a multidisciplinary pain expert panel, including physicians, psychologists, and nurses. Content has been validated in a previous study and usability has been shown to be excellent.
15906694|NCT03597724|Other|Questionnaire composed of 13 choice questions.|In this Discrete Choice Experiment (DCE), patients will be asked to choose which one of two hypothetical patients (Patient A and Patient B) suffering from sarcopenia with different levels of outcomes deserves the most the treatment. After completion of the choice tasks, respondents will be asked how difficult they found the choice tasks on a seven-point scale and to questions on their socio-economic and disease characteristics.
15906695|NCT03597711|Device|IVcannulation|Peripheral venous cannulation is a common procedure on neonatal NICU, especially in preterm infants
15906696|NCT03597659|Genetic|phenome-wide association study (PheWAS)|Phenome-wide association study (PheWAS) identifying clinical diagnoses associated with a polygenic predictor of TSH levels identified by a previously published genome-wide association study (GWAS) which included North American and European participants. A phenome-wide scanning of 1,318 phenotypes will be performed, using a cohort of 37,154 North American individuals of European ancestry with electronic-health-record (EHR) data.
15906697|NCT03597646|Device|Kinesio Tape|
15906698|NCT03597646|Device|Threshold Inspiratory Muscle Trainer|
15906699|NCT03597620|Drug|Metaderm|Metaderm cream and spray will be apply to subjects scalp and body.
15906700|NCT03597607|Behavioral|Intensive Smoking Cessation Group|This group will meet with the pharmacist more frequently and for longer periods than other groups.
15906701|NCT03597607|Behavioral|Abbreviated Smoking Cessation Group|This group will meet with the pharmacist less frequently and for shorter periods in comparison to the intensive group.
15906702|NCT03597594|Drug|Anti-thymocyte globulin (rabbit)|given intravenously
15906703|NCT03597594|Drug|Busulfan|given intravenously
15906704|NCT03597594|Drug|Fludarabine|given intravenously
15906705|NCT03597594|Drug|Thiotepa|given intravenous infusion
15906706|NCT03597594|Device|CliniMACS|The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells.
15906707|NCT03597594|Other|Donor Lymphocyte Infusion|given intravenous infusion
15906747|NCT03597217|Drug|PF-05221304|3, 10, 50 mg
15906748|NCT03597217|Drug|PF-05221304|50 mg multiple dose
15906711|NCT03597568|Dietary Supplement|Resveratrol|Oral supplementation for 6 weeks
15906712|NCT03597568|Other|Placebo|Oral supplementation for 6 weeks
15906713|NCT03597555|Drug|Sodium Oxybate Oral Solution 500 MG/ML|"First night after V1: Dose prescribed at 4.5 g per night (2.25 g x 2) for 2 weeks First night after V2: Dose increased to 6 g per night (3 g x 2) for 2 weeks, according to investigator's opinion, tolerance of drug and CGI-S First night after V3: Dose either maintained stable at 6 g or increased to 9 g per night (4.5 g x 2) with dose increments of 1.5 g per night (0.75 g x 2) every week, based on benefit-risk ratio, for 2 weeks.
~First night after V4: Dose maintained at 9 g or reduced at 6 g per night according to benefit-risk ratio for 2 weeks. No dose adjustment during the Maintenance period.
~First night after V5: Taper period. Dose decrease by 2.25 g x 2 every two days until complete withdrawal"
15906714|NCT03597555|Drug|Placebos|Xyrem Placebo: sodium citrate solution in equimolar concentration of sodium in the 500 mg/mL Xyrem oral solution, PH adjusted with malic acid
15906715|NCT03597542|Other|Eggs and Carbohydrates|Participants are asked to consume both egg based powder or maltodextrin dissolved in 500mL of water at two different time points at least one week apart. Participants will then submit to a venous blood draw to assess levels of cellular inflammation.
15906716|NCT03597529|Drug|Melatonin|melatonin
15906717|NCT03597516|Drug|RP-G28|powder for reconstitution for oral administration
15906718|NCT03597516|Drug|Placebos|powder for reconstitution for oral administration
15906719|NCT03597503|Drug|SPN-810|Flexible dose
15906720|NCT03597503|Drug|Placebo|Placebo
15906721|NCT03597490|Combination Product|Multimodal physical therapy with exercise|Multimodal physical therapy will compose of thermotherapy (hot pack or cold pack) and electrotherapy (transcutaneous electrical nerve stimulation or interferential current) and therapeutic ultrasound (at least two of them). Therapeutic exercise will compose of combination of range of motion, stretching, strengthening,neuromuscular and task specific exercises according to the clinical condition of patient under the supervision of a physiotherapist. Additionally, all patients will be allowed to carry on home exercise program.
15906722|NCT03597477|Drug|Dexmedetomidine|participants were randomly allocated to receive sedation with oral midazolam(0.3 mg/kg) combined with 4 doses of intranasal dexmedetomidine(1.0, 1.5, 2.0, 2.5)
15906725|NCT03597425|Procedure|Cardiopulmonary resuscitation|Cardiopulmonary resuscitation (CPR) is an emergency treatment for patients with respiratory arrest and cardiac arrest in an attempt to restore the patient to spontaneous breathing and heartbeat through cardiopulmonary resuscitation
15906726|NCT03597412|Drug|Rosuvamibe|Rosuvastatin 10mg/Ezetimibe 10mg
15906727|NCT03597412|Drug|Monorova|Rosuvastatin 20mg
15906729|NCT03597373|Other|reintubation|Reintubation was defied by the reinstitution of invasive mechanical ventilation following extubation at any time
15906730|NCT03597360|Radiation|CT scan|Participants will receive the first LDIR treatment in one session on the same day, i.e., two CT scans of the brain that delivers a total X-ray dose (CTDIvol)10 of about 80 mGy. Participants will then be transported back to Baycrest Health Sciences. Participants will receive another LDIR treatment, i.e. a single CT scan of the brain (40 mGy), 2 weeks after the first session. They will receive a third LDIR treatment, i.e., a single CT scan of the brain (40 mGy), 2 weeks after the second session. Date, time and X-ray dose will be recorded for each participant and sent to their family physician for entry into in their health record.
15906733|NCT03597334|Behavioral|aerosol therapy|Aerosol inhalation therapy refers to a local administration method in which a drug is made into aerosol particles having a very small diameter and is inhaled by a patient and the drug directly acts on the airway
15906734|NCT03597321|Biological|prophylactic donor lymphocyte infusion (DLI)|DLI will be collected from the donor by leukapheresis according to local standard procedures of each center. Cell product could be collected in one time or more, and administered fresh or after a frozen storage, according to each center's guidelines. A sufficient amount of T-cell dose should be collected to theoretically perform 3 DLI. DLI procedure will be performed according to local guidelines of each center.
15906735|NCT03597308|Drug|5mg of Oxycodone every 6 hours as needed for pain|5mg of Oxycodone every 6 hours as needed for pain
15906736|NCT03597308|Drug|600mg of Ibuprofen every 6 hours as needed for pain|600mg of Ibuprofen every 6 hours as needed for pain
15906737|NCT03597308|Drug|500mg of Acetaminophen every 6 hours as needed for pain|500mg of Acetaminophen every 6 hours as needed for pain
15906738|NCT03597295|Drug|Retifanlimab|INCMGA00012 administered at the recommended Phase 2 dose by intravenous infusion once every 28 days.
15906739|NCT03597282|Biological|NEO-PV-01|Personal Cancer Vaccine
15906740|NCT03597282|Biological|Nivolumab|monoclonal antibody against PD-1
15906741|NCT03597282|Other|Adjuvant|immune adjuvant
15906742|NCT03597282|Biological|APX005M|monoclonal agonist antibody against CD40
15906743|NCT03597282|Biological|ipilimumab|monoclonal antibody against CTLA4
15906744|NCT03597256|Device|Restylane Defyne|Intradermal injection
15906745|NCT03597243|Other|Cash Transfer|Girls enrolled receive a quarterly direct cash transfer of a total of 70,000 Tshs (30 USD) quarterly through mobile phone based cash transfer over a period of two years, for which they will receive mobile phones and SIM cards form the program.
15906746|NCT03597230|Other|Dye|Cover key details of the intervention. Must be sufficiently detailed to distinguish between arms of a study and/or among similar interventions At the beginning of the surgical procedure, 1 ml of blue patent will be injected in the normal remaining part of the pancreas. The diffusion of the dye among all lymph node areas will be noticed by the surgeon.
15906750|NCT03597204|Diagnostic Test|Fecal immunochemical test (FIT)|Annual fecal immunochemical test (FIT) for selected high risk individuals to undergo CRC screening. And colonoscopy for those with FIT positive result
15906751|NCT03597191|Other|Exercises|Participants in the treatment group will be instructed in the spinal stabilization exercises (SSEs), modeled after the spinal stabilization exercise program designed by Hicks et al. (2005). The SSE program targets muscle activation of spinal stabilizers specifically, the transversus abdominus and lumbar multifidus muscles. Each exercise will be progressed by increasing repetitions and hold time.
15906752|NCT03597178|Device|senofilcon A|ACUVUE OASYS® 1-DAY with HydraLuxe™ Technology
15906753|NCT03597165|Other|Incidental Genomic Sequencing Results|"Patient will receive GS results related to their primary indication (cancer), as well as the option to learn incidental GS results. Incidental results will be categorized into five bins based on Berg et al.'s framework (medically actionable and pharmacogenetic, common disease SNPs, Mendelian conditions, early-onset brain diseases, and carrier status). In pre-test counseling, patients will have the option to select which bins of incidental results they would like to learn, if any."
15906754|NCT03597165|Other|GS Results for Primary Indications only|Patients will receive GS results related to the primary indication (cancer) only.
15906755|NCT03597152|Dietary Supplement|WelTract|Supplement commercially available from the sponsor containing powdered extracts from Hibiscus flowers and cranberry fruit, lactoferrin, D-mannose, and vitamins C and D
15906756|NCT03597152|Dietary Supplement|Placebo|Inert placebo custom manufactured for the sponsor
15906757|NCT03597139|Drug|Voclosporin Ophthalmic Solution|Investigational Drug
15906758|NCT03597139|Drug|Restasis®|Comparator
15906759|NCT03597126|Device|Robot-assisted surgery|robot-assisted intersphincteric resection for low location rectal cancer(T=1&2)
15906760|NCT03597126|Device|Laparoscopic surgery|laparoscopic intersphincteric resection for low location rectal cancer(T=1&2)
15906761|NCT03597100|Device|Cala TWO|Wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves
15906762|NCT03597087|Procedure|Anesthesia before transurethral resection of the bladder tumor|"General anaesthesia or general anesthesia (see spelling differences) is a medically induced coma with loss of protective reflexes, resulting from the administration of one or more general anaesthetic agents.
~Spinal anaesthesia is a form of regional anaesthesia involving the injection of a local anaesthetic into the subarachnoid space, generally through a fine needle"
15906763|NCT03597087|Drug|Anesthesia|"General anaesthesia : propopol
~Spinal anaesthesia : bupibacaine"
15906764|NCT03597074|Diagnostic Test|color Doppler Ultrasound derived RI and semi-quantitative evaluation of intra-renal vascularization|Use of color Doppler Ultrasound derived Renal Resistive Index (RI) and semi-quantitative evaluation of intra-renal vascularization for early prognosis of AKI progression
15906765|NCT03597061|Behavioral|Healthy Start to Feeding|The intervention provides parent education and skills training on a responsive feeding approach to introduction of healthy foods in infancy. Session content is manualized and administered by interventionists with expertise in child development and behavioral strategies for managing child eating behaviors under the supervision of a licensed clinical child psychologist and pediatric occupational therapist. Sessions are conducted individually with participants and primary caregivers and include educational content, handouts and instructions, modeling of skills by the interventionist, caregiver practicing of skills in session, establishment of behavioral goals, and problem solving barriers to implementation of treatment content. Content will include topics such as allowing infants' own hunger and satiety cues to guide the feeding experience, introducing healthy foods, parental attunement to infant satiety cues, and promoting infants' own self-feeding.
15906766|NCT03597048|Behavioral|Curriculum|The curriculum intervention is a three- module, three-hour curriculum delivered by teachers in sixth grade classrooms over a three- to six-day period. The curriculum is designed to increase knowledge and improve attitudes about mental illnesses so as to improve the school climate with respect to mental illness stigma and encourage help seeking for youth in need.
15906767|NCT03597048|Behavioral|Contact|The contact intervention involves two college students-a 27-year-old male with a history of bipolar I disorder and a 24-year-old female with a history of bipolar II disorder-who each make a ten-minute in-class presentation (20 minutes total) describing onset and course of their symptoms, hospitalizations and treatments, their feelings about the illness, coping strategies, and impact of the illness on social relationships and functioning at school and work.
15906768|NCT03597048|Behavioral|Materials|"The materials intervention is implemented by teachers who prominently display posters in the classroom for two weeks and provide students with bookmarks. The materials focus on individuals' with mental illnesses emphasizing their personal traits and abilities as opposed to language that labels a person as mentally ill."
15906769|NCT03597035|Drug|Spironolactone|The study participants will receive concomitant treatment with Veltassa 8.4 grams per day and Spironolactone 25 mg per day or maximum tolerated dose. If dictated by the potassium level, Veltassa can be increased to 16.8 grams per day.
15906770|NCT03597022|Drug|Befovacimab (BAY1093884)|Once weekly doses until premature termination of the study, subcutaneous injection
15906771|NCT03597009|Drug|Talimogene laherparepvec (TVEC)|Talimogene laherparepvec (TVEC) (4ml of 108 pfu/ml) for up to 9 cycles, with or without nivolumab
15906772|NCT03597009|Drug|Nivolumab|Nivolumab (240 mg IV) will be co-administered with talimogene laherparepvec (TVEC) (4ml of 108 pfu/ml) for up to 9 cycles in the Dose Level 2 cohort
15906773|NCT03596996|Dietary Supplement|Ferrous Sulfate|Ferrous sulfate dosed by WHO guidelines by age for the prevention of iron deficiency and anemia.
15906774|NCT03596996|Dietary Supplement|Placebo|Placebo with identical appearance comparison intervention arm
15906775|NCT03596983|Behavioral|Sleep Intervention|"Sleep Diaries (Daily)
~Fitbit 24/7
~Phone/ video conference calls (weekly with study team)
~Epworth Sleepiness Scale (weekly)
~PROMIS fatigue scale-evening (weekly)"
15906776|NCT03596983|Behavioral|Week 2 Intervention|"Sleep Diaries (Daily)
~Phone Calls (weekly with study team)
~Wrist Accelerometry and fitbit 24/7 for 14 days
~SAFTEE Questionnaire
~ASA24
~Behavioral risk factor surveillance system (smoking and alcohol use questions)
~Psychological well-being (SF36)
~Index of Self Regulation
~PROMIS fatigue scale-morning (weekly)
~PROMIS fatigue scale-evening (weekly)
~Epworth Sleepiness Scale (weekly)"
15906777|NCT03596970|Drug|TAC withdrawal|Everolimus (RAD001) with MMF and Steroids
15907562|NCT03591172|Drug|saline|Using saline as a final irrigation in revasculariztion
15906778|NCT03596970|Drug|Everolimus with reduced TAC|Active comparator arm: Everolimus (RAD001) with reduced TAC and Steroids
15906779|NCT03596957|Drug|Tolvaptan|At baseline the tolvaptan dosing will start with daily morning and afternoon doses of 45 mg and 15 mg respectively, with weekly increases to 60 mg and 30 mg and then to 90 mg and 30 mg according to subject tolerability
15906780|NCT03596944|Drug|Statin|Prescribed with statins for primary prevention
15906781|NCT03596931|Drug|Statins (Cardiovascular Agents)|Prescribed with statins
15906782|NCT03596918|Biological|Bleomycin Sulfate|Given IV
15906783|NCT03596918|Other|Laboratory Biomarker Analysis|Correlative studies
15906784|NCT03596918|Other|Quality-of-Life Assessment|Ancillary studies
15906785|NCT03596918|Other|Questionnaire Administration|Ancillary studies
15906786|NCT03596918|Drug|Vincristine Sulfate|Given IV
15906787|NCT03596905|Drug|Plecanatide|Taken orally daily for 4 weeks
15906788|NCT03596905|Drug|Matching placebo|Taken orally daily for 4 weeks
15906789|NCT03596892|Drug|Decitabine|Decitabine was administered at 20mg/m2/day on days -14 and -10.
15906790|NCT03596892|Drug|Busulfan (BU)|Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.
15906791|NCT03596892|Drug|Cyclophosphamide (CY)|Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
15906792|NCT03596879|Behavioral|dCBTI|Online access to the digital CBTI program Sleepio based off of traditional face-to-face Cognitive Behavioral Therapy, six weekly sessions done online.
15906793|NCT03596879|Behavioral|Sleep Education|Six weekly email messages with sleep hygiene recommendations. Subjects are encouraged to read through the information and apply it to their sleep.
15906796|NCT03596853|Other|Progressive mobilization|"Will be applied once a day, 5x/ week, performed into 4 levels: N1 (bridge and rolling for both sides); N2 (transfer training from lying down to sitting on both sides); N3 (sit and stand up from a chair); N4 (running training). According to their functional level, patients will perform, once a day, 8 sets of each movement, alternating 20 seconds of execution with 10 seconds of rest. Patients will be stimulated constantly to perform the movements with the highest possible speed.
~If the patient performs adequately within of your level functional level, can will progress in level, if can not progress, there will be an increase in training volume within the level itself. Adequate performance within the functional level means that the patient is able to complete more than eight sets of exercise and does not present increased sensation of pain, present sensation of perceived exertion within the safety limit of the protocol (Borg ≤ 6)."
15906797|NCT03596853|Other|Usual Care|This group will receive standard usual, which will be monitored, but not protocolised.
15906798|NCT03596827|Biological|E. coli strain E1392-75-2A dose 1E10 CFU|Diarrhoeagenic E. coli strain E1392/75-2A serotype O6:H16 belongs to Pathogen class 2 . The strain has a deletion of genes encoding the heat-labile (LT) and heat-stable (ST) toxins and can not produce any toxins. However, it continues to express Colonization Factor Antigen II (CFA/II) and provides 75% protection against challenge with an LT, ST, CFA/II strain
15906799|NCT03596827|Biological|E. coli strain E1392-75-2A dose 1E9 CFU|Diarrhoeagenic E. coli strain E1392/75-2A serotype O6:H16 belongs to Pathogen class 2 . The strain has a deletion of genes encoding the heat-labile (LT) and heat-stable (ST) toxins and can not produce any toxins. However, it continues to express Colonization Factor Antigen II (CFA/II) and provides 75% protection against challenge with an LT, ST, CFA/II strain
15906800|NCT03596827|Biological|E. coli strain E1392-75-2A dose 1E8 CFU|Diarrhoeagenic E. coli strain E1392/75-2A serotype O6:H16 belongs to Pathogen class 2 . The strain has a deletion of genes encoding the heat-labile (LT) and heat-stable (ST) toxins and can not produce any toxins. However, it continues to express Colonization Factor Antigen II (CFA/II) and provides 75% protection against challenge with an LT, ST, CFA/II strain
15906801|NCT03596827|Biological|E. coli strain E1392-75-2A dose 1E7 CFU|Diarrhoeagenic E. coli strain E1392/75-2A serotype O6:H16 belongs to Pathogen class 2 . The strain has a deletion of genes encoding the heat-labile (LT) and heat-stable (ST) toxins and can not produce any toxins. However, it continues to express Colonizat
15906802|NCT03596827|Biological|E. coli strain E1392-75-2A dose 1E6 CFU|Diarrhoeagenic E. coli strain E1392/75-2A serotype O6:H16 belongs to Pathogen class 2 . The strain has a deletion of genes encoding the heat-labile (LT) and heat-stable (ST) toxins and can not produce any toxins. However, it continues to express Colonizat
15906803|NCT03596814|Other|No Interventional study|Retrospective data
15906804|NCT03596801|Biological|RSV 6120/∆NS1|Delivered as nose drops
15906805|NCT03596801|Biological|RSV 6120/F1/G2/∆NS1|Delivered as nose drops
15906806|NCT03596801|Biological|Placebo|Delivered as nose drops
15906807|NCT03596788|Dietary Supplement|Carbohydrate Beverage|The carbohydrate beverage will supply approximately 100 grams of carbohydrate per day (in the form of glucose and fructose)
15906808|NCT03596788|Dietary Supplement|Placebo Beverage|The placebo beverage will contain aspartame.
15906809|NCT03596775|Drug|Dexmedetomidine|Children in Dexmedetomidine group receive intravenous dexmedetomidine 0.5 ug/kg over 10 minutes after induction of anesthesia.
15906810|NCT03596775|Drug|saline|Children in Control Comparator group receive intravenous saline 10ml over 10 minutes after induction of anesthesia.
15906811|NCT03596762|Drug|BAY3427080|BAY3427080 capsules
15906812|NCT03596762|Drug|Placebo|Placebo capsules
15906813|NCT03596749|Drug|Sevelamer Carbonate|Sevelamer carbonate 1600mg (p.o. b.i.d) with meals
15906814|NCT03596736|Procedure|Elbow Hemiarthroplasty|
15906815|NCT03596736|Procedure|Total Elbow Arthroplasty|
15906816|NCT03596723|Drug|KPI-121 1%|eye drops
15906817|NCT03596723|Drug|Prednisolone acetate|eye drops
15906818|NCT03596710|Procedure|Image Guided Biopsy|Undergo image guided biopsy
15906819|NCT03596697|Drug|CRV431|Single or multiple dose(s) of CRV431
15906820|NCT03596697|Drug|Placebo|Single Placebo dose
15906821|NCT03596697|Drug|TDF|Single or multiple dose(s) of TDF
15906822|NCT03596684|Dietary Supplement|citrulline supplementation|2.5 g per os of citrulline on the morning and the evening (5 g/ jour) during 4 weeks.
15906823|NCT03596684|Dietary Supplement|placebo supplementation|2.5 g of the product in the morning and in the evening during 4 weeks.
15936662|NCT03367923|Other|Quality-of-Life Assessment|Ancillary studies
15906824|NCT03596684|Procedure|glucose tolerance test|2 exploration mornings distant from 28 days (before and after citrulline) will allow carrying out an oral glucose tolerance test of 2 hours (75 g glucose per os)
15906825|NCT03596671|Device|RENOVA iStim™ System|Tibial implantable neuromodulation device
15906826|NCT03596658|Drug|SHR9549|If initial dosing of SHR9549 is tolerated then subsequent cohorts will test increasing doses until a maximum tolerated dose(MTD) is defined
15906829|NCT03596632|Drug|Fenebrutinib|200-mg (100 µCi) oral solution 14C/12C]-fenebrutinib
15906830|NCT03596619|Device|PBN|The PBN-ALA-PDT group underwent vertical skin tapping with PBN before applying 10% ALA cream and narrow-band light-emitting diode (LED) irradiation (mean 633 nm, with a standard deviation [SD] of 10 nm; 100-200 J/cm2). The ALA-PDT group received ALA cream and irradiation only.
15906831|NCT03596606|Procedure|Osteopathic Treatment|"The Osteopathic treatment will be adapted to each patient at the discretion of the therapist, being able to select all or part of the following osteopathic techniques in each session.
~Soft tissue techniques.
~Articulatory techniques applied at cervical level
~Osteopathic manipulation techniques applied at the affected jaw/s.
~Functional Indirect technique at the level of the affected jaw/s: For Type I or II diagnosis."
15906832|NCT03596606|Procedure|Myofunctional Motor control exercises|"The protocol is a set of 8 exercises to improve the execution of the function in the stomatognathic and cervical area.
~The therapist explains the objectives of the exercises and the patient performs it after each session and at home three times a day.
~The first day before performing the myofunctional exercises, will be an explanatory talk prior to the exercises in order to educate the patient. The second day, before doing the exercises, will review the concept of memory of pain and the benefits of doing the exercises"
15906833|NCT03596593|Diagnostic Test|SPANOM (identifying MSI status from ctDNA)|SPANOM technique, which has been developed by 3D Medicines Inc. Shanghai, China and made it possible to identify MSI status from blood samples, will be used in patients with refractory advanced solid tumors.
15906834|NCT03596567|Drug|Glasdegib single 100 mg dose in normal healthy subjects|A single dose of 100 mg glasdegib tablet will be administered after an overnight fast, followed by serial PK collection, discharge and follow -up.
15906835|NCT03596567|Drug|Glasdegib single 100 mg dose in moderate renal impairment subjects|A single dose of 100 mg glasdegib tablet will be administered to subjects with moderate renal impairment, after an overnight fast, followed by serial PK collection, discharge and follow -up.
15906836|NCT03596567|Drug|Glasdegib single 100 mg dose in severe renal impairment subjects|A single dose of 100 mg glasdegib tablet will be administered to subjects with severe renal impairment, after an overnight fast, followed by serial PK collection, discharge and follow -up.
15906837|NCT03596554|Other|Descriptive study|Description of the circulating values of Fibroblast Growth Factor 21 in X-linked hypophosphatemia children compared to controls in the VITADOS cohort (healthy children and adolescents aged 10-18 years), after age-matched, pubertal stage and sex).
15906838|NCT03596541|Device|Heart and Respiratory Auscultation of an open real-time tele-stethoscopy system (EHAS-Fundatel digital stethoscope)|We compare the respiratory and heart auscultation of clinicians using the EHAS-Fundatel digital stethoscope and a conventional stethoscope and we will observe; inter-observer and intra-observer differences by two auscultation methods.
15906839|NCT03596528|Procedure|Lung biopsy|Each patient will be brought to the operating room and will undergo cryobiopsy and surgical biopsy of the lung sequentially in the same surgical stage.
15906840|NCT03596515|Other|Sensory Integration|Sensory Integration (SI) is a theory and framework conceptualized by Dr. Jean Ayres, a highly experienced occupational therapist, with its main objective as enhancing the brain's capacity to perceive and organize sensory information to produce a more normal, adaptive response; thus, to provide the foundation for mastering academic tasks.
15906841|NCT03596502|Drug|Direct oral anticoagulants (DOACs)|Exposure to DOACs will be defined as a new prescription for apixaban (ATC B01AF02), dabigatran (ATC B01AE07), or rivaroxaban (ATC B01AF01) at cohort entry date in patients diagnosed with non-valvular atrial fibrillation.
15906842|NCT03596502|Drug|Warfarin|Exposure to warfarin will be defined as a new prescription for warfarin (ATC B01AA03) at cohort entry date in patients diagnosed with non-valvular atrial fibrillation.
15906843|NCT03596476|Procedure|Upper gastrointestinal (GI) endoscopy|An upper gastrointestinal (GI) endoscopy will be performed at V1. Four esophageal biopsies will be taken in both the proximal and the distal esophagus.
15906844|NCT03596476|Procedure|Wireless pH monitoring|Wireless pH monitoring will be performed at V1. The pH capsule will be clipped into the esophagus during the upper GI endoscopy. The esophageal pH will be recorded for 96 hours (ambulatory recording).
15906845|NCT03596476|Procedure|Post prandial esophageal High Resolution Impedance Manometry|Post prandial esophageal HRIM will be performed at V2. The recording will be started after transnasal insertion of the HRIM probe. A standardized meal will be given to the patient (Big Mac, medium portion of French fries, orange juice). The recording will be realized for one hour after the end of the meal.
15906846|NCT03596476|Procedure|pH-impedance monitoring|24-h pH-impedance monitoring on PPI will be performed at V3. A transnasal catheter will be inserted into the esophagus and the recording will be performed for 24 hours (ambulatory recording).
15906847|NCT03596463|Other|Breast cancer treatment|Multidisciplinary approach for breast cancer treatment is more beneficial for the patients
15906892|NCT03596112|Other|application of a polyacrylate wound pad|A sterile polyacrylate wound pad with activated carbon cloth treatment will be applied to chronic wounds in an outpatient clinic from a specialist nurse
15906850|NCT03596437|Device|Ultra High Frequency ultrasound system|Agreement for carotid intima-media thickness in vascular Ehlers Danlos Syndrome and for triple signal identification in fibromuscular dysplasia will be assessed.
15906851|NCT03596424|Drug|Ketamine Hydrochloride|Intraoperative bolus and infusion (see arm description)
15906852|NCT03596424|Drug|Dexmedetomidine Hydrochloride|Intraoperative bolus and infusion (see arm description)
15906853|NCT03596424|Combination Product|dexmedetomidine Hydrochloride and Ketamine Hydrochloride|Intraoperative bolus and infusion (see arm description)
15906854|NCT03596398|Genetic|GLA gene|Genetic test will be performed when enzyme activity is found abnormal in the whole blood test or confirmation is required. 5 ml of blood sample will be obtained and polymerase chain reaction (PCR) sequencing will be executed to determine mutations in the GLA gene.
15906855|NCT03596385|Drug|Beta blocker|long-term maintenance beta-blocker therapy
15906856|NCT03596372|Drug|BAY1834942|"Dose escalation:
~Sequential dose levels
~.
~Dose expansion (except for low-dose expansion):
~With maximum tolerated dose (MTD) identified in dose escalation part."
15906857|NCT03596359|Behavioral|Education with Teach-Back method|
15906858|NCT03596359|Other|Received routine treatment|
15906859|NCT03596346|Other|Rapeseed ingredient (RI)|2 snack bars daily containing 10 g of RI each.
15906860|NCT03596346|Other|Control product without added RI|2 snack bars daily containing 0 g of RI.
15906861|NCT03596333|Other|Retrospective chart review|We conducted a retrospective chart review to evaluate the stored ultrasound images used during labor epidural placement, as well as demographic and anesthetic variables.
15906862|NCT03596320|Procedure|colonoscopy|description of the results of colonoscopy im managment of children with rectal bleeding
15906863|NCT03596307|Dietary Supplement|Ashwagandha extract|Shoden 180 mg capsule.
15906864|NCT03596307|Dietary Supplement|Placebo|Placebo 180 mg (Sucrose) capsule.
15906865|NCT03596294|Drug|Clazosentan|Continuous i.v. infusion of 15 mg/h of clazosentan for 3 h
15906866|NCT03596294|Drug|Rifampicin|Single i.v. dose of 600 mg rifampicin for 30 min
15906867|NCT03596294|Other|Saline (0.9% sodium chloride)|Single i.v infusion of 500 mL saline for 30 min
15906868|NCT03596281|Drug|Pembrolizumab|200mg Q3W IV
15906869|NCT03596281|Drug|Bevacizumab|400 or 300 mg Q3W IV
15906870|NCT03596281|Drug|pegylated liposomal doxorubicin (PLD)|15 or 20 or 30 mg/m² Q3W IV
15906871|NCT03596268|Diagnostic Test|Imaging|3T Prisma MRI
15906872|NCT03596268|Diagnostic Test|Serum Laboratory Tests|Blood (plasma and cellular) will be collected.
15906873|NCT03596268|Diagnostic Test|Lumbar Puncture|CSF will be collected
15906874|NCT03596255|Diagnostic Test|Estimated level of DA|the dental personnel estimated the patient's level of DA (eDA) on a 100mm VAS
15906875|NCT03596255|Diagnostic Test|MDAS|The patient rated their DA using the Modified Dental Anxiety Scale (MDAS)
15906876|NCT03596242|Other|SMS System|Participants will receive usual care +SMS texting and phone calls to monitor their blood pressure and medication adherence
15906877|NCT03596242|Behavioral|blood pressure control education|standard blood pressure control education given during visits
15906878|NCT03596216|Other|PENS|This intervention consisted in the application of an asymmetric biphasic rectangular current of 150 microseconds and 10 Hz using a specifically developed medically certified device (Physio Invasive, Enraf Nonius, Prim, SPAIN). This is an invasive intervention by ultrasound and needles.
15906879|NCT03596216|Other|TENS|This intervention consisted in the application of an asymmetric biphasic rectangular current of 150 microseconds and 10 Hz using a specifically developed medically certified device (Physio Invasive, Enraf Nonius, Prim, SPAIN). This is a non-invasive intervention by self-adhesive electrodes.
15906880|NCT03596203|Device|TransCutaneous Magnetic Stimulator (TCMS)|TCMS coils which are connected to feet and pulse generator. The generator will then be turned on to deliver 50 pulses at a pulse period of 6 seconds and at a pulse intensity of 100% to the bottom of the foot with the TCMS coil.
15906881|NCT03596190|Diagnostic Test|ultrasonographic diaphragmatic assessment|"Diaphragmatic dysfunction will be determined by intercostal diaphragm thickening. The available image will be saved.
~Diaphragmatic motion assessments will be conducted on the side to be blocked both at baseline, and then every 5 minutes until patient leaves for operating room or 30 minutes (whatever is earlier)."
15906882|NCT03596177|Drug|MEDI0382|MEDI0382 will be administered subcutaneously, titrated up to 300 μg for 42 days (100 μg for 4 days, followed by 200 μg for 4 days, and finally 300 μg for 34 days) in double-blind treatment period.
15906883|NCT03596177|Drug|Placebo|Placebo will be administered subcutaneously for 16 days in the single-blind treatment period in both MEDI0382 and placebo arms, and SC injection of placebo matched to MEDI0382 for 42 days in double-blind treatment period in placebo arm.
15906884|NCT03596164|Drug|Teduglutide|Teduglutide 0.05 mg/kg SC injection will be administered once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm.
15906885|NCT03596164|Device|Syringe|Teduglutide will be administered using syringe. Syringe is approved for use in Japan by PMDA.
15906886|NCT03596164|Device|Needle|Teduglutide will be administered using needle. Needle is approved for use in Japan by PMDA.
15906887|NCT03596164|Device|Vial Adapter for Device|Vial adapter for device is approved for use in Japan by PMDA.
15906888|NCT03596151|Device|Click Device|A single-use device containing a polymerase chain reaction (PCR)-based nucleic acid amplification test (NAAT) for detection of deoxyribonucleic acid (DNA) from Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV) in self-collected vaginal specimens.
15906889|NCT03596138|Other|Evaluate the reliability and reproductibility of the automated angular measurement by the Gazelab|Compare the results of the Gazelab to the alternate occlusion by prism bar (standard gold) examiners.
15906890|NCT03596125|Drug|N-acetylcysteine|N-acetylcysteine supplementation
15906891|NCT03596125|Drug|Placebo|per os: jelly tablets Intravenous Route: Glucidion G5
15907563|NCT03591159|Other|Membran Sweeping|Cervical Membrane Sweeping by digital examination
15906893|NCT03596112|Other|Hydrocellular foam|Active Comparator: hydrocellular foam pad serile hydrocellular standard foam pad will be applied to chronic wounds in an outpatient clinic from a specialist nurse
15906894|NCT03596099|Dietary Supplement|Mizkan rice vinegar with acetic acid|200mL serving of a fruit-flavored beverage containing diluted Mizkan rice vinegar and 750mg acetic acid.
15906895|NCT03596099|Dietary Supplement|Mizkan rice vinegar without acetic acid|200mL serving of a fruit-flavored beverage containing diluted Mizkan rice vinegar that has undergone a freeze-drying process to remove the acetic acid
15906896|NCT03596086|Drug|ADV/HSV-tk (gene therapy)|The investigational adenovirus gene therapy injected at tumor site followed by valacyclovir, radiotherapy, and chemotherapy
15906897|NCT03596073|Drug|Topical Calcipotriene Ointment|Calcipotriene is a form of vitamin D. It works by slowing down the growth of skin cells.
15906898|NCT03596073|Other|Topical Vaseline|Placebo
15906899|NCT03596060|Drug|Fentanyl|Fentanyl will be used for introduction in both regional and general anesthesia. It will also be used for general anesthesia maintenance.
15906900|NCT03596060|Drug|Propofol|Propofol will be used for introduction in general anesthesia.
15906901|NCT03596060|Drug|Rocuronium|Rocuronium will be used for introduction in general anesthesia.
15906902|NCT03596060|Drug|Chirochaine|Chirochaine 0.5% will be used in regional anesthesia.
15906903|NCT03596060|Drug|Morphine|Morphine will be administered bolus iv in General anesthesia group postoperatively before patients leave OR.
15906904|NCT03596047|Device|Radial wave therapy|6 radial waves' sessions. A weekly session of radio waves will be applied with the following parameters: 6000 pulses at 1.5-2.6 bar (depending on patient tolerance), with a frequency of 12Hz, the frequency should increase to 17HZ the first 500 impulses to create mild anesthesia in the area; in all the sessions of radial waves, 4000 impulses will be distributed in the body of the penis in scanning technique and 2000 impulses in the perineal area, specifically in the ischiocavernosus and bilateral bulbo-sponge muscles. During the period of therapy application, patients will receive oral treatment with sildenafil according to the patient's degree of affectation.
15906905|NCT03596047|Device|Placebo therapy|"There will be a weekly session of placebo wave therapy, using the respective device to prevent the patient from receiving the radial wave. The same parameters of the real therapy will be used: 6000 pulses at 2.6 bar, with a frequency of 17 Hz; in all the sessions of radial waves, 4000 impulses will be distributed in the body of the penis in scanning technique and 2000 impulses in the perineal area. During the period of therapy application, patients will receive oral treatment with sildenafil according to the patient's degree of affectation."
15906906|NCT03596034|Other|JUUL 5%, Virginia Tobacco, ENDS product|Subjects participate in a 15 day product use period during which subjects will be requested to predominantly use the JUUL 5% product ad libitum as their primary source of nicotine. Subjects will be asked to report their daily use of the JUUL 5% product and CPD throughout the 15 day product use period.
15906907|NCT03596008|Dietary Supplement|Active drink|The freeze-dried strawberry powder (25 g) in active drink
15906908|NCT03596008|Dietary Supplement|Placebo drink|Placebo drink
15906909|NCT03595995|Biological|UB-621|Monoclonal antibody by SC injection
15906910|NCT03595995|Other|Placebo|The placebo is a sterile, clear and colorless or slightly yellow liquid, contains the same composition as UB-621 except drug substance. It is given by SC injection.
15906911|NCT03595982|Drug|Procardia XL 30Mg|Procardia XL 30 mg XL Q 12h
15906912|NCT03595982|Drug|Procardia XL 60Mg|Procardia XL 60 mg Q 24h
15906913|NCT03595969|Diagnostic Test|Relative copy number of mitochondrial DNA|Mitochondria are responsible for multiple cellular functions including regulation of energy production, modulation of oxidation-reduction status, generation of reactive oxygen species and apoptosis. Each mitochondrion possesses multiple copies of a mitochondrial genome comprised of independently replicating double stranded DNA (mtDNA).
15906914|NCT03595956|Other|Medical gender affirmation|The intervention to be evaluated is medical gender affirmation delivered in primary care (medical gender affirmation: hormones and/or surgery vs none).
15906915|NCT03595943|Dietary Supplement|Low glycemic index, pulse-based diet|Diet that includes pulses (i.e. meals that contain chickpeas, lentils, beans, or peas)
15906916|NCT03595943|Dietary Supplement|Moderate glycemic index hospital diet|Diet that is derived from a regular hospital menu for patients
15906917|NCT03595930|Drug|Arnuity|ARNUITY consist of Fluticasone Furoate, is an Inhaled corticosteroids (ICS) medicine taken as one inhalation, once daily, for the control and prevention of asthma in adults and children aged 12 years and older.
15906918|NCT03595917|Drug|ABL001|•ABL001 is administered daily per 28 day cycle
15906919|NCT03595917|Drug|Dasatinib|Fixed doses oral once a day per 28 day cycle
15906920|NCT03595917|Drug|Prednisone|Fixed doses oral once a day per 28 day cycle Prednisone will be tapered and stop during cycle 2.
15906921|NCT03595904|Behavioral|E-Motivate group|Participants in the e-Motivate group will receive standard clinical care which includes patient navigation (e.g., scheduling and reminders). They will also complete a 20-minute, motivational interviewing informed tablet app in the clinic immediately after they receive a referral for a screening colonoscopy. The tablet app consists of educational videos, interactive exercises (e.g., decisional balance), and personalized feedback (e.g., print summary).
15906922|NCT03595904|Behavioral|Usual Care Group|Participants in the usual care group will receive standard clinical care for patients referred for a screening colonoscopy. In particular, they will receive patient navigation which includes scheduling the colonoscopy appointment, making reminder calls, and providing print materials regarding the bowel prep instructions.
15906923|NCT03595891|Other|Non-Interventional|Non-Interventional
15906924|NCT03595878|Radiation|Parotid sparing WBRT|Whole Brain Radiation Therapy with avoidance of the parotid glands
15906925|NCT03595878|Radiation|Standard WBRT|Standard Whole Brain Radiation Therapy
15906926|NCT03595865|Drug|tafluprostin|Both patients in PACG and POAG groups will dose 1 time daily in each eye for 6months. Each eye will be preformed tafluprostin 0.0015% at 9 PM.
15906927|NCT03595852|Drug|Cefazolin|Cefazolin will be given to patients in the experimental arm prophylactically prior to surgery
15906928|NCT03595852|Drug|Placebos|IV normal saline will be given to patients 30-60 minutes prior to incision
15906929|NCT03595839|Procedure|Fistulotomy|The fistula track is laid open after complete probing till the internal opening
15936663|NCT03367923|Other|Questionnaire Administration|Ancillary studies
15906930|NCT03595839|Procedure|Marsupialization|The laid open track will be marsupialized using interrupted absorbable sutures
15906931|NCT03595826|Drug|Neurostimulant pharmaceutical drugs|The Pi will only administer the exercise intervention. This will consist of minimum of 8 sessions of group exercises, working on improving muscle tone, core stability, balance, fine and gross motor skills and visual motor integration. The pharmacological therapy will be administered and monitored by medical practitioners, as is the norm with most children diagnosed and treated for ADHD/ADD. Parents of participants will remain responsible entirely for the monitoring of the pharmacological therapy of their children.
15906932|NCT03595813|Procedure|Blood sample collection|Blood samples collection (5EDTA vials) at baseline, post infusion of ICB n°2/4/8 and at progression
15906933|NCT03595813|Procedure|Biopsy collection|Optional biopsy collection at baseline and progression
15906934|NCT03595800|Procedure|Hematopoietic stem cells transplantation|Allogeneic Hematopoietic stem cells transplantation
15906935|NCT03595787|Procedure|Coaching and Habilitation|nutritional support, adapted physical activity and coaching
15906936|NCT03595774|Dietary Supplement|Beet root juice|Beet root juice
15906937|NCT03595748|Behavioral|Peer mentorship|Participants randomized to this arm of the study will speak with their dialysis peer mentor once a week about fluid intake and adherence to dialysis.
15906938|NCT03595735|Device|Zenflow Spring System|The Zenflow Spring System consists of the Spring Delivery System with Implant, Spring Scope, Camera Control Unit (CCU), Measurement Tool, and Spring Retrieval Tool.
15906939|NCT03595722|Device|High Intensity Focused Ultrasound|High intensity focused ultrasound to rectal/pelvic cancer
15906940|NCT03595709|Drug|3-in-1 tablet (EFV 400mg, TDF 300mg, 3TC 300mg)|All eligible subjects will receive 3-in-1 tablet (EFV 400mg, TDF 300mg, 3TC 300mg) once daily for 24 weeks orally on empty stomach before bedtime. If the event of toxicity or tolerability issues requires a change from study drug, switching to the best available treatment will be recommended.
15906941|NCT03595696|Other|Core Muscle Strength Training|Targeted weekly workouts consisting of low-impact aerobic exercises and resistance exercises designed to address muscle imbalance common in women who exhibit DRA and to prompt automatic core engagement while performing compound, multi-joint movements.
15906942|NCT03595683|Drug|Pembrolizumab|200 mg given by intravenous (IV) infusion once every 3 weeks.
15906943|NCT03595683|Biological|EDP1503|Taken by mouth twice daily. Each capsule will contain ≥ 7.5x10^10 colony-forming units (CFU).
15906944|NCT03595670|Other|standardized questionnaires|standardized questionnaires concerning the perception
15906945|NCT03595670|Other|interview|Semi-directive interviews will be conducted. The purpose of this approach is to question the meaning of the disease (beliefs, representations), the psycho-social management of the disease, its inscription in the socio-cultural condition of the patients.
15906946|NCT03595657|Biological|CS1001|monoclonal antibody
15906947|NCT03595644|Radiation|SBRT+TKI|Received SBRT after three months after EGFR-TKI treatment
15906948|NCT03595644|Drug|TKI|Received EGFR-TKI treatment
15906949|NCT03595631|Other|Physical Therapy|Patients will receive 5 session of multimodal physiotherapy treatment of 30min duration including low-load strength exercises, soft tissue mobilization and muscle-tendon stretching exercises twice per week.
15906950|NCT03595631|Other|Physical Therapy plus Neurodynamic|Patients will receive 5 session of multimodal physiotherapy treatment of 30min duration including low-load strength exercises, soft tissue mobilization and muscle-tendon stretching exercises twice per week. In addition, they will also receive bilateral nerve slider neurodynamic interventions targeting the median, ulnar and radial nerves.
15906951|NCT03595618|Drug|GLPG1972|Film-coated tablets of GLPG1972 for oral use.
15906952|NCT03595618|Drug|Placebo|Film-coated tablets of matching placebo for oral use.
15906953|NCT03595605|Behavioral|Ambulation|This group will be encouraged twice daily to ambulate
15906954|NCT03595605|Other|Standard of Care|Care as usual at inpatient NYU Langone
15906955|NCT03595592|Drug|Trastuzumab|Trastuzumab will be given i.v. on day 1 every 3 weeks in arms HPCT, ACy followed by HPCT and atezolizumab and in arm HPCT and atezolizumab
15906956|NCT03595592|Drug|Pertuzumab|Pertuzumab will be given i.v. on day 1 every 3 weeks in arms HPCT, ACy followed by HPCT and atezolizumab and in arm HPCT and atezolizumab
15906957|NCT03595592|Drug|Carboplatin|Carboplatin will be given i.v. on day 1 and day 8 every 3 weeks in arms HPCT, ACy followed by HPCT and atezolizumab and in arm HPCT and atezolizumab
15906958|NCT03595592|Drug|Paclitaxel|Paclitaxel will be given i.v. on day 1 and day 8 every 3 weeks in arms HPCT, ACy followed by HPCT and atezolizumab and in arm HPCT and atezolizumab
15906959|NCT03595592|Drug|Doxorubicin|Adriamycin will be delivered i.v. on day 1 every 3 weeks in arm ACy followed by HPCT for the first 3 cycles
15906960|NCT03595592|Drug|Cyclophosphamide|Cyclophosphamide will be given i.v. on day 1 every 3 weeks in arm ACy followed by HPCT and atezolizumab for the first 3 cycles
15906961|NCT03595592|Drug|Atezolizumab|Atezolizumab will be given i.v. on day 1 every 3 weeks in arm ACy followed by HPCT and atezolizumab and in arm HPCT and atezolizumab
15906962|NCT03595592|Procedure|Surgery|Breast cancer surgery (breast and axilla) either conservative or radical not later than 4 weeks from the last dose of neoadjuvant therapy in all study arms
15906963|NCT03595579|Drug|AXS-05|AXS-05 taken twice daily for 6 weeks.
15906964|NCT03595579|Drug|Bupropion|Bupropion taken twice daily for 6 weeks.
15906965|NCT03595566|Drug|ridinilazole|ridinilazole 200mg bid
15906966|NCT03595566|Drug|vancomycin|vancomycin 125mg qid
15906967|NCT03595553|Drug|ridinilazole|ridinilazole (200 mg bid)
15906968|NCT03595553|Drug|vancomycin|vancomycin (125 mg qid)
15906969|NCT03595540|Other|Prolon|Prolon by L-Nutra is a medically-designed dietary kit providing the food to eat for five days. Day 1 of Prolon provides ~4600 kJ (11% protein, 46% fat, and 43% carbohydrate), whereas days 2-to-5 provide ~3000 kJ (9% protein, 44% fat, and 47% carbohydrate) per day.
15906970|NCT03595527|Diagnostic Test|HIV and HCV screening|HIV test: ARCHITECT HIV Ag/Ab Combo, Abbott HCV test: ARCHITECT Anti-HCV, Abbott
15906971|NCT03595514|Other|Single injection|Local anesthetic injection with a mixture of 35 mL of lidocaine 1.0%-bupivacaine 0.25% with epinephrine 5 µ/mL and dexamethasone 2 mg, in the middle of the three cords of the brachial plexus
15908513|NCT03584074|Drug|Pregabalin 75mg|Orally taken twice daily for 8 weeks
15906972|NCT03595514|Other|Double injection|Local anesthetic injection with a mixture of 35 mL of lidocaine 1.0%-bupivacaine 0.25% with epinephrine 5 µ/mL and dexamethasone 2 mg, in the middle of the three cords of the brachial plexus as well as at the intersection of the subclavian artery and the medial cord.
15906973|NCT03595514|Drug|lidocaine, bupivacaine, epinephrine, dexamethasone|lidocaine 1.0%-bupivacaine 0.25% with epinephrine 5 µ/mL and dexamethasone
15906974|NCT03595501|Device|Hematology Analyzer - OLO|Complete blood counts from OLO will be determined from analysis of whole blood samples
15906975|NCT03595501|Device|Hematology Analyzer - Predicate|Complete blood counts from Predicate will be determined from analysis of whole blood samples
15906976|NCT03595488|Drug|Dupilumab|dupilumab 300 mg subcutaneous injection every 2 weeks
15906977|NCT03595462|Other|Snack|"Hummus and Pretzels- The study participants will be provided with a hummus and pretzels snack to consume every day for a week. The energy content of the hummus and pretzels will be ~240 kcal. The hummus and pretzels contain 6 g protein, 27 g carbohydrates, 0 g sugar, 4 g fiber, and 12 g fat.
~Granola Bars- The study participants will be provided with two granola bars to consume every day for a week. The energy content of the two granola bars will be ~240 kcal. The two granola bars contain 4 g protein, 38 g carbohydrates, 16 g sugar, 2 g fiber, and 9 g fat."
15906978|NCT03595462|Other|No Snack|The study participants will not be provided with any snack and will be told to consume nothing from 2-4pm for a week.
15906979|NCT03595449|Drug|Lidocaine jelly|lidocaine 2% jelly applied during Mohs surgery
15906980|NCT03595449|Drug|Surgilube|surgilube (placebo) applied during Mohs surgery
15906981|NCT03595436|Dietary Supplement|Pea Protein-20g|The study participants will be provided with breakfast preloads to consume. The energy content of the breakfast preload will be standardized to ~325 kcal. This preload will include 20 g pea protein, 5 g mixed protein (from yogurt and peanut-butter), 40 g carbohydrates, and 7 g fat. The preload is a yogurt-based (chocolate-peanut butter flavored) breakfast.
15906982|NCT03595436|Dietary Supplement|Pea Protein-30g|The study participants will be provided with breakfast preloads to consume. The energy content of the breakfast preload will be standardized to ~325 kcal. This preload will include 30 g pea protein, 5 g mixed protein (from yogurt and peanut-butter), 32 g carbohydrates, and 7 g fat. The preload is a yogurt-based (chocolate-peanut butter flavored) breakfast.
15906983|NCT03595436|Dietary Supplement|Pea Protein-40g|The study participants will be provided with breakfast preloads to consume. The energy content of the breakfast preload will be standardized to ~325 kcal. This preload will include 40 g pea protein, 5 g mixed protein (from yogurt and peanut-butter), 24 g carbohydrates, and 7 g fat. The preload is a yogurt-based (chocolate-peanut butter flavored) breakfast.
15906984|NCT03595436|Dietary Supplement|Whey Protein-20g|The study participants will be provided with breakfast preloads to consume. The energy content of the breakfast preload will be standardized to ~325 kcal. This preload will include 20 g whey protein, 5 g mixed protein (from yogurt and peanut-butter), 40 g carbohydrates, and 7 g fat. The preload is a yogurt-based (chocolate-peanut butter flavored) breakfast.
15906985|NCT03595436|Dietary Supplement|Carbohydrate Control|The study participants will be provided with breakfast preloads to consume. The energy content of the breakfast preload will be standardized to ~325 kcal. This preload will include 5 g mixed protein (from yogurt and peanut-butter), 59 g carbohydrates, and 7 g fat. The preload is a yogurt-based (chocolate-peanut butter flavored) breakfast.
15906986|NCT03595423|Procedure|Surgical AVR with bioprosthetic or mechanical prosthesis|Surgical AVR with bioprosthetic or mechanical prosthesis
15906987|NCT03595410|Other|Recurrence laryngeal cancer|Recurrence laryngeal cancer has a wide range of invasion, rapid progression and poor prognosis.
15906988|NCT03595397|Drug|Bupivacaine|20 patients will receive mid-thoracic epidural analgesia with a loading dose of 8 ml of 0.125% bupivacaine, followed by continuous infusion of 8 ml/hour
15906989|NCT03595397|Drug|Magnesium Sulfate|20 patients will receive mid-thoracic epidural analgesia with a loading dose of 8 ml mixture of 0.125% bupivacaine and 30 mg/kg Magnesium Sulfate, followed by continuous infusion of 8 ml/hour mixture of 0.125% bupivacaine and 20% Magnesium sulfate
15906990|NCT03595397|Drug|Fentanyl|20 patients will receive mid-thoracic epidural analgesia with a loading dose of 8 ml of 0.125 bupivacaine and 2 mcg/ml fentanyl, followed by continuous infusion of 8 ml/hour.
15906991|NCT03595397|Procedure|Thoracic epidural|All patients will receive mid-thoracic epidural analgesia
15906992|NCT03595384|Behavioral|Soccer-based adaptation to the DPP|"Participants will complete online education modules during an initial 12 week conditioning phase where they will participate in soccer drills and other fitness routines (two 1-hour sessions per week). At the 12 week mark participants will transition onto a soccer league team for the following 12 weeks where they will continue to complete online modules and meet with the soccer coach monthly.
~During the soccer sessions and games participants will be fitted with a wearable soccer-specific device to measure how much they move and their heart rate. In addition, they will also be asked to wear a Garmin fitness tracker for the duration of the study to measure steps and moderate and vigorous activity.
~The online education will be a version of the Diabetes Prevention Program and can be completed on a phone or computer with internet access."
15906993|NCT03595371|Drug|dapansutrile|500 mg dapansutrile administered twice daily (with a potential to increase the dosage to 2 g dapansutrile daily) for a duration of up to 14 consecutive days.
15906994|NCT03595358|Diagnostic Test|Ellume Home Flu Test|The Ellume Home Flu Test is a rapid in vitro diagnostic test for the detection of influenza A or influenza B in nasal swab samples.
15906995|NCT03595358|Diagnostic Test|ellume.lab Flu A+B Test|The ellume.lab Flu A+B Test is a rapid in vitro diagnostic test intended to be used at point-of-care for the detection of influenza A or influenza B in nasal swab samples.
15906996|NCT03595358|Diagnostic Test|Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)|Reverse Transcriptase Polymerase Chain Reaction (RT_PCR) is a molecular diagnostic technique for the detection and identification of influenza viruses, both for clinical samples and isolates. The Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) allows template viral RNA to be reverse transcribed producing complementary DNA (cDNA) which can then be amplified and detected.
15906997|NCT03595358|Diagnostic Test|Viral culture|Nasopharyngeal samples will be inoculated into appropriate culture media for influenza viral culture. In this test, the virus is actually grown and further identified in the laboratory as influenza A or B.
15906998|NCT03595345|Procedure|Liver transplantation|Liver transplantation
15936769|NCT03367156|Other|Questionnaire Administration|Ancillary studies
15906999|NCT03595332|Other|Summer activity program|Children receive a summer scorecard to facilitate access to local facilities for exercise.
15907000|NCT03595319|Drug|Sevoflurane|Inhaled sevoflurane until allocated dose (see adaptive protocol)
15907001|NCT03595306|Dietary Supplement|Prebiotic A - inulin|Pre-weighed packages will be given twice daily for 5 days.
15907002|NCT03595306|Dietary Supplement|Prebiotic B - galactooligosaccharides(GOS)|Pre-weighed packages will be given twice daily for 5 days.
15907003|NCT03595306|Dietary Supplement|Prebiotic C - wheat dextrin|Pre-weighed packages will be given twice daily for 5 days.
15907004|NCT03595293|Device|fNIRs-based Neurofeedback|Patients receive fNIRs-based neurofeedback from the rDLPFC to allow them to modify activation within this area.
15907005|NCT03595293|Device|Sham feedback|Patients receive fNIRs-based sham feedback from the left zygomatic area to allow them to modify activation within this area.
15907007|NCT03595267|Other|Point-of-care screening|"After consent is obtained, a registered nurse will administer a demographic questionnaire, collecting the participant's personal health number, age, gender, date of birth, and name of community. Physical data including height, weight, and blood pressure will also be collected. A blood sample and a urine sample will be taken, with point-of-care testing being performed during the screening appointment to allow for results of the testing to be received and discussed with each patient at the time of the appointment. After screening, to ensure a closed loop system of care, patients at the highest risk of kidney failure will be referred to a nephrologist, while those at lower risk will be referred to their primary care provider with specific treatment and re-testing recommendations. If a participant has no primary care provider, one will be found."
15907008|NCT03595254|Behavioral|Thrive|Computerized Cognitive Behavior Therapy program
15907009|NCT03595241|Device|Spinal cord stimulation by implanted device.|Spinal cord stimulation (SCS) protocol from the implanted device. This involves activation of the device for the (SCS) protocol including Burst DR therapy.
15907010|NCT03595228|Biological|BN-Brachyury plus radiation|MVA-BN-Brachyury injections will be given on day 0 and 14. FPV-Brachyury injection will be given on day 28, followed by radiation on days 42 through approximately day 70. FPV-Brachyury will then be given two weeks after radiation then every 6-12 weeks through 110 weeks after radiation is complete.
15907011|NCT03595215|Device|TENS|Transcutaneous electrical nerve stimulation
15907012|NCT03595202|Drug|TS-143|Subjects should take 4 capsules once and 3 times per day in step 1. Subjects should take 2 capsules once and 3 times per day in step 2.
15907013|NCT03595202|Drug|Placebo|Subjects should take 4 capsules once and 3 times per day in step 1. Subjects should take 2 capsules once and 3 times per day in step 2.
15907014|NCT03595189|Drug|Cilastatin|Dose escalation 3-hour single intravenous administration
15907015|NCT03595189|Drug|Placebo|3-hour single intravenous administration
15907016|NCT03595176|Device|Lithotripsy|Deliver Lithotripsy to the target vessel prior to placing a coronary stent.
15907017|NCT03595163|Drug|Sevoflurane|After anesthesia induction and at the end of the operation, all patients were taken 2-3ml arterial blood respectively.The blood was put at normal temperature for 30 minutes.Then the serum was centrifuged to measure the homocysteine and folic acid concentrations.
15907018|NCT03595163|Drug|Propofol|After anesthesia induction and at the end of the operation, all patients were taken 2-3ml arterial blood respectively.The blood was put at normal temperature for 30 minutes.Then the serum was centrifuged to measure the homocysteine and folic acid concentrations.
15907019|NCT03595150|Drug|Diclofenac|Diclofenac rectally given before the ERCP to prevent pancreatitis
15907020|NCT03595137|Device|Sono with Device|In Group D, simple needle guide device was attached to the sono probe. Device was designed to assist the detection of the puncture site. After induction of anesthesia, sono-guided internal jugular vein cannulation was performed.
15907021|NCT03595137|Device|Sono only|In group S, sono-guided internal jugular vein cannulation was performed after induction of anesthesia
15907024|NCT03595111|Procedure|myocardial biopsy|Myocardial cell edema either focal or diffuse was detected in histopathological examination
15907025|NCT03595098|Behavioral|Family Based Cognitive Behavioural Therapy|Family Based Cognitive Behavioural Therapy (FCBT) focuses on the interrelation between thought, emotion, and behaviour, Exposure and Response Prevention, family involvement, homework assignments, and formulating of specific goals for the child. The important, active components is Exposure and Response Prevention. It involves exposing the child to a feared object, situation or thought, and preventing the child from carrying out compulsions to show the child that distress/anxiety can decrease or disappear without performing rituals.
15907026|NCT03595098|Behavioral|Family Based Psychoeducation/Relaxation Training|Family-based Psychoeducation/Relaxation Training (FPRT) as an active control matches the experimental intervention as closely as possible, many elements of the control intervention are similar to FCBT. The main and intended difference between the two approaches is the absence of the Exposure and Response Prevention component, which is deemed the most effective treatment for OCD.
15907027|NCT03595085|Procedure|catheter directed fragmentation and thrombolysis|A(6)F multipurpose catheter will be advanced over a guide wire under fluoroscopic guidance and used to measure right heart and pulmonary artery pressures, then mechanical catheter fragmentation will be done using a pigtail catheter. The catheter will be quickly spun manually so as to fragment the central thrombus and establish initial flow into pulmonary artery. After ensuring initial flow, Initial bolus dose of streptokinase (250.000 international unit) will be given over 10 min followed by continuous infusion of (100.000 international unit per hour)for 24 hours
15907028|NCT03595085|Drug|Streptokinase|intravenous streptokinase at a dose of 250 000 international unit as a loading dose over 30 minutes, followed by 100 000 international unit per hour over 12-24 hours
15907029|NCT03595072|Other|observation of VNS stimulation effects|ECOGs will be recorded during VNS stimulation and inter stimulation periods
15907030|NCT03595059|Drug|ABBV-155|Intravenous (IV) Infusion
15907031|NCT03595059|Drug|Paclitaxel|Intravenous (IV) Infusion
15907032|NCT03595059|Drug|Docetaxel|Intravenous (IV) Infusion
15907111|NCT03594500|Other|No PockeTalker|The control group will not receive PockeTalkers while they receive care in the ED
15907033|NCT03595046|Procedure|erector spinae plane block (20 mL of 0.25% ropivacaine with dexamethasone 5mg)|In group E, The patient was placed in a sitting position and a high-frequency linear ultrasound transducer was placed in a longitudinal orientation 3 cm lateral to the thoracic spinous process. Three muscles were identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. An 8-cm 22-gauge block needle was inserted in a cephalad-to-caudad direction until the tip lay in the interfascial plane between transverse process and erector spinae muscles, as evidenced by visible linear spread of fluid between erector spinae muscles and the bony acoustic shadows of the transverse process. A total of 20 mL of 0.25% ropivacaine with dexamethasone 5mg was injected here.
15907034|NCT03595046|Procedure|thoracic paravertebral block(10 mL 0.25% ropivacaine with dexamethasone 5mg)|2) In group P, an appropriate thoracic spinous precess is located by positioning the probe in the transverse plane. Then the probe is moved laterally to locate the transverse process. The probe is manipulated slightly caudad or cephala to locate the intercostal space. The transverse process is visualized medially with the pleura dipping under the inferolateral aspect. The internal intercostal membrane, which is contiguous with the superior costotransverse ligament, was generally seen as a thin, radiopaque line extending from the transverse process, creating a wedge-shaped pocket, which represents the thoracic paravertebral space. A 22-gauge, facet-tip needle is advanced, in plane, from the lateral aspect of the ultrasound probe. When the needle pierced the internal intercostal membrane, and after aspiration demonstrated the absence of air or blood, 10 mL 0.25% ropivacaine with dexamethasone 5mg deposited in 5-mL increments.
15907035|NCT03595033|Device|iPad app-based intervention|The 1-hour of home based intervention will break into three 20-min sessions, each including iPad apps targeting one of the three domains of deficits: visual attention, visual-spatial reasoning, and visual-motor skills.
15907036|NCT03595007|Behavioral|Kids Kicking Cancer program|Individual instruction on how to lower stress and life challenges. Patient and martial artist will work together to identify obstacles that interfere with methadone goal reduction. Training will include learning certain martial arts rituals and breathing techniques. Patients will receive audio meditations for smart phone devices and regular reminders to practice. Each weekly meeting will be supplemented by 3 phone calls per week from the martial artist to support the training. Additionally a virtual reality device will be used to help lower stress.
15907037|NCT03594994|Behavioral|Sleep extension|Extend time-in-bed to 8 hours
15907038|NCT03594981|Biological|CMV/AdV /EBV/BKV specific T cells|Each cohort of 2 patients will be treated and observed for 45 days for toxicity, dose escalation, and GvHD. The algorithm of sequentially adaptive EffTox trade-off-based design of Thall et al will be used to determine the dose for each cohort. If 1x107CTL/m2 results in unacceptable toxicity or efficacy, the study will be closed to accrual.
15907039|NCT03594968|Diagnostic Test|polycystic ovary syndrome|3 to 5th day of the women's normal cycle, we will perform a routine gynecological examination, a basic vaginal ultrasound, a basal hormone profile evaluation
15907040|NCT03594955|Drug|SAR440234|Pharmaceutical form:lyophilisate to be resuspended in solution Route of administration: intravenous
15907041|NCT03594942|Diagnostic Test|procto sigmoidoscopy and biopsy if required|procto sigmoidoscopy of patients presenting with per rectal bleed will be carried out to locate the source of bleeding and biopsy if required.
15907042|NCT03594929|Device|Active RIC|
15907043|NCT03594929|Device|Sham Control|
15907044|NCT03594916|Device|Active tDCS|The anode and cathode sponge electrode (51 cm2) will be placed over C3 and FP2 (10-20 system) respectively. 2 mA current will be applied continuously for 20 minutes.
15907045|NCT03594916|Device|Sham tDCS|The anode and cathode sponge electrode (51 cm2) will be placed over C3 and FP2 (10-20 system) respectively. 2 mA current will be applied for 30 seconds at the beginning.
15907046|NCT03594903|Behavioral|video intervention (therapy expectation violation)|The investigators asked experts (psychotherapist and scientists in the area of clinical psychology) about typical therapy expectation violations in therapy and searched the literature for information about typical therapy processes and outcomes. Having these information they designed a script for the experimental video. The patients in the video are played by actors aged from 28 to 58 years (two male and two female actors). Patients are representing common mental disorders (depression, anxiety disorder, alcohol addiction, depression after physical disease). The abbreviated name, age and disorder of the patients is displayed for 3 seconds in the video. The patients are giving information about the mostly positive outcome and the process of their therapy. All participants are watching a video with all patients (7 minutes). The videos (control and experimental group) have been evaluated by 12 experts (psychotherapist and scientists in the area of clinical psychology).
15907047|NCT03594903|Behavioral|video intervention (symptoms+ expectation)|Participants in the control group are watching a video with the same patients (actors) as in the experimental video. In this video patients are shown before or after the first therapy session. They are giving information about symptoms and their expectation on therapy but NOT about therapy outcome.
15907048|NCT03594890|Biological|OVX836 (Intramuscular)|2 consecutive administrations of OVX836 vaccine at Day 1 and Day 29.
15907049|NCT03594890|Biological|Placebo (Intramuscular)|2 consecutive administrations of placebo at Day 1 and Day 29.
15907050|NCT03594890|Biological|OVX836 (Intranasal)|2 consecutive administrations of OVX836 vaccine at Day 1 and Day 29.
15907051|NCT03594890|Biological|Placebo (Intranasal)|2 consecutive administrations of placebo at Day 1 and Day 29.
15907052|NCT03594877|Dietary Supplement|Sublimated mare milk|The dietary supplement mare milk product, which is obtained from fresh (few hours) through sublimation process. This product is first mixed with warm water (37-38 degrees of Celsius) and then will be given to participants.
15907053|NCT03594864|Procedure|Liver transplantation with hyper-reduced grafts|Live donor liver transplantation using non-anatomical in-situ ultrasound-guided reduction of left lateral segments with preparation of a graft that is larger than a monosegment, but smaller than Segments 2 and 3.
15907069|NCT03594799|Dietary Supplement|Cocktail intervention|Subjects are in strict head down tilt bed rest at all time (including for taking showers etc.) for 60 days. In addition subjects are receiving a daily supplementation of a Cocktail. The daily dose of Cocktail consists of 6 pills per day: 2 at breakfast, 2 at lunch and 2 at diner. This will be equivalent to a daily dose of around 741 mg of bioactive polyphenols associated with Omega-3, Selenium and Vitamine E.
15907160|NCT03594110|Drug|Matching placebo|Taken daily with or without food
15936770|NCT03367143|Drug|Lenalidomide|
15907054|NCT03594851|Behavioral|Pittsburgh Sleep Quality Index|The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a 1-month time interval. The measure consists of 19 individual items, creating 7 components that produce one global score, and takes 5-10 minutes to complete. Developed by researchers at the University of Pittsburgh, the PSQI is intended to be a standardized sleep questionnaire for clinicians and researchers to use with ease and is used for multiple populations. The questionnaire has been used in many settings, including research and clinical activities, and has been used in the diagnosis of sleep disorders. Clinical studies have found the PSQI to be reliable and valid in the assessment of sleep problems to some degree, but more so with self-reported sleep problems and depression-related symptoms than actigraphic measures.
15907055|NCT03594851|Behavioral|Sleep diary|A sleep diary is a record of a patient's sleep patterns and habits that can be extremely useful in helping doctors make a diagnosis of a sleep disorder and better determine if a sleep study should be prescribed.
15907056|NCT03594851|Behavioral|Katz Index of Independence in Activities of Daily Living|Katz Activities of Daily Living is a validated tool to assess functional status as a measurement of the elder's ability to perform activities of daily living independently. Elders are scored yes/no for independence in each of six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less implies severe functional impairment.
15907057|NCT03594851|Behavioral|Lawton Instrumental Activities of Daily Living|"Lawton's Instrumental Activities of Daily Living (IADL) scale was developed to assess more complex activities (termed instrumental activities of daily living) necessary for functioning in community settings (e.g., shopping, cooking, managing finances). The capacity to handle these complex functions normally is lost before basic activities of daily living which are measured by Activities of Daily Living scales. Therefore, assessing Instrumental Activities of Daily Living may identify incipient decline in older adults who are otherwise capable and healthy.The Lawton Instrumental Activities of Daily Living scale takes approximately 10 to 15 minutes to administer. It contains 8 items that are rated with a summary score from 0 (low functioning) to 8 (high functioning). This scale can be administered through an interview or by a written questionnaire. The patient or a caregiver who is familiar with the patient can provide the answers."
15907058|NCT03594851|Behavioral|Neuropsychiatric Inventory (Cummings)|"Neuropsychiatric Inventory is submitted to the caregiver, if the patient has a Mini Mental State Examination score between 10 and 20.
~The Neuropsychiatric Inventory (NPI) was developed by Cummings et al. (1994) to assess dementia-related behavioral symptoms which they felt other measures did not sufficiently address. The NPI originally examined 10 sub-domains of behavioral functioning: delusions, hallucinations, agitation/aggression, dysphoria, anxiety, euphoria, apathy, disinhibition, irritability/lability, and aberrant motor activity. Two more sub-domains have been added since its development: night-time behavioral disturbances and appetite and eating abnormalities (Cummings, 1997). This wide variety of domains means that, unlike other dementia measures, the NPI is able to screen for multiple types of dementia, not just Alzheimer's Disease."
15907059|NCT03594851|Behavioral|Mini Zarit Caregiver Burden Scale, for the caregiver|Mini Zarit Caregiver Burden Scale, for the caregiver, if the patient has a Mini Mental State Examination score between 10 and 20.
15907060|NCT03594851|Behavioral|Mini Mental state examination|"It is an 11-question tool to evaluate cognitive functions. The maximum score is 30. A score of 23 or lower is indicative of cognitive impairment. The Mini Mental state examination takes only 5-10 minutes to administer and is therefore practical to use repeatedly and routinely.
~The MMSE has been validated and extensively used in both clinical practice and research, since its creation in 1975"
15907061|NCT03594851|Behavioral|Cornell Scale for Depression in Dementia|The Cornell scale For Depression in Dementia is a scoring system specifically developed to assess signs and symptoms of major depression in patients with dementia. The 19 parameters measured are clustered into five groups: mood-related signs, behavioural disturbances, physical signs, cyclic functions and ideational disturbances. The Cornell scale For Depression in Dementia has been shown to be sensitive, reliable and valid for assessing depression in patients with Alzheimer's disease.
15907062|NCT03594851|Behavioral|Quality of Life in Alzheimer's Disease|The Quality of Life in Alzheimer's Disease is a brief, 13-item measure designed specifically to obtain a rating of the patient's Quality of Life from both the patient and the caregiver. It was developed for individuals with dementia, based on patient, caregiver, and expert input, to maximize construct validity, and to ensure that the measure focuses on quality of life domains thought to be important in cognitively impaired older adults. It uses simple and straightforward language and responses & includes assessments of the individual's relationships with friends and family, concerns about finances, physical condition, mood, and an overall assessment of life quality
15907063|NCT03594838|Other|HCV viremia testing approaches|Blood draw and HCV viremia testing is done at point of service (Intervention A) Blood draw at point of service and HCV viremia testing at a centralized laboratory (Intervention B)
15907064|NCT03594825|Drug|Valsartan|Different time of taking medicine
15907065|NCT03594812|Device|Radiofrequency|Radiofrequency protocol - The radiofrequency protocol was performed in dorsal decubitus, with the head elevated at 45º. The application was in capacitive mode, with a 5 cm electrode, always in movement. The duration of the application was established in 20 minutes, maintaining the local temperature between 40ºC to 42 ºC at the epidermis.
15907066|NCT03594812|Device|Radiofrequency without power|Radiofrequency protocol - The radiofrequency protocol was performed in dorsal decubitus, with the head elevated at 45ºC (Celsius degrees). The application was in capacitive mode, with a 5 cm electrode, always in movement. The duration of the application was established in 20 minutes, maintaining the local temperature between 40ºC to 42 ºC at the epidermis. In this group, the radiofrequency device was switched off.
15907067|NCT03594812|Device|Aerobic exercise|Aerobic exercise protocol - 40 minutes of aerobic moderate-intensity exercise (45-55% of reserve heart rate) using Karvonen´s formula, performed on a cycloergometer. The duration of the exercise was divided into three parts: warm-up (from 0 to 5 minutes); body (from 5 to 35 minutes); and cooling (from 35 to 40 minutes). The entire protocol was monitored through the Polar® brand heart rate monitor and watch.
15907068|NCT03594799|Other|Bed Rest Control Group|Subjects are in strict head down tilt bed rest at all time (including for taking showers etc.) for 60 days.
15907109|NCT03594513|Drug|chlorhexidine rinse|All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures.
15907110|NCT03594500|Other|PockeTalker|The intervention group will receive PockeTalkers (hearing assistance devices) while they receive care in the ED
15907070|NCT03594786|Device|endovascular aneurysm repair (EVAR)|Patient will be enrolled when the decision of an endovascular procedure with supra renal fixation is required. Before the intervention, Duplex scan will be necessary to evaluate renal arteries ostia. This exam will be realised in the month after the intervention and one year later.
15907071|NCT03594773|Behavioral|Cognitive Behavioral Therapy|Participants will receive 8 one-on-one sessions over 8 to 12 weeks.
15907072|NCT03594773|Behavioral|Interpersonal Psychotherapy|Participants will receive 8 one-on-one sessions over 8 to 12 weeks.
15907073|NCT03594760|Diagnostic Test|18F-DCFPyL IV injection|Patient will receive one injection of 18F-DCFPyL and undergo PET-CT imaging
15907074|NCT03594747|Drug|Tislelizumab Carboplatin Paxlitaxel|Treatment for advanced NSCLC
15907075|NCT03594747|Drug|Tislelizumab Carboplatin Nab-paxlitaxel|Treatment for advanced NSCLC
15907076|NCT03594747|Drug|Carboplatin Paclitaxel|Treatment for advanced squamous NSCLC
15907077|NCT03594734|Behavioral|Group Lifestyle Balance™|The Group Lifestyle Balance™ (GLB) program is a self-management intervention that has been shown to result in weight-loss and reduce the risk for Type 2 diabetes through increased physical activity and healthy eating behaviors in the general population. The GLB program curriculum used in this RCT will be adapted for individuals with TBI.
15907078|NCT03594734|Other|Attention Control Group|"The attention control group will receive the same contact or attention as the intervention group. The attention control group will meet at the same frequency as the intervention group. Education for the sessions will be composed of content from the TBI Model Systems Knowledge Translation Center's factsheets. General topics will include discussion on (1) healthy brain and effects of TBI on cognitive, emotional, and behavioral functioning, (2) expectations for recovery, (3) preventative and management strategies for common TBI sequela (e.g. inability and impulsivity), (4) stress management, (5), signs and symptoms of depression, and (6) strategies for effective communication."
15907079|NCT03594721|Other|Marvel AM|Study staff will perform each application of approximately 2 mg/cm2 or 50 µL of test product to the appropriate 5x5cm2 test location on the lower back at each of ten sequential visits.
15907080|NCT03594708|Dietary Supplement|Nutrition supplement|Fermentable fiber, omega-3 fatty acid, vitamin D3, vitamin E, zinc
15907081|NCT03594708|Dietary Supplement|Placebo supplement|rice starch, light olive oil, vegetable oil
15907082|NCT03594695|Diagnostic Test|HSCRP and NLR|hs-CRP levels and NLR values will be studied from routine blood samples.
15907083|NCT03594682|Other|Intervention/treatment|"experimentalgroup initial dose：
~250mg qod
~250mg qd/500mg qd by turn
~500mg qd control group： 750mg qd"
15907084|NCT03594669|Other|Intervention|Multi-modal sensorimotor training interventions, including vestibular, oculomotor, neuromotor, and postural control/ balance exercises.
15907085|NCT03594656|Drug|Ganoderma|0.8g twice daily
15907086|NCT03594656|Drug|Placebos|0.8g twice daily
15907087|NCT03594630|Drug|Chemotherapy|Receive chemotherapy
15907088|NCT03594630|Other|Patient Observation|Receive active surveillance
15907089|NCT03594630|Other|Questionnaire Administration|Ancillary studies
15907090|NCT03594630|Procedure|Resection of Rectum|Undergo surgical resection
15907091|NCT03594617|Behavioral|Interaction Competencies with Children - for Caregiver|"Interaction Competencies with Children - for Caregiver (ICC-C) aims to reduce maltreatment and to improve care quality in institutional care facilities. Following the idea of a train-the-trainer approach, ICC-C is designed to be delivered by trained local facilitators. ICC-C is based on attachment, behavioral and social learning theories.
~The key principles are its feasibility in low-resource contexts, participatory approach, and practical orientation. ICC-C includes sessions on (a) caregiver-child interaction, (b) maltreatment prevention, (c) effective non-violent caregiving strategies, and (d) identifying and supporting burdened children."
15907092|NCT03594604|Drug|Norethindrone|Women desiring to postpone their periods may be randomized to norethindrone 5mg three times daily.
15907093|NCT03594604|Drug|oral contraceptive pill|Women desiring to postpone their periods may be randomized to daily oral contraceptive pills.
15907094|NCT03594591|Drug|Antidiabetic treatment by usual care|Observation of changes in the microcirculation after optimization of antidiabetic therapy by usual care.
15907095|NCT03594578|Behavioral|Episodic future thinking|Prospective thinking intervention
15907096|NCT03594578|Behavioral|Episodic recent thinking|Sham episodic thinking
15907097|NCT03594565|Drug|Fluticasone Propionate|Local Fluticasone Propionate use prior to continuous glucose monitoring system insertion
15907098|NCT03594552|Drug|Arbaclofen_15|Single oral dose (15mg)
15907099|NCT03594552|Drug|Arbaclofen_30|Single oral dose (30mg)
15907100|NCT03594552|Drug|Placebo|Single oral dose placebo (oral tablet)
15907101|NCT03594539|Other|Withholding standard phosphate binder|In this trial, placebo represents the intervention and not the control. Standard therapy for hyperphosphatemia in end-stage renal disease includes treatment with a phosphate binder. In this trial the intervention will be to withhold the phosphate binder and use placebo instead. In this way the effect of a higher serum phosphate can be evaluated.
15907102|NCT03594526|Behavioral|Maternal support to become mother|"AMACOM-PRI: Apoyo Materno para Convertirse en Madre - Primerizas. Maternal support to become first-time mothers is an intervention based on the mid-range nursing theory of Ramona Mercer, whose purpose is to empower first-time mothers in their new maternal role, favoring the mother-child bond, strengthening social support and maternal self-efficacy, consists of.
~Four Home visits , in the first week; first month of baby life; at three months; and the fourth postpartum month.
~Four Educational sessions and support sessions for maternal empowerment in each home visit.
~Telephone follow-up: at 15 days; a month and a half; at two and a half months; and three and a half months postpartum."
15907103|NCT03594526|Behavioral|Control Group: usual care|"This intervention is usual care, which consists of:
~care of the mother and her newborn during the puerperium
~Teaching about breastfeeding."
15907104|NCT03594513|Procedure|MCAF|Periodontal surgical technique to treat gingival recessions.
15907105|NCT03594513|Procedure|PR|Restorative procedure to treat tooth structure loss.
15907106|NCT03594513|Procedure|CTG|Autogenous graft harvested from palate placed in the surgical site.
15907107|NCT03594513|Procedure|XMD(Mucoderm®)|Xenogenous graft placed in the surgical site.
15907108|NCT03594513|Drug|Sodium dipyrone|All participants were instructed to take 500 mg sodium dipyrone just in case of pain.
15907112|NCT03594487|Drug|FMP30 Donor Stool|FMP30 is manufactured by the non-profit stool bank Openbiome. Each FMP30 filtered donor stool engraftment has approximately 12.5g of stool per 30mL of normal saline. It is homogenized in sterile normal saline.
15907113|NCT03594487|Procedure|Fecal Microbiota Transplantation (FMT) of FMP30 Donor Stool|Three doses of filtered donor stool engraftments homogenized in sterile normal saline (FMP30), obtained from the non-profit stool bank OpenBiome, will be administered via colonoscopy in patients with Relapsing-Remitting Multiple Sclerosis. FMT dosage via colonoscopy may include a lower amount of transplanted stool at the discretion of the study gastroenterologist if there are any peri-procedural safety or technical considerations. Total FMT dose (in milliliters) will be documented.
15907114|NCT03594487|Other|Observational Control|Subjects, who otherwise satisfy study inclusion criteria based on their MS phenotype, demographics, disease duration and prior use of allowable MS therapies, will be recruited as a comparison observational group to measure stability of stool and serum immunological measures.
15907115|NCT03594474|Other|Intravenous lipid emulsion|using higher dose of IV lipids after birth
15907116|NCT03594461|Drug|Aflibercept Injection|Intense Treatment Regimen for Refractory Neovascular Age-Related Macular Degeneration with or without Polypoidal Choroidal Vasculopathy
15907117|NCT03594448|Procedure|Specimen Collection|Undergo collection of blood samples
15907118|NCT03594448|Procedure|Serial Liquid Biopsy|Undergo serial liquid biopsy
15907119|NCT03594435|Drug|Ibudilast|targets neurotrophin signaling and neuroimmune function
15907120|NCT03594435|Drug|Placebo oral capsule|matched to active drug, ibudilast
15907121|NCT03594422|Drug|HQP1351|HQP1351 Orally, once every other day (QOD) for consecutive 4 weeks each cycle.
15907122|NCT03594409|Diagnostic Test|Biochemistry of gall stones|Analysis of gallstones is done to determine the biochemical types of gallstone like cholesterol stone, pigmented stones or mix stones
15907123|NCT03594396|Drug|Olaparib|Olaparib 300mg bid will be given on days 1-28 days without rest.
15907124|NCT03594396|Drug|Durvalumab|A fixed dose of durvalumab 1500 mg is given via IV infusion on Day 15.
15907125|NCT03594383|Device|ULTRASOUND|Lung ultrasound done through POCUS to diagnose pneumonia
15907126|NCT03594344|Procedure|Hyperbaric oxygen therapy|Breathing 100% oxygen for 30+30+30 min at 2,4 ATA. in a multiplace hyperbaric chamber. Total of 30 sessions
15907127|NCT03594331|Drug|Low-dose PvP001|Low-dose PvP001
15907128|NCT03594331|Drug|Medium-dose PvP001|Medium-dose PvP001
15907129|NCT03594331|Drug|High-dose PvP001|High-dose PvP001
15907130|NCT03594331|Drug|Placebo|100 mL liquid with no drug
15907131|NCT03594305|Behavioral|Educational seminar|Religious leaders will be invited to participate in a one-day seminar led by Tanzanian religious leaders and physicians. The religious, cultural, and medical aspects of family planning will be discussed and seminar attendees will be given ample time for group discussions.
15907132|NCT03594292|Device|FASTFORWARDTM Bunion|The participants will be assign to implantation of FASTFORWARDTM Bunion correction system surgery as a experimental group.
15907133|NCT03594292|Procedure|Conventional surgery|The participants will assign to conventional surgery as a control group, the procedure is a standard treatment for the 1st metatarsal hallux valgus.
15907134|NCT03594279|Behavioral|Community Mobilization|Community Mobilization
15907135|NCT03594279|Behavioral|Community Mobilization and Community Incentive|Community Mobilization and Community Incentive
15907136|NCT03594266|Device|Therapy A spinal cord stimulation parameter set using BIO-RNA system and associated components|Therapy A stimulation patterns
15907137|NCT03594266|Device|Therapy B spinal cord stimulation parameter set using BIO-RNA system and associated components|Therapy B stimulation patterns
15907138|NCT03594253|Behavioral|Regulation Focused Psychotherapy for Children|RFP-C is a manualized, psychodynamic psychotherapy that last 10 weeks. Children meet individually with a therapist for play therapy (twice a week for 16 sessions) and parents meet with the therapist for four full sessions (without the child).
15907139|NCT03594240|Drug|Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM)|Vitamin B complex tablets (Neurorubine TM -Forte Lactab TM) once daily
15907140|NCT03594240|Dietary Supplement|Placebo|Patients in placebo group received placebo that were similar in appearance to Vitamin B complex tablets and the administered dose was as the same schedule as Vitamin B complex.
15907141|NCT03594227|Drug|ATI-501 400mg BID (Low dose)|ATI-501 400mg BID oral low dose for oral administration
15907142|NCT03594227|Drug|ATI-501 600mg BID (Mid dose)|ATI-501 600mg BID oral mid dose for oral administration
15907143|NCT03594227|Drug|ATI-501 800mg BID (High dose)|ATI-501 800mg BID high dose for oral administration
15907144|NCT03594227|Drug|Placebo|Placebo - oral administration
15907145|NCT03594214|Diagnostic Test|serum vitamin d level measured by ELISA kit|serum vitamin d level will be measured by a blood sample from newly diagnosed breast cancer patients just after diagnosis (either by surgery specimen or FNA or excisional biopsy specimen) and before receiving any type of treatment for breast cancer
15907146|NCT03594201|Other|semen pretreatment|semen pretreatment
15907147|NCT03594188|Procedure|anesthetic methods|Patients will receive standard GA or LA for RF surgery.
15907148|NCT03594175|Drug|CUSA-081|Participants will receive 1 or 2 doses of CUSA-081 0.7 mg/2 mL directly into the catheter lumen
15907149|NCT03594175|Drug|Placebo|Participants will receive 1 or 2 doses of placebo (normal saline) directly into the catheter lumen
15907150|NCT03594175|Drug|Alteplase|Participants will receive 1 or 2 doses of alteplase, 2 mg/2 mL, directly into the catheter lumen
15907151|NCT03594162|Drug|iC9-CAR19 cells|One of two dose levels will be given: 1 x 10^5 or 5 x 10^5
15907152|NCT03594162|Drug|AP1903|Subjects who develop grade 4 CRS or grade 3 CRS that is refractory to standard of care interventions will be given AP1903 at .4 mg/kg.
15907153|NCT03594162|Drug|Cyclophosphamide|900 mg/m^2 IV over 1 hour on day 4 of lymphodepleting chemotherapy.
15907154|NCT03594162|Drug|Fludarabine|25 mg/m^2/day IV over 30 minutes administered for 3 consecutive days.
15907155|NCT03594149|Drug|Levofloxacin|Levofloxacin 500 mg/d p.o.
15907156|NCT03594136|Device|Raumedic Neurovent-P-tel|Insertion of a Neurovent-P-tel in adults to study normal intracranial pressure
15907157|NCT03594123|Drug|Brexpiprazole|2 mg tablet
15907158|NCT03594123|Drug|Brexpiprazole|3 mg tablet
15907159|NCT03594110|Drug|Empagliflozin|Taken daily with or without food
15907161|NCT03594097|Other|Treatment cookies|Plain flour, Coconut Nourish, Queen Garnet Plum, Unsalted Butter, Artificial Sweetener
15907162|NCT03594097|Other|Control cookies|Plain flour, Coconut Powder, Unsalted Butter, Artificial Sweetener, Food Colour
15907163|NCT03594071|Device|The Q-Fix™ All-Suture Anchor|Observational, post-market, clinical follow-up study
15907164|NCT03594058|Drug|Solabegron modified release tablets, low dose|Solabegron modified release tablets low dose or high dose or matching placebo once daily for 12 weeks.
15907165|NCT03594058|Drug|Solabegron modified release tablets, high dose|Solabegron modified release tablets low dose or high dose or matching placebo once daily for 12 weeks.
15907166|NCT03594058|Drug|Matching Placebo|Solabegron modified release tablets low dose or high dose or matching placebo once daily for 12 weeks.
15907167|NCT03594045|Drug|Apixaban|Apixaban is an anticoagulant that works by inhibiting the coagulation factor, Factor Xa.
15907168|NCT03594019|Procedure|Connective tissue graft|Connective tissue graft (CTG) is an oral and maxillofacial surgical procedure first described by Alan Edel in 1974. It includes the preparation the recipient site of tissue exhibiting recession by incising the gingival, obtaining the CTG from the donor site, securing the CTG at the recipient site and suturing the incised gingival tissue at both the donor and recipient sites.
15907169|NCT03594019|Procedure|socket shield technique|The procedure is used to split the teeth and preserve the buccal part
15907170|NCT03594019|Procedure|Immediate implant placement|The implant will be placed in the frest socket immediately after tooth extraction
15907171|NCT03594006|Behavioral|CCI; cancer care coordination instrument|Designed to assess cancer patients' perceptions of care coordination
15907172|NCT03593993|Procedure|Surgical Cohort|Blood, cerebrospinal fluid, and surgical tissue collected during procedure
15907173|NCT03593980|Dietary Supplement|Cranberry juice|400ml cranberry juice
15907174|NCT03593967|Behavioral|ARTISAN|"In the first four weeks, dyads will engage in museum tours facilitated by a docent from the National Museum, followed by a guided storytelling/art-making session (inspired by the artifacts in the gallery), writing activity and group sharing/debrief. The first three weeks of art making will be pair-work by the seniors and youth, while the fourth week will be a collaborative art piece that is created by all participants in the working group. In the last week, the participants will be involved in a mini-exhibition where they will share their works with the group and members of the public, and engage in guided reflection on each other's artworks.
~The main content and discussion point for each session are as follows:
~Week 1: Food and Play as our National Heritage
~Week 2: Our Voices, Our Singapore: Strengthening Bonds
~Week 3: Overcoming Adversities: Stories of Resilience
~Week 4: Beholding the Future: Dreams and Aspirations
~Week 5: Passing It On: The Stories We Share"
15907175|NCT03593954|Drug|JNJ-61393215|Participants will receive 2 oral administrations of 2 mg JNJ-61393215 as oral suspension.
15907176|NCT03593954|Drug|Ritonavir|Participants will receive 100 mg of ritonavir tablet orally.
15907177|NCT03593941|Other|Standard Diet|Participants will consume the standard diet provided in care home
15907179|NCT03593902|Drug|Rituximab|Monoclonal antibody therapy used to treat certain autoimmune diseases and types of cancer
15907180|NCT03593902|Drug|Fludarabine|A chemotherapy medication commonly used in the treatment of leukemia and lymphoma
15907181|NCT03593902|Drug|Cyclophosphamide|A medication used as chemotherapy and to suppress the immune system
15907182|NCT03593902|Drug|Mesna|A medication used in those taking cyclophosphamide or ifosfamide to decrease the risk of bleeding from the bladder
15907183|NCT03593902|Drug|rATG|A rabbit polyclonal antibody to lymphocytes
15907184|NCT03593902|Drug|Methylprednisolone|A corticosteroid medication used to suppress the immune system and decrease inflammation
15907185|NCT03593902|Drug|G-CSF|A glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream
15907186|NCT03593902|Biological|IVIg|Pooled immunoglobulin (IgG) from thousands of plasma donors that has immunomodulatory and anti-inflammatory effects
15907187|NCT03593902|Biological|Autologous Stem Cells|Infusion of patient's own stem cells
15907188|NCT03593889|Behavioral|Collaborative stepped care and peer support programme|"For at-risk group, 4 weeks of selective prevention group sessions will be provided at the elderly service level by trained peer supporters with registered social worker supervision, on wellness topics tailored to the person's concern as entry point, packaged with mental health information, followed by a review.
~For mild group, 6-8 weeks of indicated prevention with psychoeducation or low-intensity psychotherapy would be provided. For moderate group, 6-8 weeks high-intensity cognitive behavioral therapy (CBT) would be provided. All intervention for depressed elderly would be conducted by registered social workers. The trained peer supporters will be matched to individual older adults to walk them through the process with regular follow-up for 1 year."
15907189|NCT03593889|Other|Treatment as usual|The control group will receive treatment as usual, which will be determined by the responsible workers from NGO units.
15907190|NCT03593876|Behavioral|Strategy Training|This study will use an adapted form of strategy training for people with communication impairments.
15907191|NCT03593863|Behavioral|Physical Education (PE) programme|The intervention consists of a 10-month (one academic year, September-June) physical activity programme delivered by PE teachers during regular Year-8 PE lessons. The Intervention involves roughly 20 minutes of prescribed activities per week.
15907270|NCT03593304|Drug|Normal saline|Injection Normal saline(1ml) three times a week (on day 1,3,5 of vincristine chemotherapy) for 5 weeks.
15936771|NCT03367143|Drug|Ifosfamide|
15907192|NCT03593850|Behavioral|Music group|The song was composed on a C major scale and a 60 bpm tempo. The song was composed with high consonance using simple melodic progressions on the C major scale, and using natural positions for chords. No percussion or lyrics were used for the song, and the following instruments were used in the composition: electric guitar and keyboards, violin (digital), cello (digital), clarinet (digital), synthesizers (digital), and fretless bass (digital).
15907193|NCT03593850|Behavioral|Silence Group|Audio file that contained no sounds.
15907194|NCT03593837|Drug|Huang qi gui zhi wu wu granule|Patients are given HQGZWWT granules (orally twice a day for 3 months and instructed to dissolve one package (4 g) with hot water (200 mg)
15907195|NCT03593837|Drug|Huang qi gui zhi wu wu granule placebo|Patients are given HQGZWWT granules placebo (orally twice a day for 3 months and instructed to dissolve one package (4 g) with hot water (200 mg)
15907196|NCT03593824|Procedure|bilateral cataract removal surgery for dense cataract|Participants were born with dense bilateral cataracts (extreme adversity) will undergo surgery for bilateral cataract removal at an early age, mostly around 3 months of age.
15907197|NCT03593824|Procedure|bilateral cataract removal surgery for non-dense nuclear cataract|Participants were born with non-dense and nuclear bilateral cataracts (watered-down adversity) will undergo cataract removal surgery bilaterally in a compromised timing, mostly around one year old.
15907198|NCT03593811|Diagnostic Test|Questionnaires|Patients will be provide answers to one or more of the following: Rome III criteria, BARF pictorial scale, Nausea Severity scale, Children's Somatization Inventory, State-Trait Anxiety Inventory, Functional Disability Inventory, and the Nausea Interference Scale.
15907199|NCT03593811|Diagnostic Test|4 channel electrogastrogram (EGG)|EGG is a non-invasive technique for recording gastric myoelectrical activity using cutaneous electrodes placed on the abdominal skin over the stomach.
15907200|NCT03593811|Diagnostic Test|36 channel high resolution electrogastrogram (HR-EGG)|HR- EGG utilizes an array of electrodes to estimate the direction and speed of gastric slow-waves using cutaneous electrodes placed on the abdominal skin over the stomach.
15907201|NCT03593811|Diagnostic Test|Magnetogastrogram (MGG)|MGG measures spatiotemporal properties of magnetic fields from the gastric slow wave and allows characterization of the propagation of the gastric slow wave in addition to evaluation of its frequency and power distribution.
15907202|NCT03593811|Diagnostic Test|Electrocardiogram (EKG)|Electrocardiography is the process of recording the electrical activity of the heart over a period of time using electrodes placed on the skin
15907203|NCT03593811|Drug|Ondansetron|Patients will be administered 4mg or 8 mg ondansetron dependent upon age in order to assess the effect of ondansetron on the symptoms of nausea and changes in slow wave dysrhythmias.
15907204|NCT03593811|Drug|Cyproheptadine Oral Tablet|Patients will be prescribed a 5 day maintenance dose of cyproheptadine using dosing 4mg twice a day to examine the effects of pharmacological alteration of specific nausea pathways on gastric slow wave patterns in functional nausea patients
15907205|NCT03593798|Other|Lifestyle|Lifestyle intervention an effect on weight and physical capacity
15907206|NCT03593785|Drug|AZD8233|Randomized subjects will receive single SC dose of AZD8233 (dose 1, dose 2, dose 3, dose 4 and dose 5) injection.
15907207|NCT03593772|Behavioral|Mission Reconnect|This four-year randomized controlled trial with one intervention arm and one wait-list control arm will utilize mixed methods to evaluate the effectiveness and perceived value of the MR program in relation to physical and psychological symptoms, global health, and social outcomes.
15907210|NCT03593746|Other|Physical training|Type 2 diabetic patients will be subjected to different types of physical training (high intensity interval training or combined training).
15907211|NCT03593746|Other|Light-Emitting Diode (LED) therapy|Type 2 diabetic patients will be subjected to Light-Emitting Diode (LED) therapy (active or sham).
15907212|NCT03593733|Other|Photobiomodulation Therapy|Photobiomodulation Therapy
15907213|NCT03593733|Other|Cold Water Immersion|Cold Water Immersion
15907214|NCT03593720|Procedure|Measurement in Office|Penile length and glans size in 3 dimensions
15907215|NCT03593720|Procedure|Measurement in OR|Penile length and glans size in 3 dimensions
15907216|NCT03593707|Drug|Metformin|Metformin
15907217|NCT03593707|Drug|PF-06865571|PF-06865571
15907218|NCT03593694|Behavioral|TECH DM-BAT|Multi-component, high intensity intervention, technology delivered, diabetes-modified behavioral activation treatment.
15907219|NCT03593694|Behavioral|TECH DMBAT Active Comparator|Technology delivered diabetes education and home tele monitoring
15907220|NCT03593694|Behavioral|TECH DMBAT Other|Technology delivered diabetes education
15907221|NCT03593681|Device|Hysteroscopic cell sampling of the fallopian tube|Hysteroscopic fallopian tube biopsy
15907222|NCT03593668|Drug|Metformin|"2-week dose adjustment period（0-2weeks）[before meals] 0-2d： - ;250mg，po; -. 3-4d： - ;250mg，po; 250mg，po. 5-6d： 250mg，po; 250mg，po; 250mg，po. 7-9d: 250mg，po; 500mg，po; 250mg，po. 10-11d: 250mg，po; 500mg，po; 500mg，po. 12-14d: 500mg，po; 500mg，po; 500mg，po.
~10-week dose stabilization period（3-12weeks） Metformin Hydrochloride Tablet 500mg tid po."
15907223|NCT03593668|Drug|Benaglutide|"2-week dose adjustment period（0-2weeks） [before meals] 0-2d: -; 0.1mg，iH; -; 3-4d: -; 0.1mg，iH; 0.1mg，iH; 5-6d: 0.1mg，iH; 0.1mg，iH; 0.1mg，iH; 7-9d: 0.1mg，iH; 0.2mg，iH; 0.1mg，iH; 10-11d: 0.1mg，iH; 0.2mg，iH; 0.2mg，iH; 12-14d: 0.2mg，iH; 0.2mg，iH; 0.2mg，iH.
~10-week dose stabilization period（3-12weeks） Benaglutide Injection 0.2mg，100ul，tid，iH"
15907224|NCT03593655|Device|Dapivirine vaginal ring|Vaginal ring containing 25 mg of dapivirine
15907225|NCT03593655|Drug|FTC/TDF|Tablet containing 200 mg FTC/300 mg TDF
15907226|NCT03593642|Drug|Continuous infusion of ropivacain in ESP catheter|administration of ropivacaine in ESP catheter to provide regional analgesia after surgery
15907227|NCT03593642|Drug|Continuous infusion of Iso Saline in ESP catheter|administration of Iso Saline in ESP catheter to be the control group
15907271|NCT03593304|Drug|Oral Placebo|Placebo Oral Tablet (25 mg) 2 tablets thrice daily for 5 weeks.
15907230|NCT03593616|Procedure|Phacoemulsification|insertion of intra-ocular lens after emulsification of catractous lens
15907231|NCT03593603|Device|Nellcor™ Bedside Respiratory Monitoring System|Nellcor™ Bedside Respiratory Patient Monitoring System with Nellcor™ Respiration Rate Software and the Nellcor™ Adult Respiratory Sensor to provide continuous respiration rate monitoring
15907233|NCT03593564|Behavioral|KINDER|KINDER is an online course for people assisting an older adult with dementia. It is intended to improve the quality of caregiver's relationship with the care recipient and reduce the chance of risky relationship behavior (e.g., yelling). Courses will cover topics including understanding cognitive impairments, navigating evolving roles, and dealing with frustration. During this course, participants will learn skills to deal with difficult situations caregivers frequently encounter in ways that support a healthy caregiving relationship. Videos will be story-based and represent different types of caregiving relationships and challenges encountered.
15907234|NCT03593551|Combination Product|five relaxation treatments and one control|Five treatments are relaxation meditation tape, music tape, relaxation lighting, meditation tape plus lighting, and music plus lighting. The control session have no intervention, participants will just be asked to sit comfortably for 10 minutes.
15907235|NCT03593538|Drug|Metformin|Metformin capsule
15907236|NCT03593538|Drug|Placebo|Sucrose filler in gel capsules
15907237|NCT03593525|Other|SPARK|see above
15907238|NCT03593512|Procedure|Deep brain stimulation|Bilateral deep brain stimulation of the pedunculopontine nucleus
15907239|NCT03593499|Drug|omaveloxolone|
15907240|NCT03593486|Device|Low-level Pulsed EMF|Low-level pulsed electromagnetic field stimulator delivered through a Helmholtz coil positioned around the participant's head and neck. Stimulation parameters are 0.032 µG at 0.89 Hz for 60 minutes.
15907241|NCT03593486|Device|Sham Stimulation|The stimulator will be placed around the participant's head and neck, but no EMF will be delivered.
15907242|NCT03593473|Drug|Intranasal Oxytocin|Six intranasal sprays of oxytocin. Each insufflation delivers 4 IUs of oxytocin for a total oxytocin dosage of 24 IUs.
15907243|NCT03593473|Drug|Placebo|Six intranasal sprays of placebo manufactured to mimic oxytocin nasal spray containing all equivalent ingredients except oxytocin.
15907244|NCT03593460|Drug|Synthetic PreImplantation Factor|peptide
15907245|NCT03593447|Drug|non-cirrhotic subjects. low TG-2349+ low DAG181+Ribavirin|Group1: TG-2349 200 mg + DAG181 100 mg + Ribavirin 1000 mg or 1200 mg
15907246|NCT03593447|Drug|non-cirrhotic subjects. high TG-2349+ high DAG181+Ribavirin|Group2: TG-2349 400 mg + DAG181 200 mg + Ribavirin 1000 mg or 1200 mg
15907247|NCT03593447|Drug|non-cirrhotic subjects. low TG-2349+ low DAG181|Group 3: TG-2349 200 mg + DAG181 100 mg
15907248|NCT03593447|Drug|non-cirrhotic subjects. high TG-2349+ high DAG181|Group 4: TG-2349 400 mg + DAG181 200 mg
15907249|NCT03593447|Drug|cirrhotic subjects. high TG-2349+ high DAG181+Ribavirin|Group 5: TG-2349 400 mg + DAG181 200 mg + Ribavirin 1000 mg or 1200 mg_
15907250|NCT03593447|Drug|cirrhotic subjects. high TG-2349+ high DAG181|Group6: TG-2349 400 mg + DAG181 200 mg
15907251|NCT03593434|Drug|hyperpolarized Xenon gas|This present study will utilize existing study visits for the NHLBI study, with patients opting-in to have all of the procedures performed twice, with an intervening ACT, during one their study visits.
15907252|NCT03593421|Drug|synthetic PreImplantation Factor|peptide
15907253|NCT03593408|Drug|Dexmedetomidine|Administered for sedation management per hospital protocol
15907254|NCT03593408|Drug|Fentanyl|Administered for sedation management per hospital protocol
15907255|NCT03593408|Drug|Midazolam|Administered for sedation management per hospital protocol
15907256|NCT03593408|Drug|Morphine|Administered for sedation management per hospital protocol
15907257|NCT03593395|Other|Peer Mentoring [PM]|Virtual Peer Mentoring in addition to Structured Education Transition QI
15907258|NCT03593395|Other|Structured Education Based Transition Program STE|Education-based program without Peer Mentoring
15907259|NCT03593369|Device|KLOX BioPhotonic System (single treatment)+SOC|"KLOX BioPhotonic system (composed of LumiHeal Gel and KT-L Lamp). In this study arm one treatment will be assessed - two visits per week.
~Standard of Care (SOC) for wound healing will be administered during the treatment and follow-up periods (20 weeks)."
15907260|NCT03593369|Device|KLOX BioPhotonic System (consecutive treatments)+SOC|"In this study arm, two consecutive treatments during the same visit will be evaluated- two visits for the first two weeks, then one visit per week.
~Standard of Care (SOC) for wound healing will be administered during the treatment and follow-up periods (20 weeks)."
15907261|NCT03593369|Other|Standard of Care (SOC)|Standard of Care (SOC) for wound healing will be administered during the treatment and follow-up periods (20 weeks).
15907262|NCT03593356|Behavioral|Monthly cash gift payments of $333|These subjects receive $333 each month for 52 months via debit card.
15907263|NCT03593356|Behavioral|Monthly cash gift payments of $20|These subjects receive $20 each month for 52 months via debit card.
15907264|NCT03593343|Behavioral|Overnight fasting duration|Subjects will adhere to overnight fasting protocol for 6 days
15907265|NCT03593330|Other|Transitional Care Programme|These patients will receive a pre-admission overview of their surgery, an anticipated discharge date, and a pre-scheduled discharge appointment to set patient expectations for a shorter hospitalization. On the day of discharge, the patient and his or her caregiver will attend an extended discharge appointment with a TCP-trained nurse. Finally, patients will receive a surveillance phone call 48 hours after discharge.
15907266|NCT03593317|Drug|Spironolactone|The doses used in the study are the doses used in standard clinical practice. Initial dose is 25 mg/day until study end . The duration of treatment for each patient is 36 months.
15907267|NCT03593317|Drug|Placebo|Placebo will be taken once a day at the same time of day. The duration of treatment for each patient is 36 months.
15907268|NCT03593304|Drug|Injection Mecobalamin|Injection Mecobalamin (500mcg) three times a week (on day 1,3,5 of vincristine chemotherapy) for 5 weeks.
15907269|NCT03593304|Drug|Tablet Pyridoxine hydrochlorid|Tablet Pyridoxine hydrochloride (25 mg) 2 tablets thrice daily for 5 weeks.
15907273|NCT03593278|Drug|ACT-246475|Single s.c. dose of 16 mg ACT-246475 including 3.7 MBq (100 μCi) 14C-radiolabeled ACT 246475
15907274|NCT03593265|Other|MUNIX|Motor unit number index in 4 muscles: tibialis anterior, abductor digiti mini, abductor pollicis brevis et deltoideus
15907275|NCT03593252|Drug|Senna|Laxative,used for bowel preparation
15907276|NCT03593252|Drug|Sodium Picosulfate, Magnesium Oxide and Citric Acid|Laxative used for bowel preparation
15907277|NCT03593252|Drug|Erythromycin|Oral non-absorbable antibiotic
15907278|NCT03593252|Drug|Kanamycin|Oral non-absorbable antibiotic
15907279|NCT03593252|Drug|Cefazolin|Intravenous antibiotic to be given on anesthesia induction and prior to incision as a prophylactic antibiotic.
15907280|NCT03593252|Drug|Metronidazole|Intravenous antibiotic to be given on anesthesia induction and prior to incision as prophylactic antibiotic.
15907281|NCT03593252|Other|Nil per os|Fasting orders according to anesthesia prior to surgery: No solid for >=8 hours, no formula milk/full liquids >= 4hours; no breast milk or clear fluids >=2hours.
15907282|NCT03593239|Other|Tobacco flavored JUUL 1.7% ENDS|Treatment with Tobacco flavored JUUL 1.7% ENDS (10 puffs)
15907283|NCT03593239|Other|Tobacco flavored JUUL 5% ENDS|Treatment with Tobacco flavored JUUL 5% ENDS(10 puffs)
15907284|NCT03593239|Other|Mint flavored JUUL 1.7% ENDS|Treatment with Mint flavored JUUL 1.7% ENDS(10 puffs)
15907285|NCT03593239|Other|Mint flavored JUUL 5% ENDS|Treatment with Mint flavored JUUL 5% ENDS(10 puffs)
15907286|NCT03593239|Other|Fruit Medley flavored JUUL 1.7% ENDS|Treatment with Fruit Medley flavored JUUL 1.7% ENDS(10 puffs)
15907287|NCT03593239|Other|Fruit Medley flavored JUUL 5% ENDS|Treatment with Fruit Medley flavored JUUL 5% ENDS(10 puffs)
15907288|NCT03593239|Other|Crème brulee flavored JUUL 1.7% ENDS|Treatment with Crème brulee flavored JUUL 1.7% ENDS(10 puffs)
15907289|NCT03593239|Other|Crème brulee flavored JUUL 5% ENDS|Treatment with Crème brulee flavored JUUL 5% ENDS(10 puffs)
15907290|NCT03593239|Other|JUUL 1.7% ENDS 10 puffs vs. ad lib puffs|Treatment with JUUL 1.7% ENDS 10 puffs vs. ad libitum puffs
15907291|NCT03593239|Other|JUUL 5% ENDS 10 puffs vs. ad lib puffs|Treatment with JUUL 5% ENDS 10 puffs vs. ad libitum puffs
15907292|NCT03593226|Drug|AGI-134|AGI-134 via IT injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles.
15907293|NCT03593213|Drug|Cariprazine|Cariprazine capsules, oral administration, once daily.
15907294|NCT03593213|Drug|Placebo|Matching placebo capsules, oral administration, once daily.
15907295|NCT03593200|Drug|Pegcetacoplan|Complement (C3) Inhibitor
15907296|NCT03593187|Drug|Cal-1 (LVsh5/C46) drug product|Autologous CD34+ Haematopoietic Stem/Progenitor Cells and CD4+ T Lymphocytes Transduced with LVsh5/C46, a Dual Anti-HIV Gene Transfer Construct
15907297|NCT03593174|Device|Ossur Rigid Dressing|Removable Rigid Dressing
15907298|NCT03593174|Device|Elastic Bandage|Usual modality: Elastic bandage
15907299|NCT03593161|Behavioral|Humor therapy|Clown visits
15907300|NCT03593148|Other|Lifestyle|Lifestyle treatment
15907301|NCT03593135|Dietary Supplement|Apple Cider Vinegar and tablet Tagipmet (Metformin + Sitagliptin group)|15ml apple cider vinegar (American garden organic vinegar) (containing 5% acetic acid) mixed in 200ml water during meal at night time, for 3 months and tablet Tagipmet 50mg/1000mg (Metformin + Sitagliptin group) twice a day. NOTE medical treatment is our inclusion criteria.
15907302|NCT03593135|Other|Water with Apple Cider vinegar flavor and tablet Tagipmet (Metformin + Sitagliptin group)|Flavor of apple cider vinegar in 200 ml water is added and given to have a placebo effect and tablet Tagipmet 50mg/1000mg (Metformin + Sitagliptin group) twice a day. NOTE medical treatment is our inclusion criteria.
15907303|NCT03593122|Device|WO2085 Moisturising Cream|"Week 1: 2.5 g of the investigational product WO2085 Moisturising Cream will be applied intravaginally, once daily in the evening. In addition 0.5 g (1 fingertip unit) may be applied to the outer genital area as needed (also several times per day).
~Week 2-4: The frequency may be reduced by the patient as needed. In addition 0.5 g (1 fingertip unit) may be applied to the outer genital area as needed (also several times per day)."
15907304|NCT03593109|Drug|Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy|Patients will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of CAR-T cells. After a pre-treatment lymphodepletion therapy, patients will receive the Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy by intravenous injection.
15907305|NCT03593096|Other|Assessment at Low Altitude (470m above sea level)|Assessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure
15907306|NCT03593096|Other|Exposure to High Altitude (2500m above sea level)|Exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hours
15907307|NCT03593083|Other|Low altitude: 470m above sea level|Assessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure
15907308|NCT03593083|Other|Säntis; 2500m above sea Level|Exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hours
15907309|NCT03593070|Behavioral|Chronic Grief Management Intervention-Video|The CGMI-V participant manual will be provided to participants either mailed or emailed. We will mail hard copies of the manual to caregivers who prefer them over the e-format. The technology assistant will review with each participant the use of technology Cisco WebEx and iPads) via e-mailed step-by-step written instructions and over-the-phone conferencing. Group sessions will take place using WebEx (an internet platform providing video connection) and iPads, at mutually agreed-upon times and days of the week. All group sessions will be audio and video-recorded for fidelity purposes, with caregivers' approval documented in the informed consent. The interventionists will label each recorded meeting group identification number, session number, and date.
15907310|NCT03593057|Other|Manual therapy|Manual therapy protocol and self-care advice and body awareness.
15907311|NCT03593057|Other|Control group|Advice on self-care and body awareness.
15907312|NCT03593044|Drug|0.01% concentration atropine drops|One drop of 0.01% concentration atropine in each eye at night for seven days.
15907313|NCT03593031|Behavioral|Office Based Vergence and Accommodative Therapy|Exercises that will stimulate disparity vergence or accommodation independently and then combined will be used.
15907314|NCT03593018|Drug|Oral azacitidine|Azacitidine tablets
15907315|NCT03593018|Drug|Romidepsin|Romidepsin injection
15907318|NCT03593005|Other|Assessment at Low Altitude (470m above sea level)|Assessment at Low Altitude (in Zurich; 470m above sea level) in order to compare this data with High altitude exposure
15907319|NCT03593005|Other|Exposure to High Altitude (2500m above sea level)|Exposure to High Altitude (Säntis; 2500m above sea level) for approximately 5 hours
15907320|NCT03592992|Drug|Spinal Hydromorphone|75 mcg of hydromorphone will be prepared in a non-identifiable syringe by central hospital pharmacy. The resulting solution will then be added to the spinal anesthetic mixture(fentanyl 15 mcg and 0.75% hyperbaric bupivacaine 1.4-1.6 mcg at the discretion of the attending anesthesiologist, adjusted to height and weight)
15907321|NCT03592992|Drug|Spinal Morphine|150 mcg of morphine will be prepared in a non-identifiable syringe by central hospital pharmacy.The resulting solution will be added to the spinal anesthetic mixture (fentanyl 15 mcg and 0.75% hyperbaric bupivacaine 1.4-1.6 mcg at the discretion of the attending anesthesiologist, adjusted to height and weight)
15907322|NCT03592979|Device|Simulated Altitude: (FiO2: 15.1)|"Inhalation of deoxygenated air through an altitude simulator (Altitrainer) for approximately 1 hour given by a facemask."
15907323|NCT03592979|Device|Shamed Hypoxia (FiO2: 20.9)|"Inhalation of unmodified air through an altitude simulator (Altitrainer) for approximately 1 hour given by a facemask."
15907324|NCT03592966|Dietary Supplement|Wild Blueberry Powder|Freeze-dried whole fruit blueberry drink.
15907325|NCT03592966|Dietary Supplement|Placebo|Freeze-dried placebo powder
15907326|NCT03592953|Other|Serious game simulation training sessions|"Each participant of the Serious game groups played 3 scenarios of Perinatsims, a screen-based simulation on the management of a post partum hemorrhage. The serious game control group played basic scenarios and the experimental group played specific scenarios."
15907327|NCT03592940|Dietary Supplement|Mediterranean diet|We aim to determine the effects of the traditional Mediterranean Diet on neuroendocrine tumours
15907328|NCT03592927|Device|Simulated Altitude (FiO2: 15.1%)|"Inhalation of deoxygenated air through a altitude simulator (Altitrainer), for approx. 1 hour. given by a facemask."
15907329|NCT03592927|Device|Shamed Hypoxia (FiO2: 20.9)|"Inhalation of unmodified air through an altitude Simulator (Altitrainer) for approximately 1 hour given by a facemask"
15907330|NCT03592901|Drug|brachial plexus anesthesia|Anesthesia to some part of the brachial plexus prior to surgery. Patients are already receiving this regardless of participation in study.
15907331|NCT03592888|Drug|mDC3/8-KRAS Vaccine|Mature dendritic cell (mDC3/8) vaccine (primer and booster) in subjects with resected pancreatic adenocarcinoma
15907332|NCT03592875|Behavioral|Professional nurses|The nurses will be interviewed by a semi-structured guiding with 16 questions addressing aspects related to Nursing Care Systematization knowledge and practices.
15907333|NCT03592862|Drug|HTL0018318|Oral capsule
15907334|NCT03592862|Drug|Placebo|Oral capsule
15907335|NCT03592849|Procedure|UC-MSCs therapy|After history taking, physical examination, ultrasound examination and hysteroscopy examination，infertile women diagnosed with thin endometrium or endometrial scarring will be included in the clinical trial. A collagen scaffold loaded with UC-MSCs will be transplanted into the uterine cavity during hysteroscopy, and participants will receive hormone replacement therapy before and after the treatment. Postoperative observations including ultrasound examination once a month for 3 times and hysteroscopy in the third month after first UC-MSCs therapy. Those whose endometrium is suitable for pregnancy will be recommended attempting conception actively. The next round of cell therapy will be conducted 3 cycles after the first month if the endometrial growth is unsatisfactory.
15907336|NCT03592836|Drug|Loop Diuretics|intravenous administration of diuretics
15907337|NCT03592823|Drug|Hydroxychloroquine Sulfate 200 Mg Tablet|200 mg, bidpo.
15907338|NCT03592810|Other|Settings of the extracorporeal membrane oxygenation (ECMO)|Compare the settings of the ECMO in different European hospitals and relate them to cerebral saturation and neurological outcome, using Cerebral Performance Category (CPC) score
15907339|NCT03592797|Other|Laser acupuncture therapy|Low level laser therapy to stimulate acupuncture points: Total 11 points will be used in the study. 7 points ST4, ST6, ST7, SI18, BL2, GB14, SJ17 located in the effected side of the face and will be stimulated ipsilateral. Two points ST36, LI4 located distally and will be stimulated bilateral.
15907340|NCT03592797|Other|Sham laser acupuncture therapy|Sham procedure of Low level laser therapy to stimulate acupuncture points is identical procedure as the intervention group. The same 11 points which mention above will be used, However, in the sham group the laser device will be deactivated and won't produce any laser beam irradiation.
15907341|NCT03592784|Behavioral|Food Order Therapy|Instructing patient to, whenever possible, eat carbohydrates at the end of their meal.
15907342|NCT03592784|Behavioral|Medical Nutrition Therapy|Key components of this therapy include counseling to incorporate portion control, increased intake of vegetables and low glycemic index carbohydrates, and mild carbohydrate restriction.
15907343|NCT03592771|Behavioral|Prompts to report adherence and symptoms via study app|Text message prompts to report medication adherence and symptoms via the web-enabled study app Weekly prompts to report AET use in the previous 7 days and treatment-related adverse symptoms via the web-enabled study app. All participant-reported data will be automatically entered into the patient's electronic health record and easily available to the care team for review. Any concerning symptoms or changes will trigger an email alert to the patient's oncology team.
15907344|NCT03592771|Behavioral|Feedback messages|Participants will receive weekly tailored feedback messages and/or images.
15907345|NCT03592745|Device|Transcutaneous Vagus Nerve Stimulation (tVNS)|tVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear.
15907346|NCT03592745|Device|Sham Transcutaneous Vagus Nerve Stimulation (tVNS)|tVNS is a non-invasive form of vagus nerve stimulation, activating the auricular branch of the vagus nerve transcutaneously through the cymba concha at the pinna of the ear. Sham tVNS means the patient is wearing the device, but it is turned off and not delivering current during the treatment. This is a placebo condition, which is used as a study control.
15907347|NCT03592732|Other|Blood sample|Blood sample
15907348|NCT03592719|Behavioral|Experimental Intervention (MI-PrEP)|The experimental intervention will consist of two sessions. The first session will involve psycho-education on PrEP and Motivational Interviewing to explore ambivalence about PrEP uptake. The second session will involve Motivational Interviewing and case management to explore barriers to accessing PrEP.
15907349|NCT03592719|Behavioral|Enhanced Treatment as Usual (E-TAU)|Participants assigned to the control condition will receive two sessions, both of which involve psychoeducation on PrEP.
15907350|NCT03592706|Biological|IKC (Immune Killer Cells)|
15907351|NCT03592706|Procedure|TACE (Transcatheter Arterial Chemoembolization)|
15907352|NCT03592693|Drug|Combined Vitamin C and Stress-Dose Hydrocortisone|Treatment of septic shock with vitamin C and stress-dose hydrocortisone aimed at the attenuation of the systemic inflammatory response and the improvement of vasopressor responsiveness.
15907353|NCT03592693|Drug|Placebo plus placebo|Treatment of septic shock with placebo (corresponding to Vitamin C) and placebo (corresponding to hydrocortisone).
15907354|NCT03592680|Dietary Supplement|Vitamin C|1 gram Vitamin C will be administrated orally, twice a day from 5 days before until 10 days after surgery.
15907355|NCT03592680|Other|Placebo|1 gram Placebo will be administrated orally, twice a day, from 5 days before until 10 days after surgery
15907356|NCT03592667|Drug|Dapagliflozin|10 mg, one per day before breakfast during 12 weeks.
15907357|NCT03592667|Drug|Placebo - Cap|One per day before breakfast during 12 weeks.
15907358|NCT03592654|Behavioral|infant telehelp|Adapted from Early Start Denver Model (ESDM), a naturalistic developmental behavioral intervention
15907359|NCT03592641|Drug|Savolitinib|Given PO
15907360|NCT03592628|Other|Visual Aid|The visual aid was a one-sheet diagram with illustrations of important features of post-cesarean wound care.
15907361|NCT03592628|Other|Standard Instructions|Standard discharge instructions WITHOUT supplement of visual aid.
15907362|NCT03592615|Procedure|cataract surgery|Cataract surgery in this study is only for the purpose of vision correction, not for the treatment of ocular pathology other than cataract, e.g., treatment for lens dislocation. The surgery used in this study should not be combined with other procedures, such as limbal relaxing incision for treating astigmatism.
15907363|NCT03592615|Procedure|Corneal refractive surgery|Corneal refractive surgery in this study is only for the purpose of vision correction, not for the treatment of ocular pathology other than refractive error, e.g., treatment for corneal scar. The surgery used in this study should not be combined with other procedures, such as limbal relaxing incision for treating severe astigmatism.
15907364|NCT03592602|Procedure|arm abduction and adduction|All PICC lines will be placed under the guidance of intravascular ECG. Before the PICC placement procedure, basal ECG will be examed. During the procedure, intravascular ECG data will be collected with the punctured arm adduction and abduction while the catheter advances to the cavoatrial junction. After the procedure, chest X-ray radiographs will be taken with arms 90° abducted and adducted (i.e., 0°abducted) in a supine position.
15907365|NCT03592589|Device|high flow nasal canula|high flow nasal canula to obtain a positive expiratory pressure
15907366|NCT03592576|Drug|Navitoclax|Tablet, Oral
15907367|NCT03592576|Drug|Venetoclax|Tablet, Oral
15907368|NCT03592563|Behavioral|Neuro-QoL questionnaire|Follow-up over time will continue (either in-person or over the phone) using the same questionnaires (depending on which group they are belongs to) at approximately 6-month intervals. During each follow-up, participants will be screened for any new signs, symptoms and diagnoses of neurological and/or psychiatric disorders, in order to correlate these outcomes with risk factors captured using the procedures described above.
15907369|NCT03592550|Device|Ultrasound imaging|Abdominal ultrasound imaging of the liver
15907370|NCT03592537|Drug|Fentanyl|The study drugs will be prepared by an anesthesiologist not involved in performing the anesthesia patient care or in data collection. Children will be randomly allocated into three groups of 30 children
15907371|NCT03592537|Drug|Midazolam|The study drugs will be prepared by an anesthesiologist not involved in performing the anesthesia, patient care, or in data collection. Children will be randomly allocated into three groups of 30 children
15907372|NCT03592537|Drug|Bupivacaine Hydrochloride|The study drugs will be prepared by an anesthesiologist not involved in performing the anesthesia, patient care, or in data collection. Children will be randomly allocated into three groups of 30 children
15907373|NCT03592524|Behavioral|Fasting Ramadan|Muslims recipients refrain from eating and drinking anything from dawn until sunset(14-15 hours)
15907374|NCT03592511|Dietary Supplement|WGPF-burger|Volunteers consumed a WGPF-burger daily
15907375|NCT03592511|Dietary Supplement|Control-burger|Volunteers consumed a Control-burger daily
15907376|NCT03592498|Drug|Sulfadiazine, Silver|Application of silver sulfadiazine ointment, bandage covered with gauze and bandage.
15907377|NCT03592498|Device|Skin of Nile tilapia|Application of skin of Nile tilapia (Oreochromis niloticus), as a biological occlusive dressing.
15907378|NCT03592485|Procedure|Erector Spinae Plane blockade|Before the beginning of the procedure, ESP blockade will be performed under ultrasound control. A single-shot technique will be used with 0.375 % solution of ropivacaine: 0.1 mL per patients' KG. The maximum dose is 20 mL.
15907379|NCT03592485|Procedure|Pectoral Fascia block|Before the beginning of the procedure, PECS type I and II blocks will be performed under ultrasound control. A single-shot technique will be used with 0.375 % solution of ropivacaine: 0.1 mL per patients' KG. The maximum dose is 20 mL.
15907380|NCT03592485|Drug|Oxycodone|Each patient, before the end of surgery, will be administered i.v. 0.1 mg of oxycodone. PCA with oxycodone (1mg/mL) will be utilized during the postoperative period: 5-minute interval.
15907381|NCT03592485|Procedure|general anesthesia|Each patient will generally anesthetized and endotracheal tube will be inserted
15907382|NCT03592485|Drug|paracetamol|Paracetamol will be given i.v. every 6 hours.
15907383|NCT03592472|Drug|Pazopanib|All patients will receive pazopanib at a starting dose of 800 mg by mouth (p.o.) daily on Days 1 to 28 of each treatment cycle. Patients should be instructed to take their once- daily oral dose of pazopanib at the same time each morning. Each dose of pazopanib should be taken with an 8 oz/240 mL glass of water either 1 hour before or 2 hours after a meal. Patients should be instructed to swallow the tablets whole and not chew them.
15907384|NCT03592472|Drug|Abexinostat|The starting dose and schedule of abexinostat will be 80 mg p.o. BID on Days 1 to 4, 8 to 11, and 15 to 18 of every 28-day cycle, 2 doses 4 hours apart. Each dose of abexinostat should be taken with an 8 oz/240 mL glass of water at least half an hour before meals or more than 2 hours after a meal and must be 4 hours apart. Patients should be instructed to swallow the tablets whole and not chew them.
15907427|NCT03592147|Other|Guided Imagery Relaxation Tape|The meditation is approximately 7 minutes in duration.
15907385|NCT03592472|Other|Placebo|The starting dose and schedule of abexinostat matching placebo will be 80 mg p.o. BID on Days 1 to 4, 8 to 11, and 15 to 18 of every 28-day cycle, 2 doses 4 hours apart. Each dose of placebo should be taken with an 8 oz/240 mL glass of water at least half an hour before meals or more than 2 hours after a meal and must be 4 hours apart. Patients should be instructed to swallow the tablets whole and not chew them.
15907386|NCT03592459|Device|Macy Catheter|Undergo placement of Macy catheter
15907387|NCT03592459|Procedure|Pain Therapy|Receive opioids via Macy catheter
15907388|NCT03592459|Other|Questionnaire Administration|Ancillary studies
15907389|NCT03592459|Other|Survey Administration|Ancillary studies
15907390|NCT03592446|Device|Transcutaneous electrical vagus nerve stimulation|All subjects receive electrical VNS stimulation at cymba conchae.
15907391|NCT03592446|Device|Sham vagus nerve stimulation|All subjects receive electrical stimulation at earlobe.
15907392|NCT03592433|Behavioral|I Can PIC|Participants will be shown (on a computer or via email link) a website called I Can PIC. I Can PIC provides health insurance education, suggests ways to learn about the costs of cancer care and follow-up, shows resources to help offset the high costs of care, and helps individuals estimate (based on national data) how much they might spend on health insurance in the upcoming year.
15907393|NCT03592420|Behavioral|Interdisciplinary multicomponent interventions|
15907394|NCT03592420|Behavioral|Usual care|standard care
15907395|NCT03592407|Drug|Epacadostat|Given PO
15907396|NCT03592407|Other|Laboratory Biomarker Analysis|Correlative studies
15907397|NCT03592407|Biological|Pembrolizumab|Given IV
15907398|NCT03592407|Other|Pharmacodynamic Study|Correlative studies
15907399|NCT03592394|Device|Immersive Virtual Reality (Gear VR)|Immersing the user in a total visual environment.
15907400|NCT03592381|Procedure|Ridge Expansion by ossedensification|Osseodensification is a new concept facilitated by Densah® Burs which are a multi- fluted osteotome like drilling instrumentsThe idea behind the technique is using a non-subtractive drilling mode that preserves bone and increases its density along the osteotomy walls instead of cutting it away (Huwais and Meyer 2015)
15907401|NCT03592381|Procedure|ridge expansion by ridge splitting|using the piezotome,Piezoelectric ridge splitting allows exact, clean, and smooth even curved cutting of the bone tissue, with proper visibility.
15907402|NCT03592368|Device|IBT|Interpretation bias training
15907403|NCT03592355|Other|Virtual Visit|Clinicians will have a synchronous video visit with their patients.
15907404|NCT03592342|Drug|Clobetasol Propionate|Rivelin® patch is a two-layer patch comprised of a muco-adhesive, drug-delivery layer and a protective layer.
15907405|NCT03592329|Behavioral|Stress Reduction Training A|"twice weekly booster sessions and weekly instructor-led sessions for 8 weeks plus home practice sessions"
15907406|NCT03592329|Device|active tVNS|non-painful electrical stimulation of the auricle
15907407|NCT03592329|Behavioral|Stress Reduction Training B|"twice weekly booster sessions and weekly instructor-led sessions for 8 weeks plus home practice sessions"
15907408|NCT03592329|Device|sham tVNS|sham stimulation
15907409|NCT03592316|Other|Lower Extremity Amputation Pathway|"Pre-operatively: Subjects will meet with social work/case management, physical therapy, anesthesiology, and the prosthetist for the following: discuss expectations and rehabilitation; pain control options and consideration for epidural or nerve block; prosthetic treatment and care timeline.
~Post-operatively: Physical therapy will begin on post-op day 1 with increasing complexity through post-op day 3. On post-op day 3 the wound will be examined by the surgeon and subjects will be cleared for discharge.
~Quality of life surveys will be given at several time points during post-operative care."
15907410|NCT03592290|Diagnostic Test|Lower body negative pressure|We will be monitoring the changes in central and peripheral monitors/waveforms during gradual hypovolemia induced by lower body negative pressure in healthy volunteers.
15907411|NCT03592277|Drug|Vitamin C|Patients will receive 1.5g of vitamin C in 100mL of 0.9% sodium chloride (normal saline) every six hours for four days or until discharge from the ICU, whichever happens first (seventeen dose maximum).
15907412|NCT03592277|Drug|Vitamin B1|Patients will also receive 200 mg of IV vitamin B1 every 12 hours in 50 mL of normal saline for four days or until ICU discharge (whichever happens first, nine dose maximum).
15907413|NCT03592264|Drug|OBI-3424|liquid formulation for Intravenous infusion
15907414|NCT03592251|Dietary Supplement|Olive Oil Placebo|6 months placebo supplementation
15907415|NCT03592251|Dietary Supplement|EPA-rich|6 months placebo supplementation
15907416|NCT03592251|Dietary Supplement|DHA-rich|6 months placebo supplementation
15907417|NCT03592238|Other|Aerobic Exercise Intervention|The protocol will include a 25-min bout of exercise at an intensity of 75% HRmax, such that participants will engage in a 1-min warm up and a 1-min cool down, with the majority of time (i.e., 23-min) spent exercising at 75% of HRmax.
15907418|NCT03592238|Other|Trier Social Stress Test for Children|Participants will be asked to imagine that they are in a new class with 20 other students, and that their teacher has asked them to stand in front of the class and introduce themselves. The mental arithmetic task will entail asking children to serially subtract the number 5 from a larger number as quickly as possible.
15907419|NCT03592238|Other|Seated Rest|Children will be asked to sit quietly or read a book of their choosing.
15907420|NCT03592225|Behavioral|Educational workshop|the intervention is a 3 hours educational workshop designed to address all the potential questions that the general practitioners (GP) and their patients might have regarding HPV vaccination.
15907421|NCT03592212|Drug|Salbutamol|Measurement of bronchodilator response (BDR)
15907422|NCT03592199|Drug|Sunitinib|1st line sunitinib on a 4/2 schedule followed by axitinib 5 mg twice a day on 2nd line therapy
15907423|NCT03592186|Behavioral|Parenting Wisely+|Parenting Wisely+ experimental intervention
15907424|NCT03592186|Behavioral|Treatment as Usual|Treatment as Usual
15907425|NCT03592173|Diagnostic Test|Paired TMS & Peripheral Nerve Stimulation|Method of assessing neurophysiology and activity of the spinal cord
15907426|NCT03592160|Other|Physiotherapy treatment|Physiotherapy treatment consisted of pelvic floor exercises assisted by manometric biofeedback. In addition, active lumbopelvic stabilization exercises, including the contraction of pelvic floor muscles was performed in supine, plank and quadruped position.
15936772|NCT03367143|Drug|Carboplatin|
15907428|NCT03592147|Other|Music Listening|Participants have the option of selecting one of the following music categories: New age, classical, and oriental. The songs were selected based on criteria established in a previous study to induce relaxation. All songs were also modified in length to be approximately 7 minutes in duration.
15907429|NCT03592147|Other|Relaxation Lighting|The participants were asked to select either orange or blue lighting settings using the Philips Hue lighting. The intensity of the light will be fixed to control for that measure. They were asked to sit for approximately 7 minutes in duration.
15907430|NCT03592147|Other|Meditation and Relaxation Light|The guided imagery meditation and relaxation lighting were combined.
15907431|NCT03592147|Other|Music and Relaxation Light|The music and relaxation lighting were combined.
15907432|NCT03592147|Other|Control/Silence|The participants were asked to relax for a duration of 7 minutes, with no explicit advice given. Lighting was adjusted to a specific intensity and colour (basic yellow light) as was used in the music and guided imagery interventions.
15907433|NCT03592134|Other|esophageal pressure measurement|Measurement of esophageal pressure to determine the optimal non invasive respiratory support
15907434|NCT03592121|Drug|AB-101|Apply approximately 1 hour prior to sexual activity
15907435|NCT03592121|Drug|Placebo|Apply approximately 1 hour prior to sexual activity
15907436|NCT03592108|Other|CSR remote monitoring|The intervention will consist to modify the method used to analyse the data collected by remote monitoring in OSA-patients treated by CPAP (device : AirSense™10 Autoset™, ResMed) in order to alert physicians when Cheynes-Stokes respiration (CSR) occurs during sleep and then to set up emergency pulmonology and cardiology consultations to screen the onset of a significant cardiac event (heart failure, rhythm disorder, diastolic dysfunction).
15907437|NCT03592095|Device|Dry needling|Real dry needling will be conducted according to Hong description, fast-in and fast-out interventions. The intervention will be applied until a total of four local twitch responses will be elicited
15907438|NCT03592095|Device|Placebo needle|Sham dry needling with be conducted with a sham needle (Steitberger's Park sham device (PSD). This needle has a blunt tip and retractable handle that created the illusion of a needle penetrating the skin. When this needle touches the skin, a pricking sensation will be created. However, when pressure will be increased, the shaft of the needle disappears into the handle creating a sensation on the patient.
15907439|NCT03592082|Drug|Bismuth Subsalicylate|BSS 524 mg ((2) 262 mg tablets) given four times per day for 14 days
15907440|NCT03592082|Drug|standard antibiotic therapy|antibiotic therapy administered per standard protocol
15907441|NCT03592069|Drug|10 day concomitant regimen|10 Day Concomitant Hp therapy Concomitant for 10 days, including 40 mg of esomeprazole bid, amoxicillin 1g bid, clarithromycin 500mg bid and metronidazole 500mg bid
15907442|NCT03592069|Drug|14 day hybrid regimen|14 Day Hybrid Hp therapy Hybrid for 14 days, including 40 mg of esomeprazole bid and amoxicillin 1g bid, for the first 7 days followed by esomeprazole 40mg bid, amoxicillin 1g bid, clarithromycin 500mg bid and metronidazole 500mg bid, for another 7 days.
15907443|NCT03592043|Device|MitraClip|Transcatheter Mitral Valve Repair with MitraClip
15907444|NCT03592017|Device|Long-wavelength autofluorescence imaging|Long-wavelength autofluorescence imaging will be performed with a prototype confocal scanning laser (cSLO) ophthalmoscope which will be equipped with additional laser sources and a reference for quantification of the signal. The experimental long-wavelength laser sources will be integrated into a custom-modified Spectralis HRA cSLO from Heidelberg Engineering. The additional laser sources will operate with long wavelength which are less energetic compared to the conventional short-wavelength lasers used currently for routine autofluorescence imaging. All safety standards have been considered and the light exposure for all imaging modes is well below the exposure limits for Class 1 and Class1M laser products as defined in the standard IEC 60825-1, edition 3.0, 2014-5.
15907445|NCT03592004|Other|neoadjuvant chemotherapy|neoadjuvant chemotherapy
15907446|NCT03591991|Drug|Empagliflozin|After randomization,the treatment started 30 minutes before PCI with a dose of 10 mg empagliflozin . After admission, patients were treated with 10 mg empagliflozin once daily for 3 mouths.
15907447|NCT03591991|Other|placebo|After randomization,the treatment started 30 minutes before PCI with a dose of 10 mg placebo . After admission, patients were treated with 10 mg placebo once daily for 3 mouths.
15907448|NCT03591978|Diagnostic Test|Isolation of Circulating Pulmonary Cells in peripheral blood|Blood samples from healthy volunteers will be collected in EDTA tubes (Vacutainer, BD Bioscience). CPC will be isolated according to previous patented method (P201730724)
15907449|NCT03591965|Drug|ATG-008|Approximately 20 subjects will receive oral ATG-008 at an initial dose of 45 mg/QD and another 20 subjects will receive oral ATG-008 at an initial dose of 20mg/BID for 28 days each cycle.
15907450|NCT03591952|Procedure|Suction-Driven Thoracentesis|Thoracentesis is a procedure in which a needle is inserted into the pleural space between the lungs and the chest wall. This procedure is done to remove excess fluid, known as a pleural effusion, from the pleural space to help one breathe easier.
15907451|NCT03591952|Procedure|Gravity-Driven Thoracentesis|Thoracentesis is a procedure in which a needle is inserted into the pleural space between the lungs and the chest wall. This procedure is done to remove excess fluid, known as a pleural effusion, from the pleural space to help one breathe easier.
15907452|NCT03591939|Diagnostic Test|laboratory test|role of T- regulatory cells in the patients of diabetic nephropathy
15907453|NCT03591926|Drug|SM04646|"Nebulized, inhaled solution; single dose concentration dosed once per day for 12 weeks; dosing pattern will follow a 2 weeks on, 2 weeks off regimen, wherein subjects will dose 5 consecutive days of each 7 day on week."
15907454|NCT03591913|Drug|Misoprostol|Oral tablets
15907455|NCT03591900|Device|insulin pump/CGMS|"A-Continuous glucose monitoring system (CGMS) : A glucometer will be given to each patient and will be asked to measure blood glucose before meals and snacks and record the valus in the CGMS for better calibration (Khammar A et al., 2009).
~B-Therapeutic intervention:
~Thalassemia patients who proved to have diabetes according to the ADA criteria will be subjected to
~• Insulin pump will be tried in each diabetic thalassemic patient versus conventional insulin therapy(Bruttomesso D et al., 2009)."
15907456|NCT03591887|Biological|ABY-035|ABY-035 solution for injection
15907457|NCT03591887|Biological|Placebo|Placebo to ABY-035 solution for injection
15907458|NCT03591874|Drug|Brimonidine Tartrate|Brimonidine Tartrate Nanoemulsion Eye Drops given 2 times a day for 12 weeks.
15936773|NCT03367143|Drug|Etoposide|
15907459|NCT03591874|Drug|Placebos|Opthalmic buffered saline solution Eye Drops given 2 times a day for 12 weeks.
15907460|NCT03591861|Procedure|Ketogenic diet|"Children under 2 years will immediately start on a full calorie classical 3:1 ketogenic diet. The 3:1 ratio indicates that the diet contains 3 g of fat for every 1 g of protein + carbohydrate, which results in about 87% of calories coming from fat.
~Children 2 years or older will skip breakfast and lunch on the day of admission but start a full calorie 3:1 ketogenic diet at dinner."
15907461|NCT03591861|Drug|BCNU|-Standard of care
15907462|NCT03591848|Behavioral|Online support decision tool|Online support decision tool, in addition of the standard oral information
15907463|NCT03591848|Behavioral|standard oral information|standard oral information
15907464|NCT03591835|Other|Weight+6|For the Tochen formula in Group 1, ETT depth will be calculated by taking the infant's actual weight within the last 24 h and adding 6 cm.
15907465|NCT03591835|Other|NTL+1|The infants in Group 2 will be intubated by measuring the NTL, the distance from the basement of the nasal septum to the the tragus of the ear. Measurements will be recorded as centimeters.
15907466|NCT03591822|Behavioral|A : Systemic evaluation of the pain and mediation with the PARO therapeutic robot|Each session with the PARO robot will encompasses the same four following steps (a) Meeting Paro (b) Proposing contact (c) Individually using Paro during the care (d) End of the exposure.
15907467|NCT03591822|Behavioral|B : Systemic evaluation of the pain|A systematic evaluation of the pain
15907468|NCT03591809|Other|combined exercise training|The combined exercise training group will be given combined exercise training, consisting of Pilates and aerobic exercise, three times during 8 weeks.
15907469|NCT03591796|Device|HFOV|Ventilated infants were randomized to HFOV
15907470|NCT03591796|Device|CMV|Ventilated infants were randomized to CMV.
15907471|NCT03591770|Biological|SHINGRIX|"SHINGRIX is a vaccine indicated for prevention of herpes zoster (shingles) in adults aged 50 years and older.
~SHINGRIX is a suspension for injection supplied as a single-dose vial of lyophilized gE antigen component to be reconstituted with the accompanying vial of AS01B adjuvant suspension component. A single dose after reconstitution is 0.5 mL.
~Dose and Schedule: Two doses (0.5 mL each) administered intramuscularly according to the following schedule: A first dose at Month 0 followed by a second dose administered anytime between 2 and 6 months later."
15907472|NCT03591757|Drug|Tolcapone|Tolcapone will be administered at 300 mg/day (100mg TID) orally to participants for 14 days and then 600 mg/day (200 mg TID) orally to participants for 14 days (approximately 5 hours apart). Participants will initiate 200mg TID after blood collection on Day 14.
15907473|NCT03591744|Drug|Bortezomib|Given SC
15907474|NCT03591744|Biological|Daratumumab|Given IV
15907475|NCT03591744|Drug|Dexamethasone|Given IV and PO
15907476|NCT03591744|Drug|Lenalidomide|Given PO
15907477|NCT03591744|Drug|Pegylated Liposomal Doxorubicin Hydrochloride|Given IV
15907478|NCT03591731|Drug|Nivolumab|Nivolumab 3 mg/kg every 2 weeks
15907479|NCT03591731|Drug|Ipilimumab|Ipilimumab 1 mg/kg every 6 weeks
15907480|NCT03591718|Drug|BI 456906|Solution for injection
15907481|NCT03591718|Drug|Placebo|solution for injection
15907482|NCT03591705|Drug|TACE-HAIC|transcatheter arterial chemo-lipiodolization with EADM 30mg/m2, followed by hepatic artery infusion Oxa 85 mg/m2, CF 400 mg/m2, 5-Fu 400 mg/m2, 5-Fu 1200mg/m2 infusion 23h.
15907483|NCT03591705|Drug|HAIC|hepatic artery infusion Oxa 85 mg/m2, CF 400 mg/m2, 5-Fu 400 mg/m2, 5-Fu 1200mg/m2 infusion 23h.
15907484|NCT03591692|Procedure|ACAF surgery|The main surgical procedures include discectomy of the involved levels, thinning of the anterior part of the involved vertebrae, intervertebral cages, anterior plate and screws installation, bilateral osteotomies of the vertebrae, and antedisplacement of the vertebrae-OPLL complex
15907485|NCT03591692|Procedure|ACCF surgery|Removal of the vertebral body，exposed ossification of the posterior longitudinal ligament，and then removed
15907486|NCT03591679|Drug|Oxytocin|20 units by slow intravenous drip injection
15907487|NCT03591679|Procedure|bilateral uterine artery ligation|• The peritoneum over the vesico-uterine pouch already being incised horizontally, the peritoneum over the uterine isthmus and cervix was dissected downwards, and this dissection was then extended laterally.
15907488|NCT03591666|Drug|Anlotinib|Anlotinib p.o. qd
15907489|NCT03591653|Drug|LXI-15028|The investigational products are administrated orally, once in the morning every day, and each dose includes one tablet of investigational products (LXI-15028 50mg active agent or placebo). If the investigational product is not taken in the morning, subjects can take it before 6:00 p.m. on the same day. The duration of treatment is 4 weeks.
15907490|NCT03591653|Drug|Placebo|Placebo
15907491|NCT03591640|Diagnostic Test|Blood test|Standard blood test
15907492|NCT03591627|Diagnostic Test|Transesophageal echocardiography|Transesophageal echocardiography will be used to exclude the presence of an LA thrombus before AF/AFI ablation or cardioversion.
15907493|NCT03591614|Biological|DKK1|The investigational agent is a DKK1 peptide-loaded autologous dendritic cell vaccine dispensed at a dose of 5-10x106 in 0.5 mL Plasma-Lyte A + 5% HSA.
15907494|NCT03591601|Other|Manual Therapy protocol|Treatment based on manual therapy with proven evidence.
15907495|NCT03591601|Other|Foam Rolling protocol|Treatment based on massage with a Foam Rolling
15907496|NCT03591601|Other|Placebo control|Placebo treatment based on the placement of the hands on the head without intention to treat.
15907497|NCT03591588|Other|diet|The study includes 2 types of diets, i.e., high-saturated fat diet and low-fat high-protein diet, which are provided to each participant in a randomized crossover design.
15907498|NCT03591575|Drug|Deferiprone oral solution|Liquid formulation of deferiprone, with a concentration of 80 mg/mL
15907499|NCT03591575|Drug|Placebo|Liquid solution that matches deferiprone oral solution in appearance and taste
15907500|NCT03591549|Drug|Faslodex|intramuscular injection monthly
15907501|NCT03591549|Drug|Zoladex|intramuscular injection monthly
15907502|NCT03591536|Other|Pentoxifylline|400 mg pentoxifylline oral tablet from 3 days before surgery and on the day of surgery
15907503|NCT03591536|Other|Placebo|oral placebo tablets from 3 days before surgery and on the day of surgery
15907530|NCT03591419|Device|polymer clip|polymer clips will be used to ligate the stump of appendix during appendectomy and time for application and cost of clips will be calculated
15907504|NCT03591523|Diagnostic Test|Quantitative MR angiography|Quantitative MR angiography: A standard axial 3-dimensional time-of-flight (TOF) MRA of intracranial and cervical arteries will be obtained. Then, the acquired images will be transmitted to the workstation to reconstruct 3D surface-rendered vessel images. After determining optimal perpendicular scan plane and setting the baseline coordinates , retrospectively gated, fast 2-dimensional phase-contrast sequence will be performed. Velocity encoding will be automatically adjusted by NOVA software.
15907505|NCT03591523|Diagnostic Test|Duplex sonography|Duplex sonography of cervical arteries will be performed using 5 - 12 MHz linear duplex probe and transcranial color-coded duplex sonography will be performed using 2 - 5 MHz transcranial duplex probe. Peak systolic velocity, end diastolic celocity, mean blood flow velocity and arterial diameter will be measured with automatic calculation of blood flow velocity in each arterial segment.
15907506|NCT03591510|Drug|Midostaurin|midostaurin 30mg/m2 bid
15907507|NCT03591510|Drug|Fludarabine|30mg/m2/day on D1-D5 of Block 2 FLADx
15907508|NCT03591510|Drug|Cytarabine|"Part 1:
~2000mg/m2/day D1 to D5 of Block 2 FLADx 1000mg/m2 every 12 hours D1 to D3 Block 3 HAM 3000mg/m2 every 12 hours D1 to D3 Block 4 HA3E 3000mg/m2 every 12 hours D1 to D3 Block 5 HIDAC
~Part 2:
~1000mg/m2 every 12 hours D1 to D3 Block 2 HAM 3000mg/m2 every 12 hours D1 to D3 Block 3 HA3E 1000mg/m2 every 12 hours D1 to D3 Block 4 HAM 3000mg/m2 every 12 hours D1 to D3 Block 5 HIDAC"
15907509|NCT03591510|Drug|Daunorubicin or idarubicin|daunorubicin 60 mg/m2/day OR idarubicin 12mg/m2/day On D2, D4, D6 of Block 2 FLADx
15907510|NCT03591510|Drug|Mitoxantrone|10mg/m2/day D3 and D4
15907511|NCT03591510|Drug|Etoposide|100mg/m2/day D1 to D5
15907512|NCT03591497|Other|Virtual Reality|As described in Experimental arm description.
15907513|NCT03591484|Radiation|Photodynamic therapy|Treatment with Photodynamic therapy. The evaluation of halitosis and the microbiological analysis will be repeated before this step
15907514|NCT03591484|Device|Treatment with tongue scraper|Treatment with tongue scraper. The evaluation of halitosis and the microbiological analysis will be repeated before this step
15907515|NCT03591484|Procedure|Periodontal treatment|Periodontal treatment will be performed with curettes and ultrassom. The evaluation of halitosis and the microbiological analysis will be repeated before this step
15907516|NCT03591484|Procedure|hygiene procedures for the mucosa and dentures|edentulous participants will be submitted to hygiene procedures for the mucosa and dentures. The evaluation of halitosis and the microbiological analysis will be repeated before this step
15907517|NCT03591471|Drug|Glycosides Of Tripterygium Wilfordii Hook(GTW)|"For severe HSPN GTW is 2mg/kg/d for the first 2 weeks , continued with 1.5mg/kg/d (maximum to 90mg/d) for another 2 weeks; For light HSPN GTW is 1.5mg/kg/d(maximum to 90mg/d) for 4 weeks.
~Both the 2 types are continued with 1mg/kg/d of GTW for another 4 weeks . Besides,Sulfotanshinone Sodium Injection,Qingrezhixue graunles,Chinese herbs by syndrome differentiation are plused at the same time"
15907518|NCT03591471|Drug|Sulfotanshinone Sodium Injection|Intravenous drip of Sulfotanshinone Sodium Injection with the dosage of 1mg/kg/d(maximum to 50mg), combined with 100-250ml 5% Glucose Solution (G.S) for 2 weeks in both the light and serious type of TCM group.
15907519|NCT03591471|Drug|Chinese herbs based on syndrome differentiation|"For both the light and serious type of HSPN in TCM group,five traditional Chinese medicine patterns of syndrome are classified on the main pathogenesis Blood Stasis: based on Qingre Zhixue granule,for wind-heat complicated with blood stasis, add Forsythia, Honeysuckle,;for blood-heat complicated with blood stasis,add Buffalo horn,Comfrey; for yin deficiency complicated with blood stasis, add Rhizoma anemarrhenae,Cortex phellodendri;for both qi and yin deficiency complicated with blood stasis,add Astragalus, Heterophylla;for damp-heat complicated with blood stasis,add Scutellaria baicalensis,Lalang Grass Rhizome."
15907520|NCT03591471|Drug|Prednisone Acetate Tablets|Prednisone Acetate Tablets are necessary for serious HSPN in controlled group,the initial dosage is 2mg/kg/d(maximum to 30mg,4 weeks),continue to reduce the dosage until discontinued（Reduce the dosage at the rate of 5mg every other day in 4-8 weeks，then reduce the dosage at the rate of 5-10mg per week in 8-12weeks）
15907521|NCT03591471|Drug|Benazepril Hydrochloride Tablets|In controlled group, Benazepril Hydrochloride Tablets are used for both the light and serious type with the dosage of 5-10mg/d(10mg/d for children with weight above 30kg) ,12 weeks in total.
15907522|NCT03591471|Drug|Low Molecular Weight Heparin Calcium Injection|In controlled group,Low Molecular Weight Heparin Calcium Injection are used for both the light and serious type with the dosage of 100u/kg/d by hypodermic injection for 2 weeks
15907523|NCT03591471|Drug|Dipyridamole Tab 25 MG|In controlled group,Dipyridamole Tab 25 MG are used for both the light and serious type of HSPN with the dosage of 3mg/kg/d ,3 times a day,12 weeks in total.
15907524|NCT03591471|Drug|Chinese medicine placebo|In controlled group,take a potential necessary for patients who come to the hospital of TCM to take traditional Chinese medicine in consideration, we add the traditional Chinese medicine placebo in controlled group.
15907525|NCT03591458|Drug|Amitriptyline|Participants will receive a supply of Amitriptyline capsules for titration, intervention, and taper periods.
15907526|NCT03591458|Drug|Placebo|Participants will receive a supply of Placebo capsules, matching those of Amitriptyline, for the titration, intervention, and taper periods
15907527|NCT03591445|Device|Flexible Bronchoscopy|Flexible Bronchoscopy
15907528|NCT03591432|Device|Transnasal humidified rapid insufflation ventilatory exchange (THRIVE)|Transnasal humidified rapid insufflation ventilatory exchange (THRIVE) is a new technique that is available for use in critically ill patients and in patients with difficult airways. The technique combines the benefits of apneic oxygenation and CPAP with a reduction in CO2 levels through gaseous mixing and flushing of the dead space. THRIVE is administered through a standard, commercially available, nasal, high-flow oxygen delivery system. Insufflation of O2 up to 70 L/min via a purpose-made nasal cannula is used initially to provide preoxygenation, which can be continued during intravenous induction until a definitive airway is secured. The THRIVE technique has been demonstrated to appreciably prolong the safe duration of apnea while avoiding increase in CO2.
15907529|NCT03591432|Device|Facemask ventilation|Nowadays pre-oxygenation is usually achieved using oxygen delivered via a facemask before induction of anaesthesia; this potentially extends the time available for securing the airway before hypoxaemia to 6 min. In patients undergoing elective surgery, the lungs are normally ventilated with a bag/facemask technique after induction, and this can be repeated if attempts at intubating the trachea are prolonged.
15907561|NCT03591172|Drug|Nano-propolis|Using Nano-propolis as a final irrigation in revasculariztion
15907531|NCT03591419|Device|endoloop|endoloop will be used to ligate the stump of appendix during appendectomy and time for application and cost of clips will be calculated
15907532|NCT03591406|Drug|Ferric carboxymaltose|Dosage Form: Injection, Sterile FCM solution as a 5% w/v iron solution in water for injection Strength: 10 mL vials containing 500 mg iron per vial Dosage: 500mg/week or 1000mg/week (based on subject BW and Hb value at screening) Route of administration: IV injection (undiluted solution) or drip infusion (500 mg iron diluted in 100 mL 0.9% w/v physiological saline or 1,000 mg iron diluted in 250 mL 0.9% w/v physiological saline) Dosing schedules: baseline (Day 1) and, if required, at Day 8 and Day 15.
15907533|NCT03591406|Drug|Iron sucrose|Dosage Form: Sterile solution for injection containing 2% w/v iron Strength: 5 mL ampoules containing 100 mg iron per ampoule Dosage: single doses of IS of 200mg iron based on the formula of Ganzoni: Cumulative iron deficit [mg] = BW [kg] x (target Hb- actual Hb) [g/dL] x 2.4 + 500 mg, up to 11 IS injections will be given Route of administration: IV injection or drip infusion Dosing schedules: three times a week, with an initial dose at baseline and will receive iron, as per approved label, until the subject has received the calculated iron dose.
15907534|NCT03591393|Diagnostic Test|questionnaire|"Validated self-administered questionnaires with five domains: Wexner questionnaire for anal incontinence, PAC-SYM for constipation, International Consultation on Incontinence Questionnaire Short Form for urinary incontinence, the Pelvic Organ Prolapse Distress Inventory for pelvic organ prolapse, POP/UI Sexual Questionnaire - IUGA revised for sexual function.
~The body image perception will be assessed using the Dutch-validated version of the self-administered Body Image Disturbance Questionnaire."
15907535|NCT03591380|Drug|Belimumab|Kidney transplant recipients (n=5) will receive standard of care (SOC) therapy consisting of alemtuzumab and steroid induction with mycophenolic acid and tacrolimus maintenance immunosuppression, plus induction and treatment for 6 months with belimumab.
15907536|NCT03591367|Diagnostic Test|MicroRNAs-155|Quantitative analysis of cell-free miR-155 using RT-qPCR.
15907537|NCT03591367|Diagnostic Test|Human telomerase reverse transcriptase|Analysis TERT by TERT messenger RNA (mRNA)expression by reverse transcription-quantitative polymerase chain reaction.
15907538|NCT03591354|Device|t:slim X2 with Control-IQ Technology & Dexcom G6 CGM|Participants will use the Tandem t:slim X2 insulin pump with Control-IQ Technology & Dexcom G6 CGM for 3 months.
15907539|NCT03591354|Device|t:slim X2 with Basal-IQ & Dexcom G6 CGM|Participants will use a Tandem t:slim X2 insulin pump with Basal-IQ and a study CGM (Dexcom G6) for 3 months.
15907540|NCT03591341|Diagnostic Test|melatonin level in pumped breast milk|diagnostic test of melatonin level in pumped breast milk
15907541|NCT03591328|Diagnostic Test|Coronary CT angiography|"CCTA images will be screened for APC and CFD analyses. The presence of APC (low-attenuation plaque, positive remodeling, napkin-ring sign, and spotty calcification) will be assessed in each lesion by an independent observer blinded to the clinical data and CFD results according to the definitions from previous studies.
~In order to evaluate incremental value of hemodynamic parameters, CFD will be performed in the independent core laboratory (HeartFlow Inc.). In consideration of potential clinical implications proposed in previous studies, 4 hemodynamic parameters will be computed for covariates in prediction models: 1) per-vessel FFR derived from cCTA (FFRCT); 2) change in FFRCT across the lesion (△FFRCT); 3) wall shear stress (WSS); and 4) axial plaque stress."
15907542|NCT03591315|Diagnostic Test|resting state fMRI|Define the visual resting state network.
15907543|NCT03591315|Diagnostic Test|visual tasking state fMRI|Using visual task stimulation to identify the activation characteristic of primary visual cortex.
15907544|NCT03591315|Diagnostic Test|diffusion tensor imaging|Define the integrity of white matter fibers in the visual pathway.
15907545|NCT03591315|Diagnostic Test|automated visual field|Identify the existence and type of visual field defect.
15907546|NCT03591315|Diagnostic Test|visual acuity|Assess the visual acuity by using ETDRS scales.
15907547|NCT03591302|Biological|Hematopoietic cell transplantation|Transplantation of hematopoietic stem cells from living donor.
15907548|NCT03591302|Radiation|Total Lymphoid irradiation|Total lymphoid irradiation is used as part of the conditioning regimen for the hematopoietic stem cell transplant.
15907549|NCT03591289|Drug|NMB with rocuronium bromide|Moderate versus deep neuromuscular block Not a device study
15907550|NCT03591276|Drug|Chemotherapy Drugs, Cancer|IV pembrolizumab 200 mg flat dose with IV PLD 30 mg/m2 (chemotherapy drugs) every 3 weeks in eligible breast cancer patients.
15907551|NCT03591263|Other|Pulmonary rehabilitation|Pulmonary rehabilitation as routine care includes, airway clearance techniques, breathing exercise, and physical training instruction
15907552|NCT03591237|Behavioral|Mindfulness-Based Cognitive Therapy|The patients participate in eight weekly group sessions of two hours each and will be asked to do an additional 45 minutes of daily training at home. The participants will be asked to record their home training to allow assessment of their adherence to the intervention. Generally, the program corresponds to the manualized MBCT program, but with adaptations that take into account the special needs of cancer patients, including shorter sessions, shorter yoga exercises and the omission of the all-day session. The sessions include psychoeducation and formalized mindfulness exercises with focus on the participants' here-and-now experience of their pain.
15907553|NCT03591224|Other|Pharmacogenomic Testing|pharmacogenomic drug response test provides personalized insights on a patient's predicted response to medications based on metabolism
15907554|NCT03591224|Other|Pharmacist Standard of Care|Pharmacist providing standard of care as per usual practice
15907555|NCT03591211|Behavioral|Qigong Training|Eight-Section Brocades; participants were trained individually.
15907556|NCT03591211|Behavioral|Cognitive Training|Cognitive Training of Memory and Executive Function with Activities requiring Mobilization
15907557|NCT03591198|Behavioral|Qigong Training|Eight-Section Brocades
15907558|NCT03591198|Behavioral|Cognitive Training|Cognitive Training of Memory and Executive Function with Activities requiring Mobilization
15907559|NCT03591185|Other|FallSensing Clinical Tool|"FallSensing clinical tool will be applied to a group of community-dwelling adults aged 50 years or over, including a initial evaluation, 24 intervention sessions (2 or 3 sessions per week) and a final evaluation.
~Inicial and final evaluation consists in six functional tests (Grip Strength, Timed Up and Go, 30 seconds Sit-to-Stand, Step test, 4 Stage Balance test modified and 10 meters Walking Speed) and a questionnaire concerning self-efficacy for exercise."
15907560|NCT03591172|Drug|Propolis|Using propolis as a final irrigation in revascularization
15907564|NCT03591146|Drug|TLC590|TLC590 lyophilized cake will be reconstituted with the TLC590 reconstitution solution to form the TLC590 ropivacaine liposome injectable suspension
15907565|NCT03591146|Drug|Naropin|Local infiltration of Naropin to produce anesthesia for surgery and analgesia in postoperative pain management. Naropin 150mg [0.5%, 5mg/mL] x 30mL
15907566|NCT03591133|Drug|TS-143|
15907567|NCT03591133|Drug|Placebo|
15907568|NCT03591107|Other|PTSD Care Management (PCM)|Collaborative care for PTSD facilitated by a trained CM who will engage the patient into care, monitor progress over 6 months, coordinate care with primary care and behavioral healthcare providers and social services, and receive monthly supervision by the study psychiatrist in addition to education and feedback
15907569|NCT03591107|Other|Minimally Enhanced Usual Care (MEU)|Education and feedback alone
15907570|NCT03591094|Drug|PTI-428|Active
15907571|NCT03591094|Drug|Placebo|Placebo
15907572|NCT03591081|Other|Intellin smart phone application|This feasibility study will explore if creating an electronic platform Intellin smart phone application can promote and support timely self-referral for individuals with a recently healed DFU. It will explore the software applications acceptance and ease of use for patients.
15907573|NCT03591068|Drug|Fluticasone Propionate|OPN-375 186 μg BID, Delivered via exhalation delivery system
15907574|NCT03591055|Other|CGA, medication review, exercise and cognitive stimulation|Comprehensive geriatric assessment. Patient-centered interventions according to the different target areas identified in the geriatric assessment. Medication review. Groupal Exercise plan and memory workshops.
15907575|NCT03591042|Diagnostic Test|cervical length screening|transvaginal ultrasound cervical length
15907576|NCT03591029|Other|blood samples|blood samples will be obtained from the superior vena cava (via centra venous catheter), from the pulmonary artery (via Swan Ganz catheter), and from a radial or femoral artery catheter
15907577|NCT03591016|Other|Recording number of IV attempts|Recording number of IV attempts in the operating room
15907578|NCT03591003|Diagnostic Test|Yellow fever neutralizing antibodies measure|Yellow fever neutralizing antibodies measure before vaccination, within the year after vaccination and at any delay after vaccination
15907579|NCT03590990|Diagnostic Test|Ultrasonsography, mammography, biopsy|Ultrasonsography of lump in breast Mammography of patents above 35 years Biopsy if indicated
15907580|NCT03590977|Other|licorice extract mouthwash|mouth rinse that contains a natural herbal licorice root extract used as a preventive measure that reduce caries index.
15907581|NCT03590977|Other|chlorohexidine mouthwash|mouth wash that contains chlorohexidine as an active component
15907582|NCT03590964|Procedure|Open sinus lift using chin bone graft|Patients with atrophied posterior maxilla will undergo open sinus lift with chin bone graft according to standardized surgical approach.
15907583|NCT03590964|Procedure|Sinus lift using bone ring containing the implant.|Patients with atrophied posterior maxilla will undergo sinus lift with chin bone ring containing the implant.
15907584|NCT03590951|Other|Retrospective chart review|A retrospective chart review was conducted to evaluate the effect of body mass index on obstetric, anesthetic and neonatal complications in patients who underwent cesarean section at our institution
15907585|NCT03590912|Drug|Mometasone 50 Mcg/Inh Nasal Spray|One spray in each nostril once daily for one month
15907586|NCT03590912|Drug|Antibiotics + Antihistamine (levocetirizine) + Nasal decongestants (Oxymetazoline 0.025%)|Children in this group will be treated with antiboitics (syp cefpodoxime) at 10 mg/kg/day in two divided dose for a week, plus antihistamine and nasal decongestants. Oral levocetirizine (Syrup levocet 2.5 mg/5ml) 1.25 mg once daily for age up to six years, 2.5 mg once daily for elder children for a month, plus oxymetazoline (Nasivion) 0.025%, 4 drops twice daily for two weeks
15907587|NCT03590912|Drug|Steroid Drug (prednisolone)|This group will be treated with steroid drugs. Oral prednisolone, 1 mg/kg body weight daily in two divided dose for 1 week followed by half mg/kg/day in two divided dose for next one week.
15907588|NCT03590899|Device|Optical coherence tomography angiography (Zeiss Cirrus HD OCT 5000 AngioPlex)|Non-invasive, non-contact optical coherence tomography angiography scans of the retina are done per built-in device protocol using the Zeiss Cirrus HD OCT 5000 AngioPlex machine.
15907589|NCT03590886|Other|total response Group|biochemical response for UDCA treatment more than 1 year according to Paris-I/II standard
15907590|NCT03590873|Drug|Vasopressin|Vasopressin, is a hormone synthesized as a peptide prohormone in neurons in the hypothalamus, and is converted to arginine vasopressin. It then travels down the axon of that cell, which terminates in the posterior pituitary, and is released from vesicles into the circulation in response to extracellular fluid hypertonicity (hyperosmolality). Arginine vasopressin has two primary functions. First, it increases the amount of solute-free water reabsorbed back into the circulation from the filtrate in the kidney tubules of the nephrons. Second, arginine vasopressin constricts arterioles, which increases peripheral vascular resistance and raises arterial blood pressure.
15907591|NCT03590860|Drug|LY3322207|Administered by SC injection
15907592|NCT03590860|Drug|Placebo|Administered by SC injection
15907593|NCT03590847|Behavioral|Intermittent Fasting|Study participants will be asked to fast for a target of 16 hours per day for a period of 4 weeks. Participants will be allowed to consume calorie-free beverages, water, tea, black coffee or sugar-free gum during the fasting period. Participants will be asked to record the time of first and final food/drink consumption each day.
15907594|NCT03590834|Behavioral|Center-based Intervention|"Center nutrition and physical activity policy modification to increase fruit and vegetable servings and more physical activity throughout the day
~Staff training and technical assistance
~Health education on healthy habits (diet, physical activity, sleep, screen time) using the Sesame Workshop Healthy Habits for Life (HHL) resource kit
~Health contests
~Gross motor and physical activity program
~Miranos! activity cards based on children storybooks"
15907595|NCT03590834|Behavioral|Home-based Intervention|"Monthly interactive poster education sessions led by parent peer educators during child pick-up time. Held at Head Start Center. These sessions include family health challenges and take-home activities.
~Three Home Visits delivered by Head Start staff. Obesity prevention goal-setting integrated into existing Head Start home visits
~16 semi-monthly, Family Newsletters with stories, tips, and strategies to promote healthy habits for preschool children
~Incorporating activities related to PA, nutrition and sleep into existing Head Start Center Summer Calendars"
15937147|NCT03364309|Drug|Ixekizumab|Administered SC
15907596|NCT03590834|Behavioral|Active Control|"Children will receive Head-Start-approved health education program for children: I Am Moving, I Am Learning. In addition, the investigators will deliver an early childhood literacy program to all active control children to increase buy-in and retention."
15907597|NCT03590821|Drug|Aspirin 81 mg|timed administration of aspirin in the evening
15907598|NCT03590821|Drug|Celecoxib 200mg capsule|daily administration of celecoxib
15907599|NCT03590808|Biological|Influenza vaccination|Purified inactivated influenza virus antigen (Green Cross Corp) 0.5 mL once IM
15907600|NCT03590795|Other|Sleep survey|The Sleep survey was created by the Collaborative Research Center (CRC), a joint effort of the Australian Government, Academia and Industry [including Philips]).
15907601|NCT03590782|Other|Erector Spinae Block|An ultrasound guided erector spinae block will be performed.
15907602|NCT03590769|Drug|18F-FDG|All subject will undergo PET/MRI scans pre-operatively, 1 day and 1 week post-operatively using FDG
15907603|NCT03590756|Other|16 weeks mango intake|Participants will be provided fresh frozen Ataulfo mangoes.
15907604|NCT03590743|Drug|Apixaban|Active anticoagulation with apixaban 10 mg twice daily for 7 days followed by 5 mg twice daily to complete a total of 3 months treatment.
15907605|NCT03590743|Other|Placebo|apixaban matching placebo 2 tablets twice daily for 7 days followed by one tablet twice daily to complete a total of 3 months.
15907606|NCT03590730|Device|ICD implantation|ICD will be implanted according to current guidelines recommendations.
15907607|NCT03590717|Behavioral|BCC-Only|Households in the 'BCC-only' arm receive SBCC but do not receive vouchers.
15907608|NCT03590717|Other|Small-voucher|Households in the 'Small-voucher' arm receive a voucher (~$12-17) every month that entitles them to purchase fresh foods (fruits, vegetables and animal sourced foods). The households in this arm also receive the same social behavioural change communication (SBCC) messages as the 'BCC-only' arm.
15907609|NCT03590717|Other|Large-voucher|Households in the 'Large-voucher' arm receive a larger voucher (~$21-23) every month that entitles them to purchase fresh foods (fruits, vegetables and animal sourced foods). The households in this arm also receive the same social behavioural change communication (SBCC) messages as the 'BCC-only' arm.
15907610|NCT03590704|Device|Vitaltape® bandage|The neuromuscular bandage will be applied after skin antisepsis with 70% alcohol. A 5 cm width Vitaltape® neuromuscular bandage will be used. For the bandage application, a distal base (anchor) with two centimeters of diameter will be maintained with maximum stretching on the seroma and finalized with another base no stretching, of 2 cm, in the proximal region. How many bundles of bandages are required according to the patient's body characteristics and aspect of the flotation region.
15907611|NCT03590691|Other|Vietnam National Hypertension Program|A training program for health care workers including physicians and nurses and a health educational program for general public regarding hypertension management at community level will be implemented
15907612|NCT03590691|Other|Expanded community health worker services|A training program will be implemented for community health workers regarding hypertension management at community level so that they can assist patients better manage their blood pressure at home.
15907613|NCT03590691|Behavioral|Storytelling intervention|The storytelling intervention consists of interactive, literacy-appropriate, and culturally sensitive multimedia storytelling modules for motivating behavior change through the power of patients speaking in their own voice. Based on preferences that emerged during the researchers' formative work with the partnering rural communities, the storytelling intervention will be delivered by DVD, with serial installments at baseline and at 3, 6, and 12 months after trial enrollment.
15907614|NCT03590691|Behavioral|Home blood pressure self-monitoring|Patients with hypertension will be provided blood pressure monitors and guided to self-measure their blood pressure and to record their blood pressure daily at home.
15907615|NCT03590665|Other|Hand grip exercise and lower body negative pressure|For participants with Down syndrome, the first visit includes baseline measures and familiarization with the graded maximal exercise test protocol. If necessary, additional familiarization sessions will be scheduled for people with Down syndrome. The second visit, we perform the graded maximal exercise test and familiarize the participant with the procedures for the third visit: the hand grip exercise protocol and the lower body negative pressure (LBNP) box. The third visit we assess the peripheral blood flow during the hand grip exercise protocol without and with the LBNP. For control subjects, the first and second visit are combined. Their second visit is the same as the third visit for individuals with Down syndrome.
15907616|NCT03590652|Drug|Ixazomib|4mg PO days 1,8,15 on 28-day cycle
15907617|NCT03590652|Drug|Pomalidomide|4mg days PO 1-21/28 days
15907618|NCT03590652|Drug|Dexamethasone|"40mg** PO weekly
~** starting dose for age >75 may be 20mg"
15907619|NCT03590652|Drug|Daratumumab|16mg/kg IV weekly x 8 weeks, biweekly x 8 doses, then monthly
15907620|NCT03590626|Drug|Dulaglutide|0.75 mg weekly for 4 weeks followed by 1.5 mg weekly for 20 weeks
15907621|NCT03590613|Drug|GSK2982772|GSK2982772 will be available as white to almost white, round, film coated tablets to be administered via oral route
15907622|NCT03590613|Drug|Placebo|Placebo matching GSK2982772 will be available as white to almost white, round, film coated tablets to be administered via oral route.
15907623|NCT03590600|Drug|BTZ-043|Powder and solvent for oral suspension
15907624|NCT03590600|Drug|Placebo|Matching placebo: powder and solvent for oral suspension
15907625|NCT03590587|Drug|0.19 mg fluocinolone acetonide (FAc) implant|0.19 mg fluocinolone acetonide (FAc) implant
15907626|NCT03590587|Device|0.19 mg fluocinolone acetonide (FAc) implant|0.19 mg fluocinolone acetonide (FAc) implant
15907627|NCT03590574|Biological|AUTO4|AUTO4 (RQR8/aTRBC1 CAR T cells) Following pre-conditioning with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with doses from 25 to 225 x 10^6 RQR8/aTRBC1 CAR T cells. Following Phase 2 dose determination patients will be treated with selected doses of RQR8/aTRBC1 CAR T cells (AUTO4).
15907628|NCT03590561|Other|High caloric diet|After dietary counseling, subjects will receive high caloric snacks for five days.
15907629|NCT03590548|Diagnostic Test|gausher disease|lab investigation and radio logical
15907630|NCT03590535|Diagnostic Test|4th Gen cTnT|"Current Fourth Generation Cardiac Troponin T Enzyme Assay"
15907631|NCT03590535|Diagnostic Test|5th Gen cTnT|"New Fifth Generation (High-sensitivity) Troponin T Enzyme Assay"
15908514|NCT03584074|Drug|Celebrex 200Mg Capsule|Orally taken once daily for 8 weeks
15907632|NCT03590522|Genetic|Ryanodine Receptor 2 gene expression|Ryanodine Receptor 2 gene expression will be measured by real time PCR. In addition, amino acids analysis will be measured in plasma by amino acid analyzer.
15907633|NCT03590509|Other|Telemedicine Program|"A telemedicine platform (Zoom) will be added to comprehensive care (CC) to be used by the CC providers to make observations in the home to augment care, help address acute problems remotely at any hour, better coordinate care with healthcare personnel, and thereby reduce clinic visits, ED visits, and hospitalizations. Home visits* will be conducted by a nurse home visitor whenever considered likely to be beneficial for any of the CMC and at least once by the assigned CC provider immediately following enrollment of children with chronic respiratory failure requiring mechanical ventilation at home.
~*After the approval of the study protocol, the home-visitation component of the integrated intervention was deemed not to be feasible with the available resources and personnel and has was not implemented"
15907634|NCT03590509|Other|Usual Comprehensive Care|Comprehensive care (CC) provided in an enhanced medical home to assure effective care at any hour for or children with medical complexity
15907635|NCT03590496|Dietary Supplement|Calcium-Propionate 500mg|Calcium-Propionate capsules
15907636|NCT03590496|Other|Placebo|Placebo capsules without any active ingredient
15907637|NCT03590470|Other|Implementation of a nurse-led model of care|A nurse-model of care consisting of a specifically trained geriatric nurse expert, communication and quality improvement tools will be implemented in 11 nursing homes in the German speaking part of Switzerland
15907638|NCT03590457|Device|Airvo 2; High-Flow nasal cannula system|Noninvasive device used to deliver humidified oxygen at high flow rates up to 60 liters per minute
15907639|NCT03590444|Drug|Ranibizumab 0.5 MG/0.05 ML Intraocular Solution|"Focal laser treatment will be performed using argon laser photocoagulation (VISULAS 532s®, Carl Zeiss Meditec) operating at 532nm and Ranibizumab 0.5 MG/0.05 ML Intraocular Solution.
~Ranibizumab 0.5 MG/0.05 ML Intraocular Solution"
15907640|NCT03590431|Dietary Supplement|extrinsic iodine in milk|300 ml whole cow's milk delivering ≈ 200 µg iodine (extrinsic iodine, low protein-bound fraction) The whole cow's milk will be produced in an experimental barn feeding supplementary iodine to reach a final iodine concentration of ≈ 50 µg/L. The iodine content of the extrinsically labelled milk will be adjusted to the required concentration (same as intrinsic iodine milk) by adding iodine in form of potassium iodide.
15907641|NCT03590431|Dietary Supplement|intrinsic iodine in milk|300 ml whole cow's milk delivering ≈ 200 µg iodine (intrinsic iodine, high protein-bound fraction) The whole cow's milk will be produced in an experimental barn feeding supplementary iodine to reach a final iodine concentration of ≈ 600 µg/L. This concentration will define final supplemental iodine given to the participants (adapting the total portion size).
15907642|NCT03590431|Dietary Supplement|water iodine solution|300 ml water delivering ≈ 200 µg iodine (control)
15907643|NCT03590405|Procedure|uterus transplantation surgery and IVF|IVF before surgery living donor uterus transplantation ET
15907644|NCT03590392|Biological|ChAdOx1 Chik|ChAdOx1 Chik, a replication-deficient simian adenoviral vector expressing CHIKV antigens.
15907645|NCT03590379|Drug|CHF 5993 DPI|BDP/FF/GB DPI
15907646|NCT03590379|Drug|CHF5993 pMDI|BDP/FF/GB pMDI
15907647|NCT03590379|Drug|CHF 1535 pMDI|BDP/FF pMDI
15907648|NCT03590379|Drug|Placebo DPI|CHF 5993 DPI matched placebo
15907649|NCT03590379|Drug|Placebo pMDI|CHF 5993 pMDI matched Placebo (direct blinding of active CHF 5993 and CHF 1535 pMDIs)
15907650|NCT03590366|Biological|B244|B244 Suspension
15907651|NCT03590366|Biological|Vehicle|Vehicle suspension
15907652|NCT03590353|Device|Dual Chamber Pacemaker|1. Conducting venipuncture. Subclavian vein is our first choice. Then we set up two venous channels and implant two guiding wires into postcava. 2.Putting 2 sheathing canals into heart along with guiding wires. 3.Locating the sheathing canals, and putting electrodes into canals. 3.Adjusting the electrodes and revolving them anticlockwise to lead them to right atrium and right ventricle respectively under the X-ray. 4.Immobilizing electrodes. 5. Some ways to determine whether the electrode is fixed or not: the head of the electrodes could beat rhythmically with atrium or ventricle or by testing damage current. 6.Removing the canals and suturing.
15907653|NCT03590353|Device|His Bundle Pacemaker|1.Conducting venipuncture. Subclavian vein is our first choice. Then we set up two venous channels and implant two guiding wires into postcava. One of the guide wire is 120cm in length, 0.035 or 0.038 in diameter, which is required to lead the C315 sheathing canal. 2.Putting C315 sheathing canal into heart along with guiding wires. 3.Locating the C315 sheathing canal, and adjusting the head of C315 towards ideal pacing location. 3.Implanting the spiral electrodes and fixing them. Leading the spiral electrode to the side of his bundle along the C315 canal under the X-ray. The other electrode is leaded to right atrium like dual chamber pacemaker under the X-ray. 4.Revolving the 3830 electrode suitably to Immobilizing it in cardiac muscle. If the electrode can get his electric potential and produce his bundle pacing successfully, we revolve the 3830 electrode and immobilize it.
15907654|NCT03590340|Biological|PfSPZ Vaccine|Metabolically active, non-replicating, radiation attenuated, aseptic, purified, cryopreserved NF54 P. falciparum (Pf) sporozoites (PfSPZ Vaccine)
15907655|NCT03590340|Other|Normal saline|Normal saline is 0.9% sodium chloride
15907656|NCT03590340|Biological|PfSPZ Challenge (for CHMI)|Live, infectious, aseptic, purified, vialed, cryopreserved, Plasmodium falciparum sporozoites, strain NF54
15907657|NCT03590327|Device|Transcranial Magnetic Stimulation|rTMS
15907658|NCT03590314|Device|Experimental group - robot assisted arm training (Armotion®)|"Passive mobilization and stretching exercises for affected upper limb (10 minutes) followed by robot-assisted exercises (35 minutes). Were selected four types of exercises contained within the Armotion® software:
~Collect the coins
~Drive the car
~Wash the dishes
~Burst the balloons
~For increment the difficulty, we have varied the assisted and non-assisted modality, increasing the number of repetitions over the study period."
15907659|NCT03590314|Other|Control group - conventional treatment|Upper limb passive mobilization and stretching (10 minutes) followed by exercises (35 minutes) that incorporated single or multi-joints movements for the scapula, shoulder and elbow, performed in different positions (i.e. supine and standing position). The increase of difficulty and progression of intensity were obtained by increasing ROM, repetitions and performing movements against gravity or against slight resistance.
15907791|NCT03589222|Drug|Selinexor|Selinexor will be administered via oral at flat dose of 100 mg weekly in 4 out of each 4-week cycle
15907660|NCT03590301|Behavioral|FUNPALs Playgroup|Based on Self-Determination Theory, the FUNPALs Playgroup aims to enable and inspire parents to improve their toddlers dietary intake and physical activity habits through authoritative parenting, structured feeding practices, and a healthy home environment. Playgroups will include open but structured experiential learning activities, free play, and instruction/discussion.
15907661|NCT03590301|Behavioral|Healthy Toddler Parent Group|The parent class will serve as our instruction only control group. Parents in this class will receive information about nutrition and activity recommendations regarding their toddler age children and will discuss it in a group with other parents. No experiential learning activities, information about parenting, or children will be involved in this class.
15907662|NCT03590288|Procedure|Transjugular intrahepatic portosystemic shunt|"Covered stents will be used, that will be dilated to 8 or 10 mm according to the hemodynamic response. The aim will be to reduce the portal pressure gradient (PPG) below to 25-75% of baseline. Not paralleled TIPS or over-dilatation are allowed.
~Embolisation, either with coils or bucrylate, can be performed, if it is felt necessary, especially in patients where portography shows the filling of big portosystemic collaterals feeding the varices.
~After TIPS, anticoagulation will not be used as a rule, but is allowed if the attending physician thinks that it is warranted.
~Measurement of pressure gradient will be repeated within 3 days after the procedure and then at 1 month and 6 months after the procedure.
~A TIPS revision will be performed once shunt dysfunction is suspected."
15907663|NCT03590275|Drug|FOLFIRINOX|Patients treated with first-line FOLFIRINOX (oxaliplatin + irinotecan + lederfolin + 5-fluorouracil) as per clinical practice were included in the study
15907664|NCT03590262|Drug|Metformin|take the metformin 500mg twice or three times a day
15907665|NCT03590249|Procedure|Osteopathic Manipulative Treatment|Osteopathic manipulation involves a number of different manual (hands-on) techniques. These include muscle inhibition (applying pressure to a muscle to induce relaxation); myofascial release (applying pressure to the fascia and moving it toward/away from a strain); muscle energy stretch (contraction of a stretching muscle); counterstrain (shortening a strained muscle); facilitated positional release (moving a vertebra into a restriction and applying a gentle compression); osteopathy in the cranial field (balancing the cranial tissue); balanced ligamentous tension/ligamentous articular strain (moving a joint into ease to release tension in the ligament); one or all of these techniques may be used. Participants will be positioned on an exam table supine, seated, lateral decubitus, prone, or in their position of greatest comfort for the procedure. Treatment will last approximately 45 minutes.
15907666|NCT03590236|Other|Graded exposure therapy|Patients included in this group received graded exposure therapy consisting on counselling, a graded activity through postural exercises and individual training focused on 5 activities selected by the patients. The treatment will include 5 sessions added to the 12 sessions of physiotherapy.
15907667|NCT03590236|Other|Physiotherapy|Physiotherapy intervention will include soft tissue mobilizations and myofascial release combined with deep-pressure massage to decrease trigger point-related pain and tension. In addition joint mobilization and muscle energy techniques will be included.
15907668|NCT03590223|Procedure|Coronary Bypass Revascularization|analysis of perioperative major cardiovascular events in diabetic patients
15907669|NCT03590210|Drug|Trabectedin|Cycle 1 to 16 1.5mg/m² IV over 24 hours, q3w
15907670|NCT03590210|Drug|Nivolumab|Cycle 2 to 16 240 mg IV over 30 minutes, q3w
15907671|NCT03590197|Drug|Melatonin 3 mg|Melatonin 3 mg/ day with Valproate
15907672|NCT03590197|Other|Placebo|Placebo with Valproate
15907673|NCT03590171|Drug|Bortezomib|Patients randomised to the HR-B arm receive induction, consolidation with the modified ALL R3 protocol. In this arm, patients are randomized to receive Bortezomib together with the ALL R3 protocol during induction. Administration of Bortezomib: 1.3 mg/m2 as intravenous bolus or subcutaneously (SC, at the discretion of the treating physician) on days 1 and 4 of weeks 1 and 3.
15907674|NCT03590158|Behavioral|TRF|Participants will be instructed to consume their habitual diet within a self-selected 10 hour period every day.
15907675|NCT03590145|Diagnostic Test|Clinical examination|Standardized clinical examination consisting of pain provocation test, including palpation, muscle resistance and stretch test.
15907676|NCT03590132|Behavioral|Strong African American Families Program|SAAF is a 7 session family skills training program
15907677|NCT03590132|Behavioral|Strong African American Families--Teen Program|SAAF-T is a 5 session family skills training program
15907678|NCT03590119|Drug|Lutetium Lu 177-DOTATATE|Intra-arterial infusion of Lu-177-DOTATATE
15907679|NCT03590106|Behavioral|Peer Recovery Support Program|See above
15907680|NCT03590093|Procedure|Periodontal surgery|After local anesthesia injection an intrasulcular flap is designed according to minimally invasive techniques. After flap elevation, careful removal of granulation tissues from the periodontal defects is performed. Scaling and root planing of the involved dental roots is ensured and finally suture is placed.
15907681|NCT03590093|Procedure|EMD application|Application of Pref-Gel for 2 minutes and then the application on Enamel Matrix Derivatives on the surgically exposed root surface
15907682|NCT03590080|Drug|Methylprednisolone|
15907683|NCT03590067|Other|Questionnaire|The data will be collected through a questionnaire that will be obtained through an interview between the investigator and the parent or the legal guardian
15907684|NCT03590054|Drug|Abexinostat|"Dose Level
~-1: 20 mg/m2 PO BID days 1-4, 8-11 of every 21 day cycle
~30 mg/m2 PO BID days 1-4, 8-11 of every 21 day cycle
~45 mg/m2 PO BID days 1-4, 8-11 of every 21 day cycle"
15907685|NCT03590054|Biological|Pembrolizumab|200 mg IV on day 1 of every 21 day cycle
15907712|NCT03589820|Other|artificial liver support system|Patients will receive the treatment of artificial liver support system using combination of plasma exchange and continuous hemodiafiltration and internal medicine. The volume of fresh frozen plasma used in plasma exchange is 2000 millilitre. The time for continuous hemodiafiltration is about 8 hours.
15907688|NCT03590028|Other|Early Nephrology Consult (ENC)|The electronic risk prediction algorithm (ESTOP-AKI) will interface with electronic medical data to determine the likelihood for the patient to develop AKI. Early Nephrology Consult (ENC) will be implemented. A nephrologist will assess the subject and consult with their care team to advise a treatment plan during the hospitalization.
15907689|NCT03590028|Other|Standard of Care (SOC)|Subjects will receive nephrology consultation at the typical timepoint after symptoms of AKI appear.
15907690|NCT03590015|Other|Old invitation letter|Invitation Letter written by researchers/doctors
15907691|NCT03590015|Other|New invitation Letter|Invitation Letter written in simple sentences and a sequential structure of basic information in the rewritten information Letter
15907692|NCT03590002|Device|Electronic ICU Medical Transfer Tool|Patient transfers of care from the ICU to inpatient wards prepared using the electronic ICU medical transfer tool within the health zone's clinical information system, Sunrise Clinical Manager.
15907693|NCT03589989|Other|ENDS (vaporizer/e-cig) and smoking cessation counseling|Participants in the intervention group will receive an ENDS and nicotine-containing e-liquids, which they will be allowed to use ad libitum. Additionally, they will receive smoking cessation counseling. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 6-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6 months, participants will be asked to come to a final clinical visit.
15907694|NCT03589989|Other|Smoking cessation counseling|Participants in the control group will receive smoking cessation counseling only. Participants will be allowed to additionally use nicotine replacement therapy. All participants will be followed over a 6-month period. Smoking cessation counseling will be provided in person at the first clinical visit and then over the phone at the target quit date one week later and again at week 2, 4 and 8 after the target quit date. After 6 months, participants will be asked to come to a final clinical visit.
15907695|NCT03589976|Drug|Sirolimus 2 MG|Dose will be adjusted trhoughout this trial based on sirolimus plasma levels and the presence of drug-related adverse events.The maximum dose will be 6mg/day.
15907696|NCT03589976|Other|Placebo|Patients receiving placebo will undergo analog sham level measurements and the number of tablets will be also adjusted to maintain the blinding of the trial.
15907697|NCT03589963|Behavioral|Postnatal Lactation Support|In-home breastfeeding support delivered by professional lactation consultants and provision of a high-quality breast pump
15907698|NCT03589950|Drug|anlotinib plus chemotherapy|Anlotinib (12mg QD PO d1-14, 21 days per cycle), Docetaxel (75mg/m2 IV d1)/Pemetrexed (500 mg/m2 IV d1), q21d/S-1 (80-120mg/day,depending on body surface area; days 1-28 in a 6-week cycle)
15907699|NCT03589950|Drug|chemotherapy|Docetaxel (75mg/m2 IV d1)/Pemetrexed (500 mg/m2 IV d1), q21d/S-1 (80-120mg/day,depending on body surface area; days 1-28 in a 6-week cycle)
15907700|NCT03589924|Procedure|Immediate IBBR+TiLoop®Bra|Patients will receive immediate implant reconstruction following mastectomy using TiLoop®Bra
15907701|NCT03589924|Procedure|Immediate-delayed IBBR+TiLoop®Bra|Patients will receive immediate-delayed implant reconstruction following mastectomy using TiLoop®Bra
15907702|NCT03589898|Drug|Gabapentin|Single dose of gabapentin 900 mg
15907703|NCT03589885|Drug|Placebo 2 mL auto-injector|"All Placebo patients until week 8 (included): 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4 and 8.
~PASI 90 responders at week 12: 2 mL auto-injector placebo + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and every 4 weeks thereafter until week 48.
~PASI 90 non-responders at week 12: 2 mL secukinumab 300 mg auto-injector + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48"
15907704|NCT03589885|Drug|Placebo 1 mL prefilled syringe|"All Placebo patients until week 8 (included): 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4 and 8.
~PASI 90 responders at week 12: 2 mL auto-injector Placebo + 2x 1 mL prefilled syringe Placebo s.c. at weeks 12, 13, 14, 15, 16 and every 4 weeks thereafter until week 48.
~PASI 90 non-responders at week 12: 2x 1 mL secukinumab 150 mg prefilled syringe + 2 mL auto-injector Placebo s.c. at weeks 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48"
15907705|NCT03589885|Drug|Secukinumab 2 mL auto-injector|2 mL secukinumab 300 mg auto-injector + 2x 1 mL prefilled syringe Placebo s.c. at randomization, weeks 1, 2, 3, 4, 8, 12, 13, 14, 15 , 16 and 4-weekly thereafter until week 48
15907706|NCT03589885|Drug|Secukinumab 1 mL prefilled syringe|2 x 1 mL secukinumab 150 mg prefilled syringe + 2 mL auto-injector Placebo s.c. at randomization, weeks 1, 2, 3, 4, 8, 12, 13, 14, 15, 16 and 4-weekly thereafter until week 48
15907707|NCT03589872|Diagnostic Test|Fine motor dexterity test, nine hole peg test|The nine hole peg test will be performed under two different task (1)single task, (2)adding a cognitive task
15907709|NCT03589833|Drug|Tripterygium Wilfordii|Oral Tripterygium Wilfordii 20mg thrice daily for 24 weeks.
15907710|NCT03589833|Drug|Methotrexate|Oral methotrexate 7.5-15mg per week for 24 weeks. The starting dose was 7.5mg per week, then increased to 15mg (max 0.3mg/Kg) per week in 4 weeks. Folic acid at the dose of 5 mg per week were applied to all participants.
15907711|NCT03589833|Drug|Yisaipu|Yisaipu, a Tumor Necrosis Factor Receptor Fusion Protein, was subcutaneously injected at a dose of 50 mg once a week for 24 weeks.
15907902|NCT03588403|Radiation|IMRT|Intensity modulated radiotherapy
15907713|NCT03589807|Biological|A/H7N9|Monovalent split 2017 A/H7N9 Inictivated Influenza Virus vaccine containing the HA and NA from low pathogenic avian influenza A/Hong Kong/125/2017 (H7N9) and the PB2, PB1, PA, NP, M and NS from A/Puerto Rico/8/1934 (H1N1).
15907714|NCT03589807|Drug|AS03|AS03 oil-in-water emulsion adjuvant.
15907715|NCT03589807|Biological|Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013|Monovalent split 2013 A/H7N9 Inavtivated Influenza Virus vaccine containing the HA and NA from avian influenza A/Shanghai/2/2013 (H7N9) and the PB2, PB1, PA, NP, M and NS from A/Puerto Rico/8/1934 (H1N1).
15907716|NCT03589807|Other|Phosphate Buffered Saline (PBS) diluent|Diluent for Influenza Virus Vaccine.
15907717|NCT03589794|Other|AP10-602|Glucopyranosyl Lipid A -liposome-Quillaja Saponaria 21 (GLA-LSQ).
15907718|NCT03589794|Other|Malaria challenge|Exposure to mosquitoes infected with P. falciparum.
15907719|NCT03589794|Biological|rCSP|The rCSP malaria vaccine is a recombinant full-length P. falciparum circumsporozoite protein comprised of an amino terminus that binds heparin-sulfate proteoglycans, a four-amino-acid repeat region and a carboxy-terminus that contains a thrombospondin-like Type I region domain.
15907720|NCT03589781|Dietary Supplement|Mikei Red Reishi Essence EX|Dosage is 490 mg per capsule, 3 capsules twice a day with food or water. Total of 6 capsules per day.
15907721|NCT03589781|Dietary Supplement|Placebo|Matching placebo. Consume 3 capsules twice a day with food or water. Total of 6 capsules per day.
15907722|NCT03589768|Biological|Tetanus and Diphtheria Toxoids Adsorbed|Used for active immunization of adults and children 7 years of age and older against diphtheria and tetanus.
15907723|NCT03589768|Biological|Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum hydroxide|A sterile isotonic suspension of tetanus and diphtheria toxoids and pertussis antigens adsorbed on Aluminum hydroxide.
15907724|NCT03589755|Behavioral|Mindfulness meditation|The intervention consist of a weekly session of mindfulness meditation provided by a clinical psychologist trained in this area. She will provide weekly session to a group of 10 patients at a time for a total of 8 weeks. Upon completing the course, the other 10 people will start
15907725|NCT03589742|Device|AblaView® Ablation Catheter|The AblaView® Ablation Catheter is a regular RF ablation catheter with the same physical characteristics and the same biocompatible materials, with an 8 French (2.66 mm) sheath and 180º deflection angle. The tip of the catheter has 15 holes distributed around it where the irrigation will be delivered into the patient's blood. The front irrigation hole will deliver at the same time the infrared light for the OCR system.
15907726|NCT03589729|Drug|Cladribine|Given IV
15907727|NCT03589729|Drug|Cytarabine|Given IV
15907728|NCT03589729|Drug|Dexrazoxane Hydrochloride|Given IV
15907729|NCT03589729|Drug|Gemtuzumab Ozogamicin|Given IV
15907730|NCT03589729|Drug|Idarubicin|Given IV
15907731|NCT03589716|Other|Vital Moto Mod|All participants receive vital signs measurement using the Vital Moto Mod device and reference devices. The vital signs measured are blood pressure, heart rate, respiratory rate, oxygen saturation and temperature.
15907732|NCT03589716|Other|Welch Allyn Connex Spot Vital Signs Monitor|This is the FDA approved reference device to measure heart rate, SpO2 and temperature.
15907733|NCT03589716|Other|Capnostream 20 Portable Bedside Capnograph|This is the reference device to be used to obtain etCO2 waveforms for respiratory rate assessment.
15907734|NCT03589716|Other|Welch Allyn 767 Mobile Aneroid Sphygmomanometerand 3M Littmann Master Classic II Teaching Stethoscope|These reference devices will be used together for blood pressure measurements.
15907735|NCT03589716|Other|Scifit 1000R cycle ergometer|This is the device that will be used for exercise testing
15907736|NCT03589703|Other|APA|Light touch using vaccaria seeds on specific points of the ear.
15907737|NCT03589703|Other|Comparison Group (CG-1)|Light touch using vaccaria seeds on different points of the ear (compared to the APA group).
15907738|NCT03589703|Other|Enhanced Educational Control Group (CG-2)|No contact with the subject. Participants in the enhanced educational control group will be given the cLBP educational booklet.
15907739|NCT03589690|Dietary Supplement|Alpha lipoic acid|22 Patients will consume 600 mg Alpha lipoic acid for 12 weeks .
15907740|NCT03589690|Dietary Supplement|Placebo|Participants will be supplemented with 600 mg/day placebo (Starch).
15907741|NCT03589651|Drug|Retifanlimab|"Part 1: INCMGA00012 at the protocol-defined starting dose administered intravenously every 4 weeks, with dose escalation to determine the maximum tolerated dose.
~Part 2: INCMGA00012 at the recommended dose from Part 1."
15907742|NCT03589651|Drug|Epacadostat|"Part 1: Epacadostat at the protocol-defined starting dose administered orally twice daily, with dose escalation to determine the maximum tolerated dose.
~Part 2: Epacadostat at the recommended dose from Part 1."
15907743|NCT03589651|Drug|INCB050465|Part 1: INCB050465 at the protocol-defined starting dose administered orally once daily, with dose escalation to determine the maximum tolerated dose. Part 2: INCB050465 at the recommended dose from Part 1.
15907744|NCT03589638|Device|Direct laryngoscope|Endotracheal intubation was applied by anesthesiologist wtih direct laryngoscope. SAP (systolic arterial pressure), DAP (diastolic arterial artery pressure), MAP (mean arterial pressure) were measured before and 5 minutes after intubation, , Heart rate (HR), SPO2 (oxygen saturation by pulse oximetry), PI (perfusion index), and intraocular pressure values measured by the eye clinician using the device.
15907745|NCT03589638|Device|C-MAC videolaryngoscope|Endotracheal intubation was applied by anesthesiologist wtih direct laryngoscope. SAP (systolic arterial pressure), DAP (diastolic arterial artery pressure), MAP (mean arterial pressure) were measured before and 5 minutes after intubation, , Heart rate (HR), SPO2 (oxygen saturation by pulse oximetry), PI (perfusion index), and intraocular pressure values measured by the eye clinician using the device.
15907746|NCT03589638|Device|McGrath videolaryngoscope|Endotracheal intubation was applied by anesthesiologist wtih direct laryngoscope. SAP (systolic arterial pressure), DAP (diastolic arterial artery pressure), MAP (mean arterial pressure) were measured before and 5 minutes after intubation, , Heart rate (HR), SPO2 (oxygen saturation by pulse oximetry), PI (perfusion index), and intraocular pressure values measured by the eye clinician using the device.
15907789|NCT03589235|Device|A Platelet-Rich Fibrin dressing|A Platelet-Rich Fibrin dressing (PRF) will be applied in both donor and receiving sites after the free gingival graft.
15907790|NCT03589235|Device|A non-eugenol-based dressing|A non-eugenol-based dressing (Coe-Pak™) will be applied in both donor and receiving sites after the free gingival graft.
15907747|NCT03589625|Other|Solar Suitcase|"The intervention is a Solar Suitcase. The Solar Suitcase comes with: 2 LED lights, 1 battery, 1 aluminum glass 100 watt solar panel, 2 rechargeable LED headlamps, 1 universal cell phone charger, 1 USB adapter, 1 fetal Doppler, 1 AA/AAA battery charger and expansion box (provides 2 additional lights).
~Installers will teach health workers how to use and maintain the Solar Suitcase on the day of installation. Within one week following installation, the contractor will contact the facility over the phone and/or in-person to check if there are any problems with the Suitcase. Additional checks will be made to ensure the solar suitcase is functioning and being used properly."
15907748|NCT03589599|Other|Flavored tobacco|Effects of flavored tobacco
15907749|NCT03589599|Other|Non-flavored tobacco|Effects of non-flavored tobacco
15907750|NCT03589586|Other|DermACELL AWM|DermACELL AWM is a sterile, ready to use acellular dermal matrix
15907751|NCT03589560|Drug|Biodentine|a procedure used to regenerate a pulp-dentine complex that restores functional properties of this tissue, fosters continued root development for immature teeth, and prevents or resolves apical periodontitis.
15907752|NCT03589560|Drug|Mineral Trioxide Aggregate|a procedure used to regenerate a pulp-dentine complex that restores functional properties of this tissue, fosters continued root development for immature teeth, and prevents or resolves apical periodontitis.
15907753|NCT03589547|Drug|Durvalumab|Durvalumab10mg/kg Q2 weeks (+/- 4 days) for a total of 12 months (maximum of 26 treatments total)
15907754|NCT03589547|Radiation|SBRT|"SBRT boost will consist of 2 fractions delivered to the primary tumor only, over 1-2 weeks between the first and second treatments with durvalumab.
~The dose will consist of 20Gy (2 fractions of 10Gy)
~*3 fractions are allowed for centrally located tumors"
15907755|NCT03589534|Diagnostic Test|home pregnancy test|Each participant will use 4 different home pregnancy tests
15907756|NCT03589521|Behavioral|ABCT_Military|15 Weekly Couple Therapy Sessions
15907757|NCT03589508|Behavioral|In-person sessions: ABCP_P|6 weekly sessions of alcohol prevention conducted in person.
15907758|NCT03589508|Behavioral|Video conference sessions: ABCP_T|6 weekly sessions of alcohol prevention conducted by video conference.
15907759|NCT03589495|Drug|N Acetyl L Cysteine|100 mg/kg n acetyl cysteine dissolved in dextrose5%
15907760|NCT03589495|Other|dextrose 5%|
15907761|NCT03589482|Device|Electrical Impedance Tomography|Electrical impedance tomography (EIT) is a new technique that enables real-time visualization of the distribution of ventilation at the bedside. This technique allows clinicians and investigators to immediately determine how applying higher or lower PEEP levels affect stress and strain in the lung. The investigators propose to apply this new technique to test a strategy for finding the optimal level of PEEP that prevents lung injury and improves outcomes in critically ill patients.
15907762|NCT03589482|Other|ExPRESS-derived PEEP level|The ExPRESS algorithm is a traditional approach to selecting PEEP based on respiratory mechanics.
15907763|NCT03589469|Drug|Loncastuximab tesirine|intravenous infusion
15907764|NCT03589456|Other|No intervention|There are no interventions associated with this registry as it is purely observational.
15907765|NCT03589443|Drug|Multiplexed heptapeptides|Heptapeptides QRH and KSP
15907766|NCT03589430|Other|Laboratory investigations ( protein C, protein S , antithrombin III)|laboratory investigations ( protein C , protein S , antithrombin)
15907767|NCT03589417|Other|Assessments with Biodex Balance System®|Postural Stability, limits of stability and fall risk tests will be applied with the Biodex Balance System®
15907768|NCT03589404|Device|rso2|The regional oxymetry probe will be placed in the abdominal region of the umbilicus in the middle clavicular line before the disease operation begins.
15907769|NCT03589391|Device|LOR measurement via device|The epidural technique is totally performed in a sterile field without any harm to the patient. The LOR measurement is monitored via the bespoke device used during the epidural procedure.
15907770|NCT03589378|Procedure|PEAF|PEAF that is therapeutic plasma exchange (TPE) with 20ml/kg/d Fresh frozen plasma (Blood pump: 120ml/min, replacement pump 20ml/kg/min, dialysate pump 0ml/kg/min, waste pump 20ml/kg/min, plasma exchange 1 hour) plus plasma filtration adsorption (PFA ) with acute multitherapeutic system( AMPLYA™ ITALY) ≥30ml/min lasting 15 hours plus High volume plasma diafiltration (HVPDF) with CUREFLO™(ACF180W Japan) or Ultraflux® (AV1000S Fresenius Germany) Blood pump: 120ml/min, replacement fluid pump 2000ml/h, dialysate pump 2000ml/h, waste pump 4000ml/h,and with high-volume plasma diafiltration for 15 hours）in the first 3 days. the treatment after three days later is same as the control group.
15907771|NCT03589365|Other|Magnetic resonance imaging (MRI)|"Compare the left ventricular mass of a young adult population born prematurely (Prema group) to that of a group of young adults born at term (Witness group
~The measurements made during this examination are:
~Coronary Reserve Presence of fat in the myocardium Left ventricular mass Left ventricular volume
~The measurements made during this examination are:
~Coronary Reserve Presence of fat in the myocardium Left ventricular mass Left ventricular volume"
15907772|NCT03589339|Drug|NBTXR3|Single intra Tumoral injection
15907773|NCT03589326|Drug|Ponatinib|Ponatinib Tablets.
15907774|NCT03589326|Drug|Imatinib|Imatinib Tablets.
15907775|NCT03589326|Drug|Vincristine|Vincristine IV injection.
15907776|NCT03589326|Drug|Dexamethasone|Dexamethasone Tablets.
15907777|NCT03589326|Drug|Cytarabine|Cytarabine IV infusion.
15907778|NCT03589326|Drug|Methotrexate|Methotrexate IV infusion.
15907779|NCT03589326|Drug|Prednisone|Prednisone Tablets.
15907780|NCT03589313|Drug|GLPG3067 single dose|GLPG3067 film coated tablets provided at Day 1.
15907782|NCT03589287|Biological|Chondrochymal®|Allogeneic Bone Marrow Derived Mesenchymal Stem Cells
15907783|NCT03589274|Behavioral|I-FS-CBT|12 manual-guided sessions of I-FS-CBT
15907784|NCT03589274|Behavioral|G-FS-CBT|12 manual-guided sessions of G-FS-CBT
15907785|NCT03589261|Device|MRI (magnetic resonance imaging)|Fluid challenge will be performed with 500 ml of intra venous NaCl (0.9%). Hepatic blood flow measurement will be performed using MRI.
15907786|NCT03589248|Diagnostic Test|GIF score|assessment by GIF score
15907787|NCT03589248|Diagnostic Test|US score|assessment by ultrasonography score
15907788|NCT03589235|Procedure|A free gingival graft|A free gingival graft will be used for the treatment of gingival recession
15907792|NCT03589222|Drug|Daratumumab|daratumumab at dose of 16 mg/Kg iv weekly on days 1, 8, 15 and 22 during the first two cycles; on days 1 and 15 (Q2W) during the cycles 3 to 6; and on day 1 (Q4W) thereafter
15907793|NCT03589222|Drug|Bortezomib|bortezomib will be given via subcutaneous at dose of 1.3 mg/m2 on days 1, 8, 15 and 22 starting from the first cycle and on days 1 and 15 (Q2W) since cycle 9
15907794|NCT03589222|Drug|Dexamethasone|dexamethasone is 20mg (IV) when given on days that daratumumab is administered (as pre-infusion medication) plus 20 mg of dexamethasone (VO) the day after and the dose of dexamethasone is 40mg (VO) on days when daratumumab is not administered
15907795|NCT03589196|Procedure|Ejaculation Preserving Photoselective Vaporization|Ejaculation Preserving Photoselective Vaporization
15907796|NCT03589196|Procedure|Ejaculation Preserving Plasma Kinetic Vaporization|Ejaculation Preserving Plasma Kinetic Vaporization
15907797|NCT03589196|Procedure|Ejaculation Preserving Transurethral Resection Of The Prostate|Ejaculation Preserving Transurethral Resection Of The Prostate
15907798|NCT03589170|Diagnostic Test|Opportunistic atrial fibrillation screening|Opportunistic pulse palpation and/or ECG at least once a year when they visit doctors or nurse for other reasons.
15907799|NCT03589157|Device|drug-coated balloon (DCB) combined with spot stenting of drug-eluting stent (DES)|using drug-coated balloon (DCB) combined with spot stenting of drug-eluting stent (DES) for treating diffuse coronary artery lesions
15907800|NCT03589157|Device|drug-coated balloon (DCB) combined with second-generation of drug-eluting stent (DES)|using drug-coated balloon (DCB) combined with second-generation DES for treating diffuse coronary artery lesions
15907801|NCT03589131|Procedure|Total Operative time|Investigators compare the preparation time of the procedure in the operating room and the actual operative time
15907802|NCT03589131|Procedure|Margin assessment|In this intervention investigators measure the proximal, distal and the important circumferential radial margin away from the tumor to determine if this arm is oncologically safe or not.
15907803|NCT03589131|Procedure|Conversion rate to open surgery|In this interversion investigators try to measure how much is this arm feasible to completely perform the procedure whether robotically or laparoscopically without conversion to open surgery
15907804|NCT03589131|Procedure|Baseline demographics|These include gender, age, ASA and BMI. All these data are analyzed and compared in both groups
15907805|NCT03589131|Procedure|Preoperative data|"These include distance of the tumor from the anal verge, clinical stage, whether preoperative chemoradiation CRT, presence of residual tumor after CRT. All were analyzed and compared"
15907806|NCT03589131|Procedure|Postoperative data|These include pathological stage, number of harvested lymph nodes and immediate postoperative outcome within one month (days of return of bowel function, days of hospital stay, complications, if any, like anastomotic leakage, ileus,wound problems and others, rate of reoperation, rate of readmission & 30-days mortality. All were analyzed and compared
15907807|NCT03589118|Other|Qi Gong sessions|13 sessions of Qi Gong in a 9 weeks period
15907808|NCT03589105|Drug|Ocrelizumab 300 mg|Two doses of 300 mg infusion administered 14 days apart.
15907809|NCT03589105|Drug|Ocrelizumab 600 mg|A single does of 600 mg infusion administered 24 weeks after the initial dose.
15907810|NCT03589092|Genetic|Next generation sequencing (NGS)|NGS Panel, Whole exome/genome sequencing
15907811|NCT03589079|Genetic|Sanger and/or Next Generation Sequencing (NGS)|NGS panel, whole exome / genome sequencing (WES/WGS)
15907812|NCT03589066|Drug|LY03003|28 mg intramuscular suspension
15907813|NCT03589053|Device|Limb remote ischemic conditioning|The LRIC treatment consisted of 5 cycles of bilateral upper limb ischemia for 5 minutes followed by reperfusion for another 5 minutes performed twice a day for a total of 90 consecutive days.The procedure was performed by using an electric autocontrol device with cuffs that inflated to a pressure of 200 mmHg during the ischemic period and deflated during the reperfusion.
15907814|NCT03589053|Device|Control group|Participants in the control group receive both sham LRIC and standard clinical therapy.
15907815|NCT03589040|Drug|Etonogestrel 68Mg Implant|Etonogestrel single-rod subdermal implant (68mg/rod) will be administered to all study participants
15907816|NCT03589040|Drug|rilpivirine|Oral rilpvirine 25mg
15907817|NCT03589040|Drug|darunavir|Oral darunavir+ritonavir 600/100mg
15907818|NCT03589027|Drug|Levonorgestrel two rod sub-dermal implant|Levonorgestrel (75 mg/rod), 2 rods (150 mg) inserted subdermally
15907819|NCT03589027|Drug|Rilpivirine|Oral ripilvirine 25mg once daily
15907820|NCT03589027|Drug|Darunavir+Ritonavir|Oral DRV/r 600/100mg twice daily
15907821|NCT03589014|Drug|Propranolol|Patients randomized to the experimental arm will receive propranolol on top of standard recommended treatment for CCM. Initial oral dose of 40 mg bid will be uptitrated to 80 mg bid in the absence of excessive bradycardia or hypotension. Doses as low as 10 mg bid and up to 160 mg bid, 20 to 320mg daily, are acceptable according to tolerability.
15907822|NCT03589001|Other|Activity modification|Activity modification, exercises and gradual return to sport
15907823|NCT03588988|Drug|Dexmedetomidine IV infusion|Patients who underwent spine, hip or femur surgery and who were admitted to the ICU after institutional exhalation were randomly assigned to the DEX group and the control group. Both groups can be combined with remifentanil for appropriate postoperative analgesia. The DEX group injects DEX at 0.2 ug / kg / hr from 9 pm to 7 am. At this time, the patient's blood pressure, oxygen saturation and cardiopulmonary function are continuously monitored.
15907824|NCT03588988|Drug|Normal saline|Patients who underwent spine, hip or femur surgery and who were admitted to the ICU after institutional exhalation were randomly assigned to the DEX group and the control group. Both groups can be combined with remifentanil for appropriate postoperative analgesia. The control group is inoculated with saline solution. At this time, the patient's blood pressure, oxygen saturation and cardiopulmonary function are continuously monitored.
15907827|NCT03588962|Biological|In-stent restenosis|Patch tests for the metals applicated in each of the patients
15907828|NCT03588949|Dietary Supplement|Dietary Supplement with L-carnitine (FertilHom)|1 stick of the TDS (vitamins, trace elements with carnitine) will be given 1 time daily in the evening before meals for 6 months or until pregnancy, depending whatever comes first
15907903|NCT03588390|Drug|BI 1323495|Low strength tablet
15907829|NCT03588949|Dietary Supplement|Control Dietary Supplement|1 stick of the TDSwill be given 1 time daily in the evening before meals for 6 months or until pregnancy, depending whatever comes first
15907830|NCT03588936|Drug|Nivolumab (.25 mg/kg)|Participants will receive Nivolumab at one of two dose levels every 2 weeks for 4 treatments.
15907831|NCT03588936|Drug|Tocilizumab|Participants will receive 2 doses of tocilizumab
15907832|NCT03588936|Drug|Nivolumab (.5 mg/kg)|Participants will receive Nivolumab at one of two dose levels every 2 weeks for 4 treatments.
15907833|NCT03588923|Drug|SH229|tablet, oral, 400 mg once daily for 3 days
15907834|NCT03588923|Drug|Placebos|tablet, oral, once daily for 3 days
15907835|NCT03588923|Drug|SH229|tablet, oral, 600 mg once daily for 3 days
15907836|NCT03588923|Drug|Placebos|tablet, oral, once daily for 3 days
15907837|NCT03588923|Drug|SH229|tablet, oral, 800 mg once daily for 3 days
15907838|NCT03588923|Drug|Placebos|tablet, oral, once daily for 3 days
15907839|NCT03588910|Drug|Acetaminophen|50 tablets of acetaminophen 500mg (1-2 tablets every 6 hours as needed)
15907840|NCT03588910|Drug|Ibuprofen 600 mg|25 tablets ibuprofen 600mg (1tablet every 6 hours as needed)
15907841|NCT03588910|Drug|Oxycodone|The number of tablets of oxycodone prescribed is the only difference between the two arms.
15907842|NCT03588897|Dietary Supplement|Nutridrink Multi Fibre|Dietary supplementation of 300 kcal for 14 days
15907843|NCT03588884|Drug|Calcifediol Oral Capsule|Capsule, daily
15907844|NCT03588884|Drug|Calcifediol Oral Product|Capsule, once a month
15907845|NCT03588884|Drug|Cholecalciferol|Capsule, once a month
15907846|NCT03588884|Drug|Paricalcitol Oral Capsule|Capsule, daily
15907847|NCT03588871|Other|Dental bleaching with PaintOn Plus VivaStyle|Procedure of tooth bleaching using products with 6% hydrogen peroxide or its equivalent, specifically the PaintOn Plus Vivastyle 6% HP (Ivoclar Vivadent)
15907848|NCT03588871|Other|Dental Bleaching impact in quality of life with PaintOn Plus Vivastyle|Evaluation of oral quality of life after dental bleaching treatment with PaintOn Plus Vivastyle 6% HP (Ivoclar Vivadent) using an oral quality of life measuring questionnaire, specifically the Oral Health Impact Profile-14
15907849|NCT03588871|Other|Dental bleaching with Opalescence GO|Procedure of tooth bleaching using products with 6% hydrogen peroxide or its equivalent, specifically the Opalescence GO 6% HP (Ultradent)
15907850|NCT03588871|Other|Dental Bleaching impact in quality of life with Opalescence GO|Evaluation of oral quality of life after dental bleaching treatment with Opalescence GO 6% HP (Ultradent) using an oral quality of life measuring questionnaire, specifically the Oral Health Impact Profile-14
15907851|NCT03588871|Other|Dental bleaching with Opalescence PF|Procedure of tooth bleaching using products with 6% hydrogen peroxide or its equivalent, specifically the Opalescence PF 16% CP (Ultradent)
15907852|NCT03588871|Other|Dental Bleaching impact in quality of life with Opalescence PF|Evaluation of oral quality of life after dental bleaching treatment with Opalescence PF 16% CP (Ultradent) using an oral quality of life measuring questionnaire, specifically the Oral Health Impact Profile-14
15907853|NCT03588858|Other|structured interview questionnaires|"Module (1): Socio-demographic characteristics
~Module (2) :Occupational history
~Module (3): Presence of work related injuries and diseases by history and observation.
~Module (4): Food frequency questionnaires (FFQ) during the past week.
~Module (5): Mental health screening: Self-reporting questionnaire 20 questions for assessment of mental health status of children."
15907854|NCT03588845|Other|Treatment Protocol|Protocol treatment sites will be expected to see the patient within a pre-specified window of time. The doctors at that site will apply the treatment algorithm and will make decisions about response to treatment based on the algorithm and on specific patient answers to questionnaires. The treatment protocol will only be made available to IRBs, not to any site personnel before randomization. This was derived from a survey of rheumatologists in many countries and gastroenterologists, mostly in North America, who were asked multiple questions about how they would treat and follow up patients with suspected SIBO. Successful treatment is a response on GSS of no diarrhea plus a total GSS of < 5.
15907855|NCT03588845|Other|Standard of Care|Physicians randomly assigned to standard of care will also be informed of their patients who met eligibility criteria. They will not be aware of the detailed treatment protocol but will be informed of which medications are in the protocol eg antibiotics, prokinetics etc. They will be free to contact the patients at their convenience and to treat them in any way they deem suitable, preferably using these medications but at doses and frequencies according to their own wishes.
15907856|NCT03588832|Diagnostic Test|Evaluation Upper Extremity patterns.|The procedure involves evaluating subjects who meet the eligibility criteria and agree to participate in the study by signing informed consent. The study includes a measurement, applying a registration form, the Barthel scale and the FIM scale.
15907857|NCT03588819|Radiation|SABR|26 Gy in 2 fractions to the prostate and DIL dose of up to 32 Gy in 2 fractions of MR-guided SABR delivered 1 week apart
15907858|NCT03588806|Drug|Xtampza ER (oxycodone)|Following baseline assessments, subjects will have their current opioid medication changed to Xtampza ER (oxycodone) for the duration of the study.
15907859|NCT03588793|Other|Two Point Discrimination|Validity of mechanism in phantom limb pain i.e. cortical reorganisation to be tested using comparison of data from interventions above
15907860|NCT03588767|Drug|Vitamin D3 + anabolic substance|Prospectively enrolled patients with polytrauma, administration of vitamin D3 + anabolic substance
15907861|NCT03588767|Other|No Vitamin D3 + anabolic substance|Retrospectively analyzed group of patients, no Vitamin D3 + anabolic substance administration
15907862|NCT03588754|Drug|Propranolol|Propranolol Extended Release (160mg/day).
15907863|NCT03588754|Drug|Placebo|Placebo pill administered orally.
15907864|NCT03588741|Drug|Turoctocog alfa|"Intravenous (i.v., under the skin) administration.A maximum dose of 200 IU/kg daily.
~The maximum treatment period for this trial is 24 months and the patient(s) will be called for visit to the clinic every 3rd month."
15907865|NCT03588728|Other|Transcranial Direct Current Stimulation|Transcranial direct current stimulation targeting the right inferior frontal gyrus
15907866|NCT03588728|Behavioral|Cognitive Remediation (CR)|Cognitive exercises on a computer designed to increase attention, memory, and processing speed.
15907904|NCT03588390|Drug|BI 1323495|Middle strength tablet
15907905|NCT03588390|Drug|BI 1323495|High strength tablet
15907867|NCT03588715|Drug|Pegylated Interferon alpha 2b (peg-IFN-α2b)|Pegylated Interferon alpha 2b (peg-IFN-α2b) will be administered weekly via subcutaneous route.
15907868|NCT03588715|Drug|3BNC117 + 10-1074|Broadly Neutralizing Antibodies - Sequential, separate IV infusions of 3NBC117 + 10-1074.
15907869|NCT03588702|Device|RF and PEMF treatment|Treatment with Venus Legacy LB2 body applicator
15907870|NCT03588689|Procedure|Continuous fascia iliaca block|Regional nerve block performed under ultrasound guidance. A catheter will be left in place to allow ongoing infusion of local anesthetic.
15907871|NCT03588689|Drug|Ropivacaine|Ropivacaine local anesthetic will be used for the fascia iliaca block
15907872|NCT03588676|Other|Melatonin|5mg Melatonin
15907873|NCT03588676|Other|Placebo|5mg Placebo capsule
15907874|NCT03588663|Device|Baseline Bionic Leg Assessment|The 'Bionic Leg' (BL) [Alter G, Fremont, CA, USA; approved by the Food and Drug Administration (FDA) in 2014], is an externally-wearable, battery-operated robotic device that assists patients and therapists during rehabilitation by providing adjustable and progressive functional mobility training. A patient or therapist can programme the BL to provide motor assistance during sit-to-stand exercises, over-ground walking, and stair climbing, with either more or less robotic-assistance, as desired by the therapist. As the BL increases stability and actively engages the affected leg during functional tasks, it enables patients to undertake more repetitions of specific tasks than when not wearing a BL.
15907875|NCT03588663|Other|Baseline Control Condition Assessment|Participants will complete identical tasks as that undertaken with the Bionic Leg, but will complete the tasks without wearing the Bionic Leg.
15907876|NCT03588663|Other|Training|Participants will take -part in a 30-minute training session whilst wearing the Bionic Leg. The training programme will ask participants to engage in a variety of walking, balance and stair exercises. The training programme will include a 15-minute rest period after completion of the 30 minutes of exercises. This will take 45 minutes in total.
15907877|NCT03588663|Other|Follow-up Assessment|45 minutes after the baseline assessment, immediately following the Training programme, the following tests (PCI, TUG, postural sway, 6-min walk, sit-to-stand) will be completed. These tests will be undertaken whilst not wearing the Bionic Leg. It is anticipated that this session will last approximately 2 hours.
15907878|NCT03588650|Drug|HLX20|a Human Monoclonal Antibody Targeting Programmed Death Ligand-1 (PD-L1) Protein
15907879|NCT03588637|Other|No intervention|No intervention
15907880|NCT03588624|Device|TearCare|The TearCare procedure includes the delivery of thermal energy to the external surface of the eyelids for 15 minutes, immediately followed by manual expression of each eyelid.
15907881|NCT03588611|Drug|Bivalirudin|0.75mg/kg+ 1.75 mg/kg▪h for the duration of PCI;
15907882|NCT03588611|Drug|Bivalirudin|0.6mg/kg+ 1.75 mg/kg▪h for the duration of PCI;
15907883|NCT03588598|Drug|SHC014748M|a selective PI3Kδ inhibitor
15907884|NCT03588585|Procedure|Tension|Tension applied to catheter and taped firmly to leg.
15907885|NCT03588585|Procedure|NO TENSION|Foley balloon will be taped loosely to the leg and not placed on tension. All other care will remain the same
15907886|NCT03588572|Drug|Venlafaxine hydrochloride capsules|The patients in venlafaxine group begin to take the venlafaxine hydrochloride capsules after the first visitation(the first day after randomization), each containing venlafaxine 75mg, 1 capsule per day, until 4 weeks after randomization
15907887|NCT03588559|Diagnostic Test|Blood Pressure Measurement|Measurement blood pressure by Transtek BPM TMB-1591-A-002 and reference device.
15907888|NCT03588533|Drug|Trastuzumab|"Trastuzumab (Herzuma) 8mg/kg loading over 90min (1st cycle)
~Trastuzumab (Herzuma) 6mg/kg maintenance over 30min (2nd cycle~ ) every 3 weeks"
15907889|NCT03588533|Drug|Capecitabine|- Capecitabine 1000mg/m2 p.o. bid D1-D14 every 3 weeks
15907890|NCT03588533|Drug|Cisplatin|- Cisplatin 60~100mg/m2 i.v. D1 every 3 weeks
15907891|NCT03588520|Diagnostic Test|Home Blood Pressure Monitoring|Patients randomly assigned to the HBP-guided management group will perform home BP monitoring for 7 days with the use of a validated self-inflating automatic oscillometric device (HEM 705 CP, Omron Healthcare). Home BP monitoring will be performed according to the currently available European Society of Hypertension guidelines at the baseline visit and will be repeated 1 week before the prespecified follow-up visits (at Month 1, Month 2 and Month 4). Patients randomly assigned to the control group will receive conventional management of hypertension based on office BP recordings obtained with the same BP monitor (HEM 705 CP, Omron Healthcare) during the same prespecified follow-up visits.
15907892|NCT03588507|Combination Product|PPF+NCHA bone graft substitute|nanocrystalline hydroxyapatite bone graft is a a newly developed HA containing about 65% water and 35% nanostructured apatite particles. This gave the nanocrystalline hydroxyapatite bone graft many advantages such as providing a close contact with the surrounding tissues, bioresorbability and extremely high number of nano-sized particles and molecules on the surface .
15907893|NCT03588494|Combination Product|concurrent chemoradiotherapy (CCRT)|"Chemotherapy: Cisplatin (50 mg/m2) on days 1, 8, 29, and 36 and etoposide (50mg/m2) on days 1～5 and 29～33.
~Radiotherapy: Thoracic radiotherapy (TRT) started with a linear accelerator (6MV-X) on the first day of chemotherapy.A minimum dose of 60 Gy (2 Gy per fraction, Monday～Friday) was delivered, and a range of 60-66 Gy in 2 Gy fractions was allowed."
15907894|NCT03588494|Drug|Endostar for one cycle|Endostar(15mg/m2) was durative transfused during the normalization window of the first chemoradiotherapy cycle(days -5～-1).
15907895|NCT03588494|Drug|Endostar for two cycles|Endostar(15mg/m2) was durative transfused during the normalization window of the first and the second chemoradiotherapy cycles(days -5～-1 and 24～28).
15907896|NCT03588481|Device|DESyne X2|Novolimus-eluting stent
15907897|NCT03588468|Other|Electrophysiological biomarkers|Motor and sensory nerve conduction study will be performed on median, ulnar, tibialis, peroneal and sural nerves.
15907898|NCT03588468|Other|MRI biomarkers|T1, T2, STIR and magnetisation transfer ratio (MTR) will be performed unilaterally on the thigh and the leg.
15907899|NCT03588429|Drug|Sevoflurane|Anesthesia was maintained with sevoflurane in patients undergoing standardized nociceptive stimulus (long-lasting tetanic stimulus of the ulnar nerve; 30 s, 50 mA, 50 Hz, square-wave).
15907900|NCT03588429|Drug|Isoflurane|Anesthesia was maintained with isoflurane in patients undergoing standardized nociceptive stimulus (long-lasting tetanic stimulus of the ulnar nerve; 30 s, 50 mA, 50 Hz, square-wave).
15907901|NCT03588403|Radiation|TOMO|Tomotherapy
15907909|NCT03588377|Device|Pulse Oximetry|"Intervention clusters:
~On LHW's regular visits to households of their catchment area, they will daily screen for severe pneumonia and check oxygen level in blood using a pulse oximeter in all under <5 children with symptoms of cough or difficulty breathing
~Case definition:
~Birth - 6 days: Fast breathing +/- Low oxygen in blood <92% (Hypoxemia)
~7 days - 59 months: Fast breathing and/or Chest In-drawing + Any one danger sign: (Low oxygen in blood <92% (Hypoxemia), Refusing to eat, Vomiting continuously, Convulsions, Lethargy/ Unconsciousness, Stridor."
15907910|NCT03588364|Other|Osteopathic Manipulation|Osteopathic manipulation involves a number of different manual techniques. These include muscle inhibition; myofascial release; muscle energy stretch; counterstrain; facilitated positional release ; osteopathy in the cranial field ; balanced ligamentous tension/ligamentous articular strain; one or all of these techniques may be used. Participants will be positioned on an exam table supine, seated, lateral decubitus, prone, or in their position of greatest comfort for the procedure.
15907911|NCT03588351|Drug|chitosan nanoparticles gel|intracanal medicament
15907912|NCT03588351|Drug|chitosan gel|intracanal medicament
15907913|NCT03588351|Drug|chlorhexidine gluconate|intracanal medicament
15907914|NCT03588338|Drug|Perfalgan|For postoperative pain
15907915|NCT03588338|Drug|Control|For postoperative nausea and vomiting
15907916|NCT03588325|Diagnostic Test|CBC-DIFF with MDW, PCT, CRP|Tests will be run to determine early identification of sepsis and added value of the combination of tests. Results will not be used to manage patients
15907917|NCT03588312|Procedure|Aortoplasty using autologous pericardial patch|hypoplastic aortic arch repair using a glutaraldehyde treated, autologous pericardial patch.
15907918|NCT03588299|Drug|BAY2599023 (DTX201)|Single escalating doses with 4 dose steps; Single intravenous (IV) administration.
15907919|NCT03588286|Procedure|Electrophysiology study (EPS)|EPS will be performed in all patients in the intervention arm with programmed ventricular stimulation with a drive train of 8 beats at 400 ms with up to 4 extrastimuli and stimulation from the right ventricular apex with current delivered at twice pacing threshold. The end point for stimulation will be sustained monomorphic ventricular tachycardia (VT) lasting > 10 seconds. If sustained monomorphic VT with cycle length (CL) ≥200ms is induced by ≤4 extra stimuli the EPS result will be considered positive for inducible VT.30 Ventricular fibrillation or flutter with CL<200ms will be considered a negative result. The Programmed Ventricular Stimulation (PVS) induction will be repeated a second time if the initial induction was negative for VT.
15907920|NCT03588286|Other|Standard Care|The control group receive ongoing standard care according to the practise of their institution. This includes discharge from hospital as per their treating physician and follow up as usual in the community. Participants in this group would be eligible to receive an ICD according to the standard practise of their cardiologist (guideline recommendations are after 40 days following myocardial infarction or 90 days following revascularisation only in patients with left ventricular ejection fraction less than or equal to 30% or less than or equal to 35% in the presence of heart failure).
15907921|NCT03588286|Procedure|Cardiac Magnetic Resonance (CMR)|CMR will be performed on either a 1.5-T or 3-T scanner. Gadolinium contrast (Gd-BOPTA, MultihanceTM) will be administered for quantification myocardial perfusion imaging with subsequent late gadolinium enhanced imaging after a total dose of 0.1mmol/kg. Exclusion criteria specific for CMR will include pregnancy, renal insufficiency defined as glomerular filtration rate (GFR) <30 mL/min, contraindication to MRI (including non-MRI compatible pacemaker/ICD or metal implants, non-MR safe prosthetic heart valves), claustrophobia which cannot be controlled via standard methods (benzodiazepines and/or sedative antihistamine administration) and prior allergic reaction to gadolinium-based contrast agent.
15907922|NCT03588273|Drug|Amoxil 500 MG Oral Capsule|
15907923|NCT03588260|Other|no intervention - cross-sectional observational only|no intervention - cross-sectional observational only
15907924|NCT03588247|Procedure|transcatheter aortic valve implantation|Patients with severe aortic valve stenosis undergo transcatheter aortic valve implantation
15907925|NCT03588221|Procedure|four sets of hand hygiene measurements per participant|"Six-step hand hygiene technique with an application time of 30 seconds
~Six-step hand hygiene technique with an application time of 15 seconds
~Three-step hand hygiene technique with an application time of 30 seconds
~Three-step hand hygiene technique with an application time of 15 seconds"
15907926|NCT03588208|Other|Progressive resistance training program|Progressive resistance training program were performed twice a week for 12 weeks. The charge intensity was progressively increased from 40% to 80% of 1 repetition maximum. The following muscle groups were worked: trunk flexors and extensors, elbow flexors and extensors, knee flexors and extensors, hip abductors and adductors and shoulder abductors. In addition to strength training.
15907927|NCT03588208|Other|Educational Program|Structured education program were performed during one hour class once a week for five weeks
15907928|NCT03588195|Other|Educational Program|Educational program consist in 5 consecutive sessions held once a week, with a duration of 60 minutes each class and at the end of the last class, a booklet was delivered for each patient with all the contents of the classes. This group also received Transcutaneous Nerve Electro-Stimulation twice weekly, for 5 weeks for 40 minutes each session
15907929|NCT03588195|Device|Transcutaneous Nerve Electro-Stimulation|Transcutaneous Nerve Electro-Stimulation performed twice weekly, for 5 weeks for 40 minutes each session
15907930|NCT03588182|Other|Virtual Reality Experience|Virtual reality visualization and experience of a 3-dimensional relaxing nature scene with the accompanying audio.
15907931|NCT03588169|Dietary Supplement|semi-structured interviews|"About 30 minutes and touching on the following subjects:
~perception of hospital meals
~patient representation of ONS
~taking ONS and feelings about it"
15907932|NCT03588156|Drug|Benapenem|Dose-escalation For 11 level dose groups A1 ~ A11(each 62.5mg/kg, 125mg/kg, 250mg/kg, 500mg/kg, 1000mg/kg 60min infusion, 1000mg/kg 30min infusion, 2000mg/kg 60 min infusion, 2000mg/kg 30min infusion, 3000mg/kg, 4000mg/kg), 10 subjects (8 for the study drug and 2 for placebo) are randomized to each dose group
15907933|NCT03588156|Drug|Placebo|Placebo
15907934|NCT03588143|Device|Electrical stimulation|Two kinds of electrical stimulation (TENS and HVPS) and placebo intervention
15907935|NCT03588130|Drug|EscharEx (5% EX-02 formulation)|Active arm
15907936|NCT03588130|Drug|Gel Vehicle|Control arm
15907937|NCT03588130|Drug|Non-surgical standard of care (NSSOC)|Santyl (Enzymatic debridement) or commercially approved Hydrogel
15937148|NCT03364309|Drug|Placebo|Administered SC
15907938|NCT03588117|Behavioral|Physician-supervised nonsurgical weight management program|Participants of a physician-supervised nonsurgical weight management program were observed as they received weekly in-person coaching sessions with licensed clinicians. In-person coaching sessions were focused on educating participants on strategies to manage their weight and adopt a healthy lifestyle. Prescribed diets were individualized based on each participant's behavior, level of physical activity, and total energy expenditure. Supplements, appetite suppressant medications, and compounded injections were used to control appetite and/or boost energy during a period of low-caloric intake. The program was generally divided into three phases: Acute, Short-Term Maintenance, and Wellness.
15907939|NCT03588104|Device|POWER2DM system|This system consists of two components: 1) the web-based Shared Decision Making Dashboard, used to set self-management goals together with a health care professional with the use of both short- and long-term predictive computer simulation models, and 2) the POWER2DM Self-Management Support System as a mobile application and webpage, used to support behavioural change in DM self-management. The system is fed with data from an activity tracker, a glucose monitor and manual data entry. Power2DM support will be provided as an adjunct to usual care
15907940|NCT03588104|Other|Usual care|Usual care as given to diabetes patients by the patient's diabetes care team.
15907941|NCT03588091|Drug|Pyrotinib|pyrotinib: 400mg orally daily;
15907942|NCT03588091|Drug|Placebo Oral Tablet|placebo: 400mg orally daily;
15907943|NCT03588091|Drug|Trastuzumab|trastuzumab:8mg/kg iv load followed by 6mg/kg iv 3-weekly for a total of 4 cycles;
15907944|NCT03588091|Drug|Docetaxel|docetaxel:after the biological window, 100mg/m2 for a total of 4 cycles
15907945|NCT03588078|Drug|APR-246|Azacitidine at maximum tolerated dose. APR246 at the Dose limited Toxicity (DLT) dose
15907946|NCT03588078|Drug|Azacitidine|azacitidine is administered subcutaneously (SC) or via IV at 75 mg/m2
15907947|NCT03588065|Diagnostic Test|FMS|"The evaluation of the risk of sports injury was obtained from the score in the Functional Movement Screen test suite.
~The Functional Movement Screen (FMS) is a battery of tests that allows the integral assessment of the risk of injury, evaluating the basic patterns of movement and motor control through the performance of seven tests in which the combination of force is reflected muscle, flexibility, range of motion range, coordination, balance and proprioception"
15907948|NCT03588065|Other|TICS|The educational activities were directed to soccer players belonging to Equidad, Bogotá-Colombia. Computerized media were used within the reach of footballers, applied with professionals of physical activity sciences under blind study methodology, using the new tendencies of Information and Communication Technologies (ICT) in Health Education. The investigators counted on the advice of the group manager of knowledge of the secretary of the district of the city of Bogotá. In the educational intervention seven aspects were addressed, distributed in four weekly modules for a total of four months
15907949|NCT03588065|Other|CONFERENCE|The face-to-face educational intervention (conference) consisted of four educational sessions, distributed over four weeks during the sports transition period of the Equity sub-20 team. During these sessions, workshops (conferences) were held with the players following a face-to-face methodology . All these activities were concerted with the multidisciplinary team of the Equity football team and were carried out by the researcher at the University of La Sabana, a physiotherapist, who was studying the needs of the prevention of musculoskeletal injuries in football.
15907950|NCT03588052|Procedure|VISTA using PRF|"Vertical vestibular access incision will be done through the periosteum to elevate a subperiosteal tunnel, exposing the facial osseous plate. The tunnel will be extended beyond mucogingival junction and at least one or two teeth beyond the teeth indicated for root coverage to mobilize gingival margins and allow for low-tension coronal repositioning of the gingiva.
~Freshly prepared platelet-rich fibrin will be secured in the tunnel to cover the root dehiscence, coronal advancement of gingival margin and suturing to the facial aspect of each tooth to avoid apical relapse of the gingival margin during the initial phase of healing. The vertical incision will be then approximated and sutured"
15907951|NCT03588052|Procedure|VISTA using SCTG|"Vertical vestibular access incision will be done through the periosteum to elevate a subperiosteal tunnel, exposing the facial osseous plate. The tunnel will be extended beyond mucogingival junction and at least one or two teeth beyond the teeth indicated for root coverage to mobilize gingival margins and allow for low-tension coronal repositioning of the gingiva.
~Subepithelial connective tissue graft will be secured in the tunnel to cover the root dehiscence, coronal advancement of gingival margin and suturing to the facial aspect of each tooth to avoid apical relapse of the gingival margin during the initial phase of healing. The vertical incision will be then approximated and sutured"
15907952|NCT03588039|Drug|Oraxol|Oral paclitaxel will be supplied in capsules and oral HM30181AK-US will be supplied in tablets
15907953|NCT03588039|Biological|Pembrolizumab|Intravenously administered
15907954|NCT03588026|Drug|rVA576|6 months of treatment, rVA576 plus SOC. Followed by a further 3 months of rVA576 plus SOC. In total, 9 months on rVA576 plus SOC.
15907955|NCT03588026|Other|Standard of care (SOC)|6 months on SOC followed by 3 months of treatment with rVA576 plus SOC. In total, 3 months on rVA576 plus SOC.
15907956|NCT03588013|Other|Nutritional education|4 week home delivered educational program that will focus on breast feeding and complimentary feeding. If child remains WHZ < -2 at by 9 months of age families will be shown 10 minute educational video detailing best practices for complimentary feeding.
15907957|NCT03588013|Dietary Supplement|Ready to Use Therapeutic Food|If child remains WHZ < -2 despite nutritional education then will be managed according to Pakistan's Community Management of Acute Malnutrition protocol. This will include provision of ready to use therapeutic food (RUTF) to the child at home with close follow up. Utilization of the RUTF will be monitored closely by bi-weekly home visits.
15907958|NCT03588013|Procedure|Upper gastrointestinal endoscopy with biopsy|If child remains at WHZ < -2 despite educational and dietary interventions, then will undergo medical evaluation for assessment of need for more advanced workup of malnutrition, including UGI endoscopy at AKUH. Results of the advanced work up, including the UGI endoscopy, will guide future management of these children.
15907959|NCT03588000|Other|Strengthen self-monitoring of blood glucose|Strengthen self-monitoring of blood glucose by Internet mobile terminal（APP）.
15907960|NCT03587987|Device|Neopff|manual ventilation
15907961|NCT03587987|Device|rPap|Manual ventilation
15907962|NCT03587974|Behavioral|REACH-VIETNAM|Family caregiver education, stress-reduction, and skill-training related to providing care for a person with Alzheimer's disease
15907963|NCT03587961|Drug|Symdeko|explore the use of off-label CFTR modulators that may affect CFTR function in patients with CFTR mutations that are not currently approved for these drugs.
15907964|NCT03587948|Diagnostic Test|Diabetes mellitus|Children and adolescents who is diagnosed with diabetes will be involved in case-group, and others will be involved in control-group.
15907965|NCT03587935|Other|3D-Colonoscopy Progression Score|The score is based on a movement analysis of the colonoscope from anus until max insertion(cecum). It is scaled from 0-1000. A score of zero equals an incomplete procedure and a score of 1 is a very poor score but the cecum was reached. Increasing score represents better technical performance with a maximum score of 1000.
15907966|NCT03587935|Other|3D-Colonoscopy Retraction Score|The score is based on a movement analysis of the colonoscope from cecum to the anus. It is scaled from 0-1000. A score of zero equals a very poor score, Increasing score represents better technical performance with a maximum score of 1000.
15907967|NCT03587922|Device|Fantom|Treatment of den ovo coronary lesions
15907968|NCT03587909|Procedure|Phacoemulsification Cataract SUrgery|Phacoemulsification in eyes with shallow anterior chamber (<2.5mm depth)
15907969|NCT03587909|Procedure|Femtosecond Cataract Surgery|Femtosecond Cataract Surgery in eyes with shallow anterior chamber < 2.5mm
15907970|NCT03587896|Behavioral|Self Help Plus|5-session psychosocial intervention
15907971|NCT03587883|Other|Cocoa flavanols I|Capsules containing Mars Cocoa Extract manufactured by the Cocoapro® process and containing 300mg of cocoa flavanols per capsule consumed for 2 weeks.
15907972|NCT03587883|Other|Control I|Cocoa-based, flavanol-free, control-matched capsules consumed for 2 weeks.
15907973|NCT03587883|Other|Cocoa flavanols II|Capsules containing Mars Cocoa Extract manufactured by the Cocoapro® process and containing 300mg of cocoa flavanols per capsule consumed for 2 weeks.
15907974|NCT03587883|Other|Control II|Cocoa-based, flavanol-free, control-matched capsules consumed for 2 weeks.
15907975|NCT03587870|Other|Enteral nutrition with Fresubin Intensive|Comparison of intermittent (experimental) vs continuous (standard, active comparator) enteral nutrition on muscle wasting in critically ill patients
15907976|NCT03587857|Other|Mobile Health Application|This mobile health app is a modular, adaptive, and personalized intervention delivered via a mobile phone. It is grounded in the Information Motivation Behavioral Skills (IMB) model. It was created in collaboration with YLWH (18-29 years-old) using a Human-Centered Design approach to help improve engagement in HIV care among this age group.
15907977|NCT03587844|Drug|brentuximab vedotin|MF/SS Brentuximab vedotin 0.9 mg/kg 0R 1.2 mg/kg.
15907978|NCT03587844|Drug|brentuximab vedotin|LyP Brentuximab vedotin 0.9 mg/kg2
15907979|NCT03587844|Drug|brentuximab vedotin|MF/SS prior brentuximab vedotin-Brentuximab vedotin dose to be determined from Cohort 1
15907980|NCT03587831|Procedure|Vertical Sleeve Gastrectomy|Surgical Procedure: Vertical Sleeve Gastrectomy
15907981|NCT03587831|Behavioral|Lifestyle Modification Counseling|Behavioral Intervention: Lifestyle Modification Counseling
15907982|NCT03587818|Other|person-centred communication|The intervention aimed to actively make use of a person-centred approach to support patients undergoing CRC surgery to be prepared for surgery, discharge and recovery in relation to CRC. This was accomplished through person-centred communication, which was based on a standardized dialogue tool with tailored written information material (component I), in combination with an approach for professionals to facilitate person-centred communication (component II) in consultations.
15907984|NCT03587792|Procedure|stapedectomy|Stapedectomy as described in literature with stapes removal, Carbon Dioxide (CO2) laser platinectomy and placement of a prothesis(piston) between the incus long process and the stapes footplate
15907985|NCT03587779|Drug|Sevoflurane|Throughout the study period, anesthesia is maintained with sevoflurane of age-corrected equivalent minimum alveolar concentration.
15907986|NCT03587779|Drug|Desflurane|Throughout the study period, anesthesia is maintained with desflurane of age-corrected equivalent minimum alveolar concentration.
15907987|NCT03587766|Drug|Fexinidazole|Drug: fexinidazole (FEXI)
15907988|NCT03587766|Drug|Placebo Oral Tablet|Drug: fexinidazole
15907989|NCT03587753|Other|Dietary fatty acid partitioning|There is no intervention as such, just a physiological assessment of the partitioning and oxidation of two different types of dietary fatty acids
15907991|NCT03587714|Diagnostic Test|HCV RT-PCR|HCV ribonucleic acid by reverse transcriptase polymerase chain reaction (RT-PCR)
15907992|NCT03587701|Drug|Anakinra 100Mg/0.67Ml Inj Syringe (Period 1)|pre-filled syringes of anakinra 100mg/0.67mg will be provided and will be self-administered by patients daily during first 42 days of treatment (Period 1)
15907993|NCT03587701|Drug|Placebo injection (Period 1)|pre-filled matching placebo injections will be provided and will be self-administered by patients daily during first 42 days of treatment (Period 1)
15907994|NCT03587701|Drug|Anakinra 100Mg/0.67Ml Inj Syringe (Period 2)|pre-filled syringes of anakinra 100mg/0.67mg will be provided and will be self-administered by patients daily during next 42 days of treatment (Period 2)
15907995|NCT03587701|Drug|Placebo injection (Period 2)|pre-filled matching placebo injections will be provided and will be self-administered by patients daily during next 42 days of treatment (Period 2)
15907996|NCT03587688|Procedure|mitral valve surgery|pre-, intra- and postoperative data on patients undergoing mitral valve surgery at the Department for Cardiac Surgery of Universitätsspital Basel/ Switzerland since 2009
15907997|NCT03587675|Diagnostic Test|EVH test|
15907998|NCT03587662|Drug|Doxorubicin|Given IV
15907999|NCT03587662|Drug|Doxorubicin Hydrochloride|Given IV
15908000|NCT03587662|Drug|Gemcitabine|Given IV
15908001|NCT03587662|Drug|Gemcitabine Hydrochloride|Given IV
15908002|NCT03587662|Drug|Ixazomib|Given PO
15908003|NCT03587662|Drug|Ixazomib Citrate|Given PO
15908581|NCT03583606|Other|Placebo|0.5 mL normal saline administered via IM injection into the deltoid.
15908004|NCT03587649|Drug|[18F]MNI-1126|"Florbetapir PET imaging will be completed in all healthy volunteers and AD subjects as part of the screening procedures.
~DaTscan SPECT imaging will be completed in those PDsubjects who have not previously had DaTscan imaging as part of the screening procedures."
15908005|NCT03587636|Drug|liposome bupivacaine|interscalene block with liposomal bupivacaine plus bupivacaine
15908006|NCT03587636|Drug|Bupivacaine|interscalene block with bupivacaine
15908007|NCT03587610|Biological|Remedial vaccination|"if the patients vaccinations are up to date: no remedial vaccination is done and the patient is informed of the next remedial vaccination date
~if the patients vaccinations are not up to date: remedial vaccination is realised in the unit in the absence of contraindication, in case of a temporary contraindication the vaccination will be performed on an outpatient basis by the patients primary care provider and he will be given a prescription at hospital discharge for the remedial vaccination."
15908008|NCT03587597|Procedure|socket shield technique|socket shield technique with immediate temporization
15908009|NCT03587597|Procedure|conventional immediate implant placement with immediate temporization|conventional immediate implant placement with immediate temporization
15908010|NCT03587584|Drug|liposomal bupivacaine|Experimental
15908011|NCT03587584|Drug|Bupivacaine|Active Comparator
15908012|NCT03587571|Procedure|Surgical intervention|Open reduction and plate osteosynthesis.
15908013|NCT03587558|Drug|Carvedilol|Patients in this group are taking carvedilol to inhibit outflow tract PVC/VT.
15908014|NCT03587558|Drug|Flecainide|Patients in this group are taking flecainide to inhibit outflow tract PVC/VT.
15908015|NCT03587545|Other|Probiotic nasal spray|Total daily nasal administration of 2*10^8 CFU of probiotic bacteria delivered via 2 servings.
15908016|NCT03587545|Other|Placebo nasal spray|Two servings of nasal administration of placebo nasal spray (not containing probiotic bacteria)
15908017|NCT03587532|Diagnostic Test|Indocyanine green angiography|ICGA will be performed twice during standard esophagectomy: 30 minutes after the stomach graft creation and immediately before the esophagogastric anastomosis. stock dose of 25 mg ICG (Pulsion Medical Systems, Germany) will be diluted to 5 mg/mL with sterile water. An IV bolus of 0.5 mg/kg of ICG will be injected via a central venous catheter. Video data will be obtained with a charge-coupled device (CCD) camera fitted with a light-emitting diode emitting at a wavelength of 760mm (Visera® elite II, Olympus medical system corp, Tokyo, Japan). Images will be recorded starting immediately prior to injection until 3 minutes afterwards.
15908018|NCT03587532|Diagnostic Test|Hemodynamic evaluation|Advanced continuous hemodynamic monitoring during surgery will be performed using a PiCCO® (Pulse index Continuous Cardiac Output, Pulsion Medical Systems, Germany) catheter.
15908019|NCT03587532|Diagnostic Test|Biological and pathological markers of ischemia|"Systemic and local capillary lactate on blood samples
~Mitochondrial Respiratory activity analyses on biopsies at 3 region of interest (ROI)
~Pathological analyses of the biopsies at 3 ROI"
15908020|NCT03587519|Procedure|Early|Early ileostomy closure
15908021|NCT03587519|Procedure|Late|Late ileostomy closure
15908023|NCT03587480|Procedure|TME+LLND|patients in TME+LLND group receive Lateral Lymph Node Dissection (LLND) after Total Mesorectal Excision(TME)
15908024|NCT03587480|Procedure|TME+nCRT|patients in TME+nCRT group receive Neoadjuvant Chemo-radiotherapy (nCRT) before Total Mesorectal Excision(TME)
15908025|NCT03587467|Other|collect fecal specimens|collect fresh fecal specimens of participants
15908026|NCT03587454|Diagnostic Test|Teleglaucoma|Subjects are evaluated through a teleglaucoma protocol then by physical presence in a glaucoma clinic
15908027|NCT03587441|Drug|Neostigmine Methylsulfate|20 µg Neostigmine Methylsulfate intrathecal in 0.2 ml of Dextrose 5% solution
15908028|NCT03587441|Drug|Dextrose 5% in water|intrathecal
15908029|NCT03587428|Drug|Zinc-A toothpaste|Participants received 6.0 grams (g) [± 0.3g] of the Zinc-A toothpaste in the form of slurry, one day per treatment (with at least 2 [generally 7] days between treatments. Participants emptied the contents of the dosing cup into their mouth, swilled the product around their mouth for 2 timed minutes then they expectorated into a sink.
15908030|NCT03587428|Drug|Zinc-B toothpaste|Participants received 6.0 grams (g) [± 0.3g] of the Zinc-B toothpaste in the form of slurry, one day per treatment (with at least 2 [generally 7] days between treatments. Participants emptied the contents of the dosing cup into their mouth, swilled the product around their mouth for 2 timed minutes then they expectorated into a sink.
15908031|NCT03587428|Other|Mineral water|Participants received 6.0g (±0.3g) of mineral water (by weighing out), one day per treatment (with at least 2 [generally 7] days between treatments). Participants emptied the contents of the dosing cup into their mouth, swilled the product around their mouth for 2 timed minutes then they expectorated into a sink.
15908032|NCT03587415|Diagnostic Test|preptin and amylin level|we will take both of group blood samples to compare them serum preptin and amylin
15908033|NCT03587402|Other|Transcutaneous perineal stimulation|Surface stimulation
15908034|NCT03587402|Other|Anal stimulation|Intra-cavitary stimulation
15908035|NCT03587389|Biological|Rotarix vaccine|In this study, the 1st dose of Rotarix vaccine will be administered when infants are at ages between weeks 8-9 and the 2nd dose is 28-37 days after the 1st dose, which means that there is an interval of 28-37 days or 4-5 weeks between doses. A reminding call will be set at about 4 weeks after the 1st dose to remind parents to bring their children back to Hung Vuong Hospital for the 2nd dose of Rotarix to ensure the completion of the 2nd dose of Rotarix vaccine.
15908036|NCT03587376|Drug|Atabecestat|Blood samples will be collected from participants previously treated with atabecestat.
15908037|NCT03587363|Drug|Erdafitinib|Participants will receive 6 mg (2*3 mg tablet) erdafitinib as a single oral dose on Day 1. Participants in Cohort 4 may receive a lower dose if warranted by preliminary safety and PK data from Cohorts 2 and 3.
15908038|NCT03587350|Device|Shimmer monitoring|The shimmer monitor, monitors movement and the range of movement.
15908039|NCT03587337|Other|POEM|Pt. are going to submit a POEM procedure.
15908152|NCT03586765|Other|Female urinary incontinence|Assess prevalence of urinary functional disorders in women of 40 and more, visiting a general practitioner, occupational medicine or health examination center in Puy-de-Dôme. Study conducted for a month using a self-filled survey distributed by secretaries or nurses.
15908040|NCT03587324|Drug|Whole blood aggregometry before and after vascular treatment (ASA/ Clopidogrel).|"To identify possible risk factors demographic data, concomitant medication, laboratory parameters, co-morbidities, severity of the condition and the type of procedure performed are documented.
~Other Name: ASA (aspirin), Clopidogrel (Plavix)"
15908044|NCT03587298|Procedure|Real-Time (Supersonic)- 2D shear wave elastography (rt-SWE)|"The SWE is carried out intercostally. If possible, the patient should hold the breath for 5-10 seconds. So-called colour charts are used, which indicate the derived liver stiffness in colour-coded form. In addition to the visual assessment of these colour charts, the quantitative ROI-based measurement of the SWE in kPa is performed in the hardest appearing areas. The measurement is performed at 5 different sites of the liver parenchyma and all SWE values are recorded."
15908045|NCT03587285|Biological|Tcm+ Goserelin acetate+ Bicalutamide|Autologous Tcm cells administered intravenously on Day 1 and Day 42,3.6mg goserelin acetate injection administered subcutaneously monthly,50 mg bicalutamide administered orally daily
15908046|NCT03587285|Biological|Tcm+Goserelin acetate+Abiraterone acetate|Tcm cells administered intravenously on Day 1 and Day 42,3.6mg goserelin acetate injection administered subcutaneously monthly,1000 mg abiraterone acetate administered orally daily plus 5 mg prednisone administered orally twice daily
15908047|NCT03587272|Drug|Alemtuzumab intravenously, low dose total body irradiation, Sirolimus|"The conditioning regimen (SUN regimen) will consist of alemtuzumab intravenously daily for 5 days (0.03mg/kg on Day -7, 0.1mg/kg on Day -6, 0.3mg/kg on Days -5 to -3) and low dose total body irradiation (TBI) 300 cGY on Day -2 with gonadal shielding if possible. The HSCT graft will be G-CSF mobilized PBSCs with minimum CD34+ of 5 x106/kg recipient weight, goal of 10 x 106/kg (no upper limit). A peripheral blood stem cell (PBSC) graft was selected as it engrafts faster than bone marrow and would lead to shorter period of neutropenia and infection and less thrombocytopenia and need for platelet transfusion.
~GVHD prophylaxis will be sirolimus with a loading dose 3 mg/m2 on day -1. Sirolimus will be continued at 1 mg/m2/day starting on day 0 and dose adjusted to maintain a target trough level 5-15 ng/mL for the first 3 months and 5-10 ng/mL for the remainder of the first year."
15908048|NCT03587259|Diagnostic Test|Tomosynthesis|DBT is a x-ray examination that allows to visualize the breast on 3 planes (3D) and therefore to help to see lesions hardly visible to mammography due to the overlap of glandular tissue.
15908049|NCT03587259|Diagnostic Test|2D mammography|2D mammography is a X-ray examinations used to detect breast cancer in the screening programme.
15908050|NCT03587246|Diagnostic Test|3DTVUS : Uterine peristaltic frequencies|Perform three-dimensional transvaginal ultrasonography To observe uterine peristaltic frequencies in embryo transfer cycles
15908051|NCT03587233|Behavioral|Physical assessment|Besides the demographic features of the participants, the interventions on physical assessment will be performed including weight in kilogram and height in meter; and weight and height will be combined to report body mass index in kg/m2. The waist circumference will be measured to understand the central fattening from costal margins or above umbilicus in cm. If it is measured above 95cm for men and 80cm for women is considered as higher than normal; if higher than 110cm for men and 88cm for women is considered as having risks for obesity, diabetes, cardiovascular diseases etc. Hand and pinch grip power will be assessed. It the elbow is in extension upper extremity power, and if it is flexed at 90 degree and forearm is supported on the table handgrip power is to assess.
15908052|NCT03587233|Device|Analyses of body composition|The analyzes of body composition will be measured with bioelectrical impedance analysis method by a body composition analyzer.
15908053|NCT03587233|Behavioral|physical activity level assessment|The physical activity level will be assessed through the intervention titled with the Turkish version of the 'International Physical Activity Questionnaire-Short Form'. It consists of seven questions searching for the amount of walking and low, moderate and high intensity physical activities as total time in minutes per day and frequency in days per week. Sitting, as a sedentary behavior, will be evaluated separately. The scores will be achieved by the multiplication of the minutes, days and metabolic equivalent time values in a week, and over the last 7 days. Walking score and total weekly walking duration will be calculated as medium and vigorous; the physical activity level will be classified as low, moderate and high level activity.
15908054|NCT03587220|Drug|Capsaicin Topical|Capsaicin patches (dosage form: patch 8% Qutenza) will be applied on 4x4 cm squared areas on the volar forearm. The patches will be left in place for 24h and 3 hours after which they will be removed.
15908055|NCT03587220|Radiation|Ultraviolet-B (UVB) irradiation|Two circular areas (Ø 2 cm) on the forearm are irradiated with 2 x MED (Minimal Erythema Dose) dose of UVB using a calibrated UVB machine (290-320nm wavelength), Saal Mann Multi Tester (Mann Saal, LT SBC 400 Herford, Germany).
15908056|NCT03587220|Other|Histamine 1%|To deliver histamine, standard allergy skin prick test (SPT) lancets are applied. The lancets have a 1 mm shouldered tip adapt to introduce a small amount of test substance extremely locally and approximately at the dermo-epidermal junction.
15908057|NCT03587220|Drug|Lidocaine|Cutaneous anaesthesia will be topically induced by using EMLA cream 5%, a local anaesthetic cream consisting of equal parts of lidocaine and prilocaine (1g contains 25 mg of lidocaine and 25 mg of prilocaine)
15908058|NCT03587207|Biological|MenABCWY vaccine|Two doses administered intramuscularly in the deltoid region of the non-dominant arm.
15908059|NCT03587207|Biological|rMenB+OMV NZ (Bexsero) vaccine|Two doses administered 2 months apart intramuscularly in the deltoid region of the non-dominant arm to subjects randomised to the rMenBOMV+ACWY_S Group, rMenBOMV+ACWY_D Group and rMenBOMV Group
15908060|NCT03587207|Biological|MenACWY (Menveo) vaccine|Two doses administered intramuscularly in the deltoid region of the dominant/non-dominant arm to subjects randomised to the rMenBOMV+ACWY_S Group and rMenBOMV+ACWY_D Group and one dose administered intramuscularly in the deltoid region of the dominant/non-dominant arm to subjects randomised to the MenACWY Group
15908061|NCT03587194|Drug|Otezla|Otezla 30mg BID
15908112|NCT03586921|Behavioral|Psychosocial Group Intervention|The intervention included two psycho-educational sessions with information about depression and anxiety disorders, two sessions on the development of pleasant activities including relaxation exercises, two sessions on solving problems therapy, one session on the problem of overcoming negative thoughts and emotions, one session on relapse prevention, and a final closure and review session which included a small party.
15937785|NCT03359148|Device|Conventional reused ventilator system|
15908062|NCT03587181|Procedure|Cryoablation of the pulmonary veins and myocardial biopsy|"Before intervention blood samples will be collected for biobank storage. After left atrial appendage thrombus exclusion, a cardiac biopsy from intraventricular and interatrial septum will be performed. PV isolation will be performed with cryoablation. Successful PV isolation will be confirmed by the confirmation of bi-directional block. Phrenic nerve function will be assessed in a standard fashion during intervention of the right PVs using high output phrenic nerve pacing from the superior vena cava. Loop recorder implantation will be performed during the same procedure.
~In patients with recurrent atrial tachyarrhythmias an EP study will be performed to assess the mechanism of recurrence. PV reconnections will be re-isolated and linear lesions performed as required."
15908063|NCT03587168|Other|the timed 360° turn test|Turning ability is assessed by using the timed 360° turn test.
15908064|NCT03587168|Other|Berg Balance Scale|Functional balance is assessed by using the Berg Balance Scale.
15908065|NCT03587168|Other|Four Square Step Test|The Four Square Step Test measures dynamic balance.
15908066|NCT03587168|Other|Functional Reach Test|The Functional Reach Test assesses limits of stability.
15908067|NCT03587168|Other|Trunk Impairment Scale|Trunk performance is assessed by using the trunk impairment scale.
15908068|NCT03587168|Other|Timed Up and Go Test|Functional mobility is assessed by using the timed up and go test.
15908069|NCT03587168|Other|Hoehn and Yahr Scale|Disease stage is assessed by the Hoehn and Yahr Scale.
15908070|NCT03587168|Other|Unified Parkinson's Disease Rating Scale|The Unified Parkinson's Disease Rating Scale assesses disease severity.
15908071|NCT03587142|Drug|Buspirone|Buspirone tablet
15908072|NCT03587142|Drug|Placebo|"Sugar pill manufactured to mimic buspirone 10 mg tablet"
15908073|NCT03587129|Drug|Apatinib|An anti-tumor Targeted drug
15908076|NCT03587103|Behavioral|Protocol initiate with A|The BP-lowering medication adjustment and titration will follow A-AC-ACD or A-AD-ADC for individuals randomized to A or two-drug combination therapy with full dose of A in their initial medication assignment.
15908077|NCT03587103|Behavioral|Protocol initiate with C|The BP-lowering medication adjustment and titration will follow C-CA-CAD or C-CD-CDA for individuals randomized to C or two-drug combination therapy with full dose of C in their initial medication assignment.
15908078|NCT03587103|Behavioral|Protocol initiate with D|The BP-lowering medication adjustment and titration will follow D-DA-DAC or D-DC-DCA for individuals randomized to D or two-drug combination therapy with full dose of D in their initial medication assignment.
15908079|NCT03587090|Diagnostic Test|echocardiography|echocardiography by subcostal and transhepatic views
15908080|NCT03587077|Drug|Misoprostol|vaginal application
15908081|NCT03587077|Drug|Placebos|vaginal application
15908082|NCT03587077|Drug|isosorbide mononitrate|vaginal application
15908083|NCT03587064|Device|Conventional 3-lead CRT defibrillator system implantation|Conventional 3-lead(1 atrial and 2 ventricular leads) system implantation
15908084|NCT03587064|Device|2-lead CRT defibrillator system implantation|2-lead (2 ventricular leads with dipole for atrial sensing) DX system implantation
15908085|NCT03587051|Dietary Supplement|Low glycemic index post-exercise diet|Feeding of a low-glycemic index, lentil meal after 90 minutes of walking exercise
15908086|NCT03587051|Dietary Supplement|High glycemic index post-exercise diet|Feeding of a high-glycemic index meal (i.e. instant mashed potatoes, white bread, egg whites) after 90 minutes of walking exercise
15908087|NCT03587038|Drug|OKN 007|400 mg OKN-007/mL in a phosphate buffer
15908088|NCT03587038|Drug|Temozolomide|75 mg/m2
15908089|NCT03587038|Radiation|Photon/Proton IMRT|standard of care treatment to be given 1 to 2 hours after OKN-007
15908090|NCT03587025|Drug|Amitriptyline|Amitriptyline compared with placebo for preemptive analgesia in women after abdominal hysterectomy.
15908091|NCT03587025|Drug|Placebo|Placebo
15908092|NCT03587012|Other|Brain fitness app|Daily tutored sessions of brain exercises on an iPAD (in-person or remote)
15908093|NCT03587012|Other|Brain fitness app with tACS|Daily tutored sessions of brain exercises on an iPAD with simultaneous transcranial alternating current stimulation (tACS)
15908094|NCT03586999|Drug|Nivolumab and EPOCH|Nivolumab injection is to be administered as an IV infusion. DA-EPOCH dosage calculations will be based on the patient's body surface area (BSA) at baseline, recommend using Mosteller formula and administered through IV. Dose adjustments at the beginning of each cycle do not need to be made unless there has been a >10% weight gain or loss. Patients receive six 21 day cycles of the medications.
15908095|NCT03586986|Diagnostic Test|Brain MRI|Perform brain MRI; draw blood; fill out bioscreen questionnaire; perform SDMT
15908096|NCT03586973|Drug|Cabozantinib|Cabozantinib tablet
15908097|NCT03586960|Device|Peak Force Measurement|Force will be measured at 5,10, and 30 minutes
15908098|NCT03586947|Drug|Vitamin D3 400 UNT Oral Capsule|50,000 IU of vitamin D once a week for 8 weeks, 1500-2000 IU/day.
15908099|NCT03586934|Drug|Acetaminophen|Acetaminophen Tablet
15908100|NCT03586934|Drug|Celecoxib 200mg|Celecoxib Tablet
15908101|NCT03586934|Drug|Celecoxib 400 mg|Celecoxib Tablet
15908102|NCT03586934|Drug|Ropivacaine|Ropivicaine nerve block (injection)
15908103|NCT03586934|Drug|Ketorolac|ketorolac injection
15908104|NCT03586934|Drug|Acetaminophen Injectable Product|Acetaminophen injection
15908105|NCT03586934|Drug|Oxycodone|oxycodone tablet
15908106|NCT03586934|Drug|Tramadol|Tramadol tablet
15908107|NCT03586934|Drug|Morphine Injectable Solution|Morphine Patient Controlled Analgesia
15908108|NCT03586934|Drug|hydrocodone bitartrate and acetaminophen|Norco tablet
15908109|NCT03586934|Drug|Morphine|morphine injection
15908110|NCT03586934|Drug|Oxycodone Hydrochloride|oxycodone hydrochloride tablet
15908111|NCT03586934|Drug|Meloxicam|meloxicam tablet
15908153|NCT03586752|Other|On-line program|18 minutes on-line video at home and 30 minutes CPR skill practice at scene in 3 days after watching on-line video
15908113|NCT03586921|Other|Enhanced Usual Care|All patients received enhanced primary care: (1) Nurses and doctors from the Family Health Teams were trained by Matrix team mental health professionals on clinical aspects of depression and anxiety. (2) Given the high co-occurrence of anxiety and depression, the intervention was modified from the depression-only Chile model to emphasize co-occurring anxiety and depression in diagnoses, appropriate prescription of anxiolytics and antidepressants. (3) All providers received weekly group or individual consultation with a Matrix team mental health professional, either psychiatrist or psychologist. An qualitative study of participating Petrópolis Family Health Programme doctors and nurses demonstrated their satisfaction with the training.
15908114|NCT03586908|Drug|PHP-201 0.5% ophthalmic solution (topical eye drop)|D1, D7: PHP-201 0.5% topical eye drop OU QD(AM), D2~D6: PHP-201 0.5% topical eye drop OU TID
15908115|NCT03586895|Behavioral|e-Connect|e-Connect
15908116|NCT03586882|Device|Spinal Cord Stimulation|Stimulation provided by the generator to electrodes on the leads inhibits ascending pain signals, thereby decreasing pain perception.
15908117|NCT03586869|Drug|Aldoxorubicin HCl|Aldoxorubicin Hydrochloride
15908118|NCT03586869|Biological|ALT-803|Recombinant human super agonist interleukin-15 (IL-15) complex
15908119|NCT03586869|Biological|ETBX-011|Ad5 [E1-, E2b-]-CEA
15908120|NCT03586869|Biological|ETBX-021|Ad5 [E1-, E2b-]-HER2
15908121|NCT03586869|Biological|ETBX-051|Ad5 [E1-, E2b-]-Brachyury
15908122|NCT03586869|Biological|ETBX-061|Ad5 [E1-, E2b-]-MUC1
15908123|NCT03586869|Biological|GI-4000|RAS yeast
15908124|NCT03586869|Biological|GI-6207|Carcinoembryonic Antigen (CEA) yeast
15908125|NCT03586869|Biological|GI-6301|Brachyury yeast
15908126|NCT03586869|Biological|haNK for infusion|NK-92 [CD16.158V, ER IL-2]
15908127|NCT03586869|Biological|bevacizumab|Recombinant human anti-Vascular Endothelial Growth Factor (VEGF) IgG1 monoclonal
15908128|NCT03586869|Drug|Capecitabine|5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine
15908129|NCT03586869|Drug|Cyclophosphamide|2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
15908130|NCT03586869|Drug|Fluorouracil|5-fluoro-2,4 (1H,3H)-pyrimidinedione
15908131|NCT03586869|Drug|Leucovorin|L-Glutamic acid, N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-, calcium salt
15908132|NCT03586869|Drug|nab-Paclitaxel|Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin
15908133|NCT03586869|Drug|Oxaliplatin|cis-[(1 R,2 R)-1,2-cyclohexanediamine-N,N'] [oxalato(2-)- O,O'] platinum
15908134|NCT03586869|Biological|Avelumab|Recombinant human anti-programmed death-ligand 1 (PD-L1) IgG1 monoclonal antibody
15908135|NCT03586869|Procedure|SBRT|Stereotactic Body Radiation Therapy
15908136|NCT03586856|Device|Nasal mask interface|Nasal masks is a standard interface used for CPAP treatment of newborn infants. The CPAP device allows for easily switching between the nasal prongs or nasal mask interface as well as adjustment of size.
15908137|NCT03586856|Device|Nasal prongs interface|Nasal masks is a standard interface used for CPAP treatment of newborn infants. The CPAP device allows for easily switching between the nasal prongs or nasal mask interface as well as adjustment of size.
15908138|NCT03586843|Drug|JNJ-64565111|JNJ-64565111 SC will be administered on Day 1 of Treatment Periods 1, 2 and 3 as per the assigned treatment sequence in Part A and as ascending doses on Days 1, 8, 15, 22, 29 and 36 in Part B.
15908139|NCT03586830|Drug|JNJ-64565111 Dose Level 1|Participants will receive JNJ-64565111 Dose Level 1 SC once-weekly until Week 12.
15908140|NCT03586830|Drug|JNJ-64565111 Dose Level 2|Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 12.
15908141|NCT03586830|Drug|JNJ-64565111 Dose Level 3|Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 12.
15908142|NCT03586830|Drug|Placebo|Participants will receive matching placebo to JNJ-64565111 SC once-weekly until Week 12.
15908143|NCT03586817|Drug|Palonosetron|75 mcg during the anesthesia
15908144|NCT03586817|Drug|Fosaprepitant|150 mg during the anesthesia
15908145|NCT03586804|Other|dual task|mental and motor tasks will be performed while standing. Motor task: holding mini blocks Mental task: Counting the numbers from 200 to 1
15908146|NCT03586791|Procedure|Pupillometry guided anesthesia|"At least 10 min after anesthesia induction by target-controlled infusion of propofol and remifentanil, baseline values for pupillary diameter is recorded before any surgical procedure.
~During the operation, propofol effect-site target concentration (Ce) is adjusted to maintain the bispectral index (BIS) value between 40 and 60. Remifentanil Ce is adapted every 5 min based on the changes of pupillary diameter. If the pupillary diameter is increased by more than 30% compared to baseline value, remifentanil concentration is increased by 0.5 ng/ml. If the pupillary diameter is maintained between 5 and 30 % change compared with baseline, remifentanil is not modified. In a case of pupillary diameter is decreased less than 5 % change of baseline, remifentanil concentration is decreased by 0.5 ng/ml."
15908147|NCT03586791|Procedure|SPI guided anesthesia|During the operation, SPI value should be maintained between 20 and 50 by changing the infusion rate of remifentanil. Even if the SPI is maintained within the target range, the remifentanil infusion rate is increased by 0.5 ng/ml in a case of the SPI value suddenly arises by more than 10.
15908148|NCT03586791|Procedure|Standard management|"During the operation, propofol effect-site target concentration (Ce) is adjusted to maintain the bispectral index (BIS) value between 40 and 60.
~Remifentanil concentration is controlled by the discretion of the anesthesiologist in charge of the patients."
15908149|NCT03586778|Other|dry needling|Dry Needling targeting the posterior musculature of the thoraco-lumbar spine and hips
15908150|NCT03586778|Other|manual therapy|Manual Therapy(mobilization/ manipulation) to address joint mobility of the thoraco-lumbar spine and hips
15908151|NCT03586778|Other|therapeutic exercise|Exercise designed to improve performance of the paraspinal and abdominal musculature as well as the hip musculature. The exercise portion will also include a stretching program targeting the trunk and hip muscles which have been placed in a shortened position as a result of poor postures.
15908189|NCT03586557|Device|Corticosteroid & Plasma exchange|High-dose intravenous methylprednisolone 1000mg 3~5 days and subsequent taper, combined simultaneous plasma exchange 5 times in all
15908154|NCT03586752|Other|Standard program|60-minute CPR teaching video with practice, 20 minutes of automated electrical defibrillator operation, and a 10-minute discussion with regard to the legal issues associated with bystander CPR in Taiwan
15908155|NCT03586739|Procedure|endovascular angioplasty using covered stents|Primary endovascular angioplasty using one or several covered stents
15908156|NCT03586739|Procedure|endovascular angioplasty using bare metal stents|Primary endovascular angioplasty using one or several bare metal stents
15908157|NCT03586739|Device|Duplex-scan|a Duplex-scan will be performed during patient follow up.
15908158|NCT03586739|Device|computerized tomography scan (CT-scan)|"a CT-scan will be performed in the event of symptoms of recurrence or restenosis as confirmatory exam according to clinical practice during patient follow up.
~The CT-scan will be mandatory at 12 and 24 months if it has not been planned in the current practice follow-up."
15908159|NCT03586739|Device|digital angiography|In case CT-scan cannot be performed (e.g. occurrence of a non-preexisting contra-indication), a digital angiography will be authorised instead to confirm restenosis during patient follow-up.
15908160|NCT03586739|Other|Short Form-36 (SF-36) questionnaire|The patient will complete a quality-of-life questionnaire (SF-36 form) during their follow up.
15908161|NCT03586726|Drug|Balovaptan|"In Period 1, balovaptan was administered alone as a once daily (qd) dose on Days 1 to 10.
~In Period 2, balovaptan was administered as a qd dose on Days 7 to 16."
15908162|NCT03586726|Drug|Rifampicin|In Period 2, 600 mg of rifampicin will be administered alone as a qd dose from Day 1 to Day 6, and as a qd dose on Days 7 to 16.
15908163|NCT03586713|Diagnostic Test|light induced fluorescence camera|The light induced fluorescence intraoral camera works with a visible blue light frequency (wavelength 450 nm) for the illumination of the dental surface and produces an overlapping image of the green fluorescence image on the image of the white light. The green fluorescence image is considered an indicator of healthy dental tissues. The colour of the fluorescence signal is green when the dentin is healthy. The healthy enamel is blue due to the scattered green light of the dentin, despite the lack of a fluorescence signal. On the other hand, caries can be easily detected by dark red fluorescence.
15908164|NCT03586700|Drug|Xiao zhong fang granules|Chinese medicine Xiao zhong fang was Professor Sun Chengxiang's experience formula in Massage Department of Dongzhimen Hospital. The function of the formula is to activate blood circulation and dredge collaterals, tonifying kidney and promoting dampness to soothe the liver and nourish tendons.
15908165|NCT03586700|Radiation|Short wave infrared radiation|Short waves infrared radiation treatment every other day, ensure 3 times in 7 days, 7 days for a course of treatment, continuously for 4 courses.
15908166|NCT03586700|Drug|Placebo Xiao zhong fang granules|Made of starch,dextrin and edible pigment from Dongzhimen Hospital of Beijing university of chinese medicine.
15908167|NCT03586687|Drug|Triamcinolone|Ultrasound guided glenohumeral shoulder joint injection
15908168|NCT03586674|Drug|Lipanthyl|Tablet
15908169|NCT03586674|Drug|Ursogal|suspension
15908170|NCT03586661|Drug|Copanlisib|Given IV
15908171|NCT03586661|Drug|Niraparib|Given PO
15908172|NCT03586648|Device|senofilcon A Multifocal|TEST Lens
15908173|NCT03586648|Device|senofilcon A Sphere|TEST Lens Sphere
15908174|NCT03586648|Device|etafilcon A Multifocal|CONTROL Lens
15908175|NCT03586648|Device|etafilcon A Sphere|CONTROL Lens Sphere
15908176|NCT03586635|Other|neurological exam|"Patients participating in the study are recruited from the investigator's tertiary multiple sclerosis management centre. They are systematically examined neurologically as part of their routine follow-up.
~the patient will be exceptionally examined by two distinct persons, a senior doctor and a junior doctor (internal or external) independently.
~At the end of the neurological examination, each examiner will evaluate the EDSS score in a classical way (using paper definitions) then using the smartphone application"
15908177|NCT03586622|Dietary Supplement|Low FODMAP diet (LFD)|The Low FODMAP diet (LFD) is an acronym for Fermentable Oligo-, Di-, and Monosaccharides And Polyols - all of which are small osmotic active carbohydrates or sugar alcohols that are poorly absorbed in the small intestine and therefore easily fermented by the gut microbiota. The fact that they are fermented rapidly and osmotic active makes them potential and likely candidates for causing luminal distension due to accumulation of gas and water in the intestine.
15908178|NCT03586622|Dietary Supplement|VSL#3®|VSL#3® is a dietary supplement that helps maintain the balance of the intestinal flora. VSL#3® has been recognized and classified as GRAS (Generally Regarded as Safe) by a panel of experts in the USA for both adult and pediatric IBD and IBS patients. VSL#3® is a probiotic food containing 450 billion freeze-dried live lactic acid bacteria and bifidobacteria from 8 different strains per bag/sachet: Streptococcus thermophilus BT01, Bifidobacteria (B. breve BB02, B. longum* BL03, B. infantis* BI04), Lactobacillus acidophilus BA05, Lactobacillus plantarum BP06, Lactobacillus paracasei BP07, Lactobacillus delbrueckii subsp. bulgaricus** BD08; *Recently reclassified as B. animalis subsp. lactis ** Recently reclassified as L. helveticus. The recommended daily dose is 1-2 bags.
15908179|NCT03586609|Drug|Azacitidine|Given SC or IV
15908180|NCT03586609|Drug|Cladribine|Given IV
15908181|NCT03586609|Drug|Cytarabine|Given SC
15908182|NCT03586609|Drug|Venetoclax|Given PO
15908183|NCT03586596|Behavioral|The Decídetext program|Decídetext participants will be directed to the tablet-based software. Participants will receive an interactive education session that will lead them through language-appropriate, culturally-relevant information about stopping smoking, collection of basic smoking history data, and choices/plans about preparing to quit. Quit plans include: 1) choice of quit date, 2) NRT preference, 3) plan to remove smoking cues, 4) identification of trigger situations and 5) choice of suggested coping strategies. Participant data and choices are used to generate a printed 1-page individualized treatment plan. Tablet components, assessment items, audio narrative, brief multimedia instructional video clips, and the printed treatment plan have been developed to address low-literacy levels.
15908184|NCT03586596|Behavioral|Standard Care Control|Educational Material provided as of suggested by American Cancer Society and, the National Cancer Institute
15908185|NCT03586583|Device|FBP|Old processing
15908186|NCT03586583|Device|ISR|New processing
15908187|NCT03586570|Drug|Aprocitentan 25mg|Oral tablets in strength of 25 mg
15908188|NCT03586570|Drug|Placebo|Oral tablets matching aprocitentan tablets
15908219|NCT03586284|Drug|Topical placebo|28 days of topical placebo treatment
15908190|NCT03586557|Drug|Corticosteroid|High-dose intravenous methylprednisolone 1000mg 3~5 days and subsequent taper
15908191|NCT03586544|Drug|Albuterol Sulfate|Participants will inhale 2 puffs of albuterol (90mcg per actuation). After 15 minutes, participants will undergo an exercise induced bronchoconstriction test
15908192|NCT03586544|Behavioral|Interval Warm-up exercise|Participants will undergo eight 30 sec bouts of high intensity exercise with 45 second recovery between bouts. After 15 minutes, participants will undergo an exercise induced bronchoconstriction test
15908193|NCT03586531|Procedure|renal biopsy|Renal biopsy samples will be obtained by a percutaneous method using a spring-loaded Trucut® biopsy needle under real time ultrasound guidance. Biopsy samples will be processed for light microscopy with special staining will be done: Schiff periodic acid, Masson trichrome and methenamine silver.and immunofluorescence studies to evaluate IgA, IgG, IgM, complement C1q and C3, fibrin, and kappa and lambda light chain deposits.
15908194|NCT03586518|Diagnostic Test|Cardiac MRI scan|"A non-contrast cardiac MRI (CMR) scan at 3-Tesla platform (Skyra, Siemens Medical Imaging, Erlangen, Germany).
~This non-contrast CMR scan will principally determine: Left ventricular (LV) mass and volumes/ejection fraction and; fibrosis using T1 mapping."
15908195|NCT03586518|Diagnostic Test|Echocardiogram|Assessments will include: LV size and function as per the American Society of Echocardiography guidelines. In addition specific focus will be paid end-diastolic integrated backscatter measurements.
15908196|NCT03586518|Procedure|Cardiac explantation|A limited post-mortem will be performed to retrieve patients' hearts for preparation and storage at St George's University, London where direct comparison will be made between levels of scarring seen directly under the microscope between that on the MRI scans.
15908197|NCT03586518|Diagnostic Test|48-Hour continuous cardiac monitoring|Attach continuous Holter monitor (Schiller, medilog®AR12 plus/AR4 plus/FD5 plus, Baar, Switzerland) that will start before dialysis and terminate just before the subsequent dialysis treatment 48h later.
15908198|NCT03586518|Diagnostic Test|Blood samples|Collect blood samples from the arterial needle before dialysis. Approximately 30 millilitres of blood will be collected and then be pipetted into cryotubes and frozen at -80°C in an electronically monitored freezer for analysis in batches throughout the study. These samples will be used to investigate the relationship between circulating biomarkers of fibrosis, the MRI scans and the histological samples.
15908199|NCT03586505|Device|Light exposure|"The 6 lights used randomly are :
~482nm =standard blue light illumination,
~650nm,
~675nm,
~700nm,
~750nm
~800nm"
15908200|NCT03586492|Diagnostic Test|CZT SPECT acquisition|CZT SPECT acquisition, with dynamic stress and rest acquisitions to calculate CFR If pathological, coronarography with FFR measurement if necessary In case of intermediate coronary stenosis with medical treatment, SPECT CFR evaluation after one year of treatment
15908201|NCT03586479|Behavioral|Interactive storybook reading|Children will be taught 30 words prior to, during, and after reading a commercially available storybook by an adult.
15908202|NCT03586466|Device|BupreCare|"Subjects will receive their medication in a MedicaSafe device. Medication will be dispensed in accordance with the programmed treatment plan for each subject. Subjects will complete a Check-In remotely each week with their device."
15908203|NCT03586466|Drug|Buprenorphine/naloxone|Subjects will be given buprenorphine/naloxone as a component of Medication Assisted Treatment (MAT).
15908204|NCT03586466|Other|MEMS|Subjects will receive their medication in a MEMS pill bottle.
15908205|NCT03586453|Drug|Osimertinib|"Patients who fulfill eligibility criteria will be entered into the trial to receive Osimertinib.
~After the screening procedures confirm participation in the research study:
~Osimertinib: Oral, Daily 28 day cycle.
~Radiographic assessment: every 2 cycles for first 6 months and then every 3 cycles until disease progression.
~Tumor biopsy between C4 and C8 and at disease progression"
15908206|NCT03586427|Drug|AGN-241751|AGN-241751 administered orally as a single tablet
15908207|NCT03586427|Drug|Placebo|Placebo administered orally as a single tablet
15908208|NCT03586414|Dietary Supplement|MITOQUINOL MESYLATE then placebo|MITOQUINOL MESYLATE then placebo: 'MITOQUINOL MESYLATE' administered twice daily for 4 weeks followed by a washout, then placebo capsule administered twice daily for 4 weeks. Capsules with active product contain 20 mg of 'MITOQUINOL MESYLATE'.
15908209|NCT03586414|Dietary Supplement|Placebo, then MITOQUINOL MESYLATE|'Placebo, then MITOQUINOL MESYLATE' : Placebo administered twice daily for 4 weeks followed by a washout, then 'MITOQUINOL MESYLATE' capsule administered twice daily for 4 weeks. Capsules with active product contain 20 mg of 'MITOQUINOL MESYLATE'.
15908210|NCT03586388|Other|Oral immunotherapy protocol|"In hospital setting: three increasing doses every 30 minutes of 1ml, 5ml and 10ml of cow milk (CM). Oral food challenge (OFC) stopped at 10ml even if no clinical reactions occurred.
~At home: every child will take the dose tolerated in hospital, starting the day after the OFC, for 3-4 weeks.Once reached the dose of 40ml of CM without reactions for at least 2 weeks, families increment the dose of 5 ml every week, till the tolerance of 50 ml, then of 10 ml every week, till the tolerance of 100ml and then, of 10 ml every 3 days till the tolerance of 150 ml of milk."
15908211|NCT03586375|Other|Intensive Support Team Care|Intensive Support Teams (ISTs) are specialist teams which have been advocated for many years as the right services to help people with intellectual disabilities (ID) and challenging behaviour stay in their local communities. They may be staffed by one or more professions, e.g. psychology, nursing, psychiatry, and usually deliver interventions such as positive behaviour support and accept people with ID who are in a crisis when challenging behaviour emerges or provide support when a person is admitted to a local inpatient facility.
15908212|NCT03586336|Device|ReDS-Guided|ReDS measurements will be shared with the treating clinicians who can use the information to guide diuresis and determine the appropriate timing of discharge
15908213|NCT03586336|Device|Usual Care|ReDS measurements will not be shared with the treating clinicians, who will guide diuresis using standard clinical criteria
15908214|NCT03586323|Drug|superior laryngeal nerve block with lidocaine|SLNB was performed with 4 ml of 1.5% lidocaine below the thyroid membrane
15908215|NCT03586310|Device|ear-EEG|soft silicone electrode array placed in each ear (outer ear-canal and concha), connected to a battery powered EEG amplifier.
15908216|NCT03586284|Drug|Valganciclovir Hydrochloride|28 days of oral valganciclovir treatment
15908217|NCT03586284|Drug|Ganciclovir Sodium|28 days of topical ganciclovir solution treatment
15908218|NCT03586284|Drug|Placebo Oral Tablet|28 days of placebo pill treatment
15937786|NCT03359135|Other|Rehabilitation|Rehabilitation during 4 weeks
15908220|NCT03586271|Procedure|trifocal lens|phacoemusification + trifocal lens(AT Lisa tri 839MP) implantation
15908221|NCT03586271|Procedure|bifocal lens 1|phacoemusification +bifocal lens(Diff-aay) implantation
15908222|NCT03586271|Procedure|bifocal lens 2|phacoemusification +bifocal lens (ReSTOR +3.0D) implantation
15908223|NCT03586271|Procedure|bifocal lens 3|phacoemusification +bifocal lens (ReSTOR +2.5D) implantation
15908224|NCT03586258|Behavioral|Neuropsychological testing|Experimental test about cognitive deficit of interest and standard neuropsychological tests
15908225|NCT03586258|Other|Brain Imaging|Anatomical, diffusion, and/or functional MRI
15908226|NCT03586258|Other|Galvanic Vestibular Stimulation (GVS)|Stimulation versus Sham
15908227|NCT03586245|Dietary Supplement|Ferric pyrophosphate|57 Iron isotopically labeled FePP powder.
15908228|NCT03586245|Dietary Supplement|Aspiron|58 Iron isotope intrinsically labeled Aspergillus oryzae.
15908229|NCT03586245|Dietary Supplement|Ferrous sulfate|57 Iron isotopically labeled FeSO4 powder.
15908230|NCT03586232|Dietary Supplement|Arnica Montana|Arnica Montana is from the Asteraceae plant family and is native to the mountain areas in Europe and western North America. It is reported to have anti-inflammatory, antiseptic, and vasodilatory properties and is often used in plastic surgery to help reduce pain, edema, and ecchymosis postoperatively.
15908231|NCT03586232|Dietary Supplement|Bromelain|Bromelain is a protease enzyme derived from the pineapple plant, Ananas comosus, which has been used to reduce swelling, inflammation, and pain and may help to reduce wound healing time.
15908232|NCT03586232|Other|Placebo|A pharmacologically inert preparation
15908233|NCT03586219|Behavioral|Opioid-specific educational patient pamphlets|See prior description
15908234|NCT03586193|Procedure|Pars plana vitrectomy|pars plana vitrectomy without ICG staining and ILM peeling
15908235|NCT03586180|Behavioral|Medical Clowning for children|Clowns in clinical setting have been found to be effective in reducing children's experiences of these effects during hospitalization and before procedures.
15908236|NCT03586167|Device|LID014341 contact lenses|Investigational monthly replacement silicone hydrogel contact lenses with water gradient coating
15908237|NCT03586167|Device|Comfilcon A contact lenses|Silicone hydrogel contact lenses
15908238|NCT03586154|Combination Product|Platelet rich plasma|combined platelet rich plasma and 1 ml ketamine in a dose of o.5 ml/kg plus 5ml bupivacaine 0.5% in a total volume 10 ml
15908239|NCT03586154|Drug|ketamine and bupivacaine injection|1 ml ketamine in a dose of o.5 ml/kg plus 5ml bupivacaine 0.5% in a total volume 10 ml
15908240|NCT03586141|Diagnostic Test|Pronto® hemoglobin measurement tool|All patients who are planned to undergo elective surgery come to the preoperative anesthetic ambulance. They are all measured by the Pronto® hemoglobin measurement tool
15908241|NCT03586128|Drug|PrEP|PrEP will be introduced into clinics according to Uganda national guidelines using a stepped wedge design. Uganda guidelines recommend any tenofovir disoproxil fumarate (TDF) containing medication be used for PrEP; this includes emtricitabine (FTC)/TDF, lamivudine (3TC)/TDF or TDF alone.
15908242|NCT03586128|Drug|ART|ART medication will be provided according to Uganda national guidelines for persons living with HIV.
15908243|NCT03586115|Device|Critical flicker frequency assessment|All patients will undergo critical flicker frequency assessment to evaluate the presence of minimal hepatic encephalopaty. In addition, hepatic elastometry will be assessed to evaluate the presence of advanced liver fibrosis.
15908244|NCT03586102|Dietary Supplement|High protein supplementation|To increase protein content of human milk, a fixed amount of commercially available hydrolyzed bovine protein will be added to fortified human milk. With this pragmatic approach, preterm infants assigned to the high protein supplementation group will receive > 4.5 g/kg/day of enteral protein after establishment of full enteral feeding.
15908245|NCT03586102|Dietary Supplement|Standard protein supplementation|Infants assigned to the standard protein supplementation group will receive fortified human milk (< 4.5 g/kg/day of enteral protein)
15908246|NCT03586089|Drug|Phenobarbital Sodium|Single IV dose of phenobarbital (7.5 mg per kg of body weight prepared in 250 ml D5W)
15908247|NCT03586089|Drug|Inactive placebo|Single dose of inactive placebo prepared in 250 ml D5W).
15908248|NCT03586076|Biological|JHL1922|Single doses of JHL1922 2.5 mg and then 10 mg per eRapid nebulizer
15908249|NCT03586076|Biological|dornase alfa|Single doses of Pulmozyme® 2.5 mg and then 10 mg per eRapid nebulizer
15908250|NCT03586063|Other|Data collection|"This is a non-interventional (observational) national multicentre prospective study.
~Treatment was administered according to the Summary of Product Characteristics (SmPC): maximum 6 injections administered every 28 days.
~The decision to prescribe GnRH-a (Diphereline 3,75 mg) was made prior to and independently from the decision to enroll the patient into the study."
15908251|NCT03586050|Device|Microwave ablation|All patients will receive microwave ablation using the NeuWave Microwave Ablation System and Accessories
15908252|NCT03586037|Drug|AD-2011 10/20 mg|AD-2011 10/20 mg tablet
15908253|NCT03586037|Drug|AD-2012 80mg|AD-2012 80mg tablet
15908254|NCT03586037|Drug|AD-2011 10/20 mg + AD-2012 80mg|AD-2011 10/20 mg + AD-2012 80mg tablet
15908255|NCT03586024|Drug|Pembrolizumab|dose of pembrolizumab will be 200 mg IV every 3 weeks
15908256|NCT03586011|Behavioral|Predicting factors for increased physical activity|
15908257|NCT03585998|Drug|Durvalumab|Concurrent radiotherapy Maintenance therapy
15908258|NCT03585985|Procedure|Standard patient monitor|Measurement of reference data: heart rate, heart rate variability and respiratory rate
15908259|NCT03585985|Procedure|Photoplethysmographie-Imaging (PPGI) + Infrared thermography (IRT)|Camera-based technology for the determination of heart rate variability (PPGI) and contactless measurement of breathing rate (IRT)
15908260|NCT03585972|Behavioral|Frailty Prevention Program|4 face-to-face sessions, with a occupational therapist over 4 months to address function, safety, social participation, diet, exercise, sleep, and medication management. Sessions are expected to last between 60-120 minutes. The first session is a comprehensive occupational therapy evaluation and treatment plan. Sessions 2 and 3 involved physical activity and dietary education, counseling and goal setting. Session 4 involves reviewing program progress, and setting maintenance goals.
15908261|NCT03585959|Device|superDimension™ Navigation System Version 7.2|superDimension™ Navigation System Version 7.2 with Fluoroscopic Navigation Technology in subjects undergoing lung lesion biopsy
15908262|NCT03585946|Drug|Site specific standard of care comparison|Patients outcomes will be assessed and compared based on the medication they receive which will be assigned based on the standard of care at each enrolling site.
15908263|NCT03585933|Diagnostic Test|Cardiac magnetic resonance imaging|Echocardiography: assessment of aortic stenosis severity, evaluation of LV diastolic and systolic function; CMR: chambers quantification, LGE, T1 mapping; Intraoperative myocardial tissue biopsy for patients undergoing SAVR; DPD scintigraphy: assessment of cardiac transthyretin amyloidosis
15908264|NCT03585920|Behavioral|Expanded Corn Snack|A standard expanded snack will be used in each of the 3 arms, the content and type of fat added to the snack is varied in the two experimental arms.
15908265|NCT03585907|Dietary Supplement|MAD|A high fat, low carbohydrate diet
15908266|NCT03585907|Dietary Supplement|MIND|A combination of the Mediterranean and DASH diets
15908267|NCT03585894|Other|Sumatriptan|Receive intravenous infusion of sumatriptan
15908268|NCT03585894|Other|Ketorolac|Receive intravenous infusion of ketorolac
15908269|NCT03585881|Device|3DPrinted Windowed Bracket- Positioning tray|3 D printed tray with windows for accurate positioning of brackets
15908270|NCT03585868|Other|Placebo|Beverage with no flavonoids
15908271|NCT03585868|Other|Flavonoids|Flavonoids-enriched cacao beverage
15908272|NCT03585868|Dietary Supplement|No Flavonoids|Beverage with alkalinized cocoa which eliminates flavonoid content
15908273|NCT03585855|Other|MSC transplantation|MSC transplantation: patients with ABMR treated with MSC transplantation
15908274|NCT03585842|Other|No intervention|No intervention
15908275|NCT03585829|Drug|Hydrocortisone|at a substitutive dosage
15908276|NCT03585829|Drug|Prednisolone|at a substitutive dosage
15908277|NCT03585803|Drug|KMRC011 5μg or Placebo|Intramuscular Injection of KMRC011 5μg or Placebo(Normal Saline) 0.1ml
15908278|NCT03585803|Drug|KMRC011 10μg or Placebo|Intramuscular Injection of KMRC011 10μg or Placebo(Normal Saline) 0.2ml
15908279|NCT03585803|Drug|KMRC011 15μg or Placebo|Intramuscular Injection of KMRC011 15μg or Placebo(Normal Saline) 0.3ml
15908280|NCT03585803|Drug|KMRC011 20μg or Placebo|Intramuscular Injection of KMRC011 30μg or Placebo(Normal Saline) 0.4ml
15908281|NCT03585803|Drug|KMRC011 25μg or Placebo|Intramuscular Injection of KMRC011 45μg or Placebo(Normal Saline) 0.5ml
15908282|NCT03585790|Device|Contact lens with Multifocal Optics|This contact lens has optics to aid the accommodative and convergence systems
15908283|NCT03585790|Device|Contact lens with Single Vision Optics|This contact lens has standard single vision optics
15908284|NCT03585764|Drug|MOv19-BBz CAR T cells|intraperitoneally administered lentiviral transduced MOv19-BBz CAR T cells with or without cyclophosphamide + fludarabine as lymphodepleting chemotherapy.
15908285|NCT03585764|Device|Alpha Folate Receptor expression test|Patients will first be pre-screened for alpha folate receptor expression. The test for alpha folate receptor expression is a laboratory developed test+, developed and conducted by the Hospital of the University of Pennsylvania Pathology and Laboratory Medicine lab to determine subject eligibility. This test is not an approved FDA device and its use is investigational.
15908286|NCT03585751|Procedure|Pulpectomy for primary molars + triple antibiotic mix|complete extirpation of infected pulp from primary molars. Following instrumentation and copious irrigation ,the root canals are filled with one of .Following instrumentation and copious irrigation ,the root canals are filled with a triple antibiotic mix mixed with a Carrier ( MP) as an obturating material
15908287|NCT03585751|Procedure|Pulpectomy for primary molars + 3mixstatin|complete extirpation of infected pulp from primary molars. Following instrumentation and copious irrigation ,the root canals are filled with one of .Following instrumentation and copious irrigation ,the root canals are filled with 3mixstatin (triple antibiotic mix + simvastatin) as an obturating material mixed with a Carrier ( MP) as an obturating material
15908288|NCT03585751|Procedure|Pulpectomy for primary molars + simvastatin|complete extirpation of infected pulp from primary molars. Following instrumentation and copious irrigation ,the root canals are filled with simvastatin as mixed with a Carrier ( MP) as an obturating material
15908289|NCT03585738|Dietary Supplement|Inositol + Folic acid|"Daily oral supplementation before spontaneous conception until delivery:
~Myo-Inositol: 1100 mg D-chiro-inositol: 27.6 mg Folic acid: 400 mcg"
15908290|NCT03585738|Dietary Supplement|Folic acid|"Daily oral supplementation before spontaneous conception until delivery:
~Folic acid: 400 mcg"
15908291|NCT03585725|Drug|Ribavirin|"Ribavirin is FDA-approved oral medication for antiviral indications. Ribavirin will be obtained commercially for this trial.
~Treatment will be administered on an outpatient basis. Ribavirin should be administered with food."
15908292|NCT03585712|Drug|Norgestrel 0.075 mg|Subjects will take norgestrel 75 mcg every day at the same time for three 28-day treatment periods, except for 1 specific day during treatment period 2 and treatment period 3
15908293|NCT03585699|Diagnostic Test|Fluoroscopy Guided Spinal Biopsy|"Spinal biopsy done via Transpedicular approach with an 8-gauge T-Lok™ bone marrow biopsy needle under fluoroscopic guidance.
~Samples collected were sent to laboratories for histopathological examination (HPE), culture and sensitivity (bacteriology, mycology and acid-fast bacilli), staining (Gram and Ziehl-Neelsen) and polymerase chain reaction (PCR) test for Mycobacterium tuberculosis."
15908294|NCT03585699|Diagnostic Test|CT guided Spinal Biopsy|"Spinal biopsy done via Transpedicular approach with an 8-gauge T-Lok™ bone marrow biopsy needle under CT guidance.
~Samples collected were sent to laboratories for histopathological examination (HPE), culture and sensitivity (bacteriology, mycology and acid-fast bacilli), staining (Gram and Ziehl-Neelsen) and polymerase chain reaction (PCR) test for Mycobacterium tuberculosis."
15908295|NCT03585686|Drug|Vemurafenib|vemurafenib 20 mg/kg/day
15908296|NCT03585686|Drug|Cytarabine|100 mg/m2/12 h, days 1-5
15908297|NCT03585686|Drug|2-chlorodeoxyadenosine|6 mg/m2/d, days 1-5
15908298|NCT03585673|Drug|Docetaxel-PM|Docetaxel-PM 35mg/m2 intravenous over 1hour day1 and 8 every 3 weeks till progression
15908299|NCT03585673|Drug|Oxaliplatin|Oxaliplatin 120mg/m2 intravenous over 2 hour day 1 every 3 weeks till progression
15908300|NCT03585660|Procedure|Diagnostic MRI|Participants will be scanned using a standard clinical prostate MRI protocol.
15908301|NCT03585660|Procedure|Diagnostic Prostate Biopsy|Participants will undergo a prostate biopsy as their standard of care treatment. The provider performing biopsy will select areas to be biopsies as part of normal clinical judgment.
15908302|NCT03585660|Device|Risk Map DSS tool|The Risk Map DSS tool will select up to 2 additional areas to be biopsied based on analysis of MRI images. The clinical provider will make final decision on areas to be biopsied.
15908303|NCT03585647|Procedure|hip arthroplasty|Hip replacement is a surgery for people with severe hip damage. The most common cause of damage is osteoarthritis.
15908304|NCT03585634|Behavioral|Dads in Gear Program|
15908305|NCT03585621|Radiation|SBRT|Each radiation treatment plan will be customized to the patient and tumour in order to deliver highly conformal, conebeam CT guided SBRT radiotherapy in 4 fractions delivered over 2-4 weeks.
15908306|NCT03585608|Procedure|Neck extension|The neck extension is routine posture during palatoplasty. We will evaluate the change in optic nerve sheath diameters before and after neck extension.
15908308|NCT03585582|Other|Prospective follow-up|This is a prospective follow-up study to assess of outcomes at 1 year following the discharge from the hospitalization during which PARDS was diagnosed
15908309|NCT03585569|Biological|Abobotulinumtoxin A|Treating Patients with Multiple Sclerosis with lower extremity spasticity using Dysport (Abobotulinumtoxin A)
15908310|NCT03585556|Drug|Intravitreal anti-VEGF|Intravitreal injection of anti-VEGF at Day 0 then monthly as needed
15908311|NCT03585556|Biological|Intravitreal AAVCAGsCD59|An intravitreal injection of AAVCAGsCD59 will occur at Day 7 once
15908312|NCT03585556|Drug|Oral prednisolone|A 7 day tapering dose of oral prednisone will be taken at Day 30 by all patients
15908313|NCT03585543|Behavioral|Voice Crisis Alert V2|Intervention consists of a mHealth app delivered via smartphone
15908314|NCT03585530|Drug|raltitrexed|Raltitrexed 2.6mg/m2 was administered on d1、d22
15908315|NCT03585517|Drug|IM23|T Cells Expressing an Anti-CD123 Chimeric Antigen Receptor
15908316|NCT03585504|Drug|Etonogestrel contraceptive implant|Etonogestrel contraceptive implant
15908317|NCT03585491|Procedure|Latarjet Procedure|Participants will undergo open or arthroscopic Latarjet procedure.
15908318|NCT03585491|Procedure|Bankart + Remplissage Procedure|Participants will undergo arthroscopic stabilization.
15908319|NCT03585478|Drug|Latiglutenase|Latiglutenase administered orally (daily)
15908320|NCT03585478|Other|Placebo|Placebo administered orally (daily)
15908321|NCT03585465|Drug|Vinblastine|"Experimentals Arm A or C (First stage): 2 mg/m2/day IV, weekly per cycle, 28 days cycle
~Experimental Arms Metronomic or Metronomic+Nivolumab (second stage): see C"
15908322|NCT03585465|Drug|Cyclophosphamide|"Arm A (First stage): 30 mg/m2/day PO, D1-4// D8-11// D15-18// D22-25 per cycle, 28 days cycle
~Arm C (First stage): 30 mg/m2/day PO, D1-D4// D15-D18 per cycle, 28 days cycle
~Metronomic or Metronomic+Nivolumab Arm (second stage): see C"
15908323|NCT03585465|Drug|Capecitabine|"Arm B (First stage): 400 to 600 mg/m2/day PO, all days per cycle, 28 days cycle
~Arm C (First stage): 400 to 600 mg/m2/day PO, D8-D11// D22-D25 per cycle, 28 days cycle
~Metronomic or Metronomic+Nivolumab Arm (second stage): see C"
15908324|NCT03585465|Drug|Nivolumab|"Arm A, B or C (First stage): 3 mg/kg IV, D1 & D15 per cycle, 28 days cycle
~Metronomic+Nivolumab Arm (second stage): 3 mg/kg IV, D1 & D15 per cycle, 28 days cycle"
15908325|NCT03585452|Drug|Dexmedetomidine Infusion|Additional dexmedetomidine infusion, as an element of general anesthesia
15908326|NCT03585439|Procedure|Observational study evaluating the results of an intervention for isthmic spondylolisthesis: surgical procedure with double approach: Anterior lumbar Interbody Fusion then postero-lateral fusion|First in supine position, an ALIF is performed: with a Pfannenstiel incision, through a retroperitoneal approach, a discectomy is performed at the level of the spondylolisthesis then a cage is placed between the two vertebral bodies. Then, in prone position, a standard posterior approach is performed, pedicle screws are placed to achieve a postero-lateral fusion. A decompression may be associated.
15908327|NCT03585426|Drug|Vancomycin|Vancomycin, a novel intravenously administered glycylcycline antibiotic, currently plays a key role in the management of complicated multi-organism infections.
15908328|NCT03585413|Dietary Supplement|Micronutrient-probiotic-combination|Specific combined micronutrient-probiotic-supplement with different vitamins, minerals, phytochemicals and bioactive substances, and a mixture of 10 different probiotic bacteria.
15908329|NCT03585413|Dietary Supplement|Micronutrient-placebo-combination|micronutrient (capsule)-placebo (powder)-supplement
15908330|NCT03585400|Other|Observational Study|Observational Study: Not Applicable for Observational Studies
15908331|NCT03585387|Procedure|Navigation|Navigation of a balloon catheter using two navigation methods (1-Fluoroscopy only; 2- Fluoroscopy + CPS).
15908332|NCT03585374|Combination Product|Methoxyflurane and Penthrox inhaler|3ml of methoxyflurane vaporized through an inhaler (Penthrox). Inhalation, by regular breathing, last about 25 minutes.
15908333|NCT03585374|Drug|Morphine|Each site will use the commercial available product already in use as per local clinical practice. The drug will be intravenously administered at a dose of 0.10 mg/Kg body weight. The time of infusion should be not longer than 10 minutes.
15908334|NCT03585374|Drug|Paracetamol|Each site will use the commercial available product already in use as per local clinical practice. The drug will be intravenously administered at a 1 g dose The time of infusion should be not longer than 10 minutes.
15908335|NCT03585374|Drug|Ketoprofen|Each site will use the commercial available product already in use as per local clinical practice. The drug will be intravenously administered at a 100 mg dose. The time of infusion should be not longer than 10 minutes.
15908336|NCT03585361|Behavioral|Health centers provide PPFP counseling and services|Providers trained on PPFP counseling skills and insertion technique for placing intrauterine devices (IUDs) immediately after birth with a refresher on insertion techniques for IUDs and implants. Training also included how to use tools to document PPFP services and referrals. Follow up supervision ensured skill mastery and retention.
15908360|NCT03585179|Drug|5% topical tranexamic acid|Participants will apply a layer of gel on the affected skin bid for 12 weeks
15908784|NCT03582085|Biological|Bacillus Calmette Guerin Vaccine|Experimental
15908337|NCT03585361|Behavioral|HEWs provide PPFP counseling and services|HEWs trained in PPFP counseling with a refresher on implant insertion skills. Training also included how to use tools to document PPFP services, method choice, and pregnancy risk at every contact during pregnancy and up to 12 months after birth. Follow up supervision ensured skill improvement and retention.
15908338|NCT03585361|Behavioral|Volunteers (Development Army) promote PPFP|HEWs orient volunteers on promoting PPFP and how to use a pictoral tool to remind women to access ANC, immunization, and PPFP services and to document women's method preferences and pregnancy risk at every contact during pregnancy and up to 12 months after birth.
15908339|NCT03585361|Behavioral|Health centers conduct data reviews|Health center staff document PPFP counseling, provision, and referrals in registers and use a facility dashboard to display and track aggregate PPFP data.
15908340|NCT03585361|Behavioral|HEWs and volunteers track PPFP|HEWs and volunteers track PPFP counseling, choice of method, receipt of methods, and pregnancy risk starting in pregnancy through 12 months postpartum. HEWs and volunteers meet and review data.
15908341|NCT03585348|Other|Neuromuscular blocking agents|Neuromuscular blocking agent ED95 equivalent dose by provider
15908342|NCT03585322|Drug|APG-1387 for Injection|Multiple dose cohorts, 30 minute IV infusion, once weekly for 4 weeks .
15908343|NCT03585309|Procedure|The impact of electrocoagulation on ovarian reserve after laparoscopic excision of ovarian cysts:|"Randomization Randomization will be conducted using computer generated table. Group A (48 CASES) without coagulation
~Group A 6 89 92 35 1 15 21 16 60 49 53 91 34 5 94 64 88 58 7 33 8 75 29 56 10 23 37 19 32 71 55 84 36 77 50 2 46 70 82 9 51 54 72 18 25 31 14 63
~Group B (48 CASES) with coagulation Group B 79 38 93 43 52 44 62 47 68 76 86 95 81 83 42 80 94 30 78 61 12 17 66 13 41 59 22 73 39 65 4 90 28 26 3 87 40 85 69 48 27 24 74 57 11 20 67 45
~Allocation and concealment Nineteen six opaque envelopes will be numbered serially and in each envelope the corresponding letter which denotes the allocated group will be put according to randomization table then all envelopes will be closed and put in one box. When the first patient arrives the first envelope will be opened and the patient will be allocated according to the letter inside."
15908344|NCT03585296|Drug|ATI-502|Topical Solution
15908345|NCT03585283|Other|Myofascial Group|Manual myofascial release will be applied at prone position. Patient's upper thoracic and cervical region will be undressed. Researcher will use direct and indirect myofascial release techniques on upper thoracic and cervical region focusing on trigger point located muscles (most frequently m. trapezius)
15908346|NCT03585283|Other|Sham Group|Patient's upper thoracic and cervical region will be undressed. Researcher will place his hands on points that used for myofascial release however no pressure or release techniques will be used.
15908347|NCT03585270|Drug|Clazosentan|Clazosentan will be administered as a continuous intravenous infusion at the dose of 15 mg/hour for up to 14 days.
15908348|NCT03585270|Drug|Placebo|Placebo will be administered at the same infusion rate as clazosentan for up to 14 days.
15908349|NCT03585257|Biological|25% IV albumin|"Intravenous 25% albumin infusion 1.5 g/kg body weight (maximum 100gm) once a week for four weeks for a maximum of 5 infusions. These infusions will be administered over sixty minutes per clinical treatment protocols for this population. Patients and investigators will be blinded as to the characteristic of the infusion. Pre-infusion serum albumin will be checked and if >4.0gm/dl, then normal saline will be given instead as mentioned in the blinding section above. Samples will be collected before and one hour after the infusion for all patients.
~The total grams of albumin infused over the 4 weeks during and outside the study will be collected and compared between groups."
15908350|NCT03585257|Other|Placebo|"Normal saline infusion 1.5g/kg body weight once a week for four weeks for a maximum of 5 infusions. These infusions will be administered over sixty minutes per clinical treatment protocols for this population. Patients and investigators will be blinded as to the characteristic of the infusion. Pre-infusion serum albumin will be checked and if >4.0gm/dl, then normal saline will be given instead as mentioned in the blinding section above. Samples will be collected before and one hour after the infusion for all patients.
~The total grams of albumin infused over the 4 weeks during and outside the study will be collected and compared between groups."
15908351|NCT03585244|Other|weekly weight|weekly weight data collection for six months
15908352|NCT03585231|Behavioral|Immediate access to novel messaging program intervention|The experimental arm includes an immediate intervention using a novel messaging program for smoking cessation.
15908353|NCT03585231|Behavioral|Immediate access to standard of care messaging program intervention|The immediate control intervention uses a standard of care messaging program for smoking cessation.
15908354|NCT03585231|Behavioral|Delayed access to novel novel messaging program intervention|The delayed control intervention uses the novel messaging program for smoking cessation.
15908355|NCT03585218|Biological|Inhalation of essential oils|"Intervention Inhalation of essential oils: From the T1 (2nd Cycle CT), Experimental Group Arms will undergo the inhalation of the hedonic aroma selected by them at the time of chemotherapy (among several types of aromas). It is intended that the participant, when receiving the CT, inhales the aroma phase-in and under the investigator's observation until the end of the treatment (about two hours). The inhalation of essential oils will occur using cotton rolls impregnated with the selected oil. The control group is not subject to intervention during chemotherapy treatment."
15908356|NCT03585205|Behavioral|Stress and cognitive load Induction|"Participants will engage in demanding cognitive load computerized tasks (such as N-back and Stroop tasks). They will engage in these tasks once in a non-stressful (neutral condition), and once in a stressful condition.
~Psychological stress will be induced by the following methods:
~Limiting time for task completion
~Providing negative feedback on participants' performance in relation to others
~Presentation of sudden, loud sounds during task"
15908357|NCT03585192|Other|Skin Group|"If the newborn is vigorous (crying, good respiratory effort, good tone) after vaginal delivery, newborn will be able to go directly to Mother's chest for immediate SSC
~A pulse oximeter will be placed on the newborn's right wrist. Saturations will be monitored on a pulse oximeter located next to the Mother's bed for the first hour of life."
15908358|NCT03585192|Other|Warmer Group|"Newborn will go to the radiant warmer, pulse oximeter placed on newborn's right wrist, and saturations will be monitored on the Panda Warmer.
~If stable per Baby RN after 20 minutes of observation, the newborn will be placed on Mother's chest for SSC. Vital signs will be monitored for the first hour of life."
15908359|NCT03585179|Drug|Oral Tranexamic Acid|Participants will take a pill of 250 mg bid for 12 weeks
15908361|NCT03585179|Drug|4% hydroquinone|Participants will apply a layer of cream on the affected skin once at night
15908362|NCT03585166|Procedure|lpaparoscopic hepatectomy|laparoscopic hepatectomy： laparoscopic hepatectomy for hepatocellular carcinoma.
15908363|NCT03585166|Procedure|open hepatectomy|open hepatectomy: open hepatectomy for hepatocellular carcinoma
15908364|NCT03585153|Other|Non-contrast magnetic resonance imaging|subjects lie in an MRI machine (non-contrast) for 30 minutes while we take pictures of their pancreas
15908365|NCT03585140|Other|Normal diet|The energy consumption of each of the participants will be calculated, using the Mifflin-St Jeor formula. Each participant will receive a standard menu of 6 days according to their metabolic requirements and a list of equivalent foods. The distribution of macronutrients will be: 45% carbohydrates, 30% lipids and 25% proteins.
15908366|NCT03585140|Other|Low glycemic diet|The energy consumption of each of the participants will be calculated, using the Mifflin-St Jeor formula. Each participant will receive a standard menu of 6 days according to their metabolic requirements and a list of equivalent foods. A list of foods classified as having low index and glycemic load was used according to the mexican equivalent food system. The distribution of macronutrients will be: 45% carbohydrates, 30% lipids and 25% proteins. Milk and vitamin supplements will be eliminated from the diet.
15908367|NCT03585140|Drug|Adapalene 0.1% Gel|Adapalene 0.1% gel daily at night for 12 weeks, applied on the face, chest and back.
15908368|NCT03585140|Drug|Doxycycline|Doxycycline 100 mg per day orally, before breakfast
15908369|NCT03585127|Behavioral|Cognitive Behavioral Therapy|Participants will be offered 9 individual and weekly sessions of 1 hour, which will be administered in an individual format by a licensed psychologist or psychiatrist trained in Cognitive Behavioral Therapy for psychosis (CBTp). The program is derived and adapted from current evidence-based treatments for hallucinations. The 9 CBTp sessions will consist of a succession of learning modules and suggested task assignments.
15908370|NCT03585127|Behavioral|Avatar Therapy|Participants will be offered 9 individual and weekly sessions of 1 hour, which will be administered in an individual format by a licensed psychologist or psychiatrist experienced with psychosis patients. The therapy will consist in prompting participants to enter in a dialogue with their persecutor to better regulate their emotional responses. Over the course of the therapy, the avatar's speech and tone will gradually be changed by the therapist to echo participants' improved ability to regulate their emotions. That is, the avatar will progressively change from being abusive to becoming helpful and supportive. By doing so, the therapy will seek to reinforce participants' feeling of empowerment over their voices.
15908371|NCT03585114|Drug|[F-18] DCFPyL|[18F]DCFPyL will be used for study imaging. It will be administered intravenously on the day of imaging. Subjects will receive a bolus injection of 9mCi (331 MBq) of [18F]DCFPyL through a peripheral IV catheter. 60 to 120 minutes after injection, a whole body (toes to vertex) lowdose CT will be obtained (120 kVp, 80 mA maximum).
15908372|NCT03585114|Procedure|PET/CT imaging|As per standard of care, acquisition will be performed on PET/CT scanner (Siemens, Germany) operating in 3D emission mode with CT-derived attenuation correction.
15908373|NCT03585101|Drug|Elbasvir/grazoprevir|Daily fixed-dose combination (FDC) elbasvir (EBR) (50 mg)/grazoprevir (GZR) (100 mg) for 12 weeks
15908374|NCT03585088|Device|surgical pleth index|All patients applied surgical pleth index after recovery of spontaneous breathing at the time of peritoneum and skin closure under Bispectral index score <=60.
15908375|NCT03585062|Drug|S1,|S-1 is a combination of tegafur, gimeracil and oteracil at a molar ratio of 1:0.4:1, and is a new oral fluoropyrimidine anticancer agent shown to be effective for pancreatic cancer. cancer
15908376|NCT03585062|Drug|Paclitaxel-albumin|Paclitaxel-albumin is a drug which showed a survival benefit in Pancreatic Cancer when combined with S1
15908377|NCT03585049|Other|Vaginal swabs|The protocol includes the secondary use of vaginal swabs that are primarily used for routine diagnostic assessment in a vulvovaginal clinic
15908378|NCT03585036|Drug|dexketoprofen|"Drug: dexketoprofen Women will receive oral dexketoprofen 25mg 2 hours before the procedure
~Drug: Placebo 1 Women will receive an oral placebo similar to Tramadol 2 hours before the procedure."
15908379|NCT03585036|Drug|Tramadol|"Drug: Tramadol Women will receive oral Tramadol 100 mg 2 hours before the procedure
~Drug: Placebo 2 Women will receive an oral placebo similar to dexketoprofen 2 hours before the procedure"
15908380|NCT03585036|Drug|Placebo|"Drug: Placebo 1 Women will receive an oral placebo similar to Tramadol 2 hours before the procedure.
~Drug: Placebo 2 Women will receive an oral placebo similar to dexketoprofen 2 hours before the procedure"
15908381|NCT03585023|Diagnostic Test|Spontaneous miscarriage|Viral DNA and RNA analysis of HPyV and HPV, BKV and JCV. Bacterial DNA and RNA analysis of Chlamydia trachomatis, Ureaplasma parvum, U. urealyticum, Mycoplasma hominis.
15908382|NCT03585023|Diagnostic Test|Voluntary pregnancy interruption|Viral DNA and RNA analysis of HPyV and HPV, BKV and JCV. Bacterial DNA and RNA analysis of Chlamydia trachomatis, Ureaplasma parvum, U. urealyticum, Mycoplasma hominis.
15908383|NCT03585010|Behavioral|Supportive Parenting for Anxious Childhood Emotions|12 sessions with parents
15908384|NCT03585010|Behavioral|Parent Educational Support|12 sessions with parents
15908385|NCT03585010|Behavioral|Cognitive-Behavioral Therapy|12 sessions with child
15908386|NCT03584997|Procedure|ABB And Autogenous Particulate|Mixing the autogenous bone graft aquired at the time of surgery with a 50:50 ration of anorganic bovine bone and filling the socket
15908387|NCT03584997|Procedure|PRF, ABB & Autogenous Particulate|adding an injectable platelets rich fibrin to a Mixture of autogenous bone graft aquired at the time of surgery with a 50:50 ration of anorganic bovine bone and filling the socket
15908388|NCT03584984|Procedure|Mixture of Autogenous bone & Anorganic Bovine Bone (ABB)|Filling the socket with Mixing of autogenous bone graft and anorganic bovine bone in a 50:50 ratio
15908389|NCT03584984|Procedure|Anorganic Bovine Bone (ABB)|Filling the socket with Anorganic bovine bone graft material only
15908390|NCT03584984|Procedure|Absorbable gelatin sponge|Filling the socket with an absorbable gelatin sponge foam pack
15908417|NCT03584763|Diagnostic Test|Umbilical artery Doppler|Umbilical artery Doppler ultrasound will be performed by most expert sonographer in umbilical artery Doppler at the special care unit, using a 3.5MHz transabdominal probe of SAMSUNG MEDISON, SONOACE R5 ultrasound machine, using the standard protocol of the unit for minimizing the interobserver variations.
15908418|NCT03584750|Other|Floating|Floating in specialized tank with full floatation and sensory deprivation.
15908391|NCT03584945|Behavioral|Cognitive Behavioral Therapy|The treatment team will offer a course of cognitive behavioral therapy (CBT) (45 minute sessions for 12 to 16 weeks), augmented by medication treatment when clinically indicated based on the clinical treatment standards. Cognitive-behavioral therapy (CBT) is a treatment based on learning and cognitive theories. CBT for Obsessive-Compulsive Disorder (OCD) involves gradually exposing patients to anxiety provoking stimuli while having patients refrain from engaging in compulsive rituals and/or avoidance behaviors. There are three major components of CBT treatment for OCD, specifically: (1) exposure to anxiety provoking stimuli, (2) response prevention, and (3) cognitive techniques intended to decrease anxiety during the exposure and response prevention processes.
15908392|NCT03584945|Other|Community Referral as appropriate|Participants with Obsessive Compulsive Symptoms will be referred to the community for treatment
15908393|NCT03584932|Behavioral|LINK2 Youth Services Navigation Intervention|There will be 6 in-person sessions delivered by a youth services navigator, plus weekly check-in calls after session 2 for a total of six months. As part of the learning sessions, the participant will learn important information about HIV and how to get the most out of his/her HIV care.
15908394|NCT03584919|Drug|doxycycline|patients received oral doxycycline 100 milgrams bid for 15 days
15908395|NCT03584919|Drug|Cefuroxime Axetil 500Mg Tab|patients received cefuroxime axetil 500 milgrams bid for 15 days
15908396|NCT03584919|Other|control subjects|no intervention
15908397|NCT03584906|Procedure|DGG Harvesting approach|An epithelialized graft is harvested from the superficial palate and then extraorally de-epithelialized in order to obtain a connective tissue graft
15908398|NCT03584906|Procedure|ET harvesting approach|A connective tissue graft is harvested from the palate after reflecting a primary palatal flap
15908399|NCT03584906|Procedure|TDT harvesting approach|A connective tissue graft is harvested from the palate after reflecting a primary palatal flap
15908400|NCT03584906|Procedure|MT harvesting approach|An epithelialized graft is harvested from the maxillary tuberosity and then extraorally de-epithelialized in order to obtain a connective tissue graft
15908401|NCT03584906|Procedure|Root coverage procedure|A single or multiple gingival recession is treated with a coronally advanced flap and a connective tissue graft
15908402|NCT03584893|Procedure|Blood sampling for Cholestanol Analysis|Cholestanol analysis will be performed to see the Rate of juvenile cataract patients whose cholestanol test result is above threshold (3.75 mg/mL) and suspected CTX cases
15908403|NCT03584880|Device|Diode laser disinfection|Root canal disinfection using a 940 nm dental laser after the removal of root canal filling of failed endodontic cases.
15908404|NCT03584880|Device|Pseudo diode laser disinfection|Without activating laser energy, same procedure as experimental group was performed (Sham laser application)
15908405|NCT03584867|Other|refresher training at six months|a 5 cycles of 30:2 compression to ventilation ratio will be offered to experimental group at six months from BLS certification.
15908406|NCT03584854|Drug|15-methyl prostaglandin F2α|"Participants will receive standard intraoperative care including an infusion of oxytocin immediately postpartum. If a second-line uterotonic is requested, patients randomized to the carboprost study group will receive an intramuscular dose of 0.25mg (1mL) carboprost. If another second-line uterotonic is requested, the patients will receive 0.2mg (1mL) intramuscular methylergonovine."
15908407|NCT03584854|Drug|Methylergonovine Maleate|"Participants will receive standard intraoperative care including an infusion of oxytocin immediately postpartum. If a second-line uterotonic is requested, patients randomized to the methergine study group will receive an intramuscular dose of 0.2mg (1mL) methylergonovine. If another second-line uterotonic is requested, the patients will receive 0.25mg (1mL) intramuscular carboprost."
15908408|NCT03584841|Diagnostic Test|Iontophoresis sessions in forearm of subjects with pilocarpine|The test with two iontophoresis sessions is performed in a forearm of subjects. Pilocarpine is applied during the first iontophoresis session to evoke cholinergic-induced sweat secretion. Atropine, isoprenaline and aminophylline are applied during the second iontophoresis session, to block the cholinergic component and to evoke β-adrenergic-induced sweat secretion.
15908409|NCT03584828|Behavioral|Tele Cardiac Rehabilitation|"A multidisciplinary intervention that aims to optimize structured exercise performed in the community as prescribed by rehabilitation cardiologist, cardiac care nurse, and exercise physiologist.
~Additionally, in the intervention arm, we will provide psychological support, dietary intervention and disease management services that complement the structured physical activity - all by innovative smartphone applications and smart wearable devices, thus complementing the comprehensive secondary prevention program."
15908410|NCT03584815|Procedure|Surgery/Fasciotomy|Open fasciotomy of the anterior and lateral compartment + standard post-operative physiotherapy for 12 weeks
15908411|NCT03584815|Other|Physiotherapy|Intensive physiotherapy for 12 weeks including a change to forefoot/midfoot strike during running
15908412|NCT03584802|Other|Therapeutic plasma exchanges|The patient will initially receive Methylprednisolone bolus of 1g i.v. day 1, then 20 mg/day (or oral prednisone equivalent) for 21 days; and then he will have nine therapeutic plasma exchanges of 1.5x the estimated plasma volumes using albumin:saline (3:1) or fresh frozen plasma in case of an INR superior to 1.5, on days 1,2,3,5,7,9,11,13,15; followed by administration of low dose of intravenous immunoglobulin (100 mg/kg). On days 7 and 15, the patient will receive rituximab 1 g i.v. on days 7 and 15 (after therapeutic plasma exchange and premedication); and intravenous immunoglobulin 0.5 g/kg/d on days 16 to 19.
15908413|NCT03584802|Other|Conventional treatment of AE-IPF|Conventional treatment of AE-IPF
15908414|NCT03584789|Other|Clinical Decision Support|A clinical decision support system designed to assist dentists in providing optimal pain management for patients without resorting to opioids when a non-opioid alternative would suffice. It provides pertinent clinical information to the dentist, including point-of-care access to the Prescription Drug Monitoring Program.
15908415|NCT03584789|Other|Patient education|Patient education regarding pain management before and after dental extraction, including information about the risks and benefits of various strategies.
15908416|NCT03584776|Device|Virtual Reality|Participants randomized to the VR condition will experience an an immersive guided relaxation VR experience during research visits in the post-operative period. They will also have the opportunity to choose additional VR games and relaxation experiences during their inpatient stay.
15908419|NCT03584750|Other|Placebo floating|Floating in specialized tank with reduced floatation and sensory deprivation.
15908785|NCT03582085|Biological|Saline Injection|Placebo
15908420|NCT03584737|Diagnostic Test|rapid in vitro diagnostic test|IVD for qualitative detection of 3 bacterial pathogens (Haemophilus influenzae, Moraxella catarrhalis, and Streptococcus pneumoniae)
15908421|NCT03584737|Diagnostic Test|bacterial culture|Quantitative bacterial culture assay with isolate identification by MALDI-TOF.
15908422|NCT03584737|Diagnostic Test|PCR assay|Qualitative real-time PCR assay
15908423|NCT03584724|Drug|Norflo Oro|Norflo Oro is highly bioavailable curcumin complexed into phytosomes
15908424|NCT03584724|Drug|Placebo for Norflo Oro|Placebo consist of look-alike single foil pouches without active ingredient of Norflo.
15908425|NCT03584711|Combination Product|FOLFOX + panitumumab|"FOLFOX + panitumumab according to a stop and go strategy with a reintroduction loop after progression on fluoropyrimidine as maintenance treatment"
15908426|NCT03584698|Drug|Misoprostol 100Mcg Tab|women will receive misoprostol 100 mcg (Misotac, Sigma Pharmaceuticals, Egypt) vaginally applied every 6 hours till cervical dilatation.
15908427|NCT03584698|Drug|Evening Primrose Oil 1000 MG|women will receive 4 capsules evening primrose oil 1000 mg (Primrose plus, Ema Pharm, Egypt) vaginally applied every 6 hours till cervical dilatation.
15908428|NCT03584685|Device|Mask|All participants will initially be treated without the mask. In the next appointment, half will be treated with the mask.
15908429|NCT03584685|Procedure|Routine wound treatment|All participants will initially be treated for their wounds without the mask. In the next appointment, half will again be treated for their wounds without the mask.
15908430|NCT03584672|Other|Static Balance Test|Balance control is assessed by the Static Balance Test.
15908431|NCT03584672|Other|Berg Balance Scale|Functional balance is assessed by the Berg Balance Scale.
15908432|NCT03584672|Other|Timed Up an Go Test|Functional mobility is assessed by the Timed Up and Go test.
15908433|NCT03584672|Other|Four Square Step Test|Dynamic balance is assessed by the Four Square Step Test.
15908434|NCT03584672|Other|Functional Reach Test|Limits of stability is assessed by the Functional Reach Test.
15908435|NCT03584672|Other|One-leg Stance Test|Postural steadiness is assessed by the One-leg Stance Test.
15908436|NCT03584659|Device|Electronic patient-reported outcomes|Weekly reporting of patient-reported outcomes for closer contact between patient and clinic between treatment cycles.
15908437|NCT03584646|Device|Nokia GO Wearable StepTracker|All participants will be provided with a Nokia GO step tracker to monitor daily step counts. The device is not subject to FDA regulation.
15908438|NCT03584646|Other|Medication Reminder|Medication reminders are sent to participants in Arm 2 on a daily basis.
15908439|NCT03584646|Other|Weekly Check-in appointment with study team or provider|Virtual meeting or telephone call between participants and study team to assess study involvement, adherence to procedures, and following of medical care recommendations.
15908440|NCT03584633|Drug|Indocyanine Green|The subjects will be exercising on a Nu-Step exercise machine that will exercise their arms and legs simultaneously for five-minute intervals. Every five minutes their limbs will be imaged with an ICG lymphography device to determine the plateau rate of indocyanine green dye after exercise.
15908441|NCT03584620|Other|Inspiratory muscle training|Inspiratory Muscle Training was performed with an exercise tool (Powerbreath®) with a resistance range of 0-90. The training intensity was started with 30% of the Maximum Inspiratory Pressure (MIP) value obtained as a result of the mouth pressure measurement, training was progressively increased from 30% to 60% considering that they were terminal-stage pulmonary disease patients. Patients were asked to perform IMT for 15 minutes, twice a day, 7 days a week, for 3 months.
15908442|NCT03584620|Other|Pulmonary rehabilitation|"Aerobic training:The aerobic exercise program consists of treadmill walking, cycle ergometer and arm ergometer training. Group exercises were performed in sets of 15 minutes each with three exercise modalities.
~Strength training:It is recommended that resistance targets are set at loads equivalent to 20 to 40% of a 1-repetition maximum (1RM) maneuver and performed between 8 to 12 repetitions for 1 to 2 sets per session.
~Home exercise programme:The program included breathing exercises (local expansion exercises, diaphragmatic breathing and pursed lip breathing), free walking, upper and lower extremity strengthening exercises with Thera-Band"
15908443|NCT03584594|Diagnostic Test|Presepsin measurement|Presepsin measurements are performed with PathFast immunoassay analytical system on the ICU, bedside method. (Mitsubishi Chemical, Japan).
15908444|NCT03584581|Dietary Supplement|Olive polyphenols|The amount of polyphenols to be supplied is within the ranges of absolute biosecurity food described by different authors and used in different studies.
15908445|NCT03584581|Dietary Supplement|Control|Placebo
15908446|NCT03584568|Behavioral|Perspective Taking Reappraisal|Interventions involving 1) appreciating relational insights; 2) enhancing self-awareness; 3) empathetic understanding of care-recipient; 4) integrating self-care and caring for others and 5) negotiation.
15908447|NCT03584568|Other|Basic Skill Building|These skill-building exercises are commonly used in psycho-education programs for caregivers:monitoring mood and activities, relaxation techniques and scheduling pleasant events, basic communication with the care recipient, communicating the caregivers' own needs with other family member or related persons including helpers and professional staff.
15908448|NCT03584555|Procedure|SMILE using 120μm cap thickness|The surgery was performed with standardized techniques with triple centration technique using the 500-KHz VisuMax system (Carl Zeiss Meditec AG, Jena, Germany). The superior cap depth was set as 120 or 140 µm, and the length of the side cut was set to 2 mm. Once the anterior (upper) and posterior (lower) planes of the lenticule were defined, the anterior and posterior interfaces were dissected using a micropetala with a blunt circular tip and extracted with midforceps. The integrity of the lenticule was assessed subsequently.
15908449|NCT03584555|Procedure|SMILE using 140μm cap thickness|The surgery was performed with standardized techniques with triple centration technique using the 500-KHz VisuMax system (Carl Zeiss Meditec AG, Jena, Germany). The superior cap depth was set as 120 or 140 µm, and the length of the side cut was set to 2 mm. Once the anterior (upper) and posterior (lower) planes of the lenticule were defined, the anterior and posterior interfaces were dissected using a micropetala with a blunt circular tip and extracted with midforceps. The integrity of the lenticule was assessed subsequently.
15908450|NCT03584542|Other|No interventional study|No Interventional study - Only one questionnaire will be done for patients and for general practitioners
15908451|NCT03584529|Drug|Vitamin D 3|Non-Vitamin D3 Drops group Patients in this group would take nothing.
15908452|NCT03584516|Drug|Itacitinib|In Part 1dose determination participants will receive itacitinib administered orally once daily at the protocol-defined dose according to cohort enrollment. In Part 1 expansion, participants will receive either itacitinib administered orally either once daily or twice a day or corticosteroid alone based on the assigned treatment regimen according to cohort enrollment. In Part 2, participants will receive the recommended dose from Part 1 expansion.
15908453|NCT03584516|Drug|Placebo|In Part 2, participants will receive matching placebo.
15908454|NCT03584516|Drug|Methylprednisolone|Administered in Parts 1 and 2 as background reference therapy at a dose level that is commensurate with institutional guidelines based on organ involvement and severity of disease.
15908455|NCT03584516|Drug|Prednisone|Administered in Parts 1 and 2 as background reference therapy at a dose level that is commensurate with institutional guidelines based on organ involvement and severity of disease.
15908456|NCT03584503|Other|Suction Above Cuff Endotracheal Tube|Suction Above Cuff Endotracheal Tube (SACETT) has a dorsal port above the cuff designed to allow continuous or intermittent suctioning of secretions from the subglottic space
15908457|NCT03584490|Other|Computerized Talking Touchscreen|"The intervention is a computerized talking touchscreen designed to aid people with low health literacy.
~All Participants in both arms will complete a battery of health questionnaires. One group will complete questionnaires in traditional pen-and-paper format. The other group will receive the computerized talking touchscreen, which reads questions to participants on demand."
15908458|NCT03584490|Other|Phone Administration of Questionnaires|This intervention will pilot questionnaire administration over the phone with currently enrolled or previously enrolled participants from the original intervention.
15908459|NCT03584477|Device|Robot InMotion 2.0|Repetitive work of large numbers of targeted alternative movements with or without assistance. The passage between with and without assistance taking place according to the evolution of performance judged by the investigator therapist. Note that the duration of the training using the assisted mode should be at least 3 weeks, i.e. half of the total duration of treatment.
15908460|NCT03584477|Other|Conventional rehabilitation|Conventional rehabilitation implemented by an occupational therapist, involving stretching movements in submaximal passive amplitude, inhibition postures (Bobath), active efforts assisted of varied difficulty, exercises of direction of the arm towards a target with or without elbow support and grasping tasks, adapted to the capacities of the paretic upper limb.
15908461|NCT03584464|Device|Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System|Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
15908462|NCT03584451|Behavioral|rehabilitation sport|rehabilitation Sport over 52 weeks after THA, start 6 weeks postoperatively
15908463|NCT03584438|Device|Real iTBS|This will be delivered with the Magventure Magpro system; pulses are delivered with the active coil (double blinded using the Universal Serial Bus key)
15908464|NCT03584438|Device|Sham iTBS|This will be delivered with the Magventure Magpro system; pulses are delivered with the sham coil (double blinded using the Universal Serial Bus key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.
15908465|NCT03584425|Diagnostic Test|Rasch modified version of the Fugl-Meyer Motor assessment|All participants will receive a comprehensive clinical assessment of motor function including the Rasch modified version of the Fugl-Meyer Motor assessment and a kinematic assessment of unimanual and bimanual movements using a 45 sensor 3D active marker based motion capture system. The three primary measures investigated in the kinematics include: 1) movement efficiency, 2) movement smoothness, and 3) motor compensation.
15908466|NCT03584425|Diagnostic Test|Anatomical image acquisition|High-resolution structural scans will be obtained using an inversion recovery 3D spoiled gradient echo (3DSPGR) sequence using a matrix size of 256 x 256, field of view of 24 cm, section thickness of 1.5 mm with no gap between sections, and 128 slices, giving an in-plane resolution of 0.94 mm. This sequence will be used for anatomic overlays of the functional data and for spatial normalization to a standard atlas.
15908467|NCT03584425|Diagnostic Test|Functional MRI task and acquisition|Briefly, patients will be given two pressure-sensitive bulbs (one to be held in each hand and fastened lightly to their wrists with Velcro such that they do not drop it during the scan. During two 2½ minute runs they will be prompted to squeeze the bulb in either their affected or unaffected hand in blocks of 15 seconds. These blocks will be interspersed with blocks of rest. The pressure from the bulbs will be digitally recorded and quantified offline in order to: 1) verify that the patient was squeezing the ball, and 2) assess the presence of 'mirror movements' from the opposing hand that may inform the imaging results regarding loss of laterality).
15908468|NCT03584412|Behavioral|ACT OPEN|Participants will access the ACT OPEN treatment through a secure online platform. Each session consists of brief videos and audio recordings that provide information about pain and guide participants through experiential exercises (e.g., mindfulness, values clarification, goal-setting). Participants will respond to questions assessing their experiences during the session and their progress using online messaging and/or brief telephone calls according to their preference. Therapists will provide individualised feedback. ACT OPEN consists of 12 sessions over 6 weeks. Participants will be given two further weeks to finish any uncompleted sessions, or to complete additional sessions (up to four) as agreed with their therapist.
15908469|NCT03584412|Other|Waiting list control|Participants will receive their usual treatment for 5 months, after which they will complete ACT OPEN as described. A waiting list control was chosen as there is no clearly credible active psychotherapy to serve as the comparator in this context, particularly in light of high drop-out rates in two previous studies of CBT for pain in HIV. Providing the online treatment without therapist support may appear to be a logical comparison group instead of a waitlist control. However, there is evidence that therapist support is a key component of online CBT and, therefore, without this support it may not represent a credible treatment against which to judge the full treatment. In the context of the feasibility aims of this trial these reasons, the use of a waiting list control is thus justified.
15908470|NCT03584399|Other|PICS in critically ill pediatric population|Collection of additional blood sample from those subjects meeting criteria for the study.
15908471|NCT03584386|Device|V-CAMS (aka Jaspr)|V-CAMS is an integrated software system for use on any device by suicidal patients.
15908472|NCT03584373|Drug|Ketorolac Oral Tablet [Toradol]|Ketorolac is a prescribed NSAID with strong analgesic activity. Ketorolac will be administered post surgery to compare pain outcomes to that of Percocet.
15908473|NCT03584373|Drug|Acetaminophen|Acetaminophen is an over-the counter pain medication that will be administered post surgery to compare pain outcomes to that of Percocet.
15908474|NCT03584373|Drug|Oxycodone Acetaminophen|Percocet is a prescribed opioid medication to manage pain. Percocet will be administered post surgery to compare pain outcomes to that of non-opioid analgesia.
15908475|NCT03584360|Drug|Betamethasone-Calcipotriene Topical|Comparison between betamethasone-calcipotriol and placebo
15908476|NCT03584360|Drug|Betamethasone-Calcipotriene Topical|Comparison between betamethasone-calcipotriol and betamethasone
15908477|NCT03584360|Drug|Betamethasone-Calcipotriene Topical|Comparison between betamethasone-calcipotriol and propionate de clobetasol
15908478|NCT03584347|Behavioral|Injection of filler material|Subjects will be blind folded and asked to deposit 0.2cc's of each of the four investigational products, in a randomized order. First, over a weight and then into a porcine membrane.
15908479|NCT03584334|Radiation|18FDG PET|Diagnostic performance of 18FDG PET for identification of early tumor escape to immunotherapy in patients with unresectable melanoma or Broncho-Pulmonary Carcinoma No to Advanced or Metastatic Small Cells
15908480|NCT03584308|Dietary Supplement|Viusid®|The VIUSID nutritional supplement is presented in the form of envelopes and will be administered orally diluted in water, juice or milk, according to the patient's preference and will be administered 3 times a day, 15 minutes before breakfast, lunch and dinner.
15908481|NCT03584308|Dietary Supplement|Glizigen®|The GLIZIGEN® product is presented in spray bottles and will be administered orally to swallow, away from meals 2 times a day.
15908482|NCT03584308|Dietary Supplement|Viusid Placebo|The placebo of VIUSID nutritional supplement is presented in the form of envelopes and will be administered orally diluted in water, juice or milk, according to the patient's preference and will be administered 3 times a day, 15 minutes before breakfast, lunch and dinner .
15908483|NCT03584308|Dietary Supplement|Glizigen Placebo|The placebo of GLIZIGEN® product is presented in spray bottles and will be administered orally to swallow, away from meals 2 times a day.
15908484|NCT03584295|Device|Extracorporeal carbon dioxide removal|Patients with acute exacerbation of severe COPD, requiring invasive mechanical ventilation will be treated with vv-ECCO2R to facilitate early extubation
15908485|NCT03584295|Other|Conventional Care|Patient with acute exacerbation of severe COPD, requiring invasive mechanical ventilation treated with Conventional Care. Conventional care includes invasive mechanical ventilation and the attempt to extubate the patient and switch to NIV. If extubation fails tracheostomy can be performed according to the treating physician.
15908486|NCT03584282|Behavioral|Text Messaging|The text messaging intervention will send three text messages per day from a library. One will be a reminder to take PrEP, one will include PrEP information, and the third will have the content of the participant's choosing from categories of harm reduction messages and health information. Participants will also select the time period to receive these texts.
15908487|NCT03584282|Behavioral|Peer Navigation|The peer navigation intervention will provide support from a peer that is responsive to a participant's individualized needs. Peer support may include phone call reminders, help refilling PrEP prescriptions, transit assistance, or other referrals.
15908488|NCT03584269|Device|NIV Device + LTOT|Respiratory assistance by a facial mask without intubation or tracheotomy
15908489|NCT03584269|Device|LTOT|Long term oxygenatory tyherapy without NIV
15908490|NCT03584243|Procedure|A crosslinking with oxygen treatment|"A supplemental oxygen system during the cross linking will be used to apply filtered, humidified oxygen across the surface of the eye through a mask. The oxygen flow will be turned on immediately prior to initiation of irradiation, and will continue through the irradiation period. The supplemental oxygen flow will be shut off following completion of the programmed irradiation time.
~All subjects will be evaluated at screening, day 3, and 1, 3, 6, 12 and 24 months after treatment. At the same time all the potential adverse effects will be relieved."
15908491|NCT03584230|Behavioral|Assigned to positive group|See arm description
15908492|NCT03584230|Behavioral|Assigned to negative group|See arm description
15908493|NCT03584217|Drug|Aminohippurate Sodium Inj 20%|Diagnostic aid/agent used to measure effective renal plasma flow (ERPF)
15908494|NCT03584217|Drug|Iohexol Inj 300 MG/ML|Diagnostic aid/agent used to measure glomerular filtration rate (GFR)
15908495|NCT03584217|Procedure|Renal Biopsy|Minimally invasive outpatient procedure in interventional radiology to obtain renal tissue cores.
15908496|NCT03584204|Diagnostic Test|imaging|computed tomography, magnetic resosnance imaging, ultrasound
15908497|NCT03584191|Other|No treatment given|Completion of a survey
15908498|NCT03584178|Device|Budesonide via MAD device|Delivery through Mucosal Atomization Device
15908499|NCT03584178|Device|Budesonide via intranasals Saline Irrigation|delivery via nasal irrigation bottle
15908500|NCT03584165|Genetic|BIIB111|Administered as specified in the treatment arm.
15908501|NCT03584165|Genetic|BIIB112|Administered as specified in the treatment arm.
15908502|NCT03584152|Drug|Norco 5Mg-325Mg Tablet|Opioid Analgesics
15908503|NCT03584152|Drug|Tylenol 325Mg Caplet|Non opioid analgesics
15908504|NCT03584152|Drug|Ibuprofen 200 mg|Non opioid analgesics
15908505|NCT03584139|Device|IRIS HOOK|iris hook assisted maneuver in phacoemulsification
15908506|NCT03584139|Device|TRADITION|traditional phacoemulsification or phacoemulsification with 25-gauge vitreous irrigation
15908507|NCT03584126|Diagnostic Test|Electrocardiography, ecocardiography and MRI.|AF patients and healthy adult volunteers will be examined by the study physicians and included in the study according to the inclusion criteria. After a general examination, an electrocardiography, an ecocardiography and an MRI will be performed on the AF-affected and healthy hearts, respectively.
15908508|NCT03584113|Other|Video assisted thorascopic decortication|Video assisted thorascopic decortication surgery as primary intervention for empyema
15908509|NCT03584113|Other|Interventional radiology guided chest tube insertion with MIST2 trial fibrinolytics|Image guided chest tube insertion by IVR with intrapleural fibrinolytics (six doses of dornase [5mg] and alteplase [10mg] Q12hours).
15908510|NCT03584100|Device|Tourniquet 8000|Pneumatic tourniquet with appropriate upper extremity cuff, pressure sensing, and ability to set device at 40 mmHg of pressure
15908511|NCT03584087|Drug|Normal Saline|TG 0 (0Hr)
15908512|NCT03584087|Drug|Terlipressin|Duration of Terlipressin after EVL
15908515|NCT03584061|Procedure|Fat grafting|The area of dermal pain is identified and marked prior to surgery. The surgery starts with liposuction, either on the abdomen or the thigh. The harvested fat is prepared for fat grafting by sedimenting it for 10 minutes. The fat is then injected into the painful area, marked pre-surgery.
15908516|NCT03584048|Other|Alert to provider|Providers receive alerts of sub-optimal patient attendance using 4 rules.
15908517|NCT03584035|Behavioral|sensory motor integration exercises|Sensorimotor integration exercises will be given in study group. The exercises will be performed in standing, sitting and walking. Exercises will be progressively increased from eye open to closed , floor to mat and head turns to right & left under the supervision of physiotherapist. Sensorimotor integration exercises will take 45 minutes in each session.
15908518|NCT03584035|Behavioral|conventional physiotherapy|Conventional physiotherapy will take 30 minutes in each session, taking three sessions per weeks for six weeks. The exercises include simple lower extremity exercise and ambulatory training such as sit to stand, stepping, lateral and backward walking, and tandom walking etc.
15908519|NCT03584022|Device|Biopsy + Nerve Repair|During the standard sural nerve biopsy procedure, a single-use, biodegradable implant designed to repair damaged peripheral nerves will be used to repair the nerve. The MCNS1 is a hollow nerve tube made of poly(caprolactone-fumarate) (PCLF), to connect severed nerve ends and promote the growth of regenerating axons.
15908520|NCT03584022|Procedure|Biopsy Only|Standard sural nerve biopsy only, without nerve repair.
15908521|NCT03584009|Drug|Venetoclax|Venetoclax was administered orally, 800-mg tablet beginning on Cycle 1 Day 1 until the 9th October 2020.
15908522|NCT03584009|Drug|Fulvestrant|Fulvestrant was administered orally, 500 mg administered as two 250-mg intramuscular (IM) injections on Cycle 1 Days 1 and 15 and on Day 1 of each subsequent 28-day cycle
15908523|NCT03583996|Combination Product|HepQuant SHUNT Liver Diagnostic Test|One time testing using the HepQuant SHUNT Liver Diagnostic Test kit (the combination product) in subjects with CLD and undergoing a standard of care EGD. The SHUNT test will be completed prior to the EGD. Each subject will receive an IV push dose of 13C Cholate mixed with Albumin simultaneously with an oral dose of d4 Cholate
15908524|NCT03583983|Behavioral|Personalized Health Recommendations|Includes 3-month gym membership, personalized exercise and meal plans, and genetic information related to health and wellness traits. The genetic information provided to study participants will consist of scores ranging from 0 to 100 based on the population percentile of the combined effects of many genetic variants, herein referred to as polygenic scores (PGS). PGS for approximately twenty traits related to health, fitness and nutrition will be provided to study participants. These traits are chosen for their relevance to healthy lifestyle habits (e.g. genetic predisposition to adiposity or muscle strength), entertainment value (e.g. preference for mornings) or both (e.g. bitterness taste perception, which while entertaining can also help guide vegetable choices).
15908525|NCT03583983|Behavioral|Generic Health Recommendations|Includes 3-month gym membership and generic recommendations (Canada Food Guide / Health Canada Physical Activity guidelines)
15908526|NCT03583970|Device|Left Ventricular Assist Device Implantation|Veno-arterial extracorporeal membrane oxygenation prior to left ventricular assist device implantation : initial patients characteristics and 6 Month Follow-up
15908527|NCT03583957|Device|Observational only|Device is only observational and used to record EEG.
15908528|NCT03583957|Behavioral|Psychological and Behavioral interaction with a seizure forecasting mobile app|Participants will be interacting with a mobile app to input perceived behavioral (e.g., number of hours slept and sleepiness) and psychological (perceived stress).
15908529|NCT03583957|Combination Product|Seizure Alerting and Prediction System|The combination of Epilog (device) and the Aura app (psychological and behavioral interaction) will be used to create a real-time seizure alerting and an hourly seizure forecasting system.
15908530|NCT03583944|Drug|Eribulin Mesylate|Eribulin mesylate IV infusion.
15908531|NCT03583931|Procedure|VATS Decortication|Surgical procedure to unroof all located collections of the pleural space through a chest wall incision
15908532|NCT03583931|Drug|Fibrinolytic Therapy|Instillation of DNAse and tPA together through patient's chest tube already in placed to break down complex fluid collection in the pleural space. DNAse and tPA are are administered together only i.e. are not mutually exclusive.
15908533|NCT03583918|Device|HighThroughput Micro Coring Device|Assess Safety and Efficacy for skin treatments through micro-excisional skin removal with micro-coring device
15908534|NCT03583905|Drug|CKD-330|CKD-330 Tab.
15908535|NCT03583905|Drug|Placebo of CKD-330|Placebo of CKD-330 Tab.
15908536|NCT03583905|Drug|D086|D086 Tab.
15908537|NCT03583905|Drug|Placebo of D086|Placebo of D086 Tab.
15908538|NCT03583905|Drug|D723|D723 Tab.
15908539|NCT03583905|Drug|Placebo of D723|Placebo of D723 Tab.
15908540|NCT03583892|Drug|Gabapentin|One of the groups of patients was exposed to preoperative gabapentin. As the pain has a complex involvement of multiple mechanisms, multimodal analgesic techniques utilizing a number of drugs acting on different analgesic mechanisms are being used. In this case, some patients received gabapentin as a part of a multimodal analgesic technique.
15908541|NCT03583879|Other|Exoskeleton exercise|Functional exercise with a robotic exoskeleton
15908542|NCT03583879|Other|Standard exercise|Functional exercise without a robotic exoskeleton
15908543|NCT03583879|Other|No treatment|Wait-list control
15908544|NCT03583866|Drug|Candesartan|7 days of Candesartan (16mg/day)
15908545|NCT03583866|Drug|Placebo|7 days of Placebo
15908546|NCT03583853|Device|real time PCR|real time PCR will be used for determination of expression of autophagy genes
15908547|NCT03583840|Behavioral|ScreenMen website|An educational website that aims to improve evidence-based health screening uptake in men
15908548|NCT03583827|Other|Virtual reality|Virtual reality is a simulation of the real world generated by computer software and experienced by users via a man-machine interface, providing them with intensive repetition of complex tasks, directed by visual and auditory stimuli, creating dynamic individual-task interaction, a motivating environment and immediate feedback on performance and results, stimulating motor skill learning and motor control of complex behaviors.
15908549|NCT03583827|Other|Conventional physical therapy|Exercises of stretching and strengthening of the upper and lower limbs, as well as coordination, gait and balance.
15908898|NCT03581162|Diagnostic Test|Carotid Ultrasound and venous blood sampling|Carotid ultrasound and blood sampling
15908550|NCT03583814|Behavioral|CASE Program|Controlling Asthma in Schools Effectively (CASE) provides school-based education and environmental assessments. This program takes place over the course of about 4 weeks and involves in-school or remote asthma education for school aged children, after-school or remote education sessions for their parents, asthma care training for school staff, and an evaluation of asthma triggers in the school.
15908551|NCT03583814|Behavioral|HARP Program|Home Asthma Response Program (HARP) is a home-visiting program consisting of 3 home visits or remote sessions (over about 6 weeks). HARP provides individualized asthma education, home-based environmental assessment, and strategies and supplies for controlling environmental asthma triggers.
15908552|NCT03583801|Other|Olfactory aromatherapy|2 drops of the essential oil choosed by the patient are applied on a compress placed next to his head from his arrival in the recovery room to his leaving from the operating theatre. The method of administration is the respiratory tract..
15908553|NCT03583801|Other|without aromatherapy|no intervention
15908554|NCT03583788|Behavioral|Hypnotherapy|The intervention consisted of hypnotherapy given as five one-hour sessions over 5 weeks as individual therapy instead of motivational interviewing.
15908555|NCT03583788|Other|Motivational Interviewing|The intervention consisted of Motivational Interviewing given as five one-hour sessions over 5 weeks as individual therapy instead of hypnotherapy.
15908556|NCT03583775|Other|Cardiovascular Magnetic Resonance Imaging|Cardiovascular Magnetic Resonance Imaging or MRI exam from children's with congenital heart disease
15908557|NCT03583762|Diagnostic Test|Mass spectrometry|Molecular diagnostic test for bacterial identification from bacterial colony
15908558|NCT03583762|Diagnostic Test|Microarray assay|Bacterial identification by Microarray assay from positive blood culture and confirmed by Mass spectrometry technique from bacterial colony. Adjusted antibiotic therapy according to AST Re-evaluation after treatment
15908559|NCT03583749|Drug|Subcutaneous (SC) route for antibiotic treatment|Patients receiving one of the three antibiotics by SC route without any randomization because the route will be chosen before inclusion by the physician in charge.
15908560|NCT03583749|Drug|Intravenous (IV) route for antibiotic treatment|Patients receiving one of the three antibiotics by IV route without any randomization because the route will be chosen before inclusion by the physician in charge.
15908561|NCT03583736|Behavioral|Virtual visit|Virtual visit with oncologist following uterine cancer diagnosis prior to scheduled office visit.
15908562|NCT03583736|Behavioral|Office visit|Scheduled office visit with oncologist following uterine cancer diagnosis.
15908563|NCT03583723|Radiation|Radiotherapy Group|Patients will be immobilized with customized devices. Either four-dimensional CT or slow CT images using a multislice CT scanner will be acquired to evaluate internal target motion. Initially, gross tumor volume (GTV) will be determined in the maximum intensity projection on the initial size of the tumor and involved lymph nodal sites defined as PET-positive nodes and/or a node diameter greater than 1 cm, clinical target volume (CTV) will be defined as equal to the GTV plus node-positive stations and hilar stations, and planning target volume (PTV) will be created equal to the CTV plus a 0.5-cm safety margin. Treatment will be performed with a linear accelerator in a photon regimen, with a 6-to 15-megavolt (MV) nominal energy and three-dimensional (3D) conformal technique.
15908564|NCT03583710|Drug|Cisplatin|Given IV
15908565|NCT03583710|Drug|Etoposide|Given IV
15908566|NCT03583710|Drug|Mitotane|Given PO
15908567|NCT03583710|Other|Quality-of-Life Assessment|Ancillary studies
15908568|NCT03583697|Drug|BMN 111|Subcutaneous injection of 15 μg/kg of BMN 111 daily, Subject to adjustment per protocol
15908569|NCT03583697|Drug|Placebo|Subcutaneous injection of 15 μg/kg of placebo daily, Subject to adjustment per protocol
15908570|NCT03583684|Behavioral|Pivotal Response Treatment Program (PRT-P)|The Pivotal Response Treatment Program (PRT-P) will consist of 3 parent-only sessions (60-90 min) and 13 family sessions with the parent and child (60-90 min). These 16 sessions are once per week over a 16 week period.
15908571|NCT03583658|Drug|ambroxol BIH1526|Pharmaceutical form: lozenges Route of administration: oromucosal
15908572|NCT03583658|Drug|placebo|Pharmaceutical form: lozenges Route of administration: oromucosal
15908573|NCT03583645|Behavioral|Incremental theory of personality|"The experimental intervention (originally developed by David S. Yeager and colleagues) teaches that individuals have the potential to change. It has three main parts. First, participants are asked to read scientific studies that provide evidence that behaviors are controlled by thoughts and feelings in brains, and that pathways in the brain have the potential to be changed under the right circumstances. Second, participants read several testimonials purportedly written by upperclassmen to bring credibility to the ITP. Finally, participants are asked to write their own version of such a narrative. This self-persuasive writing exercise has been shown to facilitate the internalization of the intervention message, building on a long line of research on cognitive dissonance."
15908574|NCT03583645|Other|Educational Intervention|The educational intervention involved scientific information about the human brain. It was designed to be parallel to the experimental intervention and, hence, it has also three main parts. First, participants are asked to read scientific information about the different areas of the brain and their specialties. Second, participants read several testimonials written by upperclassmen about their transition to high school and how their brains help them to adapt to the new space and all the physical differences of the building and the classes. Finally, participants are asked to write a letter to another student explaining the main things he or she has learned about the brain and thinks are important for adapting to the new physical environment in high school.
15908575|NCT03583632|Other|visual acuity testing|testing of visual ycuity by ETDRS charts
15908576|NCT03583632|Device|optical coherence tomography|optical coherence tomography generates sectional slides of the retinal tomography with light
15908577|NCT03583619|Radiation|APBI|Patients receive radiation to the breast tumor bed to a total dose of 40Gy/10fx/2wks, using intensity-modulated radiation therapy technique.
15908578|NCT03583619|Radiation|WBI|Patients receive radiation to the whole breast to a total dose of 43.5Gy/15fx/3wks, using intensity-modulated radiation therapy technique.
15908579|NCT03583606|Biological|ChAd3-EBO-Z|Zaire ebolavirus vaccine administered by an IM injection into the deltoid as a single dose of 2 x 10^11 virus particles (vp)).
15908580|NCT03583606|Biological|MVA Multi-Filo Ebola Vaccine|A booster vaccination of replication defective MVA-BN-Filo administered by an IM injection into the deltoid as a single dose of 1 x 10^8 Infectious Units (IU).
15908582|NCT03583593|Dietary Supplement|DIAMEL|Diamel is administered 6 capsules a day divided into three doses that are ingested before each meal.
15908583|NCT03583593|Dietary Supplement|Placebo|Placebo is administered 6 capsules a day divided into three doses that are ingested before each meal.
15908584|NCT03583580|Radiation|Accelerated Partial Breast Irradiation|Patients are irradiated to the region of tumour bed using intensity modulated radiation therapy (IMRT)
15908585|NCT03583567|Drug|Chlorpheniramine and ranitidine|Patient will receive intravenous chlorpheniramine and ranitidine prior to protamine.
15908586|NCT03583567|Drug|0.9% Normal Saline|Patient will receive normal saline as placebo.
15908587|NCT03583554|Drug|AV-101 720 mg|Single dose of 2 360 mg AV-101 oral capsules + 2 placebo oral capsules
15908588|NCT03583554|Drug|Placebo|Single dose of 4 placebo oral capsules
15908589|NCT03583554|Drug|AV-101 1440 mg|Single dose of 4 360 mg AV-101 oral capsules
15908590|NCT03583541|Behavioral|HIV Risk Reduction|This is an intervention comprised of 4 sessions provided twice per week for 2 weeks of an evidence-based, HIV/STI risk reduction intervention.
15908591|NCT03583541|Behavioral|Financial Literacy|This evidence-based Financial Education Core Curriculum addresses the importance of savings, banking services, budgeting debt management. Undarga adaptation for FSWs included shortening and simplifying sessions while retaining core elements; adding weekly check-ins due to safety concerns FSWs share related to intervention participation, and safety planning as needed. We will further adapt sessions in months 1-6 to assure language and illustrative examples are culturally consonant, and to infuse BE principles consistent with HIVRR. During sessions 1 & 2 we will include information on delay discounting, for example, learning to understand the tendency to prefer small immediate rewards over larger available at a later time; sessions 3 & 4 will include details on economic utility; sessions 5 will contain information on salience (e.g. understanding occasions when women may minimize triggers to unsafe sex); and session 6 will address loss aversion.
15908592|NCT03583541|Behavioral|Mentorship|Mentorship. Mentorship to bridge the transition from FL and savings to a vocational change is a critical component of this intervention. These sessions are intended to support the transition -equipped with financial literacy and savings -to vocational, educational, employment or small business development training using matched savings. The mentorship sessions are adapted from the pilot study and integrate components (e.g., referral and linkage, coaching, exchange visits to model farmers) from income-generating activities provided by our collaborating partner, RTY. All sessions include check-in and individual attention. The first 4 sessions focus on identifying options for vocational, educational, employment or business development training. The second 4 sessions include invited experts in identified areas of interest by group members for more intensive time and attention to individualized needs to make the transition.
15908593|NCT03583541|Behavioral|Matched savings individual development account|A matched savings individual development account (hereafter IDA) is a savings account held at a local bank whereby deposits made by the woman are matched by the intervention to encourage savings and investment in skills and asset development. The accounts introduce women to financial management skills, introduce them to formal financial institutions, and by matching their deposits, incentivize women to save small amounts. Each woman will receive an IDA held in her own name. Women will be allowed and indeed encouraged to contribute up to 50,000 shillings (~15 USD) per month towards their IDAs. The maximum amount of women's contribution to be matched will be an equivalent of US$15 per month for 10 months. During the intervention, monthly account statements will be generated for women to note their accumulated savings. During the intervention, women will have direct access to both their personal savings deposited in the accounts and the match provided by the study.
15908594|NCT03583528|Diagnostic Test|68Ga-DOTATOC PET/CT|"Blood pressure, heart rate, and oxygen saturation levels will be recorded prior to the injection and at 5 - 15 minutes after injection.
~Each study subject will have an intravenous catheter inserted. The subject will receive a bolus intravenous dose of the radiotracer from an approved study supplier site.
~The subject will rest in a comfortable chair for 60 minutes. After this uptake phase, the blood pressure, heart rate, and oxygen saturation levels will be recorded again. The subjects will then be taken to a designated washroom and asked to void prior to being scanned in order to clear excreted radiotracer activity from the urinary tract.
~Subjects are positioned supine, arms down, and centered on the scanner bed and the PET/CT images will be acquired."
15908595|NCT03583528|Diagnostic Test|18F-FDG PET/CT|"18F-FDG PET/CT For 18F-FDG as fasting period of 6 hours is required before the scan.
~Each study subject will have an intravenous catheter inserted. The subject will receive a bolus intravenous dose of the radiotracer from an approved study supplier site.
~The subject will rest in a comfortable chair for 60 minutes. The subjects will then be taken to a designated washroom and asked to void prior to being scanned in order to clear excreted radiotracer activity from the urinary tract.
~Subjects are positioned supine, arms down, and centered on the scanner bed and the PET/CT images will be acquired."
15908596|NCT03583515|Behavioral|Alcohol-Specific Personalized Normative Feedback|Participants will receive personalized normative feedback about drinking.
15908597|NCT03583515|Behavioral|Social Media Personalized Normative Feedback|Participants will receive personalized normative feedback about social media use.
15908598|NCT03583502|Dietary Supplement|krill oil and fish oil supplement|Administration of 2 gelatin soft capsules per day of a combined krill and fish oil supplement, providing 250 mg/day of DHA and 70 mg/day of EPA, for overall 30 days.
15908599|NCT03583489|Drug|APD421|10 mg IV
15908600|NCT03583489|Drug|Placebo|IV
15908601|NCT03583489|Drug|Ondansetron|4 mg IV
15908602|NCT03583476|Drug|Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole|Triple or quadruple therapy consist of Proton pump inhibitor,clarithromycin,amoxicillin or metronidazole.
15908603|NCT03583450|Device|Perioperative virtual reality headset with mobile app|Perioperative virtual reality headset with mobile app (Samsung Gear VR headset, ChariotVR software)
15908604|NCT03583437|Behavioral|Exercise|Moderate Intensity Exercise (50 % af VO2max) for 90 minutes
15908605|NCT03583424|Drug|Carmustine|Given IV
15908606|NCT03583424|Drug|Cytarabine|Given IV
15908607|NCT03583424|Drug|Etoposide|Given IV
15908608|NCT03583424|Procedure|Hematopoietic Cell Transplantation|Undergo hematopoietic cell transplantation
15908609|NCT03583424|Drug|Melphalan|Given IV
15908610|NCT03583424|Drug|Venetoclax|Given PO
15908936|NCT03580811|Device|Dental Implant &ADMG|A dental implant will be placed and the buccal soft tissue will be grafted using ADMG .
15908611|NCT03583411|Other|Epidemiological data collection|To profile each subject enrolled in the study, anamnesis and different personal, clinical, procedural, pharmacological and follow up related variables will be collected. Data collection, maintenance and analysis will be performed using a database that will be developed, managed and updated by study promoter, in accordance with Good Clinical Practice (GCP)
15908612|NCT03583398|Procedure|transcatheter aortic valve implantation, surgical aortic valve replacement|Transcatheter aortic valve implantation using transaortic and transfemoral access and surgical aortic valve replacement.
15908613|NCT03583385|Drug|Glucophage XR (Test drug)|Participants received single oral dose of Glucophage® XR tablet manufactured by PT Merck Tbk, Jakarta, Indonesia (Test Drug) under fasted conditions.
15908614|NCT03583385|Drug|Glucophage XR (Comparator drug)|Participants received single oral dose of Glucophage® XR tablet manufactured by Merck Santé, Semoy, France (Comparator Drug) under fasted conditions.
15908615|NCT03583372|Drug|Vibegron|single daily dose 75 mg
15908616|NCT03583372|Drug|placebos|placebo to match vibegron (experimental drug) and tolterodine (active comparator)
15908617|NCT03583372|Drug|Tolterodine Tartrate ER|single daily dose of 4 mg
15908618|NCT03583359|Device|Radiesse (+)|"Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier with 3% lidocaine hydrochloride (HCl).
~Mode of application: intradermal and/or supraperiosteal injection in the jaw Region. Treated subjects will receive a maximum volume of 3.0 cc of Radiesse (+) per jawline during the initial injection and at the optional Week 48 re-treatment, and 1.5cc per jawline during the optional touch-up."
15908619|NCT03583346|Drug|M6495|Participants will receive escalated dose of M6495 bi-weekly on Day 1, 15 and 29 in cohort 1 to 3 and weekly on Day 1, 8, 15, 22, 29 and 36 in cohort 4.
15908620|NCT03583346|Drug|Placebo|Participants will receive placebo matched to M6495 bi-weekly on Day 1, 15 and 29 in cohort 1 to 3 and weekly on Day 1, 8, 15, 22, 29 and 36 in cohort 4.
15908624|NCT03583320|Diagnostic Test|Cardiac CT angiogram|To the best of the author's knowledge this study will provide the first prospective and randomised data pertaining to hospital length of stay as a primary outcome in the use of CTCA on this acute chest pain cohort (with an intermediate observational zone category) on initial high sensitivity-cardiac troponin (hs-cTn) results presenting to the emergency department in a tertiary care hospital.
15908625|NCT03583307|Drug|Sirolimus|Sirolimus was initiated at a dosage of 0.8 mg/m2 administered twice daily. Subsequently, the sirolimus dosage was adjusted monthly to achieve trough levels between 10 and 15 ng/mL.
15908626|NCT03583294|Other|MRI pelvic|Pelvic MRI
15908627|NCT03583281|Dietary Supplement|Capsules containing flax oil|Capsules containing flax oil to provide 4 grams ALA per day for 4 weeks
15908628|NCT03583281|Dietary Supplement|Capsules containing DHA-enriched fish oil|Capsules containing fish oil to provide 4 grams DHA per day and 0.8 grams EPA per day for 4 weeks
15908629|NCT03583268|Other|Exercise|The intervention will be the different high intensity sessions. Time spent in hypoglycemia and glucose variability will be compared as follows: 70% vs. moderate, 80% vs. moderate, and 90% vs. moderate to see if high intensity is protective against hypoglycemia and provides lower glucose variability levels.
15908630|NCT03583255|Drug|Dexamethasone|Given PO
15908631|NCT03583255|Behavioral|Exercise Intervention|Complete resistance training and moderate intensity walking
15908632|NCT03583255|Other|Placebo|Given PO
15908633|NCT03583242|Drug|Antiangiogenic Agents|3 Intravitreal injections of 0.05 ml of Aflibercept (40 mg/ml) during 3 months (one per month) The clinical management of the patients will be adapted to the treatment standards of the Ophthalmology Service of the Hospital de la Santa Creu and Sant Pau, without the realization of this study influencing such process.
15908634|NCT03583242|Drug|Corticosteroid|1 Injection of dexamethasone intravitreal implant 0.7mg. The clinical management of the patients will be adapted to the treatment standards of the Ophthalmology Service of the Hospital de la Santa Creu and Sant Pau, without the realization of this study influencing such process.
15908635|NCT03583229|Drug|Aspirin 75mg|7 days treatment with 75 mg aspirin daily.
15908636|NCT03583229|Other|Extracorporeal photopheresis|4 x ECP treatments in 60 days.
15908637|NCT03583216|Diagnostic Test|Diabetic pregnancy|Blood samples will be drawn before delivery to evaluate Factor XII level.
15908638|NCT03583216|Diagnostic Test|Non-diabetic pregnancy|Blood samples will be drawn before delivery to evaluate Factor XII level.
15908639|NCT03583203|Device|personalized information about lung damage|Chronic obstructive pulmonary disease (COPD) will be evaluated using spirometry. Based on this value, a motivational message about prevention will be issued for the intervention group, which will be reinforced by individualized text messages over a period of 3 months
15908640|NCT03583190|Other|Cervical-cranial dry needling|Segmental needling of the neck and needling in the patient's headache distribution. Peripherally sensitized areas of the neck may also be dry needled based on the findings of the clinical evaluation.
15908641|NCT03583190|Other|Orthopedic manual therapy|Orthopedic Manual Therapy (OMT) that includes either mobilization or manipulation to the cervical spine applied pragmatically to the most symptomatic level.
15908642|NCT03583190|Other|Thoracic Manipulation|Thoracic Manipulation (applied pragmatically) to the levels determined to be provocative or hypomobile.
15908643|NCT03583190|Other|Exercise|Clinicians select 1 active range of motion exercise for the cervical spine, deep cervical flexion endurance exercise, and 5 upper extremity exercises (from a set of 10). Additionally, patients will be assigned a headache management technique.
15908644|NCT03583190|Other|Patient Education|Patients will receive education regarding their headache condition, proper performance of their symptom management technique, posture.
15908645|NCT03583177|Diagnostic Test|No intervention|No intervention
15908646|NCT03583164|Drug|F901318|30mg tablets with a maximum daily dose of 300mg with dose adjustments according to plasma levels of F901318 and concomitant treatment with CYP inducers or inhibitors
15908710|NCT03582631|Procedure|Emergency abdominal surgery|Emergency surgery for high-risk abdominal pathology using a protocol for optimized perioperative care
15909080|NCT03579875|Drug|Cyclophosphamide (CY) (Plan 1)|10 mg/kg IV daily on days -5, -4, -3, and -2
15908647|NCT03583151|Biological|Amniotic fluid injection|Amniotic fluid contains various proteins that support cell proliferation, movement and differentiation. Amniotic fluid also includes collagen substrates, growth factors, amino acids, polyamines, lipids, carbohydrates, cytokines, extracellular matrix molecules like hyaluronic acid and fibronectin, cells and other chemical compounds that are needed for tissue protection and repair.
15908648|NCT03583151|Biological|Steroid injection|Solu-medrol
15908649|NCT03583138|Drug|buprenorphine|To provide buprenorphine for 12 months for those who are interested in receiving it.
15908650|NCT03583125|Drug|EOC317|tablet(s) PO
15908651|NCT03583112|Drug|Dapoxetine Hydrochloride Tablet|oral one dapoxetine hydrochloride tablet before MRI scan
15908652|NCT03583112|Drug|Placebo Tablet|oral one placebo tablet before MRI scan.
15908653|NCT03583099|Other|COPD plus CAPTURE education and patient-level information|Basic COPD Education plus CAPTURE education and patient-level CAPTURE information will be provided to all practice personnel randomized to the 'CAPTURE + COPD Education' arm.
15908654|NCT03583099|Other|COPD Education Only|Practice clinicians will receive basic COPD education only. Patient-level CAPTURE information will not be provided.
15908655|NCT03583086|Drug|VEGFR/PDGFR Dual Kinase Inhibitor X-82|Given by mouth
15908656|NCT03583086|Biological|Nivolumab|Given by IV
15908657|NCT03583073|Behavioral|Enhanced Referral/Linkage to Care|"The JJ worker reviews with the family psychoeducation material about the role of mental health care in emotional/behavioral problems. The JJ intake worker will contact the CSC program directly with the family for a warm hand-off. The CSC worker will speak with the parent and arrange for an intake evaluation. For families already receiving treatment, the CSC referral will be for consultation. Via phone, the CSC clinician will use a motivational interviewing style to encourage families to attend the appointment. Three and seven days after referral, the JJ worker will text the caregiver to see if the CSC appointment was kept. If not, the JJ worker will text the parent the CSC phone number and also ask permission to contact the CSC to assist the family in setting up another appointment."
15908658|NCT03583073|Behavioral|Standard Care|Referral to the Coordinated Specialty Care (CSC) clinic
15908659|NCT03583060|Behavioral|Mindful Awareness in body-oriented therapy|teaches interoceptive awareness skills for self care
15908660|NCT03583034|Procedure|Holmium laser enucleation of the prostate (HoLEP)|Surgery for benign prostatic hyperplasia
15908661|NCT03583021|Drug|Sugammadex Injectable Product|Sugammadex of 3 mg/kg is injected.
15908662|NCT03583021|Drug|Neostigmine Injectable Product|Neostigmine of 50 ug/kg and Glycopyrrolate of 10 ug/kg are injected.
15908663|NCT03583008|Behavioral|Anticoagulation (AC) Intervention--Academic Detailing|One hour online web-based academic detailing session to develop an anticoagulant (AC) learning plan.
15908664|NCT03583008|Behavioral|Anticoagulation (AC) Intervention--Prescribing Practices|Education and support related to anticoagulant prescribing practices.
15908665|NCT03582995|Procedure|Flap Surgery for root coverage with Alloderm and xenograft|A coronally positioned FLAP technique with AlloDerm® GBR and osseous xenograft will be used for root coverage
15908666|NCT03582995|Procedure|Tunnel Surgery for root coverage with Alloderm and xenograft|A coronally positioned TUNNEL technique with AlloDerm® GBR and osseous xenograft will be used for root coverage.
15908667|NCT03582982|Behavioral|Eccentric overload exercise|12 weeks of 2x per week of the following eccentric exercises: squat, shoulder press, row, and bicep curl.
15908668|NCT03582969|Other|Fecal transplantation|Fecal transplantation administered orally via frozen capsules.
15908669|NCT03582969|Other|Placebo|Placebo capsules
15908670|NCT03582956|Procedure|Euglycemic hyperinsulinemic clamp with tracer enhancement|To characterize the impact of adiposity on metabolism during puberty, adolescents will undergo the euglycemic hyperinsulinemic clamp study with tracer enhancement.
15908671|NCT03582956|Procedure|Euglycemic hyperinsulinemic clamp with tracer enhancement|A comparison control group of 36 lean young adults with T1D will also be enrolled, since they will be unaffected by the adverse metabolic effects of puberty or obesity.
15908672|NCT03582943|Behavioral|RLIC|See descriptions under arm/group descriptions. RLIC is delivered for 7 visits, occurring on consecutive weekdays.
15908673|NCT03582943|Behavioral|Sham conditioning|See descriptions under arm/group descriptions. Sham conditioning is delivered for 7 visits, occurring on consecutive weekdays.
15908674|NCT03582943|Behavioral|Balance training|All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. This is a motor learning task. Participants perform the balance task for 15, 30-second trials per day at visits 3-7.
15908675|NCT03582930|Combination Product|Infasurf Aero|Aerosolization of Infasurf administered to premature babies suffering from RDS. Successful administration of Infasurf by aerosolization will provide two important benefits for patients. (1) endotracheal intubation may be able to be avoided in some patients, and (2) the adverse events at instillation due to filling the airway with liquid and interrupting breathing may be diminished or abolished.
15908676|NCT03582917|Drug|Alphacalcidol|Alphacalcidol 0,5mg tablet
15908677|NCT03582904|Procedure|tDCS|real or sham tDCS delivered to primary motor cortex
15908678|NCT03582891|Device|Summit RC+S for Motor|Using the RC+S pulse generator, investigators will measure cortical biomarkers of hyper and hypokinesia in Parkinson's and dystonia patients to develop an adaptive algorithm which adjusts the level of deep brain stimulation needed based upon the patient's physiology.
15908679|NCT03582891|Diagnostic Test|8-week pilot trial of Closed-loop vs. Open-loop Stimulation|These patients will participate in an 8 week clinical trial of open loop versus adaptive mode (4 weeks for each mode (interleaved), with the order counterbalanced across subjects ).
15908680|NCT03582891|Device|Summit RC+S for Sleep|Using the RC+S pulse generator, investigators will measure cortical biomarkers of sleep stages in Parkinson's patients to develop an adaptive algorithm which adjusts the level of deep brain stimulation needed based upon the patient's physiology.
15908681|NCT03582878|Drug|Sirolimus Oral Product|Oral form of sirolimus, daily dosing to achieve target trough levels between 5-10ng/ml since 1.day of transplantation
15908682|NCT03582878|Drug|Mycophenolate Mofetil|Mycophenolate Mofetil dosing 1g before transplantation and 1g bid afterwards
15908683|NCT03582865|Drug|Tamoxifen 20 mg|Tamoxifen 20 mg is a selective estrogen receptor modulator
15908749|NCT03582332|Drug|Etoricoxib 60 mg|Etoricoxib 60 mg once daily orally
15908684|NCT03582852|Procedure|Surgical treatment of genital prolapse|Laparoscopy performed according to the usual technique of the participating center with pneumoperitoneum between 12 and 15 mmHg. Placement of the 5 mm trocar operator left and right iliac fossa and 5 mm pubic addition.
15908685|NCT03582839|Behavioral|PROTECT+|The early intervention PROTECT+ consists of a cognitive-behavioral 4-session brief-protocol (100 minutes) and targets empirically identified risk factors of (I)GD/IUD, i.e. (1) boredom and motivational problems, (2) procrastination and performance anxiety, (3) social behavior and (4) emotion regulation. It addresses both risk-reduction and strength-promotion by cognitive behavioral (CB) interventions such as (1) psychoeducation, (2) cognitive restructuring (identification and modification of dysfunctional cognition), (3) behavior modification (improving problem solving skills, training of functional behavior and reinforcement) as well as (4) improving emotion regulation (training of sensory, imaginative and mindfulness based techniques).
15908686|NCT03582826|Behavioral|Nutritional counselling|Behavioral nutritional counselling delivered via the Internet.
15908687|NCT03582826|Behavioral|Stress-reduction counseling|The psycho-behavioral intervention includes administering questionnaires and monthly maintenance psychological support delivered via the Internet.
15908688|NCT03582813|Behavioral|Self-directed care|Traditional and non-traditional behavioral health services are chosen from within and outside the public mental health system
15908689|NCT03582813|Behavioral|Services as usual|Traditional behavioral health services are chosen from along those delivered at the patient's community mental health agency
15908690|NCT03582800|Drug|STS|"M0-M6 (run-in phase): medical care and follow-up as usual
~M6-M12 (STS phase):
~Patients with iPPSD2 will be treated with subcutaneous infusion using a portable pump.
~Patients with dermatomyositis or systemic sclerosis will be treated with repeated injections every two weeks.
~Patients will receive a maximal total number of 11 STS injections. M12: final visit (V5): clinical evaluation, photograph and CT scan of the treated lesion, pain and quality of life evaluation."
15908691|NCT03582787|Device|McGrath MAC videolaryngoscopy|Orotracheal intubation with McGrath MAC videolaryngoscopy after anesthetic induction
15908692|NCT03582787|Device|Macintosh Laryngoscopy|Orotracheal intubation with Macintosh Laryngoscopy after anesthetic induction
15908693|NCT03582774|Other|Best Practice|Undergo standard of care
15908694|NCT03582774|Procedure|Computed Tomography|Undergo PET/CT
15908695|NCT03582774|Radiation|Gallium Ga 68-labeled PSMA-11|Given IV
15908696|NCT03582774|Procedure|Positron Emission Tomography|Undergo PET/CT
15908697|NCT03582761|Biological|EV71 vaccine|EV71 vaccine of 320U /0.5ml will be given to 40000 children aged 6-35 months old on day0,28
15908698|NCT03582748|Procedure|sleeve gastrectomy|removal of most of stomach as a bariatric surgical procedure
15908699|NCT03582748|Procedure|No sleeve gastrectomy|Non-receipt of sleeve gastrectomy procedure
15908700|NCT03582735|Other|Nerve gliding exercise|A 4-week home-based nerve-gliding exercise program (NGEP) including isolated and coupled upper limb and neck movements. A specific mobilization was elaborated for each week of the program allowing to gradually increase the range of movement and inter-articular coordination.
15908701|NCT03582722|Drug|Orlistat|One-month supply of orlistat capsules (60mg) to be taken up to 3x daily with meals containing fat, daily multivitamins, and instructions for dietary modification and exercise for six months.
15908702|NCT03582722|Drug|Placebo capsule|One-month supply of placebo capsules to be taken up to 3x daily with meals containing fat, daily multivitamins, and instructions for dietary modification and exercise for six months.
15908703|NCT03582696|Behavioral|CHANGE Study|The CHANGE strategy is designed to improve the dissemination and implementation of CVD EBIs by strengthening clinical-community linkages
15908704|NCT03582683|Behavioral|Chronic Pain Self-Management Program (CPSMP)|Stanford University's Chronic Pain Self-Management Program (CPSMP) was developed by Sandra LeFort in 1996 and based on Stanford's Arthritis Self-Management Program and the Chronic Disease Self-Management Program. The 6-week community-delivered workshop consists of 2.5-hour weekly sessions for people with a primary or secondary diagnosis of Chronic Pain.
15908705|NCT03582670|Behavioral|Strategy Training|Participants will attend four strategy training sessions total. In sessions 1 and 2, in addition to teaching about event- and time-based tasks, the trainer teaches the participant specific strategies for each type of task (implementation intentions for event-based and strategic clock-checking for time-based). In sessions 3 and 4, the trainer tells the participant s/he will be practicing both types of tasks in the training games and can support the participant's strategy use if needed. Feedback on accuracy and strategy use are provided after each training game. At the end of each session after completing the training games, the trainer and participant discuss how the strategies can be applied to the participant's real-life prospective memory goals, and the trainer helps the participant develop written action plans to do so. Plans are reviewed (and modified if necessary) at each session.
15908706|NCT03582670|Behavioral|Process Training|Participants will attend four process training sessions in this group. In sessions 1 and 2, the trainer teaches the participant about event- and time-based prospective memory tasks, respectively. In sessions 3 and 4, the trainer simply tells the participant that s/he will be practicing both types of tasks in the training games. In all sessions, the participant completes the training games with no strategy instruction from the trainer. Feedback on accuracy is provided after each training game. At the end of each session after completing both training games, the trainer reminds the participant of his/her real-life prospective memory goals, provides a handout that lists the goals, and instructs the participant to try to complete them as intended. Of note, even this minimal level of discussion of real-life cognitive tasks is not typical of process training interventions, but we include it to control for that which is occurring in the strategy training group.
15908707|NCT03582670|Behavioral|Control Group|Participants in this group do not attend any sessions during the time the other groups are participating in the Strategy or Process Training
15908708|NCT03582657|Device|dental implant (KONTACT N)|Implant-supported prosthetic restoration
15908709|NCT03582644|Other|Cryotherapy|Crushed ice (1kg) inside a plastic bag (24x34x0,08 cm). The positioning of the plastic bags will cover the entire knee surface (Anterior, lateral and posterior region). After the positioning of the ice bags, they will be fixed with an elastic bandage (compression). To protect the skin against frost bites, all the knee surface will be covered with a moistened operative field (45x50x0,01 cm, 100% cotton)
15908783|NCT03582098|Drug|Rituximab|Tablets were administered in accordance with the marketing authorization.
15908711|NCT03582618|Drug|Sorafenib|Sorafenib will be administered orally at a starting dose of 400mg BID daily and the necessity of dose reduction will be assessed during sorafenib tolerability assessment period
15908712|NCT03582618|Drug|CVM-1118|CVM-1118 will be administered orally at 150 mg BID or 200 mg BID daily and combined with the tolerable dose of sorafenib for a 28-day cycle
15908713|NCT03582605|Drug|Amoxicillin|see previous descriptions
15908714|NCT03582605|Drug|Placebo oral capsule|see previous descriptions
15908715|NCT03582592|Behavioral|Fluid Distribution Timetable|It is a scheduled distribution of pre-determined amounts of fluid intake on a daily basis depicted via a 5x6 table. The timetable includes three major columns. The first column has six timepoints of a day with a four-hour interval. The second column, which was further divided into four sub-columns, reflects the percentage of fluid allotment for food, activities, medication, and thirst encounters. The percentage of fluid allocation was computed based on the patient's prescribed fluid restriction, usual time of food intakes in a day, usual level of activity, time of medication intake, and common time they encounter thirst in a day. Lastly, the third column indicates the converted percentages of fluid allotment in milliliters.
15908716|NCT03582579|Behavioral|Training in Virtual Reality|Action Video Game Based Training in Virtual Reality
15908717|NCT03582579|Behavioral|Training on a computer screen|Action Video Game Based Training on a computer screen
15908718|NCT03582566|Behavioral|Phonological Awareness|Earobics training
15908719|NCT03582566|Behavioral|Working Memory|Cogmed training
15908720|NCT03582566|Behavioral|Phonological Awareness + Working Memory|Earobics + Cogmed training
15908721|NCT03582566|Behavioral|Active Control|Spashmath
15908722|NCT03582553|Dietary Supplement|Naringenin|An extract of Citrus Sinensis containing naringenin and its precursor naringin
15908723|NCT03582553|Other|Placebo|Cellulose
15908724|NCT03582540|Procedure|Double-guidewire cannulation technique|With the DGT, a guidewire is first inserted deep into the PD. The cannulation device is then withdrawn, reloaded with a second guidewire, and reinserted through the working channel of the endoscope to cannulate the common bile duct.
15908725|NCT03582527|Other|all study participants|patients will receive anti-PD-1/anti-PD-L1 antibody for further treatment
15908726|NCT03582514|Radiation|Preoperative brain irradiation (single fraction)|Dose and volume escalation of preoperative single-fraction radiotherapy.
15908727|NCT03582501|Other|Lower body negative pressure|Simulated hypovolemia by applied suction to lower extremities to cause venous pooling.
15908728|NCT03582488|Drug|18F-Flortaucipir|Radioligands for PET imaging of beta-amyloid and neurofibrillary tangle tau pathology
15908729|NCT03582475|Drug|Carboplatin|Given IV
15908730|NCT03582475|Drug|Cisplatin|Given IV
15908731|NCT03582475|Drug|Docetaxel|Given IV
15908732|NCT03582475|Drug|Etoposide|Given IV
15908733|NCT03582475|Biological|Pembrolizumab|Given IV
15908734|NCT03582462|Drug|IONIS FXI-LRx|Ascending single and multiple doses of IONIS FXI-LRx by subcutaneous (SC) injection
15908735|NCT03582462|Drug|Placebo|Sterile Normal Saline (0.9% NaCl) calculated volume to match active comparator
15908736|NCT03582436|Procedure|Kidney transplantation|"For the patients with the kidney transplantation, these parameters will be analysis:
~Transcriptomics analysis Characteristics of anti HLA DSA analysis Non-HLA antibodies analysis Omics blood analysis Urine chemokines analysis"
15908737|NCT03582423|Other|electro-acupuncture|Eight acupoints are chosen: he gu (LI4), nei guan (PC6), qu chi (LI12), ba xie (EX-UE9), zu san li (ST36), san yin jiao (SP6), tai chung (LV3) and ba feng (EX-LE10). The use of ba xie (EX-UE9) and ba feng (EX-LE10) will be optional if skin lesions of hands and feet occurs due to Capecitabine (Xeloda).Disposable acupuncture needles will be inserted at a depth of 10-25mm into the points. We will deliver electrical stimulation with continuous waves at 2 Hz, at an intensity of each patient's minimum sensation of stimulation through the electrical acupuncture stimulation instrument to the points. The needles will be retained in position for 25 minutes.
15908738|NCT03582410|Procedure|laparoscopic sacral colpopexy with absorbable suture|laparoscopic sacral colpopexy to correct pelvic organ prolapse with anterior and posterior meshes with absorbable suture
15908739|NCT03582410|Procedure|laparoscopic sacral colpopexy with non absorbable suture|laparoscopic sacral colpopexy to correct pelvic organ prolapse with anterior and posterior meshes with non absorbable suture
15908740|NCT03582397|Device|Virtual Reality Mirror Therapy|Virtual reality mirror therapy (WiseMind) developed by Realiteer and delivered via Oculus Rift virtual reality platform.
15908741|NCT03582384|Drug|Tocofersolan|After baseline labs are obtained, therapy with tocofersolan will be initiated at an initial dose of 17 mg/kg of d-alpha-tocopherol in the form of tocofersolan (0.34 ml/kg/day) and titrated based on blood levels.
15908744|NCT03582358|Other|Food weighing|Quantification of food intake over three consecutive days (D5, D6 and D7 then D26, D27 and D28) by weighing the food served and the leftovers at and after mealtimes.
15908745|NCT03582345|Procedure|EEG/fMRI|"All the patients recruited will undergo to the following interventions:
~1. Presurgical assesment protocol of the recruited patients (RU1 and RU2) that will includes: (a) detailed medical and epilepsy patients' history; (b) neurologic evaluation; (c) structural 3 Tesla MRI; (d) prolonged video-EEG monitoring including one-overnight EEG recording; (e) neuropsychological evaluation including quality of life evaluation. 2. EEG-fMRI coregistration: All subjects will undergo to a Video-EEG/fMRI study. This protocol will include a 32-channels EEG recorded simultaneously to fMRI data acquisition (3T scanner, Philips). This phase will be articulated in two steps: (i) acquisition of the EEG-fMRI data; (ii) fMRI data analysis (conventional and DCM analysis). RU1 will be charged for both steps. 3. Surgical resection of the epileptic foci and/or intracranial electrode recording (icEEG). The DRE patients in whom an intracranial recording will be considered unnecessary, will be operated at the RU2."
15908746|NCT03582332|Drug|Indomethacin SR, 75 Mg Oral Capsule, Extended Release|Indomethacin SR, 75 Mg Oral Capsule, Extended Release orally twice daily
15908747|NCT03582332|Drug|Indomethacin 25 Mg Oral Capsule|Indomethacin 25 Mg Oral Capsule, 2 capsule orally twice daily
15908748|NCT03582332|Drug|Etoricoxib 90 mg|Etoricoxib 90 mg once daily orally
15908750|NCT03582319|Other|Biodentine|Biodentine is mainly composed of tricalcium silicate, calcium carbonate and zirconium oxides while the liquid contains calcium chloride as the setting accelerator and water reducing agent
15908751|NCT03582319|Other|Formocresol|Formocresol is a devitalizing and fixing agent which was introduced to dentistry since 1904 with full concentration of Buckley's formula (19% formaldehyde, 35 % cresol, and 15 % glycerin in distilled water). A five times diluted formula of Buckley's formocresol was used in this study.
15908752|NCT03582306|Behavioral|High chlorophyll diet - intervention 1st|Participants will be provided frozen dark leafy green vegetables, and counseled to consume 1 cup cooked dark green leafy vegetables (2 servings) daily over the 4 week period while maintaining their normal red meat intake. This will occur during the first 4 week period of the study.
15908753|NCT03582306|Behavioral|High chlorophyll diet - control 1st|Participants will be provided frozen dark leafy green vegetables, and counseled to consume 1 cup cooked dark green leafy vegetables (2 servings) daily over the 4 week period while maintaining their normal red meat intake. This will occur during the last 4 week period of the study.
15908754|NCT03582293|Drug|Tranexamic Acid 500Mg Tablet|orally twice daily for 28 days
15908755|NCT03582293|Drug|Placebo oral capsule|Oral placebo capsule two times a day for a total of 28 days
15908756|NCT03582280|Drug|Amorphous Calcium Carbonate (ACC) - Amor|Amor Powder is composed of Amorphous Calcium Carbonate and is administered oral Amor Inhaled Double Pack is composed of 1% ACC in solution and is administered by inhalation
15908757|NCT03582267|Dietary Supplement|Docosahexaenoic Acid (DHA)|Daily administration of docosahexaenoic Acid (DHA). 2 grams of DHA liquid concentrate administered per day throughout trial period.
15908758|NCT03582254|Radiation|[18F]-FDG PET/MR|"[18F]-FDG PET/MR will be performed in the Department of Nuclear Medicine - Pitié-Salpêtrière Hospital:
~prior to initiation of chemotherapy (rituximab, methotrexate, procarbazine, vincristine and cytarabine) (PET#1),
~after two chemotherapy cycles (PET#2),
~at the end of the first-line chemotherapy regimens (PET#3)."
15908759|NCT03582228|Behavioral|Virtual Envrionment for Social Communication|"Once the Virtual Envrionment for Social Communication intervention begins, participants will meet online from home for one-hour sessions twice a week (twelve sessions over six weeks).
~Weekly sessions will follow a standardized format:
~15 minutes- Social support group (guided discussion of experiences related to weekly topic)
~20 minutes- Didactic instruction
~15 minutes- Role playing
~10 minutes- Debriefing and group feedback"
15908760|NCT03582215|Drug|Part 1: Cream|Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
15908761|NCT03582215|Drug|Part 1: Lotion|Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
15908762|NCT03582215|Drug|Part 1: Spray 1|Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
15908763|NCT03582215|Drug|Part 1: Spray 2|Approximately 2 mg per cm2 of body surface will be applied topically 4 times per day for 4 days to approximately 75% of the body surface area
15908764|NCT03582215|Drug|Part 2: Lotion|Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
15908765|NCT03582215|Drug|Part 2: Aerosol Spray|Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
15908766|NCT03582215|Drug|Part 2: Nonaerosol Spray|Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
15908767|NCT03582215|Drug|Part 2: Pump Spray|Approximately 2 mg per cm2 of body surface will be applied topically 1 time on day 1 and 4 times per day on following 3 days to approximately 75% of the body surface area
15908768|NCT03582202|Procedure|Nutritional assessment and therapy|Nutritional screening, nutritional plan, follow-up and instructions on discharge
15908769|NCT03582202|Procedure|Standard care|Nutritional handling by nurse
15908770|NCT03582189|Other|MRI|Patients who consent to this study will have an abdominal MRI prior to or immediately after each fraction of radiation treatment in the case of those patients that are undergoing SBRT or those receiving palliative treatment. On patients receiving definitive chemoradiation, an abdominal MRI will be performed prior to or immediately after radiation treatment once per week during the any five weeks of treatment
15908771|NCT03582176|Drug|Lactose Placebo|One capsule by mouth twice per day
15908772|NCT03582176|Drug|Ketotifen Fumarate 2mg|2 mg tablets (over-encapsulated into one capsule) by mouth twice per day
15908773|NCT03582176|Drug|Ketotifen Fumarate 5mg|5 mg tablets (over-encapsulated into one capsule) by mouth twice per day
15908774|NCT03582150|Device|Remote Monitoring with Ambulatory Detox|"Each Subject willing to participate will sign an Informed Consent and will receive a Subject Number.
~Study staff will assist Subject in setting up the Soberlink Device as well as the Bluetooth enabled blood pressure cuff and Smartphone APP.
~Study staff documents Subject's resting and standing blood pressure and pulse to establish a safety range for the study.
~Subjects will use the blood pressure cuff and the Soberlink Device four times a day per a set schedule to determine blood pressure and pulse and blood alcohol concentration (BAC). Results will be sent to the Soberlink System for study staff to review.
~If the Subject misses a Soberlink test, tests positive for alcohol, or the identity cannot be approved, the staff will be immediately notified by the Soberlink System.
~The Subject will be enrolled on a Monday and evaluated by the study physician and return to the site for an evaluation by the study physician and staff on Tuesday, and a final assessment on Thursday."
15908775|NCT03582137|Drug|Cannabidiol|Subjects randomized to this arm will receive Cannabidiol Cannabis extract oral solution
15908776|NCT03582137|Other|Placebo|Subjects randomized to this arm will receive Placebo
15908777|NCT03582124|Procedure|Near-Infrared Fluorescence Imaging|Undergo imaging
15908778|NCT03582124|Drug|Panitumumab-IRDye800|Given IV
15908779|NCT03582124|Other|Pharmacokinetic Study|Correlative studies
15908780|NCT03582124|Procedure|Therapeutic Conventional Surgery|Undergo surgery
15908781|NCT03582111|Other|Study of medical records|Study of medical records
15908782|NCT03582098|Drug|Idelalisib|Tablets were administered in accordance with the marketing authorization.
15938195|NCT03355872|Drug|HLX01|Biosimilar of Rituximab
15908786|NCT03582072|Behavioral|letter from the CMO|informed GPs that: The great majority (80%) of practices in England reduced or stabilised their antibiotic prescribing rates in 2016/17. However, your practice is in the minority that have increased their prescribing by more than 4%.*
15908787|NCT03582059|Procedure|High Frequency Spinal cord stimulation|An electrode will be implanted into the patients back. A defined stimulation patter will be applied. The patient will be randomised to received 7-10 days of high frequency stimulation.
15908788|NCT03582059|Procedure|Burst Frequency Spinal cord stimulation|An electrode will be implanted into the patients back. A defined stimulation patter will be applied. The patient will be randomised to received 7-10 days of burst frequency stimulation.
15908789|NCT03582046|Device|Abdominal Perfusion Pressure (APP)|Intra-abdominal Pressure (IAP) actively measured and recorded every four hours, and mean arterial pressure (MAP) adjusted to maintain abdominal perfusion pressure (APP) levels ≥ 60 mmHg.
15908790|NCT03582046|Device|Mean Arterial Pressure (MAP)|Intra-abdominal Pressure (IAP) recorded passively in device, but not measured or reviewed by physician. Patient will be treated with sepsis standard of care, maintaining mean arterial pressure (MAP) of ≥ 65 mmHg.
15908791|NCT03582033|Drug|SEA-BCMA|Given into the vein (IV; intravenously)
15908792|NCT03582033|Drug|dexamethasone|Given by mouth (orally) or by IV
15908793|NCT03582033|Drug|pomalidomide|Given orally
15908794|NCT03582033|Drug|nirogacestat|Given orally
15908795|NCT03582020|Dietary Supplement|menu plans|menu plans, recommendations ensuring an optimal nutrient intake according the guidelines of the German Society of Nutrition
15908796|NCT03582007|Drug|Murepavadin|Murepavadin + ertapenem
15908797|NCT03582007|Drug|One anti-pseudomonal antibiotic|Either meropenem or piperacillin-tazobactam
15908798|NCT03581994|Diagnostic Test|DDI Test Report|Test results of simulated patients
15908799|NCT03581981|Behavioral|Prolonged Exposure for Primary Care (PE-PC)|Brief version of PE provided in 30 minute sessions in PC
15908800|NCT03581981|Behavioral|Treatment as Usual|Veterans assigned to PCMHI-TAU will receive standard PCMHI care for PTSD in PC that does not include any PTSD-specific therapy in PCMHI but may include referral for specialty care (including specialty MH), medication management or general supportive contact while awaiting referral. All PTSD care received during the study will be collected and monitored as TAU.
15908801|NCT03581968|Device|Artificial Pancreas|"The system is composed of 3 main components:
~Insulin infusion pump to infuse insulin. The pump model used in the study is t:slim, Tandem Diabetes Care.
~Continuous glucose monitor (CGM) to continuously measure glucose levels in the interstitial fluid. Glucose levels will be measured by Dexcom G5® CGM.
~MAP application (iMAP) that computes insulin infusion based on the glucose values. The application also alarms the user when glucose sensor values are approaching the hypoglycemic or hyperglycemic range. The iMAP runs on an android smartphone.
~Every 10 minutes, iMAP retrieves the glucose values from the Dexcom G5 CGM via Bluetooth. The application computes an optimal insulin infusion rate based on i) the current glucose reading, ii) the glucose trend (i.e. how quickly the glucose level is rising or falling) and iii) the open-loop basal rates (study parameters). The insulin recommendations are then sent wirelessly via Bluetooth to the insulin pump."
15908802|NCT03581955|Other|Banana Cavendish|240g of fruit plus 150ml of control drink (Fresubin ® 2kcal fiber neutral flavor)
15908803|NCT03581955|Other|Tomato|"300g of raw tomato (coeur de boeuf) with refined sunflower oil (12g) and 150ml of control drink (Fresubin ® 2kcal fiber neutral flavor)."
15908804|NCT03581955|Other|Fresubin ® 2kcal fiber neutral flavor|250 ml Fresubin ® 2kcal fiber neutral flavor
15908805|NCT03581942|Drug|Ibrutinib|(MTD) Dose Escalation level 2: Ibrutinib 840 mg daily
15908806|NCT03581942|Drug|Copanlisib|(MTD) Copanlisib 60 mg weekly (3w on/1w off)
15908807|NCT03581929|Dietary Supplement|Memormax|Memormax is a food supplement indicated to support cognitive functions thanks to the Melissa officinalis; it also contains lyophilized Royal Jelly, Blueberry extract and Blueberry juice.
15908808|NCT03581929|Other|Placebo|Placebo comparator
15908809|NCT03581916|Drug|18F-JNJ-64326067|18F-JNJ-64326067 will be administered intravenously between a dose of 185 Megabecquerel (MBq) to 370 MBq.
15908810|NCT03581903|Biological|H7N3 pLAIV|Approximately 10^7.0 fluorescent focus units (FFUs) administered intranasally by an Accuspray device
15908811|NCT03581903|Biological|H7N9 pIIV|30 micrograms administered by intramuscular (IM) injection
15908812|NCT03581890|Other|Socioeconomic position|"Socioeconomic position is the exposure in both study 1 and 2. Four different socioeconomic measures will be tested. The primary socioeconomic position measure is highest attained education the year before surgery (short/medium/long). Secondary measures are:
~age- and sex-adjusted available income the year before surgery
~Cohabitation status at the year of surgery (living alone/living with a partner) at the year of surgery.
~Urbanicity (in four officially, predefined categories)."
15908813|NCT03581877|Drug|Alteplase|As stated before, low dose r-tpa will be administered through a peripheral vein for PLST.
15908814|NCT03581877|Device|EKOS|As stated before, the EKos device will be used for ultrasound assisted catheter directed thrombolysis or ACDT, same dose t-tpa will administered through the pulmonary catheter. It will be given at a fixed dose over 24 hours.
15908815|NCT03581851|Device|Simulated Altitude: (FiO2: 15.1)|"Inhalation of deoxygenated air through an altitude simulator (Altitrainer) for approximately 1 hour given by a facemask."
15908816|NCT03581851|Device|Shamed Hypoxia (FiO2: 20.9)|"Inhalation of unmodified air through an altitude simulator (Altitrainer) for approximately 1 hour given by a facemask."
15908817|NCT03581838|Behavioral|Observed eating session|Eating a Jimmy Johns turkey or vegetarian sandwich
15908818|NCT03581825|Device|senofilcon A Multifocal|JJVC Investigational Multifocal Contact Lens
15908819|NCT03581825|Device|senofilcon A Sphere|ACUVUE OASYS 2-WEEK with HYDRACLEAR PLUS
15908820|NCT03581825|Device|etafilcon A Multifocal|1-Day Acuvue Moist Brand Multifocal Contact Lens
15908821|NCT03581825|Device|etafilcon A Sphere|1-Day Acuvue Moist Brand Contact Lens
15908822|NCT03581812|Dietary Supplement|Intervention snack 1|To be eaten instead of regular snacks twice a day for 4 weeks.
15908823|NCT03581812|Dietary Supplement|Intervention snack 2|To be eaten instead of regular snacks twice a day for 4 weeks.
15908824|NCT03581812|Dietary Supplement|Control snack|To be eaten instead of regular snacks twice a day for 4 weeks.
15909081|NCT03579875|Drug|Fludarabine (FLU)|35 mg/m2 IV daily on days -5, -4, -3, and -2
15908825|NCT03581799|Other|Oral dispersible tablet|Administration of a 5 mm calcium carbonate based ODT placed in the buccal pouch (children aged 2-5 years) or on the tongue (children aged 6-10 years).
15908826|NCT03581786|Biological|TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy|TORIPALIMAB INJECTION(JS001 ) combine with chemotherapy
15908827|NCT03581786|Drug|Placebos|placebo combine with chemotherapy
15908828|NCT03581773|Drug|Folic Acid|5 mg pr day for 12 weeks
15908829|NCT03581773|Drug|Placebo Oral Tablet|1 placebo pill pr day for 12 weeks
15908830|NCT03581760|Other|Cycling Exercise|Cycling exercise will be performed in the patients once a day.
15908831|NCT03581760|Other|Conventional Physiotherapy|Conventional physiotherapy will be performed in the patients twice a day.
15908832|NCT03581747|Device|Nevisense|Measurement of electrical impedance
15908833|NCT03581734|Biological|Oral Polio Vaccine|OPV is a mixture of live attenuated poliovirus strains of each of the three serotypes, selected by their ability to mimic the immune response following infection with wild polioviruses, but with a significantly reduced incidence of spreading to the central nervous system.
15908834|NCT03581734|Biological|Oral Cholera Vaccine|Bivalent, Killed, Whole Cell Oral Cholera Vaccine
15908835|NCT03581721|Device|enFlow® IV fluid warmer and from July 2019 Fluido®Compact IV fluid warmer|"The fluid warmer will be set up by an external co-investigator in every patient included in the study. It will be turned on in patients belonging to the warming group, and turned off in the control group"
15908836|NCT03581708|Other|lung cancer|If the patient is diagnosed with lung cancer in advanced stage, he/she will be followed up for VTE incidence
15908837|NCT03581695|Other|Blood test|Blood test
15908838|NCT03581682|Other|Tele-Clinic Visits Using Parent-Acquired Echos|"Every patient will have a tele-visit and an on-site clinic visit 1 day apart 3-6 months after the training session. Parents will have a 1-hour hands-on training session to acquire basic echo images on their children with the same hand-held device that they will use during the tele-visit. The parents will also have an in-service on how to take weight, height, and blood pressure measurements, and how to use the digital stethoscope.
~A tele-visit will be schedule a day prior to the patient's regularly scheduled clinic visit. Tele-visit elements will include interim medical history by the parent and patient, and weight, height, vital signs, digital cardiac auscultation, and home echo, all obtained by the parent. Two MFS physicians, following our routine MFS care protocol, will administer either the tele-visit or on-site clinic visit, masked to the findings of the other."
15908839|NCT03581669|Device|Cerclage and total hip arthroplasty|acetabular fractures in the elderly treated with cerclage acetabulum and total hip arthroplasty
15908840|NCT03581656|Device|ChordArt System|The ChordArt System is intended for chordal replacement in mitral valve insufficiency due to leaflet prolapse or flail. One or more ChordArt System may be utilized within the same intervention for optimal mitral valve treatment.
15908841|NCT03581630|Drug|naltrexone/bupropion|Naltrexone hydrochloride (HCl) 8 mg/Bupropion hydrochloride (HCl) 90 mg extended release (ER) combination tablets, orally, one tablet, in the morning, daily, for 1 week, followed by Naltrexone HCl 8 mg/Bupropion HCl 90 mg ER combination tablets, orally, one tablet in the morning and one in the evening, daily, for 7 weeks.
15908842|NCT03581630|Behavioral|Mediterranean Diet|Diet instruction and menu samples from the dietitian on following the Mediterranean Diet.
15908843|NCT03581617|Diagnostic Test|NK cell analysis|"We selected to perform the study during the proliferative phase (day 9-11), where only resident eNK cells are present in the endometrium. The samples will be analyzed with the following methods, that are routinely used in the OUs of the proposal:
~- pNK cell analysis: PBMCs will be purified with Ficoll solution and NK cells will be analyzed by flow cytometry (FacsVantage, BD) with anti-CD56, CD16, CD9, CD49a, KIRs, LILRB1, LILRB2, CD94, CD107a eNK cell analysis: eNK cells will be obtained from endometrial biopsies during proliferative phase, determined by ultrasound scan and analyzed for NK cell subtypes and KIRs, LILRB1, LILRB2, CD94, CD107a expression by flow cytometry"
15908844|NCT03581617|Diagnostic Test|Herpesvirus detection|Herpesvirus detection: DNA will be analyzed by specific primers for HSV-1, HSV-2, EBV, CMV, HHV-6, HHV-7, VZV, and HHV-8, with PCR and nested PCR
15908845|NCT03581617|Diagnostic Test|sHLA-G analysis|sHLA-G analysis: sHLA-G quantification in plasma and endometrial flushing will be performed by ELISA using anti-HLA-G (G233) and anti-beta2-microglobulin HRP-conjugated moAbs (Exbio)
15908846|NCT03581617|Diagnostic Test|HLA-G 14bp INS/DEL typing|Genomic DNA will be genotyped by RealTime PCR
15908847|NCT03581617|Diagnostic Test|sHLA-E analysis|sHLA-E analysis: sHLA-E quantification in plasma and endometrial flushing will be performed by ELISA using anti-HLA-E (3D12, eBioscience) and anti-beta2-microglobulin HRP-conjugated moAbs (Exbio)
15908848|NCT03581604|Diagnostic Test|Allergy work-up|Allergy work-up
15908849|NCT03581604|Other|Blood samples and microbiological samples.|Blood samples and microbiological samples
15908850|NCT03581591|Biological|Burosumab|recombinant human IgG1 monoclonal antibody to fibroblast growth factor 23)
15908851|NCT03581565|Other|zinc polycarboxylate (with the requirements of ISO 9917)|intraoral cementation of single-tooth implant crowns with three different technique, intraoral removal of cement excess upon setting
15908852|NCT03581539|Procedure|Transverses Abdominis Plane (TAP) block|TAP block - Participants will get an injection of bupivacaine and exparel (numbing medicine) in the four different locations of your stomach. To be more specific, the injection placed between your oblique muscles in four different locations right after you are asleep and just before the start of surgery. Investigators will use an ultrasound machine (the machine works by taking pictures of internal organs by bouncing sound waves off them and recording the echoes) to find the abdominal muscle layers and find the correct location to inject the numbing medicine between the muscle layers.
15908853|NCT03581539|Procedure|Quadratus Lumborum (QL) block|QL block - Participants will get an injection of bupivacaine with exparel (numbing medicine) in two locations in your lower stomach. To be more specific, an injection will take place inside your quadratus lumborum muscle which is slightly deeper than your oblique muscles right after you are asleep and right before surgery. Investigators will use an ultrasound machine (the machine works by taking pictures of internal organs by bouncing sound waves off them and recording the echoes) to find the abdominal muscle layers and find the correct location to inject the numbing medicine between the muscle layers.
15908895|NCT03581188|Behavioral|Self-examination of the skin|Participants will use a dermatoscope device to conduct self-examination of the skin.
15908896|NCT03581175|Procedure|Colonoscopy|
15908854|NCT03581539|Procedure|Surgeon Infiltration using Exparel|SI group - at the end of the surgery and just prior to you waking up, the surgeon will use a needle to inject the surgical incision site with bupivacaine and exparel (numbing medicine) spreading the medicine evenly as the needle is slowly withdrawn to make sure all layers are evenly filled with the medicine that will numb the area.
15908855|NCT03581513|Procedure|Deferred or Immediate Stent Implantation|IMR can be used to measure the microcirculatory resistance of coronary artery. It is not clear whether the IMR value could determine the time of PCI for STEMI patients.
15908856|NCT03581500|Drug|Hyperpolarized Carbon C 13 Pyruvate|Given IV
15908857|NCT03581500|Procedure|Magnetic Resonance Spectroscopic Imaging|Undergo MRSI
15908858|NCT03581487|Biological|Durvalumab|Given IV
15908859|NCT03581487|Drug|Selumetinib|Given PO
15908860|NCT03581487|Biological|Tremelimumab|Given IV
15908861|NCT03581474|Device|Bronchoscopic procedure|Single-use flexible bronchoscope aScope 3 Large
15908862|NCT03581461|Behavioral|Trauma-Informed Mindfulness-Based Yoga|The TIMBY program will involve twice weekly, 1-hour long sessions that will incorporate the central elements of Hatha Yoga - breathwork (pranayama), physical postures (asana) and meditation.
15908863|NCT03581448|Behavioral|Sensory Restoration During Prosthesis Control|Human subjects who use a robotic arm/hand interface will experience variable sensations of touch over time.
15908864|NCT03581422|Drug|hCG administration before embryo transfer|Thawed embryo transfer with ovulation triggered by hCG
15908865|NCT03581409|Drug|Aspirin|Aspirin protect tablet
15908866|NCT03581409|Drug|Prasugrel|Prasugrel tablet
15908867|NCT03581409|Drug|Clopidogrel|Clopidogrel 75mg tablet
15908868|NCT03581409|Drug|Cilostazol|Cilostazol tablet
15908869|NCT03581383|Behavioral|PREP-C|The Psychosocial Readiness Evaluation and Preparation for Hepatitis C Treatment (PREP-C) is an interactive online tool that enables providers to provide a thorough assessment of a patient's psychosocial readiness to begin Hepatitis C treatment, and make a treatment plan to improve treatment readiness.
15908870|NCT03581383|Behavioral|Modified ECHO|The heart of the ECHO (Extension for Community Health Outcomes) model is its hub-and-spoke knowledge-sharing networks, led by expert teams who use multi-point videoconferencing to conduct virtual clinics with community providers. The key modification is one patient visit in the specialty center resulting in co-management of patients with data sharing.
15908871|NCT03581383|Behavioral|Patient Telemedicine Questionnaire|The patient questionnaire includes questions about patient experiences with telemedicine visits with providers
15908872|NCT03581370|Drug|1 hour infusion|Intravenous administration of ceftolozane-tazobactam (ZERBAXA®) : 2000 mg by infusion for 60 minutes every 8 hours.
15908873|NCT03581370|Drug|4 hours infusion|Intravenous administration of ceftolozane-tazobactam (ZERBAXA®) : 2000 mg by infusion for 4 hours every 8 hours
15908874|NCT03581357|Behavioral|Mobile Mindfulness Meditation|It is hypothesized that participants who are randomized in the app condition will have significantly less anxiety, pain, fatigue, and sleep disturbance than their counterparts in the control condition.
15908875|NCT03581357|Behavioral|Mindfulness Coach|It is hypothesized that participants who are randomized into treatment condition will have significantly less CIPN, anxiety, and fatigue, and improved anxiety, in comparison to their counterparts in the wait-list control condition.
15908876|NCT03581344|Diagnostic Test|Repetition of Re-staging|Second clinical and instrumental re-evaluation after 11-12 weeks and then surgery 13-16 weeks after the end of chemoradiotherapy if major or complete response at 7-8 weeks
15908877|NCT03581331|Diagnostic Test|orthoptic balance|"Measurement of visual acuity by far: Monocular measurement, right eye, left eye and binocular Measurement of visual acuity closely: Monocular measurement, right eye, left eye and binocular Corneal reflection method or Hirschberg: Analysis of the corneal reflection after fixation of a point of fixation of light from a distance, then from near.
~Cover-Test: Study of the restitution movement following the fixation of the fixation point"
15908878|NCT03581318|Device|MRI|Device
15908884|NCT03581279|Device|T2Lyme Panel testing|The T2Lyme Panel is an investigational use in vitro diagnostic (IVD) designed to qualitatively detect and identify the major causative agents of Lyme disease (Borrelia burgdorferi, Borrelia afzelii, Borrelia garinii, as well as an inclusive Borrelia spp. detection channel) from K2EDTA human whole blood samples.
15908885|NCT03581266|Other|Rye/Wheat|Mechanistic study of glucose kinetics after ingestion two kinds of bread
15908886|NCT03581253|Other|"Facial disability Index (FDi)"|questionnaires regarding to quality of life
15908887|NCT03581253|Other|"Facial Clinimetric Evaluation (FaCE)"|questionnaires regarding to quality of life
15908888|NCT03581240|Drug|eflornithine HCl|"In this study subjects without CNS disease will receive oral difluoromethylornithine (DFMO) at a dose of 500 to 1000 mg/m2 BID
~Subjects with CNS disease will receive a dose of 2500 mg/m2/dose BID in order to facilitate crossing into the CNS."
15908889|NCT03581227|Other|CAPTURE Tool|CAPTURE Tool: a self administered 5-item questionnaire with peak expiratory flow measurements
15908890|NCT03581214|Other|No oxygen|No facemask, room air only
15908891|NCT03581214|Other|Oxygen|10Liters/minute oxygen by facemask
15908892|NCT03581201|Diagnostic Test|Laboratory measurements|"Laboratory measurements will be collected every week during the Duration of one menstrual cycle and includes the following:
~Hormone analysis
~Clinical chemistry
~Complete blood count
~Adipokines
~Glucose and HbA1c-levels
~Urinary Chemistry"
15908893|NCT03581201|Diagnostic Test|Stool samples|For a Duration of one menstrual cycle the study participants will be instructed to collect stool samples every two days. The investigation of the intestinal microbiome will be done by sequencing the 16S rRNA gene.
15908894|NCT03581201|Diagnostic Test|Bioimpedance analysis|The Bioimpedance analysis (BIA) is used for the measurement of body composition and will be done at every study visit.
15908897|NCT03581175|Drug|Bowel cleansing regimen|
15908899|NCT03581149|Drug|Sodium Picosulfate/Magnesium Citrate Laxative|● First arm: Patients will receive sodium picosulfate/magnesium citrate (Citrafleet®) solution with an instruction leaflet.
15908900|NCT03581149|Drug|2L polyethylene glycol/ascorbic acid|"First arm: Patients will receive sodium picosulfate/magnesium citrate (Citrafleet®) solution with an instruction leaflet.
~Second arm: Patients will receive 2L polyethylene glycol + ascorbic acid (MoviPrep®) solution with an instruction leaflet."
15908901|NCT03581136|Device|Dose Fractionation|Patients will receive 5 fractions of radiation. These should not be on consecutive days. At least 40 hours between each fraction and a maximum of 21 days to complete, i.e.: Tuesday, Thursday, Monday, Wednesday, Friday.
15908902|NCT03581123|Behavioral|Supported-Self Management (SSM)|Provides low back pain sufferers opportunities to develop the capacity and motivation to self-manage their pain in an adaptive manner. This includes psychological/behavioral strategies, mind-body approaches, lifestyle advice, pain education and pain coping.
15908903|NCT03581123|Other|Spinal Manipulation Therapy (SMT)|"Due to Covid-19, this arm is temporarily suspended until in-person clinic visits resume.
~SMT will address the biological and physical aspects of low back pain (e.g. spinal dysfunction) with the intention of restoring maximum movement and functional ability of the spine."
15908904|NCT03581123|Combination Product|SMT + SSM|"Due to Covid-19, this arm is temporarily suspended until in-person clinic visits resume.
~Combination Treatment"
15908905|NCT03581123|Drug|Standard Medical Care (SMC)|Guideline based medical care informed by the American College of Physicians' guidelines on noninvasive treatment for low back pain.
15908906|NCT03581110|Diagnostic Test|computed tomography|noncontrast-enhanced chest computed tomography
15908907|NCT03581097|Other|Video Group|Patients in the film group watched the film using a laptop computer equipped with headphones, and Visual Analog Pain Scale (VAS) was repeated after the movie. Video was recorded by the Anaesthesiology department team, in order to explain and show in a detailed way on a model, the sequence of events, which occurs between the arrival of patients in the operating room and the performance of Intra-Venous Regional Anesthesia (IVRA)
15908909|NCT03581071|Drug|TS-143|
15908910|NCT03581058|Drug|Cannabis|Participants will be assigned to consume one of the cannabis strains and will complete testing immediately after consumption.
15908911|NCT03581032|Device|Active reprogam|Reprogram Changes in AV/PV delays
15908912|NCT03581019|Procedure|uterus transplantation|uterus transplantation from deceased donor
15908913|NCT03581006|Dietary Supplement|Low-Calorie Mediterranean Diet|Participants in the intervention group will receive 6 months of education and behavioral counseling with self-monitoring to help them adopt a Mediterranean-style, calorie-restricted diet, and engage in physical activity
15908914|NCT03581006|Combination Product|Technology based monitoring and behavioral participation|Intervention participants will use smart phones to connect to intervention applications, WebEx, MyNetDiary
15908915|NCT03581006|Other|Usual care group|Control group, who will receive no dietary or behavioral intervention during the trial
15908916|NCT03580993|Diagnostic Test|Lung Ultrasound|Lung ultrasound and Echocardiography used to derive parameters for prediction of successful SBT.
15908917|NCT03580980|Drug|Paracetamol and ketamine|intravenous paracetamol and ketamine followed by ketorolac
15908918|NCT03580980|Procedure|Caudal levobupivacaine|an epidural injection of morphine and levobupivacaine through the caudal space
15908919|NCT03580980|Drug|Morphine|patient controlled analgesia by morphine
15908920|NCT03580967|Drug|Vortioxetine|Oral pill to be taken daily for 8 weeks, 10 or 20 mg dosage. Participants who cannot tolerate this dose may be reduced to 5mg dose.
15908921|NCT03580954|Device|Transcranial Magnetic Stimulation|Stimulation or inhibition using TMS will be delivered guided by a neuronavigator system in different brain regions.
15908922|NCT03580928|Drug|Venetoclax|Venetoclax is an oral drug that blocks the function of a protein called BCL-2. CLL cancer cells are thought to depend on the BCL-2 protein for their survival. By blocking BCL-2, venetoclax may kill cancer cells or stop them from growing.
15908923|NCT03580928|Drug|Obinutuzumab|Obinutuzumab is a type of drug called a monoclonal antibody. It targets a protein CD20 on the surface of the CLL cell, causing it to die
15908924|NCT03580928|Drug|Acalabrutinib|Acalabrutinib is a type of drug called a kinase inhibitor. It blocks a type of protein called Bruton Tyrosine Kinase (BTK) that helps CLL cells live and grow
15908925|NCT03580915|Behavioral|Functional Literacy Program|The intervention will be provided twice weekly in 2-hour sessions, over 8 weeks. The 16 intervention sessions will provide the opportunity for participants to learn functional literacy skills to (1) manage an apartment, (2) access community resources, (3) manage finances, (4) access free recreational activities. All sessions will address literacy skills needed to complete basic daily life activities in the home and community environments. Literacy skills will first be learned and practiced within the supported shelter, and then extended to the community.
15908926|NCT03580915|Behavioral|Usual Care Management Services|The control group will receive the usual housing services without additional intervention.
15908927|NCT03580902|Behavioral|CBT4CBT-Buprenorphine|Computerized, user-driven cognitive-behavioral therapy (CBT) web-based program adapted for use in office based buprenorphine treatment
15908928|NCT03580902|Drug|Buprenorphine/naloxone|Standard outpatient buprenorphine maintenance
15908929|NCT03580889|Drug|Atropine|Comparison between atropine, glycopyrrolate and Normal Saline
15908930|NCT03580889|Drug|Glycopyrrolate|Comparison between glycopyrrolate, atropine and Normal saline
15908931|NCT03580889|Drug|Normal Saline Flush, 0.9% Injectable Solution|Comparison between Normal saline, atropine and glycopyrrolate
15908932|NCT03580876|Drug|addition of azathioprine|impact of addition of azathioprine after a switch of a second anti-TNF agent
15908933|NCT03580876|Drug|Switch to a second anti-TNF drug alone|Switch to a second anti-TNF drug alone without addition of azathioprine
15908934|NCT03580850|Other|No intervention in this restrospective study|This study is an obervational study
15908935|NCT03580824|Biological|R21 in Matrix- M adjuvant vaccine|R21: Protein particle malaria vaccine candidate in Matrix-M: Saponin based vaccine adjuvant.
15908937|NCT03580811|Device|Dental implant & ADMG & BDX|Dental Implant will be placed with ADMG that covers the BDX
15908938|NCT03580798|Procedure|Delayed graft|8 weeks post-extraction 15 test patients will receive implant placement plus osseous grafting.
15908939|NCT03580798|Procedure|Simultaneous graft|At the time of extraction osseous graft will be placed in the socket and implant placed 4 months later.
15908940|NCT03580785|Genetic|genetic analysis|saliva is collected for DNA extraction
15908941|NCT03580785|Radiation|panoramic radiography|panoramic radiography
15908942|NCT03580785|Radiation|teleradiography|teleradiography
15908943|NCT03580785|Radiation|intraoral X-rays|intraoral X-rays
15908944|NCT03580785|Radiation|CT scan of maxillary and mandible|CT scan of maxillary and mandible
15908945|NCT03580772|Device|Persona TKR|Persona® TKR (Zimmer Biomet)
15908946|NCT03580772|Device|Attune TKR|Attune® TKR (Depuy synthes)
15908947|NCT03580759|Behavioral|PREHAB|After three supervised training sessions, subjects will be asked to participate in a daily exergaming activity tailored to their physical activity capabilities and needs. Subjects will be taught to rate their perceived exertion and monitor their target heart rate using a Fit Bit Charge HR. Daily exercise diaries will be used to monitor subject-perceived progress throughout the intervention period.
15908948|NCT03580746|Procedure|Taping and posteromedial release|
15908949|NCT03580746|Procedure|Ponseti|
15908950|NCT03580733|Drug|caspofungin antifungal therapy|caspofungin
15908951|NCT03580733|Other|placebo|placebo
15908952|NCT03580720|Other|Inspiratory threshold loading protocol|Subjects will be instrumented with catheters that measure electrical activity of the diaphragm and transdiaphragmatic pressure. Subjects will perform a stepwise inspiratory threshold loading protocol to induce a wide range of diaphragm activity.
15908953|NCT03580707|Drug|BRV vs LEV in randomized double blinded, crossover fashion|Single dose intravenous administration of BRV 100 mg over a 15 minutes period. On a subsequent occasion, (approximately 2 weeks later), the patient is crossed over to the other drug at a singular dose. On both occasions, intermittent photic stimulation is done 10 times in a two hour period. IPS is again conducted in the cross over portion as well. Coincident with IPS stimulation 10 blood samples will be drawn for BRV or LEV plasma concentration.
15908954|NCT03580694|Drug|REGN4659|REGN4659 will be administered by intravenous (IV) infusion.
15908955|NCT03580694|Drug|Cemiplimab|Cemiplimab will be administered by intravenous (IV) infusion.
15908956|NCT03580681|Other|Plant-based diet|Weekly instructions will be given to the participants in the intervention group about following vegan diet.
15908957|NCT03580681|Dietary Supplement|Supplement|Unrestricted diet with clinically insignificant amount of omega- 3 oils and vitamin E
15908958|NCT03580668|Drug|B/F/TAF|B/F/TAF administered in accordance with the approved product monograph
15908959|NCT03580655|Drug|Avapritinib|Avapritinib tablet
15908960|NCT03580642|Device|eHealth Technologies|The controls will get a conventional treatment from the acute to the chronic phase of stroke and the cases will get a conventional treatment till the end of the subacute phase. However, in the chronic period they will use the developed STARR App and DSS, as well as commercial wearables.
15908961|NCT03580629|Behavioral|Liver Live Donor Champion Program|Even with adequate education of live donation, many liver transplant candidates still feel ill equipped to ask others to consider donating. Friends and family are often eager to help and may not be able to serve as donors themselves, but might be able to provide instrumental support. A Live Donor Champion (LDC) is a friend or family member who serves as an advocate for the candidate in their pursuit of live donation. The Johns Hopkins Comprehensive Transplant Center has developed the Liver Live Donor Champion program to provide education and advocacy training to waitlist candidates and their LDCs. The support provided by the LDC bridges a critical link between education and action. Using LDCs to increase live donation is a novel approach that has garnered widespread enthusiasm.
15908962|NCT03580616|Drug|L-Serine|L-Serine is a naturally occurring dietary amino acid. It is abundant in soy products, some edible seaweeds, sweet potatoes, eggs and meat.
15908963|NCT03580603|Other|Visualization tool|Visual representation of past microbiological culture data
15908964|NCT03580590|Drug|oral Diltiazem|Diltiazem, a calcium channel blocker reduced arteriolar tone and fall in blood pressure
15908965|NCT03580590|Drug|IV Tranexamic Acid|Tranexamic acid inhibits fibrinolysis, which reduces blood loss
15908966|NCT03580590|Drug|Placebo Oral Tablet|Placebo Oral Tablet
15908967|NCT03580577|Device|thromboelastography|thromboelastography will assess all coagulation abnormalities including platelets function in cirrhotic group with venous thromboembolism , and guide us about is there increased thrombosis risk or not, for that a fresh blood sample will be withdrawn from each patient before starting any treatment
15908968|NCT03580564|Drug|KL-A167|KL-A167 900 mg intravenously (IV) every-2-weeks (Q2W)
15908969|NCT03580551|Behavioral|Intervention Group|"Intervention group participants will receive the home-based DVD chair exercise program, which will include a DVD player, Sit and Be Fit DVD, schedule of exercise sessions, hand weights, exercise balls, resistance bands, exercise log, and satisfaction survey. Participants will be instructed to complete an assigned Sit and Be Fit exercise session once a day (sessions last approximately 30 minutes), five days a week (Monday-Friday) for 8 weeks. During the first 6 weeks, the intervention group will not have contact with the study team, unless to trouble-shoot the DVD or answer questions about exercise sessions. At the end of week 6, the intervention group will be contacted to schedule a post-assessment for the end of week 8, which will include repeating all health measures, except for health status."
15908970|NCT03580551|Behavioral|Waitlist Control Group|"At week 8, waitlist control group will receive the home-based DVD chair exercise program, which will include a DVD player, Sit and Be Fit DVD, schedule of exercise sessions, hand weights, exercise balls, resistance bands, exercise log, and satisfaction survey. The waitlist control group will complete a post-assessment at the end of week 8, which will include all health status measures, except health status. Waitlist control group will be instructed to complete an assigned Sit and Be Fit exercise session once a day (sessions last approximately 30 minutes), five days a week (Monday-Friday) for 8 weeks. Waitlist control group will not have contact with the study team, unless to trouble-shoot the DVD or answer questions about exercise sessions. At the end 14 weeks, waitlist control group will be contacted to schedule a final meeting, and to collect the adherence logs and satisfaction survey. At 16 weeks, the waitlist control group will not receive an additional post-assessment."
15908971|NCT03580538|Other|resistive exercise with elastic tube|performed training with elastic tubing for six weeks, twice a week and the load was progressively increased every 15 days.
15908972|NCT03580525|Drug|Nicotine saline infusion 0.00mcg/kg/s|saline 0.00mcg/kg/s
15908973|NCT03580525|Drug|Nicotine infusion 0.24mcg/kg/s|nicotine 0.24mcg/kg/s
15908974|NCT03580525|Drug|Nicotine infusion 0.096mcg/kg/s|nicotine 0.096mcg/kg/s
15908975|NCT03580525|Drug|Nicotine infusion 0.048 mcg/kg/s|nicotine 0.048mcg/kg/s
15908976|NCT03580525|Drug|Nicotine infusion 0.024mcg/kg/s|nicotine 0.024mcg/kg/s
15908977|NCT03580499|Dietary Supplement|Vitamin B6|Given PO
15908978|NCT03580486|Other|The squares test|The squares test (ST) originally used in handedness is modified. The ST is a reliable, not time-consuming and easy to administer test for evaluated hand function.
15908979|NCT03580473|Drug|SATURNO II association|opthalmic solution, 4 times a day
15908980|NCT03580473|Drug|Vigadexa®|opthalmic solution, 4 times a day
15908981|NCT03580460|Behavioral|Computer delivered smoking cessation counseling|15 to 20 minute computer-delivered interactive smoking cessation counseling
15908982|NCT03580447|Dietary Supplement|Citrus extract|Citrus extract
15908983|NCT03580447|Dietary Supplement|Placebo|Maltodextrin
15908984|NCT03580434|Device|V-STRUT|Minimally invasive implantation of V-STRUT
15908987|NCT03580408|Drug|Nivolumab|240 mg
15908988|NCT03580408|Drug|Vinblastin|6mg/m²
15908989|NCT03580395|Drug|Apatinib|500mg, day1-21,neoadjuvant therapy
15908990|NCT03580395|Drug|paclitaxel|paclitaxel 165mg/m2 day 1
15908991|NCT03580395|Drug|cisplatin|cisplatin 40mg, day 1-3
15908992|NCT03580382|Drug|Trametinib daily Until PD|1.0 mg daily
15908993|NCT03580382|Drug|CDX-3379 (ERBB3 antibody)|15mg/kg IV Q3W
15909000|NCT03580343|Drug|tofacitinib|tofacitinib extended release, 11mg, daily, oral
15909001|NCT03580330|Other|mHealth intervention|Individual in the intervention group receive a weekly educational health SMS for the intervention period of 1 year. SMS content covered different health themes providing health information on lifestyle, dietary habits, body weight, smoking, medications, importance of compliance, as well as symptoms and self-management of HTN and diabetes. Community individuals who were diagnosed and were receiving necessary care previous to the investigator's intervention were sent weekly informative health SMS, as well as customized SMSs reminders to follow up on their scheduled medical appointments (eg, to check their HbA1c levels and have their annual foot or eye exams).
15909002|NCT03580317|Other|EA+ Carbamazepine|"Acupoints selection: Si-bai(ST2), Xia-guan(ST7), Di-cang(ST4), Quan-liao(SI18), Jia-che(ST6) and A-shi-xue of affected side. He-gu(LI4) and Wai-guan(TE5) of two sides.
~Operation:The needles(0.18×25 mm) will be selected to stimulate the local points with shallow row needling according to the distribution of neuropathy branch of trigeminal neuralgia.The needles(0.25×40mm) will be selected to stimulate the distal acupoints. The Xia-guan(ST7) and Quan-liao(SL18) (or Jia-che(ST6)), He-gu(LI4) and Wai-guan(SJ5) acupoints will be received EA treatment by HuaTuo SDZ-ⅡB acupoint neural stimulator. The EA parameter is 2/100 Hz, 60 minutes and the current intensity is comfortable to subjects. Carbamazepine tablets should be took orally, 0.1g each time, thrice daily."
15909003|NCT03580317|Other|EA+Placebo|In this group, the selection, positioning and manipulation of acupoints, the frequency, duration and retaining needle time of treatment are same as EA + Carbamazepine Group; placebo, that appearance and specifications are the same as carbamazepine, are cooperated taken of dose 0.1g, thrice daily.
15909004|NCT03580317|Other|sham EA+Carbamazepine|"Selection of points and locations: the non-meridional points which are means to the points beside 5-10mm of the real acupoints (avoid the trigger point) in the EA group will be selected and needled with more shallow acupuncture (the depth of needling is about 1-2mm).
~The operation of shame EA: The HuaTuo SDZ-ⅡB acupoint neural stimulator with damaged electrode wires will be selected to connect the points next to the Xia-guan(ST7) and Quan-liao (SI18) , He-gu (LI4) and Wai-guan(TE5).The frequency, intensity and retaining time will be same as EA group, The subjects can see the display screen and parameter settings of stimulator, however there is no electricity output in fact.
~The dosage and frequency of oral carbamazepine tablets are same as above part."
15909005|NCT03580317|Other|sham EA+Placebo|The points selection, positioning and manipulation are same as Shame EA+ Carbamazepine group，placebo are cooperated taken of dose 0.1g, thrice daily.
15909006|NCT03580304|Behavioral|Industrial work|Subjects perform simulated industrial work in lab setting. The industrial task exists of a physical component and a cognitive component. Physical load is measured by questionnaires and basic physiological measurements (e.g. heart rate). Mental fatigue will be determined by questionnaires and a cognitive stroop task before and after the trial.
15909007|NCT03580304|Behavioral|Physical load|The physical load of an industrial task will be simulated during this intervention. Physical load is measured by questionnaires and basic physiological measurements (e.g. heart rate). Before and after the trial, mental fatigue will be determined by questionnaires and a cognitive stroop task (10 min)
15909008|NCT03580304|Behavioral|Cognitive load|The cognitive load of an industrial task will be simulated in this intervention. Physical load is measured by questionnaires and basic physiological measurements (e.g. heart rate). Before and after the trial, mental fatigue will be determined by questionnaires and a cognitive stroop task (10 min)
15909009|NCT03580291|Other|Mesenchymal stem cells|The group receive pulse infusion of MSCs once of 2 x 10^6/kg body weight
15909010|NCT03580291|Drug|Mycophenolate Mofetil|This group receive oral MMF of 2.0 g / d.
15909011|NCT03580291|Other|Placebo of Mesenchymal stem cells|The group receive placebo of Mesenchymal stem cells.
15909012|NCT03580291|Drug|Placebo of Mycophenolate Mofetil|The group receive placebo of oral mycophenolate mofetil.
15909013|NCT03580278|Biological|ABY-035/AFO2|Analyze the safety, tolerability, PK, and efficacy of ABY-035/AFO2 that 25 subjects will receive for treatment of their active plaque psoriasis
15909014|NCT03580265|Device|laser phototherapy device with low level laser|The wavelength of low level laser is 808nm and the power output of low level laser is 300mW.
15909015|NCT03580252|Other|Correlation analyses for the outcomes|No medical intervention would be done. The single arm would receive regular practice of Hammersmith Assessment and MRI / Ultrasound
15909016|NCT03580239|Drug|Everolimus|Everolimus will be treated at a dose of 10mg/day orally once a day. One cycle of therapy consists of 28 days. The patients also receive the best supportive care.
15909017|NCT03580239|Drug|Placebo|Placebo will be treated at a dose of 10mg/day orally once a day. One cycle of therapy consists of 28 days. The patients also receive the best supportive care.
15909018|NCT03580226|Other|No intervention|No intervention
15909019|NCT03580213|Other|Hand therapy MCPJ affected|Prevention of oedema, treatment of scar, splinting to maintain or improve extension, exercises, activity of daily living as exercise. Instructions, demonstration and advices.
15909020|NCT03580213|Other|Hand therapy PIPJ affected|Prevention of oedema, treatment of scar, splinting to maintain or improve extension, exercises, activity of daily living as exercise. Instructions, demonstration and advices. Possible additional splint and exercises specifically for the PIPJ extension.
15909021|NCT03580200|Other|Trigger Point Dry Needling|For the purposes of this study, the term trigger point dry needling will be used to describe deep dry needling of muscle tissue. The goal of trigger point dry needling is to eliminate myofascial trigger points within muscle tissue, thereby reducing pain as well as improving motor control and function (Caramagno et al., 2015; Dommerholt et al., 2006; Shah et al., 2015). Trigger point dry needling utilizes a solid filiform needle and focuses on the penetration of a palpable myofascial trigger point at various depths. The needle is then manipulated within the tissue in an attempt to elicit a localized twitch response. Once the localized twitch response has ended, the needle is removed and another myofascial trigger point is located.
15909022|NCT03580187|Drug|Morphine (+)|"We performed a first nebulization of 10 mg (1mL) of morphine diluted in 4 mL of normal saline using a nebulizer with an oxygen flow rate of 8 L / min. The quality of analgesia was assessed by VAS at rest and cough after 10 minutes. If ≤ 4, we concluded to a success. If VAS was still> 4, a second nebulization was performed. After 20 minutes, if VAS still higher than 4 we performed a third nebulization. If pain level was ≤ 4, we concluded to a success. After 30 minutes, if VAS still> 4, we concluded to a failure of morphine nebulization.
~The patients were divided into two groups:
~morphine (+) group: good response to morphine in nebulization morphine (-) group: failure of morphine in nebulization"
15909023|NCT03580174|Other|Goal directed physiotherapy group|Ten children with CP will receive structural, comprehensive activity based, goal directed therapy protocol one hour in a session, 2 times in a week during 8 weeks. GDPT will be a structural protocol and consists of daily life activities as sit to stand and reach, treadmill exercises, balance exercises with bosu-ball, orthotics, home program, following with exercise-diary.
15909024|NCT03580174|Other|Routine physiotherapy group|Ten children with CP will RPT applications will consist of unstructured stretching exercises, massage, passive range of motions, muscle strengthening, orthotics etc.) one hour in a session, 2 times in a week during 8 weeks.
15909025|NCT03580161|Other|18-F FDG PET/CT dosimetry scans and measurements|Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
15909026|NCT03580161|Other|Ga-68 PSMA PET/CT dosimetry scans and measurements|Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
15909027|NCT03580161|Other|68-Ga Dotatate PET/CT dosimetry scans and measurements|Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
15909028|NCT03580161|Other|99mTc Pertechnetate Thyroid dosimetry scans and measurements|Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
15909029|NCT03580161|Other|99mTc DMSA(III) Renal dosimetry scans and measurements|Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
15909030|NCT03580161|Other|99mTc MAG3 Renal dosimetry scans and measurements|Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
15909031|NCT03580161|Other|99mTc MDP Bone dosimetry scans and measurements|Participants will have additional scans and retention measurements for dosimetry alongside their routine diagnostic scans
15909032|NCT03580148|Drug|Cortisone|Patients randomized to receive this study intervention will undergo one ultrasound guided 80mg Depo Medrol GHJ injection
15909033|NCT03580148|Biological|Bone Marrow Aspirate|Patients randomized to receive this study intervention will have, under sterile conditions and after injection of local anesthetic, 10 mls of bone marrow aspirate taken from the posterior superior iliac spine and injected under ultrasound guidance to the glenohumeral joint
15909034|NCT03580135|Drug|Propolis|One and half gram of Standardized Propolis Extract powder (Y.S. Eco Bee Farms Propolis Powder) at 100% was mixed with 1.75 mL of polyethylene glycol (Continental Chemicals, New Delhi, India) to form a thick consistency on a clean dry glass slab with a metal spatula. The paste was carried to the pulp stumps with a metal carrier and then condensed lightly to a thickness of 2 - 3 mm followed by placement of thick mix of GIC to seal the cavity and covered by st.st crown.
15909035|NCT03580135|Drug|Mineral Trioxide Aggregate|MTA paste will be prepared as per the manufacturers' instructions to obtain a putty-like consistency. The mixture will be delivered to the pulp stumps and condensed lightly with a moistened sterile cotton pellet to ensure a thickness of 2 to 3 mm. A thick mix of glass ionomer cement (GIC) will applied over the MTA and covered by st.st crown.
15909036|NCT03580122|Drug|Arginine Aspartate|Asparten
15909037|NCT03580109|Other|Immediate spa treatment|Spa treatment linked education therapeutic in lymphoedema post breast cancer (whirlpool bath with automatic air and water massage cycles, massaging shower/individuals and groups educational sessions)
15909038|NCT03580109|Other|Late spa treatment|Spa treatment linked education therapeutic in lymphoedema post breast cancer (whirlpool bath with automatic air and water massage cycles, massaging shower/individuals and groups educational sessions)
15909082|NCT03579875|Drug|Methylprednisolone (MP)|1 mg/kg IV q12h on days -5, -4, -3, -2, and -1
15909492|NCT03576638|Drug|Sinemet CR 25Mg-100Mg Extended-Release Tablet|25/100 1.5 pills five times/day
15909039|NCT03580096|Other|Core stability|Core stability intervention will be done with different stages and increasing gradually. The training program starts with exercises that isolate specific core muscles but progressing to include complex movements and incorporate core stability in dynamic tasks.
15909040|NCT03580096|Other|Standard intervention|Standard intervention will include active exercises based on active joint mobilizations, muscle stretching and motor coordination.
15909041|NCT03580083|Genetic|RGX-111|Recombinant adeno-associated virus serotype 9 capsid containing α-L-iduronidase expression cassette
15909042|NCT03580070|Biological|Immunotherapy|Patients with primitive head and neck squamous cells carcinoma diagnosed on surgical resection or biopsic sample, between 2008 and 2015. They were included when expressing p16 as assessed by immunochemistry and positive HPV DNA by in situ hybridation or positive HPV PCR
15909043|NCT03580057|Behavioral|Breastfeeding promotion intervention|Promotion (education, support and supervision) of breastfeeding by experienced breastfeeding consultants and midwife, in order to follow the Norwegian guideline of 6 months exclusive breastfeeding and partial breastfeeding for a year.
15909044|NCT03580057|Behavioral|Diet and weight loss intervention|12-week program of dietary behavior modification treatment (LEVA-method by Bertz et al. Am J Clin Nutr 2012;96:698), leading to 6 kg weight loss (0.5 kg per week) and a healthier diet (less sugar, snacks, full fat products, more vegetables and fruit, smaller portion sizes). Weight is monitored by phone contact every second week. After 12 weeks, the women are followed up by e-mail contact for 9 additional months.
15909047|NCT03580031|Drug|hCG|A booster dose (10,000 IU of hCG) was given IM 48 hours after first triggering dose
15909048|NCT03580031|Drug|Saline Solution|2 ml of normal saline will be injected 48 hours after first triggering dose
15909049|NCT03580018|Drug|Tranexamic Acid Powder|Ten mL of Tranexamic Acid(100 mg/mL) was injected into the joint at the end of the operation.
15909050|NCT03580018|Procedure|Post-anterior cruciate ligament reconstruction (ACLR)|Post-anterior cruciate ligament reconstruction (ACLR)
15909051|NCT03580005|Drug|methylphenidate HCl ERCT|methylphenidate HCl ERCT
15909052|NCT03580005|Drug|Placebo|Placebo to Match Quillichew ERCT
15909053|NCT03579992|Behavioral|60-min isometric MyCI training|EMG-controlled in-lab training with arm restrained for 60 minutes per session
15909054|NCT03579992|Behavioral|90-min isometric MyCI training|EMG-controlled in-lab training with arm restrained for 90 minutes per session
15909055|NCT03579992|Behavioral|90-min movement MyCI training|EMG-controlled in-lab training without restraint for 90 minutes per session
15909056|NCT03579979|Drug|Methylene Blue|Subcutaneous injection of injection point at the periphery of the areola or tumor, injecting 1% methylene blue 0.5ml at each point, a total of 2-3 points.
15909057|NCT03579979|Drug|Indocyanine Green|Within 5 minutes after MB injection, 2.5mg/ml ICG 0.5ml was injected at each point, a total of 2-3 points. Methylene blue and ICG injection points do not coincide
15909058|NCT03579966|Drug|Amifampridine Phosphate|tablets equivalent to 10mg amifampridine, titrated to an efficacious and tolerable dose, 3 to 4 times a day
15909059|NCT03579953|Device|Real cTBS|This will be delivered with the Magventure Magpro system; 3600 pulses with the active sham coil (double blinded using the USB key).
15909060|NCT03579953|Device|Sham cTBS|This will be delivered with the sham Magventure Magpro system; 3600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.
15909061|NCT03579940|Drug|Lasmiditan|Administered orally.
15909062|NCT03579940|Drug|Placebo|Administered orally.
15909063|NCT03579927|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo ASCT
15909064|NCT03579927|Drug|Carmustine|Given IV
15909065|NCT03579927|Drug|Cytarabine|Given IV
15909066|NCT03579927|Drug|Etoposide|Given IV
15909067|NCT03579927|Biological|Filgrastim|Given SC
15909068|NCT03579927|Drug|Melphalan|Given IV
15909069|NCT03579927|Biological|Rituximab|Given IV
15909070|NCT03579927|Biological|Umbilical Cord Blood-derived Natural Killer Cells|Given CAR.CD19-CD28-zeta-2A-iCasp9-IL15-transduced CB-NK cells IV
15909071|NCT03579914|Drug|intravenous Placebo|Patients receive intravenous Placebo (saline) injection
15909072|NCT03579914|Drug|Metoprolol Injectable Product|Patients receive intravenous Metoprolol injection
15909073|NCT03579914|Device|Romote Ischemic Post-Conditioning (RIPC)|Patients receive RIPC treatment
15909074|NCT03579914|Combination Product|Metoprolol & RIPC|Patients receive Metoprolol & RIPC treatment
15909075|NCT03579901|Device|Silicone gel-filled breast implants - Motiva Implants® Investigational breast implants|Breast augmentation
15909076|NCT03579888|Biological|Autologous CD19-CD8-CD28-CD3zeta-CAR-mbIL15-HER1t T Cells|Given IV
15909077|NCT03579888|Drug|Cyclophosphamide|Given IV
15909078|NCT03579888|Drug|Fludarabine|Given IV
15909079|NCT03579875|Drug|Total Body Irradiation (TBI) (Plan 1)|300 cGy with thymic shielding on day -6
15909083|NCT03579875|Device|Donor mobilized PBSC infusion|T cell receptor alpha/beta depletion (α/β TCD) peripheral blood stem cell (PBSC) transplantation on day 0
15909084|NCT03579875|Drug|G-CSF|Initiate G-CSF 5mcg/kg per day IV on day +1 (continue until ANC >2.5 x 10^9/L for 3 consecutive days)
15909085|NCT03579875|Drug|Cyclophosphamide (CY) (Plan 2)|5 mg/kg IV daily on days -5, -4, -3, and -2
15909086|NCT03579875|Drug|Rituximab|200 mg/m2 IV once on day -1
15909087|NCT03579875|Drug|Busulfan|Busulfan 0.6 mg/kg if > 4 years old and/or >12 kg (0.8 mg/kg IV if ≤ 4 years old and/or ≤ 12 kg) is given IV over 2 hours every 12 hours for 2 days.
15909088|NCT03579862|Other|Blood Draw|
15909089|NCT03579849|Diagnostic Test|Pulmonary tomoscintigraphy|The included patients will benefit from pulmonary tomoscintigraphy within 24 hours after the diagnosis of pulmonary embolism. Each tomoscintigraphy will be interpreted blindly by 3 nuclear physicians. Each of the 20 lung segments will be interpreted as normoperfused or hypoperfused.
15909090|NCT03579836|Drug|BEY1107|Take orally with water once a day on a 3-weeks-on (21 days) continuously and 1-week-off (7 days) schedule.
15909091|NCT03579836|Combination Product|Gemcitabine|Administer 1,000 mg/m2 of Gemcitabine intravenously for 30 minutes on Day 1, 8, 15 and 1-week-off (7days) schedule.
15909092|NCT03579823|Drug|Adalimumab 100 MG/ML [Humira]|prefilled syringe at a concentration of 100MG/ML and delivering 40MG of adalimumab, as a single dose on day 1 day 1
15909093|NCT03579823|Drug|AVT02 100MG/ML|prefilled syringe at a concentration of 100MG/ML delivering 40MG of AVT02, as a single dose on day 1 day 1
15909094|NCT03579810|Other|Investigational|"The educational intervention helped to increase the knowledge of attitudes, and habits of healthy lifestyle in children, parents and teachers and it was based on health promotion models and social cognitive theory, to be articulated with the Institutional Educational Project through the pedagogical component that integrates three areas, physical activity, healthy eating, and the knowledge of the body and the heart with the dynamics of the educative community.
~The program covered self-care of the body and heart, healthy diet, and physical activity"
15909095|NCT03579810|Other|Control|The control group did not receive an educational intervention in areas of physical activity, healthy eating, and the knowledge of the body and the heart. Instead, children received the standard curriculum in health and physical activity of the national Ministry of Education.
15909096|NCT03579797|Behavioral|Screening, referral, follow-up and health management|Field screening, remote diagnosis, comprehensive assessment, referral, and eye health management of diabetics were the main study processes. The community health service centers (CHSC) are responsible for the field screening. The designated medical institutions (DMI) of each district are responsible for the remote diagnosis and comprehensive assessment of diabetic eye diseases, especially diabetic retinopathy (DR), based on comprehensive evaluation through the remote reading system (RRS) and Shanghai eye health information service system (SEHISS). The staff of CHSC urged the referral objects promptly for further diagnosis and treatment in DMI. According to the diagnosis after clinically confirmed, all the study participants will be recommended appropriate eye health management.
15909097|NCT03579784|Drug|Paclitaxel|Paclitaxel 80 mg/m2 mg iv on D1, D8, D15 Every 4 weeks
15909098|NCT03579784|Drug|Olaparib|Olaparib 150mg bid on D1-28 Every 4 weeks
15909099|NCT03579784|Drug|Durvalumab|Durvalumab 1.5 g iv on D1 Every 4 weeks
15909100|NCT03579771|Drug|Cisplatin|Given IV
15909101|NCT03579771|Drug|Gemcitabine|Given IV
15909102|NCT03579771|Drug|Nab-paclitaxel|Given IV
15909103|NCT03579758|Drug|Capecitabine|Given PO
15909104|NCT03579758|Drug|Cisplatin|Given IV
15909105|NCT03579758|Drug|Gemcitabine|Given IV
15909106|NCT03579745|Procedure|Lingual orthodontics|A coil spring will be attached from the lever arm to the first molar tube
15909107|NCT03579732|Drug|Aspirin (Acetylsalicylic Acid, BAYE4465)|Low dose of aspirin, i.e. < 150 mg daily
15909108|NCT03579732|Other|No drug|Non-consumers
15909109|NCT03579719|Drug|Balovaptan|"In Period 1, balovaptan was administered orally once daily (qd) on Days 1 to 10.
~In Period 2, balovaptan was administered qd on Days 6 to 20."
15909110|NCT03579719|Drug|Itraconazole|In Period 2, 200 mg itraconzole was administered bid for 4 days and qd on Days 5-20, approximately 12 hours apart. On Days 6-20, 200 mg itraconazole was administered qd.
15909111|NCT03579706|Behavioral|Cognitive Anxiety Sensitivity Treatment|The Cognitive Anxiety Sensitivity Treatment is a computerized treatment that is a combination of psychoeducation plus interoceptive exposure for anxiety sensitivity (AS). The psychoeducational component will focus on the nature of stress and its effect on the body. Interoceptive exposure (IE) exercises, designed to correct the conditioned fear to these bodily sensations, will be explained and practiced.
15909112|NCT03579706|Behavioral|Physical Health Education Training|The Physical Health Education Training is a computerized active placebo matched in time and structure to CAST that includes information about general health and wellness (e.g. diet, exercise etc.).
15909113|NCT03579693|Dietary Supplement|CoQ10|CoQ10 tablet
15909114|NCT03579693|Dietary Supplement|Nicotinamide riboside|NR tablet
15909115|NCT03579693|Dietary Supplement|Placebo|Sugar pill designed to mimic coQ10 and NR
15909116|NCT03579680|Behavioral|cRCT ADT order restriction (Or)|Order restrictions (Or) operate as an organizational constraint, widely perceived as a forcing function giving providers little leeway to exercise judgment but has a strong evidence-base for changing provider behavior.
15909117|NCT03579680|Behavioral|cRCT Provider script (Sc)|The provider script (Sc) is a communication aid to be used and documented as an accountable justification in the electronic medical record. This strategy also has a strong evidence-base for changing provider behavior.
15909119|NCT03579654|Biological|Proscavax|Proscavax is a prostate cancer vaccine which combines the prostate antigen PSA with immune stimulatory cytokines (IL-2 and GM-CSF).
15909120|NCT03579641|Device|HeartLogic Sensors|HeartLogic Sensors
15909264|NCT03578484|Diagnostic Test|Aesthetic assessment 3D breast scanning|Vectra TM - Canfield Inc breast scan. 3D digital photography scan.
15909121|NCT03579628|Drug|AsiDNA|"All patients will receive a loading dose of AsiDNA iv infusion (D1, D2, D3) followed by weekly iv administrations.
~At cycle 1: Part B1: Carboplatin will be administered by a 1 hour IV infusion at D8, 1 hour after the end of AsiDNA infusion. Part B2: Carboplatin will be administered by a 1 hour IV infusion at D8, 1 hour after the end of AsiDNA infusion and Paclitaxel will be administered by a 1 hour IV infusion at D8, D15, D22 or 1 hour after the end of AsiDNA infusion for weekly administrations.
~At each other cycle: AsiDNA will be administered on a weekly basis. Part B1: Carboplatin will be administered by a 1 hour IV infusion at D1, 1 hour after the end of AsiDNA infusion. Part B2; Carboplatin will be administered by a 1 hour IV infusion at D1, 1 hour after the end of AsiDNA infusion and Paclitaxel will be administered on a weekly basis by a 1 hour IV infusion.
~Patients will continue study treatment until disease progression, unacceptable toxicity or patient's refusal to continue."
15909122|NCT03579615|Device|FIASP + closed loop device|Participants will be advised to change their usual insulin to the corresponding study visit insulin formulation, 24 hours prior to admission. (For example; if the participant is on insulin aspart, this will be changed to faster-acting aspart 24-hour prior to the admission for closed loop with faster-acting aspart and vice versa).
15909123|NCT03579615|Device|Insulin aspart (standard of care insulin) + closed loop device|Participants will be advised to maintain their usual insulin 24 hours prior to admission.
15909124|NCT03579602|Drug|tozuleristide|Tozuleristide will be administered at least 1 hour and no more than 36 hours prior to planned surgical excision of their tumor.
15909125|NCT03579602|Device|Canvas System|All subjects enrolled in the study will have their tissue imaged with the Canvas System.
15909126|NCT03579589|Drug|Sugammadex vs Neostigmine|Patients will be randomized into either Sugammadex or Neostigmine neuromuscular blockade reversal.
15909127|NCT03579576|Drug|sofosbuvir 400 mg/velpatasvir 100 mg (SOF/VEL) orally once daily for 12 weeks with or without weight-based ribavirin.|Direct Acting anti-HCV drugs given to all HCV infected participants at baseline.Those with Co-infections like HIV and or HBV will be given treatment as per national guidelines.
15909128|NCT03579563|Other|Audiologist-based fitting|Hearing aids will be fitted by audiologists using established procedures.
15909129|NCT03579563|Other|Over-the-counter fitting|In this group, pre-configured Hearing aids will be provided to subjects. Subjects will take the full initiative and responsibility for learning and using hearing aids.
15909130|NCT03579563|Other|Hybrid fitting|Audiology professionals provide streamlined services to fit pre-configured amplification devices.
15909131|NCT03579550|Procedure|office hysteroscopic metroplasty intervention arm|One group will be performed hysteroscopic metroplasty Second group will be undertaken to six months spontaneous coitus and three cycles of COH/IUI
15909132|NCT03579537|Other|Intradyalisis without exercise programe|patients on hemodialysis are evaluated with all the variables at first (T1) and without intervening in the treatment for 3 months they are evaluated again (T2).
15909133|NCT03579537|Other|Intradyalisis with exercise programe|After 3 first month without intervention and also during the time of hemodialysis, the patients star the exercise programe, the first part of the session, an exercise was carried out for cardiovascular work (pedaling on ergometer) and muscle toning, with special attention to the muscular development of the lower limbs (exercises with elastic bands and / or weighted ankles). The session increased in duration and intensity as the physical action program progressed throughout the duration of the permitted period (3 months) and always attending to the individual needs of each subject. In addition, each of the participants will be given a series of recommendations of exercise practice to be carried out during non-hemodialysis days, in order to complement the work done during the sessions.3 month later the investigator evaluated all the variable again (T3)
15909134|NCT03579524|Procedure|Erector Spinae Plane Block|At lateral decubitus with the operation site up, the vertebrae will be counted from cephalad to caudal direction until reaching T5 spinous process as the first palpable spinous process is C7. The ultrasound probe will be placed vertically 3 cm lateral to the T5 spinous process. Three muscles will be identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. The needle will be introduced from superior to inferior direction in-plane until the tip lay deep to erector spinae muscle. 0.5: 1 mL of non-active fluid will be injected to confirm correct needle tip position by visualizing spread under erector spinae muscle. A total of 20 mL of 0.25% bupivacaine will be injected next.
15909135|NCT03579524|Procedure|Serratus Anterior Plane Block|At supine position with the arm abducted, the ribs will be counted in the mid-axillary line from downward upwards until the 5th ribs. The linear probe will be placed horizontally then three muscles will be identified: latissimus dorsi (superficial and posterior), teres major (superior) and serratus muscles (deep and inferior). The needle will be inserted in-plane with respect to the ultrasound probe from supero-anterior to posteroinferior. 0.5: 1 mL of non-active fluid will be injected to confirm correct needle tip position by visualizing spread over serratus anterior muscles, then a total 20 ml of bupivacaine 0.25% will be injected.
15909136|NCT03579511|Procedure|External Pop-out|The original techniques of fetal head extraction entail the introduction of the obstetricians' hands or other instruments into the LUS. This puts the LUS at risk of damage and incision extensions with its consequences of increased blood loss, increased operative time,infection adhesions and blood transfusion.To the available, the generated good quality evidence bases practice in CS is anticipated to decrease such morbidities
15909137|NCT03579472|Drug|Bintrafusp Alfa|Given IV
15909138|NCT03579472|Drug|Eribulin Mesylate|Given IV
15909139|NCT03579459|Biological|Clostridium difficile vaccine|Toxoid based Clostridium difficile vaccine
15909140|NCT03579459|Biological|placebo|Normal saline solution
15909141|NCT03579446|Drug|Hydrocodone|Given PO
15909142|NCT03579446|Drug|Hydromorphone|Given PO
15909143|NCT03579446|Drug|Hydromorphone Hydrochloride|Given PO
15909144|NCT03579446|Drug|Levorphanol|Given PO
15909145|NCT03579446|Drug|Morphine|Given PO
15909146|NCT03579446|Drug|Morphine Sulfate|Given PO
15909147|NCT03579446|Drug|Oxycodone|Given PO
15909148|NCT03579446|Drug|Oxymorphone|Given PO
15909149|NCT03579446|Drug|Oxymorphone Hydrochloride|Given PO
15909150|NCT03579446|Other|Questionnaire Administration|Ancillary studies
15909265|NCT03578471|Device|Hearing Aid without NR and BF|Each participant will be fitted with the Noise Reduction (NR) and Beamforming (BF) disabled. Disabled means that no sound processing algorithm that removes noise from the speech signal is active.
15909151|NCT03579433|Device|ORA with VerifEye+|Intraoperative device that measures total corneal astigmatism in the aphakic condition and is used for the selection of IOL power. In the pseudophakic condition, ORA provides guidance for the alignment of the toric axis mark.
15909152|NCT03579433|Other|Alcon Barrett Toric Calculator|Web-based software application that utilizes an algorithm (Barrett Formula) to estimate the amount of post-operative corneal astigmatism in order to optimize IOL model selection and axis placement, with interoperative axis alignment done manually.
15909153|NCT03579433|Device|Acrysof® IQ Toric IOL|Intraocular lens implanted as a replacement for the cataractous lens during cataract surgery (Model SN6AT3, SN6AT4, Model SN6AT5, Model SN6AT6)
15909154|NCT03579420|Behavioral|Brief lifestyle program|3-session program for modification of lifestyle habits (exercise and diet)
15909155|NCT03579420|Behavioral|Conventional lifestyle program|6-session program for modification of lifestyle habits (exercise and diet)
15909156|NCT03579407|Procedure|BMA cell therapy injection|The bone marrow aspirate will be injected into the affected knee joint.
15909157|NCT03579394|Procedure|Retarded IDS (Interval Debulking Surgery)|"Patient will receive 6 courses of i.v carboplatine and paclitaxel every 3 weeks followed by IDS (Interval Debulking Surgery) within 6 weeks from C6D1. After surgery patient will undergo 2 more courses of carboplatine and paclitaxel chemotherapy
~Treatment accepted :
~Paclitaxel and carboplatin could will be administred according to the site practice and Saint-Paul-de-Vence recommendation (Joly et al, 2017):
~paclitaxel 175 mg/m² + carboplatin AUC 5-6, D1=D21 or
~paclitaxel 80 mg/m² at J1-J8-J15 + carboplatin AUC 5-6, D1=D21 or
~paclitaxel 60 mg/m² D1-D8-D15 + carboplatin AUC2 D1-D8-D15, D1= D21
~Adjuvant therapy and maintenance (optional)according to national recommendations (Saint Paul de Vence)"
15909158|NCT03579394|Procedure|Standard IDS (Interval Debulking Surgery)|"Patient will receive 3 courses of i.v carboplatine and paclitaxel every 3 weeks followed by IDS (Interval Debulking Surgery) within 6 weeks from C3D1. After surgery patient will undergo 5 more courses of carboplatine and paclitaxel chemotherapy.
~Treatment accepted :
~Paclitaxel and carboplatin could will be administred according to the site practice and Saint-Paul-de-Vence recommendation (Joly et al, 2017):
~paclitaxel 175 mg/m² + carboplatin AUC 5-6, D1=D21 or
~paclitaxel 80 mg/m² at J1-J8-J15 + carboplatin AUC 5-6, D1=D21 or
~paclitaxel 60 mg/m² D1-D8-D15 + carboplatin AUC2 D1-D8-D15, D1= D21
~Adjuvant therapy and maintenance (optional)according to national recommendations (Saint Paul de Vence)"
15909159|NCT03579368|Device|Symfony implantation|Bilateral Symfony IOL Implantation
15909160|NCT03579355|Behavioral|DFND Program|The DFND program consisted primarily of a 10-session curriculum, each session lasting about an hour. The curriculum was comprehensive and incorporated information about tobacco and its adverse health effects, social influences, and social competence skills.
15909161|NCT03579342|Behavioral|App-technology and active coaching to improve lifestyles behaviors|Access to the smartphone-app during 12 weeks. A personal health goal related to for example diet, physical activity or stress habits, is set together with a heath coach. Participants receive continuous coaching every 4 weeks during follow-up.
15909162|NCT03579342|Behavioral|App-technology to improve lifestyle behaviors|Access to the smartphone-app during 12 weeks. A personal health goal related to for example diet, physical activity or stress habits, is set together with a heath coach. Participants receive continuous coaching every 4 weeks during follow-up.
15909163|NCT03579329|Procedure|Total Knee Arthroplasty|Effect of Total Knee Arthroplasty on Sarcopenia in Patients with Osteoarthritis in the Knee
15909164|NCT03579316|Drug|Adavosertib|Given PO
15909165|NCT03579316|Drug|Olaparib|Given PO
15909166|NCT03579303|Other|Homoeopathic Remedies|comparison between homoeopathic treatment and integrated approach of homoeopathy and yoga in menstrual disorders of females with PCOS
15909167|NCT03579290|Behavioral|CBT4CBT program|"The 'CBT for CBT' program is modeled closely on our NIDA-published CBT manual. Seven core skill modules will cover the following topics, which correspond to the major session topics in the manual:
~Understanding and changing patterns of drug use,
~Coping with craving,
~Substance refusal skills,
~Seemingly irrelevant decisions,
~Planning for emergencies, and
~Problem-solving skills.
~Staying Safe"
15909168|NCT03579277|Procedure|Radial Forearm Free Flap|Subjects in this arm will undergo a radial forearm free flap.
15909169|NCT03579277|Procedure|Ulnar Forearm Free Flap|Subjects in this arm will undergo an ulnar forearm free flap.
15909170|NCT03579264|Behavioral|My Viva Plan|Use of the online platform, My Viva Plan, to support health and wellness.
15909171|NCT03579251|Behavioral|Black Men's Care|12 weeks of behavioral intervention, including an in-person session and two-way SMS, to re-engage in HIV care HIV-positive Black men who have fallen out of care
15909172|NCT03579238|Procedure|CV4|The occiput of a supine patient is held such that flexion motion is inhibited and extension motion is reinforced.
15909173|NCT03579238|Procedure|touching|the clinician allows the participant's head to rest quietly upon his open palms on a table.
15909174|NCT03579225|Device|MATRx plus test|The MATRx plus is a home-based test that allows the healthcare provider to determine if a patient with obstructive sleep apnea will benefit from oral appliance therapy. Prior to the test, a dentist fits the patient with dental trays and measures the patient's comfortable jaw range of motion. The trays are connected to a mandibular positioner. During sleep, the device collects airflow from a nasal cannula and blood oxygen saturation from a pulse oximeter. These signals are used by the device software to control the mandibular positioner and protrude the mandible. During the test, the device moves the lower jaw within the patient's range of motion to predict if the patient is likely to benefit from oral appliance therapy and, if so, the appropriate amount of protrusion. Additional study nights may be required if the data from either of the first two nights are insufficient or if a more precise determination of the amount of jaw protrusion that provided a therapeutic benefit can be made.
15909175|NCT03579212|Device|Y-STRUT® (Hyprevention, Pessac, France)|The studied medical device consists of two components implanted in the proximal femur, combined with bone cement.
15909176|NCT03579199|Device|exploration of abdominal cavity and liver using a NIR/ICG camera|exploration of abdominal cavity and liver using a NIR/ICG camera
15909177|NCT03579186|Device|OKS|Optokinetic stimulation
15909178|NCT03579173|Diagnostic Test|Infant PFT|Assessed through the raised volume rapid thoracoabdominal compression technique and plethysmography
15909339|NCT03577912|Procedure|TAP block administered by Surgery|TAP block administered by Surgery
15909340|NCT03577912|Procedure|TAP block administered by Anesthesia|TAP block administered by Anesthesia
15909179|NCT03579173|Diagnostic Test|Lung Clearance Index|The Lung Clearance Index is derived from the Multiple Breath Washout test. It is the cumulative exhaled volume (the volume of gas needed to wash out resident gas mixture out of the lungs) divided by the FRC. The FRC is the amount of air left in the lungs after normal exhalation.
15909180|NCT03579173|Diagnostic Test|Passive tidal breathing|During quiet sleep, tidal breathing flow-volume curves are obtained. The tPEF/tE is calculated by taking the time it takes to reach peak expiratory flow divided by the total peak expiratory time.
15909181|NCT03579160|Drug|0.25% timolol gel with full-thickness skin grafts|Timolol 0.25% gel will be applied to wound bed immediately after surgery before dressing is applied.
15909182|NCT03579160|Other|Vaseline dressing|Vaseline will be applied to wound bed immediately after surgery before dressing is applied.
15909183|NCT03579147|Device|Treatment with BTL EMSCULPT device|The treatment administration phase will consist of four (4) treatments, delivered twice a week. The applicator will be applied over the buttock area. Visible contractions will be induced by the device.
15909184|NCT03579134|Device|partial overlay denture|removable appliance similar to a removable partial denture but with overlay occluslal rests covering the full occlusal surface of the remaining posterior teeth
15909185|NCT03579134|Other|fixed temporary crowns|fixed crowns made from temporary material placed to the newly altered vertical dimension
15909186|NCT03579121|Other|Pharmacogenomic (PGx)|Administer a pharmacogenomics test (buccal swab) during the pre-operative setting
15909187|NCT03579121|Other|Review results|Pharmacogenomic (PGx) results reviewed by the clinicians during their treatment and the results may guide clinical decisions.
15909188|NCT03579108|Other|Retrospective Chart Review|Chart review
15909189|NCT03579095|Dietary Supplement|Cereboost|200mg Cereboost and Maltodextrin capsules
15909190|NCT03579095|Dietary Supplement|Placebo|200mg Maltodextrin capsules
15909191|NCT03579082|Drug|Decitabine|Given ivgtt
15909192|NCT03579069|Other|Ductus venosus Doppler|Ductus venosus Doppler
15909193|NCT03579043|Other|Nutritive Sweetener|Participants will receive twelve, 12-ounce cans of a beverage that represents their assigned condition. Participants will be instructed to drink their assigned beverages Tuesday through Thursday, and to consume one beverage at 12pm, the second at 3pm, and the third at 6pm. Participants will be instructed that the beverages need to be consumed within +/- 30 minutes of the instructed time. Participants will be instructed that any other beverage consumed on Tuesday through Thursday should be water.
15909194|NCT03579043|Other|Non-Nutritive Sweetener|Participants will receive twelve, 12-ounce cans of a beverage that represents their assigned condition. Participants will be instructed to drink their assigned beverages Tuesday through Thursday, and to consume one beverage at 12pm, the second at 3pm, and the third at 6pm. Participants will be instructed that the beverages need to be consumed within +/- 30 minutes of the instructed time. Participants will be instructed that any other beverage consumed on Tuesday through Thursday should be water.
15909195|NCT03579043|Other|Carbonated Water|Participants will receive twelve, 12-ounce cans of a beverage that represents their assigned condition. Participants will be instructed to drink their assigned beverages Tuesday through Thursday, and to consume one beverage at 12pm, the second at 3pm, and the third at 6pm. Participants will be instructed that the beverages need to be consumed within +/- 30 minutes of the instructed time. Participants will be instructed that any other beverage consumed on Tuesday through Thursday should be water.
15909196|NCT03579030|Drug|Placebo oral capsule|Placebo capsule matched to an RTA 1701 capsule
15909197|NCT03579030|Drug|RTA 1701 capsules|Capsule containing RTA 1701, multiple dosages
15909198|NCT03579017|Diagnostic Test|ECAS-N|All participants included will be tested with the ECAS-N
15909199|NCT03579017|Diagnostic Test|MoCA|All included patients With ALS will be tested With the MoCA
15909200|NCT03579004|Drug|Paclitaxel|Paclitaxel is used in two cycles of neoadjuvant chemotherapy and concomitant chemoradiotherapy
15909201|NCT03579004|Drug|Cisplatin|Cisplatin is used in two cycles of neoadjuvant chemotherapy and concomitant chemoradiotherapy
15909202|NCT03579004|Drug|Fluorouracil|Fluorouracil is used in two cycles of neoadjuvant chemotherapy
15909203|NCT03579004|Radiation|chemoradiotherapy|Distant 3D radiotherapy, single dose 2 Gray (Gy), total dose 44Gy.
15909204|NCT03579004|Procedure|Ivor Lewis esophagogastrectomy|Open Ivor Lewis esophagogastrectomy
15909205|NCT03578991|Device|Smart pillbox|The smart electronic pillbox will monitor adherence to pharmacological treatment by means of registering time of medications intake. It will incorporate visual and auditory reminders for taking medications (all of them, being or not being inside the dispenser such as insulin or eye drops). The dispenser will also have sensors and alarms to ensure the proper preservation of the medicines contained. The dispenser will be recharged weekly by a trained pharmacist. Each dispenser will be identified unequivocally with one user, and it will be interconnected with a mobile application (app).
15909206|NCT03578991|Other|Interactive digital platform|The digital interactive platform will allow communication between patients and caregivers and healthcare professionals. Its aims are to provide feedback and guidelines on treatment adherence and also, on how to better optimize treatment on cardiovascular risk factors. The platform will inform about medication dosages and intake schedule, healthy lifestyles related to diabetes, occurrence of adverse events, and it will also monitor patients' glycemic control. In this sense, several alarms are programmed to warn caregivers or even healthcare professionals when the patient has hyperglycemia or hypoglycaemia. The platform will provide too guidelines on how to treat hypo or hyperglycemia as well as most common adverse events, and it will describe reasons to have suffered it.
15909207|NCT03578978|Other|No intervention|No intervention will be given to study subjects. Only blood will be obtained from study subjects.
15909208|NCT03578965|Drug|Cefazolin|-If patient has a penicillin allergy then clindamycin will be used. Prophylactic antibiotics should be administered prior to skin incision
15909209|NCT03578952|Device|TAVR with Evolut R valve|TAVR with Evolut R valve
15909210|NCT03578939|Procedure|Biopsy EUS guided|NGS Sequencing on Biopsy samples
15909211|NCT03578926|Device|fanfilcon A toric lens|contact lens
15909212|NCT03578926|Device|senofilcon A toric lens|contact lens
15909341|NCT03577899|Biological|0.5 mg Conbercept Intravitreal Injection|Subjects received 0.5 mg conbercept intravitreal injection at Day 1, Week 4 and Week 8 (three injection loading dose), and treated every eight weeks thereafter (0.5 mg, q8w) for a total of 92 weeks treatment in the study eye.
15909213|NCT03578913|Other|PEEK crown|The main concern of dental implants is their lack of elasticity, therefore with the use of PFM, all ceramic or zirconia crowns; the load is directly transferred to bone. That is why up till now researchers are in quest of different materials to enhance soft and hard tissue reaction around implant supported restorations. Recently the use of PEEK as a final restoration on dental implants has wide acceptance, due to its excellent biocompatibility and exceptional physical and chemical properties regarding toughness, hardness and elasticity. In term of load cushioning capacity of the prosthetic elements, PEEK has a comparable modulus of elasticity (4GPa) to that of bone (4.2GPa). Thus, the bone could allow bone stimulation favoring its remodeling without overloading.
15909214|NCT03578913|Other|PFM Crown|Although metal free restorations are gained popularity recently, PFM restorations, whether they are tooth-supported or implant-supported are still considered as the gold standard due to their excellent biocompatibility, consistent esthetics, superior strength, and marginal adaptation.2 PFM restorations are also considered durable and long-lasting
15909215|NCT03578900|Drug|Xeros|
15909216|NCT03578900|Drug|Citric Acid based Mouthwash|
15909217|NCT03578887|Behavioral|Behavioral Weight Loss Program|Behavioral Weight Loss Program is a modified version of the Diabetes Prevention Program (DPP).
15909218|NCT03578887|Procedure|Roux-en-Y Gastric Bypass or Sleeve Gastrectomy|Subjects undergoing Roux-en-Y Gastric Bypass or Sleeve Gastrectomy with their own surgical team
15909219|NCT03578874|Drug|Sorafenib|PO
15909220|NCT03578874|Drug|Capecitabine|PO
15909221|NCT03578874|Drug|Oxaliplatin|IV
15909222|NCT03578861|Other|Dementia related mobility and counseling|"The DESKK mobility program is based on the already existing day structure of the RC facility with two slots a day for physical activation activities (1 ½ hours forenoon and 1 ½ hours afternoon). The program structures these activities based on specific developed exercises, which are focused on the individual mobility level of every PwD and his/her mobility level.
~The DESKK counseling program is an effort to structure and systemize counseling processes focused on the respite care setting by different documents and assessments."
15909223|NCT03578848|Device|uAOBP|For the uAOBP and CBP, the measurements will be conducted in a quiet room without the presence of clinical personnel. Patients will be seated in a quiet room without talking and taken as an average of 3 measurements with an automated device (HEM-907, Omron Healthcare, Lake Forest, IL) that has been preset to wait 5 minutes before measurements. Simultaneously, the central BP will be measured in the other upper arm. (WatchBP Office Central; Microlife AG, Widnau, Switzerland). The determination of the right or left upper arm for uAOBP or central BP will be made in a random order by computer generated random codes before the enrollment.
15909224|NCT03578848|Device|Home BP|As for the home BP measurements, a validated device (WatchBP Home; Microlife AG, Widnau, Switzerland) will be provided for all subjects allocated to the home BP arm to measure their BP at home. Subjects are requested to take BP in the morning (within 2 hours after awakening) and afternoon before meals for 7 consecutive days before the scheduled clinical visits. BP in the first day of the measurements will be discarded and an average of home BP (all BP reading and BP in the morning and in the afternoon) will be generated and provided for clinicians to guide their treatment.
15909225|NCT03578848|Device|CBP|For the uAOBP and CBP, the measurements will be conducted in a quiet room without the presence of clinical personnel. Patients will be seated in a quiet room without talking and taken as an average of 3 measurements with an automated device (HEM-907, Omron Healthcare, Lake Forest, IL) that has been preset to wait 5 minutes before measurements. Simultaneously, the central BP will be measured in the other upper arm. (WatchBP Office Central; Microlife AG, Widnau, Switzerland). The determination of the right or left upper arm for uAOBP or central BP will be made in a random order by computer generated random codes before the enrollment.
15909226|NCT03578822|Drug|Recombinant human urokinase|Patients receive rhPro-UK 35mg,15mg of which is given as a bolus within 3min followed by dlivery of the remaining 20 mg as a constant infusion over a period of 30 min.
15909227|NCT03578822|Drug|Aspirin|Aspirin 300mg is taken orally at the beginning of thrombolysis.
15909228|NCT03578822|Drug|rhPro-UK simulation agent|Patients receive rhPro-UK simulation agent 35mg,15mg of which is given as a bolus within 3min followed by dlivery of the remaining 20 mg as a constant infusion over a period of 30 min.
15909229|NCT03578822|Drug|Aspirin simulation agent|Aspirin simulation agent 300mg is taken orally at the beginning of thrombolysis.
15909230|NCT03578809|Biological|MEDI6012|MEDI6012
15909231|NCT03578809|Other|Placebo|Placebo
15909232|NCT03578796|Diagnostic Test|ECAS-N|assessing ALS-specific cognitive impairment
15909233|NCT03578796|Diagnostic Test|MoCA|assessing cognitive impairment
15909234|NCT03578796|Diagnostic Test|CDR|assessing global cognitive impairment, as well as possible diagnosis- and Level of dementia
15909235|NCT03578796|Other|Questionnaire|Questions related to work situation and car driving
15909236|NCT03578783|Drug|Placebo|"For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration.
~Study subjects should leave at least 24 hours between each dosing."
15909237|NCT03578783|Drug|PSD502|"For each sexual encounter during the 4-week treatment period the study spray will be applied 5 minutes before intercourse and any excess will be wiped off prior to penetration.
~Study subjects should leave at least 24 hours between each dosing."
15909238|NCT03578770|Device|Hot Axios stent|Hot Axios stent
15909239|NCT03578757|Behavioral|21-day residential program|"Both groups will benefit of a 21-day residential program at the thermal spa resort combining corrections of eating disorders (and a negative energy balance of 500 kcal/day), physical activity (2h30 per day, minimum), thermal spa treatment (2h per day, minimum), and health education (1h30 per day, minimum: cooking, nutrition and physical activity classes…). Physical activity will be diverse (endurance, strength, circuit training) and personalized to the target of each participant.
~The intervention group will benefit from psychological interventions based on validated approaches of stress (3 x 1h30 per week). Participants will attend psychological sessions by group of less than 10 individuals. Individual meeting with the psychologist will occur at least twice: at the beginning of the residential program and at the end.
~After the spa residential program, participants will undergo a one-year at-home follow-up."
15909240|NCT03578744|Procedure|Conventional Flap surgery|After administering local anaesthetic a full thickness flap will be raised and reflected to expose the furcation defects. The furcation defects would then be debrided and the graft and membrane secured in position. Later the flap would be sutured back.
15909241|NCT03578731|Device|app|"The app is used to record the study parameters for a period of 90 days.
~The following measures are used for data collection:
~Interview during regular consultation with doctor
~Web-App for gathering doctors data
~Consilium Smartphone App for gathering patient data During the course of care, the patient enters in a regular manner symptoms and treatment side effects in the Smartphone app. A continuous capture of the symptoms and treatment side effect is provided. If no entry is made within 3 days the patient is prompted to enter the data via a push message.
~Well-being through a patient rating on a visual analog scale
~Registration of symptoms and treatment side effects is done through the app
~After completion of the study patients will be questioned according to:
~• Usability and usefulness of the Smartphone app"
15909242|NCT03578705|Device|"Electrical Impedance Myography unit or EIM"|
15909243|NCT03578679|Drug|Ivermectin Oral Product|treatment of pediculosis (head lice)
15909244|NCT03578666|Other|Massage|The intervention will be applied to both legs to a constant distal to proximal stroking rhythm. Firstly, participants will be lying in a prone position for 22 min: 1 min on the sole of the foot, 1 min on the Achilles tendon, 1 min on the soleus muscle, 3 min on the triceps muscle, 4 min on the hamstring muscles, 30 s tapotement from the sole of the foot to the hamstrings and 30 s superficial effleurage from the sole of the foot to the hamstrings. Then they will assume a supine position for 18 min: 1 min on the sole of the foot, 3 min on the tibialis anterior and peroneus lateralis muscles and 4 min in the quadriceps, adductors and lata muscles, 30 s tapotement from the sole of the foot to the hamstrings and 30 s superficial effleurage from the sole of the foot to the hamstrings.
15909245|NCT03578666|Other|Cold water immersion|The cold water immersion group immersed their lower limbs (ensuring that the iliac crests were fully immersed) in an ice bath filled with cooled water for 10 min. The water was maintained at a mean temperature of 10 degrees (±0.5°) by the addition of ice.
15909246|NCT03578653|Behavioral|Merging Yoga and Occupational Therapy for Parkinson disease|The group occupational therapy portion focuses on lecture, group discussion, and activities to reduce fall risk. The yoga program is part of an ongoing community yoga program specifically designed for people with Parkinson disease.
15909247|NCT03578640|Drug|Elbasvir, Grazoprevir 50-100Mg Oral Tablet|Daily, fixed-dose combination of Elbasvir 50 mg and Grazoprevir 100 mg given in a single oral tablet for 8 weeks.
15909248|NCT03578627|Behavioral|BioBehavioral Intervention|Psychological (stress and quality of life), behavioral (health behaviors and compliance), and biologic (neuroendocrine and immune) factors, and pathways by which health outcomes (e.g. disease endpoints-recurrence, disease free interval) might be affected.
15909249|NCT03578614|Other|Physical Activity|"3 physical activity sessions are planned by week, 2 supervised and 1 non-supervised conducted over 6 months. On the first 2 months, the supervised sessions have 10 minutes of warm-up + 5 minutes active pause (balance, agility and coordinative exercises) + 15 minutes walking + 5 minutes active pause (resistance exercises - 1 series of 12 repetitions
~- 3 callisthenic exercises) + 15 minutes walking + 5 minutes flexibility (1 series of 10 seconds in 3 different postures). The aimed intensity in these first two months is 12/13. Between the 2nd and the 4th months, the duration of the walking period increases, as well as the intensity, RPE 13/14. Between the 4th and the 6th months, again the duration of the walking period increases, as well as the intensity, RPE 14/15. To measure the intensity level of the physical activity, the Borg Rating of Perceived Exertion (RPE) ranging from 6 (rest) to 20 (maximum effort) is used."
15909250|NCT03578601|Other|Thyroid surgery|Patient undergoing thyroid surgery
15909251|NCT03578588|Drug|Banapenem|Twelve healthy adult volunteers, half male and female, are enrolled and randomly assigned to three groups, B1, B2, and B3. The subjects in three groups receive three doses, 250 mg, 500 mg and 1000 mg. Each group of subjects receive single-dose test drug at different dosages in each period. The subjects are divided into two groups, C1 and C2, 12 subjects in each group, half males and half females. 250 mg group is performed first. After completion of observation and confirming that the drug can be safely tolerated, study on 500 mg group is then performed
15909252|NCT03578575|Drug|Danggui Buxue Tang|Danggui Buxue Tang is an extracted powder of traditional Chinese medicine formula.
15909253|NCT03578575|Drug|Placebo|Placebo is a very low dose Danggui Buxue Tang powder.
15909254|NCT03578562|Other|Targeted training intervention|An 8-week progressive homebased training intervention with supervised booster-sessions
15909255|NCT03578549|Device|Pulse Oximetry|Pulse Oximeter is being applied with a special holding tool to test the oximeter for its ability to measure pulpal blood flow, but no effect of the oximeter is being measured. Thus, to that degree the use is observational rather than interventional.
15909256|NCT03578536|Device|Recovery Rapids|This project utilizes a new gaming system technology called Recovery Rapids. The game is custom-made by Games That Move You, LLC and runs on an XBOX platform with motion input via a Kinect system.
15909257|NCT03578523|Other|3 Tesla multiparametric MR|Renal MRI Scan to assess blood flow, perfusion, oxygenation and microstructure (MR T1 relaxation time and diffusion). Each patient will have 3 renal MRI scans.
15909258|NCT03578523|Other|renal histopathology scoring|Blinded fibrosis scoring of renal histopathology (If biopsy performed for clinical indication)
15909259|NCT03578523|Biological|Blood and urine sampling|"Blood and urine sampling around scan sessions; this will include routine patient care biochemistry and haematology panel,
~urine protein and albumin measurements, stored plasma/serum/urine for subsequent analysis"
15909260|NCT03578523|Biological|Iohexol clearance test|Iohexol clearance to measure GFR within 1 week of the scan session
15909261|NCT03578510|Device|Hemocontrol hemodialysis|Each participating patient underwent one standard hemodialysis and one hemodialysis with Hemocontrol in random order, both 4 hours in total duration. The Hemocontrol system guides the patients' blood volume along a predefined ideal relative blood volume trajectory, by continuously adjusting ultrafiltration volume and dialysate sodium concentration.
15909262|NCT03578510|Device|Standard hemodialysis|Each participating patient underwent one standard hemodialysis and one hemodialysis with Hemocontrol in random order, both 4 hours in total duration. During standard hemodialysis, a constant ultrafiltration rate and dialysate conductivity was used.
15909263|NCT03578497|Drug|IL-1 receptor antagonist Anakinra|IL-1 receptor antagonist Anakinra is a recombinant, non-glycosylated form of the human IL-1Ra in a 100 mg/ 0.67 ml solution for subcutaneous injection. Standard dosage licensed by the FDA and European Medicines Agency (EMA) is 100 mg Anakinra daily. It is supplied in single use prefilled glass syringes with 27 gauge needles as a sterile, clear, colourless-to-white, preservative free solution for daily s.c. administration.
15909266|NCT03578471|Device|Hearing Aid with NR|Each participant will be fitted with the Noise Reduction (NR)(Sound Changing) program on the same hearing aid. Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The Noise Reduction is working spatially independent.
15909267|NCT03578471|Device|Hearing Aid with BF|Each participant will be fitted with a beam forming program on the same hearing aid. Beam forming (BF) principle is a sound processing algorithm to remove noise from certain directions to improve the speech intelligibility and comfort.
15909268|NCT03578458|Other|subjects will install a mobile app for use|novel mobile application
15909269|NCT03578445|Device|EUS-guided microbiopsy|Use of EUS-guided through-the-needle microbiopsy forceps for obtainment of tissue from the wall of the cystic lesion
15909270|NCT03578445|Diagnostic Test|Next Generation Sequencing|Prevalence of genetic mutations in known cancer-associated genes in the microbiopsy tissue examined using the Ion AmpliSeq Cancer Hotspot Panel v2 (Life Technologies, Carlsbad, USA). The multigene panel explores selected regions of 50 cancer-associated genes, among others KRAS, GNAS, CDKN2A and SMAD4 genes.
15909271|NCT03578432|Drug|Everolimus|Given PO
15909272|NCT03578432|Other|Laboratory Biomarker Analysis|Correlative studies
15909273|NCT03578432|Other|Survey Administration|Ancillary studies
15909274|NCT03578419|Device|Small-Volume Blood Collection Tubes|Small-volume vacuum (< 4 mL) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and serum blood collection tubes.
15909275|NCT03578419|Device|Standard-Volume Blood Collection Tubes|Standard-volume (≥ 4 mL) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and serum blood collection tubes.
15909276|NCT03578406|Drug|HPV E6-specific TCR-T cells|Patients were infused with HPV E6-specific TCR-T cells
15909278|NCT03578380|Procedure|Surgery|Lymphovenous anastomosis
15909279|NCT03578380|Other|Compression and drainage therapy|Treatment with compression stockings and manual drainage (massage therapy)
15909280|NCT03578367|Drug|Asciminib add-on|Asciminib 60 mg or 40 mg taken orally once daily in addition to Imatinib 400 mg taken orally once daily
15909281|NCT03578367|Drug|Imatinib|Imatinib 400 mg taken orally once daily
15909282|NCT03578367|Drug|Nilotinib|Nilotinib 300 mg taken orally twice daily (total daily dose of 600 mg)
15909283|NCT03578354|Drug|4-aminopyridine|an oral drug to be swallowed
15909284|NCT03578354|Drug|Atenolol|an oral drug to be swallowed
15909285|NCT03578354|Other|Placebo|a masked placebo to be swallowed
15909286|NCT03578341|Biological|Orally Colostrum|Group 1, Will receive colostrum 0.3 mL every 4 hours in the oropharyngeal mucosa, for 3 days.
15909287|NCT03578328|Procedure|targeted temperature management|Temperature control to targeted temperature (32-36C) after return of spontaneous circulation after cardiac arrest and resuscitation
15909288|NCT03578315|Device|HGM|To Study the Efficacy and safety of QSRL and PSNYL in the Treatment of target: A nonrandomized, controlled, split-face comparative study
15909289|NCT03578289|Behavioral|Telemental Health - CBT|The experimental group will received cognitive behavioral therapy (CBT) via TMH for 8 sessions.
15909290|NCT03578276|Drug|Pred-Gati-Brom|The combination drop therapy containing prednisolone acetate 1%, gatifloxacin 0.5%, and bromfenac 0.075%
15909291|NCT03578276|Drug|Prednisolone acetate 1% ophthalmic suspension|Steroidal anti-inflammatory
15909292|NCT03578276|Drug|Gatifloxacin Ophthalmic|Antibiotic
15909293|NCT03578276|Drug|Bromfenac 0.075% Oph Solution|Non-steroidal anti-inflammatory
15909294|NCT03578263|Drug|Carbetocin|Group (A): included 100 patients who received carbetocin 100 µg diluted in 10 ml normal saline and administered slowly (over 30-60 seconds) intravenously by anesthetist after the birth of the baby.
15909295|NCT03578263|Drug|oxytocin|Group (B): included 100 patients who received a combination of intraoperative oxytocin 5 I.U which was diluted in 10 ml normal saline and administered slowly over (30-60 seconds) intravenously by anesthetist and
15909296|NCT03578263|Drug|ergometrine|intramuscular ergometrine 0.2 mg.
15909297|NCT03578250|Other|Robotic Training|Upper extremity training on a robotic device with or without error augmentation force field.
15909298|NCT03578237|Device|Cryoneurolysis (active)|Mastectomy (subjects 1-18): Myoscience Iovera device: full cryo cycle. Mastectomy (subjects 19-end) and all other procedures: Epimed PainBlocker device: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with an active probe which results in a decrease in temperature
15909299|NCT03578237|Device|Sham cryoneurolysis procedure|"Mastectomy (subjects 1-18): Myoscience Iovera device: simulated full cryo cycle without administering gas to the probe.
~Mastectomy (subjects 19-end) and all other procedures: 3 cycles of 2-minute gas activation separated by 1-minute defrost periods with a SHAM probe that does not deliver gas to the tip or result in a drop in temperature"
15909300|NCT03578224|Procedure|Endoscopic Ultrasound-Guided Fine-Needle Aspiration (EUS-FNA)|Undergo EUS-FNA
15909301|NCT03578224|Procedure|Contrast-Enhanced Ultrasound|Undergo CEUS
15909302|NCT03578224|Procedure|Fine-Needle Aspiration|Undergo FNA
15909303|NCT03578224|Drug|Sonazoid (Perflubutane)|Sonazoid (ultrasound contrast agent) will be injected in 0.25 mL increments at 12, 3, 6, and 9 o'clock positions around the tumor using a 19 - 22 gauge needle system under EUS guidance
15909304|NCT03578211|Behavioral|Shared decision making with decision aids|For obese patients, we use shared decision making with decision aids to help them choose the suitable types of bariatric surgery.
15909305|NCT03578198|Drug|Rituximab + MG4101|"Induction phase:
~Rituximab (Truxima) 375mg/m2 IV Weekly (X4)
~MG4101 3x107 cells/kg IV Weekly (X4)
~Maintenance phase
~Rituximab (Truxima) 375mg/m2 IV q 4 weeks (X4)
~MG4101 3x107 cells/kg IV q 4 weeks (X4)"
15909342|NCT03577899|Biological|1.0 mg Conbercept Intravitreal Injection|Subjects received 1.0 mg conbercept intravitreal injection at Day 1, Week 4 and Week 8 (three injection loading dose), and treated every twelve weeks thereafter (1.0 mg, q12w) for a total of 92 weeks treatment in the study eye.
15909737|NCT03574844|Dietary Supplement|Saccharomyces cerevisiae, dose 500|Experimental arm
15909306|NCT03578172|Drug|human menopausal gonadotrophin|experimental group:Women will be given HMG 37.5-150IU daily followed by monitoring of the follicular growth (folliculometry) when serum Estradiol (E2)<100pg/ml，progesterone (P)<1ng/ml. Final oocyte maturation will be induced by administration of human chorionic gonadotropin (HCG) when there will be at least one leading follicle ≥20mm in diameter followed by luteal phase support (using progesterone supplements) after 24 hours.
15909307|NCT03578172|Drug|hormone replacement therapy|Women will be given 17 β-estradiol hemihydrate 2 mg and estrogen gel 5 g daily from day 3 of the cycle then the endometrial thickness will be assessed on day 7 by transvaginal sonography (TVS). If the endometrium is ≥ 9 mm, luteal phase support (using progesterone supplements) will be started but if the endometrium is < 9 mm, estradiol will be continued until reaching appropriate endometrial thickness and then the luteal phase support will be started. The cycle will be cancelled If the estradiol administration >60 days.
15909308|NCT03578159|Other|Chhatralaya|Chhatralaya, home for children provide living resources along with spiritual practices.
15909309|NCT03578146|Combination Product|PRT064445/Rivaroxaban|
15909310|NCT03578146|Combination Product|Placebo/Rivaroxaban|
15909311|NCT03578146|Drug|Placebo|
15909312|NCT03578133|Diagnostic Test|InBios® Active Melioidosis DetectTM-Lateral Flow Assay|Evaluation of a lateral flow assay for the detection of B.pseudomallei 6-deoxyheptan capsular polysaccharide antigen from sputum
15909313|NCT03578120|Biological|Pre-school booster vaccine|Routine vaccination with pre-school booster vaccine
15909314|NCT03578107|Behavioral|improvement of quality of stroke care|"hospital tool kits for quality improvement of reperfusion therapy ;
~organizational stakeholder and opinion leader meetings;
~data monitoring and feedback reports；
~webinar for hospital teams"
15909321|NCT03578055|Drug|BDD with UDCA|Dosage: Udex 1 capsule, 3 times daily Time of administration: 30 minutes after meal Duration of administration: From the day before surgery to 4 weeks after surgery
15909322|NCT03578055|Drug|Placebo|Dosage: 1 capsule of placebo, 3 times daily Time of administration: 30 minutes after meal Duration of administration: From the day before surgery to 4 weeks after surgery
15909323|NCT03578042|Drug|Losartan and amlodipine and hydrochlorothiazide|this is a fixed combination containing the 3 drugs
15909324|NCT03578042|Drug|Standard of care|any free triple combination therapy for hypertension given as 2 or 3 pills
15909325|NCT03578029|Drug|RGN-137|It will be applied topically to the appropriate wound once a day for up to 84 days.
15909326|NCT03578029|Drug|Placebo|It will be applied topically to the appropriate wound once a day for up to 84 days.
15909327|NCT03578016|Other|Circle of Security-Parenting|COS-P is a brief, behavioral and insight oriented therapeutic group approach for parents with the aim to promote parental sensitivity and attachment and autonomy in the parent-child relationship. The parents will participate in ten weekly 1,5-hour sessions at the clinic conducted by two COS-certified therapists. Groups will include 4-5 families at a time.
15909328|NCT03578016|Other|Treatment as Usual|TAU consists of clinical assessment and treatment.
15909329|NCT03578003|Other|Morning Bright Light Therapy|60 minutes of bright light therapy (10,000 lux) received within 90 minutes of waking
15909332|NCT03577977|Drug|Interferon beta-1b (Betaseron, Betaferon, BAY86-5046)|Betaferon was injected subcutaneously as prescribed by the treating physician.
15909333|NCT03577964|Diagnostic Test|Glucose Measurements,|Measurement of glucose Levels in bronchio alveolar secretions
15909334|NCT03577951|Procedure|high position space group|The left and right Trocar meet at the level of the sternum angle and begin to establish the operating space.
15909335|NCT03577951|Procedure|low position space group|The left and right Trocar meet under the sternum angle and begin to establish the operating space.
15909336|NCT03577938|Drug|Chinese herbal medicine|One dosage of CHM includes Artemisiacapillaris Thunb (30g), Salvia miltiorrhiza Bge (30g), Rhizoma Atractylodis Macroce- phalae (30g), Rubia cordifolia L (30g), Sieyesbeckiaorientalis L (30g). Paeoniae Radix Rubra (60g), Gardenia jasminoides Ellis (9g), Hedyotis diffusa Willd (30g) and Bletilla striata (15g) are involved for excess syndrome, and Astragalus membranaceus (30g), Radix Pseudostellariae (15g), Radix Aconiti Lateralis Praeparata (10g), Galli Gigeriae Endothelium Corneum (20g), Polygonum cuspidatum Sieb.et Zucc (15g) are involved for deficiency syndrome.
15909337|NCT03577938|Other|Control (blank)|SMT therapy includes a high-calorie diet; nucleoside analogues for HBV DNA-positive patients; sodium restriction, diuretics and paracentesis combined with albumin infusion for ascites; lactulose and L-ornithine aspartate and lactulose for HE and hyper-ammonia; hemostatic treatment for gastrointestinal hemorrhage; antibiotics for infections and renal replacement for HRS and uremic symptoms.
15909338|NCT03577925|Diagnostic Test|HPV genotype test|HPV genotype test is a diagnostic test by smearing the cervix to find out whether a patient is hpv infected, and if infected, the test can descover the concrete hpv genotype.
15909343|NCT03577899|Biological|2.0 mg Aflibercept Intravitreal Injection|Subjects received 2.0 mg aflibercept intravitreal injection at Day 1, Week 4 and Week 8 (three injection loading dose), and treated every eight weeks thereafter (2.0 mg, q8w) for a total of 92 weeks of treatment in the study eye.
15909344|NCT03577886|Drug|CDX-6114|CDX-6114 will be administered as a single, oral dose solution at dose levels of 0.225, 0.75, 2.25, and 7.5 g.
15909345|NCT03577886|Drug|Placebo|Phosphate Buffer Diluent oral solution
15909346|NCT03577873|Other|gallbladder preserved|Gallbladders will be remained after clearance of bile duct stones with ERCP and conventional therapy, such as fluid replacement and prophylactic anti infection, will be accepted.
15909347|NCT03577873|Procedure|cholecystectomy|Cholecystectomy will be done right now after clearance of bile duct stones with ERCP, and then conventional therapy will be accepted.
15909348|NCT03577860|Drug|Bupivacaine 4 mL|The interscalene brachial plexus block is performed with 4ml of bupivacaine-epinephrine 0,5%- 1:200,000
15909349|NCT03577860|Drug|Bupivacaine 15 mL|The interscalene brachial plexus block is performed with 15ml of bupivacaine-epinephrine 0,5%- 1:200,000
15909350|NCT03577847|Diagnostic Test|Rural CT scanning|Rural computer tomography for acute stroke
15909351|NCT03577834|Dietary Supplement|liquid vinegar|6% red wine vinegar (2 tablespoons providing 1.7 g acetic acid)
15909352|NCT03577834|Dietary Supplement|vinegar pill|Apple Cider Vinegar Tablets (1 tablet providing 0.0225 g acetic acid)
15909353|NCT03577808|Other|Biopsy|Patients with locally advanced rectal cancer will receive biopsy of the primary tumor before neoadjuvant chemoradiation.
15909354|NCT03577782|Biological|Entyvio (Vedolizumab)|"Antiretroviral treatment consisting in Dolutegravir (Tivicay) (50mg) + Tenofovir alafenamide (TAF) (25mg) / Emtricitabina (FTC) (200mg) (Descovy), once daily during 24 weeks.
~Entyvio (Vedolizumab) (300mg), 7 intravenous infusions at week 0 (baseline) (concomitant with ART onset), 4, 8, 12, 16, 20 and 24.
~At week 24 ART and Vedolizumab administration will be interrupted. ART will be resumed if CD4+ T-cell levels drop below 350 CD4+/μL and/or viral load increase above 10e5 HIV-RNA copies/mL (two consecutive measurements).
~Patients will be followed up until week 48."
15909355|NCT03577756|Other|Neurodevelopmental assessments|Infants' neurodevelopmental assessments will be done by the Bayley-III Baby and Child Development Assessment Scale (Bayley III) and the Gross Motor Function Measure. Bayley-III assess the development of five distinct scales to be consistent with areas of appropriate developmental assessment for children from birth to age 3. The Bayley-III revision includes Cognitive, Language, Motor, Social-Emotional, and Adaptive Behavior scales.The Gross Motor Function Measure (GMFM) has 5 dimensions: A-lying and roll- ing; B-sitting; C- kneeling and crawl- ing; D-standing; and E-walking, run- ning, and jumping. The items are scored from 0 to 3. All items are summarized and expressed as a value of total points for each dimension of the GMFM.
15909356|NCT03577743|Drug|Bevacizumab|-bevacizumab 15m.g/ kg + carboplatin 450m.g + paclitaxel 175m.g/m2 D1 /21 Day until disease progression or un acceptable toxicity .
15909357|NCT03577730|Drug|Caffeine Citrate|Prepared intravenous piggyback solutions of caffeine citrate (200 mg caffeine) will be directly delivered to the operating room prior to the surgery of enrolled participants.
15909358|NCT03577730|Drug|Dextrose Water|Prepared intravenous piggyback solutions of 5 percent dextrose water will be directly delivered to the operating room prior to the surgery of enrolled participants.
15909359|NCT03577717|Other|computerized cognitive training|participants will be trained 30 minutes/day, 3 days/week for 4 consecutive weeks.
15909360|NCT03577717|Other|occupational therapy|participants will receive craft activities of occupational therapy for 30 minutes/day, 3 days/week for 4 consecutive weeks.
15909361|NCT03577704|Drug|HLX07+Gemcitabine+Cisplatin|"Recombinant anti-EGFR humanized monoclonal antibody in combination with Gemcitabine and Cisplatin.
~HLX07, IV, weekly."
15909362|NCT03577704|Drug|HLX07+Paclitaxel+Carboplatin|"Recombinant anti-EGFR humanized monoclonal antibody in combination with Paclitaxel and Carboplatin.
~HLX07, IV, weekly."
15909363|NCT03577704|Drug|HLX07+mFOLFOX6|"Recombinant anti-EGFR humanized monoclonal antibody in combination with Oxaliplatin, Calcium Folinate and 5-FU.
~HLX07, IV, weekly."
15909364|NCT03577691|Other|Training for use of web based Decision Aid|Subjects will be guided during a 30 minutes training session to use the website
15909365|NCT03577691|Other|No training for use of web based Decision Aid|Subjects will not be guided during a 30 minutes training session to use the website
15909366|NCT03577691|Other|Pretest surveys and posttest surveys|Subjects will be randomized to one of two groups initially: Those who do not receive training for the decision aid and those who are trained to navigate the decision aid. subjects in each group will be randomized to complete pre test and posttest surveys or only posttest surveys that will take 15 mts of time
15909367|NCT03577691|Other|Only posttest surveys|Subjects will be randomized to one of two groups initially: Those who do not receive training for the decision aid and those who are trained to navigate the decision aid. subjects in each group will be randomized to complete pretest and posttest surveys or only posttest surveys.
15909368|NCT03577678|Procedure|Surgery to fix lateral half prosthesis for clavicle|Surgery to fix lateral half prosthesis for clavicle
15909369|NCT03577665|Radiation|curative proton therapy|Patients who meet the selection criteria are selected, signed for consent, and treated with proton therapy alone at 7200 cGy / 15 fractions, 5 times a week for 3 weeks
15909370|NCT03577652|Drug|Ticagrelor|Ticagrelor, 90mg, 90mg twice daily
15909371|NCT03577626|Drug|Hemay005|Hemay005 tablets will be taken orally in dose of 52.5mg at fasted dosing on period one followed by fed dosing on period two.
15909372|NCT03577626|Drug|Hemay005|Hemay005 tablets will be taken orally in dose of 52.5mg at fed dosing on period one followed by fasted dosing on period two
15909373|NCT03577613|Procedure|Open radical hysterectomy|
15909374|NCT03577613|Procedure|laparoscopic radical hysterectomy|
15909375|NCT03577613|Procedure|Robotically assisted radical hysterectomy|
15909376|NCT03577600|Procedure|QMRT with the Cytotron®|Cytotron® utilizes a combination of instantaneous magnetic field and RF at the safe, lowerend of the EM spectrum. Radiofrequency waves are computed based on individualized PD measurements of the target lesion(s) for therapeutic purpose. Its working principle is based on the underlying theory of magnetic resonance.
15909377|NCT03577587|Dietary Supplement|Silitidil for 21 days|daily ingestion of herbal galactagogue Silitidil over time period of 3 weeks
15909487|NCT03576664|Drug|Placebo oral capsule|Cross-over, randomized, placebo-controlled study.
15909378|NCT03577587|Dietary Supplement|Placebo for 21 days|daily ingestion of Placebo preparation over time period of 3 weeks
15909379|NCT03577574|Procedure|retrobulbar anesthesia|2% lidocaine 4ml injected into retrobulbar space
15909380|NCT03577574|Procedure|peribulbar anesthesia|2% lidocaine 4 to 8ml injected into peribulbar space
15909381|NCT03577574|Procedure|two step anesthesia|conjunctival cul-de-sac anesthetized with 0.5% proparacaine hydrochloride drops three times + 2% lidocaine 0.6 to 0.8ml subconjunctival injection
15909382|NCT03577561|Other|Proficiency Based Progression Training in Phlebotomy|Trainees will receive an online didactic education package and a simulation skill training module. Both of these education and training platforms will be derived from the procedure characterisation and benchmarked on experienced practitioner's performance. Trainees will be required to engage with the education and training platforms in a process of deliberate practice learning until they demonstrate the requisite performance benchmark. Proficiency demonstration will be mandatory before progressing to ward proctored skill supervision on real patients. In addition, the doctors in training will receive ongoing and proximate feedback on their sampling mislabeling.
15909383|NCT03577548|Other|Auto- questionnaires|10 auto-questionnaires are submitted to the patient during his/her consultation (which is part of the standard care).
15909384|NCT03577535|Dietary Supplement|Oncoxin®|Chemo-, radiotherapy or their combination + standard oral mucositis treatment + ONCOXIN 25 ml twice daily for 20 days;
15909385|NCT03577522|Device|Avenir cementless hip stem|Avenir cementless hip stem vs Corail HA-coated hip stem
15909386|NCT03577522|Device|Corail HA-coated hip stem|Avenir cementless hip stem vs Corail HA-coated hip stem
15909387|NCT03577509|Drug|ABCD|Intravenous infusion of dexamethasone 5mg before ABCD intravenous administration; Single infusion.
15909388|NCT03577496|Other|Peppermint oil|A cotton ball with three drops of peppermint oil will be waved under the patient's nares.
15909389|NCT03577483|Procedure|voice recordings|A digital processing of voice recordings (from 30 to 45 minutes) will be performed for each participant, using a high quality digital recorder: the DIANA (computerized device of acoustic analysis) and the EVA-2 workstations (assisted Evaluation system Voice).
15909390|NCT03577470|Drug|D/C/F/TAF Fixed-Dose Combination (FDC)|Participants in treatment with D/C/F/TAF FDC, coming from different treatment histories will be observed in this study. No interventions will be administered as a part of this study.
15909391|NCT03577457|Drug|oxytocin nasal spray|intranasal administration of oxytocin (24 IU)
15909392|NCT03577457|Drug|ATD treatment|oral administration of ATD (75.2g) (Acute Tryptophan Depletion)
15909393|NCT03577457|Drug|intranasal placebo treatment (placebo-control for oxytocin)|intranasal administration of placebo nasal spray
15909394|NCT03577457|Drug|oral placebo treatment (placebo-control for ATD)|oral administration of a tryptophan-balanced mixture (78.2g)
15909395|NCT03577431|Biological|arTreg-CSB|"Participants will receive a single dose of Treg product (arTreg-CSB). The target dose is 2.5 to 125 x 10^6 total cells. If a minimum arTreg-CSB dose of 1 to < 2.5 x 10^6 cells, the product will be infused. If the dose obtained after product manufacture is < 1 x 10^6 cells, the product will not be infused. When the dose obtained after product manufacture is > 125 x 10^6 cells, a dose aliquot will be prepared so that the administered dose will be ≤ 125 x 10^6 cells, and ≥ 2.5 to 125 x 10^6 total cells.
~Method of receipt: peripheral intravenous (IV) infusion, administered over 15 to 30 minutes."
15909396|NCT03577431|Procedure|leukapheresis|"Leukapheresis will be the method employed to recover peripheral blood mononuclear cells (PBMCs) from the allograft recipient. The recipient will undergo the procedure prior to initiating the cyclophosphamide conditioning regimen.
~Procedure 72 to 120 hours prior to Treg product (arTreg-CSB) IV infusion."
15909397|NCT03577431|Drug|cyclophosphamide|40 mg/kg administered intravenously (IV) within 24 to 72 hours prior to Treg product (arTreg-CSB) infusion.
15909398|NCT03577431|Drug|mesna|Mesna is administered intravenously to inhibit hemorrhagic cystitis induced by cyclophosphamide. Administration of mesna is per institutional practice with cyclophosphamide.
15909399|NCT03577431|Drug|everolimus|"EVR, an immunosuppressant (IS), is approved by the FDA for the prophylaxis of allograft rejection in adults receiving a liver transplant. Between day 30 and wk. 48 post-transplant, participant evaluation for eligibility to be converted to an EVR-based IS regimen will occur.
~At the start of conversion from tacrolimus (TAC) to EVR IS:EVR will be started at 1.5 mg taken by mouth BID, with dose adjusted to achieve a trough blood level of 5-8 ng/mL. Once an EVR trough level of ≥ 5 ng/mL is achieved, baseline TAC dose will be reduced to achieve a trough level of 3-5 ng/mL.
~When target EVR and TAC levels are achieved/ maintained over two consecutive measurements, and liver function tests, ALT and GGT, are ≤50 U/L, participants will be considered successfully converted to EVR-based IS regimen. EVR doses will be administered, monitored and adjusted over time, per protocol."
15909400|NCT03577418|Behavioral|Clinician-facilitated educational intervention|People with dementia (PWD) will complete the Preferences for Everyday Living (PELI). Care partners will complete the PELI from the perspective of the PWD (i.e., as if acting as surrogate decision-makers). Research staff will then review these assessments, highlighting areas of discrepancy in the importance of various preferences. A 30-minute preferences-based discussion will then be facilitated by the research clinician. This discussion will include review of the discrepancies identified in the assessments. The PWD and the care partners will then be encouraged to identify one area of discrepancy and to come together with a concrete action plan to resolve that area of discrepancy. A standardized document describing neuropsychiatric symptoms and reviewing the unmet needs hypothesis will be discussed with PWD and the care partners.
15909401|NCT03577418|Behavioral|Enhanced usual care|In addition to the usual clinical care, the standardized document describing NPS and reviewing the unmet needs hypothesis will be given to the PWD and the care partner to review.
15909402|NCT03577392|Drug|oxaliplatin + capecitabine (XELOX chemotherapy)|Oxaliplatin(130mg/m2 over 2h)was intravenously administated for at least 2h on day 1. Capecitabine(1000mg/m2 twice daily)was oral administrated from the evening of day 1 to the morning of day 15.
15909403|NCT03577392|Drug|rebombniant human endostatin|Endostar is a recombinat human endostatin with antiangiogenic properties that has been useful in treating a wide range of cancers and shows promise for use in combination treatment for advanced colorectal cancer. The dose of Recombinant human endostatin on day -5 was calculated according to the patients's body surface area, to provide a CIV 7 days' dose in physiological saline to 240mL volume.
15909738|NCT03574844|Dietary Supplement|Saccharomyces cerevisiae, dose 1000|Experimental arm
15909404|NCT03577379|Other|Whole Blood Fibrin Clot|For all patients assigned to the treatment group, 35mL of whole blood will be obtained during surgery by an anesthesiologist. 5 mL of the blood will be sent for pre-clot formation cell count evaluation for platelets, red blood cells and white blood cells. The remaining 30mL will be placed into a sterile container with a sintered glass cylinder supported by the lid for fibrin clot formation. The clot formation cups will be placed on a rotator at room temperature for 10 minutes at 125rpm. The fibrin clot will be removed and 5mL of the post-clot serum sent for post-clot formation cell count evaluation for platelets, red blood cells, and white blood cells.
15909405|NCT03577353|Behavioral|Dual Task Walking (DTW)|Each training session began with 8 min of general warm-up and 2 min walk around the gym. Then, for safety reasons, the participants were attached to a harness. The participants began walking slowly on the treadmill for 3 min. In the following phases the participants walked at the same speed, while training with 3 VR games. Each session lasted 3 min, and 3 min of single walking was performed between VR sessions. After the final VR session, 2 min of single-task walking was performed in order to allow for recovery. The time walked in each trial from the starting point to the destination was kept constant at 20 min.
15909406|NCT03577353|Behavioral|Single-task Treadmill Walking (TMW)|this intervention, participants performed 8 min of general warm-up and 2 min walk around the gym, and then continued to walk for another 20 min on the treadmill at a speed that was equivalent to the intensity of 60%-70% of their heart rate reserve.
15909407|NCT03577340|Other|implant of cardiac device as per guidelines|Observation of performance to validate matrix
15909408|NCT03577314|Other|miscarriage|(ORTHOPANTOMOGRAPH® OP300 PANORAMIC, Instrumentarium Dental, Tuusula, Finland,63 kVp, 0.8 mA, 0.5 s).
15909409|NCT03577301|Behavioral|Clinic-based Delivery|A minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based intervention sessions.
15909410|NCT03577301|Behavioral|Remote Delivery|A minimum of 2 community health workers (CHWs) will be trained to deliver intervention sessions to the participant in a location remote from the clinic setting.
15909411|NCT03577301|Behavioral|Multi-modal Delivery|A minimum of 2 community health workers (CHWs) will be trained to deliver clinic-based or remote intervention sessions. First MI session is in person immediately after baseline. Sessions 2-4 can be delivered in person or remotely based on youth preference.
15909412|NCT03577288|Behavioral|manipulation of the level of realism|"The realism of the virtual experience will be manipulated. In one condition the realism will be high and in another condition the realism will be low. In addition, emotional category of stimuli for each virtual experience condition will be manipulated. Thus, each participant will be submitted to six virtual experiences (e.g., high realism with negative stimuli, low realism with negative stimuli, high realism with positive stimuli).
~The measures of the pupillary responses, gaze fixation, heart rate, head movement (only in part A) and Late Positive Potential (EEG - only in part B) will be realized. In addition, the participants will respond to the scales and questionnaire evaluating their emotion, feeling of presence and feeling of immersion."
15909413|NCT03577288|Behavioral|manipulation of the presence and size of avatar|"The presence of avatar in the virtual experience will be manipulated. In one condition the avatar will be present and in another condition the avatar will not be present. In addition, emotional category of stimuli for each virtual experience condition will be manipulated. Thus, each participant will be submitted to six virtual experiences (e.g., with avatar and negative stimuli, without avatar and negative stimuli, with avatar and positive stimuli, etc.).
~Children will be exposed to only one of the two possible situations: with an avatar or without an avatar for the entire experience. Adults will be exposed to only one of the four possible situations: with standard size avatar, with giant avatar, with tiny avatar, or without avatar.
~The measures of the pupillary responses, gaze fixation, heart rate, head movement will be realized. In addition, the participants will respond to the scales and questionnaire evaluating their emotion, feeling of presence and feeling of immersion."
15909414|NCT03577288|Behavioral|manipulation of interaction|"Virtual experience condition will be manipulated. In one condition the participants will be exposed to the virtual experience in which they will be able to interact with some of the stimuli, in another condition they will not be able to interact with the stimuli (passive watching). In addition, emotional category of stimuli for each virtual experience condition will be manipulated. Thus, each participant will be submitted to six virtual experiences (e.g., interaction possible - negative stimuli, interaction impossible - negative stimuli, interaction possible - positive stimuli).
~The measures of the pupillary responses, gaze fixation, heart rate, head movement will be realized. In addition, the participants will respond to the scales and questionnaire evaluating their emotion, feeling of presence and feeling of immersion."
15909415|NCT03577288|Behavioral|manipulation of the nature of stimulus|The nature of the stimuli with which the participants will interact will be manipulated. During virtual experience the participants will have a choice to interact or not with the virtual environment, in one condition with animate stimuli and in another condition with inanimate stimuli. In addition, emotional category of animate and inanimate stimuli will be manipulated. Thus, each participant will be submitted to six virtual experiences (e.g., condition with animate negative stimuli, condition with inanimate negative stimuli, condition with animate positive stimuli). The measures of the pupillary responses, gaze fixation, heart rate, head movement will be realized. In addition, the participants will respond to the scales and questionnaire evaluating their emotion, feeling of presence and feeling of immersion.
15909416|NCT03577275|Drug|NST-4016 600mg|Likely maximum therapeutic dose of NST-4016
15909417|NCT03577275|Drug|Placebo oral capsule|Placebo for comparison with moxifloxacin and potential NST-4016 effects
15909418|NCT03577275|Drug|Moxifloxacin 400mg|Active comparator with known effect on QT interval
15909419|NCT03577275|Drug|NST-4016 2000mg|Supratherapeutic dose of NST-4016
15909420|NCT03577262|Other|[11C]-UCB-J|IV radioligand given prior to and during positron emission tomography (PET) scan
15909421|NCT03577249|Drug|Dialysis Solutions|Solution A: 3mmol/L of acetate anion; Solution B: 1mmol/L of citrate anion
15909422|NCT03577236|Device|Zenflow Spring System|The Zenflow Spring System consists of the Spring Delivery System with Implant, Spring Scope, Camera Control Unit (CCU), Measurement Tool, and Spring Retrieval Tool.
15909423|NCT03577223|Other|Whole Eggs|3 whole eggs per day for 4 weeks
15909424|NCT03577223|Other|Egg White-Based Egg Substitute|3-egg equivalent of egg white-based egg substitute per day for 4 weeks
15909425|NCT03577210|Procedure|augmentation genioplasty|augmentation genioplasty with patient-specific PEEK implant
15909426|NCT03577184|Drug|Metformin/Vildagliptin|Vildagliptin belongs to dipeptidyl peptidase-4 (DPP-4) inhibitor. Inhibition of dipeptidyl peptidase-4 (DPP-4) and metformin is a Biguanides.
15909427|NCT03577171|Drug|ABI-H0731|Participants will receive 300mg QD of ABI-H0731 tablets orally.
15909428|NCT03577171|Drug|SOC ETV|Participants will receive SOC ETV (0.5 mg QD) orally as per approved package insert.
15909429|NCT03577171|Drug|Placebo Oral Tablet|Participants will receive matching QD placebo tablets orally.
15909430|NCT03577158|Device|Closed-loop controller with exercise mitigation module|"Each subject will undergo three exercise tests, each one at 1-2 week intervals, thus completing the 3 experiments in about 6 weeks. The day of the experiment, the participant will do 3 sets of 15 minutes of cycloergometer at 70% of VO2max with 5 minutes of rest between them. On the first arm, participants will receive Sliding Mode Reference Conditioning (SMRC) Closed-loop insulin administration with a mitigation mode, based on subcutaneous continuous glucose monitoring (First arm, Closed-loop study with mitigation module).
~Commercial insulin infusion systems and continuous glucose monitoring devices will be used."
15909431|NCT03577158|Device|Closed-loop controller without exercise mitigation module|"On the second arm, participants will receive Sliding Mode Reference Conditioning (SMRC) Closed-loop insulin administration without a mitigation mode, based on subcutaneous continuous glucose monitoring (Second arm, Closed-loop study without mitigation module).
~Commercial insulin infusion systems and continuous glucose monitoring devices will be used."
15909432|NCT03577158|Device|Open-loop insulin infusion system|Standard subcutaneous insulin infusion based on the individual insulin sensibility. Commercial insulin infusion systems and continuous subcutaneous glucose monitoring devices will be used.
15909433|NCT03577145|Dietary Supplement|Tomato, onion & lovage soup with inulin|Source of polyphenols and non digestible carbohydrate
15909434|NCT03577145|Dietary Supplement|Tomato, onion & lovage soup|Source of polyphenols
15909435|NCT03577145|Dietary Supplement|Inulin|Source of non digestible carbohydrate
15909436|NCT03577132|Drug|Neoadjuvant atezolizumab|"Atezolimumab
~At a fixed dose of 1200 mg as a 60-minute intravenous infusion (1st), then as a 30-minute intravenous infusion (2nd and 3rd)
~Every 3 weeks, for a total of 3 cycles prior to radical cystectomy"
15909437|NCT03577119|Dietary Supplement|Full-fat yogurt|Controlled diet that includes three daily servings of whole (3.25% fat) yogurt.
15909438|NCT03577119|Dietary Supplement|Non-fat yogurt|Controlled diet that includes three daily servings of fat-free yogurt.
15909439|NCT03577106|Device|Transcranial magnetic stimulation (TMS)|Theta Burst Stimulation (TBS), a form of TMS, will be targeted to the Inferior Parietal Cortex based on neural navigation software. TBS will be delivered for about 5-6 minutes, five days a week for two weeks, for a total of ten sessions.
15909440|NCT03577093|Other|There is no intervention at all.|There is no intervention at all.
15909441|NCT03577080|Other|ET+RT+ NMES|Endurance training, resistance training and neuromuscular electrical stimuation were prformed. Intensity was gradually increased.
15909442|NCT03577067|Procedure|Liver resection for primary and secondary disease|Liver resection in parenchyma-sparing setting for primary and secondary disease
15909443|NCT03577054|Behavioral|HBB Prompt|Mobile app developed through user-centred design in phase 1 of this study
15909444|NCT03577054|Behavioral|Low-Dose High Frequency training|Participants will be encouraged to practice their HBB skills daily
15909445|NCT03577028|Biological|HPN424|In Part 1 (Dose Escalation), HPN424 will be administered once weekly via IV infusion. In Part 2 (Dose Expansion), HPN424 will be administered at the recommended phase 2 dose(s) once weekly via IV infusion.
15909446|NCT03577002|Other|Serious Illness Care Program (SICP)|SICP includes the Serious Illness Conversation Guide, which provides patient-tested language for initial and follow-up conversations; training materials, including didactic materials and case studies for structured role playing; and implementation guidance including recommended approaches to identifying appropriate patients and templates for documentation of conversations
15909447|NCT03576989|Dietary Supplement|EPA+DHA|EPA+DHA are the n-3 polyunsaturated fatty acids contained in fish oil
15909448|NCT03576989|Other|placebo|placebo contains mineral oil
15909449|NCT03576976|Behavioral|Cognitive Remediation|Computer-based exercises targeting impairments in cognitive domains (sensory processing, processing speed, attention, working memory, memory, executive functions) are paired with verbal discussions and group-based activities to strengthen metacognition to and bridge newly learned cognitive skills to everyday life.
15909450|NCT03576963|Drug|Guadecitabine|Given SC
15909451|NCT03576963|Biological|Nivolumab|Given IV
15909452|NCT03576937|Diagnostic Test|GUARDANT360|GUARDANT360 is a validated cfDNA next-generation sequencing assay that identifies variants in 73 genes associated with several cancers.
15909453|NCT03576924|Behavioral|Imposed-MICT|Moderate-Intensity Continuous Training (MICT) is continuous exercise for 30 min/session at 60-65% of heart rate max for 5 times/week, consistent with the physical activity guidelines of 150 min/week of moderate activity. Individuals are asked to engage in MICT exercise only (IM-MICT) during the supervised and unsupervised exercise sessions. During the supervised exercise the intensity will be based on the HR monitors, and affective and psychophysiological responses of perceived exertion. The exercise training is paired with 30 min behavioural counselling that is identical for all three interventions.
15909454|NCT03576924|Behavioral|Imposed-HIIT|Individuals randomized to IM-HIIT will be asked to engage in High-Intensity Interval Training (HIIT) exercise only, which is 5 repeated vigorous intervals of 1-min duration at 85-90% of heart rate max with 1-min recovery periods, with 3-min warm-up and 2-min cool-down. Total session duration is 15 min for 5/week and it matches the guidelines of 75 min of vigorous exercise per week. During the supervised and unsupervised exercise sessions participants will perform a 15 min bout of HIIT. During the supervised exercise the intensity will be based on the HR monitors, and affective and psychophysiological responses of perceived exertion. The exercise training is paired with 30 min behavioural counselling that is identical for all three interventions.
15909488|NCT03576651|Biological|JHL1149|Each patient may receive single dose of JHL1149 1mg/kg by intravenous infusion
15909489|NCT03576651|Biological|Bevacizumab|Each patient may receive single dose of Avastin 1mg/kg by intravenous infusion
15909490|NCT03576651|Biological|Bevacizumab|Each patient may receive single dose of Avastin 1mg/kg by intravenous infusion
15909491|NCT03576638|Drug|Accordion Pill Carbidopa/Levodopa|AP 50/500 TID days 2-7
15909455|NCT03576924|Behavioral|CHOICE|Participants will first be familiarized with HIIT and MICT in randomized, counter-balanced order and subsequently they will always self-select the exercise type for the supervised and unsupervised exercise sessions. The IM-HIIT and IM-MICT protocols will match to the parallel imposed conditions. During the supervised exercise the intensity will also be based on affective and psychophysiological responses of perceived exertion. Throughout the 3-week intervention as well as during the 12-month follow-up, participants in the CHOICE condition will be told to choose either HIIT or MICT each time they exercise. The exercise training is paired with 30 min behavioural counselling that is identical for all three interventions.
15909456|NCT03576911|Dietary Supplement|Coenzyme Q10|
15909457|NCT03576911|Other|Placebo|
15909458|NCT03576885|Drug|inhaled nitric oxide|inhaled nitric oxide will be administered starting at 20 ppm. Treatment will continue for 14 days or until resolution of pulmonary hypertension
15909459|NCT03576885|Drug|Placebo|placebo will be administered starting at 20 ppm. Treatment will continue for 14 days or until resolution of pulmonary hypertension
15909460|NCT03576872|Other|Psychoeducational|Providing a binder of educational materials with nurse-led instruction in preparing pancreatic and colorectal cancer patients for chemotherapy
15909461|NCT03576859|Other|blood sample|Peripheral venous blood is collected before liver transplantation and after restoration of liver function
15909462|NCT03576846|Other|Stretching and Spinal manipulative therapy|Subjects will be instructed to perform a series of progressively difficult stretching exercises for the neck and upper back muscles. In addition, subjects will be treated with Spinal manipulative therapy
15909463|NCT03576846|Other|Stretching|Subjects will be instructed to perform a series of progressively difficult stretching exercises for the neck and upper back muscles.
15909464|NCT03576833|Device|Elipse Balloon system|intragastic balloon
15909465|NCT03576820|Drug|Lidocaine|Baseline pain score and associated migraine symptoms (such as nausea, vomiting, photophobia, and phonophobia) will be recorded for each subject. Subjects will then receive intranasal lidocaine via atomizer. Pain scores will be reassessed at 5, 10, and 20 minutes. Improvement in associated symptoms will be reassessed at 20 minutes.
15909466|NCT03576820|Drug|Placebo|Baseline pain score and associated migraine symptoms (such as nausea, vomiting, photophobia, and phonophobia) will be recorded for each subject. Subjects will then receive 0.9% sodium chloride solution via atomizer. Pain scores will be reassessed at 5, 10, and 20 minutes. Improvement in associated symptoms will be reassessed at 20 minutes.
15909467|NCT03576807|Drug|CD20 CAR-T cells|A total of 1 - 20×10^6 CD20 CAR-T cells/kg will be administered by IV infusions.
15909468|NCT03576794|Drug|Leflunomide 20 mg|During the first 2 weeks after randomization patients will receive Leflunomide 20 mg every other day. After 2 weeks Leflunomide will be increased to 20 mg once daily and this therapy will be continued during 12 months.
15909469|NCT03576794|Drug|Prednisolone|Patients in both groups will receive prednisolone 15 mg once daily and will be randomized within 4 weeks of the start of glucocorticoid therapy (prednisolone). Prednisolon will be tapered according to a short fixed protocol with a slow gradual taper till 0 in week 27.
15909470|NCT03576781|Device|Real iTBS|This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key)
15909471|NCT03576781|Device|Sham iTBS|This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.
15909472|NCT03576781|Device|Real cTBS|This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key).
15909473|NCT03576781|Device|Sham cTBS|This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.
15909474|NCT03576768|Device|Real cTBS|This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key)
15909475|NCT03576768|Device|Sham cTBS|This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.
15909476|NCT03576768|Device|Real iTBS|This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key).
15909477|NCT03576768|Device|Sham iTBS|This will be delivered with the Magventure Magpro system; 600 pulses with the active sham coil (double blinded using the USB key). The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.
15909478|NCT03576755|Drug|Spironolactone 100mg|Spironolactone capsules will be prepared from USP grade powder at a dose of 100 mg.
15909479|NCT03576755|Drug|Placebo oral capsule|Matching placebo capsules of the same color, mass, and appearance to the spironolactone capsules will be filled using microcrystalline cellulose powder.
15909480|NCT03576742|Diagnostic Test|potential biomarkers|facs analysis, microbiome analysis
15909481|NCT03576716|Drug|D6-25-hydroxyvitamin D3|Intravenous administration of a deuterium-labeled 25(OH)D3 to evaluate the metabolic clearance of 25(OH)D3
15909482|NCT03576703|Other|Exercise with and without SSB ingestion|Consumption of a prescribed diet with and without SSB and performance of moderate aerobic exercise or resting/control
15909483|NCT03576690|Biological|REGN3470-3471-3479|
15909484|NCT03576677|Drug|Levosimendan|"Levosimendan, 2.5 mg/mL concentrate for dilution. 5 mL of the study drug will be injected into a 245 mL isotonic glucose solution.
~Patients will receive a 6 hours infusion of this study drug at an infusion rate of 0.2 µg/kg/min."
15909485|NCT03576677|Drug|Placebo|"The placebo solution will be prepared by adding 10 mL of 5% dextrose to a vial containing Soluvit (vitamin B) under aseptical conditions. 5 mL of this solution is then added to 245 mL of isotonic sodium chloride solution.
~5% dextrose and vitamin B are added to ensure yellow coloring indistinguishable from the active drug (levosimendan).
~Patients will receive a 6 hours infusion of this study drug. Infusion rate will be calculated in similar fashion to the levosimendan group."
15909486|NCT03576664|Drug|Carvedilol 25mg|Cross-over, randomized, placebo-controlled study.
15909493|NCT03576625|Dietary Supplement|High Oleic Sunflower Oil|Consume oil smoothie (emulsified HOSO) with a meal once daily for 9 weeks
15909494|NCT03576625|Dietary Supplement|Buglossoides Oil|Consume oil smoothie (emulsified Buglossoides oil) with a meal once daily for 9 weeks
15909495|NCT03576612|Biological|AdV-tk|Given IT
15909496|NCT03576612|Drug|Valacyclovir|Given PO days 1-14; 1-3 days post surgery
15909497|NCT03576612|Radiation|Radiation|Undergo RT, 60Gy in 30 daily fractions M-F for 6weeks
15909498|NCT03576612|Drug|Temozolomide|Given PO during RT 75mg/m2 daily during RT Post RT cycle 1: 150mg/m2 days 1-5 150mg/m2 cycle 2-6: days 1-5 (150-200mg/m2)
15909499|NCT03576612|Biological|Nivolumab|day 15 post surgery 240mg IV q2wks x 26 doses , up to 52 weeks
15909500|NCT03576612|Other|Laboratory Biomarker Analysis|correlative studies
15909501|NCT03576599|Drug|Zoledronic Acid Injectable Product|One Group are randomiced to Zoledronic Acid Injectable Product and one Group to Placebo
15909502|NCT03576599|Drug|Placebo|Placebo
15909503|NCT03576586|Behavioral|Brief computerized intervention|"Brief computerized intervention (computer game Tetris) plus usual care in the maternity department"
15909504|NCT03576586|Behavioral|Attention placebo control|Brief cognitive task plus usual care in the maternity department
15909505|NCT03576573|Device|PROCOTYL® C|Hip Arthroplasty
15909506|NCT03576560|Other|Retrospective Chart Review|Retrospective Chart Review
15909507|NCT03576547|Drug|Dexamethasone|Given PO or IV
15909508|NCT03576547|Drug|Ponatinib Hydrochloride|Given PO
15909509|NCT03576547|Biological|Rituximab|Given IV
15909510|NCT03576547|Drug|Venetoclax|Given PO
15909511|NCT03576534|Other|Use of prebypass ultrafiltration (PBUF)|In addition to standard of care for cardiopulmonary bypass, in the study arm prebypass ultrafiltration will be performed.
15909512|NCT03576521|Combination Product|CT + Ocoxin-Viusid|"The included patients received the Ocoxin-Viusid nutritional supplement at a rate of 75 ml daily (25 ml in 3 doses every 8 hours) administered after main meals diluted in milk or juice. The treatment will start a week before, it will be maintained throughout the coventional chemotherapy treatment* and up to three weeks after the end of the treatment.
~*All patients should receive the CT Adriamycin 60 mg per m2 of Body Surface (BS) and Cyclophosphamide Infusion intravenous every 21 days, up to a total of 4 to 6 cycles according to protocols provided in the center."
15909513|NCT03576521|Combination Product|CT + Placebo|"The included patients received the OV placebo in oral solution at a rate of 75 ml daily (25 ml in 3 doses every 8 hours), administered after main meals diluted in milk or juice. The treatment will start a week before, it will be maintained throughout the coventional chemotherapy treatment* and up to three weeks after the end of the treatment.
~*All patients should receive the CT Adriamycin 60 mg per m2 of Body Surface (BS) and Cyclophosphamide Infusion intravenous every 21 days, up to a total of 4 to 6 cycles according to protocols provided in the center."
15909514|NCT03576508|Drug|CNTX-4975-05|1 mg (2mL) IA injection
15909515|NCT03576508|Drug|Qutenza|8% topical patch
15909516|NCT03576508|Drug|Lidocaine (without epinephrine)|15 mL IA injection of 2% lidocaine (without epinephrine)
15909517|NCT03576495|Other|PACTS curriculum|"The cultural dexterity curriculum, known as PACTS (Provider Awareness Cultural Dexterity Toolkit for Surgeons) focuses on developing cognitive skills to adapt to individual patients' needs to ensure personal, patient-centered surgical care.
~The curriculum is comprised of four educational modules on establishing trust in the physician-patient relationship, communicating effectively with patients with limited English proficiency, discussing informed consent, and issues surrounding pain management. Each module consists of an independent learning activity, an interactive role-play, and a post-lesson assessment."
15909518|NCT03576482|Other|Transport on foot|Patients go to operating room walking with their families and with their normal clothes
15909519|NCT03576469|Biological|C1-esterase inhibitor [recombinant] (C1-INH-R)|C1-INH-R is FDA approved and indicated for the treatment of acute attacks of angioedema in adolescent and adult patients with Hereditary Angioedema (HAE) as a replacement for low levels of C1-esterase inhibitor or low function of C1-esterase inhibitor
15909520|NCT03576456|Drug|Alprazolam 0.5 mg|receive alprazolam prior to angio
15909521|NCT03576456|Drug|Placebo Oral Tablet|receive placebo prior to angio
15909522|NCT03576443|Drug|Idelalisib|Idelalisib 150 mg x 2 p o
15909523|NCT03576430|Device|active stress handling|biofeed back stress handling
15909524|NCT03576417|Drug|Cisplatin|Intravenous
15909525|NCT03576417|Drug|Nivolumab|Intravenous
15909526|NCT03576417|Radiation|RT|IMRT 66 Gy / 6.5 weeks
15909527|NCT03576404|Other|Patient-Centered Pharmacist Care|A comprehensive interview applying the concepts of Medication Therapy Management (MTM) and Motivational Interview (MI)
15909528|NCT03576391|Behavioral|Control condition|45 minute rest while seated. Watching an animated movie, sleeping was not allowed.
15909529|NCT03576391|Behavioral|Rapid Arm Movements|2 blocks of 80 trials of RAM in either a forward (n = 40) or backward (n = 40) shoulder flexion direction and back to neutral as fast as possible, with maintaining extension in the elbow. Visual cues (arrows) indicated the movement direction.
15909530|NCT03576391|Behavioral|Physical fatigue condition|40 minutes rest while seated followed by static endurance tasks, i.e. modified Biering-Sörensen task and static abdominal curl task.
15909531|NCT03576391|Behavioral|Cognitive fatigue condition|45 minutes of a cognitively fatiguing condition consisting of a modified incongruent Stroop color-word task.
15909532|NCT03576378|Drug|BrentuximabVedotin (BV)|All patients will be treated with 6 cycles of BV-EPEM
15909533|NCT03576365|Behavioral|VOICE Intervention Arm|"Introductory and background information about voice problems and psychosocial distress
~Examples of concerns raised by patients with voice problems (e.g., I feel left out of conversations because of my voice problem)
~Information about perceived control and how improving perceived control can lead to decreased distress
~Examples of strategies that have helped patients identify controllable and uncontrollable aspects of their voice problems (e.g., I learned to plan to take breaks to rest my voice between teaching classes)
~Self-guided exercises designed to help improve perceived control and develop better management skills for voice problem symptoms"
15909568|NCT03576118|Drug|Deep neuromuscular block|Deep neuromuscular block using high dose rocuronium and 8 mmHg pneumoperitoneum
15909569|NCT03576118|Drug|Moderate neuromuscular block|Moderate neuromuscular block using moderate dose rocuronium and 12-15 mmHg pneumoperitoneum
15909534|NCT03576365|Behavioral|Information-Only Arm|"General introduction of the program and background on voice related information in an interactive manner
~Examples of what patients want to learn more about the voice (e.g., I would like to learn more about how the voice works when it is healthy)
~Information on the anatomy of the voice and how the voice works
~Educational materials to help understand voice physiology and function
~Self-guided learning exercises (e.g., what are some things about vocal function that you would like to learn more about?)"
15909535|NCT03576352|Other|a rapid sequence tracheostomy (RST) on rabbit cadaver|"The Rapid Sequence Tracheostomy (RST) consists of the following steps:
~Orientational palpation and vertical midline skin incision followed by separation of the strap muscles
~Exposure of the trachea and cricoid followed by anterior luxation of the trachea with a Backhaus towel clamp
~Perform a vertical puncture with a tip scissors between the Cricoid and 1st tracheal ring followed by a vertical incision of no more than 2 rings in length.
~An age adapted tracheal tube is inserted into the trachea and the lungs are ventilated."
15909536|NCT03576339|Procedure|Free Gingival Graft|Free gingival graft removal from palate for socket preservation
15909537|NCT03576339|Device|SHAM Electric stimulation|Simulation of electric stimulation protocol for 120 seconds once a day in five consecutive days. In Sham stimulation non current will be applied.
15909538|NCT03576339|Device|Electric Stimulation|Local Electric Stimulation for 120 seconds once a day in five consecutive days.
15909539|NCT03576326|Behavioral|Drawing Incentive|The Monetary Reward intervention is a drawing reward, in which participants are eligible for weekly rewards based on toothbrushing performance.
15909540|NCT03576313|Drug|dihydroartemisinin-piperaquine (DP)|DP will be available as tablets of 320/40mg and 160/20mg piperaquine/ dihydroartemisinin per tablet. Administration of a full course of DP will be done as per manufacturer's guidelines once daily for 3 days and according to body weight. DP will be taken orally with water and without food
15909541|NCT03576313|Drug|ivermectin (IVM)|IVM will be available as tablets of 3mg or 6mg strength. It will be given at 300-400μg/kg/day over 3 days (to the nearest whole tablet). IVM will also be taken on an empty stomach with water
15909542|NCT03576313|Other|standard malaria control interventions only|this is the standard malaria control interventions in the Gambia
15909543|NCT03576287|Drug|Apremilast Oral Product|Apremilast
15909544|NCT03576274|Behavioral|Technology Enhanced Home Exercise (TEHE)|A 12 week program including one 60-minute goal setting and exercise training program and follow up phone calls.
15909545|NCT03576274|Behavioral|Auricular Point Acupressure (APA)|A non invasive complementary method to provide pressure on the ear points.
15909546|NCT03576274|Behavioral|Mindfulness body scan (MBI)|The open, nonjudgmental attention to move one's attention calmly to the different part of the body
15909547|NCT03576261|Other|Preoperative colloid fluid bolus (Gelofusine)|Preoperative colloid fluid bolus
15909548|NCT03576261|Diagnostic Test|Preoperative transthoracic echocardiography|Screening of biventricular systolic and diastolic function of the heart and level of venous return by transthoracic echocardiography approximately one hour before preoperative fluid therapy and anesthesia induction.
15909549|NCT03576248|Device|In-phase 6 Hz prefronto-parietal tACS|tACS is a non-invasive stimulation technique that works by delivering a weak sinusoidally oscillating electrical current to the surface of the skull to entrain oscillations in the brain.
15909550|NCT03576248|Device|Sham prefronto-parietal tACS|tACS is a non-invasive stimulation technique that works by delivering a weak sinusoidally oscillating electrical current to the surface of the skull to entrain oscillations in the brain.
15909551|NCT03576248|Device|2 mA left prefrontal tDCS|tDCS is a form of neuromodulation method where very low levels of constant current are delivered to specifically targeted areas of the brain
15909552|NCT03576248|Device|Sham left prefrontal tDCS|tDCS is a form of neuromodulation method where very low levels of constant current are delivered to specifically targeted areas of the brain
15909553|NCT03576235|Drug|PG102P|Daily dose of 1.5g
15909554|NCT03576235|Drug|Placebo|Daily dose of placebo
15909555|NCT03576222|Device|PICO DRESSING|USE PICO DRESSING ON SURGICAL INCISION AFTER ABDOMINAL WALL REPAIR IN THE SURGICAL ROOM
15909556|NCT03576222|Device|MEPORE dressing|MEPORE dressing
15909557|NCT03576209|Behavioral|healthy lifestyle program|Participants (intervention group) are following a 12 week health promotion program. They will count daily steps by pedometers and participate in weekly organised walks (within socio-cultural organisation)
15909558|NCT03576196|Other|Preoperative Pain Neuroscience Education|"Single session of pain neuroscience education a week prior to surgery, of an individual character, lasting approximately 30 minutes, performed by a physiotherapist trained. The main contents addressed in the educational session were: neurophysiological aspects of pain, biopsychosocial aspects of pain, concept of peripheral and central sensitization, using audio-visual support, examples and metaphors for a better understanding by the patient, as reported in previous studies.
~This treatment was combined with a hand therapy session seven days after the surgery, verbal and written instruction was given to the patients to perform exercises at home of active sliding of the digital flexor tendon, active opposition of the thumb and active range of flexion and extension of the wrist."
15909559|NCT03576196|Other|Usual Care|This treatment was combined with a hand therapy session seven days after the surgery, verbal and written instruction was given to the patients to perform exercises at home of active sliding of the digital flexor tendon, active opposition of the thumb and active range of flexion and extension of the wrist.
15909560|NCT03576183|Biological|VLA1701|VLA1701 is an investigational oral vaccine against LT-ETEC (Labile Toxin-Enterotoxigenic E coli)
15909561|NCT03576183|Biological|Placebo|buffer component of VLA1701
15909562|NCT03576183|Other|Challenge Strain|LSN03-016011/A
15909563|NCT03576170|Other|aromatherapy|aromatherapy by inhalation and/or therapeutic massage
15909564|NCT03576157|Other|Kilkari|Kilkari is an outbound service that delivers weekly, time-appropriate audio messages about pregnancy, childbirth, and childcare directly to families on their mobile phones, starting from the second trimester of pregnancy until the child is one-year-old.
15909565|NCT03576144|Drug|BI 1265162|Multiple rising inhaled doses
15909566|NCT03576144|Drug|Placebo|Multiple rising inhaled doses
15909567|NCT03576131|Biological|GEN1029 (HexaBody®-DR5/DR5)|GEN1029 will be administered intravenously once every 14 days. The dose levels will be determined by the starting dose and the escalation steps taken in the trial.
15909570|NCT03576105|Combination Product|irrigation /sterile saline|mechanical removal of bacteria with sterile saline
15909571|NCT03576105|Combination Product|Conventional methylene blue as photosensitizer|Irrigation with 0,04mL of photosensitizer (0,005%) inside the gingival sulcus around the third molar with pericoronarite for 3 minutes
15909572|NCT03576105|Combination Product|Methylene blue for oral use as photosensitizer|Irrigation with 0,04mL of photosensitizer(0,005%) inside the gingival sulcus around the third molar with pericoronarite for 3 minutes
15909573|NCT03576105|Combination Product|Photodynamic therapy|Red laser for photodynamic therapy (Therapy XT,DMC,Sao Carlos,Sao Paulo,Brazil) Device irradiation with low intensity laser λ = 660 nm, 9J per point and radiant 90 seconds
15909574|NCT03576092|Diagnostic Test|Lung Ultrasound|Lung sonography will be performed on a SonoSite portable ultrasound machine with a C60e 5 - 2 MHx 30cm probe using a modified standard technique examining four lung regions; anterior mid-clavicular high and low on left and right sides, and one on each side posteriorly) in the semi-recumbent position.
15909575|NCT03576079|Device|Laser therapy|epic model biolase with an output of 4W, 1800 J wavelength with a continuous Laser mode.
15909576|NCT03576079|Device|anterior re-positioning splint|hard acrylic anterior re-positioning splint
15909577|NCT03576079|Device|inactive Laser therapy|sham Laser, with inactive beam
15909578|NCT03576066|Drug|ABI-H0731|Participants will receive ABI-H0731 300 mg tablets orally once daily (QD).
15909579|NCT03576066|Drug|SOC NUC|Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.
15909580|NCT03576066|Drug|Placebo Oral Tablet|Participants will receive placebo matching ABI-0731 tablets orally QD.
15909581|NCT03576053|Drug|Lidocaine|Lidocaine intradermal injection
15909582|NCT03576053|Other|Histamine|Skin Prick Test with Histamine
15909583|NCT03576053|Other|Cowhage|Manually skin insertion of cowhage spicules
15909584|NCT03576053|Other|Heat stimulation|Short heat stimulation
15909585|NCT03576053|Other|Pre-heating|Mild skin pre-heating
15909586|NCT03576053|Other|Serotonin|Serotonin electrophoresis
15909587|NCT03576040|Device|Whole Body Dynamic 68Ga-DOTATOC PET/CT|"68Ga-DOTATOC PET-CT will be performed in the nuclear medicine department of the University Hospital of Brest on a Biograph mCT S64 machine (Siemens medical, Erlangen, Germany) Time of Flight system after intravenous injection of 150MBq of 68Ga-DOTATOC. In the usual conditions for performing this exam, the patient must remain at a strict rest for 60 minutes following the injection of the tracer and before a static 3D acquisition. For this protocol, a complementary 4D dynamic acquisition (15-60 minutes post-injection) will be performed during this usual rest period."
15909588|NCT03576027|Other|Hyperbaric Oxygen Therapy|Hyperbaric Oxygen Therapy
15909589|NCT03576014|Biological|BD03|BD03 is to be administered intramuscularly 6 weeks and 2 weeks prior to kidney transplant and 2~4 weeks after the transplant.
15909590|NCT03576001|Drug|Testosterone Undecanoate|administered through injections by study staff
15909591|NCT03576001|Behavioral|hybrid exercise|hybrid exercise: functional electrical stimulation of lower extremity with leg cycling (FES-LC) and arm ergometry, supervised for two weeks and then home-based
15909592|NCT03575988|Other|Diabetes|The patients have diabetes without diabetic retinopathy from the diabetic outpatient
15909593|NCT03575975|Device|Total Ankle Replacement Prosthesis|Comparison of functional range of motion in users of Stryker Scandinavian Total Ankle Replacement (STAR) prosthesis to users of INBONE 2 Total Ankle Replacement prosthesis and to matched controls with intact ankle joints.
15909594|NCT03575962|Drug|GSK3640254 bis-hydrochloride salt capsule|Administered orally (as single dose) on morning of Day 1, as 2 capsules of 100 mg following a moderate calorie and fat meal during Period 1 and Period 2, at the specified sequence, as per study.
15909595|NCT03575962|Drug|GSK3640254 Mesylate Salt Capsule|Administered orally (as single dose) on morning of Day 1, as 2 capsules of , 100 mg following a moderate calorie and fat meal during Period 1 and Period 2, at the specified sequence, as per study.
15909596|NCT03575949|Procedure|Computed Tomography|Undergo FDG PET/CT
15909597|NCT03575949|Other|Fludeoxyglucose F-18|Given IV
15909598|NCT03575949|Procedure|Positron Emission Tomography|Undergo FDG PET/CT
15909599|NCT03575936|Device|Home INR Monitoring|The self-monitoring group will monitor INR at home using the AlereTM Home Monitoring Service. They will call in the weekly results to Alere or submit online via the patient portal, which is the standard protocol among home monitoring patients. Alere will then upload the information to a password-protected HIPAA compliant website that only study investigators will be able to access. Pharmacists will have real-time access to the test results via the web interface. Pharmacists can follow up in real time if the patient forgets to self-test. An alert will also be sent to the pharmacists via email to follow up on any out of range results. This will help streamline pharmacists' workload to dedicate face-to-face time for patients that require such intervention. All home monitoring patients will be seen in clinic by the pharmacist at the end of the 3-month randomization period in order to assess compliance with meter-use and re-evaluate meter-use competency.
15909600|NCT03575936|Procedure|Standard of Care|The patients in the standard of care group will have a clinic visit with the pharmacist at least once every 4 weeks or earlier, as deemed necessary by the pharmacist. The duration of the randomization period will be three months. At the end of the 3-month randomization period, patients will be provided the opportunity to cross over from the home INR monitoring group to the pharmacist-managed clinic group, or vice versa. The remainder of the study duration (post-3 month analysis) will purely be for observational purposes, in order to account for the loss of randomization and potential bias. The total duration of the study will be one year.
15909601|NCT03575923|Behavioral|Urban street greening|The interventions are located on four publicly accessible sites; the total size of the floor area of green space in each of the intervention sites is small, ranging from 0.09 to 0.35 acres. Components of the interventions include tree and flower planting (expected to bloom by March 2018) and artificial tree decorations such as strings of small electric lights and tree socks (the interventions are hereafter collectively referred to as urban street greening). The total cost for all components across all four intervention sites is approximately £6,000, although this excludes artist fees connected to the project. All components of the interventions were implemented within a one week period in November 2017 by two arborists, two local artists, staff members at Southway Housing Trust, and local community members from Old Moat and a local school.
15909602|NCT03575897|Diagnostic Test|Assessment of infant body composition|Serial assessments of infant body composition with air displacement plethysmography in very preterm infants will occur in the first 14 days after birth (baseline measure), at 32 weeks postmenstrual age (PMA), and at 36 weeks PMA or hospital discharge (whichever occurs first)
15909603|NCT03575884|Behavioral|Screen Time Reduction Curriculum|"Fit5Kids classroom curriculum, weekly parent newsletters, in-person (or by telephone) goal setting on their child's screen time, a lending library of resources (books, games, arts/crafts, etc), and text messages on screen time parenting practices offered over 7-8 weeks in the Fall semester. The classroom component will be taught by bilingual (English/Spanish) research staff interventionists. Parent newsletters, goal setting, and text messages will be offered in English and Spanish per parent preference. There will also be two booster weeks of classroom activities, daily parent newsletters, goal setting, and daily text messages on screen time parenting practices offered during the booster weeks in the Spring semester. The lending library of resources for parents/children will be available throughout the entire school year."
15909604|NCT03575871|Drug|PF-04965842 100 mg|PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 12 weeks
15909605|NCT03575871|Drug|PF-04965842 200 mg|PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 12 weeks
15909606|NCT03575871|Drug|Placebo|Placebo, administered as two tablets to be taken orally once daily for 12 weeks
15909607|NCT03575858|Device|Barrel shaped interdental brush|Barrel shaped interdental brush Size SS 0.8mm
15909608|NCT03575858|Device|Tapered interdental brush|Tapered interdental brush Size SS 0.6mm
15909609|NCT03575845|Behavioral|Occupational Therapy Informed Yoga|Occupational therapy informed yoga met weekly for six, 60-minute sessions. Each session started with a seated warm-up to coordinate breath and movement and promote upper extremity mobility. Standing postures followed to target balance. Sessions closed with restorative postures in seated and supine variations.
15909610|NCT03575832|Other|Counseling|Complete nutrition counseling sessions
15909611|NCT03575832|Other|Informational Intervention|Receive an exercise plan and printed materials
15909612|NCT03575832|Other|Quality-of-Life Assessment|Ancillary studies
15909613|NCT03575832|Other|Questionnaire Administration|Ancillary studies
15909614|NCT03575832|Behavioral|Telephone-Based Intervention|Receive telephone coaching calls
15909615|NCT03575819|Drug|FOR46|FOR46 is an intravenously (IV) administered antibody-drug conjugate (ADC) directed against CD46
15909616|NCT03575806|Combination Product|TACE plus autologous Tcm immunotherapy|"TACE:transcatheter arterial chemoembolization.
~Autologous Tcm immunotherapy: to collect patient's own immune cells and then given back to the patient after amplified in vitro."
15909617|NCT03575806|Procedure|TACE|TACE:transcatheter arterial chemoembolization.
15909618|NCT03575793|Drug|Nivolumab|A fully human immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed death-1 (PD-1,PCD-1,) with immune checkpoint inhibitory and antineoplastic activities.
15909619|NCT03575793|Drug|Plinabulin|Plinabulin (BPI-2358) is a synthetic, low molecular weight, new chemical entity originally developed by Nereus Pharmaceuticals, Inc., and now by BeyondSpring Pharmaceuticals, Inc. It belongs to the diketopiperazine class of compounds with a chemical name 2, 5-piperazinedione, 3-[[5-(1,1-dimethylethyl)-1H-imidazol-4-yl[methylene]-6-(phenylmethylene)-, (3Z,6Z) (trivial name t-butyl-dehydrophenylahistin).
15909620|NCT03575793|Drug|Ipilimumab|Ipilimumab is a monoclonal antibody that works to activate the immune system by targeting CTLA-4, a protein receptor that downregulates the immune system.
15909621|NCT03575780|Drug|KX2-391 Ointment 1%|The experimental drug, KX2-391 Ointment 1% will be used in subjects with Clinically typical Actinic Keratosis on the face or balding scalp.
15909622|NCT03575767|Other|Myeloablative Hematopoietic Stem Cell Transplantation|Myeloablative hematopoietic stem cell transplantation from many kinds of donors, including matched related donor, matched unrelated donor, haploidentical related donor.
15909623|NCT03575754|Device|Percutaneous Ultrasound Gastrostomy|A balloon catheter is inserted into the stomach and used to appose tissue between anterior stomach and skin. Fluid fills the balloon, enabling ultrasound visualization. Then a guidewire is inserted, and pulled out through the mouth to create wire-to-wire (through and through) access. At that point, a gastrostomy tube is placed over it using over-the-wire (push) technique.
15909624|NCT03575741|Diagnostic Test|Balance Tests|"Following balance exercises will be performed by the participants:
~Bipedal, hip wide stand, eyes open and hands on hips, 60sec
~Bipedal, hip wide stand, eyes closed, hands on hips, 30sec
~Tandem-stand, eyes open, hands on hips, 60sec (front foot chosen by participant)
~Tandem-stand, eyes closed, hands on hips, 30sec (same front foot)
~One-leg-stand, eyes open, hands on hips, 30sec (randomized supporting leg)
~One-leg-stand, eyes open, hands on hips, 30sec (other leg)
~Bipedal, hip wide stand, eyes open, hands on hips, counting backwards in steps of two (367 - 365 - 363 - ...), 60sec
~The rest between the trials will last for at least 30sec, but can be extended by the participants as long as they want. The overall measurement will not exceed 30 minutes."
15909625|NCT03575728|Other|MyChart-MHT|All participants in this study will receive targeted psycho-educational interventions from time to time based on symptom severity reports as determined by the software algorithm
15909626|NCT03575715|Device|EBUS|EBUS is performed using an endoscope ultrasound system , which is equipped with a 20-MHz mechanical radial-type probe (UM-S20-17S;Olympus) with an external diameter of 1.4 mm and a GS (K-201; Olympus).
15909627|NCT03575702|Drug|Uritos®|film-coated tablets 0.1 mg
15909628|NCT03575702|Drug|Urotol®|film coated tablets, 2 mg
15909629|NCT03575689|Device|Doyle Splint|Using Doyle splints following septoplasty is the standard of care and may help with stability of the septum in the immediate post op period. owever these splints are associated with morbidity in the post-op period. The quilting technique was developed to prevent complications and stabilize the septum. This study examines the efficacy of these splints in stabilizing the septum and preventing complications after septoplasty
15909630|NCT03575676|Drug|SOM3355 100mg BID|Oral
15909631|NCT03575676|Drug|SOM3355 200mg BID|Oral
15909632|NCT03575676|Drug|Placebo BID|Oral
15909633|NCT03575663|Diagnostic Test|Indirect bronchial challenge|Mannitol dry powder inhalation
15909634|NCT03575663|Other|Sham bronchial challenge|Mock dry powder inhalation
15909696|NCT03575156|Biological|blood sample|36 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
15909635|NCT03575650|Other|Cardiac imaging modalities|Repeat cardiac echocardiographies, MRI-scans and CT-scans for early subclinical biomarker assessments in breast cancer patients treated with chemotherapy and radiotherapy
15909636|NCT03575637|Drug|Olanzapine|Patients who have failed first-line treatment of advanced gastric cancer receive second-line treatment with paclitaxel regimen and olanzapine 5 mg QD.
15909637|NCT03575624|Behavioral|Nutritional and goal-setting education, yoga|"This integrative program series, Live Well, was delivered bi-weekly from January-May 2017, by an interdisciplinary team of a registered nurse, occupational therapist/researcher, registered dietitian, and certified yoga instructor.
~Session experiences were designed to build:
~Sisterhood for health promotion and support, Individual and group health promotion through goal-setting, Healthy family nutrition and meal planning skills , Family integrated yoga practice"
15909638|NCT03575611|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15909639|NCT03575598|Drug|Sitravatinib|Sitravatinib (MGCD516) is an orally-available, potent small molecule inhibitor of a closely related spectrum of tyrosine kinases, which has shown antitumor activity in a variety of in vitro and in vivo model systems.
15909640|NCT03575598|Biological|Nivolumab|Nivolumab (OPDIVO®) is a human IgG4 kappa immunoglobulin that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.
15909641|NCT03575585|Behavioral|BEST assessment only|Patients complete the BEST assessment, a self-report measure containing questions about patients' substance use, sexual risk behaviors, and partner risk levels.
15909642|NCT03575585|Behavioral|BEST assessment plus feedback report|Patients complete the BEST assessment, a self-report measure containing questions about patients' substance use, sexual risk behaviors, and partner risk levels. Based on their responses they also receive a personalized feedback report that .provides individualized risk levels in five behavior domains: 1) number of partners, 2) riskiness of partners, 3) condom use, 4) riskiness of sex acts, and 5) sex under the influence of drugs or alcohol.
15909643|NCT03575585|Behavioral|Standard Counselor Training|2 hours of training on how to use the BEST patient feedback report
15909644|NCT03575585|Behavioral|Enhanced Counselor Training|Standard training (2 hrs) plus 8 additional hours (4 modules) of motivation/skills training on a) talking about sex with patients, b) basics of using Motivational Interviewing techniques to review a feedback report, c) teaching patients problem solving skills, and d) teaching patients relationship communication skills.
15909645|NCT03575572|Drug|Colchicine|Colchicine is an alkaloid approved in 1961 for the use in Familial Mediterranean Fever in adults and children 4 years of age or older. It has been widely used for decades in other indications, such as Gout, recurrent pericarditis, pericardial effusions and other inflammatory diseases. This drug is commercially available and is approved in children 4 years and older.
15909646|NCT03575559|Behavioral|Individual planning|Each participant forms up to three action and up to three coping plans individually, without consulting the participating friend, but discussing the plans with the experimenter. CONTENT: The planning materials and forms have the following sections: (a) information on the importance of planning (b) instructions of what should be included in a good plan (the when, where, and how components), (c) formulating action and coping plans based on the if-then structure. Action plans (referring to when, when, and how the individual will act) as well as coping plans (referring to how to overcome potential difficulties, risky situations or temptations to not engage in physical activity).
15909647|NCT03575559|Behavioral|Collaborative planning|Both friends together create up to three if-then plans on when, where, and how both will implement PA together. In addition, up to three coping plans will be formed together. This jointly developed plan is discussed with the experimenter. CONTENT: The planning materials and forms have the following sections: (a) information on the importance of planning (b) instructions of what should be included in a good plan (the when, where, and how components), (c) formulating action and coping plans based on the if-then structure. Action plans refers to when, when, and how the individual will act) as well as coping plans (referring to how to overcome potential difficulties, risky situations or temptations to not engage in PA). All materials are formulated using the plural.
15909648|NCT03575559|Behavioral|Education and motivation treatment|Adolescents will watch a movie from the Federal Office of Public Health Switzerland including the guidelines of physical activity (PA) for adolescents. All adolescents respond to a quiz afterwards. After the quiz, the experimenter repeats the guidelines for PA based on a brochure that all adolescents can take home with them. In addition, the experimenter asks for barriers and benefits of PA the adolescents perceive. Next to it, the experimenter explains that a weight gain might be possible due to PA in the beginning. Furthermore, the experimenter presents how the data of the accelerometer should look like if one is sufficiently physical active. As a last part self-efficacy as an important aspect of goal success is mentioned. The materials exclude any planning statements.
15909649|NCT03575533|Diagnostic Test|Bayesian network 'Sherlock'|Primary objective is to validate the Bayesian Hemodynamics model 'Sherlock'. Criterion for validation is a match between Sherlock's estimate of the Hemodynamic status of a patient and a ground truth based on a cardiologist's judgement.
15909650|NCT03575520|Drug|Pegfilgrastim|A fixed dose of 6.0 mg pegteograstim was administered subcutaneously on day 2 of each chemotherapy cycle (between 22 and 26 hours after the completion of chemotherapy).
15909651|NCT03575520|Drug|Doxorubicin/Cyclophosphamide(AC) treatment|"doxorubicin 60mg/m2 IV every 2 weeks cyclophosphamide 600mg/m2 IV every 2 weeks
~Four cycles of dose dense AC treatment will be given every 2 weeks."
15909652|NCT03575507|Device|Treatment with BTL EMSCULPT device.|The treatment administration phase will consist of four (4) treatments, delivered twice a week. The applicator will be applied over the buttock area. Visible contractions will be induced by the device.
15909653|NCT03575494|Other|Intraoral and Radiographic Dental Examination|(ORTHOPANTOMOGRAPH® OP300 PANORAMIC, Instrumentarium Dental, Tuusula, Finland,63 kVp, 0.8 mA, 0.5 s).
15909654|NCT03575481|Diagnostic Test|The RAT and The TST|The RAT (ReoGo; Motorika Medical, Caesarea, Israel) The TST protocol included the conventional, repetitive, task-oriented training of the affected arm.
15909697|NCT03575156|Biological|urine sample|6 ml
15909698|NCT03575130|Drug|Ripasudil eye drops|Rho-kinase-Inhibitor (IMP)
15909699|NCT03575130|Drug|Optive eye drops|Artificial tears (placebo)
15909700|NCT03575130|Procedure|Descemetorhexis|Corneal endothelial cells are removed prior to IMP administration by Descemetorhexis.
15909739|NCT03574844|Dietary Supplement|Placebo|Placebo comparator arm
15909655|NCT03575468|Behavioral|Enhanced E-cigarette Coaching|The EEC intervention calls will include assessment of e-cigarette use and discussion about how and why e-cigarettes are being used on every call. In addition to the standard quitline cessation program, the enhanced program will include education (via quit coaches and two tailored quit guides), behavioral support tailored to dual users, and shared decision making strategies to address how and why FDA-approved quitting aids and ENDS are being used and to develop an integrated quit plan based on callers' decisions.
15909656|NCT03575468|Behavioral|Quitline treatment as usual|The standard tobacco quitline program is a proactive 5-call intervention grounded in social cognitive theory and the U.S. Public Health Service clinical practices guidelines for treating tobacco use and dependence. All enrollees in the study are eligible for 2-8 weeks of nicotine replacement therapy (depending on their standard quitline benefit offering), if they medically qualify and/or return a medical override letter from their doctor.
15909657|NCT03575455|Behavioral|Exercise|HR-controlled treadmill walking
15909658|NCT03575442|Behavioral|"3 session program of art therapy"|With this program, we expect to offer socio-emotional well-being in the psychiatric context, and creative self-expression through painting. In addition, we hope to provide contributions towards the creation of quality standards of the professional practice of nurses, within the context of implementing psychosocial programs in mental health.
15909659|NCT03575429|Behavioral|Engagement Intervention|"Family navigators will use MI to engage families to decrease resistance and build motivation and commitment to challenging behavior changes by eliciting and reflecting broader goals and values, linking those values to specific behavior change, and negotiating a menu of options for change based on individual preferences. PSE will be used by the Family Navigators to guide families in selecting an objective, measurable problem, then proceed through a series of steps that involve goal setting, brainstorming and evaluating solutions, choosing a solution, and action planning."
15909660|NCT03575429|Behavioral|Engagement + Coaching Intervention|ESI program planning entails identifying goals and objectives for the child and teaching strategies and supports for parents. Each session includes the following components: 1) setting the stage to develop that visit's agenda and gather updates; 2) intervention implementation that must include the following steps to coach the parent: a) review the objective, b) use modeling, guided/caregiver practice, or video review to teach the strategy, c) provide specific feedback to the parent, and d) problem solving and plan for next time; steps a-d are repeated for 3-5 activities per session; and 3) summarize plans for parent implementation between sessions. Families are invited to Autism Navigator How-To Guide for Families, a self-guided web-based course, with an online weekly group meeting.
15909661|NCT03575403|Drug|Alcohol|In each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.
15909662|NCT03575403|Drug|Placebos|Subjects will receive placebo capsules.
15909663|NCT03575403|Drug|Duloxetine|Subjects will receive duloxetine capsules.
15909664|NCT03575403|Drug|Methylphenidate|Subjects will receive methylphenidate capsules.
15909665|NCT03575390|Dietary Supplement|Placebo|The gel contains a mixture of glucose and maltodextrin - a complex carbohydrate - along with fat and a trace of protein.
15909666|NCT03575390|Dietary Supplement|Pomegranate|Pomegranate extract 500mg
15909667|NCT03575377|Other|Disposal Aid|Deterra® drug deactivation system
15909668|NCT03575364|Device|ClotTriever|Thrombectomy
15909669|NCT03575351|Drug|Standard of Care|Standard of Care
15909670|NCT03575351|Genetic|JCAR017|JCAR017
15909671|NCT03575338|Procedure|Open Scarf Osteotomy|Open Scarf Osteotomy
15909672|NCT03575338|Procedure|Minimally invasive scarf Osteotomy|Minimally invasive scarf Osteotomy
15909673|NCT03575325|Drug|CPX-351|The infusion of CPX-351 (cytarabine:daunorubicin) Liposome Injection will be performed through a central venous catheter, using an infusion pump to ensure that the drug is infused over the specified time period.
15909674|NCT03575312|Drug|Enrofloxacin|dermal application, inhalation rsp. oral administration of Enrofloxacin
15909675|NCT03575299|Biological|The adoptive treatment of allogeneic γδT cells|Allogeneic γδT cells will be administered to patients with MDR-TB every two weeks, for 12 times in a total of 6 months.
15909676|NCT03575299|Other|Control|No allogeneic γδT cells will be administered to patients with MDR-TB.
15909677|NCT03575299|Drug|Conventional treatment|Patients will be treated with anti-tuberculosis drugs throughout the entire process of the study.
15909678|NCT03575286|Diagnostic Test|Pregnancy test|Detects hormone (hCG, Human Chorionic Gonadotropin) produced by the body during pregnancy
15909679|NCT03575273|Behavioral|Sniffin' Sticks Odor Identification and Hedonic Scale|This task measures odor identification accuracy and perceived pleasantness of odors.
15909680|NCT03575273|Behavioral|Sucrose Taste Preference Assessment|This task measures participant ratings of sucrose preference.
15909681|NCT03575273|Behavioral|Food Preferences Task|Participants rate images of various food stimuli. Variables derived include relative preferences and reaction time (in milliseconds).
15909682|NCT03575273|Behavioral|Progressive Ratio (PR) Task|In the PR task, the subject is required to make an increasing number of operant responses for each successive reward
15909683|NCT03575273|Procedure|Clinical Electrophysiology|To examine motivated attention in response to food stimuli, brain electrophysiology via event related potentials (ERPs) will be assessed while participants view and rate images of food and non-food items.
15909684|NCT03575273|Dietary Supplement|Standardized Meal and Hunger and Satiety Ratings|Participants will receive a standardized meal and complete hunger and satiety ratings.
15909685|NCT03575247|Drug|Glucocorticoids|Long-term use of glucocorticoids
15909686|NCT03575234|Drug|Cyclophosphamide|Given IV
15909687|NCT03575234|Biological|IRX-2|Given SC
15909688|NCT03575234|Biological|Nivolumab|Given IV
15909689|NCT03575234|Procedure|Surgery|Undergo surgery
15909692|NCT03575195|Drug|Rifaximin|Rifaximin 550mg orally
15909693|NCT03575195|Other|Placebo|Placebo control
15909694|NCT03575182|Other|Gait retraining program|Supervised gait retraining with verbal and real-time visual feedback.
15909695|NCT03575169|Device|BIS Monitor|Unilateral BIS electrode
15909740|NCT03574831|Device|Stretta|Stretta
15909701|NCT03575117|Behavioral|Common-Sense Model (CSM) Be Well|Theoretically informed text messages and images that cover how physical activity is linked to decreasing colorectal cancer risk.
15909702|NCT03575117|Behavioral|ACS usual messages|Information distributed by the American Cancer Society as information on the link between physical activity and cancer risk (source: www.cancer.org)
15909703|NCT03575117|Behavioral|NCI HealthyYouTXT--Get Active (HYT--GA)|Text messaging program developed by National Cancer Society (NCI). It is a free SMS program that promotes physical activity.
15909704|NCT03575104|Drug|ACT-541468|Administered orally as tablets.
15909705|NCT03575104|Other|Placebo|Administered orally as tablets.
15909706|NCT03575091|Other|Non-individualized|Comparing two experimental interventions with standard care
15909707|NCT03575091|Other|Individualized|Comparing two experimental interventions with standard care
15909708|NCT03575078|Drug|ARQ761, Olaparib|ARQ761: weekly infusion. Olaparib Dose 1 D-7 administered orally twice daily
15909709|NCT03575065|Drug|BGB-290|Administered orally
15909710|NCT03575052|Drug|Pimavanserin|Pimavanserin 34 mg total daily dose, tablets, once daily by mouth (provided as two 17 mg NUPLAZID® tablets)
15909711|NCT03575052|Drug|Placebo|Placebo, tablets, once daily by mouth (provided as two placebo tablets)
15909712|NCT03575039|Device|VitaFlow II Transcatheter Aortic Valve System|VitaFlow II Transcatheter Aortic Valve System contains a Valve stent -VitaFlow Aortic Valve, a Delivery system-VitaFlow II Delivery System and a Introducer set
15909713|NCT03575026|Behavioral|Music-with-movement|Subjects will listen their preferred music and move their body actively with music
15909714|NCT03575026|Behavioral|Usual care|Social activity acts as control with similar dose and intensity with intervention arm
15909715|NCT03575013|Drug|Avelumab|Avelumab is a fully human anti-programmed death ligand 1 (PD-L1) IgG1 antibody
15909716|NCT03575013|Drug|Docetaxel|Docetaxel is a antineoplastic agent belonging to the taxoid family
15909717|NCT03575000|Drug|Bromocriptine|This is an open-label study, so there is no comparator group. As such there is only one arm. Subjects will receive bromocriptine at a starting dose of 2.5mg daily which will be increased, if tolerated, to 5mg daily after one week. Bromocriptine will be continued for a total of 6 weeks. Laboratory investigations, telephonic interviews, and face to face visits with subjects will be conducted before, during, and after the time period that bromocriptine will be used as detailed in the study design section.
15909718|NCT03574987|Other|Diet|Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated
15909719|NCT03574974|Device|Experimental Feedback|"Feedback is presented in the form of a line graph that is updated every 2 seconds throughout the scan to indicate activity in the target area. A red diamond will indicate periods of symptom provocation, during which participants are exposed to symptom-provoking auditory stimuli in the form of personalized trauma scripts and sound clips. A blue arrow will indicate periods of down-regulation, where participants will try to bring the feedback line down as much as possible (by trying to decrease their fear/anxiety). The investigators believe that this feedback may help participants learn to control their PTSD symptoms.
~Participants will attend a total of 18 feedback scans over the course of 3 sessions."
15909720|NCT03574974|Device|Control Feedback|"Feedback is presented in the form of a line graph that is updated every 2 seconds throughout the scan to indicate activity in the target area. A red diamond will indicate periods of symptom provocation, during which participants are exposed to symptom-provoking auditory stimuli in the form of personalized trauma scripts and sound clips. A blue arrow will indicate periods of down-regulation, where participants will try to bring the feedback line down as much as possible (by trying to decrease their fear/anxiety). The investigators do not believe this feedback can help participants' PTSD symptoms.
~Participants will attend a total of 18 feedback scans over the course of 3 sessions."
15909721|NCT03574961|Behavioral|e-Support group|Online (remote), web-based support group via private video link.
15909722|NCT03574961|Behavioral|e-Journaling placebo|Online journaling activity.
15909723|NCT03574948|Drug|5-HTP|8 weeks active substance 5-HTP (2 x 100mg per day)
15909724|NCT03574948|Drug|Placebo oral capsule|8 weeks placebo (2 x 1 caps per day)
15909725|NCT03574935|Drug|External Chinese medicine|"External Chinese medicine:
~For patients in the treatment group, they will accept one of three specific External Chinese medicine according to their lesions and corresponding syndromes:
~Chinese herb of Clear heat-Remove dampness-Detoxicate for patients belong to heat syndrome;
~Chinese herb of Activating blood-Removing stasis for patients belong to stasis syndrome;
~Chinese herb of Supplement deficiency-Generate muscles for patients belong to deficiency syndrome."
15909726|NCT03574935|Drug|External Western medicine|"For patients in the control group, they will accept one of three specific external Western medicine according to their lesions:
~1.Ethacridine Lactate Solution(lesions with much effusion)； 2.1% Sulfadiazine Silver Cream（lesions with infection）； 3.rb-bFGF(lesions with no slough and look clear)."
15909727|NCT03574922|Other|Balance exercises|Balance Exercises
15909728|NCT03574922|Other|Core Stabilization exercises|Core Stabilization exercises
15909729|NCT03574909|Drug|Aspirin|Tromalyt® 150mg prolong release capsule for oral ingestion. The capsule contains 150mg of anti-platelet agent acetylsalicylic acid, maize starch and Sucrose 20:80. The capsule also contains Copovidone (Kollidon VA-64), Eudragit L, Ethylcellulose and Triacetin. The capsule is made with gelatin, erythrosine, quinoline yellow, titanium dioxide.
15909730|NCT03574909|Drug|Placebos|Size 0 hard gelatin capsules containing 99% of microcrystalline cellulose and 1% of magnesium stearate (Sanitatis®). The capsules contain 198mg microcrystalline cellulose and 2mg of magnesium stearate
15909731|NCT03574896|Other|Computer model predictions of acute kidney injury|Comparison of the performances of AKIpredictor and physicians in predicting AKI stage 2 or 3 in the 7 days following ICU admission
15909732|NCT03574883|Device|tACS|tACS is a non-invasive stimulation technique that works by delivering a weak sinusoidally oscillating electrical current to the surface of the skull to entrain oscillations in the brain.
15909733|NCT03574883|Device|tDCS|tDCS is a form of neuromodulation method where very low levels of constant current are delivered to specifically targeted areas of the brain
15909734|NCT03574870|Device|wearable sensor|A commercially-available wearable fitness sensor
15909735|NCT03574857|Drug|Metolazone Oral Tablet|Day 1: Metolazone 5 mg PO Day 2: Metolazone 5 mg PO
15909736|NCT03574857|Drug|Chlorothiazide Injection|Day 1: Chlorothiazide 500 mg IV Day 2: Chlorothiazide 500 mg IV
15909741|NCT03574818|Drug|Necitumumab-Gemcitabine-Cisplatin|"Gemcitabine 1250mg/m2 IV on D1, D8
~Cisplatin 75mg / m2 IV on D1
~Necitumumab 800mg IV on D1, D8 (peripheral blood for effector cells and cytokine measurements prior to each cycle) Repeat cycle every 21 days up to 3 cycles."
15909742|NCT03574818|Diagnostic Test|Evaluation to determine if patient is a candidate to proceeed with surgical resection or not|Patients will be evaluated with repeat imaging studies (PET/CT or CT Chest, Abdomen, Pelvis) and will be re-evaluated for surgical resection. Patients who had progressive disease or are NOT a surgical candidate will come off the study and will be treated according to standard therapies. All patients will be followed up for 2-year disease-free survival and overall survival
15909743|NCT03574805|Drug|PRS-060|Study drug
15909744|NCT03574805|Drug|Placebo|Inhalant designed to mimic PRS-060
15909745|NCT03574792|Drug|Gabapentin|Given PO
15909746|NCT03574792|Drug|Methadone|Given PO
15909747|NCT03574792|Drug|Oxycodone|Given PO
15909748|NCT03574792|Other|Quality-of-Life Assessment|Ancillary studies
15909749|NCT03574792|Other|Questionnaire Administration|Ancillary studies
15909750|NCT03574792|Drug|Venlafaxine|Given PO
15909751|NCT03574792|Drug|Venlafaxine Hydrochloride Extended Release|Given PO
15909752|NCT03574779|Drug|Niraparib|Niraparib is a potent, orally active PARP1 and PARP2 inhibitor being developed as a treatment for participants with tumors that harbor defects in the homologous recombination deoxyribonucleic acid (DNA) repair pathway or that are driven by PARP-mediated transcription factors.
15909753|NCT03574779|Drug|TSR-042|TSR-042 is a humanized monoclonal antibody that binds with high affinity to Programmed cell death protein 1 (PD-1) resulting in inhibition of binding to programmed death receptor ligands 1 and 2 (PD-L1 and PD-L2).
15909754|NCT03574779|Drug|Bevacizumab|Bevacizumab is an Food Drug and Administration (FDA) approved antiangiogenic recombinant humanized monoclonal Immunoglobulin (Ig) G1 antibody against the vascular endothelial growth factor protein, which has been shown to be efficacious against a variety of different cancer types, including colon cancer, lung cancer, glioblastoma, and renal-cell carcinoma.
15909755|NCT03574766|Behavioral|Meditation|Daily meditation
15909757|NCT03574740|Other|Tobacco Smoking|Influence of Tobacco Smoking on the development of OSA
15909758|NCT03574727|Procedure|Injection to or release of anterior cutaneous nerves|Patients who have undergone at least one injection to the nerves
15909759|NCT03574714|Other|Extracellular pH|Extracellular pH gradient
15909760|NCT03574701|Dietary Supplement|Vitamin A|The use of Vitamin A , in the treatment of olfactory loss has been previously studied in both animals and humans. These studies have shown promising results in the treatment of olfactory loss.
15909761|NCT03574688|Dietary Supplement|Water|Increased daily water intake with 1.5 Liters of water per day on top of habitual water intake.
15909762|NCT03574675|Device|Simulated Altitude (FiO2: 15.1)|"Inhalation of deoxygenated air through an altitude simulator (Altitrainer) for approximately 1 hour given by a facemask."
15909763|NCT03574675|Device|Shamed Hypoxia (FiO2: 20.9)|"Inhalation of unmodified air through an altitude simulator (Altitrainer) for approximately 1 hour given by a facemask."
15909764|NCT03574662|Other|Frailty assessment|This assessment consists of a combination of gait speed measurement via infrared sensors as well as a grip strength assessment. Patients will then attend cardiac rehabilitation for an abbreviated six week program.
15909765|NCT03574662|Other|Quality of life assessment|This assessment consists of two questionnaires, Kansas City Cardiomyopathy Questionnaire and Minnesota Living with Heart Failure questionnaire. Patients will then attend cardiac rehabilitation for an abbreviated six week program.
15909766|NCT03574649|Drug|Nab-paclitaxel|5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine
15909767|NCT03574649|Drug|Cisplatin|(SP-4-2)-diamminedichloroplatinum(II)
15909768|NCT03574649|Drug|5Fluorouracil|5-fluoro-2,4 (1H,3H)-pyrimidinedione
15909769|NCT03574649|Drug|Cyclophosphamide|2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
15909770|NCT03574649|Biological|ETBX-011|adenovirus serotype-5 [Ad5] [E1-, E2b-]-carcinoembryonic antigen [CEA] vaccine
15909771|NCT03574649|Biological|ETBX-051|Ad5 [E1-, E2b-]-Brachyury vaccine
15909772|NCT03574649|Biological|ETBX-061|Ad5 [E1-, E2b-]-mucin 1 [MUC1] vaccine
15909773|NCT03574649|Biological|GI-4000|RAS yeast vaccine
15909774|NCT03574649|Biological|GI-6301|Brachyury yeast vaccine
15909775|NCT03574649|Drug|Aldoxorubicin|INNO-206
15909776|NCT03574649|Drug|Avelumab|Fully human anti-PD-L1 IgG1 lambda monoclonal antibody
15909777|NCT03574649|Drug|ALT-803|recombinant human super agonist interleukin-15 (IL-15) complex [also known as IL-15N72D:IL-15RαSu/IgG1 Fc complex]
15909778|NCT03574649|Biological|haNK|NK-92 [CD16.158V, ER IL-2], Suspension for Intravenous [IV] Infusion (haNK™ for Infusion)
15909779|NCT03574649|Drug|Docetaxel|Docetaxel
15909780|NCT03574649|Drug|carboplatin|carboplatin
15909781|NCT03574636|Device|OCT guidance|OCT guide stent implantation
15909782|NCT03574636|Device|IVUS guidance|IVUS guide stent implantation
15909783|NCT03574636|Device|QCA|QCA guide stent implantation
15909784|NCT03574623|Device|Electrical Stimulator|An electrical stimulator will be used to deliver electrical current through surface electrodes to produce hand opening by making the paretic finger and thumb extensor muscles contract. The stimulator can be programmed to turn on and off in a repetitive cyclic fashion (i.e., cNMES) or be programmed to deliver stimulation with an intensity that corresponds to the opening of a glove instrumented with sensors and plugged into the stimulator (i.e., CCFES).
15909785|NCT03574623|Behavioral|Occupational Therapy|Task practice that requires movement and use of the paretic hand under the guidance of a trained therapist.
15909829|NCT03574389|Biological|Hib|suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
15909856|NCT03574103|Behavioral|Caloric restriction only|Participants in this group will receive a eating plan with caloric restriction (513 to 770 kcal from estimated energy requirements), without restriction in time for feeding, for 8 weeks.
15909888|NCT03573947|Drug|Paclitaxel|80 mg/m2 on days 1 and 8 of every 21-day treatment cycle
15909889|NCT03573934|Other|GLP-2|GLP-2
15909786|NCT03574610|Device|Transcranial Rotating Permanent Magnet Stimulator (TRPMS)|"TRPMS is a wearable non-invasive transcranial rotating permanent magnet stimulator. It has been determined to be a Non Significant Risk device by the FDA.
~The amount and frequency of therapy are prescribed by the physician, and the device is custom configured to the patient to deliver the required amount of treatment. The device does not turn on until it is time for the treatment. It consists of three main parts: Neoprene cap with microstimulator(s), stimulator console (device controller box) and the tablet with TRPMS app which activates the console. The neoprene cap prevents the microstimulator(s) from coming in direct contact with the scalp. Microstimulators deliver the magnetic stimulation to the brain based on a prescription program uploaded in the stimulator controller."
15909787|NCT03574597|Drug|Semaglutide|Semaglutide will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Subjects will start semaglutide treatment at 0.24 mg; dose will gradually be increased every 4 weeks up to 2.4 mg.
15909788|NCT03574597|Drug|Placebo (semaglutide)|Placebo will be injected into a skin fold, in the stomach, thigh or upper arm once a week at the same day of the week (to the extent possible) throughout the trial. Participants will receive placebo at an equivalent dose to semaglutide.
15909789|NCT03574584|Drug|NNC0165-1562|Participants will receive NNC0165-1562 subcutaneous (s.c., under the skin) injection(s) once-weekly for 20 weeks. The dose will be escalated over 16 weeks to a final dose level that will be maintained for 4 weeks.
15909790|NCT03574584|Drug|Semaglutide|Participants will receive semaglutide s.c. injection(s) once-weekly for 20 weeks. The dose will be escalated over 16 weeks to a final dose level that will be maintained for 4 weeks.
15909791|NCT03574584|Drug|Placebo (NNC0165-1562)|Participants will receive placebo (NNC0165-1562) s.c. injection(s) once-weekly for 20 weeks.
15909795|NCT03574558|Device|MD-Logic Switch Advisor|Study algorithm will be used in order to determine the initial pump setting/ MDI dosing while switching from from MDI to pump therapy or vice versa
15909797|NCT03574519|Behavioral|Non-contingent incentives|Incentives are provided for participation
15909798|NCT03574519|Behavioral|Contingent incentives|Incentives are provided for attaining daily goals
15909799|NCT03574519|Behavioral|Weekly feedback|Text message feedback is delivered weekly summarizing the past week's progress
15909800|NCT03574519|Behavioral|Daily feedback|Text message feedback is delivered daily summarizing the current day's progress
15909801|NCT03574493|Procedure|TME with LAR|Several surgical techniques are used to perform TME. Dissection using open laparotomy and minimally-invasive laparoscopic or robot-assisted abdominal approaches is performed in a 'top-down' manner, where the instruments are inserted transabdominally and the procedure progresses from splenic flexure/sigmoid colon mobilization to rectal resection. A transanal approach may also be used, a 'bottom-up' procedure where instruments are inserted through the anus to perform rectal resection and TME
15909802|NCT03574480|Behavioral|Intervention (training in use of a Smartphone application)|The intervention group will be added a training for 3 months in use of a Smartphone application, designed to promote a healthy diet, increased physical acivity and decreased sedentary.
15909803|NCT03574480|Behavioral|Control (Advice on healthy diet and physical activity recommendations)|Advice on healthy diet and physical activity recommendations
15909804|NCT03574467|Behavioral|Bobath Neurodevelopmental Treatment Approach|The Bobath Neurodevelopmental Treatment (NDT) rehabilitation approach is effective in increasing the functional capacity and acquiring independence in patients with stroke and brain tumor.
15909805|NCT03574454|Other|Machine Learning (ML)|Application of ML support algorithm to accelerate and enhance human interpretation of WB-MRI scans in patients with myeloma
15909806|NCT03574441|Device|Tegaderm dressing + catheter support pad|Tegaderm TM is a transparent tape. This intervention adds a support pad that comes in the epidural kit to help secure the catheter
15909807|NCT03574441|Device|Tegaderm dressing + Steri-strip dressing|Tegaderm TM is a transparent tape. This intervention adds Steri Strips TM of tape to help secure the catheter
15909808|NCT03574441|Device|Tegaderm dressing only|Tegaderm TM is a transparent tape. This intervention uses only Tegaderm to secure the catheter
15909809|NCT03574428|Drug|GNbAC1|Monoclonal Antibody infused i.v.
15909810|NCT03574428|Other|GNbAC1 Placebo|Equivalent to GNbAC1 Buffer
15909811|NCT03574415|Drug|DWP14012|DWP14012 tablets
15909812|NCT03574415|Drug|Placebo|DWP14012 placebo-matching tablets
15909813|NCT03574402|Drug|Avitinib Maleate|300mg orally (PO) twice daily (BID) on day 1-28.
15909814|NCT03574402|Drug|Afatinib|40mg orally once a day, 28 days as one cycle.
15909815|NCT03574402|Drug|Crizotinib|250mg PO QD on days 1-28. 28 days as one cycle.
15909816|NCT03574402|Drug|X-396|225mg PO QD on days 1-28. 28 days as one cycle.
15909817|NCT03574402|Drug|Chidamide|30mg orally twice weekly, 28 days as one cycle.
15909818|NCT03574402|Drug|Pyrotinib Maleate|400mg PO QD on days 1-28. 28 days as one cycle.
15909819|NCT03574402|Drug|AZD3759|200mg PO BID on days 1-28. 28 days as one cycle.
15909820|NCT03574402|Drug|Pirotinib|60mg PO QD/40mg PO BID on days 1-28. 28 days as one cycle.
15909821|NCT03574402|Drug|Nimotuzumab|400mg, iv gtt. on day 1,8,15. 21 days as one cycle.
15909822|NCT03574402|Drug|Pemetrexed|500mg/m^2, iv gtt. Q3W. 21 days as one cycle.
15909823|NCT03574402|Drug|Cisplatin|75mg/m^2, iv gtt. Q3W on day1. 21 days as one cycle.
15909824|NCT03574402|Drug|Sintilimab|200mg iv gtt. Q3W on day1. 21 days as one cycle.
15909825|NCT03574402|Drug|Gemcitabine|1g/m^2 iv gtt. on day1,8. 21 days as one cycle.
15909826|NCT03574402|Drug|Gemcitabine|1.25g/m^2 iv gtt. on day1,8. 21 days as one cycle.
15909827|NCT03574402|Drug|Carboplatin|AUC5 iv gtt. Q3W on day1. 21 days as one cycle.
15909828|NCT03574389|Biological|13vPnC|suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
15909890|NCT03573934|Other|GIP|GIP
15909830|NCT03574376|Drug|Bupivacaine Liposome Injection|Under ultrasound guidance, corresponding ribs will be identified. 3-5 ml of a 1.3% (13.3 mg/mL) of liposomal bupivacaine will be drawn into a syringe with a 1.5-in, 22-gauge needle. The needle will then be advanced 20° cephalad to the skin 3-4 cm lateral to midline at the level of each fractured rib, and 1-2 ribs levels above and below injury. The needle will be advanced 3 mm below the inferior margin of the rib, placing the tip in the space containing the neurovascular bundle. Following negative aspiration for blood or air, 3-5 mL of local anesthetic will be infused and the needle withdrawn. No more than 266 mg, or 20 ml, of the 1.3% (13.3 mg/mL) liposomal bupivacaine solution will be injected
15909831|NCT03574376|Drug|Bupivacaine|The anesthesia department will manage CEA. If possible, the patient will be in the sitting position. The skin will be prepped with chlorhexidine and sterilely draped. 3 mL of lidocaine 1% will be infiltrated the closest interspace to the rib fractures between T4 -T12. A Touhy needle will be inserted, the epidural space identified by loss of resistance technique. An epidural catheter will then be inserted to a depth of 12cm. 3 mL of test solution with lidocaine 1.5% with epinephrine, 1:200,000 will be injected with continuous EKG and SpO2 monitoring. Delivery of a 0.125% bupivacaine solution be continuously infused and titrated based on the patient's clinical status
15909832|NCT03574363|Drug|KBP-5074 0.25 mg tablet|Oral administration, QD, 84 days
15909833|NCT03574363|Drug|KBP-5074 0.5 mg tablet|Oral administration, QD, 84 days
15909834|NCT03574350|Behavioral|KS in Kangaroo Position|KSKP was applied daily at regular interval corresponding to the presence of parents. Our protocol is based on the Tiffany Field's protocol with some adjustments corresponding to the constraints of the hospital : the KS was applied 3 times a day and during 15 consecutive days in the hospital or at home and parents were responsible of delivering the intervention. Sunflower oil was used. During the first 5 days, parents performed KSKP with the support of the psychologist. After day 5, parents were expected to perform KSKP by themselves but could ask for help at any moment while in hospital or in the ambulatory follow-up. The KS always began approximately 60 minutes after the feed.
15909835|NCT03574350|Behavioral|KS in incubator|The infant is in the incubator, unclothed with diaper. Parents delivered KSI with the infant in supine position, stroking with the flats of the fingers with moderate pressure. Five 1-minute intervals, consisting of six 10-s periods of stroking, were applied to the following body regions: head, back, both legs and arms. The same process was repeated in prone position. The last part of the intervention was composed of 6 flexions of each extremity.
15909836|NCT03574337|Drug|Sugammadex|No additional information
15909837|NCT03574337|Drug|neostigmine/glycopyrolate|No additional information
15909838|NCT03574324|Drug|TPF+CCRT|Patients receive Neoadjuvant Docetaxel (75mg/m2 on day1 03:30-04:30) and cisplatin (75mg/m2 on day 1-5 10:00-22:00) and 5-FU(750mg/m2 on day 1-5 22:00-10:00) every 21days for three cycles followed by concurrent cisplatin (100mg/m2 on day1 10:00-22:00)every 21 days for three cycles during radiotherapy
15909839|NCT03574324|Drug|CCRT+PF|Patients receive concurrent cisplatin (100mg/m2 on day1 10:00-22:00)every 21 days for three cycles during radiotherapy followed by adjuvant cisplatin (80mg/m2 on day 1-5 10:00-22:00) and 5-FU(800mg/m2 on day 1-5 22:00-10:00) every 21days for three cycles
15909840|NCT03574311|Drug|Ferric carboxymaltose|A single dose of drug or placebo is administered preoperatively to participants
15909841|NCT03574311|Other|Physiological saline|Single infusion 100 ml physiological saline infusion preoperatively
15909842|NCT03574285|Drug|Anpl-one SR Tab. 300mg|Anpl-one SR Tab. 300mg tablets followed by Sarpodipil SR Tab. 300mg tablets
15909843|NCT03574285|Drug|Sarpodipil SR Tab. 300mg|Sarpodipil SR Tab. 300mg tablets followed by Anpl-one SR Tab. 300mg tablets
15909844|NCT03574272|Other|Patient Transfer Monitoring System|The subjects will be provided with portable oximeter and smart-phone which application for monitoring is installed, and the transmitted data will be monitored in real time via monitoring equipment in the (Patient-hospitalized) ward.
15909845|NCT03574246|Drug|chlorhexidine gluconate %0,12 benzydamine hydrochloride %0,15|chlorhexidine gluconate + benzydamine hydrochloride oral rinse
15909846|NCT03574246|Other|%0.9 NaCl Solution|isotonic sodium chloride
15909847|NCT03574220|Drug|Pembrolizumab|200mg IV every 21 days over 6 months
15909848|NCT03574220|Radiation|Stereotactic body radiotherapy|50 Grays (Gy) in 5 fractions over 5-14 days, or 60 Gy in 3 fractions over 8-14 days
15909849|NCT03574207|Device|Transcranial magnetic stimulation|Transcranial magnetic stimulation non-invasively applies very small amounts of electrical current to brain tissue; sham stimulation uses the same approach but applies little or no actual stimulation to the brain by using less power or greater distance between the head and the stimulator.
15909850|NCT03574194|Dietary Supplement|Methionine-restricted diet|The methionine-restricted diet diet (MRD) will begin 2 weeks prior to radiation therapy to deplete methionine stores in the body, continue during radiation, and extend for approximately 2 weeks after the last radiation fraction for a total of 6-10 weeks (depending on duration of radiation course).
15909851|NCT03574181|Other|Smartwatch to measure Blood Alcohol Level (BAL)|Subjects will wear a wristwatch with a sensor that measures blood alcohol level during a 1-hour period of consuming alcohol followed by a 5 hour observation period.
15909852|NCT03574168|Biological|CD19-CAR-T Cells|T cells purified from the PBMC of subjects or subjects' relatives which depends on their conditions, transduced with 4-1BB/CD3-ζ lentiviral vector, expanded in vitro for future administration.
15909853|NCT03574155|Behavioral|Pre-operative Counseling and Education|"Group control Pre-operative Orientation Routine Application of the questionnaire (ESAS) and (HADS) Post-operative Immediate (1 OP) Application of the Questionnaire to assess HADS and ESAS Anxiety (Patient)
~Experimental Group Pre-operative Counseling and Education Application of the questionnaire (ESAS) and (HADS)
~Late postoperative (2 - 4 weeks) Questioning the patient and companion evaluating the degree of satisfaction regarding the preoperative guidelines."
15909854|NCT03574142|Drug|Epanova|A single dose of Epanova 4 g will be administered as 4 capsules (each containing 1 g of Epanova) followed by a 72-hour washout period in Chinese healthy subjects. Subsequently, multiple doses of Epanova 4 g will be administered once daily for 14 consecutive days.
15909855|NCT03574129|Behavioral|Adolescent Transition Package|Clinic level intervention composed of an adolescent transition package with tools to support health care workers to disclose HIV status to adolescents and to track transition to adult care.
15909884|NCT03573973|Other|Sham comparator|The control condition is the existing store layout with a limited range of fresh fruit and vegetables that are placed at the back of the store.
15909857|NCT03574103|Behavioral|Caloric restriction plus TRF morning|Participants in this group will receive a eating plan with caloric restriction (513 to 770 kcal from estimated energy requirements) and 8 hours for eating (from 12 p.m. to 8 p.m.) and 16 hours of fasting, for 8 weeks.
15909858|NCT03574103|Behavioral|Caloric restriction plus TRF night|Participants in this group will receive a eating plan with caloric restriction (513 to 770 kcal from estimated energy requirements) and 8 hours for eating (from 8 a.m. to 4 p.m.) and 16 hours of fasting, for 8 weeks.
15909859|NCT03574090|Drug|Amoxicillin Clavulanate|To demonstrate its efficacy in the prophylaxis of infection to surgical wound will be used in dirty/contaminated emergency surgery and its efficacy will be compared with topical administration of physiological serum alone.
15909860|NCT03574090|Drug|Physiological Saline|To demonstrate its efficacy in the prophylaxis of infection to surgical wound will be used in dirty/contaminated emergency surgery and its efficacy will be compared with topical administration of physiological serum alone.
15909861|NCT03574077|Behavioral|Instant Messaging (IM)|Tailored automatic, fix- scheduled regular messages will be sent and counselors will interact with smokers in the intervention group through WhatsApp since initial contact and until 2-month after baseline. The interaction will follow the principle of Motivational Interviewing, which will focus on enabling change through the enhancement of intrinsic motivation and the exploration and resolution of ambivalence. Counsellors will identify discrepancies between participants' thought and their action, support their autonomy, be empathetic towards the participant, avoid confrontation, and adjust to resistance. Any smokers who do not use IM or refuse to receive IM messages will be contacted via SMS messages or telephone calls. For smokers who do not respond to regular messages, 3 additional prompt messages will be sent in the 1st month to initiate a conversation.
15909862|NCT03574077|Behavioral|AWARD advice|AWARD will be delivered to smokers onsite and this includes: Ask about smoking history, Warn about the high risk, Advise to quit or reduce smoking as soon as possible, Refer smokers to smoking cessation services (with a SC service information card), and Do it again: to repeat the intervention; participants who fail to quit or relapse will be encouraged to quit again (and those who have quit smoking will be encouraged to prevent relapse) during telephone follow-ups. The whole process of AWARD can be delivered within 1 to 2 minutes.
15909863|NCT03574077|Behavioral|NRT sampling|One-week free nicotine replacement therapy (NRT) sampling (gum or patch) will be disseminated to participants who are interested to try after completing the baseline questionnaire. An NRT use card containing reminders of NRT use and potential side effects will be given. Counselors and research staff will also check the side effects of NRT use during WhatsApp interaction and telephone follow-ups.
15909864|NCT03574077|Behavioral|Active referral|SC ambassadors will introduce various SC services in Hong Kong (using the SC service information card) and motivate smokers to use the SC services. Written consents will be obtained from smokers who are ready to book the service onsite for transfer of their contact telephone numbers to their chosen service providers. Our research staff will transfer the information to the service providers within a week since the enrollment. For smokers in Group A, our research staff will also assist them to re-book the appointments upon their request at follow-up. SC ambassadors will encourage smokers in Group A who are not ready to book SC service to make an early appointment and assist them at follow-up.
15909865|NCT03574077|Behavioral|SMS messaging|All smokers will receive fix-schedule general messages on SC through short message service (SMS) since their initial participation until 2-month after baseline. These messages include: (a) brief health warning, (b) benefit of quitting, (c) methods to quit and to cope with craving, and (d) SC services and their effectiveness. General SC messages will be sent twice per week in the 1st month and once per week in the 2nd month after joining this study.
15909866|NCT03574064|Other|Glucagon-Like Peptide-2 (GLP-2)|Glucagon-Like Peptide-2 (GLP-2) injection.
15909867|NCT03574064|Other|Glucose-dependent insulinotropic polypeptide (GIP)|Glucose-dependent insulinotropic polypeptide (GIP) injection.
15909868|NCT03574064|Other|GLP-2+GIP|GLP-2+GIP injection.
15909869|NCT03574064|Other|Placebo|Placebo injection.
15909870|NCT03574051|Drug|Probiotic|Evaluate probiotics for preventing adverse effects of hypothyroidism and improvement of side effects caused by 131I treatment
15909871|NCT03574038|Device|Transcranial Direct Current Stimulation|Patients will be randomized to active treatment (C-tDCS) vs sham stimulation in a 3:1 ratio. There will be 6 dose tiers, reflecting increasing intensity and duration of stimulation: Tier 1 - 1 mA, single 20 - min cycle; Tier 2- 2 mA, single 20 min cycle; Tier 3 - 1 mA, 2 cycles of 20 min/20 min off; Tier 4- 2 mA, 2 cycles of 20 min/20 min off; Tier 5 - 1 mA, 3 cycles of 20 min/20 min off; Tier 6 - 2 mA, 3 cycles of 20 min/20 min off.
15909872|NCT03574038|Other|Sham Stimulation|Patients will be randomized to active treatment (C-tDCS) vs sham stimulation in a 3:1 ratio. Patients in the sham stimulation arm at all the tiers will have the cap and electrodes in place, and sham switch moved but without prolonged delivery of electrical stimulation.
15909873|NCT03574025|Other|Questionnaire|To telephone the patient/family to look into how the patient is doing, moderate/severe brain damage.
15909874|NCT03574012|Device|Monitoring Device|Use Fitbit tracker
15909875|NCT03574012|Other|Informational Intervention|Receive individualized health and fitness information from clinician, supplemented with peer support through the study's social media platform
15909876|NCT03574012|Other|Informational Intervention|Receive general health and fitness information from clinician
15909877|NCT03574012|Other|Questionnaire Administration|Ancillary studies
15909878|NCT03573999|Drug|Mannitol|4.6 ml/kg will be administered before dura opening
15909879|NCT03573999|Drug|NaCl 7.5%|2 ml/kg will be administered before dura opening
15909880|NCT03573986|Biological|[18F]fluoromisonidazole|positron emitting radiopharmaceutical that has been studied in vivo in humans for measurement of regional hypoxia in a number of tumor types with positron emission tomography (PET/CT)
15909881|NCT03573986|Drug|Bevacizumab|Bevacizumab (Avastin, Genentech/Roche) is a humanized monoclonal antibody that binds to VEGF preventing its interaction with VEGFRs resulting in suppression of VEGF signaling.
15909882|NCT03573986|Radiation|positron emission tomography (PET/CT).|PET-CT Scan 1.) before start of Bevacizumab up to approximately 4 weeks and 2.) within 12-22 days of start of Bevacizumab
15909883|NCT03573973|Other|Improved product placement of fresh fruit and vegetables|The intervention includes the creation of a new fresh fruit and vegetable section at the store entrance with expanded range thus improving the placement (availability and position) of fresh fruit and vegetables.
15909893|NCT03573921|Drug|Gastrograﬁn|Patients will receive a single dose of Gastrografin via the nasogastric tube at 24 hours after hospital admission. After receiving Gastrografin, patients will receive the same standard non-surgical management that patients outside of the trial receive.
15909894|NCT03573921|Other|Saline solution (control treatment)|Patients will receive a single dose of saline solution via the nasogastric tube at 24 hours after hospital admission. After receiving saline solution, patients will receive the same standard non-surgical management that patients outside of the trial receive.
15909895|NCT03573908|Drug|Linaclotide|Oral capsule
15909896|NCT03573908|Drug|Placebo|Matching placebo oral capsule
15909897|NCT03573895|Other|Foam-Roller|Application of foam roller in the posterior part of thigh.
15909898|NCT03573895|Other|Neuromuscular stretching|Use of a neuromuscular stretching applied to the hamstring muscles
15909899|NCT03573895|Other|Pasive stretching|Use of a pasive stretching applied to the hamstring muscles
15909900|NCT03573882|Drug|Voxelotor|300mg or 500mg Tablet, Oral, With or Without Food
15909901|NCT03573869|Procedure|Cryoballoon ablation|Left atrial ablation using cryoballoon to achieve pulmonary vein isolation
15909904|NCT03573843|Other|Prevention software|All patients will have a tablet with the software PREVEDEL between 09:00-19:00 hrs.
15909905|NCT03573843|Other|Placebo|All patients will have a tablet without the software PREVEDEL between 09:00-19:00 hrs.
15909906|NCT03573830|Behavioral|Transport Canada material|The current Transport Canada booster seat education material focuses on imparting guidelines; that is, it describes, in plain language, the minimum and maximum ages, heights, and weights to determine when a child should use a booster seat, and when it is safe for a child to use only the seat belt. This material does not describe the principle of operation of seat belts (i.e., redirecting crash forces to the rib cage and pelvis), nor the principle of operation of booster seats (i.e., ensuring the seat belt is placed correctly across the chest and hips).
15909907|NCT03573830|Behavioral|Enhanced material|Enhancements to the booster seat education material were developed based on the hypothesis that parents would better appreciate the additional injury risk reduction afforded by booster seats, if they understand that: (1) seat belts prevent injuries by redirecting crash forces to stronger parts of the body (i.e., rib cage and pelvis); and (2), without booster seats, children would wear the seat belt on their abdomen and neck, which directs crash forces to more vulnerable anatomical structures (i.e., internal organs and spine).
15909908|NCT03573817|Drug|Revefenacin|Revefenacin is administered via a nebulizer.
15909909|NCT03573817|Drug|Placebo|Placebo version of Revefenacin is administered via a nebulizer.
15909910|NCT03573817|Drug|Formoterol|Administered sequentially in both revefenacin and placebo arms using a nebulizer.
15909911|NCT03573804|Other|Prone to Supine MRI|The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.
15909912|NCT03573778|Behavioral|iHEAL|Women work with a Registered Nurse in 10-18 visits (over 6 months) that focus on 6 inter-related 6 components (areas): Safeguarding, Managing Symptoms, Getting Basics, Cautiously Connecting, Regenerating Family, Renewing Self. Using a standard 3 phase process, and guided by 5 principles, the nurse discusses each of these components with the woman in order to identify the woman's needs, experiences and priorities. The nurse then provides personalized support to assist the woman in address the concerns that she sees as most important for her health and well-being; this support includes linking women to existing services if she chooses.
15909913|NCT03573778|Behavioral|Information about Community Services|Women are provided with information about community services appropriate for women experiencing intimate partner violence and consistent with what service providers might recommend (usual care). Women are encouraged to use this information as they see fit.
15909914|NCT03573765|Procedure|Shoulder arthroplasty|Any form of joint replacement of the glenohumeral joint including prosthetic and excision.
15909915|NCT03573765|Procedure|Elbow arthroplasty|Any form of joint replacement of the elbow joint including prosthetic and excision.
15909916|NCT03573765|Procedure|Hand and wrist arthroplasty|Any form of joint replacement of joints of the hand and wrist including prosthetic and excision.
15909917|NCT03573765|Procedure|Nerve decompression|Open or endoscopic release of peripheral nerve entrapment - subdivided by anatomical site of compression. Specific subgroups will include carpal tunnel and cubital tunnel release.
15909918|NCT03573765|Procedure|Tendon repair|Open or arthroscopic repair or reconstruction of tendons of the shoulder, hand and upper limb in general.
15909919|NCT03573765|Procedure|Joint stabilisation|Any procedure designed to increase stability of a joint, including soft tissue and bony blocking procedures.
15909920|NCT03573765|Procedure|Excision/division/release of palmar fascia|Any procedure performed for treatment of Dupuytren's contracture.
15909921|NCT03573765|Procedure|Surgical fixation of fractures|Any internal or external fixation of upper limb fractures - analysed by anatomical site.
15909922|NCT03573765|Procedure|Soft tissue release/debridement/excision|Any removal or release of soft tissue for treatment of stiffness, functional impairment or pain. Specific subgroups will include trigger finger release, subacromial surgery and surgery for frozen shoulder.
15909923|NCT03573765|Procedure|Intra-articular injection|Any intra-articular injection
15909924|NCT03573752|Other|outpatient management for promontofixation by laparoscopy|postoperative H8 exit after laparoscopic promontofixation
15909925|NCT03573752|Other|questionnaire|Each patient will complete a questionnaire on the experience of management, both in terms of pain management, anxiety and overall satisfaction.
15910010|NCT03573050|Drug|RIV-TDS 13.3 mg/24 h|5 consecutive transdermal patch applications, each with a nominal release rate of 13.3 mg/24 hours
15939170|NCT03347968|Drug|Esmolol|All participants will receive Esmolol
15909926|NCT03573739|Procedure|low-calorie low-protein|In the low-calorie low-protein (Low) group, the calorie target will be 6 kcal/kg/day and the protein target 0.2-0.4 g/kg/d during the acute phase, i.e. from D0 to D7. On D8, the calorie target will be 30 kcal/kg/d and the protein target 1.2-2.0 g/kg/d.
15909927|NCT03573739|Procedure|standard-calorie/standard-protein|In the standard-calorie/standard-protein (Standard) group, the first-line calorie target calculated based on body weight is 25 kcal/kg/day and the protein target 1.0-1.3 g/kg/d during the acute phase, i.e. from D0 to D7. On D8, the calorie target will be 30 kcal/kg/d and the protein target 1.2-2.0 g/kg/d.
15909928|NCT03573726|Other|Closed diurnal indwelling catheter (CDIC)|Each participant underwent an evaluation during standard of care CIC use vs evaluations during use of the study intervention (CDIC).
15909929|NCT03573713|Other|Care Groups|The Care Groups model has strong evidence of improvement of maternal and child health and maternal hygiene/nutrition behaviors.Through Care Groups, women will learn about proper water, sanitation, and hygiene behaviors; Infant and Young Child Feeding practices; management of childhood illnesses; home management, referral and care seeking for sick children; family planning; and use of preventive services available at health facilities (e.g., growth monitoring, deworming, vitamin A supplementation). All children under five years of age will also be screened for acute malnutrition by the Care Group Volunteers, and receive deworming medication and vitamin A supplementation twice a year through the Ministry of Health and Community Health Workers as part of national campaigns.
15909930|NCT03573713|Behavioral|IPT-G|"IPT-G is an effective, low-cost, short-duration community-based method for decreasing depression has been established that was first rigorously tested in Uganda. Several Private Voluntary Organizations in Africa have used this low-cost, short-duration, community-based group psychosocial approach and found it to be a culturally-sensitive, acceptable, and feasible approach to address depression.
~IPT-G treatment spans 12 weeks of treatment, consisting of 3 phases (early, middle, and termination). Within this treatment, participants are also assessed for symptoms of depression every week."
15909931|NCT03573700|Drug|Cyclophosphamide|Given IV
15909932|NCT03573700|Drug|Fludarabine|Given IV
15909933|NCT03573700|Drug|Mesna|Given IV
15909934|NCT03573700|Device|CliniMACS|The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest.
15909935|NCT03573700|Biological|CD19- specific CAR engineered autologous T-cells (SJCAR19 product)|Given IV
15909936|NCT03573687|Dietary Supplement|Micellar Casein Protein|The micellar casein protein supplement (PRO, total protein content: 30 g, 120 kcals; 30 g micellar protein) and non-caloric sensory-matched placebo (PLA, 0kcals) will be specifically formulated by Dymatize® Nutrition FrieslandCampina® and consumed in a randomized order. Participants will consume the daytime supplement 30 minutes after RT and the nighttime supplement about 30 minutes before bedtime. The supplements will be premixed, taste-matched (chocolate), and provided in opaque shaker bottles.
15909937|NCT03573687|Other|Resistance Exercise Training|Resistance exercise training (RT) will target the full body and exercises will be performed using a barbell. Exercises will be performed in the following order: back squat, bench press, Romanian deadlift, bent-over row, shoulder press, and reverse lunges)
15909938|NCT03573674|Behavioral|CE - Cognitive Ergonomics (KERGO)|"CE Cognitive ergonomics Intervention deals with themes such as disruptions, interruptions, information overload.
~A cognitive behaviour change method was applied in the intervention tasks. Both the tasks of discussing and developing new practices within the groups of individuals and the tasks for individuals were constructed to utilize mental contrasting with implementation intentions (MCII) method"
15909939|NCT03573674|Behavioral|RS - Recovery Support (KUORMA)|"RS Recovery Support / Stress Management Intervention deals with themes such as workload management, recovery, work-family balance.
~A cognitive behaviour change method was applied in the intervention tasks. Both the tasks of discussing and developing new practices within the groups of individuals and the tasks for individuals were constructed to utilize mental contrasting with implementation intentions (MCII) method"
15909940|NCT03573661|Device|Breast Cancer Locator (BCL)|This locator will be constructed pre-operatively, sterilized and provided to the surgeon at the time of procedure. The outline of the breast cancer on the breast surface at the point where the cancer is closest to the skin is built into the locator, so that the surgeon can simply apply the locator to the patient's breast and trace the tumor outline on the skin.
15909941|NCT03573648|Drug|Avelumab|Avelumab (10 mg/kg) will be given intravenously on cycles 2 - 4, every 2 weeks.
15909942|NCT03573648|Drug|Endocrine therapy|"The endocrine therapy given will depend on menopausal status.
~Premenopausal women will receive tamoxifen AND either Goserelin or Leuprolide:
~Tamoxifen (20mg) will be given orally daily x 4 cycles. (Other Names: Nolvadex)
~Goserelin (3.6mg) will be given subcutaneously (under the skin) on Day 1 of each cycle x 4 cycles. (Other Names: Zoladex)
~Leuprolide (3.75mg) will be given intramuscularly (in the buttock, thigh, or upper arm) on Day 1 of each cycle x 4 cycles. (Other Names: Leuprorelin, Lupron, Eligard)
~Postmenopausal women will receive letrozole:
~- Letrozole (2.5mg) will be given orally daily each cycle x 4 cycles. (Other Names: Femara)"
15909943|NCT03573648|Drug|Palbociclib|Palbociclib (125 mg) will be given orally on days 1-21 of each cycle x 4 cycles.
15909944|NCT03573635|Device|Supratube|Aspiration of orotracheal secretions with supratube device
15909945|NCT03573635|Other|Reference|Usual aspiration with any other device
15909946|NCT03573622|Drug|Anpl-one SR Tab. 300mg|Anpl-one SR Tab. 300mg tablets followed by Sarpodipil SR Tab. 300mg tablets
15909947|NCT03573622|Drug|Sarpodipil SR Tab. 300mg|Sarpodipil SR Tab. 300mg tablets followed by Anpl-one SR Tab. 300mg tablets
15909948|NCT03573609|Device|Supranav|Continuous supraglottic suction device for patients with orotraqueal intubation an mechanical ventilation
15909949|NCT03573596|Drug|Dasatinib|CML patients who have failed a first stopping attempt and have used any TKI for one year will switch to dasatinib 100 mg qd for an additional 2 years before second stop attempt.
15910011|NCT03573050|Drug|Exelon® 13.3 mg/24 hours transdermal patch|5 consecutive transdermal patch applications, each with a nominal release rate of 13.3 mg/24 hours
15910012|NCT03573037|Drug|Oral anticoagulant|1:1 randomization to 1-month anticoagulation or 2-month anticoagulation after radiofrequency catheter ablation of paroxismal atrial fibrillation
15940035|NCT03341312|Biological|Insulin Lispro|Administered SC
15909950|NCT03573583|Behavioral|Resistance Training|The intensity, volume, tempo, and progression will be based on the Federal Physical Activity guidelines. The resistance training exercises will include mainly multi-joint exercises using selectorized machines. Each session will include upper body exercises (Chest Press, Shoulder Press, Seated Rows, Bicep curls, and Tricep Extensions) and lower body exercises (Leg Press, Leg Extension and Leg Curls, and Calf raise) that will be tailored to the participant needs.
15909951|NCT03573583|Behavioral|Successful Aging|The successful aging will attend stretching and health lectures as a group . The topics might include, medication management, disease management (e.g. blood pressure, diabetes, arthritis, dementia, pain management, diet) and other health related matters.
15909952|NCT03573570|Other|Fortified rice kernels|The proposed project will leverage the existing state-run public distribution system (PDS) to provide fortified rice through Fair Price Shops (FPS) using a domestically manufactured rice grain (Fortified Rice Kernels: FRK). FRKs are grains made from rice flour, enriched with iron, zinc, Vitamin A, Vitamins B1, B3, B6, B9 and B12, and shaped like a conventional grain of rice. It is mixed into conventional rice in specified ratio of 1:100. The proposed study will be conducted as a cluster-randomized controlled trial, with baseline and follow-up surveys conducted 12-15 months apart. In the interim, 110 Treatment FPS, and all households receiving rice from them, will be randomly assigned to receive fortified rice, and another 110 randomly assigned Control FPS, and the households receiving rice from them, will continue receiving conventional rice and represents the status quo. This study will be conducted in one sub-district of Tamil Nadu with a population of about 1/2 million people.
15909953|NCT03573557|Device|Pink Pad|Pink Pad made by Xodus Medical Inc. used for patients in steep Trendelenburg position during surgery.
15909954|NCT03573557|Device|Bean Bag|Vac-Pac Bean Bag made by Olympic used for patients in steep Trendelenburg position during surgery.
15909955|NCT03573557|Device|Gel Pad|Gel Pad used for patients in steep Trendelenburg position during surgery.
15909956|NCT03573544|Drug|OBI-888|For the dose-escalation phase, OBI-888 will be given weekly at the dose levels of 5, 10, and 20 mg/kg.
15909957|NCT03573544|Drug|OBI-888|For the dose-expansion phase, OBI-888 will be given weekly at 20 mg/kg dose level.
15909958|NCT03573544|Device|Globo H IHC Assay|This assay will be used to identify eligible patients who may clinically benefit from the OBI-888 treatment, defined by Globo H expression.
15909959|NCT03573531|Other|Laboratory analysis|Analysis of lipid peroxidation markers (malondialdehyde, 4 hydroxy-2-nonenal, hexanal, and 8-iso-PGF2α) Analysis of fatty acid content Analysis of total antioxidant capacity
15909960|NCT03573518|Drug|BTX 1503|BTX 1503 Dose 1 liquid formulation, or BTX 1503 Dose 2 liquid formulation
15909961|NCT03573518|Drug|Vehicle|Placebo
15909962|NCT03573505|Drug|BG00011|Administered as specified in the treatment arm.
15909963|NCT03573505|Drug|Placebo|Administered as specified in the treatment arm.
15909964|NCT03573492|Other|Education|Type of teaching being assigned to student arms
15909965|NCT03573479|Other|PICU Liber8 Bundle|Bundle of elements for quality improvement
15909966|NCT03573466|Procedure|Muscle biopsy|A motor point biopsy of deltoid muscle will be carried out at the time of inclusion using a standardized procedure, as routinely performed. Muscle samples will be removed from the deltoid muscle by open biopsy under local anaesthesia. The region containing NMJs will be determined by the small twitch provoked by the tip of the scalpel on the surface of the muscle fascicles.
15909967|NCT03573453|Other|enteral nutrition|administration of enteral nutrition
15909968|NCT03573440|Other|mindful education on eating|Mindful eating education material: mindful eating handout by move.va.gov. It includes topics such as: observe your body, do not judge yourself, notice your reaction to food and savor your food.
15909969|NCT03573427|Device|Trans-atrial septal placement LV lead for CRT|
15909971|NCT03573401|Combination Product|Photodynamic therapy (PDT) (ALA-PDT, Ameluz®-PDT)|The Main Target Lesion will be marked by at least 3 ink marks prior to PDT to enable precise excision for histopathological assessment 12 weeks after the first or second PDT cycle dependent on the clearance status of the lesion. All target lesions should be prepared prior to drug application by degreasing, removal of all scabs and crusts, and roughening of the surface, if appropriate. Bleeding should be avoided. The formulations will then be applied to the lesions (maximal combined lesion area incl. margin is 20 cm²) located in 1 to 2 illumination areas. The medication should be applied to the entire lesion(s) plus a 0.5 - 1.0 cm margin surrounding each lesion at a thickness of 1 mm, allowed to dry (for approximately 10 minutes), covered with occlusive dressing, and incubated for approximately 3 h. Thereafter, any remnants of the IMP will be removed carefully and the PDT illumination will be administered using the light emitting diode (LED) red light device BF-RhodoLED®.
15909972|NCT03573401|Combination Product|Placebo Photodynamic therapy (PDT) (vehicle to BF-200 ALA containing no active ingredient)|The Main Target Lesion will be marked by at least 3 ink marks prior to PDT to enable precise excision for histopathological assessment 12 weeks after the first or second PDT cycle dependent on the clearance status of the lesion. All target lesions should be prepared prior to drug application by degreasing, removal of all scabs and crusts, and roughening of the surface, if appropriate. Bleeding should be avoided. The formulations will then be applied to the lesions (maximal combined lesion area incl. margin is 20 cm²) located in 1 to 2 illumination areas. The medication should be applied to the entire lesion(s) plus a 0.5 - 1.0 cm margin surrounding each lesion at a thickness of 1 mm, allowed to dry (for approximately 10 minutes), covered with occlusive dressing, and incubated for approximately 3 h. Thereafter, any remnants of the IMP will be removed carefully and the PDT illumination will be administered using the light emitting diode (LED) red light device BF-RhodoLED®.
15909973|NCT03573388|Device|Optical coherence tomography (OCT)|Lesion OCT assessment
15909974|NCT03573375|Behavioral|Questionnaires|Participants complete a series of questionnaires about exercise, symptoms, and physical abilities. These should take about 5 minutes to complete.
15909975|NCT03573362|Device|ViziShot FLEX 19G needle|EBUS-TBNA using the ViziShot FLEX 19G needle
15909976|NCT03573362|Device|Vizishot 22G needle (standard)|EBUS-TBNA using the Vizishot 22G needle (standard)
15910013|NCT03573024|Drug|Azacitidine|On day 1 of cycle 1, azacitidine 75 mg/m2 SC or IV will be given, and will continue for 7 days.
15909977|NCT03573349|Drug|Ketamine|We will enroll 20 adults with treatment-resistant unipolar major depression and will provide one i.v. ketamine infusions (0.5 mg/kg, infused over 40 minutes) and measure their depressive symptom responses. Adults (aged 18-65 years) with treatment-resistant depression will be included. Biomarkers will be developed using blood samples from study subjects, taken prior to (predictive biomarkers), and following ketamine treatment (change biomarkers). This will be an open-label feasibility trial.
15909978|NCT03573336|Drug|Vilaprisan (BAY1002670)|Intake orally, once daily
15909979|NCT03573336|Drug|Matching Placebo|Intake orally, once daily
15909980|NCT03573323|Drug|Ixekizumab|Administered SC
15909981|NCT03573323|Drug|Guselkumab|Administered SC
15909982|NCT03573323|Drug|Placebo|Administered SC
15909983|NCT03573310|Drug|JNJ-64619178|JNJ-64619178 capsules to be administered orally.
15909984|NCT03573297|Drug|Cariprazine|Cariprazine capsules, oral administration, once daily
15909985|NCT03573297|Drug|Placebo|Matching placebo capsules, oral administration, once daily
15909986|NCT03573284|Diagnostic Test|fractional exhaled nitric oxide(FeNO)|FeNO level was evaluated according to the American Thoracic Society (ATS)/ERS recommendations using a NIOX MINO analyzer (Aerocrine, Solna, Sweden) .Subjects were informed to deeply inhale NO-free air and immediately exhale in full via a mouthpiece at a constant flow rate (50 ml/s) for 10s.
15909987|NCT03573284|Diagnostic Test|impulse oscillometry(IOS)|The patient take seats, body relax, make sure the mouthpiece is fully covered by mouth, then clip nose with both hands to cover both sides of the cheek, and then calm breathing 1 minutes, the computer is automatically collected data calculation and print out the measurement results.
15909988|NCT03573271|Device|MCD|Micro-coring skin removal with automated coring device
15909989|NCT03573258|Dietary Supplement|Fiber or Placebo (depending on the randomization)|ingestion of dietary fibers prior to meal intake
15909990|NCT03573245|Drug|Tranexamic Acid|Tranexamic acid effect on perioperative bleeding in orthopedic surgery
15909991|NCT03573219|Radiation|Short-wave diathermy|The application of SWD will be carried out by a CEC M-8 short-wave thermotherapy unit. The device has capacitive applicators, that will be situated around the muscle to be irradiated on top of a cotton towel, in order to absorb perspiration and avoid undesired heating effects. Afterwards the emission mode (continuous or pulsed) will be selected, and application of SWD will start. The intensity of SWD will be gradually increased until the volunteer perceives a warm sensation, and once familiarized with this perception, the intensity will be increased until a sensation of constant but tolerable pain is evoked. This sensation will be maintained throughout the duration of the SWD application, estimated in approximately 10 minutes.
15909992|NCT03573206|Device|Cardiva Mid-Bore Venous Vascular Closure Device (VVCS)|The device will be used to close all femoral venous access sites at the end of the case.
15909993|NCT03573193|Other|ridge preservation|"Intra operative procedures (for both groups) ridge preservation
~Local anesthesia will be given to the patient.
~Scrubbing and draping of the patient will be carried out in a standard fashion for intra oral procedures.
~A crestal incision was made, and a mucoperiosteal flap was elevated. Implant osteotomies were prepared according to the recommendations and desired dimensions of implants.
~In study group: tooth extraction with ridge preservation using deproteinized bovine bone mineral Bio-Oss
~In the comparators group: tooth extraction with ridge preservation using an alloplastic ceramic material beta tricalcium phosphate (TCP)."
15909994|NCT03573167|Behavioral|In-Person Motivational Interviewing (MI)|This is a counseling intervention to support behavior change conducted in-person (face-to-face) between the investigator and the participant.
15909995|NCT03573167|Behavioral|Mobile Motivational Interviewing (MI)|This is a counseling intervention to support behavior change conducted entirely over the mobile phone between the investigator and the participant
15909996|NCT03573154|Other|administration of the liquid 1 and then the liquid 2|The patient will received the e-liquid 1 in the first visit and the e-liquid 2 in the second
15909997|NCT03573154|Other|administration of the liquid 2 and then the liquid 1|The patient will received the e-liquid 2 in the first visit and the e-liquid 1 in the second
15909998|NCT03573141|Other|Physical Therapy|Subjects received a comprehensive physical therapy evaluation after baseline data collection and received a normal course pf physical therapy treatment based on impairments identified.
15909999|NCT03573128|Behavioral|Students with Autism Accessing General Education|With study team coach support, teacher implemented modules addressing student behavioral/academic goals.
15910000|NCT03573128|Other|Enhanced Services As Usual|Teaching staff access in-service presentations and print materials with no active study team coaching.
15910001|NCT03573115|Drug|Adapalene-Benzoyl Peroxide Gel 0.1-2.5%|Topical gold microparticles (SEB-250) are delivered to two facial areas at baseline, patients are then prescribed a topical Adapalene-Benzoyl Peroxide Gel 0.1-2.5% for 6 weeks followed by a new exposure to gold microparticles (SEB-250)
15910002|NCT03573102|Drug|SGLT2 inhibitor|SGLT2 inhibitor 10 mg/day
15910003|NCT03573102|Drug|ACE inhibitor|ACE inhibitor once daily
15910004|NCT03573089|Drug|Liberal phosphate target|All phosphate-lowering medications in use at baseline will be discontinued. Phosphate-lowering medications will be prescribed only if serum phosphate concentration exceeds 2.50 mmol/L. The choice and dosages of phosphate-lowering medications will be at the discretion of treating physicians and/or participants.
15910005|NCT03573089|Drug|Intensive phosphate target|This will be achieved by prescribing phosphate-lowering medications aimed to intensively lower serum phosphate concentration towards normal level (≤1.50 mmol/L). The choice and dosages of phosphate-lowering medications will be at the discretion of treating physicians and/or participants.
15910006|NCT03573076|Combination Product|Photodynamic therapy|Photodynamic therapy with Methyl Aminolevulinate creme and red light.
15910007|NCT03573076|Device|Non-ablative Thulium laser (NAFL)|Non-ablative Thulium laser (NAFL).
15910008|NCT03573076|Device|Radio-frequency microneedles (RF-MN)|Radio-frequency microneedles (RF-MN).
15910009|NCT03573063|Other|Androgen metabolism after starvation|"The 20 women will all undergo the same process of starvation for 48 hours. During this time three blood samples and three 24-hours urine samples will be collected. At baseline, the investigators will draw blood, perform a pregnancy test and collect the 24 hours urine as well as a spot urine.
~Then the 48 hours starvation starts and two blood and two 24 hours urine samples and spot urines will be collected after 24 and 48 hours in the morning. After the third visit the study is completed for the participant."
15910014|NCT03573024|Drug|Venetoclax|Starting on day 1 of cycle 1, venetoclax will be initiated. It will be dose escalated to a target dose of 600 mg in the following manner: 100 mg on day 1, 200 mg on day 2, 400 mg on day 3 and 600 mg on day 4. The patient then continues to take the 600mg dose for the remainder of the 28 day cycle. Each dose of venetoclax will be self-administered with approximately 240 mL of water within 30 minutes after the completion of a meal, preferably breakfast. The dose should be administered at the same time each day. On days the subject is given azacitidine, venetoclax must be given first.
15910015|NCT03573011|Diagnostic Test|[18F]PSMA-11|18F-PET imaging
15910016|NCT03572998|Drug|Indocyanine Green (ICG)|Injection of ICG as a fluorophore for Near Infrared fluorescence Imaging (NIRF)
15910017|NCT03572985|Other|Road-tracking test|Driving with simulator program for SDLP measurement
15910018|NCT03572985|Other|Car-following test|Driving with simulator program for DCV measurement
15910019|NCT03572985|Other|Harsh-braking test|Driving with simulator program for BRT measurement
15910020|NCT03572972|Drug|Apixaban|Treatment for NVAF patients
15910021|NCT03572972|Drug|Dabigatran|Treatment for NVAF patients
15910022|NCT03572972|Drug|Rivaroxaban|Treatment for NVAF patients
15910023|NCT03572972|Drug|warfarin|Treatment for NVAF patients
15910024|NCT03572972|Drug|Antiplatelets|Treatment for NVAF patients
15910025|NCT03572959|Drug|0.1 % topical triamcinolone acetonide|0.1 % topical triamcinolone acetonide preparation was used where the patients' were instructed to apply the gel 4 times daily, with no food or fluid taken one hour after application.
15910026|NCT03572959|Device|SIROIaser|"Oral Lichen Planus lesions were irradiated with a 970-nm diode laser with a 2 W irradiation power in a continuous non-contact mode. The laser beam was delivered using a fiber-optic tip with a 320 µm diameter with defocused mode directed at the lesions plus 0.5 cm peri- lesional tissues with a slight overlapping in order to evenly distribute energy covering all the lesional and peri-lesional tissues until blanching of the area was observed.14 Diode laser was calibrated to an output power of 3W, frequency of 30 Hz, energy of 180 joule and time interval of 8 minutes divided into 4 sessions , two min each with one minute rest in between to allow for tissue relaxation.
~Irradiation was done twice weekly (once every third day) for two months until the resolution of signs for a maximum of ten sessions."
15910027|NCT03572946|Procedure|Targeted prostate biopsy|MRI-guided targeted prostate biopsy
15910028|NCT03572946|Procedure|Standard biopsy|Transperineal ultrasound guided prostate biopsy(SB).
15910029|NCT03572933|Drug|ganaxolone|active drug
15910030|NCT03572933|Drug|Placebo|inactive
15910031|NCT03572920|Device|Objective sleep evaluation by actigraphy|Each subject will wear a wrist activity monitor (actigraphy) to detect his/her sleep behaviour during hospitalization.
15910032|NCT03572920|Other|Pittsburgh Sleep Quality Index (PSQI)|Each subject will fill twice the Pittsburgh Sleep Quality Index (PSQI), before hospitalization and after the 10th day, to evaluate his/her subjective sleep quality.
15910033|NCT03572907|Other|Rhinoplasty questionnaire|Each patient will complete a validated rhinoplasty questionnaire (Rhinoplasty Outcome Evaluation) before and after the intervention
15910034|NCT03572894|Device|PVI and RPVI measurements|"PVI and RPVI measurements during variations of the tidal volume (Vt challenge) and a recruitment maneuver in anesthetized and mechanically ventilated patients.
~T0 : Vt 6 mL/kg of predicted body weight (PBW) during 5 minutes
~T1 : Vt 8 mL/Kg of PBW during 5 minutes
~T2 : Vt 10 mL/kg of PBW during 5 minutes
~T3 : Vt 6 mL/kg of PBW during 5 minutes
~T4 : A single recruitment maneuver
~Data will be recorded at each step."
15910035|NCT03572881|Device|Endocardial mapping|An endocardial mapping of the pulmonary infundibulum will be performed during the electrophysiological exploration between asymptomatic patients with Brugada type 1 and patients with symptomatic Brugada type 1.
15910036|NCT03572868|Other|Evaluation of the long term neurodevelopmental outcome|Evaluation of the long-term neurodevelopmental outcome of newborns who have an isolated transverse cerebellar diameter < 5th centile during the second or the third trimester of pregnancy.
15910037|NCT03572855|Combination Product|Scoliosis Brace|Brace will be fitted to each subject by a spine orthopedic surgeon before the testing. The subject will wear the fitted brace for 2 months.
15910038|NCT03572842|Other|quantiferon monitor test|different blood test with quantiferon monitor
15910039|NCT03572829|Drug|Aprepitant|Intensity-modulated radiotherapy was given to the patients with regimen of 69.96 Gy-73.92 Gy to the gross target volume of nasopharynx,69.96 Gy to the gross target volume of positive nodes, 60.06 Gy the high risk clinical target volume, 50.96 Gy to the low risk clinical target volume. Concurrent chemotherapy is administrated with cisplatin 100mg/m2 at d1, d22, d43 during radiotherapy. Patients receive concurrent aprepitant 125mg, dexamethasone 12mg, and ondansetron 8mg p.o. on day1. AND then patients received aprepitant 80mg, dexamethasone 8mg on day 2-5 at every chemotherapy cycle.
15910040|NCT03572816|Device|Settner shoe|custom-made heel-unloading orthosis ('Settner shoe') in aftercare of calcaneus fractures (used according to manufacturer), certified 'CE' product with more than 10 years experience
15910041|NCT03572803|Other|Group of Dry Needling|Every group will receive a total of 3 treatment sessions distributed throughout 4 weeks of treatment. The program of eccentric exercises will be done by participants at home 5 days a week, two times a day.
15910042|NCT03572803|Other|Group of Electrolysis|Every group will receive a total of 3 treatment sessions distributed throughout 4 weeks of treatment. The program of eccentric exercises will be done by participants at home 5 days a week, two times a day.
15910043|NCT03572803|Other|Control Group|Every group will receive a total of 3 treatment sessions distributed throughout 4 weeks of treatment. The program of eccentric exercises will be done by participants at home 5 days a week, two times a day.
15910044|NCT03572790|Drug|Prucalopride|1mg prucalopride capsule, once daily for seven days
15910045|NCT03572790|Other|Placebo|Lactose placebo capsule, once daily for seven days
15910046|NCT03572777|Drug|Concomitant therapy|Amoxicillin ('Amoksicilin') 1 g bid 14 days.
15910047|NCT03572777|Drug|Concomitant therapy|Clarithromycin ('Makcin') 500 mg bid for 14 days
15910048|NCT03572777|Drug|Concomitant therapy|Metronidazole ('Medazol') 500 mg bid for 14 days
15910049|NCT03572777|Drug|Concomitant therapy|Esomeprazole ('Emanera') 40 mg bid for 14 days
15910050|NCT03572777|Drug|Hybrid therapy|Amoxicillin ('Amoksicilin') 1 g bid 14 days
15910051|NCT03572777|Drug|Hybrid therapy|Esomeprazole ('Emanera') 40 mg bid for 14 days
15910052|NCT03572777|Drug|Hybrid therapy|Clarithromycin ('Makcin') 500 mg bid for the last 7 days
15910053|NCT03572777|Drug|Hybrid therapy|Metronidazole ('Medazol') 500 mg bid for the last 7 days
15910054|NCT03572764|Drug|CPX-351|-CPX-351 will be provided by Jazz Pharmaceuticals
15910055|NCT03572764|Procedure|Research skin biopsy|"-And/or buccal swab
~Pre-treatment
~Post-induction (no earlier than Day 28 and no later than Day 56 from last induction)"
15910056|NCT03572764|Procedure|Research blood draw|"Pre-treatment
~Post-induction (no earlier than Day 28 and no later than Day 56 from last induction)
~Post-consolidation 1 (if applicable)
~Post-consolidation 2 (if applicable)
~Post-transplant Day 30 (if applicable)
~Post-transplant Day 100 (if applicable)"
15910057|NCT03572764|Procedure|Research bone marrow aspirate|"Pre-treatment
~Post-induction (no earlier than Day 28 and no later than Day 56 from last induction)
~Post-consolidation 1 (if applicable)
~Post-consolidation 2 (if applicable)
~Post-transplant Day 30 (if applicable)
~Post-transplant Day 100 (if applicable)"
15910058|NCT03572751|Diagnostic Test|Bed-, wrist- and ECG-sensor monitoring|Bed-, wrist- and ECG-sensor monitoring
15910059|NCT03572725|Procedure|Gas tamponade|Removal of intraocular fluid and replacement with intraocular tamponade. No restriction of postoperative positioning with exception to the supine position. A tennis ball is attached to the back of patients at night. This measure will assists them in avoiding the nocturnal supine position.
15910060|NCT03572725|Procedure|Air tamponade|Removal of intraocular fluid and replacement with intraocular tamponade. No restriction of postoperative positioning with exception to the supine position. A tennis ball is attached to the back of patients at night. This measure will assists them in avoiding the nocturnal supine position.
15910061|NCT03572712|Other|No Interventional study|every patient will be monitored with a blood gase, a nocturnal oximetry and a transcutaneous capnography
15910062|NCT03572699|Other|diabetic retinopathy|This is an observational study of patients with diabetes. Patients undergoing routine care will undergo retinal imaging using a nonmydriatic fundus camera. The images will be run on an artificial intelligence (AI) algorithm. The diagnosis of the artificial intelligence algorithm will be compared to the image diagnosis given by the ophthalmologists. The ophthalmologists will be blinded to the diagnosis of the AI and vice versa. The data will be analyzed to evaluate the performance of the AI.
15910063|NCT03572686|Drug|Ropivacaine 0.5% 20mL|In Group RH, participants received supraclavicular brachial plexus block with ropivacaine 0.5% 20ml at the end of surgery.
15910064|NCT03572686|Drug|Ropivacaine 0.25% 20ml|In Group RL, participants received supraclavicular brachial plexus block with ropivacaine 0.25% 20ml at the end of surgery.
15910065|NCT03572686|Drug|Ropivacaine 0.25% 20ml + dexamethasone 8mg|In Group RLD, participants received supraclavicular brachial plexus block with ropivacaine 0.25% 20ml + dexamethasone 8mg at the end of surgery.
15910066|NCT03572673|Device|Flexima 3S|Flexima 3S (2-piece appliance) with drainable pouch
15910067|NCT03572673|Device|New 2-piece ostomy appliance|New 2-piece ostomy appliance with drainable pouch
15910068|NCT03572660|Biological|Bone marrow derived mononuclear cells and G-CSF|Intra-coronary infusion
15910069|NCT03572647|Drug|Eritromax|The subjects will receive a single dose of 4000 IU epoetin alfa in each period, according to randomisation.
15910070|NCT03572647|Drug|Eprex|The subjects will receive a single dose of 4000 IU epoetin alfa in each period, according to randomisation.
15910071|NCT03572634|Drug|TP-0903|"Monotherapy: PHASE 1: TP-0903 will be a 25 mg flat dose. The study drug will be administered orally once daily for 28 days (each cycle is 28 days; no drug-free period).
~Patients may continue to receive TP-0903 in 28-day cycles at the same dose given during Cycle 1 until they experience unacceptable toxicity or unequivocal disease progression. No intrapatient escalation of the TP-0903 dose is permitted.
~PHASE 2: The starting dose of TP-0903 will be the RP2D determined during Phase 1. TP 0903 will be administered orally at a fixed dose once daily for 28 days (each cycle is 28 days; no drug-free period) with repeated cycles permitted until a patient experiences unacceptable toxicity or unequivocal disease progression."
15910072|NCT03572634|Combination Product|TP-0903 and ibrutinib combination therapy|"Combination therapy: PHASE 1: TP-0903 and ibrutinib combination therapy: The starting dose of TP-0903 will be a 20 mg flat dose. TP-0903 will be administered orally once daily for 28 days (each cycle is 28 days; no drug-free period). Patients will also receive ibrutinib at the same dose that they were receiving immediately prior to study enrollment.
~Patients should continue with the combination of ibrutinib and TP-0903 for at least 3 months after study start.
~PHASE 2: The starting dose of TP-0903 will be the RP2D determined during Phase 1. Patients will also receive ibrutinib at the same dose that they were receiving immediately prior to study enrollment. Both TP 0903 and ibrutinib will be administered orally at fixed doses once daily for 28 days (each cycle is 28 days; no drug-free period)."
15910073|NCT03572621|Other|Therapeutic education|"Patients will benefit from the first session of preoperative therapeutic education, then the next 5 sessions will be done postoperatively over a period of 4 month and a half.
~Session 1: The first session will be devoted appropriately to patient education. It will take place on the day of the preoperative anesthesia consultation.
~Session 2: day of discharge from hospital. Make the patient adhere to the concept of post PR erectile rehabilitation in the same way as sphincter reeducation.
~Session 3: Presentation of available treatments, start intracavernous injections.
~Session 4: Acquisition of know-how on treatment management. Reduce anxiety. Session 5: Encourage the resumption of intercourse very gradually. The presence of the partner will be advised.
~Session 6: measure of the evolution of the representations and knowledge of the patient. The skills of the patient will be evaluated from problem situations, motivation scale. The know-how will be evaluated using observation grid."
15910074|NCT03572621|Other|Collection of data concerning their sexuality|Patients in the control group are offered to participate in the study, which consists of collecting data on their sexuality. This in addition to the current care by the teams of care about erectile rehabilitation (information and medication prescriptions).
15910075|NCT03572621|Other|Participation|Participation in a therapeutic education day.
15910135|NCT03572179|Device|3d printed positioning tray|3d printed positioning tray for lingual fixed retainer placement in treatment group
15910136|NCT03572166|Diagnostic Test|Arginine infusion|Intravenous Infusion of Arginine is given, copeptin measurement will be collected before and 60minutes after start of infusion
15910137|NCT03572166|Diagnostic Test|Hypertonic saline infusion|Intravenous Infusion of hypertonic Saline is given, copeptin measurement will be collected before and once Plasma sodium rises above 149mmol/l
15910076|NCT03572608|Other|Acupuncture treatment|Classical acupuncture points will be used without a formal traditional Chinese medicine diagnosis in the intervention group. Neither manual needle stimulation nor moxibustion will used. The needles will left in place for 30 min and de qi was not sought. The points will be selected bilateral Heart-7, bilateral Large Intestine-4, Governing Vessel-20 and ear shenmen for the first session. Bilateral Conception Vessel-3,4,6, bilateral Liver-3, bilateral Stomach-30, bilateral Spleen-6, bilateral Governing Vessel-20 will be used for the second session. Bilateral Large Intestine-4, bilateral Spleen-6,9, bilateral Stomach-36 will be used for the last session. All acupuncture points will be selected and localized on the basis of the WHO Standardised Acupuncture Point Location.
15910077|NCT03572595|Diagnostic Test|F-18 FDG-PET/CT|imaging using Positron Emission Tomography/ Computed Tomography with 18F-fluoro-2-deoxyglucose (18F- FDG PET/CT) in Patients with colorectal cancer either for staging or suspecting recurrence
15910078|NCT03572582|Drug|Nivolumab|Nivolumab therapy combined with standard TACE treatment
15910079|NCT03572582|Drug|TACE|TACE is performed by using drug eluting beads
15910080|NCT03572556|Biological|Blood samples|"5 mL dry tube to separate serum
~Two 6 mL EDTA tubes for plasma separation
~Eight 6 mL heparinized tubes for flow cytometry (quantification of TANG such as CD3+CD31+CXCR4+ and CEC) and quantification of angiogenesis markers."
15910081|NCT03572556|Other|Epistaxis charts|Three monthly epistaxis charts to be completed
15910082|NCT03572543|Device|tDCS|Subjects will receive 20 minutes of multifocal transcranial direct current stimulation. The anode will be placed over the frontal pole (Fpz, 10-20 EEG) and will be surrounded by 5 return electrodes (cathodes). Current will be set at 1.5mA and will be ramped in/out at the begging and end of the 20-minutes of stimulation over the course of 30 seconds.
15910086|NCT03572517|Procedure|Subarachnoid block|Balanced general anesthesia (Induction of anesthesia: Propofol, fentanyl and rocuronium. Maintenance: Desflurane /remifentanil) associated with subarachnoid block (bupivacaine and morphine)
15910087|NCT03572517|Procedure|Spinal morphine|Balanced general anesthesia (Induction of anesthesia: Propofol, fentanyl and rocuronium. Maintenance: Desflurane /remifentanil) and spinal analgesia with morphine
15910088|NCT03572504|Other|critically ill children|Compare a series of measurement or size estimation techniques to the WHO standard to identify the most reliable method (s) of pediatric resuscitation.
15910089|NCT03572491|Biological|influenza vaccine|Allantoic split inactivated seasonal influenza vaccine
15910090|NCT03572478|Drug|Rucaparib|600 mg taken by mouth twice daily.
15910091|NCT03572478|Drug|Nivolumab|480 mg given by intravenous (IV) infusion every 4 weeks.
15910092|NCT03572465|Device|Acoustic radiation force impulse (ARFI), magnetic resonance elastography (MRE)|Acoustic Radiation Force Impulse (ARFI), Magnetic Resonance Elastography (MRE)
15910093|NCT03572452|Behavioral|McKenzie Method|Treatment according to the Mechanical Diagnosis and Therapy Approach
15910094|NCT03572452|Behavioral|Advice to saty active|Physiotherapy councelling advicing to stay normally active
15910095|NCT03572439|Diagnostic Test|Sensory block level check using ice|Patients are asked to report when the ice feels as cold as it does on the forehead.
15910096|NCT03572426|Other|genotyping all subjects|genotyping using SNaPshot genotyping method.
15910097|NCT03572413|Procedure|Low pressure pneumoperitoneum|Lowering intra-abdominal pressure during laparoscopic surgery
15910098|NCT03572413|Drug|Rocuronium bromide|Deep (PTC 1-2) versus moderate (TOF count 1-2) neuromuscular block
15910099|NCT03572400|Drug|Gemcitabine|Neoadjuvant: Weekly Gemcitabine 200 mg/m2 iv Adjuvant: Gemcitabine 1000mg/m2, D1, 8, 15 Q 4 weeks total 6cycles
15910100|NCT03572400|Drug|Durvalumab|Neoadjuvant: Durvalumab 1.5g iv Q 4weeks Adjuvant: Durvalumab 1.5g iv Q 4weeks for 1 year
15910101|NCT03572387|Drug|5-Azacitidine|subcutaneously on days 1-5 at a dose of 40 mg/m^2
15910102|NCT03572387|Drug|all trans retinoic acid|45 mg/m^2, will be taken orally on days 3-7 of each cycle, divided into two doses
15910103|NCT03572387|Drug|Lupron|7.5 mg x 1
15910104|NCT03572374|Other|TEAMWork App|"The 2-pronged approach of the intervention is operationalized through 2 menus, 1 focused on interactions with the employer and the other with the clinic team. Each menu has a list of features from which participants can choose to learn about a particular topic. A My notes button allows participants to take notes directly on the app. These notes will not be available to the research team, such that participants may use the tool without concerns about privacy. The workplace accommodations menu includes sample videos using trained actors to demonstrate how to approach an employer to request accommodations. Additional features include suggestions for accommodations that may be helpful, templates for letters participants can use when requesting accommodations, links to relevant websites, information about legal protections, and contact information for lawyers and firms that provide pro bono assistance."
15910105|NCT03572374|Other|Information Booklet|Participants in the control arm will receive a booklet that includes the information in the app that can practicably be converted to paper. These participants will not have access to the multimedia aspects of the intervention, such as the videos, but they will have all of the relevant information in the app described above, including suggestions for accommodations, written templates for letters, links to websites, information about legal protections, and contact information for pro bono legal assistance. The booklet will also contain information about chemotherapy, radiation therapy and surgery, recommendations for management of common symptoms, and advice for communicating with the clinic team. The information booklet will be provided entirely on paper, although participants may independently access websites recommended in the booklet. The booklet content will mirror the app with regard to cultural responsiveness and appropriateness for different job types and characteristics.
15910106|NCT03572361|Biological|V3-MOMMO|Tableted vaccine (V3-OVA) containing breast cancer antigens administered once daily for 3 months
15910107|NCT03572348|Procedure|Transecting anastomotic repair (tAR)|Classic technique, which involves full thickness transection of the corpus spongiosum and the embedded urethral blood supply.
15910108|NCT03572348|Procedure|Vessel-sparing anastomotic repair (vsAR)|Alternative technique, leaving the bulbar arteries intact, only transecting and excising the narrow segment of the urethra and the surrounding spongiofibrosis.
15910109|NCT03572335|Diagnostic Test|PFT's (pulmonary function testing)|The routine lung function endpoints of FVC(forced vital capacity), FEV1, FEV1/FVC, and FEF25-75% will be measured with the flow-volume loop recorder before and after bronchodilator administration. The system is calibrated for body temperature and pressure of saturated gas and volumes, per American Thoracic Society (ATS) standards . DLco will be measured using the automated single-breath procedure of the integrated testing system, which conforms with ATS standards.
15910110|NCT03572322|Other|Focus Group|Focus Group
15910111|NCT03572322|Other|Interviews|Interviews
15910112|NCT03572296|Dietary Supplement|Placebo|Drinks will be delivered in random order at 3 separate study visits immediately before a high carbohydrate meal. A minimum of 4 days (ideally 7 days) wash-out period will be required between study days.
15910113|NCT03572296|Dietary Supplement|Polyphenol and fibre|Drinks will be delivered in random order at 3 separate study visits immediately before a high carbohydrate meal. A minimum of 4 days (ideally 7 days) wash-out period will be required between study days.
15910114|NCT03572296|Dietary Supplement|Fibre|Drinks will be delivered in random order at 3 separate study visits immediately before a high carbohydrate meal. A minimum of 4 days (ideally 7 days) wash-out period will be required between study days.
15910115|NCT03572283|Drug|Bethanechol|Supplied as 50mg oral tablets. Take 2 tablets (total 100mg) twice daily from day 1 for a minimum of 1 week and a maximum of 4 weeks (or 2 days prior to scheduled surgery). Medication should be taken 1 hour before meals in the morning and the evening. Although bethanechol is FDA approved, in this study its use is experimental.
15910116|NCT03572270|Diagnostic Test|AMH test|Blood test and pelvic ultrasound are performed at each visit to evaluate ovarian reserve
15910117|NCT03572270|Diagnostic Test|pelvic ultrasound|Blood test and pelvic ultrasound are performed at each visit to evaluate ovarian reserve
15910118|NCT03572257|Drug|Quetiapine|Patients randomized to the study treatment group will received quetiapine at 0.5 mg/kg, three times a day for 10 days. Doses can be increased up to a maximum of 6 mg/kg/day, in increments of 0.5 mg/kg, based on the subject's clinical delirium symptoms. PRN doses of 0.5 mg/kg can be given up to three times a day based on the clinical judgement of the subject's ICU care team.
15910119|NCT03572257|Other|Placebo|Patients randomized to the placebo group will be given an equivalent volume of sterile liquid or sugar pill, based on the individual subjects dosing preference or ability. Dosing will be done on the same schedule as the quetiapine group
15910120|NCT03572244|Device|Laser-Lok|A microgrooved abutment will be placed
15910121|NCT03572244|Device|Machined|A machined transmucosal healing abutment will be placed
15910122|NCT03572231|Drug|mirabegron|oral
15910123|NCT03572231|Device|solifenacin|oral
15910124|NCT03572231|Drug|darifenacin|oral
15910125|NCT03572231|Drug|imidafenacin|oral
15910126|NCT03572231|Drug|tolterodine|oral
15910127|NCT03572231|Drug|oxybutynin|oral
15910128|NCT03572231|Drug|trospium|oral
15910129|NCT03572231|Drug|fesoterodine|oral
15910130|NCT03572231|Device|propiverine|oral
15910131|NCT03572218|Behavioral|BWL|The BWL sessions will be based on the Diabetes Prevention Program (DPP) manual. A diet of 1200-1499 calories per day will be prescribed for participants < 250 lb, and 1500-1800 for those ≥ 250 lb. Participants will be instructed to eat a balanced deficit diet. Session topics during the first 12 weeks will include self-monitoring, stimulus control, slowing eating, social support, cognitive restructuring, portion sizes, and goal-setting. Those during weeks 13-26 will focus on continued self-monitoring and skills required for weight loss maintenance and relapse prevention. Physical activity will be prescribed at a level consistent with data showing that >250 min/wk is associated with improved long-term weight loss. BWL sessions will last 60 minutes.
15910132|NCT03572218|Behavioral|BIAS|Following 60 minutes of BWL treatment, the BIAS intervention will devote 30 minutes to stigma-related content. Session topics will include: psychoeducation about weight and weight stigma; challenging myths and cognitive distortions related to weight; strategies for coping with instances of stigma; and increasing empowerment and body esteem. The effects of weight stigma on health behaviors will be discussed, and sessions will focus specifically on helping participants overcome stigma-related barriers to weight management. In the every-other-week and monthly weight loss maintenance sessions from weeks 13-26, strategies for coping with weight stigma and challenging internalized beliefs will be reviewed, and participants will be encouraged to use these strategies in the context of weight management.
15910133|NCT03572205|Dietary Supplement|LA|The source of linoleic acid (LA) will be sunflower oil (62-63 % LA). The study diets will be isocaloric. The allowed weight change during the study is ± 2-3 %. The amount of supplementary oil will be calculated individually based on the calculated energy expenditure and adjusted, if necessary, during the study based on body weight measurements.
15910134|NCT03572205|Dietary Supplement|ALA|The source of alpha-linolenic acid (ALA) will be camelina sativa oil (30-35 % ALA). The study diets will be isocaloric. The allowed weight change during the study is ± 2-3 %. The amount of supplementary oil will be calculated individually based on the calculated energy expenditure and adjusted, if necessary, during the study based on body weight measurements.
15910138|NCT03572153|Behavioral|Self-Administered Hypnosis|Participants will be listening to six 20-minute hypnosis audio recordings with hypnotic induction. Participants will be encouraged to practice daily, and each recording will build on the content of the previous recordings. They will also be provided with booklets of information about hot flashes, including treatment options.
15910139|NCT03572153|Behavioral|Self-Administered White Noise Hypnosis|Participants will be listening to the same 20-minute white noise audio recordings for 6 weeks and will be encouraged to practice daily.They will also be provided with booklets as well as an audio recording with information about hot flashes including treatment options.
15910140|NCT03572140|Diagnostic Test|RAVS In relapsed and resistent cases|assessment of RAVS in relapsed and resistant cases after sofosbuvir plus daclatasvir regimen
15910141|NCT03572127|Other|Diet|High protein diet derived from either animal or non-animal sources.
15910142|NCT03572114|Diagnostic Test|3Tesla MRI|"A previously validated multi-parameter mapping protocol sensitive to neuromelanin and iron content
~Iron mapping and micro-bleed detection: QSM (quantitative susceptibility mapping), a fully flow-compensated, susceptibility-weighted gradient-echo sequence (5 minutes).
~1-mm isotropic anatomical MPRAGE (magnetization-prepared rapid gradient-echo)
~conventional FLAIR sequence"
15910143|NCT03572114|Behavioral|Burke-Fahn-Marsden Dystonia Rating scale|internationally standardized examination/quantification of dystonia
15910144|NCT03572114|Behavioral|MDS-United Parkinsons Disease Rating Scale, Part III|most recent, internationally standardized examination/quantification of bradykinesia / rigidity according to the Movement Disorder Society
15910145|NCT03572114|Behavioral|Beck Depression Inventory|internationally standardized examination to quantify traits of anxiety and depression
15910146|NCT03572114|Behavioral|MoCA: Montreal Cognitive Assessment:|internationally standardized examination to quantify cognition, frequently used in studies of dystonia and parkinsonism
15910147|NCT03572088|Drug|Terlipressin|Terlipressin is a synthetic vasopressin analogue with relative specificity for the splanchnic circulation(Terlipressin was started at the beginning of surgery as an initial bolus dose of 1 mg over 30 mints(1 mg/50 ml normal saline at a rate of 100 ml/h) followed by a continuous infusion of 2 μg/kg/h(1 mg/50 ml at a rate equal to wt/10 ml per hour) and weaned in the postoperative period over 4 hours.)
15910148|NCT03572088|Drug|normal saline|Patients received 50 ml normal saline at a rate of 100 ml/h followed by a continuous infusion of 50 ml at a rate equal to wt/10 ml per hour and weaned in the postoperative period over 4 hours.
15910149|NCT03572075|Diagnostic Test|assessment of symptoms at the first medical examination|assessment of endometriosis related symptoms using NRS (Numerical Rating Scale); intestinal, sexual and urinary functions are evaluated with validated questionnaires (Knowles-Eccersley-Scott-Symptom Questionnaire (KESS), Female Sexual Function Index (FSFI), Bristol Female Lower Urinary Tract Symptoms (BFLUTS)); pelvic floor morphometry at rest, during pelvic floor contraction and during Valsalva manoeuvre is evaluated using 3D/4D transperineal ultrasound through the assessment of the levator hiatus area (LHA) at the first medical examination
15910150|NCT03572075|Procedure|pelvic floor physiotherapy|six individual sessions (weeks 1, 3 , 5, 8, 11 from the randomization) with pelvic floor consciousness exercises with mild contractions and relaxation (ex. 'kegel reverse' exercises); respiratory rate control exercises; extra exercises to perform at home are suggested.
15910151|NCT03572075|Procedure|standard care protocol|the treatment is the same as usual in our center
15910152|NCT03572075|Diagnostic Test|assessment of symptoms after four months|assessment of endometriosis related symptoms using NRS (Numerical Rating Scale); intestinal, sexual and urinary functions are evaluated with validated questionnaires (Knowles-Eccersley-Scott-Symptom Questionnaire (KESS), Female Sexual Function Index (FSFI), Bristol Female Lower Urinary Tract Symptoms (BFLUTS)); pelvic floor morphometry at rest, during pelvic floor contraction and during Valsalva manoeuvre is evaluated using 3D/4D transperineal ultrasound through the assessment of the levator hiatus area (LHA) after four months from the randomization.
15910153|NCT03572062|Biological|Formulation A|RSV vaccine
15910154|NCT03572062|Biological|Formulation B|Adjuvanted RSV vaccine
15910155|NCT03572062|Biological|Formulation C|RSV vaccine
15910156|NCT03572062|Biological|Placebo|Placebo
15910157|NCT03572049|Drug|SUBA itraconazole|SUBA itraconazole study drug will consist of two 65 mg capsules to be taken three times a day with food for days 1-3 of study. For days 4-180 of study, two 65mg capsules will be taken twice daily with food.
15910158|NCT03572049|Drug|Conventional itraconazole|Conventional itraconazole comparator drug will consist of two 100 mg capsules to be taken three times a day with food for days 1-3 of study. For days 4-180 of study, two 100 mg capsules will be taken twice daily with food.
15910159|NCT03572023|Other|Integrative characterization of MINOCA patients|"Characterization of MINOCA patients will be based on integrative evaluation of imaging data, blood levels of proinflammatory and anti-inflammatory cytokines, and genetic testing for thrombophilia risk.
~MSCT: Imaging for the presence and vulnerability of coronary plaque as well as plaque disruption.
~CMR: Imaging for identification of myocardial injury (late gadolinium enhancement and myocardial edema) as well as other concomitant findings.
~SPECT: Single-Photon Emission Computed Tomography enable assessment of myocardial perfusion and viability.
~Blood tests.
~Genetic tests."
15910160|NCT03572023|Other|Characterization of MI patients with coronary obstruction|"Characterization of patients with myocardial infarction and obstructive atherosclerosis will be based on integrative evaluation of imaging data, blood levels of proinflammatory and anti-inflammatory cytokines, and genetic testing for thrombophilia risk.
~MSCT: Imaging for the presence and vulnerability of coronary plaque as well as plaque disruption.
~CMR: Imaging for identification of myocardial injury (late gadolinium enhancement and myocardial edema) as well as other concomitant findings.
~SPECT: Single-Photon Emission Computed Tomography enable assessment of myocardial perfusion and viability.
~Blood tests.
~Genetic tests."
15910161|NCT03572010|Dietary Supplement|FeFum fortified maize test meal|Maize porridge extrinsically labeled with 2 mg ferrous fumarate (58FeFum); only for iron deficient children (defined by plasma ferritin <40 mikrogramm/L and/or sTfR >8.3 mg/L); cereal staple foods, like maize, depending on milling, may be high in phytic acid, a potent iron absorption inhibitor
15910334|NCT03570801|Other|Expert Panel Review|There is some preliminary evidence suggesting that having a group of spinal experts review x-rays prior to treatment might provide useful information to the patient and the patients' treating physician when trying to make a decision about what type of surgery to perform.
15910335|NCT03570788|Procedure|Amputation|Major amputation defined as at or above ankle
15910162|NCT03572010|Dietary Supplement|FeSO4 fortified LNS|self-made Lipid-based nutritional supplement (LNS) extrinsically fortified and labeled with 6 mg ferrous sulfate (57FeSO4); only for iron deficient children (defined by plasma ferritin <40 mikrogramm/L and/or sTfR >8.3 mg/L); LNS may be a better food matrix for iron supplementation compared to maize-based porridge; contains canola oil, peanut paste, milk powder, sugar, maltodextrin and palm stearin
15910163|NCT03572010|Dietary Supplement|FeSO4 supplement|170 mg iron tablets as FeSO4 (containing 55 mg of elemental iron) with 6 mg extrinsically labeled 57Fe; will be given together with a glass of water; only for iron deficient children (defined by plasma ferritin <40 mikrogramm/L and/or sTfR >8.3 mg/L);
15910164|NCT03572010|Dietary Supplement|FeSO4 fortified fruit juice|Fruit juice labeled with 12 mg 57Fe as FeSO4; in the group for iron sufficient children
15910165|NCT03571984|Behavioral|Moving on ABC Plus|The intervention has two components. CBT Moving on After Breast Cancer
15910166|NCT03571971|Other|Load modification education|Load modification education includes exercises currently prescribed by physical therapists, like stretching and strengthening activities, but will also include education on common daily postures and movement patterns that may increase load and stress on the muscles and tendons around the hip.
15910167|NCT03571971|Other|Standard exercise education|Standard exercise education includes exercises currently prescribed by physical therapists, like stretching and strengthening activities.
15910168|NCT03571958|Behavioral|BMI|A derivative of motivational interviewing (MI), which is a patient-centered, collaborative counseling approach to strengthen an individual's intrinsic motivation towards a positive behavior change. BMI is intended for healthcare providers with limited time (5-10 minutes) to support a positive behavior change.
15910169|NCT03571945|Device|Bi-spectral Index (BIS QUATRO REF #186-0106)|GA will be monitored and controlled with Bi-spectral index (BIS).
15910170|NCT03571945|Device|End tidal anaesthesia gas concentration (ETAG)|GA will be monitored and controlled with end-tidal anaesthesia gas concentration
15910171|NCT03571932|Behavioral|Family planning and immunization service integration|The approach involved integration of immunization and family planning services at health facilities. Vaccinators provided brief FP messages one-on-one to mothers and offered a referral for same-day, co-located FP services at the end of each routine immunization visit. For women coming directly for FP, if women had an infant with them, FP providers asked to see the child's health card, checked the return date for the next vaccination and reminded the mother of the date to return. For women without their child or the child health card with them, FP providers reinforced the importance of vaccination, and encouraged the mothers to bring their child for all their vaccines and complete the immunization schedule in a timely manner. A job aid, referral cards, and IEC materials were introduced to support the integration process.
15910172|NCT03571919|Drug|Lidocaine infusion|Intravenous bolus of lidocaine (1.25 mg/kg) and then infusion at 1 mg/kg/hr
15910173|NCT03571919|Drug|Saline infusion|Intravenous bolus of saline and then infusion
15910174|NCT03571906|Behavioral|Tele - Cardiac Pre-Rehabilitation|We intend to enroll 50 stable subjects with valvular heart disease scheduled for surgical intervention. Following a comprehensive clinical and physiological evaluation subjects will be randomized (1:1) to a Prehab arm (PHB) vs. usual care (UC). Subjects in the prehab arm will receive a hybrid institution and home-based exercise prescription, nutritional and psychological intervention and periodic calls. Adherence will be assessed and encouraged by smartwatch and matching smartphone software. In the usual care arm subjects will receive general recommendations following the baseline stress test performed by both groups (prehab is not standard of care or guideline based). Another stress test will be performed days prior to valve surgery Adherence to the rehab program will be assessed and a structured motivational program and follow-up will be provided in order to maximize goal completion.
15910175|NCT03571893|Behavioral|Weight Watchers Freestyle (Flex)|Participants will be referred to their local Weight Watchers meeting and provided with a promotional code to allow them to participate in the Weight Watchers program free of charge for 12 months. At the randomization visit, study staff will help participants identify a convenient Weight Watchers meeting location and download the program app onto their smartphone.
15910176|NCT03571893|Behavioral|DIY Personal Plan|Participants will be provided with a written resource with descriptions of a variety of approaches that have been shown to promote healthy weight loss through behavioral modification. Participants will be encouraged to assess their preferences for dietary change and physical activity and adopt an approach that will lead to negative energy balance and moderate (1-2 lbs. per week) weight loss.
15910177|NCT03571880|Device|Biodex-assisted isometric strength testing|The maximum voluntary isometric and dynamic strength of back and abdominal muscles is measured using an isokinetic dynamometer (System 3, Biodex, Enraf-Nonius, New York).
15910178|NCT03571854|Device|Group PCV-VG|Pressure controlled ventilation-volume guaranteed
15910179|NCT03571854|Device|Group VCV|Volume controlled ventilation
15910180|NCT03571841|Behavioral|Group Session|The 4-hour group session will be structured around three 60-minute modules and creation of a personal action plan
15910181|NCT03571841|Behavioral|Telephone Booster|One month following the group session, women will receive a telephone booster session (<15 minutes). This brief telephone check-in is intended to help women review progress with their individualized action-plan, problem-solve around continuing problems, and plan for maintenance moving forward.
15910182|NCT03571828|Drug|AMG 562|AMG 562 is a BiTE® antibody construct that targets CD19 and is intended for the treatment of patients with B-cell malignancies.
15910183|NCT03571815|Drug|5% sodium fluoride varnish|application of sodium fluoride varnish on teeth
15910184|NCT03571815|Other|WATER ON TEETH|control group
15910185|NCT03571802|Drug|Simvastatin|"The subject will take simvastatin 20mg at 0 h (after stopping simvastatin for 5 days). 5 mL of blood will be sampled at 0 h, 1 h, 2 h, 3 h, 5 h, 7 h.
~There will be 2 blood sampling sessions: 1 before and the other 3 months after surgery."
15910186|NCT03571789|Device|Vine™|"The Vine™ is made of a super-elastic nitinol wire comprises a helix that resides within the CCA lumen and a linear stem that traverses the CCA wall. The helix includes three segments: supporting coils, filter, and leading coils.
~The device is available in sizes of 6.0mm - 10.0mm (in 0.5mm intervals) to accommodate individual CCA diameters"
15910187|NCT03571776|Procedure|Surgery|Laparoscopic ovarian cystectomy
15910188|NCT03571776|Procedure|Sclerotherapy|US-aspiration and alcohol sclerosis
15910189|NCT03571763|Other|SWI sequence|Acute ischemic stroke patient confirmed by SWI sequence
15910190|NCT03571750|Behavioral|Building Stronger Allies|"BSA was developed to model the educational and behavioral techniques commonly employed in the treatment of individuals with mood psychopathology. The psychoeducation portion uses Cognitive Behavioral Therapy principles to correct problematic ideas and behaviors related to PB/TB. More specifically, the program was designed to correct myths regarding PB/TB. The program emphasizes the idea that social interaction is a critical need, just like other basic needs such as the need for food and water. Participants are taught that negative beliefs about being isolated and being a burden are usually inaccurate. Following this, behavioral activation techniques are introduced as a way to decrease isolation and feelings of burdensomeness."
15910191|NCT03571750|Behavioral|Health Education Training|In the HET condition, participants will spend approximately the same amount of time with a program that will present information regarding the importance and benefits of a maintaining a healthy lifestyle and then will provide guidelines to achieve a healthy lifestyle. HET is shown to engage participants with beneficial information while being inert with respect to the risk mechanisms of interest (i.e., PB/TB). The program covers a number of health related topics including: diet, alcohol use, water consumption, exercise, and sleep. The program reviews with the Participants how to monitor their own daily health habits, which will be reinforced by the Smartphone application.
15910192|NCT03571737|Drug|Ibuprofen|Ibuprofen tablet
15910193|NCT03571737|Drug|Lidocaine Patch 4%|Lidocaine patch
15910194|NCT03571724|Other|Non-Menthol Very Low Nicotine Cigarettes|King size non-menthol cigarettes containing 0.4mg nicotine /g tobacco
15910195|NCT03571724|Other|Menthol Very Low Nicotine Cigarettes|King size menthol cigarettes containing 0.4mg nicotine /g tobacco
15910196|NCT03571724|Other|Subject's UB non-mentholated filtered cigarettes|King size non-menthol cigarettes
15910197|NCT03571724|Other|Subject's UB mentholated filtered cigarettes|King size menthol cigarettes
15910198|NCT03571711|Drug|Meropenem Injection|Meropenem is administered as prescribed by treating physician
15910199|NCT03571698|Device|Neuromuscular Electrical Stimulator|The treatment group received exercise programme with simultaneously active contraction with NMES with large or standart electrodes.
15910200|NCT03571685|Behavioral|Sustainable Early Episode Clinic Model of Care|The first 8 weeks is the education phase. Participants attend classes every week for up to 6 hours. From 9 weeks to 10 months participants attend classes for 5 hours every other week. Based on individual progress. Participants can move to the maintenance phase. This phase provides minimal intervention but ongoing support/evaluation.
15910201|NCT03571672|Drug|DEFINITY|All subjects will receive a single dose of DEFINITY®
15910202|NCT03571659|Procedure|Laser|
15910203|NCT03571646|Behavioral|Capnostream 20 monitoring|Continuous monitoring on a general ward
15910204|NCT03571646|Device|PM1000N-RR monitoring|Continuous monitoring on a general ward
15910205|NCT03571633|Drug|Trastuzumab + Paclitaxel|During neoadjuvant period, weekly paclitaxel + trastuzumab (every 3 weeks, Q3W) During adjuvant period, weekly trastuzumab (every 3 weeks, Q3W)
15910206|NCT03571633|Drug|Pegfilgrastim|During neoadjuvant period, weekly pegfilgrastim (every 3 weeks, Q3W)
15910207|NCT03571620|Drug|Q301 Cream|1.0% or 1.4% Q301 Cream
15910208|NCT03571620|Drug|Vehicle|Vehicle Control
15910209|NCT03571607|Biological|13-valent pneumococcal conjugate vaccine|A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.
15910210|NCT03571594|Drug|ONO-5788|Investigational drug
15910211|NCT03571594|Drug|ONO-5788 Placebo|Placebo Comparator
15910212|NCT03571594|Drug|Octreotide|Active Comparator in Part D
15910213|NCT03571581|Behavioral|Mindfulness Training (MT)|Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
15910214|NCT03571568|Biological|BI1206|375 mg/m2, as per SmPC
15910215|NCT03571555|Behavioral|Sentebale Psychosocial Programme|Residential interventions (camps) for the young people, and community based support (clubs) for the young people and the caregivers.
15910216|NCT03571542|Other|pulmonary function|The aim of this study is to assess the respiratory function thanks to pulmonary function tests in renal transplanted children in France.
15910217|NCT03571529|Device|EMG-driven exoskeleton hand robot|"Primary Outcome Measurement:
~1. Fugl-Meyer Upper Extremity Assessment
~Secondary Outcome Measurements:
~Action Research Arm Test
~Motor Activity Log
~Data from force and EMG measurement records of HOH robot
~Grip strength (with hand dynamometer)
~Range of motion measurements of Wrist, and MCP, PIP and DIP joints of the fingers
~Manuel muscle testing for wrist and finger muscles.
~Modify Asworth sclale At the beginning of each robotic treatment session, superficial EMG recording will be taken at relax position ( without muscle contraction) and then during maximal voluntary isometric contraction (MVC) after the patient's hand is placed in the exoskeleton. For both, EMG recording is performed for 7 seconds and Root Mean Square (RMS) is calculated from this record."
15910218|NCT03571529|Other|Conventional physiotherapy|"Primary Outcome Measurement:
~1. Fugl-Meyer Upper Extremity Assessment
~Secondary Outcome Measurements:
~Action Research Arm Test
~Motor Activity Log
~Data from force and EMG measurement records of HOH robot
~Grip strength (with hand dynamometer)
~Range of motion measurements of Wrist, and MCP, PIP and DIP joints of the fingers
~Manuel muscle testing for wrist and finger muscles.
~Modify Asworth sclale"
15910219|NCT03571516|Drug|Teduglutide|SC injection of 0.05 mg/kg teduglutide will be administered QD into abdomen or into either the thigh or arm for 24 weeks.
15910220|NCT03571516|Other|Standard Medical Therapy|Standard medical therapy will be administered for 24 weeks.
15910221|NCT03571516|Device|Syringe|Teduglutide will be administered using syringe (510k number: K980987).
15910222|NCT03571516|Device|Needle|Teduglutide will be administered using needle (510k number: K021475).
15910325|NCT03570853|Behavioral|SMART-3RP|This is an 8-week, multimodal resiliency program that targets stress with 4 main components: mind-body skills (participants learn a variety of meditation techniques, mini relaxations, walking meditation, and yoga), traditional stress management techniques, healthy lifestyle behaviors (sleep, exercise, nutrition, and social support), and cognitive reappraisal and adaptive coping skills (borrowed from cognitive behavioral therapy, acceptance and commitment therapy, and positive psychology). The program consists of 8, 1.5 hour sessions.
15910223|NCT03571503|Procedure|Doin (conduction exercise)|An acupuncture physician will administer acupuncture at 4-8 acupoints in the low back and gluteal area (mandatory points: BL54, and GB30 ipsilateral to the dysfunctional site; and selective points: BL23, BL24, BL25, BL26, BL31, BL32, Ah-shi points, local acupuncture points and/or trigger points. Doin (conduction exercise) will be performed as active and passive movement with the needles in situ to the aim of effective treatment of pain and functional disability by increasing the hip joint range of motion (flexion and extension) with physician guidance and isometric resistance exercise (flexion and extension) as needed. Doin (conduction exercise) sessions will be performed 1 session/day for the duration of hospitalized treatment while the patient presents radiating leg pain (NRS≥1).
15910224|NCT03571503|Drug|Herbal medicine|Herbal medicine will be mainly administered in water-based decoction (120ml) and dried powder (2g) form (the ingredients are mainly, but not restricted to: Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, Saposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycine max, Atractylodes japonica).
15910225|NCT03571503|Procedure|Chuna manual therapy|Chuna is a Korean spinal manipulation that incorporates spinal manipulation techniques for joint mobilization involving high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement. Chuna manipulation will be administered at the physician's discretion.
15910226|NCT03571503|Procedure|Bee venom pharmacopuncture|Bee venom pharmacopuncture will be administered only after confirming a negative response to hypersensitivity skin test. Diluted bee venom (saline:bee venom ratio, 10,000:1) filtered for allergens will be injected at 4-5 acupoints proximal to the dysfunctional site at the physician's discretion. Each acupuncture point will be injected to a total of 0.5-1 cc using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
15910227|NCT03571503|Procedure|Pharmacopuncture|Pharmacopuncture consisting of select herbal ingredients will be administered at Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
15910228|NCT03571503|Procedure|Acupuncture|Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
15910229|NCT03571503|Procedure|Electroacupuncture|Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
15910230|NCT03571503|Procedure|Cupping|Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.
15910231|NCT03571503|Other|Other intervention(s)|Patients will be allowed any other additional intervention(s) as deemed necessary by the attending physician regardless of type or dose, and patterns of use will be investigated and recorded as an pragmatic clinical study.
15910232|NCT03571490|Drug|Ropivacaine|Single shot of ropivacaine 0.325%
15910233|NCT03571490|Drug|Saline|Single shot of saline 0.9%
15910234|NCT03571477|Device|ApneaBand|Mesure of oxygen saturation (oximetry), pulse wave (photoplethysmography), electrodermal activity and movements (tri-axial accelerometer)
15910235|NCT03571464|Device|GGRO Mobile App|"GGRO was designed to challenge maladaptive beliefs that underlie common OCD symptoms (e.g., contamination, repugnant thoughts) as well as relationships obsessions. Users are presented with 'blocks' featuring statements such as I take things as they come or Everything can end in a catastrophe. Users then have to respond to these statements by either pulling 'blocks' towards themselves (i.e., downwards) or throwing the blocks away from themselves (i.e., rejecting them upwards)."
15910236|NCT03571438|Combination Product|CK2 and ATM inhibitors serine/ threonin Kinase combination|Treatment of cell culture with CK2 and ATM inhibitors serine/ threonin Kinase combination
15910237|NCT03571438|Drug|Sunitinib|Treatment of cell culture with Sunitinib
15910238|NCT03571438|Drug|Pazopanib|Treatment of cell culture with Pazopanib
15910239|NCT03571438|Drug|Temsirolimus|Treatment of cell culture with Temsirolimus
15910240|NCT03571425|Other|Oral Placebo|A placebo beverage will be consumed orally
15910241|NCT03571425|Other|Oral Protein|A protein beverage will be consumed orally
15910242|NCT03571425|Other|Enteral Protein|A protein beverage will be consumed via a naso-gastric feeding tube
15910243|NCT03571412|Device|repetitive Transcranial Magnetic Stimulation|Subject will receive 5Hz LDLPFC or 5Hz DMPFC rTMS
15910244|NCT03571386|Behavioral|Mindfulness-based Cognitive Therapy (MBCT)|Standardized 8-week Cognitive and Behavioral Psychotherapy group with 26 hrs of in-class training and homework, along with 1 all-day retreat in which core mindfulness skills are developed
15910245|NCT03571386|Behavioral|Mindfulness-based Stress Reduction (MBSR)|Standardized 8-week patient-centered educational approach which uses relatively intensive training in core meditation practices that teaches people how to take better care of themselves using mindfulness skills and live healthier and more adaptive lives.
15910246|NCT03571373|Other|No intervention|No intervention due to the observational set-up of this study.
15910247|NCT03571360|Other|PD-L1 positive vs PD-L1 negative NSCLC patients|Genomic analyses of PD-L1 positive vs PD-L1 negative NSCLC patients
15910248|NCT03571347|Behavioral|Self Help Plus|5-session psychosocial intervention
15910249|NCT03571347|Other|Enhanced Treatment As Usual|Routine social support and/or care, and information about freely available mental health services, social services, NGOs, and community networks providing support to asylum seekers and refugees
15910250|NCT03571334|Drug|IncobotulinumtoxinA (Xeomin®, Merz) (INA)|IncobotulinumtoxinA (Xeomin®, Merz) (INA) will be reconstituted with preservative-free normal saline to a dilution of 5mL:100 units. Study participants will receive 50u INA (total volume 2.5mL) injected into each limb, max 2 limbs per subject (either bilateral hands or bilateral feet.) Study participants will receive one series of injections during the trial. In the hands, INA will be injected across the palmar surface of the digits in a grid like pattern covering a total of 25 sites per limb (0.1mL/site). In the feet, INA will be injected across the dorsal surface of the foot in a grid like pattern covering a total of 25 sites per limb (0.1mL/site). Injections will be performed intradermally using a 5/16-inch, 32-g needle
15910326|NCT03570827|Drug|Androgen Suppression|Given androgen suppression therapy
15910327|NCT03570827|Radiation|Hypofractionated Radiation Therapy|Undergo hypofractionated radiation therapy
15910328|NCT03570827|Other|Quality-of-Life Assessment|Ancillary studies
15910329|NCT03570827|Other|Questionnaire Administration|Ancillary studies
15910251|NCT03571334|Drug|Normal saline|Study participants will total volume 2.5mL of 0.9% Normal saline injected into each limb, max 2 limbs per subject (either bilateral hands or bilateral feet.) Study participants will receive one series of injections during the trial. In the hands, 0.9% Normal saline will be injected across the palmar surface of the digits in a grid like pattern covering a total of 25 sites per limb (0.1mL/site). In the feet, 0.9% Normal saline will be injected across the dorsal surface of the foot in a grid like pattern covering a total of 25 sites per limb (0.1mL/site). Injections will be performed intradermally using a 5/16-inch, 32-g needle
15910252|NCT03571321|Drug|Ruxolitinib|"Participants will receive one of 3 doses [taken by mouth] (30 mg, 40 mg, or 50 mg) depending on when they are enrolled to the study.
~Remission consolidation regimen:
~Days 1-14 and 29-43
~Interim maintenance regimen:
~Days 1-14 and 29-43
~Delayed Intensification regimen:
~Days 1-14 and 29-43"
15910253|NCT03571321|Drug|Cyclophosphamide|"Remission consolidation regimen:
~1000 mg/m2 by intravenous infusion (IV) on Day 1 and Day 29
~Delayed Intensification regimen:
~1000 mg/m2 IV on Day 29"
15910254|NCT03571321|Drug|Cytarabine|"Remission consolidation regimen:
~75 mg/m2/day IV or subcutaneously (SC) on Days 1-4 (i.e., 4 doses), 8-11, 29-32, and 36-39
~Delayed Intensification regimen:
~75 mg/m2/day IV or SC on Days 29-32 and 36-39"
15910255|NCT03571321|Drug|Mercaptopurine|"Taken by mouth.
~Remission consolidation regimen:
~60 mg/m2 on Days 1-14 and 29-42
~Maintenance Therapy:
~75 mg/m2 on Days 1-84"
15910256|NCT03571321|Drug|Vincristine|"Remission consolidation regimen:
~1.5 mg/m2 (maximum 2 mg) IV once per week on Days 15, 22, 43, and 50
~Interim maintenance regimen:
~1.5 mg/m2 (maximum 2 mg) IV on Days 1, 11, 21, 31, and 41
~Delayed Intensification regimen:
~1.5 mg/m2 (maximum 2 mg) IV on Days 1, 8, 15, 43, and 50
~Maintenance Therapy:
~1.5 mg/m2 (maximum 2 mg) IV on Days 1, 29, and 57"
15910257|NCT03571321|Drug|Pegaspargase|"Remission consolidation regimen:
~2500 IU/m2 given by intramuscular (IM) injection or IV on Days 15 and 43
~Interim maintenance regimen:
~2500 IU/m2 IM or IV on Days 2 and 22
~Delayed Intensification regimen:
~2500 IU/m2 IM or IV on Day 4 (OR Day 5 OR Day 6) AND Day 43."
15910258|NCT03571321|Drug|Rituximab|"For patients that have cluster of differentiation antigen 20 positive (CD20+) disease only.
~Remission consolidation regimen:
~375 mg/m2 IV on Days 1, 8, 29 and 36
~Interim maintenance regimen:
~375 mg/m2 IV on Days 1 and 11
~Delayed Intensification regimen:
~375 mg/m2 IV on Days 1 and 8"
15910259|NCT03571321|Drug|Methotrexate (Intrathecal Administration)|"Drug is given through a needle which is inserted in one of the spaces between the bones in the lower back (intrathecal [IT] administration).
~Remission consolidation regimen:
~15 mg on Days 1, 8, 15, and 22
~Interim maintenance regimen:
~15 mg on Days 1 and 31
~Delayed Intensification regimen:
~15 mg on Days 1, 29, and 36
~Maintenance Therapy:
~15 mg on Day 1
~15 mg on Day 29 (First 4 courses only)"
15910260|NCT03571321|Drug|Methotrexate (Intravenous Administration)|"Interim maintenance regimen:
~100 mg/m2 IV on Days 1, 11, 21, 31, and 41"
15910261|NCT03571321|Drug|Dexamethasone|"Taken by mouth or given by IV infusion.
~Delayed Intensification regimen:
~10 mg/m2 per day (divided into 2 doses) on Days 1-7 and 15-21
~Maintenance Therapy:
~6 mg/m2 per day (divided into 2 doses) on Days 1-5, 29-33, and 57-61"
15910262|NCT03571321|Drug|Doxorubicin|"Delayed Intensification regimen:
~25 mg/m2 IV on Days 1, 8, 15"
15910263|NCT03571321|Drug|Thioguanine|"Taken by mouth at least 1 hour after evening meal.
~Delayed Intensification regimen:
~60 mg/m2 on Days 29-42"
15910264|NCT03571321|Drug|Methotrexate Oral Product|"Taken by mouth.
~Maintenance Therapy:
~20 mg/m2 weekly (on Days 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78)
~Not given on Day 29 of first 4 courses (on days when IT Methotrexate is given]"
15910265|NCT03571308|Drug|R-CHOP + acalabrutinib|Patient will be given R-CHOP and acalabrutinib
15910266|NCT03571295|Device|King Vision aBlade|endotracheal intubation performed with King Vision aBlade
15910267|NCT03571295|Device|direct laryngoscopy|endotracheal intubation performed with direct laryngoscopy
15910268|NCT03571282|Drug|conbercept|After three monthly injections of conbercept, if no effects was seen in the patients, the patients will receive rescue treatments such as photodynamic therapy (in the macular) or laser photocoagulation (outside the macular).
15910269|NCT03571269|Procedure|Optical coherence tomography-guided reperfusion strategy|Optical coherence tomography will be used to detect the detailed characteristics of culprit lesion and to decide and optimize the reperfusion strategy according to the established algorithm in the protocol.
15910270|NCT03571256|Drug|TEV-50717|6-, 9-, 12-, 15-, and 18 mg oral tablets
15910271|NCT03571256|Drug|Placebo|Placebo matched to TEV-50717 tablets will be taken BID.
15910272|NCT03571243|Other|no intervention|observational study
15910273|NCT03571230|Drug|two sensitive antibiotics(amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline)|Patients will receive a 10-day triple therapy for the H.pylori eradication. The regimen contains one PPI and two sensitive antibiotics determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole, levofloxacin, furazolidone and tetracycline will be evaluated.
15910274|NCT03571230|Drug|two antibiotics based on personal medication history(amoxicillin,clarithromycin,furazolidone)|Patients will receive a 14-day bismuth-based quadruple therapy for the H.pylori eradication. The regimen contains one PPI, Colloidal Bismuth Pectin and two antibiotics based on personal medication history. If the patient has taken clarithromycin, roxithromycin and azithromycin for less than 2 weeks before, he will be treated with amoxicillin and clarithromycin. Otherwise, he will be treated with amoxicillin and furazolidone.
15910275|NCT03571230|Drug|one proton pump inhibitor(PPI)|All the patients need this drug.
15910276|NCT03571230|Drug|Colloidal Bismuth Pectin|All the patients treated with 14-day bismuth-based quadruple therapy need this drug.
15910277|NCT03571230|Drug|two antibiotics for failed eradication(tetracyclin,furazolidone)|If the patients failed with AST guided eradication therapy or empirical therapy, patients will be treated with another 14-day bismuth-based quadruple therapy. The regimen contains one PPI, Colloidal Bismuth Pectin, tetracycline and furazolidone.
15910330|NCT03570814|Drug|Administration of Albendazole on Day 1|Participants will receive Albendazole 400mg on study day 1.
15910331|NCT03570814|Drug|Administration of Ivermectin on Day 1|Participants will receive Ivermectin 150mcg/kg (max 12mg) on study day 1. Doses of Ivermectin will be determined using a standard dosing pole.
15910332|NCT03570814|Drug|Administration of Azithromycin on Day 1|Participants will receive Azithromycin 20mg/kg (max 1gm) on study day 1. Doses of Azithromycin will be determined using a standard dosing pole.
15910278|NCT03571204|Biological|3BNC117 and 10-1074|Both 3BNC117 and 10-1074 will be administered intravenously at 30 mg/kg dose level. Both study groups will receive 8 infusions of 3BNC117 and 10-1074 at weeks 0, 2, 4, 8, 12, 16, 20, and 24. The total duration of therapy is 24 weeks; the duration may be shorter if criteria listed in section 3.1 are met. The dose of both 3BNC117 and 10- 1074 for this study is 30 mg/kg in 250 ml normal saline. The two antibodies will be mixed in separate bags of saline for sequential administration. To prepare an IV infusion, the pharmacist will calculate the total milligrams of each antibody needed, thaw the minimum number of vials needed to obtain the full dose and add the calculated total milligrams needed to a final volume of 250 ml of normal saline using good pharmacy practices to maintain sterility. The infusion solution must be used within 3 hours. Any unused portion of an antibody vial will not be used for another subject.
15910279|NCT03571204|Biological|Normal saline placebo|8 infusions of placebo at weeks 0, 2, 4, 8, 12, 16, 20, and 24 will be administered. The total duration of therapy is 24 weeks; the duration may be shorter if criteria listed in section 3.1 are met. The placebo will be normal saline alone. The placebo will be in separate bags for sequential administration.
15910280|NCT03571191|Drug|Denosumab|Denosumab will be administered at 120 mg per dose every 4 weeks for six months, with loading doses on days 8 and 15 of month 1.
15910281|NCT03571178|Other|Physical Therapy|Physical therapy consisting of the application of hotpack, TENS and treatment ultrasound
15910282|NCT03571165|Behavioral|My Tools 4 Care - In Care|Self-administered web-based transition toolkit (My tools 4 Care - In Care) contains interactive activities and resources to help carers through transitions.
15910283|NCT03571152|Other|Educational videos|The level of practice and knowledge of the caregiver will be evaluated according to the video(s) corresponding to the session. Patient participation is expected for the evaluation of the caregiver's level of practice. After thirty minutes of use of the video, the level of practice and knowledge of the caregiver will be evaluated again for the same video. In each session this methodology will continue until the eighth video. At the end of all the videos, the level of satisfaction of the caregivers in relation to the videos will be evaluated.
15910284|NCT03571139|Device|Phacoemulsification|Cataract surgery and in the bag posterior chamber lens implantation
15910285|NCT03571126|Drug|Olanzapine|Dexamethasone (10mg/d) (Days1-3) Tropisetron (4mg or 4.48mg or 5mg /d) (Days1-3) Olanzapine (10mg/d) (Days1-4)
15910286|NCT03571126|Drug|Placebos|Dexamethasone (10mg/d) (Days1-3) Tropisetron (4mg or 4.48mg or 5mg /d) (Days1-3) Placebos (Days1-4)
15910287|NCT03571113|Other|Survival / not survival|Outcome with good neurological status vs. bad neurological status at hospital discharge
15910288|NCT03571100|Drug|Chlorhexidine|Chlorhexidine administration prior to intravitreal injection (compared to gold standard povidine-iodine)
15910289|NCT03571100|Drug|Povidine-Iodine|Povidine iodine administration prior to intravitreal injection (compared to chlorhexidine)
15910290|NCT03571087|Drug|HL140 5/10|"1) Treatment(W0~W8), Extension(W9~W20): 6Tab./q.d. HL140 5/10(Rosuvastatin5mg/Ezetimibe10mg) : ●♤♡□△◇
~●: HL140 5/10mg, ♤: HL140 10/10mg placebo, ♡: HL140 20/10mg placebo, □: Crestor Tab.5mg placebo, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo"
15910291|NCT03571087|Drug|HL140 10/10|"1) Treatment(W0~W8), Extension(W9~W20): 6Tab./q.d. HL140 10/10(Rosuvastatin10mg/Ezetimibe10mg) : ○♠♡□△◇
~○: HL140 5/10mg placebo, ♠: HL140 10/10mg, ♡: HL140 20/10mg placebo, □: Crestor Tab. 5mg placebo, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo"
15910292|NCT03571087|Drug|HL140 20/10|"1) Treatment(W0~W8), Extension(W9~W20): 6Tab./q.d. HL140 20/10(Rosuvastatin20mg/Ezetimibe10mg) : ○♤♥□△◇
~○: HL140 5/10mg placebo, ♤: HL140 10/10mg placebo, ♥: HL140 20/10mg, □: Crestor Tab. 5mg placebo, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo"
15910293|NCT03571087|Drug|Rosuvastatin 5mg → HL140 5/10|"Treatment(W0~W8): 6Tab./q.d. Rosuvastatin 5mg : ○♤♡■△◇
~○: HL140 5/10mg placebo, ♤: HL140 10/10mg placebo,♡: HL140 20/10mg placebo, ■: Crestor Tab. 5mg, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo
~Extension period(W9~W20): 6Tab./q.d. HL1405/10(Rosuvastatin5mg/Ezetimibe10mg) : ●♤♡□△◇
~HL140 5/10mg, ♤: HL140 10/10mg placebo, ♡: HL140 20/10mg placebo, □: Crestor Tab. 5mg placebo, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo"
15910294|NCT03571087|Drug|Rosuvastatin 10mg → HL140 10/10|"Treatment(W0~W8): 6Tab./q.d. Rosuvastatin 10mg : ○♤♡□▲◇
~○: HL140 5/10mg placebo, ♤: HL140 10/10mg placebo, ♡: HL140 20/10mg placebo, □: Crestor Tab. 5mg placebo, ▲: Crestor Tab. 10mg, ◇: Crestor Tab. 20mg placebo
~Extension period(W9~W20): 6Tab./q.d. HL140 10/10(Rosuvastatin10mg/Ezetimibe10mg) : ○♠♡□△◇
~HL140 5/10mg placebo, ♠: HL140 10/10mg, ♡: HL140 20/10mg placebo, □: Crestor Tab. 5mg placebo, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo"
15910295|NCT03571087|Drug|Rosuvastatin 20mg → HL140 20/10|"Treatment(W0~W8): 6Tab./q.d.Rosuvastatin 20mg : ○♤♡□△◆
~○: HL140 5/10mg placebo, ♤: HL140 10/10mg placebo, ♡: HL140 20/10mg placebo, □: Crestor Tab. 5mg placebo, △: Crestor Tab. 10mg placebo, ◆: Crestor Tab. 20mg
~Extension period(W9~W20): 6Tab./q.d. HL140 20/10(Rosuvastatin20mg/Ezetimibe10mg) : ○♤♥□△◇ ○: HL140 5/10mg placebo, ♤: HL140 10/10mg placebo, ♥: HL140 20/10mg, □: Crestor Tab. 5mg placebo, △: Crestor Tab. 10mg placebo, ◇: Crestor Tab. 20mg placebo"
15910296|NCT03571074|Other|Oxygenation|Oxygenation measured as oxygen supply and saturation before cardiac arrest, and oxygenation measured as PaO2 after cardiac arrest.
15910297|NCT03571061|Procedure|whole colon water immersion and sigmoid water immersion|we chose water immersion method instead of the triaditional method of carbon dioxide (CO2) insufflation.
15910298|NCT03571048|Behavioral|Reduced Calorie Diet (RCD)|Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD.
15910299|NCT03571048|Behavioral|Time Restricted Feeding (TRF)|Participants will be given an individualized calorie goal. Participants in this group will also receive a 12 week comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support RCD. Participants in this group will also instructed to eat only during a window of 10 hours, starting within 3 hours of waking. They will also be instructed in specific strategies to support TRF including: strategies to deal with hunger outside eating windows, distraction techniques, and choosing a balanced diet/appropriate portions during feeding windows.
15910333|NCT03570814|Drug|Administration of Azithromycin on Day 15|Participants will receive Azithromycin 20mg/kg (max 1gm) on study day 15. Doses of Azithromycin will be determined using a standard dosing pole.
15910300|NCT03571035|Diagnostic Test|Mandibular movements recordings by a mono vision system|To examine the mandible's movements, vision analysis was employed and performed with the digital camera which featured 1920 x 1080 resolution and was fixed on an aluminium extension arm attached to a headset worn by the subject.The camera was aligned parallel to the subject's face at a distance of 0.3 meters. The study used two 10 mm x 5 mm reference markers, which were accurately reproduced on the camera recorded images. In line, one marker was put on the medial cleft above the upper lip, and the other one was positioned below the first one in a straight line, in the middle of the chin. Then, the patient was asked to open maximally and close the mouth twice.To establish the mandible's trajectory, the line was drawn between the positions of the two markers to connect the two points. The line's parameters were calculated only during initial measurements and were constant throughout the study.
15910301|NCT03571022|Behavioral|USE-MI System|"Pilot Phase: 10 subjects will continue with their ART or PrEP medication and begin using the USE-MI system. Subjects will wear a smartwatch every day to monitor their pill taking activity for 1 month and receive weekly phone calls to obtain feedback on the system. During the first call, subjects will respond to 2 questionnaires about how they are taking their daily ART or PrEP pill(s).
~Second Phase: Up to 50 subjects will continue with their ART or PrEP medication and begin using the USE-MI system. Subjects will wear a smartwatch every day to monitor their pill taking activity for up to 6 months. During their first month, subjects will receive weekly phone calls to obtain feedback on the system. During the first call, subjects will respond to 2 questionnaires about how they are taking their daily ART or PrEP pill(s). Subjects will come to the research office every month to complete a brief questionnaire about how they are taking their daily ART or PrEP pill(s)."
15910302|NCT03571009|Device|utilization of PAAS|utilization of real-time pain assessment and analysis system (PAAS) consists of wearing device and reporting a real-time pain using the device
15910303|NCT03570996|Procedure|Esophagectomy|"Esophagectomy with minimally invasive approach of the chest including:
~3 hole with R video-assisted thoracoscopic surgery (VATS), Ivor Lewis R VATS, Transhiatal"
15910304|NCT03570996|Procedure|Transversus abdominis plane catheter|TAP group will have bilateral subcostal TAP catheters and single shot bilateral rectus sheath blocks placed at the end of the surgery, prior to emergence. Bilateral subcostal TAP catheters will be bolused with 20ml of .2% ropivacaine on each side and then infused with .2% ropivacaine at 10ml/ hr for 75 hours each. Rectus sheath blocks will be bilateral bolus 20ml of .2% ropivacaine
15910305|NCT03570996|Procedure|Epidural|Patients randomize the TEP group will have bilateral TEP placed at T8-9 +/- one level based on patient anatomy. TEP will be bolused with 5ml of 1.5% lidocaine with epinephrine and then started on infusion of .0625% bupivacaine plus 4 mcg/ml fentanyl plus 2 mcg/ ml epinephrine at 6ml/hr with a range of 6-12 ml/hr, titrating to optimize patient comfort. Epidurals are placed before surgery start time.
15910306|NCT03570983|Drug|Allopurinol|Dosage: Allopurinol 200 mg/m2/day starts on the day prior to BCNU, day -8 and stops on day -1.
15910307|NCT03570983|Drug|Carmustine|Dosage: Carmustine 300 mg/m2 IV x 1 will be infused over 3 hours on autografting day -7. Carmustine should not be infused with solutions or tubing containing or previously containing bicarbonate solution.
15910308|NCT03570983|Drug|Etoposide|Dosage: Etoposide 100 mg/m2 IV BID will be administered in 500-1000 cc normal saline over 2 hours on autografting days -6, -5, -4, and -3 for a total dose of 800 mg/m2. Etoposide may not be infused with sodium bicarbonate solutions.
15910309|NCT03570983|Drug|Cytarabine|Dosage: Cytarabine 100 mg/m2 IV BID will be infused over 3 hours on autografting days -6, -5, -4 and -3. Availability and administration: Cytarabine is available in a reconstituted form in solutions containing 20, 50 and 100 mg of cytarabine per mL.
15910310|NCT03570983|Drug|Melphalan|Melphalan will be administered at a dose of 200 mg/m2 IV x 1 infused over 30 minutes on autografting day -2.
15910311|NCT03570970|Drug|Banapenem|Banapenem to be used anti-infection
15910312|NCT03570957|Drug|MT-2990|MT-2990 solution for injection in vial
15910313|NCT03570957|Drug|Placebo|Placebo solution for injection in vial
15910314|NCT03570944|Procedure|HRS, KRS|Elective HRS or KNR in adult patients, with any ERAS compliance
15910315|NCT03570931|Drug|RT001|RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 960 mg of RT001.
15910317|NCT03570905|Other|Sugar Tong Splint|A splint made of 8-10 layers of plaster rolled into a single long sheet which begins at the distal volar crease of the hand and traverses around the elbow and stops at the dorsal metacarpal heads. The skin is protected with cotton cast padding (webril) and the splint is held in place with ace bandages
15910318|NCT03570905|Other|Clam Shell Splint|A 2-part splint made of 8-10 layers of plaster. The piece traverses from the distal volar crease of the hand to the volar aspect of the proximal forearm. The second piece runs along the dorsal aspect of forearm from metacarpal heads to proximal forearm. The elbow is left free. In the same fashion as the sugar tong splint, the skin is protected with cotton cast padding (webril) and held in place with ace wrap
15910321|NCT03570879|Device|Power morcellation|Power morcellation of surgical specimens after laparoscopic myomectomy.
15910322|NCT03570879|Procedure|Transvaginal extraction|Transvaginal extraction of surgical specimens after laparoscopic myomectomy.
15910323|NCT03570866|Diagnostic Test|Positron emission tomography and computed tomography|Preoperative staging of early stage intermediate and high-risk endometrial cancer with positron emission tomography and computed tomography.
15910324|NCT03570866|Procedure|Surgical treatment|Surgical treatment of early stage intermediate and high-risk endometrial cancer by usual practice: peritoneal cytology, total abdominal hysterectomy, bilateral salpingo-oophorectomy, systematic pelvic and para-aortic lymphadenectomy.
15910336|NCT03570775|Device|Sleeping bag phototherapy|This device has a LED light emitter that incorporates one fiber optic mesh and is protected by a vinyl cover and a disposable liner for patient comfort and hygiene. The phototherapy sleeping bag is conceived with the aim of increasing the surface of phototherapy by means of a double exposure: ventral and dorsal, which allows the insertion of two phototherapy devices of 20x30 centimeters. The ventral and dorsal caps incorporate mesh optical fibers that are connected to the light emitter, in which the phototherapy time can be programmed. The fiber optic meshes are protected by a vinyl cover and a disposable lining for patient comfort and hygiene.
15910337|NCT03570775|Device|Conventional phototherapy|This is a phototherapy device with six fluorescent tubes, four white and two blue, with adjustment of inclination and height incorporated. The device has a minimum height of 106 cm and a maximum of 152 cm, a depth of 64 cm and a width of 72 cm. The manufacturer recommends not using the lamp at distances of less than 50 cm because, although the heat radiation is minimal, this can influence distances less than 50 cm when the child is also exposed to infrared thermal radiation, typical of the servo cribs It is recommended to control temperature and eye protection due to the risk of ophthalmic injury from light, since the intensity of the light is concentrated in a single point.
15910338|NCT03570762|Procedure|hybrid percutaneous intervention|
15910339|NCT03570749|Drug|Baricitinib|Administered orally.
15910340|NCT03570749|Drug|Placebo|Administered orally.
15910341|NCT03570736|Procedure|Minimal invasive surgical technique|Minimal Invasive Surgical technique using either Modified Papilla Preservation or Simplified Papilla Preservation Technique.
15910342|NCT03570736|Procedure|Open Flap Debridement|Buccal and lingual intrasulcular incisions will be done extending at least one tooth mesial and distal to the tooth associated with the intrabony defect. Full thickness mucoperiosteal flaps will be reflected to allow access for debridement of the defect.
15910343|NCT03570723|Procedure|A glove-loaded Foley's catheter tamponade|A glove-loaded Foley's catheter tamponade, the internal os of the cervix was identified and a double-way 20 Fr Foley's catheter with a 30-50-ml balloon was inserted through the cervix to be handled by an assistant through the vagina and fixed to the patient's lower limb after inflation of the catheter balloon by 300 ml warm saline and pulling it against the lower uterine segment between the two transverse sutures. Only one glove-loaded Foley's catheter was used for tamponade.
15910344|NCT03570723|Procedure|stepwise uterine devascularization|"Uterine hemostatic sutures, through examination of the placental bed, may use some hemostasis at the placental bed,overswing was commenced using endo-uterine sutures. If there is still significant bleeding, bilateral uterine artery ligation, and internal iliac artery ligation when needed.BUAL started immediately through blunt dissection downwards and laterally of the peritoneum covering the uterine isthmus and cervix. The peritoneum is mobilized freely at the uterine angles to expose both uterine arteries and avoid inclusion of the ureters in the ligation. The uterine artery pulsations were palpated digitally at the level of the internal os."
15910345|NCT03570710|Drug|intravenous tranexamic acid|1 gm tranexamic acid (2 ampoules of Capron 500 mg /5 ml; Amoun, Cairo, Egypt) intravenous just before skin incision plus110 ml normal saline IV just before skin incision plus topical application of 200 ml normal saline applied on the pelvic bed after Cesarean hysterectomy
15910346|NCT03570710|Drug|Topical tranexamic acid|2 gm topical tranexamic acid ( 4 ampoules of Capron 500 mg/5 ml applied typically) in 200 ml normal saline applied on the pelvic bed after Cesarean hysterectomy plus110 ml normal saline IV just before skin incision plus topical application of 200 ml normal saline applied on the pelvic bed after Cesarean hysterectomy plus In topical tranexamic acid group gauze soaked with 2g tranexamic acid (20 ml) diluted in 200 ml of sodium chloride 0.9% or placebo (120ml of sodium chloride 0.9%.) applied on the pelvic bed after Cesarean hysterectomy. To ensure a sufficiently high concentration, the tranexamic acid was diluted only to a volume sufficient to moisten a large wound surface. 20 ml moisten at least 1500 cm2.
15910347|NCT03570710|Drug|Normal saline|110 ml normal saline IV just before skin incision plus topical application of 200 ml normal saline applied on the pelvic bed after Cesarean hysterectomy
15910348|NCT03570697|Biological|Evolocumab|Subjects will receive Evolocumab (AMG 145) subcutaneous monthly.
15910349|NCT03570697|Other|Placebo|Subjects will receive Evolocumab (AMG 145) matching placebo subcutaneous monthly.
15910350|NCT03570684|Device|Cable Tie|During the operation, after mobilization the rectum, the disinfected Cable Tie was introduced into the pelvic cavity.then the rectum was bundled by the tie which was easy as the tie is auto-locked. pulling the tie and the rectum would be explored clearly, and then the endoscopic linear cutter was introduced to transect the rectum. the tie made the rectum folded not applanate, that the cutter was able to transect the rectum easily and with less reloader. when the rectum was resected completely, the tie was get out with the specimen, and do not live in the abdomen.
15910351|NCT03570671|Diagnostic Test|Spasm positive|"Investigators define the positive criteria for VSA on MDCTA as follows:
~Significant stenosis (≥ 50%) with negative remodeling but no definite evidence of plaques, which completely dilated on IV nitrate CT, or
~Diffuse small diameter (< 2mm) of a major coronary artery with beaded appearance which completely dilated on IV nitrate CT."
15910352|NCT03570671|Diagnostic Test|Spasm negative|Suspected vasospastic angina subjects with negative MDCTA-derived VSA are considered as reference modality.
15910353|NCT03570658|Drug|RO7049389|RO7049389 will be administered orally either as a single dose (SAD) or as multiple doses defined by the SAD portion of the study (MAD).
15910354|NCT03570658|Drug|Placebo|Placebo will be administered orally at a dose and frequency matched to RO7049389.
15910355|NCT03570645|Drug|Dexmedetomidine Group|combination of ropivacaine and dexmedetomidine 100 ug every time
15910356|NCT03570645|Drug|dexamethasone group|combination of ropivacaine and dexamethasone 10mg every time
15910357|NCT03570645|Drug|control group|block with only ropivacaine
15910358|NCT03570632|Drug|Metformin|Participants randomized to metformin will receive metformin in addition to standard treatment of diabetes during pregnancy
15910359|NCT03570619|Drug|Nivolumab|All patients will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 52 weeks of total therapy.
15910427|NCT03570073|Other|Manual vitrification|Two oocytes will be frozen by vitrification. At thawing, the degree of rehydration objectified by the measurement of oocyte surfaces and the appearance of potential lysis will be studied thanks to culture in the embryoscope.
15910360|NCT03570619|Drug|Ipilimumab|All patients will begin receiving combination therapy with nivolumab 3 mg/kg IV and ipilimumab 1 mg/kg IV every 3 weeks for up to 4 cycles if tolerated, followed by nivolumab maintenance therapy at flat dose 480 mg IV every 4 weeks through the end of the planned study duration, for up to 52 weeks of total therapy.
15910361|NCT03570606|Device|bone graft substitute|orthopaedic or spine bony defects
15910362|NCT03570593|Procedure|REMOVAL OF URINARY CATHETER AFTER RADICAL SURGERY|Removal of urinary catheter on the first day after radical surgery
15910363|NCT03570580|Other|OSA scoring|OSA scoring (four scores: STOP-Bang, P-SAP, OSA50, DES-OSA were performed by several scorers on each patients, after what agreement between scores will be evaluated).
15910364|NCT03570567|Device|Piranha Treatment|The piranha device is used with an endoscope to breakup/dislodge the food bolus.
15910365|NCT03570554|Drug|Naproxen Sodium (Aleve, BAY117031)|660 mg daily for 3 days, 440 mg on the fourth day, over-encapsulated tablet, oral (Treatment A)
15910366|NCT03570554|Drug|Acetaminophen ER|3900 mg daily for 3 days, 1300 mg on the fourth day, over-encapsulated extended release (ER) tablet, oral (Treatment B)
15910367|NCT03570554|Drug|Celecoxib|200 mg daily for 3 days, 100 mg on the fourth day, over-encapsulated capsule, oral (Treatment C)
15910368|NCT03570554|Drug|Placebo|Over-encapsulation capsule, 4 days, oral (Treatment D)
15910369|NCT03570541|Drug|Ropivacaine|30 mL ropivacaine 0,375% administered on each side as bilateral TQL blocks
15910370|NCT03570541|Drug|Acetaminophen|Every six hours postoperative, all patients are administered 1 g of acetaminophen.
15910371|NCT03570541|Device|Patient controlled analgesia|PCA-pump with IV-Morphine. 5 mg administered per bolus. Lock-out time and max. dosage standardized.
15910372|NCT03570541|Drug|Morphine|intravenously administered morphine via PCA-pump
15910373|NCT03570541|Drug|Saline|30 ml saline 0,375% administered on each side as bilateral TQL blocks
15910374|NCT03570541|Diagnostic Test|Blood samples|On the day of surgery, postop day 1+2 and day 10-14, all patients will have blood samples taken for immunological analysis
15910375|NCT03570541|Behavioral|Quality of recovery-15 questionaire|On the day of surgery, postop day 1+2 and day 10-14, all patients are asked to fill out a short questionaire.
15910376|NCT03570541|Diagnostic Test|Orthostatic hypotension|Before surgery, and 3, 6 and 24 hours postop. All patients are tested for orthostatic hypotension.
15910377|NCT03570515|Behavioral|Yoga|Yoga group participants will attend two, 75-minute yoga classes/week for 4 weeks, then one class/week for 8 weeks, and do a 30-minute home practice on non-class days, recording their practice on a yoga homework log provided to them.
15910378|NCT03570515|Behavioral|Educational film|Educational film group participants will attend one, 75-minute film class/week for 12 weeks, recording any RLS treatments they use at home.
15910379|NCT03570489|Behavioral|Exercise|Patients will bicycle for 20 minutes per day for 5 days per week for 6 months
15910380|NCT03570489|Behavioral|Relaxation|Patients will listen to a relaxation tape 20 minutes per day 5 Days a week for 6 months
15910381|NCT03570476|Drug|Olaparib|Given orally
15910382|NCT03570476|Procedure|Radical Prostatectomy|Undergo surgery
15910383|NCT03570463|Behavioral|GLA:D Back|The intervention aims at improving the participant's ability to self-manage low back pain (LBP). The content is based on a cognitive behavioural approach aimed at supporting pain self-efficacy. An individual session at the beginning and the end of the group sessions involve goal-setting and physical tests. Key messages of the patient education include that pain is not a sign of danger and back pain is explained using a behavioural model of (im)balance between demands and capacity rather than emphasising tissue damage. The exercises aim at restoring natural variation in movement and provides guidance for patients in exploring movement rather than teaching exercises in only one correct manner.
15910384|NCT03570450|Drug|Adipose derived Stem Cell|3 doses
15910385|NCT03570450|Drug|placebo|placebo
15910386|NCT03570437|Drug|Paclitaxel|80 mg/m2 on three days in a 28 day cycle (with 6 cycles)
15910387|NCT03570437|Drug|Cediranib|20 mg per day
15910388|NCT03570437|Drug|Olaparib|Olaparib tablets, 300 mg twice-daily
15910389|NCT03570424|Dietary Supplement|Nutrient support to HIIT|3 groups of young (aged 18-35 y), healthy, recreationally active, aerobically untrained (VO2max <50 ml.kg.min-1) males will undertake 3 weeks (9 sessions) of HIIT under different nutrient conditions following >10h overnight fast: i) Placebo: Fasted artificially flavoured and textured placebo 45 minutes prior to exercise; ii) Whey protein 45 minutes prior to exercise; iii) Whey protein hydrolysate 45 minutes prior to exercise).
15910390|NCT03570424|Dietary Supplement|Placebo|3 groups of young (aged 18-35 y), healthy, recreationally active, aerobically untrained (VO2max <50 ml.kg.min-1) males will undertake 3 weeks (9 sessions) of HIIT under different nutrient conditions following >10h overnight fast: i) Fasted artificially flavoured and textured placebo 45 minutes prior to exercise; ii) Fed Whey protein 45 minutes prior to exercise; iii) Fed Whey protein hydrolysate 45 minutes prior to exercise).
15910391|NCT03570411|Diagnostic Test|T-SPOT®.CMV Test|The T-SPOT.CMV test (Oxford Diagnostic Laboratories) measures the strength of T cell responses to CMV specific antigens. Using whole blood samples obtained through a standard blood collection tube, white blood cells (WBC's) are separated and purified. The cells are quantified and placed into specially designed plates where they are challenged with antigens specific to the disease under study. Disease-specific cells responding to these antigens will release immune messenger molecules, called cytokines. We then use chemistry to allow us to visualize those WBCs releasing cytokines (and hence those which react to the antigen), resulting in a spot on the bottom of the plate, corresponding to the footprint of an individual reacting WBC. Finally, we use an automated image analysis system to identify and count each of these spots to give a quantitative readout. That quantitative readout gives us the frequency of responsive disease-specific cells (Oxford Immunotec, 2017).
15910392|NCT03570398|Other|unenhanced abdomino-pelvic CT scan|unenhanced abdomino-pelvic CT scan
15910393|NCT03570398|Other|abdominal ultrasound|abdominal ultrasound
15910394|NCT03570385|Device|MRI|MRI in diffusion tensor (DTI : Diffusion Tensor Imaging)
15910395|NCT03570372|Behavioral|Internet-based treatment for adults with autism spectrum|Internet-based CBT. The intervention includes 36 modules focusing on: Psychoeducation, individual goal setting, behavioral change, management strategies, mindfulness techniques, stress management, sleep techniques, information about societal rights.
15910490|NCT03569540|Other|Placebo|Amylum
15910396|NCT03570372|Behavioral|Psychoeducation about autism spectum disorder|"Self-studies by reading the book What does the disability mean ?: Living with autism / Asperger syndrome. Project Empowerment (2004), by Norrö & Swing Åström, as well as a book of biographical stories of people who have ASD. The first book will be read during the first half of the project, and the second will be in the second half."
15910397|NCT03570359|Drug|Interferon Beta-1A|Interferon Beta-1A via inhalation
15910398|NCT03570359|Other|Placebo|Placebo via inhalation
15910399|NCT03570346|Drug|Hemay005|Subjects will be randomized into 3 dose groups orally twice daily.
15910400|NCT03570346|Drug|Placebo|Subjects will be randomized into 3 dose groups orally twice daily.
15910401|NCT03570333|Diagnostic Test|progenitor potential of Gingival Mesenchymal cells|tissues collected from the molar and premolar sites will be sent to the lab for cell culturing. once in the lab, the tissues will be already separated and labeled (molar) and ( premolar) and then treated to extract the cells from them. then, these cells will be tested for their capacity to form different kinds of cells and tissues ( bone, cartilage, fibers for periodontal ligaments). After this test, results will be collected for how many cells were collected from each tissue sample.
15910402|NCT03570320|Other|Modification of opioid prescription method|Patients in the interventional arm of the study will receive post-op opioid medications in three small prescriptions as opposed to one large prescription. They may fill these prescriptions as needed.
15910403|NCT03570307|Other|medical VS surgical evacuation of the uterus|mentioned above
15910404|NCT03570294|Drug|Atosiban|The initial dose of Atosiban (Tractocile, Ferring Pharmaceuticals A/S, Copenhagen, Denmark) will be give as a single intravenous bolus dose (6.75 mg in 0.9 ml isotonic sodium chloride solution). This will be follow immediately by intravenous infusion of 300 μg/min of Atosiban in 5% glucose for 3 hours, and then 100 μg/min for up to 48 hours. Venous blood samples from a forearm vein will take before and after 48 hours of continuous administration tocolytic therapy with Atosiban.
15910405|NCT03570281|Drug|Edoxaban|Edoxaban, per oral, 60mg qd (may consider reduced dose to 30mg qd in patients with proper clinical reason by attending physician, estimated creatinine clearance of 30 to 50 ml per minute, a body weight of 60 kg or less, or the concomitant use of verapamil or quinidine), for 90 days.
15910406|NCT03570281|Drug|Enoxaparin|Enoxaparin, subcutaneous injection, 1mg/kg BID (may consider reduced dose to 1mg/kg qd in patients with proper clinical reason by attending physician, Creatinine clearance <30 mL/min), for 90 days.
15910407|NCT03570268|Other|Experimental Group: Education|Participants in the experimental intervention group received an educational program and tailored home exercises.
15910408|NCT03570268|Other|Control Group: Usual care|Participants allocated to the control group received stretching exercises.
15910409|NCT03570255|Device|RD SET Neo SpO2|All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor.
15910410|NCT03570242|Other|Whole-Body Electromyostimulation (WB-EMS)|WB-EMS training is performed 2x/week for 12 weeks; Stimulation protocol: Frequency of 85 Hz, pulse duration of 0.35 ms, stimulation period of 6 sec, resting period of 4 sec; supervised by certified training instructors/physiotherapists participants perform simple exercises during the stimulation period following a video tutorial
15910411|NCT03570229|Other|Hyperbaric oxygen treatment|"Participants in this study will receive hyperbaric oxygen treatment (HBOT) but the investigators do not assign this specific intervention to the study participants. Thus, the patients in this study will receive HBOT as part of routine medical care. Consequently, we regard this as an observational study because the patients will get HBOT independently of the study and they are NOT assigned prospectively to HBOT according to a protocol to evaluate the effects.
~HBOT for pelvic radiation injury typically involves a treatment pressure of 2.4 ATA (Atmospheres Absolute) breathing oxygen for 90 minutes. The treatment is delivered as series treatment, usually daily treatment up to 30 dives."
15910412|NCT03570216|Other|Cardiopulmonary exercise test|Participants will perform a graded cardiopulmonary exercise test to asses their cardiorespiratory fitness. It will also provide a peak exercise stimulus to examine acute changes in arterial stiffness, and to prescribe both moderate intensity continuous exercise and high intensity interval exercise.
15910413|NCT03570216|Other|Moderate-intensity continuous exercise|Participants will perform a 30-minute session of moderate-intensity continuous exercise.
15910414|NCT03570216|Other|High-intensity interval exercise|1 week later, participants will perform a 19-minute session of high-intensity interval exercise.
15910415|NCT03570203|Diagnostic Test|Serum Sodium|Measurement of serum sodium.
15910416|NCT03570190|Other|Coordinator|"A THV coordinator will be responsible for communication with the patients and the caregivers as well as for monitoring medical documentation and treatment pathways. The registry will consist of 3 phases:
~Determination of the status quo
~Dedicated reflection and training followed by implementation of tailored changes
~Determination of the effect"
15910417|NCT03570164|Drug|Sevoflurane|End-tidal concentration of sevoflurane is maintained at age-corrected 1.0 minimum alveolar concentration throughout the study period.
15910418|NCT03570164|Drug|Desflurane|End-tidal concentration of desflurane is maintained at age-corrected 1.0 minimum alveolar concentration throughout the study period.
15910419|NCT03570151|Other|no intervention|no intervention will be done
15910420|NCT03570138|Device|FREESTYLE LIBRE device, a Flash Continuous Glucose Monitoring System|Specific therapeutic education for diabetes self management
15910421|NCT03570138|Device|Usual self monitoring Blood Glucose device|Standard therapeutic education for diabetes self management
15910422|NCT03570125|Dietary Supplement|Prolon|The diet consists of natural ingredients, which are Generally Regarded As Safe (GRAS). In case the PROLON product will be unavailable at the time of the project we will design fasting mimicking diet without the usage of specifically designed commercial product
15910423|NCT03570112|Drug|SOF/VEL- sofosbuvir 400mg and velpatasvir 100mg|sofosbuvir 400mg and velpatasvir 100mg once daily for 12 weeks
15910424|NCT03570099|Drug|Naloxone Nasal Spray|Naloxone Nasal Spray will be distributed at the addiction centres.
15910425|NCT03570099|Other|Historical control cohort|Historical data will be retrieved from quality registries.
15910426|NCT03570086|Diagnostic Test|diagnostic|using radiomics features from multiparametric thick-section clinical-quality brain MRI to distinguish migraineurs from health controls.
15910523|NCT03569332|Other|Nurse's dashboard|"Wireless data transmission system
~The practicing rate of participants on study group is sent to Nurse's Dashboard.
~It is only to display."
15910428|NCT03570073|Other|Vitrification with GaviTM system|Two oocytes will be frozen by vitrification. At thawing, the degree of rehydration objectified by the measurement of oocyte surfaces and the appearance of potential lysis will be studied thanks to culture in the embryoscope.
15910429|NCT03570060|Biological|Blood sample|2 ml of blood for testing for serum biomarkers (IL-6, GDF-15, soluble ST-2 soluble, osteoprotegerin, galectin 3)
15910430|NCT03570060|Procedure|Long term ECG monitor|Fitting and removal of a long term ECG monitor (SpiderFlash, LivaNova)
15910431|NCT03570060|Procedure|Monitoring ECG|Recording of automatic ECG monitor results (CSM Philips IntelliVue MP50 system)
15910432|NCT03570034|Device|Obalon Balloon System|Obalon Balloon System with a moderate intensity Weight Loss Behavioral Modification Program
15910433|NCT03570021|Procedure|total thyroidectomy with bilateral prophylactic central compartment (level VI) neck dissection|"total thyroidectomy with bilateral prophylactic central compartment (level VI) neck dissection as defined by the American Thyroid Association [American Thyroid Association Surgery Working Group, Thyroid 2009]. This is a standard treatment recognized by the French Society of Otolaryngology Head and Neck Surgery [French Society of Otolaryngology Head and Neck Sugery].
~- The number of lymph nodes resected, the number of metastatic nodes, their size and the presence or absence of extranodal spread will be recorded. Due to the large natural variability of the number of lymph nodes retrieved in a prophylactic neck dissection [Hartl DM, Ann Surg 2012], no patient will be excluded on the basis of number of lymph nodes. Furthermore, the participating surgeons routinely perform complete central neck dissections, and were chosen to participate in this study due to a homogenous technique among these surgeons [Hartl DM, World J Surg 2012]."
15910434|NCT03570021|Procedure|total thyroidectomy alone without neck dissection|This is recognized as a standard treatment by the Francophone Association of Endocrine Surgery
15910435|NCT03570008|Behavioral|9 days spa residential program|"After the inclusion visit, the participants will be involved in a short-term spa residential program of 9 days (Sp). The will be randomized into 3 groups of 30 participants:
~Sp-Ex: spa residential program including physical activity
~Sp-alone: spa residential program alone
~Ex-alone: physical activity alone
~After the spa residential program, participants will undergo a one-year at-home follow-up. The participants will be required to complete the same program by themselves.
~A journal and an accelerometer-pedometer watch will record the weekly physical activity performed. Monitoring will be further monthly assessed by a health-care professional from the spa resorts."
15910436|NCT03570008|Behavioral|3 sessions of 10 minutes per day of physical exercise|"After the inclusion visit, the participants will be involved in a short-term spa residential program of 9 days (Sp). The will be randomized into 3 groups of 30 participants:
~Sp-Ex: spa residential program including physical activity
~Sp-alone: spa residential program alone
~Ex-alone: physical activity alone
~After the spa residential program, participants will undergo a one-year at-home follow-up. The participants will be required to complete the same program by themselves.
~A journal and an accelerometer-pedometer watch will record the weekly physical activity performed. Monitoring will be further monthly assessed by a health-care professional from the spa resorts."
15910437|NCT03569995|Drug|Rituximab|500 mg/m2 + 5%DW 500 mL IVF Begin with 50 mg/hr (increase by 50 mg/hr per 30 min until 400 mg/hr is reached)
15910438|NCT03569995|Drug|Methotrexate|500 mg/m2 + 5%DW 200 mL IV over 15 minutes 3000 mg/m2 + 5%DW 500 mL IVF over 3 hrs Concurrent hydration and subsequent leucovorin rescue is mandatory
15910439|NCT03569995|Drug|Cytarabine Injection|3000 mg/m2 + 5%DW 200 mL IVF over 2 hrs steroid eye drop 0.1%, 2 drops q 6hrs, on days 1-9
15910440|NCT03569982|Other|Integrative medicine care|Including acupuncture, relaxation/breathing, and manual/touch modalities
15910441|NCT03569969|Procedure|device: Tympanoplasty with Membrane Amniotic|amniotic membrane Tympanoplasty
15910442|NCT03569969|Procedure|Tympanoplasty With Autologous Fascia|Autologous Temporalis fascia Tympanoplasty
15910443|NCT03569956|Other|556 Razor|In the Razor group, subjects will use the 556 Razor with their regular shaving products, and shave at least 5 or more times per week. In the Regimen group, subjects will use the 556 Razor, Pre-Shave Gel, Cleansing brush and Shaving Gel, and shave at least 5 or more times per week. All subjects will be given the 556 Razors during the 12-week study. The Regimen group will also be given the Pre-Shave Gel, Cleansing Brush, and Shaving Gel.
15910444|NCT03569943|Device|Robot Based Transtympanic drain placement|Placement of a transtympanic drain with a robot based device assistance called RobOtol
15910445|NCT03569930|Drug|flavonoid-based supplements|Ingredients: soybean oil (glycine max), edible gelatin, rutin, borage seed oil (borago officinalis), pineapple dry extract (ananas sativus), glycerol, thickeners (mono and diglycerides of fatty acids), emulsifier (soy lecithin).
15910446|NCT03569930|Drug|Centella Complex|The components are: Centella Asiatica, Beta-glucan, Arnica, Aloe Vera, Menthol, Devil's claw, perform actions useful to alleviate the painful symptomatology, restore the tone of the venous wall, assist the treatment of microcirculatory damage.
15910447|NCT03569930|Behavioral|standard of care|diet rich in water and vegetable fibers, hygienic and anal dilator
15910448|NCT03569917|Other|Rectal swab collection|Rectab swab collection will be performed at inclusion and 5 and 30 days later.
15910449|NCT03569891|Genetic|AAV5-hFIXco-Padua|Single intravenous infusion of AAV5-hFIXco-Padua (AMT-061)
15910450|NCT03569878|Behavioral|Peer-Integrated Multidisciplinary Collaborative Care|Case management, behavioral intervention elements, psychopharmacologic medication recommendations and 24/7 cell phone coverage for 6 months post-injury.
15910451|NCT03569878|Behavioral|Trauma surgery team notification|Trauma surgery team notification of patient emotional distress, with plan for mental health inpatient consultation will be the comparator condition.
15910452|NCT03569865|Device|Audiovisual Stimulation|A commercially available AVS device (MindPlace Procyon) modified for use in the current study will be used to deliver the AVS programs in this study.
15910453|NCT03569852|Behavioral|Time Restrictive Feeding|Volunteers will adhere to a form of time restrictive feeding, 16 hours fasting and 8 hours eating per day.
15910454|NCT03569852|Behavioral|Traditional Eating Pattern|Volunteers will adhere to a more traditional eating pattern, 12 hours fasted and 12 hours eating per day.
15910455|NCT03569839|Drug|Propofol|Patients undergoing surgery, TIVA (total intravenous anaesthesia)
15910456|NCT03569826|Other|Observational; no intervention|Observational; no intervention
15910457|NCT03569813|Behavioral|PrEP@Home System|"The PrEP@Home system includes a home care kit mailed quarterly to participants. The kit includes components for self-collection of urine, rectal swab, pharyngeal swab and microtube blood collection, and materials for return shipping. Biological tests routinely performed at PrEP follow-up visits will be conducted on the specimens. At months 6 and 12, the kit will include materials to assess for protective levels of TFV-DP.
~The system includes a study app through which participants may track the mailing of home testing kits, access quarterly surveys, and communicate with study clinicians. The surveys will include domains that physicians assess at PrEP care quarterly follow-up visits (sexual risk, illicit substance use, PrEP adherence, side effects).
~Lab and survey results will be sent to study clinicians and if the results show no contraindications for PrEP continuation, the clinician may renew a participant's PrEP prescription. Telemedicine visits will be scheduled as necessary."
15910458|NCT03569813|Other|Standard of Care|Control participants will receive clinic-based PrEP follow-up. After the baseline assessment, control participants will receive active linkage to standard, clinic-based PrEP care for their next PrEP care follow-up visit. Participants will also download the control version of the study app, which will contain only research elements pertinent to their participation in the control arm of the study including quarterly surveys. At months 6 and 12, control arm participants will be sent materials for DBS self-collection and return shipping to allow for measurement of the study outcome, TFV-DP levels.
15910459|NCT03569800|Other|self completed questionnaire|self completed questionnaire
15910460|NCT03569787|Diagnostic Test|MRI Pituitary|Identification of whether of not patients had had an MRI pituitary following hyperprolactinaemia reading
15910461|NCT03569774|Procedure|One-lung ventilation with individualized PEEP|During one-lung ventilation for lung resection surgery, PEEP will be applied. After a subject's individualized PEEP (PEEP that corresponds to maximum lung compliance) is determined, the subject will receive one-lung ventilation with individualized PEEP.
15910462|NCT03569774|Procedure|One-lung ventilation with low PEEP|Subjects will receive one-lung ventilation with low PEEP (5 cmH2O)
15910463|NCT03569761|Behavioral|Colorectal Cancer Screening Decision Aid|Information previously discussed in arm/group descriptions. There will be baseline, post-encounter, and 5-month follow-up assessments.
15910464|NCT03569761|Behavioral|Control Group|Information previously discussed in arm/group descriptions. There will be baseline, post-encounter, and 5-month follow-up assessments. Information previously discussed in arm/group descriptions. There will be baseline, post-encounter, and 5-month follow-up assessments.
15910465|NCT03569748|Device|IQOS|IQOS USE FOR 12 WEEKS
15910466|NCT03569748|Device|E-CIG|ELECTRONIC CIGARETTE FOR 12 WEEKS
15910467|NCT03569709|Behavioral|Aerobic Exercise|Progressive sub-threshold aerobic exercise
15910468|NCT03569709|Behavioral|Rest|No structured exercise.
15910469|NCT03569709|Behavioral|Stretching|Gentle progressive upper and lower extremity stretching program
15910470|NCT03569696|Biological|nivolumab|The treatment phase will begin 10 ± 2 weeks from completion of R- anthracycline based therapy. Cycle 1 day 1 will occur within 72 hours from enrolment. Study treatment will be continued until nivolumab discontinuation due to disease progression, unacceptable toxicity or completion of 2 years or 30 doses of therapy. Study drug nivolumab will be administered intravenously every 2 weeks as described in the investigator brochure (IB) in a dose of 240mg over 30 minutes 46 for 8 cycles and then 480mg every 4 weeks for two years (cycle 9-30)to a maximum of 30 doses whichever comes first.
15910471|NCT03569683|Procedure|External bevel gingivectomy|External bevel gingivectomy will be performed on 30 patients wherein the suprabony pockets will be eliminated with the help of a Bard parker blade no 15. The incision would be given 1mm apical to the pockets which would be marked by a Crane and Kaplan pocket marker, then the incision would be given and the tissue would be removed with the help of kirkland and orbans knives and the gingiva would be shaped. After the surgical procedure the patients would be treated either with the Diode laser(Group A), Hyaluronic acid gel (Group B), or Herbal gel(Group C).
15910472|NCT03569683|Device|Diode laser Biostimulation|After gingivectomy, laser irradiation will be done using bio-stimulation tip in the anterior sextants of the mouth. (Group A)
15910473|NCT03569683|Other|Hyaluronic acid (Gengigel) topical application.|After gingivectomy, Hyaluronic acid gel(Gengigel) will be applied topically. Then it will be covered with a tin foil and periodontal dressing would be given. (Group B)
15910474|NCT03569683|Other|Herbal gel (Hiora SG) topical application|After gingivectomy, Herbal gel(Hiora SG) will be applied topically. Then it will be covered with a tin foil and periodontal dressing would be given. (Group C)
15910475|NCT03569670|Device|Posterior stabilized all-polyethylene tibial component|Patients randomized to this arm will have a Triathlon implant with a posterior stabilized, all-polyethylene tibial component used during surgery.
15910476|NCT03569670|Device|Cruciate retaining all-polyethylene tibial component|Patients randomized to this arm will have a Triathlon implant with a cruciate retaining, all-polyethylene tibial component used during surgery.
15910477|NCT03569657|Behavioral|A positive psychology workshop|Group workshop
15910478|NCT03569644|Other|qualitative study|Interviews
15910479|NCT03569631|Drug|BPN14770|25 mg BPN14770 capsules
15910480|NCT03569631|Drug|Placebo|Placebo capsules to mimic 25 mg BPN14770 capsules
15910481|NCT03569618|Device|Tablet-based Game|Tablet-based game aimed at improving processing speed and attention.
15910482|NCT03569605|Behavioral|Self-help|Participants will receive an individual session, Fitbit activity tracker, and access to a secret Facebook group.
15910483|NCT03569605|Behavioral|Intervention|Participants will receive an individual session, Fitbit activity tracker, and access to a secret Facebook group with the addition of behavioral lessons, adaptive physical activity goals, tailored feedback summaries, and text messages.
15910484|NCT03569592|Behavioral|Overdose Prevention Intervention|Evaluate an overdose prevention education with incarcerated people living with HIV/AIDS.
15910485|NCT03569579|Drug|Memantine Tab. 10mg|Memantine Tab. 10mg* 2T/day, QD, PO
15910486|NCT03569579|Drug|Memantine Tab. 10mg + Donepezil Tab. 10mg|Memantine Tab. 10mg* 2T/day + Donepezil Tab. 10mg * 1T/day, QD, PO
15910487|NCT03569566|Other|Age, Genes, Training, Tickbourne Disease and Endurance|Testing of genes, exosomes, physiological variables, tick-bourne disease markers, observation of training modality and performance
15910488|NCT03569553|Drug|AIGIV|Anthrax Immune Globulin Intravenous (Human)
15910489|NCT03569540|Drug|Glibenclamide|Placebo-controlled; Double blind test
15910491|NCT03569527|Dietary Supplement|Kiwifruit|The total duration of the study will be 8 weeks (2- week baseline, 4-week intervention, and 2-week follow-up). Eligible patients will be randomized to receive kiwifruit (2 green kiwifruit per day for the 4 week intervention period.
15910492|NCT03569527|Dietary Supplement|Fiber|The total duration of the study will be 8 weeks (2- week baseline, 4-week intervention, and 2-week follow-up). Eligible patients will be randomized to receive psyllium fiber (24 g/day, fiber=6g/day) for the 4 week intervention period.
15910493|NCT03569527|Dietary Supplement|Prunes|The total duration of the study will be 8 weeks (2- week baseline, 4-week intervention, and 2-week follow-up). Eligible patients will be randomized to receive prunes/dried plums (100g, fiber=6 g/day) for the 4 week intervention period.
15910494|NCT03569514|Drug|AIGIV|Anthrax Immune Globulin Intravenous (Human)
15910495|NCT03569501|Dietary Supplement|DHA|500 mg DHA tablets
15910496|NCT03569501|Dietary Supplement|oat grains|90 mg oat, containing 4.05 mg β-glucan
15910497|NCT03569488|Diagnostic Test|FT-LARS questionnaire|FT-LARS questionnaire
15910498|NCT03569475|Drug|Levomilnacipran ER|During the double-blind treatment period, patients will take levomilnacipran 10 mg/day on Days 1-3, 20 mg/day on Days 4-7, and 40 mg/day during Weeks 2 through 8. Based on therapeutic response and tolerability, an additional dose increase to 80 mg/day is permitted at Week 3. During the down-taper period, patients will take levomilnacipran 40 mg/day for 2 days, and then levomilnacipran 20 mg/day for 5 days
15910499|NCT03569475|Drug|Fluoxetine|During the double-blind treatment period, patients will take Fluoxetine 10 mg/day on Days 1-7, and then 20 mg/day during Weeks 2 through Week 8. During the down-taper period, patients will take Fluoxetine 10 mg/day for 7 days.
15910500|NCT03569475|Drug|Placebo|Patients randomized to the placebo arm will take placebo capsules once daily
15910501|NCT03569462|Behavioral|"Mobile WeChat intervention"|Participants watch a demonstration of HIV self-testing, receive HIV self-testing kits, and receive access to a mobile application that delivers content to promote HIV self-testing and reduce HIV risk behavior
15910502|NCT03569462|Behavioral|Control condition|Participants watch a demonstration of HIV self-testing and receive HIV self-testing kits.
15910503|NCT03569449|Behavioral|Usual care|Family partners will keep records and communicate with families using standard information technology, including telephones, electronic medical records, and standard desktop software.
15910504|NCT03569449|Behavioral|Clinic-based visits|Family partners will be restricted to working at the primary care clinic - communication will be restricted to telephone, text, and clinic visits
15910505|NCT03569449|Behavioral|Standard pediatric surveillance|Monitoring is determined by standard pediatric practice. Behavioral screening is usually done annually.
15910506|NCT03569449|Behavioral|Structured, schedule-based visits|Family Partners will utilize a predetermined schedule of contacts with families
15910507|NCT03569449|Behavioral|Enhanced pediatric surveillance|"In Massachusetts, behavioral screening is mandated at every pediatric visit, which for children in the target population (ages 3-12 years) is annually. With enhanced monitoring, Family Partners will screen children using validated instruments quarterly and communicate results to the child's care team"
15910508|NCT03569449|Behavioral|Technology enhanced care coordination|Behavioral: technology enhanced care coordination FPs will also have access to Act.MD, a cloud-based care coordination and communication tool that offers the potential to improve communication with families, schools, and the primary care site through administration of online questions, videoconferencing, and common portals that can be used by parents and multiple providers (e.g., FP, pediatrician, teacher).
15910509|NCT03569449|Behavioral|:Individually-tailored visits|Family Partners will be able to meet with families on an as-needed basis, with no predetermined schedule of contacts
15910510|NCT03569449|Behavioral|Clinic-based visits and community visits|In clinic-based visits the Family Partner is restricted to working at the primary care clinic and communication is restricted to telephone, text, and clinic visits. However in conditions with clinic based and community visits, the Family Partners will be available to meet families in their home and community (as well as the clinic), and accompany families to community-based meetings at school or childcare.
15910511|NCT03569436|Other|Non-Interventional|Non-Interventional
15910512|NCT03569423|Procedure|Transepithelial photorefractive keratectomy|ablations were performed with the Schwind Amaris excimer LASER 750S. Paired student's t-tests and Mann-Whitney tests were used for statistical analysis.
15910513|NCT03569423|Procedure|Alcohol assisted photorefractive keratectomy|ablations were performed with the Schwind Amaris excimer LASER 750S. Paired student's t-tests and Mann-Whitney tests were used for statistical analysis.
15910514|NCT03569410|Behavioral|increased protein intake via natural foods|Patients had to eat 1.4g/kg/day of natural protein.
15910515|NCT03569410|Behavioral|increase protein intake via protein supplements|Patients ate enough protein supplements in addition to their regular diet to reach eat 1.4g/kg/day of protein intake.
15910516|NCT03569397|Other|Music Therapy|Patients will be administered music therapy during the operation.
15910517|NCT03569384|Combination Product|Tele Rehab|The intervention group will obtain telerehabilitation
15910518|NCT03569371|Drug|INCB054707|INCB054707 administered once daily orally with water without regard to food for 8 weeks.
15910519|NCT03569358|Device|Immersive Virtual Reality|The immersive virtual reality headgear used is the commercially available FOVE VR headset. It incorporates a 2560x1440 pixel display, position tracking-and eye-tracking. The headset weight 520g with adjustable velcro straps. Softwares are run via a computer connected by HDMI or USB cables.
15910520|NCT03569358|Device|EEG headband|The EEG headband is commercially available MUSE band. It incorporates 4-channel dry electrode EEG system where data can be recorded with bluetooth connection.
15910521|NCT03569345|Drug|AFXl-assisted ingenol mebutate delivery|"Patients will receive ablative fractional laser (AFXl)-assisted ingenol mebutate (IM) as a treatment for their cutaneous basal cell carcinoma (BCC). Treatment areas consisting of tumors and a 5 mm margin will undergo AFXl exposure (CO2 laser) followed by IM 0.015% or 0.05% under occlusion for 2-3 days. .
~local skin reactions are monitored at baseline (day1), day 3/4, day 8, day 15, day 29, day 90, and tumor response monitored at baseline, day 29, and day 90. An additional repeat AFXl-IM treatment on day 29 will be offered if tumors persist, based on clinical evaluation and imaging on day 30."
15910522|NCT03569332|Other|Alarm|"Alarm is provided from 9am to 9pm.
~Alarm is active every 50 minutes if the exercise goal(10 times/hour) hasn't satisfied."
15910524|NCT03569319|Behavioral|"THINK-MED resource (baseline)"|"The THINK-MED resource contains an information booklet, recipe books, menu plan cards, shopping list cards and goal setting cards. Participants will receive this resource on one occasion at baseline."
15910525|NCT03569319|Behavioral|"THINK-MED resource (staged)"|"This group of participants will receive the THINK-MED resource at monthly intervals for 5 months accompanied by telephone feedback from the research dietitian"
15910526|NCT03569319|Behavioral|Control|"Participants will receive the THINK-MED resource after their final 6 month study visit (i.e. delayed intervention)."
15910527|NCT03569306|Device|ENB|ENB is carried out by a ENB system（LungCare, China) which can offer real-time navigation for bronchoscopy reaching peripheral pulmonary nodules.
15910528|NCT03569306|Device|EBUS-GS|EBUS is performed using an endoscope ultrasound system , which is equipped with a 20-MHz mechanical radial-type probe (UM-S20-17S;Olympus) with an external diameter of 1.4 mm and a GS (K-201; Olympus).
15910529|NCT03569293|Drug|Upadacitinib|It is administered orally.
15910530|NCT03569293|Drug|Placebo for Upadacitinib|It is administered orally.
15910531|NCT03569280|Combination Product|Enzalutamide or Abiraterone or Apalutamid|Antitumor treatment
15910532|NCT03569267|Drug|OLX10010|A cell penetrating asymmetric siRNA (cp asiRNA)
15910533|NCT03569267|Drug|Placebo|Placebo
15910534|NCT03569254|Device|Neomedlight Phototherapy Blanket|The NeoMedLight® phototherapy blanket is an innovative new fiber-optic device based on LED light. Its light emitting surface area is 40.5x30 cm or 1200 cm2. The device size is 40.5 x30 cm. It incorporates fiber optic mesh and is protected by a vinyl cover and a disposable liner for patient comfort and hygiene. This device provides therapeutic light (404-515nm) to a wide extension of the body surface area. Its average irradiation footprint is 35uW / cm2 / nm ± 15%. The phototherapy was done intermittently in periods of 2 hours with 1 hour of rest for a total time of 6 hours in kangaroo position.
15910535|NCT03569254|Device|Ohmeda-Fiber Optic Phototherapy Blanket|This device is a high performance version of Ohmeda Medical's Biliblanket that uses a fiber optic cable to deliver light from a high-intensity lamp to a device composed of a fiber optic fabric. The device has a disposable liner and is left in direct contact with the patient. The patient is exposed to a light with a wavelength between 400 and 550 nanometers. The phototherapy system consists of a light emitting unit, a fiber optic cable four feet long (121.9 cm) and a lightweight mattress. It has two available sizes: 4.38 x 9.38 inches (11.12 x 23.83 cm) and 4.00 x 6.00 inches (10.16 x 15.2 cm).
15910536|NCT03569241|Radiation|whole pelvic radiotherapy|addition of prophylactic whole pelvic radiotherapy to a local metastasis-directed treatment
15910537|NCT03569241|Radiation|metastasis-directed treatment|stereotactic body radiotherapy
15910538|NCT03569241|Procedure|salvage Lymph Node Dissection|metastasis-directed treatment
15910539|NCT03569241|Drug|androgen deprivation therapy|LHRH-agonist (+ anti-androgen) or antagonist for a duration of 6 months
15910540|NCT03569228|Device|Study 1 - ITE hearing aids|Experienced users of in-the-ear (ITE) hearing aids will receive replacement ITE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.
15910541|NCT03569228|Device|Study 1 - BTE hearing aids|Experienced users of behind-the-ear (BTE) hearing aids will receive replacement BTE hearing aids that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.
15910542|NCT03569228|Device|Study 3 (open-fit comparison)|This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling using the standard of care approach, then undergoing a 4-week field trial.
15910543|NCT03569228|Device|Study 3 (closed-fit comparison)|This group will serve as the active comparator group for experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling using the standard of care approach, then undergoing a 4-week field trial.
15910544|NCT03569228|Device|Study 3 (experimental open-fit)|Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with OPEN coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.
15910545|NCT03569228|Device|Study 3 (experimental closed-fit)|Experienced hearing aid user receiving replacement receiver in the canal (RIC) or receiver in the aid (RITA) hearing aids with CLOSED coupling that are fitted and verified in a test box coupler, then mailed to the patient for a 4-week field trial.
15910546|NCT03569215|Behavioral|Questionnaire|All included patients will be exposed to questionnaires and psychiatric diagnostic tests
15910547|NCT03569202|Device|Piiloset Trehalose Emulsion Eye Drops|Topical application of preservative-free multidose Piiloset Trehalose Emulsion Eye Drops 3 times daily
15910548|NCT03569202|Device|Control Eye Drops|Topical application of preservative-free multidose Hyaluronic Acid Eye Drops 3 times daily
15910549|NCT03569189|Other|High Fat Diet|"Participants will consume a high fat diet for 7 days with 65% of energy from fat. The diet will also provide an energy excess at 150% of energy requirements.
~Participants will be provided with all of their meals and snacks throughout the study."
15910550|NCT03569176|Device|Autism Glass|The intervention uses the outward-facing camera on the google glasses to read facial expressions and provides social cues within the child's natural environment during usual social interaction and during games accessed via the smartphone application. Participants who receive the Google Glass intervention will be asked to use it for around 20 minutes 3 times a week with their parents or during ABA therapy.
15910551|NCT03569163|Device|Spry Loop oximeter|Oximetry was performed on the subjects and accuracy was determined based on comparison with blood gas analysis.
15910552|NCT03569150|Other|Cultural adaptation/implementation COMFORT CC|The COMFORT Communication Curriculum (CC) will be culturally-adapted for 2 Native American reservation communities. The investigators will then implement the culturally-adapted COMFORT Communication Curriculum in 2 tribal communities by training interdisciplinary healthcare professionals to conduct culturally-respectful and relevant Advance Care Planning. The investigators will then conduct a cluster-assigned pilot, wait-list controlled trial of the culturally-adapted COMFORT Communication Curriculum in 2 tribal communities to evaluate feasibility, acceptability, and perceived effectiveness by comparing 30 Native Americans completing Advance Care Planning with a trained healthcare professional and 30 Native Americans receiving usual care.
15910799|NCT03567395|Dietary Supplement|Melatonin|Melatonin (5 mg sublingual tablet) administered for 3 days
15910553|NCT03569124|Other|Teaching tool for identification of colorectal polyps|This is a teaching session on how to identify the colorectal polyps shot in blue light imaging.
15910554|NCT03569111|Device|Bronchoscopic ablation catheter|The Emprint™ Ablation Catheter Kit with Thermosphere™ Technology is deployed endoscopically and will be used to conduct bronchoscopic ablations in the lung using the superDimension™ navigation system.
15910555|NCT03569098|Biological|Botulinum toxin type A|Investigators will inject the reconstituted solution into foot muscles.
15910556|NCT03569098|Drug|Placebo|Investigators will inject the reconstituted solution into foot muscles.
15910557|NCT03569085|Drug|Sevoflurane|The patient will receive Sevoflurane in incremental doses titrated to obtain end-tidal minimum alveolar concentration (MAC) of 0.5, 1.0, and 1.5.
15910558|NCT03569085|Drug|Isoflurane|The patient will receive isoflurane in incremental doses titrated to obtain end-tidal minimum alveolar concentration (MAC) of 0.5, 1.0, and 1.5.
15910559|NCT03569072|Radiation|Functionally adapted, dose escalated VMAT radiotherapy|Volumetric Modulated Arc Therapy planning and treatment delivery to treat primary and nodal planning target volume with 60 Gy in 30 fractions and a simultaneous integrated boost to the primary tumour to a total dose 69Gy in 30 fractions while avoiding organs at risk including functional lung, heart and oesophagus.
15910560|NCT03569059|Device|Early Robotic/VR Therapy (EVR)|Subjects will perform state-of-art inpatient usual care therapy. In addition, they will perform an extra 1-hour/day of intensive therapy focusing on the hand in the form of interactive virtual reality games while assisted by robots. This additional treatment will be initiated 5-30 days post stroke.
15910561|NCT03569059|Behavioral|Dose-Matched Usual Physical Therapy Care|Subjects will perform state-of-art usual physical/occupational care and 10 days of one additional hour of state-of-art usual inpatient and/or outpatient physical therapy/occupational therapy.
15910562|NCT03569059|Device|Delayed Robotic/VR Therapy (DVR)|Subjects will perform state-of-art inpatient usual care therapy. In addition, they will perform an extra 1-hour/day of intensive therapy focusing on the hand in the form of interactive virtual reality games while assisted by robots. This additional treatment will be initiated 31-60 days post stroke.
15910563|NCT03569046|Drug|local anaesthetic injection|ear block by 0.25% bupivacaine
15910564|NCT03569046|Drug|Normal Saline Flush, 0.9% Injectable Solution|ear block by Normal Saline Flush, 0.9% Injectable Solution
15910565|NCT03569046|Drug|general anesthetic|general anesthetic by midazolam 0.02 mg kg-1 , propofol 2-3 mg kg-1 and lidocaine 0.5 mg kg-1 , fentanyl 2 μg kg-1 , atracurium 0.5 mg kg-1 , isoflurane in 50% oxygen/air.
15910566|NCT03569046|Drug|Hypotensives|hypotensives for deliberate hypotension by nitroglycerine 0.5-10 μg /kg/min and increments of 0.2 mg propranolol
15910567|NCT03569033|Drug|Gefapixant|Gefapixant 45 mg will be administered orally.
15910568|NCT03569033|Drug|Placebo|Placebo tablet matching gefapixant will be administered orally.
15910569|NCT03569020|Other|Subsidy for food purchases and dietitian education|$105/wk of DASH-like foods over 4 weeks purchased with the help of a dietitian in a proportion that reflects the DASH diet.
15910570|NCT03569007|Drug|Larazotide|Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules
15910571|NCT03569007|Drug|Matching Placebo|enteric-coated beads in gelatin capsules
15910577|NCT03568981|Radiation|Partial breast irradiation|After breast- conservating surgery, all patients are allowed to receive partial breast irradiation or whole breast irradiation after surgery according to the international guidelines and physician's discretion.
15910578|NCT03568981|Radiation|Whole breast irradiation|After breast- conservating surgery, all patients are allowed to receive partial breast irradiation or whole breast irradiation after surgery according to the international guidelines and physician's discretion.
15910579|NCT03568968|Dietary Supplement|Nicotinamide Riboside|1000mg one time daily. Given as tablets. Duration of the trial, 52 weeks.
15910580|NCT03568968|Drug|Placebo|Placebo drug, given 1 time daily for the duration of the trial; 52 weeks.
15910581|NCT03568955|Diagnostic Test|International Prolonged Grief Disorder Scale (IPGDS)|Assessment measure for Prolonged Grief disorder based on the ICD-11 (International Classification of Disorders) criteria for PGD (Prolonged Grief Disorder). 15 items
15910582|NCT03568942|Drug|Gepotidacin|Gepotidacin tablets will be available at a dose strength of 750 mg. Tablets will be administered BID with water after consumption of food.
15910584|NCT03568916|Drug|Apixaban (ATC B01AF02)|Exposure to apixaban (ATC B01AF02) will be defined as a new prescription for apixaban at cohort entry date in patients diagnosed with non-valvular atrial fibrillation. Patients are considered exposed until end of follow-up regardless of switch or interruption.
15910585|NCT03568916|Drug|Dabigatran (ATC B01AE07)|Exposure to dabigatran (ATC B01AE07) will be defined as a new prescription for dabigatran at cohort entry date in patients diagnosed with non-valvular atrial fibrillation. Patients are considered exposed until end of follow-up regardless of switch or interruption.
15910586|NCT03568916|Drug|Rivaroxaban (ATC B01AF01)|Exposure to rivaroxaban (ATC B01AF01) will be defined as a new prescription for rivaroxaban at cohort entry date in patients diagnosed with non-valvular atrial fibrillation. Patients are considered exposed until end of follow-up regardless of switch or interruption.
15940036|NCT03341299|Biological|LY900014|Administered SC
15910587|NCT03568903|Other|Comprehensive physical therapy|Each session included exercises for posture, strength, range of motion, balance. In addition, different transfers and gait training was performed. Each session began with exercises in laying position (15 minutes), thereafter exercises in sitting were performed for 10 minutes. Then different exercises in standing position were performed for 15 minutes, followed by 10 minutes of gait training. 10 minutes of exercises for manual dexterity and upper limb function ended the session.
15910588|NCT03568890|Drug|Rivaroxaban, dabigatran, apixaban, or edoxaban|Duration of treatment: 8 weeks
15910589|NCT03568890|Drug|Clopidogrel -75 mg/day|Duration of treatment: 8 weeks
15910590|NCT03568890|Drug|Low dose aspirin -80 to 125 mg/day-|Duration of treatment: 8 weeks
15910591|NCT03568877|Dietary Supplement|Metabolaid®|500 mg per day, in fasting conditions.
15910592|NCT03568877|Dietary Supplement|Placebo|500 mg per day, in fasting conditions.
15910593|NCT03568864|Other|Low nucleotide meal|The participants will consume a mixed meal (sandwich) containing a nucleotide depleted mycoprotein product (low in nucleotides)
15910594|NCT03568864|Other|High nucleotide meal|The participants will consume a mixed meal (sandwich) containing a non nucleotide depleted mycoprotein product (high in nucleotides)
15910595|NCT03568838|Drug|Enoxaparin|Patients allocated to the experimental arm will receive a parenteral (IA/IV) bolus dose of enoxaparin (0.75 mg/kg) pre PPCI followed by an infusion of 0.75 mg/kg over a 6-hour period to be started as soon as possible when PPCI starts.
15910596|NCT03568825|Procedure|Osteopatic Manual Therapy (OMT)|OMT consisting of following interventions; thoracic spine and diaphragm mobilisation, traction of the cardia and posture correction.
15910597|NCT03568812|Drug|Rillus®|Eligible subjects will be divided into 2 groups randomly (Rillus® or placebo). The colour, smell, flavour, and size of the chewing tablet are the same between active and placebo drugs. Subjects will consume the tablet once daily at night for 12 weeks.
15910598|NCT03568812|Other|Placebo|Eligible subjects will be divided into 2 groups randomly (Rillus® or placebo). The colour, smell, flavour, and size of the chewing tablet are the same between active and placebo drugs. Subjects will consume the tablet once daily at night for 12 weeks.
15910599|NCT03568799|Radiation|18F-(2S,4R)4-fluoroglutamine|Undergo 18F-(2S,4R)4-fluoroglutamine PET/CT
15910600|NCT03568786|Procedure|End-inspiratory pause 10%|Percentage of the total inspiratory time in which there is no gas flow. It is the period of time between the cessation of the inspiratory flow and the start of expiration. In this intervention arm it would correspond to a 10% of the total inspiratory time
15910601|NCT03568786|Procedure|End-inspiratory pause 30%|Percentage of the total inspiratory time in which there is no gas flow. It is the period of time between the cessation of the inspiratory flow and the start of expiration. In this intervention arm it would correspond to a 30% of the total inspiratory time
15910602|NCT03568773|Other|High-intensity interval training|HIIT training is being conducted on a three-day weekly frequency on a stationary bike. The protocol consisted of two weeks of adaptation with 12 weeks of training that alternated between sprints ranging from 30 s to 60 s (> 95% VO2max), and active recovery ranging from 180 s to 120 s (30 W on the bicycle).
15910603|NCT03568773|Other|Aerobic exercise moderate intensity|The aerobic training is performed in a walking or running mode, with three weeks of adaptation (2x / wk - 20 to 30 minutes / session, <threshold 1) and 12 weeks of training (3 to 5x / wk - 40 to 60 minutes / session, with prescribed intensities between the anaerobic threshold - L1 and the respiratory compensation point - L2).
15910604|NCT03568773|Other|Control Group|The control group is participating in lengthening classes to increase the adherence and control of the influencing variables. Classes are being held once a week for 60 minutes.
15910605|NCT03568760|Behavioral|Semantic feature analysis|Confrontation naming training and training in doing circumlocutions
15910606|NCT03568760|Behavioral|Comprehension training|Reading and hearing comprehension
15910607|NCT03568747|Device|noninvasive ventilation|dual-limb circuit NIV were given on maquet servo i apparatus
15910608|NCT03568747|Device|oxygen therapy|oxygen therapy were introduced to the side port of the facemask
15910609|NCT03568734|Other|Fecal transplant|At delivery, i.e. 39-40 weeks of gestation, the newborn infant is given 0.1 g maternal fecal sample (in 0.5 ml of the isotonic saline+10 % glycerol) dissolved in 10 ml of bank milk orally. The sample is given within 2 h of birth. Milk containing fecal sample (2 ml) is given as a part of a total feeding of 5-10 ml.
15910610|NCT03568721|Drug|Ibuprofen|prescription of ibuprofen 400 mg
15910611|NCT03568721|Drug|Acetaminophen|prescription of acetaminophen 500 mg
15910612|NCT03568721|Other|Chewing gum|prescription of one tablet of chewing gum
15910613|NCT03568708|Drug|Transdermal Estrogen|In an open-label fashion, participants with POI will receive transdermal estradiol (beginning at a dose of 25 µg/patch applied weekly), with the dose increased at 3, 6 12, and 18 months (to 37.5, 50, 75, and 100 µg/patch).
15910614|NCT03568695|Diagnostic Test|Two samples on each of the three sites (pharynx, rectum, urine)|two new samples on each of the three sites (pharynx, rectum, urine) which will make it possible to compare the difference of sensitivity between real-time multiplex PCR from pools of 3 samples and the usual technique .
15910615|NCT03568682|Behavioral|Nutritional counseling + urban gardening|Peer nutritional counseling and urban gardens
15910616|NCT03568669|Other|NIH Toolbox Cognition Battery|An app-based cognitive assessment of executive function, attention, memory, and language that takes approximately 45 minutes to complete on an iPad
15910620|NCT03568643|Drug|Azithromycin|Children enrolled in the trial and randomized to azithromycin will receive a single directly observed dose of oral azithromycin at 20 mg/kg up to the maximum adult dose of 1 g. Oral azithromycin will be administered at the time of enrollment. Enrolled children will also receive RUTF.
15910621|NCT03568643|Drug|Amoxicillin|Children enrolled in the trial and randomized to azithromycin will receive a 7-day course of oral amoxcillin given in twice-daily doses of 50-100 mg/kg, per the Burkina Faso guidelines for the management of severe acute malnutrition. The first dose will be administered at the time of enrollment and the remaining dose will be administered by the caregiver at home. Enrolled children will also receive RUTF.
15910800|NCT03567395|Dietary Supplement|Honey|Raw Honey (1.5 tablespoons) administered for 3 days
15910622|NCT03568630|Diagnostic Test|Mixed Meal Tolerance Test|The goal of the test is to determine hormone secretion from the pancreas and small intestine in response to the mixed meal.
15910623|NCT03568630|Diagnostic Test|Hemoglobin A1c|This test provides the average level of blood glucose over the last 3 months.
15910624|NCT03568630|Diagnostic Test|Other exploratory blood biomarkers|Other exploratory blood biomarkers including cell free DNA and other markers in development
15910625|NCT03568617|Device|rTMS|The subjects will receive 20 trains of 100 stimuli each delivered at 10 Hz and 80% of MT over the left MC (M1), 3 days a week, for 4 weeks.
15910626|NCT03568604|Drug|Prasterone|6.5 vaginal insert prasterone (dehydroepiandrosterone)
15910627|NCT03568591|Procedure|Psychosensory Therapy|Havening Techniques are a psychosensory therapy that incorporate the application of sensory input to alter neurochemical responses influencing thought, emotion and behaviour (Ruden, 2011).
15910628|NCT03568578|Drug|Entecavir 0.5 mg|Patients in this group will be given Entecavir 0.5 mg a day for 2 years.
15910629|NCT03568578|Drug|Anluohuaxian Pill 12g|Patients in this group will be given Entecavir 0.5 mg and Anluohuaxian Pill 12g a day for 2 years
15910630|NCT03568565|Behavioral|ePREP Program|see arm descriptions
15910631|NCT03568565|Behavioral|OurRelationship Program|see arm descriptions
15910632|NCT03568552|Behavioral|Patient Decision Aid|PtDA-MAT will provide information on MAT treatment options and pros and cons of each treatment option, and will assess patients' preferred options.
15910633|NCT03568539|Drug|IBI308|IBI308 200mg IV infusion, every 3 weeks.
15910634|NCT03568526|Other|Educational Intervention|Attend a therapy session
15910635|NCT03568526|Behavioral|Exercise Intervention|Complete exercise
15910636|NCT03568526|Other|Quality-of-Life Assessment|Ancillary studies
15910637|NCT03568526|Other|Questionnaire Administration|Ancillary studies
15910638|NCT03568526|Other|Survey Administration|Ancillary studies
15910639|NCT03568513|Dietary Supplement|Curcumin|The curcumin food supplement will be administered in the form of capsules. Participants in the treatment arm will take 50 mg twice or three times a day, depending on their body weight. Participants will take the curcumin capsules for eight weeks.
15910640|NCT03568513|Dietary Supplement|Placebo|The placebo will be administered in the form of capsules. Participants in the placebo arm will take a capsule twice or three times a day, depending on their body weight. Participants will take the placebo capsules for eight weeks. The placebo capsule will be similar in size, shape and color to the curcumin capsule and they will contain inert food powder.
15910641|NCT03568500|Device|Digital Medicine System|DMS components: a CoE product consisting of an approved antipsychotic medicinal product co-encapsulated with Conformité Européenne (CE)-marked miniature ingestible event marker in tablet; a CE-marked compatible medical device (a Proteus Patch [Disposable Wearable Sensor Version 5]); proprietary medical software (a local and remote computing application).
15910642|NCT03568500|Drug|Aripiprazole|Dosage determined by the healthcare professionals.
15910643|NCT03568500|Drug|Olanzapine|Dosage determined by the healthcare professionals.
15910644|NCT03568500|Drug|Quetiapine|Dosage determined by the healthcare professionals.
15910645|NCT03568500|Drug|Risperidone|Dosage determined by the healthcare professionals.
15910646|NCT03568487|Other|Intensive scapula-focused approach|scapula-focused approach with exercises, 3 x 20 min training per week for 4 weeks
15910647|NCT03568487|Other|Control Therapy|not have any physical training but is encouraged to stay active as usual.
15910648|NCT03568474|Drug|Silver Diamine Fluoride|Indirect pulp capping material
15910649|NCT03568474|Drug|Glass Ionomer|Indirect pulp capping material
15910650|NCT03568461|Biological|tisagenlecleucel|single infusion
15910651|NCT03568448|Other|Response monitoring (no intervention)|Response monitoring (no intervention)
15910652|NCT03568435|Other|Non-Interventional|Non-Interventional
15910653|NCT03568422|Drug|CFI-402257|Orally taken on intermittent schedule (days 1, 2, 8, 9, 15 & 16
15910654|NCT03568422|Drug|Paclitaxel|80 mg/m2 IV days 1, 8 & 15 every 28 days
15910655|NCT03568409|Device|ABO-GLYC|3 tablets twice a day, before the main meals (lunch and dinner) continuatively for 24 weeks.
15910656|NCT03568409|Other|ABO-GLYC Placebo|3 tablets twice a day, before the main meals (lunch and dinner) continuatively for 24 weeks.
15910657|NCT03568396|Device|Pupillometer|Measurement of pupil diameter and reactivity in response to a standard noxious stimulus in cardiac surgery during extracorporeal circulation period.
15910658|NCT03568383|Drug|Delamanid (DLM)|"Adults and children ≥30 kg: delamanid 200 mg orally once daily.
~Children ≥2.5 kg to <30 kg: weight-band dosing orally once daily as per the study protocol. As children gain weight, their DLM dose should be adjusted, typically every month or as the visit schedule permits."
15910659|NCT03568383|Drug|Isoniazid (INH)|"Adults and children ≥24 kg: INH 300 mg orally once daily.
~Children ≥2.5 kg to <24 kg: INH weight-band dosing orally once daily as per the study protocol. As children gain weight, their INH dose should be adjusted."
15910660|NCT03568383|Dietary Supplement|Pyridoxine (vitamin B6)|All HHCs in Arm B must receive pyridoxine (vitamin B6) with each dose of INH based on the current local dosing guidelines. For children up to 3 years of age and nursing women, pyridoxine will be given as per local standard of care. Pyridoxine is not supplied through the study.
15910661|NCT03568370|Other|olive oil|Evaluate the effectiveness of olive oil and human milk in the prevention of nipple cracking, nipple pain and maternal satisfaction in lactating women during the first 3 days of treatment and the 7th and 10th day after delivery.
15910662|NCT03568357|Procedure|Reoxygenation|After one minute of full bypass, fraction of inspired oxygen (FiO2) in conservative group was increased at increments of 0.1 per minute to reach an FiO2 target of 40% that was adjusted to maintain an arterial PO2 in the range of 250 mm Hg or less during the bypass, while FiO2 in liberal group was increased at increments of 0.1 per minute to reach a FiO2 target of 80% adjusted to maintain PO2 in the range of 300 mm Hg or more, on the basis of arterial PO2 level measured via a point of care blood gas analyzer.
15910663|NCT03568331|Drug|Tradipitant|Oral Capsule
15910664|NCT03568331|Drug|Placebo|Oral Capsule
15910665|NCT03568318|Drug|Upadacitinib|It is administered orally.
15910666|NCT03568318|Drug|Placebo for Upadacitinib|It is administered orally.
15910667|NCT03568318|Drug|Topical corticosteroids (TCS)|It is administered concomitantly with Upadacitinib or Placebo.
15910672|NCT03568279|Procedure|Two-handed jaw thrust|The assistant applied two-handed jaw thrust for intubation.
15910673|NCT03568279|Procedure|Control|The intubation was done without two-handed jaw thrust.
15910674|NCT03568266|Procedure|Biospecimen Collection|Undergo collection of saliva
15910675|NCT03568253|Other|Caries treatment|Treatment by Bulk fil composite after randomization of the tooth
15910676|NCT03568253|Other|Caries treatment|Treatment by High viscosity glass ionomer after randomization of the tooth
15910677|NCT03568240|Diagnostic Test|Patients suffering from Sleep apnea|PSG test
15910678|NCT03568227|Procedure|Hypnosis|The hypnosis intervention consists of two elements: A hypnotic induction and a hypnotic deepening. The induction aims at guiding the participant into the first hypnotic state (state 1). The participants will remain in this state for 10 minutes, the duration of the fMRI-scan. The hypnotic deepening guides the participants into a very deep hypnotic state (state 2). Participants also remain in this state for 10 minutes, during which their brain activity is measured using fMRI
15910679|NCT03568227|Procedure|Control|The control intervention consists of texts corresponding to the induction and deepening of the hypnosis intervention. They are matched in duration and consist of textually matched excerpts from www.wikipedia.org. Control induction will be presented, resulting in the control state 1 (10 min). Then the control deepening will be performed, leading to the control state 2 (10 minutes). During both control states the brain activity will be recorded using fMRI.
15910680|NCT03568214|Other|Exercise|The MICT will be prescribed according to two exercise intensity methods: individualized (i.e., VT1 and VT2) and standardized (i.e., HRR). The HIIT will be prescribed based on individual fitness (i.e., VO2max).
15910681|NCT03568201|Diagnostic Test|Transcutaneous oximetry|Measurement of TcpO2 on calves and chests. Calculation of the DROP index (decrease from rest of oxygen pressure)on both calves.
15910682|NCT03568188|Procedure|treatment with focal HIFU|HIFU treatment will be conducted with the Focal One® device. The treatment area will be defined using MRI data and 3D biopsies. A safety distance of at least 9 mm will be defined around the tumor. An intraoperative contrast echocardiographic control will be performed to evaluate the necrotic area. If necessary, additional HIFU lesions will be performed during the same session. In case of residual tumor demonstrated during control biopsies, additional treatment of this tumor with focal HIFU may be proposed.
15910683|NCT03568188|Biological|PSA dosage|PSA dosage will be regularly performed during patient follow up thanks to blood sampling.
15910684|NCT03568188|Device|MRI|MRI exam will be regularly performed during patient follow up.
15910685|NCT03568188|Other|Questionnaires|Patients will have to complete five questionnaires during their follow up : QLQ-C30 (Quality of Life questionnaire), EPIC-26 (The Expanded Prostate Cancer Index Composite), IPSS (International Prostate Score Symptom), IIEF-5 (The International Index of Erectile Function).
15910686|NCT03568188|Procedure|Prostatic biopsies|Prostatic biopsies will be regularly performed during patient follow up.
15910687|NCT03568188|Biological|blood test|if the patient decides to participate in the ancillary study, a blood test (for immunological analyzes and detection of CTC (circulating tumor cells)) will be performed during their follow up.
15910688|NCT03568188|Biological|urine test|if the patient decides to participate in the ancillary study, a urine test (for PCA3 test) will be performed during their follow up.
15910689|NCT03568175|Drug|JR-141|IV infusion, 2.0 mg/kg/week
15910690|NCT03568162|Drug|ISB 830 - Part 1 Group 1|Subcutaneous injection (SC) every 2 weeks
15910691|NCT03568162|Drug|ISB 830 - Part 1 Group 2|Subcutaneous injection (SC) every 2 weeks
15910692|NCT03568162|Drug|ISB 830 - Part 1 Group 3|Subcutaneous injection (SC) every 2 weeks
15910693|NCT03568162|Drug|Placebo - Part 1 Group 4|Subcutaneous injection (SC) every 2 weeks
15910694|NCT03568162|Drug|ISB 830 - Part 2 Group 5|Subcutaneous injection (SC) every 2 weeks
15910695|NCT03568162|Drug|Placebo - Part 2 Group 6|Subcutaneous injection (SC) every 2 weeks
15910696|NCT03568149|Procedure|assessment of pain symptoms at first medical examination|First medical examination consists of collection of medical history and standard gynecological examination (bimanual gynecological examination and abdominopelvic ultrasounds). Data regarding age, Body Mass Index, ongoing hormone therapy and pelvic pain symptoms, assessed according to Visual Analogue Scale (VAS) (from 0= no pain to 10= unbearable pain), are collected. The presence of perineal or lower limb varices and the presence and localization of evoked pain at bimanual gynecological examination are also evaluated.
15910697|NCT03568149|Procedure|assessment of pelvic vascular insufficiency signs|"Assessment of pelvic vascular insufficiency in conducted using abdominopelvic ultrasounds, according to the following parameters:
~Ovarian vein diameter <4mm
~Slow ovarian blood flow (<3cm/sec)
~Retrograde blood flow
~Dilated arcuate veins communicating with pelvic varices The presence of pelvic varices is evaluated qualitatively as normal, moderate and serious
~This evaluation includes the study of uterine and ovarian vessels, using different techniques:
~Standard 2D study, to measure vessels diameter
~Vascular doppler study, to evaluate flow direction and blood speed
~3D color study, for a three- dimensional reconstruction of vessels and a more accurate qualitative assessment of the congestion degree."
15910698|NCT03568136|Drug|Secukinumab 300 mg|Solution for injection in pre-filled syringe
15910699|NCT03568136|Drug|Placebo|Solution for injection in pre-filled syringe
15910700|NCT03568123|Device|MC polyethylene bearing|"Zimmer Biomet Persona Total Knee System with MC polyethylene bearing. Femoral component: Only cemented femoral components will be used for this study. Both standard as well as narrow femoral components will be used, depending on the patient anatomy.
~Tibial component: Only cemented tibial components will be used for this study. Polyethylene materials: Conventional polyethylene will be used for patients >65 years old and Vitamine-E infused poly insert for patients ≤ 65 years old."
15910701|NCT03568123|Device|CR polyethylene bearing|"Zimmer Biomet Persona Total Knee System with CR polyethylene bearing. Femoral component: Only cemented femoral components will be used for this study. Both standard as well as narrow femoral components will be used, depending on the patient anatomy.
~Tibial component: Only cemented tibial components will be used for this study. Polyethylene materials: Conventional polyethylene will be used for patients >65 years old and Vitamine-E infused poly insert for patients ≤ 65 years old."
15910702|NCT03568097|Drug|Avelumab|10 mg/kg will be given as intravenous infusion (IV) every two weeks (q 2 weeks) until disease progression.
15910705|NCT03568071|Drug|MOR 106|The active pharmaceutical drug substance of MOR106 is a human immunoglobulin gamma-1 (IgG1) monoclonal antibody that binds with a high apparent affinity to human IL-17C.
15910706|NCT03568071|Drug|Placebo|A sodium chloride infusion container with IV solution without addition of MOR106 drug product will be used as placebo in the proposed clinical study.
15910707|NCT03568058|Drug|personalized vaccine|Vaccine will be constructed for each subject that express multiple candidate tumor-derived neoantigens.
15910708|NCT03568058|Drug|Pembrolizumab|200 mg pembrolizumab will be administered intravenous (IV) infusion every 3 weeks.
15910709|NCT03568045|Device|standard light|usual care
15910710|NCT03568045|Device|10,000 lux bright light, 4 hours|Bright light will be delivered by a free-standing 10,000 lux device that will be positioned next to the patient's head of bed. At the estimated distance of 36 inches from light source to the patient, we anticipate approximately a 1,250 lux dose at the patient's eye. Light will be delivered from 8am to noon.
15910711|NCT03568045|Device|10,000 lux bright light, 8 hours|Bright light will be delivered by a free-standing 10,000 lux device that will be positioned next to the patient's head of bed. At the estimated distance of 36 inches from light source to the patient, we anticipate approximately a 1,250 lux dose at the patient's eye. Light will be delivered from 8am to 4pm.
15910712|NCT03568032|Diagnostic Test|Measurement of intima media thickness of carotid artery|IMT measurements were performed using ultrasound machine in the pre-radiation and the post-radiation group. IMT was assessed at the common carotid artery (CCA) and the internal carotid artery (ICA) of both the left and right side.
15910713|NCT03568032|Diagnostic Test|Detection and measurement of carotid plaques|Detection and measurement of plaques within internal carotid artery and common carotid artery by ultrasound
15910714|NCT03568032|Diagnostic Test|Carotid Color Flow Duplex Testing|Velocity measurement of carotid artery to determine carotid stenosis
15910715|NCT03568032|Diagnostic Test|Montreal Cognitive Assessment|Cognitive assessment
15910716|NCT03568032|Other|Medical history of cardiovascular risk factors and cardiovascular diseases|Cardiovascular risk factors include smoking, alcohol consumption, hypertension, diabetes mellitus, hypercholesterolemia, obesity. Cardiovascular diseases include ischemic stroke, ischemic coronary heart disease, TIA, etc.
15910717|NCT03568019|Other|Retrospective study|No subjects will be contacted or recruited. All data will be acquired retrospectively.
15910718|NCT03568006|Other|Specific passive mobilization|Specific passive mobilizations for the shoulder
15910719|NCT03568006|Other|Standardized treatment (standard protocol)|Infrared rays, a program of therapeutic exercises and indications to improve their postural hygiene
15910720|NCT03567993|Behavioral|Comparison|Participants randomized to the comparison arm will receive twice-monthly abstinence assessments from the text messaging system, with no motivational feedback. Those in the comparison arm are neither offered nor encouraged to participate in the intervention.
15910721|NCT03567993|Behavioral|Intervention|"Participants randomized to the intervention arm will receive:
~Motivational Messages
~Abstinence and Motivation to Use Services Assessments
~Encouragement to access the Quitline
~Encouragement to use Nicotine Replacement Therapy (NRT)
~Provision of NRT, if requested
~Intervention subjects are encouraged to access the Quitline and use NRT. However, these are not mandatory components of the intervention and subjects can choose if they would like to engage with the Quitline or use NRT."
15910723|NCT03567967|Behavioral|Fruit and vegetable voucher|Participants will receive four vouchers, each dated for a month, to be used on fruits and vegetables at specified local corner stores, supermarkets, and farmer's markets for a duration of six months. Each study participant will have the same intervention, as this is a non-inferiority trial to compare voucher use in LA and test whether the nutritional effects of that use are non-inferior to use in SF.
15910724|NCT03567954|Diagnostic Test|Ultrasound examination of the rotator cuff tendons|An ultrasound scan of the rotator cuff tendons will be performed to determine the presence of a rotator cuff tear or not
15910725|NCT03567941|Drug|Placebo|Tablet orally administered under fasting
15910726|NCT03567941|Drug|Hydrocodon bitartrate-acetaminophen arm 1|Tablet orally administered under fasted conditions
15910727|NCT03567941|Drug|Hydrocodon bitartrate-acetaminophen arm 2|Tablet orally administered under fed conditions
15910728|NCT03567941|Drug|Reference|Tablet orally administered under fasted conditions
15910729|NCT03567928|Device|Sedation with Gastro Cuff Pilot Laryngeal Mask|This specific type of laryngeal mask allows to separate the gastric and respiratory tract and allows the anesthesiologist to support patient's ventilation as (and only if) necessary.
15910730|NCT03567928|Drug|Propofol|Target controlled infusion (TCI) with propofol
15910731|NCT03567915|Other|Evaluation of gastric volume and content|The gastric volume and gastric content are assessed at 4, 5, 6, 7, and 8 hours after eating a meal.
15910732|NCT03567902|Device|C-MAC videolaryngoscope intubation|C-MAC videolaryngoscope intubation
15910733|NCT03567902|Device|Direct laryngoscope intubation|Direct laryngoscope intubation
15910734|NCT03567889|Drug|Daromun|Patients will receive intratumoral administrations into injectable cutaneous, subcutaneous, and nodal tumors of Daromun once weekly for up to 4 weeks. Surgery will follow within 4 weeks.
15910735|NCT03567889|Procedure|Surgery|Patients in Arm 2 will receive surgery within 4 weeks from randomisation.
15910736|NCT03567889|Drug|Adjuvant therapy|Patients will receive adjuvant therapy at the investigator's discretion following the surgery.
15910737|NCT03567876|Drug|Venetoclax|Consolidation and maintenance phases with Venetoclax (for a total of 2 years) after an induction phase R-BAC (up to 6 cycles for law risk patients and up to 4 cycles for high risk patients)
15910738|NCT03567863|Device|20-GAUGE PROCORE® first, then 22-GAUGE ACQUIRE®|The two punctures performed successively with the 20-GAUGE PROCORE® (COOK) and the 22-GAUGE ACQUIRE® (BOSTON SCIENTIFIC)
15910739|NCT03567863|Device|22-GAUGE ACQUIRE® first, then 20-GAUGE PROCORE®|The two punctures performed successively with the 22-GAUGE ACQUIRE® (BOSTON SCIENTIFIC) and the 20-GAUGE PROCORE® (COOK)
15910740|NCT03567850|Behavioral|Problem solving Skills Training|"Participants will be encouraged to identify specific problems particularly relevant to them and to their family's situation (instead of providing them with standardized examples) to be discussed and solved during the PSST sessions. The eight sessions of PSST will be organized in a systematized, therapeutic manner. Session 1 will be face-to-face and devoted to rapport building and understanding relevant social and medical information. The therapist (RA) will introduce PSST and the Bright IDEAS paradigm, present worksheets to guide PSST homework assignments, and give an overview of subsequent sessions. Starting at session 2, participants will continue training over the phone, with the same general structure and format. In sessions 2-7, the therapist and patient, with a supportive other (SO) if available, will review the patient's identified problems and work on application of problem-solving strategies and skills learned earlier."
15910741|NCT03567837|Other|Fructose + Glucose Beverage|The intervention is an oral sugar challenge with blood sampling over three hours.
15910742|NCT03567824|Drug|Magnesium L-lactate dihydrate|Magnesium L-lactate dihydrate 10 mEq extended release caplets
15910743|NCT03567824|Drug|Placebo Oral Tablet|Placebo will have the same appearance, taste, odor and mode of administration as MLD10.
15910744|NCT03567811|Procedure|Submaximal bicycle exercise stress test on Days 1 and 2|Identical submaximal stress tests were performed on both days to see if Day 1 exercise reduced performance on Day 2, or caused changes between BOLD scans during cognitive testing between Day 1 and Day 2.
15910745|NCT03567798|Dietary Supplement|UPLAT|Carica papaya leaf Extract + Tinospora cardifolia Extract
15910746|NCT03567798|Other|Placebo|Placebo
15910747|NCT03567772|Device|Wiifit Nintendo video game|
15910748|NCT03567772|Other|Pulmonary rehabilitation program|
15910749|NCT03567746|Procedure|Underwater EMR|Polypectomy is performed under full water emersion avoiding the use of submucosal injection.
15910750|NCT03567746|Procedure|Conventional EMR|It will be performed in a 2-step procedure. First the formation of a submucosal injection underneath the polyp to create a submucosal safety cushion. Then EMR is performed with a polipectomy snare.
15910751|NCT03567733|Device|XIENCE Sierra|Percutaneous coronary intervention
15910752|NCT03567720|Biological|tavokinogene telseplasmid|Intratumoral tavokinogene telseplasmid delivered by electroporation every 6 weeks
15910753|NCT03567720|Biological|Pembrolizumab|Intravenous 3 weekly treatments
15910754|NCT03567720|Device|Immunopulse|Device that administers electroporation
15910755|NCT03567720|Drug|nab paclitaxel|intravenous 4 weekly treatments
15910756|NCT03567707|Biological|C-section -Vaginal seeding|Mother-infant pair randomized to vaginal microbiota intervention. As soon as the infant is delivered, the infant will be brought to the neonate lamp, and unless the obstetrician or pediatric staff believes it is not in the best interest of the infant, s/he will be swabbed with the vaginal microbiota soaked gauze. Swabbing will take place ideally within 1 minute after delivery (but no longer than 5 minutes). The swabbing should take approximately 15 seconds. Infants will only undergo the seeding.
15910757|NCT03567707|Drug|C-section - Placebo Seeding|Mother-infant pair randomized to placebo microbiota intervention. As soon as the infant is delivered, the infant will be brought to the neonate lamp, and unless the obstetrician or pediatric staff believes it is not in the best interest of the infant, s/he will be swabbed with the placebo gauze. Swabbing will take place ideally within 1 minute after delivery (but no longer than 5 minutes). The swabbing should take approximately 15 seconds.
15910758|NCT03567707|Other|standard care|Mother-infant pair where mother undergoes spontaneous vaginal delivery, with both receiving standard of care.
15910759|NCT03567694|Drug|HA115|Test Drug
15910760|NCT03567694|Drug|Placebo|Placebo
15910761|NCT03567681|Drug|Extended release oxcarbazepine vs Immediate release oxcarbazepine|Extended release oxcarbazepine vs Immediate release oxcarbazepine
15910762|NCT03567668|Procedure|mitral valvuloplasty|Commissural plication was the most commonly used technique to repair mitral insufficiency, which was selectively supplemented by a specific combination of one or more of the following procedures: cleft closure, chordal shortening, transposition or replacement, edge-to-edge repair, leaflet augmentation, or division of papillary muscles, depending on the individual etiology and anatomy.
15910763|NCT03567655|Drug|Farlutal tab. 500mg/ Pfizer|Medroxyprogesterone Acetate
15910764|NCT03567642|Drug|Osimertinib|Osimertinib 80mg daily
15910765|NCT03567642|Drug|Platinum|Cisplatin 60mg/m2 or Cisplatin 45mg/m2 Carboplatin AUC 5 or Carboplatin AUC 4
15910766|NCT03567642|Drug|Etoposide|Etoposide 100mg/m2 or Etoposide 80mg/m2
15910767|NCT03567629|Drug|Irinotecan|Irinotecan 180 mg / m2, intravenous drip, D1, combined with fluorouracil / calcium folinate or Capecitabine or S1; combine or not combine with Bevacizumab or Cetuximab; every 14 days for a cycle.
15910768|NCT03567629|Drug|Oxaliplatin|Oxaliplatin 85mg/m2 (two-week regimen) or 130mg/m2 (three week regimen), intravenous drip, D1, combined with fluorouracil / calcium folinate or Capecitabine or S1; combine or not combine with Bevacizumab or Cetuximab; every 14 or 21 days for a cycle.
15910769|NCT03567616|Drug|Venetoclax|Tablet; oral
15910770|NCT03567616|Drug|Pomalidomide|Capsule; oral
15910771|NCT03567616|Drug|Dexamethasone|Administered orally; for participants over 75 years of age, dexamethasone could have been administered at a 20 mg dose [qw]
15910774|NCT03567577|Drug|Solnatide 25 mg powder for reconstitution for solution for inhalation|Inhalation of an aerosol every 12 hours (± 30 min), for a total of 7 days.
15940037|NCT03341299|Biological|Insulin Lispro|Administered SC
15910775|NCT03567577|Drug|0.9% Saline Solution|Inhalation of an aerosol every 12 hours (± 30 min), for a total of 7 days.
15910776|NCT03567564|Diagnostic Test|Abdominal muscles ultrasound|Abdominal muscles ultrasound during a spontaneous breathing trial using the M-mode to calculate the thickening fraction of the anterior and lateral abdominal muscles under multiple circumstances (tasks performed by the patients)
15910777|NCT03567551|Other|Women w/ Preeclampsia w/o Visual Disturbances or Headache|Up to three maternal blood samples collected from each participant, cerebrospinal fluid collected from each participant during spinal or combined spinal/epidural anesthesia, one umbilical cord blood sample obtained from each participant, four placenta samples obtained from each placenta from each participant
15910778|NCT03567551|Other|Women w/ Preeclampsia w/ Visual Disturbances or Headaches|Up to three maternal blood samples collected from each participant, cerebrospinal fluid collected from each participant during spinal or combined spinal/epidural anesthesia, one umbilical cord blood sample obtained from each participant, four placenta samples obtained from each placenta from each participant
15910779|NCT03567551|Other|Women w/o Preeclampsia|Up to three maternal blood samples collected from each participant, cerebrospinal fluid collected from each participant during spinal or combined spinal/epidural anesthesia, one umbilical cord blood sample obtained from each participant, four placenta samples obtained from each placenta from each participant
15910780|NCT03567538|Procedure|Thoracic surgery|Thoracic surgery, pulmonary resection, minimally invasive thoracic surgery, video assisted thoracic surgery (VATS)
15910781|NCT03567525|Procedure|lymph node dissection using the peritoneal iliac flap approach to seal lymphatic vessels|After pelvic lymph node dissection, lymphatic vessels will be sealed by formation of a peritoneal iliac flap in which the bladder in folded over the area of lymph node dissection
15910782|NCT03567525|Procedure|Standard surgical approach|After pelvic lymph node dissection, lymphatic vessels will be sealed using the standard approach
15910783|NCT03567512|Behavioral|Smoking hygiene intervention|The Smoking Hygiene Intervention(SHI) will be delivered in six different individualized counseling sessions (two in-person and four telephone counseling): the initial in-person counseling (30-45 minutes), 1 week telephone counseling (~20 minutes), 2 week telephone counseling (~20 minutes), 1 month in-person counseling (15-30 minutes), 2 month telephone counseling (~20 minutes), and 4 month telephone counseling (~20 minutes). The intervention, SHI, will address SHS exposure of children and parental quitting. It will include behavioral counseling to address health hazards of SHS for children, advice to quit smoking and to adopt a no smoking policy around children and self-help materials (related to second-hand smoking and quitting smoking).
15910784|NCT03567512|Behavioral|Placebo intervention|"The placebo intervention will include developmental perspective of the child at different stages of their life, advice on educational and emotional perspective of the child, discussion on the nutritional issues of the child, and self-help materials describing the child development issues.
~Subjects randomized to control group will receive a placebo intervention on child development issues delivered at six different individualized counseling sessions (two in-person and four telephone counseling): the initial in-person counseling (30-45 minutes), 1 week telephone counseling (~20 minutes), 2 week telephone counseling (~20 minutes), 1 month in-person counseling (15-30 minutes), 2 month telephone counseling (~20 minutes), and 4 month telephone counseling (~20 minutes)."
15910785|NCT03567499|Drug|GSK3039294|GSK3039294 capsules will be available with a dose strength of 100 mg and 200 mg to be taken as single or multiple capsules orally along with water depending on the dosage required.
15910786|NCT03567499|Drug|Placebo|Matching placebo capsules to match active 100 mg and 200 mg dose strength will be available and to be taken as single or multiple capsules orally along with water depending on the number of active capsules to blind.
15910787|NCT03567473|Drug|Oral dexamethasone|Two doses of oral dexamethasone, 0.6 mg/kg (maximum single dose 10 mg). One at the time of emergency department enrolment immediately prior to first nebulized treatment and one at approximately 24 hour later
15910788|NCT03567473|Drug|Nebulized Epinephrine|Two nebulized treatments of 3 mL 1:1000 epinephrine 30 minutes apart (+/- 15 minutes) at the time of emergency department enrolment
15910789|NCT03567473|Drug|Oral placebo|Two doses of oral placebo, 0.6 mL/kg (maximum single dose 10 mL). One at the time of emergency department enrolment immediately prior to nebulized treatment and one at approximately 24 hour later . Oral placebo at Canadian sites is composed of OraBlendTM and in New Zealand and Australian sites will be a compounded solution.
15910790|NCT03567473|Drug|Nebulized normal saline|Two nebulized treatments of 3 mL of normal saline 30 minutes apart (+/- 15 minutes) at the time of emergency department enrolment
15910791|NCT03567473|Drug|MDI Epinephrine|Two doses of Epinephrine given by MDI plus spacer at 625 mcg (5 actuations of 125mcg) 30 minutes apart (+/- 15 minutes) at the time of emergency department enrolment.
15910792|NCT03567473|Drug|MDI placebo|Two doses of inhaled placebo given by MDI plus spacer, 30 minutes apart (+/- 15 minutes) at the time of emergency department enrolment.
15910793|NCT03567460|Behavioral|Exercise|Across studies in adolescents in general population, 60 minutes of recommended daily exercise level is achieved, on average, within a total volume of 10,000-11,700 steps. The investigators will assess baseline physical activity quantitatively by using an accelerometer worn on the wrist during waking hours over a 7-day period. Each participant will be given a Garmin device to place on their wrist that will track their steps. Then patients will be asked to complete 10,000 steps daily for 6 months (acclimation over a week), which will be encouraged by daily text messages or e-mail, and weekly phone calls by the intervention team in addition to a Garmin and Facebook peer group.
15910794|NCT03567447|Drug|Droxidopa|starting with 100 mg TID and increasing in 100 mg TID increments, to a maximum of 600mg TID, to identify the highest tolerated dose for each patient.
15910795|NCT03567447|Other|Placebo|appearing to be 100 mg TID and increasing in 100 mg TID increments, to a maximum of 600mg TID, to identify the highest tolerated dose for each patient.
15910796|NCT03567434|Other|Alcohol vs. Placebo|Using a randomized, cross-over design, all subjects will consume evening alcohol (and a fluid-control placebo) in a dose that mimics binge drinking.
15910797|NCT03567408|Procedure|Selective PCI|Selective PCI for treatment of elderly patients (age≥65) presenting with diabetes mellitus.
15910798|NCT03567408|Drug|Bivalirudin|Before, during and after surgery, bivalirudin was used according to the dosage regimen to assess it's impact on elderly patients with diabetes mellitus undergoing selective PCI.
15940038|NCT03341286|Drug|TK3|Tryptophan and thiamine as on oral supplement
15910801|NCT03567382|Drug|Tenofovir Disoproxil Fumarate|300 mg tablet of TDF once daily from 28-32 weeks gestation through 12 weeks postpartum.
15910802|NCT03567382|Biological|Monovalent HBV vaccine|Infants born to HBsAg-positive women will be given a single dose of monovalent HBV vaccine within 24 hours of life.
15910803|NCT03567369|Drug|Dexamethasone|Dexamethasone 4,0 mg/mL
15910804|NCT03567369|Drug|Traumeel S|Traummel S 2,2 mg/mL
15910805|NCT03567356|Other|"MAT-PLUS Helping Hands"|"1) Significant other engagement through the Helping Hands approach empowers designated concerned helpers, providing concrete guidance for monitoring, supervision, and improving adherence for their loved one in treatment; 2) Care coordination and case management by counselors to enhance adherence to XRNTX ; 3) Assertive outreach incorporates frequent multi-channel outreach with the goal of achieving XRNTX dosing."
15910806|NCT03567343|Dietary Supplement|Proprietary Spearmint Extract Blend|Water extracted spearmint extract and green tea blend
15910807|NCT03567343|Other|Control|Placebo
15910808|NCT03567343|Dietary Supplement|Proprietary Blend And Melatonin|Water extracted spearmint extract and green tea blend and Melatonin (Proprietary Spearmint Extract Blend and Melatonin)
15910809|NCT03567343|Dietary Supplement|Melatonin|Melatonin Alone
15910810|NCT03567330|Behavioral|Family-based attachment-focused intervention|5 2-hour biweekly sessions involving parent and/or adolescent(s).
15910811|NCT03567330|Behavioral|Psychoeducation|Provides equivalent number of American Cancer Society psychoeducational sessions involving only parents.
15910812|NCT03567317|Device|CPAP withdrawal|Patients randomized to withdrawal will stop CPAP use for one week before study evaluations. Patients will also undergo a polysomnography to confirm the presence of severe OSA.
15910813|NCT03567304|Drug|Rilpivirine 25 mg|Rilpivirine 25 mg PO OD with meal (and continue 2 back bone of NRTIs)
15910814|NCT03567291|Drug|TEV-50717|6, 9, and 12 mg oral tablets
15910815|NCT03567291|Drug|Placebo|Placebo comparator
15910816|NCT03567278|Device|ACURATE TA™|ACURATE TA™ Transapical Aortic Bioprosthesis is intended for subjects with severe symptomatic Aortic Stenosis and are considered high risk for surgical conventional Aortic Valve Replacement surgery.
15910817|NCT03567252|Behavioral|Walking Group|Participants will walk 1 kilometer to a Farmer's Market.
15910818|NCT03567239|Device|Using adaptive device.|Participant uses the specially designed device for a specified length of time (no less than two days) and feedback is then gathered from the participant through questionnaires. These questionnaires include NASA-TLX, PIADS, QUEST, and a single question asking if the device improved their ability to address their specific need.
15910819|NCT03567226|Behavioral|WeChat Group|"Consenting participants will be randomized to either the intervention or the control arm after successfully wearing an accelerometer for one week. The WeChat Group will be a community forum to share information, encourage each other, and receive communications from the study team. In addition, the study team will disseminate the following information through the group:
~Daily/Weekly Reminders to exercise
~Health education materials regarding glaucoma and general health and exercise
~Motivational content
~Surveys to gauge what information participants found most interesting and useful to help them exercise"
15910820|NCT03567226|Behavioral|Counselling|Study participants in the control group will receive a handout telling them to increase walking and will be counseled that walking may be helpful for the eye at the return visit
15910822|NCT03567200|Behavioral|Single-Arm Feasibility|Participants in each of the 8 participating groups (N=10-12 per group) are exposed to an integrated intervention program (integration of physical activity and psychosocial components). Each session is co-facilitated by a trained research staff member and a registered social worker, providing participants with the opportunity to engage in physical activity behaviours as well as discuss various psychosocial topics that are applicable to the participants interests. Physical activities include participating in group activities such as rock climbing, self-defence, yoga, etc. Psychosocial topics addressed include group discussions around cyber-bullying, sexual abuse and exploitation, gender issues, etc.
15910823|NCT03567187|Device|iovera|The iovera° device is 510(k)-cleared (K133453 and K161835) and is used to form a precisely controlled, sub-dermal cold zone of -20 to -88.5 degrees Celsius to temporarily disrupt peripheral nerve function, ultimately blocking pain. It is not indicated for the treatment of central nervous system tissue.
15910824|NCT03567174|Other|Integrated care van (ICV)|Structural service delivery intervention
15910825|NCT03567161|Procedure|Cavitron ultrasonic surgical aspirator|"Cavitron Ultrasonic Surgical Aspirator (CUSA) has proven to be effective in biofilm disruption and cell stimulation . The hypothesis is that the employment of CUSA for non-surgical treatment of infrabony defects thanks to its abilities to disrupt, fragment and aspirate granulation tissue, will allow the formation of larger and more stable blood clot.
~According to the anatomy of the osseous sites, the sonotrode (Sonocare 300 by Söring GmbH, Justus-von-Liebig-Ring 2 -25451 Quickborn Germany) will be inserted both intrasulcularly and trans gingivally (smallest tip is 0,8 mm); intrasulcularly in the cases of three wall defects, and trans gingivally in cases of one to two wall defects ."
15910826|NCT03567148|Procedure|PRF|Applying to the palatal wounds
15910827|NCT03567148|Procedure|Essix retainer|Applying to the palatal wounds
15910828|NCT03567148|Procedure|Ozone therapy|Applying to the palatal wounds
15910829|NCT03567148|Procedure|LLLT|Applying to the palatal wounds
15910830|NCT03567148|Procedure|Collagen fleece|Applying to the palatal wounds
15910831|NCT03567135|Drug|Apatinib|These drugs are planned to inhibit the proliferation and metastasis of tumors.
15910832|NCT03567135|Drug|Temozolomide（TMZ）|Radiotherapy is a common treatment for glioblastoma.Accompanied with TMZ, the damages caused by tumors to the normal tissues will be reduced.
15910833|NCT03567122|Other|Internal Focus of Attention|Information already included in arm/group descriptions.
15910834|NCT03567122|Other|External Focus of Attention|Information already included in arm/group descriptions.
15910835|NCT03567122|Other|Control|Information already included in arm/group descriptions.
15910836|NCT03567109|Other|hand laterality judgment task|participants are asked to identify laterality of the hand presented on the screen
15910908|NCT03566511|Drug|Placebo|Healthy and T2D participants will receive placebo between baseline MRI scan and second MRI scan.
15910837|NCT03567096|Device|BiV pacing with MPP and SyncAV|This cohort will receive Bi-Ventricular Pacing (left ventricle and right ventricle pacing) with MultiPoint Pacing of the left ventricle (two stimulation sites) and the SyncAV algorithm active.
15910838|NCT03567096|Device|LV only pacing with MPP and SyncAV|This cohort will receive left ventricular only pacing (no right ventricle pacing) with MultiPoint Pacing of the left ventricle (two stimulation sites) and the SyncAV algorithm active.
15910839|NCT03567083|Behavioral|Problem Management Plus (PM+)|This intervention is based on the WHO treatment guidelines for conditions related to stress (WHO, 2013). It is a 5-session intervention that is delivered by trained non-specialized workers or lay people, and is available in individual and group delivery formats for both children and adults. PM+ includes evidence-based techniques such as; problem solving, stress management, behavioral activation, and accessing social support. It has proved to be effective by two randomized controlled trials (RCTs) in Kenya and Pakistan (Bryant, Dawson, Schafer, Sijbrandij, & van Ommeren, 2016; Rahman, Hamdani, Awan, Bryant, Dawson, Khan, Mukhtar-ul-Haq Azeemi, et al., 2016).
15910840|NCT03567070|Other|qualitative study based on an individual clinical interview|qualitative study based on an individual clinical interview
15910841|NCT03567057|Drug|ADS-5102|Oral capsules to be administered once daily at bedtime for the 52-week open-label treatment period.
15910842|NCT03567044|Diagnostic Test|Blood Draw|Eligible subjects will have blood draws at the following times: baseline, 1 week, 4 weeks, 8 weeks, 12 weeks, 24 weeks.
15910843|NCT03567031|Procedure|EtCO2 modification|Controlled modification of EtCO2 through modification of ventilation parameters under general anesthesia without spontaneous breathing
15910844|NCT03567018|Device|MRI Scan|Study participants will be scanned with a 3.0 Tesla Phillips Ingenia CX whole body clinical MRI system located at the Wright Center of Innovation at The Ohio State University Medical Center. Anatomical and angiographic MR images will be acquired for one of the most commonly used flap surgery donor perforators including but not limited to: the deep inferior epigastric perforators (DIEP); the superior gluteal arter perforators (SGAP); the inferior gluteal artery perforators (IGAP); the thoracodorsal artery perforators (TDAP); the anterolateral thigh perforators (ATL).
15910845|NCT03567005|Device|Nelfilcon A digital contact lenses|Silicone hydrogel digital contact lenses
15910846|NCT03567005|Device|Nelfilcon A contact lenses|Silicone hydrogel spherical contact lenses
15910847|NCT03566992|Procedure|Gastric|Placement of a nasoenteric tube
15910848|NCT03566979|Drug|Test naproxen sodium tablet|Single dose of 2 test naproxen sodium 220 mg tablets
15910849|NCT03566979|Drug|Commercial naproxen sodium tablet|Single dose of 2 naproxen sodium 220 mg tablets
15910850|NCT03566979|Drug|Commercial naproxen sodium liquid gels capsule|Single dose of 2 naproxen sodium 220 mg liquid gel capsules
15910851|NCT03566979|Drug|Placebo tablet|2 placebo tablets
15910852|NCT03566966|Biological|Non-organ-specific Ab positive|Antiviral administration and evaluation of SVR24 and side effects
15910853|NCT03566966|Biological|Non-organ-specific Ab negative|direct-acting antiviral agents
15910854|NCT03566940|Biological|sIPV|Participants will receive 0.5 milliliter (mL) of sIPV as a solution for IM injection.
15910855|NCT03566940|Biological|cIPV|Participants will receive 0.5 mL of cIPV as a suspension for IM injection.
15910856|NCT03566927|Combination Product|FLEX Scoring Catheter with Lutonix DCB|Treatment by the FLEX Scoring Catheter, a plain balloon angioplasty, followed by a Lutonix DCB.
15910857|NCT03566914|Drug|Tadalafil 10 MG|Tadalafil 10 mg per oral once daily for 3 months
15910858|NCT03566914|Other|Placebo|TPlacebo tablet per oral once daily for 3 months
15910859|NCT03566901|Device|G-EO System|The G-EO Systems can reproduce the gait pattern and realistically simulates the ability to carry out stairs up and stairs down. It provides real-time feedback on the patient's movements with the Visual Scenario and offers the possibility to experience augmented reality further enhance the effectiveness of each therapy session. An intelligent control (G-EO System Evolution) reacts and adapts to each patient's individual capability by either supporting the patient - active assistive mode - or increasing resistance - active mode. The G-EO Systems rehabilitation robot allows to secure the subjects with a harness while they stood on the foot plates of the machine. The foot plates has 3 DoF each, allowing to control the length and the height of the steps and the foot plate angles. The maximum step length corresponded to 550 mm, the maximum achievable height of the steps is 400 mm, the maximum angles is ±90°. The maximum speed of the foot plates is 2,3 km/h.
15910860|NCT03566901|Other|Conventional Physiotherapy|Overground walking training including real stair climbing up/down and lower limb mobilization and stretching exercises.
15910861|NCT03566888|Device|Blood pressure assessment|Validation of an automated blood pressure device
15910862|NCT03566875|Procedure|Total knee arthroplasty with the Stryker's MAKO™ system|The robot assisted surgery is performed using the Stryker's MAKO™ system. The precision with this system is very accurate. It should help the surgeon to improve the positioning accuracy of prosthetic implants compared to the conventional method.
15910863|NCT03566875|Procedure|Total knee arthroplasty with mechanical ancillary|The arthroplasty is performed with the mechanical ancillary refering to the the conventional method.
15910864|NCT03566862|Diagnostic Test|Leicester Cough Monitor (LCM)|The Leicester Monitoring Cough (LCM) kit includes a digital flash voice recorder (Sony ICD-PX333), aA clip-on lapel microphone (Philips LFH9173) and a small carry/travel waist bag.
15910865|NCT03566849|Other|KC group|"1st week: each 10 rep/set, 3 set/day. PNF scapular pattern: posterior depression (Combination of isotonic, COI), Ball modified prone Cobra, Ball prone V-raise, Ball prone row, Ball side plank, Ball one-leg bridging
~2nd week: each 10 rep/set, 3 set/day. Half sit-up with rotation to left/right, Side plank with ER, Prone extension with rotation to left/right, Bilateral one-leg squat with flexion, Squat to row
~3rd week: 5 rep/set, 3 set/day (sling exercise). Prone shoulder protraction, Supine shoulder retraction, Side-lying hip ABD/ADD, Supine pelvic lift, Prone bridging
~4th week: each 10 rep/set, 3 set/day. Lateral lunges with shoulder ABD/ER, Lunge with trunk rotation, Forward punch plus with serape effect, Spiking exercise, One-quarter vertical squat jump"
15910906|NCT03566524|Dietary Supplement|Alanine|Ketosis prone diabetes patients (n=13) will be randomly assigned to receive dietary supplements of alanine as placebo
15910907|NCT03566511|Drug|Diazoxide|Healthy and T2D participants will receive diazoxide at a dose of 4-7 mg/kg (based upon weight) between baseline MRI scan and second MRI scan.
15911071|NCT03565367|Procedure|Magnetic Resonance Spectroscopic Imaging|Undergo MRSI
15910866|NCT03566849|Other|CT group|"1st week: each 10 rep/set, 3 set/day. PNF scapular pattern: posterior depression (Combination of isotonic, COI), Knee push up plus, Modified prone Cobra, Prone V-raise, Prone row, Side-lying ER
~2nd week: each 10 rep/set, 3 set/day. Supine punch, Prone horizontal ABD, Prone V-raise, Prone row, Side-lying ER
~3rd week: each 10 rep/set, 3 set/day. Sitting chest press, Sitting ABD in scaption, Sitting overhead press, Long-sitting resisted extension, Sitting ER
~4th week: each 10 rep/set, 3 set/day. Standing horizontal pull-apart, Standing retraction plus ER, Standing resisted extension, Ball pushed on wall and controlled rolling, Wall push-up"
15910867|NCT03566836|Device|Garmin Smart Watch|Garmin Smart Watch
15910868|NCT03566836|Device|Garmin Chest Band|Garmin Chest Band
15910869|NCT03566823|Biological|Ontamalimab|Subcutaneous injection of ontamalimab will be administered using a prefilled syringe.
15910870|NCT03566823|Other|Placebo|Subcutaneous injection of placebo matched with ontamalimab will be administered using a prefilled syringe.
15910871|NCT03566810|Drug|Test GXR|Participants received a single oral dose of 500 mg of test GXR tablet (Merck Nantong/China) under fasting or fed conditions on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2).
15910872|NCT03566810|Drug|Reference GXR|Participants received a single oral dose of 500 mg of reference GXR tablet (Merck Darmstadt/France) under fasting or fed conditions on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2).
15910873|NCT03566784|Procedure|Inguinal hernia repair|Standard procedure for inguinal hernia repair
15910874|NCT03566771|Behavioral|Usual care|The child and parent(s) at regular visits to the pediatric clinic for childhood obesity treatment
15910875|NCT03566771|Behavioral|CLOSS|Usual care plus using mobile applications to register weight and physical activity as well as for communication with the clinic. A web-based support system enables health care professionals to follow the patient's daily objectively measured weight and physical activity online.
15910876|NCT03566745|Diagnostic Test|Blood for protein activity|Blood for protein activity
15910877|NCT03566719|Other|Exercise program|Intervention group has been submitted to an exercise program directed to prevent and reduce fall risk
15910878|NCT03566706|Behavioral|Discussion Tool: Unhealthy Eating|Parents will randomly be assigned to one of three discussion tools that will provide parents with tools on how to communicate with their children about unhealthy eating, marijuana use, or sedentary behavior.
15910879|NCT03566706|Behavioral|Discussion Tool: Marijuana Use|Parent Discussion Tools
15910880|NCT03566706|Behavioral|Discussion Tool: Sedentary Behavior|Parent Discussion Tools
15910881|NCT03566693|Device|Dexcom G6 CGM System|continuous glucose monitor
15910882|NCT03566693|Device|Blood glucose meter|Blue-tooth enabled blood glucose meter
15910883|NCT03566680|Device|Orthokeratology|Orthokeratology is a type of contact lens that is worn over night to reduce refractive error, so patients do not need to wear vision correction during the day.
15910884|NCT03566667|Drug|Metoprolol|Betablocker
15910885|NCT03566667|Drug|Standard care|Standard care
15910886|NCT03566654|Device|remote ischemic conditioning|RIC is a physical strategy performed by an electric autocontrol device with cuffs placed on unilateral arms and inflated to 200 mmHg for 5-min followed by deflation for 5-min, the procedures is performed repeately for 5 times， two times per day. The duration of the treatment is 30+/-2days.
15910887|NCT03566654|Device|ambulatory blood pressure monitoring|A diagnostic technique for measuring blood pressure in daily life by means of automatic intermittent timing. Because ABPM has overcome the limitations of clinic blood pressure measurement, observation error and white coat effect, it can objectively reflect the actual level and fluctuation of blood pressure. Each patient of the two arms will use ABPM measure blood pressure before and after RIC or sham RIC treatment.
15910888|NCT03566654|Device|Sham remote ischemic conditioning|Sham RIC is a physical strategy performed by an electric autocontrol device with cuffs placed on unilateral arms and inflated to 60 mmHg for 5-min followed by deflation for 5-min, the procedures is performed repeately for 5 times. The duration of the treatment is 30+/-2days.
15910889|NCT03566641|Device|Negative pressure wound therapy|The application of a vacuum across the surface of a wound through a foam dressing cut to fit the wound.
15910890|NCT03566641|Other|standard care dressing|The application of a standard care dressing (instead of negative pressure wound therapy) across the surface of wound.
15910891|NCT03566628|Other|Warmed Isotonic Saline|Isotonic saline warmed to 39ºC.
15910892|NCT03566628|Other|Room-Temperature Isotonic Saline|Isotonic saline at room temperature
15910893|NCT03566615|Device|CAP-straight|This study is to detect any differences in the detection rate of adenomas using straight caps that will be attached to the colonoscope and to compare it to the control method where no cap is used in the colonoscopy procedure.
15910894|NCT03566615|Device|CAP-daisy|This study is to detect any differences in the detection rate of adenomas using daisy caps that will be attached to the colonoscope and to compare it to the control method where no cap is used in the colonoscopy procedure.
15910895|NCT03566615|Other|water|using water instead of traditional air insufflation to help insertion
15910896|NCT03566602|Device|Dura Sealant Patch|Adjunctive bioresorbable patch
15910897|NCT03566589|Dietary Supplement|Lactobacillus plantarum PS128|daily ingestion of 60 billion colony forming unit (CFU) of Lactobacillus plantarum PS128 (30 billion CFU/capsule)
15910898|NCT03566576|Drug|Anlotinib|Anlotinib 8mg p.o. qd in first cohort (3 subjects). 10mg p.o. qd in second cohort (3 subjects). 12mg p.o. qd in third cohort (3 subjects).
15910899|NCT03566576|Drug|Pemetrexed|Pemetrexed 500mg/m2 as a 10-minute intravenous infusion on day 1 of a 21-day cycle.
15910900|NCT03566576|Drug|Docetaxel|Docetaxel 60mg/m2 as a 10-minute intravenous infusion on day 1 of a 21-day cycle.
15910901|NCT03566563|Other|Screening|Patients tested positive for Hepatitis C will be referred to Hospital through the conventional health care services and by an alternative direct access method to determine if this improves linkage to care
15910902|NCT03566550|Diagnostic Test|MRI scans|Repeated MRI scans imaging digestion of standard meals
15910903|NCT03566537|Procedure|Thyroidectomy|Thyroidectomy
15910904|NCT03566524|Dietary Supplement|arginine|Ketosis prone diabetes patients (n=13) will be randomly assigned to receive dietary supplements of arginine
15910905|NCT03566524|Dietary Supplement|Citrulline|Ketosis prone diabetes patients (n=13) will be randomly assigned to receive dietary supplements of citrulline
15910909|NCT03566498|Dietary Supplement|Immediate hydration|They will be allowed to start oral fluids immediately (within the first 2 hours post operatively) beginning with water or clear fluids (but not milk or soda containing drinks), the amounts will be according to their needs, solid food will be given gradually after tolerating the drinks and intravenous fluids will be given beside all of that and till the return of intestinal movements
15910910|NCT03566498|Dietary Supplement|Early hydration|They will receive the routine intravenous fluids and the oral fluids will be given after 8 hours post operatively and gradually, solid food will be allowed after that gradually too and the intravenous fluids will be stopped after return of intestinal movements.
15910911|NCT03566485|Drug|Atezolizumab|Given by IV
15910912|NCT03566485|Drug|Cobimetinib|Given by mouth
15910913|NCT03566485|Drug|Idasanutlin|Given by mouth
15910914|NCT03566472|Diagnostic Test|Continuous Glucose Monitoring System|Continuous Glucose Monitoring System for 72 hours
15910915|NCT03566459|Other|CBOC offering Tele-MOUD to Veterans|CBOC offering medications for opioid use disorder (MOUD) using telemedicine
15910916|NCT03566459|Other|CBOC not offering Tele-MOUD to Veterans|CBOC not offering medications for opioid use disorder (MOUD) using telemedicine
15910917|NCT03566446|Biological|CALRLong36 peptide|200 ug CALRLong36 peptide in water mixed with 500ul montanide
15910918|NCT03566433|Procedure|Tep surgery for inguinal hernia|TEP surgery
15910919|NCT03566433|Procedure|Lichtenstein|Lichtenstein surgery for inguinal hernia
15910920|NCT03566407|Procedure|Colonoscopy|Colonoscopy will be required for all subjects at 6 months - Visit 3.
15910921|NCT03566394|Drug|Gabapentin 300mg|Gabapentin 300mg orally three times a day, from 2 days before to 5 days after taxane infusion
15910922|NCT03566381|Device|Application of a soft patch composed of medical-grade silicone that collects sweat during a subject's natural behaviors.|This device contains sweat sensors embedded in an elastomer and is applied to the skin with a medical grade adhesive.
15910923|NCT03566368|Diagnostic Test|Electrocardiogram|a 12 lead surface electrocardiogram taken after connecting limb and chest electrodes
15910924|NCT03566368|Diagnostic Test|Transthoracic Echocardiogram|Transthoracic echocardiogram performed to evaluate Cardiac function in parasternal - long and short axis, Apical - 4 chamber and 5 chamber views.
15910925|NCT03566368|Diagnostic Test|Cardiac enzyme - Troponin I Levels|Blood sample - venous collected to measure blood troponin - I levels.
15910926|NCT03566355|Radiation|curative proton therapy|Patients who meet the selection criteria are selected, signed for consent, and treated with proton therapy alone at 7200 cGy / 15 fractions, 5 times a week for 3 weeks
15910927|NCT03566329|Drug|Magnesium sulphate|Magnesium sulphate 50 mg/kg over 10 minutes loading followed by 15mg/kg/hr infusion. .
15910928|NCT03566329|Drug|Lidocaine Hydrochloride|lidocaine hydrochloride 1.5mg/kg loading followed by 2mg/kg/hr infusion
15910929|NCT03566329|Drug|Normal saline|Normal saline infusion with the same rate of infusion as the study drugs
15910930|NCT03566316|Drug|Telmisartan/Amlodipine|
15910931|NCT03566316|Drug|Rosuvastatin|
15910932|NCT03566316|Drug|Telmisartan|
15910933|NCT03566303|Drug|Rivaroxaban 15 mg|Rivaroxaban 15 mg BID
15910934|NCT03566303|Drug|Warfarin|Warfarin
15910935|NCT03566290|Drug|GTx-024|Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024. Subjects will be required to take one 3 mg Softgel capsule per day.
15910936|NCT03566277|Behavioral|Self-monitoring|Participants will have access to a wrist-worn activity monitor and have a daily step goal
15910937|NCT03566277|Behavioral|Incentives|Participants will have a deposit contract, wherein they will lose money if a goal is not reached, or double their money if a goal is reached
15910938|NCT03566277|Behavioral|Feedback|Participants will receive text message feedback each day about progress towards their goal
15910939|NCT03566264|Other|Non-Interventional|Non-Interventional
15910940|NCT03566251|Other|Balance|Balance was assessed by Biodex Biosway Portable Balance System (Biodex Medical Systems Inc., Shirley, New York). Postural Stability (PS), Limits of Stability (LOS) and Modified Sensory Organization Tests (MSOT) were evaluated with this system. PS test assesses static balance during standing up by the ability to hold the center of gravity on the support surface. The test was performed on both feet and on the left and right foot separately. LOS test assesses how much the center of gravity is displaced on the support surface without losing balance during the standing position. MSOT assesses the effects of somatosensory, visual and vestibular senses on postural control during the standing position. It evaluates the sensory component of balance in two different visual conditions and on two different support surfaces.
15910941|NCT03566251|Other|Functional mobility|Timed Up and Go (TUG) tests were used to evaluate functional mobility. The TUG measures the time it takes a subject to stand up from an armchair, walk a distance of 3 m, turn, walk back to the chair and sit down. Time was recorded in seconds with a stopwatch.
15910942|NCT03566251|Other|Core stability|Core endurance and core strength, which are two specific components of core stability, were evaluated separately. Trunk flexor, trunk extensor, right and left side bridge and prone bridge tests were applied to assess the endurance of the core muscles. Tests were terminated when the subjects said they could not continue the test or when the test position was broken. A stopwatch was used for the measurements and the results were recorded in seconds. The power of core muscles was evaluated with sit-ups and modified push-ups tests. It was recorded how many times the subject could do each test for 30 seconds. The tests were repeated twice and the best measurement score was recorded for use in the statistical analyses.
15910943|NCT03566251|Other|Trunk position sense|Trunk position sense was evaluated by the trunk reposition test with Dualer IQ digital inclinometer (J-TECH medical, Salt Lake City, UK, USA). Measurements were made in two levels: lumbosacral (LS) and thoracosacral (TS) regions. The testing took place while standing under three visual-surface conditions. Participants flexed the trunk approximately 30° in the sagittal plane, holding the position for a count of 3 seconds (position 1) and then participants attempted to repeat the previously attained angle. Participants indicated verbally when they felt they had reached the angle and held their position for a count of 3 seconds (position 2). The absolute difference in degrees between positions 1 and 2 was defined as the trunk reposition error (TRE) degree. Participants generated five scores for each visual-surface condition. For each condition, the highest and lowest scores were discarded and the mean of the remaining three scores represented the TRE score
15911211|NCT03564353|Device|tDCS|tDCS
15910944|NCT03566238|Drug|A4250 (odevixibat)|A4250 is a small molecule and selective inhibitor of ileal bile acid transporter (IBAT).
15910945|NCT03566238|Drug|Placebo|Placebo identical in appearance to active drug (A4250).
15910946|NCT03566225|Drug|Pioglitazone|Insulin sensitizing agents
15910947|NCT03566225|Drug|Metformin|Insulin sensitizing agent
15910948|NCT03566225|Drug|Clomiphene Citrate|Induction drug
15910949|NCT03566212|Device|Conventional Syringe|local anesthesia was administered in first group using Conventional syringe
15910950|NCT03566212|Device|Camouflage Syringe|local anesthesia was administered in second group using Camouflage syringe
15910951|NCT03566199|Drug|Panobinostat Nanoparticle Formulation MTX110|Given IT
15910952|NCT03566199|Drug|Convection-Enhanced Delivery (CED)|Undergo CED
15910953|NCT03566186|Other|Phototherapy|Photobiomodulation or photobiostimulation, this technique is the application of monochromatic light that can influence cellular activity through inhibition or stimulation of chemical and biological functions.
15910954|NCT03566186|Other|Placebo|The same procedures as in the active phototherapy group was applied to the placebo group; however, the emitter was disabled. The device was emit the same sounds regardless of the programmed mode (active phototherapy).
15910955|NCT03566186|Other|Passive recovery|Participants was remain sat for passive recovery supervised by an independent therapist during the period when the other groups are received recovery strategies.
15910956|NCT03566160|Device|Cryobiopsy probe, administered to study participants|Cryobiopsy probe as a tool for gastrointestinal biopsy
15910957|NCT03566147|Biological|Human primary Retinal Pigment Epithelial (HuRPE) cells|HuRPE will be transplanted by a board-certified vitreoretinal surgeon, which will be administered into the subretinal space of experimental eye through a standard surgical approach.
15910958|NCT03566134|Drug|DA-8010 Placebo|Participants receive placebo to match DA-8010 orally once a day.
15910959|NCT03566134|Drug|DA-8010 2.5mg|Participants receive DA-8010 2.5mg orally once a day.
15910960|NCT03566134|Drug|DA-8010 5mg|Participants receive DA-8010 5mg orally once a day.
15910961|NCT03566134|Drug|Solifenacin 5mg|Participants receive solifenacin 5 mg orally once a day.
15910962|NCT03566134|Drug|Solifenacin succinate placebo|Participants receive placebo to match solifenacin 5 mg orally once a day.
15910963|NCT03566121|Other|Pelvic ultrasound / Urodynamic ultrasound|Gynecological consultation: calculating the score ICI-Q Ultrasound consultation: pelvic ultrasound Urodynamic ultrasound during a Valsalva manoeuvers
15910964|NCT03566108|Procedure|VISTA|Vestibular incision supraperiosteal tunnel access (VISTA) incision will be performed on all individuals in this arm of the study to facilitate coronal advancement of the gingival flap and placement of acellular dermal matrix
15910965|NCT03566108|Procedure|STA|Sulcular tunnel access incision will be performed on all individuals in this arm of the study to facilitate coronal advancement of the gingival flap and placement of acellular dermal matrix
15910966|NCT03566095|Behavioral|Coaching and Voices for Food Kit|Community Coaching and Voices for Food Kit
15910967|NCT03566095|Behavioral|Voices for Food Kit|Voices for Food Kit
15910968|NCT03566069|Drug|Intranasal Oxytocin|32IU (16IU*2) of OT, Sorbitol, Benzyl, alcohol glycerol, distilled water.
15910969|NCT03566069|Other|Intranasal Placebo|32IU (16IU*2) of Sorbitol, Benzyl, alcohol glycerol.
15910970|NCT03566056|Other|Complications to Whipples procedure|Patients undergoing the Whipple procedure often tend to have a lot of complications. This study aims to investigate what complications these patients experience
15910972|NCT03566030|Drug|Tenofovir disoproxil fumarate 300mg|Administered Tenofovir disoproxil fumarate 300 mg QD
15910973|NCT03566030|Drug|Tenofovir Alafenamide 25 mg|Administered Tenofovir Alafenamide 25 mg QD
15910974|NCT03566017|Biological|pegunigalsidase alfa|Recombinant human alpha galactosidase A
15910975|NCT03566004|Diagnostic Test|Stool specimen collection|The stool specimen collection was performed at the hospital or at home using a disposable device to be placed on the toilet seat and an E-nat Tube sent by postal to the lab.
15910976|NCT03565991|Drug|Avelumab|IV treatment
15910977|NCT03565991|Drug|Talazoparib|Oral treatment
15910978|NCT03565978|Device|BAMA solution|Use of BAMA cardiac post-discharge management solution for patients education and follow up management
15910979|NCT03565965|Behavioral|Experimental training|"Each block of MP consists of 5 mental walking attempts with 10 imagined steps. Participants, seated comfortably, eyes closed, will be asked to imagine themselves walking as of a first-person perspective, without any overt physical movement, in four different conditions: habitual speed, as fast as possible, overcoming obstacles and memorizing a name of a specific medication.
~Each block of PP consists of 5 physical walking attempts, with 10 steps. Participants will be asked to walk in 4 different conditions: habitual speed,as fast as possible, overcoming obstacles and memorizing a name of a specific medication."
15910980|NCT03565965|Behavioral|Control training|"Each block of MP consists of 5 mental walking attempts with 10 imagined steps. Participants, seated comfortably, eyes closed, will be asked to imagine themselves seated appreciating a beautiful landscape as of a first-person perspective, without any overt physical movement, in four different contexts: in a carriage, in a hot air balloon, in a boat and in a zepelin.
~Each block of PP consists of 5 physical walking attempts, with 10 steps. Participants will be asked to walk in 4 different conditions: habitual speed,as fast as possible, overcoming obstacles and memorizing a name of a specific medication."
15910981|NCT03565952|Other|Cranial massage|Manual cranial therapy consisting of massage and cranial relaxing techniques, lasting 30 minutes each session approximately, for 3 weeks and one month follow-up. Manual therapy consists of a prone and supine cranial massage.
15910982|NCT03565952|Other|Control group|The control group does not receive treatment
15910983|NCT03565939|Biological|Trichuris suis ova|Eggs from the pig whipworm
15910984|NCT03565939|Biological|Placebo|Solution without TSO
15910985|NCT03565926|Other|Manual Therapy|"Articulation technique L4-S1
~Lumbar neuromuscular technique
~Fascial technique of crossed hands
~Posteroanterior mobilizations of the lumbar vertebrae"
15910986|NCT03565926|Other|Hypopressive exercises|Protocol 5 Hypopressive exercises
15911015|NCT03565705|Procedure|Open abdominal prostatectomy|Patients undergo standardized open abdominal prostatectomy.
15910987|NCT03565913|Drug|EffCaMgCit|Patients in the EffCaMgCit group will receive 45 meq (900 mg) Ca, 30 meq (365 mg) Mg, and 135 meq total citrate per day from 3 months to 2 years.
15910988|NCT03565913|Other|CaAcS|CaAcS group will take 45 meq (900 mg) Ca and 45 meq acetate (without Mg or citrate), three times daily for 2 years
15910989|NCT03565900|Biological|V114|15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose.
15910990|NCT03565900|Biological|Prevnar 13™|13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg), and aluminum phosphate adjuvant (125 mcg aluminum) in each 0.5 ml dose
15910991|NCT03565900|Biological|PNEUMOVAX™23|23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose
15910992|NCT03565887|Drug|RVL-1201|RVL-1201 ophthalmic solution 0.1%
15910993|NCT03565887|Other|Vehicle ophthalmic solution|Vehicle placebo ophthalmic solution
15910994|NCT03565874|Device|Heart rate variability biofeedback|Before the start of the program and after one week of adherence to the program, two sessions will be conducted with a psychologist in order to define each participant's individual resonance frequency (i.e., breathing rhythm allowing for cardiac coherence), using the Nexus program from Mindmedia company. Then, each participant will receive training on the HRVB program using an Emwave device. The HRVB program itself will be carried individually for 20 min daily over the course of two weeks. Five daily sessions of 10 minutes will be considered as the minimum adherence to the program. Each participant will be asked to report in a diary all eventual major stressful life events.
15910995|NCT03565861|Drug|Placebo|Intravenous vehicle
15910996|NCT03565861|Drug|NP10679|NP10679
15910997|NCT03565848|Procedure|Mesenteric vascular and nerve sparing surgery in laparoscopic segmental colorectal resection|Laparoscopic segmental colorectal resection performed by dissecting adherent to the intestinal wall with mesenteric vascularization and innervation entirely preserved.
15910998|NCT03565835|Drug|Abiraterone Acetate|Abiraterone Acectate with Prednisone and with Discontinuation of GnRH Analogue
15910999|NCT03565835|Drug|Prednisone|Abiraterone Acectate with Prednisone and with Discontinuation of GnRH Analogue
15911000|NCT03565822|Other|Interview|individual interview and/or focus group Grounded theory qualitative analysis of data related to socio-demographic and child characteristics data First, data will be prepared for qualitative analysis. Digital audio files from the focus groups will be transcribed verbatim and questionnaire data will be entered into an Excel/word data file. Second, focus group data will be qualitatively analyzed using the constant comparative process. A qualitative data analysis program, NVivo11 (Victoria, Australia/ QSR International)) will be used to assist with this coding process.
15911001|NCT03565809|Other|Incidence analysis|Incidence analysis between the 2 groups (ADRS/non ADRS). For each pair, an index date was defined as the ADRS identification date. In both groups, a 5-year period free of these three ADRS criteria was required before the index date, to ensure incident ADRS cases.
15911002|NCT03565796|Behavioral|Personalized active referral plus financial incentive|Smokers will be introduced to various SC services in Hong Kong and be motivated to use the services.Written consents will be obtained from smokers who are ready to book the service onsite for transfer of their contact telephone numbers to their chosen service providers. Our research staff will transfer the information to the service providers within a week since the enrollment.Smokers are informed at baseline that they will receive financial incentive (supermarket coupon HK$300) if they attend or use any of the SC services within 3-month.
15911003|NCT03565796|Behavioral|AWARD advice|Ask about smoking history, Warn about the high risk of smoking, Advise to quit as soon as possible, Refer to the smoking cessation services, and Do it again (if the smokers refused to set quit date).
15911004|NCT03565796|Behavioral|Warning leaflet|The 2-sided color printed A4 leaflet, which systematically covers the most important messages to motivate smoking cessation
15911005|NCT03565796|Behavioral|Referral card|"The 3-folded Smoking Cessation Services card consists of brief information and highlights of existing smoking cessation services, contact methods, motivation information and strong supporting messages or slogans"
15911006|NCT03565796|Behavioral|COSH booklet|A general smoking cessation self-help booklet
15911007|NCT03565783|Biological|Cemiplimab|Given IV
15911008|NCT03565770|Other|individual coaching|coaching on the phone or with messages on line twice a month in order to help patients to adjust their insulin doses and fill in their self-assessment test.
15911009|NCT03565770|Other|Standard care|completion of the self-assessment test at inclusion, at M6 and M12 for all study participants
15911010|NCT03565757|Behavioral|SMART intervention|All participants will attend a 90-minute SMART small group session. This session provides education on the stress response and the principles of gratitude, compassion, mindful presence, and resilient mindset. In addition to the class, there will be follow-up online and written resources.
15911011|NCT03565744|Behavioral|B'N Fit POWER|Participants will undergo a medical assessment and using an Electronic Medical Record (EMR) template, providers will screen for a healthy weight and the 7 target behaviors. Participants will set goals with the provider to attain one of the target behaviors and will receive an EMR-generated treatment plan summarizing healthy weight and target behavior goals. At 20-minute follow-up visits during the school day, the provider will review weight and target behavior attainment and monitor co-morbidities and barriers to participation. Group 1 participants will also have access to daily MMCC afterschool programming from 3-6pm from September through May each year with tailored programming including weekly core nutrition, behavior, and cooking classes and at least five hours of physical activity.
15911012|NCT03565731|Behavioral|ACT-PA|The overall goal of the intervention is to increase bout-related moderate-to-vigorous physical (MVPA) activity to greater than 200 minutes per week. The basic structure is an initial on-site, group-based intervention workshop, written materials, weekly emails, and monthly phone calls for a total of 3 months.
15911013|NCT03565718|Behavioral|Dietary Intervention: Restaurant|Participants will receive instruction on how to follow a vegan diet for three weeks and will receive gift cards to local vegan soul food restaurants.
15911014|NCT03565718|Behavioral|Dietary Intervention: Standard/Grocery|Participants will receive instruction on how to follow a vegan diet for three weeks and will receive gift cards to grocery stores.
15911016|NCT03565692|Biological|the lung mycobiota and microbiota profile|"All sputum samples will follow regarding mycological and metagenomic analyses as summarized :
~Pre-analytical treatment combining pre-treatment with mucolytic agent and sonication action
~Separation of the pellet and supernatant, stored at -20 ° C until testing
~Galactomannan (GM) Assay on each sputum supernatant to correlate with Aspergillus colonization history
~Targeted metagenomics of bacterial communities (based on 16S amplification) and of fungal community (based on ITS2 amplification)
~Bioinformatic analysis of metagenomics raw data, correlation with bioclinical data of each patient, statistical analysis, and characterization of phenomena of co-evolution/co-exclusion according to evolutionary ecology concepts.
~Pseudomonas aeruginosa load measured by qPCR"
15911017|NCT03565692|Biological|the gut mycobiota and microbiota profile|All stool samples will follow regarding mycological and metagenomic analyses as summarized : - Separation of the pellet and supernatant, stored at -20 ° C until testing - Targeted metagenomics of bacterial communities (based on 16S amplification) and of fungal community (based on ITS2 amplification) - Bioinformatic analysis of metagenomics raw data, correlation with bioclinical data of each patient, statistical analysis, and characterization of phenomena of co-evolution/co-exclusion according to evolutionary ecology concepts. - Measurement of inflammation.
15911018|NCT03565679|Device|MEDLINE RENEWAL PULSE OXIMETRY SENSORS|An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation. Because an arterial sample of blood is not required to make the measurement, the pulse oximeter can provide non-invasive real time information.
15911019|NCT03565679|Device|CO-OXIMETRY SENSORS|A whole blood analyzer (CO-Oximeter) is used as the reference standard device for obtaining the functional SaO2 value from arterial blood samples obtained during the study.
15911020|NCT03565666|Device|iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog|iLet Bionic Pancreas insulin-only configuration with Humalog or Novolog
15911021|NCT03565666|Drug|iLet Bionic Pancreas insulin-only configuration with Fiasp|iLet Bionic Pancreas insulin-only configuration with Fiasp (faster insulin aspart)
15911022|NCT03565666|Other|Usual care|Usual care
15911023|NCT03565653|Other|High dietary salt|~4,000 mg Na+/day
15911024|NCT03565653|Other|Placebo|dextrose
15911025|NCT03565640|Device|Capio Slim Device|Participants who have been assigned to sacrospinous ligament fixation for pelvic organ prolapse will have sacrospinous ligament fixation performed with the Capio Slim Device.
15911026|NCT03565640|Device|Anchorsure Device|Participants who have been assigned to sacrospinous ligament fixation for pelvic organ prolapse will have sacrospinous ligament fixation performed with the Anchorsure Device.
15911027|NCT03565627|Device|Exercise app: 7 Minute Workout Challenge|7 Minute Workout Challenge by Fitness Guide Inc. combines aerobic and resistance training into short, 7 minute high intensity circuit training.
15911028|NCT03565627|Device|Running app: One You Couch to 5K|One You Couch to 5K by Public Health England is a popular app that aims to increase fitness by asking the user to follow a running programme with a goal to run for 30 min without break.
15911029|NCT03565614|Behavioral|Reablement|Intensive home-based rehabilitation is delivered up to 3 months by an interprofessional team (nurse, enrolled nurse, physiotherapist, occupational therapist, social worker). The entire team completed a 5-week college course. The team negotiates goal-directed contents of the rehabilitation initiatives with the user. Each user is handled deliberately based on decisions in the team in cooperation with the care managers overarching goals in admitted services. All participants have personal contact persons, and these contact persons have twice the time per participant as compared to traditional home care. The interprofessional team also has regular meetings to discuss every participant, and all rehabilitation goals activities related to those are documented.
15911030|NCT03565614|Behavioral|Traditional home care|Traditional home care and required rehabilitation efforts as by the municipality's current practice. Includes the same professions as is included in the reablement intervention, but the team has had no joint college course, does not use the systematic goal-directed and negotiated approach as the reablement intervention, and has about half the time per participant as compared to the reablement intervention.
15911031|NCT03565601|Other|Follow-up|Clinical data, radiological data and laboratory tests follow-up
15911032|NCT03565588|Behavioral|Education session with fixed incentive|"All participants will receive an education session on the risk of HIV infection and benefits from medical male circumcision. The sessions will be implemented by trained male healthcare workers who have undergone VMMC.
~All participants will receive contributions towards transport costs to access medical male circumcision at participating clinics. On completing VMMC, participants assigned to receive fixed incentives will receive payment through mobile payments. In two sites a community-led intervention will also be implemented to address social obstacles and to increase support from peers, families and social structures."
15911033|NCT03565588|Behavioral|Education session with lottery incentive|"All participants will receive an education session on the risk of HIV infection and benefits from medical male circumcision. The sessions will be implemented by trained male healthcare workers who have undergone VMMC.
~All participants will receive contributions towards transport costs to access medical male circumcision at participating clinics. On completing VMMC, participants will participate in a lottery with prizes equivalent in expected value to the fixed incentives. In two sites a community-led intervention will also be implemented to address social obstacles and to increase support from peers, families and social structures."
15911034|NCT03565575|Behavioral|Interactive tablet-based quiz|"Intervention participants play an interactive tablet based quiz including the following information components:
~Risks of HIV infection under different scenarios such as between two hypothetical individuals and with different behaviours.
~Interactive counselling on key facts around PrEP, its usability and local availability
~All individuals will have the option to sign up for contact by a nurse from the health clinic to discuss PrEP further and make an appointment for a visit. Participants will also be given a PrEP referral letter which they can present directly at one of the participating study clinics to begin PrEP. In two sites a community-led intervention will also be implemented to address social obstacles and to increase support from peers, families and social structures."
15911069|NCT03565367|Drug|Hyperpolarized Carbon C 13 Pyruvate|Given IV
15911070|NCT03565367|Procedure|Magnetic Resonance Imaging|Undergo MRI
15940327|NCT03338881|Drug|[14C]-TAK-659|[14C]-TAK-659 solution.
15911035|NCT03565562|Other|Promotion of the e-health tool by local authorities|Local authorities participating in the trial will select a referent person who will be in charge of the implementation and follow-up of the promotion. A promotion toolkit with recommendations, posters, web banners, leaflets and ready-made messages and press articles will be provided to the local authorities.
15911036|NCT03565562|Other|Promotion of the e-health tool by local authorities and GPs|In those local authorities, GPs will participate passively to the promotion of the e-health tool, by providing posters and leaflets in their waiting rooms.
15911037|NCT03565549|Behavioral|Mnemonic|A mnemonic used as a memory aid
15911038|NCT03565549|Behavioral|CCHR rule|A list of the CCHR items
15911039|NCT03565536|Drug|Nexavar|for Unresectable tumors ,After the patient had diagnosed as anaplastic thyroid cancer, Nexavar 400mg Bid was used for neoadjuvant treatment. At 1 month and 2 months after treatment, it was assessed whether surgery could be performed.
15911040|NCT03565536|Procedure|operation|If computed tomography (CT) evaluates for possible surgical treatment, complete thyroidectomy and cervical lymph node dissection are performed to completely resect thyroid tissue and metastatic lymphatic tissue.
15911041|NCT03565536|Radiation|External radiation therapy|As the successful surgery, then continue on the basis of taking on Nexavar plus external beam radiation therapy
15911042|NCT03565523|Other|Beetroot|Containing 385 mg nitrate
15911043|NCT03565523|Other|Placebo beverage|<0.1 mmol nitrate in sucrose solution with beet coloring
15911044|NCT03565510|Dietary Supplement|High-Protein Diet|The high-protein diet is composed of 35% of carbohydrate, 40% of protein, and 25% of lipid constructed around a soy protein-based meal replacement.
15911045|NCT03565497|Behavioral|Wellness Education Control Condition|As per arm of the same name
15911046|NCT03565497|Behavioral|Mindfulness Training|As per arm of the same name
15911047|NCT03565497|Behavioral|Mindfulness Training Plus IE|As per arm of the same name
15911048|NCT03565484|Drug|susceptibility guided therapy|Patients will take a gastroscopy and 2 biopsies will be attained from antrum and gastric body for H.pylori culture and antimicrobial susceptibility testing (AST). The susceptibility of amoxicillin, clarithromycin, metronidazole, levofloxacin, furazolidone and tetracycline will be tested.Then patients with positive culture will be treated with a 14-day quadruple therapy for the H.pylori eradication. The regimen contains rabeprazole 20mg bid, colloidal bismuth pectin 200mg bid, and two sensitive antibiotics determined by AST. Dose of two sensitive antibiotics are listed as follows : amoxicillin 1000mg bid, clarithromycin 500mg bid, tinidazole 500mg tid, levofloxacin 500mg qd, furazolidone 100mg bid, tetracycline 500mg qid.
15911049|NCT03565484|Drug|personal medication history guided therapy|Patients will be treated with a 14-day emprical tailored quadruple therapy for the H.pylori eradication. The regimen contains rabeprazole 20mg bid， colloidal bismuth pectin 200mg bid and two antibiotics based on personal medication history. If the patient doesn't have levofloxacin history, he will be treated with amoxicillin 1000mg bid plus levofloxacin 500mg bid. Otherwise, he will be treated with amoxicillin 1000mg bid and furazolidone 100mg bid.
15911050|NCT03565484|Drug|salvage treatment for failed eradication|If the patients failed with AST guided eradication therapy or empirical therapy, patients will be treated with another 14-day bismuth-based quadruple therapy. The regimen contains rabeprazole 20mg bid, colloidal bismuth pectin 200mg bid, tetracycline 500mg qid and furazolidone 100mg bid.
15911051|NCT03565471|Diagnostic Test|Echocardiography|Standard echocardiography.
15911052|NCT03565471|Diagnostic Test|Right side catheterization|Right side catheterization with the purpose of measuring pulmonary vascular pressures and blood saturation.
15911053|NCT03565471|Diagnostic Test|Exercise test|Exercise test on a supine bicycle with gradual increase in work load while wearing a mask that measures ventilation, oxygen uptake, carbon dioxide release and respiratory exchange rate.
15911054|NCT03565471|Diagnostic Test|Holter monitor|Holter monitor worn for 2 whole days registering heart rate.
15911055|NCT03565458|Drug|Gemigliptin|zemiglo 50mg,LG Chem
15911056|NCT03565458|Drug|Dapagliflozin|forxiga, dapagliflozin 10mg
15911057|NCT03565458|Drug|Empagliflozin|jardiance 25mg, empagliflozin
15911061|NCT03565419|Device|Smart glasses|Participants confirm the real-time ultrasound image displayed on the viewer of smart glasses.
15911062|NCT03565406|Drug|Mocetinostat Induction Phase + Ipilimumab + Nivolumab|"Treatment Cycle 1: Mocetinostat at a dose of 90 mg PO TIW; ipilimumab will be administered IV at a dose of 1 mg/kg and nivolumab will be administered IV at a dose of 3 mg/kg during the 12-week induction period. The induction phase will last for 2 treatment cycles.
~Treatment Cycle 2: Mocetinostat at a dose of 70 mg PO TIW ipilimumab will be administered IV at a dose of 1 mg/kg and nivolumab will be administered IV at a dose of 3 mg/kg during the 12-week induction period. The induction phase will last for 2 treatment cycles."
15911063|NCT03565406|Drug|Mocetinostat Maintenance Phase + Ipilimumab + Nivolumab|"De-escalation Phase 1: Mocetinostat will be administered 50 mg PO TIW during each 84-day treatment cycle. Ipilimumab will be administered IV at a dose of 1 mg/kg and nivolumab will be administered IV at a dose of 3 mg/kg
~De-escalation Maintenance Phase 2: Mocetinostat will be administered 40 mg PO TIW during each 84-day treatment cycle. Ipilimumab will be administered IV at a dose of 0.3 mg/kg and nivolumab will be administered IV at a dose of 1 mg/kg during period"
15911064|NCT03565393|Combination Product|Fibersol-2|A placebo-controlled, randomized; double-blind 2 arm trial
15911065|NCT03565380|Other|12-week community-based multi-model Tai Chi rehabilitation program|Participants will receive 12 x 90 minute sessions of supervised exercises over 12 weeks. In addition to usual care, supervised exercise will be held at the Center of Sports Training and Rehabilitation inside the University and each class will be restricted to no more than 8 participants to ensure sufficient personalized attention. Each training session involves warm-up together with stretching of lower extremity muscles, strengthening exercises of the major lower extremity muscle groups by Theraband, balancing exercise, Tai Chi training, and rest/ cool-down. All lower-extremity exercises will be performed bilaterally.
15911066|NCT03565380|Other|Usual post-operative care|No intervention will be provided
15911067|NCT03565380|Other|Untreated asymptomatic controls|No intervention will be provided
15911068|NCT03565367|Other|Gadolinium|gadolinium enhanced MRI
15911072|NCT03565354|Drug|iron isomaltoside(Monofer®)|intravenous iron isomaltoside
15911073|NCT03565341|Device|PiQo4|PiQo4 Laser System for treatment of Melasma
15911074|NCT03565328|Dietary Supplement|Nicotinamide Riboside|Nicotinamide Riboside (NR) will be started at 500 mg daily (250 mg BID) be increased at two weekly intervals by 250 mg/dose (BID) (500 mg/day) to a final dose of 1000mg PO BID (2000 mg/day).
15911075|NCT03565315|Biological|VRC-HIVMAB095-00-AB (10E8VLS)|10E8VLS is an investigational Monoclonal Antibody targeted to the membrane proximal external region and proximal viral membrane lipid region of HIV-1.
15911076|NCT03565315|Biological|VRC-HIVMAB075-00-AB (VRC07-523LS)|VRC07-523LS is an investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.
15911077|NCT03565302|Drug|Formoterol|Subjects are treated with daily inhalation of formoterol
15911078|NCT03565302|Drug|Terbutaline|Subjects are treated with daily inhalation of terbutaline
15911079|NCT03565302|Other|Placebo|Subjects are treated with placebo
15911080|NCT03565289|Diagnostic Test|Blood sample collection|During a routine blood draw an additional tube of blood will be taken for the study.
15911081|NCT03565276|Drug|Tranexamic Acid|A single dose of intravenous TxA in 100ml of 0.9% sodium chloride at 50mg/min, via a dose-escalation design
15911082|NCT03565250|Other|self understanding interview|semi-structured interview designed for assessment of identity according to Damon & Hart's 7-dimension develomental model
15911083|NCT03565237|Biological|RIXUBIS: On-Demand|RIXUBIS used under standard clinical practice in India: On-Demand treatment.
15911084|NCT03565237|Biological|RIXUBIS: Prophylaxis|RIXUBIS used under standard clinical practice in India: Prophylaxis treatment.
15911085|NCT03565211|Drug|Progesterone vaginal ring|A flexible, non-degradable PVR containing progesterone in micronized formulation and dispersed evenly throughout the ring.
15911086|NCT03565185|Other|robot-assisted gait training|Investigators will use robot-assisted gait training for rehabilitation of stroke
15911087|NCT03565185|Other|placebo|Investigators will use only conventional treatment without robot-assisted gait training
15911088|NCT03565172|Diagnostic Test|isokinetic dynamometer with ultrasound|children are lying prone on a isokinetic dynamometer with ultrasound which stretches spastic and paretic plantarflexors muscles very slowly until maximal torque tolerated. The parameters can be measured.
15911089|NCT03565172|Other|Visual Analog Scale (VAS)|the discomfort level will be measured by Visual Analog Scale (VAS) completed by children. 0 = no discomfort and 10 = maximum discomfort
15911090|NCT03565172|Diagnostic Test|Stretching|the ankle of children will be mobilized for 5 minutes (first two weeks) to 10 minutes (last two weeks).
15911091|NCT03565159|Biological|Prevenar 13|Pneumococcal polysaccharide conjugate vaccine
15911092|NCT03565159|Other|Sodium Chloride 0.9%|Placebo
15911093|NCT03565146|Device|PiQo4 Laser System|PiQo4 Laser System for treatment of pigmented lesions
15911094|NCT03565133|Dietary Supplement|Quinine sham feeding quinine|Oral sham feeding with quinine
15911095|NCT03565133|Dietary Supplement|Gastric quinine|A gastric capsule containing quinine
15911096|NCT03565133|Dietary Supplement|Oral sham feeding placebo|Oral sham feeding with placebo (tap water)
15911097|NCT03565133|Dietary Supplement|Gastric placebo|A gastric capsule containing placebo (cellulose)
15911098|NCT03565120|Radiation|Aggressive Thoracic Radiotherapy|The target of the radiotherapy includes primary tumor and the locoregional positive lymph nodes, with a dose(BED)≥53Gray(Gy)
15911099|NCT03565094|Drug|Lu AF28996 solution|"Oral solution (0.1-0.2 mg/mL)
~Following each cohort, a dosing conference will be held where tolerability, safety and preliminary PK results from the previous cohorts will be reviewed before deciding on the next doses"
15911100|NCT03565094|Drug|Lu AF28996 capsule|hard capsule orally QD: one dose lower than the highest dose level in part A
15911101|NCT03565081|Device|PWS elastic band training group|PWS participants received 9 sets exercises for the major muscle groups, over 24 weeks, three times a week, for a total of 72 sessions.
15911102|NCT03565068|Drug|MK-8189|MK-8189 4 mg tablet(s) will be administered orally QD for a total daily dose of 4 mg, 8 mg, 12 mg, 16 mg, 20 mg, 24 mg, 36 mg or 48 mg.
15911103|NCT03565068|Drug|Placebo|MK-8189 dose-matching placebo tablets will be administered orally QD.
15911104|NCT03565068|Drug|Background AAP Therapy|Participants with schizophrenia in Panel C will be on background therapy with an AAP medication (e.g., olanzapine, quetiapine, paliperidone, asenapine, iloperidone, aripirprazole, lurasidone, risperidone [not to exceed daily dose of 6 mg], or ziprasidone) throughout the study. Participants should be on a stable and well tolerated treatment regimen for at least 2 months prior to screening. NOTE: clozapine is not allowed.
15911105|NCT03565055|Behavioral|IPCST|"Integrative Psychosocial & Community Skills Training (IPCST) programme
~The IPCST programme includes:
~psychoeducation, internalized stigma reduction, & strength and coping enhancement
~motivational interviewing skills
~Neurocognitive and social cognitive training (Au, Tsang, So, Bell, Cheung, et al., 2015)
~augmented supported employment with social skills training (Tsang, Fung, Li, Leung & Cheung, 2010) and
~family and patient involvement in care"
15911106|NCT03565055|Behavioral|E.A.S.Y|"The E.A.S.Y. (Early Assessment Service for Young People with Early Psychosis) Programme is a service programme for people suffering from early psychosis.
~The E.A.S.Y programme includes:
~Extensive public education
~Early referral and assessment
~Ongoing treatment services"
15911107|NCT03565042|Procedure|Arthroscopy|Arthroscopy of swollen joint (ankle/knee)
15911108|NCT03565029|Drug|XELOX|Capecitabine and Oxaliplatin (4x cycles)
15911109|NCT03565029|Radiation|Radiotherapy|Pelvic radiotherapy
15911110|NCT03565016|Other|no interventional study|no interventional study
15911111|NCT03565003|Drug|JAB-3068|25 mg,100 mg
15911112|NCT03564990|Other|interactive, multifaceted approach|A health education module consisting of a lecture and workshop was incorporated into a health-care course.
15911113|NCT03564990|Other|conventional approach|conventional follow-up
15911114|NCT03564977|Biological|CD19-targeted CAR-T cells|MDR+ patients after autologous stem cell transplantation were treated with CD19-targeted CAR-T cells.
15911115|NCT03564964|Drug|SUVN-502|Tablet
15911116|NCT03564951|Procedure|Atrial fibrillation ablation|ablation of Atrial fibrillation using spatio-temporal dispersion
15911117|NCT03564951|Procedure|Atrial fibrillation ablation|ablation of concordance zones using isochrone and voltage maps
15911119|NCT03564925|Procedure|Wide area circumferential ablation|Wide area circumferential ablation with contact force catheter will be performed in Patients allocated in this group,the induction of atrial fibrillation by isoproterenol or programmed stimulation and burst pacing will be performed. If frequent atrial premature beats are found beyond pulmonary vein, activation mapping will be performed for eliminating the triggers. If atrial tachycardias(ATs)are induced, activation mapping the ATs and ablation will be performed. Electrical isolation of pulmonary veins and elimination the triggers and ATs induced by isoproterenol or programmed stimulation and burst pacing are the endpoints of ablation
15911120|NCT03564925|Procedure|Cryoballoon ablation|In the cryoballoon procedures, pulmonary vein isolation (PVI) was achieved using fluoroscopic guidance to position the cryoballoon catheter. Once PV-to-balloon occlusion was confirmed by retrograde radiopaque contrast agent retention, circumferential ablation was performed by freezing with a single-shot delivery of coolant to the balloon.
15911121|NCT03564912|Drug|Capecitabine Oral Tablet [Xeloda]|2 week group: capecitabine 1000mg/m2 d1-10; oxaliplatin 85mg/m2; q2w 3 week group: capecitabine 1000mg/m2 d1-14; oxaliplatin 130mg/m2; q3w
15911122|NCT03564899|Behavioral|Lighter intensity physical activity intervention|Prescription of 300 minutes/week of physical activity at an intensity of 40-60% of heart rate reserve
15911123|NCT03564899|Behavioral|Higher intensity physical activity intervention|Prescription of 150 minutes/week of physical activity at an intensity of 60-80% of heart rate reserve
15911124|NCT03564886|Drug|Hyperosmolar Saline|The hyperosmolar solution will be created by adding 120cc of 23.4% NS solution to a 3L bag of LR.
15911125|NCT03564886|Drug|Normal saline|Lactate Ringer's (LR, 273mOsm/L)
15911130|NCT03564860|Procedure|Device data collection|Collection of device electrograms and 12-lead ECG during a device follow-up visit
15911131|NCT03564847|Behavioral|LTP Plus|"LTP+Dads is a 12 - session group integrated parenting intervention: i.e LTP (Learning through Play) which includes a pictorial calendar, consisting of stages of child development from birth to 3 years. It includes parent-child play and other activities that promote parental involvement, learning, and attachment. In each stage, there are five areas of child development: sense of self, physical, relationships, understanding, and communication. All areas are written in simple, low-literacy language.
~Second component of intervention is CBT adapted from Jeanne Miranda manual (Group CBT for Depression, group leaders guide book-2006) focusing on the three areas: thoughts and your mood, activities and your mood, people interaction and your mood.
~Third component of intervention is content taken from Ed Bader's manual (Focus on Fathers) includes importance of fathers in child development, stress management at work and home, budgeting, anger management, conflict resolution and time management."
15911132|NCT03564834|Procedure|Laparoscopic gastrectomy|Patients will receive laparoscopic gastrectomy within one week after randomization.
15911133|NCT03564834|Procedure|Open gastrectomy|Patients will receive open gastrectomy within one week after randomization.
15911135|NCT03564808|Drug|MSC|Adipose tissue enriched with mesenchymal stem cells
15911136|NCT03564795|Device|KeraStat Gel|Wound dressing for partial thickness burns
15911137|NCT03564795|Device|Silver Sulfadiazine|Wound dressing for partial thickness burns
15911138|NCT03564782|Biological|PVSRIPO|The live, attenuated, oral (Sabin), serotype 1 poliovirus vaccine booster will be administered 1 week before PVSRIPO injection. The study drug, PVSRIPO, is the live attenuated, oral (Sabin) serotype 1 poliovirus vaccine containing a heterologous internal ribosomal entry site (IRES) derived from the human rhinovirus type 2 (HRV2). It will be given at a dose of 1x10^8 TCID50 (tissue culture infectious dose) directly into the breast tumor.
15911139|NCT03564769|Behavioral|Intervention Arm|Individuals randomized to the intervention group will receive skin cancer screening educational materials.
15911140|NCT03564769|Other|AAD SPOTmeⓇ skin cancer screening|All study participants will have participated in the AAD SPOTmeⓇ skin cancer screening program in either 2016 or 2017.
15911141|NCT03564756|Dietary Supplement|Vitamin C|1000mg Vitamin C per day
15911142|NCT03564743|Diagnostic Test|Evaluation of ASAS criteria|Perform ASAS criteria at the time of physician diagnosis of chronic low back pain in rheumatological practice.
15911143|NCT03564730|Procedure|Simultaneous Knee Arthroplasty (UKA)|Patient will have both knees completed under one anesthetic.
15911144|NCT03564730|Procedure|Staged Knee Arthroplasty (UKA)|Patient will have knees completed under 2 anesthetics.
15911145|NCT03564717|Other|Segmented three dimensionally printed transfer tray|Segmented indirect bonding transfer tray
15911146|NCT03564704|Drug|Dexamethasone|Dexamethasone will be added in Pre-phase Regimen, Induction-Regimen, Consolidation-Module of PDT-ALL-LBL protocol.
15911147|NCT03564704|Drug|vincristine|Vincristine will be added to Induction-Regimen, Consolidation-Module and Maintenance-Module of PDT-ALL-LBL protocol.
15911148|NCT03564704|Drug|Cyclophosphamide|CTX will be added to Induction-Regimen, Consolidation-Module and Maintenance-Module of PDT-ALL-LBL protocol.
15911149|NCT03564704|Drug|Idarubicin|IDA will be added to Induction-Regimen and Consolidation-Module of PDT-ALL-LBL protocol.
15911150|NCT03564704|Drug|Pegaspargase|PEG-ASP will be added to Induction-Regimen and Consolidation-Module of PDT-ALL-LBL protocol.
15911151|NCT03564704|Drug|Adriamycin|Adriamycin will be added to Consolidation-Module of PDT-ALL-LBL protocol.
15911152|NCT03564704|Drug|Methotrexate|Methotrexate will be added to Consolidation-Module of PDT-ALL-LBL protocol.
15911153|NCT03564704|Drug|6-mercaptopurine.|Mercaptopurine will be added to Consolidation-Module and Maintenance-Module of PDT-ALL-LBL protocol.
15911154|NCT03564704|Drug|Etoposide|VP-16 will be added to Consolidation-Module of PDT-ALL-LBL protocol.
15911155|NCT03564704|Drug|Cytarabine|AraC will be added to Consolidation-Module of PDT-ALL-LBL protocol.
15911156|NCT03564704|Procedure|Bone marrow aspiration|Bone marrow aspiration and additional tests will be performed in all module of PDT-ALL-LBL protocol.
15911157|NCT03564704|Procedure|Intrathecal injection|Intrathecal injection of chemotherapy will be performed in PDT-ALL-LBL protocol.
15911158|NCT03564704|Radiation|Radiation therapy|Radiation therapy will be performed for mediastinum and/or central nervous system leukemia/lymphoma in PDT-ALL-LBL protocol.
15911159|NCT03564704|Genetic|NGS|Next-Generation-Sequencing (NGS) will be performed in PDT-ALL-LBL protocol.
15911160|NCT03564704|Procedure|allogeneic hematopoietic stem cell transplantation|Allo-HSCT will be added to LBL patients with available donor in PDT-ALL-LBL protocol.
15911161|NCT03564704|Diagnostic Test|Flow-MRD|Flow-MRD will be added to PDT-ALL-LBL for bone marrow and cerebrospinal fluid samples.
15911162|NCT03564704|Diagnostic Test|FISH|FISH will be added to PDT-ALL-LBL for bone marrow samples.
15911163|NCT03564704|Diagnostic Test|Flow immunophenotyping|Flow immunophenotyping will be performed in PDT-ALL-LBL protocol.
15911164|NCT03564704|Diagnostic Test|Karyotyping|Karyotyping will be performed in PDT-ALL-LBL protocol.
15911165|NCT03564704|Drug|Chidamide|HDACi chidamide will be added to induction regimen, consolidation and maintenance module of PDT-ALL-LBL.
15911166|NCT03564704|Diagnostic Test|PET-CT scan|PET-scan will be performed for T-LBL patients for MRD assessment in PDT-ALL-LBL.
15911167|NCT03564691|Drug|MK-4830|MK-4830 will be administered intravenously (IV) Q3W. In Part C, MK-4830 will be administered after completion of pembrolizumab infusion. Dose escalation will proceed based on emerging safety and tolerability data of MK-4830 as monotherapy (Part A and B) and as combination therapy with pembrolizumab (Part C). For each dose level, an assessment will be made of the safety and tolerability data in order to define the next dose level to be tested.
15911168|NCT03564691|Drug|Pembrolizumab|Pembrolizumab will be dosed at 200 mg IV Q3W.
15911169|NCT03564691|Drug|Carboplatin|Carboplatin will be administered intravenously (IV) Q3W.
15911170|NCT03564691|Drug|Pemetrexed|Pemetrexed will be administered intravenously (IV) Q3W.
15911171|NCT03564691|Drug|Lenvatinib|Lenvatinib will be administered orally once daily.
15911172|NCT03564691|Drug|Paclitaxel|Paclitaxel will be administered intravenously (IV) QW on Days 1, 8, and 15 of each 21-day cycle until disease progression or prohibitive toxicity (Arm J) and on Days 1, 8, and 15 Q4W until disease progression or prohibitive toxicity (Arm K).
15911173|NCT03564691|Drug|Cisplatin|Cisplatin will be administered intravenously (IV) Q3W.
15911174|NCT03564678|Dietary Supplement|Levocarnitine|Given IV
15911175|NCT03564678|Drug|Vitamin B Complex|Given PO
15911176|NCT03564665|Dietary Supplement|400mg Magnesium Glycinate BID|400mg Magnesium Glycinate BID for 8 weeks.
15911177|NCT03564665|Other|Placebo|Placebo BID for 8 weeks.
15911178|NCT03564652|Dietary Supplement|Balanced energy-protein (BEP)|Lactating women in the intervention arms will receive approximately 800 Kcal/day and around 16-21 gram of protein in a day in the form of ready-to-use supplement.
15911179|NCT03564652|Drug|Azithromycin|A single prophylaxis dose of 20 mg/kg in suspension form, reconstituted by trial staff before dose administration by the same.
15911180|NCT03564626|Other|Health-IT Only|"Training patient and caregiver on Patient Buddy and EncephalApp
~Counseling regarding readmission
~Daily contact through app
~Standard of care counseling regarding readmission and discharge instructions
~Follow up phone calls and visits per standard of care or as necessitated by app"
15911181|NCT03564626|Other|Health-IT + Scheduled Follow Up|"Training patient and caregiver on Patient Buddy and EncephalApp
~Counseling regarding readmission
~Daily contact through app
~Standard of care counseling regarding readmission and discharge instructions
~Follow up phone calls at Week 1 and Week 3
~In-person follow up visits at Week 2 and Week 4"
15911182|NCT03564613|Drug|DTG|Subjects with DTG exposure during any trimester will be included
15911183|NCT03564587|Behavioral|AWAKE|Behavioral intervention called Achieving Wellness After Kancer in Early Life (AWAKE) is focused on increasing hope in order to improve quality of life and health-promoting behaviors in survivors of young adult cancer. The AWAKE mobile app contains eight modules for participants to complete over 8 weeks with the ability to review prior modules. Participants receive a prompt on their mobile device weekly to complete each module and/or they will receive a text reminder. The app includes health education messaging, weekly homework assignments, the ability to track progress towards goals with self-monitoring and graphical depictions of progress, videos of inspirational materials, and a portal for interacting with their coach.
15911184|NCT03564574|Combination Product|Lipid Emulsion|All patients in the 'Study group' received a single dose of 100 ml of 20 percent Lipid emulsion as an infusion over 1 hour along with routine treatment as per institution protocols. Atropine was administered to patients by doubling dose method, which comprised of administering atropine starting from 2mg and to double the dose and administer till complete atropinization. Following this an infusion of 10 percent of the atropinizing dose was given every hour. Patients were evaluated using a standardized clinical interview, physical examination, laboratory tests.
15911185|NCT03564548|Drug|PPP001|Group assigned to PPP001
15911186|NCT03564548|Drug|Morphine sulfate or Hydromorphone or Oxycodone|Group assigned to morphine sulfate or hydromorphone or oxycodone
15911187|NCT03564535|Device|Self fixating group|Monofilament polyester mesh with polylactic acid (PLA) microgrips of size 11*15 will be used. It is an isoelastic large-pore knitted fabric with a density of 73g/m2 at implantation and 38g/m2 after microgrips absorption which will be at 18 months. The resorbable micro grips provide immediate adherence to surrounding muscle and adipose tissue during the initial days post hernia surgery, serving as an alternate method of fixation to traditional sutures, tacks, staples, or fibrin sealants. No additional tacks, staples, sutures, or fibrin sealant will be used.
15911296|NCT03563716|Drug|Placebo|Placebo will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
15911188|NCT03564535|Device|Tacker fixation group|Patients will be undergoing polyester mesh ﬁxation with non-absorbable tacks. The tacks would be used such that they avoid bony prominences and vascular and neural structures. One or two tacks will be put at the Cooper's ligament and another applied laterally superior to the iliopubic tract in the anterior abdominal wall. In any patient, the maximum number of tacks applied will not exceed three.
15911189|NCT03564522|Procedure|cardiac catheterization|cardiac catheterizations will be clinically indicated and the study will collect this clinical data.
15911190|NCT03564522|Radiation|Cardiac MRI|If clinically indicated, the study will collect data from MRIs.
15911191|NCT03564509|Drug|FE 999302 (dose 1) and follitropin delta|Dose 1 of FE 999302, a recombinant human chorionic gonadotropin (rhCG) solution for subcutaneous injection; individualised follitropin delta dose
15911192|NCT03564509|Drug|FE 999302 (dose 2) and follitropin delta|Dose 2 of FE 999302, a rhCG solution for subcutaneous injection; individualised follitropin delta dose
15911193|NCT03564509|Drug|FE 999302 (dose 3) and follitropin delta|Dose 3 of FE 999302, a rhCG solution for subcutaneous injection; individualised follitropin delta dose
15911194|NCT03564509|Drug|FE 999302 (dose 4) and follitropin delta|Dose 4 of FE 999302, a rhCG solution for subcutaneous injection; individualised follitropin delta dose
15911195|NCT03564509|Drug|FE 999302 (dose 5) and follitropin delta|Dose 5 of FE 999302, a rhCG solution for subcutaneous injection; individualised follitropin delta dose
15911196|NCT03564509|Other|Placebo and follitropin delta|Placebo and individualised follitropin delta dose
15911197|NCT03564496|Other|Active tDCS|The simultaneous tDCS will be performed at up to 2 mA dose intensity to determine CMRO2 changes from when the tDCS is on when the tDCS is off. The stimulation (left anodal at DLPFC regions) consists of 15-min up to 4 mA tDCS using 5x5 cm electrode sponge with ~30s ramp-up and ramp-down periods.
15911198|NCT03564496|Other|Sham (placebo) stimulation|MRI-compatible tDCS off (immediately before and after tDCS)
15911199|NCT03564470|Drug|Chidamide|Chidamide will be administrated at dose of 10mg/day in chidamide arm in PDT-Ph-Like protocol. PDT-Ph-Like protocol for chidamide arm consists of diagnostic test (bone marrow aspiration, flow immunophenotyping, karyotyping，FISH, NGS, Flow-MRD), induction regimen (chidamide, prednisone, vincristine, cyclophosphamide, idarubicin, pegaspargase), consolidation regimen (chidamide, cytarabine, methotrexate, dexamethasone, cyclophosphamide, etoposide, 6-mercaptopurine, pegaspargase), MRD assessment and maintenance regimen, intrathecal injection chemotherapy, radiation therapy for CNS-involved leukemia and allogeneic hematopoietic stem cell transplantation.
15911200|NCT03564470|Drug|Dasatinib|Dasatinib will be administrated at a dose of 100mg/day in dasatinib arm in PDT-Ph-Like protocol. PDT-Ph-Like protocol for dasatinib arm consists of diagnostic test (bone marrow aspiration, flow immunophenotyping, karyotyping，FISH, NGS, Flow-MRD), induction regimen (dasatinib, prednisone, vincristine, cyclophosphamide, idarubicin, pegaspargase), consolidation regimen (dasatinib, cytarabine, methotrexate, dexamethasone, cyclophosphamide, etoposide, 6-mercaptopurine, pegaspargase), MRD assessment and maintenance regimen, intrathecal injection chemotherapy, radiation therapy for CNS-involved leukemia and allogeneic hematopoietic stem cell transplantation.
15911201|NCT03564457|Other|No interventions will take place (observational)|No interventions will take place (observational)
15911202|NCT03564444|Biological|Bivalent influenza vaccine|A single dose of bivalent vaccine (10^7±5 fluorescent focus unit of 2 cold-adapted, attenuated, temperature-sensitive, 6:2 reassortant influenza strain) will be administered as intranasal spray on Day 1.
15911203|NCT03564444|Other|Placebo|A single dose of placebo matched to bivalent influenza vaccine will be administered as intranasal spray on Day 1.
15911204|NCT03564431|Device|Magnetic resonance|magnetic resonance spectrum of brain
15911205|NCT03564418|Procedure|Ultrasound-Guided Thermocoagulation of Lumbar facet joints|"Prone position: Thanks to a high-resolution ultrasound and a 5 MHz curved probe, we will use the ultrasound technique described by Greher et al to reach the target points.
~Then, in order to check the correct positioning of the needles, we will inject 1 ml of a solution of contrast medium (omnipaque® 300 mg / ml of Iohexol) to observe them using the standard Fluoroscopic method. Wrongly positioned needles will be correctly repositioned and these patients will be excluded from ODI and VAS scale statistics.
~To ensure the effectiveness of the injury by thermocoagulation, sensory electrical stimulation is performed to confirm that the needle is close to the posterior ramus (50Hz, 0-3 volts) and another electrical stimulation is performed to confirm that there is no motor stimulation (2Hz, 0-3 volts). After injecting 1 ml of 2% linisol® through the needle, denervation of the facet will be performed with an electrode at 68 ° C for 90 seconds."
15911206|NCT03564418|Procedure|Fluoroscopy-Guided Thermocoagulation of Lumbar facet joints|"Prone position: We will use the standard fluoroscopic method to reach the target points. (maximum three levels, same side). Then, in order to check the correct positioning of the needles, we will inject 1 ml of a solution of contrast medium (omnipaque® 300 mg / ml of Iohexol). The correct location being the superolateral edge of the lateral facet and the diffusion of the contrast material at the level of the medial branch observed thanks to an anteroposterior radioscopic view. Then the location of the needles is confirmed by a lateral radioscopic view.
~To ensure the effectiveness of the injury by thermocoagulation, sensory electrical stimulation is performed to confirm that it is close to the posterior ramus (50Hz, 0-3 volts) and another electrical stimulation is performed to confirm that there is no motor stimulation (2Hz, 0-3 volts). After injecting 1 ml of 2% linisol® through the needle, denervation of the facet will be performed with an electrode at 68 ° C for 90 seconds."
15911207|NCT03564405|Device|UNI-DEB|Applicate the TACE with UNI-DEB to unresectable hepatocellular carcinoma patient
15911208|NCT03564392|Behavioral|Acceptance Based Behavioral Intervention|This intervention focuses on acceptance-based strategies with an emphasis on willingness to experience less pleasurable internal experiences (e.g., pleasure from eating calorically-dense foods) and aversive internal experiences (e.g., hunger, food cravings). Strategies to increase this willingness will be taught, including defusion (i.e., getting psychological distance from internal experiences to allow oneself to act independently of them). Mindful decision-making, as it relates to eating and exercise, will also be emphasized. Clarification and commitment to core values is another key component, as living life in accordance with one's values (e.g., health) makes willingness to make difficult choices worthwhile. Standard behavioral techniques for weight loss (i.e., self-monitoring, stimulus control, psychoeducation) will also be included.
15911209|NCT03564379|Drug|JNJ-42165279|25 mg JNJ-42165279 tablet will be administered orally.
15911210|NCT03564379|Drug|Placebo|Matching placebo tablet will be administered orally.
15911214|NCT03564327|Procedure|Wide antrum circle ablation|As standard hospital policy
15911215|NCT03564327|Procedure|External electric cardioversion|Three attempts (200-250 joules)
15911216|NCT03564314|Other|SUPPORT AKI Clinical Decision Support|Surgical units will receive a multidimensional clinical decision support intervention consisting of: (1) electronic and non-computerized tools to alert for early recognition of AKI, (2) educational program for physicians and nursing staff, (3) decision support tools with guidance on fluid therapies, medication management, investigations for AKI, and consultation with specialists.
15911217|NCT03564301|Drug|Placebo oral capsule|Immediately after the end of non surgical treatment of periimplantitis and depending on the result of randomization, the exact number of tablets of the placebo to be taken during the following days will be given to the patient.
15911218|NCT03564301|Drug|Metronidazole 250 MG|Immediately after the end of non surgical treatment of periimplantitis and depending on the result of randomization, the exact number of tablets of the antibiotic to be taken during the following days will be given to the patient.
15911219|NCT03564288|Drug|SKI-G-801|SKI-G-801 is administered as an IV infusion over 10 minutes
15911220|NCT03564275|Radiation|Proton Boost|13-15 treatments with proton therapy given as a boost to standard of care photon therapy
15911221|NCT03564262|Other|Low Sodium Meal (138 mg sodium)|One Low Sodium Meal
15911222|NCT03564262|Other|High Sodium Meal (1,495 mg sodium)|One High Sodium Meal
15911223|NCT03564249|Device|MiniCap|The MiniCap device consists of small, completely inert mini-capsules that, once ingested, can be imaged inside the gastrointestinal tract using MRI, thereby creating a new MRI alternative to the radiopaque marker X-ray test to measure gut transit. The MRI mini- capsules are visualised in the gut using a single fat, water, in-phase and out-of-phase scan
15911224|NCT03564236|Device|Nasal High Flow Therapy|Nasal High Flow Therapy (nHFT) is an innovative therapy for patients with respiratory diseases. It supplies heated, humidified, and oxygen-enriched air at high flow rates through a nasal cannula. Because the air is provided through an open system with a nasal cannula, it is relatively easy to apply and suggested to be very comfortable for patients. The technique has been shown to be effective in the treatment of hypoxemic respiratory failure, mainly in neonates[2] and patients with acute hypoxemic respiratory failure on intensive care units (ICU).[3]
15911225|NCT03564236|Other|Standard care|Standard regular care of a COPD exacerbation
15911226|NCT03564210|Behavioral|Screen time permitted|Cohort will not be directed to abstain from screen time
15911227|NCT03564210|Behavioral|Screen Time Abstain|Cohort will be directed to abstain from screen time
15911228|NCT03564197|Other|18F-PD-L1|18F-PD-L1 PET/CT scan
15911229|NCT03564184|Behavioral|MT during NICU|Music therapy (MT) by trained music therapist, 3 times/week for 30-40 minutes/session during NICU hospitalization. Involves primary caregiver and infant in musical communication matched to infant post-menstrual age, family/cultural preferences, and infant readiness for stimulation. Music therapist assesses infant´s needs and behavior state, supports caregiver in using basic touch (e.g., hand lightly and statically on infant´s chest or back to perceive breathing pattern) and caregiver´s hummed/sung voice matched to infant behavioral responses, to promote infant state regulation and bonding. Music includes input from music therapist as needed, and multimodal aspects such as gentle dynamic touch when infant demonstrates readiness. MT may occur while infant is held in a static manner by caregiver or is resting in his/her isolette or basinet. MT may occur during skin-to-skin care, if such care is part of standard care.
15911230|NCT03564184|Behavioral|MT after NICU|Music therapy offered by trained music therapist, 7 times for approximately 45 minutes/session across first 6 months following discharge from initial NICU hospitalization. Sessions include infant and caregiver, and siblings, if desired, and occur at home or in municipal settings. MT after NICU consists of a consult-to-parent model with each session including a brief verbal check-in regarding infant´s progress, musical interactions with music therapist modelling musical engagement, discussion of current challenges and strategies for using musical interactions to address needs in areas such as infant self-regulation, parent/infant interaction, and challenges with bonding. Caregivers will demonstrate techniques discussed during session, and form a brief plan for use of musical interaction in the interim before next session. Sessions will be adapted to infant developmental level and ongoing needs.
15911231|NCT03564184|Other|Standard care|Includes necessary medical care and standard supportive interventions offered as part of care during hospitalization, and standard follow-up procedures post-hospitalization.
15911232|NCT03564171|Combination Product|Prehabilitation|stress counseling, exercise, nutritional counseling, smoking cessation counseling
15911233|NCT03564158|Drug|meropenem-vaborbactam|Meropenem-Vaborbactam being studied for effects on TQT
15911234|NCT03564158|Drug|Placebo|Placebo
15911235|NCT03564158|Drug|Moxifloxacin|Active Comparator
15911236|NCT03564145|Drug|S5G4T-1|once a day topical cream
15911237|NCT03564132|Drug|Yigansan|Yigansan granules
15911238|NCT03564132|Drug|Placebo|One-tenth concentration of Yigansan manufactured to mimic Yigansan granules
15911239|NCT03564119|Drug|S5G4T-1|once a day topical cream
15911240|NCT03564119|Drug|S5G4T-2|once a day topical cream
15911241|NCT03564106|Drug|intraarticular radiofrequency + intraarticular methylprednisolone|intraarticular radiofrequency + intraarticular methylprednisolone (30 mg)
15911242|NCT03564106|Drug|intraarticular methylprednisolone|intraarticular methylprednisolone (30 mg)
15911243|NCT03564093|Drug|Intranasal Drug|1µg/kg of dexmedetomidine is given 30 minutes prior to intravenous cannulation or lumbar puncture
15911244|NCT03564093|Drug|Intranasal Drug|Intranasal 4,5% saline is given as a placebo 30 minutes prior to intravenous cannulation or lumbar puncture
15911245|NCT03564080|Other|Combined - PAD and CAD|12-week supervised exercise programme in a hospital setting
15911297|NCT03563703|Device|Ultrasound|Ultrasound allows viewing veins and surrounding anatomical structures, making it easier to perform the placement of a cannula into a peripherally located vein in real time. This process allows the cannulation of veins that are unable to be visualised or palpated.
15940328|NCT03338881|Drug|TAK-659|TAK-659 tablets.
15911246|NCT03564067|Device|Soterix Medical tDCS mini-Clinical Trials system (mini-CT)|Participants are provided with an activation code. This code will unlock a single session with the pre-set 30 minute duration and intensity (direct current 2mA, current density 0.80A/m2, with anode over the left and cathode over the right dorsolateral prefrontal cortex, respectively). Home-based tDCS will involve 30-min tDCS (3 days per week) for the first 3 months and once weekly for the subsequent 3 months.
15911247|NCT03564067|Behavioral|Computerized CBT (cCBT)|Each tDCS session will be delivered in combination with a computerized CBT module and participants will progress through the computerized CBT course (Beacon Therapist-Assisted-Internet-Delivered CBT) over the 6 months of treatment at their own pace.
15911248|NCT03564054|Procedure|Photodynamic Therapy|Participants on this arm will be treated with photodynamic therapy. PDT is a two-stage process. The first stage of PDT is the intravenous injection of porfimer sodium (Photofrin) administered as a single slow intravenous injection over 3 to 5 minutes. The second stage involves the application of laser light to the tumor by bronchoscopy.
15911249|NCT03564054|Procedure|Argon Plasma Coagulation|"Participants on this arm will be treated with argon plasma coagulation. A flexible probe housing a wire delivers high-frequency, high-voltage electric current to a monopolar tungsten electrode present at the tip of the probe. Argon gas flows through the probe, and is charged or ionized to produce plasma as it flows around the tungsten electrode. Electric current flows through the plasma to the nearest tissue, and heat is produced as it passes through the tissue. Increased resistance created by coagulated tissue impairs the flow of electric current, and keeps the ablation depth to 1 to 2 mm."
15911250|NCT03564041|Behavioral|Sahaj Samadhi Meditation (SSM)|This is the experimental arm of the study, where participants will be trained in a form of meditation that may improve depressive symptoms.
15911251|NCT03564041|Behavioral|Health Enhancement Program (HEP)|This is the active control group of the study, where participants will be educated on health promotion, healthy diet, music, and exercise, but do not learn breathing techniques, or meditation.
15911252|NCT03564028|Other|energy conservation technique|During the session of stair climbing, patients will perform a break at least of 5 seconds every 3 steps.
15911253|NCT03564028|Other|control session|Patients will realize one session of stair climbing at their own pace
15911254|NCT03564015|Other|Smartphone app|Apple or Android app to provide education to guide functional recovery and allow recording of pain, management, and functional outcome using the Activities Scale for Kids performance version (ASKp) at home
15911255|NCT03564015|Other|Paper handout|Paper handout to guide functional recovery. Also includes a version of the smartphone app described above that only allows recording of pain, functional outcome, and management at home.
15911256|NCT03563989|Device|Implantation of Stent (PCI)|Treatment of CTO with Percutaneous Coronary Intervention (PCI) Patients are randomized to receive either self-expandable stent or balloon expandable stent
15911257|NCT03563976|Other|Retrospective Study|The medical charts are the subjects. The institutional charts will be identified by the use of definitive radiation therapy correlating with an early stage lung cancer diagnosis during the above time frame. The data from these charts will be entered into a password protected excel spreadsheet. The charts will be identified by name, medical record number, date of birth, and social security number. These are all patients treated by all hospitals and clinics affiliated with UTSW and Parkland. At the time of study, some of the patients will have expired but some will be alive and in the regional North Texas area. Thus, given the minimal risk nature of this retrospective chart review, we could not reasonably conduct this research with a full waiver of consent. The NLST external dataset is proved by the NCI, with no identifying characteristics.
15911258|NCT03563963|Drug|Ropivacaine 0.5% Injectable Solution|Ropivacaine 0.5% will used to inflate the endotracheal tube cuff using the stethoscope guided inflation technique described by Kumar and Hirsch (2). The anesthesiologist will documented the volume in millilitres instilled into the cuff to create a seal. Once a seal was created the anesthesiologist will documented the ETT cuff pressure. If an endotracheal cuff leak occurred during the surgical procedure, the randomized solution was used to inflate the cuff.
15911259|NCT03563963|Drug|Lidocaine 2% Preservative-Free Injectable Solution|Lidocaine 2% will used to inflate the endotracheal tube cuff using the stethoscope guided inflation technique described by Kumar and Hirsch (2). The anesthesiologist will documented the volume in millilitres instilled into the cuff to create a seal. Once a seal was created the anesthesiologist will documented the ETT cuff pressure. If an endotracheal cuff leak occurred during the surgical procedure, the randomized solution was used to inflate the cuff.
15911260|NCT03563963|Other|Air|Air will used to inflate the endotracheal tube cuff using the stethoscope guided inflation technique described by Kumar and Hirsch (2). The anesthesiologist will documented the volume in millilitres instilled into the cuff to create a seal. Once a seal was created the anesthesiologist will documented the ETT cuff pressure. If an endotracheal cuff leak occurred during the surgical procedure, the randomized solution was used to inflate the cuff.
15911261|NCT03563950|Drug|Rifampin|Specified dose on specified days
15911262|NCT03563950|Drug|BMS-986224|Specified dose on specified days
15911263|NCT03563937|Drug|Phenprocoumon|Follow the physician's prescription.
15911264|NCT03563937|Drug|Apixaban|2.5 mg or 5 mg, twice daily
15911265|NCT03563937|Drug|Rivaroxaban (Xarelto, BAY59-7939)|15 mg or 20 mg, once daily
15911266|NCT03563937|Drug|Edoxaban|30 mg or 60 mg, once daily
15911267|NCT03563924|Other|"Setting up a specific care path AlloTC for management of TVE in patients with cancer"|"Setting up a specific care path AlloTC for management of TVE in patients with cancer with a specific coordination nurse within the AlloTC multidisciplinary team as a privileged interlocutor for health professionals and patients with the aim of simplifying the care pathways and ensuring a hospital-city interface organized in collaboration with the attending physician, to develop and publicize tools available for patients and caregivers (information documents, patient monitoring protocols, etc.)"
15911298|NCT03563703|Device|Near Infrared Light|Infrared technologies allows illuminating the vein with a near-infrared light, which is absorbed by blood and reflected by adjacent tissue.
15911299|NCT03563690|Other|treatment1|"Acupoints：Liangqiu（ST34）,Xuehai（SP10）,Neixiyan（EX-LE4）,Dubi(ST35),Yanglingquan (GB34)and Yinlingquan (SP9)
~operation: the needles will be manipulated using techniques including lifting, thrusting, twisting, and rotating, until De Qi is achieved for 30 minutes."
15911421|NCT03563144|Biological|GI-4000|Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins
15911268|NCT03563911|Behavioral|Brief Mindfulness-Based Intervention (BMBI)|The BMBI is be based on a BMBI which demonstrated analgesic effects in a previous study. Relative to full-length interventions, we will employ a brief intervention; the 20-minute BMBI session will include education on the foundational concepts of mindfulness and its relevance to chronic pain (5 minutes) and a guided mindfulness practice involving focused attention on the breath and monitoring of thoughts, feelings, and body sensations (15 minutes). BMBI participants will be encouraged to practice the taught mindfulness technique at home at least 20 minutes/day for 1 week (a handout and link to an online guided mindfulness practice will be provided).
15911269|NCT03563911|Behavioral|Control/Nutrition Education|The Control intervention will involve nutrition education, adapted from an existing manual of cognitive-behavioral therapy for opioid-treated chronic pain. Control intervention protocol will match the BMBI in terms of time / structure to control for the non-specific, non-mindfulness effects of BMBI. The 20-minute Control session will include education on the relationship between diet and pain (10 minutes) and recommendations for a healthy diet (10 minutes). Control participants will be encouraged to prepare healthy meals at home at least 20 minutes/day for 1 week (a handout and link to online resources will be provided).
15911270|NCT03563898|Other|Sweating with Portable Sauna Bath|Patients will be subjected daily for 30 minutes to the Portable Sauna Care steam bath (45 degree C temperature). The patient will decide if the time and / or temperature of the Sauna Bath is reduced to Tolerance. Before being subjected to the sauna bath, blood pressure will be taken 10 minutes prior. Weigh the patient with a Scale. You will be informed of the symptoms that may occur during the bath, and if present, you will let the health staff know that you will be present at all times during the bathing period, which will have a SURVEILLANCE TABLE which It will be filled during the intervention where they are monitored and comply with the stipulated norms as well as notes for adverse effects. After the completion of the bath, there will be a space of 15 minutes for the patient to dry the skin and the bathing suit with a towel. After 15 minutes, the patient will be weighed and the blood pressure will be taken again.
15911271|NCT03563885|Procedure|bariatric surgery|subjects already scheduled Roux-en-Y gastric bypass (RYGB) or sleeve gastrectomy (SG) surgery
15911272|NCT03563872|Other|Intervention|Enhancements to team-based care include clinical decision support and improved protocols for telehealth prescribing.
15911273|NCT03563872|Other|Active Comparator|Usual, team-based care
15911274|NCT03563846|Drug|RP-G28|RP-G28 is a purified galacto-oligosaccharide (GOS) product
15911275|NCT03563833|Other|Minimal Flow Anesthesia|Minimal Flow Anesthesia with 0,4 L min-1
15911276|NCT03563833|Other|High Flow Anesthesia|High Flow Anesthesia with 2 L min-1
15911277|NCT03563820|Behavioral|Resilience and Well-Being Program|"The Resilience and Well-Being Program is offered through VA Puget Sound Rehabilitation Care Services as part of standard clinical care offerings. The program includes five (5) positive psychology group sessions once a week for five weeks. Participants will use strengths-based strategies, narrative strategies, and prospective strategies to learn ways to deal with stressful life challenges and improve their mental health and well-being.
~Each participant will be given a brief rating sheet at the end of each session to fill out. The rating sheet will ask participants to rate different aspects of the session (e.g., how helpful or interesting the session was to the participant), if home practice activities were assigned, whether the participant completed the home practice assignment, as well as feedback to improve that session."
15911278|NCT03563807|Other|Golf Instruction|Subjects will participate in two weekly hour-long golf classes. Classes will be led by professional golf instructors that will work with individuals to teach participants how to play golf. This will include stretching, individual coaching, and working with participants to maximize their golf swing.
15911279|NCT03563807|Other|Tai Chi Class|Tai Chi is an ancient martial art that uses meditative movement to improve strength, flexibility, and balance. Subjects will participate in two weekly hour-long Tai Chi classes.The class will be led by a certified Tai Chi instructor and consist of approximately 12 people.
15911280|NCT03563794|Drug|CSII+Vildagliptin|Vildagliptin(50mg b.i.d po.) will be added to Continuous Subcutaneous Insulin Infusion(insulin Lispro) treatment in T2DM. Doses of insulin Lispro will be instructed on a titration schedule, adjusted every 2 days.
15911281|NCT03563794|Drug|CSII(insulin Lispro)|T2DM patients will receive Continuous Subcutaneous Insulin Infusion(insulin Lispro) treatment. Doses of insulin Lispro will be instructed on a titration schedule, adjusted every 2 days.
15911282|NCT03563781|Procedure|Sentinel node detection|Patients will receive injection of tracer in the ovarian ligaments to identify the lymphatic drainage of the affected ovary and ultimately the sentinel node. Afterwards, systematic lymphadenectomy will be accomplished according to current guidelines.
15911283|NCT03563768|Procedure|One-stop strategy group|Percutaneous coronary intervention (PCI) will be performed on the same operating table immediately after the endovascular aortic repair (EVAR)
15911284|NCT03563755|Other|Cognitive Bias Modification|CBM-Attention (CBM-A) will be used with the aim of ameliorating negative cognitive biases in attention by redirecting attention towards positive social stimuli (accepting faces). Similarly CBM-Interpretation (CBM-I) will be used to ameliorate negative interpretation bias, by reinforcing benign outcomes of ambiguous social scenarios. Implementation intentions will be used to guide participants in planning new ways to face difficult social situations involving the risk of social rejection/criticism. Participants will continue to receive their usual treatment.
15911285|NCT03563742|Drug|Rilpivirine 25 mg|Participants will receive rilpivirine 25 mg tablet orally once daily.
15911286|NCT03563742|Drug|Tenofovir Disoproxil Fumarate (TDF)/Lamivudine (3TC)|Participants will receive 1 fixed dose combination tablet once daily containing 300 mg TDF and 300 mg 3TC.
15911287|NCT03563729|Drug|Pembrolizumab Injection [Keytruda]|Alone
15911288|NCT03563729|Drug|Ipilimumab Injection [Yervoy]|In combination with nivolumab.
15911289|NCT03563729|Drug|Nivolumab Injection [Opdivo]|In combination with ipilimumab.
15911290|NCT03563729|Drug|Encorafenib|In combination with binimetinib
15911291|NCT03563729|Drug|Binimetinib|In combination with encorafenib
15911292|NCT03563729|Drug|Dabrafenib|In combination with dabrafenib
15911293|NCT03563729|Drug|Trametinib|In combination with trametinib
15911294|NCT03563716|Drug|Atezolizumab|Atezolizumab at a fixed dose of 1200 mg will be administered first by IV infusion Q3W on Day 1 of each 21-day cycle.
15911295|NCT03563716|Drug|Tiragolumab|Tiragolumab at a fixed dose of 600 mg will be administered by IV infusion Q3W on Day 1 of each 21-day cycle.
15911300|NCT03563690|Other|treatment2|"Acupoints：Needling points are the same to the above group
~operation: The electrode will be connected Neixiyan (EX-LE4) and Dubi (ST35) and electrode wire will be connected to the electro-acupuncture apparatus using dilatational wave with a frequency of 2/100 Hz, the current intensity is within participants'tolerance, for 30 minutes."
15911301|NCT03563690|Other|treatment3|"Acupoints：treating points are the same to the above group
~Operation: During treatment, participants will choose to sit with knee buckling natural 90 degrees ,with the affected knee(s) exposed. Mild moxibustion are applied at the distance of 2-3 cm away from the skin of both the Neixiyan (EX-LE4) and Dubi (ST35) for 30 minutes."
15911302|NCT03563690|Other|treatment4|"Acupoints：Needling points are the same to the above group
~Operation: Warm-needling acupuncture are applied at both Neixiyan (EX-LE4) and Dubi (ST35). That is to insert one zhuang(about 2cm)of Huai Qing Ai on the top of the needle, and burn the moxa at the lower end ,each acupoint applied 2 Zhuang for 30 minutes."
15911303|NCT03563690|Other|treatment5|"points：Sham Liangqiu（ST34）,Sham Xuehai(SP10), Sham Neixiyan(EX-LE4), Sham Yanglingquan(GB34),Sham Yinlingquan (SP9)
~Operation: Sham acupuncture with non-meridian and non-acupoint needling method, respectively acupuncture 1cm away lateral to the above sham acupoints with a 0.18 * 25mm single-use needle with the depth of 1-2mm."
15911304|NCT03563690|Drug|Celebrex|Drug: Celebrex (Celebrex, Capsules, Pfizer Pharmaceuticals Ltd), which will be applied 1 time daily( taken 0.2g one time orally ) Time of treatment :4 weeks Other Name: celecoxib
15911305|NCT03563677|Other|dual expert guidance structure|Two medical experts, one somatic specialist and one psychiatrist/psychosomatic specialist see all medical records and the patients together
15911306|NCT03563664|Procedure|Pre-treatment endometrial biopsy|Timed suction endometrial biopsy was obtained from participants via Wallach Endocell® 908014A endometrial cell sampler timed during the implantation window of the pretreatment cycle; followed by immunohistochemical staining using immunoperoxidase staining incorporating avidin-biotin complex (ABC) method.
15911307|NCT03563664|Drug|Danazol|Participants were treated with danazol (Danol® 200mg capsules, Sanofi, Guildford, UK) in daily dosage of 400 mg for 12 weeks.
15911308|NCT03563664|Procedure|Post-treatment endometrial biopsy|Post-treatment suction endometrial biopsy was obtained during the implantation window following the first ovulation after danazol treatment, timed, processed and stained as described previously.
15911309|NCT03563651|Procedure|Biopsy|Undergo biopsy
15911310|NCT03563651|Procedure|Biospecimen Collection|Undergo collection of blood, urine, and stool
15911311|NCT03563651|Other|Laboratory Biomarker Analysis|Correlative studies
15911312|NCT03563651|Other|Questionnaire Administration|Ancillary studies
15911313|NCT03563638|Diagnostic Test|75gOGTT|oral glucose tolerance test (OGTT) was conducted on all participants between the 24th and 28th gestation weeks.The diagnosis of GDM is made when any of the following plasma glucose values are met or exceeded: FPG≥5.1 mmol/L and/or 1h-PG ≥10.0 mmol/L and/or 2h-PG ≥8.5 mmol/ L.
15911314|NCT03563625|Procedure|Caudal block|Caudal block/bupivacaine 0.25%
15911315|NCT03563625|Procedure|Wound infiltration|Local anesthetic wound infiltration/bupivacaine 0.25%
15911316|NCT03563625|Drug|Bupivacaine|bupivacaine
15911317|NCT03563612|Device|cpap|application of cpap to the non-dependent lung, during one lung ventilation
15911318|NCT03563599|Drug|Telacebec (Q203)|High, Mid, Low dose of telacebec
15911319|NCT03563599|Drug|Rifafour e-275|RHZE (R=rifampicin: H=isoniazid: Z=pyrazinamide: E=ethambutol)
15911320|NCT03563586|Other|Bowel Preparation plus antibiotics|Preoperative oral antibiotic therapy with rifaximin 400 mg plus metronidazole 500mg the day prior to surgery at 2:00, 3:00 and 10:00 pm, with mechanical bowel preparation (2 vials sodium phospate 45ml at 1:00 and 7:00 pm)
15911321|NCT03563586|Other|Bowel Preparation|Mechanical Bowel Preparation (2 vials sodium phospate 45ml at 1:00 and 7:00 pm) alone Both groups will receive iv antibiotics (cefoxitin 2 gr plus metronidazole 500gr) perioperatively and discontinuation within 24 hours
15911322|NCT03563573|Drug|Potassium Gluconate Oral Capsule|Each subject will receive a dose of ~8 mg/kg of potassium. We will be giving a maximum of 14 mEq in a single dose.
15911323|NCT03563573|Drug|Placebo oral capsule|Each subject will receive a dose of ~8 mg/kg of a placebo capsule
15911324|NCT03563560|Drug|Alvocidib|ACM regimen:30 mg/60 mg, 30-minute intravenous (IV) infusion, followed 4-hour IV infusion from Day 1 to Day 3 A+7+3 regimen: recommended dose (RD), 30-minute IV infusion, followed 4-hour IV infusion from Day 1 to Day 3
15911325|NCT03563560|Drug|Cytarabine|300 or 667 mg/m2/day, 72-hour continuous IV infusion starting on Day 6 (ACM regimen)
15911326|NCT03563560|Drug|Mitoxantrone|14 or 40 mg/m2/day, IV infusion over 1 hour to 2 hours at 12 hours after the end of DSP-AraC administration (acceptable range + 3 hours)
15911327|NCT03563560|Drug|Cytarabine|100 mg/m2/day, continuous IV infusion for 7 days from Day 5 to Day 11 (A+7+3 regimen)
15911328|NCT03563560|Drug|Daunorubicine|60 mg/m2/day, 30-minute IV infusion for 3 days from Day 5 to Day 7
15911329|NCT03563547|Behavioral|Dietary counseling (fat modifed diet)|Subjects in both groups had been instructed to achieve specific daily maximum intakes in total fat (≤ 30% of total energy intake), saturated fatty acids (≤10% of total fat intake) and cholesterol (≤ 300 mg). Furthermore the participating families had been trained to replace as many visible fat sources as possible with rapeseed oil due to its favorable composition of polyunsaturated fatty acids.
15911330|NCT03563547|Behavioral|Dietary Counseling (fat modified + soy enriched diet)|"Subjects in both groups had been instructed to achieve specific daily maximum intakes in total fat (≤ 30% of total energy intake), saturated fatty acids (≤10% of total fat intake) and cholesterol (≤ 300 mg). Furthermore the participating families had been trained to replace as many visible fat sources as possible with rapeseed oil due to its favorable composition of polyunsaturated fatty acids.
~Subjects allocated to the soy group and their families were additionally instructed to consume at least 0.25 g of soy protein per kg bodyweight per day and were provided with recipes and practical advice on how to achieve this goal. Example provided: a child with a bodyweight of 30kg would have to consume the equivalent of approx. 50g of Tofu per day to meet the treatment target."
15911331|NCT03563534|Drug|Silver Diamine Fluoride|Margins of cavitated lesion(s) will be excavated.The carious teeth will be isolated, kept dry, and apply 38% silver diamine fluoride.
15911332|NCT03563534|Drug|Glass Ionomer|Margins of cavitated lesion(s) will be excavated.The carious teeth will be isolated, kept dry, apply resin modified glass ionomer.
15911333|NCT03563495|Other|tissue engineered group|cultured and bone marrow derived autologous mesenchymal stem cells, loaded on collagen matrix (Osteovit)
15911334|NCT03563495|Procedure|autogenous bone graft group|
15911335|NCT03563482|Diagnostic Test|PET scan|Tumor biopsy at baseline; PET scan performed after 8 weeks of treatment
15911336|NCT03563469|Other|Salivary bacterial and pH level|"Saliva sample will be collection ask the patient to stop eating and drinking for one hour before collecting the sample,(2) Give the patient distilled water and ask them to rinse their mouth well for 1 min,five minutes after this oral rinse, ask the patient to spit into 50ml sterile tube, collect 5ml of saliva and return to the laboratory within an hour.
~The dental caries of all patients will also be recorded using dental mirror and explorer. The caries experience will be recorded in diagnostic chart using the World Health Organization (WHO) criteria for deciduous teeth and dmft caries index."
15911337|NCT03563456|Behavioral|structured combined exercise|A structured designed exercise consists of three times per week interval cardiorespiratory training of High Intensity Interval Training incorporates cycles of 1:4 interval and two times per week Resistance Exercise consists of nine-movement.
15911338|NCT03563456|Behavioral|cardiorespiratory exercise|Once per week continuous cardiorespiratory training of moderate intensity
15911339|NCT03563443|Diagnostic Test|Genomic Imprinting Testing|The changes of LOI The obtained LOI from morning urine and tumor will be tested by LiSen imprinting diagnostic (LSID)
15911340|NCT03563430|Other|Active Recovery Group|Participants in this group will exercise for 15 minutes, for a range of 65 to 70% of the maximum heart rate as a recovery method following a single bout high-intensity interval exercise program
15911341|NCT03563430|Other|Self-Massage with Foam Roller Group|This group will perform 15 minutes self-massage with foam roller following the exercise session as a recovery method following a single bout high-intensity interval exercise program.
15911342|NCT03563430|Other|Neuromuscular Electrical Stimulation|Participants of this group will be applied electrical stimulation on quadriceps femoris and hamstring muscles for 15 minutes while they are comfortable lying position as a recovery method following a single bout high-intensity interval exercise program.
15911345|NCT03563391|Other|New Infant Formula|New Infant Formula is a specialized, nutritionally complete, nutrient-dense infant formula specifically formulated for infants with growth failure.
15911346|NCT03563378|Drug|Lactated Ringer|Patients will be administered Lactated Ringer's solution for intraoperative fluid management.
15911347|NCT03563378|Drug|Normal saline|Patients will be administered normal saline for intraoperative fluid management.
15911348|NCT03563365|Other|Replenix Power of 3 Cream with resveratrol|Cosmetic product containing Green Tea Polyphenols, Resveratrol, Caffeine USP, Bisabolol Cucumber extract, Chamomile extract, Rosemary extract, Squalane, Soy Phospholipids
15911349|NCT03563365|Drug|Adapalene and Benzoyl peroxide gel, 0.1%/2.5%|FDA approved topical agent for the treatment of acne
15911350|NCT03563352|Other|Interview|Attend an interview
15911351|NCT03563352|Other|Survey Administration|Ancillary studies
15911352|NCT03563339|Behavioral|P-POD|. P-POD will include seven 30-minute online, educational, interactive modules that teach at-risk pregnant women skills derived from the gold standard, empirically supported cognitive-behavioral treatment for anxiety disorders and OCD. Additionally, P-POD will include three modules for fathers, to help them support their partners during the postpartum period. We will modify P-POD from an already existing in-person prevention program for postpartum OCD (developed by Co-Investigator Kiara Timpano). The m-health foundation of P-POD will be an already existing Internet-delivered treatment infrastructure (OurRelationship.com, developed by Co-Investigator Brian Doss).
15911353|NCT03563326|Biological|CAR-T cells targeting EpCAM|Biological: CAR-T cells targeting EpCAM
15911354|NCT03563326|Biological|Chemotherapy|Chemotherapy: determined by medical Oncologist
15911355|NCT03563313|Device|t:slim X2 with Control-IQ Technology & Dexcom G6 CGM|Participants will use the Tandem t:slim X2 with Control-IQ Technology & Dexcom G6 CGM for 6 months at home.
15911356|NCT03563313|Device|Sensor-augmented pump (SAP)|Participants will use an insulin pump with no automated insulin delivery and a study CGM (Dexcom G6) for 6 months at home. Pump-users at the time of enrollment will use their personal pump in this arm. Multiple daily injection (MDI) users at the time of enrollment will use a t:slim X2 insulin pump without Control-IQ technology.
15911357|NCT03563300|Other|Wheat flour|Wheat flour will be administered once daily for 7 days
15911358|NCT03563300|Other|Placebo Comparator|Placebo will be administered blindly versus wheat flour for 7 days
15911359|NCT03563287|Drug|cocktail of nine CYP probe drugs|"Two equally loaded capsules containing:
~Melatonin (2.0 mg) Nicotine (1.0 mg) Bupropion (37.5 mg) Repaglinide (0.25 mg) Losartan (12.5 mg) Omeprazole (10 mg) Chlorzoxazone (62.5 mg) Midazolam (1.85 mg) Dextromethorphan (30 mg) as an oral solution was administered separately after the capsules."
15911360|NCT03563274|Device|Selective Internal Radiation Therapy with QuiremSpheres®|The main purpose of this study is to further assess treatment efficacy and safety after using QuiremSpheres® for the treatment of patients with unresectable primary liver cancer or unresectable liver metastases suitable for SIRT and allocated to this treatment by a multidisciplinary tumor board.
15911361|NCT03563261|Dietary Supplement|Collagen supplement group|Participants from both group will take their supplement every morning prior to breakfast. Supplementation period will be 4 months. They will perform tendons loading activities 30 minutes after ingestion of the supplement. Tendons loading activities will be heel raises and knee extensions while seated. Participants will be asked to keep the exercise intensity low as it is not a strengthening intervention.
15911362|NCT03563261|Dietary Supplement|Placebo supplement group|Participants from both group will take their supplement every morning prior to breakfast. Supplementation period will be 4 months. They will perform tendons loading activities 30 minutes after ingestion of the supplement. Tendons loading activities will be heel raises and knee extensions while seated. Participants will be asked to keep the exercise intensity low as it is not a strengthening intervention.
15911416|NCT03563144|Biological|ALT-803|Recombinant human super agonist interleukin-15 (IL-15) complex
15911417|NCT03563144|Biological|ETBX-011|Ad5 [E1-, E2b-]-CEA
15911418|NCT03563144|Biological|ETBX-021|Ad5 [E1-, E2b-]-human epidermal growth factor receptor 2 [HER2] vaccine
15911363|NCT03563248|Drug|FOLFIRINOX|"FOLFIRINOX is a combination of 4 chemotherapy agents that may help shrink your tumor before surgery
~5-Fluorouracil (5-FU) - 400 mg/m2 on day one, followed by 1200 mg/m2 by continuous infusion for the subsequent 46-48 hours
~Oxaliplatin - 85 mg/m2 by intravenous infusion over 120 minutes on day 1 of each 14 day cycle
~Irinotecan - administered at a starting dose of 180 mg/m2 by intravenous infusion over 90 minutes on day 1 of each 14 day cycle
~Leucovorin - Administered at a starting dose of 400 mg/m2 over 2 hours on day 1 of each 14 day cycle"
15911364|NCT03563248|Drug|Losartan|Losartan is a drug that is used to lower blood pressure
15911365|NCT03563248|Drug|Nivolumab|Nivolumab is an antibody that may cause programmed cell death of cancer cells
15911366|NCT03563248|Radiation|SBRT|Radiation therapy is believed to increase the likelihood of response of immunotherapy
15911367|NCT03563248|Procedure|Surgery|definitive surgical resection
15911368|NCT03563235|Drug|Xulin Jiangu granules|Xulin Jiangu granules tablets
15911369|NCT03563235|Drug|Calcitriol capsules|Calcitriol capsules tablets
15911370|NCT03563222|Drug|Smoflipid|"The study drugs will be infused via a dedicated line for parenteral nutrition (PN) into a central vein using a central venous catheter or a peripherally inserted central catheter.
~The initial rate of infusion should be no more than 0.05 mL/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.5 mL/kg/hour.
~The individual dosage of study drug should be infused at a constant rate for 10 to 24 h/d. The administration flow rate is determined by dividing the volume of study drug by the duration of the infusion. Maximum infusion rate for lipid should not exceed 0.125 g/kg/h lipid.
~Study drug infusions should be given 5 to 7 days per week. Study treatment will last for a minimum of 90 consecutive days and as long as PN is indicated, up to 365 consecutive days. If the indication for PN continues after Study Day 365, PN will continue per normal institution policy."
15911371|NCT03563222|Drug|Intralipid, 20%|"The study drugs will be infused via a dedicated line for parenteral nutrition (PN) into a central vein using a central venous catheter or a peripherally inserted central catheter.
~The initial rate of infusion should be no more than 0.05 mL/minute for the first 10 to 15 minutes. If no untoward reactions occur, the rate can be changed to permit infusion of 0.5 mL/kg/hour.
~The individual dosage of study drug should be infused at a constant rate for 10 to 24 h/d. The administration flow rate is determined by dividing the volume of study drug by the duration of the infusion. Maximum infusion rate for lipid should not exceed 0.125 g/kg/h lipid.
~Study drug infusions should be given 5 to 7 days per week. Study treatment will last for a minimum of 90 consecutive days and as long as PN is indicated, up to 365 consecutive days. If the indication for PN continues after Study Day 365, PN will continue per normal institution policy."
15911372|NCT03563196|Radiation|Chest Radiograph|Chest radiogram will be obtained on day 1
15911373|NCT03563196|Diagnostic Test|Lung Ultrasound|Lung ultrasound will be done on day 1
15911374|NCT03563183|Other|Encoding of data collected in Zoster 006 and Zoster 022 studies|Not applicable (disease epidemiology study)
15911375|NCT03563170|Biological|ETBX-011|Ad5 [E1-, E2b-]-CEA
15911376|NCT03563170|Biological|GI-4000|Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant RAS proteins
15911377|NCT03563170|Biological|haNK for infusion|NK-92 [CD16.158V, ER IL-2]
15911378|NCT03563170|Biological|avelumab|Recombinant human anti-PD-L1 IgG1 monoclonal antibody
15911379|NCT03563170|Drug|Capecitabine|5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine
15911380|NCT03563170|Drug|Cyclophosphamide|anhydrous
15911381|NCT03563170|Drug|5-Fluorouracil|5-FU; Fluorouracil
15911382|NCT03563170|Drug|Leucovorin|Leucovorin calcium salt
15911383|NCT03563170|Drug|nab-Paclitaxel|ABRAXANE® [paclitaxel protein-bound particles for injectable suspension] [albumin-bound]
15911384|NCT03563170|Drug|Sorafenib|NEXAVAR® tablets, for oral use
15911385|NCT03563170|Procedure|SBRT|Stereotactic Body Radiation Therapy
15911386|NCT03563170|Biological|Aldoxorubicin hydrochloride|HCl
15911387|NCT03563170|Biological|ETBX-051|Ad5 [E1-, E2b-]-Brachyury vaccine
15911388|NCT03563170|Biological|ETBX-061|Ad5 [E1-, E2b-]-mucin 1 [MUC1] vaccine
15911389|NCT03563170|Biological|GI-6207|CEA yeast vaccine
15911390|NCT03563170|Biological|GI-6301|Brachyury yeast vaccine
15911391|NCT03563170|Drug|Cetuximab|ERBITUX® injection, for IV infusion)
15911392|NCT03563170|Biological|N-803|Recombinant human super agonist IL-15 complex [also known as IL-15N72D:IL- 15RαSu/IgG1 Fc complex]
15911393|NCT03563157|Biological|Aldoxorubicin Hydrochloride|Aldoxorubicin Hydrochloride HCI
15911394|NCT03563157|Biological|ALT-803|Recombinant human super agonist interleukin-15 (IL-15) complex [also known as IL-15N72D;IL-15RaSu/IgG1 Fe complex1]
15911395|NCT03563157|Biological|ETBX-011|Ad5 [E1-, E2b-]-CEA
15911396|NCT03563157|Biological|ETBX-021|Ad5 [E1-, E2b-]-[HER2]
15911397|NCT03563157|Biological|ETBX-051|Ad5 [E1-, E2b-]-Brachyury
15911398|NCT03563157|Biological|ETBX-061|Ad5 [E1-, E2b-]-mucin 1 [MUC1]
15911399|NCT03563157|Biological|GI-4000|RAS yeast
15911400|NCT03563157|Biological|GI-6207|CEA yeast
15911401|NCT03563157|Biological|GI-6301|Brachyury yeast
15911402|NCT03563157|Biological|haNK|haNK™, NK-92 [CD16.158V, ER IL-2]
15911403|NCT03563157|Drug|Avelumab|BAVENCIO® injection
15911404|NCT03563157|Drug|Capecitabine|XELODA® tablets
15911405|NCT03563157|Drug|Cetuximab|ERBITUX® injection
15911406|NCT03563157|Drug|Cyclophosphamide|Cyclophosphamide Capsules
15911407|NCT03563157|Drug|5-Fluorouracil|5-FU; Fluorouracil Injection
15911408|NCT03563157|Drug|Leucovorin|Leucovorin Calcium
15911409|NCT03563157|Drug|Nab-paclitaxel|ABRAXANE® for Injectable Suspension [paclitaxel protein-bound particles for injectable suspension] [albumin-bound]
15911410|NCT03563157|Drug|Oxaliplatin|ELOXATIN® injection
15911411|NCT03563157|Drug|Regorafenib|STIVARGA® tablets
15911412|NCT03563157|Procedure|SBRT|Stereotactic body radiation therapy
15911413|NCT03563144|Drug|Gemcitabine|Gemcitabine is a type of chemotherapy medication used to interfere with the cancer cells' ability to grow and divide.
15911414|NCT03563144|Drug|Nab-paclitaxel|NAB-paclitaxel is a type of chemotherapy called a microtubule inhibitor. Microtubule inhibitors interfere with a cancer cell's ability to grow and divide.
15911415|NCT03563144|Drug|Aldoxorubicin HCl|Albumin-binding prodrug of doxorubicin HCl
15911428|NCT03563144|Drug|Cyclophosphamide|2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
15911429|NCT03563144|Drug|5-Fluorouracil|5-fluoro-2,4 (1H,3H)-pyrimidinedione
15911430|NCT03563144|Drug|Leucovorin|L-Glutamic acid, N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-, calcium salt
15911431|NCT03563144|Drug|Oxaliplatin|Oxaliplatin
15911432|NCT03563131|Device|Persona® total knee arthroplasty|Insertion of the cemented or uncemented Persona® total knee arthroplasty
15911433|NCT03563105|Device|The Ox-Imager Mini (Desaturation)|Vascular Occlusion Test
15911434|NCT03563092|Procedure|Laparoscopic Inguinal Hernia (TEP/TAPP) Surgery|Standardized minimally invasive approach to inguinal hernia repair
15911435|NCT03563079|Other|Instrument Assisted Soft Tissue Mobilization|Soft Tissue Mobilization
15911436|NCT03563079|Other|Manual Myofascial Release|Myofascial Release Technique
15911439|NCT03563053|Combination Product|EryDex System|EryDex System is a combination product that is used to load dexamethasone sodium phosphate (DSP) into autologous erythrocytes (EDS) creating the EDS-end product which is infused into the patients
15911440|NCT03563040|Drug|Methoxsalen|"Methoxsalen is used in conjunction with the THERAKOS CELLEX Photopheresis System.
~During each photopheresis treatment with methoxsalen, the dosage of methoxsalen is calculated according to the treatment volume (which is displayed on the display panel of the instrument) using the formula:
~Treatment volume x 0.017 ml of methoxsalen (20 µg/mL) for each treatment For example: Treatment volume = 240 mL x 0.017 = 4.1 mL of methoxsalen (20 µg/mL)"
15911441|NCT03563040|Device|THERAKOS CELLEX Photopheresis System|Methoxsalen is used in conjunction with the THERAKOS CELLEX Photopheresis System.
15911442|NCT03563027|Behavioral|Social Incentive Gamification|Game-based intervention with points and levels
15911443|NCT03563027|Behavioral|Support Sponsor|Participants select a support sponsor to receive weekly updates on progress in the game
15911444|NCT03563027|Behavioral|Financial Incentive|Participants receive a loss-framed financial incentive allocated upfront each week and financial incentives taken away each day the goal is not met
15911445|NCT03563014|Drug|Radium-223 (Xofigo, Bay88-8223)|Follow the physician's prescription in routine clinical practice.
15911446|NCT03563001|Drug|Budesonide(160ug) and Formoterol(4.5ug) bid|For both groups of subjects,small airways function of is assessed at baseline.And then budesonide(160ug) and formoterol(4.5ug) bid will be given to the subjects for 3 months.The subjects will have a follow-up visit with the same examinations after 3 months' treatment.
15911447|NCT03562988|Dietary Supplement|Vitamin C gummy|vitamin C
15911448|NCT03562988|Dietary Supplement|Vitamin C tablet|vitamin C
15911449|NCT03562975|Drug|Ocrelizumab|Ocrelizumab is a humanized anti-CD20 monoclonal antibody. It targets CD20 marker on B lymphocytes and hence is an immunosuppressive drug candidate. Ocrelizumab binds to an epitope that overlaps with the epitope to which rituximab binds
15911450|NCT03562962|Behavioral|Functional Analytic Psychotherapy|FAP is a therapeutic procedure based on behavior analytic principles. This approach seeks to implement procedures to manipulate the contingencies of reinforcement involved in clients' problem and alternative behaviors within the context of a meaningful therapeutic relationship that is functionally equivalent to other interpersonal contexts outside (Follette, Naugle & Linnerooth, 2000; Kohlenberg & Tsai, 1991). FAP therapists modify CRBs by implementing contingent responding (TCRB) within the therapeutic setting. That is, FAP aims to administer differential reinforcement (TCRB1) to reduce CRB1s and to provide positive reinforcement to enhance CRB2s. Based on the changes within the therapeutic setting, clients are prompted to discriminate contexts where those repertoires are likely reinforced and to generalize those responses to such environments (Kohlenberg & Tsai, 1991).
15911451|NCT03562949|Drug|Test Product|Beclomethasone Dipropionate Inhalation Aerosol, 40 mcg
15911452|NCT03562949|Drug|Reference Product|QVAR® 40 mcg (Beclomethasone Dipropionate HFA)
15911453|NCT03562949|Drug|Placebo|Placebo Product
15911454|NCT03562923|Drug|Test Product|Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder
15911455|NCT03562923|Drug|Reference Product|ADVAIR DISKUS® 100/50 (Fluticasone Propionate 100 mcg and Salmeterol 50 mcg Inhalation Powder)
15911456|NCT03562923|Drug|Placebo|Placebo Product
15911457|NCT03562910|Other|HelpSteps application|Mobile or tablet-based tool that screens for social needs and refers to local agency based on needs and proximity.
15911459|NCT03562884|Drug|BLI800|Two bottles of BLI800 are needed for appropriate cleansing of the bowel. Prior to administration, the content of each bottle must be diluted in water, using the cup provided, to a total volume of approximately 0.5 L, and must be followed by the ingestion of 1 additional litre of water.
15911460|NCT03562884|Drug|Fortrans®|Fortrans® (Powder for Oral Solution) will be given according to Chinese approved Summary of Product Characteristics (SmPC). Fortrans® is provided as a powder for Polyethylene Glycol (PEG) based solution available in sachets containing a white powder readily miscible with water. The dosing for Fortrans® administration will be adapted to subjects' body weight as following: 1 L of solution for 15 to 20 kg, an average of 3 to 4 L (maximum 4 L).
15911461|NCT03562871|Biological|IO102|test immunotherapy
15911462|NCT03562871|Biological|pembrolizumab (Keytruda)|anti-PD-1 immunotherapy
15911463|NCT03562871|Drug|Carboplatin (Carboplatin Kabi)|chemotherapy
15911464|NCT03562871|Drug|Pemetrexed (Pemetrexed Alvogen)|chemotherapy
15911465|NCT03562858|Procedure|Immediate dentin sealing protocol|Sealing of the dentin before impression taking directly after cavity preparation to prevent postoperative hypersensitivity during provisionalization and after cementation
15911466|NCT03562858|Procedure|Delayed dentin sealing protocol|Sealing the dentin just prior to cementation
15911467|NCT03562845|Other|NA-Observational only|NA-Observational only
15911468|NCT03562832|Drug|PARP inhibitor 2X-121|600 mg PARP inhibitor 2X-121 as single daily oral agent in mBC patients
15911469|NCT03562806|Diagnostic Test|PET/MR image acquisition|Acquisition of PET and MR sequences on SIGNA PET/MR device.
15911470|NCT03562793|Behavioral|Communication and Activation in Pain to Enhance Relationships and Treat Pain with Equity (COOPERATE)|. COOPERATE seeks to improve patient activation in minority Veterans with chronic pain by focusing on two major skill sets: 1) goal clarification and prioritization, and 2) communication skills (Table 1). By understanding, clarifying, and prioritizing goals, and having the skills to communicate their goals, priorities, and preferences to providers, Veterans will gain knowledge, confidence, and skills to be actively involved in managing their chronic pain. The intervention consists of 6 total sessions delivered individually over 12 weeks: 4 sessions focused on teaching skills related to goal clarification/prioritization and communication (30-minutes each), delivered weekly for the first 4 weeks, plus 2 booster sessions (20-25 minutes each) delivered once per month for the next 2 months.
15911471|NCT03562780|Drug|Fortolin Tab 500mg|Fortolin Tab 500mg is a generic product manufactured by Fortune Pharmacal Co. Ltd.
15911472|NCT03562780|Drug|Panadol Caplet 500mg|Panadol Caplet 500mg is manufactured by GlaxoSmithKline (Dungarvan) Ltd.
15911473|NCT03562767|Behavioral|Group-based Cognitive Behavioral Intervention|This intervention will include six 1-hour group sessions held biweekly for twelve weeks. Each sixty-minute session will consist of 15 minutes of diabetes education regarding exercise and food planning and approximately 45 minutes of CT-CB presentations/engagement activities. Participants will be encouraged to bring along their family members or friends for support.
15911474|NCT03562767|Behavioral|Web-based Cognitive Behavioral Intervention|This intervention will include six 1-hour web-based sessions held biweekly for twelve weeks. Subjects in the web-based CT-CB will be asked to reserve a 1 hour period for a web call from the Behavioral Interventionist team. Text reminders will be sent to the participants prior the sessions. During this period, approximately 15 minutes will be reserved for diabetes exercise and food planning education and approximately 45 minutes of CT-CB engagement activities.
15911475|NCT03562767|Behavioral|Usual Care|Usual care group participants will continue to receive care and follow up from their primary care providers as per the American Diabetes Association guidelines with log books, education regarding self-management strategies and appropriate referrals as needed.
15911476|NCT03562754|Procedure|reduced systemic heparin anticoagulation|receive intermittent hemodialysis (Frésenius 4008) with blood flow at least of (200 ml/min) with double vascular access, biocompatible membrane dialyzer, low dose non fractionated heparine (5000 UI initially) and predilution with 25 mls/min dialysate
15911477|NCT03562754|Procedure|Regional Citrate Anticoagulation|intermittent hemodialysis using Prometheus System with blood flow at least of 200 ml/min with double vascular access, biocompatible membrane dialyzer
15911478|NCT03562741|Procedure|Fecal Microbiota Transplantation|Transplantation of Screened donor stool as part of Fecal Microbiota Transplantation
15911479|NCT03562728|Device|MRP and NMES(neuromuscular electric stimulation)|nutrition supplementation includes addition of essential amino acids 3 times a day to feeding
15911480|NCT03562728|Other|Standard of Care|Patients in the control group are going to receive standard of care
15911481|NCT03562702|Other|Standard IV Rehydration Therapy|IV rehydration group receiving a Normal Saline bolus of IVF (usually 20 ml/kg)
15911482|NCT03562702|Other|Oral Rehydration Therapy (ORT)|Speedlyte oral solution as rehydration therapy based on participant's weight (10 m/l kg over one hour). Total of 150 ml/kg over 24 hours prior to discharge
15911483|NCT03562689|Other|Delirium and with septic encephalopathy.|Delirium or septic encephalopathy survivors will be analized in the same way: Cognitive tests, EEG and MRI.
15911484|NCT03562676|Other|weightlessness|parabolic flight
15911485|NCT03562663|Device|Transcranial direct current stimulation|A constant, low current stimulation is provided non-invasively through sponge electrodes positioned over the motor cortex of the affected arm. The stimulation is provided for 20 minutes at an intensity of 2 mA.
15911486|NCT03562663|Device|Upper extremity robotics|Participants complete robotic training 3 days per week for 12 weeks, or 36 sessions. The protocol alternates between planar (shoulder/elbow) and wrist robots for the duration of the study.
15911487|NCT03562650|Behavioral|Safety Behavior Fading|Participants are asked to fade their three most common safety behaviors associated with their social anxiety
15911488|NCT03562650|Behavioral|Present Centered|Participants are asked to try to increase their focus on the present.
15911489|NCT03562637|Biological|adagloxad simolenin combined with OBI-821|In the neoadjuvant and adjuvant phases of the study for a total of 100 weeks; subcutaneously injections.
15911490|NCT03562637|Device|Globo H IHC Assay|The Globo H IHC assay will be used to identify eligible patients who may clinically benefit from the OBI-822 treatment, defined by Globo H expression.
15911491|NCT03562637|Other|Standard of care treatment|Standard of care treatment consisting of observation alone, adjuvant capecitabine or platinum monotherapy over a 100 week period.
15911492|NCT03562624|Drug|BAY98-7443|"Active ingredient content (in mg IND/LNG):
~low dose 6.5 / 13.5; middle dose 12.5 / 13.5; high dose 15.4 / 13.5"
15911493|NCT03562624|Drug|Levonogestrel (Skyla, BAY86-5028)|Comparative LNG dose
15911494|NCT03562611|Drug|Nalbuphine|Nalbuphine administration during surgery
15911495|NCT03562611|Drug|Flurbiprofen Axetil|Flurbiprofen axetil administration during surgery
15911496|NCT03562611|Drug|Nalbuphine and Flurbiprofen Axetil|Nalbuphine and Flurbiprofen Axetil administration during surgery
15911497|NCT03562585|Diagnostic Test|with sandwich ELISA immunoassay with fluorescence labeled monoclonal antibodies|with sandwich ELISA immunoassay with fluorescence labeled monoclonal antibodies
15911498|NCT03562572|Procedure|Ischemia driven revascularization|In the ischemia driven complete revascularisation strategy group all flow limiting (FFR ≤ 0.80) lesions will receive treatment by PCI and stenting during the index intervention
15911499|NCT03562572|Other|Usual care group|In the randomised to usual care group the procedure will stop after the PCI of the culprit artery and the patient will be referred to his treating cardiologist and/ or heart team who will decide whether a staged PCI of the non- IRA artery should take place. If the treating cardiologist (after advise of the heart team) decides to perform the non-IRA PCI revascularisation, than such treatment should take place within six weeks from the primary PCI in order to count as a scheduled staged PCI procedure.
15940379|NCT03338543|Device|TENS|transcutaneous electrical nerve stimulation
15911500|NCT03562559|Other|Measurements Using Ultrasound|Ultrasound measurements will be made in 5 positions. The ultrasound probe will be measuring from a fixed external location of the thigh. The 5 positions include: external rotation, neutral, manual tissue external rotation, straight leg raise at 30 degrees and hip/knee flexion at 90 degrees.
15911501|NCT03562546|Other|Strength From Within|A 12 week at home structured resistance exercise programme using resistance bands. Participants will also receive a walking programme, a warm up and cool down, and ankle range of motion exercises.
15911502|NCT03562533|Drug|pegylated liposomal doxorubicin (PLD) + carboplatin (CD)|carboplatin AUC 5 plus paclitaxel 175 mg/m2 every 3 weeks for at least 6 cycles
15911503|NCT03562533|Drug|carboplatin + paclitaxel (CP)|carboplatin AUC 5 plus paclitaxel 175 mg/m2 every 3 weeks for at least 6 cycles
15911504|NCT03562520|Behavioral|Behavior change counseling|"Core modules: 1 psychoeducation session at week 0; 4 behavior change counseling (BCC) sessions will occur at weeks 0, 4, 8, and 12; phone calls and/or texting sessions (weeks 1-3, 5-7, 9-11, and booster calls and/or texts on weeks 16 and 20) from therapists.
~Optional modules: Exercise coaching sessions; family involvement options will include participation in any aspect of the intervention; peer support options will include: group exercise classes on site, online Fitbit groups where adolescents can participate in competitions with each other and provide motivational support, and fitness support groups facilitated by registered social workers."
15911505|NCT03562507|Drug|ESK981|ESK981: 160 mg (4 capsules) PO daily for 5 consecutive days followed by a 2-day off drug in each week, repeated weekly in 4-week (28-day) cycles
15911506|NCT03562507|Drug|Nivolumab|480 mg/dose IV, Day 1 of each 28-day cycle
15911507|NCT03562494|Biological|VY-AADC02|Adeno-associated viral vector serotype 2 encoding human aromatic L-amino acid decarboxylase (AAV2- hAADC) infusion into the brain
15911508|NCT03562494|Other|Sham (Placebo) Surgery|Bilateral partial burr/twist holes without dura penetration
15911509|NCT03562481|Drug|1% Buffered Lidocaine 1:100,000 Epinephrine|A single IAN block with 3cc 1% Buffered Lidocaine (30mg) 1:100,000 Epinephrine using the Halstead technique.
15911510|NCT03562481|Drug|2% Unbuffered Lidocaine 1:100,000 Epinephrine|A single IAN block with 3cc 2% Unbuffered Lidocaine (60mg) 1:100,000 Epinephrine using the Halstead technique.
15911511|NCT03562468|Dietary Supplement|300 mg/day of TRU NIAGEN (nicotinamide riboside)|Treatment with 300 mg/day of TRU NIAGEN (nicotinamide riboside) will be administered daily as 4 capsules in a double-blind, randomized, crossover manner for three 8-week treatment periods. Each subject will receive one placebo and two active treatments in a crossover design. The two active treatments are 300 mg/d TRU NIAGEN (nicotinamide riboside) and 1000 mg/d TRU NIAGEN (nicotinamide riboside).
15911512|NCT03562468|Dietary Supplement|1000 mg/day of TRU NIAGEN (nicotinamide riboside)|Treatment 1000 mg/day of TRU NIAGEN (nicotinamide riboside) will be administered daily as 4 capsules in a double-blind, randomized, crossover manner for three 8-week treatment periods. Each subject will receive one placebo and two active treatments in a crossover design. The two active treatments are 300 mg/d TRU NIAGEN (nicotinamide riboside) and 1000 mg/d TRU NIAGEN (nicotinamide riboside).
15911513|NCT03562468|Dietary Supplement|Placebo|Treatment with placebo capsules will be administered daily as 4 capsules in a double-blind, randomized, crossover manner for three 8-week treatment periods. Each subject will receive one placebo and two active treatments in a crossover design. The two active treatments are 300 mg/d TRU NIAGEN (nicotinamide riboside) and 1000 mg/d TRU NIAGEN (nicotinamide riboside).
15911514|NCT03562455|Other|VRSim 3.0|VRSim 3.0 is a virtual reality training module.
15911515|NCT03562455|Behavioral|In-Person Wheelchair Training|A therapist will be used to train power wheelchair users.
15911516|NCT03562442|Behavioral|Smoking cessation|Smoking cessation with or without professional / medical support
15911517|NCT03562429|Drug|TGF|TGF is a powder formulation of Hu-Qian Wan (HQW). HQW is composited of 10 herbs, Chinemys reevesii (Gray), Phellodendron chinense Schneid., Achyranthes bidentata Blume, Anemarrhena asphodeloides Bunge, Rehmannia glutinosa Libosch., Paeonia lactiflora Pall., Cynomorium songaricum Rupr., Angelica sinensis (Oliv.) Diels, Citrus reticulata Blanco and Zingiber officinale Rosc..
15911518|NCT03562429|Drug|TGFP|TGFP is 1/20 concentration of Hu-Qian Wan (HQW). HQW is composited of 10 herbs, Chinemys reevesii (Gray), Phellodendron chinense Schneid., Achyranthes bidentata Blume, Anemarrhena asphodeloides Bunge, Rehmannia glutinosa Libosch., Paeonia lactiflora Pall., Cynomorium songaricum Rupr., Angelica sinensis (Oliv.) Diels, Citrus reticulata Blanco and Zingiber officinale Rosc..
15911519|NCT03562416|Drug|Nintedanib|Nintedanib (BIBF 1120, Ofev)
15911520|NCT03562416|Drug|Placebo Oral Tablet|Placebo
15911521|NCT03562403|Device|Deep Brain Stimulation|stimulation of different basal ganglionic nuclei by a inserting a device
15911522|NCT03562390|Drug|Irinotecan|The patients will receive treatment using intravenous irinotecan hydrochloride until the patient develops disease progression or fulfills a withdrawal criterion.
15911523|NCT03562377|Drug|Tralokinumab|Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous administration.
15911524|NCT03562377|Drug|Placebo|Placebo contains the same excipients in the same concentration only lacking tralokinumab.
15911525|NCT03562377|Biological|Tdap vaccine|Tetanus (lockjaw), diphtheria (infection of the nose and throat), and pertussis (whooping cough) vaccine. All subjects will receive 1 dose at Week 12.
15911526|NCT03562377|Biological|Meningococcal vaccine|This vaccine is used to prevent meningococcal diseases (infection of the brain and spinal cord) and blood poisoning. All subjects will receive 1 dose at Week 12.
15911527|NCT03562364|Other|AlterG anti-gravity treadmill|The AlterG treadmill is an FDA approved device that allows patients to perform early partial weight bearing exercises in a tightly controlled and safe environment
15911528|NCT03562351|Other|Verbal Instructions Educational Intervention|Caregivers will undergo training with verbal instructions
15911529|NCT03562351|Other|Video Educational Intervention|Caregivers will undergo training with an educational video
15911530|NCT03562351|Other|Mannequin Educational Intervention|Caregivers will undergo training with a mannequin
15911531|NCT03562338|Other|Manual Therapy and Exercise (Physiotherapy Intervention)|Participants in this group will receive a 6-weeks program of mobilization and progressive exercise for the neck flexors, 2 times a week.
15911568|NCT03562039|Procedure|M-MIST|minimal invasive surgical technique without thorough removal of granulation tissue
15911532|NCT03562338|Other|Usual Care (Physiotherapy Intervention)|Participants in this group will receive usual care in physiotherapy during the 6-weeks period.
15911533|NCT03562325|Behavioral|Acceptance and Commitment Therapy (ACT)|The main target in ACT for ME/CFS (as for Fibromyalgia and Chronic pain in previous studies by our group) is to promote a shift of perspective in life from symptom reduction (when it does not work) to a valued life. As such it entails acceptance and exposure to discomfort, in order to lessen the effects of negative experiences (symptoms, emotions, thoughts) on behaviours in everyday life.
15911534|NCT03562312|Other|high-intensive aerobe exercise|Aerobe bicycle ergometer training within 77-95% of maximum oxygen consumption; duration of each training session: 20 minutes; frequency of training: 6 sessions within 12 days
15911535|NCT03562312|Other|low-intensive aerobe exercise|Aerobe training below 70% of maximum oxygen consumption (including light stretching and simple exercises adapted from yoga figures); duration of training session: 20 minutes; frequency of training: 6 sessions within 12 days
15911536|NCT03562299|Device|OrthoPure™ XT|A decellularized, sterile, single use, xenograft device for reconstruction of the anterior cruciate ligament
15911537|NCT03562286|Procedure|Fetoscopy|Performing a minimally invasive procedure using a fetoscopic technique in order to access to amniotic cavity and make the endoscopic repair of the fetal neural tube defect.
15911538|NCT03562273|Radiation|Quality Of Life Sizing Nomogram|"If the participant meets the eligibility criteria of the study, and participant chooses to take part, they will receive the tumor bed boost in 8 Gy in 1 fraction just prior to starting whole breast radiation after joining the study. Treatment to the whole breast will begin within 7-8 days from the TB boost (GammaPodTM) treatment.
~The radiation therapy will take approximately 6 weeks to complete. Follow-up visits specifically for this study will continue for one year, although the physician will continue to follow as part of routine care."
15911539|NCT03562260|Procedure|bipolar release|the bipolar release is the surgery that cut the origin and insertion of the sternocleidomastoid muscle that cause the torticollis from its contracture
15911540|NCT03562247|Other|Usual Care of IPF|standard of care given to patients with IPF
15911541|NCT03562247|Other|Telenursing|scheduled phone calls with the patient and care giver
15911542|NCT03562247|Other|Telenursing and Remote Monitoring|scheduled phone calls and home monitoring of physiologic parameters
15911543|NCT03562234|Diagnostic Test|MR|Liver fat (measured as a percentage - hepatic fat fraction) will be measured by Magnetic Resonance imaging
15911544|NCT03562234|Diagnostic Test|LiMAx|Liver function will be measured using the relatively new CE licenced non-invasive LiMAx (Liver Maximum Capacity) test device, manufactured by Humedics GmbH
15911545|NCT03562221|Other|Gluten free diet|Controlled gluten free diet
15911546|NCT03562221|Dietary Supplement|Probiotics|Capsules
15911547|NCT03562221|Dietary Supplement|Placebo|Capsules
15911548|NCT03562208|Biological|Adult Bone Marrow Stem Cells|Autologous Bone Marrow Stem Cells Transplant
15911549|NCT03562195|Drug|Mepolizumab 100 milligrams|Mepolizumab will be given as a lyophilized cake in sterile vials for individual use. The vial will be reconstituted with Sterile Water for Injection, just prior to use.
15911550|NCT03562195|Drug|Placebo|Placebo will be given as 0.9 percent sodium chloride solution.
15911551|NCT03562195|Drug|Salbutamol|Salbutamol MDI will be given as a rescue medication to be used on an as needed basis in this study.
15911552|NCT03562182|Other|blood draw|Blood draw (2.5mL) to assess mRNA LPCAT1 levels
15911553|NCT03562169|Drug|Ixazomib, thalidomide, & dexamethasone (ITD) re-induction|"4 - 6 ITD 28-day cycles as follows:
~Ixazomib 4mg capsule on days 1, 8 and 15
~Thalidomide 100mg capsule on days 1-28
~Dexamethasone 40mg tablets on days 1, 8, 15 and 22"
15911554|NCT03562169|Drug|Conventional autologous stem cell transplant (ASCT-con)|Melphalan 200mg/m2 IV infusion on Day -1, followed by ASCT on Day 0.
15911555|NCT03562169|Drug|Augmented autologous stem cell transplant (ASCT-aug)|Melphalan 100mg/m2 IV infusion on Day -3 and Day -2 plus ixazomib 4mg capsules on Day -4 and Day -1. ASCT will then be given on Day 0.
15911556|NCT03562169|Drug|ITD consolidation and ixazomib maintenance vs. No further therapy|"Participants will be randomised to either 'no further therapy' or 'ITD consolidation and ixazomib maintenance'. Participants randomised to 'no further treatment' will not receive any further treatment but will be followed up at 8 weeks post randomisation 2 and at 3-monthly clinic visits until disease progression.
~Participants randomised to ITD consolidation and ixazomib maintenance will receive:
~Two 28-day cycles of ITD consolidation (same doses as in ITD re-induction). This will be followed by ixazomib maintenance as follows: Ixazomib 4mg capsule on days 1, 8 and 15 of each 28-day cycle until disease progression."
15911557|NCT03562156|Drug|VT-1161|VT-1161 150mg capsule
15911558|NCT03562156|Drug|Placebo|matching placebo capsule
15911559|NCT03562143|Dietary Supplement|Ferrous Sulfate|Patients will take iron supplementation given as 2 tabs of 325 mg ferrous sulfate (equivalent to 130 mg of elemental iron) on alternate day for 6 weeks.
15911560|NCT03562143|Dietary Supplement|Ferrous Sulfate|Patients will take iron supplementation given as 1 tab of 325 mg ferrous sulfate (equivalent to 65 mg of elemental iron) daily for 6 weeks.
15911561|NCT03562130|Drug|Teduglutide|Daily sub cutaneous injection 0,05 mg/kg/day
15911562|NCT03562117|Drug|Gepotidacin|It is an immediate-release tablet (1500 mg (2 x 750 mg), containing gepotidacin (free base) an inactive formulation excipients.
15911563|NCT03562104|Other|videofluoroscopy|Swallowing description in Minimally consciousness Patient
15911564|NCT03562104|Other|Wessex Head Injury Matrix scale|Wessex Head Injury Matrix scale in Minimally consciousness Patient
15911565|NCT03562091|Other|Data collection|The study is an observational evaluation that does not affect physician practices, the physician-patient relationship, or the care of subjects. The prescriptions will be decided prior to inclusion of the subject into the study. The information will be recorded using the data available in the medical file or collected during the visit (as part of the routine subject management).
15911566|NCT03562078|Behavioral|Tai Chi Quan|the first section of Yang style 108 form, including 10-minute warm-up, 40-minute training, and 10-minute cool-down exercise, twice a week
15911567|NCT03562065|Biological|mesenchymal stem cells|"Allogeneic Umbilical Cord derived-MSCs injected by slow intravenous infusion according to the weight of the recipient and patient groups in the study, at doses of:
~1.10^6 CSM / kg
~2.10^6 CSM / kg
~4.10^6 CSM / kg 1 injection during 30min to 1h by Intravenous infusion"
15911569|NCT03562000|Device|Cough Assistance and Systematic Non-Invasive Ventilation|"A standardised bundle of intervention will be tested using the combination of two medical devices previously used in daily clinical practice but without guideline and objective selection criteria, namely:
~A mechanical cough assistance technic using the Cough Assist device (Model E70® by Philips Respironics, Carlsbad, CA, USA) before extubation then after extubation then 3 times a day (with possible additional treatment on demand) during 7 days maximum (with a possible cessation if the patient has strictly no bronchial overload during three consecutive physiotherapy sessions)
~A systematic Non-Invasive ventilation during 24h minimum to indirectly improve the clearance of bronchial overload and to reduce the overall risk of re-intubation related a relative hypoventilation associated to the weak cough."
15911570|NCT03562000|Procedure|control group using the current gold standard of care after extubation, namely the manual drainage by a physiotherapist and the consensual use of Non-invasive ventilation|"After extubation, the physiotherapy will be managed according to standard care and cough assistance will be only manual. The use of a dedicated cough assistance device will be allowed if the bronchial overload clearance is repeatedly insufficient according to the physiotherapist in charge.
~Non-invasive ventilation will not be systematic and only used in case of pre-defined condition, such as: age > 65 years-old, BMI > 30, Chronic cardiac failure, COPD, hypercapnia at the end of the weaning trial, post-operative admissions after abdominal and thoracic surgery."
15911571|NCT03561987|Procedure|Bariatric surgery|There are two components to the procedure. First, a small stomach pouch, approximately one ounce or 30 milliliters in volume, is created by dividing the top of the stomach from the rest of the stomach. Next, the first portion of the small intestine is divided, and the bottom end of the divided small intestine is brought up and connected to the newly created small stomach pouch. The procedure is completed by connecting the top portion of the divided small intestine to the small intestine further down so that the stomach acids and digestive enzymes from the bypassed stomach and first portion of small intestine will eventually mix with the food.
15911572|NCT03561974|Device|Humidification|Patients will benefit of humidification and warming of delivered gaz by non-invasive ventilation thanks humidification system.
15911573|NCT03561961|Radiation|Moderate Hypo-fractionation|66-68Gy in 25#
15911574|NCT03561961|Radiation|Extreme Hypo-fractionation|35-36.25 Gy in 5#
15911575|NCT03561948|Procedure|Experimental group|After performing the surgical intervention, the patient will undergo intraoperative intra-abdominal chemotherapy with mitomycin C. Further, lavage of the abdominal cavity will be repeated, followed by immunological examination.
15911576|NCT03561948|Procedure|Control group|In the control group (40 patients), after laparotomy and revision, peritoneal lavage will also be performed with subsequent immunological examination. Patients of this group will not receive intraperitoneal chemotherapy. After performing the surgical intervention, the patient will be irrigation of the abdominal cavity with physiological saline. Further, lavage of the abdominal cavity will be repeated, followed by immunological examination.
15911577|NCT03561935|Drug|Propafenone|prescribing propafenone for the management of premature ventricular complex
15911578|NCT03561935|Drug|Indenol|prescribing indenol for the management of premature ventricular complex
15911579|NCT03561922|Device|RETINA IMPLANT Alpha AMS|Implantation of the subretinal RETINA IMPLANT Alpha AMS
15911580|NCT03561909|Other|Platelet transfusion|Transfusion of a platelet dose from 20 × 10ˆ9 to 100 × 10ˆ9.
15911581|NCT03561896|Radiation|IGRT|Image-Guided Radiation Therapy
15911582|NCT03561896|Radiation|SRS|stereotactic radiation therapy
15911583|NCT03561883|Drug|IW-3718|oral tablet
15911584|NCT03561883|Drug|placebo|oral tablet
15911585|NCT03561883|Drug|Standard-dose PPIs QD|background therapy
15911586|NCT03561870|Drug|Olaparib 150 MG|Olaparaib: 600 mg/day: 300 mg BID (2 x 150 mg tablets taken orally) each 28 days cycle, until disease progression or unacceptable toxicity
15911587|NCT03561857|Device|Confocal Laser Endomicroscopy|"The study is divided in 2 parts.
~Ex vivo study
~Prostate specimens will be stained using Fluorescein
~Images/sequences of normal and abnormal prostatic tissues, and peri-prostatic tissues will be acquired.
~In vivo study
~Intravenous injection of contrast agent
~pCLE imaging every 5mm of the NVB dissection zone."
15911588|NCT03561844|Other|aromatherapy|Each of participants in the aromatherapy (inhalation) group will receive inhalation aromatherapy and those in the aromatherapy (massage) group will receive aromatherapeutic massage. As to the waiting control group, participants will be given either one of these two interventions after the implementation phase is completed.
15911589|NCT03561831|Drug|Propofol|propofol based anesthesia
15911590|NCT03561831|Drug|Sevoflurane|sevoflurane based anesthesia
15911591|NCT03561818|Other|Hospital-based pulmonary rehabilitation|The patients who undergo two days pulmonary rehabilitation under supervision in our clinic and three days a week at home during two months will taken as hospital group. The exercises include breathing exercises, treadmill (15sc), cycle training (15sc), arm ergometer training (15sc), peripheral muscle training and stretching exercises with free weights.
15911592|NCT03561818|Other|Home-based pulmonary rehabilitation|The patients who follow a home-based pulmonary rehabilitation program for two months comprising breathing exercises, training in chest hygiene techniques, peripheral muscle strengthening training and self-walking for 5 days in a week for two months. An exercise follow-up form will give to the patients to record their daily exercises. A similar form will fill by physiotherapist once a week during phone call.
15911593|NCT03561805|Device|ECG monitoring|Prolonged continuous ECG monitoring using the CardioSTAT® device within the 3 months prior to the TAVI procedure
15911594|NCT03561792|Other|Diaphragm ultrasound|In the semi-sitting position ultrasonography for diaphragmatic displacement was performed by the same intensivist. Diaphragmatic movement was evaluated by using 2 to 5 MHz US probe (Sonosite M-Turbo machine). The right hemidiaphragm was examined by two-dimensional (2D) and M-mode to record diaphragm displacement.in M-mode, the diaphragmatic displacement (cm) was measured and then DRSBI was calculated by respiratory rate (RR)/ diaphragmatic displacement (DD) (in mm)
15911595|NCT03561779|Drug|YYD302 2ml|YYD302 2ml
15911596|NCT03561779|Drug|Active comparator: Synovian Inj.|Active comparator: Synovian Inj.
15911597|NCT03561753|Drug|Group A (the standard 2HRZE/4HR regimen）|The standard six-month regimen is eight weeks of daily treatment with isoniazid, rifampin, ethambutol, and pyrazinamide followed by sixteen weeks of isoniazid and rifampin. The six-month regimen is the standard regimen for the treatment of drug-susceptible tuberculosis recommended by WHO.
15911598|NCT03561753|Drug|Group B (New short course PRS regimen, 4EZ(high dose)PtoCfz)|The PRS regimen I（new short course PRS regimen） is 4 months of daily Cfz, Emb, Pto, and high dose pyrazinamide, dosed by weight.Comparison of Standard Regimen：The standard six-month regimen is eight weeks of daily treatment with isoniazid, rifampin, ethambutol, and pyrazinamide followed by sixteen weeks of isoniazid and rifampin.
15911599|NCT03561740|Drug|capecitabine|additional metronomic chemotherapy of capecitabine
15911600|NCT03561727|Procedure|Mass closure technique|Abdominal cavity will be closed by a single layer of 2 continuous sutures beginning on the opposite ends of the wound towards the median line and involving peritoneum, transversalis fascia, posterior and anterior layer of rectus abdominis muscle fascia and, in case of incisions beyond the lateral border of rectus abdominis muscle, also the oblique abdominal muscles fascia.
15911601|NCT03561727|Procedure|Layered closure technique|he first layer will include peritoneum, transversalis fascia and posterior layer of the rectus abdominis muscle fascia closed with 2 continuous sutures beginning at both ends of the wound. In case of incisions exceeding the lateral border of rectus abdominis muscle, the second layer of the continuous suture will start at the lateral border of rectus abdominis muscle, process laterally to the lateral end of the wound involving internal oblique abdominal muscle fascia. Subsequently, the suture will be led out on the anterior surface of the external oblique abdominal muscle, put through by the created loop in the medial direction and processed medially to close the external oblique abdominal muscle fascia and anterior layer of the rectus abdominis muscle fascia.
15911602|NCT03561714|Behavioral|Cardometabolic Team Intervention|The CMC-TI team included a registered nurse/certified diabetes educator (RN/CDE) Care Manager, medical assistant (MA) Health Coach, and RN Depression Care Manager. Decision support tools guided therapy for glucose, BP, low-density lipoprotein cholesterol (LDL-c), and depression. At the intervention clinic, the 12-month CMC-TI was delivered to all qualifying patients; surveys were administered to evaluate relevant patient-reported outcomes over 12 months.
15911603|NCT03561701|Drug|VT-1161|VT-1161 150mg capsule
15911604|NCT03561701|Drug|Placebo|matching placebo capsule
15911605|NCT03561688|Device|Foot orthotics|Insoles for shoes
15911606|NCT03561688|Device|Standard insole|Sham foot orthotic
15911607|NCT03561675|Drug|ACETAZOLAMIDE oral capsule|Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m
15911608|NCT03561675|Drug|Placebo oral capsule|Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m
15911609|NCT03561662|Dietary Supplement|Alpro soya drinks|12 weeks
15911610|NCT03561649|Drug|Adalimumab|This trial will be conducted by rheumatologists who can follow patients with SpA and conduct this trial in good conditions and in accordance with regulatory and legal recommendations.
15911611|NCT03561623|Other|magnetic resonance (MR) Imaging|MRI of spinal cord and brain
15911612|NCT03561623|Other|quantitative muscle force assessment|quantitative assessment of muscle force
15911613|NCT03561610|Dietary Supplement|sip feed|normal oral Nutrition + sip feed (Fresubin2.0®; covers individual energy and nutrient demands; high in protein)
15911614|NCT03561610|Dietary Supplement|gumdrops|normal oral Nutrition + gumdrops (Nutrimed®; covers individual energy and nutrient demands; high in protein)
15911615|NCT03561597|Behavioral|Mobile health intervention|The Kurbo program is a multifunctional mobile application that aid adolescents and their families to learn healthy eating habits and weight management through the use of a mobile application with dietary self-monitoring and weekly interactive coaching sessions. Using the Kurbo app, adolescents track their food and exercise, as well as learn about healthy behaviours through games and videos. The Kurbo coaches check in with adolescents for 15 minutes once a week via video, phone or text over a 12 weeks period.
15911616|NCT03561584|Drug|Sulfasalazine|Patients will be initiated on a low dose of sulfasalazine (500 mg) twice daily (bid). Dosage will be increased throughout the study.
15911617|NCT03561584|Drug|Placebo|Patients will be initiated on 1 placebo tablet twice daily (bid). Dosage will be increased throughout the study.
15911618|NCT03561571|Other|butter based breakfast|ingestion of proteins : 5 g, lipids 20 g, glucides 57 g
15911619|NCT03561571|Other|Chocolate spread based breakfast|ingestion of proteins 7 g, lipids 20 g, glucides 56 g
15911620|NCT03561558|Drug|Ibuprofen D|Ibuprofen D, oral suspension, 200 mg / 5ml, manufactured by LLC Pharmtechnology, Belarus
15911621|NCT03561558|Drug|Nurofen® for Children|Nurofen® for Children, Oral Suspension, 100 mg / 5 ml, marketed by Reckitt Benckiser Healthcare International Ltd, UK
15911622|NCT03561545|Other|weightlessness (parabolic flight)|weightlessness (parabolic flight)
15911623|NCT03561532|Other|Fecal microbiota transplantation (FMT)|FMT administered into the cecum of the patient in colonoscopy.
15911624|NCT03561532|Other|Placebo|Autologous FMT (fecal suspension made of patients own feces) administered into the cecum of the patient in colonoscopy.
15911625|NCT03561519|Other|Fecal Microbiota Transplantation (FMT)|Fecal suspension administered in colonoscopy into the cecum of the patient.
15911626|NCT03561519|Other|Placebo|As a placebo a fecal suspension made of patients own feces is administered into the cecum of the patient in colonoscopy.
15911627|NCT03561506|Drug|Ferric carboxymaltose|Ferinject®to be administered as IV drip infusion or undiluted bolus injection to consented patients with preoperative anemia before total knee arthroplasty.
15911628|NCT03561506|Drug|0.9% Normal Saline|Placebo(0.9% Normal Saline) to be administered as IV drip infusion or bolus injection to consented patients with preoperative anemia before total knee arthroplasty.
15911629|NCT03561493|Other|zumba exercise|Participants will engage in 16 classes of 60-minute Zumba® fitness for two consecutive menstrual cycles (an 8-week period, twice weekly). Each class was one hour in length and a recovery period of at least 48 h was taken between classes. Each session will be initiated with low-intensity movements for the ﬁrst 5 min, followed by an increasing intensity throughout the workout. At the end of the training session, the intensity will be gradually reduced. The Zumba sessions will be supervised by three certiﬁed Zumba instructors, each responsible for regular sessions per week.
15911630|NCT03561480|Drug|Ferric carboxymaltose|Ferinject®to be administered as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg single administration) for body weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight <50Kg .
15940433|NCT03338023|Drug|LY2963016|Administered SC
15911631|NCT03561480|Drug|0.9% Normal Saline|Placebo will be in the form of normal saline administered over same time period as equivalent Ferinject® administration. IV drip infusion or undiluted bolus injection with a minimum administration time of 15 minutes (200mL as infusion or 20mL as bolus injection) for body weight ≥50 Kg or 6 minutes (100mL normal as infusion or 10mL as bolus injection) for body weight <50 Kg.
15911632|NCT03561467|Other|Observational|Evaluation of dysfunctions in the continuous city-hospital journey of a patients cohort treated by oral chemotherapy
15911633|NCT03561454|Device|IORT|Intra-Operative Radiation Therapy
15911634|NCT03561441|Drug|Tailored aggressive hydration|"Hydration with lactated Ringer's solution with rate of 3.0 milliliter(mL)/kg/hr during and after ERCP and bolus injection of 20mL/kg for 1 hour after ERCP.
~At 4 hours after ERCP (patients with ERPD stent insertion ; 6 hours), abdominal pain and serum amylase are checked. If pain (≥ Numeric rating scale (NRS) scale 3) is absent and amylase is below 1.5 times the upper normal limit (UNL), patient starts feeding and stops hydration. If patient has any of these signs, fasting and hydration continues.
~At 8 hours, if pain (<NRS scale 3) is absent, patient starts feeding and stops hydration. If patient has pain (≥ NRS scale 3) and previously checked amylase or re-checked serum amylase is above 3 times the UNL, patient is regarded as post-ERCP pancreatitis and receives 3mL/kg hydration. Patient with pain (≥ NRS scale 3) and previously checked serum amylase above 1.5 times but below 3 times the UNL, serum amylase is re-checked."
15911635|NCT03561441|Drug|Tailored standard hydration|"Hydration with lactated Ringer's solution with rate of 1.5milliliter(mL)/kg/hr during and after ERCP.
~At 4 hours after ERCP (patients with ERPD stent insertion ; 6 hours), abdominal pain and serum amylase are checked. If pain (≥ Numeric rating scale (NRS) scale 3) is absent and amylase is below 1.5 times the UNL(upper normal limit), patient starts feeding and stops hydration. If patient has any of these signs, fasting and hydration continues.
~At 8 hours, if pain (<NRS scale 3) is absent, patient starts feeding and stops hydration. If patient has pain (≥ NRS scale 3) and previously checked amylase or re-checked serum amylase is above 3 times the UNL, patient is regarded as post-ERCP pancreatitis and receives 3mL/kg hydration. Patient with pain (≥ NRS scale 3) and previously checked serum amylase above 1.5 times but below 3 times the UNL, serum amylase is re-checked."
15911636|NCT03561415|Other|Universal Posaconazole Prophylaxis|All patients assigned to this arm will start posaconazole between Day 4 and Day 14 post lung or heart-lung transplant for a minimum of 3 months.
15911637|NCT03561415|Other|Pre-emptive Posaconazole Therapy|Posaconazole will be started if a fungal pathogen is identified or there is serological evidence of a fungal pathogen in the absence of any evidence of invasive fungal disease for 3 months.
15911638|NCT03561402|Drug|Teriflunomide|Each patient will receive 1 tablet (14 mg) on a daily basis.
15911639|NCT03561376|Drug|Topical zinc oxide vs. petrolatum post-surgical scars|"Following linear closure on non-scalp skin with scar length > 4.5 cm, incision site will be split and petrolatum applied to one half and zinc oxide ointment to the other half daily for one month following surgery."
15911640|NCT03561363|Behavioral|High-fat diet|The aim of the intervention is to evaluate whether insulin sensitivity and selected Health parameters is affected, when the intake of saturated fatty acids or polyunsaturated fatty acids are highly increased, even when subjects are in energy balance.
15911641|NCT03561337|Dietary Supplement|PROTEIN-CARBOHYDRATE|PRO before and PRO-CHO after training
15911642|NCT03561337|Dietary Supplement|CARBOHDYRATE|CHO before and after training
15911643|NCT03561324|Device|Imaging Beta Probe (IBP)|Using IBP for imaging of PET positive lymph nodes
15911644|NCT03561311|Device|remote ischemic conditioning|Remote ischemic conditioning is performed by using an electric autocontrol device with cuffs that inflated to a pressure of 200 mm Hg during the ischemic period (Patent No. CN200820123637.X, China)
15911645|NCT03561311|Device|sham remote ischemic conditioning|Sham remote ischemic conditioning is performed by using an electric autocontrol device with cuffs that inflated to a pressure of 60 mm Hg
15911646|NCT03561298|Drug|BGB-3111 and Drug Cocktail|BGB-3111 and Drug Cocktail (midazolam, warfarin, omeprazole, digoxin and rosuvastatin)
15911647|NCT03561285|Diagnostic Test|antiphospholipid Abs|Laboratory test
15911648|NCT03561272|Other|Smart Phone Application|Oral medication adherence phone application.
15911649|NCT03561272|Other|POD|Pill dispensing system that dispenses the medication, controls dispensed dosage, and confirms dispensing to patient through wireless communication back to the control center.
15911650|NCT03561259|Drug|131I-MIBG|Subjects will receive 18 mCi/kg of 131I-MIBG administered over 1.5 to 2 hours on Day 1 either a central line or a peripheral intravenous catheter. The maximum absolute dose of 131I-MIBG is determined by institution therapeutic limits and will not exceed 1,000 mCi. Subjects with an overall response of stable disease or better as assessed by the Investigator, and who meet certain protocol predefined criteria, may receive a second 18 mCi/kg 131I-MIBG treatment no sooner than 6 weeks following the first treatment.
15911651|NCT03561259|Drug|131-MIBG + Vorinostat|Subjects will receive vorinostat 180 mg/m2/dose (maximum dose 400 mg) once daily by mouth, NG, or G-tube on days -1 to +12 (14 total doses) for 14 days continuously. The 131I-MIBG treatment will be administered on day 1 via either a central line or a peripheral intravenous catheter over 1.5 to 2 hours. On day 1 of therapy, vorinostat should be taken 1 hour prior to the start of the 131I-MIBG infusion. Subjects with an overall response of stable disease or better, as assessed by the Investigator and who meet certain predefined criteria, may receive a second course of 18 mCi/kg 131I-MIBG combined with vorinostat (180 mg/m2) no sooner than 6 weeks following the first therapeutic 131I-MIBG treatment.
15911652|NCT03561246|Other|Incline treadmill walking|Those with a Pp 0.47 will undergo INCLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs.
15911653|NCT03561246|Other|Decline treadmill walking|Those with a Pp 0.53 will undergo DECLINE training during which individuals will walk for 15 minutes at a 10-degree treadmill tilt, stopping each five minutes for monitoring of vital signs.
15911654|NCT03561233|Drug|Omeprazole 20mg|omeprazole 20 mg twice daily 30 minutes before meal for 4 weeks
15911655|NCT03561220|Radiation|Standard of Care IMRT (Photon)|As this trial is pragmatic, all treatment will be standard of care.
15911656|NCT03561220|Radiation|Standard of Care Proton Therapy|As this trial is pragmatic, all treatment will be standard of care.
15911657|NCT03561220|Radiation|Proton Arm 1: Standard Proton Therapy|78.0 Gy (RBE) in 39 fractions
15911658|NCT03561220|Radiation|Proton Arm 2: Hypofractionated Proton Therapy|60.0 Gy (RBE) in 20 fractions
15911659|NCT03561207|Diagnostic Test|EV3D Assay|The EV3D assay uses freshly obtained tumor specimen to predict tissue drug response.
15911660|NCT03561194|Dietary Supplement|Omegaven|After the diagnosis of PNALD is made, patients who are followed by the Neonatal Intensive Care Unit, NICU, will contact Dr. Honrubia and Dr. Swarup. Cases may also include referrals of patients with PNALD from other healthcare facilities or self-referrals. If the patient's parents or guardians agree to participate in the study, informed consent will be obtained. The history of present illness and past medical history will be reviewed with the guardian and pertinent demographic and medical information will be recorded on data collection forms. This form will be used to record all laboratory results, nutritional history, and descriptions of any liver biopsies performed.
15911661|NCT03561181|Biological|S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine|Group 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine.
15911662|NCT03561181|Biological|S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine|Group 2:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 5 µg S.Flexneriza-S.Sonnei Bivalent Conjugate Vaccine.
15911663|NCT03561168|Diagnostic Test|Change in plan of care based on MRI results|"Study subjects have received the intervention if the results of their MRI either 1. provide an etiology for said MRI's indication or 2. the patient received a change in plan of care based on MRI results."
15911664|NCT03561155|Device|Robot assisted treatment (Amadeo®)|"The protocol will consist of exercises as follows:
~passive modality , passive/plus modality , assisted therapy and Balloon."
15911665|NCT03561155|Other|Conventional treatment|"The protocol will consist of exercises as follow:
~upper limb mobilization, facilitation of movements and active tasks. The exercises will be focused on improving muscle strength, finger extension and flexion and motor control"
15911666|NCT03561142|Radiation|Radiotherapy|Radiotherapy: 28 x 1.8 Gy (total: 50.4 Gy), 5 fractions per week on day 1- 38
15911667|NCT03561142|Drug|Chemotherapy|chemoradiotherapy is started according to the following schedule: 5-FU: 250 mg/sqm per day, iv, on day 1-14, day 22-35; Oxaliplatin: 50 mg/sqm, day 1, 8, 22, and 29. After a break of two and a half weeks, patients receive three chemotherapy cycles, starting on day 57, 71 and 85, consisting of: Folinic acid: 400 mg/sqm, 2h-iv; Oxaliplatin: 100 mg/sqm, 2h-iv; 5-FU: 2400 mg/sqm, 46h-iv
15911668|NCT03561142|Other|Deep regional hyperthermia|"Deep regional hyperthermia to the pelvis, total time 90 min, target temperature 41-42°C. Twice weekly, up to a total of 10 sessions within d1 and d38.
~Deep regional hyperthermia is offered at the centers in Tübingen and Erlangen."
15911669|NCT03561129|Other|Embryo transfer|all the fresh embryo transfers, performed between January 1997 and December 2016 at Humanitas Fertility Center after IVF-ICSI cycles, divided per operator
15911670|NCT03561116|Dietary Supplement|XAN|Daily intake of a sachet containing 12 mg of XAN
15911671|NCT03561116|Dietary Supplement|Placebo|Daily intake of a sachet containing excipient
15911672|NCT03561103|Behavioral|Client-Centered Representative Payee|CCRP is a structural intervention wherein Social Security authorizes a representative payee to serve as financial manager for people who need help managing their money. By helping clients to consistently pay their bills including rents and utilities, CCRP may redirect the expenditure of participants' resources toward improved health behaviors. Shifting the focus of material and biopsychosocial resources may change the context in which health behaviors are produced, contributing to higher rates of adherence and viral suppression. CCRP modifies the implementation of a current policy of the Social Security Administration (SSA) to create an intervention that is highly replicable.
15911673|NCT03561090|Drug|IW-3718|oral tablet
15911674|NCT03561090|Drug|placebo|oral tablet
15911675|NCT03561090|Drug|Standard-dose PPIs QD|background therapy
15911676|NCT03561077|Other|Mindfulness-based interventions (MBI's)|Mindfulness Based Intervention with eight sessions (one session per week) of two hours dedicated to adolescents will be provided. The intervention will focus on skill building and will incorporate mindfulness meditation, exercises and activities specially adapted to teenagers with chronic pain. Topics will include mind body connection, the effect of stress on pain, living in the present moment, focused awareness, responding versus reacting to pain and/ or difficult situations, non judgement, gratitude, kindness and compassion towards self and others.
15911677|NCT03561064|Behavioral|CBT-I|Eligible participants will receive CBT-I by a licensed clinical psychologist.
15911678|NCT03561038|Device|Franseen Needle|Comparing 2 needles designed for tissue acquisition
15911679|NCT03561038|Device|Fork-tip Needle|Comparing 2 needles designed for tissue acquisition
15911680|NCT03561025|Diagnostic Test|18F-FDG-PET/MRI|Contrast-enhanced MRI scanning after injection of 18F-FDG
15911681|NCT03561025|Diagnostic Test|18F-GE180-PET/MRI|Contrast-enhanced MRI scanning after injection of 18F-GE180
15911682|NCT03561012|Behavioral|Team-Based Goals and Incentives|The intervention included 3 main components. 1) The intervention fostered a sense of team collective responsibility and solidarity (TEAM) by emphasizing the value of teamwork and front-line community health workers (FLWs) reciting a pledge at meetings to serve beneficiaries. 2) To establish goals and coverage targets related to maternal and child health outcomes (GOALs), 7 targets were identified related to delivery preparations, newborn care, exclusive breastfeeding, and family planning. 3) Small non-cash incentives were awarded to FLWs each quarter if their team met greater than 70% of the collective subcenter goals; incentives were most common cookware products (e.g., dish, cooking vessel, steamer). Non-cash incentives also included a certificate of recognition for teams that met their targets in all quarters (INCENTIVES). In the areas of the intervention and control arms, the Ananya program was also underway (see Brief Summary of the project).
15911683|NCT03561012|Other|Control Condition|Standard of care
15911684|NCT03560986|Drug|Neridronic acid 100 mg|100 mg neridronic acid supplied in glass vials in 8 mL of excipients.
15911685|NCT03560986|Drug|Placebo|Glass vials with matching placebo.
15911686|NCT03560973|Drug|Gemcitabine|ramucirumab/ placebo was added to gemcitabine
15911687|NCT03560973|Drug|Ramucirumab|ramucirumab/ placebo was added to gemcitabine
15911719|NCT03560609|Device|Ophthalmodynamometer|The ODM (Baillart ophthlmodynamometer) is a disc attached to a piston that induces a controlled force on a fixed area. The device will be used to apply a pressure within the range of 10 mmHg - 50 mmHg 4 times to each eye. Each increase of pressure will last approximately 30 seconds. The device is FDA approved and will be used as routinely used in clinical practice
15940434|NCT03338023|Drug|Lantus®|Administered SC
15911688|NCT03560960|Drug|Pramlintide challenge test|Enrolled subjects will have a pre-trial blood draw (3 ml) and will be placed with an IV needle for future blood draws. Pramlintide will be subcutaneously injected in the abdominal area. For each arm the participants will be randomized so that half will be given a dose of 0.8 mcg/kg and the other half of the arm a dose of 1.6 mcg/kg. Blood will be drawn before and at 5, 30, 60, and 180 min after injection. Vital signs and blood glucose will also be checked at these time points. Thirty minutes after the injection, subjects will be offered a standard meal. Subjects will have a final check of vital signs and blood glucose approximately 15 min before discharge.
15911689|NCT03560947|Other|Manual Therapy and Exercise (Physiotherapy Intervention)|Experimental group: Manual Therapy and Exercise Participants in this group will receive a 6-weeks program of mobilization and progressive exercise programme for the neck flexors, 2 times a week.
15911690|NCT03560947|Other|Usual Care (Physiotherapy Intervention)|Active Comparator: Usual Care Participants in this group will receive usual care in physiotherapy during the 6-weeks period.
15911691|NCT03560934|Drug|Dronabinol|Single dose oral administration of 10-60mg dronabinol prior to night 2 or 3 sleep in the clinical laboratory.
15911692|NCT03560921|Diagnostic Test|urinary NGAL|measurement urinary NGAL using the ARCHITECT technique
15911693|NCT03560908|Drug|Dasatinib|Dasatinib 70mg twice a day will be administered orally for 2 weeks along with re-induction chemotherapy from day 1 of chemotherapy. Recommended re-induction regimens include (1)FLAG: Fludarabine 30mg/m2/d,d1-5;cytarabine 1g-2g/m2/d,d1-5;±G-CSF;(2)IA/DA:idarubicin 8-12mg/m2/d,d1-3 or daunorubicin 45-60mg/m2/d，d1-3;cytarabine 100-200mg/m2/d，d1-7;(3)CAG:Aclarubicin 20mg/d,d1-4；cytarabine 15mg/m2/Q12h,d1-14; ±G-CSF.The chemotherapy regimen is not limited to recommended regimens. Patients will be recommended to receive allogeneic hematopoietic stem cell transplantation (HSCT) once complete remission is achieved. Otherwise, they will continue the consolidation chemotherapy.
15911694|NCT03560895|Device|MICROCUFF * endotracheal tube|Patients will be anesthetized using low-volume cuffed Kimberly-Clark * MICROCUFF * endotracheal tube (Microcuff, Halyard Health Inc., Atlanta, GA, USA), with its outer diameter determined by ultrasonography.
15911695|NCT03560895|Device|cuffed endotracheal tube|Patients will be anesthetized using high-volume low-pressure cuffed endotracheal tube
15911696|NCT03560895|Device|Uncuffed endotracheal tube|Patients will be anesthetized using uncuffed endotracheal tube
15911697|NCT03560882|Drug|Atorvastatin|Atorvastatin tablet, 80mg
15911698|NCT03560869|Other|Normal hydration|see description in 'arms'
15911699|NCT03560869|Other|Dehydration|see description in 'arms'
15911700|NCT03560856|Drug|Fulvestrant + palbociclib|Patients will be treated by Fulvestrant 500mg (day 1 and day 15) and then on Day 1 of each subsequent cycle and every 28 days with palbociclib 125 mg daily for 3 weeks on/1 week off (3/1 schedule).
15911701|NCT03560843|Behavioral|MBSR|Mindfulness Based Stress Reduction
15911702|NCT03560830|Other|2 submaximal exercise stress tests|
15911703|NCT03560804|Drug|Olmesartan|Administration of olmesartan at starting dose and titrating in order to reach the target blood pressure.
15911704|NCT03560804|Drug|Chlorthalidone|Administration of chlorthalidone at starting dose and titrating in order to reach the target blood pressure.
15911705|NCT03560765|Device|MED|Training in the use of mainstream electronic devices with accessibility options
15911706|NCT03560765|Other|Buddy|A buddy who will meet with the participant regularly for social interaction, and assistance with use of any MED purchased
15911707|NCT03560752|Biological|Multi-peptide CMV-Modified Vaccinia Ankara Vaccine|Given via injection
15911708|NCT03560739|Combination Product|ofatumumab with PRF|ofatumumab 20 mg subcutanious injection administered with pre-filled syringe (PRF)
15911709|NCT03560739|Combination Product|ofatumumab with AI|ofatumumab 20 mg subcutaneous injection administered with autoinjector (AI)
15911710|NCT03560726|Behavioral|Cognitive Behavioral Stress Management|Cognitive behavioral stress management is a well-established, practical intervention that combines elements of cognitive behavioral therapy with techniques designed to improve coping skills, social support, communication, and relaxation/mindfulness.
15911711|NCT03560713|Device|Functional Electrical Stimulation (FES)|Participants will perform 12 weeks of FES (Neurodyn High Volt, IBRAMED, São Paulo/SP, Brasil), three times a week, frequency 25Hz, pulse rate of 200μs, ON:OFF 5:5, individual maximum tolerated intensity; minimum at strong but comfortable visible muscle contraction (without causing undue pain or discomfort to the participant). during 30 minutes nd receive aerobic exercise training and resistance exercises for upper limbs and lower limbs.
15911712|NCT03560713|Other|Functional Electrical Stimulation (FES) sham|Participants will perform 12 weeks of Functional Electrical Stimulation (FES) sham (Neurodyn High Volt, IBRAMED, São Paulo/SP, Brasil), three times a week, frequency 5Hz, pulse rate of 200μs, ON:OFF 5:5, without muscle contraction during 30 minutes nd receive aerobic exercise training and resistance exercises for upper limbs and lower limbs.
15911713|NCT03560700|Dietary Supplement|lactobacillus probiotic strain|Approved Dietary supplement
15911714|NCT03560700|Other|placebo|placebo comparator
15911715|NCT03560687|Drug|Sucrosomial Iron|CardioSideral 2 caps per day
15911716|NCT03560648|Device|High definition surface electromyography combined with accelerometer|HD-sEMG and accelerometer data will be collected by Mobita 32® (TMSi) device.
15911717|NCT03560635|Behavioral|Weight Loss Maintenance (Control vs. Reverse Diet)|Participants in both groups will receive a 12-week comprehensive, individually delivered behavioral weight loss maintenance intervention, adapted from the Diabetes Prevention Program (DPP) Post-CORE program. This program focuses on utilization of tools and strategies to maintain a healthy lifestyle and prevent weight regain, and is therefore most appropriate for the weight-reduced population we will enroll. While the DPP Post-CORE program includes 15 sessions delivered over 15-months, we will deliver sessions #1-12 and 15 over a 12-week period. Content for sessions 13 and 14 from the DPP Post-CORE curriculum focus specifically on Type 2 Diabetes Mellitus and Heart Disease. The informational handouts will be provided to participants, but not specifically covered in weekly meetings. Groups will differ only in specific caloric prescriptions (described in the Arms section).
15911718|NCT03560622|Device|multi-modality neuroimaging|multi-modality neuroimaging consists of structural imaging, diffusion tensor imaging (DTI), task-based functional MRI (t-fMRI), and resting state functional MRI (rs-fMRI).
15911824|NCT03559868|Drug|Digoxin|Different doses of oral digoxin to test if digoxin has an effect on the immune response of peripheral blood levels (PBLs).
15911720|NCT03560609|Device|Goldmann applanation tonometer|The Goldmann applanation tonometer (Haag-Streit, Basel, Switzerland) measures the IOP after the eye is numbed with a drop of anesthetic (proparacaine), which is approved by the FDA. Proparacaine is part of routine patient care using a tonometer regardless of participation in this study. The instrument's tip lightly touches the surface of the cornea and the IOP is measured. The device is FDA approved is routinely used in clinical practice.
15911721|NCT03560609|Device|Pentacam|This device maps the cornea and provides pachymetry, topography and corneal aberration maps. The device is FDA approved and routinely used in clinical practice.
15911722|NCT03560609|Device|ORA|ORA is an air puff tonometer that applies controlled force to flattens the cornea and provides the corneal hysteresis and corneal resistance factor. The device is FDA approved and routinely used in clinical practice.
15911723|NCT03560609|Device|Optical Coherence Tomography (OCT)|OCT is a non-contact,real-time, high resolution, and reproducible imaging modality that provides in-vivo optical cross-sectional scanning of the retina, the ONH and of the anterior segment structures including the cornea. Clinical staff will perform subject testing, not research coordinators. Information about these non-FDA approved OCTs and the multi-modal adaptive optics system can be found in appendices A, B, C, and D. With all devices, the participant sits in a slit lamp like frame. A low power laser light is projected toward the back of their eyes while the subject fixates on a target. None of the systems produce harmful radioactive radiation.
15911724|NCT03560596|Behavioral|Adherence Intervention|9 sessions with bilingual health coaches who will utilize a culturally tailored adherence checklist to identify patients specific medication adherence barriers.
15911725|NCT03560596|Behavioral|Usual Care|standard hypertension treatment recommendations as determined by PCP
15911726|NCT03560583|Drug|Metoclopramide|Metoclopramide 10 mg BID
15911727|NCT03560583|Drug|Placebo Oral Tablet|Placebo 10 mg BID
15911728|NCT03560570|Biological|Coagulation assay|Conventional coagulation assays: prothrombin time (PT), activated partial thromboplastin time (aPTT), fibrinogen, factor II, FV, FVII, FX, FVIII, FIX, FXI, FXII, d-dimers, antithrombin, protein C, protein S Thrombin generation assay: in presence or not of soluble thrombomodulin
15911729|NCT03560570|Other|Clinical data collection|At inclusion, we recorded clinical data about the disease (type and form of congenital disorder of glycosylation, and antecedent of microvascular event: thrombosis, stroke-like or hemorrhages)
15911730|NCT03560544|Behavioral|Breaking up sitting|"A three-part behaviour change intervention, including:
~Supportive organisational culture and knowledge of consequence of prolonged sitting
~Environmental Modification
~Behavioural Changes"
15911731|NCT03560531|Drug|ZN-c5|ZN-c5 is a study drug
15911732|NCT03560531|Drug|Palbociclib|Palbociclib (IBRANCE®) is an approved drug
15911733|NCT03560518|Drug|Rapastinel|Rapastinel (prefilled syringe, weekly intravenous IV administration)
15911734|NCT03560518|Drug|Placebo|Placebo (prefilled syringe, weekly IV administration)
15911735|NCT03560505|Diagnostic Test|Ultrasound protocol|High-resolution ultrasound protocol at pre-defined sites bilaterally. Pre-defined sites: Sciatic nerve (proximal and distal), tibial nerve (proximal and distal), common fibular nerve (proximal and distal), superficial fibular nerve (proximal and distal) and sural nerve (proximal and distal).
15911736|NCT03560492|Other|Exercises|5 sessions of exercises of 20 minutes each. Participants have to do a set of cervical, dorsal and abdominal stretching and strengthening exercises. Participants receive instructions to continue at home on a daily basis for 3 months and record compliance in a logbook.
15911737|NCT03560492|Device|Posture garment|Participants are provided with the appropriate size of a posture garment which includes thoracic and abdominal tensional bands. They are instructed to wear it 2 to 4 h per day for a 3 month period and record compliance in a logbook daily.
15911738|NCT03560479|Drug|alpha1H, 7.4 mg/mL|Intravesical instillations on 6 occasions during 22 days (Days 1, 3, 5, 8, 15 and 22)
15911739|NCT03560479|Other|placebo|Intravesical instillations on 6 occasions during 22 days (Days 1, 3, 5, 8, 15 and 22)
15911740|NCT03560479|Drug|alpha1H, 37 mg/mL|Intravesical instillations on 6 occasions during 22 days (Days 1, 3, 5, 8, 15 and 22)
15911741|NCT03560479|Drug|alpha1H, 74 mg/mL|Intravesical instillations on 6 occasions during 22 days (Days 1, 3, 5, 8, 15 and 22)
15911745|NCT03560453|Behavioral|Project SEARCH Plus ASD Supports|Project SEARCH is an intensive 9-month job training program where youth with developmental disabilities in their last year of high school are embedded in a large community business such as a hospital, government complex, or banking center (Daston et al., 2012). Students with developmental disabilities who participate in this model rotate through three 10-12 week internships within the business where they log approximately 720 hours of internship time learning marketable skills while receiving supported employment. They also get 180 hours of classroom time at the business for a total of approximately 900 hours embedded in the business setting. In addition to these important training components, Project SEARCH requires collaboration between multiple community partners to support students in attaining employment upon completion of the program. Collaborations include students with developmental disabilities and their family, a LEA, a local CRP, the state VR, and a host business.
15911746|NCT03560440|Other|Plasma exposure vancomycin|Investigation of plasma exposure of vancomycin.
15911747|NCT03560427|Drug|Duloxetine 60mg|"Patients will receive duloxetine, 60 mg tablet 2 hour before operation and will be anesthetized by combined spinal-general anesthesia that includes: spinal anesthesia with morphine 0.3 mg delivered in L4-5 inter spinous space.
~General anethseia: Induction of anesthesia was done by intravenous fentanyl, 2 µg / kg and propofol 1 - 2 mg / kg. Endotracheal intubation was achieved by cis-atracurium, 0.15 mg / kg. Maintenance of anesthesia was done by isoflurane and cis-atracurium, 0.03 mg / kg on demand. Additional intraoperative analgesia was consisted of administration of intravenous boluses of fentanyl, 50 µg according to the attending anesthesiologist's decision. At the end of surgery, muscle relaxation was reversed using neostigmine 0.05 mg / kg and atropine 0.01 mg / kg."
15911825|NCT03559868|Other|Placebo|Oral placebo
15940435|NCT03338023|Drug|Insulin Lispro|Administered SC
15911748|NCT03560427|Drug|placebo|"Patients will receive placebo tablet 2 hour before operation and will be anesthetized by combined spinal-general anesthesia that includes: spinal anesthesia with morphine 0.3 mg delivered in L4-5 inter spinous space.
~General anethseia: Induction of anesthesia was done by intravenous fentanyl, 2 µg / kg and propofol 1 - 2 mg / kg. Endotracheal intubation was achieved by cis-atracurium, 0.15 mg / kg. Maintenance of anesthesia was done by isoflurane and cis-atracurium, 0.03 mg / kg on demand. Additional intraoperative analgesia was consisted of administration of intravenous boluses of fentanyl, 50 µg according to the attending anesthesiologist's decision. At the end of surgery, muscle relaxation was reversed using neostigmine 0.05 mg / kg and atropine 0.01 mg / kg."
15911749|NCT03560414|Procedure|simple plasma exchange|simple plasma exchange treatment
15911750|NCT03560414|Procedure|conventional PDF treatment group|conventional PDF treatment group
15911751|NCT03560414|Procedure|less plasma PDF treatment group|less plasma Plasma diafiltration treatment
15911752|NCT03560401|Device|Knight-Taylor [chairback] brace|Knight-Taylor [chairback] brace, is one kind of rigid lumbosacral orthosis. The manufacturer was Rehabilitation and Technical Aid Center, Taipei Veterans General Hospital.
15911753|NCT03560388|Other|Acupuncture and touch/relaxation|Pre-operative integrative care (touch-relaxation) that follows with intra-operative acupuncture
15911754|NCT03560375|Behavioral|Circuit resistance training (CRT)|"Subjects will be allocated to CRT which consists of 10 resistance exercises for different body parts (=1 circuit) repeated 12-15 times, using modest weights (approximately 40-60% of one repetition maximum, RM). Each exercise is expected to be completed within 30-40 sec. The participant will move quickly (within 15-30 seconds) from one exercise to the next. The circuit will be repeated up to three times depending on the week of intervention. Thus, it will take about 30 min to complete an exercise session. For a summary of articles on CRT in older adults based on a meta-analysis, we performed please see:
~Circuit resistance training is an effective means to enhance muscle strength in older and middle-aged adults: A systematic review and meta-analysis. Ageing Res Rev. 2017 Aug;37:16-27"
15911755|NCT03560375|Behavioral|Vegeterranean diet (V-Med diet)|The modified V-Med diet will be considered as ad-libitum (using fat sources) aimed for a minimum of 1 gr/kg/day of protein, limiting carbohydrates: 3 servings for men and 2 servings for women per main meal and 1 serving per intermediate meal for both genders. Subjects will be asked to avoid red meat and poultry completely and the consumption of dairy and eggs products will be limited to 2 servings per day. 2-3 servings of fish should be consumed during the week. The rest of protein consumption will be recommended from legumes sources. The target legume consumption will be 1.5 cup per day (2 servings per day) of cooked beans, chickpeas, lentils and/or using pulses-based flour or pulses-based bread. Consumption of whole grain carbohydrate foods will be recommended.
15911756|NCT03560375|Drug|Empagliflozin 10 MG|Subjects allocated to empagliflozin will be asked to add empagliflozin 10mg, preferably in the morning, to their medication regimen. Subjects will be monitored for adverse events including hypoglycemic events during all study visits.
15911757|NCT03560362|Drug|Bupivacaine liposome|
15911758|NCT03560362|Drug|Bupivacaine / Epinephrine|
15911759|NCT03560349|Drug|Lidocaine HCl Gel 2%|"Patients will be prescribed a regimen of 1 g acetaminophen q 8hrs alternating with 600 mg ibuprofen q 6 hours. In addition they will be instructed to continue oral fluid hydration and minimal activity for 24 hours.
~At 2-hours following the SPG blockade an EBP will be offered to patients. Patient will also be informed that they can request an EBP at any time. The SPG blockade will be performed twice daily in the hospital and twice daily at home, by the patient. The patient will also be informed, if that at anytime, they would like an EBP, it can be provided.
~While the study is being conducted, patients will not be offered a SPG block unless enrolled in the study."
15911760|NCT03560349|Drug|placebo gel|"Patients will be prescribed a regimen of 1 g acetaminophen q 8hrs alternating with 600 mg ibuprofen q 6 hours. In addition they will be instructed to continue oral fluid hydration and minimal activity for 24 hours.
~At 2-hours following the SPG blockade an EBP will be offered to patients. Patient will also be informed that they can request an EBP at any time. The SPG blockade will be performed twice daily in the hospital and twice daily at home, by the patient. The patient will also be informed, if that at anytime, they would like an EBP, it can be provided.
~While the study is being conducted, patients will not be offered a SPG block unless enrolled in the study."
15911761|NCT03560336|Drug|Liraglutide|Patients will initiate treatment with liraglutide according to the approved label in Korea. Patients will initiate 0.6 mg daily and weekly increase the dose by 0.6 mg until reaching 3.0 mg daily. Patients will then continue to stay on 3.0 mg/day (total treatment duration: 26 weeks).
15911762|NCT03560323|Drug|Beta-hydroxy-butyrate|"Following completion of the baseline MRI and blood samples, subjects will be divided into three groups (12 subjects per group). Each group will receive a 6-hour (3-hour in group III) prime-continuous infusion of racemic B-OH-B (100 mg/mL solution; pH adjusted to 7.4) to increase the plasma B-OH-B concentration by 0.5, 2.0, and 5.0 mmol/L.
~GROUP I: Prime = 0.4 mg/kg.min for 20 minutes and constant rate = 0.2 mg/kg.min until study end GROUP II: Prime = 1.5 mg/kg.min for 20 minutes and constant rate = 0.75 mg/kg.min until study end GROUP III: Prime = 4.0 mg/kg.min for 20 minutes and constant rate = 2.0 mg/kg.min until study end"
15911763|NCT03560310|Drug|Ticagrelor 90mg twice daily and ASA 75-100 mg daily|Assess whether ticagrelor 90 mg twice daily and ASA 75-100 mg daily versus ASA 75-160 mg daily improves outcome after isolated coronary artery bypass grafting in patients with acute coronary syndrome
15911764|NCT03560310|Drug|ASA 75-160 mg daily|Assess whether ticagrelor 90 mg twice daily and ASA 75-100 mg daily versus ASA 75-160 mg daily improves outcome after isolated coronary artery bypass grafting in patients with acute coronary syndrome
15911765|NCT03560297|Behavioral|SeRenade Parent-Child Music Class|Parent-Child Music Class involving parent training, peer inclusion, and musical play
15911766|NCT03560297|Behavioral|Delayed Intervention|Participants receive intervention after delay
15911767|NCT03560271|Drug|Cyclo-Z|Cyclo (His-Pro) and zinc
15911768|NCT03560271|Other|Placebo|Matching placebo
15911769|NCT03560258|Biological|p24CE1/2 pDNA vaccine|4 mg administered by one injection/electroporation
15911770|NCT03560258|Biological|p24CE1/2 pDNA vaccine admixed with full-length p55^gag pDNA vaccine|2 mg p24CE1/2 pDNA admixed with 2 mg full-length p55^gag pDNA administered by one injection/electroporation
15911771|NCT03560258|Biological|Full-length p55^gag pDNA vaccine|4 mg full-length p55^gag pDNA vaccine administered by one injection/electroporation
15911772|NCT03560258|Biological|Placebo|1 mL placebo administered by one injection/electroporation
15911773|NCT03560245|Drug|Bryostatin|The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.
15911774|NCT03560245|Other|Placebo|The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the experimental drug
15911775|NCT03560232|Drug|Ceftriaxone|See arm description
15911776|NCT03560232|Drug|Ampicillin/sulbactam|See arm description
15911777|NCT03560232|Drug|Piperacillin/tazobactam|See arm description
15911778|NCT03560232|Drug|Cefazolin + Gentamicin|See arm description
15911779|NCT03560232|Drug|Clindamycin + Gentamicin|See arm description
15911780|NCT03560219|Diagnostic Test|Biomarkers, Cardiac Magnetic Resonance Imaging, Echocardiography, Flow Mediated Dilatation, Genetic Analysis|"Key variables that will be recorded include the following:
~Clinical
~Age
~Gender
~BMI
~Diabetes Mellitus
~Hypertension
~Heart Failure
~Ischemic Stroke / TIA
~Thromboembolism
~Coronary Artery Disease
~Peripheral Arterial Disease
~Glomerular Filtration Rate
~Contrast-enhanced MRI
~o Presence and extent of atrial fibrosis
~Biomarkers
~IL-6
~CRP
~D-dimer
~Fibrinogen
~Transthoracic Echocardiography
~LA Volume Index (LAVI)
~LA Strain, Global
~LA Strain rate, Positive peak, Global
~LA Strain rate, early negative peak, Global
~LA Strain rate, late negative peak, Global
~LA Emptying Fraction (LAEF)
~LVH
~LVEF
~Endothelial function o FMD"
15911781|NCT03560206|Behavioral|Family SWaP intervention with mini iPad|The Family Sodium Watcher Program (Family SWaP) proposed in this study incorporates the use of a unique electronic salt monitoring device that easily measures salt content in food-the major source of sodium. The intervention is designed to improve adherence to a sodium restricted diet by both patients and family caregivers through education and strategies for gradual taste adaptation to low salt foods. The Family SWaP intervention (6 weekly 45-minute sessions followed by 5 bi-weekly booster sessions) will be delivered remotely using a video-conferencing program on an iPad tablet.
15911782|NCT03560206|Behavioral|usual care|The usual care group will receive their routine medical and nursing care for heart failure that consists of a recommendation to follow a sodium restricted diet without explicit skills training to do so.
15911783|NCT03560193|Drug|2%Chlorhexidine-70%Isopropanol|2% Chlorhexidine-70% isopropanol will be used to disinfect the skin before Cardiac Surgery and during all dressing changes
15911784|NCT03560193|Drug|5%Povidone Iodine- 69%Ethanol|5%Povidone Iodine- 69%Ethanol will be used to disinfect the skin before Cardiac Surgery and during all dressing changes
15911785|NCT03560180|Diagnostic Test|Dutch score|leakage score (DUtch LeaKage, DULK), that consider several items (fever, heart rate, respiratory rate, urinary production, mental status, clinical conditions, signs of ileus, gastric retention, fascial dehiscence, abdominal pain, wound pain, leukocytosis, CRP, increase of urea or creatinine and nutrition status), to give a score
15911786|NCT03560180|Diagnostic Test|Serum C-reactive Protein|see study protocol
15911787|NCT03560180|Diagnostic Test|serum Procalcitonin|see study protocol
15911788|NCT03560167|Device|AccuCinch® Ventricular Restoration System|AccuCinch® Ventricular Restoration System in Patients with Prior Mitral Valve Intervention (PMVI) and Recurrent Mitral Regurgitation
15911789|NCT03560154|Other|Whole Body Vibration Training|whole body vibration application will be performed in the range of 25-40 Hz, with amplitude 1-2 mm, 30-60 seconds (30-45 seconds) application and resting times of 60 seconds, 2-5 sets each session. Also, as a home program; respiratory exercises will be taught every day of the week for 10 minutes a day.
15911790|NCT03560141|Device|LID011121 contact lens|Investigational silicone hydrogel contact lens
15911791|NCT03560141|Device|Comfilcon A contact lens|Commercially available silicone hydrogel contact lens
15911792|NCT03560128|Device|Endocuff Vision device|Subjects randomized to undergo a colonoscopy procedure with the Endocuff Vision device will have this device placed on the colonoscope used during their procedure.
15911793|NCT03560128|Device|AmplifEYE device|Subjects randomized to undergo a colonoscopy procedure with the AmplifEYE device will have this device placed on the colonoscope used during their procedure.
15911794|NCT03560115|Diagnostic Test|Single-heel rise test|Single heel-rise test is used to assess the strength of plantar-flexors clinically
15911796|NCT03560089|Device|Serious game|Serious game with movements
15911797|NCT03560089|Device|Placebo serious game|Serious game without movement
15911798|NCT03560076|Other|SBIRT Training and Implementation Strategies|A train-the-trainer approach will be used to train site coordinators on the SBIRT process and implementation strategies.
15911799|NCT03560063|Procedure|Corin Optimised Positioning System|"Total hip replacement with implant positioning guided by Corin Optimised Positioning System.
~The experimental and active comparator arms will use the same implants for total hip replacements. The Corin Trinity shell system will be used for the acetabular system. The Corin MiniHip, TriFit, MetaFix and TaperFit implants will be used for the femoral stem implant. Surgeons will select the implant most appropriate for each patient."
15911800|NCT03560063|Procedure|Standard templating|Total hip replacement with implant positioning guided by standard templating. The experimental and active comparator arms will use the same implants for total hip replacements. The Corin Trinity shell system will be used for the acetabular system. The Corin MiniHip, TriFit, MetaFix and TaperFit implants will be used for the femoral stem implant. Surgeons will select the implant most appropriate for each patient.
15911801|NCT03560050|Behavioral|Nutrition assistance|Participating family child care home providers in and around the Oklahoma City (OKC) area will be randomized to either the Nutrition (n=26), or an environmental health comparison group (n=26). Briefly, the Nutrition Technical Assistance Intervention and comparison group will consist of three encounters with the intervention team: two home-based, 90-minute visits scheduled at the convenience of the family child care home provider and a 3-hour group class session that will be conducted on a weekend. Total contact time with intervention staff will be 6 hours. All participants will receive a toolkit. Providers will complete either intervention over a period of three months.
15911823|NCT03559881|Other|High protein/high dairy|Participants in the interventional group will receive individual dietary instruction on how to achieve at least 1.2 grams of high quality protein / kg of body weight / day, 50% from dairy products, and at least one meal per day consisting of a minimum of 30 g of high quality protein (~14 g of essential amino acids).
15940436|NCT03338010|Drug|LY2963016|Administered SC
15911802|NCT03560050|Behavioral|Children's environmental health|Participating family child care home providers in and around the OKC area will be randomized to either the Nutrition (n=26), or an environmental health intervention (n=26) that will receive an Integrated Pest Management and Green Cleaning intervention with the same format and visit frequency. Briefly, the Intervention will consist of three encounters with the intervention team: two home-based, 90-minute visits scheduled at the convenience of the family child care home provider and a 3-hour group class session that will be conducted on a weekend. Total contact time with intervention staff will be 6 hours. All participants will receive a toolkit. Providers will complete either intervention over a period of three months.
15911803|NCT03560037|Device|Endocuff Vision Assisted Colonoscopy|Detachable device that is fixed to the end of colonoscope. The device has single-row of soft, hair-like projections that flatten colonic folds during colonoscope withdrawal which can aid in detection of colon polyps.
15911804|NCT03560024|Other|PACAP27|PACAP27 is vasodilator of cerebral vessels
15911805|NCT03560024|Other|Placebo|Saline
15911806|NCT03560011|Drug|immunoglobulin IV|5 injections of immunoglobulin IV once a month during 5 months (2g/kg at M1, 1.5g/kg at M2 to M5, maximal dose 100g)
15911807|NCT03559998|Other|lecture|"Empathy (1 hour)
~Doctor- patient relationship (1, 5 hour)"
15911808|NCT03559998|Other|Simulation using Role play|"serious illness announcement
~abuse demand management
~reticent patient management"
15911809|NCT03559998|Other|Discussion group|Share about clinical work experience and elaboration about psychoaffective and relational challenge
15911810|NCT03559998|Other|Simulation using Simulated patient|"HIV announcement
~Refuse of antibiotic prescription"
15911811|NCT03559985|Drug|paracetamol|"Period 1 (D1 to D7): 500 mg (paracetamol or placebo) to be repeated if necessary, depending on the intensity of pain, after 4 hours minimum between each treatment intake, with a maximum dose of 3 g/day, corresponding to 6 capsules per day.
~Wash-out period (D8 to D14): patients should not take paracetamol during this week.
~Period 2 (D15 to D21): 500 mg per dose (paracetamol or placebo) to be repeated if necessary, depending on the intensity of pain, after 4 hours minimum between each treatment intake, with a maximum dose of 3 g/day, corresponding to 6 capsules per day."
15911812|NCT03559985|Other|Placebo comparator|"Period 1 (D1 to D7): 500 mg (paracetamol or placebo) to be repeated if necessary, depending on the intensity of pain, after 4 hours minimum between each treatment intake, with a maximum dose of 3 g/day, corresponding to 6 capsules per day.
~Wash-out period (D8 to D14): patients should not take paracetamol during this week.
~Period 2 (D15 to D21): 500 mg per dose (paracetamol or placebo) to be repeated if necessary, depending on the intensity of pain, after 4 hours minimum between each treatment intake, with a maximum dose of 3 g/day, corresponding to 6 capsules per day."
15911813|NCT03559972|Other|on-label facial injection|Assessing if adding SkinMedica's cosmetic topical skincare regimens improves the appearance of the skin and the subject's experience, when used after pre-elected on-label facial injection
15911814|NCT03559959|Behavioral|Vouchers for HIV self-testing kits|Participants will be given one referral voucher that offers a self-test kit at a randomly selected price point and distribution site. The vouchers will be valid for one month after the enrollment date. The other household members above 16 years of age will also be offered one voucher per person. Vouchers for the same household will have the same price, distributor, and promotion messages.
15911815|NCT03559946|Device|percutaneous tibial nerve stimulation (PTNS)|The PTNS and the sham treatments will be given in 30 min sessions. The PTNS treatment consists of inserting a 34-gauge needle electrode approximately 5 cm cephalad to the medial malleolus and, as well as placing a PTNS surface electrode on the ipsilateral calcaneus. To keep the electrode placement consistent with the sham treatment, 2 inactive transcutaneous electrical nerve stimulation (TENS) surface electrodes are also added, 1 placed under the little toe and 1 on the top of the foot. The PTNS lead set is connected to the Urgent PC stimulator, and a current level of 0.5 to 10 mA at 20 Hz is delivered until the flexion of the big toe is observed or the patient reports a radiating sensation at the sole of the foot.
15911816|NCT03559946|Device|Sham procedure|The sham treatment, involves simulating the sensation of the PTNS needle insertion at the same location using a Steritberger placebo needle. This is a blunt tip needle which simulates the sensation of a needle prick when touched to the skin, however, the blunt tip retracts into the handle when pressed into the skin. This creates the illusion of the needle entering the skin, without breaking the skin's surface. An inactive PTNS surface electrode is also placed on the ipsilateral calcaneus. The two TENS surface electrodes, placed in the same location as the PTNS treatment, are active and deliver stimulation mimicking the sensory effects of the PTNS. However, since no electrode needles were inserted near the tibial nerve, there will be no tibial nerve stimulation
15911817|NCT03559933|Device|PEPNS System|PEPNS System therapy will be delivered periodically up to 48 hours or less if patient is no longer being mechanically ventilated.
15911818|NCT03559920|Drug|Sedate using sevoflurane via anesthetic conserving device(ACD, Anaconda®) after surgery|The investigators sedate the patients in the ICU for several days after head & neck surgery using sevoflurane via anesthetic conserving device in sevoflurane group.
15911819|NCT03559920|Drug|Sedate using propofol.|Retrospectively, the investigators compare the sevoflurane group with intravenous sedation group using propofol.
15911820|NCT03559907|Behavioral|Cooking Matters for Parents|Cooking Matters for Parents focuses on teaching parents of young children important lessons about self-sufficiency in the kitchen. Participants have the opportunity to practice fundamental lessons including knife skills, reading ingredient labels, cutting up a whole chicken, and making a healthy meal for a family of four on a budget of ten dollars. Each session includes meal preparation, didactic teaching, and sharing the meal as a group. Instructors share their education and experience and discuss how to choose healthy, affordable fruits and vegetables at the grocery store. Each week, adults take home a bag of groceries after each class so they can practice the recipes taught that day.
15911821|NCT03559907|Behavioral|Mealtime PREP|Parents are trained to deliver each intervention component during mealtimes using a step-wise, behavioral activation approach. The parent-training prong of the Mealtime PREP intervention incorporates four active ingredients of behavioral activation (1. skills training; 2. goal-setting; 3. activity scheduling; and 4. activity monitoring) to help parents build a family meal routine that is enriched with techniques to promote child food acceptance. Each week, parents will take home healthy groceries to practice making healthy snacks and side dishes in the home.
15911822|NCT03559894|Diagnostic Test|Trans-thoracic echocardiography|Trans-thoracic echocardiography
15911826|NCT03559855|Behavioral|Real Essentials|The REAL Essentials curriculum is a healthy relationship education program for youth developed by the Center for Relationship Education.
15911827|NCT03559829|Device|RAPAEL Smart Glove|The RAPAEL Smart Glove is a commercially available, non-invasive biofeedback based system for distal upper extremity rehabilitation. The Smart Glove is very lightweight and allows for easy movement of all distal upper extremity joints. It is made of an elastomer material that is simple to maintain and clean. The Bending Sensor is a variable resistor that changes as it is bent. The sensor is a 9-axis movement and position sensor that consists of 3 acceleration channels, 3 angular rate channels, and 3 magnetic field channels that measure wrist movements. They are connected to a computer system which can accurately compute the amount of individual finger movements.
15911828|NCT03559816|Other|Classification of perineal tears based on new classification|Classifications according to the American College of Obstetricians and Gynaecologists (ACOG) and the Royal College of Obstetricians and Gynaecologists (RCOG) and sub classification of second-degree lacerations based on the assumption that episiotomy involves the same anatomic structures of a second-degree laceration (perineal muscle, mucosa and skin), and divides them in two sub-groups, named A (if spontaneous vaginal tear is smaller than episiotomy) and B (if spontaneous vaginal tear is bigger than episiotomy).
15911829|NCT03559816|Procedure|Selective use of Episiotomy|Standardized selective use of Episiotomy as recommended by guidelines.
15911830|NCT03559803|Drug|Cisplatin|"Drug: Cisplatin injection Weekly cisplatin (40 mg/m²) will be administered during radiotherapy. At least 3 cycles of cisplatin should be performed according to the hematological and renal functions but not mandatory.
~Combination Product: radiotherapy A total dose of 45Gy in 25 fractions to the PTV is considered standard but simultaneous integrated boost or two steps boost to specific volumes (positive lymph nodes for example) are accepted and left to the investigator's discretion)."
15911831|NCT03559790|Drug|tenofovir alafenamide|To evaluate of efficacy and safety in patients with TDF-TAF switch therapy
15911832|NCT03559777|Other|closed sinus lifting by Osteotome|"Local anesthesia will be injected intra-orally
~A full thickness flap will be elevated
~A pilot drill will be used to start the osteotomy preparation, which should be ended 1mm short of sinus floor.
~The widening drills can be sequentially used to widen the osteotomy site to the same level
~An osteotome of diameter a little less than the planned implant body, will be inserted in the prepared osteotomy site and gently tapped to reach the same level.
~The osteotome will be tapped gently to fracture up the sinus floor.
~Xenograft will be added to the osteotomy as the grafting material.
~Once the desired height of sinus elevation will be gained and grafted, the implant fixture will be inserted.
~Smart peg will be placed on implant and Ostell will be used to record ISQ.
~Healing collar will be placed on implant.
~Suturing the flab around healing collar."
15911833|NCT03559777|Other|closed sinus lifting by Densah bur|"Local anesthesia will be injected intra-orally
~A full thickness flap will be elevated
~A pilot drill will be used to start the osteotomy , which should be ended 1mm short of sinus floor.
~Change the drill motor to reverse- densifying Mode
~with the densah bur (2.5mm) until 1 mm short of the sinus floor.
~Use the next wider Densah Bur (3.0) in densifying-mode until feeling the haptic feedback of the bur reaching the dense sinus floor, modulate pressure with a gentle pumping motion to advance past the sinus floor in 1 mm increments.
~densah burs (3.5mm) advance in the osteotomy.
~Xenograft will be added to the osteotomy .
~Once the desired height of sinus elevation will be gained and grafted, the implant fixture will be inserted.
~Smart peg will be placed on implant and Ostell will be used to record ISQ.
~Healing collar will be placed on implant.
~Suturing the flab around healing collar."
15911834|NCT03559764|Biological|Anti-BCMA CAR T cells|Transparent colorless or slightly yellow liquid
15911835|NCT03559751|Other|VLN cigarettes (A)|0.4mg nicotine / g tobacco king size filter cigarette
15911836|NCT03559751|Other|Usual Brand Cigarettes (B)|Usual brand king size non-menthol cigarettes
15911837|NCT03559751|Drug|Nicotine gum (C)|4 mg nicotine gum
15911838|NCT03559725|Other|VLN menthol cigarettes (A)|0.4mg nicotine / g tobacco king size filter menthol cigarette
15911839|NCT03559725|Other|Usual Brand Menthol Cigarettes (B)|Usual brand king size menthol cigarettes
15911840|NCT03559725|Drug|Nicotine gum (C)|4 mg nicotine gum
15911841|NCT03559712|Other|Collaborative care, Telemental health|Children who are referred to the collaborative tele-mental health care arm, Arm (1), will be given a follow-up appointment with the physician at the same primary care center who have successfully completed the pre-trial didactic program designed by Drs. Albanna and Hamoda. The trained child health physician will conduct assessments, treat and manage the patient. All while having weekly clinical supervision with the specialist.
15911842|NCT03559699|Drug|AG-348|"Part 1 (Dose Optimization Period): All participants will begin by receiving 5 milligrams (mg) orally, twice a day. Each participant's dose of AG-348 may be increased to 20 mg twice a day or 50 mg twice a day depending on their response to AG-348 and their tolerance.
~Part 2 (Fixed Dose Period): Last dose received in Part 1, twice a day."
15911843|NCT03559686|Drug|Certolizumab Pegol|The recommended maintenance dose of Cimzia® (Certolizumab Pegol) for adult patients with Rheumatoid Arthritis (RA) is 200 mg every 2 weeks (single 1 mL injection of 200 mg) .
15911844|NCT03559673|Drug|Lacosamide|Patients will start on the individual Lacosamide (LCM) dose that they had reached at the completion of the previous monotherapy study. LCM will be administered orally twice daily in 2 divided doses.
15911845|NCT03559660|Drug|Certolizumab Pegol|
15911846|NCT03559647|Drug|Atezolizumab|Atezolizumab will be administered per the Summary of Product Characteristics (SmPC) from the European Medicines Agency (EMA).
15911847|NCT03559634|Diagnostic Test|Intervention Group|The electronic application will collect screening health information and contraceptive preferences about the participant. Then, using branch logic, decide which contraceptive options the participant would qualify for based on health history answers. Contraceptive choices being offered include the contraceptive implant, injection, pill, patch, or ring. They will then be able to watch videos about methods they are eligible for. The participant can then decide if they would like to start a medication they qualify for in the ED.
15911848|NCT03559634|Other|Control Group|The electronic application will collect screening health information and contraceptive preferences about the participant. Then, using branch logic, decide which contraceptive options the participant would qualify for based on health history answers. This includes the contraceptive implant, injection, pill, patch, or ring. They will then be able to watch videos about methods they are eligible for. Participants will then be given follow up information on outpatient locations where they can receive these contraceptive methods.
15911849|NCT03559621|Behavioral|mobile-based lifestyle intervention|one face-to-face coaching within 2 weeks after randomization, monthly telephonic coaching -and continuous use of the app as needed
15911850|NCT03559595|Behavioral|Project Prevent|The Project Prevent intervention entails 1) a media campaign to raise PrEP awareness, 2) geographically targeted education initiatives with medical personnel to increase access to consumers, and 3) programming with AIDS service organizations to improve service delivery around PrEP.
15911851|NCT03559569|Biological|Biological samples will be done to evaluate the endothelial and leukocyte senescence.|Noninvasive, reproducible, and sensitive methods to measure cardiac function, endothelial function, and arterial stiffness will be assess.
15911852|NCT03559556|Other|CT angiography|CT angiography uses a CT scanner to produce detailed images of both blood vessels and tissues in various parts of the body. An iodine-rich contrast material (dye) is usually injected through a small catheter placed in a vein of the arm.
15911854|NCT03559530|Drug|Antimicrobial|Antimicrobial therapy according to A. baumannii susceptibility profile
15911855|NCT03559517|Biological|Ontamalimab|Subcutaneous injection of ontamalimab will be administered using a prefilled syringe.
15911856|NCT03559517|Other|Placebo|Subcutaneous injection of placebo matched with ontamalimab will be administered using a prefilled syringe.
15911857|NCT03559504|Drug|Sevoflurane Inhal Soln|Anesthesia will be induced by sevoflurane inhalation only with a tight-fitting facemask and a 4-l airflow of 100% oxygen. Sevoflurane inhalation will be adjusted in all age groups to maintain 1.0 MAC concentration
15911858|NCT03559491|Drug|Intravitreal injection|Long term release steroid injection
15911859|NCT03559478|Procedure|Sharp dissection with scalpel plus electrocautery to vessels|A scalpel will be used for dissection for TKA implantation. Bleeding vessels will be managed as encountered with electrocautery. Electrocautery will not be used for dissection.
15911860|NCT03559478|Procedure|Electrocautery for all dissection|Skin incision will be made with a scalpel, but all other dissection will be performed with electrocautery.
15911861|NCT03559465|Procedure|skin biopsy|"A skin biopsy will be performed in 10 patients in the form of 2 punches of 5 mm in the injured area in aseptic condition with a Rodnan score.
~In this study, 10 skin biopsies are needed, and will be performed on the first 10 patients accepting this biopsy."
15911862|NCT03559465|Other|Blood punction|1 blood punction during the normal pathway of care of the patient. This punction will be used to perform the extraction of B lymphocyte
15911863|NCT03559452|Procedure|Eccentric exercise|300 eccentric contractions of the knee extensors
15911864|NCT03559439|Biological|CD19 CAR T|CD19 CAR T cells transduced with a lentiviral vector to express anti-CD19 scFv CD3z:CD28 administered by IV infusion. Subjects will receive 0.1-10 x 10^6 transduced CAR T cells as a split dose over three days as follows:Day 1, 10% fraction, Day 2, 30% fraction, Day 3, 60% fraction.
15911865|NCT03559426|Drug|Antipsychotic Reduction|Antipsychotic medication is gradually reduced and discontinued if possible. A flexible individualised antipsychotic reduction schedule is devised for each patient by the research team, based on the participant's initial antipsychotic regime. Antipsychotic dose is reduced incrementally every two months, with flexibility to speed up or slow down the schedule in discussion with the patient. The antipsychotic reduction extends over a period of between six to 12 months, although this may be extended according to individual circumstances.
15911866|NCT03559426|Drug|Antipsychotic Maintenance|Participants continue to receive antipsychotic treatment at the original dose for the 24 month duration of the trial. Increases or minor adjustments to antipsychotic medication are permitted.
15911867|NCT03559413|Biological|Individual peptide vaccination with adjuvant GM-CSF and Imiquimod|Intradermal injection of a cocktail of 3-5 individual HLA-binding peptides. Subcutaneous injection of adjuvant GM-CSF at vaccination site. Topical administration of Imiquimod at vaccination site.
15911868|NCT03559400|Drug|local gentamicin injection|Treatment includes debridement and administration of the local antibiotic which will consist of 80mg of liquid gentamicin diluted in 40mL normal saline injected after inserting a 22 gauge needle down to bone after wound closure. The injection will continue until either all 40cc are injected or there is fluid extravasation from the wound.
15911869|NCT03559400|Drug|placebo saline injection|Treatment includes debridement and administration of the local antibiotic which will consist of 40mL normal saline injected after inserting a 22 gauge needle down to bone after wound closure. The injection will continue until either all 40cc are injected or there is fluid extravasation from the wound.
15911870|NCT03559387|Drug|ANF-RHO™|"Subjects randomized to the ANF-RHO™ treatment arm will receive the investigational product on Day 1(day of chemotherapy treatment) of each Chemotherapy cycle. ANF-RHO™ will be administered to the subjects as a subcutaneous injection. Subjects will receive the ANF-RHO™ dose with a volume equivalent to 10 µg/kg, 20 µg/kg and 30 µg/kg.
~ANF-RHO™ is provided as a single-use glass vial containing 1.0 ml of solution at a concentration of 5 mg/ml"
15911871|NCT03559387|Drug|Neulasta®|"Subjects randomized to the Neulasta® treatment arm will receive the comparator drug on Day 2(day after chemotherapy treatment) of each Chemotherapy cycle. Neulasta® will be administered to the subjects at a standard dose of 6.0 mg in 0.6 ml as a subcutaneous injection.
~Neulasta® is also provided as a single-use pre-filled syringe."
15911872|NCT03559374|Other|Vanadis NIPT system|A novel cost effective not NGS (next-generation sequencing) test, based on imaging single DNA molecules for high precision NIPT (non-invasive prenatal testing)
15911873|NCT03559361|Dietary Supplement|EPA-rich|6 months omega 3 supplementation
15911874|NCT03559361|Dietary Supplement|DHA-rich|6 months omega 3 supplementation
15911875|NCT03559361|Dietary Supplement|Olive oil Placebo|6 months placebo supplementation
15911876|NCT03559348|Drug|chemotherapy: TS-1, Leucovorin and Gemcitabine|Gemcitabine 800 mg/m2 , on day 1 S-1 80, 100 or 120 mg/d, orally twice daily on day 1 - 7; Leucovorin 60 mg/d, orally twice daily on day 1 - 7; Every 14 days as one cycle.
15940437|NCT03338010|Drug|Lantus®|Administered SC
15911877|NCT03559322|Device|iNAP® Lite Sleep Therapy System|Class II intraoral devices for snoring and/or obstructive sleep apnea
15911878|NCT03559309|Diagnostic Test|Magnet Resonance Tomography, Carotid Arteries Sonography, Flow-mediated Dilation, Fat-tolerance Test, Laboratory Testing|Patients treated with Alirocumab in the clinical routine will have additional diagnostic tests as stated above. The clinical trial will be conducted as an open label, single arm study. The diagnostic tests will be done at baseline (BL) and after 10 weeks of treatment (W10) with Alirocumab.
15911879|NCT03559296|Diagnostic Test|Ultrasonographic assessment of postmastectomy lymphedema|Qualitative assessment of postmastectomy lymphedema via ultrasound (Subcutaneous echogenicity (SEG) and subcutaneous echo-free space (SEFS) grade systems for postmastectomy lymphedema) and circumferential tape measures ( The circumferential measurement of affected arm at MCP joint, wrist joint, 15 below elbow joint, elbow joint 15cm above elbow point) to assess upper extremity volume
15911880|NCT03559283|Diagnostic Test|Walking and Record Cortical Activity|"The cortical activity of each patient is recorded by NIRS under the following conditions:
~Simple task : The patient walks on an electronic walking track (GAITRite system) over 10 meters. The data collected are the spatio-temporal parameters of walking.
~Cognitive task alone : two conditions of the n-back test (1-back and 2-back) to study neural activities related to working memory. The duration of realization will be 30 seconds by condition and we retain the number of errors realized.
~Double Task : Achievement of the motor task (10-meter walk) is performed at the same time as a weak cognitive task (1-back) and a high cognitive task (2-back). The spatio-temporal parameters and the number of errors are collected by the observer."
15911881|NCT03559270|Drug|Baricitinib|Administered orally
15911882|NCT03559257|Drug|Galcanezumab|Administered SC.
15911883|NCT03559257|Drug|Placebo|Administered SC.
15911884|NCT03559244|Other|Dynamic compression brace|custom-fitted brace adjusts the pressure on the thoracic wall and enables lateral expansion of the thorax
15911885|NCT03559244|Other|Exercises|posture exercises, deep breathing exercises, exercises for manipulation and mobilization of ribs, and core exercises
15911886|NCT03559231|Procedure|dFTRD|Duodenal Full-Thickness Resection
15911887|NCT03559231|Procedure|EMR|Endoscopic Mucosal Resection
15911888|NCT03559218|Device|KeraStat(R) Cream|KeraStat Cream is a cream wound dressing that contains 5% keratin.
15911889|NCT03559218|Other|Standard of care|Patients will be instructed to follow institutional standard of care for radiation dermatitis
15911890|NCT03559205|Other|MSK-Tracker|"The intervention is not a treatment, but involves patients and clinicians engaging with the MSK-Tracker software which will facilitate a new care planning approach with the following distinct components:
~Pre-clinic preparation.
~Clinic dashboard.
~Summary action plan.
~Personal goal setting.
~Follow-up and monitoring."
15911891|NCT03559192|Drug|JNJ-67953964|JNJ-67953964 10 mg will be administered as two 5-mg capsules orally once daily.
15911892|NCT03559192|Drug|Placebo|Matching placebo will be administered as 2 capsules orally once daily.
15911893|NCT03559179|Other|Opioid Wizard|The Opioid Wizard is an OUD clinical decision support tool for primary care providers.
15911894|NCT03559166|Drug|BLD-2660|Randomized to active product or placebo
15911895|NCT03559153|Other|Shiatsu massage|The shiatsu massage will be during the rest break by 15 minutes.
15911896|NCT03559153|Other|Physical Exercise|The Physical Exercise will be during the rest break by 15 minutes.
15911897|NCT03559140|Procedure|Applied saline solution at 2.5 oC (Cryotherapy group)|Patients assigned to this group will receive a final irrigation (application of cryotherapy) with 5 mL cold (8oC) 17% EDTA followed with 20 mL cold (8oC) sterile saline solution delivered to the WL using a cold (8oC) sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 minutes.
15911898|NCT03559140|Procedure|Applied saline solution at 8oC (Cryotherapy )|Patients assigned to this group receive a final irrigation (application of cryotherapy) with 5 mL cold (2.5oC) 17% EDTA followed with 20 mL cold (2.5oC) sterile saline solution delivered to the WL using a cold (2.5oC) sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 minutes.
15911899|NCT03559140|Procedure|Applied saline solution at room temperature (No cryotherapy)|Patients assigned to this control group were treated identically to the experimental groups, except that they will receive a final irrigation ( application of irrigant at room temperature) with 5 mL (room temperature) 17% EDTA followed with 20 mL (room temperature) sterile saline solution delivered to the WL using a sterile microcannula attached to the Endo Vac System (Kerr Endo) for 5 minutes.
15911900|NCT03559127|Procedure|For the Group A. Applied Cryotherapy at 6 oC|Patients assigned to this group receive a final irrigation with 5 mL cold (6 oC) 17% EDTA followed with 20 mL cold (6 oC) sterile saline solution dispensed to the WL using a cold (6 oC) metallic micro-cannula included in the Endo Vac System (Kerr Endo) for 5 minutes.
15911901|NCT03559127|Procedure|For the Group B. Applied Cryotherapy at 2.5 oC|Patients assigned to this group receive a final irrigation with 5 mL cold (2.5 oC) 17% EDTA followed with 20 mL cold (2.5 oC) sterile saline solution dispensed to the WL using a cold (2.5 oC) metallic micro-cannula included in the Endo Vac System for five minutes.
15911902|NCT03559127|Procedure|Control Group (CG). Applied irrigant at room temperature|Patients assigned to this control group were treated identically to the experimental groups, except that receive a final flush with 5 mL (room temperature) 17% EDTA followed with twenty mL (room temperature) sterile saline solution delivered to the WL using a metallic micro-cannula included in the Endo Vac System for five minutes.
15911903|NCT03559114|Drug|Dalteparin|Dalteparin in prophylactic doses administered daily if screening criteria are satisfied.
15911904|NCT03559114|Drug|Saline|Saline in prophylactic doses administered daily if screening criteria are satisfied.
15911905|NCT03559101|Other|Distilled water|"Commercially available beverage
~Subjects collect all morning urine and drink 500 milliliters of water. Baseline vital measurements (heart rate, blood pressure, oral temperature) and body weight collected Baseline blood samples and urine collected Beverage pretreatment consumed (1 liter over 30 minutes) Body weight measured and blood and urine collected at 5 minutes, 10 minutes, 15 minutes, and then every 30 minutes for 4 hours post beverage consumption"
15911944|NCT03558841|Other|Gait training with the THERA-Trainer Lyra|Gait training with the THERA-Trainer Lyra end-effector gait trainer 3x/week during the inpatient and the outpatient periods.
15911945|NCT03558841|Other|Physical therapy|Conventional geriatric rehabilitation physical therapy (6x/week) during the inpatient period. After discharge home, discontinuation of physical therapy.
15911906|NCT03559101|Other|Medical Food 1|"Commercially available beverage
~Subjects collect all morning urine and drink 500 milliliters of water. Baseline vital measurements (heart rate, blood pressure, oral temperature) and body weight collected Baseline blood samples and urine collected Beverage pretreatment consumed (1 liter over 30 minutes) Body weight measured and blood and urine collected at 5 minutes, 10 minutes, 15 minutes, and then every 30 minutes for 4 hours post beverage consumption"
15911907|NCT03559101|Other|Medical Food 2|"Commercially available beverage
~Subjects collect all morning urine and drink 500 milliliters of water. Baseline vital measurements (heart rate, blood pressure, oral temperature) and body weight collected Baseline blood samples and urine collected Beverage pretreatment consumed (1 liter over 30 minutes) Body weight measured and blood and urine collected at 5 minutes, 10 minutes, 15 minutes, and then every 30 minutes for 4 hours post beverage consumption"
15911908|NCT03559101|Other|Pedialyte|"Commercially available beverage
~Subjects collect all morning urine and drink 500 milliliters of water. Baseline vital measurements (heart rate, blood pressure, oral temperature) and body weight collected Baseline blood samples and urine collected Beverage pretreatment consumed (1 liter over 30 minutes) Body weight measured and blood and urine collected at 5 minutes, 10 minutes, 15 minutes, and then every 30 minutes for 4 hours post beverage consumption"
15911909|NCT03559101|Other|Gatorade|"Commercially available beverage
~Subjects collect all morning urine and drink 500 milliliters of water. Baseline vital measurements (heart rate, blood pressure, oral temperature) and body weight collected Baseline blood samples and urine collected Beverage pretreatment consumed (1 liter over 30 minutes) Body weight measured and blood and urine collected at 5 minutes, 10 minutes, 15 minutes, and then every 30 minutes for 4 hours post beverage consumption"
15911910|NCT03559088|Other|Migraine App|Smart phone app used to report migraine burden to the EHR.
15911911|NCT03559062|Drug|TEZ/IVA|Participants weighing <40 kg received TEZ 50 mg/IVA 75 mg FDC tablet and those weighing ≥40 kg received TEZ 100 mg/IVA 150 mg FDC tablet.
15911912|NCT03559062|Drug|IVA|Participants weighing <40 kg IVA 75 mg tablet and those weighing ≥40 kg received IVA 150 mg tablet.
15911913|NCT03559062|Drug|Placebo|Placebo matched to TEZ/IVA FDC
15911914|NCT03559062|Drug|Placebo|Placebo matched to IVA
15911915|NCT03559049|Drug|Pembrolizumab|200mg IV every 21 days
15911916|NCT03559049|Drug|Pemetrexed|500mg/m^2 IV every 21 days
15911917|NCT03559049|Drug|Carboplatin|AUC 5 IV every 21 days
15911918|NCT03559049|Drug|Rucaparib|600mg PO, BID days 1-21 of each 21 day cycle
15911919|NCT03559036|Procedure|Locomotor Training|Body-weight supported stepping on a treadmill.
15911920|NCT03559023|Procedure|Ultrasound Only|The anesthesia team will use ultrasound to scan on subject's upper back (thoracic spine) to identify a place to begin the epidural procedure. A pen will be used to place markings on subject's back.
15911921|NCT03559023|Procedure|Manometry Only|The anesthesia team will use an extra piece of tubing to confirm the epidural space one the epidural space is established.
15911922|NCT03559023|Procedure|Ultrasound Plus Manometry|The anesthesia team will use both ultrasound and manometry to assist with epidural placement.
15911923|NCT03559023|Procedure|Usual Care/Management|"The epidural will be placed using the usual technique utilized by the anesthesiology department. The the usual care/management group will receive a sham (fake) ultrasound exam of subject's upper back with fake pen markings placed on subject's back. The ultrasound machine will not be turned on."
15911924|NCT03559010|Drug|Norgestrel 0.075 mg tablets|"All subjects enrolled in the use phase of this open-label study will be given the opportunity to purchase and take one Norgestrel 0.075 mg tablet daily up to 16 weeks.
~Subjects will use the investigational product based on their understanding of the directions on the outer packaging called the Drug Facts Label and information inside the product packaging called the Consumer Information Leaflet."
15911925|NCT03558997|Drug|Dupilumab|Dupilumab was administered SC in a single-use, pre-filled glass syringe
15911926|NCT03558997|Drug|Timothy Grass SCIT|Timothy grass extract was administered SC.
15911927|NCT03558997|Drug|Placebo matching dupilumab|Placebo matching dupilumab was prepared in the same formulation without the addition of protein
15911928|NCT03558997|Drug|Placebo matching SCIT|Placebo matching SCIT was prepared in the same formulation (SCIT diluent) without the addition of Timothy grass extract
15911929|NCT03558984|Drug|D-PLEX|D-PLEX is a new formulation of extended release of Doxycycline (active ingredient)
15911930|NCT03558984|Other|Standard of Care|"The SOC prophylactic antibiotic treatment will be consistent and standardized for all sites in the clinical study. is based on The society of thoracic surgeons practice guideline series: antibiotic prophylaxis in cardiac surgery, part II: antibiotic choice."
15911931|NCT03558971|Drug|Cortisol|Participants determine when to administer 5-day regimens of cortisol
15911932|NCT03558958|Drug|P-188 NF|Poloxamer administered daily via sc injection at 5 mg/Kg
15911933|NCT03558945|Biological|Personalized neoantigen vaccine|"Personalized neoantigen vaccines will be injected on day 1 of weeks 1, 3, 5, 7, 9, short interval or 1-2 months after the end of their post-operative chemotherapy, and two boosts will be on day 1 of weeks 12, 20.
~Vaccines will be given in a total volume of up to 1.0ml/shot consisting of 0.3mg peptide+0.5mg ployICLC injected subcutaneously into two to four separate sites of the subject's thighs."
15911934|NCT03558932|Diagnostic Test|pleural biopsy|diagnostic sampling
15911935|NCT03558919|Drug|Mirabegron 25mg|
15911936|NCT03558919|Drug|Solifenacin Succinate 5 MG|
15911937|NCT03558893|Behavioral|Forced Desynchrony|All sleep opportunities and other activities will be scheduled by the experimenter so that by the end of the study these activities are spread evenly across all phases of the internal body clock.
15911938|NCT03558880|Procedure|Erector Spinae Plane Block|Erector Spinae Plane Block was performed
15911939|NCT03558880|Procedure|Tumescent Anesthesia|Tumescent Anesthesia was applied
15911940|NCT03558867|Drug|Metformin + Healthy diet|Metformin (1500 mg/d, Extended Release) + Healthy, low fat diet
15911941|NCT03558867|Drug|Metformin + Personalized diet|Metformin (1500 mg/d, Extended Release) + Algorithm-based personalized diet
15911942|NCT03558854|Drug|Acetylsalicylic acid|Patients will be randomized to take one pill of either acetylsalicylic acid or placebo once daily for 4 weeks
15911943|NCT03558854|Drug|Placebo oral capsule|Patients will be randomized to take one pill of either acetylsalicylic acid or placebo once daily for 4 weeks
15913470|NCT03547232|Drug|Indomethacin SR|Indomethacin SR 50mg given q12h from admission day 1 to day 7
15911946|NCT03558828|Behavioral|Step 1: PA Monitor|The participant will receive an enhanced physical activity monitor treatment for weeks 1-8, which includes goal setting with a physical activity prescription, and self-monitoring with a physical activity monitor.
15911947|NCT03558828|Behavioral|Step 1: PA Monitor + Text|"The participant will receive an enhanced physical activity monitor treatment for weeks 1-8, which includes goal setting with a physical activity prescription, and self-monitoring with a physical activity monitor.
~In addition, these participants will receive motivational text messages. For participants who remain less than halfway to their daily step goal by a designated daily time, a motivational text message with a strategy to overcome barriers will be sent."
15911948|NCT03558828|Behavioral|Step 2: PA Monitor with Calls|"Nonresponders to the enhanced physical activity monitor, will receive an augmented treatment.
~The participant will continue to receive an enhanced physical activity monitor treatment for weeks 9-34.
~In addition they will receive ten brief motivational telephone calls, made by an interventionist, every two to three weeks during weeks 9-34."
15911949|NCT03558828|Behavioral|Step 2: PA Monitor with Meetings|"Nonresponders to the enhanced physical activity monitor, will receive an augmented treatment.
~The participant will continue to receive an enhanced physical activity monitor treatment for weeks 9-34.
~In addition, the participant will take part in five 45-minute group meetings held every four to six weeks during Weeks 9-34."
15911950|NCT03558828|Behavioral|Step 2: PA Monitor + Texts with Calls|"Nonresponders to the enhanced physical activity monitor plus text messaging, will receive an augmented treatment.
~The participant will continue to receive an enhanced physical activity monitor treatment for weeks 9-34.
~In addition, these participants will continue to receive motivational text messages. For participants who remain less than halfway to their daily step goal by a designated daily time, a motivational text message with a strategy to overcome barriers will be sent.
~In addition they will receive ten brief motivational telephone calls, made by an interventionist, every two to three weeks during weeks 9-34."
15911951|NCT03558828|Behavioral|Step 2: PA Monitor + Texts with Meetings|"Nonresponders to the enhanced physical activity monitor plus text messaging, will receive an augmented treatment.
~The participant will continue to receive an enhanced physical activity monitor treatment for weeks 9-34.
~In addition, these participants will continue to receive motivational text messages. For participants who remain less than halfway to their daily step goal by a designated daily time, a motivational text message with a strategy to overcome barriers will be sent.
~In addition, the participant will take part in five 45-minute group meetings held every four to six weeks during Weeks 9-34."
15911952|NCT03558828|Behavioral|Step 3: PA Monitor|During Weeks 35-50, all women will receive enhanced physical activity monitors only.
15911953|NCT03558802|Other|questionnaire|questionnaire
15911955|NCT03558776|Dietary Supplement|linseed oil|linseed oil and defined background diet
15911956|NCT03558763|Device|Telemonitoring|During the telemonitoring treatment period the subjects will register; vital functions (blood pressure, heart rate, weight, SpO2) twice a week, physical movement daily by using a fitness device, have video calls with a nurse weekly the first 4 weeks and thereafter every fourth week the last 5 months. Twice a week (± 2 days) questionnaires (CAT and MRC) should be filled out at home.
15911957|NCT03558763|Other|Normal Care|During normal care the subjects will get the possibility to call the COPD-center via telephone on their own initiative e g with worsening symptoms as usual.
15911958|NCT03558750|Biological|Nivolumab|Given by IV
15911959|NCT03558750|Biological|Rituximab|Given by IV
15911960|NCT03558750|Drug|Lenalidomide|Given by mouth
15911961|NCT03558737|Other|Nasal high-frequency jet ventilation (nHFJV)|Non-invasive high-frequency jet ventilation provided via the Bunnell Life Pulse high-frequency JET ventilator through a Rusch latex nasopharyngeal airway
15911962|NCT03558737|Other|Nasal intermittent positive pressure ventilation (NIPPV)|Non-invasive positive pressure ventilation delivered via a conventional ventilator through Hudson prongs
15911963|NCT03558724|Drug|Bevacizumab-IRDye800CW|Intravenous administration of 4.5, 10 or 25 mg of Bevacizumab-IRDye800CW prior to the endoscopic procedure
15911964|NCT03558724|Device|Molecular Fluorescence Endoscopy platform|A flexible fluorescence fiber-bundle is attached to a fluorescence camera platform to enable the detection of fluorescence signals. The fluorescence fiber-probe is inserted through the standard working channel of the standard clinical endoscope. Fluorescence imaging will be performed prior to and post the chemoradiotherapy.
15911965|NCT03558711|Diagnostic Test|18F-PSMA|18F-PET imaging
15911966|NCT03558698|Other|Good ventilation|Good ventilation with a low concentration of CO2
15911967|NCT03558698|Other|Ventilation CO2|CO2 High and Good ventilation
15911968|NCT03558698|Other|Poor Ventilation|Poor ventilation with high concentrations of CO2 and bio effluents
15911969|NCT03558685|Behavioral|Weight loss diet|Nutritional recommendation consisted of moderate caloric restriction, set at 25% to 30% less than calories needed for resting metabolic rate. We applied a high protein Mediterranean diet with the following food group distribution: 30% as protein (> 0.8 g/kg/d); 40% as carbohydrates with medium/low glycemic index; 30% as fat (≥10% monounsaturated fatty acid, ≤7% saturated fatty acid, no trans fats, and 1.6 g omega-3 for men and 1.1 g omega-3 for women). Diet was rich in olive oil, fish, chicken, nuts, white milk products, fruits, and vegetables but low in artificial sugars, commercial sweets, pastries, butter, margarine, and red meat. Dietary fiber content ≥25 g/day
15911970|NCT03558672|Device|Flexitouch system with Head and Neck Garments|Flexitouch system or Flexitouch Plus Head and Neck Treatment, as prescribed
15911971|NCT03558659|Device|Positional therapy belt|The positional therapy belt produced by SlumberBUMP will be used by stroke patients during sleep, which helps to avoid sleep in the supine position.
15911972|NCT03558646|Other|There is no intervention planned (observational)|There is no intervention planned (observational)
15911973|NCT03558620|Procedure|mask ventilation|mask ventilation (one-handed ventilation, one-handed with an endoscopic bite block, and two-handed ventilation)
15912007|NCT03558347|Device|short implants with splinted crowns|7 mm short implants (CONELOG® Implant System), individualized titanium abutments, splinted lithium disilicate crowns
15912008|NCT03558347|Device|short implants with non-splinted crowns|7 mm short implants (CONELOG® Implant System), individualized titanium abutments, non-splinted lithium disilicate crowns
15912624|NCT03553953|Device|BIS device|Recording data from BIS device from patients who undergo elective surgery under general anesthesia
15911974|NCT03558607|Drug|Ruxolitinib|"Induction chemotherapy include combination of cytarabine (200mg/m2) and idarubicin (12mg/m2). Both 7+3 and 5+2 regimen is allowed according to age and performance status (PS) as follows;
~If Age < 55 years and ECOG PS < 2 : 7+3 regimen
~If Age ≥ 55 years or ECOG PS = 2 : 5+2 regimen
~Ruxolitinib is administered for 14 days during induction/consolidation phase. After complete remission after induction, ruxolitinib is administered for the first 14 days during consolidation chemotherapy. Maximum 3 cycles of consolidation is recommended. In case of allogeneic stem cell transplantation (alloSCT), ruxolitinib is discontinued at the time of transplantation. After completion of consolidation, 2 years of ruxolitinib maintenance is planned. The follow-up period is from the time of enrollment until 24 months."
15911975|NCT03558594|Behavioral|Hypnosis|Behavioral Condition
15911976|NCT03558594|Behavioral|Mindfulness|Behavioral Condition
15911977|NCT03558581|Other|Educational|
15911978|NCT03558568|Device|Deep Brain Stimulation|Deep Brain Stimulation is an established surgical method for Parkinson's Disease.
15911979|NCT03558555|Drug|Acetaminophen IV Soln|1000mg of IV acetaminophen
15911980|NCT03558555|Drug|Oral Acetaminophen|oral acetaminophen 975mg pills
15911981|NCT03558555|Drug|Placebo Pills|placebo match to acetaminophen
15911982|NCT03558555|Drug|Saline|Intravenous saline
15911983|NCT03558542|Other|cardiopulmonary rehabilitation plus neurorehabilitation|Patients with stroke will undergo an accompanying structured cardiopulmonary rehabilitation program along with a neurorehabilitation program
15911984|NCT03558516|Drug|Magnesium group|We will dilute magnesium 6 gram with 0.9% sodium chloride to 30 ml. The patient will receive magnesium sulfate 40 mg/kg infuse over 30 min started at skin incision and continuous drip 10 mg/kg/hr until the dura is closed. Anesthesia is standardized with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.
15911985|NCT03558516|Drug|Normal saline group|The patient will receive 0.9% sodium chloride the same amount of magnesium sulphate infuse over 30 min started at skin incision and continuous drip until the dura is closed. Anesthesia is standardized with propofol, fentanyl, cisatracurium and sevoflurane. Vasopressor or antihypertensive drug are used to control hemodynamics.
15911986|NCT03558503|Drug|UGN-102|Six (6) intravesical instillations of UGN-102 (1.33 mg) will be given weekly.
15911987|NCT03558490|Device|ZEMY software|"The ZEMY software medical device integrates specific algorithms based on international and validated guidelines. It provides individually customized information and defines for the patient an adapted action to follow for each of the following reported symptoms or anti-cancer treatment-related toxicities: diarrhea, fatigue, nausea, vomiting, cutaneous and mucosal toxicities, pain, fever/febrile neutropenia, high blood pressure, anxiety and depression.
~During the 3-month study period, participants will be asked to enter their symptoms among the 10 symptoms listed in ZEMY on their smartphone dedicated to the study. Consequently, ZEMY software will provide to the participants adapted real-time information to advise them on the management of the experienced symptom and recommend hygienic-dietetic advice and symptomatic treatments."
15911988|NCT03558490|Drug|Investigator's choice of anti-cancer treatment (except immunotherapy)|All anti-cancer treatments (except immunotherapy) will be left to the free choice of investigators. Participants shall be prescribed by the healthcare team both of the following symptomatic treatments: loperamide or any other anti-diarrheic treatment in case of diarrhea; and a prescription for any medication indicated in case of nausea/vomiting. A written prescription will be made by the investigator at screening for loperamide or any other anti-diarrheic treatment and symptomatic treatment for nausea/vomiting with documented dosage and duration.
15911989|NCT03558477|Drug|YYD601 1|YYD601 1
15911990|NCT03558477|Drug|YYD601 2|YYD601 2
15911991|NCT03558477|Drug|YYD601 3|YYD601 3
15911992|NCT03558477|Drug|Nexium|Nexium
15911993|NCT03558464|Dietary Supplement|Intervention (integrated package)|"During whole study (pregnant women and offspring):
~Soap (for daily hand washing)
~Chlorine solution (for daily drinking water treatment)
~Life stage-appropriate (pregnancy, lactation, IYCF) monthly nutrition and WASH trainings
~During pregnancy and up to when offspring turns 6 months old:
~LNS (Enov' Mum, 20g sachet daily)
~Anthelminthic treatment (single-dose mebendazole (500mg), once during second trimester of pregnancy)
~Children 6-24 months of age
~MNP (MixMe, 1g sachet every three days)
~ORS + zinc
~1 egg per day
~All families in the intervention group will receive the same agriculture-focused package (see section 'control intervention' below) as those in the control group. All women will follow regular antenatal care as provided by the Kenyan government as part of their routine health system (e.g. intermittent preventive malaria treatment and iron-folic acid-supplements)."
15911994|NCT03558464|Other|Control|"Active control: The families living in the control clusters will receive the agriculture-focused package that is already in place in all participating clusters through the 1AF programme. This agriculture focused package consists of: - Agricultural training (every 2 weeks on average) for all - Free to enrol for the following products on credit: o Compost boosters
~Cook stoves o Seeds (onions, maize, indigenous greens, beans) o Maize storage bags o Drying tarps
~Trees o Solar lights o Fertilizer o Actellic dust (insecticide) o Re-usable sanitary pads"
15911995|NCT03558451|Other|Complex intervention in sexual health|EXIMe is a complex intervention in sexual health, individualized, in the midwife consultation, where techniques for expression, analysis, information and development of sexual health skills will be used.
15911996|NCT03558451|Other|Usual care|According to available protocols applicable to the patient and the health service standardized portfolio
15911997|NCT03558438|Other|No interventions|No interventions
15911998|NCT03558425|Drug|CKD-381|1 tablet administered before the breakfast during 7 days
15911999|NCT03558425|Drug|D026|1 tablet administered before the breakfast during 7 days
15912000|NCT03558412|Combination Product|CODOX-M/IVAC|Given ivgtt
15912001|NCT03558412|Drug|Decitabine|Given ivgtt
15912002|NCT03558399|Other|FET according to ERA|Single euploid FET will be performed at the time indicated by the ERA test results.
15912003|NCT03558399|Other|FET according to standard protocol|Single euploid FET will be performed according to our standard FET protocol.
15912004|NCT03558386|Behavioral|ePRO survey|An electronic patient reported outcomes survey will be completed by the patient.
15912005|NCT03558373|Drug|Immunosuppressive|Immunosuppressive therapies
15912006|NCT03558360|Diagnostic Test|Impedance measurement|Measurement of dry lean body mass berfore bariatric surgery by impedance measurement.
15912009|NCT03558334|Drug|Transplantation of mesenchymal stem cell|"Human umbilical cord-derived mesenchymal stem cell will be given to preterm infants through intravenous infusion.
~Dose A - 1 million cells per kg Dose B - 5 million cells per kg"
15912010|NCT03558334|Drug|No transplantation of mesenchymal stem cell|Human umbilical cord-derived mesenchymal stem cell will be not given to preterm infants through intravenous infusion.
15912011|NCT03558321|Procedure|Hysteroscopic guided fractional curretage|Under general anaesthesia , evaluation of the endometrial cavity was done followed by biopsy of the whole endometrial tissue
15912012|NCT03558321|Procedure|total abdominal hysterectomy, bilateral salpingo oophrectomy, with or without pelvic lymph nodal dissection|Through abdominal incision , removal of the whole uterus , both tubes and ovaries and in some cases pelvic lymph nodes removal was done
15912013|NCT03558308|Behavioral|Computer based cognitive rehabilitation|Computer based cognitive rehabilitation is a supplementary computerized tool for cognitive rehabilitation design to train various cognitive functions. Many programmes are available. The current study investigates the effects on two such programmes on rehabilitation of executive functions in the chronic phase after acquired brain injury.
15912014|NCT03558308|Other|Sham computerized gaming|Sham training with generally stimulating computer-games
15912015|NCT03558295|Drug|Oral Anticoagulant|warfarin, dabigatran, rivaroxaban, edoxaban
15912016|NCT03558282|Other|Recession Observation|Soft tissue measurements
15912017|NCT03558282|Diagnostic Test|Crown Contour Observation|Ultrasound measures of implant crown contour.
15912018|NCT03558269|Biological|Autlogous UCB infusion|Infants delivered with hypoplastic left heart syndrome and transposition of great arteries undergoing surgery in the 1st 2 weeks of life will be treated with autologous UCB after the surgery. Each group will be followed by MRI before (1-3 days) and after the surgery between at 10 POD. Developmental follow up will be done at 1, 6 and 12 months. Another brain MRI will be done at 6 months of age.
15912019|NCT03558256|Behavioral|Mindfulness-based Cognitive Therapy|Patients participating in the experimental group will receive the MBCT intervention besides the usual medication treatment. The intervention is implemented by the manual adapted from the MBCT for Depression (Segal et al. 2013). The modified version of the program has the same structure with the original manual combined the mindfulness training and the cognitive elements from CBT, but the content is more suitable for the Chinese. The instructors in this study are trained and certificated psychiatrists and psychotherapists with rich experience of working with MDD, and they will receive a weekly supervision conducted by a senior supervisor.
15912020|NCT03558256|Drug|Medication|Both of the MBCT group and the medication group will receive the medication treatment. The initial dose conforms the drug instructions, the dosage can be adjusted once a week, and the maximum dosage should not exceed the maximum amount by the instructions. MDD patients with sleep disorders can use drugs combined with benzodiazepine drugs, but not continuing for more than two weeks; while other psychotropic drugs are not allowed. All of the drugs used in this study are usual clinical drugs with good security, the common adverse reactions include nausea, dry mouth, constipation, diarrhea, indigestion, dizziness, drowsiness, fatigue, sweating, heart palpitations, delayed ejaculation in male, increasing blood aminotransferase without symptoms occasionally and so on.
15912021|NCT03558243|Procedure|Patent Hemostasis arm|Patent hemostasis with TR BAND
15912022|NCT03558243|Procedure|ULTRA arm|Patent hemostasis protocol plus ipsilateral ulnar compression
15912023|NCT03558243|Device|Hemostatic disc arm|StatSeal disc plus TR Band
15912024|NCT03558230|Behavioral|Standardized Constraint-Induced Movement Therapy|The standardized Constraint-Induced Movement Therapy aims to improve the child's weak upper extremity through intensive frequent and repetitive movements. The therapy duration is 6 hours/day for 5 consecutive days.
15912025|NCT03558230|Behavioral|Vibration|Vibration applied to the wrist.
15912026|NCT03558230|Behavioral|Placebo (for vibration)|No vibration applied to the wrist.
15912029|NCT03558204|Procedure|Denervation of the thumb CMC joint|Removal/disconnection of the nerve branches to the joint from their attachments to the joint
15912030|NCT03558204|Procedure|trapeziectomy with ligament reconstruction (LRTI)|excision of the trapezium and suspension of the thumb metacarpal with the flexor carpi radialis tendon
15912031|NCT03558191|Drug|SHR-1210|A humanized monoclonal immunoglobulin PD-1 antibody
15912032|NCT03558178|Procedure|Doin with acupuncture|Doin (conduction exercise) will be performed with the needles in situ by increasing the cervical range of motion (rotation) with physician guidance and isometric resistance exercise as indicated. Doin sessions will be conducted 2 times a week for 5 weeks (total 10 sessions).
15912033|NCT03558178|Device|Acupuncture|Acupuncture will be performed with manual stimulation (needle twirling) to evoke de-qi sensation. Acupuncture sessions will be conducted 2 times a week for 5 weeks (total 10 sessions).
15912034|NCT03558165|Diagnostic Test|Oncomine Comprehensive Assay|Stage IV lung adenocarcinoma patients will have previously biopsied tumor tissue tested with the Oncomine Comprehensive Assay
15912035|NCT03558152|Drug|UTTR1147A|UTTR1147A will be administered intravenously (IV) at dose levels 1, 2, or 3 in Part A, and at the maintenance dose level in Part B, per the respective arm descriptions.
15912036|NCT03558152|Drug|UTTR1147A Placebo|The matching placebo to UTTR1147A (UTTR1147A Placebo) will be administered IV.
15912037|NCT03558152|Drug|Vedolizumab|Vedolizumab will be administered IV, as specified in the prescribing information.
15912038|NCT03558152|Drug|Vedolizumab Placebo|The matching placebo to vedolizumab (Vedolizumab Placebo) will be administered IV.
15912039|NCT03558139|Drug|Magrolimab|Administered intravenously
15912040|NCT03558139|Drug|Avelumab|Administered intravenously
15912041|NCT03558126|Device|silicone tube|
15912042|NCT03558113|Diagnostic Test|light induced fluorescence intraoral camera|intraoral oral light induced fluorescence diagnostic camera
15912043|NCT03558100|Behavioral|Obstacle crossing intervention for adults with obesity|The obstacle crossing intervention will be done for reducing falls risks in obesity. The intervention will provide gait practice to individuals with obesity who are eligible for and prior to weight loss surgery.
15912158|NCT03557307|Biological|Benralizumab|Benralizumab subcutaneous injection
15941766|NCT03328494|Drug|Paclitaxel|IV infusion
15912044|NCT03558087|Drug|Nivolumab|Nivolumab 360mg will be administered on Day 1 of each 21 day cycle for four 21-day cycles. Based on response and a balanced patient-physician discussion, subjects may receive nivolumab 240 mg for 8 cycles (cycle = 14 days).
15912045|NCT03558087|Drug|Gemcitabine|Gemcitabine 1000mg/m^2 will be administered on Days 1 and 8 for four 21-day cycles.
15912046|NCT03558087|Drug|Cisplatin|Cisplatin 70mg^m2 will be administered on Day 1 for four 21-day cycles.
15912047|NCT03558074|Drug|ALK4290|ALK4290 400 mg tablet twice a day
15912048|NCT03558061|Drug|ALK4290|ALK4290 400 mg tablet twice a day
15912049|NCT03558048|Diagnostic Test|Blood draw|Subjects will have their blood drawn during clinic visits over the course of the study period to measure their serum prostate specific antigen levels.
15912050|NCT03558035|Drug|Induction CT+ CRT group|Induction CT: Paclitaxel 175mg/m2 IV on d1 and d22, cisplatin 75mg/m2 IV on d1 and d22, 5-Fluorouracil 750mg/m2 IV continuously on d1-4 and d22-25, CRT: cisplatin 80mg/m2 IV on d1 of each 21 days cycle and 70 Gy radiotherapy
15912051|NCT03558035|Radiation|Concurrent CRT group|cisplatin 100mg/m2 IV on d1 of each 21 days cycle and 70 Gy radiotherapy
15912052|NCT03558022|Dietary Supplement|Salt Pills|7 days of a low sodium diet plus 4 salt pills (sodium chloride) taken 3 times daily with meals (approximately 7000 milligrams per day)
15912053|NCT03558022|Dietary Supplement|Placebo Pills|7 days of low sodium diet plus 4 placebo pills (microcrystalline cellulose) taken 3 times daily with meals
15912054|NCT03557996|Drug|Silver Diamine Fluoride|SDF will be applied with a brush
15912055|NCT03557996|Drug|Sodium Fluoride Varnish|NaF will be applied with a brush
15912056|NCT03557983|Drug|Fenofibrate|Fenofibrate is dissolved in Saline and topically spread three times per day at the irradiated areas, with a concentration of 400 μg/mL for week.
15912057|NCT03557983|Drug|Saline|Saline is topically spread three times per day at the irradiated areas for one week.
15912058|NCT03557970|Drug|Edicotinib|Given PO
15912059|NCT03557970|Other|Pharmacokinetic Study|Correlative studies
15912060|NCT03557957|Other|Targeted correction of plasma sodium levels|Targeted correction of hyponatremia
15912061|NCT03557957|Other|Standard care|Standard care of hyponatremia
15912062|NCT03557944|Other|Medication reduction|Systematic approach to reduction in polypharmacy.
15912063|NCT03557931|Drug|ASP4345|oral administration
15912064|NCT03557931|Drug|placebo|oral administration
15912065|NCT03557931|Drug|risperidone|oral or depot administration
15912066|NCT03557931|Drug|quetiapine|oral administration
15912067|NCT03557931|Drug|olanzapine|Oral or depot administration
15912068|NCT03557931|Drug|ziprasidone|Oral or depot administration
15912069|NCT03557931|Drug|aripiprazole|Oral or depot administration
15912070|NCT03557931|Drug|brexpiprazole|Oral administration
15912071|NCT03557931|Drug|paliperidone|Oral or depot administration
15912072|NCT03557931|Drug|lurasidone|Oral administration
15912073|NCT03557918|Drug|Tremelimumab|"Tremelimumab 750 mg IV on Day 1 of each 28 day cycle; up to 7 cycles.
~Subjects that complete all initial 7 cycles but later progress during follow up may receive an additional 7 cycles of tremelimumab providing they meet eligibility criteria."
15912074|NCT03557905|Device|RM|Patients will receive recruitment maneuver (RM) followed by decremental PEEP titration 1min. after establishment of mechanical ventilation and after documented lung re-collapse.
15912075|NCT03557905|Device|PEEP|The patient will be ventilated with volume control mode with tidal volume 6 ml/kg, PEEP 3 cmH2O, an inspiratory expiratory ratio of 1:1.5, respiratory rate 20-25 breaths per minute depending on the patient's age and FiO2 of 0.5.
15912076|NCT03557892|Device|CGM+CSII|Animas Vibe Platinum insulin pump and Dexcom G4 CGM
15912077|NCT03557892|Device|MDI with degludec|Multiple injection therapy with any short-acting analogue as bolus insulin and degludec as basal insulin
15912078|NCT03557879|Genetic|Exome sequencing|DNA extracted from samples will undergo exome sequencing, i.e. sequencing of the coding regions of all known human genes (about 22,000)
15912079|NCT03557866|Diagnostic Test|running|individuals will be asked to run for 5 km in self selected speed
15912080|NCT03557853|Drug|Golimumab Injection|Simponi (golimumab) in fixed dose of 50 mg sc per month according to local label and local clinical practice.
15912081|NCT03557840|Drug|temocillin|Drug dosing and blood sampling as per the protocol
15912082|NCT03557827|Drug|Photodynamic Therapy with indocyanine green and diode laser|mechanical debridement by periodontal curets plus Indocyanine green solution activated by diode laser. The diode laser is classified as a Class I medical device according to the Directive 93/42/EEC
15912083|NCT03557827|Procedure|Mechanical debridement alone|Mechanical debridement by periodontal curets alone
15912084|NCT03557814|Device|LED appliance during mechanical debridement|Mechanical debridement by periodontal curets LED appliance is classified as a Class IIa medical device according to the Directive 93/42/EEC
15912085|NCT03557814|Device|LED appliance after mechanical debridement|Mechanical debridement by periodontal curets LED appliance is classified as a Class IIa medical device according to the Directive 93/42/EEC
15912086|NCT03557814|Device|Mechanical debridement alone|Mechanical debridement by periodontal curets alone
15912087|NCT03557801|Behavioral|Mammography with Community Health Worker (individual)|Immediately following consent and completion of the baseline assessment, alone with the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary.
15912088|NCT03557801|Behavioral|Mammography with Community Health Worker (group)|Immediately following consent and completion of the baseline assessment, women in the intervention arm will participate in a 20-30 minute group educational session from the community health worker. Well woman screening will follow the educational session. The community health worker will be available to assist with questions and language interpretation as necessary. After standard delivery of screening results, the community health worker will contact these participants to answer any questions about their screening results and to assist with scheduling any additional tests necessary.
15912264|NCT03556358|Drug|Paclitaxel|175 mg/m^2, 60 min IV infusion, every 3 weeks (Cycles 5-8)
15912089|NCT03557801|Other|Standard of Care Mammography|Immediately following consent and completion of the baseline assessment, women in the control arm will receive standard of care well woman screening. The control arm will receive screening results per standard protocol.
15912090|NCT03557788|Drug|Rifaximin Oral Tablet|PO 550mg TDS for 2 weeks
15912091|NCT03557775|Device|Inspiratory Muscle Strength Training (IMST)|IMST will be conducted using an inspiratory pressure threshold trainer (Philips Respironics® Threshold IMT or POWERbreathe® Medic Plus), which consists of a mouthpiece with a spring-loaded valve. The valve blocks the airflow until the threshold pressure is achieved by breathing in forcefully into the device. This allows airflow as long as the sufficient pressure is maintained.
15912092|NCT03557775|Device|Expiratory Muscle Strength Training (EMST)|EMST will be conducted using an expiratory pressure threshold trainer (EMST150®), which consists of a mouthpiece with a spring-loaded valve. The valve blocks the airflow until the threshold pressure is achieved by breathing out forcefully into the device. This allows airflow as long as the sufficient pressure is maintained.
15912093|NCT03557775|Behavioral|Voice Exercises|Voice exercises will consist of the Vocal Function Exercises (VFE) protocol, developed by Stemple (2005). It contains 4 steps: (a) sustain the vowel /i/ on the musical note F for as long as possible. Repeat as judged by the SLP. (b) Glide from the lowest note to the highest note. Repeat as judged by the SLP. (c) Glide from the highest note to the lowest note. Repeat as judged by the SLP. (d) Sustain the notes C-D-E-F-G for as long as possible. Each note will be repeated until the participant finds the right placement (forward-focused voice), as judged by the SLP. Humming will be used to facilitate placement.
15912094|NCT03557762|Behavioral|Mindfulness|A psychological behavioral intervention that trains participants in mindfulness techniques, which involves achieving a moment-to-moment non-judgmental awareness of their internal psychosocial-emotional state, through meditation and gentle mindful movements.
15912095|NCT03557749|Diagnostic Test|Blood Sample|60 ml heparinized blood 10 ml serum
15912096|NCT03557749|Diagnostic Test|Stool Sample|pea-sized amount
15912097|NCT03557749|Diagnostic Test|Urine Sample|10 ml
15912098|NCT03557749|Diagnostic Test|Bronchoalveolar Lavage (BAL) fluid|10 ml
15912099|NCT03557749|Diagnostic Test|Gastrointestinal biopsy x 2-4|rectosigmoid site preferred
15912100|NCT03557749|Diagnostic Test|Skin biopsy|2-4 mm punch
15912101|NCT03557749|Diagnostic Test|Skin, mouth, and/or ocular swab|Involved skin, mouth, and/or ocular swab for microbiota studies
15912102|NCT03557749|Diagnostic Test|Apheresis Product|Up to 10 ml of apheresis product
15912103|NCT03557749|Diagnostic Test|Final cellular product|A second washing from the infusion bag after product and initial bag wash has infused, or up to 10 ml of final cellular product
15912104|NCT03557736|Behavioral|Training mode|type of exercise training completed for 12 weeks
15912105|NCT03557723|Other|Art activities program|"The intervention will be the MMFA art activities program Les Beaux Jeudis. Three activities will be examined:
~Cultural mediation workshop
~Supervised visit and tour of the museum
~Cultural mediation workshop combined with supervised visit and tour of the museum
~The duration of the MMFA art activities program Les Beaux Jeudis will be 3 months. Each participatory-based art activity is a weekly activity."
15912106|NCT03557710|Behavioral|Devaluing energy-dense foods for cancer-control|A 3-arm randomized controlled trial experiment study over 12 months. At baseline, participants will complete behavioral, neural, and self-report measures related to food, specifically measures of food valuation and of the proximal neural systems hypothesized to be linked to each of the 2 experimental arms. We will also measure food intake and body composition at baseline. Then participants will be randomized to one of 3 arms (2 experimental + 1 active control) for 8 30-min sessions to occur twice weekly at the University of Oregon for 30 days. At endpoint (~1 month following baseline), all behavioral, neural, and self-report measures will be reassessed, as will eating, habit, and body composition measures. Follow-ups at 3, 6, and 12 months will assess all measures except neuroimaging.
15912107|NCT03557697|Behavioral|Standard of Care|At the end of the study the control group will be provided with the opportunity to receive counseling videos delivered via SMS
15912108|NCT03557697|Behavioral|SMS Intervention|Participants in the intervention group will receive SMS based video counseling which include both educational and SCT=-based behavioral content.
15912109|NCT03557684|Dietary Supplement|leucine|amino acid leucine in powder
15912110|NCT03557684|Other|PO placebo|maltodextrin
15912111|NCT03557684|Biological|lipopolysaccharide (LPS)|purified bacterial wall component as an inflammatory challenge
15912112|NCT03557684|Other|IV placebo|0.9% saline
15912113|NCT03557671|Dietary Supplement|rice formula|new rice based thickened formula
15912114|NCT03557671|Dietary Supplement|placebo|formula previously tolerated by the subject - only for the 1st part of the study
15912115|NCT03557658|Drug|Bexagliflozin|Single oral dose of bexagliflozin tablet, 20 mg
15912116|NCT03557645|Device|Baseline Mechanical Ventilation|The subjects will be kept in Volume Control Continuous Mandatory Ventilation (VC-CMV).
15912117|NCT03557645|Device|VHI With Inspiratory Pause|Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV) with an inspiratory pause.
15912118|NCT03557645|Device|VHI Without Inspiratory Pause|Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV) without an inspiratory pause.
15912119|NCT03557632|Behavioral|Virtual Reality Cue Exposure Therapy|As above.
15912120|NCT03557632|Behavioral|Relapse Prevention Drug Education|As above.
15912123|NCT03557606|Procedure|Alar treatment with BMC using anterior approach|Patients with CCJ instability will undergo a bone marrow aspiration of approximately 30-60 cc. Platelet rich plasma (PRP) and platelet lysate (PL) will be derived from the bone marrow aspirate and later mixed with the bone marrow cell layer. While under TIVA anesthesia, the injectate is then injected under fluoroscopy into the area in need of treatment using an anterior approach through the posterior oropharynx with direct visualization of the injection site via endoscopy. The alar, transverse, and accessory ligaments are the target areas to be treated with the bone marrow concentrate.
15912124|NCT03557593|Other|Educational|Multi component educational intervention in long-term care
15912265|NCT03556358|Drug|Epirubicin|75 mg/m^2, IV bolus infusion, every 3 weeks (Cycles 1-4)
15912125|NCT03557580|Drug|IS-5-MN R|single orally dose under fed conditions on day 1 of treatment period 1 for group 1, on day 1 of treatment period 2 for group 2, on day 1 of treatment period 3 for group 3.
15912126|NCT03557580|Drug|IS-5-MN T1|single orally dose under fed conditions on day 1 of treatment period 2 for group 1, on day 1 of treatment period 3 for group 2, on day 1 of treatment period 1 for group 3.
15912127|NCT03557580|Drug|IS-5-MN T2|single orally dose under fed conditions on day 1 of treatment period 3 for group 1, on day 1 of treatment period 1 for group 2, on day 1 of treatment period 2 for group 3.
15912128|NCT03557567|Diagnostic Test|NGS molecular screening|
15912129|NCT03557554|Other|Massage|A 20 minute massage protocol will be administered in a chair by a licensed massage therapist no more than 24 hours prior to each paclitaxel infusion.
15912130|NCT03557541|Dietary Supplement|Sardine|They received 200gr of canned sardine in olive oil per week (+a common T2D-preventive diet)
15912131|NCT03557541|Dietary Supplement|Control|They received a common T2D-preventive diet
15912132|NCT03557528|Procedure|Laparoscopic colorectal resection|Gruop 1: laparoscopic rectosigmoid resection with standard ligation of mesenteric artery at its origin Group 2: Laparoscopic rectosigmoid resection with low ligation of inferior mesenteric artery and its skeletonization with en bloc removal of all lymph nodes
15912133|NCT03557515|Behavioral|Stress Management and CBT|"Stress Management will focus on:
~Mind-Body Connection
~Coping Skills
~Communication
~Social Support
~Cognitive Behavioral Therapy will focus on:
~Intro to CBT-Tracking Automatic Thoughts
~Identifying Distorted Thoughts
~Challenging Distorted Thoughts
~Core Beliefs/Relapse Prevention"
15912134|NCT03557515|Behavioral|Stress Management and Metta-Meditation|"Stress Management will focus on:
~Mind-Body Connection
~Coping Skills
~Communication
~Social Support
~Metta-Meditation will focus on:
~Intro to Meditation vis Mindfulness of the Breath and Body-Noticing Critical Self Talk
~Intro to Brief Loving-Kindness Meditation and Self-Care
~Continuing with Additional Metta-Based Exercises to Cultivate Compassion for Oneself and Others and Mitigating Self-Criticism
~Review/Plan for Future"
15912135|NCT03557502|Other|Heat Therapy Group|30 sessions of immersion in 40.5 degree celsius water for 45 minutes per session
15912136|NCT03557502|Other|Aerobic Exercise Group|30 sessions of aerobic exercise training for 45 minutes at 60% of VO2peak
15912137|NCT03557489|Device|Mepilex Border Sacrum|Patients use gel pad(in usual) in addition to use Mepilex Border Sacrum foam pad during surgery.
15912138|NCT03557476|Dietary Supplement|Octacosanol|One capsules (20-mg) of 100% refined octacosanol powder from sugar cane (Swanson, Fargo ND, USA) was consumed twice a day
15912139|NCT03557476|Dietary Supplement|Placebo|A placebo pill was taken twice a day in a double-blinded method at the same frequency and time as the octacosanol supplement
15912140|NCT03557463|Dietary Supplement|Dairy protein|A controlled, randomized, double blind pilot study was conducted using two different protein sources as nutritional supplementation to enhance vaccine response.
15912141|NCT03557450|Device|PET/CT Scan|PET/CT scanning with sodium fluoride
15912142|NCT03557437|Drug|Esomeprazole|Proton pump inhibitor
15912143|NCT03557437|Drug|Amoxicillin, Metronidazole|Antibiotics for H. pylori eradication
15912144|NCT03557437|Drug|Bismuth Potassium Citrate|Gastric mucosal protective drug with anti-H. pylori effect
15912145|NCT03557424|Drug|Polyglucosamine Glucomannan normal dose (Verum)|Patients received Verum three times a day for 65 days. The patients had to dissolve the powder included in one sachet in 250 ml water and drink the solution 15 minutes before each meal. It was recorded whether the patients changed their Lifestyle (their dietary habits and doing sports) during the study.
15912146|NCT03557424|Drug|Polyglucosamine Glucomannan high dose (Verum)|Patients received Verum 2 three times a day for 65 days. The patients had to dissolve the powder included in one sachet in 250 ml water and drink the solution 15 minutes before each meal. It was recorded whether the patients changed their Lifestyle (their dietary habits and doing sports) during the study.
15912147|NCT03557424|Drug|Placebo Comparator: Placebo|Patients received Placebo three times a day for 65 days. The patients had to dissolve the powder included in one sachet in 250 ml water and drink the solution 15 minutes before each meal. It was recorded whether the patients changed their Lifestyle (their dietary habits and doing sports) during the study.
15912148|NCT03557411|Drug|SHR-1210|SHR-1210 （an Anti-PD-1 Inhibitor） Simultaneously Combined with Hypofraction Radiotherapy
15912149|NCT03557398|Device|Hydeal-D vaginal pessaries|One vaginal application of Hydeal-D vaginal pessaries every 3 days to a total of 12 consecutive weeks.
15912154|NCT03557372|Radiation|Mathematical Model-Adapted Radiation Fractionation Schedule|"Re-irradiation with 35 Gy delivered over 2 weeks, based upon reference dosing of 35 Gy in 10 Fractions over 2 weeks
~Radiation therapy is delivered on Monday-Friday during standard clinic hours in our department. Each treatment may take 20-40 minutes.
~Treatment will be once daily for the first 7 days of treatment and then three-times daily for the last three days of treatment."
15912155|NCT03557359|Drug|Nivolumab|Nivolumab (Opdivo®) is a human monoclonal antibody (HuMAb; immunoglobulin G4 (IgG4)- S228P) that targets the PD-1 cluster of differentiation 279 (CD279) cell surface membrane receptor.
15912156|NCT03557346|Device|the WAM-5500 binocular autorefractor/keratometer (Grand Seiko Co. Ltd., Hiroshima, Japan)|: Subjects underwent a basic ophthalmic examination and the accommodative response to refractive stimuli was measured. Refractive stimuli were given at 0.25 diopters (D) (4 m distance), 2D (50 cm), 3D (33 cm), and 4D (25 cm) and stimulation was applied with the eyes in binocular, monocular (dominant eye, non-dominant eye, ipsilateral, and contralateral), and pinhole conditions. In addition, changes in the astigmatic value and direction of the astigmatism axis under binocular stimulus were evaluated.
15912157|NCT03557333|Combination Product|INP104|No more than 2 doses within 24 hours, 3 doses within 7 days. 1.45 mg in a divided dose, one actuation per nostril.
15912159|NCT03557294|Drug|1.0mg Varenicline b.i.d.|Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype.
15912160|NCT03557294|Drug|0.5mg Varenicline b.i.d.|Varenicline is classified as a selective nicotine receptor partial agonist (SNRPA) that works both to stimulate the nicotine receptor and block smoking reward at the α4β2 nicotinic receptor subtype.
15912161|NCT03557294|Drug|0.0mg placebo Varenicline b.i.d.|Product that looks like active varenicline, but contains no active ingredient
15912162|NCT03557281|Drug|GSK3036656|GSK3036656 will be available as an oral capsule with dosing strengths of 1 milligrams or 5 milligrams or 25 milligrams.
15912163|NCT03557281|Drug|RIFAFOUR e-275|RIFAFOUR will be available as an oral tablet with a standard dose of 150/75/400/275 milligrams of rifampicin, isoniazid, pyrazinamide and ethambutol per tablet respectively.
15912164|NCT03557255|Drug|Levosimendan|Preoperative 24 hours infusion of levosimendan for chronic heart failure patients prior to major abdominal cancer surgeries.
15912165|NCT03557255|Drug|Saline|Preoperative 24 hours infusion of normal saline for chronic heart failure patients prior to major abdominal cancer surgeries.
15912166|NCT03557242|Device|TAVR|Transcatheter Aortic Valve Replacement
15912167|NCT03557242|Other|Warfarin plus Aspirin|Subjects randomized to this arm will receive Warfarin plus aspirin for 30- 45 days post TAVR
15912168|NCT03557242|Other|Aspirin Only|Subjects randomized to this arm will receive aspirin only post TAVR
15912169|NCT03557229|Drug|Melatonin 5 mg|Oral: 50 mg once daily for 5 days
15912170|NCT03557229|Drug|Vitamin C 1 GM Oral Tablet|Oral: 1 GM every 6 hours for 5 days
15912171|NCT03557229|Drug|Vitamin E 400 UNT|Oral: 400 UNT every 8 hours for 5 days
15912172|NCT03557229|Drug|N-acetylcysteine|Oral: 1200 mg every 12 hours for 5 days
15912173|NCT03557216|Diagnostic Test|Colonoscopy|Anal introduction of a long, flexible, tubular instrument about 1/2-inch in diameter that transmits an image of the lining of the colon so the doctor can examine it for any abnormalities
15912174|NCT03557216|Diagnostic Test|Fecal immunochemical and occult blood test|A test for fecal occult blood looks for blood in your feces. It can be a sign of a problem in the digestive system, such as a polyp or cancer in the colon.
15912175|NCT03557216|Diagnostic Test|Fecal calprotectin test|Calprotectin is a protein released by neutrophils. When there is inflammation in the colon, neutrophils move to the area and release calprotectin, resulting in an increased level in the stool. This test measures the level of calprotectin in stool as a way to detect inflammation and lesions in the colon.
15912176|NCT03557151|Other|Usual Care|Usual Care participants will receive the same excellent multidisciplinary Care they would receive at the same center were they not enrolled in the trial. In clinic visits scheduled at approximately 3-month intervals, they will see subspecialty board certified or eligible pediatric endocrinologists, supplemented as needed with involvement of certified diabetes educators, dietitians, social workers or psychologists. HbA1c target is < 7.5% with no severe hypoglycemia and acceptable quality of life. About half are expected to be on insulin pumps and carbohydrate counting, while the great majority of others are following basal-bolus multiple daily injection regimens, also based on carbohydrate counting. A rising proportion of patients use continuous glucose monitors and this trend is likely to accelerate during the study.
15912177|NCT03557151|Behavioral|Transdisciplinary Care-In Person & Telehealth|TC participants will receive all elements of the Usual Care intervention but they will do so in the context of face to face or telehealth delivery of TC follow-up visits with simultaneous involvement of an advanced practice nurse, dietitian and psychologist at each visit.
15912178|NCT03557138|Behavioral|alpha-Methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside|positron emission tomography and magnetic resonance imaging (PET/MRI) of kidneys of diabetic patients using alpha-Methyl-4-deoxy-4-[(18)F]fluoro-D-glucopyranoside (Me4FDG)
15912179|NCT03557125|Other|QL Block|If the subject has been randomized to the block group, a subcutaneous lidocaine skin wheel placed will be placed followed by a quadratus lumborum regional block with 40 ml, 0.25% ropivacaine deposited deep to the transversus abdominus apnoneurosis and superficial to the fascia transversalis with direct ultrasound guidance. Local anesthetic will be injected in 5 ml aliquots with aspiration for blood performed before and after the injection of each aliquot. Local anesthetic injection will also be observed with real time ultrasound guidance.
15912180|NCT03557125|Other|Saline Skin Wheel|"The skin will be cleaned with chlorhexidine. If the subject has been randomized to the no block group, a subcutaneous saline skin wheel will be placed and the procedure would end at this point."
15912181|NCT03557112|Drug|Nimotuzumab|TPF Regimen Induction Chemotherapy combined with nimotuzumab concurrent radiotherapy concurrent chemoradiotherapy
15912182|NCT03557112|Drug|Cisplatin|TPF Regimen Induction Chemotherapy combined with cisplatin concurrent radiotherapy concurrent chemoradiotherapy
15912183|NCT03557099|Drug|Hetrombopag Olamine|once daily
15912184|NCT03557086|Behavioral|Advance Care Planning Video Decision Support Tool|Advance care planning video intervention as previously described
15912185|NCT03557086|Other|Verbal Narrative|Verbal description of end of life care options
15912186|NCT03557073|Behavioral|Postoperative phone call|The intervention is a phone call on the day following surgery.
15912187|NCT03557060|Drug|Nucala|NUCALA injections will be administered to eligible subjects with diagnosis of EGPA. Dose unit, daily dose frequency, date of administration will be at the investigator discretion.
15912188|NCT03557034|Device|Kardia Monitoring|Kardia Mobile is an FDA approved device that allows one lead ECG recording for 30 seconds using the patient's smart phone. The device has a built-in algorithm that detects AF. KardiaPro is a secure platform that allows the physician to access the patient's recording at any time. The platform can also be programmed to send a notification to the healthcare provider if AF is detected by the software.
15912189|NCT03557021|Diagnostic Test|HIV Drug resistance testing|HIV Drug resistance testing by HIV pro DNA sanger sequencing
15912190|NCT03557008|Biological|Rabies Vaccine|A single 1.0 milliliter (mL) dose of Imovax® will be given to participants on Day 0 and Day 28 of the study.
15912191|NCT03557008|Drug|Metronidazole|The antibiotic regimen will be given for five days beginning 3 days prior to vaccination, on the vaccination day, and one day after vaccination for a total for 5. The regimen will include 500 milligrams (mg) of Flagyl taken by mouth three times a day.
15912266|NCT03556358|Drug|Cyclophosphamide|600 mg/m^2, 30 min IV infusion, every 3 weeks (Cycles 1-4)
15912192|NCT03557008|Drug|Vancomycin|The antibiotic regimen will be given for five days beginning 3 days prior to vaccination, on the vaccination day, and one day after vaccination for a total for 5. The regimen will include 125 mg of Vancocin taken by mouth four times a day.
15912193|NCT03557008|Drug|Neomycin Sulfate|The antibiotic regimen will be given for five days beginning 3 days prior to vaccination, on the vaccination day, and one day after vaccination for a total for 5. The regimen will include 500 milligrams (mg) of Neomycin sulfate taken by mouth three times a day.
15912194|NCT03556995|Other|bariatric surgery patients|
15912195|NCT03556982|Biological|CART-123 cells|CD123-Targeted CAR-T cells are infused to patient received FC chemotherapy
15912196|NCT03556969|Other|Observation|no intervention
15912197|NCT03556956|Drug|Masitinib|Tyrosine kinase inhibitor
15912198|NCT03556930|Device|AlignRT system (VisionRT LTD, UK)|Pediatric patient will watch age-proper movie during radiation treatment. The motion of pediatric patient will continually be monitored by an AlignRT system (VisionRT LTD, UK). Both movie and radiation beam will be paused if the motion of pediatric patient is beyond positioning accuracy threshold. Movie and beam will be resumed if pediatric patient is positioning with in tolerance.
15912199|NCT03556917|Combination Product|iontophoresis + caffeine|we will use cafeislaine c (caffeine) +galvanic current
15912202|NCT03556891|Device|eCoin Tibial Nerve Stimulation|Subcutaneous stimulation of the tibial nerve using the eCoin device.
15912203|NCT03556878|Behavioral|Fitted Transdiagnostic Sleep and Circadian intervention|Fitted TranS-C is an adapted version is designed to improve the fit with community needs and resources.
15912204|NCT03556865|Other|A self administered questionnaire|"The questionnaire is in English language, it contains binary questions related to KAP on different preventive measures in pediatric dentistry and consists of 38 items divided into 4 sections as follows:
~I) Socio-demographic data: (7 items). It includes gender, total years in practice, nature of primary practice, school of graduation, scientific degree and specialty II) Assessment of Knowledge towards preventive measures in pediatric dentistry. (16 items) III) Assessment of Attitude towards preventive measures in pediatric dentistry. (10 items) IV) Assessment of Practice towards preventive measures in pediatric dentistry. (5items) One score is given for each response to items."
15912205|NCT03556852|Drug|Carbetocin|1 ampoule of Carbetocin (100 μg/ml) added to 10 cc saline and given IV after the delivery of the baby
15912206|NCT03556852|Drug|Misoprostol|2 rectal misoprostol tablets (800 μg) after the delivery of the baby.
15912207|NCT03556839|Drug|Atezolizumab|Intravenous Infusion
15912208|NCT03556839|Drug|Bevacizumab|Intravenous Infusion
15912209|NCT03556839|Drug|Cisplatin/Carboplatin|Intravenous Infusion
15912210|NCT03556839|Drug|Paclitaxel|Intravenous Infusion
15912211|NCT03556826|Behavioral|Social Value Learning Training|For each child, two faces will be assigned the high-value (HV) status and the other two the low-value (LV) status. Value status will be randomized between the faces and children and all four faces will have the same probability of being assigned HV or LV across all participants. A gaze fixation on a HV face will always activate a dynamic display and the face will smile brightly. A gaze fixation on a LV face will always result in no change to its display.
15912212|NCT03556813|Other|survey|non-inferiority study, randomized, blind, excluding health product, with no risk or constraint, in which all the acts are performed in the usual way and do not modify the patient's management.
15912213|NCT03556800|Drug|Estrogel|"Each subject will receive the following IMPs in accordance with the randomisation code:
~Test IMP: a single-dose of 0.5g, 0.75g and 1.25g VML-0203 cream
~Reference IMP: a single-dose of 1.25g EstroGel"
15912214|NCT03556787|Device|BPI 1000013 (Dr Scholls Insole)|Full length foam insole
15912215|NCT03556774|Behavioral|'WeChat WeQuit' smoking cessation training program|Providing 'WeChat WeQuit' smoking cessation training program for healthcare service providers (HSPs) and assessing their utilization of behavioral and pharmacotherapy interventions for cigarette smoking cessation.
15912216|NCT03556761|Drug|Oral furosemide|Furosemide (Lasix), 20 milligram, PO, PO, daily
15912217|NCT03556761|Drug|Placebo Oral Tablet|Placebo, PO, daily
15912218|NCT03556748|Other|whole-body electromyostimulation|WB-EMS training is performed 2x/week for a total of 12 weeks; Stimulation protocol: Frequency of 85 Hz, pulse duration of 0.35 ms, stimulation period of 6 sec, resting period of 4 sec; supervised by certified training instructors/physiotherapists participants perform simple exercises during the stimulation period following a video tutorial
15912219|NCT03556735|Device|Treatment with PEMF equipment|Treatment with PEMF in 8 weeks
15912220|NCT03556722|Device|Repetitive Transcranial Magnetic Stimulation.|High frequency rTMS on left dorsolateral prefrontal cortex.
15912221|NCT03556722|Device|Sham rTMS|Sham rTMS without active magnetic coil on left dorsolateral prefrontal cortex.
15912222|NCT03556709|Device|Treadmill Ankle Robot Training|This intervention employs the use of an adaptive ankle robot control system, during treadmill walking, over a 6-week intervention period.
15912223|NCT03556696|Device|ANI-REMI-loop|experimental medical device using expert rules and continuous reading of heart rate, blood pressure and Analgesia Nociception Index for automatic remifentanil administration
15912224|NCT03556696|Device|remifentanil pK/pD target administration device|standard practice, remifentanil administration using Minto's pK/pD model
15912225|NCT03556696|Drug|Remifentanil|Remifentanil Ce target can range from 0 to 10 ng.ml-1. Remifentanil target is adapted in order to maintain Analgesia Nociception Index (MDMS, Loos, France) in the [50-70] range.
15912226|NCT03556696|Drug|Propofol|propofol is used for induction and maintenance of general anesthesia using Schnider pK/pD model. Propofol Ce target is adapted in order to maintain BiSpectral Index in [40-60] range
15912227|NCT03556696|Device|ANI monitor|"ANI (Analgesia Nociception Index) value is used in the std_practice arm for guidance of the remifentanil Ce target"
15912228|NCT03556683|Device|Hypertonic Saline|4 mL of 7% hypertonic saline
15912267|NCT03556345|Drug|RC48-ADC|2.5 mg/kg IV every 2 weeks
15912229|NCT03556670|Behavioral|Total Worker Health|The intervention combines organizational and individual level strategies. Participants will be given access to pedal stands, health and safety messaging, and other environmental modifications. Intervention activities that participants could be asked to complete include: computer based training, goal setting and behavioral self-monitoring, scripted team-based health and safety discussions, and team competitions with pedal stands. Supervisor participants could additionally be asked to complete additional computer based training, goal setting and behavioral self-monitoring of supportive behaviors, and inter-supervisor observations. The intervention is six-months in duration.
15912230|NCT03556670|Other|Control|Usual practice control
15912231|NCT03556657|Other|Music Therapy|Patient receives 6 sessions of music therapy with a board-certified music therapist. Patient will learn various music interventions for pain management that he/she will utilize at home.
15912232|NCT03556644|Radiation|CTCA imaging|All the studied patients will have CTCA before percutaneous coronary intervention and 3 vessel NIRS-IVUS imaging during percutaneous coronary intervention
15912233|NCT03556631|Drug|live combined Bifidobacterium and Lactobacillus Tablets|take the live combined Bifidobacterium and Lactobacillus Tablets 4# or placebo twice a day
15912234|NCT03556618|Behavioral|Whole Person Care (WPC) Reentry Program|Social network intervention to provide care coordination and social support during youth reentry.
15912235|NCT03556605|Other|OneTouch Reveal® Mobile APP system|Improved glycemic control in people with diabetes using the OneTouch Verio® Flex Blood Glucose Monitor and the OneTouch Reveal® Mobile APP system (intervention group) compared to subjects continuing to use their own Blood Glucose Monitor without connection to mobile diabetes apps (control group).
15912236|NCT03556605|Other|Current Blood Glucose Monitor|Subjects continue to use current Blood Glucose Monitor without connection to mobile diabetes apps.
15912237|NCT03556592|Drug|Tralokinumab|Human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. Presented as a liquid formulation for subcutaneous injection.
15912238|NCT03556592|Drug|Caffeine|1x 100 mg tablet
15912239|NCT03556592|Drug|Warfarin|2x 5 mg tablets
15912240|NCT03556592|Drug|Omeprazole|1x 20 mg capsule
15912241|NCT03556592|Drug|Metoprolol|1x 100 mg tablet
15912242|NCT03556592|Drug|Midazolam Hydrochloride|1 mL of 2 mg/mL oral solution/syrup
15912243|NCT03556579|Device|senofilcon A with new UV blocker|Test Lens
15912244|NCT03556579|Device|senofilcon A|Control Lens
15912245|NCT03556566|Biological|Tableted vaccine (V3-OVA) containing ovarian cancer antigens|One pill of V3-OVA per day for three months
15912246|NCT03556553|Device|Vertise Flow|Composite resin
15912247|NCT03556553|Device|LuxaFlow|Composite resin
15912248|NCT03556553|Device|Teco Adhesive|Adhesive system
15912249|NCT03556540|Other|physical exercise|Each participant will perform 30 minutes of aerobic physical activity, using cycle ergometer. The exercise will begin 30 minutes after the start of hemodialysis.
15912250|NCT03556501|Diagnostic Test|Endoscopy|Purpose of this study is to create a prospective registry of patients with pancreatic collections and their imaging studies
15912251|NCT03556488|Diagnostic Test|US air bronchogram score|"On ultrasonographic examination, lung consolidation is defined as a subpleural echo-poor region or one with tissue- like echotexture, depending on the extent of air loss and fluid predominance, which is clearly different from the normal pattern.
~The air bronchogram is characterized as: absent, static, dynamic, dynamic with areas of lung recruitment."
15912252|NCT03556462|Other|Sleep Health Education|Parents and children receive sleep health education
15912253|NCT03556449|Diagnostic Test|High resolution ultrasound|Using a high-frequency linear array transducer (18L6 HD)
15912254|NCT03556436|Drug|YH25448 240mg|period 1: A single oral dose of YH25448 240 mg an overnight fast period 2: A single oral dose of YH25448 240 mg after a high-fat breakfast
15912255|NCT03556410|Behavioral|sleep|Shortened sleep will be requested of all subjects. During this time normal physical activity will be monitored.
15912256|NCT03556410|Behavioral|exercise|Shortened sleep will be requested of all subjects. During this time normal physical activity will be monitored and 45 min of exercise will be required during the shortened sleep days .
15912257|NCT03556397|Procedure|Sentinel lymph node biopsy (SLNB)|Sentinel lymph node biopsy will be performed in the patients
15912258|NCT03556397|Procedure|Axillary dissection|Axillary dissection procedure will be performed in the patients
15912259|NCT03556384|Drug|Temozolomide|"Temozolomide 85 mg/m2 will be administered orally for 21 days followed by 7 days without treatment in 28 day cycles.
~Treatment will continue for 6 months (with option to continue if benefiting treatment) or until disease progression or unacceptable toxicity (whichever occurs first). All patients will have regular evaluations for assessment of safety parameters"
15912260|NCT03556371|Drug|N-Acetylcysteine|In each patient recruited, assignation to placebo or N-Acetylcysteine group treatment wil be performed, after he/she has signed the informed consent. In the first visit, the evaluation by the psychiatrist and with the nurse team (structured evaluation, which includes the CCQ-N-10, CSSA, general health evaluation, urine drug test and basal blood screening), will be carried out. The nurse team will supervise the drug intake and they will observe 2 hours late the ADRs and general health status of patient, who will be responsible for the intake of the following medication doses. Each patient will be asked to attend twice week to his/her treatment center, during four weeks and each patient visit the clinical team will record the primary and secondary outcome.
15912261|NCT03556371|Drug|Placebo oral capsule|In each patient recruited, assignation to placebo or N-Acetylcysteine group treatment wil be performed, after he/she has signed the informed consent. In the first visit, the evaluation by the psychiatrist and with the nurse team (structured evaluation, which includes the CCQ-N-10, CSSA, general health evaluation, urine drug test and basal blood screening), will be carried out. The nurse team will supervise the drug intake and they will observe 2 hours late the ADRs and general health status of patient, who will be responsible for the intake of the following medication doses. Each patient will be asked to attend twice week to his/her treatment center, during four weeks and each patient visit the clinical team will record the primary and secondary outcome.
15912262|NCT03556358|Biological|TX05 (trastuzumab)|8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)
15912263|NCT03556358|Biological|Herceptin®|8 mg/kg, 90 min IV infusion (Cycle 5), followed by 6 mg/kg, 60 min IV infusion (Cycles 6 - 8)
15912273|NCT03556319|Dietary Supplement|2-HOBA|2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate
15912274|NCT03556319|Dietary Supplement|Placebo|Placebo Comparator
15912275|NCT03556306|Procedure|Bariatric surgery|"The gastric bypass (simplified technique) was performed in an antecolic fashion, with a calibrated 2 cm gastro-jejunal anastomosis (linear stapler); biliary and alimentary limbs measured 70 and 150 cm respectively [17] . Mesenteric defects were closed and the omentum divided. The sleeve gastrectomy was performed at 5-6 cm from the pylorus over a 36 Fr. bougie, with oversuture of the staple line (2-0 polypropylene). Methylene blue test and the use of drains were done routinely."
15912276|NCT03556293|Behavioral|AKI Prevention Toolkit|AKI Prevention Toolkit. Intervention: All sites will receive the AKI Prevention Toolkit including 3 core interventions: 1. Standardized order sets; 2. IV and oral fluids; and 3. Reduced contrast volume. The interventions adhere to the KDIGO guidelines and add interventions developed and tested in our pilot intervention to implement AKI preventive strategies.
15912277|NCT03556293|Behavioral|Technical Assistance (TA)|Technical Assistance (TA). Intervention: TA will be offered to the 8 teams randomized to the TA condition and will receive the AKI Prevention Toolkit plus monthly technical calls independently. TA arms will include TA with and without automated surveillance reporting (ASR).
15912278|NCT03556293|Behavioral|Virtual Learning Collaborative (VLC)|Virtual Learning Collaborative (VLC). Intervention: The VLC will be offered to 8 teams and will receive the AKI Prevention Toolkit plus monthly virtual training calls with the other VLC sites. Each participating site will be supported to establish a multidisciplinary team charged with continuously improving AKI, which will include interventional cardiologists, cardiac catheterization lab manager and technicians, nursing representatives from the intensive care unit and/or holding areas, cardiology administration, nephrology, and representation from the quality improvement department (VA Clinical Application Coordinator [CAC] and Systems Redesign). VLC arms will include VLC with and without automated surveillance reporting (ASR).
15912279|NCT03556293|Behavioral|Automated Surveillance Reporting (ASR)|Automated Surveillance Reporting (ASR). Intervention: The ASR will be offered to 8 teams. In addition to either TA or VLC, ASR teams will receive automated monthly reports in the form of an dashboard focused on AKI outcome and preventative measures overtime. The ASR report will be customized to each team and each individual operator and linked to their national VA-CART registry.
15912280|NCT03556280|Device|GammaSense Stimulation System (Active Settings)|Proprietary auditory and visual sensory stimulation device.
15912281|NCT03556280|Device|GammaSense Stimulation System (Sham Settings)|Proprietary auditory and visual sensory stimulation device.
15912282|NCT03556267|Device|spinal needle|It is a spinal needle with 'QUINCKE' Bevel. It is inserted in the lumbar region at the inter-space L4-L5, L4-L3 ,or L3-L2 lumber spaces, while the patient is put in the sitting position then CSF sample is taken then 2.5 ml of a local anesthetic(0.5 ml of 25 ug fentanyl and 2 ml of 8 mg heavy bupivacaine) is given intrathecal then the needle is withdrawn.
15912283|NCT03556254|Drug|GGT|In the absence of 23S rRNA mutation, clarithromycin based sequential therapy will be given. In the presence of 23S rRAN mutation but the absence of gyrase A mutation, levofloxacin based sequential therapy will be given. In the presence of both 23S rRNA and gyrase A mutations or if genotyping fails, bismuth quadruple therapy will be given
15912284|NCT03556254|Drug|SGT|In the absence of clarithromycin resistance, clarithromycin based sequential therapy will be given. In the presence of clarithromycin resistance but the absence of levofloxacin resistance, levofloxacin based sequential therapy will be given. In the presence of both clarithromycin and levofloxacin resistance or if culture fails, bismuth quadruple therapy will be given.
15912285|NCT03556241|Device|Case management|Case management consists keeping patient's current pacemaker mode during surgery
15912286|NCT03556228|Drug|VMD-928 300 mg Tablets or 100 mg Capsules|Taken orally once daily
15912287|NCT03556215|Device|Eustachian tube dilatation device|Balloon Eustachian tuboplasty will be performed using a Eustachian tube dilatation device.
15912288|NCT03556215|Procedure|Myringotomy|Myringotomy will be performed using a standard procedure.
15912290|NCT03556189|Device|Case management|Case management consists adjusting AV delay of pacemaker to achieve best cardiac output measured by trans-thoracic echocardiogram
15912291|NCT03556176|Behavioral|Exercise|Three exercises sessions - 30 min (light: 45 - 50%, moderate: 65 -70% and vigorous: 85 - 90% Heart Rate Maximal).
15912292|NCT03556176|Behavioral|Quiet rest|Quiet rest during 30 min
15912293|NCT03556163|Procedure|Modified vertical internal mattress sutures + MWF surgery.|Modified vertical internal mattress sutures were given after modified Widman flap surgery.
15912294|NCT03556163|Procedure|Simple loop interrupted sutures + MWF surgery.|Simple loop interrupted sutures were given after modified Widman flap surgery.
15912295|NCT03556150|Other|Manual Therapy protocol|"This protocol consists of:
~Six minutes of joint's mobilisation (two minutes of each technique).
~Nine minutes of ischemic pressure . Three minutes per muscle in this order: temporal muscle, masseter muscle and lateral pterygoid. Choosing the two most painful trigger points.
~Three minutes of trigemino's nerve stretching."
15912296|NCT03556150|Other|Effleurage|"The protocol consists of:
~Five minutes in temporal muscle.
~Ten minutes superficial massage in the neck and cheek of the most painful joint.
~Five minutes of effleurage in the cheek, with the index finger inside the mouth and the thumb outside."
15912297|NCT03556137|Drug|[18F]FTC-146|Adult participants will be injected with 5-10 mCi of [18F]FTC-146 and undergo a PET/MRI scan.
15912298|NCT03556124|Device|Active - HD tDCS|Non-invasive neuromodulation using HD electrodes placed on the scalp to deliver a constant, low current at 2 mA.
15912299|NCT03556124|Device|Sham - HD tDCS|Sham neuromodulation using HD electrodes placed on the scalp to deliver a low current ramped up/down for 20 sec.
15912300|NCT03556124|Device|Active - Conventional tDCS|Non-invasive neuromodulation using standard 7 cm x 5 cm electrodes placed on the scalp to deliver a constant, low current at 2 mA.
15912301|NCT03556124|Device|Sham - Conventional tDCS|Sham neuromodulation using standard 7 cm x 5 cm electrodes electrodes placed on the scalp to deliver a low current ramped up/down for 20 sec.
15912302|NCT03556111|Procedure|Sticky bone augmentation|"Autogenous sticky bone augmentation for the first group
~Autogenous sticky bone preparation with xenograft usage
~After 5-month of bone grafting; esthetic implant placement"
15912303|NCT03556098|Drug|glucose-dependent insulinotropic peptide|Infusion of GIP
15912304|NCT03556098|Drug|Glucose-Dependent Insulin-Releasing Hormone[3-30]|Infusion of GIP antagonist GIP[3-30]
15912305|NCT03556098|Drug|Saline Solution|Infusion of Saline
15912306|NCT03556085|Device|Venous sinus stenting (Serenity River)|Patient is placed under general anesthesia. From femoral vein access, a standard guide-catheter is advanced in the internal jugular vein (on the side considered for stenting). The sigmoid then transverse sinus is catheterized with a microcatheter and guide-wire and an exchange guide-wire is placed in the superior sagittal sinus. The River stent delivery catheter is advanced over the exchange guide-wire in the sigmoid then transverse sinus up to the torcula. The River stent is deployed to cover the entire transverse sinus and the proximal half of the sigmoid sinus. The catheters are removed and hemostasis obtained by using a closure device or manual compression. The patient is kept overnight in the hospital for observation.
15912307|NCT03556072|Other|Routine ERCP|
15912308|NCT03556059|Other|Role of EOSS|The Edmonton Obesity Staging System (EOSS) is a more comprehensive measure of obesity-related diseases and predictor of mortality than body mass index (BMI) or waist circumference. Its application for the selection of obese patients for obesity surgery has been suggested. This study evaluates the role of the Edmonton Obesity Staging System (EOSS) in predicting postoperative outcome (next to the Clavien Dindo Classification) and 30-day mortality after metabolic surgery.
15912309|NCT03556046|Diagnostic Test|89Zr-Girentuximab|Single diagnostic injection on Day 0, followed by diagnostic scans on Days 3 and 7±1, as well as the whole body dosimetric imaging on Days 0, 1, 3 and 7±1
15912310|NCT03556033|Drug|Dapagliflozin|8 weeks treatment with dapagliflozin on top of insulin treatment
15912311|NCT03556033|Drug|Placebo oral capsule|8 weeks treatment with placebo capsules on top of insulin treatment
15912312|NCT03556020|Drug|Pemziviptadil (PB1046)|Pemziviptadil (PB1046), Once Weekly Subcutaneous Injection
15912313|NCT03556007|Drug|LY3471851|LY3471851 drug product is a sterile liquid for subcutaneous injection that will be diluted with sterile 0.9% sodium chloride solution for injection (USP) prior to administration.
15912314|NCT03556007|Drug|Placebo|The placebo dosing solution is 0.9% sodium chloride for injection (USP).
15912315|NCT03555994|Drug|MEDI0382|MEDI0382 administered subcutaneously
15912316|NCT03555994|Drug|Placebo|Placebo administered subcutaneously
15912317|NCT03555994|Drug|Liraglutide|Liraglutide administered subcutaneously
15912318|NCT03555981|Other|Early Kangaroo Mother Care|Continuous skin-to-skin contact between baby and mother/caregiver started within 24h of hospital admission
15912319|NCT03555981|Other|Standard care|Incubator or radiant heater care until stable, off oxygen and >24h of admission, at which point will start intermittent or continuous kangaroo mother care
15912320|NCT03555968|Drug|THC 0|THC dose = 0mg
15912321|NCT03555968|Drug|THC 5|THC dose = 5mg
15912322|NCT03555968|Drug|THC 10|THC dose = 10mg
15912323|NCT03555968|Other|BAC 0|Blood alcohol concentration = .000%
15912324|NCT03555968|Other|BAC .025|Blood alcohol concentration = .025%
15912325|NCT03555968|Other|BAC .049|Blood alcohol concentration = .049%
15912326|NCT03555955|Drug|CPX-351|CPX-351 is administered as an intravenous (IV) infusion over approximately 90 minutes.
15912327|NCT03555955|Drug|CPX-351|CPX-351 is administered as an intravenous (IV) infusion over approximately 90 minutes.
15912328|NCT03555942|Drug|Follicular phase corifollitropin alfa|GnRH antagonist protocol with corifollitropin alfa initiated in the follicular phase (day 2 or 3 of the menstrual cycle)
15912329|NCT03555942|Drug|Luteal phase corifollitropin alfa|GnRH antagonist protocol with corifollitropin alfa initiated in the luteal phase (5 days after an LH peak)
15912330|NCT03555929|Drug|Dexamethasone|80 minutes after achievement of axillary block, if the surgery is not ended, patients will be randomly assigned to one of the two groups : DEXA or Control. Injection will be done 90minutes after achievement of axillary block.
15912331|NCT03555929|Drug|Normal saline|80 minutes after achievement of axillary block, if the surgery is not ended, patients will be randomly assigned to one of the two groups : DEXA or Control. Injection will be done 90minutes after achievement of axillary block.
15912332|NCT03555916|Drug|BOTOX®, Allergan|50 U BTX-A (BOTOX®, Allergan) powder diluted in 2 mL saline solution (0.9% NaCl) administrated at visit 2 by intra oral injection
15912333|NCT03555916|Drug|Placebo|2 mL saline solution (0.9% NaCl) administrated at visit 2 by intra oral injection
15912334|NCT03555903|Other|Endometriosis cohort|"The investigator record data on risks factors, symptoms (pain), quality of life (using standardized quality of life questionnaires), infertility history, and management of the disease with a 5-years follow up.
~Different surgical procedures exist to treat DIE and are they are described in the database, to allow comparison."
15912335|NCT03555890|Drug|Levocetirizine IRT 5 mg|Levocetirizine IRT will be available as film-coated tablets. Subjects will receive a single dose of 5 mg levocetirizine IRT. Subjects will receive levocetirizine IRT with 150 mL water in both Part (1 and 2).
15912469|NCT03554928|Diagnostic Test|magnetic resonance imaging|Participants will receive a 60 minute magnetic resonance imaging assessment
15912336|NCT03555890|Drug|Levocetirizine ODT 5 mg|Levocetirizine ODT will be available as oral disintegrating tablet. Subjects will receive a single dose of 5 mg levocetirizine ODT. In Part 1, subjects will receive levocetirizine ODT with 150 mL water and in Part 2 subjects will receive levocetirizine ODT without water.
15912337|NCT03555877|Drug|Ribociclib|Ribociclib in addition to endocrine maintenance therapy. Endocrine therapy, at the discretion of the investigator, could have already been started up to 4 weeks before randomization but not later than with first dose of ribociclib.
15912338|NCT03555877|Drug|Anastrozole|1mg once daily as indicated in the SmPC
15912339|NCT03555877|Drug|Letrozole|2,5mg once daily as indicated in the SmPC
15912340|NCT03555877|Drug|Exemestane|25mg once daily as indicated in the SmPC
15912341|NCT03555877|Drug|Fulvestrant|(prefilled syringes with fulvestrant 250mg each), 500mg given once a month, with an additional 500mg dose given two weeks after the first dose as indicated in the SmPC
15912342|NCT03555864|Device|infrared transluminescent device|use of infra red for venous access for second intravenous access
15912343|NCT03555851|Drug|Cyclophosphamide|Pharmacogenomics of candidate genes and pharmacokinetic analyses of cyclophosphamide administered as part of a reduced intensity conditioning (RIC) regimen and as post-transplant GVHD prophylaxis will be examined.
15912344|NCT03555851|Other|Specimen collection|Buccal swabs will be obtained from donors for pharmacogenomics.
15912345|NCT03555838|Other|transcranial direct current stimulation|Transcranial direct current stimulation, a form of neuromodulation that uses a low direct current delivered via sponge electrodes on the head.
15912346|NCT03555838|Other|sham transcranial direct current stimulation|an inactive or placebo version of transcranial direct current stimulation placed on the head via sponge electrodes.
15912347|NCT03555825|Device|Hocoma ArmeoSpring|A spring-loaded upper extremity exoskeleton with 3 joints and 6 degrees of freedom. Participants use the more affected upper extremity to control and engage in therapeutic games.
15912348|NCT03555812|Other|Pelvic inclination measurement|Measurement of pelvic inclination per ultrasound
15912349|NCT03555799|Diagnostic Test|Inferior vena cava ultrasound|Abdominal ultrasound to identify IVC between hepatic veins and right atrium. Measurement of dimensions throughout respiratory cycle (before and after labor epidural)
15912350|NCT03555786|Other|minimum effective volume|"The determination of MEV90 and its 95% confidence interval (CI) will be based on a biased coin up-and-down sequential design"
15912351|NCT03555773|Procedure|Lipogems|After local surgical drainage of the perianal disease, micro-fragmented adipose tissue is injected circumferentially into the submucosa surrounding the internal fistula orifice and in the perianal tissue along the residual fistula tract.
15912352|NCT03555760|Behavioral|Observation of informed consent form readings of all patients who are scheduled for surgery|All patients who are scheduled for surgery will be observed for their initial reflex of inform consent form readings.
15912353|NCT03555747|Other|Canine distalization|GCF was sampled from the mesial (tension) and distal (pressure) sides of maxillary right and left canines immediately before appliance placement (baseline) and after force application (24 hours and 28 days)
15912354|NCT03555734|Other|Dietary pulses or legumes|Dietary pulses (dried beans, dried peas, chickpeas, lentils). If no data available specifically for dietary pulses than legumes will be assessed as the exposure (includes pulses, soybeans, peanuts, fresh peas, fresh beans).
15912355|NCT03555721|Other|Oral examination with incandescent light|Suspicious oral lesions will be identified by oral examination with incandescent light.
15912356|NCT03555721|Other|Oral examination with OralID|OralID uses a proven, optically based fluorescence technology that provides the clinician an aid in visualization of oral cancer, pre-cancer and other abnormal lesions.
15912357|NCT03555721|Diagnostic Test|Biopsy|Tissue will be collected to identify pre-cancerous or cancerous cells
15912358|NCT03555721|Diagnostic Test|CytID|CytID™ is an adjunctive process that is a noninvasive, pain-free, chair-side procedure for assessment of suspicious oral cavity lesions using a brush swab. The test is based on an objective measure of gross changes in the nuclear DNA content of oral epithelial cells; thereby, providing information about the pre-cancerous or cancerous state of a lesion.
15912359|NCT03555721|Diagnostic Test|hpvID|hpvID™ testing can detect all major HPV types and shows the current HPV status of the patient. This provides additional clinical information to correlate and compare hpvID™ trends with routine standard of care biopsy or cytology results.
15912360|NCT03555708|Other|Physical Therapy|Physical therapy will be implemented three times a week with subjects over an eight week span. Each physical therapy session will last 40-minutes and will be conducted by a licensed physical therapist.
15912361|NCT03555695|Behavioral|Karate Classes|Eligible subjects will engage in twice-weekly karate classes for 10 weeks, specifically designed for individuals with early to middle stage PD, focused on incorporating upper and lower limb movements in multiple directions, increasing awareness throughout the body, shifting body weight and rotation, relaxation of the muscles, improving reaction time, using complex repetitive actions to improve coordination, footwork training and centered weight shifts to help with fall prevention, and striking shields for self-defense and stress relief.
15912362|NCT03555695|Behavioral|Pre-Intervention Focus Group|At the pre-intervention focus group, the study logistics will be reviewed, informed consent process will occur, the subject will complete a brief, individual pre-intervention assessment focused on overall mobility, gait, balance, mood, neurological status, and quality of life, and the subjects will be prompted to share aloud their thoughts on exercise, balance, and mindfulness practices in general and in PD specifically, and any expectations or preconceptions that they have regarding karate classes for PD.
15912363|NCT03555695|Behavioral|Post-Intervention Focus Group|At the post-intervention focus group, the pre-intervention assessments will be readministered, along with an assessment of the subject's global impression of change. Subjects will be prompted to share their thoughts on how the intervention impacted their overall wellbeing, balance, and mindfulness; whether the intervention achieved their expectations; and they will be asked to provide feedback for improvements.
15912364|NCT03555682|Dietary Supplement|2-HOBA|2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate
15912365|NCT03555682|Dietary Supplement|Placebo|Placebo Comparator
15912541|NCT03554395|Biological|Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Gastric cancer|CIK cells was activated by PD-1 inhibitor and bispecific antibody of anti-CD3/MUC1
15943033|NCT03318419|Drug|Cytarabine|10mg/㎡ q12h SC d1-14
15912366|NCT03555669|Other|Depression Treatment|The depression treatment program combines measurement-based antidepressant treatment with PST with clinical response appropriate to the level of depressive severity. Patients scoring 0-4 on the PHQ-9, indicating no depression, receive no treatment. Patients scoring 5-9 on the PHQ-9, indicating mild depressive symptoms that likely are not a full major depressive episode, are offered PST. Patients scoring 10 or above on the PHQ-9, indicating moderate-to-severe depressive symptoms, are first offered anti-depressants. For this group, PST will be an alternative or augmentation option for those who do not tolerate or respond to antidepressant treatment. All patients' depressive severity is monitored with the option of modifying their treatment plan if their symptoms worsen or do not improve.
15912367|NCT03555656|Behavioral|Repeated intervention|Repetition twice a year of a 2-h group session educating patients at foot hygiene and ulcer prevention
15912368|NCT03555656|Behavioral|Single session|Single 2-h group session educating patients at foot hygiene and ulcer prevention
15912369|NCT03555630|Diagnostic Test|Thromboelastogram|Blood sample processing for thromboelastogram
15912370|NCT03555617|Drug|TD-1473|oral capsule/tablet, QD
15912371|NCT03555617|Drug|Itraconazole|oral solution, QD
15912372|NCT03555604|Diagnostic Test|Gastric ultrasound|Gastric ultrasound to measure antrum cross sectional area
15912373|NCT03555591|Drug|Trelagliptin|Trelagliptin tablets
15912374|NCT03555578|Drug|Leuprorelin Acetate|Leuprorelin Acetate Injection Kit
15912375|NCT03555565|Drug|Alogliptin and Metformin hydrochloride|Alogliptin and Metformin hydrochloride combination tablets
15912376|NCT03555552|Device|Anticoagulation and Thrombosis Point of Care Test(AT-POCT)|Capillary action automatically draws blood into the channel containing printed assay reagents which solubilize upon contact with blood and react with analytes of interest.
15912377|NCT03555552|Device|Duke Central Automated Laboratory (DCAL)|DCAL measurement of INR will occur by an ACL TOP 750 Analyzer (IL Inc.), and LDH by standard enzymatic activity assay will be run on the automated Beckman DxC800.
15912378|NCT03555539|Drug|Danicopan|Oral tablet.
15912379|NCT03555526|Drug|Esomeprazole 40mg|Nexium (esomeprazole), 40mg, bid, for 14 days
15912380|NCT03555526|Drug|Amoxicillin|amoxicillin, 1000mg, bid, for 7 days (day 1-day 7)
15912381|NCT03555526|Drug|metronidazole|metronidazole, 500mg, bid, for 7 days (day 8-14)
15912382|NCT03555526|Drug|Levofloxacin 500mg|levofloxacin 250mg, bid, for 7 days (day 8-14)
15912383|NCT03555526|Drug|Clarithromycin ER|clarithromycin 500mg, bid, for 7 days (day 8-14)
15912384|NCT03555526|Drug|Esomeprazole 40mg|Nexium (esomeprazole), 40mg, bid, for 10 days
15912385|NCT03555526|Drug|Dibismuth trioxide|Dibismuth trioxide，KCB F.C. TABLETS，300mg，qid, for 10 days
15912386|NCT03555526|Drug|metronidazole|metronidazole, 500mg, tid, for 10 days (day 1-10)
15912387|NCT03555526|Drug|tetracycline|tetracycline 500mg, qid, for 10 days
15912388|NCT03555513|Procedure|living kidney transplantation|receiving kidney transplantation from living donor
15912389|NCT03555500|Other|Non fasting|Non fasting group is allowed for clear fluids and food up to the time of the procedure.
15912390|NCT03555487|Drug|18F-choline PET|5mCi of 18F-FCH will be injected intravenously. PET imaging will be performed on PET/CT scanner. PET/CT from skull base to diaphragm will be started at 50 minutes after the injection.
15912391|NCT03555474|Procedure|Theta burst stimulation|Patients were given intermittent TBS to the affected hemisphere and continuous TBS to the unaffected hemisphere for 4 weeks along with physiotherapy.
15912392|NCT03555474|Procedure|Functional Electrical Stimulation|Patients were given functional electrical stimulation of affected upper extremity for four weeks along with physiotherapy.
15912393|NCT03555474|Procedure|Physiotherapy|Patients received active and passive physiotherapy of the affected extremity for four weeks.
15912394|NCT03555448|Drug|Once daily immunosuppression regimen|Intervention focuses on the type of regimen, in this case the intervention arm will receive a once daily regimen for immunosuppression compared to the twice daily regimen.
15912395|NCT03555448|Drug|Twice daily immunosuppression regimen|This is the arm which we are designating the standard, which will be the comparison to the active drug arm.
15912396|NCT03555435|Other|Moving Forward On Your Own|Participants in this group will use the online program on their own for 6 weeks.
15912397|NCT03555435|Behavioral|Moving Forward with Peer Support|Participants in this group will use the online program on their own for 6 weeks with the support of a peer coach. Peer coaching sessions will consist of 6 15-20 minute sessions one time per week. Sessions will be guided by a Moving Forward Peer Support Manual.
15912398|NCT03555435|Behavioral|Wait|Participants in this group will wait 6 weeks.
15912401|NCT03555396|Behavioral|SMART Couples 2|The intervention will consist of 4 sessions with activities designed to strengthen communication and support within the couple to improve adherence to antiretroviral therapy and increase linkage to drug treatment services. The activities are based on cognitive-behavioral therapy. Participants' adherence will be monitored continuously through electronic monitoring devices and surveys completed at baseline and follow-up periods.
15912402|NCT03555396|Behavioral|Standard of Care|Standard of Care consists of an appointment with an AIDS Center nurse at baseline and two months later. Under current Standard of Care in Almaty, no behavioral intervention is provided. Participants obtain prescription refills and give blood for viral load and CD4 tests once every 6 months.
15912403|NCT03555383|Diagnostic Test|Coagulation factor levels|The minimal functional hemostasis reserve capacity are defined by triggers as hematocrit: 27%, platelets: 30 G/l, Fibrinogen (FI): 1g/l, FII-FV-FVII-FX: 30%, Antithrombin III: 40%, FXIII: 60% levels. The estimate blood volume methodology is used for to determine the amount of allowable blood loss in volume (ml) that does not require replacement based on current and trigger levels. The individualized pyramid of intervention defined as hemostasis reserve capacity are followed at every studied patient. All measurements and calculations are performed before liver transplantation (T1), at arrival on Intensive Care Unit (T2) and 12-24-48 hours after liver transplantation (T3-4-5).
15913651|NCT03545815|Biological|anti-mesothelin CAR-T cells|Cells will be infused on day 0.
15912404|NCT03555370|Behavioral|Vestibular Exercise Intervention|The vestibular exercise intervention group will complete behavioral management activities, and prescribed in--office/at home vestibular exercises from four groups: 1) gaze stability training (integrated eye and head movements on fixed target), 2) visual motion training (integrated eye and head movements on moving target), 3) standing balance (standing with eyes closed in different stances), and 4) dynamic gait (walking with head turns and eye movements). Participants will be prescribed to one of four levels of these exercise groups based on presentation of symptoms/impairment as indicated on VOMS. Progression through the levels will be based on symptom tolerance and successful completion of all exercises at the current level.
15912405|NCT03555370|Behavioral|Standard of Care|The standard of care consists of standardized in office/at home behavioral management including sleep, hydration, nutrition, and stress management interventions.
15912406|NCT03555357|Other|Platelet Rich Fibrin|Platelet Rich Fibrin (PRF) is the next generation of PRP and contains very high concentrations white blood cells, fibrin and a small amount of mesenchymal stem cells found circulating in our bloodstreams. Due to a lack of anticoagulant in the tube, PRF becomes a gel after 15-20 minutes of being isolated. These properties make PRF useful in reconstructive and aesthetic medicine but may also be beneficial for scar therapy in the same way PRP is currently used.
15912407|NCT03555357|Other|Platelet Rich Plasma|Platelet Rich Plasma (PRP) has been used in surgical settings to stimulate healing and promote tissue regeneration. In the field of cosmetic medicine, PRP has been used topically or as an injection to stimulate collagen production and enhance the efficacy of cosmetic procedures such as fat transfer, hair loss therapies, laser treatments, and microneedling. Harvested PRP has platelets, fibrin, and white blood cells, which contribute to wound healing, neocollagenesis, and elastogenesis
15912408|NCT03555344|Other|Mantra Chikitsa|Specific Mantra were given to chants for 15 mins and resting in the impact of chants for following 15 mins.
15912409|NCT03555331|Behavioral|Child Safety Control Intervention|In the study period which spanned from early infancy through age 3 years, the child safety intervention group was given an educational program with messages focused on child and home safety, guided by the American Academy of Pediatrics and the Academy's guide for health supervision, Bright Futures. The observation-only study extension will not include any intervention, rather it will assess any long term outcomes from the education given to parents when their children were 0-2 years old.
15912410|NCT03555331|Behavioral|Responsive Parenting Intervention|During infancy, the Responsive Parenting group was given an educational program containing messages providing developmentally appropriate guidance to parents of infants on responsive parenting and healthy lifestyle aimed at preventing rapid weight gain in infancy and overweight at age 3 years. The new study period will not include any intervention, rather it will assess any long term outcomes from the education given to parents when their children were 0-2 years old.
15912411|NCT03555318|Other|Ambulatory visit|All patients will have an ambulatory visit with the cardiologist.
15912412|NCT03555318|Other|Combined ambulatory visit|Both the geriatrician and cardiologist will evaluate the patient and cardiac treatment will be agreed on between both specialists.
15912413|NCT03555318|Other|Geriatric intervention|After the geriatric assessment, measures to improve frailty will be started.
15912414|NCT03555305|Drug|Insulin Glargine|Administered SC
15912415|NCT03555305|Drug|Lantus|Administered SC
15912416|NCT03555292|Drug|11C-PiB|11C-PIB with 555MBq were intravenously injected into the patients immediately before the PET/CT scans
15912417|NCT03555279|Behavioral|PHAT Life: Preventing HIV/AIDS Among Teens--PS Arm|HIV Prevention Behavioral Health Intervention delivered by Probation Staff
15912418|NCT03555279|Behavioral|PHAT Life: Preventing HIV/AIDS Among Teens--YR Arm|HIV Prevention Behavioral Health Intervention delivered by Youth Representatives
15912419|NCT03555266|Device|NSS-2 Bridge|NSS-2-Bridge auricular therapy will be given in addition to standard of care ERAS protocol.
15912420|NCT03555266|Device|Sham NSS-2 BRIDGE|NSS-2-Bridge sham will be used in addition to standard of care ERAS protocol.
15912421|NCT03555253|Behavioral|Resilience-Based Program for Support Partners of PwMS|Support Partners will participate in six resilience coaching Program Sessions conducted weekly by a study resilience coach. PwMS will participate in the initial and final coaching Program Sessions with their Support Partners. The MyHealios Resilience Program for PwMS and their Support Partners has been designed to be interactive and include skills-based activities led by the Resilience coach. This includes skills of communication, problem solving, and learning about resilience and cognition in MS.
15912422|NCT03555240|Other|Biobank creation and Pharmacogenetic analysis|Collection of biological samples (blood, serum, plasma) form patient enrolled in the Emilia Romagna rheumatoid arthritis registry and genotyping genomic DNA samples, and assessing the association between genotypes and response to biological drugs, using multivariate and data-mining approaches that includes also clinical and demographic parameters.
15912423|NCT03555227|Procedure|USG PECS2 with Drug A (active)|Ultrasound guided Pecs 2 blocks with 0.25% levobupivacaine
15912424|NCT03555227|Procedure|USG PECS2 with Drug P (placebo)|Ultrasound guided Pecs 2 blocks with placebo (0.9% saline)
15912425|NCT03555227|Procedure|Wound infiltration with Drug P (placebo)|Wound infiltration at the end of surgery with Drug P (0.9% saline)
15912426|NCT03555227|Procedure|Wound infiltration with Drug A (active)|Wound infiltration at the end of surgery with 0.25% levobupivacaine
15912427|NCT03555214|Other|Manual Therapy based on soft tissues|"Manual Therapy:
~Technique of suboccipital inhibition.
~Cranial frontal technique.
~Cranial sphenoid technique.
~Cranial fourth ventricle technique.
~Antero-posterior abdominal-sacral technique."
15912428|NCT03555214|Other|Control group|"Placebo treatment:
~The patient remains supine and the therapist sits on a stool at the bedside with the forearms resting on the couch. Both hands are placed on the posterolateral part of the patient's head and the position is maintained for 10 minutes without exerting any force or movement."
15912429|NCT03555214|Other|Manual Therapy based on structural techniques|"Manual Therapy:
~Technique of manipulation of the occipito-atlanto-axoidea joint (OAA).
~Articulation technique of the high cervical spine (C0-C1).
~Postero-anterior articular technique of C2-C7 in supine position.
~Postero-anterior articular technique of C2-C7 in prone position.
~Manipulative technique of the flapper C7-T1.
~Dorsal spinal manipulative technique (T1-T8).
~Lumbosacral global manipulative technique."
15912542|NCT03554395|Procedure|Cryotherapy|the maximum tumor length≥2 cm，cool down the lesion,result in degeneration, necrosis or loss of the lesion.
15912430|NCT03555214|Other|Manual Therapy based on soft tissues and structural techniques|"Manual Therapy:
~Technique of suboccipital inhibition.
~Cranial frontal technique.
~Cranial sphenoid technique.
~Cranial fourth ventricle technique.
~Antero-posterior abdominal-sacral technique.
~Technique of manipulation of the occipito-atlanto-axoidea joint (OAA).
~Articulation technique of the high cervical spine (C0-C1).
~Postero-anterior articular technique of C2-C7 in supine position.
~Postero-anterior articular technique of C2-C7 in prone position.
~Manipulative technique of the flapper C7-T1.
~Dorsal spinal manipulative technique (T1-T8).
~Lumbosacral global manipulative technique."
15912431|NCT03555201|Other|Manual therapy|protocol of soft tissues techniques
15912432|NCT03555201|Other|Regular treatment control.|Regular treatment control.
15912433|NCT03555188|Drug|Ondansetron|Ondansetron is a highly selective receptor antagonist (5-HT3RA)
15912434|NCT03555175|Other|Eccentric exercise|The group make hamstring eccentric exercise. The participants have to do 12 serie of 6 repeats
15912435|NCT03555175|Other|Proprioception|The group have to do three kinds of exercise in a inestable area during 15 second in 2 repeats for each one
15912436|NCT03555175|Other|Control group|Any exercise
15912437|NCT03555162|Other|fMRI|Imaging examination
15912447|NCT03555136|Drug|Vortioxetine|Treatment with vortioxetine as per local SmPC
15912448|NCT03555123|Drug|Simdax|Levosimendan2.5mg/ml
15912449|NCT03555110|Behavioral|Personality Factor Battery Test (PFB Test)|Psychological instrument built for personality evaluation from the model of the Five Great Factors (FGF), that includes the following dimensions: Neuroticism, Extroversion, Socialization, Effort / Commitment), focusing on the component of the aspects of Neuroticism.
15912450|NCT03555110|Behavioral|Eye Movement Desensitization and Reprocessing Therapy (EMDR)|"It is a psychotherapeutic approach effective on treatment for trauma and post-traumatic stress disorder. It is an intervention that allows the desensitization of negative emotions from traumatic experiences.This therapy modifies memories that have been processed non-adaptively and become painful and dysfunctional memories. During the procedure, the patient is encouraged to move the eyes from side to side, associating these movements with a target situation, previously defined at the beginning of the session. The ocular movements can be replaced by tactile or sonorous stimuli. The series of stimuli must continue until the memory of the traumatic event can be reprocessed adaptively, that is, without the emotional, negative or painful process associated with that memory."
15912451|NCT03555097|Procedure|incremental pressure support|Inspiratory positive airway pressure (IPAP) gradually increases from 10 to 24 cm water column (cmH2O) with 2 water column (cmH2O) increments. The expiratory positive airway pressure (EPAP) remains 4 water column (cmH2O), and each pressure level is maintained for 5 to 10 minutes.
15912452|NCT03555084|Device|Extension of Virto B-Titanium|In ear Hearing aid device individually modeled to ear canal geometry to compensate an individual Hearing loss.
15912453|NCT03555084|Device|Virto B-Titanium|In ear Hearing aid device individually modeled to ear canal geometry to compensate an individual Hearing loss.
15912454|NCT03555071|Biological|Vaccine manufactured at commercialized scale|Single subcutaneous injection of the investigated live attenuated varicella vaccine (0.5 ml) on Day 0
15912455|NCT03555071|Biological|Vaccine manufactured at trial-scale|Single subcutaneous injection of the control live attenuated varicella vaccine (0.5 ml) on Day 0
15912456|NCT03555058|Other|Treatment escalation|Treatment escalation per TDM and physician's decision.
15912457|NCT03555045|Procedure|conducting the slanted recession technique on the superior and inferior poles|conducting the slanted recession technique on the superior and inferior poles of the muscle based on far and near deviations.
15912458|NCT03555045|Procedure|conducting the augmented recession technique on the muscle|conducting the augmented recession technique on the muscle for 1 to 1.50 mm more compared with the standard method.
15912459|NCT03555032|Drug|Talimogene laherparepvec (T-VEC)|One dose of 1 x 106 PFU/mL. Two doses of 1 x 108 PFU/mL. Given by intra-tumoural (i.t.) injection.
15912460|NCT03555019|Dietary Supplement|Formulaid|Supplementation with ARA and DHA
15912461|NCT03555019|Dietary Supplement|MCT-oil|Supplementation with medium chain fatty acids
15912462|NCT03555006|Other|"Dual ultrasound reading local vs remote"|The examination will be interpreted by a department's radiologist and by a remote radiologist in blind of the first interpretation and a posteriori by a third radiologist.
15912463|NCT03555006|Other|"Dual ultrasound reading local vs local"|The examination will be interpreted by two department's radiologists and a posteriori by a third radiologist.
15912464|NCT03554993|Drug|CC-99677|CC-99677
15912465|NCT03554993|Other|Placebo|Placebo
15912466|NCT03554980|Drug|Silver Diamine Fluoride|SDF will be applied with a brush.
15912467|NCT03554980|Drug|Sodium Fluoride varnish|NaF will be applied with a brush
15912468|NCT03554941|Device|noise stimulation|noise stimulation
15943034|NCT03318419|Drug|Pegaspargase|2500U/m2 im d1
15912470|NCT03554915|Other|Ketamine-based protocol|For profoundly agitated (physically violent) patients, intramuscular ketamine 5 mg/kg will be administered first line. For severely agitated patients, intramuscular ketamine 3 mg/kg will be administered first line.
15912471|NCT03554915|Other|Midazolam-based protocol|For profoundly agitated patients, intramuscular midazolam 15 mg will be administered. For severely agitated patients, intramuscular midazolam 5 mg will be administered.
15912472|NCT03554902|Procedure|Endoscopic gastric tubulization|Endoscopic gastric tubulization is performed using the CE marked endoscopic suture device Overstitch (Apollo Endosurgery, Austin, Tx. USA).
15912473|NCT03554889|Biological|NK Cell adaptive transfer|Nimotuzumab will enhance the ADCC effect of NK Cell adaptive transfer
15912474|NCT03554889|Drug|Nimotuzumab|Nimotuzumab will enhance the ADCC effect of NK Cell adaptive transfer
15912475|NCT03554876|Device|Multi-Im Machined transepithelial component.|Once the implant is placed, the implant loading protocol will be decided following the clinical criteria. When implant loading is to be done, then the Multi-IM machined transepithelial component is connected to the implant.
15912476|NCT03554876|Device|Multi-Im Nanogolden transepithelial component|Once the implant is placed, the implant loading protocol will be decided following the clinical criteria. When implant loading is to be done, then the Multi-IM Nanogolden transepithelial component is connected to the implant.
15912477|NCT03554876|Device|Multi-Im Ti-Golden transepithelial component|Once the implant is placed, the implant loading protocol will be decided following the clinical criteria. When implant loading is to be done, then the Multi-IM Ti-Golden transepithelial component is connected to the implant.
15912478|NCT03554863|Device|Nasal High Flow Oxygen|Nasal High Flow Oxygen using Optiflow device of Fisher and Paykel
15912479|NCT03554863|Device|Facial Mask|Preoxygenation with facial mask
15912480|NCT03554850|Device|Trevo® Retriever|Stent retriever procedure
15912481|NCT03554811|Device|Functional electrical stimulation assisted supine cycling (FESC)|A supine cycle ergometer attached to a six-channel stimulator will be used for FESC. Surface electrodes will be applied to the hamstrings, quadriceps, and calf muscles on both legs. Muscles will be stimulated at specific stages throughout the cycling phase. Each session will start with a 1 minute motor-driven passive cycling warm-up at a rate of 20 revolutions per minute. Patients will continue with passive, active-assisted, or active cycling, according to their level of participation. If the patients stop cycling actively, the ergometer will revert to passive cycling.
15912482|NCT03554811|Other|Conventional early exercise and mobility interventions|These interventions will be based on the patient's alertness and medical stability, and includes activities to maintain or increase limb range of motion and strength, in and out of bed mobility, sit to stand, and transfer training, as well as assisted ambulation.
15912483|NCT03554798|Biological|nOPV2 (monovalent oral polio vaccine)|"50 IPV and/or OPV vaccinated participants aged 1 to 5 years vaccinated with candidate 1 or 2; two 10‸6 CCID50 (50% cell culture infective dose) doses separated by 28 days.
~162 infants enrolled at 6 weeks of age (-7 to +14 days) vaccinated with 3 doses of bOPV at 6, 10 and 14 weeks of age and 1 dose of IPV at 14 weeks of age, followed at 18-22 weeks of age with one 10‸5 CCID50 dose of candidate 1 or 2."
15912484|NCT03554785|Behavioral|Clinician and Non-clinician staff training|"An optimized training program for non-clinical staff, clinicians and administrators developed by TFI's National LGBT Health Education Center that will include content-specific webinars and Office Hours for specific CHC consultations to optimize the provision of SGM health services at each CHC and to foster the development of in-house expertise to sustain ongoing training and quality improvement in the provision of care for LGBT patients."
15912485|NCT03554772|Drug|DFN-15 (Celecoxib Oral Solution) 62.5 mg|Oral Solution
15912486|NCT03554772|Drug|DFN-15 (Celecoxib Oral Solution) 125 mg|Oral Solution
15912487|NCT03554772|Drug|DFN-15 (Celecoxib Oral Solution) 250 mg|Oral Solution
15912488|NCT03554772|Drug|Placebo|Oral Solution
15912489|NCT03554759|Drug|Avatrombopag|Avatrombopag dosing will be determined by the treating physician in conjunction with the FDA-approved package insert.
15912490|NCT03554746|Other|GC group|"core stability training: hold 5s/rep, 20 reps/times
~supine, pelvic posterior tilt with TrA contraction.
~supine, pelvic posterior tilt and maintain bil. knee on 90 degrees.
~All four position with leg raise
~Stretching ex. : hold 15 s/reps, 5 reps/times
~Hamstring
~Quadriceps
~Additional gluteal muscle control training: hold 10 s/reps, 20 reps/times 1st to 2nd:
~clam ex. without resistance
~single leg bridge with maintain bil. ASIS even level 3rd to 4th: maintain 1st to 2nd ex. with resistance 5th:
~maintain 3rd to 4th ex.
~single leg standing on rock board to maintain balance 6th:
~maintain 5th ex.
~lunge ex. without hip internal rotation"
15912491|NCT03554746|Other|CG group|"core stability training: hold 5s/rep, 20 reps/times
~supine, pelvic posterior tilt with TrA contraction.
~supine, pelvic posterior tilt and maintain bil. knee on 90 degrees.
~All four position with leg raise
~Stretching ex. : hold 15 s/reps, 5 reps/times
~Hamstring
~Quadriceps"
15912492|NCT03554733|Behavioral|ReInventing Yourself after SCI|6-week, manualized, cognitive-behaviorally based group educational intervention
15912493|NCT03554720|Device|ATTUNE PS Knee|The ATTUNE PS Knee is the standard implants.
15912494|NCT03554720|Device|ATTUNE S+ PS Knee|The ATTUNE S+ PS Knee is the enhanced fixation.
15912495|NCT03554707|Genetic|SGT-53|2.1 mg DNA/m2 or 2.8 mg DNA/m2 twice weekly
15912496|NCT03554707|Radiation|Radiation|Standard radiation plan
15912497|NCT03554707|Drug|Irinotecan|50mg/m2/dose IV daily for five days in a 4-week cycle
15912498|NCT03554707|Drug|Temozolomide|100mg/m2 PO daily for five days in a 4-week cycle
15912499|NCT03554707|Drug|Bevacizumab|10mg/kg IV every two weeks in a 4-week cycle
15912500|NCT03554694|Dietary Supplement|Prebiotics|Galactooligosaccharides (GOS) (prebiotics) will be consumed by the participants for 4-6 weeks
15912501|NCT03554694|Dietary Supplement|Maltodextrin (placebo)|Maltodextrin (placebo) will be consumed by the participants for 4-6 weeks
15912502|NCT03554668|Diagnostic Test|Blood draw|We take blood samples at pre-op and subsequent time points, up to three months post op.
15912536|NCT03554421|Procedure|Percutaneous tibial nerve stimulation|A 20Hz electrical current is given via an electrode inserted through the skin over the posterior tibial nerve above the medial malleolus of the foot and the nerve is stimulated until a motor reflex of the big toe is acheived. Treatment is then continued for 30 minutes at this level. The treatment is then repeated for a total of 10 sessions within a 2 week period.
15912503|NCT03554655|Device|Momentum app|The Momentum system consists of a smartphone app (for the patient) and a web portal (for the provider). Information entered in the app by the patient will automatically be transferred to the web portal for the provider to see. While one goal of the system is to support SDM, the Momentum app is not a classic decision aid focusing on finding a choice to a one-off treatment decision. Instead, the Momentum app is an aid to support some of the underlying elements behind SDM such as collaboration with one's provider, awareness and eliciting of one's needs, preferences and values.
15912504|NCT03554642|Device|Walkbot|Walkbot is a Robot Assisted Gait Training System. This system is designed to maximize muscle strength, range of joint motion, and gait function while participants engage in a virtual reality game.
15912505|NCT03554642|Behavioral|Physical Therapy|30-minute session of standard physical therapy focused on pre-gait and/or gait training activities 5-days per week during the duration of their stay (14 days).
15912506|NCT03554629|Device|Capnography CO2 cannula sampling Flexiterline (CCSF) designs with supplemental O2|Use of 8 post-market nasal CO2 cannula sampling filterlines; 4 nasal only sampling ports manufactured by Medtronic, Salter, Hudson/Teleflex and FlexiCare) and 4 post-market oral/nasal sampling ports manufactured by Medtronic, Salter, Dispo-Med and Westmed during scripted activity with supplemental O2.
15912507|NCT03554616|Other|Chlorfenapyr LLIN|Dual active ingredient Long Lasting Insecticidal Net
15912508|NCT03554616|Other|pyriproxyfen LLIN|Dual active ingredient Long Lasting Insecticidal Net
15912509|NCT03554616|Other|Piperonyl butoxide LLIN|Combination insecticide and synergist Long Lasting Insecticidal Net
15912510|NCT03554616|Other|Standard LLIN|Standard Long Lasting Insecticidal Net with one insecticide
15912511|NCT03554603|Behavioral|Modified Report|An abbreviated version of the microbiology report indicating that growth is present and the physician should call the lab for further details if clinically important.
15912512|NCT03554590|Behavioral|carbohydrate counting|patients will attend a 5 meetings-structured training to learn how to manage their insulin therapy depending on the amount of carbohydrates contained in foods
15912513|NCT03554590|Behavioral|insulin therapy according to standard care|patients will not manage their insulin therapy depending on the amount of carbohydrates contained in foods, but will follow a fix basal bolus scheme
15912514|NCT03554577|Device|Hearing Aid without NR|"Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs.
~Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of noise suppression and good speech quality."
15912515|NCT03554577|Device|Hearing Aid with NR_A|"Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs.
~Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of noise suppression and good speech quality."
15912516|NCT03554577|Device|Hearing Aid with NR_B|"Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs.
~Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of noise suppression and good speech quality."
15912517|NCT03554577|Device|Hearing Aid with NR_C|"Each participant will be fitted with the 4 different Noise Reduction (Sound Changing) principles on the same hearing aid, saved to 4 manual programs.
~Noise Reduction principle is a sound processing algorithm to remove noise from a speech signal to improve the speech intelligibility and comfort. The experimental conditions vary in their parametrization to result in different degrees of noise suppression and good speech quality."
15912518|NCT03554564|Behavioral|VOICE/Fitbit|During the VOICE (intervention) phase, participants will use the digital health platform plus Fitbit walking activity tracking for a total of five weeks (one week run-in phase plus four week study phase)
15912519|NCT03554564|Other|Daily self-reported exercise adherence|During usual care, patients will self-report on a daily basis if they met the walking exercise goal consistent with instructions from their clinician. Self-report will be recorded as a daily categorical (yes/no) variable.
15912520|NCT03554538|Behavioral|Web app exercises program|Exercise on an evidence based program for shoulder pain with web app animations to improve performance and adherence
15912521|NCT03554538|Behavioral|Exercise program|Exercise on an evidence based program for shoulder pain
15912522|NCT03554525|Dietary Supplement|Fat-binder damm|3 sticks every day during 12 months
15912523|NCT03554525|Dietary Supplement|Placebo|3 sticks every day during 12 months
15912524|NCT03554512|Other|Telehealth virtual appointment|Appointment with NICU clinician via telehealth equipment.
15912525|NCT03554499|Procedure|Bichectomy with hydrodissection|Intraoral removal of buccal fat pads using hydrodissection technique
15912526|NCT03554499|Procedure|Bichectomy|Intraoral removal of buccal fat pads using conventional technique
15912527|NCT03554486|Drug|Fiasp|Fiasp insulin will be used for 2 weeks with the 670G hybrid closed-loop system
15912528|NCT03554486|Drug|Novolog|Novolog insulin will be used for 2 weeks with the 670G hybrid closed-loop system
15912532|NCT03554460|Device|dual-limb NIV|dual-limb NIV was served with servo i ventilator
15912533|NCT03554447|Drug|Escitalopram 20 mg tablet plus Pentoxifylline 400Mg Tablet|Selective serotonin reuptake inhibitor plus phosphodiesterase inhibitor with anti-inflammatory properties
15912534|NCT03554447|Drug|Escitalopram 20 mg tablet + Placebo|Selective serotonin reuptake inhibitor plus placebo
15912535|NCT03554434|Biological|AM0010|AM0010
15912537|NCT03554408|Drug|10-1074-LS|Subcutaneous injection of 10-1074-LS
15912538|NCT03554408|Drug|10-1074-LS|Intravenous infusion of 10-1074-LS
15912539|NCT03554408|Drug|3BNC117-LS|Subcutaneous injection of 3BNC117-LS
15912543|NCT03554382|Other|system to support self-management of hypertension|The patients are provided with a home BP monitor. Thereafter they will be asked to use the self-management support system and self-report, once daily in the evening, via their own mobile phone during eight weeks. At each occasion, the patients first answer the questions on wellbeing, symptoms, lifestyle, medication intake and side effects and then measure their BP and pulse, and when these data (mean of three readings) are input into the mobile phone, they automatically register in the database. During intervention the paient has regular access to self-reported data via graphs
15912544|NCT03554356|Device|CryoBalloon Focal Ablation System|CryoBalloon Focal Ablation System
15912545|NCT03554343|Diagnostic Test|test for SMN1 exon 7 deletion|Newborns are screened for SMN1 exon 7 deletion through standard NBS practice Positive case are promptly referred to reference centers
15912546|NCT03554330|Other|Radiofrequency catheter ablation|(1) In control group: only graded balloon atrial septostomy will be carried out and there is no radiofrequency catheter ablation. (2) In single-RFA group: after graded balloon atrial septostomy identical to control group, radiofrequency catheter ablation will be performed immediately around the rim of created inter-atrial fenestration. (3) In double-RFA group: the first step is radiofrequency catheter ablation on fossae ovalis; and then the other two steps are identical to the single-RFA group (BAS and RFA around the rim of fenestration).
15912547|NCT03554330|Other|Balloon atrial septostomy|Graded balloon atrial septostomy is performed in all patients.
15912548|NCT03554317|Drug|Testosterone cypionate|Depot (DEPO)-Testosterone Injection, for intramuscular (IM) injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. Depot (DEPO)-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
15912549|NCT03554317|Drug|Nivolumab|Nivolumab Injection, 100 mg/10 mL (10 mg/mL) or 40 mg/4 mL (10 mg/mL), is a clear to opalescent, colorless to pale yellow liquid, which may contain light (few) particulates. The drug product is a sterile, non-pyrogenic, single-use, isotonic aqueous solution formulated at 10 mg/mL in sodium citrate, sodium chloride, mannitol, diethylenetriaminepentacetic acid (pentetic acid), and polysorbate 80 (Tween 80), at potential hydrogen (pH) 6.0 and includes an overfill to account for vial, needle, and syringe holdup. It is supplied in 10-cc Type I flint glass vials, stoppered with butyl rubber. The clinical study product is a sterile solution to be administered through parenteral intravenous infusion.
15912550|NCT03554304|Drug|WCK 5222|FEP-ZID IV solution administered as either a 30- or 60-minute IV infusion)
15912551|NCT03554304|Drug|IV placebo matched to WCK 5222 / Moxifloxacin IV solution|"Placebo (IV placebo matched to FEP-ZID IV solution) and
~1 placebo capsule matched to moxifloxacin overencapsulated tablet"
15912552|NCT03554304|Drug|Moxifloxacin 400-mg|Moxifloxacin 400-mg positive control (overencapsulated tablet)
15912553|NCT03554291|Drug|Famotidine 20 MG|Famotidine 20 mg capsule taken daily for 24 weeks.
15912554|NCT03554291|Other|Placebo|Placebo capsule taken daily for 24 weeks.
15912555|NCT03554265|Drug|Somatropin|Genotropin given by injection
15912556|NCT03554252|Other|Frequencies|Results are presented as natural frequencies (e.g. the drug was effective for 1 out of 10 people) while side effects are presented as percentages (e.g. 40% participants experienced severe side effects)
15912557|NCT03554252|Other|Percentages|Results are presented as percentages (e.g. the drug was effective for 10% of people) while side effects are presented as natural frequencies (e.g. 4 out of 10 participants experienced severe side effects)
15912558|NCT03554239|Genetic|genotyping|Blood sample
15912559|NCT03554226|Behavioral|NeuroPsychiatric Inventory Clinician (NPI-C)|All scales that will be administered to the patient during this study, (ADL, MMSE, QoL-AD, NPI and CMAI), are the subject of recommendations for the management of patients with AD (HAS 2009, HAS 2011)
15912560|NCT03554213|Biological|Typhoid Conjugate Vaccine|Typbar TCV Vi-TT (Vi capsular polysaccharide conjugated with tetanus toxoid protein) manufactured by Bharat Biotech International Limited
15912561|NCT03554200|Drug|Empagliflozin|Standard of Care + Empagliflozin: 10 mg (tablets) once daily
15912562|NCT03554200|Drug|Placebo|Standard of Care + Placebo: Matching Placebo (tablets) once daily
15912563|NCT03554187|Device|Ultrasonic periodontal Debridement, with appropriate device|Dental procedure that includes therapeutic interventions such as scaling to remove calculus and all soft deposits, root planing to eliminate subgingival calculus and smooth the tooth surface, and root débridement to eliminate subgingival biofilm and lightly mineralized deposits.
15912564|NCT03554187|Biological|Analyzes of periodontopathogenic bacteria|Collection of plaque, to analyze the bacteria in the pocket
15912565|NCT03554187|Genetic|IL1B test|susceptibility to periodontal disease (scratch swab onto the tongue) (no invasive)
15912566|NCT03554187|Biological|Salivary Sampling|Salivette to chew. To analyse salivary microbiota
15912567|NCT03554187|Device|Halitosis measure|With appropriate device : halimeter
15912568|NCT03554174|Drug|Low Dose Psilocybin|0.1 mg/kg psilocybin capsule
15912569|NCT03554174|Drug|Placebo|microcrystalline cellulose capsule
15912570|NCT03554174|Drug|Medium Dose Psilocybin|0.3 mg/kg psilocybin capsule
15912571|NCT03554161|Biological|Tocilizumab (TCZ)|Patients with refractory BD associated uveitis will receive Tocilizumab therapy, the efficacy and corticosteroids-tapering effects will be evaluated.
15912572|NCT03554148|Other|No intervention|This is purely an observational study. Groups SSI/No SSI are defined by the occurence of a surgical site infection.
15912573|NCT03554135|Other|Personalization of palliative radiotherapy|Observe the rates of pain control and the need to retreat patient, when applied to personalization of indications and maximum technological support for palliative radiotherapy to patients with < 6 months prognostic score attendance
15912574|NCT03554122|Procedure|Shotblocker|Patients spinal injections were performed with Shotblocker placed onto injection site
15912575|NCT03554122|Procedure|Placebo|Patients spinal injections were performed without Shotblocker
15912576|NCT03554109|Drug|Leucovorin|L-Glutamic acid, N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-, calcium salt
15912577|NCT03554109|Drug|5-Fluorouracil|5-fluoro-2,4 (1H,3H)-pyrimidinedione
15912578|NCT03554109|Drug|Aldoxorubicin HCl|albumin-binding prodrug of doxorubicin HCl
15914690|NCT03537534|Drug|Lidocaine Jet Injector|Applying Lidocaine following endourologic procedure
15912579|NCT03554109|Drug|nab-Paclitaxel|Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin
15912580|NCT03554109|Biological|ETBX-011|Ad5 [E1-, E2b-]-CEA
15912581|NCT03554109|Biological|ETBX-051|Ad5 [E1-, E2b-]-Brachyury vaccine
15912582|NCT03554109|Biological|ETBX-061|Ad5 [E1-, E2b-]-mucin 1[MUC1]
15912583|NCT03554109|Biological|GI-4000|Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins
15912584|NCT03554109|Biological|GI-6207|CEA yeast vaccine
15912585|NCT03554109|Biological|GI-6301|Brachyury yeast vaccine
15912586|NCT03554109|Drug|Avelumab|Avelumab
15912587|NCT03554109|Biological|ALT-803|Recombinant human super agonist interleukin-15 (IL-15) complex
15912588|NCT03554109|Biological|haNK|NK-92 [CD16.158V, ER IL-2]
15912589|NCT03554109|Drug|Cyclophosphamide|2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
15912590|NCT03554109|Drug|Doxorubicin HCL|Doxorubicin HCL
15912591|NCT03554109|Drug|paclitaxel|paclitaxel
15912592|NCT03554096|Dietary Supplement|2-HOBA|2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate
15912593|NCT03554083|Drug|Atezolizumab|Given IV
15912594|NCT03554083|Drug|Cobimetinib|Given PO
15912595|NCT03554083|Biological|Tiragolumab|Given IV
15912596|NCT03554083|Drug|Vemurafenib|Given PO
15912597|NCT03554070|Procedure|Thulium Fiber Laser Enucleation of the Prostate|Thulium laser enucleation of the prostate is performed using the two-lobe or en-bloc techniques. Incision depth is limited to the circular fibers of the prostate capsule. The left lobe is enucleated first, starting at the 5 o'clock position. The endoscope is then introduced counterclockwise at the 2 o'clock position. Next, an incision is made at 12 o'clock and extended to the level of the verumontanum. The incisions at the 12 and 2 o'clock positions are connected, and the left lobe is enucleated into the bladder. The right lobe of the gland is enucleated in a similar manner: the initial incision at 7 o'clock was made clockwise, an 11 o'clock incision is then extended along the capsule to join with the previous cut. The final step is morcellation of hyperplastic nodes.
15912598|NCT03554070|Device|"Thulium Fiber Laser Urolase"|"Urolase system (NTO IRE-POLUS, Russian Federation) is a thulium doped fiber laser.
~Max. power of 120 W and energy of 8 J. Wavelength - 1,94 µm, incision depth - 0,2 mm."
15912599|NCT03554057|Diagnostic Test|Coronary Computed Tomographic Angiography|All low-risk patients referred for invasive coronary angiography will be potentially eligible to receive the intervention over a 12-month period. The intervention will include risk stratification using Coronary Computed Tomographic Angiography (CCTA) at HHS and NHS as an alternative to upfront invasive angiography. All CCTAs will be read by both a level 3-trained cardiologist and a radiologist. The results of the CCTA, coupled with evidence-based management recommendations will be sent to the referring physician and an invasive angiogram will be arranged only when indicated as per these management recommendations
15912600|NCT03554044|Drug|Anastrozole|Given PO
15912601|NCT03554044|Drug|Exemestane|Given PO
15912602|NCT03554044|Drug|Fulvestrant|Given IM
15912603|NCT03554044|Drug|Letrozole|Given PO
15912604|NCT03554044|Drug|Paclitaxel|Given IV
15912605|NCT03554044|Biological|Talimogene Laherparepvec|Given IT
15912606|NCT03554044|Drug|Tamoxifen|Given PO
15912607|NCT03554044|Drug|Nab paclitaxel|Given IV
15912608|NCT03554044|Drug|Gemcitabine|Given IV
15912609|NCT03554044|Drug|Carboplatin|Given IV
15912610|NCT03554031|Drug|Recombinant Human Growth Hormone (rhGH) Injection|Drug: Recombinant Human Growth Hormone Injection /Jintropin AQ, 30IU/10 mg/3ml/kit, 0.5 mg/m2/d for the first 4 weeks, then 1.0 mg/m2/d for subsequent 48 weeks; by subcutaneous injection, once per day for total 52 weeks.
15912611|NCT03554018|Drug|Acetaminophen|Acetaminophen 500-1000mg every 6 hours
15912612|NCT03554018|Drug|Ibuprofen 600 mg|Ibuprofen 600mg every 6 hours
15912613|NCT03554018|Behavioral|Educational intervention|Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS (National Institute of Arthritis and Musculoskeletal and Skin Diseases) Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp)
15912614|NCT03554018|Drug|Placebo oral capsule|To match acetaminophen, patients will take one or two capsules every 6 hours
15912615|NCT03554005|Drug|PEG Interferon Alfa-2b|Participants receive PEG interferon alfa-2b administered by SC injection, in doses ranging from 0.75 mcg/kg OW up to 7.5 mcg/kg OW, for up to 40 weeks of treatment.
15912616|NCT03554005|Drug|Acetaminophen|Participants receive 500 to 1000 mg of acetaminophen orally 30 minutes prior to PEG interferon alfa-2b administration, and continue acetaminophen 500 to 1000 mg after administration every 4 to 6 hours as needed. The total daily dose of acetaminophen should not exceed 3000 mg.
15912617|NCT03553992|Behavioral|POP-6:|"90 days of Facebook messaging, weekly live sessions targeting tobacco use and tailored to SGM young adults
~Drug: nicotine patch 14-day supply of nicotine patch"
15912618|NCT03553992|Behavioral|TSP-6:|"90 days of Facebook messaging, weekly live sessions targeting tobacco use
~Drug: nicotine patch 14-day supply of nicotine patch"
15912619|NCT03553979|Behavioral|Stress management program (SM)|Participants follow the SM program.
15912620|NCT03553979|Behavioral|Stress management + Buddy program (SM-B)|In addition to receiving the SM, participants in the SM-B will also receive one-to-one support through a buddy.
15912621|NCT03553966|Procedure|Prophylactic|Tooth Brushing HA 3x daily repeated cleaning of all teeth using a standardized electric tooth brush and a non-fluoridated tooth paste containing microcrystalline hydroxylapatite.
15912622|NCT03553966|Procedure|Cleaning teeth|Tooth Brushing F 3x daily repeated cleaning of all teeth using a standardized electric tooth brush and a fluoridated tooth paste.
15912623|NCT03553966|Device|Restorative dentistry|If in a subject a significant increase of carious lesions will be observed, her/his parents are informed about the necessity for further caries preventive measures (e.g. dietary changes, use of fluoride products, reduction of cariogenic microflora with chlorhexidine, xylitol chewing gum, etc.) and caries preventive treatment (removing caries and placing a restoration) by the study centers is offered.
15912628|NCT03553927|Dietary Supplement|Low Energy Diet|Caloric restriction to achieve weight loss
15912629|NCT03553927|Other|NHS advice on healthy eating|Advice on energy requirements as per the British Dietetic Association
15912630|NCT03553914|Drug|PLM60|PLM60 will be administered via intravenous infusion in 28-day cycles for up to 7 cycles.
15912631|NCT03553901|Procedure|Acupressure|Acupressure was performed before the injection onto GB30 point
15912632|NCT03553875|Drug|Memantine Hydrochloride|Participating children and adolescents with Non-Verbal Learning Disorder and related conditions (NVLD-RC) who meet the eligibility criteria will be randomly assigned to memantine for the course of the 12-week randomized controlled trial (RCT).
15912633|NCT03553875|Drug|Placebo|Participating children and adolescents with Non-Verbal Learning Disorder and related conditions (NVLD-RC) who meet the eligibility criteria will be randomly assigned to placebo for the course of the 12-week randomized controlled trial (RCT).
15912634|NCT03553862|Behavioral|collaborative care|The intervention arm will receive collaborative care from a team of healthcare professionals that consists of pharmacist, physicians, nurses and dietitians. Patients in the intervention group will also receive clinical interventions carried out by the pharmacist.nurses and dietitians as well as a pharmacist.
15912635|NCT03553849|Dietary Supplement|Very low calorie diet|The VLCD is a prescribed diet with well-balanced macro and micronutrients. It is intended for significant weight loss in a short period of time, is intended only for the extremely obese, and must be completed under the supervision of a trained physician.
15912636|NCT03553836|Biological|Pembrolizumab|Administered as an intravenous (IV) infusion every 3 weeks (Q3W)
15912637|NCT03553836|Other|Placebo|Administered as an IV infusion every 3 weeks (Q3W)
15912638|NCT03553823|Procedure|Skin biopsies|At Baseline, two 6-mm punch biopsies were taken, one from the identified active plaque (TCS ≥ 6) and one from never-lesional skin. At the End-of-study Visit, one biopsy was taken from the same area of the active plaque sampled at Baseline.
15912639|NCT03553810|Drug|Entresto|Entresto (Valsartan/sacubitril) 100mg once a day, up-titrating to 200mg or maximum 400mg to achieve target systolic blood pressure below 140 mmHg, over a duration of 52 weeks. If necessary, amlodipine and/or hydrochlorothiazide may be added to achieve target systolic blood pressure.
15912640|NCT03553810|Drug|Valsartan|Valsartan 40mg once a day, up-titrating to 80 or maximum 160 mg to achieve target systolic blood pressure below 140mmHg, over a duration of 52 weeks. If necessary, amlodipine and/or hydrochlorothiazide may be added to achieve target systolic blood pressure.
15912641|NCT03553784|Other|Group delivered Low Intensity Cognitive Behavioural Therapy|The intervention is group-delivered, low-intensity CBT similar to that used in IAPT (Improving Access to Psychological Therapies) Services in England. This intervention is already being offered as part of standard care at the Intervention site, and will not be altered by the study protocol, other than the requirement to complete a few more questionnaires. The intervention group meets weekly for eight weeks, and is facilitated by a clinical psychologist, a psychological well-being practitioner and a clinical nurse specialist from the medical oncology team. Content of the intervention is broad CBT, combining aspects of second-wave CBT, with elements of Narrative Therapy and ACT.
15912642|NCT03553771|Device|LVIS and LVIS JR|Braided coil assist stents used for aneurysm embolization
15912643|NCT03553758|Drug|Ketamine|Subjects' brain waves will be monitored by EEG recording under ketamine general anesthesia over the course of approximately 60 minutes. Patients pain and dissociation will be assessed before the induction of ketamine and periodically after. Approximately 1 hour after ketamine induction, Midazolam will be administered to reduce patient dissociation.
15912644|NCT03553745|Behavioral|Gentle Yoga Intervention|10-week exercise program structured around gentle yoga practice.
15912645|NCT03553745|Behavioral|Rigorous Yoga Intervention|10-week exercise program structured around rigorous yoga practice.
15912646|NCT03553745|Behavioral|Physical Exercise Intervention|10-week exercise program structured around cardiovascular exercise.
15912647|NCT03553732|Other|Registry|Patients who are diagnosed with prostate cancer and elect to be monitored by an Active Surveillance protocol by the Urology Clinic at Zuckerberg San Francisco General Hospital and Trauma Center will be included in this group. The intervention is the implementation of a registry, designed to replace existing but suboptimal systems for tracking patients. All Active Surveillance patients monitored by the clinic will be included.
15912648|NCT03553693|Other|RAPID-VL study intervention|"Viral load (VL) ordering flowsheet with periodic health facility performance feedback
~Rapid near-point-of-care VL testing and telephone delivery of results
~Structured VL counseling package"
15912649|NCT03553680|Behavioral|Emotion-Focused CBT|10 CBT Sessions to improve emotional regulation and emotional intelligence.
15912650|NCT03553667|Device|Standard group|Use radial arterial line to monitor mean arterial pressure
15912651|NCT03553667|Device|ClearSight|Use Edwards EV1000 Clinical Platform NI with ClearSight finger sleeve to monitor SV(stroke volume)
15912652|NCT03553654|Diagnostic Test|low dose CT|CT-based protocol for detection of anthracycline-induced myocardial dysfunction at early stages
15912653|NCT03553628|Other|Chlorhexidine, Propolis and Clove Oil mouthwash|Chlorhexidine Gluconate 0.12% with Propolis 1% and Clove Oil 1% mouthwash
15912654|NCT03553628|Other|Chlorhexidine mouthwash|Chlorhexidine HCL 0.12% mouthwash
15912655|NCT03553615|Drug|Ivermectin Pill|oral anti-parasitic agent taken as a weekly dose for four weeks
15912696|NCT03553329|Drug|dabrafenib|Monthly biological assessment which included: blood count, a blood electrolytes, an creatininemia, a dosage of urea, a dosage of transaminases, of gammaGT, of phosphatases alkaline, of LDH and of albumin.
15912697|NCT03553316|Drug|PK101-002|-(Single) PK101-002
15912656|NCT03553602|Radiation|HDR Brachytherapy + EBRT + STAD|"HDR Brachytherapy implant: 2 fractions of 12 Gy to the prostate/ proximal SV.
~EBRT: 50.4 Gy in 28 fractions to the pelvic lymph nodes +/- para-aortic nodes, with SIB up to 70 Gy to the PET- positive lesions.
~6 months hormonal therapy(LHRH agonist and anti-androgen[until end of radiotherapy])"
15912657|NCT03553589|Other|Blood sampling|Blood sampling (10 mL) prior to standard care (e.g. surgery, medical treatment)
15912658|NCT03553576|Drug|Low volume bolus|Administration of a low-volume bolus (6.25 mL) of greater density solution (0.1% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
15912659|NCT03553576|Drug|High volume bolus|Administration of a high-volume bolus (10 mL) of lower density local anesthetic (0.0625% bupivacaine with fentanyl 2.0 mcg/mL) at 250 mL per hour given by CADD pump.
15912660|NCT03553563|Drug|D961H capsule 10mg|All Groups can select either capsule or sachet during the study.
15912661|NCT03553563|Drug|D961H sachet 10mg|All Groups can select either capsule or sachet during the study.
15912662|NCT03553550|Other|biospecimen collection|Peripheral blood collection Archival tissue collection
15912663|NCT03553537|Drug|Decitabine|10mg/m² iv on day 1-5
15912664|NCT03553537|Drug|Cyclophosphamide|750mg/m² iv on day 6
15912665|NCT03553537|Drug|Doxorubicin|DOX
15912666|NCT03553537|Drug|Vincristine|1.4mg/m² iv on day 6
15912667|NCT03553537|Drug|Prednisone|100mg/m² po on day6-10
15912668|NCT03553524|Other|morning HIIT --> afternoon HIIT|Arm 1 will start with morning HIIT at visit 2 and afternoon HIIT at visit 3
15912669|NCT03553524|Other|afternoon HIIT --> morning HIIT|Arm 2 will start with afternoon HIIT at visit 2 and morning HIIT at visit 3
15912670|NCT03553511|Procedure|Vaginal vault suspension to the uterosacral ligaments|Laparoscopic hysterectomy with vaginal vault suspension to the uterosacral ligaments
15912671|NCT03553511|Procedure|McCall culdoplasty|Vaginal hysterectomy with McCall culdoplasty
15912672|NCT03553498|Drug|IV acetaminophen|acetaminophen given intravenously
15912673|NCT03553498|Drug|IV placebo|given intravenously
15912674|NCT03553498|Drug|hydromorphone|hydromorphone given intravenously
15912675|NCT03553485|Device|Transcutaneous vagus nerve stimulation|The transcutaneous auricular vagus nerve stimulator Parasym consists of a stimulation unit and a dedicated ear electrode. The stimulation unit, having approximately the size of a common mobile phone, sends out the electrical impulses. It is connected with the ear electrode, which patients wear like an earphone. The patient can regulate and adapt the intensity of the stimulation (current intensity) according to his/her individual sensitivity, which can vary from day to day or even over the period of the therapy.
15912676|NCT03553485|Device|Sham|Sham Earclip electrodes are electrodes that appear identical to functioning electrodes, however do not deliver any stimulation due to removed wiring.
15912677|NCT03553485|Radiation|Radiotherapy|Standard treatment for included patients
15912678|NCT03553459|Diagnostic Test|Trendelenburg Maneuver|In the Trendelenburg position, the body is laid supine, or flat on the back with the feet higher than the head by 15-30 degrees. The venous return increases in the trendelenburg position which in turn increases the stroke volume.
15912679|NCT03553446|Drug|children receiving sevoflurane|Children receiving pre-determined sevoflurane concentration using modified Dixon's up-and-down method
15912680|NCT03553433|Drug|Apremilast 30mg|Anti-psoriatic drug
15912681|NCT03553433|Drug|Placebo Oral Tablet|Indistinguishable tablets not containing apremilast, Placebo Oral Tablet
15912682|NCT03553407|Device|Low Level Laser - Pulse|The laser will be applied at a single point in contact, perpendicular to the surface of the tooth in a region that presents healthy enamel, towards the pulp chamber. The laser chosen was the low power diode laser with the following protocols: Group 1 (880nm, 30mW, 3.6 J / cm², 25 Hz) and Group 2 (880nm, 30mW, 3.6 J / cm²), after 10 minutes we will ask to the patient again from 0 to 3 the level of pain, to then proceed to the anesthetic phase.
15912683|NCT03553407|Device|Low Level Laser - continuous|The laser will be applied at a single point in contact, perpendicular to the surface of the tooth in a region that presents healthy enamel, towards the pulp chamber. The laser chosen was the low power diode laser with the following protocols: Group 1 (880nm, 30mW, 3.6 J / cm², 25 Hz) and Group 2 (880nm, 30mW, 3.6 J / cm²), after 10 minutes we will ask to the patient again from 0 to 3 the level of pain, to then proceed to the anesthetic phase.
15912684|NCT03553407|Device|Low Level Laser - placebo|placebo will be applied at a single point in contact, perpendicular to the surface of the tooth in a region that presents healthy enamel, towards the pulp chamber. The laser chosen was the low power diode laser with the following protocols: Group 1 (880nm, 30mW, 3.6 J / cm², 25 Hz) and Group 2 (880nm, 30mW, 3.6 J / cm²), after 10 minutes we will ask to the patient again from 0 to 3 the level of pain, to then proceed to the anesthetic phase.
15912685|NCT03553394|Drug|Ringer's Acetate|Will receive a fluid bolus immediately (Ringer's Acetate 5 mls/kg bw) if oliguric/anuric for two consecutive hours
15912686|NCT03553381|Other|hypocaloric balanced diet|
15912687|NCT03553368|Diagnostic Test|HF-NIV-MR|MRI data will be acquired with the use of HF-NIV.
15912688|NCT03553368|Diagnostic Test|HF-NIV-PET|PET data will be acquired with the use of HF-NIV.
15912689|NCT03553368|Diagnostic Test|MR|MRI data will be acquired without the use of any device as a reference.
15912690|NCT03553368|Diagnostic Test|PET/CT breath hold|PET/CT data will be acquired in inspiratory breath hold without the use of HF-NIV.
15912691|NCT03553368|Diagnostic Test|CPAP-MR|MRI data will be acquired with the use of CPAP.
15912692|NCT03553355|Device|Infrared Laser Moxibustion|We will use SX10-C1 laser moxibustion devices (Shanghai Wonderful Opto-Electrics Tech Co Ltd, Shanghai, China) for the ILM and SILM groups. Four laser probes will be synchronously aligned with 4 points (tST36 (bilateral), CV4, and CV6 acupoints) and we will irradiate each acupoint 2 cm away from the skin surface for 20 minutes. Each patient will receive this treatment twice per week for six weeks (12 sessions total).
15912693|NCT03553355|Device|Sham Infrared Laser Moxibustion|The sham laser moxibustion instrument appears to be identical as the real one.
15912694|NCT03553342|Drug|Corticoids|Patients will receive corticosteroids therapy: 1mg/kg of prednisolone daily for seven days.
15912695|NCT03553342|Other|Placebo|Patients will receive placebo for seven days.
15912698|NCT03553316|Combination Product|PK101|-(Combination) PK101-001, PK101-002
15912699|NCT03553303|Drug|Sacubitril / Valsartan Oral Tablet|Increasing doses of Sacubitril/Valsartan
15912700|NCT03553290|Device|A.R.C. FOX Laser-FOX Q-810nm|805-810 nm dichotomous laser, 12 Watt within the power of sensitive parts of the affected teeth
15912701|NCT03553290|Procedure|Control|Mechanical debridement alone
15912702|NCT03553277|Other|transfluthrin|passive emanator with formulated transfluthrin
15912703|NCT03553277|Other|placebo|passive emanator with formulated inert ingredients
15912704|NCT03553264|Device|Virtual Reality Rehabilitation|Track Speed Racing 3D game will run with HMD 'Revelation' 3D VR Headset and each HMD group patient will be instructed to perform the game protocol uninterruptedly for 20min/day, while sitting on a chair or sofa.
15912705|NCT03553264|Other|Vestibular Rehabilitation|The home exercise program will include a patient-tailored combination of adaptation (without and with the target moving in pitch and yaw planes for 1min each three times per day), substitution, habituation, and balance exercises
15912706|NCT03553238|Drug|Chidamide|Chidamide will be administrated at a dose of 10mg/day in PDT-ETP-ALL protocol.
15912707|NCT03553238|Drug|Dexamethasone|Dexamethasone will be added in Pre-phase Regimen, Induction-Regimen, Consolidation-Module of PDT-ETP-ALL protocol.
15912708|NCT03553238|Drug|vincristine|Vincristine will be added to Induction-Regimen, Consolidation-Module and Maintenance-Module of PDT-ETP-ALL protocol.
15912709|NCT03553238|Drug|Cyclophosphamide|CTX will be added to Induction-Regimen, Consolidation-Module and Maintenance-Module of PDT-ETP-ALL protocol.
15912710|NCT03553238|Drug|Idarubicin|IDA will be added to Induction-Regimen and Consolidation-Module of PDT-ETP-ALL protocol.
15912711|NCT03553238|Drug|Pegaspargase|PEG-ASP will be added to Induction-Regimen and Consolidation-Module of PDT-ETP-ALL protocol.
15912712|NCT03553238|Drug|Adriamycin|Adriamycin will be added to Consolidation-Module of PDT-ETP-ALL protocol.
15912713|NCT03553238|Drug|Methotrexate|Methotrexate will be added to consolidation module of PDT-ETP-ALL protocol.
15912714|NCT03553238|Drug|6-Mercaptopurine|Mercaptopurine will be added to Consolidation-Module and Maintenance-Module of PDT-ETP-ALL protocol.
15912715|NCT03553238|Drug|Etoposide|VP-16 will be added to Consolidation-Module of PDT-ETP-ALL protocol.
15912716|NCT03553238|Drug|Cytarabine|AraC will be added to Consolidation-Module of PDT-ETP-ALL protocol.
15912717|NCT03553238|Procedure|Bone marrow aspiration|Bone marrow aspiration and additional tests will be performed in all module of PDT-ETP-ALL protocol.
15912718|NCT03553238|Procedure|Intrathecal injection|Intrathecal injection chemotherapy will be performed in PDT-ETP-ALL protocol.
15912719|NCT03553238|Radiation|Radiation therapy|Radiation therapy will be performed for mediastinum and/or central nervous system leukemia in PDT-ETP-ALL protocol.
15912720|NCT03553238|Genetic|NGS|Next-Generation-Sequencing (NGS) will be performed in PDT-ETP-ALL protocol.
15912721|NCT03553238|Procedure|allogeneic hematopoietic stem cell transplantation|Allo-HSCT will be performed for patients with available donor in PDT-ETP-ALL protocol.
15912722|NCT03553238|Diagnostic Test|Flow-MRD|Flow-MRD will be added to PDT-ETP-ALL for bone marrow and cerebrospinal fluid samples.
15912723|NCT03553238|Diagnostic Test|FISH|FISH will be performed in PDT-ETP-ALL for bone marrow samples.
15912724|NCT03553238|Diagnostic Test|Flow immunophenotyping|Flow immunophenotyping will be performed in PDT-ETP-ALL protocol.
15912725|NCT03553238|Diagnostic Test|Karyotyping|Karyotyping will be performed in PDT-ETP-ALL protocol.
15912726|NCT03553225|Dietary Supplement|Placebo|Identical formulation as the treatment consisting of colored maltodextrin using artificial colors
15912727|NCT03553225|Dietary Supplement|Concord Grape extract 1|1 g Concord Grape extract in 2 capsules
15912728|NCT03553225|Dietary Supplement|Concord Grape extract 2|500 mg Concord Grape extract in 2 capsules
15912729|NCT03553212|Radiation|tomotherapy|20-23 Gy in 2 fractions on the whole prostate gland +/- seminal vesicles and 24-27 Gy in 2 fractions as simultaneous integrated boost (SIB) on the dominant intraprostatic lesion (DIL) 2 weeks in all.
15912730|NCT03553199|Device|TRS, Tissue Retraction System|Tissue Retraction System
15912731|NCT03553186|Drug|Tranexamic Acid 100 MG/ML|TXA lavage solution (200 cc sterile normal saline + 5 g tranexamic acid 100mg/ml (50cc)) will be poured into the surgical field and left in contact for five minutes. This will occur after instrumentation. Excess solution will be suctioned away using a non-cell saver suction.
15912732|NCT03553186|Drug|Placebo|Placebo solution (200 cc sterile normal saline + placebo TXA ampule (50cc)) will be poured into the surgical field and left in contact for five minutes. This will occur after pedicle screw instrumentation. Excess solution will be suctioned away using a non-cell saver suction.
15912733|NCT03553173|Other|So-Lo-Mo|So-Lo-Mo is an innovative intervention based on mobile technologies and its capacity to trigger behavioral changes. In this sense, the App is a complement to pharmacological therapies to quit smoking providing personalised motivational messages, physical activity monitoring, lifestyle advices and distractions (mini-games) to help pass the cravings. The main objective of this App is to improve patient's adherence to the smoking cessation process making use of behavioral techniques in the form of motivational messages and/or Short Message Service (SMS).
15912734|NCT03553173|Behavioral|Psychological advice|Provision of information about smoking and smoking cessation process, as well as supporting behavioral changes through the provision of new skills and strategies. The most used methods are the motivational interview and the cognitive-behavioral therapy
15912735|NCT03553173|Drug|Bupropion Pill|Formulated as a 150 mg long discharge pill, usually being prescribed a daily dose of 300 mg, except for week one which would be prescribed 150 mg per day. The usual length of the treatment ranges from 7 to 9 weeks. However, 12 weeks treatments could be prescribed for severe cases of smokers.
15912736|NCT03553173|Drug|Varenicline Pill|Formulated as 0,5 mg and 1 mg pills, and the dose should be progressively incremented during the first days in order to facilitate tolerance. The recommended length of the treatment is 12 weeks, although longer treatments could be necessary for severe smokers.
15912737|NCT03553160|Other|Frequent Self-Weighing|Were given scales to weigh themselves daily. Change in weight was measured at the beginning and end of the two year observation period.
15912774|NCT03552835|Procedure|partial caries removal upto firm dentin|occlusal caries were treated by partial caries removal upto firm dentin followed by Glass Ionomer Cement placement as a base and composite restoration
15912775|NCT03552822|Other|ERAS Protocol Implementation|Implementation of ERAS Protocol Implementation
15912776|NCT03552809|Device|Gigaa Cheese 810 nm Diode Laser|Diode Laser assisted frenectomy operation.
15912738|NCT03553147|Other|SARC-F score, handgrip test and impedancemetry|Participation in the study will be offered to any patient admitted to the geriatric ward, those who meet the inclusion criteria and do not have exclusion criteria will have to complete the SARC-F questionnaire during their stay, and to do the handgrip test and impedancemetry performed by a third party. Biological data (albumin, pre-albumin and C-Reactive Protein) and anthropometric data will be collected and analyzed to determine if the patient is malnourished or not, and the results of SARC-F will be compared between these 2 groups.
15912739|NCT03553134|Diagnostic Test|transcranial doppler ultrasound scan|Carried out at 4 different times: at birth, 6, 24 and 48 hours of life (duration: 10 minutes)
15912740|NCT03553134|Diagnostic Test|ultrasound scan centered on the arterial canal|Carried out at 4 different times: at birth, 6, 24 and 48 hours of life (duration: 5 minutes)
15912741|NCT03553121|Other|walking|walking and not walking
15912742|NCT03553108|Drug|Olaparib Treatment A|Olaparib Tablet 25 mg
15912743|NCT03553108|Drug|Olaparib Treatment B|Olaparib Tablet 100 mg
15912744|NCT03553108|Drug|Olaparib Treatment C|Olaparib Tablet 150 mg
15912745|NCT03553108|Drug|Olaparib Treatment D|Olaparib Tablet 250 mg
15912746|NCT03553095|Procedure|Periodontal Surgery|Samples will be collected from patient in need of periodontal therapy (surgical procedures i.e. gum surgery, tooth extraction and or dental implant surgery). As standard during this procedures remnant tissue is otherwise discarded.
15912747|NCT03553082|Drug|Sevoflurane|Fentanyl 2 µg/kg for induction of anesthesia and sevoflurane 2% for maintenance
15912748|NCT03553082|Drug|Propofol|Propofol 5-6 mg/kg and fentanyl 2 µg/kg for induction of anesthesia and propofol 250-300 µg/kg/min for maintenance
15912749|NCT03553056|Other|NZ Step Away app|Access to 10 modules of the app (namely: drinkers profile, goal setting, rewards, cravings, strategies, support, reminders, high risk times, moods, activities)
15912750|NCT03553056|Other|Modified NZ Step Away app|Access to 2 modules of the app (namely: drinkers profile and goals setting)
15912751|NCT03553043|Behavioral|Intervention|Energy label condition.
15912752|NCT03553043|Behavioral|Control|No label
15912753|NCT03553030|Device|coronary artery angiography|In all patients authors performed a coronary artery angiography for detection of coronary artery stenosis.
15912754|NCT03553017|Device|Binocular OCT|Participants in the study will undergo OCT imaging using a prototype binocular OCT imaging system (Envision Diagnostics, Inc., CA) twice to assess repeatability.).
15912755|NCT03553004|Drug|Niraparib Treatment|Niraparib treatment by mouth (oral)
15912756|NCT03552991|Drug|Agiocur Pregranules|6g before breakfast and 12g after dinner for first 28 days, and no medication for next 28 days for washout
15912757|NCT03552978|Behavioral|Tech-Facilitated IC Intervention|The Integrated Care (IC) treatment protocol for smoking cessation is a PTSD-informed intervention that has been adapted to be delivered over video or telephone and to incorporate technological components, including the Stay Quit Coach (SQC) smart phone application (app) and the iCO Smokerlyzer device and app. Content of sessions is consistent with that delivered in the IC treatment protocol for veteran smokers with posttraumatic stress disorder (PTSD). The experimental intervention condition in the proposed study differs from the standard of care in that participants will be receiving tailored, individualized smoking cessation counseling for veterans with PTSD.
15912758|NCT03552978|Behavioral|VA Quitline|Participants in the control condition will receive the VA's standard care, which is referral to the VA Quitline. This active control condition involves weekly telephone sessions through the VA's proactive telephone Quitline, which is available to all veterans for up to 8 weeks. Participants will initiate the first call, and subsequent calls will be made by the Quitline counselor.
15912759|NCT03552965|Other|Robust Radiotherapy planning|Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that minimize the dose of radiation to normal tissue
15912760|NCT03552965|Other|Margin-Based Radiotherapy planning|Investigator will plan Intensity-Modulated Radiation Therapy (IMRT) using calculations that introduce a margin to the target area
15912761|NCT03552952|Other|No intervention|No intervention
15912762|NCT03552913|Procedure|One year before awareness-raising phase in favour of Enhanced Recovery After Surgery|One year before awareness-raising phase in favour of Enhanced Recovery After Surgery
15912763|NCT03552913|Procedure|One year after awareness-raising phase in favour of Enhanced Recovery After Surgery|One year after awareness-raising phase in favour of Enhanced Recovery After Surgery
15912764|NCT03552913|Procedure|No specific program toward improving practices|No specific program toward improving practices
15912765|NCT03552900|Behavioral|7cups Mobile App|Participants who receive the 7 Cups mobile app will get access to direct online social support by messaging with a listener, participating in group chats as well as evidence-based information and exercises to promote their mental health.
15912766|NCT03552900|Behavioral|Bliss|Participants who receive the Bliss app will get access to an app that that provides access to important community, health, wellness, academic, and support resources.
15912767|NCT03552887|Procedure|Cardiac Surgery|Any type of cardiac surgery
15912768|NCT03552887|Procedure|Physiotherapy|Any type of physiotherapy intervention, performed by physiotherapists outside of the protocol
15912769|NCT03552874|Other|The Performance of Upper Limb Questionnaire (PUL)|
15912770|NCT03552861|Device|repetitive transcranial magnetic stimulation(rTMS)|Each patient will be given 5 treatment sessions per week for 2 weeks (a total of 10 sessions).In each rTMS conditioning session,1200 pulses of stimuli at an intensity of 100% rest motor threshold (RMT) will give over the left and rigt DLPFC.Each session is 45 minutes long and will be consisted of 10Hz stimulation trains (active) over the left DLPFC and 1Hz over the right DLPFC，Interval of 5 minutes each side.During rTMS blocks, the coil will be oriented tangential to the surface. For sham control rTMS blocks, the coil will be oriented 90◦ away from the scalp so that no pulses perturbed underlying neural tissue.
15912771|NCT03552848|Biological|MSC|MSC at a dose of 1000000 cells per kilogram of body weight will be given intravenously once every 4 days for 4 times
15912772|NCT03552835|Procedure|no caries removal|occlusal caries were treated with no caries removal and placement of stainless steel crown
15912773|NCT03552835|Procedure|partial caries removal upto soft dentin|occlusal caries were treated by partial caries removal upto soft dentin followed by Glass Ionomer Cement placement as a base and composite restoration
15912986|NCT03551080|Biological|Placebo|Saline administered intravenously
15912777|NCT03552809|Procedure|Conventional Frenectomy Operation|Frenectomy operation performed by surgical blades with suturing.
15912780|NCT03552783|Behavioral|FFL + Cognitive Behavioral Therapy|Participants in the intervention arm will receive the standard, 12-week program curriculum of Fathers for a Lifetime in addition to 12 weekly, one-hour, group CBT sessions, and three (3), one-hour, one-on-one therapy sessions throughout the 12-week FFL program. We will implement an individual and group CBT mental health intervention that will align with the topics addressed in the FFL weekly curriculum.
15912781|NCT03552783|Behavioral|Fathers for a Lifetime (FFL) only|"The participants in the comparison arm will receive the standard, 12-week program curriculum of Fathers for a Lifetime. The curriculum is broken into three categories:
~Personal responsibility
~Personal responsibility to your child
~Responsibility to your family and community"
15912782|NCT03552770|Drug|Bevacizumab|pro-re-nata repeated single or combined intra-vitreous injection of bevacizumab
15912783|NCT03552757|Drug|Semaglutide 1.0 mg|Subcutaneous (s.c.) injections of semaglutide once weekly at an escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week). The dose will be escalated to next level every 4 weeks.
15912784|NCT03552757|Drug|Semaglutide 2.4 mg|Subcutaneous injections of semaglutide once weekly at an escalating doses (0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week, 1.7 mg/week and 2.4 mg/week). The dose will be escalated to next level every 4 weeks.
15912785|NCT03552757|Drug|Placebo I (Semaglutide)|S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 2.4 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week, 1.7 mg/week and 2.4 mg/week). The dose will be escalated to next level every 4 weeks.
15912786|NCT03552757|Drug|Placebo II (Semaglutide)|S.c. injections of placebo once weekly at a similar dose escalation manner as semaglutide 1.0 mg (placebo matched to semaglutide 0.25 mg/week, 0.5 mg/week, 1.0 mg mg/week). The dose will be escalated to next level every 4 weeks.
15912787|NCT03552744|Other|Mailed training intervention|"PCPs from the intervention group will be mailed an intervention package that includes:
~2-page structured evidence summary on CRC screening and information about Colonoscopy & FIT (Decision box)
~patient decision aid (20-page booklet) on CRC screening for distribution to patients (Decision Aid)
~video example for the PCP, which illustrates a participatory approach to discussing CRC screening with a patient
~4-page abridged version of the booklet to support PCPs when they discuss CRC screening with patients during a clinical visit (Decision Board)
~individualized 1-page summary of PCP screening practices comparing their individual prescription patterns to group patterns, based on the data collected in 2017 (Performance card)
~2-page document that encourages PCPs still using the inferior guaiac-based FOBT to switch to FIT and includes list of laboratories from which they can order FIT
~sample FIT for PCPs who may not be familiar with its contents and use"
15912788|NCT03552731|Behavioral|Surveys|GAD 7 Survey and PHQ 9 Interventional survey will be administered in both groups.
15912789|NCT03552718|Biological|YE-NEO-001|Personalized recombinant yeast-based vaccine engineered to express multiple neoantigen epitopes (neoepitopes) based on an individual subject's tumor molecular profile.
15912790|NCT03552705|Drug|Tranexamic Acid|5-day course of oral standard adult oral tranexamic acid dosage of 1300 mg taken 3 times a day (3900 mg/day) and intravenous tranexamic acid during ACL reconstruction surgery (1 gram of iv TXA just prior to incision and 1 gram of iv TXA just prior to wound closure)
15912791|NCT03552705|Drug|Placebos|5-day course of oral placebo and intravenous saline during ACL reconstruction surgery
15912792|NCT03552692|Drug|Venetoclax|"Venetoclax (ABT-199) will be administered orally (800 mg daily). Patients will receive ABT-199 until disease progression, unacceptable toxicity, withdrawal of consent and/or the investigator determines that further therapy is not in the patient's best interest.
~Tumor Lysis Syndrome (TLS) is an important identified risk for Venetoclax in oncology studies. Since there are no available data on the risk of TLS in PTCL, the risk of TLS development should be closely monitored during the study.
~to avoid TLS ABT-199 will be administered according the following ramp up: W eek 1 day 1: 20 mg W 1 day 2-3: 50 mg W 1 day 4-7: 100 mg W 2: 200 mg W 3: 400 mg W 4 and following: 800 mg"
15912793|NCT03552679|Diagnostic Test|Echocardiography|Echocardiography
15912794|NCT03552666|Dietary Supplement|vitamin D3|
15912795|NCT03552653|Dietary Supplement|Vitafusion Extra Strength Vitamin D|Monitor Vitamin D blood levels
15912796|NCT03552627|Drug|Oxygen|Medical Oxygen
15912797|NCT03552614|Device|Upper limb robot-assisted rehabilitation|"Upper limb robot-assisted rehabilitation is performed with Armeo®Spring. It is a passive exoskeleton with five degrees of freedom that guarantees passive arm weight support with springs.
~The treatment was composed by 45 minutes of robotic training (5 times a week for 4 weeks) during which patients performed a customized pull of exergames."
15912798|NCT03552614|Other|physiotherapy|Patients undergo 45-minute treatment sessions 5 times a week for 4 weeks of physiotherapy, focused on gross and fine motor ability to promote independence in daily activities, and it is customized on patients' need.
15912799|NCT03552601|Other|traditional speed|ARDS patients are performed negative fluid balance strategy with intravenous furosemide (4mg/h) or continuous veno-venous hemofiltration. The target amount of every day's net negative fluid balance for the first three days is 1000mL.Termination of the strategy is performed when mean arterial pressure drops below 65mmHg or perfusion index drops below 0.82 or lactate increases above 2mmol/L or acute kidney injury occurs.
15912800|NCT03552601|Other|faster speed|ARDS patients are performed negative fluid balance strategy with intravenous furosemide (4mg/h) or continuous veno-venous hemofiltration. The target amount of every day's net negative fluid balance for the first three days is 1500mL.Termination of the strategy is performed when mean arterial pressure drops below 65mmHg or perfusion index drops below 0.82 or lactate increases above 2mmol/L or acute kidney injury occurs.
15912801|NCT03552588|Diagnostic Test|Continuous Electrocardiogram|A high-sensitivity, 14-day continuous ECG monitor.
15912802|NCT03552575|Drug|sacubitril/valsartan|Sacubitril is a prodrug neprilysin inhibitor used in combination with valsartan to reduce the risk of cardiovascular events in patients with chronic heart failure (NYHA Class II-IV) and reduced ejection fraction.
15912803|NCT03552575|Drug|Valsartan|is an angiotensin II receptor antagonist (commonly called an ARB, or angiotensin receptor blocker), that is selective for the type I (AT1) angiotensin receptor.
15914691|NCT03537534|Drug|Placebos|Applying surgilube following endourologic procedure
15912804|NCT03552562|Device|Fourier Domain Color Doppler Optical Coherence Tomography (FDOCT)|Fourier domain OCT is based on a local phase analysis of the backscattered signal and allows for bidirectional Doppler flow imaging.(Leitgeb et al. 2003a; Leitgeb et al. 2003b) It does not need reference arm scanning and records one full depth and Doppler profile in parallel. The system operates with an equivalent A-scan rate of 25 kHz and allows real time imaging of the color encoded Doppler information together with the tissue morphology at a rate of 2-4 tomograms (40 x 512 pixel) per second. Despite the high detection speed we achieve a system sensitivity of 86dB using a beam power of 500μW at the cornea. The fundus camera allows simultaneous view for selection of the region of interest. We observe bi-directional blood flow and pulsatility of blood velocity in retinal vessels with a Doppler detection bandwidth of 12.5 kHz and a longitudinal velocity sensitivity in tissue of 200μm/s. Diffuse luminance flicker will be applied during the measurements for 60 seconds.
15912805|NCT03552549|Biological|PEG-Intron|Polyethylene glycol (PEG)12000 Interferon alfa 2-b subcutaneous injection.
15912806|NCT03552549|Biological|INTRON A|Interferon alfa-2b, recombinant for intravenous injection.
15912807|NCT03552536|Drug|MK-8583|A single oral dose of MK-8583 in capsule form
15912808|NCT03552523|Device|Bionic Pancreas|During this arm the subject will ONLY use our bionic pancreas device with an insulin only configuration using a rapid-acting insulin analog. Subjects will wear a continuous glucose monitoring device (the Dexcom G5) as part of the bionic pancreas, and use the study provided glucose meter.
15912809|NCT03552523|Other|Usual Care|Subject will wear a continuous glucose monitoring device (the Dexcom G5) and use the study provided glucose meter.. Subject will not change their prescribed home insulin therapy regimen during this arm whether that be an insulin pump or multiple daily injections.
15912810|NCT03552510|Procedure|Oro-pharyngeal Administration of Mother's Milk|Infants will receive mother's milk (to the maximum of 0.2 ml ) by dropper to the oro-pharyngeal pouch, tongue and cheeks every 3 hours (5 minutes before time of feeding)
15912811|NCT03552497|Diagnostic Test|Radiomics|The high-throughput extraction of large amounts of quantitative image features from radiographic medical images
15912812|NCT03552484|Behavioral|Home Visit Program|Informed consent discussion, documentation; UPDRS I-IV, medical history, vitals, medication reconciliation, patient medical history and comorbidities; home safety assessment; psychosocial assessment of dyad, resource utilization questionnaire, caregiver medical history and comorbidities, MCSI; patient and caregiver short MoCA, satisfaction surveys, EQ5D; counseling, summarizing plan of care
15912813|NCT03552484|Behavioral|Usual Care/Online Survey|Patients and caregivers, if available, will be asked to complete an online survey that asks about demographics, disease history, resource utilization, and unmet needs. The will be asked to complete a follow-up survey 12 months after completion of the initial survey.
15912814|NCT03552471|Other|Laboratory Biomarker Analysis|Correlative studies
15912815|NCT03552471|Biological|Mirvetuximab Soravtansine|Given IV
15912816|NCT03552471|Other|Pharmacokinetic Study|Correlative studies
15912817|NCT03552471|Drug|Rucaparib Camsylate|Given PO
15912818|NCT03552458|Drug|Lactobacillus Reuteri Oral Solution [BioGaia]|BioGaia Lactobacillus Reuteri drops
15912819|NCT03552458|Drug|Placebos|Placebo will be identical in physical appearance and color to the study agent and will be made by the manufacturer
15912820|NCT03552445|Biological|Tetanus-diphtheria (Td) and PCV13|154 concomitant Td-PCV13 recipients: one dose of each vaccine administered on Day 0
15912821|NCT03552445|Biological|PCV13 alone|154 PCV13 recipients: one vaccine injection administered on Day 0
15912822|NCT03552445|Biological|Td alone|437 Td recipients: one vaccine injection administered on Day 0
15912823|NCT03552432|Drug|Alirocumab|the administration of Alirocumab by Subcutaneous injection 75mg every 2 weeks plus Rosuvastatin10mg/daily by oral for 9 months
15912824|NCT03552406|Biological|ISU104|Intravenous Infusion for 1 hour.
15912825|NCT03552406|Drug|Cetuximab|Intravenous Infusion for 1 hour (2 hours at initial dose)
15912827|NCT03552380|Drug|Entinostat|RP2D will be determined with a 6 patient safety lead-in. Entinostat will continue until disease progression or prohibitive toxicity. Cycles 1-4 are 21 day cycles. Cycles 5 and subsequent are 14 day cycles.
15912828|NCT03552380|Drug|Nivolumab|Nivolumab will continue until disease progression or prohibitive toxicity. Cycles 1-4 are 21 day cycles. Cycles 5 and subsequent are 14 day cycles.
15912829|NCT03552380|Drug|Ipilimumab|Ipilimumab will be administered in combination with entinostat and nivolumab for Cycles 1-4 only.
15912830|NCT03552367|Other|Personalized structured exercise program|The type of exercise offered to patients in this arm is precisely designed for obese patients according to age and physical fitness parameters. Patients are monitored using a heart rate monitor to evaluate treatment adherence and compliance
15912831|NCT03552367|Other|Non personalized non-structured exercise program|The type of exercise is non-structured and patients' heart rate is not monitored. Patients receive exercise recommendations without any personalization according to their fitness parameters
15912832|NCT03552354|Drug|Argatroban plus dual antiplatelet|A continuous argatroban infusion of 1.0 ug/kg per minute for 2-5 days adjusted to a target activated partial thromboplastin time of 1.75 X baseline (about 10%). For the first day, clopidogrel with loading dose 300mg, and aspirin 100mg were given, and followed by clopidogrel 75 mg and aspirin 100mg each day
15912833|NCT03552341|Other|Maternal iodine status|Urinary iodine concentration during pregnancy at 26 weeks' gestation (Bord in Bradford study) and at 12, 26 and 36 weeks' gestation, 6, 18 and 30 weeks postpartum (Hiba longitudinal study). This is primarily in the form of Iodine to Creatinine ratio, to take spot urine volume into account. There is no intervention in this observational study.
15912834|NCT03552328|Other|Lunch with Medical Student|Each student will bring provided lunches once a week to their elder participant's residence, and they will share lunch together for an hour once a week for six weeks. Students will enroll as Meals on Wheels volunteers and participate in the Meals on Wheels pre-program training. On the day of their scheduled lunch, students will first arrive at the Meals on Wheels designated meal-drop location and pick up two lunches, one for them and one for their assigned elder. They will then drive to their assigned elder's residence and eat lunch with them for one hour.
15912835|NCT03552328|Other|Control|Students will not bring provided lunches to an elder participant's residence. The elder participants in this arm will simply continue receiving daily meals from Meals on Wheels with no accompanying student.
15912836|NCT03552315|Dietary Supplement|Carbonated water with amino acids and chromium|The active carbonated water containing amino acids and chromium picolinate is consumed with a standardized test meal. Postprandial glucose and insulin response is documented for 180 minutes
15912837|NCT03552315|Dietary Supplement|Placebo Carbonated Water|The placebo carbonated water is consumed with a standardized test meal. Postprandial glucose and insulin response is documented for 180 minutes
15912838|NCT03552302|Behavioral|Yoga|"Yoga stretch warm-up exercise for 15 minutes.
~Five kinds of yoga correction method for 30 minutes (abdominal breathing, throat breathing, wind box breathing, nasal alternating breathing, buzzing breathing).
~Great rest for 15 minutes"
15912839|NCT03552289|Device|Cook Advance® Enforcer 35 Focal-Force Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter|The Enforcer balloon device will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula
15912840|NCT03552289|Device|Conventional angioplasty balloon catheters|Commercially available angioplasty balloon devices will be used in treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistula
15912841|NCT03552276|Drug|SUNPG18_07 I|injection
15912842|NCT03552276|Drug|SUNPG18_07 II|injection
15912843|NCT03552276|Drug|SUNPG18_07 III|injection
15912844|NCT03552263|Drug|T89 capsule|T89 capsules (75mg), orally, twice daily.
15912845|NCT03552263|Drug|Placebo capsule|Placebo capsules (0mg), orally, twice daily.
15912846|NCT03552250|Behavioral|Parenting for Lifelong Health for Young Children|In this study, the 12 sessions-PLH version for parents of young children (2-9 years) will be delivered. The PLH (2 - 9) programme is delivered in groups of parents and includes the following general content 1) One-on-one time, 2) Say what you see, 3) Talking about feelings, 4) Praising and rewarding our children, 5) Giving positive, specific, and realistic instructions, 6) Establishing household rules and routines, 7) Redirecting negative behavior, 8) Ignoring negative attention seeking and demanding behavior, 9) Using consequences to support compliance, 10) Using Cool-down as a consequence for aggressive behavior, 11) Avoiding and resolving conflicts, 12) Reflection celebration, and moving on.
15912847|NCT03552237|Dietary Supplement|dietary fiber|We will investigate in a 4 week intervention whether consumption of dietary fiber supplement affect the microbiota composition in schizophrenia patients with central obesity.
15912848|NCT03552224|Procedure|Recording of auditory nerve activity|near field recording of auditory nerve activity with contact electrode
15912849|NCT03552211|Drug|biotin|This is a national, academic, observational and retrospective study comparing one group of progressive MS patients with high dose biotin to another group without this treatment using a propensity score, in intention to treat.
15912850|NCT03552211|Other|propensity score|This is a national, academic, observational and retrospective study comparing one group of progressive MS patients with high dose biotin to another group without this treatment using a propensity score, in intention to treat.
15912852|NCT03552172|Other|Physical activity|PHYSICAL ACTIVITY: Rhythm of meetings, number of meetings, place of meetings
15912853|NCT03552172|Other|Absence of or suspended physical activity|the brakes responsible for a stop or lack of practice
15912854|NCT03552159|Behavioral|Behavioral activation|Activity scheduling, monitoring, review and re-scheduling
15912855|NCT03552159|Other|Psychoeducation|Education on dementia, caregiving stress, event scheduling and communication skills
15912856|NCT03552146|Drug|Propofol|Patients will be randomized to either propofol or dexmedetomidine and then observed for sedation-related events from time of drug administration to discharge.
15912857|NCT03552146|Drug|Dexmedetomidine|Patients will be randomized to either propofol or dexmedetomidine and then observed for sedation-related events from time of drug administration to discharge.
15912858|NCT03552133|Device|Smart CO2|A lightweight, cylindrical reservoir attached to a face mask which monitors breathing breath-by-breath and automatically adjusts the level of dead space rebreathe volume so that CO2 will be increased and sleep apnea treated.
15912859|NCT03552120|Behavioral|Mindfulness-Oriented Recovery Enhancement|MORE is a manualized integrative treatment strategy that targets transdiagnostic mechanisms in stress-related conditions. MORE is made up of three primary components: mindfulness training, cognitive restructuring, and savoring. Mindfulness training aims to increase attentional control to reduce cognitive bias toward negative information. Cognitive reappraisal promotes restructuring of maladaptive cognitions, which would otherwise intensify negative emotion and addictive behavior. Finally, MORE promotes savoring - mindful attention to and appreciation of pleasant events in life as a means of increasing positive emotion regulation.
15912860|NCT03552120|Behavioral|Supportive Psychotherapy|Supportive psychotherapy is a form of non-directive talk therapy, which follows a Rogerian person-centered approach. The therapist's primary objectives during a session will be (1) to communicate unconditional positive regard for the participant, (2) to communicate engagement and empathic understanding, and (3) to mirror a participant's affect.
15912861|NCT03552107|Drug|Lorcaserin|Treatment initiation with Lorcaserin
15912862|NCT03552094|Other|Blood donations of hemochromatosis or polycythemia patients|Blood samples are from blood donations of hemochromatosis or polycythemia patients requiring therapeutic bleeding that are not used in medical applications.
15912863|NCT03552094|Other|Blood donations of healthy donors|Blood samples are from blood donations of healthy donors.
15912864|NCT03552081|Other|Fragmented DNA evaluation in blood and semen samples|The objective will be to evaluate the decrease in the percentage of sperm with spermatic DNA fragmentation by the TUNEL technique following the evolution of this rate to 3 months, 6 months and 12 months after cessation of smoking by blood and semen samples.
15912865|NCT03552068|Drug|placebo|"Treatment (placebo) will be taken during 8 weeks with one visit at 2, 4 and 8 weeks.
~Medication: placebo twice a day (in the morning and evening)."
15912987|NCT03551067|Drug|Dexmedetomidine|Dexmedetomidine mixed with juice was given to the child orally preoperatively.
15912866|NCT03552068|Drug|Clonidine|Treatment will be taken during 8 weeks with one visit at 2, 4 and 8 weeks. Medication: 75 μg of clonidine twice a day (in the morning and evening).
15912867|NCT03552055|Other|Non-interventional Study|no interventions in this study, just specimen collection
15912868|NCT03552042|Behavioral|Counterclockwise program|A group of older adults (aged 75+) will take part of a residential role-play game, in which they will relive their previous self, acting as if they were in the year 1989. The whole residential program, which will last one week, is designed to enhance this perception, including a retrofitted environment and social activities that will prime participants to relive that period.
15912869|NCT03552042|Behavioral|Active control group|Participants in the active control group will follow the same agenda of the Counterclockwise Program group, without the constant reference to 1989. The intervention will take place in the same location of the Counterclockwise Program, without any specific change. Activities will mirror the ones of Counterclockwise Program, but participants will not live as if they were younger. The agenda will be the same, but no mention to 1989 will be done. All discussion activities will refer to present days (e.g., instead of discussing the open of the Berlin Wall, they can discuss Brexit or Trump presidency).
15912870|NCT03552029|Drug|Quizartinib|20 or 30 mg tablets for oral administration
15912871|NCT03552029|Drug|Milademetan|5, 20, 80 or 200 mg capsules for oral administration
15912872|NCT03552029|Drug|Milademetan|5, 20, 80 or 200 mg capsules for oral administration; 30, 45, 80, or 100 mg capsules may be utilized
15912873|NCT03552016|Drug|Oral Riboflavin|The intervention doses will be 200 mg oral riboflavin and 400 mg oral riboflavin doses; the placebo dose will be 0 mg of oral riboflavin
15912874|NCT03552003|Other|Treatment for clinical practise|Prospective data collection with the aim to to develop a prognostic index for elderly patients with newly diagnosed cHL
15912875|NCT03551990|Procedure|whole-body electromyostimulation WB-EMS|Patients of the WB-EMS group will perform whole-body electromyostimulation (WB-EMS) training sessions twice a week over a period of 8 weeks. To allow muscle recovery a break of at least 2 days between the sessions will be scheduled. To adapt the patients to the WB-EMS intervention, the training duration will be gradually increased (week 1, 12 min; increase of 2 min/week; week 5-8, 20 min). WB-EMS training sessions will include light physical exercises according to a video tutorial and individually supervised by certified physio therapists.
15912876|NCT03551977|Behavioral|iCanCope with Pain|The participants are free to use the Norwegian iCanCope with Pain app as much as they want during the 8 week intervention period. The only support available is technical support.
15912877|NCT03551977|Behavioral|iCanCope with Pain control|The participants are free to use the Norwegian iCanCope with Pain control app as much as they want during the 8 week intervention period. The only support available is technical support.
15912878|NCT03551964|Drug|Cangrelor|"Cangrelor: IV bolus 30 μg/kg (application < 1 minute), immediately followed by continuous infusion in the dose of 4 μg/kg/min. To accelerate the initiation of therapy, tables containing calculations of the bolus dose in ml and the speed of infusion therapy for individual weights will be prepared.
~Cangrelor therapy will be stopped after circulatory stabilization - when sBP > 100 mmHg persists for one hour / when IABP will be terminated / when vasoactive treatment with norepinephrine, dopamine (in the dose ≥ 5 μg/kg/min) will be stopped, but not later than 4 hours after PCI
~30 minutes before stopping Cangrelor infusion, administration of initial dose of crushed Ticagrelor 180 mg and then Ticagrelor maintenance dose 90 mg twice a day for 12 months."
15912879|NCT03551964|Drug|Ticagrelor|Initial dose crushed Ticagrelor 180 mg. Maintenance dose Ticagrelor 90 mg twice daily for 12 months.
15912880|NCT03551951|Diagnostic Test|Test for circulating tumor cells, DNA alterations|
15912881|NCT03551938|Behavioral|Relationship skills session for YMSM partnered-individuals and couples|Relationship skills session as an addition to the current CTR and CHTC intervention for 15-24 year old YMSM and their partners.
15912882|NCT03551925|Behavioral|Treatment as Usual Plus Occupational Therapy|The IMeds consists of a three-step process that leads the client from the reflection of past performance, to goal setting, and onto strategy identification and implementation. This intervention guides the client through identifying strategies in the following six areas: altering the medication management activity, advocacy, assistive technology, environmental modifications, and securing refills on time (Schwartz et al., 2017).
15912883|NCT03551925|Behavioral|Treatment as Usual|A clinical pharmacist counsels participants on proper medication adherence.
15912884|NCT03551912|Procedure|Surgery|All patients coming for elective surgery
15912885|NCT03551899|Other|Different ventilation parameters|mode of ventilation, tidal volume per body weight and PEEP settings
15912886|NCT03551886|Behavioral|Advanced Emotion App|The app is designed to help TAY better recognize their emotions using enhanced features
15912887|NCT03551886|Behavioral|Basic Emotion App|The app is designed to help TAY better recognize their emotions using basic features
15912888|NCT03551873|Drug|Plecanatide|Subjects will have been breastfeeding or pumping for at least 4 weeks and must have been prescribed and taking TRULANCE® for at least 14 continuous days prior to Baseline. Breast milk for measurement of TRULANCE® (plecanatide) concentrations will be collected at Day 1.
15912889|NCT03551860|Procedure|TQL|"For the intervention of TQL peripheral nerve block the needle tip will be advanced by in-plane technique and local anaesthetic will be deposited between psoas major and quadratus lumborum muscles. 20 ml of 0.25% bupivacaine will be administered under ultrasound guidance following careful intermittent aspiration. The needle tip will not be repositioned unless the patient complains of paraesthesia.
~For the intervention of spinal neuraxial blockade the needle will be advanced into the subarachnoid space. Once clear CSF is visualised 3.2ml 0.5% plain bupivacaine will be infiltrated."
15912890|NCT03551860|Procedure|FIB|"The needle tip will be advanced by in-plane technique and local anaesthetic will be deposited deep to the fascia iliaca. 20ml of 0.25% bupivacaine will be administered under ultrasound guidance following careful intermittent aspiration. The needle tip will not be repositioned unless the patient complains of paraesthesia.
~For the intervention of spinal neuraxial blockade the needle will be advanced into the subarachnoid space. Once clear CSF is visualised 3.2ml 0.5% plain bupivacaine will be infiltrated."
15912891|NCT03551847|Drug|Antibiotic|The intervention involves giving an infected patient antibiotics.
15912892|NCT03551847|Drug|No antibiotics|The intervention involves not giving an infected patient antibiotics.
15912893|NCT03551834|Other|Conventional scleral patch graft glaucoma implantation|conventional AGV implantation by using scleral patch graft to cover the tube and prevent tube exposure
15912894|NCT03551834|Other|New surgical method (short tunnel small flap technique)|a novel technique named short tunnel small flap (STSF) by tunneling the sclera to pass the AGV tube without using scleral patch graft.
15912895|NCT03551821|Drug|ATI-50002|Topical Solution
15912896|NCT03551808|Drug|using of Ketorolac Tromethamine Eye Drop|using of Ketorolac Tromethamine Eye Drop one day before the surgery in each 8 hours and continue it for 4 weeks after the surgery
15912897|NCT03551795|Biological|Infusion of iNKT cells|The eligible patients receive twice infusions of iNKT cells(1E8~1E10) in one course of treatment.
15912898|NCT03551782|Drug|Cetrelimab 480 mg|Cetrelimab 480 mg will be administered intravenously (IV) on Cycle 1 Day 1, then every 4 weeks thereafter (Q4W).
15912899|NCT03551782|Drug|Apalutamide 240 mg|Apalutamide 240 mg (4*60 mg) tablets per day will be administered orally.
15912900|NCT03551769|Drug|tricaprilin|Tricaprilin formulated as AC-SD-01
15912901|NCT03551769|Other|standard meal|standard meal
15912902|NCT03551769|Other|high-fat meal|high-fat meal
15912903|NCT03551769|Other|overnight fast|fasting for at least 9 hours
15912904|NCT03551756|Other|Biomarker Assessment|Exploratory Biomarker Analysis for cardiac patients versus healthy adults
15912905|NCT03551743|Combination Product|PRT064445/Edoxaban|
15912906|NCT03551743|Combination Product|Placebo/Edoxaban|
15912907|NCT03551743|Drug|Placebo|
15912908|NCT03551730|Combination Product|PRT064445/Enoxaparin|
15912909|NCT03551730|Combination Product|Placebo/Enoxaparin|
15912910|NCT03551730|Drug|Placebo|
15912911|NCT03551717|Other|Optical Coherence Tomography angiography|At the inclusion visit for all patients and at M3 only for 50 patients.
15912912|NCT03551717|Other|Fundus|At the inclusion visit for all patients and at M3 only for 50 patients.
15912913|NCT03551717|Other|cardiac ultrasound scan|Only for 50 patients, 3 months after the initial cardiovascular event
15912914|NCT03551704|Behavioral|CBT + EFT|"The CBT treatment will be implemented in 8-week group-based sessions (maximum 4 patients). Sessions will be carried out once a week over an 8-week period, with quit date occurring at fifth session. Patients will be asked to gradually reduce their nicotine intake (i.e., 25% each week). CBT components include: psychoeducation, self-monitoring, physiological feedback, training in stimulus control and strategies for controlling negative discomfort, and relapse prevention strategies.
~As part of the EFT, participants will be asked to select future smoking-related events that would occur within the following time periods: 2 weeks, 1, and 6 months. They will be instructed to generate personal audio recordings that will be used to help them think about future decision-making choices."
15912915|NCT03551704|Behavioral|CBT + EFT + CM|This intervention includes the abovementioned treatment components and a CM procedure reinforcing abstinence. This arm will consist on delivering CBT and EFT and providing patients incentives to promote and reinforce abstinence contingent on abstinence. The schedule will incorporate an increasing magnitude of reinforcement.
15912916|NCT03551691|Drug|Omeprazole 40mg Capsule|Omeprazole 40mg daily for 28 days
15912917|NCT03551691|Drug|Placebo oral capsule|Identically-appearing capsule to omeprazole
15912918|NCT03551678|Device|Active feedback gait retraining|The device measures pressure/force under the lateral side of the foot and activates vibration if loading crosses a set threshold. The location of the vibration is customized for each subject to achieve maximal sensitivity.
15912919|NCT03551665|Behavioral|Protective step training|Participants will undergo 2 weeks of training, in which they will be exposed to repeated slips on a treadmill. This approach is aimed at improving protective steps.
15912920|NCT03551652|Drug|Pharmacokinetics of rocuronium induced neuromuscular block|Measurement of rocuronium induced neuromuscular block comparing patients aged > 80 years with patients aged 18 to 50 years
15912921|NCT03551626|Drug|Dabrafenib|Supplied as dabrafenib 50 mg, 75 mg Capsules for oral use
15912922|NCT03551626|Drug|Trametinib|supplied as trametinib 0.5mg, 2.0mg tablets for oral use
15912923|NCT03551613|Dietary Supplement|honey supplementation|honey supplementation
15912924|NCT03551600|Procedure|Near-infrared spectroscopy (NIRS)|NIRS analyzes regional oxygen saturations (rSO2)
15912925|NCT03551587|Device|Vibringe|The Vibringe is the first endodontic sonic irrigation system that enables delivery and activation of the irrigation solution in the root canal, in only one step.
15912926|NCT03551561|Drug|CSAAC|Skin preparation with 4% chlorhexidine-based soap for a period of 5 minutes, followed by a sterile and soaked with 70% alcohol compress. After removing the chlorhexidine-based soap excess, antisepsis was performed with alcoholic chlorhexidine and surgical drapes and gowns.
15912927|NCT03551561|Drug|CSAC|Skin preparation with 4% chlorhexidine-based soap for a period of 5 minutes and the of a simple, dry and sterile compress to remove the excess. After removing the excess, antisepsis was performed with alcoholic chlorhexidine and surgical drapes and gowns.
15912928|NCT03551548|Drug|Spironolactone 25mg|25 mg oral spironolactone once daily on top of standard therapy, started 14 ± 4 days before cardiac surgery and continued during 30 days after surgery.
15912929|NCT03551548|Drug|Placebo oral capsule|oral placebo once daily on top of standard therapy, started 14 ± 4 days before cardiac surgery and continued during 30 days after surgery.
15912930|NCT03551535|Behavioral|Monitored, At-Home Exercise Intervention|Patients will be enrolled in the BurnAlong program as well as receive FitBit heart rate + activity monitors to track adherence rates to the prescribed exercise regimen on BurnAlong, with subsequent motivational interventions triggered if compliance varies from prescription
15912931|NCT03551522|Drug|Seladelpar|10 mg, 20 mg, or 50 mg
15912932|NCT03551522|Drug|Placebos|Matching placebo Capsule
15912933|NCT03551509|Biological|ArthroFLEX ECM scaffold graft|In patients receiving a graft, thru mini open technique the lateral portal incision will be extended vertically approximately 5-6 cm. A standard, deltoid-splitting, mini-open approach will then be performed, leaving the deltoid attachment to the acromion intact. For arthroscopic technique same method of fixation will be used below. The dermis graft will be sized and cut so as to cover the entire repair site in both medial-lateral and anterior-posterior dimensions.
15912934|NCT03551509|Procedure|Control|This group will undergo rotator cuff repair surgery, but will not receive the ECM scaffold graft.
15912935|NCT03551509|Biological|Crossover|Patients randomized to the control arm who cannot be repaired without an augmented graft will be followed for safety and remain in the study and put into a group for the intention to treat.
15912936|NCT03551496|Combination Product|Drug Eluting Stent - Below the Knee|Treatment arm with DES-BTK, starting with one size of the device - 3.5 mm X 80 mm
15912937|NCT03551496|Device|Standard PTA Control Arm|The PTA device used must be market-released in the investigational center's geography and the size (ie, diameter, balloon length and catheter length) will be determined by the investigator.
15912938|NCT03551483|Device|ArtontheBrain|The ArtontheBrain intervention has three activities focused on a user selected artwork. The activities promote an in-depth analysis of the artwork and are organized into three activity categories; learn, play, and mingle. In 'learn', the options are to read and/or listen to the curatorial description of the artwork. In 'play', the options are to engage in a word search game, to engage in a visual puzzle game, or to engage in a storytelling game whereby a reminiscence or imaged story can be written. In 'mingle' the options involve social communications about the artwork that include seeing what other comments and seeing how the artwork has been rated by others. The mingle option permits the user to engage only with a select circle of users or to engage with a group of public users.
15912939|NCT03551483|Device|Seniors Online Victoria|The active control group will use a freely available website, which is updated daily with online games for seniors through an organization called Seniors Online Victoria (https://www.seniorsonline.vic.gov.au/services-information/games).
15912940|NCT03551470|Procedure|Robotic one-stage colorectal and liver resection|
15912941|NCT03551457|Diagnostic Test|Biopsy|Patient-derived xenograft treatment response phenotype.
15912942|NCT03551444|Drug|Administration of DAA-based treatment|"Antiviral therapy and treatment duration (12/24 weeks) will be indicated in each patient according to the viral genotype/subtype and the severity of liver disease, in accordance with the EASL Recommendations on Treatment of Hepatitis C 2016.
~HCV-RNA quantification will be assessed by real-time PCR, with a limit of detection (LOD) of15 IU/mL.
~During antiviral treatment, follow-up of the Patients will be monthly by clinical and laboratory evaluation.
~Virological response to DAA-based treatment will be assessed by quantitative HCV-RNA at the end of treatment (EOT) and at 4 and 12 weeks after the EOT, to confirm sustained virological response (SVR).
~SVR12 is defined as undetectable HCV-RNA at week 12 after the EOT.
~Virological failures and early discontinuations of therapy due to adverse events will be also registered."
15912943|NCT03551431|Diagnostic Test|Video EEG with verbal suggestion|Video EEG with verbal suggestion will be done by attaching EEG electrodes to the child along with verbals suggestion in isolation or verbal suggestion and tuning fork, verbal suggestion and cotton swab.
15912944|NCT03551418|Behavioral|Watching a video|Watching a video of an adult with DS washing his hands
15912945|NCT03551405|Radiation|CBCT scan|CBCT is a standard image guidance procedure for patient setup in image-guided radiation therapy at the Department of Radiation Oncology, UTSW. Our study will deliver three additional CBCT scans to each patient in only one fraction. These additional scans will increase radiation doses to the patients, which elevate the radiation-associated risks of secondary cancer.The other risk involved in this study is a possible violation of patient confidentiality. The imaging data will be completely anonymized, since the patient related information is not needed for this study.
15912946|NCT03551392|Device|Medx Console System|This intervention delivers near infrared (NIR) light using light emitting diodes applied to the head and via an intranasal applicator for a period of approximately 1.5 hours. A total of 16 sessions take place in the lab over 12 weeks.
15912947|NCT03551392|Device|Sham Medx Console System|This intervention uses sham application of near infrared light (NIR) using light emitting diodes applied to the head and via an intranasal applicator for a period of approximately 1.5 hours. A total of 16 sessions take place in the lab over 12 weeks.
15912948|NCT03551392|Device|Vielight 810 intranasal stand alone unit|Daily at home intranasal NIR stimulation sessions, 25 minutes in duration, 4 days each week.
15912949|NCT03551392|Device|Sham Vielight 810 intranasal stand alone unit|"Daily at home intranasal sham NIR stimulation sessions, 25 minutes in duration, 4 days each week."
15912950|NCT03551379|Device|Double Balloon Endoluminal Platform|A DBA platform will be use din this registry study to facilitate ESD
15912951|NCT03551366|Behavioral|Linear|The linear pedagogy arms consists of three, five-week phases of lesson delivery, commencing around two weeks after baseline assessments. The first phase focuses on dance, the second on gymnastics and the final phase on ball sports. Each phase has its own schemes of work which includes five lessons objectives, each taught over a two lesson period. The lesson objectives aligned to the aims of English national curriculum. Lessons are delivered twice a week by trained coaches, with each lesson lasting 60 minutes in total, with 45 minutes of on task teaching time. Linear curriculum lessons will be focused on the functioning of the body and children learning movement patterns. These lessons will be far more prescriptive and have clearly stated outcomes/goals for each lesson, with a typical lesson structure following the structure of warm up, isolated practice of technique or skill, simulated game and warm down.
15912952|NCT03551366|Behavioral|Nonlinear|The non-linear pedagogy arm consists of three, five-week phases of lesson delivery, commencing around two weeks after baseline assessments. The first phase focuses on dance, the second on gymnastics and the final phase on ball sports. Each phase has its own schemes of work which includes five lessons objectives, each taught over a two lesson period. The lesson objectives align to the aims of English national curriculum. Lessons are delivered twice a week by trained coaches, with each lesson lasting 60 minutes in total, with 45 minutes of on task teaching time. The nonlinear curriculum lessons will look to make sure that children are both engaged and empowered throughout the learning process. In adherence to representative learning design, we will look to contextualise lessons and guide learning through the use of books/stories, lived experiences and the sharing of ideas.
15912953|NCT03551353|Other|Group before Video-assisted feedback|Ten anesthesia residents will be included in this group. Preoperative evaluation in terms of general anesthesia will be completed for a patient before anesthesia induction. After receiving informed consent from the patient resident will complete the preparations by checking the above-mentioned list (anesthesia machine, operating room desk, monitorization methods, aspirator systems, operating room gas systems, waste systems and other anesthesia equipment) then induction will be started. All these steps will be recorded with a camera system. Once the anesthetic application is completed and all stages are recorded, the video records will be evaluated in terms of ASA guideline
15912954|NCT03551353|Other|Group after Video-assisted feedback|Before the second phase of the study, the resident will be informed about the guideline (checkout procedure) by a staff. Then induction of general anesthesia in another patient will be recorded at all stages. Once the anesthesia application is complete, the camera record will be monitored. Differences and developments or possible similar mistakes between the records will be discussed.
15912955|NCT03551340|Diagnostic Test|Gastro-intestinal panel by PCR|The study will evaluate the change in medical management with the replacement of traditional stool investigations (microscopy and culture) by the new gastrointestinal multiplex PCR panels
15912956|NCT03551327|Behavioral|Experimental: Intervention plus information|The intervention will include six sessions with a therapist, each separated by two weeks. During the two weeks between sessions, participants will work on the goals identified during the sessions. At the final session, the participants will agree how to maintain any improvements in fatigue. Then there will be a review phone call about 4-6 weeks after completion of the intervention, to check on progress and to offer ongoing encouragement to continue with the changes that have been made during the intervention. The intervention can be delivered by video conferencing as well as by phone.
15912957|NCT03551327|Other|Active Comparator: Information only|Participants in this arm will be provided with information about fatigue.
15912958|NCT03551314|Other|Nasal Intermittent Positive Pressure|"- NIPPV The following parameters: inspiratory pressure = 15 cmH2O / final expiratory positive pressure = 6 cmH2O / inspiratory time = 0.40 / flow = 6-8 L.min-1 / respiratory rate = 24.
~Respiratory inductive plethysmography is used to evaluate breathing pattern (tidal volume, respiratory rate, minute ventilation, mean inspiratory flow) and chest wall motion (labor breathing index - LBI, phase relation in inspiratory breathing - PhRIB, phase relation in expiratory breathing - PhREB, total phase relation - PhRTB and phase angle)."
15912959|NCT03551314|Other|Continuous Positive Airway Pressure|"- CPAP The following parameters: pressure of 6 cmH2O, with flow of 6-8L/min.
~Respiratory inductive plethysmography is used to evaluate breathing pattern (tidal volume, respiratory rate, minute ventilation, mean inspiratory flow) and chest wall motion (labor breathing index - LBI, phase relation in inspiratory breathing - PhRIB, phase relation in expiratory breathing - PhREB, total phase relation - PhRTB and phase angle)."
15912960|NCT03551301|Other|Transitional Case Management|"TCM program is a type of very flexible community treatment in terms of frequency and intensity of care. This is facilitated by a small case load ratio per health care professional (1:10). The healthcare workers are specialised in SUD treatment. The intervention begins during hospitalisation and lasts around 4 weeks after discharge from the hospital.
~The main aim of this intervention is to accompany the patient in the difficult phase of transition between hospital and outpatient care and ensure their adherence to the treatment program. The healthcare workers will explore specific patient needs and ensure that health and social services are better coordinated to fit their needs. Another important aim is to reduce the number of (unplanned) hospitalizations and emergency room visits."
15912961|NCT03551288|Drug|SUVN-911|Tablet
15912962|NCT03551275|Biological|BCD-132|Dose Escalation Study
15912963|NCT03551262|Device|OTSC|Positioning of OTSC in bleeding peptic ulcer
15912964|NCT03551262|Device|TTS clip|Positioning of TTS clip in bleeding peptic ulcer
15912965|NCT03551249|Device|Focused ultrasound (FUS)|FUS involves the application of acoustic energy at low frequencies from over 1000 individual transducers into distinct body targets.
15912966|NCT03551223|Biological|Neuron specific enolase (NSE)|5 cc of venous blood will be drawn from all of the participants and be examined for NSE and S100 B serum levels in order to evaluate evaluate which anesthetic method (general anesthesia versus spinal anesthesia) is associated with reduced neuronal injury in a preeclamptic parturients undergoing a cesarean section.
15912967|NCT03551210|Drug|Nemonoxacin|Solution for infusion, 500 mg (250 ml)
15912968|NCT03551210|Drug|Nemonoxacin|Capsules, 250 mg
15912969|NCT03551210|Drug|Tavanic|Solution for infusion, 500 mg (100 ml)
15912970|NCT03551210|Drug|Tavanic|Film coated tablets (each tablet is placed into a capsule shell (overencapsulated) for blinding purposes), 250 mg
15912971|NCT03551210|Drug|Placebo (250 ml)|0.9% NaCl (250 ml), solution for infusion
15912972|NCT03551210|Drug|Placebo (100 ml)|0.9% NaCl (100 ml), solution for infusion
15912973|NCT03551197|Drug|Budesonide and formoterol bid|At baseline,lung function test,blood oxygen saturation and pulse are measured before and after 6-min walk test for each subject.Quality of life is assessed through questionnaires including modified Medical Research Council dyspnoea scale(mMRC),St George's Respiratory Questionnaire(SGRQ),clinical chronic obstructive pulmonary questionnaire(CCQ) and chronic obstructive pulmonary disease assessment test(CAT).And then budesonide(160ug) and formoterol(4.5ug) bid will be given to the subjects for 3 months.The subjects will have a follow-up visit with all the examinations mentioned above after 3 months' treatment.
15912974|NCT03551184|Biological|Endotoxin|Endotoxin at 0.6 ng/kg of body weight administered intravenously (Escherichia Coli, Lot nr G3E0609, United States Pharmacopeia Rockville, MD)
15912975|NCT03551184|Biological|Placebo|Saline administered intravenously
15912976|NCT03551171|Drug|ZL-2306 (niraparib)|"About 30 subjects will be enrolled to the study, and randomised into 300mg, 200mg and 100mg dose groups (about 10 subjects per group).
~All subjects will be randomised into indicated dose group (300mg, 200mg or 100mg) at the first day of the first cycle. A single administration of ZL-2306 (niraparib) will be given to the subjects at indicated dose."
15912977|NCT03551158|Diagnostic Test|Echocardiography|Cardiac imaging for the assessment of the left atrium anatomy and function.
15912978|NCT03551145|Other|Acellular collagen matrix|3D collagen matrix consists of the collagen porcine type I and III
15912979|NCT03551145|Other|Autogenous free gingival graft|Autogenous graft harvested from the posterior palate
15912980|NCT03551132|Other|Exercise test|Fat mass, Functional autonomy, muscular strength, quality of life questionnaire
15912981|NCT03551119|Behavioral|Exercise|See previous description
15912982|NCT03551119|Other|Enhanced usual care|See previous description
15912983|NCT03551106|Other|Web based learning module|Web based learning module available on a especially designed website
15912984|NCT03551093|Device|ISS SPG stimulation|The ISS is intended to deliver electrical stimulation to the nerves within the greater palatine canal and pterygopalatine fossa (SPG).
15912985|NCT03551080|Biological|Lipopolysaccharide|Endotoxin at 0.8 ng/kg of body weight administered intravenously (Escherichia Coli, Lot nr G3E0609, United States Pharmacopeia Rockville, MD)
15912988|NCT03551067|Combination Product|Midazolam/Ketamine|Midazolam/Ketamine was mixed with juice and given to the child orally preoperatively
15912989|NCT03551054|Behavioral|Healthy for Two, Healthy for You|Remotely delivered health coaching in pregnancy and postpartum to promote healthy weight gain.
15912990|NCT03551054|Behavioral|Health Education|
15912991|NCT03551028|Device|HPV self collection|The proposed community based participatory study aims to determine whether offering self-collection for HPV testing through the mobile mammography unit is an acceptable and feasible method to increase access to cervical cancer screening for under-screened women in Southwest Virginia.
15912992|NCT03551015|Other|Change in the timing of components of usual care|Bringing forward outpatient review, and cardiac rehabilitation after CABG by 3 and 4 weeks respectively.
15912993|NCT03550989|Other|Non-Exposure Event|Non-Exposure event of 4h duration for the individual participants, where no use of any tobacco or nicotine-containing product is allowed, designed to establish background measurements in the absence of exposure to IQOS.
15912994|NCT03550989|Other|Exposure Event|Exposure Event designed to measure urinary BoExp to selected HPHCs representative of ETS in all participant groups, with up to 5h of exposure to IQOS tobacco environmental aerosol for non-smokers, cigarette smokers (not using any tobacco or nicotine-containing product, including cigarettes), and IQOS passive users (not using IQOS). Additionally, this event includes up to 8h of exposure for IQOS active users (using IQOS).
15912995|NCT03550976|Behavioral|The low-GI diet and muscle training|During the 12-28 weeks of pregnancy, the pregnant women received low-GI diet and exercise intervention.Every two weeks, the pregnant women were followed up to assess the dietary situation and analyze the body composition results.Collect birth outcomes
15912996|NCT03550963|Other|rice-richen meal|Participants in group one will be provided with rice-richen meal. All participants will be required to test and record blood glucose.
15912997|NCT03550963|Other|wheaten-richen meal|Participants in group two will be provided with wheaten-richen meal.All participants will be required to test and record blood glucose.
15912998|NCT03550950|Drug|JNJ-64232025 IV|JNJ-64232025 will be administered as IV infusion.
15912999|NCT03550950|Drug|JNJ-64232025 SC|JNJ-64232025 will be administered as SC injection.
15913000|NCT03550950|Drug|Placebo|Matching placebo will be administered as IV infusion or SC injection.
15913001|NCT03550924|Procedure|low flow passive oxygenation|low flow passive oxygenation during laryngoscopy with 10l/min oxygen via standard nasal prongs
15913002|NCT03550924|Procedure|high flow passive oxygenation|high flow passive oxygenation during laryngoscopy with 120l/min oxygen via THRIVE system
15913003|NCT03550911|Other|Biological Collection From Samples From The Gut Microbiota|The aim of this study is just to constitute a biological collection from samples from the Gut microbiota in patients having a bone or joint infection treated by a suppressive subcutaneous antibiotherapy with betalactamine. No analysis will be done for instance.
15913004|NCT03550898|Diagnostic Test|Dynamic Ultrasonography|Dynamic Ultrasonography was performed with patients in supine position, with a suprapubic sagittal position transductor, during filling phase of urodynamics.
15913005|NCT03550885|Other|High taurine and saturated fat diet|This is a 3-week (21 day) isocaloric Western-type diet with all meals, snacks, beverages and condiments provided.
15913006|NCT03550885|Other|Low in taurine and saturated fat diet|This is a 3-week (21 day) isocaloric largely plant-based diet with all meals, snacks, beverages and condiments provided.
15913007|NCT03550872|Behavioral|Physical Training|Participants will perform physical training three times a week on a stationary bicycle. The exercise intensity will be controlled between 14 and 16 by the Borg Scale for 40 minutes
15913008|NCT03550859|Drug|Telmisartan/Rosuvastatin 40/10mg|Telmisartan/Rosuvastatin 40/10mg qd for 48 weeks
15913009|NCT03550859|Drug|Telmisartan 40mg|Telmisartan 40mg qd for 48 weeks
15913010|NCT03550833|Behavioral|Questionnaire|Questionnaire
15913011|NCT03550833|Biological|blood sample|7 ml whole blood for Peripheral blood
15913012|NCT03550794|Drug|Thiamine Hydrochloride|Thiamine hydrochloride is a water soluble vitamin (vitamin B1). 200mg of thiamine hydrochloride in 50ml 0.9%NACL will be administered twice daily for 3 days.
15913013|NCT03550794|Drug|Placebo|50ml of 0.9% NACL will serve as the placebo
15913014|NCT03550781|Drug|Prednisone, cyclophosphamide|Prednisone 0.5mg/(kg•d) and/or cyclophosphamide 2mg/kg
15913015|NCT03550768|Other|MDP|evaluate the anatomy of each major duodenal papilla before selective cannulation during ERCP
15913016|NCT03550755|Biological|V3-Cervix|Oral tableted preparation containing hydrolyzed tumor antigens derived from peripheral blood and tumor tissue
15913017|NCT03550742|Other|Fuco-N-Tetraose|Daily bolus of Fuco-N-Tetraose
15913018|NCT03550729|Behavioral|Endurance training|Endurance training 3 times per week during 3 months using interval training above 70% of load peak reached in the incremental exercise test. The duration of the sessions will be adapted individually to each patient (approximately 60 minutes).
15913019|NCT03550716|Procedure|mTESE|mTESE is performed according to the initial description by Schlegel (4). General anesthesia is used. Midline incision of the scrotum is made and carried down to the level of the tunica vaginalis, which is opened to deliver the testis. Equatorial incision is made and the testis bivalved. The operating microscope is used to identify plump-appearing seminiferous tubules, and biopsies are taken from these areas. These samples are examined by an embryologist in the operating room after initial gross dispersion by passing the tissue through a 24G angiocatheter. The procedure is stopped if spermatozoa are found. If no plump tubules are found, random biopsies targeting every area of the testis are taken. If necessary the procedure is carried out on the contralateral testis. Hemostasis is obtained with careful bipolar cautery, and the tunica albuginea and the tunica vaginalis are closed with a running 4-0 Vicryl. Standard scrotal closure is performed and gentle pressure dressing is applied.
15913020|NCT03550716|Procedure|TESA|In general anesthesia an 18 gauge needle is introduced into each testis, and negative pressure applied with a 10 ml syringe. Multiple passes throughout the entire testis, numbering 50-100 passes, are made through a single percutaneous/tunical entry and continued until tissue is visible in the hub of the needle. This is removed by brisk extraction of the needle and pressure held to tamponade bleeding. The aspirated tissue is examined by an embryologist in the operating room after initial gross dispersion by passing the tissue through a 24 gauge angiocatheter.
15913021|NCT03550703|Biological|V3-Myoma|Once daily oral pill of V3-Myoma
15944099|NCT03310021|Drug|Apixaban|factor Xa inhibitor
15913022|NCT03550690|Device|Large Volume Paracentesis|Insertion of a plastic tube into the abdomen and draining off ascitic fluid under local anaesthetic, removing the drain afterwards
15913023|NCT03550690|Device|Rocket Indwelling Pleural Catheter|A small plastic tube under the skin which is left in place so that the fluid can be drained if it builds up again
15913024|NCT03550677|Procedure|general anesthesia|The patient will be monitored with ECG, pulse oximetry and noninvasive blood pressure. Anesthesia will be induced using 2-2.5 mg/kg propofol, 1-2 mcg/kg fentanyl, 10-20 mg rocuronium and proper size Laryngeal mask airway will be placed securely the airway.
15913025|NCT03550677|Procedure|ankle block|ankle nerve block will be performed in group ankle block patients using a mixture of 5 ml of 2% lidocaine and 10 ml of 0.5% bupivacaine and same amount placebo (saline) in groups placebo under the guidance of peripheral nerve stimulator the anesthesia will be discontinued and LMA will be removed. The patients will be transferred from postoperative care unit to the ward after they are eligible for discharge according to modified Aldrete scoring system.
15913026|NCT03550664|Device|Monitoring of neuromuscular transmission|Monitoring of neuromuscular transmission will be done by TOFScan (IdMed, Marseille, France). This device is CE marked, and is used routinely in daily clinical practice. Prior to induction of anesthesia, the TOFScan is placed on a patient's hand and the two stimulation electrodes (ECG electrodes) are placed at the level of the ulnar nerve at the wrist. After induction of anesthesia and before administration of a curare, the TOFScan is calibrated according to the manufacturer's instructions. The TOFScan is placed in automatic mode, it will then automatically adapt its mode of stimulation to the depth of the curarization. The TOFScan measurements will be recorded on a PC connected to the TOFScan.
15913027|NCT03550651|Other|Licorice|Licorice, since years is known for its anti-inflammatory, antimicrobial, antiviral, antiprotozoal, antioxidative, hepatoprotective, cardioprotective, immunomodulatory and antitumour activity. Licorice can be beneficial for oral health. Glycyrrhizin, the sweet component of licorice root has antiplaque property. Pterocarpenes isolated from G. uralensis root extract exerts an antibacterial activity against Streptococcus mutans.
15913028|NCT03550651|Other|Hypertonic salt solution|The antiseptic and bactericidal qualities of salt help in removing plaque which is a cause of gingivitis and caries. Warming water with a pinch of table salt can reduce or even be an alternative to anti-inflammatory drugs intra-orally. Its high osmolality reduces inflammation and can be microbicidal. Moreover, efficacy of luke warm hypertonic salt solution has shown antimicrobial, anti-inflammatory and immunomodulatory properties.
15913029|NCT03550651|Other|Essential oil|Essential oils have a wide application in folk medicine, food flavoring and preservation as well as in fragrance industries. The antimicrobial properties of essential oils have been known for many centuries. In recent years, a large number of essential oils and their constituents have been investigated for their antimicrobial properties against some bacteria and fungi. Essential oils have the potential to be used as therapeutic agents for chronic gingivitis and periodontitis conditions that have both bacterial and inflammatory components.
15913030|NCT03550651|Other|Chlorhexidine Gluconate|Chlorhexidine is a symmetrical bisbiguanide synthetic antiseptic. It is available in three forms, digluconate, acetate and hydrochloride salts. Which have broad spectrum antimicrobial activity; it is effective against both Gram-positive and Gram-negative bacteria including aerobes and anaerobes, yeasts, fungi and lipid enveloped viruses. Chlorhexidine is considered to be the most effective plaque inhibitor against which other antiplaque agents are measured.
15913031|NCT03550651|Other|Distilled water|Distilled water is commonly placebo in various research projects and it is also useful in as placebo treatment.
15913032|NCT03550638|Device|Coil system(Ton-bridgeMT)|1. It consists of a push system with a development mark, and a Detachable platinum-tungsten alloy coil which is connected to the push system. It can be used for embolization of intracranial aneurysms, and other neurovascular abnormalities, such as arteriovenous malformation and arteriovenous fistula.
15913033|NCT03550638|Device|Axium Detachable Coil(Medtronic)|2. It is made up of a push system with a development mark, a platinum-tungsten alloy embolized coil connected to the push system and a manual release device for releasing the coil from the distal end of the push system. It is mainly used for embolization of intracranial aneurysms, and other neurovascular abnormalities, such as arteriovenous malformation and arteriovenous fistula.
15913034|NCT03550625|Diagnostic Test|Computer program|No study specific intervention. Still images of polyps are collected. Histopathological reports of the resected polyps will be evaluated in order to create a computer program.
15913035|NCT03550612|Diagnostic Test|magnetic resonant imaging,cranial ultrasound.|Magnetic resonant image performed at term gestation neonate suffer of hypoxic ischemic encephalopathy and its results will be analysed in details and classified according to global score of magnetic resonant image injury.Cranial ultrasound results will be analysed regards (periventricular - interventricular haemorrhage-Ventricular size-basal ganglia, thalamus and cerebellum affection) and Doppler (peak systolic flow velocity-end diastolic peak flow velocity-mean velocity and resistance index).Cerebral bleeding will be diagnosed be cranial ultrasound and confirmed be standard magnetic resonant image in term equivalent age.
15913036|NCT03550612|Diagnostic Test|Amplitude integrated electroencephalogram|"Amplitude integrated electroencephalogram before and during cooling will be assessed and classified according to Hellstrom Westas et al 2006 and it will be compared with the results of cranial ultrasound and magnetic resonant imaging.
~Neurodevelopment study at 12 and 14 month age using Bayley ɪɪɪ score will be compared with the results of cranial ultrasound,magnetic resonant imaging and Amplitude integrated electroencephalogram."
15913037|NCT03550599|Other|Patients accessing to Radiotherapy Unit|No intervention; information about patient and disease characteristics will be recorded as well as information about pain and analgesic treatment
15913038|NCT03550586|Other|Questionaires|Parturients will be assed for postpartum depression using the Edinburgh Postnatal Depression Scale (EPDS)translated into Hebrew . They will also be assed for PTSD using the validated PTSD questionnaire . Additionally in order to examine long term risk for chronic pain and backache parturients will be assed for persistent pain using the validated Brief Pain Inventory questionnaire ,and the validated Oswestry low back pain questionnaire .
15913039|NCT03550573|Device|CardioInsight™ Noninvasive 3D Mapping System|"The CardioInsight system uses a proprietary, single-use, disposable multi-electrode vest to capture electrical signals from the body surface. The CardioInsight software provides various cardiac signal analyses and displays interactive 3-D color maps including activation, voltage, composite and phase maps. The vest wearing is coupled with a CT scan.
~This exam will be performed only at baseline visit."
15913040|NCT03550560|Procedure|EUS-Guided drainage|Drainage of refractory malignant ascites by endoscopic ultrasound-guided (EUS-Guided) implantation of plastic prostheses.
15913041|NCT03550547|Other|Educational workshops|1 workshop : Knowledge of the pathology ; 2a workshop: Educational physical activity; 2b workshop : Educational physical activity; 4 workshop : Dietary; 5 workshop : Management of pain, fatigue and the medical treatments; 6 workshop : Articular hygiene and ergonomics; 7 workshop : Technical assistance, an adaptation of the living condition
15913042|NCT03550547|Other|Spa Therapy|Approved Spa therapy of knee osteoarthritis patients
15913043|NCT03550534|Drug|Calcium Carbonate|Calcium carbonate was obtained from Pharmacy Department, Faculty of Medicine, University of Indonesia. Subjects were randomized to receive calcium carbonate or placebo for 12 weeks.
15913044|NCT03550534|Drug|Placebo oral capsule|Placebo oral capsule was also obtained from Pharmacy Department, Faculty of Medicine, University of Indonesia. Subjects were randomized to receive calcium carbonate or placebo for 12 weeks.
15913045|NCT03550521|Behavioral|Mindfulness|Participants will be instructed to focus on the sensations of breathing. Subsequently, whenever their minds wander to distressing thoughts or emotions, they will be instructed to acknowledge those thoughts or emotions, and then bring their attention back to the sensations of breathing.
15913046|NCT03550508|Biological|Anti-RANKL Monoclonal Antibody|JMT103 is recombinant fully human anti-RANKL monoclonal antibody. JMT103 is provided as the injection,120 mg/vial. JMT103 was administered subcutaneously in the upper arm, upper thigh, or abdomen.
15913047|NCT03550495|Behavioral|psychiatry involvement|See arm description.
15913048|NCT03550482|Dietary Supplement|ONCOXIN®|Adjuvant chemotherapy regimen (XELOX or paclitaxel+carboplatin) + Oncoxin 25 ml twice daily for 20 days. In case of nausea/vomiting after ONCX use patients were advised to dilute it in water, juice or milk. Patients with BMI <20 and serum albumin levels <30 g/l received nutritional support.
15913049|NCT03550469|Device|Computer-assisted Oxygen Weaning|Oxygen therapy weaning will be guided by a model-based computer algorithm. The computer will detect patients' oxygen saturation and made recommendations for oxygen weaning. A clinical at the bedside will make the adjustments in oxygen therapy if appropriate.
15913050|NCT03550456|Other|ECC|Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber.
15913051|NCT03550456|Other|ECC with CLE|Continuous Laryngoscopy is endoscopy of the larynx used to obtain a view of laryngeal obstruction during exercise.
15913052|NCT03550456|Other|Speech therapy|Patients with diagnosis of EILO will be sent to a speech therapist for at least 6 training sessions.
15913053|NCT03550443|Drug|Bardoxolone methyl|Bardoxolone methyl 5 mg capsules
15913054|NCT03550443|Drug|Placebo|Capsules containing an inert placebo
15913055|NCT03550430|Behavioral|alpha/delta neurofeedback|neurofeedback training protocol seeking to decrease the alpha/delta ratio, by simultaneous rewarding alpha and inhibiting delta activity.
15913056|NCT03550430|Behavioral|beta/theta neurofeedback|neurofeedback training protocol seeking to decrease the beta/theta ratio, by simultaneous rewarding beta and inhibiting theta activity.
15913057|NCT03550430|Other|Diary completion|completion of diary relating to participants' experience of tinnitus intensity, interference, coping, harm and disability. Rated three times daily on numerical scale (0 - 10) for two weeks.
15913058|NCT03550404|Behavioral|Seasons of Care App|A web-based mobile application (app) called the Seasons of Care Elder Navigation Guide will assist elders, their families/caregivers, healthcare providers, outreach workers, and other community members in navigating healthcare and insurance systems. The app has the added advantage of being easy to update to respond to future changes in health care and insurance, and sustainable because it is not dependent on intensive training, developing, and retaining of individuals in professional navigation positions.
15913059|NCT03550391|Drug|Memantine|20 mg (10 mg divided twice daily). Dose will be escalated by 5 mg per week. Memantine should start at 5 mg, and then increased in 5 mg increments at the following schedule, depending on the patient's response and tolerance:
15913060|NCT03550391|Radiation|Hippocampal-avoidant (HA-WBRT) Radiotherapy|30Gy in 10 fractions
15913061|NCT03550391|Procedure|Stereotactic Radiosurgery (SRS)|18-20 or 22 Gy in single fraction
15913062|NCT03550378|Drug|MEDI0382|Participants will receive subcutaneous MEDI0382 titrated from 50 μg upto 300 μg (50 μg once daily for 4 days, followed by 100 μg daily for 7 days, 200 μg daily for 7 days, and 300 μg daily for 14 days) for 32 days.
15913063|NCT03550378|Drug|Placebo|Participants will receive SC placebo matched to MEDI0382 once daily for 32 days.
15913064|NCT03550365|Other|Rye bran bread intervention|4 week dietary intervention rich in rye bran bread
15913065|NCT03550365|Other|Rye bread intervention|4 week dietary intervention rich in rye bread
15913066|NCT03550365|Other|Wheat bread diet|4 week dietary intervention rich in wheat bread as an active comparator for previous two interventions
15913067|NCT03550352|Drug|TN-TC11M2 oral capsules (THC 2.5 mg/CBD 2.5 mg)|Participants will start by taking 1 capsule twice daily for 1 week (5 mg THC/5 mg CBD) and increase the number of capsules as tolerated to a maximum of 6 capsules taken throughout the day by weeks 5-12 (15 mg THC/15 mg CBD total per day).
15913068|NCT03550352|Drug|TN-C200M2 oral capsules (CBD 200 mg)|Participants will start by taking 1 capsule once daily for 1 week (200 mg CBD) and increase the number of capsules as tolerated to a maximum of 4 capsules taken throughout the day by weeks 5-12 (800 mg CBD total).
15913069|NCT03550339|Procedure|SURG|bariatric surgery according to Finnish Current Care Guidelines for Obesity in adults
15913070|NCT03550339|Behavioral|DIET|dietary weight loss program according to Finnish Current Care Guidelines for Obesity in adults
15913071|NCT03550339|Behavioral|HAES|treatment is based on the previously published procedure (e.g. Bacon et al. 2002) and Health At Every Size trademark, consisting of body acceptance, eating behaviour, physical activity, nutrition, and social support
15913072|NCT03550326|Procedure|airway management|patients will be intubated or will be placed an airway device
15913073|NCT03550313|Biological|Multivalent|Pneumococcal conjugate vaccine
15913074|NCT03550313|Biological|Prevnar 13|Pneumococcal conjugate vaccine
15913075|NCT03550287|Dietary Supplement|Experimental product|10 g/day
15913076|NCT03550287|Dietary Supplement|Placebo product|10 g/day
15944100|NCT03310021|Drug|Rivaroxaban|factor Xa inhibitor
15913077|NCT03550274|Device|App-based exercise rehabilitation|"App-based exercise rehabilitation available on any mobile device and/or tablet using Android or iOS operating systems. The app Injurymap© is hosting the exercise program. The app requires user-registrations and a monthly paid subscription fee to access the exercise program. The participants in this study will not be charged for using the app.
~The exercise program consists of three phases with increasing difficulty. Each phase consists of several categories of exercise types. The categories are 1) mobility, 2) stability/balance, 3) strength and 4) stretching. Within each phase, there can be more than one exercise for each category. This makes it possible to adjust the difficulty of the exercises depending on user-feedback."
15913078|NCT03550248|Behavioral|Healthy Together|The Healthy Together (HT) program is designed to reduce overweight and obesity among children and youth in priority populations such as Indigenous, immigrant and refugee, and low income families.The HT program consists of 30 sessions, each of which includes cooking and eating together, physical activity and a learning activity covering topics that promote healthy weights. The HT program is delivered by trained facilitators who are provided with a program manual and resources. Trained facilitators in participating community organizations offer the HT program by integrating it within core programming.
15913079|NCT03550209|Drug|LCPUFA Oil Supplement|25 mg/kg, 50 mg/kg, or 75 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days
15913080|NCT03550209|Dietary Supplement|Canola Oil Placebo|Equal volume (25 mg/kg, 50 mg/kg, or 75 mg/kg) of placebo (canola) oil to be administered twice per day by mouth for 90 days
15913081|NCT03550196|Other|Provisional stenting with rePOT technique|"All revascularizations have to be performed with complete rePOT technique: initial POT + side branch inflation + final POT. Compliant or semi compliant balloon have to be preferred to inflations. The POT balloon positioning have to be precise as obtain the loose of the parallelism just at the carina cut plan. The rest of the medication or procedure characteristics stay at the discretion of the operator.
~The follow-up will be clinic every years."
15913082|NCT03550183|Biological|mesenchymal stem cells|Patients with PD in the therapy group were given UC-MSCs by intravenous infusion and conventional therapy. There was only conventional treatment in the control group. All patients after treatment for 1 month, 3 months, 6 months and 12 months were evaluated respectively the curative effect.
15913083|NCT03550170|Behavioral|Teleconference|This intervention arm will be a 6-week, group-based course involving weekly 80-min teleconference sessions. It will be delivered in small groups (6-12 participants) to maximize participants' opportunities for interaction. A program manual divided into 6 sections, 1 for each week that includes worksheets and homework activities will be given to the participants. Occupational therapists will facilitate the sessions. Participants and the OT will dial into 1-800 conference call line on the designated date and time.
15913084|NCT03550170|Behavioral|Internet|The internet course is similar to the teleconference format. It will occur in a 6-week period and be group based; i.e., 8-12 participants will begin the intervention at the same time and interact with each other during the 6-week period. Participants will be given a username and a password to view a different session each week at a time convenient for them. Each session will include completing practice activities and sharing information (e.g., offering advice and support to one another through the discussion forum). OTs will facilitate the discussions by responding to entries, asking questions, and providing encouragement to complete sessions.
15913085|NCT03550170|Behavioral|1-to-1, in-person|Unlike the teleconference and internet courses, the number and length of sessions for the 1-to-1, in-person course will vary over the 6-week period. The OT will cover all 6 topics, but the pace will be tailored to the participants' needs and preferences. Thus, although the topics are consistent, OTs are able to spend more time on topics that participants find pertinent to their situations. The participant and OT will be instructed to meet at least 3 times with at least 7 days between each session.
15913086|NCT03550144|Behavioral|Awe Walk|To examine the effect of weekly awe walks in cognitively healthy older adults.
15913087|NCT03550144|Behavioral|Control Walk|To examine the effect of weekly walks in cognitively healthy older adults.
15913088|NCT03550131|Behavioral|Innovations in Dementia Empowerment and Action (IDEA)|The IDEA intervention has the same exposure to treatment as the RDAD intervention. The behavioral component of the treatment manual is adapted to incorporate 3 risk factors that are empirically known to affect midlife and older LGBT populations.These include: 1) identity management; 2) stigma-related adverse/traumatic life events; and 3) lack of social support. All other aspects of the treatment are preserved.
15913089|NCT03550131|Behavioral|Reducing Disabilities in Alzheimer's Disease (RDAD)|The RDAD intervention includes behavioral management training for caregiver and activities and exercise training for caregiver and care receiver.
15913090|NCT03550118|Device|Adjustable socket|The adjustable prosthetic socket will be used to test the influence of socket size adjustments during sitting, standing, and walking activities to determine if these strategies can be used to improve socket fit and reduce fluctuations in limb volume.
15913091|NCT03550105|Device|Gentle Jogger|Gentle Jogger is a passive simulated jogging device to be used 3 times per day for at least 30 mins for 7 days in this study
15913092|NCT03550092|Behavioral|Abstract Semantic Association Network Training (AbSANT)|In each session, the participant will be asked to categorize words, choose/discuss semantic features for each word that accurately describe the word, and generate as many words as possible within a category.
15913093|NCT03550079|Procedure|fixation|treated with different fixation method
15913094|NCT03550066|Behavioral|Values affirmation|A health message with a prompt asking participants to reflect on important personal values
15913095|NCT03550066|Behavioral|No affirmation|A health message alone
15913096|NCT03550053|Device|3D mandibular plate|Patients will be randomly assigned to either have the mandibular plate bent before their surgery, using a 3D model of their mandible or have the mandibular plate bent during their surgery, which is standard of care.
15913097|NCT03550040|Procedure|Radical prostatectomy|Surgical removal of the prostate
15913098|NCT03550027|Device|PleurX|Positioning of drainage PleurX
15913099|NCT03550027|Device|Pleurocath|Positioning of drainage Pleurocath
15913100|NCT03550014|Procedure|Low Back Only|The physical therapy interventions are commonly performed in and may include stretching, strengthening, hands-on techniques, etc. The interventions will only be directed at the lower back. Standard plan of care delivered to participants with low back pain and concurrent hip impairments within scope of licensure.
15944101|NCT03310021|Drug|Edoxaban|factor Xa inhibitor
15913101|NCT03550014|Procedure|Low Back+Hip|The physical therapy interventions are commonly performed in and may include stretching, strengthening, hands-on techniques, etc. The interventions will be directed at the lower back and the hips. Standard plan of care delivered to participants with low back pain and concurrent hip impairments within scope of licensure.
15913102|NCT03550001|Procedure|Injection CNP before NAT|Injection carbon nanoparticle via rectal mucosa before neoadjuvant therapy
15913103|NCT03549988|Other|Fecal Calprotectin (FC) measurements with IBDocTM|"Each IBDocTM kit measure one fecal calprotectin value. The IBDoc® is an in-vitro diagnostic immunoassay analyzed by a downloadable smartphone application (CalApp®). A patient is able to process their stool at home using a test cassette.
~The IBDocTM test results are displayed in a light signal system as three titre categories; normal <100 µg/g (green), 100-300 µg/g (yellow), >300 µg/g (high). Patients' results will be sent directly to the central research coordinator through the IBDoc® Web Portal. If the FC is >250 µg/g a second FC will be performed within 2 weeks. If this result is <250 µg/g patients will continue to monitor their FC every 2 months. If the second result is >250 µg/g, the attending physician will review the patient either by telephone or in the office within 7 days."
15913104|NCT03549975|Drug|Botulinum Toxin Type A 100 unit/Vial (Product)|Botulinum toxin type A injection followed by functional electrical stimulation
15913105|NCT03549962|Procedure|TKA|Total Knee Arthroplasty
15913106|NCT03549936|Other|Low lactose or regular formula|"If infant is not breast feeding and parents plan to formula feed, following written informed consent, infant is randomized to receive low lactose formula or regular formula which arrives from milk lab blinded and labeled as formula A or formula B."
15913107|NCT03549923|Device|Simultaneous CRRT|The patients in the simultaneous CRRT group will receive CRRT within 24 hours after the initiation of ECMO support.
15913108|NCT03549923|Device|Conventional-indication CRRT|The patients in the conventional-indication group will not receive CRRT until the patient demonstrates AKI and fulfills any one of the criteria of the conventional CRRT indication.
15913109|NCT03549923|Drug|Esmolol|The patients in esmolol group will receive a continuous esmolol infusion in addition to the standard care.
15913110|NCT03549923|Drug|Standard care|The patients in control group will not receive any beta-blockers, including esmolol, unless the doctor thinks there's a strong indication.
15913111|NCT03549910|Procedure|APRVplus protocol|Physiology-driven APRVplus protocol
15913112|NCT03549910|Procedure|Low tidal volume ventilation|Low tidal volume lung protective ventilation
15913113|NCT03549897|Drug|Placebo|Placebo Product
15913114|NCT03549897|Drug|90 mcg Reference Product|90 mcg Reference Product - PROAIR HFA ALBUTEROL SULFATE [TEVA RESPIRATORY, LLC]
15913115|NCT03549897|Drug|180 mcg Reference Product|180 mcg Reference Product- PROAIR HFA ALBUTEROL SULFATE [TEVA RESPIRATORY, LLC]
15913116|NCT03549897|Drug|90 mcg Test Product|90 mcg Test Product - ALBUTEROL SULFATE HFA [AMNEAL IRELAND LIMITED]
15913117|NCT03549884|Procedure|Delayed cord clamping|Cord clamping will be performed after 60 seconds of life in infants delivered by cesarean section
15913118|NCT03549884|Procedure|Early cord clamping|Cord clamping will be performed within 10 seconds of life in infants delivered by cesarean section
15913119|NCT03549871|Drug|Fitusiran|Pharmaceutical form: solution for injection Route of administration: subcutaneous
15913120|NCT03549858|Other|Quality of life measure (survey)|The QoL tool is a questionnaire
15913121|NCT03549845|Behavioral|Cardiovascular Health Awareness Program|Cardiovascular disease prevention and health promotion
15913122|NCT03549832|Drug|Sofosbuvir|Sofosbuvir 400 mg oral pills
15913123|NCT03549832|Drug|Simeprevir|Simeprevir 150 mg oral pills
15913124|NCT03549832|Drug|Daclatasvir|Daclatasvir 60 mg oral pills
15913125|NCT03549832|Drug|Ribavirin|Ribavirin 200 mg oral pills
15913126|NCT03549832|Drug|Ombitasvir/paritaprevir/ritonavir|Ombitasvir/paritaprevir/ritonavir oral pills
15913127|NCT03549819|Drug|Cannabidiol (CBD) Oil Capsules|"200 mg CBD- titrated as tolerated up to a maximum 2 capsules twice daily (200 mg- 800 mg total dose)
~Start at 1 capsule/day (at bedtime) for one week and be titrated to 1 capsule twice/daily for one week. At the end of Week 2, dose may be titrated to 1 capsule in the morning and 2 capsules at bedtime; then at the end of Week 4, dose may be titrated to 2 capsules twice daily (the maximum of 800 mg/day total dose)"
15913128|NCT03549819|Drug|Sunflower Lecithin Oil in Capsule|Start at 1 capsule/day (at bedtime) for one week and be titrated to 1 capsule twice/daily for one week. At the end of Week 2, dose may be titrated to 1 capsule in the morning and 2 capsules at bedtime; then at the end of Week 4, dose may be titrated to 2 capsules twice daily (the maximum of 800 mg/day total dose)
15913129|NCT03549806|Diagnostic Test|No Intervention. Test is computer algorithm.|Diagnostic algorithms (test) will be run on already acquired clinical data. No study intervention in operator-prescribed clinical ablation. Predictive accuracy of test for study outcome will then be determined in follow-up
15913130|NCT03549793|Behavioral|Dance Therapy|the intervention is aimed to ameliorate, through dancing, crucial motor symptoms in PD patients, as walking, balance, postural changes and arm swing
15913131|NCT03549793|Behavioral|exercises without dance|the intervention consists of exercises aimed at training the walking, the balance, the postural changes and the arm swing
15913132|NCT03549780|Device|Stomal Occlusion Device|Insertion of a novel stomal occlusion device into patients with Brooke Ileostomy and assess feasibility and patient satisfaction
15913133|NCT03549767|Device|Springfusor|Springfusor for administration of magnesium sulphate
15913134|NCT03549767|Procedure|Standard of care|Pritchard regimen. Magnesium sulphate is administered using hospital practice
15913135|NCT03549741|Drug|Clomiphene Citrate 50mg|oral tablets
15913136|NCT03549741|Drug|Cabergoline Oral Tablet|oral tablets
15913137|NCT03549741|Drug|Placebo Oral Tablet|oral tablets
15913138|NCT03549728|Drug|Granulocyte Colony-Stimulating Factor|In group A, at the day of oocyte retrieval, after oocytes collection, 30 mU (300 mcg/0.5 ml) of G-CSF (NeupogenTM, Filgastrim, Amgen Inc., Thousand Oaks, CA, USA) was administered by slow transcervical intrauterine infusion with IUI catheter (AINSEGREY, RIMOS, Italy). In controls, normal saline was used for intrauterine infusion instead of G-CSF.
15913139|NCT03549728|Procedure|Intrauterine infusion of normal saline|In group B (controls), normal saline will be used for intrauterine infusion instead of granulocyte colony-stimulating factor on the day of oocyte retrieval.
15944102|NCT03310021|Drug|Placebo|Placebo
15913143|NCT03549702|Drug|Povidone iodine 1% solution|irrigation of subcutaneous tissue with Povidone-Iodine prior to skin closure
15913144|NCT03549689|Drug|Dolutegravir (DTG) 50MG/lamivudine (3TC) 300MG FIXED DOSE COMBINATION (FDC)|Participants randomized to the Switch Arm will take DTG 50mg/3TC 300mg FDC once daily with or without food at approximately the same time each day.
15913145|NCT03549689|Drug|Current tenofovir alafenamide (TAF)-containing ART regimen|Continuation of current TAF-containing ART for 96 weeks.
15913146|NCT03549676|Biological|Fecal Microbiota Transplantation|For patients who do not respond or partial respond for first time FMT treatment, a second time FMT treatment using different donor should be considered.
15913147|NCT03549663|Drug|Tacrolimus|Tacrolimus capsules: 0.5mg/pill, 50 pills/box, AstellasPharma (China) Co., Ltd.; Tacrolimus capsules: 1mg/pill, 50 pills/box, Hangzhou ZhongmeiHuadong Pharmacy Co., Ltd. Start to administer on the randomized grouping day (D0) with an initial dose by weight: initial dose of 0.05-0.075mg/kg/d (bid) following a strict administration interval of 12 hours or fasting or 2 hours after meal. Adjust TAC dose according to 24-hour urine protein, plasma concentration and eGFR changes. It is recommended that plasma trough concentration should be remained at 5-8ng/ml and TAC dose during the whole therapy stage should not be lower than 0.5mg/d. Drugs should be stopped if the 6-month therapy is ineffective. After 6-month therapy, for those whose urine protein achieved complete remission (CR) or partial remission (PR), TAC dose should be reduced gradually with a total therapy duration of 48 weeks.
15913148|NCT03549663|Drug|Prednisone|Glucocorticoid (prednisone): 5mg/pill, 100 pills/bottle: Shanghai Sine Pharmaceutical Factory Co., Ltd. The initial dose of prednisone should be 0.5mg/kg/d orally (maximum dose of 40mg/d) and administration should be continued for 8-12 weeks; then reduced by the monthly decreased amount of 0.1mg/kg/d till to 0.2mg/kg/d (5-10mg) to maintain. Prednisone should be stopped after administration for the entire 48 weeks.
15913149|NCT03549650|Drug|Pentosan Polysulfate Na 100Mg Cap|"Participants will be randomly assigned to receive Pentosan Polysulfate Na 100Mg Cap TID for 6 weeks.
~For blinded distribution, each bottle of medications will be labeled with a random number for identification.
~The study participants will be monitored every 2 weeks with phone calls from the study team to evaluate their condition and decide if the medication is tolerated and whether it should be continued or stopped."
15913150|NCT03549650|Drug|Placebo oral capsule|"Participants will be randomly assigned to receive Placebo oral capsule TID for 6 weeks.
~For blinded distribution, each bottle of medications will be labeled with a random number for identification.
~The study participants will be monitored every 2 weeks with phone calls from the study team to evaluate their condition and decide if the medication is tolerated and whether it should be continued or stopped."
15913151|NCT03549637|Diagnostic Test|Psychiatric population|Genetic and biological analysis of patients
15913152|NCT03549624|Other|Standardised protocol for the perioperative management in patients in need of an acute laparotomy|A standardised protocol for the perioperative management of patients including early start of antibiotics and swift surgical intervention as well as an emphasis on repeated monitoring of physiological parameters pre- and post-operatively.
15913153|NCT03549611|Drug|Multimodal Oral Drug Regimen|Regimen of 4 pharmacologic agents that provides analgesia by acting on 4 different physiologic pain pathways
15913154|NCT03549611|Drug|Acetaminophen|Acetaminophen 975mg
15913155|NCT03549598|Drug|68Ga-DOTATATE PET/CT|5.4 mCi of 68Ga-DOTATATE will be administered by intravenous route.
15913156|NCT03549598|Drug|18FDG PET/CT scan|This scan will be performed as part of the planned clinical care for the patient. Dose of 18FDG will be administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan will also be performed as part of this examination per institutional protocol.
15913157|NCT03549598|Drug|13NH3 PET/CT scan|This scan will be performed as part of the planned clinical care for the patient. Dose of 13NH3 will be administered intravenously in accordance with the institutional policy and accepted norms. CT attenuation scan will also be performed as part of this examination per institutional protocol.
15913158|NCT03549585|Other|Criteria for Screening and Triaging to Appropriate aLternative care|CriSTAL Tool (Criteria for Screening and Treatment of Appropriate Long-Term Care) is a multidimensional geriatric tool that lists 18 elements of the literature, under construction and validation by an Australian retrospective study. This tool is a practical questionnaire and easy to use in current care, with items adapted to the geriatric dimension. The investigators chose to target hospitalized geriatric patients through emergencies.
15913159|NCT03549572|Behavioral|Coma Recovery Scale-Revised|Patients will be assessed using the CRS-R and the CRSR-FAST. The CRS-R is a standardized neurobehavioral rating scale that consists of 23 items organized into six subscales that address arousal, auditory, visual, motor, oromotor/verbal, and communication systems. Each subscale is organized hierarchically, with lower items representing reflexive behaviors and higher items indicative of cognitively-mediated behaviors. Reliability and validity have been demonstrated in multiple studies. The CRSR-FAST consists of 10 items organized into 4 subscales that address arousal, visual, motor and verbal/oromotor systems. Each subscale is organized hierarchically, with lower items representing reflexive behaviors and higher items indicative of cognitively-mediated behaviors.
15913160|NCT03549559|Drug|11C-Martinostat|Imaging probe for evaluating the activity of histone deacetylase in the heart
15913161|NCT03549559|Device|PET-MRI|Siemens PET-MR Scanner (Biograph MMR)
15913162|NCT03549546|Biological|Blood samples|"Blood samples will be collected in patients undergoing lung cancer surgery:
~before lung cancer surgery,
~the next day lung cancer surgery,
~3 days after lung cancer surgery. They will be treated in flow cytometry."
15913163|NCT03549533|Other|samples of sperm|As in the usual practice during artificial insemination a samples of sperm will be collected and analyzed.
15913164|NCT03549520|Drug|Sulfur hexafluoride lipid-type A microspheres|Injection of Sulfur hexafluoride lipid-type A microspheres (Lumason) contrast agent will be performed via the existing peripheral intravenous line using the FDA-recommended dose of 0.03 mg/kg.
15913167|NCT03549468|Device|Low level tragus stimulation|All patients will undergo sequentially: sham stimulation; LLTS (5Hz), LLTS (20Hz). The sequence will be repeated during atrial pacing at 100bpm
15913168|NCT03549455|Behavioral|Exposure Therapy and Self Distancing|Weeks 1 and 2 will be introductory sessions (background, rationale, motivational enhancement); Weeks 3 & 4 will have Exposure therapy with Self-Distancing; Weeks 5 & 6 will have Exposure therapy only; Weeks 7 & 8 will have Exposure therapy with Self-Distancing;
15913169|NCT03549442|Combination Product|BCMA CART + huCART19|The target dose for CART-BCMA and huCART19 will be 5x108 CAR-expressing cell for each product. Split dose infusions will consist of a 10% dose (of one or both products) on the first infusion day, 30% dose (of one or both products) on the second infusion day, or 60% dose (of one or both products) on the third infusion day. Infusion days may be spread over 7 calendar days due to scheduling constraints or to allow observation of suspected early cytokine release syndrome or other toxicity. Infusions will begin 3 days (+/- 1 day) after completion of lymphodepleting chemotherapy with cyclophosphamide + fludarabine.
15913170|NCT03549442|Combination Product|CART BCMA or CART BCMA + huCART19|The target dose for CART-BCMA and huCART19 will be 5x108 CAR-expressing cell for each product. Cohort 1 refers to the group of subjects assigned to receive CART-BCMA alone; Cohort 2 refers to the group of subjects assigned to receive CART-BCMA + huCART19. Split dose infusions will consist of a 10% dose (of one or both products) on the first infusion day, 30% dose (of one or both products) on the second infusion day, or 60% dose (of one or both products) on the third infusion day. Infusion days may be spread over 7 calendar days due to scheduling constraints or to allow observation of suspected early cytokine release syndrome or other toxicity. Infusions will begin 3 days (+/- 1 day) after completion of lymphodepleting chemotherapy with cyclophosphamide + fludarabine.
15913171|NCT03549442|Combination Product|Single-dose infusion of CART BCMA or CART BCMA + huCART19|The target dose for CART-BCMA and huCART19 will be 5x108 CAR-expressing cell for each product. Cohort 1 refers to the group of subjects assigned to receive single dose infusions of CART-BCMA alone; Cohort 2 refers to the group of subjects assigned to receive single dose infusions of CART-BCMA + huCART19. Infusions will begin 3 days (+/- 1 day) after completion of lymphodepleting chemotherapy with cyclophosphamide + fludarabine.
15913172|NCT03549442|Combination Product|BCMA CART + huCART19|The target dose for CART-BCMA and huCART19 will be 5x108 CAR-expressing cell for each product. Split dose infusions will consist of a 10% dose (of one or both products) on the first infusion day, 30% dose (of one or both products) on the second infusion day, or 60% dose (of one or both products) on the third infusion day. Infusion days may be spread over 7 calendar days due to scheduling constraints or to allow observation of suspected early cytokine release syndrome or other toxicity. Infusions will begin 3 days (+/- 1 day) after completion of lymphodepleting chemotherapy with cyclophosphamide + fludarabine.
15913173|NCT03549429|Device|Medical tapes: TegadermTM and EyeGard®|TegadermTM and EyeGard® will be placed over patients' eyes during surgery with general anesthesia.
15913174|NCT03549403|Behavioral|Patient-centered telephone education|The intervention will be carried out in accordance with the guidelines and the contents of the patient-centered telephone education intervention in the same way with every patient. The education call duration is approximately 15 to 30 minutes.
15913175|NCT03549390|Behavioral|Physical activity|Light-moderate intensity physical activities
15913176|NCT03549377|Behavioral|Deception|Participants will be deceived during delayed gratification task.
15913177|NCT03549364|Behavioral|Endurance Race|1 CT and lab tests, 2 CT and lab tests within 24h of a race, 3 follow up investigations 1-2 weeks after the race with CT and lab tests
15913178|NCT03549351|Other|Measurable residual disease measured by flow cytometry|Measurable residual disease measured by flow cytometry
15913179|NCT03549338|Drug|Sym004|Sym004 is a 1:1 mixture of two recombinant mAbs (futuximab and modotuximab) which bind specifically to non-overlapping epitopes located in the extracellular domain (ECD) of the EGFR.
15913180|NCT03549338|Drug|Futuximab|Futuximab is one of two mAb components that constitute Sym004.
15913181|NCT03549338|Drug|Modotuximab|Modotuximab is one of two mAb components that constitute Sym004.
15913182|NCT03549325|Biological|Neisseria lactamica|Colonisation by bacteria is an immunising event; we proved this in humans by inoculating university students intranasally with the harmless commensal N. lactamica and we observed both specific systemic and mucosal antibody responses by 4 weeks. Experimental challenge with defined bacteria could tease out the Th17-mediated response mechanisms, which include waning of immunity over time, the induction of an incorrectly polarised T cell response, lack of cross-reactivity between strains or active immune evasion mechanisms employed by bacteria to subvert host immune effector mechanisms.
15913183|NCT03549312|Drug|Genvoya|"Switching to Genvoya for 48 weeks in patients with HIV/HCV co-infection and stably suppressed HIV RNA, prior to starting HCV treatment, while receiving methadone or buprenorphine/naloxone as opioid substitution therapy.
~Plasma HIV-1 RNA < 50 copies/mL at weeks 4, 12, 24, 36 and 48."
15913184|NCT03549312|Drug|Epclusa|"HCV therapy with direct-acting-antiviral therapy with Epclusa in HIV-HCV co-infected patients with suppressed HIV RNA, receiving methadone as opioid substitution therapy.
~Plasma HCV RNA viral load at weeks 12, 24, 36, 48, 72 and 96."
15913185|NCT03549312|Drug|Biktarvy|"Switching to Biktarvy for 48 weeks in patients with HIV previously treated with Genvoya, stably supressed HIV RNA, while receiving methadone or buprenorphine/naloxone as opioid substitution therapy.
~Plasma HIV-1 RNA < 50 copies/mL at weeks 52, 60, 72, 84 and 96."
15913186|NCT03549299|Biological|LSC2|Topical application of IMP on target eye
15913187|NCT03549286|Other|Questionnaire passation|Questionnaires assessing general knowledge about Down's syndrome screening, specific knowledge of NIPT for Down's syndrome and patient's satisfaction about provided information.
15913277|NCT03548506|Device|Directional Deep Brain Stimulation of STN|Deep Brain Stimulation
15944744|NCT03305003|Other|Mobile application|
15913189|NCT03549260|Biological|LIB003|LIB003 or placebo
15913190|NCT03549247|Behavioral|quality of life in healthy,gingivitis,periodontitis groups|a questionnaire form evaluating oral hygiene habits and oral hygiene consciousness levels, OHIP-14 scale was applied
15913191|NCT03549234|Drug|Erector Spinae (single injection)|Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.
15913192|NCT03549234|Drug|Paravertebral (single injection)|Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.
15913193|NCT03549221|Drug|0.6 mg 1:1000 epinephrine (0.6 ml)|In group 1, the multimodal anesthetic cocktail consisted of 100 mg Levobupivacaine (0.5%, 20 mL) 30 mg ketorolac (1 ml) and 0.6 mg 1:1000 epinephrine (0.6 ml). In group 2, the multimodal anesthetic cocktail consisted of 100 mg Levobupivacaine (0.5%, 20 mL) and 30 mg ketorolac (1 ml). Both groups were mixed with a 0.9% normal saline solution to a total volume of 100 ml.
15913194|NCT03549208|Biological|LBVE01|Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
15913195|NCT03549208|Biological|LBVE02|Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
15913196|NCT03549208|Biological|Prevnar13|13-valent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
15913197|NCT03549195|Procedure|ICG|The ICG powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.
15913198|NCT03549195|Procedure|ICG-CP|The ICG-CP powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.
15913199|NCT03549195|Procedure|ICG-TMTP1|The ICG-TMTP1 powder was diluted and injected into the cervix, divided into 3 and 9 o'clock position, 4 hours before surgery.
15913200|NCT03549182|Drug|ATD treatment|oral administration of ATD (100g)(Acute Tryptophan Depletion)
15913201|NCT03549182|Drug|placebo treatment|oral administration of placebo (102.3g)
15913202|NCT03549169|Behavioral|TOMAS|Intervention focused on decision making for the management of symptoms aimed at adults with heart failure.
15913203|NCT03549169|Behavioral|Regular attention|Regular attention focused on education for therapeutic adherence
15913204|NCT03549156|Dietary Supplement|C-RUSF|-RUSF contains whey permeate, WPC 80, peanut paste, sugar, soy oil, canola oil, a customized micronutrient premix to account for the minerals in whey permeate, and an emulsifier
15913205|NCT03549156|Dietary Supplement|HIPRO RUSF|HIPRO RUSF contains extruded soy flour, skimmed milk, peanut paste, sugar, soy oil, palm oil, a premix containing concentrated minerals and vitamins, an emulsifier and dicalcium phosphate or calcium carbonate
15913206|NCT03549143|Other|IBS|No intervention, description of routine practice only
15913207|NCT03549130|Device|Breathe Right Tan (small/medium) nasal strips|Participants of this treatment arm applied sufficient quantity of commercially available nasal strips (Breathe Right Tan), small/medium sized outside of the nose, from alar crease to alar crease, as per dispensing instructions, prior to sleeping. Participants used their assigned strip every night, for approximately 8 hours, but no more than 12 hours per night, for two weeks
15913208|NCT03549130|Other|Placebo nasal strip|Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH Nasal Strips, small/medium sized outside of the nose, from alar crease to alar crease, as per dispensing instructions, prior to sleeping. Participants used their assigned strip every night, for approximately 8 hours, but no more than 12 hours per night, for two weeks
15913209|NCT03549117|Device|Breathe Right Tan (small/medium) nasal strips|Participants of this treatment arm applied sufficient quantity of commercially available nasal strips (Breathe Right Tan), small/medium sized outside of the nose, from alar crease to alar crease, as per dispensing instructions, prior to sleeping. Participants used their assigned strip every night, for approximately 8 hours, but no more than 12 hours per night, for two weeks
15913210|NCT03549117|Other|Placebo nasal strip|Participants of this treatment arm applied sufficient quantity of Asymmetric Butterfly Placebo ABP-NH Nasal Strips, small/medium sized outside of the nose, from alar crease to alar crease, as per dispensing instructions, prior to sleeping. Participants used their assigned strip every night, for approximately 8 hours, but no more than 12 hours per night, for two weeks
15913211|NCT03549104|Behavioral|Fear Reduction Intervention|FREE
15913212|NCT03549104|Behavioral|Attention Control|DSMES
15913213|NCT03549091|Diagnostic Test|transthoracic echocardiography|This involves the acquisition of 1 additional sequence: a 10-minute sequence for transthoracic echocardiography.
15913214|NCT03549091|Diagnostic Test|Cardiovascular Magnetic Resonance Imaging|This involves the acquisition of 1 additional sequence: a 10-minute sequence for Cardiovascular Magnetic Resonance Imaging 4D Flow.
15913215|NCT03549078|Behavioral|Intervention|"Subjects will attend a series of 2 hour classes, once a week for 10 weeks. Topics discussed in group sessions will cover compensation strategies (e.g., calendar, goal setting and task lists, functional zones) and brain health behaviors (e.g., exercise, cognitive activity, stress reduction and mindfulness).
~Subjects may be asked to wear an actigraphy monitor (that looks like a wrist watch) and/or heart rate sensor that is designed to collect information regarding physical activity."
15913216|NCT03549065|Device|Brain Stimulation|"Transcranial magnetic stimulation (TMS) is a minimally invasive brain stimulation method that stimulates the brain of an individual focally(George & Belmaker, 2007). TMS pulses that are delivered repetitively and rhythmically are referred to as repetitive TMS (rTMS).
~Transcranial direct current stimulation (tDCS) is another form of non-invasive brain stimulation that is being investigated as an intervention for neurological and psychiatric disorders. A weak direct electrical current (0-2 mA) flows between two small electrodes via saline soaked sponges placed on the scalp (Nitsche MA et al, 2008)."
15913217|NCT03549026|Drug|Duloxetine|The investigator will give the patients duloxetine capsule 60 mg orally before operation (skin incision) and anesthetize them with general anesthesia, then the investigator will test the postoperative analgesic efficacy in the form of 24 h analgesic consumption
15913278|NCT03548493|Drug|Magnesium sulphate|Magnesium sulphate will be given to the experimental group in a dose of 50mg/kg IV over 15 minutes followed by continuous infusion at 15 mg/kg/h
15913218|NCT03549026|Drug|placebo|Patients will receive single oral dose of placebo capsule, 2 hours before operation and will be anesthetized with general anesthesia that includes, Induction of anesthesia will be done by intravenous fentanyl, 2 µg / kg and propofol 1 - 2 mg / kg. Endotracheal intubation will be achieved by cis-atracurium, 0.15 mg / kg. Maintenance of anesthesia will be done by isoflurane and cis-atracurium, 0.03 mg / kg on demand. Additional intraoperative analgesia will be consisted of administration of intravenous boluses of fentanyl, 50 µg according to the attending anesthesiologist's decision. At the end of surgery, muscle relaxation was reversed using neostigmine 0.05 mg / kg and atropine 0.01 mg / kg
15913219|NCT03549000|Other|NZV930|NZV930, Specified dose on specified days, intravenous (IV)
15913220|NCT03549000|Other|PDR001|PDR001, Specified dose on specified days, intravenous (IV)
15913221|NCT03549000|Drug|NIR178|NIR178 Specified dose on specified days, Orally
15913222|NCT03548987|Drug|Semaglutide|Subcutaneous (under the skin) injection of semaglutide once-weekly.
15913223|NCT03548987|Drug|Placebo|Subcutaneous (under the skin) injection of semaglutide placebo once-weekly.
15913224|NCT03548974|Behavioral|Treatment group 1|The ms-intakt/MOTOmed-intervention is a home-based program using the MOTOmed movement trainer: 12 week passive, motor-driven movement therapy followed by 12 weeks of intermittent active and passive training after the 3month assessment. Training intensity was regulated by the participant's subjective, perceived exertion, which was rated between 6 and 20 on the BORG Scale. Therapists aimed at eliciting a BORG Feedback of between 10 (fairly light) and 15 (hard). The exercise training was home-based and supervised via the internet.
15913225|NCT03548974|Behavioral|Treatment group 2|The subjects assigned to interventiongroup2 started with 12 weeks intermittent active and passive training followed by 12 weeks of no intervention (Wash out phase)
15913226|NCT03548961|Drug|FOLFOX regimen|FOLFOX regimen will be administered for 6 cycles. Each cycle is 14 days followed by restaging, local surgery and concurrent chemo radiation therapy
15913227|NCT03548948|Other|High heme iron diet|"A Typical American diet with high heme/non-heme iron (18 mg total). Diet is isocaloric and has a macronutrient composition of total fat 35%, carbohydrates 50%, protein 15% of calories and fiber 9g/1000 calories. Subjects consumes the diet for 3 weeks with a minimum 3 week washout before the next diet."
15913228|NCT03548948|Other|Low iron diet|"A Typical American diet with low heme/non-heme iron (8 mg total). Diet is isocaloric and has a macronutrient composition of total fat 35%, carbohydrates 50%, protein 15% of calories and fiber 9g/1000 calories. Subjects consumes the diet for 3 weeks with a minimum 3 week washout before the next diet."
15913229|NCT03548948|Other|Plant-based high non-heme iron diet|"A plant-based diet with high non-heme iron (18 mg total). Diet is isocaloric and has a macronutrient composition of total fat 35%, carbohydrates 50%, protein 15% of calories and fiber 9g/1000 calories. Subjects consumes the diet for 3 weeks with a minimum 3 week washout before the next diet."
15913230|NCT03548935|Drug|Semaglutide|Participants will receive semaglutide subcutaneous (s.c.; under the skin) injection(s) once-weekly as well as diet and physical activity counselling for 68 weeks. Dose escalation of semaglutide will take place as follows: 0.25 mg from week 1 to 4, 0.5 mg from week 5 to 8, 1.0 mg from week 9 to 12, 1.7 mg from week 13 to 16 and 2.4 mg from week 17 to week 68.
15913231|NCT03548935|Drug|Placebo (semaglutide)|Participants will receive semaglutide matching placebo s.c. injection(s) once-weekly as well as diet and physical activity counselling for 68 weeks.
15913232|NCT03548922|Other|Tanner stage|a scale of pubertal development in children, adolescents
15913233|NCT03548922|Other|Risser stage|a measure showing the growth left in the spine
15913234|NCT03548922|Other|Pressure of correction|an indirect parameter of the chest wall's flexibility. It is defined as the pressure applied to the patient, in the most protruding area of the chest, needed to accomplish a proper shape of the thorax.
15913235|NCT03548922|Other|Pectus carinatum protrusion|distance from the point of maximum protrusion to the estimated normal level of chest wall
15913236|NCT03548909|Diagnostic Test|VITROS Immunodiagnostic Products|NT-proBNP II assay
15913237|NCT03548896|Procedure|Post extraction socket|**Dental implant will be placed 3 months after tooth extraction
15913238|NCT03548870|Other|CWRT with low frequency transcutaneous electrical nerve stimulation|"4 self adhesive surface electrodes will be positioned by pair on quadriceps. Patients will have a low frequency TENS for 20 min at rest. During this period, intensity will be increased every 5 minutes to the maximum tolerated by the patient (below pain threshold, sensation strong but comfortable). Thereafter, intensity is not increased anymore during the test.
~Current characteristics : Rehab 400, CefarCompex 5Hz 200 µs frequency bidirectional"
15913239|NCT03548870|Other|CWRT with sham-low frequency transcutaneous electrical nerve stimulation|4 self adhesive surface electrodes are positioned by pair on quadriceps. Patients will have a sham-low frequency TENS for 20 min at rest. During this period, intensity will be increased for 1 minute to the maximum tolerated by the patient. After this procedure, intensity will be progressively setted back to 1mA. Current characteristics : Rehab 400, CefarCompex 5Hz 200 µs frequency bidirectional
15913240|NCT03548857|Other|Lung transplantation|Single or double lung transplantation in patients with COPD
15913241|NCT03548844|Procedure|local excision|Pathologically verified ypT0-1cN0 rectal cancer patients after local excision are randomized to observation (local excision group) .
15913242|NCT03548844|Procedure|total mesorectal excision|Pathologically verified ypT0-1cN0 rectal cancer patients after local excision are randomized to complementary rectal excision (total mesorectal excision group).
15913243|NCT03548818|Drug|Interferon Gamma-1B|Study function and biochemistry of neutrophils off the drug for one week and then 12 hours after first dose and fourth dose.
15913244|NCT03548805|Procedure|ologen® Collagen Matrix|Ologen is a collagen matrix used to modulate wound healing in the postoperative period to promote diffuse blebs
15913245|NCT03548805|Procedure|Trabeculectomy with low dose mitomycin C|Trabeculectomy with low dose MMC
15913246|NCT03548792|Radiation|RSA radiostereometric analysis|Tantalum beads will be inserted in polyethylene Component and in bone to assess micromotion of Components in radiographs
15913247|NCT03548792|Behavioral|Clinical comparison|ActivePAL, walking speed
15913279|NCT03548493|Drug|Fentanyl|Fentanyl will be given to the active comparator group in a dose of 1 μg /kg IV bolus over 15 minutes followed by continuous infusion starting at 0.5 μg /kg/h
15913650|NCT03545828|Diagnostic Test|Multi-channel aEEG monitoring|18 channel aEEG monitoring in comatose TTM-treated patients
15913248|NCT03548779|Behavioral|Pre-visit prep|Patient and provider surveys will be used to measure the impact of pre-visit preparation on the primary outcomes of engagement of participants in the clinical interaction and their view of the interaction as patient-centered, in addition to secondary outcomes that may be affected by this intervention (described above). The study investigators will test the hypothesis that patients will benefit from pre-visit preparation by: (1) rating their clinical encounters as more patient-centered and (2) asking more questions during their clinical encounters.
15913249|NCT03548779|Diagnostic Test|usual care + exome seq|Provider surveys will be used to assess impact of exome sequencing on diagnostic thinking and management planning. Health utilization and condition-specific general clinical outcomes will be assessed from health records data.
15913250|NCT03548766|Biological|Homologous Blood Transfusion|Homologous, or allogenic, blood transfusions involves someone collecting and infusing the blood of a compatible donor into him/herself.
15913251|NCT03548766|Biological|Autologous Blood Transfusion|Autologous blood transfusion is the collection and re-infusion of the patient's own blood or blood components.
15913252|NCT03548740|Biological|Human Papillomavirus|women with high-risk Human Papillomavirus or not
15913253|NCT03548727|Diagnostic Test|PET/CT Imaging|PET/CT Imaging of tumor hypoxia and proliferation
15913254|NCT03548714|Drug|PT150|Intervention 1 includes PT150 with alcohol consumption
15913255|NCT03548714|Other|Beverage|Alcohol beverage will be prepared by an in-house pharmacist at the MEDVAMC in a volume of 450 ml for a 70 kg individual and adjusted for body weight by varying the volume. Alcohol will be administered in a concentration of 16% alcohol (Everclear, St. Louis, MO) by volume in grape Kool-Aid (Kraft Foods, Northfield, IL). Placebo will be prepared in the same manner but contain 1% alcohol to mask taste.
15913256|NCT03548701|Diagnostic Test|Thromboelastometry testing|Thromboelastometry testing - a form of testing in whole blood for coagulation abnormalities
15913257|NCT03548675|Drug|TCA treatment|All patients fulfilling inclusion criteria will be genotyped for CYP2C19 and CYP2D6 genes. Based on the genetic test results patients will be classified into a metabolisation phenotype (UM, EM, IM or PM).
15913258|NCT03548662|Biological|Platelet-Rich Plasma|Platelet-Rich Plasma prepared by RegenKit® PRP, Regenlab SA
15913259|NCT03548662|Drug|Hyaluronic Acid|Hyruan Plus Inj. produced by LG Life Sciences, Ltd.
15913260|NCT03548662|Other|Exercise|passive range of motion (PROM) exercise, active-assisted range of motion (AAROM) exercise, active range of motion (AROM) exercise, rotator cuff strengthening exercise, and peri-scapular muscle strengthening exercise
15913261|NCT03548649|Device|exoskeleton robot training|subjects will learn to independently use the exoskeleton robot to perform functional activities (including stand-up, sit-down, stepping forward, and walking).
15913262|NCT03548636|Behavioral|Single-Arm Feasibility Study|Groups of 8 to 12 participants, consisting of >50% breast cancer survivors, were invited to apply for up to $2000 to enable access to equipment, resources, facilities, instruction and/or transportation to implement a physical activity intervention. Applicants were assessed by a Grant Review Panel. Successful applicants were informed that they would receive an additional $500 incentive if they increased their group's mean physical activity at six month follow-up (assessed via accelerometry).
15913263|NCT03548610|Other|Nanofat-seeded biological scaffold on surgical defect|Nanofat-seeded biological scaffold in healing larger surgical defects (>1.5cm) involving the lower limbs
15913264|NCT03548597|Device|Evaluation of the Diagnostic of Hepatic Fibrosis With the XL Probe of the Fibroscan Versus Biopsies in Severe Obese Patients Candidates to Bariatric Surgery|Evaluation of the Diagnostic of Hepatic Fibrosis With the XL Probe of the Fibroscan Versus Biopsies in Severe Obese Patients Candidates to Bariatric Surgery
15913265|NCT03548584|Drug|Brexpiprazole|Tablet
15913266|NCT03548584|Other|Placebo|Tablet
15913267|NCT03548571|Biological|Dendritic cell immunization|Intradermal injection
15913268|NCT03548571|Drug|Adjuvant temozolomide|After a 4-week break, patients were then to receive up to six cycles of adjuvant temozolomide according to the standard 5-day schedule every 28 days at 150 mg per square meter for the first cycle and thereafter increase to 200 mg per square meter beginning with the second cycle.
15913269|NCT03548558|Behavioral|Group sessions|"Mother-child dyads in Arm 1 households will receive biweekly ECD sessions for a total of 16 sessions over 7 months. CHVs will record attendance at each session. To maximize participation, prior to each session the CHVs will send a short message service (SMS) mobile phone reminder of the session's topic, time and location to all participants.
~After the end of the 16 biweekly sessions, we will re-randomize across the 40 intervention villages, stratified by Arms 1 and 2, and half of each of Arm 1 and Arm 2 villages will receive bimonthly booster visits for the period between end-line and follow-up surveys."
15913270|NCT03548558|Behavioral|Group+Home sessions|"Households in Arm 2 will receive a total of 16 sessions with identical content similar to Arm 1, but 4 of those sessions will replace group sessions held at the level of villages for personalized home visits, in which the CHV will visit each participant household to deliver these sessions. These home visits will cover identical material and topics as the group sessions in Arm 1 villages, but will be delivered on a personalized basis in the home of the mother and child. Personal barriers to the practices will be discussed and an active resolution strategy developed in concert with the CHV.
~After the end of the 16 biweekly sessions, we will re-randomize across the 40 intervention villages, stratified by Arms 1 and 2, and half of each of Arm 1 and Arm 2 villages will receive bimonthly booster visits for the period between end-line and follow-up surveys."
15913271|NCT03548545|Device|tDCS|subjects will receive a total of 8-structured CBT sessions administered by a certified therapist(according to the NICE guidelines).In the first two weeks, participants will undergo 6-sessions of CBT every other day(3 CBT sessions per week) and 10 daily sessions of either active or sham tDCS(2 mA, 30 minutes).They will undergo additional booster sessions of the same intervention(active or sham tDCS followed by CBT) by week 4 and 6.
15913272|NCT03548532|Device|G210 incubator|very stable culture temperature, up to 0.1°C, in both arms
15913273|NCT03548519|Behavioral|MCAT-only|Mouse-gaze contingent Attention Training without prior psychoeducation
15913274|NCT03548519|Behavioral|MCAT-sham|Placebo version of Mouse-gaze contingent Attention Training without prior psychoeducation
15913275|NCT03548519|Behavioral|MCAT-combo|Mouse-gaze contingent Attention Training with prior psychoeducation
15913276|NCT03548506|Device|Omnidirectional Deep Brain Stimulation of STN|Deep Brain Stimulation
15913280|NCT03548493|Drug|Propofol|In both groups Fentanyl and magnesium sulphate will be accompanied by IV propofol at a dose of 50- 150 μg /kg) bolus over 15 minutes to achieve target sedation level, that is Ramsay sedation scale (RSS) 3,if RSS afterwards does not reach 3, a supplementary bolus dose of 0.2 mg/kg propofol will be given to the patients, followed by ( 20-40 μg /kg/ min) to maintain Intraoperative level of sedation by bispectral index (BIS ) reading by 60-80%
15913281|NCT03548480|Dietary Supplement|Placebo|Intervention with a daily dose of placebo
15913282|NCT03548480|Dietary Supplement|Probiotic|Intervention with a daily dose of probiotic
15913283|NCT03548467|Biological|VB10.NEO|VB10.NEO is a vaccine and is supplied as a sterile, ready to use solution (14 vaccinations will be given).
15913284|NCT03548467|Drug|Bempegaldesleukin|0.006 mg/kg bempegaldesleukin (NKTR-214) will be administered intravenously q4w for up to 11 doses starting from week 11 or at any dosing visit up to week 34 and for up to week 50 (up to 11 doses). The first 2 doses will be in a Q3W interval and following doses in Q4W intervals.
15913285|NCT03548454|Drug|Duloxetine|Open label prescription
15913286|NCT03548454|Drug|Desipramine|Open label prescription
15913287|NCT03548441|Procedure|Surgery|Patients receiving surgical treatment undergo various types of posterior decompressive surgery with or without spinal fusion. The method used for decompressive surgery or fusions is determined solely by the surgeon.
15913288|NCT03548441|Other|Non-surgical management|Patients managing lumbar spinal stenosis non-surgically are either referred to rehabilitation primary health care center or referred back to their general practitioner for treatment. Treatment may include physiotherapy, chiropractic treatment, lifestyle changes and/or pain management. Post-surgically patients may also be referred to rehabilitation at a primary health care center.
15913289|NCT03548428|Drug|Atezolizumab|1200mg IV every 3 weeks for 4 months
15913290|NCT03548428|Radiation|SBRT|3 to 5 fractions depending on tumor size
15913291|NCT03548415|Drug|IONIS-GHR-LRx|Single Dose of IONIS GHR-LRx administered subcutaneously once every 28 days for 16 weeks
15913292|NCT03548415|Drug|Placebo|Placebo (sterile saline 0.9%) Calculated volume to match active comparator administered subcutaneously every 28 days for 16 weeks
15913293|NCT03548402|Behavioral|Acceptance and Commitment Therapy (ACT)|ACT is based on the theory that rigid attempts to control internal states, thoughts and feelings, and other forms of experiential avoidance contribute to symptom development and maintenance of anxiety and self-injury.
15913294|NCT03548389|Other|Skin to skin contact|By assistance of the researcher, intervention infants were placed undressed in a prone position against their mothers' bare chest between breasts immediately after birth and before placental delivery and suturing of tears or episiotomy. The Apgar score was determined, the infant's nose and mouth were suctioned while on the mother's chest, it was well dried, and both mother and infant were covered with a pre-warmed blanket. To prevent heat loss, the infant's head was covered with a dry cap that was replaced when it became damp. Dressing and measuring of the infant were postponed to an hour after the delivery by registered midwife.
15913295|NCT03548376|Other|Hippotherapy|Hippotherapy is a therapeutic intervention that is typically conducted by a physical or occupational therapist and is aimed at improving impaired body function. Hippotherapy has been proposed as a technique to decrease the energy requirements and improve walking in patients with cerebral palsy. It is thought that the natural swaying motion of the horse induces a pelvic movement in the rider that simulates human ambulation. In addition, variations in the horse's movements can also prompt natural equilibrium movements in the rider.
15913296|NCT03548363|Dietary Supplement|Gingest powdered extract obtained from Ginger rhizomes|"Description: Powdered extract obtained from Ginger rhizomes. Botanical name: Zingiber officinale Roscoe Plant part used: Dried rhyzome Extraction solvent: CO2 Extract Ratio 45-60 / 1 100mg of extract are equivalent to an average of 4400 mg of dry ginger rhizomes
~Composition: Natural extract, Calcium Hydroxide, Polysorbate 80, De-oiled soya lecithin, Calcium silicate"
15913297|NCT03548363|Dietary Supplement|Placebo|200 mg/d maltodextrin
15913298|NCT03548350|Behavioral|HealthyKidz physical activity programme|A 24 week physical activity intervention to promote fitness and wellbeing in primary schools
15913299|NCT03548337|Biological|13vPnC|13vPnC MultiDose Vial with preservative compared to a Prefilled syringe containing 13vPnC without any preservative
15913300|NCT03548324|Device|HHHFNC|Application to HHHFNC to treat respiratory distress syndrome in preterm infants previously demonstrated to be stable on a non-invasive respiratory support (HHHFNC or NCPAP).
15913301|NCT03548324|Device|NCPAP|Application to NCPAP to treat respiratory distress syndrome in preterm infants previously demonstrated to be stable on a non-invasive respiratory support (HHHFNC or NCPAP).
15913302|NCT03548311|Drug|methylcobalamin|Patients receive methylcobalamin 50mg intramuscular injection twice a week.
15913303|NCT03548311|Drug|saline solution|Patients receive saline solution intramuscular injection twice a week.
15913304|NCT03548298|Procedure|ARAT|After confirmation of GERD, participants will undergo to ablation with Hybrid-APC (ARAT). Participant will be admitted to hospital 24 hrs before procedure. Technique consist in ablation with hybrid-APC, submucosal injection of saline solution with methylene blue at 3-4 cm from 60-70% cardias and 1 cm esophageal. After procedure they will be kept on surveillance and will be followed-up with clinical, endoscopic, esophageal manometry and pHmetry up to 1 year after procedure.
15913305|NCT03548285|Radiation|Radiation therapy|Stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiation therapy (SBRT)
15913306|NCT03548272|Procedure|Percutaneous Coronary Intervention with stent implantation|PCI with BiOSS LIM C or rDES depending on the randomization
15913307|NCT03548259|Procedure|Platelet-rich plasma|Platelet-rich plasma injection
15913308|NCT03548259|Procedure|Platelet-poor plasma|Platelet-poor plasma injection
15913309|NCT03548246|Drug|Abiraterone acetate|Daily oral abiraterone acetate for 2 years. The dose will be specified based on pharmacodynamic data from Phase 1.
15913310|NCT03548246|Drug|Placebo|Daily placebo for 2 years.
15913311|NCT03548246|Drug|Hydrocortisone|Hydrocortisone will be administered at a starting dose of 7-9 mg/M2/d and adjusted as necessary based on 17-hydroxyprogesterone and ACTH levels.
15913312|NCT03548246|Drug|Fludrocortisone|Fludrocortisone will be administered at the dose the subject was taking a study entry and adjusted as necessary to keep plasma renin in the high normal range.
15913313|NCT03548233|Biological|bcg vaccine|live attenuated vaccine
15913314|NCT03548220|Drug|AG-348|"Part 1 (Dose Optimization Period): Participants will begin by receiving 5 milligrams (mg) orally, twice a day. Each participant's dose of AG-348 may be increased to 20 mg twice a day or 50 mg twice a day depending on their response to AG-348 and their tolerance.
~Part 2 (Fixed Dose Period): Last dose received in Part 1, twice daily."
15913315|NCT03548220|Drug|Placebo|"Part 1 (Dose Optimization Period): Participants will begin by receiving placebo matching AG-348 orally, twice a day. Each participant's dose of placebo matching AG-348 may be increased to 20 mg twice a day or 50 mg twice a day depending on their response to the placebo matching AG-348 and their tolerance.
~Part 2 (Fixed Dose Period): Last dose received in Part 1, twice daily."
15913316|NCT03548207|Biological|JNJ-68284528|JNJ-68284528 consist of autologous T lymphocytes transduced with LCAR-B38M, a lentiviral vector to express a chimeric antigen receptor targeting the human B cell maturation antigen (anti-BCMA CAR).
15913317|NCT03548194|Drug|BNC210|BNC210 300 mg b.i.d
15913318|NCT03548194|Drug|Placebo|Placebo b.i.d.
15913319|NCT03548181|Behavioral|Virtual Autonomous Physiotherapist Agent (VAPA)|A Virtual Autonomous Physiotherapist Agent is going to gide and motivate the patient to train physically at home.
15913320|NCT03548155|Drug|Berberine|Berberine 300mg（three times a day） plus any atypical antipsychotic drug
15913321|NCT03548155|Drug|atypical antipsychotic|Any atypical antipsychotic drug as the basic treatment
15913322|NCT03548155|Drug|placebo|The placebo were matched to Berberine in shape, smell and colour and capsules were sealed in identical bottles
15913323|NCT03548142|Behavioral|provision of relevant information|caregivers are provided with brochure that informs about end-of-life issues for persons with advanced dementia
15913324|NCT03548129|Drug|phosphomycin|Single dose 3 gm oral fosfomycin will be taken by mouth on an empty stomach
15913325|NCT03548129|Drug|Culture specific antibiotic therapy|Culture-specific antibiotic treatment for 5 days
15913326|NCT03548129|Diagnostic Test|Pre-treatment Urine Culture|Mid-stream urine sample will be cultured and number of CFU per mL will be determined.
15913327|NCT03548129|Diagnostic Test|Antimicrobial sensitivity testing|Susceptibility of urinary pathogens to various antimicrobials
15913328|NCT03548129|Diagnostic Test|Post-treatment urine culture|Mid-stream urine sample will be cultured and number of CFU per mL will be determined.
15913329|NCT03548116|Device|Ultrasound|This study involves a specially designed ultrasound being placed against the abdomen of an individual in order to administer low levels of insonification to the spleen as specified by the individual's assigned study group.
15913330|NCT03548116|Device|Sham Ultrasound|This study involves a specially designed ultrasound being placed against the abdomen of an individual in order to administer sham insonification to the spleen as specified by the individual's assigned study group.
15913331|NCT03548103|Dietary Supplement|Green tea extract|Green tea extract 500 mg tid for 16 weeks
15913332|NCT03548103|Dietary Supplement|Placebo|Placebo tid for 16 weeks
15913333|NCT03548090|Other|Skateboard exercise at an incline angle of 0 degrees and 50% body weight|Participants will stand on a specified incline angle (0 degrees) and with a specified body weight (50%) on the paretic LE and will simultaneously move a small skateboard forward with the non-paretic LE.
15913334|NCT03548090|Other|Skateboard exercise at an incline angle of 5 degrees and 50% body weight|Participants will stand on a specified incline angle (5 degrees) and with a specified body weight (50%) on the paretic LE and will simultaneously move a small skateboard forward with the non-paretic LE.
15913335|NCT03548090|Other|Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 75% body weight|Participants will stand on a specified incline angle (either 0 or 5 degrees, whichever is determined during phase 1 to be optimal) and with a specified body weight (75%) on the paretic LE and will simultaneously move a small skateboard forward with the non-paretic LE.
15913336|NCT03548090|Other|Skateboard exercise at an incline angle determined to be optimal in phase 1 (either 0 or 5 degrees) and 90% body weight|Participants will stand on a specified incline angle (either 0 or 5 degrees, whichever is determined during phase 1 to be optimal) and with a specified body weight (90%) on the paretic LE and will simultaneously move a small skateboard forward with the non-paretic LE.
15913337|NCT03548090|Other|Control 4-week exercise intervention|This intervention occurs in phase 3. Subjects will participate in 1-hour sessions three times per week for four weeks. The control group will perform three sets of ten repetitions of the following 4 exercises, for a total of 120 repetitions: 1) standing hip abduction against green theraband resistance with upper extremity support, 2) sit to stands from chair with no upper extremity support, 3) bilateral calf raises with upper extremity support, and 4) right and left weight shifting exercises using a wobble board with upper extremity support available if needed.
15913338|NCT03548090|Other|Experimental 4-week exercise intervention|This intervention occurs in phase 3. Subjects will participate in 1-hour sessions three times per week for four weeks. The experimental group will perform the skateboard exercise with the optimal parameters established during studies 1 and 2 (that is, an incline angle of either 0 or 5 degrees and a body weight percentage of 50%, 75%, or 90%)--the forward and backward speed of the skateboard will be cued with a metronome that will set at a beats per minute that matches the foot strike cadence of someone walking at 0.7 m/s, and the magnitude of forward excursion of the skateboard will be individualized to the participant based on GAITRite® data (that is, step length of the non-paretic LE).
15913339|NCT03548090|Other|Over-ground multi-directional gait training|In the over-ground multi-directional gait protocol, the participant will walk 750 steps forward, 50 steps backward, and 200 side steps over level surfaces. The over ground gait training will focus on equalizing step length while performing multi-directional gait training.
15913340|NCT03548090|Other|Home exercise|Home exercise consists of three sets of ten repetitions of the following three exercises to be performed on non-therapy days over the four weeks of phase 3: 1) sit to stands from chair with no upper extremity support, 2) bilateral calf raises with hand support, and 3) resisted side stepping to the non-paretic side using a green theraband with upper extremity support.
15913341|NCT03548077|Behavioral|POWERPLAY|"All men from participating worksites are invited to completed surveys prior to and following implementation of a workplace wellness program (called POWERPLAY)"
15913342|NCT03548064|Other|Placebo|Placebo
15913343|NCT03548064|Other|Placebo|Placebo
15913344|NCT03548064|Other|Placebo|Placebo
15913467|NCT03547245|Biological|eOD-GT8 60mer + AS01B/ DPBS sucrose/IM|20 μg
15913345|NCT03548064|Biological|Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine|LT(R192G/L211A), or dmLT is a derivative of wild-type enterotoxigenic Escherichia coli heat-labile enterotoxin that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules.
15913346|NCT03548064|Biological|Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine|LT(R192G/L211A), or dmLT is a derivative of wild-type enterotoxigenic Escherichia coli heat-labile enterotoxin that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules.
15913347|NCT03548064|Biological|Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine|LT(R192G/L211A), or dmLT is a derivative of wild-type enterotoxigenic Escherichia coli heat-labile enterotoxin that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules.
15913348|NCT03548051|Procedure|Fecal Microbiota Transplantation (FMT)|100 grams of thawed processed stool diluted into 250 ml of saline and delivered by retention enema
15913349|NCT03548051|Drug|Saline|250 ml of saline delivered by retention enema
15913350|NCT03548038|Other|taste test|All subjects will complete a procedure to determine their taste sensitivity to sweet tastants.
15913351|NCT03548025|Device|BTL-703 (Treatment group)|Treatment with BTL-FR2000 Device
15913352|NCT03548012|Behavioral|The Carer Support Needs Assessment Tool (CSNAT) intervention|The CSNAT intervention is a caregiver-led approach where the caregiver first identifies his/her needs of support in the CSNAT, which consists of 14 support domains. Then the practitioner facilitates the intervention where the caregiver prioritizes which domains to discuss. In the conversation, the caregiver's domain priorities and subsequently identified support needs are discussed with the practitioner to agree on actions/solutions and a shared action plan. The intervention will be offered each caregiver twice: the first time between 0 and 13 days after enrollment, and the second time between 15 and 27 days after enrollment.
15913353|NCT03547999|Drug|mFOLFOX6|The control arm (Arm A) and experimental arm (Arm B) will receive mFOLFOX6 every 2 weeks for 4 cycles. Once patients in the post-operative period are deemed ready to begin therapy, patients in the control arm will then undergo another 8 cycles of mFOLFOX6.
15913354|NCT03547999|Biological|MVA-BN-CV301|The experimental arm (Arm B) will receive MVA-BN-CV301 in 4 injections of 4 x 10(8) infectious units/0.5 mL given subcutaneously prior to the start of chemotherapy on days -28 and -14.
15913355|NCT03547999|Biological|FPV-CV301|The experimental arm (Arm B) will receive FPV-CV301 in 1 dose of 1 x 10(9) infectious units/0.5 mL given subcutaneously concurrently with chemotherapy (at least an hour prior to chemotherapy) on days 0, 14, 28 and 42 pre-operatively, and FVP-CV301 boosters on day 0 and 14 and then every 4 weeks (day 42, 70, 98). After day 98, FVP-CV301 will then be administered every twelve weeks completing therapy at week 110.
15913356|NCT03547999|Drug|Nivolumab|Nivolumab at a dose of 240 mg as a 30 minute IV infusion every 2 weeks until progression. Arm B will receive Nivolumab starting with the vaccinations. Arm A will begin the Nivolumab with the initiation mFOLFOX.
15913357|NCT03547986|Diagnostic Test|Duplex Ultrasound (DUS)|Occurrence of a flow-limiting dissection or residual stenosis will be assessed by standard angiography and Duplex Ultrasound
15913358|NCT03547986|Diagnostic Test|IVUS with Intraarterial pressure measurement (IAP) if needed|Occurrence of a flow-limiting dissection or residual stenosis will be assessed by standard angiography and Intra-vascular ultrasound associated to Intraarterial pressure measurement if needed
15913363|NCT03547960|Dietary Supplement|Guar gum|Fibre supplement to be taken with each meal
15913364|NCT03547960|Dietary Supplement|Cellulose|Placebo. Fibre supplement to be taken with each meal
15913365|NCT03547947|Device|Medacta Shoulder System|Total Shoulder Arthroplasty
15913366|NCT03547934|Device|High Intensity Focused ElectroMagnetic system.|The treatment administration phase will consist of four (4) treatments, delivered twice a week. The applicator will be applied over the abdomen area. Visible contractions will be induced by the device.
15913367|NCT03547921|Device|iu22 ultrasound system - phillips|iu22 ultrasound system - phillips
15913368|NCT03547908|Drug|B/F/TAF|50/200/25 mg B/F/TAF FDC tablet administered orally once daily, without regard to food
15913369|NCT03547908|Drug|Placebo to match DTG|Tablet administered orally once daily, without regard to food
15913370|NCT03547908|Drug|Placebo to match F/TDF|Tablet administered orally once daily, without regard to food
15913371|NCT03547908|Drug|DTG|50 mg tablet administered orally once daily, without regard to food
15913372|NCT03547908|Drug|F/TDF|200/300 mg tablet administered orally once daily, without regard to food
15913373|NCT03547908|Drug|Placebo to match B/F/TAF|Tablet administered orally once daily, without regard to food
15913374|NCT03547895|Drug|Sofosbuvir 400mg (Sovaldi) + Daclatasvir 60 mg (Daklinza) + Ribavirin 200 mg (Rebetol)|sofosbuvir 400mg+ribavirin 400mg+daclatasvir 60 mg were adminstered for 3 months
15913375|NCT03547895|Drug|vitamin K (Phytomenadione) 10 mg+ furosemide and spironolactone (Lasilactone) 50 mg + milk thistle (Silymarin) 140 mg + Albumin infusion|symptomatic therapy for liver support, control of ascites and bleeding tendency.
15913376|NCT03547869|Device|Active tDCS|Active tDCS will be adminestered
15913377|NCT03547869|Device|Sham tDCS|Sham tDCS will be administered
15913378|NCT03547843|Behavioral|Group-based education|The group-based educational program consists of two sessions that run over two consecutive weeks. Each session consists of a lecture from a recruited expert on the topic of the session and by expert patients with a following discussion of the topic facilitated by the course leader.
15945281|NCT03300609|Biological|Panitumumab|Given IV
15913379|NCT03547843|Behavioral|Waiting list|No educational intervention for the duration of the 10 weeks. During this period participants can receive standard treatment.
15913380|NCT03547843|Other|Standard treatment|Diagnostic treatment with medication. In addition, some patients receive cognitive behavioral therapy (not systematically given to every patient). If needed, patients are also offered assistance with regard to economy, housing, education, and work as well as contact with family and network.
15913381|NCT03547830|Drug|Plerixafor|Plerixafor for Conditioning before HSCT.
15913382|NCT03547830|Drug|Gcsf|GCSF for Conditioning before HSCT.
15913383|NCT03547817|Device|Intermittent negative pressure device|Pressure levels of 0 mmHg, -10 mmHg, -20 mmHg, -40 mmHg and -60 mmHg will be tested, with washout periods of 5 minutes between the different pressure levels
15913384|NCT03547804|Drug|Apatinib|500 mg qd/250mg
15913385|NCT03547804|Drug|chemotherapy|Chemotherapeutic agents are limited to irinotecan or docetaxel alone.
15913386|NCT03547791|Drug|Betamethason Sodium Phosphate|The antecorticosteroid that will be administered to Group 1 is betamethasone, produced by Dawon Parm(Korea). It contains betamethason sodium phosphate 5.2mg(Betamethasone 4.0mg) in 1 ample(1mL). Each drug is carried in a syringe by pharmacist who does not participate in study after the patient was enrolled in the study and administered to the patient twice 24hours apart.
15913387|NCT03547791|Drug|Normal saline|Intramuscular injection of normal saline 3ml twice 24hours apart
15913388|NCT03547778|Drug|Misoprostol 50 mcg pesssary|Participants in the study arm will receive vaginal misoprostol (50 mcg) to be inserted the night before the procedure. Whereas the control group will get a placebo.
15913389|NCT03547778|Drug|Placebos|The control group will receive placebo pessaries to be inserted vaginally the night before the procedure.
15913390|NCT03547752|Other|observed action and motor imaginery|Observation of a video of neck movement and imagination of the same observed movement, feeling the realization of the movement but not developing it.
15913391|NCT03547739|Behavioral|Home visits|If a couple has been randomized to the home visit intervention arm, a lay health worker will obtain detailed locator information (including cell phone contacts) and consult with the couple about optimal times for a home visit. As described above, the intervention arm will consist of five home visits conducted by one female and one male lay health worker, including two home visits during pregnancy, one at six weeks after the birth, and two booster sessions, one at six months after the birth and one at 12 months after the birth. Home visits are designed for all pregnant couples (regardless of woman's initial HIV test result at the antenatal clinic) and include topics important for maternal, paternal, and child health during pregnancy and postpartum.
15913392|NCT03547739|Behavioral|HIV Self-testing|Women in this study group will receive oral-fluid-based rapid HIV test kits for themselves and their male partner at up to 4 time points (twice during pregnancy and twice postpartum). Each test will be accompanied with a self-testing instruction sheet describing step-by-step procedures in multiple languages. Study staff will also conduct a brief demonstration on how to use the tests. Participants will be encouraged to offer a test kit to their male partner or to undertake couples testing. They will also be counseled on how to talk to their partners and the possibility of adverse partner reactions. Participants will be instructed to seek clinic-based confirmatory testing if a reactive self-test result is obtained.
15913393|NCT03547726|Other|Physical Therapy|These patients will receive a formal physical therapy protocol by seeing a physical therapist in clinic.
15913394|NCT03547726|Other|Self-Rehab|These patients will be provided with a list of actions NOT to perform and allowed to self rehabilitate. They will not see a physical therapist.
15913395|NCT03547713|Behavioral|Social feedback|Social feedback regarding performance of a public speech is delivered to participants
15913396|NCT03547713|Behavioral|Self-referential paradigm|Exposure to traits varying in valence (positive vs. negative) and social domain (power vs. affiliation)
15913397|NCT03547713|Behavioral|Reward vs. punishment task|Reception of monetary gains vs. losses
15913398|NCT03547713|Behavioral|Emotional reactivity task|Exposure to emotional faces vs. shapes
15913399|NCT03547700|Drug|Romidepsin|Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression.
15913400|NCT03547700|Drug|Ixazomib|Ixazomib is a reversible proteasome inhibitor. Ixazomib preferentially binds and inhibits the chymotrypsin-like activity of the beta 5 subunit of the 20S proteasome.
15913401|NCT03547687|Device|Electrical Stimulation Treatment|"An Intelect Neuromuscular Electrical Stimulator (NMES) (Chattanooga Group) device will be used to provide the stimulation. The stimulator will be set up and taken off the patients by a member of the study team or a trained ICU staff member. The stimulation parameters will be as follows:
~Electrode location: Proximal and distal quadriceps Waveform: pulsed biphasic Pulse duration: 300 microseconds Pulse frequency: 35 pulses per second Amplitude: palpable, visible quadriceps muscle contraction On/off time: 5 seconds on, 15 seconds off Ramp up and down time: 2 seconds each"
15913402|NCT03547687|Device|Neuromuscular Electrical Stimulation Treatment|"If a muscle contraction is not produced with the Intelect NMES portable device, the Vectra Neo Clinical Therapy System (Chattanooga Group) device will be used instead. The stimulator will be set up and taken off the patients by a member of the study team or a trained ICU staff member. The stimulation parameters will be as follows:
~Electrode location: Proximal and distal quadriceps Waveform: pulsed biphasic Pulse duration: 300 microseconds Pulse frequency: 35 pulses per second Amplitude: palpable, visible quadriceps muscle contraction On/off time: 10 seconds on, 30 seconds off Ramp up and down time: 2 seconds each"
15913403|NCT03547674|Other|barefoot|Gait analysis under 4 conditions (barefoot, shoes only, untuned AFO with shoes, tuned AFO with shoes) will be performed in a random order.
15913404|NCT03547674|Other|shoes only|Gait analysis under 4 conditions (barefoot, shoes only, untuned AFO with shoes, tuned AFO with shoes) will be performed in a random order.
15913405|NCT03547674|Other|untuned AFO with shoes|Gait analysis under 4 conditions (barefoot, shoes only, untuned AFO with shoes, tuned AFO with shoes) will be performed in a random order. AFO are walking aids to improve gait pathologies. They are custom-built using plaster casts. AFO for equinus and/or drop foot pathologies are specifically indicated to control excessive ankle plantar flexion. Push-up elements that return the energy from the stance-phase to support lifting the foot during the swing-phase (similar to a spring) are used.
15913468|NCT03547245|Biological|eOD-GT8 60mer + AS01B/ DPBS sucrose/IM|100 μg
15913406|NCT03547674|Other|tuned AFO with shoes|Gait analysis under 4 conditions (barefoot, shoes only, untuned AFO with shoes, tuned AFO with shoes) will be performed in a random order. Modular AFO tuning means that patients try different pushup elements with varying stiffness and design before the final design is determined.
15913407|NCT03547661|Other|P-Dragees rosa Lichtenstein|Placebo dragées
15913408|NCT03547648|Procedure|peak airway pressure|Patients' peak airway pressures will be raised to observe intraoperative bleeding in thyroidectomy surgery. Aim is to prevent postoperative bleeding.
15913409|NCT03547635|Other|AMNIOEXCEL Plus Amniotic Membrane|AMNIOEXCEL Plus is a human placental-based tissue consisting of dehydrated, tri-layer Placental (Amnion/Chorion/Amnion) Allograft Membrane (T-PAM) layers. T-PAM is a minimally manipulated placental membrane product made from tissues donated by pre-screened mothers during planned C-sections and is intended for use as a wound covering. This product is an allograft tissue intended for homologous use for the repair, reconstruction and replacement of skin at the direction of a physician. AMNIOEXCEL Plus contains Human Cellular and Tissue Based Products (HCT/P) as defined by US FDA 21 CFR Part 1271. All donor recoveries are performed by BioDlogics, LLC, and adhere to the regulations regarding HCT/P recovery and the screening and testing of the tissue donor as verified through supplier audits.
15913410|NCT03547635|Device|A Marketed Comparator|bi-layered skin substitute: the epidermal layer is formed by human keratinocytes and has a well-differentiated stratum corneum; the dermal layer is composed of human fibroblasts in a bovine Type I collagen lattice. It is indicated for use with standard therapeutic compression for the treatment of non-infected partial and full-thickness skin ulcers due to venous insufficiency of greater than 1-month duration and which have not adequately responded to conventional ulcer therapy. This product is also indicated for use with standard DFU care for the treatment of full-thickness neuropathic DFUs of greater than three weeks' duration which have not adequately responded to conventional ulcer therapy and which extend through the dermis but without tendon, muscle, capsule or bone exposure.
15913411|NCT03547635|Other|Standard of Care|"Coban™
~Conforming gauze
~Optifoam® non-adhesive dressing
~Cotton Gauze
~Normal saline (liquid or gel)
~Non-adhering dressings
~Steristrips
~An offloading boot (Pneumatic Short Leg Walker), as appropriate"
15913412|NCT03547622|Drug|MAT taper with galantamine|Following taper from MAT (methadone or buprenorphine) participants will be given galantamine daily with access to a CBT4CBT computer program
15913413|NCT03547622|Drug|MAT taper with placebo|Following taper from MAT (methadone or buprenorphine) participants will be given placebo daily with access to a CBT4CBT computer program
15913414|NCT03547609|Other|No arm intervention|No arm intervention
15913415|NCT03547596|Other|questionnaire passation|Questionnaires to evaluate lower urinary tract symptoms and erectile dysfunction.
15913416|NCT03547583|Drug|Vericiguat (BAY1021189) 2.5 mg, 5 mg or 10 mg IR tablets|Oral use. Vericiguat, which will be started at 2.5 mg at randomization and up-titrated to 5 mg at week 2, and to 10 mg at week 4, with sham titration or up-titration to 15 mg at week 6.
15913417|NCT03547583|Drug|Placebo|Placebo and sham up-titration at weeks 2, 4, and 6
15913418|NCT03547570|Other|Progressive heavy shoulder resistance training|The training programme includes five exercises identified in literature to target scapular and rotator cuff muscles.
15913419|NCT03547557|Device|Exablate 2000 strappable system|
15913420|NCT03547531|Other|Natural Tooth Brushing Method|Natural tooth brushing method is the method that is naturally used by the people with horizontal, rotary, or simple up and down motions and any position of the brush without any instruction of particular tooth brushing method.
15913421|NCT03547531|Other|Modified Circular Tooth Brushing Method|Modified Circular tooth brushing method is a combination of small circular motion of brushing with the position of the brush slightly reach underneath the gingival that are applied for each jaw in all facial surfaces and posterior lingual of tooth arches.
15913422|NCT03547518|Device|PTNS treatment|One-week induction consisting of three active PTNS treatments, each 2 hours long
15913423|NCT03547518|Device|Sham treatment|One-week induction consisting of three active PTNS treatments, each 2 hours long
15913424|NCT03547505|Procedure|R-Pilot®|Glide path preparation using R-Pilot® in reciprocating manner.
15913425|NCT03547505|Procedure|ProGlider®|Glide path preparation using ProGlider® in a rotating manner.
15913426|NCT03547505|Procedure|Manual preparation|Glide path preparation using manual K-files numbered from 08 to 15.
15913427|NCT03547492|Behavioral|Teaching Talking|Written packet including 8 lessons: What's My Corrected Age, Watch Me Learn (language milestones in the 1st year of life), Reading Aloud, Sing-a-long: Sleepy Songs, Sing-a-long: Alert Songs, Copying First Sounds, Playing Games, Talk to Your Baby.
15913428|NCT03547492|Behavioral|LENA recordings-language|LENA a special recording device. It records for 16 hours inside a specially designed infant vest. The recording is analyzed by a computer that generates an output of total number of adult words, infant vocalizations and conversational turns during the recording period. 4 LENA recordings are obtained: baseline, after reviewing Teaching Talking and linguistic feedback of first recording, 4 and 12 months of age. Participants are mailed feedback of their 2nd, 4 and 12 month recordings.
15913429|NCT03547492|Behavioral|LENA recordings-motor|LENA a special recording device. It records for 16 hours inside a specially designed infant vest. The recording is analyzed by a computer that generates an output of total number of adult words, infant vocalizations and conversational turns during the recording period. 4 LENA recordings are obtained: baseline, 2nd, 4 and 12 months of age. Participants are mailed feedback on recordings after completing study.
15913430|NCT03547492|Behavioral|Mastering Movement|A written curriculum containing 5 lessons adopted from Beautiful Beginnings: What's My Corrected Age, Watch Me Move! (review of motor milestones in 1st year), Gentle Stretching and Exercise, Tummy Time, Help Me Learn to...
15913431|NCT03547492|Behavioral|Language text messages|12 weekly text messages. Each is 1-2 sentences to review concepts of Teaching Talking
15913432|NCT03547492|Behavioral|Motor text messages|4 text messages sent every 4 weeks. Each is 1-2 sentences reviewing concepts of Mastering Movement
15913433|NCT03547479|Behavioral|VDOT|In VDOT, reminder notifications are sent x minutes prior to the scheduled pill time, and continue every y minutes until the user sends a video of themselves taking their pill via the app. Instructions will be provided in Khmer. The web system has an administrator component whereby a healthcare provider can log in via the Internet to monitor and validate all the videos received that day, and reasons for non-submission.
15913469|NCT03547245|Biological|DPBS Sucrose|Placebo
15913434|NCT03547479|Behavioral|VDOT + mobile money|The VDOT intervention above will be paired with financial incentives in the form of mobile payments in one of the experimental arms.
15913435|NCT03547427|Other|Basal insulin alone|A study insulin pump containing lispro insulin will be programmed to deliver basal lispro insulin at according to the subject's normal basal profile. The carbohydrate ratio(s) and insulin sensitivity factor(s) will be programmed per the subject's usual home parameters.
15913436|NCT03547427|Other|Basal pramlintide and reduced basal insulin|A study insulin pump containing pramlintide will be programmed to deliver pramlintide at 6:1 pramlintide:insulin ratio. Simultaneously, a study insulin pump containing lispro insulin will be programmed to deliver basal lispro insulin at ~25% reduced rate from the subject's normal basal profile. The carbohydrate ratio(s) and insulin sensitivity factor(s) will be programmed per the subject's usual home parameters.
15913437|NCT03547427|Other|CGM|Subjects will be instructed to initiate a Continuous Glucose Monitor (CGM) session 2-3 days prior to both the experimental and control CRU admissions.
15913438|NCT03547427|Other|Acetaminophen test|Consumption of a standardized meal mixed with added 1.5 g liquid acetaminophen
15913439|NCT03547427|Other|Insulin-induced hypoglycemia|During insulin-induced hypoglycemia admission, subjects will receive an insulin bolus(s) dosed to reach blood sugar of less than 55 mg/dL.
15913440|NCT03547427|Other|Exercise-induced hypoglycemia|During exercise-induced hypoglycemia admission, subjects participate in three 15 minute exercise bouts (45 minutes total) to lower blood sugar to less than 55 mg/dL.
15913441|NCT03547414|Other|Nephrocheck test|A fresh urine sample was collected on inclusion (maximum 6 hours after starting catecholamines) through the urine collecting tube and frozen at -80°C. At the end of the study, urine samples were thawed and centrifuged as recommended by the manufacturer and the urinary TIMP2*IGFBP7 concentration was determined using the Nephrocheck™ test. The Nephrocheck™ test simultaneously measures into the Astute 140™ meter (a bench top analyzer) the urinary concentrations of TIMP2 and IGFBP7 on 100 µl of urine mixed with 100 µl of buffer. The result is expressed as a single number corresponding to the product of TIMP2 and IGFBP7 concentrations.
15913442|NCT03547401|Device|Ankle Non-invasive Blood pressure measurement|Non-invasive blood pressure measured simultaneously at the arm (model IntelliVue M8105a MP5 Phillips, calibrated).
15913443|NCT03547401|Device|Arm Non-invasive Blood pressure measurement|Non-invasive blood pressure measured simultaneously at the ankle (model IntelliVue M8105a MP5 Phillips, calibrated).
15913444|NCT03547388|Device|Moderate whole body hyperthermia using water-filtered IR-A-radiation|four to six applications of whole Body hyperthermia concomitant to radiochemotherapy. Additional measurement of Perfusion and hypoxia by 18F-FMISO hypoxia PET and magnetic resonance Imaging
15913445|NCT03547375|Drug|Apatinib|Apatinib 500mg/d po,28 days as one cycle
15913446|NCT03547362|Dietary Supplement|Casein|See arm description
15913447|NCT03547362|Dietary Supplement|Dairy protein blend 1|See arm description
15913448|NCT03547362|Dietary Supplement|Whey protein|See arm description
15913449|NCT03547362|Dietary Supplement|Dairy protein blend 2|See arm description
15913450|NCT03547362|Dietary Supplement|Dairy protein blend 3|See arm description
15913451|NCT03547362|Dietary Supplement|Dairy protein blend 4|See arm description
15913452|NCT03547349|Device|Digital Incentive Spirometer|This device is an incentive spirometer connected to a tablet interface. This tablet device uses a digital interface to mimic the look and function of the standard issue incentive spirometer
15913453|NCT03547349|Device|Jamboxx Respiratory Therapy Device|THe Jamboxx Respiratory Therapy Device is a novel device that uses interactive gaming to encourage patient compliance with their prescribed respiratory therapy routines. The device consists of a computer game controller with mouthpiece, and breath flow sensor that connects to a tablet. With the Jamboxx Respiratory Therapy Device, users can choose from a suite of breath controlled respiratory therapy games to guide them through their routines while receiving real-time feedback, and long-term progress tracking.
15913454|NCT03547336|Device|Theranova 400 Dialyzer|Dialysis performed in HD mode. Treatment duration for each individual subject will vary based on clinical requirements determined by the Investigator, based on the subject's need, residual renal function, access function, tolerance to HD/HDF and other relevant factors. The participating subjects' HD/HDF prescriptions should be kept stable throughout the study.
15913455|NCT03547336|Device|FX800 Dialyzer|Dialysis performed in HDF mode. Treatment duration for each individual subject will vary based on clinical requirements determined by the Investigator, based on the subject's need, residual renal function, access function, tolerance to HD/HDF and other relevant factors. The participating subjects' HD/HDF prescriptions should be kept stable throughout the study.
15913456|NCT03547323|Device|Theranova 400 Dialyzer|An existing functioning vascular access (AVF, graft) must be in place and will be used for dialysis. Treatments will be administered by trained clinical staff. The use of temporary or tunneled dialysis catheters will not be allowed.
15913457|NCT03547323|Device|FX80 Dialyzer|An existing functioning vascular access (AVF, graft) must be in place and will be used for dialysis. Treatments will be administered by trained clinical staff. The use of temporary or tunneled dialysis catheters will not be allowed.
15913458|NCT03547310|Behavioral|MyoBeatz|Training of the patient's muscle coordination, strength and ability to separately contract muscles, while holding up patient motivation. The patient is expected to follow a protocol of 4 weeks of training.
15913459|NCT03547284|Drug|sugarless gum|81 patients will receive 1 stick of sugarless gum(Samara gum) for 15 minutes every 2 hours
15913466|NCT03547258|Genetic|Clinical and Molecular data collection|Clinical and Molecular data collection at diagnosis, during treatment and at each relapse
15913471|NCT03547232|Drug|Placebos|Similar shape and size suppositories (Placebos) without indomethacin given q12h from admission day 1 to day 7
15913472|NCT03547219|Drug|Escitalopram|
15913473|NCT03547206|Drug|RPh201 Cohort A|RPh201 is a proprietary, isolated botanical extract of gum mastic for treatment of nonarteritic anterior ischemic optic neuropathy (NAION).
15913474|NCT03547206|Other|Placebo Cohort A|The placebo is composed of RPh-201 excipients (cottonseed oil stabilized with butylated hydroxytoluene [BHT]).
15913475|NCT03547206|Drug|RPh201 Cohort B|RPh201 is a proprietary, isolated botanical extract of gum mastic for treatment of nonarteritic anterior ischemic optic neuropathy (NAION).
15913476|NCT03547206|Other|Placebo Cohort B|The placebo is composed of RPh-201 excipients (cottonseed oil stabilized with butylated hydroxytoluene [BHT]).
15913477|NCT03547180|Behavioral|Cognitive Therapy|The training included four components: (a) educating patients about exacerbating panic symptoms through catastrophic thoughts (vicious cycle), (b) identifying negative cognitions associated with physical sensation triggers of recent panic attacks, (c) practicing replacement of maladaptive cognitions with non catastrophic explanations, and (d) instructing patients in between session exercises during Phase I.
15913478|NCT03547180|Behavioral|Capnometry-Assisted Respiratory Training|The training included four components: (a) educating patients about the exacerbation of panic symptoms through hypocapnia; (b) directing patients' attention to potentially detrimental respiratory patterns; (c) teaching patients techniques to control their respiration, in particular end-tidal PCO2; and (d) instructing patients in between-session exercises. Between-session exercises using a portable capnometer were to be performed twice a day for 17 min at home or elsewhere during Phase I.
15913479|NCT03547180|Behavioral|In-vivo exposure|In this two-phase intervention, patients were randomized (within each site) to first receive five individual, weekly, 1-hr sessions of respiratory skill training (CART) or cognitive skill training (CT; Phase I, Skill Acquisition Training), followed by three weekly sessions of in-vivo exposure (Phase II, Application Training) plus a fourth session at 2-month follow-up.
15913480|NCT03547167|Biological|V114|15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose
15913481|NCT03547167|Biological|Prevnar 13™|13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg), and aluminum phosphate adjuvant (125 mcg aluminum) in each 0.5 ml dose
15913482|NCT03547167|Biological|PNEUMOVAX™23|23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose
15913483|NCT03547154|Biological|Pegylated interferon alfa-2b|Weekly SC injection of pegylated interferon alfa-2b, 6.0 microg/kg
15913484|NCT03547154|Biological|Interferon alfa-2b|Daily SC injection of interferon alfa-2b, 5 MIU/m^2
15913485|NCT03547141|Drug|MBA-P01|injection of MBA-P01 into the muscle of each contralateral foot in equal doses
15913486|NCT03547141|Drug|BOTOX|injection of BOTOX into the muscle of each contralateral foot in equal doses
15913487|NCT03547115|Drug|voruciclib|Voruciclib is provided as 50 mg and 100 mg capsules and is administered orally once a day
15913488|NCT03547102|Dietary Supplement|Cherry concentrate|
15913489|NCT03547102|Dietary Supplement|Placebo concentrate|
15913490|NCT03547089|Device|Viveve®|A single treatment using Viveve® with 110 pulses administered to the vaginal introitus at 90 J/cm2
15913491|NCT03547076|Diagnostic Test|Focused ultrasound diagnostics|"Patients first be examined by nurses using a pocket-sized imaging device. Secondly, by a General Practitioner using the pocket-sized imaging device. Thirdly, reference echocardiography will be performed by cardiologist using a high-end echocardiographic scanner. Only tools (ultrasound equipment and dedicated software) approved for clinical practice will be used.
~The focused ultrasound examination includes three standard apical views (4-chamber, 2-chamber and long axis) with and without color Doppler, in addition to recordings from both pleural cavities and the inferior vena cava. The reference imaging includes the same recordings, but in addition all other chambers and valves are assessed (grey scale, color Doppler, pulsed wave and continuous wave Doppler and tissue Doppler)."
15913492|NCT03547050|Other|Blood draw|Participation includes one visit for one blood draw per recruited patient. 10-20ml peripheral venous blood will be taken from the antecubital fossa. The DNA from the blood sample will then be extracted and resequenced for analysis.
15913493|NCT03547050|Other|Existing samples|Control DNA samples will be used that have been previously acquired in other studies.
15913494|NCT03547037|Drug|JNJ-63723283|JNJ-63723283 will be administered intravenously.
15913495|NCT03547037|Drug|Erdafitinib|Erdafitinib will be administered orally.
15913496|NCT03547024|Drug|JNJ-55308942 High Dose|Participants will receive high dose of JNJ-55308942 orally once daily.
15913497|NCT03547024|Drug|JNJ-55308942 Low Dose|Participants will receive low dose of JNJ-55308942 orally once daily.
15913498|NCT03547024|Drug|Levonorgestrel/Ethinyl Estradiol Fixed Dose combination (FDC)|Participants will receive 0.150 milligram (mg) levonorgestrel and 0.030 mg ethinyl estradiol FDC tablet orally.
15913499|NCT03547024|Drug|Drug Cocktail:Midazolam (2mg)/Omeprazole (20mg)/Dextromethorphan (30mg)|Participants will receive single dose of drug cocktail consisting of midazolam (2 mg), dextromethorphan (30mg) and omeprazole (20 mg) orally.
15913500|NCT03547011|Procedure|US guided Quadratus Lumborum block|Patients will receive ultrasound guided quadratus lumborum block with 0.3 ml /kg bupivacaine 0.25% on each side with catheter insertion for maintenance doses 0.1ml/kg/hr on each side.
15913501|NCT03547011|Procedure|US guided Paravertebral block.|Patients will receive ultrasound guided thoracic paravertebral block with 0.3 ml/kg bupivacaine 0.25 % on each side with catheter insertion for maintenance doses 0.1 ml/kg/hr on each side.
15913502|NCT03546998|Diagnostic Test|Clinical instrumental examinations|Achalasia patients were periodically submitted to clinical assessment, barium swallow (esophageal diameter and residual barium column were measured), endoscopy. Mucosal esophageal biopsies were taken in order to diagnose dysplasia or epidermoid carcinoma.
15913503|NCT03546985|Device|episil®|Firmly press the pump and apply the stream of liquid to the oral cavity 3 times (a total volume of 0.45 mL approximately). Distribute to affected areas in the mouth, for example by using the tongue. Wait for 5 minutes for the protective film to form.
15945282|NCT03300609|Drug|Oxaliplatin|Given IV
15913504|NCT03546985|Device|Kang Su|Gently pour 5 mL of rinse into the mouth, keep the rinse staying in the oral cavity for at least 1 minute, and spilt out the liquid.
15913505|NCT03546972|Other|Behavioral, Psychological or Informational Intervention|Take part in DDP
15913506|NCT03546972|Other|Behavioral, Psychological or Informational Intervention|Take part in HT
15913507|NCT03546972|Other|Questionnaire Administration|Ancillary studies
15913508|NCT03546959|Other|Lycra sleeve|custom-fitted lycra sleeve extending from axilla to wrist
15913509|NCT03546959|Other|Rehabilitation|Passive, active and active assistive range of motion and stretching exercises for shoulder, elbow, wrist, facilitation and inhibition techniques, neuromuscular electrical stimulation for wrist extensors, strengthening exercises for affected upper extremity, occupational therapy
15913510|NCT03546959|Drug|Botulinum Toxin|Botulinum toxin injection for upper limb spasticity after stroke
15913511|NCT03546946|Behavioral|Gaze-Contingent Music Reward Training|Participants will hear their selected music track playing, dependent on their gaze location, when viewing a grid on neutral and negative faces.
15913512|NCT03546946|Behavioral|Control Training|Participants will hear their selected music track playing, regardless of their gaze location, when viewing a grid on neutral and negative faces.
15913513|NCT03546933|Device|VitalScan Magnetocardiograph|A passive, non-contact, mobile medical device that measures, displays, stores, and retrieves magnetic fluctuations caused by heart activity at a patient's bedside.
15913514|NCT03546920|Behavioral|ALIGN Intervention Phase|"Communication: The PCSW will follow this structured process to improve and facilitate communication for intervention patients. 1. Attend routine weekly facility-led rounds/meetings reviewing patients, their needs and attend discharge planning conference; 2. Visit with patient and caregiver after the discharge planning conference to ensure understanding of the plan of care; 3. Ensure all appropriate community programs (home health, community palliative care) have made contact and established care, assess the transition, and revisit domains from the initial assessment; 4. Suggest questions that need to be asked of community providers. Throughout the intervention, the PCSW will communicate updates from the visits to all involved providers.
~Visits will also focus on increasing goal alignment with the objective that all participants have a ROLT score that is most aligned. Visits will also explore goals of care; this includes completion or review of advance directives."
15913515|NCT03546907|Drug|Itepekimab (SAR440340)|Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
15913516|NCT03546907|Drug|Placebo|Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
15913517|NCT03546907|Drug|Any Inhaled Corticosteroids as prescribed by treating physician as standard of care|Pharmaceutical form:Aerosol or Dry Powder inhaler Route of administration: Inhaled
15913518|NCT03546907|Drug|Any Long Acting Beta Agonist as prescribed by treating physician as standard of care|Pharmaceutical form:Aerosol or Dry Powder inhaler Route of administration: Inhaled
15913519|NCT03546907|Drug|Any Long Acting Muscarinic Agonist as prescribed by treating physician as standard of care|Pharmaceutical form:Aerosol or Dry Powder inhaler Route of administration: Inhaled
15913520|NCT03546907|Drug|Any short-acting β agonist as prescribed by treating physician as standard of care|Pharmaceutical form: Aerosol or Dry Powder inhaler Route of administration: inhaled
15913521|NCT03546894|Drug|Brigatinib|Brigatinib tablets.
15913522|NCT03546894|Drug|Alectinib|Alectinib capsules.
15913523|NCT03546894|Drug|Ceritinib|Ceritinib capsules.
15913524|NCT03546894|Drug|Lorlatinib|Lorlatinib capsules.
15913525|NCT03546894|Drug|Any FDA Approved ALK Inhibitors|FDA approved ALK inhibitors available for treatment.
15913526|NCT03546881|Procedure|fusion imaging guidance technology|Imaging fusion guidance overlay used during PAOD endovascular revascularisation
15913527|NCT03546881|Procedure|2D X-ray screen|2D X-ray screen during PAOD endovascular revascularisation
15913528|NCT03546868|Drug|[18F]FSPG|Patients will receive 200 MBq of [18F]FSPG and undergo PET/CT for assessing disease activity in inflammatory bowel disease
15913529|NCT03546855|Drug|Apatinib|Apatinib 500mg/d po,28 days as one cycle
15913530|NCT03546842|Biological|9vHPV vaccine|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine in a 0.5-mL intramuscular injection
15913531|NCT03546829|Drug|Vancomycin|125 mg, 4x daily for 5 weeks
15913532|NCT03546829|Radiation|Stereotactic Body Radiation Therapy (SBRT)|Patients planned to undergo SBRT to a lung lesion will be randomized to either vancomycin for 1 week before RT and for 1 month after start of RT,
15913533|NCT03546816|Drug|5mg Serlopitant Tablets|Serlopitant Tablets
15913534|NCT03546816|Drug|Placebo Tablets|Placebo Tablets
15913535|NCT03546803|Other|3M™ Cavilon™ Advanced Skin Protectant|liquid skin protectant on skin to protect from radiation dermatitis
15913536|NCT03546790|Drug|Marijuana|Marijuana smoked via blunts with different cigar wrappers
15913537|NCT03546777|Device|magnetic resonance imaging|magnetic resonance imaging of shoulder
15913538|NCT03546764|Device|Percutaneous catheter|tube inserted to drain hemothorax
15913539|NCT03546751|Device|Continuous Positive Airway Pressure|This device delivers air pressure non invasively through a mask to stent open the upper airway to prevent obstruction during sleep. This is an FDA approved device that has been used for several decades to treat OSA.
15913540|NCT03546751|Other|Diet And Exercise|This will consist of weekly telephone and monthly face to face visits to monitor and suggest measures to improve diet and regular exercise as conducted by a registered dietician.
15913541|NCT03546738|Procedure|Burst Spinal Cord Stimulation|Burst stimulation utilizes complex programming to deliver high-frequency stimuli of a 40 Hz burst mode with 5 spikes at 500 Hz per spike delivered in a constant current mode
15913542|NCT03546738|Procedure|Sham spinal cord stimulation|No spinal cord stimulation is provided
15913543|NCT03546738|Device|SCS implant|"a subcutaneously implantable pulse generator (pacemaker) for long-term therapy"
15913544|NCT03546725|Device|Compression stocking|Compression stocking with length below the knee and a class two compression level (corresponding to 23-32 mmHg compression).
15913545|NCT03546712|Other|Tactile Localization|tactile localization is help to assess touch sensation
15913613|NCT03546088|Drug|Topical anaesthesia|Topical anaesthesia with lidocaine will be provided through nebulisation and instillation. The intubating tube will be lubricated with a gel containing lidocaine.
15913546|NCT03546699|Diagnostic Test|Estimation of hospital-wide incidence of ARDS|"Estimation of hospital-wide incidence of ARDS defined according to both the Berlin definition and the Kigali modification.
~To describe clinical characteristics and outcomes for these patients.
~To analyze the prognosis and time course of patients who initially meet criteria for Kigali-defined ARDS and subsequently progress to Berlin-defined ARDS.
~For the subset of patients who have chest CT, to determine the sensitivity and specificity for bilateral opacities of both chest radiographs and chest ultrasound done within 12 hours as compared to the reference standard CT scans."
15913547|NCT03546686|Drug|Ipilimumab|Patients will receive ipilimumab 1-5 days prior to core biopsy and cryoablation.
15913548|NCT03546686|Drug|Nivolumab|Patients will receive nivolumab 1-5 days prior to core biopsy and cryoablation and every 2 weeks post surgery for 3 additional doses
15913549|NCT03546686|Procedure|Core Biopsy/Cryoablation|US-guided core biopsy and cryoablation 7-10 days prior to surgery.
15913550|NCT03546686|Procedure|Breast Surgery|Standard-of-care definitive surgery.
15913551|NCT03546673|Behavioral|Self-Regulation Condition|
15913552|NCT03546673|Behavioral|Emotional Disclosure Condition|
15913553|NCT03546660|Device|SECM capsule|Subjects will swallow a SECM capsule and the SECM imaging will be performed
15913554|NCT03546647|Device|Dailies Aqua Comfort Plus Toric|Daily disposable soft toric contact lens
15913555|NCT03546647|Device|Dailies Aqua Comfort Plus Sphere|Daily disposable soft spherical contact lens
15913556|NCT03546634|Biological|Sabin IPV|We select one Sabin IPV product, produced by China National Biotec Group, which is available for China's National Immunization Program in the selected study sites.
15913557|NCT03546621|Drug|Myrcludex B|2 mg, once daily, subcutaneously
15913558|NCT03546621|Drug|Myrcludex-B|5 mg, once daily, subcutaneously
15913559|NCT03546621|Drug|Myrcludex-B|10 mg, once daily, subcutaneously
15913560|NCT03546621|Drug|Tenofovir|tenofovir disoproxil 245 mg, equivalent to tenofovir disoproxil fumarate 300 mg
15913561|NCT03546608|Drug|Tepotinib|Participants will receive a single oral dose of tepotinib in Part 1.
15913562|NCT03546595|Other|Auricular acupoints acupressure|The magnetic beads were taped to the auricular acupressure points, by the same acupuncture specialist on one ear approximately after skin sterilization, and the subjects were asked to massage the points for 5 minutes, 30 minutes before three meals and sleep.The magnetic beads were left in situ, but replaced with new ones once every week in the other ear.
15913563|NCT03546595|Other|Sham auricular acupoints acupressure|The magnetic beads were taped to the auricular acupressure points, by the same acupuncture specialist on one ear approximately after skin sterilization, and the subjects were not asked to massage the points.The magnetic beads were left in situ, but replaced with new ones once every week in the other ear.
15913564|NCT03546582|Drug|Pembrolizumab|Anti-PD-1 targeted immunotherapy
15913565|NCT03546582|Radiation|Stereotactic Body Radiation Therapy (SBRT)|High-precision radiotherapy
15913566|NCT03546556|Drug|Fluorothymidine (FLT)|A total of 12 patients who have undergone allogenic bone marrow transplantation will undergo FLT-PET-MRI imaging on two separate occasions. In addition to the 12 allogenic transplant patients, 3 patients undergoing autologous stem cell transplant will also be imaged the same two time points in order to determine how much of the FLT signal observed after allogeneic transplant is unique to that population and the result of allo-antigen driven T cell expansion.
15913567|NCT03546543|Procedure|Position change|Each subject will serve as his or her own control. Half of the infants will be placed supine for 3 hours, followed by 3 hours of prone positioning and back to supine for 3 hours and the other half will be start in prone position with consecutive periods of supine and then prone
15913568|NCT03546530|Drug|Interferon|Interferon
15913569|NCT03546530|Drug|Interferon+resveratrol|Interferon+resveratrol
15913570|NCT03546517|Other|Dry Needling|Dry needling of biceps brachii, brachialis, flexor digitorum superficialis and flexor digitorum profundus, triceps brachialis, extensor digitorum and adductor pollicis
15913571|NCT03546517|Other|Sham Dry Needling|Sham Dry needling of biceps brachii, brachialis, flexor digitorum superficialis and flexor digitorum profundus, triceps brachialis, extensor digitorum and adductor pollicis
15913572|NCT03546504|Behavioral|Procedure alteration and occupational therapy|Modification of the dental environment and procedures to decrease sensory stimulation. Occupational therapy (8 weeks; 2x/week): sensory desensitization, habit training, social stories around dental visits
15913573|NCT03546491|Drug|Preventive Gel|0.4% Stannous Fluoride
15913574|NCT03546491|Drug|Marketed Control|0.243% Sodium Fluoride
15913575|NCT03546478|Biological|99mTc-ABH2|99mTc-ABH2 were injected into the patients before the SPECT/CT scans
15913576|NCT03546465|Drug|ropeginterferon alfa-2b|6 subjects in each cohort will receive a single dose by subcutaneous injection
15913577|NCT03546452|Diagnostic Test|in vitro NGS-panel|cell free DNA ,which was purified from hydrothorax, is used to be tested by NGS-panel
15913578|NCT03546426|Drug|Pembrolizumab|200 mg IV q3w until disease progression, unacceptable toxicity or informed consent withdrawal, or for a maximum of 2 years
15913579|NCT03546426|Biological|Autologous dendritic cells|Autologous dendritic cells (DC) loaded with autologous tumor homogenate, 10 x7 cells ID every 3 weeks for up to six doses
15913580|NCT03546426|Drug|Interleukin-2|3 MU s.c. from day +2 to day +6 after each DC administration
15913581|NCT03546400|Drug|methylphenidate HCl ERCT|methylphenidate HCl ERCT
15913582|NCT03546387|Other|Wechsler Intelligence Scale for Children, Fifth Edition (WISC-V)|the WISC-V assessment produces a Full Scale IQ (FSIQ) used for primary power consideration in this study. The FSIQ is the most comprehensive global ability score on the WISC-V, and it has been conventionally reported and interpreted as an estimation of overall intellectual ability
15913583|NCT03546387|Other|California Verbal Learning Test, Children's Version|Used to assess verbal learning and memory in children and adolescents
15913584|NCT03546387|Other|Beery Developmental Test of Visual Motor Integration, 6th edition|Helps assess visual-motor skills in children and adults.
15913585|NCT03546387|Other|Grooved Pegboard Test|Measures dexterity
15913614|NCT03546088|Drug|Light sedation|The patient will be sedated with a combination of midazolam, fentanyl administered intravenously in small boluses until the desired level of sedation is achieved as expressed of The Observer's Assessment of Alertness/Sedation Scale (OAA/S) of 4 or 5.
15913615|NCT03546075|Dietary Supplement|Resveratrol|
15913586|NCT03546387|Other|Behavior Assessment System for Children/Parent Report|The Behavior Assessment System for Children/Parent Report is a questionnaire that assesses the social-emotional and behavioral functioning (e.g., anxiety, depression, attention, hyperactivity, adaptability, leadership, social skills, etc.) in children between the ages of 2 and 22 years, and is available in English and Spanish.
15913587|NCT03546374|Procedure|Surgical Ablation|In addition to the concomitant surgery, subjects are required to have amputation or closure (with sutures or ligation) of the left atrial appendage.The Cox Maze IV lesion set is required to be performed.
15913588|NCT03546374|Device|Cardioblate and Cryoflex hand held devices|The Cardioblate hand held devices consist of the Cardioblate iRF and Cryo surgical ablation devices.
15913589|NCT03546361|Biological|Autologous Dendritic Cell-Adenovirus CCL21 Vaccine|Given via CT-guided or bronchoscopic IT injection
15913590|NCT03546361|Biological|Pembrolizumab|Given IV
15913591|NCT03546348|Other|no intervention|only measurement of the carrying angle
15913592|NCT03546335|Drug|89Zr-DFO-CZP|89Zr-DFO-Certolizumab pegol (89Zr-DFO-CZP) is a radiopharmaceutical imaging agent that will be produced under Current Good Manufacturing Practice (CGMP) regulations in the Department of Radiology and Biomedical Imaging Radiopharmaceutical Facility at University of California, San Francisco (UCSF).
15913593|NCT03546322|Other|Registry|Patients who are diagnosed with head and neck cancer and monitored by the Otolaryngology - Head and Neck Surgery clinic at Zuckerberg San Francisco General Hospital and Trauma Center will be included in this group. The intervention is the implementation of a registry, designed to replace existing paper-based systems for tracking patients. All head and neck cancer patients monitored by the clinic will be included.
15913594|NCT03546309|Device|RIC group|Patients allocated to the RIC group will undergo RIC procedure during which bilateral arm cuffs are inflated to a pressure of 50 mmHg over systolic blood pressure for five cycles of 5 min followed by 5 min of relaxation of the cuffs.
15913595|NCT03546309|Device|sham group|patients allocated to the sham group will undergo a sham RIC procedure during which bilateral arm cuffs are inflated to a pressure of 30 mmHg for five cycles of 5 min, followed by 5 min of relaxation of the cuffs.
15913596|NCT03546283|Drug|Placebos|The patients with hypertensive intracerebral hemorrhage will be randomized into giving placebos, the other treatments in this group follow the guidelines on the treatment of hypertensive intracerebral hemorrhage.
15913597|NCT03546283|Drug|Cattle Encephalon Glycoside and Ignotin|The patients with hypertensive intracerebral hemorrhage will be randomized into giving CEGI, the other treatments in this group follow the guidelines on the treatment of hypertensive intracerebral hemorrhage.
15913598|NCT03546270|Behavioral|Swimming|This group completed 20-weeks of swimming
15913599|NCT03546257|Device|magnifying endoscopy with narrow band imaging (ME-NBI)|A system consisting of a magnifying endoscope combined with narrow-band imaging (NBI), with the spectral band width narrowed by optical filters, was developed to enhance visualization of mucosal surface structure and vascular architecture. There were some reports that the magnifying endoscopy with narrow band imaging (ME-NBI) is superior to predict the histologic differentiation, depth of invasion and lesion margin than WLE.
15913600|NCT03546244|Behavioral|musical treadmill|Patients will undergo a 4-week, 2 daily, incremental session of training with musical treadmill
15913601|NCT03546244|Behavioral|Traditional treadmill|Patients will undergo a 4-week, 2 daily, incremental session of training with traditional treadmill
15913602|NCT03546218|Device|Smartphone Application (SPSRS)|"Participants use application on iPhone and watch videos showing positive-word stimuli. This application repeats positive-word stimuli every 5 seconds.
~The participants watch 3-minute motion picture displaying positive-word stimuli."
15913603|NCT03546218|Device|Smartphone Application (YouTube)|Participants will watch the same motion picture as the experimental group. However, a positive-word stimulus does not appear in the motion picture.
15913604|NCT03546205|Drug|JNJ-64565111|All participants will receive a single SC dose of JNJ-64565111 solution on Day 1.
15913605|NCT03546192|Biological|Fluzone Quadrivalent Influenza Vaccine|0.5-mL, Intramuscular, SH 2015 formulation
15913606|NCT03546179|Other|tidal volume challenge test|Tidal volume (VT) will be increased from 6 to 8 ml/kg of for one minute and hemodynamic variables, including PVI with 8 ml/kg tidal volume ventilation (PVI8) will be recorded.
15913607|NCT03546179|Other|Volume loading|After these two baseline hemodynamic measurements, volume expansion will be performed for 10 min using an infusion of balanced crystalloid solution (6ml/kg of predicted body weight).
15913608|NCT03546166|Drug|Picato 0.05% Topical Gel|apply on and 1 cm around the lesion, 0.47 g of Picato® gel 150 µg/g, once a day on 2 consecutive days. In case of treatment failure after 3 months, apply again on and 1 cm around the lesion, 0.47 g of Picato® gel 150 µg/g, once a day on 2 consecutive days.
15913609|NCT03546153|Behavioral|Aerobic exercise program|Exercise program consists of training for 60 minutes, three times per week for 12 weeks. Participants will use a treadmill, Nu stepper/bike or elliptical to exercise.
15913610|NCT03546127|Genetic|Next Generation Sequencing (NGS): exome, RNA seq|"Tumor and blood samples will be sequenced at medium-high coverage at the whole genome (exome) and transcriptome levels (RNA Seq). This will allow detecting variants in a larger set of samples even though only from the main clone will be precisely measured. The whole exome will be performed at a mean coverage of at least 60x for the normal DNA samples and 120x for the tumor DNA samples. The transcriptome of the tumor will be performed at enough depth of coverage to detect gene fusions, transcriptome variants and measure the digital expression of already annotated isoforms.
~For both sequencing configurations:
~Data from each cancer and normal genome will be analysed for the presence of somatic variants.
~DNA and RNA sequencing results will be integrated.
~Technical replication for the mutations / chromosome alterations / transcript fusions that most likely drive the tumour process will be performed via Target Resequencing of the genomic / coding regions of interest."
15913611|NCT03546114|Other|Gender Questionnaire|13-items questionnaire including demographics questions (gender, age, education; naive to osteopathic treatment or not; general gender preferences; specific gender preference in case of low back pain, neck pain, gastrointestinal disorders, musculoskeletal disorders of upper and lower limbs pain; headache; urogenital disorders
15913612|NCT03546088|Device|fiberoptic naso-tracheal intubation|The trachea will be intubated under direct fiberoptic view after a fiberoptic upper airway examination. The flexible nasolaryngoscope will be armed with an intubating tube and passed inside tracheal lumen trough one of the nostrils.
15913616|NCT03546075|Other|Placebo|
15913617|NCT03546062|Other|patients treated by HTx|From removed and frozen hearts, authors will conduct a tissue and molecular analysis of possible mechanisms T2DM linked.
15913618|NCT03546049|Procedure|US-guided percutaneous biliary drainage|"Device: metal stent. The self-expandable metal stent is implanted percutaneously by a transhepatic access route.
~The metal stent is partially covered or non-covered (in cases in which the gallbladder is not removed).
~Length: 6-10 cm. Diameter: 8-10 mm."
15913619|NCT03546049|Procedure|EUS-guided biliary drainage|"Device: metal stent. The transluminal (transgastric, transduodenal or transenteric) implanted self-expandable metal stent is released via echoendoscope.
~The metal stent is partially covered or non-covered (in cases in which the gallbladder is not removed) or mixed covered (one half covered, one half non-covered). The mixed covered stent is used for the transhepatic access.
~Length: 6-10 cm. Diameter: 8-10 mm."
15913620|NCT03546036|Device|Weighted metal chain blanket|Use of a weighted metal chain blanket of 8 kg
15913621|NCT03546036|Device|Control plastic chain blanket|A blanket with light plastic chains
15913622|NCT03546023|Other|Patient Interview|BPI scores will be asked by the Doctor or the Research Nurse
15913623|NCT03546010|Behavioral|Neuropsychological tests|WISC test, BRIEF test, NEPSY-2 test, TAP2.3 test, Teach test
15913624|NCT03546010|Behavioral|Oculometric tests|When the subject see a peripheric target, he should take a look not at the target but in the controlateral half-field, at a mirror position. This is called an anti-saccade task.
15913625|NCT03545997|Drug|Montelukast 10mg|The capsules will be presented in box of 95 capsules packaged in unit blister
15913626|NCT03545997|Drug|Placebo|Mannitol 350mg The capsules will be presented in box of 95 capsules packaged in unit blister
15913627|NCT03545984|Other|Simulation-based learning|Simulation-based teaching involves using done on a mannequin to simulate actual conditions
15913628|NCT03545984|Other|interactive problem based learning|Standard teaching (problem based learning discussion) during cardiac/vascular rotation
15913629|NCT03545971|Drug|IBI310|IBI310 is anti CTLA-4 antibody
15913630|NCT03545971|Drug|Sintilimab|PD-1 monoclonal antibody
15913631|NCT03545958|Behavioral|High-intensity Interval Training (HIT)|Following the mind-motor training component, participants in the experimental group will then continue in the 45-minute HIT intervention, which will be composed by a 10-minute warm-up, a 25-minute core activity, and a 10-minute cool down. The 25-minute core activity will be carried out based on a 4 x 4 minutes aerobic interval training model. The intensity in each cycle will be prescribed at an individual level, and training heart rates will be determined via a sub-maximal excise testing at baseline and monitored during exercise using a wrist-based heart rate monitor (Suunto). In order to ensure progression in aerobic training over the 6-month intervention, training heart rates will be recalculated at the intervention midpoint (i.e., 3 months), where a new sub-maximal exercise test will be performed. Participants will exercise 60 minutes/day, 3 days/week for 6 months.
15913632|NCT03545958|Behavioral|Moderate-intensity Continuous Training (MCT)|After the mind-motor training component, participants in the comparison/control group will then continue in the 45-min MCT intervention, which will be composed by a 10-minute warm-up a 25-minute moderate-intensity continuous aerobic exercise training, and a 10-minute cool down. The exercise intensity will be prescribed at an individual level, and training heart rates will be determined via a sub-maximal excise testing at baseline and monitored during exercise using a wrist-based heart rate monitor (Suunto). In order to ensure progression in aerobic training over the 6-month intervention, training heart rates will be recalculated at the intervention midpoint (i.e., 3 months), where a new sub-maximal exercise test will be performed. Participants will exercise 60 minutes/day, 3 days/week for 6 months.
15913633|NCT03545945|Procedure|Additional office hysteroscopy|Patients in the study arm will undergo diagnostic office hysteroscopy where they look for any underlying polyp, fibroids or uterine anomaly in addition to endometrial biopsy.
15913634|NCT03545945|Procedure|Endometrial biopsy|Patients randomized to endometrial biopsy only group will be prepped with betadine solution and local anesthesia in the form of lidocaine gel placed in the external cervical canal and biopsy will be performed using a Pipelle catheter.
15913635|NCT03545932|Other|exercise program hydrogymnastics|4 months of practice hydrogymnastics
15913636|NCT03545906|Other|TEAM-UP Intervention Group|Children randomly assigned to TEAM-UP will have a telemedicine assisted specialist visit scheduled after 4 weeks of initiating DOT at school, as well as 2 subsequent follow-up visits. The visits will be performed by a specialist in pediatric asthma, to implement guideline-based care. Prescriptions for asthma medications will be prescribed to be delivered as directly observed therapy in school.
15913637|NCT03545906|Other|Enhanced Care Comparison|Similar to the TEAM-UP group, children in the Enhanced Care group will receive a symptom assessment and asthma education materials at baseline, and we will contact the PCP by facsimile or email and will recommend DOT of preventive asthma medication through school as well as a referral to specialist. However specialist visits will not be facilitated via telemedicine.
15913638|NCT03545893|Drug|Ibuprofen 600 mg|Ibuprofen 600mg prescription, to be taken 1 tablet as needed every 6 hours for pain.
15913639|NCT03545893|Drug|OxyCODONE 5 Mg Oral Tablet|Oxycodone 5mg Oral Tablet prescription, to be taken 1-2 tablets as needed every 6 hours for pain.
15913640|NCT03545880|Other|Kinesiotaping|A Kinesiotaping will be provided over the upper trapezius muscle after the application of dry needling
15913641|NCT03545880|Other|Placebo|Individuals will not perform any action after the application of trigger point dry needling
15913642|NCT03545867|Behavioral|Seated control (CON)|Seated rest
15913643|NCT03545867|Behavioral|Moderate intensity continuous (MICT)|Arm cycling at a continuous power output
15913644|NCT03545867|Behavioral|High intensity interval training (HIIT)|Arm cycling at power outputs that vary between high and low intensity intervals
15913645|NCT03545867|Behavioral|Circuit resistance training (CRT)|Alternating between six upper extremity resistance maneuvers interspersed with low-resistance/high-speed arm cycling.
15913646|NCT03545867|Other|Liquid Meal|A liquid meal consisting of 600 kcal comprised of 50% carbohydrate, 35% fat, and 15% protein (by kcal).
15913647|NCT03545854|Procedure|Erector Spinae Plane Block|Ultrasound guided injection of coloring solution (methylene blue diluted in water) with a 18G echogenic tuohy needle deep to the plane of the erector spinae muscles.
15913648|NCT03545841|Other|HIT|Participants completed 6 weeks of HIT
15913649|NCT03545841|Other|MICT|Participants completed 6 weeks of MICT
15913652|NCT03545802|Behavioral|Home-HIT|Participants completed 6 weeks of home-based high-intensity interval training 3 times per week
15913653|NCT03545789|Drug|[18F]MNI-958|Subjects will undergo PET imaging using [18F]MNI-958, a PET radioligand for imaging tau.
15913654|NCT03545776|Other|Critical Care EEG Course|"Medical and nursing staff will be given a 10-points EEG face-to-face initial training course followed by an online teaching and educational quizzes at day-1, day-15 and day-30 after initial training. A final evaluation will be performed at day-90 after beginning of the training course.
~10-points EEG educational objectives : physiological rhythms, reactivity, symmetry, effects of sedation, burst suppression, paroxysmal activities, periodic / pseudoperiodic activities, rhythmic activities, artifacts, null EEG"
15913655|NCT03545763|Other|Medicaid Expansion|There will be no direct intervention, but rather an observation of change based on whether a state expanded Medicaid or not
15913656|NCT03545737|Other|Measurement|The distances between the midpoint of the thyroid cartilage to suprasternal notch base on body surface measurement add the distance between suprasternal notch to carina of trachea according to chest CT
15913657|NCT03545737|Other|Formula|The formula base on patient's height as a guide for the intubation of a Left-sided Double-lumen tube
15913658|NCT03545724|Device|Neofitoroid®|NeoFitoroid® forms a protective barrier mucosa and on perianal region that can aid the physiological process of healing.
15913659|NCT03545711|Drug|Anlotinib Hydrochloride with Irinotecan|Dose escalation of anlotinib starts from 8mg qd d1-14/q21d in combination with fixed dose of irinotecan at 180mg/m2 d1/q14d.
15913660|NCT03545698|Other|Avizia Telehealth Platform|Avizia will be utilized as a communication tool between home-based caregivers (family members, formal caregivers, or informal caregivers) and the House Calls care management team.
15913661|NCT03545685|Other|specific memory and attention realtime training|The investigator will conduct a pilot study of 80 APS subjects (age 18-45). The investigator will examine SMART feasibility and user engagement using a randomized control trial research design. Using a simple random method, 40 APS subjects will be randomly assigned to the experimental group to receive add-on SMART intervention for 3 months and 40 APS subjects will just get naturalistic treatment with no SMART intervention. At baseline and 3-month follow-up, subjects will complete questionnaires on app use habits and attitudes towards SMART feasibility and engagement. In-depth interviews will be conducted at both time points to cross-validate the findings obtained from the questionnaires.
15913662|NCT03545672|Diagnostic Test|CMR examination|After recruiting participants and collecting the baseline information, a CMR scan and a post-processed imaging procedure will be carried on in order to detect the cardiac impairment.
15913663|NCT03545659|Other|Mode of relapse/SMN detection|Mode of relapse/SMN detection: whether the relapse/SMN was diagnosed because of symptoms of leukaemia or diagnosed at a routine visit in the outpatient clinic.
15913664|NCT03545646|Device|Treatment with High Intensity Focused ElectroMagnetic system|The treatment administration phase will consist of four (4) treatments, delivered twice a week. The applicator will be applied over the abdomen area. Visible contractions will be induced by the device.
15913665|NCT03545633|Device|Treatment with High Intensity Focused ElectroMagnetic system.|"The treatment administration phase will consist of four (4) treatments, delivered twice a week. The applicator will be applied over the abdomen area.
~Visible contractions will be induced by the device."
15913666|NCT03545620|Device|rescue technique|which rescue technique will be preferred while established/predicted difficult airway/intubation occurs in the operation room after failed direct laryngoscopy
15913667|NCT03545607|Biological|MultiStem|single intravenous infusion 18-36 hours after stroke
15913668|NCT03545607|Biological|Placebo|single intravenous infusion 18-36 hours after stroke
15913669|NCT03545594|Other|Patient-centered in home rehabilitation|Eight contacts (six in-home visits of 1-2 hours duration each and two telephone contacts before the Corona pandemic and eight sessions with up to six of them video delivered if necessary during the Corona pandemic ) delivered over a 4-month period in three phases
15913670|NCT03545594|Other|Control|Usual follow-up in the municipality
15913671|NCT03545581|Other|Experimental diet Fru rich diet|7 days (day 1 to day 7) with fructose enriched drinks 3x/d. Test meal at day 7 with fructose (0.7 g/body weight) and glucose (0.7 g/body weight)
15913672|NCT03545581|Other|Experimental low Fru diet|7 days (day 1 to day 7) with low-fructose diet (<10g/d). Test meal at day 7 with fructose (0.7 g/body weight) and glucose (0.7 g/body weight)
15913673|NCT03545568|Other|Neu5Ac supplementation|Sialic acid as N-Acetyl-neuraminic acid dehydrate (Neu5Ac) 150 mg/kg/d (max 12g/d) in three doses orally in subjects with NANS deficiency compared to controls
15913674|NCT03545555|Dietary Supplement|"Kale Preparation Kale Powder"|Effect of kale preparation kale powder on lipid status
15913675|NCT03545555|Dietary Supplement|"Kale Preparation Kale Extract"|Effect of kale preparation kale extract on lipid status
15913676|NCT03545555|Dietary Supplement|"Kale Preparation Flavonoid Extract"|Effect of kale preparation flavonoid extract on lipid status
15913677|NCT03545555|Dietary Supplement|Placebo|Effect of placebo on lipid status
15913678|NCT03545542|Diagnostic Test|Initial fecal microbiome|Stool sampling for fecal microbiome analysis by 16S rDNA pyrosequencing. Neuroblastoma group and Control group.
15913679|NCT03545542|Diagnostic Test|Initial fecal volatile organic compounds|Volatile organic compound analysis of stool samples by gas chromatography/mass spectroscopy Neuroblastoma group and Control group.
15913680|NCT03545542|Diagnostic Test|Initial breath volatile organic compounds|Breath sampling for organic compound analysis by gas chromatography/mass spectroscopy Neuroblastoma group and Control group.
15913681|NCT03545542|Diagnostic Test|Microbiome under chemotherapy|Stool sampling under chemotherapy of children in neuroblastoma group (1 sample 1 week after completion of each chemotherapy cycle). Chemotherapy according to Société Internationale d´Onclogie Pediatrique Neuroblastoma Group (SIOPEN) guidelines
15913682|NCT03545542|Diagnostic Test|Fecal volatile organic compounds under chemotherapy|"Stool sampling under chemotherapy of children in neuroblastoma group (1 sample 1 week after completion of each chemotherapy cycle). Chemotherapy according to SIOPEN guidelines.
~Neuroblastoma group"
15913683|NCT03545542|Diagnostic Test|Breath volatile organic compounds under chemotherapy|"Breath sampling under chemotherapy of children in neuroblastoma group (1 sample 1 week after completion of each chemotherapy cycle). Chemotherapy according to SIOPEN guidelines.
~Neuroblastoma group"
15913684|NCT03545542|Diagnostic Test|Final microbiome|Stool sampling 3 weeks after completion of chemotherapy Neuroblastoma group
15913685|NCT03545542|Diagnostic Test|Final fecal volatile organic compounds|Stool sampling 3 weeks after completion of chemotherapy Neuroblastoma group
15913686|NCT03545542|Diagnostic Test|Final breath volatile organic compounds|Breath sampling 3 weeks after completion of chemotherapy Neuroblastoma group
15913687|NCT03545529|Other|Innovativ supported|addition of connected tools and stronger accompaniment to prevent falls
15913688|NCT03545516|Drug|Bupivacaine|Injection of bupivacaine into the surgical incision prior to its closure.
15913689|NCT03545516|Drug|Dexmedetomidine|Injection of dexmedetomidine ( an adjuvant) into the surgical incision prior to its closure.
15913690|NCT03545516|Drug|Placebo|Injection of a placebo into the surgical wound
15913691|NCT03545503|Drug|Etomidate|Etomidate will be administered as the sedative for RSI on even days
15913692|NCT03545503|Drug|Ketamine|Ketamine will be administered as the sedative for RSI on odd days
15913693|NCT03545490|Other|Ensure|Ensure(Supplement) +Nutrition education Ensure 3 times per day, Mixing 55.8 g or 6 spoons of Ensure with 190 mL of warm water.
15913694|NCT03545477|Other|Novel locomotion treatment: curved-walking training|"Each training session is comprehensive of a 30-minute walking training on curved trajectory (S trajectory composed by two semicircle with a radius of 1.2 m)"
15913695|NCT03545477|Other|Standard locomotion treatment: straight-walking training|It consists of 30 minutes of locomotion training on straight trajectories, as typically proposed during traditional gait rehabilitation
15913696|NCT03545477|Other|Standard physical therapy|It consists of 60 minutes of stretching, muscular conditioning and coordination,postural exercises for trunk control, standing, functional exercies and upper limb rehabilitation, customized on patient's need.
15913697|NCT03545464|Drug|Placebo Oral Tablet|Placebo of cortancyl Oral Tablet 20mg
15913698|NCT03545464|Drug|Cortancyl Oral Tablet|Cortancyl oral Tablet 20 mg
15913699|NCT03545464|Drug|Levocetirizine Oral Tablet|Levocetirizine Oral Tablet 5 mg
15913700|NCT03545451|Device|Videogames|Videogames
15913701|NCT03545438|Biological|LIB003|LIB003 or placebo
15913702|NCT03545425|Procedure|Biofluid samplings|Blood and Urine
15913703|NCT03545412|Device|Microfocused ultrasound with visualization|Each subject to receive a minimum of 800 treatment lines, on two planes of treatment using the 4-4.5mm and 7-3.0mm transducer depths
15913704|NCT03545399|Dietary Supplement|Ulva Lactuca|The dose was taken with a glass of water during the evening meal once daily
15913705|NCT03545399|Dietary Supplement|Placebo|The dose was taken with a glass of water during the evening meal once daily
15913706|NCT03545386|Other|Fecal microbiota transplantation|Stool from healthy donor administered via enema
15913707|NCT03545386|Other|Placebos|Saline with food coloring administered via enema
15913708|NCT03545373|Drug|Azithromycin|Azithromycin tablet taken orally
15913709|NCT03545373|Drug|Amoxicillin|Amoxicillin tablets taken orally
15913710|NCT03545360|Device|BTL-703 (Treatment group)|Treatment with BTL-703 device
15913711|NCT03545347|Drug|Nandrolone Decanoate|Injections every 3 weeks, last injection at week 12. Women 50 mg, men with total testosterone ≥ 11 nmol/l will receive 100 mg, and men with total testosterone < 11 nmol/l will receive a dose of 200 mg.
15913712|NCT03545347|Dietary Supplement|Protein-rich nutritional supplement|The protein-rich nutritional supplement is a liquid containing 18 g milk-based protein pr bottle. Patients will receive a minimum of 1.35 g/kg bodyweight/day); which means that most patients will receive 2 bottles per day for 12 weeks.
15913713|NCT03545347|Other|Physical therapy|The physical therapy intervention will include progressive strength training initiated daily on weekdays during hospitalization and continued twice per week in the outpatient rehabilitation program in the municipality (treatment as usual but with strength training as an obligatory component) for a total intervention period of 12 weeks from time of inclusion.
15913714|NCT03545347|Drug|Sodium Chloride 9mg/ml Injection|Placebo injection of 1 ml Sodium Chloride
15913715|NCT03545334|Diagnostic Test|Visionsense™ VS3 - Stereoscopic High Definition Visualisation System (VS3-3DHD)|Injection of ICG intradermally around the scar of the primary excision of the tumour and transcutaneous assessment of fluorescence with the VS3-3DHD camera (Visionsense™ VS3 - Stereoscopic High Definition Visualisation System ).
15913716|NCT03545321|Behavioral|MOON+|MOON+ is an intervention to support the pharmacy and pharmacist to improve opioid safety and naloxone provision. Materials include educational trainings, materials for use with pharmacists, information for patients, and materials for standardizing overdose safety at the pharmacy
15913717|NCT03545308|Drug|Rocuronium|Dose: 1 mg/kg
15913718|NCT03545295|Procedure|Quadratus Lumborum Block type 2|Ultrasound guided injection of coloring solution using a 18g Tuohy echogenic needle, posterior to the Quadratus Lumborum muscle
15913719|NCT03545295|Procedure|Quadratus Lumborum Block type 3|Ultrasound guided injection of coloring solution using a 18g Tuohy echogenic needle, anterior to the Quadratus Lumborum muscle
15913720|NCT03545282|Behavioral|Amigas Latinas Motivando el Alma (ALMA)|"In a series of 8 weekly sessions, the program uses a group format to teach and encourage women to use coping strategies to reduce depression and anxiety. Over the course of the eight ALMA sessions, 25 women are (1) engaged in activities to identify coping strategies they are currently using and encouraged to continue to use them; (2) introduced to new coping strategies (e.g. mindfulness techniques, increased social ties and social support); and, (3) provided resources for seeking additional help if needed.
~Due to COVID-19 pandemic, the intervention was changed to online synchronous delivery via Zoom over 6 weekly sessions."
15913721|NCT03545269|Drug|CartiLife®|CartiLife® is beads (1.0 to 1.5 mm in diameter) in suspension, developed from autologous chondrocytes. The beads are implanted the volume of 1 cm3 per the capacity of the syringe to the affected area through injection with fibrin adhesive through minimal arthrotomy.
15913722|NCT03545269|Procedure|Microfracture|The surgery is performed by arthroscopy, after the joint is cleaned of calcified cartilage. Through use of an awl, the surgeon creates tiny fractures in the subchondral bone plate.
15913757|NCT03545009|Dietary Supplement|Beetroot Juice no Nitrate|70ml Concentrated Beetroot Juice with nitrate removed
15913758|NCT03545009|Dietary Supplement|Beetroot Juice|70ml Concentrated Beetroot Juice
15913759|NCT03544996|Combination Product|TD Insulin|Human Insulin USP formulated in a solution capable of transdermal delivery.
15913723|NCT03545256|Procedure|outpatient surgery for T1-N0 or T2-N0 cancers of the oral cavity or oropharynx with lymph node search|"The surgical procedure associated with the sentinel lymph node technique is carried out in two stages:
~- Lymphoscintigraphy at Day-1 : This is the identification of the lymphatic network of the patient by a prior injection of radioactive tracer, nanocolloids labeled with technetium99, around the primary tumor. A planar CT image acquisition is performed to identify the sentinel lymph nodes (Gs(s)) which are then marked on the skin with an indelible marker.
~Surgery on D0:
~The patient is admitted to the hospital at 7:00 am in outpatient unit. He is reviewed by the anesthetist before the intervention and is transferred to the operating room for the intervention under AG.
~The main tumor is operated by mouth."
15913724|NCT03545243|Drug|Pantoprazole 40mg|Peroral Pantoprazole 40mg once daily during 28 days
15913725|NCT03545243|Other|PPI withdrawal|PPI withdrawal for 8 weeks
15913726|NCT03545230|Procedure|":Four Not Techniques"|":Four Not Techniques
~Not enter posteriorly
~Not too much dissection the muscle around the lateral condyle during surgery
~Not perfect anatomical reduction
~Not using bone graft."
15913727|NCT03545217|Behavioral|Lifestyle Intervention|a 6-month intensive lifestyle intervention program led by a multidisciplinary team of diabetes nurses and dieticians, and a follow up at 12 months for these participants. This will be a group-based activity adapted from the Diabetes Prevention Program -Thailand project
15913728|NCT03545204|Other|Kangaroo Mother Care Package|"The KMC package will include creation of KMC Champions from within the community, social mobilization to create awareness and its acceptance with families using powerful IEC tools such as docudrama, flip charts, pictorials in local languages; engagement of community and community leaders, capacity building of health care providers on Kangaroo mother care, essential newborn care ENC, policy dialogues with stake holders in the public and private sectors and delivery of a KMC kit  to the pregnant female by the Implementation team"
15913729|NCT03545204|Other|Routine Standard Care|Routine Standard Care ( essential Newborn care )ENC
15913730|NCT03545191|Drug|ACT-541468|Administered orally as tablets.
15913731|NCT03545191|Other|Placebo|Administered orally as tablets.
15913732|NCT03545178|Behavioral|glucose control (Substudy A)|Comparison of glucose values during days 0 - 3 with days 4 - 28 and 0 - 7 with days 8 - 28 before a medical consultation at the diabetes clinic in patients suffering from diabetes and wearing a continuous glucose monitoring and/or flash glucose monitoring device
15913733|NCT03545178|Diagnostic Test|hypoglycemia prediction (Substudy B)|Use of CGM/FGM data to develop and evaluate a neural network based hypoglycemia prediction model
15913734|NCT03545165|Drug|177Lu-PSMA-617|[1.85 GBq (50 mCi) - 9.25 GBq (250 mCi)]
15913735|NCT03545165|Drug|177Lu-J591|[1.35 GBq/m2 or 36.5 mCi/m2]
15913736|NCT03545165|Drug|68Ga-PSMA-HBED-CC|[185 ±74MBq or 5 ±2 mCi]
15913737|NCT03545152|Behavioral|Exercise|"Prescription exercise: frequency, intensity, type, time, and progression (FITT-PRO).
~150 min/week (the intensity will be moderate). exercise routine: warming up, resistance training and aerobic exercise training(range of motion and flexibility exercises)"
15913738|NCT03545152|Behavioral|Cognitive training|Cognitive training intervention consisted of 12 weekly sessions, lasting 60-90 minutes in groups of 5-8 participants, and 3 monthly boost sessions (to review the strategies and practice solving problems as well). The main strategy was to use cognitive rehabilitation strategies to promote generalization in this process to improve memory and behavior.
15913739|NCT03545152|Behavioral|New life-style|Combination of exercise and cognitive interventions
15913740|NCT03545139|Biological|NeoMTA nusmile|A new formulation of MTA was developed in which bismuth oxide was omitted.
15913741|NCT03545139|Biological|White MTA|Revascularization with Conventional white mineral trioxide aggregate as coronal plug.
15913742|NCT03545126|Other|13C6 Leucine|Recruited participants will be given 13C6-labeled leucine through intravenous infusion (4mg/kg/hr for 16hrs)
15913743|NCT03545113|Procedure|Upper arm arteriovenous graft surgery|Creation of arteriovenous graft vascular access for hemodialysis
15913744|NCT03545113|Procedure|Upper arm arteriovenous fistula surgery|Creation of arteriovenous fistula vascular access for hemodialysis
15913745|NCT03545100|Other|motor control therapy|scapular muscle progressive resistive exercise(PRE)
15913746|NCT03545100|Other|regular physical therapy|transcutaneous electrical nerve stimulation(TENS), shoulder joint ROM, scapular muscle PRE
15913747|NCT03545087|Drug|Lanabecestat|Administered orally
15913748|NCT03545087|Drug|Iohexol|Administered intravenously. Administration is at investigator's discretion in participants with severe renal impairment.
15913749|NCT03545074|Behavioral|Mindful Awareness Practices- English|The 6-week intervention aimed at teaching mindfulness-based strategies to participants (in English)
15913750|NCT03545074|Behavioral|Mindful Awareness Practices- Spanish|The 6-week intervention aimed at teaching mindfulness-based strategies to participants (in Spanish)
15913751|NCT03545074|Behavioral|Health Education - English|The health education condition is a weekly 2-hour, 6 session course aimed at knowledge acquisition in subjects related to health care in general (in English)
15913752|NCT03545074|Behavioral|Health Education - Spanish|The health education condition is a weekly 2-hour, 6 session course aimed at knowledge acquisition in subjects related to health care in general (in Spanish)
15913753|NCT03545048|Other|Internet based exercises|Exercises for knee OA (online- digital health)
15913754|NCT03545035|Drug|idelalisib and rituximab|patients with treatment-naïve chronic lymphocytic leukemia (CLL) with TP53 disruption (i.e. 17p- or TP53 mutations) or relapsed/refractory CLL who were treated with idelalisib and rituximab
15913755|NCT03545022|Procedure|Acupuncture|"The application of acupuncture was performed in four sessions, 30 minutes prior to surgery, 24, 48 and 72 hours following the surgery, before variables measurements. The points were manually stimulated and the needles were inserted up to 4mm. There were 11 points, applied bilaterally, two of them, point VG20 and Yintang, for anxiety control, only at the preoperative time and not bilateral. The points to reduce pain, edema, and trismus were IG4 (Hegu), F3 (Taichong) and E44 (Neiting), TA21 (Ermen), ID19 (Ting-Kong), E6 (Jiagle) and E7 (Towei) , point B60 (Kunlum) and VB34 (Yanglingquan). All patients received the same treatment in all sessions.
~After the needle devices were inserted, the needles were re-stimulated manually once after 10 minutes and removed after more 10 minutes."
15913756|NCT03545009|Dietary Supplement|Sodium Nitrate|70ml sodium nitrate, matched for nitrate concentration in Beetroot Juice arm
15913789|NCT03544697|Procedure|Skin expansion and repair with flaps|
15913760|NCT03544983|Behavioral|Web + Streamlined Telephone Genetic Counseling|Tailored and interactive web-based education designed to incorporate all aspects of standard genetic counseling followed by a streamlined genetic counseling session with a board-certified genetic counselor.
15913761|NCT03544944|Drug|TJP-008-1|Subjects who are randomized into group TJP-008-1 will receive bowel preparation on the same-day.
15913762|NCT03544944|Drug|TJP-008-2|Subjects who are randomized into group TJP-008-2 will receive bowel preparation from evening to next morning.
15913763|NCT03544944|Drug|Coolprep powder|Subjects who are randomized into group Coolprep will receive bowel preparation from evening to next morning.
15913764|NCT03544931|Procedure|Root Instrumentation|Instrumentation of the root surface in order to achieve debridement
15913765|NCT03544931|Device|EMD Application|Application of Enamel Matrix Derivatives on the root surface after debridement in sites with probing depth deeper than 5 mm
15913766|NCT03544905|Drug|CYH33 for tablet|1mg; 5mg; 10mg; 20mg; 30mg; 50mg; 75mg; 100mg; 130mg; 160mg; 200mg; 240mgBID or QD(Decided by SMC accroding to the safty and PK data)
15913767|NCT03544892|Other|Low carbohydrate diet|60-80 g total carbohydrate per day
15913768|NCT03544892|Other|Standard of care diet|> 150 g total carbohydrate per day
15913769|NCT03544879|Behavioral|Yoga Intervention|The 60-minute yoga sessions began with a brief breathing practice led by the instructor. The yoga instructor then led students through yoga poses at a gentle pace using chairs as props as needed. The pace of the class increased slowly over time as students became more familiar and more capable with the poses. Meditation and breathing was followed by chair poses (15-20 minutes), standing poses (10-15 minutes), floor poses (15 minutes), and lastly a supine resting pose (Savasana; 10 minutes). In the Silver Age Yoga method at that time, there were 73 available postures overall including: 35 Chair Postures, 18 Standing Postures, 20 Floor Postures, with a typical class covering 20-25 poses.
15913770|NCT03544879|Behavioral|Healthy Aging Education|The health education comparison intervention consisted of once weekly, 90-minute health information workshops conducted in group format. The 90-minute sessions generally consisted of a 60-minute lecture followed by 30 minutes of questions and discussion. The lecture titles for Weeks 1-10 were as follows: Introduction/ Exploring Communication, The Science of Successful Aging, Acupuncture 101: How it Works & What it is Good for, Quality of Life/Quality of Well Being, Fighting Cancer With Your Fork, Forgiveness via Shakespeare's: A Winter's Tale, Better Eyesight in Minutes a Day, Brain Fitness, The Importance of Organic Foods/ Organic Gardening, How Dementia Can Be Modified. Lectures were provided by a mix of credentialed experts (physicians/psychologists, etc) and other clinicians. Instructors were asked not to talk about yoga or medication in their lectures. Content was not otherwise closely monitored.
15913771|NCT03544853|Device|Prosthetic socket for transtibial amputee|To wear a prosthetic socket for evaluation of comfort and biomechanical metrics such as skin loading conditions.
15913772|NCT03544840|Other|Physical Therapy Home Program|On the first day of the intervention phase (B), the PI will deliver the dynamic standing home program device (Upsee) to the parent and child. The PI will provide training and education to the parent on the device and home program. At the weekly visit to score outcome measures, the PI will check the fit of the devices, ensure compliance, and answer any questions about the home program. Parents will be encouraged to use the device with their child 5 days per week, 30 minutes per day. Parents will keep a daily log sheet to record duration of device use, activities performed, and subjective observations of the child during the intervention (Appendix K). The PI will collect these log sheets each week. The baseline phases (A1 and A2) will last 4 weeks and the intervention phase (B) will last 6 weeks. Part 2 of the study is expected to last 14 weeks.
15913773|NCT03544827|Drug|Atropine|Atropine 0.01% then atropine 0.1%
15913774|NCT03544827|Drug|Atropine|Atropine 0.1% then atropine 0.01%
15913775|NCT03544814|Drug|icotinib combined with pemetrexed plus cisplatin|Continued using the icotinib (125 mg/time, 3 times/day every day) combined with Pemetrexed (500 mg/㎡ on day 1) plus cisplatin (75mg/m2 on day 1) and repeat every four weeks for up to six cycles and then continue to receive pemetrexed combined with icotinib every four weeks.
15913776|NCT03544814|Drug|first icotinib and then pemetrexed plus cisplatin|Continued using the icotinib (125 mg/time, 3 times/day every day)) alone until the investigator judged that continuation was adiaphorous, and switched to Pemetrexed (500 mg/㎡ on day 1) plus cisplatin (75mg/m2 on day 1) alone, repeat every four weeks for up to six cycles and then continue to receive pemetrexed every four weeks.
15913777|NCT03544788|Device|Cirvo™ Therapy|The Cirvo(TM) (also referred to as the Radial Medical Compression System) is a mobile wearable medical device that applies graded intermittent mechanical sequential compression for the treatment of venous leg ulcers (VLU).
15913778|NCT03544775|Procedure|Isolated General Anesthesia|No nerve block identified through physician billing codes
15913779|NCT03544775|Procedure|Peripheral Nerve Block|Nerve block identified through physician billing codes
15913780|NCT03544762|Drug|18F-FES PET|18F-FES PET will be performed for each patient. All patients will receive intravenously injection of 5-8 mCi (185-296 MBq) of 18F-FES. PET imaging will be performed on PET/CT system. The 1-frame dynamic data acquisition of thoracic region including the primary tumor will be started immediately after tracer injection. Whole-body PET acquisition from skull base to upper thigh will be started 60 minutes after tracre injection.
15913781|NCT03544749|Device|Ambu® AuraGain™|After induction of anesthesia, Ambu® AuraGain™ will be inserted for the mechanical ventilation.
15913782|NCT03544749|Device|I-gel|After induction of anesthesia, I-gel will be inserted for the mechanical ventilation.
15913783|NCT03544736|Drug|Nivolumab|Experimental: Nivolumab
15913784|NCT03544736|Radiation|Radiotherapy|Radiotherapy
15913785|NCT03544736|Drug|Chemotherapy|Chemotherapy
15913786|NCT03544736|Procedure|Surgery|Surgery
15913787|NCT03544723|Drug|Ad-p53|Antineoplastic, Monoclonal Antibody; PD-1/PD-L1 Inhibitors. Immunotherapy. Gene Therapy.
15913788|NCT03544710|Other|preoperative bathing with antiseptic|"Preoperative bathing with antiseptic was done as follows; Given warm water and a tablet soap containing chloroxylenol antiseptic.
~Asked to bathe under supervision for standardization. Given a clean theatre gown to put on. Taken through the routine pre-operative preparation procedures which involved; Putting an intravenous cannula; administering prophylactic antibiotics. Administering intravenous normal saline 1 liter. taking off a blood sample (3mls) for blood grouping and cross matching. Putting urethral catheter for drainage of urine, Getting an informed consent from the client for the procedure to be done. Informing the theatre team."
15913790|NCT03544684|Behavioral|Effects of the type of exercise on blood glucose concentrations|glucose concentrations were assessed over the 24 hour periods following no exercise, a single bout of high intensity interval training and a single bout of moderate intensity continuous training
15913791|NCT03544671|Dietary Supplement|Vitamin D|
15913792|NCT03544658|Procedure|Dental prophylaxis|Professional dental prophylaxis including dental scaling and dental polishing with prophylactic paste
15913793|NCT03544658|Procedure|Tooth color assessment by the participant|Tooth color assessment using the VITA Classical shade guide. Assessment will be done with normal light conditions and with a light correcting device
15913794|NCT03544658|Procedure|Tooth color assessment by the investigator|Tooth color assessment using the VITA Classical shade guide and the VITA Toothguide 3D Master. Assessment will be done with normal light conditions and with a light correcting device
15913795|NCT03544658|Procedure|Tooth color assessment with SpectroShade|Tooth color assessment using SpectroShade (dental spectrophotometer). Color will be registered in VITA Classical and VITA Toothguide 3D Master and CIELab parameters
15913796|NCT03544645|Other|"Audiovisual material video"|an educational video which has content of knowledge, attitude, behavior, and barriers towards insulin therapy.
15913797|NCT03544645|Other|"Printed material brochure"|an educational brochure which has content of knowledge, attitude, behavior, and barriers towards insulin theray.
15913798|NCT03544632|Drug|Acellular Adipose Tissue (AAT)|"Participants (n=15) will be administered between 5cc and 20cc of AAT, depending on their assigned treatment group, via sterile subcutaneous injection into the target defect. The injection is intended to be permanent. After the 3-month study follow-up visit, participants will have the option to undergo additional AAT injection (up to 20cc per treatment) in order to fully correct the defect. Total injected AAT volume per patient will not exceed 40cc. Additional injection is dependent upon study- and patient-specific adverse / unanticipated events to date.
~Each vial contains a 2 milliliter (mL) dose of the injectable AAT. This volume is similar to other commonly used injectable filler materials intended for soft tissue correction."
15913799|NCT03544619|Other|Neuropathic Pain Symptom Inventory|Investigators will use the Neuropathic Pain Symptom Inventory for assessing neuropathic symptoms
15913800|NCT03544606|Drug|isosorbide mononitrate|isosorbide mononitrate group (study group) 70 patients are induced by Intra vaginal isosorbide mono nitrate at 36, 24 , 12 before induction
15913801|NCT03544606|Drug|Placebos|70 patients induced by placebo (pyridoxine) administered in the posterior vaginal fornix.
15913802|NCT03544593|Device|Revolve System|Fat grafting system
15913803|NCT03544580|Procedure|immediate implant with dentine chips|Using dentin chips
15913804|NCT03544580|Procedure|conventional immediate implant|using xenograft
15913805|NCT03544567|Drug|Oraxol|oral paclitaxel will be supplied in capsules and oral HM30181A-US in tablets
15913806|NCT03544554|Behavioral|a counseling and training program that consisted of a 45-minute presentation based on Pender's Health Promotion Model. Within the scope of the counseling and training program|The intervention group was provided with a counseling and training program that consisted of a 45-minute presentation based on Pender's Health Promotion Model.
15913807|NCT03544528|Procedure|Regeneration|Apical bleeding will be induced by passing a hand instrument beyond the apical foramen to allow blood filling in the canal. Mineral trioxide aggregate will be placed directly over the coagulated blood clot.
15913808|NCT03544515|Device|Er,Cr:YSGG laser|Application of Er,Cr:YSGG in peri-implantitis cases as a coadjutant has shown reduction in the pocket depths and bleeding on probing
15913809|NCT03544515|Procedure|Scaling|Scaling and debridement of the implant surface with hand scalers and curettes and an ultrasonic scaling unit (Cavitron -Dentsply Sirona)
15913810|NCT03544515|Device|Inactive Er,Cr:YSGG|Er,Cr:YSGG laser (inactive form - sham procedure) applied to the surface of the implant
15913811|NCT03544502|Device|CD player|CD player opened during anesthesia induction and continued until postoperative 15 minute
15913812|NCT03544502|Device|CEL-480 Sound Level Meter Sonometre|Noise level recordings were performed using CEL-480 Sound Level Meter Sonometre.
15913813|NCT03544502|Device|Earplug|the independent anesthesiologist placed earplug into the patients' ears during anesthesia induction and the ear plug were removed immediately before tracheal tube extubation.
15913814|NCT03544502|Procedure|Ambient operating room noise|patients were exposed to the ambient operating room noise.
15913815|NCT03544489|Behavioral|E-ICD Intervention|Home walking 3 days/week x 12 weeks
15913816|NCT03544476|Behavioral|Mobile phone TB treatment support app plus usual care|The behavioral intervention is delivered through a mobile phone TB support app. The functions allow the participant to: self-report daily administration of their TB medication, self-report side effects if applicable, review educational material on TB disease and its treatment, complete a treatment adherence monitoring test (urine drug metabolite test), take notes, and review their treatment progress/report. The drug metabolite test will require that the participant place a small amount of urine on the end of the paper strip, wait for results, and take a picture of the paper using the app. The purpose of this test is to confirm that medication was correctly taken within the past 24 hours.
15913817|NCT03544476|Other|Usual care|Usual care consists of outpatient treatment management from the time of diagnosis (unless symptoms are severe and hospitalization is recommended), routine clinical and laboratory tests, and follow-up appointments determined by the clinician. In general, patients receive 1-2 month's supply of medication and are asked to return monthly for follow-up.
15913818|NCT03544463|Device|iNAP® Sleep Therapy System|The iNAP® provides a pressure gradient within the oral cavity, which pulls the tongue toward the upper palate and pulls the soft palate forward in a way that enhances the patency of the upper airway near the pharynx so that upper airway patency can be maintained to prevent sleep-disordered breathing.
15913847|NCT03544229|Drug|TAK-906 Maleate Placebo|TAK-906 maleate placebo-matching capsules.
15913848|NCT03544216|Device|Multifocal Contact Lens|The multifocal contact lens (Bausch + Lomb ULTRA® for Presbyopia) will be worn for two weeks
15913849|NCT03544216|Device|Single Vision Contact Lens|The single vision contact lens (Bausch + Lomb ULTRA®) will be worn for two weeks
15913898|NCT03543748|Device|Sham Transcranial Magnetic Stimulation|The sham coil looks and sounds just like the real coil, but produces a negligible magnetic field.
15914093|NCT03542110|Drug|Alirocumab 150 MG/ML subcutaneous injection|Single-dose, pre-filled, disposable, subcutaneous injection pen
15913819|NCT03544450|Behavioral|Psychosocial counselling|"Individuals with psychological distress receive psychosocial counselling and enhanced usual care. The psychosocial the counselling process consists of: (i) introduction, explanation and rapport building; (ii) assessment of and understanding of the problem (including looking for positive assets); (iii) goal setting (asking the client what outcomes are preferred); (iv) problem management (exploring and identifying solutions, brainstorming, working with existing coping strategies, using social and cultural resources, and additional techniques such as relaxation and psycho-education); (v) implementation (making a plan of action and transition); and, finally, (vi) termination of counselling (including closing and follow-up). Enhanced usual care is provided by health workers, who have already been trained on diagnosis and treatment of common mental disorders, and usage of basic psychosocial counseling skills (communication, listening and basic emotional support)."
15913820|NCT03544450|Other|Enhanced Usual Care|Enhanced usual care is provided by health workers, who have already been trained on diagnosis and treatment of common mental disorders, and usage of basic psychosocial counseling skills (communication, listening and basic emotional support).
15913821|NCT03544437|Procedure|extraperitoneal laparoscopic extended retroperitoneal lymph node dissection|"All patients underwent extraperitoneal laparoscopic RNU with bladder cuff excision with concomitant extended RPLND performed by one of two urology surgeons at Renji Hospital.
~The anatomical boundaries of the lymph node dissection were deﬁned by the ipsilateral side of UUT-UC. In patients with right-sided UUT-UC, the template of dissection consisted of (i) right perihilar lymph nodes, (ii) paracaval lymph nodes, (iii) interaortocaval lymph nodes and (iv) right pelvic lymph nodes (common, external and obturator lymph nodes).
~In patients with left-sided UUT-UC, the template of dissection included (i) left perihilar lymph nodes, (ii) para-aortic lymph nodes, and (iii) left pelvic lymph nodes (common, external and obturator lymph nodes ). Lymph node specimens were sampled en bloc with surrounding adipose tissue, and were sent to pathological examination as individual packets with the surrounding adipose tissue."
15913822|NCT03544424|Other|No intervention|No intervention
15913823|NCT03544411|Biological|olive oil|the intervention consist of 15 ml / day of olive oil
15913824|NCT03544411|Biological|bran oil|the intervention consist of 15 ml / day of bran oil
15913825|NCT03544398|Other|robot assisted gait training|we use two types of robot assisted gait training and we will compare two groups.
15913826|NCT03544385|Drug|Ringers Solution|Treatment vs Placebo
15913827|NCT03544385|Drug|Placebo - Concentrate|treatment vs placebo
15913828|NCT03544372|Other|Assessment of Concussion History using NIH Concussion History Tool|NIH concussion tool
15913829|NCT03544359|Device|Transcranial electrical stimulation (tES)|"In tES, a mild electrical current is passed between two or more electrodes placed on the volunteer's head (scalp). In this study, a mild unvarying (constant) electrical 2mA current is passed between two rubber electrodes placed on the head over auditory cortex for 20 minutes per session for 5 consecutive days. Because the electrical current direction (positive/negative) and current amplitude (2mA) does not vary or change during stimulation, this type of tES is also called transcranial direct current stimulation, or tDCS."
15913830|NCT03544346|Other|Exploratory brain and general health assessment|Exploratory brain and general health assessment
15913831|NCT03544333|Device|transcranial magnetic stimulation|We will assess safety and efficacy of the following protocol: 1Hz of rTMS over the Sylvian parietal temporal area (area Spt) four times on 1 day (1 pulse/second and a total of 1'000 pulses: 16 minutes' protocol at 100 % of motor threshold modified based on Hoffman et al., 1999). Area Spt will be localized via baseline structural imaging and our Localite TMS navigation system.
15913832|NCT03544320|Device|Activity Monitoring-Wrist worn wearable|Participants wear an activity monitor on their wrist.
15913833|NCT03544320|Device|Activity Monitoring-Waist-worn wearable|Participants wear an activity monitor on their waist.
15913834|NCT03544307|Behavioral|Taekwondo training|Exercise group
15913835|NCT03544294|Device|Xience alpine, ultimaster, resolute onyx, synergy|PCI will be performed
15913836|NCT03544281|Drug|Belantamab mafodotin|Selected doses of belantamab mafodotin will be administered as an infusion.
15913837|NCT03544281|Drug|Lenalidomide|Lenalidomide will be administered as 25 or 10 mg,orally, with belantamab mafodotin and dexamethasone.
15913838|NCT03544281|Drug|Dexamethasone|Dexamethasone will be administered as 20 or 40 mg, orally with belantamab mafodotin.
15913839|NCT03544281|Drug|Bortezomib|Bortezomib will be administered as 1.3 mg/m^2, as SC or IV, with belantamab mafodotin and dexamethasone.
15913840|NCT03544268|Device|Acoustic Angiography|"Acoustic angiography imaging involves a research high frequency ultrasound scanner and a prototype transducer as well as conventional b-mode ultrasound to guide the location of the imaging. The conventional ultrasound will be conducted just prior to the acoustic angiography for localization. The imaging also requires administration of Definity ultrasound contrast agent.
~Acoustic angiography imaging will be performed by trained medical personnel using mild compression to eliminate motion. Total imaging time is estimated to be less than 15 minutes."
15913841|NCT03544268|Drug|Definity|Baseline B-mode US will be performed to confirm the lesions being imaged (unless it is a subject with no lesions, then a basic B-mode US will be performed). Perflutren is a diagnostic drug that is intended to be used for contrast enhancement. The vial contains a clear, colorless, sterile, non-pyrogenic, hypertonic solution which is activated by mechanical agitation with Vialmix®.It will be dispensed in inactivated form to a study team member. The contrast agent will be activated just prior to administration (ideally to be used within 5 minutes of activation). Contrast agent Definity will be activated according to package insert instructions, including use of VialMix®, the device used to activate Definity. Administration will occur IV in coordination with staff trained specifically in contrast ultrasound imaging.The total imaging time is anticipated to be less than 30 minutes.
15913842|NCT03544255|Procedure|Biopsy|Two extra EUS-FNA guided pancreatic biopsies collected for only research purposes.
15913843|NCT03544242|Other|Control|A saline infusion will be administered during the pre-isolation and post-isolation phases.
15913844|NCT03544242|Drug|Pre-Isolation Infusion|A nitrite infusion will be administered during the pre-isolation phase and a saline infusion will be administered during the post-isolation phase.
15913845|NCT03544242|Drug|Post-Isolation Infusion|A saline infusion will be administered during the pre-isolation phase and a nitrite infusion will be administered during the reperfusion phase.
15913846|NCT03544229|Drug|TAK-906 Maleate|TAK-906 maleate capsules.
15913850|NCT03544177|Other|BFR-Walking|Participants will perform 12 training sessions over 6 weeks, including a 10-minute warm up and cool down period. Patients will perform 5 six-minute bouts of over ground intermittent walking exercise (1-minute walk/rest) with their habitual walking device at a prescribed speed maintained by a metronome, starting from 60 steps/minute. A fixed resting period of 3 minutes will follow each walking bout. During walking, participants will wear BFR bands at both tights. Before every walking bout, the bands will be tightened at a low intensity (max 40% of blood systolic pressure) and untied at the end of every walking bout when patients will be asked to grade their RPE (Borg Scale). Walking speed will be weekly increased by 3 steps/minute, if the previous level was well-tolerated by the patient.
15913851|NCT03544177|Other|Conventional therapy|Participants will perform 12 training sessions over 6 weeks. Patients will perform assisted over-ground walking for a total of around 40 minutes, inserted between a 10-minute warm-up and cool-down period. The patient will be encouraged by the same experienced physiotherapist to walk back and forth on 50-meter indoor flat corridor with their habitual walking device. Patient will be asked to walk without stopping until reaching an effort corresponding to a value of 8 out of 10 of the rating of perceived exertion (Borg scale). When the exertion level is reached, the patients will be allowed to rest sitting on a chair if necessary; after a suitable rest period, when patients express sufficient desire to start again, the training will restart
15913852|NCT03544164|Other|Manual Ventilation|Manual ventilation via endotracheal tube using adult manual resuscitation device
15913853|NCT03544151|Device|Swan-Ganz Continuous Cardiac Output Thermodilutioon Cather (Swan-Ganz CCOmbo V)|Swan-Ganz CCOmbo V insertion
15913854|NCT03544138|Device|Hummingbird Tympanostomy Tube System (H-TTS)|The H-TTS is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure.
15913855|NCT03544125|Biological|Durvalumab|Given IV
15913856|NCT03544125|Drug|Olaparib|Given PO
15913857|NCT03544112|Behavioral|Employ a multifaceted approach to facilitate clinical protocol implementation|Implementation will include developing clinical protocols containing core components of the intervention to which fidelity is expected, along with aspects that may be adapted by local sites to aid implementation. In partnership with multidisciplinary teams at each site, we will adapt clinical practices from other contexts and available information about SL-BUP and XR-BUP to site-specific clinical protocols and implementation strategies. The study implementation facilitators will assist local champions to identify potential treatment providers and draw on existing resources for training and ongoing support.
15913858|NCT03544112|Drug|Initiate BUP (SL-BUP or XR-BUP) in the ED|The study implementation facilitators will assist local champions to identify potential treatment providers and draw on existing resources for training and ongoing support.
15913859|NCT03544099|Drug|Pembrolizumab|Pembrolizumab 200mg Intravenous Solution
15913860|NCT03544073|Drug|Saline Solution for Injection|Placebo arm will receive a saline injection
15913861|NCT03544073|Drug|Leuprolide Acetate|Treatment arm will receive a Leuprolide injection
15913862|NCT03544060|Drug|Volanesorsen|Volanesorsen administered by subcutaneous (SC) injections in the abdomen, thigh, or upper arm.
15913863|NCT03544047|Drug|Paclitaxel|Patient was first treated with paclitaxel (PTX) chemotherapy 3 cycles (2 weeks regimen). If the tumor continues to reduce in the first 3 cycles, continue paclitaxel chemotherapy for 3 cycles (6 weeks).
15913864|NCT03544034|Behavioral|HomeTeam Toolkit|"A multi-component intervention (8S's)
~Safety at home through partnership.
~Safety risk assessment at the admission
~Safety agenda setting for coordinating efforts among professionals to prepare patient/ family for self-management
~Safety tools. Cognitive tools to support patient/family after discharge
~Safety education. Enhanced Patient/ family medication safety education
~Safety briefings with patient/family A mechanism to proactively address common and patient/family specific risks.
~Safety through learning routines across the care continuum
~Safety assessment after discharge"
15913865|NCT03544021|Biological|CART-19 cells|CD19-Targeted CAR-T cells are infused to patient received FC chemotherapy
15913866|NCT03544008|Other|The use of AXIOS in Endoscopic transmural drainage|
15913867|NCT03543982|Dietary Supplement|Oral probiotic product|Once per day (QD), 28 days
15913868|NCT03543969|Drug|Vemurafenib|Vemurafenib will be dosed at 960 mg by mouth (PO) twice a day (BID).
15913869|NCT03543969|Drug|Cobimetinib|Cobimetinib will be dosed at 60 mg daily.
15913870|NCT03543956|Behavioral|Questionnaire|Questionnaire
15913871|NCT03543943|Procedure|Individualized treatment of Acute Achilles tendon rupture.|The most proximal border of the calcaneus and the most distal point of the musculotendinous junction of the medial gastrocnemius muscle is identified and marked on the skin. These two points on the un-injured leg defines the original length of the total Achilles tendon [1]. The difference in length between the injure and the un-injured leg determines elongation for the ruptured Achilles tendon. The relative elongation of the ruptured tendon together with overlap of the tendon ends on the cross-sectional area determines the treatment for the patients receiving individualized treatment: 1) patients with 0-6% elongation of the tendon and a minimum of 25% tendon are treated non-operatively 2) patients with 7% elongation or more or less than 25% tendon overlap are treated operatively.
15913872|NCT03543943|Procedure|Non-operative treatment|Circulated cast below the knee in maximal, unforced plantar flexion over the ankel.
15913873|NCT03543943|Procedure|Operative treatment|Open surgery with suture of the ruptured achilles tendon prior to circulated cast below the knee in maximal, unforced plantar flexion over the ankel.
15913874|NCT03543930|Device|Postoperative preventive CPAP|Administration of a course of 2 hours of CPAP with 7.5 cmH2O pressure and 0.30 FIO2
15913875|NCT03543917|Combination Product|Perfusion with New Combination Medication|Intravenous administration of Actovegin, vitamins B1, B6, B12, C, oxytocin/dexamethasone, calcium gluconate, etc in 250 ml normal saline administered during approximately 2 hours
15913876|NCT03543904|Procedure|Pre-operative physiotherapy education|"Pre-operative education regarding post-operative physiotherapy intervention in children with abdominal surgery which includes,
~Deep breathing exercises
~Pursed lip breathing exercises
~Diaphragmatic breathing exercises
~Leg ROM (active hip and knee flexion, extension and abduction exercises)
~Ankle toe movements exercises"
15913877|NCT03543904|Procedure|Post-operative physiotherapy intervention|"Post-operative physiotherapy intervention which includes,
~Deep breathing exercises
~Pursed lip breathing exercises
~Diaphragmatic breathing exercises
~Leg ROM (active hip and knee flexion, extension and abduction exercises)
~Ankle toe movements exercises"
15913878|NCT03543878|Device|Flicker|The Flicker intervention is delivered with the GammaSense Stimulation System by Cognito Therapeutics and involves viewing flickering lights at gamma frequency (like a strobe light but faster) to drive gamma oscillations in visual brain areas. The GammaSense Stimulation System is a device consisting of a pair of opaque glasses with a light-emitting diode (LED) illumination on the interior of the glasses. Headphones worn by the user during the stimulation session provide the auditory stimulation. When activated for the treatment session, the device will generate light and sound oscillations at 40 cycles per second (Hz) for 60 minutes. Participants will use the device daily during their active treatment period.
15913879|NCT03543865|Behavioral|New Hope (NH)|New Hope will be implemented over 1 visit (2-4 hours) in a youth-preferred setting after Emergency Department (ED) discharge for a suicide attempt, and in the past few years has been updated to also target suicide ideation and binge behavior. NH emphasizes the seriousness of a suicide attempt; teaches coping skills to reduce risk, including emotion regulation, cognitive restructuring, social support, and safety planning; and helps participants overcome barriers to treatment motivation, initiation, and adherence. A center-piece of the intervention is a 20-minute video produced by with Native actors, vignettes specific to this community, and Elders speaking in Apache (with sub-titles) about the seriousness of suicide, its impact on the community, their concern for the adolescent, and beliefs about the communal importance of each individual's life.Youth will be encouraged to choose a support person from his/her family to take part in the intervention.
15913880|NCT03543865|Behavioral|Elders Resilience (ER)|Elders' Resiliency is a monthly manualized curriculum taught by Elders in the community intended to bolster Apache youths' resilience to suicide ideation, attempts and substance abuse by promoting Apache cultural identity and values, youth's self-worth and role in the community, and fostering connectedness to society and community, with an emphasis on extended family as a nexus of strength. Each lesson introduces youth to cultural knowledge, stories, and songs with an emphasis on respect and the sacredness of each life. Our community-based Apache staff will select Elders who both express an interest in the current project and have demonstrated affinity and skill for teaching the current curriculum in the schools. After this group of Elders is recruited and agree to participate, they will be paired with our paraprofessional Apache study staff.
15913881|NCT03543865|Other|Case Management (CM)|Research Program Assistants, who are trained Surveillance System Staff, will conduct the monitoring and case management visits in participants' homes or other private settings at baseline, 1, 2, 3 and 6 months post-enrollment. The CM visit includes rapport-building, use of the Suicide Ideation Questionnaire (SIQ) to assess imminent risk, and if youth report not yet having connected to services, referral to Apache Behavioral Health Services (ABHS), the local community mental health center. At CM visits, the Research Program Assistants will also monitor participants' completion of the study battery, which will be self-administered using tablets. In addition, Research Program Assistants will score the SIQ before leaving the youth. If the SIQ reveals the participant is at imminent risk, Research Program Assistants will employ a protocol for rescue services, which involves triaging youth immediately to the ED for further assessment and care.
15913882|NCT03543852|Behavioral|SurvivorLink|SurvivorLink (www.cancersurvivorlink.org) was developed in 2010 as a HIPAA compliant web-based communication tool to enable survivors to learn about survivorship care, store their SHP and other important health documents, and share their SHP and other health documents with their various healthcare providers. Once the registrant creates their health record, they can upload and store their important health documents and electronically share their health record with their providers. Other key features include a provider directory for patients to find physicians knowledgeable of survivor care, additional patient/parent material available in English/Spanish, and additional continuing medical education (CME) modules for providers to learn about survivor care.
15913883|NCT03543839|Biological|Belimumab|Subjects in this arm will receive 200mg belimumab subcutaneously weekly for 2 years
15913884|NCT03543839|Biological|Belimumab/Placebo|Subjects in this arm will receive weekly subcutaneous injections of 200mg belimumab for 1 year and then placebo subcutaneous injections for 1 year.
15913885|NCT03543839|Other|Placebo|Subjects in this arm will receive weekly subcutaneous injections of placebo for 2 years
15913886|NCT03543826|Other|Protocol for rocuronium neuromuscular block|The protocol includes specified appropriate rocuronium dosing and a valid pre-reversal assessment of the adductor pollicis response guides optimal neostigmine vs. sugammadex reversal.
15913887|NCT03543813|Drug|CX-2029|CX-2029 Monotherapy
15913888|NCT03543800|Device|Cytorich PRP kit|Subjects randomized to the PRP treatment arm will receive PRP only without the anti-inflammatory component of ABP added
15913889|NCT03543800|Device|PRP kit|PRP kit legally marketed in Canada for PRP
15913890|NCT03543787|Combination Product|Health IT and Peer Support Intervention|"Health IT will support referral system by establishing 1) communication between healthcare providers and peer navigators 2) decision support for clinician to facilitate appropriate referrals 3) tracking of referred patients real-time 4) dashboards to monitor key evaluation metrics.
~Peer Support intervention: peer navigators at each level of the referral network will ensure 1) referral adherence by link clinicians and patients 2) health system navigation 3) psychosocial support: leverage their shared disease experience to help patients overcome barriers to health seeking behaviour."
15913891|NCT03543774|Drug|Simvastatin 40mg|Simvastatin mono-therapy at the dose of 40 mg/day for 12 months
15913892|NCT03543774|Drug|Ezetimibe/simvastatin 10/20 mg/day|Ezetimibe/simvastatin combined therapy at the dose of 10/20 mg/day for 12 months
15913893|NCT03543774|Drug|Ezetimibe/simvastatin 10/40 mg/day|Ezetimibe/simvastatin combined therapy at the dose of 10/40 mg/day for 12 months
15913894|NCT03543761|Device|Dornier Aries 2 device|• Sham group: 6 sessions with placebo LiST probe, 1 session per week. A specific probe design, identical to the active one will allow the double blind fashion of the study.
15913895|NCT03543761|Device|Dornier Aries 2 device|LiST groups: 6 sessions with active LiS probe, 1 session per week. The ARIES 2 device by Dornier will be used with a treatment protocol: 5000 SW, energy flux density = 0.096 mJ/mm2 (energy level 7)
15913896|NCT03543761|Device|Dornier Aries 2 device|LiST groups: 6 sessions with active LiS probe, 1 session per week. The ARIES 2 device by Dornier will be used with a treatment protocol: 5000 SW, energy flux density = 0.096 mJ/mm2 (energy level 7)
15913897|NCT03543748|Device|Transcranial Magnetic Stimulation|A total of 2000 trains will be delivered successively. The pulses will be delivered at 80% of motor thresholds.
15945283|NCT03300609|Drug|Leucovorin Calcium|Given IV
15913899|NCT03543735|Behavioral|Wisepill+SMS|This will include: 1) an in-person Wisepill orientation session to introduce the pillbox and generate relapse prevention messages that can be later delivered during non-adherent windows; 2) use of the Wisepill device during the intensive treatment program and after discharge; and 3) three forms of tailored SMS messages paired with Wisepill device use: a) supportive messages with medication compliance, b) reminder messages for early non-adherence (e.g., 1 hour late) and c) relapse-prevention messages after longer periods of non-adherence (e.g., several hours).
15913900|NCT03543735|Other|Wisepill-only|This will include: 1) an in-person Wisepill orientation session to introduce the pillbox; 2) use of the Wisepill during the intensive treatment program and after discharge.
15913901|NCT03543722|Behavioral|National Career Coach Program|Intensive employment services as described above.
15913902|NCT03543722|Behavioral|Local Community Resources Program|Usual employment services as described above.
15913903|NCT03543709|Diagnostic Test|fibromyalgia 2013 criteria|Frequency of fibromyalgia will be investigated in women diagnosed with Behcet disease
15913904|NCT03543709|Other|Behcet's disease current activity form|Disease activity will be investigated in women with Behçet's disease without fibromyalgia.
15913905|NCT03543696|Radiation|Single Dose Radiotherapy (SDRT)|
15913906|NCT03543683|Drug|Osimertinib|Osimertinib, also known as azd9291, is a 3rd-generation EGFR-TKI used to treat NSCLC patients with resistance to 1st generation EGFR-TKI due to T790M mutation. It has been approved in clinical applications by the FDA in 2015.
15913907|NCT03543683|Drug|Aspirin|Aspirin, also known as acetylsalicylic acid (ASA), is a very safe medication used to treat pain, fever, or inflammation.
15913908|NCT03543670|Dietary Supplement|Oncoxin-Viusid|Support treatment with Oncoxin-Viusid (75mL/day) during chemotherapy/Radiotherapy until two weeks after (a total of 8 months).
15913909|NCT03543657|Drug|Molidustat (BAY85-3934)|Starting dose of molidustat will be titrated based on the subject's Hb (Hemoglobin) response. Administrated orally once daily (OD).
15913910|NCT03543657|Drug|Darbepoetin alfa|Starting dose of darbepoetin alfa will be titrated based on the subject's Hb (Hemoglobin) response. Administrated weekly or once every two weeks by intravenous injection.
15913911|NCT03543657|Drug|Placebo of Molidustat (BAY85-3934)|Matching placebo of Molidustat.
15913912|NCT03543657|Drug|Placebo of Darbepoetin alfa|Matching placebo of Darbepoetin alfa.
15913913|NCT03543644|Other|Sugar-sweetened beverage (SSB)|SSBs will be provided to each participant. Participants will be able to choose their SSB of choice from the list in the protocol. They will be instructed to drink their usual SSB intake, study drinks provided, while freely consume their usual background diets. They will revert to their usual SSB intake during wash-out phase during which they will not receive any beverage drinks from the study.
15913914|NCT03543644|Other|Non-nutritive sweetened beverages (NSB)|NSBs will be provided to each participant. Participants will be be given the NSB equivalent to the usual SSB chosen from the list in the protocol. They will be instructed to replace their usual SSBs with the NSBs while freely consume their usual background diets. They will revert to their usual SSB intake during wash-out phase during which they will not receive any beverage drinks from the study.
15913915|NCT03543644|Other|Water|Water will be provided to each participant. They will be instructed to replace their usual SSBs with the water while freely consume their usual background diets. They will revert to their usual SSB intake during wash-out phase during which they will not receive any beverage drinks from the study.
15913916|NCT03543631|Other|Survey|Online survey
15913917|NCT03543618|Device|Sloped|Placement of implant with sloped design
15913918|NCT03543618|Device|Control|Placement of implant with conventional design
15913919|NCT03543605|Behavioral|PROA Experimental|PROA Control plus clinical advice
15913920|NCT03543605|Other|PROA Control|PROA Control
15913921|NCT03543592|Diagnostic Test|3 dimensional ultrasonography and Doppler|Three-Dimensional images will be recorded. The volumes will be generated by the automatic rotation of the mechanical transducer 360 degrees. Visualization of the endometrium and myometrium in the three planes will be done to detect endometrial cavity and any lesions. The power Doppler gate will be activated for blood flow mapping of the endometrium and endometrial-myometrial interface (sub-endometrial area). The pulsed Doppler sample volume will be activated to obtain a flow velocity waveform (FVW). Vascularization index (VI), flow index (FI) and vascularization-flow index (VFI) will be automatically calculated from three consecutive FVWs.
15913922|NCT03543553|Other|This is not an intervention study|This is not an intervention study
15913923|NCT03543540|Biological|Nexvax2|Nexvax2 injections: 14 in total at twice weekly intervals
15913924|NCT03543540|Biological|Placebo|Placebo injections: 14 in total at twice weekly intervals
15913925|NCT03543527|Other|no intervention|no intervention
15913926|NCT03543514|Other|TRIMODAL PREHABILITATION|"Trimodal prehabilitation application in the form of:
~Control with the 6-minute walking test and podometer of physical activity
~Dietary advice to be able to perform a hyperproteic diet
~Mindfullnes to improve the emotional level."
15913927|NCT03543501|Device|Real-time ultrasound imaging feedback|Participants will be taught about the anatomy of abdominal wall muscles and the general functioning of RUSI (5 mins). Then, they will be invited to take the supine position, knees flexed. The feedback will consist of an ultrasound image transmitted to a brightness (B)-mode. Participants will receive the necessary education to understand the image and the desired recruitment according to a standardized protocol. They will then be asked to perform 15 contractions held 10 seconds of the TrA with a visible thickening of the TrA on the RUSI monitor exceeding the measurement at rest (visible on the monitor). Forty-five seconds rest will be allowed between each contraction to avoid fatigue. Participants will have to watch the RUSI monitor during the 15 tests.
15913928|NCT03543501|Device|PBU feedback|Participants will receive the same instruction on the anatomy of abdominal wall muscles and general information about the PBU device. They will be invited to take the same position as for the RUSI group (supine, knees flexed). The feedback will be to visualize the intensity of pressure on the dial of a STABILIZER PBU (Chattanooga Group, Hixon, TN). Participants will receive the education necessary to understand the tool and the desired recruitment according to a standardized protocol. They will then be asked to perform 15 contractions of the TrA with a duration of 10 seconds while maintaining the constant pressure at 40 mmHg ± 2 mmHg. Forty-five seconds of rest will be allocated between each contraction. Participants will have to watch the PBU dial during the 15 tests.
15945284|NCT03300609|Drug|Fluorouracil|Given IV
15913929|NCT03543488|Diagnostic Test|Neuromuscular and functional capacity tests|"The Timed Up and Go test; Maximal knee-extensor muscle strength (isometric and concentric tests) was measured with a Biodex System 3 dynamometer; A B-mode ultrasonography system with a linear-array probe (60 mm, 7.5 MHz) was used to determine VL and RF muscle thickness, pennation angle, fascicle length and tendon CSA. Measurements were obtained with the volunteer seated in the dynamometer, during isometric contraction at 90° of knee flexion.
~An 8-channel EMG system was synchronized with the dynamometer through a Windaq data acquisition system and used to evaluate the vastus lateralis and rectus femoris electrical activity during isometric knee-extensor tests."
15913930|NCT03543475|Device|arabin pessary|arabin pessary: silicon device
15913931|NCT03543475|Device|no pessary|control group
15913932|NCT03543462|Device|thoracic Drain Tube 24 Fr.|Positioning of Thoracic Drain after diaphragmatic resection and consequently diaphragmatic repair
15913933|NCT03543449|Other|Off-Pump Coronary Artery Bypass (OPCAB) surgery|Off-Pump Coronary Artery Bypass (OPCAB) surgery. This study is retrospective study
15913934|NCT03543436|Drug|Temocillin|Intravenous temocillin disodium 2g intravenously/8h Or Renally Adjusted Equivalent (ORAE) in 30-40 min infusion or continuous intravenous (6g/24h) .
15913935|NCT03543436|Drug|meropenem or imipenem|Intravenous carbapenem (meropenem 1g intravenously/8h Or Renally Adjusted Equivalent (ORAE) or imipenem 1g intravenously/8h ORAE)
15913936|NCT03543423|Other|Oral glucose tolerance test|Oral glucose tolerance test will be carried out with a glucose solution made up of 75g glucose dissolved in 300mL. To the glucose solution will be added 5g 3-OMG and 1g paracetamol 5g 3-OMG
15913937|NCT03543423|Other|Liquid mixed meal test|A standardised liquid mixed meal test will be carried out using a standard liquid mixed meal (fresubin drink supplemented with 1g paracetamol).
15913938|NCT03543410|Drug|SEP-4199 200 mg|SEP-4199 200 mg/day (supplied in two 100mg tablets)
15913939|NCT03543410|Drug|SEP-4199 400 mg|SEP-4199 400 mg/day (supplied in two 200mg tablets
15913940|NCT03543410|Drug|Placebo|Placebo (supplied in two tablets/day)
15913941|NCT03543371|Diagnostic Test|Neuropsychological assessment|Standardized neuropsychological battery consisting of the following tests and questionnaires: Wechsler Adult Intelligence Scale - Fourth Edition (WAIS-IV) Vocabulary, Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency, WAIS-IV Block Design, WAIS-IV Matrix Reasoning, WAIS-IV Digit Span, Wechsler Memory Scale - Third Edition (WMS-III) Spatial Span, Rey Auditory Verbal Learning Test (RAVLT), WMS-III Logical Memory, Brief Visuospatial Memory Test-Revised (BVMT-R), Trail Making Test (TMT) A & B, D-KEFS Color Word Interference Test, Behavioral Assessment of the Dysexecutive Syndrome Dysexecutive Questionnaire (BADS DEX), Multidimensional Fatigue Inventory (MFI-20), Minimal Insomnia Symptom Scale (MISS), Hospital Anxiety and Depression Scale (HADS).
15913942|NCT03543358|Drug|rovalpituzumab tesirine|Optional retreatment with rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) administered intravenously once every 6 weeks beginning on Day 1 (day of dosing) for 2 dose cycles
15913943|NCT03543358|Drug|rovalpituzumab tesirine|Rovalpituzumab tesirine (0.3 mg/kg or previously adjusted dose) administered intravenously once every 6 weeks beginning on Day 1 (day of dosing). Subjects will receive rovalpituzumab tesirine on Day 1 of each 6-week cycle, omitting every third cycle until disease progression or study drug discontinuation.
15913944|NCT03543345|Diagnostic Test|echocardiography study|"Patients with right coronary artery occlusion lesion will be subjected to:
~Written consent.
~Complete history.
~Complete physical examination.
~Trans-thoracic echocardiography assessment of the right ventricular function before PCI to the RCA
~Follow up Trans-thoracic echocardiography assessment of the right ventricular function four weeks after the PCI."
15913945|NCT03543332|Diagnostic Test|Measures of physical activity and kinesiophobia|Groups will be compared regarding kinesiophobia with TSK heart.
15913946|NCT03543306|Drug|daborafenib plus trametinib|Dabrafenib 150 mg twice daily and trametinib 2 mg once daily
15913947|NCT03543267|Other|MRI exam|MRI before and after resection surgery
15913948|NCT03543254|Drug|BoNT-A|"90U BoNT-A, given in one treatment as 18 injections of 5u (0.2 ml) each, on specific preselected sites along the sutures of the skull.
~First 100 U of Botox® is solved in 4 ml (cc) of isotone saline water (9 mg/ml), distributed in 4 syringes. This is half the usual concentration, allowing for better diffusion in order to reach the target structures."
15913949|NCT03543241|Diagnostic Test|MyoStrain|Prior to cardiac catheterization, patients will be stress testing with low dose Dobutamine to evaluate wall motion, segmental, and global myocardial strain at rest and under stress to determine the accuracy of detecting ischemia and viability of myocardial tissue.
15913950|NCT03543228|Diagnostic Test|MyoStrain|MyoStrain quantifies myocardial contraction to detect changes in heart function during chemotherapy.
15913951|NCT03543215|Other|Radiomics: Analysis of textural features of imaging (MRI and Ultrasound)|All patients with confirmed endometrial cancer will have received Ultrasound and MRI as part of routine standard of care. Textural features from this will be analysed to see if can predict prognosis.
15913952|NCT03543202|Drug|Transversus abdominis plane block|will receive 20ml bupivacaine for Transversus abdominis plane block and intravenous patient controlled analgesia
15913953|NCT03543202|Drug|local infiltration anesthesia|will receive 20ml bupivacaine for local infiltration anesthesia and intravenous patient controlled analgesia
15913954|NCT03543202|Drug|Intravenous patient controlled analgesia|will not receive any regional anesthetic intervention will receive intravenous patient controlled analgesia
15913955|NCT03543189|Drug|Nivolumab|Treatment with nivolumab will begin four weeks prior to the first brachytherapy treatment. Nivolumab will be given through a vein every 2 weeks for 4 courses. Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody that binds to the PD-1 receptor and blocks its interaction with PD-L1 and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response, resulting in decreased tumor growth.
15913956|NCT03543189|Radiation|Brachytherapy|High dose rate (HDR) Brachytherapy involves the delivery of a high dose of radiation, internally, directly to the prostate. This procedure is completed in one day as an outpatient procedure.
15913957|NCT03543189|Radiation|External Beam Radiation Therapy|External beam radiation therapy to the participant's prostate will be given once a day, five days a week (Monday-Friday), for a total of five weeks. External radiation therapy treatments are given as an outpatient procedure and take about 10-15 minutes each day.
15913958|NCT03543189|Drug|Androgen Deprivation Therapy|Standard of care.
15945285|NCT03300609|Drug|Capecitabine|Given PO
15913959|NCT03543176|Other|UMEC/VI|UMEC/VI as 62.5/25 mcg, which is a once-daily single inhaler dual therapy, given to subjects, via Ellipta .
15913960|NCT03543176|Other|FLUT/SAL|FLUT/SAL as 250/50 mcg, which is a twice-daily single inhaler dual therapy, given to subjects, via Diskus.
15913961|NCT03543176|Other|CAT|Questionnaire used to asses Condition-related well-being, for COPD subjects.
15913962|NCT03543176|Other|mMRC|Questionnaire used to asses Breathlessness, due to Dyspnea, for COPD subjects.
15913963|NCT03543176|Device|Ellipta|It is a single once daily, Dry powder Inhaler (DPI), developed for delivery of therapies in COPD subjects.
15913964|NCT03543176|Device|Diskus|It is a plastic device containing twice-daily single inhaler dual therapy, developed for delivery of therapies in COPD subjects.
15913965|NCT03543163|Procedure|Non- Pedicled Buccal Fat Pad with Coronally Advanced flap|A horizontal incision of 1.5cm in long will be made at the bottom of the vestibule with the #15 blade in the region of maxillary first and second molars, depending on side of the recipient site. A curved hemostat will be used in the blunt dissection through the buccinators muscle to temporarily reposition and loose the surrounding fascia which will allow the buccal fat pad to be exposed in the oral cavity. A portion of adipose tissue equals to the required graft size will be excised with the microsurgical scissors. The grafting material will be placed on a saline-soaked gauze until its transfer to the recipient site. Finally, the patient's check will be compressed, in order to promote the closure of the wound edges then immediately close the donor site with simple 5.0 silk thread interrupted sutures
15913966|NCT03543163|Procedure|sub-epithelial connective tissue graft|a sub- epithelial connective tissue graft is harvested from the hard palate is used to treat area with gingival recession
15913967|NCT03543150|Drug|BOTOX|BOTOX injections will be administered to eligible subjects with diagnosis of spasmodic dysphonia. Dose unit, daily dose frequency, date of administration will be at the investigator discretion.
15913968|NCT03543137|Drug|Nicotine Prototype Mini lozenge|A single dose of a prototype nicotine 4mg lozenge will be placed in participants mouth, occasionally moving it side to side. Allowing it to slowly dissolve and try to minimize swallowing. Participants will be instructed not to chew lozenge. The lozenge should be completely dissolved.
15913969|NCT03543137|Drug|Nicorette Mini Lozenge|A single dose of a 4 mg nicotine polacrilex mini lozenge (Nicorette Minis) will be placed in participants mouth, occasionally moving it side to side. Allowing it to slowly dissolve and try to minimize swallowing. Participants will be instructed not to chew lozenge. The lozenge should be completely dissolved.
15913970|NCT03543124|Device|cap|A commercially available transparent cap (Olympus) will be fitted to the end of the colonoscope.
15913971|NCT03543124|Other|Water|Using water instead air to help insertion
15913972|NCT03543111|Behavioral|Zest|Zest is an internet-based psychological health enhancement program for women with spinal cord injury. The intervention will occur in Second Life (SL), which is an online virtual word simulator with a group of women with spinal cord injury.The Zest program will consist of 10 weekly 2-hour group sessions with approximately 8 women using avatars to represent themselves.
15913973|NCT03543098|Procedure|Early Surgery|Subjects will undergo surgery within 6 weeks after injury.
15913974|NCT03543098|Procedure|Delayed Surgery|Subjects will undergo surgery 12 to 16 weeks after injury.
15913975|NCT03543098|Procedure|Early Rehab|Subjects will undergo rehabilitation that will include unrestricted range of motion exercises and use of a weightbearing as tolerated gait starting after the first post-operative visit with the surgeon.
15913976|NCT03543098|Procedure|Delayed Rehab|Subjects will undergo rehabilitation that will include use of a knee brace locked in extension, no range of motion exercises and use of non-weightbearing gait for the first 4 weeks after surgery.
15913977|NCT03543085|Device|GiMer Medical MN 1000 External Stimulator|Trial stimulator (GiMer Medical Model 1000 External Stimulator) to generate pulsed ultrahigh frequency (>200KHz) electrical stimulation, delivered via lead in epidural space, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range.
15913978|NCT03543072|Drug|Bisphosphonates|a class of drugs that prevent the loss of bone density, used to treat osteoporosis and similar diseases
15913979|NCT03543059|Drug|GnRH analogue|gonadotrophin releasing hormone analogue
15913980|NCT03543046|Device|Tortle Midliner|The Tortle Midliner will be applied in the treatment group within the first 3 hours of life and maintained until 72 hours of life.
15913981|NCT03543033|Drug|Corticosteroid injection|These subjects will first receive a topical anesthesia to the skin and underlying tissue in a maximum amount of 5 ml of 1% Lidocaine. Following this application, an 18-20 gauge epidural needle will be used to inject a solution containing 80 mg Depo-Medrol in 1 ml of 1% PF Lidocaine and 5ml of sterile PF saline
15913982|NCT03543020|Radiation|radiation therapy to brain|OSL placed over the scalp for initial 5 fractions for patients undergoing partial/ whole brain radiation therapy
15913983|NCT03542994|Other|EDP1066|EDP1066 is an orally administered monoclonal microbial
15913984|NCT03542994|Drug|Placebo oral capsule|placebo
15913985|NCT03542981|Device|Interferential Current|
15913986|NCT03542981|Device|Sham Interferential Current|
15913987|NCT03542968|Procedure|magnetic resonance imaging|Acquisition 4D Flow magnetic resonance Imaging-8 minutes
15913988|NCT03542955|Device|ActiPatch|A Pulsed Shortwave Therapy Device
15913989|NCT03542955|Drug|Etoricoxib 60 mg|nonsteroidal anti-inflammatory drug used as standard therapy
15913990|NCT03542942|Other|treatment with EXIT-target volume|exclusion of the unaffected part of the uterus out of the treatment field
15913991|NCT03542929|Device|whole body vibration|whole body vibration training on a vibrating platform with healthy elderly and diabetic elderly
15913992|NCT03542916|Drug|CJ-40001 60ug|CJ-40001 60ug SC, IV injection
15913993|NCT03542916|Drug|NESP 60ug|NESP 60ug SC, IV injection
15914033|NCT03542630|Other|blood tests|All female participants who do not have recent blood tests will make new blood tests to determine certain blood parameters.
15914034|NCT03542617|Drug|Dexamethasone|
15914035|NCT03542617|Drug|Normal Saline Solution|
15914062|NCT03542383|Device|High Definition Transcranial Direct Current Stimulation|Administer 1 ma anodal HD tDCS over the preSMA for 20 minutes a session for 10 sessions over a two week period
15914094|NCT03542110|Drug|Matching Placebo subcutaneous injection|Single-dose, pre-filled, disposable, subcutaneous injection pen
15913994|NCT03542903|Device|Electroconvulsive therapy|"Electroconvulsive therapy is administered through electrodes positioned bilaterally (for quicker efficacy) on the frontotemporal region.
~The stimulation dose is determined by titration method, during the first ECT session.
~The dose for therapeutic stimulation will be twice the seizure threshold. This dose may be increased as the crisis does not meet the effectiveness criteria, as is recommended.
~For patients undergoing ECT, an intravenous injection of etomidate (between 0.1 and 0.7 mg/kg) and suxamethonium chloride (0.8 and 1.2 mg/kg) is performed. The required doses are adapted according to each patient by the anaesthetist and they are documented in the patients' files. A mixture of etomidate and propofol can be used in second-line or just propofol in third-line (no more than 2mg/kg)."
15913995|NCT03542890|Device|Baska Mask|used in adult low risk females undergoing elective gynecological operations
15913996|NCT03542890|Device|I-gel|used in adult low risk females undergoing elective gynecological operations
15913997|NCT03542877|Drug|Oral Tablet: Cabozantinib|Patients will take 60mg cabozantinib, by mouth, once daily, every day for 12 weeks. This medication should be taken on an empty stomach. Patients should not eat 2 hours before or 1 hour after taking cabozantinib. Only water is permitted during this 3 hour time frame.
15913998|NCT03542864|Dietary Supplement|Nasogastroduodenal Protocol|Complete nutrition (carbohydrates, lipids, proteins, vitamins, oligoelements)
15913999|NCT03542864|Other|Control|Progress registration of body composition values
15914000|NCT03542864|Other|Data analysis|Statistical analysis of all data
15914001|NCT03542851|Drug|Pentetrazol (PTZ)|BTD-001 is an oral capsule of PTZ.
15914002|NCT03542851|Drug|Placebo oral capsule|Placebo will be presented as oral capsule.
15914003|NCT03542838|Drug|Resiniferatoxin|Resiniferatoxin is a compound purified from natural sources.
15914004|NCT03542838|Drug|Saline|Saline is a normal physiological solution
15914005|NCT03542825|Drug|Lactoferrin|parallel use of the three drugs to compare the efficacy of each arm in prevention of anemia
15914006|NCT03542825|Drug|Iron Supplement|Iron Sulphate 150 mg once daily
15914007|NCT03542825|Drug|Chelates, Iron|Amino acid chelated iron capsules contain 15 mg
15914008|NCT03542812|Drug|L-Citrulline|The L-citrulline will be procured in powder form and will be solubilized in sterile water to achieve a concentration of 50 mg/ml. Therefore, 3 ml/kg of the solubilized L-citrulline (50 mg/ml) will be administered per dose for the single-dose groups and the dose administered to the steady-state group will be determined from results from the single-dose studies.
15914009|NCT03542799|Biological|EGFR IL12 CART|EGFR IL12 CART cells will be administered using a split dose on day0 (10%),1(30%), and 2(60%)
15914010|NCT03542786|Dietary Supplement|Probiotic|"The probiotic i3.1 is a commercialized product. It will be supplied by the promoter and manufactured in ALIFARM S.A.
~It contains:
~Lactobacillus plantarum CECT7484
~Lactobacillus plantarum CECT7485
~Pediococcus acidilactici CECT7483"
15914011|NCT03542786|Dietary Supplement|Prebiotic|"ProSeed prebiotic is a non-commercialized product. It will be supplied by the promoter and manufactured in ALIFARM S.A.
~It contains:
~Partially Hydrolyzed Guar Gum (PHGG)
~Inulin HPD
~Oat Beta-Glucans
~Pectin
~Inulin Low Protein Diet (LPD)
~Polydextrose
~Maltrodextrins"
15914012|NCT03542786|Dietary Supplement|Placebo|It is a non-commercialized product. It is composed of the same excipients as the probiotic and the prebiotic. It will be supplied by the promoter and manufactured in ALIFARM S.A.
15914013|NCT03542773|Drug|18F-DCFPyL Injection|18F-DCFPyL with whole body PET/CT scan
15914014|NCT03542760|Drug|Methylene Blue|Administration of methylene blue as per the treating physician's diagnosis and the acute care facility's standard of care
15914015|NCT03542747|Device|Time to ventilation with the iLTS|Time to ventilation (ET) based of insert the iLTS until the chest rise of the simulator in seconds
15914016|NCT03542747|Device|Time to ventilation with the Fastrach|Time to ventilation (ET) based of insert the Fastrach until the chest rise of the simulator in seconds
15914017|NCT03542734|Other|multimodal magnetic resonance imaging|multimodal magnetic resonance imaging included T1, FLAIR, MRA, PWI and/or ASL, DTI, DKI, SWI, fMRI
15914018|NCT03542721|Drug|DA-5515|Crataegi ethanol extract, Garlic oil, Ginkgo leaf extract, Melissa folium extract (three times a day)
15914019|NCT03542721|Drug|Placebo of DA-5515|Placebo (three times a day)
15914020|NCT03542708|Procedure|A-PRP|The cortex of selected ovary will be injected with autologous platelet rich plasma. Up to ten different sites will be injected under ultrasound guidance. The patient will be under IV sedation. Record of which ovary was injected will be kept in the online research database and not in the clinical chart.
15914021|NCT03542695|Procedure|Computed Tomography|Undergo PET/CT
15914022|NCT03542695|Drug|Copper Cu-64-DOTA-alendronate|Given IV
15914023|NCT03542695|Other|Pharmacokinetic Study|Correlative studies
15914024|NCT03542695|Procedure|Positron Emission Tomography|Undergo PET/CT
15914025|NCT03542682|Device|Quick Bolus|"Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via quick bolus of 15 units per minute during a euglycemic clamp."
15914026|NCT03542682|Device|Standard Bolus|"Individuals with Type 1 Diabetes (T1D) given 0.2 units/kg of rapid acting insulin (RAI) via standard bolus of 1.5 units per minute during a euglycemic clamp."
15914028|NCT03542656|Drug|amyloid PET|Dynamic PET acquisition for 60 minutes will be acquired after injection of 10 mCi 11C-PiB (39 frames: 8 x 15 seconds, 4 x 60 seconds, 27 x120 seconds).
15914029|NCT03542643|Dietary Supplement|n-3 Polyunsaturated fatty acid|1g of Eicosapentaenoic acid (EPA)
15914030|NCT03542643|Dietary Supplement|Placebo|Olive oil ethyl esters
15914031|NCT03542630|Diagnostic Test|salivary MMP8 test|All female participants will make salivary MMP8 test and certain blood parameters to determine systemic inflammatory response
15914032|NCT03542630|Other|periodontal examination|Periodontal examination by a specialist of periodontology will be made to all female participants, using periodontal probe and dental mirror.
15914036|NCT03542604|Behavioral|Cognitive Behavioral Therapy for Insomnia|CBT-I involves identifying and replacing thoughts and behaviors that cause or worsen sleep problems with habits that promote sound sleep. There will be 6 intervention sessions over an 8-week period. The first two sessions are consecutive weekly in-person sessions followed by a rest week. The third session is conducted remotely by phone, followed by another rest week. The three remaining sessions are weekly and conducted remotely.
15914037|NCT03542604|Behavioral|Sleep Education|EDU involves learning behavioral treatment information about sleep that is widely available to patients and practitioners. The program will parallel the CBT-I intervention in schedule, number, and length of sessions.
15914038|NCT03542591|Other|"Questionnaire on the topic Supplementation of critical nutrients in a plant-based diet"|No active intervention, only survey as mentioned above.
15914039|NCT03542578|Device|outpatient evaluation of fatty liver|outcome of ultrasound evaluation of liver in clinical outpatient settings
15914040|NCT03542552|Drug|Magnesium Sulfate|Patients received intravenous 6 g bolus MgSO4 20% followed by a 2 g/h infusion
15914041|NCT03542552|Drug|Nifedipine|received oral nifedipine 10 mg every 20 minutes for three doses, followed by 10 mg orally every 6 hours
15914042|NCT03542526|Device|electrogradiogram|12 lead ecg ambulatory blood prussre
15914043|NCT03542526|Device|ambulatory blood prussre|ambulatory blood pressure to measure blood pressure
15914044|NCT03542513|Device|Colli-Pee|Urine samples will be collected with the Colli-Pee device (Novosanis NV, Wijnegem, Belgium).
15914045|NCT03542513|Device|Qvintip|Vaginal self-samples will be collected with the Qvintip (Aprovix AB, Uppsala, Sweden).
15914046|NCT03542500|Behavioral|YRI+Entrepreneurship Training|"The Youth Readiness Intervention integrates six CBT-based, empirically-supported practice elements shown to have transdiagnostic efficacy across disorders ranging from major depressive disorder to PTSD and conduct disorders. The YRI's six evidence-based components are delivered in three phases common in trauma-informed interventions: stabilization, integration, and connection.
~The Entrepreneurship Training includes the following core components: financial literacy and entrepreneurship delivered through six modules (e.g.governance and conflict resolution, psychosocial competencies, entrepreneurship, employability). Our YRI curriculum will be used for the psychosocial competency training module.
~In this arm, youth will receive the YRI and then the Entrepreneurship Training"
15914047|NCT03542500|Behavioral|Entrepreneurship Training|The youth capacity development component of GIZ's Entrepreneurship Training includes the following core components: financial literacy, entrepreneurship, and vocational training delivered through six modules (agro-processing, solar photovoltaic installation and maintenance, governance and conflict resolution, psychosocial competencies, entrepreneurship, employability). Youth will be trained at training sites and have access to a youth center in the area. These centers will have agricultural equipment and machinery available for youth to use. Our YRI curriculum will be used for the psychosocial competency training module.
15914048|NCT03542487|Behavioral|Practice Orientation|Practices will be encouraged to batch order blood glucose flowsheets for all patients with diabetes with active MyChart accounts. This will allow diabetic patients at these practices to enter any self-monitored glucose measurements. The research team will contact physicians and practice managers with an explanation of the initiative and instructions for completing batch orders and viewing entries through the system. Additionally, providers will be given a template for a secure smart-text message to send to all patients receiving the flowsheets, instructing them to enter data for the study period. The secure message will also provide them with information on how to enter data, and on the benefits of tracking blood glucose.
15914049|NCT03542487|Behavioral|Standard Reminder|Patients receive generic biweekly reminders, addressed from Inova Medical Group, to enter glucose measurements in the electronic flowsheets
15914050|NCT03542487|Behavioral|Gift Card Reminder|Patients receive generic biweekly reminders, addressed from Inova Medical Group, to enter glucose measurements in the electronic flowsheets. In these reminders, they will also be notified that that they will be entered to win a $50 gift card for each day entering data.
15914051|NCT03542487|Behavioral|Physician Reminders|Patients receive biweekly reminders, addressed from their physician, encouraging them to enter glucose measurements in the electronic flowsheets (Note that though messages will be addressed from physician, they will be sent by Inova IT)
15914052|NCT03542474|Behavioral|High Intensity Endurance Exercise|Treadmill exercise at 80%-85% maximum heart rate for 30 minutes a day, 3 times per week, for 6 months.
15914053|NCT03542461|Drug|Nivolumab 10 MG/ML Intravenous Solution|240 mg as a 30 minutes IV infusion on Day 1 of each treatment cycle every 2 weeks, until intolerable toxicity or patient refusal or investigator's decision. In case of disease progression the treatment should be discontinued unless documented clinical benefits in the Investigator's judgement (no rapid progression, tolerance of trial drug, stable performance status, treatment maintenance does not delay an imminent intervention to prevent serious complication of PD) and no evidence of further progression at a radiographic assessment performed within 6 weeks. No dose escalations or reduction allowed. Administration delay until 6 weeks as well as resuming dose are allowed according to protocol defined criteria.
15914054|NCT03542461|Other|Best Supportive Care|Care that aims to optimize the comfort, function and social support of the patients and their family at all stages of the illness. Best Supportive Care (BSC)includes the use of analgesics, antibiotics, blood tranfusions, blood products, radiotherapy, corticosteroids, antiemetics, antidiarrheals, vitamins and any intervention aiming the improvement of patient's discomfort. Any chemotherapy, immunotherapy and targeted therapy are not considered as part of BSC.
15914055|NCT03542448|Device|Swept source optical coherence tomography|Measurement of choroidal thickness in myopic patients
15914056|NCT03542435|Drug|SXC-2023|Oral capsule
15914057|NCT03542435|Drug|Placebo|Placebo
15914058|NCT03542422|Drug|Apatinib|Metastasis after primary treatment : Apatinib + yew + platinum. Local recurrence after previous surgery/radiotherapy: Apatinib alone or in combination with platinum-based chemotherapy.
15914059|NCT03542409|Other|MR Perfusion Scan|MR perfusion scan before and during surgery.
15914060|NCT03542409|Other|2HG Spectroscopy Scan|2HG spectroscopy scan before and during surgery.
15914061|NCT03542396|Behavioral|ImPuls|Participants receive an supervised exercise intervention and behaviour change techniques for 4 weeks and, after that, they are encouraged to engage in physical activity for 8 weeks independently. During this 8-week individual phase, patients have weekly phone contacts with a psychotherapist
15945286|NCT03300609|Other|Quality-of-Life Assessment|Ancillary studies
15914063|NCT03542383|Device|Sham High Definition Transcranial Direct Current Stimulation|Administer sham HD tDCS over the preSMA for 20 minutes a session for 10 sessions over a two week period
15914064|NCT03542370|Other|DASH dietary pattern|A dietary pattern that emphasizes intake of fruits and vegetables, low-fat or non-fat dairy, limiting saturated fat intake, and usually also recommends limiting sodium intake.
15914065|NCT03542357|Drug|Calcitonin Gene Related Peptide|CGRP is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
15914066|NCT03542357|Drug|Sumatriptan 50 mg|CGRP is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
15914067|NCT03542357|Drug|Placebo Oral Tablet|CGRPis given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
15914068|NCT03542344|Drug|BI 1015550|Single rising oral dose
15914069|NCT03542344|Drug|Placebo|Single rising oral dose
15914070|NCT03542331|Drug|Lipiodol|Endometrial flushing with Lipiodol between day 6 and 8 of the cycle
15914071|NCT03542331|Device|Mock catheter|Introduction of a mock catheter in the uterus between day 6 and 8 of the cycle
15914072|NCT03542318|Other|Pulmonary Rehabilitation|A multidisciplinary PR programme was delivered twice weekly for 12 weeks. Each class was of 2 hours in duration. The first hour had an exercise component. Inspiratory muscle training was carried out using the Respironics IMT Threshold trainer® during the class. Educational sessions covered various aspects of pulmonary fibrosis care and self-management delivered. Patients also received an individualized home exercise programme consisting of exercise similar to what was being carried out during the classes. Each participant was encouraged to perform at least 20 minutes of these exercises per day.
15914073|NCT03542305|Drug|Lorlatinib|Lorlatinib single oral dose
15914074|NCT03542292|Diagnostic Test|placental drainage|
15914075|NCT03542279|Procedure|Plasma exchange|PE treatments are performed on an apheresis device (Fresenius MultiFiltrate hemodialysis filtration machine, German). PE volumes of 1 plasma volume per procedure will be used. Treatments will be given every other day with breaks allowed for weekends for most patients. The anticoagulant used is low molecular heparin. The use of high-dose glucocorticoid is 1,000 mg or 500 mg methylprednisolone for 3 or 5 days, and the dosage of glucocorticoid will gradually decrease.
15914076|NCT03542279|Drug|IVIG, High-dose glucocorticoid|IVIG is given 0.4 g/kg/d for each course for 5 days. The use of high-dose glucocorticoid is 1,000 mg or 500 mg methylprednisolone for 3 or 5 days, and the dosage of glucocorticoid will gradually decrease.
15914077|NCT03542266|Drug|CC-486 Administration|CC-486 at 300 mg once daily is to be administered Cycle 1, Day -6 to 0 and Cycles 1 to 5, Day 8 to 21. Antiemetic prophylaxis is recommended before dosing. All efforts should be made to administer CC-486 on all scheduled days of the Cycle 1 priming dosing (7 days, Cycle 1 Day -6 to Cycle 1 Day 0) and the Cycle 1-5 dosing (14 days, Day 8-21). A dose missed earlier in a day can be administered later that day as long as it is taken at least 8 hours before the next scheduled dose. Any missed dose should not be taken beyond the last scheduled day of CC-486 administration for the cycle, but should be returned by the subject for CC 486 accountability. If vomiting occurs after a dose of CC-486 is administrated, that dose should not be made up later that day.
15914078|NCT03542266|Drug|CHOP Administration|"CHOP is to be administered on Days 1 to 5 of Cycles 1-6. Chemotherapy can be administer within +72h or -24h of Day 1 of each scheduled Cycle. Preparation and infusion rate are according to the package insert and local practice. The doses to be used are:
~Cyclophosphamide: 750 mg/m2 IV on day 1 Doxorubicin: 50 mg/m2 IV on day 1 Vincristine: 1.4 mg/m2 IV (not to exceed 2.0 mg total) on day 1 Prednisone: 100 mg PO days 1-5"
15914079|NCT03542253|Procedure|Surgery|After surgical treatment, pathological specimens were extracted to obtain pathological results
15914080|NCT03542240|Dietary Supplement|Curcumin|500 milligram daily supplement
15914081|NCT03542227|Device|First-void urine collection|Collection of first-void urine (i.e. the initial stream of the urine void) with the Colli-PeeTM device (Novosanis).
15914082|NCT03542214|Combination Product|Calcium electroporation|Patients with inoperable colorectal cancer will be treated with calcium electroporation
15914083|NCT03542201|Other|PLS|Participants will have to read standard textual information about the conducted systematic review (approximately 500 words)
15914084|NCT03542201|Other|Blogshot|Participants will have to read the blogshot information about the results of the Cochrane systematic review (approximately 100 words)
15914089|NCT03542162|Biological|Healaflow|For the RRD patients, after 27G PPV, air-liquid exchange and endolaser photocoagulation around the tear(s), Healaflow is going to be fully covered on the surface of all retinal tears using 27G needle, the amount of Healaflow injection was determined according to the size of tears.
15914090|NCT03542149|Drug|OZ439 + α-tocopherol polyethylene glycol 1000 succinate|Artefenomel (OZ439), is a novel trioxolane Piperaquine is a bis 4-aminoquinoline and was used mainly in China from the 1960's to the 1980's as an antimalarial monotherapy.
15914091|NCT03542136|Device|VibrosSense Meter®|A multi frequency tactilometry device to evaluate the vibrotactile sense to indicate the underlying (Oxaliplatin induced poly neuropathy) OIPN and then compare the results with the results of CTCAE (Common toxicity criteria of adverse events) assessment tool evaluation.
15914092|NCT03542123|Device|NeuroTronik CANS Therapy® System|The NeuroTronik CANS Therapy® System is a percutaneous, catheter-based, bedside electrical stimulation system. The System consists of the single-use, disposable NeuroCatheter™ and NeuroCatheter™ Placement Kit, along with the reusable, bedside NeuroModulator™ Development System, and the NeuroTronik CANS Therapy™ Cable.
15915092|NCT03534297|Drug|Placebo capsules|Hard opaque capsules containing 0 mg of API.
15914095|NCT03542097|Other|MGMT methylation evaluation|The MGMT methylation will be evaluated by extracting DNA from fresh and Formalin Fixed paraffin Embedded (FFPE) tumor samples
15914096|NCT03542084|Other|Unsolicited endocrine e-consult|The PCP for intervention arm patients will receive an unsolicited e-consult from an endocrinologist with recommendations on how to improve glycemic control in the intervention patient
15914097|NCT03542071|Other|Carbohydrate restricted diet|The intervention is implemented by individual face-to-face counseling and mobile-phone counseling by a nutritionist, as well as food bags and recipes suitable for the diet. Targets: fruits and vegetables 500 g/d, fish 2 times/wk, low-fat instead of high-fat meat, red meat ≤ 3 times/wk, low-fat instead of high-fat dairy, high-fibre instead of low-fibre grains, vegetable oils (excluding palm oil and coconut oil) and soft margarine instead of animal fats, moderate reduction of carbohydrates (targets for macronutrients: carbohydrates 40 E%; fat 40 E%; protein 20 E%; dietary fiber 32g, energy intake approximately 2000 kcal/d; protein intake 20 E%; sucrose: <10 E%; fatty acids: saturated fatty acids < 10 E%, polyunsaturated fatty acids 5-10 E% and the rest of fat as monounsaturated fatty acids)
15914098|NCT03542071|Other|Plant-protein based diet|The intervention is implemented by individual face-to-face counseling and mobile-phone counseling by a nutritionist, as well as food bags and recipes suitable for the diet. Targets: fruits and vegetables 1 kg/d; fish 3/wk; high-fibre grains, mainly rye, oat and barley; plant protein instead of meat protein; low-fat fermented dairy instead of other dairy; rapeseed oil and rapeseed-based margarine instead of other fats; no carbohydrate restriction (targets for macronutrients: carbohydrates 55 E%; fat 25 E%; protein 20 E%; dietary fiber 36g, energy intake approximately 2000 kcal/d; protein intake 20 E%; sucrose: <10 E%; fatty acids: saturated fatty acids < 10 E%, polyunsaturated fatty acids 5-10 E% and the rest of fat as monounsaturated fatty acids)
15914099|NCT03542058|Drug|Carvedilol|Participants who are randomized to treatment group will receive carvedilol for a period of 6 month.
15914100|NCT03542045|Device|Cemented ATTUNE® Knee System|This product is for total knee arthroplasty. Four implant configurations are permitted: Cruciate Retaining Fixed Bearing (CR FB), Cruciate Retaining Rotating Platform (CR RP), Posterior Stabilizing Fixed Bearing (PS FB) and Posterior Stabilizing Rotating Platform (PS RP)
15914101|NCT03542032|Other|i-gel placement maneuvers|the i-gel was inserted with triple airway maneuver (mouth opening, head extension and jaw thrust) In the classic maneuver , the index finger used as a guide, pushes the back of i-gel towards the hard palate, inserting it into the pharynx till a resistance is felt and the i-gel is then fixed it its place.
15914102|NCT03542019|Device|Dental prosthesis|Replacement of missing tooth structure using Lithium disilicate porcelain
15914103|NCT03542019|Device|Dental crown|Replacement og missing tooth structure using monolithic zirconia
15914104|NCT03542019|Device|Hybrid ceramic|Restroration of endodontically treated teeth using hybrid ceramic
15914105|NCT03542006|Drug|Brinzolamide Ophthalmic|Topical brinzolamide given bd for 3 months
15914106|NCT03541993|Dietary Supplement|Resveratrol|
15914107|NCT03541993|Other|Placebo|
15914108|NCT03541980|Drug|Acetaminophen|Administration of 15 mg/kg (1000 mg max dose) of IV acetaminophen
15914109|NCT03541980|Drug|Normal saline|Normal saline volume equivalent
15914110|NCT03541967|Device|ADHEAR and PONTO 3 SUPER POWER on softband hearing aids|Device: ADHEAR non-implantable bone conduction hearing aid Comparator: PONTO 3 SUPER POWER bone conduction hearing aid with softband
15914111|NCT03541954|Other|Sensory testing of lower urinary tract.|Non invasive lower urinary tract sensitivity testing: provoked diuresis with sonographic estimates of sensory thresholds.
15914112|NCT03541954|Other|Sensory testing of lower rectal tract|Lower digestive tract sensitivity testing: rectal electronic barostat with ascending pressure (phasic distension).
15914113|NCT03541954|Other|Sensory testing of vulva muscles|Vulvar sensitivity testing: pressure pain threshold evaluated using vulvagesiometer.
15914114|NCT03541954|Other|Sensory testing of pelvic muscles|Myofascial sensitivity testing: piriformis, levator ani and obturator internus muscles pressure pain threshold evaluated using intra-vaginal algometer.
15914115|NCT03541941|Drug|Exparel|Solution of: 266mg of Bupivacaine Liposome Injectable Suspension (Exparel) mixed with 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block
15914116|NCT03541941|Drug|Bupivacaine Hcl 0.25% Inj|Solution of: 150mg of Bupivacaine Hydrochloride 0.25% expanded with 60cc of Normal Saline (Nacl0.9%) administered intraoperatively through a transversus abdominis plane (TAP) block
15914117|NCT03541941|Drug|Placebo|Normal saline administered intraoperatively through a transversus abdominis plane (TAP) block
15914118|NCT03541928|Drug|HSV-Tk|"Injection of the HSV-tk gene therapy product in four quadrants of prostate to enhance the immune system via bystander effect in which cytotoxicity is conferred to non-transduced neighboring cells. In vivo bystander effects are likely due to a combination of host immunological responses and to gap junction-mediated transport of phosphorylated prodrug metabolites to surrounding cells."
15914119|NCT03541928|Drug|Valacyclovir|The recommended dose for this trial is 2 g orally t.i.d. for 14 days (day 1 to day 15 and days 31 to 45). This dose has been calculated to give a similar AUC as 10 mg/kg of intravenous acyclovir administered every 8 hours. This is the same dose regimen used in a previous phase I clinical trial of ADV/HSV-tk plus acyclovir and topotecan in patients with recurrent ovarian cancer.
15914120|NCT03541928|Drug|Bicalutamide|"The recommended dose for Bicalutamide therapy in combination with an LHRH analogue is one 50 mg tablet once daily (morning or evening), with or without food. It is recommended that Bicalutamide be taken at the same time each day.
~The use of an oral antiandrogen with medical castration for the treatment of prostate cancer is referred to as combined androgen blockade (CAB). Compared with LHRH-agonist monotherapy, CAB with bicalutamide did not reduce overall QoL but provided an early improvement in QoL related to lower urinary tract symptoms and pain."
15914121|NCT03541928|Drug|Leuprolide Acetate|Leuprolide acetate 7.5 mg depot injection will be injected monthly for a total of 2 months.
15914122|NCT03541928|Radiation|Brachytherapy, External beam radiotherapy|On day 60, patient will undergo high dose rate (HDR) Brachytherapy. The patient will have 8-14 needle catheters inserted under ultrasound guidance. CT simulation and radiation treatment planning will be performed. The needle catheters will be connected to an HDR afterloader containing an Iridium 192 source. A single dose of 1250cGy will be delivered.
15914741|NCT03537222|Diagnostic Test|Myeloma Patient Outcome Scale (MyPOS)|Patients complete the MyPOS questionnaire on quality of life
15914123|NCT03541928|Procedure|Radical prostatectomy|approximately 2-3 weeks after radiotherapy completion, patient will undergo radical retropubic prostatectomy. Use of laparoscopy or robotic assistance will be at the urologist's discretion. Lymph node dissection will be performed.
15914124|NCT03541915|Drug|Mg (magnesium sulfate)|20mg/kg of magnesium sulfate will be infused after induction of anesthesia. And magnesium sulfated will be continuously infused at a rate of 15mg/kg/h during the operation.
15914125|NCT03541915|Drug|Control (saline)|The same volume of normal saline will be infused after induction of anesthesia and continuously infused at the same rate of magnesium.
15914126|NCT03541902|Drug|Cabozantinib|Given PO
15914127|NCT03541902|Drug|Sunitinib Malate|Given PO
15914128|NCT03541889|Drug|FLT imaging and TK1 blood measurements|F18 labeled thymidine PET/CT scans will be performed. Serum measurements of TK1 will be obtained.
15914129|NCT03541876|Other|Collection of data|"The following data will be collected by the physician :
~sociodemographic profile (age, sex, country of birth of child and parents); clinical manifestations; endoscopic aspects (esophagus, duodenum, stomach); different methods of diagnosis of infection; different primary and secondary bacterial resistance profiles ; different first and second line therapeutic combinations; different first and second line bacterial eradication rates ; different signs of side effects and tolerance of first and second line treatments; different methods of bacterial eradication control."
15914133|NCT03541837|Drug|Ropivacaine|ESP catheter
15914134|NCT03541824|Behavioral|Body Acceptance Program|The Body Acceptance Program is a mixed-gender modification of the eBody Project, an online intervention in which cognitive dissonance principals are used to reduce eating pathology.
15914135|NCT03541811|Diagnostic Test|3-d gait examination (level walking)|"Instrumented 3d-gait-analysis will be carried out in the movement lab of the FH (Fachhochschule; University of Applied Sciences) Campus Wien - University of Applied Sciences. The system used is a 10 camera T40S Vicon system with two floor-mounted AMTI OR6/7-2000 force plates. For assessing gait the Plug-in-Gait Lower Body Model with 14 mm retroreflective skin-mounted markers is implemented in the capturing software Vicon Nexus 2.2. The specific parameters will be extracted from the reporting software Vicon Polygon 4.2.
~Markers will be placed by one experienced examiner. Subjects will be instructed to walk barefoot on a 10 meters walkway at self-paced walking speed until five right and five left valid first force plate strikes are captured."
15914136|NCT03541811|Diagnostic Test|Anthropometrics and body composition assessment|Body height will be measured with the stadiometer Seca 213 to the next 0.1cm. Body size and weight will be measured without shoes and outerwear. A correction of 1 kg will be subtracted for clothing. Body weight and body composition will be assessed with the medical body composition analyzer Seca mBCA 515 based on bioelectric impedance analysis.
15914137|NCT03541811|Diagnostic Test|Biomarkers|"Blood will be collected into Vacuette serum-separating tubes and will be kept at room temperature for 30 min. Samples will be centrifuged at 1500g for 10 min and serum aliquots will be stored at 80 C until use. Urine samples will be collected into Vacuette tubes containing no additive from non-fasted individuals between 8:00 and 12:00 a.m. Urine samples will be kept at 4 °C for a maximum of 8 h, and then aliquoted and stored at 80 °C.
~All biomarkers (except vitamin D and CRP) will be measured in duplicates using standard enzyme-linked immunosorbent assay (ELISA) kits. Serum samples will be assessed for the level of sCOMP, sC1,2C, and sCS846, IL-6, IL-1, sTNFR1 and sTNFR2. Vitamin D and CRP will be measured using automated immunoassay. In urine samples uCTX-II will be determined and these levels will be corrected for creatinine levels (Jaffé method, in-house validated method)."
15914138|NCT03541811|Diagnostic Test|Clinical examination|Hemophilia joint health score (HJHS) will be assessed. Height will be measured with a stadiometer (SECA 213), weight with a medical scale (Marsden M-420) and leg length according to the Plug-in-Gait protocol with a measuring tape from the Anterior Spina Iliaca Superior to the distal aspect of the Medial Malleolus. Further anthropometrical parameters taken will be knee distance and malleoli distance by using a caliper. Gait relevant passive joint ROM of the knee, hip and ankle will be assessed by means of a handheld goniometer. The flexibility of hamstring muscles will be expressed as Popliteal Angle measured with a goniometer with the subjects supine and the hip in 90° flexion.
15914139|NCT03541811|Diagnostic Test|Habitual physical activity tracking (accelerometer based)|Participants will be instructed to wear an Actigraph wGT3X-BT tri-axial accelerometer permanently over a period of seven consecutive days with an elastic band on right hand sided hip. Data will be process with software ActiLife version 6.13. Cut-offs of at least 10 hours daily wear-time and a minimum of three valid weekdays and one valid weekend day will be applied for data cleaning. Count sampling epoch will be set at one minute. The so called Freedson Adult VM2 Cut-Offs will be applied to categorize physical activity intensities. The so called Freedson VM3 Combination will be applied for the estimation of activity energy expenditure.
15914140|NCT03541798|Procedure|positions of patients for combined spinal-epidural anesthesia|Patients in groups will be positioned according to the study groups for performing combined spinal epidural anesthesia.
15914141|NCT03541798|Procedure|Combined spinal epidural anesthesia|After positioning, a combined spinal epidural anesthesia (CSE) will be applied using a CSE Tuohy Needle (18 G) and 27 G Whitacre spinal needle via needle - through needle technique. The epidural space will be located with loss of resistance to saline. 3 ml hyperbaric bupivacaine 0.5% (15 mg) will be given for spinal anesthesia after identification of subarachnoidal space.
15914142|NCT03541772|Dietary Supplement|Oncoxin-Viusid®|Radiotherapy for 6-8 weeks, chemotherapy for 1-22-43 days during Radiotherapy and Oncoxin-Viusid® (75 ml/day) before/during/after both treatments
15914143|NCT03541772|Dietary Supplement|Placebo|Radiotherapy for 6-8 weeks, chemotherapy for 1-22-43 days during Radiotherapy and placebo (75ml/day) before/during/after both treatments
15914144|NCT03541759|Drug|Hydromorphone Hcl 4Mg Tab|Hydal retard 4Mg Tab 2 times after surgery as basic medication. Hydal retard 2.6Mg maximum 2 per 24h when NRS > 5.
15914145|NCT03541759|Drug|Piritramide 15mg s.c.|Dipidolor 15mg s.c. 2 times after surgery as basic medication. Dipidolor 7.5mg s.c. maximum 2 per 24h when NRS > 5.
15914213|NCT03541239|Device|Single Cuff Tourniquet 8000|If randomized to ischemic conditioning the cuff will be inflated as stated before. If randomized to non-ischemic conditioning the cuff will not be inflated.
15914146|NCT03541746|Biological|Platelet Rich Plasma|After hysteroscopic adhesiolysis, 30 patients will undergo once injection of 5ml PRP into the wall then lining the uterine cavity by 5ml platelet rich plasma gel. Finally, Foley balloon catheter will be inserted intrauterine then inflated and cutting its stem and to be left for two weeks.
15914147|NCT03541746|Device|Intrauterine Foley's Catheter|After hysteroscopic adhesiolysis, 30 patients will undergo intrauterine insertion of one inflated Foley balloon catheter with cutting its stem only to be left for two weeks.
15914148|NCT03541733|Other|mid-gut tubing|mid-gut tubing at different time
15914149|NCT03541720|Drug|18F-DA|18F-DA is an investigational PET radiotracer
15914150|NCT03541707|Device|Deep TMS Brainsway's H coil|"During the treatment trial period all subjects will receive the following dose of TMS: 18 Hz, at 100% RMT, 2 sec pulse train, 20 second inter-train interval, 80 trains, for a total of 57,600 pulses over the complete treatment course. In the placebo group a state of the art sham procedure will be used- the coil is programed to produce the noise and local sensation but with no activation.
~EEG Recording is done with and without an acoustic oddball trigger, in order to have both resting state and event related recordings. The evaluation takes approximately 5 minutes."
15914151|NCT03541694|Biological|Stamaril®|Routine vaccination with Stamaril yellow fever vaccine
15914152|NCT03541681|Procedure|Glucocorticoid Injections|1 ml Dexamethasone + 0,5 ml Bupivacain
15914153|NCT03541681|Procedure|Anesthetic Injections|0,5 ml Bupivacain
15914154|NCT03541668|Drug|Recombinant human urokinase|Patients receive rhPro-UK 35mg,15mg of which is given as a bolus within 3 minutes followed by dlivery of the remaining 20 mg as a constant infusion over a period of 30 minutes.
15914155|NCT03541668|Drug|Alteplase|Patients receive rt-PA in a dose of 0.9mg per kilogram of body weight(maximum,90 mg),10 percent of which was given as a blous followed by delivery of the remaining 90 percent as a constant infusion over a period of 60 minutes.
15914156|NCT03541655|Drug|Bupivacaine HCl|0.25% Bupivacaine HCl
15914157|NCT03541655|Drug|F14 (celecoxib)|Celecoxib in novel drug delivery system (BEPO™)
15914158|NCT03541642|Behavioral|Enhanced Intervention|Targeted PrEP counseling; targeted written/visual materials; follow up supportive text messages; distribution of PrEP at the syringe exchange
15914159|NCT03541642|Behavioral|Basic Intervention|General messaging from medical personnel; reminder text messages; distribution of PrEP at the syringe exchange
15914160|NCT03541616|Device|ECG Patch, pocket ECG monitor|Two consecutive 14-day ECG monitor patches or one single 28-day pocket ECG monitor (28-days total monitoring) implemented at the time of hospital discharge .
15914161|NCT03541603|Drug|Levosimendan|A sterile 2.5 mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion
15914162|NCT03541603|Drug|Matching Placebo|A sterile 2.5mg/mL concentrate solution that is diluted in 5% Dextrose or 0.9 Normal Saline to achieve a 50 microgram/min solution for infusion
15914163|NCT03541590|Procedure|Percutaneous transhepatic biliary drainage|When ERCPs failed or was not possible to be performed due to an altered anatomy in patients with malignant extrahepatic bile duct obstruction, PTBD was performed next in all patients. Percutaneous bile duct puncture was guided by Color Doppler ultrasound. The further procedure was guided by fluoroscopy. A self-expandable metal stent (SEMS) was inserted into the obstructed bile duct by endoscopic luminal guidance in the first session. After successful SEMS implantation, the percutaneous external catheter was removed at the end of the procedure.
15914164|NCT03541577|Device|TruePhysioTM Microcatheter|Provide hemodynamic information for the diagnosis and treatment of coronary and peripheral artery disease. The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve (FFR).
15914165|NCT03541577|Device|Pressure Wire|Provide hemodynamic information for the diagnosis and treatment of coronary and peripheral artery disease. The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve (FFR).
15914166|NCT03541564|Drug|BMS-986165|Specified dose on specified days
15914167|NCT03541564|Drug|Moxifloxacin|Specified dose on specified days
15914168|NCT03541564|Other|Placebo|Specified dose on specified days
15914169|NCT03541551|Procedure|CTT with ologen® Collagen Matrix|ologen® Collagen Matrix approved by Indian health authority with registration numberof MD-1517 will be provided by Aeon Ajanta India Pvt. Ltd. free of cost for this clinical research only.
15914170|NCT03541551|Procedure|Trab Trab|combined trabeculotomy with trabeculectomy
15914171|NCT03541538|Device|Global manipulation|The therapist positioned himself at the head of the stretcher and with one hand supported the side of the participant's face. With the other hand supported the opposite face of the same and then performed contralateral rotation of the cervical and a slight traction to the tissue barrier to perform the manipulation impulse of high speed and short amplitude in rotation. The procedure was carried out bilaterally.
15914172|NCT03541538|Device|Especific manipulation|The therapist positioned himself at the head of the stretcher and with one hand kept the middle phalange of the second finger laterally on the articular processes of the C6-7 vertebrae. With the contralateral hand he supported the opposing face of the participant by performing a tilt up to the C6-7 segment and contralateral rotation up to the tissue barrier to carry out the impulse quickly and short. The procedure was carried out bilaterally.
15914173|NCT03541525|Other|Biological sampling|Biological samples including blood, surgical remainder, urine,...
15914174|NCT03541512|Behavioral|Mindfulness + Education|"Women in the mindfulness + education group will be asked to meditate daily, 10 minutes a day for the first 4 weeks with the option to increase their time to 20 minutes daily during the second 4 weeks. Women will also receive educational materials each week addressing different themes such as; Introduction and Overview, The Vulva, Provoked Localized Vulvodynia (PLV), Treatment of PVL, The Pelvic Floor, Sexuality, Chronic Pain, and Promoting Sexual Health."
15914175|NCT03541512|Behavioral|Education|"Women will also receive educational materials each week addressing different themes such as; Introduction and Overview, The Vulva, Provoked Localized Vulvodynia (PLV), Treatment of PVL, The Pelvic Floor, Sexuality, Chronic Pain, and Promoting Sexual Health."
15914176|NCT03541499|Biological|BPZE1|Lyophilized, live-attenuated Bordetella pertussis vaccine reconstituted with sterile water for injection (SWFI) and administered as a single intranasal dose of either 10^7 colony forming units (CFU) or 10^9 CFU.
15914177|NCT03541499|Other|Placebo|The placebo consists of the same constituents in the same quantities as the BPZE1 investigational vaccines, absent the attenuated B. pertussis cells, reconstituted with sterile water for injection (SWFI).
15914178|NCT03541486|Drug|Ascorbate|75 gram infusion daily (M-F) on days when radiation therapy is administered
15914179|NCT03541486|Drug|Gemcitabine|600 mg/m2 once weekly for 6 weeks
15914180|NCT03541486|Radiation|radiation therapy|Prescribed to either 50 Gy in 25 fractions or at least 50.4 Gy in 28 fractions, based on tumor. Radiation is delivered 1 fraction/day, 5 days a week, for approximately 5 to 6 weeks.
15914181|NCT03541473|Dietary Supplement|Peptamen® 1.5 Vanilla|Nutritionally complete formula with 10g MCT in 250 mL, commercially available
15914182|NCT03541473|Dietary Supplement|Boost Plus® Vanilla|Product of same nutritional composition but without MCT
15914183|NCT03541447|Drug|Tolvaptan|Starting morning and afternoon doses of 45 and 15 mg, respectively, to be up titrated every two days to 60 and 30 mg and then to 90 and 30 mg, according to tolerability.
15914184|NCT03541447|Drug|Octreotide LAR|A single dose of two 20 mg i.m. injections.
15914185|NCT03541447|Other|Placebo|A single dose of two 20 mg i.m. injections.
15914186|NCT03541434|Diagnostic Test|Complete Blood Count|White blood cell subgroups count
15914187|NCT03541434|Diagnostic Test|Tympanometry|Conventional and multifrequency tympanometry, documenting middle ear admittance and absorbance
15914188|NCT03541434|Procedure|Tonsillectomy and/or adenoidectomy|Excision of palatine and/or pharyngeal tonsils.
15914189|NCT03541421|Other|Patient involvement in administration of drugs|The patient´s own drugs and an updated medication list will be placed in a lockable bedside table. During hospitalization the patient is responsible for taking his own medication. If a new drug is prescribed, the patient will be involved and instructed about it. Furthermore the smallest package will be delivered so that the patient can begin self-administration of the new drug during hospitalization.
15914190|NCT03541408|Other|Control|Standard Of Care without Preventative Delirium Protocol
15914191|NCT03541408|Other|Preventative Delirium Protocol|Preventative Delirium Protocol
15914192|NCT03541395|Drug|GnRH antagonist|
15914193|NCT03541382|Device|OraQuick® HIV Self-Test|"Community leaders, including GVHs, Village Health Committee members, Village Development Committee members, and members of key community groups will participate in a workshop to facilitate planning of a HIVST campaign. Identified community distributors, who are unpaid volunteers from the community, will also receive a training package in HIVST promotion.
~Campaigns will be conducted over a short period (approximately seven days) and under a fixed budget. Community distributors will deliver HIVST kits free of charge to community members, and provide information on how to self-test and access the nearest clinic for linkage to confirmatory HTS, treatment and prevention. Distributors will also provide HIV prevention messages around serodiscordancy, treatment as prevention and VMMC."
15914194|NCT03541369|Drug|AMG 427|AMG 427 will be administered as an intravenous (IV) infusion in adult subjects with relapsed/refractory AML.
15914195|NCT03541356|Combination Product|Placebo|Delivered via the I231 POD (Precision Olfactory Delivery) device
15914196|NCT03541356|Combination Product|L-dopa 35 mg|Delivered via the I231 POD (Precision Olfactory Delivery) device via one puff to one nostril
15914197|NCT03541356|Combination Product|L-dopa 70mg|Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
15914198|NCT03541356|Combination Product|L-dopa 140 mg|Delivered via the I231 POD (Precision Olfactory Delivery) device with four puffs, two to each nostril
15914199|NCT03541356|Combination Product|L-dopa 70mg/carbidopa 7mg|Delivered via the I231 POD (Precision Olfactory Delivery) device with two puffs, one to each nostril
15914200|NCT03541343|Device|GreenBone implant|Patients will receive the GreenBone implant instead of bovine xenograft for iliac crest reconstruction following autologous bone graft harvesting.
15914201|NCT03541330|Other|semi-directive interview|semi-structured interview conducted by a clinical psychologist
15914202|NCT03541317|Behavioral|Stage 1 Strategy: REP|Schools will receive a daylong didactic training covering core elements of CBT and proper screening and identification of students; training to help SPs identify eligible students; a package that includes tools to deploy CBT; and ongoing technical assistance in CBT implementation.
15914203|NCT03541317|Behavioral|Stage 1 Strategy: REP + Coaching|"Schools will receive a daylong didactic training covering core elements of CBT and proper screening and identification of students; training to help SPs identify eligible students; a package that includes tools to deploy CBT; ongoing technical assistance in CBT implementation; and weekly visits from a CBT expert or Coach, for a minimum of 12 weeks."
15914204|NCT03541317|Behavioral|Stage 2 Strategy: Augment with Facilitation|In addition to first-line treatment (REP or REP + Coaching), schools will also receive support from a Facilitator who is a member of the study team and has expertise in CBT, implementation methods, and use of EBPs in schools will support SPs in strategic thinking and leadership skills to address organizational barriers.
15914205|NCT03541317|Behavioral|Stage 2 Strategy: No augmentation|Schools will continue to receive their first-line treatment (REP or REP + Coaching); no additional support will be offered.
15914206|NCT03541291|Device|SMART-SYNC LM03|Doppler ultrasound cardiac gating device for fetal MRI application
15914207|NCT03541278|Procedure|MIT|periareolar intraparenchymal, high volume and ultrasonographic guidance
15914208|NCT03541278|Procedure|IM-SLNB|IM-SLNB was performed for IMLN visualized patients
15914209|NCT03541265|Drug|Exparel|long-acting Bupivacaine extended release liposome compound
15914210|NCT03541265|Procedure|Adductor block protocol|Adductor block using Exparel
15914211|NCT03541265|Procedure|peri-articular injection protocol|peri-articular injection using Exparel
15914212|NCT03541252|Drug|AFL-assisted cisplatin+5-FU|Patients will receive AFL-assisted cisplatin+5-FU as a treatment for their BCC. In brief, treatment areas consisting of tumors and a 5 mm margin will undergo CO2 laser exposure followed by 60 min topical application of a marketed and commercially available IV cisplatin solution (0.1%) After removal of cisplatin, a commercially distributed 5-FU cream (5%) will be applied to the treatment area at a dose of 0.125 ml per cm2 and left under occlusion. After skin evaluations on Day 1 and 5 after treatment, the same 5-FU dose will be applied, again left under occlusion. In total, 5-FU will remain on the skin for 7 days after AFL treatment whereafter it will be washed off. An additional repeat AFL-cisplatin+5-FU treatment on Day 30 will be offered if tumors persist, based on clinical evaluation and imaging on Day 30.
15914214|NCT03541213|Procedure|myocardial biopsy|Myocardial biopsy (after opening cardiac cavities under general anesthesia for valvular surgery) for mitochondrial metabolism analyses.
15914215|NCT03541213|Procedure|sternal bone marrow biopsy|Sternal bone marrow biopsy (after sternal opening under general anesthesia for valvular surgery) for the quantification of iron stores
15914216|NCT03541213|Biological|blood sample|blood sample (under general anesthesia for valvular surgery, using the arterial catheter already in place) for hepcidin quantification (hormone not dosed in the usual martial assessment)
15914217|NCT03541200|Drug|MT-8554|MT-8554 Oral
15914218|NCT03541187|Biological|German cockroach allergenic extract|Active ingredient: a non-standardized allergen derived from the extraction and purification of proteins from German cockroach (Blattella germanica). Non-standardized glycerinated German cockroach allergenic extract is approved in the United States for diagnostic skin testing and immunotherapy by subcutaneous injection (U.S. License 467).
15914219|NCT03541187|Biological|Placebo for German cockroach allergenic extract|Commercially- labeled licensed product, sterile diluent for allergenic extract (50% glycerinated), sodium bicarbonate (0.091%) sodium chloride (0.166%).
15914223|NCT03541148|Dietary Supplement|Oncoxin-Viusid|Oncoxin-Viusid supplement before/during/after standard surgical and adjuvant treatment or chemotherapy.
15914224|NCT03541122|Diagnostic Test|pelvic X-ray examinations|Measurement indicators will include OFI, MUI, TBOI, CE angle, Sharp angle and AHI of the affected and healthy femoral heads.
15914225|NCT03541109|Drug|Polypill|fixed dose combination of aspirin (81mg), atorvastatin (40mg), metoprolol (50 mg), and Valsartan (40 mg)
15914226|NCT03541096|Behavioral|Winter Swimming|Supervised Winter Swimming in Copenhagen
15914227|NCT03541096|Behavioral|Control group|No winter swimming activities.
15914228|NCT03541083|Drug|Blinatumomab|prephase and consolidation (I and II)
15914229|NCT03541070|Device|Kinesiology tape|Kinesiology taping (KT) was developed by Kenzo Kase in the 1970s. KT has similar thickness and flexibility to the skin. These tapes are used in orthopedic and sports injuries as well as neurological and rheumatic diseases, pediatric patients, lymph edema and painful conditions. These tapes are used for correcting muscle function, increasing circulation, increasing proprioception, reducing pain, and repositioning the sublease joint according to the usage method
15914230|NCT03541044|Drug|Nicotine Prototype Mini lozenge|A single dose of a prototype nicotine 2mg lozenge will be placed in participants mouth, occasionally moving it side to side. Allowing it to slowly dissolve and try to minimize swallowing. Participants will be instructed not to chew lozenge. The lozenge should be completely dissolved.
15914231|NCT03541044|Drug|Nicorette Mini Lozenge|A single dose of a 2 mg nicotine polacrilex mini lozenge (Nicorette Minis) will be placed in participants mouth, occasionally moving it side to side. Allowing it to slowly dissolve and try to minimize swallowing. Participants will be instructed not to chew lozenge. The lozenge should be completely dissolved.
15914232|NCT03541031|Dietary Supplement|Micronutrient & Fish oil|Capsule containing a 36-ingredient micronutrient formula (EMPowerplus™) which has been widely researched for its usefulness in several psychiatric conditions. The second product is a capsule containing Fish oil (Wiley's Finest™ Wild Alaskan Fish Oil Peak EPA; 700 mg EPA plus DHA per capsule).
15914233|NCT03541031|Dietary Supplement|Olive oil & Safflower oil|Olive oil capsule manufactured to mimic Micronutrient and safflower oil capsule manufactured to mimic Fish oil
15914234|NCT03541018|Procedure|Type of repositional maneuvre|Patients randomized to 2 different repositional maneuvres related to the subtypes of BPPV
15914237|NCT03540979|Procedure|endometrial preparation for frozen blastocyst transfer|medical endometrial preparation for frozen blastocyte transfer
15914238|NCT03540979|Drug|Letrozole|Aromatase inhibitor - 2.5mg/d for 5 days
15914239|NCT03540979|Drug|Ovidrel|recommbinant hCG 250 mcg- single sc injection to induce ovulation
15914240|NCT03540979|Drug|Estrofem|Estrofem 2mg*3/d for endometrial preparation
15914241|NCT03540979|Drug|Endometrin 100Mg Vaginal Insert|vaginal tab for lutheal support
15914242|NCT03540966|Combination Product|CapulinTM|a kind of camouflage agent
15914243|NCT03540966|Other|Chinese version of the vitiligo life quality index, VLQI-C|a questionaire designed for patients with vitiligo
15914244|NCT03540953|Drug|Endoscopic injection of Mitomycin C|administration included dilation of the stenotic segment with thermoplastic bougies, followed by the injection of 3mg of Mitomycin C, divided into 4 aliquots of 0.75mg, injected in the four quadrants, at the stenosis level.
15914245|NCT03540940|Other|PEEP|7cmH2O positive end expiratory pressure
15914246|NCT03540940|Other|ZEEP|0 cmH2O positive end expiratory pressure
15914247|NCT03540927|Behavioral|PM+ for entrepreneurs|The intervention arm will receive 5 weekly face-to-face group sessions of Problem Management Plus(PM+ for entrepreneurs). Duration of each session is 2 hours. Session 1 orients participants to the intervention with motivational interviewing techniques to improve engagement,provides information about common reactions to adversity, and trains participants in a basic stress management strategy (slow breathing). Session 2 addresses a participant-selected problem using problem-solving techniques. Sessions 3 and 4 support participants' continued application of problem solving, behavioral activation, and stress management and introduce strategies to strengthen social support networks. In session 5, education about retaining intervention gains and self-care are provided and all learned strategies are reviewed.
15914248|NCT03540927|Other|Cash transfer to the Entrepreneurs|The entrepreneurs in the control arm will receive cash transfer only for their businesses.
15914249|NCT03540914|Drug|ACETAZOLAMIDE oral capsule|Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m
15914250|NCT03540914|Drug|Placebo oral capsule|Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m
15914383|NCT03539848|Device|I-PAS Goggles|Portable, head-mounted display goggle system with integrated eye capture technology
15914251|NCT03540901|Drug|ACETAZOLAMIDE oral capsule|Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3100m
15914252|NCT03540901|Drug|Placebo oral capsule|Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3100m
15914253|NCT03540888|Other|Deep transverse Friction Massage|The procedure consisted of applying friction massage by fingertips transversely to the hamstrings tendon, in a sitting position. The tendon was located over four finger widths proximal to the medial and lateral epicondyles of the femur
15914254|NCT03540888|Other|Dynamic stretching intervention|Participants in this group, swung their tested leg actively into hip flexion while keeping their knee fully extended and their ankle fully plantar flexed until a stretch was felt in the posterior thigh. This was repeated over 30 seconds and included in the participant's warm-up phase.
15914255|NCT03540888|Other|Static stretching intervention|In the static stretching intervention, all participants laid on the floor in a supine position with both feet pointing upwards, with the tested limb in full knee extension and the foot in a relaxed position. The tested limb was moved up passively to a point of slight pain or discomfort at the posterior aspect of the thigh. This technique puts the hamstrings muscle at its greatest possible length. This position should be held for 30 seconds and was performed three times for a total of one minute and 30 seconds, 15 minutes after a match or training. The contralateral leg was stabilized by means of another collaborator in order to prevent compensation by rotation or elevation of the pelvis.
15914256|NCT03540875|Device|Closed loop anesthesia|"Propofol and Remifentanil are administered automatically using a closed-loop system.
~The goal of this study is to compare manual titration versus automated titration of propofol and remifentanil in adult patients undergoing surgery guided by the electro-cortical activity. The aim in both group is to maintain the qCon in the range 40-60 during induction and maintenance of general anesthesia using the propofol in TCI mode. But also the qNox in the range 40-60 using remifentanil. The controller is based on a Proportional-Integral-derivative algorithm which steers a target to the pumps during induction and maintenance of general anesthesia."
15914257|NCT03540875|Drug|Propofol|The dosage is modified automatically by the device or according to the new medical prescription.
15914258|NCT03540875|Drug|Remifentanil|The dosage is modified automatically by the device or according to the new medical prescription.
15914259|NCT03540862|Device|maintenance negative pressure ventilation (Philips Respironics Lifecare NEV-100)|hospital-based NPV once every week as the maintenance program
15914260|NCT03540849|Drug|Brentuximab Vedotin (Bv)|HL patients who are eligible for the study, will receive maintenance Bv. The first Bv dosage will be administered three months after allo-SCT (day 90) at the dosage of 1.8 mg/kg every 21 days for 12 cycles. post allo-SCT maintenance Bv for Hodgkin lymphoma
15914261|NCT03540836|Drug|Relacorilant (3x100 mg softgel capsules)|A single relacorilant 300mg dose (3x100 mg softgel capsules) will be given once on Day 1 of one of three treatment periods.
15914262|NCT03540836|Drug|Relacorilant (3x100 mg hard-shell capsules)|A single relacorilant 300mg dose (3x100 mg hard-shell capsules) will be given once on Day 1 of one of three treatment periods.
15914263|NCT03540836|Drug|Relacorilant (6x50mg hard-shell capsules)|A single relacorilant 300mg dose (6x50mg hard-shell capsules) will be given once on Day 1 of one of three treatment periods.
15914264|NCT03540823|Biological|Inactivated and fragmented influenza vaccine (A / Michigan / 45/2015 (H1N1) pdm09-like virus, A / Singapore / INFIMH-16-0019 / 2016 (H3N2) -like virus; B / Phuket / 3073/2013-like virus)|Single dose of Inactivated and fragmented influenza vaccine (A / Michigan / 45/2015 (H1N1) pdm09-like virus, A / Singapore / INFIMH-16-0019 / 2016 (H3N2) -like virus; B / Phuket / 3073/2013-like virus)
15914265|NCT03540810|Drug|Hydroxychloroquine|The patients will additionally receive this drug with their usual treatment to evaluate its efficiency to prevent new thrombotic events in primary antiphospholipid syndrome patients
15914266|NCT03540810|Drug|Placebo|The patients will receive placebo with their usual treatment
15914267|NCT03540784|Other|WB-EMS|WB-EMS training is performed 2x/week for 12 weeks; Stimulation protocol: Frequency of 85 Hz, pulse duration of 0.35 ms, stimulation period of 6 sec, resting period of 4 sec; supervised by certified training instructors/physiotherapists participants perform simple exercises during the stimulation period following a video tutorial
15914268|NCT03540784|Other|Nutritional support|dietary monitoring by dietary records; nutritional counselling by dietician, dietary advices: 1.5 g/kg bodyweight/day
15914269|NCT03540771|Other|Palliative Care|"The intervention will comprise an approach to render palliative care, as taught to hepatologists through an on-line learning platform, and as delivered by PC providers as routine care. The elements of the intervention, which will be guided by a checklist and implemented over the course of interactions with the patient and caregivers at the initial, 1, 2, and 3 month visits, to include:
~Patient/caregiver understanding of diagnosis, illness and prognosis
~Symptom assessment and management
~Psychosocial assessment and management
~Distress screening and management
~Discussion of goals of care
~Advanced directives"
15914273|NCT03540745|Device|TES Treatment|Device: Nexalin Based Trans-Cranial Electrical Stimulation The Nexalin device, FDA clearance (501K=K024377, Classification: Stimulator, Cranial Electrotherapy: CFR 882. 5800: U.S. Patent #6904322B2), produces a square waveform that provides trans-cranial electrical stimulation to the brain delivered at a frequency of 77.5 Hz at 0 to 4 mA peak current. Other Name: TES
15914274|NCT03540745|Device|TES-SHAM Treatment|Device: Nexalin Based Trans-Cranial Electrical Stimulation The Nexalin device, FDA clearance (501K=K024377, Classification: Stimulator, Cranial Electrotherapy: CFR 882. 5800: U.S. Patent #6904322B2), produces a square waveform that provides trans-cranial electrical stimulation to the brain delivered at a frequency of 77.5 Hz at 0 to 4 mA peak current. Other Name: TES
15914277|NCT03540719|Procedure|Osteosynthesis|Osteosynthesis of posterior tibial plateau fracture with a posterior tibial plateau plate
15914278|NCT03540706|Diagnostic Test|Care with C-reactive protein assay in micro method|Care with C-reactive protein assay in micro method
15914279|NCT03540693|Procedure|RYGB|RYGB-weight loss surgery
15914280|NCT03540693|Procedure|SG|SG- weight loss surgery
15914281|NCT03540693|Procedure|LAGB|LAGB- weight loss surgery
15914282|NCT03540680|Other|Blood punction|"For the arms Term newborns (≥37GA) and Premature newborns the only intervention is a blood punction on the cordon.
~For the arms Child between 7 and 15 years old with or without BPD the only intervention is a blood punction on peripheral blood."
15914283|NCT03540654|Other|Budget impact|Budget impact, using a probabilistic markov model, of discontinuing TKI treatment in patients with CML in deep molecular response since at least two years, compared with current practice (treatment during entire life), from the healthcare system point of view
15914284|NCT03540641|Device|MagVenture MagPro R30|the subjects will receive 1500 or 5000 pulses at 5Hz
15914285|NCT03540628|Dietary Supplement|Thiamine and Vitamin C|Supplementary vitamins for the patient in septic shock
15914286|NCT03540615|Drug|BAY1830839|Dose escalation in healthy male subjects
15914287|NCT03540615|Drug|Placebo|Matching placebo
15914288|NCT03540602|Dietary Supplement|Tart Cherry|NordicCherry Tart Cherry Extract Powder 500 mg from Specnova, inc
15914289|NCT03540602|Other|Placebo Oral Capsule [CEBOCAP]|Rice flour
15914290|NCT03540589|Device|Buzzy specific vibration device|It is a device that produces vibration
15914291|NCT03540589|Behavioral|Distraction|The distraction will be obtained through tablet with videos
15914292|NCT03540563|Other|Blood draw|Blood will be drawn to assess ctDNA
15914293|NCT03540550|Other|Diet based on inulin-rich vegetables|During two weeks, healthy subjects were instructed to adhere to a controlled diet based on ITF-rich vegetables (±15 g ITF/day).
15914294|NCT03540537|Other|Patient-controlled intravenous analgesia|PCIA solution: 2 μg/kg weight sufentanil and 8.96 mg tropisetron mesylate diluted in 100 ml normal saline；PCIA parameters: loading dose: 2 ml, background infusion: 2ml/h, bolus: 0.5ml, lockout-time: 15min; PCA duration: 48 hours from the end of suturing
15914295|NCT03540537|Other|Quadratus Lumborum Block|Ultrasound-guided Quadratus lumborum block: A broadband (5-8 MHz) convex transducer will be placed transversely in the abdominal flank above the iliac crest to identify the external oblique, internal oblique, transversus abdominis muscles and aponeurosis. Then the external oblique muscle will be followed posteriorly until its posterior border is visualized (hook sign), and the posterior aspect of the Quadratus lumborum muscle is confirmed. A 22-G, 11-mm, short-bevel facet needle will be advanced under direct ultrasound visualization in-plane from anterolateral to postero-medial. Then the 20 ml of 0.375 % ropivacaine will be injected into the lumbar inter-facial triangle (LIFT) behind the quadratus lumborum muscle using hydro-dissection.
15914296|NCT03540537|Other|Thoracic Paravertebral Block|Ultrasound-guided Thoracic paravertebral block: The patient is placed in the lateral position, the spinous processes of T6 and T8 are identified and marks are made 2cm lateral to the spinous processes. The linear(L12-3) probe is placed transversally at the mark to identify the paravertebral space. Then a 22-G needle is inserted in-plane from lateral to medial and advanced until the tip reached the paravertebral space surrounded by the parietal pleura and the superior costotransverse ligament. Then 15 ml 0.375% ropivacaine is injected into the paravertebral space of T6 and T8.
15914297|NCT03540524|Drug|GLPG2451 dose regimen A|GLPG2451 oral suspension, daily.
15914298|NCT03540524|Drug|GLPG2451 dose regimen B|GLPG2451 oral suspension, daily.
15914299|NCT03540524|Drug|GLPG2222|GLPG2222 tablet for oral use, daily.
15914300|NCT03540524|Drug|GLPG2737|GLPG2737 capsules for oral use, daily.
15914301|NCT03540511|Diagnostic Test|postoperative troponin|assess postoperative troponin levels after cardiac surgery in patients with renal dysfunction
15914302|NCT03540498|Dietary Supplement|AB-DENTALAC [Probiotics (study)]|Treatment for 6 weeks, which will consist of the consumption of a chewing gum AB-DENTALAC with 100mg L.plantarum + L.brevis Probiotics blend (5E+8 CFU each at the end of shelf life), b.i.d (morning and evening).
15914303|NCT03540498|Dietary Supplement|Placebo (control)|Treatment for 6 weeks, which will consist of the consumption of a chewing gum placebo, without probiotics strains, b.i.d (morning and evening).
15914304|NCT03540485|Drug|Melatonin|Daily administration of 300 mg of melatonin orally, for 24 months, single dose of melatonin between 10pm to 11pm
15914305|NCT03540485|Other|Placebo|Daily administration of placebo orally, for 24 months between 10pm to 11pm
15914306|NCT03540472|Drug|tacrolimus|On refractory PRCA patients, tacrolimus was tried. Dosage: 1mg bid and tacrolimus trough targets were 5-10 ng/ml throughout the study
15914307|NCT03540459|Diagnostic Test|sleep polygraphy|sleep polygraphy (one night) in all included patients
15914308|NCT03540446|Device|First Relief Treatment|To prove the effectiveness of Percutaneous Electrical Neuro-stimulation therapy for the treatment of conditions associated with peripheral neuropathy, in a double-blind environment.
15914309|NCT03540420|Drug|Atezolizumab|atezolizumab 1200 mg intravenous every 3 weeks in 12 months
15914310|NCT03540407|Dietary Supplement|Oncoxin-Viusid®|Administration of the Oncoxin-Viusid® oral solution 25 mL three times a day during the concurrent Radiotherapy and Chemotherapy treatment and up to 3 weeks after the end of the onco-specific treatment
15914311|NCT03540407|Dietary Supplement|Placebo|Administration of the Oncoxin-Viusid® oral solution placebo 25 ml three times a day during the concurrent Radiotherapy and Chemotherapy treatment and up to 3 weeks after the end of the onco-specific treatment
15914312|NCT03540381|Other|neoatherosclerosis|
15914313|NCT03540368|Drug|Tranexamic acid injection|Administering tranexamic acid loading dose 1 gram in 100 cc sodium chloride 0,9%, followed by maintenance dose 3 grams in infusion for 24 hours.
15914314|NCT03540368|Other|Placebo|Administering placebo or sodium chloride 0,9% intravenously
15914315|NCT03540355|Drug|Cipros 20 association|oral, once a day
15914316|NCT03540355|Drug|Crestor 20 mg|Oral, once a day
15914317|NCT03540342|Procedure|One stop strategy group|Percutaneous coronary intervention (PCI) will be performed on the same operating table immediately after the endovascular aortic repair (EVAR)
15914318|NCT03540329|Device|Internal Osteogenesis distractor|Internal distraction osteogenesis in mandible
15914319|NCT03540329|Device|External Osteogenesis distractor|External distraction osteogenesis in mandible
15914320|NCT03540316|Combination Product|Two short implants and 2 minutes LLLT|Patients with edentulous atrophied mandibular ridge will receive 2 short dental implants and LLLT for 2 minutes.
15914321|NCT03540316|Combination Product|Two short implants and 4 minutes LLLT|Patients with edentulous atrophied mandibular ridge will receive 2 short dental implants and LLLT for 4 minutes.
15914322|NCT03540316|Combination Product|Four short implants and 2 minutes LLLT|Patients with edentulous atrophied mandibular ridge will receive 4 short dental implants and LLLT for 2 minutes.
15914323|NCT03540316|Combination Product|Four short implants and 4 minutes LLLT|Patients with edentulous atrophied mandibular ridge will receive 4 short dental implants and LLLT for 4 minutes.
15914324|NCT03540303|Drug|CAR19 T cells carrying cytoplasmic activated PD-1|"step 1: Collect 50-100ml of peripheral blood for culture of CAR19 T cells carrying cytoplasmic activated PD-1 step 2. After 72 hours, pretreated with FC regimen, details as follow Cyclophosphamide 600-800mg/m2 for 2 days Fludarabine 25-30mg/m2 for 3 days step 3: After another 48 hours transfusion the cells back to the patients the numbers of infused CAR T cells are 2x106 /kg for the first 3 patients, 6x106 /kg for the second 3 patients and 18x106 /kg for the third 3 patients.
~After finishing this, another 6 patients will be enrolled for observation of efficacy."
15914325|NCT03540290|Procedure|Modification of the implant supported prostheses in order to facilitate oral hygiene|Peri-implant mucositis will be treated by individualized oral hygiene instructions and decontamination of the implant surface by ultrasonic device with a plastic tip and plastic curettes plus the modification of the implant prosthesis in order to facilitate oral hygiene access
15914326|NCT03540277|Behavioral|"Experimental: Prevention Program young In Favor of Myself, active parents"|"Prevention program: young In Favor of Myself, with parent participation"
15914327|NCT03540277|Behavioral|"Experimental: Prevention Program young In Favor of Myself, no parental involvement"|"Prevention program: young In Favor of Myself, without parent participation"
15914328|NCT03540264|Device|Clearfil Majesty TM|Tooth wear - composite resin
15914329|NCT03540264|Device|Vita-Enamic®|Tooth wear - polymer-infiltrated-ceramic-network
15914330|NCT03540251|Other|Auricular Points Sticking|"Auricular Points Sticking is a kind of acupunture based on Meridians Theory of traditional Chinese Medicine.Sticking and pressing predefined therapeutic auricular points can relieve the frequency and severity of hot flashes and other climacteric symptoms.
~Both groups received a booklet with information about self-care indications, auricular points and its management, and patients can record their hot flash score each day for 12 weeks in the booklets.In addition, both group received 8 treatment sessions of sticking and pressing predefined auricular points or placebo auricular points treatments."
15914331|NCT03540225|Drug|Progesterone|Utrogestan Vaginal 200 mg or 400 mg daily from 11-14 Week or 20-24 Week until 34 Week
15914332|NCT03540212|Drug|Daclatasvir and sofosbuvir|"Daclatasvir is a DAAs that can inhibit the HCV non-structural (NS) 5A protein when used in combination with other HCV-therapies. It has a linear, non-time-dependent pharmacokinetic profile and nanomolar potency in vitro against HCV genotypes 1-6. It is excreted primarily via faeces, about 88% in an unchanged form while renal excretion accounts for approximately 7% of its elimination.
~DOSE OF SOFOSBUVIR: 400 mg tablet orally once daily with food (in the morning) for 12 weeks for adolescents with liver fibrosis Metavir score F0-F2.
~DOSE OF DACLTASVIR: 60 mg tablet orally once daily with food (in the morning) for 12 weeks for adolescents with liver fibrosis Metavir score F0-F2."
15914333|NCT03540199|Biological|Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Kidney Cancer|CIK cells was activated by PD-1 inhibitor and bispecific antibody of anti-CD3/MUC1
15914334|NCT03540199|Procedure|cryotherapy|the maximum tumor length≥2 cm，cool down the lesion,result in degeneration, necrosis or loss of the lesion.
15914335|NCT03540186|Dietary Supplement|Epigenorm Antivir|1 capsule of Epigenorm Antivir twice daily for 3 months
15914336|NCT03540186|Procedure|Acupuncture|Acupuncture involves inserting sterile needles into the skin. The needles do not go into the skin very far. Number of acupuncture sessions: no less than 15 sessions, based on the physician discretion
15914337|NCT03540160|Drug|5 mg Serlopitant Tablets|Serlopitant Tablets
15914338|NCT03540147|Device|Hokanson Cuffs|Each subject will participate in all (5) experimental arms. The order in which the experimental arms will be completed will be randomly assigned to the participant.
15914339|NCT03540147|Device|BStrong Bands|Each subject will participate in all (5) experimental arms. The order in which the experimental arms will completed will be randomly assigned to the participant.
15914340|NCT03540134|Device|Intracerebral Infusion of Autologous Cerebral Spinal Fluid|Unilateral infusion of 0.5 ml autologous CSF before DBS electrode insertion with MRI monitoring
15914341|NCT03540121|Behavioral|Video education + adherence contract|Participants will receive standard education along with the home-based video education plus an adherence contract. Following the baseline assessment, access to videos will be provided electronically so that the patient can watch them at home. The videos will be initially viewed in the following order: Video 1: Introduction, Video 2: Medications, Video 3: Your New Life. Approximately one month after transplant, after the video series has been viewed in its entirety, participants will receive an email link inviting participants to reflect on their goals about transplantation and pledging to taking their medications as directed. The contract will be non-enforceable, but it will provide patients with the opportunity to formally commit to a goal of taking the medications as prescribed. At 3 months, and 12 months, the participant will have the opportunity to reflect and modify adherence goals as desired.
15914342|NCT03540108|Dietary Supplement|Lactobacillus plantarum ECGC 13110402|The study will consist of two phases: a treatment period (12 weeks) with either the active or placebo and a wash-out period (4 weeks). Following a screening visit to ensure adherence to the inclusion criteria, the study will consist of a baseline, midpoint, endpoint (week 6 and 12, respectively) and washout visit (week 16).
15914343|NCT03540108|Dietary Supplement|Placebo Comparator: Maltodextrin|Please see intervention description above.
15914344|NCT03540095|Drug|Erector Spinae Plane Block|See arm description
15914345|NCT03540095|Drug|Paravertebral Nerve Block|See arm description
15914346|NCT03540082|Other|Tuck and Roll Group|An instructor will explicitly verbally and visually demonstrate the falling technique and provide feedback on participant performance. Each group will have 4 sessions to physically practice the skills with each practice session lasting about an hour.
15914347|NCT03540082|Other|Fall Exposure|An instructor will implicitly be exposed to the falling technique. Each group will have 4 sessions to physically practice the skills with each practice session lasting about an hour.
15914348|NCT03540069|Behavioral|Care Group Cervical Cancer Screening Education Curriculum|a multi-modal peer education curriculum directed at a multi-level audience and aimed at motivating women to seek cervical cancer screening services.
15914349|NCT03540056|Diagnostic Test|Ultrasound|We use ultrasound to measure the PRF and the testicular volumes.
15914350|NCT03540043|Drug|Administration of Placebo|Botanical Drug Phase 2 clinical study
15914351|NCT03540043|Drug|Administration of PUR0110 (Thykamine) 0.05%|Botanical Drug Phase 2 clinical study
15914352|NCT03540043|Drug|Administration of PUR0110 (Thykamine) 0.1%|Botanical Drug Phase 2 clinical study
15914353|NCT03540043|Drug|Administration of PUR0110 (Thykamine) 0.25%|Botanical Drug Phase 2 clinical study
15914354|NCT03540030|Drug|Gabapentin|opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
15914355|NCT03540030|Drug|Celecoxib|opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
15914356|NCT03540030|Drug|toradol|opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
15914357|NCT03540030|Drug|acetaminophen|opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
15914358|NCT03540030|Drug|regional block|opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
15914359|NCT03540030|Drug|propofol|opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
15914360|NCT03540030|Drug|IV lidocaine|opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
15914361|NCT03540030|Drug|rocuronium|opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
15914362|NCT03540030|Drug|vecuronium|opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
15914363|NCT03540030|Drug|sevoflurane|opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
15914364|NCT03540030|Drug|desflurane|opioid-free treatment pathway for shoulder arthroplasty with a focus on perioperative pain control and postoperative symptoms from treatment
15914365|NCT03540017|Drug|Cisplatin|Heated Intraperitoneal Chemotherapy will be administered after the completion of interval cytoreductive surgery after three cycles of neoadjuvant chemotherapy.
15914366|NCT03540004|Device|MolecuLight i:X Imaging Device|The i:X Imaging Device uses built-in light-emitting diodes (LEDs) emitting 405 nm violet excitation light to illuminate the wound during fluorescence imaging in (FL-Mode). The light excites biological components of the wound and surrounding tissues. Non-biological components may also fluoresce although their presence in wounds is less common, provided the wound has been cleaned following standard care protocols. The resulting wound fluorescence wavelengths emitted are typically between 420 - 700 nm in the visible wavelength spectrum. In FL-mode, a customized fluorescence emission filter, which is mechanically placed in front of the built in imaging sensor and allows real-time capture of wound, limits the visualization of fluorescence to wavelengths between 500-545 nm, which typically appears green in color, and 600-665 nm, which typically appears red in color.
15914367|NCT03539991|Other|Internet-Based Intervention|Complete online courses
15914368|NCT03539991|Other|Meeting|Participate in virtual meetings
15914369|NCT03539991|Other|Survey Administration|Ancillary studies
15914370|NCT03539978|Other|SM-THINk|Patients will receive the SM-THINk enhanced discharge method.
15914371|NCT03539952|Drug|TETA 4HCL|TETA 4HCL
15914372|NCT03539952|Drug|Penicillamine|Penicillamine
15914373|NCT03539939|Procedure|Coronally Advanced Flap|The coronally advanced flap (CAF) is a procedure frequently used in periodontal plastic surgery. The main objective of this surgical technique is to mobilize the gingival margin and reposition it at a level more coronal (incisal direction) than its original location. CAF is mainly used for the treatment of gingival recessions.
15914374|NCT03539926|Device|Lit-control®pH Meter|Alkalinization products will be used as standard clinical practice together with the pH monitoring through the Lit-control®pH Meter.
15914375|NCT03539926|Diagnostic Test|Reactive strips|Alkalinization products will be used as standard clinical practice together with the pH monitoring through the reactive strips.
15914376|NCT03539913|Biological|Probiotic : Saccharomyces boulardii|Treatment for 5 days
15914377|NCT03539913|Biological|Probiotic : Bacillus clausii|Treatment for 5 days
15914378|NCT03539900|Drug|Bupropion Hydrochloride, Naltrexone Hydrochoride Drug Combination|NB medication will combine BUPROPION HYDROCHLORIDE (360 mg/day) and NALTREXONE HYDROCHLORIDE (32 mg/day). Taken daily in pill form.
15914379|NCT03539900|Other|Placebo|Placebo will be inactive and taken daily in pill form.
15914380|NCT03539887|Drug|Intranasal ketamine|Intranasal ketamine will be prepared as 100mg/ml ketamine in 0.9% saline. An mucosal atomization device will be used to provide 5 intranasal applications of solution (volume 100 μl), separated by 3 minutes, over a total of 15 minutes. Each of five ketamine applications will provide 10 mg of study drug, for a total of 50mg. The dose to be used (0.5-1mg/Kg) is 6 to 18 times lower than the sedation dose (6-9mg/Kg).
15914381|NCT03539887|Drug|Placebo|Saline alone. An mucosal atomization device will be used to provide 5 intranasal applications of saline (volume 100 μl), separated by 3 minutes, over a total of 15 minutes.
15914382|NCT03539861|Device|Hemodialysis|Each patient will receive two hemodialysis treatments while on this study. The first hemodialysis treatment will be standard of care hemodialysis. The second treatment will be the experimental hemodialysis treatment using the Selective cytopheretic device.
15914487|NCT03539029|Procedure|Surgery|Surgical fracture fixation
15914384|NCT03539835|Other|Resistance training (RT)|Resistance training (RT) will include 15 repetitions for two sets and to exhaustion on the third set for seven major muscle groups: the leg and chest press, knee extension, leg curl, row, abdominal crunch, and bicep curl. Resistance is gradually increased to account for strength gains when subjects are able to complete 20 repetitions on the third set.
15914385|NCT03539835|Behavioral|Cognitively-based compassion training control (CBCT)|Cognitively-based compassion training control (CBCT) classes will be performed in a group setting for 1.5-2 hours per week, and consist of didactics, class discussion, and guided meditation practice. Each class will begin with a period of meditation to calm and focus the mind, followed by analytical practices designed to challenge unexamined assumptions regarding feelings, and actions toward others with a focus on generating spontaneous empathy and compassion for themselves and others.
15914388|NCT03539809|Dietary Supplement|L-Amino Acids|6 different ratios of the Branched-chain Amino Acids (BCAA) will be tested for 8 hours each.
15914389|NCT03539796|Procedure|Dural puncture epidurals (DPE)|Using the Arrow Epidural Kit (AK-05560) an epidural will be placed using the LOR to saline or air technique. A 26g Gertie Marx needle will be inserted through the Touhy epidural needle and used to puncture the dura; clear, free flowing CSF will return in the needle, but no medications will be injected. The 26g spinal needle will be removed, and the epidural catheter inserted through the epidural needle 3-5cm in the epidural space. A test dose with 3mL 1.5% Lidocaine with 1:200,000 epinephrine will be used to confirm the absence of intrathecal or intravascular catheter placement. The epidural catheter will then be dosed with 0.5% Bupivacaine in 5mL increments until a T4 dermatome level is reached. Epidural fentanyl 100mcg will be administered during initial dosing, and morphine-PF 3mg will be given via epidural after delivery of the fetus.
15914390|NCT03539796|Procedure|Traditional epidurals (EPI)|Using the Arrow Epidural Kit (AK-05560) an epidural will be placed using the LOR to saline or air technique. The catheter will be inserted 3-5cm in the epidural space. A test dose with 3mL 1.5% Lidocaine with 1:200,000 epinephrine will be used to confirm the absence of intrathecal or intravascular catheter placement. The epidural catheter will then be dosed with 0.5% Bupivacaine in 5mL increments until a T4 dermatome level is reached. Epidural fentanyl 100mcg will be administered during initial dosing, and morphine-preservative free (PF) 3mg will be given via epidural after delivery of the fetus.
15914391|NCT03539796|Procedure|Combined-spinal epidural technique (CSE)|Using the Arrow Epidural Kit (AK-05560) an epidural will be placed using the LOR to saline or air technique. A 26g Gertie Marx needle will be inserted through the Touhy epidural needle and used to puncture the dura; clear, free flowing CSF will return in the needle and 12mg bupivacaine, 10mcg fentanyl, 200mcg morphine-PF. The 26g spinal needle will be removed, and the epidural catheter inserted through the epidural needle 3-5cm in the epidural space. No epidural test dose will be given immediately compared to the above procedures secondary to intrathecal injection of local anesthetic with this CSE technique. Only after approximately 1 hour after intrathecal injection will a test dose of 3mL 1.5% Lidocaine with 1:200,000 epinephrine will be used to confirm the absence of intrathecal or intravascular catheter placement. The epidural catheter will then be dosed with 0.5% Bupivacaine for the remainder of the procedure if necessary.
15914392|NCT03539783|Diagnostic Test|Respiratory epithelial cell brushing|At specified time points, nasal brushings will be performed to obtain RNA.
15914393|NCT03539770|Procedure|Posterior spinal fusion|Surgical procedure that involves placement of spinal rods to correct spinal curvature
15914394|NCT03539757|Device|Non-Contrast Magnetic Resonance Imaging|The investigators plan to prospectively assess the correlation of liver fibrosis and congestion measurements obtained from novel, non-contrast MR imaging methods to histopathologic data obtained from a clinically-indicated liver biopsy in Fontan patients.
15914398|NCT03539731|Drug|Fluorine F 18 DASA-23|Given IV
15914399|NCT03539731|Procedure|Positron Emission Tomography|Undergo PET scan
15914400|NCT03539718|Drug|Taurolidine heparin|Taurolock-hep 500 at end of session
15914401|NCT03539718|Drug|Heparin Sodium|Heparin sodium 5000 at end of session
15914402|NCT03539705|Other|There is no intervention|There is no intervention
15914403|NCT03539679|Other|Encouraging physical activity.|Encouraging physical activity with motion sensor's feedback.
15914404|NCT03539666|Other|diet|dietary patterns
15914405|NCT03539640|Other|PEEP: 5 cmH2O|During second part of the study (MRI)
15914406|NCT03539640|Other|PEEP: 10 cmH2O|During second part of the study (MRI)
15914407|NCT03539640|Other|PEEP: 15 cmH2O|During second part of the study (MRI)
15914408|NCT03539627|Drug|Azilsartan Medoxomil 40 MG Oral Tablet [Edarbi]|patients are to receive azilsartan medoxomil
15914409|NCT03539614|Drug|Prazosin|This is an antagonist of the alpha1 receptor for noradrenaline. It is FDA approved for the treatment of hypertension, and has also been used for benign prostatic hypertrophy (BPH). Most recently, it has been found to be helpful for symptoms of PTSD in some but not all participants.
15914410|NCT03539614|Drug|Placebo|This is a capsule containing an inert substance, in order to provide blinding to participants and study staff of when participants are on active medication and when they are not during the later portions of the trial.
15914411|NCT03539601|Drug|Crisaborole ointment, 2%|Applied twice a day (BID)
15914412|NCT03539601|Drug|Hydrocortisone butyrate cream, 0.1%|Applied BID
15914413|NCT03539601|Drug|Pimecrolimus cream, 1%|Applied BID
15914414|NCT03539601|Drug|Crisaborole Vehicle|Applied BID
15914415|NCT03539588|Device|trigger point dry needling|placement of the dry needle into the muscle tissue to elicit a local twitch response. Only MYOTECH dry needles and ESTIM II dual channel stimulator will be used in this study. However we are not studying the equipment.
15914416|NCT03539588|Device|Electrical Stimulation|uses the dry needles as nodes to stimulate muscular contraction. Only MYOTECH dry needles and ESTIM II dual channel stimulator will be used in this study. However we are not studying the equipment.
15914418|NCT03539562|Drug|Morphine Sulfate and Promethazine|Morphine sulfate and promethazine
15914419|NCT03539549|Drug|Abicipar pegol|Abicipar pegol 2 mg administered to the study eye by intravitreal injection on Day 1 and Weeks 4, 8, 16, and 24.
15914421|NCT03539510|Behavioral|HF-ACP Website|Each module is broken down into weekly topics and each module takes 3-6 weeks to complete. Participants can access and review the material as often as needed as well as revisiting the information from modules they have completed.
15914422|NCT03539497|Diagnostic Test|Biomarker|Plasma mitochondrial DNA, plasma Cytochrome C
15914423|NCT03539484|Drug|RO7172508|RO7172508 was administered at a dose and as per the schedule specified in the respective arms.
15914424|NCT03539484|Drug|Obinutuzumab|In the event obinutuzumab treatment is implemented, obinutuzumab will be administered either on Day-7 or on Day-7 and Day-6. If obinutuzumab is given only on one day, then the schedule for Day-7 should be followed including an end of infusion sample.
15914425|NCT03539484|Drug|Tocilizumab|Tocilizumab was administered if required, for the management of severe CRS (cytokine release syndrome)
15914426|NCT03539471|Diagnostic Test|interview, Tridimensional Personality Questionnaire|interview of the residents about 15-20 minutes, then use Tridimensional Personality Questionnaire
15914427|NCT03539458|Device|Tendyne Mitral Valve System|Mitral valve replacement
15914428|NCT03539445|Drug|Butylphthalide|This group will receive a 3-month regimen of Butylphthalide and Sodium Chloride Injection 100ml twice/day in the initial 14 days and Butylphthalide Soft Capsules 0.2g triple/day for the rest Day 15 to Day 90.
15914429|NCT03539445|Drug|Butylphthalide Placebo|This group will receive a 3-month regimen of Butylphthalide Placebo Injection 100ml twice/day in the initial 14 days and Butylphthalide Placebo Soft Capsules 0.2g triple/day for the rest Day 15 to Day 90.
15914432|NCT03539406|Biological|UCB-NK cells|Intraperitoneal allogeneic UCB-NK cells infusion
15914433|NCT03539406|Drug|Chemotherapy|Cyclofosfamide/fludarabine treatment
15914434|NCT03539393|Drug|Fremanezumab|quarterly 675 mg dose (3 subcutaneous [SC] injections of 225 mg each).
15914435|NCT03539380|Drug|TRx0237|TRx0237 8 mg/day, with flexible dosing after 3 months (4-20 mg/day)
15914436|NCT03539367|Drug|ACETAZOLAMIDE oral capsule|Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m
15914437|NCT03539367|Drug|Placebo oral capsule|Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m
15914438|NCT03539354|Device|Temporary spinal cord stimulation|Percutaneous trial (temporary) electrodes are placed through a 14-gauge needle.The skin is entered at the medial aspect of the pedicle with the Tuohy needle usually angled 30-45° toward the midline for optimal entry into the epidural space at the interlaminar edge 1 or 2 levels of cephalad (usually, Th5-Th6 level). The 14-gauge needle is then passed with the bevel facing up at a 30-45° oblique angle to reach the depth of the midline laminar target.The Tuohy needle is then carefully removed and the operative site is cleaned with chlorhexidine and alcohol. Temporary stimulation is carried out till coronary artery bypass grafting surgery for 3 days, then stimulation turns off during surgery. At the end of coronary artery bypass grafting the temporary stimulation turns on in the intensive care unit and continues for 7 days. After that, the temporary leads will be removed.
15914439|NCT03539354|Procedure|Coronary artery bypass grafting|Standart coronary artery bypass grafting procedure.
15914440|NCT03539354|Drug|B-blockers|Standart b-blocker therapy will be administered in each group for AF prophylactics
15914441|NCT03539341|Behavioral|PLH-Thailand parenting programme|Parenting programmes include developing positive caregiver-child interaction through child-led play and emotional communication, praise and rewards to encourage positive child behaviour, limit-setting behaviours such as effective instruction giving and establishing consistent household rules, and non-violent discipline strategies to replace harsh parenting and corporal punishment.
15914442|NCT03539341|Other|Control (care as usual)|The control will be an inactive condition of standard care at the time of the intervention. 'Standard care' may include access to Parent Schools in Mother and Child Health clinics at public hospitals, which are provided in some provinces and districts in Thailand.
15914443|NCT03539328|Drug|Pembrolizumab|Humanized antibody used in cancer immunotherapy.
15914444|NCT03539328|Drug|Gemcitabine|Chemotherapy medication
15914445|NCT03539328|Drug|Paclitaxel|Chemotherapy medication
15914446|NCT03539328|Drug|Liposomal Doxorubicin|Chemotherapy medication
15914447|NCT03539315|Behavioral|ARCHES|Addressing Reproductive Coercion within Healthcare Settings (ARCHES) is a clinic-based intervention developed in the U.S., and involves training existing health providers to identify RC and IPV during standard family planning clinic-based counselling interactions. The intervention seeks to empower women with harm reduction strategies that minimize their risk for unintended pregnancy by offering a wide range of contraceptive options, providing counseling on correct and consistent use of contraception, and counseling on contraceptive methods that are difficult for a male partner to detect or block such as injectables or IUDs. ARCHES also facilitates access to violence support and counselling services by connecting women with community-based IPV services.
15914448|NCT03539302|Drug|Flecainide Acetate|Oral inhalation form using a nebulizer
15914449|NCT03539289|Behavioral|MUFA Diet|Control of patient MUFA Diet
15914450|NCT03539289|Behavioral|SFA Diet|Control of patient SFA Diet
15914451|NCT03539276|Behavioral|Knowledge exchange|OptimaMed
15914452|NCT03539263|Dietary Supplement|Bifihappy|"During the six weeks of treatment, the experimental group will take daily doses of 2,5 g with a concentration of 4x109 CFU/sachet of a mixture of lyophilised probiotic strains of the following species:
~Lactobacillus fermentum
~Lactobacillus rhamnosus
~Lactobacillus plantarum
~Bifidobacterium longum"
15914453|NCT03539263|Other|Placebo|During the six weeks of treatment, the experimental group will take daily doses of 2,5 g of maltodextrin
15914454|NCT03539250|Radiation|IMRT|IMRT with and without chemotherapy
15914488|NCT03539029|Procedure|Conservative treatment|immobilisation with plaster cast
15914455|NCT03539237|Other|Video demonstration of physical activity intensity levels|In the video demonstration, an approximately 50 year old male explains 1) light-intensity, 2) moderate-intensity, and 3) vigorous-intensity physical activity referring to differences in heart rate, breathing frequency and capability to talk normally. Simultaneously, on a treadmill he demonstrates the body signs of the three intensity levels. He gives examples and points out that there are individual differences in the intensity evaluation of comparable activities.
15914456|NCT03539224|Drug|Dolutegravir (DTG)|DTG 50 mg tablet will be orally administered once daily with or without food upto 48 weeks
15914457|NCT03539224|Drug|Lamivudine (3TC)|Lamivudine will be dispensed as 300 mg white, diamond shaped, scored, film coated tablets. It will be orally administered once daily with or without food upto 48 weeks.
15914458|NCT03539211|Other|Rotation Exercises|The subjects received 7 trunk rotation stability exercises x 10 reps each
15914459|NCT03539211|Other|Control Exercises|The subjects received 7 traditional exercises x 10 reps each
15914460|NCT03539198|Radiation|Proton Stereotactic Body Radiation Therapy (SBRT) (5 fractions; 3500-4500 cGy)|Patients will be receiving proton SBRT
15914461|NCT03539198|Radiation|Proton Stereotactic Body Radiation Therapy (SBRT) (3-5 fractions; various dose and fractionation regimens depending on treatment site).|Patients will receive proton SBRT.
15914462|NCT03539198|Drug|Nivolumab 3 mg/kg IV q2 weeks|Patients will receive Nivolumab x2 cycles before SBRT q2 weeks, and continued q2 weeks after SBRT until progression or at the discretion of the treating physician.
15914463|NCT03539198|Radiation|Proton or Photon SBRT (3-5 fractions; various dose and fractionation regimens depending on treatment site).|Patients with further oligoprogression (5 or fewer sites) will be eligible to receive additional SBRT to all sites of oligoprogression.
15914464|NCT03539185|Device|Videolaryngoscope Airtraq|Awake orotracheal intubation with laryngeal nerve block and remifentanil sedation
15914465|NCT03539185|Device|Fiberoptic bronchoscope|Awake nasotracheal intubation with laryngeal nerve block and remifentanil sedation
15914466|NCT03539172|Drug|Apatinib Mesylate|Apatinib Mesylate will be administered orally at 500 mg once daily from 2 weeks before the beginning of radiotherapy until the end of whole radiotherapy course
15914467|NCT03539159|Other|Allogeneic conventional sized serum eye drops|allogeneic serum conventional sized drops (40-50 µL, administrated using the Meise applicator) applied six times a day (when appropriate, lowering the dose to 3-4 times a day is allowed) for a period of one month
15914468|NCT03539159|Other|Allogeneic micro sized serum eye drops|Allogeneic serum micro eye drops (5-10 µL, administrated using the mu-Drop applicator) applied six times a day (when appropriate, lowering the dose to 3-4 times a day is allowed) for a period of one month
15914469|NCT03539146|Other|Dietary fiber|Intake of yogurt containing cascara with 0%, 3%, 7%,13% dietary fiber in a crossover design.
15914470|NCT03539146|Other|Control yogurt|Control yogurt
15914471|NCT03539133|Other|collection of clinical data|prospectively and systematically collection of clinical research data from STEMI patients
15914472|NCT03539120|Other|Follow up for survival|No intervention, this is an observational study of survival outcomes.
15914473|NCT03539107|Procedure|Retrograde bladder fill|Subjects will have their bladder retrograde filled with 300mL of fluid prior to a voiding trial.
15914474|NCT03539107|Other|spontaneous void|Subjects will not have retrograde fill of bladder, rather will be required to void 150 mL spontaneously prior to discharge.
15914475|NCT03539094|Other|Intermittent fasting|the subjects randomized to this group will do IF by restricting their diet and consuming few calories two days per week. During the days of fasting, subjects will be allowed to drink water, calorie-free beverages, and eat fresh, steamed or roasted non-starchy vegetables.
15914476|NCT03539081|Diagnostic Test|Dual-energy X-ray absorptiometry Scan|Body composition analysis will be obtained by DEXA scan.
15914477|NCT03539081|Other|Laboratory Measurements|The following labs will be obtained during the course of the study: pregnancy test (urine), glucose, insulin, catecholamine, and cholesterol (serum).
15914478|NCT03539081|Other|Blood Flow Measurement|The blood flow to the arm or leg may also be measured by placing an ultrasonic probe on the skin over the femoral artery of the leg and the brachial artery of the arm.
15914479|NCT03539081|Other|Continuous Blood Pressure|Continuous Blood pressure cuff will worn for 2 days with spinal cord stimulator on and off (24 hour on and 24 hour off). Optional procedure.
15914480|NCT03539081|Other|Partial pressure of oxygen|Transcutaneous recordings will be captured to measure the partial pressure of oxygen by placing monitors on the subject's chest and foot.
15914481|NCT03539081|Other|Microneurography|The sympathetic nervous system activity to the subject's leg muscles will be measured by a tiny microelectrode placed in the peroneal nerve in the leg located just below the knee on the outer part of the leg. When the nerve is located 2 tiny sterile microelectrodes will be inserted through the skin.
15914482|NCT03539081|Other|Anthropometric Measurements|Height and weight will be obtained.
15914483|NCT03539081|Behavioral|John Hopkins Restless Legs Severity Scale|Subjects will be administered questionnaires to evaluate RLS symptoms using John Hopkins Restless Legs Severity Scale.
15914484|NCT03539081|Behavioral|Continuous Blood Pressure Diary|Subjects participating in Continuous Blood Pressure monitoring will be administered continuous blood pressure monitoring compliance diary.
15914485|NCT03539068|Behavioral|WEB-ED+ Treatment Arm|"Veterans who screen positive on one or more mental health screens in WEB-ED will be eligible for RCT and those who consent and are randomly assigned to the WEB-ED+ Group. WEB-ED+ augments Current WEB-ED in a next step online interface via Pharos. If successful, this enhancement could be integrated into the next iteration of WEB-ED. Enhancements include:
~An eHealth interface tailored to Veterans' VA and MHV enrollment needs, links for an electronic interface with VA enrollment, MHV and MHV premium status enrollment, and secure messaging guidance.
~Shared decision making (SDM) interface: Veteran SDM-related educational (e.g., existing YouTube videos) and structured questions about treatment concerns, preferences, and questions and can be accessed through postal and email distribution or Pharos portal.
~Access to a health coach (the research coordinators) will be available through a toll-free number to assist both Veterans and providers/Transition Patient Advocates."
15914486|NCT03539055|Drug|Dabigatran Etexilate Oral Capsule|Oral use of Dabigatran etexilate for 90 days BID per product labeling for dosage to reduce incidence of device related thrombus after implantation of a Watchman LAA device.
15914489|NCT03539003|Drug|sevoflurane|anesthesia was induced with propofol (1.5 mg/kg) and target controlled infusion (TCI) of remifentanil (2-3 ng/mL of targeted effect site concentration (Ce). After intubation, inspired concentration of sevoflurane (0.8-1 MAC) and the Ce of remifentanil TCI (1.0-2.0 ng/ml) were adjusted to a BIS target level for hypnosis of 40-60 during surgery.
15914490|NCT03539003|Drug|desflurane|anesthesia was induced with propofol (1.5 mg/kg) and target controlled infusion (TCI) of remifentanil (2-3 ng/mL of targeted effect site concentration (Ce). After intubation, inspired concentration of desflurane (0.8-1 MAC) and the Ce of remifentanil TCI (1.0-2.0 ng/ml) were adjusted to a BIS target level for hypnosis of 40-60 during surgery.
15914491|NCT03539003|Drug|propofol and remifentanil|anesthesia was induced with an effect-site concentration of 3-4 μg/ml propofol and 2-3 ng/ml remifentanil using target-controlled infusion (TCI). After intubation, The effect site TCI of propofol (2-3 μg/ml) and remifentanil (1.0-2.0 ng/ml) was adjusted to maintain the desired hypnosis (40-60 of the BIS value) during surgery.
15914492|NCT03538990|Other|DASH Eating Pattern|The DASH diet is a heart-healthy eating pattern that is focused on adequate consumption of fruits, vegetables, whole grains, low-fat dairy, fish, poultry, beans, nuts, and vegetables oils while emphasizing limited intake of foods containing saturated fat, such as fatty red meats, full-fat dairy products, and tropical oils, such as coconut, palm kernel, and palm oils, as well as sugar-sweetened beverages and sweets.
15914493|NCT03538977|Procedure|Hydrotherapy|A re-sterilizable stainless steel bucket with an upper diameter of 30 cm, a depth of 32 cm, with water at a temperature between 37 and 38º Celsius will be used. The amount of water used will be sufficient to keep the baby submerged up to shoulder height. The baby will be immersed in the heated water of the bucket and will be suspended by occipital support performed by the physiotherapist, who alternates lateral-lateral and anteroposterior movements with only static suspension. The therapy will last from eight to ten minutes and will be discontinued if there is agitation, cyanosis, worsening respiratory distress or major evacuation. If the baby is using any type of ventilatory support or oxygen therapy, the same will be maintained during the procedure of hydrotherapy.
15914494|NCT03538977|Procedure|Conventional Physiotherapy|Conventional physiotherapy consists of manipulations of Thoracoabdominal Rebalancing, a registered technique which uses simultaneous passive stretching of inspiratory muscles and stimulation of the diaphragm. The manipulation used to improve the dynamic diaphragm included the thoracic-abdominal and lower abdominal support maneuvers. Back repositioning was used to minimize posteriorization of the ribs and costal kyphosis due to thoracic distortion.
15914495|NCT03538964|Procedure|toric intraocular lens|cataract surgery with implantation of an toric intraocular lens
15914496|NCT03538964|Procedure|non toric intraocular lens|cataract surgery with implantation of a non toric intraocular lens
15914497|NCT03538951|Drug|10% VDA-1102|200 mg twice-daily for 12 weeks
15914498|NCT03538951|Drug|20% VDA-1102|200 mg once-daily for 12 weeks
15914499|NCT03538938|Behavioral|1-Call Quitline Counseling|The 1-Call Quitline Counseling will be provided by the Wisconsin Tobacco Quit Line (WTQL) and consists of 1 proactive call using a standard, evidence-based protocol lasting approximately 20 minutes; ad hoc calls that are initiated by the participant are also available.
15914500|NCT03538938|Behavioral|4-Call Quitline Counseling|The 4-Call Quitline Counseling will be provided by the Wisconsin Tobacco Quit Line (WTQL) and consists of 4 proactive calls that use a standard, evidence-based protocol with each call lasting approximately 20 minutes; ad hoc calls that are initiated by the participant are also available.
15914501|NCT03538938|Drug|Nicotine patch|Nicotine Patch treatment will consist of a two week supply of over-the-counter nicotine patches (21 mg for those who smoke 10 or more cigarettes per day (CPD); 14 mg for those who smoke fewer than 10 CPD).
15914502|NCT03538938|Drug|Nicotine Patch and Nicotine Lozenge|The Nicotine Patch treatment will consist of a four week supply of over-the-counter nicotine patches (21 mg for those who smoke 10 or more cigarettes per day (CPD); 14 mg for those who smoke fewer than 10 CPD); the Nicotine Lozenge treatment will consist of a four week supply of over-the-counter nicotine lozenges (2-mg dose for those who do not smoke within 30 minutes of waking; 4-mg dose for those who smoke within 30 minutes of waking).
15914503|NCT03538938|Behavioral|SmokefreeTXT|SmokefreeTXT support is a national program offered at no cost to users (apart from data/minute costs charged by cellular providers about which enrollees are advised at enrollment) and is sponsored by the National Cancer Institute. This program sends up to 5 messages per day for up to 2 weeks prior to the target quit day and 6 weeks following the target quit day (total duration may be longer if participants elect to change the target quit day). The text messages offer tips to help enrollees achieve their goal of quitting smoking and offer real-time interactive tips when participants text in responses indicating cravings, negative moods, or slips. Participants have the option to reset quit dates and have the option to unsubscribe at any time by texting STOP to the program.
15914504|NCT03538938|Behavioral|No SmokefreeTXT|Proactive information about enrolling in adjunctive SmokefreeTXT text messaging support is not offered.
15914505|NCT03538938|Behavioral|Financial Incentives for Treatment Engagement|Incentives for treatment engagement are for each counseling session and for staying enrolled in SmokefreeTXT for six weeks. These incentives are designed to bolster motivation to stay engaged in treatment and to offset the costs and effort of treatment engagement (in terms of cell phone minutes).
15914506|NCT03538938|Behavioral|No Financial Incentives for Treatment Engagement|No Financial Incentives for Treatment Engagement are offered.
15914507|NCT03538925|Behavioral|AAC Generative Language Intervention|Parent/Caregiver AAC App Operational Training + Direct AAC Input-Output Language Intervention
15914508|NCT03538925|Behavioral|Standard of Care / Business as Usual|Parent/Caregiver AAC App Operational Training
15914509|NCT03538912|Other|Biomarker strategy|EAT duration is determined by β-D-1,3-glucan and mannan serum assays, performed at day 0 (day of EAT initiation) and day 3.
15914510|NCT03538912|Other|Routine strategy|EAT duration is based on IDSA guidelines, which recommend 14 days of treatment for patients without subsequent proven ICI, and who improve under antifungal treatment, or less in other situations.
15914742|NCT03537196|Drug|Sofosbuvir 400 mg and Daclatasvir 60 mg|All patients will receive sofosbuvir 400-mg and daclatasvir 60-mg (1 tablet each per day) during 12 weeks.
15914514|NCT03538886|Procedure|Coronary artery bypass grafting (CABG)|Revascularization of LAD lesion by CABG
15914515|NCT03538886|Procedure|Percutaneous coronary intervention (PCI)|Revascularization of LAD lesion by PCI
15914516|NCT03538873|Behavioral|Physical activity|
15914517|NCT03538860|Behavioral|Active comparator: Human interpreter|A Spanish-speaking patient is diagnostically assessed in-person by an English-speaking psychiatrist through a Spanish-speaking interpreter.
15914518|NCT03538860|Behavioral|Intervention: Asynchronous Telepsychiatry|A Spanish-speaking patient is interviewed in Spanish by a trained mental health interviewer. The interview is video-recorded in real-time, automatically translated into English with sub-titles added to the video file, and sent to a psychiatrist and to 3 English-speaking psychiatrists to asynchronously review the video and make a diagnosis.
15914519|NCT03538847|Other|Numerical rating scale|Measure of postoperative pain
15914520|NCT03538834|Dietary Supplement|Cod meal from residual material|Cod meal from residual material, 8 g protein daily for 8 weeks
15914521|NCT03538834|Dietary Supplement|Control|Placebo
15914522|NCT03538821|Dietary Supplement|Intact cod protein from fillet|Intact cod protein from fillet 8 g protein daily for 8 weeks
15914523|NCT03538821|Dietary Supplement|Intact cod protein from residual material|Intact cod protein from residual material, 8 g protein daily for 8 weeks
15914524|NCT03538821|Dietary Supplement|Control|Control group receive tablet containing fillers
15914525|NCT03538808|Drug|Varenicline|Participants will be provided varenicline medication
15914526|NCT03538808|Other|Placebo|Participants will be provided placebo medication
15914527|NCT03538795|Combination Product|iTBS&eCIMT|All will receive eCIMT+iTBS on an outpatient basis for 4 hours/day for 15 consecutive weekdays. eCIMT will include training of the more-affected arm following shaping principles, restraint of the less-affected arm, and the Transfer Package in combination with NDT techniques to reduce tone so that shaping of movement can be carried out. The Transfer Package is a set of behavioral techniques designed to transfer therapeutic gains from the treatment setting to everyday life. iTBS will be added to prime the areas of the brain that control movement of the more-affected arm so that the responsiveness of that tissue to motor training is enhanced. Treatment sessions will alternate between 10 minute periods of iTBS (which include time for set-up and transition) and 1-hour periods of eCIMT.
15914528|NCT03538782|Procedure|Percutaneous biliary drainage|The initial puncture of the bile duct with an access needle is performed by ultrasound guidance or by fluoroscopic guidance. After injection of the radiopaque contrast media into the bile duct system the rest of the examination is performed by fluoroscopic guidance. All different PTBD procedures are analyzed: insertion, exchange or removal of a plastic catheter, metal stent implantation, PTBD with cholangioscopy, PTBD with ballon dilatation, PTBD with lithotrypsy or diagnostic percutaneous transhepatic cholangiography.
15914529|NCT03538769|Other|electronic alert and clinical decision support system|Providers taking care of patients will receive an electronic alert and will be guided to use a clinical decision support system
15914530|NCT03538756|Device|Walkasins|Walkasins® consist of two parts for each leg: the leg unit and the foot pad. The leg unit wraps around the lower leg of the user and contains electronics for reading foot pad pressure signals, a microprocessor, and four vibrating motors that provide gentle tactile sensory cues to the front, back, medial, and lateral surfaces of the user's leg. These cues reflect real-time foot pressure information at a location above the ankle where skin sensation is still present.
15914531|NCT03538743|Drug|Placebo|Tablet, 0 mg, twice daily, 28 days
15914532|NCT03538743|Drug|PF-06882961|Tablet, 15 mg twice daily, 28 days
15914533|NCT03538743|Drug|PF-06882961|Tablet, 50 mg twice daily, 28 days
15914534|NCT03538743|Drug|PF-06882961|Tablet, 150 mg twice daily, 28 days
15914535|NCT03538743|Drug|PF-06882961|Tablet, 300 mg twice daily, 28 days
15914536|NCT03538743|Drug|PF-06882961|Tablet, dose TBD, twice daily, Cohort 5, 28 days
15914537|NCT03538743|Drug|PF-06882961|Tablet, dose TBD, twice daily, Cohort 6, 28 days
15914538|NCT03538743|Drug|PF-06882961|Tablet, dose TBD, twice daily, Cohort 7, 28 days
15914539|NCT03538743|Drug|PF-06882961|Tablet, dose TBD, twice daily, Cohort 8, 28 days
15914540|NCT03538730|Behavioral|Memory Reframing|The intervention will draw from existing narrative-based interventions, past pain memory reframing interventions and findings from our recent data. Specifically, parents will be taught to reminisce with their children about the in-hospital and post-surgery periods by encouraging children to provide more explanations, using less utterances about pain, avoiding repetitions, emphasizing positive aspects of the child's surgery memory (e.g., when children used coping methods such as deep breathing, when they got a treat), and enhancing children's self-efficacy regarding their ability to cope with pain.
15914541|NCT03538704|Drug|Metformin|Metformin is given to patients 1-1.5g/d.
15914542|NCT03538691|Drug|Brexpiprazole|Tablet
15914543|NCT03538691|Drug|Placebo|Tablet
15914544|NCT03538691|Drug|Citalopram Hydrobromide|Tablet
15914545|NCT03538691|Drug|Escitalopram|Tablet
15914546|NCT03538691|Drug|Fluoxetine|Capsules
15914547|NCT03538691|Drug|Paroxetine|Controlled-release tablets
15914548|NCT03538691|Drug|Sertraline|Tablet
15914549|NCT03538691|Drug|Duloxetine|Delayed-release capsule
15914550|NCT03538691|Drug|Venlafaxine Extended Release Oral Capsule|Extended-release capsule
15914551|NCT03538678|Other|Kwit smartphone app|Kwit smarphone app
15914554|NCT03538626|Biological|VRC-HIVMAB091-00-AB|The N6LS antibody binds to the CD4- binding site of HIV-1 gp120 protein and contains a methionine to leucine (L) and asparagine to serine (S) (M428L/N434S, referred to as (LS) change within the C- terminus of the heavy chain constant region to increase its binding affinity for the neonatal Fc receptor (FcRn).
15914652|NCT03537833|Other|pemetrexed-related hematological toxicity|hematological toxicity will be found on biologic data the day or the day before chemotherapy. Classification will based on NCI-CTCAE criteria
15914653|NCT03537820|Other|questionnaire|questionnaire EVAN-G
15914555|NCT03538626|Biological|EDP|Recombinant human hyaluronidase PH20 (rHuPH20) enzyme optimizes the SC delivery of co# administered therapeutics by depolymerizing hyaluronan (HA) in the extracellular matrix of the SC space that normally serves to restrict bulk fluid flow. rHP40 is the active ingredient in ENHANZETM Drug Product (EDP).
15914556|NCT03538587|Behavioral|Enhanced Mindfulness Intervention|"The 8-week EMI will consist of one initial in-person session with the child and parent, a series of at- home assignments, and two booster sessions. The psychoeducation group will be given educational material about coping with cancer."
15914557|NCT03538587|Behavioral|Psychoeducation|The psychoeducation group will be offered the opportunity to participate in the EMI 8 weeks post-baseline
15914558|NCT03538574|Behavioral|CBT-I|CBT-I is a behavioral treatment for insomnia
15914559|NCT03538574|Behavioral|MAP-I|MAP-I is a mindfulness meditation treatment for insomnia
15914560|NCT03538548|Behavioral|CBT-RP|CBT-RP is a time-limited, manual guided intervention that aims to develop behavioral and cognitive skills needed to initiate abstinence and prevent relapse. The treatment will help individuals analyze the decision making process to minimize the influence of more immediate reinforcement, develop cognitive strategies to promote the attainment of longer-term goals, practice behavioral strategies to reduce the influence of socially mediated threats to abstinence, and outline explicit plans for managing situations that threaten their goal of abstinence.
15914561|NCT03538535|Behavioral|Go/No-Go Active Learning (GOAL)|Behavioral Activation psychotherapy adapted to engage go/no-go learning
15914562|NCT03538522|Drug|N-831(Traneurocin) 10 mg QD|Oral administration of 10 mg capsule of NA-831 QD for 24 weeks
15914563|NCT03538522|Drug|NA-831 (Traneurocin) 20 mg QD|Oral administration of 20 mg capsule of NA-831 QD for 24 weeks
15914564|NCT03538522|Drug|NA-831 (Traneurocin) 40 mg QD|Oral administration of 40 mg capsule of NA-831 QD or for 24 weeks
15914565|NCT03538522|Drug|Placebo oral capsule QD|Oral administration of oral placebo capsule QD or 24 weeks
15914566|NCT03538509|Other|PCI and implantation drug eluting stent or bare metal stent|Percutaneous Coronary Angioplasty
15914567|NCT03538496|Drug|Bupivacaine Hcl 0.25% Inj|Single shot 20 ml 0.25 bupivacaine
15914568|NCT03538483|Drug|Bupivacaine Hcl 0.25% Inj|30 ml %0,25 bupivacaine
15914569|NCT03538483|Drug|Bupivacaine HCl Inj 0.25%|20 ml %0,25 bupivacaine
15914570|NCT03538470|Other|Spa Treatment|"Bath with immersion shower
~Overall penetrating shower
~Multiple local application cataplasm
~Individual physiotherapy
~Mobilisation pool"
15914571|NCT03538457|Drug|Paracetamol|Patients are tested for their normal prescription paracetamol medication
15914572|NCT03538444|Device|Repetitive Transcranial Magnetic Stimulation|Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive brain stimulation technique which is currently FDA-approved as a treatment for major depressive disorder
15914573|NCT03538444|Device|Sham rTMS|Participants will undergo procedures that mimic rTMS, but that are inactive.
15914574|NCT03538431|Drug|Buspirone|Buspirone is an atypical anxiolytic medication.
15914575|NCT03538418|Other|WAT|The WAT intervention consists of 12 weekly WAT-based exercise sessions and 7 sessions of support for BCTs and technical issues.
15914576|NCT03538405|Other|Supporting cushions|Cushions were placed in a way that the head and four limbs were well supported, without leaving empty space between body and cushions or mattress.
15914577|NCT03538405|Other|Harmonic techniques|Harmonic techniques (HT) is a group of manual techniques described by Lederman (2000).The goal of this techniques in this study was to reduce the muscle tone and additionally/subsequently increase the ROM.
15914578|NCT03538392|Device|Serranator® Alto|Serranator® Alto PTA Serration Balloon Catheter
15914579|NCT03538379|Behavioral|Bleeding Control Basic (B-Con) Course|The American College of Surgeons Bleeding Control Basic Course will be provided to participants. This course consists of a 30-minute lecture followed by 30-minutes of hands-on training in hemorrhage control technique application. It teaches how to apply manual pressure and how to apply a Combat Application Tourniquet (CAT). The course will not vary from its typical administration for this study.
15914580|NCT03538366|Other|Donor FMT|Fecal transplant from unrelated, healthy donors using enemas
15914581|NCT03538353|Other|pain education video|The video was made for the DOD and VHA to educate their soldiers and veterans about chronic pain.
15914582|NCT03538340|Procedure|Thoracic Epidural|The control arm will receive standard of care pain management which includes a Thoracic Patient Controlled Epidural
15914583|NCT03538340|Procedure|Intercostal Cryoanalgesia|The study arm will receive standard of care pain management which includes a Thoracic Epidural plus Intraoperative Intercostal Cryoanalgesia
15914584|NCT03538327|Drug|Silybin|After enrollment, all patients were encouraged to make lifestyle changes according with current guidelines, moreover it was also recommended to take silybin coniugated to vitamin E and phosphatidylcholine that shows higher intestinal absorption and bioavailability (Indena, IBI-Lorenzini spa Italy: Realsil®), as granules for oral solution at a dose of 3 g bid. Each subject was re-evaluated monthly performing a clinical examination to consider the opportunity of antihypertensive treatment. Finally, inflammatory, metabolic and hemodynamic parameters were assessed after 6 months of treatment. In particular, at the end of the follow-up period, a new OGTT was performed, to test the effects of silybin on glucose tolerance and IR status.
15914585|NCT03538314|Drug|UV1|UV1 (300 microgram)
15914586|NCT03538314|Drug|GM-CSF|GM-CSF (37,5 or 75 microgram)
15914587|NCT03538301|Drug|ND-L02-s0201|Intravenous administration every 2 weeks
15914588|NCT03538301|Drug|ND-L02-s0201|Intravenous administration every 2 weeks
15914589|NCT03538301|Other|Other: Placebo|Saline
15914590|NCT03538288|Device|rTMS|rTMS will be applied at 10 Hz to the DLPFC
15914591|NCT03538275|Other|Monitoring test|Participants wear Zephyr BioPatch for three 24-hour periods and ZMachine Insight for three sleep periods.
15914592|NCT03538249|Other|Aerobic training|
15914593|NCT03538249|Other|Inspiratory muscle training|
15914594|NCT03538249|Other|Resistance Training|
15914595|NCT03538249|Other|Aerobic and Inspiratory training|
15914596|NCT03538249|Other|Combined|Aerobic, inspiratory and resistance training
15914654|NCT03537807|Drug|Riluzole|For adult patients, one 40mg of BHV-0223, administered sublingually, on a twice daily basis (approximately every 12 hours).
15914655|NCT03537794|Diagnostic Test|PET scans|PET scans and PHNO scans
15914597|NCT03538236|Device|Intragastric balloon|Intragastric balloon insertion will be performed by an endoscopist under monitored anesthesia care. The Intragastric BalIoon (GB) comes as a deflated balloon pre-loaded on a catheter, which is inserted transorally into the proximal gastric body. An endoscope is then inserted alongside the device allowing for direct visualization of the balloon. Once in place, the intragastric balloon will be filled with saline through an external port. The balloon is inserted for 6 months then retrieved endoscopically
15914598|NCT03538236|Behavioral|Lifestyle intervention|All patients included in the study will undergo an evaluation by a nutritionist. All participants will receive recommendations for a diet. Participants will be instructed to keep a daily food diary and will meet with the nutritionist to reinforce the behavior every 12 weeks for 12 months.
15914599|NCT03538223|Other|Music Listening|Participants will undergo two different types of music before radiotherapy sessions
15914600|NCT03538223|Radiation|Radiotherapy|All participants will undergo radiotherapy according to breast cancer post surgery protocol
15914601|NCT03538197|Other|clinical and biological correlates|"To measure the rate of suicidal re attempt (SR) in a population of young adults aged 18 to 25 years.
~To identify sociodemographic, clinical and biological characteristics of a population of suicidal young people, in an attempt to highlight potential risk factors"
15914602|NCT03538184|Procedure|Piezosurgery|Preparation of implant beds entirely with piezo surgery implant tips
15914603|NCT03538184|Procedure|Drill|Preparation of implant beds entirely with conventional implant drills
15914604|NCT03538171|Drug|Entinostat|Entinostat will be repeatedly administered PO on days 1, 8, 15 and 22 of each treatment cycle. Exemestane PO once daily on day 1-28.
15914605|NCT03538171|Drug|Placebo|Patients receive Exemestane as in Arm A and placebo PO on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
15914606|NCT03538171|Drug|Exemestane|Exemestane PO once daily on day 1-28.
15914607|NCT03538158|Behavioral|Intervention Condition|Participants will have access to Fittle Senior which will provide guided exercises and social support from other participants of the study.
15914608|NCT03538158|Behavioral|Control Condition|Participants will have a paper booklet with suggested exercises that they may choose to complete for the duration of the study.
15914609|NCT03538132|Other|dental regenerative techniques|dental regenerative techniques
15914610|NCT03538119|Other|High intensity interval training program|"The HIIT protocol will consist of four four-minute high-intensity intervals, stimulating 85-95% peak-FC followed by active recovery at 70% peak-FC for a total of 20 minutes. The protocol will include a warm-up of 10 minutes at low moderate intensity (50-70% of maximal HR) and a 3 to 5 minute calm return period was performed at 50% of the HR peak.
~The supervised sessions will take place on a cycle ergometer and treadmill, 3 times a week for 6 consecutive weeks. If a session is lost, it will be recovered that week or the following week. Each session will be limited to three participants."
15914611|NCT03538119|Other|Moderate continuous training program|"The MCT protocol consists of continuously exerting moderate intensity, causing a peak FC-70-75% for 27.5 minutes to equal the energy expenditure of the HIIT protocol. The protocol will include a warm-up of 10 minutes at low moderate intensity (50-70% of maximal HR) and a 3 to 5 minute calm return period was performed at 50% of the HR peak.
~The supervised sessions will take place on a cycle ergometer and treadmill, 3 times a week for 6 consecutive weeks. If a session is lost, it will be recovered that week or the following week."
15914612|NCT03538093|Other|Experimental: Local Stabilization Exercise|"Inpatient phase (3-5 days): Day 1: lower limbs active mobilization on bed, abdominal breathing exercises, full body block twists. Day 2: manual transversus a. activation exercises, multifidus cross activation exercise, sitting on the edge of the bed. Day 3: bipedal stance, supervised gait reeducation, home care education, medical and physical therapy discharge with instructions.
~Outpatient phase:4th-6th week: hot compress + electrotherapy IFT (fr: 4kHz, AMF 100Hz, modulation 20Hz, 20 mins), stabilizer training. Hamstring, quadriceps, gluteus maximus and psoas stretching, stationary bicycle without load. 7th-9th week: stabilizer training elevating a leg, stationary bicycle low load. 10th-12th week: 1kg to elevated leg on stabilizer training, stationary bicycle moderate load."
15914613|NCT03538093|Other|Experimental: Global Stabilization Exercise|"Inpatient phase (3-5 days): Day 1: lower limbs active mobilization on bed, abdominal breathing exercises, full body block twists. Day 2: add obliques cross exercises in supine with contralateral leg, lumbopelvic bridge exercises, sitting on the edge of the bed. Day 3: add bipedal stance, supervised gait reeducation, home care education, medical and physical therapy discharge with instructions.
~Outpatient phase: physiotherapy: 4th-6th week: hot compress + electrotherapy IFT, lumbopelvic bridge exercises, obliques cross exercises. Hamstring, quadriceps, gluteus maximus and medius stretching, stationary bicycle without load. 7th-9th week: FST, global exercises, stationary bicycle low load. 10th-12th week: physiotherapy, side plank, unilateral bridge, stationary bicycle moderate load."
15914614|NCT03538093|Other|Experimental: Mixed Stabilization Exercise|"Inpatient phase (3-5 days): Day 1: lower limbs active mobilization on bed, abdominal breathing exercises, full body block twists. Day 2: manual transversus abdominis activation exercises, multifidus cross activation exercise, sitting on the edge of the bed. Day 3: bipedal stance, supervised gait reeducation, home care education, medical and physical therapy discharge with instructions.
~4th-6th week: hot compress + electrotherapy IFT, stabilizer training, hamstring, quadriceps, gluteus maximus and medius stretching, stationary bicycle without load. 7th-9th week: FST, global exercises, change stationary bicycle load to low load. 10th-12th week: physiotherapy, advanced global exercise (side plank), unilateral bridge,stationary bicycle moderate load."
15914615|NCT03538080|Device|ACCUVEIN plus ultrasound|"Intervention is marking of the saphenous veins with ACCUVEIN system. The AccuVein® AV400 vein illumination system is a laser imaging system that detects superficial veins up to 10 mm deep and digitally displays, through a projected red light, a map of the vascularization on the surface of the skin. in real time, allowing clinicians to check vein permeability and position.
~This system is portable and lightweight. It can be easily cleaned, and requires no calibration or adjustment. It does not require any contact with the patient. Second time is completion of marking by ultrasound if necessary"
15914616|NCT03538080|Device|Ultrasound only|Intervention is marking with ultrasound imaging as in usual practice.
15914656|NCT03537781|Behavioral|Food labelling versus no food labelling|Food labelling availability and satiety status
15914657|NCT03537768|Drug|Ulipristal Acetate|UPA Tablet
15914658|NCT03537768|Drug|Levonorgestrel|LNG Tablet
15914617|NCT03538067|Procedure|Percutaneous coronary intervention (PCI)|Patients will undergo PCI with intravascular ultrasound (IVUS) as part of standard clinical care in accordance with operator discretion. The research protocol will be observational - using IVUS to determine the effects of balloon inflation time, balloon inflation pressure, balloon type, atherosclerotic plaque morphology on stent expansion (minimal luminal area, MLA)
15914618|NCT03538054|Drug|Dextromethorphan|(1)10 mg, by mouth, twice daily every 12 hours.
15914619|NCT03538054|Drug|Placebo|1 capsule, by mouth, twice daily every 12 hours.
15914620|NCT03538041|Drug|Parsaclisib|Parsaclisib administered orally.
15914621|NCT03538028|Biological|INCAGN02385|INCAGN02385 administered as an intravenous infusion over 30 minutes.
15914622|NCT03538015|Drug|Carvedilol 3.125 mg|Participants will receive a 3.125 mg oral dose of carvedilol twice daily during the 4-week treatment period
15914623|NCT03538015|Drug|Carvedilol 2.5 mg|Participants will receive a 2.5 mg oral dose of carvedilol twice daily during the 4-week treatment period
15914624|NCT03538015|Drug|Placebo capsule|Participants will receive a matching oral dose of placebo capsule twice daily during the 4-week treatment period
15914625|NCT03538002|Device|Blue-light filtering spectacle lenses|This is a single vision spectacle lens for correction of distant refractions and filtering out the blue light by providing anti-blue light coating.
15914626|NCT03537989|Drug|Saline|To reduce the volume of saline administered during surgery of the colon and the rectum
15914627|NCT03537976|Other|Static Images and Facial Videos|2D and 3D still and video images obtained from each patient before surgery.
15914628|NCT03537963|Other|mHealth Stepped-care Intervention|Test of the feasibility and acceptability of an mHealth stepped-care intervention for sleep disturbance in HCT survivors, to compare with the control group.
15914629|NCT03537963|Other|Educational Control Condition|General health education for cancer survivors provided in NCI booklets entitled Facing Forward: Life After Cancer Treatment and Coping With Advanced Cancer.
15914630|NCT03537963|Other|Questionnaire|After the intervention, participants will be asked to complete a questionnaire to provide feedback on the intervention.
15914631|NCT03537963|Other|Interview|Qualitative interviews will be gathered after the participants have completed participation in the new intervention to gather data to inform future refinements of the intervention.
15914632|NCT03537963|Other|Qualitative Interviews|To conduct qualitative interviews with patients, caregivers, and clinicians regarding sleep disturbance in HCT survivors and on preferences for a new mHealth intervention for sleep disturbance. Separate panels of 10 HCT survivors, 10 caregivers who were the primary caregiver of an HCT survivor during or after the inpatient HCT hospitalization, and 5-10 HCT clinicians will be recruited for individual qualitative interviews via telephone or in person.
15914633|NCT03537963|Other|Virtual Reality|The intervention will comprise six 360º videos of relaxing natural landscapes from which patients can choose (i.e., beaches, tropical scenes, calm thunderstorms, snowfall). Participants will also choose an audio accompaniment: a progressive muscle relaxation script, a deep breathing exercise script, a mindfulness meditation script, or scene-relevant audio (e.g., waves crashing for the beach scene).
15914634|NCT03537950|Drug|PLC|Single oral dose of PLC.
15914635|NCT03537950|Drug|CBD|Single oral dose of cannabidiol (CBD) - 600mg.
15914636|NCT03537950|Drug|CBDV|Single oral dose of cannabidivarin (CBDV) - 600mg.
15914637|NCT03537937|Other|Lower SpO2 Target|SpO2 target 90% (range 88-92%)
15914638|NCT03537937|Other|Intermediate SpO2 Target|SpO2 target 94% (range 92-96%)
15914639|NCT03537937|Other|Higher SpO2 Target|SpO2 target 98% (range 96-100%)
15914640|NCT03537924|Drug|ACETAZOLAMIDE oral capsule|Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m
15914641|NCT03537924|Drug|Placebo oral capsule|Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m
15914642|NCT03537911|Behavioral|Cognitive Support Program|Three individual sessions of supportive psychoeducation, mindfulness practice, and strategy training (e.g., strategies to improve memory or concentration), with practice applying program content between sessions.
15914643|NCT03537898|Other|Lactated Ringer's|Lactated Ringer's will be used whenever an isotonic crystalloid is ordered
15914644|NCT03537898|Other|Normosol|Normosol-R pH 7.4 will be used whenever an isotonic crystalloid is ordered
15914645|NCT03537885|Diagnostic Test|Transcranial Direct Current Stimulation|Electrodes are placed on that head to deliver a non-invasive brain stimulation to the target area.
15914646|NCT03537885|Diagnostic Test|Transcranial Magnetic Stimulation|A coil is held tangential to the head in order to deliver a non-invasive brain stimulation to the target area.
15914647|NCT03537885|Diagnostic Test|Electroencephalography (EEG)|A cap is placed on the head with sensors to detect brain activity during the intervention.
15914648|NCT03537872|Behavioral|Miner-Friendly (MF) Service Venues TB/HIV Integration Strategies|"In addition to the control condition strategies (marked PS), the MF intervention includes additional strategies (marked MF):
~STRUCTURAL LEVEL Co-location of TB and HIV services (PS); Co-location of clinical and non-clinical services (MF); Demand creation (MF); Weekend service hours (MF) CLINIC LEVEL Intensified TB case finding and IPT (PS); Test and START (PS); Training for healthcare workers (PS); Job aids and mentorship for healthcare workers (MF) INDIVIDUAL/FAMILY LEVEL Health literacy for patients (PS); Family counseling (PS - limited); One-way SMS text messaging and lay counselor support for adherence and retention (MF); A menu of options for medication refills for miners unable to visit the clinic on a monthly basis (MF)"
15914649|NCT03537872|Behavioral|Public Sector (PS) Health Facilities TB/HIV Integration Strategies|STRUCTURAL LEVEL Co-location of TB and HIV services CLINIC LEVEL Intensified TB case finding and IPT; Test and START; Training for healthcare workers INDIVIDUAL/FAMILY LEVEL Health literacy for patients; Family counseling (limited); Adherence support from nurses and village health workers
15914650|NCT03537859|Other|Augmented Reality|Augmented reality children books. The books will have special markers. The device's camera will read the marker and show 2d and 3D animations with the book's theme.
15914651|NCT03537859|Other|Non Augmented Reality|Augmented reality book without electronic device. Since no electronic device will be provided, the children will not be able to see any augmented reality features of the book, making it a conventional children's book.
15914659|NCT03537768|Drug|Levonorgestrel|LNG Tablet (x2)
15914660|NCT03537755|Other|Observation|Examine thoughts and behaviors
15914663|NCT03537729|Behavioral|Salient Cues|Salient cues are those that capture the individual's attention. Information that is complex, novel, and difficult to identify takes more processing resources than those that are simple and familiar. Cues such as pictures and wall hangings, along with bright and meaningful signs, will be placed at key decision points within the senior communities.
15914664|NCT03537729|Behavioral|Spaced Retrieval Education|Spaced Retrieval (SR) is an evidence-based memory strategy that is used to teach individuals with memory loss new or previously known information. In this study, participants in Arm 3 will receive twelve 30-minute educational sessions to help them use the salient cues to find their way.
15914665|NCT03537716|Device|Treatment with High Intensity Focused ElectroMagnetic system|The treatment administration phase will consist of four (4) treatments, delivered twice a week. The applicator will be applied over the abdomen area. Visible contractions will be induced by the device.
15914666|NCT03537703|Combination Product|Active tDCS + Auditory Training|Active tDCS will be cathodal tDCS applied bilaterally over the auditory cortex for 20 min. The auditory training exercise will 20 min of computerized auditory training using the Sound Sweeps module of the Posit Science Brain HQ
15914667|NCT03537703|Combination Product|Active tDCS + Control Condition|Active tDCS will be cathodal tDCS applied bilaterally over the auditory cortex for 20 min. The control condition will be subjects watching a silent movie for 20 min during active tDCS stimulation.
15914668|NCT03537703|Combination Product|Sham tDCS + Auditory Training|Sham tDCS will be cathodal tDCS applied bilaterally over the auditory cortex for 1 min with the current then slowly ramped down to 0 amps over the course of another minute. The auditory training exercise will 20 min of computerized auditory training using the Sound Sweeps module of the Posit Science Brain HQ
15914669|NCT03537690|Other|Laboratory Biomarker Analysis|Correlative studies
15914670|NCT03537690|Drug|PEOX-based Polymer Encapsulated Paclitaxel FID-007|Given IV
15914671|NCT03537690|Other|Pharmacokinetic Study|Correlative studies
15914672|NCT03537677|Behavioral|Reduction in Sedentary Behavior|This 12-week intervention targets a reduction in prolonged sitting and includes provision of a wrist-worn activity prompter and in-person group sessions with behavioral counseling.
15914673|NCT03537664|Procedure|Root canal preparation|First endodontic treatment session includes the root canal preparation with Reciproc System and NaOCl 2.5%, followed by final irrigation protocol using activation techniques: XP Endo-Finisher and ultrasonic activation.
15914674|NCT03537664|Procedure|Intracanal medication|The second endodontic treatment includes the intracanal medication with calcium hydroxide paste, followed by an 2nd-visit root canal preparation
15914675|NCT03537651|Drug|TEZ|Fixed-dose Combination (FDC) tablet (TEZ/IVA)
15914676|NCT03537651|Drug|IVA|FDC tablet (TEZ/IVA)
15914677|NCT03537638|Behavioral|Multicomponent intervention|Intervention to rheumatologist and internist responsible for the care of patients with SLE. Implementation multicomponent intervention consisting of: educational component, a computerized clinical decision support system developed from the clinical practice guide - SLE and automated feedback integrated into the electronic medical record system.
15914678|NCT03537625|Dietary Supplement|Green tea|We made a dietary supplement from Cammellia sinesis O. Kunze, and made tablets containing extract.
15914679|NCT03537612|Drug|Clonidine|Intrathecal Clonidine 1 mcg/kg (up to 75 mcg) immediatey post-op; 100 mcg capsule TID Post op day 1-5 (liquid version available if subject cannot swallow capsule)
15914680|NCT03537612|Other|Morphine|Intrathecal spinal morphine (5 mcg / kg) immediatey post-op; Placebo capsule TID Post op day 1-5 (liquid version available if subject cannot swallow capsule)
15914681|NCT03537599|Biological|Daratumumab|Given IV
15914682|NCT03537599|Procedure|Donor Lymphocyte Infusion|Given via infusion
15914683|NCT03537599|Other|Laboratory Biomarker Analysis|Correlative studies
15914684|NCT03537586|Diagnostic Test|Diagnostic Coronary Angiography with Non-Obstructive CAD|Platelet activity in patients with and without CMVD (measured as a dichotomous variable) will be compared using the independent samples T-Test (for normally distributed data) of the Mean-Whitney U test.
15914685|NCT03537573|Behavioral|Usual Care/Guideline|The Usual Care group (also known as the Guideline group) follows the recent CDC guidelines and, when triggered by an opioid prescription during a qualifying visit, will be delivered real-time in a short checklist of recommendations to: 1) check the state-specific Prescription Drug Monitoring Program; 2) assess risk factors for opioid-related harms (e.g., history of substance use disorder, history of mental health problems, benzodiazepine use); 3) avoid extended-release or long-acting opioids; 4) use a low dose of immediate-release opioid for short period of time (3-7 days); and 5) consider non-opioid management such as acetaminophen, non-steroidal anti-inflammatory agents (NSAIDS), and physical therapy. Epic EHR order sets will be linked to enable easing ordering of non-opioid therapy.
15914686|NCT03537573|Behavioral|Opioid Justification|Providers will be required asked to enter a free text justification for their decision to prescribe an opioid analgesic for the acute pain condition. The provider will be notified that the justification provided will be visible in the Epic EHR. The provider has the option of entering a justification or not. If no justification is entered, nothing will be entered into the record (i.e., the Opioid Justification area in the encounter record will be left blank). The provider does not need to enter a justification if they choose to cancel the opioid prescription.
15914687|NCT03537573|Behavioral|Provider Comparison|Providers will receive monthly feedback via e-mail on their status in regards to initial opioid prescriptions for acute pain, adherence to safe opioid prescribing guidelines, and proportion of patients started on opioids or acute pain who transition to chronic opioid therapy (> 3 months). Providers in the lowest decile overall for proportion of patients with initial opioid prescriptions, unsafe opioid prescribing, and transition to chronic opioid therapy (> 3 months) will be given positive feedback for providing high quality, evidence-based care to their patients with acute pain. Providers outside the lowest decile will be notified they are outside the high quality, evidence-based care range and will be provided with their proportions compared to the high performers.
15914688|NCT03537547|Other|GeneSight Psychotropic test|GeneSight Psychotropic test, developed by AssureRx Health, is a genetic test that analyses pre-selected pharmacokinetics and pharmacodynamics genes and results in a composite phenotype and interpretive report, addressing both safety and efficacy of psychiatric medications.
15914689|NCT03537547|Drug|FDA-approved antidepressant or antipsychotic treatment|Participant is treated with medications included in the GeneSight Psychotropic product.
15914692|NCT03537521|Procedure|Urgent surgery which can not be postponed to the next 24 hrs|The urgent surgical intervention is not part of the registry protocol. The intervention is the acute event that leads to enrollment in the registry. It might be e.g. the surgical treatment of a trauma, fall, acute abdomen, appendicitis or anything else.
15914693|NCT03537508|Biological|MenACYW conjugate vaccine|Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine 0.5 mL, intramuscular
15914694|NCT03537508|Biological|MenACYW-135 conjugate vaccine|Meningococcal (Groups A, C, Y and W-135) oligosaccharide diphtheria CRM197 conjugate vaccine, 0.5 mL, intramuscular
15914695|NCT03537508|Biological|DTaP-IPV//Hib vaccine|DTaP-IPV//Hib vaccine at 2, 4, and 6 months of age, Intramuscular
15914696|NCT03537508|Biological|Pneumococcal 13-valent conjugate vaccine|Pneumococcal vaccine at 2, 4, 6, and 12 months of age, Intramuscular
15914697|NCT03537508|Biological|Pentavalent rotavirus vaccine|Rotavirus vaccine at 2, 4, and 6 months of age, oral solution
15914698|NCT03537508|Biological|Hepatitis B vaccine|Hepatitis B vaccine at 2 and 6 months of age, Intramuscular
15914699|NCT03537508|Biological|Measles, mumps, rubella (MMR) vaccine|MMR vaccine at 12 months of age, Subcutaneous
15914700|NCT03537508|Biological|Varicella vaccine|Varicella vaccine at 12 months of age
15914701|NCT03537508|Biological|Hepatitis A vaccine|Hepatitis A vaccine at 15 to 18 months of age
15914702|NCT03537495|Drug|Linezolid|"Overall, there is an urgent need for improvement of TBM treatment. LInezolid is known to be well-penetrated to blood brain barrier. A combination of high-dose rifampicin and linezolid as an intensified add-on therapy in the management of TB meningitis has never been studied.
~The goal is to assess the most appropriate dose of linezolid for larger follow-up studies and to evaluate the feasibility of a linezolid-containing TBM regimen."
15914703|NCT03537482|Drug|APG-2575|APG-2575 will be administered as an oral tablet
15914704|NCT03537469|Device|CTU Mega 20 real device|The CTU Mega 20 diamagnetic acceleration system discharges high-field magnetic impulses (with a duration of 5 ms and a period of 1000 ms), generating a magnetic field up to 2 Tesla, with a frequency of 7500 Hz in a volume of approximately 27 cm3.
15914705|NCT03537469|Device|CTU Mega 20 sham device|A CTU Mega 20 sham device (with an identical appearance to that of the real device) to avoid treatment identification by the patient or experimenter was used. Of course, the application of this sham device did not provide any magnetic field.
15914706|NCT03537456|Device|mRDX-02-17|"mRDX -02-17 is a dermal filler recommended for the correction and treatment of wrinkles and dermal depressions.
~It is a sterile and viscous aqueous solution of hyaluronic acid in a concentration of 1.5% (p/v) with acetyl tetrapeptide-9 and palmitoyl tripeptide-5, as auxiliary ingredients which is administrated by intradermal injections.
~This medical device encourages repair and restructuring of skin tissue and reduces the signs of aging.
~mRDX -02-17 is indicated for patients with hypotrophic tissues, Crow's feet, Glogau III-IV, all skin photo types (Fitzpatrick I - VI) and a WSRS score (Wrinkle Severity Ranking Scale) from 2 to 5."
15914707|NCT03537443|Dietary Supplement|Cholecalciferol (vitamin D3)|Prenatal and postpartum supplementation with vitamin D3 and/or placebo.
15914708|NCT03537430|Procedure|TNT uniportal VATS mediastinal tumor resection|TNT uniportal video-assisted thoracoscopic surgery refers to the use of conventional uniportal video-assisted thoracoscopic surgery, the use of laryngeal mask anesthesia instead of tracheal intubation anesthesia, intraoperative catheter was not retained, postoperative chest catheter placement.
15914709|NCT03537430|Procedure|Traditional uniportal VATS mediastinal tumor resection|The surgical procedures followed principles of mediastinal tumor resection，uniportal video-assisted thoracoscopic surgery in mediastinal tumor resection.
15914710|NCT03537417|Procedure|for thoracoscopic ablation of cervical sympathetic chain|bilateral thoracoscopic ablation of cervical sympathetic chain as a treatment for hyperhidrosis
15914711|NCT03537404|Drug|Narlaprevir|100 mg, film-coated tablets, taken as 200 mg per os daily
15914712|NCT03537404|Drug|Ritonavir|100 mg, film-coated tablets, taken as 100 mg per os daily
15914713|NCT03537404|Drug|Tenofovir Disoproxil Fumarate|300 mg, film-coated tablets, taken as 300 mg per os daily
15914714|NCT03537404|Drug|Raltegravir|400 mg, film-coated tablets, taken as 400 mg per os daily
15914715|NCT03537391|Diagnostic Test|Whole body contrast enhanced computer tomography|Computed tomography of the thorax, abdomen and pelvis will be performed as a part of routine clinical evaluation protocol. The imaging will be done with contrast agent if there are no clinical contraindications for the use of contrast agent.
15914716|NCT03537391|Diagnostic Test|99mTC-HMDP planar bone scintigraphy (BS)|Planar bone scintigraphy will be performed as a part of routine clinical evaluation protocol. The subjects will be positioned supine on a Discovery NM/CT 670 CZT, a digital SPECT/CT scanner (General Electric Healthcare). The scanner includes a dual-detector, free-geometry integrated nuclear imaging camera with the advanced digital CZT detector technology combined with the high-performance Optima CT540 subsystem. Whole-body planar images will be scanned from the anterior and posterior views three hours after the intravenous injection of 670 MBq of 99mTc-HMDP. A wide-energy high-resolution (WEHR) collimator, a scan speed of 13 cm/min, a zoom of 1.0 and a matrix size of 256 x 1024 are used in the scintigraphy.
15914717|NCT03537391|Diagnostic Test|99mTc-HMDP single photon emission computer tomography/computer tomography|SPECT/CT imaging will be carried out after acquisition of the planar images with the same scanner. Three bed positions of SPECT data will be acquired from the top of the head to mid femoral level using WEHR collimators. A non-circular orbit, 60 views with 15-s scanning time per view will be acquired during 180 degrees of rotation. A 128 x 128 matrix size, a zoom of 1.0 and 15% photopeak and lower scatter energy windows are used. After SPECT a CT topogram and a low-dose tomogram with a modulated mAs (noise index ~ 70), 120 kVp, a pitch of 1.35 and a 2.5-mm slice thickness are scanned. The co-registration of SPECT and CT data is verified after which the SPECT images are reconstructed using modern iterative ordered subsets expectation (OSEM) reconstruction algorithm from General Electric or Hermes Medical Solutions, which includes, e.g., 10 iterations and 5 subsets and attenuation, collimator and scatter corrections.
15914743|NCT03537196|Drug|Sofosbuvir 400 mg and Daclatasvir 90 mg|For HIV/HCV co-infected patients receiving efavirenz or nevirapine, daclatasvir dose will be increased to 90-mg per day.
15914783|NCT03536806|Drug|Saline 0.9%|Patients assigned to control group will be administered saline 0.9% in bolus of 10 cm3 within 2-3 minutes. BP will be measured before injection.
15915123|NCT03534050|Radiation|postoperative adjuvant RT|
15914718|NCT03537391|Diagnostic Test|Whole-body magnetic resonance imaging|Magnetic resonance imaging examination will be performed using a 1.5T (Philips 1.5T Ingenia, Best, Netherlands and/or Siemens 1.5T Aera/Avant, Erlangen, Germany) or 3T (Philips 3T Ingenia, Best, Netherlands and/or Siemens 3T Skyra fit, Erlangen, German) MR system. The body matrix coil in combination with a spinal coil will be used for image acquisition. T1-weighted anatomic imaging, STIR fat suppressed images and DWI will be performed in axial and coronal directions. DWI will be obtained with single-shot 2D spin-echo echo-planar imaging. The total scan time will be approximately 50 minutes.
15914719|NCT03537391|Diagnostic Test|Fluorine-18-prostate specific membrane antigen-1007- positron emission tomography/computer tomography|18F-PSMA-1007 is produced by radiolabelling with fluorine-18 produced by irradiating oxygen-18. Administration of the formulated solution is done shortly (<10h) after production. Imaging is carried out with digital PET/CT scanner (Discovery MI;General Electric Medical Systems, Milwaukee, WI, USA). The patients receive intravenous injection of 200-300 MBq (3 MB/kg) of 18F-PSMA-1007 diluted in 3-5 ml of saline as a 60-sec bolus which will be promptly flushed with saline. Before data acquisition patients will be asked to void. A static emission scan will be acquired 60-min from tracer injection over whole body. The sinogram data will be corrected for deadtime, decay and photon attenuation and reconstructed in a 256x256 matrix. Image reconstruction follows a fully 3D maximum likelihood ordered subsets expectation maximization algorithm incorporating random and scatter correction with two iterations and 28 subsets.The final in-plane full-width half-maximum of the systems is < 6 mm.
15914720|NCT03537378|Procedure|Hybrid APC|• HybridAPC is integrated with traditional APC and water-jet technique, which has been successfully applied for endoscopic treatment of mucosal lesions in GI, such as Barrett esophageal and lesions in colon. Submucosal injection of water jet can elevate superficial lesion, and then APC can be more effective in ablation of superficial tumor with a protection for muscular layer. The application of HybridAPC in respiratory intervention could theoretically protect cartilage, adventitia, reduce damage and formation of scare, and increase ablation energy to reach radical treatment. • High-frequency EBUS, could display the boundary between cartilage endomembrane and cartilage, in order to determine the depth of tumor.
15914721|NCT03537365|Dietary Supplement|Bovine Colostrum (BC) / intervention group|"Infants randomized to the intervention group will receive a maximum of 2.8 g bovine colostrum (BC, Biofiber, Gesten, Denmark), as the HMF added to 100 ml of MM and/or DM, when EN has reached a dose of 100-140 ml/kg/d and blood urea nitrogen (BUN) levels are below 5 mmol/l.
~The infants starts with 1 g (0.5 g protein) BC per 100 ml human milk on the first day, increased to 2 g (1.0 g protein) on day 3, and finally 2.8 g (1.4 g protein) on day 5, if the infants only receive DM.
~The intervention begins if the infants meet the inclusions criteria and the intervention lasts until the infants reach post menstrual age (PMA) 34+6 weeks or are discharged home (including participating in an early discharge program), or are transferred to non-participating neonatal units, whichever comes first."
15914722|NCT03537365|Dietary Supplement|FM85 / control group|"Infants randomized to the control group will receive a maximum of 4 g PreNAN FM85 (Nestlé, Vevey, Switzerland) as HMF, added to 100 ml MM and/or DM, when EN has reached a dose of 100-140 ml/kg/d and BUN levels are below 5 mmol/l.
~The infants starts with 1 g (0.35 g protein) FM85 per 100 ml human milk on the first day, which will be increased to 3 g (1.05 g protein) on day 3 and finally 4 g (1.4 g protein) on day 5, if the infants only receive DM.
~FM85 is the standard HMF used in all participating hospitals in Denmark. The infants will receive FM85 as the HMF as long as additional protein in the milk is needed."
15914723|NCT03537352|Procedure|Any appropriate surgical treatment|Any appropriate surgical treatment for the management of patient's current disorder
15914724|NCT03537352|Drug|Any appropriate drug or non-drug treatment excluding surgery|Any appropriate drug or non-drug treatment excluding surgery for the management of patient's current disorder
15914725|NCT03537339|Other|Record general information|Record general information of patients' sex, age, previous history, family history, electrocardiogram, echocardiography, cardiac biomarkers TnT, BNP, biochemical examination, and clinical treatment of the patients
15914726|NCT03537326|Drug|Budesonide|Patients will be given, on an empty stomach since a minimum of 10 hours, a single dose of 3 mg of Budesonide, in the form of Entocord® capsuls. After that, they will remain under medical control for at least an hour, and then will be back home with instructions to collect urine samples at defined times, during 4 days.
15914727|NCT03537313|Procedure|Vagina douching|Vaginal douches with 1000 ml of 1% povidone-iodine solution on the night before surgery and again on the morning of surgery
15914728|NCT03537313|Procedure|Vagina painting|Vaginal painting of vagina stump after hysterectomy with 10% povidone-iodine solution 30 ml
15914729|NCT03537300|Behavioral|DCF muscles training using pressure biofeedback in addition to conventional exercises|DCF muscles training using pressure biofeedback in addition to conventional exercises
15914730|NCT03537300|Behavioral|conventional exercises|conventional exercises
15914731|NCT03537287|Drug|17 alpha hydroxyprogestrone caproate|250 mg of 17 alpha hydroxyprogestrone caproate weekly
15914732|NCT03537287|Drug|Vaginal progesterone|200 mg of vaginal progesterone daily
15914733|NCT03537287|Drug|Oral dydrogesterone|2 tablets of dydrogesterone daily
15914734|NCT03537274|Biological|PEG-Intron|PEG-Intron is administered QW for 48 weeks by SC injection at 0.5, 1.0, and 1.5 mg/kg body weight. Body weight obtained at the baseline visit is used to calculate dosing.
15914735|NCT03537274|Biological|Interferon Alfa-2B|Interferon alfa-2b is administered TIW for 48 weeks by SC injection at 3 MIU regardless of participant body weight.
15914736|NCT03537261|Behavioral|Parent-based Crisis Prevention Institute (CPI) physical management training program (P-CPI)|Parents of children with ASD will be randomly assigned to the 6-hour P-CPI group training session, which includes nonverbal, paraverbal, verbal, and physical intervention techniques. Baseline measures will be administered on the day of training and follow-up measures at 2-week, 1-month, 2-month, and 3-month post baseline. The treatment group will also participate in an in-person follow-up group qualitative interview.
15914737|NCT03537248|Device|ASP-57|an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, ad storing soft contact lenses including silicone hydrogel lenses
15914738|NCT03537248|Device|ReNu® Multiplus|a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, ad storing soft contact lenses including silicone hydrogel lenses
15914739|NCT03537235|Device|Libramed|
15914740|NCT03537235|Device|Placebo|
15914965|NCT03535298|Drug|Escalation Therapies Group|Escalation MS Therapy group of medications
15914744|NCT03537196|Drug|Ribavirin|"In case of cirrhosis:
~Ribavirin will be added to sofosbuvir/daclatasvir during the 12 weeks of treatment. The dose will be adapted to the patient weight although the vast majority of patients (weight < 75 kg) will receive 500 mg x 2/day.
~In case of ribavirin contra-indication or side effects leading to ribavirin discontinuation, sofosbuvir/daclatasvir will be used 24 weeks."
15914745|NCT03537196|Drug|Sofosbuvir and Daclatasvir for 24 weeks|In case of cirrhose and of ribavirin contra-indication or side effects leading to ribavirin discontinuation, sofosbuvir/daclatasvir will be used 24 weeks.
15914746|NCT03537183|Other|Exercise training|12 weeks, 3 hours a week, moderate intensity exercise training
15914747|NCT03537157|Drug|Rifaximin delayed release tablets|Active intervention
15914748|NCT03537157|Other|Placebo|Comparator placebo
15914749|NCT03537144|Drug|Indomethacin|IV indomethacin will be given every 12 hours for 3 doses. If <48 hours old, 1st dose 0.2 mg/kg, 2nd dose 0.1 mg/kg, and 3rd dose 0.1mg/kg. If 2-7 days old, 1st dose 0.2 mg/kg, 2nd dose 0.2 mg/kg, and 3rd dose 0.2 mg/kg. If >7 days old, 1st dose 0.2 mg/kg, 2nd dose 0.25 mg/kg, and 3rd dose 0.25 mg/kg.
15914750|NCT03537144|Drug|Acetaminophen|15mg/kg/dose every 6 hours for 12 doses
15914751|NCT03537131|Drug|Dapagliflozin 10 MG Oral Tablet|taken once a day
15914752|NCT03537118|Procedure|Fluoroscopic + Ultrasound Guidance|Fluoroscopic Guidance Alone
15914753|NCT03537105|Procedure|Skin biopsies|Two skin biopsies (4mm punch) are performed under local anesthesia at the site of cutaneous inflammation/fibrosis.
15914754|NCT03537092|Device|Vaginal Film|"2 x 2 vaginal film with no active drug"
15914755|NCT03537079|Other|hypoxia air|Normobaric hypoxia is generated by adding azote in normal air to decrease the oxygen availability.
15914756|NCT03537066|Device|CPAP|All patients included will be treated by CPAP
15914757|NCT03537053|Behavioral|A plan to Move a Little and Often|"The intervention content is reported using the behaviour change technique (BCT) Taxonomy v1 (Michie, et al. 2013). The video will contain the BCT: information about health consequences. The booklet will consist of BCTs: self-monitoring of behaviour, goal setting behaviour, action planning, commitment, social support (practical), self-talk, and mental rehearsal of successful performance. Lastly, usage of the Facebook group will include BCTs: commitment, and social support unspecified, practical and emotional.
~Mental rehearsal, goal setting behaviour and action planning will be delivered through mental simulation exercises (Taylor, et al. 1998). BCTs self-monitoring of behaviour, goal setting behaviour, and commitment will be delivered using implementation intentions (Gollwitzer 1993)."
15914758|NCT03537040|Other|Method of Levels|Talking Therapy
15914759|NCT03537027|Dietary Supplement|Vitamin D3|In total 20 pills will be taken by the subjects, each containing 100 micrograms of vitamin D3, resulting in the total amount of 2000 micrograms of vitamin D3. Of the 20 pills, 10 will be taken in the morning with breakfast and 10 with lunch.
15914760|NCT03537014|Behavioral|Therapy|Non-directive therapy performed by therapist team
15914761|NCT03537014|Drug|MDMA|Administration of 80 to 120 mg MDMA during three sessions of MDMA-assisted psychotherapy followed by a supplemental dose of 40 or 60 mg MDMA offered 1.5/2 hrs after the initial dose, respectively.
15914762|NCT03537014|Drug|Placebo|Administration of placebo during three sessions of MDMA-assisted psychotherapy
15914763|NCT03537001|Other|Penthrox|Self-administration of penthrox by the patient under the supervision of a physician trained in its administration, in strict compliance with its MA.
15914764|NCT03536988|Procedure|TAMIS-IPAA|In TAMIS-IPAA group, transanal minimally invasive surgery of IPAA will be performed.
15914765|NCT03536988|Procedure|Lap-IPAA|In Lap-IPAA group, transabdominal minimally invasive surgery of IPAA will be performed.
15914766|NCT03536975|Other|Platform|"The groups will be comprised of one intervention group with access to the web platform CAREGIVERSPRO-MMD and another control group without any access to it"
15914767|NCT03536962|Other|no intervention|no intervention
15914768|NCT03536949|Drug|RVL-1201|RVL-1201 ophthalmic solution, 0.1%
15914769|NCT03536949|Other|Vehicle ophthalmic solution|Vehicle placebo ophthalmic solution
15914770|NCT03536923|Device|Leva Incontinence System For Pelvic Floor Muscle strengthening|The leva device is placed vaginally for 2.5 minutes twice daily, and pelvic floor muscle exercises are performed based on guidance from data sent from the device to their mobile phone.
15914771|NCT03536910|Other|Copeptin|Level of copeptin in maternal blood and umbilical cord blood
15914772|NCT03536897|Radiation|IORT|Intraoperative radiation therapy with INTRABEAM system to a dose of 20 Gy
15914773|NCT03536884|Drug|Bimekizumab|Subjects will receive bimekizumab at pre-specified time-points.
15914774|NCT03536884|Drug|Secukinumab|Subjects will receive secukinumab at pre-specified time-points.
15914775|NCT03536884|Other|Placebo|Subjects will receive placebo at pre-specified time-points to maintain the blinding in the double-blind Treatment Period.
15914776|NCT03536871|Dietary Supplement|multi-nutrient supplement|Compare the effects of a multi-nutrient supplement following a healthy lifestyles program in healthy young men and women, healthy older men, and sarcopenic older men.
15914777|NCT03536871|Other|Exercise|We will evaluate the effect of 12 weeks of combined endurance and resistance home-based exercise in younger and older adults.
15914778|NCT03536858|Behavioral|COACH (Communicating about Choices in Transplantation)|COACH is a behavioral communication intervention designed specifically for ESRD patients pursuing kidney transplantation. The COACH program consists of four modules: 1) Kidney transplant options, 2) Discussing your transplant options, 3) Requesting living donation, and 4) Maintaining positive relationships. The content and teaching strategies were guided by the concepts of social cognitive theory as well as principles of adult learning and communication skill acquisition. We believe that patients will transfer these skills to other patients at the hemodialysis clinic who are on their shift.
15914779|NCT03536845|Drug|Vitamin D 3|oral drops
15914780|NCT03536832|Procedure|Cesarean Section with Vicryl|Pfnannenstiel incision will be done under general or spinal anaesthesia. The abdomen will be opened and fetus and plasenta will be delivered. Then abdomen will be closed. Skin will be closed with Vicryl.
15914781|NCT03536832|Procedure|Cesarean Section with Prolen|Pfnannenstiel incision will be done under general or spinal anaesthesia. The abdomen will be opened and fetus and plasenta will be delivered. Then abdomen will be closed. Skin will be closed with prolen.
15914782|NCT03536819|Device|Votiva|The applicator uses radio-frequency energy to treat the vaginal canal
15914784|NCT03536806|Drug|Canrenone|Patients assigned to canrenone group will be administered canrenone in bolus of 200 mg diluted to 10 cm3 within 2-3 minutes in one dose. Drug administration will be stopped in case of serious adverse event. Further treatment of the patient will depend on clinical condition and will follow appropriate clinical guidelines.
15914785|NCT03536780|Drug|Avelumab and Gemcitabine|"Avelumab: 10 mg/kg by IV infusion over 1 hour, every 2 weeks
~Gemcitabine: 1000 mg/m2 by IV infusion over 30 minutes on Days 1, 8, and 15 of each 28-day cycle"
15914786|NCT03536767|Drug|AG10|AG10 800mg twice daily, oral administration
15914787|NCT03536754|Other|Placebo|Placebo
15914788|NCT03536754|Drug|CCX140-B|CCX140-B is an orally administered selective antagonist of CCR2
15914789|NCT03536741|Procedure|TAP block and RS block + General Intravenous Anesthestic|transversus abdominis plane block and rectus sheath block
15914790|NCT03536741|Drug|General Intravenous Anesthetic|General Intravenous Anesthetic
15914793|NCT03536702|Other|Creative Writing Workshop|This group will participate in a writing workshop in group sessions.
15914794|NCT03536702|Other|Independent Writing - Control Group|This group will receive a book for a self writing session.
15914795|NCT03536689|Diagnostic Test|Amniotic fluid index|Ultrasonography of the amniotic fluid level in each 4 quadrants of uterus then summerize as one value to measure the quantity of amniotic fluid index
15914796|NCT03536676|Other|'Egg-cellent' Breakfast in the Classroom|Includes the additional 2 eggs per day
15914797|NCT03536676|Other|Breakfast in the Classroom|Receives the standard meal for Breakfast in the Classroom
15914798|NCT03536663|Device|Optiflux and Dialyzer with Endexo|Hemodialysis (HD) on Optiflux dialyzer from Visit 1 to 12 and followed by HD on the dialyzer with Endexo at visit 13 and continues until visit 50. Dialysis is performed 3 times per week which means the total of the intervention will be 17 weeks.
15914799|NCT03536650|Device|DMR|"Procedure: DMR Procedure The Fractyl DMR procedure using the Revita System utilizes an over the wire endoscopic approach to ablate the duodenum. The procedure may be completed in an endoscopic suite or in an operating room depending on the facilities and support at each investigative site. All subjects are monitored and anesthetized by conscious sedation per each facility's standard protocol. A full DMR procedure is defined as 5 complete ablations or 9 axial centimeters of circumferentially ablated tissue in the duodenum. Subjects who do not receive any ablations during the DMR procedure will be followed for safety through the 4 week visit and then discontinued from the study.
~Other Names:
~DMR Revita"
15914800|NCT03536637|Drug|DMT310|Topical Powder
15914801|NCT03536637|Drug|Hydrogen Peroxide|Liquid Diluent
15914802|NCT03536637|Drug|Placebo|Placebo Topical Powder
15914803|NCT03536624|Behavioral|6 days spa residential program|6 days spa residential program combining psychological intervention, physical activity, thermal spa treatment, health education and corrections of eating disorders.
15914804|NCT03536611|Drug|dabigatran|dabigatran etexilate 110 mg bid + aspirin 100 mg qd + clopidogrel 75 mg qd for 1 month followed by dabigatran 110mg bid + clopidogrel 75mg/d for at least 5 months
15914805|NCT03536611|Drug|warfarin|warfarin (according to clinical routine monitoring of INR, maintain the therapeutic range at 2.0-3.0) + aspirin 100 mg qd + clopidogrel 75 mg qd for 1 month followed by warfarin + clopidogrel 75mg/d for at least 5 months
15914806|NCT03536598|Drug|Amlodipine 10 mg + Valsartan 160 mg + Rosuvastatin 20 mg|
15914807|NCT03536598|Drug|Amlodipine 10 mg + Valsartan 160 mg|
15914808|NCT03536598|Drug|Valsartan 160 mg + Rosuvastatin 20 mg|
15914809|NCT03536585|Device|Vulvovaginal treatment|"Radiofrequency and pulsed electro-magnetic fields treatment of the vaginal canal to maintain an internal temperature of approximately 42 C for the proximal thermometer and 45 C for the mid and distal thermometers for 15 minutes.
~Radiofrequency and pulsed electro-magnetic fields treatment of the labia to maintain an external temperature of approximately 40 C - 45 C for 15 minutes.
~Radiofrequency and pulsed electro-magnetic fields treatment of the mons pubis to maintain an external temperature of approximately 40 C - 47 C for 15 minutes."
15914810|NCT03536585|Device|Baseline|Subject is acting as their own control. The baseline general appearance photograph will act as the comparator.
15914811|NCT03536572|Behavioral|Sleep Apnea Self-Management Program|Protocol-based sleep apnea and CPAP education and support
15914812|NCT03536559|Drug|CNM-Au8|CNM-Au8 is a dark red/purple-colored liquid formulation consisting of a stable suspension of faceted clean surfaced elemental gold nanocrystals in buffered deionized water with a concentration of up to 0.5 mg/mL of gold. The formulation is buffered by sodium bicarbonate present at a concentration of 0.546 mg/mL. There are no other excipients. The drug product is formulated to be taken orally and will be provided in single dose HDPE containers. The study doses vary by the concentration of gold nanocrystals per milliliter in a volume of 60 mL.
15914813|NCT03536559|Drug|Placebo|Placebo is liquid with identical color and taste
15914814|NCT03536546|Behavioral|Alcohol Peer Mentor Intervention|A Veteran Peer research assistant will have contact with a study participant once in person in the emergency department at enrollment, and up to 6 times after enrollment over the course of 2 months. Participants will receive brief advice from a peer. Brief advice content will be based on strengths-based discussions with participants regarding their drinking and personal goals and preferences. Participants will also receive a resource pamphlet on alcohol and other health issues. Follow-up contact will be made by phone. The content of the follow-up peer intervention will be based on the manual developed by the study team to address strengths-based intervention topics.
15914815|NCT03536546|Behavioral|Brief Advice|Participants will receive brief substance use advice from a non-peer research staff member in the emergency department. Brief advice content will mirror standard care practices currently provided in VHA when a patient endorses hazardous drinking behaviors. Participants will also receive a resource pamphlet on alcohol and other health issues.
15914816|NCT03536533|Other|Exergame|Each of the 8 exercise sessions will last at least 42 minutes, with an actual training duration of 21 minutes. The participants will be accustomed gradually to the game. On one hand this will be achieved by increasing the difficulty in subsequent levels within the exergame.
15914966|NCT03535285|Procedure|Periodontal ligament distraction|decrease the bony resistant during canine retration
15914817|NCT03536520|Drug|ACETAZOLAMIDE oral capsule|Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m
15914818|NCT03536520|Drug|Placebo oral capsule|Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m
15914819|NCT03536507|Drug|ACETAZOLAMIDE oral capsule|Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m
15914820|NCT03536507|Drug|Placebo oral capsule|Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m
15914821|NCT03536494|Behavioral|Review the use of mirabegron and its discontinuation|"A structured intervention was designed consisting of four major sections:
~General practitioners: information and training with written material and patient-centred prescribing.
~Specialized hospital care: information regarding the intervention for urologists and gynaecologists.
~Management support with the definition of a structured strategy.
~Monthly monitoring of the intervention."
15914822|NCT03536481|Drug|ensartinib capsules (test product)|Test product(T)：100mg ensartinib capsules manufactured by Betta Pharmaceuticals
15914823|NCT03536481|Drug|ensartinib capsules (reference product)|Reference product(R)：100mg ensartinib capsules manufactured by Catalent Pharma Solutions
15914824|NCT03536455|Drug|ACETAZOLAMIDE oral capsule|Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m
15914825|NCT03536455|Drug|Placebo oral capsule|Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m
15914826|NCT03536429|Drug|ACETAZOLAMIDE oral capsule|Administration of 1x125mg acetazolamide in the morning, 2x125mg in the evening, starting 24 hours before departure to 3'100m
15914827|NCT03536429|Drug|Placebo oral capsule|Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3'100m
15914828|NCT03536416|Behavioral|My Asthma in School|The intervention will include three arms. During the theatre workshop, the children will watch a theatre performance, and engage in a discussion at the end of the play, about what they have watched. The self-management workshops will cover a range of topics identified as barriers to self-management in our earlier study, and will be delivered to children with asthma only. The control group will receive usual care during the intervention.
15914829|NCT03536403|Radiation|EOS X-rays|EOS X-rays is done with et without a kyphosis induced corset
15914830|NCT03536403|Other|8-meters walk test|8-meters walk test measured by optoelectronic Vicon system with et without a kyphosis induced corset
15914831|NCT03536390|Drug|Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT)|Methylphenidate Hydrochloride (HCl) Extended Release Chewable Tablet (ERCT)
15914832|NCT03536390|Drug|Placebo|Placebo
15914833|NCT03536377|Other|very low calorie liquid diet|Phase 1: very low calorie liquid formulation Phase 2: Nutritionally balanced solid diet Phase 3: Educational material
15914834|NCT03536364|Behavioral|Food Order|carbohydrate (ciabatta bread ) first, followed 10 minutes later by protein (grilled chicken) and vegetables
15914835|NCT03536364|Behavioral|Carbohydrate Last|protein and vegetables first, followed 10 minutes later by carbohydrate
15914836|NCT03536364|Behavioral|Vegetables first|vegetables first, followed 10 mins later by protein and carbohydrate.
15914837|NCT03536351|Behavioral|Interdisciplinary process drama|Process drama program (3 days/week, 12 weeks, 1-1.5 hours per session) of movement-based activities combining music and drama. Activities that target understanding of emotions, intentions, and appropriate social interactions have been planned by a team of drama teachers, occupational therapists, and speech-language pathologists.
15914838|NCT03536338|Other|Spinal Stimulation|transcutaneous electrical stimulation of the lumbar spinal cord during rehabilitation.
15914839|NCT03536338|Other|Sit-to-stand Training|Rehabilitation of standing from a chair using the Keiser Rack
15914840|NCT03536325|Drug|Guselkumab Dose 1|Participants will receive Dose 1 of guselkumab on Day 1.
15914841|NCT03536325|Drug|Guselkumab Dose 2|Participants will receive Dose 2 of guselkumab on Day 1.
15914842|NCT03536325|Drug|Guselkumab Dose 3|Participants will receive Dose 3 of guselkumab on Day 1.
15914843|NCT03536325|Drug|Placebo|Participants will receive matching placebo on Day 1.
15914844|NCT03536312|Procedure|Thoracic Aortic Surgery|Thoracic aortic surgery to treat thoracic aortic aneurysm
15914845|NCT03536299|Other|Dual-task gait|During the training sessions, you will participate in gait training with a physical therapist (PT). You will be asked to walk in 2-minute bouts and you will be provided with adequate rest breaks to help manage your fatigue levels. In addition to performing the gait training activities, you will be asked to perform thinking tasks at the same time. These pre-recorded questions or prompts will be provided to you through headphones and a portable music player. This is to help ensure that the PT is able to focus on giving you feedback about your walking ability and answers to the thinking tasks, and on your safety. At the end of each session, you will have walked for a total walking time of 20 minutes.
15914846|NCT03536299|Other|Single-task gait|During the training sessions, you will participate in gait training with a physical therapist (PT). You will be asked to walk in 2-minute bouts and you will be provided with adequate rest breaks to help manage your fatigue levels. At the end of each session, you will have walked for a total walking time of 20 minutes.
15914847|NCT03536286|Behavioral|Encouragement|Households will be visited and encouraged to enroll in Asili
15914848|NCT03536273|Other|Pilates Group Exercises|For 12 weeks, 3 repetitions per week
15914849|NCT03536260|Device|Implant with NanoBone graft|Using of NanoBone graft to fill the gap in the socket after immediate implant placement
15914850|NCT03536260|Device|Implant with Xenograft|Using of Xenograft to fill the gap in the socket after immediate implant placement
15914851|NCT03536247|Procedure|Initial therapy with papillary balloon dilation|patients will first undergo papillary dilation
15914852|NCT03536247|Procedure|Initial therapy with intraductal lithotripsy|patients will first undergo intraductal laser or electrohydraulic lithrotripsy
15914853|NCT03536234|Drug|Triptorelin acetate depot|3.75 mg triptorelin depot (monthly injections). 3 doses in total
15914854|NCT03536208|Drug|Warfarin|5 different doses of warfarin will be assigned, ranging from 1mg to 5 mg.
15915011|NCT03534934|Other|Questionnaires|Subject Questionnaire Calcium Intake Questionnaire Home and Work Activities Survey
15914855|NCT03536182|Radiation|Carbon Ion Radiation Therapy (CIRT)|Patient will receive CIRT daily, 4 days a week for a total of 12 fractions/treatments plus concurrent chemotherapy (gemcitabine) weekly for 3 weeks. Gemcitabine will be given intravenously over about 1 hour in the outpatient clinic. Within 6 weeks of completing radiotherapy, patient will start 4 cycles of chemotherapy. If the doctor chooses gemcitabine+nab-Paclitaxel, patient will receive gemcitabine and nab-paclitaxel intravenously once a week for 3 weeks then 1 week off, for a total of 4 cycles (16 weeks). If the doctor chooses FOLFIRINOX, then patient will receive oxaliplatin, irinotecan, infusional 5-fluorouracil, and possibly leucovorin, all intravenously, every 2 weeks, for a total of 16 weeks.
15914856|NCT03536182|Radiation|Intensity Modulated Radiation Therapy (IMRT)|Patient will receive IMRT daily, 5 days a week for a total of 28 fractions/treatments plus concurrent chemotherapy (gemcitabine or capecitabine) weekly for 5 weeks. Gemcitabine will be given intravenously over about 1 hour in the outpatient clinic,within 6 weeks of completing radiotherapy,patient will start 4 cycles of chemotherapy. If the doctor chooses gemcitabine+nab-Paclitaxel, patient will receive gemcitabine and nab-paclitaxel intravenously once a week for 3 weeks then 1 week off, for a total of 4 cycles (16 weeks). If the doctor chooses FOLFIRINOX, then patient will receive oxaliplatin, irinotecan, infusional 5-fluorouracil, and possibly leucovorin, all intravenously, every 2 weeks, for a total of 16 weeks.
15914857|NCT03536156|Other|Four intra-oral optical impression taken successively|"Four intra-oral optical impression images will be taken successively on a patient:
~Optical impressions are designed to record adjacent implant site teeth and peri-implant soft tissue PEI using an Optical Camera. The optical camera works like a camera and does not come into contact with the patient's mucous membranes or teeth. The images obtained are saved in STL format on an anonymized file.
~The 4 aligned surfaces thus obtained will be cut using a 3D image processing software. A fixed cylinder will extract the PEI from the 4 surfaces. The volume of these 4 PEIs at T0 min, T30 sec, T2 min and T5 min will be calculated using a software"
15914858|NCT03536143|Biological|Topical beremagene geperpavec|Topical gel of non-integrating, replication-incompetent HSV-1 expressing the human collagen VII protein
15914859|NCT03536130|Device|Electronic chest drainage system|Patients in the intervention arm are connected to Drentech Palm Evo with single standard chest tube (28 Ch) immediately after closure of the chest. Patients with digital devices are managed by setting the pump to -20 cmH2O until the morning of postoperative day (POD) 1 and then setting the pump on physiologic mode (0 cmH2O) thereafter. Management of chest tube drainage and decision for chest tube removal will be dictated by clinical signs, symptoms and surgeon preference following standard clinical practice of general thoracic patients
15914860|NCT03536117|Biological|MTBVAC|Live-attenuated Mycobacterium tuberculosis based on the deletion of phoP and fadD26 virulence genes
15914861|NCT03536117|Biological|BCG|Live-attenuated Mycobacterium bovis obtained by subculture passaging in ox-bile and glycerated potatoes between 1908-1921 by Albert Calmette and Camille Guerin. BCG is the only licensed vaccine today against tuberculosis (TB) mainly used in TB-endemic countries.
15914862|NCT03536091|Diagnostic Test|Magnification endoscopy|All IBD patients will undergo magnification endoscopy with 136-fold optical magnification in conjunction with optical chromoendoscopy
15914863|NCT03536078|Other|home phototherapy|
15914864|NCT03536065|Behavioral|Opioid Reduction Intervention|Patient education discharge sheet, nursing education, opioid prescription reduction based on Pre-Intervention data
15914865|NCT03536065|Behavioral|Current Care|Current unchanged care provided; unchanged provider prescribing and unchanged education of patients prior to intervention
15914866|NCT03536052|Device|Virtual Heart Guided Ablation|If a good quality cardiac MRI is obtained and a virtual heart model with the ablation targets is generated, the operating physician will merge the virtual heart lesion map to the invasive electroanatomical navigation system. After the patient has been catheterized, an attempt should be made to induce VT. The physician should then navigate the catheter to each of the ablation targets specified, and place a lesion as per his or her training and experience, confirming when done that the lesion marker in the mapping system coincides with the target. This will be done for each lesion.
15914867|NCT03536039|Drug|NGR-hTNF|dose of 0.8 mcg/sqm
15914868|NCT03536039|Other|RITUXIMAB|dose of 375 mg/mq
15914869|NCT03536039|Drug|Doxorubicin|dose of 50 mg/mq
15914870|NCT03536039|Drug|Cyclophosphamide|dose of 750 mg/mq
15914871|NCT03536039|Drug|Vincristine|dose of 1.4 mg/mq (max 2 mg)
15914872|NCT03536039|Drug|Prednisone|75 mg
15914873|NCT03536026|Procedure|Conventional bronchoscopy|-Standard of care
15914874|NCT03536026|Device|VIDA Pulmonary Workstation 2|-Virtual bronchoscopic navigation system
15914875|NCT03536026|Procedure|Biopsy|-Standard of care
15914876|NCT03536013|Other|Other: Full-thickness placental allograft|A full-thickness placental allograft will be applied to the annulus of the index lumbar level prior to site closure.
15914877|NCT03536000|Diagnostic Test|Fetal echocardiography using the aCMQ-Strain method|Fetal echocardiography using the aCMQ-Strain method (Automated Cardiac Motion Quantification) at 24, 28, 32 and 36 weeks of gestation
15914878|NCT03535987|Device|myocardial PET imaging|using myocardial PET imaging as a means to assess cardiovascular risk in men with prostate cancer planned for androgen-deprivation therapy with external beam radiation therapy
15914879|NCT03535974|Dietary Supplement|Preparation with Spirulina|Preparation with Spirulina to ameliorate the size of benign thyroid nodules
15914880|NCT03535974|Dietary Supplement|Placebo|Placebo administration for 6 weeks bid
15914881|NCT03535961|Drug|apatinib+oral etoposide|apatinib 425/500mg qd, 21days/cycle oral etoposide 50mgmg/m2 d1-10 21days/cycle
15914882|NCT03535935|Drug|Astragalus Powder|"3 grams of water soluble astragalus sachets (equivalent to 15g raw herbs) administrated orally on top of standard medical care for 48 weeks.
~Patients will have 5 days of medicine per week and will be advised to take the medicine once daily dissolved in boiling water in the first 5 days of the week."
15914883|NCT03535935|Other|Routine medical care (active comparator)|Angiotensin converting enzyme inhibitor or angiotensin receptor blocker
15914884|NCT03535922|Other|PROMs Assessment|Routine measurement and reporting of disease-specific PROMs, generic PROMs, or combination of both
15914885|NCT03535909|Diagnostic Test|Noninvasive Hemodynamic Measurement System|Ability of the noninvasive hemodynamic measurement system to determine changes in the hemodynamic status of heart failure patients admitted to the hospital with a primary diagnosis of acute decompensated heart failure.
15914886|NCT03535896|Other|HSR|"Participants will complete a heel raise standing with the forefoot on a step. The toes are maximally dorsiflexed by placing a towel underneath them. The heel raise is performed with a raise to maximal plantar flexion and to maximal dorsi flexion.
~The exercise is performed with a load as heavy as possible but no heavier than 8RM and for as many sets as possible every other day."
15914887|NCT03535896|Drug|Corticosteroid injection|Participants receive an ultrasound-guided corticosteroid injection between 5 and 8 days after baseline. A 21-gauge, 40 mm needle is connected to a 2.5 cm3 syringe filled with 1 ml Triamcinolonhexacetonid (Lederspan, Meda) + 1 ml Lidocain 10 mg7ml (Xylocain, AstraZeneca). The skin is cleansed with Chlorhexidine alcohol 0.5 % (Medic). The needle is inserted with a medial approach under ultrasound-guidance aligned to the long axis of the ultrasound transducer. The injection is placed anterior to the plantar fascia insertion on the calcaneal bone in the region of maximal fascia thickness.
15914888|NCT03535883|Drug|Novel Oral Anti-Coagulants|Novel Oral Anti-Coagulant (NOAC) medications (i.e. Eliquis, Plavix, Xarelto etc.)
15914889|NCT03535870|Drug|Fluticasone propionate/salmeterol|Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the LOMI inhaler device
15914890|NCT03535870|Drug|Advair Diskus, 100 Mcg-50 Mcg Inhalation Powder|Advair (Fixed dose combination of fluticasone propionate and salmeterol xinafoate administered via the Diskus inhaler device)
15914891|NCT03535870|Drug|Placebo|placebo dry powder administered via the LOMI inhaler device
15914892|NCT03535857|Device|PTNS|Use of PTNS on the ankle for 30 minutes
15914893|NCT03535844|Other|Wolfberry|Consumption of cooked dehydrated wolfberry as part of a mixed meal.
15914894|NCT03535844|Other|Healthy diet|Compliance to a healthy diet in accordance to recommendations by the Singapore Health Promotion Board.
15914895|NCT03535831|Diagnostic Test|18F-DCFPyL|The purpose of this study is to determine if use of 18F-DCFPyL would increase the detection of lesions and to better inform your oncologist on the best method of treatment for your disease.
15914896|NCT03535818|Procedure|Radiofrequency ablation|RF application to achieve complete pulmonary vein isolation +/- ganglionated plexus ablation
15914897|NCT03535805|Behavioral|Mind My Mind (MMM)|"Mind My Mind (MMM) is a new transdiagnostic and modular cognitive and behavioural therapy (CBT) program comprising evidence-based interventions for children and adolescents with anxiety, depression or disruptive behavior.
~MMM manual consists of evidence-based CBT methods that are organized into modules. The intervention is tailored to the individual child by the dosing and the sequencing of the modules. Trauma-focused CBT is available. Parents are engaged in child's therapy and support the child in doing the homework. Parent management training is offered for behavioral disturbances. The educational psychologists deliver the therapy after one-week training in the manual, followed by weekly supervision. The treatment fidelity is monitored by video observation of therapy sessions (>20%).
~The MMM training program consists of 9-13 sessions plus one booster, all completed within 17 weeks."
15914898|NCT03535805|Behavioral|Treatment as Usual (TAU)|The parents in the TAU group are offered two sessions (week 2 and week 17) to support their attempts to seek help for the child in the municipality. This coordination is provided by psychologists (or other local professionals) who hold records of the currently available treatment options in the municipality. The TAU vary considerably from no intervention to counselling, talk therapy, pedagogical advice, network meetings, and/or individual support in the school setting. Some children are offered CBT interventions, but access to manualized treatment is generally very limited.
15914899|NCT03535792|Drug|Fentanyl/Hyperbaric bupivacaine|Intrathecal Fentanyl/Hyperbaric bupivacaine and Tibial internal fixation.
15914900|NCT03535792|Drug|Nalbuphine/Hyperbaric bupivacaine|Intrathecal Nalbuphine/Hyperbaric bupivacaine and Tibial internal fixation.
15914901|NCT03535779|Biological|Hepatitis B|The Hepatitis B virus, is a double stranded DNA virus that prevents Hepatitis B in the population
15914902|NCT03535779|Biological|Tetanus Toxoid|The Tetanus vaccine, also known as tetanus toxoid (Td/IVP), is an inactive vaccine used to prevent tetanus in the population
15914903|NCT03535753|Drug|Decitabine and R-GDP|Decitabine and R-GDP
15914905|NCT03535727|Drug|Nab-paclitaxel|IV over 30 minutes; Days 1 and 15
15914906|NCT03535727|Drug|Gemcitabine|IV over 30 minutes; Days 1 and 15
15914907|NCT03535727|Drug|Capecitabine|PO twice daily (BID); Days 1-7, 15-21
15914908|NCT03535727|Drug|Cisplatin|IV over 60 minutes; Days 1 and 15
15914909|NCT03535727|Drug|Irinotecan|IV over 30 minutes; Days 1 and 15
15914910|NCT03535727|Drug|Nab-paclitaxel|IV over 30 minutes; Days 4 and 11
15914911|NCT03535727|Drug|Gemcitabine|IV over 30 minutes; Days 4 and 11
15914912|NCT03535727|Drug|Capecitabine|PO BID; Days 1- 14
15914913|NCT03535727|Drug|Cisplatin|IV over 60 minutes; Days 4 and 11
15914914|NCT03535727|Drug|Irinotecan|IV over 30 minutes; Days 4 and 11
15914915|NCT03535714|Behavioral|MANTR-a treatment|MANTR-a treatment
15914916|NCT03535701|Dietary Supplement|Dietary Intervention|Undergo ketogenic diet
15914917|NCT03535701|Other|Laboratory Biomarker Analysis|Correlative studies
15914918|NCT03535701|Drug|Paclitaxel|Given standard of care therapy with paclitaxel
15914919|NCT03535701|Other|Quality-of-Life Assessment|Ancillary studies
15914920|NCT03535701|Other|Questionnaire Administration|Ancillary studies
15914921|NCT03535688|Drug|D-cycloserine|200 mg BID (twice daily)
15914922|NCT03535688|Drug|Placebo|BID (twice daily)
15914923|NCT03535675|Drug|Muscadine Plus|Ellagic acid inhibits DNA Methyltransferase. DNA Methyltransferases (DNMTs) are a family of enzymes that regulate chromatin methylation and use S-adenosyl methionine (SAM) as the methyl donor. Ellagic acid's metabolite, urolithin-A inhibits the protein complex nuclear factor kappa-light-enhancer of activated B-cells (NFkB), potentially leading to increased rates of apoptosis and decreases in cancer cell proliferation. Extracts from Vitis rotundifolia have shown inhibition of the phosphatidylinositol 3-kinase-Akt pathway.
15914924|NCT03535675|Drug|Placebos|The placebo capsules are rice flour that will be placed in white opaque capsules identical to the ones used for MPX.
15914925|NCT03535662|Drug|Orvepitant|Single oral dose
15914926|NCT03535662|Drug|Itraconazole|Once daily dosing for 10 days
15914927|NCT03535636|Other|Polysomnography|Sleep architecture will be assessed by polysomnography
15915091|NCT03534297|Drug|dapansutrile capsules|Hard opaque capsules containing 100 mg of API.
15914928|NCT03535623|Other|remote ischemic preconditioning (RIPC)|RIPC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of 200 mmHg and 5-min reperfusion.
15914929|NCT03535623|Other|Sham-RIPC|Sham-RIPC consists of 4 cycles of 5-min ischemia using pneumatic cuff pressure of < 10 mmHg and 5-min reperfusion.
15914930|NCT03535610|Device|Uterine Embolization|Uterine Embolization with PVA Microspheres
15914931|NCT03535597|Device|Quikclot Radial Pad|The QuikClot® Radial® pad will be applied over the radial artery access site covered with either a Coban™ bandage or a Tegaderm™ dressing after TRA.
15914932|NCT03535584|Behavioral|Exercise Program|Participants will be asked to complete 2 1-hour exercise sessions per week for 8 weeks (16 total sessions) under the supervision of a licensed respiratory therapist on non-dialysis days. The exercise program will be based on pulmonary rehabilitation and will follow guidelines established by the American Thoracic Society. Exercise sessions will include endurance (treadmill or cycle ergometer), strength (weight resistance), and flexibility training. Exercise sessions will be tailored to individual participants, and participant safety will be monitored during each session.
15914933|NCT03535571|Dietary Supplement|Salmon Protein Hydrolysate|4g of salmon protein hydrolysate per serving.
15914934|NCT03535558|Drug|Fluoroquinolone (FQ)|Participants exposed to an oral FQ will be observed. The oral FQ included are Levofloxacin, Ciprofloxacin, Moxifloxacin, Ofloxacin, Gemifloxacin. Participants will not receive any intervention as a part of this study.
15914935|NCT03535558|Drug|Azithromycin (AZ)|Participants exposed to an oral AZ will be observed. Participants will not receive any intervention as a part of this study.
15914936|NCT03535558|Drug|Sulfamethoxazole/Trimethoprim (ST) Fixed Dose Combination|Participants exposed to an oral ST will be observed. Participants will not receive any intervention as a part of this study.
15914937|NCT03535545|Drug|[68Ga]CBP8|Up to 15 mCi of [68Ga]CBP8 will be administered to each subject.
15914938|NCT03535545|Diagnostic Test|PET Imaging|All subjects will undergo PET imaging after administration of [68Ga]CBP8.
15914939|NCT03535532|Procedure|unilateral laparoscopic adrenalectomy|unilateral laparoscopic adrenalectomy is a kind of minimally invasive surgery commonly operated in patients diagnosed with adrenal diseases with a high likelihood of malignance or surplus hormone secretion.
15914940|NCT03535532|Drug|standard medical treatment|standard medical treatment: detailed medicine strategy chosen for each patient will be associated with their own conditions based on current guidance recommendations.
15914941|NCT03535519|Drug|Methotrexate|standard of care treatment with methotrexate
15914942|NCT03535506|Drug|Palbociclib|Palbociclib capsules for oral administration contain 125 mg, 100 mg, or 75 mg of palbociclib, a kinase inhibitor.
15914943|NCT03535493|Behavioral|Acceptance and Commitment Therapy (ACT)|An ACT session entails a mindfulness-based training to foster and nurture effective behavioral and emotional responding to distress.
15914944|NCT03535493|Behavioral|Float REST|A float session entails laying supine in a light-proof, sound-proof tank consisting of a shallow pool of water (approximately 10 inches set to approximately 94.5 degrees to match skin temperature) with a high concentration of Epsom salt (approximately 1200 pounds) for 60 minutes.
15914945|NCT03535493|Behavioral|ACT + Float REST|The combined intervention will combine ACT and Float REST. An ACT session entails a mindfulness-based training to foster and nurture effective behavioral and emotional responding to distress. A float session entails laying supine in a light-proof, sound-proof tank consisting of a shallow pool of water (approximately 10 inches set to approximately 94.5 degrees to match skin temperature) with a high concentration of Epsom salt (approximately 1200 pounds) for 60 minutes.
15914946|NCT03535480|Drug|G-CSF|G-CSF subcutaneously during five days
15914947|NCT03535480|Combination Product|ASCOT|G-CSF subcutaneously during five days, aphaeresis to hematopoietic stem cell collection and catheterism for ovarian artery infusion
15914948|NCT03535467|Other|Caregiver's Burden Inventory|The Caregiver Burden Inventory was developed by Canadian researchers.The authors of the instrument stress the importance of using a multidimensional measurement of burden with separate scores for each dimension in as opposed to global or uni-dimensional scores.
15914949|NCT03535454|Other|working hours|weekly working hours
15914950|NCT03535428|Diagnostic Test|VENOUS exploration|venous echo doppler ultrasound and abdo pelvic scanner in the 48h before surgery
15914951|NCT03535415|Drug|Recombinant Human Growth Hormone Injection (rhGH)|rhGH 0.05mg/kg/d by subcutaneous injection
15914952|NCT03535402|Drug|Sarilumab|SC administration of 200 mg twice a week
15914953|NCT03535389|Diagnostic Test|Knee 4DCT|Dynamic knee 4DCT
15914954|NCT03535376|Drug|Valsartan|Patients are tested for their normal prescription valsartan medication
15914955|NCT03535363|Drug|Osimertinib|Drug: Osimertinib 80mg or 40mg
15914956|NCT03535350|Drug|Ibrutinib|"Dose response of Ibrutinib. Level 1 starting dose is 420mg daily. Level 2 starting dose is 560mg daily. Level -1 starting dose is 280mg daily.
~November 2020:
~420 mg of ibrutinib plus temozolomide and radiation was found to be safe - up to 36 participants can betreated at the expansion cohort in both arm 1 and arm 2."
15914957|NCT03535350|Radiation|Radiation|2Gy x 30minutes for 6 weeks.
15914958|NCT03535350|Drug|Temozolomide (TMZ)|Cycle 1 150mg/m2 and cycle 2-6 will be up to 200mg/m2.
15914959|NCT03535337|Behavioral|CPS|Assessment of participant's medication adherence and barrier problem solving via phone conversation
15914960|NCT03535337|Behavioral|SMS|Participants will receive a text message, which will be an electronic reminder regarding medication adherence. Participants will then text back a confirmatory response.
15914961|NCT03535324|Behavioral|PROA for optimization|The development of a ASP based on Reinforcement, Guidance and Support Programs, to prescribing physicians for the optimization of antimicrobial use based on a non-tax counseling program and evidence-based recommendations.
15914962|NCT03535324|Other|Control|There will be no intervention
15914963|NCT03535311|Procedure|Measurement of sternal-notch to umbilicus distance|"The sternal notch to upper border of umbilicus length measurement in centimetres.
~The length of the umbilical stump in centimetres.
~The length of the UVC and/or UAC inserted in centimetres which will be identified using the printed markers on the catheter. The marker which is closest to the end of the umbilical stump will be the recorded value.
~The length of the UVC and/or UAC in centimetres when the umbilical stump length is subtracted."
15914964|NCT03535298|Drug|Early Highly Effective Therapies Group|Highly Effective MS Therapy group of medications
15914967|NCT03535272|Drug|Bismuth subsalicylate|We aim to determine if there is a biologic benefit to an intervention (BSS administration) in the acquisition of travelers diarrhea and the acquisition of antimicrobial resistance genes.
15914968|NCT03535272|Drug|Placebo Oral Tablet|Placebo manufactured to mimic pepto bismol
15914969|NCT03535259|Radiation|concurrent sorafenib and IMRT, followed sorafenib maintenance|IMRT 40-60Gy/20-30f; concurrent sorafenib 400mg bid po (it can be given to patients in four weeks before IMRT is applied, so that it can control disease during waiting for IMRT); maintenance sorafenib 400mg bid po until disease progress or unacceptable adverse events; six months is recommended but not mandatory.
15914970|NCT03535246|Biological|Engineered Immune Cells|Engineered immune effector cells (EIE)
15914971|NCT03535233|Drug|Triamcinolone Acetonide|
15914972|NCT03535233|Drug|Minoxidil 5 % Topical Spray|
15914973|NCT03535233|Drug|clobetasol propionate|
15914974|NCT03535220|Combination Product|Protease Inhibitors|Nucleic Acid Synthesis Inhibitors,Hydroxyurea,Antineoplastic Agents
15914975|NCT03535207|Radiation|high dose chemoradiotherapy|"Radiation therapy: 50 Gy at 2 Gy/Fx/d on weeks 1-5,followed by 36 Gy in 30 fractions of 1.2 Gy, twice per day,on weeks 6-8 to a total dose of 86 Gy.
~concurrent chemotherapy: weekly carboplatin area under the curve (AUC) 1.5-2 and paclitaxel 45-50 mg/m2 over the duration (8 weeks) of radiation therapy.
~Adjuvant chemotherapy after high dose chemoradiation is optional."
15914976|NCT03535194|Drug|Mirikizumab|Administered SC
15914977|NCT03535194|Drug|Placebo|Administered SC
15914978|NCT03535194|Drug|Secukinumab|Administered SC
15914979|NCT03535168|Drug|BAY1902607|3 different doses over the course of part 1 and 4 different doses over the course of part 2.
15914980|NCT03535168|Drug|Matching placebo|Matching placebo for BAY1902607
15914981|NCT03535168|Drug|Midazolam|Part 1: The subjects will initially (Day -1) receive a sub-therapeutic dose of 1 mg midazolam as solution in the morning.
15914982|NCT03535142|Procedure|Bariatric surgery|Roux en y gastric bypass or gastric sleeve operation
15914983|NCT03535129|Behavioral|Real time fMRI neurofeedback|During fMRI study, display feedback of brain activity to practice and reinforce control of alcohol craving.
15914984|NCT03535116|Drug|Ketorolac|Toradol is a type of brand name. We will be using the generic version.
15914985|NCT03535116|Drug|Saline|injectable normal saline
15914986|NCT03535103|Drug|Gonal-F®|A single Subcutaneous injection, 225IU
15914987|NCT03535103|Drug|LM001|A single Subcutaneous injection, 225IU
15914988|NCT03535090|Drug|Methylprednisolone|
15914989|NCT03535077|Other|Diagnostic Test|Imaging of the suspicious lesion after application of ORL-1 dye prior to biopsy
15914990|NCT03535064|Other|Hand Hygiene Workshop|Workshops included video-clip and interactive lecture about common infections in schools, methods of transmission, and hand washing procedure and time. Puzzle games related to hand hygiene were distributed among schoolgirls. Posters with cartoon princess picture promote for hand hygiene were also distributed among the schools.
15914991|NCT03535051|Device|fractional carbon dioxide laser|Monthly fractional carbon dioxide laser sessions
15914992|NCT03535051|Drug|Tacrolimus Oint 0.03%|topical daily tacrolimus ointment application
15914993|NCT03535038|Diagnostic Test|Inferior vena cava (IVC) diameter using USG|IVC diameter is measured from the distal of right hepatic pain and inferior vena cava meeting point using Philips En Visor C USG.
15914994|NCT03535038|Diagnostic Test|Vascular pedicle width (VPW)|VPW is measured by drawing a line from the left subclavian artery exit point from aorta perpendicular to the point where superior vena cava crosses with right bronchi.
15914995|NCT03534999|Device|Experimental. This was the group that received TENS|Patients that were on TENS . They were treated twice daily for 5 days. VAS and Hip Score scale were used to assess the pain intensity and disability level
15914996|NCT03534999|Other|No intervention|Patients in this group were on their drugs only. There was no physiotherapy intervention for the patient. VAS and Hip Score scale were used to ascertain the pain intensity and hip disability at the before the treatment and after the treatment
15914997|NCT03534986|Device|International Biophysics AffloVest|High-frequency chest wall oscillation vest
15914998|NCT03534986|Device|Hill-Rom The Vest|High-frequency chest wall oscillation vest
15914999|NCT03534986|Device|Respirtech inCourage|High-frequency chest wall oscillation vest
15915000|NCT03534986|Device|Electromed SmartVest|High-frequency chest wall oscillation vest
15915001|NCT03534973|Other|Caffeine intake|Cataract surgery in eyes with prior caffeine intake
15915002|NCT03534973|Other|No caffeine intake|Cataract surgery in eyes without prior caffeine intake
15915003|NCT03534960|Device|High Flow Nasal Oxygen Therapy|Nasal cannula flows of 3 to 8 lpm via systems approved to provide increased humidification and warmth to inspired gas
15915004|NCT03534960|Device|Nasal CPAP|"Standard nasal CPAP via bubble or ventilator support at levels of 4-8 cm H2O"
15915005|NCT03534947|Drug|Sonidegib|Sonidegib is a selective and orally bioavailable Smoothened (Smo) antagonist. The dose will be 200mg taken once a day for 12 weeks.
15915006|NCT03534947|Drug|Imiquimod|Imiquimod is an immune response modifier that promotes NF-kappa-B-mediated secretion of pro-inflammatory cytokines, chemokines and other mediators. These immune responses produce cytotoxic effects that are antiproliferative and anti-tumour. Imiquimod treatment requires an extended treatment period of 6 weeks for superficial BCC. Imiquimod is an option for the treatment of small, low-risk superficial BCC when surgery, curettage or cryotherapy are inappropriate. Treatment with imiquimod will be for 5 days a week for a total of 6 weeks.
15915007|NCT03534947|Procedure|Surgery|Although most BCCs are amenable to surgery, excision of large tumours in aesthetically sensitive sites may compromise function or cosmesis. Patients whose BCC has not shrunk in size or depth following 12 weeks of sonidegib will undergo surgical excision of the remaining tumour.
15915008|NCT03534947|Other|Best supportive care|Patients with lesions that have progressed in size and/or depth will receive the best supportive care deemed appropriate by the treating clinician. This may be surgery, imiquimod, a clinical trial treatment, radiotherapy or any combination of these interventions
15915009|NCT03534934|Diagnostic Test|Vital signs|"Heart rate, respirations, blood pressure, temperature, oxygen saturation
~arterial oxygen saturation (SaO2), height and weight"
15915010|NCT03534934|Diagnostic Test|Urine Pregnancy Test|Urine pregnancy test done on woman of childbearing potential.
15915012|NCT03534934|Diagnostic Test|Blood Test|Blood test for vitamin D level, Hemoglobin A1c, and creatinine level
15915013|NCT03534934|Diagnostic Test|Duel-energy X-ray absorptiometry scan|Bone density measurement
15915014|NCT03534934|Diagnostic Test|Multi-detector computed tomography|Hip and ankle CT scan
15915015|NCT03534934|Diagnostic Test|Dual-energy X-ray absorptiometry scan|Vertebral fracture assessment
15915016|NCT03534895|Drug|Midazolam Injectable Solution|intravenous
15915017|NCT03534895|Other|Normal saline|intravenous
15915018|NCT03534895|Procedure|Spinal anesthesia|8mg of heavy bupivacaine 0.5% injected in the subarachnoid space, during lateral decubitus
15915019|NCT03534895|Procedure|Surgery|Open inguinal hernia repair, varicose vein stripping, knee arthroscopy or hallux valgus surgery
15915020|NCT03534895|Drug|Postoperative analgesia|IV acetaminophen 1g + IV ketorolac 30mg
15915021|NCT03534895|Drug|Rescue analgesia|Tramadol 2mg/Kg IV in 100mL of normal saline, if pain NRS>3.
15915022|NCT03534895|Drug|Wound infiltration|Wound infiltration with 10mL of ropivacaine 0.75%, in open inguinal hernia repair
15915023|NCT03534895|Drug|Analgesia at home|Oral acetaminophen 1g 6/6h + ibuprofen 400mg 8/8h (+ rescue analgesia with tramadol 50mg 6/6h)
15915024|NCT03534882|Other|Discontinuation of topical prostaglandin analogue therapy|Participants are asked to discontinue their prostaglandin analogue eye drops for the designated time period (42 days)
15915025|NCT03534869|Procedure|Ear acupuncture|French auriculotherapy guidelines - internal genital area, external genital area and Shen Men point.
15915026|NCT03534869|Drug|Analgesics|Oral ibuprofen was given as first line therapy, while oral paracetamol was given as second line therapy.
15915027|NCT03534856|Behavioral|Mindfulness meditation|Short guided mindfulness meditations were provided on an MP3 player.
15915028|NCT03534843|Procedure|Liver resection|Liver resection was comprised of single or multiple liver resections aiming to excise all macroscopic tumors.
15915029|NCT03534843|Other|Transcatheter arterial embolization|Transcatheter arterial embolization or transcatheter arterial chemoembolization can localize the bleeding point and provide interventional embolization.
15915030|NCT03534830|Diagnostic Test|MRI|pre-operative MRI to be performed on all patients and then based on the imaging studies, the patient will be divided into the two comparative cohorts
15915031|NCT03534817|Behavioral|Early Access CR|Participants in the Early Access CR group will begin CR within 1-week post-hospital discharge following their MI, as opposed to Standard Access CR group which begins 7-weeks post-hospital discharge, and the Canadian average (10-14 weeks post-hospital discharge). No further intervention or differentiation between groups is applied; the actual CR program is standardized between groups, and follows the guidelines regularly practiced by the institution.
15915032|NCT03534804|Drug|Cabozantinib|Cabozantinib is administered at 40 mg oral daily
15915033|NCT03534804|Drug|Pembrolizumab|Pembrolizumab will be administered at a fixed dose of 200mg intravenously every 3 weeks.
15915034|NCT03534791|Other|Reminders|Personalized email which will aim for reminding of the translator about the PLSs on hold.
15915035|NCT03534778|Diagnostic Test|Lymph Node Yield (LNY) and Lymph Node Ratio (LNR)|LNY and LNR will be examined after neck dissection
15915036|NCT03534765|Diagnostic Test|CT abdomen +/- pelvis|Diagnostic CT scan (only if requested by responsible clinicians)
15915037|NCT03534765|Diagnostic Test|Edmunton Frailty Score|Patient completed previously valided questionnaire quantifying frailty.
15915038|NCT03534765|Procedure|Emergency laparotomy for general surgical pathology|Emergency general surgical laparotomy (defined by the UK NELA body)
15915039|NCT03534739|Other|Pain Inducing Massage|Participants will receive 60 seconds of manual pressure applied to one myofascial trigger point so the participant rates the pain = 5/10 on a scale from 0 to 10. This will be followed by 30 seconds of complete pressure release. This will occur 4 times.
15915040|NCT03534739|Other|Light Touch Massage|Participants will receive 60 seconds of light touch applied to one myofascial trigger point so the participant rates the pain = 0/10 on a scale from 0 to 10. This will be followed by 30 seconds of complete pressure release. This will occur 4 times.
15915041|NCT03534739|Other|Coldpressor|Participants will place their non-dominant hand into water cooled by a refrigeration unit temperature of 6 degrees Celsius (males) or 8 degrees Celsius (females). The participant will place his or her hand in the cooled water for 60 seconds followed by a 30 second break in which the participant will remove his or her hand from the water. This will occur 4 times.
15915042|NCT03534726|Device|7 T CMR|7 tesla MRI device
15915043|NCT03534713|Drug|Carboplatin|carboplatin aera Under curve 5 on day 1, every 21 days during 3 cycles
15915044|NCT03534713|Drug|Paclitaxel|paclitaxel 175 mg/m² on day 1, every 21 days during 3 cycles
15915045|NCT03534713|Drug|Cisplatin|Cisplatin 40mg/m² given once a week during 5 weeks
15915046|NCT03534713|Radiation|Radiotherapy|45 gray to the pelvis and para aortic area over 5 weeks + intracavitary brachytherapy alone or prior to surgery, depending on response to treatment according to the current guidelines
15915047|NCT03534700|Procedure|parasacral flap reconstruction|parasacral flap reconstruction
15915048|NCT03534700|Procedure|open excision|open excision and healing by secondary intention, marsupialization, excision and primary closure (midline or off-midline), excision and repair by flap.
15915049|NCT03534687|Behavioral|Aerobic Exercise|12-week supervised aerobic exercise
15915050|NCT03534674|Dietary Supplement|vitamin D3|a single oral loading dose of 100,000 IU vitamin D3 on the day of hospital admission for aHSCT, then 2000 IU vitamin D3 daily.
15915051|NCT03534661|Drug|Teduglutide + Normal Saline|Teduglutide 0.05 mg/kg subcutaneous injection; Normal Saline intravenous infusion
15915052|NCT03534661|Drug|Teduglutide + L-NMMA|Teduglutide 0.05 mg/kg subcutaneous injection; L-NMMA 10 mg/kg intravenous infusion
15915053|NCT03534661|Drug|Placebo + L-NMMA|Placebo subcutaneous injection; L-NMMA 10 mg/kg intravenous infusion
15915054|NCT03534648|Drug|PF-06865571 administered Day 7-14|PF-06865571 administered Q12hr on Days 7-14
15915055|NCT03534648|Drug|PF-06865571 administered Day 1-14|PF-06865571 administered Q12hr on Day 7-14
15915056|NCT03534648|Drug|PF-05221304 administered Day 1-14|PF-05221304 administered Q12hr on Days 1-14
15915057|NCT03534648|Drug|PF-05221304 administered Day 7-14|PF-05221304 administered Q12hr Days 7-14
15915058|NCT03534635|Drug|Pembrolizumab|Pembrolizumab monotherapy at 200 mg every 3 weeks for 2 years maximum.
15915059|NCT03534635|Drug|Pembrolizumab - additional treatment|Patients may be retreated for one year of additional pembrolizubmab therapy (200 mg every 3 weeks).
15915060|NCT03534622|Drug|Delafloxacin|In this study, thirty subjects who meet the entry criteria will be assigned to 1 of 5 groups (A, B,C, D, or E) to receive 300 mg delafloxacin IV every 12 hours for a total of 7 doses over 4 days
15915061|NCT03534609|Device|Lutronic Genius System|Treatment of the neck using the Lutronic Genius System
15915062|NCT03534583|Other|Sudarshan Kriya Yoga|Participants in the SKY group will undergo an oline 12-week training course conducted by certified teachers of the Art of Living Foundation
15915063|NCT03534583|Other|Health Enhancement Program|Participants in the online HEP will learn about health promotion, healthy diet, music, and exercise, but will not learn breathing techniques, or meditation. HEP will be delivered by trained staff.
15915064|NCT03534557|Diagnostic Test|FEV6 spirometry|During the same spirometry, to compare the relative value of FVC and FEV6
15915065|NCT03534531|Procedure|Intra-articular cervical zygapophyseal joint injection|Fluoroscopically-guided intra-articular cervical zygapophyseal steroid injection
15915066|NCT03534518|Other|BWS overground training|BWS will be provided with the goal to impose the maximal lower extremity weight bearing load without excessive knee flexion during stance phase and/ or toe dragging during the swing phase. The walking tasks will be roughly divided into different domains like skilled walking, balance, dual tasking, walking speed, walking endurance.
15915067|NCT03534518|Other|BWS treadmill training|Training will be conducted on a standard treadmill with an overhead BWS system that can provide active BWS. Participants are allowed to hold the rails but weight bearing is not allowed. BWS will be provided with the goal to impose the maximal lower extremity weight bearing load without excessive knee flexion during stance phase and/ or toe dragging during the swing phase. Main walking tasks will be endurance (walking long distances at preferred speed) and speed (walking at maximal possible speed).
15915068|NCT03534505|Other|Ketorolac group|patients will undergo herniorrhaphy with Lichtenstein Tension-Free Repair technique. After abdominal sheath will be closed by Vicryl No.0, Patients who are the Ketorolac group will receive local infiltration in abdominal sheath layer with Ketorolac 30 mg in normal saline 10ml. And then skin closure will be done by nylon 3-0.
15915069|NCT03534505|Other|Bupivacaine group|patients will undergo herniorrhaphy with Lichtenstein Tension-Free Repair technique. After abdominal sheath will be closed by Vicryl No.0, Patients who are the Bupivacaine group will receive local infiltration in abdominal sheath layer with 0.5% bupivacaine 10 ml. And then skin closure will be done by nylon 3-0.
15915070|NCT03534492|Drug|Durvalumab|Infusion
15915071|NCT03534492|Drug|Olaparib|P.O.
15915072|NCT03534479|Drug|Polyclonal IgG|Measurement of vascular reactivity before and after Infusion of plyclonal Immunoglobulins G in patients with Common variable immunodeficiency
15915073|NCT03534466|Device|Baby treadmill|The newborns who received treadmill intervention were stimulated by running 3 times a week for a total of 10 minutes each time (complete in 5 cycles, 2 minutes per cycle, 2 minutes after the completion of one cycle and rest for 2 minutes to start the next cycle). Until the completion and completion of the five cycles). During the remaining four days of each week, other physical rehabilitation training is carried out by the rehabilitator in accordance with the established rehabilitation plan. The stimulation of running lasted from 3 months of corrected gestational age to being able to walk alone for 3 steps or to correct for 18 months.
15915074|NCT03534466|Behavioral|Conventional physical rehabilitation training|Suitable for general physical rehabilitation training of all infants with cerebral palsy.
15915075|NCT03534453|Drug|Olaparib 300mg tablets|300mg Olaparib tablets taken orally twice daily until objective radiological disease progression as per RECIST as assessed by the investigator (or as long as in the investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria). Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity.
15915076|NCT03534427|Other|Jump rope exercise intervention|12-week jump rope exercise program
15915077|NCT03534414|Dietary Supplement|Portfolio Dietary Pattern|"Portfolio Dietary Pattern consisting of 4 food components, including:
~plant sterols (sterol-enriched margarine or supplement)
~viscous soluble fibres (oats, barley, psyllium, eggplant, okra, etc)
~plant protein (soy products and pulses), and
~nuts (tree nuts and peanuts)"
15915078|NCT03534414|Dietary Supplement|NCEP Based Diet|A low saturated fat, low cholesterol diet.
15915079|NCT03534401|Behavioral|ARCHES Kenya|ARCHES: FP counselors in intervention clinics will ) provide counseling and education regarding risk of partner detection of FP methods, and women's and girls' strategies to use FP methods to minimize partner detection risk integrated into standard FP counseling, b) make brief inquiries to allow clients the opportunity to disclose experiences of RC and IPV (i.e., screening), c) provide method-specific counseling based on this information and the method chosen by the client, d) provide supported linkage of IPV survivors to local IPV support services (i.e. warm referral), and e) distribute palm-sized educational materials on RC and IPV, as well as IPV services.
15915080|NCT03534388|Other|Sodium Hypochlorite Cleanser|Cleansing with CLn BodyWash
15915082|NCT03534362|Device|Nasopore|Nasopore group will receive frontal drill out procedure as indicated with Kenalog-soaked Nasopore stent applied to the post-operative outflow tract
15915083|NCT03534362|Device|Propel|Propel stent group will receive frontal drill out procedure as indicated followed by Propel stent placement applied to the post-operative outflow tract.
15915084|NCT03534336|Behavioral|Incentive for Education|"A $150 Incentive for Education is given to the participants for passing at least nine quizzes by the end of the program"
15915085|NCT03534336|Behavioral|Incentive for Weight Loss|"A $150 Incentive for Weight Loss is given to the participants for losing at least 5% of baseline weight by the end of the program"
15915086|NCT03534323|Drug|Duvelisib|This drug is designed to stop cancer growth by blocking a protein called phosphatidylinositide 3-kinase (PI3K), which is important for the survival of CLL cells.
15915087|NCT03534323|Drug|Venetoclax|Venetoclax targets a protein called BCL-2, which helps cancer cells survive.
15915088|NCT03534310|Drug|LIRAGLUTIDE 3 Mg/0.5 mL (18 Mg/3 mL) SUB-Q PEN INJECTOR (ML)|
15915089|NCT03534310|Other|lifestyle modification|
15915090|NCT03534310|Other|sleeve gastrectomy|
15945287|NCT03300609|Other|Laboratory Biomarker Analysis|Correlative studies
15915093|NCT03534284|Behavioral|Cognitive Behavioral Therapy for Insomnia|Once weekly treatment sessions for 6 weeks. The content of each of these sessions will be adapted to include changes in behavior during HD treatments (such as napping) and to help patients better adjust to treatment schedules. The CBT-I sessions will be delivered by a therapist face-to-face with the patient via a fully interactive video telehealth platform.
15915094|NCT03534284|Drug|Trazodone|trazodone tablet
15915095|NCT03534284|Drug|Placebo|Inactive pill manufactured to mimic trazodone tablets.
15915096|NCT03534271|Device|iPhone with Kenek Edge and Samsung S8|Smartphones with pulse oximetry and heart rate monitoring capabilities
15915097|NCT03534258|Device|Ceribell Rapid Response EEG, Survey|This trial will qualitatively examine how information from rapid response and conventional EEG data changes physicians' diagnostic suspicion or their treatment decisions and confidence levels. In addition, the results will examine the mean time to EEG lead placement, and ease of use.
15915098|NCT03534219|Device|EarPopper|The EP device is 510(K) regulated (510(K) Number K073401) as a non-surgical, non-drug related treatment for middle ear pressure problems. The device is based on the Politzer Maneuver, and works by opening the Eustachian tube by delivering a safe, constant stream of air into the nasal cavity. In clinical studies funded by the National Institutes of Health (Grant#: 5R44DC003613-03), the EarPopper has proven to be effective in reducing chronic middle ear effusions. By regularly aerating the middle ear, we hypothesize that the EarPopper device will be an effective prophylactic measure to reduce incidence of AOM in children with recurrent OM. The device delivers a jet of air pressure from the nozzle at 5.2PSI, at a volume velocity of 1,524mL/min.
15915099|NCT03534193|Other|Molly Center Diabetes Care Guide (Paper-based)|Diabetes education with Registered Nurse in addition to Paper based education modules
15915100|NCT03534193|Other|Tablet based interactive diabetes education modules|Molly Center Standard Diabetes Education plus access to interactive diabetes education modules through bedside tablet.
15915101|NCT03534180|Other|Laboratory Biomarker Analysis|Correlative studies
15915102|NCT03534180|Drug|Romidepsin|Given IV
15915103|NCT03534180|Drug|Venetoclax|Given PO
15915104|NCT03534167|Behavioral|TODAY! App and Coaching|"The TODAY! app uses the skill building structure of Cognitive Behavior Therapy (CBT). The intervention will be divided into modules, each devoted to a particular skill. Skills addressed within the intervention include increasing social support, engaging in goal-driven behaviors and reducing mood-driven (i.e., avoidance) behaviors, seeking out positive activities, replacing cognitive distortions with more adaptive thinking styles, improving problem-solving skills, reducing avoidance patterns, and increasing alternate coping strategies. The intervention will be supplemented with brief human contact in the form of a motivational coach. The Coach will be trained on the Motivational Interviewing principles upon which the coaching protocol is based."
15915105|NCT03534154|Diagnostic Test|MRI|Magnetic Resonance Imaging
15915106|NCT03534154|Diagnostic Test|Blood Sampling|Sampling of serum
15915107|NCT03534154|Diagnostic Test|Microdialysis|Monitoring of cerebral fluid protein levels
15915108|NCT03534154|Diagnostic Test|Neuropsychological tests|Battery of tests to assess cognitive function, patient outcomes
15915109|NCT03534154|Diagnostic Test|MRI (advanced)|Advanced MRI
15915110|NCT03534141|Device|Esophageal cooling/warming device|The EnsoETM (formerly known as Esophageal Cooling Device) is a non-sterile multilumen silicone tube placed in the esophagus for the purpose of cooling or warming a patient while allowing gastric decompression and drainage. It is placed in a manner identical to a standard orogastric tube, which is standard equipment for liver transplant surgery. It is removed at the end of surgery. Control of the patient's temperature is achieved by connecting the EnsoETM to an external heat exchanger (Gaymar Medi-Therm III or similar system). The Medi-Therm III is a standard device used in operating rooms for warming patients with a conductive table warming pad. The Medi-Therm III circulates temperature-controlled water through a closed-loop system via the two outer lumens of the EnsoETM. Water temperature ranges from 4°C - 42°C.
15915111|NCT03534141|Other|Mild hypothermia|Cooling will be initiated after induction of anesthesia and maintained throughout the anhepatic phase of liver transplantation. In all feasible cases the surgeon will cover the peritoneal surface over the right kidney, which is exposed during the operation, with ice-cold sponges to enhance cooling of the renal parenchyma. After blood flow is completely restored to the liver, the esophageal cooling device and other standard measures (forced-air, fluid, and table warmers, plus a heated anesthesia circuit) will be used to actively re-warm the patient (expected warming rate ≥ 1 deg C/hour). The goal is to achieve normothermia by case end.
15915112|NCT03534141|Other|Normothermia|After induction of anesthesia, the esophageal cooling/warming device and standard warming measures will be used to maintain normothermia throughout the operation.
15915113|NCT03534128|Other|Evaluation of the effect of cues on virtual spatial navigation using a virtual district|Evaluation of the effect of cues on virtual spatial navigation using a virtual district
15915114|NCT03534115|Dietary Supplement|NAC|solution containing NAC
15915115|NCT03534115|Dietary Supplement|Placebo|Placebo
15915116|NCT03534102|Drug|Improved Opioid-Tapering Instructions|Applied to first and second experimental groups in the form of discharge instructions and directions from nursing staff.
15915117|NCT03534102|Behavioral|Clinical Patient Educator|Applied to second experimental group in the form of regular calls about weaning off narcotic medications.
15915118|NCT03534089|Other|Standard infant fomula|Infants with iron deficiency anemia randomly divided into this group were given the same dose of ferralia with other groups,and were fed with infant formula without lactoferrin supplementation.
15915119|NCT03534089|Other|Low level LF infant formula|Infants with iron deficiency anemia randomly divided into this group were given the same dose of ferralia with other groups,and were fed with infant formula supplemented with low level of lactoferrin (38mg/100g).
15915120|NCT03534089|Other|High level LF infant formula|Infants with iron deficiency anemia randomly divided into this group were given the same dose of ferralia with other groups,and were fed with infant formula middle supplemented with high level of lactoferrin (76mg/100g).
15915121|NCT03534076|Other|Cohort Observational study|Cohort Observational study - there is no intervention
15915122|NCT03534063|Genetic|CYP2D6-guided post-operative|For patients randomized to the genotype-guided arm, a saliva or buccal cell sample will be collected unless venipuncture is done for other reasons and then a blood sample will be collected for genotyping.
15915124|NCT03534037|Drug|Febuxostat 40 mg|Febuxostat 40 mg orally per day plus dietary control only
15915125|NCT03534037|Drug|Benzbromarone 50mg|Benzbromarone 50mg orally per day plus dietary control only
15915126|NCT03534037|Other|Control|Dietary control only
15915127|NCT03534024|Dietary Supplement|nanomicielle curcumin|Participants will be selected from those referring to endocrinology clinics of Shohadaye YaftAbad and Pars Hospital (Tehran, Iran) who meet the inclusion criteria. Each subject will give informed written consent to participate in the study. 10 cc fasting blood samples will be collected from each subject at baseline and at the end of trial. Anthropometric parameters will be measured.In order to control the confounding factors in patients, they will be randomly assigned to receive either nanomicelle curcumin or placebo. nanomcelle curcumin and placebo supplements will be provided from the Elixir Nano Sina Company the patients will advise not to change their lifestyle during the study.
15915128|NCT03534024|Dietary Supplement|placebo|Participants will be selected from those referring to endocrinology clinics of Shohadaye YaftAbad and Pars Hospital (Tehran, Iran) who meet the inclusion criteria. Each subject will give informed written consent to participate in the study. 10 cc fasting blood samples will be collected from each subject at baseline and at the end of trial. Anthropometric parameters will be measured.In order to control the confounding factors in patients, they will be randomly assigned to receive either nanomcielle curcumin or placebo. nanomcelle curcumin and placebo supplements will be provided from the Elixir Nano Sina Company the patients will advise not to change their lifestyle during the study.
15915129|NCT03534011|Procedure|Resuscitative Balloon Occlusion of the Aorta|If return of spontaneous circulation (ROSC) is not achieved after advanced cardiac life support (ACLS) is established, a REBOA catheter is inserted via the femoral artery and the aortic balloon inflated, according to a procedure described in a separate document. Ultrasound is used to limit risk related to cannulation and placement of the guidewire.
15915130|NCT03534011|Device|REBOA catheter|Catheter with a Resuscitative Balloon for Occlusion of the Aorta
15915131|NCT03533985|Behavioral|Song of Kin|Music therapists will assess meaningful song/theme (of choice/culture) and provide musical elements in a way that nurtures parents. They will then develop a simplified part of the theme into a soothing lullaby for their infants to be utilized directly by the parent/s and/or the music therapist to comfort, engage or sedate.
15915132|NCT03533985|Other|Gato box|Depending on the time of intervention and need of the infant the music therapist will provide rhythmic entrainment that follows the heart rate or suck patterns of the infant
15915133|NCT03533985|Other|Ocean disc|Depending on the time of intervention and needs of the infant the music therapist will provide a whoosh sound using the Remo Ocean disc. It will be entrained to the infant's respiratory rate.
15915134|NCT03533985|Other|Contingent singing|Depending on the state of the infant, the music therapist will provide short segments of conversant prosody, to enhance quiet-alert, or stimulate relaxation/sleep
15915135|NCT03533985|Other|Tonal Vocal holding|Music therapist will provide a vowel, long held tone, sung without vibrato
15915136|NCT03533985|Other|Muted shaker|If infant is awake, the muted shaker will be used to entrain to the infant's vital signs-to comfort, soothe or sedate
15915137|NCT03533972|Drug|Ashwagandha|ashwagandha capsules given to the subjects twice daily after meals for 1 month
15915138|NCT03533972|Other|Placebo|placebo capsules given twice daily after meals for 1 month
15915139|NCT03533959|Drug|Alirocumab|the administration of Alirocumab at least 75mg every 2 weeks
15915140|NCT03533946|Drug|Rucaparib|Treatment with rucaparib will begin on Cycle 1 Day 1 and continue at 600 mg twice daily. Therapy continues until PSA progression or intolerable toxicities.
15915141|NCT03533933|Device|Collagen matrix|Mucograft collagen matrix combined with coronal advanced flap
15915142|NCT03533933|Other|autologous connective tissue graft|Soft tissue harvesting from patient palate with coronal advanced flap
15915143|NCT03533920|Device|UNI-DEB|Applicate the TACE with UNI-DEB to unresectable hepatocellular carcinoma patient
15915144|NCT03533894|Device|colic capsule|colic polyp diagnosis
15915145|NCT03533881|Dietary Supplement|Arom Digest Slim|"Arom Digest Slim is a dietary supplement approved in Romania by SNPMAPS, with notification number AA 10802/2017.
~It contains: hydrolyzed fish collagen (94,8 %) and volatile oils (5,2 %): Citrus paradisi (2,40 %), Citrus aurantifolia (1,24 %), Menta avensis (0,92 %), Cinamomum zeylanicum (0,56%) Patients take 4 grams of supplement per day; the supplement is dissolved in 750 ml water and drunk throughout the day"
15915146|NCT03533881|Behavioral|Nutritional changes|Education to increase the fruits and vegetables, decrease refined carbohydrates, decrease high fat animal products, regulation of meal programme, increase water intake to at least 1,5 liters per day
15915147|NCT03533868|Diagnostic Test|Point-of-care viral load monitoring test|For enumerating viral load for patients in the POC arm, we will use the Cepheid Xpert® HIV-1 Viral Load test, a quantitative assay with a quantification range of 40 to 10,000,000 copies/mL. Based on the GeneXpert® technology, Xpert HIV-1 VL automates the test process, including RNA extraction, purification, reverse transcription and cDNA real-time quantitation in one fully integrated cartridge. The pre-loaded disposable single-use cartridges provide a visual read-out within 90 minutes. The assay requires 1 mL of plasma using a precision pipette (1.2 mL using a transfer pipette).
15915148|NCT03533855|Diagnostic Test|CS plus FRFSE|"we perform a classic Fast Relaxation Fast Spin Echo (FRFSE) 3D MRI and add compressed sensing sequence"
15915149|NCT03533829|Device|Buzzy®|Buzzy® Drug Free Pain Relief which is a medical device designed to reduce vaccination pain when applied to the arm prior to and during a vaccination.
15915150|NCT03533829|Behavioral|Music|Music will be selected and listened to as a distraction before and during vaccination.
15915151|NCT03533816|Drug|EAGD T-cell infusion (Phase I)|The Alpha Beta (α/β) T-Cell Depletion System utilizes the CliniMACS instrument to yield a gamma delta (γδ) enriched cell therapy product.
15915152|NCT03533816|Drug|EAGD T-cell infusion (Expansion)|The Alpha Beta (α/β) T-Cell Depletion System utilizes the CliniMACS instrument to yield a gamma delta (γδ) enriched cell therapy product.
15915153|NCT03533803|Drug|Indomethacin 100Mg Suppository|Indomethacin 100Mg Suppository will be given 1 to 2 hours before embryo transfer in cases with difficult mock embryo transfer in the active comparator group.
15915154|NCT03533803|Procedure|IVF/ICSI|patients received induction with the long agonist stimulation protocol. Followed by ovum pickup and embryo transfer. Only those with difficult mock embryo transfer will be recruited in this study.
15915155|NCT03533790|Drug|DEP-Ru|"Drug: ruxolitinib
~Drug: doxorubicin
~Drug: etoposide
~Drug: methylprednisolone"
15915156|NCT03533777|Procedure|Peripheral intravenous catheter placement|The region of the upper extremity in which the IV will be placed will be prepped with chlorhexidine and a proximal elastic tourniquet is applied to the upper arm. A 20 gauge 30 millimeter IV catheter is inserted into an upper extremity vein by an anesthesiologist in either an antegrade or retrograde direction depending on which treatment arm the study subject is randomized to.
15915157|NCT03533777|Other|Blood draw|A 20 milliliter(mL) syringe will be connected to the study IV tubing and used to aspirate 20 mL of blood from the study IV catheter. If 20 mL are unable to be aspirated over a 2 minute time frame, a proximal rubber tourniquet will be applied to the upper arm and the blood draw will be reattempted.This will occur twice throughout the study.
15915158|NCT03533777|Device|Peripheral intravenous catheter|A 20 gauge 30 millimeter long BD Insyte(TM) Autoguard(TM) angiocatheter will be used for peripheral intravenous catheter placement as described above.
15915159|NCT03533777|Drug|To keep open (TKO) infusion of 0.9% normal saline|After placement of the peripheral intravenous catheter, an infusion of 0.9% normal saline will be connected to the catheter and infused at a rate of 20 milliliters per hour to keep open (TKO) for future use by preventing blood clot development within the catheter.
15915160|NCT03533764|Behavioral|ASMA|ASMA, grounded in social cognitive theory and utilizing motivational interviewing techniques, guides adolescents in their transition to being consumers and teaching them to navigate the health system, including overcoming challenges to health care access. Briefly, it consists of three complementary components: (1) an 8- week intervention for students; (2) caregiver education; and (3) education for students' medical providers.
15915161|NCT03533751|Biological|etokimab (ANB020)|Humanized Monoclonal Antibody
15915162|NCT03533751|Drug|Placebo|Solution
15915163|NCT03533738|Other|Food sequence 1|Vegetables first then meat & rice together
15915164|NCT03533738|Other|Food sequence 2|Meat first then vegetables & rice together
15915165|NCT03533738|Other|Food sequence 3|Vegetables first then meat followed by rice
15915166|NCT03533738|Other|Food sequence 4|Vegetables first followed by meat and rice together
15915167|NCT03533738|Other|Food sequence 5|Rice first followed by vegetables & meat together
15915168|NCT03533725|Other|Breastfeeding counseling and education services|Breastfeeding counseling and education by educated and trained peer counselors using mHealth tools
15915169|NCT03533712|Dietary Supplement|Fortified balanced energy-protein (BEP) supplement|"The product contains the following target nutrients:
~Total energy: 250-500 kcal per daily serving
~Fat content: 10-60% of energy intake
~Protein content: 16 g (range 14-18 g) with a Digestible Indispensable Amino Acid Score (DIAAS) of ≥ 0.9
~Carbohydrate (CHO) Content: no specific recommendations, relative to fat and protein content.
~Trans Fats: <1% energy intake Micronutrients include the following: A, D, E, K, B1 (thiamin), B2 (riboflavin), B3 (niacin), B6 (pyridoxine), B9 (folate), B12 and C; minerals: iron, zinc, iodine, calcium, phosphorous, copper, and selenium.
~The final composition of macro en micronutrients will be available after the acceptability testing (phase 1) and will be determined by 1) the product type and 2) the preferred taste."
15915170|NCT03533712|Dietary Supplement|Fe and folic acid supplement|Routine iron and folic acid supplementation.
15915171|NCT03533699|Drug|Propranolol|
15915172|NCT03533699|Drug|Placebo Oral Tablet|oral tablets with no active drug
15915173|NCT03533686|Device|Adhear Bone Conduction System|Non-invasive bone conduction hearing device using adhesive
15915174|NCT03533686|Device|Bone anchored hearing aid (BAHA)|Non-invasive bone conduction hearing device using a headband
15915175|NCT03533673|Biological|AAV2/8LSPhGAA|Adeno-associated virus serotype 8 carrying the human GAA gene under the control of the LSP promoter.
15915176|NCT03533660|Behavioral|Feedback|Participant will receive a brief feedback on alcohol use data downloaded from the ABM and information about treatment resources
15915177|NCT03533660|Behavioral|Enhanced Usual Care|Participant will receive information on self reported alcohol use and information about remaining abstinent and about treatment resources
15915178|NCT03533647|Other|Observational|none (observational study)
15915179|NCT03533634|Procedure|Open Reduction Internal Fixation superior plate|3.5mm superior reconstruction plate
15915180|NCT03533634|Procedure|Open Reduction Internal Fixation anteroinferior plate|3.5mm anteroinferior reconstruction plate
15915181|NCT03533621|Dietary Supplement|Probiotic - VSL#3|Subjects received a weekly supply of pills for 12 weeks along with support to change their diet to consume more fruits and vegetables. Subjects met with an interventionist weekly to report on pill consumption, stool changes, and get help with changing their dietary behaviors
15915182|NCT03533621|Dietary Supplement|Placebo pill - soy protein powder|Subjects received a weekly supply of pills for 12 weeks along with support to change their diet to consume more fruits and vegetables. Subjects met with an interventionist weekly to report on pill consumption, stool changes, and get help with changing their dietary behaviors
15915183|NCT03533608|Behavioral|Group PE|Participants will engage in twelve 90-minute sessions of Group PE over the course of 6 weeks. Treatment consists of psychoeducation, rationale for treatment, and in vivo exposure to reduce trauma-related avoidance and thereby improve PTSD symptoms.
15915184|NCT03533595|Device|Barbed|Barbed Suture
15915185|NCT03533582|Drug|Carboplatin|Given IV
15915186|NCT03533582|Drug|Cisplatin|Given IV
15915187|NCT03533582|Drug|Doxorubicin|Given IV
15915188|NCT03533582|Drug|Etoposide|Given IV
15915189|NCT03533582|Drug|Fluorouracil|Given IV
15915190|NCT03533582|Drug|Gemcitabine|Given IV
15915191|NCT03533582|Drug|Irinotecan|Given IV
15915192|NCT03533582|Other|Laboratory Biomarker Analysis|Correlative studies
15915193|NCT03533582|Drug|Oxaliplatin|Given IV
15915194|NCT03533582|Other|Patient Observation|Undergo watchful waiting
15915195|NCT03533582|Drug|Sorafenib|Given PO
15915196|NCT03533582|Drug|Vincristine Sulfate|Given IV
15915197|NCT03533569|Procedure|Intra-articular corticosteroid injection|Participants with arthritis will undergo usual care with knee synovial fluid aspiration followed by intra-articular corticosteroid injection
15915198|NCT03533556|Dietary Supplement|L-theanine|Oral administration of 2.5 mg/kg body weight of L-theanine dissolved in 100 ml of water
15915199|NCT03533556|Dietary Supplement|Caffeine|Oral administration of 2.0 mg/kg body weight of caffeine dissolved in 100 ml of water
15915200|NCT03533556|Dietary Supplement|L-theanine-Caffeine Combination|Oral administration of a combination of 2.5 mg/kg body weight of L-theanine and 2.0 mg/kg body weight of caffeine dissolved in 100 ml of water
15915201|NCT03533556|Other|Placebo|Oral administration of 100 ml of water
15915202|NCT03533543|Device|CEM|All patients with MI hospitalized in the CCU department of Shanghai Tenth People's Hospital will receive 24-hour cardiac monitoring until discharge.
15915203|NCT03533530|Diagnostic Test|Low-density ESI (LD ESI)|Electrical source imaging using low density EEG
15915204|NCT03533530|Diagnostic Test|High-density ESI (HD ESI)|Electrical source imaging using high density EEG
15915205|NCT03533530|Diagnostic Test|No electrical source imaging (ESI)|For all patients: MRI, semiology, visual interpretation of EEG. When needed: PET, SPECT.
15915206|NCT03533517|Device|AccuCinch® Ventricular Restoration|AccuCinch® Ventricular Restoration System in Patients with Heart Failure and Reduced Ejection Fraction (HFrEF)
15915207|NCT03533504|Other|Variability in individual PK|Multivariate hierarchical analysis will be performed on various factors (age, sex, weight, height, dose and type of factor administered (as total and IU/kg), blood group, baseline factor level, positive history of inhibitors, hematocrit, hemoglobin, and serum creatinine, laboratory methods used to measure factor VIII and factor IX) to explore sources of variability in patient outcome.
15915208|NCT03533491|Behavioral|Rewire App|A prototype Rewire app will be designed and created; the first four modules will be evaluated by 60 high-risk adolescents. The teens are asked to complete each module and spend a few minutes each day for two weeks using the practice exercises.
15915209|NCT03533478|Dietary Supplement|Oral treatment Alzer y Diamel|"Alzer:
~Administration way: Oral Dosage: one 500 mg tablet 3 times a day (1500 mg daily) Frequency: after breakfast, lunch and dinner. Duration: one year.
~Diamel:
~Administration way: Oral Dosage: two 660mg capsules 3 times a day (3960 mg daily) Frequency: before breakfast, lunch and dinner. Duration: one year."
15915210|NCT03533478|Dietary Supplement|Placebo|Placebo treatment
15915211|NCT03533465|Behavioral|Complicated Grief Therapy (CGT)|CGT is an evidence based 16 session targeted grief therapy delivered in individual one hour weekly sessions. Treatment will end at 16 sessions (offered over the course of 20 weeks)
15915212|NCT03533452|Drug|Ropivacaine|Local anesthetic injection
15915213|NCT03533452|Drug|Normal saline|Sham injection
15915214|NCT03533439|Diagnostic Test|Near infrared spectroscopy|Four channel measurement of regional haemoglobin oxygen saturation (SO2) in the blood of the bowel, kidney and brain of neonates with gastroschisis during reduction within a silo and after surgery will be performed.• Routine surgical procedure will be followed (clinically indicated silo placement and closure as is currently practised). There will be no change in the clinical practice in place during this pilot study. Clinical management will be as already practiced with the supervision of the consultant with clinical responsibility dictating management
15915215|NCT03533426|Procedure|Serratus anterior plane catheter block|Ultrasonographic guided placement of a catheter under the serratus anterior muscle in cases of open thoracotomies for chest malignancies in an attempt to reduce the emergence of postthoracotomy pain syndrome.
15915216|NCT03533426|Procedure|Patient controlled analgesia|The use of patient controlled analgesia through a pump aiming to reduce the development of postthoracotomy pain syndrome
15915217|NCT03533413|Procedure|combined CT-fluroscopy|Radiofrequency ablation of thoracic dorsal root ganglia guided by combined CT-Fluroscopy
15915218|NCT03533413|Procedure|standard fluroscopy|Radiofrequency ablation of thoracic dorsal root ganglia guided by standard fluroscopy only
15915219|NCT03533400|Device|Jamboxx Respiratory Therapy Device|Jamboxx Respiratory Therapy Device is a novel device that uses interactive gaming to encourage patient compliance with their prescribed respiratory therapy routines. The device consists of a computer game controller with mouthpiece containing a breath flow sensor that connects to a tablet. With the Jamboxx respiratory therapy device, users can choose from a suite of breath controlled respiratory therapy games to guide them through their routines while receiving real-time feedback, and long-term progress tracking.
15915220|NCT03533400|Device|Jamboxx Musical Device|Jamboxx musical device is a hands free, breath controlled music device designed for people with quadriplegia. It resembles a common harmonica in that the user slides a mouthpiece along its horizontal axis to change the pitch of the instrument. The device connects to a personal computer via a mini USB to USB cable to interface with software that provides visual feedback for playing notes and sends the information to the computer speakers. The mouthpiece acts as a transducer, changing air pressure created by the user's lungs to a joystick signal to the computer via a differential pressure sensor. The Jamboxx musical device can produce musical sounds of many instruments (trumpet, drums, etc.) in many different scales and in any key
15915221|NCT03533387|Drug|MN-166|an orally available small molecule drug approved in Japan and Korea for asthma and post-stroke complications and has been prescribed for these indications for more than 25 years
15915222|NCT03533374|Diagnostic Test|Electroencephalogram (EEG) and visual evaluation|Electroencephalogram (EEG) was recorded using Nicolet-One system, and the standard 25-electrode array. Recordings with sharp transients are inspected by experts (physicians).
15915223|NCT03533361|Drug|Lenvatinib|Oral capsules: 4 milligrams (mg) and 10 mg
15915224|NCT03533335|Other|Oral spray (chlorhexidine spray, chlorine dioxide spray, sterile water spray)|Application of a daily dose of 12 sprays (each delivering a volume of 0.13ml) to the buccal and lingual gingival third of tooth surfaces in each sextant
15915225|NCT03533309|Procedure|Computer guided surgical cutting guide|comprised 6 patient undergoing surgical alveolar ridge splitting using computer guided surgical cutting stent
15915226|NCT03533309|Procedure|Conventional alveolar ridge splitting|comprised 6 patient undergoing surgical alveolar ridge splitting using conventional technique.
15915227|NCT03533296|Procedure|Positive end expiratory pressure (PEEP)|The different levels of PEEP, 5 cmH2O, 8 cmH2O and 12 cmH2O, are applied serially. Mean respiratory compliance and intratidal compliance-volume profile are evaluated.
15915234|NCT03533270|Procedure|Urethroplasty|Surgical repair of Urethral injury
15915235|NCT03533257|Drug|AMX0035|Combination Therapy of TUDCA and Sodium Phenylbutyrate
15915236|NCT03533257|Drug|Placebo|Placebo
15915237|NCT03533244|Drug|0.1% AG-86893 Eye Drops|One drop, three times daily to the study eye for 28 days
15915238|NCT03533244|Drug|0.3% AG-86893 Eye Drops|One drop, three times daily to the study eye for 28 days
15915239|NCT03533244|Drug|Vehicle Eye Drops|One drop, three times daily to the study eye for 28 days
15915240|NCT03533231|Combination Product|Canal Disinfection Triple Antibiotic Paste (TAP)|"Patients were treated as follows: Caries was excavated; access cavity was prepared. The rubber dam was then applied and working length was determined. Canal space was irrigated using 40 cc of NaOCl 2.6% solution and final flush of saline. Canal space was dried using paper points. One cc of the prepared paste was injected into the canals using a sterile plastic syringe with 20 gauge needle. The access cavity was then sealed using temporary restoration. After the 3 weeks, anesthesia without vasoconstrictor was administrated. The antibiotic paste was removed and the canal was irrigated using a sterile saline and dried using paper points. Sterile hand file size #25 was introduced into the root canal beyond the working length to induce bleeding. The bleeding was allowed to reach a 3-mm level below the cemento-enamel junction. MTA was used to seal the root canal at the cervical level. After one week, adhesive composite resin was used to seal the access cavity."
15915241|NCT03533231|Combination Product|Ciprofloxacin + Propolis Paste|
15915242|NCT03533231|Combination Product|Ciprofloxacin + Metronidazole Paste|
15915243|NCT03533231|Combination Product|Propolis + Metronidazole paste|
15915244|NCT03533218|Device|Point of care Ultrasound machine|"POCUS methods of assessing ETT location offer an alternative that is time saving and thereby of critical importance in the neonatal time-is-brain scenario. Recently the government of Pakistan began upgrading health facilities and ensuring placement of essential equipment required to provide competent medical care, which may include provision of ultrasound machines to areas where there is established benefits to their use. Presence of trained staff and provision of portable ultrasound machine with short start-up time can save newborn lives(12).POCUS method empowers health care providers to read and interpret images in real time thereby saving critical time and need for specialized human resources (radiologists)."
15915245|NCT03533205|Diagnostic Test|Hypotension Probability Indicator|The accurary of the Hypotension Probability Indicator (HPI) is tested in the created offline database. This means data was prospectively collected but the HPI algorithm was not tested prospectively but after collection in the offline database.
15915246|NCT03533192|Behavioral|It's Your Game...Keep it Real|It's Your Game...Keep it Real consists of 12 50-minute lessons delivered in 7th grade (8 in class and 4 via computer) and 12 50-minute lessons delivered in 8th grade (7 in class and 5 via computer). In each grade, the curriculum integrates group-based classroom activities with personalized journaling and individually tailored computer-based activities. A life-skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal rules regarding risk behaviors, detect signs or situations that might challenge these rules, and use refusal skills and other tactics to protect these rules. The curriculum is grounded in social cognitive theory, the theory of triadic influence, and social influence models.
15915247|NCT03533179|Drug|Glucagon|"Glucagon 1 mg/ml solution is dissolved in 50 ml isotonic fluid and injected as bolus corresponding to 50 micrograms/kg over 1-3 minutes from time=0 on day C+E. on day D (glucagon 2), 50 micrograms/kg of glucagon is infused over 30 minutes from time=0 to time =30."
15915248|NCT03533179|Drug|Esmolol|Esmolol hydrochloride 10 mg/ml is infused from time -15 min to time + 30 minutes as an initial bolus followed by an infusion. infusion rate is tapered if heart rate declines below 30 beats per minute (bpm) or >25 % from baseline, systolic blood pressure decreases below 80 mmHg or the participant experiences side effects.
15915249|NCT03533179|Drug|Physiologic saline - glucagon dummy|Isotonic 0.9 % sodium chloride solution is administered as matching placebo to glucagon, and injected in identical rates on corresponding days.
15915250|NCT03533179|Drug|Physiologic saline - esmolol dummy|Isotonic 0.9 % sodium chloride solution is administered as matching placebo to esmolol, and injected in identical rates on corresponding days.
15915251|NCT03533166|Other|Chlorhexidine|0.03% Chlorhexidine + 0.05% CPC mouth rinse
15915252|NCT03533166|Other|Placebo|Placebo mouth rinse
15915253|NCT03533153|Biological|WJ-MSC cells implantation|Laboratory of Stem Cell of Drum Tower Hospital, Nanjing University Medical School, is able to provide types of Good Manufacture Practice (GMP) level stem cells and stem cell-based medicinal products. Clinical-grade WJ-MSC primary cells are cultured to 4~ 8 passages, and the surface markers (CD90+, CD105+, CD45-, CD31-, CD117-) are identified by flow cytometry. WJ-MSC cells are trypsinized and resuspended in the wash buffer of CTSTMD PBS (+Ca2+, +Mg2+). Within 2 hours after enzyme digestion, WJ-MSC cells are shipped to coronary care unit (CCU) and injected into the body.
15915254|NCT03533153|Drug|CTSTMD PBS without WJ-MSC|For Case-control study only.
15915255|NCT03533153|Drug|Conventional drug therapy|All patients undergo guideline-recommended treatment for STEMI, including aspirin (loading dose of 300mg before maintenance dose of 100 mg/d), clopidogrel (loading dose of 300mg before maintenance dose of 75 mg/d) or Ticagrelor (loading dose of 300mg before maintenance dose of 90 mg/d), angiotensin converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB), β-receptor blockers, statins and nitrate esters.
15915286|NCT03532893|Other|No intervention|This is a multi-center,observational, prospective, cohort study. A total of 10,000 subjects aged 40～75 without history of lung disease will be recruited and followed for 3 years. So there is no intervention in this study.
15915256|NCT03533140|Device|DUCEST Neurostimulator V Group A|The DUCEST Neurostimulator V needle-electrodes are applied post-operatively to stimulate the R.auricularis of the vagus nerve located at the Fossa triangularis. Connecting the needle-electrode cables to the Neurostimulator V activates the device. (The stimulation intensity can be adjusted from 0,05mA to 1,2mA, default value is 0,4mA). The starting stimulation intensity will be adjusted to 1mA and takes place at 1Hz continuously for 40 minutes, followed by a 20 minute break. The built-in 3V battery lasts for approx. 14 days. After 7 days the electrodes are replaced and applied to the other ear of the patient. A plaster with a plastic mounting clip is attached on the shoulder of the patient. The Neurostimulator is connected to the mounting clip. After 14 days or at hospital discharge of the patient, the device is unmounted and the needle-electrodes are removed.
15915257|NCT03533140|Device|DUCEST Neurostimulator V Group B|The DUCEST Neurostimulator V needle-electrodes are applied post-operatively at the Fossa triangularis. Connecting the needle-electrode cables to the Neurostimulator V activates only the signal lamp but not the device.
15915258|NCT03533127|Drug|LY01008|LY01008+Carboplatin/Paclitaxel
15915259|NCT03533127|Drug|Bevacizumab|Bevacizumab + Carboplatin/Paclitaxel
15915260|NCT03533114|Drug|JZP-258|Subjects randomized to JZP-258 will receive the dose taken at the end of the Stable Dose Period.
15915261|NCT03533114|Drug|Placebo Oral Solution|Subjects randomized to Placebo will receive an oral solution at a volume and regimen equivalent to the JZP-258 dose taken at the end of the Stable Dose Period.
15915262|NCT03533101|Drug|Tocilizumab|IL-6 receptor antibody pre-transplant administration to avoid cytokine release syndrome
15915263|NCT03533088|Other|Hospitalized rehabilitation|Patients will recive a rehabilitation prgram at the clinic twice in a week until the post-operative 12. weeks
15915264|NCT03533088|Other|Home-based rehabilitation|Patients will recive a home program once in a two weeks until the 6. weeks of post-operative period. Then will start to recieve a rehabilitation program ar the clinic once in a week auntil the 12. week of the post-operative period.
15915265|NCT03533075|Behavioral|Teachable Moment Brief Intervention|Behavioral intervention informed by Collaborative Assessment and Management of Suicidality and Dialectical Behavior Therapy/Cognitive Behavior Therapy to assist in positive recovery trajectory following a suicide attempt
15915266|NCT03533062|Drug|botulinum toxin A|botox A injection trigonal or trigonal sparing with trial of anticholinergics 6 months post operative for 3 months
15915267|NCT03533049|Other|myFAMI|Patients who are assigned to the myFAMI group will also have the smartphone application downloaded onto either the family member's smartphone or a study-provided smartphone. Following discharge from the hospital, participants will use the smartphone application to answer nine daily questions regarding tracking family coping, transplant symptoms, family management of child transplant symptoms, and family-management difficulty with medication and follow-up regimen daily for the first 30 days following discharge.
15915268|NCT03533036|Device|applied VR headset|Virtual reality (VR) is a three-dimensional experience created by a headset fitted with a video display. The device, designed to be worn on the face, immerses the viewer in a virtual world and can create a visual distraction from the patient's present situation. We will use a commercially available VR device, comprised of a phone and headset. The phone is inserted into the headset to act as the visual display that can create three dimensional environments. The patient will then choose the virtual reality experience she prefers from the two relaxation programs available. The VR device will be introduced to the participant and fitted to her head prior to the procedure. The device is intended to be worn during the full length of the procedure until the conclusion of the D&C, however the participant may decide to stop wearing the device and choose to end the VR experience at any time.
15915269|NCT03533023|Behavioral|Time Restricted Eating + Standard of Care|Participants in this arm will adhere to a daily, consistent 10-hr eating window for the course of the study as well as receive nutritional counseling from the study dietician.
15915270|NCT03533023|Behavioral|Standard of Care|Participants in this arm will receive nutritional counseling from the study dietician, but will not be required to adopt a 10-hr eating window.
15915271|NCT03533010|Dietary Supplement|Ca500mg|subjects receive a daily dose of 500mg elemental calcium
15915272|NCT03533010|Dietary Supplement|VitD800IU|subjects receive a daily dose of 800IU VitD3
15915273|NCT03533010|Other|Placebo|subjects receive placebo tablet
15915274|NCT03532997|Other|ELOS|"The investigators aim to introduce patients with advanced cancer to supportive care resources, including specialty palliative care, through a novel web-based application called ELOS (stands for extra layer of support) in a prospective cohort study."
15915275|NCT03532984|Diagnostic Test|Beam test to predict falls|Dynamic balance will be determined in all participants during beam walking. The beams are 4m long, 2cm high, and 4, 8, and 12cm wide. After a practice trial, participants will perform three trials on each width with and without a calculation task. Trials will be block-randomized based on beam width then on task. Instructions: 'Traverse the entire length of the beam safely at your preferred speed without stepping off, facing forward, with your arms folded in front of your chest. Trials end when you step off, walk sideways, or unfold the arms.' Outcomes are the sum of length traversed, average velocity, number of steps, and average step length determined from video recordings made at 90° relative to the walking direction with full beam length in view using off-the-shelf video cameras.
15915276|NCT03532971|Other|Symptom index questionnaire|A survey administered to identify the symptoms of the patient
15915277|NCT03532971|Diagnostic Test|BK polyomavirus PCR|quantitative PCR testing
15915278|NCT03532971|Other|quality of life questionnaires|Standard questionnaires validated for HCT recipients
15915279|NCT03532958|Drug|BNZ-1|PEGylated peptide inhibitor of IL-2, IL-9, and IL-15
15915280|NCT03532958|Drug|Normal saline|Dose volume consistent with weight-based dosing of BNZ-1
15915281|NCT03532945|Device|Bioactive Glass-Ceramic Spacer|
15915282|NCT03532945|Device|Titanium cage|
15915283|NCT03532919|Diagnostic Test|Serum Tropinin|Blodsamples will be taken 4 times from preoperatively to 2 Days postoperatively
15915284|NCT03532906|Drug|TAP Block|Injection of Bupivacaine 0.5% 20 ml into the thickness of the right abdominal wall and of Bupivacaine 0.5% 10 ml into the surgical wounds.
15915285|NCT03532906|Drug|Control|Injection of Bupivacaine 0.5% 10 ml into the surgical wounds
15915311|NCT03532763|Dietary Supplement|Placebo|1 capsule to be taken twice daily after meals for 6 months. Each capsule contains: Palm olein
15945492|NCT03299088|Biological|Pembrolizumab|Given IV
15915287|NCT03532880|Drug|Olaparib Pill 50 mg|"Olaparib dosing will be twice-daily (BID) dosing. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water.
~Drug administration at the dose level will occur on Day 1 (6 - 9 days prior to start of radiotherapy; for logistical considerations this may occur on the day of simulation for radiotherapy) and will continue concurrently with low dose consolidative thoracic radiotherapy until last day of radiotherapy (Day 20 - 23)"
15915288|NCT03532880|Drug|Olaparib Pill 100 mg|"Olaparib dosing will be twice-daily (BID) dosing. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water.
~Drug administration at the dose level will occur on Day 1 (6 - 9 days prior to start of radiotherapy; for logistical considerations this may occur on the day of simulation for radiotherapy) and will continue concurrently with low dose consolidative thoracic radiotherapy until last day of radiotherapy (Day 20 - 23)"
15915289|NCT03532880|Drug|Olaparib Pill 150 mg|"Olaparib dosing will be twice-daily (BID) dosing. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water.
~Drug administration at the dose level will occur on Day 1 (6 - 9 days prior to start of radiotherapy; for logistical considerations this may occur on the day of simulation for radiotherapy) and will continue concurrently with low dose consolidative thoracic radiotherapy until last day of radiotherapy (Day 20 - 23)"
15915290|NCT03532880|Drug|Olaparib Pill 200 mg|"Olaparib dosing will be twice-daily (BID) dosing. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water.
~Drug administration at the dose level will occur on Day 1 (6 - 9 days prior to start of radiotherapy; for logistical considerations this may occur on the day of simulation for radiotherapy) and will continue concurrently with low dose consolidative thoracic radiotherapy until last day of radiotherapy (Day 20 - 23)"
15915291|NCT03532880|Drug|Olaparib Pill 250 mg|"Olaparib dosing will be twice-daily (BID) dosing. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water.
~Drug administration at the dose level will occur on Day 1 (6 - 9 days prior to start of radiotherapy; for logistical considerations this may occur on the day of simulation for radiotherapy) and will continue concurrently with low dose consolidative thoracic radiotherapy until last day of radiotherapy (Day 20 - 23)"
15915292|NCT03532880|Drug|Olaparib Pill 300 mg|"Olaparib dosing will be twice-daily (BID) dosing. Olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water.
~Drug administration at the dose level will occur on Day 1 (6 - 9 days prior to start of radiotherapy; for logistical considerations this may occur on the day of simulation for radiotherapy) and will continue concurrently with low dose consolidative thoracic radiotherapy until last day of radiotherapy (Day 20 - 23)"
15915293|NCT03532880|Radiation|Radiotherapy|The total prescribed dose will be 30 Gy in ten daily fractions of 3 Gy each delivered during business days over 2 calendar weeks.
15915294|NCT03532867|Other|Examination of pressures before stopping the exercise|"In healthy volunteers performing aerobic physical exercise in the Department of Sports Medicine, the investigators will perform different examinations :
~Macular and peri-papillary OCT in EDI mode (bilateral examination),
~Intraocular pressure (bilateral examination)
~Measurement of systolic and diastolic blood pressure
~Heart rate measurement Exercise testing will be performed on bicycle measuring session with 10 minutes at moderate intensity ( 30% OF MPA), 10 minutes at sustained intensity ( 50% of MPA) and 3 minutes at maximum (70% of MPA).
~The theoretical maximal aerobic power was calculated by a mathematical formula."
15915295|NCT03532867|Other|Examination of pressure during the exercise|"In healthy volunteers performing aerobic physical exercise in the Department of Sports Medicine, the investigators will perform different examinations :
~Macular and peri-papillary OCT in EDI mode (bilateral examination),
~Intraocular pressure (bilateral examination)
~Measurement of systolic and diastolic blood pressure
~Heart rate measurement Exercise testing will be performed on bicycle measuring session with 10 minutes at moderate intensity ( 30% OF MPA), 10 minutes at sustained intensity ( 50% of MPA) and 3 minutes at maximum (70% of MPA).
~The theoretical maximal aerobic power was calculated by a mathematical formula."
15915296|NCT03532867|Other|Examination of pressures after stopping the exercise|"In healthy patients performing aerobic physical exercise in the Department of Sports Medicine, the investigators will perform different examinations :
~Macular and peri-papillary OCT in EDI mode (bilateral examination),
~Intraocular pressure (bilateral examination)
~Measurement of systolic and diastolic blood pressure
~Heart rate measurement Exercise testing will be performed on bicycle measuring session with 10 minutes at moderate intensity ( 30% OF MPA), 10 minutes at sustained intensity ( 50% of MPA) and 3 minutes at maximum (70% of MPA).
~The theoretical maximal aerobic power was calculated by a mathematical formula."
15915297|NCT03532854|Drug|Valsartan|Valsartan P.O
15915298|NCT03532854|Drug|Ezetimibe/Rosuvastatin|Ezetimibe/Rosuvastatin P.O
15915299|NCT03532841|Drug|an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tablet|Group I will receive an oral tramadol 50 mg(Tramal, Memphis, Giza, Egypt) tablet one hour before the procedure.
15915300|NCT03532841|Drug|Placebo Oral Tablet|placebo tablet of the same shape,color and taste will be given in the placebo arm
15915301|NCT03532828|Other|polysomnography|Patients will have a polygraphy, a postural evaluation including Vicon system, EOS imaging, ang a force platform
15915302|NCT03532815|Behavioral|Lifestyle Modification|
15915303|NCT03532802|Drug|Metoprolol Succinate|"week: uptitration with 50 mg capsules per day, until maximum dosage of 150 mg´s/day.
~week: steady state treatment with the maximum tolerated dose of the 1.week."
15915304|NCT03532802|Drug|Placebo oral capsule|"week: uptitration with 1 capsule per day, until maximum tolerated dosage of 3 capsules/day.
~week: steady state treatment with the maximum tolerated dose of the 1. week"
15915305|NCT03532789|Drug|herbal patch|One patch with medicine should be applied to the skin every other day within two weeks
15915306|NCT03532789|Drug|placebo patch|One patch without medicine should be applied to the skin every other day within two weeks
15915307|NCT03532776|Drug|Podofilox Gel 0.5%|Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles
15915308|NCT03532776|Drug|Condylox Topical Gel 0.5%|Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles
15915309|NCT03532776|Drug|Placebo Gel|Apply twice daily for three consecutive days, then discontinuing for four consecutive days, up to four treatment cycles
15915310|NCT03532763|Dietary Supplement|Tocotrienol-rich fraction|1 capsule to be taken twice daily after meals for 6 months. Each capsule contains: 200 mg Tocotrienol-rich fraction
15915312|NCT03532750|Device|Particle|"300-500 µm Embosphere Particles, Merit Medical (Rockland, MA) 501(k) number K991549.
~300-500 µm Embozene Particles, Boston Scientific (Marlborough, MA) 501(k) number K133447.
~Ruby detachable coils, Penumbra (Alameda, CA) 501(K) number K103305.
~Interlock detachable coils, Boston Scientific (Marlborough, MA) 501(k) number K132578."
15915313|NCT03532750|Device|Coil|Ruby or Interlock detachable coils
15915314|NCT03532737|Drug|Pembrolizumab|Adding PD-1 inhibitor to the standard of care
15915315|NCT03532724|Device|Patient Self-Management of VKA therapy|Trained patients check weekly the INR using a portable coagulometer an decide by themselves the dosis of VKA
15915316|NCT03532711|Drug|fluorouracil|chemotherapy treated patients
15915317|NCT03532698|Drug|Aspirin|Aspirin, also known as acetylsalicylic acid (ASA), is a very safe medication used to treat pain, fever, or inflammation.
15915318|NCT03532698|Drug|Osimertinib|Osimertinib, also known as azd9291, is a 3rd-generation EGFR-TKI used to treat NSCLC patients with resistance to 1st generation EGFR-TKI due to T790M mutation. It has been approved in clinical applications by the FDA in 2015.
15915319|NCT03532685|Procedure|Bariatric|withdrawing a part of the stomach and may or may not be combined with bowel deviation
15915320|NCT03532672|Other|Acute Fasting|The volunteers will fast overnight (10 hours) and breakfast will be offered (bread, butter, ham and industrialized fruit juice) and the participants will fast for more 10 hours during daily activities.
15915321|NCT03532659|Other|Active video game|Among the 20 municipal schools, two will be selected between those with 298 or more students (corresponding to the third quartile of the number of students per school). Next will be selected the school in which the adolescents will be submitted to intervention, and the students from the other school will be control. The intervention will aim to promote physical exercise through active video game XBOX 360 with Kinect. The game selected will be Just Dance, to allow the participation of up to four students at the same time. In addition, a gamification protocol will be performed to increase the adolescents engagement in the exercise.
15915322|NCT03532646|Procedure|upper endoscopy|endoscopy of the gastrointestinal tract
15915323|NCT03532633|Procedure|cord blood|collection of cord blood
15915324|NCT03532633|Procedure|blood sample infant|collection of remnant of clinically indicated blood sample
15915325|NCT03532633|Procedure|blood sample mother|collection of remnant of clinically indicated blood sample. If not available blood sample is taken after mother agreed
15915326|NCT03532633|Procedure|breast milk|collection of breast milk 1/week during neonatal care (maximum 8 weaks)
15915327|NCT03532620|Drug|Pitavastatin Calcium|"In Pitavastatin treatment group, Pitavastatin calcium tablet 2mg/day was given for 12 months in combination with lifestyle modification. But month 3 is the check point. If LDL-C target was achieved at Month 3, doses remained the same. If LDL-C target was not achieved at Month 3, doses were doubled."
15915328|NCT03532620|Drug|Atorvastatin Calcium|"In Atorvastatin treatment group, Atorvastatin calcium tablet 20mg/day was given for 12 months in combination with lifestyle modification. But month 3 is the check point. If LDL-C target was achieved at Month 3, doses remained the same. If LDL-C target was not achieved at Month 3, doses were doubled."
15915329|NCT03532607|Other|Music|Patients will listen to soothing music for 30 minutes before their standard of care botox injection
15915330|NCT03532594|Procedure|PRODOSE Algorithm|Protamine administered according to PRODOSE algorithm
15915331|NCT03532594|Procedure|Standard Care|Protamine administered according to Standard Care
15915332|NCT03532581|Other|Indocyanine Green Solution|Given Subcutaneous injection
15915333|NCT03532581|Procedure|Lymphangiography|Undergo lymphangiography
15915334|NCT03532568|Other|skin biopsy|4mm punch skin biopsy
15915335|NCT03532568|Radiation|narrowband ultraviolet B|narrowband ultraviolet B for CKD-aP patients
15915336|NCT03532555|Dietary Supplement|Zinc Acetate|Zinc Acetate given with elemental zinc dose of 2mg/kg given orally only daily through 35 6/7 weeks corrected gestational age
15915337|NCT03532555|Other|No supplemental zinc|Infants will receive standard of care, which is currently no supplemental zinc
15915338|NCT03532542|Drug|Casimersen|Casimersen solution for IV infusion
15915339|NCT03532542|Drug|Golodirsen|Golodirsen solution for IV infusion
15915340|NCT03532529|Other|not applicable, it is an observational study|not applicable, it is an observational study
15915341|NCT03532516|Drug|Brivaracetam|"Patients will start on the individual Brivaracetam (BRV) dose that they had reached at the completion of the previous study. The BRV dose can be adjusted based on the individual patient's seizure control and tolerability; however, the BRV dose may not exceed 200 mg/day in divided (preferably symmetrical) morning and evening doses, taken with or without food.
~Up- and down-titration steps should be performed in steps of maximum 50 mg/day on a weekly basis. The full down-titration should include a 1-week step at 20 mg/day."
15915342|NCT03532503|Device|Foley catheter|Transcervical foley catheter will be applied
15915343|NCT03532490|Drug|Roflumilast 500 Mcg Oral Tablet|The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day.
15915344|NCT03532490|Drug|Placebo oral capsule|The first two weeks the participant will take one tablet every other day. If well tolerated, participant will take one tablet every day.
15915345|NCT03532477|Drug|Venlafaxine|Patients are tested for their normal prescription metaprolol medication
15915346|NCT03532464|Drug|azithromycin|The route of administration is oral. It is administered at a dose of 1 g (4 tablets), as a single dose with or without food.
15915347|NCT03532464|Drug|doxycycline|The patients in the doxycycline group take one tablet of 100 mg twice a day for seven days.
15915348|NCT03532451|Drug|Nivolumab|Nivolumab 480 mg intravenously (IV) over approximately 30 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion.
15915349|NCT03532451|Drug|Nivolumab/Lirilumab|Nivolumab 480 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) with at least a 30 minute rest between infusions followed by lirilumab 240 mg IV over approximately 60 minutes every 4 weeks for 2 neo-adjuvant doses (week 0 and 4) followed by RC with bilateral (standard or extended) PLND as soon as possible but within 6 weeks after the last neoadjuvant infusion.
15915350|NCT03532425|Drug|B/F/TAF|B/F/TAF (Bictegravir 50mg/ Emtricitabine 200mg/ Tenofovir Alafenamide 25mg) Tablet taken orally once daily
15915351|NCT03532425|Drug|Atripla|Atripla (Efavirenz 600mg/ emtricitabine 200 mg/ tenofovir disoproxil 245 mg) Tablet taken orally once daily
15915352|NCT03532425|Drug|B/F/TAF Placebo|Tablet taken orally once daily
15915353|NCT03532425|Drug|Atripla Placebo|Tablet taken orally once daily
15915354|NCT03532399|Drug|Bivalirudin|"CPB: Per hospital protocol, bivalirudin 1 mg/kg IV will be administered to the patient 10 minutes prior to the start of CPB along with an infusion of bivalirudin at 2.5 mg/kg/hr. Additional bolus doses of 0.5 to 1 mg/kg will be administered for ACTs less than the specified target (either 2 times baseline ACT or > 400 seconds per the discretion of the patient's providers). 50mg of bivalirudin will be administered to the bypass circuit.
~Cardiac Catheterization: Bivalirudin will be administered to the patient as 0.75mg/kg IV bolus followed by a 1.75mg/kg/hr infusion for the length of the procedure. Changes in infusion rate or bolus dosing during the procedure and post-procedure will be at the discretion of the patient's care providers.
~ECMO/VAD: Dosing will be informed by the hospital's formulary recommendations(http://online.lexi.com/lco/action/doc/retrieve/docid/chibos_f/6317841), but will ultimately be determined by patient's primary provider."
15915355|NCT03532386|Procedure|ICSI|ICSI for both couples
15915356|NCT03532373|Other|Preference Elicitation tool|A preference elicitation tool for carpal tunnel syndrome
15915357|NCT03532360|Other|Oral immunotherapy|Starting from a very low level and over a period of several months, participants receive escalating doses of the food to which they are allergic
15915358|NCT03532347|Device|EUS-FNA needle (Beacon)|Participants will be randomised to an initial 3 passes with Beacon FNA and then Beacon SharkCore biopsy needles or vice versa. 25g needles will be used for trans duodenal puncture and 22g for trans gastric puncture.
15915359|NCT03532334|Diagnostic Test|Perfluorinated Gas/Oxygen Mixture|19-Fluorine (19F) MRI of the lungs with 21%/79% Oxygen/Perfluorinated Gas, ≤ 25 liters, gas, single visit, < 1 hour
15915360|NCT03532321|Other|NA : non interventional study|NA : non interventional study
15915361|NCT03532308|Drug|Fermented Soy|Two 12.5g packets/day) (~1 ounce/day) taken between the time of enrollment and radical prostatectomy (RP). Time can be between 4 and 10 weeks.
15915362|NCT03532308|Other|Placebo|A placebo compliment to the active intervention with identical packaging and labeling will be used.
15915367|NCT03532282|Behavioral|ONLINE ONLY|Access to an online cognitive behavioral therapy for insomnia
15915368|NCT03532282|Behavioral|STEPPED CARE|A two step treatment that starts with either an online or therapist led cognitive behavioral therapy for insomnia, depending on a decision algorithm. Those with insufficient progress to the online treatment after 8 weeks are switched to a therapist-led treatment
15915369|NCT03532269|Device|Nightly App|The Nightly application will be installed independently on the user's smartphone. Once the user has set up their account and has logged in, they can then perform regular sleep quality assessments. In order to record a measurement, the user must first select a film (first screen) and watch it (second screen), the visualizations and acoustics aid in the process of falling asleep. After the film finishes, the participant places the phone on the corner of the bed, firstly with the screen facing up, and then under his/her pillow. Throughout the night, the application registers sleep phases that will be analyzed later.
15915370|NCT03532256|Behavioral|Observation|Patients will be contacted postoperatively via an automated text-message to assess pain, functional status, and opioid consumption.
15915371|NCT03532256|Behavioral|Text to online survey|Subset of surgical patients will receive an automated text message with a link to a secure online survey with questions that assess pain, functional status, and opioid consumption.
15915372|NCT03532256|Behavioral|Bi-directional text script|Subset of surgical patients will receive an automated bi-directional text message script with questions that assess pain, functional status, and opioid consumption.
15915373|NCT03532243|Procedure|incremental inspiratory load|inspiratory load ranges between 10 and 40 cm water column (cmH2O)or intolerable to the patient, each load increment for 5cm water column.
15915374|NCT03532230|Procedure|Osteopathic Manipulative Treatment (OMT)|No specific OMT techniques will be required for the present study. However, data on the number of OMT sessions patients receive will be collected.
15915375|NCT03532217|Biological|PROSTVAC-V|-Replication-competent vaccinia virus which has been engineered to encode the sequences for a modified human prostate-specific antigen (PSA) and a triad of co-stimulatory molecules (TRICOM)
15915376|NCT03532217|Biological|PROSTVAC-F|-Fowlpox virus which does not replicate in human cells and has been engineered to encode the same sequences present in PROSTVAC-V.
15915377|NCT03532217|Drug|Nivolumab|-Nivolumab is a human monoclonal antibody (mAb)
15915378|NCT03532217|Drug|Ipilimumab|-Ipilimumab is a mAb blocking the inhibitory signal mediated by cytotoxic T Lymphocyte-associated antigen 4 (CTLA-4), a protein receptor that downregulates the immune system.
15915379|NCT03532217|Biological|Neoantigen DNA vaccine|Each DNA vaccination will be 1 mL vaccine administered intramuscularly. At each vaccination time point, patients will receive two injections at separate sites.
15915380|NCT03532217|Device|TriGrid Delivery System|-Electroporation device
15915381|NCT03532217|Procedure|Tumor biopsy|-Pre-treatment, post-treatment A (optional), and end of treatment
15915382|NCT03532217|Procedure|Peripheral blood|-At the time of pre-treatment biopsy, mid-treatment of chemo-ADT, at time of enrollment (prior to POSTVAC administration), mid-treatment A, mid-treatment B (multiple)
15915383|NCT03532217|Procedure|Fecal samples|-Post chemo/pre-treatment A, post-treatment A, pre-treatment B, post-treatment B
15915384|NCT03532217|Procedure|Leukapheresis|"Post-treatment A/pre-treatment B
~Mid-Treatment B, after Cycle 9 Day 1 and prior to Cycle 10 Day 1
~End of treatment"
15915385|NCT03532204|Radiation|SBRT|"Patients will received 2 courses of chemotherapy before SBRT if no hepatic or extra-hepatic progression identified.
~All liver metastases will be irradiated. 4 doses prescription are allowed (according to the center, and the technique uded and the dosimetric constraints): 3x15 Gy, 4 x 15 Gy, 5 x10 Gy or 5 x 8 Gy.
~The remaining courses of chemotherapy 2 to 3 weeks after completion of SBRT will be administered"
15915386|NCT03532204|Drug|Chemotherapy|At investigator's discretion
15915387|NCT03532191|Other|PrEP Optimization Intervention (PrEP-OI)|PrEP-Rx + PrEP Coordinator
15915388|NCT03532178|Drug|"Group A. Muscle relaxant #1: rocuronium + sugammadex; Muscle relaxant #2: succinylcholine +saline"|"The participants will be randomized to start with Muscle relaxant #1 in the first study treatment, and will switch to Muscle relaxant #2 in the second study treatment period."
15915389|NCT03532178|Drug|"Group B. Muscle relaxant #2: succinylcholine +saline; Muscle relaxant #1: rocuronium + sugammadex;"|"The participants will be randomized to start with Muscle relaxant #2 in the first study treatment, and will switch to Muscle relaxant #1 in the second study treatment period."
15915390|NCT03532165|Diagnostic Test|Lower extremity Ultrasound|One group may forego a CT angiogram of the chest if they have a positive lower extremity ultrasound. The other group with a negative ultrasound may still require CT angiogram imaging.
15915391|NCT03532152|Device|Pure Purr VR technology|"The Pure Purr technology consists of BoboVR X1 headset with pre-installed software. The virtual reality headset reproduces a dynamic video content that is visually perceived with the help of the high-resolution screen. Also, the headset is able to play audio and transmit it via the headphones.
~The audio sequence has been modified by adding a binaural effect and has been synchronized with the tact of respiratory movements and the frequency of heart rate."
15915392|NCT03532152|Device|Sham VR technology|The sham technology includes an identical BoboVR X1 virtual reality headset with pre-installed software. The audio-visual sequence is similar to the one in the investigational version of the software. The key difference is that the audio sequence has not been modified with the binaural effect and has not been synchronized with the tact of respiratory movements and the frequency of heart rate.
15915393|NCT03532139|Drug|Enoxaparin|Enoxaparin is used for prevention of blood clots following abdominal or orthopedic surgery and in medical patients with restricted mobility during acute illness
15915394|NCT03532139|Drug|Enoxaparin + Rosuvastatin|"Rosuvastatin is an anti-cholesterol medication that is FDA (the U.S. Food and Drug Administration) approved to lower cholesterol and reduce the risk of arterial blood clots. There is evidence that rosuvastatin can lower the risk of venous blood clots in healthy individuals
~Enoxaparin is used for prevention of blood clots following abdominal or orthopedic surgery and in medical patients with restricted mobility during acute illness"
15915395|NCT03532139|Other|Thromboprophylaxis|standard of care therapy
15915396|NCT03532126|Device|Dermal filler for midface deficit|During this procedure the device (a dermal filler) will be deep intradermal, subcutaneous or supraperiosteal injected according to its CE mark.
15915397|NCT03532113|Behavioral|Updating|Updating is trained across 12 sessions using N-back-type exercises. Training is performed on a samsung galaxy tab2. Each session lasts 30 minutes. The difficult is reset and the nature of the stimuli (numbers vs. symbols) is changed halfway in each session.
15915398|NCT03532113|Behavioral|Inhibition|Inhibition is trained across 12 sessions with Stroop-like exercises. Training is performed on a samsung galaxy tab2. Each session lasts 30 minutes. The difficult is reset and the nature of stimuli (letters vs. numbers) is changed halfway in each session.
15915399|NCT03532113|Behavioral|General knowledge|General Knowledge is trained across 12 sessions. Participants complete four-choice questions relating to general knowledge and vocabulary and are provided with the correct answer and a short explanation. Questions are displayed one by one on a computer screen with a maximum of 20 seconds per question. Each session lasts 30 minutes and includes 2 blocks of 40 new questions each (about 220 seconds per block). Questions with wrong answers are displayed again at the end of each block.
15915400|NCT03532100|Device|Torsionally adaptive prosthesis with 0:1 coupling ratio|The torsionally adaptive prosthesis can be programmed to couple the motion between the transverse- and sagittal-planes. A coupling ratio (transverse:sagittal) of 0:1 means there will be no coupling between the transverse- and sagittal-plane motion. That is, regardless of any motion in the sagittal plane, there will be zero motion in the transverse plane.
15915401|NCT03532100|Device|Torsionally adaptive prosthesis with 1:6 coupling ratio|The torsionally adaptive prosthesis can be programmed to couple the motion between the transverse- and sagittal-planes. A coupling ratio (transverse:sagittal) of 1:6 means there will be one degree of motion in the transverse plane for every six degrees of motion in the sagittal plane.
15915402|NCT03532100|Device|Torsionally adaptive prosthesis with 1:4 coupling ratio|The torsionally adaptive prosthesis can be programmed to couple the motion between the transverse- and sagittal-planes. A coupling ratio (transverse:sagittal) of 1:4 means there will be one degree of motion in the transverse plane for every four degrees of motion in the sagittal plane.
15915403|NCT03532100|Device|Torsionally adaptive prosthesis with 1:3 coupling ratio|The torsionally adaptive prosthesis can be programmed to couple the motion between the transverse- and sagittal-planes. A coupling ratio (transverse:sagittal) of 1:3 means there will be one degree of motion in the transverse plane for every three degrees of motion in the sagittal plane.
15915404|NCT03532100|Device|Torsionally adaptive prosthesis with 1:2 coupling ratio|The torsionally adaptive prosthesis can be programmed to couple the motion between the transverse- and sagittal-planes. A coupling ratio (transverse:sagittal) of 1:2 means there will be one degree of motion in the transverse plane for every two degrees of motion in the sagittal plane.
15915405|NCT03532087|Drug|Denosumab 120 mg|Denosumab 120 mg every 3 weeks.
15915406|NCT03532087|Drug|Denosumab 60 mg|Denosumab 60 mg every 6 months.
15915407|NCT03532074|Diagnostic Test|assessment of bowel symptoms before surgery|validated questionnaires (Knowles-Eccersley-Scott-Symptom Questionnaire and Gastrointestinal Quality of Life Index) are filled in by patients with rectosigmoid endometriosis before surgery
15915446|NCT03531827|Drug|enzalutamide|enzalutamide is an AR antagonist that is standard care therapy for metastatic prostate cancer
15945493|NCT03299088|Drug|Trametinib|Given PO
15915408|NCT03532074|Diagnostic Test|assessment of rectosigmoid during laparoscopy|indocyanine green (0.25 mg/kg) is administered through peripheral line. A near-infrared camera-head (KARL STORZ Gesellschaft mit beschränkter Haftung & Co., Tuttlingen, Germany) is used to visualize bowel perfusion before and after the removal of the rectosigmoid nodule. To estimate the vascularization, a scale with a score between 0 and 4 is used
15915409|NCT03532074|Diagnostic Test|follow up and assessment of bowel symptoms after surgery|validated questionnaires (Knowles-Eccersley-Scott-Symptom Questionnaire and Gastrointestinal Quality of Life Index) are filled in by patients with rectosigmoid endometriosis after surgery
15915410|NCT03532074|Diagnostic Test|assessment of rectosigmoid perfusion during robot-assisted laparoscopy|indocyanine green (0.25 mg/kg) is administered through peripheral line. The robotic Firefly imaging system (daVinciXi surgical platform; Intuitive Surgical, Sunnyvale, CA) is used to visualize bowel perfusion before and after the removal of the rectosigmoid nodule. To estimate the vascularization, a scale with a score between 0 and 4 is used
15915411|NCT03532061|Behavioral|FamCare Program|6 in-person sessions of biweekly home care problem-solving skills training (FamCare) delivered by a health educator.
15915412|NCT03532061|Other|Caregiver Support Group|6 in-person caregiver support group sessions held biweekly and moderated by a health educator.
15915413|NCT03532048|Behavioral|The Papás Saludables, Niños Saludables Program|Papás Saludables, Niños Saludables is a 10 week program for fathers and their children that meets weekly. Each session is 90 minutes long: 15 min introduction, 30 min pull-out sessions for fathers and children, and 45 min active play sessions together. Fathers are encouraged to improve their eating and physical behaviors to lose weight and to be healthy role models for their child. Children are encouraged to help their fathers lose weight and improve their health. The program has been adapted to contextualize the information for low-income Hispanic families and changed to US food and physical activity guidelines. Mothers will be provided a Handbook and will be sent short videos, recipe links, and short motivational messages every week covering the same topics as in the sessions.
15915414|NCT03532048|Behavioral|The Papás Saludables, Niños Saludables Wait-list Control|The same program as above delivered to the wait-list control after the T1 follow-up data has been collected.
15915415|NCT03532035|Drug|Brincidofovir|Subjects will receive BCV administered as a continuous IV infusion over 2 hours twice weekly (on Days 1, 4, 8, and 11) for a period of 2 weeks (total of 4 doses).
15915416|NCT03532035|Drug|Standard of Care|"Subjects randomized to the SoC in each cohort will be managed per local institutional guidelines and investigator judgement. SoC treatment options may include, but are not limited to, taking a watch and-wait approach, with or without decreased immunosuppression (i.e., no active treatment), or treatment with IV CDV, ganciclovir, or ribavirin."
15915417|NCT03532022|Drug|Chronocort®|Hydrocortisone modified release capsules - 5mg, 10mg and 20mg.
15915418|NCT03532022|Drug|Standard Care|The subject's standard care regimen upon entering the study; this could consist of hydrocortisone, dexamethasone, prednisone or prednisolone.
15915419|NCT03532009|Drug|Sodium Zirconium Cyclosilicate|Oral use for approximately 3 months
15915420|NCT03532009|Drug|Placebo|Oral use for approximately 3 months
15915421|NCT03531983|Procedure|fixation of tochentric fractures by gamma nail|• Thirty patients with recent traumatic extracapsular proximal femoral fractures were treated using a short gamma nail of third-generation assembly
15915422|NCT03531970|Drug|2% lidocaine with 1:80,000 epinephrine|Anesthetic solution
15915423|NCT03531970|Drug|Dexamethasone|Corticostroide
15915424|NCT03531970|Drug|Placebo|Placebo
15915425|NCT03531957|Drug|ASN002|Daily dose of ASN002 for 12 weeks
15915426|NCT03531957|Drug|Placebo Oral Tablet|Placebo of ASN002 for 12 weeks
15915427|NCT03531944|Other|Community pharmacist-involved collaborative care|Community pharmacist-involved collaborative care in the management of individuals with type 2 diabetes mellitus
15915428|NCT03531944|Other|Usual care|Usual care with physician and as needed visit to the nurse
15915429|NCT03531931|Drug|Apatinib/Capecitatine|Apatinib is a tyrosine kinase inhibitor that selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR2), now being developed by Jiangsu Hengrui Medicine (China). Even at a low concentration apatinib can still perform magnificent VEGFR2 inhibitory activities, meanwhile at little higher concentration it can inhibit PDGFR and kinases as well, such as c-Kit and c-Src .The action sites of apatinib are the intracellular ATP binding site of the protein tyrosine receptor. Pharmacodynamical study shows that apatinib is able to inhibit the tyrosine kinase activity of VEGFR, block signal conduction after the combination of VEGF, finally contribute to stopping new blood vessel formation in tumor tissue.
15915430|NCT03531918|Drug|Cladribine|Given IV
15915431|NCT03531918|Drug|Cytarabine|Given IV
15915432|NCT03531918|Drug|Gemtuzumab Ozogamicin|Given IV
15915433|NCT03531918|Biological|Recombinant Granulocyte Colony-Stimulating Factor|Given SC
15915434|NCT03531918|Other|Laboratory Biomarker Analysis|Correlative studies
15915435|NCT03531918|Drug|Mitoxantrone Hydrochloride|Given IV
15915436|NCT03531905|Drug|Bempedoic acid + Ezetimibe FDC Oral Tablet|Experimental therapy of bempedoic acid 180 mg + ezetimibe 10 mg FDC tablet
15915437|NCT03531905|Drug|Ezetimibe 10 mg Oral Tablet|Ezetimibe 10 mg tablet, overencapsulated for blinding purposes
15915438|NCT03531905|Drug|Placebo Oral Tablet|Placebo tablet, matched for the FDC product for blinding purposes
15915439|NCT03531905|Drug|Placebo oral capsule|Placebo over-encapsulated for blinding purposes
15915440|NCT03531892|Drug|AJM300|AJM300 film-coated tablets.
15915441|NCT03531892|Drug|Placebo|Placebo matched to AJM300 tablets.
15915442|NCT03531866|Behavioral|DigiKnowIt News|DigiKnowIt News is an online, interactive, multimedia web-based resource designed to educate youth about participating in clinical trials. Youth will learn general information about clinical trials, their rights in a clinical trial, the good and not so good of participating in clinical trials, communication with others during a clinical trial, and specific types of procedures used in clinical trials (i.e., needles, scans). DigiKnowIt News is web-based and youth can complete it at home, on their own time.
15915444|NCT03531840|Drug|Olaparib|All subjects will take olaparib by mouth twice per day until disease progression or unacceptable toxicity
15915445|NCT03531840|Device|ClinOmics|Non-significant risk (NSR) device
15915447|NCT03531827|Drug|CRLX101|CRLX101 is a nanoparticle-drug conjugate (NDC) comprised of a linear cyclodextrin-polyethylene glycol-base polymer conjugated to multiple 2 (S)-camptothecin (CPT) molecules (Poly-CD-PEG-Camptothecin)
15915448|NCT03531814|Behavioral|Medication Event Monitoring System (MEMS)|A computerized method of tracking the dates and times of a pill bottle being opened.
15915449|NCT03531801|Other|Pressure algometry and mapping referred pain areas|The described procedures are tested at baseline and 24 hours after exercise-induced muscle soreness conditions.
15915450|NCT03531788|Device|Armon Ayura (Kinova)|Actively assisted mechanical arm support (electric powered to balance arm)
15915451|NCT03531788|Device|JAECO Wrex|Passive mechanical arm support (elastic bands to balance arm)
15915452|NCT03531775|Diagnostic Test|Upright MRI|Participants will be scanned using an upright MRI in sitting/standing position and supine position. They will also be scanned in supine position using a conventional MRI.
15915453|NCT03531762|Drug|Tepotinib|Participants will receive single oral dose of Tepotinib in Treatment Period A, B and C.
15915454|NCT03531762|Drug|Omeprazole|Participants will receive omeprazole alone on Day 1 to 4 and co-administration of omeprazole with Tepotinib on Day 5 in Treatment Period B and C.
15915455|NCT03531749|Dietary Supplement|HIV+ MRPJ|supplemented with (1g/d) MRPJ
15915456|NCT03531749|Dietary Supplement|HIV+ ascorbic acid|Supplemented with (1g/d) AA
15915457|NCT03531736|Drug|Antithymocyte globulin (Rabbit)|ATG (2 mg/kg/d IV on days-8 through -7)
15915458|NCT03531736|Drug|fludarabine|fludarabine (30 mg/m2/d on days -5 through -2)
15915459|NCT03531736|Radiation|total body irradiation|TBI 200 cGy (days -2 and -1) given post stem cell infusion
15915460|NCT03531736|Drug|cyclophosphamide|cyclophosphamide given post stem cell infusion (50 mg/kg on days +3 and +4)
15915461|NCT03531736|Drug|Rituxan|Rituxan (200 mg/m2) will be given to reduce the risk of EBV viremia
15915462|NCT03531736|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Allogeneic Hematopoietic Stem Cell Transplantation
15915463|NCT03531723|Other|Measuring the size of the 3rd ventricle by ultrasound|The surveillance of the clamping test is essentially clinical. No cerebral imaging is performed systematically in our service protocol.The study consisted of including ultrasound measurements during the usual weaning protocol of the service.All patients receiving a SEV withdrawal test will be included. Inclusion begins when the clinician in charge of the patient initiates the withdrawal test. The measurements will be performed blindly by a trained physician who does not participate in the patient's care. Four measurements will be made, with recording of ultrasound loops
15915464|NCT03531710|Biological|UB-311|Intramuscular injection
15915465|NCT03531710|Drug|Placebo|Intramuscular injection
15915466|NCT03531697|Drug|Generic Loteprednol Etabonate|Drug
15915467|NCT03531697|Drug|Reference Listed Drug (RLD)|Drug
15915468|NCT03531684|Dietary Supplement|MMFS-205-SR|Twice daily, oral, 500 mg tablets
15915469|NCT03531684|Dietary Supplement|Placebo|Twice daily, oral
15915470|NCT03531671|Device|Binocular-OCT|Binocular Optical Coherence Tomographer used to assess both eyes in the same session without the need for a trained assistant.
15915471|NCT03531645|Drug|Fulvestrant|"Neoadjuvant Treatment (Cycles 1-4): Fulvestrant 500 mg injection in buttocks on Days 1 and 15 of Cycle 1 and Day 1 of Cycles 2-4.
~Adjuvant Treatment (Cycles 5 and beyond): Fulvestrant 500 mg injection in buttocks on Day 1 of each cycle.
~Study cycle is 28 days."
15915472|NCT03531645|Drug|Abemaciclib|"Neoadjuvant Treatment (Cycles 1-4): Abemaciclib 150 mg by mouth On Days 1-28 of each cycle.
~Adjuvant Treatment (Cycles 5 and beyond): On Days 1-28 of each cycle, you will take Abemaciclib 150 mg by mouth on Days 1-28 of each cycle.
~Study cycle is 28 days."
15915473|NCT03531632|Biological|MGD007 + MGA012|MGD007 and MGA012 are administered by IV infusion.
15915474|NCT03531606|Drug|Mechnicov probiotics|"Using placebo comparator with experimental one, it will be compared between two group for comparison of placebo comparator with experimental one.
~The patients enrolled into expeimental group will take one pack of 'Mechnicov probiotics' twice a day for 4 weeks from 1 week before surgery.
~(1 week before surgery and 3 weeks after surgery)
~The patients in placebo and experimental group should take a part in this clinical trial under the condition of 'anterior resection of colon cancer'"
15915475|NCT03531606|Drug|Placebo|"Using placebo comparator with experimental one, it will be compared between two group for comparison of placebo comparator with experimental one.
~The patients enrolled into expeimental group will take one pack of 'Mechnicov probiotics' twice a day for 4 weeks from 1 week before surgery.
~(1 week before surgery and 3 weeks after surgery)
~The patients in placebo and experimental group should take a part in this clinical trial under the condition of 'anterior resection of colon cancer'"
15915476|NCT03531593|Diagnostic Test|Ultrasound Elastography|Ultrasound elastography is a new, noninvasive technique that can assess the stiffness of the liver by the evaluation of how sound waves propagate through the liver parenchyma.
15915477|NCT03531580|Device|Magnetic Resonance Imaging|Brain imaging using magnetic resonance imaging, using several MRI sequences: structural imaging (grey matter, using T1-imaging), cerebral perfusion using arterial spin labeling), functional and effective connectivity (using resting-state functional MRI), white matter tracts (using diffusion imaging), white matter lesions (using Fluid-attenuated inversion recovery MRI (FLAIR)) and microbleeds (using Susceptibility weighted imaging (SWI))
15915478|NCT03531567|Behavioral|Virtual Reality Mystic Isle Game|8 week virtual reality based exercise program
15915479|NCT03531567|Behavioral|Standard Home Exercise Program|8 week standard occupational therapy home exercise program
15915480|NCT03531554|Dietary Supplement|ketone ester drink|395 mg of ketone ester/kg
15915481|NCT03531554|Behavioral|exercise|35 min cycling test on an upright bicycle, followed by 10 minutes of supine cycling inside a MR scanner.
15915482|NCT03531554|Procedure|muscle biopsy|biopsy from the quadriceps muscle prior to and immediately after upright bicycling
15915483|NCT03531554|Diagnostic Test|Magnetic Resonance Imaging|1H MR images and 31P MR spectra were acquired from the upper leg prior to-, during and after exercise
15915510|NCT03531333|Procedure|ultrasound guided surgery.|during surgery, the neurosurgeon will acquire ultrasound guided images (fused with the standard neuronavigation system) to evaluate the progress of tumor resection.
15915511|NCT03531320|Drug|D07001-softgel capsules|Active Ingredient:Gemcitabine hydrochloride
15915512|NCT03531307|Other|Data correlation|Correlation between lactate levels and Ki-67 index
15915484|NCT03531541|Device|Application of TENS|The subject's skin will be cleaned with mild soap and water. Two square self-adhesive electrodes (5x5cm) will be placed 1 cm below the olecranon of the ulna and 10 cm above the radiocarpal joint of the dominant hand, maintaining the PPT measurement region between two electrodes. Two identical TENS units will be used: an active and a placebo (Neurodyn Portable TENS, IBRAMED). The active unit will be applied with the patient in a supine position at a high frequency of 100 Hz, and pulse duration of 100 µs. Strong but comfortable intensity as dictated by each subject will be applied for 20 minutes. Participants will be asked about the intensity of TENS every 5 minutes, and if the intensity has faded, the intensity will be increased again to a strong but comfortable level.
15915485|NCT03531541|Device|CJM|The examiner 3, who is responsible for cervical joint manipulation, will enter the room and stand at the head of the patient. Using the middle phalanx of the second finger of one hand, the examiner will apply pressure laterally on the joint processes of C6 and C7 vertebrae; the examiner will cradle the patient's opposite side with the other hand and then perform an ipsilateral inclination towards the C6, C7 segments, followed by a contralateral rotation to the tissue barrier to perform a high-velocity low-amplitude manipulation (thrust). If the patient does not experience joint cavitation during the maneuver, two more attempts will be made. If no sound occurs on the third attempt, the joints will be considered manipulated.
15915486|NCT03531541|Device|Placebo TENS|The application of placebo TENS will be at a frequency of 100 Hz and pulse duration of 100 µs for 30 seconds. After the initial 30 seconds, the current amplitude will gradually decrease over 15 seconds until it reaches zero value. Participants will be informed that TENS can cause a slight tingling sensation or any sensation during the procedure. They will be asked every 5 minutes if they are comfortable, without increasing intensity as in the active TENS group
15915487|NCT03531541|Device|Placebo CJM|Placebo CJM will be performed using an identical position to the active manipulation, however, for only 15 seconds, as proposed by some authors that have used placebo group in their studies. The examiner shall not exert tension in the joint capsule of the segment to ensure the placebo effect. The maneuvers will be carried out by a physiotherapist with more than 5 years of experience in manual therapy. The active or placebo manipulation will be performed on the right or left side according to randomization.
15915488|NCT03531528|Other|Diet|A 4-week protein-sparing, very low-calorie, ketogenic diet and a subsequent 6-week hypocaloric, low glycemic index, Mediterranean-like diet
15915492|NCT03531489|Device|AIR-AD|Non-significant risk medical device as decided by institutional review board
15915493|NCT03531476|Behavioral|Online Chronic Pain Management Program|With the support of a study therapist, the participant will be enrolled in a 5 week self-directed pain management program. The study therapist is a registered health professional. The program will consist of 5 weeks of mindfulness training. The mindfulness training focuses on the basics of mindfulness-based interventions including body, emotions, sensations, thoughts, compassion, pain and stress management.
15915494|NCT03531463|Procedure|Operative treatment with Reversed Total Shoulder Prosthesis|"The standardized approach is the delto-pectoral to minimize any damage of the deltoid muscle. A cemented monoblock humeral stem will be implanted. Braided polyester suture-cerclages engaging the insertion of the subscapular and infraspinatus tendons enforced by a bonegraft or a horseshoe-graft from the humeral head will be used"
15915495|NCT03531450|Behavioral|Cognitive Behavioral Therapy|Treatment sessions will use active, structured techniques to alter distorted thoughts, with a focus on acquiring and practicing cognitive and emotional modulatory skills. In particular, cognitive restructuring is used to help patients recognize the relationships between thoughts, feelings, and behaviors. Patients learn to identify, evaluate, and challenge negative thoughts. Patients will also learn behavioral strategies to decrease avoidance behavior and increase toleration of physical sensations.
15915496|NCT03531437|Drug|1.5 mg estradiol and 2.5 mg nomegestrol acetate|
15915497|NCT03531437|Drug|15 µg ethinylestradiol and 60 µg gestodene|
15915498|NCT03531424|Procedure|Angiographic guided PCI|Angiographic guided PCI is coronary revascularization based on stand-alone angiography.
15915499|NCT03531424|Procedure|Augmented-Reality CTA guided PCI|Augmented-Reality CTA guided PCI is coronary revascularization based on systematic use of CTA datasets displayed in augmented-reality glass plus coronary angiography.
15915500|NCT03531398|Other|Metabolic test meal challenge|Metabolic test meal challenge
15915501|NCT03531385|Diagnostic Test|Central sensitisation|Central Sensitization Inventory, which is a comprehensive self-report inventory to assess the overlapping symptom dimensions of central sensitisation syndrome will be used to identify participants with central sensitisation.
15915502|NCT03531385|Diagnostic Test|Neuropathic pain|Frequency of neuropatic pain will be investigated using Pain Detect Questionnaire
15915503|NCT03531385|Other|Sleep disturbance|Assessment of sleep disturbance will be assessed by Pittsburgh Sleep Quality Index
15915504|NCT03531385|Other|Quality of life|Quality of life will be assessed by the Nottingham Health Profile
15915505|NCT03531372|Device|Mipolixin®|1.55g chewable tablet 5 times a day for 2 weeks
15915506|NCT03531372|Device|Poliprotect®|1.55 g chewable tablet 5 times a day for 2 weeks
15915507|NCT03531359|Device|TIBD|Table-based Interactive Distraction using video-games will be used to prove efficacy in preventing preoperative anxiety.
15915508|NCT03531359|Drug|Midazolam|Administration of midazolam oral or rectal 30 minutes to one hour prior to transfer to the theater.
15915509|NCT03531346|Other|Daily-disposable soft contact lens|Subjects were refitted with Silicone-Hydrogel (Delefilcon A) or Hydrogel (Omafilcon A) daily-disposable soft contact lenses based on their fit, reported comfort and tear film surface quality.
15915513|NCT03531294|Drug|Aflibercept Injection|intravitreal 2mg aflibercept injection
15915514|NCT03531281|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allo-HCT
15915515|NCT03531281|Drug|Cyclophosphamide|Given IV
15915516|NCT03531281|Drug|Etoposide|Given IV
15915517|NCT03531281|Drug|Goat Milk|Given human lysozyme goat milk PO
15915518|NCT03531281|Other|Laboratory Biomarker Analysis|Correlative studies
15915519|NCT03531281|Biological|Palifermin|Given IV
15915520|NCT03531281|Drug|Sirolimus|Given PO
15915521|NCT03531281|Drug|Tacrolimus|Given IV and PO
15915522|NCT03531281|Radiation|Total-Body Irradiation|Undergo FTBI
15915523|NCT03531268|Other|PGx Testing|Pharmacogenomic (PGx) testing will be administered to all subjects. The results of PGx testing will be evaluated for clinical utility. Subjects will be evaluated based on whether PGx testing has clinical utility or has no clinical utility.
15915524|NCT03531255|Drug|Pegcetacoplan|Complement (C3) Inhibitor
15915525|NCT03531242|Biological|0.5 mL Inactivated, Dried, C-84, TSI-GSD 205, Lot 7, Run 1|"administered as dose(s) of 0.5 mL given subcutaneously in the upper outer aspect of the triceps area. Subjects who showed an initial immune response ≥ 1:20 to TC-83 and whose titer decreased over time or who rollover from a previous VEE C-84 protocol will receive a single 0.5 mL booster dose of C-84 vaccine.
~Subjects who were initial non-responders (< 1:20) to TC-83 will be given subcutaneous 0.5 mL injections on Days 0, 28-35, and 56-63"
15915526|NCT03531229|Drug|Placebo|Placebo to Lu AF76432 oral solution
15915527|NCT03531229|Drug|Lu AF76432|Lu AF76432 oral solution 2.5 mg/ml. Starting dose will be 3,5 mg, actual doses for following cohorts will be defined based on results from preceding dosing group(s).
15915528|NCT03531216|Other|Rosemary essential oil|Topically-applied oil to both dorsal and palmar aspects of the hands
15915529|NCT03531216|Other|Placebo|Topically-applied oil to both dorsal and palmar aspects of the hands
15915530|NCT03531203|Dietary Supplement|Soursop supplementation|The soursop supplementation was given to treatment group (with soursop group) 2 times a day for 100 g each for 3 months period.
15915531|NCT03531203|Other|Placebo|Control group (without soursop group) was left without treatment during study period
15915532|NCT03531190|Dietary Supplement|Nutritional supplement (Protein + MIX)|Protein supplement as needed + 750 mg vitamin C, 15 g. arginine, 35 mg. zinc and two multivitamin tablets, by mouth every day for 35 days.
15915533|NCT03531190|Dietary Supplement|Nutritional supplement (Protein)|Protein supplement as needed
15915534|NCT03531177|Behavioral|HEAL-D|HEAL-D is a 7 session programme of self-management education and behaviour change support for African and Caribbean patients with type 2 diabetes. The sessions will support participants with behaviour change to adopt evidence-based diet and physical activity targets for type 2 diabetes. The intervention has been systematically developed with defined theory and behavioural change techniques mapped to this theory.
15915535|NCT03531177|Behavioral|Control|Participants receive usual care from their healthcare team.
15915536|NCT03531164|Other|kAYAK ERGOMETER GROUP|Kayak ergometer training for 30 min 5 times a week for 6 weeks. The training includes a warming (pre charge) during 3 minutes, a training (charge) characterised by 3-5 intervals with medium to high intensity during 2-4 minutes and pauses of 1-2 minutes between active phases and 2 minutes of cooling down (post charge) to complete 30 minutes of training.
15915537|NCT03531164|Other|CONTROL GROUP|Proprioceptive neurofacilitation exercises focused in trunk control during 30 minutes 5 times a week for 6 weeks.
15915538|NCT03531138|Other|Pulmonary Rehabilitation|All patients will undergo supervised pulmonary rehabilitation program on 2 days per week for 3 months. Apart from that, they will ask to perform the home exercise program which is scheduled as 3 days per week and fill out the exercise follow-up form. Supervised exercise sessions consist of aerobic(treadmill walking, bicycle training, arm ergometer training) and strengthening training(free weights). A 6-min walk test, a 10-meter walking speed test and a 5 times sit to stand test will be performed to determine the exercise capacity of the patient. The tests will be carried out at the beginning and end of rehabilitation. At each testing session, the tests will be performed sequentially by the same physiotherapist, giving 20 minute rest periods within the same day.
15915539|NCT03531125|Procedure|Endoscopic Ultrasound|Endoscopic ultrasound for tumour biopsy collection
15915540|NCT03531125|Procedure|Pancreaticoduodenectomy|Surgery to remove pancreatic tumour
15915541|NCT03531112|Behavioral|Appetite Awareness Treatment|The goal of Appetite Awareness Treatment (AAT) is to enable participants to be able to relearn their stomach's hunger signals and begin to obey and monitor functions of satiety. AAT has been successful in helping participants diagnosed with Binge Eating Disorder (BED) and bulimia nervosa reduce binge eating, overeating, urges to eat in response to non-appetite stimuli, and prevent weight gain. The AAT intervention includes eight 60-minute group sessions. All sessions involve didactic training, review of self-monitoring of eating episodes, interactive activities, and homework assignments to enable participants to practice learned skills. Participants will be provided a workbook, which will include session content, and self-monitoring forms.
15915542|NCT03531099|Procedure|treatment with focal HIFU|HIFU treatment will be conducted with the Focal One® device. The treatment area will be defined using MRI data and 3D biopsies. A safety distance of at least 9 mm will be defined around the tumor. An intraoperative contrast echocardiographic control will be performed to evaluate the necrotic area. If necessary, additional HIFU lesions will be performed during the same session. In case of residual tumor demonstrated during control biopsies, additional treatment of this tumor with focal HIFU may be proposed.
15915543|NCT03531099|Biological|PSA dosage|PSA dosage will be regularly performed during patient follow up thanks to blood sampling.
15915544|NCT03531099|Device|MRI|MRI exam will be regularly performed during patient follow up.
15915545|NCT03531099|Other|Questionnaires|Patients will have to complete five questionnaires during their follow up : QLQ-C30 (Quality of Life questionnaire), EPIC-26 (The Expanded Prostate Cancer Index Composite), IPSS (International Prostate Score Symptom), IIEF-5 (The International Index of Erectile Function), STAI-YB (State-Trait Anxiety Inventory)
15915546|NCT03531099|Procedure|Prostatic biopsies|Prostatic biopsies will be regularly performed during patient follow up.
15915547|NCT03531086|Drug|Ioflupane I 123|Ioflupane I 123 will be administered IV push prior to SPECT imaging
15915584|NCT03530787|Other|Acetyl Zingerone Topical Cream|Topical cream with an active acetyl zingerone component.
15915548|NCT03531073|Drug|Methotrexate|This study is observational and patients will receive treatment for their psoriatic arthritis as clinically indicated. As per standard practice in this observational cohort, patients are most likely to be treated with methotrexate as the most common first line therapy in PsA. This cohort is the basis of a TWiCs (Trials Within Cohorts) study design and interventional studies will be nested within this in future. Whilst the cohort will receive treatment for their PsA as part of their routine clinical care, this treatment will be decided according to routine care and not protocolised.
15915549|NCT03531060|Drug|IRL790|IRL790 capsule 10 mg
15915550|NCT03531060|Drug|Placebo|Placebo capsule
15915551|NCT03531047|Procedure|Customised CXL|As for standard CXL, following mechanical removal of the corneal surface layer (epithelium), 0.1% riboflavin drops will be applied every 2 minutes for 10 minutes prior to ultraviolet A (UVA) irradiation - UVA power, distribution and timing as determined by analysis of Pentacam tomography scans. A bandage contact lens will be applied to encourage regrowth of the corneal surface and reduce post-operative pain.
15915552|NCT03531034|Other|Combined Exercise Training|The program consisted of 30 sessions of combined aerobic and resistance exercises training during 10 consecutive weeks. Each session lasted 45 minutes and consisted of 5 minutes warm-up, 20 minutes of resistance exercise and 20 minutes of aerobic exercise. The resistance training was performed in two sets of 15 repetitions in seven exercises of weight training (Based on 1 repetition maximum test - 1RM) for large muscle groups. The aerobic exercise was performed on a treadmill, at a speed of 5.5 km/h and intensity (imposed by treadmill inclination and heart rate) between ventilatory threshold 1 and 2 intensities. After 5 weeks of training, 1RM test was performed again to readjust the resistance load and aerobic intensity was readjusted by heart rate predicted in the incremental test.
15915553|NCT03531021|Behavioral|Heart healthy intervention|Intervention consists of educational modules, goal setting and brainstorming around strategies and barriers, and a series of heart healthy challenges such as walking a certain number of steps or eating healthy foods a certain number of times in a week.
15915554|NCT03530995|Drug|Belumosudil|Development candidate
15915555|NCT03530995|Drug|Itraconazole|Perpetrator drug
15915556|NCT03530995|Drug|Rabeprazole|Perpetrator drug
15915557|NCT03530995|Drug|Rifampicin|Perpetrator drug
15915558|NCT03530995|Drug|Omeprazole|Perpetrator drug
15915559|NCT03530982|Other|Intensive goal training|Intensive goal training : 30 hours during 2 weeks
15915560|NCT03530969|Behavioral|Self-Efficacy Assessment|"Health Care Professional's self-efficacy will be assessed by 12 ratings of self-reported confidence from (1) strongly disagree to (5) strongly agree in module-specific topics both before and after the training."
15915561|NCT03530969|Behavioral|UCLA Geriatrics Attitudes Scale|The UCLA Geriatrics Attitudes Scale is a 14-item scale developed to assess health care providers' attitudes toward older persons and caring for older patients.
15915562|NCT03530969|Behavioral|Course Evaluations|The evaluation surveys for each of the three modules will contain fifteen statements assessing post-training attitudes regarding the skills learned and application of skills in oncology clinical practice, measured on a 5-point Likert scale.
15915563|NCT03530969|Behavioral|The Consultation and Relational Empathy (CARE) questionnaire|The Consultation and Relational Empathy (CARE) questionnaire is a 10-item self-report scale that measures a patient's satisfaction with how empathic their health care providers (HCP) was within a specific consultation.
15915564|NCT03530969|Behavioral|Consumer Assessment of Health Care Providers and Systems Program (CAHPS)|"Patients perceptions of the quality of their interactions with their clinicians will be rated with 6 items from the Consumer Assessment of Health Care Providers and Systems Program (CAHPS)"
15915565|NCT03530969|Behavioral|Patient activation measure (PAM) scale|The PAM scale contains 22 items that assess patient engagement in their care process.
15915566|NCT03530956|Device|Ankle Mimicking Prosthetic Foot prototype 4+|The amputee will walk with AMPfoot 4+, a novel bionic foot, designed and built by an engineer of department MECH (VUB, B)
15915567|NCT03530943|Behavioral|Animal Assisted Activities|Students interact with canines in small group settings under the supervision of their handlers during structured and semi-structured activities designed to strengthen physiological, emotion and behavioral regulation
15915568|NCT03530943|Behavioral|Academic Stress Management tools|Evidence-based workshops focus on evidence-based content and activities designed to enhance academic stress management knowledge and skills, motivation and learning, adaptive sleep, and study and test-taking behavior through strengthening physiological, emotion and behavioral regulation
15915569|NCT03530930|Drug|Comarum Palustre|Comarum Palustre tablets 500 mg BID, 1 month
15915570|NCT03530917|Drug|RO7020531|4 SAD Cohorts with individual dosages of 40, 100, 140 and 170 mg hard capsules and 3 MAD Cohorts with dosages of 100 and 150mg hard capsules, will be administered orally as per the dosing schedules described above.
15915571|NCT03530917|Drug|Placebo|Placebo hard capsules will be administered orally as per the dosing schedules described above.
15915572|NCT03530904|Other|mobilization|Early mobilization after CIED implantation
15915573|NCT03530891|Procedure|Computer guided lag screw fixation|Under general anaesthesia: Patient specific pre operative prefabricated surgical guide will be used intra operative for open reduction and internal fixation for anterior mandibular fracture using lag screws.
15915574|NCT03530891|Procedure|Conventional lag screw fixation|Under general anaesthesia: Open reduction and internal fixation for anterior mandibular fracture utilising lag screws.
15915575|NCT03530878|Procedure|Hip Arthroscopy|Intraarticular pathology in the form of labral tears and cartilage that are often concomitant with DDH
15915576|NCT03530852|Device|Relizorb|Tube feeds run across device to digest fats.
15915577|NCT03530839|Procedure|Arthrodesis|see study group description
15915578|NCT03530839|Procedure|Resection arthroplasty|see study group description
15915579|NCT03530826|Other|No intervention|No Intervention
15915580|NCT03530813|Other|Ebook Asthma First Aid in School Training|Technology assisted, self-directed learning eBook resource
15915581|NCT03530813|Other|Face-To-Face Asthma First Aid in Schools Training|School Asthma First Aid Management Program 3 Hour Face to Face Training
15915582|NCT03530800|Drug|Dronabinol|Dronabinol for 10 weeks (5mg per day first 2 weeks, 10mg per day second two weeks, 15mg per day last six weeks)
15915583|NCT03530800|Drug|Placebo|Placebo for 10 weeks
15947305|NCT03284957|Drug|Abemaciclib|Pharmaceutical form: tablet
15915585|NCT03530787|Other|Topical cream|Topical cream without an active acetyl zingerone component and just the carrier cream.
15915586|NCT03530774|Dietary Supplement|powdered egg white protein supplement|consumption of egg white protein supplement daily for 6 months
15915587|NCT03530774|Dietary Supplement|maltodextrin supplement|consumption of maltodextrin supplement daily for 6 months
15915588|NCT03530748|Procedure|Endovascular therapy and Imaging Acquisition|"Endovascular repair for renal artery stenosis;
~Parenchymal Blood Volume(PBV) acquisition and analysis for target kidney"
15915589|NCT03530735|Other|Finger-prick Autologous Blood (FAB)|"Patients will be instructed to use FAB therapy by:
~Hand hygiene with soap and water. Dry, then wipe their fingertip with an alcohol street before leaving to air dry.
~Use a diabetic lancet to prick their cleaned fingertip.
~Squeeze 5 drops of blood form their finger into 10ml of saline.
~Gargle the blood-saline mixture for 5 minutes.
~Swallow the blood-saline mixture.
~Repeat this 4 times per day."
15915590|NCT03530709|Other|videoconferencing|Parents/caregivers will use smartphones to videoconference in their SCC provider during PCP visits
15915591|NCT03530696|Drug|Palbociclib|Compare progression free survival of the combination arm (T-DM1 with palbociclib) to single agent T-DM1
15915592|NCT03530696|Drug|T-DM1|Compare progression free survival of the combination arm (T-DM1 with palbociclib) to single agent T-DM1
15915593|NCT03530683|Drug|TTI-622|TTI-622 will be administered by intravenous infusion.
15915594|NCT03530683|Drug|Azacitidine|75 mg/m^2 intravenous (IV) or subcutaneous (SC) daily for 7 days, repeated every 4 weeks
15915595|NCT03530683|Drug|Venetoclax|400 mg orally daily for each day of each cycle (except for Cycle 1, where Day 1=100 mg and Day 2=200 mg; first 7 doses taken in clinic). The ramp-up and target dose of venetoclax will be adjusted per the package insert in subjects who are taking concomitant moderate or strong CYP3A4 inhibitors or posaconazole
15915596|NCT03530683|Drug|Carfilzomib|Days 1, 8, and 15 of 28-day cycles; 20 mg/m^2 IV given on Cycle (C) 1 Day (D) 1, and if tolerated, then 70 mg/m^2 IV given starting on C1D8 and subsequent doses thereafter
15915597|NCT03530683|Drug|Dexamethasone|40 mg orally or IV on Days 1, 8, 15, and 22 of 28-day cycles
15915598|NCT03530670|Other|oral midazolam|0.5 mg/kg oral midazolam administered 20 minutes before anesthesia induction
15915599|NCT03530670|Other|Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.|"Patients will be watched a short movie (at URL:
~http://www.animaturk.com/animasyon/suko-ameliyat-oluyor.html#.Wd-YhFu0PIU) 20 minutes before induction."
15915600|NCT03530670|Other|Playing smartphone game|Patients will be played with smartphone (angry birds, subway surfers or snail Bob) 20 minutes before induction
15915601|NCT03530644|Device|WM3.4NR|The investigational medical device will collect spectral Raman data from tissue.
15915602|NCT03530644|Device|P0.1|The investigational medical device will collect spectral Raman data from tissue.
15915603|NCT03530631|Drug|Adderall|Participants will be administered Adderall
15915604|NCT03530631|Drug|Placebo|Participants will be administered placebo
15915605|NCT03530618|Device|Flexible tip straight guidewire|Use a flexible tip straight guidewire for ultrasound-guided central venous catheterization
15915606|NCT03530618|Device|J-tip|Use a J tip straight guidewire for ultrasound-guided central venous catheterization
15915607|NCT03530605|Device|Optune TTF device|portable device which produces electrical fields
15915608|NCT03530592|Device|Seated Ankle Robot Training|This intervention employs the use of an adaptive ankle robot control system over a 6-week intervention period.
15915609|NCT03530579|Behavioral|Educational group trainings|"Participants will receive 6 two and a half hour educational group training's over the course of 6 months. These sessions will be led by a trained CHW in your language and will be held on a monthly basis in a community based location.
~Session 1: What is Diabetes
~Why is Prevention Important
~Session 2: Nutrition Session 3: Physical Activity Session 4: Cardiovascular Disease & Diabetes Complication Session 5: Stress Management Session 6: Access to Service"
15915610|NCT03530579|Behavioral|Community Health Care Worker|A community health care worker answer your questions about diabetes and refer participant to a physician. Survey will be completed at the start of the study and during the 3rd, 6th and 12th months
15915611|NCT03530566|Other|PnK® Method|A multidisciplinary program of weight loss based on diet (initially very low ketogenic diet), physical activity and emotional support
15915612|NCT03530566|Other|standard diet|standard low calorie diet for weight loss
15915613|NCT03530553|Other|Hunt Motivational Scale|The Hunt Motivational Scale is a tool to help facilitate weight loss and motivate patients to track, plan, and practice healthy weight loss and weight maintenance practices.
15915614|NCT03530540|Device|low-intensity extracorporeal shockwave therapy|Active shockwaves
15915615|NCT03530540|Device|Placebo LI-ESWT|Placebo shockwaves
15915616|NCT03530540|Device|Penile pump|both groups will be treated with a penile pump
15915617|NCT03530527|Procedure|ERCP with biliary stenting|ERCP with biliary stent is performed using a side view duodenoscope of Olympus (TJF-160). Biliary cannulation is performed using a sphincterotome and 0.035 inch jag wire, and cholangiogarm is done to assess common bile duct diameter, and length of biliary stricture. Biliary sphincterotomy is then performed. A straight biliary stent is placed across stricture bile duct.
15915618|NCT03530527|Procedure|EUS guided biliary drainage|EUS guided biliary drainage is performed using a linear echoendoscope of Olympus (GFUCT240). Extrahepatic bile duct was identified from duodenal bulb, then 19 G needle is inserted into bile duct with confirmed with cholangiogram. The fistula tract is dilated using a 6 Fr cystotome (Wilson Cook Medical). A double pigtail stent is placed across biliary-enteric fistula.
15915619|NCT03530514|Drug|REGN4461|REGN4461
15915620|NCT03530514|Drug|Placebo|Placebo-matching REGN4461
15915621|NCT03530501|Other|Diet|Very low calorie ketogenic diet followed by low calorie diet
15915622|NCT03530501|Dietary Supplement|Synbiotic1|B. lactis, Lactobacillus rhamnosus, B. longum ES1 and prebiotics fiber
15915623|NCT03530501|Dietary Supplement|Synbiotic2|B. animalis subsp. lactis and prebiotics fiber
15915624|NCT03530488|Drug|Lidocaine|intrauterine and intracervical instillation of 4 ml of lidocaine 2% diluted in 15 ml normal saline
15915625|NCT03530488|Procedure|Office hystroscopy|A rigid 3.5 mm hystroscope with an optic of 30 degrees was used. Normal saline solution was used as distension media, with 120 mmHg intrauterine pressure, Vaginoscopic approach, nocervical tenaculum or dilators used.
15915626|NCT03530475|Diagnostic Test|ultrasound and doppler|"• Ultrasound examination (2D gray scale and color doppler )
~1. Confirming the presence of placenta previa 2,To assess the possibility of concomitant placenta accreta (Sonographic findings that have been associated with placenta accreta (1) Loss of normal hypoechoic retroplacental zone (2) Multiple vascular lacunae (irregular vascular spaces) within placenta, (3) Blood vessels or placental tissue bridging uterine-placental margin, myometrial-bladder interface, or crossing uterine serosa1 (4) Retroplacental myometrial thickness of 1 mm (5) Bladder wall interruption (6) Presence of placental bulge (7) Utero-vesical hypervascularity (8) presence of lacunae feeder vessels.
~3. Assessment of uterine artery Doppler in different cases of placenta previa.
~. Documentation of the operative findings during cesarean section and/or cesarean hysterectomy procedures.
~Histopathological examination of the hysterectomy specimens to assess the degree of myometrial invasion."
15915627|NCT03530462|Drug|rituximab|375 mg/m2 weekly for 4 weeks
15915628|NCT03530462|Drug|cyclophosphamide|750 mg/m2 monthly for 4-6 cycles depending on the response
15915629|NCT03530462|Drug|Steroids|500-1000 mg of methylprednisolone daily for 3 days, then tapered doses
15915630|NCT03530462|Drug|Intravenous immunoglobulin|intravenous immunoglobulin (IVIG) with or without plasmapheresis
15915631|NCT03530449|Device|OCT Angiography|OCT Angiography offers clinicians a non-invasive three-dimensional visualization of vasculature in the retina and choroid. The visualization of perfused vasculature in a three-dimensional layout, offers clinicians an aid in the identification of retinal and choroidal pathologies such as retinal ischemia, microaneurysms, retinal neovascularization and choroidal neovascular membranes.
15915632|NCT03530449|Device|Color Fundus Photography|Non-contact white light photography
15915633|NCT03530449|Device|Optical Coherence Tomography|Two and Three dimensional cross sectional imaging of the back of the eye to look at vascular structures and is an aid in the detection and management of various ocular diseases.
15915634|NCT03530436|Dietary Supplement|Native turmeric extract|207 mg curcumin
15915635|NCT03530436|Dietary Supplement|Native turmeric extract with 7-9% volatile turmeric oils|207 mg curcumin
15915636|NCT03530436|Dietary Supplement|Turmeric extract plus mixture of phytochemicals|207 mg curcumin
15915637|NCT03530436|Dietary Supplement|Cyclodextrin complex of curcuminoids|207 mg curcumin
15915638|NCT03530436|Dietary Supplement|Turmeric oleoresin|207 mg curcumin
15915639|NCT03530436|Dietary Supplement|Liposomal curcumin|207 mg curcumin
15915640|NCT03530436|Dietary Supplement|Phytosomal curcumin|207 mg curcumin
15915641|NCT03530436|Dietary Supplement|Micellar turmeric extract|207 mg curcumin
15915642|NCT03530410|Device|Intragastric balloon placement|Patients will have endoscopic placement of intragastric balloon that will be removed endoscopically after 6 months
15915643|NCT03530397|Biological|MEDI5752|Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation.
15915644|NCT03530397|Drug|Pemetrexed|Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation
15915645|NCT03530397|Drug|Carboplatin|Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation
15915646|NCT03530397|Biological|Pembrolizumab|Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation
15915647|NCT03530384|Other|Cognitive training|Computerized cognitive training targeting inhibitory control of motor response used during 45 minutes sessions twice a week for 6 weeks
15915648|NCT03530384|Other|Control training|Fictitious computerized training used during 45 minutes sessions twice a week for 6 weeks
15915649|NCT03530371|Drug|Dexmedetomidine Hydrochloride|intranasal administration of 2.5µg/kg of dexmedetomidine to fall asleep the patients
15915650|NCT03530358|Device|Technology-aided rehabilitation|"VRRS involves performing different kinds of motor tasks with the patient holding a real manipulable object in their hands while interacting with a virtual scenario.
~Braccio di Ferro task consists in center-out reaching movements and return. The subject is required to start from a central target, reach one of five peripheral targets arranged on a semi-circle with a 20 cm radius and then return to the central target."
15915651|NCT03530358|Behavioral|Conventional rehabilitation|The patients will be asked to perform a wide range of exercises, including: shoulder flexion-extension, abduction-adduction, internal-external rotation, circumduction, elbow flexion-extension, forearm pronation-supination, hand-digit motion. Standardized instructions and modalities will be followed when providing exercises to the patients in order to control for any variability in leading the therapy session due to the therapist.
15915652|NCT03530345|Drug|Neridronic acid 100 mg|100 mg neridronic acid supplied in glass vials in 8 mL of excipients.
15915653|NCT03530345|Drug|Placebo|Glass vials with matching placebo.
15915654|NCT03530332|Diagnostic Test|PreTRM test|Blood test to determine risk of preterm birth
15915655|NCT03530319|Drug|Doxycycline|Oral doxycycline is given with a dosage of 2-4 mg/kg/day divided into twice a day for 5-10 days.
15915656|NCT03530319|Drug|Azithromycin|Azithromycin is given with a dosage of 10 mg/kg/day once a day for 3 days.
15915657|NCT03530306|Device|PS1-PS4|Participants in this arm shall be given PS1 during the first half of treatment and PS4 during the second half of treatment. During the expected 12-week treatment period, the participants will be presented with audio stimuli and electrical pulses for somatosensory stimulation.
15915658|NCT03530306|Device|PS6-PS10|Participants in this arm shall be given PS6 during the first half of treatment and PS10 during the second half of treatment. During the expected 12-week treatment period, the participants will be presented with audio stimuli and electrical pulses for somatosensory stimulation.
15915659|NCT03530306|Device|PS7-PS4|Participants in this arm shall be given PS7 during the first half of treatment and PS4 during the second half of treatment. During the expected 12-week treatment period, the participants will be presented with audio stimuli and electrical pulses for somatosensory stimulation.
15915660|NCT03530306|Device|PS9-PS6|Participants in this arm shall be given PS9 during the first half of treatment and PS6 during the second half of treatment. During the expected 12-week treatment period, the participants will be presented with audio stimuli and electrical pulses for somatosensory stimulation.
15915661|NCT03530293|Drug|Valbenazine|vesicular monoamine transporter 2 (VMAT2) inhibitor
15915662|NCT03530293|Drug|Placebo oral capsule|non-active dosage form
15915663|NCT03530280|Drug|pregabalin (lyrica)|preoperative pregabalin and the postoperative sham block will perform.
15915664|NCT03530280|Drug|Placebo oral tablet|The preoperative placebo oral tablet and the postoperative sham block will perform.
15915665|NCT03530280|Drug|adductor canal block including bupivacaine|The preoperative placebo oral tablet and adductor channel block including 10 mL of 0.25% bupivacaine with 5 μg/mL epinephrine
15915666|NCT03530267|Drug|Aflibercept + mLV5FU2|Patients receive aflibercept 4mg/kg as 1-h infusion followed by folinic acid 350 mg/m² by 2-h intravenous infusion, 5-fluorouracil 1920 mg/m² 46-h intravenous infusion (mLV5FU2) every 2 weeks (qd15).
15915667|NCT03530267|Drug|mFOLFOX7|Patients in this arm receive modified (m) FOLFOX 7: Folinic acid 350 mg/m² and oxaliplatin 68 mg/m² by concurrent 2-h intravenous infusion, 5-FU 1920 mg/m² 46-h intravenous infusion every 2 weeks (qd15).
15915668|NCT03530254|Diagnostic Test|PGT-A|PGT-A will be carried out following the usual clinical practice. Trophectoderm biopsy samples from blastocysts are analyzed by NGS to screen for numerical chromosomal abnormalities.
15915669|NCT03530254|Diagnostic Test|ERA Test|The ERA test requires an endometrial biopsy and will determine if the endometrium is receptive or not by analysing the expression levels of 236 genes involved in endometrial receptivity, to assess the optimal time to place an embryo into the uterus and promote a successful implantation and pregnancy.
15915670|NCT03530241|Diagnostic Test|Presence of bile duct stones|MRCP verified gall stones in the bile ducts
15915671|NCT03530241|Diagnostic Test|Non-presence of bile duct stones|MRCP without bile duct stones
15915672|NCT03530228|Drug|Tegoprazan (C1)|Tegoprazan QD, oral administration. Treatment A
15915673|NCT03530228|Drug|Tegoprazan (C1)|Tegoprazan QD, oral administration. Treatment B
15915674|NCT03530228|Drug|Treatment C: Tegoprazan (C1)|Tegoprazan BID, oral administration
15915675|NCT03530228|Drug|Tegoprazan (C2)|Tegoprazan QD, oral administration, for 7 days. Group 1
15915676|NCT03530228|Drug|Tegoprazan (C2)|Tegoprazan QD, oral administration, for 7 days. Group 2
15915677|NCT03530228|Drug|Esomeprazole (C2)|Esomeprazole QD, oral administration, for 7 days. Group 3
15915678|NCT03530228|Drug|Tegoprazan (C3)|Tegoprazan QD, oral administration
15915679|NCT03530215|Drug|Antineoplastic and Immunomodulating Agents|Antineoplastic agents, endocrine therapy, immunostimulants and immunosuppressants drugs included in the ATC classification L
15915680|NCT03530202|Drug|Creatine monohydrate|Participants will consume creatine monohydrate powder (Creapure, AlzChem AG, Trostberg, Germany) every day for 8 weeks. On training days participants will consume supplement immediately after each training session (~ 5 minutes) mixed in water as post-exercise creatine ingestion enhances its uptake into muscle and promotes increased muscle mass. On non-training days, supplements will be consumed at the participant's leisure.
15915681|NCT03530202|Drug|Maltodextrin Powder|Participants will consume Maltodextrin Powder (Globe Plus 10 DE Maltodextrin Powder, Univar Canada) every day for 8 weeks. On training days participants will consume supplement immediately after each training session (~ 5 minutes) mixed in water. On non-training days, supplements will be consumed at the participant's leisure.
15915682|NCT03530189|Drug|10% dextrose|After birth the intravenous 10% dextrose at 60-90 ml/kg/day will be started as soon as possible
15915683|NCT03530189|Drug|bolus of dextrose, reducing the glucose infusion, insulin|"Hypoglycemia will be treated with 2 mL/kg to 3 mL/kg (200-300 mg/kg) intravenous bolus of 10% dextrose.
~Hyperglycemia will be managed by reducing the glucose infusion rate or initiation of an insulin infusion."
15915684|NCT03530176|Radiation|18Fluoride-Sodium Fluoride radio-isotope|The investigators will be using 18F-NaF to image premature atherosclerosis in the coronary arteries of diabetic patients.
15915685|NCT03530163|Device|Respiratory Muscle Training|Subjects will breathe through a custom isocapnic Respiratory Muscle Training method developed in-house. The initial breathing frequency will be 30 breaths per minute. Subsequent sessions will begin with 20 minutes of breathing at the highest rate attained on the previous training day. During the last 10 minutes of each session, breathing rate will increase by 1-2 breaths/min.
15915686|NCT03530163|Device|Sham Breathing Training|Each subject in the sham group will be prompted to hold his breath for 10 seconds every 30 seconds (two times each minute) while breathing on a circuit visibly identical to that used in Respiratory Muscle Training. The subject will breathe ambient air normally after each breath hold. Each sham session will last 30 minutes total.
15915687|NCT03530150|Drug|Pirfenidone Oral Product|A pill containing 600 mg of pirfenidone
15915688|NCT03530137|Behavioral|Healthy Home|An evidence-based health literacy curriculum will be developed and implemented based on competencies of understanding and applying health information. The
15915689|NCT03530137|Behavioral|Attachment and Biobehavioral Catch-up Infant (6-24 months) and Toddler (24-48 months).|ABC includes 10 in-home, manualized sessions with parents and infants, targeting: 1) increasing parents' nurturing when children are distressed, 2) helping parents follow children's lead, 3) decreasing frightening parent behaviors, and (for ABC-Toddler) managing dysregulation.
15915690|NCT03530137|Behavioral|HealthySteps|Healthy Steps helps families identify, understand and manage parenting challenges like feeding, behavior, sleep, development and adjusting to life with a young child
15915691|NCT03530124|Biological|PCV13|ACIP Recommended vaccine
15915692|NCT03530124|Biological|DTaP|ACIP Recommended vaccine
15915693|NCT03530124|Biological|HBV|ACIP Recommended vaccine
15915694|NCT03530124|Biological|IPV|ACIP Recommended vaccine
15915695|NCT03530124|Biological|Hib|ACIP Recommended vaccine
15915696|NCT03530098|Device|BoneAgeModel|BoneAgeModel is an Artificial Intelligence tool that takes in a hand radiograph and gender, and outputs the skeletal (bone) age. The intervention involves using this tool as a factor in the clinical decision making process of the participating radiologists. The radiologist's decision will be considered final.
15915697|NCT03530085|Drug|Decitabine|Decitabine was administered at 20mg/m2/day on days -9 to -7.
15915698|NCT03530085|Drug|Busulfan (BU)|Busulfan was administered at 3.2 mg/kg/day on days -5 to -4.
15915699|NCT03530085|Drug|Fludarabine(Flu)|Fludarabine(Flu) was administered at 30mg/m2/day on days -6 to -3.
15915700|NCT03530072|Diagnostic Test|Karius Test|Next Generation Sequencing
15915701|NCT03530059|Other|Home-based rehabilitation|Observational study
15915702|NCT03530046|Combination Product|High SID fluid|The fluid will be given to the patient at a rate prescribed by the treating physician according to clinical response for a period of 2 hours or up to maximum 30ml/kg fluid is given, whichever is earlier.
15915703|NCT03530046|Combination Product|Hartmann's solution|The fluid will be given to the patient at a rate prescribed by the treating physician according to clinical response for a period of 2 hours or up to maximum 30ml/kg fluid is given, whichever is earlier.
15915704|NCT03530033|Drug|Lidocaine|Local injection of lidocaine reduces muscle tremor
15915705|NCT03530020|Other|monolithic zirconia crowns|full anatomical monolithic crowns
15915706|NCT03530020|Other|lithium silicate crowns|lithium silicate glass ceramics are highly resistance to chipping
15915707|NCT03530007|Drug|Normal saline|normal saline used for prevention of spinal shivering
15915708|NCT03530007|Drug|Ondansetron 4 MG|ondansetron 4 MG used for prevention of spinal shivering
15915709|NCT03530007|Drug|Ondansetron 8mg|ondansetron 8 MG used for prevention of spinal shivering
15915710|NCT03529994|Other|Enrollment|All infants enrolled will have work of breathing assessed.
15915711|NCT03529981|Other|Tuned Vibroacoustic Stimulation (TVS)|TVS is an exteroceptive cue that may reduce subjective and physiological indicators of stress and increase behavioral performance
15915712|NCT03529981|Other|no active intervention|No intervention will be administered
15915713|NCT03529968|Procedure|esophagectomy|Subtotal esophagectomy and proximal gastrectomy with intrathoracic esophagogastric anastomosis. Total gastrectomy and esophageal resection at the level of the azygos vein and Roux-en-Y esophagojejunostomy
15915714|NCT03529955|Drug|Apremilast 30mg|Patients with refractory cutaneous dermatomyositis will be started on apremilast 30 mg twice a day in addition to a stable dose of their treatment regimen (including steroids and steroid sparing agents).
15915715|NCT03529942|Drug|FX006 32 mg|Extended-release 32 mg FX006 IA injection
15915716|NCT03529929|Drug|Methylprednisolone|6 day dosing as dictated by Medrol 6 Day Dose Pack
15915717|NCT03529916|Other|isolation of endothelial cells precursors in blood|Circulating endothelial precursor cells will be isolated and then cultured in vitro. RNA will be then isolated.
15915718|NCT03529903|Behavioral|Health Coaching|Our trained health coaches will use the Way To Health platform to track patient health behaviors, and will communicate with patients via both SMS text messaging (up to four messages per week) and biweekly phone calls (up to one hour). During these interactions, health coaches will connect the patient to helpful resources and to help them reflect on previous goals and to set realistic, achievable goals for the upcoming weeks.
15915722|NCT03529877|Biological|allo-APZ2-EB|intravenous infusion of allo-APZ2-EB
15915723|NCT03529864|Other|Exercise Therapy|
15915724|NCT03529851|Other|Weekly questionnaires|In case of alarming symptoms reported in the questionnaire, an alert is automatically sent to the hospital. The clinicians will contact the patient, confirm the symptoms and intervene according to standard practice.
15915725|NCT03529838|Other|Combined exercise|The program consisted of 36 sessions of combined aerobic and resistance exercises training during 12 consecutive weeks. Each session lasted 60 minutes and consisted of 30 minutes of resistance exercise and 30 minutes of aerobic exercise. The resistance training was performed in two sets of 8 to 12 repetitions in five exercises of weight training (Based on 1 repetition maximum test - 1RM). The aerobic exercise was performed on a treadmill, at a speed of 5.5 km/h and intensity (imposed by treadmill inclination and heart rate) between 65 and 75% of maximun heart rate measured in maximum incremental test. Every week the resistance load and aerobic intensity was readjusted by determined training zone (8 to 12 maximum repetitions) and heart rate predicted in the incremental respectively.
15915726|NCT03529825|Drug|Rifaximin|Rifaximin will be administered twice a day orally or by nasogastric tube, at a dose of 15 mg/kg divided BID with a maximum dose of 1,650 mg, day -7 to day +28 or discharge (maximum duration 36 days).
15915727|NCT03529812|Behavioral|CBCT-informed training|Cognitively-Based Compassion Training (CBCT) is a secularized compassion meditation program adapted from the Tibetan Buddhist mind training (lojong) tradition. Lojong practices utilize a cognitive, analytic approach to challenge one's unexamined thoughts and emotions toward other people, with the long-term goal of developing altruistic emotions and behavior towards all people.
15915728|NCT03529799|Device|I-PAS Goggles|Portable, head-mounted display goggle system with integrated eye capture technology
15915729|NCT03529773|Biological|Formulation A|RSV vaccine
15915730|NCT03529773|Biological|Formulation B|RSV vaccine
15915731|NCT03529773|Biological|Placebo|Placebo
15915732|NCT03529747|Other|Online self-help|As detailed in experimental arm description.
15915733|NCT03529734|Other|12 min running|This was already explained in the description of arm
15915734|NCT03529734|Other|Local strengthening exercises|This was already explained in the description of arm
15915735|NCT03529721|Other|zumba dance fitness|females in this group will be instructed to engage into12 classes of 60-minute Zumba® fitness over an 8-week period of continuous dance movements to Latin music with varying intensity level throughout the sessions. Each session will be initiated with low-intensity movements for the ﬁrst 5 min, followed by an increasing intensity throughout the workout. At the end of the training session, the intensity will be gradually reduced.
15915736|NCT03529721|Other|non zumba dance|participants in this group will be doing their normal daily activities throughout the 8-week period.
15915737|NCT03529708|Radiation|3D CRT plus SBRT boost|Patients will receive urgent standard 3D conformal radiotherapy (3D CRT) of plus stereotactic boost to tumor causing spinal cord compression (SCC). Initial dose for 3D CRT will be either 8Gy in 1 fraction or 20Gy in 5 fractions, with SBRT boost dose15Gy in 2 fractions of 12Gy in 2 fractions (depending on 8Gy/1 or 20Gy/5 initial RT dose respectively), delivered within three weeks of first treatment.
15915738|NCT03529695|Behavioral|Standard HVP Curriculum|Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on strengthening children's cognitive skills, early literacy skills, social/emotional and physical development.
15915739|NCT03529695|Behavioral|Obesity Prevention|Obesity prevention curriculum program targets 4 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, and decreasing fried foods) aimed at reducing obesity risk in mothers and children. The module will also include weekly activity opportunities to develop social networks that foster healthy eating and physical activity.
15915740|NCT03529682|Other|exercise|10 minutes warm-up exercises and stretching exercises, 40 mınutes consecutive exercises (strengthening exercises for trunk and lower extremities) and 10 mınutes cooling down exercises and stretching exercises will be applied.
15915741|NCT03529682|Other|control group|60 mınutes in a day and 3 times in a week traditional physiotherapy program will be applied
15915742|NCT03529669|Device|Cytosponge™|Cytosponge™ is a capsule-sized device which contains an expandable, spherical mesh which is attached to a string. The capsule dissolves in the stomach after swallowing, releasing the sponge which is then retrieved by gently pulling the string after five minutes. As the sponge is pulled out it collects the cells from the lining of the gullet.
15915743|NCT03529656|Behavioral|Early rehabilitation program for liver transplantation|Deliver the one of 5-step early rehabilitation program for immediate liver transplant pts on weekday
15915744|NCT03529643|Drug|Dexmedetomidine|Anesthesia with sevoflurane-remifentanil-dexmedetomidine
15915745|NCT03529643|Other|Without dexmedetomidine|Anesthesia with sevoflurane-remifentanil
15915746|NCT03529630|Other|Inverted syringe|Application of mild suction over the mother's inverted nipple using an inverted syringe before each breastfeeding.
15915747|NCT03529617|Other|Sample collection|Plasma, urine, BAL and ascitic fluid sample collection.
15915748|NCT03529604|Other|Saliva sampling|Saliva was collected from the mouth floor using a specially designed saliva collecting apparatus.
15915749|NCT03529604|Diagnostic Test|ELISA|Saliva samples will be analyzed using enzyme-linked immunosorbent assay (ELISA) for the detection of SCCA1, SCCA2 and TROP2.
15915750|NCT03529604|Diagnostic Test|HPLC|High-performance liquid chromatography (HPLC) will be used to measure Ap4A concentrations in saliva.
15915751|NCT03529591|Device|Selective laser trabeculoplasty (SLT)|In this study, treatment naive patients with bilateral ocular hypertension or primary open angle glaucoma are treated with 180 degrees SLT in one eye and 360 degrees SLT in the contralateral eye. The primary outcome measure is assessing the response to SLT in both eyes and comparing the intraocular pressure outcomes between the two eyes of each patient.
15915752|NCT03529591|Procedure|Selective laser trabeculoplasty|In this study, treatment naive patients with bilateral ocular hypertension or primary open angle glaucoma are treated with 180 degrees SLT in one eye and 360 degrees SLT in the contralateral eye. The primary outcome measure is assessing the response to SLT in both eyes and comparing the intraocular pressure outcomes between the two eyes of each patient.
15915753|NCT03529578|Procedure|dHACM|Dehydrated human amnion/chorion membrane (dHACM) product and is regulated as a Human Cells, Tissues and Cellular and Tissue Based Product (HCT/P) under Section 361 of the Public Health Service Act by the Food and Drug Administration (FDA)
15915754|NCT03529565|Procedure|Biospecimen Collection|Undergo collection of blood
15915755|NCT03529565|Other|Laboratory Biomarker Analysis|Correlative studies
15915756|NCT03529565|Other|Quality-of-Life Assessment|Ancillary studies
15915757|NCT03529565|Other|Questionnaire Administration|Ancillary studies
15915758|NCT03529552|Procedure|Anterior Cruciate Ligament Reconstruction|Placement of an SMS bioresorbable interference screw (DEDIENNE Santé)
15915759|NCT03529539|Drug|PSV|
15915760|NCT03529526|Drug|KN046|"The modified phase I 3 + 3 study design was used in dose escalation from low dose to high dose to determine the MTD.Sequential assignment of Patient cohorts to one of five dose levels of KN046: 0.3 mg/kg,1 mg/kg,3 mg/kg,5 mg/kg,10 mg/kg."
15915761|NCT03529513|Diagnostic Test|Medibio Depression Diagnostic Aid|The Medibio DDA processes the heart rate and actigraphy data from the third-party devices, characterizes these data in comparison to the benchmark patterns of persons currently experiencing a depressive episode.
15915762|NCT03529513|Diagnostic Test|Mini International Neuropsychiatric Interview|The Mini International Neuropsychiatric Interview (M.I.N.I.) is a structured diagnostic interview that was developed as a simple tool to assist clinicians to conduct psychiatric diagnoses according to the DSM-IV and International Statistical Classification of Diseases and Related Health Problems tenth revision (ICD-10) criteria.
15915763|NCT03529513|Diagnostic Test|Hamilton Rating Scale for Depression - 17 Item|The clinician-administered Hamilton Depression Rating Scale (also known as the HAM-D) is the most widely used depression assessment scale . The original version contains 17 items (HDRS17) pertaining to symptoms of depression experienced over the past week. There are numerous versions with varying lengths that include the HDRS21, HDRS24, and HDRS29. This study will utilize the HDRS17 (HAMD-17) version.
15915764|NCT03529500|Diagnostic Test|Caries detection - dmtf index|"Dental caries experience was recorded using the dmft index, which was employed following the recommendations of the WHO to establish the prevalence and severity of caries. Active visible white spots were also recorded. The examinations were performed in duplicate for each child with the aim of establishing inter-examiner agreement using the Kappa statistic which demonstrated good agreement (K = 0.81).
~The criteria adopted for the determination of prevalence followed by guidelines of the Oral Health Surveys - Basic Methods, 4th edition (WHO, 1997) described in the examiner's manual and annotator's manual produced by the coordination team of the Brazil Oral Health Project. The severity and prevalence of dental caries were determined based on the dmft index."
15915785|NCT03529396|Drug|Primaquine|Standard primaquine (0.5mg of base/kg/day for seven days) concomitant with chloroquine.
15915806|NCT03529240|Device|Kinesiology Taping|Kinesiology taping (KT) which was developed by Dr. Kenzo Kase, is a new application of elastic and adhesive taping. KT is applied by specialized physiotherapists and physicians. This type of taping is a very frequently used technique to accelerate recovery after musculoskeletal injuries. Also, this technique is usually used as an alternative to athletic taping to support fascias, muscles, and joints for many purpose such as positioning, inhibition, and fascilitation
15915853|NCT03528863|Behavioral|Online Mindfulness Meditation|Receive web-based mindfulness meditation
15915765|NCT03529500|Diagnostic Test|Saliva flow rate|Samples of non-stimulated saliva were collected from the participants for five minutes using two aspirator tubes connected to a 15-ml Falcon tube. One aspirator tube was positioned under the child's tongue and the other was attached to the aspirator device. After five minutes, the amount of saliva was measured for the determination of salivary flow. Collections were performed between 9 and 11 am and the time of the last meal was recorded. At least a one-hour interval was required between the last meal and the collection of the saliva sample. The volume of saliva was measured. The salivary flow volume was calculated and expressed as ml/min. The following categories were considered in the analysis of salivary flow: < 0.1 ml/min = xerostomia; 0.1 to 0.6 ml/min = very low flow; 0.7 to 0.9 mL/min low flow; 1.0 to 2.0 ml/min = normal flow; and > 2.0 ml/min = high flow.
15915766|NCT03529500|Diagnostic Test|Saliva Buffering Capacity|an aliquot of 1 ml was transferred to a test tube with 3 ml of hydrochloric acid (HCl 5 mM) for titration and the determination of salivary buffering capacity (SBC). The saliva/acid solution was shaken in a q 220 vortex tube agitator (Quimis, Diadema, SP, Brazil) for 15 seconds. Next, pH was determined in a portable pH meter (KASVI K39-0014P, Curitiba, PR, Brazil) for the determination of the SBC. The following categories were considered: ≥ 5.5 = very good buffering capacity; 5.4 to 5.0 = good buffering capacity; 4.9 to 4.5 = medium good buffering capacity; 4.4 to 4.0 = low buffering capacity; and ≤ 3.9 very low buffering capacity.
15915767|NCT03529487|Drug|Oxymetazoline|Oxymetazoline gel applied intra-analy
15915768|NCT03529474|Other|Psychology and Physiotherapy group|"Psychological program: 4 sessions,2 hours each,4 months
~Psychoeducation.Influence of psychological factors on chronic pain: modulators of pain experience. Biopsychosocial model of pain.
~Training techniques of psychological management of pain:Diaphragmatic Breathing and Progressive Muscle Relaxation to control vicious circle pain-tension-pain.
~Kinesiophobia. Rational regulation of the activity level:Cognitive therapy (management of irrational believes about pain) and Organisation of time and reinforcement activities.
~Physiotherapy program:3 sessions per week,1 hour per session,4 months:
~Aerobic exercise:walking, cycling
~Warm-up: active ROM exercises of inferior and superior extremities (ISE)
~Progressive resistance training with elastic bands of ISE
~Stretching of ISE"
15915769|NCT03529474|Other|Placebo comparator: control group|Control group Normal daily activities Usual daily activities
15915770|NCT03529461|Device|Non-invasive positive pressure ventilation through nasal mask|Inspiratory pressure 12 cm H2O/Expiratory pressure 6 cm H2O which can be increased to meet a tidal volume (TV) of 300-800 mL (target is 450-500), with maximum Inspiratory pressure 18 cm H2O /Expiratory pressure 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range, the pressure will be adjusted by 1-2 cm H2O) accordingly
15915771|NCT03529461|Device|Rescue non-invasive positive pressure ventilation through nasal mask|If desaturation below 90 %, nasal cannula removed and non invasive positive pressure nasal mask connected to machine: Inspiratory pressure 12 cm H2O/Expiratory pressure 6 cm H2O which can be increased to meet a tidal volume (TV) of 300-800 mL (target is 450-500), with maximum Inspiratory pressure 18 cm H2O /Expiratory pressure 8 cm H2O on 100% FiO2.If TVs are more or less than 300 to 800 mL range, the pressure will be adjusted by 1-2 cm H2O) accordingly
15915772|NCT03529461|Other|Secondary rescue maneuvers|If rescue non invasive positive pressure maneuver attempted (including adjustments in pressure) and O2 sat is not above 90 % within 3 min of starting non invasive positive pressure, scope removed and secondary rescue maneuver started. Secondary rescue maneuvers performed at the discretion of the anesthesiologist (chin lift, oral airway, bag mask, nasal trumpet, LMA, intubation). If sat > 90 % with secondary rescue maneuvers, resumption of scope exam to the discretion of anesthesia. If sat does not increase > 90 % with secondary rescue maneuvers, scope exam to be cancelled and patient care per anesthesiologist
15915773|NCT03529448|Drug|TN-TC11G|"TN-TC11G dose will be gradually increased as follows:
~Week 1: TN-TC11G: 0-0-5 mg (THC 5 mg + CBD 5 mg; in the mornings, 90 minutes after breakfast; in the afternoons, 90 minutes after lunch; in the evenings, 90 minutes after dinner).
~Week 2: TN-TC11G: 5-0-5 mg Week 3: TN-TC11G: 5-5-5 mg Week 4: TN-TC11G: 5-5-10 mg Week 5: TN-TC11G: 5-5-15 mg Week 6: TN-TC11G: 10-10-15 mg Week 7: TN-TC11G: 10-10-20 mg. Week 8: TN-TC11G: 15-15-30 mg Week 9: TN-TC11G: 20-20-40 mg TN-TC11G will be administered daily at the relevant dose level according to the individual titration performed in the first 9 weeks of treatment. If there is any dose reduction, the reduced dose must be administered."
15915774|NCT03529448|Drug|Temozolomide Oral Product|"During RT, patients will receive Temozolomide (TMZ). All patients will be given TMZ at 75 mg/m2/d concurrently with RT for a maximum of 42 days.
~At 4 weeks after RT completion, patients will start taking TMZ at 150 mg/m2/d for the first 5 days of a 28-day cycle. If first cycle is well tolerated, patients will receive TMZ at 200 mg/m2/d for the first 5 days of every subsequent 28-day cycle for another 5 cycles."
15915775|NCT03529448|Radiation|Radiotherapy|All the patients will receive the Stupp regimen. The radiotherapy (RT) treatment will be administered in fractions of 1.8-2.0 Gy/day delivered 5 days/week to a total dose of 58-60 Gy. Radiotherapy will be delivered to the gross tumor volume with a 2-3 cm margin for the clinical target volume.
15915776|NCT03529435|Behavioral|Massed Prolonged Exposure|Participants will complete fifteen weekday 90-minute Prolonged Exposure therapy sessions over three consecutive weeks. If necessary, the treatment window may be extended for another week.
15915777|NCT03529435|Behavioral|Intensive Outpatient Prolonged Exposure|The IOP-PE will include the same primary treatment components as the Massed-PE protocol (fifteen weekday 90-minute PE sessions delivered five days a week over a three-week period) plus eight augmentations designed to maximize treatment outcomes. Similar to the Mass-PE, participants will have three consecutive weeks to complete treatment; however, the treatment window may be extended another week if necessary.
15915778|NCT03529422|Drug|Durvalumab|Durvalumab 1500mg IV every 3 weeks for 6 cycles
15915779|NCT03529422|Radiation|Intensity Modulated Radiotherapy Treatments|Total dose will be 60 Gray (Gy) at 2Gy per fractions for 30 fractions delivered Monday through Friday for 6 weeks
15915780|NCT03529409|Behavioral|Project Khanya|This treatment involves integrating a behavioral intervention for substance use with a behavioral intervention for adherence.
15915781|NCT03529396|Drug|Chloroquine|Standard chloroquine (three days)
15915782|NCT03529396|Drug|Primaquine|Daily Primaquine (0.5 mg of base/kg/day for seven days) starting only at the fifth day post chloroquine initiation.
15915783|NCT03529396|Drug|Primaquine|Weekly primaquine (0.75 mg of base/kg/week for eight weeks) starting with first dose of chloroquine.
15915784|NCT03529396|Drug|Chloroquine|Weekly, once a week chloroquine (5 mg of base/kg/week for twelve weeks)
15915786|NCT03529383|Device|Connected device|Women will receive a connected wristband (https://www.carefitness.com/) and a subscription to a smartphone application and website (http://disco.biomouv.com/). They will have to participate in a 6-month personalized non-supervised exercise program consisting of 3 weekly sessions of 20 min to 1-hr of moderate-to-vigorous physical activity (≥3 METs): 2 sessions of brisk walking and 1 session of muscle strengthening. Women should wear the wristband daily to track their number of steps (automatic Bluetooth synchronization to the application). Duration and intensity of sessions and target number of daily steps will progressively increase (+15% up to 10,000 steps) to place the patients in a progression dynamic. Women will receive phone-based follow-up at 1 week, 2 months, and 4 months.
15915787|NCT03529383|Behavioral|Therapeutic education|"Women will be invited to participate in the 6-month therapeutic patient education program Mieux manger, mieux bouger (Eat better, move better) elaborated at the Léon Bérard cancer center. The program consists in four sessions:
~a 1-hour individual session of educational diagnosis to assess their needs and establish a contract of objectives,
~two educational sessions of 1h30 each using tools, in group of 10 patients maximum to improve their daily practice of physical activity,
~a 1-hour individual session of educational assessment to evaluate whether their objectives were reached."
15915788|NCT03529370|Radiation|optic nerve ultrasound|sonograhy of the optic nerve sheath diameter
15915789|NCT03529344|Dietary Supplement|Blue whiting protein hydrolysate|Dietary Supplement: Blue whiting protein hydrolysate 6g protein per day for 6wk
15915790|NCT03529344|Dietary Supplement|Placebo Comparator: Control|Control group will receive non-caloric juice without protein supplementation
15915791|NCT03529331|Drug|Morphine Sulfate Immediate Release|15 mg Morphine Sulfate Immediate Release (MSIR) tablet 4 times a day for 5 days
15915792|NCT03529331|Drug|Oxycodone/Acetaminophen|5 mg of Oxycodone/Acetaminophen (Percocet) tablet 4 times a day for 5 days
15915793|NCT03529331|Drug|Hydrocodone/Acetaminophen|5 mg of Hydrocodone/Acetaminophen (Vicodin) tablet 4 times a day for 5 days
15915794|NCT03529318|Procedure|Biopsies from endoscopy|"1) Patients scheduled for endoscopy (EGD or colonoscopy) for IBD will be consented to allow physicians who are performing endoscopies to take additional biopsies and blood samples for research purposes."
15915795|NCT03529305|Device|rTMS|Receive rTMS treatment to the primary motor cortex (M1)
15915796|NCT03529305|Other|Physical therapy|Receive physical therapy
15915797|NCT03529292|Device|AmeaCell|Lipoaspirate obtained from liposuction is treated by the AmeaCell® device in order to obtain de modified matrix which contains cellular phase and matrix phase. The modified matrix is injected in the same patient as facial wrinkles filler.
15915798|NCT03529279|Drug|CNG Chemotherapy|"CNG I, IMRT plus oral adjuvant chemotherapy, if EBV-DNA > 0,according to CNG II. CNG II, IMRT + concurrent chemotherapy + oral adjuvant chemotherapy. CNG III, systemic chemotherapy, plus IMRT.
~Chemotherapy strategy: Concurrent chemotherapy, 5-Fu + nedaplatin (cisplatin), every 28 days; 5-Fu 500mg/m2. D, civ d1-d5, nedaplatin (cisplatin) 80mg (70mg) /m2. D, D1. Systemic chemotherapy, 5-Fu + nedaplatin (cisplatin), every 60 days; 5-Fu (100 - 200 mg/m2. D) civ for 30 days, nedaplatin (cisplatin) 80mg (70mg) /m2. D, D1,D28. Aim to achieve CR in imaging.Oral adjuvant chemotherapy, tegafon (400 mg, QID) and Calcium Folinate Tablets (30 mg, QID). Oral 10 days and stop 20 days, 3 months/course. After 6 courses, oral 10 days and stop 50 days, half year/course, 6-7 courses, lasted for 5 years."
15915799|NCT03529279|Drug|NCCN Chemotherapy|"UICC I, IMRT. UICC II-IVA, concurrent chemoradiotherapy ± adjuvant chemotherapy, or induced chemotherapy plus concurrent chemoradiotherapy. UICC IVB, platinum based combined chemotherapy, followed by IMRT or concurrent chemoradiotherapy, or concurrent chemoradiotherapy.
~Chemotherapy strategy: Concurrent cisplatin with or without cisplatin plus 5-Fu or carboplatin combined with 5-Fu adjuvant chemotherapy; The combined chemotherapy regimen of IVB stage patients may choose cisplatin or carboplatin plus docetaxel or paclitaxel, cisplatin plus 5-Fu, carboplatin and cetuximab, cisplatin plus gemcitabine, and gemcitabine. The combination of vinorelbine and cisplatin, carboplatin, paclitaxel, docetaxel, 5-Fu, methotrexate, gemcitabine and capecitabine can be used in combination with radiotherapy."
15915800|NCT03529279|Radiation|CNG Radiation|"IMRT technique. GTV was given to 6810cGy, CTV1 was given to 6000cGy, and CTV2 was given to 4800-5400cGy. 30 fractions, daily, QW1-5.
~CT-SIM or MR-CIM was evaluated every 10 fractions. If CR for CNG I and II patients at 10 fractions, radiotherapy were given 25 fractions, that was, GTV was given to 5675cGy, CTV1 was given 5000cGy, and CTV2 was given 4000-4500cGy, 25 fractions, daily, QW1-5.
~If tumor reduced less than 50% at 20 fractions, GTV was modified according to tumor size at 20 fractions. The modified GTV was given 300cGy/F×5 after 25 fractions; the original CTV1 and CTV2 were unchanged, that is, GTV was given to 5675cGy/25Fr+1500cGy/5Fr and CTV1 was given to 6000cGy/30Fr, CTV2 was given 4800-5400cGy/30Fr."
15915801|NCT03529279|Radiation|NCCN Radiation|"IMRT technique. When IMRT alone, GTV were given (1) 66Gy (2.2Gy/Fr) to 70-70.2 Gy (1.8-2.0 Gy/Fr), QW1-5, 6-7 weeks; (2) 69.96 Gy (2.12 Gy/Fr), 6-7 weeks; CTV1-2 were given 44-50 (2.0 Gy/Fr) to 54-63 (1.8 Gy/Fr).
~When combined with chemotherapy, GTV were given 70-70.2 Gy (1.8-2.0 Gy/Fr), QW1-5, 7 weeks; CTV1-2 were given 44-50 Gy (2 Gy/Fr) to 54-63 Gy (1.8 Gy/Fr).
~When palliative radiotherapy, 50Gy/20Fr; 37.5 Gy/15Fr (if tolerable, increases 5 fractions to 50Gy); 30Gy/10Fr, 30Gy/5Fr, 2 fractions per week, interval more than 3 days; 44.4Gy/12Fr was divided into 3 cycles, 2 fractions a day, 6 hours of interval, 2 consecutive days and 3-4 weeks between two cycles. After second cycles, the treatment plan must completely avoid the irradiation of the spinal cord."
15915802|NCT03529266|Biological|Porcine Fibrin Sealant (PFS)|2.5ml Porcine Fibrin Sealant will be instilled over the cervical anastomose line.
15915803|NCT03529266|Procedure|Surgery|McKeown esophagectomy including open or minimally invasive esophagectomy will be performed for patients with resectable thoracic esophageal carcinoma or gastroesophageal junction cancer. Two-field lymphadenectomy with total mediastinal lymph node dissection is performed during surgery. At last, 2.5ml Porcine Fibrin Sealant will be instilled over the cervical anastomose line.
15915804|NCT03529253|Drug|Alirocumab 75 MG/ML [Praluent]+ Rosuvastatin 10mg/daily|Alirocumab group receive Alirocumab75mg/2week subcutaneous injection plus Rosuvastatin10mg/daily by oral for 9 months.
15915805|NCT03529253|Drug|Rosuvastatin calcium10mg|Rosuvastatin10mg/daily by oral for 9 months.
15915850|NCT03528902|Drug|Placebo Oral Tablet|Placebo
15915851|NCT03528889|Procedure|Femoral Extension and Derotation Osteotomy (ExtFDO)|Correction of malrotation of the femoral bone and flexed knee gait by osteotomy, derotation and osteosynthesis
15915852|NCT03528876|Drug|FOLFOX and FOLFIRI|a biweekly regimen comprised of two cycles of FOLFOX alternating with two cycles of FOLFIRI.
15915807|NCT03529214|Behavioral|Exposed study site|The study sites will pilot the Team Birth Project designed to improve team communication (between providers, as well as providers and patients). The project includes three key implementation steps that involve: preparing local sites for the implementation of the project; training and coaching on the use of the tools; and sustainment through peer coaching and data feedback. A mixed methods approach will be used to assess acceptability and feasibility, including: (1) clinician surveys and interviews, (2) implementation team focus groups, and (3) patient surveys.
15915808|NCT03529201|Procedure|QLB|On the side of the surgery, QLB with 0.375% ropivacaine (0.2 mL/kg)
15915809|NCT03529201|Device|PCA|Patient-controlled analgesia
15915810|NCT03529201|Procedure|GA|General anesthesia
15915811|NCT03529201|Drug|Oxycodone|administered by PCA
15915812|NCT03529201|Drug|Sevoflurane|Inhalational anesthetic during GA
15915813|NCT03529201|Drug|Fentanyl|painkiller during GA
15915814|NCT03529201|Drug|Rocuronium|muscle relaxant during GA
15915815|NCT03529175|Drug|Abraxane (nab-paclitaxel)|
15915816|NCT03529175|Drug|Gemcitabine|
15915817|NCT03529162|Procedure|Long head of Biceps Tenodesis|Patients will be randomized into two different groups to compare biceps tenodesis techniques
15915818|NCT03529149|Combination Product|Urapidil Hydrochloride Injection|"Accurate monitoring of blood pressure is carried out under TCD monitoring, that is to maintain （mean flow velocity）MFV or （pulse index）PI target blood pressure. The target values of MFV and PI are MFV>37cm/s of （middle cerebral artery)MCA, PI < 1.34cm/s, aMFV>40cm/s of (basilar artery)BA, PI < 0.8cm/s.
~TCD shows that when the MFV of MCA or BA is lower than the target value, the blood pressure is reduced or discontinued according to the insufficiency of blood flow. and the current blood pressure is maintained once MFV is met. TCD showed that the PI index of MCA or BA was higher than the target value . The blood pressure reduction was treated by excessive perfusion: intravenous infusion of blood pressure drugs , once PI index is up to the standard, maintaining the current blood pressure."
15915819|NCT03529136|Biological|UC-MSC|Human umbilical cord mesenchymal stem cells have driven from Wharton's jelly and cultured with serum-free medium in Shandong Cell and tissue bank. All of the cells in this study within three passages. Before transfusion, the mesenchymal stem cells were subjected to quality control. The UC-MSC were stained with anti-CD90-FITC, Anti-CD44-FITC, Anti-CD34-FITC and anti-45-FITC.
15915820|NCT03529123|Drug|INSULIN GLARGINE/LIXISENATIDE (HOE901/AVE0010)|"Pharmaceutical form: Injection
~Route of administration: Subcutaneous"
15915821|NCT03529123|Drug|INSULIN GLARGINE (HOE901)|"Pharmaceutical form: Injection
~Route of administration: Subcutaneous"
15915822|NCT03529123|Drug|Metformin|"Pharmaceutical form: Tablet
~Route of administration: Oral"
15915823|NCT03529123|Drug|Insulin Glulisine (HMR1964)|"Pharmaceutical form: Injection
~Route of administration: Subcutaneous"
15915824|NCT03529110|Drug|Trastuzumab deruxtecan (DS-8201a)|DS-8201a is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered intravenously
15915825|NCT03529110|Drug|Ado-trastuzumab emtansine (T-DM1)|The treatment will be in accordance with the approved label
15915826|NCT03529097|Drug|0.9% Sodium-chloride|2 liters of 0.9% NaCl IV fluids
15915827|NCT03529097|Drug|Placebos|2 liters of 0.9% NaCl bag covered with black bag so the participant could not tell the fluids are not dripping to his vain
15915828|NCT03529097|Drug|Optalgin, Voltaren, Morphine|Oral and IV Optalgin, Voltaren IM (intramuscular), Morphine IV. All according to the pain intensity and with concordance to the physician.
15915829|NCT03529084|Drug|EFG816|It will be administered orally daily.
15915830|NCT03529084|Drug|erlotinib or gefitinib|"Investigator's choice between erlotinib or gefitinib. These will be locally sourced.
~Erlotinib will be administered orally daily. Gefitinib will be administered orally daily."
15915831|NCT03529071|Behavioral|CKD-Question Prompt Sheet|The CKD-QPS is a list of 31 questions specific to CKD stage 3 patients about treatment options and self-care management designed to activate patient communication with their providers and question-asking.
15915832|NCT03529045|Device|Vagus Nerve Stimulation (VNS) Therapy|The VNS Therapy System is a commercially available device that will be used by licensed medical practitioners trained in the use of VNS Therapy, per the practitioners' medical judgement.
15915833|NCT03529032|Drug|Methadone|methadone for control postoperative pain
15915834|NCT03529019|Drug|Ensure Surgery Immunonutrition Shake|An FDA approved nutritional supplement. Prepackaged product designed to be administered one week prior to and one week post surgical procedures.
15915835|NCT03529019|Drug|Ensure Enlive Advanced Nutrition Shake|An FDA approved nutritional supplement. Prepackaged product designed to be administered 2 weeks prior to and 2 weeks post surgical procedure for a period of one week. .
15915836|NCT03529006|Procedure|Sequent Please inflation|PCI procedure for treatment of ISR with DEB - Sequent Please - inflation
15915837|NCT03529006|Procedure|Absorb BVS implantation|PCI procedure for treatment of ISR with Absorb BVS implantation
15915838|NCT03528993|Other|exercise by hippotherapy device|Hippotherapy device mostly used on cerebral palsy, but we want to use hippotherapy device on patient with Hemiplegia.
15915839|NCT03528993|Other|conventional rehabilitation|Bobath exercises: Bobath is a type of physiotherapy treatment which aims to improve movement and mobility in patients with damage to their central nervous system (brain and spinal cord).
15915840|NCT03528993|Other|postural control exercises|perturbation on four directions, weight bearing exercises on standing positions
15915841|NCT03528967|Drug|Enoxaparin 40 mg / 0.4 mL Prefilled Syringe|
15915842|NCT03528967|Drug|Aspirin 100 mg Oral Tablet, Enteric Coated|
15915843|NCT03528954|Drug|Propofol|Those who received intravenous propofol
15915844|NCT03528941|Drug|Lamivudine|Patients who received lamivudine to prevent hepatitis B
15915845|NCT03528941|Other|No prophylaxis|Patients who did not receive any prophylaxis to prevent hepatitis B
15915846|NCT03528928|Device|Surface electrical stimulation|Thin electrode with four conductive areas placed over the perineal area.
15915847|NCT03528915|Other|Rifamycine treatment|Phone prospecting: occurrence of conjunctivitis in newborns treated with rifamycine treatment in delivery room.
15915848|NCT03528915|Other|whithout Rifamycine treatment|Phone prospecting: occurrence of conjunctivitis in newborns did not receive eye drop treatment in delivery room according to new guidelines.
15915849|NCT03528902|Drug|Tamoxifen|Tamoxifen 20 mg po daily for 24 weeks.
15915855|NCT03528850|Other|Telemedicine evaluation|Weekly virtual visits and daily biometric readings of blood pressure, weight, oxygen saturation and pulse
15915856|NCT03528824|Other|Fenugreek wrap|Daily application of fenugreek wraps for 1/2-2 hours per day, 4 weeks application
15915857|NCT03528824|Drug|Diclofenac Gel|Daily application of diclofenac gel, 4 weeks application
15915858|NCT03528811|Diagnostic Test|Five points test of Tongji university|"In each group, we will evaluate the microcirculation of diabetic foot using the newly-established Five points test of Tongji university before or after the operation, and then compare the temperature of the five points with the other data."
15915859|NCT03528785|Drug|Irinotecan Liposomal Injection [Onivyde]; oxaliplatin, 5-FU; Levofolinic Acid|"Oxaliplatin 60 mg/m2 IV in 120 minutes) on Days 1 and 15 of each cycle
~Irinotecan Liposomal Injection [Onivyde] (60 mg/m2 IV over 90 minutes) on Days 1 and 15 of each cycle
~Levofolinic acid (200 mg/m2 IV over 30 minutes) on Days 1 and 15 of each cycle
~5FU (2.400 mg/m2 IV over 46 hours) on Days 1 and 15 of each cycle"
15915860|NCT03528772|Drug|Minoxidil|application of minoxidil forte 5% gel three time per day on the anus for four weeks
15915861|NCT03528772|Drug|Glyceryl trinitrate|application of glyceryl trinitrate 0.2% cream three time per day on the anus for four weeks
15915862|NCT03528746|Other|Isotonic Exercise|Participants will complete dynamic leg extension in a leg extension machine with a range of motion from approximately 90 degrees flexion to full extension. Each repetition will be completed with a 3s concentric contraction, 0s isometric and 4s eccentric contraction.This will be repeated for 8 repetitions and for 5 sets with 2 minutes rest between each set, as per Rio and colleagues. The load used during the isotonic exercise will be equivalent to participants 8 repetition maximum, which will be determined by an experienced tester in a standardised manner according to NSCA guidelines.
15915863|NCT03528746|Other|Isometric exercise|Participants will complete isometric quadriceps exercise, where they must hold a load statically for 45s with their knee in 60° flexion. This will be repeated for 5 sets with 2 minutes rest between each set. A load of 70% of the maximal voluntary isometric contraction (MVIC) will be used. MVIC will be assessed in an isokinetic dynamometer as per Rio and colleagues. Participants will be seated in a stable position in the dynamometer with the knee at 60° of knee flexion. First they will be familiarised with the procedure. Standardised instructions will be issued for participants to perform a maximal effort knee extension against the dynamometer for 3seconds. After a short break, the test will be repeated three times and the MVIC will be peak torque recorded during these three efforts.
15915864|NCT03528733|Device|Multi-Energy Digital Radiography Detector System|A Multi-energy digital flat panel detector for Single Exposure Dual-Energy Subtraction radiography is developed to capture x-ray images with improved tissue differentiation. Tissue-selective images can be produced at various tissue levels such as bone and soft tissue to visualize obscured anomalies that are not apparent to General Radiography.
15915865|NCT03528707|Dietary Supplement|Symbiter-Omega|"Symbiter Omega which contains combination of flax and wheat germ oil (250 mg of each, concentration of omega-3 fatty acids 1-5%), supplemented with biomass of 14 alive probiotic strains: Lactobacillus + Lactococcus (6×1010 CFU/g), Bifidobacterium (1×101"
15915866|NCT03528707|Dietary Supplement|Placebo|Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) of gel per day
15915867|NCT03528694|Biological|Durvalumab (MEDI4736)|Investigational product
15915868|NCT03528694|Biological|Bacillus Calmette-Guerin (BCG)|Standard of care
15915869|NCT03528681|Drug|Sodium Zirconium Cyclosilicate 5g|Suspension administered Sodium Zirconium Cyclosilicate 5g orally once daily for 28 days after the open label initial phase with suspension administered Sodium Zirconium Cyclosilicate 10g orally three times per day for at most 2 days.
15915870|NCT03528681|Drug|Sodium Zirconium Cyclosilicate 10g|Suspension administered Sodium Zirconium Cyclosilicate 10g orally once daily for 28 days after the open label initial phase with suspension administered Sodium Zirconium Cyclosilicate 10g orally three times per day for at most 2 days.
15915871|NCT03528681|Drug|Placebo|Suspension administered orally placebo once daily for 28 days after the open label initial phase with suspension administered Sodium Zirconium Cyclosilicate 10g orally three times per day for at most 2 days.
15915872|NCT03528668|Device|Virtual Reality Exposure|Exposure to Virtual Reality program for up to 30 minutes
15915873|NCT03528655|Other|Decision aid|Decision aid is a tool that helps pregnant women become involved in decision making on choosing rooming-in or separation care. Decision aid provides information about the options and outcomes, and by clarifying personal values.
15915878|NCT03528629|Drug|Zolbetuximab|Zolbetuximab will be administered as a 2-hour intravenous infusion.
15915879|NCT03528616|Drug|adenosine,Propranolol,flecainide, amiodarone, propranolol, digoxin and procainamide.|drugs used for treatment of supraventricular tachycardia
15915880|NCT03528603|Other|Oleocanthal-Rich Extra Virgin Olive Oil|Extra Virgin Olive Oil that contains a high level of the phenolic oleocanthal
15915881|NCT03528603|Other|Oleocanthal-low Extra Virgin Olive Oil|Extra Virgin Olive Oil that contains a low level of the phenolic oleocanthal
15915882|NCT03528590|Device|size 3 i-gel supraglottic airway device|Use size 3 i-gel® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery.
15915883|NCT03528590|Device|size 4 i-gel supraglottic airway device|Use size 4 i-gel® in anesthetized, paralyzed female patients weighing 50 to 60 kilograms who undergo breast surgery.
15915884|NCT03528577|Drug|Zero-dose|Treatment A
15915885|NCT03528577|Drug|90 mcg of PROAIR® HFA|Treatment B
15915886|NCT03528577|Drug|180 mcg of 90 mcg of PROAIR® HFA|Treatment C
15915887|NCT03528577|Drug|90 mcg of albuterol sulfate inhalation aerosol|Treatment D
15915888|NCT03528564|Drug|Iron sucrose|Intravenous iron to be administered to all patients (9 x 5 mL Single Dose Vials @ 20mg elemental iron/mL; 900 mg total)
15915889|NCT03528564|Drug|Epoetin Alfa|Erythropoietin to be administered to half of study participants (40,000 IU x 1-2 subcutaneous injections)
15915890|NCT03528564|Drug|Placebo|Saline to be administered to half of study participants (equal volume to Eprex x 1-2 subcutaneous injections)
15916077|NCT03527147|Drug|AZD5153|AZD5153 will be administered orally once per day (qd).
15915891|NCT03528551|Drug|Turoctocog alfa pegol|Turoctocog alfa pegol 75 IU/kg body weight will be administered once weekly as intravenous injections for a duration of 2 years.
15915892|NCT03528551|Drug|Turoctocog alfa pegol|Turoctocog alfa pegol 60 IU/kg body weight (for patients younger than 12 years) and 50 IU/kg body weight (for patients, 12 years or older) will be administered twice weekly as intravenous injections for a duration of 2 years.
15915893|NCT03528551|Drug|Turoctocog alfa pegol|Turoctocog alfa pegol 50 IU/kg body weight will be administered three times weekly as intravenous injections for a duration of 2 years.
15915894|NCT03528538|Dietary Supplement|AlphaFen fenugreek 400 mg|A brand of fenugreek supplementation that was produced by SPECNOVA. Pure fenugreek without any additives.
15915895|NCT03528538|Dietary Supplement|AlphaFen fenugreek 500 mg|A brand of fenugreek supplementation that was produced by SPECNOVA. Pure fenugreek without any additives.
15915896|NCT03528538|Other|Placebo|rice flour in a vegetable/ cellulose capsule
15915897|NCT03528512|Drug|Ketamine|Intranasal ketamine 3mg/kg (max 100 mg) + saline 0.03 ml/kg (max 2ml)
15915898|NCT03528512|Drug|Midazolam and fentanyl|Intranasal midazolam 0.3 mg/kg (max 10 mg) + fentanyl 1.5mcg/kg (max 100 mcg)
15915899|NCT03528499|Other|Scapular Movement Training|Orientation about the proper scapular position and movement and training to modify the scapular movement pattern.
15915900|NCT03528499|Other|General Exercises|Strengthening and stretching exercises.
15915901|NCT03528486|Behavioral|Music Training I|Participants will be attending group classes, guided by a trainer, with up to 10 other older adults.
15915902|NCT03528473|Other|Exercise|"The exercise intervention consists of 60 minutes sessions, divided into 40 minutes of aerobic exercise and 20 minutes of circuit training for muscular strength and flexibility exercises.
~Aerobic exercise is performed using treadmill, exercise bikes, syncro and arm-ergometers, gradually increasing the exercise intensity, after a 10 minutes period of warming-up, to 60-80 % of Maximum Heart Rate.
~Resistance training consists of resistance exercises for large muscle groups, performed with body weight-exercises and isotonic machines."
15915904|NCT03528434|Dietary Supplement|Zinc|10mg dispersible zinc sulfate tablet
15915905|NCT03528434|Other|Placebo|Dispersible tablet with inert ingredients, identical to zinc in appearance
15915906|NCT03528421|Biological|IM19|CAR-T cells
15915907|NCT03528421|Drug|Fludarabine|Two days before cell infusion, all patients will be treated with fludarabine for 3 days
15915908|NCT03528421|Drug|Cyclophosphamide|Two days before cell infusion, all patients will be treated with Cyclophosphamide for 3 days
15915911|NCT03528395|Other|Semi-immersive virtual reality|Each participant will receive 24 additional sessions of semiinmersive virtual Reality therapy sessions on Monday, Wednesday and Friday, after realizing the conventional therapy sessions. The duration of each VR session will be gradually increased in time-intensity (5 minutes during the first week to 20 minutes during the last week) and motor requirements.
15915912|NCT03528395|Other|Conventional Rehabilitation|Conventional rehabilitation consisting of five weekly sessions of Physical therapy and Occupational Therapy, based on a task-oriented approach, lasting 45 minutes each.
15915913|NCT03528382|Behavioral|Cardiac rehabilitation quality improvement system|Cardiac rehabilitation quality improvement system is divided into two period. The period I of rehabilitation has three parts, including daily life, rehabilitation exercise training, publicity and education. And the period II of rehabilitation is based on aerobic exercise, as well as combined with resistance and flexibility exercises
15915914|NCT03528369|Drug|CGS-200-1|CGS-200-1 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 1% for this study.
15915915|NCT03528369|Drug|CGS-200-5|CGS-200-5 is a multi-component formulation in which the active ingredient for the intended therapeutic effect is capsaicin at a level of 5% for this study.
15915916|NCT03528369|Drug|CGS-200 Vehicle|CGS-200 Vehicle contains all of the ingredients in CGS-200-1 and CGS-200-5 except for capsaicin.
15915917|NCT03528356|Behavioral|Regular diet|Patients will not receive any information regarding their usual diet. They will simply perform home dental bleaching.
15915918|NCT03528343|Drug|Non-narcotic pain control|Education to use tylenol and motrin only for pain control unless this is unable to control pain. Rescue prescription provided.
15915919|NCT03528330|Device|Rehabilitation with dental implant with internal hexagon connection|"All patients will receive an implant with internal hexagon connection. All implants will be10 mm in length and 3.75 mm in diameter. Implants will be inserted slightly subcrestal. Bone levels will be measured using a calibrated probe.
~Torque insertion will be assed using W&H machine Once inserted, implants will be connected to smart pegs to test primary stability.
~A periapical x-ray will be done after the operation. Thereafter, a specific coping for digital impression will be connected to the implant and a digital impression will be taken. Aim of this procedure will be to produce a screw retained definitive zirconia prosthesis to be adapted at the time of second surgery"
15915920|NCT03528330|Device|Rehabilitation with dental implant with conical connection|"All patients will receive an implant with conical connection. All implants will be10 mm in length and 3.75 mm in diameter. Implants will be inserted slightly subcrestal. Bone levels will be measured using a calibrated probe.
~Torque insertion will be assed using W&H machine Once inserted, implants will be connected to smart pegs to test primary stability.
~A periapical x-ray will be done after the operation. Thereafter, a specific coping for digital impression will be connected to the implant and a digital impression will be taken. Aim of this procedure will be to produce a screw retained definitive zirconia prosthesis to be adapted at the time of second surgery"
15915921|NCT03528317|Other|Alternate day fasting|Alternate day fasting with a high protein diet
15915922|NCT03528304|Behavioral|Contingency management|Contingency management (CM) is a behavioral intervention that uses gift cards, prizes, or access to privileges to reinforce specific healthy behaviors and lifestyle changes. CM has been used successfully for a range of addictive behaviors, including cigarette smoking and heroin, cocaine, methamphetamine, and other illicit substance use, as well as for reducing psychiatric problems and HIV risk. CM has great potential for treating smoking and overweight/obesity, as it reinforces both short- and long-term behaviors. This is important because both smoking cessation and weight loss are highly prone to short-term relapse,
15915923|NCT03528278|Behavioral|Motivational interviewing and environmental interventions|"Revision of ward routines towards facilitating physical activity in patients and motivational work by staff
~Education of staff with certified MI-expert organized as an intensive course and follow-up guidance. The first course held shortly before start of interventions, the rest arranged within a month
~Training equipment
~Motivational Interviewing (MI) techniques applied by staff
~Weekly treatment plans including physical activity which may consist of any continuous physical exercise."
15915924|NCT03528265|Device|Lateral flow immunoassay|Biospecimens of patients with melioidosis-like symptoms will be tested with lateral flow immunoassay to detect Burkholderia pseudomallei, bacterium causing melioidosis
15915925|NCT03528252|Other|Written advice LDL Cholesterol|One A4 paper with written information on both sides
15915926|NCT03528252|Other|Written advice Triglycerides|One A4 paper with written information on both sides
15915927|NCT03528239|Other|Refugee patients|To investigate characteristics of outpatient visits of refugee patients
15915928|NCT03528226|Behavioral|Exercise Training Procedure|Exercise training: 3 sessions - 2 supervised and 1 unsupervised - per week of 30-60 min at 65% - 80% of maximum heart rate (4 months)
15915929|NCT03528226|Behavioral|Normal life procedure|No supervised exercise training during the 4 month period.
15915930|NCT03528213|Drug|Sodium Lactate light dose|bolus 2.5ml/kg then 0.25ml/kg/h
15915931|NCT03528213|Drug|Sodium Lactate high dose|bolus 2.5ml/kg then 0.5ml/kg/h
15915932|NCT03528213|Drug|Normal saline|normal saline at physician discretion
15915933|NCT03528200|Other|Contrast|"The scan requires that the patient lie still on a hard surface for about 5-10 minutes. Before the scan, they will have a special fluid called contrast dye injected through the IV in their arm. This contrast dye helps to see the blood in the arteries using x-ray pictures.
~After the IV dyna CBV is completed, they will have their routine conventional angiography to evaluate the lesion for embolizable arteries as part of routine clinical care. If the patient undergoes embolization of the lesion (as part of the standard of care), a post embolization Dyna CBV will be performed."
15915934|NCT03528187|Other|MRI|"MRI scan (not involving ionising radiation)
~The MRI study will be conducted by a trained MR radiographer, supervised by the nominated researcher"
15915935|NCT03528187|Other|Written Consent|Student researcher or research nurses to take consent. Consent will be taken in the obesity clinic or radiology departments.
15915936|NCT03528174|Device|Artificial Pancreas Control system (APC)|This intervention is a single hormone closed loop system including a Nexus 5 smart phone, two tslim insulin pumps, a Dexcom G5 CGM and two PDT glucose sensing cannulas that together make up a new experimental, investigational device system. The algorithm included in the APC is an automated version of the Fading Memory Proportional Derivative (FMPD) insulin and glucagon control algorithm.
15915937|NCT03528174|Device|Pacific Diabetes Technologies CGM Insulin Infusion system|An integrated combination CGM/insulin infusion system
15915938|NCT03528161|Other|Measurement of hypersensitive troponin|"Telephone follow-up at one month, 3 months and 6 months by a clinical research technician. Collection of serious adverse events, reports of hospitalization.
~The hypersensitive troponin assay will be recently proposed in a short-term risk stratification score after syncope (30 days), the canadian syncope risk score. If hypersensitive troponin benefits from interesting performances it needs to be evaluated prospectively, as measured only in 47.9% of syncope in this study. Hypersensitive troponin could be a prognostic marker of early serious adverse cardiovascular events in syncope."
15915939|NCT03528148|Behavioral|cycling|Active cycling
15915940|NCT03528148|Behavioral|Physical therapy|Conventional physical therapy
15915941|NCT03528135|Behavioral|Project PRIDE|See arms section.
15915942|NCT03528122|Procedure|Recurrent opened macular hole|pars plana vitrectomy + internal limiting membrane peeling + Amniotic membrane graft placement over the hole + intraocular tamponade
15915943|NCT03528109|Behavioral|Exposure Therapy|A type of Cognitive Behavioral Therapy shown to be effective in the treatment of pediatric OCD and anxiety
15915944|NCT03528096|Device|Somnomat B|Vestibular stimulation is provided using an innervated bed platform. This robotic device consists of a standard single bed, mounted on a moving mechanism. It was developed and produced by the ETH Zürich and approved for use in this study by Swissmedic.
15915945|NCT03528096|Other|Sound|Sound of the moving bed was recorded and played back during the baseline night.
15915946|NCT03528083|Other|Bronchiolitis quality improvement|Patients in the intervention group will undergo a quality improvement process to improve care quality for bronchiolitis at our hospital.
15915947|NCT03528070|Drug|Tranilast|Subjects will be treated with tranilast
15915948|NCT03528057|Device|Hemostat|Hemostatic agents, if used at all during surgery, will be applied laparoscopically into the tumor bed to stop bleeding. The type of hemostat will be decided by the surgeon according to the anatomy of the tumor bed.
15915949|NCT03528044|Procedure|Bariatric surgery|In this study, patients will undergo sleeve gastrectomy to reduce the size of the stomach to induce weight loss.
15915950|NCT03528031|Other|Intervention Daily Avocado|Participants follow their usual diet and lifestyle but also are provided with 1 avocado to consume per day for 6 months.
15915951|NCT03528018|Device|REACt system|The REACt system is a virtual reality-based paradigm for upper limb rehabilitation that allows for interaction of individuals with restricted movements from active responses triggered when they attempt to perform a movement. The experimental system also provides multisensory stimulation in the visual, auditory, and tactile channels, and transcranial direct current stimulation coherent to the observed movements
15915980|NCT03527784|Device|Parietene Macro|Parietene Macro is used on retromuscular sublay position. The bowel is brought through opening in the middle of the mesh.
15915981|NCT03527784|Device|Parietex Parastomal|Parietex Parastomal is used on intraperitoneal onlay position by modified Sugarbaker technique to prevent parastomal hernia.
15915952|NCT03528018|Other|Physical therapy|Physical therapy included passive and active mobilization of the paretic upper limb. Passive range of motion exercises were provided in those segments where no active movement was detected to meticulously reproduce a range of articular movements and muscle and soft tissue elongation. In case of residual active movement capability, participants were encouraged to perform the movements with the assistance of the therapists
15915953|NCT03528005|Behavioral|Multi-domain intervention|60 minutes cognitive training, 45 minutes physical exercise, 15 diet nutrition and intermittent disease management consultation
15915954|NCT03527992|Device|O2 automated|"In the O2 automated group, patients benefit from oxygen therapy via the FreeO2 device. The O2 saturation target is set by the clinician on the device. Saturation is continuously sensed by an oximeter and the oxygen flow is automatically adjusted. The clinician has access to instantaneous values and trends of O2 and SpO2 flow rates."
15915955|NCT03527992|Device|O2 standard|"In the O2 standard group, patients benefit from oxygen therapy with nasal goggles or a high concentration mask. Saturation is continuously captured by an oximeter. The flow rate of oxygen, evaluated in L/min, is adapted according to local protocols (every 8 hours in conventional hospital services, continuous in intensive care"
15915956|NCT03527979|Procedure|IVF/ICSI|IVF/ICSI
15915957|NCT03527966|Biological|5cc Vivigen and local autograft|The single level lumbar instrumented fusion patients assigned to this group will receive 5cc Vivigen and local autograft
15915958|NCT03527966|Biological|Small kit rhBMP-2 with local autograft|The single level lumbar instrumented fusion patients assigned to this group will receive small kit rhBMP-2 with local autograft
15915959|NCT03527953|Other|Tetric EvoCeram Bulkfill|The preparation will be etched with 37% phosphoric acid. It will be then rinsed with an air-water spray and dried, leaving the dentin slightly moist. An etch-and-rinse adhesive, ExciTE F, will be applied and agitated on the prepared surfaces for at least 10 seconds. The adhesive will be air-thinned and light-cured for 20 seconds with an LED curing unit. The sectional matrix will be placed and fixed with wooden wedges. Then the bulk-fill resin composite, TBF, will be placed in bulk in about 4-mm thickness and then will be cured for 20 seconds.
15915960|NCT03527953|Other|Surefil SDR Flowable bulkfill|The preparation will be etched. A two-step etch-and-rinse adhesive, Prime&Bond NT will be applied to all enamel/dentin surfaces, air-dried for 5 seconds, and will be light cured for 10 seconds. After the sectional matrix will be placed, the flowable bulk-fill resin composite, SureFil SDR™ flow (Dentsply Caulk, Milford, DE, USA), will be placed in a 4-mm bulk increment in the dentinal part cured for 20 seconds and will be followed by a covering layer of the nanohybrid resin composite, Ceram.X Mono that will be cured for 20 seconds.
15915961|NCT03527953|Other|everX fiber-reinforced resin|The enamel will be etched with 37% phosphoric acid for 10 seconds, then will be rinsed, and dried with an air/water syringe for at least 5 seconds. Self-etch adhesive, G-aenial Bond (GC Co., Tokyo, Japan), will be applied to all enamel/dentin surfaces and gently air thinned and then will be light cured for 10 seconds. After the matrix will be placed and wedged, mesial or distal walls will be built with 1-2-mm layers of G-aenial Posterior resin composite. The fiber-reinforced composite, everX Posterior, will be placed into the cavity in approximately 4-mm thickness. The last 2 mm of the cavity will be restored using the G-aenial Posterior composite as an overlay layer. Each increment will be light cured for 20 seconds using an LED unit.
15915962|NCT03527927|Drug|Any LABA/LAMA|Following consent, patients will be taken off their current ICS/LABA/LAMA combination inhalers and shown 4 single inhaler LABA/LAMA devices and asked to choose a preferred device to use, provided they can demonstrate effective use.
15915963|NCT03527914|Other|Goal Based Outcomes|Up to three goals can be tracked during treatment, although patients often decide to just focus on one. Progress on the goal is then quantitatively rated by the patient, with the provider, at every appointment. Adjustments in the care are then made in an iterative process to ensure that the goal will be met.
15915964|NCT03527914|Other|Treatment as Usual|Patients will receive their standard care at the Outpatient Mental Health Service
15915965|NCT03527901|Diagnostic Test|GCF collection with aMMP-8 chair side test|
15915966|NCT03527901|Other|Saliva collection|
15915967|NCT03527888|Drug|Anlotinib|Anlotinib QD po and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
15915968|NCT03527875|Procedure|PTBD group|Percutaneous Transhepatic Biliary Drainage, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients
15915969|NCT03527875|Procedure|ENBD group|Endoscopic Nasobiliary Drainage, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients
15915970|NCT03527875|Procedure|EBS group|Endoscopic Biliary Stenting, a kind of Preoperative Biliary Drainage methods for hilar cholangiocarcinoma patients
15915971|NCT03527862|Other|Treatment according to lung ultrasonography|Appropriate treatment for atelectasis, pleural effusion, pulmonary edema, pneumothorax or pneumonia which are confirmed by lung ultrasonography
15915972|NCT03527849|Behavioral|Mindfulness-Based Stress Reduction|The intervention will be an MBSR course.
15915973|NCT03527849|Behavioral|Health Enhancement Program|Propose to use an active control training, the Health Enhancement Program (HEP), an intervention designed to isolate mindfulness as a testable active ingredient. HEP and MBSR are structurally equivalent in that they share the same amount of in- and out-of class work time. The content of the HEP intervention meet the following criteria: (1) class activities match MBSR activities as closely as possible, (2) activities represent valid, active, therapeutic ingredients in their own right, and (3) these ingredients do not include mindfulness.
15915974|NCT03527836|Drug|Lidocaine brachial plexus block|Combined Axillary-supraclavicular approach to brachial plexus with lidocaine
15915975|NCT03527836|Drug|Bupivacaine brachial plexus block|Combined Axillary-supraclavicular approach to brachial plexus with bupivacaine
15915976|NCT03527836|Drug|Mixture brachial plexus block|Combined Axillary-supraclavicular approach to brachial plexus with mixture solution of 20 ml bupivacaine 0.5% and 10 ml lidocaine 1%
15915977|NCT03527810|Procedure|Sleeve Gastrectomy Without Interrogation of Hiatus|Weight-loss procedure to reduce the stomach.
15915978|NCT03527810|Procedure|Sleeve Gastrectomy With Interrogation of Hiatus|Weight-loss procedure to reduce the stomach with hiatal repair.
15915979|NCT03527797|Other|Titration of support level|Increasing support in case diaphragm activity is too high. Decreasing support in case diaphragm activity is too low.
15916179|NCT03526289|Other|Saline|5-hour infusion of saline (placebo) (time point 0-300 minutes)
15915982|NCT03527784|Device|Dynamesh IPST|Dynamesh IPST is used on intraperitoneal onlay position to prevent parastomal hernia
15915983|NCT03527771|Device|Video-assisted CPR|Emergency call using a Software capable of video Transmission for Video assistance in CPR
15915984|NCT03527771|Drug|telephone-assisted CPR|Emergency call with telephone assistance in CPR
15915985|NCT03527758|Device|Flo TracIQ with HPI software|Patients will be monitored intraoperatively with Flo TracIQ with HPI software in order to predict hypotensive events. Blood sample will be obtained in order to evaluate ealy organ dysfunction.
15915986|NCT03527745|Drug|Albendazole|Single dose of albendazole (200mg, dependent on treatment cohort)
15915987|NCT03527745|Drug|Albendazole|Single dose of albendazole (400mg, dependent on treatment cohort)
15915988|NCT03527745|Drug|Albendazole|Single dose of albendazole (600mg, dependent on treatment cohort)
15915989|NCT03527745|Drug|Albendazole|Single dose of albendazole (800mg, dependent on treatment cohort)
15915990|NCT03527745|Drug|Placebo|Matching placebo tablets will be obtained from Fagron, Germany.
15915991|NCT03527732|Drug|Albendazole|Monotherapy of albendazole (400 mg)
15915992|NCT03527732|Drug|Albendazole and Ivermectin|Combination therapy of albendazole (400 mg) and ivermectin (200 µg/kg)
15915993|NCT03527719|Other|Strengthen the performance appraisal system|In accordance with the performance evaluation standards for the management of hypertension patients in national basic public health services and on the basis of routine management such as blood pressure monitoring and lifestyle guidance, medication rate, medication compliance, control rate and patient follow-up rate of participants in the intervention group will be included in the performance assessment index system and a complete performance appraisal evaluation and reward and punishment system will be established.
15915994|NCT03527719|Other|Establishing a chronic disease management system|Assigning a professional staff for the propaganda and treatment of chronic disease prevention and management for each study village, who is responsible for supervising participants taking medicine according to doctor's prescription, regularly measuring blood pressure, promoting healthy lifestyles, and regularly organizing hypertensive participants to carry out self-management group activities, enhance the active awareness of hypertension prevention and control. They will cooperate with the village doctors to manage blood pressure control of hypertensive patients.
15915995|NCT03527719|Other|Simulating medical insurance reform|"Through the provision of preferential anti-hypertensive drugs to the participants in the intervention group, the increase of Medicare reimbursement proportion for hypertension is simulated to provide affordable, effective free antihypertensive drugs to the participants with poor economic conditions in the management population. Through the measures above, the participants' compliance with medication will be improved.
~The project will select the best antihypertensive drugs for rural patients, and to implement preferential policies for buying gifts. At the same time, inexpensive and effective free antihypertensive drugs including nitrendipine tablets, captopril tablets and indapamide tablets will be supplied to the impoverished hypertensive patients free of charge."
15915996|NCT03527719|Other|Enhancing village doctors'ability.|Standardizing training programs for village doctors in hypertension prevention, control, management ,diagnosis and treatment capabilities, including clinical norms of hypertension medication, professional knowledge about commonly used antihypertensive drugs'adverse reactions, contraindications and drug adjustment strategies and disposal principles, will improve the rationality of managing drug treatment programs for participants, and comprehensively improve participants' compliance and blood pressure control rate. At the same time, a quarterly evaluation and assessment system for the medical treatment capacity of village doctors for hypertension will be established.
15915997|NCT03527719|Other|Establishing a supervision mechanism for the effect|Establish a hypertension management effect monitoring team composed of the county (district) health commission, the disease prevention and control center, and the township prevention and protection station to remind and urge village doctors to strengthen the management of blood pressure in participants who do not meet the standard and to increase the compliance rate. Periodically form a paper work record and report to the provincial project team's quality control center.
15915998|NCT03527719|Other|Establishing a hierarchical management system for patients|Establish a hierarchical management system for participants at the municipal level and superior hospitals - county hospitals - village doctors. Three levels of doctors in the management system sign contracted management. Each city-level and superior hospital doctor signs up with three county-level hospital doctors, and each county-level hospital doctor signs up with ten village doctors. They will establish a three-level doctors WeChat (Chinese mainstream social software) communication group to ensure the rationality of the program and the participants' safety during the diagnosis and treatment.
15915999|NCT03527719|Behavioral|Enhancing the awareness of blood pressure self-management|Electronic sphygmomanometer will be uniformly distributed among the participants in the intervention group to promote the self-tested blood pressure habits of the participants. The participants will be encouraged to communicate with the village doctors actively to enhance their self-management consciousness of blood pressure.
15916000|NCT03527719|Behavioral|Establishing a self-management group|A self-management group for participants will be established in each of the study village. They will participate in a group activity every quarter to learn about healthy lifestyles, methods on self-tested blood pressure and the risk of hypertension. They will communicate with other patients about the experience in the treatment process and give feedback to village doctors about the treatment process for the enhancement of the confidence for long-term medication.
15916001|NCT03527719|Other|Establishing patient encouragement system|A self-administration point encouragement system for participants' blood pressure will be established to accumulate points according to the participants' self-blood pressure measurement, medication compliance, follow-up compliance, and self-management team participation. Rewards will be based on quarterly and annual points to cultivate and enhance participants' initiative consciousness of self-management of blood pressure.
15916002|NCT03527693|Device|Lipogems injection|Micro-fragmented adipose tissue (10 cc) was injected intra-articular after the arthroscopic procedure (shaving or shaving + meniscectomy).
15916003|NCT03527680|Dietary Supplement|Lactobacillus rhamnosus|daily one capsule containing 1.6*107 CFU of Lactobacillus Rhamnosus prepared by Tabriz Nutrition Research Center from yogurt and cheese of different farms located in the suburbs Heris, after meal for 28 days
15916004|NCT03527680|Drug|Placebo - Cap|daily one capsule of placebo
15916180|NCT03526276|Other|CPP-ACP paste|Children will brush their teeth with CPP-ACP paste twice daily.
15916005|NCT03527667|Behavioral|Financial incentives|Treatment arm participants will receive financial incentives ($20 per week) contingent on biochemically verified smoking abstinence submitted once daily for the time period allocated.
15916006|NCT03527654|Other|Observational|Surveys, blood and urine collected prospectively over 24 months.
15916007|NCT03527641|Behavioral|CookingMatters|Nutrition education and hands-on cooking lessons for the whole family
15916008|NCT03527641|Behavioral|Parent Education|Parenting, physical activity and nutrition education, and family health education for parents
15916009|NCT03527641|Behavioral|Physical Activity|Physical fitness activities for teens
15916010|NCT03527641|Behavioral|Health Education|Health knowledge curriculum for adolescents
15916011|NCT03527641|Behavioral|Mindfulness-based Stress Reduction|Adolescent mindfulness curriculum
15916012|NCT03527641|Behavioral|Brief Mindfulness Intervention|Parent-based education and experiential learning of mindfulness-based tools
15916013|NCT03527628|Drug|Adriamycin|25mg/m2 Bolus injection via fast running drip of 0.9% NaCl in days 1 and 15 of each 28 day cycle.
15916014|NCT03527628|Drug|Cyclophosphamide|400mg/m2 Infusion in 500ml sodium chloride 0.9%over 30min. in days 1 and 15 of each 28 day cycle
15916015|NCT03527628|Drug|Vinblastine|6mg/m2 Intravenous infusion in 50ml sodium chloride 0.9% over 10 minutes, in days 1 and 15 of each 28 day cycle
15916016|NCT03527628|Drug|Dacarbazine|375mg/m2 Infusion in 500mls 0.9% NaCI over least 60mins. in days 1 and 15 of each 28 day cycle
15916017|NCT03527628|Drug|Brentuximab Vedotin|1.2mg/kg Intravenous infusion, in days 1 and 15 of each 28 day cycle
15916018|NCT03527628|Drug|ABVD|All enrolled patients receive 2 cycles of ABVD (Adriamycin 25mg/m2, Bleomycin10,000units/m2, Vinblastine 6mg/m2 and Dacarbazine 375mg/m2)
15916019|NCT03527615|Other|Clinical Pharmacist Medication Review|Programmatic review of physician orders for direct anticoagulants by clinical pharmacists.
15916020|NCT03527602|Procedure|Foraminal enlargement|After determining the working length, a rotary file will be inserted 1 mm beyond the WL and the apical foramen will be enlarged.
15916021|NCT03527589|Device|Prostate artery embolization|Patients with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) will be treated with Embosphere Microspheres via prostate artery embolization.
15916022|NCT03527576|Drug|Dexamethasone|Intravenous injection of 0.15 mg/kg of dexamethasone before the surgery.
15916023|NCT03527576|Drug|NaCl 0.0308 MEQ/ML Injectable Solution|Intravenous injection of NaCl 0.9% before the surgery.
15916024|NCT03527563|Behavioral|Internet Medical Model|Subjects in the Internet group should upload blood pressure monitoring data at least once per day. It is highly recommended to upload two pressure monitoring results to capture more blood pressure information. The warning value of blood pressure set in the cloud database is systolic blood pressure ≥ 180mmHg or ≤ 100mmHg and diastolic blood pressure ≥ 110mmHg or ≤ 60mmHg. After enrollment, subjects and physicians communicate via telephone or Internet every two weeks until blood pressure is well controlled judged by physician. Then the frequency of communication will be changed to once a month. Once there are lacks of blood pressure data in 3 days of each week, or. blood pressure values of the subject exceed the warning value in 2 days of consecutive 3 days, the physician will take the initiative to contact the patient for disease inquiry.
15916025|NCT03527550|Other|Cognitive Control Training|Cognitive Control Training involves daily practice with one of two computerized interventions. The first intervention is an adaptive Go/No-Go task to provide practice in the domain of response inhibition. Participants press a key as fast as possible in response to stimuli (letters of the alphabet), but must inhibit responses to a specific letter. The second intervention is an adaptive Paced Auditory Serial Addition Task (PASAT), designed to practice working memory. Participants are presented with single numbers presented aurally, and must add each number they hear to the previous number and click the correct sum on the screen.
15916026|NCT03527537|Drug|Insulin|Insulin may be administered base on glucose log values. The dosing of the insulin will be determined by the provider using typical management of gestational diabetes.
15916027|NCT03527524|Other|exercise with ball|exercise with ball
15916028|NCT03527524|Other|exercise without ball|exercise without ball
15916029|NCT03527511|Other|Measure of etecalcetide on osteoclastic biology|In vitro evaluation of osteoclastic biology after blood sampling of patients.
15916030|NCT03527498|Device|Baby treadmill|The newborns who received treadmill intervention were stimulated by running 3 times a week for a total of 10 minutes each time (complete in 5 cycles, 2 minutes per cycle, 2 minutes after the completion of one cycle and rest for 2 minutes to start the next cycle). Until the completion and completion of the five cycles). During the remaining four days of each week, other physical rehabilitation training is carried out by the rehabilitator in accordance with the established rehabilitation plan. The stimulation of running lasted from 3 months of corrected gestational age to being able to walk alone for 3 steps or to correct for 18 months.
15916031|NCT03527498|Behavioral|Physical rehabilitation training|Suitable for general physical rehabilitation training of all infants with cerebral palsy.
15916032|NCT03527485|Diagnostic Test|11UCB-J PET Scan|11UCB-J PET Scan
15916033|NCT03527472|Drug|Memantine|Memantine is an FDA-approved drug for the treatment of Alzheimer's disease.
15916034|NCT03527472|Drug|Placebo|The placebo will match the study drug in appearance, dose, and frequency. It will not contain any active drug (memantine).
15916035|NCT03527459|Behavioral|SPARC B|SPARC B includes all aspects of the SPARC A clinical program, as well as targeting negative cognitions of perceived burdensomeness.
15916036|NCT03527459|Behavioral|SPARC A|SPARC A is an existing clinical program with a general focus on negative cognitions.
15916037|NCT03527446|Behavioral|Sprint Interval Training|The 4-week sprint interval intervention will consist of a work-rest ratio of four 30-s intervals of exercise at maximal capacity and 4-min of passive recovery at 50% of maximal capacity between intervals. There will be three sessions per week.
15916038|NCT03527433|Procedure|New closure technique|In the intervention arm, an average of two sutures will be placed at each cm length of the wound, thus the number of sutures placed should be equal to at least double the length of the wound in cm.The aim is to have a ratio of 4:1 between the overall lengths of the suture to the length of the wound being closed
15916039|NCT03527420|Other|Exercise training|Twelve weeks of aerobic exercise training
15916076|NCT03527147|Drug|Rituximab|Rituximab infusions will be administered weekly for one cycle (28 days) and then every 4 weeks up to 6 cycles.
15916040|NCT03527381|Drug|Nitric Oxide|40 ppm of exogenous gaseous nitric oxide is supplied directly to the oxygenator in the cardiopulmonary bypass circuit during cardiac surgery.
15916041|NCT03527381|Other|Standard CPB|Standard CPB protocol of delivery of air gas mixture to the cardiopulmonary bypass circuit during cardiac surgery.
15916042|NCT03527368|Behavioral|Time-restricted feeding|Participants consume food earlier in the day
15916043|NCT03527368|Behavioral|Usual feeding pattern|Participants consume food later in the day
15916044|NCT03527355|Biological|Vi-DT|Manufacturer: SK Bioscience Co., Ltd. Ingredient: Purified Vi-polysaccharide conjugated to diphtheria toxoid Dose: 0.5 mL/Vial
15916045|NCT03527355|Biological|FluQuadri™|"Manufacturer: Sanofi Pasteur Dose: 0.25 ml
~*Participants who have not been vaccinated for flu before, will receive a second dose of flu-vaccine after unblinding."
15916046|NCT03527355|Other|0.9% sodium chloride isotonic solution|Manufacture: Euro-Med Inc. Dose: 0.5 mL
15916047|NCT03527329|Device|WarmTouch Model 5900, Covidien Ltd, Mansfield, USA|Forced-air warming will be applied following routine clinical practice. The pre-warming time will depend on the time the patient has to wait before entering in the operating room. Prewarming time will be recorded for each patient.
15916048|NCT03527316|Drug|MDMA|125 mg MDMA per os, single dose
15916049|NCT03527316|Drug|Placebo|Capsules containing mannitol looking identical to the other drugs.
15916050|NCT03527303|Behavioral|Meditation|10 minute per day, 8 week digital meditation
15916051|NCT03527290|Behavioral|Time Restricted Eating|The intervention is delivered in a paradigm in which an individual with abdominal obesity would be referred by their physician to receive dietary counseling from a Registered Dietitian (RD). The aim of the intervention is to improve cardiometabolic health and assist with weight management via 4, individualized counseling sessions over the course of 8 weeks. Participants are educated on basic concepts related to circadian rhythms, metabolism and TRE; and the evidence demonstrating benefit of TRE in animal models and humans. The goal is provide rationale for the potential benefits of a TRE approach. In addition, the RD sessions focus on developing a plan for successfully implementing a TRE approach, identifying challenges for adherence, and a plan for dealing with real or potential challenges. The counseling is focused the TRE concept, with no specific direction or counseling related to modifying the content of the participant's diet or any prescription to reduce energy intake.
15916052|NCT03527290|Behavioral|Standard Cardiometabolic Health Diet|The intervention is delivered in a paradigm in which an individual with abdominal obesity would be referred by their physician to receive dietary counseling from a Registered Dietitian (RD). The aim of the intervention is to improve cardiometabolic health and assist with weight management via 4, individualized counseling sessions over the course of 8 weeks. Participants are educated on basic concepts and known benefits related to eating a diet for cardiometabolic health and weight management recommended by the American Heart Association and the Academy of Nutrition and Dietetics as a standard of practice for dietitians in healthcare settings. The RD sessions focus on adopting a dietary pattern aligned with this approach, identifying challenges to adopting this dietary pattern, and education and plans for dealing with real or potential challenges. The counseling gives no direction related to modifying the timing of dietary intake or any prescription to reduce energy intake.
15916053|NCT03527277|Other|Naturally-sweetened orange juice|Commercially-available ready-to-serve refrigerated orange juice
15916054|NCT03527277|Other|Sugar-sweetened beverage|Sugar-sweetened water flavored with Kool-Aid (TM)
15916055|NCT03527264|Drug|Nivolumab induction|2 doses Nivolumab 240mg IV
15916056|NCT03527264|Drug|Cisplatin|40 mg/m2 of cisplatin: Dosing on Days: 1, 8, 15, 22, 29, 36 beginning on day 1 of radiation therapy.
15916057|NCT03527264|Radiation|Radiation|"Total dose of 45 Gy in 25 fractions at 180 cGy/fx
~Whole pelvic or extended field"
15916058|NCT03527264|Drug|Nivolumab with chemoradiation|Nivolumab 240mg IV every 14 days (+/- 3 days) for 3 doses, administered concomitantly during chemoradiation and beginning day 1 of Radiation.
15916059|NCT03527264|Drug|Nivolumab maintenance|Nivolumab 480 mg IV every 4 weeks for 2 years
15916060|NCT03527251|Drug|Ipilimumab|Patients received two doses of intravenous ipilimumab (at a dose of 1 mg per kilogram of body weight) every 3 weeks, following by intravenous SHR-1210 (at a fixed dose of 200mg) every 2 weeks.
15916061|NCT03527251|Drug|SHR-1210|Patients received two doses of intravenous ipilimumab (at a dose of 1 mg per kilogram of body weight) every 3 weeks, following by intravenous SHR-1210 (at a fixed dose of 200mg) every 2 weeks.
15916062|NCT03527238|Other|PPM-based Computation Assisted Drug Dosing|Tacrolimus dosing based on application of PPM.
15916063|NCT03527238|Drug|Tacrolimus|Dosing of calcineurin inhibitor, tacrolimus
15916064|NCT03527225|Other|Music|The patient's preferred music will be played during the first radiotherapy treatment session from speakers located inside the treatment room. The duration of the music will be 10 to 20 minutes. The music will be turned off at the patient's request if it bothers them. Length of music playing and if the patient requested that it be turned off, will be recorded.
15916065|NCT03527212|Drug|SJP-0035 0.001%|Self-administration of 1 drop (approximately 40 µL) of 0.001% SJP-0035 ophthalmic solution into each eye 4 times daily for 4 weeks
15916066|NCT03527212|Drug|Placebo|Self-administration of 1 drop (approximately 40 µL) of placebo ophthalmic solution into each eye 4 times daily for 4 weeks
15916067|NCT03527199|Diagnostic Test|Pelvic CT or MRI + MDP bone scan + or - 18F-NaF PET/CT(SOC)|Standard of care-Pelvic CT or MRI and MDP bone scan + or - 18F-NaF PET/CT
15916068|NCT03527186|Drug|Risperidone ISM® 100 mg|100 mg of risperidone ISM® administered every 4 weeks
15916069|NCT03527173|Biological|S.sonnei vaccine|Subjects receiving 2 doses of the study vaccine by intramuscular route, 28 days apart (at Day 1 and Day 29).
15916070|NCT03527173|Drug|Placebo|Subjects receiving 2 doses of placebo by intramuscular route, 28 days apart (at Day 1 and Day 29).
15916071|NCT03527173|Biological|S. sonnei 53G challenge strain|Subjects receiving the challenge dose of S. sonnei 53G strain, orally, at Day 57.
15916072|NCT03527147|Drug|AZD9150|AZD9150 will be administered as a 1-hour intravenous (IV) infusion on Days 1, 3, 5 of Cycle 1, followed by weekly infusions (starting Day 8 of Cycle 1 and beyond).
15916073|NCT03527147|Drug|Acalabrutinib|Acalabrutinib will be administered orally twice daily (bid).
15916074|NCT03527147|Drug|AZD6738|AZD6738 will be administered orally twice daily (bid).
15916075|NCT03527147|Drug|Hu5F9-G4|Hu5F9-G4 infusions will be administered weekly.
15916078|NCT03527134|Drug|Amantadine|patients will receive amantadine 100 mg by month 2 h before the induction of general anesthesia and then 100 mg each time, three times per day for 5 days.
15916079|NCT03527121|Other|ESP physiotherapy|A single session with advice and instructions from an ESP physiotherapist in rest, ice, compression and elevation AND pain guided early weight bearing plus a written home-based exercise program.
15916080|NCT03527121|Other|Usual care|A single session with advice and instructions from a physician in rest, ice, compression and elevation (usual care group).
15916081|NCT03527108|Drug|Nivolumab|The treatment will be given on a 28-day cycle, with doses of nivolumab and ramucirumab given on days 1 and 15. The dose of nivolumab will be fixed at 240 mg. Nivolumab should be administered first, followed by premedication, and then ramucirumab. Ramucirumab should be administered approximately 30 minutes after premedication
15916082|NCT03527108|Drug|Ramucirumab|The treatment will be given on a 28-day cycle, with doses of nivolumab and ramucirumab given on days 1 and 15. The dose of ramucirumab will depend upon the patient weight as noted below. Nivolumab should be administered first, followed by premedication, and then ramucirumab. Ramucirumab should be administered approximately 30 minutes after premedication
15916083|NCT03527095|Drug|FDL169|CFTR corrector
15916084|NCT03527082|Other|Questionnaire|"Questionnaire of 20 items evaluating attitudes and perception of mesh use in gynaecological surgery. Questionnaire will take 10 minutes to complete. For non-English speaking patients a translator will be sought, where feasible to help women complete the questionnaire.
~Participation will be entirely voluntary and also the questionnaire will be piloted to ensure that questions asked are clear and concise. Questionnaire is anonymised and does not contain patient identifying information thereby eliminating breach of confidentiality."
15916085|NCT03527069|Drug|Cipros 10 association|oral, once a day.
15916086|NCT03527069|Drug|Crestor 10 mg|oral, once a day.
15916087|NCT03527056|Biological|Fecal Microbiota Transplantation|This is a parallel arm study. All participants in the experimental arm will receive a single fecal transplantation via oral capsules to determine effectiveness and safety in decolonizing gastrointestinal CRE.
15916088|NCT03527043|Drug|Escitalopram|10mg by mouth daily for 6 weeks
15916089|NCT03527043|Other|Placebo|matched placebo control by mouth for 6 weeks
15916090|NCT03527030|Other|Survey on Use of Tobacco Products in the General Population|Face-to-face survey to estimate the prevalence of current tobacco use status in the general population of the Greater London area.
15916091|NCT03527030|Other|Survey on Use of Tobacco Products in IQOS Users|Online survey to describe patterns of use in users of IQOS residing in the Greater London area.
15916092|NCT03527017|Other|Survey on Use of Tobacco Products in the General Population|Face-to-face survey to estimate the prevalence of current tobacco use status in the general population of Germany.
15916093|NCT03527017|Other|Survey on Use of Tobacco Products in IQOS Users|Online survey to describe patterns of use in adult IQOS users residing in Germany.
15916094|NCT03527004|Other|Survey on Use of Tobacco Products in the General Population|Face-to-face survey to estimate the prevalence of current tobacco use status in the general population of Italy.
15916095|NCT03527004|Other|Survey on Use of Tobacco Products in IQOS Users|Online survey to describe patterns of use in IQOS users residing in Italy.
15916096|NCT03526991|Device|Spinal Cord Stimulator (SCS)|"The SCS implantation technique consists of inserting epidural leads-containing multiple stimulating electrodes (8). Two leads will be implanted percutaneously into the epidural space.
~The implantable pulse generator (IPG) is a neurostimulation system designed to deliver low-intensity electrical impulses. The system is intended to be used with leads and extensions that are compatible with the system. This neurostimulation system is indicated (FDA approved) as an aid in the management of chronic, intractable pain of the trunk and/or limbs. The intended use in this study is considered experimental."
15916097|NCT03526978|Biological|Investigational sIPV|Three intramuscular injections of the investigational vaccine (0.5 ml) on Day 0, Day 30 and Day 60 respectively; Single intramuscular injection of the investigational vaccine (0.5 ml) at 18 months; Intervention: investigational sIPV
15916098|NCT03526978|Biological|Control IPV|Three intramuscular injections of the control vaccine (0.5 ml) on Day 0, Day 30 and Day 60 respectively; Single intramuscular injection of the control vaccine (0.5 ml) at 18 months; Intervention:control IPV
15916099|NCT03526965|Other|Yoga Chikitsa|Intervention consisted of combination of static movements, yoga style exercise, yoga postures, breathing practices, relaxation and yoga counselling.
15916100|NCT03526965|Drug|Usual care|Intervention included pain medications and exercise movements for neck.
15916101|NCT03526952|Other|Internet-Delivered Intervention for Sexual Re-Adjustment|Couples will meet with a therapist via video-conferencing for two 1.5-hr sessions. The therapist will facilitate couples' communication about their sexual and intimate relationship while providing psychoeducation about couple coping and sexuality after cancer and with an ostomy. Discussion will focus on current concerns, motivations for sex, relational strengths, and intimacy and sensual pleasure. Couples will also be encouraged to practice a sensate focusing exercise between sessions.
15916102|NCT03526952|Other|Written Educational Material|Couples will receive written educational material for patients coping with changes in intimacy and sexuality when living with a permanent ostomy. This educational material is published by the United Ostomy Associations of America, Inc. and is available for free download from their website. Couples will have two weeks to read this material.
15916103|NCT03526926|Drug|CPX-351|VYXEOS is administered as an intravenous (IV) infusion over approximately 90 minutes.
15916104|NCT03526913|Procedure|PRP|PRP: autologous platelet-rich plasma
15916105|NCT03526913|Procedure|STSG|skin graft: Split Thickness Skin Grafting (STSG)
15916106|NCT03526900|Drug|Atezolizumab|"Induction (four or six 21-day cycles) : Atezolizumab 1200 mg / iv + carboplatin 5 AUCs + pemetrexed 500 mg/m2
~Maintenance (21-day cycles): atezolizumab 1200 mg/iv + pemetrexed 500 mg/m2."
15916107|NCT03526887|Drug|Pembrolizumab|200 mg, Q3W
15916108|NCT03526887|Drug|Pembrolizumab|200 mg, Q3W
15916109|NCT03526874|Drug|Lidocaine 4% Topical Application Cream [LMX 4]|Run-in Step: All subjects receive 32 mg (4 cm ribbon of cream) applied, bilaterally, over greater occipital nerve.
15916110|NCT03526874|Drug|Lidocaine Hydrochloride 2 mg/mL Injectable Solution|Subjects, who continue to experience headache pain after the run-in step, receive 2 (2 mL) injections of the active treatment.
15916521|NCT03523689|Procedure|Radial Probe Endobronchial Ultrasound|Undergo RP-EBUS
15916111|NCT03526874|Drug|Normal Saline|Subjects, who continue to experience headache pain after the run-in step, receive 2 (2 mL) injections of the comparator.
15916114|NCT03526848|Drug|3BNC117|Intravenous infusion of 3BNC117
15916115|NCT03526848|Drug|10-1074|Intravenous infusion of 3BNC117
15916116|NCT03526848|Other|Analytical treatment interruption|Analytical treatment interruption
15916117|NCT03526835|Drug|MCLA-158|full-length IgG1 bispecific antibody targeting EGFR and LGR5
15916118|NCT03526822|Biological|Blood sample|Five blood sample in pre-, post-operative period, before radiotherapy, before adjuvant temozolomide and at relapse in newly diagnosed glioblastoma
15916119|NCT03526822|Biological|Tumor sample|One tumor sample in operative period
15916120|NCT03526809|Diagnostic Test|MRI scan and FDG-PET scan|Scanning with MRI and FDG-PET
15916121|NCT03526796|Procedure|Hyperbaric oxygen therapy|Patients were maintained at 2.4 ATA with 100% oxygen for 90 min and then decompressed back to 1 ATA. The treatment duration is 4 weeks and extends to 6 weeks if necessary.
15916122|NCT03526783|Procedure|Roux en Y gastric bypass|Laparoscopic Roux en Y gastric bypass (150 cm alimentary limb, 50 cm biliopancreaty limb)
15916123|NCT03526783|Procedure|Mini/One anastomosis gastric bypass|Laparoscopic Mini/One anastomosis gastric bypass (200 cm biliopancreatic limb)
15916124|NCT03526770|Other|Group 1: no intervention|Unstimulated saliva samples are collected from the subject to measure the pH of saliva after 5, 15, 30, 45 and 60 minutes of consumption of the test carbonated drink without any intervention
15916125|NCT03526770|Other|Group 2: tap water gargle|The subject will use 10 ml of tap water as mouth rinse to swish for 60 seconds and spit. Unstimulated saliva samples are collected from the subject to measure and record the pH of saliva at 15, 30 and 45 minutes after the subject completes the gargle as an intervention.
15916126|NCT03526770|Drug|Group 3: 0.2% Chlorhexidine|The subject will use 10 ml of 0.2% Chlorhexidine mouth rinse (Rexidine®, Indoco Remidies Ltd, Mumbai, India) to swish for 60 seconds and spit. Unstimulated saliva samples are collected from the subject to measure and record the pH of saliva at 15, 30 and 45 minutes after the subject completes the gargle as an intervention
15916127|NCT03526770|Other|Group 4: Fluoridated tooth paste|"The subject will Brush with fluoridated toothpaste-(Colgate Total®, Colgate-Palmolive Company, Mumbai, India) for 2 minutes using soft brush.
~Unstimulated saliva samples are collected from the subject to measure and record the pH of saliva at 15, 30 and 45 minutes after the subject completes using tooth paste as an intervention."
15916128|NCT03526770|Other|Group 5: Polyol containing gum|"The subject will chew polyol containing gum (Orbit®, WrigleyCompany) for 5 minutes and spit.
~Unstimulated saliva samples are collected from the subject to measure and record the pH of saliva at 15, 30 and 45 minutes after the subject completes chewing gum as an intervention."
15916129|NCT03526770|Other|Group 6: 1% sodium bicarbonate solution|"The subject will use 10 ml freshly prepared 1% sodium bicarbonate w/v solution to swish for 60 seconds and spit.
~Unstimulated saliva samples are collected from the subject to measure and record the pH of saliva at 15, 30 and 45 minutes after the subject completes the gargle as an intervention."
15916130|NCT03526757|Other|Standing Pilates protocol|Subjects will be submitted to a bi-weekly, 50-minute session of Pilates exercises focusing on orthostatic position, for twelve weeks. The following equipment will be used: The Cadillac, Reformer and Chair, emphasizing balance training in the orthostatic position.
15916131|NCT03526757|Other|Standard Pilates protocol|Subjects will be submitted to a bi-weekly, 50-minute session of the standard sequence of Pilates exercises (traditional sequence of the contemporary / classical method) for twelve weeks. The exercises will be performed using the same equipment used in the intervention group, but following the dorsal decubitus, sedestation and orthostasis, in a time-balanced distribution in each session.
15916132|NCT03526744|Dietary Supplement|marine protein hydrolysate 1234|"Dietary Supplement for e.g. in this order: MPH 1600 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 800 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 2400 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 3200 mg for 7 days, than 7 days wash-out."
15916133|NCT03526744|Dietary Supplement|marine protein hydrolysate 2134|"Dietary Supplement for e.g. in this order: MPH 3200 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 800 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 2400 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 1600 mg for 7 days, than 7 days wash-out."
15916134|NCT03526744|Dietary Supplement|marine protein hydrolysate 3124|"Dietary Supplement for e.g. in this order: MPH 2400 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 3200 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 1600 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 800 mg for 7 days, than 7 days wash-out."
15916135|NCT03526744|Dietary Supplement|marine protein hydrolysate 4123|"Dietary Supplement for e.g. in this order: MPH 1600 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 800 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 3200 mg for 7 days, than 7 days wash-out. Dietary Supplement: MPH 2400 mg for 7 days, than 7 days wash-out."
15916136|NCT03526731|Other|ultrasound guided quadratus lumborum block|ultrasound guided quadratus lumborum block for post operative pain control after unilateral inguinal hernia repair.
15916137|NCT03526705|Device|NB-UVB|Phototherapy
15916138|NCT03526692|Behavioral|Neurofeedback|Neurofeedback experiment will consist of 30 sessions of neurofeedback training, twice or three times a week during maximum 4 months. The two experimental groups will undergo questionnaires, EEG recording and neuropsychological assessments in three-time points, pre-training (T0), post-training (T1) and 3 months follow-up (T2). Electroencephalography will be recorded by a technician in EEGFor each participant, EEG power spectrum will be calculated in pre (T0) and post neurofeedback training/psycho-pedagogical care at T2 and T3.
15916139|NCT03526679|Drug|Eribulin|lenvatinib 14mg po daily; eribulin 1.1mg/m2 D1, D8, every 21 days
15916140|NCT03526679|Drug|Lenvatinib|lenvatinib 14mg po daily; eribulin 1.1mg/m2 D1, D8, every 21 days
15916141|NCT03526666|Other|Peripheral blood collection|Peripheral blood collection for the measurement of ascorbic acid levels and banking of plasma and buffy coat for future resrearch.
15916522|NCT03523676|Diagnostic Test|Red Cell Distribution Width|
15916142|NCT03526653|Other|exercise without visual stimuli|exercise on an ergometer or motomed in an environment without other visual stimuli
15916143|NCT03526653|Other|excercise with National Geografics|exercise on an ergometer or motomed while watching the National Geografics channel on television
15916144|NCT03526653|Other|Exercise with MemoRide|excercise on an ergometer or motomed with the interactive software program MemoRide with which participants can exercise in real life on a virtual manner
15916145|NCT03526640|Device|The BioSentry Tract Sealant System|The BioSentry Tract Sealant System consists of a delivery system and a coaxial adapter with Bio-Seal™ plug. The hydrogel plug is deployed in the tract created by the lung biopsy needle and self-expands upon contact with moist tissue.
15916146|NCT03526601|Diagnostic Test|NT-proBNP, echocardiography|screening
15916147|NCT03526588|Biological|Autologous umbilical cord blood|6×10^6 mononuclear cells isolated from the patient's own umbilical cord blood per dose. 4 total doses administered intravenously over 7 days.
15916148|NCT03526575|Drug|Zolpidem|
15916149|NCT03526562|Behavioral|Exercise|Exercise according to dose escalation
15916150|NCT03526549|Biological|EN3835|Collagenase Clostridium Histolyticum (CCH)
15916151|NCT03526536|Drug|IV Novolin R human insulin|Novolin R human insulin, Novo Nordisk Inc. Plainsboro, NJ
15916152|NCT03526523|Behavioral|Mindfulness-based stress reduction|8 weekly 2.5-hour group sessions of mindfulness based stress reduction, led by a certified MBSR instructor
15916153|NCT03526510|Radiation|Conventionally Fractionated versus Hypofractionated Boost|
15916154|NCT03526484|Behavioral|Standard of Care|The provider will review the urinalysis results prior to conducting the in-office procedure and will make clinical decisions taking into account those results.
15916155|NCT03526484|Behavioral|Experimental|The provider will not review the urinalysis results prior to conducting the in-office procedure, and therefore will not make clinical decisions taking those results into account.
15916156|NCT03526471|Device|Omega™ Left Atrial Appendage (LAA) Occluder|catheter delivery of Omega device in the left atrial appendage
15916157|NCT03526458|Device|Holmium:YAG laser|Treatment of urolithiasis is commonly done using the holmium:YAG laser as this has been shown to be a safe and effective method of treating a wide variety of stones and is currently considered the standard of care (AUA Guideline Panel on the Surgical Management of Stones)
15916158|NCT03526445|Drug|Glucagon|Glucagon (4 ng/kg/min)
15916159|NCT03526445|Drug|Saline|Placebo
15916160|NCT03526432|Drug|Bevacizumab|Bevacizumab will be administered by IV infusion at 15mg/kg on Day 1 of every 21-days cycle.
15916161|NCT03526432|Drug|Atezolizumab|Atezolizumab will be administered by IV infusion at a fixed dose of 1200 mg on Day 1 of each 21-day cycle until disease progression, unacceptable toxicity, loss of clinical benefit as determined by the investigator.
15916162|NCT03526419|Drug|Bupivacaine liposome|blood and milk samples will be obtained from those subjects after TAP block
15916163|NCT03526406|Dietary Supplement|CP9700|400 mg CP9700 along with modified cellulose (MCC), magnesioum strearate, slica (sillicon dioxide), Gelatin, FD&C Red No. 40, titanium dioxide, sodium lauryl sulfate, glycerin, brilliant blue FCF consumed with breakfast in a 1 capsule per day regimen.
15916164|NCT03526406|Dietary Supplement|Matched Placebo|Maltodextrin along with modified cellulose (MCC), magnesioum strearate, slica (sillicon dioxide), Gelatin, FD&C Red No. 40, titanium dioxide, sodium lauryl sulfate, glycerin, brilliant blue FCF consumed with breakfast in a 1 capsule per day regimen.
15916165|NCT03526393|Device|Survey training equipment|The survey was checking the equipment designed to assist the lifter training survey with greater precision, in aspects of average height of contact of the ball by striker and maximum perimeter of contact with the ball, for the execution of the attack.
15916166|NCT03526393|Device|Attack and serve training equipment|The attack and serve training equipment was designed to assist the athlete in their body positioning for the execution of the fundamentals of the attack and serve, and the correct extension execution of the of trunk, upper limbs and reaction time of contact with the ball.
15916167|NCT03526393|Device|Pass training equipment|The equipment for the training of the pass, it was designed to represent the serve forced and technical, variables height, circumference and average speed of the ball. This equipment has been adapted from the conventional volleyball serve equipment, respecting the limits of the sitting volleyball court.
15916168|NCT03526380|Behavioral|Behavioral: the OPT-IN Intervention|A private one-on-one brief motivational interviewing intervention administered by non-research staff at community organizations. This will take up to 30 minutes to complete. The goal of the intervention is to improve opioid safety and reduce related overdoses among those who has a history of misusing opioids (prescription and illicit). The session will use techniques to change behavior in a respectful, non-confrontational, and non-judgmental manner. This intervention will also seek to empower participants by providing content on bystander response as well as peer outreach, which emphasizes ways to discuss overdose risk with others at risk for overdose.
15916169|NCT03526367|Drug|hydration plus rosuvastatin therapy|In experimental group,a loading dose of rosuvastatin 20mg then 10 mg daily followed for at least 7 days and hydration（3ml/kg/h）last 12 hours after randomized
15916170|NCT03526367|Drug|Standard therapy|Prohibition of use any statins from randomized to 12 hours after procedure; The hydration or not is determined by physicians but 1 ml/kg/h at most.
15916171|NCT03526354|Drug|Brexpiprazole|Brexpiprazole 4mg daily for 12 weeks
15916172|NCT03526354|Other|Treatment as Usual|Current antipsychotic medication for 12 weeks
15916173|NCT03526341|Device|ReliaTack™ Articulating Reloadable Fixation Device|ReliaTack™ Articulating Reloadable Fixation Device with Deep Purchase Tacks
15916174|NCT03526328|Other|EMR and RFA effect on stem cell marker expression in BE/EAC|Observation of EMR and RFA on the expression of putative stem cell biomarkers and correlate them with serum/plasma protein expression and disease progression and/or recurrence (Barrett's esophagus/ esophageal adenocarcinoma)
15916175|NCT03526315|Other|CPP-ACP paste|Children will brush their teeth with CPP-ACP paste twice daily.
15916176|NCT03526315|Other|Fluoride toothpaste|Children will brush their teeth with fluoridated toothpaste twice daily.
15916177|NCT03526315|Other|Both (Fluoride and CPP-ACP)|Children will brush their teeth with fluoridated toothpaste and apply CPP-ACP immediately after tooth brushing, twice daily.
15916178|NCT03526289|Biological|GIP1-42 infusion|5-hour GIP1-42 infusion (time point 0-300 minutes)
15916181|NCT03526276|Other|Fluoride toothpaste|Children will brush their teeth with fluoridated toothpaste twice daily
15916182|NCT03526276|Other|Both (Fluoride and CPP-ACP)|Children will brush their teeth with fluoridated toothpaste and apply CPP-ACP immediately after toothbrushing, twice daily.
15916183|NCT03526263|Procedure|Gastric mucosal devitalization|During routine laparoscopic sleeve gastrectomy surgery, once the greater curvature of the stomach is excised as per normal surgical technique, the investigators will take the specimen out and perform an ablation ex-vivo, with the intention of performing selective mucosal devitalization. This specimen will then be transported to pathology lab for analysis.
15916187|NCT03526237|Behavioral|24 week community based DPP Group Lifestyle Balance Program|a) 12 weekly peer group (adapted Group Lifestyle Balance Program) sessions followed by 3 monthly group maintenance sessions held in Public Housing locations; b) Individual coaching and patient activation during 24 week period; 2) Community Outreach Care Coordination: Referral, navigation assistance, patient activation, and cross-linkage to FQHC services.
15916188|NCT03526237|Behavioral|Wait-List Control community based DPP Group Lifestyle Balance Program|Control arm participants will receive: 1) Usual care in FQHC/primary care clinic 2) Individual counseling about pre-diabetes risk at baseline; mailed written NIDDK patient education materials (weight loss, physical activity, nutrition) at weeks 6, 12, 18; 2) At the end of the 24 week intervention, the wait list control arm will be invited to participate and receive the group based DPP sessions.
15916189|NCT03526224|Drug|Dimethyl Fumarate|Individuals with MS treated with dimethyl fumarate (Tecfidera)
15916190|NCT03526224|Drug|Teriflunomide|Individuals with MS treated with teriflunomide (Aubagio)
15916191|NCT03526211|Device|FES cycling|On the patient, three pairs of electrodes will be applied on tibial hamstring, quadriceps and gluteal muscles of each lower limb. Cycloergometer will be installed in passive mode. Then, optimal stimulation intensity for each muscle will be defined. During twenty minutes, neuromuscular electrical stimulation will generate a passive pedaling on cycloergometer.
15916192|NCT03526198|Device|Force plate|Device: force plate An equipment model with the approach of providing the evaluated person with the movement that is closest to the biomechanical and functional reality of the ankle and foot joint and which could equalize the possible changes of the center of mass would contribute to the clinical evaluation and would provide a more efficient therapeutic reasoning rehabilitation.
15916193|NCT03526185|Drug|Tumor Infiltrating Lymphocytes|The regimen consists of treatment with cyclophosphamide and fludarabine,followed by infusion of up to 3x1011 lymphocytes (minimum of 1x109) expanded in vitro from subjects own resected tumor followed by the administration of aldesleukin (IL-2).
15916194|NCT03526185|Drug|Nivolumab and Ipilimumab|• Within 1 week post discharge subjects will be treated with Nivolumab 1 mg/kg and Ipilimumab 3 mg/kg every 3 weeks for 4 doses. Following this, patients will receive Nivolumab 480 mg every 4 weeks. Adjuvant Nivolumab will continue until evidence of disease progression or inability to tolerate treatment.
15916195|NCT03526172|Procedure|High tibial osteotomy|Uni-lateral medial opening-wedge high tibial osteotomy following a minimally invasive approach.
15916196|NCT03526172|Device|Allograft wedge|Insertion of allograft wedge into the osteotomy gap during the HTO procedure
15916197|NCT03526172|Device|Accelerometer|ActivPal accelerometer attached to thigh of patient to collect objective physical activity data at pre-determined intervals before and after surgery
15916198|NCT03526172|Other|Questionnaire|Validated clinical questionnaires administered to patients to collect subjective physical activity data at pre-determined intervals before and after surgery
15916199|NCT03526159|Drug|Gentamicin Sulfate|Gentamicin (formulated as gentamicin sulfate) is a well-known, well-characterized antibiotic that has been used for four decades as a treatment against gram negative bacteria. It, like other aminoglycoside antibiotics, has the well documented added potential to facilitate readthrough of premature termination codons in eukaryotic cells and organisms.
15916200|NCT03526146|Behavioral|Behavioral: Preventing Loss of Independence through Exercise (PLIE)|PLIE is an integrative exercise program that focuses on training procedural memory for the ability to perform the movements that are most needed for daily function (e.g., transitioning safely from sitting to standing) while increasing mindful body awareness and encouraging social connection. It combines elements from a wide range of Eastern and Western exercise modalities, including occupational therapy, physical therapy, yoga, tai chi, Feldenkrais, Rosen Method, dance movement therapy and mindfulness meditation.
15916201|NCT03526133|Diagnostic Test|Polysomnography (PSG) and wireless sensor Oxistar|Monitoring the apnea-hypopnea index (AHI) derived from PSG and the oxygen desaturation index (ODI) obtained by the Oxistar.
15916202|NCT03526120|Other|Pistachio|Dailly 44 g unsalted pistachios snack for 12 weeks
15916203|NCT03526107|Other|CF Control|CF Control: 583 mg of cocoa flavanols, <1 mg caffeine and <1 mg theobromine
15916204|NCT03526107|Other|CF-Theobromine|CF-Theobromine: 566 mg of cocoa flavanols, 11 mg caffeine and 93 mg theobromine
15916205|NCT03526107|Other|CF-Caffeine|CF-Caffeine: 583 mg of cocoa flavanols, 112 mg caffeine and <1 mg theobromine
15916206|NCT03526094|Other|Flavanols-capsules|Capsules containing 456 mg cocoa flavanols and 315 g of milk (1% fat)
15916207|NCT03526094|Other|Flavanol-banana blend|Fruit blend prepared by mixing 177 g ripe, frozen bananas, 240 g almond milk and a chocolate flavored powder containing 626 mg cocoa flavanols
15916208|NCT03526094|Other|Flavanol-high protein drink|Drink prepared by mixing 225 mL of a chocolate flavored high protein dairy drink with a CF powder containing 533 mg cocoa flavanols
15916209|NCT03526094|Other|Flavanol-berry blend|Flavanol-berry blend prepared by mixing 120 g almond milk, 70 g water, 95 g yogurt, 50 g each strawberries, blueberries, blackberries, raspberries, 105 g crushed ice and a fruit-flavored powder containing 561 mg cocoa flavanols
15916210|NCT03526094|Other|Flavanol-sports drink|Drink prepared by mixing 488 g of a sports drink with a CF powder containing 533 mg cocoa flavanols
15916211|NCT03526094|Other|Flavanol-peanut butter toast|Prepared by mixing 32 g peanut butter with a chocolate flavored powder containing 602 mg cocoa flavanols and spread on 1 slice toasted bread (50 g) and 50 g sliced strawberries
15916212|NCT03526094|Other|Flavanol-oats|Prepared by mixing 40 g quick oats with 237 g boiling water and combined with a chocolate flavored powder containing 602 mg cocoa flavanols
15916213|NCT03526094|Other|Flavanol-yogurt|Prepared by 227 g yogurt (0% fat) mixed with a fruit-flavored powder containing 561 mg cocoa flavanols
15916214|NCT03526094|Other|II- Flavanol drink|Drink prepared by mixing 240 g almond milk with a chocolate flavored powder containing 626 mg cocoa flavanols
15916215|NCT03526094|Other|II- Flavanol drink + banana blend|Drink 1 (Flavanol drink): prepared by mixing 120 g almond milk with 626 mg cocoa flavanols Drink 2 (Fruit blend): prepared by mixing 120 g almond milk blended with 177 g ripe, frozen bananas
15916216|NCT03526081|Other|Chamomile Tea|Chamomile Tea in 300mL hot water
15916217|NCT03526081|Other|Parsley based drink|3.2 g dried parsley in 300mL hot water
15916218|NCT03526081|Other|Parsley Yogurt|3.2 g dried parsley in 100g plain yogurt
15916219|NCT03526081|Other|Apigenin|Apigenin capsule mixed with 300mL hot water
15916220|NCT03526081|Other|Parsley-based drink (II)|3.2 g dried parsley in 300mL hot water
15916221|NCT03526068|Device|SafeZoneUVC|SafeZoneUVC® uses a Krypton Chloride (Kr-Cl) excimer lamp as its light source. The Kr-Cl excimer lamp emits UVC light having a main wavelength of 222 nm when the Kr-Cl exciplex is deactivated to non-excited state molecule in the lamp. This 222 nm UVC light can inactivate bacteria, while the Kr-Cl excimer lamp also emits UVC light having a wavelength of 230 nm or more. SafeZoneUVC® effectively eliminates UVC light with a wavelength of 230 nm or more by incorporating an appropriate optical filter inside the unit and also utilizing an opaque guide to ensure that light is not dispersed beyond the target area.
15916222|NCT03526055|Device|Algovita Spinal Cord Stimulation System|The Algovita™ SCS system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with failed back surgery syndrome, intractable low back pain and leg pain.
15916223|NCT03526042|Drug|Losartan|Competitive blockade of AT1R-antibodies effect by binding to the angiotensin 1 receptor
15916224|NCT03526042|Drug|Enalapril|Renin-angiotensin-aldosterone system (RAAS) blockade without any effect on AT1R-antibodies effect or concentration (control group)
15916225|NCT03526003|Diagnostic Test|Measurement of esophageal pressure|Measurement of esophageal pressure during posture changes and pneumoperotoneum
15916226|NCT03525990|Other|Questionnaires|Quality of life questionnaires on iPads with CHES (Computer-based Health Evaluation System), paper-based questionnaire (EORTC QLQ-COMU26)
15916227|NCT03525977|Procedure|Fascia iliaca block arm|The fascia iliaca block will be performed by the anesthesiologist on call
15916228|NCT03525964|Procedure|Individualized treatment of Acute Achilles tendon rupture.|The most proximal border of the calcaneus and the most distal point of the musculotendinous junction of the Achilles tendon and the medial gastrocnemius muscle is identified and marked on the skin. These two points on the un-injured leg defines the original length of the total Achilles tendon and consist of the free tendon and the fascia [1]. The difference in length between the injure and the un-injured leg determines elongation for the ruptured Achilles tendon. The relative elongation of the ruptured tendon together with overlap of the tendon ends on the cross-sectional area determines the treatment for the patients receiving individualized treatment: 1) patients with 0-6% elongation of the tendon and a minimum of 25% tendon are treated non-operatively 2) patients with 7% elongation or more or less than 25% tendon overlap are treated operatively. The cut-off at 7% elongation is determined for 75% sensitivity and 65% specificity of elongation.
15916229|NCT03525964|Procedure|Non-operative treatment|Circulated cast below the knee in maximal, unforced plantar flexion over the ankel.
15916230|NCT03525964|Procedure|Operative treatment|Open surgery with suture of the ruptured achilles tendon prior to circulated cast below the knee in maximal, unforced plantar flexion over the ankel.
15916231|NCT03525951|Behavioral|Enhanced Milieu Teaching|The parent training will incorporate the EMT strategies of responsive interaction, matched turns, language modeling, and expansions. There will be three, hour-long parent training sessions following the teach-model-coach-review format (TMCR). The TMCR framework teaching component will involve 10 minutes of verbal and visual instruction on the language stimulation target of interest. The teaching component will be followed by 15 minutes of clinician modeling of the target strategies with the child while the parent watches. The parent will then have the opportunity to practice using the strategy during naturalistic interaction with their child. The clinician will provide individualized coaching on the use of the target strategy during this 20-minute, parent-child interaction. Finally, the clinician will review the target strategies and set goals.
15916232|NCT03525951|Other|no intervention comparison group|No intervention for observational (Study 1 and 2) and training (Study 2) data comparison.
15916233|NCT03525938|Procedure|TAP block|Whilst the patient is in the supine position, a high frequency ultrasound probe (10 MH) is placed transverse to the abdominal wall between the costal margin and iliac crest. The needle is introduced in plane of the ultrasound probe directly under the probe and advanced until it reaches the plane between the internal oblique and transversus abdominis muscles. Upon reaching the plane, 2 ml of saline is injected to confirm correct needle position after which 20 ml of levobupivacaine, 25% plus triamcinolone, 80 mg solution is injected for TAP group and 20 ml of saline only is injected for SHAM group.. The transversus abdominis plane is visualized expanding with the injection ( appears as a hypoechoic space)
15916234|NCT03525925|Drug|Ibrutinib|Given PO
15916235|NCT03525925|Other|Laboratory Biomarker Analysis|Correlative studies
15916236|NCT03525925|Biological|Nivolumab|Given IV
15916237|NCT03525912|Drug|Ketamine|continuous infusion of low dose ketamine for postoperative pain
15916238|NCT03525899|Procedure|Pars plana vitrectomy|Pars plana vitrectomy combined with Internal limiting membrane peeling, inverted internal limiting membrane flap insertion into the macular hole, or lens anterior or posterior capsular flap insertion into the macular hole
15916239|NCT03525886|Drug|NBI-74788|Capsule, administered daily.
15916240|NCT03525873|Other|Laboratory Biomarker Analysis|Correlative studies
15916241|NCT03525873|Drug|Methylphenidate|Given PO
15916242|NCT03525873|Other|Physical Activity|Participate in physical activity
15916243|NCT03525873|Other|Placebo|Given PO
15916244|NCT03525873|Other|Quality-of-Life Assessment|Ancillary studies
15916245|NCT03525873|Other|Questionnaire Administration|Ancillary studies
15916352|NCT03525015|Other|An usual booklet about cataract and cataract surgery|Potential participants receive an usual booklet with information about cataract and cataract surgery, and outcome data will be gathered using standardized questions in a structured interview after 2 weeks and 1 year.
15916246|NCT03525860|Procedure|Acupuncture|"The subject is placed in the selected position (lying down or sitting), based on their comfort level. The areas to be needled are prepped with an alcohol swab. Mandatory standards and safety guidelines for acupuncture will be followed.
~The acupuncture treatment protocol will be based on Traditional Chinese Medicine (TCM) theory. The TCM treatment strategy is designed to Benefit the Heart, Tonify Heart Qi and Blood, Calm and Sedate Cardiac Excitability and Regulate the Qi. Current literature supports the use of selected acupuncture points as possibly beneficial in regulating the autonomic nervous system, modulating Heart Rate Variability (HRV), relieving chest pain, and reducing arrhythmias.
~11 sterile, single use, disposable needles will be placed one by one until all needles are in place.
~Needles remain in place for additional 20 minutes or so as the patient remains in the selected position
~."
15916247|NCT03525847|Diagnostic Test|Endosonography|Puncture of the pancreatic solid mass with fine needle aspiration under endoscopic ultrasonographic control. Passage in the same pancreatic mass of first using standard FNA method then contrast enhanced FNA method or vice versa according to the randomization
15916248|NCT03525834|Drug|Everolimus|Everolimus 2.5 mg and 5 mg tablets with dosage regimen of 10 mg orally once daily.
15916249|NCT03525821|Drug|Ketamine Hydrochloride|intranasal use of ketamine 1mg/kg with nitrous oxide
15916250|NCT03525808|Device|AXIOS|Patient will receive either transgastric or transduodenal endoscopic drainage for walled-off necrosis that are adherent to the gastric or bowel wall.
15916251|NCT03525795|Drug|CPI-1205|Administered orally
15916252|NCT03525795|Drug|ipilimumab|Administered intravenously
15916253|NCT03525782|Biological|CAR-T Cells|Using the T cells from the patients to produce anti-MUC1 CAR-T Cells and then the cells will be infused back to the patients.
15916254|NCT03525782|Combination Product|CAR-T combining PD-1 Knockout|Using the T cells from the patients to prepare anti-MUC1 CAR-T Cells and PD-1 knockout T cells, then the cells will be infused back to the patients
15916255|NCT03525782|Biological|PD-1 knockout|Using the T cells from the patients to prepare PD-1 knockout T cells, then the cells will be infused back to the patients
15916256|NCT03525782|Drug|PD-1 mAb|Patients will be treated with an identical course with a FDA approved monoclonal antibody against PD-1
15916257|NCT03525782|Other|Sham control|Patient's T cell will treated ex vivo with modification and then infused back in a similar time course.
15916258|NCT03525769|Diagnostic Test|FibroTouch|"FibroTouch is a non-invasive image-guided integrated detection system, providing an integrated detection and comprehensive evaluation program for hepatic fibrosis and hepatic steatosis.
~The FibroTouch is a completely non-invasive liver testing device that can obtain the following results: 1. Liver Fibrosis: quantitative results of hepatic fibrosis; 2. Fatness: quantitative result of hepatic steatosis; 3. Liver tissue morphology: detected by ultrasound imaging."
15916259|NCT03525743|Device|NICOM (Non invasive cardiac output monitor)|Non invasive hemodynamic device utilizing bioreactance
15916260|NCT03525730|Drug|Valproic Acid|Valproic acid (enteric) 30mg/kg, divided over 2 doses per day, orally on day 1-14.
15916261|NCT03525730|Drug|Pyrimethamine|Pyrimethamine 200mg once daily (QD) orally on day 1 and 100mg on day 2-14.
15916262|NCT03525717|Dietary Supplement|Routine Dinner|Participants will be served dinner at a routine time (18:00), along with with a stable isotope of palmitate to measure fat oxidation overnight.
15916263|NCT03525717|Dietary Supplement|Late dinner|Participants will be served dinner at a late time (22:00), along with with a stable isotope of palmitate to measure fat oxidation overnight.
15916264|NCT03525704|Device|Saline Solution Enriched|Sterile single dose, Preservative Free, PH Balanced, Enriched with IONs rinsing and Insertion Solution
15916265|NCT03525704|Device|Saline Rinse Solution|sterile unit dose non-preserved, 0.9% NaCl (normal saline) solution i
15916266|NCT03525691|Device|Low flow Extracorporeal CO2 removal|Low flow Extracorporeal CO2 removal using a 0.67 m² membrane oxygenator (Lilliput 2) and a specific circuit (HP-X) mounted on a RRT monitor (PrismafleX)
15916267|NCT03525678|Drug|Belantamab mafodotin frozen liquid|Belantamab mafodotin will be available as frozen liquid. Frozen liquid will be available as 30 milligram (mg)/vial solution in a single use vial with unit dose strength of 2.5 or 3.4 mg/kg. Belantamab mafodotin will be administered as IV solution over at least 30 minutes. Frozen belantamab mafodotin will be diluted in 0.9 percent saline and administered via infusion pump.
15916268|NCT03525678|Drug|Belantamab mafodotin lyophilized powder|Belantamab mafodotin will be available as lyophilized powder. Lyophilized powder will be available as 100 mg/vial in single-use vial for reconstitution with unit dose strength of 3.4 mg/kg. Lyophilized belantamab mafodotin will be reconstituted using water for injection and diluted with saline before use.
15916269|NCT03525665|Other|Metabolic activity measured by FDG-PET|To evaluate whether metabolic activity measured by FDG-PET (SUV max) at time of relapse is predictive of patient's outcome.
15916270|NCT03525652|Biological|Therapeutic vaccine|The therapeutic vaccine will be custom prepared ex vivo using the peripheral mononuclear cells from the patient and the vaccine which presented as maturated dendritic cells will be infused back to the patients in 3 times.
15916271|NCT03525652|Biological|PD-1 Knockout T Cells|PD-1 knockout T cells will be custom prepared ex vivo using the white blood cells from the patient and the maturated PD-1 knockout T cells will be infused back to the patients in 3 times.
15916272|NCT03525639|Diagnostic Test|Cardiac Magnetic Resonance|Additional CMR study 2 month after the initial diagnosis of acute myocarditis to assess myocardial inflammation persistence (2-month-CMR).
15916273|NCT03525626|Behavioral|Online Mindfulness-based Tic Reduction|8-week online group mindfulness-based intervention for tics
15916274|NCT03525613|Drug|APL-2|Complement (C3) Inhibitor
15916275|NCT03525613|Drug|APL-2|Complement (C3) Inhibitor
15916276|NCT03525613|Other|Sham Procedure|Subjects will receive a Sham procedure every month
15916277|NCT03525613|Other|Sham Procedure|Subjects will receive a Sham procedure every other month
15916278|NCT03525600|Drug|APL-2|Complement (C3) Inhibitor
15916279|NCT03525600|Drug|APL-2|Complement (C3) Inhibitor
15916280|NCT03525600|Other|Sham Procedure|Subjects will receive a Sham procedure every month
15916281|NCT03525600|Other|Sham Procedure|Subjects will receive a Sham procedure every other month
15916353|NCT03525002|Drug|Bromocriptine|In each FTO genotype group participants will be randomly receive bromocriptine or placebo.
15916523|NCT03523663|Other|no intervention. measure eye movement data|
15916282|NCT03525587|Other|"Use of MAGHD App/MAGHD Framework"|Patients daily related outcomes will be recorded thanks to the development, implementation and validation of a Smartphone app (MAGHD App) integrated with a software framework able to merge patient's daily activities data on well-being status, QoL, physical activities and sexual function with clinical data collected in their record chart (extrapolated from already available Institutional Databases).
15916283|NCT03525574|Drug|VX-445|Fixed-dose combination (FDC) tablets (VX-445/TEZ/IVA)
15916284|NCT03525574|Drug|TEZ|FDC tablets (VX-445/TEZ/IVA)
15916285|NCT03525574|Drug|IVA|FDC tablets (VX-445/TEZ/IVA)
15916286|NCT03525574|Drug|IVA|IVA tablet
15916287|NCT03525561|Drug|Acetazolamide Pill|Subjects will take acetazolamide pill (Diamox), 500 mg/ day, and assess effect on exercise performance during 30-hour exposure to 3,500 m simulated altitude.
15916288|NCT03525561|Drug|Placebo pill|Subjects will take placebo pill and then we will assess exercise performance during 30-hour exposure to 3,500 m simulated altitude.
15916289|NCT03525548|Drug|VX-445/TEZ/IVA|Participants received VX-445/TEZ/IVA orally once daily in the morning.
15916290|NCT03525548|Drug|TEZ/IVA|Participants received TEZ/IVA orally once daily in the morning.
15916291|NCT03525548|Drug|IVA|Participants received IVA orally once daily in the evening.
15916292|NCT03525548|Drug|Placebo|Participants received placebo matched to VX-445/TEZ/IVA orally once daily in the morning.
15916293|NCT03525548|Drug|Placebo|Participants received placebo matched TEZ/IVA orally once daily in the morning.
15916294|NCT03525535|Other|data collection|data from patient included will be collected during the study
15916295|NCT03525522|Device|Nd:YAG Laser|Three sessions of Nd:YAG treatment every two weeks.
15916296|NCT03525522|Drug|Topical corticosteroid Diprosone|3 months of topical corticosteroids Diprosone
15916297|NCT03525509|Drug|Methadone hydrochloride|Epidural bolus of 4mg of preservative free methadone hydrochloride (4mL of 1mg/mL solution)
15916298|NCT03525509|Drug|Morphine Sulfate|Epidural bolus of 4mg of preservative free morphine sulfate (4mL of 1mg/mL solution)
15916299|NCT03525483|Diagnostic Test|Ultrasound for renal resistivity index measurement|"Collection of urine over 3 hours for creatinine clearance measurement, with serum creatinine in parallel with urine collection to calculate measured creatinine clearance and estimate glomerular filtration rate Evaluation of the renal vascular resistance index in Doppler ultrasound by a resuscitator trained in the technique at the time of inclusion.
~Collection of demographic, clinical and biological data for inclusion of the patient such as weight, age, sex, arterial lactatemia, arterial pH, volume status, use of diuretics, use of vasopressors, use of nephrotoxic drugs ..."
15916300|NCT03525470|Biological|Water|150 mil of water was drunk on two occasions
15916301|NCT03525470|Other|No drink|Although body weight lost no drink consumed
15916302|NCT03525457|Procedure|Non Surgical Periodontal Therapy|Non Surgical Periodontal Therapy in 2 to 3 sessions
15916303|NCT03525444|Drug|VX-445/TEZ/IVA|Participants received VX-445/TEZ/IVA orally once daily in the morning.
15916304|NCT03525444|Drug|IVA|Participants received IVA orally once daily in the evening
15916305|NCT03525444|Drug|Placebo|Participants received placebo matched VX-445/TEZ/IVA orally once daily in the morning and placebo matched to IVA orally once daily in the evening.
15916306|NCT03525431|Diagnostic Test|Whole Exome Sequencing|Whole Exome Sequencing is a form of Next Generation Sequencing allowing investigators to assess the coding regions of many thousands of genes to find variants implicated in disease.
15916307|NCT03525418|Biological|Longeveron Mesenchymal Stem Cells|Allogeneic bone marrow-derived mesenchymal stem cell
15916308|NCT03525405|Drug|napabucasin|Single 240 mg dose containing 100 μCi of 14C-napabucasin will be administered with 240 mL of water following an overnight fast.
15916309|NCT03525392|Drug|177Lu-3BP-227 (also called 177Lu-IPN01087)|The cumulative activity of the treatment investigational medicinal product (IMP) formulation will be administered in two intravenous (i.v.) infusions separated by at least 4 weeks (28 days). Up to 6 administrations can be given (2 cycles plus 4 optional additional)
15916310|NCT03525379|Drug|Resveratrol|"Subject participation will be approximately 10 weeks in duration. Participants will be randomized to receive one treatment: either resveratrol for 8 weeks OR placebo for 8 weeks. There will be a 2-week run-in period prior to the treatment period.
~The schedule for the study is:
~Week 0 Screening and randomization Weeks 1-2 Run-in; no treatment Weeks 3-10 Treatment Phase (resveratrol or placebo)"
15916311|NCT03525379|Drug|Placebo|Participants will be randomized to receive one treatment: either resveratrol for 8 weeks OR placebo for 8 weeks. There will be a 2-week run-in period prior to the treatment period.
15916312|NCT03525366|Other|Radiofrequency ablation|Radiofrequency Ablation (RFA) as an intervention is part of standard of care at Memorial Herman Hospital, Houston.
15916313|NCT03525353|Other|Endoscopic retrograde cholangiopancreatography - No Intervention have been used other than standard of care|No intervention has been used and this is an observational study
15916314|NCT03525340|Behavioral|Peer Navigation|Peer navigators help participants identify barriers that pose challenges to the participant's engagement in care and adherence and help develop an overall action plan for addressing these barriers by identifying specific changes that can be made/attempted to overcome an identified barrier. This may involve accompanying a participant to their social services/health appointments, or assisting a participant with disclosure of her HIV status to a family member or friend. The overall goal is to develop knowledge of social/HIV-related health services and good problem-solving skills in order to tackle multiple, potentially overlapping barriers. Over time, participants are encouraged to take increasing degrees of responsibility for identifying and implementing their own problem-solving strategies.
15916315|NCT03525327|Other|Line Dance Class|"Line or party dances to be taught will include:
~Electric Slide (Mainland USA)Hukilau (Hawaii)Cupid Shuffle (Mainland USA)Poco Poco (Philippines)Cha Cha Slide (Mainland USA)Tush Push (Mainland USA)Trojan Crawl (Mainland USA)Wobble (Mainland USA)Goyang Maumere (Indonesia)"
15916316|NCT03525301|Radiation|standard treatment|3000 cGy in 10 daily fractions
15916317|NCT03525301|Radiation|short course treatment|1800 cGy in 4 fractions administered twice a day
15916354|NCT03525002|Other|Placebo|In each FTO genotype group participants will be randomly receive bromocriptine or placebo.
15916355|NCT03524989|Device|Hyperbaric Oxygen Therapy|40 daily sessions, 60 minutes of 100% oxygen at pressure of 2 ATA each, five days a week for 2 months.
15916318|NCT03525288|Radiation|PSMA -PET/CT simulation|"PET/CT simulation.
~If no additional lesions detected: RT as planned per standard care.
~If PSMA-PET/CT imaging consistent with oligometastases (1-5 lesions): all lesions must be treated with definitive RT.
~If PSMA-PET/CT imaging consistent with widely metastatic disease (>5 lesions): treatment of all detected disease with RT is not recommended, but treatment of the primary site as initially planned is encouraged."
15916319|NCT03525288|Radiation|Standard-care simulation|No PSMA-PET/CT as part of RT treatment planning.
15916320|NCT03525275|Device|Battlefield Acupuncture|Battlefield Acupuncture uses ASP semi-permanent needles inserted into their ears for pain attenuation in 5 known points. Both groups receive their respective post-surgical rehabilitation protocols
15916321|NCT03525275|Procedure|Post-surgical shoulder protocol|Surgery specific post-surgical physical therapy protocol
15916322|NCT03525262|Radiation|30Gy (Gray) planning target volume (PTV)|PTV1_30Gy represents a 3mm expansion on the prostate (and proximal seminal vesicle per physician discretion), excluding the neurovascular structures on the side to be spared (left or right). PTV1 will receive 6 Gy per fraction for 5 fractions (30 Gy).
15916323|NCT03525249|Dietary Supplement|nutraceutical|Subjects will consume a capsule for eight weeks
15916324|NCT03525236|Other|Tasting of flavours|"Each patient will taste 5 products, in sequential-monadic test, randomized, one by one.
~Patients will take few sips of each study product, ideally in isolation (avoid influence of other patients)
~For each product tasted the subjects will be asked to answer a questionnaire including 1 question on the palatability of the product using a 10-point hedonic scale and a more detailed organoleptic evaluation of the product.
~Between product tastings, participants will have a 10 minutes break to rinse their mouth and fill in a questionnaire assessing sensory changes"
15916325|NCT03525223|Procedure|Change of dialysate [Na+]|Stepwise modulation of dialysate sodium concentration by 1-2 mmo/l per week
15916326|NCT03525210|Biological|9-valent HPV vaccine|Vaccination
15916327|NCT03525197|Dietary Supplement|Whey protein-based supplement|High quality protein supplement to be consumed twice daily
15916328|NCT03525197|Dietary Supplement|Collagen protein-based supplement|Lower quality protein supplement to be consumed daily
15916329|NCT03525184|Other|Additional protein and multi-nutrient beverage|During SR+, participants will consume a multi-nutrient beverage and additional protein (~1.5 grams·kg-1 body weight·day-1 versus the lower end of MDRI of ~0.9 grams·kg-1 body weight·day-1) during and after the period of sleep restriction. The multi-nutrient beverage contains arginine, glutamine, vits C & D, zinc and omega-3 fatty acids (DHA and EPA).
15916330|NCT03525184|Other|Placebo beverage|The placebo beverage (NS and SR) will be composed of a commercially-available artificially sweetened (e.g., containing aspartame, splenda or another artificial sweetener) beverage powder base and grapefruit extract (i.e., naringen) and/or quinine (i.e., a common ingredient found in tonic water).
15916331|NCT03525171|Diagnostic Test|euglycemic hyperinsulinemic clamp|In addition to auxological and baseline biochemical parameters, we performed the clamp to evaluate insulin sensitivity (M-value) at baseline (GHD group and controls) and after 12 months of GH treatment (GHD group).
15916332|NCT03525158|Behavioral|Brief cognitive intervention|A one-session intervention with a researcher including a simple cognitive task (a memory cue, 10 minutes time gap and ca. 20 minutes of Tetris game play) with instructions to engage in the task self-guided in the subsequent week.
15916333|NCT03525132|Procedure|Laser Doppler Velocimetry + Optic Adaptative Camera|Fluxometry measure while subject is sitting in front of the optic adaptative camera
15916334|NCT03525119|Biological|TDV|TDV SC injection
15916335|NCT03525119|Biological|HAV Vaccine|HAV Vaccine IM injection.
15916336|NCT03525119|Biological|TDV Placebo|Placebo-matching (normal saline (0.9% NaCl) SC injection.
15916337|NCT03525119|Biological|HAV Vaccine Placebo|Placebo-matching (normal saline (0.9% NaCl) IM injection.
15916338|NCT03525106|Behavioral|Booklet|Receive positive psychology manual
15916339|NCT03525106|Behavioral|Exercise Intervention|Complete positive psychology exercises
15916340|NCT03525106|Other|Quality-of-Life Assessment|Ancillary studies
15916341|NCT03525106|Other|Survey Administration|Ancillary studies
15916342|NCT03525106|Behavioral|Telephone-Based Intervention|Participate in phone sessions
15916343|NCT03525093|Behavioral|Hypnosis|"5 session of group hypnosis, each 90 minutes, to reduce subjective levels of stress, improve coping with stress. Additional audiotapes of hypnosis sessions as homework.
~Participants receive a health education booklet on improving coping with stress."
15916344|NCT03525093|Behavioral|Health education|Participants receive a health education booklet on improving coping with stress.
15916345|NCT03525080|Diagnostic Test|PET imagery|Every patients will have a PET imagery in addition to standard MRI
15916346|NCT03525067|Other|Bile sampling for bacterial examination|At the beginning of pancreaticoduodenectomy, patients had bile sampling from the gallbladder or from the common bile duct for bacterial examination and study of susceptibility to antibiotics.
15916347|NCT03525041|Procedure|CABG|CABG will be performed using standard surgical techniques. All procedures will be performed with cardiopulmonary bypass(CPB). Saphenous vein(SV)will be used as conduit but harvesting methods will not be prescribed, and utilization of the left internal mammary artery (LIMA) is recommended when a left anterior descending (LAD) graft is indicated. The technical details of bypass grafting will not be prescribed. Complete revascularization will be performed, judging by the surgical investigator.
15916348|NCT03525041|Procedure|mitral valve annuloplasty|Surgical techniques for mitral valve annuloplasty may need to be adjusted at the discretion of the surgeon, as based on intra-operative findings that may not be previously recognized in the pre-operative evaluation.
15916349|NCT03525028|Drug|Metformin|The investigators assumed that the combination therapy of metformin and glucocorticoids can decrease glucocorticoids side effects and synergia the anti-inflammatory and immune inhibitory effect of glucocorticoids. So the investigators use metformin in the experimental group.
15916350|NCT03525028|Drug|Placebo|The investigators use placebo in the control group.
15916351|NCT03525015|Other|A decision aid booklet about cataract surgery choice|Potential participants receive a decision aid booklet with information about cataract surgery choice, and outcome data will be gathered using standardized questions in a structured interview after 2 weeks and 1 year.
15916356|NCT03524989|Device|SHAM treatment|40 daily sessions, 60 minutes of 21% oxygen at pressure of 1.01 ATA each, five days a week for 2 months.
15916357|NCT03524976|Device|Squid|"SQUID™ is injected into the vascular site to be treated, under fluoroscopic control. DMSO dissipates in the blood and causes precipitation of EVOH in which the tantalum powder is trapped. It then forms a consistent spongy embolus.
~This embolus solidifies from the outside inwardly while moving distally in the vessel. The non-adhesive character of the embolus allows slow and controlled injections while leaving in place the microcatheter."
15916358|NCT03524963|Drug|Cilostan CR Tab.|Cilostan CR Tab. 200mg once a day for 5 days
15916359|NCT03524963|Drug|Pletaal SR Cap.|Pletaal SR Cap. 200mg once a day for 5 days
15916360|NCT03524950|Drug|Dexmedetomidine|Ninety patients will be assigned to three groups. Group A add saline in general anesthesia laparoscopic hysteromyoma surgery. Group B add dexmedetomidine 1μg/Kg10minutes as loading dose, followed by 0.7μg/Kg/h for maintenance.Group C add dexmedetomidine 0.7μg/Kg10minutes as loading dose, followed by 0.5μg/Kg/h for maintenance.
15916361|NCT03524937|Drug|MELATONIN (HIGH DOSE)|Enteral melatonin (3mg) will be given at 21:00h daily, starting on the day of enrolment until ICU discharge, death, or up to 14 days
15916362|NCT03524937|Drug|MELATONIN (LOW DOSE)|Enteral melatonin (0.3mg ) will be given at 21:00h daily, starting on the day of enrolment until ICU discharge, death, or up to 14 days
15916363|NCT03524937|Drug|PLACEBO|Study drug will be given at 21:00h daily, starting on the day of enrolment until ICU discharge, death, or up to 14 days.
15916364|NCT03524911|Behavioral|CHFFF nutrition education|
15916365|NCT03524898|Drug|Nab-Paclitaxel|150 mg/m2 / 125 mg/m2
15916366|NCT03524898|Drug|gemcitabine|1000 mg/m2
15916367|NCT03524885|Procedure|Short implant placement|"Ten patients will be randomly selected for the short implants option, 2 or 3 implant 4-5 mm length and 4 mm diameter (Syra Short, Sweden & Martina, Padua, Italy) will be positioned. The healing cap will be immediately connected and a vycril suture will be done after soft tissue reflection.
~After three months an acrylic screw-retained bridge will be delivered. After further three months, a definitive restauration with a metal ceramic bridge will be seated."
15916368|NCT03524885|Procedure|Bone regeneration with longer implants|"Ten patients will be randomly assigned to the regenerative group, 2 or 3 implant from 10 to 13 mm length intentionally exposed putting the implant platform 2 or 3 mm apical to CEJ of the adjacent tooth will be inserted.
~A horizontal and vertical regeneration following GBR technique will be performed using not-resorbable PTFE titanium reinforced membrane (Cytoplast Osteogenics, US) fixed by titanium pins or miniscrews to ensure the perfect stability (Pro-fix, Cytoplast Osteogenics, US)."
15916369|NCT03524872|Device|Original CAD/CAM prosthetic abutment|Original (Sweden&Martina) CAD/CAM abutments will be screwed to the implants at 32N/cm.
15916370|NCT03524872|Device|Compatible CAD/CAM abutment|Compatible (New Ancorvis) CAD/CAM abutments will be screwed to the implants at 32N/cm.
15916371|NCT03524872|Procedure|Local anesthesia|Infiltration of 4% articaine with 1:100,000 adrenalin (Inibsa).
15916372|NCT03524872|Drug|Painkillers|Patients will be prescribed ibuprofen 600 mg three times per day for five days
15916373|NCT03524872|Drug|Mouthwashes|Patients will be prescribed mouth-rinse with chlorhexidine 0.12% twice daily starting 3 days prior to surgery and for 2 weeks afterward
15916374|NCT03524872|Device|Implant placement|Dental implants (Sweden & Martina, Padua, Italy) will be placed at crestal level and according to the manufacturer's instructions.
15916375|NCT03524846|Drug|Ascorbic Acid 300 MG|Ascorbic acid 300 mg was administered intravenously for 5 minutes after each dialysis session, three times per week for 12 weeks.
15916376|NCT03524846|Drug|Ascorbic Acid 600 MG|Ascorbic acid 600 mg was administered intravenously for 5 minutes after each dialysis session, three times per week for 12 weeks.
15916377|NCT03524846|Drug|Normal saline|Normal saline was administered intravenously for 5 minutes after each dialysis session, three times per week for 12 weeks.
15916378|NCT03524833|Drug|Metronidazole|Twenty patients receive intraluminal Metronidazole eradication of H. pylori.
15916379|NCT03524833|Drug|Lansoprazole, Amoxicillin, Metronidazole|Patients fail to achieve intraluminal eradication of H. pylori will be assigned to the oral antibiotic triple therapy which contains Lansoprazole, Amoxicillin and Metronidazole for 14 days.
15916380|NCT03524820|Drug|Cetuximab|Administration of drug
15916381|NCT03524807|Device|Electrophysiologic therapy|Pelvic floor electrophysiological therapy is used after common gynecologic surgery to record anal exhaust time and micturition time after surgery and endometrium recovery of intrauterine adhesions.For intrauterine adhesions patients, Drug: Aspirin(low dose of Aspirin after operation)Device: intrauterine balloon (insert intrauterine balloon after operation)
15916382|NCT03524768|Diagnostic Test|skin laser speckle contrast imaging and video-capillaroscopy|Evaluation of endothelial-dependent microvascular reactivity and capillary recruitment
15916383|NCT03524755|Other|Exercise|
15916384|NCT03524742|Other|Avocado-Mediterranean Diet|Mediterranean diet including 1/2 portion of Hass avocado per day, considering a minimum 35% of calories as fat (22% MUFA fat, 6% PUFA fat, and ±10% saturated fat), 15% proteins, and a maximum of 50% carbohydrates.
15916385|NCT03524742|Other|Control-Group Diet|A low fat-high complex carbohydrate diet, during 3 months.
15916386|NCT03524729|Device|Rocker bottom shoe|Walking shoe with a anterior posterior rocker sole.
15916387|NCT03524729|Device|Ankle foot orthosis|Dynamic carbon fiber ankle brace.
15916388|NCT03524729|Device|Standard walking shoe|Standard walking shoe (control shoe) with no rocker sole.
15916389|NCT03524716|Behavioral|Fitbit and Text Messages|Physical activity tracker wristband and daily text messages delivered to the participants' phones.
15916390|NCT03524703|Other|chewing gum|Chewing gum four times per day for 5 days, 15 minutes each time.
15916391|NCT03524690|Dietary Supplement|Energy Balance|Energy Balance Sufficient food provided to maintain energy balance.
15916392|NCT03524690|Dietary Supplement|Negative Energy Balance|Negative Energy Balance Insufficient food provided to maintain energy balance resulting in negative energy balance.
15916393|NCT03524677|Diagnostic Test|Liquid Biopsy|K-RAS, CDKN2A, SMAD4 and TP53 mutation on circulating cfDNA
15916394|NCT03524664|Behavioral|Tuning In to kids intervention|"The Tuning Into Kids Program involves:
~Meeting in a small group with other caregivers raising children with FASD.
~8-week program that meets weekly for 2 hours at Mt. Hope Family Center or other community location.
~Learn and practice an approach of responding to children's emotions and behavior."
15916395|NCT03524651|Drug|Ferrous Sulfate|Blisters of 10 capsules containing 150 mg of ferrous sulfate.
15916396|NCT03524651|Drug|Fe-ASP|Boxes of 10 vials of 15 ml containing 800 mg of Iron protein acetyl aspartate.
15916397|NCT03524651|Drug|Ferrous Sulfate|Boxes of 10 vials of 15 ml containing inactive ingredients of Omalin.
15916398|NCT03524651|Drug|Fe-ASP|Blisters of 10 capsules containing inactive ingredients of Microfer.
15916399|NCT03524638|Other|Visbiome|Colorectal surgery plus administration of Visbiome on post-operative day 2.
15916400|NCT03524638|Procedure|Colorectal Surgery|Colorectal surgery alone
15916401|NCT03524612|Drug|eltrombopag|eltrombopag is for oral use and comes in 12.5, 25, 50 and 75 mg tablets; prescribed dose is taken once daily
15916402|NCT03524599|Other|Intervention municipality|In intervention municipalities, primary health care centres and the providers working within them will receive training and a range of community support mechanisms.
15916403|NCT03524586|Procedure|Ipsilateral rotation of head|Ipsilateral rotation of head against fixed tube
15916404|NCT03524586|Procedure|Contralateral rotation of head|Contralateral rotation of head against fixed tube
15916405|NCT03524573|Procedure|Appendectomy|Appendectomy is the surgical removal of the appendix.
15916406|NCT03524560|Other|Comprehensive geriatric assesment|Comprehensive Geriatric Assesment (CGA) consisting of detailed history and examination, drug consumption information, Body Mass Index (BMI), Waist Circumference (WC), Timed Up & Go test (TUG), Clock Drawing Test (CD), Activities of Daily Living and Instrumental Activities of Daily Living scales (ADL & IADL), Mini Mental State Examination (MMSE), Tinetti Gait and Tinetti Balance scores (TG &TB), 30 items Geriatric Depression Scale (GDS) was performed for each subject
15916407|NCT03524547|Device|J shaped stylet used for endotracheal intubation|After inserting a stylet into the endotracheal tube, the tube will be molded into a J-shape.
15916408|NCT03524547|Device|60-degrees stylet used for endotracheal intubation|After inserting a stylet into the endotracheal tube, the tube will be bent 60-degrees.
15916409|NCT03524534|Other|Telephone Call|A phone call will take place within 7 days of discharge by a Kaiser Permanente Heart Failure Care Manager from the Kaiser Permanente Heart Failure Chronic Care Management Program.
15916410|NCT03524534|Other|In-Person Primary Care Clinical Follow-Up Visit|This will be a standard in-person clinic visit with the subject's primary care physician within 7 days of discharge, with no structured heart failure protocol.
15916411|NCT03524521|Behavioral|Interval Training|Interval training is prescribed 3 days per week using 5 body weight exercises in a progressive fashion.
15916412|NCT03524521|Behavioral|Standard of Care|Walking prescribed to meet current exercise guidelines; 150 minutes per week.
15916413|NCT03524508|Drug|Onivyde|The recommended dose and regimen of Onivyde is 70 mg/m2 intravenously over 90 minutes, followed by dl-LV 400mg/m2 or l-LV 200mg/m2 intravenously over 30 minutes, followed by 5-FU 2400 mg/m2 intravenously over 46 hours, administered every 2 weeks.
15916414|NCT03524508|Drug|5-FU/LV|The recommended dose and regimen of dl-LV 400mg/m2 or l-LV 200mg/m2 intravenously over 30 minutes, followed by 5-FU 2400 mg/m2 intravenously over 46 hours, administered every 2 weeks
15916415|NCT03524482|Behavioral|SmokeFreeText|"SmokefreeTXT is a 6-8 week fully automated text-based cessation intervention. The program is free to U.S. subscribers who have a mobile phone, and is available on smokefree.gov or by texting QUIT to short code 47848. Participants are encouraged to set a quit date within the next 14 days, followed by count-down messages leading to the quit date. Starting on the quit date, participants receive 6 weeks of intervention text messages, and assessment questions (mood, cravings, smoking status). The message library contains 166 messages and 41 behavior change techniques,40 which are delivered at the greatest frequency during the first 2 weeks and taper over time. When in need of assistance, participants can text one of 3 keywords (MOOD, CRAVE, or SLIP) to receive a relevant message from the system. Participants can opt-out by texting STOP at any time. With informed consent, we will be able to access the SmokefreeTXT data for these participants."
15916416|NCT03524482|Behavioral|Path2Quit|Path2Quit will deliver 20-60 second video clips by multimedia messaging service. The message library will include 75-170 messages. Written text messages will be limited to brief phrases to indicate the topic of the video. Messages will be pushed to participants in the morning, in the afternoon, and 2 hours before the reported usual bedtime. The cultural adaptations will be infused throughout the video segments. Topics include deep structure: race and smoking in general, African American smoking statistics; norms for smoking; concerns about nicotine replacement/medication; family/collectivism; unique stressors; racism/discrimination, depression; co-morbid addiction; neighborhood/environmental influences; menthol cigarettes; race-specific weight issues and concerns; and working as a community against the tobacco industry.
15916417|NCT03524456|Other|Home blood pressure monitoring|Participants would use a blood pressure device at home, that sends the readings automatically to the health center via SMS. The physicians would use this tool for medication management or rescheduling visits.
15916418|NCT03524443|Behavioral|Art Therapy treatment|"The main objective is to describe the evolution at 3 months on the alexithymic dimension in the course of a treatment in art therapy, in patients with anorexia nervosa or bulimia.
~Art therapy is a generic term grouping different artistic disciplines adapted and used for therapeutic purposes. It is through commitment to creative work that the therapeutic work of elaboration and reflection takes place in contrast to verbal psychotherapies and mediated psychotherapies that use speech as the main therapeutic tool. All forms of practice referring to categories of art can be used: painting, music, modeling, dance, theater and writing"
15916419|NCT03524430|Procedure|Core needle biopsy|"1st core needle biopsy for RDA (2 specimens): Time Point: 35 +/-4 days after initiation of chemotherapy.
~If no change is made to the therapy, a second biopsy (2 specimens) will be performed at 55 +/- 5 days after therapy initiation.
~If there is a change of drugs, the second biopsy (2 specimens) will be performed at ~2-3 weeks after initiation of new drugs; Timing by type of drug schedule 3-weekly: at 16 days +/- 2 days, Bi-weekly: at day of 2nd dose preferably before drug admin., Weekly: at day of 4th dose preferably before drug admin."
15916420|NCT03524417|Biological|Equine rabies immunoglobulin injection on day 7|The patients with WHO category III rabies exposure, who have received first dose of rabies vaccination a week before and have not received rabies immunoglobulin were enrolled. Blood for Rabies neutralizing antibody titers (RNab) would be examined on day 0. On the same day, Equine rabies immunoglobulin (ERIG) at the dosage of 40 IU/kg would be injected into and around the wound as much as possible and the rest would be injected intramuscularly at the site distance from rabies vaccine. Then blood for RNab would be serially examined on day 7, 14, 90, 365.
15916421|NCT03524404|Behavioral|6 Week Intervention|Weekly interactive webinars based on the DPP curriculum at senior center.
15916422|NCT03524391|Behavioral|Counselling based on yoga|Counseling sessions were given as one-on-one and group to patients based on yoga philosophy and therapy.
15916423|NCT03524391|Drug|Chemotherapy|Usual Care group had standard chemotherapy regimens
15916424|NCT03524378|Behavioral|Ergonomic and movement modifications|Introduction of basic ergonomic and self-management principles, participants will review video clips of the prioritized and revised solutions. Adjustments in work tasks, movement strategies or self-management techniques will be self selected by workers after an educational session using videotapes of work processes.
15916425|NCT03524365|Procedure|RYGB|Roux-&-Y Gastric Bypass (RYGB) involves the use of a surgical stapler to create a small and vertically oriented gastric pouch with a volume of 30 ml. The upper pouch is completely divided by the gastric remnant and is anastomosed to the jejunum, 75 cm distally to the Treitz's ligament , through a narrow gastrojejunal anastomosis in a Roux-en-Y fashion. Bowel continuity is restored by an entero-entero anastomosis, between the excluded biliary limb and the alimentary limb, performed at 100 cm from the gastrojejunostomy. Lifestyle modification counselling is provided to each patient.
15916426|NCT03524365|Procedure|SG|The SG is created using a linear stapler with two sequential 4.8/60-mm green load firings for the antrum, followed by two or three sequential 3.5/60-mm blue loads for the remaining gastric corpus and fundus. The stapler is applied alongside a 48-Fr calibrating bougie. The resection line is performed avoiding the ''critical area'' by resecting the fundus 1.5 cm from the angle of His. Staple lines are buttressed with bovine pericardial strips. The resected stomach is grasped at the antral tip by a laparoscopic grasper and retrieved through one of the trocar sites. A methylene blue dye test by a nasogastric tube is routinely performed at the end of the procedure. The residual gastric remnant capacity is 60-80 ml. Drains are not routinely placed, and the nasogastric tube is removed at the end of the procedure. Upper gastrointestinal contrast (Gastrografin) study is performed on the first postoperative day. Lifestyle modification counselling is provided to each patient.
15916427|NCT03524365|Other|Intensive Lifestyle Modification|"Resting calorie requirements will be calculated via the Harris Benedict equation (24) and an activity factor, and subjects will be instructed not to change their activity level other than that suggested by physicians during the study. The diet will contain 1/3 kcal less than the calculated energy expenditure and 30% fat of which 10% saturated, 55% lower glycemic index carbohydrates and 15% proteins.
~The participants will be encouraged to gradually increase their walking to achieve 10,000 steps per day. A moderate intensity physical activity program of 1 hour of aerobic exercise 2-3 hours per week will be recommended to all subjects. Their physical activity will be assessed by IPAQ-SF as reported below."
15916428|NCT03524352|Other|fecal microbiota|fecal microbiota in suspension
15916429|NCT03524352|Other|Placebo|sterile saline
15916430|NCT03524339|Drug|Placebo oral capsule|Tamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention.
15916431|NCT03524339|Drug|Tamsulosin|Tamsulosin or placebo will be given for 3 days prior to surgery and one week after surgery to determine its effects on postoperative urinary retention.
15916438|NCT03524313|Diagnostic Test|End tidal carbon monoxide|"Evaluation of cardiac output estimated by transthoracic echocardiography and end tidal carbon monoxide
~Evaluation of cardiac output estimated by transthoracic echocardiography and portal veinous velocity
~Evaluation of femoral veinous velocity"
15916439|NCT03524300|Procedure|Robotic Assisted Total Gastrectomy|After exclusion of T4b, bulky lymph nodes, or distant metastasis case,robotic assisted total gastrectomy will be performed in the experimental group.
15916440|NCT03524300|Procedure|Laparoscopic Assisted Total Gastrectomy|After exclusion of T4b, bulky lymph nodes, or distant metastasis case,laparoscopic assisted total gastrectomy will be performed in the experimental group.
15916441|NCT03524287|Procedure|Robotic Assisted No.10 Lymph Node Dissections|After exclusion of T4b, bulky lymph nodes, or distant metastasis case et al. Robotic assisted spleen-preserving No.10 lymph node dissections will be performed with curative treated intent in patients with locally advanced upper third gastric adenocarcinoma
15916442|NCT03524274|Biological|Activated CIK and CD3-MUC1 Bispecific Antibody in Treating colorectal cancer|CIK cells was activated by PD-1 inhibitor and bispecific antibody of anti-CD3/MUC1
15916443|NCT03524274|Procedure|Cryotherapy|the maximum tumor length≥2 cm，cool down the lesion,result in degeneration, necrosis or loss of the lesion.
15916444|NCT03524261|Biological|Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Breast Cancer|CIK cells was activated by PD-1 inhibitor and bispecific antibody of anti-CD3/MUC1
15916445|NCT03524261|Procedure|cryotherapy|the maximum tumor length≥2 cm，cool down the lesion,result in degeneration, necrosis or loss of the lesion.
15916446|NCT03524248|Radiation|Image guided radiation therapy|Real-time 4D video imaging guidance with combination use of cone-beam computerized tomography (CBCT) useful for daily setup and target motion tracking in advanced image-guided radiotherapy (IGRT).
15916447|NCT03524235|Radiation|Total Body Irradiation|Pre-Transplantation Total Body Irradiation
15916448|NCT03524235|Procedure|Haploidentical Stem Cell Transplantation|Haploidentical Stem Cell Transplantation
15916449|NCT03524235|Biological|CD56-Enriched Donor Lymphocyte Infusion|CD56-Enriched Donor Lymphocyte Infusion
15916450|NCT03524235|Drug|Bendamustine|Pre-Transplantation Bendamustine
15916451|NCT03524235|Drug|Fludarabine|Pre-Transplantation Fludarabine
15916452|NCT03524235|Drug|Rituximab|Pre-Transplantation Rituximab (Rituximab for lymphoma diagnosis only)
15916453|NCT03524222|Other|Home Hospitalization|See above
15916454|NCT03524209|Device|Percutaneous instrumentation of the thoracolumbar spine|The spine is stabilized cranially and caudally of the level of spondylodiscitis. The percutaneous instrumentation consists of a rod and pedicle screw construct. The vertebrae are instrumented through minimal skin incisions using a fluoroscopic guidance or a spinal navigation system based on 3D imaging.
15916520|NCT03523689|Procedure|Bronchoscopy|Undergo bronchoscopy
15916455|NCT03524209|Other|Brace|Brace treatment is associated in patients presenting back pain and a risk for vertebral body collapse due to infection with subsequent kyphotic deformity of the thoracolumbar spine
15916456|NCT03524196|Other|Manage Your Life Online (MYLO)|"Manage Your Life Online (MYLO) is accessed online using a username and password. Client's type into the MYLO conversation box about a problem they are currently experiencing. MYLO operates by analysing the client's input of text for key terms and themes. It responds with questions about the problem aimed at encouraging higher level awareness.
~Participants will decide how often to use the MYLO programme over a two week period. This is likely to be a reasonable length of time to allow at least one use of the programme with no upper limit on usage."
15916457|NCT03524183|Behavioral|Virtual Fitness Buddy Ecosystem|The Virtual Fitness Buddy Ecosystem allows parents to stay involved in the intervention and support their children's PA efforts even when they cannot be with their children. A virtual pet, designed to mimic human-pet relationships in the physical world, will guide children to set and meet PA goals and offer tailored support. In collaboration with YMCA, 480 children and 480 parents in 24 afterschool programs will be randomly assigned to treatment and control groups. Afterschool programs in the treatment group will receive the Ecosystem intervention for 6-months; afterschool programs in the control group will not experience the Ecosystem. All children will complete baseline assessments, a 3-month posttest, and a 6-month and 12-month follow up. Parents and children will provide self-report data on their perceived social support, motivation, and PA self-efficacy. PA will be assessed with activity monitors, which children will wear throughout the project.
15916458|NCT03524170|Drug|Bintrafusp Alfa|Given IV
15916459|NCT03524170|Radiation|Radiation Therapy|Undergo radiation therapy
15916460|NCT03524157|Drug|PRO-087|The intervention period consists of a therapy with PRO-087administered 4 times a day in the waking period for 10 days. with a security call to day 13.
15916461|NCT03524157|Drug|Systane Ultra|The intervention period with active comparator drug consists of a therapy with systane administered 4 times a day in the waking period for 10 days. with a security call to day 13.
15916462|NCT03524157|Drug|Xyel Ofteno|The intervention period with active comparator drug consists of a therapy with Xyel administered 4 times a day in the waking period for 10 days. with a security call to day 13.
15916463|NCT03524144|Other|gastroscopy|Two endoscopists performed upper gastrointestinal endoscopy and biopsy on all patients; and histological review was performed by two pathologists. From each patient, 10 specimens were taken from 6 areas in the upper gastrointestinal tract and basic informations was collected.
15916464|NCT03524131|Other|risk-framed leaflet|2-sided leaflet, emphasizing health risks of not going to the NHS Health Check
15916465|NCT03524131|Other|benefits-framed leaflet|2-sided leaflet, emphasizing benefits of attending an NHS Health Check
15916466|NCT03524131|Other|current national leaflet|4-sided leaflet
15916469|NCT03524105|Behavioral|Program for Parents (Parenting Program)|Program for Parents (Parenting Program) is implemented by a mental health professional and offered to groups of ~15 parents during the school day and during after school hours. The Program for Parents includes 2-hour sessions provided weekly over a 4-month period. The Program for Students (Friends School Social Emotional Learning Program) is implemented by classroom teachers in the classroom with 90 minute lessons and activities once a week for 14 weeks
15916470|NCT03524105|Behavioral|Thrive Professional Learning|Professional Learning is delivered to teachers in groups of 20-40 4 times a year over a two-year period. Professional Learning is delivered to leaders in groups of 20 - 40 three times a year over the same two-year period.
15916474|NCT03524079|Drug|Ajmaline 17-(Chloroacetate) Monohydrochloride|Ajmaline 17-(Chloroacetate) Monohydrochloride(1mg/kg in 5 minutes)
15916475|NCT03524066|Drug|Inhalation|Salbutamol(200µg), Salmeterol (50µg) and Fluticasone propionate (500µg) by inhalation
15916476|NCT03524066|Drug|Systemic|Salbutamol 8mg M/R Tablet, Propranolol 40 mg administered orally
15916477|NCT03524066|Other|Bronchoscopy|Bronchoadsorption sample, bronchial brushing, mucosal biopsy, and BAL samples during bronchoscopy
15916478|NCT03524053|Other|Exercise induced bronchoconstriction|Participants will exercise whilst inhaling dry-air, this is known to exacerbate the bronchoconstrictive response.
15916479|NCT03524053|Other|Inhibited EIB|Participants will perform the exercise-test whilst inhaling warm-humid air. This is known to inhibit the EIB response and will provide a direct comparison group for the EIB condition.
15916480|NCT03524040|Device|SEB-250|Gold microparticles (SEB-250) are massaged into 2 or 3 2x2 cm facial areas and exposed to 2 pulses from a diode laser
15916481|NCT03524027|Procedure|Posterior Vertebral Column Resection (PVCR)|Posterior Vertebral Column Resection (PVCR) Surgical Technique for Correction of Adolescent Thoracolumbar Congenital Kyphoscoliosis (CKS) Spinal Deformity
15916482|NCT03524014|Other|Only advice for diagnosis and prevention|Only advice for diagnosis and prevention
15916483|NCT03524001|Device|Compare VVi mode versus DDD bifocal stimulation through crossover randomization|All patients undergo bifocal right ventricular resynchronization therapy: right atrial lead is implanted, whereas first ventricular lead is placed in His bundle area, and the second ventricular lead in the right ventricle apex.Then the leads are connected to CRT-D generator.After the implant, all devices are programmed in VVI mode. After the first 40±10 days (first f-up) patients are 1:1 randomized to VVI mode 40 beats/minute (placebo arm) or bifocal DDD-mode 60 beats/minute.After six months (second follow-up) a clinical and instrumental assessment equal to baseline is performed. Then arms cross-over is performed (from VVI-mode to bifocal DDD-mode and vice versa). At 12 months (end of follow-up) an evaluation equal to that performed at 6 months is assessed. Echocardiographic data are unravelled to the investigator that plans stimulation mode able to determine the best clinical improved.
15916484|NCT03523988|Drug|Acetaminophen|Acetaminophen gel capsule
15916485|NCT03523988|Drug|Ibuprofen|Ibuprofen gel capsule
15916486|NCT03523975|Drug|Venetoclax|PO days 8 - 28 cycles during cycle 1 only. Starting with ramp-up dose as follows (50 mg x 7 days then 100mg x 7 days then 200 mg x 7 days then 400 mg for remainder of therapy). Will be given days 1-28 at a dose of 400 mg cycle 2-12.
15916487|NCT03523975|Drug|Lenalidomide|10 mg day 1-7 of and 15 mg day 8-14 cycle #1. 20 mg PO day day 15-21 of cycle #1 and days 1-21 cycles 2-12.
15916488|NCT03523975|Drug|Rituximab|375 mg/m2 IV day 1, 8, 15, 22 of 1st cycle then on day 1 for cycles 2, 4, 6, 8, 10, 12
15916489|NCT03523962|Drug|DuraPrep|The iodine-based treatment intervention is an antiseptic solution comprised of iodine povacrylex (0.7% free iodine) in 74% isopropyl alcohol. 3M™ DuraPrep™ [3M Health Care, St Paul, MN], will be the commercial product used.
15916490|NCT03523962|Drug|ChloraPrep|The CHG intervention is an antiseptic solution comprised of 2% CHG in 70% isopropyl alcohol. ChloraPrep® [CareFusion Inc., Leawood, KS, USA] will be the product used.
15916491|NCT03523949|Behavioral|PNE|The PNE will be delivered by a physiotherapist in a single, group-based session.
15916492|NCT03523936|Dietary Supplement|Prebiotic product|Prebiotic product used during the course of antibiotic treatment
15916493|NCT03523936|Dietary Supplement|Placebo|Placebo
15916494|NCT03523923|Behavioral|Collaborative Care|"Up to 12 phone sessions over 16 weeks from Collaborative Care Manager (CCM).
~Session 1: Establish rapport, perform structured clinical assessment explain the rationale and parameters of the intervention, provide brief education on pain and together with the participant create an overall treatment plan and detailed follow-up plan.
~Sessions 2-12 Components:
~Care Management Weekly monitoring of response to treatment using standardized measures.
~Collaborative Medical Management: Optimized management of problem areas. Medication recommendations will follow evidence-based treatment algorithms with consultation of supervisors.
~Psychosocial Treatment: Evidence based, focus on pain self-management skills/education, initially on foundational skills including: (1) pain education; (2) relaxation skills training; (3) behavioral activation and goal setting; 4) importance of physical activity and (5) motivational interviewing to promote adherence to healthcare and goals."
15916495|NCT03523910|Device|Magnetic Resonance Imaging (MRI) with exercise|MRI scan with a novel exercise device.
15916496|NCT03523897|Procedure|Robot Assisted Total Knee Replacement|A robotic-assisted surgical procedure to treat a condition in which the patient's knee joints become diseased or injured due to a loss of cartilage that acts as a protective cushion between the knee joints
15916497|NCT03523897|Procedure|Traditional Total Knee Replacement|A surgical procedure using mechanical guides to treat a condition in which the patient's knee joints become diseased or injured due to a loss of cartilage that acts as a protective cushion between the knee joints
15916498|NCT03523884|Other|Exercise Program plus Education|Rotator cuff exercises outlined in the American Academy of Orthopedic Surgeons (AAOS) guidelines on management of rotator cuff problems.
15916499|NCT03523884|Other|Educational Program (EP).|An information sheet form AAOS, outlining the anatomy, description, causes, symptoms, examination and imaging tests performed on individuals with shoulder conditions
15916500|NCT03523871|Drug|Mavyret|Patients will be on 8 weeks of Mavyret
15916502|NCT03523845|Other|Observational intervention to diagnose an early apical peri-implantitis|diagnose an early apical peri-implantitis
15916503|NCT03523832|Drug|Celecoxib and Pregabaline|Single dose versus repetition dose
15916504|NCT03523832|Other|Placebo|Placebo
15916505|NCT03523819|Drug|CS1002|Dose levels will be escalated following a modified 3+3 dose escalation scheme
15916506|NCT03523819|Drug|CS1003|Fixed dose at 200mg in combination with CS1002 on a specified dose level
15916507|NCT03523806|Behavioral|Solution-Focused Coaching in Pediatric Rehabilitation|A coaching model for children with disabilities, with a strong theoretical basis, and ability to be customized to children and families' resources, environmental settings, child age and developmental stage
15916508|NCT03523793|Behavioral|Clinical Practice Guideline Implementation|The Study team will use several methods from the implementation strategy taxonomy of the Effective Practice and Organization of Care (EPOC) classification system to improve our likelihood for successful neck and low back pain implementation consisting of: 1) educational materials, workshops and outreach visits from trainers; 2) external consultant testimonials; 3) iterative quality improvement processes (including ongoing analysis of clinician feedback to improve process); 4) routine collection of patient reported outcomes to engage discussion among clinician groups and outpatient division leaders) and 5) local organization consensus process (including feedback from key outpatient division stakeholders).
15916509|NCT03523793|Other|Standard Care|Considering the stepped wedge design with a 12-week washout phase, clinics will be providing standard physical therapy prior to receiving clinical practice guideline training.
15916510|NCT03523767|Biological|S.typhi Injection|0.5 ml of S.typhi injection
15916511|NCT03523767|Biological|Normal Saline Injection|0.5 ml of normal saline injection
15916512|NCT03523754|Drug|Isosorbide Mononitrate 40 MG to study group|Isosorbide Mononitrate will be added to Misoprostol, to determine their combined effect on cervical ripening & induction of labor in study group
15916513|NCT03523741|Drug|Clozapine|Clozapine is administered orally according to individual prescribed dosing regimens.
15916514|NCT03523728|Drug|Venglustat GZ402671|Pharmaceutical form: capsule Route of administration: oral
15916515|NCT03523728|Drug|Placebo|Pharmaceutical form: capsule Route of administration: oral
15916516|NCT03523715|Dietary Supplement|Prunes|12 oz of prunes daily
15916517|NCT03523715|Drug|Docusate Sodium|Oral docusate sodium twice daily
15916518|NCT03523702|Drug|PembroRT|Patients whose tumors are found to have high (≥ 50%) PD-L1 expression will automatically be placed in the PembroRT group. These patients will receive three intravenous treatments with pembrolizumab, followed by four weeks of daily radiotherapy, followed by up to 12 more treatments with pembrolizumab. Pembrolizumab is given as an intravenous infusion once every three weeks. This treatment course will last, in total, up to one year.
15916519|NCT03523702|Drug|ChemoRT|Patients whose tumors are found to have low (< 50%) PD-L1 expression will automatically be placed in the ChemoRT group. These patients will receive radiotherapy over a course of four to seven weeks. During radiotherapy, patients will also receive two standard chemotherapy agents (carboplatin and paclitaxel) once each week. Following completion of chemotherapy and radiotherapy, patients may receive additional treatments with chemotherapy or immunotherapy as part of routine care. These treatments are optional and are not required by this clinical trial.
15916524|NCT03523650|Drug|Propranolol Oral Tablet|A randomized group of patients with cerebral or spinal cavernous malformations, will receive a Propranolol Oral tablets, tid, for 36 months.
15916525|NCT03523650|Drug|Placebo Oral Tablet|A randomized group of patients with cerebral or spinal cavernous malformations, will receive a Placebo Oral Tablet, tid, for 36 months.
15916526|NCT03523637|Behavioral|Interoceptive Exposure|The intervention Interoceptive Exposure (IE) is an exposure to bodily sensations used in treatment of variety of problems where body sensations are experienced as threatening. This psychological technique is about focusing attention on pain, 'staying with the pain' without trying to escape it.
15916527|NCT03523611|Procedure|Lung Resection|Lung resection surgery
15916528|NCT03523598|Other|Placebo gel + Normal Toothpaste|"15 days before and during the period of bleaching sessions: Tooth paste used will be normal (Colgate).
~Teeth will be cleaned using rubber cups associated to pumice and water;
~Relative isolation with roller cotton will be done;
~Prior to each bleaching session, the patients will receive the placebo gel application on vestibular surface, for 10 minutes.
~Gingival dam will be performed using a fluid resin.
~A 35% hydrogen peroxide based bleaching agent will applied on the vestibular surface of teeth, remaining for 40 minutes."
15916529|NCT03523598|Other|Placebo Gel + Potassium Nitrate Toothpaste|"15 days before and during the period of bleaching sessions: Tooth paste used will be normal tooth paste (Colgate).
~Teeth will be cleaned using rubber cups associated to pumice and water;
~Relative isolation with roller cotton will be done;
~Prior to each bleaching session, the patients will receive the 5% Potassium Nitrate gel application on vestibular surface, for 10 minutes.
~Gingival dam will be performed using a fluid resin.
~A 35% hydrogen peroxide based bleaching agent will applied on the vestibular surface of teeth, remaining for 40 minutes."
15916530|NCT03523598|Other|Potassium Nitrate Gel + Normal Toothpaste|"15 days before and during the period of bleaching sessions: Tooth paste used will be Potassium Nitrate containing (Sensodyne).
~Teeth will be cleaned using rubber cups associated to pumice and water;
~Relative isolation with roller cotton will be done;
~Prior to each bleaching session, the patients will receive the placebo gel application on vestibular surface, for 10 minutes.
~Gingival dam will be performed using a fluid resin.
~A 35% hydrogen peroxide based bleaching agent will applied on the vestibular surface of teeth, remaining for 40 minutes."
15916531|NCT03523585|Drug|Trastuzumab deruxtecan|DS-8201a is sterile lyophilized powder reconstituted into a sterile aqueous solution (100 mg/5 mL) to be administered as intravenous (IV) dose
15916532|NCT03523585|Drug|Capecitabine|Investigator's choice Standard of Care when combined with trastuzumab or lapatinib
15916533|NCT03523585|Drug|Lapatinib|Investigator's choice Standard of Care when combined with capecitabine
15916534|NCT03523585|Drug|Trastuzumab|Investigator's choice Standard of Care when combined with capecitabine
15916535|NCT03523572|Drug|Trastuzumab deruxtecan|The investigational product is a sterile lyophilized powder, which is made into solution for intravenous administration.
15916536|NCT03523572|Drug|Nivolumab|Nivolumab is an aqueous solution formulated at 10 mg/mL to be administered at a flat dose of 360 mg IV over 30 minutes. Protocol-defined thyroid testing is required while taking nivolumab.
15916537|NCT03523559|Genetic|bladder tissue of Interstitial Cystitis and normal bladder tissue|Obtain the bladder tissue of Interstitial Cystitis and normal during the operation
15916538|NCT03523546|Other|Cancer Episode Payment Model (CEM)|Oncologists will be paid for an episode of care with the opportunity to receive a value based payment based on 6 quality metrics.
15916539|NCT03523533|Procedure|Angiocatheter|Placement of angiocatheter in internal jugular vein
15916540|NCT03523520|Drug|Methylnaltrexone Bromide 150 mg Oral Tablet|Methylnaltrexone Bromide 150 mg Oral Tablet
15916541|NCT03523520|Drug|Methylnaltrexone Bromide 12 MG/0.6 ML Subcutaneous Solution [RELISTOR]_#1|Methylnaltrexone Bromide 12 MG Subcutaneous Solution
15916542|NCT03523520|Drug|Naloxegol 25 MG Oral Tablet|Naloxegol 25 MG Oral Tablet
15916543|NCT03523507|Device|Active: rTMS|Daily sessions will consist of 3000 left-sided excitatory pulses at 10 Hz (with 4-second trains and 26-second inter-train interval) followed by 1000 right-sided inhibitory pulses at 1 Hz (in a single train). The DLPFC treatment target will be determined using individualized resting-state network mapping.
15916544|NCT03523507|Device|Sham: rTMS|Daily sessions will consist of the same total number of sham pulses, designed to have similar sound and tactile sensation, without producing active stimulation.
15916547|NCT03523455|Dietary Supplement|Iron Aid IPS (Iron Protein Succinylate)|Taken orally in capsule form
15916548|NCT03523455|Other|Sugar Pill|Taken orally in capsule form
15916549|NCT03523442|Drug|Apalutamide|The participants will receive apalutamide 240 mg once daily orally.
15916550|NCT03523429|Drug|blinatumomab|Blinatumomab is a bispecific monoclonal antibody designed to bind specifically to CD19, expressed on the surface of B-cells, and to CD3, expressed on the surface of T-cells. It activates endogenous T-cells by connecting the CD3 on the T-cell receptor complex (TCR) with the CD19 on the B-cells. The anti-tumour activity of blinatumomab does not depend on whether the T-cells carry a specific TCR or peptide antigens present in cancer cells, but it is polyclonal and independent of HLA on the target cells
15916551|NCT03523416|Device|Transcatheter Atrial Shunt System|Transcatheter treatment of symptomatic left heart failure patients
15916552|NCT03523403|Other|Apples|3 whole Ontario-grown Gala apples
15916553|NCT03523390|Drug|Avelumab|Subjects will receive an intravenous infusion of avelumab once every 2 weeks (q2w) or every week for the first 12 weeks and then q2w from Week 13 until progressive disease.
15916555|NCT03523364|Device|dental restorations|partial or complete ceramic restorations bonded to dental tissues after WAB and total etching or after total etching
15916619|NCT03522818|Behavioral|Manual Trigger|Will use the alarm as provided by the manufacture but parent has to manual trigger the alarm 1-2 hours after the child falls asleep.
15916620|NCT03522818|Behavioral|Normal|Will use the alarm as provided by the manufacture.
15916556|NCT03523351|Radiation|Radiation Therapy|Radiation therapy will be delivered according to department standards. For this protocol, total dose and dose fractionation may be delivered at the discretion of the treating radiation oncologist according to department standards. All techniques including conventional, 3D-CRT, or IMRT technique may be used. Image guidance at the time of treatment delivery to verify patient positioning may be chosen at the discretion of the treating radiation oncologist according to department standards.
15916557|NCT03523351|Drug|Systemic Therapy|Standard of care systemic therapy, including chemotherapeutics, targeted therapies, immunomodulatory agents, and hormonal therapies will be delivered at the discretion of the treating medical oncologist. Patients may receive systemic therapy concurrently and there are no restrictions on initiation of systemic agents after radiotherapy including immunotherapy and hormonal therapy, the timing of which will be determined by a consensus between the treating medical and radiation oncologists.
15916558|NCT03523338|Drug|Apalutamide|Participants will receive apalutamide 240 mg orally once daily.
15916559|NCT03523338|Drug|ADT (Standard of Care)|Participants who did not undergo surgical castration, should receive and remain on a stable regimen of ADT according to local standard of care.
15916560|NCT03523325|Other|Exercise treatment|Treatment protocol is an exercise program consisting of four different phases (Silbernagel protocol). The progression consists of increasing number of repetitions, resistance, speed and range of motion of the exercises. A pain-monitoring model is used to adjust the exercise loads and progression through the four phases.
15916563|NCT03523299|Procedure|Cryoablation|Cryoablation is a non-surgical, minimally invasive freezing procedure used to destroy tumors. In the breast, cryoablation is performed under ultrasound guidance. Due to the analgesic properties of freezing, no IV sedation or anesthesia is required. After administration of local anesthetic, the physician makes a 2-3 mm incision and inserts needle-like cryoprobes into the tumor, commencing a number of freeze-thaw cycles. Then the probe is removed, pressure is applied to the area, and a bandage is placed. The patient leaves the office without stitches and minimal, if any, pain. Any residual pain after the procedure is routinely treated with over the counter analgesics such as acetaminophen.
15916564|NCT03523286|Other|RAPID-VT Software guided ablation|Catheter ablation will target VT exit sites at scar margin as determined by the RAPID-VT software
15916565|NCT03523273|Drug|Liraglutide|Initiate at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6mg/day in weekly intervals to a dose of 3.0 mg/day is achieved (~4 weeks). Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
15916566|NCT03523273|Drug|Placebo|Placebo administration will match the study drug.
15916567|NCT03523260|Device|Tunneled dialysis catheter placement.|Placement of high-flow tunneled catheter for hemodialysis
15916568|NCT03523247|Behavioral|whole food, plant based diet|whole food, plant based diet featuring vegetables, fruits, legumes, whole grains, seeds, and nuts
15916569|NCT03523234|Drug|neoadjuvant chemotherapy|etoposide with cisplatin/carboplatin, undergoing in prior to the surgery
15916570|NCT03523234|Procedure|radical surgery for stage II and IIIA small cell lung cancer (SCLC)|Lobectomy/total lung resection plus mediastinal lymph node dissection.
15916571|NCT03523234|Procedure|prophylactic cranial irradiation|prophylactic cranial irradiation (PCI) undergoing with adjuvant chemotherapy simultaneously
15916572|NCT03523234|Drug|Chemotherapy|etoposide with cisplatin/carboplatin
15916573|NCT03523221|Drug|Dexamethasone Oral|use of one dose of Dexamethasone orally.or placebo in addition to regular treatment of anaphylaxis
15916574|NCT03523195|Behavioral|Exercise Intervention|Complete exercise program
15916575|NCT03523195|Other|Informational Intervention|Receive written information on healthy exercise and diet recommendations
15916576|NCT03523195|Other|Laboratory Biomarker Analysis|Blood tests
15916577|NCT03523195|Device|Monitoring Device|Wear Fitbit
15916578|NCT03523195|Other|Questionnaire Administration|Ancillary studies
15916579|NCT03523195|Other|Physical Performance Testing|Performance of physical tests
15916580|NCT03523182|Dietary Supplement|Spirulina|"Arthrospira platensis, also known as spirulina, is a blue-green micro-algae indigenous to Africa.
~Spirulina group (n=251) receive a soya-maize-based porridge with the addition of spirulina.
~We used 10 g per day of spirulina powder with a mealie meal and soya flour porridge blend."
15916581|NCT03523182|Dietary Supplement|Control|Children receive a soya-maize-based porridge for 12 months. We use a mealie meal and soya flour porridge blend.
15916582|NCT03523156|Drug|Azithromycin mass treatment|Standard of care annual community-wide mass drug administration (MDA) will be provided at the normally scheduled time.
15916583|NCT03523156|Drug|Azithromycin targeted treatment|Two rounds of treatment targeted to all children aged 2 to 9 years old. The first targeted round will be 1-2 weeks after the community-wide MDA and the second round will occur another 1-2 weeks later.
15916584|NCT03523143|Other|early screening and intervention|The early screening group will be screened by a 75g 2-hour oral glucose tolerance test (OGTT) at 18-20 weeks of gestational age (GA). Gestational diabetes mellitus (GDM) is diagnosed according to the IADPSG criteria. Subjects diagnosed with GDM will receive nutrition counseling, and lifestyle intervention. Pharmacologic therapies exclusively with human insulin or insulin analogues will be given when the target of glycemic control is not achieved within 4 weeks. The process of screening and intervention in the early screening group is all the same with that in the standard screening group. The only difference between two groups is the time of screening and intervention (18-20 weeks vs. 24-28 weeks of GA).
15916616|NCT03522844|Drug|Escitalopram|Escitalopram is an antidepressant, widely used to treat anxiety disorders. During the 8 weeks of randomized treatment with escitalopram, subjects will be seen regularly by a study physician. The pill medication will be initiated at 10 mg/day; at week 2, dosage will be increased to 20 mg/day if well tolerated (or delayed if not). Side effects will be assessed at each visit and recorded.
15916617|NCT03522831|Drug|Salbutamol|Administration of 400 μg meter-dose inhaler of salbutamol performed using large-volume spacer
15916585|NCT03523143|Other|standard screening and intervention|The standard screening group will be screened by a 75g 2-hour oral glucose tolerance test (OGTT) at 24-28 weeks of gestational age (GA). Gestational diabetes mellitus (GDM) is diagnosed according to the International Association of Diabetes and Pregnancy Study Group (IADPSG) criteria, ie. if one of the plasma glucose levels at fasting, 1-hour, and 2-hour during OGTT is above 92 mg/dL, 180 mg/dL, and 153 mg/dL, respectively. Subjects diagnosed with GDM will receive nutrition counseling, and lifestyle intervention. Pharmacologic therapies exclusively with human insulin or insulin analogues will be given when the target of glycemic control is not achieved within 4 weeks.
15916586|NCT03523130|Diagnostic Test|Imaging|Macrophage-specific inflammation
15916587|NCT03523117|Drug|Ferric carboxymaltose|Intravenous iron
15916588|NCT03523117|Drug|Ferrous Sulfate|oral iron therapy
15916589|NCT03523091|Drug|OnabotulinumtoxinA 100Unit Injection|Initial treatment with the option of repeat injections every 3 months
15916590|NCT03523078|Procedure|Breast reconstructive surgery|All sorts of breast reconstructive surgery are allowed in this study in terms of timing, autologous/prosthetic and so forth.
15916591|NCT03523039|Device|CytoSorb® Hemoadsorption|The therapy is initiated within 6 hours from randomization and maintained for a minimum of 12 consecutive hours to a maximum of 24 consecutive hours.
15916592|NCT03523026|Device|Neuromuscular Electrical Stimulation|Neuromuscular Electrical Stimulation(NMES) to rectus abdominis will be applied using 4 carbon silicon electrode. In the first sessions, patients ECG will be checked. Patients will be in semi-fowler position (30º),with their lower limbs to be in extension and upper limbs at their sides. The NMES frequency will be at 30 Hertz and the application time will be 30 minutes. Treatment will be programmed for 3 days per week. The patients will coordinate their breath (inspiration) with the contraction which will be generated by the electrical current. The program will continue for 6 weeks.
15916593|NCT03523026|Other|Inspirator Muscle Training|Inspirator Muscle Training(IMT) will be applied 7 days per week, twice a day for 15 minutes. The program will continue for 6 weeks duration under weekly control of the investigator.Training intensity will set at 30% of the maximum inspiratory pressure.
15916594|NCT03523026|Other|Peripheral Muscle Training|Peripheral Muscle Training will be applied by elastic band and Proprioceptive Neuromuscular Facilitation 3 times per week.The program will continue for 6 weeks.
15916595|NCT03523013|Device|CPAP|CPAP treatment with different pressure for OSA patients
15916596|NCT03523000|Other|Continuous intrathecal prognostic infusion test|The patient is infused with solution through the percutaneous intrathecal catheter at a rate of 0.5-1.0 ml/hr for approximately 14-18 hours
15916597|NCT03522987|Drug|Escitalopram 10mg|Participants will be given escitalopram 10mg by mouth daily and will be followed up at 2, 4, 6, 8, and 10 weeks. Medication will be adjusted if side effects occur. If unable to tolerate escitalopram, then venlafaxine XR (Effexor XR) 37.5mg will be substituted.
15916598|NCT03522974|Dietary Supplement|Strawberry powder|Freeze dried strawberry powder
15916599|NCT03522974|Dietary Supplement|Placebo powder|40 g/d placebo powder matched for taste and appearance
15916600|NCT03522961|Drug|Nitrofurantoin Prophylaxis/Placebo|Drug: Nitrofurantoin Drug: Placebo
15916601|NCT03522961|Drug|Cranberry capsules|Drug: TheraCran® One Cranberry capsules
15916602|NCT03522948|Behavioral|Brief intervention with text messaging to reduce sexual risk and heavy drinking among MSM|Combines a brief in-person motivational intervention with personalized cognitive counseling elements and 4 weeks of personalized text messaging to support goals related to sexual risk behavior and alcohol use
15916603|NCT03522935|Drug|Elafin|Elafin subcutaneous.
15916604|NCT03522935|Drug|Placebo|Placebo subcutaneous.
15916605|NCT03522922|Device|Dermaroller|The derma roller used (dermaroller MF8, MT dermaroller Beverly Hills, California USA) is a plastic device with a 12-cm handle that holds a drum-shaped cylinder at the end, similar to a small paint roller, 2 cm in diameter and 2 cm in width. The surface of the cylinder holds 192 titanium needles in eight rows. Each 0.25 mm in diameter and 1.5 mm length sterilized by UV/ Gamma rays.
15916606|NCT03522922|Drug|Topical Vitamin C|The used vitamin C product was in the form of 17% concentration of L- Ascorbic Acid serum that was encapsulated in gelatinous capsules each contain 1 mg of the serum. The patient instructed to open one capsule and apply its serum content on the treatment area daily at night. This capsule form for topical application help to insure stability of the product and also insure use of equal dose in each application
15916607|NCT03522909|Other|Seen in clinic|"We will be doing a retrospective chart review of patients seen in the Center for Peripartum Optimization to look for:
~Primary outcome variable.
~- Hospital length of stay
~Secondary outcome variables.
~Number of admissions from outside hospitals
~Adverse outcomes
~Intensive Care Unit admissions
~Opioid use
~NICU admissions
~Patient satisfaction
~Cost of inpatient admission
~Cost of outpatient care
~Hospital readmissions rate"
15916608|NCT03522896|Other|control|balancing sugars and organic acids
15916609|NCT03522896|Other|test meal 1|orange juice plus hesperidin low dose
15916610|NCT03522896|Other|test meal 2|orange juice plus hesperidin higher dose
15916611|NCT03522896|Other|test meal 3|diluted orange juice plus hesperidin low dose
15916612|NCT03522883|Dietary Supplement|carbohydrate intake prior to exercise|Participants will be submitted to carbohydrate supplementation prior to exercise
15916613|NCT03522870|Device|Flash glucose monitoring system|Using flash glucose monitoring system continuously on Week 2-14 and Week 14-26
15916614|NCT03522870|Device|SMBG|Performing SMBG at least three times/day on Week 2-14 and Week 14-26
15916615|NCT03522844|Other|Mindfulness-Based Stress Reduction|Participants randomized to the MBSR intervention will consist of an 8-week Mindfulness-Based Stress Reduction (MBSR) program, taught and facilitated by a trained instructor. The classes instruct participants in the theory and practice of several forms of mindfulness meditation: a body scan, breathing awareness, and mindfulness stretching exercises designed to bring awareness of the body and current experience of movement. The intervention will include a weekly class for 8 weeks and classes will be 2.5 hours in duration. The intervention will also include a 1-day (7 hours) retreat on a weekend at the end of the program. Participants will also be asked to engage in 45 minutes of practice at home on a daily basis, as well as informal practice assignments that instruct participants to bring mindfulness to current daily activities.
15916618|NCT03522831|Drug|Placebo|Administration of 400 μg meter-dose inhaler of placebo performed using large-volume spacer
15916621|NCT03522805|Device|High-intensity non-invasive ventilation|Single night of high-intensity non-invasive ventilation
15916622|NCT03522792|Other|Neurotensin|Intravenous infusion of neurotensin
15916623|NCT03522792|Other|Saline|Intravenous infusion of saline
15916624|NCT03522792|Other|Ad libitum meal|Participants will be served a large meal serving. They will be instructed to eat until they do not feel hungry anymore.
15916625|NCT03522792|Other|Liquid meal|A standardized mixed liquid meal will be ingested to stimulate endogenous peptide hormone release
15916626|NCT03522779|Dietary Supplement|Tart cherry Juice|Tart cherry juice will be used to compare antioxidant and oxidative stress levels in human plasma following a high fat meal.
15916627|NCT03522779|Other|High-fat meal|A high fat meal will be given to elicit postprandial oxidative stress.
15916628|NCT03522779|Other|Exercise|The exercise will consist of 30 minutes of treadmill running at 70% of each participants' calculated heart rate reserve.
15916629|NCT03522766|Other|urine sample|The subjects are asked to give a maximum of 15 urine samples during the study
15916630|NCT03522753|Device|Metal skin staples|Routine closure methods/material for surgical wounds
15916631|NCT03522753|Device|Nylon sutures|Routine closure methods/material for surgical wounds
15916632|NCT03522740|Other|Decision Aid for Renal Therapy|DART is a web-based decision aid that informs older adults with advanced kidney disease of kidney disease treatment options and prompts them to consider their preferences and raise questions to discuss with their kidney disease providers.
15916633|NCT03522727|Behavioral|Single self-incentivising implementation intention|Participants are asked to form a single self-incentivising implementation intention (if-then plans)
15916634|NCT03522727|Behavioral|Multiple self-incentivising implementation intentions|Participants are asked to form multiple self-incentivising implementation intentions (if-then plans)
15916635|NCT03522727|Behavioral|Self-generated self-incentivising implementation intentions|Participants are asked to form a self-incentivising implementation intention (if-then plans) without a drop-down menu
15916636|NCT03522714|Device|Fluid Immersion Simulation System|Dolphin Fluid Immersion Simulation® System Mattress will be used
15916637|NCT03522714|Device|Air Fluidized Bed System|Air Fluidized Bed (Clinitron) will be used.
15916638|NCT03522701|Behavioral|CBTI|Refer to the arm description
15916639|NCT03522688|Drug|Dexmedetomidine|The treatment group was given dexmedetomidine by constant intravenous (IV) infusion at a rate of 0.4mcg/kg/hour.
15916640|NCT03522675|Device|NeoMatriX Wound MatriX Collagen Dressing|Collagen wound dressing
15916641|NCT03522662|Drug|GSK1070806|Single 10mg/kg infusion on Day 0
15916642|NCT03522649|Drug|Napabucasin|Napabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 8~12 hours.
15916643|NCT03522649|Drug|Fluorouracil|Fluorouracil 400 mg/m^2 bolus will be administered intravenously immediately following irinotecan/leucovorin infusion, followed by Fluorouracil 1200 mg/m^2/day (total 2400 mg/m^2) continuous infusion.
15916644|NCT03522649|Drug|Leucovorin|Irinotecan 180 mg/m^2 followed by or concurrent with leucovorin 400 mg/m^2 will be administered intravenously, over approximately 90 minutes and 2 hours, respectively.
15916645|NCT03522649|Drug|Irinotecan|Irinotecan 180 mg/m^2 followed by or concurrent with leucovorin 400 mg/m^2 will be administered intravenously, over approximately 90 minutes and 2 hours, respectively.
15916646|NCT03522623|Other|Non-interventional study|Non-interventional study
15916647|NCT03522610|Behavioral|ADAPT|Two hour, once a week in-person parenting program for 14 weeks plus use web-enhanced supplemental ADAPT materials
15916648|NCT03522584|Biological|Durvalumab|Given IV
15916649|NCT03522584|Other|Laboratory Biomarker Analysis|Correlative studies
15916650|NCT03522584|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15916651|NCT03522584|Biological|Tremelimumab|Given IV
15916652|NCT03522584|Procedure|Hypofractionated Image-Guided Radiation Therapy|Undergo HIGRT
15916653|NCT03522571|Behavioral|Experimental gingivitis|Individual cast models were prepared on alginate impressions. A 2-mm thick film of technical wax was set on the supra gingival area at buccal and proximal surfaces of study teeth on test quadrant. The stent were delivered at day 0. Subjects were instructed to wear the stent prior to the oral hygiene session throughout the experimental gingivitis period to prevent plaque removal during brushing of the remaining dentition. On Day 42 (T6): After recording of clinical parameters, oral hygiene instruction and an additional session of supragingival scaling, as needed, and polishing were given.
15916654|NCT03522558|Behavioral|Standardized Medical Nutrition Therapy|Standardized Medical Nutrition Therapy will include nutrition assessment provided by a registered dietitian (RD) at initial clinic visit or first Well Child Check (WCC) and regularly scheduled nutrition follow-up at each WCC visit thereafter.
15916655|NCT03522558|Behavioral|Usual Care|At the primary care provider's discretion, a nutrition consult can be requested for the RD to perform nutrition assessment or discuss the patient's plan without full nutrition assessment, as is current practice. Currently in the Neonatal High-Risk Clinic (NHRC) and High Risk Children's Clinic (HRCC) at UTHealth, providers consult the RD as deemed appropriate with no established criteria for when to include the RD in patient care. Usual care will not be modified by the study protocol.
15916656|NCT03522545|Biological|Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs)|Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs) isolated from hematogenous bone marrow
15916657|NCT03522545|Biological|Placebo|Placebo for Allogeneic Bone Marrow Derived Multipotent Mesenchymal Stromal Cells (MSCs)
15916658|NCT03522532|Procedure|Amalgam placement|Before the Amg was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.
15916659|NCT03522532|Procedure|Tetric EvoCeram placement|Before the TEC was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.
15916660|NCT03522532|Procedure|Beautifil placement|Before the BF was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.
15916661|NCT03522532|Procedure|Zinc phosphate cement placement|Before the ZPhC was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.
15916662|NCT03522532|Procedure|Zinc polycarboxylate cement placement|Before the ZPoC was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.
15947892|NCT03280316|Procedure|botulinum toxin A injection|BOTOX
15916663|NCT03522532|Procedure|Glass ionomer cement placement|Before the GIC was sealed GCF was taken, and then taken again on the 7th and 30th days after the applied treatment.
15916664|NCT03522519|Behavioral|Real world performance of physical activity and arm use|Patients will be assessed by using movement sensors and standard clinical assessments
15916665|NCT03522506|Drug|TAK-925|TAK-925 intravenous infusion.
15916666|NCT03522506|Drug|TAK-925 Placebo|TAK-925 placebo-matching given as saline intravenous infusion.
15916667|NCT03522506|Drug|Modafinil|Modafinil tablets.
15916668|NCT03522506|Drug|Modafinil Placebo|Modafinil placebo-matching tablet.
15916669|NCT03522493|Device|"Yaalom Katom"|Full face Gas mask
15916670|NCT03522480|Device|Jamboxx Respiratory Therapy Device|The Jamboxx Respiratory Therapy Device is a novel device that uses interactive gaming to encourage patient compliance with their prescribed respiratory therapy routines. The device consists of a computer game controller with mouthpiece, and breath flow sensor that connects to a tablet. With the Jamboxx respiratory therapy device, users can choose from a suite of breath controlled respiratory therapy games to guide them through their routines while receiving real-time feedback, and long-term progress tracking.
15916671|NCT03522480|Other|Autogenic Draining Training|A respiratory therapist will teach children how to conduct the autogenic draining technique (a series of exhalations and inhalations) by demonstrating the technique to them, and having them practice in their office. Children will also receive an informational packet and short video about the technique for reference
15916672|NCT03522467|Drug|MRCP001|MRCP001 is a formulated whole-plant cannabis oil extract, that may help manage poorly controlled chronic pain.
15916673|NCT03522454|Dietary Supplement|Protein-rich oral nutritional supplement|Ready-to-drink beverage containing 20 g protein and 1.5 g hydroxymethylbutyrate (HMB) per serving, consumed twice daily.
15916674|NCT03522454|Behavioral|Home-based supervised exercise program|WEBB (Weight-bearing Exercise for Better Balance) program combining walking and weight-bearing exercises to build strength and balance, administered by a trained therapist at the participant's home.
15916675|NCT03522441|Drug|Clindamycin 1% Gel|Topical gel
15916676|NCT03522441|Drug|Placebo|Topical Placebo gel
15916677|NCT03522428|Dietary Supplement|vitamin b12|Vitamin B12 has been added to the experimental group of pregnant women, at a dose of 5 μg / 100 days
15916678|NCT03522415|Drug|HLX01|HLX01,Recombinant Human-mouse Chimeric Anti-CD20 Monoclonal Antibody Injection is recombinant human-mouse chimeric anti-cd20 CD20 monoclonal antibody.
15916679|NCT03522415|Drug|Methotrexate（MTX）|Methotrexate is a slow-acting antirheumatic drug.
15916680|NCT03522402|Drug|Sevoflurane|38 patients American Society of Anesthesiologists (ASA) class I or II aged 2-8 years undergoing tonsillectomy surgery were randomized to either the patient's head in the neutral position or 30 degree rotated lateral position. The end-tidal (ET) sevoflurane concentration used for each patient was determined using the Dixon's up-and-down method. The ratio of the end-tidal to predetermined end-tidal concentrations was maintained at 0.95-1.0 for at least 10 minutes to establish equilibration before device insertion was attempted. The first patient received a 5.0% sevoflurane concentration and the step size of increase/decrease was 0.5%.
15916681|NCT03522389|Procedure|AOT with gait training|"AOT with gait training composes of program of watching video in different views of normal walk for 5 min.
~After that, participants will receive gait training program. The program consists of warm-up, gait training, cool-down, and stretching. Gait training is classified into the different levels of difficulty in each week. The 1st week will be walking over the markers followed by 100 steps/min of metronome. The second week will be walking over the markers followed by 120 step/min of metronome. The 3rd week will be walking followed by 120 step/min of metronome but not has the markers. The 4th week will imagine and imitate the walking in the 2nd week but not has the markers and metronome."
15916682|NCT03522389|Procedure|Gait training|"To control a total time of training, the gait training group will watch video of Vincent van Gogh's painting for 5 min. After that, participants will training the gait as protocol of experimental group.
~The program consists of warm-up, gait training, cool-down, and stretching. Gait training is classified into the different levels of difficulty in each week. The 1st week will be walking over the markers followed by 100 steps/min of metronome. The second week will be walking over the markers followed by 120 step/min of metronome. The 3rd week will be walking followed by 120 step/min of metronome but not has the markers. The 4th week will imagine and imitate the walking in the 2nd week but not has the markers and metronome."
15916683|NCT03522389|Other|Education|There will be no intervention exercise program provide for the control group. They will receive education about dementia such as definition, etiology, sign and symptom, and caring.
15916684|NCT03522376|Other|Loaded inspiratory muscle test|Loaded inspiratory muscle tests will be set at 30% and 50% of maximal inspiratory pressure. The orders of the two loaded test conditions will be conducted in random order with at least 24 hours separation. This is an observational study. Subjects will perform only 15 breaths with each loaded test condition to exam the performance of their inspiratory muscles. Loaded inspiratory muscle test is not for training.
15916685|NCT03522363|Other|Streptococcus dentisani CECT7746|Treatment will be applied topically as an adhesive gel with a dental splint
15916686|NCT03522350|Device|EmbryoScope|Standard of care arm
15916687|NCT03522350|Device|EmbryoScope+|Experimental arm
15916688|NCT03522337|Other|Visual pedagogy (social stories)|Oral health instruction, tooth-brushing training (toothbrushes and fluoridated toothpastes provided)
15916689|NCT03522337|Other|Conventional leaflets|Oral health instruction, tooth-brushing training (toothbrushes and fluoridated toothpastes provided)
15916690|NCT03522324|Drug|Cannabis Edible|Self-Directed Use (ad-libitum)
15916691|NCT03522311|Procedure|Vitrectomy|
15916692|NCT03522298|Drug|Paxalisib (GDC-0084)|Patients will be dosed orally with paxalisib (GDC-0084) capsules (15-mg each) at the dose and schedule to which they are assigned.
15916693|NCT03522285|Other|investigation: erythrocyte sedimentation rate|investigations will be done to detect presence of infection and x-ray also for detection of infection or loosing of hip components
15916694|NCT03522272|Device|Ultrasonic cleaning|Ultrasonic cleaning (frequency 42kHz) (for 7 minutes 30 seconds) with cetylpyridinium chloride
15916695|NCT03522272|Device|Ultrasonic cleaning|Ultrasonic cleaning (frequency 42kHz) (for 7 minutes 30 seconds) with water
15916696|NCT03522272|Other|Conventional denture hygiene|Mechanical cleaning of denture with a soft toothbrush and liquid detergent
15916697|NCT03522259|Drug|Rivaroxaban 10 MG Oral Tablet [Xarelto]|Rivaroxaban 10mg per os is started on the first postoperative day. Patients receive Rivaroxaban 10mg QD for 7days (short arm) or 28 days (long arm)
15916698|NCT03522246|Drug|Rucaparib|Oral rucaparib will be administered twice daily
15916699|NCT03522246|Drug|Nivolumab|IV nivolumab will be administered once every 4 weeks
15916700|NCT03522246|Drug|Placebo Oral Tablet|Placebo tablets will be administered twice daily
15916701|NCT03522246|Drug|Placebo IV Infusion|IV placebo will be administered once every 4 weeks
15916702|NCT03522220|Behavioral|3D navigation video game intervention|Participants intensively train with a video game (Super Mario DS)
15916703|NCT03522220|Behavioral|video game intervention without 3D navigation|Participants train with a video game (Super Mario Bros)
15916704|NCT03522220|Behavioral|No 3D navigation|Participants read on a kindle device (control group)
15916705|NCT03522207|Diagnostic Test|polysomnography|BASELINE PSG Patient has to sleep over at the hospital (sleep lab). The technician will place several sensors on your scalp, temples, chest and legs to record all the data needed for your evaluation. You will be monitored throughout the duration of the test (approximately 6 hours). Brain waves, eye movements, chin muscle tone, breathing patterns, snoring, heart rate, blood pressure, blood oxygen level, body position and muscle activity will be recorded.
15916706|NCT03522207|Drug|Trazodone|100 mg trazodone or placebo given once 30 minutes prior to 2nd PSG
15916707|NCT03522207|Drug|Placebos|placebo per os 30 minutes prior to 2nd PSG
15916708|NCT03522207|Diagnostic Test|polysomnography|2nd psg, done 1 week after baseline. Patient has to sleep over at the hospital (sleep lab). The technician will place several sensors on your scalp, temples, chest and legs to record all the data needed for your evaluation. You will be monitored throughout the duration of the test (approximately 6 hours). Brain waves, eye movements, chin muscle tone, breathing patterns, snoring, heart rate, blood pressure, blood oxygen level, body position and muscle activity will be recorded.
15916709|NCT03522207|Drug|Trazodone|100 mg trazodone per os 30 minutes prior to 3rd PSG
15916710|NCT03522207|Drug|placebos|100 mg placebo per os 30 minutes prior to 3rd PSG
15916711|NCT03522207|Diagnostic Test|polysomnography|3rd PSG, done 2 weeks after baseline. Patient has to sleep over at the hospital (sleep lab). The technician will place several sensors on your scalp, temples, chest and legs to record all the data needed for your evaluation. You will be monitored throughout the duration of the test (approximately 6 hours). Brain waves, eye movements, chin muscle tone, breathing patterns, snoring, heart rate, blood pressure, blood oxygen level, body position and muscle activity will be recorded.
15916712|NCT03522194|Drug|Sevoflurane|Anesthesia maintenance with Sevoflurane
15916713|NCT03522194|Drug|Propofol|Anesthesia maintenance with Propofol
15916714|NCT03522181|Other|saline|saline
15916715|NCT03522181|Other|Insulin|
15916716|NCT03522168|Drug|Risperidone|Medications prescribed as standard of care for Schizophrenia, Bipolar mania/acute treatment of manic and mixed episodes associated with Bipolar I disorder, Tourette's disorder, persistent (chronic) motor or vocal tic disorder and Irritability associated with autistic disorder
15916717|NCT03522168|Drug|Aripiprazole|Medications prescribed as standard of care for Schizophrenia, Bipolar mania/acute treatment of manic and mixed episodes associated with Bipolar I disorder, Tourette's disorder, persistent (chronic) motor or vocal tic disorder and Irritability associated with autistic disorder
15916718|NCT03522155|Behavioral|Patient-centered communication of life expectancy|The intervention arm will test if patient-specific LE estimates via a targeted, patient-centered communication approach paired with LE-specific conjoint analysis data improves decisional conflict, quality of LE discussion, and reduces rates of overtreatment of Genitourinary malignancies.
15916719|NCT03522142|Drug|INCB081776|INCB081776 administered once daily orally with water after a fast of at least 2 hours before and at least 1 hour after the dose.
15916720|NCT03522142|Drug|INCMGA00012|INCMGA0012 administered intravenously according to the label as 500 mg every 4 weeks
15916721|NCT03522129|Drug|CT1812|Active Study Drug
15916722|NCT03522129|Drug|Placebo|Non-active study drug
15916723|NCT03522116|Other|No intervention|No intervention
15916724|NCT03522090|Diagnostic Test|lower neck CT|Computerised tomography of the lower neck done as part of initial CT thorax and lower abdomen
15916725|NCT03522077|Device|RadAR EasyCLik plus ®-STF hemostatic pad|Chitosan-based, non-woven pad with a unique, proprietary fiber structure that when hydrated with tissue fluids forms a gel-like synthetic clot in conjunction with the RadAR EasyCLik compression device
15916726|NCT03522077|Device|TR BAND® Compression device plus ®-STF hemostatic pad|Chitosan-based, non-woven pad with a unique, proprietary fiber structure that when hydrated with tissue fluids forms a gel-like synthetic clot in conjunction with the TR BAND® compression device
15916727|NCT03522077|Device|SoftSeal®-STF hemostatic pad|Chitosan-based, non-woven pad with a unique, proprietary fiber structure that when hydrated with tissue fluids forms a gel-like synthetic clot
15916728|NCT03522077|Device|VascBand™ Hemostat|The VascBand™ Hemostat is an FDA-approved compression device designed to assist hemostasis of arterial, venous and hemodialysis percutaneous access sites.
15916731|NCT03522051|Other|calcium silicate based material,|Its a dental pulp capping material which is biocompatable and induces hard tissue barrier formation
15916732|NCT03522038|Procedure|percutaneous coronary intervention|PCI was performed using standard techniques. Antiplatelet and antithrombotic agents were prescribed according to current PCI guidelines. A procedure was considered successful when achieving TIMI flow grade 3 with <30% angiographic residual stenosis in the CTO vessel. All patients received drug-eluting stents and were discharged on dual antiplatelet therapy with duration of at least on year.
15917005|NCT03519971|Drug|Pemetrexed/ Carboplatin|Pemetrexed / Carboplatin , as per standard of care
15916733|NCT03522025|Device|Unicompartmental Knee Arthroplasty (UKA)|Unicompartmental Knee Arthroplasty (UKA) is a less invasive treatment option compared to Total Knee Arthroplasty (TKA) for patients with primary anteromedial knee osteoarthritis.
15916734|NCT03522012|Drug|Tocilizumab|Tocilizumab is a recombinant human monoclonal antibody of the immunoglobulin G1 subclass, directed against the IL-6 ligand specific receptor. By preventing the binding of IL-6 to its receptor, tocilizumab inhibits the biological activity of IL-6. Tocilizumab was approved by the US Food and Drug Administration (4 mg/kg with an increase to 8 mg/kg based upon clinical response) for the treatment of adult patients with moderate to severe active rheumatoid arthritis, who have had inadequate response to one or more tissue necrotizing factor (TNF) antagonist therapies. Tocilizumab is currently approved in 95 countries for the treatment of adult onset moderate to severe rheumatoid arthritis.
15916735|NCT03521999|Behavioral|AboutFace|AboutFace is an online peer-to-peer digital storytelling resource for Veterans with PTSD. Veterans will have access to AboutFace while they are enrolled in PTSD specialty care through the Charleston PCT.
15916736|NCT03521999|Other|Enhanced Usual Care (eUC)|Enhanced Usual Care (eUC) includes access to a PTSD educational brochure. Veterans will have access to the brochure information while they are enrolled in PTSD specialty care through the Charleston PCT.
15916737|NCT03521986|Procedure|Subxiphoid uniportal VATS|Patients were placed in a supine position, and the operating table was manipulated as needed to elevate the appropriate side of the body for surgery. The surgical procedures followed principles of pulmonary resections
15916738|NCT03521986|Procedure|Intercostal uniportal VATS|The surgical procedures followed principles of pulmonary resections
15916739|NCT03521973|Biological|PfSPZ Vaccine|Radiation-attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ Vaccine)
15916740|NCT03521973|Other|Normal Saline|0.9% Sodium chloride
15916741|NCT03521960|Drug|Buspirone oral capsule|15 milligrams, three times daily
15916742|NCT03521960|Drug|Placebo oral capsule|0 milligrams (placebo), three times daily
15916743|NCT03521947|Diagnostic Test|Complete blood picture|Iaboratory investigation
15916744|NCT03521934|Drug|Sotagliflozin (SAR439954)|"Pharmaceutical form: tablet
~Route of administration: oral"
15916745|NCT03521934|Drug|Placebo|"Pharmaceutical form: tablet
~Route of administration: oral"
15916746|NCT03521921|Device|Mitraclip|Edge-to edge mitral valve repair
15916747|NCT03521908|Other|Non-Interventional|Non-Interventional
15916748|NCT03521908|Other|Non-Interventional|Non-Interventional
15916749|NCT03521895|Drug|Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)|Patients observed with regular and irregular treatment course
15916750|NCT03521869|Device|Compression bandage|Compression bandage placed after total knee replacement
15916751|NCT03521869|Device|Gauze dressing|standard of care gauze dressing placed after total knee replacement
15916752|NCT03521856|Behavioral|shoulder exercise|Exercises performed 3 times a week for 12 weeks
15916753|NCT03521856|Behavioral|education|
15916754|NCT03521843|Device|balloon dilation only|The balloon dilation only will be used to treat the femoropopliteal in-stent restenosis.
15916755|NCT03521843|Device|balloon dilation+local drug delivery|The balloon dilation and local drug delivery will be used to treat the femoropopliteal in-stent restenosis.
15916756|NCT03521830|Drug|Nivolumab|480mg IV every 4 weeks
15916757|NCT03521830|Drug|Ipilimumab|1mg/kg IV every 4 weeks for 4 doses
15916758|NCT03521830|Drug|Relatlimab|960 mg IV q4wks
15916759|NCT03521817|Other|Alcohol|"The ethanol group will consume a 30% energy restriction diet that will also include ~2.5 standard drinks, or 35 grams of ethanol, administered as 80-proof distilled spirits (e.g. 80 proof gin, rum, vodka, whiskey, or tequila). In the United States, one standard drink contains roughly 14 grams of pure alcohol."
15916760|NCT03521817|Other|No Alcohol|This group will not consume alcohol. Thus 0 kcal/d will come from alcohol
15916761|NCT03521804|Device|SoundBite™ Crossing System Active Wire 14|Successful crossing of the CTO into the true arterial lumen distal to the occlusion, following use of the SoundBite™ Crossing Wire during the procedure and using antegrade only approach. An antegrade only approach may involve Antegrade Dissection Re-Entry (ADR) with or without the use of specialized devices (i.e. Stingray). The absence of successful retrograde crossing of a collateral will still be considered an antegrade only approach.
15916762|NCT03521791|Drug|PRO-155|"PRO-155 (Zebesten ofteno®) Active agent: bromfenac 0.90 mg / mL, dropper bottle of low density polyethylene for multidose administration in the form of an ophthalmic solution of 5 mL (milliliters). Sanitary registry in Mexico: 108M2014
~Sodium hyaluronate 0.4% [Lagricel ofteno®] 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac"
15916763|NCT03521791|Other|Placebo|"The placebo is constituted by agents, additives and vehicles, of the formulation PRO-155 without pharmacological activity. It is dispensed in dropper bottle of low density polyethylene for multi-dose administration in the form of ophthalmic solution of 5 mL
~Sodium hyaluronate 0.4% (Lagricel ofteno®) 1 drop 3 times a day in the period of vigil in the conjunctival cul-de-sac"
15916764|NCT03521778|Other|Fascial Distortion Model|"Patients will receive manual treatment according to FDM procedures:
~Triggerbands - therapist put a pressure by the thumb along the presented pathway.
~Continuum Distortions - therapist put a pressure by the thumb at the exact place of feeling of pain.
~Folding Distortions - therapist conduct traction or compression of the affected joint.
~Herniated Triggerpoint - therapist put a pressure by the thumb at the place where HTP occurs.
~Cylinder Distortions - therapist compress and stretch by the hands affected area.
~Tectonic Fixation - Therapist compress and stretch affected area by the hands or tools like vacuum bubble."
15916765|NCT03521778|Other|Mulligan Concept|"Patients will receive manual treatment according to Mulligan Concept procedures:
~MWM- Mobilization With Movement- application can be defined as the application of a sustained passive force/glide.
~NAG - Natural Apophyseal Glide - application can be defined as the oscillatory mobilization techniques from the middle to the end of the range of motion.
~SNAG- Sustained Natural Apophyseal Glide- They are weight bearing techniques: all procedures are done with the patient sitting or in standing. They are mobilisations with active movement followed by passive over pressure."
15916766|NCT03521778|Other|Traditional physiotherapy|"Patients will receive traditional physiotherapy:
~Exercises, laser treatment, magnetic field therapy, ultrasound treatment, light treatment"
15917006|NCT03519971|Radiation|Radiation|5 fractions/ week for ~6 weeks (±3 days) (Total 60 Gy)
15916767|NCT03521765|Other|Cancer education|Those participants in the OT intervention group were given a consultation based on a CRC education handbook by an occupational therapist for discharge preparation (about 30 minutes) and after each follow-up visit to the clinic (about 15-20 minutes); the non-intervention group participants were given a CRC education handbook (the same handbook) only for discharge preparation. For the first OT consultation, in the first 15 minutes, the occupational therapist educated the participants based on the CRC education handbook chapter by chapter. The next 15 minutes, the occupational therapist interacted with the participants and provided them customized lifestyle suggestions. For the each following (second and third) consultations, occupational therapists interacted with the participants and provided customized suggestions based on the participants' lifestyle at home.
15916768|NCT03521752|Other|Specific Exercise Program|4 weeks of exercise classes, 2 to 3 times a week for a total of 10 sessions. Classes last approximately 40 minutes. The sessions included balance training, motor strength, endurance and flexibility. The training sessions were divided into warm-up, main activity and finally relaxation.
15916769|NCT03521726|Drug|Amoxicillin|Twenty patients receive Intraluminal Amoxicillin eradication for H. pylori.
15916770|NCT03521726|Drug|Rabeprazole, Amoxicillin|Patients fail to achieve intraluminal eradication of H. pylori will be assigned to the oral antibiotic rescue therapies with high dose dual therapy (Rabeprazole, Amoxicillin) for 14 days.
15916771|NCT03521713|Drug|EPORON|"Strength : 3000 IU/0.3 mL, 5000 IU/0.5 mL, 6000IU/0.6 mL
~Formulation : Solution in PFS"
15916772|NCT03521713|Drug|EPREX|"Strength : 2000 IU/0.3 mL, 3000 IU/0.5 mL, 4000IU/0.6 mL
~Formulation : Solution in PFS"
15916773|NCT03521700|Drug|Rosuvastatin|For patients who were assigned to receive intensive lipid lowering, 10 mg/d rosuvastatin was initially prescribed and target LDL-C was < 1.8mmol/L. For patients who were assigned to receive conventional lipid lowering, 5 mg/d rosuvastatin was initially prescribed and target LDL-C was ≥1.8mmol/L, <3.3mmol/L.
15916774|NCT03521687|Drug|Apremilast|30 mg BID
15916775|NCT03521674|Device|pregnancy termination|Second trimester pregnancy termination for fetal anomali or in utero mord fetus will be done
15916776|NCT03521661|Procedure|Kyphoplasty|Fractured vertebral body was reduced with an intravertebral expander and was cement augmented thereafter
15916777|NCT03521648|Procedure|PAE|Prostatic artery embolization
15916778|NCT03521648|Procedure|TURP|Transurethral resection of the prostate
15916779|NCT03521648|Procedure|Other|Other surgical procedures for BPH treatment including holmium laser enucleation of the prostate, open prostatectomy, thulium laser vaporization, resection or enucleation, transurethral incision of the prostate
15916780|NCT03521635|Drug|Pramipexole SR|Tablets
15916781|NCT03521635|Drug|Pramipexole IR|Tablets
15916782|NCT03521622|Behavioral|brief counseling|Brief counseling for motivated smoker 5 As model Brief counseling for not motivated smokers 5 Rs model Brief counseling for motivated risky drinkers simple advice Brief counseling for not motivated risky drinkers brief alcohol intervention
15916783|NCT03521609|Behavioral|Emotional intelligence intervention|Brief group intervention based on emotional intelligence
15916784|NCT03521596|Other|MRD and clonal evolution|Patient evaluation at the time of diagnosis and during the disease course using highly sensitive techniques
15916785|NCT03521570|Radiation|IMRT|Undergo intensity-modulated radiation therapy
15916786|NCT03521570|Biological|Nivolumab|Given IV
15916787|NCT03521557|Behavioral|Gaze and Postural Stability|The duration and content of the GPS intervention is specifically designed to focus on gradually increasing difficulty of gaze and postural stability exercises.
15916788|NCT03521557|Behavioral|Standard Care Control|The Standard Care Control intervention is specifically designed to be focused on improving overall endurance and lower extremity muscular strength.
15916789|NCT03521544|Other|Self-myofascial release|The subjects roll a foam roller under a determinated part of the body to self-massage that area.
15916790|NCT03521518|Diagnostic Test|Conner's Continuous Performance Test-3|CPT-3 allows quantitative assessment of visuospatial, attention and reaction time in patients being evaluated for Normal Pressure Hydrocephalus undergoing a CSF tap test.
15916791|NCT03521505|Drug|Dexmedetomidine arm|Induction: Dexmedetomidine 1ug/kg infusion for 10 minutes. 5 mg/kg alfentanil (1:10 dilution) slow injection 2 min before complete Dexmedetomidine induction Maintenance: Dexmedetomidine 0.5~1.4ug/kg/hour infusion±0.2ug/kg/hour to maintain stable vital signs and The Observer Assessment of Alertness and Sedation scale (OAA/S) 3~2. the infusion rate was increased by 0.2ug/kg/hour if the patient persistently had eye opening, talked, or became irritable and interfered with the procedure. The infusion rate was reduced by 0.2ug/kg/hour, if the following adverse events occurred: hypoxemia (SpO2 < 90%) or hypotension (mean arterial pressure (MAP) < 65 mmHg, or systolic blood pressure (SBP) < 90 mmHg) in any duration
15916792|NCT03521505|Drug|Propofol arm|"5 mg/kg alfentanil (1:10 dilution) slow injection 2 min before induction Induction: The initial effect-site concentration (Ce) of propofol was targeted to 2.0 μg/ml for induction (Schneider model of target-controlled infusion (TCI), Injectomat total intravenous anaesthesia (TIVA) Agilia, Fresenius Kabi, France). If OAA/S did not reach 3 while Ce achieved 2.0 μg/ml, Ce was increased by 0.2 μg/ml every 90 seconds until OAA/S 3~2.
~Maintenance: the Ce was increased by 2.0 μg/mL every 90 seconds if the patient persistently had eye opening, talked, or became irritable and interfered with the procedure. The Ce was reduced by 0.2 μg/ml every 90 seconds, if the following adverse events occurred: hypoxemia (SpO2 < 90%) or hypotension (mean arterial pressure (MAP) < 65 mmHg, or systolic blood pressure (SBP) < 90 mmHg) in any duration."
15916793|NCT03521492|Diagnostic Test|serum vitamin D , calcium , parathyroid hormone and albumin level|measuring serum level of Vit. D, PTH, Calcium, and Albumin levels
15916794|NCT03521479|Drug|Squaric Acid Dibutyl Ester|Repeat topical application of 2% and 0.5% squaric acid dibutyl ester (SADBE) in subjects with frequent herpes labialis (4 or more episodes in the previous 12 months).
15916795|NCT03521466|Behavioral|Smoking Cessation Counseling|Trained medical students will visit patients inpatient while hospitalized and provide smoking cessation counseling and recommend Nicotine Replacement Therapy. They will continue to follow these patients for 2 months after discharge and provide telephone-based counseling.
15916796|NCT03521453|Other|PEPPER robot|Presence of a Robot (PEPPER Robot), designed and programmed to give informations, using a screen and vocal. All the patients in the second period will have access to,the robot, while waiting for the visit.
15917320|NCT03517540|Drug|Tropifexor (LJN452)|Comparison with monotherapy and different combination doses
15916797|NCT03521440|Behavioral|Psychomotor Massage|Sessions will be conducted by a graduated therapist, experienced in Psychomotor Massage and weekly supervised by a specialist in this therapeutic approach. The Psychomotor Massage involves smoothly touching the head, upper and lower limbs, followed by micro-stretching and slow mobilisations of upper and lower limbs.
15916798|NCT03521440|Behavioral|Progressive Muscle Relaxation|Sessions will be conducted by a graduated therapist, experienced in Progressive Muscle Relaxation, and weekly supervised by a specialist in this therapeutic approach. The Progressive Muscle Relaxation protocol consists in tensing and releasing 16 muscle groups for several seconds, following a specific order.
15916799|NCT03521427|Other|Intensive bimanual therapy|Ninety hours of intensive bimanual therapy
15916800|NCT03521427|Other|Intensive neurodevelopmental therapy|Ninety hours of intensive neurodevelopmental therapy
15916801|NCT03521414|Device|Bispectral index (BIS) monitoring|When the patients were taken to the operation table, they were monitored with the BIS. we used sevoflurane drug
15916802|NCT03521414|Drug|Sevoflurane|we used sevoflurane drug at inoperative
15916803|NCT03521401|Behavioral|Exercise|Participants assigned to the exercise group will undergo structured, progressive resistance and aerobic exercise for 8 weeks. Resistance training and aerobic training will each be completed twice weekly for a total of 16 resistance and 16 aerobic exercise training sessions.
15916804|NCT03521388|Behavioral|Take care of your mood (CUIDA TU ANIMO in Spanish)|The adolescents will be registered in the Website www.cuidatuanimo.org
15916805|NCT03521388|Other|Control|The adolescents will visit the Website www.cuidatuanimo.org, but they can not register
15916806|NCT03521375|Procedure|Open Surgery|Conventional open surgery is undertaken through a single incision +/- rib resection and with rib spreading. The operation is performed under direct vision with isolation of the hilar structures (vein, artery and bronchus) which are dissected, ligated and divided in sequence and the lobe of lung resected. The procedures may be undertaken using ligatures, over sewing or with staplers. Lymph node management is undertaken in accordance with the International Association of the Study of Lung Cancer (IASLC) recommendations where a minimal of 6 nodes / stations are removed, of which 3 are from the mediastinum that includes the subcarinal station. The thoracotomy is closed in layers starting from pericostal sutures over the ribs, muscle, fat and skin layers.
15916807|NCT03521375|Procedure|Video Assisted Thoracoscopic Surgery (VATS)|VATS lobectomy is undertaken through one to four keyhole incisions without rib spreading. The use of 'rib spreading' is prohibited as this is the key intra-operative manoeuvre which disrupts tissues and causes pain (and is used in open surgery). The procedure is performed with videoscopic visualisation without direct vision. The hilar structures are dissected, stapled and divided. Endoscopic ligation of pulmonary arterial branches may be performed. The fissure is completed and the lobe of lung resected. Lymph node management is the same as described for open surgery. The incisions are closed in layers and may involve muscle, fat and skin layers. This definition of VATS lobectomy is a modification of CALGB 39802.
15916808|NCT03521362|Device|MyT1DHero|MyT1DHero is an app with two separate interfaces, one for the parent and one for the child, that work together to help them communicate about diabetes management. The child receives system reminders to enter their blood glucose numbers, and parents receive a notification about each blood glucose test their child enters. Parents are also able to use the app to communicate with their child about their plan for care. The app has customizable blood glucose reminders and ranges, videos of support from other adolescents with T1D, snack lists, and other educational information on T1D.
15916809|NCT03521362|Device|Other T1D Mobile App|A mobile app will be used in this control/comparison group that only has blood sugar testing reminders and logging capabilities. There will be no other components of the app.
15916810|NCT03521349|Other|Whole Egg Intervention|Participants will consume an isocaloric muffin containing important bioactives from whole eggs.
15916811|NCT03521349|Other|Egg White Control|Participants will consume an isocaloric muffin containing egg white, lacking important bioactives from whole eggs.
15916812|NCT03521336|Drug|Umbilical Cord Mesenchymal Stem Cells|Intrathecal Transplantation of Umbilical Cord Mesenchymal Stem Cells
15916813|NCT03521336|Drug|Placebo|Saline，Sham operation
15916814|NCT03521323|Drug|Umbilical Cord Mesenchymal Stem Cells|Intrathecal Transplantation of Umbilical Cord Mesenchymal Stem Cells
15916815|NCT03521323|Drug|Placebos|Placebos: Saline，Sham operation
15916816|NCT03521310|Procedure|Skin-to-skin|Neonates will get Skin-to-skin Contact with parent/caregiver continuously the first 6 hours after birth and as much as possible the first 72 hours after birth.
15916817|NCT03521310|Procedure|Conventional care|Neonates will get Conventional care the first 72 hours after birth
15916818|NCT03521297|Drug|Probiotic|UDCA combined probiotic
15916819|NCT03521297|Dietary Supplement|Placebo|UDCA combined placebo
15916820|NCT03521284|Other|Parental educational program|Behavior: psychotherapy, life hygiene advice
15916821|NCT03521284|Other|Questionnaires|knowledge questionnaire + parental anxiety questionnaire
15916822|NCT03521258|Device|Dehydrated Human Amnion/Chorion Membrane|
15916823|NCT03521258|Procedure|Flap-Based Reconstructive Surgery|Standard of Care surgical intervention
15916824|NCT03521245|Other|RNA sequencing|Next Generation Sequencing of RNA from tumor samples, rRNA-depleted.
15916825|NCT03521245|Other|Transcriptome analysis|Analysis of RNA-seq data using the Oncobox algorithm.
15916826|NCT03521245|Drug|Trastuzumab|Standard Trastuzumab treatment regimen recommended for breast cancer
15916827|NCT03521245|Drug|Chemotherapy|Standard chemotherapy regimen recommended for breast cancer
15916828|NCT03521232|Drug|Niclosamide|enema given twice daily for 6 weeks
15916829|NCT03521219|Drug|Apatinib|Apatinib 500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops.
15916830|NCT03521206|Behavioral|ACP+ programme|Training program for nursing home staff.
15916832|NCT03521167|Drug|Ketamine|"Intraoperatively use. 0.5 mg/kg with induction bolus, followed by 5mcg/kg/min infusion after induction.
~Continue up to 1 hour prior to extubation. maximum total dose 3mg/kg."
15916833|NCT03521167|Drug|Lidocaine|Intraoperatively use. start lidocaine infusion at 2mg/min after anesthesia induction, and continue up to 1 hour prior to extubation.
15947893|NCT03280316|Drug|M receptor antagonist|Tolterodine
15916834|NCT03521167|Drug|Dexmedetomidine|Intraoperatively use. start dexmedetomidine infusion at 0.5 mcg/kg/min after anesthesia induction, and continue up to 1 hour prior to extubation.
15916835|NCT03521167|Drug|Gabapentin|Postoperatively use. 300 mg PO TID starting POD1 until discharge Use lower dose for >65y or if patient having significant sedation/dizziness
15916836|NCT03521167|Drug|Tylenol|Postoperatively use. 1000 mg PO Q8hr starting POD0 until discharge (max 3000 mg in 24hrs) Reduce to 650 mg PO Q6h if <70kg
15916837|NCT03521167|Drug|Gabapentin Pill|Pre-operatively use. 300mg PO up to 1 hour before OR time Reduce to 100 mg PO in patients >65y or with GFR < 50 Consider dose reduction in patients with sleep apnea
15916838|NCT03521167|Drug|Tylenol Pill|Pre-operatively use. 1000 mg PO up to 1 hour before OR time Reduce to 650 mg PO if <70kg Don't use if h/o liver disease or anticipated liver injury (right heart failure, pulmonary hypertension, etc leading to systemic venous congestion)
15916841|NCT03521141|Drug|Nicotine patch|FDA-approved smoking cessation pharmacotherapy
15916842|NCT03521141|Drug|Varenicline|FDA-approved smoking cessation pharmacotherapy
15916843|NCT03521141|Genetic|Nicotine metabolism|Information on nicotine metabolism will be used to inform selection of medication.
15916844|NCT03521141|Genetic|Genetically-informed lung cancer risk score|This intervention uses information from a person's genes and smoking and family medical histories to estimate lung cancer risk compared to current smokers.
15916845|NCT03521141|Behavioral|"NCI Clearing the Air"|A booklet-led intervention designed by the NCI to support cessation at any stage of a quitter's journey, whether they are still thinking about quitting, have made the decision to quit, or have already taken steps to quit and just need help maintaining their new lifestyle.
15916846|NCT03521128|Procedure|radiological tubal blockage|In radiological tubal blockage group, under the fluoroscopy of X-ray, after confirming HX by HSG, selective catheterization will be done for the affected tube and micro spring coils will be put in to the interstitial tube and isthmus through micro catheter. The micro spring coil will be placed into the proximal end of the Fallopian tube (unilateral or bilateral depending on whether one or two HX were present) through micro catheter under the fluoroscopy of X-ray. Then HSG will be carried out to check the position of the micro spring coil and confirm complete blockage. Four weeks after the radiological procedure, a HSG will be performed to recheck the position of the micro spring coil and complete blockage of the tubes. FET is proceeded in the next menstrual cycle after HSG examination.
15916847|NCT03521128|Procedure|laparoscopic salpingectomy|In the laparoscopic salpingectomy group, after confirming HX, a unilateral or bilateral salpingectomy will be performed in a standard manner, depending on whether unilateral or bilateral HX are present. In women with extensive pelvic adhesions during laparoscopy, proximal tubal ligation will be performed as an alternative procedure to salpingectomy. FET is proceeded in the next menstrual cycle after the laparoscopic operation.
15916848|NCT03521115|Behavioral|Smart Choices 4 Teens|This is a web-based prevention program designed to convey information about alcohol and relationships and the types of choices that they are making regarding these topics. General communications was another core element of the program that provided parents and teens with some key elements of talking to each other.
15916849|NCT03521102|Drug|Acetaminophen 1000mg IV|1000mg of IV acetaminophen in 100ml of normal saline, administered as an intravenous drip over 10 minutes + 2ml of normal saline, administered as a slow intravenous push
15916850|NCT03521102|Drug|Hydromorphone 0.5 mg IV|100ml of normal saline, administered as an intravenous drip over 10 minutes, + 0.5mg of IV hydromorphone in 2ml of normal saline, administered as a slow intravenous push
15916851|NCT03521089|Device|Soterix Medical 1x1 Low Intensity Transcranial Electrical Stimulator (tES) Model 2001|Transcranial direct current stimulation works by sending constant, low direct current through the electrodes. When these electrodes are placed in the region of interest, the current induces intracerebral current flow. This current flow then either increases or decreases the neuronal excitability in the specific area being stimulated based on which type of stimulation is being used. This change of neuronal excitability leads to alteration of brain function, which can be used in various therapies as well as to provide more information about the functioning of the human brain.
15916852|NCT03521076|Device|Virtual Reality|Participants will have the opportunity to choose a game or relaxation experience to utilize during a botulinum toxin injection to distract from pain and anxiety during one visit. Virtual Reality will not be available during the other visit. AppliedVR has a number of games and relaxation experiences available for participants to chose from.
15916853|NCT03521063|Drug|Budesonide|Drug: Budesonide inhalation suspension
15916854|NCT03521063|Drug|Poractant Alfa|Drug: Poractant alfa intratracheal suspension
15916855|NCT03521063|Drug|Saline|Sodium chloride injection 0.9%
15916856|NCT03521050|Device|defibrillator lead|observation of long-term performance of defibrillator leads
15916858|NCT03521024|Other|poly ether ketone ketone|Polyetherketoneketone (PEKK) forms a group of high-performance thermoplastic polymers. PEKK shows excellent biocompatibility and exhibits outstanding properties such as high wear resistance and high compressive (246 MPa), flexural (5.0GPa), and tensile strengths (115 MPa). The material is lightweight, allows shock absorption, and can be veneered with various commercially available dental materials
15916859|NCT03521024|Other|lithium disilicate|well documented in the literatures as successful restoration modality.
15916860|NCT03521011|Device|MSCT|Non enhanced MSCT Abdomen
15916861|NCT03520998|Drug|GRF6019|GRF6019 for IV infusion
15916862|NCT03520985|Drug|Pomalidomide|"Pomalidomide (4 mg p.o.) will be administered on every other day of each 28-day treatment cycle.
~Treatment duration:
~Treatment cycles are repeated until confirmed disease progression."
15917187|NCT03518450|Procedure|Adductor Canal Block|Interfascial block that targets mainly the saphenous nerve.
15916863|NCT03520985|Drug|Dexamethasone|"For patients ≤ 75 years of age:
~Low-Dose Dexamethasone (40 mg p.o.) will be administered once per day on days 1, 7, 15, and 21 of a 28-day cycle.
~For patients > 75 years of age:
~Low-Dose Dexamethasone (20 mg p.o.) will be administered once per day on days 1, 7, 15, and 21 of a 28-day cycle.
~Treatment duration:
~Treatment cycles are repeated until confirmed disease progression."
15916864|NCT03520972|Drug|PB-119 75ug|60 eligible patients will be included in this group
15916865|NCT03520972|Drug|PB-119 150ug|60 eligible patients will be included in this group
15916866|NCT03520972|Drug|PB-119 200ug|60 eligible patients will be included in this group
15916867|NCT03520972|Drug|placebo|60 eligible patients will be included in this group
15916868|NCT03520959|Biological|LV305|Administered via subcutaneous (SC) injection.
15916869|NCT03520959|Biological|G305|Administered via intramuscular (IM) injection.
15916870|NCT03520959|Other|LV305-matching placebo|Administered via SC injection.
15916871|NCT03520959|Other|G305-matching placebo|Administered via IM injection.
15916872|NCT03520946|Drug|Ramucirumab|8 mg/kg iv over 60 min on d1+15, q4w
15916873|NCT03520946|Drug|TAS 102|35mg/m2 p.o. twice daily (BID) d1-5 and d8-12, q4w
15916874|NCT03520933|Diagnostic Test|PGT-A|PGT-A will be carried out following the usual clinical practice: Trophectoderm biopsy samples from blastocysts are analyzed by NGS to screen for numerical chromosomal abnormalities.
15916875|NCT03520933|Diagnostic Test|niPGT-A|Non-invasive preimplantation genetic test for embryo aneuploidy analyzing the spent culture media where the embryo is incubated up to the time of transfer or freezing. This media contains traces of embryonic cell-free DNA (cfDNA) that can represent the genetic load of the embryo.
15916878|NCT03520907|Drug|Transversalis Fascia Plane Block|block will be performed under real-time ultrasound guidance
15916879|NCT03520907|Drug|Ilioinguinal/iliohypogastric Nerve Block|block will be performed under real-time ultrasound guidance
15916880|NCT03520894|Radiation|Neoadjuvant radiotherapy|single 21 Gy fraction of Radiotherapy before surgery
15916881|NCT03520881|Other|Pediatric ASTHMA-Educator mobile application|This intervention represents a mobile application (accessible by iOS and Android devices) that provides asthma education through games and videos.
15916882|NCT03520868|Diagnostic Test|Monitoring Anti Factor Xa level|Each patient will have baseline Anti-Factor Xa assay checked. During the procedure, Anti-Factor Xa assay is checked concurrently with ACT after heparin bolus and infusion.
15916883|NCT03520855|Other|Serious game|DIVE software will be accessible via internet, children and parents will have to their disposition a room at the hospital specifically to work on the software. The DIVE software is organized in chapters, each matches an item of the therapeutic education process and ends with a knowledge assessment. The child has to end every chapter and succeed every evaluation to pursue on the next chapter. Measures will be taken in order to avoid contamination bias between groups. Children will have to connect to DIVE 2 times per week for a time duration of at last 1 hour.
15916884|NCT03520855|Behavioral|ETP|"Initial therapeutic education only will be applied in this group, with the help of doctors and nurses, based on theoretical educational lessons, reported on the AJD book.
~Health education sessions will also be taught by nurses."
15916885|NCT03520842|Drug|Methotrexate|Given PO
15916886|NCT03520842|Other|Pharmacokinetic Study|Correlative studies
15916887|NCT03520842|Drug|Regorafenib|Given PO
15916888|NCT03520829|Device|Intuitive Plan|dosimetric planning software
15916889|NCT03520816|Other|Burn Physiotherapy Protocol|It consisted of parameters such as early mobilisation and ambulatory training, chest physiotherapy, and both active and passive normal joint movement exercises.
15916890|NCT03520803|Other|Enhanced recovery after surgery protocol|Experimental enhanced recovery protocol for pre-surgery and post surgery
15916891|NCT03520790|Drug|Gemcitabine|Gemcitabine is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.
15916892|NCT03520790|Drug|Nab-paclitaxel|Nab-paclitaxel is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.
15916893|NCT03520790|Drug|Paricalcitol|Paricalcitol (IV or oral) is a man-made form of vitamin D. It is thought to work by blocking a signal in the cancer tumor cells that leads to growth and spreading of the tumor.
15916894|NCT03520790|Other|Placebo|Placebo
15916895|NCT03520777|Other|Art Intervention|Type of artist intervention will be determined by the subject and the assigned artist.
15916896|NCT03520764|Dietary Supplement|New infant formula with synbiotics|Infants are fed with synbiotics formula for 17 weeks from the date of enrollment.
15916897|NCT03520764|Dietary Supplement|Standard infant formula with prebiotics|Infants are fed with prebiotics formula for 17 weeks from the date of enrollment.
15916898|NCT03520751|Drug|scAAV1.tMCK.NTF3|gene vector
15916899|NCT03520738|Other|Blood samples|Blood samples on an empty stomach
15916900|NCT03520738|Other|Urinary samples|first urinary in the morning
15916901|NCT03520725|Other|No Intervention|This gruop did not have an intervention
15916902|NCT03520725|Dietary Supplement|Pineapple snack bar|30 g daily of pineapple snack bar
15916903|NCT03520725|Dietary Supplement|Mango snack bar|30 g daily of mango snack bar
15916904|NCT03520712|Biological|Valoctocogene Roxaparvovec|Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Hemophilia A
15916905|NCT03520686|Drug|N-803 + Pembrolizumab|"The treatment plan in the experimental arm will consist of repeated 3-week cycles for a maximum treatment period of 2 years, in accordance with the following dosing regimen:
~Day 1, every 3 weeks:
~Pembrolizumab (200 mg intravenous infusion [IV])
~N-803 (15 μg/kg subcutaneously [SC])"
15916906|NCT03520686|Drug|N-803 + Carboplatin + Nab-paclitaxel + Pembrolizumab|"The treatment plan in the experimental arm of Cohort B will consist of an induction period of repeated 3-week cycles for 4 cycles then a maintenance period of repeated 3-week cycles for a maximum treatment period of 2 years, in accordance with the following dosing regimen:
~Induction (4 cycles):
~Day 1, every 3 weeks:
~Carboplatin (up to 900mg IV)
~Nab-paclitaxel (100mg/m² IV)
~Pembrolizumab (200mg IV)
~N-803 (15 μg/kg SC)
~Day 8:
~Nab-paclitaxel (100mg/m² IV)
~Day 15:
~Nab-paclitaxel (100mg/m² IV)
~Maintenance:
~Day 1, every 3 weeks:
~Pembrolizumab (200mg IV)
~N-803 (15 μg/kg SC)"
15916907|NCT03520686|Drug|N-803 + Cisplatin or Carboplatin + Pembrolizumab + Pemetrexed|"The treatment plan in the experimental arm of Cohort C will consist of an induction period with repeated 3-week cycles for 4 cycles, then a maintenance period of repeated 3-week cycles for a maximum treatment period of 2 years, in accordance with the following dosing regimen:
~Induction (4 cycles):
~Day 1, every 3 weeks:
~Cisplatin (75mg/m²) or Carboplatin (up to 900mg IV)
~Pembrolizumab (200mg IV)
~Pemetrexed (500mg/m² IV)
~N-803 (15 μg/kg SC)
~Maintenance:
~Day 1, every 3 weeks:
~Pembrolizumab (200mg IV)
~N-803 (15 μg/kg SC)"
15916908|NCT03520686|Drug|Pembrolizumab|"Drug: Pembrolizumab
~The reference treatment will consist of repeated 3-week cycles for a maximum treatment period of 2 years, in accordance with the following dosing regimen:
~Day 1, every 3 weeks:
~• Pembrolizumab (200 mg IV)"
15916909|NCT03520686|Drug|Carboplatin + Nab-paclitaxel or Paclitaxel + Pembrolizumab|"The treatment plan in the control arm of Cohort B will consist of an induction period of repeated 3-week cycles for 4 cycles then a maintenance period of repeated 3-week cycles for a maximum treatment period of 2 years, in accordance with the following dosing regimen:
~Induction (4 cycles):
~Day 1, every 3 weeks:
~Carboplatin (up to 900mg IV)
~Nab-paclitaxel (100mg/m² IV) or Paclitaxel (200mg/m² IV)
~Pembrolizumab (200mg IV)
~Day 8:
~Nab-paclitaxel (100mg/m² IV) -if assigned to receive
~Day 15:
~Nab-paclitaxel (100mg/m² IV) -if assigned to receive
~Maintenance:
~Day 1, every 3 weeks:
~Pembrolizumab (200mg IV)"
15916910|NCT03520686|Drug|Cisplatin or Carboplatin + Pembrolizumab + Pemetrexed|"The treatment plan in the control arm of Cohort C will consist of an induction period with repeated 3-week cycles for 4 cycles, then a maintenance period of repeated 3-week cycles for a maximum treatment period of 2 years, in accordance with the following dosing regimen:
~Induction (4 cycles):
~Day 1, every 3 weeks:
~Cisplatin (75mg/m²) or Carboplatin (up to 900mg IV)
~Pembrolizumab (200mg IV)
~Pemetrexed (500mg/m² IV)
~Maintenance:
~Day 1, every 3 weeks:
~Pembrolizumab (200mg IV)"
15916911|NCT03520673|Diagnostic Test|Urodynamics|All the men in the study will receive the urodynamics procedure as a reference test.
15916912|NCT03520660|Drug|Epclusa|sofosbuvir/velapatasvir combination (Epclusa)
15916913|NCT03520647|Drug|Cyclophosphamide|This research protocol is therefore designed to evaluate the safety and effectiveness of using an unmanipulated G-CSF mobilized peripheral stem cell allograft from a haploidentical donor and post-transplant cyclophosphamide for patients with SAA, or SAA evolving to MDS, or PNH that has proven to be refractory to conventional immunosuppressive therapy (IST) in patients who lack an HLA-matched donor (sibling/or matched unrelated donor.
15916914|NCT03520647|Other|Peripheral Blood Stem Cells|This research protocol is therefore designed to evaluate the safety and effectiveness of using an unmanipulated GCSF mobilized peripheral stem cell allograft from a haploidentical donor and post-transplant cyclophosphamide for patients with SAA, or SAA evolving to MDS, or PNH that has proven to be refractory to conventional immunosuppressive therapy (IST) in patients who lack an HLA-matched donor (sibling/ or matched unrelated donor.
15916915|NCT03520634|Other|PD-L1 PET imaging|PD-L1 PET imaging
15916916|NCT03520621|Other|No intervention|no intervention
15916917|NCT03520595|Drug|Arnica 200 drug 3 pills,3 times daily for 3 days|CLP with ostectomy done in patients whose biologic width and crown height is insufficient
15916918|NCT03520595|Drug|Diclofenac Sodium 50mg twice daily|CLP with ostectomy done in patients whose biologic width and crown height is insufficient
15916919|NCT03520595|Drug|Placebo pills and distilled water 3 pills,3 times daily|CLP with ostectomy done in patients whose biologic width and crown height is insufficient
15916920|NCT03520582|Device|Tube placement|Placement of enteral feeding tubes
15916921|NCT03520569|Drug|Octreotide|we are using it to block insulin secretion from the pancreas
15916922|NCT03520569|Drug|Insulin|we are using to replace basal insulin and in two protocols to raise insulin concentrations during the insulin clamp
15916923|NCT03520569|Drug|Dextrose 20% solution|We are using dextrose to maintain glycemia level
15916924|NCT03520543|Drug|[11C]Yohimbine|Each subject will receive an intravenous (IV) bolus injection of [11C]Yohimbine at a dose of 370 MegaBecquerel (MBq) ± 10% with concomitant arterial blood sampling. The distribution of [11C]Yohimbine in brain will be measured by dynamic PET scans obtained from the time of injection for up to 90 minutes along with measurement of the tracer input function with arterial samples for intact tracer and metabolites to establish the total and regional compartmental kinetics of [11C]Yohimbine.
15916925|NCT03520543|Drug|[11C]Yohimbine (Part B1) and [11C]Yohimbine + clonidine (Part B2)|"Part B1 : Test Retest Variability will be assessed on percent difference in the binding potential following [11C]Yohimbine PET scan (IV bolus injection of [11C]Yohimbine at a dose of 370 MBq ± 10%) obtained at least 1 week after [11C]Yohimbine PET scan of part A.
~Part B2 : Occupancy of alpha2-adrenergic receptors in brain by clonidine will be evaluated by comparing the binding potential of [11C]Yohimbine (IV bolus injection of [11C]Yohimbine at a dose of 370 MBq ± 10%) after single oral dose of clonidine (0,15mg) to the binding potential of [11C]Yohimbine obtained at baseline (part A)."
15916926|NCT03520530|Device|Mouth Guard|Patient will wear mouth guard while pushing in the second stage of labor
15916927|NCT03520517|Drug|BHV-0223|BHV-0223, 40 mg BID
15916928|NCT03520504|Radiation|Proton craniospinal irradiation (CSI)|Patients will be enrolled to receive 30Gy (RBE) in 3Gy (RBE) or 25Gy (RBE) in 2.5Gy (RBE) fractions course of proton CSI.
15916929|NCT03520491|Drug|Nivolumab|Nivolumab 3 mg/kg or Nivolumab 1 mg/kg
15916930|NCT03520491|Drug|Ipilimumab|Ipilimumab 3 mg/kg
15916931|NCT03520491|Procedure|Radical cystectomy|RC-PLND is to take place within 60 days from the last dose of treatment.(After week 10 for cohort 1, after week 11 for cohort 2, and after week 9 for cohort 3.)
15916932|NCT03520478|Drug|SHR3680|Tablet. Specifications of 80 mg; orally, once a day
15916933|NCT03520478|Drug|Bicalutamide|Tablet. Specifications of 50 mg; orally, once a day
15916934|NCT03520465|Device|DynaMesh®-CICAT longitudinal measure 10x35 cm|
15916935|NCT03520452|Other|Green coffee extract|Reconstituted in water and given to subjects
15916936|NCT03520452|Other|Placebo|Placebo
15916937|NCT03520439|Drug|Mifepristone|Oral mifepristone 10mg (first menstrual third days), 1 times a day, 12 weeks, fasting or taking 2 hours after eating
15916938|NCT03520439|Drug|Placebo|Oral Placebo Oral Tablet 1# (first menstrual third days), 1 times a day, 12 weeks, fasting or taking 2 hours after eating
15916971|NCT03520205|Procedure|Continuous Epidural|Patient will be given 6 mL/hour of Bupivacaine 0.25% for intraoperative analgesia and continued epidural 6 mL/hour Bupivacaine 0,125% as postoperative analgesia in 24 hours.
15916939|NCT03520426|Device|Votiva RF|The Votiva system is approved by the U.S. Food and Drug Administration for treatment of sexual dysfunction as well as in combination with Kegel exercises for tightening of the muscles of the pelvic floor to increase muscle tone. One part of the system, the fractora handpiece, is approved for tissue coagulation for the purpose of skin rejuvenation. The Votiva has two hand pieces, Forma and Fractora, which have been cleared by the United States Food and Drug Administration (FDA) and are used during dermatological procedures.
15916940|NCT03520413|Other|PRACTICE-DM|Five-component diabetes intervention: 1) telemonitoring; 2) self-management support; 3) diet/activity support; 4) medication management; and 5) depression support.
15916941|NCT03520413|Other|Standard VA Home Telehealth|Standard VA HT care coordination and telemonitoring.
15916942|NCT03520400|Behavioral|Exercise Therapy|Patients will adhere to one year of exercise therapy for the investigators' study. At minimum, subjects will aim to participate in approximately 30-60 minutes of aerobic exercise 5-7 days per week and 15-30 minutes of resistance/anaerobic exercise 2-3 times per week.
15916943|NCT03520387|Procedure|Lumbar medial branch nerve radiofrequency ablation (LRFA)|Radiofrequency ablation of the dorsal rami of the lumbar spinal nerves, using electrode placement parallel to the medial branches, 18G electrodes or larger, and 2 lesions per nerve.
15916944|NCT03520387|Procedure|Simulated LRFA with targeted steroid injections|Performed in an identical fashion to the experimental arm (LRFA), except for medial branch lesioning, which will not be done in simulated LRFA, and 2) the simulated LRFA control group will receive an injection of triamcinolone acetonide at each site where a radiofrequency lesion would normally be applied.
15916945|NCT03520387|Behavioral|AcTIVE-CBT|AcTIVE-CBT involves a standardized CBT protocol for pain, delivered via a video telehealth interface. AcTIVE-CBT also incorporates use of an activity tracker to provide objective feedback on activity levels, which can inform participants' and providers' impressions of goals and progress.
15916946|NCT03520387|Behavioral|TBSCE|TBSCE control is a focused program of CBT involving an initial 60-minute telephone education session by a psychologist; the provision of printed educational materials on chronic pain self-management, and a workbook for CBT self-management; and structured, written plans for weekly practice, reading and homework using the workbook.
15916947|NCT03520374|Diagnostic Test|Ultrasonography|Ultrasonography use for the evaluation of gastric contents
15916948|NCT03520361|Drug|Oral sulfate solution (OSS)|Compositions/177ml : Sodium sulfate 17.5g, Potassium sulfate 3.13g, Magnesium sulfate 1.6g
15916949|NCT03520361|Drug|2L PEG/Asc|Compositions/1L : Sodium chloride 2.89g, Potassium chloride 1.015g, Anhydrous sodium sulfate 7.5g, Polyethylene glycol 3350 100g, Ascorbic acid 4.7g, Sodium ascorbate 5.9g
15916950|NCT03520348|Drug|PRO-167|"Dexpanthenol 5%. Ophthalmic gel produced by Laboratorios Sophia, S.A. of C.V., Zapopan, Jalisco, Mexico.
~Route of administration: ophthalmic"
15916951|NCT03520348|Drug|Corneregel|Dexpanthenol 5%. Ophthalmic gel developed by Bausch and Lomb, Berlin, Germany. Route of administration: ophthalmic
15916952|NCT03520322|Device|Mastoid Oscillator|The oscillator will be placed over the mastoid of their involved ear and secured via an elastic/Velcro headband. The subject is positioned so as to place the endolymphatic duct into a gravitationally dependent orientation (the subject lying on their contralateral side with the face slightly tilted towards the floor). The device is turned on and operated for 30 minutes.
15916953|NCT03520322|Device|Control Device|The control device will be placed over the mastoid of their involved ear and secured via an elastic/Velcro headband. The subject is positioned so as to place the endolymphatic duct into a gravitationally dependent orientation (the subject lying on their contralateral side with the face slightly tilted towards the floor). The device is turned on and operated for 30 minutes.
15916955|NCT03520296|Other|Questionnaire|Questionnaire evaluating well-being in relation to diet and nutrition
15916956|NCT03520283|Other|Interview|Ancillary studies
15916957|NCT03520283|Other|Questionnaire Administration|Ancillary studies
15916958|NCT03520283|Behavioral|System Support Mapping|Complete MAP
15916959|NCT03520257|Drug|Apatinib|Apatinib, a small molecule anti-angiogenic targeted drug that has been demonstrated to be safe and effective after failure of standard chemotherapy for advanced gastric cancer, has been initially successful in phase II clinical trials for the treatment of unresectable advanced HCC patients. The efficacy of ralfiny in the treatment of Oriental population (ORIENTAL study) is better. The randomized, double-blind, multi-center phase III clinical study of apatinib second-line treatment of advanced hepatocellular carcinoma showed a good efficacy and safety. Currently, Phase III clinical studies of apatinib in HCC patients undergoing systemic chemotherapy or sorafenib treatment have progressed. Initial results also showed good efficacy and safety.
15916960|NCT03520257|Device|Radiotherapy|Radiotherapy of tumors and portal vein tumor thrombi can promote further tumor shrinkage, and at the same time, the physiological basis for the recanalization of the original tumor thrombus itself will result in necrosis and fibrosis of the tumor thrombus, completely blocking the blood supply to the tumor portal vein. As a result, blood supply to the other side of the portal vein increases, and hepatocyte regeneration in a healthy liver is promoted, so that the patient can obtain surgical opportunities.
15916961|NCT03520244|Behavioral|Exercise + Holistic Education|The exercise group will undertake a 12-week supervised progressive high intensity interval training program supplemented with 6 bi-weekly group-based holistic education sessions.
15916962|NCT03520231|Drug|Denosumab|RANK Ligand Inhibitor
15916963|NCT03520231|Other|Denosumab Placebo|Placebo
15916964|NCT03520231|Drug|Gemcitabine|Antineoplastic Agent
15916965|NCT03520231|Drug|Carboplatin|Antineoplastic Agent
15916966|NCT03520231|Drug|Cisplatin|Antineoplastic Agent
15916967|NCT03520231|Dietary Supplement|Calcium|Calcium Supplement
15916968|NCT03520231|Dietary Supplement|Vitamin D|Vitamin D Supplement
15916969|NCT03520218|Device|Performance of R-PEM|R-PEM imaging will produce high-sensitivity images with low levels of F-18 FDG and optional subsequent scans performed will display reduced levels of the injected radiotracer.
15916970|NCT03520205|Procedure|Quadratus Lumborum Block|Bilateral block using ultrasound will be performed before surgery and after surgery on patient using Stimuplex 100mm needle with Bupivacaine 0.25% 0.4 mL/kg, maximum dose 25 mL each side under general anaesthesia
15947894|NCT03280303|Other|non-interventional|
15916972|NCT03520166|Other|Medium frequency electrotherapy (interferential currents)|Treatment with medium frequency electrotherapy, interferential currents between 5500 Hz and 8500 Hz (Combi-200®, Gymna®), was performed using transvaginal application. The frequency was increased progressively over the first six sessions (twice a week), starting with a frequency of 5500 Hz until reaching a frequency of 8500 Hz, which remained until the end of treatment.
15916973|NCT03520166|Other|No treatment|No treatment
15916974|NCT03520153|Procedure|Hyperinsulinemic Euglycemic Clamp and 2H20|Test is used to assess insulin effects on hepatic glucose production.
15916975|NCT03520153|Procedure|Hyperglycemic Clamp|Test of beta-cell function and insulin secretion. Involves increasing and maintaining blood glucose concentration with IV variable infusion of dextrose.
15916976|NCT03520153|Diagnostic Test|Oral Glucose Tolerance Test|The oral glucose tolerance test (OGTT) measures the body's ability to use a type of sugar, called glucose, that is the body's main source of energy. An OGTT can be used to diagnose prediabetes and diabetes.
15916977|NCT03520127|Device|Intact Breast Lesion Excision System (BLES)|Intact BLES is an automated, percutaneous biopsy device capable of delivering a surgical quality specimen for histological review of breast abnormalities. It is uniquely suited to maintain lesion architecture within the biopsy sample, providing an opportunity for pathological assessment and the potential avoidance of an open surgical procedure.
15916978|NCT03520114|Device|RP sling placement|A 1.5 cm incision will be made at the mid-urethra through a separate vaginal incision with lateral dissection with Metzembaum scissors. After placement of both trocars, cystoscopy with a 70-degree scope will be performed to assess for bladder and urethral injury. Surgeons will set the tension of the tension-free vaginal tape (TVT) slings so that a spacer can be placed between the sling and the urethra. Sling tensioning will be performed after anterior and apical prolapse is corrected.
15916979|NCT03520114|Device|SIS placement|The sling is introduced through a single anterior vaginal incision of 1.5 cm at the mid-urethra. The sling/needle assembly is advanced behind the ischiopubic rami in a transobturator trajectory toward the obturator space bilaterally.The needle is then removed by simply sliding the fixating tip back out. The other side is then completed in an identical fashion. After the fixation of the two anchors at the 2 and 10 o'clock positions, the patient's bladder is filled with 250 mL of NaCl. Afterward, an intraoperative crede maneuver is performed and the tension adjustment suture is pulled, when necessary, to achieve the desired continence. The mesh will lie in direct apposition to the urethra. The adjustment thread is then cut short and the vaginal incision is closed with an absorbable suture.
15916980|NCT03520101|Procedure|TAVI_ViV procedure with Edwards valve|The TAVR procedure will be performed following the standards of each participating center. No restriction or specific recommendation will be given regarding the approach, general vs. local anesthesia, imaging guidance during the TAVI procedure, and post-procedural TAVI management. The decision for selecting either a 20 or 23mm Edwards valve will be based on 3D CT measurements of the mean inner diameter of the surgical aortic bioprosthesis. A 23mm Sapien 3 valve will be recommended if the inner diameter is >18 mm, and a 20mm valve will be selected if the mean inner diameter is ≤18 mm.
15916981|NCT03520101|Procedure|TAVI_ViV procedure with CoreValve system|The TAVR procedure will be performed following the standards of each participating center. No restriction or specific recommendation will be given regarding the approach, general vs. local anesthesia, imaging guidance during the TAVI procedure, and post-procedural TAVI management. A 23mm valve will be recommended in all patients randomized to the self-expanding CoreValve Evolut R system.
15916982|NCT03520088|Procedure|Inferior mesenteric Vein dissection|Dissection of the Inferior mesenteric Vein first, and go down to the Artery during the total mesorectal excision
15916983|NCT03520088|Procedure|Inferior mesenteric Artery dissection|Dissection of the Inferior mesenteric Artery directly in the total mesorectal excision
15916984|NCT03520075|Drug|ASTX029|Described above
15916985|NCT03520062|Drug|Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml|Treatment with Liraglutide (3.0mg per day) for ~6 weeks
15916986|NCT03520049|Drug|Oseltamivir|
15916987|NCT03520049|Drug|Placebo|
15916988|NCT03520036|Drug|MT-7117 low dose|MT-7117 low dose QD, oral, 16 weeks
15916989|NCT03520036|Drug|MT-7117 high dose|MT-7117 high dose QD, oral, 16 weeks
15916990|NCT03520036|Drug|Placebo|Placebo QD, oral, 16 weeks
15916991|NCT03520023|Other|Palliative Care Consult|Consult of hospital palliative care service for those meeting study inclusion criteria
15916992|NCT03520010|Behavioral|Externally-facilitated implementation|NHs randomized to the externally-facilitated arm will attend the same kickoff meetings and have access to the same online resources as the control arm but will also be assigned a clinical coach and will have the opportunity to participate in a series of hosted peer-to-peer learning opportunities. The clinical coach will meet regularly with NH staff to guide the facility through implementation of the Wisconsin UTI Improvement Toolkit.
15916993|NCT03520010|Behavioral|Internally-driven implementation|Study NHs randomized to the control arm will participate in kickoff meetings introducing the different UTI toolkit components. The meeting will also cover topics on how to assemble a change team, how to use the different tools in the UTI toolkit, and how to track process and outcome measures to monitor progress. NHs assigned to the control arm will have access to a web-based data tracking tool that will allow them to trend a number of study outcomes (e.g., number of monthly urine cultures and UTI treatment events) in their facility over time. Instructions and educational tools will be made available as an online resource but otherwise NHs in the control arm will be expected to implement the Wisconsin UTI Improvement Toolkit using existing internal resources.
15916994|NCT03519997|Drug|Pembrolizumab|Pembroluzumab 200mg IV once every 3 weeks
15916995|NCT03519997|Drug|Bavituximab|Bavituximab 3mg/kg IV weekly
15916996|NCT03519984|Drug|Cytarabine|Given IV
15916997|NCT03519984|Other|Laboratory Biomarker Analysis|Correlative studies
15916998|NCT03519984|Biological|Recombinant EphB4-HSA Fusion Protein|Given IV
15916999|NCT03519984|Drug|Vincristine Liposomal|Given IV
15917000|NCT03519971|Drug|Durvalumab|Durvalumab IV (intravenous infusion)
15917001|NCT03519971|Other|Placebo|Placebo IV (intravenous infusion)
15917002|NCT03519971|Drug|Cisplatin/ Etoposide|Cisplatin/ Etoposide, as per standard of care
15917003|NCT03519971|Drug|Carboplatin/ Paclitaxel|Carboplatin /Paclitaxel, as per standard of care
15917004|NCT03519971|Drug|Pemetrexed/ Cisplatin|Pemetrexed / Cisplatin, as per standard of care
15917007|NCT03519958|Diagnostic Test|Plasma-tissue testing|EGFR T790M mutation plasma-tissue testing in NSCLC patients who progressed on previous EGFR TKI
15917009|NCT03519932|Device|comfilcon A toric lens|Contact lens
15917010|NCT03519932|Device|samfilcon A toric lens|Contact lens
15917011|NCT03519919|Device|somofilcon A multifocal lens|contact lens
15917012|NCT03519906|Drug|Metoprolol|Patients are tested for their normal prescription metaprolol medication
15917013|NCT03519893|Drug|Losartan|Patients are tested for their normal prescription losartan medication
15917014|NCT03519880|Device|Custom Mask Interface|Subjects enrolled in the study will received a custom designed, 3D printed, non-invasive ventilation mask interface.
15917015|NCT03519867|Drug|MK-8616|MK-8616 will be administered at doses of 0.5, 1.0, 2.0, 4.0 and 8.0 mg/kg iv as a 30-second infusion. Doses are based on actual body weight.
15917016|NCT03519867|Drug|Zemuron®|Zemuron® (0.6 or 1.2 mg/kg, iv) will be administered as a 10-second bolus infusion to achieve 1 to 2 PTCs. If needed, a maintenance dose of 0.15 mg/kg will be given. Doses are based on actual body weight.
15917017|NCT03519854|Drug|Placebo|0.9% NaCl administered as a fast IV bolus dose (within 30 seconds).
15917018|NCT03519854|Drug|Sugammadex|Sugammadex administered as a fast IV bolus dose (within 30 seconds), dosed according to participant actual body weight.
15917019|NCT03519854|Drug|Esmeron®|Esmeron® administered at 0.6 mg/kg as a fast IV bolus (within 10 seconds), dosed according to participant actual body weight.
15917020|NCT03519841|Device|P0.1|Investigational Medical Device collecting spectral Raman data from tissue.
15917021|NCT03519828|Other|No intervention has been conducted|It is an observational study, and no intervention has been conducted
15917022|NCT03519815|Device|Ectoin® Eye Spray - Colloidal|eye spray to be applied to the closed eye lid
15917023|NCT03519815|Device|Liposomal eye spray Tears Again®|eye spray to be applied to the closed eye lid
15917024|NCT03519776|Diagnostic Test|Progesterone variation|The potential gain for medical caretakers and patients would be a certainty if the progesterone level is affected by variations during daytime
15917025|NCT03519763|Diagnostic Test|ultrasound|All the patients will have a transvaginal ultrasound evaluation during the first visit to the clinic to evaluate the presence or not of isthmocele.
15917026|NCT03519750|Drug|Melatonin 25 mg|24-48 hour monitoring of plasma melatonin as well as adverse events.
15917027|NCT03519737|Device|tPA in combination with the Sonolysis Headframe (TUS)|tPA: 60 minutes per approved labeling TUS insonation via the Sonolysis Headframe: minimum 90 minutes - maximum 120 minutes
15917028|NCT03519737|Device|tPA in combination with the Sonolysis Headframe (Sham TUS)|tPA per approved labeling Sham (inactive) TUS insonation via the Sonolysis Headframe: minimum 90 minutes - maximum 120 minutes
15917029|NCT03519724|Drug|Sugammadex|Reversal of deep NMB
15917030|NCT03519724|Drug|Neostigmine|Reversal of moderate NMB
15917031|NCT03519711|Drug|CNSA-001|CNSA-001 will be administered per dose and schedule specified in arms.
15917032|NCT03519698|Other|Warm water|Footbaths were prepared with 12 liters of warm water (40 °C)
15917033|NCT03519698|Other|Mustard|12 l footbath with warm water (40 °C) and 80 g mustard flour (Sinapis nigrea semen plv.)
15917034|NCT03519698|Other|Ginger|12 l footbath with warm water (40 °C) and 80 g ginger flour (Zingiberis rhizoma plv.)
15917035|NCT03519685|Behavioral|Contraceptive Training and Education|Staff at the student health center and local health centers where they refer for contraceptive services will receive a CME-accredited education and training session and technical assistance. The one-day session emphasizes evidence-based and patient-centered contraceptive counseling and provision. Students attending colleges assigned to the intervention arm will receive materials and resources designed to educate young people about contraceptive methods and where to access services.
15917036|NCT03519685|Behavioral|Placebo Nutrition Education|Students attending colleges assigned to the nutrition education arm will receive materials and resources designed to educate young people about the impacts of sugar on health.
15917037|NCT03519672|Other|No intervention|This is a non-interventional study.
15917038|NCT03519659|Diagnostic Test|PET/CT scan with 13 mCi radiation dose|13 mCi 18F-FDG dose
15917039|NCT03519659|Diagnostic Test|PET/CT scan with 5 mCi radiation dose|5 mCi 18F-FDG dose
15917040|NCT03519659|Diagnostic Test|PET/CT scan with 2.5 mCi radiation dose|2.5 mCi 18F-FDG dose
15917041|NCT03519659|Diagnostic Test|PET/CT Scan with 6.5 mCi radiation dose|6.5 mCi 18F-FDG dose
15917042|NCT03519659|Diagnostic Test|PET/CT Scan with not yet determined radiation dose|We plan for the possibility that one of the three-Sub-Studies (A-B) would not demonstrate equivalency, and we would then perform a modified protocol in which the SOC dosing is compared to a lower and higher dose than originally tested.
15917043|NCT03519646|Drug|Eliglustat|"This is a 3-year study and the enrollment time of this study is 24 months.
~The participants have to receive the investigational agent, Cerdelga
~The participants have to go back to the hospital and receive the investigational agent and take the test before receving Cerdelga, and 2 weeks, 1, 3, 6, 12, 18 and 24 months after receiving Cerdelga.
~IMP Administration Method: Cerdelga have 21 mg、42 mg and 84 mg capsule.
~No need for fasting before use, but can't take with grapefruit juice.
~Five ml Blood and 10 ml urine shoud be taken before receiving Cerdelga, and 1, 3, 6, 12, 18 and 24 months after receiving Cerdelga for Gaucher related biomarkers test."
15917044|NCT03519633|Drug|Sugammadex|Reversal of deep NMB
15917045|NCT03519633|Drug|Neostigmine|Reversal of moderate NMB
15917046|NCT03519620|Other|SWWSV|Behaviours to prevent child obesity
15917047|NCT03519607|Behavioral|FertiStrong App|The FertiStrong mobile app is similar to FertiCalm, which is designed for women with infertility. FertiCalm (www.FertiCalm.com) can be downloaded for free anywhere in the US, for both Apple and Android phones. Each app contains twelve main categories and each main category contains up to five tailored situations. For each situation, there are six options. Three of the options are the same for all situations (humor, self-nurture, relaxation) and three are unique (cognitive solutions, behavioral solutions, social solutions).
15917048|NCT03519581|Device|Micropulse Laser Treatment|Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. Application of micropulse laser on retinal surface will occur using TxCell Scanning Delivery System in a 7 x 7 grid to surround the fovea.
15917049|NCT03519581|Device|Sham Treatment|Participant's study eye will be dilated prior to being comfortably seated at the slit lamp for treatment. No actual laser treatment will occur.
15917050|NCT03519568|Biological|EV71 (inoculation vaccine)|EV71 vaccine 0.5ml per dose, Wuhan Biological Products Co., Ltd., Wuhan, Hubei Province, China 10μg HepB 0.5ml per dose, Wuhan Biological Products Co., Ltd., Wuhan, Hubei Province, China 30ug MPSV-A 0.5ml per dose, Wuhan Biological Products Co., Ltd., Wuhan, Hubei Province, China MR 0.5ml per dose, Beijiing Biological Products Co., Ltd., Beijing, China JE-L 0.5ml per dose, Chengdu Biological Products Co., Ltd., Chengdu,Sichuan Province, China
15917051|NCT03519542|Drug|Sunitinib|Identify prognosis and predictive biomarkers of response to sunitinib and pazopanib as first line therapy in avanced or metastatic renal cell carcinoma.
15917052|NCT03519516|Drug|PRO-174|"Pharmaceutical form: ophthalmic solution
~Prepared by: Laboratorios Sophia, S.A. of C.V.
~Description of the solution: transparent solution, free of visible particles.
~Description of container: sterile multi-dose bottle"
15917053|NCT03519516|Drug|Sophixín Ofteno®|"Active substance: Ciprofloxacin 0.3%
~Pharmaceutical form: Ophthalmic solution
~Prepared by: Laboratorios Sophia, S.A. of C.V.
~Description of the solution: transparent solution, free of visible particles.
~Description of container: sterile multi-dose bottle"
15917054|NCT03519490|Device|Hybrid Contact Lens|Hybrid Single Vision or Multifocal Contact Lenses in Near Center and Distance Center Designs
15917055|NCT03519477|Diagnostic Test|Sano Patient Medication Profile|The Sano Patient Medication Profile (PMP) is a graphical report comparing prescribed medications to liquid (chromatography/tandem mass-spectrometry) LC/MS/MS-detected drugs from patient blood samples
15917056|NCT03519464|Biological|Gardasil 9|Gardasil 9 administered as a 0.5ml intramuscular injection in the deltoid region of the upper arm or in the anterolateral area of the thigh, 3-dose regimen of injections given at month 0, month 2, and month 6.
15917057|NCT03519451|Other|Internet-Based Intervention|Given KickAsh smartphone mobile application
15917058|NCT03519451|Other|Internet-Based Intervention|Given Breathe2Relax smartphone mobile application
15917059|NCT03519451|Other|Questionnaire Administration|Ancillary studies
15917060|NCT03519438|Other|Mepitel|Mepitel film will be placed on 3/4 of treatment field to protect from radiation dermatitis
15917061|NCT03519425|Other|Optimised HIV screening and linkage to care|As described in group descriptions
15917062|NCT03519425|Other|Optimised tuberculosis screening and linkage to care|As described in group descriptions
15917063|NCT03519412|Drug|temozolomide (induction),|temozolomide is administered to MGMT promoter methylation-positive MMRp patients orally, once daily, at the dose of 150-200 mg/m2/day for 5 consecutive days of each treatment cycle A treatment cycle will comprise 5 days of temozolomide administration (Day 1 to 5) followed by 23 days of rest for a total of 28 days (4 weeks) period (dose-schedule: 150 mg/m2 day 1-5 q28),until disease progression or unacceptable toxicity whichever comes first.
15917064|NCT03519412|Biological|pembrolizumab (treatment)|pembrolizumab is administered to MGMT-IHC-negative, MGMT promoter methylation-positive MMRp patients with TMB>20 Mut/Mb after Temozolomide treatment, and to MMRd. Patients receive pembrolizumab IV , 200 mg Q3W, Day 1 of each 3 week cycle for maximum 35 cycles, until disease progression or unacceptable toxicity whichever comes first.
15917065|NCT03519399|Device|Monica AN24|Monica AN24 will be used to record maternal and fetal ECGs. The Zephyr will be used to determine maternal lie.
15917066|NCT03519386|Combination Product|G2TR intraocular implant containing travoprost|Provided in Arm/Group descriptions.
15917067|NCT03519386|Drug|Sham surgery + active-comparator eye drops|Sham surgery plus postoperative active-comparator eye drops (timolol maleate ophthalmic solution, 0.5%).
15917068|NCT03519373|Biological|TDaP|Tetanus, Diphteria and Acellular Pertussis vaccine (Boostrix)
15917069|NCT03519360|Other|UFR-restricted dialysis|UFR's are limited to a maximum of 10 mL/kg/hr for the duration of the session. In order to prevent progressive volume overload and the need for additional hemodialysis sessions to manage volume gains in this scenario, subjects will crossover weekly between the restricted and unrestricted UFR interventions.
15917070|NCT03519360|Other|UFR-unrestricted dialysis|UFR's will be unlimited and prescribed according to the standard of care.
15917071|NCT03519347|Other|Potassium Removal Maximization|This intervention will test whether prioritizing lower potassium dialysate to reduce the incidence of hyperkalemia reduces the incidence of clinically significant arrhythmias compared to an approach minimizing intradialytic fall in serum potassium by using higher potassium dialysates to minimize serum-dialysate potassium gradients. This will be achieved by utilizing an algorithm which couples point-of-care-testing with the choice of one of two dialysate potassium concentrations (2 or 3 mEq/L) that are widely available in dialysis clinics.
15917072|NCT03519347|Other|Potassium Gradient Minimization|This intervention will test whether minimizing intradialytic fall in serum potassium by using higher potassium dialysates to minimize serum-dialysate potassium gradients reduces the incidence of clinically significant arrhythmias compared to an approach prioritizing lower potassium dialysate to reduce the incidence of hyperkalemia. This will be achieved by utilizing an algorithm which couples point-of-care-testing with the choice of one of two dialysate potassium concentrations (2 or 3 mEq/L) that are widely available in dialysis clinics.
15917073|NCT03519347|Other|Alkalosis Avoidance|The bicarbonate (HCO3) concentration will be adjusted according to the results of point of care testing of serum chemistries and an algorithm prioritizing alkalosis avoidance by use of lower dialysate HCO3 concentrations.
15917074|NCT03519347|Other|Acidosis avoidance|The bicarbonate (HCO3) concentration will be adjusted according to the results of point of care testing of serum chemistries and an algorithm prioritizing acidosis avoidance by use of higher dialysate HCO3 concentrations.
15917075|NCT03519321|Device|MID-C|The MID-C system is being connected to the spine via standard unilateral posterior approach. Pedicle screws above and below the main curve are being used to attach the device to the selected vertebra.
15917076|NCT03519308|Drug|Nivolumab|Before Surgery Wks 1 &3, After Surgery Wks 1 &3
15917077|NCT03519308|Drug|Nab-Paclitaxel|Wks 1,2,3 before surgery and Wks 1, 2,3 after surgery
15917078|NCT03519308|Drug|Gemcitabine|Wks 1,2,3 before surgery and Wks 1,2,3 after surgery
15917079|NCT03519308|Drug|Paricalcitol|Wks 1,2,3, 4 before surgery and Wks 1,2,3 after surgery
15917080|NCT03519295|Drug|MPDL3280A|MPDL3280A (atezolizumab) will be administered every 2 weeks at 800 mg for 12 months.
15947930|NCT03279978|Drug|BI 730357|up to 28 days
15917081|NCT03519295|Drug|mDCF|Patients will receive 8 cycles of mDCF (docetaxel 40 mg/m2 day 1, cisplatin 40 mg/m2 day 1 and 5FU at 1200 mg/m2/day for 2 days) every 2 weeks
15917082|NCT03519282|Device|comfilcon A multifocal toric lens|contact lens
15917083|NCT03519282|Device|omafilcon A Multifocal Toric Lens|contact lens
15917084|NCT03519269|Device|Navio™ Robotics-assisted Surgical System|Intervention will evaluate the utility of robotic-assistance in patients undergoing total knee arthroplasty
15917085|NCT03519256|Biological|Nivolumab|Specified dose on specified day
15917086|NCT03519256|Biological|BCG|Specified dose on specified day
15917087|NCT03519256|Drug|BMS-986205|Specified dose on specified day
15917088|NCT03519243|Biological|BCD-131|subcutaneously monthly
15917089|NCT03519243|Biological|Mircera|subcutaneously monthly
15917090|NCT03519230|Drug|Pamiparib capsule|60 mg twice daily (BID), orally (per os-PO)
15917091|NCT03519230|Drug|Placebo capsule|60mg BID, PO
15917092|NCT03519204|Device|JUVÉDERM® VOLBELLA® XC with Lidocaine|JUVÉDERM® VOLBELLA® XC with lidocaine injected into lips.
15917093|NCT03519204|Other|No-treatment Control|No-treatment was administered.
15917094|NCT03519191|Behavioral|Healthy Relationships Education (HRE)|Healthy Relationships and Economic Pathways involves formal classes in Healthy Relationship Education (HRE), comprehensive case management, and support services and referrals to services.
15917095|NCT03519191|Behavioral|HRE+Technology Bootcamp|HRE + Technology Bootcamp involves formal classes in Healthy Relationships Education (HRE), comprehensive case management, support services and referral to services, 6-week intensive website and professional development training, and paid work experience developing a website for a local small business and mentorship.
15917099|NCT03519165|Device|EV1000(FloTrac System 4.0)|
15917100|NCT03519152|Drug|low dose diclofenac|it is a split mouth design in which one side recieved low dose diclofenac(25mg) after periodontal flap surgery and in next week second side will recieve diclofenac 50mg after flap surgery.
15917101|NCT03519139|Other|individual dietary counselling|individual dietary counsellings with the aim to ensure sufficient coverage of energy and protein needs of the test subjects
15917102|NCT03519126|Other|electrostimulation|Electrostimulation with asymmetric and depolarized biphasic current with a frequency of 10Hz and a pulse width of 200μs.
15917103|NCT03519113|Biological|GC1102 80,000 IU|recombinant human hepatitis B immunoglobulin
15917104|NCT03519113|Biological|GC1102 100,000 IU|recombinant human hepatitis B immunoglobulin
15917105|NCT03519113|Biological|I.V HBIG|human anti-hepatitis B Immunoglobulin
15917106|NCT03519100|Other|quality of life evaluation|quality of life evaluation post surgery
15917107|NCT03519087|Other|Interdisciplinary Evaluation for Nonarthritic Hip Disease|The hip arthroscopist will conduct his or her standard-care evaluation including subjective interview, patient history, imaging, and physical examination. The physical therapist will conduct an assessment of posture and movement during sitting, standing, squatting, and walking. After providers discuss their findings, they will discuss the plan of care with the participant.
15917108|NCT03519087|Other|Posture and Movement Training|Physical therapists will lead participants through an intervention protocol to normalize seated and standing posture and function movement. Verbal, visual, and tactile cues, along with strengthening exercises will be provided to train posture and movement.
15917109|NCT03519087|Other|Treatment-of-choice|Participants may proceed with any treatment-of-choice, which may or may not have been recommended by their health care provider(s). Treatments will be recorded, but not controlled.
15917110|NCT03519074|Drug|TS-1 combined with cisplatin|Cisplatin 60mg/m2, day 1, every 21 days Oral TS-1 30mg/m2 bd, days 1-14, every 21 days (absolute dose of oral TS-1 will be 40-60mg bd days 1-14, every 21 days, depending on body surface area)
15917111|NCT03519061|Drug|Budesonide|Nasal saline irrigations with budesonide
15917112|NCT03519048|Procedure|Nasofibroscopy|every 1-3 months first year post-treatment, every 2-4 months second year, every 4-6 months third year (mean of around 13 visits) and every 6 months thereafter
15917113|NCT03519048|Other|Low Dose Chest CTscan|every year in patients with tobacco consumption history of > 20 pack-year
15917114|NCT03519048|Other|injected CT-scan|the first performed 12 months after inclusion
15917115|NCT03519048|Other|whole body PET-CT|annual whole body PET-CT (the first at 6 months after inclusion)
15917116|NCT03519048|Procedure|Lugol upper gastrointestinal endoscopy|the first performed 12 months after inclusion
15917117|NCT03519048|Procedure|Biopsy|In both arm, patient will have a confirmation biopsy in case of suspicion of relapse or second primary.
15917118|NCT03519035|Other|To pass different questionnaires|Patients will have to pass different questionnaires (DIB-R, DES II, THQ, PCL-S, PSAS, qualitative questionnaire) in order to compare the characteristics between BDL patients with and without hallucinations.
15917119|NCT03519022|Drug|Cocaine|The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and duloxetine.
15917120|NCT03519022|Drug|Placebo oral capsule|The pharmacodynamic effects of placebo will be determined during maintenance on placebo and duloxetine.
15917121|NCT03519022|Drug|Methylphenidate|The pharmacodynamic effects of methylphenidate maintenance will be determined during maintenance on placebo and duloxetine.
15917122|NCT03519009|Behavioral|IPS Plus Abstinence-Contingent Wage Supplement|Participants are offered abstinence-contingent wage supplements if they obtain and maintain competitive employment. The wage supplements are designed to promote employment while reinforcing drug abstinence. To help participants obtain and maintain competitive employment, participants will receive Individual Placement and Support (IPS) supported employment. IPS is a supported employment intervention that has been proven effective in promoting employment in adults with severe mental illness. To promote employment and prevent relapse to drug use, participants will receive IPS Plus Abstinence-Contingent Wage Supplements.
15917123|NCT03518996|Device|rTMS/iTBS/tACS|Subjects with delirium and matched-controls will be receive theta frequency stimulation of the cerebellum. We will target the cerebellar vermis.
15917188|NCT03518411|Other|Cognitive Behavioral Therapy|One-Session Unified Protocol
15917124|NCT03518996|Device|Sham TMS/tACS|Subjects with delirium and matched-controls will be receive sham stimulation of the cerebellum. We will target the cerebellar vermis.
15917125|NCT03518983|Device|Dornier Aries2 device|The Dornier Aries2 device and will be used for the purpose of the study. LI-ESWT will be applied to the penile shaft and the 2 crura(two sites).
15917126|NCT03518983|Device|Dornier Aries2 device (sham probe)|The Dornier Aries2 device and will be used for the purpose of the study but the active probe will be replaced by an identical sham probe.
15917127|NCT03518970|Other|Nursing intervention|"The intervention was built on the components of the theory of uncertainty in illness and was designed to give in a face to face meeting with the caregiver education about advanced cancer in palliative care through an educational material.
~Educational material: The educational booklet has the purpose of giving information to the family caregiver about palliative care. This material aims to be an easily accessible resource to understand the palliative care of the cancer patient. In addition, this booklet will be used to ensure the standardization of the intervention during the face-to-face meeting with the participants and the investigator.
~Face-to-face meeting: The nursing intervention has a face-to-face meeting component between the investigator and the participant. This nursing educational session will be supported by the contents of the booklet and will have the purpose of discussing the contents of the booklet and resolving doubts on the part of the family caregivers."
15917128|NCT03518957|Behavioral|Exercise|"Week 1: Patients will undergo an introductory session where the occupational therapist will assess the general condition and physical fitness of the subjects.
~Week 1 to Week 12: Group exercise sessions supervised by a physiotherapist, twice per week, each session lasting 1 hour, with no more than 8 participants in each group exercise session. The exercise regimen for each session will be personally tailored for the subjects, and will include stretching, cardiovascular and strength training, and cooling down exercises.
~Week 12 onwards: Patients will receive phone calls- monthly for the first 6 months and then 3 monthly up to the 2-year mark, to encourage them to continue with their exercise regimen at home."
15917129|NCT03518931|Diagnostic Test|Fitness testing|The intervention in this study was measuring cardiorespiratory fitness and muscular strength and providing normative data to subjects.
15917130|NCT03518905|Device|Radiofrequency ablation|Radiofrequency ablation is performed using the Barrx Channel endoscopic catheter (Medtronic, Dublin, Republic of Ireland) generating an energy density level of 12 Joule/cm2. The energy is applied using a simplified protocol of three ablations without removal of coagulated tissue. The device is used on a routinely basis all around the world and already approved. The ablation catheter is applied through the working channel of the endoscope.
15917131|NCT03518905|Procedure|esophagoscopy|Patients receive an esophagoscopy without radiofrequency ablation under sedation
15917132|NCT03518892|Diagnostic Test|Resting Metabolic Rate|30 minute test to determine daily caloric needs
15917133|NCT03518892|Diagnostic Test|Body Composition|Total Body DXA scan to determine fat mass, fat-free mass, and percent body fat
15917134|NCT03518892|Behavioral|Dietary Assessment|Self administered dietary logs
15917135|NCT03518879|Other|ASTHMA-Educator mobile application|The on-site delivered ASTHMA-Educator mobile application.
15917136|NCT03518853|Radiation|Short-course Hypofractionated Once-weekly Radiation Therapy|Eligible patients will be treated with a radiation regimen of 35 Gy in 5 fractions delivered at one fraction per week at 7 day intervals. The dose of radiotherapy is based on the consensus alpha beta ratio of 1.5.
15917137|NCT03518840|Device|SIJ Belt|Support Belts
15917138|NCT03518827|Other|Asymmetry measurement|There is no intervention, the study will prospectively assess associations between asymmetries and injury risk. Asymmetry measurement will be conducted, then injuries will be tracked.
15917139|NCT03518814|Other|Questionnaires|FACT-M (Functional Assessment of Cancer Therapy - Melanoma) questionnaire, MOS SF (medical outcome study short form) -36 questionnaire
15917140|NCT03518801|Behavioral|Prolonged Exposure|psychotherapy
15917141|NCT03518801|Drug|Cannabidiol|active medication
15917142|NCT03518801|Drug|placebo|non-active medication
15917143|NCT03518788|Procedure|Pleur-X|Permanent drainage
15917144|NCT03518788|Procedure|Pleurodesis|Pleurodesis with talc in permanent VATS
15917145|NCT03518775|Device|Biometry|Measurement of Cornea
15917146|NCT03518762|Procedure|Sustained lung inflation (SLI)|SLI was given using a peak pressure of 20 cm H₂O sustained for 15 seconds,using a T-piece resuscitator, Neopuff device
15917147|NCT03518762|Procedure|Continuous positive airway pressure (CPAP)|CPAP through an appropriate mask using a pressure 5 cm H₂O,using a T-piece resuscitator, Neopuff device.
15917148|NCT03518749|Other|1mA tDCS|transcranial direct current stimulation with the intensity of 1mA
15917149|NCT03518749|Other|2mA tDCS|transcranial direct current stimulation with the intensity of 2mA
15917150|NCT03518749|Behavioral|Cognitive control training|cognitive control training with the PASAT
15917151|NCT03518736|Behavioral|Supporting Play Exploration and Developmental Intervention (SPEEDI)|Physical Therapy intervention
15917152|NCT03518723|Other|Non-linear Periodized Resistance Training|8 week non-linear periodized resistance training intervention, 3 sessions per week, 60 minutes per session
15917153|NCT03518723|Other|Resistance training|8 week resistance training intervention, 3 sessions per week, 60 minutes per session
15917154|NCT03518710|Other|Neuropsychological evaluation|"Neuropsychological evaluation (about 60 min) the same day realized by a student in Science Thesis under the responsibility of Prof. Yves Chaix and including:
~Process evaluation:
~Oculomotors: DEM test (5min)
~Visuo-attention: computerized STROOP (15min)
~Visuo-Perceptive: DTVP3 (30min)
~Phonological & lexical: Exalang (10min)"
15917155|NCT03518710|Other|Evaluation of the reading assistance technique|"Evaluation of the reading assistance technique (about 30 min) and comprising:
~- Reading evaluation:Test lark (3min) Experimental task: 3-way help with reading (without help, color help and highlight help (25 min)"
15917156|NCT03518697|Behavioral|exercise program|"The exercise program is planned as a low-threshold exercise program with low barriers to participate. Patients will be asked about their interests and preferences of sports activities to conceive the exercise program together with the patients."
15917189|NCT03518398|Device|Intense Pulsed Light|E> Eye (E-SWIN, Paris, France) IPL machine
15917190|NCT03518398|Combination Product|Standard treatment|warm compression, lid scrub and non-preservative ocular lubricants
15947931|NCT03279978|Drug|Placebo|up to 28 days
15917157|NCT03518684|Drug|Natalis|"A specially-designed sterile obstetric gel (Natalis) will be used for this trial. The obstetric gel is a birth gel with no pharmacologic effects that has a purely physical activity. It contains propylene glycol, glycerol, sodium chloride, xanthan gum, hydroxyethylcellulose and water.
~Starting with the first vaginal examination the obstetric gel will be used. After each vaginal examination, 3-5 mL of obstetric gel will be introduced into the vaginal birth canal in the area in front of the child using the sterile obstetric gel applicator without any manipulation or massaging. Additional obstetric gel will be added 15-30 minutes after rupture of the membranesOnce the head of the child is visible, the mouth and nose region will be wiped clean. A dry towel will be used to liberate the child in order to prevent the child from slipping"
15917158|NCT03518671|Behavioral|cognitive behavioral therapy, face to face|self-limited cognitive behavioral therapy delivered weekly for 5 weeks via face-face delivery method
15917159|NCT03518671|Behavioral|cognitive behavioral therapy, telemedicine|self-limited cognitive behavioral therapy delivered weekly for 5 weeks via tablet-based telemedicine platform
15917160|NCT03518658|Other|Evaluation Group|Patient receiving exposure to the MyCareLink Heart App during device pairing
15917161|NCT03518658|Other|Control Group (Historical)|Patients receiving exposure to the CareLink Monitor 2490 (Excluding wireless model 2490C). The patients' data will be extracted from Medtronic de-identified CareLink™ database.
15917162|NCT03518645|Device|OPN strategy|Predilatation with OPN balloon will be performed as a lesion preparation for BVS Absorb implantation.
15917163|NCT03518645|Device|standard strategy|Predilatation with standard balloon will be performed as a lesion preparation for BVS Absorb implantation.
15917164|NCT03518632|Behavioral|Interval training|Patients in experimental group will perform a 6 weeks' physical activity program with 3 sessions per week. Physical activity intervention will consist in 2 different interval training programs on cycloergometer: Interval training 1 and Interval training 2, with a difference in exercise intensities.
15917165|NCT03518632|Other|Standard Oncologic care|Patients in control group will follow the standard oncologic care. They will perform only 2 sub-maximal exercises.
15917166|NCT03518619|Behavioral|PFIcope+EMI|The intervention will be comprised of (1) an initial orientation session where the intervention is introduced, receipt of personalized normative information, motives feedback, and the development of an individual's personalized relapse prevention coping skills messages to be utilized through the course of the intervention; (2) EMA for monitoring of affect, drinking intention, alcohol use, and coping skills use; (3) EMI-tailored text messages sent based on EMA responses: individualized, self-chosen relapse prevention coping skills messages when participants report negative affect and intent to drink.
15917167|NCT03518606|Drug|Durvalumab + Tremelimumab + metronomic Vinorelbine|Patient will be treated by metronomic oral vinorelbine associated with durvalumab + tremelimumab combination immunotherapy
15917168|NCT03518593|Other|Cash and counselling|Additional 500 Ksh per child per month and household visits by Community health Volunteers (CHVs)
15917169|NCT03518580|Other|real-time assessment of biopsychosocial functioning|the participants were asked to provide biopsychosocial data using the mobile device
15917170|NCT03518567|Drug|Smoked marijuana cigarettes: High THC dose (6% THC)|Smoked marijuana cigarettes (High THC dose [6% THC])
15917171|NCT03518554|Drug|JAB-3068|JAB-3068 will be orally administered on a daily basis. Patients need to fast 2 hours before （6 hours for PK days) and 2 hours after each dosing.
15917172|NCT03518541|Procedure|Femoral Derotation Osteotomy (FDO)|Correction of malrotation of the femoral bone by osteotomy, derotation and osteosynthesis
15917173|NCT03518528|Drug|Estradiol 2 MG|Vaginal estradiol (Provames, Sanofi) 4mg per day from day 3 to first pregnancy test. If pregnancy test is positive, treatment is to continue until 8 weeks
15917174|NCT03518528|Drug|Estradiol 100 µg|transdermal estradiol (Vivelledot, Novartis) 100 µg on day 3, then 200 µg day 7 and every 4 days, until first pregnancy test. If pregnancy test is positive, treatment is to continue until 8 weeks.
15917175|NCT03518515|Other|White potato (french fries)|If randomized to this group, participants will be asked to consume 1 serving of French fries (~300 kcal) each day for 30 days as a part of their usual dietary intake. French fries will be portioned and provided to participants.
15917176|NCT03518515|Other|White potato (French fries), +seasoning|If randomized to this group, participants will be asked to consume 1 serving of French fries (~300 kcal) with added potential glycemia modifying seasoning mix each day for 30 days as a part of their usual dietary intake. French fries and seasoning will be portioned and provided to participants.
15917177|NCT03518515|Other|Almond|If randomized to this group, participants will be asked to consume 1 serving of almonds that is calorically-matched to the French fries (~300 kcal) serving in the other arms each day for 30 days as a part of their usual dietary intake. Almonds will be portioned and provided to participants.
15917178|NCT03518502|Procedure|transarterial chemoembolization (TACE)|Standard therapy for intermediate HCC, but nor for advanced HCC
15917179|NCT03518502|Drug|Sorafenib|Standard therapy for advanced HCC
15917180|NCT03518489|Drug|Lappaconitine Adhesive Patch|to evaluate the efficacy of lappaconitine adhesive patch in alleviation radiation induced mucositis pain
15917181|NCT03518489|Drug|standard care|Standard care will include mouth wash with antibiotics.
15917182|NCT03518476|Behavioral|intensive multi-disciplinary education program on tobacco treatment for pharmacists|Participants in the intervention group will participate in an intensive education program delivered by a multi-disciplinary group of educators, researchers, and clinicians with expertise in tobacco control and tobacco dependence treatment. The program will be delivered over 4 days (run over 2 weekends) with an average of eight contact hours per day (a total of 32 contact hours) at Qatar University.
15917183|NCT03518476|Other|Control arm|Participants in control arm will receive a non-tobacco related training or educational session
15917184|NCT03518463|Combination Product|Enhanced recovery after surgery (ERAS)|The ERAS arm was exposed to standard preoperative, intraoperative and postoperative ERAS protocols of care. However, some were modified to our local resources and requirements as well as to the emergency nature of the surgeries.
15917185|NCT03518450|Procedure|Apex Femoral Triangle Block|Nerve block that aims the vastus medialis nerve, the saphenous nerve and the anterior femoral cutaneous nerve.
15917186|NCT03518450|Procedure|Femoral Nerve Block|Regional anesthetic technique that blocks the sensory and motor information of the femoral nerve (and it's branches).
15917191|NCT03518385|Diagnostic Test|ultrasound,transvaginal scan|The presence of fluid in the uterine cavity during hormonal stimulation.
15917194|NCT03518346|Behavioral|Virtual Reality|Samsung VR Go (VR head set), Samsung S7 (phone), and programmed distraction
15917195|NCT03518346|Behavioral|Standard of Care|Books, movies, TV
15917196|NCT03518333|Device|Injection of adipose derived cells into penis|Injection of Icellator-derived cells
15917197|NCT03518320|Drug|Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200|TAR-200 will be placed in the bladder through an inserter and gradually release gemcitabine for four consecutive 21-day dosing cycles for a total period of approximately 84 days
15917198|NCT03518320|Drug|Nivolumab Injection [Opdivo]|Nivolumab will be given intravenously on specified days for four consecutive 21-day dosing cycles for a total period of approximately 84 days
15917199|NCT03518294|Behavioral|Aerobic Exercise|Subjects in the aerobic exercise group will be supervised to exercise 30 minutes, 5 times per week at a moderate intensity. Formal exercise instruction and supervision will be provided by ACSM certified fitness professionals at the Penn State University Fitness Center. Aerobic exercise can be completed on either the treadmill, exercise bike, rowing machine or the elliptical machine.
15917200|NCT03518281|Dietary Supplement|Whole Cell Euglena containing Beta Glucan|Whole Cell Euglena containing >50% Beta Glucan
15917201|NCT03518281|Dietary Supplement|Placebo|microcrystalline cellulose, hypromellose, titanium dioxide, water
15917202|NCT03518268|Drug|Vivomixx|The intervention consists of 2 sachets a day containing the probiotic Vivomixx, for 6 months
15917203|NCT03518268|Drug|Placebo|The intervention consists of 2 sachets a day of placebo, for 6 months
15917204|NCT03518255|Other|Nature video|After signing the Informed Consent Form, the participants will respond to a demographic questionnaire to characterize the sample and then they will watch nature videos. After that, will be applied a scale questionnaire about the physical and psychological symptoms of chemotherapy in the positive and negative mood of that patient.
15917205|NCT03518242|Drug|Cyclophosphamide|Given PO
15917206|NCT03518242|Drug|Methotrexate|Given PO
15917207|NCT03518242|Drug|Capecitabine|Given PO
15917208|NCT03518242|Procedure|Biospecimen Collection|Undergo biospecimen collection
15917209|NCT03518229|Device|Microsoft Band 2 + UV messaging|wearable device (wrist) and associated mobile application; UV sensor and messaging activated
15917210|NCT03518229|Device|Microsoft Band 2|wearable device (wrist) and associated mobile application; UV messaging not activated
15917211|NCT03518216|Behavioral|ADAPT|Aim to Decrease Anxiety and Pain Treatment is a remotely delivered tailored treatment integrating mindfulness meditation and cognitive behavioral therapy. It consists of 6 sessions and blends pain and anxiety coping strategies. The first 2 sessions will be interactive with a trained psychological provider and the following 4 sessions will be web-based. Each web-based session will be followed by therapist support. The intervention is delivered through a HIPAA compliant video platform.
15917212|NCT03518203|Drug|Eculizumab|Eculizumab will be administered as intravenous infusion (IV) over 60 minutes. The dosage form will be 300 mg single-use vials each containing 30 mL of 10 mg/mL sterile, preservative-free solution.
15917213|NCT03518190|Device|Infrared spectroscopy (ODP)|Infrared spectroscopy device will be used to detect non-visible pressure injuries
15917214|NCT03518177|Other|Hospital-based pulmonary rehabilitation|The patient will receive an 8-week Pulmonary Rehabilitation Exercise Program including breathing exercises, treadmill walking, cycle ergometer, arm ergometer training and strengthening trainning with free weights at hospital.
15917215|NCT03518177|Other|Home-based pulmonary rehabilitation|The patient will receive an 8-week Pulmonary Rehabilitation Exercise Program including breathing exercises, free-walking, and strengthening training with free weights at home
15917216|NCT03518164|Procedure|Allograft|Bone graft
15917217|NCT03518151|Other|Product placement intervention|The intervention includes 3 components: i) creation of a new fresh fruit and vegetable section and island in the first aisle; ii) placing frozen fruit and vegetables in the first aisle and iii) removal of all cakes, confectionary and sugar sweetened beverages from checkouts (replaced with non-food items, fruit and bottled water).
15917218|NCT03518151|Other|Sham comparator|The control condition is provision of a limited range of fresh fruit and vegetables, all placed at the back of the store, frozen vegetables in a middle aisle and confectionery sold at checkouts.
15917219|NCT03518138|Drug|Q-122|oral capsule of Q-122
15917220|NCT03518138|Drug|Placebo|oral capsule of placebo
15917221|NCT03518125|Biological|BioThrax|"Other Names:
~Anthrax Vaccine Adsorbed (AVA)"
15917222|NCT03518125|Biological|AV7909|Anthrax Vaccine Absorbed plus CPG 7909 Adjuvant
15917223|NCT03518125|Drug|Sodium chloride injection USP, 0.9% (placebo)|"Other Names:
~Saline Solution"
15917224|NCT03518112|Biological|Blinatumomab|Given IV
15917225|NCT03518112|Drug|Cyclophosphamide|Given IV
15917226|NCT03518112|Drug|Cytarabine|Given IT or IV
15917227|NCT03518112|Drug|Dexamethasone|PO or IV
15917228|NCT03518112|Biological|Filgrastim|Given SC
15917229|NCT03518112|Other|Laboratory Biomarker Analysis|Correlative studies
15917236|NCT03518099|Biological|blood sampling|Two tubes of 5ml of blood will be collected for Serum collection, 3 tubes of 5 ml of blood taken for plasma collection and 2 tubes of 7 ml of blood taken for DNA collection
15917241|NCT03518060|Drug|Juluca|Juluca is a combination of dolutegravir (INSTI) and rilpivirine (NNRTI).
15917242|NCT03518047|Drug|risankizumab|rizankizumab subcutaneous (SC) infusion
15917243|NCT03518047|Drug|placebo for rizankizumab|placebo for rizankizumab subcutaneous (SC) infusion
15917244|NCT03518034|Drug|Testosterone|It will be administered topically.
15917245|NCT03518034|Drug|Placebo|A matching placebo to testosterone will be administered topically.
15917246|NCT03518021|Drug|Naloxone, intranasal|"Active compound naloxone 14 mg/ml, (±10%). Nasal spray will be administered with one puff (100 microL ±10%) in one nostril (1.4 mg dose) using the Aptar Unitdose device.
~The spray device should be inserted about 1 cm into a nostril, pointing towards the ipsilateral ear and the plunger pushed in a firm and gentle manner for the formulation to be sprayed into the nose. After the plunger is inserted the device is immediately removed from the nose and assisted ventilation continued."
15917247|NCT03518021|Drug|placebo, intranasal|"Same spray but without naloxone. Nasal spray will be administered with one puff (100 microL +/- 10%) in one nostril using the Aptar Unitdose device.
~The spray device should be inserted about 1 cm into a nostril, pointing towards the ipsilateral ear and the plunger pushed in a firm and gentle manner for the formulation to be sprayed into the nose. After the plunger is inserted the device is immediately removed from the nose and assisted ventilation continued."
15917248|NCT03518021|Drug|Naloxone, intramuscular|Intramuscular comparator Naloxone Hydrochloride 0.4 mg/ml will be administered as a 2 ml intramuscular (IM) injection in the deltoid muscle, total dose of 0,8 mg naloxone IM
15917249|NCT03518021|Drug|placebo, intramuscular|Intramuscular Sodium Chloride Injection 9mg/ml, will be administered as a 2 ml intramuscular injection in the deltoid muscle
15917250|NCT03518008|Device|verofilcon A contact lenses|Investigational daily disposable soft contact lenses
15917251|NCT03518008|Device|somofilcon A contact lenses|Commercially available daily disposable soft contact lenses
15917252|NCT03517995|Drug|Sulforaphane Administration|1 capsule (10 mg Prostaphane) taken two times per day (2 capsules, 20 mg Prostaphane total).
15917253|NCT03517995|Other|Placebo Administration|1 capsule (placebo) taken two times per day (2 capsules total).
15917254|NCT03517995|Procedure|Standard of Care Surgery|The study will be conducted during the time from when participants are diagnosed with bladder cancer to when they undergo a surgical procedure for the treatment or removal of their bladder cancer. The surgical procedure is done as a part of their regular medical care.
15917255|NCT03517982|Drug|Mycophenolate Mofetil|Film Coated Tablet, each tablet contains 500mg Mycophenolate Mofetil
15917256|NCT03517969|Drug|Berzosertib|Given IV
15917257|NCT03517969|Drug|Carboplatin|Given IV
15917258|NCT03517969|Drug|Docetaxel|Given IV
15917259|NCT03517969|Other|Laboratory Biomarker Analysis|Correlative studies
15917260|NCT03517956|Drug|Rogaratinib (BAY1163877)|"Dose escalation:
~Starting dose is rogaratinib 400 mg twice daily (b.i.d.) in continuous 28-day cycles from Cycle 1 Day 3 onwards.
~Dose expansion:
~With dose identified in dose escalation part."
15917261|NCT03517956|Drug|Copanlisib (BAY80-6946)|"Dose escalation:
~Starting dose is 45 mg on Days 1, 8 and 15 of each 28-day cycle.
~Dose expansion:
~With dose identified in dose escalation part."
15917262|NCT03517943|Drug|Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-SAG)|Oral, Loratadine 5 mg/ pseudoephedrine sulfate 120 mg (x1)
15917263|NCT03517943|Drug|Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-Heist)|Oral, Loratadine 5 mg/ pseudoephedrine sulfate 120 mg (x1)
15917264|NCT03517930|Drug|Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-SAG)|Oral, Loratadine 5 mg/ pseudoephedrine sulfate 120 mg (x1)
15917265|NCT03517930|Drug|Loratadine + Pseudoephedrine sulfate (Claritin-D, BAY818725) (Manufacturer-Heist)|Oral, Loratadine 5 mg/ pseudoephedrine sulfate 120 mg (x1)
15917266|NCT03517917|Other|Tumour tissue collection|Collection of tumour tissue and blood
15917267|NCT03517904|Procedure|IVUS-guided angioplasty|Angioplasty using drug-coated balloon (DCB) will be performed in standard manner. IVUS evaluation will be performed before predilation and after DEB treatment. In cases of stent implantation, additional IVUS evaluation will be performed after stenting. All lesions will be predilated using a plain balloon with a diameter 1 mm smaller than vessel size. Selection of DCB diameter will be chosen on the basis of IVUS measurement. Implantation of stents will be left to the operator's decision after reviewing IVUS findings after the DCB treatment. Generally, in presence of ≥ 50% residual stenosis or flow limiting dissections, implantation of stents is recommended.
15917268|NCT03517904|Procedure|Angiography-guided angioplasty|Angioplasty using drug-coated balloon (DCB) will be performed in standard manner. All lesions will be predilated using a plain balloon with a diameter 1 mm smaller than vessel size. Selection of DCB diameter will be chosen on the basis of angiogram. Implantation of stents will be left to the operator's decision after reviewing the angiogram after the DCB treatment. Generally, in presence of ≥ 50% residual stenosis or flow limiting dissections, implantation of stents is recommended.
15917269|NCT03517891|Behavioral|WIC+|"intervention was based on the Health Self-Empowerment Theory. It will be adapted for the web-based platform using the Persuasive Technology and Persuasive System Design models. These models focus on the human-computer interface and how technology can/is used as a persuasive tool for behavior change. We will also include Bandura's Social Cognitive Theory.
~The intervention will be delivered through the combination of:
~educational modules provided through an interactive distance learning platform designed to provide learning experiences using multiple modalities; short messaging platforms to promote adoption of healthy behaviors and use of the educational platform; one to one sessions with the interventionist over the telephone."
15917297|NCT03517670|Other|Milrinone efficiency on cerebral vasospasm|It will be assessed using ultrasound measurements of middle cerebral arteries velocities. A decrease of at least 20% of the mean velocity or of the Lindegaard index will be considered as a significant positive effect of the treatment (including milrinone).
15917321|NCT03517540|Drug|Cenicriviroc (CVC)|Comparison with monotherapy and different combination doses
15917270|NCT03517878|Behavioral|Comprehensive CHW Program|"The comprehensive CHW Cohort will receive home visits from CHWs recruited, trained, and supervised by the Philani organization. Philani has a 30-year history of non-stigmatizing home-based support for women and children in Cape Town. The organization has been operating their comprehensive CHW program in the rural Eastern Cape since 2010; however, in the research areas, CHWs have only been active for one year prior to initiation of the study. Philani recruits CHWs that are positive peer deviants to serve as role models in the community. The CHWs then receive training, materials, and skills to address major community health challenges of HIV, TB, malnutrition, alcohol use, and depression. The CHWs also receive ongoing monitoring and supervision as well as support for difficult cases."
15917271|NCT03517852|Device|Human Intravital Microscopy|Intravital microscopy (IVM) allows real-time, direct visualization of microscopic blood vessels and calculation of blood flow.
15917272|NCT03517839|Other|Inspiratory muscle trainig|Inspiratory muscle training in the training group will be administered at least 5 days a week, 15 minutes twice a day, beginning at 30% of the MIP for 8 weeks. Patients will come to the control once a week, the MIP values will be re-measured and the new training intensity will be determined at 30% of the new value. For the control group, a fixed training session will be given for at least 5 days a week, 15 minutes twice a day, not exceeding 15% of the MIP for 8 weeks.
15917273|NCT03517813|Device|Contrast-enhanced Spectral Mammography (CESM)|Dual energy mammography images obtained after the administration of an intravenous contrast agent
15917274|NCT03517800|Other|Arterial embolization and/or surgical management.|Arterial embolization and/or surgical management.
15917275|NCT03517787|Other|FES+TE|Group receive FES+therapeutic exercise during 6 weeks (twice a week). Altogether 8 exercises are conducted, each done 3 sets and 12 repetitions during first three weeks and 4 sets during last three weeks of intervention).
15917276|NCT03517787|Other|TE|Group perform only therapeutic exercise. Exercises are the same between all 4 groups.
15917277|NCT03517787|Other|REF-FES+TE|Group perform FES+TE, but only participate in 1 session to collect reference data.
15917278|NCT03517787|Other|REF-TE|Group perform only therapeutic exercise, but only participate in 1 session to collect reference data.
15917279|NCT03517774|Device|3D Printed Socket|Twenty participants will be fitted with a 3D Printed socket created using 3DPrintAbility hardware and software. To do this, a 3D model of the participants residual limb will be generated which will be used to create the 3D printed sockets. These 20 participants will also receive standard care for prosthetic fitting at SJR. The fittings will be done by one prosthetist. Our team will compare the feasibility, function, quality and stability of the prosthetics through quantitative, economic and qualitative analyses. All fittings will be done under the supervision of a qualified Sunnybrook prosthetist who has previous experience with using 3D printed technologies for creation of prosthetics.
15917280|NCT03517761|Biological|Bone Marrow Concentrate treatment|While under unconscious TIVA anesthesia, the injectate is then injected under fluoroscopy into the area in need of treatment using an anterior approach through the posterior oropharynx with direct visualization of the injection site via endoscopy. The alar, transverse, and accessory ligaments are the target areas to be treated with the bone marrow concentrate injectate. Patients will be repositioned in the prone position to then receive upper cervical injections to C0-C3 ligaments and facets.Patients will receive 2 of these treatment procedures 3 months apart.
15917281|NCT03517761|Other|Sham Control|Control subjects will receive a sham procedure of a small skin puncture to the posterior oropharynx guided under fluoroscopy while under anesthesia.Patients will also receive small skin punctures to the back of the neck to mimic ligament and facet injections. Patients will receive 2 of these procedure 3 months apart.
15917282|NCT03517748|Device|DM05 eye drops|Ophthalmic use. One to two drops instilled in each eye from 4 to 6 times per day during 84 days of treatment.
15917283|NCT03517748|Device|Optive™ eye drops|Ophthalmic use. One to two drops instilled in each eye from 4 to 6 times per day during 84 days of treatment.
15917284|NCT03517735|Device|EasyTiva (algorithm is the property of Medsteer SAS)|Propofol and Remifentanil are administered automatically using a closed-loop system. Bispectral index is used as the input signal and an algorithm defines the appropriate concentrations of propofol and remifentanil. Adequate postoperative sedation is defined by a bispectral index between 55 and 75.
15917285|NCT03517735|Drug|Propofol|The dosage is modified automatically by the device or according to the new medical prescription.
15917286|NCT03517735|Drug|Remifentanil|The dosage is modified automatically by the device or according to the new medical prescription.
15917287|NCT03517722|Drug|Placebo|Participants will receive placebo matching to ustekinumab IV or SC.
15917288|NCT03517722|Drug|Ustekinumab (approximately 6 mg/kg)|Participants will receive ustekinumab approximately 6 mg/kg via IV route based on body weight-range.
15917289|NCT03517722|Drug|Ustekinumab 90 mg|Participants will receive 90 mg ustekinumab via SC route.
15917290|NCT03517709|Other|Primary Care Physician Management of blood pressure|"You will receive a 30-minute education session about your blood pressure medications and the need to take them every day.
~Your primary care physician will make recommendations on your optimal target blood pressure range and medication recommendations. ."
15917291|NCT03517709|Device|Withings Smart Blood Pressure Monitor|We will use the Withings Smart Blood Pressure Monitor for daily blood pressure measurements.
15917292|NCT03517696|Procedure|Membrane sweeping|Participants assigned to membrane sweeping will have an additional exam during their initial evaluation in which the membranes will be separated from the cervix and lower part of the uterus with a finger inserted into the cervical os. This would be done with at least one rotation counterclockwise and one rotation clockwise.
15917293|NCT03517683|Other|Low speed|Speed of intrathecal injection will be 1ml in 15 seconds
15917294|NCT03517683|Other|High speed|speed of intrathecal injection will be 1ml in 5 seconds
15917295|NCT03517670|Other|Rhythmic tolerance|Rhythmic intolerance is defined by the occurrence of arrhythmia prompting the initiation of an antiarrhythmic medication and the need to decrease or even to stop the infusion of milrinone
15917296|NCT03517670|Other|Hematological tolerance|Hematological tolerance will be considered good if milrinone infusion was not interrupted owing to the occurrence of thrombocytopenia
15917318|NCT03517566|Drug|ZPL389 50mg|ZPL389 50 mg oral powder; once daily from baseline to week 16
15917319|NCT03517553|Device|EMS users in ESRD|use of passive electrical muscle stimulation on quadriceps muscle 3 times a week for patients in dialysis
15917298|NCT03517670|Other|Milrinone efficiency using the modified Rankin scale|Scored as follows: 0 = No symptoms, 1 = No significant disability. Able to perform all usual activities, despite certain symptoms, 2= Slight disability. Able to take care of his own affairs without assistance, but unable to carry out all previous activities, 3 = Moderate disability. Requires some help, but able to walk unassisted, 4 = Moderate severe disability. Unable to meet their own physical needs without help and unable to walk without help, 5 Severe disability. Needs constant care and attention, bedridden, incontinent, 6 = Death.
15917299|NCT03517657|Behavioral|Bilateral Motor Priming + Task Specific Training (BMP + TST)|"Priming will always precede task specific training. During bilateral motor priming, the Rocker (Exsurgo Bilateral Primer, Aukland, New Zealand) will be used. For the individuals assigned to the bilateral priming group, both hands will be strapped in place in the vertically oriented plates which are attached via a mechanical linkage. They will move both wrists in rhythmic, symmetrical wrist flexion and extension for 15 minutes at a frequency of 1 Hz as cued by a metranome. Subjects do not need to have active flexion and extension of the affected hand as the less affected arm drives the weaker one (through an acutator underneath the surface) in in-phase bilateral symmetrical movement."
15917300|NCT03517657|Behavioral|Control Priming + TST (CP + TST)|The control priming intervention for the active comparator group will be intermittent cutaneous electric stimulation of the volar aspect of the paretic forearm, using a standard TENS unit delivered for 15 seconds (including 2-second ramp-up, 2-second ramp-down), once per minute, for 15 minutes. Intensity will be minimized
15917301|NCT03517644|Other|DP|Participants are informed that they are about to receive an effective analgesic cream. They are instructed to apply the cream using a cotton pad.
15917302|NCT03517644|Other|OLP Hope|Participants are informed that they are about to receive an placebo cream. They are told that the cream has no active pharmacological ingredient. Therefore, participants are supposed to evaluate the subjective probability for a positive effect of the cream as rather low. However, using verbal instructions, the investigator aims to induce hope among the participants that the cream could have a positive effect for them because this placebo cream did have a positive among some former participants who were similar to the current participant. The emphasis of this similarity (regarding age and sex) aims to induce a feeling of connectedness to previous participants who reported positive effects of the placebo cream.
15917303|NCT03517644|Other|OLP Expectation|Participants are informed that they are about to receive an placebo cream. They are told that the cream has no active pharmacological ingredient. However, participants are told that placebos have been shown to contribute substantially to clinical outcomes such as pain intensity/unpleasantness. This positive effect of placebos is reasoned by explaining learning mechanisms such as classical conditioning. We anticipated that after hearing this instruction, participants would consider it to be likely that the placebo has a positive effect for them.
15917304|NCT03517644|Other|Placebo cream|The participants receive an inert placebo cream (standard basic cream with oil of thyme produced by a local pharmacy).
15917305|NCT03517644|Other|Heat pain|Participant receive heat pain stimuli using the suprathreshold method of the Thermo Sensory Analyser (TSA-II), a commonly used device to study pain sensation and analgesic effects.
15917306|NCT03517631|Biological|shRNA-modified CD34+ cells|Infusion of CD34+ cells transduced with shRNAs.
15917307|NCT03517631|Drug|Low dose busulfan preconditioning|A single dose of 1 mg/kg busulfan administered every 6 hours for 4 times as preconditioning for transplantation.
15917308|NCT03517631|Drug|Busulfan preconditioning|A single dose of 1 mg/kg busulfan administered every 6 hours for 8 times as preconditioning for transplantation.
15917309|NCT03517618|Drug|S-1+leucovorin|"Eligible patients will receive TS-1 orally 40-60 mg (depending on patient's body surface area (BSA)) in combination with calcium folinate 30 mg twice a day for 7 days in a 2-week cycle.
~The treatment will be administered until disease progression, intolerable toxicity, or consent withdrawal during any time of the study."
15917310|NCT03517605|Other|Exercise for cardiac rehabilitation|An exercise program was designed according to the American College of Sports Medicine and performed by the Specialist Nurses in Rehabilitation Nursing. Comprises aerobic and recovery/stretching. Started in the intensive care unit after the 24 hours post-surgery, and later, during hospitalization. Clinical data (Blood Pressure, Heart Rate, Peripheral Oxygen Saturation) and Borg scale will be recorded in the initial, intermediate and final periods of each session. Capillary glycemia will be evaluated at the beginning of each session. Three sessions of exercises will be performed weekly with duration of 30 min to 60 min, divided in heating (10-25 min), aerobic exercise (10 min) and recovery (10-25min). Possible symptoms will be controlled during exercise sessions.
15917311|NCT03517592|Other|EMDR|The EMDR SUD Protocol consists of a detailed interview with respect to traumatic events, the treatment of those with the EMDR standard protocol and a further specific protocol for SUD that is focused on the concept of addiction memory.
15917312|NCT03517592|Other|Treatment as Usual|The TAU condition includes follow-up visits with the psychiatry, psychology and with the nursing service. Visits with the psychiatrist consist to evaluate clinical status and readjust the pharmacological treatment if necessary while visits with the psychologist consist to assess and detect risk situations and to prevent relapses using a cognitive behavioral approach. Finally, the nursing service will provide health and care habits and will carry out the abstinence controls.
15917313|NCT03517579|Device|Cervical Collar Therapy Indicator (COTI)|"Study Device; The CoTI has 3 components;
~A collar unit: a gamma detector wrapped around a body part-neck in this case and contains a scintillating crystal and a silicon photomultiplier. The photon pulse signal is then converted to digital signals (measuring the counts per second). Usually two detectors are placed in specified positions.
~A cable that connects the collar unit to the Control Unit
~A control unit that collects the signals and transmits it wirelessly to a hand-held computer tablet.
~Two types of collar devices will be used: the lower activity and the medium activity
~Lower activity collar for patients with Graves' disease as well as diagnostic I-123 scan in thyroid cancer patients. These patients typically receive 0.2-1.2 m Ci of I-123/I-131.
~Medium activity collar for Patients with thyroid cancer after 131-I ablation, for which patients typically receive 30-100 mci of I-131."
15917314|NCT03517566|Drug|Placebo|once daily from baseline until week 16
15917315|NCT03517566|Drug|ZPL389 3mg|ZPL389 3 mg oral powder; once daily from baseline to week 16
15917316|NCT03517566|Drug|ZPL389 10mg|ZPL389 10 mg oral powder; once daily from baseline to week 16
15917317|NCT03517566|Drug|ZPL389 30mg|ZPL389 30 mg oral powder; once daily from baseline to week 16
15917322|NCT03517527|Behavioral|Exercise|
15917323|NCT03517514|Other|Physical Therapy service|routine physical therapy care
15917324|NCT03517501|Drug|ART-123|Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days
15917325|NCT03517501|Drug|Placebo Comparator - Placebo|Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days
15917326|NCT03517488|Biological|XmAb20717|Monoclonal bispecific antibody
15917327|NCT03517475|Behavioral|SHS Low-Income|An intervention to train caregivers to supervise their children appropriately.
15917328|NCT03517462|Drug|Ivermectin 3Mg Tab|ivermectin tablet
15917329|NCT03517449|Drug|Pembrolizumab|200 mg administered by IV infusion on Day 1 of each 21-day cycle.
15917330|NCT03517449|Drug|Lenvatinib|20 mg administered orally (PO) QD during each 21-day cycle.
15917331|NCT03517449|Drug|Paclitaxel|80 mg/m^2 administered by IV on a 28-day cycle: 3 weeks receiving paclitaxel once a week and 1 week not receiving paclitaxel.
15917332|NCT03517449|Drug|Doxorubicin|60 mg/m^2 administered by IV on Day 1 of each 21-day cycle.
15917333|NCT03517436|Device|TAVR with CENTERA THV|TAVR with the Edwards CENTERA THV System
15917334|NCT03517423|Drug|Brivaracetam|An antiepileptic drug whose putative mechanism of action is as a result of direct inhibition of SV2A receptors, responsible for the successful release of excitatory neurotransmitters from the the neuronal presynaptic membrane.
15917335|NCT03517410|Other|Smart phone use|Patients will be asked to use the smart phone while seated for either: (1) 10 minutes or (2) 30 minutes.
15917336|NCT03517397|Behavioral|Mobile Contingency Management|Participants will be offered 6 counseling sessions, nicotine replacement therapy, and a smartphone app that remotely verifies participant identity and smoking abstinence and automatically credits a gift card account for evidence of smoking abstinence.
15917337|NCT03517384|Behavioral|I-CBT for Body Dysmorphic Disorder|The current intervention, is a therapist guided, Internet Cognitive Behavioral Therapy treatment for Body Dysmporhic Disorder which consists of 8 treatment modules administered over the course of 12 weeks.
15917338|NCT03517371|Other|mHealth delivered exercise program|"Participants in the mobile health condition have up to 10 in-person visits with a physical therapist over 12 months. The exercise program, consisting of walking, strengthening and stretching exercises, is prescribed through an app and remotely adapted by a physical therapist over 1 year. Approximately 5-7 exercises are implemented 5 days per week."
15917339|NCT03517371|Other|Exercise only|Participants in the control group have up to 10 in-person visits with the intervention physical therapist over 12-months. Participants are instructed by the physical therapist to engage in walking and perform progressive resistance and stretching exercises (tailored to their needs and provided in written format) 5 days per week.
15917340|NCT03517358|Other|Service of care|Subjects will be receiving care from case management or clinical pharmacy.
15917341|NCT03517345|Dietary Supplement|Prebiotic|Prebiotic (Inulin+Oligofructose) consumed as 10 g/d in yogurt (200 g/d)
15917342|NCT03517345|Dietary Supplement|Control|The only yogurt consumed as 200 g/d without prebiotic.
15917343|NCT03517319|Drug|Normal Saline 0.9% 1.2 ml|
15917344|NCT03517319|Drug|Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 15 U|
15917345|NCT03517319|Drug|Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 30 U|
15917346|NCT03517319|Drug|Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 50 U|
15917347|NCT03517319|Drug|Clostridium Botulinum Toxin Type A (Nabota, DWP 450) 70 U|
15917348|NCT03517306|Other|No Interventions|No Interventions
15917349|NCT03517293|Behavioral|Aerobic Exercise training|
15917350|NCT03517267|Diagnostic Test|ultrasound and FNA|The nodule to undergo FNA will be chosen according to TIRADS ACR criteria and the ATA risk criteria ( if there is a disagreement between the methods whether to perform FNA the FNA will be performed ) If both methods do not recommend FNA , but the referring doctor has requested the procedure or the patient is unable to stay on follow up , the FNA will be performed .
15917351|NCT03517254|Dietary Supplement|Glutamine|At the beginning and at the end of the training session, the experimental group will receive by mouth 15 grams of glutamine dissolved in 120 milliliters of water. The aminoacid will be inside gray envelopes.
15917352|NCT03517254|Other|Strength training program|One training session consists of 20 minutes of warm-up, 40 to 60 minutes of aerobic and anaerobic exercises and 15 minutes of cooling down. The exercises of the lower part of the body consist in 3 sets of 10 repetitions for healthy knee, and 12 repetitions for knee with anterior cruciate ligament reconstruction in a modular leg press, leg curl and leg extension machine.
15917353|NCT03517254|Other|Placebo|Maltodextrin powder to mimic glutamine,
15917354|NCT03517254|Other|Dietary recommendations|All participants, irrespective of the supplement that they receive, will be closely monitored by a nutritionist, who will give dietary recommendations to standardize protein consumption (1.2 gr/kg weight). Status nutritional will be assessed according to BMI ( 19.9-24.9, 25-29.9).
15917355|NCT03517241|Diagnostic Test|functional magnetic resonance imaging (fMRI)|Retinotopic mapping using functional magnetic resonance imaging (fMRI) is based on MR images acquired with blood-oxygenation-level-dependent (BOLD) contrast to reveal areas of neuronal activity in the visual cortex
15917356|NCT03517241|Diagnostic Test|Microperimetry (MP)|MP allows localized testing of retinal sensitivity of foveal, parafoveal and even more peripheral macular regions
15917357|NCT03517241|Diagnostic Test|Optical coherence tomography (OCT)|Optical Coherence Tomography (OCT) is a non-invasive diagnostic technique that renders an in vivo cross sectional view of the retina.
15917358|NCT03517241|Diagnostic Test|Blue light fundus autofluorescence imaging (FAF)|Fundus autofluorescence imaging (FAF), is a non-invasive diagnostic technique focusing on the fluorescent properties of pigments in the retina to generate images.
15917359|NCT03517241|Diagnostic Test|Visual testing|Best-corrected visual acuity will be measured using Early Treatment Diabetic Retinopathy Study (ETDRS) charts. Reading acuity and reading speed will be examined using Radner Reading Charts. Reading acuity is measured in logRAD unit (= reading equivalent of logMAR) and in critical font size (critical reading size), reading speed is measured in words per minute (wpm). Contrast sensitivity will be determined using Pelli-Robson contrast sensitivity charts.
15917430|NCT03516721|Other|the prevalence of chronotropic incompetence CI during maximal cardiopulmonary exercise testing, CPET|
15917360|NCT03517228|Device|BAUM device|The robotic manipulator will be placed at the start of each case. The manipulator will be cleaned and sanitized using the same process as other reusable OR devices. Feasibility will be determined by the rate of successful robotic manipulator docking and if the manipulation of the uterus was successful for the duration of the procedure. The V-Care is an FDA approved uterine manipulator which will attach to the investigational BAUM. Placement of a BAUM will be noted on the operative note.
15917361|NCT03517215|Behavioral|Enhanced CB-ASP|The education session will be a 1-hour on site presentation that will cover antimicrobial resistance, antimicrobial stewardship, an introduction to effective primary care interventions for reducing antibiotic prescribing, and a review of the clinic's baseline audit of antimicrobial prescribing for the prior year. E-Modules will be completed online and audit and feedback sessions will be held in person to give an overview of each clinic's prescribing numbers.
15917362|NCT03517215|Behavioral|Standard CB-ASP|A one hour introductory educational seminar will be offered to prescribers via a web-link. They will be provided with access to e-modules each month by email and sent their audit and feedback reports by email.
15917363|NCT03517189|Procedure|Aorta no-touch|Participants will be submitted to aorta no-touch off-pump coronary artery bypass surgery.
15917364|NCT03517176|Drug|CEND-1|CEND-1 will be provided as concentrate for solution to be administered via IV injection.
15917365|NCT03517176|Drug|Nab-paclitaxel|Nab-paclitaxel will be provided as solution to be administered via IV infusion.
15917366|NCT03517176|Drug|Gemcitabine|Gemcitabine will be provided as solution to be administered via IV infusion.
15917367|NCT03517150|Device|mandibular advancement device|
15917368|NCT03517137|Drug|Brentuximab Vedotin|For PET positive (score of 4-5 following Deauville Criteria) patients: Brentuximab vedotin is administered as an IV infusion over a period of 30 minutes at 1.8 mg/kg on day 1, every 3 weeks (6 cycles); For PET negative (score of 1-3 following Deauville Criteria) patients: Brentuximab vedotin is administered as an IV infusion over a period of 30 minutes at 1.2 mg/kg on day 1 and 15, every 4 weeks (5 cycles)
15917369|NCT03517137|Drug|Adriamycin|For PET positive (score of 4-5 following Deauville Criteria) patients: Adriamycin is administered as an IV infusion over a period of 15 minutes at 40 mg/m² on day 2, every 3 weeks (6 cycles); For PET negative (score of 1-3 following Deauville Criteria) patients: Adriamycin is administered as an IV infusion over a period of 15 minutes at 25 mg/m² on day 1 and 15, every 4 weeks (5 cycles)
15917370|NCT03517137|Drug|Vinblastine|For PET negative (score of 1-3 following Deauville Criteria) patients: Vinblastine is administered as an IV infusion over a period of 15 minutes at 6mg/m² on day 1 and 15, every 4 weeks (5 cycles)
15917371|NCT03517137|Drug|Dacarbazine|For PET positive (score of 4-5 following Deauville Criteria) patients: Dacarbazine is administered as an IV infusion over a period of 60 minutes at 250 mg/m² on day 3 and 4, every 3 weeks (6 cycles); For PET negative (score of 1-3 following Deauville Criteria) patients: Dacarbazine is administered as an IV infusion over a period of 60 minutes at 375 mg/m² on day 1 and 15, every 4 weeks (5 cycles)
15917372|NCT03517137|Drug|Etoposide|For PET positive (score of 4-5 following Deauville Criteria) patients: Etoposide is administered as an IV infusion over a period of 60 minutes at 150 mg/m² on day 2,3 and 4, every 3 weeks (6 cycles)
15917373|NCT03517137|Drug|Cyclophosphamide|For PET positive (score of 4-5 following Deauville Criteria) patients: Cyclophosphamide is administered as an IV infusion over a period of 30 minutes at 1250 mg/m² on day 2, every 3 weeks (6 cycles)
15917374|NCT03517137|Radiation|Radiation Therapy|Patients with residual lymphoma mass(es) showing metabolic activity of Deauville score 4 or 5 after completion of chemotherapy will be offered consolidation radiotherapy.
15917375|NCT03517124|Other|Ceramic tooth restoration|Dental restorations
15917376|NCT03517111|Behavioral|Nutrition/substance use prevention|Parenting program focusing on diet improvement and substance use prevention
15917377|NCT03517111|Behavioral|Substance use prevention only|Parenting program focusing only on substance use prevention
15917378|NCT03517111|Behavioral|Academic success program|Program focusing on academic success and college acceptance
15917379|NCT03517098|Procedure|The ERAS group|"ERAS pathway for orthopedic surgeons:
~Shortened preoperative fasting from intake.
~Preoperative tranexamic acid administration.
~No indwelling catheters.
~No tourniquet used for TKA.
~No drainage tube.
~Application of the low molecular heparin 6 hours after the operation.
~ERAS pathway for anesthesiologist:
~Intravenous 20 mg of dexamethasone before anesthetic induction.
~Anesthesia will be induced with small dose of long-acting opioids such as sulfentanil, or without long-acting opioids at all.
~Laryngeal mask for airway.
~Anesthesia will be maintained with short-acting anesthetic agents such as desflurane, sevoflurane, or propofol, with continuous remifentanil , and BIS value will be kept between 40 to 60 during procedure.
~Incision infiltration with 40-50ml of 0.2% ropivacaine, and no patient controlled intravenous analgesia devices will be applied."
15917380|NCT03517098|Procedure|The non-ERAS group|Patients undergoing THA or TKA will receive conventional care according to different participating center, and there's no standard protocol for pre-operative management, anesthetic technique or medication choice, postoperative analgesia or food intake, or catheters indwelling.
15917381|NCT03517085|Genetic|DTX401|DTX401 administered as a single peripheral IV infusion
15917382|NCT03517046|Drug|CartiLife|Biological: CartiLife® Procedure: CartiLife® is beads (1.0 to 1.5 mm in diameter) in suspension, developed from autologous chondrocytes. The beads are implanted in a volume of 1 cm3 per the capacity of the syringe to the affected area through injection with a fibrin adhesive through minimal arthrotomy.
15917383|NCT03517033|Drug|Torrent's Nebivolol Tablets|
15917384|NCT03517033|Drug|Forest Pharmaceuticals Inc.'s Bystolic Tablets|
15917385|NCT03517020|Drug|Torrent's Nebivolol Tablets|
15917386|NCT03517020|Drug|Forest Pharmaceuticals Inc's Bystolic Tablets|
15917387|NCT03517007|Other|Opt-Out Protocol|Should an eligible patient pass the safety screen and be randomized to the intervention arm of the trial, the designated pharmacist will approach the patient's primary provider in charge of antibiotic decision-making The pharmacist will inform the provider the patient's antibiotics can be de-escalated unless the provider opts out.
15917388|NCT03516994|Behavioral|Respecting Choices First Steps|Advance Care Planning Approach
15917389|NCT03516994|Behavioral|Five Wishes Form|Advance Care Planning Approach
15917394|NCT03516968|Drug|Monthly bolus of cholecalciferol per os|Bolus therapy (100'000 - 200'000 IU/month depending on age: < or ≥ 9 years old) for 3 months
15917395|NCT03516968|Drug|Daily dose of cholecalciferol per os|Daily substitution (3'500 to 6'500 IU/day depending on age: < or ≥ 9 years old) for 3 months
15917396|NCT03516968|Other|Control|no cholecalciferol therapy
15917397|NCT03516955|Drug|Rosuvastatin|Superstat ® Tablets 10mg, 20mg
15917398|NCT03516942|Other|Quality-of-Life Assessment|Ancillary studies
15917399|NCT03516942|Other|Questionnaire Administration|Ancillary studies
15917400|NCT03516929|Diagnostic Test|carotid duplex, both LL arterial duplex|assessment of carotid stenosis and lower limb peripheral ischemia.
15917401|NCT03516916|Other|Questionnaires on HRQoL and sociodemography|All patients are asked to answer a panel of questionnaires to test validity and reliability of the Colostomy Impact Score.
15917402|NCT03516903|Drug|Methotrexate|ddMTX-LDE (Methotrexate carried by a lipid nanoemulsion)
15917403|NCT03516903|Drug|Placebo|Placebo-LDE (Lipid nanoemulsion)
15917404|NCT03516903|Drug|Folic Acid|Folic acid pill
15917405|NCT03516890|Procedure|Partial hepatectomy|Partial hepatectomy was comprised of single or multiple liver resections aiming to excise all macroscopic tumors.
15917407|NCT03516864|Device|MIMOSA Imager|The MultIspectral MObile tiSsue Assessment (MIMOSA) Imager acquires digital images to calculate anatomical details of chronic wounds (e.g. diameter, surface area, and perimeter). The device can be worn from a lanyard, and clips onto a smartphone, using natural ambient lighting to capture images of a wound. The MIMOSA also uses up to 6 near-infrared LEDs to illuminate tissue with different wavelengths of light to assess tissue oxygenation.
15917408|NCT03516864|Device|Kent Camera|The Food and Drug Administration (FDA) has previously approved a near-infrared device called the Kent camera for the assessment of tissue oxygenation.
15917409|NCT03516851|Procedure|Precision bypass group|With the brain cortex exposed after craniotomy, an initial ICG fluorescence angiography will be performed. ICG fluorescence angiography using Flow800 software to determine blood flow velocity and cortical perfusion in different candidate receptors. And electromagnetic neuronavigation system is used to evaluate the cerebral flow under different candidate recipient vessels. The treatment planning station will be situated based on the multimodal neuronavigation data. The vessel was chose as the receptor with lower flow velocity and lower cerebral perfusion area to perform anastomosis. Then a direct bypass surgery will be performed just like in the empirical direct bypass surgery group.
15917410|NCT03516838|Drug|ACTIVA™ BioACTIVE|Restorative Dental Material: Permanent resin containing filling dental material with bioactive properties to restore decayed teeth
15917411|NCT03516838|Drug|Compomer|Restorative Dental Material: Permanent resin containing filling dental material to restore decayed teeth
15917412|NCT03516825|Other|Musical Neglect Training|MNT uses musical exercises which are structured in pitch, time and tempo, and musical equipment (tone bars, keyboards, drums) configures to focus attention to the neglect visual field.
15917413|NCT03516812|Other|Laboratory Biomarker Analysis|Correlative studies
15917414|NCT03516812|Drug|Olaparib|Given PO
15917415|NCT03516812|Other|Quality-of-Life Assessment|Ancillary studies
15917416|NCT03516812|Other|Survey Administration|Ancillary studies
15917417|NCT03516812|Drug|Testosterone Enanthate|Given IM
15917418|NCT03516812|Drug|Testosterone Cypionate|Given IM
15917419|NCT03516799|Other|Acupuncture|Acupuncture is a method of Traditional Chinese Medicine that consists of the insertion of thin, sterile, FDA-approved disposable needles on specific acupuncture points (acupoints).
15917420|NCT03516773|Drug|EB612 (EBP05)|Entera Bio's proprietary drug for the administration of PTH(1-34) orally
15917421|NCT03516773|Drug|NATPARA/NATPAR|A PTH replacement (PTH [1-84]; NATPARA (Shire-NPS Pharmaceuticals, Inc., Lexington, Massachusetts) was approved by the United States (US) Food and Drug Administration (FDA) in April 2015 / NATPAR (Shire Pharmaceuticals Ltd., Dublin, Ireland) was approved by the European Medicines Agency in April 2017 for use as an adjunct to calcium and vitamin D to control hypocalcemia in patients with hypoparathyroidism. Like many other hormonally active peptides, PTH (1 84); NATPARA is parenterally administered. In this protocol when a specific formulation is referenced (e.g. NATPARA) it may be read interchanged with the alternate formulation (e.g. NATPAR).
15917422|NCT03516760|Drug|GEM333|infusion of GEM333; administered intravenously and continuously over 10 days
15917423|NCT03516747|Diagnostic Test|pre operative parathyroid hormone level measurement|At the clinic, the participants will undergo ultrasound examination with fine needle aspiration. The aspirated material will be sent for parathyroid hormone level measurement.
15917424|NCT03516747|Diagnostic Test|pre operative parathyroid cytology|At the clinic, the participants will undergo neck ultrasound examination with fine needle aspiration. The aspirated material will be sent for cytology examination.
15917425|NCT03516747|Diagnostic Test|parathyroid hormone level measurement|At surgery, after the pathologic gland is excised , the gland will be aspirated. The material will be sent for parathyroid hormone level measurement.
15917426|NCT03516747|Diagnostic Test|parathyroid cytology|At surgery, after the pathologic gland is excised , it will be aspirated again for cytologic examination.
15917427|NCT03516734|Dietary Supplement|Iron fortified lentils|Lentils will be iron-fortified using NaFeEDTA iron fortificants
15917428|NCT03516734|Other|Non Iron-fortified lentils|Non-fortified lentils will be provided
15917434|NCT03516695|Device|TheraSphere®|Intra-arterial Yttrium-90 glass microspheres
15917435|NCT03516682|Behavioral|Reminders|Automated reminders for the 6 month and 12 month vaccine visits for parents experiencing logistic barriers to vaccination.
15917436|NCT03516669|Drug|Clarithromycin|Twenty patients receive intraluminal clarithromycin eradication of H. pylor.
15917437|NCT03516669|Drug|Amoxicillin, Clarithromycin|Patients fail to achieve intraluminal eradication of H. pylori will be assigned to the oral antibiotic rescue therapies with triple therapy which contains a proton pump inhibitor, amoxicillin and clarithromycin for 14 days.
15917438|NCT03516656|Drug|Standard heparin dose|Patients will be placed on heparin infusions per their surgeon's discretion.
15917439|NCT03516656|Drug|Real time heparin dose adjustment|Patients will have steady state anti-Xa levels drawn at least 6 hours after initiation of heparin infusion. Patients with out of range anti-Xa levels will receive real time heparin dose adjustment followed by repeat anti-Xa levels.
15917440|NCT03516643|Other|Extracorporeal Shockwave Myocardial Revascularization|extracorporeal shockwave in ischemic area evaluated by SPECT
15917441|NCT03516630|Drug|Trazodone 20 mg|Oral drops
15917442|NCT03516630|Drug|Trazodone 60 mg|Oral drops
15917443|NCT03516630|Drug|Trazodone 140 mg|Oral drops
15917444|NCT03516630|Drug|Placebo|Oral drops
15917445|NCT03516630|Drug|Moxifloxacin 400mg|Tablet
15917446|NCT03516617|Drug|Acalabrutinib|Given PO
15917447|NCT03516617|Other|Laboratory Biomarker Analysis|Correlative studies
15917448|NCT03516617|Biological|Obinutuzumab|Given IV
15917449|NCT03516617|Other|Patient Observation|Undergo observation
15917450|NCT03516617|Other|Quality-of-Life Assessment|Ancillary studies
15917451|NCT03516604|Drug|PF-04995274|PF-04995274 tablets
15917452|NCT03516604|Drug|Citalopram|Citalopram capsule
15917453|NCT03516604|Drug|Placebo Oral Tablet|Placebo tablet, identical to PF-04995274 tablet
15917454|NCT03516604|Drug|Placebo oral capsule|Placebo capsule, identical to citalopram capsule
15917455|NCT03516591|Drug|AMV564 14-Day CIV|A 14-Day Continuous Intravenous Infusion regimen
15917456|NCT03516578|Other|Cardiac magnetic resonance imaging|
15917457|NCT03516565|Other|Saliva collection|
15917458|NCT03516565|Other|GCF collection|
15917459|NCT03516539|Device|Group ML|Mcgrath videolaryngoscope
15917460|NCT03516539|Device|Group DL|Macintosh laryngoscope
15917461|NCT03516526|Drug|Natalizumab|Extending dose intervals of natalizumab from 4 weeks to maximum of 8 weeks based on trough natalizumab concentrations
15917462|NCT03516513|Behavioral|Problem Solving Therapy as Usual|Treatment as usual to deliver 6 weekly sessions to teach patients how to use the seven step process to solve problems.
15917463|NCT03516513|Behavioral|Assisted Problem Solving Therapy|Smart note assisted delivery of 6 weekly session to teach patients how to use the seven step process to solve problems
15917464|NCT03516500|Drug|Iron Sucrose Injection|The investigators inject Iron Sucrose (100 mg dissolved in 50 mL saline) into the segmental bronchus.
15917465|NCT03516487|Drug|SYNB1618|SYNB1618 is supplied in a buffered solution in 5 mL polypropylene cryovials with a nominal 5 mL fill volume, administered with 100 mL of masking buffer solution.
15917466|NCT03516487|Drug|Placebo|Subjects receive placebo orally in a chilled buffered solution (100 mL).
15917467|NCT03516474|Device|MIMOSA Diagnostics|"The MIMOSA shines different colours of light on your skin. It will not touch your skin, or change how your wound is healing. The MIMOSA is designed to be used alongside the camera that is built into your cell phone, and we will use a cell phone to take a picture of your skin. This picture will tell us how much oxygen is getting to your wound, which can tell us more about how you are healing. The MIMOSA device is an experimental diagnostic tool, and will not influence how your wound is healing."
15917468|NCT03516461|Procedure|Selective Microbiota Transplantation (SMT)|Selective microbiota transplantation for patients via nasointestinal tube (once per day for 3 days)
15917469|NCT03516461|Procedure|Fecal Microbiota Transplantation (FMT)|Fecal microbiota transplantation for patients via nasointestinal tube or gastroscopy (once per day and no more than 3 times)
15917470|NCT03516448|Drug|Gan Fu Le Tablets|6 Tablets，tid,po
15917471|NCT03516448|Drug|Tyroserleutide for injection|6mg/d, 5days,ivgtt
15917472|NCT03516448|Drug|Placebo|0mg/d, 5days,ivgtt
15917473|NCT03516435|Device|Parasacral transcutaneous electrical stimulation|Asymmetrical biphasic square current pulse Frequency：10 Hz pulse width：1.0 ms Intensity：highest tolerable intensity(≦80 mA.) Parasacral transcutaneous electrical stimulation：Clinic using 2 superficial 3.5 cm electrodes placed on each side of S3 and S4.
15917474|NCT03516435|Device|Intravaginal electrical stimulation|Asymmetrical biphasic square current pulse Frequency：10 Hz pulse width：1.0 ms Intensity：highest tolerable intensity(≦80 mA.) Intravaginal electrical stimulation：The electrode plug for vaginal plug was cylinder-formed with ring-formed placed into vaginal.
15917475|NCT03516422|Procedure|ULTRASOUND DEBRIDEMENT|Low-frequency ultrasound SonicOne O.R. (Misonix, New York, US) generates ultrasound waves with 22.5 kHz frequency. Each probe is attached to a set of irrigation solution (saline 0.9%), they transform electric energy into mechanical vibrations to induce tiny particles of water from irrigation fluid. Absorbent pads are positioned to catch excess saline. With SonicOne set at continuous mode with minimum pump flow, the debridement will begin at most distal aspect of ulcer with the hand piece in constant motion until entire ulcer surface has been debrided until as much necrotic tissue has been removed. Peri-wound skin will be cleansed using gauze and sterile normal saline and dry. Packing material will be applied (Acticoat®) into wound cavity.
15947932|NCT03279978|Drug|Midazolam|Dose groups 4 & 5 only
15917476|NCT03516422|Other|STANDARD CARE GROUP|The subject positioned so absorbent pads are in position to catch irrigation solution. The saline bottle will be held 10-15 cm from wound bed, and squeezed to spray all surfaces of wound in a sweeping motion, from clean to dirty area of wound. Irrigation will be repeated as necessary to remove exudate, slough, and debris from the wound until the solution draining from the wound is clear. Peri-wound skin will be cleansed using gauze and sterile normal saline and dry. Packing material will be applied (Acticoat®) into the wound cavity, undermining, or tunnel to fill the dead space without causing the wound to stretch or bulge or be packed tightly. Packing should be in contact with entire wound base and edges. Dressings changed once every 3 days by the patient's care provider.
15917477|NCT03516409|Dietary Supplement|Biokult|"Bio-Kult Infantis® is a multi-strain formula containing a probiotic formulation comprising 7 strains of probiotics, high content of Omega-3, Vitamin D3 and Preplex® (50% FOS and 50% gum acacia).
~Each sachet contains:
~Minimum 1 billion microorganisms per sachet (1 x 109CFU/g), guaranteed throughout the shelf life
~DHA + EPA: >1mg per sachet
~Vitamin D3: 2.5mcg per sachet (50% of Nutrient Reference Value). Bio-Kult Infantis® presents itself in the form of a white powder, packaged in sachets of 1 g each"
15917478|NCT03516409|Dietary Supplement|Placebo|"IP placebo is manufactured so to contain maltodextrin DE19 and have the same organoleptic properties of the active product (similar to the study product in appearance and taste) but without active ingredient. It contains 100% maltodextrin DE19.
~Moreover, placebo sachets are equal in color, shape and weight (1 g) to IP sachets."
15917479|NCT03516396|Behavioral|Training Plus|Training plus enhanced community development activities
15917480|NCT03516396|Behavioral|Training Only|Training Only (livestock management and child nutrition) for 24 months then add community development inputs
15917481|NCT03516396|Behavioral|No Inputs then Community development and training|No inputs for 24 months then add community development and training
15917482|NCT03516383|Device|PWVi|
15917483|NCT03516370|Drug|Saccharomyces Boulardii 250 MG|all the patient first recived scaling and root planning as a prophylactic mesaure later after that patient received intrapocket delivery of Saccharomyces Boulardii mixture.
15917484|NCT03516344|Procedure|Liver pumping and Spinal manipulation|Interventions are described in group descriptions
15917485|NCT03516331|Drug|FDL176 & FDL169 coadministration|CFTR corrector and potentiator
15917486|NCT03516318|Behavioral|SMART Connections|SMART Connections: Trained facilitators will deliver key informational messages and moderate online group discussions. The informational messages have been developed from key messages identified in each of the Positive Connections curriculum sessions. Each SMART Connections group will consist of approximately 15 to 20 YLHIV. Each online support group will begin with one in-person group meeting with the facilitator. During this meeting, participants meet one another and the facilitators. Facilitators will describe the intervention and set ground rules for participation. Ground rules will be discussed and accepted by the group members, but at a minimum, group members will be advised not to talk about what is discussed in the online group with people outside of the group.
15917487|NCT03516305|Drug|Staccato Alprazolam 1 mg|alprazolam I mg administered via the Staccato hand-held inhaler device system.
15917488|NCT03516292|Diagnostic Test|Urinary Nerve Growth Factor|The subjective patient's discomfort regarding the vaginal prolapse problems and urinary incontinency symptoms will be assessed through the following questionnaires: (a) ICIQ-OAB (b) ICIQ FLUTS (c) ICIQ-VS. Determination of the bladder neck of urethra in midsagittal plane using a transvaginal two-dimensional ultrasound machine at lithotomy position in rest (point OA) and on Valsalva maneuver (point OB). Bladder Neck Mobility is defined as the difference from point OA to OB. BWT is determined and measured as the hypoechoic layer between two hyperechoic layers that is recognized as the urothelium and the perivesical tissue using a transvaginal two-dimensional ultrasound machine at lithotomy position. The measurement is performed with a bladder volume <30 ml and is taken place in 3 different bladder sites: (a) the thickest part of the bladder triangle, (b) the dome of the bladder in the midline, (c) the anterior wall of the bladder. NGF will be measured in urine sample.
15917489|NCT03516279|Drug|Dasatinib|Given PO
15917490|NCT03516279|Drug|Imatinib Mesylate|Given PO
15917491|NCT03516279|Other|Laboratory Biomarker Analysis|Correlative studies
15917492|NCT03516279|Drug|Nilotinib|Given PO
15917493|NCT03516279|Biological|Pembrolizumab|Given IV
15917494|NCT03516253|Dietary Supplement|Fish oil + EPO|Supplementation with both fish oil and EPO
15917495|NCT03516240|Other|Biofreeze|Following a procedure that induces muscle fatigue in the lower extremity, a topical cream will be applied over the quadriceps. The cream will be either a topical analgesic (Biofreeze) or a placebo cream. Evaluation of the movement kinematics and kinetics will be evaluated for each group.
15917496|NCT03516240|Other|Placebo|Following a procedure that induces muscle fatigue in the lower extremity, a topical cream will be applied over the quadriceps. The cream will be either a topical analgesic (Biofreeze) or a placebo cream. Evaluation of the movement kinematics and kinetics will be evaluated for each group. Placebo cream will be blinded to both the experimenter and study participant. It will look and smell the same and will be in the same packaging.
15917497|NCT03516227|Behavioral|heart rate variability biofeedback|The HRVBF group received four, one-on-one bedside biofeedback training sessions (20-minutes a day for 4 days), and practiced on their own (10-minutes twice a day) using a FDA-regulated, hand-held mobile biofeedback device (StressEraser, Helico Inc., New York, NY, USA).26 The control group received usual care.Afterwards, all participants were telephoned bi-weekly and encouraged to practice slow breathing (HRVBF group) or to perform self-care (control group) for three months.
15917498|NCT03516214|Drug|EGF816|Continuous oral treatment (once daily) with the 3rd generation EGFR inhibitor EGF816.
15917499|NCT03516214|Drug|Trametinib|Continuous oral treatment (once daily) with the MEK inhibitor trametinib.
15917500|NCT03516188|Drug|Alginate-antacid group|Participants will be given 10 mL of alginate-antacid preparation (Gaviscon-Advance®, Reckitt-Benckiser, United Kingdom)
15917501|NCT03516188|Drug|Non antacid alginate group|Participants will be given 4 mL of magnesium tri-silicate which has equivalent strength and component with Gaviscon-Advance® except it is alginate-free.
15917502|NCT03516175|Device|High flow transnasal oxygen|High flow nasal oxygen that is Transnasal Humidified Rapid Insufflation Ventilatory Exchange
15917503|NCT03516175|Device|Pre oxygenation using tight fitting facemask|100% oxygen via a tight fitting facemask
15917504|NCT03516162|Other|There is no study-specific intervention|There is no study-specific intervention
15917505|NCT03516149|Other|Foam Rolling Exercise|Foam rolling exercise will be performed actively. Participants will use a foam roller for exercise. They will position the foam roller on the chair. Afterwards, they will use their body weights to rub the elbow area (biceps brachii muscle) with this foam. There will be 2 sets and each set will be 1 minute. Single set contains 10 repetitions in 1 minute with 30 seconds resting period between sets
15917506|NCT03516136|Device|EndoFast Reliant SCP|POP repair procedure with the EndoFast Reliant SCP system
15917507|NCT03516123|Drug|CS3006|"In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme.
~In the dose expansion part, participants will receive CS3006 at specified dose level(s)."
15917508|NCT03516110|Other|Data collection|Subjects will be treated in accordance with usual medical practice during their participation in this study. No additional assessments or tests will be required.
15917509|NCT03516097|Behavioral|Structured school based intervention|Intervention includes behavioral, nutritional and physical activity counselling (online and face-to-face psycho-educative sessions).
15917510|NCT03516097|Device|mobile app usage|The e-therapeutic platform and mobile app (TeenPower) includes educational resources, self-monitoring, social support, interactive training modules and motivational tools. In addition to the case manager, the program will also have the direct support of an interdisciplinary team (nurse, nutritionist, exercise physiologist, psychologist among others).
15917511|NCT03516084|Drug|ZL-2306(nirapairb)|The initial dose is 300mg QD or 200mg QD based on baseline weight and platelet count.
15917512|NCT03516084|Drug|Placebo|The initial dose is 300mg QD or 200mg QD based on baseline weight and platelet count.
15917513|NCT03516071|Drug|Brivanib 800 mg, QD|Brivanib Alaninate 800 mg QD, PO
15917514|NCT03516071|Drug|Brivanib 400 mg, BID|Brivanib Alaninate 400 mg BID, PO
15917515|NCT03516058|Other|Simulation-Based Education|"Participating residents receive lectures on TAP block and the use of ultrasound devices from an expert before training, and then receive simulation-based training for an hour from the anesthesiologist's staff. The residents performed three ultrasound guided TAP blocks using an anesthetized porcine model during the training session.
~The residents filled out a questionnaire before and after the training session. Ten multiple-choice questions tested general knowledge in abdomen ultrasound and TAP block. Subjective comfort levels with ultrasound machine and block device functionality, patient positioning, proper block technique, image documentation, needle safety and overall procedural confidence and anxiety levels were reported on a 5-point Likert scale before and after training."
15917516|NCT03516045|Drug|18F-AlF-NOTA-neurotensin|One injection of the radioligand 18F-AlF-NOTA-neurotensin
15917517|NCT03516032|Behavioral|exercises|
15917518|NCT03516019|Other|personalized notices|The personalized notices take into account if data were received over the previous week, and accordingly encourages the participant to use the device and send her data, or encourages the participant to continue using the device and sending data. A library of personalized notices with alternative motivational content was developed. Each time a notification is sent, it will be drawn at random from the library.
15917519|NCT03516019|Other|standard notices|The standard notices which are neutral and invite participants to wear the watch daily and to measure their blood pressure weekly.
15917520|NCT03516019|Other|am notices|notifications sent at 7 am.
15917521|NCT03516019|Other|pm notices|notifications sent at 7 pm.
15917522|NCT03516019|Other|weekday notices|notifications sent on Wednesday
15917523|NCT03516019|Other|weekend notices|notifications sent on Saturday
15917524|NCT03516006|Drug|UCMSC|infusion of aUCMSC at day 0, 7, 14, and 21
15917525|NCT03516006|Drug|UDCA|oral administration of ursodeoxycholic acid (UDCA) 15mg/kg/d
15917526|NCT03515980|Drug|BMS-986231|Intravenous (IV) administration
15917527|NCT03515967|Device|I-PAS Goggles|Portable, head-mounted display goggle system with integrated eye capture technology
15917528|NCT03515954|Procedure|Treatment of diffuse ocular surface squamous neoplasia|Excision of the conjunctival tumour was done.Amniotic membrane was secured into conjunctival defects. Postoperative topical MMC 0.04% was given. Response to treatment was monitored clinically and by AS-OCT.
15917529|NCT03515941|Drug|Oxaliplatin|130 mg/m2 by IV (Arm 1)
15917530|NCT03515941|Drug|Capecitabine|625 mg/m2 (Arm 1), 1000 mg/m2 (Arm 1), 750 mg/m2 by PO (Arm 2)
15917531|NCT03515941|Drug|Leucovorin|400 mg/m2 by IV (Arm 1 & Arm 2)
15917532|NCT03515941|Drug|5-fluorouracil|400, 2400 mg/m2 by IV (Arm 1), 400,1200 mg/m2 by IV (Arm 2)
15917533|NCT03515941|Radiation|radiation|45 Gy in 1.8 Gy/fraction
15917534|NCT03515928|Other|Ultrasonic noise exposure|Group will be exposed to 40kHz ultrasonic noise at 110-120 dB SPL for 15 minutes.
15917535|NCT03515928|Diagnostic Test|Pure Tone Audiometry|Participants will undergo 2 (pre and post exposure) hearing tests
15917536|NCT03515902|Device|mouthguard|mouthguard
15917537|NCT03515902|Device|mouthguard with desensitizing toothpaste|mouthguard with desensitizing toothpaste containing 8% arginine with calcium carbonate
15917538|NCT03515889|Behavioral|Ideal Protein Weight Loss Method|"An initial visit will take place in which each participant assigned to the experimental group will complete a health profile questionnaire.The Ideal Protein method will be explained and the participant will be weighed, measured and given diet related informational materials. A staff member will assist the participant with the selection of foods and snacks to ensure adequate quantity for the week. Weekly follow-up visits of 15 minutes duration will be implemented with a telephone follow-up occurring during the first 4 days after the initial appointment.
~For 12 weeks Ideal Protein foods that are of the appropriate composition and quantity will be provided at weekly or twice monthly intervals as included in the diet. Dietary supplements will be provided (multivitamin, calcium/magnesium, potassium, omega-3, and Ideal Salt substitute)."
15917539|NCT03515889|Behavioral|Standard Weight Loss|"This arm utilizes evidence-based strategies that have been shown to be effective for long-term weight loss and weight loss maintenance (including behavioral techniques, diet modification, and social support) consistent with the 2013 AHA/ACC/TOS Guideline for the Management of Overweight and Obesity in Adults. Participants in this arm will have an initial one hour consultation with a trained interventionist, where the fat goal and calorie restriction goal are explained.
~For 12 weeks low-fat reduced calorie foods that are of appropriate composition and quantity will be provided at weekly or twice monthly intervals as included in the diet. Dietary supplements will be provided (multivitamin, calcium/magnesium, potassium, omega-3, and Ideal Salt substitute)."
15917540|NCT03515863|Genetic|DNA extraction and genetic characterization|Collection of blood samples for DNA extraction and genetic characterization using whole-genome sequencing, and for identification of cellular biomarkers using transcriptomics and mass cytometry.
15917541|NCT03515863|Device|Orbit MRI examination|Orbit MRI examination is performed to confirm the diagnosis of TAO
15917542|NCT03515863|Other|Collection of life style data|Collection of life style data using quality of life questionnaire
15917543|NCT03515837|Biological|pembrolizumab|IV infusion
15917544|NCT03515837|Drug|pemetrexed|IV infusion
15917545|NCT03515837|Drug|carboplatin|IV infusion
15917546|NCT03515837|Drug|cisplatin|IV infusion
15917547|NCT03515837|Drug|saline solution|IV infusion
15917548|NCT03515824|Biological|MK-1697|Administered by IV infusion on Day 1 of each 21-day cycle
15917549|NCT03515811|Device|Signia™ Stapling System|Signia™ Stapling System using Signia™ Intelligent Loading Units with Tri- Staple™ 2.0 Intelligent Reloads.
15917550|NCT03515798|Drug|Pembrolizumab Injection|Patients will receive intravenously 1 dose of Pembrolizumab every 3 weeks
15917551|NCT03515798|Drug|neoadjuvant EC-paclitaxel chemotherapy|The cytotoxic regimen is a combination of dose-dense EC, followed by weekly paclitaxel
15917552|NCT03515772|Drug|Co-administration of darunavir with a cardiovascular drug|Co-administration of darunavir, an HIV agent considered prone to induce drug interactions, with a cardiovascular drug (amlodipine, atorvastatin or rosuvastatin). Note that a patient will be able to participate in the intervention group and the control group if a change in his/her anti-HIV treatment occurs (study partly parallel and partly in cross-over).
15917553|NCT03515746|Device|Exergaming in virtual environment|"The 10 cubes task will be performed in virtual environment - either in 2D on a laptop computer or in 3D using 3D goggles"
15917554|NCT03515733|Drug|PF-04995274|PF-04995274 tablets
15917555|NCT03515733|Drug|Placebo Oral Tablet|Placebo tablet, identical appearance to experimental tablet
15917556|NCT03515720|Procedure|Prolotherapy|It consists of injecting 5% dextrose in sterile aqueous solution without the use of lidocaine in a subcutaneous nerve to inhibit neurogenic inflammation and the release of substance P and CGRP, decreasing neurogenic inflammation.
15917557|NCT03515707|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo ASCT
15917558|NCT03515707|Drug|Busulfan|Given IV or oral
15917559|NCT03515707|Drug|Etoposide|Given IV
15917560|NCT03515707|Other|Laboratory Biomarker Analysis|Correlative studies
15917561|NCT03515694|Drug|Sugammadex Injection [Bridion]|Injection of 10mL of translucide solution
15917562|NCT03515681|Behavioral|Text messages|Subjects randomized to intervention will receive text messages to promote seeking care and improving compliance with blood pressure treatment.
15917563|NCT03515668|Drug|Ritalin 20 mg Tablet|Single dose for all participants
15917564|NCT03515668|Drug|Placebo Oral Tablet|Placebo with same appearance/taste
15917565|NCT03515642|Behavioral|HIIT group|Physical Training
15917566|NCT03515629|Drug|REGN2810/ipi|REGN2810 plus ipilimumab
15917567|NCT03515629|Drug|REGN2810/chemo/ipi|REGN2810 plus chemotherapy plus Ipilimumab
15917568|NCT03515629|Drug|Pembrolizumab|Reference drug administered IV infusion
15917569|NCT03515616|Diagnostic Test|TP us in labour|TP US will be made to pregnant lady in first stage of labour with OS and PC angel measurements
15917570|NCT03515603|Procedure|Endoscopic resection|Transsphenoidal endoscopic resection of pituitary adenoma
15917571|NCT03515603|Procedure|Microsurgical resection|Transsphenoidal microsurgical resection of pituitary adenoma
15917572|NCT03515590|Other|Emulsion with solid droplets|This will be a 500 mL beverage emulsion in which the droplets are crystalline. It will have identical composition to the other intervention, i.e. in one the lipid droplets are solid (i.e. crystallized) and the other in which they remain liquid will be introduced at least 7 days apart. The differences in physical state will be achieved simply by changing the temperatures the emulsions are held at. The emulsion will contain 10 % of the lipid palm stearin with 0.4% of the emulsifier sorbitan monostearate (Span60).
15917573|NCT03515590|Other|Emulsion with liquid droplets|This will be a 500 mL beverage emulsion in which the droplets are liquid. It will have identical composition to the other intervention, i.e. in one the lipid droplets are solid (i.e. crystallized) and the other in which they remain liquid will be introduced at least 7 days apart. The differences in physical state will be achieved simply by changing the temperatures the emulsions are held at. The emulsion will contain 10 % of the lipid palm stearin with 0.4% of the emulsifier sorbitan monostearate (Span60).
15917574|NCT03515577|Procedure|Computed Tomography|Undergo PET/CT
15917575|NCT03515577|Drug|Fluciclovine F18|Given fluciclovine F18
15917576|NCT03515577|Drug|Gallium Ga 68-labeled PSMA-11|Given IV
15917577|NCT03515577|Other|Laboratory Biomarker Analysis|Correlative studies
15917578|NCT03515577|Procedure|Positron Emission Tomography|Undergo PET/CT
15917579|NCT03515564|Behavioral|Dance/Movement Therapy, Art Therapy, Mindful Yoga|Utilizing deep breathing, exercise modalities, and social support in all settings
15917580|NCT03515551|Drug|IMCnyeso|Weekly IV infusions of IMCnyeso
15917581|NCT03515538|Drug|RRx-001|RRx-001 for injection
15917582|NCT03515538|Drug|Cisplatin for injection|Patients will receive 3 doses of cisplatin at 100 mg/m2 in accordance with applicable guidelines such as NCCN; however, these guidelines are not intended to supersede or replace institutional guidelines with respect to appropriate and necessary care for individual patients
15917583|NCT03515538|Radiation|Radiation Therapy|Intensity Modulated Radiation Therapy (IMRT) in accordance with the American College of Radiology (ACR) and American Society for Radiation Oncology (ASTRO) Practice Guideline for IMRT) is mandatory for this study
15917584|NCT03515525|Diagnostic Test|Closed-suction drain fluid volume|To evaluate the clinical value of postoperative drain fluid volume for detection of hematoma, an intra-individual comparison of drain secretion volumes between sides affected by hematoma and the uneventful contralateral breasts was performed.
15917585|NCT03515512|Drug|Enasidenib|Enasidenib may help block the over production of IDH2, which when mutated, can overproduce metabolites and compounds that contribute to the growth of tumors and cancerous cells
15917586|NCT03515499|Behavioral|Incentives|Subjects in the treatment arm will be paid up to $1 per day over 3 months for perfect medication adherence. Adherence rates will then be compared between the 2 groups.
15917587|NCT03515499|Behavioral|Medication device monitoring and reminders|Bluetooth enabled sensor device for medication reminders, as well as mobile app to track medication use.
15917588|NCT03515486|Other|Post stroke mood disorders evaluation|Each patient will be assessed by a clinical evaluation, will have a standardized psychological evaluation, will perform a brain MRI and will be given a smartphone and an actimeter for a one-week period for the purpose of ecological evaluations
15917589|NCT03515473|Device|cochlear implant|cochlear implant surgery
15917590|NCT03515460|Other|sugar oral load|The individuals will receive a sugar oral load (high sugar meal)
15917591|NCT03515460|Other|fat oral load|The individuals will a receive fat oral load (high fat meal)
15917592|NCT03515460|Other|sugar and fat oral load|The individuals will a receive sugar and fat oral load (high sugar and high fat meal)
15917593|NCT03515447|Other|Non interventional study|
15917594|NCT03515434|Procedure|ESP Block|ESP block will be performed at the finishing of surgery under spinal anesthesia. A convex ultrasound transducer will be placed in a longitudinal parasagittal orientation 2-3 cm lateral to T10 spinous process. The erector spinae muscles will be identified superficial to the tip of T10 transverse process. The patient's skin will be anesthetized with 2% lidocaine. A 22-gauge 10-cm needle will be inserted using an out-plane superior-to-inferior approach to place the tip into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process. A total of 30 mL of bupivacaine/lidocaine mixture will be injected.
15917595|NCT03515434|Procedure|TAP Block|TAP block will be performed at the finishing of surgery under spinal anesthesia. A linear ultrasound transducer will be placed to lateral aspect of abdomen. A 22-gauge 10-cm needle will be inserted using an out-plane superior-to-inferior approach to place the tip into the fascial plane between transversus abdominis and internal oblique muscles..A total of 30 mL of bupivacaine/lidocaine mixture will be injected.
15917596|NCT03515434|Other|Standard Pain Followup and Monitorization|Numeric Rating Scale (NRS) pain score will be recorded and followed by 0., 1.-3.-6.-12.-18.-24.hours. it is planned that the patient will continue to follow the hourly NRS score in ward. Intramuscular diclofenac will be administered in this period if NRS 4 and if it is over, intravenous 0.5 mg / kg meperidine will be administered if NRS score is 4 or more after 2 hours. Salvage analgesic needs and times will be noted in detail, and the use of rescue analgesics, as well as NRS scores at designated hours, will be kept in a statistical evaluation.
15917597|NCT03515421|Device|Frazier 3 Verio|In vitro diagnostic device (IVDD)
15917598|NCT03515421|Device|Frazier 3 UltraPlus|In vitro diagnostic device (IVDD)
15917599|NCT03515408|Device|rTMS|The 10-Hz stimulation is delivered at 100% of the subject's resting motor threshold via 60 trains of 3-s 10-Hz rTMS (30 pulses with 27-s duration per train).
15917600|NCT03515395|Behavioral|Instruction to a computer game and motivation to use it|Patients who are willing to use the computer game and who have given written informed consent shall have three instruction sessions by a physiotherapist instructor. They will then asked to use the platform at least 3 times per week at their own discretion. The platform will be installed in the patient room, alternatively in a defined training room. The patient will be free to choose the time and duration of the gaming. This allows the patients to select times that do not interfere with their usual therapy schedule or visits (e.g. evening or weekends). Prior to discharge compliance with the platform will be monitored by analyzing the gaming data of each patient.
15917601|NCT03515382|Drug|GLPG1690|A single oral dose of GLPG1690.
15917602|NCT03515382|Drug|Itraconazole|A single oral dose of itraconazole.
15917603|NCT03515382|Drug|Voriconazole|A single oral dose of voriconazole.
15917604|NCT03515369|Drug|Babaodan oral capsule|On the basis of conventional liver protecting treatment, take Babaodan oral capsule within 4 weeks after curative resection. Take two capsules three times daily, two months as a course of treatment and the maximum of eighteen courses, until the recurrence of tumor or death of patients (non tumor related death), or the termination of research.
15917605|NCT03515369|Drug|Placebo oral capsule|On the basis of conventional liver protecting treatment, take Placebo oral capsule began within 4 weeks after curative resection. Take two capsules three times daily, two months as a course of treatment and the maximum of eighteen courses, until the recurrence of tumor or death of patients (non tumor related death), or the termination of research.
15917606|NCT03515356|Behavioral|MI-Walk Intervention|Eight-week motivational enhancement therapy and home-based aerobic walking intervention
15917607|NCT03515356|Behavioral|Physical Activity Education Pamphlet|Physical activity education pamphlet only
15917608|NCT03515343|Diagnostic Test|Screening colonoscopy according to resect-and-discard strategy|This strategy uses image enhancing techniques and optical diagnosis instead of histopathology assessment with 2 Pentax optical imaging systems (either Optivista or iScan).
15917609|NCT03515330|Other|mHealth Intervention|The mHealth application will allow liver transplant recipients to see their medication regimen, record a video of themselves taking every dose, report side effects or symptoms, visualize their treatment progress, and access educational content. This information is encrypted and transmitted to a HIPAA-secure web portal for providers to review.
15917610|NCT03515317|Behavioral|LoRETA Z-score NF|LoRETA Z-score NF will be conducted using a 19-lead cap (Electrocap, Inc), which will be placed on the head according to the standard approach of the international 10-20 system with linked ear and ground reference. After the caps will be less than 5 kΩ. During each session, the participants will sit in front of a computer screen on which predesigned games or animations related to the LoRETA Z-score training are played and instructions regarding the inhibitory and reward aspects of the training are taught.
15917611|NCT03515317|Behavioral|theta/beta NF|The goal of theta/beta NF is to increase the beta power(13-20 Hz) and simultaneously inhibit the theta power (4-8 Hz) relative to a baseline assessed at the beginning of a training session. The electrodes will be placed on Fz and Cz with a linked ear model(A1). The study will use both visual and auditory feedback. Each participant will sit in front of a computer screen on which predesigned games or animations related to the training criteria are played and instructions regarding the inhibitory and reward aspects of the training are taught. The threshold will be set according to 5-min baseline EEG measurements before each session. The thresholds are the mean amplitude of the beta and the theta in 5-min baseline EEG.
15917612|NCT03515304|Drug|Evolocumab|420 mg evolocumab administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
15917613|NCT03515304|Drug|Placebo|Placebo administered subcutaneously using an autoinjector/pen in NSTEMI patients within 24 hours, or one day, of admission.
15917614|NCT03515291|Biological|iMP cells|Immunomodulatory progenitor cells
15917615|NCT03515291|Other|Control injection|Cell suspension solution
15917616|NCT03515278|Procedure|SCNB group|IACI can provide rapid effect in pain reliving, reducing inflammation and improving ROM that could increase the compliance of exercise therapy.
15917617|NCT03515278|Procedure|IACI group|SCNB is a new choice for treatment of frozen shoulder.As radiology techniques advance, ultrasound-guided SCNB becomes more popular. It provides a cost and time-effective way to infiltrate the nerve accurately without injury to the nerves or vessels.
15917618|NCT03515265|Other|Fiber reinforced resin composite restoration|a type of resin composite with improved strength due to the fiber's action
15917619|NCT03515265|Other|Microhybrid resin composite restoration|a type of conventional resin composite
15917620|NCT03515252|Biological|Immune Killer Cells (IKC)|
15917621|NCT03515239|Procedure|lumbopelvic fixation for spinopelvic dissociation|unilateral and bilateral lumbopelvic fixation for spinopelvic dissociation
15917622|NCT03515226|Behavioral|ITS based training|Training using computerized adaptive training in addition to role play
15917623|NCT03515226|Behavioral|Traditional Training|Training using didactics and role plays
15917624|NCT03515213|Drug|Fenofibrate|145mg of fenofibrate
15917625|NCT03515213|Drug|Placebo|Placebo
15917626|NCT03515200|Drug|Palbociclib Oral Capsule|Given orally or nasogastrically (NG).
15917627|NCT03515200|Drug|Intrathecal Triple Therapy|Given intrathecally (IT).
15917628|NCT03515200|Drug|Dexamethasone|Given orally, nasogastrically (NG) or intravenously (IV).
15917629|NCT03515200|Drug|Bortezomib|Given intravenously (IV) or subcutaneously (SC).
15917630|NCT03515200|Drug|Dasatinib|Given orally or nasogastrically (NG).
15917631|NCT03515200|Drug|Doxorubicin|Given intravenously (IV).
15917632|NCT03515200|Drug|Ruxolitinib|Given orally or nasogastrically (NG).
15917633|NCT03515187|Drug|0.3% sodium hyaluronate ophthalmic solution|one to two drops in eye, four times per day
15917634|NCT03515187|Drug|0.1% sodium bromide solution|one to two drops in eye, twice per day
15917635|NCT03515187|Other|Meibomian gland massage|Physiotherapy
15917636|NCT03515187|Other|Placebo|Vehicle
15917637|NCT03515174|Other|Supportive Care Program|This program takes place within one month post-diagnosis of cancer. It will include three info-educational session. After that, recommendations for further consultation with specific healthcare professionals will be made based on the concerns and needs of patients at baseline. Patient will also be given usual care.
15917638|NCT03515174|Other|Usual Care|Patients will be provided with an information booklet by the study team on self-management of cancer- and treatment-related symptoms, which is routinely provided by the National Cancer Centre of Singapore (NCCS) after cancer diagnosis. Usual general advice is provided by the medical oncologists during the routine consultations.
15917639|NCT03515161|Device|closed-loop|Vasopressor admnistration in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of vasopressor the patient receives using feedback from standard operating room monitors.
15917640|NCT03515148|Procedure|Cryotherapy and eccentric exercise|12 weeks, 5 days/week, once a day, 2 exercise, 3 sets/execise, 15 repetition/set of eccentric exercise of foot plantar flexors First exercise with knee in extension, second exercise with knee in flexion. Previously subjects should cold their leg in ice water during sexteen minutes at a temperature of 8ºC (+/-2ºC)
15917641|NCT03515148|Procedure|Vibration and eccentric exercise|12 weeks, 5 days/week, once a day, 2 exercise, 3 sets/execise, 15 repetition/set of eccentric exercise of foot plantar flexors First exercise with knee in extension, second exercise with knee in flexion.During the exercise subjects will be subjected to vibration. Vibrations parameters: Frequency: 35Hz, Amplitude: 4 milimeters, Force: 3,9G
15917642|NCT03515135|Behavioral|Metacognitive Executive Function Training|Training the executive funtions of preshcool ADHD children through tasks and games repeatly but with fun. Giving the parents strategies to help the prechool ADHD childred coping the symptoms and develop EF in the reallife.
15917643|NCT03515109|Procedure|Altis tape|placement of Altis tape through transobturator foramen bilaterally under epidural anesthesia
15917644|NCT03515109|Procedure|TVTO|placement of TVTO tape through transobturator foarmen bilaterally under epidural anesthesia
15917645|NCT03515096|Drug|Eltrombopag|Eltrombopag 50 mg; po; from day 1 to platelet is completely effective recovered after HSCT.
15917646|NCT03515096|Drug|rhTPO|rhTPO 15000 u; subcutaneously injection; from day 1 to platelet is completely effective recovered after HSCT.
15917648|NCT03515057|Diagnostic Test|Single lead handheld electrocardiogram|Screening for atrial fibrillation during outpatient primary care office visits among patients 65 years and older
15917649|NCT03515044|Drug|40 mg Rifaximin SSD once daily|SSD once daily (QD) and lactulose
15917650|NCT03515044|Drug|40 mg Rifaximin SSD twice daily|SSD twice daily (BID) and lactulose
15917651|NCT03515044|Drug|80 mg Rifaximin SSD once daily|SSD once daily (QD) and lactulose
15917652|NCT03515044|Drug|80 mg Rifaximin SSD twice daily|SSD twice daily (BID) and lactulose
15917653|NCT03515044|Drug|Placebo|Administered twice daily (BID) and lactulose
15917654|NCT03515044|Drug|lactulose|to be taken in the recommended adult size dosage.
15917655|NCT03515031|Device|High Flow Nasal Cannula Oxygenation|Delivery of humidified and heated (37ºC) high flow oxygen
15917656|NCT03515031|Device|Venturi Mask Oxygenation|delivery of high flow oxygen
15917657|NCT03515018|Drug|hydroxyurea|pulse therapy
15917658|NCT03515018|Drug|Imatinib|400mg qd PO per day
15917659|NCT03515005|Behavioral|Lay Health Advisor|Patients will meet regularly Lay Health Advisors who will address the social context of their hypertension.
15917660|NCT03514979|Biological|Pneumococcal Polysaccharide Conjugate vaccination and Pneumococcal Polysaccharide Vaccination|Pneumococcal vaccines
15917697|NCT03514745|Device|Lighted stylet|Endobronchial intubation is performed using a lighted stylet.
15917661|NCT03514966|Behavioral|Position change group|Right after ingesting 5 g dimethicone mixed with 100 ml water, subjects in the position change group will be instructed to repeatedly change the body position according to a pre-specified protocol for a period of 15 min: in the order of supine to the left lateral position to prone, left lateral, supine, right lateral, and repeat last four positions twice, each for 1 min; finally supine for 1 min. Thirty and 40 min after dimethicone administration, subjects in both groups will additionally take 200 ml and 800 ml water, respectively before undergoing MCE examination.
15917662|NCT03514953|Behavioral|Reduced Physical Activity|"Preliminary Phase (Baseline to Day 7): Subjects will begin wearing an accelerometer for 7 days to track physical activity and sleep patterns.
~Experimental Phase 1 (Day 7 to Day 21): Participants will be required to reduce their step count by 5,000 steps per day and engage in no moderate-vigorous physical activity during this timeframe. Every 7 days subjects undergo the blood draw, vascular health measures and questionnaire assessments.
~Experimental Phase 2 (Day 21 to 28): During the week of assessment, subjects will be asked to return to their normal physical activity patterns."
15917663|NCT03514940|Diagnostic Test|ultrasound|second trimester us scan will be made to pregnant women
15917664|NCT03514927|Procedure|Contrast-Enhanced Ultrasound|Undergo CEUS
15917665|NCT03514927|Device|High-Intensity Focused Ultrasound|Under go HIFU
15917666|NCT03514927|Other|Laboratory Biomarker Analysis|Correlative studies
15917667|NCT03514927|Procedure|Multiparametric Magnetic Resonance Imaging|Undergo mpMRI
15917668|NCT03514927|Procedure|Radical Prostatectomy|Undergo prostatectomy
15917669|NCT03514914|Behavioral|The CHARM2 Intervention|CHARM2 intervention will involve gender, culture & contextually-tailored family planning and gender equity counseling.
15917670|NCT03514901|Other|Experimental combination beyond Focal Progression|"Vemurafenib is taken on a 28-day cycle. Each dose consists of four 240 mg (960 mg) tablets twice daily for 28 consecutive days. The first dose should be taken in the morning and the second dose in the evening approximately 12 hours later. Each dose can be taken with or without a meal. Vemurafenib tablets should be swallowed whole with a glass of water and should not be chewed or crushed.
~Cobimetinib is taken on a 28-day cycle. Each dose consists of three 20 mg tablets (60 mg) and should be taken orally, once daily for 21 consecutive days, followed by a 7-day break. Each subsequent treatment cycle should start after the 7-day treatment break has elapsed. The dose should be taken in the morning.
~Local treatment (i.e. surgery, radiotherapy)."
15917671|NCT03514901|Drug|Pembrolizumab or Nivolumab|Pembrolizumab 2 mg/kg is administered as an intravenous infusion over 30 minutes every 3 weeks OR Nivolumab 3 mg/kg is administered intravenously over 60 minutes every 2 weeks.
15917672|NCT03514888|Procedure|HIPEC|40mg of Mitomycin-C dissolved in 100ml normal saline will be added into the perfusate and instilled into the patient for a total of 60 minutes. After 60 minutes, the abdomen will be irrigated with 3 liters of normal saline.
15917673|NCT03514875|Dietary Supplement|MitoQ|MitoQ is a mitochondria-targeting antioxidant, which should improve NO bioavailability, and therefore vasodilation
15917674|NCT03514875|Dietary Supplement|Placebo|A placebo will be used in a double blinded, randomized, cross-over design
15917675|NCT03514862|Behavioral|Mindfulness Booster Training|Four additional mindfulness booster sessions after the 4-week MBI program.
15917676|NCT03514862|Behavioral|Mindfulness-Based Intervention (MBI)|MBI program is delivered once a week for 4 weeks, 90 minutes each preceded by a 90-minute orientation session. The training sessions will include discussion, and introduction and practice of mindfulness practices.
15917677|NCT03514862|Behavioral|Self-Practice|4 weeks of self-practice after the MBI training.
15917678|NCT03514849|Procedure|prophylactic cranial irradiation (PCI)|Patients in the control group are enrolled in the follow-up, and the patients in research group will receive prophylactic cranial irradiation （PCI） by 25 gy/10 fx.
15917679|NCT03514849|Procedure|lobectomy + mediastinal lymph node dissection or systematic lymph node sampling|lobectomy + mediastinal lymph node dissection or systematic lymph node sampling
15917680|NCT03514849|Drug|postoperative adjuvant chemotherapy|If the postoperatively pathological examination of the patient is confirmed to be in pT1-2N0 stage, a single postoperative adjuvant chemotherapy (combining etoposide with cisplatin) is recommended. If patients are difficult to tolerate the side effects of cisplatin, we can replace cisplatin by carboplatin in the adjuvant chemotherapy scheme.
15917681|NCT03514836|Biological|DCVac/PCa|"Oncolytic adenovirus containing immunostimulatory cytokine granulocyte-monocyte colony-stimulating factor (GM-CSF). This is an experimental therapy.
~DCVac/Pca consists of activated autologous dendritic cells. This is an experimental therapy."
15917682|NCT03514836|Drug|Cyclophosphamide|immunomodulatory medication given around the ONCOS-102 dosing
15917683|NCT03514823|Other|Inspiratory Muscle Training (IMT)|Inspiratory muscle training (IMT) are breathing exercises used to increase strength and endurance of the respiratory muscles.
15917684|NCT03514823|Other|No Inspiratory Muscle Training (IMT)|No inspiratory muscle training.
15917685|NCT03514810|Combination Product|Combined Sertraline & Ketoprofen|The first group of patients has administered sertralin (50mg)+placebo. The second group has administered sertralin (50mg)+ketoprofen (100mg) (Sertraline & Ketoprofen) daily.
15917686|NCT03514810|Other|Interleukins in MDD after treatment|Some interleukine levels were estimated in the first group of patients (administered sertralin,50mg+ketoprofen,100mg) and compared with their level in the second group (administered sertralin (50mg)+placebo).
15917687|NCT03514797|Drug|Bleaching Agents|In-office tooth bleaching with 35% hydrogen peroxide in a single application of 45 minutes.
15917688|NCT03514797|Drug|Bleaching Agents|At-home tooth bleaching with 10% carbamide peroxide for 1 hour per day.
15917689|NCT03514784|Drug|BB-12 with LGG (Higher Dose)|BB-12 with LGG - Higher Dose (10 billion CFUs)
15917690|NCT03514784|Drug|Placebo|Maltodextrin
15917691|NCT03514784|Drug|BB-12 with LGG (Lower Dose)|BB-12 with LGG - Lower Dose (1 billion CFUs)
15917692|NCT03514771|Device|Fraxel DUAL 1550/1927|
15917693|NCT03514771|Drug|oral isotretinoin|oral isotretinoin
15917694|NCT03514771|Drug|oral valacyclovir|Oral valacyclovir
15917695|NCT03514758|Procedure|several virtual 3-D complex audio environments|The focus is a comparison of four virtual 3-D complex audio environments with regard to the sensitivity of hearing aid algorithms.
15917696|NCT03514745|Device|GlideScope|Endobronchial intubation is performed using the GlideScope.
15917698|NCT03514732|Drug|MELATONIN (MELATL07959)|Pharmaceutical form:Capsule Route of administration: Oral
15917699|NCT03514719|Diagnostic Test|89Zr-avelumab PET|89Zr-avelumab injection followed by 89Zr-Avelumab PET scan
15917700|NCT03514719|Drug|Avelumab|"Early stage disease (stage Ia (≥T1b tumor)-IIIa: neo-adjuvant avelumab treatment (10mg/kg iv q2w) for a maximum duration of 2 cycles after PET-imaging, followed by surgical resection of the tumor with curative intent
~Stage IIIb-IV disease: systemic treatment with avelumab 10mg/kg iv q2w after PET-imaging"
15917701|NCT03514706|Diagnostic Test|volume controlled ventilation|"Lung ultrasound (LUS) will be performed with a 2-4 MHz phased array probe. Patients will be scanned in supine position by a recording 5 seconds videos. LUS will be assessed for the presence of B lines.
~The sum of lung comets produces a score reflecting the extent of lung water accumulation. LUS will be obtained by scanning 12-rib interspaces. The sum of B-lines on each scanning site yields a score from 0 to 36"
15917702|NCT03514706|Diagnostic Test|pressure controlled ventilation|"Lung ultrasound (LUS) will be performed with a 2-4 MHz phased array probe. Patients will be scanned in supine position by a recording 5 seconds videos. LUS will be assessed for the presence of B lines.
~The sum of lung comets produces a score reflecting the extent of lung water accumulation. LUS will be obtained by scanning 12-rib interspaces. The sum of B-lines on each scanning site yields a score from 0 to 36"
15917703|NCT03514693|Procedure|PVI|Ipsilateral circumferential PVI is the recommended PVI strategy. The success of PVI is defined as the achievement of the dissociation of PV potentials in all PVs. Disappearance of PV potentials is reconfirmed at the end of the procedure, a minimum of 20 minutes after the initial success of PVI.
15917704|NCT03514693|Procedure|PVI plus additional ablation|In addition to PVI, CFAE ablation, linear ablation, or both; the choice of which is decided by the physician
15917705|NCT03514680|Behavioral|CIPN Assessment and Management Algorithm|The revised algorithm incorporates evidence-based CIPN assessment and management strategies and standardized CIPN/pain patient-reported outcomes measures. In terms of processes, trained study staff will administer the screening questionnaires (e.g., PRO-CTCAE, 0 - 10 numerical rating scale of worst CIPN pain intensity) to consented patients before their clinician visit (e.g., in the waiting room). Following patient completion of the screening questionnaires, study staff will provide the clinicians with a color-coded summary of the patients' responses to the screening questionnaires and the CIPN assessment and management algorithm. Clinicians may then use the algorithm at their discretion to guide the assessment and management of their patients' CIPN symptoms
15917706|NCT03514667|Dietary Supplement|nanomicielle curcumin|Participants will be selected from those referring to endocrinology clinics of Shohadaye YaftAbad and Pars Hospital (Tehran, Iran) who meet the inclusion criteria. Each subject will give informed written consent to participate in the study. 10 cc fasting blood samples will be collected from each subject at baseline and at the end of trial. Anthropometric parameters will be measured.In order to control the confounding factors in patients, they will be randomly assigned to receive either nanomicielle curcumin or placebo. nanomicielle curcumin and placebo supplements will be provided from the Elixir Nano Sina Company the patients will advise not to change their lifestyle during the study.
15917707|NCT03514667|Dietary Supplement|placebo|Participants will be selected from those referring to endocrinology clinics of Shohadaye YaftAbad and Pars Hospital (Tehran, Iran) who meet the inclusion criteria. Each subject will give informed written consent to participate in the study. 10 cc fasting blood samples will be collected from each subject at baseline and at the end of trial. Anthropometric parameters will be measured.In order to control the confounding factors in patients, they will be randomly assigned to receive either nanomicielle curcumin or placebo. nanomicielle curcumin and placebo supplements will be provided from the Elixir Nano Sina Company the patients will advise not to change their lifestyle during the study.
15917708|NCT03514654|Procedure|Mastectomy|Removal of the whole breast.
15917709|NCT03514654|Procedure|Therapeutic Mammoplasty|Excision via lumpectomy of multifocal or multicentric cancers with breast volume displacement techniques to maximise cosmetic outcomes.
15917710|NCT03514641|Drug|Bexagliflozin|Bexagliflozin tablet, 20 mg
15917711|NCT03514641|Drug|Placebo|Placebo (inactive) tablet to match the active drug
15917712|NCT03514628|Other|Standard Care|The Valsalva strain will be produced using Standard Care techniques
15917713|NCT03514628|Device|Valsalva Assist Device (VAD)|Use of Valsalva Assist Device (VAD) to generate VM
15917714|NCT03514615|Procedure|Incision|A skin incision will be made on the medial aspect of the upper arm.
15917715|NCT03514615|Drug|Active gel|The incision site on one arm will be dosed with the active gel.
15917716|NCT03514615|Drug|Placebo gel|The incision site on the other arm will be dosed with placebo gel.
15917717|NCT03514602|Behavioral|Multicomponent behavioral intervention|Pregnant patients in the intervention group will receive multicomponent interventions consisting of education, feedback, contingent financial incentives, and peer support. At initial intervention visit, they will choose a quit date within the next 14 days and sign a no-smoking pledge and a no-smoking contract. The contract lists the intervention components, the patient's and the counselor's responsibilities, importance of keeping scheduled visits, and rules on contingent incentives. After the quit date, pregnant women will meet with counselors daily for 5 consecutive days (Monday to Friday) for abstinence monitoring in weeks 1-2. The frequency of abstinence monitoring will decrease to twice a week (Monday and Thursday) in weeks 3-8, weekly in weeks 9-12, and biweekly in weeks 13 until delivery.
15917718|NCT03514602|Behavioral|Education only control|"The control group will receive one 60-minute counseling mainly based on a pregnancy-tailored self-help booklet entitled Need Help Putting Out That Cigarette? distributed by the American College of Obstetricians and Gynecologists."
15917719|NCT03514589|Drug|nasal Tetracosactide|Bioavailability of nasal synacthen compared to IV comparator
15917720|NCT03514589|Drug|IV tetracosactide|Bioavailability of nasal synacthen compared to IV comparator
15917721|NCT03514576|Drug|Pasireotide 0.3 MG/ML|See arm description
15917722|NCT03514576|Diagnostic Test|Meal tolerance test (MTT)|Subjects will consume the liquid meal at baseline and blood will be drawn for continuous blood sampling.
15917723|NCT03514563|Diagnostic Test|MRI imaging|MRI recordings of the craniofacial region
15917724|NCT03514563|Diagnostic Test|Optical scan|Optical intraoral scans
15917725|NCT03514563|Diagnostic Test|3D photography|Facial stereophotogrammetry
15917726|NCT03514550|Drug|Propofol|Propofol will be used for anesthesia during surgery
15917727|NCT03514550|Drug|Sevoflurane|Sevoflurane will be used for anesthesia during surgery
15917728|NCT03514550|Procedure|Epidural block|Epidural catheterization Th9-Th10, ropivacaine for perioperative analgesia
15917729|NCT03514537|Procedure|Microcannula harvest adipose stromal tissues|Use of disposable, closed syringe microcannula harvest autologous adipose stroma and stem/stromal cells
15917730|NCT03514537|Device|Centricyte 1000|Centricyte 1000, closed system digestion of stromal vascular fraction to isolate and concentrate stem/stromal cells associated with microvasculature
15917731|NCT03514537|Procedure|Sterile Normal Saline IV Deployment of cSVF|Sterile Normal Saline Suspension cSVF in 500 cc for Intravenous Delivery including 150 micron in-line filtration
15917732|NCT03514537|Drug|Liberase|Liberase TM for use to enzymatically isolate cellular stromal vascular fraction
15917733|NCT03514537|Drug|Saline Solution|Sterile, Normal Saline 500 for Intravenous use
15917734|NCT03514524|Other|PET-MR imaging|Both 18F-MK-6240 and 11C-UCB-J PET-MR will be performed at base-line (all arms) 6 months after TBI/stroke (TBI and stroke arm) and after 2 years (TBI, stroke, CTE and MCI/MBI arls)
15917735|NCT03514511|Drug|LEO 138559|LEO 138559 is a compound in development at LEO Pharma A/S
15917736|NCT03514511|Drug|LEO 138559 placebo|LEO 138559 placebo
15917737|NCT03514498|Procedure|Dental surgery|All types of dental surgery
15917738|NCT03514485|Behavioral|Yes We Can Children's Asthma Program|The Yes We Can Children's Asthma Program intervention is a medical-social model based on a chronic care approach, including risk stratification, clinical care management, social care coordination by a community health worker, and primary care physician asthma champions. This intervention includes asthma education, trigger reduction visits and care coordination. There will be five clinic visits and four home visits over 12 months implemented by the primary care CHW who is integrated into the primary care practice.
15917739|NCT03514485|Behavioral|School-Based Asthma Therapy|School-Based Asthma Therapy includes enhanced care coordination for prescribed daily controller medication. The school nurse will coordinate with teachers and the school CHW to schedule daily controller asthma medication administration. The school CHW will assist in obtaining a current asthma care plan and medication administration form from the primary care provider.
15917740|NCT03514485|Behavioral|Open Airways for School Plus|"Open Airways for Schools Plus was designed to improve the asthma self-management skills in children and enhance control of asthma in the school. The school intervention includes:
~Open Airways for Schools curriculum for all students with asthma. Classes will be conducted by the school CHW once each semester.
~Environmental classroom assessments conducted by school CHWs for students enrolled in the study. These teachers will receive classroom supplies to create a more asthma-friendly classroom environment.
~Asthma education for school staff/personnel at the start of each school year.
~School facility walk-through assessments to detect potential environmental asthma triggers will be conducted by the School District of Philadelphia."
15917741|NCT03514472|Dietary Supplement|Dried Moringa oleifera leaves|
15917742|NCT03514459|Other|Systems Analysis and Improvement Approach|SAIA has five steps. The first step uses an Excel-based tool to quantify drop- offs, or people who did not progress, in each step of a process (Figure 1). This tool also allows the user to see the downstream effect when improving one step in the cascade, and holding the other steps constant. Step 2 involves process flow mapping with clinic staff to identify modifiable bottlenecks in the process. Step 3 develops and implements a workflow modification to address a bottleneck identified in step 2 (continuous quality improvement [CQI] step). Step 4 assesses impact of the modification and recalculates the cascade analysis in step 1 (CQI step). Step 5 repeats the cycle for CQI. SAIA draws from systems engineering in the Toyota Production Systems and from research in LMICs. Studies in quality improvement in LMICs highlight that CQI processes led to more sustainable, effective, and appropriate interventions (42-44).
15917743|NCT03514446|Drug|Antibiotic therapy duration for 7 days|Antibiotic therapy for seven days
15917744|NCT03514433|Other|TRIP Patient Navigation Intervention|The TRIP intervention will replace the current standard of care at the 6 participating hospitals once it is rolled out on-site. Any TRIP eligible patients receiving patient navigation services over the course of the study will receive the enhanced services.
15917745|NCT03514420|Drug|AKCEA-ANGPTL3-LRx|AKCEA-ANGPTL3-LRx solution for SC injection.
15917746|NCT03514407|Drug|INCB059872|Part 1: Initial cohort of INCB059872 administered every other day (QOD) at the protocol-defined starting dose, with subsequent cohort dose escalation based on protocol-defined criteria. Part 2: Expansion with the recommended dose from Part 1.
15917747|NCT03514394|Behavioral|Problem Solving Therapy|six weekly sessions to train patients in seven step problem solving method.
15917748|NCT03514394|Behavioral|Modified PST|This intervention will contain elements of problem solving therapy, cognitive process therapy, and other interventions clinicians determine are important in their patient population
15917749|NCT03514381|Drug|Patients starting a treatment with Doxorubicin and Ifosfamide|"9 blood samples will be collected at each Cycle:
~Cycle 1 (Day 1-Day 2-Day 3)
~Cycle 2 (Day 1-Day 2-Day 3)"
15917750|NCT03514368|Other|Patients treated with immune checkpoint blockade|"Tumor biopsy specimens and blood samples will be collected at different time points:
~Baseline
~before the 3rd ICB administration (blood samples only)
~before the 5th ICB administration (blood samples only)
~at the time of treatment permanent discontinuation (blood samples only)
~at the time of progression (tumor biopsy specimens only)
~after the last dose of ICB treatment (blood samples only taken twice per year until study termination)"
15917751|NCT03514355|Behavioral|Mindfulness-Based Stress Reduction|8 weekly 2.5 h sessions plus one day of practice
15917752|NCT03514342|Procedure|Interscalene brachial plexus block|Under ultrasound guidance, the 5th to 7th cervical nerve roots are identified between anterior and middle scalene muscles and subsequently blocked.
15917753|NCT03514342|Drug|0.75% ropivacaine|Placement of 25 to 30 ml of 0.75% ropivacaine around the 5th to 7th cervical nerve roots
15917804|NCT03513952|Biological|Glycosylated Recombinant Human Interleukin-7|Given IM
15917805|NCT03513952|Other|Laboratory Biomarker Analysis|Correlative studies
15917837|NCT03513627|Procedure|Post-occlusive reactive hyperemia test (PORH test)|Compression is applied on the buccal side of the attached gingiva, perpendicular to the long axis of the natural or implant born crown 2 mm far from the gingival margin.
15918207|NCT03511118|Other|Topiramate|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15917755|NCT03514316|Procedure|Scalpel Gingivectomy|The patients were anesthetized in the area around the teeth which were to undergo the procedure with local anesthesia (Drug: 2% lidocaine and 1:80,000 adrenaline). Initially, the Periodontal Probing Depth was measured and when sufficient anesthesia was achieved, biologic width calculation was done by the trans-gingival probing method. Once the amount of gingival tissue to be excised was demarcated, an external bevel incision was performed by using a scalpel blade (Device: scalpel blade No.15) and the gingival tissue was excised. Left out tissue tags and any beads of granulations tissue were removed to attain a smooth surface.
15917756|NCT03514316|Procedure|Laser Gingivectomy|In the Laser Gingivectomy group, the procedure was performed by using a 810 nm diode laser (Device: 810 nm FOX III diode laser) . Though a local anesthetic gel is sufficient considering that the procedure is minimally invasive, the area was adequately anesthetized with 2% lidocaine and 1:80,000 adrenaline. The laser unit, comprising of a 300 μm disposable tip, was used in a contact mode with a setting of 1 to 1.5 watts in continuous mode along the demarcated area with a paint brush like strokes progressing slowly to remove the gingival tissue and expose adequate amount of tooth structure. High-volume suction was used to evacuate the laser plume and charred odor
15917757|NCT03514316|Procedure|Nonsurgical periodontal treatment|In all subjects of the Control Group a full-mouth periodontal debridement was performed at baseline, 1 and 3 months with an ultrasonic scaler. Chlorhexidine prophylaxis (0.05% chlorhexidine gluconate) was also administered twice a day for 2 weeks after the periodontal treatment. Oral-hygiene instructions were reinforced again.
15917758|NCT03514303|Diagnostic Test|Spiriplex Allergenex Microassay|A microassay test using a minimal blood draw for purposes of testing the allergenicity of a subject to specific allergenic proteins.
15917759|NCT03514290|Radiation|Low-lever laser|Received Low-lever laser therapy using the infrared spectrum, with a wavelength of 808 nm in its active medium AsGaAl (arsenic-gallium-aluminum), at two points: on the central of cervical and medial regions of incisors, canines and premolars in the corresponding hemi-arch. At each point, 60 J/cm2 was applied during 16 seconds with an irradiance of 3.75 W/cm² using the therapeutic visible infrared device.
15917760|NCT03514290|Other|Tooth bleaching|Three 15-minute applications of 35% hydrogen peroxide gel (Whiteness HP, FGM®, Joinville, SC, Brazil) were carried out, totaling 45 minutes in each of the four bleaching sessions, with an one-week interval between applications.
15917761|NCT03514290|Other|Placebo|The laser tip was positioned similarly to experimental group but without light irradiation
15917762|NCT03514277|Drug|Exparel|1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL
15917763|NCT03514277|Drug|Bupivacaine|30 mL bupivacaine 0.5% w/v solution
15917764|NCT03514264|Procedure|Gutta Percha and AHPLUS cement (group A)|"First intervention: endodontic instrumentation and introduction of intact medication that will remain inside the tooth for 4 weeks.
~Second intervention: removal of intracanal medication and canal filling with cement AHPLUS and guttapercha"
15917765|NCT03514264|Procedure|PBS CIMMO cement (group B)|Single intervention: endodontic instrumentation and obturation with cement PBS CIMMO
15917766|NCT03514251|Procedure|The suture marks the location of the parathyroid gland|When the lower parathyroid gland is first seen, the parathyroid gland is sutured with a suture during the operation, and then during this subsequent cleaning, rapid parathyroid localization and parathyroid glands are performed through this marker. Vascular protection.
15917767|NCT03514238|Behavioral|High Intensity Interval Aerobic Exercise (HIIT)|"Cycling at 50-55% heart rate reserve for 5 minutes followed by 2 minutes of cycling at 85-90% heart rate reserve consecutively for a total of 35 minutes.
~Blood draws will occur at 6 different time points during exercise (0min, 7min, 14min, 21min, 28min, 35min)."
15917768|NCT03514238|Behavioral|Continuous Moderate Aerobic Exercise (MOD)|35 minutes of cycling at 50-55% heart rate reserve. Blood draws will occur at 6 different time points during exercise (0min, 7min, 14min, 21min, 28min, 35min).
15917769|NCT03514238|Behavioral|Control Sitting Condition (C)|Blood draws matched for exercise time will be taken while participant remains seated for 35 minutes (0min, 7min, 14min, 21min, 28min, 35min).
15917770|NCT03514225|Other|Metacognitive Therapy for Social Anxiety|The transdiagnostic Metacognitive model posits that psychological disorder stems from the activation of a perseverative thinking style called the CAS (Cognitive Attentional Syndrome). This has 3 key elements: worry/rumination, threat-focussed attention and unhelpful coping behaviours. Each of these elements results in extended cognitive responses to negative thoughts, prolonging negative emotions and maintaining an individual's sense of threat. The CAS arises from an individual's positive and negative metacognitive beliefs (beliefs about cognition). Metacognitive Therapy (MCT) aims to bring the CAS under control by modifying metacognitive beliefs and enabling individuals to develop new reactions to negative thoughts.
15917771|NCT03514212|Behavioral|ProActiveS|A 12-week behaviour change intervention, during which time participants met with the researcher weekly and used a pedometer to measure step count and completed an activity diary to monitor progress, set goals and plan how to cope with identified barriers.
15917772|NCT03514199|Other|Mediterranean-type diet|"Recommendations: ingest whole grains; three or more servings/day (various fresh fruits/vegetables); three or more servings/week of fish or seafood; white meat to red and processed meat (red meat to one serving or less/day); oilseed mix - 30g/day (nuts: 15g/day, almonds: 7.5g/day, hazelnuts: 7.5g/day); extra virgin olive oil (30ml/day: 2 soup spoons/day) as the main source of fat in the salads; two or more servings per week of sofrito; two servings/day of low-fat dairy products; limit to one serving/week the intake of fatty and cured cheeses; recommendation of 7 glasses per week of red wine (recommendation for habitual drinkers): 1 cup/day of 100ml for women and 1-2 cups/day of 150ml for men; limit to one serving/week the intake of chocolate with more than 50% cocoa."
15917773|NCT03514199|Other|Low fat diet|Recommendations: choose grilled, cooked, baked or soaked preparations; avoid frying (sweet or salty); avoid excess fat in the preparations and season the foods with herbs at will (marjoram, basil, oregano, onion, green seasoning, sweet pepper, sage, etc.); avoid frequent ingestion of sausages such as ham, turkey breast, among others; avoid eating fatty meats and strip the skin of poultry before preparation; avoid eating sweets and fatty foods; avoid ingesting bakery products, such as leafy, tart, savory pasta.
15917836|NCT03513653|Diagnostic Test|Echocardiography with speckle-tracking imaging|"Measurement of left ventricular ejection fraction and global longitudinal strain
~Measurement of left atrial reservoir strain (peak atrial longitudinal strain)
~Measurement of right ventricular global longitudinal strain"
15918434|NCT03509558|Other|Physical Therapy|physical therapy to improve walking and standing functions
15917774|NCT03514186|Behavioral|Speech and Language Therapy|"Includes:
~one hour of individual therapy using a multimodality treatment called Verb Network Strengthening Treatment (VNeST) that simultaneously targets semantics (word retrieval) and syntax (sentence construction);
~one hour of constraint induced language therapy (CILT) where participants are paired and practice requesting and providing specific information using only spoken language;
~one hour in the computer lab working on programs called Oral Reading for Language in Aphasia (ORLA) and AphasiaScripts; and
~one hour in a conversation group that emphasizes multimodality communication"
15917775|NCT03514173|Device|Remote Patient Monitoring|Use of remote patient monitoring
15917776|NCT03514160|Behavioral|Group exercise|Group exercise based on the American College of Sports Medicine guidelines.
15917777|NCT03514147|Other|Experimental|"Profile of participants: an anamnesis file was used to collect personal data;
~To evaluate the quality of life: To evaluate the quality of life, using International Consultation on Incontinence Questionnaire (ICIQ-Short form) in women with urinary incontinence in baseline and after 12 weeks of intervention;
~To evaluate the pelvic floor muscle functionality: To evaluate the pelvic floor muscle functionality, using PERFECT Scale and Pressure Biofeedback in baseline and after 12 weeks of intervention;"
15917778|NCT03514147|Other|Control|"Profile of participants: an anamnesis file was used to collect personal data;
~To evaluate the quality of life: To evaluate the quality of life, using International Consultation on Incontinence Questionnaire (ICIQ-Short form) in women with urinary incontinence in baseline and after 12 weeks of intervention;
~To evaluate the pelvic floor muscle functionality: To evaluate the pelvic floor muscle functionality, using PERFECT Scale and Pressure Biofeedback in baseline and after 12 weeks of intervention;"
15917779|NCT03514134|Behavioral|Virtual Reality Job Interview Training|Students will engage in didactic training related to strategies to perform well during a job interview as well as repeated practice with a virtual hiring manager. Throughout and after completion of the virtual interviews, participants will receive feedback on their performance.
15917780|NCT03514134|Behavioral|Services as Usual|Study participants will be receiving their community-based or school-based services as usual that may include but is not limited to vocational skill training, daily living skill training, and social skill training.
15917781|NCT03514121|Biological|FPA150|A monoclonal antibody against B7-H4
15917782|NCT03514121|Biological|Pembrolizumab|An anti-PD1 antibody
15917783|NCT03514108|Drug|Hydralazine Isosorbide Dinitrate|Tablet BiDil (Hydralazine 37.5 mg/ Isosorbide Dinitrate (ISDN) 20 mg) 2 tablets x 3 daily
15917784|NCT03514108|Drug|Placebo Oral Tablet|2 tablets x 3 daily
15917785|NCT03514108|Drug|Metformin Hydrochloride|Tablet Metformin hydrochloride 500 mg 2 tablets x 2 daily (eGFR 35-60 ml/min: 500 mg x 2 daily)
15917786|NCT03514108|Drug|Placebo Oral Tablet|2 tablets x 2 daily (eGFR 35-60 ml/min: 500 mg x 2 daily)
15917787|NCT03514095|Other|Individual Cognitive Stimulation Therapy Program|"This program unfolds in 3 weekly sessions of 30 minutes, for 12 weeks, thus completing a total of 36 sessions.
~Over the 3 months, the dyad will need to be monitored for orientation / monitoring of intervention by an element of the research team. This monitoring will be bi-weekly, in person or by phone - here according to the choice of the dyad). After each session the caregiver has a questionnaire to complete (intervention monitoring strategy), with the objective of evaluating the acceptability and applicability of the program."
15917788|NCT03514082|Device|Rigid Thermoplastic Spinal Brace|Custom made rigid thermoplastic brace with 23 hours daily wearing time.
15917789|NCT03514069|Drug|ruxolitinib|Starting dose ruxolitinib 10 mg twice daily
15917790|NCT03514069|Radiation|radiation|60gy for 6 weeks
15917791|NCT03514069|Drug|temozolomide|75mg/m2
15917792|NCT03514056|Diagnostic Test|group 1:Patients diagnosed with Behcet disease|Frequency and severity of fibromyalgia will be investigated in patient diagnosed with Behcet disease
15917793|NCT03514056|Diagnostic Test|group 2: Patient diagnosed with fibromyalgia without Behcet disease|Severity of fibromyalgia will be investigated in patient diagnosed with fibromyalgia
15917794|NCT03514030|Diagnostic Test|serum AQP4-antibody testing method|there are different methods of testing serum AQP4-antibody
15917795|NCT03514017|Drug|Pembrolizumab|Pembrolizumab will be administered intravenously (IV) at 200 mg every 3 weeks for 1 year and up to 2 years.
15917796|NCT03514017|Drug|Ibrutinib|Ibrutinib will be administered orally once daily at approximately the same time each day at the dose of 420 mg daily (3 capsules of 140 mg daily).
15917797|NCT03514004|Behavioral|ICT-based intervention|"The ICT-based intervention, known as Project Clan, includes both a web-platform and a mobile application. Project Clan includes both informational and interactive features, ranging from traditional suicide prevention strategies (e.g., a chat with a psychologist, emergency phone hotline, and tips) that seek to reduce barriers to access quality, useful, and evidence-based information and rapid professional assistance, to components designed to increase interactions between participants and promote a sense of belonging and connection with the other Clan members."
15917798|NCT03513991|Other|Infant formula|
15917799|NCT03513978|Other|IAI Exercises Protocol|Progressive exercises to improve the strength and propioception of the male soccer players.
15917800|NCT03513978|Other|FIFA 11+|"Progressive exercises protocol to prevent injuries in male soccer players which has been created by FIFA. It is based in different body wieght exercises to improve the neuromuscular control and stabilization."
15917801|NCT03513965|Behavioral|Symptoms as Positive Signals Mindset|In this intervention, both arms receive the same strategies for managing symptoms and receive the same level of support regarding symptoms. However, Symptoms as Positive Signals Mindset families are additionally encouraged to think of symptoms as a positive signal that their immune system is becoming increasingly desensitized to their allergen. For each arm, four families (six to seven patients per group) meet monthly for eight months in the clinic with at least two members of the patient support team. These visits are an opportunity for families to harness peer support and ask questions, and include a variety of activities that depict symptoms in different ways.
15917802|NCT03513965|Behavioral|Symptoms as Side Effects Mindset|In this intervention, both arms receive the same strategies for managing symptoms and receive the same level of support regarding symptoms. For each arm, four families (six to seven patients per group) meet monthly for eight months in the clinic with at least two members of the patient support team. These visits are an opportunity for families to harness peer support and ask questions, and include a variety of activities that depict symptoms in different ways.
15917803|NCT03513952|Drug|Atezolizumab|Given IV
15917806|NCT03513939|Combination Product|Sernova Cell Pouch™|The Sernova Cell Pouch™ will be implanted under the skin. A minimum of three weeks after Cell Pouch™ implantation, immunosuppression will be initiated and optimized for another 3 weeks. This will allow for proper vascularization of the Cell Pouch™ chambers and the patient to be stabilized on immunosuppression prior to transplantation. A mass, >3,000 islet equivalent (IEQ) numbers per kg of patient body weight (IEQ/kg), of highly purified islets will be transplanted in the Cell Pouch™.
15917807|NCT03513926|Device|Continuous Positive Airway Pressure|Continuous Positive Airway Pressure
15917808|NCT03513913|Procedure|ICSI|Oocytes are fertilized by conventional in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)
15917809|NCT03513874|Drug|Metformin|Patients will be subscribed with 850mg metformin orally twice daily. Insulin will be continued as routine therapy.
15917810|NCT03513874|Drug|Insulin|Patients will continue insulin therapy following physicians' instructions.
15917811|NCT03513861|Other|FASTER Assessment tool|The FASTER assessment tool consists of monitoring mental status, respiratory distress and capillary refill time by parents of children admitted to the hospital with febrile illness. Parents in the intervention group are asked to monitor their child hourly with the FASTER tool and signal severity of illness to the healthcare team via color coded flag system. Number of healthcare provider - patient reassessments will be compared in intervention and control group.
15917812|NCT03513848|Device|Retimer|The Retimer light device in this study is a commercially-available wearable light device. It permits ambulation while receiving light from LEDs positioned below the eyes. The LEDs emit green light (~500nm, 230 µW/m2, 500 lux), close to the peak sensitivity of circadian photoreceptors.
15917813|NCT03513848|Device|Retimer placebo|The Retimer device has been dimmed to reduce the light intensity to a level that will not shift circadian timing.
15917814|NCT03513835|Diagnostic Test|Diagnostic screenings tests|Handgrip test, 12-minute walk test and 6-minute walk test. Biomarkers: acyl-carnitine profile and GDF-15.
15917815|NCT03513822|Drug|Ketamine 10 MG/ML|Ketamine infusion 1mg/kg with electric syringe during 2 hours.
15917816|NCT03513822|Drug|Placebos|Sodium chloride infusion with the same rate, electric syringe during 2 hours.
15917817|NCT03513822|Drug|Midazolam 1 MG/ML|Bolus of Midazolam 1mg before each perfusion.
15917818|NCT03513809|Device|Thoracic electrical impedance tomography|Non invasive, radiation-free, bedside monitoring tool for distribution of pulmonary ventilation.
15917819|NCT03513783|Other|measurement of human movement|"The objective measurement of human movement through the use of kinematic markers and electromyography is a clinical exam commonly performed to analyze the movements of patients with motor control disorders. The different steps are the following:
~A clinical exam is performed by the Physical Medicine & Rehabilitation clinician (passive range of motion , spasticity, muscular force, etc.).
~Intramuscular and surface electromyography and kinematic markers are placed on the upper limb of the participant. A maximum of two intramuscular electrodes will be inserted with guiding of an echography system.
~The participant will be asked to perform several upper limb movements: specifically, he will be asked to perform consecutive cycles of elbow extension-flexions with the shoulder at different levels of abduction. Times of rest will be given to the participants.
~Time of the procedure is estimated to 1h, with only about 2 minutes of active effortless movements from the participants."
15917820|NCT03513770|Other|Wrist-to-elbow (W-E) occlusion|"An IV will be inserted in the antecubital fossa of one arm. The arm will be fitted with occlusion cuffs arranged in a continuous fashion from the wrist to the elbow. A final cuff will be placed on the upper arm. The cuffs from the wrist to the elbow will be inflated to the same pressure of up to 300 mmHg using a pressurized air tank.
~First, the subject?s arm will be elevated and the subject will make a fist to squeeze blood from the hand. Then the wrist cuff will be inflated. Once that cuff is fully inflated, the next cuff in the sequence will be inflated. Cuffs are inflated in sequence until the elbow cuff is inflated. After a 10-15 second period to allow blood to drain, the upper arm cuff will inflate (up to 250 mmHg) to keep any additional blood from entering the forearm. Next, the cuffs on the forearm will be removed but the upper arm cuff will remain inflated."
15917821|NCT03513770|Drug|ketorolac tromethamine|In the COX blockade trial, just after the Wrist-to-elbow occlusion, 6 mg ketorolac tromethamine in 10 ml saline will be infused into the forearm over 1 minute. After 10 minutes, a second infusion of ketorolac tromethamine (up to 3 mg) in 5% of the forearm volume of saline,( ~40-60 ml) will be infused into the occluded forearm at a rate of ~ 30 ml/min. Five minutes of data will then be collected before releasing the upper arm cuff. Infusion 1 is to block the COX pathway, while infusion 2 is to induce venous distension.
15917822|NCT03513770|Drug|saline control|In the saline control trial performed on a separate day, saline (without ketorolac) in identical volumes as those in the COX blockade trial, will be infused.
15917823|NCT03513757|Drug|propofol|propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists
15917824|NCT03513757|Drug|Dexmedetomidine|single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg
15917825|NCT03513757|Drug|Glycopyrrolate|4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group
15917826|NCT03513757|Drug|Lidocaine 1% Injectable Solution|1 mg/kg intravenous administration prior to propofol administration
15917827|NCT03513757|Drug|Nitrous Oxide|Inhalation of nitrous oxide may be used for IV placement
15917828|NCT03513757|Drug|Sevoflurane|Inhalation of sevoflurane may be used for IV placement
15917829|NCT03513744|Dietary Supplement|human milk oligosaccharides|mixture of five different human milk oligosaccharides
15917830|NCT03513731|Device|Adipose-derived stem cell injection|ADRC injection into the facet joint
15917831|NCT03513731|Drug|Corticosteroid injection|Corticosteroid injection into the facet joint
15917832|NCT03513705|Other|Best practices in pancreatic cancer care|All best practices follow the current state of the Dutch guideline on pancreatic cancer and the literature.
15917833|NCT03513692|Device|Fill-Up composite resin|2 arm study comparing restoration of a tooth with either FillUp composite or conventional composite
15917834|NCT03513679|Procedure|Surgical intervention|Surgery to decompress the spinal cord, either with or without concurrent fusion
15917835|NCT03513666|Combination Product|Drug intervention|anti-PD-1 monoclonal antibody Toripalimab injection combined with Pemetrexed and carboplatin
15917841|NCT03513601|Drug|(R)-CHOP regimen|(rituximab 375mg/m2 d0 ivgtt),cyclophosphamide 750mg/m2 d1、8 ivgtt,epirubicin 50mg/m2 d1、8 ivgtt,vincristine 2mg d1、8 ivgtt,prednisone 60mg d1-5 po.Every 21 days for one cycle and six cycles are required. Efficacy was evaluated every two cycles.
15917842|NCT03513601|Drug|(R)-CVP regimen|The dose of the chemical was reduced by 20%，(rituximab 375mg/m2 d0 ivgtt),cyclophosphamide 750mg/m2 d1、8 ivgtt,vincristine 2mg d1、8 ivgtt,prednisone 60mg d1-5 po.Every 21 days for one cycle and one or two cycles are required. Efficacy was evaluated every two cycles. Subsequent (rituximab 375mg/m2 d0 ivgtt)， oral cyclophosphamide .
15917843|NCT03513588|Drug|Placebo|tablet, 0 mg, 14 days, every 12 hours
15917844|NCT03513588|Drug|PF-06865571|tablet, 50 mg, 14 days, every 12 hours
15917845|NCT03513588|Drug|PF-06865571|tablet, 300 mg, 14 days, every 12 hours
15917846|NCT03513575|Other|Group 1: no intervention|Unstimulated saliva samples are collected from the subject to measure the pH of saliva after 5, 15, 30, 45 and 60 minutes of consumption of the test flavored milk drink without any intervention.
15917847|NCT03513575|Other|Group 2: tap water gargle|The subject will use 10 ml of tap water as mouth rinse to swish for 60 seconds and spit, 15minutes after the subject has consumed the test flavored milk drink. Unstimulated saliva samples are collected from the subject to measure and record the pH of saliva at 15, 30 and 45 minutes after the subject completes the gargle as an intervention.
15917848|NCT03513575|Other|Group 3: 0.2% Chlorhexidine|The subject will use 10 ml of 0.2% Chlorhexidine mouth rinse (Rexidine®, Indoco Remidies Ltd, Mumbai, India) to swish for 60 seconds and spit, 15minutes after the subject has consumed the test flavored milk drink. Unstimulated saliva samples are collected from the subject to measure and record the pH of saliva at 15, 30 and 45 minutes after the subject completes the gargle as an intervention.
15917849|NCT03513575|Other|Group 4: Fluoridated tooth paste|The subject will Brush with fluoridated toothpaste-(Colgate Total®, Colgate-Palmolive Company, Mumbai, India) for 2 minutes using soft brush, 15minutes after the subject has consumed the test flavored milk drink. Unstimulated saliva samples are collected from the subject to measure and record the pH of saliva at 15, 30 and 45 minutes after the subject completes using tooth paste as an intervention.
15917850|NCT03513575|Other|Group 5: Polyol containing gum|The subject will chew polyol containing gum (Orbit®, WrigleyCompany) for 5 minutes and spit, 15minutes after the subject has consumed the test flavored milk drink. Unstimulated saliva samples are collected from the subject to measure and record the pH of saliva at 15, 30 and 45 minutes after the subject completes chewing as an intervention.
15917851|NCT03513575|Other|Group 6: 1% sodium bicarbonate solution|The subject will use 10 ml freshly prepared 1% sodium bicarbonate w/v solution to swish for 60 seconds and spit, 15minutes after the subject has consumed the test flavored milk drink. Unstimulated saliva samples are collected from the subject to measure and record the pH of saliva at 15, 30 and 45 minutes after the subject completes the gargle as an intervention.
15917852|NCT03513562|Drug|Ibrutinib|Given PO
15917853|NCT03513562|Other|Laboratory Biomarker Analysis|Correlative studies
15917854|NCT03513562|Drug|Venetoclax|Given PO
15917855|NCT03513549|Drug|Loxapine 10 MG|
15917856|NCT03513536|Other|Citrus-Based Aromatherapy|This intervention is a blend of plant derived oils which have been distilled from crude plant matter and analyzed in a laboratory to identify chemical composition.
15917857|NCT03513536|Other|Mint-Based Aromatherapy|This intervention is a blend of plant derived oils which have been distilled from crude plant matter and analyzed in a laboratory to identify chemical composition.
15917858|NCT03513536|Other|Spice-Scented Aromatherapy|This intervention is a blend of plant derived oils which have been distilled from crude plant matter and analyzed in a laboratory to identify chemical composition.
15917859|NCT03513536|Other|Control|This control is a blend of plant derived oils which have been expressed from crude plant matter.
15917860|NCT03513523|Dietary Supplement|Group 1 NRPT|Two capsules of NRPT and two placebo will be taken once daily in the morning for 26 weeks. Each NRPT capsule will contain 125 mg NR and 25 mg PT.
15917861|NCT03513523|Dietary Supplement|Group 2 NRPT|Four capsules of NRPT will be taken once daily in the morning for 26 weeks. Each NRPT capsule will contain 125 mg NR and 25 mg PT.
15917862|NCT03513523|Other|Group 3 Placebo|Four placebo capsules will be taken once daily in the morning for 26 weeks.
15917863|NCT03513510|Behavioral|iChoose|
15917864|NCT03513497|Other|Customized acrylic mouthguard|Customized acrylic mouthguards extended to cover approximately 2 mm over gingival margins will be fabricated for each subject. Stents will form a seal and rest on the gingiva, but will be relieved on the tooth and tissue side except for the occlusal surfaces to avoid disturbing plaque or gingival tissues. Acrylic stents will cover the area in one sextant where no brushing and flossing teeth is to occur for 21 days.
15917865|NCT03513484|Drug|Azacitidine|Given IV or SC
15917866|NCT03513484|Other|Laboratory Biomarker Analysis|Correlative studies
15917867|NCT03513484|Drug|Nintedanib|Given PO
15917868|NCT03513471|Biological|Anakinra|A single 1mg/kg subcutaneous injection (up to 100mg) of anakinra will be administered at the onset of the EPR, directly after the allergen challenge, to model anakinra use in an emergency care setting.
15917869|NCT03513471|Other|Anakinra Matching Placebo|A single dose of matching placebo will be administered at the onset of the EPR, directly after the allergen challenge, to model anakinra use in an emergency care setting.
15917870|NCT03513471|Drug|Dermatophagoides Farinae|Standardized house dust mite Dermatophagoides farinae (D. farinae) allergen extract at 30,000 allergen units (AU)/mL for inhalation (provided by Greer Laboratories, Lenoir, NC).
15917871|NCT03513458|Biological|Anakinra|A single 1mg/kg subcutaneous injection (up to 100 mg) of Anakinra will be administered at the onset of the LPR, roughly three hours post allergen challenge, to model Anakinra use in an emergency care setting.
15918037|NCT03512197|Drug|Chemotherapy|Along with the study drug/placebo, chemotherapy will be give as welll: either Daunorubicin or Idarubicin and Cytarabine al take by i.v.
15917872|NCT03513458|Other|Anakinra Matching Placebo|A single dose of matching placebo will be administered at the onset of the LPR, roughly three hours post allergen challenge, to model Anakinra use in an emergency care setting.
15917873|NCT03513458|Drug|Dermatophagoides Farinae|Standardized house dust mite Dermatophagoides farinae (D. farinae) allergen extract at 30,000 allergen units (AU)/mL for inhalation (provided by Greer Laboratories, Lenoir, NC).
15917874|NCT03513445|Drug|Morphine|Morphine, epinephrine, and ropivacaine cocktail will be administered peri-incisionally during lumbar spine surgery.
15917875|NCT03513445|Drug|Epinephrine|Morphine, epinephrine, and ropivacaine cocktail will be administered peri-incisionally during lumbar spine surgery.
15917876|NCT03513445|Drug|naropin|Morphine, epinephrine, and ropivacaine cocktail will be administered peri-incisionally during lumbar spine surgery.
15917877|NCT03513432|Dietary Supplement|Beer with 5.20 % alcohol|330 ml beer (5.20 % alcohol)/day during 4 weeks
15917878|NCT03513432|Dietary Supplement|Non-alcoholic beer with 0.45 % alcohol|330 ml non-alcoholic beer (0.45 % alcohol)/day during 4 weeks
15917879|NCT03513432|Dietary Supplement|Non-alcoholic beer with 0.00 % alcohol|330 ml nonalcoholic beer (0.00 % alcohol)/day during 4 weeks
15917880|NCT03513419|Behavioral|The AMOR Method|The parent resilience training involves a series of eight weekly 90-minute group sessions with up to 8 parents of young children with ASD (4- 10:11 years old) per group, as well as three individual sessions.
15917881|NCT03513406|Drug|Sugammadex|Sugammadex is indicated for the reversal of neuromuscular blockade.
15917882|NCT03513406|Drug|Neostigmine|Neostigmine is indicated for the reversal of neuromuscular blockade.
15917883|NCT03513406|Drug|Glycopyrrolate|Glycopyrrolate is used in conjunction with neostigmine to prevent neostigmine's muscarinic effects.
15917884|NCT03513393|Drug|velpatasvir|Test 1
15917885|NCT03513393|Drug|velpatasvir|Test 2
15917886|NCT03513393|Drug|velpatasvir|Reference
15917887|NCT03513380|Behavioral|Exergaming|free access to the exergame PedalTanks during 6 months
15917888|NCT03513367|Other|Duchenne Muscular Dystrophy of the PedsQL ™ 3.0 scale|"Scaling in multidisciplinary consultations in the form of a self-administered questionnaire with the help of a third party (psychologist). The child and his / her parent complete the questionnaire independently. The result of the questionnaire will then be scored.
~To validate the French translation of the pediatric module of Duchenne Muscular Dystrophy of the PedsQL ™ 3.0 scale. The validation process is confirmatory, the scale being widely used in English. The scale will measure the quality of life of the child using two independent assessments : children and their parents."
15917889|NCT03513367|Other|The following data of motor function|In parallel, the following data are collected on the day of the consultation: assessment of motor function (MFM, use of a wheelchair, age of loss of walking); assessment of respiratory function (EFR, FVC, respiratory assistance, type of respiratory aid); evaluation of cardiac function (FE); assessment of nutritional status (weight, height, BMI, nutritional support by gastrostomy), school status; ongoing drug treatments (corticosteroids, IEC).
15917890|NCT03513354|Other|Soil group|Exercises in soil.
15917891|NCT03513354|Other|Pool group|Exercises in pool.
15917892|NCT03513341|Other|No intervention|No intervention is given to the participants. This is an observational study exploring the students' levels of physical activity and sedentary behaviour in their natural setting.
15917893|NCT03513328|Drug|Thiotepa--single daily dose|Conditioning regimen for hematopoietic stem-cell transplant. Single daily IV dose of Thiotepa at 5 mg/kg.
15917894|NCT03513328|Drug|Thiotepa--escalated dose|Twice daily IV dose of Thiotepa at 5 mg/kg, twelve hours apart, 10mg/kg total.
15917895|NCT03513315|Behavioral|Implementation of Community-based Home Heat Bundle|This community-based intervention include a set of educational materials to increase awareness about heat-related illness and prevention with the intention of reducing the incidence of heat-related and reducing mortality associated with heat-related illness. Materials used in this intervention will include posters, brochures, in-person training, and SMS messaging.
15917896|NCT03513315|Behavioral|Regular Community Healthcare provision|The community will get regular community health workers visit without the focus community mobilization and education on heat-related illnesses.
15917897|NCT03513302|Dietary Supplement|placebo|2 x 70 mL concentrated beet root juice depleted of nitrate per day for 14 days.
15917898|NCT03513302|Dietary Supplement|nitrate|2 x 70 mL concentrated beet root juice per day for 14 days.
15917899|NCT03513289|Other|Patient, Carer, and Clinician Interviews|Post-ICU follow-up interviews conducted over the phone, lasting between 30-60 minutes.
15917900|NCT03513276|Drug|100cc of 2% ropivacaine|Multimodal analgesia + Local infiltration anesthesia
15917901|NCT03513276|Drug|Saline Solution|Multimodal analgesia + Saline solution
15917902|NCT03513276|Drug|Adrenaline 10mcg/ml|
15917903|NCT03513263|Procedure|Scaling and polishing|An electronic scaler will be used to clean the gums
15917904|NCT03513263|Other|oral hygiene instructions|It will include 15-minute oral session with visual and verbal information on how to use a toothbrush, dental floss, and mouthwash correctly; how to clean bridges and dentures; and how and why to use a plaque disclosing test to perform tooth cleaning
15917905|NCT03513250|Drug|hyoscine-n-butylbromide|one ampoule of 20 mg of hyoscine-n-butylbromide (Buscopan, 20mg/Ampoule, CID/Boehringer ) will be administered intravenously immediately before the end of the cesarean section.
15917906|NCT03513250|Drug|control group|an equal volume(1 ml ) of normal saline will be administered before the end of cesarean section.
15917907|NCT03513237|Procedure|Cervical dilation|manual dilatation of the cervix using surgeon's finger.
15917908|NCT03513224|Other|eDosette|The eDosette is an internet-enabled, medication administration monitoring unit that has been previously tested for feasibility in older adults. The eDosette was designed to be compatible with different types of weekly medication blister packs and dosettes, and monitors medication-taking behaviour in a patient's home. The eDosette securely transmits this information to a secure server where the information is converted to individual medication administration records. Patients can also use the eDosette to notify their primary care team of potential medication side effects.
15917909|NCT03513211|Drug|SUBA-itraconazole|150mg PO BD
15917910|NCT03513211|Drug|Hydroxychloroquine|Escalating doses in Rolling 6 Phase I
15918066|NCT03512015|Other|The Lung Cancer App - LuCApp|The Intervention Arm receiving LuCApp (The Lung Cancer App) in addition to standard care
15917911|NCT03513198|Diagnostic Test|Endoscopic ultrasound (including fine needle aspiration)|"EUS will be performed before (including EUS-FNA for confirmation of diagnosis) and 2 months after the first course of treatment.
~Protocol of EUS with EUS-FNA should include linear EUS instruments with complete examinations of the pancreas.
~Tumor characteristics (echogenicity, echostructure, size) will be described as well as presence/absence of power Doppler signals.
~EUS-FNA will be performed in all pancreatic masses with at least four passes."
15917912|NCT03513198|Other|Contrast-enhanced endoscopic ultrasound (CE-EUS)|"CE-EUS will be performed during usual EUS examination before and 2 months after the first course of chemotherapy.
~The starting point of the timer will be considered the moment of intravenous contrast injection (Sonovue 4.8 mL).
~The whole movie (T0-T120s) will be recorded in a DICOM format on the embedded HDD of the ultrasound system, for later analysis.
~All post-processing and computer analysis of digital movies will be performed within the coordinating IT Center using Vue-Box"
15917913|NCT03513198|Other|Endoscopic ultrasound elastography (EG-EUS)|"EUS-EG will be performed during usual EUS examinations, before and 2-months after the first course of chemotherapy, with two movies of 10 seconds recorded on the embedded HDD
~The region of interest for EUS-EG will be preferably larger than the focal mass. If the focal mass is larger than 3 cm, part of the mass will be included in the ROI, as well as the surrounding structures. Very large ROI for the elastography calculations will be avoided
~The following pre-settings will be used in all centers: elastography color map 1, frame rejection 2, noise rejection 2, persistence 3, dynamic rage 4, smoothing 2, blend 50%.
~SR and SH will be measured; with three measurements made and recorded on the embedded HDD."
15917914|NCT03513198|Diagnostic Test|Contrast-enhanced computed tomography (CT)|"Contrast-enhanced computed tomography will be obtained before treatment to assess the local extension of the tumor, and presence of lymph nodes and distant metastases.
~A template will be used to report the imaging results.
~The template includes morphologic, arterial, venous, and extrapancreatic evaluations.
~Contrast-enhanced computed tomography will be performed 2 months after the first course of chemotherapy, using the same template, in order to evaluate the tumor response. Tumor response will be assessed according to the Response Evaluation Criteria in Solid Tumors (RECIST)."
15917915|NCT03513185|Drug|Deanxit, SSRI or SRNI|After recruiting participants and collecting the baseline data, the SSS-CN, PHQ-15, PHQ-9 and GAD-7 questionnaires will be carried out. An independent diagnosis will be made by primary care physician using the fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criterion standard. Deanxit, selective serotonin reuptake inhibitors (SSRI) or serotonin-norepinephrine reuptake inhibitors (SNRI) will be selectively prescribed according to the severity category assessed by physician. Two, 6,10 weeks after patients with correspondent medications, a face-to-face interview, telephone interview or mobile-apps survey will be underwent to follow-up using the SSS-CN, PHQ-15, PHQ-9 and GAD-7 checklists.
15917916|NCT03513172|Drug|topical brimonidine tartrate 0.15% (Alphagan® P; Allergan, Inc)|The rapid hypotensive effects of topical alpha2-agonists such as brimonidine tartrate on decreasing aqueous production and increasing uveoscleral outflow, in addition to their neuroprotective properties, make them an attractive option for prophylactic treatment of post-injection IOP spikes.
15917917|NCT03513159|Behavioral|Pathfinder support|A pathfinder will support the patient with structured activities.
15917918|NCT03513146|Procedure|Oropharyngeal Administration of Mother's Milk (OPAMM)|0.2 ml of own mother's milk will be given by dropper to the oro-pharyngeal pouch, tongue and cheeks and the remaining amount will be given by the regular gavage feeding on intervals and amount regulated by the feeding protocol
15917919|NCT03513133|Behavioral|working memory training|Hierarchical cognitive training of the different components of working memory according to Baddeley model; 15 tasks are used addressing: the phonological loop (8 tasks), the visuospatial sketchpad (4 tasks) and the central executive 3 tasks). Task are given in a hierarchical order, according to each individual patient's deficits and improvement.
15917920|NCT03513107|Other|ospeoporosis score|"Scores will be calculated as indicated in their respective studies after collecting the data pertaining to them (Crandall, 2015); (Cass & Shepherd, 2013); (Reginster, et al., 2004); (Adler, et al., 2003); (Cadarette, et al., 2000); (Weinstein & Ulery, 2000); (Black, et al., 1998); (Lydick, et al., 1998).
~Data will be treated as dichotomous for both DXA T-scores and screening scores (i.e. Osteoporosis (Yes or NO) versus positive/negative score)."
15917921|NCT03513094|Other|Transversus Abdominis Contraction|Participants were educated on how to contract their transversus abdominis (TA) muscle after having a surface EMG biofeedback device placed on their abdomen to provide audible biofeedback. Participants were asked to ambulate while maintaining TA contraction while ambulating at 50% of maximal volitional isometric contraction.
15917922|NCT03513081|Behavioral|Educative session|The experimental group receive nine educational sessions (one per week) about different vegetables and, at lunch time, they are exposed to a different vegetable. If they try it, they will receive a sticker. In each session, researcher will record their preference for the vegetable and the quantity that they consumed in a scale from one to three (1- the child prooved it; 2 - the child repeated it; 3 - the child ate all the quantity). In the end of 9 sessions, all children (experimental and control group) will receive the same salad that they had eaten at baseline and the procedure will be the same: the salad is weighted before and after the consumption of each child to verify the quantity of each one ate.
15917923|NCT03513068|Device|Portable Oxygen Concentrator (POC)|COPD patients prescribed with LTOT will be randomized to receive a portable oxygen concentrator (POC)
15917924|NCT03513055|Other|nurse inject premixed insulin|nurse inject premixed insulin，coaching in the injection technique
15917925|NCT03513042|Radiation|Intensity Modulated Proton Therapy (IMPT) +/- Chemotherapy|"Standard of care:
~IMPT (conventional fractionation [35x1,55/2Gy, 5 fractions/week] or accelerated fractionation [35x1,55/2Gy, 6 fractions/week])
~with or without concurrent cisplatin (100 mg/m2 [d1, d22 and d43] or 40 mg/m2 weekly) or cetuximab (weekly 400 mg/m2 in 2h followed by 250 mg/m2 in 1h)"
15917926|NCT03513029|Device|VytronUS Ablation System|Catheter Ablation for Paroxysmal Atrial Fibrillation
15917927|NCT03513016|Drug|UBX0101|Investigational drug intra-articular injection
15917928|NCT03513016|Other|Placebo|Diluent intra-articular injection
15917929|NCT03513003|Device|Functional Pacifier|Children swap from their habitual pacifier to the functional pacifier and stop baby bottle
15917930|NCT03513003|Behavioral|Stop habit|Children stop the use of their pacifier and/or baby bottle
15917931|NCT03512990|Procedure|Bupivacaine - Superior Trunk Block|It will be performed the superior trunk approach with local anesthestic in patients and methylene blue in cadavers.
15917932|NCT03512977|Procedure|sphenopalatine ganglion block|the intervention will be performed on sitting position. Lidocaine 2% viscous (0.5ml) will be apply on cotton swab sticks and one will be gently inserted into nostril, along the floor of the nose. Stick will be used to insert it as far as it goes with the intention to reach the nasopharyngeal wall (posterior wall of the nose). At that position the swab stick will be left undisturbed for 20 minutes.
15917933|NCT03512977|Drug|conservative treatment|Conservative treatments are iv hydration, analgesic agents, caffeine or theophylline
15917934|NCT03512964|Drug|dolutegravir and descovy|Patients newly diagnosed with HIV or previously diagnosed with HIV and not on treatment or in care for at least six months will be given antiretroviral therapy starter packs containing dolutegravir (tivicay) 50 mg 1 tablet by mouth daily and emtricitabine 200 mg/tenofovir alafenamide 25 mg (descovy). Number of doses dispensed will be determined by the prescribing provider. Pill boxes will be given with each starter pack. At each clinic, patients are provided with 24/7 clinic contact information should he/she experience adverse side effects to medication and/or experience a medical emergency.
15917935|NCT03512951|Other|Digital signal processing algorithms|The intervention consists in applying five processing on some recorded speech signals. In particular, the processing performed by one specific algorithm is compared against the four other. The applied processing is supposed to restore sound externalization (expected audio-visual fusion).
15917936|NCT03512938|Procedure|Non-surgical periodontal therapy|Patients were motivated and instructed to brush with modified Bass technique and use interdental toothbrushes, dental floss. Each patient underwent quadrant scaling and root planning (SRP) under local anaesthesia over a 4-week period. Root planing (RP) was performed under local anaesthesia (2% lidocaine, epinephrine 1:100.000) and a standard curette set newly sharpened with Arkansas stone was used for each patient.
15917937|NCT03512925|Other|Standardized debriefing session of coercive measures|Debriefing session following the developed guidelines including setting and themes.
15917938|NCT03512912|Device|transcutaneous electrical calf muscle stimulation + supervised walking therapy|transcutaneous electrical calf muscle stimulation + supervised walking therapy
15917939|NCT03512899|Procedure|Right internal jugular access.|Implantation using percutaneous puncture.
15917940|NCT03512899|Procedure|Left internal jugular access.|Implantation using percutaneous puncture.
15917941|NCT03512899|Procedure|Right axillary vein access.|Implantation using percutaneous puncture.
15917942|NCT03512899|Procedure|Left axillary vein access.|Implantation using percutaneous puncture.
15917943|NCT03512886|Other|Multi-task training|In the multitasking training group, a second motor task in the first two weeks, a cognitive task in the third and fourth week, both motor and cognitive tasks in the last two weeks will be added to these 10 different motor tasks.
15917944|NCT03512886|Other|Single task training|An exercise program consisting of 10 different motor tasks will be implemented in a single task training group.
15917945|NCT03512873|Drug|Tranilast|Subjects will be treated with tranilast
15917946|NCT03512860|Drug|E4/DRSP|Administered as specified in the treatment arm.
15917947|NCT03512860|Drug|VAL|Administered as specified in the treatment arm.
15917948|NCT03512834|Drug|Avelumab|Avelumab 10mg/kg, administered via I.V infusion over 1hour, every 2weeks until disease progression or unacceptable toxicity
15917949|NCT03512834|Drug|Paclitaxel|Paclitaxel 80mg/m2 D1,8 and 15 , administered via I.V infusion, every 4 weeks.
15917950|NCT03512821|Drug|Ursodiol 500 MG|Ursodiol 500mg tablets followed by Urso Forte 500mg tablets
15917951|NCT03512821|Drug|Urso Forte 500Mg Tablet|Urso forte 500mg tablets followed by Ursodiol 500mg tablets
15917952|NCT03512808|Drug|Ursodiol 500 MG|Ursodiol 500mg tablets followed by Urso Forte 500mg tablets
15917953|NCT03512808|Drug|Urso Forte 500Mg Tablet|Urso forte 500mg tablets followed by Ursodiol 500mg tablets
15917954|NCT03512795|Biological|Blood samples|An additional blood tube will be taken during the patient's follow-up blood collection.
15917955|NCT03512782|Other|CARDIOENF|The patients listed in interventional group will have access to software Cardioenf that is a app used in a device (cel phone, tablet) to monitoring signs and symptoms of the heart failure patients after discharge from hospital. In this software, their signs and symptoms will be inserted in three moments during the first 30 days after discharge. Nurses will monitor these data in the follow-up period.
15917956|NCT03512769|Device|Restful Jaw Device|The Restful Jaw device is used to support the jaw during dental procedures including surgical removal of 3rd molars (wisdom teeth) with sedation. The device is designed to counter the downward forces placed on the mandible by clinicians during dental procedures and prevent jaw hyperextension (opening too wide) while providing a secure, stable jaw position. When 3rd molar teeth are surgically removed with sedation, a dental assistant stands behind the dental chair and supports the patient's jaw with both hands under the patient's jaw. If needed, the dental assistant also holds the jaw in a slightly forward position to maintain an open airway. This device replicates the dental assistant in holding the jaw during dental procedures.
15917957|NCT03512756|Drug|SM-88 used with MPS (methoxsalen, phenytoin, sirolimus)|Daily oral therapy for cancer
15917958|NCT03512756|Drug|Capecitabine, Gemcitabine, and 5-FU|"Investigator choice of the following therapies:
~Capecitabine, Gemcitabine, and 5-FU"
15917959|NCT03512730|Device|Titanium brush|a titanium brush will be tested as mechanical decontamination in regenerative treatment of peri-implantitis
15917960|NCT03512730|Other|Classic decontamination|Classic decontamination will be performed by means of H2O2 3% and plastic curettes
15917961|NCT03512717|Device|Potenfill|Maximum: 22ml
15917962|NCT03512717|Device|Powerfill|Maximum: 22ml
15917963|NCT03512704|Other|Collection of possible predictors from patient data|Collection of sociodemographic and clinical parameters, from medical records, and health related quality of life data, that may predict the outcomes of interest (mortality, complications, readmissions)
15917964|NCT03512691|Behavioral|Information on CVD Risk|Respondents will be provided three types of information on CVD risks: a CVD base rate, a personalized CVD risk and an optimal CVD risk. The CVD base rate will be predicted from the respondent's age and sex only. After reporting their own chance of having a heart attack or stroke within ten years, the respondents in the treatment group will be told the risk for someone with the same age, sex, smoking status, body mass index (BMI) and blood pressure as them. Finally, a treatment group respondent will receive information on what the 10-year CVD risk would be for someone of the same age and gender who did not smoke, and had normal blood pressure and BMI.
15917965|NCT03512691|Behavioral|Lottery Incentive|Respondents will simply be told that they can enter a lottery if they go to the specified clinic for a checkup. The health facilities will be told to conduct an assessment deemed appropriate for any particular patient that requests to be issued with a lottery ticket. No instructions will be given that the facilities should follow the PhilPEN protocol. We will evaluate whether they do implement the protocol for patients who qualify (by age if nothing else) for full risk screening.
15917966|NCT03512665|Dietary Supplement|Full dose supplement|A 7ml vial composed of a mixture of pine, macadamia and pomegranate oils.
15917967|NCT03512665|Dietary Supplement|Low dose Supplement|A 7 mL vial composed of a mixture containing 50% study supplement (Pine, macadamia and pomegranate oils) and 50% sunflower oil.
15917968|NCT03512665|Other|Control Oil|A 7ml vial composed of sunflower oil with appearance and organoleptic properties similar to those of the supplement provided in the intervention groups.
15917969|NCT03512652|Device|Patello|The Patello is a new intervention device which mobilizes the Patella passively and continuously in cranial-caudal direction to increase Patella mobility.
15917970|NCT03512639|Drug|Homeopathic Medication|Homeopathic medication (Arnica montana and the Bellis perennis) were given to women in the study group following mastectomy and reconstruction to reduce post operative seroma
15917971|NCT03512639|Drug|Placebo|placebo was given to women in the control group following mastectomy and reconstruction to reduce post operative seroma
15917972|NCT03512626|Device|OptiVis, Aaren Scientific|All the surgeries were performed under topical anesthesia using a standard phacoemulsification procedure with Infiniti Vision System (all from Alcon Laboratories, Inc, Fort Worth, TX).
15917973|NCT03512626|Device|Monofocal IOL|All the surgeries were performed under topical anesthesia using a standard phacoemulsification procedure with Infiniti Vision System (all from Alcon Laboratories, Inc, Fort Worth, TX).
15917974|NCT03512613|Device|c-FLOW 3310-P|"c-FLOW 3310-P is a continuous, non-invasive monitor of cerebral deep tissue blood flow used to measure relative changes in blood flow.
~The device monitors regional micro circulatory blood flow in tissues, by using sensors placed near the area of interest."
15917975|NCT03512600|Dietary Supplement|Intervention 0|Without nutritional intervention, it will consist of normal food intake without food derived from cocoa or coffee for a period of 1 day in the group of 20 patients during meals. ( That day the patient can not consume cocoa derivates nor coffe or coffe derivates).
15917976|NCT03512600|Dietary Supplement|Intervention 1|"The nutritional intervention will consist of the intake of 40 g daily a base of food derived from cocoa that will be provided to the paient (Food based on soluble cocoa) during one 1 day period in the group of 20 patients during meals.
~That day the patient can not consume cocoa derivates nor coffe or coffe derivates exept the one provided."
15917977|NCT03512600|Dietary Supplement|Intervention 2|"The nutritional intervention will consist of the intake of 40 g daily a base of food derived from cacao (Food based on black chocolate) during a period of 1 day in the group of 20 patients during meals.
~That day the patient can not consume cocoa derivates nor coffe or coffe derivates exept the one provided."
15917978|NCT03512600|Dietary Supplement|Intervention 3|"The nutritional intervention will consist of the intake of 40 g daily a base of food derived from cocoa (Food based on chocolate with milk) for a period of 1 day in the group of 20 patients during meals.
~That day the patient can not consume cocoa derivates nor coffe or coffe derivates exept the one provided."
15917979|NCT03512587|Procedure|Personalized quantum sonotherapy|Quantum sonotherapy is an alternative non-pharmacological treatment that effects a molecular reorganization that occurs after the sound stimulus. The audible words and their waves have the ability to generate vibrations and stimulate the psycho-neuro-endocrine chain, independent of the semantic meaning of the words. It is an alternative therapy that uses non-musical sound waves.
15917980|NCT03512587|Procedure|Placebo|Headphones will be place in patients without playing quantum sonotherapy
15917981|NCT03512574|Drug|Pregabalin|One hour before spinal anesthesia, patients received pregabalin 150 mg capsule orally and the same calculated volume of normal saline till completion of the surgery
15917982|NCT03512574|Drug|Dexmedetomidine|One hour before spinal anesthesia, patients received placebo and a bolus dose of 0.5 μg /kg IV dexmedetomidine was given over 10 min before induction of spinal anesthesia, a bolus dose of 0.5 μg /kg IV till completion of the surgery
15917983|NCT03512574|Other|Placebo|One hour before spinal anesthesia, patients received placebo and the same calculated volume of normal saline till completion of the surgery
15917984|NCT03512574|Drug|Pregabalin and dexmedetomidine|One hour before spinal anesthesia, patients received pregabalin 150 mg orally and a bolus dose of 0.5 μg /kg IV dexmedetomidine was given over 10 min before induction of spinal anesthesia, a bolus dose of 0.5 μg /kg IV till completion of the surgery.
15917985|NCT03512548|Drug|Relacorilant 350mg|Relacorilant 350mg
15917986|NCT03512548|Drug|Itraconazole|Itraconazole 200 mg
15917987|NCT03512548|Drug|Relacorilant 300mg|Relacorilant 300mg
15917988|NCT03512522|Behavioral|Online Group|An 8-week remotely-delivered pain self-management program tailored to older adults that will be delivered in an online format.
15917989|NCT03512522|Behavioral|Workbook Group|An 8-week remotely-delivered pain self-management program tailored to older adults that will be delivered in a printed (workbook) format.
15917990|NCT03512509|Other|Low glycaemic potato|The Carisma potato variety is used as the low glycaemic index potato.
15917991|NCT03512509|Other|High glycaemic potato|The Arizona potato variety is used as the high glycaemic index potato.
15917992|NCT03512496|Dietary Supplement|Acute energy drink - Placebo|Colored water
15917993|NCT03512496|Dietary Supplement|Acute energy drink - Caffein|Sugar free energy drink at 5mg/kg caffeine
15917994|NCT03512496|Dietary Supplement|Acute energy drink - Decaf|Sugar free decaf energy drink (vitamins only)
15917995|NCT03512483|Behavioral|Virtual Atrial Fibrillation Clinic|Participants in the intervention group will receive usual GP care plus the vAFC which consists of telehealth appointments with Nurse Practitioner/Cardiologist and access to an AF specific educational website. It is anticipated the vAFC, as with the onsite clinic, will include a maximum of four scheduled telehealth appointments: an initial appointment following randomization, at 4-6 weeks, 3 months, and 6 months.
15918131|NCT03511521|Drug|NPH Insulin|Intermediate acting insulin
15918132|NCT03511521|Drug|glargine|basal insulin
15918133|NCT03511521|Drug|Insulin Aspart|prandial insulin
15917996|NCT03512470|Device|Sistema Prevena ™(TVAC)|The medications with a negative topical pressure system (Sistema Prevena ™) will be applied directly in the Operating Room. Thereafter medication will be checked in the inpatient ward after 48 h from the intervention, evaluating the possible absorption of exudate on the surface. If no absorption are detected within 48 hours, the medication won't be removed and renewed in the 7th day (± 2 days) post-operative; and to follow every 7 (± 2 days) until the points are removed. If the wound continues to progress towards recovery, the protocol will continue until discharge and / or rehabilitation and / or surgery.
15917997|NCT03512470|Other|Standard medication|standard medication in use (sterile gauze and TNT patch or medicated patches).
15917998|NCT03512457|Behavioral|Minimal Intervention|Women view an educational poster in changing room, and they receive a brochure.
15917999|NCT03512457|Behavioral|Intensive Intervention|Women view an educational poster in changing room, and they receive a brochure.
15918000|NCT03512444|Device|Negative Pressure System|Negative Pressure System is a non-invasive system that applies sub-atmospheric(Negative) pressure, through a foam and an air-tight film dressing which is connected by suction tubes to a controller unit by which the primary negative pressure can be adjusted.
15918001|NCT03512431|Diagnostic Test|Micro sampling|Compare finger prick micro samples with venous blood samples for measuring whole blood tacrolimus concentrations
15918002|NCT03512418|Behavioral|PrEPsteps|Smartphone-based adherence intervention based in 1) LifeSteps, 2) Contingent Reinforcement/Corrective Feedback, and 3) Screening Brief Intervention and Referral to Treatment (SBIRT).
15918003|NCT03512418|Device|Digital pill|The digital pill comprises a standard gelatin capsule with an integrated radiofrequency emitter that overencapsulates the desired medication (Truvada). When participants ingest the digital pill, the chloride ion gradient in the stomach activates the radiofrequency emitter which transmits direct evidence of medication ingestion to a wearable reader which relays this data to the participant's smartphone and cloud server.
15918004|NCT03512418|Drug|Truvada|Participants receive once daily Truvada as PrEP to prevent HIV.
15918005|NCT03512405|Biological|Blinatumomab|Given IV
15918006|NCT03512405|Other|Laboratory Biomarker Analysis|Correlative studies
15918007|NCT03512405|Biological|Pembrolizumab|Given IV
15918008|NCT03512392|Other|Conservative fluid and deresuscitation strategy|Conservative administration of intravenous fluid and active deresuscitation using diuretics or renal replacement therapy for eligible patients
15918009|NCT03512392|Other|Usual care strategy|Usual care at the discretion of the clinical team
15918010|NCT03512379|Device|TIANJI Robot|A robotic system for spinal surgery
15918011|NCT03512379|Device|Fluoroscopy|For fluoroscopy-based free hand surgery
15918012|NCT03512379|Device|Navigation|For navigation-assisted spinal surgery
15918013|NCT03512366|Procedure|Desarda's technique|It will be performed by separating a strip from the upper leaf of the external oblique aponeurosis in continuity with the muscle and suturing it with the inguinal ligament below and the newly formed upper leaf of EOA above behind the spermatic cord to form the new inguinal floor. This strip will be put under tension by muscular contraction and works as a shield to prevent recurrence.
15918014|NCT03512366|Procedure|Lichtenstein's technique|A 6 × 11 cm polypropylene mesh will be fashioned to fit the posterior wall of the inguinal canal and sutured to the fibro-periosteum of the pubic bone and continued laterally, suturing the inferior edge of the mesh to the shelving edge of the inguinal ligament to a point 2 cm lateral to the internal ring.
15918015|NCT03512353|Drug|Dexamethasone|Dexamethasone will be taken orally or by IV infusion at a dose of 20 mg once-daily on days 1, 2, 8, 9, 15, 16, 22, and 23 of cycles 1-6, and at a dose 40 mg once-daily on days 1, 8, 15 of cycles 7-12.
15918016|NCT03512353|Drug|Carfilzomib|Carfilzomib will be administered at 20 mg/m² on days 1 and 2 of the first cycle. After that, carfilzomib will be administered at 56 mg/m² on days 8, 9, 15, and 16 of the first cycle, and then on days 1, 2, 8, 9, 15, and 16 on each 28-day cycle for the cycles 2 through 6. Starting with cycle 7 through cycle 12, carfilzomib will be administered at 70 mg/m² on days 1, 8, and 15 of each 28-day cycle. All
15918017|NCT03512340|Drug|SRF231|SRF231 specifically blocks the interaction between CD47 and signal regulatory protein alpha and acts as a potent enhancer of human tumor cell phagocytosis.
15918018|NCT03512327|Other|Autoimmune protocol (AIP) diet|Autoimmune protocol diet, designed as a 6 week step wise elimination phase followed by 5 week maintenance phase.
15918019|NCT03512314|Drug|Tadekinig alfa|Open label, 26 weeks on Tadekinig alfa treatment.
15918020|NCT03512301|Device|CAMCI|CAMCI battery of computerized tasks
15918021|NCT03512288|Biological|Multivalent|Pneumococcal conjugate vaccine
15918022|NCT03512288|Biological|13vPnC|Pneumococcal conjugate vaccine
15918023|NCT03512275|Drug|Bermekimab Monoclonal Antibody 400 mg|subcutaneous injection
15918024|NCT03512262|Drug|Abaloparatide|Abaloparatide 80 mcg subcutaneous daily
15918025|NCT03512262|Drug|Placebo|Placebo 0 mcg subcutaneous daily
15918026|NCT03512249|Biological|H56:IC31|5ug H56/500 nmol IC31
15918027|NCT03512249|Biological|Placebo|Sterile saline for injection
15918028|NCT03512236|Drug|BC Pram Ins|Injection of BC Pram Ins
15918029|NCT03512236|Drug|Symlin® and Humulin®|Injection of pramlintide and human insulin
15918030|NCT03512236|Drug|Humalog®|Injection of lispro
15918031|NCT03512236|Drug|Placebo|Injection of 0.9% NaCl
15918033|NCT03512210|Drug|Sofosbuvir/Velpatasvir (SOF/VEL)|400/100 mg fixed-dose combination (FDC) tablet administered orally once daily with or without food.
15918034|NCT03512210|Other|Minimal Monitoring (MINMON) Strategy|"MINMON Strategy:
~No pre-treatment HCV genotyping
~Entire treatment course (84) tablets of SOF/VEL administered to participants at study entry
~No scheduled on-treatment laboratory monitoring or clinic visits
~Remote contact with participants at week 4 and week 22"
15918035|NCT03512197|Drug|Midostaurin|After randomization, patients will receive midostaurin twice daily until not achieving CR nor CRi, relapse after CR or CRi, intolerable toxicity, or consent withdrawal
15918036|NCT03512197|Drug|Midostaurin Placebo|After randomization, patients will receive midostaurin placebo twice daily until not achieving CR nor CRi, relapse after CR or CRi, intolerable toxicity, or consent withdrawal
15918504|NCT03509012|Radiation|External beam radiation (dose level 1)|radiation therapy
15918038|NCT03512184|Behavioral|YMCA class|The Gastroenterologists of Weill Cornell Medical College that are associated with this trial want to implement the YMCA's DPP in the NAFLD population as a structured lifestyle modification/educational intervention. The hypothesis is that the NAFLD patients who complete the YMCA's DPP will also have weight loss and improvement in hepatic steatosis. Importantly, positive results in this New York City-based pilot study would provide a strong rationale for determining whether such a program could be useful to treat NAFLD at established YMCA DPP sites across the country.
15918039|NCT03512171|Drug|Dextroamphetamine|One oral dose of dextroamphetamine (0.43mg/kg). The amphetamine is given in order to induce the release of their own dopamine for study with positron emission tomography (PET).
15918040|NCT03512171|Drug|Placebo|One oral dose of placebo to estimate D2 receptor levels at baseline with PET imaging (necessary to calculate dopamine release in the amphetamine condition).
15918041|NCT03512171|Diagnostic Test|[18F]Fallypride|Radioligand for measuring dopamine D2 receptors with positron emission tomography (PET)
15918042|NCT03512171|Diagnostic Test|[18F]-FE-PE2I|Radioligand for measuring dopamine transporters with positron emission tomography (PET)
15918043|NCT03512158|Other|Non-invasive respiratory support mode|A mode of providing respiratory support via nasal masks or prongs
15918044|NCT03512145|Device|VIPUN Balloon Catheter|Gastric motility is recorded continuously with the VIPUN Balloon Catheter for 10 hours.
15918045|NCT03512132|Biological|Blood samples|5 EDTA tubes of 7ml and 1 dry tube of 7 ml taken on an empty stomach
15918046|NCT03512132|Biological|Urine sample|Urine sample on an empty stomach
15918047|NCT03512119|Drug|Lumacaftor-Ivacaftor treatment|Lumacaftor-Ivacaftor treatment during one year
15918048|NCT03512106|Other|Acupuncture|Chinese traditional acupuncture
15918049|NCT03512093|Other|Retrospective chart review|A retrospective chart review of preterm neonates born in one of the birthing SMRU unit between January 2008 and December 2017 and for whom a medical chart is available. In addition we propose to analyze the growth trajectory, the prevalence of anemia (Hct < 33%) and the level of neurodevelopment achieved in the first year of life reported in the clinical charts of preterm neonates born < 34+0 weeks of gestation.
15918050|NCT03512093|Other|Focus Group Discussion (FGD) of the medical staff|Focus Group Discussion (FGD) of the medical staff working in the SCBU firstly on the benefits and difficulties in using existing guidelines for preterm care and secondly on the feasibility and acceptability of changes in the guidelines 3-6 months after their implementation.
15918051|NCT03512093|Other|Interviews of mothers|Interviews of mothers who delivered preterm neonates (< 37+0 weeks of gestation) to understand the challenges they faced while caring for their child.
15918052|NCT03512067|Device|Patients given EMV Ventilation|Baseline mechanical ventilation data with conventional pressure-limited assist/control ventilation mode will then be collected for a 4-hour period. The patients will then be transitioned to pressure-limited entrainment-based ventilation for a 4-hour period. Baseline ventilation monitoring will be carried out either immediately preceding or immediately following EMV in the same patient. The sequence of the control/baseline phase and the experimental phase of the study will be randomized.
15918053|NCT03512054|Procedure|Standardized 5-step weaning procedure|"Weaning process in 5 steps (0-4), by a multi-professional team (neurosurgeon, physiotherapist, nurse, caregiver…) Stability criteria are defined for each person, after validation pass the next step. Stability criteria degradation return to the previous step. Weaning process can take back after stability criteria renormalization.
~Step 0: cuff deflate. Step 1: occlusion test. Steps 0 and 1 can assess the freedom and protect capacity airway. In failure process, we can propose a nasofibroscopy.
~Step 2: Phonatory Valve. Respiratory rehabilitation/ swallowing, limiting breathing effort. The valve ought to stay 12 hours before going to the step 3.
~Step 3: Plug. Finish the Respiratory rehabilitation/ swallowing. The plug ought to stay 24hours minimum before going to the step 4.
~Step 4: Decannulation"
15918054|NCT03512041|Behavioral|RLIC - 5 cycles|RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays.
15918055|NCT03512041|Behavioral|RLIC - 4 Cycles|RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays.
15918056|NCT03512041|Behavioral|RLIC - 3 Cycles|RLIC is achieved as listed in the arm/group descriptions. RLIC is performed on visits 1-7, which occur on consecutive weekdays.
15918057|NCT03512041|Behavioral|Sham conditioning|Sham conditioning is achieved as listed in the arm/group descriptions. Sham conditioning is performed on visits 1-7, which occur on consecutive weekdays.
15918058|NCT03512041|Behavioral|Balance training|All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-7.
15918059|NCT03512041|Behavioral|Arm training|All participants undergo training on a cup stacking task, learning to assemble and disassemble cup configurations as fast as they can. Participants perform the cup stacking task 5 trials per day at visits 3-7.
15918060|NCT03512041|Behavioral|Sequence production training|All participants undergo training on a discrete sequence production task. Participants learn to associate specific color and shape symbols with sequences of key presses on a keyboard. Participants perform the sequence production task for 10-15 minutes per day at visits 3-7.
15918061|NCT03512028|Behavioral|RLIC|See descriptions under arm/group descriptions. RLIC is delivered for 8 visits. Visits 1-3 occur on consecutive work days and visits 4-8 occur on alternating week days.
15918062|NCT03512028|Behavioral|Sham conditioning|See descriptions under arm/group descriptions. Sham conditioning is delivered for 8 visits. Visits 1-3 occur on consecutive work days and visits 4-8 occur on alternating week days.
15918063|NCT03512028|Behavioral|Muscle strength training|All participants undergo muscle strength training of the wrist extensor muscles on one side. Strength training follows standard American College of Sports Medicine guidelines for frequency, intensity, progression etc. Strength training is provided at visits 3-8
15918064|NCT03512028|Behavioral|Driving training|All participants undergo training of a complex cognitive-motor task using a driving simulator. Participants learn to 'drive' on a virtual course, maximizing speed and minimizing errors. Participants perform the driving task once each day for visits 3-8.
15918065|NCT03512028|Behavioral|Balance training|All participants undergo training on a balance board, learning to hold the board level with equal weight on each leg. Participants perform the balance task for 15, 30-second trials per day at visits 3-8.
15918067|NCT03512015|Other|Standard care|The Standard-of-Care patients receiving following the same schedule identified for LuCApp patients with paper questionnaires during clinic visits, or at home (having received paper questionnaires during the previous visit) or via telephonic interviews with the research team.
15918068|NCT03512002|Device|HIRREM|Technology
15918069|NCT03512002|Other|Continued Current Care|Continue their current clinical care.
15918070|NCT03511989|Device|Bone borne distractor|Bone borne distraction device
15918071|NCT03511989|Device|Tooth borne distractor|Tooth borne distraction device
15918072|NCT03511989|Procedure|Segmental LF1 Osteotomy group 1|
15918073|NCT03511989|Procedure|Segmental LF1 Osteotomy group 2|
15918074|NCT03511989|Procedure|Segmental LF1 Osteotomy group 3|
15918075|NCT03511976|Behavioral|Tier 1 Classroom Management|The primary teacher for each participating student will receive consultation related to implementing Tier I management strategies at a classroom level for all students including the target child (see Appendix C). Consultation will be provided by trained study personnel and the strategies will be implemented by the general education teacher (i.e., the end user of the intervention)
15918076|NCT03511976|Behavioral|Daily Report Card (DRC)|Students in the RTI DRC condition will receive Tier II strategies, namely an individualized DRC. Behavioral consultants will meet with teachers to identify appropriate behavioral targets and establish a DRC according to established protocol (see our website for an example http://ccf.fiu.edu/for-families/resources-for-parents/printable- information/). Consultants will also meet with parents to develop a plan for reinforcing the DRC at home using a hierarchical menu of rewards/privileges that will be provided contingent on meeting daily goals.
15918077|NCT03511976|Behavioral|Enhanced DRC (DRC-E)|"In this condition, students who did not show sufficient response to the Phase 1 DRC will receive additional and more intensive Tier II supports.
~Following student assignment to RTI-E, the teacher will have meet with one of the consultants to complete a functional behavior analysis (FBA) to identify remaining target behaviors and ascertain their function. The consultant and teacher will then use the completed FBA to develop a treatment plan for an enhanced DRC (DRC-E).
~Tier II enhancements will be chosen to directly map on to the functions of the target behaviors as outlined in the FBA."
15918078|NCT03511976|Drug|Stimulant|Students will receive either a long-acting methylphenidate preparation or a long-acting mixed amphetamine salts preparation based on parent consultation with the study physician. The prescribed medication will be taken daily.
15918079|NCT03511963|Drug|HLX04 100 mg in 4 ml Injection|7.5 mg/kg iv (XELOX+HLX04) 5 mg/kg iv (mFOLFOX6 + HLX04)
15918080|NCT03511963|Drug|Avastin 100 mg in 4 ml Injection|7.5 mg/kg iv (XELOX+HLX04) 5 mg/kg iv (mFOLFOX6 + HLX04)
15918081|NCT03511937|Behavioral|Sugar-Sweetened Beverage Health Warning Label|Labels with a health warning will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the text and design of these labels based on previous research and on designs described in US and international legislation.
15918082|NCT03511937|Other|Neutral Label|Neutral labels will be applied to the front-of-package of all sugar-sweetened beverage containers in the mock store. Investigators developed the design of these labels.
15918083|NCT03511924|Behavioral|Intradialytic resistance training|Progressive resistance training programme performed during haemodialysis, taking into account subject´s medical review summarizing: A. full medical history, B. clinical examination including cardiovascular assessment, C. detailed medication usage history, D. review of recent biochemistry and haematology records and results of lower extremity muscle strength assessments. Construction of intradialytic training programme followed recommendations published by the Exercise & Sports Science Australia (Smart et al., 2013).
15918084|NCT03511911|Diagnostic Test|evaluation of pelvic floor muscle function through the PHENIX instrument|the PHENIX instrument was designed and produced for sensing muscle activity with surface electrodes, pressure probes and external captors,so it could test biological signals of pelvic floor muscle in human body.
15918085|NCT03511911|Diagnostic Test|vaginal palpation|vaginal palpation is based on modified Oxford Grading Scale(MOS) and Levator ani testing(LAT) to test patients' pelvic muscle strength
15918086|NCT03511898|Drug|THR-149 dose level 1|single intravitreal injection of THR-149 dose level 1
15918087|NCT03511898|Drug|THR-149 dose level 2|single intravitreal injection of THR-149 dose level 2
15918088|NCT03511898|Drug|THR-149 dose level 3|single intravitreal injection of THR-149 dose level 3
15918089|NCT03511885|Other|There is no intervention|
15918090|NCT03511872|Other|Basic life support training|"A course design was made to be consistent with ERC guidelines with local modifications made by emergency professionals in duration, instructor-to-trainee ratio, course materials, methods to deliver these materials theoretically, and the type of the manikin used to practice CPR. One-day-course consisting of 75, 20, 20, 20 minutes for theoretical BLS, chocking, recovery position, the practical representation of BLS scenario respectively followed by 40-minute practical training on BLS skills for each subgroup. Both arms of the study follow the same timeline and no extra time is given to any group.
~Same manikins were used for the training and the assessment. On the day of the experiment students in each arm are divided into 4 subgroups of maximum 9 students, each led by two trainers of BLS skills with a maximum ratio of 2 instructors to 9 students per group."
15918091|NCT03511846|Drug|Oral capsaicin|Subjects will drink a solution with capsaicin
15918092|NCT03511846|Drug|Topical capsaicin|Capsaicin cream will be applied to the skin of the forehead, cheek, or leg
15918093|NCT03511846|Drug|Intranasal capsaicin|Capsaicin cream will be applied to the nostril
15918094|NCT03511846|Other|Cold Water Irrigation|Subjects will be asked to drink up to 2000 ml of cold water or ice water (temperature 0-10 degrees Celsius) as fast as possible, either continuously or intermittently (i.e. 200-800 ml at a time)
15918095|NCT03511846|Other|Medical Air|Subjects will be exposed to medical air
15918096|NCT03511846|Drug|Low Flow Oxygen|Subjects will be exposed to oxygen gas between 1-9 L/min
15918097|NCT03511846|Drug|High Flow Oxygen|Subjects will be exposed to oxygen gas between 10-25 L/min
15918098|NCT03511833|Drug|Morphine|IV morphine -0.1 mg/kg: Morphine vial contains 10 mg/10 ml = 1mg/ml ----> 0.1 ml/kg
15918099|NCT03511833|Drug|Ketamine|IN ketamine: 1 mg/kg: Ketamine vial contains 100 mg/2 ml = 50mg/ml ---> 0.02ml/kg
15918205|NCT03511118|Other|Hydroxyurea|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15918100|NCT03511820|Drug|Lipo-AB® (amphotericin B) liposome|"Name: Lipo-AB® (amphotericin B) liposome for injection
~Dosage form: Lyophilized powder 50 mg/vial
~Dose: Based on approved package insert and physician's discretion Recommended initial dose: 3 mg/kg/day
~Dosing schedule:
~All patients will receive Lipo-AB® based on the approved package insert and physician's clinical decision."
15918101|NCT03511807|Other|Electrical|"For the electrical stimulation:
~An electrode will be inserted into the ear canal which will be stimulated."
15918102|NCT03511807|Other|Acoustic|"For the acoustic stimulation:
~A typical sound will be presented for 6 minutes. Loudness is reported for 4 minutes after the stimulus offset to measure the presence and duration of the residual inhibition. If a successful acoustic stimulus is found, the subject will be given a series of sound files to listen to on a digital music player (CD or MP3 player) and will be asked to listen to each sound file (5 minute duration) and record their tinnitus loudness/annoyance during and after each sound stimulation. For some subjects, the investigators will use music on a digital music player (MP3 player) to see if music listening and music exercises will help reduce the intensity or annoyance level of the tinnitus (using the same surveys). These music-based exercises will involve training in recognition of musical intervals (e.g., octaves, fifths, and thirds)."
15918103|NCT03511781|Radiation|Hypofractionated Radiotherapy|Palliative Hypofractionated radiotherapy 35 GY in 10 fractions over 2 weeks in advanced incurable Breast Cancer
15918104|NCT03511768|Drug|18F-AlF-NOTA-octreotide|One injection of 18F-AlF-NOTA-octreotide
15918105|NCT03511768|Device|PET/CT|Following injection of 18F-AlF-NOTA-octreotide the participants will be subjected to whole body PET/CT
15918106|NCT03511755|Device|Transdermal Electrical Neuromodulator (TEN)|Thync TEN is a portable, battery-powered, electrical neuromodulation device connected to single-use gel electrode pads that are applied to the base of the neck (C3 to C7).
15918107|NCT03511716|Device|HRT Mitral Bridge Mitral Valve Repair|Surgical mitral valve implant intended to reduce mitral regurgitation by direct reduction of the septo-lateral mitral annular diameter, promoting early coaptation of the valve leaflets and restraining the leaflets below the intra-annular plane
15918108|NCT03511703|Drug|Apatinib|Apatinib, a small molecule anti-angiogenic targeted drug that has been demonstrated to be safe and effective after failure of standard chemotherapy for advanced gastric cancer, has been initially successful in phase II clinical trials for the treatment of unresectable advanced HCC patients. The efficacy of ralfiny in the treatment of Oriental population (ORIENTAL study) is better. The randomized, doubleblind, multi-center phase III clinical study of apatinib second-line treatment of advanced hepatocellular carcinoma showed a good efficacy and safety. Currently, Phase III clinical studies of apatinib in HCC patients undergoing systemic chemotherapy or sorafenib treatment have progressed. Initial results lso showed good efficacy and safety.
15918109|NCT03511703|Drug|Chemotherapy drugs+Iodized oil|Intra-arterial infusion chemotherapy for tumors, commonly used chemotherapy drugs include anthracyclines, platinum, etc.; chemotherapeutic drugs and embolic agents are mixed together and injected through the blood supply artery of the tumor. The most commonly used embolic agent for TACE treatment is a lipiodol emulsion. First infusion of some chemotherapy drugs, the general infusion time should not be <20 min. Then another part of the chemotherapeutic drugs and lipiodol were mixed into emulsions for embolization. The amount of lipiodol is generally 5-20 ml, not more than 30 ml.
15918110|NCT03511690|Behavioral|BRCA-Gist|"BRCA-gist is an innovative Intelligent Tutoring System intervention that uses avatars to emulate tailored one-to-one human tutoring and includes the bottom-line meaning of risk messages. BRCA-gist is designed to provide the same information contained in four modules from the NCI webpages: breast cancer and metastasis, risk factors, genetic mutation testing, and the consequences of testing."
15918111|NCT03511677|Device|Insole|Customized insole
15918112|NCT03511677|Device|Placebo Insole|Placebo flat insole
15918113|NCT03511664|Drug|177Lu-PSMA-617|administered intravenously once every 6 weeks (1 cycle) for a maximum of 6 cycles. After 4 cycles, patients will be assessed for (1) evidence of response, (2) residual disease, and (3) tolerance to 177Lu-PSMA-617. If all 3 assessments are met the patient may receive an additional 2 cycles of 177Lu-PSMA-617.
15918114|NCT03511664|Other|Best supportive/best standard of care|Best supportive/best standard of care as defined by the local investigator
15918115|NCT03511651|Procedure|PEEP|Two PEEP levels will be used during mechanical ventilation.
15918118|NCT03511625|Drug|Acthar Injectable Product|Acthar is a non-specific melanocortin receptor agonist
15918119|NCT03511625|Drug|Depo medrol|Depo medrol is an anti-inflammatory glucocorticoid
15918120|NCT03511612|Diagnostic Test|Measure ankle brachial index (ABI)|This is a head-to-head comparison of 2 methods of determination of the ABI, taking the Doppler method as the standard and the oscillometric device AVP as the challenger
15918121|NCT03511599|Drug|Cycloserine|Cycloserine 100mg
15918122|NCT03511599|Device|Transcranial Magnetic Stimulation|Single-pulse transcranial magnetic stimulation and theta-burst stimulation
15918123|NCT03511599|Drug|Placebo Oral Tablet|Placebo tablet matched to cycloserine tab
15918124|NCT03511573|Procedure|bariatric and other laparoscopic surgery|We have obtained liver samples during laparoscopic surgical procedures in the majority of cases. The majority of laparoscopic procedures were sleeve gastrectomies performed for morbid obesity as a primary restrictive procedure; in 5 cases the liver biopsies were performed during laparoscopic cholecystectomies.
15918125|NCT03511560|Drug|Tacrolimus Extended Release Oral Tablet|Tacrolimus, extended-release, oral (Envarsus); 0.75 mg, 1 mg, 4 mg tablets will be administered once daily at initial weight-based dose of 0.12 mg/kg.
15918126|NCT03511560|Drug|Tacrolimus|Tacrolimus immediate-release, oral; 0.5 mg, 1 mg, 5 mg capsules will be administered twice daily per clinical judgment of supervising physician
15918127|NCT03511547|Device|Pitch Patch|The patients will be operated by shoulder arthroscopy according to the internationally standardized procedure. Patients allocated this group will receive a synthetic (Pitch-Patch™ [PP]) augmentation.
15918128|NCT03511547|Device|ArthroFlex|The patients will be operated by shoulder arthroscopy according to the internationally standardized procedure. Patients allocated this group will receive a biologic patch (ArthroFlex® [AF]) augmentation.
15918129|NCT03511534|Behavioral|Psychotherapy|Evidenced based psychotherapy by a trained psychologist
15918130|NCT03511534|Other|Pharmacotherapy|Pharmacotherapy by a psychiatrist
15918134|NCT03511508|Behavioral|ChroPreg + standard care|"Ongoing update of individual maternity care plan.
~Extra consultation with the specialized midwife at 20-24 weeks of pregnancy about psychological well-being during pregnancy.
~Extra consultation with the specialized midwife at 30-33 weeks of pregnancy about individual birth preparation, breastfeeding and post-partum care.
~Possibility for psychologist consultation.
~Post-partum: Telephone follow-up by the specialized midwife 1 and 2 weeks after discharge.
~Postnatal follow-up: 4-6 weeks after delivery: conversation with specialized midwife about the pregnancy and birth."
15918135|NCT03511495|Diagnostic Test|Galilei Corneal Topographer|A series of five measurements via the Galilei corneal topographer of each keratoconic eye in quick succession
15918136|NCT03511482|Device|myAsthma Application|myAsthma Application is a Multi facetted online self management tool developed by my mhealth Ltd, which is an online interface for patient to feedback symptoms and (Quality of Life) QoL score. The app consists of an online action /self management plan, Patient education videos, medication diary, Peak Flow diary, Inhaler technique videos, mindfulness videos as well as weather and Pollution forecasters.
15918137|NCT03511482|Device|Lloyds Pharmacy Online Doctor|"Online Doctor is part of Expert Health Ltd a doctor-led initiative providing safe and reliable remote online healthcare to adults in the UK. Their patient-centred model of healthcare allows patients to tailor care around their schedule and increases healthcare access for harder-to-reach patient groups.
~As the first ever online healthcare organisation to register with the government regulator of healthcare - and having received outstanding feedback from the Care Quality Commission about the high level of safe, effective, caring, responsive and well led care provided by the service - They pride themselves on their pioneer status and work constantly to expand the boundaries of personalised healthcare."
15918138|NCT03511469|Other|Control Group|Control Group: Standart rehabilitation
15918139|NCT03511469|Other|Isokinetic Group|Concentric group: Standart rehabilitation + isokinetic training
15918140|NCT03511456|Procedure|PELD operation|"Under local anesthesia, the introduction of 20G needles could be performed with fluoroscopy. After the needle traveled through TFS space, extremely care was needed to avoid nerve root injury.
~Discography was recommended. The following steps were performed as usual: the needle was replaced by a guide wire; a 9 mm incision was made in the skin; a tapered cannulated dilator was inserted along the guide wire; and finally a working cannula was inserted.
~The remove of disc was performed carefully under endoscope. The first step was to locate the annulus fibrosis of L5/S1 disc, then by using nerve dissector and bipolar elliquence, soft tissue including fat tissue, muscle and fibers of ligaments were pushed cephalad until the blue stained herniated disc was visible and removed."
15918141|NCT03511443|Diagnostic Test|hsRDT|Testing highly sensitive RDT detection for low parasitemia
15918143|NCT03511404|Other|physiotherapy rehabilitation|All subjects will receive a course of conventional physiotherapy that incorporating components of pain relief and functional restoration with the use of electrotherapy and exercise therapy for twelve sessions twice weekly in six weeks guided by a registered physiotherapist in Hong Kong.
15918144|NCT03511391|Drug|Nivolumab or Pembrolizumab or Atezolizumab|per national standard of care
15918145|NCT03511391|Radiation|SBRT|Stereotactic body radiotherapy is administered to maximally 3 lesions in 3 fractions of 8Gy prior to the second/third cycle of checkpoint inhibitors.
15918146|NCT03511378|Drug|Lupin's Pegfilgrastim|Administration of Pegfilgrastim
15918147|NCT03511378|Drug|Neulasta®|Administration of Neulasta®
15918148|NCT03511365|Biological|Probiotic Formulation VSL#3|Probiotic VSL#3 administration.
15918149|NCT03511352|Behavioral|Frequent sit-to-stands|Participants will visit the clinic for a 6-hour monitoring period. Following a 1-hour sitting run-in period, participants will sit for an additional 5-hour period including a 2-min stand every 15 min throughout the 5-hr protocol period. Baseline, mid-point, and end-of-visit bathroom breaks for urine sample collection will be conducted, with additional bathroom breaks allowed as needed.
15918150|NCT03511352|Behavioral|Stand More|Participants will visit the clinic for a 6-hour monitoring period. Following a 1-hour sitting run-in period, participants will sit for an additional 5-hour period including 5 8-minute standing interruptions, 1 per hour. Baseline, mid-point, and end-of-visit bathroom breaks for urine sample collection will be conducted, with additional bathroom breaks allowed as needed.
15918151|NCT03511339|Device|TecTraum device|"A non-invasive hypothermic therapy (cold therapy) TecTraum device that provides localized cooling of the head and neck."
15918152|NCT03511326|Drug|Methyl Aminolaevulinate 16% Cream|Subject will received one session of methyl aminolevulinate Daylight Photodynamic therapy
15918153|NCT03511313|Device|Renal denervation|After a renal angiography according to standard procedures, subjects are treated with renal denervation (with sterile irrigated deflectable ablation catheter in renal artery), if without renal anatomic abnormality not detected by Renal CT/CTA.
15918154|NCT03511313|Diagnostic Test|Renal angiography|A renal angiography according to standard procedure.
15918155|NCT03511300|Behavioral|Goal-Setting Instructions|"In the goal-setting instruction condition, participants will be asked to increase their performance by 20% from the previous similar test (e.g., On this task, you generated 10 words when I asked you to name as many words as you could that start with the letter 'F.' Now, I want you to aim to generate at least 12 words for the letter 'F'.)"
15918156|NCT03511300|Behavioral|Standard Instructions|Participants in this group will receive the standardized instructions for completing the tests, as outlined in the test appendices.
15918157|NCT03511287|Other|Inspiratory Muscle Training|Breathing through a device that offers resistance during inspiration. In this study the POWERbreathe device was used (POWERbreathe® K3, HaB International Ltd, UK).
15918158|NCT03511274|Behavioral|Hygiene based educational film|Pregnant women will watch an educational film to increase the awareness of CMV, encourage the adoption of risk reduction behaviours and preventative strategies. The film will include women's views of the risks of CMV infection in pregnancy and how they adopted the preventative strategies.
15918159|NCT03511261|Drug|10% Curcumin mucoadhesive gel|Group 1 10%of mucoadhesive gel for topical application two times per day.
15918160|NCT03511261|Drug|Curcumin capsules 500mg|Group 2 curcumin 500 mg capsules for oral intake two times per day
15918206|NCT03511118|Other|Rosuvastatin|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15918161|NCT03511261|Drug|5% curcumin mucoadhesive gel + Curcumin capsules 250 mg|Group 3 5% curcumin mucoadhesive gel topical application two times per day + curcumin 250 mg capsules for oral intake two times per day
15918162|NCT03511261|Drug|Placebo capsule|Group 4 placebo capsules for oral intake two times per day
15918163|NCT03511248|Dietary Supplement|Nitrate-rich Beetroot Juice|The beetroot juice contains approximately 100kcal per 100mL of juice, equivalent to a glass of orange juice; the volume of juice per day for the study is 70mL. Volunteers will be informed that an average woman weighing 65kg should not consume more than 2000kcal per day, and an average man of 75kg not more than 2500kcal per day.
15918164|NCT03511248|Dietary Supplement|Nitrate-deplete Beetroot Juice|The beetroot juice contains approximately 100kcal per 100mL of juice, equivalent to a glass of orange juice; the volume of juice per day for the study is 70mL. Volunteers will be informed that an average woman weighing 65kg should not consume more than 2000kcal per day, and an average man of 75kg not more than 2500kcal per day.
15918165|NCT03511222|Drug|Vorolanib|Patients should take vorolanib at approximately the same time every day with food.
15918166|NCT03511222|Drug|Nivolumab|Standard of care
15918167|NCT03511222|Drug|Pembrolizumab|Standard of care
15918168|NCT03511209|Behavioral|CBTI plus taper method A|This intervention includes CBTI plus the novel hypnotic tapering method.
15918169|NCT03511209|Behavioral|CBTI plus taper method B|This intervention includes CBTI plus the usual hypnotic tapering method used by the VA.
15918170|NCT03511196|Drug|Adaptive Androgen Deprivation Therapy (ADT)|ADT with Leuprolide, Goserelin, or Triptorelin, as GnRH agonist, every 4 weeks as outlined in study arm description.
15918171|NCT03511196|Drug|Abiraterone|Prednisone 5 mg once a day with food.
15918172|NCT03511196|Drug|Prednisone|Abiraterone 1000 mg daily with empty stomach.
15918173|NCT03511183|Drug|XELIRI + bevacizumab|Irinotecan，200mg/㎡,d1;Capecitabine, 1000mg/㎡ bid1-14;Bevacizumab,7.5mg/kg ,d1; every 21 days as a cycle
15918174|NCT03511183|Drug|XELOX + bevacizumab|Oxaliplatin ,130mg/㎡,d1;Capecitabine, 1000mg/㎡ bid1-14;Bevacizumab,7.5mg/kg ,d1; every 21 days as a cycle
15918175|NCT03511170|Drug|XELIRI|Irinotecan，200mg/㎡,d1;Capecitabine, 850-1250mg/㎡ bid 1-14;every 21 days as a cycle
15918176|NCT03511170|Drug|XELOX|Oxaliplatin ,130mg/㎡,d1;Capecitabine, 1000mg/㎡ bid 1-14;every 21 days as a cycle
15918179|NCT03511144|Device|Unity Knee™ TKR using measured resection|Total knee replacement using the Unity Knee™ implanted with the measured resection surgical technique
15918180|NCT03511144|Device|Unity Knee™ TKR using ligament balancing|Total knee replacement using the Unity Knee™ implanted with the ligament balancing surgical technique
15918185|NCT03511118|Other|Tranexamic acid (TXA)|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15918186|NCT03511118|Other|labetalol|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15918187|NCT03511118|Other|metformin|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15918188|NCT03511118|Other|nifedipine|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15918189|NCT03511118|Other|clindamycin|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15918190|NCT03511118|Other|oxycodone|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15918191|NCT03511118|Other|azithromycin|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15918192|NCT03511118|Other|escitalopram|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15918193|NCT03511118|Other|sertraline|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15918194|NCT03511118|Other|ondansetron|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15918195|NCT03511118|Other|Ciprofloxacin|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15918196|NCT03511118|Other|Doxycycline|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15918197|NCT03511118|Other|Levofloxacin|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15918198|NCT03511118|Other|Methylphenidate|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15918199|NCT03511118|Other|Sumatriptan|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15918200|NCT03511118|Other|Citalopram|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15918201|NCT03511118|Other|Cyclobenzaprine|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15918202|NCT03511118|Other|Furosemide|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15918203|NCT03511118|Other|Gabapentin|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15918204|NCT03511118|Other|Hydrochlorothiazide|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15918208|NCT03511118|Other|Trazodone|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15918209|NCT03511118|Other|Valganciclovir|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15918210|NCT03511118|Other|Venlafaxine|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15918211|NCT03511118|Other|Verapamil|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15918212|NCT03511118|Other|Remdesivir|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15918213|NCT03511118|Other|Anakinra|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15918214|NCT03511118|Other|Tocilizumab|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15918215|NCT03511118|Other|Fluvoxamine|Understudied drugs will be administered in accordance with local SOC as prescribed by the lactating woman's healthcare provider.
15918216|NCT03511105|Drug|GSK2798745|GSK2798745 will be available as white to slightly colored, round biconvex tablets to be administered via the oral route.
15918217|NCT03511105|Drug|Placebo|Placebo matching to GSK2798745 will be available as white to slightly colored, round biconvex tablet to be administered via the oral route.
15918218|NCT03511105|Drug|Lipoplysaccharide from Escherichia Coli|LPS will be used as challenge agent. About 4 nanogram per kilogram of LPS will be instilled into the right middle lung segment via bronchoscopy 2 hours after dosing with GSK2798745 or placebo on Day 1.
15918219|NCT03511105|Drug|Saline|Sterile saline (0.9%) will be used as control challenge. Saline will be instilled into the lingula segment of contralateral side of lung via bronchoscopy 2 hours after dosing with GSK2798745 or placebo on Day 1.
15918220|NCT03511092|Dietary Supplement|HMB-FA|One gram of HMB-FA was ingested before exercise, and two grams were ingested at subsequent meals (1 g per meal). At rest days supplement was administered 1 g per meal. The total duration of the intervention was 8 weeks.
15918221|NCT03511092|Dietary Supplement|HMB-Ca|One gram of HMB-Ca was ingested before exercise, and two grams were ingested at subsequent meals (1 g per meal). At rest days supplement was administered 1 g per meal. The total duration of the intervention was 8 weeks.
15918222|NCT03511092|Dietary Supplement|alfa-HICA|Five hundred miligram of alfa-HICA was ingested before exercise, and one gram was ingested at subsequent meals (500 mg per meal). At rest days supplement was administered 500 mg per meal. The total duration of the intervention was 8 weeks.
15918223|NCT03511092|Other|Placebo comparator|One gram of magnesium stearate was ingested before exercise, and two grams were ingested at subsequent meals (1 g per meal). At rest days placebo was administered 1 g per meal. The total duration of the intervention was 8 weeks.
15918224|NCT03511079|Behavioral|Music|Music will be delivered through Pandora Plus radio via patient's computer or smartphone. The patient will choose a favorite song to create a playlist which will be used for the duration of the entire study. The subgenre of the initial song will be recorded.
15918225|NCT03511066|Drug|CT-P27 Dose1|Influenza A treatment drug.
15918226|NCT03511066|Drug|CT-P27 Dose2|Influenza A treatment drug.
15918227|NCT03511066|Drug|Placebo|Placebo.
15918228|NCT03511053|Procedure|Epidural Steroid Injection with Lavage|All participants will receive a saline lavage prior to the epidural steroid injection.
15918229|NCT03511040|Device|Lumenate Intraluminal Device|Dilation of vasospastic intracranial vessels
15918230|NCT03511027|Device|SME + Karie Device|For the duration of the study, participants will use the Karie device to promote medication adherence. The Karie device prompts users to take their medication in the right amount at the right time.
15918231|NCT03511027|Other|SME only|At discharge, participants will be provided with self-medication education.
15918232|NCT03511014|Device|Microcurrent|Micrucurrent will be apply
15918233|NCT03511001|Other|E-Cigarette Vs. Smoking as Usual|6 weeks of JUUL e-cigarettes vs. 6 weeks of smoking as usual
15918235|NCT03510975|Drug|desmopressin melt form 120 μg|desmopressin melt form 120 μg (Minirin, Ferring International center, Switzerland) once daily before going to bed
15918236|NCT03510975|Behavioral|Verbal behavioral therapy|Verbal behavioral therapy includes reward system, restriction excessive fluid intake, lifting and waking after sleep to urinate, keeping daily voiding diary
15918237|NCT03510975|Behavioral|Behavioral therapy with written check-list|Behavioral therapy with written check-list includes reward system, restriction excessive fluid intake, lifting and waking after sleep to urinate, keeping daily voiding diary, ensuring optimal posture to facilitate good bladder function and bowel movements, avoding holding urine, encouring healthy diet
15918238|NCT03510962|Other|Group 1: no intervention|Unstimulated saliva samples are collected from the subject to measure the pH of saliva after 5, 15, 30, 45 and 60 minutes of consumption of the test mixed fruit juice without any intervention.
15918239|NCT03510962|Other|Group 2: tap water gargle|The subject will use 10 ml of tap water as mouth rinse to swish for 60 seconds and spit. Unstimulated saliva samples are collected from the subject to measure and record the pH of saliva at 15, 30 and 45 minutes after the subject completes the gargle as an intervention.
15918240|NCT03510962|Drug|Group 3: 0.2% Chlorhexidine|The subject will use 10 ml of 0.2% Chlorhexidine mouth rinse (Rexidine®, Indoco Remidies Ltd, Mumbai, India) to swish for 60 seconds and spit. Unstimulated saliva samples are collected from the subject to measure and record the pH of saliva at 15, 30 and 45 minutes after the subject completes the gargle as an intervention.
15918241|NCT03510962|Other|Group 4: Fluoridated tooth paste|"The subject will Brush with fluoridated toothpaste-(Colgate Total®, Colgate-Palmolive Company, Mumbai, India) for 2 minutes using soft brush.
~Unstimulated saliva samples are collected from the subject to measure and record the pH of saliva at 15, 30 and 45 minutes after the subject completes using tooth paste as an intervention."
15918242|NCT03510962|Other|Group 5: Polyol containing gum|"The subject will chew polyol containing gum (Orbit®, WrigleyCompany) for 5 minutes and spit.
~Unstimulated saliva samples are collected from the subject to measure and record the pH of saliva at 15, 30 and 45 minutes after the subject completes chewing as an intervention."
15918243|NCT03510962|Other|Group 6: 1% sodium bicarbonate solution|"The subject will use 10 ml freshly prepared 1% sodium bicarbonate w/v solution to swish for 60 seconds and spit.
~Unstimulated saliva samples are collected from the subject to measure and record the pH of saliva at 15, 30 and 45 minutes after the subject completes the gargle as an intervention."
15918244|NCT03510949|Device|Nasopharyngeal airway or laryngeal mask airway|Comparing the incidence of postoperative soar throat with the use of nasopharyngeal airway versus laryngeal mask airway
15918245|NCT03510936|Dietary Supplement|Probiotics|the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis with does of 1.5*10^7CFU for 2 weeks
15918246|NCT03510923|Other|Inspection and palpation of the appendix|The removed appendix will be evaluated for tumours by the operating surgeon by visual inspection and digital palpation of the specimen. The appendix will not be opened. The surgeon will report his or her findings on a predefined scoring form: he or she will report all abnormalities and writes down whether he or she considers there is an indication for histopathological examination. Subsequently, all specimens will be sent for histopathological examination. Histopathological examination will be conducted according to the local protocol. In case of a neoplasm of the appendix, the treatment strategy is discussed and decided by the local multidisciplinary team. If an additional more extensive resection is decided to be appropriate, the specimens of the re-resection will be evaluated for the presence of remaining tumour tissue.
15918247|NCT03510923|Other|Inspection and palpation of the gallbladder|The removed gallbladder will be evaluated for tumours by the operating surgeon by visual inspection and digital palpation of the specimen. The gallbladder is opened in its length, without cutting the cystic duct, and is inspected and palpated. The surgeon will report his or her findings on a predefined scoring form: he or she will report all abnormalities and writes down whether he or she considers there is an indication for histopathological examination. Subsequently, all specimens will be sent for histopathological examination. Histopathological examination will be conducted according to the local protocol. In case of a neoplasm of the gallbladder, the treatment strategy is discussed and decided by the local multidisciplinary team. If an additional more extensive resection is decided to be appropriate, the specimens of the re-resection will be evaluated for the presence of remaining tumour tissue.
15918248|NCT03510910|Drug|Acetaminophen|acetaminophen 600 mg to be taken every 8 hours (TID)
15918249|NCT03510910|Drug|Percocet|"Oxycodone/acetaminophen (Percocet) 5 mg/325 mg as needed for breakthrough pain for patients in Percocet+ Acetaminophen group.
~Percocet Group will receive standard of care Percocet 5 mg/325 mg every 6 hours PRN"
15918250|NCT03510897|Drug|teprasiran|IV injection
15918251|NCT03510897|Drug|Placebo|isotonic saline
15918252|NCT03510884|Drug|Alirocumab SAR236553 (REGN727)|Pharmaceutical form:solution Route of administration: subcutaneous injection
15918253|NCT03510884|Drug|Rosuvastatin|Pharmaceutical form:tablet Route of administration: oral
15918254|NCT03510884|Drug|Atorvastatin|Pharmaceutical form:Tablet Route of administration: Oral
15918255|NCT03510884|Drug|Simvastatin|Pharmaceutical form:Tablet Route of administration: Oral
15918256|NCT03510884|Drug|Pravastatin|Pharmaceutical form:Tablet Route of administration: Oral
15918257|NCT03510884|Drug|Lovastatin|Pharmaceutical form:Tablet Route of administration: Oral
15918258|NCT03510884|Drug|Fluvastatin|Pharmaceutical form:Capsule Route of administration: Oral
15918259|NCT03510884|Drug|Ezetimibe|Pharmaceutical form:Tablet Route of administration: Oral
15918260|NCT03510884|Drug|Cholestyramine|Pharmaceutical form:oral suspension Route of administration: oral
15918261|NCT03510884|Drug|Nicotinic acid|Pharmaceutical form:Tablet Route of administration: Oral
15918262|NCT03510884|Drug|Fenofibrate|Pharmaceutical form:Tablet Route of administration: Oral
15918263|NCT03510884|Drug|Omega-3 fatty acids|Pharmaceutical form:capsule Route of administration: oral
15918264|NCT03510884|Drug|Placebo|Pharmaceutical form:solution Route of administration: subcutaneous injection
15918265|NCT03510871|Drug|nivolumab, ipilimumab|All enrolled subjects will receive nivolumab 3 mg/kg plus ipilimumab 1 mg/kg intravenously on day 1 of each cycle (every 3 weeks). Tumor assessment will be done after 6 weeks (2 cycles) and 12 weeks (4 cycles).
15918266|NCT03510858|Other|Multilevel training intervention (intervention group)|QC meetings with PCPs in the intervention group to reflect on their CRC screening practices and implement changes in sequential Plan-Do-Check-Act (PDCA) quality improvement cycles. In the first meeting, they will be given evidence summaries on CRC screening, a decision support leaflet designed to help them discuss CRC screening with their patients and a patient decision aid in form of a brochure (Plan-Do). PCPs will receive sample FIT kits recommended for organized screening programs and will be encouraged to offer FIT tests if they have not done so before. In the second QC meeting, PCPs will be shown how to fill out the patient data collection form (Check). The third QC meeting will take place after data collection and analysis. Researchers will present their results to the QCs and PCPs will discuss subsequent steps to improve care (Act). The QC will then repeat one PDCA cycle. The control group will receive the same intervention one year later.
15918267|NCT03510858|Other|Multilevel training intervention (control group with crossover)|The control group will undergo a crossover and receive the same intervention one year after the intervention group. QC meetings with PCPs in the intervention group to reflect on their CRC screening practices and implement changes in sequential Plan-Do-Check-Act (PDCA) quality improvement cycles. In the first meeting, they will be given evidence summaries on CRC screening, a decision support leaflet designed to help them discuss CRC screening with their patients and a patient decision aid in form of a brochure (Plan-Do). PCPs will receive sample FIT kits recommended for organized screening programs and will be encouraged to offer FIT tests if they have not done so before. In the second QC meeting, PCPs will be shown how to fill out the patient data collection form (Check). The third QC meeting will take place after data collection and analysis. Researchers will present their results to the QCs and PCPs will discuss subsequent steps to improve care (Act).
15918268|NCT03510845|Procedure|Arthroscopic ACL Primary Repair|"All patients (in both groups) will undergo diagnostic knee arthroscopy at the start of the procedure; those in the experimental arm repairable ACL tear, whose ACL found to be avulsed from its femoral insertion or has a proximal tear, and intra-operatively, found to have a good tissue quality, will undergo arthroscopic ACL primary repair using fiberwires and SwiveLock screw to anchor the ligament into its origin, in the femoral condyle."
15918505|NCT03509012|Radiation|External beam radiation (dose level 2)|radiation therapy
15918269|NCT03510845|Procedure|Arthroscopic ACL Reconstruction|Patients whose ACL cannot be repaired, will undergo arthroscopic ACL reconstruction using hamstring tendons.
15918270|NCT03510806|Dietary Supplement|Supplement|dietary supplement contain protein from milk and fruit extract
15918271|NCT03510806|Other|Placebo|color, taste, and calorie-matched placebo
15918272|NCT03510793|Drug|balanced anesthesia|patients undergoing open elective abdominal aortic aneurysm repair will receive balanced (desflurane + remifentanil) anaesthesia
15918273|NCT03510793|Drug|Total intravenous anesthesia|patients undergoing open elective abdominal aortic aneurysm repair will receive total intravenous (propofol + remifentanil with target-controlled infusion) anesthesia
15918274|NCT03510780|Procedure|Periodontal surgery with Enamel Matrix Derivative|Patients will be treated by periodontal surgical flaps with the addition of EMD + bone graft
15918275|NCT03510780|Procedure|Periodontal surgery with Platlet Rich fibrin|Patients will be treated by periodontal surgical flaps with the addition of PRF + bone graft
15918276|NCT03510767|Drug|TQ-B3525|TQ-B3525 p.o. qd
15918277|NCT03510754|Procedure|Eus guided biliary drainage|"After reaching the cardia or the lesser curvature of the stomach, for the transgastric approach, or the duodenal bulb, for the transduodenal one, intrahepatic left and extrahepatic bile ducts were punctured with a 19-gouge needle and the access was confirmed the injection of contrast under fluoroscopy to obtain an anterograde cholangiogram.
~A 0.035-inch guide was advanced into the selected bile duct and under EUS and fluoroscopic view a stent was placed through the hepatogastrostomy between a left bile duct and the gastric lumen or through the choledochoduodenostomy between the common bile duct and the duodenal lumen."
15918278|NCT03510741|Drug|Sodium Benzoate|Sodium Benzoate will be administered at 1000mg daily
15918279|NCT03510741|Drug|N-Acetylcysteine|N-Acetylcysteine 1000 mgs twice daily dose
15918280|NCT03510741|Drug|Placebo|Placebo added to TAU
15918281|NCT03510741|Drug|Sodium Benzoate Plus N-Acetylcysteine|Sodium Benzoate will be administered at 1000mg daily and NAC 1000 mgs twice daily dose
15918282|NCT03510728|Behavioral|college drinker's check up|The College Drinker's Check-up (CDCU) is a single session, computer-based brief motivational intervention for heavy drinking college students. It takes a student about 45 minutes to go through it.
15918283|NCT03510728|Behavioral|Protective Behavioral Strategies Intervention|This intervention component focuses on educating and promoting PBS activities in future college drinking situations
15918284|NCT03510728|Behavioral|Ecological Momentary Intervention|This EMI is delivered during drinking situations and focuses on promoting PBS use during that particular drinking situation.
15918285|NCT03510715|Drug|Alirocumab SAR236553 (REGN727)|"Pharmaceutical form: solution for injection in pre-filled syringe,
~Route of administration: subcutaneous (SC)"
15918286|NCT03510715|Drug|Atorvastatin|"Pharmaceutical form: tablet,
~Route of administration: oral"
15918287|NCT03510715|Drug|Simvastatin|"Pharmaceutical form: tablet,
~Route of administration: oral"
15918288|NCT03510715|Drug|Fluvastatin|"Pharmaceutical form: capsule,
~Route of administration: oral"
15918289|NCT03510715|Drug|Pravastatin|"Pharmaceutical form: tablet,
~Route of administration: oral"
15918290|NCT03510715|Drug|Lovastatin|"Pharmaceutical form: tablet,
~Route of administration: oral"
15918291|NCT03510715|Drug|Rosuvastatin|"Pharmaceutical form: tablet,
~Route of administration: oral"
15918292|NCT03510715|Drug|Ezetimibe|"Pharmaceutical form: tablet,
~Route of administration: oral"
15918293|NCT03510715|Drug|Cholestyramine|"Pharmaceutical form: oral suspension,
~Route of administration: oral"
15918294|NCT03510715|Drug|Nicotinic acid|"Pharmaceutical form: tablet,
~Route of administration: oral"
15918295|NCT03510715|Drug|Fenofibrate|"Pharmaceutical form: tablet,
~Route of administration: oral"
15918296|NCT03510715|Drug|Omega-3 fatty acids|"Pharmaceutical form: capsule,
~Route of administration: oral"
15918297|NCT03510702|Diagnostic Test|Levels of epigenetic biomarkers present in the gingival fluid and its possible relationship with bone metabolism.|"Once the anamnesis has been done, all the records corresponding to the Gingival Index and Plaque Index, in both groups are taken.
~Subsequently, samples of gingival crevicular fluid are taken for the screening of epigenetic biomarkers."
15918298|NCT03510689|Diagnostic Test|echocardiography|Resting echocardiograms (Vivid E9 or E95, GE Healthcare) with conventional measures of systolic and diastolic function, in conjunction with posthoc quantitation of novel measures of strain and strain rate will be obtained at each study time point.
15918299|NCT03510689|Other|Cardiopulmonary Exercise Testing|A cardiopulmonary exercise test (CPET, also called V02 test) will be completed at each study time point utilizing a standard clinical protocol, on either a stationary bike or treadmill. The purpose of this test is to estimate maximal oxygen consumption (V02 max) as in index of cardiopulmonary fitness. Resting ECG, heart rate, and BP will be obtained prior to beginning the test, during each stage of the test and for 5 minutes after the test is stopped.
15918300|NCT03510689|Other|Blood Collection|We will obtain blood samples (approximately 16mL) at baseline and (approximately 12mL) at each follow-up visit. Typically these will be drawn via peripheral venipuncture, however if patients have a port-a-cath in place, blood may be drawn from the port instead.
15918301|NCT03510676|Device|NiTiDES|
15918302|NCT03510663|Drug|OPC-61815 16mg|OPC-61815 16mg will be intravenously administered once a week.
15918303|NCT03510663|Drug|OPC-61815 32mg|OPC-61815 32mg will be intravenously administered once a week.
15918304|NCT03510663|Drug|Moxifloxacin|400mg tablet will be administrated once a week.
15918305|NCT03510663|Drug|Placebos|Placebo will be intravenously administered once a week.
15918306|NCT03510624|Drug|Rebaudioside A|Rebaudioside A 3g
15918307|NCT03510624|Drug|Placebo|Empty capsules
15918308|NCT03510611|Drug|Ensartinib with fed or fasting|The two groups of subjects were given an equal dose of Ensartinib capsules (225 mg) after a single cross-over fasting or high-fat high-calorie diet in two different test cycles to examine the effect of food on the pharmacokinetics of Ensartinib.
15918309|NCT03510598|Device|The ZELTIQ System|The CoolSculpting machine will be used to perform the treatments.
15918310|NCT03510598|Drug|Kybella 20 MG in 2 ML Injection|Injectable drug called KYBELLA® (deoxycholic acid)
15918311|NCT03510585|Other|saline and sniffing|This technique is a combination of positioning (laying down), saline instilation (5 ml in each side), sniffing (the side that received saline instilation) and throat vibration. Then the other side.
15918312|NCT03510585|Other|sniffing|This technique is a combination of positioning (laying down), sniffing (the side that received saline instilation) and throat vibration. Then the other side.
15918313|NCT03510572|Drug|[18F]PI-2620|Imaging for evaluating the accumulation of abnormal tau protein in the brain
15918314|NCT03510559|Drug|Forearm Nerve Block|Blockade of the arm below the elbow using local anesthetic (0.5% bupivacaine and 2% lidocaine) deposited under ultrasound guidance to facilitate performance of the surgical procedure.
15918315|NCT03510559|Drug|Brachial Plexus Block|Blockade of the entire arm using local anesthetic (0.5% bupivacaine and 2% lidocaine) deposited under ultrasound guidance to facilitate performance of the surgical procedure.
15918316|NCT03510546|Drug|Pyridostigmine|Study dose as per protocol.
15918317|NCT03510546|Drug|Placebo oral capsule|Study dose as per protocol.
15918318|NCT03510533|Other|Evaluation of the rates of the autoantibodies directed against the neuropeptides (ghrelin and alpha-MSH) controlling involved in food intake regulation|blood samples (12ml) and stool samples (30g) collections
15918319|NCT03510520|Device|Medium Cut-Off Haemodialysis|Treatment with medium cut-off haemodialysis using the Theranova dialysis membrane 3 times per week for 6 months
15918320|NCT03510520|Device|On-Line Haemodiafiltration|Treatment with on-line haemodiafiltration (HDF) 3 times per week for 6 months (Conventional treatment)
15918321|NCT03510494|Behavioral|Augmented physical education program|Augmented physical education program
15918322|NCT03510481|Biological|PfSPZ Vaccine|PfSPZ Vaccine is Radiation attenuated, aseptic, purified, vialed, cryopreserved, NF54 P. falciparum sporozoites produced by Sanaria, Inc.
15918323|NCT03510481|Drug|Normal Saline|Clear liquid indistinguishable from the study product will be used as a placebo rather than a comparator vaccine.
15918324|NCT03510481|Drug|artemether 20mg/lumefantrine 120mg (AL)|Licensed antimalarial in the US and Mali for use for uncomplicated malaria.
15918325|NCT03510468|Drug|Vemlidy (tenofivir alafenamide)|Each tablet of Vemlidy contains 25 mg of tenofivir alafenamide.
15918326|NCT03510468|Drug|Priftin (rifapentine)|Each tablet of Priftin contains 150 mg of rifapentine. Participants who weigh 45 to < 50 kg will take 750 mg (5 tablets), and participants who weigh (Bullet) 50 kg will take 900 mg (6 tablets).
15918327|NCT03510468|Drug|Isoniazid|Each tablet of generic INH is formulated as 100 or 300 mg of the drug.
15918328|NCT03510468|Dietary Supplement|Pyridoxine|Each tablet of pyridoxine contains 50 mg of Vitamin B6.
15918329|NCT03510455|Drug|BGJ398|BGJ398, a pan-fibroblast growth factor receptor (FGFR) kinase inhibitor will be orally administered over six 4-week cycles (4 weeks on drug continuously). After the initial dose, escalation/de- escalation of BGJ398 will be based on FGF- 23 blood levels and adjusted according to protocol procedures. The six cycles of BGJ398 will be followed by 3 months off the drug and an optional extension phase.
15918330|NCT03510429|Dietary Supplement|Postoperative Nutritional Supplement|Postoperative Nutritional Supplement (newly developed ketogenic drink: NDKD)
15918331|NCT03510429|Other|Routine post-op care|Routine post-operative care
15918332|NCT03510416|Drug|Apatinib|apatinib is a kind of Inhibitor of VEGFR-2
15918333|NCT03510416|Radiation|TACE|Epirubicin,ultra-fluid lipiodol and gelatin sponge articles are used in TACE.
15918334|NCT03510403|Device|nastent™|Snorer and OSA patients (mild or moderate OSA) use the nasal airway stent for sleeping, each night for 1 month.
15918335|NCT03510390|Drug|Metformin|850 mg, oral, twice daily, 9-14 days
15918336|NCT03510377|Other|Aquatic physical intervention|For structured aquatic physical intervention group, the Ai-Chi method was selected. Ai-Chi is a simple aquatic exercise and relaxation method that uses a combination of deep breathing and slow movements of the arms, legs and torso in continual flowing patterns. The Ai-Chi intervention will occur in an hydrotherapy pool (34C).
15918337|NCT03510377|Other|On-land physical intervention|For controlled comparison of the structured physical intervention group the Tai-Chi method was selected (the same movements as the Ai-Chi). The Tai-Chi intervention will occur in a room.
15918338|NCT03510377|Other|Non physical intervention|The people who will be part of the non physical intervention will practice guided imagery of the Ai-Chi method. The guided imagery intervention will occur in a room.
15918339|NCT03510364|Behavioral|Dietary intervention|For the feeding intervention, participants consumed a meal that contains 60% of their energy daily energy requirement as a lunch time meal for 14 consecutive days under observation except during the weekends. To ensure the participant receives 60% of the daily energy requirement as a lunch meal we added a supplemental shake to the standard 1200 kcal meal.
15918340|NCT03510351|Drug|Ceftolozane-Tazobactam|Subjects treated with ceftolozane-tazobactam for Pseudomonas infections
15918341|NCT03510338|Drug|Sublingual sildenafil|100 mg biphasic sildenafil tablet
15918342|NCT03510338|Drug|Oral sildenafil|50 mg oral sildenafil (Viagra)
15918343|NCT03510325|Drug|Olanzapine|Commonly used oral antipsychotics intervention therapy.
15918344|NCT03510325|Drug|Risperidone|Commonly used oral antipsychotics intervention therapy.
15918345|NCT03510325|Drug|Aripiprazole|Commonly used oral antipsychotics intervention therapy.
15918346|NCT03510325|Drug|Amisulpride|Commonly used oral antipsychotics intervention therapy.
15918347|NCT03510325|Drug|Paliperidone long-acting injection|long-acting injection
15918348|NCT03510299|Device|Mcgrath|McGrath assisted insertion of LMA flexible
15918349|NCT03510299|Device|Control|Digital manipulation technique of LMA flexible insertion
15918350|NCT03510286|Diagnostic Test|Test-it™ PrCr Urinalysis Strips|The LifeAssay Diagnostics prototype PrCr dipstick has been designed to provide the measurement of both protein and creatinine while retaining a very low estimated cost that is comparable to the current protein-only dipsticks at $0.06-0.10 per test. In 2015, an initial laboratory-based validation study of the prototype LAD PrCr test was used on more than 500 characterized urine samples from pregnant women. This validation study demonstrated comparable accuracy for detection of severe proteinuria of the LAD PrCr test to the much more expensive commercial POC test available for PrCr determination, the Siemens Multistix® PRO 10LS. These results were compared to laboratory-based reference standard assays for proteinuria measurement.
15918351|NCT03510273|Device|Liger Medical Thermocoagulator|"Thermocoagulation treatment by Liger Medical device (US FDA 510K clearance received)"
15918435|NCT03509545|Drug|CHF Patients: ER Torsemide 40 mg|ER Torsemide 40mg given once daily to CHF patients
15918352|NCT03510260|Other|Study Group I|Study group I (e-confirmed consent only) will receive an electronic invitation to complete the consent process electronically.The COMRADE questionnaire (our primary outcome) will be obtained prior to the initiation of the traditional consent (as in control group).
15918353|NCT03510260|Other|Study Group II|The study group II will undergo the same intervention as group II but the COMRADE survey questionnaire will be obtained after the paper consent
15918354|NCT03510260|Other|Control Group|Subject will go through the consenting process at the day of surgery at the preop visit as standard in our institution only.
15918355|NCT03510221|Dietary Supplement|Antioxidants capsules|1 capsule of cranberry, 1 capsule of blueberry, and 1 capsule of pomegranate extracts were offered during 4 weeks
15918356|NCT03510208|Procedure|Near-Infrared Fluorescence Imaging|Undergo NIR imaging
15918357|NCT03510208|Biological|Panitumumab|Given IV
15918358|NCT03510208|Drug|Panitumumab-IRDye800|Given IV
15918359|NCT03510208|Device|POINPOINT-IR9000|"Intraoperative camera capable of exciting and detecting near infrared (NIR) dyes. Imaging will be performed on subjects during surgery and/or on ex-vivo resected tissues in the surgery suite (back table)."
15918360|NCT03510195|Other|MEDICORP HO PREPARATORY MODULE|3 DAY course module to prepare medical graduates to become house officers
15918361|NCT03510182|Device|transcranial direct current stimulation|
15918362|NCT03510169|Device|NeoVest|Negative pressure ventilation with NeoVest
15918363|NCT03510156|Behavioral|Behavior analytic treatment|Function-based treatment
15918364|NCT03510143|Device|Neoveil (Polyglycolic Acid Mesh)|Apply the Neoveil (Polyglycolic Acid Mesh) in the neck node dissection area in thyroid cancer surgery.
15918365|NCT03510130|Other|Routine leg movement|Routine leg movement to the right and left in the supine position during the second stage of labor, for 3 minutes every 20-30 minutes by the attending physician or nurse.
15918366|NCT03510117|Behavioral|Mindfulness|Mindfulness
15918367|NCT03510104|Drug|MRX-2843|MRX-2843 capsules
15918368|NCT03510091|Behavioral|Counseling|A video will be shown to parents of patients ages 9-18 that review HPV transmission, relation to cancer, role of immunization, myths, side effects, series timing and need for completion. All parents or legal guardians of patients will be given the option to proceed with HPV vaccination, decline, or discuss further with their provider
15918369|NCT03510078|Drug|Insulin|Insulin for glycemic control according to the allocation
15918370|NCT03510065|Device|Prevision®|One time Evaluation with documentation of one follow-up visit
15918371|NCT03510052|Behavioral|Diet Modification Pilot Program (DPM)|Investigator will administer DMP which will include a review of the booklets and any targeted recommendations based on the participant's food and symptom diary. The participant will follow the DMP for 6 weeks and report for a follow-up visit.
15918372|NCT03510039|Behavioral|Early device / Follow up|"Early device:
~Standardized Nursing Interview (30 minutes) with the Third Party Person Measure and follow the anxiety of the Third Party by rating the AMDP-AT scale, on D0 and D7
~Telephone follow-up by nurses:
~Interviews built and standardized, to M2, M4 and M6 Quantification of the AMDP-AT anxiety scale on each call"
15918373|NCT03510039|Other|Usual care|"Group Before : usual care by nurses"
15918374|NCT03510026|Device|Low thermal device preparation|One participant acts simultaneously as a control and active comparator. One internal thoracic artery is prepared with the normal electrocautery device. The other internal thoracic artery is prepared with the new low thermal device. The participant does not know, which internal thoracic artery is defined to be prepared with the low thermal device.
15918375|NCT03510013|Procedure|1-1-8 wash-in|wash-in phase during start of low flow anesthesia
15918376|NCT03510013|Drug|Sevoflurane|Drug used for wash-in protocol
15918377|NCT03510000|Drug|Empagliflozin 25mg|Individuals will test insulin dosing during different meal strategies (carbohydrate counting, plain meal announcement, no meal announcement) in a setting of the single hormone artificial pancreas with or without SGLT2 inhibitor (empagliflozin) addition. After starting the empagliflozin therapy, there will be 1-2 weeks long therapy optimization period and afterwards meal strategies will be administered. Randomization will be used to determine whether participant will start meal strategies on empagliflozin or without empagliflozin, cross-over design enables all participants to undergo all combination of approaches.
15918378|NCT03510000|Device|Single hormone artificial pancreas|Single hormone artificial pancreas will be used as a baseline background intervention standardizing the delivery and dosing of insulin. Artificial pancreas (insulin pump, continuous glucose monitoring device and dosing-suggestion algorithm) will be used by all participants on days when meal strategy intervention will be performed.
15918379|NCT03510000|Behavioral|Meal strategies|Participants will use different approaches (strategies) to insulin dose estimation for ingested carbohydrates on study days. Goal of these various strategies is to recognize magnitude of empagliflozin effect in situations when artificial pancreas algorithm is working with information of different accuracy. Individual meal approach strategies include carbohydrate counting, meal size announcement and no meal announcement. The exception will be combination of no empagliflozin and no meal announcement, which didn't result in sufficient glucose control in previous trials therefore will not be repeated in a current trial. Meal approach strategies will occur on separate days- 5 days in total each day using one meal strategy for all meals during the day.
15918380|NCT03509987|Device|HemaCue|comparing hemoglobin (Hb) levels determined by point of care testing HemaCue and arterial blood gas analyzer with an automated hematology analyzer in critically ill geriatric patients.
15918382|NCT03509961|Diagnostic Test|NGS-MRD|Next generation sequencing minimal residual disease (NGS-MRD) is a test that has increased sensitivity over multichannel flow cytometry to better identify risk of key outcomes after HCT. Patients that have a pre-HCT negative NGS-MRD results may be eligible to proceed to the treatment arm of the study that uses a non-TBI conditioning regimen.
15918383|NCT03509961|Drug|Myeloablative allogeneic HCT with a non-TBI conditioning regimen|"Myeloablative study regimen will consist of busulfan, fludarabine and thiotepa.
~day -7: Fludarabine and Busulfan day -6: Fludarabine and Busulfan day -5: Fludarabine and Busulfan day -4: Fludarabine and Busulfan day -3: Fludarabine day -2: Thiotepa day -1: Rest Day 0: Transplant"
15918384|NCT03509948|Drug|cytisine|cytisine 1.5 mg film-coated tablets
15918506|NCT03509012|Radiation|External beam radiation (hyperfractionated)|radiation therapy
15918385|NCT03509935|Other|Intervention Ultrasound Group|"Protocol:
~US 4 pulmonary quadrants in each hemithorax: anterior and lateral, upper and lower regions (figure 1)
~US inferior vena cava, collaborative index or distensibility according to the patient's conditions, in spontaneous or controlled ventilation, respectively.
~Cardiac US: subjective evaluation of contractility in normal, discreetly reduced or severely reduced."
15918386|NCT03509922|Drug|Anplag Tab. 100mg bid|sarpogrelate hydrochloride 100mg bid for 24 weeks
15918387|NCT03509922|Drug|Anplag Tab. 100mg tid|sarpogrelate hydrochloride 100mg tid for 24 weeks
15918388|NCT03509909|Behavioral|Hatha yoga|Manualized hatha yoga
15918389|NCT03509909|Behavioral|Supportive physical activity|Manualized stretching and strengthening
15918390|NCT03509896|Other|Non-Interventional|Non-Interventional
15918391|NCT03509883|Drug|Drug: Apixaban sprinkle capsules|Single dose (25 x 0.1 mg capsules), oral administration
15918392|NCT03509883|Drug|Experimental: Apixaban tablets followed by apixaban sprinkle capsules|Apixaban sprinkle capsules Single dose (25 x 0.1 mg capsules), oral administration
15918393|NCT03509870|Biological|mesenchymal stromal cells|mesenchymal stromal cells in a collagen scaffold
15918394|NCT03509857|Device|BUZZY(tm)|"Risks associated with the BUZZY(tm) device The intervention group will receive vibration only, with application of the BUZZY device just proximal to the intravenous infusion site immediately before and during propofol infusion.
~There are no known risks for the use of the BUZZY(tm) device, which is registered as an FDA class III device (therapeutic massager)."
15918395|NCT03509857|Other|No Intervention|No intervention
15918396|NCT03509844|Behavioral|Psychotherapy|Three established psychotherapeutic models for treatment of complex posttraumatic stress disorders are compared in a residential care setting. Combination of group and individual sessions.
15918397|NCT03509831|Drug|INT-2150|"Period: INT-2150
~Period: Irsogladine maleate 2 mg+Nizatidine 150 mg"
15918398|NCT03509831|Drug|Irsogladine maleate 2 mg+Nizatidine 150 mg|"Period: Irsogladine maleate 2 mg+Nizatidine 150 mg
~Period: INT-2150"
15918399|NCT03509818|Other|plyometric exercise|acute plyometric exercise
15918400|NCT03509818|Other|Aerobic exercise|acute aerobic exercise
15918401|NCT03509805|Diagnostic Test|polysomnography|
15918402|NCT03509792|Behavioral|Simple cognitive task|"A memory cue followed by playing the computer game Tetris on own smartphone. Options to engage in self-administered booster sessions after day 1."
15918403|NCT03509792|Behavioral|Attention placebo|Smartphone activity for same amount of time.
15918404|NCT03509766|Device|Histamine skin testing|skin testing using histamine
15918405|NCT03509753|Dietary Supplement|High Fiber|See intervention description.
15918406|NCT03509753|Dietary Supplement|Low Fiber|See intervention description.
15918407|NCT03509740|Drug|tramadol|100 mg tramadol in 100 ml saline with slow infusion
15918408|NCT03509740|Drug|paracetamol|Intravenous 1 gm paracetamol in 100 ml saline with slow infusion
15918409|NCT03509714|Dietary Supplement|Jubilance (100 mg Oxaloacetate/150 mg Ascorbic Acid)|2 Pills to be taken orally per day during their entire menstrual cycle
15918410|NCT03509714|Dietary Supplement|rice flour (Placebo)|250 mg rice flour (Placebo)
15918411|NCT03509701|Diagnostic Test|VZV-specific antibody response from blood|Check VZV-specific antibody response, VZV specific T-cell mediated immune response by IFN-γ ELISPOT assay from blood, and real-time PCR results from saliva
15918412|NCT03509688|Drug|entecavir+resveratrol|entecavir+resveratrol
15918413|NCT03509688|Drug|Entecavir|Entecavir
15918414|NCT03509688|Drug|entecavir+thymosin α1|entecavir+thymosin α1
15918415|NCT03509675|Drug|Ibuprofen suspension 5mg/100ml|Non-Steroidal Anti-inflammatory Topical Rinse will be used for Symptomatic OLP patients.
15918416|NCT03509675|Drug|Placebos|Placebo
15918417|NCT03509662|Drug|Vitamin C|Vitamine C will be administered intravenously as ascorbic acid (ascorbinezuur CF 100 mg/ml, Centrafarm BV, Etten Leur, Netherlands).
15918418|NCT03509662|Drug|Thiamine|All patients will receive thiamine 200 mg q 12 hourly for 4 days to limit the conversion of vitamin C to oxalate.
15918419|NCT03509662|Drug|Placebos|One group receives a placebo.
15918420|NCT03509649|Procedure|Cervical spine manipulation|High-velocity low-amplitude thrust joint manipulation to the cervical spine
15918422|NCT03509623|Diagnostic Test|Blood sampling through direct peripheral venous puncture|Fasting blood samples will be collected 10-15 minutes before the first intravitreal injection of aflibercept and at 7 and 30 days post-injection using a 19-gauge needle under minimum stasis. Blood coagulation parameters will be evaluated.
15918423|NCT03509610|Other|Diet|Macronutrient composition (specifically type and/or amount of carbohydrate) is manipulated
15918424|NCT03509597|Behavioral|Aerobic Exercise|Physical exercise training consisting of aerobic exercise and strength/resistance training.
15918425|NCT03509597|Behavioral|Cognitive Training|Cognitive remediation program using REHACOP rehabilitation program.
15918426|NCT03509597|Behavioral|Treatment as usual|Standard care for schizophrenia + Leisure and free time activities.
15918427|NCT03509597|Behavioral|Occupational Activities|Engagement in activities aimed to keep patients actively involved in demanding tasks.
15918428|NCT03509584|Radiation|hypofractionated radiotherapy|Stereotactic hypo-fractionated irradiation (3 x 8 Gys) radiotherapy fraction
15918429|NCT03509584|Drug|nivolumab|administration of nivolumab
15918430|NCT03509584|Drug|Ipilimumab|administration of ipilimumab
15918433|NCT03509558|Device|Transcutaneous spinal stimulation|Non-invasive electrical stimulation of spinal cord over the skin combined with physical therapy to improve walking and standing functions
15918436|NCT03509545|Drug|CHF Patients: Furosemide 40 mg|Stable CHF patients taking twice-daily 40 mg Furosemide
15918437|NCT03509532|Device|PCI|PCI
15918438|NCT03509519|Other|NMES-Millicurrent|Stimulating electrodes will be applied to the quadriceps muscle of each leg 3 times a week for 4 weeks (12 sessions) for 40min per leg.
15918439|NCT03509506|Behavioral|App Group|"The participants will be educated to use the HFHS application to monitor their daily vital signs (HR, BP, body weight), physical activity, and medications for 4 weeks.
~The research team will monitor their data entry remotely via the HFHS App. The team will text the participant via the App if one or more of following conditions is noted:
~The vital signs show undesired readings
~The records on the HFHS App show that the participant did not take the medications as the schedule says
~In addition, the team will call the participant 3 days later to follow up regarding the participant's action towards the text message that the team sent."
15918440|NCT03509493|Diagnostic Test|FibriCheck|Digital health application
15918441|NCT03509480|Procedure|Surgical Curettage for benign bone lesion|Surgical curettage for benign bone lesion, created defects will be filled with one of two types of graft material Vitoss versus Prodense, there are no other devices or drugs used
15918445|NCT03509428|Behavioral|SRETP|SRETP will involve short periods of exercise at a high intensity interspersed with short periods of exercise at a moderate intensity (aerobic interval training). We will also include resistance training in each session. Exercise intensities during the interval exercise-training program are specific to each patient and derived from CPET. Moderate intensity exercise is below the anaerobic threshold (AT). Patients will exercise at 80% of oxygen uptake (VO2) obtained at the anaerobic threshold (80%AT) for moderate intensity exercise - 3 minutes. Severe exercise intensity is recognised as 50% of the difference between the VO2 AT and VO2 Peak (50%∆) - 2 minutes.
15918446|NCT03509428|Behavioral|Psychological support|Support sessions will be patient-centred, giving the patient an opportunity to raise any issues/concerns they are having, this may include (but will not be limited to) ways of coping with their reactions to cancer, family and relationship issues, exploring personal issues and dealing with practical issues. Patients will have access to other resources available at the cancer centres including but not restricted to further information about their condition and how to access financial support. These processes reflect the best practice currently being delivered by cancer support centre staff in the Wessex region. Any patient deemed at risk (i.e. from suicidal ideation or self harm) will be reported to their GP, followed up by a letter.
15918447|NCT03509415|Diagnostic Test|In-vivo imaging|Skin cancer is imaged using RCM and a diagnosis is recorded before patient is returned to standard of care (biopsy).
15918448|NCT03509402|Device|ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm|Rehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal short implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: 6 mm)
15918449|NCT03509402|Device|ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm|Rehabilitation of the edentulous mandible by a full-arch srew-retained prosthesis with distal cantilevers supported by five interforaminal long implants (ASTRA TECH Implant System, OsseoSpeed™ 4.0 S, length: ≥11mm)
15918450|NCT03509376|Procedure|Suture repair|The diastasis is repaired with continous nylon suture
15918451|NCT03509376|Procedure|Rolled mesh repair|Continuous nylon suture is done over a narrow strip of self gripping Rolled mesh to repair the diastasis
15918452|NCT03509363|Behavioral|Stroke physiotherapy home exercise video|a set of exercise video with QR code provided in home exercise pamphlets
15918453|NCT03509350|Drug|Vitamin C|Intravenous vitamin C (1.5 grams every 6 hours) will be administered for 4 days or until ICU discharge.
15918454|NCT03509350|Drug|Thiamine|Intravenous thiamine (100 mg every 6 hours) will be administered for 4 days or until ICU discharge.
15918455|NCT03509350|Drug|Hydrocortisone|Intravenous hydrocortisone (50 mg every 6 hours) will be administered for 4 days or until ICU discharge.
15918456|NCT03509350|Drug|Vitamin C Placebo|A placebo to match intravenous vitamin C (1.5 grams every 6 hours) will be administered for 4 days or until ICU discharge.
15918457|NCT03509350|Drug|Thiamine Placebo|A placebo to match intravenous thiamine (100 mg every 6 hours) will be administered for 4 days or until ICU discharge.
15918458|NCT03509350|Drug|Hydrocortisone Placebo|A placebo to match intravenous hydrocortisone (50 mg every 6 hours) will be administered for 4 days or until ICU discharge. Steroids will be used when clinically indicated.
15918459|NCT03509337|Diagnostic Test|shear-wave elastography|Measurement by shear-wave elastography of the nerve, muscle and ulnar tendon before and after the tension of the ulnar nerve
15918460|NCT03509324|Drug|Insulin LISPRO|receive short-term insulin pump therapy by using insulin LISPRO, continue treatment for 7 more days when euglycemia achieved
15918461|NCT03509298|Biological|Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Pancreatic Cancer|CIK cells was activated by PD-1 inhibitor and bispecific antibody of anti-CD3/MUC1
15918462|NCT03509298|Procedure|cryotherapy|the maximum tumor length≥2 cm，cool down the lesion,result in degeneration, necrosis or loss of the lesion.
15918463|NCT03509285|Drug|Alprazolam Placebo|100 mg lactose tablets
15918464|NCT03509285|Drug|Cenobamate placebo|Sugar pill manufactured to mimic cenobamate 100 mg tablet
15918465|NCT03509285|Drug|Alprazolam|0.5 mg and 1.0 mg alprazolam tablets
15918466|NCT03509285|Drug|Cenobamate|100 mg tablet
15918493|NCT03509025|Drug|Jointstem|JOINTSTEM is an OA treatment that uses autologous adipose-derived mesenchymal stem cells. As it does not use allogenic tissues and is incubated without additional genetic modification or mechanical and chemical modification through differentiation, it is classified as 'autologous cell therapy' and is completely free of immunologic rejection.
15918494|NCT03509012|Drug|Durvalumab|IV (intravenous)
15918495|NCT03509012|Drug|Tremelimumab|IV
15918467|NCT03509272|Device|remote monitoring|"Intervention Description: Patients can participate in the study when they're 10 weeks pregnant. At 10 weeks: a NICCOMO, Maternal Venous Doppler Echography and Maltron measurement will be taken. This measurement will be repeated at 20 weeks of pregnancy, and 30 weeks of pregnancy when they're aberrant.
~When the measurements are abnormal, the patients will be included in the remote monitoring study. The following protocol and devices will be applied:
~Device What When Withings Wireless Blood Pressure Monitor Blood Pressure 2x/day Withings Pulse O² Activity Day and night Withings Smart Body Analyzer Weight
~1x/day"
15918468|NCT03509246|Drug|Pegylated liposomal doxorubicin plus Bortezomib|Pegylated liposomal doxorubicin 40mg/m2 subcutaneous for 60 - 90 minutes at day 4 plus Bortezomib 1.3mg/m2 subcutaneous injection at day 1,4,8,11 for 6 cycles
15918469|NCT03509233|Other|Q-SRP|Quadrant scaling and root planing under local anesthesia using ultrasonic devices (Piezon-Master, EMS) and Gracey curettes (Hu-Friedy) within four sessions in intervals of 1 week
15918470|NCT03509233|Other|FMS|Full mouth scaling and rootplaning under local anesthesia using ultrasonic devices (Piezon-Master, EMS) and Gracey curettes (Hu-Friedy) within 24 hours
15918471|NCT03509233|Other|FMD|Full mouth scaling and rootplaning under local anesthesia using ultrasonic devices (Piezon-Master, EMS) and Gracey curettes (Hu-Friedy) within 24 hours with additional disinfection using 0.2% chlorhexidine (mouth rinsing and tonsil spray), subgingival application of 1% chlorhexidine gel and 2 months postoperative home care using chlorhexidine 0.2% (rinse and spray)
15918472|NCT03509233|Other|FMDP|FMD protocol (see FMD arm) with additional use of subgingival airpolishing (Air Flow, EMS) using Erythritol powder (Air-Flow Plus powder, EMS) for 20 seconds per tooth
15918473|NCT03509220|Drug|PBK-1701TC|The subject will receive PBK-1701TC for colonoscopy.
15918474|NCT03509220|Drug|Standard oral preparation|The subject will receive the standard oral preparation for colonoscopy
15918475|NCT03509207|Drug|Vorinostat Oral Capsule|Vorinostat, 400 mg orally once daily for the first 14 days of a 21 day cycle Treatment will be continued for 4 cycles. Patients with a response or stable disease after 4 cycles will be continued on vorinostat therapy at the tolerated schedule and dosage until disease progression, unacceptable toxicity or patients' withdrawal of the consent. At the maximum, a total of 12 cycles will be administered over a period of 9 months.
15918476|NCT03509181|Behavioral|I-Change|smartphone delivered word-sentence association task that encourages a healthier interpretive style
15918477|NCT03509181|Behavioral|Symptom Tracking|smartphone delivered self-monitoring of anxiety and depression symptoms
15918478|NCT03509168|Drug|Misoprostol Pfizer Brand|insertion of a preoperative single dose 400 micrograms of Misoprostol Pfizer Brand placed vaginally
15918479|NCT03509168|Other|Non-insertion of Misoprostol Pfizer Brand|participants in this arm will receive the standard of care which in our setting involves the use of either a tourniquet to control intraoperative blood loss especially if the fibroids are large or rarely, other interventions like oxytocin, tranexamic acid, vasopressin and occasionally not using either of the interventions.
15918480|NCT03509155|Other|National portion & IYCF counseling|Eight or twelve pieces of Biscuits supplementation per day as serving size recommendation based on the requirement from Ministry of Health, accompanied by IYCF Counseling emphasizing on local food optimization. The difference in serving size recommendation will be evaluated to see the efficacy of Biscuits supplementation on wasting children age 6-23 months of age
15918481|NCT03509155|Other|Adjusted portion & local food counseling|four pieces of Biscuits supplementation per day as serving size recommendation, accompanied by IYCF Counseling. The difference in serving size recommendation will be evaluated to see the efficacy of Biscuits supplementation on wasting children age 6-23 months of age
15918482|NCT03509142|Device|Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System|Implantation of Sirolimus-eluting Iron Bioresorbable Coronary Scaffold System (IBS)
15918483|NCT03509129|Behavioral|TECH (Technology)|"Participants will receive a theory-based physical activity program. They will enroll in the study as part of a self-selected group of 3-8 individuals. They will be provided with a personal step goal and Fitbit Alta HR for self-monitoring physical activity. They will also have access to a study website that will be accessible across conventional and mobile platforms. They will be asked to visit the website each week to receive behavior change information and guidance.
~Device: Fitbit Alta HR"
15918484|NCT03509129|Behavioral|TECH+COMP (Technology + Competition)|"Participants will receive the same intervention components as the TECH group, as well as a team competition. The competition will be based on the following two aspects: total daily steps accumulated relative to group size and total number of points retained for achieving weekly physical activity challenges.
~Device: Fitbit Alta HR"
15918485|NCT03509116|Other|Observations|Consultation observations
15918486|NCT03509116|Other|Interviews, key stakeholders, documents|Qualitative interviews, key stakeholders, documentary analysis
15918487|NCT03509103|Other|Electronic Partograph|"The electronic version of the partograph was a state-of-the-art application that is accessed through smart phone or tablet pc or computer device. The application's user interface (UI) is segmented; users will have to concentrate only on a single portion at a time that would lessen the existing complexity of using paper-based partograph.
~e-partograph application's user interface in Android programming language for smart tabs, and in ASP.net with C# language for personal computers. The application has options to save the data in local storage and in a remote central database storage concurrently. Local storage contains data for temporarility; the remote server contains the data permanently which makes the partograph information searchable at any time and place. This application allows partograph data to be monitored remotely."
15918488|NCT03509090|Procedure|erector spinae block|erector spinae block will be performed in this group as postoperative analgesia treatment.
15918489|NCT03509090|Procedure|Control group|patients will receive only multimodal analgesic treatment including patient-controlled analgesia
15918490|NCT03509064|Other|Collection sheet|Using EQ5D questionnaire and a collection of care resources consumed by the patients during a period of 6 months associated by using validated scales (SF36, DN4, PROFAD SSI, ESPRI) : collection sheet
15918491|NCT03509051|Biological|B vaccination|One intramuscular injection of Bexsero (multicomponent B vaccine) from 6 months after transplant. A second similar dose will be given 2 months later.
15918492|NCT03509038|Other|Exploratory pathophysiology Study|Urodynamic tests before and after bariatric surgery in obese incontinent women before and after bariatric surgery
15918496|NCT03509012|Drug|Cisplatin (dose level 4)|IV
15918509|NCT03509012|Radiation|External beam radiation (standard)|radiation therapy
15918510|NCT03508999|Drug|Metronidazole gel|The application of metronidazole gel is effective in the management of gingivitis in patients undergoing orthodontic therapy. Additionally, the constant reminder therapy at weekly interval would also lead to improvement in the oral hygiene.16 According to pertinent literature survey, none of the study has been conducted to compare the effectiveness of SMS reminders and use of anaerobic gel to reduce gingival inflammation.
15918511|NCT03508999|Other|SMS text reminder|Subjects will be provided biweekly reminder via 'SMS text reminder' in the form of text message reinforcing oral hygiene. Additionally, patients will be given standard oral hygiene instructions on the visit with a placebo gel topically instructed to apply on the marginal gingiva for the next 4 weeks, twice a day for 30 minutes, after morning and evening tooth brushing.
15918512|NCT03508999|Other|Placebo gel|Group C will be subjects will be given standard oral hygiene instructions on the visit with a placebo gel topically instructed to apply on the marginal gingiva for the next 4 weeks, twice a day for 30 minutes, after morning and evening tooth brushing.
15918513|NCT03508973|Other|Sculpta|
15918514|NCT03508947|Drug|WVE-210201|WVE-210201 is a stereopure antisense oligonucleotide (ASO)
15918515|NCT03508947|Drug|Placebo|Sodium Chloride
15918516|NCT03508934|Device|GTS (Continuous Glucose Monitoring)|Hospitalized patients with DM2 will be monitored with Glucose Telemetry System (GTS)
15918517|NCT03508934|Other|POC (Point of Care)|Hospitalized patients with DM2 will be monitored with POC (Point of Care) blood glucose levels.
15918518|NCT03508921|Procedure|Periprocedural Antibiotics|"One the day of injection, after eligibility is determined and consent obtained, research staff will refer to the randomization list to determine to which arm the patient is randomized. Patients randomized to the Procedural Antibiotics Only arm will receive a single dose of trimethoprim/sulfamethoxazole (800/160mg) peri-procedurally at the time of the first injection."
15918519|NCT03508921|Drug|Extended Antibiotics|"Patients randomized to the Extended Antibiotics arm will receive one dose of trimethoprim/sulfamethoxazole peri-procedurally and additionally be prescribed trimethoprim/sulfamethoxazole twice daily for three days. Patients who are allergic will receive amoxicillin/clavulanic acid (875/125mg) twice daily for three days. If allergic to both of the above antibiotics, patients will receive 100mg nitrofurantoin BID for three days.
~For their second injection, they will receive peri-procedural antibiotics only."
15918520|NCT03508921|Procedure|Injection of OnabotulinumtoxinA (BTX-A)|Patients will receive injection of OnabotulinumtoxinA (BTX-A) per standard clinic practice protocol. All patients will undergo injection per a standardized protocol of 1ml injection per site at a concentration of 10 units/ml.
15918521|NCT03508908|Diagnostic Test|HIV-1 RNA testing|During the intervention period, a blood sample will be obtained and tested for AHI using point-of-care Xpert® HIV Qual assay (Cepheid, Sunnyvale, California, USA). Individuals who test positive will undergo rapid tests to differentiate acute from prevalent HIV infection. Newly diagnosed individuals will be offered immediate ART and assisted partner notification with the HIV-1 RNA testing intervention delivered to partners following the same approach.
15918522|NCT03508895|Other|Whole hemp seed protein|The intervention will be provided in a form of a smoothie.
15918523|NCT03508895|Other|Whole hemp seed protein plus bioactive peptides|The intervention will be provided in a form of a smoothie.
15918524|NCT03508895|Other|Casein protein|The intervention will be provided in a form of a smoothie.
15918525|NCT03508882|Drug|Botulinum Toxin Type A 100Unit/Vial (Product)|Botulinum Toxin Type A 100Unit/Vial (Product) comes as a dry powder and is routinely reconstituted with Saline Solution for Injection
15918526|NCT03508882|Drug|Saline Solution for Injection|The placebo consists of vehicle only. Saline Solution for Injection is the vehicle substance normally used to reconstitute Botulinum Toxin Type A (see 1st Intervention above).
15918527|NCT03508869|Drug|Mirvaso® (brimonidine) topical gel, 0.33%|Mirvaso® (brimonidine) topical gel, 0.33% is an alpha adrenergic agonist indicated for the topical treatment of persistent facial erythema of rosacea in adults 18 years of age or older.
15918528|NCT03508869|Drug|Dysport®|Dysport® is an acetylcholine release inhibitor and a neuromuscular blocking agent.
15918529|NCT03508869|Drug|Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%|Dysport® in conjunction with Mirvaso (brimonidine) topical gel, 0.33%
15918530|NCT03508856|Drug|Ingenol Mebutate (Picato®) 0.015% gel|
15918531|NCT03508843|Behavioral|interactive virtual presence|installing the car seat with advice via interactive virtual presence
15918532|NCT03508830|Drug|Liposomal bupivacaine|5cc of drug preparation will be percutaneously injected into each intercostal space 3-10 under direct intrathoracic vision and subcutaneously into each surgical wound at the conclusion of the surgery.
15918533|NCT03508830|Drug|Bupivacaine Injection|5cc of drug preparation will be percutaneously injected into each intercostal space 3-10 under direct intrathoracic vision and subcutaneously into each surgical wound at the conclusion of the surgery.
15918534|NCT03508817|Drug|Atropine Sulfate 0.01% Eye Drops|atropine eye drop in study eye once nightly for two years.
15918535|NCT03508804|Drug|Lidocaine-Prilocaine Cream|10ml of vaginally self-administered cream composed of an eutectic mixture of 2.5% lidocaine, 2.5% prilocaine
15918536|NCT03508804|Drug|Placebo Cream|10ml of vaginally self-administered placebo cream
15918537|NCT03508804|Drug|1% Lidocaine Paracervical Block|Paracervical block of 10ml of 1% lidocaine
15918538|NCT03508791|Other|Arterial carbon dioxide monitoring|Arterial carbon dioxide partial pressure is monitored during the laparoscopic surgery undergoing in the Trendelenburg or reverse Trendelenburg positions.
15918539|NCT03508791|Other|End-tidal carbon dioxide monitoring|End-tidal carbon dioxide partial pressure is monitored during the laparoscopic surgery undergoing in the Trendelenburg or reverse Trendelenburg positions.
15918540|NCT03508791|Other|Transcutaneous carbon dioxide monitoring|Transcutaneous carbon dioxide partial pressure is monitored during the laparoscopic surgery undergoing in the Trendelenburg or reverse Trendelenburg positions.
15918541|NCT03508778|Device|FluidVision AIOL|Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject
15918542|NCT03508778|Device|AcrySof IQ PanOptix Trifocal IOL|Commercially available implantable medical device intended for long-term use over the lifetime of the cataract subject
15918543|NCT03508778|Procedure|Cataract surgery|Cataract surgery per investigator's standard practice
15918544|NCT03508765|Diagnostic Test|Structural Image|Patients will undergo structural and functional (rsfMRI) brain MRIs (total time= ~15 minutes) at enrollment (prior to HD-Chemo/ASCT) and approximately 3-4 months after ASCT.
15918545|NCT03508765|Diagnostic Test|Functional Image|Patients will undergo structural and functional (rsfMRI) brain MRIs (total time= ~15 minutes) at enrollment (prior to HD-Chemo/ASCT) and approximately 3-4 months after ASCT.
15918546|NCT03508765|Behavioral|Digit Span subtest|Evaluates auditory attention and working memory
15918547|NCT03508765|Behavioral|Brief Test of Attention|Assesses selective auditory attention
15918548|NCT03508765|Behavioral|Trail Making Test (Parts A & B)|Assesses visual scanning, graphomotor speed, and setshifting
15918549|NCT03508765|Behavioral|Auditory Consonant Trigrams Test|Assesses attention and susceptibility to interference
15918550|NCT03508765|Behavioral|Controlled Oral Word Association Test|A timed test of verbal fluency.
15918551|NCT03508765|Behavioral|Hopkins Verbal Learning Test-Revised|The HVLT-R is a test of verbal learning and recall.
15918552|NCT03508765|Behavioral|The Center for Epidemiological Study-Depression|assesses perceived depression
15918553|NCT03508765|Behavioral|The Functional Assessment of Chronic Illness Therapy-Fatigue Subscale, Version 4|A 13-item questionnaire designed to assess symptoms and concerns specific to the QOL of patients with fatigue
15918554|NCT03508765|Other|Blood draw|Blood samples will be collected at each time point (pre-ASCT; 3-4 months and post-ASCT) to assess serum levels of inflammatory cytokines.
15918555|NCT03508752|Radiation|Stereotactic Radiosurgery|Stereotactic Radiosurgery dose is based on the largest tumor size
15918556|NCT03508739|Drug|Sacubitril/Valsartan 200mg (blinded)|study day 2 for AB and study day 3 for BA
15918557|NCT03508739|Drug|Valsartan 160mg (blinded)|study day 3 for AB and study day 2 for BA
15918558|NCT03508726|Drug|Ascorbate|"Phase 1 dose escalation:
~75gm IV three times a week
~Phase II portion:
~75gm IV three times a week if no dose limiting toxicities are experienced in the Phase I portion. Otherwise, ascorbate dose will be deescalated to 62.5 gm IV"
15918559|NCT03508713|Drug|disease modified antirheumatic drugs or biological agents|Enrolled patients will be treated according to the 2015 American College of Rheumatology Guideline for the Treatment of RA
15918560|NCT03508700|Drug|TNX-102 SL 5.6 mg|cyclobenzaprine HCl sublingual tablets
15918561|NCT03508687|Drug|300mg Gemcabene|300mg Gemcabene
15918562|NCT03508687|Drug|600mg Gemcabene|600mg Gemcabene
15918563|NCT03508674|Device|Levita Magnetic Surgical System|use of surgical tool
15918564|NCT03508661|Other|SPIN-SSLED Program|The program includes 13 modules that will be delivered live via webinar over the course of the 3-month program. Each module will be delivered in a 60- to 90-minute session. Module topics include (1) the leader's role; (2) starting a support group; (3) structuring a support group meeting; (4) scleroderma 101; (5) successful support group culture; (6 &7) managing support group dynamics I and II; (8) grief and crisis in scleroderma; (9) marketing and recruitment; (10) the continuity of the group; (11) supporting yourself as a leader; (12) virtual support group meetings, (13) support group leader resources. Participants will receive a workbook, be shown filmed vignettes, and will have access to an online resource center.
15918565|NCT03508648|Drug|GTx-024|Subjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002.
15918566|NCT03508648|Drug|Matching Placebo|Subjects will not be provided with any study treatments and will be off-drug during this extension study. Intervention was administered during study G201002.
15918567|NCT03508635|Drug|CORT125134|Oral capsules
15918568|NCT03508635|Drug|Matching Placebo of CORT125134|Placebo
15918569|NCT03508635|Drug|Mifepristone|Active comparator
15918570|NCT03508635|Drug|Prednisone|Challenge agent
15918571|NCT03508635|Drug|Glucose|
15918572|NCT03508622|Behavioral|Telehealth group sessions|Telehealth sessions will utilize an online meeting platform and will be conducted by RDs, PTs, psychologists, and MDs, to deliver weight management information/counseling, to group of 5-6 14-18 yos with obesity.
15918573|NCT03508622|Behavioral|Empower clinic|Empower visits for the retrospective control group were multi-disciplinary in nature, occurred at CHLA outpatient clinic, and were intended to be monthly (though actual adherence to recommended attendance was variable). Teen and minimum of one family member were asked to attend monthly visits, as per our standard clinical care.
15918574|NCT03508609|Biological|CLBS16|GCSF-mobilized autologous CD34 cells
15918575|NCT03508596|Other|educational intervention for the supervisors|The educational intervention is based on a systematic literature review as well as focus-group interviews with health care professionals. It will be developed until the end of 2018
15918576|NCT03508583|Other|Participation|"The mpoc 56 and mpoc 20 will be field-tested with a sample of 300 parents of children with disabilities residing in the Turkey.
~Professionals working with children with disabilities will be assessed with MPOC SP questionnaires"
15918577|NCT03508570|Biological|Ipilimumab|Given i.p.
15918578|NCT03508570|Other|Laboratory Biomarker Analysis|Correlative studies
15918579|NCT03508570|Biological|Nivolumab|Given i.p.
15918580|NCT03508570|Other|Pharmacokinetic Study|Correlative studies
15918581|NCT03508557|Behavioral|Advance care planning tools|Structured conversations between patients/substitute decision-maker and clinician based on education about advance care planning using locally relevant booklet/website, values clarification tool for patient engagement, clinician use of the Serious Illness Conversation Guide
15918582|NCT03508544|Procedure|Lumbar ESP block|Lumbar ESP block will be performed at the begining of surgery under ganeral anesthesia. A convex ultrasound transducer will be placed in a longitudinal parasagittal orientation 4-6 cm lateral to L4 spinous process. The erector spinae muscles will be identified superficial to the tip of L4 transverse process. The patient's skin will be anesthetized with 2% lidocaine. A 22-gauge 10-cm needle will be inserted using an out-plane superior-to-inferior approach to place the tip into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process. A total of 40 mL of bupivacaine/lidocaine mixture will be injected.
15918710|NCT03507465|Drug|EC-T|Epirubicin/Cyclophosphamide Followed by Docetaxel
15919094|NCT03504527|Drug|triple combinations|inhaled budesonide(160ug,bid),formotero(4.5ug,bid) and tiotropium bromide(18μg,qd)
15918583|NCT03508544|Procedure|QLB bLock|QLB block will be performed at the begining of surgery under ganeral anesthesia. The convex transducer will be placed in the transverse plane on the flank of the patient cranial to the iliac crest.The 4th lumbar vertebral transverse process, erector spinae muscles, psoas muscles, transverse abdominis muscles, internal and external oblique muscles and the quadratus lumborum muscles will be identified. A 15cm 22G insulated needle will be inserted on the posterior corner of the convex probe. 40 ml of local anesthetic mixture(bupivacaine and lidocaine ) will be administered between the quadratus lumborum and psoas muscles into the fascial plane. We observed the local anesthetic pressing down on the psoas muscle in the ultrasound image.
15918584|NCT03508544|Other|Standard Pain Followup and Monitorization|Numeric Rating Scale (NRS) pain score will be recorded from 20th minute in recovery room followed by 1.-3.-6.-12.-18.-24.hours. Intravenous meperidine administration at 0.5 mg / kg rescue analgesia was determined in patients with a NSR score of 6 and over in the postoperative collection room. It is planned that the patient will continue to follow the hourly NRS score in ward. Intramuscular diclofenac will be administered in this period if NRS 6 and if it is over, intravenous 0.5 mg / kg meperidine will be administered if NRS score is 6 or more after 2 hours. Salvage analgesic needs and times will be noted in detail, and the use of rescue analgesics, as well as NRS scores at designated hours, will be kept in a statistical evaluation.
15918585|NCT03508531|Procedure|ESP Block|A high-frequency linear ultrasound transducer will be placed in a longitudinal parasagittal orientation 3 cm lateral to T9 spinous process. The erector spinae muscles will be identified superficial to the tip of T9 transverse process. The patient's skin will be anesthetized with 2% lidocaine. A 17-gauge 8-cm needle will be inserted using an in-plane superior-to-inferior approach to place the tip into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process. A total of 40 mL of bupivacaine/lidocaine mixture will be injected.
15918586|NCT03508531|Procedure|OSTAP block|The bilateral OSTAP will be performed at the end of the surgery. A total of 40 ml local anesthetic mixture (Bupivacaine and lidocaine) will be injected bilaterally with interfascial plane between the external oblique and transversus abdominis muscles
15918587|NCT03508531|Other|Standard Pain Followup and Monitorization|Numeric Rating Scale (NRS) pain score will be recorded from 20th minute in recovery room followed by 1.-3.-6.-12.-18.-24.hours. Intravenous meperidine administration at 0.5 mg / kg rescue analgesia was determined in patients with a NSR score of 6 and over in the postoperative collection room. It is planned that the patient will continue to follow the hourly NRS score in ward. Intramuscular diclofenac will be administered in this period if NRS 6 and if it is over, intravenous 0.5 mg / kg meperidine will be administered if NRS score is 6 or more after 2 hours. Salvage analgesic needs and times will be noted in detail, and the use of rescue analgesics, as well as NRS scores at designated hours, will be kept in a statistical evaluation.
15918588|NCT03508518|Other|Shared care device in psychiatry (DSPP)|The GPs of the intervention group will be able to refer their patients to the DSPP or to the routine care. The patient has a nursing telephone interview prior to one or few more psychiatric consultations. The time to obtain the psychiatric consultation is measured into the 2 groups. In both groups, questionnaires will be sent to the patient and their medico-administrative data will be collected passively over a period of 6 months after inclusion
15918589|NCT03508518|Other|Usual Care|psychiatric care available in the Haute Garonne: psychiatric consultation by a liberal psychiatrist or by a psychiatrist working in public health center.
15918590|NCT03508505|Device|Venoarterial extracorporeal oxygenation|Veno-arterial extracorporeal oxygenation (VA-ECMO) is inserted in the acute setting in case of cardiac low output after adult cardiac surgery in order to provide cardiopulmonary support to recovery or as bridge to transplantation.
15918591|NCT03508492|Other|Surgical tinted Chloraprep® applicators|We randomized knee, hip, cardiac and colon surgeons making them using two applicators of each brand in four of theirs surgeries. Randomization will be carried out in blocks of four for each surgeon.
15918592|NCT03508492|Other|Surgical tinted Nex Clorex 2% applicators|We randomized knee, hip, cardiac and colon surgeons making them using two applicators of each brand in four of theirs surgeries. Randomization will be carried out in blocks of four for each surgeon.
15918593|NCT03508479|Biological|RG-HRV16|0.25 mL inoculum intranasally delivered into each nostril (0.5 mL total delivered). Total cumulative dose of 1000 median tissue culture infective dose at 50% of cells inoculated (TCID50).
15918594|NCT03508466|Behavioral|hypersensitivity reaction|Previous hypersensitivity reaction
15918595|NCT03508453|Biological|IC14|Monoclonal antibody against CD14
15918596|NCT03508453|Other|Placebo|sterile normal saline for injection prepared to be identical to study drug
15918597|NCT03508440|Procedure|Intratympanic injection|Injection will be up to 1cc of dexamethasone 24mg/mL. The procedure will be performed at supine position under a microscope. Local anesthesia will be achieved with topical phenol. A myringotomy will be made in the tympanic membrane. A 1 mL syringe connected to a needle will be used to slowly inject between 0.2 cc and 1.0 cc of solution through the myringotomy, with the subject's head turned 45 degrees to the opposite side. The subject will be asked to maintain positioning for at least 30 minutes and refrain from swallowing. The dose administered will vary due to subject-specific factors.
15918598|NCT03508440|Drug|Prednisone|Oral Steroid
15918599|NCT03508427|Other|Daily self-monitoring|Toi Même self-monitoring smartphone application plus treatment as usual which includes pharmacological and/or psychological treatment.
15918600|NCT03508414|Behavioral|ketogenic diet|Patients receive a ketogenic diet, which is carbohydrate-reduced with a high amount of fat.
15918601|NCT03508414|Behavioral|Intermittent therapeutical fasting|Patients fast for 1 week every six months. Additionally, the patients do an intermittent fasting, that is to say they do not eat for at least 14 hours a day.
15918602|NCT03508414|Behavioral|Active comparator|The control group is receiving a vegetarian-focused diet according to the current recommendations of the German Society for Nutrition (DGE) for MS patients.
15918603|NCT03508401|Other|Passive leg raising (PLR)|"PLR is a test that predicts whether cardiac output will increase with volume expansion. By transferring a volume of around 300 mL of venous blood from the lower body toward the right heart, PLR mimics a fluid challenge. However, no fluid is infused and the hemodynamic effects are rapidly reversible, thereby avoiding the risks of fluid overload.
~PLR starts from the semi-recumbent and not the supine position. PLR is performed by adjusting the bed and not by manually raising the patient's legs"
15918604|NCT03508401|Device|Echo-Doppler measurements|"Echo-Doppler measurements are performed with Vivid S6 model (GE Healthcare France, Lyon, France). All measurements are recorded at the end of expiration. Echo-Doppler measurements are performed in the upper part of the SVC, approximately 1 to 2 cm below the brachiocephalic vein. From this view, pulse Doppler is performed. Pulse Doppler waves obtained in the SVC are used to obtain velocity time integrals (VTI). Expiratory VTI is named VTImax and inspiratory VTI is named VTImin. These values will allow the calculation of Respiratory variations of the superior vena cava flow (ΔSVCf).
~ΔSVCf is calculated as (VTImax- VTImin )/(1/2(VTImax+ VTImin))."
15918605|NCT03508375|Biological|blood samples|blood samples
15918606|NCT03508362|Device|Functional Magnetic Resonance Imaging (fRMI)|Acquisition of a functional MRI on the sub thalamic nucleus
15918607|NCT03508349|Diagnostic Test|IST|Women in the control group will receive routine care, which does not include testing for malaria with a rapid diagnostic test unless symptomatic for malaria. Women in the intervention group will receive this additional testing for malaria at each antenatal care, regardless of whether she is symptomatic for malaria.
15918608|NCT03508336|Diagnostic Test|Coma Recovery Scale-Revised|"Patients with disorders of consciousness were assessed by Coma Recovery Scale-Revised (CRS-R). In addition, we selected four stimuli: 1) only a command (as recommended in CRS-R), which was open your mouth; 2) only a spoon without a command; 3) a spoon and a command, the command was there is a spoon and open your mouth; 4) a spoon with water and a command, the command was there is a spoon with water and open your mouth. In brief, we presented these stimuli orderly in front of the patient's mouth and presented any one of them over 4 trials at 15 second intervals."
15918609|NCT03508323|Drug|Teneligliptin|20mg/qd
15918610|NCT03508323|Drug|Placebo|1T/qd
15918611|NCT03508310|Other|Taking Care of Me Video|The video's conceptual framework incorporates Social Cognitive Theory, Information-Motivation-Behavioral Skills model, and Social Action Theory, which together address cognitive and behavioral factors related to study outcomes. Storylines embedded prevention messages aimed at increasing treatment initiation (n=9), medication adherence (n=35), retention in care (n=22), partner protection (n=12), and communication with health care providers (n=7).
15918612|NCT03508297|Diagnostic Test|In-vivo imaging|Skin cancer is imaged using RCM and a diagnosis is recorded before patient is returned to standard of care (biopsy).
15918613|NCT03508271|Other|Non-Interventional|Non-Interventional
15918614|NCT03508258|Other|Non-interventional|Non-interventional
15918615|NCT03508258|Other|Non-Interventional|Non-Interventional
15918616|NCT03508245|Other|Wearable short wavelength light therapy|Wearable short wavelength (i.e., blue-green) light-emitting glasses worn for two weeks
15918617|NCT03508232|Drug|Placebo|Patients will receive placebo in a loading dose of two capsules initially followed by one capsule every 12 hours for 7 days.
15918618|NCT03508232|Drug|Doxycycline Hyclate|Patients will receive doxycycline hyclate in a loading dose of two 100 mg capsules (200 mg total) initially followed by one 100 mg capsule every 12 hours for 7 days.
15918619|NCT03508219|Device|BiOSS LIM C|"The BiOSS LIM C (Bifurcation Optimization Stent System, Balton, Warsaw, Poland). The BiOSS LIM C is a dedicated bifurcation stent covered with a mixture of a biodegradable polymer and the antiproliferative substance sirolimus. BiOSS LIM C will be used for treatment of the Left-Main bifurcation, according to its instructions for use.
~The Alex-Plus cobaltchromium sirolimus eluting stent (Balton, Warsaw, Poland) will be used for treatment of distal left-main side branches according to its instructions for use (i.e. proximal segments of the left anterior descending and left circumflex arteries as well as the ramus intermedius if the latter vessel is part of a trifurcation).
~All other lesions (other than left-main bifurcations) will be treated with XIENCE family everolimus-eluting coronary stent systems."
15918620|NCT03508206|Dietary Supplement|SBRP|SBRP capsules
15918621|NCT03508206|Dietary Supplement|PLACEBO|Placebo capsules
15918622|NCT03508193|Other|Nutritional therapy|Whole-foods based smoothie designed to emulate formulas used in EEN
15918623|NCT03508180|Behavioral|INTERVIONNAL|"Foot reflexology session (30 minutes) each course of chemotherapy (total 4 courses) during the 4 hours following the first 2 hours of injection + auto-massage done by the patient between each course.
~During a session focused on the treatment of nausea / vomiting, the reflexologist will stimulate the reflex zones related to the digestive system in order to calm and stimulate all areas for deep relaxation of the patient."
15918624|NCT03508180|Other|CONTROL|None intervention.
15918625|NCT03508167|Device|Thermal Band|Thermal Band used 8 hours per day
15918626|NCT03508167|Drug|Dorilax®|"2 tablets, orally. In case of moderate pain, another 2 tablets could be administered, respecting the interval of 8 hours between the administrations.
~Maximum dosage per day: 6 tablets."
15918627|NCT03508167|Drug|Placebo|"2 tablets, orally. In case of moderate pain, another 2 tablets could be administered, respecting the interval of 8 hours between the administrations.
~Maximum dosage per day: 6 tablets."
15918628|NCT03508154|Other|Control Meal 1|carbohydrate test meal
15918629|NCT03508154|Other|Control Meal 2|carbohydrate test meal
15918630|NCT03508154|Other|Experimental Nutritional Product|ready to drink nutritional formulation
15918631|NCT03508141|Drug|Fibrinogen Concentrate|Experimental
15918632|NCT03508141|Drug|Cryoprecipitate|Comparator
15918633|NCT03508128|Other|surgical procedure|Surgical procedure
15918634|NCT03508102|Drug|remifentanil|the effects of remifentanil on the average value of BIS at the time period of before induction , induction , intubation , skin incision, peritoneum incision, uterine incision, and delivery
15918635|NCT03508089|Other|Ocular fundus on patient with Multiple Sclerosis|Ocular fundus on patient with Multiple Sclerosis
15918636|NCT03508089|Other|Ocular Fundus on voluntary person|Ocular Fundus on voluntary person
15918637|NCT03508076|Device|Vibrating Capsule|Patients in this group would be treated with Vibrating Capsule
15918638|NCT03508076|Device|Sham Capsule|Capsules can't vibrate but look the same as Vibrating Capsule
15918639|NCT03508050|Device|Clamping the Double Lumen Tube|Clamping the non-dependent lung's lumen of the double lumen tube during closed chest one-lung ventilation
15918711|NCT03507452|Drug|BAY2287411|"Dose Escalation part:
~A single dose will be administered intravenously on Day 1 of each cycle lasting 6 weeks (42 days)."
15918712|NCT03507452|Drug|BAY2287411|"Dose Expansion part:
~The selection of the dose level(s) /regimen(s) to be evaluated will be based on the overall benefit / risk and PK profile observed in the dose escalation."
15918640|NCT03508037|Other|Neuromodulation electroencephalographic signals and functional electrical stimulation based|First, the subject performs twenty reaching movements without assistance with the damaged arm resting on a robot (ArmeoSpring), with the aim of finding the Contingent Negative Variation (CNV). Then, he or she executes five courses of twenty movements receiving functional electrical stimulation (FES), either at the moment in which he or she wishes to move (experimental group), or half a second before or after (control group).
15918641|NCT03508011|Drug|IMP4297|The dose levels will be escalated following a modified 3+3 dose escalation scheme.
15918642|NCT03507998|Drug|CGX1321|CGX1321 capsules for oral administration
15918643|NCT03507985|Other|Two tests evaluating memory and attention|"The patient will perform two tests assessing memory and attention:
~Regarding attention, the test used will be the Stroop Color Word Test, developed to measure visual selective attention, cognitive flexibility and inhibition.
~For memory, the test used will be Rey's 15 words test. It provides an indicative standard for the evaluation of episodic verbal memory and learning abilities. This test was compared to the 16-item (18) free recall / booster test in normal aging and Alzheimer's dementia, and although it was more difficult, it . Since it allowed for the classification of participants from both groups without overlap"
15918644|NCT03507972|Radiation|ankle ultrasound|Ankle ultrasound performed during emergencies visit.
15918645|NCT03507972|Radiation|Member MRI|Member MRI (without injection of contrast product) performed within 7 days following the trauma
15918646|NCT03507959|Other|OLP scientifically-objective|Participants are informed that they are about to take a placebo. The rationale for the effectivity of placebos is explained in a scientifically-objective manner.
15918647|NCT03507959|Other|OLP personally-affective|Participants are informed that they are about to take a placebo. The rationale for the effectivity of placebos is explained in a personally-affective manner.
15918648|NCT03507959|Other|DP scientifically-objective|Participants are informed that they are about to take an effective antidepressant. The rationale for the effectivity of the antidepressant is explained in a scientifically-objective manner.
15918649|NCT03507959|Other|DP personally-affective|Participants are informed that they are about to take an effective antidepressant. The rationale for the effectivity of the antidepressant is explained in a personally-affective manner.
15918650|NCT03507946|Device|Dermawrap - combined 460nm, 633nm and 830nm LED therapy|Daily treatments of 15 minutes of combined LED phototherapy, 5 days per week for 12 weeks.
15918651|NCT03507920|Other|Neck passive mobilizations|Passive mobilizations performed to the neck of the participant by a Physiotherapist
15918652|NCT03507920|Other|Manual contact|Manual contact applied to the neck of the participant by a Physiotherapist
15918653|NCT03507907|Other|Mulligan Mobilization for Study Group|Mulligan Mobilization techniques were applied to the older adults who included in study group.
15918654|NCT03507907|Other|Conventional therapy for Control Group|Conventional therapy was applied to the older adults who included in control group.
15918655|NCT03507894|Behavioral|Multimodal Exercise Rehabilitation Program|Rehabilitation program based on aerobic exercise, task oriented activities, balance and stretching exercises complemented with a mobile app technology
15918656|NCT03507881|Device|fusion|Internal fixation
15918657|NCT03507868|Procedure|Nonsurgical periodontal therapy|Nonsurgical periodontal therapy includes oral hygiene education and scaling and root planning approaches to eliminate microbial dental plaque that is the primary etiology of periodontal diseases.
15918658|NCT03507855|Other|Reduced noise|All activity will cease when the patient enters the operating room and nonessential personnel will be removed. Ambient lighting will be reduced and communication devices muted.
15918659|NCT03507855|Other|Normal|No change in the normal operating room environment.
15918660|NCT03507842|Drug|High dose Cytarabine|High dose Cytarabine 3.0 g/m2 q12hr 3-hour iv infusion on days 1, 3, 5 plus daunorubicin 45 mg/m2/day continuous iv infusion for 3 days (D1-3).
15918661|NCT03507842|Drug|Cytarabine|cytarabine 200 mg/m2/day continuous iv infusion for 7 days (D1-7)
15918662|NCT03507842|Drug|Hign dose Daunorubicin|Hign dose Daunorubicin 90 mg/m2/day continuous iv infusion for 3 days (D1-3).
15918663|NCT03507829|Drug|Human insulin isophane, Humulin N (Eli Lilly)|Human insulin isophane, Humulin N (Eli Lilly)
15918664|NCT03507829|Drug|Standard of care|Sliding scale short acting insulin for hyperglycemia; Sulphonylurea for NODAT
15918665|NCT03507829|Drug|Insulin lispro, Humalog (Eli Lilly) in insulin pump|Insulin lispro, Humalog (Eli Lilly) in insulin pump
15918666|NCT03507803|Other|Gait Biofeedback|Feedback will appear on screen in front of participants during walking. If their foot is too inverted (determined by researcher) the object on the screen will turn red and an audio tone will be heard. If the participant corrects the foot position, the object will turn green and the audio tone will not be heard.
15918667|NCT03507790|Drug|CT1812|Active Study Drug
15918668|NCT03507790|Drug|Placebo|Non-active study drug
15918669|NCT03507777|Device|Coronary PCI guided by OCT|Stent implantation in high-risk or complex lesions in patients with coronary artery disease using OCT guidance
15918670|NCT03507777|Device|Coronary PCI guided by Angiography|Stent implantation in high-risk or complex lesions in patients with coronary artery disease using angiography guidance
15918671|NCT03507764|Other|Use of the treadmill workstation at work|"During the randomized study phase, provision of the treadmill workstation with the recommendation to use it for at least one hour (continuous or split) during each of the working shifts.
~After six months, all subjects will use treadmill without restrictions or conditions."
15918672|NCT03507751|Drug|Meropenem|1.0 gram of meropenem given intravenously every 8 hours
15918673|NCT03507751|Procedure|CRRT|Continuous renal replacement therapy for three days
15918674|NCT03507738|Biological|MT-5625 low dose|Intramuscular injection
15918675|NCT03507738|Biological|MT-5625 middle dose|Intramuscular injection
15918676|NCT03507738|Biological|MT-5625 high dose|Intramuscular injection
15918677|NCT03507738|Biological|Rotarix|Oral administration
15918678|NCT03507738|Biological|Placebo|Intramuscular injection
15918713|NCT03507439|Device|VitalPatch Biosensor|Patients will receive the VitalPatch Biosensor system at 5 monitoring periods
15918714|NCT03507439|Device|DynaPort Move Monitor|Patients will receive the DynaPort Move Monitor (belt) at 2 monitoring periods
15948034|NCT03279237|Drug|Oxaliplatin|May help shrink tumor before surgery.
15918679|NCT03507725|Behavioral|Meditation|"The brief mind-body intervention, specifically developed for this study, is a combination of mindfulness meditation with a specific cognitive component of guided imagery. Patient intervention, they will be given headphones connected to an MP4 player in the clinic area to listen to a pre-biopsy mindfulness exercise (10 minutes). They will then be brought into the biopsy procedure room and given a second set of headphones, guiding the patient through the mindfulness intervention during the biopsy procedure (10 minutes)."
15918680|NCT03507725|Procedure|Prostate Biopsy|Prostate needle biopsy under local anesthesia
15918681|NCT03507725|Behavioral|Questionnaires|Questionnaires completion will be by telephone interview or manual completion of paper or online REDCap instruments, depending on participant preference.
15918682|NCT03507712|Procedure|Symmetrical IO weakening|Bilateral IO Myectomy / Bilateral equal graded IO Recession
15918683|NCT03507712|Procedure|Asymmetrical IO weakening|IO Myectomy in one eye - IO Recession in the fellow eye / Bilateral IO Recession (different amounts) in each eye
15918684|NCT03507699|Radiation|Liver radiation therapy|21 Gy in three fractions to one liver metastasis
15918685|NCT03507699|Drug|Nivolumab Injection [Opdivo]|administered IV at a dose of 3mg/kg every 2 weeks
15918686|NCT03507699|Drug|Ipilimumab Injection [Yervoy]|administered IV at a dose of 1mg/kg every 6 weeks
15918687|NCT03507699|Drug|CMP-001|A TLR9 agonist, will be administered both into the liver metastasis (three times), and also injected subcutaneously at a dose of 5-10 mg every two weeks.
15918688|NCT03507686|Drug|BIIB111|Administered as specified in the treatment arm.
15918689|NCT03507673|Diagnostic Test|Blood samples and microbiological swaps|Blood analysis and analysis of vaginal microbiota.
15918690|NCT03507660|Other|verbal instruction|Verbal instruction for pelvic floor contraction will be given to participants. Ultrasound examination will be conducted to asses urinary bladder displacement being a marker for pelvic floor muscle function.
15918693|NCT03507634|Drug|Opioid free Anesthesia dexmedetomidine and lidocaine|Opioid free anesthesia with dexmedetomidine and lidocaine
15918694|NCT03507634|Drug|Opioid based anesthesia Fentanyl and Remifentanyl|Opioid based anesthesia with Fentanyl and Remifentanyl
15918695|NCT03507608|Drug|Flutamide|50mg flutamide prior to brachytherapy and prostatic biopsy
15918696|NCT03507608|Other|Placebo|placebo prior to brachytherapy and prostatic biopsy
15918697|NCT03507582|Other|Virtual Reality Distraction|This intervention consists of a disposable virtual reality headset which will enable the use of virtual reality in clinic through the commodity hardware iPod Touch. An additional piece of software on an iPad will allow clinical staff to act as an orchestrator and trigger events that occur for the patient's benefit in the virtual reality environment. The mechanism for the dashboard will be dashboard software running on an iPad tablet that will wirelessly communicate to the iPod Touch the patient is wearing. A study timer will be incorporated into the orchestration dashboard. The VAS/FACES scale will be incorporated into the iPad used for orchestration.
15918698|NCT03507582|Other|Standard of Care Distraction|This intervention consists of a two dimensional distraction (ie TV/tablet) as well as verbal distraction (ie singing/talking/music) will be allowed by caregivers, nurses and phlebotomy staff but will not qualified or quantified. IV procedures will proceed in Groups A and B. At the completion of the IV procedure the nurse orchestrator will stop the procedure timer. The Subject, Guardian and Nurse orchestrator will complete the Final VAS/FACES assessment on the iPad.
15918699|NCT03507569|Drug|RO7017773|RO7017773 will be administered orally. The doses to be tested will be determined by review of PET scan, PK, and safety results from the previous dose level.
15918700|NCT03507569|Other|[11C] Ro15-4513|At the start of each PET scan, participants will receive an intravenous dose of the radiolabeled tracer [11C]Ro15-4513.
15918701|NCT03507556|Procedure|Triple paste and induced bleeding|
15918702|NCT03507556|Drug|Triple Paste metronidazole, ciprofloxacin and minocycline mixed with sterile glycol|triple paste of metronidazole, ciprofloxacin and minocycline mixed with sterile glycol
15918703|NCT03507543|Drug|IMP4297|The dose levels will be escalated following a modified 3+3 dose escalation scheme.
15918704|NCT03507530|Other|Assessments|Falls related assessments, functional physical performance evaluations and quality of life assessments.
15918705|NCT03507504|Other|SCU-B|"SCU-B is a residential medical structure lying outside of a nursing home, in a general hospital or elsewhere, e.g. in a private hospital, where patients with BPSD are temporarily admitted when their behavioural disturbances are not amenable to control at home."
15918706|NCT03507491|Drug|Gemcitabine|Gemcitabine will be administered intravenously once weekly over 60 minutes every 3 out of four weeks. The dose of gemcitabine will start at 675 mg/m2/dose. If the MTD has been exceeded at the Dose Level 1, then the subsequent cohort of participants will be treated with gemcitabine at a dose of 500 mg/m2/dose (Dose Level 0).
15918707|NCT03507491|Drug|Nab-paclitaxel|Nab-Paclitaxel will be administered intravenously over 30 minutes once weekly every 3 out of 4 weeks. Nab-paclitaxel will be administered prior to administration of gemcitabine. The starting dose of nab-paclitaxel will be 180 mg/m2/dose (dose level 1). Dose levels for subsequent groups of subjects are 210 mg/m2/dose (for dose level 2) and 240 mg/m2/dose (for dose level 3).
15918708|NCT03507478|Device|BPI1000013|Foam insole
15918709|NCT03507465|Drug|Letrozole Plus Low-Dose Metronomic Capecitabine|Letrozole Plus Low-Dose Metronomic Capecitabine
15918715|NCT03507426|Procedure|Retrobulbar block|Patients will receive a single retrobulbar injection with 3-4ml of an equal mixture of Lidocaine 2% & Bupivacaine 0.5% + Hyaluronidase (10 IU/ml), after induction of general anesthesia.
15918716|NCT03507426|Procedure|Ketamine|Patients will receive a 0.5 mg/kg bolus followed by an infusion of 0.25 mg/kg/h of intravenous Ketamine, after induction of general anesthesia.
15918717|NCT03507413|Drug|Metformin Glucophage 500mg (IR) tablets M90|oral metformin Glucophage treatment 500 mg daily (2-0-2) for 1 year
15918718|NCT03507413|Drug|Placebo Oral Tablet|Placebo Oral Tablet M90 treatment twice daily (2-0-2) for 1 year
15918719|NCT03507400|Behavioral|Introvision: mental and emotional self-regulation|Participants learn Introvision
15918720|NCT03507387|Drug|Phenylephrine|5 mg (1ml) phenylephrine intramuscular injection will be given into the gluteus maximus muscle before anesthesia.100ug (1ml) phenylephrine intravenous injection will be given after the subarachnoid injection is completed .
15918721|NCT03507387|Drug|Normal saline|1ml 0.9% normal saline intramuscular injection will be given into the gluteus maximus muscle before anesthesia and after the subarachnoid injection is completed.
15918722|NCT03507387|Drug|Bupivacaine|All patients will receive spinal anesthesia with bupivacaine.
15918723|NCT03507374|Drug|Alirocumab|Alirocumab is approved by the FDA as a secondary treatment for high cholesterol for adults whose cholesterol can not be controlled by diet and/or statin treatment. Additionally, Alirocumab works to inhibit the PCSK9 protein.
15918724|NCT03507374|Drug|Placebo|Placebo to be administered subcutaneously every 2 weeks identical to active drug (alirocumab)
15918725|NCT03507361|Other|HRV-BASED MUSIC|Music is produced by Sound-of-Soul technology that translates HRV power frequency spectrum real-time into music. The intervals between the heartbeats are detected in milliseconds and then transferred into a frequency spectrum. Sound of Soul system gets wired into different band pass filters which are linked to the frequencies of the heart (i.e. low frequency and high frequency). Once the signal is detected and computed, the Sound of Soul system links it through a musical instrument digital interface (MIDI). This interface transforms ECG data into music and sounds. The audio production is performed using a virtual instrumentation technology with different music libraries. For the puropose of this study, all patients will ear the same instrument (arp). Once the instrument have been selected, the ECG gets recorded and in real-time the patient can hear a music obtained from his/her own HRV. The investigator will control the volume and the different settings of the music.
15918726|NCT03507348|Drug|visits of tocilizumab injection (every 4 weeks, up to 5 visits)|every 4 weeks, up to 5 visits (D-170, D-142, D-114, D-86, D-58).
15918727|NCT03507348|Drug|Rituximab 375 mg/m2 at Day-30|Rituximab 375 mg/m2 at Day-30
15918728|NCT03507348|Drug|Rituximab 375 mg/m2 at Day-15 (only for donors living)|Rituximab 375 mg/m2 at Day-15
15918729|NCT03507348|Other|Transplant Day-0|TRANSPLANTATION
15918730|NCT03507335|Device|chest strap and PPG-device for monitoring the rhythm|chest strap and PPG-device for monitoring the rhythm during 24 hours for both groups (atrial fibrillation and sinus)
15918731|NCT03507322|Other|Ultrasound texturization|Along several visits to the clinic, the patients will be subjected to 2D/3D ultrasound scanning.
15918732|NCT03507283|Procedure|Double head pterygia excision and repair|Complete excision of the pterygia was done. A free conjunctival autograft was obtained. The graft was divided vertically into two parts then secured into conjunctival defects.
15918733|NCT03507270|Diagnostic Test|FABP|Assessment of changes in FABP concentrations
15918734|NCT03507257|Drug|Flortaucipir|All participants will receive a single bolus intravenous injection of approximately 10 mCi (+/- 10%, 20μg mass dose) of flortaucipir (18F-AV-1451). At approximately 75-minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.
15918735|NCT03507257|Drug|Florbetaben|All participants will receive a single bolus intravenous injection of approximately 8 mCi +/- .8mCi of florbetaben (AV-45). At approximately 90-minutes (+/- 10 minutes) post dose, scanning will begin. An approximately 20-minute image acquisition scan will be performed.
15918736|NCT03507257|Drug|Fluorodeoxyglucose|All participants will receive a single bolus intravenous injection of approximately 5 mCi (+/- 10%, 0.5 mCi) of fluorodeoxyglucose. At approximately 30 minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.
15918737|NCT03507244|Drug|Pemetrexed|Pemetrexed, 10 mg,intrathecal injection, plus dexamethasone 5 mg, once per week, 5 to 8 times, 4 to 7 weeks in total.
15918738|NCT03507244|Drug|Dexamethasone|Dexamethasone, 5 mg, intrathecal injection, simultaneously with pemetrexed, once per week, 5 to 8 times, 4 to 7 weeks in total.
15918739|NCT03507244|Radiation|Radiotherapy|The sites of symptomatic disease, bulky disease observed on MRI, including the whole brain and basis cranii, 40 Gy in 20 fractions;and/or segment of spinal canal received 40-50 Gy in 20-25 fractions.
15918740|NCT03507231|Behavioral|Email Message|Participants will randomly receive an e-mail message about the availability of free flu vaccines.
15918741|NCT03507231|Behavioral|Incentive for Vaccination|$5 gift card offered for vaccination
15918742|NCT03507231|Behavioral|Incentive for completing a short survey|$5 gift card offered for completing s short survey after one gets vaccinated
15918743|NCT03507205|Device|Biomatrix; Biomatrix Flex; Nobori|Biodegradable polymer-coated biolimus-eluting stents
15918744|NCT03507205|Device|Xience Prime|Durable polymer-coated everolimus-eluting stents
15918745|NCT03507205|Device|Xience V/Promus; Cypher|Durable polymer-coated everolimus-eluting stents; Sirolimus-eluting stents
15918746|NCT03507205|Device|DP-ZES-RI|Durable polymer-coated zotarolimus-eluting stents
15918747|NCT03507205|Device|Endeavor; Resolute|Durable polymer-coated zotarolimus-eluting stents
15918748|NCT03507192|Device|Muscle relaxation using full body massage machine|Receiving muscle relaxation machine massage every morning and evening for 30 minutes during a year
15918749|NCT03507179|Other|3d printed denture|construction of a 3d printed denture through a recent method instead of conventional processing
15918750|NCT03507179|Other|conventional dentures|conventional dentures
15918751|NCT03507166|Drug|RC48-ADC|2 mg/kg IV every 2 weeks
15918752|NCT03507153|Procedure|Bre-flex maxillary partial denture|Partial denture fabricated from Bre.flex material.
15918753|NCT03507153|Procedure|PEEK maxillary partial denture|Partial denture fabricated from PEEK material.
15918865|NCT03506373|Other|Pharmacokinetic Study|Correlative studies
15918754|NCT03507140|Other|Multiple sampling|"Bile, saliva, feces, urine et blood samples before and after liver transplantation in recipients.
~Bile, saliva, feces, urine et blood samples during liver removal in donors."
15918755|NCT03507127|Drug|Varenicline|Standard dosing: 0.5 mg/day on days 1-3, 0.5 mg twice daily (morning, evening) on days 4-7, then 1 mg twice daily to the end of the medication period.
15918756|NCT03507127|Drug|Placebo|Dosing schedule matched to active comparator: on tablet on days 1-3, one tablet twice daily (morning, evening) on days 4-7, then one tablet twice daily to the end of the medication period.
15918757|NCT03507114|Behavioral|Rumination-Focused CBT (RFCBT)|RFCBT consists of six online modules that include psycho-education, mood diaries, on-line experiential exercises using audio-recordings & vignettes of participants experiences of the therapy.
15918759|NCT03507088|Drug|Fluoroestradiol (18F)|A FES-PET/(CT) will be performed twice during protocol execution. Patients will be injected with approximately 222 MBq 18F-FES each time.
15918760|NCT03507075|Behavioral|Contingency management: Contingent incentives|Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions and verified abstinence from alcohol.
15918761|NCT03507075|Behavioral|Contingency management: Noncontingent incentives|Monetary incentives are delivered to participants contingent upon on-time breathalyzer submissions only with no contingency on alcohol use.
15918762|NCT03507062|Other|0.9% saline administration|Each patient will receive 0.9%saline based on attending physician decision
15918763|NCT03507062|Other|Ringer's lactate administration|Each patient will receive Ringer's lactate based on attending physician decision
15918764|NCT03507062|Other|Plasmalyte-like solution administration|Each patient will receive Plasmalyte-like solution based on attending physician decision
15918765|NCT03507049|Procedure|iFuse|ifuse will be implanted as described in section on the active comparator arm of the study.
15918766|NCT03507049|Procedure|sham group|sham surgery will be performed as desrcribed in section on sham comparator.
15918767|NCT03507049|Radiation|fMRI study|Quantitative sensory testing, cerebral MRI and functional MRI will be done to examine pain mechanism and activation in the central nervous system.
15918768|NCT03507036|Device|Profound system|Profound system is a bipolar fractional radiofrequency device which uses microneedles and thermal heat to stimulate neocollagenesis. Based on the its effect on facial skin, it can be hypothesized that bipolar fractional radiofrequency will stimulate similar effect on suprapatellar skin, lifting and reducing laxity of the skin in that region. Bilateral suprapatellar regions will be identified and marked for treatment.
15918769|NCT03507023|Dietary Supplement|Metabolaid®|500 mg per day, in fasting conditions.
15918770|NCT03507023|Dietary Supplement|Placebo|500 mg per day, in fasting conditions.
15918771|NCT03507010|Radiation|Radiotherapy|Patients randomized to the Radiotherapy arm will be treated with electrons and receive a total dose of 30 Gy (two separate courses of five daily fractions of 3.0 Gy each).
15918772|NCT03507010|Other|Sham Radiotherapy|Patients randomized to the sham-radiotherapy will not be treated and the radiotherapy treatment will only be simulated.
15918773|NCT03506997|Drug|Pembrolizumab|Pembrolizumab 200mg given as a 30 minute intravenous (IV) infusion, on day 1 of each 3 week cycle. Patients may continue with pembrolizumab treatment as long as they remain free from intolerable toxicity for a maximum of two years, if in the Investigator's opinion they are receiving clinical benefit, and/or they do not meet any discontinuation criteria.
15918774|NCT03506984|Device|Threshold Inspiration Muscle Training Device|Threshold based trainer is a small handled device.It includes a mouthpiece and a calibrated spring loaded valve. The valve control a constant inspiratory pressure training load and the patient must generate a suffient inspiratory pressure in order for the inspiratory valve to be opened and allow the air to be inhaled. The amount of resistance can be adjusted by varying the compression of the spring-loaded valve. Adjustment from 9cmH2o to 41cmH2o.
15918775|NCT03506984|Device|Electronic Bicycle Ergometer|Electronic Bicycle equipped with electronic break, display screen, adjustable seat, handle bar and foot straps will be used in High interval intensity training.
15918779|NCT03506958|Procedure|Standard trauma care|In both groups, all procedures and management will be done according to the hospital's standard of care.
15918780|NCT03506945|Behavioral|mPEP|Behavioral Activation Therapy
15918781|NCT03506945|Behavioral|Bibliotherapy|Provide educational material on coping strategies pertinent to caregivers
15918782|NCT03506932|Dietary Supplement|Untreated|Bread made with 20% yellow pea flour that was untreated.
15918783|NCT03506932|Dietary Supplement|Heat treated with 0% moisture|Bread made with 20% yellow pea flour that was heat treated with 0% moisture.
15918784|NCT03506932|Dietary Supplement|Heat treated with 10% moisture|Bread made with 20% yellow pea flour that was heat treated with 10% moisture.
15918785|NCT03506932|Dietary Supplement|Wheat|Bread made with 100% wheat
15918786|NCT03506919|Drug|Allopurinol|Allopurinol is used to treat gout and certain types of kidney stones. It is also used to prevent increased uric acid levels in patients receiving cancer chemotherapy. These patients can have increased uric acid levels due to release of uric acid from the dying cancer cells. Allopurinol works by reducing the amount of uric acid made by the body. Increased uric acid levels can cause gout and kidney problems
15918787|NCT03506906|Diagnostic Test|Sleep studies under noninvasive ventilation therapy|Polysomnography Transcutaneous capnography
15918788|NCT03506906|Diagnostic Test|Routine tests|Spirometry, six minute walk test, blood gas analysis, questionnaires (Epworth sleepiness score, health related quality of life severe respiratory insufficiency questionnaire)
15918789|NCT03506893|Device|Alphapump|"Alfapump® device: a completely internalized medical device, implanted under the skin, which mobilizes ascites from the peritoneal cavity to the bladder where they are eliminated by the urinary tract.
~Medical device marked CE, used in the indication provided for marking"
15918790|NCT03506893|Procedure|Ascites puncture|Hospitalizations for evacuating ascites are performed at least twice a month and can be up to 2 times a week. A clinical and biological examination is carried out at each visit.
15918791|NCT03506880|Behavioral|MADD Materials|
15918792|NCT03506880|Behavioral|Surgeon General Materials|
15918793|NCT03506867|Behavioral|Life skills, training, education and work/volunteer opportunities|Intervention arm will receive proactive and sustained access to enhanced education and socio-economic supports (e.g. volunteer and/or work opportunities).
15918794|NCT03506867|Behavioral|Standard Care|Usual care will receive information on locally available services.
15918795|NCT03506854|Drug|ISIS 681257|Xmg dose administered as a subcutaneous injection
15918796|NCT03506841|Drug|Cerebrolysin|Cerebrolysin injections of 0.1 mL/kg body weight for 3 months (total of twelve injections).
15918797|NCT03506828|Procedure|Surgical sympathectomy|thoracoscopic sympathectomy
15918798|NCT03506828|Procedure|Radiofrequency ablation with phenol injection|All patient in this group will have radiofrequency ablation of T2 and T3 sympathetic ganglia with phenol injection
15918799|NCT03506815|Drug|Rivaroxaban 10 MG|Rivaroxaban 10mg po daily x 90 (+/- 3 days)
15918800|NCT03506802|Radiation|18F-FHBG|Given IV
15918801|NCT03506802|Biological|Aldesleukin|Given SC
15918802|NCT03506802|Biological|Cellular Therapy|LV-NYESO TCR /sr39TK PBSC and RV-NYESO TCR PBMC given IV
15918803|NCT03506802|Procedure|Computed Tomography|Undergo PET/CT
15918804|NCT03506802|Biological|Filgrastim|Given SC
15918805|NCT03506802|Other|Laboratory Biomarker Analysis|Correlative studies
15918806|NCT03506802|Drug|Lenalidomide|Given PO
15918807|NCT03506802|Procedure|Leukapheresis|Undergo leukapheresis
15918808|NCT03506802|Drug|Melphalan|Given IV
15918809|NCT03506802|Drug|Plerixafor|Given SC
15918810|NCT03506802|Procedure|Positron Emission Tomography|Undergo PET/CT
15918811|NCT03506789|Drug|Dexamethasone|Dexamethasone 24 mg
15918812|NCT03506789|Drug|Placebos|Isotonic saline
15918813|NCT03506776|Device|Education and Thermometer Group|The education will be provided in video format utilizing the Canadian Association of Wound Care (CAWC) diabetic foot management YouTube video and one-on-one teaching. Participants will be provided with an inspection mirror with an extendable handle to assist with visualizing the bottom of the feet and a pedometer to measure daily activity. One-on-one teaching with the thermometer will be provided. Participants will be given a handout for reference on using the thermometer. The foot model will be marked with a zigzag pattern on the plantar surface to illustrate the path that should be used when measuring temperature. The support person will be included in the teaching if he/she will be assisting the participant to obtain temperature readings.
15918814|NCT03506776|Other|Education Only Group|The education will be provided in video format utilizing the Canadian Association of Wound Care (CAWC) diabetic foot management YouTube video and one-on-one teaching. Participants will be provided with an inspection mirror with an extendable handle to assist with visualizing the bottom of the feet and a pedometer to measure daily activity.
15918815|NCT03506763|Drug|Placebo Oral + Placebo Oral|Placebo Oral + Placebo Oral
15918816|NCT03506763|Drug|Diclofenac oral + Placebo Oral|Diclofenac oral + Placebo Oral
15918817|NCT03506763|Drug|Diclofenac oral + scopolamina oral|Diclofenac oral + scopolamina oral
15918818|NCT03506750|Drug|IVC|Patients with PDR will receive intravitreal injection of conbercept (0.5 mg/0.05 mL; Chengdu Kanghong Biotech, Inc., Chengdu, Sichuan, China) in the inferior-temporal sector 4 mm from the sclerocorneal limbus before pars plana vitrectomy (PPV) surgery.
15918819|NCT03506750|Procedure|Blood and aqueous humor at the time of IVC|Initial blood and aqueous humor will be harvested at the time of IVC.
15918820|NCT03506750|Procedure|Collect blood, aqueous humor, and initial vitreous at the time of surgery.|Blood, aqueous humor, and vitreous will be collected at the time of surgery.
15918821|NCT03506750|Procedure|IVC-sham|Patients with PDR will receive sham intravitreal injection of conbercept in the inferior-temporal sector 4 mm from the sclerocorneal limbus 4 days before PPV surgery.
15918822|NCT03506737|Other|Conventional exercise protocol|Breathing exercises and global active exercises of the upper and lower limbs while in the upright seated position
15918823|NCT03506737|Other|Cycle ergometer exercise protocol|Stationary cycle ergometer exercise while in the upright seated position for 20 minutes. The protocol will be performed intermittently with 5 periods; each period consists of 3 minutes of cycling followed by 1-minute of rest.
15918824|NCT03506724|Drug|Nifedipine|Nifedipine 10mg oral will be given and the MAP will then be calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral will be given and the MAP will then be calculated 20 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, nifedipine 20mg oral will be given and the MAP will then be calculated 20 minutes after medication is given and institution specific protocol will be performed.
15918825|NCT03506724|Drug|Labetalol|Labetalol 20mg IV will be given over 2 minutes and the MAP will then be calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 40mg IV will be given over 2 minutes and the MAP will then be calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, labetalol 80mg IV will be given over 2 minutes and the MAP will then be calculated 10 minutes after medication is given. If SBP is ≥160mmHg or DBP is ≥110mmHg, then another medication will be chosen based on institution specific protocol.
15918826|NCT03506711|Diagnostic Test|Isometric Handgrip Exercise during magnetic resonance imaging|Coronary endothelial function are assessed by MRI with imaging studies done at baseline (at rest) and during IHE (under stress). Maximum grip strength is determined using an MRI-compatible dynamometer (Grip Force Fiber Optic Response Pad, Current Designs Inc., Philadelphia, USA) prior to baseline imaging.
15918866|NCT03506360|Drug|Dexamethasone|Given PO
15918867|NCT03506360|Drug|Ixazomib Citrate|Given PO
15918827|NCT03506698|Other|Kangaroo Mother Care (KMC)|Skin to skin contact of newborns with mothers or caregiver for a minimum of at least eight hours over a 24-hours period, along with exclusive breastfeeding or breast milk feeding via tube or spoon
15918828|NCT03506685|Other|Dry needling and STM|dry needling and soft tissue mobilization
15918829|NCT03506672|Other|Approach based on the meanings of vocal behaviours|Systematic problem-solving approach involving reflecting, deciding, planning and acting together (family and formal caregivers to reduce vocal behaviours and to increase everyone's well-being.
15918830|NCT03506672|Other|Usual practices|Usual practices of formal caregivers regarding vocal behaviours
15918831|NCT03506659|Device|SUDO-SCAN Device|Sudo-scan is a machine with 2 palets for hands and 2 palets for foots. The patient has to put his 2 hands and 2 foots on the machine. The machine do the measures during 2 minutes.
15918832|NCT03506646|Dietary Supplement|Beetroot juice|Beetroot juice serves as a mode of dietary nitrate supplementation. This will be a double-blinded, randomized, cross-over design to examine the effects of beetroot juice on endothelial function, leg function, and thermoregulation.
15918833|NCT03506633|Dietary Supplement|MitoQ|"A mitochondrial-targeting antioxidant MitoQ or a placebo will be given to each subject in a crossover, double-blinded design and measures of leg function and leg blood flow will be measured."
15918834|NCT03506620|Drug|Ropivacaine injection|Naropin (Ropivacaine HCl) 0.25%; Dose: 20 cc
15918835|NCT03506620|Drug|Saline Solution for Injection|20 cc of saline will be injected in the form of a QL block as a placebo.
15918836|NCT03506607|Other|Exercise in hypoxia 1500m|Subjects will perform a 6-min treadmill exercise wearing an oronasal mask connected (through a hose) with a three-way valve to an altitude simulation device (Altitrainer; SMTech, Nyon, Switzerland). The ambient air will be mixed with nitrogen and inspired oxygen fraction will be reduced to 16%. The first 3 min will be performed at 70% of the mean speed calculated during a previous visit, and the last 3 min at an intensity between 12-14 on the Borg's scale.
15918837|NCT03506607|Other|Exercise in hypoxia 2500m|Subjects will perform a 6-min treadmill exercise wearing an oronasal mask connected (through a hose) with a three-way valve to an altitude simulation device (Altitrainer; SMTech, Nyon, Switzerland). The ambient air will be mixed with nitrogen and inspired oxygen fraction will be reduced to 14%. The first 3 min will be performed at 70% of the mean speed calculated during a previous visit, and the last 3 min at an intensity between 12-14 on the Borg's scale.
15918838|NCT03506607|Other|Exercise in normoxia|Subjects will perform a 6-min treadmill exercise wearing an oronasal mask connected (through a hose) with a three-way valve to an altitude simulation device (Altitrainer; SMTech, Nyon, Switzerland). For the exercise performed in normoxia conditions, subjects will breathe room air. The first 3 min will be performed at 70% of the mean speed calculated during a previous visit, and the last 3 min at an intensity between 12-14 on the Borg's scale.
15918839|NCT03506594|Device|Radiofrequency non ablative|The application of RF was performed by physical therapist trained in the technique of radiofrequency through the Capenergy® brand device with capacitive transfer method using non-ablative handle with active electrode placed intra-vaginal and coupling electrode placed on the participant's back. For application, the participants were in gynecological position. The session had an average duration above 20 minutes. The temperature was measured by an infrared thermometer and when it reached 41graus radiofrequency was maintained for 2 minutes in the anterior wall and 2 other minutes in the posterior wall of the vagina.
15918840|NCT03506568|Device|Devers Drop Device (D3) app|A universal eye drop cap monitor that accurately measures and improves eye drop-taking behavior.
15918841|NCT03506555|Procedure|Laparoscopic peritoneal entry technique: Veress needle versus Hasson|According to randomization, the closed (Veress needle) or the open (Hasson) laparoscopic entry technique was utilized for general surgical operations
15918842|NCT03506542|Device|Ologen|Ologen implant placed over scleral flap during the surgery to avoid usage of Mitomycin C
15918843|NCT03506542|Procedure|Phacotrabeculectomy|Trabeculectomy with cataract extraction
15918844|NCT03506542|Drug|Mitomycin C|Mitomycin C 0.3 mg/ml for 3 minutes during the surgery (standard procedure)
15918845|NCT03506529|Other|questionnary|questionnary on predictif factors about physiological hypermetabolism of anal canal
15918846|NCT03506516|Dietary Supplement|Mixing alcohol|Alcoholic beverages, different types
15918847|NCT03506516|Dietary Supplement|Single type alcohol|Alcoholic beverages, different types
15918848|NCT03506503|Procedure|Nanofat grafting|hair loss area will be treated by processed autologous Nanofat grafting
15918849|NCT03506490|Other|Aerobic exercises|The training session lasted 45 minutes and was composed of running exercises.
15918850|NCT03506477|Drug|Enstilar® foam|for 4 weeks
15918851|NCT03506477|Drug|Vehicle foam|for 4 weeks
15918852|NCT03506464|Procedure|Myofascial Release Technique|The same described in the arm description
15918853|NCT03506451|Other|Demographics questionnaires and the FACT HN questionnaire|Patients will complete a baseline survey assessing socioeconomic household information, baseline symptoms, QOL, and financial toxicity, as well as attitudes toward cost conversations and educational handouts.
15918854|NCT03506438|Behavioral|Needs-focused mobile app|A mobile web app designed to assist both ICU clinicians in addressing patient/family needs and families in reporting their unmet needs.
15918855|NCT03506438|Other|Usual care|Usual ICU care
15918856|NCT03506425|Drug|Triheptanoin|Triheptanoin is a medium chain triglyceride (MCT) that can improve mitochondrial function and energy production and therefore has potential for slowing ALS progression. Indeed, triheptanoin slowed motor neuron loss and delayed the onset of weakness in a mutant SOD1 model of ALS. The Triheptanoin we will use is a colorless to light yellow oil. The target triheptanoin dose for this study is 1g/kg/d. This target dose was selected because it was safe and tolerable and altered brain MR spectroscopy in patients with Huntington's Disease.
15918857|NCT03506412|Drug|Entresto™ 49Mg-51 mg tablet|Entresto™ 49Mg-51 mg will be given twice daily orally for 5 weeks
15918858|NCT03506399|Drug|Lanabecestat|Administered orally
15918859|NCT03506399|Drug|Oral Contraceptive|Administered orally
15918860|NCT03506386|Other|No Intervention|As it was an observational study, no intervention was administered.
15918861|NCT03506373|Drug|Ibrutinib|Given PO
15918862|NCT03506373|Drug|Ixazomib Citrate|Given PO
15918863|NCT03506373|Other|Laboratory Biomarker Analysis|Correlative studies
15918864|NCT03506373|Other|Pharmacodynamic Study|Correlative studies
15918871|NCT03506334|Device|AVBT using Dynesys System Components|Zimmer Biomet Tether System and Dynesys System components are intended to treat scoliosis in skeletally immature children.
15918872|NCT03506334|Procedure|Spine fusion|Children with scoliosis undergoing fusion surgery will form the control arm
15918873|NCT03506321|Diagnostic Test|chromoendoscopy, high definition white light and narrow band imaging|Chromoendoscopy, high definition white light and narrow band imaging are compared for predicting submucosal invasion within laterally spreading lesions in the colon and determining the presence of residual or recurrent adenoma at the post endoscopic resection scar
15918874|NCT03506308|Device|LUTONIX 035 Drug Coated Balloon PTA Catheter|All subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.
15918875|NCT03506295|Device|Radial Endobronchial Ultrasound Probe|The radial EBUS procedure is performed by inserting a miniature ultrasound probe (radial EBUS probe) through the working channel of a flexible bronchoscope or catheter (guide sheath). Real-time imaging of the surrounding tissue enables the clinician to determine the lesion's exact location and size.
15918876|NCT03506295|Device|Flouroscopy|Real-time fluoroscopy will be used in all cases to guide the radial probe ultrasound and/or cryobiopsy probe placement.
15918877|NCT03506282|Other|Running while listening to a traffic audio track|While running three 2-minute sets at different velocities (6, 8 and 10 km/h, respectively) on a sensorized treadmill, each participant will be exposed via earphones to an audio track resembling average outdoor conditions (70 dB).
15918878|NCT03506282|Other|Running with music at moderate volume|"While running three 2-minute sets at different velocities (6, 8 and 10 km/h, respectively) on a sensorized treadmill, each participant will be provided the same music track (We take care of our own, by Bruce Springsteen from the Wrecking Ball album, 2012). The music track will be given at a moderate volume (80 dB)."
15918879|NCT03506282|Other|Running with music at moderate-to-high volume|"While running three 2-minute sets at different velocities (6, 8 and 10 km/h, respectively) on a sensorized treadmill, each participant will be provided the same music track (We take care of our own, by Bruce Springsteen from the Wrecking Ball album, 2012). The music track will be given at a moderate-to-high volume (85 dB)."
15918880|NCT03506256|Drug|Norfloxacin 400 MG|Norfloxacin is an oral fluoroquinolone antimicrobial agent used for the treatment of uncomplicated and complicated urinary tract infections. The drug antagonizes DNA gyrase, an enzyme essential for bacterial DNA replication and is active in vitro against virtually all bacterial pathogens causing urinary tract8
15918881|NCT03506243|Biological|Follitrope PFS|Follitrope PFS
15918882|NCT03506243|Biological|Gonal-f pen|Gonal-f pen
15918883|NCT03506230|Behavioral|Incentives|A bonus to buy their medications if they reduce their HBA1c
15918884|NCT03506217|Device|Vigileo Flo-trac device|A Vigileo Flotrac pulse counter invasive arterial cardiac output meter was used for cardiac output measurement. Heart rate, blood pressure, cardiac output, stroke volume variance (SVV), systemic vascular resistance (SVR) values were recorded.
15918885|NCT03506178|Drug|Oxymetazoline Nasal Spray|Obstructive sleep apnea (OSA) Patients and healthy controls were treated with 4 different nasal intervention ,including Oxymetazoline Nasal Spray,Normal saline Nasal Spray,Menthol Nasal Spray or Nasal mask with partly blocked when they sleep onset. At the treatment periods, polysomnograpy, genioglossus enlectromyography, pharyngeal current perception threshold and sleep quality scores were assess.
15918886|NCT03506178|Drug|Menthol Nasal Spray|Obstructive sleep apnea (OSA) Patients and healthy controls were treated with 4 different nasal intervention ,including Oxymetazoline Nasal Spray,Normal saline Nasal Spray,Menthol Nasal Spray or Nasal mask with partly blocked when they sleep onset. At the treatment periods, polysomnograpy, genioglossus enlectromyography, pharyngeal current perception threshold and sleep quality scores were assess.
15918887|NCT03506178|Drug|Normal saline Nasal Spray|Obstructive sleep apnea (OSA) Patients and healthy controls were treated with 4 different nasal intervention ,including Oxymetazoline Nasal Spray,Normal saline Nasal Spray,Menthol Nasal Spray or Nasal mask with partly blocked when they sleep onset. At the treatment periods, polysomnograpy, genioglossus enlectromyography, pharyngeal current perception threshold and sleep quality scores were assess.
15918888|NCT03506178|Device|Nasal mask with partly blocked|Obstructive sleep apnea (OSA) Patients and healthy controls were treated with 4 different nasal intervention ,including Oxymetazoline Nasal Spray,Normal saline Nasal Spray,Menthol Nasal Spray or Nasal mask with partly blocked when they sleep onset. At the treatment periods, polysomnograpy, genioglossus enlectromyography, pharyngeal current perception threshold and sleep quality scores were assess.
15918889|NCT03506165|Combination Product|Periodontal treatment|oral hygiene instructions, periodontal debridement and removal of other etiologic factors
15918890|NCT03506152|Diagnostic Test|Serum Procalcitonin|Seven ml of blood was drawn in gel separator tubes within 24 hours of admission in ICU for Procalcitonin determination
15918891|NCT03506139|Radiation|External beam radiation therapy|Radiotherapy to 75 Gy Radiation delivered 1 fraction / day, Monday through Friday, for a total of 30 fractions
15918892|NCT03506126|Other|Leucine|There are 8 different leucine test levels ranging from 20 to 120 mg of leucine per kilogram body weight per day (20-120 mg/kg/d)
15918893|NCT03506113|Drug|Gram stain-guided antibiotic choice|The results of Gram staining of endotracheal aspirate are used to guide the selection of antibiotics.
15918894|NCT03506113|Drug|Guidelines-based antibiotics choice|Patients are administered the combination of an anti-pseudomonal agent and anti-MRSA agent according to IDSA/ATS guidelines
15918895|NCT03506100|Other|Water Walking|Practice swimming complemented with water walking at the end of each session and those who only practice swimming. In this study participated 28 subjects (mean age, 7.68 ± 1.16 years) and was divided into two groups: swimming group (SG) (N=9) and swimming complemented with water walking group (SWWG) (N=19). The study was performed in 12 weeks with 3 moments of evaluation (M1, M2 and M3) , with two sessions per week of 45 minutes each, we wanted to identify the benefits in pulmonary function - Forced Vital Capacity (FVC), Forced Expiratory Volume in 1 second (FEV1) and Peak Expiratory Flow (PEF). The water walking activity occurred in the end of each session for 6 minutes, performed in straight line with the water level at the children's chest. The spirometry tests were realized with the microQuark Spirometer®.
15918925|NCT03505788|Drug|Acetazolamide|In the experimental group, the patient will receive the standard of care loop diuretics and acetazolamide
15918926|NCT03505788|Drug|Placebo|In the placebo group, the patient will receive the standard of care loop diuretics and the placebo
15948035|NCT03279237|Drug|Leucovorin|May help shrink tumor before surgery.
15918896|NCT03506087|Behavioral|Advance care planning coaching session.|A 60-minute in-person coaching session. The advance care planning coach, trained in motivational interviewing, will use a flexible script and checklist to assess the participant's readiness to engage in advance care planning and guide the participant forward in the process, proceeding at the participant's pace. Some participants may complete advance directives while others will not get that far. Some participants may receive a follow-up session 2-4 weeks later. Typically this 20 to 30-minute conversation will be by phone, but it may be conducted at the clinic as indicated for the participant.
15918897|NCT03506087|Behavioral|Printed advance care planning materials|Participants are provided with a folder containing an advance care planning guide developed by the Coalition for the Supportive Care of Kidney Patients for persons with Chronic Kidney Disease. The patient folder also contains the advance directive form used by the clinic that is appropriate to the state.
15918898|NCT03506074|Diagnostic Test|Flavor test|The flavor test was developed, validated and patented (patent no. 0001426253 of the Italian Ministry for the Economic Development). It consists of a series of 20 aromatic extracts, corresponding to routine dietary use flavors for Italian people. At each administration, participants were invited to identify the aromatic by making a choice from 5 proposed items. A total of 21 aromatics (including one blank) were administered sequentially. The flavor score (FS) was calculated as the sum of correctly identified aromatics and ranged from 0 to 21.
15918899|NCT03506061|Drug|Trikafta|Participants will take Trikafta which is a combination tablet comprised of 100 milligrams (mg) of elexacaftor, 50 mg of tezacaftor and 75 mg of ivacaftor (taken in the morning), and 150 mg of ivacaftor taken in the evening.
15918900|NCT03506048|Drug|Lenvatinib|Given orally once daily continuously
15918901|NCT03506035|Diagnostic Test|Research new biomarker for RA|Analyze T and B cell response against new citrullinated peptides
15918902|NCT03506022|Other|standard polysomnography|All participants were admitted in sleep laboratory and screened for one night of 8 hours employing standard polysomnography (Brainnet System - Medatec) parameters : electroencephalogram, electro-oculogram, electromyogram [chin], continuous nasal airflow body position, thoracic and abdominal strain gauges, haemoglobin oxygen saturation (SaO2) with an oximeter (Medatec) attached to finger. Blood pressure was measured in the evening during the physical examines, and then the CGMS recording startedpressure was measured in the evening during the physical examines, and then the CGMS recording started
15918903|NCT03506009|Drug|Argatroban combined with rt-PA|Argatroban as a 100-ug/kg bolus over 3 to 5 minutes was administered intravenously within 1 hour of the tPA bolus followed by a continuous Argatroban infusion of 1.0 ug/kg per minute for 48 hours adjusted to a target activated partial thromboplastin time of 1.75 X baseline (about 10%).
15918904|NCT03506009|Drug|rt-PA|Intravenous throbolysis with 0.9mg/kg rtPA.
15918905|NCT03505996|Biological|CS1001|Monoclonal antibody
15918906|NCT03505983|Device|ESR Prosthetic Foot First|Subjects will start with an ESR foot first for 1 week, then will complete an additional week with an articulating ESR foot and a powered foot for 1 week. The final 4 weeks of the study, all prosthetic feet will be available and subjects can self-select which foot to use.
15918907|NCT03505983|Device|Articulating ESR Prosthetic Foot First|Subjects will start with an articulating ESR foot first for 1 week, then will complete an additional week with an articulating ESR foot and a powered foot for 1 week. The final 4 weeks of the study, all prosthetic feet will be available and subjects can self-select which foot to use.
15918908|NCT03505983|Device|Powered Prosthetic Foot First|Subjects will start with a powered prosthetic foot first for 1 week, then will complete an additional week with an articulating ESR foot and an ESR foot for 1 week. The final 4 weeks of the study, all prosthetic feet will be available and subjects can self-select which foot to use.
15918909|NCT03505970|Dietary Supplement|Sodium bicarbonate|Sodium bicarbonate in powder form ingested in gelatine capsules. This leads to an increase bicarbonate concentration in blood, increasing buffering capacity which may lead to improvements in exercise
15918910|NCT03505970|Dietary Supplement|Maltodextrin|Maltodextrin will be used as a placebo as it will not lead to any increases in circulating bicarbonate and, at this dose, will not likely have any physiological effect.
15918911|NCT03505957|Device|SafeBreak Vascular|SafeBreak Vascular will be installed in all the IV lines of consenting participants for up to 7 days.
15918912|NCT03505944|Drug|Venetoclax|venetoclax + lenalidomide + rituximab
15918913|NCT03505931|Device|Implantation of Eluvia stent|Implantation of Eluvia stent
15918914|NCT03505918|Other|No referral for rehabilitation|Intervention is that some patients will not be refered for postoperative physiotherapy.
15918915|NCT03505905|Drug|Pregnenolone|In a sequential parallel comparison design, in a double blind placebo controlled study, the efficacy of pregnenlone treatment relative to placebo in improving depression and anxiety symptoms, cognition, sleep, quality of life and vasomotor symptoms in preimenopausal and menopausal women with MDD.
15918916|NCT03505905|Drug|Placebo|In a sequential parallel comparison design, in a double blind placebo controlled study, the efficacy of pregnenlone treatment relative to placebo in improving depression and anxiety symptoms, cognition, sleep, quality of life and vasomotor symptoms in preimenopausal and menopausal women with MDD.
15918917|NCT03505866|Behavioral|Community home-based care intervention|HIV-positive people who received community home-based care intervention on a monthly basis for six months after they enrolled in the program.
15918918|NCT03505853|Drug|Givosiran|single dose of givosiran by subcutaneous (sc) injection
15918919|NCT03505853|Drug|5-probe cocktail|includes midazolam, caffeine, losartan, omeprazole, and dextromethorphan
15918920|NCT03505840|Diagnostic Test|Ultrasound with Doppler and 3D technology|ultrasound will be made to pregnant females in 3rd trimester with doppler and 3D technology
15918921|NCT03505827|Diagnostic Test|24-2 SITA Standard Humphrey Visual Field Test|Patients participate in a 24-2 SITA Standard humphrey visual field test. This includes sitting in a dark room at a visual field machine. Stimulus test points of different intensity and size will be presented to the patient, as per SITA standard protocol. The patient will indicate by pressing a button when they see the visual stimulus.
15918922|NCT03505814|Device|High Flow Nasal Cannula Oxygen therapy (OPTIFLOW®)|High flow and humidified oxygen support for new borns and young infants for post-extubation care
15918923|NCT03505814|Device|Conventional oxygen therapy|conventional oxygen support for new born and young infants in post-extubation care
15918924|NCT03505801|Device|Confirm Rx ICM insertion procedure|Insertion of Confirm Rx ICM device
15918927|NCT03505775|Diagnostic Test|23Na magnetic resonance imaging|Imaging/diagnostic: Evaluation of the muscular and cutaneous sodium storage by 23Na magnetic resonance imaging. 23Na magnetic resonance imaging: 23NA-MRI protocol on a 3T scanner (Magnetom PRISMA, Siemens, Erlangen) implementing a 3D sequence.
15918928|NCT03505762|Drug|Cyclophosphamide|Given IV
15918929|NCT03505762|Drug|Doxorubicin Hydrochloride|Given IV
15918930|NCT03505762|Other|Laboratory Biomarker Analysis|Correlative studies
15918931|NCT03505762|Drug|Prednisone|Given PO
15918932|NCT03505762|Other|Quality-of-Life Assessment|Ancillary correlative
15918933|NCT03505762|Other|Questionnaire Administration|Ancillary studies
15918934|NCT03505762|Biological|Rituximab|Given IV
15918935|NCT03505762|Drug|Vincristine Sulfate|Given IV
15918936|NCT03505749|Behavioral|Trauma Informed Mindfulness-Based Relapse Prevention|Trauma Informed-Mindfulness-Based Relapse Prevention (TI-MBRP) will be a 4-week intervention integrating trauma intervention approaches based on Cognitive Processing Therapy (CPT) into standard Mindfulness-Based Relapse Prevention (MBRP). TI-MBRP honors the spirit and cognitive-behavioral foundation of MBRP while introducing components of CPT. Each TI-MBRP session will include mindfulness practices that bring awareness to cognitive and behavioral processes of substance abuse, and how substance use may function as a mechanism to cope with trauma symptoms. Clients are trained to observe internal, triggering stimuli without reactively attempting to avoid these experiences through substance use as well as complete exercises that promote cognitive and emotional processing of traumatic events.
15918937|NCT03505749|Behavioral|Treatment As Usual (TAU)|The Treatment as Usual (TAU) group implemented for this trial will be the standard protocol for Mindfulness-Based Relapse Prevention (MBRP). MBRP is a 4-week exposure-based intervention that integrates integrating mindfulness and acceptance-based techniques with cognitive-behavioral approaches and psycho-education to increase awareness of patterns associated with addictive behaviors and individual factors precipitating and maintaining substance use. These skills are also used to train individuals in responding skillfully in high-risk situations associated with use.
15918938|NCT03505736|Biological|Adenosine|Given IV
15918939|NCT03505736|Procedure|Magnetic Resonance Imaging|Undergo CMR imaging
15918940|NCT03505736|Drug|Regadenoson|Given IV
15918941|NCT03505736|Procedure|Stress Management Therapy|Undergo stress test
15918942|NCT03505723|Drug|Tranexamic Acid|Within 20 minutes preceding the anticipated skin incision, patients will receive intravenous TXA at a loading dose of 1g over 10 minutes, with a second 1g bolus given at the end of surgery when closing the wound.
15918943|NCT03505723|Drug|Placebo (Saline)|Within 20 minutes preceding the anticipated skin incision, patients will receive intravenous placebo (0.9% normal saline) at a loading dose of 1g over 10 minutes, with a second 1g bolus given at the end of surgery when closing the wound.
15918944|NCT03505723|Other|Perioperative hypotension-avoidance strategy|"Perioperative hypotension-avoidance strategy includes:
~Preoperative algorithm that only continues some antihypertensive medications in a stepwise manner for systolic BP ≥130 mm Hg before surgery,
~Intraoperative blood pressure targeting a mean arterial pressure (MAP) ≥80 mm Hg
~Postoperative algorithm that only continues some antihypertensive medications in a stepwise manner for systolic BP ≥130 mm Hg during the first 48 hours after surgery."
15918945|NCT03505723|Other|Perioperative hypertension-avoidance strategy|Perioperative hypertension-avoidance strategy (i.e., routine care) continues all antihypertensive drugs before and after surgery and an intraoperative BP strategy targeting a MAP ≥60 mm Hg.
15918946|NCT03505710|Drug|Trastuzumab deruxtecan (DS-8201a)|The investigational product is a sterile lyophilized powder, which is made into solution for intravenous administration.
15918947|NCT03505697|Other|inspiratory muscle training|Inspiratory Muscle Training was performed with an exercise tool (Powerbreath®) with a resistance range of 0-90. The training intensity was started with 30% of the Maximum Inspiratory Pressure (MIP) value obtained as a result of the mouth pressure measurement16, training was progressively increased from 30% to 60% considering that they were terminal-stage pulmonary disease patients. Patients were asked to perform IMT for 15 minutes, twice a day, 7 days a week, for 3 months.
15918948|NCT03505697|Other|Pulmonary rehabilitation|"Aerobic training:The aerobic exercise program consists of treadmill walking, cycle ergometer and arm ergometer training. Group exercises were performed in sets of 15 minutes each with three exercise modalities.
~Strength training:It is recommended that resistance targets are set at loads equivalent to 20 to 40% of a 1-repetition maximum (1RM) maneuver and performed between 8 to 12 repetitions for 1 to 2 sets per session.
~Home exercise programme:The program included breathing exercises (local expansion exercises, diaphragmatic breathing and pursed lip breathing), free walking, upper and lower extremity strengthening exercises with Thera-Band"
15918949|NCT03505684|Dietary Supplement|CTP|1,000 mg of CTP was orally administered per day for 12 weeks.
15918950|NCT03505684|Dietary Supplement|placebo (starch)|placebo (starch)
15918951|NCT03505671|Procedure|Acupuncture Therapy|Undergo acupuncture therapy
15918952|NCT03505671|Other|Best Practice|Receive usual care
15918953|NCT03505671|Other|Quality-of-Life Assessment|Ancillary studies
15918954|NCT03505671|Other|Questionnaire Administration|Ancillary studies
15918955|NCT03505658|Behavioral|Education and Behavior|Involves 6-weeks of education related to healthy behaviors, nutrition, and exercise.
15918956|NCT03505645|Procedure|Periarticular infiltration|"The injection will consist of the same drugs for all patients: 150mg levobupivacaine 0.25%, 10mg morphine; and 30mg ketorolac made up to a volume of 150ml with saline.
~The difference between treatment groups is how the multimodal injection is administered: either by periarticular infiltration around the knee, or by simple intra-articular injection after the knee joint capsule has been closed.
~Treatment group 1: Periarticular infiltration
~Intra-operatively after bone cuts have been made and prior to implant cementation, the multimodal injection will be infiltrated around the knee at 6 specific sites:
~Medial femoral condyle periosteum
~Medial gutter
~Lateral femoral condyle periosteum
~Lateral gutter
~Posteromedial capsule
~Posterolateral capsule"
15918983|NCT03505437|Other|Warm water condition|Warm water condition of the SECPT. Participants immerse their hand into warm water (36-37°C). Participants are neither videotyped nor monitored during the whole procedure. After the SECPT, participants will receive 45 minutes of in-vivo exposure to spiders.
15919092|NCT03504553|Other|Noise reduction|All activity will cease when the patient enters the operating room and nonessential personnel will be removed. Ambient lighting will be reduced and communication devices muted.
15918957|NCT03505645|Procedure|Intra-articular infiltration|"The injection will consist of the same drugs for all patients: 150mg levobupivacaine 0.25%, 10mg morphine; and 30mg ketorolac made up to a volume of 150ml with saline.
~The difference between treatment groups is how the multimodal injection is administered: either by periarticular infiltration around the knee, or by simple intra-articular injection after the knee joint capsule has been closed.
~After implant cementation and watertight joint capsular closure, the multimodal injection will be injected intra-articularly through the closed capsule."
15918958|NCT03505632|Device|Recruitment with low PEEP|Volume controlled ventilation with TV 6-8 ml/PBW . RR adjusted to keep the EtCO2 35-40 mmHg. I/E ratio1:2 and FiO2 0.40.Patients will receive PEEP of 5cmH2O. RM will be done by increasing the PEEP in stepwise manner. First PEEP increase to 10 cmH2O (3 breaths),then to 15 cm H2O (3 breaths) and finally PEEP raise to 20 cmH2O (10 breaths).Then PEEP decrease by 5 cmH2O increments every (3 breaths) until back to PEEP 5 cmH2O. RM will take 2 minutes. RM will be carried out at the following times: post intubation(T1) , after peritoneal insuflation(T2) ,after desuflation (T3) and before extubation(T4) . The peak airway pressure should not exceed 40 cmH2O. Monitoring of the following parameters :Dynamic lung compliance ,Horowitz index ,dead space and driving pressure .
15918959|NCT03505632|Device|High PEEP without RM|Volume controlled ventilation will carried out with tidal volume 6-8 ml/kg for predicted body weight. The PBW calculated according to the formula : 50 + 0.91 × {height (cm)-152.4} for men and 45.5 + 0.91 × {height (cm) - 152.4} for women. The respiratory rate adjusted to keep the EtCO2= 35-40 mmHg. The inspiratory to expiratory ratio (I:E ratio) 1:2 and FiO2 0.40.Patients will receive high PEEP of 15cmH2O from the start and continue all through the procedure . Monitoring of dynamic lung compliance,Horowitz index,dead space and driving pressure will be carried out at the following times: post intubation(T1) , after peritoneal insuflation(T2) ,after desuflation (T3) and before extubation(T4) . The peak airway pressure should not exceed 40cmH2O.
15918960|NCT03505619|Behavioral|ASSIST 1.0|10 weeks intervention applying a person-centred approach by using goal setting and smart products.
15918961|NCT03505606|Diagnostic Test|Visual acuity tests|Participants to have visual acuity tested with the three modified vision tests.
15918962|NCT03505593|Device|ENVUE System|The ENvizion Medical™ ENVUE™ System is designed to aid qualified operators in the placement of the ENvizion Medical™ Enteral Feeding Tube™ into the stomach or small intestine.
15918963|NCT03505567|Device|KOWA OCT Bi-µ|Non-contact, ultra-high resolution ophthalmic imaging system for fundus imaging and axial cross-sectional and three-dimensional imaging of retinal structures.
15918964|NCT03505567|Device|Optovue iVue 100|U.S. Food and Drug Administration (FDA) cleared and commercially available Optovue iVue 100
15918965|NCT03505554|Drug|Lorlatinib|100 mg QD
15918966|NCT03505541|Biological|Adiponectin and TNFa|Adiponectin and TNFa are adipokines. Will be added to the myometrial biopsies to investigate their effect on the force of contractility
15918967|NCT03505528|Drug|Nanoparticle albumin-bound paclitaxel|Abraxane is administered intravenous at a constant dose of 100mg/m2
15918968|NCT03505528|Drug|Phenelzine Sulfate|Nardil is administered orally from a starting dose of 15mg/d to a maximum of 90mg/d
15918969|NCT03505502|Drug|IV tranexamic acid|in IV tranexamic acid group they received 1-gram tranexamic acid (10 ml) in 100 ml saline infusion or placebo (110 normal saline) by slow intravenous injection at an approximate rate of 1 mL per min.In topical tranexamic acid groupA gauze soaked with 2g tranexamic acid (20 ml) diluted in 100 ml of sodium chloride 0.9% or placebo (120ml of sodium chloride 0.9%.) used to compress the myoma bed for 5 minutes. To ensure a sufficiently high concentration, the tranexamic acid was diluted only to a volume sufficient to moisten a large wound surface. 20 ml moisten at least 1500 cm2.
15918970|NCT03505489|Procedure|Deep inhalation technique|Use of deep inhalations for administration of inhalant
15918971|NCT03505489|Procedure|Tidal breathing technique|Use of tidal breathing for administration of inhalant
15918972|NCT03505489|Drug|Methacholine|Methacholine direct bronchoconstrictor used for bronchoprovocation challenge
15918973|NCT03505489|Drug|Mannitol|Mannitol indirect bronchoconstrictor used for bronchoprovocation challenge
15918974|NCT03505476|Device|Entac Medical device application|Subjects will wear a 3-inch by 3-inch stethoscope device that adheres to the skin of the abdomen via FDA approved adhesive material. It will be applied either in the operating room at the completion of surgery or in the recovery room. The device will remain on the abdomen until discharge or for 10 days, whichever comes first.
15918975|NCT03505476|Other|Patient Daily Assessment|The research team will ask questions of the subject regarding nausea, vomiting, passage of flatus, return of bowel function, and satisfaction with the device every day that the subject is hospitalized.
15918976|NCT03505476|Other|Patient Discharge Assessment|The research team will ask questions of the subject regarding satisfaction or dissatisfaction with having the device placed and attached to their abdomen.
15918977|NCT03505463|Other|Blood samples|"Three blood samples will be collected from the injured participants. The assessment points are <72 hours, 7 days and 365 days post-injury.
~One blood sample will be collected from the healthy participants. The collection will be performed as part of clinical diagnostic at the Department of Neurology at Aarhus University Hospital.
~Laboratory analysis of the collected samples comprise Flow Cytometry and assay techniques."
15918978|NCT03505463|Other|Cerebrospinal fluid sample|"Three cerebrospinal fluid samples will be collected from the injured participants. The assessment points are <72 hours, 7 days and 365 days post-injury.
~The collected samples will be analysed by Flow Cytometry and assay techniques. One cerebrospinal fluid sample will be collected from the healthy participants. The collection will be performed as part of clinical diagnostic at the Department of Neurology at Aarhus University Hospital.
~Laboratory analysis of the collected samples comprise Flow Cytometry and assay techniques."
15918979|NCT03505463|Other|Clinical examination|Clinical examinations will be performed at <72 hours, 7 days and 365 days post-injury.
15918980|NCT03505450|Other|Population Sample|full sample of recruited participants
15918981|NCT03505450|Other|Purposive sample|purposive sample of recruited participants
15918982|NCT03505437|Other|Cold water condition|Cold water condition of the SECPT. Participants immerse their hand into ice-cold water (0-3°C). During the SECPT, participants are videotyped and monitored. After the SECPT, participants will receive 45 minutes of in-vivo exposure to spiders
15919091|NCT03504566|Drug|Sulodexide|Sulodexide
15919093|NCT03504540|Procedure|Blood test|Blood test for complement factors and genetic polymorphisms of AMD analysis
15918984|NCT03505424|Other|Group 1: Standard of Care|"Those who are in Group 1 will receive the usual care which includes:
~a welcome packet from the nursing staff
~access to their infant's medical team including doctors and nurse
~opportunities to ask any questions and understand the care their baby is receiving through participation in daily work rounds or through setting up family meetings with the medical team."
15918985|NCT03505424|Other|Group 2: NICU2HOME app|In addition to the usual care made available to Group 1 as described above, Group 2 parents will receive the smartphone app. Group 2 parents will be asked to download the NICU2HOME app.
15918986|NCT03505424|Other|Group 3: SMART NICU2HOME app|In addition to the usual care made available to Group 1 as described above, Group 2 parents will receive the smartphone app. Group 3 parents will be asked to download the SMART NICU2HOME app.
15918987|NCT03505411|Dietary Supplement|melatonin supplementation|
15918988|NCT03505398|Procedure|microperimetry|define the retinal fixation point and the differential sensitivity threshold of the retina.
15918989|NCT03505398|Procedure|visual acuity|using ETDRS scales
15918990|NCT03505398|Procedure|automated visual field|recording visual attention based on central or peripheral visual information
15918991|NCT03505398|Procedure|eye movements recording|recording of explicit visual attention based on central or peripheral visual information
15918992|NCT03505385|Behavioral|Co-created intervention - Get Ready (GR)|"The Get Ready (GR) intervention was delivered one-to-one with the care home resident and a relevant family member during a 12-week period:
~The familiarisation stage aimed to build a rapport with two long-term achievement goals to sit less and move more with the resident and the family member and consisted of two sessions, one in week 1 (50-60minutes) and the other in week 3 (30-40 minutes).
~The ramping up stage aimed to review the rapport and reach an achievable consensus with the resident and the family member. It consisted of two sessions, one in week 5 and the other in week 7 (20-30 minutes each).
~The maintenance stage aimed at integrating behaviours and included two sessions, one in week 9 and the other at week 12 (20-30 minutes each). Sessions 5 and 6 were used to understand how the resident was getting on with their short-term GR goals, facilitating some problem-solving discussions."
15918993|NCT03505372|Device|Contrast enhanced mammography|Contrast enhanced mammography is a new type of mammogram that uses contrast material combined with the mammogram to highlight areas that might be breast cancer and that could be missed on the mammogram alone.
15918994|NCT03505359|Other|partial knee immobilization protocol|12 weeks rehabilitation protocol including exercises to improve range of motion, gait, balance, muscle strength with a 0-60 degrees articulated knee brace in the first 6 weeks in the experimental group.
15918995|NCT03505359|Other|standard ACL reconstruction rehabilitation protocol|12 weeks rehabilitation protocol including exercises to improve range of motion, gait, balance, muscle strength.
15918996|NCT03505346|Drug|68Ga-NODAGA-E[c(RGDyK)]2|200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV.
15918997|NCT03505333|Procedure|conventional suture|we use Liga-sure device for hysterectomy
15918998|NCT03505320|Drug|zolbetuximab|Zolbetuximab will be administered as a minimum 2-hour IV infusion.
15918999|NCT03505320|Drug|oxaliplatin|Oxaliplatin will be administered as a 2-hour IV infusion.
15919000|NCT03505320|Drug|leucovorin|Leucovorin will be administered as a 2-hour IV infusion.
15919001|NCT03505320|Drug|fluorouracil|Fluorouracil will be administered as IV bolus over 5 to 15 minutes and continuous IV infusion over 46 to 48 hours or per institutional guidelines.
15919002|NCT03505320|Drug|Pembrolizumab|Pembrolizumab will be administered intravenously over 30 minutes.
15919003|NCT03505320|Drug|folinic acid|Folnic acid will be administered as a 2-hour IV infusion.
15919004|NCT03505320|Drug|nivolumab|Nivolumab will be administered intravenously according to institutional standards.
15919005|NCT03505294|Other|Task-oriented training|"Task-oriented training consisting of 10 different motor tasks including lower extremity and upper extremity activities will be applied to the training group twice a week for 6 weeks."
15919006|NCT03505281|Biological|Blood samples|Collection of two additional tubes at the time of a blood test necessary for patient follow-up.
15919007|NCT03505268|Behavioral|Telemedicine|Patients of the Intervention Group will have once biweekly telephonic intervention conversation with dietitian, specialized in diabetes and diabetes nurse. The patients of the control group will have a routine care.
15919008|NCT03505255|Drug|Neostigmine|Neostigmine is a cholinesterase-inhibitor, which augments the concentration of acetylcholine (ACh) at the neuromuscular junction
15919009|NCT03505255|Other|Normal saline|Normal saline 0.9 % is given in the control group
15919010|NCT03505242|Device|bronchial blocker for BB group|Using bronchial blocker to block right middle lower lobe during surgery.
15919011|NCT03505242|Device|double lumen tube for DLT group|Using double lumen tube to achieve single lung ventilation during surgery.
15919012|NCT03505229|Radiation|Stereotactic Body Radiotherapy (SBRT)|Stereotactic Body Radiotherapy (SBRT) 30-45 gray in 5 fractions over 2 weeks will be given to all eligible patients.
15919013|NCT03505203|Behavioral|Sleep Soothe|An intervention in which parents are given information on how to respond to their baby's cues related to sleeping and fussiness.
15919014|NCT03505203|Behavioral|Sleep Safe|An intervention in which parents are given information on a safe sleep environment, as well as other strategies to keep baby safe.
15919015|NCT03505190|Drug|RO7062931|RO7062931 will be administered SC in single ascending doses with starting of 0.3 mg/kg and subsequent doses of 1.0 mg/kg, 2.0 mg/kg and 3.0 mg/kg, respectively. Additional (optional) dose of 4.0 mg/kg may be administered based on safety, tolerability and PK data.
15919016|NCT03505190|Drug|Placebo|Matching placebo will be administered subcutaneously (SC).
15919017|NCT03505177|Dietary Supplement|Chitin-glucan fiber|4.5g per day of chitin-glucan during 3 weeks
15919018|NCT03505151|Drug|BI 409306 (C-13/N-15)|i.v solution
15919019|NCT03505151|Drug|BI 409306|Film-coated tablet
15919020|NCT03505138|Device|Group intervention|"GROUP 1 (telematic group):
~These patients will have a tablet connected via internet (Telefónica-e-Health). They have to measure their lung function, temperature, pulse oxymetry and symtoms questionnaire every week. The device (tablet) asks them about possible COPD exacerbation. If the patient has an exacerbation, the device offers them a treatment for this exacerbation and it begins a following of this exacerbation until resolution, every day.
~The pneumologists will receive an alert in other tablet when the patients have an exacerbation or worsening of their diseases.
~The period of monitoring is 1 year."
15919021|NCT03505138|Other|health care system|"GROUP 2 (conventional group or control group) Patients with a COPD exacerbation can go to their family physicians or emergency services and these physicians will establish a treatment and a monitoring of these exacerbation (conventional group).
~The period of monitoring is 1 year."
15919022|NCT03505112|Other|Goal-directed therapy|"The patients in GDT group will receive intravenous crystalloid fluid or vasopressor or inotropic agent according to the goal-directed therapy protocol utilizing FloTrac / EV1000 clinical platform (Edwards Lifesciences, Irvine, CA, USA).
~After induction of anesthesia, the baseline stroke volume index (SVI) is measured and then 200-250 ml of crystalloid is administered over 5-10 minutes. If SVI increase by ≥10%, 200-250 ml of crystalloid is given repeatedly until the increase in SVI <10%. If SVI does not increase by ≥10% and there is no decrease in mean arterial pressure (MAP), revaluate SVI every 10 minutes. Despite an increase in SVI of <10% after fluid challenge, if a decrease in MAP is accompanied by cardiac index (CI) ≤ 2.5 L/min/m2, dobutamine is administered by continuous infusion. If there is a decrease in MAP but no decrease in CI, start low dose norepinephrine continuous infusion."
15919023|NCT03505099|Biological|onasemnogene abeparvovec-xioi|A non-replicating recombinant AAV9 containing the complimentary deoxyribonucleic acid (cDNA) of the human SMN gene under the control of the cytomegalovirus (CMV) enhancer/chicken-β-actin-hybrid promoter (CB). The AAV inverted terminal repeat (ITR) has been modified to promote intramolecular annealing of the transgene, thus forming a double-stranded transgene ready for transcription.
15919024|NCT03505086|Diagnostic Test|Blood withdrawal|"Blood withdrawal will be at regular sampling moments, blood can be collected from a central venous catheter or venepuncture procedure.
~Blood withdrawal will be performed for a maximum of 10 times per admission, 10 ml per time.
~Urine sampling will be for a maximum of 5 times per admission.
~Urine can be sampled from a catheter when present, or collected regular."
15919025|NCT03505086|Other|Questionnaire for former bleeding events|Questionnaire to investigate a bleeding tendency before diagnosis.
15919026|NCT03505060|Biological|DNA CON-S env|Administered by intramuscular injection in the deltoid.
15919027|NCT03505060|Biological|IHV01|Administered by intramuscular injection in the deltoid.
15919028|NCT03505060|Biological|Placebo|Sodium Chloride for Injection, USP 0.9%; administered by intramuscular injection in the deltoid.
15919029|NCT03505047|Device|Copper Intrauterine device|Immediate insertion of the copper intrauterine device after completion of abortion
15919030|NCT03505034|Drug|Umbilical Cord Mesenchymal Stem Cells|Intrathecal Transplantation of Umbilical Cord Mesenchymal Stem Cells, 1*10^6 cells/kg, once a month for 4 months
15919031|NCT03505021|Drug|Levosimendan|Levosimendan 1 mg capsule for oral administration
15919032|NCT03505021|Drug|Placebo for levosimendan|Placebo capsule for oral administration
15919033|NCT03505008|Drug|Methotrexate|Route of Administration: Oral
15919034|NCT03505008|Drug|Adalimumab|Route of Administration: Subcutaneous
15919035|NCT03504995|Device|Focal irreversible electroporation of the prostate cancer|Irreversible electroporation is a non-thermal tissue ablation technique in which short duration electrical fields are used to permanently permeabilize the cell membrane.
15919036|NCT03504982|Drug|Vericiguat (BAY1021189)|A : 2.5 mg vericiguat A*: 2.5 mg vericiguat B : 5 mg vericiguat C : 10 mg vericiguat C*: 10 mg vericiguat
15919037|NCT03504982|Drug|Moxifloxacin|D: 400 mg moxifloxacin
15919038|NCT03504982|Drug|Placebo|A : vericiguat placebo 10 mg A*: vericiguat placebo 10 mg + moxifloxacin placebo B : vericiguat placebo 10 mg C : vericiguat placebo 2.5 mg C*: vericiguat placebo 2.5 mg + moxifloxacin placebo D : vericiguat placebo 2.5 mg + vericiguat placebo 10 mg
15919039|NCT03504956|Device|Cardiac MRI|MRI with/without administration of a contrast agent and beta-blocker based upon the stage of method development, if no contraindications are present.
15919040|NCT03504956|Drug|Contrast|The intravenous gadolinium based contrast agent to be used in this study is Gadavist (up to 0.2 mmol/kg).
15919041|NCT03504956|Drug|Beta blocker|Based upon the focus of the study at the time of the scan, a beta- blocker (metoprolol), in pill form based upon blood pressure and heart rate, may be administered to some subjects to improve the heart's ability to relax and slow the heart rate. The slower heart rate may improve image quality and lessen motion artifact.
15919042|NCT03504943|Other|Early Intradialytic Exercise|Timing of intradialytic exercise first half of HD
15919043|NCT03504943|Other|Late Intradialytic Exercise|Timing of intradialytic exercise second half of HD
15919044|NCT03504930|Other|Impact of biotherapy on postoperative morbidity in ulcerative colitis|Impact of biotherapy on postoperative morbidity, quality of life, sexual function, sexual health in ulcerative colitis
15919047|NCT03504904|Behavioral|Internet-Delivered ACT and CFT|An 8-week internet-based intervention focused on acceptance and compassion. Psychological intervention based on Acceptance and commitment therapy and compassion focused therapy
15919048|NCT03504891|Diagnostic Test|MRI prior to CRT Upgrade|We will perform MRI prior to CRT to inform the optimal CRT implantation strategy in patients with existing devices undergoing upgrades versus those with de novo CRT implants. We will compare outcomes in the two groups.
15919049|NCT03504891|Diagnostic Test|MRI prior to de novo CRT|We will perform MRI prior to de novo CRT implants as the comparison group.
15919050|NCT03504878|Procedure|Laparoscopic appendectomy|The laparoscopic appendectomy was performed with three trocars. Pneumoperitoneum was created using an open Hasson technique. The mesoappendix was divided using a harmonic scalpel or endoscopic tissue fusion device. The appendix was divided by placing one endoscopic loop and cut with harmonic scalpel. The specimen was removed through the umbilical port.
15919051|NCT03504878|Procedure|Open appendectomy|The open appendectomy was carried out in the standard way with McBurney muscle splitting incision.
15919052|NCT03504865|Drug|Liposomal bupivacaine|Given at the end of the operation.
15919053|NCT03504865|Drug|Standard bupivacaine|Given at the end of the operation.
15919054|NCT03504865|Other|Placebo|Saline will be administered as the placebo and will be given at the end of the operation.
15919055|NCT03504852|Drug|secukinumab 150 mg|sub-cutaneous secukinumab prefilled syringe 150 mg
15919056|NCT03504839|Device|Subcutaneous ICD with same day discharge|Receiving a SICD and discharged the same day
15919057|NCT03504826|Device|Hybrid Assistive Limb (HAL)|Intensive training with the HAL consisting of two components to the intervention session that include: 1) locomotor treadmill training with the HAL device and 2) locomotor training over ground without the HAL device. All training will be overseen by a licensed physical therapist.
15919058|NCT03504813|Other|Physical activities program|To implement this line, the protocol of the VIVIFRAIL Project will be used as a reference. That protocol has different physical exercises, divided into itineraries, in order to adapt it to a person's capability. Several sessions of this research line will employ the use of videogames so that the elderly can explore new forms of physical activity and thus establish contact and expertise with new technologies. It is estimated that two sessions per week over two months are needed for each person to continue doing physical activity independently and with autonomy.
15919059|NCT03504813|Other|Relaxation training|Will take place with those participants who are included in the research lines of insomnia and risk of falls. It is estimated that two sessions per week for one month are needed.
15919060|NCT03504813|Other|Training of the pelvic floor|the intervention will apply to participants enrolled in the research line dealing with urinary incontinence during the six months of intervention, with a frequency of two sessions per week
15919061|NCT03504813|Behavioral|Counseling about occupational performance|After the physical activity and relaxation programs, the counselling will start. With each participant, routines and daily activities will be planned that will be adequate according to different recommendations about urinary incontinence, insomnia and risk of falls. Different performance guidelines will be established in order to establish a good balance between activities. The guidelines can include the recommendations about adjustments to the environment. It is estimated that three sessions per week for two months are needed to incorporate advice and routines into the daily lives of participants.
15919062|NCT03504800|Device|Optical Coherence Tomography|This device will be used to tightly classify corneal irregularities and determine eligibility of candidates from Group A into Groups B & C.
15919063|NCT03504774|Drug|Cashew or Shrimp Oral Immunotherapy|All cohorts will undergo an updosing regimen starting at 5 mg allergen, with dose escalation every 2 weeks to reach a 1000 mg dose at week 28, after which they will be maintained at that dose for 24 weeks. At the conclusion of the maintenance phase (Week 52), participants will undergo DBPCFC.
15919064|NCT03504761|Device|ClariCore Optical Biopsy System|Demonstrate the efficacy and safety of the ClariCore System in obtaining prostate biopsies utilizing real-time tissue classification.
15919065|NCT03504748|Device|deep rTMS|
15919066|NCT03504748|Device|placebo deep rTMS|
15919067|NCT03504735|Behavioral|Therapeutic Lifestyle Change|Monthly consult with a dietitian and fitness instructor.
15919068|NCT03504735|Drug|Caduet Pill|Take once daily.
15919069|NCT03504735|Drug|Placebo|Take once daily.
15919070|NCT03504722|Behavioral|RESCUE|RESCUE is designed to adapt to individualized needs based on each veteran's performance. The volunteer training consists of weekly sessions lasting 90 minutes each and occurring at area SPCA facilities. The logistics of the training sessions will be facilitated by study staff, with SPCA animal behaviorists and professionals conducting the training program identical to the program that they use for their general volunteer training. During volunteer sessions, the veteran learns behavioral techniques for training non-aggressive dogs through didactic instruction followed by demonstration and supervised practice. The animal socialization component of the RESCUE volunteer sessions are comprised of the SPCAs current training program, which is designed developmentally such that early training focuses on general topics (safety, basic handling skills) and later training builds on previously learned skills through successive approximation within each individual's zone of proximal development.
15919071|NCT03504722|Behavioral|Prolonged Exposure|All veterans will receive individualized, evidence-based prolonged exposure therapy. Foa's PE protocol will be used given consensus statements indicating that exposure therapy is currently the most appropriate psychotherapy for PTSD. Study therapists are already trained clinicians through the VA's PE certification process and will receive weekly supervision for all cases from the PI, who is a national Prolonged Exposure trainer.
15919072|NCT03504696|Other|Non-interventional|Non-interventional
15919073|NCT03504683|Behavioral|Early Time-Restricted Feeding|Eat between 8 am - 3 pm (or 7 am - 2 pm, if an early riser)
15919074|NCT03504683|Behavioral|Mid-day Time-Restricted Feeding|Eat between 1 pm - 8 pm (or 12 pm - 7 pm, if an early riser)
15919075|NCT03504683|Behavioral|Control Schedule|Eat between 8 am - 8 pm (or 7 am - 7 pm, if an early riser)
15919076|NCT03504670|Procedure|Early Amniotomy|This intervention involves using an amniotomy hook to rupture the membranes during a sterile vaginal exam. This intervention will be performed prior to the cervix being dilated 4cm.
15919077|NCT03504670|Procedure|Late Amniotomy|This intervention involves using an amniotomy hook to rupture the membranes during a sterile vaginal exam. This intervention will be performed once the cervix is at least 4cm dilated.
15919078|NCT03504657|Device|Drug-coated balloon angioplasty|Angioplasty with a drug-coated angioplasty
15919079|NCT03504657|Device|stenting angioplasty|Angioplasty with a stenting
15919080|NCT03504644|Other|Laboratory Biomarker Analysis|Correlative studies
15919081|NCT03504644|Drug|Venetoclax|Given PO
15919082|NCT03504644|Drug|Vincristine Liposomal|Given IV
15919083|NCT03504631|Other|No intervention|no intervention
15919084|NCT03504618|Drug|FOLFOXIRI|"Treatment of FOLFOXIRI regimen at first line with dosage:
~Irinotecan: 165 mg / m2, intravenous infusion for 1 hour. Day 1, 15. Oxaliplatin: 85 mg / m2, intravenously for 2 hours Day 1, 15 Calcium folinate 200 mg / m2, intravenously for 2 hours Day 1, 15 5FU 3200 mg / m 2, intravenous infusion continuously for 48 hours Day 1, 2, 3, 15, 16, 17 Every 4 weeks. Each cycle has 2 infusion times, the first one is the first day, the second one is the 15th day"
15919085|NCT03504605|Other|Online self-compassion intervention|Parents are asked to write in an online text box about a parenting event in which they felt shame. They are then given a validated set of instructions asking them to reflect on the event and write self-compassionate responses.
15919086|NCT03504592|Behavioral|Completion of Glucose logs|Glucose logs will be assessed by provider for completeness and accuracy
15919087|NCT03504579|Other|rt-fMRI neurofeedback|use of real time fMRI neurofeedback to achieve targeted brain changes
15919088|NCT03504566|Drug|Linagliptin|Linagliptin
15919089|NCT03504566|Drug|Empagliflozin|Empagliflozin
15919090|NCT03504566|Drug|Telmisartan|Telmisartan
15919095|NCT03504527|Drug|double combinations|inhaled formotero(4.5ug,bid) and tiotropium bromide(18μg,qd)
15919096|NCT03504514|Device|speech trials during different ventilation conditions|ventilator parameters are modified
15919097|NCT03504514|Other|speech trial|reading duration, vocal flow, intelligibility and voice quality will be evaluated during speech
15919098|NCT03504501|Drug|Lovastatin|oral application prior to transcranial magnetic stimulation intervention
15919099|NCT03504501|Drug|Lamotrigine|oral application prior to transcranial magnetic stimulation intervention
15919100|NCT03504488|Biological|CAB-ROR2-ADC|Conditionally active biologic anti-ROR2 antibody drug conjugate
15919101|NCT03504488|Biological|PD-1 inhibitor|PD-1 inhibitor
15919102|NCT03504475|Drug|Paroxetine Hydrochloride Tablet 20 mg|A generic product manufactured by Beijing Winsunny Pharmaceutical Co., Ltd.
15919103|NCT03504475|Drug|Paxil® 20 mg|Paxil® Tablet 20 mg will be used as a comparator drug for the bioequivalence study, manufactured by GlaxoSmithKline（Distributed by: Apotex Corp.）.
15919104|NCT03504462|Procedure|Specific block of medial and lateral plantar nerves|"Specific injection of long duration local anesthetic in contact with medial and lateral plantar nerves.
~Local anesthetic : Ropivacaine : 0,375% - 5 ml per nerve."
15919105|NCT03504449|Other|neoadjuvant chemoradiotherapy|
15919106|NCT03504436|Device|LEO +|LEO +: self-expanding intracranial stent
15919107|NCT03504423|Drug|CPI 613, mFolfirinox|CPI-613: 500mg/m2, IV infusion at a rate of 4mL/min via a central venous port. mFolfirinox: given immediately after CPI-613 administration
15919108|NCT03504423|Drug|Folfirinox|Folfirinox
15919109|NCT03504410|Drug|CPI-613 + High Dose Cytarabine and Mitoxantrone|CPI-613 + High Dose Cytarabine and Mitoxantrone CPI-613: 2000mg/m2, 5 doses once a day, days 1-5 Cytarabine 1gm/m2, 5 doses every 12hrs starting day 3 through day 5 Mitoxantrone 6mg/m2, 3 doses, once a day following the first, third and fifth doses of Cytarabine
15919110|NCT03504410|Drug|High Dose Cytarabine and Mitoxantrone|Cytarabine 1gm/m2, 5 doses every 12hrs starting day 3 through day 5 Mitoxantrone 6mg/m2, 3 doses, once a day following the first, third and fifth doses of Cytarabine
15919111|NCT03504410|Drug|Mitoxantrone, Etoposide and Cytarabine|"Mitoxantrone, Etoposide and Cytarabine
~Etoposide 80mg/m over 60 minutes as a central line IV infusion; 6 doses Day 1 though 6 Cytarabine 1000mg/m2 over 3 hours as a central line IV infusion: 6 doses, Day 1 through 6 Mitoxantrone 6 mg/m2 over 30 minutes as a central line IV infusion: 6 dose, Day 1 through 6"
15919112|NCT03504410|Drug|Fludarabine, Cytarabine, Filgrastim|"Fludarabine, Cytarabine and Filgrastim
~Fludarabine 30mg/m2/day over 30 minutes as a central line IV infusion; 5 doses Day 1 though 5 Cytarabine 2g/m2 over 4 hours as a central line IV infusion: 4 hours after Fludarabine: 5 doses, Day 1 through 5 Filgrastim 5µg/kg/day by SQ or as per institutional guidelines starting from Day 1 through Day 5"
15919113|NCT03504397|Drug|zolbetuximab|Zolbetuximab will be administered as a minimum 2-hour IV infusion.
15919114|NCT03504397|Drug|placebo|Placebo will be administered as a minimum 2-hour IV infusion.
15919115|NCT03504397|Drug|oxaliplatin|Oxaliplatin will be administered as a 2-hour IV infusion
15919116|NCT03504397|Drug|folinic acid|Folinic acid will be administered as a 2-hour IV infusion.
15919117|NCT03504397|Drug|fluorouracil|Fluorouracil will be administered as IV bolus over 5-15 minutes and continuous IV infusion over 46-48 hours.
15919118|NCT03504384|Other|questionnaire|All patients will be interviewed using a semi-structured questionnaire detailing patients' demographic characteristics (age, sex, education, occupation, residence), and the factors that could affect their quality of life such as pain and neurological symptoms, orthopedic disorder in another part of the body and history of spinal surgery.
15919119|NCT03504371|Device|bilateral erector spinae block|The patient placed in a lateral position and transducer placed in a longitudinal orientation 3 cm lateral to the T7 spinous process. Three muscles will be identified superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. An 8-cm 22-gauge block needle will be inserted in a cephalad-to-caudad direction until the tip lay in the interfascial plane between rhomboid major and erector spinae muscles, as evidenced by visualization of local anesthetic spreading in a linear pattern between erector spinae and the bony acoustic shadows of the transverse processes. 20 mL of 0.25% bupivacaine will be injected then it will be repeated on the other side and preformed in the same way to achieve sensory block T5-T10 .
15919120|NCT03504371|Device|Thoracic epidural anesthesia|patients will receive TEA where an epidural catheter will be placed at the T7-8 interspace after proper sterilization and positioning of the patient in the sitting position then standard technique of application will be applied, then a test dose consists of 3 ml of 1.5% preservative free lidocaine with 1:200,000 epinephrine will be injected followed by 5-6 ml of bupivacaine 0.25%.
15919121|NCT03504358|Procedure|Liver resection|Partial hepatectomy comprised single or multiple hepatic resections aiming at excising all visible malignant tissue.
15919122|NCT03504345|Drug|Prometrium|The intervention will involve delaying the transfer of a frozen-thawed embryo into the uterus to increase the duration of progesterone exposure.
15919123|NCT03504332|Procedure|intracanal disinfection in revascularization|a procedure to create vital cells in the pulp space of immature teeth which enables thickening of the dentinal walls of the root.
15919124|NCT03504319|Other|Exposure to high-fat smoothie|Both groups will drink the high-fat smoothie and the study team will observe how they respond metabolically in the subsequent four hours using metabolic analyzer and blood draws.
15919125|NCT03504306|Other|Ventriject validation|comparing measurements from echocardiography, echoseismography to measurements of maximal oxygen uptake
15919126|NCT03504293|Procedure|Combinatory EUS and ERCP|EUS performed as a supplementary procedure in addition to ERCP
15919127|NCT03504280|Drug|Cholecalciferol|
15919128|NCT03504267|Other|Physical Activity Education and Resources|The intervention involves receiving evidence-based educational brochures as well as a list of local facilities where the participant can work out at no-cost to them,
15919129|NCT03504254|Diagnostic Test|MRI examination|Three kinds of MRI techniques will be used in this study. These are (1) axial T1-weighted (T1WI) and T2-weighted imaging (T2WI), UTE MRI, (2) BOLD-based fMRI, and (3) diffusion tensor imaging (DTI).
15919130|NCT03504241|Biological|Donor-derived Mesenchymal Stromal Cells|These MSCs are a cellular product derived from bone marrow and propagated ex vivo using FDA-approved, clinically applicable methods. Their use in kidney transplantation has been associated with a good safety profile.
15919131|NCT03504241|Drug|alemtuzumab|Alemtuzumab, 30 mg, given once intravenously (IV) over three hours. The infusion of alemtuzumab shall begin within 24 hours of transplantation surgery and shall be given prior to the first dose of belatacept.
15919132|NCT03504241|Drug|belatacept|Belatacept will be given as an intravenous (IV) infusion of 10mg /kg over 1 hour on transplantation postoperative Day 0, Days 5 and 14, then every 2 weeks (± 2 days) for 5 additional doses.Thereafter, belatacept will be given once every 4 weeks (± 5 days) at 10 mg/kg through 24 weeks post-transplant, then at 5 mg/kg every 4-weeks until the participant is evaluated for belatacept discontinuation.
15919133|NCT03504241|Drug|sirolimus|Rapamune® (sirolimus) (Wyeth Pharmaceuticals Inc., Philadelphia, PA) will be started on transplantation postoperative day 1 at a dose of 2 mg/day orally and adjusted to maintain goal 24-hour trough levels of 8-10 ng/ml. Participants who experience grade 3 sirolimus toxicity will undergo dose reduction.
15919134|NCT03504241|Drug|mycophenolate mofetil|Per protocol, and, only permitted in cases of sirolimus intolerance.
15919135|NCT03504241|Drug|mycophenolate acid|Per protocol, and, only permitted in cases of sirolimus intolerance.
15919136|NCT03504241|Drug|prednisone|Per protocol, and, only permitted in cases of sirolimus intolerance.
15919137|NCT03504228|Device|Roadsaver|Dual layer micromesh Roadsaver carotid stent
15919138|NCT03504215|Other|Exercise Intervention|Assigned intervention : 14-week supervised intervention of aerobic and resistance training.
15919139|NCT03504202|Drug|Trimetazidine|After enrollment, experimental group will receive Trimetazidine(35mg tid) for six months .
15919140|NCT03504189|Device|PregSense™|PregSense™ wearable device will be applied for maternal-fetal monitoring
15919141|NCT03504189|Device|Cardiotocopraphy (CTG)|Cardiotocopraphy (CTG) will be applied for maternal-fetal monitoring
15919142|NCT03504176|Other|Ventilation bundle|ventilation targets (pH, spO2, pCO2) tidal volume 3-6ml/kg peak pressures <28-32cmH2O PEEP-FiO2 titration tables
15919143|NCT03504163|Drug|Pembrolizumab (MK-3475)|Pembrolizumab (MK-3475) will be administered as a 200 mg IV infusion at 3-week intervals for 9 doses over a 24 week period.
15919144|NCT03504150|Behavioral|SPHERE|Comprehensive Internet-based CBT program with no human support
15919145|NCT03504150|Behavioral|PRISM|Brief Internet-based CBT program with no human support
15919147|NCT03504124|Other|Multicomponent intervention|An 18-month multicomponent intervention, which includes protocol-based treatment using: a standard blood pressure (BP) management algorithm, team-based collaborative care, BP audit and feedback, home BP monitoring, and health coaching on antihypertensive medication adherence and lifestyle modification.
15919148|NCT03504111|Procedure|Percutaneous Needle Tenotomy|A sham phlebotomy sample will be drawn on all study participants. Participants in this treatment group will be given local anesthesia with 1% lidocaine and then blinded to the intervention using a blind fold or shielding. Ultrasound guided needle tenontomy with be performed at the common extensor tendon at the area of tendinosis. There will be approximately 25 passes through the tendon with an 18 gauge needle. Investigators will keep track of the number of passes through the tendon. Investigators will keep track of the amount and type of anesthetic used to provide adequate and effective anesthesia
15919149|NCT03504111|Procedure|PRP|A sham phlebotomy sample will be drawn on all study participants. Participants in this treatment group will be given local anesthesia with 1% lidocaine and then blinded to the intervention using a blind fold or shielding. Ultrasound guided injection of the PRP will be performed at the common extensor tendon at the area of tendinosis. Investigators will keep track of the amount and type of anesthetic used to provide adequate and effective anesthesia to the local skin
15919150|NCT03504098|Behavioral|nutrition consult|Post-lung cancer operation diet pattern
15919151|NCT03504085|Other|Yoga: Active Hatha|Classical Hatha yoga with influences from Viniyoga and Iyengar yoga. Both Viniyoga and Iyengar yoga styles emphasize modifications and adaptations including the use of props such as straps and blocks in order to minimize the risk of injury and make the poses accessible to people with health problems and limitations
15919152|NCT03504085|Other|Yoga: Restorative|Restorative Yoga is a slow-paced yoga style that emphasizes relaxation and includes very little movement.
15919153|NCT03504072|Drug|Tofacitinib 5 mg,|tofacitinib 5 mg 12 hourly daily for 9 months
15919154|NCT03504072|Drug|Etanercept|Etanercept 50 mg sc every 7 days interval in 1st month, every 15 days interval in 2nd month and then every 21 days interval from 3rd month onward upto 9 months
15919155|NCT03504059|Behavioral|Long-term educational program|Comprehensive educational school-based intervention in adolescents on cardiovascular health, including obesity/adiposity and metabolic profiles, through classroom intervention, and complementary intervention in the family setting, at school and on teachers.
15919156|NCT03504059|Behavioral|Short-term educational program|Comprehensive educational school-based intervention in adolescents on cardiovascular health, including obesity/adiposity and metabolic profiles, through classroom intervention, and complementary intervention in the family setting, at school and on teachers.
15919157|NCT03504046|Device|Artificial Pancreas App|The portable Artificial Pancreas System App (APS APP) is an artificial pancreas system comprised primarily of an insulin pump, a continuous glucose monitor (CGM), and a cellular phone device to connect the components.
15919158|NCT03504033|Drug|Xenon|inhalation to maintain anesthesia
15919159|NCT03504033|Drug|Desflurane|inhalation to maintain anesthesia
15919160|NCT03504020|Device|ECG Belt Research System|The ECG Belt Research System is used to identify the best vector and programming parameters.
15919161|NCT03503994|Drug|Inhaled Beclomethasone Dipropionate Monohydrate|"Beclomethasone Dipropionate (HFA-BDP, QVAR*) in the following doses will be evaluated:
~200 mcg bid
~400 mcg bid
~600 mcg bid
~800 mcg bid"
15919162|NCT03503981|Other|Psychotherapy|There are different psychotherapy models offered across the units. All patients receive individual treatment and group therapy or psychoeducative groups.
15919163|NCT03503968|Drug|MDG1011|PRAME-T-Cell Receptor Gene Modified Autologous T Cells
15919164|NCT03503968|Other|Investigator Choice therapy|Any intervention/therapy chosen by the investigator
15948038|NCT03279237|Radiation|Radiation Therapy|May help shrink tumor.
15919165|NCT03503955|Other|Leap-Motion virtual reality games|Games that Fizyosoft has prepared on Leap Motion equipment to improve hand and grip activities will be played individually and will focus on running hand, wrist and grip movements
15919166|NCT03503955|Other|fine motor skills activities|activities that stimulate finger movements such as holding, reaching, catching, writing, and strengthening muscles
15919167|NCT03503942|Behavioral|Lifestyle modification|Participants in the treatment arm will receive structured, locally tailored, group-based lifestyle interventions that consist of a core intervention phase (3 months) and a maintenance phase (33 months). The core intervention phase will consist of twice weekly group sessions on nutrition, exercise and goal-setting within the first 6 weeks followed by 6 weeks of self-directed lifestyle modification. During the maintenance phase, the participants will receive monthly short message service (SMS) on health tips as well as 6 monthly telephone calls from program coordinators.
15919168|NCT03503942|Drug|Metformin|Metformin will be will be prescribed to treatment group participants at highest risk of diabetes conversion (i.e.IFG + IGT or IFG + HbA1c ≥6.0%) after at least 6 months of lifestyle interventions at a starting dose of 250 mg twice a day followed by up-titration to 500 mg twice a day after 3 months if the participants do not experience any gastrointestinal side effects.
15919169|NCT03503942|Other|Financial incentives|Participants will be given cash incentives if they meet the weight loss target, which is pre-defined as 5% of baseline weight, at the 3rd, 6th, 12th, 18th, 24th, 30th and 36th month of study period.
15919170|NCT03503929|Device|LaparoGuard System|Adjunctive safety system for laparoscopic surgery
15919171|NCT03503903|Procedure|Wet Cupping|CT was applied using plastic disposable vacuum cups on the back in the 5 areas of C7 cervical spine (DU14 acupoint), T2-4 lateral spine bilaterally (BL41-42 acupoint) and T6-8 lateral spine bilaterally (BL44-46), which are the recommended sites for headache (12). The cupping technique procedure was conducted in five phases:Primary suction,Area disinfection,Scarification,Secondary suction and bloodletting,Removing and dressing.
15919172|NCT03503890|Drug|rovalpituzumab tesirine|intravenous
15919173|NCT03503877|Device|EmbryoScope Plus|All embryos will be cultured in the EmbryoScope Plus to obtain morphokinetic data
15919174|NCT03503877|Other|GLOBAL MEDIA|Embryos will be cultured in GLOBAL media
15919175|NCT03503877|Other|SAGE MEDIA|Embryos will be cultured in SAGE media
15919176|NCT03503864|Drug|Arsenic Trioxide|Arsenic trioxide（ATO） is administered 0.16mg/kg per day over eight hours IV daily for ten days. Patients will receive ATO alone on days 1-2 and combined with conventional induction chemotherapy on days 3-10. Nine cycles at most of ATO-combined chemotherapy were applied in the whole scheme.
15919177|NCT03503851|Device|MitraClip implantation|Device to approximate the mitral valve leaflets
15919178|NCT03503838|Behavioral|Online Yoga|12 weeks of online yoga; 60 min/week
15919179|NCT03503825|Drug|[Tc-99m]-RPI-T-087 Injection|A single intravenous injection of [Tc-99m]-RPI-T-087 followed by SPECT/CT imaging of the knee (all subjects) and whole body planar imaging (Healthy volunteers only)
15919180|NCT03503812|Behavioral|Intervention (1) for outdoor exposure reduction - Asthma in Children|"Intervention 1 (I1) aims to reduce exposure to outdoor particles and it will be applied on days with DDS during the 4-month period. This intervention will consist of two recommendations:
~Reduce time spent outdoors and
~Reduce physical activity"
15919181|NCT03503812|Behavioral|Intervention (2) for outdoor and indoor exposure reduction - Asthma in Children|"Intervention 2 (I2) aims to reduce both:
~i) exposure to outdoor particles and it will be applied on days with DDS during the 4-month period. This intervention will consist of two recommendations:
~Reduce time spent outdoors and
~Reduce physical activity
~ii) indoor particle levels on a continuous daily basis throughout the 4-month DDS period. This intervention will consist of two recommendations for participants' schools and houses:
~Reduce particle infiltration into residences by keeping windows and doors closed as much as possible and
~Reduce indoor particle levels by using air cleaners."
15919182|NCT03503812|Behavioral|Intervention (1) for outdoor exposure reduction - Atrial Fibrillation|"Intervention 1 (I1) aims to reduce exposure to outdoor particles and it will be applied on days with DDS during the 4-month period. This intervention will consist of two recommendations:
~Reduce time spent outdoors and
~Reduce physical activity"
15919183|NCT03503812|Behavioral|Intervention (2) for outdoor and indoor exposure reduction - Atrial Fibrillation|"Intervention 2 (I2) aims to reduce both:
~i) exposure to outdoor particles and it will be applied on days with DDS during the 4-month period. This intervention will consist of two recommendations:
~Reduce time spent outdoors and
~Reduce physical activity
~ii) indoor particle levels on a continuous daily basis throughout the 4-month DDS period. This intervention will consist of two recommendations for participants' houses:
~Reduce particle infiltration into residences by keeping windows and doors closed as much as possible and
~Reduce indoor particle levels by using air cleaners."
15919184|NCT03503799|Other|Observation|"Visit 1 Informed consent Medical history Demographics Result of EndoPredict® Test Status of menopause Disease status Tumor board decision Planned anti-tumor-therapy
~Visit 2, 1 year after inclusion This visit will be documented at the study site Status of menopause Disease status Anti-tumor therapy Survival
~Following visits For these visits, patients will be asked directly through the Center for Clinical Trials of the Philipps-University Marburg (KKS Marburg) via phone.
~Status of Menopause Disease status Anti-tumor therapy Survival
~Treatment after end of the study The patient will be treated during and after end of study by physician's choice."
15919185|NCT03503786|Drug|Carboplatin|Carboplatin AUC 5 i.v. every 3 weeks for 6 - 8 cycles
15919186|NCT03503786|Drug|Paclitaxel|Paclitaxel 175 mg/m2 i.v. every 3 weeks for 6-8 cycles
15919187|NCT03503786|Drug|Avelumab|Avelumab 10 mg/kg every 3 weeks for 6-8 cycles + Avelumab 10 mg/kg every 14 days until disease progression or unacceptable toxicity
15919188|NCT03503773|Drug|Alcohol|Alcohol is directly infused/delivered to the adventitial and periadventitial space of the renal arteries
15919189|NCT03503773|Other|Sham control|endovascular, renal angiography
15919190|NCT03503760|Device|LIMFA Therapy®|It applies a packages of magneto-electric field sequences having variable geometry, with frequencies and intensities that vary in a range of 0-80 Hertz and 0-100 microTesla, respectively.
15919233|NCT03503435|Behavioral|Group art therapy|Participants will undergo 6 weeks of group art therapy in which they will learn tools to cope with a variety of cognitive, emotional and social aspects of life after TL.
15919355|NCT03502655|Other|Placebo Comparator: Control message (second phase)|Effect of usual communication on pain during intravenous cannulation in an emergency department delivered by a care provider
15919191|NCT03503734|Behavioral|Integrated headache care|"The treatment can be realized on an inpatient, outpatient and/or day care basis, according to the severity level of illness and comorbidities.
~The inpatient treatment takes place at the Department of Internal and Integrative Medicine. The stay is slated for 14 days.
~Day care can follow the inpatient stay or can be applied as sole therapy. As part of the standard care provided at the Department for Internal and Integrative Medicine, it occurs at a semi-residential clinic for 6 hours once a week over a total of 10 weeks.
~The outpatient treatment is delivered in the Department's outpatient ward. It consists of acupuncture, cupping, hydrotherapy and massages as well as nutritional counseling. The patients can additionally be offered one-to-one mind-body-medicine interventions."
15919192|NCT03503721|Procedure|BipolEP|the prostate will be transurethrally enucleated using a bipolar current
15919193|NCT03503721|Procedure|bipolarTURP|the prostate will transurethrally resected using a bipolar current
15919194|NCT03503708|Drug|Livitol-70|Livitol-17 detoxifies, purifies and rejuvenates liver, kidney and spleen. Participants will be given the intervention in two bottles at each visit. Participant will be instructed to take two capsule twice daily at a fixed time in the day.
15919195|NCT03503695|Device|Sterile acupuncture semi-permanent (ASP) gold needles|
15919196|NCT03503682|Radiation|standard treatment|3000 cGy in 10 daily fractions
15919197|NCT03503682|Radiation|short course treatment|2000 cGy in 4 fractions administered twice a day
15919198|NCT03503669|Behavioral|Memory Training|Participants will attend a weekly memory training class for 12 weeks as well as receive daily memory homework (12 minute duration) for the 12 weeks.
15919199|NCT03503669|Behavioral|Kundalini yoga and meditation|Participants will participate in a 60 minute yoga and meditation session weekly for 12 weeks and will be assigned a daily Kirtan Kriya meditation (12 minute duration) for 12 weeks.
15919200|NCT03503656|Device|epidural catheter placement|insertion of an epidural catheter using Compuflo System
15919201|NCT03503643|Device|Hemigland Cryoablation|Hemigland cryoablation for the treatment of prostate cancer
15919202|NCT03503630|Drug|COMPOUND 2055269|COMPOUND 2055269 to be given every 2 weeks with chemotherapy for 6 cycles
15919203|NCT03503630|Radiation|Radiation Therapy|Radiotherapy 25 Gy to be given on Days 1-5
15919204|NCT03503630|Drug|mFOLFOX|Given every 2 weeks for 6 cycles
15919205|NCT03503630|Procedure|Total Mesorectal Excision|Surgery to be done 2-3 weeks after last cycle of chemotherapy and COMPOUND 2055269
15919206|NCT03503617|Device|RehabTouch|Exercise using the motion sensing devices and a computer
15919207|NCT03503617|Other|Conventional tabletop exercise program|Exercise following printed sheets of exercises
15919208|NCT03503604|Biological|hPV19 mAb|Intravenous (IV) infusions, 4 and 6 milligrams per kilogram (mg/kg) every 2 weeks
15919209|NCT03503604|Biological|hPV19 mAb|Intravenous (IV) infusions, 6 milligrams per kilogram (mg/kg) every 3 weeks
15919210|NCT03503604|Drug|5-Fluorouracil|400 mg/m2 bolus followed by a 2400 mg/m2 continuous infusion, every 2 weeks
15919211|NCT03503604|Drug|Oxaliplatin|IV Infusion, 85 milligrams per square meter (mg/m2) every 2 weeks
15919212|NCT03503604|Drug|Leucovorin|IV infusion, 400 mg/m2 every 2 weeks
15919213|NCT03503604|Drug|Paclitaxel|IV infusion, 175 mg/m2 every 3 weeks
15919214|NCT03503604|Drug|Carboplatin|IV infusion, AUC=6 every 3 weeks
15919215|NCT03503604|Drug|Gemcitabine|IV infusion, 1000 mg/m2 at day1 and day 8 every 3 weeks
15919216|NCT03503604|Drug|Carboplatin|IV infusion, AUC=4 every 3 weeks
15919217|NCT03503604|Drug|Irinotecan|IV Infusion,180 milligrams per square meter (mg/m2) every 2 weeks
15919218|NCT03503591|Device|Hummingbird Tympanostomy Tube System|Insertion of a ventilation tube under sedation and local anesthetic
15919219|NCT03503578|Drug|Sevoflurane|Subjects will received sevoflurane for approximately 60 minutes.
15919220|NCT03503578|Drug|Ketamine|Subjects will received sevoflurane and ketamine for approximately 60 minutes.
15919221|NCT03503565|Procedure|intraoperative neuromuscular blockade|The intensity of intraoperative neuromuscular blockade
15919222|NCT03503539|Procedure|Mini percutaneous nephrolithotomy|
15919223|NCT03503539|Procedure|Retrograde intrarenal surgery|
15919224|NCT03503526|Behavioral|Receptive music therapy|12 weekly trauma-focused Group therapy sessions of a length of 2.5 hours. The core element is receptive music psychotherapy with music listening, art making, and other art based methods.
15919225|NCT03503513|Drug|Gentamicin Sulfate|Gentamicin will be compounded by the Michigan Medicine Research Pharmacy in a concentration of 480 milligrams of the active product to 1000 milliliters of normal saline. Participants will do daily instillations of 30 milliliters of solution
15919226|NCT03503500|Other|Laid-back breastfeeding|"At randomization the Italian version of the video Biological nurturing, which provides detailed information on LB BF, will be delivered to women with the recommendation to watch it before birth; during the maternity ward stay, adequately trained staff will support women to breastfed in relaxed, laid-back position, with her baby laying prone on her, so that the baby's body is in the largest possible contact with mother's curves. In the maternity ward a daily supervision by an external expert on LB BF will be provided"
15919227|NCT03503500|Other|Standard care|"2. the standard care in use at the Institute (WHO/UNICEF 20-hours course) (control group). At randomization, the Italian version of the video Breast is best (Allattare informati), which provides detailed information on standard support to breastfeeding, will be delivered to women with the recommendation to watch it before birth; during the maternity ward stay, the staff will show to mothers how to breastfeed and will help them to attach the baby correctly to the breast"
15919228|NCT03503487|Other|3D informed consent|Patients were given an informed consent with the aid of a 3D immersive surgical planner (either a Surgical Theater or Vesalius)
15919229|NCT03503474|Other|No intervention|There is no intervention, this is observational only
15919230|NCT03503461|Other|exosomes analysis|Perform exosomes analysis in urine sample obtain from usual urine testing in both kidney transplant and control group.
15919231|NCT03503448|Procedure|Osteotomy between the maxillary central incisors|Surgically Assisted Rapid Maxillary Expansion with osteotomy between the central incisors.
15919232|NCT03503448|Procedure|Osteotomy between the maxillary lateral incisors and canines|Surgically Assisted Rapid Maxillary Expansion with bilateral osteotomy between the lateral incisors and canines
15919438|NCT03502070|Drug|Placebo|One dose (4 capsules) of placebo
15919234|NCT03503422|Procedure|Real transcranial direct current stimulation + therapeutic exercises for back pain|"Real transcranial direct current stimulation associated with therapeutic exercises for back pain
~tDCS: 20 minutes, 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion).Technique based on the application of weak, direct electrical current to the brain through relatively large electrodes that are placed over the scalp, in which anodal and cathodal stimulation increases and decreases cortical excitability, respectively."
15919235|NCT03503422|Procedure|Sham transcranial direct current stimulation + therapeutic exercises for back pain|"Sham transcranial direct current stimulation associated with therapeutic exercises for back pain.
~tDCS: 20 minutes (30 seconds ON), 2mA, primary motor cortex anode (contralateral to the lesion) and supraorbital cathode (ipsilateral to the lesion). Technique based on the application of weak, direct electrical current to the brain through relatively large electrodes that are placed over the scalp, in which anodal and cathodal stimulation increases and decreases cortical excitability, respectively"
15919236|NCT03503409|Drug|AG-120|500 mg/day Oral of AG-120. AG-120 will be dispensed on Day 1 of each treatment cycle
15919237|NCT03503396|Behavioral|BAC Driving Feedback/Warning|Participants will receive a warning at a set BAC limit, indicating they are too impaired to drive.
15919238|NCT03503396|Behavioral|No Feedback|Participants will receive no information about BAC, but will still complete study assessments and provide breath samples during drinking sessions.
15919239|NCT03503383|Behavioral|Patient Health Questionnaire-9|PHQ-9 for assessing and monitoring depression severity
15919240|NCT03503383|Behavioral|Generalized Anxiety Disorder Scale (GAD-7)|to diagnose generalized anxiety disorder, the GAD-7 also proved to have good sensitivity and specificity as a screener for panic, social anxiety, and post-traumatic stress disorder
15919241|NCT03503370|Drug|Chlorhexidine|Participants randomized to the intervention will wash their feet using 2% CHLORHEXIDINE GLUCONATE CLOTHS to wipe down their feet each day and then apply supplied chlorhexidine-compatible over-the-counter moisturizer.
15919242|NCT03503357|Other|IFT Testing1|Command List A
15919243|NCT03503357|Other|IFT Testing 2|Command List B
15919244|NCT03503357|Other|IFT Testing 3|Command List C
15919245|NCT03503357|Other|IFT Testing 4|Command List D
15919246|NCT03503344|Drug|Apalutamide|Given PO, 240 mg per day (4 x 60mg tablets)
15919247|NCT03503344|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15919248|NCT03503331|Drug|[C-11]PiB-PET/MRI|All study participants will undergo brain imaging with [C-11]PiB-PET/MRI. [C-11]PiB is a PET imaging agent used primarily to measure the amount of abnormal protein (called beta-amyloid) in the brain. The investigator will also use this tracer to evaluate regional cerebral blood flow.
15919249|NCT03503318|Drug|TV-46000|TV-46000 will be administered per dose and schedule specified in the arm.
15919250|NCT03503318|Drug|Placebo|Placebo matching to TV-46000 will be administered per schedule specified in the arm.
15919251|NCT03503305|Device|adipose-derived stem cell injection|5 ml injection of adipose derived stem cells
15919252|NCT03503305|Drug|Corticosteroid injection|5 ml injection of corticosteroid
15919253|NCT03503292|Drug|Granisetron|Rapid metabolizer will receive 1mg IV Granisetron
15919254|NCT03503292|Drug|Ondansetron|Poor or normal metabolizers will receive 4mg Ondansetron IV
15919255|NCT03503279|Device|McGrath MAC® Video Laryngoscope|McGrath MAC® Video Laryngoscope have been developed to secure the airway and improve the management of difficult intubation. McGrath MAC® is a self-contained VL with a single-use blade; its structure is similar to the ML, but without the channel that guides the tube and a mounted LCD screen on the handle that is connected to a miniature camera with a light source at the tip of the blade, allowing the clinicians to directly observe surrounding anatomical airway structures during a tracheal intubation
15919256|NCT03503266|Drug|[14C] MT-7117|14-C MT-7117
15919257|NCT03503253|Device|Interlock-35 Fibered IDC Occlusion System|Use of detachable coil for LAA leak closure
15919258|NCT03503253|Device|Concerto Helix Detachable Coil System|Use of detachable coil for LAA leak closure
15919259|NCT03503253|Device|Azur Peripheral Coil System|Use of detachable coil for LAA leak closure
15919260|NCT03503227|Drug|prednisolone|daily oral low dose prednisolone (10 mg/day) :a glucocorticoid
15919261|NCT03503227|Drug|Acetyl Salicylic acid|daily oral low dose Acetylsalicylic acid (75 mg) : Antiplatelet agent
15919262|NCT03503214|Diagnostic Test|In vitro determination of non-carbonic buffer power|In vitro measurement of the non-carbonic buffer power by the means of equilibration of whole blood and isolated plasma with gas mixtures containing different concentrations of carbon dioxide
15919263|NCT03503214|Diagnostic Test|Classic description of acid-base status|Measurement of plasma electrolytes, hemoglobin concentration, albumin and phosphates to compute acid-base variables according to Stewart's approach.
15919264|NCT03503201|Dietary Supplement|Chromium|chromium supplementation as capsules of 200 micrograms of chromium picolinte (Arab company for pharmaceuticals and medicinal plants) daily for 2 months before ICSI cycle
15919265|NCT03503188|Device|Littmann ®|electronic stethoscope
15919266|NCT03503175|Device|Novel urinary access system (CystoSureTM)|CystoSureTM is a silicone device that was developed by surgeons to enable easy and standardized cystoscopy. The design of the CystoSureTM catheter has separate channels for draining the bladder and performing cystoscopy, so doctors can perform a cystoscopy without removing the catheter (which can, as described above, potentially lead to a UTI).
15919267|NCT03503175|Device|Standard Foley catheter|Participants randomized to this arm will receive a standard Foley catheter and standard rigid cystoscopy.
15919268|NCT03503162|Device|Pure-Vu System|The Pure-Vu System is FDA cleared device and CE marking received in February 2018, intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and other bodily fluids and matter, e.g. blood.
15919269|NCT03503149|Other|no intervention|observational study
15919270|NCT03503136|Drug|docetaxel, nedaplatin, and capecitabine|Patients receive docetaxel(60 mg/m2 on day 1), nedaplatin (60 mg/m2 on day 1) and capecitabine (625 mg/m2 bid, on Days 1 to 14) every three weeks for three cycles before the radiotherapy.
15919271|NCT03503136|Drug|nedaplatin|Patients receive concurrent nedaplatin (100mg/m2) every three weeks for two cycles during radiotherapy.
15948773|NCT03273842|Biological|PF-06881894|pre-filled syringe 6 mg
15919272|NCT03503136|Drug|docetaxel, cisplatin, and fluorouracil|Patients receive docetaxel (60mg/m2 on day 1), cisplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy.
15919273|NCT03503136|Drug|cisplatin|Patients receive concurrent cisplatin (100mg/m2) every three weeks for two cycles during radiotherapy.
15919274|NCT03503136|Drug|docetaxel, cisplatin, and capecitabine|Patients receive docetaxel(60 mg/m2 on day 1), cisplatin (60 mg/m2 on day 1) and capecitabine (625 mg/m2 bid, on Days 1 to 14) every three weeks for three cycles before the radiotherapy.
15919275|NCT03503136|Drug|docetaxel, nedaplatin, and fluorouracil|Patients receive docetaxel (60mg/m2 on day 1), nedaplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy.
15919276|NCT03503123|Device|Monitoring physiology with Electrical Impedance Tomography, Electromyography and transcutaneous carbon dioxide measurements.|Both groups get the same exposures: with measure physiology in both groups by using non-invasive measurement techniques. The techniques we use are Electrical Impedance Tomography to determine degree of hyperinflation. We use Electromyography to analyse respiratory drive. We measure transcutaneous carbon dioxide to assess the effects of non-invasive ventilation. Thereby, we will perform lung function tests.
15919277|NCT03503110|Other|electrocorticography with electrostimulation|The investigators aim to establish a relationship between dMRI SC measures, direct measures of electrical properties of the human brain cortex obtained with electrocorticography (ECoG), and response elicited by direct electrostimulation of the brain (DES)
15919278|NCT03503110|Other|dRMI|The investigators aim to establish a relationship between dMRI SC measures, direct measures of electrical properties of the human brain cortex obtained with electrocorticography (ECoG), and response elicited by direct electrostimulation of the brain (DES)
15919279|NCT03503097|Procedure|Biospecimen Collection|Provide saliva samples
15919280|NCT03503097|Other|Genetic Counseling|Undergo counseling
15919281|NCT03503097|Other|Genetic Testing|Undergo genetic testing
15919282|NCT03503097|Other|Laboratory Biomarker Analysis|Correlative studies
15919283|NCT03503097|Behavioral|Questionnaire|Complete questionnaire
15919284|NCT03503084|Behavioral|Classical Yang's TCC exercise|
15919285|NCT03503071|Procedure|Cytoreductive surgery and intraperitoneal chemotherapy|Cytoreductive surgery and intraperitoneal chemotherapy for colorectal cancer or pseudomyxoma peritonei. Either early postoperative intraperitoneal chemotherapy (EPIC) or hyperthermic intraperitoneal chemotherapy (HIPEC) is used for intraperitoneal chemotherapy.
15919286|NCT03503058|Biological|PfSPZ Vaccine|Radiation-attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ Vaccine)
15919287|NCT03503058|Biological|PfSPZ Challenge under chloroquine (CQ) chemoprophylaxis|Infectious, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ Challenge) administered under CQ chemoprophylaxis
15919288|NCT03503058|Other|Normal Saline|0.9% Sodium chloride
15919289|NCT03503032|Procedure|Extracardiac Fontan|Extracardiac Fontan (Total cavo-pulmonary connection) will be constructed with a tube graft from the inferior vena cava to the pulmonary artery [applied to both arms]
15919290|NCT03503032|Procedure|Fontan fenestration|Fontan fenestration created as a single 3 to 6mm communication between fontan channel and pulmonary venous atrium [Fenestrated arm]
15919291|NCT03502993|Diagnostic Test|Validation of biomarker|
15919292|NCT03502993|Other|Antibiotic prescription|
15919293|NCT03502993|Other|re-attendance at ED|
15919294|NCT03502993|Other|Hospitalisation|
15919295|NCT03502980|Device|Bard PowerPICC|PICC Insertion
15919296|NCT03502980|Device|Bard PowerMidline catheter|Midline Insertion
15919297|NCT03502967|Drug|Hyperpolarized [1-13C] Pyruvate|Bolus injection of study drug
15919298|NCT03502967|Drug|Hyperpolarized [2-13C] Pyruvate|Bolus injection of study drug
15919299|NCT03502954|Biological|ABY-039|ABY-039
15919300|NCT03502954|Biological|Placebo|Placebo
15919301|NCT03502941|Dietary Supplement|6.3 g of EAAs mixture and whey protein isolate|A single dose of the mixture of EAAs/whey
15919302|NCT03502941|Dietary Supplement|12.6 g of EAAs mixture and whey protein isolate|A double dose of the mixture of EAAs/whey
15919303|NCT03502941|Dietary Supplement|12.6 g of whey protein isolate|Whey protein isolate alone, which is an equal amount to the double dose of the mixture of EAAs/whey
15919304|NCT03502928|Other|Motor Control|Neck Motor Control
15919305|NCT03502928|Other|Manual Therapy|Massage + Joint Mobilizations
15919306|NCT03502928|Other|Dry Needling|Dry Needling in Neck Muscles
15919307|NCT03502915|Drug|Nitrous Oxide|50% nitrous oxide/50% oxygen via Nitronox delivery device
15919308|NCT03502915|Other|Placebo|100% oxygen via Nitronox delivery device
15919309|NCT03502902|Drug|HEC 68498|HEC68498 is a potent,highly selective inhibitor of class 1 isozymes of phosphoinositide 3-kinase/mammalian(PI3K) and of the mammalian target of rapamycin (mTOR). It has shown good activity against fibrosis and inflammation in vitro and in vivo, with a lower effective dose and better efficacy than pirfenidone and nintedanib.
15919310|NCT03502902|Drug|Placebo|Placebo
15919311|NCT03502889|Procedure|SPANK Block (Sensory Posterior Articular Nerves of the Knee)|Injection of local anesthetic into the tissues on the posterior aspect of the knee to provide sensory blockade of the articular nerves of the knee.
15919312|NCT03502889|Procedure|Adductor Canal Block|Injection of local anesthetic into the inner thigh under ultrasound guidance to provide sensory blockade to the anterior aspect of the knee
15919313|NCT03502889|Drug|Ropivacaine Hcl 0.5% Inj Vil 30Ml|Amide local anesthetic, this concentration is commonly used to achieve surgical level anesthesia. The drug itself is not being studied and the same concentration will be used in all participants.
15919314|NCT03502889|Device|Pajunk sonoplex stim needle|Echogenic needle used for ultrasound guided nerve blockade.
15919315|NCT03502863|Device|Digital refraction|A web-based application for obtaining the refractive error and visual acuity of each eye, using a computer and a smart phone.
15919316|NCT03502863|Other|Manual Refraction|Manual refraction and ETDRS chart
15919317|NCT03502850|Drug|ASK120067|patients take ASK120067 orally once per day at 40,80,160,240,320,480mg
15919354|NCT03502655|Other|Experimental: Intervention message (second phase)|Effect of positive communication on pain during intravenous cannulation in an emergency department delivered by a care provider
15919318|NCT03502837|Other|emotional sound and neutral sound|"Neutral voice is a meaningless sound (namely the interjection ah) and the emotional stimuli were the same voice pronouncing the same word with an emotional prosody of happiness or sadness.The stimulus material consisted of positive and negative sound selected from the International Affective Digitalized Sounds (IADS) database.In order to identify experimental stimuli sets that were matched for ratings of arousal and valence between the two valence types,investigators used an algorithm to equate normative valence and arousal ratings for the selection of auditory stimuli."
15919319|NCT03502824|Device|PuraPly® Antimicrobial Wound Matrix|PuraPly® AM is a class II medical device, that has been 510(k) cleared by US Food and Drug Administration (FDA) (K051647) and is intended for the management of acute and chronic wound management across a variety of wound types, including partial- and full-thickness wounds, pressure ulcers, surgical wounds, trauma wounds, venous and diabetic ulcers.
15919320|NCT03502824|Other|SOC for Pressure Ulcers|SOC group will receive institutional standard of care which includes, but is not limited to, debridement, negative pressure wound therapy (i.e. VAC), ensuring perfusion and oxygenation, evaluating nutritional status and addressing deficits, offloading, keeping the ulcer bed moist with appropriate cleansing at the time of each dressing change. Standard dressings may include hydrocolloids, alginates, transparent film, foam, moist gauze dressings. In addition, a non-toxic topical antiseptic, may be used per NPUAP Clinical Practice Guidelines (2014) for SOC group only, if colonization is suspected.
15919321|NCT03502811|Device|MitraClip NTR/XTR System|Percutaneous mitral valve repair using the MitraClip NTR/XTR system.
15919322|NCT03502798|Device|scanning a/LCI|Imaging of the cervical epithelium using the scanning a/LCI device.
15919323|NCT03502785|Biological|INO-5401|INO-5401 (9 milligram [mg] dose IM): mixture of 3 synthetic plasmids that target Wilms' tumor gene-1 (WT1) antigen, prostate-specific membrane antigen (PSMA) and human telomerase reverse transcriptase (hTERT) antigen.
15919324|NCT03502785|Biological|INO-9012|"INO-9012 (1 mg dose IM): A synthetic plasmid that expresses human interleukin-12 (IL-12).
~INO-5401 + INO-9012 will be administered IM followed by EP with CELLECTRA™ 2000 device every 3 weeks for 4 doses then every 6 weeks for 6 additional doses, thereafter every 12 weeks until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator."
15919325|NCT03502785|Drug|Atezolizumab|Atezolizumab will be administered by intravenous (IV) infusion every 3 weeks until confirmed disease progression, unacceptable toxicity, or deemed intolerable by the investigator.
15919326|NCT03502785|Device|CELLECTRA™ 2000|IM injection of INO-5401 and INO-9012 is followed by EP with the CELLECTRA™ 2000 device.
15919327|NCT03502772|Other|Pilates exercises|Clinical Pilates training program will be given one session in a week for 8 weeks plus two days home exercise program. Group exercise sessions will be performed. The sessions will be supervised by a physiotherapist who is certified.
15919328|NCT03502772|Other|Home exercise program|written exercises that matched the aims of the Pilates exercises, 3 times per week for 8 weeks. These exercises reflect routine clinical practice (flexibility, strength, and balance exercises).
15919329|NCT03502759|Behavioral|CHICA SUDEP module|CHICA reminds physicians to counsel patients/families about the risk of SUDEP.
15919330|NCT03502746|Drug|Nivolumab|Nivolumab 240mg, IV over 30 minutes.
15919331|NCT03502746|Drug|Ramucirumab|8mg/kg, IV over 60 minutes.
15919332|NCT03502733|Drug|Copanlisib|Given IV
15919333|NCT03502733|Biological|Ipilimumab|Given IV
15919334|NCT03502733|Biological|Nivolumab|Given IV
15919335|NCT03502720|Device|Scaphoid fixation using 3D device|A headless screw inserted percutaneously from the volar aspect of the scaphoid in a retrograde manner using a customised 3D exoesqueleton guide
15919336|NCT03502720|Procedure|Scaphoid fixation using standard procedure|A headless screw inserted percutaneously from the volar aspect of the scaphoid in a retrograde manner without using the 3D device (standard procedure)
15919346|NCT03502694|Drug|Lumicitabine|Participants will receive loading dose and maintenance dose of lumicitabine tablets orally.
15919347|NCT03502694|Drug|Placebo|Participants will receive matching placebo tablets orally.
15919348|NCT03502681|Drug|Eribulin Mesylate|"Days 1, 15
~Eribulin mesylate:
~Dose level -1: 0.7mg/m^2;
~Dose level 0: 1.1 mg/m^2;
~Dose level +1: 1.4 mg/m^2"
15919349|NCT03502681|Drug|Avelumab|Days 1, 15 Avelumab (10mg/kg)
15919350|NCT03502668|Drug|ASTX727 LD|oral decitabine (LD) + cedazuridine (E7727)
15919351|NCT03502668|Drug|ASTX727 SD|oral decitabine (SD) + cedazuridine (E7727)
15919352|NCT03502655|Other|Experimental: Intervention message (first phase)|Effect of positive communication on pain during intravenous cannulation in an emergency department delivered by a recorded message
15919353|NCT03502655|Other|Placebo Comparator: Control message (first phase)|Effect of usual communication on pain during intravenous cannulation in an emergency department delivered by a recorded message
15919356|NCT03502642|Device|wound infusion (Dosi-Pain® Kit, LEVENTON SAU, Spain)|After peritoneum closure a 16cm multiorifice perforated catheter (Dosi-Pain® Kit, LEVENTON SAU, Spain) was inserted by the surgeon below the fascia used for normal saline continuous infusion in the Placebo group and for continuous ropivacaine infusion (Ropivacaina Molteni®, MOLTENI FARMACEUTICI, Italy) in the ropivacaine group.
15919357|NCT03502642|Procedure|Spinal Anesthesia|Cesarean section was conducted under spinal anesthesia in both groups
15919358|NCT03502642|Drug|intrathecal morphine|Intrathecal morphine was administered during spinal anesthesia in the placebo group but not in the ropivacaine group
15919359|NCT03502642|Drug|Ropivacaine (Ropivacaina Molteni®)|A10ml bolus of ropivacaine 7.5mg/ml were administered in the wound catheter after skin closure then an infusion of ropivacaine 2mg/ml at the rate of 5ml/h was administered as wound infusion via the Dosi-Pain® Kit for 48hours.
15919360|NCT03502642|Drug|Normal saline|A10ml bolus of normal saline were administered in the wound catheter after skin closure then an infusion of normal saline at the rate of 5ml/h was administered as wound infusion via the Dosi-Pain® Kit for 48hours.
15919361|NCT03502629|Biological|GB226|3mg/kg treat every 2 weeks
15919362|NCT03502616|Drug|Tofacitinib|Oral administration twice per day
15919363|NCT03502603|Diagnostic Test|Railroad Test|This is a test designed to evaluate visual perception capacities and requires the participant to match photographs with railroads as a central theme. The participant is presented with a photograph image at the top of the screen and is asked to match it to one of the two, three or four choices in the lower portion of the display.
15919364|NCT03502603|Diagnostic Test|Swamp Test|This is a test of immediate visual memory/attention for photographs with swamp wetlands as a central theme. The participant is briefly presented with a photograph which is replaced by two, three or four choices, one of which the participant is asked to select as the initially presented image.
15919365|NCT03502603|Diagnostic Test|Presidents Recognition Test|This is a test of history knowledge and facial recognition using pictures of US presidents and non-president distractors. The participant is presented with two photographs and is asked to identify which is the picture of a US president
15919366|NCT03502603|Diagnostic Test|Judgment of Line Orientation|This test requires participants to visually match the orientation of line segments. This is a test of visual perception and was included as a relative equivalent of the Railroad Test.
15919367|NCT03502603|Diagnostic Test|Symbol Span subtest of the Wechsler Memory Scale-IV|This test requires participants to immediately recall a sequence of designs after a brief presentation. This is a test of immediate visual memory/attention and was included as a relative equivalent of the Swamp Test
15919368|NCT03502603|Diagnostic Test|Information subtest of the Wechsler Adult Intelligence Scale-IV:|This test requires participants to answer factual knowledge questions. This is a test of fund of knowledge and was included as a verbal equivalent for the non-verbal Presidents Recognition Test.
15919369|NCT03502603|Diagnostic Test|Digit Span subtest of the Wechsler Adult Intelligence Scale-I|This test requires the participant to repeat sets of digits forward, backward, and to sequence digits in ascending order. This is a test of immediate memory/attention and was included to investigate possible attentional correlates of the Swamp Test. This test includes a performance validity indicator that will permit analyses of validity indicators included with the experimental tests
15919370|NCT03502603|Diagnostic Test|Reading subtest of the Wide Range Achievement Test|This test requires participants to read words printed on a card. This is a test of word knowledge/academic achievement and was included to investigate the academic achievement concomitants of the Presidents Recognition Test.
15919371|NCT03502603|Diagnostic Test|Symbol Digit Modalities Test:|This test requires participants to visually match abstract symbols with numbers within a certain time period. The participant either verbalizes or writes the response on an answer sheet. This is a test of speed of information processing and was included to assess speed of response factors pertaining to all of the experimental tests as reflecting speed of information processing.
15919372|NCT03502603|Diagnostic Test|Dot Counting Test|This test requires participants to count arrays of dots presented on a card while being timed. This is a performance validity test and was included to ascertain validity factors pertaining to each of the experimental tests.
15919373|NCT03502590|Device|IGEL Laryngeal mask|Insertion of an IGEL device in anaesthetised patients
15919374|NCT03502577|Biological|BCMA-specific CAR-expressing T Lymphocytes|Receive CAR T infusion
15919375|NCT03502577|Drug|Cyclophosphamide|Given IV
15919376|NCT03502577|Drug|Fludarabine|Given IV
15919377|NCT03502577|Drug|Gamma-Secretase Inhibitor LY3039478|Given PO
15919378|NCT03502577|Other|Laboratory Biomarker Analysis|Correlative studies
15919379|NCT03502577|Other|Pharmacokinetic Study|Correlative studies
15919380|NCT03502564|Behavioral|CBT for ED|Cognitive behavior therapy (CBT) for eating disorders (ED) is a 16-session individual therapy protocol which will focus on maintaining improvements in eating following intensive treatment, as well as addressing overconcern with weight/shape. Interventions will be adopted from the Enhanced CBT for ED manual.
15919381|NCT03502564|Behavioral|Concurrent CBT for ED and PTSD|The concurrent ED and PTSD intervention will consist of 16 sessions of CBT for both PTSD and for ED (ED interventions described above). CBT for PTSD will be based on interventions in the Cognitive Processing Therapy (CPT) manual.
15919382|NCT03502551|Drug|Ketamine|Ketamine infusion (0.5 mg/kg) over 40 minutes.
15919383|NCT03502538|Device|Curaprox 5460 Ultra Soft|The toothbrush Curaprox 5460 Ultra Soft will be the tested toothbrush model, in order to asses its efficacy in plaque removal. Therefore, the study participants should brush their teeth using this toothbrush model, following the instructions of the investigator. From the data collect related in plaque removal the results will be arrived at.
15919384|NCT03502538|Device|Oral-B Indicator Plus|Following the same method of the Curaprox group intervention, the participants should brush their teeth using the Oral-B Indicator Plus toothbrush and based on the data collect, the results will be compared with the first group of intervention.
15919439|NCT03502070|Device|Tobi Podhaler|The placebo capsule has to be released from the blister card and inserted into the Podhaler device. The device is then actuated and the study drug is inhaled according to the instructions for use
15919440|NCT03502044|Device|Inactive Kinetic Oscillation Stimulation (KOS)|10 minutes inactive KOS treatment in each nasal cavity.
15919441|NCT03502044|Device|Active Kinetic Oscillation Stimulation (KOS)|10 minutes active KOS treatment in each nasal cavity.
15919385|NCT03502525|Behavioral|Break the Cycle Intervention|The intervention uses motivational interviewing to enhance persons who inject drugs' (PWID) motivation and skills to avoid helping non-PWID transition to injecting. The intervention entails discussions with participants in 8 areas: the participant's first time injecting; the participant's exposures to situations where helping with non-PWIDs' first injections is an option, and the extent to which they helped; their behaviors that might encourage non-PWID to inject for the first time; the risks associated with injection drug use; role-playing in which participants develop behaviors and scripts for avoiding or refusing requests to initiate non-PWID into injection; role- playing talking with other PWID about not encouraging non-PWID to start injecting; imparting safer injection practices when helping with a first injection seems like the best option; and receiving training in and using naloxone to reverse overdoses.
15919386|NCT03502512|Other|Questionnaire Administration|Ancillary studies
15919387|NCT03502512|Procedure|Reconstructive Surgery|Undergo reconstructive surgery with REVOLVE technique
15919388|NCT03502512|Procedure|Reconstructive Surgery|Undergo reconstructive surgery with PureGraft technique
15919389|NCT03502499|Drug|Half-normal saline|Use of half-normal saline as an irrigant for open-irrigated ablation catheters
15919390|NCT03502499|Drug|Normal saline|Use of normal saline as an irrigant for open-irrigated ablation catheters
15919391|NCT03502486|Other|Moderate exercise|20 minutes of cycle ergometry at 50-60% of heart rate max
15919392|NCT03502486|Other|Intense exercise|20 minutes of cycle ergometry at 70-80% of heart rate max
15919393|NCT03502486|Other|Reading|20 minutes of seated reading
15919394|NCT03502473|Device|UltraShape Power device|"UltraShape Power is a non-invasive focused ultrasound device, approved by the FDA (160896K;170370K); CE; Israeli Ministry of Health. The UltraShape Power system works by emitting acoustic waves of focused ultrasonic energy (200 ± 30 KHz frequency) that converge into a confined focal volume underneath the skin, thereby, targeting only subcutaneous fat at a controlled depth. Unlike traditional ultrasound technology, UltraShape Power's energy transmits pulsed ultrasound, allowing control over temperature elevation. The system comprised of two main parts:
~The Main console
~Transducer"
15919395|NCT03502460|Other|Operating Room Fluid Administration Lung Ultrasound|Use of lung ultrasound to limited fluid administration
15919396|NCT03502447|Device|TearCare|TearCare treatment includes an in-office 15 minute thermal treatment session where heat is delivered to the eyelids. This is immediately followed by manual clearing of the meibomian glands.
15919397|NCT03502447|Device|Warm Compress and Lid Massage|Subjects randomized to the Warm Compress and Lid Massage Group will be instructed to apply a moist, warm compress to their eyelids daily for 5 minutes and then perform lid massage.
15919398|NCT03502434|Drug|SM04755|Healthcare professional-applied patches to subjects during the Induction Period on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19, and during the Challenge Period on Day 36. Patches are to be worn by the subject for approximately 48-72 hours before removal and reaction grading.
15919399|NCT03502434|Other|Vehicle|Healthcare professional-applied patches to subjects during the Induction Period on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19, and during the Challenge Period on Day 36. Patches are to be worn by the subject for approximately 48-72 hours before removal and reaction grading.
15919400|NCT03502434|Other|White Petrolatum|Healthcare professional-applied patches to subjects during the Induction Period on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19, and during the Challenge Period on Day 36. Patches are to be worn by the subject for approximately 48-72 hours before removal and reaction grading.
15919401|NCT03502434|Other|Sodium lauryl sulfate|Healthcare professional-applied patches to subjects during the Induction Period on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19, and during the Challenge Period on Day 36. Patches are to be worn by the subject for approximately 48-72 hours before removal and reaction grading.
15919402|NCT03502421|Drug|Ketamine|Low dose continuous infusion of ketamine 0.3 to 0.5 mg/kg per hour
15919403|NCT03502408|Procedure|Endovascular Thrombectomy|Procedure: Endovascular Thrombectomy Device: Trepo trevor Retriever Device: Solitaire™ FR Revascularization Device
15919404|NCT03502408|Procedure|Endovascular Thrombectomy|Procedure:Endovascular Thrombectomy Device: Solitaire™ FR Revascularization Device
15919405|NCT03502395|Drug|Lidocaine|): Patients were received intravenous 1 mg/kg of 2 % lidocaine as a loading dose (just before induction of anesthesia) then received 2mg/kg /h lidocaine as maintenance dose (with maximum of 200 mg/h) till the end of the operation (skin closure).
15919406|NCT03502395|Drug|Normal saline|A standardized equal volume of intravenous bolus dose of normal saline was given as loading dose then normal saline was administered on an equal rate of infusion.
15919407|NCT03502382|Diagnostic Test|x-ray|Radiological: standing antero-posterior full-length digital images of the lower extremities
15919408|NCT03502369|Procedure|Anterior Quadratus lamborum block|Local anaesthetic will be injected in the fascial plane between psoas major muscle and quadratus lumborum muscle.
15919409|NCT03502356|Drug|Azithromycin|In this group, patients will receive standard antibiotic prophylaxis CEFAZOLIN (at a dose of 1 g) and azithromycin (at a dose of 1g) 2 hours preoperative.
15919410|NCT03502343|Drug|Modified Gemcitabine plus nab-Paclitaxel Combination Chemotherapy|"All patients will receive slow (over 30-40 minutes) intravenous administration of nab-paclitaxel (125 mg/m2) on days 1 and 15, and gemcitabine (1000 mg/m2) on days 1, 8, and 15 of a 28- day cycle (every 4 weeks). Treatment will discontinue if disease progression or intolerable toxicity is observed, if the patient withdraws from the study, or at the physician's discretion.
~Dose reduction of the chemotherapeutic agent and/or delay of administration is allowed if serious treatment-related AEs occur, according to specified guideline in study protocol (Level 1: 100% -> 80%; Level 2: 80% -> 60%). If dose reduction is needed more than Level 2, the patient will be dropped from the trial."
15919411|NCT03502330|Drug|APX005M|APX005M is a humanized Immunoglobulin G (IgG) 1 agonistic monoclonal antibody that binds cluster of differentiation (CD) 40. APX005M is administered by intravenous infusion.
15919412|NCT03502330|Drug|Cabiralizumab|Cabiralizumab is a humanized Immunoglobulin G (IgG) 4 monoclonal antibody directed against Colony stimulating factor 1 receptor (CSF1R). Cabiralizumab is administered by intravenous infusion.
15919413|NCT03502330|Drug|Nivolumab|Nivolumab is a humanized IgG4 monoclonal antibody directed against programmed cell death 1 (PD-1). Nivolumab is administered by intravenous infusion.
15919442|NCT03502031|Drug|Renin-Angiotensin (RAAS) bers (ACE/ARB) alone|maximal RAAS blockade alone for 2months.
15919414|NCT03502317|Behavioral|Physical Prehabilitation|Physical prehabilitation will comprise a personalized, home-based exercise program designed to meet the Cancer Care Ontario Exercise Guidelines for Cancer Survivors. A Registered Kinesiologist (RKin) will complete a baseline physical assessment and prescribe an individualized multi-modal exercise program consisting of 4-5 days of 30+ minutes of aerobic exercise (brisk walking or equivalent to target heart rate of 40-60% of max) and 2-3 days of moderate intensity resistance training of major muscle groups (8-10 repetitions). Participants will be provided with a Fitbit with a heart rate monitor, resistance bands, and a stability ball. Patients will be required to wear their Fitbit and record the number of steps at the end of each day from randomization to 90 days post-surgery.
15919415|NCT03502317|Behavioral|Psychological Prehabilitation|Psychological prehabilitation will consist of one in-person coaching session of a 'mindfulness' informed intervention conducted by a specially trained RKin. The 40 minute coaching session will include a guided mindfulness session and debriefing. Participants will be asked to practice for 20 minutes twice a day. The patients will be given access to an audio file that will walk them through the 20 minute sessions.
15919416|NCT03502304|Behavioral|Endurance training plus resistant training|CT in women with prediabetes and co-morbidities associated. Exercise will be performed at three sessions per week. Post statistical analyses will be including analyses by the 2 groups proposed. All sessions will be supervised by an exercise physiologist during 20-weeks.
15919417|NCT03502291|Biological|Study one: LAIV + Inoculation|Pneumococci bacteria nasal inoculation following vaccination with LAIV and intramuscular placebo
15919418|NCT03502291|Biological|Study one: Placebo + Inoculation|Pneumococci bacteria nasal inoculation following vaccination QIV with nasal placebo spray
15919419|NCT03502291|Biological|Study two: Inoculation + LAIV|Pneumococci bacteria nasal inoculation prior to vaccination with LAIV and intramuscular placebo
15919420|NCT03502291|Biological|Study two: Inoculation + placebo|Pneumococci bacteria nasal inoculation prior to vaccination QIV with nasal placebo
15919421|NCT03502278|Behavioral|Islamic Trauma Healing|A lay-led, six-session group intervention that combines empirically supported exposure-based and cognitive restructuring techniques with Islamic principles
15919423|NCT03502252|Behavioral|Semillas de Apego|Group-based Primary Caregiver Intervention: Group-based psychosocial program for victimized mothers (or alternative primary caregivers) with children 2 to 5, that aims at promoting healthy child-parent attachments as a pathway for a proper development among children exposed to violence.
15919424|NCT03502239|Other|Mega Team - video game|Subjects randomly assigned to the treatment group will be instructed to practice Mega Team for 15 minutes a day, 5 days a week for a minimum of 21 days and a maximum of 25 days.
15919425|NCT03502226|Behavioral|Tailored feedback|"Electronic feedback based on participants stage of change which provided risk reduction behavior regarding their sexual health including use of condoms, contraceptions, and STI testing."
15919426|NCT03502187|Behavioral|Progressive Exercise Plan|The goal of PEP is to reduce back pain, disability, and improve trunk flexibility, strength and endurance through controlled, gradual, progressive back exercises. PEP teaches muscle strengthening exercises and self-management strategies to promote back fitness. PEP sessions provide a standardized self-management framework for performing the exercises at home. PEP is performed every other day/week for about ~1 hour over a period of 9 weeks. PEP consists of 3 sequential phases with each phase lasting 3 weeks. Exercises become progressively more difficult and intense, focusing on back stretching and strengthening that progressively load and unload the lumbar spine by means of flexion/extension exercises. The PEP group will perform 31 exercise sessions for 60 minutes on alternating days.
15919427|NCT03502187|Device|NeuromuscularElectricalStimulation(NMES)|The NMES treatment group will receive a portable battery-operated device, Recovery Back (Neurotech®, Minnetonka, MN) with a 2-garment site-specific system: back & abdomen. NMES muscle contractions will be elicited by an electrical impulse generated by the Recovery Back system. The device delivers a pre-set program of NMES using a symmetrical biphasic square pulse waveform. (Moore SR, Shurman J, 1997) The garments are light-weight, breathable fabric that wraps around the waist with precise placements for the reusable electrodes. The controller uses a rechargeable battery with charger supplied. The NMES protocol consists of 30-minutes of NMES stimulation alternating between the abdominal and lumbar site over 9-weeks (one day Back training, next day Abdominal training).
15919428|NCT03502187|Behavioral|Primary Care Management (PCM)|All participants will receive standard primary care management for subacute LBP. Primary Care Management follows the clinical practice guidelines for low back pain.(Chou et al., 2007) Service members are to stay as active as possible and progressively increase their activity. Medications prescribed begin with paracetamol and NSAIDs as first-line drugs. Second-line drugs include antidepressants, benzodiazepines, tramadol, and opioids. All participants will receive an information sheet on LBP advising them to remain active and use self-care options such as heat application. To provide an attention control, the PCM only group will receive weekly communication from the study coordinator regarding pain and medication usage.
15919429|NCT03502174|Device|FreeStyle Libre Flash Glucose Monitoring System|Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System and will receive no treatment except for safety purposes.
15919430|NCT03502161|Device|QuantiFERON CMV Assay|Assay to measure cell-mediated immune function using QuantiFERON CMV assay.
15919431|NCT03502148|Drug|PRV111 (Cisplatin Transmucosal System)|Each treatment visit will include one application of a permeation enhancer and then 2, 3 or 5 PRV111 (Cisplatin Transmucosal System) applications depending on the Stage subject is enrolled in.
15919432|NCT03502135|Drug|Tetracaine HCl and oxymetazoline HCl nasal spray|Two intranasal sprays of anesthetic. Each spray delivers 0.2 mL of solution containing 6 mg tetracaine hydrochloride and 0.1 mg of oxymetazoline hydrochloride
15919433|NCT03502122|Other|VR rehabilitation for motor function|rehabilitation for motor function
15919434|NCT03502109|Other|Medication review with follow-up|Medication review with follow-up: trained pharmacists will conduct consecutive medication reviews by detecting and resolving drug related problems, educational interventions and applying pharmacotherapy changes made in collaboration with physicians.
15919435|NCT03502096|Behavioral|To-Go container|Subjects were provided a to-go container in which leftover foods would be packaged
15919436|NCT03502096|Other|Control|Subjects were not provided a to-go container with the meal
15919437|NCT03502083|Drug|GLP-1 (7-36)Amide|IV infusion
15919443|NCT03502031|Drug|Renin-Angiotensin (RAAS) blockers in combination with Spironolactone|maximal RAAS blockade alone or in combination with Spironolactone (25 mg) for 1024 months.
15919444|NCT03502018|Drug|Bupivacaine liposome|A long-acting liposomal bupivacaine
15919445|NCT03502018|Drug|Saline|Saline injection used as control
15919446|NCT03502005|Drug|bictegravir/emtricitabine/tenofovir alafenamide|Discontinue ATRIPLA® and initiate BIKTARVY®
15919447|NCT03501992|Behavioral|Current care|The current care arm consists of the contemporary efforts now in practice to support provider recommendation including a shared, standard immunization schedule, a shared rooming process, a shared well child visit schedule, a shared electronic prompt at point-of-care of vaccines due.
15919448|NCT03501992|Behavioral|Reminder-recall|The communication will use expectant (announcement-style or presumptive) language noting the child's HPV vaccination status and stating that the child's provider strongly recommends the child receive the HPV vaccination now. The communication will also describe availability of topical anesthetics (less pain), indicate the availability and convenience of nurse visits for HPV vaccination (less fuss), and describe the immunological and logistical benefits of early vaccination (right now).
15919449|NCT03501992|Behavioral|Audit-and-feedback|The intervention includes two components. The first is a missed opportunities audit-and-feedback. The second is a provision of a strong recommendation provider-toolkit, along with a broad education of the practice staff-nurses, medical secretaries, receptionists, and clinical assistants-regarding the nature of the intervention, its goals, and its likely impact on the practice. The broad education will be conducted through supervisory communications only to practice staff in practices allocated to the intervention at the beginning of the step.
15919450|NCT03501992|Behavioral|Combined reminder-recall and audit-and-feedback|The combination reminder-and-audit arm consists of a simultaneous application of the intervention tested in the reminder-recall arm and the intervention tested in the audit-and-feedback arm.
15919451|NCT03501979|Drug|Tucatinib|Tucatinib study drug is given in tablet form and taken daily.
15919452|NCT03501979|Drug|Trastuzumab|Trastuzumab is approved by the FDA and is available commercially. Trastuzumab must be prepared and is administered intravenously.
15919453|NCT03501979|Drug|Capecitabine|Capecitabine is approved by the FDA and is available commercially as an oral drug.
15919454|NCT03501966|Drug|Acetazolamide|Medical therapy including diet
15919455|NCT03501966|Procedure|Optic Nerve Sheath Fenestration|Medical therapy including diet + optic nerve sheath fenestration
15919456|NCT03501966|Procedure|Ventriculoperitoneal CSF Shunting|Medical therapy including diet + ventriculoperitoneal CSF Shunting
15919457|NCT03501953|Behavioral|Physical Activity|Six weeks of instructor-led physical activity sessions.
15919458|NCT03501940|Procedure|Computed Tomography|Undergo 18F-DCFPyL PET/CT
15919459|NCT03501940|Radiation|Fluorine F 18 DCFPyL|Given IV
15919460|NCT03501940|Other|Laboratory Biomarker Analysis|Correlative studies
15919461|NCT03501940|Procedure|Positron Emission Tomography|Undergo 18F-DCFPyL PET/CT
15919462|NCT03501927|Diagnostic Test|FOCUS (focused cardiac ultrasound)|"A ultrasound of the heart and pleura will be performed. This provide information on
~Left ventricular systolic function
~Left ventricular diastolic function
~Right ventricular systolic function
~Right ventricular pressure overload
~Biventricular sizes
~Pathology of the mitral- and aortic valves
~Pericardial fluid
~Gross fluid status
~Pleural effusion"
15919463|NCT03501914|Behavioral|Mindfulness|A mindfulness program based on mindfulness-based principles developed by colleagues in Manchester will be adapted to be accessible for people with intellectual disabilities (ID) in Pakistan. This intervention will be translated into Urdu afterwards focus group will be conducted to get the views from people with ID, thei care takers and other stake holders to adapt and culturally modify the program. It will include some mindfulness based exercises i.e.welcome & introduction, exploring senses, its all in the mind, Mindful eating, breathing, soles of the feet, body scan, guided meditation, mindful stretching and walking.
15919464|NCT03501901|Diagnostic Test|Antibiotic susceptibility test|
15919465|NCT03501888|Behavioral|Cognitive Behavior Therapy|18 sessions of individual treatment, no manual.
15919466|NCT03501888|Behavioral|Acceptance and Commitment Therapy|18 sessions of group treatment, manual based.
15919467|NCT03501875|Radiation|CAC Score|Computed tomography angiography (CTA) with an injection of iodine-rich contrast material
15919468|NCT03501862|Behavioral|Mindfulness-based cognitive therapy (psychosis)|A small group intervention is based on a structured and validated protocol that will include mindfulness practice, cognitive skills
15919469|NCT03501862|Behavioral|Psychoeducation (psychosis)|A small group intervention will be focusing on understanding of psychosis, treatment, relapse prevention and useful information and resources.
15919470|NCT03501849|Device|Polypectomy using a cold snare|Polypectomy by cold-snare technique
15919471|NCT03501836|Device|Rapid Rhythm Handheld 8-lead ECG Device|"We want to explore whether using 6 electrodes on the chest (as in the Rapid Rhythm Handheld 8-lead ECG device) can give the same diagnostic result to the standard 10 electrode (12-lead) ECG, which uses 6 chest electrodes plus 4 electrodes on the arms and legs.
~To do this we need to compare measurements taken with the 6 electrode (8 lead) study device to those taken with the gold-standard 10 electrode (12 lead) method.
~We want to find out whether the new equipment can detect the same heart rhythms as the standard method, so that ECG measurements might be made more quickly and easily in the future."
15919472|NCT03501823|Other|Photoacoustic tomography|A non-invasive, safe modality that relies on light and sound to generate images.
15919473|NCT03501810|Device|Distractor use for vertebrae separation|Distractor use where separation of vertebrae is required, including corpectomy, insertion of disc prosthesis, insertion of an anterior lumbar interbody fusion (ALIF) cage, and tumor surgery
15919474|NCT03501797|Behavioral|Singing-based rehabilitation|The singing-based rehabilitation is a combination of group-training (16 weeks, 1 x week, 90 min), which utilizes a novel combination of traditional senior choir singing and singing-based speech training protocols, and home training (16 weeks, ≥ 3 x week, ≥ 30 min) in which the choir material is trained with a tablet computer.
15919475|NCT03501797|Other|Standard care|Standard care comprises all rehabilitation and care services (e.g. speech therapy, physical and occupational therapy, neuropsychological rehabilitation) received by the patients in the Finnish health care system
15919476|NCT03501784|Device|Nobio particles incorporated within Novidia Dental Bonding|Nobio particles incorporated within Novidia Dental Bonding and Flow
15919477|NCT03501784|Device|Filtek bond and flow composite|standard of care class V composite restoration performed with Filtek and 3M
15919478|NCT03501771|Other|Acupuncture|Disposable acupuncture needles will be inserted into acupoints (BL23, BL25, BL40) bilaterally for a depth of 10-30 mm
15919479|NCT03501758|Diagnostic Test|Ultrasound|Transabdominal ultrasound of the bowel for categorisation of disease activity
15919480|NCT03501758|Diagnostic Test|Analysis of prouroguanyline and uroguanyline in full blood|Withdrawal of full blood at each study visit, Storage in biobank. Analysis of prouroguanyline and proguanyline.
15919481|NCT03501745|Behavioral|WeChat|Through remote management and propaganda of intelligent mobile phone, the standard rate of blood pressure control and the change of renal function were observed.
15919482|NCT03501732|Behavioral|Values Affirmation|Experimental Group selects two values and describes why they are important
15919483|NCT03501732|Behavioral|Risk Feedback|Experimental and comparator conditions both receive normative feedback in domains of risk
15919484|NCT03501719|Drug|Number of drugs in the ART regimen|Triple therapy vs. dual therapy vs. monotherapy
15919485|NCT03501706|Behavioral|Sequenced Recall of Digits--Auditory|Auditory digit sequence AT memory component.
15919486|NCT03501706|Behavioral|Sequenced Reverse Recall of Digits--Auditory|Reversed auditory digit sequence AT memory component.
15919487|NCT03501706|Behavioral|Sequenced Recall of Words--Visual|Visual word sequence AT memory component
15919488|NCT03501706|Behavioral|Verbal Memory--Visual|word recognition AT memory component
15919489|NCT03501693|Device|DBT plus S-View|DBT plus S-View images
15919490|NCT03501693|Device|FFDM Alone|FFDM alone images
15919491|NCT03501680|Drug|Insulin|"Group A: intensive insulin (glycemic control 4.4-6.1mmol/L), Group B: standard insulin (glycemic control 7.8-10.0 mmol/L), and Group C: plasmapheresis.
~Insulin was injected by insulin pump."
15919492|NCT03501680|Device|plasmapheresis|Triglyceridemia should be less than 5.65 mmol/l.
15919493|NCT03501667|Other|Use of decision support tool|use of a decision support software during clinical assessment of a case
15919494|NCT03501667|Other|Use of UpToDate|Control group, participants using current literature prior to assessing a clinical case. Allowing 10 minutes to read on a topic during clinical care is an active intervention in the study participant fund of knowledge.
15919495|NCT03501654|Device|TecnisSymfony®|Patients received implantation of unilateral or bilateral TecnisSymfony® IOL after phacoemulsification by a single surgeon (MK Kim).
15919496|NCT03501641|Other|image-based virtual reality learning|The participants will use a whole-view, 360 degree image-based virtual reality to learn a competence of history taking and physical examination for otolaryngology and they can see the response of the staffs and standard patients (including image, voice, face expression, movement, ... etc).
15919497|NCT03501641|Other|video-based learning|voice of the staffs and standard patients.
15919498|NCT03501628|Dietary Supplement|Placebo|Supplementation twice daily (1 serving dose per consumption) of maltodextin while engaging in resistance training 3 times per week for a 12-week period. Supplementation occurred during training and non-training days.
15919499|NCT03501628|Dietary Supplement|L-leucine + maltodextrin|Supplementation twice daily (1 serving dose per consumption) of L-leucine + maltodextin while engaging in resistance training 3 times per week for a 12-week period. Supplementation occurred during training and non-training days.
15919500|NCT03501628|Dietary Supplement|Whey protein concentrate|Supplementation twice daily (1 serving dose per consumption) of whey protein concentrate while engaging in resistance training 3 times per week for a 12-week period. Supplementation occurred during training and non-training days.
15919501|NCT03501628|Dietary Supplement|Hydrolyzed whey protein concentrate|Supplementation twice daily (1 serving dose per consumption) of hydrolyzed whey protein concentrate while engaging in resistance training 3 times per week for a 12-week period. Supplementation occurred during training and non-training days.
15919502|NCT03501628|Dietary Supplement|Soy protein concentrate|Supplementation twice daily (1 serving dose per consumption) of soy protein concentrate while engaging in resistance training 3 times per week for a 12-week period. Supplementation occurred during training and non-training days.
15919503|NCT03501615|Drug|Moxetumomab Pasudotox|A recombinant conjugated immunotoxin composed of a disulfide-stabilized anti-CD22 Ig Fv genetically fused to a truncated form of Pseudomonas exotoxin, PE38
15919504|NCT03501602|Device|LMA protector|In this arm the LMA protector will be inserted. The time from took the LMA to placement of the LMA will be recorded. In patients with adequate ventilation, an Aintree catheter placed on a fiberoptic bronchoscope in LMA will be delivered. Cord vocals will be seen on the monitor and the aintree catheter will be sent into the trachea. After the insertion of the trachea, the fiberoptic bronchoscope and LMA are removed and the patient's intubation tube is advanced through the Aintree catheter to the patient's trachea. Once you have made sure that the tube is in the trachea, it will be removed. The time from insertion of the LMA to placement of the endotracheal tube will be recorded.
15919505|NCT03501602|Device|I-gel LMA|In this arm the I-gel LMA will be inserted. The time from took the LMA to placement of the LMA will be recorded. In patients with adequate ventilation, an Aintree catheter placed on a fiberoptic bronchoscope in LMA will be delivered. Cord vocals will be seen on the monitor and the aintree catheter will be sent into the trachea. After the insertion of the trachea, the fiberoptic bronchoscope and LMA are removed and the patient's intubation tube is advanced through the Aintree catheter to the patient's trachea. Once you have made sure that the tube is in the trachea, it will be removed. The time from insertion of the LMA to placement of the endotracheal tube will be recorded.
15919506|NCT03501576|Biological|Inactivated Influenza Vaccine|Given seasonal inactivated influenza vaccine IM
15919507|NCT03501550|Drug|CDI-31244|investigational drug
15919508|NCT03501550|Drug|SOF/VEL|sofosbuvir and velpatasvir fixed dose combination
15919509|NCT03501537|Procedure|Free gingival graft obtained from the palate and debridement of the peri-implant lesion|granulation tissue debridement and grafting of a free gingival strip obtained from the palate
15919510|NCT03501524|Device|VATS evacuation|the patient will be randomized to a Video-Assisted thoracoscopy for retained haemothorax
15919511|NCT03501524|Device|thoracostomy tube|the patient is randomized to reinsertion of a Thoracostomy Tube for retained haemothorax
15919512|NCT03501511|Behavioral|IDF modules|Patients in this arm will receive Pre-Ramadan education using IDF module for 4 weeks prior to Ramadan fasting
15919513|NCT03501511|Behavioral|Conversational Maps|Patients in this arm will receive Pre-Ramadan Education using Ramadan Fasting Diabetes conversation map for 4 weeks prior to Ramadan fasting
15919514|NCT03501498|Drug|Loperamide|Alters intestinal transit time.
15919515|NCT03501498|Drug|Senna|Alters intestinal transit time.
15919516|NCT03501472|Behavioral|text-only PWL|
15919517|NCT03501472|Behavioral|low-emot PWL|
15919518|NCT03501472|Behavioral|high-emot PWL|
15919519|NCT03501472|Behavioral|immed posttest|
15919520|NCT03501472|Behavioral|delay posttest|
15919521|NCT03501459|Drug|Rituximab|
15919522|NCT03501433|Dietary Supplement|Nicotinamide riboside chloride (Niagen)|250 mg capsules 2x/day for 7 days
15919523|NCT03501433|Dietary Supplement|Placebo|2x/day for 7 days
15919524|NCT03501420|Other|Interview|A one hour survey interview will be completed by the rheumatologists which will contain open and closed questions to probe physician perception and behaviors in relation to pSS management and treatment
15919525|NCT03501420|Other|PSC questionnaire|All subjects for whom the physician completes a PRF will be required to complete a PSC questionnaire independently of their physician, immediately after consultation.
15919526|NCT03501420|Other|PRFs|PRFs will be completed by the physicians for seven of their consulting pSS subjects.
15919527|NCT03501407|Diagnostic Test|Blood samples|1 or 2 blood samples will be collected from the patient.
15919528|NCT03501407|Diagnostic Test|skin biopsy|A skin biopsy will be performed on the periphery of the erythema migrans
15919529|NCT03501394|Other|Magnetic Resonance Imaging|Patients will undergo 4 MRI sessions during NACT treatment. The first scan will take place at treatment baseline before their first cycle of NACT treatment. The second scan will take place following the first treatment cycle prior to the second treatment cycle. Likewise, the third and last scan will take place after the third treatment cycle and sixth (final) treatment cycle prior to surgery. MRI scan sessions will be composed of research scans including diffusion and lipid profiling MR imaging methods and MR spectroscopy (MRS) methods.
15919530|NCT03501394|Other|Histopathological Analysis|Study specific analysis will be performed on the core biopsy and tissue removed in surgery following the completion of NACT treatment. Standard routine histological analysis will be performed, as well as study specific analysis for immunostaining, grading and slide scan imaging for measurement of cellularity markers.
15919531|NCT03501394|Other|Health Questionnaire|Health and demographic information will be collected.
15919532|NCT03501381|Drug|Entinostat|Entinostat should be taken 1-2 hours prior to the HD IL-2 infusion. Dose reductions for entinostat should be followed. Entinostat will continue after high dose IL-2 every 2 weeks
15919533|NCT03501381|Drug|Interleukin-2|In the event of clinical benefit after a course of HD IL-2 (stable disease or tumor shrinkage) patients will receive a second treatment course of HD IL-2 therapy. Patients with evidence of tumor shrinkage after the 2nd HD IL-2 treatment course may receive a 3rd treatment course of HD IL-2.
15919534|NCT03501368|Drug|Ceritinib|Participants will take ceritinib by mouth (PO) once daily at a dose of up to 450 mg (3 capsules of 150 mg)
15919535|NCT03501368|Drug|Trametinib|Participants will take trametinib by mouth at a dose of 2 mg daily
15919536|NCT03501355|Device|Inspiratory muscle strength training|"Treatment group will receive inspiratory muscle training (IMT) using threshold loading device (POWERbreathe Classic, IMT Technologies Ltd. Birmingham, England) at 50% of maximal inspiratory pressure (MIP).
~The MIP will be measured at supervised session each week, and 50% of measured MIP value will be the new training workload.
~The treatment group will train for 30 min-per/day, 7 days/week, for 8 weeks. Six sessions at home and 1 session will be performed at department."
15919537|NCT03501355|Device|Inspiratory muscle endurance training|"Treatment group II will receive inspiratory muscle endurance training (IMT) using threshold loading device (POWERbreathe Classic, IMT Technologies Ltd. Birmingham, England) at 30% of maximal inspiratory pressure (MIP).
~The MIP will be measured at supervised session each week, and 30% of measured MIP value will be the new training workload.
~The treatment group will train for 30 min-per/day, 7 days/week, for 8 weeks. Six sessions at home and 1 session will be performed at department."
15919538|NCT03501342|Other|Virtual reality group|"Immersive virtual reality training protocol consisted of Football and Guillotine games."
15919539|NCT03501342|Other|Dynamic Balance Training|Dynamic balance training protocol consisted of holding the ball and running away from the ball with a physiotherapist.
15919540|NCT03501329|Combination Product|Biological,Psychological and Social support|
15919541|NCT03501316|Device|Hand Instrumentation Treatment|Provision of treatment for periodontal disease using hand instrumentation. Following this, data will be collected relating to various factors, principle of which being systemic immune response.
15919542|NCT03501316|Device|Ultrasonic Instrumentation Treatment|Provision of treatment for periodontal disease using ultrasonic instrumentation. Following this, data will be collected relating to various factors, principle of which being systemic immune response.
15919543|NCT03501303|Procedure|No touch technique|Veins for CABG is harvested with the no touch technique
15919544|NCT03501303|Procedure|Control technique|Veins for CABG is harvested with the Control technique.
15919545|NCT03501290|Dietary Supplement|Fortimel® Protein supplementation|"Patients are supposed to take Fortimel® Protein once daily during the study period. The prescription is one unit a day.
~First prescription of the study product will be done for one month. Prescription will be repeated for 2 additional months only after the patient's nutritional status and its global health status, as well as tolerability and compliance to the ONS, were re-assessed during the first follow-up visit at one month."
15919546|NCT03501277|Drug|Alogliptin|Alogliptin tablets.
15919547|NCT03501277|Drug|Pioglitazone|Pioglitazone tablets.
15919548|NCT03501277|Drug|SYR-322-4833 BL|SYR-322-4833 BL FDC tablets.
15919549|NCT03501264|Behavioral|Online Game|LGBTQ Bullying game
15919550|NCT03501264|Behavioral|LGBTQ Resources|This group receives LGBTQ Resources
15919551|NCT03501251|Drug|Moxidectin 8mg|Participants will receive the tablet with clean water and a package of biscuits.
15919552|NCT03501251|Drug|Moxidectin 8 mg + albendazole 400 mg|Participants will receive the tablets with clean water and a package of biscuits.
15919553|NCT03501251|Drug|Moxidectin 16 mg|Participants will receive the tablets with clean water and a package of biscuits.
15919766|NCT03499704|Drug|Pioglitazone + Alogliptin|Pioglitazone and Alogliptin FDC tablets
15919554|NCT03501251|Drug|Moxidectin 16 mg + albendazole 400 mg|Participants will receive the tablets with clean water and a package of biscuits.
15919555|NCT03501251|Drug|Moxidectin 24 mg|Participants will receive the tablets with clean water and a package of biscuits.
15919556|NCT03501251|Drug|Moxidectin 24 mg + albendazole 400 mg|Participants will receive the tablets with clean water and a package of biscuits.
15919557|NCT03501251|Other|Placebo|Participants will receive the tablet with clean water and a package of biscuits.
15919558|NCT03501238|Other|Chocolate Milk|Chocolate bovine milk will be consumed everyday for 1 week. Milks will be store-bought, with added sucrose and added cocoa powder.
15919559|NCT03501238|Other|Chocolate milk substitute|Chocolate milk substitute will be consumed everyday for 1 week. Milks will be store-bought, with added sucrose and added cocoa powder.
15919560|NCT03501238|Other|Chocolate milk substitute with gelatin|Chocolate milk substitute with gelatin added will be consumed everyday for 1 week. Milks will be store-bought, with added sucrose and added cocoa powder.
15919561|NCT03501225|Procedure|ozone|After local anesthesia, it was performed sulcular incision with scalpel blade number 15 and removal of soft tissues. Osteotomy was performed at low rotation and odontosecion at high speed, under constant irrigation with ozonated water. Tooth removal, careful curettage, bone regularization and surgical shop cleaning were then performed under abundant irrigation with ozonated water according to randomization. The suture was then performed.
15919562|NCT03501225|Procedure|water|After local anesthesia, it was performed sulcular incision with scalpel blade number 15 and removal of soft tissues. Osteotomy was performed at low rotation and odontosecion at high speed, under constant irrigation with redistilled water. Tooth removal, careful curettage, bone regularization and surgical shop cleaning were then performed under abundant irrigation with redistilled water according to randomization. The suture was then performed.
15919563|NCT03501212|Drug|Topical Anesthetic|EMLA Cream 2.5 gr applied to both wrists
15919564|NCT03501212|Drug|Placebo|Placebo Cream 2.5gr applied to both wrist
15919565|NCT03501199|Other|platelet-rich fibrin placement|filling the buccal gap with platelet-rich fibrin after immediate dental implant placement
15919566|NCT03501199|Other|xenogenic graft placement|filling the buccal gap with xenogenic graft after immediate dental implant placement
15919567|NCT03501199|Other|no extra material|filling the buccal gap with no material after immediate dental implant placement
15919568|NCT03501199|Procedure|tooth extraction|extraction of tooth which is unrestorable
15919569|NCT03501199|Procedure|immediate implant placement|putting dental implant into a socket which has been prepared with compatible drills
15919570|NCT03501199|Other|collagen membran placement|placing collagen membran on extraction socket after dental implant placement to cover all
15919571|NCT03501199|Procedure|raising flap|raising the buccal flap with two vertical incision to cover extraction socket for primary closure
15919572|NCT03501186|Other|Backward walking on sand|the patient will be walking backwards on sand with therapist standing close to support in case of fall.
15919573|NCT03501173|Other|Standard of Care|Participants will not receive any intervention in this study. Participants will receive standard of care therapy.
15919574|NCT03501160|Other|Face-to face semi-structured in-depth interview|Face-to face semi-structured in-depth interview will be arranged in order to explore the inappropriate social behavior and caregiver stress from caregivers. The interview will be guided by a semi-structured interview guide which specially designed for exploring clinical picture of inappropriate social and affectionate behavior and caregiving distress. The interview guide mainly consisted of specific questions and open-ended questions that encourage the subjects to talk freely in relevant topics during interview. Demographic data was also collected in the beginning of interview. Each interview will be conducted around 60 minutes until data saturated. The interview will be audio-taped with informed consent from subjects.
15919575|NCT03501147|Other|Resistance training|15 minutes of resistance training during work every day
15919576|NCT03501134|Device|NovoTTF|We are studying the effect of Tumor Treating Fields (NovoTTF), for example Optune™, on the quality of life, including exercise, sleep quality, and mood, of patients with malignant glioma who plan to use the NovoTTF device.
15919577|NCT03501108|Other|STOPPFrail deprescribing criteria|STOPPFrail is a recently validated set of explicit deprescribing criteria devised specifically for use in older patients with advanced physical and /or mental morbidity such that the 1-year survival prognosis is likely to be poor. STOPPFrail-defined medications that appear on the patient's medication list are highlighted to the attending physician for his/her consideration for deprescribing i.e. removal from the medication list immediately or gradually as appropriate.
15919578|NCT03501095|Diagnostic Test|Vocal analysis and Laryngostroboscopy|"Vocal analysis study the acoustic emission of the pneumo-phono-articulatory system, i.e. the vocal signal. Currently, digital technology instruments enable the processing and analysis of the verbal signal quickly and reliably, also offering graphical products and numerical data. Among the various existing software products for the study of the vocal signal, PRAAT is available. In practice, the vocal parameters are acquired in a non-invasive way with a microphone.
~Laryngostroboscopy is one of the most widely used techniques for laryngeal clinical evaluation. This is a non-invasive endoscopic practice performed by means of a flexible fibroscope, which, through a pulsed light source, allows visualization of the chordal movement."
15919579|NCT03501082|Other|L Reuteri PB-W1 Strain|L. Reuteri PB-W1 strain will be prepared in accordance to the standardized operating procedures to prepare Lactobacillus reuteri in food grade conditions
15919580|NCT03501082|Other|L. Reuteri DSM20016T Strain|L. Reuteri DSM20016T strain will be prepared in accordance to the standardized operating procedures to prepare Lactobacillus reuteri in food grade conditions
15919581|NCT03501082|Other|Placebo|2 g of maltodextrin will be dissolved in 50 ml water in food grade conditions
15919582|NCT03501069|Drug|TAK-418|TAK-418 capsules.
15919583|NCT03501069|Drug|TAK-418 Matching Placebo|TAK-418 matching placebo capsules.
15919584|NCT03501056|Biological|Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Lung cancer|CIK cells was activated by PD-1 inhibitor and bispecific antibody of anti-CD3/MUC1
15919585|NCT03501056|Procedure|Cryotherapy|the maximum tumor length≥2 cm，cool down the lesion,result in degeneration, necrosis or loss of the lesion.
15919620|NCT03500822|Procedure|Expiratory-stenosis breathing|three cycles: BF - /min, I : E - 1 : 3; stenosis: 3mm; 2mm; 1,5mm
15919767|NCT03499704|Drug|Alogliptin|Alogliptin tablets.
15919586|NCT03501043|Drug|Dysport|Dysport 1000 to 1500 units to be distributed on the basis of clinical indication to ankle plantar flexors (gastrocnemius and soleus), knee extensors and flexors, tibialis posterior and long toe flexors.
15919587|NCT03501030|Behavioral|Activity restriction|Women in the intervention group will be recommended activity restriction. Activity restriction is defined as the following forms of activity restriction: pelvic rest and prohibition of sexual activity, reduction of work and/or non work activity. Bed rest will not recommended.
15919588|NCT03501017|Other|physical activity program|"The 12-week physical activity program was implemented under the guidance of nurse, in outdoors with the group, 5 days a week with warm up and cooling down for 10 minutes and normal walking tempo at a moderate pace for 30-45 minutes (3-6 km/hour).
~Application of WHO Smoking Cessation Algorithm: After fagerström test was applied, the modified smoking cessation algorithm of WHO was applied to the individuals and those who decided to quit smoking were referred to smoking cessation outpatient clinics."
15919589|NCT03501017|Other|Routine Practice|As routine practice, a brochure provided from the Public Health Directorate on protection from CVD was delivered to the individuals in the control group.
15919590|NCT03501004|Device|Sterile acupuncture needles for single use|Sterile acupuncture needles for single use are made by China Beijing Zhongyan Taihe Medical Instrument Limited Company.Acupuncture needles' specifications are 0.25mm*25mm.
15919591|NCT03500991|Biological|HER2-specific chimeric antigen receptor (CAR) T cell|Autologous CD4 and CD8 T cells lentivirally transduced to express a HER2 specific chimeric antigen receptor (CAR) and EGFRt given via indwelling central nervous system (CNS) catheter
15919592|NCT03500978|Behavioral|Peer CBT Intervention|Peer specialist delivery of cognitive behavioral therapy intervention over the phone.
15919593|NCT03500965|Behavioral|text-only PWL|control condition (no image)
15919594|NCT03500965|Behavioral|graphic PWL|pictorial warning
15919595|NCT03500965|Behavioral|absolute risk|Percentage risk information for smoking-related diseases for smokers
15919596|NCT03500965|Behavioral|relative risk|Percentage risk information for smoking-related diseases for smokers and non-smokers
15919597|NCT03500952|Other|Birth Control After Pregnancy|A 27-page patient decision aid in portable document format (and an accompanying 3-page supporting document in portable document format) hosted online.
15919598|NCT03500952|Other|Postpartum Birth Control|A 4-page patient information leaflet in portable document format and text format hosted online.
15919599|NCT03500939|Drug|Medical oxygen|inhalation of 100% oxygen at high flow via a sealed non-rebreather face-mask with reservoir
15919600|NCT03500939|Other|Standard of care|e.g. thrombectomy, thrombolysis
15919601|NCT03500926|Device|total hip replacement - standard femoral stem|total hip replacement with standard femoral stem
15919602|NCT03500926|Device|total hip replacement - short femoral stem|total hip replacement with short femoral stem
15919603|NCT03500913|Drug|Growth Hormone|Patients will receive growth hormone replacement therapy as per standard clinical care during this study.
15919604|NCT03500900|Drug|Vildagliptin 50 mg|Acute administration of Vildagliptin, 50 mg.
15919605|NCT03500900|Drug|Placebo Oral Tablet|Acute administration of placebo tablet
15919606|NCT03500887|Device|intragastric bag|
15919607|NCT03500874|Drug|FUDR|Floxuridine(FUDR) 0.12 mg/kg/day，on Day 1-14 through the HAI pump.
15919608|NCT03500874|Drug|Oxaliplatin|Oxaliplatin 180 mg/m2 IV over 90 minutes on Day 1, 15.
15919609|NCT03500874|Drug|Leucovorin|Leucovorin 200mg/m2 ivd over 2 hours on Day 1
15919610|NCT03500874|Drug|5FU|followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion on Day 1.
15919611|NCT03500861|Other|Dry Needling|"The trigger point DN procedure was performed by a certified physiotherapist. While the patient was sitting, the therapist firstly cleaned the area with alcohol. Then, DN was applied into the active TrPs on the basis of the technique described by Hong (19). The needle remained in the trigger points for 20 minutes. Upon removal of the needle, the area was compressed firmly with a cotton swab for 60 secs. The DN procedure used sterile stainless-steel acupuncture needles of 0.25x40 mm and 0.25x 25 mm dimensions (Hua Long ®). DN was applied three times a week for 2 weeks, in previously diagnosed active trigger points located in the musculature of the head and the neck.
~the Sham Dry Needling procedure was applied into the adipose tissue located at any area where an active TrPs was absent."
15919612|NCT03500848|Drug|Tacrolimus|Tacrolimus will be started between 3 and 7 days post-transplantation and continued after randomization at a dose of 1.0 mg twice a day (bid, 2 mg daily dose). The tacrolimus trough level is measured twice a week for 1 month, followed by trough level once a month thereafter. Tacrolimus trough levels are targeted to be maintained at 8-15ng/ml until Month 6. After Month 6, the dose will be adjusted over time to maintain steady-state tacrolimus trough blood levels of approximately 5-10 ng/mL.
15919613|NCT03500848|Drug|Tacrolimus (Tacrolimus elimination)|Tacrolimus will be started between 3 and 7 days post-transplantation at a dose of 1.0 mg twice a day (bid, 2 mg daily dose) for 30 (± 5) days and eliminated when randomization is done.
15919614|NCT03500848|Drug|Sirolimus|Within 24 hours of randomization, sirolimus will be started at a dose of 2.0 mg once a day. The sirolimus trough level is measured twice a week for 1 month, followed by trough level once a month thereafter. The dose will be adjusted over time to maintain steady-state sirolimus trough blood levels of approximately 4-10 ng/mL.
15919615|NCT03500848|Drug|MMF and/or steroids|For patients in both groups, MMF and/or steroids are initiated at or prior to the time of liver transplantation according to local practice. Steroids reduction is encouraged by 3 months post liver transplantation.
15919616|NCT03500835|Behavioral|App|"6 month app intervention: Problem Food Withdrawal, Snacking Elimination and Food Amount Reduction
~Daily Weigh In
~App based reminders
~Follow Up: Face-to-face clinic visits at 3,6,12 and 18 months."
15919617|NCT03500835|Behavioral|Coaching|"6 month addiction based intervention: Problem Food Withdrawal, Snacking Elimination and Food Amount Reduction.
~Daily Weighing
~Daily Text messages from Coach
~Weekly 15 minute phone meetings with Coach
~Follow Up: Face-to-face clinic visits at 3,6,12 and 18 months post consent"
15919618|NCT03500835|Behavioral|Clinic: Modified KidsNFitness|"6 month in-clinic, evidence-based, multi-disciplinary intervention
~90 minute sessions, in clinic that occur every month for 6 months
~Follow Up: Face-to-face clinic visits Monthly x 6 months followed by face-to-face visit at12 and 18 months."
15919619|NCT03500822|Procedure|Metronome-paced tachypnea|three cycles: breathing frequency (BF) - 40/min, inspiration : expiration (I : E) - 1 : 1; BF - 40/min, I : E - 1 : 2; BF - 30/min, I : E - 1 : 2
15919621|NCT03500809|Procedure|Aqueous release of the wound|"Anaesthetic drop (tetracaine 1%) followed by povidone iodine 5% drop is instilled. After 5 minutes, a sterile 30 gauge needle tip is pressed on the posterior lip of the one of the existing cuts (paracentesis or main wound) from cataract surgery to release the fluid and consequently the pressure.
~This will be performed under careful monitoring to avoid any undesirable shallowing of the anterior chamber of the eye."
15919622|NCT03500796|Procedure|Platelet rich plasma clot implantation|Implantation of a platelet rich plasma clot, which is created from the plasma of the patients, and refrigerated to be inserted under the sealing amniotic membrane
15919623|NCT03500796|Procedure|Wound closure with amniotic membrane|Closure of the corneal perforation with a synthetic amniotic membrane with a 2 mm safety margin
15919624|NCT03500783|Drug|Nitric Oxide|40 ppm of exogenous gaseous nitric oxide is supplied directly to the oxygenator in the cardiopulmonary bypass circuit during coronary artery bypass grafting.
15919625|NCT03500783|Other|Standard CPB|Standard protocol of delivery of air gas mixture to the cardiopulmonary bypass circuit
15919626|NCT03500770|Device|Transcranial Direct Current Stimulator|The tDCS device to be used will be an investigational, battery powered, custom-made stimulator able to deliver a biphasic alternate current. Active stimulation consists of 10 active tDCS sessions with current intensity fixed at 2mA for 20 minutes. It has been safely used in several other research studies. The side effects profile for this type of stimulation include tingling/itching at the site of stimulation, skin irritation/redness at the site of stimulation, headache or dizziness.
15919627|NCT03500757|Device|HoloLens|use the HoloLens to evaluate new 3D holographic guidance and navigation for percutaneous ablation of solid tumors
15919628|NCT03500744|Procedure|Erector spinae plane block|Ropivacaine 0.5% 20 mL at each site of ESPB
15919629|NCT03500744|Procedure|Sham block|Skin infiltration only
15919630|NCT03500731|Biological|CD3/CD19 negative hematopoietic stem cells|Negative selection for CD3/CD19 will be performed on CliniMACS® depletion device and given at time no less than 8 weeks post lung transplantation
15919631|NCT03500731|Drug|Rituximab|Transplantation Conditioning
15919632|NCT03500731|Drug|Alemtuzumab|Transplantation Conditioning
15919633|NCT03500731|Drug|Fludarabine|Transplantation Conditioning
15919634|NCT03500731|Drug|Thiotepa|Transplantation Conditioning
15919635|NCT03500731|Drug|G-CSF|Transplantation conditioning
15919636|NCT03500731|Drug|Hydroxyurea|Transplantation Conditioning
15919637|NCT03500718|Device|Cochlear implant|After cochlear implantation, cochlear nerve is stimulated by giving a current over the electrodes placed in the cochlea and the current is measured by electrically evoked Compound Action Potential (ECAP).
15919638|NCT03500705|Device|Mirror Therapy|Mirror Therapy involved the patient sitting on a chair at a table with a standard mirror placed on the table in the mid-sagittal plane between both arms, with the reflective side of the mirror facing the non-affected arm. The patient is instructed to observe the reflection of the non-affected arm during the sessions. The patient was not given any instruction on the use of the affected arm.
15919639|NCT03500705|Other|Cross-Education of Strengthening.|Cross-education of strengthening involves training one side of the body with the intention of producing strengthening gains on both sides of the body. In this case the strengthening was done on the non-affected arm of each stroke patient.
15919640|NCT03500692|Device|MitraClip NT System|Percutaneous mitral valve repair using MitraClip NT System
15919641|NCT03500679|Biological|ExPEC4V|Participants will receive ExPEC4V vaccine as an IM injection on Days 1 and 181.
15919642|NCT03500679|Biological|Placebo|Participants will receive placebo as an IM injection on Days 1 and 181.
15919643|NCT03500666|Device|Robot|Robot lateral neck lymph node dissection
15919644|NCT03500666|Device|Total endoscopic|Total endoscopic lateral cervical lymph node dissection
15919645|NCT03500653|Dietary Supplement|Curcumin|4 gr curcumin
15919646|NCT03500653|Dietary Supplement|Placebo|4 gr placebo
15919647|NCT03500640|Behavioral|DPP Intensive: 30-minute calls|Ongoing DPP intervention and behavioral progress review to prevent relapse and improve cardiometabolic and functional health targets as keys to healthy aging.
15919648|NCT03500640|Behavioral|DPP Support: 15-minute calls|No further behavioral intervention materials provided; phone-contacts for mutual social support and accountability
15919649|NCT03500627|Drug|OP-101|Intravenous Injection of OP-101 in healthy volunteers.
15919650|NCT03500614|Behavioral|Air cleaner use method 1|All interventions in the first cohort will start at noon on Tuesday or Thursday and continue to the next morning of Tuesday or Thursday.
15919651|NCT03500614|Behavioral|Air cleaner use method 2|All interventions in the second cohort will start from the beginning to the end of smog episodes.
15919652|NCT03500601|Other|Nut components|nut components consumed daily for a period of 28 days
15919653|NCT03500601|Other|Placebo|Placebo consumed daily for a period of 28 days
15919654|NCT03500588|Diagnostic Test|PCR|Polymerase chain reaction was used to diagnose gene polymorphism.
15919655|NCT03500588|Device|Doppler ultrasound|Doppler ultrasound was used to assess the pulsatility index of the umbilical artery .
15919656|NCT03500575|Device|photopheresis|• Treated group will receive ECP with Therakos online system. Each session consists in 1 treatment for 2 consecutive days. First session stars within 72 hours after transplantation followed by a session weekly for 3 time and 2 sessions for the next 2 months (6 sessions = 12 treatment)
15919657|NCT03500549|Drug|APL-2|Complement (C3) Inhibitor
15919658|NCT03500549|Drug|Soliris|Complement (C5) Inhibitor
15919659|NCT03500536|Behavioral|IntelliCare|A suite of mobile apps that use principles of computerized therapy to decrease symptoms of depression.
15919660|NCT03500523|Diagnostic Test|corneal biomechanical properties|We want to investigate changes of corneal biomechanical properties during pregnancy. The Ocular Response Analyzer (ORA) evaluate the in vivo corneal biomechanical properties in form of corneal hysteresis (CH) and corneal resistance factor (CRF)
15919661|NCT03500497|Diagnostic Test|RetHe measurement (Sysmex)|RetHe measurement is done from blood samples gained during standard patient care perioperatively
15919725|NCT03500055|Procedure|Abdominal Closure Bundle|Surgeons will re-scrub, change gown and gloves prior to closure of fascia. Will also use new instruments, bovie tip, suction tip, and light handles, for closure of fascia, subcutaneous tissue, and skin
15919768|NCT03499704|Drug|Metformin|Metformin tablets.
15919662|NCT03500484|Drug|Liraglutide|Liraglutide will be supplied in the following package sizes containing disposable, pre-filled, multidose pens. Each individual pen delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg or 3 mg (6 mg/mL, 3 mL). Liraglutide will be self-administered daily for 12 weeks under the following regimen: 0.6mg for 1 week, 1.2mg for 1 week, 1.8mg for 1 week, 2.4mg for 1 week, 3.0mg until week 12.
15919665|NCT03500458|Behavioral|Sleep Extension|Participants will be asked to increase time in bed at least 1 hour more than baseline
15919666|NCT03500445|Drug|Daratumumab|"Daratumumab (16 mg/kg) will be administered as an IV infusion:
~Cycle 1-2: 16 mg/kg weekly
~Cycles 3-8: 16 mg/kg IV infusion every 2 weeks
~Cycles 9-24: 16 mg/kg IV infusion Day 1"
15919667|NCT03500445|Drug|Carfilzomib|"Carfilzomib will be given as an IV infusion over 30 minutes:
~Cycle 1: 20 mg/m2 Days 1, 2; 36 mg/m2 Days 8, 9, 15, 16. Alternatively, intermediate dose escalation (to 27mg/m2 on days 8, 9 of cycle 1) will be allowed at the treating physician's discretion.
~Cycle 2-9: 36 mg/m2 (or best tolerated dose) Days 1, 2, 8, 9, 15 and 16
~Cycles 9-24: 36 mg/m2 (or best tolerated dose) Days 1, 2, 15 and 16"
15919668|NCT03500445|Drug|Lenalidomide|"Lenalidomide will be taken orally as follows:
~• Cycles 1-24: 25 mg (or best tolerated dose) PO Days 1-21"
15919669|NCT03500445|Drug|Dexamethasone|"Dexamethasone will be administered prior to carfilzomib (on days that they coincide), as follows:
~Cycles 1-9: 40 mg PO (subjects ≤ 75 years) or 20 mg PO (subjects ≥ 75 years) per week
~Cycles 9-24: 20 mg PO per week
~During weeks when daratumumab is given: 40 mg dexamethasone weekly, 20 mg prior to daratumumab infusion and 20 mg PO the day after
~During weeks with no daratumumab, single dose of 20 mg on day 1"
15919670|NCT03500432|Procedure|local anesthesia of trnasperineal prostate biopsy|three different block site with lidocaine
15919673|NCT03500406|Device|RestoreX|Penile traction therapy in the straight position
15919674|NCT03500406|Other|Control|No treatment
15919675|NCT03500393|Behavioral|Remotely Supervised Exercise (REM)|REM is designed to follow in the tradition of stepped care behavioral interventions. As such, participants who are successfully engaging in the prescribed exercise are provided minimal and automated encouragement and praise. Participants who demonstrate less adherence are given interventions that are tailored in content and intensity, depending on the level of success and the nature of the barriers to success
15919676|NCT03500393|Behavioral|Unsupervised Exercise (UNSUP)|The control condition represents a minimalist intervention that could occur in any setting: (1) enthusiastic provision on an exercise prescription and (2) provision of a fitness device (i.e., the Garmin VivioActive) that can help participants track their exercise engagement. Participants are instructed in how to use the device to track their adherence to the exercise prescription.
15919677|NCT03500380|Drug|RC48-ADC|RC48-ADC 2.0 mg/kg IV every 14 days
15919678|NCT03500380|Drug|Lapatinib|Lapatinib 1250 mg orally once daily during each 21-day cycle.
15919679|NCT03500380|Drug|Capecitabine|Capecitabine 2000 mg/m^2 orally daily on Days 1-14 of each 21-day treatment cycle.
15919680|NCT03500367|Drug|rapamycin|rapamycin, 2 mg a day, orally ,for 3months
15919681|NCT03500354|Dietary Supplement|Nutrient drink|High calorie drink with therapeutic supplements
15919682|NCT03500341|Device|INVSENSOR00014|Noninvasive pulse oximeter sensor
15919683|NCT03500328|Other|Early Aggressive Therapy or Traditional Therapy|Participants will be stratified by whether they are at higher versus lower risk for long-term disability and then randomized 1:1 to a higher-efficacy versus a traditional, first-line disease-modifying therapy (DMT) class.
15919684|NCT03500315|Other|HIV D+/R+|Kidney from an HIV-infected deceased donor
15919685|NCT03500302|Drug|Evolocumab|Evolocumab sq once a month for a total of two doses
15919686|NCT03500289|Drug|Ketamine|One intravenous infusion of ketamine 0.5 mg/kg over 40 minutes
15919687|NCT03500289|Drug|Midazolam|One intravenous infusion of midazolam 0.05 mg/kg over 40 minutes
15919688|NCT03500276|Behavioral|Yoga program|Yoga classes will be conducted 2xweekly/ 90 minutes and consist of physical exercises (asanas), breathing exercises (pranayama), relaxation and self-enquiry meditation based on Yoga in daily life system.
15919689|NCT03500276|Behavioral|Arthritis-education|Arthritis-education classes will be conducted 1xweekly/ 120 minutes and led by rheumatology specialists and consist of lectures on arthritis and related issues followed by group discussion.
15919690|NCT03500263|Drug|PTI-808|Active
15919691|NCT03500263|Drug|Placebo|Placebo
15919692|NCT03500263|Drug|PTI-801|Active
15919693|NCT03500263|Drug|PTI-428|Active
15919694|NCT03500263|Drug|Placebo|Placebo
15919695|NCT03500250|Other|Post-Stroke Depression toolkit|The Post-Stroke Depression toolkit consists of three components: (1) two screening instruments, (2) seven evidence-based nursing interventions, and (3) an instruction manual.
15919726|NCT03500042|Device|inspiratory pressure threshold device|The threshold loading device is composed of a mouth -piece attached to a small plastic cylinder that contains a spring-loaded poppet value. The valve opens to permit inspiratory flow only once the person has generated adequate negative intrathoracic pressure to condense the spring.
15919769|NCT03499704|Drug|Dapagliflozin|Dapagliflozin tablets.
15919698|NCT03500224|Drug|[14C]-TAK-954|[14C]-TAK-954 intravenous infusion.
15919699|NCT03500211|Drug|Lidoderm 5 % Topical Patch|Lidocaine patch after cesarean section delivery.
15919700|NCT03500211|Other|Sham Topical Patch|Sham patch after cesarean section delivery.
15919701|NCT03500198|Device|Investigational Intraocular Lens Device #1: Next Generation TECNIS IOL|Intraocular lens replaces the natural lens removed during cataract surgery.
15919702|NCT03500198|Device|Control Monofocal Intraocular Lens: TECNIS Monofocal IOL|Intraocular lens replaces the natural lens removed during cataract surgery.
15919703|NCT03500185|Other|PFMT in group|Participants randomized to this group will perform the PFMT protocol in a group, with physiotherapeutic supervision, lasting 1 hour, in the Outpatient Clinic of Gynecology of Hospital of Clinics of Porto Alegre (HCPA), for a period of 3 months. You will also be instructed to perform exercises at home. After this period, they will be reassessed and will follow the same protocol for another 3 months now at home. After this period, they will be evaluated again.
15919704|NCT03500185|Other|PFMT at home|Randomized participants for this group will receive guidance on the home PFMT protocol on the day of the initial evaluation. They will be instructed to perform the exercises daily for a period of 3 months. After 3 months they will be re-evaluated and will follow the same protocol for another 3 months at home. After this period they will be evaluated again.
15919705|NCT03500172|Behavioral|DTP|Provision of antiretroviral therapy (ART) in the community through a mobile-van DTP managed by a nurse capable of initiating and managing ART.
15919706|NCT03500172|Behavioral|ICM|Peer-led ICM through quarterly face-to-face meetings, monthly phone calls and biweekly text messages.
15919707|NCT03500159|Drug|AQX-1125 200 mg|Synthetic SHIP1 activator
15919708|NCT03500159|Drug|Placebo|Appearance and weight matched tablets without the active product ingredient
15919709|NCT03500146|Drug|Anticholinergic|Patients prescribed medication for OAB
15919710|NCT03500146|Procedure|PTNS|Patients prescribed PTNS for OAB
15919711|NCT03500133|Radiation|No radiotherapy if CR at the end of chemotherapy.|Adapted chemotherapy without radiotherapy
15919712|NCT03500133|Drug|Low risk with complete early response after two cycles of ABVD chemotherapy schedule. Only one more ABVD course is delivered.|Low risk with complete early response after two cycles of ABVD chemotherapy schedule. Only one more ABVD course is delivered.
15919713|NCT03500133|Drug|Low risk with partial remisssion after 4 cycles of ABVD chemotherapy schedule. Two ESHAP courses are delivered.|Low risk with partial remission at early response assessment after two cycles of ABVD chemotherpay schedule. Two ABVD courses are delivered.
15919714|NCT03500133|Radiation|IN 30Gy RT in case of PR at the end of chemotherapy|Low risk with partial remisssion after 4 cycles of ABVD and 2 ESHAP courses: IN 30Gy RT
15919715|NCT03500133|Drug|Intermediate risk with complete early response after two cycles of ABVD chemotherapy schedule. Three more ABVD courses are delivered.|Intermediate risk with complete early response after two cycles of ABVD chemotherapy schedule. Three more ABVD courses are delivered.
15919716|NCT03500133|Drug|Intermediate risk with partial remission after two cycles of ABVD chemotherapy schedule. Four more chemotherapy courses are delivered alternating ESHAP and ABVD.|Intermediate risk with partial remission after two cycles of ABVD chemotherapy schedule. Four more chemotherapy courses are delivered alternating ESHAP and ABVD.
15919717|NCT03500133|Drug|High risk with complete early response after 1 ABVD and 1 ESHAP courses. Four more chemotherapy courses are delivered alternating ESHAP and ABVD.|High risk with complete early response after 1 ABVD and 1 ESHAP courses. Four more chemotherapy courses are delivered alternating ESHAP and ABVD.
15919718|NCT03500133|Drug|High risk with partial remission after 1 ABVD and 1 ESHAP courses. Six more chemotherapy courses are delivered alternating ESHAP and ABVD.|High risk with partial remission after 1 ABVD and 1 ESHAP courses. Six more chemotherapy courses are delivered alternating ESHAP and ABVD.
15919719|NCT03500133|Drug|Low risk with partial remission at early response assessment after two cycles of ABVD chemotherpay schedule. Two ABVD courses are delivered.|Low risk with partial remission at early response assessment after two cycles of ABVD chemotherpay schedule. Two ABVD courses are delivered.
15919720|NCT03500120|Diagnostic Test|Seated saline infusion test|"Seated saline infusion test: All participants received the infusion of 2 liters of 0.9% saline over 4 h in seated posture.
~Fludrocortisone suppression test:Patients received 0.1 mg oral fludrocortisone every 6 h for 4 days, together with slow-release potassium chloride and sodium chloride supplements.
~Captopril challenge test:Patients received 50 mg captopril orally at 8-9 a.m. after sitting or standing for at least 1 h. Blood samples were drawn at time zero and 2 h after the challenge."
15919721|NCT03500107|Device|Blue Light Emitting Diode (LED) 401 +/- 5nm|The participant will be naked, in a ginecological stretcher and lithotomy position, and the apparatus of the LED will be positioned in front of the vulva and vaginal region, 5 cm away, it will be statically, externally, and supported on a tripod. The protocol will consist of only one session.
15919722|NCT03500094|Drug|migalastat HCl 150 mg|migalastat HCl 150 mg capsule
15919723|NCT03500081|Device|MRI Scan|The MRI scan will not be used for diagnostic purposes. The research team members do not use the sequences for detection of clinical conditions. This is an observational study only, with no interventions.
15919724|NCT03500068|Diagnostic Test|biopsies & blood analyses|They will take blood and a biopsy from the metastase in the patient
15919765|NCT03499730|Drug|Midazolam injection|The dose of preoperative midazolam is the predictor variable and will be registered as a continuous variable in a single cohort.
15919727|NCT03500029|Radiation|Transcranial magnetic stimulation (TMS)|TMS treatment group is treated with TMS for 20-40 minutes a time, 5 times a week. The stimulation parameters were 20 Hz and 80% MT. Each stimulation continues for 2 seconds, and the interval time of stimulation is 58 seconds.
15919728|NCT03500029|Drug|antidepressants|Medication group is treated with anti-depression for 6 weeks. The drugs and their doses belong to the first-line treatment for depression in the current guideline .
15919729|NCT03500016|Other|Acute exercise|See under arm description.
15919730|NCT03500003|Other|Acute milk intake|Food matrix: milk
15919731|NCT03500003|Other|Acute Yogurt intake|Food matrix: yogurt
15919732|NCT03499977|Behavioral|Sitting|10 min bouts
15919733|NCT03499977|Behavioral|Light-Intensity Cycling|10min bout
15919734|NCT03499977|Behavioral|Moderate-Intensity Cycling|10 min bout
15919735|NCT03499977|Behavioral|High-Intensity Cycling|10 min bout
15919736|NCT03499964|Device|Optilume Drug Coated Balloon (DCB)|The Optilume Drug Coated Balloon (DCB) is a guidewire compatible catheter with a tapered atraumatic tip. The distal end of the catheter has an inflatable balloon coated with a proprietary coating containing the drug paclitaxel that facilitates the drug's transfer to the urethral wall upon inflation.
15919737|NCT03499964|Device|Control Treatment|A control subject may be dilated with either a rod, uncoated balloon or DVIU until the desired result is reached, based on standard of care for the clinical site and treating physician
15919738|NCT03499951|Behavioral|Wheelchair Skills Training - Remote|Individuals will receive wheelchair skills training remotely. They will be provided with the Wheelchair Skills Training Program to review (http://www.wheelchairskillsprogram.ca/eng/index.php), and then will be directed to use this information to perform the wheelchair skills. They will video the attempts, and will receive feedback on methods to improve their techniques.
15919739|NCT03499951|Behavioral|Wheelchair Skills Training - In Person|Individuals will receive wheelchair skills training in one-on-one sessions, taught by those who received the wheelchair skills training remotely.
15919740|NCT03499938|Device|Structured Light Plethysmography|Non-invasive non-contact measurement of tidal breathing during hospital admission
15919741|NCT03499925|Behavioral|cognitive behaviors|Telephone consultation effectiveness and cognitive behaviors
15919742|NCT03499925|Behavioral|Telephone consultation|Telephone consultation effectiveness and cognitive behaviors
15919746|NCT03499886|Drug|Ketamine Hydrochloride 50Mg/1mL Solution for Injection|In the intervention group, ketamine 1% was administered rapidly at a dose of 0.5 mg / kg (within 5 seconds), and in the control group, ketamine 1.5 mg / kg was slowly injected for 30 to 60 seconds.
15919747|NCT03499886|Drug|Ketamine Hcl 50Mg/Ml Inj|In the intervention group, ketamine 1% was administered rapidly at a dose of 0.5 mg / kg (within 5 seconds), and in the control group, ketamine 1.5 mg / kg was slowly injected for 30 to 60 seconds.
15919748|NCT03499873|Drug|Nepafenac 0.3% Oph Susp|Nepafenac 0.3% Ophthalmic suspension (experimental product)
15919749|NCT03499873|Drug|Placebos|Placebo
15919750|NCT03499873|Drug|Nepafenac 0.3% Oph Susp (reference)|Nepafenac 0.3% Ophthalmic suspension (Innovator)
15919751|NCT03499860|Diagnostic Test|Passive Leg Raising Test|A passive leg raising test is performed in all patients included in the study
15919752|NCT03499847|Behavioral|standardised face-to-face counselling session|the healthcare provider will conduct a standardised face-to-face counselling session guided with subjects guided by a check-list of topics to cover regarding the Advanced Medical Directive.
15919753|NCT03499847|Behavioral|advanced medical directive pamphlet|A standardised pamphlet containing information about the Advanced Medical Directive produced by the Ministry of Health, Singapore.
15919754|NCT03499834|Biological|Immune Killer Cells (IKC)|Autologous cells of the immune system. Intravenous Injection (I.V.) frequency: One injection per week, twenty-four injections on-treatment
15919755|NCT03499821|Device|EDOF ICL|The Visian ICL is intended to be implanted within the posterior chamber, directly behind the iris, and in front of the anterior capsule of the human crystalline lens. It offers an intraocular alternative for the correction of refractive error in those who currently utilize spectacle and/or contact lenses correction.
15919756|NCT03499808|Biological|Isatuximab|Given IV
15919757|NCT03499808|Other|Laboratory Biomarker Analysis|Correlative studies
15919758|NCT03499795|Biological|VGX-3100|One milliliter (1 mL) VGX-3100 (deoxyribonucleic acid [DNA] plasmids encoding E6 and E7 proteins of HPV types 16 and 18) will be injected IM and delivered by EP using CELLECTRA™ 5PSP on Day 0, Week 4 and Week 12, and potentially Week 40.
15919759|NCT03499795|Device|CELLECTRA™ 5PSP|IM injection of VGX-3100 is followed by EP with the CELLECTRA™ 5PSP device.
15919760|NCT03499769|Procedure|natural orifice|laparoscopic total colon surgery and patients who are removed from the natural orifice and conventional will gather
15919762|NCT03499743|Drug|hyoscine butyl bromide|intake of 10 mg hyoscine butyl bromide (buscopan) orally in addition to a placebo similar to Celecoxib 2 hours before IUD insertion
15919763|NCT03499743|Drug|Celecoxib 200mg|Celecoxib 200mg (Celebrex® 200, Pfizer, USA) in addition to a placebo similar to hyoscine butyl bromide
15919764|NCT03499743|Drug|Placebo Oral Tablet|a placebo similar to hyoscine butyl bromide in addition to a placebo similar to Celecoxib.
15919770|NCT03499691|Device|Theranova 500 medium cut-off dialyzer|The patients randomized in this group using the Theranova 500 medium cut-off dialyzer, and blood flow rate and treatment duration will be maintained stable during the observation period. However, other prescriptions will vary based on the Principal Investigator's (PI's) judgment. If other dialyzers need to be temporarily used during the study period it shall be recorded which alternative dialyzers are used and for how long the study patient is on a different dialyzer. However, prior to Week 12 laboratory assessment it is recommended that the patient undergoes three dialysis sessions on the designated treatment mode.
15919771|NCT03499691|Device|Hemodiafiltration|The patients randomized in this group using the on-line high-flux HDF dialyzer, in post dilution mode, will continue to receive treatments according to their current treatment prescriptions for the duration of the study.
15919772|NCT03499665|Behavioral|PNF, Myofascial Releasing Maneuvers, Home Exercise Group|For Group 1 (n:20), the PNF, myofascial releasing and home exercises were used to decrease pain, jaw restriction and improve functional mobility on the masseter, lateral and medial pterygoid, buccinator, temporalis, orbicularis oris, orbicularis oculi, upper side of trapezius muscle, splenius, scalenous, and cervical extensor muscle in 20 patients with bruxism, for 2 and 6 weeks after pre-evaluation. PNF, myofascial releasing and home exercises were administered for 2 weeks, followed by 3 sets of 10 repeat home exercises and 6 weeks under physiotherapist control.
15919773|NCT03499665|Behavioral|Myofascial Releasing Maneuvers and Home Exercises Group|In Group 2 (n:15), as myofascial releasing and home exercise group,final evaluation was made with 10 sets of myofascial releasing and home exercises for 2 and 6 weeks.
15919774|NCT03499665|Behavioral|Control Group|In Group 3 (n:17), as the control group, no myofascial releasing or Proprioceptive Neuromuscular Facilitation exercises were applied.
15919775|NCT03499652|Diagnostic Test|neonatal bacterial meningitis risk score|In the validation cohort,according to the neonatal bacterial meningitis risk score, we will suggest neonates who reach certain score to take a lumbar puncture, but we will not interfere with clinicians' decision
15919776|NCT03499639|Drug|Ombitasvir / Paritaprevir / Ritonavir /Ribavirin Oral Tablet|"Patients with eGFR between 59-30ml/min: a co-formula of ombitasvir (OBV; 25mg)/ paritaprevir (PTV; 150mg)/ ritonavir (r; 100mg) (OBV/PTV/r) once-daily plus ribavirin (RIB) was given for 12 weeks. Dose adjustment of RIB was made as follow: If eGFR was 30-59 ml/min, an alternating dosing of 200 mg and 400 mg daily; if eGFR 15-30 ml/min, dosing was 200 mg once daily.
~Patients on hemodialysis: a co-formula of OBV/PTV/r (25/150/100mg) once-daily plus RIB 200 mg 3 times/week, only in the days that they have their hemodialysis settings, 4 hours before the hemodialysis setting for 12 weeks."
15919777|NCT03499626|Drug|ASLAN001|"Starting dose at 300mg BD Dose level +1: 400mg BD (which is the target dose for this study)
~Dose reduction of ASLAN001 in event of adverse events grade 2 and above:
~Dose level -1: 200mg BD Dose level -2: 100mg BD"
15919778|NCT03499613|Other|Multidisciplinary rehabilitation program|The multimodal rehabilitation program (MRP) based at the University Hospital is an intensive 3-weeks multidisciplinary rehabilitation program. Patients come daily for individual and group treatments, with a total of 100 hours of intervention during 3 weeks. The MRP includes physiotherapy treatments, aiming at improving cardio-vascular endurance, long-term physical activity adherence, proprioception, mobility and strength. Additionally, occupational therapy is mainly focussed on reassuring patients that spinal movements are safe. Finally, psychologists are involved in the MRP to discuss the meaning of LBP, the psychological implications and the patient's resources.
15919779|NCT03499600|Behavioral|Clinical Assessment and CFI|CA and CFI families will participate in the Cultural Formulation Interview prior to their standard intake.
15919780|NCT03499600|Behavioral|Clinical Assessment|CA families will participate their standard intake procedures.
15919781|NCT03499574|Behavioral|Dysphagia therapy using surface EMG as biofeedback|10 x 45 minute sessions over 14 days
15919782|NCT03499574|Behavioral|Usual Care|Usual care may include the following Speech and Language Therapy interventions; assessment, review, therapy, patient/family education etc.. Dose will vary.
15919783|NCT03499561|Diagnostic Test|urine analysis|Intervention is (urine analysis ): of a mid stream urine sample will be taken
15919784|NCT03499548|Other|INSPiRe Programme|Intensive CBT for suicide
15919785|NCT03499535|Behavioral|Radon & Smoking Synergistic|Participants viewed health information detailing the risks of developing lung cancer from exposure to radon gas, smoking, and their synergistic effects. This intervention represents the type of information most commonly presented in radon risk communications.
15919786|NCT03499535|Behavioral|Radon Only|Participants viewed health information detailing the risks of developing lung cancer from radon exposure. No information about the risks for developing lung cancer associated with smoking or its synergistic effect with radon exposure are included.
15919787|NCT03499535|Behavioral|Radon and Smoking Isolated|Participants viewed health information detailing the risks of developing lung cancer from radon exposure and smoking. No information describing the synergistic effects of smoking and radon exposure on lung cancer risk are included.
15919788|NCT03499535|Behavioral|EPA|Health information modeled after the Environmental Protection Agency's (EPA) pamphlet on radon risk.
15919789|NCT03499535|Behavioral|Idaho|Health information modeled after the Idaho Department of Health and Human Welfare's pamphlet on radon risk.
15919790|NCT03499522|Other|Observational group|"The dependent variables (pain, quality of life, anxiety and coping strategies) and the outcome measures used to measure these variables will be:
~Numerical scale of pain
~Short Form 36 Health Survey [SF-36].
~State-Trait Anxiety Inventory [STAI].
~Tampa Scale of Kinesiophofia [TSK-11SV].
~Pain catastrophizing scale [PCS].
~Coping Strategies Questionnaire [CSQ]."
15919791|NCT03499509|Other|Low Glycemic Diet|"Low Glycemic (LG) diet: The LG diet will be made up of foods that do not stimulate insulin secretion. The foods that make up the diet will differ depending on the phase of the study. During the weight loss phase, breakfast and lunch will each consist of one or two meal-replacement shakes (e.g., High-Protein SlimFast). Dinner will be a frozen entrée (e.g., Atkins, Lean Cuisine, Healthy Choice) supplemented with a side of vegetables. Snacks will be nuts, berries, and full-fat dairy products (one serving per day), and will be used to adjust the calorie level of each day's meals to individual calorie needs."
15919828|NCT03499210|Device|ReWalk ReStore device|The ReWalk ReStore device is intended to be used to perform ambulatory functions in rehabilitation institutions under the supervision of a trained therapist for people with hemiplegia/hemiparesis due to stroke.
15919900|NCT03498677|Behavioral|alternative presentation order|section presentation two
15919792|NCT03499509|Other|High Glycemic Diet|"High Glycemic (HG) diet: The HG diet will conform to United States Department of Agriculture (USDA) guidelines (http://health.gov/dietaryguidelines/2015/guidelines/). The foods that make up the diet will differ depending on the phase of the study. During the weight loss phase, breakfast and lunch will each consist of one or two meal-replacement shakes (e.g., SlimFast). Dinner will be a frozen entrée (e.g., Lean Cuisine, Healthy Choice) supplemented with a side of vegetables. Snacks will be fruit, fat-free dairy products, and low-fat bars (e.g., Optifast), and will be used to adjust the calorie level of each day's meals to individual calorie needs."
15919793|NCT03499496|Diagnostic Test|ultrasound guided detection of atherosclerotic plaques|screening by ultrasound of atherosclerotic plaques
15919794|NCT03499483|Drug|bictegravir|Single One Pill Formulation of bictegravir, emtricitabine/tenofovir alafenamide (Bictarvy) to be taken once daily orally for a period of 28 days.
15919795|NCT03499470|Other|Protocol for structured discharge and follow-up|
15919796|NCT03499457|Drug|Amoxicillin|chalange test of 50 mg, and after an hour 500 mg
15919797|NCT03499444|Drug|Rucaparib|Rucaparib will be administered twice daily
15919798|NCT03499431|Device|Endovascular Thoracoabdominal Aneurysm Repair|Standard of care, treatment of thoracoabdominal aneurysms using endovascular techiniques.
15919799|NCT03499418|Other|modified Silverman scale|Clinical assessment of severity of respiratory failure
15919800|NCT03499418|Diagnostic Test|echocardiography|echocardiographic evaluation of haemodynamic problems
15919801|NCT03499405|Behavioral|Family Navigator Intervention|Caregivers will be paired with a culturally matched family navigator.
15919802|NCT03499392|Other|psychological tests|psychological tests psychological interviews
15919803|NCT03499379|Device|Mirena|A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.
15919804|NCT03499379|Device|Paraguard|A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes.
15919805|NCT03499366|Diagnostic Test|HFMS, MRC, ACTIVLIM, PedsQl-4.0|Clinical performance tests, quality of life, activity of daily life form.
15919806|NCT03499353|Drug|TALAZOPARIB|Talazoparib 1mg/day
15919807|NCT03499340|Behavioral|text-only PWL|control condition (no image)
15919808|NCT03499340|Behavioral|low arousal graphic PWL|pictorial warning
15919809|NCT03499340|Behavioral|high arousal graphic PWL|pictorial warning
15919810|NCT03499340|Behavioral|absolute risk|Percentage risk information for smoking-related diseases for smokers
15919811|NCT03499340|Behavioral|relative risk|Percentage risk information for smoking-related diseases for smokers and non-smokers
15919812|NCT03499327|Dietary Supplement|Wheat germ oil (UV treated)|"Wheat germ oil is naturally rich in vitamin D precursors (ergosterol and 7-dehydrocholesterol), which are converted into vitamin D2 and vitamin D3 by a defined UV light irradiation for the present study (wheat germ oil (UV treated).
~The wheat germ oil (UV treated) is dispensed in dark glass bottles without label. The distinction between the groups is based on the expiration date (08.05.2018 vs. 09.05.2018). The distinction between the groups is not possible for the participants.
~The daily dosage of wheat germ oil is 10 ml and the study products will be consumed over an entire period of 6 weeks (no follow-up).
~Recommendation for intake: pure before a main meal."
15919813|NCT03499327|Dietary Supplement|Wheat germ oil (untreated)|"commercial available wheat germ oil The wheat germ oil (untreated) is dispensed in dark glass bottles without label. The distinction between the groups is based on the expiration date (08.05.2018 vs. 09.05.2018). The distinction between the groups is not possible for the participants.
~The daily dosage of wheat germ oil is 10 ml and the study products will be consumed over an entire period of 6 weeks (no follow-up).
~Recommendation for intake: pure before a main meal."
15919814|NCT03499314|Device|Active RS-tDCS +At-Home Manual Dexterity Training|Bilateral M1-SO electrode placement; Active= anodal 2.0 mA dose × 20 minutes
15919815|NCT03499314|Device|Sham RS-tDCS +At-Home Manual Dexterity Training|"Designed to ensure blinding, includes initial and ending ramp-up/down stimulation for 60 seconds"
15919816|NCT03499314|Other|Manual dexterity training|Manual dexterity training will be based on the at-home study in MS by Kamm and colleagues, where the training was completed by participants in their homes and demonstrated to be superior to strength training.
15919817|NCT03499275|Device|Active NMES|Neuromuscular electrical stimulation to the quadriceps muscle
15919818|NCT03499275|Device|Sham NMES|Sham neuromuscular electrical stimulation to the quadriceps muscle
15919819|NCT03499275|Other|Home exercise programme|Home exercise programme. Both arms of the trial receive this intervention.
15919820|NCT03499275|Other|Breathlessness advice|Breathlessness advice. Both arms of the trial receive this intervention.
15919821|NCT03499262|Behavioral|Group Social ABCs|Social ABCs coach will facilitate the intervention to small groups of parents in a clinic setting, rather than the family's home. This new format allows the program to be completed in 6 weeks, versus the current 12-week model, and also offers the potential benefit of creating a parent support network within the program. Parents will still get live, one-on-one coaching for strategies to use with their child over the course of the program.
15919822|NCT03499249|Drug|N-Acetyl cysteine|Intravenous NAC therapy (6.25 mg/kg/hour of 10 mg/ml solution, or 0.625 ml/kg/hour, to give 150 mg/kg/day), starting within 24 hours of completion of KP and lasting for a total of 7 days
15919825|NCT03499223|Drug|Ranibizumab 0.5mg|3 intravitreal injections of ranibizumab 0.5mg, approximately 1 month apart
15919826|NCT03499223|Drug|THR-317 8mg|3 intravitreal injections of THR-317 8mg, approximately 1 month apart
15919827|NCT03499223|Drug|Sham injection|3 sham injections, approximately 1 month apart. No actual injections. No medication is used.
15919829|NCT03499197|Diagnostic Test|cardiac magnetic resonance imaging|Detailed and regular CMR examination (LGE, stress perfusion, T1, T2 mapping)
15919830|NCT03499184|Dietary Supplement|P Flor locally delivered|Locally delivered Lactobacillus reuteri 1.2 CFU per gram
15919831|NCT03499184|Dietary Supplement|P Flor systemically administered|Systemically administered Lactobacillus reuteri 1.2 CFU per gram
15919832|NCT03499184|Drug|Amoxil 500 mg Oral Capsule|Systemically administered Amoxil 500 mg thrice daily
15919833|NCT03499184|Drug|Flagyl 400 mg Tablet|Systemically administered Metronidazole 400 mg twice daily
15919834|NCT03499171|Drug|Citalopram 20mg|Citalopram is taken once a day as an add-on to PPI treatment (2x/d).
15919835|NCT03499171|Drug|Placebo Oral Tablet|Placebo is taken once a day as an add-on to PPI treatment (2x/d)
15919836|NCT03499158|Other|nerve conduction study|nerve conduction study
15919837|NCT03499145|Device|Ophthalmology diagnostic system.|An artificial intelligence to make comprehensive evaluation and treatment decision of ocular diseases.
15919838|NCT03499132|Procedure|anesthesia|Different anesthetic procedures
15919839|NCT03499119|Drug|AMG 334 Dose 1|"Subjects weighing less than weight threshold at Day 1 will be randomized to either Dose 1 or Dose 3.
~Subjects weighing weight threshold or more at Day 1 will be randomized to either Dose 1 or Dose 2"
15919840|NCT03499119|Drug|AMG 334 Dose 2|Subjects weighing weight threshold or more at Day 1 will be randomized to either Dose 1 or Dose 2.
15919841|NCT03499119|Drug|AMG 334 Dose 3|Subjects weighing less than weight threshold at Day 1 will be randomized to either Dose 1 or Dose 3.
15919842|NCT03499106|Drug|IW-1973|Oral Tablet
15919843|NCT03499106|Drug|Itraconazole|Oral Capsule
15919844|NCT03499093|Other|OES|"The first seven items of OES refer to face, facial profile, mouth, teeth alignment, teeth form, teeth color and gums. They are combined into an OES summary score ranging from 0 to 70. The eight item of OES is an overall impression item and is not included in the summary score.
~Internal Consistency was determined using Cronbach's alpha and inter-item correlation for the OES scores (n=140).
~Test-Retest Reliability was assessed using Intraclass Correlation Coefficient. Patients with prosthetic needs (n=20 PP-E subjects and n=15 PP-NE subjects) completed twice the OES-F at an interval of two weeks.
~Convergent validity was assessed by comparing mean OES summary scores evaluated by participant of the esthetic group (PP-E, n=35) and by an expert group. Expert OES score were based on three photographs of each participant.
~Discriminative validity was tested by comparing the OES summary scores using a one-way ANOVA and Scheffe post hoc test."
15919845|NCT03499080|Behavioral|Medication free treatment|Inpatient unit dedicated to medication free treatment. This is an inpatient treatment unit for voluntary, planned treatment. The unit is staffed for a patient group that can be managed within a regime of open doors, voluntary treatment and low supervision. This means that high suicidal risk, severe acting out, active drug abuse etc. is excluded. They have an 8 week treatment program including Illness managment an recovery (IMR), Feedback informed treatment (FIT) and Affect consciousness treatment (ABT).
15919846|NCT03499080|Behavioral|Treatment as usual Myrvegen|Inpatient unit on a different location from the others. Same Level of care. Different treatment program. Intermediate treatment duration (mainly 4-6 weeks).
15919847|NCT03499080|Behavioral|Treatment as usual Åråsen|Unit colocated with the medication free unit. Similar treatment program. Short treatment duration (average 3 weeks).
15919848|NCT03499067|Device|Test lens|Contact lens
15919849|NCT03499067|Device|Control lens|Contact lens
15919850|NCT03499054|Other|Breathing exercises|During hemodialysis, the participants in the exercise group are asked to keep ttheir muscles relaxed, breathe normally through the nose at a rate of 3-8 times per minute with each breath held over 5 seconds in length. At the same time, the particpants are asked to also perform lower leg lifts for about 8 seconds per lift. The exercise is performed for 15-20 minutes, and after resting, blood pressure, oxygen saturation and HRV are measured.
15919851|NCT03499041|Drug|LY3314814|Administered orally
15919852|NCT03499028|Other|JointCOACH|Patients randomized to this group will utilize JointCOACH to communicate with their surgical team, receive information
15919853|NCT03499015|Procedure|Balloon Eustachian Tuboplasty (BET)|A balloon catheter is used to dilate the cartilage part of the eustachian tube and is inserted through the nose to reach the opening of the tube, located in the nasopharynx.
15919854|NCT03499002|Other|Simulated Learning Environment|Intervention is the environment in which the medical student will learn to practice how to suture. The end goal is to determine the impact each environment has on their ability to learn the skill.
15919855|NCT03498989|Other|preterm formula milk|"A. complete blood picture
~B. C-reactive protein
~C. Serum electrolytes
~D. Plain x-ray and abdominal ultrasound."
15919856|NCT03498989|Other|exclusive breast milk|exclusive breast milk
15919857|NCT03498976|Procedure|pulsed radiofrequency|Echoguided technic
15919858|NCT03498963|Procedure|bronchoalveolar lavage|Carrying out a bronchoalveolar lavage (BAL) within 24 hours after admission to intensive care with analysis on standard and specific culture media of environmental germs, carrying out antibiograms, DNA extraction, amplification by universal 16 and 18S rDNA primers followed by high flow sequencing and phylogenetic analysis of pathogens found. Comparison of these results with the same analyses performed on seawater samples taken near the drowning site and during a new AML at 72h for patients still intubated and showing signs of pneumonia in order to determine if the pathogens detected at the entrance persist and are present in the environment.
15919859|NCT03498950|Other|laser therapy|laser irradiation on the taste papillae
15919860|NCT03498937|Device|Active tDCS|10 active tDCS sessions (2 sessions/day for 5 days, 30 min each, 2 mA) applied to the dlPFC
15919861|NCT03498937|Device|Sham tDCS|10 sham tDCS sessions (2 sessions/day for 5 days, 30 min each, 0 mA) applied to the dlPFC
15919862|NCT03498924|Diagnostic Test|Measure of biomarkers in serum and endometrial tissue|Blood sample and endometrial sample
15919863|NCT03498911|Procedure|Mucogingival surgery|The gingiva around the mucosal recession at implant site will be coronally positioned by releasing the underlying mucosa
15919864|NCT03498898|Other|Chronic use of Beta adrenergic receptor blocker|Chronic use of Beta adrenergic receptor blocker
15919865|NCT03498885|Procedure|Low ligation|Left colic artery (LCA) is identified, Tie the sigmoid artery and superior rectal artery, Apical lymph node dissection with the left colic artery preservation is performed.
15919866|NCT03498885|Procedure|High ligation|The IMA is ligated and divided at 2 cm from its origin. Apicallymph nodes dissection is performed.
15919896|NCT03498690|Behavioral|Integrative|Stakeholder groups: a-b
15919867|NCT03498872|Device|AMPfoot 4.0|The novel prosthetic device, i.e. AMPfoot 4.0, was tested during walking in amputees. A dual-task was conducted and non-invasive electro-encephalography was used to investigate neural dynamics.
15919868|NCT03498872|Other|No intervention|The control group included healthy subjects. Comparisons were made between amputees and able-bodied individuals.
15919869|NCT03498859|Other|Physiotherapist-supervised training|The intervention is physiotherapist-supervised training once per week during 10 weeks.
15919870|NCT03498859|Other|Home-based training|The intervention is home-based training during 10 weeks
15919871|NCT03498846|Procedure|Modified EA and AMLK|Two pieces of corneal epithelial tissue with 2mmx3mm will be obtained from the fellow eye using femtosecond laser technology. This epithelial autograft (EA) is then ready for transplantation on the disease eye, following the procedure of allogeneic middle lamellar keratoplasty (AMLK).
15919872|NCT03498846|Procedure|LA and AMLK|A 3-clock-hour limbal autograft (LA) will be obtained from the fellow eye. This is then ready for transplantation on the disease eye following the procedure of AMLK.
15919873|NCT03498833|Other|Test-retest reliability testing|Set of patient reported outcome measures
15919874|NCT03498820|Device|Analgesia Nociception Index|: Non invasive monitor based on heart rate variability analysis, assessing the parasympathetic nervous activity
15919875|NCT03498820|Drug|Remifentanil|intravenous short-acting opioid routinely administered during general anesthesia
15919876|NCT03498807|Device|Ventiltor P/V Loop|determine the Optimal PEEP and keep 48hr on ARDS patients
15919877|NCT03498807|Device|Electrical Impedance Tomography|determine Optimal PEEP and keep 48hr on ARDS patients
15919878|NCT03498794|Procedure|Ureteral stent|"Patients will be randomized into 2 groups:
~Group (A): 75 patients with the use of ureteral stent. Group (B): 75 patients with the use of PCN.
~How the technique will be applied?
~Technique of ureteral stent insertion:
~The ureteral stent will be inserted retrograde by using flexible cystoscope.
~Technique of PCN insertion:
~Percutaneous nephrostomy will be performed in the angiography suite by a urologist with the patient under local anesthesia. All the patients will be given non-nephrotoxic antibiotics pre-operatively."
15919879|NCT03498781|Other|Exercise-only|Participants will write goals related to exercise, the most desired outcome of reaching their goals, anticipated obstacles/barriers which may prevent them from achieving their goals, and if-then statements proactively describing how to overcome or avoid obstacles.
15919880|NCT03498781|Other|Control|Participants will be asked to identify stress-reduction techniques which they can use in their daily lives and will be encouraged to practice them as necessary.
15919881|NCT03498768|Other|Questionnaire Administration|Subjects will be invited to complete a detailed questionnaire regarding personal information, known risk factors for lung cancer and psychological status.
15919882|NCT03498755|Behavioral|Mobile phone audio messaging|"Audio messages will be pushed to participants' mobile phones twice weekly on a set schedule in discrete modules that include basic information related to each of the four behavioral domains followed by an integration of the information across behaviors through relatable, character-driven narratives that enable message recipients to engage with the content through a real-world context."
15919883|NCT03498755|Behavioral|Peer-to-peer learning|Women participants in each community will meet twice monthly for peer-to-peer learning sessions to reinforce the content of audio messages. These sessions will further use women's empowerment approaches including critical examination of gender dynamics, and discussions of solutions for equitable decision-making and control of resources within households. These discussions will be facilitated with male household members and grandmothers in separate learning sessions that will be held three times throughout the intervention period.
15919884|NCT03498755|Behavioral|Conditional cash transfer|Participants will receive a conditional cash transfer to support their fish smoking business. The payment will be conditional on their participation in entrepreneurship trainings and the use of the investment into their fish smoking business.
15919885|NCT03498755|Behavioral|Entrepreneurship training|Entrepreneurship training will focus on commonly lacking business knowledge, with an emphasis on establishing fundamental entrepreneurial skills (i.e., customer care, accounting), sound business management and decision-making, building strong and sustainable business relationships, and encouraging the use of loans for their intended purposes. This training will be introduced during the credit and savings group (CSG) meetings that will occur twice per month.
15919886|NCT03498755|Behavioral|Market price information|Average market prices for fresh and processed fish at community, district, and regional markets will be disseminated via audio message calls (using Viamo's Infoline platform) to the mobile phones of women with the price information in their preferred language. These market prices will be collected twice weekly by Viamo field enumerators and sent to regional coordinators for validation. A second, independent validation will be carried out to ensure that there are no discrepancies.
15919887|NCT03498755|Behavioral|Improved smoke ovens|Local private sector artisans will construct and serve as suppliers of the new ovens. The promotion, uptake and impact of these improved Ahotor ovens will be tested among study participants. Awareness-raising workshops held in each community will promote the Ahotor in concert with a public retrofitting of a Chorkor stove. Immediately following this event, one month later, and three months later, study participants will receive additional one-on-one counseling to provide further support on the proper use of the smoke oven, as well as on optimal handling and smoking practices to enhance product quality.
15919888|NCT03498742|Other|NO Intervention|Routine clinical data; asthma control test and spirometry
15919889|NCT03498729|Other|Peripheral Blood Sample|30mL peripheral whole blood sample
15919890|NCT03498716|Drug|Atezolizumab|"Atezolizumab will be administered by IV, 840 mg every 2 weeks, for 10 doses.
~Atezolizumab maintenance will be administered by IV, 1200 mg every 3 weeks to complete 1 year"
15919891|NCT03498716|Drug|Paclitaxel|Paclitaxel will be administered by IV, 80 mg/m^2 every week for 12 weeks.
15919892|NCT03498716|Drug|Dose-dense Doxorubicin or dose-dense Epirubicin|"Dose-dense doxorubicin will be administered by IV, 60 mg/m^2 every 2 weeks for a total of 4 doses.
~Or
~Dose-dense epirubicin will be administered by IV, (90 mg/m^2) every 2 weeks for a total of 4 doses"
15919893|NCT03498716|Drug|Cyclophosphamide|Cyclophosphamide will be administered by IV, 600 mg/m^2 every 2 weeks for 4 doses
15919894|NCT03498703|Drug|Azathioprine Pill|Azathioprine increase pregnancy rate in cases with recurrent implantaion failure
15919895|NCT03498703|Drug|Placebo Oral Tablet|Placebo tablets
15919901|NCT03498664|Device|cap for mucosectomy|endoscopic mucosal resection of colonic lesions with a plastic cap for mucosectomy
15919902|NCT03498664|Device|standard snare for polypectomy|endoscopic mucosal resection of colonic lesions with standard inject and cut mucosectomy
15919903|NCT03498651|Behavioral|Cognitive Bias Modification - Interpretation training|Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will typically then assign a benign (rather than threatening) meaning to the scenario.
15919904|NCT03498651|Behavioral|Coaching|Participants identified as high risk for attrition will receive low-intensity coaching, which includes a mix of brief phone calls, texts, and/or emails with a trained member of the study team to help address challenges with adherence to and application of the training.
15919905|NCT03498651|Behavioral|Online psychoeducation about anxiety|Participants will review webpages that describe information about symptoms and causes of anxiety, including the nature of biased thinking in anxiety.
15919906|NCT03498638|Behavioral|Couples Therapy|Couples in the intervention group will receive couples therapy for 8 weekly sessions. Each therapy session will last approximately an hour. All therapies will be conducted by the PI, Dr. Gunnur Karakurt. Dr. Karakurt is a Licenced Marriage and Family Therapist and AAMFT (American Association of Marriage and Family Therapy) approved clinical supervisor. All therapies will be conducted as a couple. Training on stress management and safety planning will be performed as individuals. There will not be any group sessions. The goal of couple therapy is to help and improve couples' capacity to regulate emotions, solve problems, and communicate through therapy with the couple together.
15919907|NCT03498638|Other|Control|Couples in the control group will be taught safety planning, given information on local resources to help victims of violence, and will be instructed in stress and anger management strategies. Following this 8 week period, they will receive 8 weeks of couple therapy unless they choose not to.
15919908|NCT03498625|Diagnostic Test|Colonoscopy|Colonoscopy for CD patients in clinical remission
15919909|NCT03498612|Other|Laboratory Biomarker Analysis|Correlative studies
15919910|NCT03498612|Biological|Pembrolizumab|Given IV
15919911|NCT03498599|Behavioral|Novelty facilitated extinction|In the novelty-facilitated extinction design, the aversive outcome (i.e., mild unpleasant electrical pulse) is omitted and replaced by a low volume auditory tone.
15919912|NCT03498599|Behavioral|Standard Extinction|During standard fear extinction the expected aversive outcome is omitted.
15919913|NCT03498586|Drug|Half-normal saline|Use of half-normal saline as an irrigant for open-irrigated ablation catheters
15919914|NCT03498586|Drug|Normal saline|Use of normal saline as an irrigant for open-irrigated ablation catheters
15919915|NCT03498573|Other|tunneling surgical technique|sticky bone prepared by centrifuge patient blood and mixing with xinograft
15919916|NCT03498560|Device|PSG|PSG data to be collected on the night before surgery to establish level of preexisting sleep disturbance.
15919917|NCT03498547|Procedure|caudal block|For the caudal block, sacral horns are palpated and sacral hiatus and epidural area will be determined at S4-S5 level through ulştrasonography. The 20 G adult caudal needle will then be placed to the caudal epidural space and 25 mL bupivacaine at a concentration of 0.5% will be applied in the prone Jack-Knife position with resistance loss.
15919918|NCT03498547|Procedure|saddle block|In the saddle block group hyperbaric bupivacaine at a dose of 7 mg will be given to the intrathecal space after a 25 G quincke spinal needle is inserted with ultrasonographyguidance between L4-L5 vertebral disc and clear cerebrospinal fluid is seen. The patient will be placed in sitting position for 5 minutes.
15919919|NCT03498534|Drug|Isoniazid 300Mg Tab|-TST tests will receive isoniazid 300Mg Tab for 6 months
15919920|NCT03498534|Drug|Isoniazid 300 MG|+ TST test will receive isoniazid 300MG Tab for 6 months
15919921|NCT03498534|Drug|Isoniazid 300 MG|HIV positive patient will receive isoniazid 300MGTab for 6 months
15919940|NCT03498495|Behavioral|Self-Monitoring Activity-restriction and Relaxation Training (SMART)|SMART integrates real-time self-monitoring of symptoms and activities with interactive modules designed to increase self-efficacy through psychoeducation and training in problem solving/problem-focused coping strategies.
15919941|NCT03498482|Behavioral|Narrative Exposure Therapy for Forensic Offender Rehabilitation (FORNET)|FORNET aims to reduce trauma-related symptoms and aggressive behavior via narrative exposure of traumatic and violent life events.
15919942|NCT03498469|Behavioral|Standardized reintegration package|Participants assigned to this comparison arm will receive a standardized reintegration package that includes individualized case management support and a reunification cash grant Individualized case management will consist of a caseworker-developed individualized care plan with routine caseworker visits at the household level. Home visitation will begin during the family assessment and preparation stages and continue throughout the 15-month post-reunification follow-up period. For the cash grant, the family of each enrolled child will receive a reunification cash grant in the Ugandan Shilling equivalent of $125, administered in two equal disbursements. It is designed to offset the cost of child care.
15919943|NCT03498469|Behavioral|Enhanced reintegration package|Participants assigned to this arm will receive an enhanced reintegration package that consists of the parenting program, individualized case management, and the reunification grant. will be delivered at the household level by project trained parenting facilitators. The program will consist of approximately 13 bi-weekly sessions, which will be delivered over the course of 7 months. The individualized case management and the reunification grant will be similar to those in the comparison arm.
15919944|NCT03498456|Drug|Tegoprazan/Amoxicillin/Clarithromycin|Tegoprazan 50 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg bid. This therapy will be administered for a total of 7 days, in fasting conditions in the morning and the evening.
15919945|NCT03498456|Drug|Lansoprazole/Amoxicillin/Clarithromycin|Lansoprazole 30 mg + Amoxicillin 1000 mg + Clarithromycin 500 mg bid. This therapy will be administered for a total of 7 days, in fasting conditions in the morning and the evening.
15919946|NCT03498430|Drug|Copanlisib (Aliqopa, BAY80-6946)|Copanlisib will be administered intravenously on 60mg once in a 3 weeks-on/1 week-off dose regimen (on Days 1, 8 and 15)
15919947|NCT03498417|Diagnostic Test|Serum antibodies against the IGF-1R|Measurement of antibodies against the IGF-1R in serum samples by ELISA
15919948|NCT03498404|Radiation|Photodynamic Therapy|After the sites are indicated for surgical therapy, they receive surgical access therapy associated with scaling and root planing and TfdA using the treatment protocol during periods of 0, 7, 14 and 30 postoperative days, or only surgical access therapy associated with scaling and root planing. As protocol, TfdA will be used laser light source 660nm wavelength in combination with phenothiazine, a photosensitizer with 10 seconds of exposure per site during surgery and 60 seconds in other applications.
15919949|NCT03498404|Other|scaling and root planing|Scaling and root planing, also known as conventional periodontal therapy, or deep cleaning, is a procedure involving removal of dental plaque and calculus (scaling or debridement) and then smoothing, or planing, of the (exposed) surfaces of the roots, removing cementum or dentine that is impregnated with calculus, toxins, or microorganisms, the etiologic agents that cause inflammation. This helps to establish a periodontium that is in remission of periodontal disease. Periodontal scalers and periodontal curettes are some of the tools involved.
15919950|NCT03498391|Drug|Propofol|Titration of propofol to minimal and moderate sedation as measured by Richmond Agitation-Sedation Scale with behavioral task performance over several hours.
15919951|NCT03498391|Drug|Ketamine Injectable Product|Titration of ketamine to minimal and moderate sedation as measured by Richmond Agitation-Sedation Scale with behavioral task performance over several hours.
15919952|NCT03498378|Drug|Avelumab|Avelumab (IV on days 1 and 15 of 28 day cycle)
15919953|NCT03498378|Drug|Palbociclib|"Palbociclib (PO daily, days 1-21 of 28 day cycle)
~Palbociclib will be administered in capsules of 125 mg, 100 mg, and 75 mg, depending on dosage. Patients will be instructed to take their assigned dose once daily with food for 21 days followed by 7 days off therapy. Patients will be encouraged to take their dose at approximately the same time each day."
15919954|NCT03498378|Drug|Cetuximab|"Cetuximab (IV 400 mg/m2 x 1, then weekly)
~Cetuximab is administered intravenously once weekly via infusion pump or syringe pump with infusion rate not to exceed 10 mg/min."
15919955|NCT03498365|Behavioral|MCDA|Experimental decision support
15919956|NCT03498365|Behavioral|Delphi|Standard support
15919957|NCT03498352|Procedure|Thoracic surgery|Lung resection surgery
15920105|NCT03497221|Behavioral|Visual identity campaign|The same description of arm Visual identity campaign.
15919958|NCT03498326|Drug|Gemcitabine|One group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection at 1000mg/m2.
15919959|NCT03498326|Drug|Gemcitabine|the other group patients receive the standard gemcitabine treatment at 1,8,15 of the chemotherapy cycle after R0 resection at 1000mg/m2, and receive additional celecoxib 200mg bid every days during chemotherapy period.
15919960|NCT03498313|Drug|Transdermal Estradiol + Placebo|.1mg/24hr transdermal estradiol for 14 days starting day 7 after positive urine luteinizing hormone test, plus twice daily placebo pills during the same time frame.
15919961|NCT03498313|Drug|Oral Micronized Progesterone + Placebo|100mg oral micronized progesterone twice daily for 14 days starting day 7 after positive urine luteinizing hormone test, plus weekly application of a placebo patch during the same time frame.
15919962|NCT03498313|Drug|Placebos|Twice daily placebo pills for 14 days starting day 7 after positive urine luteinizing hormone test, plus weekly application of a placebo patch during the same time frame.
15919963|NCT03498300|Biological|Tdap vaccine|A single dose of Tdap vaccine at GA 27 - 36 weeks
15919964|NCT03498287|Device|Study Device|Real study device applied to affected wrist (or higher CTS severity wrist if patient has bilateral CTS) for 8-10 hours daily for 56 days (8 weeks).
15919965|NCT03498287|Device|Sham Device|Sham device applied to affected wrist (or higher CTS severity wrist if patient has bilateral CTS) for 8-10 hours daily for 56 days (8 weeks). *Note: participants in the sham group are given the real study device at the end of the Post-Treatment/Follow-up Phase.
15919966|NCT03498274|Device|Fitting System|End users will drive the screening and fitting flow; however, a trained professional is intended to assist them and help with explanations and the actual fitting of the hearing aids on the person. For a first time user the physical act of placing the hearing aid in/on the ear may create confusion. Therefore, the software is designed for an assistant to guide the user through the process and help with specific parts of the fitting or any questions in general.
15919967|NCT03498274|Device|Traditional Fitting System|The trained professional will fit the hearing aids with the traditional software that is currently used on the market. They will not involve the patient except to play demonstration tones.
15919968|NCT03498261|Drug|Gabapentin|Gabapentin has been commonly used as an adjuvant in the treatment of neuropathic pain.
15919969|NCT03498261|Drug|Placebos|Placebo
15919970|NCT03498248|Drug|lenograstim|injection of lenograstim in patients with neutropenia after cytotoxic chemotherapy
15919971|NCT03498235|Drug|Sevoflurane|In Team Sevoflurane,patients undergo sevoflurane.
15919972|NCT03498235|Drug|Propofol|In Team Propofol ,anesthesia is maintained with propofol
15919973|NCT03498222|Drug|Atezolizumab|Administered at a fixed dose of 1200 mg (equivalent to an average body weight-based dose of 15mg/kg) by intravenous (IV) infusion every 3 weeks (21 days).
15919974|NCT03498222|Drug|Pemetrexed|Administered at a fixed dose of 500mg/m2 by IV infusion every 3 weeks.
15919975|NCT03498222|Drug|Carboplatin|Administered at a fixed dose of AUC5 by IV infusion every 3 weeks.
15919976|NCT03498222|Drug|ADI PEG20|Administered by intramuscular (IM) injection to patients once weekly.
15919977|NCT03498196|Drug|Avelumab|avelumab 10 mg/kg intravenously every 2 weeks for 3 cycles or 42 days.
15919978|NCT03498183|Drug|MIBI-Tc99m/Iodine-123|Following the injection of MIBI-Tc99m/Iodine-123 , the patients will have a scintigraphy.
15919979|NCT03498170|Drug|BCT197|Single dose of BCT197
15919980|NCT03498170|Drug|Itraconazole 200 mg|Single dose of itraconazole
15919981|NCT03498157|Behavioral|Exercise|The exercise intervention is an at least 2 weeks lasting (till the day surgery is taking place) 5-times weekly resistance training intervention combined with aerobic exercise (mostly walking).
15919982|NCT03498157|Behavioral|Prehabilitation Education|Participate will receive a 2 hour group-based prehabilitation class which will be held at the Penn State Cancer Institute, Hershey
15919983|NCT03498144|Device|Anterior segment OCT|lower punctum examination by AS-OCT
15919984|NCT03498131|Drug|3 mg Melatonin|3 mg melatonin once each day
15919985|NCT03498131|Drug|5 mg Melatonin|5 mg Melatonin once each day
15919986|NCT03498118|Drug|20 mL of bupivacaine 0.25%|"In the infiltration group, at the end of surgery, 30 mL of bupivacaine 0.25% was injected subcutaneously in the surgical wound (15 mL in each of the upper and lower sides) by the obstetrician before skin closure. Sam procedure was performed by the primary investigator after completion of surgery by pressing a covered spinal needle on both sides of the patient's abdomen.
~In the TAP group, after completion of surgery, 20 mL of bupivacaine 0.25% was injected under direct visualization in the plane between the transversus abdominis muscle and the fascia deep to the internal oblique muscle on each side."
15919987|NCT03498092|Drug|Bupivacaine-Dexmedetomidine|isobaric bupivacaine 2.5 mg/ml plus 5 micro gram/ml adrenaline and 1 micro gram/kg dexmedetomidine in a volume of 0.5 ml/kg
15919988|NCT03498092|Drug|Bupivacaine|isobaric bupivacaine 2.5 mg/ml plus 5 micro gram/ml adrenaline in a volume of 0.5 ml/kg
15919989|NCT03498092|Drug|General anesthesia|Normal saline in a volume of 0.5 ml/kg
15919990|NCT03498079|Diagnostic Test|3D ultrasound|3D ultrasound will be done to females complaining from primary infertility with mullerian anomalies
15919991|NCT03498066|Drug|Beta-blockers withdrawal|withdrawal of all type of betablockers
15919992|NCT03498066|Drug|Continuation of the Betablockers (βB) treatment|Use Betablockers treatment
15919993|NCT03498053|Behavioral|Marlboro|Participants smoke Marlboro during the first experimental day, ad libitum.
15919994|NCT03498053|Behavioral|Marlboro Prime|Participants smoke Marlboro Prime during the second experimental day, ad libitum.
15919995|NCT03498053|Behavioral|Marlboro Prime (ventilation holes taped)|Participants smoke Marlboro Prime (filter ventilation holes taped) during the third experimental day, ad libitum.
15919996|NCT03498040|Other|Study of the occurrence of Carcinoid Heart Disease|"Patient at high risk of Carcinoid Heart Disease (metastatic ileum or bronchial well-differentiated neuroendocrine tumors, patients with high level of urinary 5HIAA or with carcinoid syndrome) are followed with annual echocardiography to detect the occurrence of carcinoid heart disease.
~In case of documented Carcinoid Heart Disease, a six or three months' cardiac follow-up is necessary to evaluate the progression and the severity of the disease.
~Investigators collect the data of clinical parameters (flushes, diarrhea, …) biological parameters (urinary 5HIAA, NT-ProBNP …) and cardiac parameters that may influence the occurrence, severity and progression of Carcinoid Heart Disease."
15919997|NCT03498027|Device|TaqMan Bacillus anthracis Detection Kit|The TaqMan® Bacillus anthracis Detection Kit is composed of the Applied Biosystems® 7500 Fast Dx Real-Time PCR Instrument with SDS Software, secondary interpretative software, and lyophilized reagents for the detection of gene targets for B. anthracis. The test assay is a multiplexed assay targeting gene targets for B. anthracis, in addition to an internal positive control. Reagents are lyophilized as a fully formulated Mastermix and are stable at room temperature for up to two years. The kit is specifically designed for performing real-time PCR using the Applied Biosystems® 7500 Fast Dx Real-Time PCR Instrument with SDS Software , with nucleic acids extracted from clinical specimens using Qiagen's QIAamp® Blood Midi Kit manual extraction or Roche MagNAPure automated extraction methods.
15919998|NCT03498014|Other|Pharmacogenetic analysis allowing personalized opioid prescription|Genotypic of patient to determine optimal opioid treatment (tramadol, codeine or oxycodone)
15919999|NCT03498014|Other|Standard opioid prescription|Opioid prescription made without reference to patient genetic profile (tramadol, codeine or oxycodone)
15920000|NCT03498001|Drug|Liraglutide|6 mg/ml
15920001|NCT03498001|Procedure|Cardiac MRI|T3 myocardial MRI (total acquisition time : 1h) performed before initiation of treatment and measuring the concentration of intramyocardial triglycerides ([TG] by NMR spectroscopy, parameters of cardiac morphology (myocardial mass, (epicardial fat surface, pericardial fat surface), function (LVEF, SV, TDV, PFR, TPFR) and tissue parameters (extracellular volume, left myocardial fibrosis volume).
15920002|NCT03498001|Other|Follow up by phone|at 2 and 4 mois
15920003|NCT03497988|Drug|Syntocinon|The active substance of Syntocinon is a synthetic nonapeptide identical to the posterior pituitary hormone oxytocin.
15920004|NCT03497988|Drug|Placebo|The placebo is identical to the Syntocinon formulation with the exception of the active compound, i.e., without oxytocin.
15920005|NCT03497975|Drug|Nalbuphine ER Tablets|Active Nalbuphine ER Tablets
15920006|NCT03497975|Other|Matching Placebo Tablets|Matching Tablets with no active substance
15920007|NCT03497962|Procedure|Venepuncture|Taken from established arterial or central lines in critical care setting or by experienced clinicians if no line available and in healthy volunteers.
15920008|NCT03497962|Procedure|Bronchoscopy|Broncho-alveolar lavage to obtain alveolar macrophages
15920009|NCT03497936|Behavioral|Women's Stories|Women's Stories is a brief, HPV vaccination promotion intervention. It presents vaccine information and videos of HPV vaccine decision making. It also includes follow up vaccine reminder text messages.
15920010|NCT03497923|Drug|Magnesium Sulfate|After reversal the obention of a TOF ratio of 0.9 is avaited. 10 minutes later patients will receive a perfusion of magnesium 60 mg kg-1 over 5 minutes.
15920013|NCT03497884|Device|rTMS|For the l-Hz sessions (low frequency), stimulation is delivered at 100% of the subject's resting motor threshold at 1 Hz continuously over 30 min for a total of 1,800 pluses. The 10-Hz stimulation (high frequency) is delivered at 100% of the subject's resting motor threshold via 60 trains of 3-s 10-Hz rTMS (30 pulses per train).
15920014|NCT03497871|Device|HeartMan system|The HeartMan system uses wristband sensors to monitor patients' physical activity and physiological parameters. These data are connected to a decision support system, providing medical advice to patients concerning physical exercise, nutrition, medication intake, clinical measurements, environment management, and mental support. The decision support system is based on predictive models, clinical care guidelines and expert knowledge. The advice will be personalized according to each individual patient's medical and psychological profile, and will be presented to the patient through the user interface of a mobile application on a smartphone.
15920015|NCT03497858|Other|Coconut Water|participants will consume coconut water and complete a simulated basketball game
15920016|NCT03497858|Other|Placebo - water|participants will consume Placebo - water and complete a simulated basketball game
15920017|NCT03497858|Other|Sports drink|participants will consume a sports drink and complete a simulated basketball game
15920018|NCT03497845|Biological|VN|0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
15920019|NCT03497845|Biological|IN|0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
15920020|NCT03497845|Biological|dk/BANG|0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
15920021|NCT03497845|Biological|gf/WA|0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
15920022|NCT03497845|Biological|bhg/QL|0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
15920023|NCT03497845|Biological|AS03 adjuvant|0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
15920024|NCT03497845|Biological|MF59 adjuvant|0.5 mL vaccine (H5 vaccine antigen plus adjuvant) per dose
15920025|NCT03497832|Other|magnetic resonance spectroscopy (MRI)|Each healthy subject will get 3 MRI examinations at 7:30, 13:30 and 18:00. Each MRI scan lasts an average of 20 minutes.
15920026|NCT03497819|Biological|CARTmeso CART19|Autologous chimeric antigen receptor T cells with murine scFv, 41BB co-stimulatory domain and CD3ζ signaling domain targeting mesothelin or CD19
15920027|NCT03497806|Biological|CP101|Study drug will be administered at Treatment (Day 1) as an oral dose after cessation of standard-of-care CDI antibiotic treatment of the current episode of recurrent CDI.
15920028|NCT03497793|Other|SNUBY|Following written informed consent, mother will be issued with an appropriate sized SNUBY® for her use only. The infant will be placed in skin-to-skin in SNUBY®, infant chest to mother's chest whilst the mother is seated on a reclining chair, allowing the infant to be further stabilised by gravity. Monitor wires, IV lines and/or ventilation tube will be secured using the ties on the SNUBY®. The infant's temperature, pulse and SaO2 will be recorded prior to skin-to-skin, repeated as required for the infant's clinical condition or at 30min intervals for the duration of skin-to-skin. Maternal and infant behaviour will be recorded, including spontaneous breastfeeding. The time taken to put the infant into skin-to-skin care, time in skin-to-skin care and time to return to cot will be recorded.
15920029|NCT03497780|Procedure|Anterior cruciate ligament reconstruction|Primary surgical reconstruction of the rupture anterior cruciate ligament
15920030|NCT03497767|Drug|Osimertinib|All participants will receive a dose of Osimertinib 80mg once daily
15920031|NCT03497767|Radiation|Stereotactic Radiosurgery (SRS)|Dose and fractionation depend on lesion size. All SRS must be completed within 21 days of randomisation and all lesions are to be treated within 7 days.
15920032|NCT03497754|Device|Probefix|A passive leg raising test will be done twice to assess the fluid response. Changes in cardiac output are measured using TTE with and without the use of the Probefix.
15920033|NCT03497741|Diagnostic Test|procalcitonin measurement|For each patient were blood cultures were taken, a procalcitonin level was determined
15920034|NCT03497715|Drug|Ibuprofen lysine|Test 1
15920035|NCT03497715|Drug|Ibuprofen Sodium|Test 2
15920036|NCT03497715|Drug|Ibuprofen|Test 3
15920037|NCT03497715|Drug|Ibuprofen (Nurofen)|Reference 1
15920038|NCT03497715|Drug|Ibuprofen (Wockhardt)|Reference 2
15920039|NCT03497702|Drug|Doxorubicin|60mg/m2 IV every 3 weeks for 4 cycles
15920040|NCT03497702|Drug|Cyclophosphamide|600mg/m2 IV every 3 weeks for 4 cycles
15920041|NCT03497702|Drug|Docetaxel|75mg/m2 IV every 3 weeks for 4 cycles
15920042|NCT03497702|Drug|Letrozole|2.5 mg once daily preoperably
15920043|NCT03497702|Drug|leuprorelin|3.75 mg SC every 4 weeks for premenopausal patients
15920044|NCT03497689|Drug|Intravenous/Subcutaneous Treprostinil; Oral Treprostinil|Short term course of IV/SC treprostinil continuous infusion followed by transition to oral treprostinil extended-release tablets taken three times daily
15920045|NCT03497676|Drug|Oral Cabotegravir (CAB)|30 mg tablets administered orally
15920046|NCT03497676|Drug|Oral Rilpivirine (RPV)|25 mg tablets administered orally
15920047|NCT03497676|Drug|Long-Acting Injectable Cabotegravir (CAB LA)|Administered by intramuscular (IM) injection
15920048|NCT03497676|Drug|Long-Acting Injectable Rilpivirine (RPV LA)|Administered by intramuscular (IM) injection
15920049|NCT03497676|Drug|Combination Antiretroviral Therapy (cART)|Participants will continue their pre-study cART regimen. The antiretroviral drugs in participants' cART regimens will not be provided through the study.
15920050|NCT03497663|Other|VIA Family intervention|Family based intervention
15920051|NCT03497663|Other|Treatment As Usual|Treatment As Usual
15920052|NCT03497650|Device|Mirror Therapy|Mirror Therapy involved the patient sitting on a chair with a standard mirror placed between both legs with the reflective side of the mirror facing the non-affected leg. The patient is instructed to observe the reflection of the non-affected limb during the sessions. The patient was not given any instruction on the use of the affected limb.
15920053|NCT03497650|Other|Cross-Education of Strengthening.|Cross-education of strengthening involves training one side of the body with the intention of producing strengthening gains on both sides of the body. In this case the strengthening was done on the non-affected leg of each stroke patient.
15920054|NCT03497637|Diagnostic Test|measurement of FFR|use of pressure-derived FFR to assess the hemodynamic significance of coronary stenoses
15920055|NCT03497637|Diagnostic Test|measurement of Pd/Pa|use of resting distal coronary pressure to aortic pressure ratio (Pd/Pa) to assess the hemodynamic significance of coronary stenoses
15920056|NCT03497624|Other|Biospecimens collection|Collection of tumor tissue when a participant is having a clinically-indicated biopsy or surgery for their ROS1-fusion cancer.
15920057|NCT03497611|Procedure|transcatheter valve implantation|aortic transcatheter valve implantation using Edwards SAPIEN 3 valve
15920058|NCT03497598|Drug|Mannose|The powder is dispensed in 2g neutral sticks and ready to be dissolved in 100ml of water for daily oral ingestion.
15920059|NCT03497598|Drug|Lactose|The powder is dispensed in 2g neutral sticks and ready to be dissolved in 100ml of water for daily oral ingestion.
15920060|NCT03497585|Behavioral|Activity pacing framework|The activity pacing framework will be used to structure and standardise the instructions of pacing in existing rehabilitation programmes for adult patients with chronic pain/fatigue. The activity pacing framework has been developed in Stages I and II of this research. Stage I involved an online survey of activity pacing across healthcare professionals in England. The survey findings, together with existing research were used to develop the first draft of the framework. The framework was refined in Stage II: Nominal group technique (consensus method). The activity pacing framework describes the aims, facets and stages of pacing, together with how pacing relates to different behavioural typologies and other pain management strategies.
15920061|NCT03497559|Other|Music|Classical music
15920062|NCT03497546|Other|Exercise|Concurrent (aerobic and strength) supervised exercise program: the program comprises 3 sessions/week (60 min/session) of aerobic and strength exercises of progressive volume and intensity. The program will follow the Consensus on Exercise Reporting Template (CERT) guidelines.
15920063|NCT03497533|Biological|TriCAR-T-CD19|A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously at a target dose of 0.5-1 x 10^6 CAR+ T cells/kg
15920064|NCT03497520|Behavioral|asymmetric spinal stabilization exercise|"The patients were educated to strengthening weakness side of spinal muscle, as asymmetric spinal stabilization exercise(ASSE)
~before teach ASSE, the investigators will evaluate Cobb angle, Apical vertebral rotation in Adam's test, surface EMG, Scoliosis Research Society-22(SRS-22) quastionnaire for evaluation of scoliosis severity
~after perform ASSE, the investigators will evaluate Cobb angle, Apical vertebral rotation in Adam's test, surface EMG, Scoliosis Research Society-22(SRS-22) quastionnaire for evaluation of scoliosis severity"
15920067|NCT03497494|Procedure|2 cm away from the pylorus edge|2 cm away from the pylorus edge
15920068|NCT03497494|Procedure|4 cm away from the pylorus edge|4 cm away from the pylorus edge
15920069|NCT03497494|Procedure|6 cm away from the pylorus edge|6 cm away from the pylorus edge
15920070|NCT03497494|Procedure|LRYGB|laparoscopic Roux-en-Y gastric bypass
15920071|NCT03497481|Biological|Samples|Eye's anterior chamber fluid and urines are sampled for posterior neopterin analysis
15920072|NCT03497468|Other|Combined exercise training|Aerobic training with cycle ergometer %60-80 of maximal Heart Rate, submaximal level, strengthening of the major muscles of upper and lower extremities
15920073|NCT03497468|Other|Task-oriented training|Functional reaching, walking on different obstacles and floor,sitting and standing on different levels and surface,walking around obstacle, climbing stairs with different height and surface
15920106|NCT03497208|Procedure|Microneedling|The technique is about applying a dermaroller equipped with 0.25 mm needles over the vitiligo area.
15920074|NCT03497455|Device|Barco NV Digital Dermatoscope device images|Images taken by Clinician in consultation OR in Dermatology department theatres OR images taken in medical photography suite - in the latter case, images can be taken by medical photographer or Research nurse or Dermatologist
15920075|NCT03497455|Device|Standard medical photographs including dermoscopy images|Images taken by medical photographer as part of standard care in the medical photography suite.
15920076|NCT03497455|Other|Clinic proforma completion|This is part of standard care and will be undertaken by the clinician who is responsible for the patient
15920077|NCT03497442|Drug|Brimonidine Tartrate|Topical brimonidine tartrate will be applied to one half of each participant's face. A randomization process will be used to determine which side of the face each participant will apply treatment to. The untreated side of the face will receive a placebo vehicle. Patient and clinician will be blinded to treatment side.
15920078|NCT03497442|Drug|Placebo Vehicle Gel|Vehicle Gel
15920079|NCT03497429|Drug|Niraparib|Niraparib capsule
15920080|NCT03497416|Other|No intervention|No intervention
15920081|NCT03497403|Procedure|Socket preservation control|After a tooth was extracted, the adjacent gum tissue was fully reflected, bone graft (FDBA) and non-cross-linked barrier membrane (Bio-Gide) were applied to the defect. The site was stabilized with sutures. Patients were followed for 6 months post operatively.
15920082|NCT03497403|Procedure|Socket preservation experimental|After a tooth was extracted, the adjacent gum tissue was minimally reflected, bone graft (FDBA) and cross-linked barrier membrane (OssixPlus) were applied to the defect. The site was stabilized with sutures. Patients were followed for 6 months post operatively.
15920083|NCT03497390|Other|EMERALD intervention|EMERALD consists of a 1-year multi-component structured program led by nurses and held 4-weekly for the first 3 months, followed by maintenance program, peers support and telephone calls.
15920084|NCT03497390|Other|Usual care|Usual care without any workshop or program
15920085|NCT03497377|Drug|18F-DCFPyL Injection|
15920086|NCT03497377|Drug|18F-NaF|
15920087|NCT03497364|Drug|bupivacaine|0.5 % bupivacaine (0.75% bupivacaine (2 ml) + cerebrospinal fluid (1 ml)) was injection according to the height of subjects (1.7 ml for 173~174cm, 1.65 ml for 170~172cm, 1.6 ml for 168~169cm, 1.55 ml for 165~167cm, 1.5 ml for 163~164cm, 1.45 ml for 160~162cm, 1.4 ml for 158~159cm, 1.35 ml for 155~157cm, 1.3 ml for 153~154cm, 1.25 ml for 150~152cm, 1.2 ml for 148~149cm)，1.15 ml for 145~147cm).
15920088|NCT03497364|Drug|ropivacaine|0.5 % ropivacaine (1% ropivacaine (1.5 ml) + cerebrospinal fluid (1.5 ml)) was injection according to the height of subjects (2.300 ml for 173~174cm, 2.225 ml for 170~172cm, 2.15 0ml for 168~169cm, 2.075 ml for 165~167cm, 2.000 ml for 163~164cm, 1.925 ml for 160~162cm, 1.850 ml for 158~159cm, 1.775 ml for 155~157cm, 1.700 ml for 153~154cm, 1.625 ml for 150~152cm, 1.55 0ml for 148~149cm, 1.475 ml for 145~147cm)
15920089|NCT03497351|Drug|Nicardipine|The patients in Group N were infused the 130/0.4 hydroxyethyl starch and sodium chloride injection ( 7 ml/kg, 0.4 ml/kg/min) after anesthesi induction and before skin incision. Then the HR, SAP, DAP, MAP, CO, CI, SV, SVI, PPV and SVV were recorded. When the circulation was stability, Nicardipine was given, and the the 130/0.4 hydroxyethyl starch and sodium chloride injection was infused again.
15920090|NCT03497351|Drug|Urapidil|The patients in Group N were infused the 130/0.4 hydroxyethyl starch and sodium chloride injection ( 7 ml/kg, 0.4 ml/kg/min) after anesthesi induction and before skin incision. Then the HR, SAP, DAP, MAP, CO, CI, SV, SVI, PPV and SVV were recorded. When the circulation was stability, Urapidil was given, and the the 130/0.4 hydroxyethyl starch and sodium chloride injection was infused again.
15920091|NCT03497325|Drug|autologus platelet rich plasma|55 participant unergoing prelabor primary CS will receive intramyometrial injection of PRP after closure of uterine incision
15920092|NCT03497325|Drug|placebo|55 participant unergoing prelabor primary CS will receive intramyometrial injection of normal saline after closure of uterine incision
15920093|NCT03497312|Procedure|full mouth rehabilitation|full mouth rehabilitation under general anesthesia
15920094|NCT03497299|Device|Active rTMS (20Hz)|Repetitive Transcranial Magnetic Stimulation (rTMS) Procedures: On Day 1, participants will be randomly assigned to receive active or sham rTMS using the MagProX100/R30 stimulator equipped with the B65 active/ placebo coil for DLPFC stimulator (MagVenture, Farum, Denmark) for a period of 28 days.
15920095|NCT03497299|Device|Sham rTMS|Repetitive Transcranial Magnetic Stimulation (rTMS) Procedures: On Day 1, participants will be randomly assigned to receive active or sham rTMS using the MagProX100/R30 stimulator equipped with the B65 active/ placebo coil for DLPFC stimulator (MagVenture, Farum, Denmark) for a period of 28 days.
15920096|NCT03497286|Behavioral|Text-based mentorship|The treatment is a text-based peer-to-peer mentorship program for new mothers to promote the healthy development of young children by enhancing the parenting skills of the children's parents. Volunteer mentors who are experienced parents are paired with the parents of newborns. Mentors use text messaging to communicate with, support and encourage new parents while providing best-practice information, answers to the parents' questions, suggestions regarding activities to foster healthy development, and reminders about key milestone activities. The typical NurturePA mentor-mother pair communicates back-and-forth multiple times per week, at any time of the day.
15920097|NCT03497286|Behavioral|Control text messaging|Control participants will receive periodic texts from NurturePA with information about child safety and health.
15920098|NCT03497273|Drug|Itacitinib|Itacitinib administered orally once daily at the protocol-defined dose.
15920099|NCT03497273|Drug|Corticosteroid|Either oral prednisolone or intravenous methylprednisolone at the investigator's discretion.
15920100|NCT03497260|Dietary Supplement|Fructose|Intake of 20 g of fructose dissolved in 200 ml of tap water within 5 minutes 30 minutes prior to exercise.
15920101|NCT03497260|Other|Plain water|Intake of 200 ml of tap water within 5 minutes 30 minutes prior to exercise.
15920102|NCT03497247|Behavioral|Mindfulness-Based Cognitive-Behavioral Therapy|Both arms have the same intervention techniques (relative intervention, stimulus control and others) except relapse prevention sessions. In the experimental arm, these sessions are carried out from Mindfulness, and in the active comparator is the usual relapse prevention.
15920103|NCT03497234|Diagnostic Test|Perilynx Analyzer to measure AF and VF fluid|Hologic developed a rapid in-vitro diagnostic system composed of an analyzer and cassettes to identify women with intra-amniotic infection.
15920104|NCT03497221|Behavioral|Education intervention|The same description of arm Education intervention.
15920107|NCT03497208|Procedure|Cell suspension|The technique involves preparation of a cell suspension (keratinocyte/melanocyte) prepared by trypsinization from a non-lesioned part of a patient's scalp skin and transepidermal delivery using a dermarollerequipped with 0.25 mm needles.
15920108|NCT03497208|Radiation|Phototherapy|The patient will receive phototherapy UVB-NB in the lesions of vitiligo after 15 days of the surgical procedure.
15920109|NCT03497195|Diagnostic Test|Screening at community level|comparison of chest x-ray and Xpert Ultra versus CRP and Xpert Ultra for active community based screening
15920110|NCT03497182|Device|Breath sample collection|Subject exhales into breath collection container.
15920111|NCT03497169|Drug|Lisdexamfetamine Dimesylate|Patients are tested for their normal prescription lisdexamphetamine medication
15920112|NCT03497156|Drug|Lercanidipine|Patients are tested for their normal prescription lercanidipine medication
15920113|NCT03497143|Drug|Lamotrigine|Patients are tested for their normal prescription lamotrigine medication
15920114|NCT03497130|Other|skin care regimen|These participants will be asked to apply skin care regimen, the Vaseline® Moisturizer twice a day and use Dove® Soap daily for 2 weeks.
15920115|NCT03497117|Device|Lung Clearance Index|To assess the efficiency of ventilation distribution and gas mixing by measuring the rate of clearance of an inert gas (nitrogen) from the lungs.
15920116|NCT03497117|Drug|MRI with PFP|"Description: inhaled PFP, a gaseous contrast agent (79% PFP, 21% O2, pre-mixed, medical grade gas)
~Administration: Full-face disposable ventilation mask and a standard Douglas Bag system.
~Dosage: Two controlled breaths of contrast gas followed by a full breath and a 12-second breath-hold and scan for image acquisition.
~Frequency: Repeated 5 times followed by an identical five cycles with room air to ensure PFP gas wash-out has occurred."
15920117|NCT03497104|Other|Surplus blood tests|Surplus blood donation
15920118|NCT03497091|Other|Enteral Formula|Enteral Feeding with an amino acid-based formula
15920119|NCT03497078|Other|Bone scintigraphy|Comparison of image quality between new collimator LEHRS (General Electric - GE Healthcare) vs Siemens LEHR on bone scintigraphy.
15920120|NCT03497065|Procedure|non-surgical periodontal treatment|scaling, root planing, polishing, and oral hygiene education was performed
15920121|NCT03497052|Other|In vitro culture in medium 1|Oocytes and embryos will be cultured in GEMS media (single step media) up to blastocyst stage.Standard IVF culture will be performed in a time lapse incubator. No drugs will be used.
15920122|NCT03497052|Other|In vitro culture in medium 2|Oocytes will be cultured in IRVINE media (single step media) up to blastocyst stage.Standard IVF culture will be performed in a time lapse incubator. No drugs will be used.
15920123|NCT03497039|Drug|Diclofenac Diethylamine (DDEA) gel|Diclofenac Diethylamine (DDEA) gel consists of 2.32% DDEA. DDEA gel will be applied twice a day for 7 days topically first and last dose by trained nurse (or designee) at study site and doses in between by a trained nurse at participant's home or other convenient location. Participants will be admitted on the day before the scheduled surgery (Day 7). The last dose of study treatment will be administered at the study site 12 hours (window -1/+3 hrs) prior to arthroplasty surgery.If surgery is delayed by up to 7 days dosing with DDEA gel twice daily can continue up to 14 days. If the surgery is delayed by more than 7 days, the participant should be withdrawn from the study.
15920124|NCT03497039|Other|Placebo gel|Placebo gel will be applied twice a day for 7 days topically first and last dose by trained nurse (or designee) at study site and doses in between by a trained nurse at participant's home or other convenient location. Participants will be admitted on the day before the scheduled surgery (Day 7). The last dose of placebo gel will be administered at the study site 12 hours (window -1/+3 hrs) prior to arthroplasty surgery. If surgery is delayed by up to 7 days dosing with placebo gel twice daily can continue up to 14 days. If the surgery is delayed by more than 7 days, the participant should be withdrawn from the study.
15920125|NCT03497026|Device|Robotic Bronchoscopy Platform|Eligible patients will undergo the robotic bronchoscopy for evaluation of suspected lung nodules.
15920126|NCT03497013|Device|Active tDCS|All patients received 2-mA anodal left/cathodal right prefrontal tDCS treatment (fifteen 30-minutes sessions: Monday to Friday once daily, every other week to do a group of treatment).
15920127|NCT03497013|Device|Sham tDCS|For sham stimulation, the device was set to turn off after 30 seconds(study model).
15920128|NCT03497000|Procedure|OCTA-guided Photodynamic therapy|Half-dose photodynamic therapy using verteporfin under the guidance of OCTA
15920129|NCT03497000|Procedure|ICGA-guided Photodynamic therapy|Half-dose photodynamic therapy using verteporfin under the guidance of ICGA
15920130|NCT03496987|Device|Vacuum Bottle Drainage|Patients undergo drainage via vacuum bottles
15920131|NCT03496974|Drug|Bermekimab Monoclonal Antibody 200 mg|200 mg subcutaneous injection
15920132|NCT03496974|Drug|Bermekimab Monoclonal Antibody 400 mg|400 mg subcutaneous injection
15920133|NCT03496961|Behavioral|Yan Nian Jiu Zhuan Fa|Yan Nian Jiu Zhuan Fa are the kneading methods while cognitive behavior education is the psychological education
15920134|NCT03496948|Behavioral|TeGeCoach|"12-month long telephone health coaching carried out by specially trained coaches. The health coaching is a patient-centered approach based on motivational interviewing, shared decision-making and active listening techniques. Primary care physicians will be constantly involved receiving regular health reports from the coach.
~The walking exercise is based on the principle of interval training. Patients will continuously wear an activity monitor device to review their exercise performance and for remote exercise monitoring by the coach. This activity information will be regularly reviewed by the coach to ensure that the patient adheres to the individual walking exercise prescription."
15920135|NCT03496935|Device|Tunneled versus non-tunneled dialysis catheter insertion|The study participants will be randomized either to tunneled or non-tunneled dialysis catheter insertion to commence renal replacement therapy for an acute kidney injury requiring either continuous or intermittent dialysis in the ICU.
15920136|NCT03496922|Behavioral|Experimental Tobacco Marketplace|See arm group description.
15920137|NCT03496909|Behavioral|Standard OT|12 weekly sessions of occupational therapy tailored to patients with RFS secondary to breast cancer treatment. Sessions can include manual therapy, education, and active and passive range-of-motion, etc.
15920138|NCT03496909|Behavioral|PhysioTouch|12 weekly sessions of occupational therapy tailored to patients with RFS secondary to breast cancer treatment. Sessions can include use of the PhysioTouch electronic massager in lieu of manual therapy, education, and active and passive range-of-motion, etc.
15920139|NCT03496896|Other|TARGET|The pre-discharge component includes mainly patient information, medication reconciliation, patient education, planning of a first post-discharge primary care physician visit with a timely discharge summary sent to the primary care physician. Two follow-up phone calls are made by a nurse, at D3 and D14, and include the assessment of the general health condition, the verification of the follow-up care plan, a reinforcement of the patient education, and review with the patient of the medication list with assessment of potential adverse drug events.
15920140|NCT03496883|Biological|Recombinant Activated Factor VII (rFVIIa)|Participants will be randomized in a double-blinded fashion to rFVIIa 80 µg/kg dose (maximum 10 mg dose) or matching placebo. Participants in both arms will receive best standard therapy as per published AHA Guidelines for ICH, including a target systolic blood pressure of 140 mm Hg.
15920141|NCT03496883|Biological|Placebo|Participants will be randomized in a double-blinded fashion to rFVIIa 80 µg/kg dose (maximum 10 mg dose) or matching placebo. Participants in both arms will receive best standard therapy as per published AHA Guidelines for ICH, including a target systolic blood pressure of 140 mm Hg.
15920142|NCT03496870|Drug|Opicapone|catechol-O-methyltransferase (COMT) inhibitor
15920143|NCT03496870|Drug|Carbidopa Levodopa|Levodopa: dopamine precursor Carbidopa: DOPA decarboxylase inhibitor
15920144|NCT03496857|Device|Light emitting diode|Three 10-min LED applications will be performed when the patient has a cervical dilatation of 4-5, 6-7, and 8-9 cm. Data on the level of pain, characteristics of the membrane (intact or damaged), heart rate, cardiotocography, and uterine dynamics will be collected after each intervention.
15920145|NCT03496857|Other|Bath Therapy|The method of analgesia with the bath therapy will be performed using a hot shower at 37°C for 10 min. After showering the entire body or the back for 5 min, the participants will be allowed to direct the water flow to any area of the body that feels the most comfortable and to adjust the temperature themselves for improved comfort. Bath therapy will be performed at three time points during labor: at cervical dilatation of 4-5 cm, 6-7 cm, and 8-9 cm. Data on the level of pain, membrane characteristics (intact or damaged), heart rate, cardiotocography, and uterine dynamics will be collected after the bath therapy by performing the same measurements used in the intervention group.
15920146|NCT03496844|Diagnostic Test|F-18 fluciclovine-PET/CT scan|PET/CT imaging with F-18 fluciclovine
15920147|NCT03496831|Drug|Biologic Agents|
15920148|NCT03496805|Drug|MGE|The patients will take 4 capsules by mouth BID (twice daily).
15920149|NCT03496805|Other|Placebo|The patients will take 4 capsules by mouth BID (twice daily).
15920150|NCT03496805|Other|ADT|Androgen deprivation therapy (ADT) is to be started within 60 days prior to initiation of MGE.
15920151|NCT03496792|Other|Tilt + external pressure|In Visit 1, the anti-shock trousers will be inflated to 20, 40, or 60 mmHg. BP will be measured 3 times from the brachial artery. Then the table will be tilted head up to a maximum of 70o for up to 10 min, while BP will be measured from the brachial artery at 1 min intervals. The tilt table is returned to 0o and the resting supine baseline BP will be collected. Then, the anti-shock trousers will be inflated to a different pressure (20, 40, or 60 mmHg) and the head up tilt will be repeated. Repetitions at the various pressures will be performed in a random order with suitable resting intervals in between the tilting bouts.
15920152|NCT03496792|Other|Tilt + no external pressure.|In Visit 1, the anti-shock trousers will NOT be inflated. Auscultatory BP will be measured 3 times from the brachial artery. Thereafter, the table will be tilted head up to a maximum of 70o for up to 10 min, while BP will be measured from the brachial artery at 1 min intervals.
15920153|NCT03496792|Other|Limb occlusion + negative pressure|In Visit 2, a cuff will be placed on the thigh of a leg that is sealed in an airtight pressure tank. After the cuff is inflated to 250 mmHg, the pressure in the tank will be reduced to -100mmHg for 2 minutes. The application of negative pressure creates a suction effect on the leg, and leads to an overall increase in pressure gradient across the blood vessel wall and induces vascular distension.
15920154|NCT03496792|Other|Limb occlusion + no negative pressure|In Visit 2, a cuff will be placed on the thigh of a leg that is sealed in an airtight pressure tank. The cuff is inflated to 250 mmHg for 2 minutes, but the pressure in the tank is not changed.
15920155|NCT03496779|Drug|Brentuximab Vedotin - induction|Brentuximab vedotin 1.8 mg/kg at D8 of a 28-day cycle - 4 cycles = 16 weeks for combined chemotherapy
15920156|NCT03496779|Drug|Gemcitabine|Gemcitabine 1000 mg/m² at D1 and D15 of a 28-day cycle - 4 cycles = 16 weeks for combined chemotherapy
15920157|NCT03496779|Drug|Brentuximab Vedotin - maintenance|"Patients who will obtain partial or complete response and who will not be eligible for transplant will receive maintenance therapy with brentuximab vedotin every 3 weeks for 12 infusions.
~Brentuximab vedotin 1.8 mg/kg at D1 of a 21-day cycle - 12 cycles = 36 weeks for maintenance therapy"
15920158|NCT03496779|Procedure|autologous or allogeneic stem cell transplantation|Patients who will obtain partial or complete response and who will be eligible for transplant will receive autologous or allogeneic stem cell transplantation
15920159|NCT03496766|Drug|Tipifarnib|Tipifarnib 600 mg will be administered until progression
15920160|NCT03496753|Device|Led Therapy|The following will be the phototherapeutic parameters: total spot area: 1.44 cm²; continuous emission mode; output power: 10 mW; infrared wavelength (880 to 904 nm); fluence: 4 J/cm²; and application time: 10 minutes/session. Sessions will be held three times a week on alternating days for six consecutive weeks, totaling 18 sessions.
15920161|NCT03496740|Procedure|Penile Block|Ultrasound guided dorsal penile nerve block will be done to this group of patients preoperatively, under general anesthesia. 0,25% Bupivacaine 0,5ml/kg (max. 20ml)
15920162|NCT03496740|Procedure|Pudendal Block|Nerve stimulation guided bilateral pudendal block will be done to this group of patients preoperatively, under general anesthesia. 0,25% Bupivacaine 0,5ml/kg (max. 20ml)
15920163|NCT03496740|Drug|Bupivacaine (Block Drug)|Block drug
15920164|NCT03496727|Procedure|Serratus anterior plane block|Serratus anterior plane block+patient controlled analgesia
15920165|NCT03496727|Procedure|Patient controlled analgesia|Patient-controlled analgesia
15920166|NCT03496714|Behavioral|Psychoeducation on trauma reactions|The psychoeducation handout and video on trauma symptoms will discuss reactions that are common after experiencing a trauma.
15920167|NCT03496714|Behavioral|Psychoeducation on safety behaviors|The psychoeducation handout and video on safety behaviors will discuss safety behaviors that are common in PTSD and tips for how to eliminate them.
15920168|NCT03496701|Device|Test lens|contact lens
15920171|NCT03496675|Behavioral|Group Music Therapy|The core intention of GMT is to meet the psychosocial needs of each person living with dementia, which in turn is thought to reduce depressive symptoms and anxiety and to stimulate overall social and emotional wellbeing. It includes active, reciprocal music making with the use of singing and musical instruments. GMT is provided by a trained music therapist, highly skilled as a musician, and registered with the appropriate professional association in his or her country.
15920172|NCT03496675|Behavioral|Recreational Choir Singing|RCS is intended to foster connectedness in a group, wellbeing, and enjoyment of music making in a group. It includes singing familiar songs and providing a familiar musical environment for participants. RCS is provided by a musician with choir leading skills.
15920173|NCT03496675|Other|Standard care|May include pharmacological and non-pharmacological interventions as locally available
15920174|NCT03496662|Drug|BMS-813160|BMS-813160 will be supplied by Bristol Myers Squibb
15920175|NCT03496662|Drug|Nivolumab|Nivolumab will be supplied by Bristol Myers Squibb
15920176|NCT03496662|Drug|Gemcitabine|Gemcitabine will be given as per routine care from commercial supply.
15920177|NCT03496662|Drug|Nab-paclitaxel|Nab-paclitaxel will be given as per routine care from commercial supply.
15920178|NCT03496662|Procedure|Biopsy|Pre-treatment, end of cycle 2, end of treatment for patients who progress or otherwise do not go to surgery, and surgery for patients who do go to surgery
15920179|NCT03496662|Procedure|Peripheral blood|-Cycle 1 Day 1 before treatment begins, after 2 cycles of treatment +/- 3 days of mandatory tumor biopsy, end of treatment for patients who progress or otherwise do not go to surgery, and no more than 24 hours prior to time of surgery (if applicable)
15920180|NCT03496649|Drug|Dysport 500 Unit Powder for Injection|Dysport administered by intramuscular injection
15920181|NCT03496636|Procedure|Ovarian tissue transplant|Pieces of previously frozen ovarian cortex will be put in the abdomen laparoscopically, or with mini laparotomy
15920182|NCT03496623|Drug|Inhaled treprostinil solution|Treprostinil inhalation solution
15920183|NCT03496623|Drug|Placebo solution|Placebo solution
15920184|NCT03496610|Drug|Liposomal Bupivicaine|Patient will receive liposomal bupivicaine mixed with non-liposomal bupivicaine directly to wound
15920185|NCT03496610|Procedure|QL Block|Patient will receive ultrasound guided QL Block
15920188|NCT03496584|Other|Pomegranate Juice|After the one week run-in period of consuming an ellagitannin-free diet, participants will undergo the skin testing followed by the postprandial meal test with a high fat (HF) test meal consumed with the first dose of the intervention (Pom J or placebo). For the next 12 weeks, participants will consume a daily dose of pomegranate juice 1x/day. During week 4 participants will undergo another skin testing. During week 12 participants will undergo another skin testing and postprandial meal challenge. Stool will be collected at week 1, 4 and 12.
15920189|NCT03496584|Other|Placebo Juice|After the one week run-in period of consuming an ellagitannin-free diet, participants will undergo the skin testing followed by the postprandial meal test with a high fat (HF) test meal consumed with the first dose of the intervention (Pom J or placebo). For the next 12 weeks, participants will consume a daily dose of placebo juice 1x/day. During week 4 participants will undergo another skin testing. During week 12 participants will undergo another skin testing and postprandial meal challenge. Stool will be collected at week 1, 4 and 12.
15920190|NCT03496571|Drug|AK002|AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8, a member of the CD33-related family of sialic acid-binding, immunoglobulin-like lectins (Siglecs).
15920191|NCT03496571|Other|Placebo|Placebo
15920192|NCT03496558|Other|Variability of the lipid profile in pregnant women|"The women participants will be divided into two groups. Group 1 comprised of healthy women and group 2 by pregnant women with a history of risk. A personal, family history and a detailed medical history will be taken in each group. We will proceed to see all possible variables that influence the level of biomarkers (lipids and prolactin).
~At least 60 healthy pregnant women and 60 pregnant women with a history of risk (20 for each risk) x 2 series (three years) will be tried, a total of 240-300 women to whom 5 analytical tests would have to be performed."
15920193|NCT03496545|Drug|Bromocriptine 5 MG|Bromocriptine 5 mg every 4 hours PO/NG/FT
15920194|NCT03496545|Drug|Acetaminophen 650 MG|Acetaminophen 650 mg every 4 hours PO/NG/FT for 48 hours
15920195|NCT03496532|Device|biphasic stimulation|Fixed 70Hz symmetrical biphasic pulses
15920196|NCT03496532|Device|standard stimulation|Fixed 70Hz pseudo-monophasic pulses
15920197|NCT03496532|Device|Uniform distribution|Uniform distribution 70Hz Biphasic pulses
15920198|NCT03496532|Device|Poisson distribution|Poisson distribution 70Hz Biphasic pulses
15920199|NCT03496532|Device|Recordings of LFP oscillations|"Two minutes of recordings of LFP oscillations will be performed from the contacts of the implanted electrode.
~Recordings of the depth of anaesthesia (BIS) all along the measurements performed under general anaesthesia.The correlation between the depth of anaesthesia and the cerebral oscillations recorded at the site of subthalamic nucleus will be studied."
15920200|NCT03496519|Drug|Dose Escalation of Durvalumab and Trabectedin|"There will be a fixed dosage of Durvalumab, 1125mg, given intravenously over 60 minutes on Day 2 every 21 days. There will be an increase in Trabectedin for each cohort, given through intravenous infusion over a 24 hour period on Day 1 every 21 days as an outpatient.
~Cohort -1: Durvalumab 1125mg with Trabectedin 0.5mg/m2
~Cohort 1: Durvalumab 1125mg with Trabectedin 0.75mg/m2
~Cohort 2: Durvalumab 1125mg with Trabectedin 1.0mg/m2
~Cohort 3: Durvalumab 1125mg with Trabectedin 1.2mg/m2
~Cohort 4: Durvalumab 1125mg with Trabectedin 1.5mg/m2"
15920201|NCT03496519|Drug|Dose Expansion of Durvalumab and Trabectedin|There will be a fixed dosage of Durvalumab, 1125mg, given intravenously over 60 minutes on Day 2 every 21 days. There will be a fixed dosage of Trabectedin for each cohort, whatever was determined to be the safest dose during the Dose Escalation Phase, and it will be given through intravenous infusion over a 24 hour period on Day 1 every 21 days as an outpatient.
15920202|NCT03496506|Drug|Selexipag|Each film-coated tablet contains 200 microgram (mcg) of selexipag (oral use)
15920203|NCT03496506|Drug|Clopidogrel|Each film-coated tablet containing 75 mg of clopidogrel (oral use)
15920204|NCT03496493|Device|All patients|Peripheral arterial oxygen saturation recording with both study devices
15920205|NCT03496480|Diagnostic Test|Questionnaires|Psychological questionnaires: BTQ, IES-R, 7-items-short Screening scale, BDI, SF-36
15920206|NCT03496467|Combination Product|Nepafenac PPDS|A punctal plug delivery system (PPDS) is being developed as a device that can deliver a sustained release of a drug to a specific eye. The PPDS is made up of a medical grade silicone punctal plug which holds an insert (core) that contains nepafenac, a nonsteroidal anti-inflammatory drug.
15920207|NCT03496467|Combination Product|Placebo PPDS|A punctal plug delivery system (PPDS) is being developed as a device that can deliver a sustained release of a drug to a specific eye. The PPDS is made up of a medical grade silicone punctal plug which holds an insert (core) that does not contain nepafenac.
15920208|NCT03496454|Other|PfSPZ Challenge|The administration of an injection PfSPZ Challenge in Gambian adults
15920209|NCT03496441|Other|Fecal sample collection for analysis|Fecal sample analysis will consist of the following procedure : Microbial DNA extraction, amplicon library construction, sequencing and analysis; Clustering MiSeq reads into operational taxonomic units (OTUs); Iron and heme measurements in the samples.
15920210|NCT03496428|Device|Dental implant impressions- Different Techniques|Assessment of soft tissues changes with different techniques
15920211|NCT03496415|Device|remote ischemic conditioning|Remote ischemic conditioning is performed by using an electric autocontrol device with cuffs that inflated to a pressure of 200 mm Hg during the ischemic period (Patent No. CN200820123637.X, China)
15920212|NCT03496415|Device|sham remote ischemic conditioning|sham remote ischemic conditioning is performed by using an electric autocontrol device with cuffs that inflated to a pressure of 60 mm Hg
15920213|NCT03496402|Other|Sampling on blood, bone marrow and cerebrospinal fluid|biological sampling during treatment and follow-up
15920214|NCT03496389|Drug|Gabapentin|Gabapentin 300mg daily
15920215|NCT03496389|Drug|Tramadol|Tramadol 50mg QID
15920216|NCT03496389|Drug|Panadol|Panadol 500mg QID
15920217|NCT03496376|Other|Kinesio Taping|The material used for thoracic kinesio taping application was Kinesio® Tex Gold™ (Kinesio Holding. Patients were instructed to sit upright on an armless chair with no back support, with knees flexed to 90 degrees, feet on the floor and arms relaxed. Kinesio tape was applied anteriorly and posteriorly to facilitate respiratory muscles (primarily diaphragm) along the subcostal area. Additionally, two more kinesio tapes were applied to upper trapezius and scalene muscles' area which lies between neck and acromion at both sides (left and right).
15920218|NCT03496376|Other|Deep Breathing Exercises|Three different deep breathing exercises (diaphragmatic, thoracic, and lateral basal), each consisting of three sets of 10 repetitions, with 30 seconds of rest between each set.
15920219|NCT03496363|Diagnostic Test|TSH , T4|Thyroid stimulating hormone
15920220|NCT03496350|Behavioral|Internet-delivered CBT|Culturally adapted transdiagnostic internet-delivered CBT in Arabic
15920221|NCT03496337|Other|Assessment of motor and process skills test|At baseline and follow-up (after 8-10 weeks) all patients are assessed with AMPS in addition to the standard test of Canadian Occupational Performance Measure (COPM) hand grip strength and joint range of motion.
15920222|NCT03496324|Drug|Nurofen for Children®|Nurofen for Children® 400 mg/10 ml
15920223|NCT03496324|Drug|Algifor® Junior|Algifor® Junior 400 mg/20 ml
15920224|NCT03496311|Diagnostic Test|Acid - Base characterization|Samples of cerebrospinal fluid and arterial blood will be collected anaerobically to measure acid-base variables, electrolytes, albumin, progesterone and copeptin levels
15920225|NCT03496298|Drug|Efpeglenatide (SAR439977)|"Pharmaceutical form: Solution for injection,
~Route of administration: SC"
15920226|NCT03496298|Drug|Placebo|"Pharmaceutical form: Solution for injection
~Route of administration: SC"
15920227|NCT03496285|Radiation|Multimodal MRI with diffusion sequence for anorexia nervosa patient|Multimodal MRI with diffusion sequence, resting state, T2, T1 without gadolinium contrast
15920228|NCT03496285|Radiation|Multimodal MRI with diffusion sequence for obsessional compulsive disorder patient|Multimodal MRI with diffusion sequence, resting state, T2, T1 without gadolinium contrast
15920229|NCT03496285|Radiation|Multimodal MRI with diffusion sequence for healthy volunteer|Multimodal MRI with diffusion sequence, resting state, T2, T1 without gadolinium contrast
15920230|NCT03496259|Device|On-Q pump|Type of pain control device used
15920231|NCT03496259|Device|Epidural catheter|Type of pain control device used
15920232|NCT03496246|Diagnostic Test|serum total 25 hydroxycholecalciferol 25(OH) vitamin D|Quantitative measurement of serum total 25(OH) vitamin D by ELISA. Fasting (6-8 hours), venous blood samples(10ml) are collected from participants in the morning and after centrifugation, the serum are preserved in the deep freezer at -20 c. Serum levels will be determined by using commercially available kits.
15920233|NCT03496246|Diagnostic Test|complete blood count (CBC)|for measurement of hemoglobin level and white blood cell count percent of neutrophils ,lymphocytes and esoinphils
15920234|NCT03496246|Diagnostic Test|serum calcium level|measurement of total calcium level after correction with albumin level as it is closely related to vitamin d with its effects on its level
15920235|NCT03496246|Diagnostic Test|erythrocyte sedimentation rate (ESR)|it is an indicator of activity in inflammatory bowel disease
15920236|NCT03496246|Diagnostic Test|C-reactive protein (CRP)|it is an indicator for increased possibility of infections
15920237|NCT03496246|Diagnostic Test|serum creatinine|for assessment of renal function
15920238|NCT03496246|Diagnostic Test|serum albumin level|for possibility of malabsorbtion in patients with inflammatory bowel disease
15920239|NCT03496246|Diagnostic Test|seum alanine aminotransferase|for assessment of liver function
15920240|NCT03496246|Diagnostic Test|serum potassium level|indicator for hypokalemia increased in patients with diarrhea as result of inflammatory bowel disease
15920241|NCT03496246|Diagnostic Test|serum phosphurus level|measurement of phosphurus level as it is closely related to vitamin d with its effects on its level
15920242|NCT03496233|Drug|Elbasvir 50 MG / Grazoprevir 100 MG Oral Tablet [Zepatier]|Treatment with EBR/GZR Fixed-Dose Combination for 8 Weeks in G1b Treatment-Naïve, HCV-Infected Patients, with non- severe fibrosis, with or without IR and/or DM
15920243|NCT03496220|Device|Angulus|Feedback on patient recumbency
15920245|NCT03496207|Drug|Sotatercept|Sotatercept (ACE-011) is a recombinant fusion protein consisting of the extracellular domain of the human activin receptor type IIA linked to the Fc piece of human IgG1
15920246|NCT03496181|Behavioral|Multilingual Aphasia Examination|"For patients only prior to MRI scans.
~The MAE contains eleven subtests in five categories which may be used to assess both languages in bilinguals and the participant's primary language in monolinguals: Oral Expression, Spelling, Oral Verbal Understanding, Reading, and Rating Scales. Subtests are scored for accuracy of individual items on a three-point scoring system (0, 1, 2). Contained within these domains are The Token Test, Aural Comprehension of Words and Phrases and Visual Naming which naturally parallel fMRI and direct cortical stimulation behavioral assays already in place for clinical use (phonemic fluency, auditory responsive naming and confrontation naming respectively). The MAE is expected to take under 50 minutes."
15920247|NCT03496181|Diagnostic Test|Language paradigms + RS fMRI|10 monolingual patients: 2 language paradigms + RS fMRI = 7x3 = 21 minutes 10 early bilingual patients: 2 language paradigms+ RS fMRI = 7x3 = 21 minutes 10 late bilingual patients: 2 language paradigms+ RS fMRI = 7x3 = 21 minutes
15920248|NCT03496181|Diagnostic Test|Language paradigms + RS fMRI + one anatomical sequence|"10 monolingual English volunteers: 2 task language paradigms* + 1 Resting State fMRI + one anatomical sequence for a total of approximately 25 minutes.
~10 late bilingual volunteers: 4 language paradigms (2 English + 2 Spanish) + 1 Resting State fMRI + one anatomical sequence for a total of approximately 39 minutes.
~10 early bilingual volunteers: 4 language paradigms (2 English + 2 Spanish) + 1 Resting State fMRI + one anatomical sequence for a total of approximately 39 minutes."
15920249|NCT03496168|Drug|mavacamten|mavacamten capsules
15920250|NCT03496155|Behavioral|Build and Support Your Teen's Strengths|"This is a clinic based psychoeducational intervention for adolescent patients and their parents to improve parent-teen communication about teen strengths. The intervention is designed, if possible, to coincide with the adolescent patients' well-child visits and consists of the following components: (1) In-person or over the phone orientation session with a trained health coach and parent, (2) Distribution of psychoeducational materials to the parent, (3) Endorsement and delivery of key messages from the health care provider, and (4) Booster phone call placed by the health coach."
15920251|NCT03496142|Procedure|Transperineal prostate biopsy|Puncture of 12 to 30 percutaneous prostate core biopsies through the perineum with a transrectal ultrasound probe guidance. The procedure would be performed with the Artemis (Eigen) device allowing topographic recording of the puncture and MRI / ultrasound image fusion in order to target the MRI suspected lesion.
15920252|NCT03496142|Procedure|Transrectal prostate biopsy|Patient would undergo 12 to 30 transrectal prostate core biopsies through the rectum with a transrectal ultrasound probe guidance. The procedure would be performed with the Artemis (Eigen) device allowing topographic recording of the puncture and MRI / ultrasound image fusion in order to target the MRI suspected lesion.
15920253|NCT03496129|Behavioral|Personalized feedback|Following the baseline assessment, participants will be sent a link via text message to a secure website containing substance-impaired driving specific personalized feedback. Feedback will include the following elements: a personalized substance use profile and substance-impaired driving profile, information on social norms related to substance use and substance-impaired driving, personalized information on BAC (or level of impairment due to drug use) prior to driving, costs associated with a DUI citation in Kentucky, and information on combined drug and alcohol impaired driving risk (if endorsed).
15920254|NCT03496129|Behavioral|Personalized feedback and text messages|"Experimental: Personalized feedback and text messages
~Following the baseline assessment, participants will be sent a link via text message to a secure website containing substance-impaired driving specific personalized feedback (described above). Participants will be asked to send a text message back to the study administrator after viewing the feedback document. After confirming receipt and processing of the document, the study administrator will then send the participant three text messages containing open-ended questions."
15920255|NCT03496129|Behavioral|Information Only|"Active Comparator: Information Only
~Students randomized to the information condition will receive standard information about alcohol and other drugs and substance-impaired driving via a link to a website delivered through text message."
15920256|NCT03496116|Other|ECIG Session|Participants will complete four sessions using an e-cigarette, including a 10-puff product use bout followed by a 60-minute ad lib bout over an approximately 4-hour period. The study conditions for each session (i.e., heater resistance and nicotine combinations) will be Latin-square ordered.
15920257|NCT03496103|Biological|ragweed pollen|three hours ragweed pollen in a allergen exposure chamber
15920258|NCT03496090|Other|Free diet|Free diet or free demand, being comparable to the normal or zero hospital diet
15920259|NCT03496090|Other|Progressive diet|Progressive diet for 7 days, liquid diet for the first three days and soft diet without waste, from the 4th to the 7th day.
15920260|NCT03496077|Other|Flavored and unflavored little cigars/cigarillos (LCCs)|Flavored and unflavored LCCs that are currently available for purchase
15920261|NCT03496064|Other|Successful reperfusion|Defined as modified Thrombolysis in Cerebral Infarction 2b/3
15920262|NCT03496038|Procedure|L-PRF|The use of the L-PRF as graft material for sinus augmentation procedure will be analysed
15920263|NCT03496038|Procedure|DBBM|The use of bovine xenograft as graft material for sinus augmentation procedure will be analysed
15920264|NCT03496025|Device|Electrical muscle stimulation|The intervention consists of activating paralyzed facial muscles with electrical stimulation.
15920265|NCT03496012|Genetic|BIIB111|Administered as specified in the treatment arm.
15920266|NCT03495999|Diagnostic Test|hyperuricemia|serum uric acid of 7mg/dl or more in men or 6mg/dl or more in women
15920267|NCT03495986|Device|Functional Electrical Stimulation Leg Cycle Ergometry|Exercise training will consist of three to five, 40-67 minute sessions (200 minutes at target intensity) each week for a total of 16 weeks at 70% maximal heart rate; 10-minute warm-up and cool-down sessions will accompany each exercise session.
15920268|NCT03495986|Behavioral|Diet|An individualized, detailed dietary plan consistent with My Healthy Plate Dietary Guidelines of America will be followed under supervision of Registered Dietitian with weekly telemedicine conferences and monitored dietary intake via MyFitnessPal.
15920299|NCT03495713|Drug|Nivolumab|Nivolumab 3 mg/kg will be administered on day 1 (pre-response assessment week 0) and on day 1 and continued per standard of care and institutional practices. A
15948774|NCT03273842|Biological|US-approved Neulasta|pre-filled syringe 6 mg
15920269|NCT03495973|Drug|Ustekinumab|Participants that are initiated on treatment with ustekinumab and are registered in Swibreg will be recruited into the cohort. All aspects of treatment and clinical management of participants will be in accordance with local clinical practice and applicable local regulations, and at the discretion of the participating physician.
15920270|NCT03495960|Drug|Rituximab|"PART A - INDUCTION PHASE During the primary chemo-immunotherapy (PRIMAIN regimen, 2 courses; every 43 days) administered as induction in the PART A of the study, Rituximab is given 375 mg/m2 as standard infusion at days -6, 1, 15 & 29. Rituximab on day -6 will be delivered only during the first course; it will be delivered between day -6 and day 0 according to clinical requirements and patient's conditions. Some patients would need for a fast chemotherapy starting.
~PART B - INDUCTION PHASE Patients ineligible for high-dose methotrexate, will be assigned to receive concomitant whole brain radiotherapy-temozolomide-rituximab (Induction Part B). Rituximab is given 375 mg/m2 in 4 weekly doses, starting on day 2 of radiotherapy."
15920271|NCT03495960|Drug|Methotrexate|During the primary chemo-immunotherapy (PRIMAIN regimen, 2 courses; every 43 days) administered as induction in the PART A of the study, Methotrexate is given 3 g/m2 as infusion (0.5 g/m2 in 15 min. + 2.5 g/m2 in 3-hr infusion) on days 2, 16 & 30
15920272|NCT03495960|Drug|Procarbazine|"PART A - INDUCTION PHASE During the primary chemo-immunotherapy (PRIMAIN regimen, 2 courses; every 43 days) administered as induction in the PART A of the study, Procarbazine is given oral 60 mg/m2/d from days 2 to 11
~PART A - MANTEINANCE PHASE (control arm) Patients responsive or with stable disease after two courses of PRIMAIN regimen (the induction treatment) will be randomly allocated to receive two different maintenance therapies. Maintenance will start on day 60 of the 2nd PRIMAIN course.
~Procarbazine represents the control arm and is given oral 100 mg/d from day 1 to 5 for 6 courses, every 4 weeks."
15920273|NCT03495960|Drug|Lenalidomide|"Patients responsive or with stable disease after two courses of PRIMAIN regimen (the induction treatment) will be randomly allocated to receive two different maintenance therapies. Maintenance will start on day 60 of the 2nd PRIMAIN course.
~Lenalidomide represents the experimental arm and is given oral 25 mg/d from day 1 to 21 for 24 courses; every 4 weeks."
15920274|NCT03495960|Radiation|Radiotherapy|Patients ineligible for high-dose methotrexate, will be assigned to receive concomitant whole brain radiotherapy-temozolomide-rituximab (Induction Part B). Whole-brain will be irradiated by two opposite lateral fields including the first two cervical vertebras and the posterior two thirds of the eyes. Photons of 4 - 10 MeV, 180 - 200 cGy per day, 5 weekly fractions will be employed
15920275|NCT03495960|Drug|Temozolomide|"PART B - INDUCTION PHASE Patients ineligible for high-dose methotrexate, will be assigned to receive concomitant whole brain radiotherapy-temozolomide-rituximab (Induction Part B). Temoyolomide is given 75 mg/m2/d, every day for the whole duration of radiotherapy.
~PART B - MAINTENANCE PHASE Temozolomide is also given as maintenance in Part B. The treatment consists of 12 courses where temozolomide is administered on days 1-5, every 4 weeks at a dose of 150 mg/m2/d at the first course, and of 200 mg/m2/d at the subsequent courses,"
15920276|NCT03495947|Behavioral|high flow nasal cannula|24 hours of continuous use in the immediate post-extubation period.
15920277|NCT03495934|Drug|pracinostat|[14C]-pracinostat
15920281|NCT03495908|Device|VGo|Eligible subjects will be randomized to either stay on RAI delivered by V-Go or randomized to switch to U-100 RHI delivered by V-Go.
15920282|NCT03495895|Behavioral|Minding the Baby|Visits are carried out on an alternating basis by a team made up of a nurse practitioner (NP) and social worker.
15920283|NCT03495895|Behavioral|Usual Care|Usual care condition
15920284|NCT03495882|Drug|AGEN1884 + AGEN2034|AGEN1884 + AGEN2034 according to protocol design
15920285|NCT03495856|Behavioral|Mindfulness Training For Chronic Pain|4-week group Mindfulness training program for adults with chronic pain
15920286|NCT03495843|Diagnostic Test|Spinal stiffness|Spinal stiffness will be assessed with a device, which measures tissue compliance according to the concept of impulse-response
15920287|NCT03495830|Procedure|Carotid endarterectomy|Exploration of carotid bifurcation. Clamping of carotid artery and plaque removal with endarterectomy. Plaque is stored. Suture of artery with direct suture or patch.
15920288|NCT03495817|Drug|ATI-50002|ATI-50002 Topical Solution
15920289|NCT03495804|Drug|polyethylene glycol|Experimental group was given polyethylene glycol as oral contrast agent.
15920290|NCT03495804|Drug|mannitol|Active comparator group was given mannitol as oral contrast agent.
15920291|NCT03495791|Other|YouTube Video|Educational Video
15920292|NCT03495778|Other|Test Granola|50.5 Test Granola
15920293|NCT03495778|Other|Control Granola|54.3 Control Granola
15920294|NCT03495765|Drug|Ranibizumab|Ranibizumab 0.5mcg via intravitreal injection to study eye up to monthly
15920295|NCT03495752|Other|Bruce Fatigue Protocol|Participant will perform the Bruce protocol as a fatigue stimulus to examine the impact of fatigue on the FSDT
15920296|NCT03495739|Drug|RDG-17012 Capsule|Dabigatran Etexilate tosylate 150mg
15920297|NCT03495739|Drug|Dabigatran Etexilate Mesylate 150 MG Oral Capsule|Dabigatran Etexilate mesylate 150mg
15920298|NCT03495726|Behavioral|Headspace app|Headspace is a Contemplative Application (App) for Well-being (CAW). Participants will be provided initial instructions for downloading and using the Headspace app. The Headspace app includes guided meditations, articles and videos. Participants will be asked to engage in meditation practice for an average of 10 minutes a day during the 6-week training period.
15920399|NCT03494868|Dietary Supplement|Carbohydrate Drink|2 - 12 oz drinks
15920300|NCT03495700|Procedure|L-PRF block|The use of the L-PRF block as graft material for sinus augmentation procedure will be analysed
15920301|NCT03495700|Procedure|DBBM|The use of bovine xenograft will be analysed
15920302|NCT03495674|Behavioral|Exercise Intervention|Complete cycling classes
15920303|NCT03495674|Other|Informational Intervention|Receive information about exercise guidelines
15920304|NCT03495674|Device|Monitoring Device|Wear Fitbit
15920305|NCT03495674|Other|Questionnaire Administration|Complete questionnaire
15920306|NCT03495661|Procedure|Decompression|Central decompression of the stenotic segment(s) with undercutting of the lateral recesses.
15920307|NCT03495648|Behavioral|walking group led by a community organizer|Subjects will walk 1 kilometer from a pre-determined point to a local farmer's market.
15920308|NCT03495648|Behavioral|Drive|Subjects will drive to a local farmer's market.
15920309|NCT03495635|Behavioral|Big Brothers Big Sisters Community-Based Mentoring Program|One-to-one mentoring provided by an adult volunteer with training and ongoing monitoring and support from program staff.
15920310|NCT03495622|Behavioral|Motivational Interviewing/Text messaging|"The intervention is a multi-component one that is tailored to the individual and will target smoking cessation. The CHW, after identifying the individual's stage of behavior change, will provide motivational interviewing and set up an automatic text messaging system with their mobile phones that are structured around a quit date chosen by the participant.
~The CHW visits are pre-determined and she monitors the progress of the individual regularly. She may restart the process of determining the stage of behavior change for those who relapse or quit the intervention midway thereby reassigning them to the appropriate phase of the trial"
15920311|NCT03495609|Drug|Ovitrelle|Ovitrelle will be injected in 35 asymptomatic women with BRCA1 or BRCA2 mutation during 90 days (an extra 4 weeks in a subgroup). The gene expression of the breast epithelial cells will be characterized and compared to the gene expression of the breast epithelial cells before ovitrelle injection.
15920312|NCT03495596|Device|Videolaryngoscopy|Videolaryngoscopy device type
15920313|NCT03495583|Other|Early introduction|Consumption of 2g/week of cow's milk, hen's egg, wheat, peanut, sesame and fish protein from 3 months of age (alongside breastfeeding)
15920314|NCT03495570|Diagnostic Test|blood draw|single one time blood draw to measure lymphocyte panels included activated lymphocytes using remnant sample from a full blood count
15920315|NCT03495557|Procedure|Control|Fascial closure with simple polydioxanone suture 2/0 stitches
15920316|NCT03495557|Device|Experimental|Onlay polypropylene mesh placement (MN mesh)
15920317|NCT03495544|Diagnostic Test|PD-L1 expression|IHC testing of PD-L1 expression level in tumor tissue samples
15920318|NCT03495531|Device|Virtual Reality|Virtual Reality headset with calming scenery
15920319|NCT03495518|Other|Symptom feedback to Health Care Provider|"These children will complete SPARK daily for 5 days in a row, daily symptom reports will be printed and provided in the patient chart. On days 1 and 3, a report describing symptoms that are a lot or extremely bothersome will be emailed to the physician providing direct medical"
15920320|NCT03495518|Other|Standard of care|A clinical research associate will visit the participant on days 1 and 5±1 and will obtain SSPedi scores on an iPad. Reports will not be printed or emailed to the physician.
15920321|NCT03495505|Device|WiSE-CRT|Intervention will involve placement of the WISE-CRT system which consists of a transmitter, battery and electrode.
15920322|NCT03495492|Device|Dermal Chelation|Dermal chelation with Aqua DetoxTM system for one or more hours one or more times each week.
15920323|NCT03495492|Dietary Supplement|Nutritional Therapy|Vitamins and minerals that will be taken one or more times a day.
15920325|NCT03495466|Procedure|Local only anesthesia vs Local with sedation anesthesia|The investigators are comparing two approved sedation types that are using during carpal tunnel surgery.
15920326|NCT03495453|Device|Percutaneous Revascularization of the Femoropopliteal Arteries using a DAS|"Diamondback 360 Peripheral Orbital Atherectomy System (OAS) is a small catheter with a diamond crown. The doctor inserts it at the groin and advances into the leg.The OAS works by spinning around inside the artery to sand down the buildup of material along the artery walls while leaving the healthy vessel behind."
15920327|NCT03495453|Device|Percutaneous Revascularization of the Femoropopliteal Arteries using a OAS device|HawkOne Directional Atherectomy System (DAS) also is the small catheter with cutting device. Doctor slowly and smoothly advances it across the blockage in your artery and shaves the plaque from the vessel wall and collects it in the reservoir.
15920328|NCT03495440|Behavioral|Center Sessions|Program to support relationships and communication between parents and typically developing adolescent siblings of individuals with intellectual and/or developmental disabilities.
15920329|NCT03495440|Behavioral|At-home|Self-study resources paired with regular contact with study personnel.
15920330|NCT03495427|Drug|F-DCFPyL Injection|F-DCFPyL Injection is a radioactive diagnostic imaging agent indicated for imaging of patients with recurrent prostate cancer.
15920331|NCT03495427|Diagnostic Test|PSMA PET|PSMA PET imaging (for men with high GC >0.45) will be done after 2 years post-treatment, then yearly up to 5 years.
15920332|NCT03495414|Other|Brain Imaging|"Structural MRI (T1 weighted)
~Diffusion Tensor Imaging (DTI)
~resting state functional MRI (rs-fMRI)
~functional MRI (fMRI): Brain activity will be measured in response to sexual images (visually evoked sexual arousal; processing of sexual stimuli), and importantly during a phase when these stimuli are anticipated (neural correlates of wanting and desire; reward anticipation)."
15920333|NCT03495414|Other|Cognitive testing|"We will administer neuropsychological tests assessing objective measures for
~intelligence (Ravens Matrices)
~impulsivity and risk-taking behavior (Balloon Analogue Risk Task)
~inhibitory control (Stop Signal Task)."
15920334|NCT03495414|Other|Psychometric|Administered questionnaires include anxiety and depression symptoms (MADRS, HADS, GAD), drug use (AUDIT, DUDIT), attention deficits (ASRS), impulsivity (BIS-11), reward seeking behavior (BIS/BAS), sexual orientation, (hyper)sexual behavior, desire and compulsivity aspects (HDSI, HBI, SCS, SDI, SIS/SES).
15920335|NCT03495414|Other|Blood test|Blood samples will be taken for routine health assessment, measurement of sex hormonal levels, HPA-axis function test (dexamethasone suppression), and potential DNA extraction and (epi)genetic profiling.
15920336|NCT03495401|Dietary Supplement|fortified synbiotic milk|100 ml fortified (7,47 mg ferrous sulphate and 4,33 mg zinc acetate) synbiotic milk containing 7 billion CFU Lactobacillus plantarum Dad13 in combination with 4 g prebiotic fructooligosaccharides
15920337|NCT03495401|Dietary Supplement|non-fortified synbiotic milk|100 ml non-fortified synbiotic milk containing 7 billion CFU Lactobacillus plantarum Dad13 in combination with 4 g prebiotic fructooligosaccharides
15920338|NCT03495375|Dietary Supplement|Treatment with a probiotic|All participants will take the probiotic once daily for 10 weeks in the form of a powder that can be spread on top of cold foods such as muesli, salad, or yogurt.
15920339|NCT03495375|Other|Treatment with placebo|All participants will take the placebo once daily for 10 weeks.
15920340|NCT03495362|Dietary Supplement|Yeast Beta-glucan|Twice a day, 1 capsule each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.
15920341|NCT03495362|Other|Placebo|Twice a day, 1 capsule each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.
15920342|NCT03495349|Other|safety and effectiveness of the usual treatments of diabetic foot infections|clinical and biological follow-up necessary to assess the safety and effectiveness of the medical treatments, MOS-SF survey (36-Item Short Form Survey) to study the quality of life.
15920343|NCT03495336|Other|coffee abstention phase|no coffee consumption for 2 weeks
15920344|NCT03495336|Other|LR Coffee consumption|for 4 weeks participants consumed only LR Turkish coffee
15920345|NCT03495336|Other|DR Coffee consumption|for 4 weeks participants consumed only DR Turkish coffee
15920346|NCT03495323|Drug|LY3300054|LY3300054 is a monoclonal antibody that targets programmed cell death ligand 1 (
15920347|NCT03495323|Drug|Prexasertib|Prexasertib work by preventing the cancer cells from being able to repair damaged DNA (one of the building blocks of a cell) which then leads to cell death
15920348|NCT03495310|Behavioral|Mindfulness|Mindfulness is a method based on the concentration of attention, awareness and meditation, which has been used successfully to reduce stress, depression and anxiety in individuals with some pathology in the short term
15920349|NCT03495297|Procedure|ommitence of defibrillation testing|Induction of a ventricular arrhythmia to test proper arrhythmia detection and termination by the implanted device is omitted
15920350|NCT03495284|Dietary Supplement|Potato-based side dish|Daily consumption of a potato-based side dish equivalent to one medium size potato for 4 weeks
15920351|NCT03495284|Dietary Supplement|Refined grain-based|Daily consumption of an isocaloric refined grain-based side dish for 4 weeks
15920352|NCT03495258|Procedure|Clarion Evolve Laser Vaporization System|
15920353|NCT03495258|Procedure|Olympus TURis Plasma Vaporization|
15920354|NCT03495232|Device|Zimmer Biomet Persona total knee system|Product manufactured by Zimmer Biomet used to replace the knee joint.
15920355|NCT03495219|Procedure|Esophageal Manometry|A catheter inserted through the nares, post appropriate anesthetization. The subject is then given 8 - 10 sips of water or semi viscous fluid during the routine study. At the conclusion of the clinical portion of the examination the manometer catheter is typically removed by the technician at that point. For the purposes of this research study the catheter will remain in place to examine pressures specifically at the lower end of the esophagus during various breathing patterns and training activities to see if pressures can be increased with instruction.
15920356|NCT03495206|Drug|Y-2(Edaravone And Borneol) Sublingual Tablet|Y-2 sublingual tablet at single ascending doses of one tablet , two tablets, three tablets, four tablets
15920357|NCT03495193|Other|Exercise training|Exercise training will be performed 3x/week. After 2 sessions, training volume and intensity will progress over the first 4 sessions ramping up the number of sets to increase the volume. The full volume prescription will consist of: 1) 5 movements to improve strength and muscle mass (leg press, knee extension, chest press, overhead press, pull down), 3 sets each of 8-12 repetitions (~30 total repetitions); 2) trunk exercises to improve postural stability (trunk extension and flexion); 3) 3-4 bodyweight exercises (selected from a menu) to improve power and balance (e.g. step up, squat, jump squat, lunge, side lunge, push-up, assisted pull-up, assisted dip). Bodyweight movements will be modified as necessary to match abilities.
15920358|NCT03495193|Behavioral|Sleep hygiene|Subjects randomized to the no-exercise group will receive a handout with tips for improving sleep. Additionally, study staff will provide the title page for a book on sleep relaxation techniques that is recommended for persons with sleeping difficulty. Dr. Amara will review the sleep tips with the subjects and make recommendations for improving current sleep habits. Subjects will be contacted by telephone every 4 weeks during the 16-week intervention period.
15920359|NCT03495180|Other|Standard EEG or SSEP|The gamma frequency range (30 -100 Hz) of standard EEG or somatosensory evoked potential (SSEP) correlate with intensity of an experimental pain stimulus and perceived (self-rating, subjective) pain intensity.
15920360|NCT03495167|Drug|SyB C-1101|SyB C-1101 (rigosertib sodium) will be administered to two cohorts of patients; each receives either twice daily (560 mg before breakfast and 560 mg before dinner) or twice daily (840 mg before breakfast and 280 mg before dinner. SyB C-1101 will be administered orally twice daily for 21 consecutive days, followed by a 7-day observation period. The treatment period of 28 days (21 days of administration + 7 days of observation) constitutes 1 cycle.
15920361|NCT03495154|Device|Parietene DS Composite Mesh|All subjects enrolled will receive the Parietene DS Composite Mesh
15920362|NCT03495141|Behavioral|Supervision/Coaching|Supervision involves coaching the trainee on insertion and withdrawal technique in a standard colonoscopy in a novice trainee
15920363|NCT03495128|Other|Bed Rest|3 days of head down tilt (-6 degrees) bed rest
15920364|NCT03495128|Other|Reconditioning|daily resistance training (for 3 days) on one leg
15920365|NCT03495115|Device|MRI|A MRI uses a strong magnet to produce detailed pictures of the inside of your body.
15920366|NCT03495115|Device|RSI|RSI is a technique that aims to improve the pictures produced during a MRI exam.
15920367|NCT03495102|Drug|Dulaglutide|Administered SC
15920368|NCT03495089|Diagnostic Test|dermal electrochemical conductance (DEC)|The patient will undergo DEC quantification using the Sudoscan® device.(Sudoscan®, Impeto Medical, France)
15920369|NCT03495089|Diagnostic Test|Monofilament testing|Monofilament testing by Semmes-Weinstein 5:07 MFT (10 g),
15920514|NCT03493854|Drug|Cyclophosphamide|Cyclophosphamide 600 mg/m2 will be administered IV on Day 1 of each cycle of treatment (as part of ddAC Q2W or AC Q3W) for Cycles 1-4.
15920370|NCT03495076|Other|Saline injection|In the saline injection condition, acute neck pain will be induced via 0.5 ml hypertonic (5% NaCl) saline bolus injection which is a commonly used model of acute pain. Saline will be injected into the right (or left) trapezius muscle at the level of C7 cervical level. Injections will be performed by a physician under ultrasound imaging guidance to ensure that each single injection will be equally placed at the same depth. The side for the pain induction will be randomised across subjects. The place of needle insertion and corresponding point on the opposite side of the body will be covered by placing a small piece of adhesive plaster to ensure blinding.
15920371|NCT03495076|Other|Sham injection|In the sham-injection condition (nocebo comparator), a real needle will be shown to the participants to imitate and produce the anticipation of a pain experience. A pinprick sensation will be produced by a weighted stimulus applied perpendicularly to the skin without piercing the skin. A stimulus of 512 millinewtons (mN) will be used to produce a pinprick sensation and activation of cutaneous nociceptors. Adhesive tapes covering stimulation points will also be provided. The stimuli will be applied in exactly the same spot as the real injection in previous experimental condition.
15920372|NCT03495063|Dietary Supplement|Natural Caffeine|Consumption of 400mg of natural caffeine
15920373|NCT03495063|Dietary Supplement|Synthetic Caffeine|Consumption of 400mg of synthetic caffeine
15920374|NCT03495050|Device|Transcatheter Aortic Valve Implantation|Transcatheter treatment of bicuspid aortic stenosis with the Evolut Pro/XL platform
15920375|NCT03495037|Behavioral|Real World Strategy Training|The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
15920376|NCT03495037|Behavioral|Psychosocial Education|The active comparator uses an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants will receive factual information on brain structure and function, age-related cognitive changes, and general brain health issues and will spend time doing non-specific cognitive exercises including crossword and Sodoku puzzles. Homework will consist of reading assignments related to the session topics.
15920377|NCT03495024|Drug|Varenicline|Oral medication approved to facilitate smoking cessation
15920378|NCT03495011|Diagnostic Test|Breast MRI|Quantitative, multiparametric breast MRI
15920379|NCT03495011|Other|Laboratory Biomarker Analysis|Only patients with pure DCIS on surgical excision will have advanced pathologic markers and Oncotype Dx DCIS Score testing.
15920380|NCT03494998|Diagnostic Test|PAT-POPS|Emergency Department-specific screening tool
15920381|NCT03494985|Device|Experimental Oralbalance Moisturizing Gel|Participants placed approximately a half inch length of the gel onto the tongue and spread thoroughly using their tongue. Participants used their assigned treatment products for 28 days as specified on their diary/instructions, at least twice and no more than 5 times daily.
15920382|NCT03494985|Device|Biotene Original Oral Rinse|Participants rinsed their mouth with 15 milliliters (mL) of oral rinse for 30 seconds and spat out. Participants used their assigned treatment products for 28 days as specified on their diary/instructions, at least twice and no more than 5 times daily.
15920383|NCT03494985|Device|Biotene Moisturizing Mouth Spray|Participants sprayed one jet directly into their mouth. Participants used their assigned treatment products for 28 days as specified on their diary/instructions, at least twice and no more than 5 times daily.
15920384|NCT03494985|Other|Water|Participants were allowed to take only one measured sip of water (15 mL) 30 minutes before the supervised product use. After the supervised treatment at the site, participants assigned to the water only treatment were allowed to sip water as often as required.
15920385|NCT03494972|Drug|Tetracyclin ointment|During 3rd molar surgery
15920386|NCT03494959|Drug|Pentaglobin|Antimicrobial treatment active against the multidrug-resistant strain should be started in case of neutropenic fever (oral temperature ≥38.3°C or temperature ≥38.0°C sustained over a one-hour period). Patients should receive the best available first-line therapy, usually a combination therapy, based on the in vitro susceptibility results of the pre-treatment screening swab in combination to Pentaglobin 5ml/kg over a 12h i.v. infusion for 3 consecutive days. Empirical treatment should be subsequently streamlined according to microbiological results (both positive and negative). Pentaglobin should be started within 12h from the onset of fever, regardless of the presence of hemodynamic stability.
15920387|NCT03494946|Procedure|Liver transplantation|
15920388|NCT03494946|Drug|Chemotherapy|May include chemotherapy, TACE, SIRT or other available treatment options.
15920391|NCT03494920|Other|Direct endovascular clot retrieval|Direct endovascular clot retrieval within 4.5 hours of stroke onset
15920392|NCT03494920|Other|Bridging thrombolysis followed by ECR|Bridging thrombolysis followed by ECR within 4.5 hours of stroke onset
15920393|NCT03494907|Drug|Seltorexant|Participants will be administered oral dose of seltorexant over-encapsulated tablets on Day 1.
15920394|NCT03494907|Other|Placebo Matched to Seltorexant|Participants will be administered matching placebo to seltorexant tablets on Day 1.
15920395|NCT03494907|Other|Placebo Matched to Moxifloxacin|Participants will be administered oral dose of moxifloxacin placebo tablet on Day 1.
15920396|NCT03494907|Drug|Moxifloxacin Dose 1|Participants will be administered oral dose 1 of moxifloxacin on Day 1.
15920397|NCT03494894|Diagnostic Test|Middle meatus aspirations and sputum|Bacterial genotype sequencing analysis will be performed in patients with bacteriological concordance between upper and lower airways.
15920398|NCT03494881|Drug|Nucala|All study participants will receive Nucala (2) 100mg SQ injections administered at two different anatomical sites at week zero, 2,4,6, and 8 for a total of 5 doses.
15920400|NCT03494855|Device|SyMRI Software|The MDME sequence aims to provide whole absolute quantification of T1, T2, PD and B1 inhomogeneity in 5 minutes at typical clinical resolution (0.8 x 0.8 x 5mm). SyMRI software then allows a user to synthesize any almost image contrast (T1, T2, PD, FLAIR, IR, DIR, etc) by adjusting imaging parameters after the fact.
15920401|NCT03494842|Device|Transcutaneous nerve stimulation (TENS)|The active TENS unit (delivers electrical stimulation) with indicator light
15920402|NCT03494842|Device|Placebo Transcutaneous nerve stimulation (TENS)|the placebo TENS unit (delivers no electrical stimulation) with indicator light
15920403|NCT03494816|Drug|Axitinib Oral Tablet|"Axitinib is an oral VEGF-receptor inhibitor. Patients are prescribed a starting dose of 5mg twice daily, escalating to 10mg in absence of dose limiting toxicities and blood pressure.
~Doses should be taken approximately 12 hours apart and patients should be instructed to take their doses at approximately the same times each day with or without food as per instruction. On clinic days only, patients will be advised to fast for 6 hours prior to their clinic visit.
~Patients should be advised to stop axitinib treatment a minimum of 36 hours and maximum of 7 days prior to week 9 nephrectomy and thrombectomy surgery.
~Dose adjustments, including dose increase or dose reduction, are permitted and should be based on clinical judgement and the guidelines provided in the protocol."
15920404|NCT03494777|Behavioral|Incentivization based on high adherence|When a participant comes for a regular clinic visit, s/he will have the MEMS data extracted, and if adherence over the previous month >=90%, will participate in a prize drawing.
15920405|NCT03494777|Behavioral|Incentivization based on timely clinic visit|When a participant comes for a regular clinic visit on the day s/he is scheduled, s/he will participate in a prize drawing.
15920406|NCT03494777|Behavioral|Annual adherence prize drawing|Participants will have a chance to take part in an annual drawing where eligilbity is based on the average adherence during that year.
15920407|NCT03494777|Behavioral|Annual viral suppression-based prize drawing|Participants will have a chance to take part in an annual drawing where eligibility is based on showing viral suppression.
15920408|NCT03494777|Behavioral|Year 2 booster|Those participants not showing viral suppression at month 12 will be randomized in a 1:1 fashion to receive an additional intervention component or continue receiving the same intervention arm as in Year 1.
15920409|NCT03494764|Other|Hyperbaric Oxygen Therapy|Hyperbaric oxygen (HBO) provides 100% oxygen at a pressure above atmospheric pressure (typically twice to three times standard sea level pressure (2.0-3.0 ATA)). This dramatically increases the amount of oxygen dissolved in blood plasma, which in turn increases oxygen delivery to tissues. This effect of hyperbaric oxygen is used clinically to treat acute hypoxia in crush injuries, severed limbs, and failing skin grafts
15920410|NCT03494751|Device|Heart monitor|Use of heart monitor device in the patients after acute myocardium infarct.
15920411|NCT03494751|Device|No heart monitor|Standard monitoring by nurses.
15920412|NCT03494725|Dietary Supplement|Lpc-37|Lacticaseibacillus paracasei Lpc-37 at 1.75 x 10^10 colony forming units (CFU) per day, microcrystalline cellulose, magnesium stearate, silicon dioxide
15920413|NCT03494725|Dietary Supplement|Placebo|microcrystalline cellulose, magnesium stearate, silicon dioxide
15920414|NCT03494712|Drug|S 95010|Single administration of S 95010 in healthy volunteers
15920415|NCT03494712|Other|Placebo|Single administration of placebo in healthy volunteers
15920416|NCT03494699|Behavioral|Multidisciplinary prevention|group cognitive training (every month) App-based Cognitive Training at Home (using smartphone application) physical activity/body weight/smoking & alcohol cessation monitoring and feedback
15920417|NCT03494686|Procedure|LLETZ under local anaesthesia|Conization will be performed under local anaesthesia
15920418|NCT03494686|Procedure|LLETZ under general anaesthesia|Conization will be performed under general anaesthesia
15920419|NCT03494673|Diagnostic Test|BOLD MRI|"Prospective End-tidal targeting RespirAct device(A specially designed gas blender and sequential rebreathing circuit) will be used to implement the gas targeting method which involves precise elevations in End-tidal PCO2 while maintaining a fixed End-tidal PO2
~BOLD MR images will be obtained by using a T2*-weighted two-dimensional gradient-echo sequence with echoplanar readout."
15920420|NCT03494660|Device|Subchondroplasty Procedure with AccuFill|Injection of the commercially available flowable calcium phosphate (CaP) synthetic bone-void filler, AccuFill®, into subchondral bone defects in the hip (Subchondroplasty (SCP) Procedure).
15920421|NCT03494647|Device|Cheetah Heel Cup|At 1, 2, and 3 months, a study team member will email the subject's parent the OxAFQ-C and Visual Analog Scale (VAS). A reminder phone call will be made if the questionnaires have not been completed within 5 days.
15920422|NCT03494647|Device|The X Brace|At 1, 2, and 3 months, a study team member will email the subject's parent the OxAFQ-C and Visual Analog Scale (VAS). A reminder phone call will be made if the questionnaires have not been completed within 5 days.
15920423|NCT03494634|Drug|Chidamide|Chidamide 30mg orally BIW. Treatment cycles are repeated every 4 weeks.
15920424|NCT03494621|Behavioral|Protecting Babies While they Sleep Curriculum|The intervention curriculum derives from information gathered at previously conducted focus groups and interviews, which aimed to ascertain the role of caregiver knowledge, beliefs, and access to resources in implementation of infant safe sleep practices. .
15920425|NCT03494595|Procedure|Pediatric Liver transplantation|Pediatric Liver transplantation
15920426|NCT03494582|Procedure|Sacral Hysteropexy|Abdominal approach for uterine suspension
15920427|NCT03494582|Procedure|sacrospinous Hysteropexy|Transvaginal approach for uterine suspension
15920428|NCT03494569|Drug|Fludarabine|Given IV
15920429|NCT03494569|Other|Laboratory Biomarker Analysis|Correlative studies
15920430|NCT03494569|Drug|Melphalan|Given as per City of Hope Standard Operating Procedure
15920431|NCT03494569|Radiation|Total Marrow Irradiation|Undergo TMLI
15920432|NCT03494556|Other|Data Collection|Paramedic will use data collected during routine care to complete four risk stratification tools.
15920433|NCT03494543|Procedure|Endoscopic Papillectomy|Endoscopic resection of ampullary of Vater neoplasms
15920434|NCT03494530|Drug|Edoxaban 60 MG|Anticoagulant used to treat atrial fibrillation
15920435|NCT03494530|Drug|Edoxaban 30 mg|Anticoagulant used to treat atrial fibrillation
15920515|NCT03493854|Drug|Doxorubicin|Doxorubicin 60 mg/m2 will be administered IV on Day 1 of each cycle of treatment (as part of either ddAC Q2W or AC Q3W) for Cycles 1-4.
15920436|NCT03494517|Drug|Magnesium Sulfate|Baseline EEG measurement will be performed for 5 minutes before intravenous magnesium administration will start as defined by the administration scheme of the Women's Hospital of the Bern University Hospital. After completion of the bolus infusion and at the beginning of the maintenance infusion of magnesium the second EEG measure will be performed for another 5 minutes. After 4 hours of intravenous magnesium treatment the plasmatic magnesium concentration is expected to be at a steady-state. A third 5-minute measure will be performed at this time point.
15920437|NCT03494504|Drug|Reproxalap Ophthalmic Solution (0.25%)|Reproxalap Ophthalmic Solution (0.25%) administered once.
15920438|NCT03494504|Drug|Reproxalap Ophthalmic Solution (0.5%)|Reproxalap Ophthalmic Solution (0.5%) administered once.
15920439|NCT03494504|Drug|Vehicle Ophthalmic Solution|Vehicle Ophthalmic Solution administered once.
15920440|NCT03494491|Dietary Supplement|Chitin-glucan|Second test day (D2), subjects will received 4.5g of chitine-glucan
15920441|NCT03494491|Dietary Supplement|Maltodextrin|First test day (D0), subjects will received 4.5g of maltodextrin.
15920442|NCT03494478|Other|Neuropsychological testing|The assessment will will be done at the time of the initial evaluation (undiagnosed / untreated patients), then at one year of follow-up
15920443|NCT03494478|Other|Actimetry|The assessment will will be done at the time of the initial evaluation (undiagnosed / untreated patients), then at one year of follow-up.
15920444|NCT03494478|Other|Self-questionnaires on emotional topics|The assessment will will be done at the time of the initial evaluation (undiagnosed / untreated patients), then at one year of follow-up.
15920445|NCT03494465|Procedure|PHACOEMULSIFICATION|"Standard phacoemulsification with intraocular lens implant will be perform within 60 days after allocation. If IOP target is not achieve, patients will be treated as in medical treatment group"
15920446|NCT03494465|Drug|MEDICAL GLAUCOMA TREATMENT|The escalation of topical hypotensive medications will be carried out with the following sequence: 1. single topical medication; 2. double topical therapy; 3. triple topical therapy. Beginning, with the exception of individual contraindications, with prostaglandin analogs, followed by topical beta-blockers, carbonic anhydrase inhibitors and finally alpha-agonists.Target IOP will be used in both groups to inform the need of escalation of therapy; in patients with ocular hypertension the target IOP will be 21 mmHg. In patients with mild glaucoma target IOP will be 18 mmHg, and in patients with moderate glaucoma the target IOP will be 15 mmHg.
15920447|NCT03494452|Other|No intervention|There is no intervention in this cross-sectional study
15920448|NCT03494426|Procedure|radiofrequency thoracic sympathectomy|"Under fluoroscopic guidance thoracic sympathectomy will be done as follow
~antroposterior view of upper thoracic vertebrae ,cephalo-caudal adjustment of C - arm until aliment of endplates of T2 and T3
~oblique view 20 degree under tunnel view RF 10cm 20G 1mm active tip needle is introduced intimately related to vertebral margin
~the depth of the needle will be determined under lateral fluoroscopic view the needle is advanced step by step hugging the lateral vertebra l margin until the tip of the needle situated at the middle of the vertebral body . RF lesion 2min 80c will be done and needle is rotated 90 degree on both sides and another two lesions will be done at the end of the procedure 2ml of lidocaine and 20mg of triamcinolone will be injected at each level Post procedure analgesic protocol consisted of either increase or decrease, according to intensity of pain by 50 mg pregabalin and 50 mg tramadole and 25 mg tryptazole, individualized for each patient."
15920449|NCT03494426|Drug|pregabalin ,tramadol,and tricyclic antidepressants|patient will receive anti neuropathic medications
15920450|NCT03494413|Diagnostic Test|Transpharyngeal Doppler sonography (TPS)|Usage of transpharyngeal Doppler to assess cerebral perfusion during cardiovascular surgery
15920451|NCT03494413|Diagnostic Test|Conventional colour-coded Duplex sonography (CDS)|Usage of conventional colour-coded Duplex sonography (CDS) to assess cerebral perfusion during cardiovascular surgery
15920452|NCT03494400|Other|Aerobic Training Presential|The intervention will last 24 weeks, in which the presential training group will undergo aerobic training three times a week on interspersed days, more follow-up.
15920453|NCT03494400|Other|Aerobic Training Home-based|The intervention will last 24 weeks, the group accompanied by the distance will carry out the activities in their preferred place under the distance supervision of professionals and every 14 days must attend the UNESP to adjust the intensity and verification of attendance to the proposed activities, more follow-up.
15920454|NCT03494387|Drug|Oxygen|80% versus 30% inspiratory oxygen concentration
15920455|NCT03494387|Drug|Antioxidants|Antioxidants versus placebo
15920456|NCT03494374|Device|UCBL orthosis|toe walking exercise
15920457|NCT03494348|Device|Medial Congruent Polyethylene (MC)|One group receives the conventional CR surface and the other the new MC articular surface
15920459|NCT03494322|Drug|Avelumab|Avelumab 10 mg/kg given IV
15920460|NCT03494322|Drug|Cetuximab|"Cetuximab 500* mg/m2 given IV
~*Cetuximab dose will be dependent on outcome of safety run-in."
15920461|NCT03494309|Procedure|Open Reduction & Internal Fixation|Patients underwent surgery and the fractures were reduced under direct vision followed by internal fixation with titanium plates and screws
15920462|NCT03494309|Procedure|Closed Reduction & External Fixation|Patients underwent closed reduction of the fracture and external fixation by arch bars & guided elastics
15920463|NCT03494296|Drug|patients received D-COP regimen chemotherapy|patients received D-COP regimen chemotherapy
15920464|NCT03494283|Behavioral|Practice Behaviour|Improve and modify practice of the practicers and of the professionals who are framing to decrease the injury incidence.
15920465|NCT03494270|Drug|Rosuvamibe|Rosuvastatin 10mg/Ezetimibe 10mg
15920466|NCT03494270|Drug|Monorova|Rosuvastatin 20mg
15920467|NCT03494257|Drug|Brinzolamide-Brimonidine fixed combination|Simbrinza 0.2%-1% Ophthalmic Suspension
15920468|NCT03494244|Procedure|Direct-to-implant breast reconstruction|Terminal prosthetic implanted at the time of mastectomy.
15920469|NCT03494244|Device|Acellular dermal matrix|Banked tissue used to support the directly implanted breast prosthesis.
15920470|NCT03494231|Drug|HLX06|recombinant fully human anti-VEGFR2 monoclonal antibody against cancers
15920471|NCT03494218|Diagnostic Test|Nociception Coma Scale (NCS)|Patients have been assessed with both the Nociception Coma Scale (NCS) and the FLACC.
15920547|NCT03493646|Drug|Azacitidine|75mg/m2 per day for 7 days of each 28 day cycle. Cycles 1-6
15920472|NCT03494205|Drug|Urtica comp. gel|"Urtica comp. gel is a Swissmedic registered medication. The scope of application of Urtica comp. is an imbalanced, affected process of skin-regeneration, in particular when stemming from an overdose of heat or light.
~It is applied in first and second-degree burn and scalding, sunburn, allergic and hyperergic (excessive) skin conditions (dermatoses), insect bites, abrasions and ulcers."
15920473|NCT03494205|Drug|"institutional standard skin care Excipial-Hydrolotion"|"The institutional standard skin care Excipial-Hydrolotion is available to all patients"
15920474|NCT03494192|Other|scapula based|physiotherapy program consists of cold pack, supervised stretching and scapulothoracic muscles strengthening exercises and home exercise programme including stretching and strengthening exercises will be applied two times a week total 24 sessions
15920475|NCT03494192|Other|scapula&rotator cuff based|physiotherapy program consists of cold pack, supervised stretching and scapulothoracic and also rotator cuff muscles strengthening exercises and home exercise programme including stretching and strengthening exercises will be applied two times a week total 24 sessions
15920476|NCT03494179|Drug|ICP-022|The drug product is a white, round, uncoated tablet.
15920477|NCT03494166|Behavioral|Telephone Interpersonal Counseling (TIP-C)|See arm/group descriptions
15920478|NCT03494153|Other|Non applicable - Non interventional study|Non interventional study
15920479|NCT03494140|Device|Viscontour® Serum Med|Viscontour® Serum Med is a CE-certified preservative-free isotonic solution containing 5.0 mg sodium hyaluronate.
15920480|NCT03494127|Device|Use of GEL BALL FITTED MODULAR CUSHION|DAILY COMMUNITY USE OF GEL BALL FITTED MODULAR CUSHION for 2 weeks
15920481|NCT03494127|Device|Use of SQUISHINS FITTED MODULAR CUSHION|DAILY COMMUNITY USE OF SQUISHINS FITTED MODULAR CUSHION for 2 weeks
15920482|NCT03494114|Drug|Ga-EC2115|Ga-EC2115 will be administered by IV injection prior to PET/CT imaging.
15920483|NCT03494101|Other|Blood samples|Blood samples will be collected and analyzed at different study time points
15920484|NCT03494101|Other|Stool samples|Stool samples will be collected and analyzed at different study time points
15920485|NCT03494101|Other|Clinical information|Clinical information will be collected at different study time points using questionnaires
15920486|NCT03494062|Behavioral|Exercise|Home-based exercise training
15920487|NCT03494049|Procedure|Veil sparring HoLEP|"Early mucosal incision; lateral to the Veru and proximal to the apical bulge of the adenoma, followed by early separation of the adenoma from the sphincter ring after identification of the plane of enucleation, this minimizes sphincter stretch.
~Furthermore, more proximal incision of the 12 O'clock mucosal strip sparring a veil of mucosa covering the sphincter ring."
15920488|NCT03494049|Procedure|Standard HoLEP|Holmium laser enucleation of the prostate in the standard approach described by Elhilali et al 2010
15920489|NCT03494036|Dietary Supplement|Synbiotic|capsule
15920490|NCT03494036|Dietary Supplement|Placebo|capsule
15920491|NCT03494023|Diagnostic Test|Endoscopic ultrasound|Measurement of the common bile duct diameter
15920492|NCT03494010|Other|Observation|There is no intervention. Patients will receive the HCL system as part of their clinical care.
15920493|NCT03493997|Combination Product|Radiotherapy+IAluril®+Ialuril Soft Gels®|Radiotherapy+IAluril®+Ialuril Soft Gels®
15920494|NCT03493997|Radiation|Radiotherapy only|Radiotherapy only
15920495|NCT03493984|Other|Ginger exosomes|Naturally occurring plant exosomes from ginger
15920496|NCT03493984|Other|Aloe exosomes|Naturally occurring plant exosomes from aloe
15920497|NCT03493984|Other|Placebo|Exosome placebo tablet
15920498|NCT03493971|Procedure|Carotid revascularization performed using CAS|Carotid artery stenting (CAS) is an endovascular stent procedure used to treat narrowing of the carotid artery and decrease the risk of stroke
15920499|NCT03493971|Procedure|Carotid revascularization performed using CEA|Carotid endarterectomy (CEA) is a surgical procedure used to correct stenosis in the common carotid artery or internal carotid artery and reduce the risk of stroke
15920507|NCT03493932|Drug|Nivolumab|OPDIVO is a human programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
15920508|NCT03493932|Drug|BMS-986016|Anti-Lymphocyte Activation Gene-3 antibody undergoing clinical evaluation by Bristol-Myers Squibb
15920511|NCT03493906|Other|Patient Ambassador Support|Patient Ambassador Support, with former patient treated for acute leukaemia being ambassadors for newly diagnosed patients for a period of 12 weeks.
15920512|NCT03493893|Device|Intermedullary nail|investigate the clinical effects of these design changes from the use of three different IM nail designs in the management of extracapsular hip fractures.
15920513|NCT03493867|Device|Vitaliti|Measurements recorded by the Vitaliti device will be compared to the recordings from the arterial catheter.
15920776|NCT03491982|Device|Remote Cardiac Rehab|Remote Cardiac Rehab
15920516|NCT03493854|Drug|Docetaxel|As part of one of the two investigator's choices of chemotherapy (AC followed by docetaxel), docetaxel 75 mg/m2 will be administered IV on Day 1 of Cycle 5 and then 100 mg/m2 IV at the discretion of the investigator for Cycles 6-8 (Q3W), if no dose-limiting toxicity occurs.
15920517|NCT03493854|Drug|Paclitaxel|As part of one of the two investigator's choices of chemotherapy (ddAC followed by paclitaxel), paclitaxel 80 mg/m2 will be administered IV QW for 12 weeks.
15920518|NCT03493854|Drug|Pertuzumab IV|Pertuzumab will be administered as a fixed non-weight-based dose of 840-mg IV loading dose and then 420-mg IV maintenance dose Q3W.
15920519|NCT03493854|Drug|FDC of Pertuzumab and Trastuzumab SC|The FDC of pertuzumab and trastuzumab will be administered SC at a fixed non-weight-based dose. A loading dose of 1200 mg SC pertuzumab and 600 mg SC trastuzumab is then followed by a maintenance dose of 600 mg SC pertuzumab and 600 mg SC trastuzumab Q3W.
15920520|NCT03493854|Drug|Trastuzumab IV|Trastuzumab will be administered as an 8-mg/kg IV loading dose and then 6 mg/kg IV maintenance dose Q3W.
15920521|NCT03493854|Drug|Trastuzumab SC|After surgery (from Cycle 9 onwards), participants in Arm A will be allowed to switch from trastuzumab IV to trastuzumab SC, at the discretion of the investigator, in the countries where trastuzumab SC is routinely used. For participants who switch, a fixed dose of 600 mg trastuzumab SC (irrespective of the patient's weight) will be administered in the adjuvant phase.
15920522|NCT03493854|Procedure|Surgery|Participants in both cohorts are scheduled to undergo surgery after 8 cycles of neoadjuvant therapy. Participants may undergo breast-conserving surgery or mastectomy according to routine clinical practice.
15920523|NCT03493854|Radiation|Post-operative Radiotherapy|If indicated, radiotherapy is given after chemotherapy and surgery, during adjuvant HER2-targeted therapy and hormone therapy (for hormone-receptor positive disease).
15920524|NCT03493854|Drug|Hormone Therapy|For hormone receptor positive breast cancer, tamoxifen or aromatase inhibitors will be allowed as adjuvant hormone therapy for postmenopausal participants and with ovarian suppression or ablation for premenopausal participants in countries where it has been registered for this indication. Its use must be consistent with the registered label. Hormone therapy is given after chemotherapy and surgery during adjuvant HER2-targeted therapy.
15920525|NCT03493841|Drug|Alpha Lipoic Acid|Lipoic acid is an over the counter supplement. Two different forms, R and racemic are available. R-lipoic acid is the naturally occurring form. Racemic lipoic acid is the most commonly available supplement.
15920526|NCT03493828|Procedure|TAP block using Bupivacaine 0.5%|Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of Bupivacaine 0.5% was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.
15920527|NCT03493828|Procedure|TAP block using Bupivacaine 0.25%|Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of Bupivacaine 0.25% was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.
15920528|NCT03493828|Procedure|TAP block using Normal Saline|Following completion of the Cesarean delivery, the abdomen was aseptically prepped with ChloraPrep®. A Sonosite ultrasound machine (S-nerve) with a 14-8 MHz linear probe was used to visualize the lateral abdominal wall muscles and transversus abdominis plane. A 2 or 4 inch stimuplex (Braun) needle was advanced under ultrasound guidance to the transversus abdominis plane. After negative aspiration, 15 ml of normal saline was incrementally injected on each side. The spread of solution within the transversus abdominis plane was visualized with the ultrasound.
15920529|NCT03493815|Procedure|Transabdominal Ultrasound Guided IUD Insertion|Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
15920530|NCT03493815|Procedure|Traditional Blind IUD Insertion|Comparing the utility of ultrasound-guided intrauterine device (IUD) insertion compared to traditional blind insertion
15920531|NCT03493789|Drug|Fludeoxyglucose F-18|Given IV
15920532|NCT03493789|Procedure|Positron Emission Tomography (PET)|Undergo FDG-PET
15920533|NCT03493789|Radiation|Stereotactic Body Radiation Therapy (SBRT)|Undergo SBRT
15920534|NCT03493776|Biological|VZV subunit vaccine|VZV subunit vaccine
15920535|NCT03493763|Diagnostic Test|5hmC profile in plasma cell-free DNA after liver resection|Peripheral blood is drawn every 3 months after liver resection for 5hmC test (Time frame: 2 years or until tumor recurrence).
15920536|NCT03493750|Other|Oral and dental evaluation|Mouth inspection done by a nurse, in order to count missing, coloured, injured teeth, and evaluate dental plaque, halitosis, inflammatory gums, mucosal injuries, low masticatory surface.
15920537|NCT03493737|Behavioral|Quality of life surveys|Quality of life surveys by EQ-5D and QLQ-C30
15920538|NCT03493724|Other|telemedecine|to evaluate the diagnostic performance of the photographs made by Smartphone, during requests for emergency dermatological advice
15920539|NCT03493698|Drug|Midazolam|Midazolam
15920540|NCT03493698|Drug|Inarigivir|Inarigivir
15920541|NCT03493685|Drug|sparsentan|Double-blind period: target dose of 800 mg daily; Open-label extension: target dose based on dosage from week 114 daily
15920542|NCT03493685|Drug|Irbesartan|target dose of 300 mg daily
15920543|NCT03493672|Diagnostic Test|Objective measurement of physical activity and fitness|Physical activity and fitness will be assessed objectively with a smartphone
15920544|NCT03493659|Behavioral|Standing during Concept Test|The participants will stand with a standing desk at an ergonomically correct height during the administration of the Concept Test.
15920545|NCT03493659|Behavioral|Standing during regular tutorial session|The participants will stand with a standing desk at an ergonomically correct height during their regular tutorial sessions.
15920546|NCT03493659|Behavioral|Standing during Concept Test and regular tutorial session|The participants will stand with a standing desk at an ergonomically correct height during the administration of the Concept Test and during their regular tutorial sessions.
15920548|NCT03493646|Drug|CC-486|100 mg BID for the first 21 days of each 28-day treatment cycle (cycles 7-8). The dose should be increased from cycle 9 onwards to 150mg BID for the first 21 days of each 28-day treatment cycle (cycles 9-12) in the absence of Grade 3 or 4 AE. If 2 or more cycles are tolerated at this dose, further increments are permitted for patients with Stable Disease or if clinically indicated in consultation with the coordinating investigator as per the study dose modification schedule.
15920549|NCT03493633|Device|EzyGain|"Each patient performs a minimum of 3 sessions per week with the investigator / APA investigator, for 4 weeks, each walk for a few minutes (<60 min).
~Evaluation of the spontaneous physical activity of the patient by actimetry for seven days QAPPA (questionnaire of physical activity for elderly person) a week and a month after the training phase of four weeks"
15920550|NCT03493620|Procedure|Device arm|Make a gastric tube (endoscopic sleeve gastroplasty) using the Apollo Overstitch suturing device through endoscopy.
15920551|NCT03493620|Procedure|Sham arm|Group II will be conducted identically to Group I except for the procedure itself, and only the endoscopist, that is the researcher, will be aware of which group each patient belongs to.
15920552|NCT03493607|Drug|AMO-01|Subjects will receive a single 6-hour intravenous infusion for a total dose administration or 120 mg/m2 of AMO-01.
15920553|NCT03493594|Other|Nutrition education program|online platform support, workshop, seminar and cooking demo etc
15920554|NCT03493581|Procedure|BIOPSY|re-biopsy (primitive tumor or metastasis) specifically for the study, at V2(6 weeks)
15920555|NCT03493581|Diagnostic Test|blood-sampled|"after 3 or 4 weeks (V1-1st assessment of PK/PD, after the 2d course),
~after 6 weeks (V2),
~after 8 or 9 weeks (V3-2nd assessment of PK/PD, after the last course),
~- after 12 weeks of treatment (V4- samples for 3rd assessment of PK/PD and other analyses ).
~after 18 weeks (V5- samples for 4th assessment of PK/PD and other analyses,),
~after 24 weeks of treatment (V6-5th assessment of PK/PD and other analyses)."
15920556|NCT03493581|Other|feces samples|If they are amenable to collect feces samples at home, an auto collection kit will be supplied to them, before the first injection (Vs) and when they come for the 2nd course (i.e after 3 or 4 weeks post initiation) in order to self-collect feces within the week beforeV2 - 6 weeks post initiation).
15920557|NCT03493568|Drug|Genvoya 150Mg-150Mg-200Mg-10Mg Tablet|switch to Genvoya 150Mg-150Mg-200Mg-10Mg Tablet in patients virologically suppressed HIV-1 infected patients.
15920558|NCT03493568|Drug|Dolutegravir 50 mg plus one RTI|Continuing Dolutegravir 50 mg (1 pill every 24 hours) plus one RTI (at label dose)
15920559|NCT03493555|Behavioral|Peer Health Navigator for PrEP|Peer health systems navigator to improve adherence to PrEP
15920560|NCT03493542|Biological|V501|0.5 mL intramuscular injection in the deltoid muscle at Day 1, Month 2, and Month 6
15920561|NCT03493516|Diagnostic Test|PET scan quantifying sympathetic denervation using [18F]-LMI1195|A cardiac PET scan will be obtained to quantify the percentage of the left ventricle that is denervated and has reduced uptake of the sympathetic nerve tracer [18F]-LMI1195
15920562|NCT03493503|Drug|Salbutamol|Intravenous Salbutamol loading dose
15920563|NCT03493503|Drug|Sodium Chloride 0.9%|10 ml of Sodium Chloride 0.9% in 10 minutes intravenous
15920564|NCT03493490|Drug|Neodolpasse|Patients will receive two infusions containing 75 mg diclofenac and 30 mg orphenadrine citrate 30 minutes after fixation of the graft replacement and with a time interval of 8 hours.
15920565|NCT03493490|Drug|Diclofenac|Patients will receive two infusions containing 75 mg diclofenac 30 minutes after fixation of the graft replacement and with a time interval of 8 hours.
15920566|NCT03493490|Drug|Placebo|Patients will receive two physiologic saline infusions 30 minutes after fixation of the graft replacement and with a time interval of 8 hours.
15920567|NCT03493477|Other|exposure will be abnormal skeletal jaw relations|Class II skeletal jaw relation or class III skeletal jaw relation based on lateral cephalometric radiograph
15920568|NCT03493464|Drug|BR55|A novel targeted ultrasound contrast agent
15920569|NCT03493451|Drug|Tislelizumab|200 mg IV on Day 1 of each 21-day cycle.
15920570|NCT03493438|Other|exercise|A hot pack and conventional transcutaneous electrical stimulation (TENS) will be applied with a Chattanoga Intelect® stimulator for 20 minutes at a frequency of 100 Hz and a transition time of 60 μs. The duration of application was 3 days per week and six weeks for each of the four groups. These practices were also applied to individuals in all four groups.
15920571|NCT03493425|Drug|Carboplatin|Given IV
15920572|NCT03493425|Drug|Cisplatin|Given IV
15920573|NCT03493425|Drug|Docetaxel|Given IV
15920574|NCT03493425|Radiation|Image Guided Radiation Therapy|Undergo image guided IMRT
15920575|NCT03493425|Radiation|Intensity-Modulated Radiation Therapy|Undergo image guided IMRT
15920576|NCT03493425|Other|Laboratory Biomarker Analysis|Correlative studies
15920577|NCT03493425|Other|Questionnaire Administration|Ancillary studies
15920578|NCT03493425|Procedure|Therapeutic Conventional Surgery|Undergo standard of care surgery
15920579|NCT03493412|Drug|Sapropterin Dihydrochloride (BH4, tetrahydrobiopterin)|5 mg/kg will be used as the dose of BH4
15920580|NCT03493412|Drug|Placebo|Placebo
15920581|NCT03493399|Behavioral|Interference|"The principle of interference-based techniques is to move the resources allocated to the elaboration of intrusive desire thoughts to a competing task (e.g., clay modelling, competitive mental imagery, Tetris) in order to monopolize the resources underlying craving, thus preventing its elaboration and reducing its vividness and overwhelming nature. Several studies (Andrade, Pears, May, & Kavanagh, 2012; May, Andrade, Panabokke, & Kavanagh, 2010; Skorka-Brown, Andrade, Whalley, & May, 2015) have shown the efficacy of such techniques to reduce substance-related craving. Yet, data obtained on clinical samples remain scarce.
~Due to the flexibility of the single case design towards each participant, the list of interference-based techniques that will be used in this study cannot be exhaustive. However, the following will be proposed to participants: Tetris (smartphone version), manipulation of a bunch of keys, manipulation of a fidget, mental imagery, reading and memorizing a text."
15920582|NCT03493386|Drug|Daprodustat 2 mg tablet|Daprodustat is available as 2 mg tablet. Subjects will receive daprodustat orally as tablet. A single dose of 2 tablets of 2 mg daprodustat will be administered in a fasted state during Part 1 of the study.
15920583|NCT03493386|Drug|Daprodustat 4 mg tablet|Daprodustat is available as 4 mg tablet. Subjects will receive daprodustat orally as tablet. A single dose of 4 mg daprodustat will be administered in a fasted state during Part 1 and in fed and fasted state in Part 2 of the study.
15920584|NCT03493373|Other|Exercise|The exercise program will consist of: 1) warm up - consisting of stretches of large muscle groups of the upper limbs, lower limbs and trunk and by general mobility exercises; 2) strength training of moderate intensity; 3) balance training; 4) Cooling - will consist of performing overall stretching combined with deep breathing.
15920585|NCT03493373|Other|Neural mobilization|Neural gliding mobilization will target mainly the lower limb nerves and will be performed in series of 10 repetitions with 1 minute interval between series.
15920586|NCT03493360|Other|Visual feedback|Participants will be asked to perform 10 repetitions of low back flexion, extension and lateral side-flexions while looking at their back in a mirror for visual feedback.
15920587|NCT03493360|Other|No visual feedback|Participants will be asked to perform 10 repetitions of low back flexion, extension and lateral side-flexions while looking at a mirror that is covered and no visual feedback is provided.
15920588|NCT03493347|Behavioral|Equine-assisted Occupational Therapy|Occupational therapy provided in an equine environment that includes activities such as groundwork, grooming, tacking, mounting, and riding horses
15920589|NCT03493334|Other|Visual feedback|Visual feedback of the neck will be given to participants using two mirrors while performing neck movements.
15920590|NCT03493334|Other|No visual feedback|Participants will be asked to perform active movements of their neck with the mirrors covered.
15920591|NCT03493321|Other|PRF with Theracal|using the PRF which is a new technique with an bioactive material which is the Theracal to evaluate its effect upon the radicular pulp tissue
15920592|NCT03493308|Other|Pain neuroscience education|PNE will be conducted in line with international guidelines and will cover the neurophysiology of pain, transition from acute to chronic pain and the nervous system ability to modulate the pain experience.
15920593|NCT03493308|Other|Exercise|Exercise will be provided in different formats including general exercise, strengthening, dance.
15920594|NCT03493295|Drug|Levonogestrel IntraUterine System (LNG-IUS)|At the routine clinical practice. Jaydess, Mirena, Kyleena Or any other levonogestrel intrauterine system (LNG-IUS) commercialized in Spain at the start of the study, only for contraception indication.
15920595|NCT03493282|Drug|Active Treatment- CT1812 100 mg|Active Study Drug
15920596|NCT03493282|Drug|Placebo|Non-active study drug
15920597|NCT03493282|Drug|Active Treatment- CT1812 300 mg|Active Study Drug
15920598|NCT03493269|Drug|BAY1834845|Orally administered.
15920599|NCT03493269|Other|Matching Placebo|Orally administered.
15920600|NCT03493269|Drug|Midazolam|Part 1: Orally administered 1mg as a single dose.
15920601|NCT03493256|Other|exposure to type 2 neurological complications|exposure to postoperative cognitive dysfunction (POCD) or postoperative delirium (POD), or both concurrently.
15920602|NCT03493243|Other|Questionnaires|2-hour clinical observation
15920603|NCT03493230|Biological|quantification of BRAF and NRAS mutation|Quantification of cell-free BRAF and NRAS mutations with digital PCR
15920604|NCT03493217|Drug|ICP-022|The drug product is a white, round, uncoated tablet.
15920605|NCT03493204|Other|Meal delivery|The food will be pre-packaged for storage and patient will prepare these meals at home
15920606|NCT03493204|Other|Standard pamphlet with Dietary Advice|Explains how to maintain a low-sodium diet
15920607|NCT03493191|Drug|0.5μg/kg SHR0410|a single dose of 0.5μg/kg SHR0410
15920608|NCT03493191|Drug|1μg/kg SHR0410|a single dose of 2μg/kg SHR0410
15920609|NCT03493191|Drug|2μg/kg SHR0410|a single dose of 2μg/kg SHR0410
15920610|NCT03493191|Drug|5μg/kg SHR0410|a single dose of 5μg/kg SHR0410
15920611|NCT03493191|Drug|10μg/kg SHR0410|a single dose of 10μg/kg SHR0410
15920612|NCT03493191|Drug|20μg/kg SHR0410|a single dose of 20μg/kg SHR0410
15920613|NCT03493178|Dietary Supplement|N- acetylcysteine plus Glycine v Placebo (alanine)|Dietary Supplement: Cysteine (as n-acetylcysteine) and glycine, or alanine. Subjects will receive 12wks of supplements.
15920614|NCT03493165|Drug|Everolimus|mTOR inhibitor
15920615|NCT03493152|Drug|Everolimus|mTOR inhibitor
15920616|NCT03493139|Behavioral|Physical Activity Across the Curriculum|Activity breaks will be designed for delivery in the classroom without reconfiguration of the classroom space. Activities will emphasize whole body movements, using large muscle groups. Each break includes multiple activities. Each activity lasts about 2 minutes. There will be a total of about 20 minutes of physical activity done each school day.
15920617|NCT03493126|Drug|Estradiol|17β-estradiol vaginal cream
15920618|NCT03493126|Other|Placebo|Compounded placebo cream
15920619|NCT03493113|Diagnostic Test|EEG|
15920620|NCT03493100|Dietary Supplement|oral nutritional supplementation|The intervention group will receive optimized nutritional support, by ONS. While hospitalized each patient receives 2 portions of oral supplementation per day. For remaining days supplementation is calculated individually according to a sarcopenia/energy balance schema resulting in none or maximum 2 portions per day.
15920621|NCT03493100|Other|Usual care|The control group will receive treatment according to usual care.
15920622|NCT03493087|Dietary Supplement|Menakinon 7|Menakinon 7 - One tablet a day against vitamin K deficiency
15920623|NCT03493087|Dietary Supplement|Diet rich in vitamin K|Diet with large content of vegetables and dairy products
15920624|NCT03493074|Diagnostic Test|Noninvasive pulse wave analysis sensor, ECG-sensor|The sensors are noninvasively attached
15920625|NCT03493061|Drug|Irinotecan|Irinotecan 150 mg/m2 IV over 90 minutes on Day 1, 15
15920626|NCT03493061|Drug|Oxaliplatin|Oxaliplatin 85 mg/m2 over 3 hours will be administered through the HAI pump on day 1. Oxaliplatin 85 mg/m2 IV over 3 hours on day 15.
15920627|NCT03493061|Drug|Floxuridine|0.12 mg/kg/day floxuridine (FUDR) and 25 mg dexamethasone in normal saline to a total volume of 300 ml will be administered through the HAI pump.
15920628|NCT03493048|Drug|Irinotecan|Irinotecan 130 mg/m²
15920629|NCT03493048|Drug|Cetuximab|Cetuximab, iv, 500mg/m2
15920630|NCT03493048|Drug|5-fluorouracil|5-FU 2400 mg/m² cont. inf.
15920631|NCT03493048|Drug|Oxaliplatin|oxaliplatin 85 mg/m²
15920632|NCT03493048|Drug|Leucovorin|leucovorin 200 mg/m²
15920633|NCT03493035|Diagnostic Test|Computed tomography angiography (3D CTA)|CTA scans data in DICOM format was used to morphometric analysis of aneurysmal and non-aneurysmal MCA bifurcations.
15920777|NCT03491969|Drug|Alpha-Lipoic Acid(α-LA)|200 mg, po, tid
15920634|NCT03493035|Diagnostic Test|Transcranial color-coded sonography (TCCS)|TCCS was used to assess of hemodynamic parameters of aneurysmal and non-aneurysmal MCA bifurcations.
15920635|NCT03493022|Other|Test Granola|50.5 Test Granola
15920636|NCT03493022|Other|Control Granola|54.3 Control Granola
15920637|NCT03493009|Device|Pure-Vu System|The Pure-Vu System is Food and Drug Administration (FDA) approved device since September 22, 2016, intended to connect to standard colonoscopes to help facilitate intra-procedural cleaning of a poorly prepared colon by irrigating or cleaning the colon and evacuating the irrigation fluid (water), feces and other bodily fluids and matter, e.g. blood.
15920638|NCT03492996|Drug|LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose|To assess the absorption, metabolism, excretion of LCB01-0371 after a single oral LCB01-0371 dose with a [14C]-LCB01-0371-tracer dose to healthy subjects
15920639|NCT03492983|Dietary Supplement|Intervention group|10 g/day of high cocoa content chocolate for six months.
15920640|NCT03492970|Biological|Hourly dosing of the nychtemeral secretion of melatonin|Hourly dosing of the nychtemeral secretion of melatonin links and with sleep disorders and behavior of adult patients with SMS
15920641|NCT03492957|Other|Physical activity|A tailored, person-centred, 12-week, chair-based exercise intervention to increase physical activity and fitness. Dose: one face-face session with a qualified physiotherapist plus two independent sessions per week. This is combined with education on self-management, self-efficacy and lifestyle change.
15920642|NCT03492944|Drug|Ultrasound Microbubble Contrast Agent|Patients undergoing a clinically ordered CT or MRI Enterography for Crohn disease will be recruited to undergo a contrast enhanced ultrasound study of the bowel
15920643|NCT03492944|Device|Ultrasound Imaging|Patients undergoing a clinically ordered CT or MRI Enterography for Crohn disease will be recruited to undergo a contrast enhanced ultrasound study of the bowel
15920644|NCT03492931|Drug|Ticagrelor|Patients will receive a single dose of ticagrelor
15920645|NCT03492918|Drug|Pembrolizumab|"Trial treatment should be administered on Day 1 of each cycle after all procedures/assessments have been completed as detailed on the Trial Flow Chart. Trial treatment may be administered up to 3 days before or after the scheduled Day 1 of each cycle due to administrative reasons.
~All trial treatments will be administered on an outpatient basis. Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks. Sites should make every effort to target infusion timing to be as close to 30 minutes as possible. However, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min)."
15920646|NCT03492905|Behavioral|Internet-based Cognitive Behaviour Therapy (iCBT)|Guided self-help for 7 weeks. Contact with therapist 2 times per week.
15920647|NCT03492892|Device|Acupuncture|Stimulate acupoint with filiform needles to restore the healthy condition of patients
15920648|NCT03492892|Device|Sham Acupuncture|Stimulate non-acupoint with filiform needles to treat the condition of patients
15920649|NCT03492879|Device|EIT Technology|Electrical Impedance Technology is a non-invasive imaging method who is being tested for evaluation of liver fibrosis stage
15920650|NCT03492866|Drug|Gentamicin Sulfate|Topical treatment of 1 side of the scalp twice daily during 6 months
15920651|NCT03492853|Genetic|DNA extraction and sequencing|DNA extraction from peripheral blood and KASP sequencing
15920652|NCT03492840|Drug|RZL-012|Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 2-16 sites (0.1mL per site) into the subcutaneous fat.
15920653|NCT03492827|Drug|chlorhexidine acetate gargle|observe whether it can achieve the effect of preventing postoperative infection
15920654|NCT03492814|Procedure|partial wound closure|3 sutures distal to second molar and leaving the vertical releasing incision open without any sutures.
15920655|NCT03492814|Procedure|total wound closure|5 interrupted sutures with 2 sutures closing the vertical releasing incision and 3 sutures distal to second molar leading to a complete hermetic closure of the wound.
15920656|NCT03492801|Procedure|Biospecimen Collection|Undergo collection of blood samples
15920657|NCT03492801|Other|Laboratory Biomarker Analysis|Correlative studies
15920658|NCT03492788|Other|ECGI-optimized VV-offset|ECGI guided optimization of VV offset programming of CRT device
15920659|NCT03492788|Other|Zero VV-offset|Standard-of-care nominal (zero VV-offset) programming of CRT device
15920660|NCT03492775|Drug|Obinutuzumab|Obinutuzumab (GA 101) is a first-in-class, potent, intravenously administered type II anti-CD 20 antibody that is developed by Roche AG for the treatment of B-cell malignancies.
15920661|NCT03492775|Drug|Bendamustine|Bendamustine belongs formally to the alkylators, but has been shown to have a unique mechanism of action. The dose limiting toxicity of bendamustine is its reversible suppression of bone marrow function with drops in leukocyte and thromobocyte counts.
15920662|NCT03492762|Drug|64Cu-DOTA-ECL1i|Radiolabeled probe called 64Cu-DOTA-ECL1i that recognizes CCR2 and propose to image CCR2 in the lung to ultimately guide diagnosis and therapy.
15920663|NCT03492749|Diagnostic Test|Saliva monitoring|The first objective of this project is to verify the feasibility of using the analysis of salivary concentration of BU during individual adjustments of this drug in the period that precedes HSCT
15920664|NCT03492736|Dietary Supplement|Melatonin|30 days 10mg Melatonin taken nightly 1 hour before bed
15920665|NCT03492736|Other|Placebo|30 days placebo taken nightly 1 hour before bed
15920666|NCT03492723|Dietary Supplement|Aged Garlic Extract|NR
15920667|NCT03492710|Biological|Immunoglobulin|Administer volume of IGIV-SN to maintain a trough level of of 5g/L or more
15920668|NCT03492697|Drug|PF-06882961 Immediate Release Tablet|Immediate Release Tablet
15920669|NCT03492697|Drug|PF-06882961 Controlled Release Tablet (long)|Controlled Release tablet (long)
15920670|NCT03492697|Drug|PF-06882961 Controlled Release Tablet (short)|Controlled Release tablet (short)
15920671|NCT03492697|Drug|PF-06882961 Immediate Release Solution|PF-06882961 Immediate Release solution
15920672|NCT03492684|Procedure|total hip arthroplasty|total hip arthroplasty and EMG
15920673|NCT03492671|Drug|Gemcitabine 1000 mg|Pre-Operative: 1000 mg/m2 IV on days 1, 8, 15 (28 days cycles times 4 cycles) Post-Operative: 1000 mg/m2 IV on days 1, 8, 15 (28 days cycles times 2 cycles)
15920674|NCT03492671|Drug|nab-paclitaxel|Pre-Operative: 125 mg/m2 IV on days 1, 8, 15 (28 days cycles times 4 cycles) Post-Operative: 125 mg/m2 IV on days 1, 8, 15 (28 days cycles times 2 cycles)
15920675|NCT03492671|Radiation|Stereotactic Body Radiation Therapy|Standard Stereotactic Body Radiation Therapy (SBRT) fractionation of 6 Gy per day will be used for all patients to a total dose of 30 Gy.
15920676|NCT03492658|Drug|Abatacept|Patients will be randomized to treatment with either methotrexate monotherapy (10 - 25 mg once weekly) or a combination therapy of methotrexate (10 - 25 mg once weekly) and abatacept (125 mg subcutaneously once weekly) for 6 months, followed by methotrexate monotherapy (10 - 25 mg once weekly) in both groups for another 6 months.
15920677|NCT03492658|Drug|Methotrexate|Patients will be randomized to treatment with either methotrexate monotherapy (10 - 25 mg once weekly) or a combination therapy of methotrexate (10 - 25 mg once weekly) and abatacept (125 mg subcutaneously once weekly) for 6 months, followed by methotrexate monotherapy (10 - 25 mg once weekly) in both groups for another 6 months.
15920678|NCT03492645|Behavioral|Telephone-and technology-facilitated treatment protocol|"8 video or telephone counseling sessions targeting PTSD symptoms related to smoking lapse. The first of these sessions will last approximately 45-60 minutes, and the remaining 7 sessions will last 20-30 minutes.
~Use of the Stay Quit Coach (SQC) app between sessions. SQC is a public domain, no-cost mobile app designed by our co-investigators at the National Center for PTSD to complement the IC protocol with evidence-based tools to support smoking cessation, such as motivational messaging and coping tools for managing PTSD symptoms associated with smoking lapse.
~Use of the Covita Bedfont iCO Smokerlyzer, a mobile carbon monoxide (CO) monitor, compatible with iOS and Android smartphones, that provides CO readings to the user at any time in order to self-monitor progress in quitting. The Covita iCO mobile app is used with the iCO Smoerlyzer to display CO readings."
15920679|NCT03492645|Behavioral|Office-based treatment protocol|Weekly face-to-face sessions using the unmodified treatment manual developed by McFall and Saxon, a protocol combining office-based therapy plus evidence-based pharmacotherapies for smoking cessation that doubled quit rates in veteran smokers with PTSD.
15920680|NCT03492632|Other|Hormone panel|Blood sampling on the 3rd day of menstrual cycle for the measurement of serum FSH,LH,PRL,E2 and AMH hormone levels.
15920681|NCT03492619|Behavioral|Intensive Intervention|an intervention focused on alleviating discouragement, food insecurity, and excess weight in women and targeted at the individual, family, and community levels
15920682|NCT03492619|Behavioral|Non-Intensive Intervention|Group sessions for healthy lifestyle
15920683|NCT03492606|Procedure|Samples|lumbar puncture, blood and CSF samples, SNPs analysis
15920684|NCT03492593|Other|lycopene|A tomato oleoresin containing lycopene
15920685|NCT03492593|Other|beta-carotene|13C beta-carotene
15920686|NCT03492593|Other|control|emulsified liquid meal alone
15920687|NCT03492580|Drug|Canagliflozin|No intervention or treatment assignment imposed by this study. Participants received canagliflozin as a part of routine clinical practice.
15920688|NCT03492580|Drug|Empagliflozin|No intervention or treatment assignment imposed by this study. Participants received empagliflozin as a part of routine clinical practice.
15920689|NCT03492580|Drug|Dapagliflozin|No intervention or treatment assignment imposed by this study. Participants received dapagliflozin as a part of routine clinical practice.
15920690|NCT03492580|Drug|Dipeptidyl Peptidase-4 (DPP-4) Inhibitors|No intervention or treatment assignment imposed by this study. Participants received DPP-4 inhibitor as a part of routine clinical practice. DPP-4 inhibitors includes: alogliptin, linagliptin, saxagliptin, sitagliptin, vildagliptin.
15920691|NCT03492580|Drug|Glucagon-like Peptide-1 (GLP-1) Agonist|No intervention or treatment assignment imposed by this study. Participants received GLP-1 agonist as a part of routine clinical practice. GLP-1 agonists includes: albiglutide, dulaglutide, exenatide, liraglutide, lixisenatide.
15920692|NCT03492580|Drug|Anti-hyperglycemic Agents (AHA)|No intervention or treatment assignment imposed by this study. Participants received other selected AHA as a part of routine clinical practice. Other select AHAs includes: acarbose, bromocriptine, miglitol, nateglinide, repaglinide.
15920693|NCT03492580|Drug|Thiazolidinediones (TZD)|No intervention or treatment assignment imposed by this study. Participants received TZD as a part of routine clinical practice. TZDs includes: pioglitazone, rosiglitazone, troglitazone.
15920694|NCT03492580|Drug|Sulfonylureas (SU)|No intervention or treatment assignment imposed by this study. Participants received SU as a part of routine clinical practice. SUs includes: glipizide, glyburide, glimepiride, chlorpropamide, tolazamide, tolbutamide, acetohexamide
15920695|NCT03492580|Drug|Insulin|No intervention or treatment assignment imposed by this study. Participants received Insulin as a part of routine clinical practice.
15920696|NCT03492567|Biological|Blood test|Blood draw (max 15 ml)
15920697|NCT03492554|Other|1-Lead ECG|All participants will record three single-lead ECGs
15920698|NCT03492554|Device|12-Lead ECG|All participants will simultaneously record three 12-lead ECGs
15920699|NCT03492541|Other|Propylene glycol-based eye drops|Nano-emulsion ocular lubricant
15920700|NCT03492528|Biological|blood samples|blood samples
15920701|NCT03492515|Drug|recombinant human thrombopoietin|If platelet count <30×10^9/L and with haemorrhage or risk of bleeding,the patients began to receive subcutaneous injection of TPO with the dose of 300 Unit/kg qd,duration ≤14 days;If platelet count is between 30×10^9/L and 50×10^9/L, the dose will be 300 Unit/kg qod;If platlet count ≥100×109/L, stop this treatment;After delivery, if platelet count <30×10^9/L and with haemorrhage or risk of bleeding,subcutaneous injection of TPO with the dose of 300 Unit/kg qd or qod will be given at a duration ≤14 days;If platelet count is between 30×10^9/L and 50×10^9/L, the dose will be 300 Unit/kg qw;If platlet count ≥100×109/L, stop the treatment.
15920702|NCT03492515|Drug|Platelet Concentrate|according to the their conditions, use if necessary
15920703|NCT03492502|Biological|Autologous Fecal Microbiota Transplantation|"Consenting allo- SCT patients with acute steroid-resistant GI-related GVHD grade III-IV will receive autologous FMT by nasogastric tube. Standardized stool suspension will be given once a day for two consecutive days.In order to prevent aspiration, patients will be kept in a 45ᵒ upright position for four hours. Participants will fast the night before and be treated with proton pump inhibitors prior to each FMT.
~In cases where complete response was not obtained within 7 days after autologous FMT, patients may be eligible for another trail of autologous FMT or to switch to other pharmacological interventions. Stool samples will be collected before and after the intervention for microbial analyses."
15920704|NCT03492489|Drug|cemiplimab|Intravenous (IV) administration
15920778|NCT03491969|Drug|Placebos|200 mg, po, tid
15920705|NCT03492476|Device|Circaid|"Three observation periods were defined with the following products:
~D1 to D5: intensive hospital treatment performed by the night and day wearing of the circaid® compression system
~Day of Discharge (DD) from the hospital to DD +30: ambulatory initial maintenance phase carried out by the wearing of a compression sleeve on the day associated with the nighttime compression system circaid®
~DD + 31 to DD + 90: ambulatory maintenance phase carried out by the wearing of a compression sleeve on the day associated with the nighttime circaid® compression system"
15920706|NCT03492476|Device|Short-stretching Bandage (Reference treatment)|"Three observation periods were defined with the following products:
~D1 to D5: intensive hospital treatment performed by the night and day wearing of short stretching tapes.
~DD (Day of discharge from the hospital) to DD +30: ambulatory initial maintenance phase carried out by the wearing of a compression sleeve on the day associated with a possible treatment at night, as recommended by HAS.
~DD + 31 to DD + 90: ambulatory maintenance phase carried out by the wearing of a compression sleeve on the day associated with possible treatment at night"
15920707|NCT03492463|Drug|Nicotine patch|Participants will wear the nicotine patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
15920708|NCT03492463|Other|Placebo patch|Participants will wear the placebo patch daily while switching from cigarette use to use of e-cigarettes for eight weeks.
15920709|NCT03492463|Other|E-cigarettes|Participants will use e-cigarettes containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
15920710|NCT03492463|Other|Non-nicotine e-cigarettes|Participants will use e-cigarettes not containing nicotine while switching from cigarette use to use of e-cigarettes for eight weeks.
15920711|NCT03492450|Other|Treadmill training|Tailored treatment comprising of: 1) aerobic exercises with the aim of increasing fitness 2) task-oriented balance exercises on the treadmill to improve balance and 3) cognitive behavioral interventions to improve balance and gait during dual task activities.In accordance with the literature (Langeskov-Christensen, 2015, Latimer-Cheung, 2013) the treadmill training will be carried out without body weight support, but the participants will be allowed to use the handrails for balance support if needed. The training consists of three different walking sessions, each lasting for 10 minutes: 1) preferred walking speed at an increased slope; 2) walking doing dynamic balance exercises (for example walking with feet in tandem) 3) fast gait speed defined as a 10% increase in walking speed relative to preferred speed with dual task exercises. During the 8-week intervention, walking speed in session 3 will be gradually increased with 10% to 40% of preferred speed.
15920712|NCT03492437|Drug|Dabigatran Etexilate|Participants will receive single oral dose of Dabigatran etexilate on Day 1 of Treatment period 1 and co-administration of Dabigatran with Tepotinib on Day 8 of Treatment period 2.
15920713|NCT03492437|Drug|Tepotinib|Participants will receive single oral dose of Tepotinib for 8 days in Treatment period 2.
15920714|NCT03492424|Device|cryotherapy|Subjects will receive focal cryotherapy for treatment of prostate cancer
15920715|NCT03492411|Other|eHealth Breastfeeding Co-parenting Resource|The eHealth breastfeeding co-parenting resource was designed using a participatory model in partnership with the target population. It contains extensive information about breastfeeding and co-parenting. The topics include not only the importance of breastfeeding and technique but also information on how to manage common issues during breastfeeding establishment as well as over the child's first years, since breastfeeding is recommended to two years and beyond. Interactive learning elements, videos, and links to additional resources are included in the resources.
15920716|NCT03492398|Drug|HY209|6 subjects will be assigned to drug (HY209) and 2 subjects will be assigned to placebo.
15920717|NCT03492385|Drug|PB2452 Infusion|30 minute - 12 hour infusion
15920718|NCT03492385|Drug|Placebo - Sodium Chloride|30 minute - 12 hour infusion
15920719|NCT03492385|Drug|Ticagrelor Oral Tablet - Pre-Treatment|Ticagrelor 180 mg + 90 mg BID for 5 doses prior to MEDI2452 (PB2452) or Placebo
15920720|NCT03492385|Drug|Ticagrelor Oral Tablet - Pre-Treatment and Post-Treatment|Ticagrelor 180 mg + 90 mg BID for 5 doses prior to MEDI2452 (PB2452) or Placebo and Ticagerlor 180 mg 24 hours following MEDI2452 (PB2452) or Placebo
15920721|NCT03492372|Other|Waste tissues are collected at the time of spinal surgery.|This is a single visit study. Waste tissues are collected at the time of spinal surgery.
15920722|NCT03492359|Device|Thora-3Di|Device that uses a grid of structured light to measure chest and abdominal wall movement
15920723|NCT03492359|Device|Body Plethysmography|A pulmonary function test (PFT) for measuring total lung volume.
15920724|NCT03492359|Device|Spirometry|A pulmonary function tests (PFT) for measuring maximal forced expiratory flow and volume.
15920725|NCT03492333|Other|Gluten free diet|Gluten-free diet- Instructions provided by a dietitian
15920726|NCT03492320|Other|Health Quality of Life Questionnaire Assessment|Western Ontario and McMaster University Osteoarthritis Index (WOMAC), Self-Rated Questionnaire SF36 and Health Related Quality of Life (HRQoL) 15D questionnaire were used as outcome measurement for functionality and disability assessment.
15920727|NCT03492307|Other|Weight-Based Flow for High Flow Nasal Cannula (HFNC) (2L/kg/minute)|A weight-based flow for HFNC.
15920728|NCT03492307|Other|Standard Flow for HFNC (Maximum 8L/minute)|Maximum flow of 8L/minute.
15920729|NCT03492294|Diagnostic Test|functional magnetic resonance imaging|Patients with disorders of consciousness were assessed by functional magnetic resonance imaging while they were exposed under the condition of music.
15920730|NCT03492281|Drug|vibegron|single daily oral dose of vibegron 75 mg for 12 weeks
15920731|NCT03492281|Drug|Vibegron placebo|placebo to match vibegron (experimental drug)
15920732|NCT03492281|Drug|Tolterodine Tartrate ER|single daily oral dose of tolterodine tartrate ER 4 mg for 12 weeks
15920733|NCT03492281|Drug|Tolterodine placebo|placebo to match tolterodine (active comparator)
15920734|NCT03492268|Biological|BCMA-CART|After a conditioning therapy, each patient will receive a treatment of BCMA-CART originated from their own peripheral blood mononuclear cells
15920735|NCT03492255|Drug|Cyclophosphamide|Patients in both EUROLUPUS group and CYCLONES Group will receive for 3 months Cyclophosphamide (6 doses of 500mg/biweekly)
15920736|NCT03492255|Drug|Methylprednisolone|"Patients in EUROLUPUS group will receive Methylprednisolone [750 mg for three consecutive days).
~Patients in CYCLONES Group will receive Methylprednisolone [500 mg (day 0 and day 15), 250 mg (day 30 and day 45) and 125 mg (day 60 and day 75)."
15948970|NCT03272386|Other|Observational study|Completing a questionnaire
15920737|NCT03492255|Drug|Prednisone|Patients in EUROLUPUS group will receive oral prednisone ≤ 30 mg/day with a reduction of 5mg/month until complete withdrawal.
15920738|NCT03492255|Drug|Mycophenolate Mofetil|From the third month of protocol, patients in both EUROLUPUS group and CYCLONES Group will receive mycophenolate mofetil (2-3 g/day) until the sixth month of study.
15920739|NCT03492242|Drug|Immune checkpoint inhibitor|Immune checkpoint inhibitor targeting either PD-1, PD-L1 or CTLA-4, and included in the following list (ATC classification) as a monotherapy or in combination: Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32).
15920740|NCT03492229|Other|tDCS|1 mA of tDCS
15920741|NCT03492229|Other|AMT|Ankle motor training
15920742|NCT03492229|Behavioral|Treadmill training|High intensity treadmill training
15920743|NCT03492216|Behavioral|Incentives for negative EtG test|Economic incentives are given to the study participant contingent on point-of-care (POC) urine ethyl glucuronide (EtG) <300 ng/mL with the amount of the incentive escalating with each subsequent negative EtG test.
15920744|NCT03492216|Behavioral|Incentives for positive IsoScreen test|Economic incentives contingent on POC (IsoScreen) INH urine positive tests with the amount of the incentive escalating with each subsequent positive IsoScreen test.
15920745|NCT03492203|Behavioral|Active Cognitive Remediation|Cognitive remediation engages participants in computerized exercises meant to improve cognitive functions and provides therapist feedback for how these improvements manifest in everyday life. The novel components of CR in this study will be the delivery of treatment remotely.
15920746|NCT03492203|Behavioral|Cognitive Remediation Control|The investigators have developed a 'comparison' cognitive remediation treatment in collaboration with the same company that produced the cognitive exercises. These procedures include the same stimuli but are adjusted without increasing cognitive load.
15920747|NCT03492203|Behavioral|Online computer exercises|There are 30 unique cognitive exercises in the program (sbtpro.com). The investigators will prescribe 24 exercises in the domains most commonly impaired in MDD: six targeting executive functions, ten targeting memory, and eight targeting attention and working memory. The specific activities are prescribed in a fixed, systematic order, such that the participants have a schedule of exercises that address several different cognitive domains each week and return to exercises in subsequent weeks. Parameters are automatically adjusted based on participant performance across 30 difficulty levels. Participants are prescribed two 20-minute sessions per day, five days per week, for the duration of the study.
15920748|NCT03492203|Behavioral|Strategy monitoring|Therapists communicate with participants in asynchronous private and group forums, where specific responses to questions prime flexible strategy formation, monitoring of strategies, and bridging to real world functioning. Participants use logs to track their own strategies and upload this information to the forum for therapist feedback. The purpose of the therapist responses is to reinforce the development of multiple strategies and help supplement or reshape those that are concrete, based on a predetermined list of strategies developed for each of the computer exercises.
15920749|NCT03492203|Behavioral|Bridging strategies|The online forum will have illustrations for bridging cognitive abilities and problem solving strategies related to each game to experiences in the real world. An at home workbook will also be used to facilitate active application of skills in various domains (e.g., work, socialization, recreation, household maintenance).
15920752|NCT03492138|Drug|ONC201|625mg
15920753|NCT03492138|Drug|Ixazomib|Dose to be determined in Phase 1 of study
15920754|NCT03492138|Drug|Dexamethasone|40mg
15920755|NCT03492125|Drug|MS-533|MS-553
15920756|NCT03492112|Device|HCV RNA Point of Care|Participants attending needle syringe programmes in Australia will be screened for hepatitis C using the finger-stick whole blood GeneXpert HCV RNA cartridge.
15920757|NCT03492112|Drug|Sofosbuvir/velpatasvir|Participants with a detectable HCV RNA will be offered treatment with either glecaprevir/pibrentasvir or sofosbuvir/velpatasvir.
15920758|NCT03492112|Drug|Glecaprevir/pibrentasvir|Participants with a detectable HCV RNA will be offered treatment with either glecaprevir/pibrentasvir or sofosbuvir/velpatasvir.
15920759|NCT03492099|Drug|buprenorphine|Patients in this study will receive dosages to be determined by a physician that are specific to each patient.
15920760|NCT03492086|Dietary Supplement|Dietary supplementation with capsules containing rosemary and alkylglycerol|
15920761|NCT03492086|Dietary Supplement|Dietary supplementation with control capsules|
15920762|NCT03492073|Behavioral|Emotional Supportive Mindfulness-based Program|Mindfulness training
15920763|NCT03492073|Behavioral|Emotional Supportive Program|Narrative-orientated therapy.
15920764|NCT03492047|Dietary Supplement|low dose N-acetylcysteine|N-acetylcysteine 600mg twice daily
15920765|NCT03492047|Dietary Supplement|high dose N-acetylcysteine|N-acetylcysteine 1200mg twice daily
15920766|NCT03492047|Drug|Paclitaxel|Paclitaxel 80mg /m2 IV
15920767|NCT03492034|Device|IUD during CS|IUD insertion during CS
15920768|NCT03492034|Device|IUD after puerperium|IUD after puerperium
15920769|NCT03492021|Other|Diet Intervention_AP-CPT|Adequate Protein_Carbohydrate Post Therapy (AP-CPT) where protein intake will be 1 g/kg/d for the duration of the study .
15920770|NCT03492021|Other|Diet Intervention_PP-PPT|Optimal Protein_Protein Post Therapy (OP-PPT) with protein intake set at 2.0 g/kg/day for the duration of the study
15920771|NCT03492008|Other|Conventional technique|Nasogastric tube insertion with patient's head in neutral position
15920772|NCT03492008|Other|Contralateral cricothyroid pressure|Cricothyroid pressure is applied externally in the contralateral direction of selected nostril before nasogastric insertion.
15920773|NCT03492008|Other|Ipsilateral head turning|Patient's head is turned to the ipsilateral side of the selected nostril before nasogastric tube insertion.
15920774|NCT03491995|Drug|Quadruple therapy|Moxifloxacin, omeprazole sodium bicarbonate, nitazoxanide, doxycyclin
15920775|NCT03491995|Drug|Classic treatment|Omeprazole, amoxycillin, clarithromycin
15920779|NCT03491956|Device|DFPP|Lipid levels,platelet function，and platelet RNA sequencing in hyperlipidemia patients before and after DFPP
15920780|NCT03491943|Procedure|ultrasound-assisted midline approach|A preprocedural ultrasound scanning will be done, and skin marking will be made. The needle entry point and insertion angle will be determined based on ultrasound scanning. Spinal anesthesia will be performed via midline approach.
15920781|NCT03491943|Procedure|ultrasound-assisted paramedian approach|A preprocedural ultrasound scanning will be done, and skin marking will be made. The needle entry point and insertion angle will be determined based on ultrasound scanning. Spinal anesthesia will be performed via paramedian approach.
15920782|NCT03491930|Device|VA MOVE! Coach app|The VA MOVE! Coach app promotes weight loss through positive feedback, nutritional education, calorie counts, graphs, charts, and encourages increased activity. Efforts will be supported through weekly phone coaching.
15920783|NCT03491930|Behavioral|Telephone Coaching|Weekly Telephone Coaching
15920784|NCT03491930|Behavioral|Standard of Care for weight loss.|"Standard of Care for weight loss (2013 American College of Cardiology/American Heart Association Task Force and The Obesity Society (AHA/ACC/TOS) Report,PubMed Identification: 24222017).
~To include:
~Vioscreen food frequency assessment and bionutritionist consult.
~Healthy eating nutritional pamphlets (during consult)
~Decrease daily caloric intake by 500 cal/day
~Increase in physical activity (goal: 10,000 steps per day - measured by pedometer.)
~Dietary counseling by Clinician (monthly)"
15920785|NCT03491917|Device|DBT plus S-View|DBT plus S-View images
15920786|NCT03491917|Device|FFDM alone|FFDM alone images
15920787|NCT03491904|Drug|Fasinumab AI|Self-administered with auto injector
15920788|NCT03491904|Drug|Fasinumab PFS|Prefilled syringe administered by study staff
15920789|NCT03491878|Procedure|Three dimensional laparoscopic|Three dimensional laparoscopic cholecystectomy including segments IVB and V
15920790|NCT03491878|Procedure|Open|Open cholecystectomy including segments IVB and V
15920791|NCT03491865|Behavioral|REAL media Plus curriculum|REAL media Plus is a 7-level, interactive, self-paced, e-learning media literacy curriculum to prevent youth smoking and vaping use.
15920792|NCT03491852|Behavioral|BOOST Intervention|A cognitive and behavioural group therapy designed to reduce self-stigma and promote effective communication skills for adults (16-65 years old) experiencing a first episode of psychosis.
15920793|NCT03491852|Behavioral|Waitlist Control|Participants on the waitlist will still receive treatment as usual, which includes medical, psychosocial, and occupational interventions to help maximize patients' integration within the community and support recovery from a first episode of psychosis.
15920794|NCT03491826|Biological|rupture of membrane|
15920795|NCT03491813|Device|oscillometric device|"The blood pressure will be measured by the Automatic blood pressure monitor(Oscillometric) named the OMRON M2 basic® device was provided by Omron Healthcare company.
~This monitor uses inflation by Fuzzy-Logic controlled by electric pump and an automatic rapid pressure release valve for the deflation , its cuff allows BP measurements in arm circumference of 22-42 cm. The device measure BP and pulse rate with a pressure range of 0-299 mmHg and pulse rate range of 40-180 beats/min."
15920796|NCT03491800|Behavioral|Question/Topic Prompt List|A written document containing suggested questions that the family member and/or patient may want to ask the health care provider during the visit. A section is included for the patient to check which behaviors they would like for their family member to engage in during the visit and space is provided for the family member to check which behaviors they are willing to perform during the visit.
15920797|NCT03491787|Device|Ultrasound guidance|The ultrasound guidance was used to obtain intraosseous access
15920798|NCT03491774|Behavioral|Montessori Intervention|The Montessori method is a system of teaching developed by Maria Montessori based on principles to promote learning and independence in children. In the context of dementia care, this method has been tried in research settings in older people and was found to be effective in improving certain behavioral outcomes such as eating behaviors, agitation, and mood. The intervention is based on designing and offering activities that take into consideration the interests, needs, past experiences and preferences of participants. Importantly, participants demonstrating positive engagement with the intervention, suggesting that this may be a promising form of support to investigate and develop further for the care of people with dementia.
15920799|NCT03491761|Biological|PRP Treatment|PRP will be prepared using an Arthrex ACP® kit (a low-leukocyte Autologous Conditioned Plasma system). This is a single-spin system that concentrates platelets and separates red blood cells (RBCs) as well as white blood cells (WBCs) from the treatment product.
15920800|NCT03491761|Biological|HA Treatment|Euflexxa will be used for treatment. It will be prepared according to the package insert.
15920801|NCT03491748|Drug|ETX0282|Oral Gelatin capsules
15920802|NCT03491748|Drug|Cefpodoxime proxetil|Oral tablets
15920803|NCT03491748|Drug|Placebo|Oral Gelatin capsules
15920804|NCT03491735|Other|collection of data from patient files|recording of patient data and its input into an excel sheet from which statistics will be derived
15920805|NCT03491722|Other|risk factors and revascularization procedures|arterial revascularizations needed since index procedure
15920806|NCT03491709|Drug|anti-EGFR monoclonal antibody|Recombinant anti-EGFR human mouse chimeric monoclonal antibody injection
15920807|NCT03491709|Drug|Cetuximab injection|Cetuximab injection
15920808|NCT03491696|Drug|Metyrapone|Association of Selective Serotonin Reuptake Inhibitor or Serotonin and Norepinephrine Reuptake Inhibitor and METYRAPONE. Duration of the association : 28 days.
15920809|NCT03491683|Biological|INO-5401|INO-5401 is a combination of 3 separate DNA plasmids targeting Wilms tumor gene-1 (WT1) antigen, prostate-specific membrane antigen (PSMA) and human telomerase reverse transcriptase (hTERT) genes. Starting on Day 0 three milligrams (mg) of each plasmid will be delivered IM followed by EP using the CELLECTRA® 2000 EP device every three weeks for four doses, and then every 9 weeks until disease progression as defined by immunotherapy Response Assessment in Neuro-Oncology (iRANO), unacceptable toxicity, withdrawal of consent, or death.
15920810|NCT03491683|Biological|INO-9012|INO-9012 is a DNA plasmid for expression of human interleukin-12 (IL-12). Starting on Day 0 one mg plasmid will be delivered IM followed by EP using the CELLECTRA® 2000 EP device every three weeks for four doses, and then every 9 weeks until disease progression as defined by iRANO, unacceptable toxicity, withdrawal of consent, or death.
15920949|NCT03490786|Drug|GT-001|PK, PD Study to Determine Safety of Escalating Doses of GT-001
15920811|NCT03491683|Biological|Cemiplimab|Cemiplimab is an antibody to programmed death-1 (PD-1) protein. Starting on Day 0 cemiplimab will be administered intravenously (IV) every three weeks at a dose of 350 mg per dose in the absence of dose holding, until disease progression as defined by iRANO, unacceptable toxicity, withdrawal of consent, or death.
15920812|NCT03491683|Radiation|Radiation Therapy|Radiation therapy (RT) will begin no later than 42 days after surgical intervention, and should start approximately 2 weeks after Day 0. RT will be given for three weeks.
15920813|NCT03491683|Drug|Temozolomide|Temozolomide (TMZ) will be given daily during radiation therapy (RT) at a dose of 75 milligrams per square meter (mg/m^2).
15920814|NCT03491657|Behavioral|virtual reality distraction (Yes VR)|
15920815|NCT03491657|Behavioral|music distraction (No VR)|
15920816|NCT03491644|Drug|Titrated Oxygen|Restrictive treatment with oxygen.
15920817|NCT03491644|Drug|Liberal Oxygen|Liberal treatment with oxygen.
15920818|NCT03491631|Drug|SHR9146+SHR-1210|SHR9146: Initial dose of 100mg BID with escalation planned to 600mg BID; SHR-1210: 200mg Q2W
15920819|NCT03491631|Drug|SHR9146+SHR-1210+Apatinib|SHR9146: Initial dose of 100mg BID with escalation planned to 600mg BID; SHR-1210: 200mg Q2W Apatinib:250mg QD
15920820|NCT03491618|Other|PAIN REDUCTION ON VAS/NRS|Pain reduction comparing two different techniques and canulae placement, under fluoroscopic guidance.
15920821|NCT03491605|Other|peripheral EBV-DNA load|No intervention
15920822|NCT03491592|Behavioral|Enhanced Physical Activity Intervention|Participants in the Enhanced Intervention arm will receive all the intervention components of the Original Intervention described above plus: 1) text messages and adaptive goal-setting to drive participants back to the website and keep them there longer, and 2) data-driven, technology supported enhanced intervention content targeting theoretical constructs that influenced PA behavior in Latinas from the parent study.
15920823|NCT03491592|Behavioral|Original Physical Activity Intervention|Participants in the Original Physical Activity intervention arm of the study will receive the original Spanish language, motivationally-tailored, Internet-based physical activity intervention that specifically addresses the Physical Activity barriers and intervention needs/preferences of Latinas.
15920824|NCT03491579|Drug|Epacadostat|Epacadostat orally two times daily (BID) for two cycles (28 days each) in combination with standard induction chemotherapy (Cladribine and Cytarabine)
15920825|NCT03491579|Drug|Cladribine|Standard chemotherapy
15920826|NCT03491579|Drug|Cytarabine|Standard chemotherapy
15920827|NCT03491566|Other|Clinic Pilates Group|"Clinical Pilates exercises include Hundreds, One Leg Stretch, Shoulder Bridge, One Leg Kick, Swimming , Double Leg Stretch, Swan Dive Circle , Arm Opening , Spine Twist , Roll Down exercises."
15920828|NCT03491566|Other|Aerobic Exercise Group|Aerobic exercise with using an elliptical bike, or bike or treadmill under supervision of a physiotherapist.
15920829|NCT03491553|Drug|Selgantolimod|Tablet(s) administered orally once weekly
15920830|NCT03491553|Drug|Placebo|Placebo to match (PTM) selgantolimod tablet(s) administered orally once weekly
15920831|NCT03491553|Drug|Hepatitis B virus (HBV) OAV Therapy|"Commercially available HBV OAV therapy could include one of the following:
~Tenofovir disoproxil fumarate (TDF; Viread®) Entecavir (Baraclude®) Adefovir (Hepsera®) Lamivudine (Epivir® ) Telbivudine (Tyzeka®) Tenofovir alafenamide (TAF; Vemlidy®)"
15920832|NCT03491540|Drug|Sennosides colonic preparation|"Mechanical bowel preparation :
~Sennosides colonic preparation (X-PREP)
~1 per day, on day -2 and day -1"
15920833|NCT03491540|Drug|Oral Gentamycin|"Oral gentamycin:
~Gentamycin 80 mg, 4 per day, on day -2 and day -1; Liquid forms in individual vials"
15920834|NCT03491540|Drug|Oral Ornidazole|"Oral ornidazole :
~Ornidazole
~1 g per day (2 tablet per day), on day -2 and day -1; In tablets"
15920835|NCT03491540|Drug|Oral Placebo Gentamycin|"Placebo for oral gentamycin :
~Same presentation as oral gentamycin x4 per day on day -2 and day -1"
15920836|NCT03491540|Drug|Oral Placebo Ornidazole|"Placebo for oral ornidazole :
~Same presentation as oral ornidazole
~1g per day (2 tablets per day) on day -2 and day -1"
15920837|NCT03491527|Procedure|Absolute isolation|Absolute isolation with rubber dam
15920838|NCT03491527|Procedure|Manipulation of the resin cement with MTA|Manipulation of the resin cement with MTA according to the manufacturer's recommendations.
15920839|NCT03491527|Procedure|Manipulation of the resin cement without MTA|Manipulation of the resin cement without MTA according to the manufacturer's recommendations.
15920840|NCT03491527|Procedure|Fiber Post cimentation|Insertion of the cement on the root canal and on post surface. Light-cured for 40 seconds on each surface.
15920841|NCT03491527|Procedure|Dental Prepare|Confection of a indirect crown prepare with diamand burs.
15920842|NCT03491527|Procedure|Dental impression|Dental impression whith silicone.
15920843|NCT03491527|Procedure|Crown cimentation|Insertion of the cement on the inner surface of the crown. Light-cured for 40 seconds on each surface.
15920844|NCT03491527|Procedure|Occlusal adjustment|Analysis of the occlusion with carbon paper.
15920845|NCT03491514|Other|Test Granola|51 g Test Granola
15920846|NCT03491514|Other|Control Granola|54.1 Control Granola
15920847|NCT03491501|Other|Ergonomic evaluation using questionnaires|Employees will be provided with questionnaires such as the 'Rapid Entire Body Assessment' and NIOSH to obtain information regarding ergonomic working situations
15920848|NCT03491488|Other|Brain Games|The Brain Games intervention package is used as a tool to improve children's self-regulation and executive function skills. Brain Games were developed as part of larger behavioral intervention package in the US, and are designed to build the fundamental self-regulation skills that children need to be successful in school as well as later in life. The games are designed to be played in the classroom between regular activities.
15920849|NCT03491475|Drug|Ajmaline test|Administration of Ajmaline
15920850|NCT03491462|Drug|Arimoclomol|Active treatment
15920851|NCT03491462|Drug|Placebo oral capsule|Matching placebo capsule
15920852|NCT03491449|Procedure|Group A|Maintaining a systolic blood pressure ≥ 140 and ≤ 160mm Hg for 72 hours.
15920853|NCT03491449|Procedure|Group B|Maintaining a systolic blood pressure <185mm Hg for 72 hours.
15920854|NCT03491436|Device|iHealth Align|remote monitor glucometer
15920950|NCT03490760|Drug|Durvalumab|Durvalumab 1500 mg (or 20 mg/m2 if <30 kg) IV every 4 weeks
15921235|NCT03488251|Drug|MT-3724|Experimental treatment with MT-3724 in combination with GEMOX therapy.
15920855|NCT03491423|Other|Short and fast step test without measurement of pulmonary gas exchange|For one minute, the patient should climb up and down a 17.5 cm high step as quickly as possible while holding onto a bar in front of the step.
15920856|NCT03491423|Biological|glucose meter|glucose meter to measure lactatemia
15920857|NCT03491423|Other|ECG / heart rate|ECG and heart rate (HR) collection by telemetry
15920858|NCT03491423|Other|questionnaires|VAS pain assessment and evaluation of effort perception according to Borg's scale
15920859|NCT03491423|Other|Short and fast step test with measurement of pulmonary gas exchange|For one minute, the patient should climb up and down a 17.5 cm high step as quickly as possible while holding onto a bar in front of the step.
15920860|NCT03491410|Drug|Aspirin Low Dose|Low-Dose Aspirin is to be added in the standard patient´s treatment
15920861|NCT03491410|Drug|Placebo Oral Tablet|Placebo is to be added in the standard patient´s treatment
15920862|NCT03491397|Device|Embozene MicroSpheres|Embozene is a medical device made by Boston Scientific approved in the United States for the treatment of hypervascular tumors and arteriovenous malformations. It consists of thousands of microscopic spheres that are injected into the artery in the knee going to the region of pain. One of the causes of pain in the setting of knee arthritis is increased blood flow going to the specific area of pain. The goal of this procedure is to decrease the blood flow (embolize) to the specific region of the knee that is causing your pain. This is done by infusing Embozene particles into the specific blood vessel (genicular artery) supplying the area of pain in the knee.
15920863|NCT03491384|Drug|Cannabis (smoked flower, ingested edible)|Self-Directed Use (ad-libitum)
15920864|NCT03491371|Drug|Methylsulfonic apatinib|Anti-angiogenesis Tyrosine kinase inhibitor which specifically inhibits VEGFR-2.
15920865|NCT03491358|Device|Wright jet nebulizer|Roxon Medi-Tech, Montreal, QC, Canada
15920866|NCT03491358|Device|Aerogen Solo|Aerogen Ltd., Galway, Ireland
15920867|NCT03491345|Drug|Avelumab|avelumab 10mg/kg, IV, q 2 weeks
15920868|NCT03491332|Device|conventional circuit|"The patient enters the operating room without any pretreatment and attaches a standard patient monitoring device. Anesthesia was performed by intravenous anesthesia. After induction of anesthesia, alveolar recruitment is performed in supine position in all groups with 30 cmH2O for 5 seconds. Mechanical ventilator was set with tidal volume of 8 ml / kg, the inspiratory/ expiratory ratio of 1: 2 and respiratory rate was adjusted for targeting EtCO2 around 35mmHg. Keep the fresh air flow of the ventilator at 3 L / min and set the temperature to 37 ° C for the heating circuits of group H and group SH. An arterial cannulation and subclavian jugular vein catheter is inserted.
~The circuits were applied to each group as follows; conventional circuit or group C, conventional humidification circuit for group H and new humidification heat circuit for group SH, respectively. All other conditions were same among three groups."
15920869|NCT03491332|Device|conventional humidification circuit|"The patient enters the operating room without any pretreatment and attaches a standard patient monitoring device. Anesthesia was performed by intravenous anesthesia. After induction of anesthesia, alveolar recruitment is performed in supine position in all groups with 30 cmH2O for 5 seconds. Mechanical ventilator was set with tidal volume of 8 ml / kg, the inspiratory/ expiratory ratio of 1: 2 and respiratory rate was adjusted for targeting EtCO2 around 35mmHg. Keep the fresh air flow of the ventilator at 3 L / min and set the temperature to 37 ° C for the heating circuits of group H and group SH. An arterial cannulation and subclavian jugular vein catheter is inserted.
~The circuits were applied to each group as follows; conventional circuit or group C, conventional humidification circuit for group H and new humidification heat circuit for group SH, respectively. All other conditions were same among three groups."
15920870|NCT03491332|Device|new humidifaction heat circuit|"The patient enters the operating room without any pretreatment and attaches a standard patient monitoring device. Anesthesia was performed by intravenous anesthesia. After induction of anesthesia, alveolar recruitment is performed in supine position in all groups with 30 cmH2O for 5 seconds. Mechanical ventilator was set with tidal volume of 8 ml / kg, the inspiratory/ expiratory ratio of 1: 2 and respiratory rate was adjusted for targeting EtCO2 around 35mmHg. Keep the fresh air flow of the ventilator at 3 L / min and set the temperature to 37 ° C for the heating circuits of group H and group SH. An arterial cannulation and subclavian jugular vein catheter is inserted.
~The circuits were applied to each group as follows; conventional circuit or group C, conventional humidification circuit for group H and new humidification heat circuit for group SH, respectively. All other conditions were same among three groups."
15920871|NCT03491319|Procedure|Group X - head low tilt|spinal anaesthesia was given with table in neutral positon. 10 degree head low position was maintained for 10 minutes following spinal anaesthesia
15920872|NCT03491319|Procedure|Group Y - head low tilt|the table was put in 10 degree head low position before proceeding to give spinal anaesthesia. Head low position was maintained for 10 minutes following spinal
15920873|NCT03491319|Procedure|Group C - neutral|spinal anaesthesia was given with table in neutral positon. Patient was maintained in supine position for 10 minutes following spinal anaesthesia
15920874|NCT03491306|Other|PEEK|PEEK has been successfully used over the last years in the medical ﬁeld, and orthopedics, speciﬁcally. which presents high bio compatibility, good mechanical properties, high temperature resistance, and chemical stability due to a 4 GPa modulus of elasticity, it is as elastic as bone and can reduce stresses transferred to the abutment teeth.Additional advantages of this polymer material are elimination of allergic reactions and metallic taste, high polishing qualities, low plaque afﬁnity, and good wear resistance, it has only recently been used in dentistry.
15920875|NCT03491306|Other|Breflex|"In the recent time thermoplastic materials become quite popular in clinical practice such as nylon and acetal resins. since the 1950, poly-amide resin (nylons) provide improved esthetics and reduction of rotational forces on the abutment teeth due to their low elastic modulus(3).
~The major disadvantage of a nylon removable denture is the inability for a reline procedure and the lack of occlusal rests as well as rigid frameworks, that could lead to occlusal instability and sinking, especially in Kennedy class I and II cases. On the other hand, acetal resins present adequate mechanical strength to form a frame-work more rigid than nylon with retentive clasps, connectors, and supportive elements; however, the acetal resin material lacks natural translucency and vitality."
15920951|NCT03490760|Radiation|Radiation Therapy|24 Gy in 3 daily fractions to one lesion during Week 3 and 24 Gy in 3 daily fractions to the second lesion during Week 5.
15921191|NCT03488680|Behavioral|Behavior change communication|Behavior change communication about optimal complementary feeding
15920876|NCT03491293|Behavioral|Behavioral Weight Loss + Text|Participants will attend weekly one hour classes on line. They will type their input and responses within the chat room. They will record their calorie and fat intake daily and weigh themselves daily. Interventionists will review the diaries weekly and provide feedback to reinforce or shape new behaviors and to identify high risk situations for problem solving.
15920877|NCT03491293|Behavioral|Behavioral Weight Loss + Video|Participants will attend weekly one hour classes on line. They will have audio and video within the chat room, and will talk with their facilitator and classmates during their weekly meeting. They will record their calorie and fat intake daily and weigh themselves daily. Interventionists will review the diaries weekly and provide
15920878|NCT03491280|Genetic|NGS Diagnostic|Blood take for genetic diagnostic.
15920879|NCT03491267|Drug|Retinoic acid|The study team will treat skin with topical retinoic acid
15920880|NCT03491267|Device|Laser|The study team treat skin with a surface laser.
15920881|NCT03491267|Drug|Sham treatment|No drug will be given
15920882|NCT03491267|Device|Sham treatment|No laser treatment will be given
15920883|NCT03491241|Dietary Supplement|hypocaloric diet therapy|all patients will receive an hypocaloric diet, with low carboidrates (<50%) overload.
15920884|NCT03491215|Drug|Ruxolitinib|Ruxolitinib taken orally (5mg tablets) or oral pediatric formulation and dosage based on age group
15920885|NCT03491189|Device|Lag screw fixation|surgical fixation
15920886|NCT03491189|Device|Helical blade fixation|surgical fixation
15920891|NCT03491163|Diagnostic Test|Syndecan-1 concentration evaluation|Blood sample will be taken and analysed using ELISA method.
15920892|NCT03491150|Drug|Crenezumab|Crenezumab was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.
15920893|NCT03491124|Other|Auricular Acupuncture|Up to five small ASP needles placed in each ear until pain is reduced to 1/10.
15920894|NCT03491124|Other|Sham Treatment|Laser pointer pointed at the ear, but not turned on.
15920895|NCT03491111|Other|Respiratory muscle training for EMT+IMT|2 times per day and 5 day per week, 6 weeks, training with breathing trainer.
15920896|NCT03491111|Other|Regular Rehabilitation|Regular Rehabilitation: 2-3 times a week, 6 weeks.
15920897|NCT03491111|Other|Respiratory muscle training for EMT|5 sets, 5 repetition with one or two minute of rest between sets, twice per day, 5 days per week, training with breathing trainer.
15920898|NCT03491098|Drug|Mometasone Furoate spray|"Mometasone Furoate spray one puff in each nostril daily for 8 weeks
~hypertonic sea water solution spray one puff in each nostril daily for (8) weeks."
15920899|NCT03491098|Drug|prednisolone sodium phosphate 15mg|three times per day for 1 week then gradual withdrawal over 2 weeks
15920900|NCT03491098|Drug|hypertonic sea water solution spray|one puff in each nostril daily for 8 weeks
15920901|NCT03491085|Drug|Amoxicillin/clavulanate|after tonsillectomy half of our patients will receive Amoxicillin /clavulanate for one week and the other half will not receive it.
15920902|NCT03491072|Device|Transcutaneous electrical nerve stimulation|Patients will receive IV fentanyl 1µg /Kg with the application of conventional TENS in which constant mode will be chosen. Assessment of pain will be done using visual analogue scale (VAS), every 10 minutes. If VAS ≥ 3 this indicates giving IV increments of 20µg of fentanyl.
15920903|NCT03491072|Drug|Fentanyl|Patients will receive IV fentanyl
15920904|NCT03491059|Drug|C-11 labeled nicotine|Participants will vape with e-cigarettes radio-labeled with C-11 nicotine.
15920905|NCT03491059|Radiation|PET/CT imaging|After vaping with radio-labeled e-cigarettes, participants will be PET/CT imaged.
15920906|NCT03491046|Device|PET scan|low dose fluorodeoxyglucose (FDG) PET research scan with CEST sequence
15920907|NCT03491046|Device|MRI scan|standard of care MRI
15920908|NCT03491033|Drug|chemotherapy|All of the patients in this study underwent NAC regimens consisting of taxane and platinum combination chemotherapy. After NAC, all of the patients underwent interval debulking surgery. Subsequently, additional cycles of chemotherapy were administered after IDS to complete a total of 6 cycles at the discretion of the treating physician.
15920909|NCT03491007|Drug|DHEA|Subjects will be randomized to receive a one-time oral dose of DHEA (400mg) or PBO and sustained administration of the study drug for 6 weeks. There will be a 2 week placebo lead-in period [all participants], followed by subjects continuing in the randomization block of DHEA or placebo for 6 weeks following acute administration).
15920910|NCT03490994|Drug|Rivaroxaban|Rivaroxaban 20mg qd (15mg qd when CrCl 30-49 ml/min using creatinine-based CKD-EPI equations) for 6 months
15920911|NCT03490994|Drug|Warfarin + LMWH|dose-adjusted warfarin (target INR 2-3) for 6 months + LMWH (enoxaparin 1 mg/kg q12h for a few days until INR target achieved) if indicated
15920912|NCT03490981|Other|Treatment as usual (TAU)|Participants assigned to TAU will receive standard medical care from their primary care provider including pain medications, brief advice (e.g., use of relative rest, application of heat or ice, other self-care strategies), or referral to pain-related adjunctive interventions (e.g., physical therapy), as indicated.
15920913|NCT03490981|Behavioral|Brief Cognitive Behavioral Therapy for Chronic Pain (Brief CBT-CP)|Brief CBT-CP is a manualized protocol that includes six, 30-minute sessions over the course of 6 weeks. Brief CBT-CP session outlines and patient handouts are included in the appendix. Session one focuses on foundational pain education and the development of treatment goals. Session two emphasizes balanced engagement in physical activity and pleasurable events. Session three emphasizes skills training for easily implemented relaxation techniques. Sessions four and five focus on recognizing and modifying unhelpful thoughts that negatively impact pain. Session six focuses on relapse prevention and independent implementation of CBT-CP skills following treatment.
15920914|NCT03490968|Behavioral|Supervised Exercise|Subjects will have 3 visits per week for 12 weeks.
15920998|NCT03490344|Drug|Daratumumab|"Cycles 1 and 2: Daratumumab 16mg/kg weekly per cycle (28 days) as intravenous infusion (total duration: 8 weeks)
~Cycles 3-6: Daratumumab 16mg/kg once every 2 weeks per cycle (28 days) as intravenous infusion (total duration: 16 weeks)"
15949062|NCT03271723|Other|Observational study|No intervention
15920915|NCT03490968|Behavioral|Vascular Assessment|"Screen: Subjects will undergo a H&P, ankle brachial index, ECG, CBC, CMP, lipid panel, HgA1C, and urinalysis. A urine pregnancy test will be performed on women of childbearing age.
~Testing Visit 1: MRI, IV in common femoral vein with phlebotomy (60 cc total) before and after sphygmomanometric cuff occlusion of lower limb, 6-minute walk test, 4-meter walk speed test, walking impairment questionnaire, and muscle biopsy.
~Supervised exercise and leg revascularization patients will return in 12 weeks and have the same study procedures as testing visit 1, plus an ankle brachial index, repeated."
15920916|NCT03490955|Other|salad dressing (canola oil) and black pepper|Subjects will consume a vegetable salad with black pepper and dressing (canola oil) one time in the morning
15920917|NCT03490955|Other|salad dressing (canola oil)|Subjects will consume a vegetable salad with dressing (canola oil) one time in the morning
15920918|NCT03490955|Other|black pepper|Subjects will consume a vegetable salad without dressing (canola oil) but with black pepper one time in the morning
15920919|NCT03490955|Other|salad|Subjects will consume a vegetable salad without dressing (canola oil) and without black pepper one time in the morning
15920920|NCT03490955|Other|Salad dressing (olive oil) and black pepper|Subjects will consume a vegetable salad with black pepper and dressing (olive oil) one time in the morning
15920921|NCT03490955|Other|Salad dressing (corn oil) and black pepper|Subjects will consume a vegetable salad with black pepper and dressing (corn oil) one time in the morning
15920922|NCT03490955|Other|Salad dressing (sunflower oil) and black pepper|Subjects will consume a vegetable salad with black pepper and dressing (sunflower oil) one time in the morning
15920923|NCT03490955|Other|Salad dressing (flaxseed oil) and black pepper|Subjects will consume a vegetable salad with black pepper and dressing (flaxseed oil) one time in the morning
15920924|NCT03490942|Drug|Glucagon|CSI-Glucagon is a room temperature stable, non-aqueous, liquid formulation of glucagon.
15920925|NCT03490942|Drug|Placebo|The placebo solution is a non-active formulation containing excipients only.
15920926|NCT03490929|Drug|Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON]|injection of Lumason (ultrasound contrast agent)
15920927|NCT03490929|Device|contrast-enhanced ultrasound|ultrasound of the abdomen after injection of ultrasound contrast agent (Lumason)
15920928|NCT03490916|Drug|Acetazolamide|Administration of Acetazolamide
15920929|NCT03490916|Drug|Placebo|Administration of Placebo
15920930|NCT03490903|Device|Virtual Reality|Subjects undergoing the Virtual Reality Intervention will be fitted with a VR headset and headphones, and undergo an immersive meditation experience provided by AppliedVR, Inc. The headphones will not be noise-cancelling, and the subject will be able to communicate with the physician or circulating nurse if needed.
15920931|NCT03490903|Drug|Fentanyl Injection|Fentanyl is commonly administered to treat pain during invasive procedures such as coronary angiography. Intravenous fentanyl injection dosages are determined by the physician operator, and administered by the circulating nurse.
15920932|NCT03490903|Drug|Midazolam injection|Midazolam is commonly administered to treat anxiety during invasive procedures such as coronary angiography. Intravenous midazolam injection dosages are determined by the physician operator, and administered by the circulating nurse.
15920933|NCT03490890|Other|Microwave ablaton|Patients with pathology verified GGO were treated with MWA.
15920934|NCT03490864|Dietary Supplement|Melatonin 1 mg|Melatonin (1mg) or placebo will be administered daily during the intervention. Melatonin capsules will be obtained from Life Extension (Ft. Lauderdale, FL). The investigational drug pharmacy (IDP) at Northwestern Memorial Hospital will encapsulate the melatonin pills so the placebo (lactose) and melatonin pills appear identical. We have worked with this IDP on other projects. The investigators on this study have experience in administering melatonin for investigational and clinical purposes.
15920935|NCT03490864|Dietary Supplement|Placebos|Melatonin (1mg) or placebo will be administered daily during the intervention. Melatonin capsules will be obtained from Life Extension (Ft. Lauderdale, FL). The investigational drug pharmacy (IDP) at Northwestern Memorial Hospital will encapsulate the melatonin pills so the placebo (lactose) and melatonin pills appear identical. We have worked with this IDP on other projects. The investigators on this study have experience in administering melatonin for investigational and clinical purposes.
15920936|NCT03490864|Other|Meal Timing|Subjects are instructed to maintain an extended overnight fasting period of 12-16 hours.
15920937|NCT03490864|Other|NON Meal Timing|Subjects are instructed to maintain their habitual meal timing.
15920938|NCT03490851|Other|Oatmeal + OatWell28CF Int 1|Intervention involves consumption of one cereal in the beginning of each visit of the crossover sequence.
15920939|NCT03490851|Other|Oatmeal + OatWell28CF Int 2|Intervention involves consumption of one cereal in the beginning of each visit of the crossover sequence.
15920940|NCT03490851|Other|Oatmeal + OatWell28CF Int 3|Intervention involves consumption of one cereal in the beginning of each visit of the crossover sequence.
15920941|NCT03490851|Other|Cream of Rice|Intervention involves consumption of one cereal in the beginning of each visit of the crossover sequence.
15920943|NCT03490825|Dietary Supplement|Melatonin 1 mg|Melatonin (1mg) will be administered daily during the intervention. Melatonin capsules will be obtained from Life Extension (Ft. Lauderdale, FL). The investigational drug pharmacy (IDP) at Northwestern Memorial Hospital will encapsulate the melatonin pills so the placebo (lactose) and melatonin pills appear identical. We have worked with this IDP on other projects. The investigators on this study have experience in administering melatonin for investigational and clinical purposes.
15920944|NCT03490825|Dietary Supplement|Placebos|Placebo will be administered daily during the intervention. The investigational drug pharmacy (IDP) at Northwestern Memorial Hospital will encapsulate the pills so the placebo (lactose/starch) and melatonin pills appear identical. We have worked with this IDP on other projects. The investigators on this study have experience in administering melatonin for investigational and clinical purposes.
15920945|NCT03490825|Other|Meal timing|Subjects are instructed to maintain an extended overnight fasting period of 12-16 hours.
15920946|NCT03490825|Other|Non-Meal timing|Subjects are instructed to maintain their habitual meal timing.
15920947|NCT03490812|Diagnostic Test|PET scan|Investigational PET scan as add-on to standard-of-care scan
15920948|NCT03490812|Other|Retrospective data analysis|Review of pre-existing data from January 1, 2001 through December 5, 2017
15920952|NCT03490747|Behavioral|Physical activity referral scheme|An 18-week physical activity referral scheme co-developed by a local multidisciplinary stakeholder group. Behaviour change support underpinned by Self-Determination Theory (Ryan & Deci, 2000) will be provided by an exercise referral practitioner at weeks 1,4,8,12 and 18 to facilitate increased physical activity levels. Patients will be supported to develop a tailored programme of physical activity that may involve use of the fitness centre facilities (e.g. swimming, group classes, gymnasium use), participation in community-based initiatives, and changes to habitual physical activity. Focus on promoting patient autonomy and tailoring activities to patient's preferences and needs. Subsidised access to fitness centre facilities for first 12 weeks.
15920953|NCT03490747|Behavioral|Usual care exercise referral scheme|A comparative usual care exercise referral scheme that includes fitness centre based activities (e.g. swimming, group classes, gymnasium use). Patients meet an exercise referral practitioner at their induction (week 1) and week 12 (post scheme). Patients are typically prescribed a gym-based, 12-week programme. Subsidised access to fitness centre facilities for 12 weeks.
15920954|NCT03490734|Dietary Supplement|Black Cherry and Orange Flavored Beverage with added sugar|10 oz daily for three weeks
15920955|NCT03490734|Dietary Supplement|Strawberry Kiwi &Lemonade Flavored Beverage with added sugar|10 oz daily for three weeks
15920956|NCT03490734|Dietary Supplement|Black Cherry and Orange Flavored Beverage no added sugar|10 oz daily for three weeks
15920957|NCT03490734|Dietary Supplement|Strawberry Kiwi & Lemonade Flavored Beverage no added sugar|10 oz daily for three weeks
15920958|NCT03490734|Other|Tasteless Beverage|A solution of water, potassium chloride, and sodium bicarbonate. Three mL administered per associated logo presentation only during MRI procedure.
15920959|NCT03490721|Other|Clustering care|During 20 minutes, preterm infants will receive a cluster care with 2 minutes of hand containment.
15920960|NCT03490708|Drug|Tranilast|Subjects will be treated with tranilast
15920961|NCT03490695|Other|Practice Facilitation|Community health nurses trained in implementing the evidence-based TASSH protocol will be employed as Practice Outreach Facilitators (POF) to train the CHPS community health officers to deliver TASSH. The POFs will be required to complete an intensive 12-week training course focused on adoption of TASSH protocol to identify patients at risk for uncontrolled HTN, initiate behavioral lifestyle counseling, and Refer patients to the community health centers for drug therapy. Over the course of 12 months, the POFs will provide support to their assigned CHPS zones to implement TASSH as part of routine patient care.The POFs will also work with CHPS directors to review current work flow and develop a plan of action for TASSH uptake at the CHPS zones.
15920962|NCT03490695|Other|Usual Care|Provide Ghana's National Health Insurance, behavioral counseling and referral for care through the usual care system for 12 months.
15920963|NCT03490682|Other|Ultrasound assessment of gastric emptying of a flavoured yoghourt.|Each participant will be placed on a table, in the semi-recumbent position with elevation of the head at 45° and a first ultrasound examination will be performed. After that, the participant will be invited to eat a test meal (flavoured yoghurt) in 5 minutes. An ultrasound examination of the antrum allowing measurement of the antral area will be performed at 15, 60, 90 and 120 minutes after the end of the ingestion of the test meal. The participant must stay in the semi-recumbent position during the total duration of the study. The non-invasive ultrasound measurement, of the antral cross-sectional area is performed using a Sonosite ultrasound equiped with a 2 -5.5MHz probe. The diameters (longitudinal D1 and anteroposterior D2) of the antrum are measured in the sagittal plane passing by the abdominal aorta and the left lobe of the liver. The value of the antral cross-sectional area is given by the formula : Antral area = π x D1 x D2 / 4.
15920964|NCT03490669|Biological|MSC-1|humanized monoclonal antibody for intravenous administration
15920965|NCT03490656|Diagnostic Test|MRI Scan - in addition to standard of care|Up to 3 Tesla (T) MRI
15920966|NCT03490656|Diagnostic Test|MRI Scan - not in addition to standard of care|Up to 3 Tesla (T) MRI
15920967|NCT03490643|Other|Postural Analysis|posture and plantar pressure analysis
15920968|NCT03490643|Other|plantar pressure analysis|posture and plantar pressure analysis
15920969|NCT03490617|Drug|Vaginal misoprostol|To determine effectiveness of vaginal misoprostol to facilitate IUD insertion in nulligravida women
15920970|NCT03490604|Device|wrist-worn accelerometer|accelerometer worn on the patient's wrist, changed every 15 ± 7 days for 6 months when the patient comes for a chemotherapy session
15920971|NCT03490604|Other|Auto-questionnaires|Questionnaire regarding physical activity over the previous 7 days, questionnaires EORTC QLQ-C30 and EORTC QLQ-PAN26
15920972|NCT03490591|Behavioral|Robot-assisted hand rehabilitation|Robot-assisted hand rehabilitation: 20 minute of warm-up exercise and 40 minute of robot-assisted hand exercise intervention. Robot-assisted hand exercises include passive range of motion of hand, bilateral hands task, robot-assisted task, and game task.
15920973|NCT03490578|Device|Robot-assisted gait training|Patients should use their belts (Harness) to support their weight when walking in equipment. In the first training session, the patient focuses on fitting and adapting the equipment and helps the patient learn. To minimize skin damage, the patient can wear a protector. The initial walking speed starts at 1.0 km/h and can be increased gradually to 3.0 km/h. The gait robot provides an auditory feedback according to gait cycle and a visual feedback on the patient's active participation. If the patient can tolerate, the gait robot may control the walking speed automatically according to the patient's participation. The treatment time per session is 45 minutes including don and doff time. Total 12 sessions are provided for 4 weeks.
15920974|NCT03490578|Device|Intensive treadmill training|Patients exercise on the treadmill. The initial walking speed starts at 1.0 km/h and can be increased gradually to 3.0 km/h. The therapist provides appropriate visual and auditory instructions to allow the patient to participate in the treadmill training. The treatment time per session is 45 minutes including warm-up and cool-down. Total 12 sessions are provided for 4 weeks.
15920999|NCT03490344|Drug|Lenalidomide|Lenalidomide maintenance therapy to be administered as standard treatment to all participants. This is administered as 5-15 mg daily 21-28/28 day cycle.
15921027|NCT03490110|Behavioral|State regulation skill training|Participants complete seven supervised training sessions. Training sessions last 2 hours, and participants are requested to complete approximately 2.5 hours of additional skill practice over the course of each week outside of session (total ~4.5 hours per week).
15921028|NCT03490110|Other|Treatment-as-usual|Participants receive clinical care as usual over a matched time period.
15920975|NCT03490565|Behavioral|Exercise training|Structured, supervised, high-intensity combined aerobic and resistance exercise. Based on patients' individual capacity (Wattmax and 1RM), a personalized exercise program will be prescribed. Following a 5 minutes warm up, the patients will perform 21 min of aerobic interval training on a stationary bicycle consisting of three 4 minute high intensity intervals (85-95% HRmax) with 3 minutes of active pause between each interval. The resistance training comprises 4 functional exercises by performed using bodyweight, elastic resistance bands or kettlebells followed by resistance exercises in machines for the major muscle groups: chest press, leg press, seated rows, and leg extension with 1 warm-up set followed by 3-4 sets of 8 to 12 repetitions.
15920976|NCT03490552|Procedure|mechanical thrombectomy|Mechanical thrombectomy whatever it type ( SRT , ASPT or Mixed )will be used to extract the thrombi from stroke causing occlusion to be preserved biologically for genomic lab. transfer to be processed by RNA sequencing analysis technique for identifying markers for its composition pointing to its source.
15920977|NCT03490539|Drug|Mycophenolate Mofetil|oral tablets
15920978|NCT03490539|Drug|Azathioprine|oral tablet
15920979|NCT03490526|Device|Root canal disinfection with XP-endo Finisher|The XP-Endo® finisher will be used next to the X-Smart Plus endodontic motor, with speed settings at 800rpm and torque at 1 N.cm. Irrigation with 17% EDTA and 2.5% NaOCl will be performed in three cycles of one minute each. In each cycle the XP-Endo will be used in the working length in continuous and slow movements of entrance and exit, with amplitude of 5mm, for a period of 1 minute, followed by new irrigation with 2.5ml of EDTA solution or hypochlorite of sodium 2,5%. Finally, the channel will be completely dry with absorbent paper tips
15920980|NCT03490526|Device|Root canal disinfection with passive ultrasonic irrigation|For cleaning using passive ultrasonic irrigation, the E1 Irrisonic tip (Helse Ultrasonic, Ribeirão Preto, SP), will be used with Jetlaxis Sonic BP LED (Schuster, Santa Maria, RS). The insert has a diameter equivalent to a manual file 20, with reduced taper (0.01). The power used will be 10%. With root canals flooded with 17% EDTA, the irrigation tips will be coupled to the ultrasound and 1mm shorter than the working length. These tips will be kept in the center of the canal avoiding contact with the dentin walls. The irrigation will be performed in three cycles, and in each cycle the irrigation tips will be activated for 1 minute followed by new irrigation with 2.5ml EDTA. The same procedure will be repeated with 2.5% NaoCl. Finally, the channel will be completely dry with absorbent paper tips.
15920981|NCT03490513|Drug|anastrozole (1 mg/day)|Participants will take Anastrozole 1mg per day, attend behavioral classes conducted by a dietitian, receive instruction on how to loss 10% of their body weight and participate in a supervised exercise training program.
15920982|NCT03490513|Drug|Placebo|Participants will take a placebo tablet every day, attend behavioral classes conducted by a dietitian, receive instruction on how to loss 10% of their body weight and participate in a supervised exercise training program.
15920983|NCT03490487|Drug|conventional antiepileptic drugs|will receive conventional antiepileptic drugs only. EEG, attention deficit hyperactivity disorder test and intelligence quotient will be done before and 3 months after treatment.
15920984|NCT03490487|Drug|oral steroid|will receive oral steroid for 3 months beside conventional antiepileptic drugs. EEG, attention deficit hyperactivity disorder test and intelligence quotient will be done before and 3 months after treatment.
15920985|NCT03490474|Other|Pain Inducing Massage|Participants will receive 60 seconds of manual pressure applied to one myofascial trigger point so the participant rates the pain = 5/10 on a scale from 0 to 10. This will be followed by 30 seconds of complete pressure release. This will occur 4 times.
15920986|NCT03490474|Other|Pain Free Massage|Participants will receive 60 seconds of light touch applied to one myofascial trigger point so the participant rates the pain = 0/10 on a scale from 0 to 10. This will be followed by 30 seconds of complete pressure release. This will occur 4 times.
15920987|NCT03490474|Other|Coldpressor|Participants will place their non-dominant hand into water cooled by a refrigeration unit temperature of 6 degrees Celsius (males) or 8 degrees Celsius (females). The participant will place his or her hand in the cooled water for 60 seconds followed by a 30 second break in which the participant will remove his or her hand from the water. This will occur 4 times.
15920988|NCT03490461|Drug|Statin|Patients who used statins over 1 month for the treatment of dyslipidemia after LT were enrolled as statin group.
15920989|NCT03490448|Behavioral|aerobic exercise and appropriate caloric control|The dietary was designed on the basis of ensuring the daily energy physiological requirement, and basal metabolic rate (BMR) was calculated to formulate diet project according to Harris-Benedict formula. The diet was composed of 20% protein, 30% fat and 50% carbohydrates.In the exercise, heart rate was monitored to ensure the small-medial load aerobic exercise. All kinds of sports were conducted indoor, twice per day, 6 days per week, and lasted for 2 hours every time.
15920990|NCT03490435|Diagnostic Test|Tests for diagnosis of intestinal parasitic diseases|"Feces testing:
~fresh fecal samples will be used to preparing direct (saline and iodine wet) mounts using supplementary techniques (flotation, sedimentation), as well as temporary mounts (hematoxylin and trichrome staining). Other technique of fresh fecal samples examination will be ParaSys™
~A non-preserved stool samples will be stored below -20°C. Defrosted fecal specimen will be subjected to enzyme-linked immunosorbent assays (ELISA) - Giardia antigen test (coproantigens)"
15920991|NCT03490422|Procedure|Pulpotomy|Pulpotomy in mature carious permanent teeth
15920992|NCT03490409|Device|Thigh compression stocking|Thigh compression stocking
15920993|NCT03490396|Device|Gelclair|Polyvinylpyrrolidone (PVP) and Sodium Hyaluronate-Containing Oral Gel
15920994|NCT03490396|Combination Product|First® Mouthwash BLM|Viscous Lidocaine, Diphenhydramine, and Aluminum-magnesium Hydroxide/Simethicone Antacid Suspension Mouthwash
15920995|NCT03490370|Device|Electro-muscular stimulation using NeuroTrac MyoPlus 2/4|In this pilot study we aim to determine if change in the muscle metabolism can resolve insulin resistance in NAFLD through muscle stimulation by using electro-stimulation. We hypothesise that 6x35 minute sessions per week over a 12 week time scale would mimic effects of resistance exercise on metabolic parameters associated with NAFLD and hepatic steatosis. All 20 participants will have the electro-stimulation intervention.
15920996|NCT03490357|Procedure|Control - Transversus Abdominus Plane Block|Abdominal fascial plane block - regional anesthesia
15920997|NCT03490357|Procedure|Quadratus Lumborum Block|Abdominal fascial plane block - regional anesthesia
15921029|NCT03490097|Drug|Simvastatin 10mg|tablets
15921030|NCT03490097|Drug|sofosbuvir plus daclatasvir|sofosbuvir 400mg daclatasvir 60 mg daily for 12 weeks.
15921000|NCT03490331|Other|Transplantation surgery of genetically corrected cultured epidermal autograft (ATMP)|Surgergical procedure for transplantation under anaesthesia of genetically corrected cultured epidermal autograft (Hologene17) on blistering skin areas of JEB patients. By taking some autologous epidermal cells, a new layer of transgenic tissue is grown in the laboratory. This layer of tissue - containing genetically modified stem cells - is then implanted by a surgeon into the damaged area. The implantation can be done in one or more areas and repeated in case of failure of the first surgery.
15921001|NCT03490305|Procedure|Exploratory laparotomy|Findings and procedures done at exploratory laparotomy
15921002|NCT03490292|Combination Product|Avelumab combined with Chemoradiation|Co-administration of avelumab with chemoradiation in pre-operative period.
15921003|NCT03490292|Drug|Carboplatin|Weekly Carboplatin (AUC2) [intravenous infusion on days 1, 8, 15, 22, & 29]
15921004|NCT03490292|Drug|Paclitaxel|Weekly paclitaxel [intravenous infusion on days 1, 8, 15, 22, & 29]
15921005|NCT03490292|Radiation|Radiation|Radiation therapy [23 fractions, M-F, estimated completion day 35]
15921006|NCT03490279|Dietary Supplement|Lactoferrin CRX|Patients will be asked to take lactoferrin CRX as already mentioned (blindly).
15921007|NCT03490279|Other|Placebo|Patients will be asked to take placebo as already mentioned (blindly).
15921008|NCT03490266|Procedure|Robotic Repair|The surgeon will be utilizing a robotic system to repair the hernia.
15921009|NCT03490266|Procedure|Laparoscopic Repair|The surgeon will be repairing the hernia laparoscopically.
15921010|NCT03490253|Behavioral|DIAMANTE Adaptive|In a three arm randomized controlled trial we will examine the effect of a text-messaging smartphone application to encourage physical activity in low-income ethnic minority patients with comorbid diabetes and depression. The adaptive intervention group receives messages chosen by a reinforcement learning algorithm.
15921011|NCT03490253|Behavioral|DIAMANTE Static|The static intervention group receives health information text-messages, typical of existing text-messaging interventions for diabetes and depression.
15921012|NCT03490240|Behavioral|BIPAMS|"The primary content of the website is delivered through interactive video courses. The interactive video courses are released seven times during the first two months, four times during the second two months, and twice during the final two months of the intervention.
~Another key part of the website is the Tracker feature. This feature allows for tracking of daily step counts (via Yamax SW-200 pedometer) as well as setting goals and monitoring progress over the program.
~The one-on-one video chats are conducted face to face through skype and are semi-scripted. The chats consist of an ongoing review of goal-setting and progress toward goal attainment through Tracker as well as discussion of strategies and facilitators of behavioral change based on SCT and current website content. The chats occur seven times during the first two months, four times during the second two months, and twice during the final two months of the intervention."
15921013|NCT03490240|Behavioral|WELLMS|The control condition focuses on self-managing MS through means other than physical activity. The materials are transformations of brochures provided by the NMSS, including Gait or Walking Problems: The Basic Facts; MS and Your Emotions; Pain: The Basic Facts; Solving Cognitive Problems; Taming Stress in MS; Food for Thought: MS and Nutrition; and Vitamins, Minerals, and Herbs: An Introduction. The delivery of the Internet materials and chat sessions will occur on the same time schedule and frequency as the intervention condition, and will have a comparable time commitment. The control condition will account for attention and social contact as well as other possible biases such as initial reactivity and time spent on the website and video chats. The participants in the control condition will not be offered the behavioral intervention for increasing physical activity after completion of the study procedures.
15921014|NCT03490214|Device|Multispectral Optoacoustic Tomography|Non-invasive transcutaneous imaging of subcellular muscle components
15921015|NCT03490201|Device|Market Approved RF Ablation System|Subjects receive ablation using an FDA approved ablation system.
15921016|NCT03490201|Device|FlexAbility SE Ablation Catheter|Subjects receive ablation treatment using an ablation system that is not FDA approved.
15921017|NCT03490188|Behavioral|Discharge Mentoring|Phone Conversations on the importance of complying to discharge instructions delivered before discharge
15921018|NCT03490162|Drug|DM1157|DM1157 is a novel anti-malarial drug that is derived from chloroquine. DM1157 maintains the efficacy of chloroquine and has molecular features that overcome resistance to chloroquine.
15921019|NCT03490162|Other|Placebo|Placebo
15921020|NCT03490149|Device|Electroconvulsive Therapy|Series of electroconvulsive therapy for major depressive disorder
15921021|NCT03490149|Drug|Medication - Treatment as usual|Medication only sample - Treatment as usual
15921022|NCT03490123|Drug|R1-Total community treatment with azithromycin|At month 0, all study participants (regardless of their yaws status) will receive 30 mg/Kg (maximum 2 g) of azithromycin orally under direct observation. Benzathine benzylpenicillin will be reserved as a backup for patients who cannot be treated with AZI, and who are not allergic to penicillin.
15921023|NCT03490123|Drug|R2-Total community treatment with azithromycin|At month 6, all study participants (regardless of their yaws status) will receive 30 mg/Kg (maximum 2 g) of azithromycin orally under direct observation. Benzathine benzylpenicillin will be reserved as a backup for patients who cannot be treated with AZI, and who are not allergic to penicillin.
15921024|NCT03490123|Drug|R3-Total community treatment with azithromycin|At month 12, all study participants (regardless of their yaws status) will receive 30 mg/Kg (maximum 2 g) of azithromycin orally under direct observation. Benzathine benzylpenicillin will be reserved as a backup for patients who cannot be treated with AZI, and who are not allergic to penicillin.
15921025|NCT03490123|Drug|R2-Total targeted treatment with azithromycin|At 6 months, study participants will be screened for active yaws. Participants with yaws and their contacts will receive 30 mg/Kg (maximum 2 g) of azithromycin orally under direct observation. Benzathine benzylpenicillin will be reserved as a backup for patients who cannot be treated with AZI, and who are not allergic to penicillin.
15921026|NCT03490123|Drug|R3-Total targeted treatment with azithromycin|At 12 months, study participants will be screened for active yaws. Participants with yaws and their contacts will receive 30 mg/Kg (maximum 2 g) of azithromycin orally under direct observation. Benzathine benzylpenicillin will be reserved as a backup for patients who cannot be treated with AZI, and who are not allergic to penicillin.
15921092|NCT03489616|Drug|Pemetrexed|Pemetrexed (brand name Alimta) is a chemotherapy drug manufactured and marketed by Eli Lilly and Company. Its indications are the treatment of pleural mesothelioma and non-small cell lung cancer.
15921031|NCT03490084|Other|Association of day hospitalization with hospital-at-home|Patients receive the first administration of chemotherapy through day hospitalization in the hematology department, then 3 weekly administrations of chemotherapy at home.
15921032|NCT03490084|Other|Day hospitalization exclusively|Patients receive 4 weekly administrations of chemotherapy through day hospitalization in the hematology department.
15921033|NCT03490058|Drug|Truvada|A fixed dose of oral co-formulated tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC) will be used as PrEP.
15921034|NCT03490045|Other|Diaper Incentive|A diaper incentive will be distributed to participants in the Intervention condition at 4-time points, which will coincide with the well-child visits that occur at 2-weeks, 2-months, 4-months, and 6-months. A follow-up assessment will also occur approximately 3 months after the family received their final distribution of diapers.
15921035|NCT03490045|Other|Conditional Cash Transfer Condition|Participants in the control condition will receive the cash equivalent value of the diapers distributed to the Experimental Condition for their participation at 4-time points, which will coincide with the well-child visits that occur at 2-weeks, 2-months, 4-months, and 6-months. A follow-up assessment will also occur approximately 3 months after the family received their final conditional cash transfer.
15921036|NCT03490032|Drug|[68Ga]-PSMA-R2|radio-labelled PSMA ligand
15921037|NCT03490019|Drug|Metformin|500, 850 or 1000 mg depending on body weight once daily for 24 weeks
15921038|NCT03490006|Procedure|Erector Spinae Plane Block|A relatively recent alternative to the paravertebral block is the thoracic erector spinae plane block, which involves the ultrasound-guided injection of local anesthetic into the interfascial plane deep to the erector spinae muscle at the level of the transverse process. It results in a loss of somatic sensory sensation across multiple unilateral dermatomes due to local anesthetic mediated blockade of the dorsal and ventral rami of the spinal nerve roots. It is increasingly being used due to ease of placing the block and a perception of greater safety. It has been shown to provide pain relief from rib fractures, thoracotomy, and chronic neuropathic pain of the chest wall. However, to date, erector spinae plane block has not been compared with paravertebral block in regards to analgesia with mastectomy surgery, which has been extensively studied.
15921039|NCT03490006|Procedure|Paravertebral Block|Paravertebral block is a classic regional anesthesia technique that has been in use for over 100 years. It is performed by the injection of local anesthetic into the space between the costotransverse ligament and parietal pleura resulting in blockade of ipsilateral intercostal nerves. It results in a loss of somatic sensation over multiple unilateral dermatomes.
15921040|NCT03489993|Diagnostic Test|Ang II and Ang-(1-7)|Measured in plasma and urine using radioimmunoassays.
15921041|NCT03489993|Diagnostic Test|FGF23 and klotho|Measured using ELISA's.
15921042|NCT03489980|Other|coloring-type artistic task of a complex form|coloring-type artistic task of a complex form
15921043|NCT03489967|Other|Induced-hypoglycemia test|Participants will be admitted at the research center at 7:00 after an overnight fast. A venous catheter will be inserted into an arm vein for blood sampling purposes. A subcutaneous insulin bolus will be administered to induce hypoglycemia. Oral treatment (16g of carbohydrates or 32g of carbohydrates) will be given when plasma glucose levels are at the target threshold of < 3.0 mmol/L or 3.0-3.5 mmol/L. Hypoglycemia symptoms will be assessed every 10 minutes by the participant using a validated scale starting from the time of insulin bolus until hypoglycemia recovery. One hour after hypoglycemia recovery, a standardized meal will be given.
15921044|NCT03489954|Other|Evaluation|Deep cervical flexor muscle endurance, neck position sense and body balance will be measured.
15921045|NCT03489941|Drug|EM-100|Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.
15921046|NCT03489941|Drug|Zaditor®|Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.
15921047|NCT03489941|Drug|Vehicle|Subjects will receive one drop in one eye only based on the randomization list, one time over the course of the trial.
15921048|NCT03489928|Drug|Oral Misoprostol|Prostaglandin E1 - 100ug tablet, divided in half by pharmacy staff to be administered by mouth.
15921049|NCT03489928|Drug|Vaginal Misoprostol|Prostaglandin E1 - 100ug oral tablet, divided in quarters by pharmacy staff, vaginal placement of one or two quarters as needed every 6 hours
15921050|NCT03489928|Drug|Dinoprostone|Prostaglandin E2 - 1-2mg gel manufactured for vaginal use; placed vaginally every 6 hours as needed.
15921051|NCT03489915|Device|OCT|Assessment of macular edema secondary to retinal vein occlusion usin optical coherence tomography and its correlation with visual acuity
15921052|NCT03489902|Procedure|Transobturator Paravaginal Repair|Transobturator application of sutures to the white line in cases needing paravaginal repair
15921053|NCT03489902|Procedure|traditional transvaginal Paravaginal Repair|traditional transvaginal application of sutures to the white line
15921054|NCT03489889|Drug|Ursodeoxycholic Acid 300mg tablet|Cross-over study: Ursodeoxycholic Acid 300mg tablet and after Ursodeoxycholic Acid 300mg capsule
15921055|NCT03489889|Drug|Ursodeoxycholic Acid 300mg capsule|Cross-over study: Ursodeoxycholic Acid 300mg capsule and after Ursodeoxycholic Acid 300mg tablet
15921056|NCT03489876|Device|Synthetic Cartilage Implant|The Synthetic Cartilage Implant will be implanted in to the first metatarsal head according to the manufacturer's recommendations.
15921057|NCT03489876|Procedure|Osteochondral Autograft Transfer|The osteochondral autograft transfer will be harvested from the ipsilateral lateral femoral condyle (or contralateral if a previous ipsilateral total knee anthroplasty or trauma) and the graft will be transferred to the first metatarsal head.
15921058|NCT03489863|Drug|Prasugrel|Maintenance dose will be maintained for 10±3 days.
15921059|NCT03489863|Drug|Ticagrelor|Maintenance dose will be maintained for 10±3 days.
15921060|NCT03489850|Drug|Ibudilast|Ibudilast (IBUD) is a neuroimmune modulator that inhibits phosphodiesterase-4 and -10 and macrophage migration inhibitory factor.
15921061|NCT03489850|Other|Placebo|Placebo is matched to ibudilast active medication.
15921062|NCT03489837|Drug|Levotuss|oral taken
15921093|NCT03489616|Radiation|Local Radiotherapy|Radiotherapy promotes the release of tumor antigen
15921094|NCT03489616|Drug|Single agent|Other chemotherapy drugs,such as Docetaxel, gemcitabine
15921192|NCT03488667|Drug|Neoadjuvant Treatment - mFOLFOX6 & Pembrolizumab|Pembrolizumab, mFOLFOX Chemotherapy
15921193|NCT03488667|Drug|Adjuvant Treatment - mFOLFOX & Pembrolizumab|Pembrolizumab, mFOLFOX Chemotherapy
15921063|NCT03489824|Procedure|modified- WIM colonoscopy|Modified-water immersion method of colonoscopy refers to the freely episodic suction of the infused-water during colonoscopy insertion phase at a moment to negotiate the angulated colon to facilitate cecal intubation but not suction the mucosa. The original water immersion method only suctions the water when the colon is over-distended or it is dirty and exchanges it with the new cleans water during insertion then evacuates all of the water during withdrawal
15921064|NCT03489811|Other|Test Essential Oil Blend|The test essential oil blend consists of plant derived oils which have been distilled from crude plant matter and analyzed in a laboratory to identify chemical composition.
15921065|NCT03489811|Other|Active Essential Oil Blend|The active essential oil blend consists of plant derived oils which have been distilled from crude plant matter and analyzed in a laboratory to identify chemical composition.
15921066|NCT03489811|Other|Control Blend|The control blend consists of inert vegetable oils which are produced from plant matter.
15921067|NCT03489798|Procedure|6 misoprostol|Up to 6 doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score > 6.
15921068|NCT03489798|Procedure|3 misoprostol|Up to 3 doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score > 6.
15921069|NCT03489772|Drug|ITI-214|Oral
15921070|NCT03489772|Drug|Placebo|Oral
15921071|NCT03489759|Device|ViE15-A|The type of dialytic treatment that will be used during the study will be continuous venous hemofiltration (CVVH-Continuous veno-venous hemofiltration). The filter will be ViE15-A.
15921072|NCT03489759|Device|REXEED-15A|The type of dialytic treatment that will be used during the study will be continuous venous hemofiltration (CVVH-Continuous veno-venous hemofiltration). The filter will be REXEED-15A.
15921073|NCT03489746|Other|ICS withdrawal protocol|A primary care intervention to support switch from ICS containing regimen to non-ICS containing regimen in appropriate patients.
15921074|NCT03489746|Other|Standard care|Normal clinically indicated inhaled therapy
15921075|NCT03489733|Other|Hydrolyzed Formula|Infant formula with extensively hydrolyzed proteins and pre- and probiotics.
15921076|NCT03489733|Other|Control formula|Infant formula with intact proteins and pre- and probiotics.
15921077|NCT03489720|Behavioral|Prescribed Exercise Program|"Brief cardiovascular exercise training (>70% of maximum heart rate) for 15 minutes a day, 5 days a week for 8 weeks.
~The exercise intervention will be a 15-minute per day of vigorous exercise that as monitored by a Fitbit Charge 2.
~Examples of possible 15-minute exercise regimens to be used include:
~Walking quickly or running up and down stairs
~Plyometric exercises such as jumping jacks, high knees, squats, lunges, speed skaters, froggers, etc
~Walking up an incline on a treadmill
~Jogging or running on a treadmill or elliptical
~Stationary cycling or rowing"
15921078|NCT03489720|Behavioral|Usual Exercise Program|Usual exercise activity for 8 weeks
15921079|NCT03489707|Behavioral|Home-based human papillomavirus (HPV) DNA screening|Persons randomized to arm 1 will receive an HPV DNA home-based collection kit in the mail at 0 and 12 months.
15921080|NCT03489707|Behavioral|Clinic-based human papillomavirus (HPV) DNA screening|Persons randomized to arm 2 will attend a clinic where a clinician will collect the DNA specimen at 0 and 12 months.
15921081|NCT03489694|Procedure|Skin test endpoint titration|An allergen that is suitable to cause skin reactions when introduced to the forearm through pricking will be administered in doubling concentrations.
15921082|NCT03489681|Device|acupuncture|"Low dose group:
~Twenty patients will assign for low dose group treatment; as six acupoints as Shensu (BL 54), Huantiao (GB 30), Weizhong (BL 40), Yanglingquan (GB 34), Kunlun (BL 60), Juegu (GB 39).
~High dose group:
~Twenty patients will assign for high dose group treatment. These acupoints contains of eighteen acupoints, as Shenshu (BL 54), Dachangshu (BL 25) , Xiaochangshu (BL 27), Huantiao (GB 30), Yinmen (BL 37) , Zhibien (BL 54), Chengfu (BL 36), Fengshi (GB 31), Weizhong (BL 40), Zusanli (ST 36) Yanglingquan (GB 34), Yinlingquan (SP 9), Feiyang (BL 58), Sanyinjiao (SP 6), Juegu (GB 39), KunLun (BL 60), , Taixi (KI 3), Shenmai (BL 62)."
15921083|NCT03489668|Drug|MetFORMIN 500 Mg Oral Tablet|metformin administration 1500mg per day
15921084|NCT03489655|Behavioral|Maintenance Phase Intervention|The CHW will utilize motivational interviewing techniques over phone calls to reinforce all asthma education provided in the AI phase, including asthma basics, triggers and reduction strategies, purpose of medications, and steps for proper medication use. The CHW will identify barriers the participant is facing in management of their asthma and set goals to overcome them. The CHW will encourage regular visits with the Primary Care Physician and assist with referrals for other medical and social services, as needed. CHWs will check-in with participants via phone, monthly for the first 6 months and bi-monthly in the remaining 6 months Participants will receive bi-monthly data collection follow-up phone calls by a Research Assistant.
15921085|NCT03489642|Behavioral|Telehealth Program|Telehealth program delivered remotely to study participants. Program developed by Cambium Technologies.
15921086|NCT03489629|Drug|Trimethoprim Sulfamethoxazole (TMP/SMX)|"Dosing if < 40 kg: 8 mg/kg trimethoprim/40 mg/kg trimethoprim sulfamethoxazole given twice daily for 14 days during Days 1-14 and Days 29-42.
~Dosing is ≥ 40 kg: 320 mg/1600 mg twice daily for 14 days during Days 1-14 and Days 29-42."
15921087|NCT03489629|Drug|Minocycline|"If a subject has an allergy to or intolerance to TMP/SMX, they may be treated with minocycline provided they are 8 years of age or older.
~Dosing if < 50 kg: 2 mg/kg orally twice daily for 14 days during Days 1-14 and Days 29-42.
~Dosing if ≥ 50 kg: 100 mg twice daily for 14 days during Days 1-14 and Days 29-42."
15921088|NCT03489629|Drug|Mupirocin|1 gram 2% nasal ointment generously applied to each nostril using a cotton swab twice daily for 5 days during Days 1-5 and Days 29-33.
15921089|NCT03489629|Drug|Chlorhexidine Gluconate|For subjects able to swish without swallowing, 0.12% chlorhexidine gluconate oral rinse will be used twice daily for 14 days during Days 1-14 and Days 29-42.
15921090|NCT03489629|Behavioral|Environmental Decontamination|"Subjects will be instructed to wipe down all high touch surfaces and medical equipment with surface disinfection wipes daily during Days 1-21 and Days 29-49.
~Subjects will also be instructed to wash all linens and towels in hot water once weekly during weeks 1-3 and weeks 5-7."
15921091|NCT03489616|Biological|rhGM-CSF|rhGM-CSF is a stimulator of the growth and differentiation of hematopoietic progenitor cells committed to neutrophils, monocytes or eosinophils. rhGM-CSF can promote the maturation of dendritic cells and macrophage, increase their antigen presentation ability.
15921130|NCT03489213|Other|Laboratory Biomarker Analysis|Correlative studies
15921095|NCT03489590|Drug|PFP|"Composition: inhaled PFP, a gaseous contrast agent (79% PFP, 21% O2, pre-mixed, medical grade gas)
~Administration: Full-face disposable ventilation mask and a standard Douglas Bag system.
~Dosage: Two controlled breaths of contrast gas followed by a full breath and a 12-second breath-hold and scan for image acquisition.
~Frequency: Repeated 5 times followed by an identical five cycles with room air to ensure PFP gas wash-out has occurred."
15921096|NCT03489564|Behavioral|Active|No behavioral intervention included but the exposure is level of physical activity. Individuals in the Active group will be categorized by their own routine physical activity levels.
15921097|NCT03489564|Behavioral|Sedentary|No behavioral intervention included but the exposure is level of physical activity. Individuals in the Sedentary group will be categorized by their own routine physical activity levels.
15921098|NCT03489551|Drug|Haldol|
15921099|NCT03489538|Procedure|laparoscopic long limb roux-en-Y gastric bypass|standard laparoscopic roux-en-Y gastric bypass (biliopancreatic limb 40 to 60 cm, alimentary limb 150 cm)
15921100|NCT03489525|Biological|Dose Escalation, MEDI2228, ADC (antibody drug conjugate)|Single agent MEDI2228 will be administered to adult subjects with R/R MM. The study aims to evaluate up to 9 planned, sequentially ascending main dose levels
15921101|NCT03489525|Biological|Dose Expansion, MEDI2228, ADC (antibody drug conjugate)|Adult subjects with R/R MM with measurable disease will be enrolled in the dose-expansion cohort at the dose selected for evaluation in the dose-expansion phase.
15921102|NCT03489512|Drug|A (Chloraprep)|Chloraprep will be used for the insertion and maintenance of the intravascular device while it is in use (Chlorhexidine 2% + alcohol 70%)
15921103|NCT03489512|Drug|B (Clorhexidine 2%)|Aqueous clorhexidine (2%) will be used for the insertion and maintenance of the intravascular device while it is in use
15921104|NCT03489473|Diagnostic Test|18F-FES PET CT scan|PET CT scan with estrogen tracer
15921105|NCT03489460|Behavioral|Specialized sleep-related message interventions|Over the course of 2 weeks' participants will receive specialized sleep-related message interventions to encourage sleep awareness via the smartphone application.
15921106|NCT03489460|Behavioral|GAD|Survey responses will be merged with objective GAD data (sleep time, time in deep sleep, physical activity) which will assist in developing message design formats for message testing.
15921107|NCT03489447|Other|ICU care|exposure to ICU treatment with or without diagnosed sepsis
15921108|NCT03489434|Behavioral|Intervention|Preliminary prevention program component content is based on evidence-based prevention programs and will integrate prevention content for substance use, sexual assault, and sexual risk behaviors.
15921109|NCT03489408|Device|Conventus Cage™ PH|Proximal humeral fracture fixation
15921110|NCT03489395|Drug|Edoxaban|Edoxaban 60 mg once a day for 4 weeks. Edoxaban 30 mg/day in patients with body weight ≤60 kg, or with concomitant therapy with verapamil/quinidine/dronedarone.
15921112|NCT03489369|Drug|Sym022|Sym022 is a recombinant, fully human antibody that binds LAG-3 and blocks the LAG-3/major histocompatibility complex class II (MHC-II) interaction, thus allowing for increased T-cell proliferation and cytokine production.
15921113|NCT03489356|Behavioral|Addressing Behavior Change (ABC)|The ABC is a 3-minute brief, dermatologist delivered intervention for dermatological patients that takes place during a skin examination. During the ABC intervention, dermatologists specifically assess patients' UV risk behaviors, discuss patients' motivation to use UV protection, and explore solutions to patient-reported barriers interfering with effective sunscreen use. Based on our previous research, the ABC intervention does not add additional time to the visit, but rather replaces treatment as usual conversations about sun protection.
15921114|NCT03489343|Drug|Sym023|Sym023 is a recombinant, fully human antibody that binds TIM-3 and induces activation of immune cells.
15921115|NCT03489317|Drug|Metformin|Participants with high glucose levels will usually be prescribed Metformin 250 mg three times daily. Can be prescribed to either metabolic syndrome-partial or full groups depending on their metabolic syndrome conditions.
15921116|NCT03489317|Behavioral|lifestyle modification|Participants with metabolic syndrome will be offered advice on modifying their diets and exercise regimes. Can be prescribed to either metabolic syndrome-partial or full groups depending on their metabolic syndrome conditions.
15921117|NCT03489317|Drug|Simvastatin 10mg|Participants with elevated lipid levels will usually be prescribed simvastatin 10 mg at night. Can be prescribed to either metabolic syndrome-partial or full groups depending on their metabolic syndrome conditions.
15921118|NCT03489317|Drug|Amlodipine 5mg|Participants with high blood pressure could be prescribed antihypertensive medicine such as Amlodipine. Can be prescribed to either metabolic syndrome-partial or full groups depending on their metabolic syndrome conditions.
15921119|NCT03489304|Drug|Zaleplon|non-benzodiazepine hypnotic agent
15921120|NCT03489291|Genetic|AAV5-hFIXco-Padua (AMT-061)|Single intravenous infusion of AAV5-hFIXco-Padua (AMT-061)
15921121|NCT03489265|Drug|Eluxadoline 100 mg|100 mg capsule-shaped tablet by mouth taken twice per day
15921122|NCT03489265|Other|Placebo|Matching capsule-shaped placebo tablets taken by mouth twice per day
15921124|NCT03489239|Drug|Tenofovir Alafenamide|subjects switching from Entecavir to single arm TAF 25mg
15921125|NCT03489226|Dietary Supplement|Capsimax|Capsimax
15921126|NCT03489226|Dietary Supplement|Placebo|Placebo
15921127|NCT03489226|Other|Meal|Meal
15921128|NCT03489213|Other|Dietary Intervention|Participants randomized to the DGA/AICR group will receive plant-based diet education, garden access and health coaching for 5 months. The sessions are offered every other week.
15921129|NCT03489213|Behavioral|Exercise Intervention|Participants will wear a FitBit every day and monitor daily physical activity.
15921131|NCT03489213|Dietary Supplement|Nutritional Intervention|Participants randomized to the beef group will receive 11 to 18 ounces of frozen lean beef each week for home preparation, in addition to DGA/AICR diet education, garden access and health coaching.
15921132|NCT03489213|Other|Questionnaire Administration|Ancillary studies
15921133|NCT03489200|Other|EH301|1-(beta-D-Ribofuranosyl)nicotinamide chloride and 3,5-Dimethoxy-4'-hydroxy-trans-stilbene
15921134|NCT03489200|Other|Placebo|No intervention- placebo
15921135|NCT03489187|Device|Visualase Thermal Therapy System|Patients who have previously received treatment with VTTS when used as intended.
15921136|NCT03489174|Other|Monthly Pregnancy Screening|Pregnancy test will be administered once per month during weekly urine testing for drug levels.
15921137|NCT03489174|Other|Usual Care|Usual care.
15921138|NCT03489161|Drug|Buprenorphine|buprenorphine/naloxone 4mg/1 mg for Clinical Opioid Withdrawal Scale (COWS) scores between 8 and 12, or 8mg/2mg S/L ≥ 12 by the sublingual route
15921139|NCT03489148|Behavioral|Tamarkoz®|Tamarkoz® techniques includes six key elements: clearing the mind, breathing exercises, Movazeneh® (movement and balance exercises), deep relaxation, and visualization.
15921140|NCT03489148|Behavioral|Stress management resources|Use of the campus health center's stress management resources such as counseling, health-coaching, health and wellness groups, use of an automated massage chair, pet-an-animal a week, and online reading material about self-care for stress management.
15921141|NCT03489135|Device|ReVene Thrombectomy Catheter|Endovascular treatment of an acute iliofemoral DVT
15921142|NCT03489122|Behavioral|yoga|The yoga intervention consists of Iyengar yoga method and coherent breathing sessions for 90 minutes twice a week or a maximum of 24 interventions over the 12 week intervention.
15921143|NCT03489122|Behavioral|walking|The walking intervention consists of walking sessions at 2.5 miles an hour on a flat surface for 60 minutes twice a week or a maximum of 24 interventions over the 12 week intervention.
15921144|NCT03489109|Behavioral|Intermittent fasting|Subject will consume approximately 25% of their daily calories for 2 days per week. The other 5 days they will eat their normal diet
15921145|NCT03489109|Other|Standard of Care|Subject will receive standard of care recommendations for healthy diet and lifestyle
15921146|NCT03489096|Device|Cryoballoon Ablation: PVI + substrate modification|Standard pulmonary vein isolation using cryoballoon ablation, followed by left atrial fibrosis substrate modification using cryoballoon ablation
15921147|NCT03489083|Other|Strength training|Strength training was performed three times per week for twelve weeks. Supervised (by qualified sport and exercise scientists) exercise was performed in a gym on three non-consecutive days of the week. Each session lasted ~60 min and consisted of a warm up, the resistance exercise training and a cool down. The training programme consisted of a combination of upper and lower body exercises using gym equipments, free weights and body weight as the primary resistance. The twelve weeks of strength training were divided into three mesocycles of four weeks each. The resistance training was performed using two to three sets per exercise at intensities between 12-15 repetition maximum-RM.
15921148|NCT03489083|Other|No Training|"Control group performed a placebo stretching/relaxing session once a week (for adherence purposes) for twelve weeks. To avoid any significant adaptation, all stretching exercises (for large muscle groups only) were performed at very low intensity without any significant discomfort."
15921149|NCT03489070|Combination Product|Traumastem®|Intraoperative application as secondary hemostatic treatment
15921150|NCT03489070|Combination Product|Surgicel®|Intraoperative application as secondary hemostatic treatment
15921151|NCT03489057|Behavioral|Prostate Cancer Education and Resources for Couples (PERC)|PERC uses mHealth technologies to dramatically increase couples' accessibility to posttreatment supportive care whenever and wherever they feel comfortable accessing it. PERC aims to improve QOL for both patients and partners by enhancing positive appraisals of illness and boosting self-efficacy, social support from multiple sources, and healthy behaviors for symptom self-management at home.
15921152|NCT03489057|Behavioral|usual care plus NCI website|The usual care plus NCI website provides generic information about prostate cancer treatment options, research, causes, and statistics; coping resources that are not prostate cancer-specific; support from non-providers via a toll free phone and LiveHelp Online Chat about cancer-related questions, clinical trials, and quitting smoking.
15921153|NCT03489044|Drug|Levetiracetam|To up-titrate Levetiracetam to 500mg (two tablets) twice daily followed by maintenance on Levetiracetam 500mg twice daily for four weeks and then down-titrate to nil over four weeks
15921154|NCT03489044|Drug|Placebo Oral Tablet|To up-titrate placebo to two tablets twice daily followed by maintenance on placebo two tablets twice daily for four weeks and then down-titrate to nil over four weeks
15921155|NCT03489005|Drug|BIA 5-1058|"Subjects will receive BIA 5-1058 tablets (containing 100 mg) as single, oral doses 30 minutes after the start of a moderate mealas follows:
~400 mg BIA 5 1058, as 4 × 100 mg tablets and 8 placebo tablets
~1200 mg BIA 5 1058, as 12 × 100 mg tablets"
15921156|NCT03489005|Drug|Placebo Oral Tablet|"Matching placebo tablets administered as follows:
~- placebo, as 12 × 0-mg tablets"
15921157|NCT03489005|Drug|Moxifloxacin 400 mg|"Administered as follows:
~- 400 mg moxifloxacin, as 1 × 400-mg tablet"
15921158|NCT03488992|Dietary Supplement|MVM/phytochemical supplement|Consumption of an MVM/phytochemical supplement for 8 weeks
15921159|NCT03488992|Dietary Supplement|Placebo|Consumption of a placebo tablet identical in size, shape and color to the treatment tablet
15921160|NCT03488979|Other|educational interventional group|• Patient Education Tool (Appendix 3) and the patient's own IVC images will be shared with each patient in the intervention group in real time. If feasible, each intervention patient will also receive a printed copy of his or her IVC image.
15921161|NCT03488966|Behavioral|Mindfulness Based Eating and Awareness Training|Eight sessions of Mindfulness Based Eating and Awareness Training (MB-EAT) will be delivered once per week over the course of 8 weeks, following an introductory session. The treatment uses general mindfulness meditation and eating meditation to help participants bring greater awareness and understanding to their relationship with food. Homework consists of weekly mindfulness exercises.
15921162|NCT03488953|Procedure|Living donor liver transplantation with two-staged hepatectomy.|Two-stage hepatectomy combined with transplantation of left-lateral lobe from a living donor.
15921188|NCT03488719|Drug|Metoprolol Succinate 100 MG|Metoprolol 100mg
15921189|NCT03488693|Radiation|Radiation|Radiotherapy given
15921163|NCT03488940|Device|24-hours group|"Daily amount of feeding were continuously pumped for 24 hours. Enteral nutrition preparations pumping scheme: the initial pumping speed is 40ml/h, and gastric residual volumes(GRV) is checked every 4 hours. If it can be tolerated, the velocity of the pumping can be increased by half of the original speed.If it is not tolerable, the speed of the pumping is reduced by half on the original speed.
~GRV<200 mL were considered markers of good tolerance. Feeding intolerance was defined as GRV>200 mL.
~Enteral nutrition preparation are Enteral Nutritional Suspension(TPF-FOS) which were producted by ABBOTT LABORATORIES B.V.. The feeding pump are Infusion pump P-600 which were producted by Atom Medical Corporation."
15921164|NCT03488940|Device|16-hours group|"Daily amount of feeding were continuously pumped for 24 hours.Enteral nutrition preparations pumping scheme: the initial pumping speed is 40ml/h, and gastric residual volumes is checked every 4 hours. If it can be tolerated, the velocity of the pumping can be increased by half of the original speed.If it is not tolerable, the speed of the pumping is reduced by half on the original speed.
~GRV<200 mL were considered markers of good tolerance. Feeding intolerance was defined as GRV>200 mL.
~Enteral nutrition preparation are Enteral Nutritional Suspension(TPF-FOS) which were producted by ABBOTT LABORATORIES B.V.. The feeding pump are Infusion pump P-600 which were producted by Atom Medical Corporation."
15921165|NCT03488940|Device|intermittent group|"Daily amount of feeding were divided into four meals, each meal are pumped within 60mins through stomach tube.
~Enteral nutrition preparations pumping scheme: the initial pumping speed is 200ml/h, and gastric residual volumes is checked before each intermittent feeding. If it can be tolerated, the velocity of the pumping can be increased by half of the original speed.If it is not tolerable, the speed of the pumping is reduced by half on the original speed.
~GRV<200 mL were considered markers of good tolerance. Feeding intolerance was defined as GRV>200 mL.
~Enteral nutrition preparation are Enteral Nutritional Suspension(TPF-FOS) which were producted by ABBOTT LABORATORIES B.V.. The feeding pump are Infusion pump P-600 which were producted by Atom Medical Corporation."
15921166|NCT03488927|Behavioral|Supporting Survivors and Self: An Intervention for Social Supports of Survivors of Partner Abuse and Sexual Aggression (SSS)|The SSS intervention consists of a two-hour session followed by a 90-minute booster session a month following the initial program session. The SSS intervention is delivered in groups of approximately 20 students facilitated by peer educators. The SSS intervention provides participants with specific information on the reasons why positive social reactions are important and negative social reactions can be harmful, examples of what to say and what not to say (including ways to promote healthy coping and discourage unhealthy coping, e.g., drinking to cope), opportunities for roleplay, and an emphasis on the importance of self-care and ways in which self-care can be balanced with the needs of IPV and SA victims.
15921167|NCT03488914|Behavioral|YMHP Intervention|
15921168|NCT03488914|Behavioral|Enhanced Treatment as Usual|
15921169|NCT03488901|Other|chemoresistance signature|to study the predictive value of a tissue transcriptomic profile (=chemoresistance signature) in the chemoresistance to single or multiagent chemotherapy
15921170|NCT03488888|Drug|Normal Saline 0,9%|Ultrasound-guided PEC II block with 30 mL of Normal Saline 0,9%
15921171|NCT03488888|Drug|Bupivacaine|Ultrasound-Guided PEC block with 30 mL of 0.25% bupivacaine solution
15921172|NCT03488875|Behavioral|mMBRT|Madison Mindfulness-Based Resilience Training (mMBRT) is an 8-week mindfulness-based intervention developed specifically for police officers, which is similar to and inspired by a program developed by researchers at Pacific (OR) University (Christopher, Goerling et al., 2016). mMBRT includes 8 weekly 2-hour classes involving guided meditation practice, gentle movement, and group-based discussion (the 7th class is a longer, 4-hour class). The total class time is about 18 hours over 8 weeks, and participants are asked to engage in home practice for up to 30 minutes/day, 6 days/week throughout the intervention.
15921173|NCT03488836|Procedure|reciproc|rotary reciprocating protocol
15921174|NCT03488836|Procedure|race rotary|race rotary group protocol
15921175|NCT03488823|Dietary Supplement|with Flavanol|Patient will get twice daily drink rich on flavanols (400 mg) since one week before catheterization till one week after catheterization.
15921176|NCT03488823|Dietary Supplement|without Flavanol|Patient will get twice daily drink without flavanols since one week before catheterization till one week after catheterization.
15921177|NCT03488810|Other|Radiation Therapy|Dose escalated Intensity-Modulated Radiation therapy (IMRT) with conventional fractionation, hypofractionation and prostate brachytherapy are allowed.
15921178|NCT03488810|Drug|Apalutamide|240 mg PO daily, started the same day as the first LHRHa injection, for 6 months
15921179|NCT03488810|Drug|Luteinising Hormone Releasing Hormone analog agonist (LHRHa)|2 injections of a three-monthly LHRH agonist depot
15921180|NCT03488810|Drug|Non-steroidal anti-androgen|Non-steroidal anti-androgen (e. g. flutamide, bicalutamide) PO daily for 4 weeks, started 2 weeks before the first LHRH agonist injection
15921181|NCT03488797|Behavioral|Supervised web- and home-based exercise intervention|"The intervention group gets access to a training platform. Every week, 3 training videos of 20 minutes each will be released on that platform with the aim to perform those during the ongoing week.
~Each exercise session is arranged in a video session with child friendly instructions and executions for the different exercises. The videos serve as a virtual training partner and exercise will be performed simultaneously while watching the video
~The overall training volume is 72 session calculated from 3 sessions per week over a duration of 24 weeks (6 month)"
15921182|NCT03488758|Other|CMF|Taking a infant formula based on cow milk protein fractions, 4-5 feeds per day given by bottle, 180-210 ml/feed, total 800-900ml per day for one mounth
15921183|NCT03488758|Other|GMF|Taking a infant formula based on whole goat milk, 4-5 feeds per day given by bottle, 180-210 ml/feed, total 800-900ml per day for one mounth
15921184|NCT03488745|Behavioral|IntelliCare + Phone Coaching|IntelliCare is composed of 13 separate, native apps. Each app targets a specific aspect of mental health (e.g., reducing worry, increasing social support, tracking negative thoughts). The apps are available to the public in both Android and iPhone stores. Participants will be asked to try two new IntelliCare apps every week, for 7 weeks. Phone coaching will occur at Day 0, before using any of the apps, and the third week of app usage.
15921185|NCT03488732|Device|Transcatheter valvular repair or replacement|Transcatheter valvular repair (predominantly MitraClip for mitral regurgitation) or replacement (predominantly transcatheter aortic valve implantation for aortic stenosis)
15921186|NCT03488719|Drug|Metoprolol Succinate 25 MG|Metoprolol 25mg
15921187|NCT03488719|Drug|Metoprolol Succinate 50 MG|Metoprolol 50mg
15921194|NCT03488654|Diagnostic Test|Cardiovascular magnetic resonance|CMR including cine, late gadolinium enhancement (LGE) and stress perfusion sequences
15921195|NCT03488641|Diagnostic Test|ex-vivo drug response assay|drug sensitivity testing of primary patient derived cancer cells
15921198|NCT03488602|Behavioral|F-SPS+UC|"Manualized individual and family program. Weekly individual and family sessions with a therapist for 6 weeks.
~Participants will continue to receive usual care."
15921199|NCT03488602|Behavioral|EUC|"Weekly telephone contact with parents regarding participant health care utilization. Referrals to community mental health resources provided as needed.
~Participants will continue to receive usual care."
15921200|NCT03488589|Diagnostic Test|serum samples for HEV RNA PCR|serum samples HEV RNA PCR
15921201|NCT03488576|Procedure|Complete Macular Peeling|A complete peeling of the internal limiting membrane was performed
15921202|NCT03488576|Procedure|Macular Peeling with Foveal Sparing|A partial peeling of the internal limiting membrane was performed, sparing the fovea.
15921203|NCT03488563|Biological|B244|B244 Suspension
15921204|NCT03488563|Biological|Vehicle|Vehicle Suspension
15921205|NCT03488550|Biological|ANX007|Single ascending dose
15921206|NCT03488537|Device|AeonoseTM|Breath test
15921207|NCT03488524|Drug|AMX0035|A combination therapeutic of TUDCA and Sodium Phenylbutyrate
15921208|NCT03488511|Other|FoodforCare at home|Six small protein rich meals that will be delivered twice a week for 3 weeks.
15921209|NCT03488498|Other|questionnaires|Examination of the spinal mobilization in cm. The pain and quality of life assessment of functional status through questionnaires.
15921210|NCT03488485|Drug|Direct Acting Antivirals|DAAs given in patients with viremic chronic hepatitis C
15921211|NCT03488472|Device|NovoTTF-200A|Begins within 7 days of SRS and continues until progression, death, or unacceptable toxicity.
15921212|NCT03488472|Radiation|Stereotactic Radiosurgery (SRS)|SRS will begin within 21 days of study enrollment for 5-6 Gy per fraction for a total of 25 or 30 Gy.
15921213|NCT03488459|Behavioral|Routine preoperative information from a nurse|Routine preoperative information from a nurse.
15921214|NCT03488459|Behavioral|Additional information support from a psychologist|Routine preoperative information from a nurse + additional information support from a psychologist.
15921215|NCT03488433|Device|Abduction brace|Donjoy Ultrasling IV
15921216|NCT03488433|Device|Antirotation sling|Donjoy shoulder immobilizer
15921217|NCT03488420|Drug|Edoxaban Pill|Subjects will be taking edoxaban 30 or 60 mg
15921218|NCT03488394|Genetic|Frozen autologous CD34+ hematopoietic stem and progenitor cells genetically modified with the lentiviral vector IDUA LV, encoding for the α-L-iduronidase cDNA, in their final formulation medium.|"The drug product target dose is more or equal to 8x10^6 CD34+ cells/Kg, with a minimum dose of 4x10^6 CD34+ cells/Kg and a maximum dose of 35x10^6 CD34+ cells/Kg.
~The product will be injected intravenously."
15921219|NCT03488381|Device|Soccer Heading|"Soccer Heading: Subjects stood approximately 40 feet away from a JUGS soccer ball launcher and participated in 10 consecutive soccer headings, separated by one minute intervals.
~Soccer Kicking: Subjects stood approximately 40 feet away from a JUGS soccer ball launcher and participated in 10 consecutive soccer kicks, separated by one minute intervals."
15921220|NCT03488368|Other|observation|Observation of renal outcome parameters and adverse events in the follow-up beyond the 3-year trial phase of the original STOP-IgAN trial.
15921221|NCT03488355|Other|Modified laboratory report|"Report from microbiology laboratory: This POSITIVE urine culture collected from an indwelling catheter may represent asymptomatic bacteriuria or urinary tract infection. If urinary tract infection is suspected clinically, please call the microbiology laboratory for identification and susceptibility results."
15921222|NCT03488342|Procedure|Repair for primary inguinal hernia|Repair for primary inguinal hernia
15921223|NCT03488329|Dietary Supplement|Individual nutritional therapy|"Guidance from a clinical dietician.
~Individual nutrition plan
~A package containing foods and drinks, which will cover their nutritional needs the first day after discharge.
~A goodiebag containing samples on protein-rich milk-based drinks.
~Telephone follow-up after 4 and 30 days and the possibility to call the dietician in case of questions about nutrition."
15921224|NCT03488316|Procedure|Carie removal|Carie removal with a low speed handpiece
15921225|NCT03488316|Procedure|Absolute isolation|Absolute isolation with rubber dam
15921226|NCT03488316|Drug|Manipulation of the temporary filling material based on Calcium Hydroxide|Manipulation of the temporary material based on Calcium Hydroxide according to the manufacturer's recommendations.
15921227|NCT03488316|Drug|Manipulation of the temporary filling material based on Mineral trioxide aggregate|Manipulation of the temporary material based on Mineral trioxide aggregate according to the manufacturer's recommendations.
15921228|NCT03488316|Procedure|Material insertion on the root canal|Material insertion on the root canal according to the manufacturer's recommendations
15921229|NCT03488316|Procedure|Material re-insertion on the root canal accordging to the infection needs.|Material re-insertion on the root canal according to the manufacturer's recommendations
15921230|NCT03488316|Procedure|Definiteve canal root obturation|Definiteve canal root obturation with gutta-percha and definitive cement.
15921231|NCT03488316|Procedure|Definitve restoration|Definitve restoration confecction.
15921232|NCT03488290|Behavioral|LTP Plus TF-CBT|Experimental: LTP Plus TF-CBT LTP Plus TF-CBT group participants will receive group intervention by masters' level trained facilitators weekly during the first two months and then fortnightly. It comprises of two components i.e. LTP and TF CBT. LTP aims at enabling parents to improve their child's psychosocial development by educating about child development and the importance of mother-child play. TF CBT aim is to modify excessively negative appraisals of the trauma and its sequelae by careful questioning
15921233|NCT03488290|Other|Treatment as Usual|The Treatment as Usual group will receive routine care
15921234|NCT03488277|Other|leg elevation|intra operative position that consists in leg elevation with a 30 cm height pillow under the patient's heels
15921236|NCT03488238|Device|ORi sensor|Noninvasive pulse oximeter sensor that is placed on the finger for measurement of ORi
15921237|NCT03488225|Drug|Cyclophosphamide|Given IV
15921238|NCT03488225|Drug|Cytarabine|Given IT or IV
15921239|NCT03488225|Drug|Dexamethasone|Given IV or PO
15921240|NCT03488225|Drug|Doxorubicin Hydrochloride|Given IV
15921241|NCT03488225|Biological|Inotuzumab Ozogamicin|Given IV
15921242|NCT03488225|Other|Laboratory Biomarker Analysis|Correlative studies
15921243|NCT03488225|Drug|Leucovorin Calcium|Given IV
15921244|NCT03488225|Drug|Mercaptopurine|Given PO
15921245|NCT03488225|Drug|Methotrexate|Given IT, IV or PO
15921246|NCT03488225|Biological|Ofatumumab|Given IV
15921247|NCT03488225|Drug|Prednisone|Given PO
15921248|NCT03488225|Biological|Rituximab|Given IV
15921249|NCT03488225|Drug|Vincristine Sulfate|Given IV
15921250|NCT03488212|Behavioral|Training to Identify Eligible Patients and Direct them to Online Obesity Treatment Program|Primary care clinic staff are trained to identify patients who meet study inclusion and exclusion criteria. They are then trained to provide patients with the information necessary to enroll in the study and access the online behavioral obesity treatment.
15921251|NCT03488212|Behavioral|Training to Motivate and Support Patients' Weight Loss|Primary care clinic staff are trained in psychological and behavioral strategies for: talking to patients about weight and weight loss in a way that patients find acceptable and helpful, increasing motivation for weight loss, overcoming common barriers to weight loss, and persevering with a weight loss attempt. They are trained in strategies to provide this support by telephone in addition to during clinic visits.
15921252|NCT03488212|Behavioral|Online Behavioral Weight Loss Intervention|For 3 months, participants receive: a weekly online lessons for training in behavioral skills for losing weight; online self-monitoring of daily weight, diet, and physical activity; weekly feedback on the self-monitoring record.
15921253|NCT03488212|Behavioral|Control Intervention for Weight Loss Maintenance and Weight Gain Prevention|After completing the 3-month Online Behavioral Weight Loss Intervention, participants receive 9 months of: monthly online newsletters with educational information pertaining to healthy weight, diet, and physical activity habits.
15921254|NCT03488212|Behavioral|Monthly Lessons and Feedback Intervention for Weight Loss Maintenance and Weight Gain Prevention|After completing the 3-month Online Behavioral Weight Loss Intervention, participants receive 9 months of: monthly online lessons for training in behavioral skills for maintaining weight loss and preventing weight gain; online self-monitoring of daily weight, diet, and physical activity; monthly feedback on the self-monitoring record.
15921255|NCT03488212|Behavioral|Refresher Courses for Weight Loss Maintenance and Weight Gain Prevention|After completing the 3-month Online Behavioral Weight Loss Intervention, participants receive two month-long refresher courses with weekly online lessons for training in behavioral skills for maintaining weight loss and preventing weight gain; online self-monitoring of daily weight, diet, and physical activity; weekly feedback on the self-monitoring record; weekly challenges focuses on specific behavior change and weight loss goals.
15921256|NCT03488199|Device|Stent Acculink ™|Carotid Artery Revascularization using Stents
15921257|NCT03488199|Device|CGuardTM™|Carotid Artery Revascularization using Stents
15921258|NCT03488186|Drug|Lansoprazole Capsules|24 healthy volunteers will be recruited and randomized into 2 groups (12 for each). During the study session, subjects will receive T drug in group A or R drug in group B for 7 days in fasted condition.
15921259|NCT03488173|Drug|Lansoprazole capsules|"Test 1: 30 healthy volunteers will be included and randomized into 3 groups (10 for each). During the study session, subjects will receive a single dose of Lansoprazole capsules 30 mg in sequence of T-R-R in group A; R-T-R in group B; and R-R-T in group C.
~Test 2: 12 healthy volunteers will be recruited and randomized to 2 groups (6 for each). Subjects in group A will receive a single dose of experimental drug in sequence of fast-fed condition; while in group B, subjects will receive the same dose and drug but in fed-fast order."
15921260|NCT03488160|Biological|CD19-targeted CAR-T cells|This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-CD19-modified T cells can recognize and kill tumor cells in the body，follow-up 35 months..
15921261|NCT03488147|Drug|Esomeprazole|20 mg esomeprazole tablet
15921262|NCT03488147|Drug|Placebo Oral Tablet|resembling esomeprazole tablet
15921263|NCT03488121|Behavioral|Poster|Posters contain inspirational messages and pictures highlighting the important and unique roles that patients and physicians can play in reducing unnecessary care and health care costs. These posters will be placed in physician offices.
15921264|NCT03488121|Behavioral|Thank-you Letter|Physicians will be sent thank-you letters containing changes in the rates of antibiotics and serum ferritin tests ordered since introduction of Choosing Wisely NL and a thank-you message from the NL Medical Association.
15921265|NCT03488108|Other|Platelet Rich Plasma|Autologous Platelet Rich Plasma (PRP) will be isolated from blood collected from each subject at each treatment time point. 100 cc of PRP will be injected with a 30-gauge needle over the affected part of the scalp, approximately 1/10 cc/injection site. Treatments will take place every 4 weeks for a total of 3 treatments over 12 weeks.
15921266|NCT03488108|Drug|Minoxidil Foam|Minoxidil 5% topical foam will be applied once daily following manufacturer's instructions for a total of 12 weeks.
15921267|NCT03488095|Behavioral|BCI for SLT and BQ Use in Adolescents: A CRT|BCI for SLT and BQ Use in Adolescents: A CRT is aimed towards changing Adolescenst behaviors regarding their SLT and BQ use to as to reduce Oral cancer Burden within population because of this.
15921268|NCT03488082|Behavioral|fMRI|saccadic adaptation (target presentations, with or without target jump) during fMRI exam
15921269|NCT03488069|Other|Survey|Submission of survey answers
15921296|NCT03487796|Other|Waitlist Control|Youth and parents will not receive intervention materials for the first four months of participation. At the completion of the 4-month follow-up assessment, youth and parents will be eligible to receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication.
15949168|NCT03271047|Drug|nivolumab|Intravenously (IV) every 4 weeks (Q4W)
15921270|NCT03488056|Other|ICCMS|"The patient's caries risk assessment, Diagnosis of caries lesion and activity assessment
~-Intraoral risk assessment, Decide on a personalized care plan for patient and clinical interventions.
~After asses all the factors and defining the patient's individual risk, the system presents a personalized treatment plan, indicating the appropriate home care instructions, clinical interventions and specific treatment for each caries lesion categories.
~The treatment is divided into Non-Operative Care and Tooth-Preserving Operative Care (restorations with minimal intervention to preserve maximum dental structure).
~The return intervals will be scheduled according to the risk: low risk (return of 1 year), moderate risk (6 months) and high risk (3 months)"
15921271|NCT03488056|Other|SESC standard care|Standard care related to: Caries Diagnosis, operative and non-operative treatments, Indication of recall interval according to the dentist opinion
15921272|NCT03488043|Procedure|Needle lung biopsy|Needle lung biopsy
15921273|NCT03488017|Device|Ocular Coil|Non-invasive ocular device
15921274|NCT03487991|Behavioral|Personalized sleep intervention|Personalized feedback and recommendations based on study observations of sleep behavior and how participants cope with potentially sleep disruptive cognitions on their frequency and impact and on sleep efficiency. A written report is provided to participants and their initial modifications are monitored.
15921275|NCT03487978|Diagnostic Test|resting-state functional MRI|"To ensure inter-ictal fMRI, confirm that the subject has no migraine for at least 48 hours before the procedure.
~Record the time difference between the date on the day of fMRI and the date of the last headache attack and record whether the headache on the day of fMRI is absent or not.
~On the third day after MRI, examine whether the subject has headache or not."
15921276|NCT03487965|Dietary Supplement|Low dose Polyphenol|botanical supplement with 25 mg polyphenol
15921277|NCT03487965|Dietary Supplement|High dose Polyphenol|botanical supplement with 13 mg polyphenol
15921278|NCT03487965|Dietary Supplement|Placebo Control|inert tablet made to mimic the experimental tablets
15921279|NCT03487952|Other|Questionnaire Administration|Subjects will be asked to complete an additional detailed questionnaire regarding personal information, smoking history, medical history, their diet and lifestyle habits, family history of malignant neoplasm, any past or current environmental exposures and psychological status.
15921280|NCT03487939|Drug|FOLFOXIRI|IRINOTECAN 150 mg/m^2 IV over 1-h, day 1 + OXALIPLATIN 85 mg/m^2 IV over 2-h, day 1 + L-LEUCOVORIN 200 mg/m^2 IV over 2-h, day 1 + 5-FLUOROURACIL 2800 mg/m^2 IV 48-h continuous infusion, starting on day 1 administered every two weeks for 4 cycles (2 months).
15921281|NCT03487926|Radiation|[18F]FEPPA|up to 3 PET Scans ([18F]FEPPA PET scans done 3 to 6 months apart, and one [11C]SL2511.88 PET scan) and 1 MRI
15921282|NCT03487913|Drug|Lixivaptan|Oral vasopressin V2 receptor antagonist
15921283|NCT03487900|Diagnostic Test|Colonoscopy|Colonoscopy for CD patients in clinical remission
15921284|NCT03487887|Device|continuous glucose monitoring (CGM) iPro™2 Medtronic|A CGM device is to be set and take off by the diabetologist. Before the study start all diabetologist not familiar to the method will have a short education on CGM device. Study period is seven days and includes screening before study entry and two visits. On Day 1, after screening and signing the informed consent, the CGM device is applied. Patient is instructed to keep a 7 day diary with four daily standard SMBG along with the data on eating, physical exercise, drugs. On Day 7, CGM device is taken off and the data from iPro2 is uploaded to PC. At the end, each patient fills a short query on satisfaction while wearing CGM.
15921285|NCT03487874|Procedure|Conventional interscalene block|Under ultrasound guidance, the 5th to 7th cervical nerve roots are blocked.
15921286|NCT03487874|Procedure|Interscalene block with C8 root block|Under ultrasound guidance, the 5th to 8th cervical nerve roots are blocked.
15921287|NCT03487874|Drug|0.75% ropivacaine|Placement of 25 to 30 ml of 0.75% ropivacaine around the cervical nerve roots
15921288|NCT03487861|Diagnostic Test|observational(urinary biomarker for kidney allograft fibrosis)|After an informed consent is obtained, urine specimens will be collected prospectively before kidney transplantation (if available) and 3rd and 7th day, 1st, 3rd, and 6th month post-transplant. About 35~50ml of urine sample is collected from each patient. For each urine specimen, 0.5 ml of a protease inhibitor mixture (5mM 4-(2-animoethyl) benzensulfonyl fluoride hydrolchloride, 2 μM Leupeptin-hemisulfate, and 3.3 mM Sodium azide) is added. To remove urinary sediments including whole cells, large membrane particles, and other debris, urine specimens are centrifuged at a rate of 4000 rpm for 15 minutes at 4 ℃. An aliquot of supernatant is stored at -80 ℃ until use. Urinary biomarkers including transglutaminase 2 are quantified using ELISA or CBA. In addition, urinary exosomes are isolated and analyzed. When a for-cause biopsy is done for some patients, the correlation between biomarkers and pathologic diagnosis will be assessed.
15921289|NCT03487848|Drug|Daclatasvir|Specified dose on specified days for specified duration
15921290|NCT03487848|Drug|Sofosbuvir|Specified dose on specified days for specified duration
15921291|NCT03487835|Other|Kinesiotape|
15921292|NCT03487835|Other|No application|This group have no application during study time
15921293|NCT03487822|Behavioral|Path Pain|The intervention examines the effects of PATH-Pain on emotion regulation to improve self-management of pain and pain-related disability in older adults with chronic pain, negative emotions, and cognitive impairment. This intervention consists of 8 weekly therapy sessions by a licensed clinician trained in Path Pain, 4 monthly boosters upon completion of therapy, and optional monthly group educational sessions.
15921294|NCT03487809|Drug|Budesonide/Cisclesonide|One arm observation study: Duasma 1 puff bid (Budesonide 200mcg bid) or Alvesco 1 puff qd (Ciclesonide 160mcg qd) for participants aged 11 years and younger, Duasma 2 puffs bid (Budesonide 400mcg bid) or Alvesco 1 puff bid(Ciclesonide 160mcg bid) for participants aged 12 years and older
15921295|NCT03487796|Behavioral|MySTYLE|Youth and parents will receive two secure texts or emails to their cell phone or preferred device weekly (for eight weeks). Each text/email will contain a link to new media content designed to (1) improve sexual health knowledge surrounding HIV/AIDs and sexually transmitted infections, (2) increase acceptance of young Black men of all backgrounds (sexual, economic, and family), and (3) improve parent and adolescent relationships and communication.
15921297|NCT03487783|Drug|Aripiprazole Oral Solution|Aripiprazole 2-20 mg/day (2-20 mL/day)
15921298|NCT03487783|Drug|Placebo Oral Solution|Placebo 2-20 mg/day (2-20 mL/day)
15921299|NCT03487770|Drug|Aripiprazole Oral Solution|Aripiprazole 2~15 mg/day (2~15 mL/day)
15921300|NCT03487770|Drug|Placebo Oral Solution|Placebo 2~15 mg/day (2~15 mL/day)
15921301|NCT03487757|Other|Core Stabilization Exercises|Jeffrey's core stabilization exercise training protocol will be performed to the training group. This protocol includes exercises progressing gradually from level 1 to level 3. Level 1; static contraction training on a stable surface, level 2; dynamic training on a stable surface, level 3; dynamic and resistant training on an unstable surface.
15921302|NCT03487757|Other|No Intervention|Since no training is given to the control group during the study period, it is ethically necessary to give the same training to the control group if the benefit is achieved when the study is completed.
15921303|NCT03487744|Other|Osmolite 1.5|Continuous enteral tube feeding according to a standardized calculation via nasojejunal tube.
15921304|NCT03487744|Other|Promote without fiber|Continuous enteral tube feeding according to a standardized calculation via nasojejunal tube.
15921305|NCT03487731|Biological|Allogeneic Human Mesenchymal Stem Cells (hMSCs)|A single administration of 20 million allogeneic mesenchymal stem cell delivered intra-facet via 6 injections of 1.5 mL per injection, total of 9 to 12ml.
15921306|NCT03487731|Drug|Placebo|A single administration of 1 cc of 1% lidocaine with 1 cc of 2% Ropivicaine and 0.5 cc of betamethasone soluspan (celestone) solution delivered via intra-facet injection.
15921307|NCT03487718|Biological|Leukocyte platelet rich fibrin plug + d-PTFE membrane|Following tooth extraction, an autologous leukocyte platelet rich fibrin plug will be placed in the socket and covered with a d-PTFE membrane
15921308|NCT03487718|Device|d-PTFE membrane|Following tooth extraction, the socket will be covered with a d-PTFE membrane
15921309|NCT03487705|Other|electromyographic essential tremor|"Making a recording electromyographic recording of the essential tremors in each child included at prospective.
~Collect an electromyographic recording of essential tremors already made in each child included at retrospective."
15921310|NCT03487692|Other|Diabetes MESSAGES Program|Health centers in the 2018 Training Cohort will enroll groups of 10-15 patients to attend 6 monthly diabetes group visits consisting of group education, social support, goal setting, and an individual medical visit for each patient. At the same time, patients will be enrolled in a 6-month interactive diabetes text messaging program. Patients will receive quarterly booster sessions for 1-2 years after the 6-month intervention period.
15921311|NCT03487692|Other|Diabetes MESSAGES Program (second trial)|During the first trial period, health centers in the 2020 Training Cohort will collect data on patients receiving usual care. After the first trial period, health centers in the 2020 Training Cohort will enroll groups of 10-15 patients to attend 6 monthly diabetes group visits consisting of group education, social support, goal setting, and an individual medical visit for each patient. At the same time, patients will be enrolled in a 6-month interactive diabetes text messaging program. Patients will receive quarterly booster sessions for 1-2 years after the 6-month intervention period.
15921312|NCT03487679|Other|Fasting|Participants will undergo one day of habitual eating followed by 36 hours of water-only fasting and final day of habitual eating consuming the exact same diet consumed on the first eating day. Blood draws will be performed on Day 1 in a 10-12 hr fasted state and 2 hour postprandial state and again on Day 3 in a 36hr fasted state and a 2 hour post prandial state. Microbiome samples and blood glucose data will be collected throughout the course of the study.
15921313|NCT03487666|Drug|Nivolumab|Nivolumab is a human programmed death receptor-1 (PD-1) antibody currently approved in different diseases.
15921314|NCT03487666|Drug|Capecitabine|Capecitabine was selected for Arm B given the recent results from CREATE-X trial and the increasing use by the community (feasibility). Importantly, available data from other scenarios indicates that capecitabine does not have immunosuppressive effects
15921315|NCT03487653|Biological|microbiology:Blood culture and sensitvity test .Serology|Gram stain ,Blood culture ,sensitivity test ,biochemical reactions and serological study will be done
15921316|NCT03487640|Procedure|TARMR|Transanal resection of rectal mucosa for at least 5cm in length.
15921317|NCT03487640|Procedure|LARSC|We are going to suspend the rectum and to resect rigmarole hidgut Laparoscopically
15921318|NCT03487627|Behavioral|Electronic and Care Support Manager Contact|This intervention will consist of electronic and Care Support Manager (CSM) contacts with parents from the first week following their adolescent's discharge from hospitalization through the first 3 months after discharge. The electronic application content will be accessible and delivered to parents weekly. Parents will also be able to enter a keyword on their electronic device to access content and material in real time. The CSM contacts will supplement the informational content delivered electronically by providing opportunities to ask questions about the electronic application material, and by checking on progress toward treatment follow through for their youth, identifying and problem solving any difficulties and concerns, and addressing health needs of each parent.
15921319|NCT03487627|Behavioral|Enhanced Treatment-as-usual (TAU)|TAU typically involves a discharge planning session by unit staff with the adolescent and their parent(s) to discuss safety monitoring and referrals for mental health services following discharge from psychiatric hospitalization. Investigators will augment this usual care by providing written materials to families outlining some of the key considerations for caring for their adolescent. These written materials will include brochures with information for parents following adolescent suicidal behavior, a listing of resources including instructions for when to call 911 or go to the emergency room, and information regarding the National Suicide Prevention Lifeline. Written materials will be provided to both the enhanced TAU participants as well as participants receiving the electronic and CSM intervention.
15921320|NCT03487614|Behavioral|Behavior-based parental intervention|Behavioral intervention designed to promote healthy feeding behaviors in parents of 2-5 year olds, and to modify parenting practices in a way that encourages adequate physical activity, sufficient sleep, and healthy nutrition, while limiting sedentary behaviors.
15921321|NCT03487601|Other|transcranial direct current stimulation|Active treatment will consist of a mild electrical current (2mA) administered via saline-soaked sponge electrodes placed along the intact scalp for 30 minutes a day for five days.
15921322|NCT03487601|Other|sham transcranial direct current stimulation|Sham stimulation will involve brief delivery of current in a manner that does not result in changes in neuronal firing patterns, but that is perceived as active treatment by participants.
15921323|NCT03487588|Drug|A-101 Topical Solution|A-101 Topical Solution applied Day 1, Day 15 and Day 29
15921325|NCT03487562|Drug|DWP14012 Amg|DWP14012 Amg
15921326|NCT03487562|Drug|DWP14012 Bmg|DWP14012 Bmg
15921330|NCT03487549|Combination Product|VP-102 Cantharidin topical film forming solution|VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). Treatment interval of at least 14 days between treatments.
15921331|NCT03487549|Combination Product|VP-102 Cantharidin, topical film forming solution|VP-102, a single-use drug device combination product containing (cantharidin) topical solution, 0.7% (w/v). Treatment interval of at least 21 days between treatments.
15921332|NCT03487536|Other|Nutritional assessment|BMI and cholesterol levels evaluation
15921333|NCT03487523|Behavioral|Text Message|As already stated
15921334|NCT03487510|Other|NO interventions apply|does not apply
15921335|NCT03487497|Procedure|Lateral column lengthening osteotomy|Lengthening osteotomy of the lateral column of the foot
15921336|NCT03487484|Behavioral|Quality of Life Questionnaire for gastrointestinal tract|To assess quality of life, the GIQLI questionnaire (Gastrointestinal Quality of Life Index) will be applied
15921337|NCT03487484|Behavioral|Quality of Life Questionnaire|To assess quality of life, the SF-36 questionnaire will be applied
15921338|NCT03487484|Behavioral|Faecal Incontinence Score|To assess faecal incontinence, the Vaizey Wexner questionnaire will be applied
15921339|NCT03487471|Diagnostic Test|Real-time elastography|Breast ultrasound with real-time elastography
15921340|NCT03487471|Diagnostic Test|Shear wave elastography|Breast ultrasound with shear wave elastography
15921341|NCT03487458|Procedure|Rib Fixation Surgery|Rib Fixation Surgery
15921342|NCT03487445|Drug|Selatogrel 8 mg|Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. It is supplied in sealed glass vials at a strength of 20 mg. The vials with ACT-246475A (hydrochloride salt of ACT-246475) will be reconstituted with 1 mL of water and further diluted with 1 mL sodium chloride (NaCl) 0.9%.
15921343|NCT03487445|Drug|Selatogrel 16 mg|Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. It is supplied in sealed glass vials at a strength of 20 mg. The vials with ACT-246475A (hydrochloride salt of ACT-246475) will be reconstituted with 1 mL of water for injection.
15921344|NCT03487432|Device|Super High-Pressure NC PTCA Balloon (OPN NC)|Strategy of Super High-Pressure NC PTCA Balloon (OPN NC) after unsuccessful lesion preparation with conventional NC balloon angioplasty.
15921345|NCT03487432|Device|Scoring PTCA Balloon (NSE Alpha)|Strategy of Scoring PTCA Balloon (NSE Alpha) after unsuccessful lesion preparation with conventional NC balloon angioplasty.
15921346|NCT03487406|Drug|Ticagrelor|One 90 mg tablet, oral, twice daily for 6 months.
15921347|NCT03487406|Drug|Aspirin|One 75 mg tablet, oral, once a day, for 6 months.
15921348|NCT03487406|Drug|Placebo Aspirin|Sugar tablet to mimic Aspirin 75 mg tablet One 75 mg tablet, oral, once a day, for 6 months.
15921349|NCT03487406|Drug|Placebo Ticagrelor|Sugar tablet to mimic Ticagrelor 90 mg tablet. Once 90 mg tablet, oral, twice daily for 6 months.
15921350|NCT03487393|Device|magnetic facial nerve stimulation|Magnetic stimulation of facial nerve.
15921351|NCT03487380|Procedure|Fecal sample collection|Fecal sample collection
15921352|NCT03487354|Drug|Misoprostol|Misoprostol
15921353|NCT03487341|Other|Cord drainage|Cord drainage
15921354|NCT03487341|Other|Cord clamping|Cord clamping
15921355|NCT03487328|Procedure|Sacrospinous-Sacrotuberous fixation|Sacrospinous-Sacrotuberous fixation
15921356|NCT03487315|Diagnostic Test|immunoblot|immunoblot
15921357|NCT03487302|Other|Brain MRI|Acquisition of 3D T1-weighted, 3D FLAIR and GRE brain MRI scans
15921358|NCT03487302|Other|Neuropsychological test battery|"Mini Mental State Examination (MMSE), Measso et al. (1993);
~Frontal Assessment Battery (FAB), Appollonio et al. (2005);
~Symbol Digit Test, Amodio et al. (2002);
~Digit Cancellation Test, Della Sala et al. (1992);
~Trial Making Test (TMT A-B), Giovagnoli et al. (1996);
~Weigl's Sorting Test, Laicona et al. (2000) and Inzaghi (2010);
~Digit Span, Orsini et al (1987);
~Corsi block-tapping test, Orsini et al. (1987);
~Babcock story recall test, Carlesimo et al. (2002);
~Phonemic verbal fluency in MDB, Caltagirone and Carlesimo (2010);
~Semantic verbal fluency, Novelli (1986);
~Imitating gestures, De Renzi et al. (1980);
~Coloured Progressive Matrices (CPM47), Measso et al. (1993)."
15921359|NCT03487289|Procedure|natural orifice|laparoscopic right colon surgery and patients who are removed from the natural orifice and conventional will gather
15921360|NCT03487276|Drug|IFX-1|Single IV infusions of IFX-1 diluted in sodium chloride.
15921361|NCT03487276|Drug|Placebo|Placebo
15921362|NCT03487263|Biological|IC14|chimeric monoclonal antibody against human IC14
15921363|NCT03487250|Device|TenJet System|Percutaneous ultrasound guided medial and lateral tenotomy using the TenJet HydroSurgery System
15921364|NCT03487237|Biological|Ddimer testing|Included patients will undergo a formal work up for pulmonary embolism: Ddimer testing, followed if positive by a computed tomography pulmonary angiogram or V/Q scan.
15921365|NCT03487224|Device|MRI with fMRI frequency|Functional magnetic resonance imaging or fMRI measures brain activity by detecting changes in blood flow. Participants will do cognitive tasks during fMRI.
15921366|NCT03487211|Drug|Duloxetine|Duloxetine 30mg PO once daily for 1 week followed by an increase to 60mg PO once daily
15921367|NCT03487211|Drug|Escitalopram|Escitalopram 10mg PO once daily for 1 week followed by an increase to 20mg PO once daily
15921368|NCT03487198|Drug|Brexpiprazole|Brexpiprazole 2-3mg/day
15921369|NCT03487198|Drug|Placebo|Placebo 2-3 mg/day
15921370|NCT03487185|Device|Continuous Positive Airway Pressure|Autotitrating CPAP with weekly contact, incentives for compliance and initial sleep advice counseling
15921371|NCT03487185|Other|Sleep Advice Control|Initial sleep advice counseling alone
15921372|NCT03487172|Device|poly-L-lactic acid to right knee|Subjects will receive PLLA injections to the right knee and bacteriostatic water to the left.
15921373|NCT03487172|Device|poly-L-lactic acid to left knee|Subjects will receive PLLA injections to the left knee and bacteriostatic water to the right.
15921374|NCT03487159|Device|MRE (Magnetic Resonance Elastography)|The device is using to evaluate liver fibrosis stage
15921436|NCT03486704|Behavioral|FTF VRRS plus unstructured CS|"Face to Face cognitive training using VRRS plus at-home unstructured cognitive stimulation.
~Participants will receive 12 sessions of an individualized Face to Face (FTF) cognitive training using VRRS over 4 weeks followed by 36 sessions of home-based unstructured cognitive stimulation (CS), three sessions for week."
15921375|NCT03487146|Device|hemoperfusion(HP)|These patients were computer-matched into two groups, involving 100 patients with absolute HD vs. 100 cases with HD+HP.HP was performed 1-2 times/per 2 weeks, and each session lasted for two hours.Self-reported sleep disturbance was evaluated before and after observational time (two-year period), which lasted at least 7 hours based on the recommendations presented by National Institute of Health (NIH). Sleep efficiency (%) was calculated as the ratio of sleep duration to total time in bed, and was multiplied by 100.
15921376|NCT03487133|Drug|bortezomib/dexamethasone|"Induction therapy ->1cycle=28 days 1,2,3week : bortezomib 1.6 mg/m2 SC(subcutaneous), dexamethasone 40mg IV 4week : none maintenance therapy ->1cycle=28 days
~1week : bortezomib 1.6 mg/m2 SC(subcutaneous), dexamethasone 40mg IV 2,3,4week : none"
15921377|NCT03487120|Procedure|facet joint denervation|Bipolar electrocautery
15921378|NCT03487107|Drug|SOF|400 mg tablet administered orally once daily
15921379|NCT03487107|Drug|DAG181|100 mg capsule administered orally once daily
15921380|NCT03487094|Other|Infant formula|Multi-centered, prospective, randomized clinical trial
15921381|NCT03487081|Behavioral|Social regulation|Participants will be instructed to help another person think about their negative events differently using an emotion regulation strategy called reappraisal.
15921382|NCT03487081|Behavioral|Self regulation|Participants will be instructed to think about their negative events by reframing the meaning of the event. This is a typical strategy in emotion regulation research known as reappraisal.
15921383|NCT03487068|Device|The FibroScan device|The Fibroscan device (Echosens) works by measuring shear wave velocity. In this technique, a 50-MHz wave is passed into the liver from a small transducer on the end of an ultrasound probe. The probe also has a transducer on the end that can measure the velocity of the shear wave (in meters per second) as this wave passes through the liver. The shear wave velocity can then be converted into liver stiffness, which is expressed in kilopascals. Essentially, the technology measures the velocity of the sound wave passing through the liver and then converts that measurement into a liver stiffness measurement; the entire process is often referred to as liver ultrasonographic elastography.
15921384|NCT03487055|Biological|TK006|Subcutaneous injection in the upper arm
15921385|NCT03487042|Drug|Bimatoprost 0.03% ophthalmic solution|"Each patient will be subjected to the following:
~One side will be treated by narrow band ultraviolet rays B sessions twice weekly for 3 months + topical bimatoprost 0.03% solution twice daily ( 1 drop for each 2 cm2 ) and the other side will be treated by topical bimatoprost 0.03% twice daily ( 1 drop for each 2 cm2 ) + narrow band ultraviolet rays B sessions twice weekly for 3 months + 10.600-nm fractional carbon dioxide laser sessions twice monthly for 3 months.
~Patients' Evaluation:
~The recruited patients will be subjected to:
~A) Full history taking. B) General clinical examination. C) Dermatological examination of the skin lesions. D) Vitiligo area scoring index score will be calculated for each patient E) Clinical photographs will be taken at baseline, after each month during treatment and after the end of treatment by 3 months.
~F) A skin biopsy from the treated lesions for histochemical examination. F) Dermoscopic evaluation of the treated sites every 2 weeks."
15921386|NCT03487029|Other|Short duration|exercise Short duration high intensity training
15921387|NCT03487029|Other|Long duration|exercise Long duration high intensity training
15921388|NCT03487016|Drug|Gemcitabine|Arm A
15921389|NCT03487016|Drug|Nab-paclitaxel|Arm A
15921390|NCT03487016|Drug|5-FU|Arm B Arm C
15921391|NCT03487016|Drug|Irinotecan Liposomal Injection|Arm B Arm C
15921392|NCT03487016|Drug|Oxaliplatin|Arm C
15921393|NCT03487003|Drug|rocuronium|After standard anesthetic monitoring (non-invasive blood pressure monitor, pulse oximetry, 3-lead echocardiography), patients are inhaled with sevoflurane. When the patients asleep, 0.3 mg/kg rocuronium is administered. After 2 min, flexible laryngeal mask airway (fLMA) is inserted using standard method. The fLMA is inflated with air to 40 cmH2O using manometry. The oropharyngeal leak pressure (OLP) was determined by the method described by Lopez-Gil and colleagues.
15921394|NCT03487003|Drug|saline|After standard anesthetic monitoring (non-invasive blood pressure monitor, pulse oximetry, 3-lead echocardiography), patients are inhaled with sevoflurane. When the patients asleep, 0.3 mg/kg saline is administered. After 2 min, flexible laryngeal mask airway (fLMA) is inserted using standard method. The fLMA is inflated with air to 40 cmH2O using manometry. The oropharyngeal leak pressure (OLP) was determined by the method described by Lopez-Gil and colleagues
15921395|NCT03486990|Drug|TIMP-GLIA|intravenous infusion.
15921396|NCT03486977|Procedure|Evaluation of disease and follow-up|Correspondence medical consultation with specific device
15921397|NCT03486964|Drug|DPP-4 inhibitors|Patients will be retrospectively evaluated after the addition of a DPP-4 inhibitor to previously taken anti-diabetic therapy
15921398|NCT03486951|Procedure|Orthognathic Surgery:|maxillary/mandibular osteotomies for orthognathic purposes for the treatment of a dento-maxillary dysharmony The choice between outpatient procedure or hospitalization is decided by the surgeon on a case-by-case basis according to data relating to the general state of the patient, the type of surgery, the social context, the distance from the patient's home. a medical center in accordance with the usual and legal standards of outpatient surgery
15921399|NCT03486938|Drug|Placebo Oral Tablet|Placebo oral tablet
15921400|NCT03486938|Drug|AGB101 220 mg tablet|220 mg AGB101 active compound
15921401|NCT03486925|Drug|oxytocin treatment|intranasal administration of oxytocin (24IU)
15921402|NCT03486925|Drug|placebo treatment|intranasal administration of placebo
15921403|NCT03486912|Drug|BMS-986036|Specified dose on specified days.
15921404|NCT03486912|Other|Placebo|Specified dose on specified days.
15921405|NCT03486899|Drug|BMS-986036|Specified dose on specified days.
15921406|NCT03486899|Other|Placebo|Specified dose on specified days.
15921437|NCT03486704|Behavioral|Face to Face VRRS plus active tDCS and telerehabilitation|"Participants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS combined with active (anodal) tDCS applied to the left dorsolateral prefrontal cortex over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week.
~Face to Face VRRS cognitive training will initially be tailored to the patient's baseline characteristics.
~The exercise program will be charged by therapist on the patient's computer before the beginning of the at-home treatment. Each patient's performed session will be reviewed by the therapist.The group will receive a kit home-based (a tablet home, access to a daily individualized cognitive training program)."
15921407|NCT03486886|Diagnostic Test|PSMA -PET/CT scanning|"PET/CT scanning is performed on hybrid PET/CT scanners. Patients should fast for at least 4 hours to facilitate transit of oral contrast into the distal small bowel. An oral contrast product can be administered and [18F]-DCFPyL is injected by IV rapid bolus followed by saline flush. 80-100 minutes following [18F]-DCFPyL injection, CT and PET images are consecutively acquired from the base of the skull to the upper thighs. An MRI of the questioned lesion sites may be performed.
~Uptake of lesions is measured with SUVmax. Hepatic and blood pool SUV is determined for the computation of tumor-to-liver and tumor-to-blood ratios.
~15 patients max will undergo a second PSMA-PET scan on the same camera with the same protocol using a different tracer batch within 2 weeks of the initial PSMA-PET evaluation in order to determine test-retest repeatability of the imaging procedure using a Bland-Altman analysis (per lesion analysis)."
15921410|NCT03486860|Behavioral|Parent Psychoeducation|6-session parent psychoeducation group on child anxiety, following their children's lead, and encouraging approach behaviors.
15921411|NCT03486860|Behavioral|Turtle Program|The Turtle Program involves a child social and emotional skills group (Social Skills Facilitated Play) and a modification of Parent-Child Interaction Therapy in which parents are provided in-vivo coaching in following their children's lead and encouraging approach behaviors within the peer context. The child group provides a forum of same-age peers to learn to develop social and emotion regulation skills. The Turtle Program is administered over an 8-week period.
15921412|NCT03486847|Procedure|Repetitive recruitment with PEEP|Apply sustained airway pressure of 30-40 cmH2O for 10-20 seconds before suegery and once an hour during surgery. PEEP is set to 7 cmH2O.
15921413|NCT03486847|Procedure|One recruitment with PEEP|Apply sustained airway pressure of 30-40 cmH2O for 10-20 seconds before surgery. PEEP is set to 7 cmH2O.
15921414|NCT03486834|Biological|V160|V160 administered as a 0.5 mL (100 Units) IM injection containing Merck aluminum phosphate adjuvant (MAPA)
15921415|NCT03486834|Drug|Placebo|Saline solution administered as a 0.5 mL IM injection
15921416|NCT03486821|Radiation|Hypofractionated Radiation|All patients on this study will receive the same type of therapy, 2 treatment hypofractionated radiation therapy.
15921417|NCT03486808|Device|IFG stimulation|stimulating left inferior frontal cortex with transcranial direct current stimulation for 30 minutes
15921418|NCT03486808|Device|DLPFC stimulation|stimulating left dorsolateral prefrontal cortex with transcranial direct current stimulation for 30 minutes
15921419|NCT03486808|Device|Sham stimulation|sham stimulation over both left inferior frontal cortex and dorsolateral prefrontal cortex
15921420|NCT03486795|Device|M1 stimulation|stimulating primary motor cortex with anodal stimulation on right primary motor cortex and cathodal stimulation on left primary motor cortex
15921421|NCT03486795|Device|PMC stimulation|stimulating premotor cortex with anodal stimulation on right premotor cortex and cathodal stimulation on left supraorbital area
15921422|NCT03486795|Device|Sham stimulation|sham stimulation over both primary motor cortex and premotor cortex
15921423|NCT03486782|Device|IFG stimulation|stimulating inferior frontal cortex with transcranial direct current stimulation for 30 minutes
15921424|NCT03486782|Device|DLPFC stimulation|stimulating dorsolateral prefrontal cortex with transcranial direct current stimulation for 30 minutes
15921425|NCT03486782|Behavioral|aphasia therapy|aphasia therapy for 30 minutes during transcranial direct current stimulation
15921426|NCT03486769|Device|M1 stimulation|stimulating primary motor cortex with anodal transcranial direct current stimulation
15921427|NCT03486769|Device|PMC stimulation|stimulating premotor cortex with anodal transcranial direct current stimulation
15921428|NCT03486769|Device|aIPS stimulation|stimulating anterior intraparietal sulcus with anodal transcranial direct current stimulation
15921429|NCT03486769|Behavioral|hand motor task|hand motor task for 30 minutes during transcranial direct current stimulation
15921430|NCT03486756|Behavioral|Internet-CBT for anxiety-related asthma|The specific assignments in the intervention will be based on individual behavior analysis for each participant.
15921431|NCT03486743|Behavioral|Educational video on LARC|Participants will watch a short educational video on long acting reversible contraceptive or LARC
15921432|NCT03486730|Drug|BT1718|Dose escalation will consist of Stage 1 and 2. Stage 1 patients will receive BT1718 intravenously twice a week (D: 1,4,8,11,15,18) for 3 out of 4 weeks. Starting dose will be 0.6mg/m2. Single patient cohorts will be explored, but it will change to 3 to 6 patients cohorts. Stage 2 patients will receive BT1718 intravenously once a week (D: 1,8,15) for 3 out of 4 weeks. This stage will have 3 to 6 patient cohorts until the recommended dose is established. The expansion phase will consist of two or more expansion cohorts to include tumour types known to commonly over-express MT1-MMP and where MT1-MMP overexpression is confirmed during prospective selection at enrolment. A squamous NSCLC and basket cohort will include approximately 16 patients each with high MT1-MMP levels. In the expansion cohorts BT1718 will be administered intravenously at the once weekly RP2D established in Phase I, Stage 2.
15921433|NCT03486717|Device|Virtual reality goggles|Patients will act as their own control over two different dental appointments. One appointment will consist of wearing the virtual reality googles, the other appointment will be conducted without them. The goggles have a small screen inside of them along with headphones. This device will play an a movie or cartoon that will immerse the patient during treatment.
15921434|NCT03486704|Behavioral|Face to Face VRRS and telerehabilitation|"Face to Face cognitive training using VRRS plus telerehabilitation. Participants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week.
~Cognitive training will initially be tailored to the patient's baseline characteristics. The exercise program will be charged by therapist on the patient's computer before the beginning of the at-home treatment. Each patient's performed session will be reviewed by the therapist.
~The group will receive a kit home-based (a tablet home, access to a daily individualized cognitive training program)."
15921435|NCT03486704|Behavioral|Usual rehabilitation program|The usual rehabilitation group will receive 12 sessions of face-to-face usual cognitive training program.
15921505|NCT03486145|Dietary Supplement|Placebo|"PRU was provided by Isagenix International LLC in identically sealed bottles labeled labeled A. Subjects were not told which supplement they received. Each bottle contained one serving (two ounces) of the supplement."
15921438|NCT03486704|Behavioral|Face to Face VRRS plus placebo tDCS and telerehabilitation|"Participants will receive 12 sessions of an individualized Face to Face cognitive training using VRRS combined with placebo tDCS applied to the dorsolateral prefrontal cortex of the left hemisphere over 4 weeks followed by 36 sessions of home-based VRRS cognitive training, three sessions for week.
~Face to Face VRRS cognitive training will initially be tailored to the patient's baseline characteristics.
~The exercise program will be charged by therapist on the patient's computer before the beginning of the at-home treatment. Each patient's performed session will be reviewed by the therapist.The group will receive a kit home-based (a tablet home, access to a daily individualized cognitive training program)."
15921439|NCT03486691|Other|Routine measurement of left lobe|Routine preoperative measurement of left lobe
15921440|NCT03486691|Other|control group|no routine preoperative measurement of left lobe
15921442|NCT03486665|Other|Blood Sampling|Blood samples will be taken from all patients and healthy volunteers.
15921443|NCT03486665|Other|CSF Sampling|CSF sample will be taken from hospitalized newly diagnosed patients only.
15921444|NCT03486639|Other|IPSS questionnaire|IPSS is an 8 question (7 symptom questions + 1 quality of life question) written screening tool used to screen for, rapidly diagnose, track the symptoms of, and suggest management of patients with lower urinary tract symptoms. It was validated for both genders.
15921445|NCT03486626|Drug|Metformin|Metformin to increase pregnancy rate in polycystic ovarian syndrome patients
15921446|NCT03486613|Other|PROM registration via the DANBIO App on a smartphone|PROM data is reported through the DANBIO smartphone app
15921447|NCT03486613|Other|PROM registration via the touch screen solution|PROM data is reported through the touch screen solution
15921448|NCT03486600|Other|Fluid Resuscitation|Patients will be evaluated and the bleeding site to be investigated and hemorrhagic shock confirmed and there is an expected delay in blood and blood products transfusion for more than 40 minutes. 6% HES 130/0.4 (Voluven®) will be administered intravenously to maintain or restore hemodynamic stability up to a maximum dose of 50 mL/kg body weight.
15921449|NCT03486587|Drug|Bacillus Cereus tablets|Bacillus Cereus tablets was taken two tablets three times a day.
15921450|NCT03486574|Diagnostic Test|Positive result from pathological test|Presence/absence of gastric cancer will be evaluated by upper gastroendoscopy or results of pathological test
15921451|NCT03486561|Drug|Ranolazine|Ranolazine inhibits sodium and potassium ion channel currents. Inhibition of the late phase of the inward sodium current during cardiac repolarization has been well studied4. In disease states, enhanced sodium-calcium exchange due to augmented late phase of the inward sodium current activity leads to increased cytosolic calcium concentration. Intracellular calcium overload is believed to be critical to the mechanism of decreased left ventricular relaxation caused by ischemia and reperfusion. Elevated left ventricular diastolic wall tension compromises myocardial blood flow even further.
15921452|NCT03486548|Drug|bupivacaine and dexamethasone|adductor canal block with 0.33% bupivacaine 15 ml with ultrasound guided popliteal sciatic block with 0.125% bupivacaine 20 ml and dexamethasone 5 mg
15921453|NCT03486548|Drug|bupivacaine and lidocaine|adductor canal block with 0.33% bupivacaine 15 ml with ultrasound at popliteal sciatic area and subcutaneous infiltration popliteal area with 2% lidocaine 1 ml
15921454|NCT03486548|Device|Ultrasound|ultrasound
15921455|NCT03486535|Drug|Infraclavicular Brachial Plexus Blocks|All patients will receive Infraclavicular Brachial Plexus Blocks with the mixture of lidocaine and bupivacaine. This is an observational study, because all patients will receive the same blocks with the same doses of the local anesthetics. The only difference between groups is including patients with or without Diabetes Mellitus diagnosis. The intervention is the same and these patients cannot be randomized. The aim is investigating the effect of this local anesthetic mixture in Diabetic patients.
15921456|NCT03486535|Drug|Infraclavicular Brachial Plexus Blocks|All patients will receive Infraclavicular Brachial Plexus Blocks with the mixture of lidocaine and bupivacaine. This is an observational study, because all patients will receive the same blocks with the same doses of the local anesthetics. The only difference between groups is including patients with or without Diabetes Mellitus diagnosis. The intervention is the same and these patients cannot be randomized. The aim is investigating the effect of this local anesthetic mixture in Nondiabetic patients.
15921457|NCT03486509|Drug|Afatinib|afatinb 40mg po bid
15921458|NCT03486496|Drug|gefitinib|Patients will be treated with gefitinib, 250 mg p.o., daily
15921459|NCT03486496|Drug|Berberine|Patients will be treated with Berberine, 50 mg p.o., tid
15921460|NCT03486483|Other|Exercise|Intervention included 18 slackline rehabilitation sessions for 6 weeks: 3 sessions per week on non-consecutive days, 30 min each one.
15921461|NCT03486470|Diagnostic Test|Ultrasound examination of radial arteries|Measuring the diameter and the depth of two radial segments on both arms
15921462|NCT03486457|Drug|Tofacitinib|tablets, 5 mg BID x 6 months
15921463|NCT03486457|Other|Placebo|tablets, to match tofacitinib 5 mg BID x 3 months
15921464|NCT03486457|Drug|Tofacitinib|tablets, 5 mg BID x 3 months
15921465|NCT03486444|Diagnostic Test|Phillips Lumify Diagnostic Ultrasound System|portable ultrasound device
15921466|NCT03486444|Other|Surveys|surveys assessing perception of ultrasound
15921467|NCT03486431|Radiation|Stereotactic Ablative Radiotherapy (SABR)|A minimum of thirty patients will be included for each dose level. An interval of at least 24 weeks from the first patient treatment to the next patient treatment at each dose level will be respected. In the meantime, more patients will be included in the previous dose level, in an effort to establish the secondary endpoints. In case 1-5 patients present with dose-limiting toxicity (DLT) at 6 months after SABR, thirty additional patients will be included at the same dose level. The maximal tolerated dose will be defined as the dose level below which at least 10 patients present with a dose-limiting toxicity at 6 months after SABR.
15921468|NCT03486405|Other|Control group|Control group runners will receive the same graduated return to run intervals and 4-week home exercise program. However, they will receive no video education during the initial 10 weeks.
15949169|NCT03271047|Drug|ipilimumab|intravenously (IV) every 8 weeks (Q8W)
15921469|NCT03486405|Other|Intervention group|Runners randomized to the intervention group will receive additional video tele-health instruction on how to transition to a non-rearfoot strike (NRFS) running pattern. Runners in the intervention group will have additional tele-health follow-ups at weeks 1, 2, 4,6, 8, and 10 using a tele-conferencing program and the Hudl Technique application. At each tele-health video follow-up participants will be emailed a questionnaire assessing their progress and function. At month 6 a final data collection session to include video analysis will be performed.
15921470|NCT03486392|Drug|JNJ-64565111 Dose Level 1|Participants will receive JNJ-64565111 Dose Level 1 SC once -weekly until Week 26.
15921471|NCT03486392|Drug|JNJ-64565111 Dose Level 2|Participants will receive JNJ-64565111 Dose Level 2 SC once-weekly until Week 26.
15921472|NCT03486392|Drug|JNJ-64565111 Dose Level 3|Participants will receive JNJ-64565111 Dose Level 3 SC once-weekly until Week 26.
15921473|NCT03486392|Drug|Liraglutide|Participants will receive liraglutide at a starting dose of 0.6 mg then dose will be ramped up by 0.6 mg daily until reaching 3.0 mg. Participants will then continue on the 3.0 mg once-daily dosage until Week 26.
15921474|NCT03486392|Drug|Placebo|Participants will receive matching placebo SC once-weekly until Week 26.
15921475|NCT03486366|Other|non interventional trial|other
15921476|NCT03486353|Drug|FF-10501-01|FF-10501-01 round film-coated tablets are immediate release and come in 3 dosage strengths: 50 mg (tan), 100 mg tablets (red) and 200 mg (yellow). Each tablet contains the active ingredient (FF-10501-01 white crystalline powder) and other excipients. All dosage strengths are packaged 32 tablets to a bottle. FF-10501-01 should be stored at room temperature (20 - 25 °C).
15921477|NCT03486353|Drug|Azacitidine|azacitidine at a dose of 75 mg/m2 either subcutaneously (SC) or intravenously (IV) x 7 days every 28 days
15921478|NCT03486340|Procedure|Cardiologic assessment|Aggressive ischemic risk factor management
15921479|NCT03486327|Drug|BR55|A novel targeted ultrasound contrast agent
15921480|NCT03486314|Drug|Pevonedistat|Pevonedistat intravenous infusion.
15921481|NCT03486314|Drug|Rifampin|Rifampin capsules.
15921482|NCT03486314|Drug|Docetaxel|Docetaxel intravenous infusion.
15921483|NCT03486314|Drug|Carboplatin|Carboplatin intravenous infusion.
15921484|NCT03486314|Drug|Paclitaxel|Paclitaxel intravenous infusion.
15921485|NCT03486301|Drug|BDB001|BDB001 is an immunotherapy agent.
15921486|NCT03486301|Drug|Pembrolizumab|Pembrolizumab is a potent humanized monoclonal antibody with high specificity of binding to the PD 1 receptor. Pembrolizumab has an acceptable preclinical safety profile and is approved as an IV therapy for a variety of advanced malignancies.
15921487|NCT03486275|Device|Hygie|Prototype video game called Hygie, accessible on the Internet, on the 5 most common reasons of consultation in general practice using 9 articles from independent journals based on evidence (reviews by Prescrire and Minerva).
15921488|NCT03486275|Device|Source articles|9 articles from independent journals based on evidence (reviews by Prescrire and Minerva), about the 5 most common reasons of consultation in general practice, accessible on the Internet.
15921489|NCT03486249|Other|Repetition of medical examinations performed as part of the care|Cardiac echo, diaphragm ultrasound and phrenic nerves stimulation performed before the spontaneous breathing trial.
15921490|NCT03486236|Drug|VX-440|VX-440 was administered in TC with TEZ and IVA.
15921491|NCT03486236|Drug|TEZ|TEZ was administered as part of a fixed-dose combination (FDC) tablet (TEZ/IVA)
15921492|NCT03486236|Drug|IVA|IVA was administered as part of a FDC tablet (TEZ/IVA) and as a mono tablet
15921493|NCT03486236|Drug|Matched Placebos|Placebos matched to VX-440, TEZ, and IVA.
15921494|NCT03486223|Drug|GSK2256294|Drug will be taken daily by mouth for 7 days.
15921495|NCT03486223|Drug|Placebo oral capsule|Placebo will be taken daily by mouth for 7 days.
15921496|NCT03486223|Genetic|Genotyping|Genotyping for loss of function variants (EPHX2 287Gln) vs. wild-type allele
15921497|NCT03486210|Behavioral|Food preference|The study will take place in two phases. A first phase will consist in the validation of translations and the selection of images on 20 healthy volunteers and 20 health professionals specialized in nutrition. They will have to fill a form with images of food and evaluate to what extend they think the pictures represent what we can eat in France. This step will adapt the questionnaire to our country.
15921498|NCT03486210|Other|Psychological assesment|"Phase performed with patients fasting for at least 2 hours before the different tests. The FLPQ will be compared between a group of patients suffering from unoperated obesity (OCt), a group of patients operated on a sleeve gastrectomy (OSl) and a group operated by a bypass (OBy) between 6 and 24 months post-surgery, randomized for the 6 combined tests (2 categories). The award can be made in 2 sessions of at least 3 of the 6 tests combined. Each test combines 2 of the 11 categories. The test will consist of 96 pairs of 16 food images presented on a computer screen in color. Participants will be invited to choose the food they most want to eat, by pressing the corresponding computer button (choices saved by counting the frequency scores in E-prime).
~The level of hunger will be evaluated by an Analogical Visual Scale, ranging from 0 to 10.
~Patients should also complete 3 self-questionnaires used routinely (Binge Eating Scale, The Yale Food Addiction Scale, The UPPS-P short version)."
15921499|NCT03486197|Other|Laboratory Biomarker Analysis|Correlative studies
15921500|NCT03486197|Biological|Pembrolizumab|Given IV
15921501|NCT03486197|Radiation|Radiation Therapy|Undergo neutron radiation therapy
15921502|NCT03486184|Diagnostic Test|Cystatin-C|"Laboratory values will be obtained, including level of preoperative serum creatinine, complete blood count, coagulation profile and Cystatin-C (5 ml. venous sample).
~Serum creatinine and hemoglobin will be measured after operation, and thereafter at least once a day as a part of routine clinical care. Postoperative serum Cystatin-C will measured only once."
15921503|NCT03486158|Device|CalproSmart™ system|Home test kit for measurement of calprotectin in fecal samples. A new clinical tool for monitoring patients with inflammatory bowel disease, enabling measurement of calprotectin level of rapid test through a specially developed Smartphone application (platforms such as Android o Iphone)
15921504|NCT03486145|Dietary Supplement|fruit and vegetable juice supplement|"FVS was provided by Isagenix International LLC in identically sealed bottles labeled labeled B. Subjects were not told which supplement they received. Each bottle contained one serving (two ounces) of the supplement."
15921506|NCT03486132|Procedure|repair of episiotomy|Different techniques for repair of episiotomy incsicion
15921507|NCT03486119|Other|nivolumab|Subjects will be treated with 3mg/kg in nivolumab IV every 2 weeks for a maximum of 12 months.
15921508|NCT03486106|Other|Music|Music will be provided via Spotify, which is an Internet streaming music service, and will be played through headphones; this way, no other individual in the operating room will be distracted or influenced by the patient's music selection.
15921509|NCT03486106|Other|Headphones|All participants will receive noise-cancelling wireless headphones that they will wear in the operating room during the procedure.
15921510|NCT03486106|Drug|Propofol|All participants will receive intravenous doses of propofol; the timing and frequency of the doses will be given when the patient indicates (by squeezing a rubber duckie) that he/she wants sedation medication.
15921511|NCT03486093|Device|"Training and retraining to GAVECELT bundle recommendations plus port protector"|"Physicians and nurses of RICU have been trained and retrained to GAVECELT bundle recommendations concerning the management of CVC. The bundle includes: hand hygiene and precautions for protection and safety, adequate insertion site, echo-guided placement of central venous line, use of clorexidine 2% for skin disinfection of insertion site chosen and subsequent continuous or discontinuous disinfection of exit site, use of suture-less devices, use of transparent semi-permeable dressing whenever applicable and immediate removal of catheter when no longer needed.
~After the first training meeting, the use of Curos® Disinfecting Port Protector for needleless valves port-protector has been introduced."
15921512|NCT03486093|Behavioral|"Training and retraining to GAVECELT bundle recommendations"|"Physicians and nurses of RICU have been trained and retrained to GAVECELT bundle recommendations concerning the management of CVC. The bundle includes: hand hygiene and precautions for protection and safety, adequate insertion site, echo-guided placement of central venous line, use of clorexidine 2% for skin disinfection of insertion site chosen and subsequent continuous or discontinuous disinfection of exit site, use of suture-less devices, use of transparent semi-permeable dressing whenever applicable and immediate removal of catheter when no longer needed."
15921513|NCT03486080|Drug|Dutogliptin Tartrate|Active treatment
15921514|NCT03486080|Drug|Filgrastim Injectable Product|Active treatment
15921515|NCT03486080|Drug|Placebos|placebo control
15921516|NCT03486067|Drug|CC-93269|CC-93269
15921517|NCT03486054|Device|INTERCEPT|The pathogen reduction process begins with a unit of whole blood collected according to local standards and procedures at the blood center. The blood unit is treated with amustaline and glutathione (INTERCEPT blood system for whole blood) according to manufacturer's instructions. The INTERCEPT blood system is performed on a single unit of not leuco-reduced whole blood treated with amustaline and glutathione in CPD
15921518|NCT03486054|Device|Standard of Care|The control article is Standard of Care, either RBC or whole blood collected by the Centre National de Transfusion Sanguine (CNTS), processed according to the local procedure and in compliance with quality criteria defined by the manufacture regarding the volume, hemoglobin content, hematocrit, storage temperature, age of blood and storage in the predefined anticoagulant solution.
15921519|NCT03486041|Behavioral|Comprehensive Behavior Modification|Behavior therapy approach to BFRBs involving targeted intervention tactics chosen in accordance with the modality of functioning (ex: Sensory, Cognitive.....) seeming to cause the most frequent and problematic urges to engage in the BFRB. Therapist and client work together, using careful assessments including detailed self-monitoring, to determine what behavioral methods will suffice for lasting change.
15921520|NCT03486041|Behavioral|Attention|Weekly brief calls from therapist to check on safety and clinical status. No focus on TTM.
15921521|NCT03486028|Other|Adherence to ASAM protocols|ASAM Counties. These counties are requiring their providers to use ASAM criteria to assess patients and to determine level of care. These counties also use ASAM to determine the ongoing need for high-intensity services, such as residential, and approve those services for Medicaid payment.
15921522|NCT03486028|Other|Non-adherence to ASAM protocols|These counties are not implementing the ASAM criteria to assess patients and determine the level of care.
15921523|NCT03486015|Drug|Sterile water|2 ml of sterile water
15921524|NCT03486015|Drug|30% glucose|2 ml of 30% glucose
15921525|NCT03486002|Device|Cleansweep|The Cleansweep closed suction system
15921526|NCT03486002|Device|Halyard|Halyard Closed Suction System
15921527|NCT03485989|Other|Hazelnuts|Dry roasted, individually packaged hazelnuts provided from the Hazelnuts Marketing Board of Oregon
15921528|NCT03485976|Drug|Ixekizumab|Treatment at the FDA-approved psoriasis dosing
15921529|NCT03485963|Biological|HST-NEETs|The primary objective of this study is to evaluate the safety and tolerability of expanded HIV-specific T cell therapy (HST-NEETs) in HIV-infected individuals suppressed on cART. Patients with a partial response or stable disease 8 weeks after T-cell infusion were eligible to receive additional T-cells, consisting of the same number of cells as their second injection.
15921530|NCT03485950|Drug|Cefepime|Given IV
15921531|NCT03485950|Drug|Ceftolozane|Given IV
15921532|NCT03485950|Other|Laboratory Biomarker Analysis|Correlative studies
15921533|NCT03485950|Drug|Meropenem|Given IV
15921534|NCT03485950|Drug|Piperacillin-Tazobactam|Given IV
15921535|NCT03485950|Drug|Tazobactam|Given IV
15921536|NCT03485937|Behavioral|Pre-Operative Videos|Videos will be created by the study team to ensure that the content coincides with what is delivered in the standard-of-care verbal and written instructions. The videos will be split into two modules: 1) preparing for Mohs Surgery 2) Mohs Surgery Walk through. The intervention, in the form of a video walk through, will be provided to the patient via email prior to their surgical procedure once they schedule an appointment with the Mohs clinic for their surgery day.
15921537|NCT03485937|Behavioral|verbal instructions|As part of the standard of care for patients receiving Mohs surgery, patients are told about the day of their surgery and what to expect
15921538|NCT03485937|Behavioral|written instructions|As part of the standard of care for patients receiving Mohs surgery, patients receive written material about the day of their surgery and what to expect
15921539|NCT03485924|Diagnostic Test|EUS-FNA with ROSE|EUS-FNA with ROSE vs EUS-FNB without ROSE
15921540|NCT03485924|Diagnostic Test|EUS-FNB without ROSE|EUS-FNA with ROSE vs EUS-FNB without ROSE
15921541|NCT03485911|Drug|BCX7353 capsules|BCX7353 oral capsules administered once daily
15921542|NCT03485911|Drug|Placebo oral capsule|Matching oral capsules administered once daily
15949626|NCT03267355|Device|Endoscopic Ultrasound|Indication of EUS
15921543|NCT03485885|Dietary Supplement|Standardized maqui berry extract enriched in anthocyanins|Single oral intake of 1000mg standardized maqui berry extract (in 4 capsules - 250mg each) with 200ml still water
15921544|NCT03485872|Other|Self-Screening and Referral Information|Urinary incontinence self-screening questionnaire, fact sheet and self-referral information will be provided by mail or email.
15921545|NCT03485872|Other|Standard Care|Demographic and quality of life questionnaires; standard care provided by participants' GPs
15921546|NCT03485859|Device|Experimental group|In subjects allocated to the abdominal binder group, the abdomen binder with a standard height of 22 cm (Sejung Korea, Seoul, Republic of Korea) was applied before leaving the operating room. The binder was placed on the abdomen across the laparoscopic incision, with the upper border not higher than the lower margin of the rib cage, ensuring minimal restriction of lateral costal expansion and diaphragmatic excursion. Subjects were carefully instructed to use the abdominal binder during at least the first 2 consecutive days and night, and to reposition the abdominal binder correctly when needed.
15921547|NCT03485859|Device|Control group|In subjects allocated in the control group, subjects were not given any opportunity to ware an abdominal binder.
15921548|NCT03485846|Drug|Narlaprevir|100 mg, oval shaped, concave, yellow film-coated, tablets taken as 200 mg per os daily
15921549|NCT03485846|Drug|Ritonavir|100 mg, tablets, taken as 100 mg per os daily
15921550|NCT03485846|Drug|Daclatasvir|60 mg, tablets, taken as 60 mg per os daily
15921551|NCT03485833|Diagnostic Test|EEO and EIO test|velocity time integral of the aorta measured by transesophageal echocardiography after end-expiratory and end-inspiratory occlusion test
15921552|NCT03485820|Behavioral|COMPASS|The data from the baseline assessment will be used to develop an environmental modification intervention plan. Environmental modifications will be installed before discharge if possible. Problem areas addressed are participant specific (tailored), but the process to identify and address the target area is systematic. All participants will receive identical intervention components. The standardized components include assessment, identification of problematic activities (and environmental barriers), identification of three solutions (for each problem), implementation of solution set selected by the participant, training, and active practice of daily activities in one's own home and community.
15921553|NCT03485820|Behavioral|Stroke education|The control group will experience the same effects of time and attention in the home but no effect on the outcome of interest.
15921554|NCT03485807|Behavioral|Mindfulness Training (MT)|2 week SmartPhone-based mindfulness training
15921555|NCT03485807|Behavioral|Active Coping Training (CT)|2 week SmartPhone-based structurally equivalent coping training
15921556|NCT03485794|Procedure|Biospecimen Collection|Undergo collection of blood
15921557|NCT03485794|Other|Laboratory Biomarker Analysis|Correlative studies
15921558|NCT03485768|Procedure|percutaneous disc decompression with coblation nucleoplasty|PDCN was performed using the COBLATION Perc-DC SpineWand surgical device (ArthroCare System 2000, ArthroCare corporation, Heredia, Costa Rica, USA) under local anesthesia. The introducer cannula was then pierced into the target intervertebral disc through an anterior lateral approach. The tip of the cannula stylet was aimed for the center of the nucleus in both the coronal and sagittal planes. The stylet was withdrawn from the introducer cannula and replaced with the Perc-DC SpineWand. The wand was advanced until its tip extended approximately 5 mm beyond the tip of the cannula. A short initial coagulation was performed upon wand insertion to ensure correct placement, if stimulation or movement was detected, the wand was repositioned. As the wand was drawn back out through the disc, ablation energy was set to level three and three ablation cycles of 5-12soconds each were performed, rotating the wand tip 180 degree each time to form three consecutive pockets within the disc.
15921559|NCT03485768|Procedure|Manual Therapy (SNAGs plus PJMs)|"(1) sustained natural apophyseal glides (SNAGs): Use the methods described in Mulligan BR. Manual therapy NAGS, SNAGS, MWMS etc. 5th ed. Wellington, New Zealand: Plane View Services; 2004. Three sessions per week and for a total of four to six weeks according to the patients' condition, they were asked to continue the self-SNAG once daily until the last follow-up, and recorded in a diary. (2) passive joint mobilisations (PJMs): Use the methods described in Maitland G. Vertebral manipulation. 6th ed. Oxford: Butterworth Heinemann; 2001. For three repetitions weekly and for a total of four to six weeks according to the patients' condition, then once a day were commenced as a home exercise to be continued until the last follow-up, and recorded in a diary."
15921560|NCT03485742|Other|No intervention|No intervention. Collection of data on statin eligibility in patients admitted with MI
15921561|NCT03485729|Drug|ONC201|ONC201
15921562|NCT03485716|Other|running on a treadmill under normoxia or hypoxia|"30 min running (60% VO2max) on a treadmill under hypoxia (O2: 14%)
~30 min running (60% VO2max) on a treadmill under normoxia (O2: 20%)"
15921563|NCT03485703|Drug|Azithromycin|the newborn group will receive intravenous azithromycin 10 mg / kg / day once daily for 5 days
15921564|NCT03485703|Drug|Placebo|the group of newborns will receive 0.9% saline once daily for 5 days
15921565|NCT03485677|Drug|Eliglustat GZ385660|"Pharmaceutical form: Capsule, Liquid
~Route of administration: Oral"
15921566|NCT03485677|Drug|Imiglucerase GZ437843|"Pharmaceutical form: Powder for solution for infusion
~Route of administration: Intravenous"
15921567|NCT03485664|Procedure|tooth extraction|tooth extraction
15921568|NCT03485625|Drug|Lidocaine|Two cannulae were placed, one in a vein on the dorsum of the operative hand and the other on the non operative hand for i.v fluids. The operative arm was elevated for 2 min and was then exsanguinated with an elastic bandage. A pneumatic tourniquet was then placed around the upper arm, and the cuff was inflated to 100 mm Hg above systolic BP. Circulatory isolation of the arm was verified by inspection, absence of a radial pulse, and a loss of the pulse oximetry tracing in the ipsilateral index fingers The solutions were prepared by an anesthesiology assistant not involved in any part of the study. The solutions were injected over 90 s by an anaesthesiologist.
15921569|NCT03485625|Drug|Ketorolac|Two cannulae were placed, one in a vein on the dorsum of the operative hand and the other on the non operative hand for i.v fluids. The operative arm was elevated for 2 min and was then exsanguinated with an elastic bandage. A pneumatic tourniquet was then placed around the upper arm, and the cuff was inflated to 100 mm Hg above systolic BP. Circulatory isolation of the arm was verified by inspection, absence of a radial pulse, and a loss of the pulse oximetry tracing in the ipsilateral index fingers The solutions were prepared by an anesthesiology assistant not involved in any part of the study. The solutions were injected over 90 s by an anaesthesiologist.
15921570|NCT03485625|Drug|paracetamol|Two cannulae were placed, one in a vein on the dorsum of the operative hand and the other on the non operative hand for i.v fluids. The operative arm was elevated for 2 min and was then exsanguinated with an elastic bandage. A pneumatic tourniquet was then placed around the upper arm, and the cuff was inflated to 100 mm Hg above systolic BP. Circulatory isolation of the arm was verified by inspection, absence of a radial pulse, and a loss of the pulse oximetry tracing in the ipsilateral index fingers The solutions were prepared by an anesthesiology assistant not involved in any part of the study. The solutions were injected over 90 s by an anaesthesiologist.
15921571|NCT03485612|Diagnostic Test|Change of Optic Nerve Sheath Diameter|In patients, the optic nerve sheath width (ONSD) examination will be performed twice: for the first time immediately after general anesthesia and again after surgery after placing the patient in a position on the back.
15921572|NCT03485599|Diagnostic Test|ELIZA , Westron blot|Blood sample will be taken then rapid test by ELIZA will be done if positive then confirmatory test by Westron blot will be done
15921573|NCT03485586|Device|Traditional ultrasound biometrics|To evaluate the clinical feasibility of using a new optical coherence interferometry ( lenstar ),comparing with traditional ultrasonic biometry and keratometry in the accuracy and characteristics for intraocular lens calculation of cataract after PPV
15921574|NCT03485586|Device|Lenstar|To evaluate the clinical feasibility of using a new optical coherence interferometry ( lenstar ),comparing with traditional ultrasonic biometry and keratometry in the accuracy and characteristics for intraocular lens calculation of cataract after PPV
15921575|NCT03485560|Combination Product|ACE CSD|Topical application of the ACE CSD 4 times daily.
15921576|NCT03485547|Drug|Venetoclax|VENCLEXTA targets BCL-2 in order to help restore the process of apoptosis. Through apoptosis, your body allows cancer cells and normal cells to self-destruct
15921577|NCT03485534|Drug|Tenofovir Disoproxil Fumarate|Viread 300mg
15921578|NCT03485534|Drug|Tenofovir Disoproxil|Virehepa 245mg
15921579|NCT03485521|Procedure|The tracheobronchial aspiration|"Reading of the procedures of the tracheobronchial aspiration (legislative framework, rules of hygiene, procedures, undesirable effects) The Practical Group participates in a practical work lasting two hours and the Stimulation Group is in simulation with a procedural practice of tracheobronchial suction as part of a simulation sequence. This group benefits from the methodology of the simulation with a part of briefing, a part simulated session and to finish the debriefing.
~The experiment finished with a real activity on patients with tracheotomy with in this environment the reproduction of the procedure"
15921580|NCT03485508|Diagnostic Test|Transthoracic echocardiography|Transthoracic echocardiography Blood sample with assessment of biomarkers
15921581|NCT03485495|Drug|Divaza|Oral administration.
15921582|NCT03485495|Drug|Placebo|Oral administration.
15921583|NCT03485482|Drug|Bisoprolol|bisoprolo 5 mg tablets
15921584|NCT03485482|Drug|Ivabradine|Ivabradine 10 mg tablet
15921585|NCT03485482|Drug|combination of Ivabradine and bisoprolol|combination of 10 mg ivabradine and 5 mg bisoprolol
15921586|NCT03485469|Behavioral|Hypnosis|"There ar 10 hypnosis sessions :
~1st session of hypnosis : relaxation and orientation towards emotional cleansing.
~2nd session of hypnosis: oriented towards digestion, physical and psychological
~3rd session of hypnosis: oriented towards the feeling of security.
~4th session of hypnosis: self-esteem oriented.
~5th hypnosis session: oriented towards emotional management.
~6th hypnosis session: oriented towards self-confidence.
~7th hypnosis session: oriented towards the completion of the projects.
~8th, 9th and 10th sessions: concern the learning of self-hypnosis and autonomy. A USB key containing the induction of a session of autohypnosis will be given to the subject to promote the continuation of home-made auto-hypnosis."
15921587|NCT03485469|Behavioral|Standard Care|The dietary advice given during these dietary consultations is part of the standard care adapted to patients who have undergone bariatric surgery while increasing the frequency of consultations (Fractionation of meals, Volume of meals, Taking meals, Drinks, Food diversity)
15921588|NCT03485456|Drug|Tobramycin|Tobramycin dry powder inhalation with 30, 60 and 90 mg. Nebulisation with 300 mg tobramycin
15921589|NCT03485443|Drug|%0.9 NaCl 10ml/kg|Fluid administration
15921590|NCT03485443|Drug|%0.9 NaCl 20ml/kg|Fluid administration
15921591|NCT03485430|Behavioral|Tapering|Tapering with follow up by nurse at weekly basis in beginning of tapering. Tapering in an outpatient setting. Follow-up to doctor after four months.
15921592|NCT03485417|Drug|Aripiprazole|for oral or depot preparation
15921593|NCT03485417|Drug|Paliperidone|for oral or depot
15921594|NCT03485417|Other|Treatment as Usual|to be decided by treating psychiatrist with Rx other than aripiprazole or paliperidone
15921595|NCT03485404|Drug|methylcobalamin|methylcobalamin tablets, 0.5mg/tablet, 3 tablets/day.
15921596|NCT03485404|Drug|Folic Acid|folic acid tablets, 5mg/tablet, 1 tablet/day
15921597|NCT03485404|Other|Placebo for methylcobalamin|orange tablets that looks exactly like methylcobalamin
15921598|NCT03485404|Other|Placebo for folic acid|yellow tablets that looks exactly like folic acid
15921599|NCT03485404|Procedure|non-cardiac surgery|patients elective for non-cardiac surgery will undergo scheduled surgery after 7 days of intervention
15921600|NCT03485404|Behavioral|NPB test|participants will accept Mini-Mental State Examination (MMSE), Patient Health Questionnaire (PHQ-9), ADL, and NPB test before intervention, and NPB by discharge or similar time intermittent after the first assessment for non-surgical controls. Also ADL will be tested again through telephone interview at 3 months after discharge.
15921601|NCT03485391|Behavioral|Prolonged Exposure|Practice guidelines have identified that trauma-focused psychotherapies have most evidence for treatment PTSD. Prolonged Exposure (PE) is one type of trauma-focused psychotherapy. PE teaches you to gradually approach trauma-related memories, feelings, and situations that you have been avoiding since your trauma. By confronting these challenges, you can decrease your PTSD symptoms. Treatment will last anywhere from 8-12 weeks for 75-90 minutes, once per week.
15921602|NCT03485378|Radiation|Stereotactic Ablative Radiotherapy|Stereotactic ablative radiotherapy for early non-small cell lung cancer and interstitial lung disease
15921603|NCT03485365|Drug|GSK3858279 IV|GSK3858279 will be available as solution for injection to be administered via IV route.
15921604|NCT03485365|Drug|GSK3858279 SC|GSK3858279 will be available as solution for injection to be administered via SC route.
15921676|NCT03484754|Biological|botulinum toxin|injection of botulinum toxina in two different facial sites
15921605|NCT03485365|Drug|Placebo matching to GSK3858279 (SC or IV)|Placebo will be available as sodium chloride solution to be administered via SC or IV route.
15921606|NCT03485365|Drug|Placebo matching to GSK3858279 (SC)|Placebo will be available as sodium chloride solution to be administered via SC route.
15921607|NCT03485339|Diagnostic Test|genome testing|blood sampling via venipuncture
15921608|NCT03485300|Diagnostic Test|Liver and kidney function tests for patients with chronic liver or kidney diseases|Tests will be done to patients with history suggestive of chronic liver or renal diseases or for patients clinically suspected
15921609|NCT03485300|Behavioral|Non compliance of the patient|I will order all my patients to take the drug at 10 am and assure the daily in taking of the dose and they will be followed up
15921610|NCT03485300|Drug|Drug or food interactions|The patient will be in contact with the researcher for any drug added with warfarin in case of other co morbidity conditions and follow up his/her CBC and INR for measuring its effect on warfarin finding out the effect of food on warfarin therapeutic outcome
15921611|NCT03485287|Drug|MDMA|Three sessions of MDMA-assisted therapy with flexible dose of MDMA from 100 to 125 mg and optional supplemental dose half that of initial dose 1.5 to 2 hours later
15921612|NCT03485287|Behavioral|Therapy|Non-directive therapy
15921613|NCT03485274|Drug|Vortioxetine|oral medication taken once daily
15921614|NCT03485274|Other|Treatment as Usual|Any pharmacological or non-pharmacotherapy modalities other than use of vortioxetine
15921615|NCT03485248|Dietary Supplement|Beetroot Juice|140ml of Beetroot Juice containing on avarege 9 mmol of nitrate
15921616|NCT03485248|Dietary Supplement|Placebo|140ml of Beetroot Juice (nitrate free)
15921617|NCT03485235|Procedure|D&C|Dilatation and curettage
15921618|NCT03485235|Procedure|ICSI|Intra Cytoplasmic Sperm Injection
15921619|NCT03485222|Drug|Empagliflozin|6 months
15921620|NCT03485222|Drug|Placebos|placebo equivalent for 6 months
15921622|NCT03485196|Other|Microsatellite instability|The microsatellite instability status are definite to three type:MSI-H, MSI-L,and MSS. The gastric cancer patients who received D2 resection were included in 3 groups：MSI-H group， MSI-L group，and MSS group. All patient must be accept fluorouracil(5-FU) based adjuvant chemotherapy. We will analyze the relationship between MSI status and efficacy of 5-FU based adjuvant chemotherapy by observing the survival period of patients with different MSI status.
15921623|NCT03485183|Device|White/Pink Noise|White and/or pink noise will be played from 2200 to 0700 using the PicTek® white noise machine.
15921624|NCT03485183|Other|Control Group|Standard of care including lights on during the day and off at night, getting the patient out of bed for meals, presence of a large wall clock in the room, updating the whiteboard with current day, consistent reorientation of patient, geriatrician consults as needed, and pain management.
15921625|NCT03485170|Diagnostic Test|18F-FDG PET/CT|glucose analogue fluorine-18-fluorodeoxyglucose positron emission tomography with computed tomography scan
15921626|NCT03485157|Biological|Micronized DHACM|Injection of 40 mg micronized dehydrated human amnion chorion membrane (dHACM) suspended in 1 mL 0.9% Sodium Chloride, USP
15921627|NCT03485157|Drug|Saline|Injection of 1 mL 0.9% Sodium Chloride, USP
15921628|NCT03485144|Biological|TV003|Live attenuated virus vaccine-TetraVax-DV
15921629|NCT03485144|Biological|Placebo for TV003|Placebo
15921630|NCT03485131|Device|Transcranial direct-current stimulation (tDCS)|Stimulation sessions will be conducted twice a day on 5 consecutive weekdays. The twice daily sessions will be separated by at least 3 hours (one in the morning and the other one in the PM). The duration of treatment will be 4 weeks
15921631|NCT03485131|Device|Placebo|Placebo/sham stimulation: After 40 seconds of real stimulation of 2 mAmp to simulate the tDCS induced skin sensation, only a small current pulse is delivered every 550 msec (110 mAmp over 15 msec) through the remainder of the 20-minute period
15921632|NCT03485118|Drug|HS006+CHOP|"Drug:HS006 HS006 375 mg per square meter (mg/m^2),administered intravenously(IV) on Day1 of each 21-day cycle for 6 cycles.
~Drug :Cyclophosphamide Cyclophosphamide 750mg per square metre(mg/m^2),administered intravenously(IV) on Day 2 of each 21-day cycle.
~Drug :Doxorubicin Doxorubicin 50mg per square metre( mg/m^2),administered intravenously(IV) on Day 2 of each 21-day cycle.
~Drug :Vincristine Vincristine 1.4mg(maximum 2.0mg) per square metre (mg/m^2),administered intravenously(IV) on Day 2 of each 21-day cycle.
~Drug: Prednisone Prednisone 100 mg administered orally on Days 2-6 of each 21-day cycle."
15921633|NCT03485118|Drug|HS006+CHOP|"Drug:HS006 HS006 500 mg per square meter (mg/m^2),administered intravenously(IV) on Day1 of each 21-day cycle for 6 cycles. During cycle 1,HS006 also infused on Day 8 and 15.
~Drug :Cyclophosphamide Cyclophosphamide 750mg per square metre(mg/m^2),administered intravenously(IV) on Day 2 of each 21-day cycle.
~Drug :Doxorubicin Doxorubicin 50mg per square metre( mg/m^2),administered intravenously(IV) on Day 2 of each 21-day cycle.
~Drug :Vincristine Vincristine 1.4mg(maximum 2.0mg) per square metre (mg/m^2),administered intravenously(IV) on Day 2 of each 21-day cycle.
~Drug: Prednisone Prednisone 100 mg administered orally on Days 1-5 of each 21-day cycle."
15921634|NCT03485118|Drug|Rituximab+CHOP|"Drug:Rituxan Rituxan 375 mg per square metre (mg/m^2), administered by intravenous (IV) on Day 1 of each 21-day cycle.
~Drug :Cyclophosphamide Cyclophosphamide 750mg per square metre(mg/m^2),administered intravenously(IV) on Day 2 of each 21-day cycle.
~Drug :Doxorubicin Doxorubicin 50mg per square metre( mg/m^2),administered intravenously(IV) on Day 2 of each 21-day cycle.
~Drug :Vincristine Vincristine 1.4mg(maximum 2.0mg) per square metre (mg/m^2),administered intravenously(IV) on Day 2 of each 21-day cycle.
~Drug: Prednisone Prednisone 100 mg administered orally on Days 2-6 of each 21-day cycle."
15921635|NCT03485092|Drug|Empagliflozin 10 MG|Empagliflozin 10mg tablets for oral self administration once a day
15921636|NCT03485092|Drug|Placebo Oral Tablet|placebo tablets for oral self administration once a day
15921637|NCT03485066|Behavioral|Tetris|The video game Tetris is a cognitively challenging task, which requires mental rotation, problem solving and fast visuo-spatial and motor coordination.
15921639|NCT03485027|Drug|XELOX regimen|reintroduction of the XELOX regimen in the third or later line treatment after the same chemotherapy to which tumor has already proved to be resistant
15921640|NCT03485027|Drug|FOLFOX regimen|reintroduction of the FOLFOX regimen in the third or later line treatment after the same chemotherapy to which tumor has already proved to be resistant
15921641|NCT03485027|Drug|FOLFIRI regimen|reintroduction of the FOLFIRI regimen in the third or later line treatment after the same chemotherapy to which tumor has already proved to be resistant
15921642|NCT03485027|Drug|IRI regimen|reintroduction of the irinotecan single agent in the third or later line treatment after the same chemotherapy to which tumor has already proved to be resistant
15921643|NCT03485014|Drug|Exparel|EXPAREL 4 mg/kg
15921644|NCT03485001|Other|Sham|This group will not receive argon laser medical treatment; instead, they will be only exposed to the slit lamp light.
15921645|NCT03485001|Procedure|Argon Laser Treatment|This group will receive argon laser medical treatment to the body and head of pterygium
15921646|NCT03484988|Dietary Supplement|Placebo oil|The participants were asked to take corn oil capsule twice a day, 4 capsules (500mg/capsules) each time. The intervention period is about 3 months. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.
15921647|NCT03484988|Dietary Supplement|Echium oil|The participants were asked to take echium oil capsule twice a day, 4 capsules (500mg/capsules) each time. The intervention period is about 3 months. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.
15921648|NCT03484988|Dietary Supplement|Mixed oil|The participants were asked to take mixed oil(echium oil,camelina oil,safflower oil) twice a day, 4 capsules (500mg/capsules) each time. The intervention period is about 3 months. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.
15921649|NCT03484975|Device|Observation group|Collect coronary images with a hybrid IVUS OCT system.
15921650|NCT03484962|Biological|Activated CIK and CD3-MUC1 Bispecific Antibody in Treating Liver Cancer|CIK cells was activated by PD-1 inhibitor and bispecific antibody of anti-CD3/MUC1
15921651|NCT03484962|Procedure|cryotherapy|the maximum tumor length≥2 cm，cool down the lesion,result in degeneration, necrosis or loss of the lesion.
15921652|NCT03484949|Diagnostic Test|pre-endoscopic screening risk assessment|pre-endoscopic screening risk assessment
15921653|NCT03484936|Procedure|Remote ischemic conditioning|Remote ischemic conditioning (RIC) is induced by 4 cycles of 5 min of healthy upper limb ischemia followed by 5 min reperfusion. Limb ischemia was induced by inflations of a blood pressure cuff to 200 mm Hg. RIC will be conducted twice daily for 7 days.
15921654|NCT03484936|Procedure|Sham remote ischemic conditioning|Sham remote ischemic conditioning (Sham RIC) is simulated by the measurement of blood pressure twice daily for 7 days.
15921655|NCT03484923|Drug|Spartalizumab|400 mg every 4 weeks intravenously (i.v)
15921656|NCT03484923|Drug|LAG525|Taken intravenously (i.v)
15921657|NCT03484923|Drug|Capmatinib|Taken orally
15921658|NCT03484923|Drug|Canakinumab|Taken subcutaneusly (s.c)
15921659|NCT03484923|Drug|Ribociclib|Taken orally
15921660|NCT03484910|Other|Exercise therapy|Six-week training program of stationary cycling with / without a real-time visual EMG biofeedback
15921661|NCT03484897|Other|P927 - LICHTENA DermAD CREMA CORPO|The study cream was applied once a day (at the morning or at the evening), preferentially always at the same hour, with a mild massage, for an uninterrupted period of 1 month
15921662|NCT03484884|Diagnostic Test|Cerenkov luminescence imaging.|Cerenkov luminescence imaging will be obtained from MSKCC patients who are scheduled for routine FDG PET scan or 131I therapy that emit a continuum of ultraviolet and visible light from the decay of certain radionuclides.
15921663|NCT03484858|Other|High glycaemic index meal and exercise|
15921664|NCT03484858|Other|High glycaemic index meal and rest|
15921665|NCT03484858|Other|Low glycaemic index meal and exercise|
15921666|NCT03484858|Other|Low glycaemic index meal and rest|
15921667|NCT03484845|Drug|Lactoferrin and ferrous fumarate|"Group 1:include 50 women will receive oral lactoferrin 100mg twice daily .
~Group 2: include 50 women will receive oral Ferrous fumarate 30mg elemental iron twice daily .
~Group 3: include 50 women will receive oral combined lactoferrin 200mg and ferrous fumarate 60mg elemental iron once daily ."
15921668|NCT03484832|Device|Walter Ritter Ethyl Chloride Spray|Participants receive an application of EMLA or placebo cream at the needle electrode insertion site 60 minutes before needle insertion, and a self adhering dressing is placed over the site. After 60 minutes, the dressing and cream are removed from the site, then the insertion site is sprayed from a distance of 30 cm for 5 seconds or until the skin was blanched, then intra-articular injection of shoulder is performed.
15921669|NCT03484832|Other|Placebo Spray|Participants receive an application of EMLA or placebo cream at the needle electrode insertion site 60 minutes before needle insertion, and a self adhering dressing is placed over the site. After 60 minutes, the dressing and cream are removed from the site, then the insertion site is sprayed using placebo spray (Evain Eau Minerale Naturelle, a pure water spray with hydrocarbon propellant), then intra-articular injection of shoulder is performed.
15921670|NCT03484832|Other|Placebo Cream|Participants receive an application of placebo cream at the needle electrode insertion site 60 minutes before needle insertion, and a self adhering dressing is placed over the site. After 60 minutes, the dressing and cream are removed from the site, then the insertion site is sprayed using Walter Ritter Ethyl chloride spray or placebo spray, then intra-articular injection of shoulder is performed.
15921671|NCT03484832|Drug|EMLA Cream|Participants receive an application of EMLA cream at the needle electrode insertion site 60 minutes before needle insertion, and a self adhering dressing is placed over the site. After 60 minutes, the dressing and cream are removed from the site, then the insertion site is sprayed using Walter Ritter Ethyl chloride spray or placebo spray, then intra-articular injection of shoulder is performed.
15921672|NCT03484819|Drug|Copanlisib Hydrochloride|Given IV
15921673|NCT03484819|Biological|Nivolumab|Given IV
15921674|NCT03484793|Other|AESOP service system|Investigators develop an electronic reminder in CPOE system which notifies physicians when there appears to be an inappropriate prescription. At the time, a physician saves a typed prescription, our system analyzes the patient's medications, diseases and uses the knowledge base to determine whether a medication is uncommonly prescribed to all diseases in a given prescription. If the system detects the common associations of medications and diseases in a given prescription, it considers an appropriate prescription, and, if not, an actionable reminder is shown onscreen. To the right of each suggested uncommon medication is a reason why the reminder is appearing. Physicians can accept the reminder or ignore the reminder.
15921675|NCT03484780|Device|VisONE ADS|VisONE stimulator and leads for delivering continual Synchronized Diaphragmatic Stimulation
15921677|NCT03484741|Biological|MSC and PRP|MSC are collected from autologous bone marrow mononuclear cells (BMNC) and allogeneic umbilical cord tissue (UC-MSC) under sterile conditions and combined with activated platelet-rich plasma (PRP) to treat this disease.
15921678|NCT03484728|Behavioral|placebo manipulation|application of nonactive body cream on forearm
15921679|NCT03484715|Behavioral|Physical Activity Intervention|A physical activity programme will be developed by the researcher for each participant. Integral to each physical activity programme will be a walking component (i.e. structured and gradual increases in daily walking time) and sit-to-stand exercises (i.e. a specified number of repeated rises from a chair). The rest of the physical activity programme will be tailored around each participant's specific functional goal and will be based on repeating particular functional activities. This programme will take place on 3 days per week in month 1, 4 days per week in month 2 and 3, and 5 days a week in month 4.
15921680|NCT03484702|Drug|JCAR017|JCAR017
15921681|NCT03484689|Behavioral|Mindfulness-based cognitive therapy MBCT|8-week mindfulness-based cognitive therapy
15921682|NCT03484676|Device|Titinium|custom made plate at one point after 3D virtual simulation and reduction of the complex using Mimics software.
15921683|NCT03484663|Device|central venous catheter (small catheter drainage)|Insertion central venous catheter ( small catheter drainage ) after uniport vats to decrease hospital stay and to easy drainage after procedure
15921684|NCT03484650|Drug|Lidocaine Hydrochloride|Lidocaine bolus to be given 1 hour pre-operatively
15921685|NCT03484650|Drug|Lidocaine Hydrochloride|Lidocaine infusion will be started after the bolus and be continued for 24 hours post-operatively
15921686|NCT03484650|Other|Placebo|Control patients will receive a placebo bolus and infusion of saline to match the experimental arm.
15921687|NCT03484637|Other|Lifestyle-medicine intervention|
15921688|NCT03484624|Device|Treadmill walking|All subjects underwent measurements of muscle fatigue and respiratory metabolism energy during treadmill walking at a comfortable speed for 6 minutes and measured by three conditions (①NoGEMS-free gait, ②Torque off with GEMS, and ③Torque on with GEMS)
15921689|NCT03484611|Drug|GnRH antagonist|0,25mg s.c, cetrotide, serono laboratories, Aubonne Switzerland) is given using flexible protocol, it is given when at least one follicle reaches size 14 mm to prevent premature lutenization ,until the day of hCG administration
15921690|NCT03484611|Drug|Gonadotropins|started on day 2 of the menstrual cycle until the day of HCG administration(choriomon,IBSA10000IU)with starting dose 300IU to 450IU
15921691|NCT03484611|Drug|Human chorionic gonadotropin|10000 IU is given to induce final oocytes maturation when at least 2 follicles reached 14 mm or more
15921692|NCT03484611|Procedure|Embryo transfer|0ne to three grade 1 or 2 embryos were transferred on day 3 after oocyte retrieval. Embryo transfer was performed with a Wallace catheter (Smith Medical International Ltd, Hythe, Kent, UK)
15921693|NCT03484611|Drug|Progesterone|vaginal prontogest 400 mg twice daily
15921694|NCT03484598|Device|SPEAC System|A lightweight, non-invasive monitor that is placed on the belly of the biceps muscles to analyze surface electromyography (sEMG) signals that may be associated with generalized tonic-clonic (GTC) seizures. It provides an alarm to alert caregivers of unilateral, appendicular, tonic extension that could be associated with a GTC seizure. The System records and stores sEMG data for subsequent review by a trained healthcare professional.
15921695|NCT03484585|Drug|Rogaratinib (BAY1163877)|Single dose, intake orally, 200 mg
15921696|NCT03484572|Diagnostic Test|Anthropometric measures|Weight (kg),Height (cm)Body mass index(kg/m²),Mid-upper arm-circumference(cm), tricipital skinfold (cm)
15921697|NCT03484546|Procedure|laparoscopic endometrioma cyst excision|laparoscopic resection of ovarian endometrioma
15921698|NCT03484533|Behavioral|HIV self-test kit|We will conduct a randomized trial to evaluate whether provision of oral HIV self-test kits to HIV-positive pregnant women overcomes their male partners' reluctance to be tested in PMTCT clinics. Pregnant women who are randomized to the HIVST arm will be trained in the use and interpretation of HIVST, and given two oral fluid-based HIVST kits to use with or give to their partners, along with information about HIV testing and prevention and care services. We will offer men confirmatory testing regardless of their HIV test result through HIVST, counseling, and if negative, PrEP and if positive, ART.
15921699|NCT03484533|Behavioral|Standard of Care|In the standard of care arm, we will give women invitation letters to deliver to their male partners to come to the ANC clinic for fast-tracked HIV testing. We will offer men counseling and if negative, PrEP and if positive, ART.
15921700|NCT03484520|Drug|Venetoclax|tablet, oral
15921701|NCT03484520|Drug|Dinaciclib|intravenous
15921702|NCT03484507|Drug|Chlorhexidine|1 drop half-hourly for days 1-2, then hourly for days 3-6, then 8 times daily until the 4-week visit
15921703|NCT03484507|Drug|Povidone-Iodine|1 drop half-hourly for days 1-2, then hourly for days 3-6, then 8 times daily until the 4-week visit
15921704|NCT03484507|Drug|Prednisolone Sodium Phosphate|1 drop 4 times daily for weeks 4-9, then 2 times daily for weeks 10-11
15921705|NCT03484507|Drug|Hydroxypropyl Methylcellulose|1 drop 4 times daily for weeks 4-9, then 2 times daily for weeks 10-11
15921706|NCT03484507|Drug|Prednisolone Sodium Phosphate|1 drop 4 times daily for weeks 6-9, then 2 times daily for weeks 10-11
15921707|NCT03484507|Drug|Hydroxypropyl Methylcellulose|1 drop 4 times daily for weeks 4-5
15921708|NCT03484494|Device|Low Field Magnetic Stimulation|Low Field Magnetic Stimulation is an application of a series of electromagnetic pulses to the brain through a small cylinder that the subject places the top of their head inside.
15921709|NCT03484481|Dietary Supplement|Oral Nutritional Support; Nutrena|Patients in group 1 and 3 take ONS 200 ml/day twice a day at home. Patients in group 2 and 3 received IDPN administrations. ]. Its infusion was started 30 minutes after initiation of HD via the venous port of the bubble trap on the HD tubing and continued throughout the entire HD procedure at a rate of 150 ml/h for 30 min and consisted of 300 ml for 3 hour.
15921710|NCT03484481|Dietary Supplement|Intradialytic Parenteral Nutrition; Kabiven central|Patients in group 2 and 3 received IDPN administrations Its infusion was started 30 minutes after initiation of HD via the venous port of the bubble trap on the HD tubing and continued throughout the entire HD procedure at a rate of 150 ml/h for 30 min and consisted of 300 ml for 3 hour.
15921711|NCT03484468|Device|anterior segment Ocular Coherence Tomography|anterior segment OCT (Ocular Coherence Tomography) a device shows imaging of anterior segment of the eye and able to show corneal layers and measures its thickness.
15921712|NCT03484455|Device|Hypothermic machine perfusion|Organ Recovery Systems LifePort® Liver Transporter (LLT) System and Vasosol® Machine Perfusion Solution
15921713|NCT03484455|Device|Static cold storage|Static cold storage (standard of care)
15921714|NCT03484429|Device|Peripheral nerve stimulation|Up to 60 days of peripheral nerve stimulation
15921715|NCT03484429|Other|Standard Medical Therapy|Medications, physical therapy, or other pain treatments
15921716|NCT03484416|Drug|Calcium Carbonate 1500 Mg with Vitamin D|Patients in the routine calcium group received oral supplements of 1,500 mg/day elemental calcium and 1,000 IU/day cholecalciferol (Dicamax 1000) for 2 weeks, whereas control group did not
15921717|NCT03484403|Other|Lumbar back brace|A brace that supports the lumbar region of the spine.
15921718|NCT03484403|Behavioral|Back school|Back school consists of patient education physical therapy exercise instruction.
15921719|NCT03484390|Behavioral|Mindfulness-based stress reduction|
15921720|NCT03484390|Behavioral|Wellness Group|
15921721|NCT03484377|Device|Anodal tDCS|The experimental condition will use a constant current of 2mA for 20 minutes, delivered via gradual increase and decrease over 10 seconds at the onset and offset of stimulation (current ramps), respectively.
15921722|NCT03484377|Device|Sham tDCS|The anodal electrode will be placed over the supreorbital ridge. The current will be delivered only in the first 10 seconds, after which the stimulation will cease but with the electrodes still in place throughout the session. The session will last for 20 minutes.
15921723|NCT03484364|Behavioral|ENACTS|Peer-facilitated, self-care BP education delivered weekly for 8 weeks emphasizing healthy diet, traditional NHPI foods, adherence to medication, and encouragement to increase physical activity and stop smoking, with text messaging to boost adherence. $30 of groceries for 8 weeks.
15921724|NCT03484351|Other|Fall Monty Activity Programme (FallMAP)|The programme delivered during this feasibility study will consist of a total of 12 multifactorial falls prevention group exercise sessions of 90-100 minutes in duration, followed by a 20-30 minute social activity. The sessions will be offered over a period of 8 weeks. Each session will comprise (a mix of) seven program components of the intervention: 1) falls prevention education, 2) FaME group-based exercises for strength and dynamic balance, 3) (Preparing for) home exercises, 4) Interactive, virtual reality gamefied exercises, 5) Getting on and off the floor / floorwork / safe landing & falls technique activities, 6) Home falls hazard evaluation and 7) A social activity after the exercise session.
15921725|NCT03484338|Behavioral|Accelerated Resolution Therapy|ART is an evidence-based therapy for the treatment of depressive symptoms and trauma and stress-related disorders that includes the core components of trauma-focused therapy including imaging rescripting, voluntary image replacement, guided visualization with use of eye movements, desensitization and processing of distressing memories, and in-vitro exposure to future feared triggers
15921726|NCT03484299|Procedure|Irreversible Electroporation (IRE)|Non-thermal ablation of tumor
15921727|NCT03484299|Drug|Gemcitabine|25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled
15921728|NCT03484299|Drug|FOLFIRINOX|25% dose - first 3 enrolled; 50% dose - next 3 enrolled; 75% dose - remaining 4 enrolled
15921729|NCT03484286|Device|OPTILOGG|"OPTILOGG is a CE marked class 1m medical device. It consists of a tablet computer and a wirelessly connected weight scale. The system will have some patient specific information regarding the flexible (loop-) diuretics scheme.
~The patient will be asked to step on the weight scale daily, and will be shown to some brief information on how to live better with HF, as well as the recommended dose of diuretics that specific day. Every five days the patient will answer three questions about his/her symptoms, namely shortness of breath, fatigue and peripheral edema. The system also contains information that the patient can study at his/her leisure. If the system detects a deterioration in HF status, the patient is encouraged to contact his/her health care provider via telephone."
15921730|NCT03484286|Other|Standard care|Patients in the control group will be subject to standard heart failure care.
15921732|NCT03484260|Drug|Testosterone Product|Men used testosterone product following prescription
15921733|NCT03484247|Other|Infraclavicular brachial plexus block|Infraclavicular block will be performed with ultrasound guidance and peripheric nerve stimulator. Local anesthetic will be administered after aspiration, via peripheric nerve needle according to mentioned technique ( https://www.nysora.com/)
15921734|NCT03484247|Other|axillary brachial plexus block|Axillary nerve block will be performed with ultrasound guidance and peripheric nerve stimulator. Local anesthetic will be administered after aspiration via peripheric nerve needle according to mentioned technique ( https://www.nysora.com/)
15921735|NCT03484234|Device|Ultimaster stent|Percutaneous coronary intervention with Ultimaster stent for long lesion
15921736|NCT03484234|Device|Xience alpine stent|Percutaneous coronary intervention with Xience alpine stent for long lesion
15921737|NCT03484221|Drug|FOLFOXIRI|IRINOTECAN 150 mg/m^2 IV over 1-h, day 1 + OXALIPLATIN 85 mg/m^2 IV over 2-h, day 1 + L-LEUCOVORIN 200 mg/m^2 IV over 2-h, day 1 + 5-FLUOROURACIL 2800 mg/m^2 IV 48-h continuous infusion, starting on day 1 administered every two weeks for 4 cycles (2 months).
15921738|NCT03484221|Radiation|Short-Course Radiation Therapy(5Gy*5)|Patients received a short-course radiation therapy(5Gy*5) after 4 cycles of FOLFOXIRI.
15921739|NCT03484221|Drug|XELOX|OXALIPLATIN 130 mg/m^2 IV over 2-h, day 1 Capecitabine 1000 mg/m^2 twice daily days 1-14 every 3 weeks for 4 cycles.
15921740|NCT03484208|Other|osteoporotic fracture liaison service|a specific nurse calls patient and propose them to follow the osteoporotic fracture liaison service
15921741|NCT03484195|Drug|FOLFOXIRI|Irinotecan 150 mg/m^2 IV over 1h, day 1 + Oxaliplatin 85 mg/m^2 IV over 2h, day 1 + L-Leucovorin 200 mg/m^2 IV over 2h, day 1 + 5-Fluorouracil 2800 mg/m^2 IV 48h continuous infusion, starting on day 1 administered every two weeks for 4 cycles (2 months)
15921742|NCT03484182|Behavioral|Web-based Home Exercise Program|Home exercises that are guided by a web-based program
15921743|NCT03484182|Behavioral|Standard Home Exercise Program|Standard paper-based home exercise program
15921779|NCT03483909|Device|left IFG iTBS|15 daily sessions of intermittent theta burst stimulation at 80% resting motor threshold, total duration of 190 s, localization using EEG 10/20 system at F3/F4
15921904|NCT03482973|Other|Placebo|20cc placebo (0.9% NaCl) will be administered on each side at two different time points (immediately post operatively and on day 1).
15921744|NCT03484169|Other|intervention group|"The training of PNF pelvic patterns for motor learning in GI will be performed twice a week by a trained and experienced researcher for six weeks (CHRISTIANSEN et al., 2017). At each training session, there will be three repeated movements in each pelvic pattern:
~Combination of isotonic (concentric, stabilizing and eccentric) of the anterior elevation pattern; Combination of isotonic (concentric, stabilizing and eccentric) of the posterior depression pattern; Combination of isotonic (concentric, stabilizing and eccentric) of the previous depression pattern; Combination of isotonic (concentric, stabilizing and eccentric) of the posterior elevation pattern;"
15921745|NCT03484156|Device|Installation of 3PEGASE Sensor|Volunteers will be equipped with the 3-PEGASE solution to monitor clinical indicators at home : By assessing older person's autonomy at home and detecting early infra-clinical indicators, the solution could provide relevant clinical parameters to the caregivers and healthcare professionals in order to support the patient's follow-up, and support the detection of preliminary signs of functional loss
15921748|NCT03484130|Dietary Supplement|Sodium loaded diet|At baseline, and annually, participants will undergo aldosterone dynamic testing after ~5 days of a sodium loaded diet. The diet will consist of >180 mmol/day of sodium, ~50 mmol/day of potassium, and 600mg/d of calcium.
15921749|NCT03484130|Dietary Supplement|Restricted sodium diet|At baseline, and annually, participants will undergo aldosterone dynamic testing after ~5 days of a sodium restricted diet. The diet will consist of <40 mmol/day of sodium, ~50 mmol/day of potassium, and 600mg/d of calcium.
15921750|NCT03484117|Behavioral|Community Health Worker|Participants will receive 5 one-on-one sessions with a CHW over 24 weeks.
15921751|NCT03484104|Diagnostic Test|Measurement of tissue oxygenation index (TOI)|TOI and Vmca measurement during cardiac surgery with hypothermic circulatory arrest
15921752|NCT03484091|Drug|Hyruan-One|single dose intra-articular injection
15921753|NCT03484091|Drug|Hylan G-F 20|single dose intra-articular injection
15921754|NCT03484091|Drug|Normal saline|single dose intra-articular injection
15921755|NCT03484078|Device|Vibration Platform|The vibration platform will emit a mild vibration when the participant stands on it 10 minutes per day for 6 months.
15921756|NCT03484078|Device|Placebo Platform|The placebo platform will not vibrate when the participant stands on it 10 minutes per day for 6 months.
15921757|NCT03484065|Other|Questionnaire quality of life|
15921758|NCT03484052|Other|Jugular ultrasound|Performing a jugular ultrasound by 2 operators before and after transfusion
15921759|NCT03484039|Behavioral|Medication Adherence|Some subjects will be enrolled in a medication adherence course.
15921760|NCT03484039|Behavioral|Seizure Documentation|Some subjects will be enrolled in a seizure documentation course.
15921761|NCT03484039|Behavioral|Memory Improvement|Some subjects will be enrolled in a memory improvement course.
15921762|NCT03484039|Behavioral|Stress Management|Some subjects will be enrolled in a stress management course.
15921763|NCT03484026|Dietary Supplement|BioFe|BioFe Medical Food is comprised of cultured nutritional/Baker's yeast (Saccharomyces cerevisiae) with high levels of Ferritin/Iron complex, pasteurized, and dried
15921764|NCT03484000|Behavioral|Online Mindfulness Based Cancer Recovery (MBCR)|MBCR is a group behavioral treatment that trains participants in mindfulness techniques through meditation and gentle mindful movement
15921765|NCT03483987|Drug|Sof+Ledi+R arm|Fixed dose combination of sofosbuvir 400 mg plus ledipasvir 90 mg once daily plus ribavirin 1000 mg (body weight <75 kg) or 1200 mg (body weight =>75 kg) daily in two divided doses
15921766|NCT03483987|Drug|Sof+Ledi+R+Peg-IFN arm|Fixed dose combination of sofosbuvir 400 mg plus ledipasvir 90 mg once daily plus ribavirin 1000 mg (body weight <75 kg) or 1200 mg (body weight =>75 kg) daily in two divided doses plus pegylated interferon alpha 2b @ 1.5 microgram/kg subcutaneously once in a week
15921767|NCT03483987|Drug|Sof+Dacla+R arm|Sofosbuvir 400 mg once daily plus daclatasvir 100 mg once daily plus ribavirin 1000 mg (body weight <75 kg) or 1200 mg (body weight =>75 kg) daily in two divided doses
15921768|NCT03483987|Drug|Sof+Dacla+R+Peg-IFN arm|Sofosbuvir 400 mg once daily plus daclatasvir 100 mg once daily plus ribavirin 1000 mg (body weight <75 kg) or 1200 mg (body weight =>75 kg) daily in two divided doses plus pegylated interferon alpha 2b @ 1.5 microgram/kg subcutaneously once in a week
15921769|NCT03483987|Drug|Sof+Velpa+R arm|Fixed dose combination of sofosbuvir 400 mg plus velpatasvir 100 mg once daily plus ribavirin 1000 mg (body weight <75 kg) or 1200 mg (body weight =>75 kg) daily in two divided doses
15921770|NCT03483987|Drug|Sof+Velpa+R+Peg-IFN arm|Fixed dose combination of sofosbuvir 400 mg plus velpatasvir 100 mg once daily plus ribavirin 1000 mg (body weight <75 kg) or 1200 mg (body weight =>75 kg) daily in two divided doses plus pegylated interferon alpha 2b @ 1.5 microgram/kg subcutaneously once in a week
15921771|NCT03483974|Diagnostic Test|hyperspectral imaging|using hyperspectral detector for evaluation excreta pattern
15921772|NCT03483961|Biological|CHIKV VLP/unadjuvanted|Vaccine consists of virus-like particles of chikungunya virus antigens
15921773|NCT03483961|Biological|CHIKV VLP/adjuvanted|Adjuvanted formulation includes Alhydrogel
15921774|NCT03483961|Biological|Placebo|Placebo is vaccine diluent alone
15921775|NCT03483948|Drug|HMPL-523|HMPL-523 tablet
15921776|NCT03483948|Drug|Azacitidine|Azacitidine Injection
15921777|NCT03483935|Other|Microwave treatment|Microwave energy delivered using the microwave instrument, SWIFT, manufactured by Emblation and CE marked for dermatology applications.
15921778|NCT03483922|Diagnostic Test|ctDNA methylation in and it's Correlation wth Development and prediction of HCC|Blood sample from patients with HCC, healthy individuals and individuals with hepatitis B will be collected, and DNA will extracted from PBMC and circulated tumor DNA will be subjected to bisulfite conversion. DNA from PBMC DNA will be analyzed with primers developed for the AHNAK-STAP1 genes. Plasma samples will be subjected to EZ direct DNA extraction and bisulfite conversion kit and will be amplified with primers developed to amplify the target regions. DNA will be used for the subsequent PCR amplification with specific primer to generate PCR amplicon for sequencing using a double PCR procedure. The product of PCR reaction will be subjected to indexed MiSeq Next-Generation sequencing that will allow us quantify DNA methylation level.
15922167|NCT03480776|Drug|Acetylsalicylic acid|81 mg PO daily or 325 mg PO daily
15921780|NCT03483909|Device|right IPL cTBS|15 daily sessions of continuous theta burst stimulation at 100% resting motor threshold, total duration of 45 s, localization using EEG 10/20 system at F3/F4
15921781|NCT03483909|Device|Placebo|rTMS with a placebo coil that looks identical and makes identical noises for 180 s, localization over left IPL
15921782|NCT03483896|Other|Daylight Intervention|Staff increased the daylight exposure of participants by taking them to the perimeter zone of a daylit room from 8:00 to 10:00 AM for socialization over a period of 12 weeks. The perimeter zone was defined to be the region of the room within 3 meters from windows. The intervention was administered each day (7 days / week) over the duration of the study.
15921783|NCT03483883|Drug|Avelumab|Avelumab IV 10 mg/kg every 2 weeks
15921784|NCT03483883|Drug|Gemcitabine|Dose Level 1: Gemcitabine 1250 mg/m2 IV every 2 weeks Dose Level 2: 1500 mg/m2 IV every 2 weeks
15921785|NCT03483870|Drug|Morphine Sulfate|200 ug morphine sulphate will be injected intrathecally
15921786|NCT03483870|Drug|Placebo|2 mL of normal saline 0.9% IV injection
15921787|NCT03483870|Drug|Granisetron|2 mL of 2 mg granisetron IV injection
15921788|NCT03483857|Behavioral|Peer Navigation|Utilizing Peer Navigators for HIV-Positive MSM for increase in uptake along the continuum.
15921789|NCT03483844|Diagnostic Test|GE CT 750 HD|Low-dose dual-energy CT imaging
15921790|NCT03483831|Behavioral|Intervention group|Refillable water dispensers will be placed in each class of the intervention group to facilitate water access: every class will receive 5 bottles (18 Liters/each) per week for a total of 5 months. Every student will receive a re-usable water bottle.
15921791|NCT03483818|Procedure|Assessment & Treatment of HCV infection with oral antivirals|This is a cluster randomised trial of directly observed anti HCV therapy versus conventional care in HCV positive patients, who are in a pharmacist delivered OST program, where the patients attending an individual pharmacist are the cluster. Pharmacies participating in the trial will be allocated to conventional care pathway or the pharmacist-led pathway.
15921792|NCT03483805|Dietary Supplement|Protalsafe|mix of prebiotic, probiotic and plant extract in powder form, to be diluted in water
15921793|NCT03483805|Dietary Supplement|Placebo|maize maltodextrin in powder form, to be diluted in water
15921794|NCT03483792|Biological|Plasma dosage|4 x 7 ml of blood punction at each control visit of the three trimesters of pregnancy
15921795|NCT03483792|Genetic|placental biopsy|Immediately following delivery (<12h postpartum), placental biopsies (Collection of 4 placental fragments)
15921796|NCT03483779|Drug|Ginkgo biloba pills|Each N-of-1 trial will consist of 6 treatment periods, of which 2 treatment periods are in one group, including 8 weeks of placebo treatment and 8 weeks of ginkgo biloba pills.
15921797|NCT03483779|Drug|placebo pills|Each N-of-1 trial will consist of 6 treatment periods, of which 2 treatment periods are in one group, including 8 weeks of placebo treatment and 8 weeks of ginkgo biloba pills.
15921798|NCT03483766|Device|Robotic Functional Rehabilitation system|The tailored-made EMG driven soft-robotic hand prosthesis for tetraplegia individuals may help to preserve the residual function and to enhance the functional recovery.
15921799|NCT03483753|Drug|Vasopressin|"Blinded Vasopressin will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement.
~Continuous infusion of the drug at doses ranging from 0.01 U / min to 0.06 U / min"
15921800|NCT03483753|Drug|Norepinephrine|Blinded Norepinephrine will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement. Continuous infusion of the drug at doses ranging from 0.1 mcg / kg / min to 1.0 mcg / kg / min.
15921801|NCT03483740|Behavioral|CRGT|Cognitive remediation group therapy (CRGT) will be comprised of 1/3 brain training exercises on tablets using PositScience software by BrainHQ and 2/3 mindfulness-based stress reduction (MBSR) involving various activities such as meditation, breathing exercises, etc. Intervention will comprise of 8 weekly 3-hour sessions.
15921802|NCT03483740|Behavioral|HIV group therapy|These groups use a model of mutual aid to encourage peer-based discussion on the effects of living with HIV. Topics are determined by the group; facilitators ensure that safety is maintained throughout and make connections between participants as appropriate. Intervension will comprise of 8 weekly 3-hour sessions.
15921803|NCT03483727|Device|SIMMAXMARCHERYAN|Digital cognitive aid during the management of simulated combat wounded.
15921804|NCT03483714|Procedure|Spinal Manipulation|HVLA (High Velocity Low Amplitude) spinal manipulation directed at the lumbar spine and sacroiliac (SI) joints
15921805|NCT03483701|Behavioral|Cognitive Remediation Therapy|The intervention of interest for participants in the experimental group is the addition of up to 5 hours per week of computerized cognitive exercises. Cognitive training can be done at home on a computer. For participants without access to a computer, a laptop/tablet computer with the necessary software will be provided for the duration of training. Participants will be able to complete the cognitive exercises on their own schedule, with participation verified by the software. Participants will also receive 1 hour/week of individual coaching to discuss cognitive remediation progress, e.g. to learn about different cognitive domains and develop ways to generalize their cognitive remediation gains.
15921806|NCT03483688|Biological|CD19-directed CAR-T cells|CD19-directed CAR-T cells single infusion intravenously at a target dose of 0.5-5.0 x 10^6 anti-CD19 CAR+ T cells/kg
15921807|NCT03483675|Biological|Immunosuppressive Therapy|Discontinued IST
15921808|NCT03483675|Biological|Immunosuppressive Therapy|Continued IST
15921809|NCT03483675|Other|Survey Administration|Ancillary studies
15921810|NCT03483662|Behavioral|Multicomponent Intervention|The core component of the intervention is protocol-based treatment using the SPRINT BP management algorithm. The following implementation strategies are adaptable components that will be modified to fit specific federally-qualified health center (FQHC) settings: dissemination of SPRINT study findings among provider-teams, patients, and administrators, team-based collaborative care, BP audit and feedback, home BP monitoring, and health coaching on antihypertensive medication adherence and lifestyle modification.
15921811|NCT03483662|Behavioral|Enhanced Usual Care|The investigators will provide an up-to-date clinical guideline for hypertension management to providers. A webinar education session on the new American College of Cardiology (ACC)/American Heart Association (AHA) hypertension guideline and findings from the SPRINT trial will be conducted. Otherwise, the investigators will not conduct any active intervention and all control clinics will follow their routine clinic practice in the management of hypertensive patients
15921812|NCT03483649|Drug|HLX04|HLX04: Supplied as 100 mg/4 mL solution; reconstituted to 100 mL with 0.9% sodium chloride; a single dose of 3 mg/kg will be administered intravenously for 90 minutes.
15921813|NCT03483649|Drug|US-Avastin®|US Avastin®: Supplied as 100 mg/4 mL solution; reconstituted to 100 mL with 0.9% sodium chloride; a single dose of 3 mg/kg will be administered intravenously for 90 minutes.
15921814|NCT03483649|Drug|EU-Avastin®|EU-Avastin®: Supplied as 100 mg/4 mL solution; reconstituted to 100 mL with 0.9% sodium chloride; a single dose of 3 mg/kg will be administered intravenously for 90 minutes.
15921815|NCT03483649|Drug|CN-Avastin®|CN-Avastin®: Supplied as 100 mg/4 mL solution; reconstituted to 100 mL with 0.9% sodium chloride; a single dose of 3 mg/kg will be administered intravenously for 90 minutes.
15921816|NCT03483636|Drug|Lemborexant|Film-coated oral tablet
15921817|NCT03483636|Drug|Alcohol|0.6 g/kg (female) or 0.7 g/kg (male) of 40% ethanol (volume per volume) vodka diluted in a low-calorie beverage (e.g., cranberry beverage), for a total volume of 300 mL (approximately 150 mL per aliquot).
15921818|NCT03483636|Drug|Placebo|Film-coated oral tablet
15921819|NCT03483623|Other|NATO WELP combination|Interface pressure will be measured using the XSensor X3 Pressure Mapping System. Transducers will be placed near both scapula. Measures will be obtained in upright (baseline) and supine positions on 4 randomly assigned litter mattress combinations. Constant TCPO2 measures, as well as peak pressures and total body surface area exposed to skin will be measured for the occiput, sacrum, both scapula, buttocks and heel areas. It will take about 20 minutes for each combination. The session is complete after all measures have been obtain for all litter/mattress combinations.
15921820|NCT03483623|Other|NATO FIS combination|Interface pressure will be measured using the XSensor X3 Pressure Mapping System. Transducers will be placed near both scapula. Measures will be obtained in upright (baseline) and supine positions on 4 randomly assigned litter mattress combinations. Constant TCPO2 measures, as well as peak pressures and total body surface area exposed to skin will be measured for the occiput, sacrum, both scapula, buttocks and heel areas. It will take about 20 minutes for each combination. The session is complete after all measures have been obtain for all litter/mattress combinations.
15921821|NCT03483623|Other|RAVEN WELP combination|Interface pressure will be measured using the XSensor X3 Pressure Mapping System. Transducers will be placed near both scapula. Measures will be obtained in upright (baseline) and supine positions on 4 randomly assigned litter mattress combinations. Constant TCPO2 measures, as well as peak pressures and total body surface area exposed to skin will be measured for the occiput, sacrum, both scapula, buttocks and heel areas. It will take about 20 minutes for each combination. The session is complete after all measures have been obtain for all litter/mattress combinations.
15921822|NCT03483623|Other|RAVEN FIS combination|Interface pressure will be measured using the XSensor X3 Pressure Mapping System. Transducers will be placed near both scapula. Measures will be obtained in upright (baseline) and supine positions on 4 randomly assigned litter mattress combinations. Constant TCPO2 measures, as well as peak pressures and total body surface area exposed to skin will be measured for the occiput, sacrum, both scapula, buttocks and heel areas. It will take about 20 minutes for each combination. The session is complete after all measures have been obtain for all litter/mattress combinations.
15921823|NCT03483610|Behavioral|Provider Referral|Participants will be asked if they are up-to-date on their cervical cancer screening. If not they will be referred to a provider. At the end of the study they will receive a 10 minute follow up telephone survey to collect data screening status and views on cervical cancer screening.
15921824|NCT03483610|Behavioral|Text Messaging|Participants will be asked if they are up-to-date on their cervical cancer screening. If not they will be referred to a provider. They will also receive a total of 3 text messages at 30-day intervals encouraging follow-up for cervical cancer screening. They will receive a 10 minute follow up telephone survey to collect data screening status and views on cervical cancer screening.
15921825|NCT03483597|Other|TSQM-II|Treatment Satisfaction Questionnaire for Medication (TSQM Version II) will be used in all groups
15921826|NCT03483558|Other|Control|A standardized diet without any vegetables was provided.
15921827|NCT03483558|Other|Spinach|A standardized diet with 200g spinach was provided.
15921828|NCT03483558|Other|Celery|A standardized diet with 200g celery was provided.
15921829|NCT03483558|Other|Onion|A standardized diet with 200g onion was provided.
15921830|NCT03483558|Other|Mixed Vegetables|A standardized diet with 200g of mixed vegetables (spinach, celery, and onion) was provided.
15921831|NCT03483545|Combination Product|Follitropin delta and HP-hMG|Follitropin delta dose will be determined by AMG and weight in Kg. Highly purified human menopausal gonadotrophin will be determined by follitropin delta dose and body weight in Kg
15921832|NCT03483532|Dietary Supplement|Lit Control pH Up|dietary supplement based on citrate, saponins, magnesium, zinc and vitamin A
15921833|NCT03483532|Dietary Supplement|dry cocoa extract|(Theobroma cacao, fruit), 2 capsules of 750 mg per individual, dosed at a rate of one during the breakfast and another during dinner.
15921834|NCT03483519|Other|Rehabilitation|Patients randomized to the Experimental Group will undergo a 6 Week Exercise Program plus Standard of Care
15921835|NCT03483519|Other|Standard of Care|Patients randomized to the Active Comparator Group will not undergo an exercise program, patients will receive the standard of care used at The Ottawa Hospital for hip and knee surgeries. Standard of care protocol will be explained by each individual surgeon.
15921836|NCT03483506|Drug|BI 1467335|Film-coated tablet
15921837|NCT03483506|Drug|BI 1467335 (C-14) intravenous solution|Intravenous solution
15921838|NCT03483493|Behavioral|Exposure Response Prevention for tics|The intervention consists of evidence-based interventions adapted from previously published treatment manuals on Exposure and Response Prevention (ERP) and established behavioural intervention for tics protocols. Each of the 10 modules includes age-appropriate texts, animations and exercises. Prticipants are instructed to practice suppressing their tics, this is known as 'response prevention'. Then, with the help of their parent/carer, the participant is instructed to provoke premonitory urges (the urge to tic often felt before the tic is expressed) and try to supress the need to express/demonstrate the tic, this known as 'exposure'.
15921897|NCT03483038|Drug|FOLFOX regimen|Subjects will receive FOLFOX (oxaliplatin 60 mg/m2 IV, leucovorin 400 mg/m2 IV, and 5-fluorouracil 2400 mg/m2 IV) on Day 1 of each 14 day cycle.
15921898|NCT03483025|Other|Skin Testing of Hair cleansing products|6 different commercially available shampoos
15921839|NCT03483493|Other|Psychoeducation for tics|The comparator intervention reviews the definition of tics, natural history, common presentations, prevalence, aetiology, risks and protective factors and strategies for describing tics to other people etc. Problem-solving and development of expertise in tic disorders is emphasised. The intervention includes strategies for promoting positive behaviours which will be rewarded by a parent as a parallel element to the tic control practice in the behavioural therapy arm. There is no information on tic control within the management package.
15921840|NCT03483480|Procedure|NPWT for Pilonidal Surgery|After excision of pilonidal sinus Non powered-NPWT will be applied to the area
15921841|NCT03483480|Procedure|Excision of Pilonidal sinus with normal dressing|After excision of pilonidal sinus normal dressing will be applied to the area of surgery
15921842|NCT03483467|Other|Omnigen|For those randomised onto the investigational arm, a dual layer of the Omnigen product will be applied at baseline and at every fortnightly trial visit until healing or the end of the 12 week period whichever occurs first, according to the standard study procedure.
15921843|NCT03483467|Other|Dummy Packaging|For those randomised into the control arm, dummy packaging will be opened at the time of application of standard of care, to ensure the same experience is received to those on the experiential arm.
15921844|NCT03483454|Other|Exercise class|Same as above.
15921845|NCT03483454|Other|Home exercise|Same as above.
15921846|NCT03483428|Behavioral|Interventionist training and supervision|"Online and in-person training and weekly supervision with licensed clinical social worker while delivering the Family Check-Up to 5 families."
15921847|NCT03483428|Behavioral|Behavioral parent training|"Up to 6 sessions of the Family Check-Up program, involving discussions, assessments, feedback, and skills training with a parent coach."
15921848|NCT03483415|Drug|Morphine Sulfate|Intravenous morphine infusion with PCA: Solution was concentration of 0.5 mg/mL. Loading dose of 1 mg, 0.5 mg of bolus dose and 20 min of locking time.
15921849|NCT03483415|Drug|Bupivacaine|Ultrasound guided Long thoracic nerve blockage with 5 ml % 0.25 bupivacaine
15921850|NCT03483402|Procedure|Micropulse laser trabeculoplasty|Micropulse laser trabeculoplasty is performed using the Iridex IQ 532 laser system (Iridex Corporation, 1212 Terra Bella Avenue, Mountain View, CA, USA) and 532 nm (green) wavelength MLT is applied with confluent applications to pigmented trabecular meshwork over 360 degrees using a 300 µm spot size, 300 ms duration, 1000 mW power and 15% duty cycle.
15921851|NCT03483389|Drug|Alcohol, Ethyl|Randomized within-subjects design
15921852|NCT03483389|Other|Alcohol, Ethyl - placebo|Randomized within-subjects design
15921853|NCT03483376|Procedure|Dental prophylaxis|Determining the effectiveness of dental prophylaxis alone in eliminating dental black stain.
15921854|NCT03483376|Device|Antimicrobial photodynamic therapy (aPDT)|Establishing the effectiveness of dental prophylaxis combined with antimicrobial photodynamic therapy using blue light and curcumin as the photosensitizing agent in eliminating dental black stain.
15921855|NCT03483363|Drug|topical irrigation with the antibiotic bacitracin|Fractures will be irrigated with Bacitracin topical antibiotic (50,000 units) prior to closure.
15921856|NCT03483363|Drug|topical irrigation with sterile normal saline (NS)|Fractures will be irrigated with sterile normal saline prior to closure. All groups with receive standard parenteral (IV) prophylactic antibiotic.
15921857|NCT03483363|Drug|intravenous (IV) prophylactic antibiotic|All groups with receive standard parenteral (IV) prophylactic antibiotic.
15921858|NCT03483350|Drug|Granisetron|Ampoule
15921859|NCT03483350|Drug|Midazolam|Ampoule
15921860|NCT03483337|Other|MRI examinations|Patients will be imaged on a 1.5 T or 3 T MR scanner either from GE or Philips. Patients will receive a test-retest scan in on session prior to start of treatment. Patients who will be receiving radiation therapy treatment at main campus, will also be imaged weekly during their course of treatment.
15921861|NCT03483337|Other|MRI examinations|Patients will be imaged on a 1.5 T or 3T MR scanner within one week prior to treatment initiation and at two months and four months after treatment completion (+/- 1 week).
15921862|NCT03483324|Biological|Unmanipulated Umbilical Cord Blood (UCB)|Human leukocyte antigen (HLA) matched umbilical cord blood
15921863|NCT03483324|Biological|AB-110|Expanded cord blood stem cells and engineered human endothelial cells
15921864|NCT03483311|Other|skin biopsy before and after NB-UVB phototherapy|skin biopsy before and after NB-UVB phototherapy to measure tissue resolvin D1
15921865|NCT03483298|Other|ICSI|The cryopreserved pre-TESA ejaculate and TESA specimen will be thawed on the day of oocyte retrieval per protocol for ICSI
15921866|NCT03483285|Device|airtraq|airtraq videolaryngoscope
15921867|NCT03483285|Device|storz|storz videolaryngoscope
15921868|NCT03483259|Drug|Sulfatinib T capsule|Sulfatinib T capsules were produced by Hutchison Whampoa Pharmaceutical (Suzhou) Co., Ltd. production.
15921869|NCT03483259|Drug|Sulfatinib R capsule|Sulfatinib R capsules were produced by Beijing Yiling Bioengineering Technology Co., Ltd.
15921872|NCT03483233|Other|fMRI and EEG study|fMRI and EEG study
15921899|NCT03483012|Drug|Atezolizumab|Atezolizumab is a protein that affects your immune system by blocking the PD-L1 pathway
15921900|NCT03483012|Procedure|Stereotactic radiosurgery (SRS)|Stereotactic radiosurgery (SRS) is a standard procedure used to treat patients with cancer in the brain. SRS uses many precisely focused radiation beams to treat tumors
15921901|NCT03482999|Device|TissuGlu Surgical Adhesive|
15921902|NCT03482986|Behavioral|Dietary habits plan|Patients will be given a personalized plan regarding their diet.
15921903|NCT03482973|Drug|Bupivacaine Group|20cc bupivacaine hydrochloride will be administered on each side at two different time points (immediately post operatively and on day 1).
15921873|NCT03483220|Diagnostic Test|MRI brain|"Addiction severity index 4th version for assessment of addiction pattern.
~UPPS-P Impulsive Behavior Scale is a 59-item inventory designed to measure five distinct personality pathways to impulsive behavior: Negative Urgency, Lack of Perseverance, Lack of Premeditation, Sensation Seeking, and Positive Urgency.
~Iowa gambling task computerized version: The task involved drawing one card per trial from one of four decks (labeled as A, B, C, and D). Each deck contained 40 cards in a ﬁxed sequence which is unknown to participants at the start of the task. Next, participants are asked to select cards from the four decks to gain as much money as possible. The task ends when the 100th card is drawn, although subjects do not know this in advance.
~MRI brain examination:
~Voxel based morphometry through analysis of 3D T1 weighted sequence in order to assess total intracranial volume.
~Resting state functional MRI."
15921874|NCT03483207|Drug|Warfarin|Patients with confirmed diagnosis of acute MVT but having no signs of bowel infarction will be treated conservatively with anticoagulation (heparin &warfarin) In addition to usual care intravenous low molecular weight heparin will be started (IV bolus of 5000 IU followed by 1000 IU/hour with infusion pump) and the dose is adjusted to maintain APTT levels at 2-2.5 times the normal. followed by oral anticoagulation (warfarin) for 6 months or for life in the presence of coagulation abnormality. patients will be critically monitored for the progress of response of therapy .
15921875|NCT03483207|Procedure|MVT with failure of anticoagulation therapy|"patients managed conservatively with anticoagulation will be monitored for the progress of response of therapy , failure to improve or worsening in condition,will be an urgent indication for surgical intervention with resection of the infarcted bowel segment .If there is suspicion about the viability of remaining bowel intraoperative or later on based on clinical evidences,then second look laparotomy will be performed .The mortality and all complications associated with surgery will be recorded."
15921876|NCT03483207|Drug|Heparin|Patients with confirmed diagnosis of acute MVT but having no signs of bowel infarction will be treated conservatively with anticoagulation (heparin &warfarin) In addition to usual care intravenous low molecular weight heparin will be started (IV bolus of 5000 IU followed by 1000 IU/hour with infusion pump) and the dose is adjusted to maintain APTT levels at 2-2.5 times the normal. followed by oral anticoagulation (warfarin) for 6 months or for life in the presence of coagulation abnormality. patients will be critically monitored for the progress of response of therapy .
15921877|NCT03483194|Device|Virtual Reality|Bliss is a 3D Interactive application designed to meet the needs of escape and relaxation of people in isolation and / or stress and / or during painful care here osteo-medullary biopsy
15921878|NCT03483194|Drug|Kalinox|Usually take care of by a gas mixture composed of 50% Nitrous Oxide, 50% Oxygen for the medical procedure (osteo-medullary biopsy)
15921879|NCT03483181|Drug|Xarelto (rivaroxaban)|An oral anticoagulant medication for the prevention of VTE (Venous thromboembolism) related to orthopedic surgery. Patients received rivaroxaban during one day prior to or two days after orthopedic surgery during the hospitalization.
15921880|NCT03483181|Drug|Lovenox (enoxaparin)|An injectable anticoagulant medication for the prevention of VTE (Venous thromboembolism) related to orthopedic surgery. Patients received enoxaparin during one day prior to or two days after orthopedic surgeries during the hospitalization.
15921881|NCT03483168|Behavioral|Culturally sensitive pain education|The content of the PNE program include the characteristics of acute and chronic pain, purpose of acute pain, formation process of acute pain from the nervous system, the formation process of chronic pain, and potential sustaining factors for central sensitization.
15921882|NCT03483168|Behavioral|Standard pain education program|"For the standard translated PNE, The English translation of Pain Neuroscience Education: slides for supporting and illustrating your explanation at the Pain in Motion Group web page (http://www.paininmotion.be/education/tools-for-clinical-practice) and English translation of the Patient Information Leaflet will be used. The education materials will be translated using the forward/backward translation process. The English version of PNE presentation and information leaflet will be translated to Turkish by two independent translators."
15921883|NCT03483142|Drug|Misoprostol|( 25 patient): who will receive 400 microgram (tablet 200mcg X 2) misoprostol rectally one hour before operation
15921884|NCT03483142|Drug|Placebos|( 25 patient): who will receive placebo . two rectal placebo tablet of the same size and shape as the misoprostol
15921885|NCT03483129|Behavioral|Consultation|15 minute, one to one consultation with a trained practice nurse at a GP surgery. Participants will have the opportunity to discuss pre-diabetes, the risks of developing diabetes and the steps that can be taken to improve lifestyle behaviors and reduce the risk of diabetes development.
15921886|NCT03483116|Biological|RV3-BB|Oral administration
15921887|NCT03483116|Biological|Placebo|Oral administration
15921888|NCT03483103|Biological|lisocabtagene maraleucel|lisocabtagene maraleucel will be administered as a single dose intravenous (IV) injection
15921889|NCT03483090|Dietary Supplement|Swisse High Strength Deep Sea Krill Oil|Krill oil is sourced sustainably from the Southern Ocean and is extracted from the Antarctic Krill, the most abundant marine biomass. Krill oil is a source of omega-3 fatty acids, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) for the maintenance of good health. Omega-3, EPA and DHA are also found in phospholipid form which are much easier absorbed than triglyceride form of omega-3 which is found in fish oil. Omega-3 supports cardiovascular health, brain health and eye health. Preliminary research suggests krill oil can provide temporary relief from symptoms of mild arthritis, help reduce joint inflammation and increase joint mobility.
15921890|NCT03483090|Other|Placebo|No therapeutic effect
15921891|NCT03483077|Drug|BI 730460|tablets
15921892|NCT03483077|Drug|Placebo|tablets
15921893|NCT03483064|Other|Interferential current|interferential currents of 4,000 Hz carrier frequency, 100 Hz of AMF, for 20 minutes and with an amplitude up to the motor threshold
15921894|NCT03483051|Drug|Potassium Nitrate|Potassium nitrate capsules will consist of potassium nitrate (KNO3-) crystals [610 mg, corresponding to 6.03 mmoles of NO3-] with 190mg of lactose monohydrate, spray dried, NF. The dose for this trial will be 18 mmoles of NO3-per day, given as one capsule (6 mmoles) three times a day.
15921895|NCT03483051|Drug|Potassium Chloride|Potassium chloride capsules will consist of potassium chloride (KCl), granular, USP (450mg) plus lactose monohydrate, spray dried, NF (300mg). The dose for this trial will be 18 mmoles of KCl per day, given as one capsule (6 mmoles) three times a day.
15921896|NCT03483038|Drug|Liposomal Irinotecan|Subjects will receive 60 mg/m2 intravenously on Day 1 of each 14 day cycle.
15921905|NCT03482960|Drug|Hyperpolarized Xenon gas|"Hyperpolarized Xenon gas
~Hyperpolarized mixture (750ml HP 129Xe and 250ml nitrogen)
~Administration: By mouthpiece attached to a single use Tedlar bag.
~Dosage: 750 mL of the 129Xe mixture up to, but not exceeding, four doses of the 129Xe.
~Frequency: 10-minute interval between doses."
15921906|NCT03482960|Drug|PFP|"Inhaled PFP, a gaseous contrast agent (79% PFP; 21% O2, pre-mixed, medical grade gas)
~Administration: Full-face disposable ventilation mask and a standard Douglas Bag system.
~Dosage: Two controlled breaths of the contrast gas followed by a full breath and a 12-second breath-hold and scan for image acquisition.
~Frequency: Repeated 5 times followed by an identical five cycles with room air to ensure PFP gas wash-out has occurred."
15921907|NCT03482947|Drug|ultrasonography-guided TAP block|(1 mL/kg of bupivacaine 0.25% plus 1 μ/kg dexmedetomidine).
15921908|NCT03482947|Drug|Caudal epidural block|(1 mL/kg of bupivacaine 0.25% plus 1 μ/kg dexmedetomidine)
15921909|NCT03482934|Device|sphygmomanometer|device used for measurement of brachial blood pressure
15921910|NCT03482934|Device|mobilogragh|device used for measurement of central blood pressure
15921911|NCT03482934|Diagnostic Test|ECG|Electrocardiogram
15921912|NCT03482934|Diagnostic Test|Echocardiography|Echocardiography
15921913|NCT03482908|Behavioral|Early healthy lifestyles|Patient reported data to identify parenting practices and child behaviors associated with child's obesigenic risk in the future
15921914|NCT03482908|Behavioral|Responsive parenting curriculum|Information from the American Academy of Pediatrics Healthy Active Living for Families (HALF) program supplemented with messages from the INSIGHT study, that were written at the 5th grade reading level, with messages focused on 4 categories: 1) feeding the baby 2) soothing the baby 3) sleep health and 4) playing with the baby
15921915|NCT03482908|Behavioral|Data sharing/coordination|Data integration into child's electronic health record that is shared between settings (WIC and GHS PCPs) with display and documentation features that informs counseling.
15921916|NCT03482895|Biological|Blood sampling|Quantitative analysis of enterohormones, citrulline and ApoB48
15921917|NCT03482895|Biological|Feces sampling|Intestinal absorption assessment
15921918|NCT03482882|Drug|Pimavanserin|Pimavanserin 34 mg total daily dose, tablets, once daily by mouth (provided as two 17 mg NUPLAZID® tablets)
15921919|NCT03482869|Diagnostic Test|walking ability|Included patients will perform a 6 min walk test
15921920|NCT03482856|Behavioral|MNA plus CBT-I|MNA plus CBT-I includes 3 sessions (1 group, 1 online and 1 individual session) of therapeutic pain neuroscience education, 6 individual sessions of CBT-I and 9 individual sessions of time-contingent dynamic and functional cognition-targeted exercise therapy, combined with home exercises. CBT-I is the standard evidence-based care for treating chronic primary insomnia and typically includes changing negative thoughts about sleep, sleep hygiene, sleep restriction therapy, and teaching relaxation skills. The 18 sessions will be spread over a period of 14 weeks.
15921921|NCT03482856|Behavioral|MNA alone|MNA alone includes 3 sessions (1 group, 1 online and 1 individual session) of therapeutic pain neuroscience education, and 15 individual sessions of time-contingent dynamic and functional cognition-targeted exercise therapy, combined with home exercises. The 18 sessions will be spread over a period of 14 weeks.
15921922|NCT03482830|Procedure|Major emergency gastrointestinal surgery|"Open, laparoscopic, or laparoscopically-assisted procedures
~Procedures involving the stomach, small or large bowel, or rectum for conditions such as perforation, ischaemia, abdominal abscess, bleeding or obstruction"
15921923|NCT03482817|Drug|Ze 117|Subjects will be hospitalized to receive a probe drug cocktail alone and in combination with Ze 117.
15921924|NCT03482817|Drug|Probe drug cocktail|Subjects will be hospitalized to receive a probe drug cocktail alone and in combination with Ze 117.
15921925|NCT03482804|Other|Questionnaires|"Parents will be interviewed before being seen in consultation in the emergency room. The reason for consultation will not be taken into account, the only criterion being the age of the child. There will be no sign in the waiting room, the study will be proposed to them by the principal investigator.
~The questionnaires will be collected on live paper. The answers will be transferred in a second time on an Excel database protected by a password."
15921926|NCT03482791|Radiation|Proton beam therapy|"The daily prescription dose will be 1.8 or 2 Gy RBE (Relative Biologic Equivalence) to be delivered to the periphery of the planning target volume (PTV).
~The Mevion S-250 Proton Radiation Beam Therapy System will be used."
15921927|NCT03482791|Other|Patient-Reported Outcome Measures|-Prior to start of therapy, end of chemoradiation (day of end of treatment or up to 1 week after), 8 weeks, 4, 6, 9, and 12-months following end of chemoradiation
15921928|NCT03482765|Dietary Supplement|Probiotic 1|The product under investigation is a unique probiotic.
15921929|NCT03482765|Dietary Supplement|Probiotic 2|The product under investigation is a unique probiotic.
15921930|NCT03482765|Other|Placebo|Microcrystalline Cellulose
15921931|NCT03482752|Drug|Molgramostim|300 µg inhaled molgramostim in cycles of once daily administration for 7 days, then 7 days off treatment.
15921932|NCT03482726|Behavioral|Cycling Cadence Modulation|6-week high intensity training (HIIT) indoor cycling program, described later, at their prescribed cadence (FCC or EOC), using cadence meters.
15921933|NCT03482713|Drug|Gefapixant 45 mg|Gefapixant 45 mg (film-coated tablet) to be administered orally BID
15921934|NCT03482713|Drug|Placebo|Placebo (film-coated tablet) matching gefapixant to be administered orally BID
15921935|NCT03482700|Behavioral|Intervention Arm|The intervention group will have their usual annual COPD review performed by a specialist respiratory doctor at baseline and 12 months. The patients will receive care using our local COPD guidance which has been accepted by all local commissioning groups and secondary care organisations.
15921936|NCT03482700|Behavioral|Control Arm|Usual standard of care
15921937|NCT03482687|Behavioral|Me & You: Building Healthy Relationships|Me & You: Building Healthy Relationships is a classroom- and computer-based healthy relationships curriculum for middle school students. It consists of thirteen 25-minute lessons: 5 classroom, 5 computer-only, and 3 classroom-computer hybrid. The curriculum integrates group-based classroom activities (e.g., role-plays, group discussion, and other skill-building activities) and computer-based activities, some of which are individually tailored. The curriculum was adapted from an existing effective sex education and relationship curriculum, It's Your Game…Keep it Real (IYG), which was enhanced to more explicitly address teen dating violence (TDV).
15922168|NCT03480776|Other|Placebo|One tablet PO daily
15921938|NCT03482674|Behavioral|DIMINI lifestyle intervention|DIMINI lifestyle intervention consists of the DIMINI-kit which contains health information, a list of food recommendations with additional information on calories, serving size and weight (traffic light rating system), a nutrition and an exercise diary. Participants in the intervention group can choose between a paper-based version or an app-based version of the DIMINI-kit. In addition, the kit includes an elastic exercise band with exercise poster, a measuring tape for self-control of the waist size and a pedometer.
15921939|NCT03482661|Other|magnetic steering|The capsule was controlled to pass through the pylorus by magnet steering.
15921940|NCT03482648|Drug|BBT-401-1S, Single dose|Single dose of BBT-401-1S, 7 dose levels, oral capsule
15921941|NCT03482648|Drug|BBT-401-1S, Multiple doses|Multiple doses of BBT-401-1S, 7 days, 3 dose levels, oral capsule
15921942|NCT03482648|Drug|Placebo|Placebo matched to BBT-401-1S, oral capsule
15921943|NCT03482635|Drug|Spesolimab|Solution for infusion
15921944|NCT03482635|Drug|Placebo|Solution for infusion
15921945|NCT03482622|Diagnostic Test|Fast Raman|Fast Raman uses Raman spectroscopy to measure chemical profiles of tissue and provide a diagnostic map identifying BCC within 30 minutes.
15921946|NCT03482596|Behavioral|Reducing/breaking prolonged sitting|"The participants will be encouraged to reduce prolonged sitting by at least 60 minutes per day by introducing light upright movement breaks spread throughout their day. The frequency and duration of these breaks will be tailored to each participant to suit their individual circumstances.
~The intervention will involve education regarding the health implications of prolonged sitting, personalised goal setting, behavioural feedback and self-monitoring of behaviour."
15921947|NCT03482583|Drug|Nicotine Replacement Therapy|Participants in CBT group will also be offered Nicotine Replacement Therapy if they are interested. NRT is the same regimen followed in AHEC and Quitline. In addition, weekly counseling will be provided to the participants remotely via vidyo, a video based platform.
15921948|NCT03482583|Other|Referral to AHEC/Quitline|Participants will be referred to local AHEC/Quitline for treatment
15921949|NCT03482570|Device|ActiGraph|Activity behaviours will be objectively assessed by 7-day triaxial accelerometer assessment (ActiGraph GT3X+ Pensacola, FL, USA). Participants will be asked to wear an accelerometer around their waist, 24 hours a day for 7 days.
15921952|NCT03482544|Drug|Pragabalin|pregabalin 150 mg will be given orally, 1 day and 1 hour before surgery (totally two times), patients in Pregabalin Group.
15921953|NCT03482544|Other|Placebo|empty capsule will be given orally, 1 day and 1 hour before surgery (totally two times), patients in Control Group.
15921954|NCT03482531|Other|mathematical model|mathematical model: regression equation that calculates the mean time from insert placement to delivery for each patient, based on every patient's characteristics (parity, BMI, cervical dilation and state of membranes)
15921955|NCT03482518|Other|custom slippers with perforated synthetic leather cover.|the intervention group volunteers will receive a pair of custom slippers with perforated synthetic leather cover.
15921956|NCT03482505|Device|INVSENSOR00004|The INVSENSOR00004 will be placed on the subject's neck or chest to provide acoustic respiration rate.
15921957|NCT03482492|Drug|Tramadol|Tramadol iv
15921958|NCT03482492|Drug|Paracetamol|Paracetamol iv
15921959|NCT03482479|Drug|Naltrexone Hydrochloride|Naltrexone Hydrochloride will be taken daily (dose 4.5 mg) for six weeks
15921960|NCT03482479|Other|Placebo Comparator|A placebo tablet which matches the drug will be taken daily for 6 weeks.
15921961|NCT03482466|Behavioral|Neurofeedback|Patients will be inside an MRI machine. They will be trained using real time feedback from brain imaging to learn personal strategies to bring their brain to the CALM state.
15921962|NCT03482453|Drug|TAK-788|TAK-788 capsules.
15921963|NCT03482453|Drug|Placebo|TAK-788 placebo-matching capsules.
15921964|NCT03482453|Drug|TAK-788|TAK-788 DiC.
15921965|NCT03482440|Drug|Salsalate Oral Tablet|1500mg twice daily for 5 days prior to experimental testing
15921966|NCT03482440|Drug|Placebo Oral Tablet|Placebo oral table twice daily for 5 days prior to experimental testing
15921967|NCT03482427|Behavioral|Healthy Heart Score|Educational materials based on each component of the Healthy Heart Score and other lifestyle behaviors will be provided to the participants that include the following topics: Fruit and vegetable consumption, Whole grain consumption/ limiting refined grains, Healthy protein choices, Healthy dietary fats, Limiting Sugar-sweetened beverages, Importance of physical activity, Proper hydration, Stress management, Adequate Sleep, Smoking Cessation, Weekly menu example, Recipe Cards following the Mediterranean diet principals, Interactive weekly checklist to encourage participants to meet their weekly goals for consumption of fruits, vegetable, nuts and seeds. Participants will receive a check-in email or phone 6 weeks after the baseline visit. A Registered Dietitian is also available to speak with patients.
15921968|NCT03482414|Other|traditional wooden checkerboard|upper limb training with traditional wooden checkerboard
15921969|NCT03482414|Other|gaming board with single-player games|upper limb training with a LED-based interactive gaming board equipped with single-player games
15921970|NCT03482414|Other|gaming board with two-player games|upper limb training with two LED-based interactive gaming boards equipped with two-player competitive games
15921971|NCT03482401|Dietary Supplement|Polyphenol|Patients consume 3 capsules/day (474 mg phenolics/day) from the biopsy-confirmed breast cancer diagnosis to the surgery
15921972|NCT03482388|Behavioral|Crowdsourced materials|Among participants randomized to the intervention arm, intervention images and videos promoting HBV and HCV testing will be delivered through the WeChat platform. Men will also be invited to submit suggestions for how to improve intervention videos and images.
15921973|NCT03482388|Other|Control|Participants will not view any images or videos promoting HBV and HCV testing.
15921974|NCT03482362|Drug|Vinorelbine Tartrate|Intravenous administration of vinorelbine on day 1 and day 8 in a dose of 30 mg/m2. One treatment cycle is 21 days.
15922039|NCT03481907|Device|Nuvagen Collagen Powder|Daily application of Nuvagen collagen powder for 2 to 4 weeks following wounding
15922276|NCT03479879|Drug|Placebo Oral Tablet|Placebo
15921975|NCT03482349|Procedure|Total Knee Robotically-Assisted|The surgeon digitizes the shape of the joint and the computer transfers the planned surgical strategy to a dedicated surgical robot. Resections are performed by the surgeon on a constrained guide held by the robot.
15921976|NCT03482336|Other|Four FOP label designs|"Color (present and absent) were crossed with facial icon (present and absent) for a total of four FOP label treatments. For each trial, both packages had the same FOP treatment, but one appeared at a healthy level while the second unhealthy. Subjects were asked to choose the healthier option as quickly as possible. Accuracy and speed to correct selection both served as dependent variables."
15921977|NCT03482323|Behavioral|Exercise|Our exercise class intervention is based on current best evidence and will be tailored for each participant's ability for exercise. The exercise classes is also designed to fit into the guidelines for exercise in adults aged 18 years and above with a long term health condition. During the 12 weeks in the training, exercises will be varied (mixing up time spent on bikes and walking) along with the intensities of exercise varied to keep the classes more engaging for participants and maintaining compliance to the programme.
15921978|NCT03482323|Behavioral|Tai-Chi|Our tai-chi classes will be based on a 24-form Yang style of tai-chi exercise set.
15921979|NCT03482310|Device|Using the Neuroport cortical recording array to determine the desired grasp pattern for a functional electrical stimulation (FES) system|Participants will be asked to think about holding different shaped objects, and the recorded cortical signal patterns will be decoded to match those grasp shapes
15921980|NCT03482297|Device|automated abdominal binder|The binder automatically inflates every time the participant stands up to apply a compression level of about 40 mmHg. Participants will wear the device throughout the active/sham study day.
15921981|NCT03482297|Device|Sham binder|The binder automatically inflates every time the participant stands up to apply a compression level of about 5 mmHg. Participants will wear the device throughout the active/sham study day.
15921982|NCT03482297|Drug|Placebo|Oral placebo will be given three times a day on the baseline day (placebo)
15921983|NCT03482297|Drug|Midodrine|A midodrine pill 10mg will be given three times a day on the standard of care study day
15921984|NCT03482284|Other|Dietary Intervention|Participants receive different monosaccharides for a defined number of days.
15921985|NCT03482271|Other|No intervention - data collection only|No intervention - data collection only
15921986|NCT03482258|Dietary Supplement|Prebiotic|A daily dose for 3 weeks -14.5g per day in powder form dissolved in 200ml water. This equates to 10g GOS (VGOS is primarily 69% GOS, 23% Lactose).
15921987|NCT03482258|Dietary Supplement|Maltodextrin|A daily dose for 3 weeks -14.5g per day in powder form dissolved in 200ml water. This will be matched to VGOS for lactose (3.3g per dose of maltodextrin will be lactose).
15921988|NCT03482245|Other|Blue Light|"Subjects that are to be exposed to blue light will be provided by the research personnel with a Day-Light Classic 10,000 lumen SAD light, a device that has been used in many of the previously listed published studies (Epilepsy Behav. 2012 Jul;24(3):359-64. doi: 10.1016/j.yebeh.2012.04.123. Epub 2012 May 30.) The light is small (4 X 16 X 21 inches) and weights less than a pound. It is UV filtered and glare free. There is a single On/Off switch. It will be attached to a rolling stand.
~This light is fitted with a blue spectrum filter (peak 441 nm) such that it produces 1000 Lux of blue spectrum lighting when positioned at a distance of 12 inches from the subject."
15921989|NCT03482232|Drug|Benzodiazepines|Benzodiazepines for insomnia, agitation or delirium in people older than 65
15921990|NCT03482232|Drug|Non-steroidal anti-inflammatory drugs|Non-steroidal anti-inflammatory drugs in patients with cardiovascular disease, chronic kidney disease, hypertension, heart failure or liver cirrhosis
15921991|NCT03482232|Drug|paracetamol|paracetamol 1g for more than 3 days
15921992|NCT03482232|Drug|Antimicrobial agent|antibiotic in acute bronchitis when the patient does not suffer from COPD, heart failure, diabetes or kidney disease or is undergoing active chemotherapy
15921993|NCT03482232|Drug|Lipid-lowering drug|Lipid-lowering drugs in patients older than 75 years without previous cardiovascular events
15921994|NCT03482232|Diagnostic Test|Prostate cancer|Screening for prostate cancer in asymptomatic patients
15921995|NCT03482232|Radiation|Lumbago|image tests in non-specific lumbago
15921996|NCT03482232|Drug|Antimicrobial agent|antibiotics for pharyngitis (infants)
15921997|NCT03482232|Drug|Mucolytic|mucolytics, antitussives or antibiotics for upper respiratory infections (infants)
15921998|NCT03482232|Drug|Ibuprofen and paracetamol|treatment with ibuprofen and paracetamol (infants)
15921999|NCT03482219|Other|Occupational therapy|The Occupational therapy intervention includes various thermal modalities, manual therapy, Physiotouch (Healthy Life Devices Ltd) and education. The home app intervention involves one session of education with the occupational therapist.
15922000|NCT03482219|Other|Home app intervention|The app consists of videos depicting each exercise and ability to track adherence to exercises.
15922001|NCT03482206|Device|Automated extracranial internal carotid artery ultrasound sensor|The investigators' goal is to develop a wearable noninvasive, continuous, automated ultrasound sensor to accurately measure arterial blood flow volume outside of the head. Ultrasound uses sound waves to create a picture. In doing so, the investigators hope to detect CBF compromise early, preventing secondary injuries in TBI patients.
15922002|NCT03482180|Drug|KI1106 4g, QD|KI1106 4 Capsules
15922003|NCT03482180|Drug|Atorvastatin Calcium 20mg, QD|Atorvastatin Calcium 20mg
15922004|NCT03482167|Drug|Niagen®|250 mg capsules (4 capsules daily)
15922005|NCT03482167|Other|Placebo|placebo
15922006|NCT03482154|Procedure|Hematopoietic Stem Cell Transplant|Allogeneic and autologous stem cell transplants covering both malignant and non-malignant diagnoses.
15922040|NCT03481894|Drug|Kabiven®|"Infusion should start at a low dose (i.e., 12.5 to 25 mL/kg, corresponding to 10.6 to 21.2 kcal/kg/day, 0.49 to 0.98 g lipids/kg/day, 0.41 to 0.83 g amino acids/kg/day and 1.2 to 2.4 g dextrose/kg/day) followed by stepwise increase to the individual target for PN calories.
~The daily dose of the study PN should be infused at a constant rate over 20 to 24 hours.
~Route of Administration: Infusion into a central vein. Duration of Treatment: Study treatment will last for a minimum of 5 and a maximum of 8 consecutive days. Study treatment will be stopped if oral and/or enteral intake covers 80% or more of caloric requirements. If the indication for PN continues after 8 study days, PN will continue per normal institution policy."
15922277|NCT03479879|Drug|Misoprostol|Misoprostol
15922007|NCT03482141|Device|Whole Exome Sequencing (WES)|The Investigators will enroll pregnant women with fetal anomalies detected by ultrasound. Patients will be approached by a maternal-fetal specialist, who has counseled the patient regarding the fetal anomaly that has been detected. Written informed consent will be obtained by the study prenatal genetic counselor. Many patients will have undergone prenatal diagnostic testing in an outside laboratory; in such cases, cells or extracted DNA from the original fetal sample will be used for the purpose of this study. The consent process for prenatal WES will include pre-test counseling and the option of choosing whether or not to receive uncertain results and secondary findings. After conducting whole exome sequencing, the findings will be shared with the parent(s). Routine medical care will be provided to patients. The research will study the effectiveness of sequencing as a tool for providing genetic information to parents when a prenatal study reveals a fetus with a structural anomaly.
15922008|NCT03482128|Device|Coagulation management guided by SONOCLOT|Application of blood products guided by SONOCLOT measurements
15922009|NCT03482128|Device|Standard coagulation management|Application of blood products based on clinical experience of the anesthesiologist in charge
15922010|NCT03482115|Radiation|PET examination with radiopharmaceutical drug [18F] DPA-714|Using a Biograph 6 Truepoint device. Establishment of a venous route. It will be injected 4 MBq / kg of 18F-DPA714 by the venous route with a maximum dose of 280 MBq. The patient will be placed along the orbito-meatal line. Brain acquisition will begin 60 minutes post-injection
15922011|NCT03482115|Diagnostic Test|MRI examination|MRI device Philips Achieva - 3Tesla. The acquisition of the data will include different sequences (anatomical MRI, diffusion MRI, resting fMRI) and will last a total of one hour (installation and removal of the patient in the machine included).anatomical MRI associated with FLAIR (Fluid Attenuation Inversion Recovery) and diffusion tensor (tractography).
15922012|NCT03482115|Biological|Blood samples|Characterization of the TSPO phenotype (mitochondrial translocase) for tracer affinity
15922013|NCT03482102|Drug|Tremelimumab|Tremelimumab target the cancerous proteins and stop the cancer cells from suppressing the immune system
15922014|NCT03482102|Drug|Durvalumab|Durvalumab target the cancerous proteins and stop the cancer cells from suppressing the immune system
15922015|NCT03482102|Radiation|Radiation|Radiation therapy is used to shrink cancer cells.
15922016|NCT03482089|Procedure|Cystoprostatectomy|Patients with bladder infiltrating T4 prostate cancer receive cystoprostatectomy with urinary diversion surgery and extended pelvic lymph node dissection
15922017|NCT03482089|Radiation|external beam radiotherapy|Patients with bladder infiltrating T4 prostate cancer are treated with adjuvant androgen deprivation therapy
15922018|NCT03482076|Diagnostic Test|transferrin receptor concentration|Sandwich radio-imunoassay
15922019|NCT03482063|Dietary Supplement|Swisse Ultiboost Memory + Focus|"B vitamins help energy release, help with metabolism of food into energy, assist energy production and vitality.
~Vitamin B5 helps support normal mental performance. Brahmi, Ginkgo, Vitamin B12 and B3 help support brain function. Ginkgo helps maintain healthy circulation and delivery of oxygenated blood to the brain.
~Brahmi supports memory function and recall. Vitamin B5, B6 are important for adrenal function, assist adrenal glands during stress periods.
~Vitamin B2, B3, B5, B6, B12 help relieve tiredness and fatigue."
15922020|NCT03482063|Other|Placebo|riboflavin (2.2mg)
15922021|NCT03482050|Biological|AstroRx|Astrocytes derived from human embryonic stem cells
15922022|NCT03482037|Drug|Rec 0/0438 1 mg or Rec 0/0438 2 mg|Each vial content will be administered via the catheter used for the self-catheterization
15922023|NCT03482037|Drug|placebo|Each vial content will be administered via the catheter used for the self-catheterization
15922024|NCT03482024|Drug|Tirzepatide|Administered SC.
15922025|NCT03482011|Drug|Mirikizumab|Administered SC
15922026|NCT03482011|Drug|Placebo|Administered SC
15922027|NCT03481998|Drug|SHR6390|SHR6390 150 mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
15922028|NCT03481998|Drug|Letrozole or anastrozole or Fulvestrant|Letrozole 2.5mg or anastrozole 1mg, orally once daily (continuously)， or Fulvestrant 500mg intramuscular injection on day 1 and day 15 for the first cycle and then on day 1 for every cycle until progressive disease
15922029|NCT03481985|Other|Fenestration status|The exposure variable will be status of the Fontan fenestration
15922030|NCT03481972|Drug|Doxycycline and tauroursodeoxycholic acid|doxycicline and tauroursodeoxycholic acid
15922031|NCT03481972|Drug|Standard of care|Standard of care
15922032|NCT03481959|Drug|Methylphenidate|"Methylphenidate delay shape, 10 and 30 mg and matching Placebo capsules. Treatment should be started at a dose of 10 mg per day or 20 mg/d (depending on the weight of patients), with increasing weekly, according to the clinical tolerance, in order to get an effective dose on the symptoms of ADHD to S4, not more than 1 mg/kg/d (capped at 60 mg/d).
~This gradual dose treatment will be resumed in the same manner in M3 at the beginning of the phase in open, allowing the respect of the average of the ADHD support (no), without loss of chance for the Group at 3 months, because it is customary to discontinue treatment during holiday periods)."
15922033|NCT03481959|Other|Matching Placebo|"Methylphenidate delay shape, 10 and 30 mg and matching Placebo capsules. Treatment should be started at a dose of 10 mg per day or 20 mg/d (depending on the weight of patients), with increasing weekly, according to the clinical tolerance, in order to get an effective dose on the symptoms of ADHD to S4, not more than 1 mg/kg/d (capped at 60 mg/d).
~This gradual dose treatment will be resumed in the same manner in M3 at the beginning of the phase in open, allowing the respect of the average of the ADHD support (no), without loss of chance for the Group at 3 months, because it is customary to discontinue treatment during holiday periods)."
15922034|NCT03481946|Drug|BAY1093884|0.3 mg/kg given intravenously
15922035|NCT03481946|Drug|BAY1093884|1 mg/kg given intravenously
15922036|NCT03481933|Device|Transcranial stimulation|"10 days of stimulation (20min, 1.59mA) in double-blind sham-controlled. 3 arms (N=20 in each arm):
~left-excitatory tDCS (N=20)
~right-inhibitory tDCS (N=20)
~sham tDCS (N=20)
~4 language/semantic evaluations: base-line; 3 days; 2 weeks; 4 months post-tDCS
~2 MRI/PET acquisitions: pre-stimulation (base-line); 2 weeks post-tDCS"
15922037|NCT03481920|Drug|PEGylated Recombinant Human Hyaluronidase (PEGPH20)|PEGPH20 will be administered at a dose of 3.0 micrograms per kilogram (μg/kg) as an intravenous (IV) infusion.
15922038|NCT03481920|Drug|Avelumab|Avelumab will be administered as at a dose of 10 milligrams per kilogram (mg/kg) as an intravenous (IV) infusion once every 2 weeks.
15922041|NCT03481894|Drug|Compounded standard parenteral nutrition|"Infusion should start at a low dose (i.e., 12.5 to 25 mL/kg, corresponding to 10.6 to 21.2 kcal/kg/day, 0.49 to 0.98 g lipids/kg/day, 0.41 to 0.83 g amino acids/kg/day and 1.2 to 2.4 g dextrose/kg/day) followed by stepwise increase to the individual target for PN calories.
~The daily dose of the study PN should be infused at a constant rate over 20 to 24 hours.
~Route of Administration: Infusion into a central vein. Duration of Treatment: Study treatment will last for a minimum of 5 and a maximum of 8 consecutive days. Study treatment will be stopped if oral and/or enteral intake covers 80% or more of caloric requirements. If the indication for PN continues after 8 study days, PN will continue per normal institution policy."
15922042|NCT03481881|Drug|Standard of care drug|This study is collecting PK data on children prescribed the following drugs of interest per standard of care: dexmedetomidine, bosentan, furosemide, chlorothiazide, ethacrynic acid, bumetanide, hydromorphone, tacrolimus, ampicillin, gentamicin, caffeine, fentanyl, midazolam, foscarnet, hydroxychloroquine, and moxifloxacin.
15922043|NCT03481868|Biological|Collection of blood and bone marrow|Collection of blood and bone marrow in order to identify epigenetic abnormalities and their consequences in surviving CML cells after 3 months of TKI treatment
15922044|NCT03481855|Device|Lower-body-low-pressure chamber|The lower-body-low-pressure chamber administers a negative pressure to the lower part of the body (below the waist) to induce a central hypovolaemia by pooling of blood in the legs according to Tymko, M. FACETS, Bd. 1, Nr. 1, S. 225-244, März 2017 and Esch, B.T.A. et al. AJP Adv. Physiol. Educ., Bd. 31, Nr. 1, S. 76-81, März 2007.
15922048|NCT03481816|Biological|ETBX-071; adenoviral PSA vaccine|5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
15922049|NCT03481816|Biological|ETBX-061; adenoviral MUC1 vaccine|5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
15922050|NCT03481816|Biological|ETBX-051; adenoviral brachyury vaccine|5 x 10 to the eleventh power VP (standard dose), 1 x 10 to the eleventh power VP (DL-1), or 5 x 10 to the tenth power VP (DL-2) subcutaneous injection every 3 weeks for 3 immunizations.
15922051|NCT03481803|Drug|MS1819-SD|Patient will receive increasing doses from the lowest dose of MS1819-SD to a maximum dose of MS1819- SD. The total treatment phase will range from 48 days to 60 days.
15922052|NCT03481790|Drug|Lactoferrin|(Pravotin sachets, Hygint, Egypt): 100 mg in 1/4 glass of water before meals twice a day for 4 weeks.
15922053|NCT03481790|Drug|ferrous sulphate + folic acid (vitamin B9)|(Ferrofol capsules, Eipico, Egypt): Dried ferrous sulphate 150 mg + Folic acid (Vitamin B9) 150 mg at least 1 hour before or 2 hours after meals three times a day for 4 weeks.
15922054|NCT03481777|Device|Remote Ischemic Conditioning|RIC is commonly achieved by inflation of a blood pressure cuff to induce 5-minute cycles of limb ischemia alternating with 5 minutes of reperfusion.
15922055|NCT03481777|Device|Sham Remote Ischemic Conditioning|Sham Comparator (Sham-RIC)
15922056|NCT03481764|Genetic|HRC-test|"Using HRC-test we analyze 20 selected genetically controlled morphophysiological traits among FS children and control.Homozygous-recessive traits in the region of human head are: attached ear lobe,continuous frontal hair line,blue eyes straight hair,soft hair and blond hair,double hair whorl,hair whorl orientation-opposite from clock-wise,as well as an inability to roll,fold and curve the tongue,a guttural r and Daltonism.HRC trait expressed in human arms and legs, such as distal or proximal hyper-extensibility of the thumb,index finger shorter than the ring finger,left-handedness, hand clasping pattern.In order to achieve high level of objectivity during the process of data gathering, the same person conducting all testing.Inside the group of charcteristics which show high level of variability,only the extreme phenotypes were considered recessive.For the purpose of testing the color blindness in examinees,the Pseudoisochromatic plates test was used."
15922057|NCT03481751|Diagnostic Test|Diagnostic test: Ultrasound|Transabdominal ultrasound of the bowel for categorization of disease activity
15922058|NCT03481725|Device|ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator (SPR Therapeutics, Cleveland, Ohio)|ACTIVE peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that generates electric current for 14 days
15922059|NCT03481725|Device|SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable SHAM stimulator (SPR Therapeutics, Cleveland, Ohio)|SHAM peripheral nerve stimulation with a percutaneously inserted lead and wearable stimulator (SPR Therapeutics, Cleveland, Ohio) that does not generate electric current for 14 days
15922060|NCT03481712|Diagnostic Test|Diagnostic tests|"Head-to-head comparison between:
~CADScor and Diamond-Foster score
~Rb PET and 3T CMRI
~QFR and ICA-FFR"
15922061|NCT03481699|Behavioral|Incremental theory of personality|"The experimental intervention (originally developed by David S. Yeager and colleagues) teaches that individuals have the potential to change. It has three main parts. First, participants are asked to read scientific studies that provide evidence that behaviors are controlled by thoughts and feelings in brains, and that pathways in the brain have the potential to be changed under the right circumstances. Second, participants read several testimonials purportedly written by upperclassmen to bring credibility to the ITP. Finally, participants are asked to write their own version of such a narrative. This self-persuasive writing exercise has been shown to facilitate the internalization of the intervention message, building on a long line of research on cognitive dissonance."
15922062|NCT03481699|Other|Educational Intervention|The educational intervention involved scientific information about the human brain. It was designed to be parallel to the experimental intervention and, hence, it has also three main parts. First, participants are asked to read scientific information about the different areas of the brain and their specialties. Second, participants read several testimonials written by upperclassmen about their transition to high school and how their brains help them to adapt to the new space and all the physical differences of the building and the classes. Finally, participants are asked to write a letter to another student explaining the main things he or she has learned about the brain and thinks are important for adapting to the new physical environment in high school.
15922166|NCT03480789|Device|eye patch|wearing the eye patch from 22:00 to 6:00 of the next day
15922063|NCT03481686|Device|Patients with injections of ESA|Patients will perform ASE injections themselves or by their spouses
15922064|NCT03481673|Behavioral|COPE for Asthma|The intervention will consist of 7 weekly sessions (30 minutes each). COPE for Asthma is a manualized, cognitive behavior skills-building intervention to improve the physical and mental health outcomes of children with asthma and elevated symptoms of anxiety or depression.
15922065|NCT03481660|Drug|Brolucizumab|Intravitreal injection
15922066|NCT03481660|Drug|Aflibercept|Intravitreal injection
15922067|NCT03481647|Procedure|Oral care programme|Professional oral care (dental hygienist), intensified oral care measures by the patient
15922070|NCT03481621|Device|Acupuncture|Needle size: #32(0.22 mm), 1-1.5 inch(30-40 mm long); Acupuncture time and frequency: 45 min per session, once or twice per week, for 6-12 sessions total (in 6 weeks).
15922071|NCT03481621|Other|Standard care|PT, pain medications, nerve block, etc
15922072|NCT03481608|Other|Lauric acid (coconut oil)|A breakfast shake made from a complete meal shake will be prepared with water and supplemented with 2 tablespoons of coconut oil.
15922073|NCT03481608|Other|No Lauric acid (olive oil)|A breakfast shake made from a complete meal shake will be prepared with water and supplemented with 2 tablespoons of olive oil.
15922074|NCT03481595|Device|HealthLoop mobile application|Patients will utilize the HealthLoop mobile application on their mobile device during the post-operative period in addition to standard, routine medical care.
15922075|NCT03481582|Drug|Nitroglycerin|(nitrodermal®) 5 mg (patch)as a source of Nitric oxide from 2nd day of cycle till maturation of the follicles ≥ 18 mm just for one cycle.
15922076|NCT03481582|Device|Three dimensional power doppler|Once the follicle reached ≥18 mm 3D power Doppler will be used to assess the uterine and subendometrial blood flow
15922077|NCT03481569|Other|Blood and cerebrospinal fluid pharmacocinetic samples on one of the nine antibiotics prescribed in routine use|Blood and cerebrospinal fluid pharmacocinetic samples at different time point
15922078|NCT03481556|Drug|Melphalan flufenamide (Melflufen)|Intravenous infusion
15922079|NCT03481556|Drug|Dexamethasone|Oral tablets
15922080|NCT03481556|Drug|Bortezomib|Subcutaneous administration
15922081|NCT03481556|Drug|Daratumumab|Intravenous infusion
15922082|NCT03481543|Procedure|In-line nebulization through NIV mask|In-line nebulization will be given through NIV circuit.
15922083|NCT03481543|Procedure|Off-NIV nebulization|Bronchodilator nebulization is given during which NIV mask is taken off for a short time and reapplied when nebulization is finished..
15922084|NCT03481530|Device|Continuing Glucose Monitor System|glucose monitoring
15922085|NCT03481517|Drug|Bupivacaine|Bupivacaine 5 mL subcutaneous injection to surgical wound during operation.
15922086|NCT03481504|Behavioral|Acceptance & Commitment Therapy-Exposure and Perspective Taking|To increase patients' participation by improving their level of coping with chronic pain.
15922087|NCT03481491|Other|transcranial magnetic stimulation of the cerebellum|The intervention will consist in a continuous theta burst stimulation of the cerebellum under neuronavigation.
15922088|NCT03481478|Diagnostic Test|CT and MRI|For such patients, using CT and/or MRI to find if existing humeral surgical neck fractures.
15922089|NCT03481452|Behavioral|psychotherapy|NBO is an infant-focused, family relationship-based intervention measure, which aims to exhibit to parents infants' surprised ability, understand infants' strength and aspects needed to be improved, strength parents' parenting confidence, and promote sound development of infant-mother relationship.
15922090|NCT03481439|Other|Collection of a Pharmaceutical intervention|collection of pharmaceutical interventions carried out by the pharmaceutical team in the care uni in Primary and secondary cohort
15922091|NCT03481426|Other|Workplace intervention|The study contains normal services of occupational health. Both intervention groups are based on voluntary will, and the normal care and services are guaranteed. In the intervention group new working method which improve co-operation between occupational health services and workplaces.
15922092|NCT03481413|Device|Ablation|Ablation therapy for cardiac arrhythmias
15922093|NCT03481400|Drug|Calcitonin Gene-Related Peptide|Calcitonin gene-related peptide intravenous infusion (1.5 micrograms/min for 20 mins)
15922094|NCT03481400|Other|Placebo|Isotonic saline
15922095|NCT03481387|Device|prosthetic aortic valve (PERCEVAL S valve)|The PERCEVAL S heart valve (PERCEVAL S valve) is a bioprosthesis manufactured with bovine pericardium and assembled on a Nitinol stent. The PERCEVAL S valve is designed to offer an alternative to surgically implanted flexible prostheses (stented and stentless biological valves). A special feature of the device is that it is self-anchoring and does not require sutures to be fixed to the implant site.
15922096|NCT03481374|Diagnostic Test|autonomic function testing|"autonomic function testing, ergospirometry, three questionnaires
~Other Names:
~The autonomic function tests consist of five tests:
~The Valsalva maneuver
~The isometric handgrip test
~The deep breathing test
~The cold pressor test
~A short head-up tilt test
~A maximal ergospirometry
~Three questionnaires:
~EQ-5D-3L: quality of life
~IPAQ: capacity to do physical activities"
15922097|NCT03481348|Device|Pharyngeal Electrical Stimulation|Pharyngeal Electrical Stimulation is applied at the pharynx via a nasogastral tube for 10 minutes per day on 3 consecutive days.
15922098|NCT03481335|Other|CHAP-P Sessions|Residents of intervention communities (barangays) aged 40+ are openly invited to attend CHAP-P sessions. At CHAP-P sessions, trained local volunteers (Barangay Health Workers, or BHWs) collect consent, measure blood pressure, collect other physical measurements, and conduct a survey to determine clients' risk of diabetes. Based on the findings, BHWs provide education and/or referrals. CHAP-P sessions are held twice a month, and clients are encouraged to continuing attending for ongoing follow-up and monitoring.
15922099|NCT03481322|Dietary Supplement|Cooked diet with controlled amount of salt|Cooked diet with controlled amount of salt by nutritionist - 2 grams of salt per patient
15922100|NCT03481309|Device|anodal tDCS|The participant will receive anodal tDCS with 2 mA for 10 minutes on the left motor cortex.
15922101|NCT03481309|Device|cathodal tDCS|The participant will receive cathodal tDCS with -2 mA for 10 minutes on the left motor cortex.
15922102|NCT03481309|Device|sham tDCS|The participant will receive sham tDCS with 2 mA for 40 seconds on the left motor cortex which mimics the skin sensations as active tDCS interventions.
15922103|NCT03481296|Behavioral|Advanced Control|Participants receive linguistically and culturally tailored information booklet on colorectal cancer and colorectal cancer screening, colonoscopy instructions, stool blood test kits and reminder by mail. Participants' height, weight, and waist/hip circumference, blood pressure, blood glucose, and cholesterol levels will be measured by trained research staff. Participants will also receive the result of body measurements right away as a free service.
15922104|NCT03481296|Behavioral|Culturally-Adapted Decision Support Navigation Intervention|Participants in this group receive everything that advanced control group receives. In addition to a set of standard materials, they receive culturally and linguistically adapted decision counseling from the patient navigator. The patient navigator develops an individualized colorectal cancer screening plan using a theory-based online Decision Counseling Program. After the Program is completed, the patient navigator develops individualized colorectal cancer screening plan and shares the information with participants and participants' primary care physicians. Then, primary care physicians encourage the colorectal cancer screening to participants.
15922105|NCT03481270|Behavioral|Concordant|We will be randomizing across providers - we are particularly interested in racial concordance.
15922106|NCT03481218|Other|The World Health Organization Quality of Life (WHOQOL) -BREF|The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment.
15922107|NCT03481218|Other|The Satisfaction With Life Scale - SWLS|The SWLS is a short 5-item instrument designed to measure global cognitive judgments of satisfaction with one's life.
15922108|NCT03481218|Other|Big Five Inventory - BFI; John in Srivastava, 1999|The Big Five Inventory (BFI) is a self-report inventory designed to measure the Big Five dimensions.
15922109|NCT03481205|Device|Ischemic conditioning device|RLIC will be done using a specialized blood pressure device ( Doctormate) that inflates to 200 mm HG for 5 minutes followed by 5 minutes deflation.
15922110|NCT03481192|Behavioral|Two visits for evaluation|"Visit 1:The first evaluation (E1) of cognitive functions will take place directly following the psychiatric interview (T1), in order to better reflect the cognitive abilities at the time of the proposal of the care project.
~This will include the Memory Functioning Questionnaire (MFQ), the five words of DUBOIS, the TMT-A and B, the WAIS code test, and the BADDELEY door test. An intercurrent type ringing event of the phone will take place during this evaluation.
~Visit 2: At 24h-48h of the psychiatric evaluation (T2), a second evaluation (E2) will take place.
~An episodic memory score will be determined by asking the patient to recall,as precisely as possible the evaluation E1. At first the reminder will be free,the data can be completed, if necessary, with an indication, a recognition."
15922111|NCT03481179|Device|TMS|Repetitive TMS involves application of electric currents in the patient's cortex by a magnetic field applied to the scalp of the patient through an eight-coil connected to a magnetic stimulator (MagStim Rapid² magnetic stimulator-UK). In a small percentage of patients, it may cause some discomfort with a mild headache sensation or nausea. Depending on the parameters, rTMS can increase or decrease corticomotor excitability and by the connection of the motor cortex with the thalamus, influencing spasticity inhibition. The patients will respond to an adverse effects questionnaire and will report the perception of real or sham stimulation.
15922112|NCT03481179|Other|Physical therapy|The physical therapy, with an duration of 40-50 minutes, will be focused on the upper limbs and will be based on the principles of neuroplasticity (repetition, intensity, specificity, among others (KLEIM & JONES, 2008), with a protocol that will cover different exercises and degrees of difficulty, which will be chosen according to the need and capacity of each patient
15922113|NCT03481166|Other|Education on breastfeeding pain|A Registered Nurse with specialization in antenatal and postpartum care will deliver a one-hour, group-based educational session specifically on breastfeeding-related pain, including: common causes of nipple pain, prevalence of nipple pain, impact of pain on milk ejection reflex, and common approaches to prevention and management of nipple pain.
15922114|NCT03481153|Device|Transcranial direct current stimulation (tDCS)|tDCS is a safe, non-invasive neurostimulation technique that can modulate neural excitability in the brain to positively impact cognition, behaviour and mood, particularly when combined with a behavioural intervention
15922115|NCT03481140|Device|TissuGlu Surgical Adhesive|lysine-derived urethane adhesive
15922116|NCT03481127|Behavioral|Integrated psychological care|Additional possible strategies used may include supportive or validating interventions, increasing/introducing/reinforcing coping strategies, psychoeducation; distress tolerance skills; brief cognitive behavioral therapy; cognitive restructuring; activity scheduling; acceptance; and relaxation/mindfulness.
15922117|NCT03481127|Other|Surveys|"NCCN Distress Thermometer
~PROMIS Depression & Anxiety
~Quality of Life (SF-12)
~Brief COPE
~Patient awareness and satisfaction survey"
15922118|NCT03481127|Procedure|Blood draw|"For patients with ovarian, fallopian tube, or primary peritoneal cysts
~Optional
~Enrollment, 3 months after enrollment, and 6 months after enrollment"
15922119|NCT03481127|Procedure|Fresh tissue from ovary|"For patients with ovarian, fallopian tube, or primary peritoneal cysts
~Optional
~At time of standard of care surgery"
15922120|NCT03481114|Combination Product|PET-based, dose-painted, accelerated chemoradiotherapy|Patients in this arm will receive a more personalized and shorter radiation therapy treatment course utilizing PET imaging.
15922121|NCT03481114|Combination Product|Standard chemoradiotherapy|Patients in this arm will receive a standard radiotherapy course.
15922122|NCT03481101|Device|PET/CT|3 extra scans with FDG-PET/CT and 4 blood samples
15922123|NCT03481088|Procedure|Functional appliance therapy|"All records, including MRI scans will be collected at three stages and will be traced for various angular and linear measurements to document the alterations within the condyle glenoid fossa complex.
~Stage- I (pre-treatment),
~Stage- II (after pre-functional therapy)
~Stage-III (After 6-8 months of functional appliance therapy that is after correction to Class I molar relation)"
15922124|NCT03481075|Other|Biomechanical computer program|Fusion assisting software for image-guided intervention
15922125|NCT03481049|Behavioral|Usual CM|Behavioral reinforcement for alcohol abstinence
15922126|NCT03481049|Behavioral|High-Magnitude CM|Behavioral reinforcement for alcohol abstinence
15922127|NCT03481049|Behavioral|Shaping CM|Behavioral reinforcement for alcohol abstinence
15922128|NCT03481036|Drug|Direct Acting Antivirals|Sofosbuvir and Daclatasvir
15922129|NCT03481036|Drug|DAAs in Cirrhotics Genotype 2/3|Sofosbuvir and Daclatasvir with weight based ribavirin
15922130|NCT03481036|Drug|DAAs in Cirrhotics Genotye 1,4,5,6|Sofosbuvir and Ledipasvir with weight based ribavirin
15922131|NCT03481023|Device|EnsoETM|Use of esophageal thermal regulation device during radiofrequency ablation.
15922132|NCT03481023|Procedure|Conventional Care|Use of luminal esophageal temperature monitoring during radiofrequency ablation procedure.
15922133|NCT03481010|Procedure|PAO with hip arthroscopy|Participants who are randomized to the Scope-PAO group will receive central compartment hip arthroscopy in addition to the PAO.
15922134|NCT03481010|Procedure|PAO without hip arthroscopy|"Participants who are randomized to the PAO-only group will receive a Bernese Periacetabular Osteotomy (PAO) for treatment of hip dysplasia."
15922135|NCT03480997|Combination Product|Albuterol Sulfate and Ipratropium Bromide|
15922136|NCT03480997|Combination Product|Albuterol Sulfate|
15922137|NCT03480984|Other|Programmed Intermittent Bolus|6 mL 0.2% ropivacaine hourly, starting on arrival to PACU, given via an hourly programmed bolus
15922138|NCT03480984|Other|Continuous Infusion|6 mL 0.2% ropivacaine hourly, starting on arrival to PACU, given via continuous infusion
15922139|NCT03480971|Drug|Tempol|Investigational product is Tempol (4-hydroxy-2,2,6,6-tetramethylpiperidine-1-oxyl) oral solution. Tempol solution is an orange-colored, aqueous solution containing 7% Tempol along with xanthan gum, xylitol, aspartame, acesulfame potassium, sodium saccharin, alcohol, peppermint and wintergreen oils.
15922140|NCT03480971|Drug|Placebo Solution|The placebo contains the same excipients as the active product plus FD&C Yellow #6 for color matching.
15922141|NCT03480958|Device|Intravenous morphine patient controlled device|24 hour morphine consumption will be recorded
15922142|NCT03480958|Other|Erector Spinae Plane Block|erector spinae plane block will be administered before the surgery
15922143|NCT03480958|Other|Thoracic Paravertebral Block|thoracic paravertebral block will be administered before the surgery
15922144|NCT03480945|Diagnostic Test|serotonin|Endothelium-dependent dilatation
15922145|NCT03480932|Drug|Sofosbuvir|Direct acting antiviral agent used for the treatment of hepatitis C
15922146|NCT03480932|Drug|Daclatasvir|Direct acting antiviral agent used for the treatment of hepatitis C
15922147|NCT03480932|Drug|Pegylated Interferon alfa-2a|Antiviral agent used for the treatment of hepatitis C
15922148|NCT03480919|Device|Shen Men acupuncture|20-minute acupuncture session
15922149|NCT03480919|Procedure|Epidural injection|Epidural injection for the relief of back pain
15922150|NCT03480906|Drug|Latanoprost|Latanoprost ophthalmic solution administered as a microdose spray
15922151|NCT03480906|Drug|Latanoprost|Latanoprost ophthalmic solution administered as an eyedrop
15922152|NCT03480893|Procedure|small size interarcuair decompression|A median lumbar incision is made and the paravertebral muscles are dissected subperiosteally and retracted unilaterally or bilaterally. Decompression will be applied via decompression of the ligamentum flavum. The lateral recess will be opened bilaterally and a medial facetectomy will be performed in order maintain stability of the segments. Posterior ligaments will be spared. The wound will be closed in layers with or without a suction drain. Patients will be operated with a loupe magnification or microscope depending on the surgeon's preference.
15922153|NCT03480893|Procedure|Laminectomy|A median lumbar incision is made over the spinous processes, the laminae of the affected level(s) are exposed subperiosteally, and the supraspinous ligament will be incised. The spinous process is removed. The supra and interspinous ligament of the affected level is removed by drill or Kerrison punches. The lamen is removed of the affect level, leaving the facet joint intact. The lateral recess will be opened bilaterally and medial facetectomy will be performed in order to maintain stability of the segments. When a single level stenosis is present (e.g. L4-L5) both laminae L4 and L5 will be removed. The wound will be closed in layers with or without a suction drain. Patients will be operated with loupe magnification or microscope depending surgeon's preference.
15922154|NCT03480880|Device|Bispectral Index|Thiopentone was administered in 50 mg boluses during induction of anaesthesia, until reduction of Bispectral Index value to less than 50, and total dose of thiopentone recorded.
15922155|NCT03480867|Drug|Temozolomide|Experimental: Registered one arm study Seven days of pre-operative Radiation+Temozolomide followed by surgery plus TMZ, as adjuvant component.for six cycles.
15922156|NCT03480867|Radiation|Pre-Operative Radiation|Radiation is given with Temozolomide for 7 days before surgery
15922157|NCT03480854|Other|Quality Improvement|Randomly selected sites will receive one of two system level improvement approaches; 1) patient centered specialty medical home certification 2) IHI Breakthrough Series improvement approach with professional improvement coaching.
15922158|NCT03480841|Behavioral|Language ENhancement Assessment/intervention system|The LENA with Feedback intervention will involve mothers running the Language ENhancement Assessment/intervention system, an audiorecorder language pedometer that records adult speech centered on the child, child vocalizations, and parent-child reciprocal turn-taking conversations. Researchers will provide an initial feedback session to mothers, which will include reviewing the LENA visual output from the previous recording and how mothers can access the output on their own for future recordings. Mothers will independently use the LENA system and access the output on their own.
15922159|NCT03480828|Diagnostic Test|comparaison between DE and DTF in prediction of extubation success|diaphragm ultrasound and measurement of DE and DTF in patients meeting all extubation criteria during spontaneous breathing trial
15922160|NCT03480815|Device|Nocturnal Temperature Controlled Laminar Flow Device|Record of the time to first asthma exacerbation, lung function and exhaled NO level
15922161|NCT03480815|Other|None Device|Record of the time to first asthma exacerbation, lung function and exhaled NO level
15922162|NCT03480802|Biological|V114|15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose
15922163|NCT03480802|Biological|Prevnar 13™|13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose
15922164|NCT03480802|Biological|PNEUMOVAX™23|23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose
15922165|NCT03480789|Drug|Dexmedetomidine|given dexmedetomidine to meet RASS -1 from 22:00 to 6:00 of the next day
15949894|NCT03265132|Biological|anakinra|sub cutaneous injection
15922169|NCT03480763|Biological|V114|15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose
15922170|NCT03480763|Biological|Prevnar 13™|13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose
15922171|NCT03480763|Biological|PNEUMOVAX™23|23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose
15922172|NCT03480750|Drug|trientine dihydrochloride|trientine dihydrochloride 300MG/CAPSUE PO daily (in different dose levels)
15922173|NCT03480750|Drug|pegylated liposomal doxorubicin|pegylated liposomal doxorubicin 40mg/m2 IV D1
15922174|NCT03480750|Drug|carboplatin|carboplatin AUC 4 IV D1
15922175|NCT03480737|Device|Magstim Super Rapid2 stimulator, 10 Hz condition|10 Hz (2,000 pulses) at left DLPFC
15922176|NCT03480737|Device|Magstim Super Rapid2 stimulator, Sham condition|sham
15922177|NCT03480737|Device|Magstim Super Rapid2 stimulator, iTBS condition|50 Hz, iTBS (600 pulses) at left DLPFC
15922178|NCT03480724|Other|Google Cardboard VRA|Intervention was randomized and shuffled.
15922179|NCT03480724|Other|Oculus Rift VRA|Intervention was randomized and shuffled.
15922180|NCT03480711|Procedure|SST in group (A)|group (A) single surgeon, using retrobulbar anaesthesia with 2% lidocaine, will be performed in all surgeries. Following insertion of a lid speculum, a 10/0 silk bridle suture is inserted at superior limbus if required. In group (A) a conjunctival incision is made at the limbus to create a fornix-based conjunctival flap. A half thickness scleral flap (4 × 4 mm) are created and dissected into the clear cornea. A cellulose microsponge soaked in 0.3 mg/ml MMC solution (Mitomycin-C) is applied to the under surface of the scleral flap over a wide posterior area for 2 ml
15922181|NCT03480711|Procedure|trabeculectomy with ESST in group (B)|group (B), another longitudinal scleral groove will be created in the center of the deep scleral bed area measured about 1.5 × 6 mm.In both groups, standard trabeculectomy of equal size (two bites aside) is created by a Kelly punch ( 1 mm)
15922182|NCT03480698|Drug|Cerebrolysin|Dosage, frequency, duration and mode of administration of Cerebrolysin follow the local hospital practice in accordance with the terms of the local marketing authorization and is not amended or influenced by the study. Prescribed Cerebrolysin will be used as solution for injection/concentrate for solution for infusion.
15922183|NCT03480685|Device|IVUS and OCT Imaging|Use of an imaging catheter
15922184|NCT03480672|Drug|Pembrolizumab 25 MG/1 ML Intravenous Solution [KEYTRUDA]|intravenous application, 12 months, in 3-week cycle (q3w) 200 mg
15922185|NCT03480672|Other|adjuvant radiochemotherapy|adjuvant radiochemotherapy with cisplatin
15922186|NCT03480646|Drug|CPI-1205|Administered orally
15922187|NCT03480646|Drug|Enzalutamide|Administered orally
15922188|NCT03480646|Drug|Abiraterone/Prednisone|Administered orally
15922189|NCT03480620|Other|Online Telerehabilitation Platform Access|Participants will have 24/7 access to a standardized set post-discharge exercise videos and self-management instructions across multiple internet connected devices (e.g. computer, tablet, smartphone). Standardized exercises include a flexibility routine that participants learned and performed with a physical therapist while in the pain management program. Self-management instructions are also written versions of concepts learned and practiced with a member of the multidisciplinary team during the pain management program.
15922190|NCT03480620|Other|Usual care|Participants are given a DVD of the standardized post-discharge exercise videos and a written copy of the self-management instructions as described in the experimental group.
15922191|NCT03480607|Drug|Dexmedetomidine group|0.75 ml of 0.5% Bupivacaine in conjunction with 0.5 mcg/kg dexmedetomidine
15922192|NCT03480607|Drug|Dexamethasone group|0.75 ml of 0.5% Bupivacaine in conjunction with 0.1 mcg/kg dexamethasone
15922193|NCT03480594|Drug|Hyperpolarized [13C] Pyruvate Injection|HP Pyruvate Injection two times during MRI with 45 minute rest period between in Fatty Liver Patients and Healthy Control Subjects
15922194|NCT03480581|Behavioral|Forward First ICARE Training|Participants will engage in 12-sessions in forward direction, followed by 12-sessions in the reverse direction. Sessions will be scheduled 3 times/week with training parameters adjusted to progressively increase challenge as tolerated.
15922195|NCT03480581|Behavioral|Reverse First ICARE Training|Participants will engage in 12-sessions in reverse direction, followed by 12-sessions in the forward direction. Sessions will be scheduled 3 times/week with training parameters adjusted to progressively increase challenge as tolerated.
15922196|NCT03480568|Drug|Alirocumab 150 MG/ML [Praluent]|Cholesterol-lowering therapy
15922197|NCT03480555|Dietary Supplement|Replenish Protein|Subjects randomized to this group will receive 2 g of protein/kg/day (acceptable range as 1.8 - 2.2 g of protein/kg/day) for day 6-14.
15922198|NCT03480555|Dietary Supplement|Standard protein|Subjects randomized to this group will receive 0.8 - 1 g of protein/kg/day for day 6-14
15922199|NCT03480529|Drug|drug inducing arthritis, lupus, hepatitis, or capillary leak syndrom|Drugs susceptible to induce arthritis, lupus, hepatitis, or capillary leak syndrom
15922200|NCT03480516|Device|SDF|38% silver diamine fluoride solution
15922201|NCT03480516|Device|Fluoride varnish|5% sodium fluoride varnish
15922202|NCT03480490|Diagnostic Test|Pleural fluid C-reactive protein|"C-reactive protein is an acute phase protein that is synthesized by the liver in response to various stimuli.
~The pleural fluid c-reactive protein levels are likely to reflect the serum levels because the presence of c-reactive protein in the pleural fluid may be due to increased diffusion from the blood as a result of inflamed capillary leakage.
~Pleural c-reactive protein has been proposed as a specific biomarker for the differential diagnosis of pleural effusions and reportedly exhibits higher sensitivity and specificity than serum c-reactive protein.
~c-reactive protein can be considered a good candidate due to its 1000-fold elevation in response to infection and the positive correlation between the serum and pleural c-reactive protein levels.
~Pleural fluid c-reactive protein level was significantly higher in exudates than that in transudative effusion."
15922203|NCT03480477|Other|ACE questionnaire|No intervention is performed, patients will complete BRFSS Adverse Childhood experiences questionnaire
15922344|NCT03479307|Drug|Vehicle of Bilastine Ophthalmic Solution|1 drop in each eye at 2 separate times during an 8 day period.
15922204|NCT03480464|Behavioral|App-technology to increase physical activity|The application will send daily reminders to register and notices with information about the health benefit of physical activity, medication, supplementary vitamins and diet after surgery
15922205|NCT03480451|Other|Multi-Disciplinary Patient Centered Rehab and Education|"This project is being withdrawn. No revisions to Intervention is available.
~Patients will undergo consultation and education by members of a pre-determined multi-disciplinary team that aims to bring a predetermined set of services to the patient in a coordinated and scheduled manner in order to facilitate a comprehensive and through approach to the patient's entire well being"
15922206|NCT03480438|Drug|Blinatumomab|Patients will receive standard of care chemotherapy before blinatumomab, between blinatumomab cycles and after blinatumomab.
15922207|NCT03480425|Diagnostic Test|Measuring extubation force|Intubation of the esophagus of anesthetized participants who are having planned endotracheal intubate for surgery; inflation of the cuff; attachment of a force transducer to the tube connector; and gently tugging the tube out of the mouth. Then intubating the esophagus and repeating the tugging procedure. Meanwhile, the force of resistance to tugging is measured with a force transducer.
15922208|NCT03480412|Procedure|Follicular Phase|The follicular phase stimulation is conduced according to a standardized Antagonist protocol or Short protocol (with GnRH agonist) using recombinant or urinary gonadotropins (starting dose 300 or 450 UI) or a long lasting recombinant gonadotropin (Corifollitropin alfa 150 mcg) from the second day of the menstrual cycle. When at least two follicles had reached 17-18 mm in diameter, ovulation will be triggered with a single subcutaneous bolus of urinary human chorionic gonadotropin (10.000 UI ) and oocyte retrieval will be performed after 35 hours.
15922209|NCT03480412|Procedure|Luteal Phase|Two - six days after the first oocyte retrieval a second gonadotropin stimulation will be started with a GnRH antagonist protocol (the stimulation will be started with 250 UI of human menopausal gonadotropin (hMG) and a GnRH antagonist (GnRH-an) 0,25 mg\die will be administered when the leading follicle is ≥ 14 mm until hCG criteria are met). When at least two follicles had reached 17-18 mm in diameter, ovulation will be triggered with a single subcutaneous bolus of urinary human chorionic gonadotropin (10.000 UI ) and oocyte retrieval will be performed after 35 hours.
15922210|NCT03480386|Behavioral|Home Based Pulmonary Rehabilitation|The intervention consists of doing 12 weeks of exercises at home, with a weekly call from a health coach.
15922211|NCT03480360|Drug|Cyclophosphamide|14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4)
15922212|NCT03480360|Drug|Fludarabine|30 mg/m2 daily for 5 days
15922213|NCT03480360|Radiation|Total Body Irradiation|200 centigray (cGy) for one day (day -1)
15922214|NCT03480360|Drug|Tacrolimus|1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180.
15922215|NCT03480360|Drug|cellcept|dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation.
15922216|NCT03480360|Drug|g-csf|5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) > 1000/mcL for 3 days.
15922217|NCT03480360|Procedure|Peripheral Blood Transplant|cell dose goal: < 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight
15922218|NCT03480334|Other|Nivolumab plus radiotherapy|Nivolumab 240 mg i.v. at 2-weekly intervals combined with 20Gy radiotherapy (RT) to a preferably progressive and not pre-irradiated single lesion. Nivolumab will be continued for a maximum of 18 months or until disease progression or unacceptable toxicity.
15922219|NCT03480321|Drug|Cilostazol 100 mg|One immediately-release tablet (Cilostazol 100 mg) at 08:00 and another at 20:00, twice daily oral dose (total daily dose of 200 mg)
15922220|NCT03480321|Drug|PMR 150 mg|Two extended-release tablets (PMR 150 mg) at 08:00, single oral dose (total daily dose of 300 mg)
15922221|NCT03480321|Drug|PMR 200 mg|Two extended-release tablets (PMR 200 mg/tablet) at 08:00, single oral dose (total daily dose of 400 mg)
15922222|NCT03480308|Drug|Fentanyl|Patients will receive bupivacaine (0.5%) 20 ml , fentanyl 1 μg/kg in paravertebral block
15922223|NCT03480308|Drug|Dexamethasone|Patients will receive bupivacaine (0.5%) 20 ml , Dexamethasone 4mg in paravertebral block
15922224|NCT03480308|Drug|Bupivacaine|Bupivacaine
15922225|NCT03480295|Device|Hyaluronic acid 0.4% and Taurine 0.5%|4 drops /day in addition to the ongoing glaucoma treatment
15922226|NCT03480295|Device|Hyaluronic acid 0.2%|4 drops /day in addition to the ongoing glaucoma treatment
15922227|NCT03480282|Other|Prognosis information and Provider Scripts|An individualized report including each patient's prognosis will be calculated by the Lee-Schonberg and will include information on patient life expectancy from Cho et al.'s US life tables. This report will be sent to the PCP three days before the patient visit. Example scripts for PCPs to use with patients when discussing life expectancy and stopping cancer screening will be sent with the patient prognostic information.
15922228|NCT03480256|Drug|SHR6390|SHR6390 is a novel small molecule inhibitor specifically targeting the CDK4/6 pathway.Pyrotinib is an irreversible pan-ErbB inhibitor which shows promising antitumour activity in patients with HER2-positive metastatic gastric cancer
15922229|NCT03480243|Drug|Padsevonil (UCB0942)|"Pharmaceutical Form: film-coated tablet
~Route of Administration: Oral use"
15922230|NCT03480243|Drug|Erythromycin|"Pharmaceutical Form: film-coated tablet
~Route of Administration: Oral use"
15922231|NCT03480230|Drug|Compound 121564|Compound 121564 10 mg/Kg administered over 60 minutes given intravenously every 2 weeks for 4 doses plus chemotherapy depending on tumor histology.
15922232|NCT03480217|Behavioral|Multifaceted Implementation Strategy|"Key components include:
~educational presentations to primary care providers at grand rounds
~patient information materials on ABPM and HBPM
~training registered nurses to assist providers with teaching patients to conduct HBPM
~information on how to order ABPM and HBPM to clinicians, nurses and front desk staff via huddles, emails, and other electronic communications
~a computerized EHR-embedded clinical decision support tool that prompts providers to recall the USPSTF hypertension guidelines and facilitates ordering of HBPM and ABPM for guideline-eligible patients
~periodic feedback to primary care providers about clinic-level success with appropriately ordering ABPM and HBPM for eligible patients
~an accessible, culturally-adapted and locally tailored ABPM service"
15922233|NCT03480191|Drug|Daptomycin|Daptomycin will be given by intravenous infusion and administered over a 30 minutes infusion, daily, for 8 days and at the dosis of 10mg/kg/day.
15922799|NCT03475602|Diagnostic Test|TSHD7A|Determination of serum concentration of anti TSHD7A antibody
15922234|NCT03480165|Drug|Parecoxib 20 MG/ML|1 ml of injectable parecoxib (Dynastat®, Pfizer) at a concentration of 20 mg/mL is given concurrently with 19 ml of 0.75% ropivacaine (Naropin®, Astra Zeneca)
15922235|NCT03480165|Drug|Ropivacaine|19 ml of 0.75% ropivacaine (Naropin®, Astra Zeneca)) is given concurrently with 1 ml of normal saline
15922236|NCT03480152|Biological|National Cancer Institute (NCI)-4650, a messenger ribonucleic acid (mRNA)-based, Personalized Cancer Vaccine|Patients will receive a messenger ribonucleic acid (mRNA)-based vaccine intramuscularly at two-week intervals for four cycles (one course of treatment). Patients may be vaccinated with a second and final course of treatment using the same vaccine dose. The second course may start approximately four weeks (plus or minus 2 weeks) from the last vaccine dose of the first course.
15922237|NCT03480126|Dietary Supplement|Herbal Teas|Organic caffeine-free herbal tea
15922238|NCT03480113|Behavioral|Mindfulness-based Intervention|mindful breath, body scan, sitting meditation and walking meditation and so on.
15922239|NCT03480113|Behavioral|Physical fitness intervention|giving the lessons of stretch exercise, aerobics to strength muscle and lung fuctions.
15922240|NCT03480100|Drug|Xylometazoline Nasal Spray|Application of Xylometazoline Nasal Spray in accordance with the instructions for use
15922241|NCT03480100|Device|Ectoin Nasal Douche|Application of Ectoin Nasal Douche (END01) in accordance with the instructions for use
15922242|NCT03480074|Procedure|Staple Ligation|Using a stapler that staples the DVC and then cuts it.
15922243|NCT03480074|Procedure|Selective Suture Ligation|Suture the DVC, suspend it to the pubic bone, and then cut.
15922244|NCT03480074|Procedure|Single Suture Ligation|Cut the DVC, then pinpoint a specific blood vessel needed to sew/suture.
15922245|NCT03480061|Drug|Dexmedetomidine Hydrochloride Group|Dexmedetomidine will be initiated prior to transfer to the CVICU with loading dose of 1 ug kg-1 over approximately 20 minutes. This will be followed by an infusion at 0.1-1.0 ug kg-1h-1 in CVICU for up to 24 hours from the time DEX infusion started or until the patient is ready for discharge from the CVICU (whichever is earlier).
15922246|NCT03480048|Behavioral|Breastfeeding and weight loss support|The intervention is based on the Loving Support peer counseling breastfeeding model developed by the Special Supplemental Program for Women Infants and Children (WIC) with added components to promote postpartum weight loss.
15922247|NCT03480035|Procedure|lightwand intubation|intubation using lightwand
15922248|NCT03480022|Drug|Liraglutide Pen Injector [Saxenda]|daily sc injection of liraglutide with final dose of 3mg daily
15922249|NCT03480022|Drug|Placebo Liraglutide Pen Injector|daily sc injection of placebo liraglutide with final dose of 3mg daily of placebo
15922250|NCT03480009|Drug|Dextromethorphan Hydrobromide|Dextromethorphan capsule
15922251|NCT03480009|Drug|Avicel PH101 (Microcrystalline Cellulose NF) for Compounding|Placebo capsule
15922252|NCT03480009|Drug|Oxycodone|Participants may opt for the narcotic receiving arms of the study, before being randomized to dextromethorphan/placebo.
15922253|NCT03479996|Drug|Marcaine 0.5 % Injectable Solution|Intra -operative injection into obturator membrane
15922254|NCT03479983|Dietary Supplement|AMX160|500 mg Phyllanthus emblica L. fresh fruit extract capsules
15922255|NCT03479983|Dietary Supplement|Placebo|500 mg roasted rice powder in visually identical capsules
15922256|NCT03479970|Other|GNPT+ Social Cognition|Aplication of a computer based treatment focused on attention, memory, executive functions and social cognition.
15922257|NCT03479970|Other|GNPT|It's a computeritzed program of cognitive telerehabilitation
15922258|NCT03479957|Behavioral|REMOTE-CR|The patients randomized to remotely monitored exercise can either work out with self-selected activities e.g. Nordic-walking, cycling, skiing or participate in supervised exercise session via video link. Remotely monitored exercise training sessions will be offered monday-friday 13.00-16.00.
15922259|NCT03479957|Other|Control|The patients randomized to be controls will receive individualized information and instructions regarding current exercise recommendations but will not be monitored or coached during their exercise sessions (usual care)
15922260|NCT03479944|Procedure|FLACS|Femtosecond laser assisted cataract surgery consisting of LenSx® and Centurion® combination
15922261|NCT03479944|Procedure|Manual conventional surgery|Removal of cataractous lens by phacoemulsification
15922262|NCT03479944|Device|CENTURION® Vision System|Phacoemulsification aspiration platform for use during cataract surgery
15922263|NCT03479944|Device|LenSx®|Femtosecond laser system used for continuous curvilinear capsulorhexis (CCC) and lens fragmentation during cataract surgery
15922264|NCT03479931|Procedure|Without placement of a catheter|Elective cesarean section without preoperative placement of a urinary catheter.
15922265|NCT03479931|Procedure|With placement of a catheter|Elective cesarean section with preoperative placement of a urinary catheter.
15922266|NCT03479918|Drug|R-DA-EPOCH-21|R-DA-EPOCH-21 treatment without auto-SCT for HGBL DH and HGBL NOS patients younger than 60 years. Courses are repeated every 21 days.
15922267|NCT03479918|Drug|R-BL-M-04|R-BL-M-04 treatment without auto-SCT for HGBL DH and HGBL NOS patients younger than 60 years. Courses are repeated every 21 days.
15922268|NCT03479918|Drug|R-DA-EPOCH-21 + auto-SCT|R-DA-EPOCH-21 treatment with auto-SCT for HGBL DH and HGBL NOS patients younger than 60 years. Courses are repeated every 21 days.
15922269|NCT03479918|Drug|R-BL-M-04 + auto-SCT|R-BL-M-04 treatment with auto-SCT for HGBL DH and HGBL NOS patients younger than 60 years. Courses are repeated every 21 days.
15922270|NCT03479905|Other|Salter nasal cannula|Oxygen will be delivered by using standard nasal cannula
15922271|NCT03479905|Other|Face mask|Oxygen will be delivered via face mask during colonoscopy
15922272|NCT03479905|Device|High Flow Nasal Cannula|A high flow nasal cannula will be placed on the patient at a setting of FiO2 100% and titrated up to 60L/min depending on patient tolerance. 60 L/min is the max flow rate and will be used as tolerated for maximum benefit.
15922273|NCT03479892|Drug|NNC0194-0499|"Participants will receive NNC0194-0499 (s.c., in a lifted fold of the abdominal skin) injection once weekly at increasing doses of 3.0 mg, 9.0 mg, 27 mg, 60 mg, or 120 mg. Each participant will only be given one dose level.
~Dose escalation will proceed to the next planned dose level if there are no safety concerns raised by the investigator or by the trial safety group."
15922274|NCT03479892|Drug|Placebo|Participants will receive once weekly injections of NNC0194-0499 matched placebo.
15922275|NCT03479879|Drug|Estradiol|Estradiol
15922278|NCT03479866|Other|Dietary intervention|To carry out an interventional dietary study using standardised meals to predict for an individual their metabolic response to certain foods using the gut microbiome and their metabolic profile. Responses will include post-prandial appetite, levels of satiety, circulating glucose, insulin, ketone bodies and lipid levels.
15922279|NCT03479853|Procedure|Ophthalmologic examination and meibographic and interferometric evaluation (Lipiview device)|Classic ophthalmologic examination with visual acuity measurement and slit lamp examination of both eyes and eyelids. Then, meibographic and interferometric evaluation of his two inferior eyelids with the Lipiview device.
15922280|NCT03479840|Procedure|PCI|treatment of coronary arteries and evaluation of SYNTAX score pre and post (to quantify severity of disease)
15922281|NCT03479827|Device|Monofocal Contact Lens|A monofocal contact lens will be used for this measurement.
15922282|NCT03479827|Device|Bifocal Contact Lens|A bifocal contact lens will be used for this measurement.
15922283|NCT03479814|Radiation|IMRT-SIB plus sequential IG-RT boost|
15922284|NCT03479801|Procedure|Thyroid Surgical Methods|Different methods of thyroid surgery, including conventional open thyroidectomy, transoral endoscopic thyroidectomy via vestibular approach, and endoscopic thyroidectomy via breast approach.
15922285|NCT03479762|Drug|Liraglutide|No treatment given
15922286|NCT03479749|Device|RegenoGel-OSP, RegenoGel|RegenoGel-OSP (A) and RegenoGel (B) are visco-supplements intended for the intra-articular treatment of OA.
15922287|NCT03479736|Drug|Oral Fluoroquinolones (FQ)|Participants will not receive any intervention as a part of this study. The FQ include all oral forms of FQ (24-hours extended release tablets, extended release tablets, oral solution, oral suspension, oral tablet, pack). The drugs included are ciprofloxacin, gatifloxacin, gemifloxacin, levofloxacin, moxifloxacin, norfloxacin, ofloxacin.
15922288|NCT03479736|Drug|Other Antibiotics|Participants will not receive any intervention as a part of this study. Other antibiotics include amoxicillin, azithromycin, trimethoprim and trimethroprim/sulfamethoxazole.
15922289|NCT03479736|Other|Febrile Illness Not Treated with Antibiotics Will be Analyzed as an Exposure|Febrile illness not treated with antibiotics is defined as: concurrent diagnoses of viral disease with concurrent fever, and no concurrent prescription for any antibiotic during the 60-day period before and after the first date of viral disease diagnosis; or a diagnosis of influenza with no concurrent inpatient admission during the 60-day period pre- or post-influenza diagnosis, and no prescription for any antibiotics during the 60-day period pre- or post-influenza diagnosis.
15922290|NCT03479710|Biological|FMT infusion|Fecal microbiota transplantation via OGD
15922291|NCT03479697|Device|HIRREM|Technology
15922292|NCT03479697|Other|Continued Current Care|Continue their current clinical care.
15922293|NCT03479684|Other|Gene-directed dosage of warfarin|the first day given model prediction dose * 1.5 times（<6mg）；the second day given model prediction dose；adjusted dose based on INR from the third day
15922294|NCT03479684|Other|standard dosage of warfarin|the first day given 4.5mg; adjusted dose based on INR from the second day
15922295|NCT03479671|Drug|Intralipid, 20% Intravenous Emulsion|Fatty Acid Infusion, either in low-dose (30 ml/hr) or medium-dose (60 ml/hr)
15922296|NCT03479658|Behavioral|High intensity interval training|Two schools with four classes/groups of 4th degree of children will participate in the pilot study (i.e., age of children 9-10 years old). One of them has two physical education (PE) sessions per week and the other has only one PE session per week. In the school with two PE sessions, two classes will be randomly assigned to HIIT (2 sessions/week) +nutrition group, and two to the nutrition group. Similarly, in the school with one PE session per week, two classes will be randomly assigned to HIIT (1 session/week) + nutrition and two classes to the nutrition goup. Both HIIT and nutritional education sessions will be integrated integrated into the physical education and sciences sessions of the schools. The duration of the intervention will be of eight weeks.
15922297|NCT03479658|Behavioral|Nutritional education|School-based nutritional education on healthy dietary habits
15922298|NCT03479645|Behavioral|Serial text messages and mailed FIT kit|"Pre-alert SMS offering Opt-out of mailed FIT kit
~Mailed home FIT kit
~SMS A - Reciprocity message
~SMS B - Offer for second FIT kit if lost/did not receive
~Plus SMS A + C if second mailed FIT is requested.
~SMS C - Salience message"
15922299|NCT03479632|Behavioral|Aerobic walking program|Participants will make 24 visits over an 8 week period, having 3 sessions per week. Each session will last about one hour.
15922300|NCT03479632|Behavioral|Standard physical therapy|Participants will receive standard care they normally would after a stroke.
15922301|NCT03479619|Device|Lancing device A|Glucoject Dual Plus lancing device
15922302|NCT03479619|Device|Lancing device B|Droplet lancing device
15922303|NCT03479619|Device|Lancing device C|Commercially available lancing device
15922304|NCT03479619|Device|28 G lancet|Droplet 28 G
15922305|NCT03479619|Device|30 G lancet|Droplet personal lancet 30 G
15922306|NCT03479619|Device|33 G lancet|Droplet personal lancet 33 G
15922307|NCT03479619|Other|Lancing depth setting (1)|The lowest depth setting (1)
15922308|NCT03479619|Other|Lancing depth setting (5)|The highest depth setting (5)
15922309|NCT03479606|Behavioral|Online Emotion Regulation Skills-training|Emotion Regulation Training (EmReg) is a cognitive-behavioral approach which aims to increase awareness, and self-monitoring of affective states to improve self-regulation. The intervention is divided into two phases: knowledge provision and practice facilitation. During the knowledge provision phase participants are introduced to the objectives and the main concepts of the intervention, to increase their familiarity with the terminology, and to the emotion regulation skills they acquire during the practice facilitation phase. During the practice facilitation phase participants receive training in emotion regulation skills, which they practice in-session with the guidance of the therapist and feedback from the group, as well as out-of-session as homework assignments.
15922310|NCT03479593|Diagnostic Test|CMR and OCT in NSTEMI patients with MVD|Lesions >50% stenosis i patients with NSTEMI are examined by OCT. All patients will have CMR performed prior to angiography
15922311|NCT03479580|Other|Patients with a cardiomyopathy|Prognostic value of coronary artery disease and microvascular disease in the different types of cardiomyopathies.
15922312|NCT03479567|Other|Gait accelerometry|accelerometric assessment of gait (Dynaport Hybrid): 7m walk in 3 conditions (normal pace, fast, double task)
15922381|NCT03478969|Device|mylife™ OmniPod® Insulin Management System|A patch pump system delivering insulin.
15922313|NCT03479567|Other|balance accelerometry|accelerometric assessment of balance (Dynaport Hybrid) during 10 seconds trial in 3 conditions (side-by-side, semitandem, tandem)
15922314|NCT03479567|Other|Fine motor skill test|assessment of fine motor skills with Purdue Pegboard, with dominant hand, non-dominant hand and bimanual
15922315|NCT03479567|Diagnostic Test|Paratonia Assessment Instrument (PAI)|diagnosis of paratonia based on passive movement of the four limbs
15922316|NCT03479567|Other|myotonometric measurement of muscle tone|MyotonPRO measurement of muscle tone
15922317|NCT03479554|Other|Early antihypertensive treatment|"The CATIS 2 trial is designed to test BP reduction strategies-early antihypertensive treatment vs. delayed antihypertensive treatment-rather than test the efficacy of individual antihypertensive drugs. Several antihypertensive agents, including angiotensin-converting enzyme inhibitors, calcium channel blockers, and diuretics will be used in the trial.
~BP-lowering treatment will start immediately after randomization in the early antihypertensive treatment group. The target treatment goals are:
~Step 1 (within 24 hours after randomization): To lower systolic BP by 10-20% with an average of 15% (but systolic BP not lower than 130 mmHg and diastolic BP not lower than 80 mmHg) within the first 24 hours after randomization based on the participant's admission BP levels.
~Step 2 (within 5 days after randomization): To achieve systolic BP below 140 mmHg (but not lower than 120 mmHg) and diastolic BP below 90 mmHg (but not lower than 70 mmHg) and maintain this BP level afterward."
15922318|NCT03479554|Other|Delayed antihypertensive treatment|All home antihypertensive medications will be discontinued in the first seven days after randomization. Study participants will receive antihypertensive treatment on day eight after randomization and will target systolic BP <140 mmHg (but not lower than 120 mmHg) and diastolic BP <90 mmHg (but not lower than 70 mmHg) in two weeks. A BP check-up visit will be conducted in two weeks. If BP treatment goal is not achieved, antihypertensive medication will be titrated or a new medication will be added.
15922319|NCT03479541|Behavioral|Rehabilitation|"Participants will see a physiotherapist one-on-one twice per week for 2 weeks and once per week for 4 weeks for a total of 6 weeks. These sessions will consist of cardio, cervical flexion exercises and vestibule-ocular exercises for one hour. Participants will also have similar daily home exercises to complete for approximately 30 minutes. Both the one-on-one physiotherapy and home exercises will be individualized and progressive in the sense that each exercise can increase in the level of difficulty at the discretion of the physiotherapist depending on the performance of the participant.
~For the group allocated to home monitoring, they will perform the vestibular exercises while wearing one wireless sensor on the head and one on the sternum. When the participant brings the sensors in to the physiotherapy session each week, the physiotherapist will examine the home data and likely make a more informed decision as to whether or not to increase the level of difficulty of the task."
15922320|NCT03479515|Device|Ultrasound|Ultrasound, ADP, bioimpedance measurements
15922321|NCT03479502|Drug|Methylprednisolone Injectable Product|3 intra-articular injections of Methylprednisolone Injectable Product spaced every two weeks
15922322|NCT03479502|Drug|Doxycycline Injection|3 intra-articular injections of Doxycycline Injection spaced every two weeks
15922323|NCT03479489|Other|Human dehydrated amnion chorion allograft|Closed hemorrhoidectomy patched with dehydrated human amnion chorion allograft
15922324|NCT03479476|Drug|Placebo Medication|Placebo liquid or capsules given in parallel to active medication.
15922325|NCT03479476|Drug|Metformin|Active medication.
15922326|NCT03479463|Biological|Dehydrated human amnion/chorion membrane|Laryngectomy/pharyngectomy patched with dehydrated human amnion chorion allograft
15922327|NCT03479450|Drug|surfactant|surfactant is given when neonatal respiratory distress syndrome is diagnosed
15922328|NCT03479424|Other|Observational|The MYIA in-home suite of devices.
15922329|NCT03479411|Drug|Itraconazole Powder|Itraconazole administered as a dry powder for inhalation (PUR1900)
15922330|NCT03479411|Drug|Itraconazole 200 mg|Sporanox® Oral Solution
15922331|NCT03479398|Behavioral|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) is an evidence-based psychotherapy that treats a variety of disorders. In this study, clinicians will be enrolled who use types of CBT for anxiety disorders, depression and PTSD in their routine clinical practice. CBT is usually a 12-16 session treatment that focuses on intervening on disorders cognitively and behaviorally through the use of worksheets during session and outside of session.
15922332|NCT03479385|Behavioral|Integrative Medicine Intervention|Study participants will attend 14 sessions with an Integrative Medicine clinician over the course of 6 months, potentially followed by a 6 month maintenance phase.
15922333|NCT03479385|Behavioral|Health Education Intervention|Study participants will attend 14 sessions with a Health Educator over the course of 6 months.
15922334|NCT03479372|Drug|PAN-90806 Ophthalmic Suspension|PAN-90806 provided in single-use dropper bottles for topical ocular administration
15922335|NCT03479359|Behavioral|Routine review of DRE results by attending doctors|Let the internship regularly compare DRE result and the pathology outcome of prostate biopsy of each patient.
15922336|NCT03479346|Drug|GGT|Usage: 3g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
15922337|NCT03479346|Drug|Placebo|Usage: 3g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
15922338|NCT03479333|Device|Short implant|Short implant will be placed depending on the previous randomization. For that, a surgical access will be done, and the implant will be placed, cover screw will be installed and the access closed. The patient will receive the definitive crown after five months after the short implant installation.
15922339|NCT03479333|Device|Standard implant with sinus lift|First, a surgical access will be performed, followed by sinus lift procedure. Next, a standard implant will be placed, cover screw will be installed and the access closed. The patient will receive the definitive crown after five months after the short implant installation.
15922340|NCT03479320|Drug|Lidocaine|Postoperative analgesic effects will be compared between lidocaine and normal saline group
15922341|NCT03479320|Drug|Placebo|Postoperative anlagesic requirements will be calculated and compared with experimental group
15922342|NCT03479307|Drug|Bilastine Ophthalmic Solution 0.6%|1 drop in each eye at 2 separate times during an 8 day period.
15922343|NCT03479307|Drug|Ketotifen Ophthalmic Solution 0.025% (Zaditen)|1 drop in each eye at 2 separate times during an 8 day period.
15924156|NCT03465280|Procedure|Microdebrider|Removal of lesions via microdebrider
15922345|NCT03479294|Drug|Shenlingcao Oral Liquid|Shenlingcao Oral Liquid is a health product, and its main components are American ginseng, lucidum, Cordyceps fermented powder Cs-4, rose, maltitol and water. Shenlingcao Oral Liquid can relieve physical fatigue and enhance immunity.
15922346|NCT03479268|Drug|Ibrutinib|Given PO
15922347|NCT03479268|Other|Laboratory Biomarker Analysis|Correlative studies
15922348|NCT03479268|Drug|Pevonedistat|Given IV
15922349|NCT03479268|Other|Pharmacokinetic Study|Correlative studies
15922350|NCT03479268|Other|Pharmacological Study|Correlative studies
15922351|NCT03479255|Behavioral|Smartphone-enabled structured exercise therapy (SE-SET)|The SE-SET program lasts a total of 12 weeks per participant. During this time, the application will automatically track physical activity (steps) and subjects will be prompted to enter other health data such as blood pressure and weight, and watch brief educational videos on topics such as smoking cessation, low sodium diet, high fruit/vegetable intake, and medication adherence/education. Patients will be contacted by a member of the study team weekly via phone call in order to identify barriers to patient compliance (issues related to exercise tracking, medication issues that prevent patient from being active, high BP/weight issues) and help patients navigate those barriers. Movn participants can also send direct messages to the study team to ask about non-urgent issues related to their care.
15922352|NCT03479255|Behavioral|Standard exercise therapy|The Standard exercise therapy lasts a total of 12 weeks per participant. Participants will be counseled by the physician to perform exercise at home, including 3 times per week of walking 30+ minutes; if applicable, the physician will also counsel on smoking cessation, low sodium diet, high fruit/vegetable intake, and medication adherence/education. These patients will be given a fitness band, which will be set up by the study team using a de-identified study account that will provide additional data on their progress over time.
15922353|NCT03479242|Other|no interventions|no interventions are planned
15922354|NCT03479229|Device|Geneveve Treatment|The active treatment group will receive a treatment dose of 90 J/cm^2
15922355|NCT03479229|Device|Sham Treatment|The sham group will receive a sub-therapeutic dose of ≤ 1 J/cm^2.
15922356|NCT03479216|Drug|Precedex|10 ml of Bupivacaine ve 50mcg Dexmetedomidin mixture will be injected intraarticularly at the end of the surgery.
15922357|NCT03479216|Drug|Magnesium Sulfate|10 ml of Bupivacaine ve magnesium sulfate mixture will be injected intraarticularly at the end of the surgery.
15922358|NCT03479203|Drug|Electronic Cigarette Aerosol|16 two-second-long puffs from a non-nicotinized electronic cigarette.
15922359|NCT03479190|Procedure|ultrasound guided injection of Platelet rich plasma|Platelet rich plasma (PRP) injection into trochanteric area under ultrasound guidance
15922360|NCT03479190|Procedure|ultrasound guided injection of Normal Saline|ultrasound guided injection of Normal Salineinto trochanteric area under ultrasound guidance
15922361|NCT03479177|Behavioral|High Intensity Interval Training|The exercise sessions will be based on exercises the participant can confidentially engage in (regular push-ups vs. knee push-ups vs. wall push-ups). The goal will be to engage in three exercise sessions per week. The participants will receive weekly telephone calls during the first month and bi-weekly calls during months 2 and 3. The exercise counselor will also engage in dialogue that will motivate the participant to exercise.
15922362|NCT03479164|Other|Ultra Low-Dose CT|Ultra Low-Dose CT
15922363|NCT03479151|Device|Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU)|MRgHIFU treatment will be delivered using a Philips Sonalleve system, which integrates a high intensity phased array focused ultrasound transducer with our Philips 3T Achieva imaging system. An electromechanical transducer positioning system is used to deliver spatially and temporally controlled ultrasound energy and thermal heat to tissues non-invasively. The MR system is used to provide images to plan the therapy, and to guide and monitor the thermal ablation with thermal imaging during the treatment.
15922364|NCT03479138|Diagnostic Test|Induced sputum|Characterization with flow cytometry of the phenotype of the neutrophils isolated in the sputum, microbiome
15922365|NCT03479125|Diagnostic Test|Ultrasound|Subjects will be observed to estimate the adjusted event rate for hepatocellular carcinoma with or without cirrhosis previously treated with emricasan or placebo.
15922366|NCT03479112|Behavioral|Flashcards|Participants will be provided with Flashcards depicting how to correctly apply a tourniquet to an extremity wound.
15922367|NCT03479112|Behavioral|Audio-kit|Participants will be provided with an audio-kit with accompanying visual cues describing and depicting how to correctly apply a tourniquet to an extremity wound.
15922368|NCT03479112|Behavioral|B-Con training|Participants will undergo the Bleeding control for the injured (B-Con) basic course.
15922369|NCT03479112|Behavioral|B-Con training retention|Evaluation of retention of Bleeding Control for the injured basic course
15922370|NCT03479086|Drug|Topiramate|200mg/day 100mg b.i.d
15922371|NCT03479086|Drug|Naltrexone|50mg/day
15922372|NCT03479060|Procedure|Wet Cupping|cupping technique procedure was conducted in five phases:Primary suction,Area disinfection,Scarification,Bloodletting and secondary suction and Removing and dressing
15922373|NCT03479047|Diagnostic Test|assess diaphragmatic displacement (DD) using ultrasonography|During a spontaneous breathing trial (SBT) we will simultaneously, for all included patient, assess diaphragmatic displacement (DD) using ultrasonography, respiratory rate (RR) and tidal volume (VT) on ventilator screen.
15922374|NCT03479034|Other|ScalaMed ePrescription application|Mobile phone application (Android and Apple) for storing electronic prescriptions
15922375|NCT03479021|Diagnostic Test|Welch-Allyn Spot Vision Screener|photograph of the eye
15922376|NCT03479008|Diagnostic Test|Therapeutic Vibration Device|The Therapeutic Vibration Device is capable of applying force through the axial skeletal spine, through bidirectional compression loading (or prestressing) between the shoulder and the plantar surfaces of the feet. It is placed around the body like a mobile frame so that the applied vibration can affect the whole body. The vibration actuators (drivers) are mobile and can vary in size, frequency response, and force. The design minimizes the possibility of mechanical interference for ventilated/intubated patients.
15922377|NCT03478995|Drug|GX-I7|GX-I7 25mg/ml/vial
15922378|NCT03478982|Drug|Staccato Alprazolam|single dose for inhalation
15922379|NCT03478982|Drug|Placebos|single dose for inhalation
15922380|NCT03478969|Device|Accu-Chek® Solo micropump system|Medical device for subcutaneous delivery of insulin in a personalized way.
15922382|NCT03478969|Other|Multiple Daily Injections (MDI) therapy|Injecting insulin as per participant's need.
15922383|NCT03478956|Drug|Etrolizumab|Etrolizumab was administered by subcutaneous (SC) injection as described for each treatment arm.
15922384|NCT03478930|Drug|Omalizumab|Omalizumab will be administered as a subcutaneous (SC) injection Q2W or Q4W.
15922385|NCT03478930|Drug|Placebo|Participants will not be receiving placebo in this OLE study. Participants who were randomized to the placebo arms for 24 weeks in studies GA39688/GA39855 and then enter this OLE study will receive omalizumab, but they will be placed in separate analysis cohorts.
15922386|NCT03478904|Drug|Enzalutamide Liquid|Enzalutamide liquid formulation given orally (160mg)
15922387|NCT03478904|Drug|Enzalutamide Capsule|Enzalutamide gel capsule (4X 40mg)
15922388|NCT03478891|Biological|VRC-EBOMAB092-00-AB (MAb114)|VRC-EBOMAB092-00-AB (MAb114) is a human immunoglobulin (IgG1) monoclonal antibody (MAb) targeted to the Zaire ebolavirus (EBOV) glycoprotein (GP).
15922389|NCT03478878|Drug|Vitamin A Palmitate|Provide vitamin A to participants with pre /post assessments of vision.
15922390|NCT03478865|Drug|Vitamin A palmitate|Provide vitamin A to participants with pre/post assessments of vision.
15922391|NCT03478826|Other|ILD|100 cc of blood collected from a total of 250 ILD patients. This includes IPF (n=100), fibrotic NSIP (n=50), chronic hypersensitivity pneumonia (n=20), sarcoidosis(n=50), progressive rheumatoid lung disease (n=10) and scleroderma lung disease (n=20)), 10 patients with other fibrosing disease (fibrosing mediastinitis), and 50 patients with lymphangioleiomyomatosis
15922392|NCT03478826|Other|Healthy|100 cc of blood collected from a total of 25 healthy volunteers in order to compare with the ILD participants.
15922393|NCT03478826|Other|Pneumonia|100 cc of blood collected from a total of 100 participants with a diagnosis of pneumonia in order to compare with the ILD participants.
15922394|NCT03478813|Behavioral|Voiding school|Children are educated on the kidneys, bladder and bowel function, the importance of regular voiding and drinking habits, and avoidance of constipation. Balloons, books, videos, animations, the pictures of a satisfied and irritated bladder and a poo-cars formula track are used to exemplify the function of urinary and defecation systems. During toilet visits children are given advise about an adequate and relaxed toilet posture with the help of little bench under the feet if needed. Each child also make their own timetable for peeing, pooing, and water drinking times, which they then should learn to follow in day-care, pre-school and at home. At the end of each session child, parent and public health nurse/urotherapist discuss any individual advice and the homework for the next time.
15922395|NCT03478800|Procedure|Acupuncture|Each treatment would take approximately 15-20 minutes and would take place immediately after practice for a total of five treatments. The needles are standard (0.2mm diameter #36 gauge 1 inch stainless steel) and during each treatment, 3-6 needles would be placed in the lower extremity in any of the following muscle groups: quadriceps, hamstrings, anterior tibialis, gastrocnemius-soleus complex, medial head of the gastrocnemius, peroneal muscles, or iliotibial band. The athletes would complete brief pre- and post-treatment surveys.
15922396|NCT03478787|Drug|risankizumab|Subcutaneous (SC) injection
15922397|NCT03478787|Drug|secukinumab|Subcutaneous (SC) injection
15922398|NCT03478774|Drug|Oxygen 70l/min|HFNCT will be provided using OptiFlow by Fisher&Paykel.
15922399|NCT03478774|Drug|Oxygen 10 l/min|Medium flow will be applied with a humidifier (Hudson RCI) and a standard nasal cannula.
15922400|NCT03478774|Drug|Oxygen 2l/min|Low flow will be applied with a humidifier (Hudson RCI) and a standard nasal cannula.
15922401|NCT03478774|Procedure|Jaw thrust|Continuous
15922402|NCT03478774|Procedure|Videolaryngoscopy|Continuous
15922403|NCT03478774|Drug|oxygen 0.25l/min|0.25l/min of oxygen via an endotracheal tube
15922404|NCT03478748|Other|Dental health education|Anticipatory guidance given to mothers to promote their children's oral health.
15922405|NCT03478735|Procedure|Ultrasound Guided Greater Occipital Nerve Block at C2|Ultrasound guided injection
15922406|NCT03478735|Procedure|Landmark-Based Greater Occipital Nerve Block|Traditional landmark-guided technique at the superior nuchal line. This approach relies solely on superficial bone-based anatomic landmarks to infiltrate local anesthetic and corticosteroid around the nerve at the level of the superior nuchal line.
15922407|NCT03478722|Other|Protein Meal|Ingestion of mixed meal containing 20 g of dietary protein
15922408|NCT03478722|Other|Stable Isotope Amino Acid Infusion|Continuous infusion of L-[1-13C]leucine (0.13 μmol⋅kg⋅min) and L-[ring- 2H5]phenylalanine (0.05 μmol⋅kg⋅min)
15922409|NCT03478709|Other|volume expansion|Volume expansion when the patient has a dependent preload evaluated by a positive leg lever test (variation of more than 10% of the VES). It corresponds to the intravenous administration of 500 ml of Ringer lactate over 10 min.
15922410|NCT03478709|Other|norepinephrine|Vasopressor agent when the patient has persistent arterial hypotension related to postoperative vasoplegia syndrome. Norepinephrine is administered during persistent hypotension (MAP <60mmHg) despite volume expansion. It corresponds to continuous intravenous norepinephrine administration to obtain a MAP of more than 70 mmHg
15922411|NCT03478696|Drug|budesonide/formoterol|Subjects will be administered two inhalations of budesonide/formoterol via MDI twice daily
15922412|NCT03478696|Drug|albuterol/salbutamol|Subjects will be provided short-acting albuterol/salbutamol as-rescue medication to be used on an as-needed basis throughout the study.
15922413|NCT03478696|Drug|FF/UMEC/VI|Subjects will receive FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning
15922414|NCT03478696|Drug|Placebo to match budesonide/formoterol|Subjects will be administered two inhalations of matching placebo twice daily via MDI
15922415|NCT03478696|Drug|tiotropium|Subjects will receive tiotropium (18 mcg) once daily in the morning via HandiHaler device
15922416|NCT03478696|Drug|Placebo to match FF/UMEC/VI|Matching placebo to FF/UMEC/VI will be administered via ELLIPTA once daily in the morning.
15922417|NCT03478696|Drug|placebo to match tiotropium|Subjects will receive tiotropium matching placebo via Handihaler once daily in the morning
15922418|NCT03478696|Device|ELLIPTA|Subjects will receive FF/UMEC/VI 100/62.5/25 mcg and matching placebo via ELLIPTA in the treatment period. Budesonide/formoterol plus tiotropium once daily plus placebo will be administered via ELLIPTA during the run-in period.
15922419|NCT03478696|Device|MDI|Subjects will receive budesonide/formoterol and placebo to match budesonide/formoterol via MDI in the treatment period.
15922420|NCT03478696|Device|HandiHaler|Subjects will be administered tiotropium (18 mcg) or placebo to match tiotropium via HandiHaler during the treatment period.
15922421|NCT03478683|Drug|budesonide/formoterol|Subjects will be administered two inhalations of budesonide/formoterol via MDI twice daily
15922422|NCT03478683|Drug|albuterol/salbutamol|Subjects will be provided short-acting albuterol/salbutamol as-rescue medication to be used on an as-needed basis throughout the study.
15922423|NCT03478683|Drug|FF/UMEC/VI|Subjects will receive FF/UMEC/VI 100/62.5/25 mcg via ELLIPTA once daily in the morning
15922424|NCT03478683|Drug|Placebo to match budesonide/formoterol|Subjects will be administered two inhalations of matching placebo twice daily via MDI
15922425|NCT03478683|Drug|tiotropium|Subjects will receive tiotropium (18 mcg) once daily in the morning via HandiHaler device
15922426|NCT03478683|Drug|Placebo to match FF/UMEC/VI|Matching placebo to FF/UMEC/VI will be administered via ELLIPTA once daily in the morning.
15922427|NCT03478683|Drug|placebo to match tiotropium|Subjects will receive tiotropium matching placebo via Handihaler once daily in the morning
15922428|NCT03478683|Device|ELLIPTA|Subjects will receive FF/UMEC/VI 100/62.5/25 mcg and matching placebo via ELLIPTA in the treatment period. Budesonide/formoterol plus tiotropium once daily plus placebo will be administered via ELLIPTA during the run-in period.
15922429|NCT03478683|Device|MDI|Subjects will receive budesonide/formoterol and placebo to match budesonide/formoterol via MDI in the treatment period.
15922430|NCT03478683|Device|HandiHaler|Subjects will be administered tiotropium (18 mcg) or placebo to match tiotropium via HandiHaler during the treatment period.
15922431|NCT03478670|Genetic|Strimvelis|Strimvelis is a CD34+ cell enriched dispersion of human autologous bone marrow derived hematopoietic stem/progenitor cells transduced with a retroviral vector containing the human ADA gene. It will be administered as an intravenous infusion once only.
15922432|NCT03478657|Drug|Placebo DPI|Subjects will receive placebo via oral inhalation route using ELLIPTA once daily. Placebo DPI will be available in two strips of 30 blisters per strip. First strip will contain lactose monohydrate and second strip will have lactose monohydrate blended with magnesium stearate.
15922433|NCT03478657|Device|ELLIPTA DPI|Subjects will receive placebo DPI via ELLIPTA. ELLIPTA is trademark of GSK
15922434|NCT03478657|Other|Ease of use questionnaires|Subjects from both stratum after use of ELLIPTA DPI will be randomized to receive either version A or B of the questionnaires. Subjects will be asked questions on ease of use of ELLIPTA. Parent/guardian will also complete a questionnaire about the ELLIPTA DPI.
15922435|NCT03478644|Device|Experimental Denture Wipe|Participants were instructed to use the experimental wipe to clean their dentures, external to their mouth, up to 4 times daily (once after completion of each of their three main meals and once at any other time) for 14 days. Participants were instructed to use one wipe per denture.
15922436|NCT03478644|Other|Tap Water|Participants were instructed to use running tap water to clean their dentures up to 4 times daily (once after completion of each of their three main meals and once at any other time) for 14 days.
15922437|NCT03478631|Other|High-nitrate dehydrated vegetable powder|A mixed combination of vegetable powders that are naturally high in nitrate content, such as beet, spinach, and kale
15922438|NCT03478631|Other|Low-nitrate dehydrated vegetable powder|A mixed combination of vegetable powders that are naturally low in nitrate content, such as peas, tomato, broccoli, carrots, and brussel sprouts
15922439|NCT03478618|Drug|Lactated Ringer|"Patients will be divided into 2 groups according to the amount of fluids received during caesarian section under spinal anesthesia.
~Group (R) 30 patients will receive 15ml/kg/h lactated Ringer (LR) intraoperative. Group (L) 30 patients will receive 30ml/kg/h lactated Ringer (LR) intraoperative. blood loss will be replaced if more than 500 ml in ratio 3 ml crystalloid : 1ml blood in both groups"
15922440|NCT03478605|Drug|Olanzapine|Olanzapine 5 mg/day will be administered orally on days 0-4 of chemotherapy cycle (before bedtime)
15922441|NCT03478605|Drug|Aprepitant Pill|Aprepitant 125 mg orally will be administered on day 1 of chemotherapy cycle; 80 mg - on days 2 and 3.
15922442|NCT03478605|Drug|Ondansetron|Ondansetron 16 mg IV on day 1 of chemotherapy cycle (as standard component of antiemetic therapy)
15922443|NCT03478605|Drug|Dexamethasone|Dexamethasone 8 mg IV on day 1 of chemotherapy cycle; 8 mg IV or orally on days 2-3 (as standard component of antiemetic therapy)
15922446|NCT03478579|Other|observational|No intervention, it is observational study
15922447|NCT03478566|Device|Transcutaneous CO2 monitoring|The aim is to assess the accuracy of ambulatory, at home, transcutaneous CO2 monitoring in pediatric Neuromuscular Disease (NMD).
15922448|NCT03478553|Other|High Resolution CT scan of the chest|High Resolution CT scan of the chest
15922449|NCT03478553|Other|Blood draw|Blood draw
15922450|NCT03478553|Other|Questionnaire|Pulmonary Fibrosis Questionnaire
15922451|NCT03478540|Drug|Anti-Retroviral Agents|First line antiretroviral therapy as recommended in China, e.g. tenofovir lamivudine and efavirenz
15922452|NCT03478527|Dietary Supplement|Vivomixx® powder|Participants will take in a daily dose of 4.4g for 28 consecutive days
15922453|NCT03478527|Other|Placebo powder|Participants will take in a daily dose of 4.4g for 28 consecutive days
15922454|NCT03478514|Drug|Palbociclib|Taken at 100 mg once daily for 21 days, followed by 7 days off
15922455|NCT03478514|Drug|Ibrutinib|560 mg taken orally all patients throughout the study
15922456|NCT03478501|Behavioral|Decision Aid|This intervention is a tablet based Lethal Means Decision Aid with proposed use to augment lethal means counseling in emergency departments for patients at risk of suicide.
15922457|NCT03478488|Drug|KN035 plus Gemcitabine & oxaliplatin|KN035 a programmed death ligand immune check inhibitor Per Investigator decision
15922458|NCT03478488|Drug|Gemcitabine & oxaliplatin|The standard of care for the patients with unresectable/metastatic biliary tract cancer
15922459|NCT03478475|Dietary Supplement|cholecalciferol (Euro-Pharm International, Canada)|
15922460|NCT03478475|Other|Placebo|Placebo pill (microcrystalline cellulose 66.3%, starch 33.2%, magnesium stearate 0.5%)
15922461|NCT03478462|Drug|CLR 131|IV dose of CLR 131, increased/decreased by dose level; single or fractionated dose
15922462|NCT03478449|Procedure|lymph node sorting for pathological examination|In this study, intervention methods include two kinds of lymph node sorting for pathological examination in gastric cancer samples after curative surgery. One is the fine sorting lymph nodes, representing the lymph nodes should be sorted one by one from the tissues around the stomach, celiac axis, and the main brunches of celiac axis. The other is the group sorting lymph nodes, representing the lymph nodes should be simply sorted in the soft tissues around the stomach, celiac axis, and the main brunches of celiac axis.
15922463|NCT03478436|Drug|Doxycycline|Doxycycline 40 mg capsules
15922464|NCT03478423|Drug|Codeine|30mg tablets. Patients will be instructed to take 1 tablet every 4 hours as needed for moderate to severe pain if you continue to have pain despite taking acetaminophen.
15922465|NCT03478423|Drug|Oxycodone|5mg tablets. Patients will be instructed to take 1 tablet every 4 hours as needed for moderate to severe pain if you continue to have pain despite taking acetaminophen.
15922466|NCT03478423|Drug|Hydromorphone|1mg tablets.Patients will be instructed to take 1 tablet every 4 hours as needed for moderate to severe pain if you continue to have pain despite taking acetaminophen.
15922467|NCT03478410|Procedure|Epicardial fat biopsy|A 1 cm (~0.5 g) of epicardial pat biopsy from the area of the pulmonary artery
15922468|NCT03478397|Other|Multicomponent mHealth Intervention|Women with HPV self-collected tests will receive a multicomponent intervention which includes SMS text messages to remind them to attend triage. In addition, CHWs will receive reminders via e-mails to contact women if after 60 days from the HPV-results HPV+ they have not performed triage
15922469|NCT03478384|Behavioral|Patient coaching|Patients receive regular coaching to test if the coaching alters their perceived self-efficacy.
15922470|NCT03478371|Device|tampon D|regular absorbency tampon
15922471|NCT03478371|Device|tampon M|regular absorbency tampon
15922472|NCT03478371|Device|tampon T|regular absorbency tampon
15922473|NCT03478371|Device|tampon V|regular absorbency tampon
15922474|NCT03478358|Drug|177Lu-DOTA-EB-TATE 1|The patients were intravenously injected with single dose 0.37GBq-0.74GBq (10-30 mCi) of 177Lu-DOTA-EB-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment.
15922475|NCT03478358|Drug|177Lu-DOTA-TATE|The patients were intravenously injected with single dose 3.7GBq (100 mCi) of 177Lu-DOTA-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment.
15922476|NCT03478358|Drug|177Lu-DOTA-EB-TATE 2|The patients were intravenously injected with single dose 1.85GBq (50 mCi) of 177Lu-DOTA-EB-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment.
15922477|NCT03478358|Drug|177Lu-DOTA-EB-TATE 3|The patients were intravenously injected with single dose 3.7GBq (100 mCi) of 177Lu-DOTA-EB-TATE and underwent 68Ga-DOTATATE PET/CT scans before and after the treatment.
15922478|NCT03478345|Behavioral|endocrine disruptor chemical reduction intervention|Participants will take part in a 4-week intervention consisting of a modified (shortened) version of the Diabetes Prevention Program diet and physical activity group education program, with instructions to reduce endocrine disruptor chemical exposure through changes in food handling and personal care products.
15922479|NCT03478332|Drug|Yangxinshi pill|0.6g/tablet
15922480|NCT03478332|Drug|conventional coronary heart disease medicine|the conventional treatment includes medicines treating coronary heart disease
15922481|NCT03478332|Drug|Placebos|Yangxinshi simulant
15922482|NCT03478319|Drug|ACE-2494 or placebo|Recombination fusion protein
15922483|NCT03478306|Drug|Melatonin 4 mg Tablet|Participants are randomized into arm 1 or arm2, recieving melatonin or placebo, respectively, for 21 days, followed by 1 week of washout, and then swichting to the contralateral treatment arm.
15922484|NCT03478293|Device|iStent inject surgery|Micro-invasive glaucoma surgery (MIGS) to implant iStent inject
15922485|NCT03478280|Drug|Brodalumab|Subjects with moderate-to-severe psoriasis are enrolled consecutively and randomly assigned to either active treatment with brodalumab or placebo during the treatment period
15922486|NCT03478280|Drug|Placebos|Subjects with moderate-to-severe psoriasis are enrolled consecutively and randomly assigned to either active treatment with brodalumab or placebo during the treatment period
15922487|NCT03478267|Diagnostic Test|AChE levels|AChE levels in peripheral blood tests from maternal blood, fetal umbilical cord and placenta.
15922488|NCT03478254|Biological|Influenza vaccination|"Correct influenza vaccination status was considered in the following situation:
~- Received at least one Influenza vaccine dose in the last year."
15922489|NCT03478254|Biological|Pneumococcal vaccination|"Correct pneumococal vaccination status was considered if a subject received at least one of the following options:
~One pneumococcal conjugate vaccine (PCV) 13 dose in the last year.
~One PCV13 dose following a pneumococcal polysaccharide vaccine (PPSV) 23 dose between the following 8 weeks and 12 months.
~One PPSV 23 dose in the last 5 years.
~One PPSV23 dose in the last 5 years and a second PPSV23 dose at 5 years or PCV13 at 1 year."
15922490|NCT03478254|Biological|Hepatitis B Virus (HBV) vaccination|"Correct Hepatitis B Virus (HBV) vaccination status was considered in the following situation:
~.- Received at least three consecutive doses of HBV vaccine during six consecutive months."
15922491|NCT03478241|Device|Group 1: single file rotary motion|after the previous root canal filling was removed, the shaping procedure of the root canal system was carried out using OneShape Ni-Ti system. the obturation process was completed prior to coronal restoration either with direct or indirect methods
15922492|NCT03478241|Device|Group 2: multiple file rotary motion|after the previous root canal filling was removed, the shaping procedure of the root canal system was carried out using Revo S Ni-Ti system. the obturation process was completed prior to coronal restoration either with direct or indirect methods
15922493|NCT03478241|Device|Group 3: single file reciprocal motion|after the previous root canal filling was removed, the shaping procedure of the root canal system was carried out using WaveOne Ni-Ti system. the obturation process was completed prior to coronal restoration either with direct or indirect methods
15922494|NCT03478228|Other|Multi-Sensory Training|
15922495|NCT03478215|Biological|Mesenchymal Stromal Stem Cells (MSCs) Infusion|"Investigational infusion bag containing autologous mesenchymal stromal cells wrapped to cover contents to maintain the blind.
~Mesenchymal Stromal Stem Cells Infusion."
15924157|NCT03465280|Procedure|Cold-steel surgery (forceps)|Removal of lesions via forceps
15922496|NCT03478215|Other|Normal Saline (Placebo) Infusion|"Matching infusion containing normal saline wrapped to cover contents to maintain the blind.
~Normal Saline (Placebo) Infusion."
15922497|NCT03478202|Dietary Supplement|GOLO RELEASE|GOLO RELEASE plus Diet
15922498|NCT03478189|Procedure|use of O-arm surgical imaging|during acetabular fracture surgery , use of O-arm surgical imaging with
15922499|NCT03478163|Drug|CeFAZolin 1000 MG|Cefazolin 1000 mg every 8 hours for 3 doses
15922500|NCT03478163|Drug|Clindamycin 900 MG in 6 ML Injection|Clindamycin 900 mg every 8 hours for 3 doses
15922501|NCT03478150|Other|zinc oxide nano-particles|The zinc oxide nano-powder will be mixed with ethanol
15922502|NCT03478150|Device|laser diode|The laser light is transferred through a 600µm flexible fiber optic tip by a special hand piece. the output power will be adjusted at 1.5W.
15922503|NCT03478137|Behavioral|CPAP intervention|Participants who agree to participate will be evaluated by a sleep specialist who will confirm eligibility for CPAP treatment.Eligible participants will be referred to VitalAire for initiation of treatment following a standard protocol for CPAP use at home. CPAP treatment will continue until the next visit for the main study, between 4-7 months, based on the timing of the evaluations, after which the study will end.
15922504|NCT03478124|Behavioral|Cognitive evaluation|An extensive battery of neuropsychological and motor tests was assessed: MMSE, FAB, MoCA, WCST, Stroop Test, TMT-A and B, Verbal fluency Test, ROCF copy and delayed recall, RAVLT, 6MWT, TUG, BBS.
15922505|NCT03478111|Drug|CMAB008|the study drug
15922506|NCT03478111|Drug|MTX|basic therapy drug
15922507|NCT03478111|Drug|Remicade|active comparator
15922508|NCT03478098|Other|Low GI mealtest|Meal with low glycaemic index (GI) is consumed over 20 min
15922509|NCT03478098|Other|Low GI mealtest and subsequent exercise|Meal with low glycaemic index (GI) is consumed over 20 min and the subject postprandially exercises for 30 min
15922510|NCT03478098|Other|High GI mealtest|Meal with high glycaemic index (GI) is consumed over 20 min
15922511|NCT03478098|Other|High GI mealtest and subsequent exercise|Meal with high glycaemic index (GI) is consumed over 20 min and the subject postprandially exercises for 30 min
15922512|NCT03478085|Other|Oxygen guided exercise therapy|Subjects exercise to a certain intensity based on 15% muscle oxygen desaturation.
15922513|NCT03478072|Device|trichoscopy|hair and scalp dermoscopy) is a non-invasive technique in which either a handheld dermoscope or a digital videodermoscope can be used to visualize hair and scalp structures
15922514|NCT03478059|Behavioral|Cognitive and Motor Dual-task Intervention|The intervention will take place 3 times per week for 6 weeks (60 minutes/session) and employs motor and cognitive challenges. It is based on known motor and cognitive deficits after mTBI and is structured using a theoretical framework published in another domain of neurologic disease. The intervention will consist of 6 stations that target known motor and cognitive impairments after mTBI. Each station will have 3 levels of difficulty with optional cognitive progressions. Subjects will spend 8 minutes at each station with a 2 minute transition/rest period between stations and will be progressed in motor and cognitive difficulty as able.
15922515|NCT03478046|Other|Weight loss|Compare the total and temporal changes in fetuin-A phosphorylation and insulin resistance that occur with an 8 to 10% weight loss induced by chronic exercise training and dietary modification
15922516|NCT03478033|Drug|Rifampicin|Rifampicin capsules, 150mg
15922517|NCT03478033|Drug|Rifabutin|Rifabutin capsules, 150mg
15922518|NCT03478020|Drug|AQX-1125|Investigational Drug
15922519|NCT03478020|Drug|Combined Oral Contraceptive|COC containing 100 ug Levonorgestrel (LNG) and 20 ug Ethinyl Estradiol (EE)
15922520|NCT03478007|Device|Intervention Technology|Subjects will perform their exercises using the provided monitoring device. They will be able to contact the investigators with questions regarding the use of the monitoring device, however, no encouragement or coaching will be provided
15922521|NCT03478007|Device|Intervention Technology Plus Coaching|Subjects will perform their exercises using the provided monitoring device. They will also be coached by a trained health coach through a weekly call.
15922522|NCT03477994|Drug|Dexmedetomidine|an infusion of 0.5-0.7 μg/kg/h then 1.4 μg/kg/h if Richmond assessment sedation score from +1 to +4 ,if the heart rate less than 60 per minute or persistent hypotension reduce infusion rate by 0.2 μg/kg/h.
15922523|NCT03477994|Drug|Clonidine|an infusion of 0.5μg/kg then 0.1-0.2 μg/kg/h if Richmond assessment sedation score from +1 to +4.
15922524|NCT03477981|Other|Alginate bread|White bread with 4% alginate (wet weight of dough) included into the bread.
15922525|NCT03477968|Other|Plasma sampling|Additional blood draw or additional volume during blood draw
15922526|NCT03477955|Procedure|PEEK interspinous spacer|To study the Adjacent Segment Degeneration incidence in the supradjacent segment following short lumbar fusion between PEEK and Silicon Interspinous spacers.
15922527|NCT03477942|Biological|Autologous Mesenchymal Stem Cells|Bone marrow will be harvested from each individual patient's iliac crest, followed by stem cell isolation, expansion and preparation. Stem cell will be injected approximately 3-4 weeks after bone marrow harvest, injecting 50x10^6 MSCs in the knee via a medial parapatellar approach under sterile technique in 8 patients with generalized knee OA or focal chondral defects.
15922528|NCT03477929|Drug|Ganirelix Acetate|multiple dose of Ganirelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met
15922529|NCT03477929|Drug|Cetrorelix Acetate|multiple dose of Cetrorelix acetate (0.25mg) are administered when the lead follicle is ≥ 14 mm until hCG criteria are met
15922530|NCT03477916|Biological|FMT|fecal microbial transplantation (FMT)
15922531|NCT03477916|Biological|Placebo FMT|Placebo fecal microbial transplantation (FMT)
15922532|NCT03477916|Dietary Supplement|Prebiotic Fiber|combined fiber supplement of resistant starch type 4, acacia gum, and soluble corn fiber
15922533|NCT03477916|Dietary Supplement|Cellulose|Cellulose
15922534|NCT03477903|Drug|TAK-954|TAK-954 infusion
15922535|NCT03477903|Drug|Metoclopramide|Metoclopramide infusion
15922536|NCT03477903|Drug|Normal Saline|0.9% sodium chloride for injection
15922558|NCT03477760|Biological|rectal swab for Multi-Drug resistant bacteria|A rectal swab will be performed at admission of patients to look for intestinal carriage of Multi-Drug resistant bacteria
15922627|NCT03477110|Device|NovoTTF-200A Device|Undergo tumor treatment fields therapy using NovoTTF-200A device
15922537|NCT03477890|Diagnostic Test|Stratified medicine involving a diagnostic intervention|"Adjunctive tests of coronary artery lesion severity (fractional flow reserve) and function at the time of invasive coronary angiography. Diagnostic groups: stable coronary syndromes in patients with obstructive coronary artery disease (mis-classified by non-invasive CTCA) or no-obstructive coronary disease including the following sub-groups (coronary artery vasospasm, microvascular spasm, impaired vasorelaxation due to (1) endothelial dysfunction and/or (2) non-endothelial dysfunction, or unaffected (normal test results).
~Medical management is linked to contemporary clinical guidelines for the management of patients with stable coronary artery disease (European Society of Cardiology (2013), Scottish Intercollegiate Guideline Network (SIGN), 2017)."
15922538|NCT03477890|Diagnostic Test|Stratified medicine involving a diagnostic intervention|"Adjunctive tests of coronary artery lesion severity (fractional flow reserve) and function at the time of invasive coronary angiography. Diagnostic groups: stable coronary syndromes in patients with obstructive coronary artery disease (mis-classified by non-invasive CTCA) or non-obstructive coronary disease including the following sub-groups (coronary artery vasospasm, microvascular spasm, impaired vasorelaxation due to (1) endothelial dysfunction and/or (2) non-endothelial dysfunction, or unaffected (normal test results).
~Medical management is linked to contemporary clinical guidelines for the management of patients with stable coronary artery disease (European Society of Cardiology (2013), Scottish Intercollegiate Guideline Network (SIGN), 2017)."
15922539|NCT03477877|Behavioral|Indashyikirwa Couples Training|A training curriculum for heterosexual couples in Rwanda comprising 20 3-hour modules (60 hours total) delivered to groups of 15 couples (30 people). Each module facilitated by male and 1 female facilitator. Curriculum topics include: types and uses of personal and interpersonal power (power within, power over, power with, power to), gender, gender based violence, triggers for intimate partner violence, conflict management, economic development, sexuality, alcohol, social norms and community change. Delivered by RWAMREC.
15922540|NCT03477877|Behavioral|Indashyikirwa Activist Training|This training is offered to a subset of individuals who complete the couples curriculum (randomly selected from among those who are are willing and eligible). These individuals are trained to serve as community activists, teach peers about the types of power (power within, power over, power with, power to), and advocate for community change to prevent intimate partner violence. Delivered by RWAMREC.
15922541|NCT03477877|Behavioral|Indashyikirwa Opinion Leader Training|"Training delivered to opinion leaders (political office holders, religious leaders, service providers), in intervention communities. Training comprised 8 x 3 hour sessions (24 hours) delivered for groups of up to 40 participants. Introduces Opinion Leaders to the concepts of power (power within, power over, power with, power to) and to essential concepts around women's legal rights. Delivered by Rwanda Women's Network."
15922542|NCT03477877|Other|Indashyikirwa Women's Spaces|"Establishment of 1 Women's Space per intervention sector -- a physical space with trained facilitators on duty from which support and referrals for women experiencing IPV could be offered and ad hoc programming responsive to community needs and interest can be run. Typical activities include once-off open trainings for community members on the concepts of power (power within, power over, power with, power to), essential concepts around women's legal rights, conflict management in families, etc. Delivered by Rwanda Women's Network."
15922543|NCT03477877|Behavioral|Village Savings and Loan Association (VSLA)|A standard Village Savings and Loan Association program as run nationwide by CARE Rwanda.
15922544|NCT03477864|Biological|Ipilimumab|Given via intraprostatic injection
15922545|NCT03477864|Radiation|Stereotactic Body Radiation Therapy (SBRT)|Undergo SBRT
15922546|NCT03477864|Procedure|Radical Prostatectomy|Undergo radical prostatectomy
15922547|NCT03477864|Biological|Anti-PD-1 Monoclonal Antibody REGN2810|Given IV
15922550|NCT03477838|Device|FreeStyle LibrePro CGM|a professional CGM device will be worn by the participant for up to 14 days
15922551|NCT03477825|Dietary Supplement|Placebo Oral Tablet|"Group A: Placebo group (n = 10)
~Supplement appearing similar to Herbal formulations
~Each placebo tablet will contain microcrystalline cellulose, dicalcium phosphate, PVPK30, sodium starch glycolate, magnesium stearate, OpaDry orange coating.
~Dose: subjects in this group will take 4 placebo tablets per day"
15922552|NCT03477825|Dietary Supplement|Rubia Cordifolia|"Group B: R. cordifolia group (n = 10)
~2,000 mg R. cordifolia per day - supplied by Banyan Botanicals and following standard supplementation doses on commercially available supplement (https://www.banyanbotanicals.com/manjistha-tablets/)
~Each tablet contains 500 mg of R. cordifolia per tablet."
15922553|NCT03477825|Dietary Supplement|Triphala|"Group C: Triphala group (n= 10)
~Tablets of Triphala will be supplied from Banyan Botanicals (https://www.banyanbotanicals.com/triphala-tablets-11/)
~Each tablet contains mix Emblica officinalis, Terminalia bellerica, and Terminalia chebula
~Dose: subjects will take 4 tablets per day, with a total dose of 2,000 mg of total herb."
15922554|NCT03477812|Device|Polysomnography (Full sleep registration)|For the healthy children two nights of polysomnography. For the children with nocturnal enuresis one night of polysomnography.
15922555|NCT03477799|Device|Transcranial direct current stimulation|Transcranial direct current stimulation (tDCS) is a safe method for non-invasively modulating cortical excitability through the use of weak electrical currents (usually of 1-2 mA) circulating between two scalp electrodes (i.e., an anode and a cathode) placed over the target cortical regions. The effects of tDCS on brain activity are polarity-dependent, such that anodal stimulation generally enhances cortical excitability by depolarizing cell membranes and increasing neuronal firing rates, while cathodal stimulation generally results in the opposite effect. Because of its neural effects, tDCS has been increasingly used to gauge the functional relationship between cognitive/behavioural dimensions and putatively relevant neurocircuitry
15922556|NCT03477786|Combination Product|drug adjustment and behavioral modification|anti-hypertension drug prescription by physician and case management by health educator
15922557|NCT03477773|Other|High-intensity exergaming|Perform high-intensity exercise whilst playing a developed exergame. A full warm-up performed prior to the session was performed (~70% HRmax). Periods of exercise were performed at an intensity >85% HRmax for periods of 10, 20 and 30s, interspersed with periods of rest, for a total of 2-3 minutes per session. Heart rate was monitored throughout the intervention.
15922621|NCT03477162|Drug|Metformin|Metformin will be given to patients prior to surgery.
15922559|NCT03477747|Device|Microcurrent|Microcurrent based treatments have been proposed more than 30 years. The manufacturer initially should calibrate the microcurrent devices. There is no physical sensation associated with microcurrent based treatments as the strength of the current is not high enough to stimulate sensory nerve fibres. The application of electric fields and currents similar to those generated within the body can substantially change the cell structure and the metabolic behaviour of cells. For example, the application of microcurrent increases the number of organelles responsible for cellular activities; it increases concentrations of adenosine triphosphate (ATP) and amino acid transport; promotes protein synthesis; fastens regrowth of atrophied soleus muscle and would also activate hormone-sensitive lipase which can increase lipolysis from the internal and external adipose tissue. The microcurrent treatment with training would maximize exercise and recovery outcomes in athletes.
15922560|NCT03477734|Device|CS1 & heart monitor|Daily activities while wearing the investigational device as well as the control device
15922561|NCT03477695|Device|ambulatory use of the Upright device|Patients will wear the UpRight for a period of two month
15922562|NCT03477682|Other|Early ambulation|Patients who are in the experimental arm will have a shorter duration of bedrest restriction following sartorius surgery (1 day) versus the standard group (5 days bedrest).
15922563|NCT03477669|Dietary Supplement|chamomile/probiotic arm|Caregivers will administer 5 drops of the study product once a day with a feeding at mid-day.
15922564|NCT03477669|Dietary Supplement|Placebo of chamomile/probiotic arm|Caregivers will administer 5 drops of the placebo study product once a day with a feeding at mid-day.
15922565|NCT03477656|Procedure|Large volume specific immunoadsorption|1 to 2 sessions of large volume specific immunoadsorption using GLYCOSORB®-ABO column
15922566|NCT03477656|Procedure|Double Filtration Plasmapheresis|1 to 5 sessions of double filtration plasmapheresis
15922567|NCT03477630|Biological|Platelet Rich Plasma|Infiltration PRP 8cc per session, 4 sessions, 1 session every 15 days.
15922568|NCT03477630|Drug|Hyaluronic Acid|Infiltration 6 cc of HA , only once.
15922569|NCT03477617|Other|Intraoperative Hemodynamic Algorithm|Anesthesiologists are instructed to use the study's algorithm to manage intraoperative hypotension in response to the cardiac output monitor values.
15922570|NCT03477617|Combination Product|Usual hemodynamic management|Anesthesiologists are instructed to manage intraoperative hypotension based on their usual clinical care, without information from cardiac output monitor
15922571|NCT03477604|Device|MicroStent and Standard PTA|Self-expanding stent and standard PTA balloon
15922572|NCT03477604|Device|Standard PTA|Standard PTA balloon
15922573|NCT03477591|Other|Evidence-based information|Evidence-based information on PSA testing such as blog posts, plain language evidence summaries and web resource ratings (quality-appraised online resources).
15922574|NCT03477591|Other|Patient Decision Aid|Patient Decision Aid for prostate cancer screening decision
15922575|NCT03477591|Other|Sham information|Educational information not specific to PSA testing or cancer screening
15922576|NCT03477578|Other|freezers|neuropsychological evaluation
15922577|NCT03477578|Other|non freezers|neuropsychological evaluation
15922578|NCT03477565|Device|Kinesio tape lymphatic drainage technique application|Kinesio Tex Tape strips are applied following Dr.Kase draining techinique. The choice of tape's length and strips' number is based on the area of breast edema and/or presence of seroma, which must be completely covered. The patch is cut into fan strips. The major base is positioned near the functioning lymph node stations closest to the edema and/or seroma area. The bases and the tails of the fan must be applied with zero tension, while for the central part is reached 15-25% of tension. The first application takes place on the 1st post-operative day, while the second is performed on the 7th post-operative day. In case the tape is detached from one application to another, it is necessary that the patient resume in the clinic for a new application to ensure continuity of the therapeutic effect; otherwise the patient is eliminated from the study. The experimental group also receives the expected standard treatment, consisting in physiotherapeutic evaluation and counselin.
15922579|NCT03477552|Device|Accuvein V400 device|Sickle cell patients who need a new vein puncture in order to infuse them will benefit of AccuveinV400 device to illuminate their venous network
15922580|NCT03477552|Other|Routine procedure|In the control group, the nurse proceeds as usual to infuse the patient (visual identification in the light of the chamber and palpation)
15922581|NCT03477539|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo ASCT
15922582|NCT03477539|Biological|Daratumumab|Given IV
15922583|NCT03477539|Drug|Lenalidomide|Given PO
15922584|NCT03477526|Procedure|Pulmonary rehabilitation program|3 weeks, ...
15922585|NCT03477513|Radiation|Radation Therapy|Personalized Radiation Therapy
15922586|NCT03477500|Drug|Cyclophosphamide and ATG|Hematopoetic stem cell transplantation
15922587|NCT03477500|Drug|Alemtuzumab|Alemtuzumab (Lemtrada)
15922588|NCT03477487|Biological|XT-150|Human IL-10 variant transgene in a plasmid DNA vector
15922589|NCT03477461|Drug|terlipressin|a continuous infusion of terlipressin (0.4 mg/kg/h) was initiated
15922590|NCT03477448|Drug|Bleomycin|"an antibiotic derived from Streptomyces verticillus, has an antitumor, antibacterial, and antiviral activity that may be related to its ability to bind with DNA, causing bleomycin strand scission and elimination of pyrimidine and purine bases. The bleomycin hydrolase enzyme, which is known to inactivate bleomycin, is normally found in all body tissues but is present in very small amounts in skin .
~Intra-lesional bleomycin injection (IBI) has been used for the treatment of warts."
15922591|NCT03477448|Drug|Purified Protein Derivative|"is an extract of Mycobacterium tuberculosis and is used for testing exposure to tuberculin protein, either from a previous vaccination or from the environment. It contains live, attenuated Mycobacterium bovis.
~Using this protein derivative for immunotherapy of warts is important for two major aspects. First, because the obligatory immunization program in many developing countries - with high prevalence of wart in many of them - includes BCG vaccination. PPD has a high prevalence of immunity in the general population. Second, although immunotherapy is generally an inexpensive method of treatment in wart patients, PPD, among conventionally used antigens, is the cheapest"
15922622|NCT03477149|Device|Easyx|Embolization will be done with Easyx liquid agent.
15922623|NCT03477136|Diagnostic Test|ELISA to evaluate serum and seminal vitamin D level|Serum and semen samples will be collected from all participant males and ELISA method used to evaluate the level of vitamin D in serum and semen
15922592|NCT03477435|Behavioral|Staff training and academic detailing|Both arms will receive training at baseline to help their patients quit smoking. The training will be a mix of content and process education. We will provide brief updates to staff every 6 months throughout the intervention period, which will focus primarily on process education. We will monitor which staff attend and reach out separately to staff who did not. During the month after implementation of the clinical reminders, two study investigators will make a brief outreach visit to each staff member. We will follow a script, using the seven steps recommended by the National Resource Center for Academic Detailing: 1) Introduction; 2) Needs Assessment; 3) Key Messages/Features/Benefits; 4) Understanding Barriers and Enablers; 5) Identifying and Handling Objections; 6) Summary; and 7) Close. The key message (Step 3) will include demonstration of the clinical reminder, review of the evidence for telephone counseling and text messaging and how to refer patients.
15922593|NCT03477422|Drug|CSE-1034 (Ceftriaxone + Sulbactam + EDTA)|CSE-1034 (Ceftriaxone + Sulbactam + EDTA) was Experimental in this study and is a combination of Ceftriaxone 1000mg, Sulbactam 500mg and EDTA 37mg available as dry powder for reconstitution. Patients were given either CSE-1034 or placebo through IV route four times daily, strictly adhering to the time interval. Time of the first dose (Drug) was considered 0th hr, the second dose (Placebo) was given at 8th hour from first dose, third dose (Drug) at 12th hour from first dose and the fourth dose (Placebo) at 16th hour from first dose. The infusion was initiated within ± 30 min of schedule time.
15922594|NCT03477422|Drug|Meropenem|Meropenem was the Comparator in the study. It was also available as dry powder for reconstitution and contained active ingredient Meropenem 1000mg.Patients were given either Meropenem or placebo through IV route four times daily, strictly adhering to the time interval. Time of the first dose (Drug) was considered 0th hr, the second dose (Drug) was given at 8th hour from first dose, third dose (Placebo) at 12th hour from first dose and the fourth dose (Drug) at 16th hour from first dose. The infusion was initiated within ± 30 min of schedule time.
15922595|NCT03477409|Other|plasticizers|The purpose of this biomonitoring study consists to evaluate the exposure of newborns and premature babies hospitalized in NICU to these plasticizers (DEHT and TOTM), by qualitative and quantitative measurement of their urinary metabolites
15922596|NCT03477396|Drug|Aromatase Inhibitor|Aromatase inhibitor per treating investigator's discretion
15922597|NCT03477396|Other|Laboratory Biomarker Analysis|Correlative studies
15922598|NCT03477396|Other|Pharmacokinetic Study|Correlative studies
15922599|NCT03477396|Other|Questionnaire Administration|Ancillary studies
15922600|NCT03477396|Drug|Ribociclib|Given PO
15922602|NCT03477357|Device|Geratherm non Contact thermometer|Temperature taken from subject using non-contact device as per manufacturers instructions
15922603|NCT03477344|Drug|Dexmedetomidine|Intravenous infusion with electric syringe of Dexmedetomidine 0,4ug/ml. Rate 0,1ug/kg/h to 1,4ug/kg/h. Nightly infusion from 20:00 to 08:00. The drug is titrated to achieve RASS between -1 and 1. Modification of infusion rate by 0,1ug/kg/h is recommended with stabilization phase of 1 hour before another rate adjustment.
15922604|NCT03477344|Drug|Sodium chloride 0.9%|Intravenous infusion with electric syringe of normal saline. Rate modifications follow the same rules as in experimental group.
15922605|NCT03477305|Behavioral|Blackberry Consumption|Measures of biomedical and behavioral changes resulting from the consumption of blackberries.
15922606|NCT03477292|Drug|Duration of antibiotic|Duration of antibiotic for treatment of VAP
15922607|NCT03477279|Behavioral|Enhanced Couple HIV Testing and Counseling|"Participants are provided study-specific partner referral cards and encouraged to bring male partners to antenatal care for a male engagement intervention. Those who do not present on their own are then traced.
~Couples will receive three enhanced couple counseling sessions that include: pre-test counseling, return of joint results, and post-test counseling. HIV-infected men will be able to initiate cART at the antenatal clinic and the couple will be offered condoms from the HTC counselor. Between sessions, couple members can pick up condoms and cART for one another."
15922608|NCT03477266|Drug|Mosapride|Intake mouthly dissolving mosapride tablets in immediate post cesarean section
15922609|NCT03477266|Drug|Placebo Oral Tablet|Dummy identical tablets to mouthly dissolving mosapride tablets
15922610|NCT03477253|Procedure|Laparoscopic cholecystectomy|The use of laparoscopic cholecystectomy in management of acute calculous cholecysitits
15922611|NCT03477227|Device|Short stocking|Patients in the experimental group will be asked to wear new type of compression stockings for four weeks post-operatively
15922612|NCT03477227|Device|Usual stocking|Patients in the control group will be asked to wear usual type of compression 2 class stockings for four weeks post-operatively
15922613|NCT03477214|Diagnostic Test|Biomechanical and electromyography mapping|The vaginal tactile imaging probe will acquire biomechanical and electromyography high definition measurements for anterior and posterior compartments along entire vagina.
15922614|NCT03477201|Procedure|Laparoscopic robotic DaVinci assisted inguinal hernia repair|Laparoscopic inguinal hernia repair using a robotic assisted laparoscopic procedure.
15922615|NCT03477201|Procedure|Standard laparoscopic inguinal hernia repair|Laparoscopic inguinal hernia repair, an accepted safe method of repairing inguinal hernia.
15922616|NCT03477188|Behavioral|Somatosensorial and Vestibular Exercises|In the experimental group, the subjects who were taken to the somatosensorial and vestibular exercises program after pre- treatment evaluations. The subjects in this group were given classical physiotherapy and somatosensorial combined with vestibular exercise performed 5-7 days a week, 1 set of 10 times with physiotherapist control. In the content of the training, in addition to the general physiotherapy program applied for Brunnstrom and Bobath exercises and spasticity inhibition according to in-bed mobility, Flask and spasticity conditions in the experimental group, a mutual study program was prepared with Cawthorne-Cooksey and Frenkel exercises in the bed, then balance and walking will be performed with the exercises
15922617|NCT03477188|Behavioral|Conventional Group|In the control group, The subjects who were taken into the study were taken to the classical physiotherapy based on Bobath and Brunnstrom will be applied to increase the mobilization and spasticity up to the discharge stage known as 5-7 days a week
15922618|NCT03477175|Drug|E7080|Oral Administration.
15922619|NCT03477175|Drug|Comparator Drug|Per parent study.
15922620|NCT03477175|Drug|Comparator Drug: Sorafenib|Per parent study.
15922628|NCT03477110|Procedure|Tumor Treating Fields Therapy|Undergo tumor treatment fields therapy using NovoTTF-200A device
15922629|NCT03477097|Other|Nutrition, exercise and social network intervention|
15922630|NCT03477084|Biological|ESBL-producing enterobacteriaceae carriage|Carriage of ESBL-producing Escherichia coli or Klebsiella pneumoniae
15922631|NCT03477071|Procedure|Angioplasty for Transplant Renal Artery Stenosis (TRAS)|The angioplasty is an endovascular treatment for artery stenosis, which could be associated with stenting or not.
15922632|NCT03477058|Other|WO 3308 cosmetic product for topical use|Application on the entire body at least once a day over two weeks
15922633|NCT03477045|Dietary Supplement|Single dose fish oil|Fish oil consumed within a single high fat test meal
15922634|NCT03477045|Dietary Supplement|Repeated dose fish oil|Fish oil consumed daily for 8 weeks
15922635|NCT03477045|Dietary Supplement|single dose Camelina seed oil|camelina seed oil consumed within a single high fat test meal
15922636|NCT03477045|Dietary Supplement|repeated dose camelina seed oil|camelina seed oil consumed daily for 8 weeks
15922637|NCT03477032|Biological|Faecal Microbiota Transplantation|Faeces acquired from a healthy donor
15922638|NCT03477019|Drug|SonoVue|"consists of microbubbles containing sulfur hexafluoride stabilized by phospholipids.
~Bolus doses à 1,0ml administered every 3.5 minutes , repeated 9 times. Total duration of treatment: 31,5 minutes. This treatment will be repeated maximally 4 times at 2 or 3 week intervals, depending on the patient's diagonse and treatment protocol."
15922639|NCT03477019|Procedure|Focused Ultrasound|ultrasound pulses will be generated by a clinically approved ultrasound skanner and probe.
15922640|NCT03477006|Biological|Whole blood|Low titer, group O, leukocyte reduced, platelet replete, cold stored whole blood
15922641|NCT03476993|Biological|BCD-085|All patients will receive BCD-085 (subcutaneous injections) once a week during the period of induction of remission, then once every 2 weeks during the period of remission maintenance and then once every 4 weeks during the period of accumulation of treatment effect. All patients will receive ursodeoxycholic acid (UDCA) in standard dose 13-15 mg/kg/day.
15922642|NCT03476980|Procedure|Randomized to Umbilical Cord Milking at birth|The subjects in this group were randomized to UCM X4 at birth. This procedure infuses a placental transfusion of blood by milking the umbilical cord towards the infant at birth.
15922643|NCT03476980|Procedure|Randomized to Delayed Cord Clamping at birth|The subjects in this group were randomized to DCC at birth. At delivery, the obstetrician was instructed to delay clamping of the umbilical cord for 60 seconds.
15922644|NCT03476967|Procedure|Panretinal photocoagulation|In cases of proliferative diabetic retinopathy (PDR), panretinal photocoagulation (PRP) is the first-line treatment. Although PRP reduces the risk of severe vision loss, it has been shown that laser energy can cause destruction to all layers of retina including the ganglion cells and the retinal nerve fiber layer (RNFL), and therefore generate visual field defects similar to that observed in glaucomatous damage. In such cases, visual field testing can be less helpful to evaluate glaucomatous damage in PDR patients treated with PRP.
15922645|NCT03476954|Other|Respiratory Impedance (RI)|A non-invasive respiratory device is employed to generate resistance during the inspiratory phase of respiration.
15922646|NCT03476941|Drug|Gentamicin Sulfate Inj 20mg/2ml vial for injection|Irrigate surgical drain with total amount of 5 mg in 10 ml volume twice/day for 7 days or until drain removal if less than 7 days of therapy.
15922647|NCT03476941|Drug|Clindamycin phosphate 6 mg/1ml for injection|Irrigate surgical drain with total amount of 12 mg in 10 ml volume once daily for 7 days or until drain removal if less than 7 days of therapy.
15922648|NCT03476941|Other|Placebo|The placebo group will receive drain irrigation twice/day
15922649|NCT03476928|Drug|Vilaprisan (BAY1002670)|2mg, once daily, oral
15922650|NCT03476915|Other|ultrasound examination of the hip joint|US examination by US machine , Midray model DP-2200 made in China , with a high frequency (5-10 MHZ) linear transducer using the previously described Graf method for assessment of both hip joints.
15922651|NCT03476902|Behavioral|Therapist assisted mobile intervention|Individuals will receive 4 introductory sessions with a therapist followed by weekly phone calls. Participants will utilize nOCD application to assist with treatment protocol adherence.
15922652|NCT03476889|Other|Infant formula|Infants are randomized to one of two infant formulas from <14 days of age to 17 weeks of age.
15922653|NCT03476876|Device|Dermacell|Subject will receive treatment for deep diabetic foot ulcer using Dermacell acellular matrix. Subject will be followed for 16 weeks post treatment.
15922654|NCT03476876|Device|Integra|Subject will receive treatment for deep diabetic foot ulcer using Integra acellular matrix. Subject will be followed for 16 weeks post treatment.
15922655|NCT03476863|Procedure|Alveolar Recruitment Maneuver|Patients in the Experimental Group will be submitted to ARM, immediately after abdominal desinflation of the pneumoperitoneum (PNP). The ARM will be performed with PEEP of 15 cmH2O for thirty seconds, 20 cmH2O for thirty seconds, 25 cmH2O for thirty seconds, 30 cmH2O for one minute and a inspiratory plateau pressure of 15 cmH2O above PEEP, totaling two minutes and thirty seconds.The data of the TIE will be continuously recorded and the hemodynamic and respiratory function variables such as heart rate (HR), respiratory rate (RF), mean arterial pressure (MAP), peripheral oxygen saturation (SpO2) and final gas expiratory pressure carbon dioxide (PETCO2) will be recorded in several moments: immediately after the monitoring, and the patient is still on spontaneous ventilation, 5min after orotracheal intubation, after the installation of the pneumoperitoneum, before and after the execution of the MRA and in the Post-OP, in the first 24h, along with new lung function tests.
15922656|NCT03476863|Procedure|Conventional mechanical ventilation|Immediately after intubation, patients will undergo mechanical ventilation with the ventilator (Dixtal DX 5020) in volume controlled mode with an ideal tidal volume of 7 ml / kg body weight, a set frequency to maintain a carbon dioxide of 35-42 mmHg, and an inspiratory / expiratory ratio of 1: 2. The inspiratory oxygen fraction (FIO2) will be 0.5.
15922657|NCT03476850|Procedure|QL Block|Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance QL blocks. QL block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc.
15922658|NCT03476850|Procedure|TAP Block|Blocks will be performed under the supervision of a regional anesthesia attending experienced in the performance TAP blocks. TAP block will be performed using ropivacaine 0.375% 20ml each side for a total volume of 40cc.
15949895|NCT03265132|Drug|Placebo|sub cutaneous injection
15922659|NCT03476837|Behavioral|Treatment|The CHWs will go to the homes of the WCGs who enroll in the study and will use a culturally-adapted motivational interviewing protocol, educational messages pilot tested during the formative research phase, and biofeedback based on the child's saliva sample and WCG's carbon monoxide. Saliva samples will be collect from one child in the home at baseline and final. Baseline saliva data and carbon monoxide monitoring will be used to develop feedback that aims to motivate WCGs to implement and sustain comprehensive smoke free policies. The intervention will last 6 months. We will measure changes in primary and secondary outcomes at multiple assessment points.
15922660|NCT03476837|Behavioral|Control|Following baseline assessment, at 1, 3, and 6 months, WCGs in the control group will educational materials in the mail. Final follow-up assessments will occur at 12 months.
15922661|NCT03476811|Drug|0.25% Marcaine at 2ml/hr and pain medications|Subcutaneous pain control with OnQ Subcutaneous Drug pump
15922662|NCT03476811|Device|Placement of OnQ Drug pump|Subcutaneous placement of OnQ drug pump with normal saline infusion
15922663|NCT03476798|Drug|Rucaparib|Rucaparib 600mg PO BID daily
15922664|NCT03476798|Drug|Bevacizumab|Bevacizumab 15mg/kg IV on day 1 of each cycle
15922665|NCT03476785|Behavioral|High intensity exercise|Subjects will perform high intensity aerobic exercise in addition to moderate intensity sessions 4-5 times per week.
15922666|NCT03476785|Behavioral|Yoga|Subjects will perform strength and flexibility exercises.
15922667|NCT03476772|Drug|Nalbuphine|Children will be randomly assigned into 2 groups of 30 patients each. They will receive caudal anesthesia using bupivacaine 0.25% 1ml/kg plus 2 ml normal saline in the control group, bupivacaine 0.25% 1ml/kg plus nalbuphine 0.1 mg/kg in 2 ml solution in the nalbuphine group.
15922668|NCT03476759|Procedure|Tubal adhesiolysis|125 patients will undergo tubal adhesiolysis or tuboplasty
15922669|NCT03476759|Drug|IVF/ICSI|125 patients will undergo IVF-ICSI procedures.
15922670|NCT03476746|Drug|LEO 90100 foam|A foam formulation of the active comparator Dovobet® ointment
15922671|NCT03476746|Drug|Dovobet® ointment|Ointment formulation containing same active ingredients as LEO 90100 foam
15922672|NCT03476733|Other|Detection of drug related problem in inpatient|Detection of drug related problem in inpatient
15922673|NCT03476720|Device|Pad positioning according to a manufacturer's diagram|Placement of defibrillation pads according to the diagram
15922674|NCT03476707|Other|Anemia|Hematocrit less than 0.39
15922675|NCT03476694|Procedure|ultra sound guided supraclavicular brachial plexus block|ultra sound guided supraclavicular brachial plexus block , comparing the volume of 0.75 % ropivacine in sucessful block and hemidiaphragmatic motilty.
15922677|NCT03476668|Other|MIRT|4-week multidisciplinary intensive rehabilitation treatment
15922678|NCT03476655|Drug|Ibrutinib|No study treatment will be administered as a part of this study. Participants in this observational study with confirmed diagnosis of CLL and MCL receiving ibrutinib treatment before 30 April 2018 in routine clinical practice settings will be observed.
15922679|NCT03476642|Drug|Ropivacaine|injection of 20mL of 0.5% Ropivacaine at the left or right T5 transverse process
15922680|NCT03476642|Drug|Epinephrine|injection of 20mL epinephrine in combination with ropivacaine at the left or right T5 transverse process
15922681|NCT03476629|Other|Physical activity|Effects of different physical activity programs
15922682|NCT03476616|Drug|Eplerenone (-based therapy) arm|At randomization, pts meeting inclusion/exclusion criteria will be randomized (1:1) to either eplerenone (E) 25mg bd or valsartan (V) 160mg od for 8 wks. At 8, 16 and 24 wks, pts at both arms will be evaluated with ABPM primary, as well as home and office BP measurements. At wk 8, pts with controlled hypertension (mean ABPM <130/80mmHg), will continue in monotherapy with eplerenone or valsartan and pts with uncontrolled hypertension (mean ABPM ≥130/80mmHg) will continue with the addition of amlodipine (C) 10mg od. At wk 16, pts achieving BP control will continue in either monotherapy (E), (V) or dual therapy (E+C), (V+C). However, in pts not achieving ABPM target, a third drug, will be added [indapamide (D) 1.25 mg od]. All groups at both arms will be evaluated at 24 wks by ABPM.
15922683|NCT03476616|Drug|Valsartan (-based therapy) arm|At randomization, pts meeting inclusion/exclusion criteria will be randomized (1:1) to either eplerenone (E) 25mg bd or valsartan (V) 160mg od for 8 wks. At 8, 16 and 24 wks, pts at both arms will be evaluated with ABPM primary, as well as home and office BP measurements. At wk 8, pts with controlled hypertension (mean ABPM <130/80mmHg), will continue in monotherapy with eplerenone or valsartan and pts with uncontrolled hypertension (mean ABPM ≥130/80mmHg) will continue with the addition of amlodipine (C) 10mg od. At wk 16, pts achieving BP control will continue in either monotherapy (E), (V) or dual therapy (E+C), (V+C). However, in pts not achieving ABPM target, a third drug, will be added [indapamide (D) 1.25 mg od]. All groups at both arms will be evaluated at 24 wks by ABPM.
15922684|NCT03476603|Drug|Irbesartan|Patients are tested for their normal prescription irbesartan medication
15922685|NCT03476590|Procedure|new model of ambulatory care with use of of non-invasive vital signs assessment and telemedicine|"The report of symptoms and physical examination will be obligatory performed by the ACP nurse. Self-condition and quality of life assessment at every visit will be based on EQ-5D questionnaire and VAS 10-points scale Hemodynamic assessment - the ACP nurse will perform impedance cardiography (cardiomonitor) and bioimpedance (scale). The parameters measured by ICG and bioimpedance will be assessed with respect to individually defined target values for: heart rate (HR), systolic and diastolic blood pressure (SBP and DBP), thoracic fluid content (TFC) and its change (delta TFC), change of body mass and total body water (delta TBW).
~Supervising physician will confront ICG/bioimpedance results with the patient's clinical data and give final remote recommendations."
15922686|NCT03476577|Drug|Ibuprofen|Patients are tested for their normal prescription ibuprofen medication
15922687|NCT03476564|Drug|pentoxifylline|will be given 2 cycles before starting ICSI cycle and the medication will be continued until the beta-hCG becomes positive or the cycle is cancelled
15922688|NCT03476564|Drug|Vit E|will be given 2 cycles before starting ICSI cycle and the medication will be continued until the beta-hCG becomes positive or the cycle is cancelled
15922689|NCT03476551|Drug|Hydrochlorothiazide|Patients are tested for their normal prescription hydrochlorothiazide medication
15922690|NCT03476538|Drug|Gabapentin|Patients are tested for their normal prescription gabapentin medication
15922691|NCT03476525|Drug|Fluoxetine|Patients are tested for their normal prescription fluoxetine medication
15922692|NCT03476512|Other|Adherence Education|Patients were given adherence education to resolve the identified deficits
15922693|NCT03476499|Device|Near Infrared Imaging (NIR) device|Handheld near infrared multispectral imaging device with custom software.
15922694|NCT03476486|Procedure|Thread carpal tunnel release|Ultrasound-guided percutaneous minimally invasive thread carpal tunnel release using a looped thread technique
15922695|NCT03476460|Drug|Oral sodium chloride|Patients will receive capsules of sodium chloride and free water ingestion (for each capsule of sodium chloride, with 250 ml of water, assuring a minimum ingestion of 750 ml of water) in the 48 hours prior contrast injection. Patients will take capsules of sodium chloride at a dose of 100 mg/kg during 48 hours previous the injection of contrast (48, 40, 32, 24, 16, and 8 hours), at the moment of contrast injection and 12 hours after the injection of contrast.
15922696|NCT03476460|Drug|Intravenous sodium chloride|Patients will receive at hospital 3 ml/Kg of sodium chloride 0.9%, one hour previous contrast injection and 2 ml/kg during the 4 hours after contrast injection.
15922697|NCT03476447|Other|B. infantis EVC001|A once-daily oral feeding of B. infantis EVC001 will be mixed with breast milk and provided to infants for 28 consecutive days.
15922698|NCT03476447|Other|Lactose|A once-daily oral feeding of a lactose placebo will be mixed with breast milk and provided to infants for 28 consecutive days.
15922699|NCT03476434|Device|chromoendoscopy with indigo carmine|the lumen of the colon is sprayed in a segmental fashion using 0.4% indigo carmine delivered via a specially designed dye spray catheter (Olympus PW-5V1) or via the accessory channel with a 50cc syringe filled with indigo carmine and air.
15922700|NCT03476421|Procedure|Hepatic resection|Surgery of the liver; removal of a part of the liver
15922701|NCT03476408|Other|Correlation / Observational|correlation between Plantar Sensation, Balance, Risk of Falling and Gait in Patients With Schizophrenia
15922702|NCT03476395|Other|shoulder range of motion in IR/ER, strength of the IR/ER muscles and Scapular Dyskinesis Test. Core endurance test.|Passive shoulder range of motion using a digital application Clinometer. Isometric strength of the shoulder IR/ER using a HHD measured. Scapular Dyskinesis Test uses a visual scoring system. Core Endurance is teste by measuring the time (s).
15922703|NCT03476382|Device|Ultrasound Bone Growth Stimulator|Active device emits ultrasound signals.
15922704|NCT03476369|Drug|Fentanyl|Premedicated with Fentanyl (at least 25mcg by IV)
15922705|NCT03476369|Drug|Ticagrelor 90Mg Tablet|Ticagrelor administered crushed vs non-crushed
15922706|NCT03476356|Drug|oral clomiphene citrate|oral clomiphene citrate 50 mg tablet, two times per day will be received from the third day of the cycle until the seventh day of the cycle.
15922707|NCT03476356|Drug|oral carnitine supplementation|oral carnitine supplementation 1g tablet, three times per day will be received from the third day of the cycle until the day of the pregnancy test.
15922708|NCT03476343|Device|GE OPTIMA MR430s with HDx/GE Electronics|MRI scan
15922710|NCT03476317|Drug|Vancomycin|Oral suspension 4 times daily (Day 1-14)
15922711|NCT03476317|Drug|Neomycin|Oral three times daily (Days 1-3)
15922712|NCT03476317|Drug|Ciprofloxacin|Oral twice daily (Days 4-14)
15922713|NCT03476317|Drug|Polyethylene Glycol 3350|Dissolved in Gatorade on day 2
15922714|NCT03476317|Drug|Fluconazole|Orally once daily (Day 1-14)
15922715|NCT03476304|Device|Endocrown restoration|The endodontically treated tooth will be impressed, and an endocrown restoration will be manufactured with resin composite in a cast and cemented with self adhesive cement
15922716|NCT03476304|Device|Post retained composite restoration|The endodontically treated tooth will receive a fiber post cemented with self adhesive cement and after this, the tooth will be impressed and a semi direct composite restoration will be cemented with self adhesive cement.
15922717|NCT03476304|Device|Post retained ceramic restoration|The endodontically treated tooth will receive a fiber post cemented with self adhesive cement and after this, the tooth will be impressed and a ceramic restoration will be cemented with self adhesive cement.
15922718|NCT03476278|Other|Questionnaire|Postoperative questionnaire, and records of complications in the peri-operative period
15922719|NCT03476265|Device|Electrical Stimulation of the Lower Esophageal Sphincter|Laparoscopic implantation of an electrical stimulation device to perform an electrical sphincter augmentation for the treatment of GERD.
15922720|NCT03476252|Diagnostic Test|pentraxin 3|serum pentraxin 3 level will be assessed using ELISA kits
15922721|NCT03476239|Drug|Blinatumomab|"Blinatumomab will be supplied as single-use glass injection vials as a sterile, preservative-free, white to off-white, lyophilized powder for reconstitution and administration by continuous intravenous infusion (CIVI).
~A single cycle of blinatumomab treatment is 6 weeks in duration, which includes 4 weeks of blinatumomab CIVI followed by a 2 week treatment-free interval. The treatment-free interval may be prolonged by up to 7 days, if deemed necessary by the investigator."
15922722|NCT03476239|Drug|Dexamthasone|Premedication with dexamethasone was intended to prevent cytokine release syndrome (CRS) events associated with blinatumomab treatment. Treatment could start pre-study. Dexamethasone 20 mg IV was administered within 3 hours before start of blinatumomab in each treatment cycle, and within 3 hours before dose step increase.
15922723|NCT03476226|Other|Cognitive Dysfunction Coping Strategy Teaching Sheet|Demographic sheet, Fact-Cog3, and teaching tool at baseline then week 4 and 8 Fact Cog3 and reinforcement of tool, at week 16 evaluation and Fact-Cog3
15922724|NCT03476213|Procedure|Group TCI|Induction and anesthesia will be done by using Gepth model for sufentanil and Schnider effect model for propofol. Anesthetics will be aplicated using infusion pump Agilia (Fresenius Kabi). Another titration will be according to target value of entropy between 40 and 60 and surgical pleth index below 35.
15922725|NCT03476213|Procedure|Group TIVA|Induction of anesthesia will be done by titrating of propofol to the dose of 1.2 mg/kg and sufentanil 5-10 ug according to body weight, maintaining of anesthesia using continuous infusion of propofol 5 mg/ kg/hour and sufentanil 35 ug/hour to reach the target value of entropy between 40 and 60 and surgical pleth index below 35.
15922751|NCT03475953|Drug|Phase 2 : Regorafenib|Phase 2 : Regorafenib - All patients will be treated at the RP2D of regorafenib defined in the preliminary phase 1 trial with the same schedule as in the phase I.
15922726|NCT03476200|Behavioral|Cognitive Behavioral Therapy|The intervention consist of 14 weekly group meetings lasting 1.5 or 2 h. Groups are made up of 10 patients. Each group session follow a structured format and consisted of the following elements: introduction to the session, discussion of homework, group discussion and the development of new coping skills. The sessions deal with the following: concept of stress, cognitive restructuring, alternative thought control strategies, relaxation techniques, training in social skills, training in social skills and humour and optimism as coping strategies.
15922727|NCT03476187|Device|µCor|Monitor with µCor
15922728|NCT03476174|Drug|Pembrolizumab|Subjects will receive 200 mg pembrolizumab every 3 weeks for two cycles. Cycle length is 21 days (i.e., 3 weeks). On the last day of Cycle 2 (+/- 3 days), disease status will be assessed via imaging.
15922729|NCT03476174|Drug|Interleukin-2|Following the pembrolizumab treatment, HD IL-2 treatment will commence. After completing the 2 cycles of pembrolizumab, High Dose Interleukin-2 (HD IL-2) will be administered. This will require a hospital stay of at least 5 days for each treatment cycle. Established guidelines will be followed for safely administering HD-IL-2 and managing toxicities from this treatment. Two treatment cycles will be administered, Cycle 2 being separated from Cycle 1 by approximately 9 days after completion (assuming subject has recovered from Cycle 1 adequately to proceed with Cycle 2). Four weeks after completion of the 2 cycles (called a course of HD IL-2 therapy), disease status will be monitored via CT of the chest and abdomen/pelvis using revised RECIST guidelines
15922730|NCT03476161|Device|3M Unitek Victory Series™ Superior Fit Buccal Tube with APC™ Flash-Free Adhesive. 4069-6103 / 4069-6114 / 4069-6203 / 4069-6214|One type of first permanent molar buccal tube used for fixed orthodontic treatment. One types of adhesive, with same buccal tube base.
15922731|NCT03476161|Device|3M Unitek Victory Series™ Superior Fit Buccal Tube with APC™ II Adhesive. 3069-6103 / 3069-6114 / 3069-6203 / 3069-6214|One type of first permanent molar buccal tube used for fixed orthodontic treatment. One types of adhesive, with same buccal tube base.
15922732|NCT03476148|Device|Home Rehabilitation using Interactive device|Rehabilitation is performed using interactive motion tracking augmented reality device. 6 exercises are included in one-day rehabilitation program. Each exercise is recorded in aspect of compliance, completion.
15922733|NCT03476148|Other|Inpatient Rehabilitation|Patients are given the exercises in the setting of inpatient rehabilitation
15922734|NCT03476135|Biological|MenACYW conjugate vaccine|Meningococcal polysaccharide (serogroups A, C, Y, and W) tetanus toxoid conjugate vaccine 0.5 mL, intramuscular
15922735|NCT03476109|Drug|Randomisation to omalizumab|The only intervention will be that allocation of patients to omalizumab or mepolizumab (to both of which patients will be eligible) will be randomized, to avoid that the initial decision is biased by confounding factors that are likely, but unproven, to affect the treatment response. Then, in case of non-response, patients will be switched to the other drug, as routine clinical practice would indicate.
15922736|NCT03476109|Drug|Randomisation to mepolizumab|The only intervention will be that allocation of patients to omalizumab or mepolizumab (to both of which patients will be eligible) will be randomized, to avoid that the initial decision is biased by confounding factors that are likely, but unproven, to affect the treatment response. Then, in case of non-response, patients will be switched to the other drug, as routine clinical practice would indicate.
15922737|NCT03476083|Drug|Tenofovir Disoproxil Fumarate (TDF) 300 mg oral daily.|All mothers will receive TDF therapy. However, group A will initiate TDF at the gestational week of 14-16, while group B will initiate TDF at the gestational week of 28. All infants will receive a series of three hepatitis B vaccines (at birth, age of weeks 4 and 24). In addition, the infants in the group B will receive HBIg injection at birth.
15922738|NCT03476057|Diagnostic Test|Device： NGS sequencing cfDNA|NGS sequencing cfDNA and Tumor Burden
15922739|NCT03476044|Drug|Placebo|40 patients will receive starch capsules orally with sips of water 2 hours before induction of anesthesia
15922740|NCT03476044|Drug|Selenium|40 patients will receive Selenium (selenium NATURE'S BOUNTY, INC. Bohemia) 200 mcg orally with sips of water 2 hours before induction of general anesthesia
15922741|NCT03476031|Diagnostic Test|renal biopsy|needle biopsy will be taken from the kidney tissue then, diagnosed
15922742|NCT03476018|Drug|Z-100|Twice a week until 29 days after completion of chemoradiotherapy, then once every 14 days
15922743|NCT03476018|Drug|Placebos|Twice a week until 29 days after completion of chemoradiotherapy, then once every 14 days
15922744|NCT03476005|Behavioral|proficiency based progression training|proficiency based progression training supported by technology enhanced learning
15922745|NCT03475992|Device|Low-power microwave breast imaging system|Investigate the capacity of microwave imaging to detect and characterise diagnosed palpable breast lump
15922746|NCT03475966|Other|Exercise|A kinesiologist will provide each patient wih an individualized home-based exercise program including aerobic, resistance and stretching exercises. Patients will also exercise at our clinic once per week under the supervision of the kinesiologist (prehabilitation arm only)
15922747|NCT03475966|Other|Nutrition|Patients will be asked to fill in a 3-day food diary. A registered dietitian (RD) will review this diary, provide a full nutritional assessment, and ensure patients are following a high-protein diet (1.5 g of protein/kg/day). A whey-protein supplement may be provided to patients, should they require it. The RD will also ensure adequate calorie consumption for weight maintenance and will provided advice to help ease any GI issues the patients may be experiencing.
15922748|NCT03475966|Behavioral|Relaxation techniques|Patients will see a psychologist who will provide relaxation techniques (eg. imagery, visualization, deep breathing exercises) to help patients manage anxiety prior to surgery.
15922749|NCT03475953|Drug|Phase 1 : Regorafenib|A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.). Patients will be allocated 3 dose levels of Regorafenib following a 3 + 3 design.
15922750|NCT03475953|Drug|Phase 1 : Avelumab|A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.). Avelumab will be administered on cycle 1 Day 15 as a 1-hour intravenous (IV) infusion (10mg/kg), repeated every two weeks thereafter (ie. Day 1 and Day 15 of each subsequent cycle, as a 1-hour intravenous infusion).
15922798|NCT03475602|Diagnostic Test|PLA2R|Determination of serum concentration of anti PLA2R antibody
15922752|NCT03475953|Drug|Phase 2 : Avelumab|Phase 2 : Avelumab - All patients will be treated with avelumab with the same schedule as in the phase 1 trial.
15922753|NCT03475953|Drug|Phase 2: low-dose Regorafenib|Phase 2 : Regorafenib - All patients will be treated at a fixed low-dose of regorafenib of 80 mg/day
15922754|NCT03475927|Other|Concerning and knowledge about radiation hazard questionnaire|Concerning and knowledge about radiation hazard questionnaire to determine the concerning and knowledge of radiation hazard among surgeon and anesthesiologist
15922755|NCT03475901|Other|Virtual Reality App|Virtual reality app produced by KindVR played via a stereoscopic head mounted display (Samsung GearVR) and headphones that the patient will wear over their eyes and ears.
15922756|NCT03475888|Device|Medtronic Reveal LINQ™ Insertable Cardiac Monitor (ICM)|Implantation of Medtronic Reveal LINQ™ ICM
15922757|NCT03475875|Device|senofilcon A TEST Lens|senofilcon A with new UV blocker investigational process
15922758|NCT03475875|Device|senofilcon A CONTROL Lens|senofilcon A with new UV blocker standard process
15922759|NCT03475862|Drug|PTI-821 capsule Manipulated|PTI-821 (oxycodone) 40 mg extended release capsule
15922760|NCT03475862|Drug|PTI-821 Non-manipulated|PTI-821 (oxycodone) 40 mg capsule extended release capsule
15922761|NCT03475862|Drug|OxyContin|Crushed OxyContin (oxycodone) extended-release 40 mg tablet
15922762|NCT03475862|Other|Placebo|Matching placebos for PTI-821 and oxycodone IR
15922763|NCT03475862|Drug|Oxycodone|Crushed oxycodone 40 mg immediate release tablet
15922764|NCT03475836|Dietary Supplement|Mentha piperita|Commercially available essential oil suspended in an off-the-shelf vegetable oil.
15922765|NCT03475836|Dietary Supplement|Placebo|Inert placebo control in the form of vegetable oil. This matches the vegetable oil in the active intervention condition.
15922766|NCT03475823|Dietary Supplement|Sideritis Scardica|Sideritis Scardica is a popular, naturally un-caffeinated Eastern European tea extract derived from the ironwort plant
15922767|NCT03475823|Dietary Supplement|Ginkgo biloba|Ginkgo biloba is an extract from the ginkgo tree comprising ginkgolides and bilobalide. In this trial Ginkgo acted as an active control.
15922768|NCT03475823|Dietary Supplement|Placebo control|An inert encapsulated powder provided by Finzelberg.
15922769|NCT03475810|Device|Virtual Reality|Patients will wear virtual reality glasses and start watching 3 D video after confirmation of adequate motor and sensorial block.
15922770|NCT03475810|Drug|Midazolam|1-2 mg midazolam will be administered before spinal punction performed.
15922771|NCT03475797|Device|Occipital nerve stimulation|Occipital nerve stimulation with percutaneous or surgical lead
15922772|NCT03475797|Other|Optimal Medical Management|Optimal Medical Management according to what is done in routine clinical practice : drug, psychobehavioral approach, acupuncture, sophrology, etc.
15922773|NCT03475784|Drug|Restrictive fluid therapy|This group will receive intraoperative crystalloids at rate of 10 mL/Kg/hour followed by postoperative crystalloids at rate of 2 mL/Kg/hour.
15922774|NCT03475784|Drug|Liberal fluid therapy|This group will receive crystalloid preload of 5 mL/Kg, then will receive intraoperative crystalloids at rate of 10 mL/Kg/hour followed by postoperative crystalloids at rate of 6 mL/Kg/hour.
15922775|NCT03475758|Drug|Goserelin|adding goserelin with chemotherapy
15922776|NCT03475732|Drug|XueBiJing injection|100mL XueBiJing injection (dissolved with 100 mL of 0.9% normal saline),intravenous infusion for 1.25 h, q12h for 5 days
15922777|NCT03475719|Drug|HUG186-B and HUG186-D|Bazedoxifene acetate 22.6mg, Cholecalciferol 8.0mg(=800IU)
15922778|NCT03475719|Drug|HUG186|Combination of Bazedoxifene acetate 22.6mg and Cholecalciferol 8.0mg(=800IU)
15922779|NCT03475706|Drug|Solabegron immediate release tablets, low dose|twice daily for 12 weeks.
15922780|NCT03475706|Drug|Solabegron immediate release tablets, high dose|twice daily for 12 weeks.
15922781|NCT03475706|Drug|Matching Placebo|twice daily for 12 weeks.
15922782|NCT03475693|Drug|Magnesium Oxide|400 mg Magnesium oxide tablet given once in the ED, and prescribed to take BID for 5 days total after discharge
15922783|NCT03475693|Drug|Acetaminophen|500 mg tablets given once in the ED, and prescribed to take BID for 5 days total after discharge.
15922784|NCT03475693|Drug|Zofran ODT 4 MG Disintegrating Oral Tablet|Given once in the Emergency department
15922785|NCT03475680|Drug|Sennosides colonic preparation|"Mechanical bowel preparation :
~Sennosides colonic preparation (X-PREP)
~1 per day, on day -2 and day -1"
15922786|NCT03475680|Drug|Oral Gentamycin|Gentamycin 80 mg, 4 per day, on day -2 and day -1; Liquid forms in individual vials
15922787|NCT03475680|Drug|Oral Ornidazole|"Oral Ornidazole :
~Ornidazole
~1 g per day (2 tablet per day), on day -2 and day -1; In tablets"
15922788|NCT03475680|Drug|Oral placebo Gentamycin|"Placebo for oral gentamycin :
~Same presentation as oral gentamycin x4 per day on day -2 and day -1"
15922789|NCT03475680|Drug|Oral placebo Ornidazole|"Placebo for oral Ornidazole :
~Same presentation as oral ornidazole
~1g per day (2 tablet per day) on day -2 and day -1"
15922790|NCT03475654|Behavioral|Technology-assisted rehabilitation|The Jintronix software platform, coupled with the Microsoft Kinect for movement capture, contains individualized exercise modules to increase ROM, endurance and strength. Within this PRCT, online monitoring of activity and actigraphy measurements through a wearable device and completion of an online diary will provide enhanced monitoring of home activities.
15922791|NCT03475654|Behavioral|Usual care|The control group will receive treatment as usual, which includes a personalized home exercise program prescribed by a burn therapist, prior to hospital discharge.
15922792|NCT03475641|Drug|Femoral nerve blockade|The femoral nerve blockade with lidocain is combined to the tumescent anesthesia.
15922793|NCT03475641|Procedure|The current standard treatment|Tumescent anesthesia.
15922794|NCT03475628|Drug|Daratumumab|Daratumumab will be given at a dose of 16 mg/kg administered as an IV infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Subjects will receive pre-infusion medications prior to Daratumumab infusion to mitigate potential IRRs and post- infusion medications after Daratumumab infusion for the prevention of delayed IRRs
15922795|NCT03475615|Drug|Oxaliplatin|130mg/m2, d1, q3w
15922796|NCT03475615|Drug|Paclitaxel|40mg/m2 ip，d1、8 ,q3w
15922797|NCT03475615|Drug|S-1 (Tegafur, Gimeracil and Oteracil Porassium Capsules)|40mg/m2 Bid po，d1-14,q3w
15950174|NCT03263026|Other|R-CHOP + placebo|R-CHOP + placebo
15922800|NCT03475589|Drug|apatinib|Patients with advanced (stage IV) gastric cancer, non-small-cell lung cancer (NSCLC), breast cancer or ovarian cancer will be included in this study to receive apatinib treaetment starting from 250 mg Qd and closely monitored for ADRs during apatinib treatment, with dosage adjustment performed as needed to make the treatment tolerable to the patients.
15922801|NCT03475576|Other|Keuzewijzer|"The intervention, offered to the older civilians and their informal care groups will consist of a updated version of the 'Keuzewijzer'. This is a self-management tool which stimulates the communication within the informal care groups to make behaved choices concerning the care for the older civilian, taking into account the standards, values, concerns and needs of every informal caregiver and older civilian. The most important value of this intervention is the approachability and the structured, but adjusted manner of support, focused on the individual context of care with their specific needs.
~The 'Keuzewijzer' is an online tool whereby, in conversation with the informal care group and older civilian, the following aspects will be discussed in the context of the care for the older civilian: 1) analyzing the problem, 2) detection of possibilities or alternatives, 3) clarifying of motives and feelings and 4) weighting between values."
15922802|NCT03475563|Procedure|Coronary angioplasty with stent implantation|Coronary angioplasty with BiOSS LIM C stent implantation
15922803|NCT03475550|Other|Standard of Care|The intervention involves clinician-provided information to patients receiving a new medication as part of their standard medical care. Intervention 1 includes more detailed information compared to Intervention 2.
15922804|NCT03475537|Device|transcranial direct current stimulation|the treatment of transcranial direct current stimulation
15922805|NCT03475524|Drug|MetFORMIN 1000 Mg Oral Tablet|oral tablet 1ooomg systemic metformin will be given to group
15922806|NCT03475524|Drug|Placebos|oral placebos will be given to control beside trichloracetic acid peeling
15922807|NCT03475524|Drug|Trichloroacetic Acid Peeling|Trichloroacetic acid peeling to the three groups
15922808|NCT03475524|Drug|MetFORMIN 500 Mg Oral Tablet|oral tablet 500 mg
15922809|NCT03475485|Device|ID-Capsule- Active|A standard gelatin or HPMC capsule with an embedded ingestible wireless sensor.
15922810|NCT03475485|Device|Wearable Sensor|Subjects will wear an ID-Reader
15922811|NCT03475485|Device|Placebo|A standard gelatin or HPMC capsule without an embedded ingestible wireless sensor.
15922812|NCT03475459|Drug|NPC-15 and/or Placebo|The dosage and regimen of the study drug in each period is the following. Period I : NPC-15 placebo granules 8 g Period II : NPC-15 placebo granules 4 g + NPC-15 granules 0.2% 4 g (melatonin 8 mg) Period III : NPC-15 granules 0.2% 8 g (melatonin 16 mg)
15922813|NCT03475446|Device|real anodal tDCS healthy elderly|A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the real anodal tDCS in the group of healthy elderly.
15922814|NCT03475446|Device|real tACS healthy elderly|A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the real tACS in the group of healthy elderly.
15922815|NCT03475446|Device|sham tES healthy elderly|A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the sham tES in the group of healthy elderly.
15922816|NCT03475446|Device|real anodal tDCS MCI|A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the real anodal tDCS in the MCI group.
15922817|NCT03475446|Device|real tACS MCI|A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the real tACS in the MCI group.
15922818|NCT03475446|Device|sham tES MCI|A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the sham tES in the MCI group.
15922819|NCT03475446|Device|real anodal tDCS AD|A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the real anodal tDCS in the AD group.
15922820|NCT03475446|Device|real tACS AD|A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the real tACS in the AD group.
15922821|NCT03475446|Device|sham tES AD|A neuroConn DC-Stimulator PLUS (neuroCare Group, Ilmenau, Germany) will be used for the sham tES in the AD group.
15922822|NCT03475433|Device|Actigraphy device|Both groups will receive an actigraphy device that will passively measure their movement data.
15922823|NCT03475407|Drug|Ozurdex intravitreal injection|"Ozurdex intravitreal injection and Antreior Chamber(AC) paracentesis at baseline
~AC paracentesis at 6 wk
~intravitreal Ozurdex injection and AC paracentesis at 18wk or 24wk"
15922824|NCT03475394|Other|Chlorhexidine gel|0.1 ml of Chlorhexidine gel was administered into the periodontal pocket followed by Coe- pack application.
15922825|NCT03475394|Other|Morus alba gel|0.1 ml of Morus alba gel was administered into the periodontal pocket followed by Coe- pack application.
15922826|NCT03475394|Other|Placebo|No gel is applied
15922827|NCT03475381|Drug|Ivacaftor+lumacaftor|1 year follow-up after initiation of ivacaftor+lumacaftor
15922828|NCT03475368|Other|Vegetarian diet|People randomized to this interventional group will take a vegetarian diet (i.e. without animal products, except milk and eggs).
15922829|NCT03475368|Other|Low carbs diet|People randomized to this interventional group will take low carbs diet (i.e. with a limited amount of carbohydrates)
15922830|NCT03475368|Other|Mediterranean diet|People randomized to this interventional group will take a traditional Mediterranean diet.
15922831|NCT03475355|Behavioral|Live movement observation (Upper Limbs)|"All participants will be subjected to two 15-minute sessions per day of the Live movement observation of the upper limbs. The activities of the upper limbs will be based on some relevant activities of daily life such as drinking from a glass, combing, opening a box or eating an apple. The tasks will be both unimanual and bimanual.
~Every day, before starting the physical training, the patient will be asked to look carefully at the therapist who shows 20 different daily routine activities (actions) performed with the upper limb."
15922832|NCT03475355|Behavioral|Video Observation (Upper Limbs)|"All participants will be subjected to two 15-minute sessions per day of the video observation of upper limbs movements. The activities of the upper limbs will be based on some relevant activities of daily life such as drinking from a glass, combing, opening a box or eating an apple. The tasks will be both unimanual and bimanual.
~Every day, before starting the physical training, the patient will be asked to carefully watch a video showing 20 different daily routine activities (actions) performed with the upper limb."
15922889|NCT03474952|Procedure|remote ischemic preconditioning (RIPC)|remote ischemic preconditioning consists of 4 cycles of 5-min ischemia and subsequent 5-min reperfusion using pneumatic cuff applied to upper arm
15922833|NCT03475355|Behavioral|Live Movement Observation (Lowe Limbs)|"All participants will be subjected to two 15-minute sessions per day of the Live movement observation of the lower limbs. Tasks to avoid freezing will be based on strategies such as touching the thigh, taking side or back steps, counting out loud while walking.
~Every day, before starting the physical training, the patient will be asked to carefully watch the therapist who will show 20 different movement strategies to avoid episodes of freezing the pace (FOG)."
15922834|NCT03475355|Behavioral|Video Observation (Lower Limbs)|All participants will be subjected to two 15-minute sessions per day of the video observation of lower limbs movements. Tasks to avoid freezing will be based on strategies such as touching the thigh, taking side or back steps, counting out loud while walking. Every day, before starting the physical training, the patient will be asked to carefully watch a video that will show 20 different movement strategies to avoid episodes of freezing the pace (FOG).
15922835|NCT03475355|Behavioral|Static Picture Observation and Upper Limbs Exercise|"Participants will watch for 3 minutes 5 static images that expose objects, none will represent animals or people.
~The participant's attention will be kept high through a cognitive task. The patient will be presented a sequence of images for 3 minutes, the images will be displayed separately, each for 30 seconds, and then during the last 30 seconds, they will be displayed together with an intrusive image (intruder) that the patient you will be asked to identify so that your attention span can be controlled in real time. Participants will then be invited to perform limb movements as far as possible for 2 minutes according to a standard sequence involving joint mobilisations of upper limbs, and simulating that performed by the experimental groups."
15922836|NCT03475355|Behavioral|Static Picture Observation and Lower Limbs Exercise|"Participants will watch for 3 minutes 5 static images that expose objects, none will represent animals or people.
~The participant's attention will be kept high through a cognitive task. The patient will be presented a sequence of images for 3 minutes, the images will be displayed separately, each for 30 seconds, and then during the last 30 seconds, they will be displayed together with an intrusive image (intruder) that the patient you will be asked to identify so that your attention span can be controlled in real time. Participants will then be invited to perform limb movements as far as possible for 2 minutes according to a standard sequence involving joint mobilisations of lower limbs, and simulating that performed by the experimental groups."
15922837|NCT03475342|Drug|Tranexamic Acid|Ampoules and packaging for both arms will be identical in appearance.
15922838|NCT03475342|Other|Placebo|Ampoules and packaging for both arms will be identical in appearance.
15922839|NCT03475329|Other|adenotonsillectomy|adenoidectomy with bilateral tonsillectomy versus adenoidectomy with unilateral complete tonsillectomy
15922840|NCT03475316|Behavioral|Social Dancing|90-min dance sessions twice weekly for 6-months. The session includes warm-up, dance and cool down.
15922841|NCT03475316|Behavioral|Treadmill Walking|Each session starts with 5-10 minutes of warm-up walking at comfortable speed. Speed is gradually increased to the level at which participants felt it is 'somewhat hard' for two 35 minute sessions with breaks in between followed by 5-10 minute cool down period (total 90 min to match dance group).
15922842|NCT03475303|Behavioral|early hospital discharge|early hospital discharge at 8-12 hours for women undergone elective cesarean section
15922843|NCT03475290|Behavioral|Personal resources' enhancement: self-efficacy and perceived social support|The condition reflects cultivation hypothesis and consists of 2 sequential modules with self-efficacy enhancement module (SE) preceding perceived social support enhancement module (SS). Each module is comprised of 3 evidence-based, CBT-framed exercises: 1) SE: mastery experience, vicarious experience, and action planning, 2) SS: received support & cognitive distortions, social skills & peer support, action planning. Participants will have an option to engage in one or more out of four additional modules: relaxation, cognitive reconstruction, mindfulness, and lifestyle. The condition takes 6 weeks, 1 week per exercise.
15922844|NCT03475290|Behavioral|Personal resources' enhancement: perceived social support and self-efficacy|The condition reflects enabling hypothesis and consists of 2 sequential modules with perceived social support enhancement module (SS) preceding self-efficacy enhancement module (SE). Each module is comprised of 3 evidence-based, CBT-framed exercises: 1) SS: received support & cognitive distortions, social skills & peer support, and action planning, 2) SE: mastery experience, vicarious experience, and action planning. Participants will have an option to engage in one or more out of four additional modules: relaxation, cognitive reconstruction, mindfulness, and lifestyle. The condition takes 6 weeks, 1 week per exercise.
15922845|NCT03475290|Behavioral|Personal resources' enhancement: self-efficacy|The condition consists of self-efficacy enhancement module (SE) and is comprised of 3 evidence-based, CBT-framed exercises: mastery experience, vicarious experience, and action planning. Participants will have an option to engage in one or more out of four additional modules: relaxation, cognitive reconstruction, mindfulness, and lifestyle. The condition takes 3 weeks, 1 week per exercise.
15922846|NCT03475290|Behavioral|Personal resources' enhancement: perceived social support|The condition consists of perceived social support enhancement module (SS) and is comprised of 3 evidence-based, CBT-framed exercises: received support & cognitive distortions, social skills & peer support, and action planning. Participants will have an option to engage in one or more out of four additional modules: relaxation, cognitive reconstruction, mindfulness, and lifestyle. The condition takes 3 weeks, 1 week per exercise.
15922847|NCT03475277|Drug|Ketamine|Acute administration
15922848|NCT03475264|Diagnostic Test|Lung MRI|Participants will be undergoing hyperpolarized xenon and proton lung MRI
15922849|NCT03475251|Biological|CS1003|In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme. In the dose expansion part, patients will be assigned to different groups based on their tumor type.
15922850|NCT03475251|Biological|CS1003|CS1003 to be intravenously administered at the dose level determined during the dose escalation part
15922851|NCT03475251|Drug|Regorafenib|Regorafenib to be orally administered at the protocol-specified dose level, once daily for the first 21 days of each 28-day cycle
15922852|NCT03475238|Procedure|Nursing care|The nursing care will be defined as a lateral mobibization and a length of care superior or equal to 10 min
15922853|NCT03475225|Drug|Cholecalciferol|Cholecalciferol delivery
15922854|NCT03475225|Drug|Placebo Oral|manufactured to mimic Cholecalciferol
15922890|NCT03474952|Procedure|sham-RIPC|ischemia pressure less than 10 mmHg (sham-RIPC)
15922891|NCT03474939|Drug|Midazolam Oral Tablet|Midazolam Oral tablet
15950175|NCT03262974|Diagnostic Test|PCR|PCR
15922855|NCT03475212|Biological|Virus Specific T-cell (VST) infusion|Patients will receive partially HLA-matched VSTs as a single infusion. Patients who have a partial response (>1 log decrease in viral load without clearance) or no response and do not have treatment-related dose-limiting toxicities are eligible to receive up to 3 additional doses from day 30 after the initial infusion and at 2 weekly intervals thereafter. The viral load of the virus (or viruses) that patients are initially treated for are monitored by viral PCR.
15922856|NCT03475199|Device|FabLife|"A personnalized dietary program depending on the patient's phenotype and genotype
~The daily intake of a dietary supplement, developped in the context of male infertility."
15922857|NCT03475186|Drug|Ramipril|2.5 - 5 mg oral, 1x daily for 22 weeks
15922858|NCT03475173|Device|LSFG-NAVI|laser-speckle blood flow of ocular arteries and veins
15922859|NCT03475160|Drug|Sildenafil Citrate vaginal suppositories|Sildenafil citrate vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
15922860|NCT03475160|Drug|Placebo vaginal suppositories|Placebo vaginal suppositories. Uterine artery Doppler before treatment. Uterine artery Doppler after treatment.
15922861|NCT03475160|Procedure|Uterine artery Doppler before treatment|Uterine artery Doppler before treatment: Uterine artery Doppler indices; PI and RI at cycle days 21-23 of the cycle preceding the pregnancy
15922862|NCT03475160|Procedure|Uterine artery Doppler after treatment|Uterine artery Doppler after treatment: Uterine artery Doppler indices; PI and RI at the twelfth week of gestation
15922863|NCT03475147|Device|eyeFusion|Smartphone app based flicker fusion test.
15922864|NCT03475134|Other|TIL|Adoptive transfer of Autologous Tumor-Infiltrating Lymphocytes
15922865|NCT03475134|Drug|Cyclophosphamide|Cyclophosphamide will be administered as an intravenous (IV) infusion for two days.
15922866|NCT03475134|Drug|Fludarabine|Fludarabine will be administered as an intravenous (IV) infusion for five days.
15922867|NCT03475134|Drug|Interleukin-2|After TIL infusion, IL-2 (optional) will be started as a bolus administration every eight hours, for a maximum of eight doses.
15922868|NCT03475134|Drug|Nivolumab|Nivolumab will be administered for maximum 24 months as follows: first year: 240 mg every 2 weeks; second year: 480 mg every 4 weeks.
15922869|NCT03475121|Combination Product|Combination Chemotherapy plus Intrathecal Topotecan|Adjuvant chemotherapy with a reduced dose (compared to GALOP I protocol) of carboplatin
15922870|NCT03475121|Combination Product|Higher Dose Combination Chemotherapy plus Intrathecal Topotecan|GALOP I-based systemic adjuvant therapy plus intrathecal topotecan
15922871|NCT03475121|Combination Product|Higher Dose Combination Chemotherapy plus Intrathecal Topotecan and Orbital Radiotherapy|GALOP I-based systemic adjuvant therapy plus intrathecal topotecan and orbital radiotherapy (45 Gy) up to chiasm
15922872|NCT03475121|Other|No Adjuvant Therapy|Patients will not receive any adjuvant therapy after enucleation of the affected eye.
15922873|NCT03475108|Other|Community Health Worker added to diabetes team|A Community Health Worker will be added to the diabetes team caring for a child with type 1 diabetes over 1 year. The intervention includes social determinants of health screening and goal setting, with home visits.
15922874|NCT03475095|Other|Tuina|Patients will receive Tuina therapies tiwce per week in one month.each time lasts about 20 minutes,a total of 4 weeks.
15922875|NCT03475082|Device|Transcutaneous Electrical Nerve Stimulation|Transcutaneous electrical nerve stimulation (TENS) is utilized clinically by a variety of health care professionals for the reduction of pain. The mechanisms by which TENS produces analgesia or reduces pain are only recently being elucidated. TENS is a non-invasive modality that is inexpensive, safe and easy to use with relatively few contraindications. Frequency of stimulation is broadly classified as high frequency (>50Hz), low frequency (<10Hz) TENS. Intensity is determined by the response of the patient as either sensory level (low-intensity) TENS strong but comfortable. With sensory level TENS, the voltage (i.e. amplitude) is increased only until the patient feels a comfortable tingling (perceived with high frequency) or tapping (perceived with low frequency) sensation without motor contraction. With strong but comfortable TENS the intensity is increased to a strong but comfortable level which may include muscle contraction.
15922876|NCT03475069|Other|Custom Designed Exercises|
15922877|NCT03475069|Other|Plates Exercises|
15922878|NCT03475069|Other|Calisthenics Exercises|
15922879|NCT03475056|Biological|cAd3-Marburg vaccine|The recombinant chimpanzee adenovirus Type 3-vectored Marburg vaccine, VRC-MARADC087-00-VP (cAd3-Marburg) is composed of a cAd3 vector that expresses Marburg wild type glycoprotein (WT GP).
15922880|NCT03475043|Behavioral|Auditory training: temporal cues|Behavioral training for 6-9 hours in listening to specific characteristics of acoustic signals. Listeners receive correct-answer feedback on each trial.
15922881|NCT03475030|Other|pre-filled medication trays|
15922882|NCT03475030|Other|automated medication reminders|
15922883|NCT03475017|Dietary Supplement|Active Comparator: Supplement A|The patients will receive 3 capsules per day containing 500mg of curcumin and 5mg of piperine for 4 weeks
15922884|NCT03475017|Dietary Supplement|Placebo Comparator: Supplement B|The patients will receive 3 capsules of placebo per day containing 500mg of maize starch for 4 weeks
15922885|NCT03475004|Drug|Pembrolizumab, Bevacizumab, and Binimetinib|"Cohort A: binimetinib 45mg, orally, twice a day, for 7 days. This will be followed by bevacizumab 7.5mg/kg on day 1 every 21 days and pembrolizumab 200mg on day 1 every 21 days. Binimetinib, 45mg, PO BID, should be taken on a continuous dosing schedule.
~Cohort B: bevacizumab 7.5mg/kg on day 1 every 21 days and pembrolizumab 200mg on day 1 every 21 days. Binimetinib, 45mg, PO BID, should be taken on a continuous dosing schedule."
15922886|NCT03474991|Drug|Celestamine®|Children in KIDS-STEP will be receiving either oral betamethasone (Celestamine®) or oral placebo dosed once daily for two consecutive days. Celestamine® N 0.5 liquidum is a betamethasone solution and will be used in the active comparator arm. Study medication will be administered orally once a day on two consecutive days. A standard dose of 0.1-0.2 mg/kg will be used. All doses used in KIDS-STEP fall into the range of recommended doses according to the Summary of Medical Product Characteristics.
15922887|NCT03474978|Device|Peripherally Inserted Central Venous Cather (PICC)|Location of the PICC insertion will be randomized and compared
15922888|NCT03474965|Drug|Crizanlizumab|Crizanlizumab (SEG101) is a concentrate for solution for infusion, i.v. use. Supplied in single use 10 mL vials at a concentration of 10 mg/mL. One vial contains 100 mg of crizanlizumab.
15950176|NCT03262974|Diagnostic Test|HPLC-UV|HPLC-UV
15922892|NCT03474939|Other|Placebo Oral Tablet|Glucose 1000mg tablet night before surgery and 60 minutes before surgery
15922893|NCT03474926|Procedure|Routine Template-based lymphadenectomy|"Template-based LND was carried out in all patients in this group. The anatomical extent of LND is described in previous study. Lymph node specimens were sampled en bloc with surrounding adipose tissue, and were sent to pathological examination as individual packets with the surrounding adipose tissue."
15922894|NCT03474926|Procedure|LND only for lymph nodes enlargement found in preoperative image or during surgery|LND was carried out only in patients who have lymph nodes enlargement in preoperative imaging (e.g. CTU or enhanced MRI) or who were found lymph nodes enlargement during surgery
15922895|NCT03474913|Device|Upright MRI|Indomitable Magnetic Resonance Imaging Scanner, magnetic resonance imaging using 0.6 T strength
15922896|NCT03474913|Device|Standard MRI|standard of care closed 3T MRI
15922897|NCT03474900|Device|PLGA implant, Bioretec ltd. Finland|The investigational implant is an ultra-high-strength biodegradable intramedullary (IM) nail of poly(lactide-co-glycolide) (PLGA)/tricalcium-phosphate (β-TCP) which was manufactured by Bioretec Ltd. (Hartmaninkatu 2, Tampere, Finland)
15922898|NCT03474900|Device|Titanium elastic stable nail|Elastic stable intramedullary nail to stabilize unstable forearm shaft fractures in children
15922899|NCT03474887|Other|Physical Consultation|Regular physician consultation at the primary care clinic.
15922900|NCT03474887|Other|Online Consultation|An online platform for communicating with a physician digitally. Patients answer a series of algorithm-based questions after specifying chief complaint, after which contact is established with a physician who can communicate through short messages. The physician can then order labs, prescribe relevant medication or book the patient for a physical consultation if need be.
15922901|NCT03474874|Device|NeoMatriX Collagen Dressing|Collagen wound dressing
15922902|NCT03474861|Biological|anticancer medication A01; immune cells IC01|"The administration of the anticancer medication A01 and immune cells IC01 will be performed in The Second Hospital of Jiaxing, Zhejiang, China.
~The subjects will be observed for any side effects during this time and all the adverse events will be recorded."
15922903|NCT03474848|Other|HABIT|Provision of individualized bimanual activities, individually chosen according to the child´s abilities, impairments and improvements in order to achieve success and to encourage bimanual use. Task difficulty is graded, focusing on enhancing the level of difficulty or speed, according to child's improvements. We use whole task practice (sequencing successive movements in the context of activities), part task practice (practice of specific components of the task in a repetitive sequence of time) and individualized functional goal training.
15922904|NCT03474848|Other|Conventional Occupational Therapy (OT)|Children will maintain the occupational therapy sessions with their therapists, without any change in their routine at the rehabilitation center. Strategies such as functional training, stretching and sensory stimulation are used.
15922905|NCT03474835|Diagnostic Test|ISCHEMIC HEART DISEASE diagnostic|ISCHEMIC HEART DISEASE diagnostic
15922906|NCT03474822|Biological|Blood-stage infection of P.vivax|The P. vivax infected blood will be confirmed to follow the national standard of blood donation to ensure that only P. vivax is included, excluding the presence of P. falciparum. Exclude other infectious diseases according to the test of national standard of blood donation.
15922907|NCT03474809|Device|Blood sampling|Daily blood samples which will be taken for the PSP measurement using the AbioScope as well as another daily sample taken for central analysis of biomarkers of inflammation, infection and/or sepsis (including but not limited to C-reactive protein [CRP] and Procalcitonin [PCT]).
15922908|NCT03474796|Behavioral|Eye-tracking|Visualisation of 4 photographic scenarios (surgical situations), questionnaire, eye-tracking
15922909|NCT03474783|Behavioral|Health education|Stages of change of intentions to cease smoking of participants at the baseline were determined, and a personal-tailored health education was accordingly delivered.
15922910|NCT03474770|Drug|BIS-001ER|BIS-001 ER is an extended release formulation of the nutritional supplement Huperzine A.
15922911|NCT03474757|Other|Data Collection|Data will be extracted from July 2009 to the last available database extraction
15922912|NCT03474744|Drug|Copanlisib|"Induction Phase Cycle 1-6 (28 days cycle):
~Copanlisib:
~60 mg i.v. fixed dose days 1, 8, 15.
~Rituximab:
~375 mg/m2 day 1 i.v."
15922913|NCT03474731|Behavioral|Diabetes Self Management Program|"Diabetes Self Management Program (DSMP) in a group setting: The goal of this arm of the project is to try to get participants to engage in better diabetes self-care (blood glucose testing, medication taking, diet, exercise, stress reduction, etc.).
~Groups randomized to one of two arms (DSMP only and CCN) will receive the DSMP. The DSMP has demonstrated significant improvements in communication with physicians, healthy eating, and hypoglycemia at six and twelve months. The DSMP and other self-management programs have been shown to increase self-efficacy, knowledge, and skill building; ensure accountability/monitoring; improve patient-provider interaction; leverage local assets; address sustainability, and be cost effective."
15922914|NCT03474731|Behavioral|Tailored Patient Navigation (PN) only|Tailored Patient Navigation (PN) only: The goal of this arm of the project is to try to get participants to attend their recommended medical appointments. PN has been shown to improve health behavior and increase self-efficacy, all with low costs. We will have to add an additional eligibility criterion for this group-they have to be out of compliance with medical appointments. Most participants will need PN services, owing to missed, rescheduled, or infrequent appointments. This means not attending their office visits, as recommended, which typically is every 3 months. We will interact with them to verify attendance and, at times, to access patient medical records if needed.
15922915|NCT03474731|Behavioral|DSMP AND Tailored Patient Navigation|DSMP AND Tailored Patient Navigation : Both group education classes and patient navigation
15922916|NCT03474718|Biological|Platelet-rich Plasma Left Side|Group A will receive PRP on left side of scalp and placebo (saline solution) on right side of scalp.
15922917|NCT03474718|Biological|Platelet-rich Plasma Right Side|Group B will receive PRP on right side of scalp and placebo (saline solution) on left side of scalp.
15922941|NCT03474471|Behavioral|Pulmonary rehabilitation|Following a PR program
15950177|NCT03262961|Drug|Sildenafil 20 MG|
15922918|NCT03474705|Device|Eccentric Training Protocol|A custom-built dynamic shoulder dynamometer (Aalborg University, Aalborg, Denmark) will be used. Participants will be seated with back support and no feet support. The maximal voluntary contraction (MVC) of the painful side will be assessed. Sessions will start with a 5-min warm-up. After that, participants will sit in the dynamometer, and the range of shoulder elevation (highest and lowest vertical position) will be measured for the affected side. During training, subjects will have to counteract a dynamometer vertical force from the highest to the lowest shoulder position at a force equal to 60% (training sessions 1-3), 70% (training sessions 4-6), and 80% (training sessions 7-10) of the MVC recorded during baseline. Three bouts of 10 repetitions (sessions 1-3), 8 repetitions (sessions 4-6) and 6 repetitions (sessions 7-10) will be performed, with a 3-second rest between contractions and a 2-minute break between bouts.
15922919|NCT03474679|Drug|Ibrutinib|Participants will receive 420 mg (3 * 140 mg capsules) oral ibrutinib once daily starting on Week 1 Day 1, unless they have intervening unacceptable toxicity or meet other criteria for participants discontinuation.
15922920|NCT03474666|Procedure|Strict Glycemic Control Group|The strict protocol adopted to conduct the study was proposed by Keegan e Cols.(2010) to be used among adult LT recipients that consist of a continuous intravenous insulin infusion. The targeted blood glucose range is 80-130 mg/dL. The procedure must be stopped when the patient can ingest at least 50% of liquid diet or receive bolus tube feedings.
15922921|NCT03474666|Procedure|Standard Glycemic Control Group|"The targeted blood glucose range is 130-180 mg/dL
~Blood glucose reading: ≤ 180 mg/dL - subcutaneous insulin dose: 0
~Blood glucose reading: ≥181 mg/dL and ≤250 mg/dL - subcutaneous insulin dose: 5 IU
~Blood glucose reading: ≥251 mg/dL and ≤300 mg/dL - subcutaneous insulin dose: 10 IU
~Blood glucose reading: ≥301 - subcutaneous insulin dose: 15 IU"
15922922|NCT03474640|Biological|Toripalimab, Recombinant Humanized anti-PD-1 Monoclonal Antibody|Toripalimab is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically.
15922923|NCT03474627|Device|Non-coated HA/TCP particles|Maxillary sinus floor elevation and bone grafting with the use of biphasic hydroxyapatite and beta-tricalcium phosphate bone graft
15922924|NCT03474627|Device|PLGA-coated HA/TCP particles|Maxillary sinus floor elevation and bone grafting with the use of biphasic hydroxyapatite and beta-tricalcium phosphate bone graft with PLGA coating
15922925|NCT03474614|Drug|Propranolol|The medication will be administered so that patient receives a minimum of 7- days and maximum of 10-days of treatment with propranolol prior to planned surgical resection of CCM (routine care)
15922926|NCT03474614|Genetic|DNA and RNA Analysis|During the operative procedure, a small sample of the patient's blood will be obtained and small (1 to 2cc) tissue sample from the resected cavernous malformation will be collected. The blood and tissue samples will be labeled and stored for subsequent DNA and RNA analysis
15922927|NCT03474601|Other|Dynamic hormone study and Magnetic resonance imaging|"Medical history
~Imaging examination including brain magnetic resonance imaging
~Blood (Basal hormone study and follow-up study) and pituitary tumor tissue"
15922928|NCT03474588|Behavioral|Standard treatment (ST) PLUS web-based CBT4CBT|Participants will have access to the CBT4CBT website in Spanish as an add-on to treatment. In this treatment participants will work with a computerized program that teaches skills for stopping alcohol use and increasing coping skills, such as how to understand patterns of alcohol use, how to cope with cravings for alcohol, how to refuse offers of alcohol, and so on
15922929|NCT03474588|Behavioral|Standard Treatment (ST)|ST includes individual and group therapy sessions and regular urine monitoring. Sessions will generally last for 1 hour one time per week for 8 weeks
15922930|NCT03474575|Other|Prevention|The purpose is to establish a safe and effective way of discharging COPD patients from emergency department by providing enhanced home care.
15922931|NCT03474562|Drug|Duowell®|Telmisartan/Rosuvastatin 40/20mg (increased to Telmisartan 80mg if SBP > 140mmHg or DBP > 90mmHg at week 12)
15922932|NCT03474562|Drug|Monorova® + Amlopin®|Rosuvastatin 20mg + Amlodipine 5mg (increased to Amlodipine 10mg if SBP > 140mmHg or DBP > 90mmHg at week 12)
15922933|NCT03474549|Device|Tigertriever revascularization device|Mechanical Thrombectomy
15922934|NCT03474523|Other|Experimental group|"Cavitation: 70% intensity, 30 minutes apply plane electrode and 10 minutes focal electrode.
~Presotherapy: 30 minutes application of 35% intensity, compression 35seg, pause 15seg, speed 9"
15922935|NCT03474523|Other|Control group|"Diathermy-Radiofrecuency: 30 minutes at 70% intensity (40-43ºC) in manual resistive modality and 10 minutes in automatic capacitive modality.
~Presotherapy: 30 minutes application of 35% intensity, compression 35seg, pause 15seg, speed 9"
15922936|NCT03474510|Drug|local infiltration of liposomal bupivacaine|Those patients randomized to receive LIA of EXPAREL will have 266mg EXPAREL diluted to 100mL, and drawn into (5) 20mL syringes affixed with (5) 22-gauge needles. Investigators will administer the syringes to the tissue in small increments with the plunger held steady while withdrawn from the tissue to avoid saturating the area around the needle sticks since EXPAREL doesn't readily travel through the tissue.
15922937|NCT03474510|Other|continuous infusion of ropivacaine interscalene nerve block|"All patients will receive a single injection of 30mL, 0.5% preservative-free ropivacaine.
~Those patients randomized to receive CINB will then have an indwelling catheter placed and held in place by Dermabond and Tegaderm. Placement will be confirmed by ultrasound. Patients will then receive 0.2% preservative-free ropivacaine at 8mL/hr beginning at the conclusion of surgery and delivered for approximately 50 hours (or finish of 400mL) via elastomeric infusion system (OnQ Pain Relief System: Select A Flow, Kimberly-Clark Corporation, Roswell, Georgia). Patients are instructed prior to discharge how to pull the catheters at home. Patients may also return to surgeon's office for catheter removal once the pain ball is empty if they prefer."
15922942|NCT03474471|Device|EBV treatment|Bronchoscopic lung volume reduction using endobronchial valves (EBV)
15922943|NCT03474458|Drug|Doxycycline|Doxycycline
15922945|NCT03474445|Procedure|Volar Plate Osteosynthesis Aptus 2.5|Volar plating of distal radius fracture. Device: Aptus 2.5
15922946|NCT03474445|Procedure|Volar Plate Osteosynthesis Inteos 2.5|Volar plating of distal radius fracture. Device: Inteos 2.5
15922947|NCT03474432|Device|Optical Coherence Tomography|OCT will be performed with the St. Jude OCT system. Detection of metallic stent struts will be performed automatically with manual adjustments made as necessary. Stent area tracings will be automatically performed by interpolated contours connecting the center point of the luminal surface of each detected metallic strut. Stent expansion will be determined as the minimum stent area divided by the average reference lumen area and presented as a percentage. Neo-intimal hyperplasia (NIH) area will be determined in follow-up examinations as the area between the stent and lumen contours. Incomplete stent apposition (ISA) area will be determined as the area between the stent contour and the lumen contour at the site of malapposed struts, in a region not overlying a side branch ostium.
15922948|NCT03474419|Procedure|laser surgery|laser surgery
15922949|NCT03474406|Other|follow up system and multimodality approach|To provide a new service system for cancer pain in pain clinic by early detecting red flag sign to consult other departments, early alleviating severe pain, following patients intensively by telephone call and giving pain education
15922950|NCT03474393|Other|systematic intensive therapy|intensive telephone och internet Contact with diabetes nurse for coaching and guidance over 4 months and 4 Control visits
15922951|NCT03474380|Behavioral|iHI-FIVES|Implementation of iHI-FIVES caregiver skills training
15922952|NCT03474354|Device|chemoembolization|correlation of necrosis with the deposition of beads
15922953|NCT03474341|Diagnostic Test|MRI|"Anatomical (T2W) and functional MRI (DWI and DCE) at a 1.5T Siemens or Philips scanner
~DWI series: sagittal (sIVIM) and high-resolution transversal (HR tDWI)
~DCE serie: dynamic20
~In total, three MRI scan series (before, during, after nCRT)
~Measurements: i.a. change in apparent diffusion coefficient (ADC) or area-under-the-gadolinium-concentration time curve (AUC) within tumor delineation over time, radiological (qualitative) assessment of residual disease"
15922954|NCT03474341|Diagnostic Test|PET-CT|"According to European Association of Nuclear Medicine (EANM) Research Ltd guidelines (EARL)
~In total one additional PET-CT (during nCRT) for study purposes. A PET-CT scan at diagnosis and after nCRT are included in the standard diagnostic work-up for esophageal cancer.
~Measurements: i.a. change in TLG (Total Lesion Glycolysis), SUVmax (Standardized Uptake Value) or Ktrans within tumor delineation over time"
15922955|NCT03474341|Diagnostic Test|Endoscopy|Additional endoscopy and/or endoscopic ultrasonography (EUS) with biopsies of the primary tumor site and other suspected lesions in the esophagus after completion of nCRT and prior to surgery
15922956|NCT03474341|Diagnostic Test|Blood samples|"Blood samples at three different time points (before, during and after nCRT) will be collected
~Blood will be collected in cell-free DNA collection tubes
~Purpose: isolation of ctDNA and subsequent mutation analysis by means of Next Generation Sequencing
~Measurements: the presence of, and changes in, ctDNA during nCRT"
15922957|NCT03474328|Device|AlcoChange|Smartphone app and breathalyser
15922958|NCT03474315|Diagnostic Test|Multivariate assessment|Patient's status assessment according to clinical evaluation and data acquired from the implanted device.
15922959|NCT03474302|Behavioral|Physical Activity|Aerobic, strength training, balance, flexibility
15922960|NCT03474302|Other|Successful Aging|Healthy aging education
15922961|NCT03474289|Drug|SHR-1316|Monotherapy
15922962|NCT03474276|Drug|Azythromycin|Administration of azythromycin to the child at inclusion (3 days) 20 mgs/kgs/day : three days
15922963|NCT03474276|Dietary Supplement|Inuline and fructo-oligosaccharides|Administration of inuline and fructo-oligosaccharides (Synergy1) 2g/day, mixed with the fortified blend flour given to the child through the whole intervention.
15922964|NCT03474276|Drug|Albendazole|Administration of Albendazole at inclusion of the child : 200mgs, one administration
15922965|NCT03474276|Dietary Supplement|Fortified blend flour|"Children from 6 to 11 months : 200 grams / day Children from 12 to 24 months : 300 grams / day
~Compostion of the fortified blend flour per 100 grams : either :
~Mil (whole grains): 58,56 g/100g, Soybeans (fat meal): 16,54g/100g Peanuts (roasted seeds): 8,75g/100g, Cane sugar: 7,35 g/100g Whole milk (Powder): 7,56g/100g, MSV MAM: 0,28g/100g, iodized salt :0,45g/100g, CaC03: 0,48g/100g,Amylase BAN: 0,03g/100g OR Corn (whole grains): 53,29g/100g, Soybeans (dry seeds): 17,82g/100g, Peanuts (roasted seeds): 9,00 g/100g, Cane sugar: 11,00 Whole milk (Powder): 5,00g/100g, Soybean Oil (Purified): 1,24g/100g, Peanut oil (Purified): 1,13g/100g, MSV MAM: 0,27g/100g, iodized salt: 0,53 g/100g, Ca3(PO4)2: 0,62g/100g, KCl: 0,09g/100g"
15922966|NCT03474263|Biological|Biologic: IC14 (monoclonal antibody against human CD14)|IC14 intravenous infusion daily for four days on two successive weeks then MR-PET Scan evaluation for impact on glial activation.
15922967|NCT03474250|Diagnostic Test|Magnetic Resonance test for kidney|Magnetic Resonance test for kidney
15922968|NCT03474237|Other|Hormone study and Imaging study|"Blood (basal hormone and follow up hormone study)
~Imaging examination including computed tomography scan or magnetic resonance imaging"
15922969|NCT03474224|Device|Ev1000 Clinical Platform from Edwards Lifesciences|The EV1000 Hemodynamic monitoring platform will be used to guide fluid administration following a volume-based parameter such the stroke volume.
15922970|NCT03474198|Drug|Rifampicin|10mg/kg
15922971|NCT03474198|Drug|Isoniazid|5mg/kg
15922972|NCT03474198|Drug|Pyrazinamide|25mg/kg
15922973|NCT03474198|Drug|Ethambutol|15mg/kg
15922974|NCT03474198|Drug|Linezolid|600mg
15922975|NCT03474198|Drug|Clofazimine|200mg
15922976|NCT03474198|Drug|Rifapentine|1200mg
15922977|NCT03474198|Drug|Levofloxacin|1000mg
15922978|NCT03474198|Drug|Bedaquiline|400mg once daily for 2 weeks then 200mg 3x a week
15922979|NCT03474198|Drug|Rifampicin|35mg/kg
15922980|NCT03474185|Behavioral|Taking Charge of your Heart Health patient education classes|"Taking Charge of your Heart Health patient education classes held at TotalCardiology cardiac rehabilitation in Calgary, Canada. Consists of four, 2.5-hour long group-based classes focused on focused on physiology, risk factors, medications, nutrition, exercise, and stress management"
15923009|NCT03474029|Drug|Rifapentine daily for 6 weeks|600 mg of Rifapentine (RPT) given once daily (o.d., omni die) for 6 weeks (6wP).
15923164|NCT03472833|Drug|Standard dose|Patients will receive a standard dose - 800 I.U. (equals 2 drops) of Vitamin D3 orally for 60 days
15922981|NCT03474172|Device|Cloak Shape Device for Sham Tuina|The Cloak Shape Device for Sham Tuina is exactly the same as the real one, which is opaque and big enough to cover the whole body and arms of a child who is under 6 years old. Two narrow holes are required on the cover, so that the therapist's hands can touch the child through these holes and a sham Tuina will be manipulated
15922982|NCT03474172|Device|Cloak Shape Device for Genuine Tuina|The Cloak Shape Device for Genuine Tuina is opaque and big enough to cover the whole body and arms of a child who is under 6 years old. Two narrow holes are required on the cover, so that the therapist's hands can touch the child through these holes and a genuine Tuina will be manipulated.
15922983|NCT03474159|Device|Magnetic Resonance Imaging|Aortic distensibility measured in MRI at the Valsalva sinus and at the ascending tubular aortic level
15922984|NCT03474159|Device|Transthoracic echocardiography|Aortic distensibility measured in TTE of the same segments in TM and in B mode
15922985|NCT03474159|Device|Echography UltraFast|Carotid pulse rate measured on carotid arteries by UF
15922986|NCT03474146|Other|Ocimum sanctum|Ocimum sanctum (known as Tulsi, Holy basil) is natural herb which is known for its broad spectrum medicinal properties. Ocimum sanctum is one of the best examples of Ayurveda's holistic lifestyle approach to health. It is also been well practiced in traditional medicine in India and south Asian region. Literature showed that Ocimum sanctum extract have significant anti-gingivitis and anti-inflammatory effect as mouthrinse.
15922987|NCT03474146|Other|Chlorhexidine Gluconate|Chlorhexidine Gluconate (C34H54Cl2N10O14) is a bisbiguanide formulation with cationic properties. Chlorhexidine over a period of over 40 years has been thoroughly investigated and successfully used as plaque control agent in dental practice. A literature review, highlighting chlorhexidine as not only a plaque control agent but also as an effective antimicrobial agent and its wider application in variety of oral disorders in various formulations.
15922988|NCT03474146|Other|Propylene Glycol|Propylene glycol or 1,2-dihydroxypropane or 1,2-propanediol, is a clear, colourless, viscous, practically odourless liquid with a density of 1.038 g/cm³ at 20 °C and a molecular weight of 76.095. It is miscible with water, acetone and chloroform. It is miscible in water. Propylene glycol is commonly used as an excipient in a variety of drugs and it is also authorised in food products and cosmetics.
15922989|NCT03474133|Drug|Brentuximab Vedotin|brentuximab vedotin 1,8 mg/kg, intravenous infusion every 21 days, up to 16 infusions per patient during study period
15922990|NCT03474120|Procedure|IVF treatment|Relationship between IVF treatment outcome and genotypes in POI//DOR/ovarian dysgenesis patients
15922995|NCT03474094|Combination Product|Pre-operative radiotherapy followed by 2 cycles of atezolizumab then surgery|"W1,W2, W3, W4 & W5: RADIOTHERAPY. A 3-dimensional conformal RT (3D-CRT) with photons ≥ 6MV will be realized based on the acquisition of a CT-scan performed in treatment position. Intensity modulated RT (IMRT), volumetric modulated arc therapy (VMAT) and tomotherapy are authorized.
~W6 and W9: ATEZOLIZUMAB IV INJECTION. 2 injections of 1200 mg of atezolizumab with a 3-week interval
~W11: SURGERY. Surgery should be performed as per Institutional practice by a surgeon with appropriate training in the treatment of sarcoma. The primary aim of surgery is to completely excise the tumor with a margin of normal tissue commonly accepted as 1 cm soft tissue, or equivalent"
15922996|NCT03474094|Combination Product|2 cycles of atezolizumab followed by surgery then post-operative radiotherapy|"W1 and W4: ATEZOLIZUMAB IV INJECTION. 2 injections of 1200 mg of atezolizumab with a 3-week interval
~W6: SURGERY Surgery should be performed as per Institutional practice by a surgeon with appropriate training in the treatment of sarcoma. The primary aim of surgery is to completely excise the tumor with a margin of normal tissue commonly accepted as 1 cm soft tissue, or equivalent
~W7, W8, W9, W10 & W11: RADIOTHERAPY A 3-dimensional conformal RT (3D-CRT) with photons ≥ 6MV will be realized based on the acquisition of a CT-scan performed in treatment position. Intensity modulated RT (IMRT), volumetric modulated arc therapy (VMAT) and tomotherapy are authorized."
15922997|NCT03474094|Combination Product|Pre-operative radiotherapy followed by surgery then 2 cycles of atezolizumab.|"W1,W2, W3, W4 & W5: RADIOTHERAPY A 3-dimensional conformal RT (3D-CRT) with photons ≥ 6MV will be realized based on the acquisition of a CT-scan performed in treatment position. Intensity modulated RT (IMRT), volumetric modulated arc therapy (VMAT) and tomotherapy are authorized.
~W6: SURGERY Surgery should be performed as per Institutional practice by a surgeon with appropriate training in the treatment of sarcoma. The primary aim of surgery is to completely excise the tumor with a margin of normal tissue commonly accepted as 1 cm soft tissue, or equivalent
~W11 and W14: ATEZOLIZUMAB IV INJECTION. 2 injections of 1200 mg of atezolizumab with a 3-week interval"
15922998|NCT03474081|Drug|FF/UMEC/VI|A single inhaler triple therapy of FF/UMEC/VI will be provided via ELLIPTA DPI. FF/UMEC/VI will be available as dry white powder with dosing strengths of 100/25/62.5 mcg per blister.
15922999|NCT03474081|Drug|Tiotropium|Tiotropium will be provided as a hard gelatin capsule for oral inhalation containing 18 mcg tiotropium bromide blended with lactose, administered via HANDIHALER DPI.
15923000|NCT03474081|Drug|Albuterol/salbutamol|Albuterol/salbutamol will be provided as an inhalation via MDI with a spacer or nebules and will be given as a rescue medication throughout the study.
15923001|NCT03474081|Drug|Placebo to match FF/UMEC/VI|Placebo matching FF/UMEC/VI will be available as a dry white powder of lactose or magnesium stearate, administered via ELLIPTA DPI.
15923002|NCT03474081|Drug|Placebo to match tiotropium|Placebo will be given as hard gelatin capsule for oral inhalation containing lactose, administered via HANDIHALER DPI.
15923003|NCT03474081|Device|ELLIPTA inhaler|ELLIPTA DPI will contain two individual blister strips with 30 blisters per strip. FF/UMEC/VI and placebo to match FF/UMEC/VI will be administered to the subjects using ELLIPTA DPI.
15923004|NCT03474081|Device|HANDIHALER|Tiotropium and placebo to match tiotropium will be administered to the subjects using HANDIHALER DPI.
15923005|NCT03474081|Device|MDI|Albuterol/salbutamol will be provided as a rescue medication throughout the study using MDI.
15923006|NCT03474055|Biological|Liquid Rotavirus Vaccine|Liquid Rotavirus Vaccine and Lyophilized Rotavirus Vaccine
15923007|NCT03474042|Drug|GLPG2737|GLPG2737 oral capsules administered twice daily for 28 days on top of Orkambi.
15923008|NCT03474042|Drug|Placebo|Placebo oral capsules administered twice daily for 28 days on top of Orkambi.
15923010|NCT03474029|Drug|Rifapentine and Isoniazid weekly for 12 weeks|"Rifapentine (RPT) 900 mg and isoniazid (INH) 900 mg given once-weekly for 12 weeks (3HP).*
~*Dose adjustments based on patient's weight will be made according to ATS/CDC/IDSA guidelines.
~RPT 900 mg once-weekly for persons weighing > 50 kg. For persons weighing < 50 kg, the following doses will be given: weight > 25-32 kg - RPT 600 mg; weight > 32-50 kg - RPT 750 mg; + INH 15 mg/kg (round up to nearest 50 or 100 mg; 900 mg max)."
15923011|NCT03474029|Drug|Rifampin and Isoniazid daily for 12 weeks|"Rifampin (RIF) 600 mg and Isoniazid (INH) 300 mg given once-daily for 12 weeks (3HR)*.
~*Dose adjustments based on patient's weight will be made according to ATS/CDC/IDSA guidelines.
~RIF 600 mg daily for persons weighing > 50 kg. For persons weighing < 50 kg, give 10 mg/kg daily; round up to nearest 50 or 100 mg; + INH 5 mg/kg daily (rounded up to nearest 50 or 100 mg; 300 mg max)."
15923012|NCT03474029|Drug|Rifampin daily for 16 weeks|"Rifampin (RIF) 600 mg given once-daily for 16 weeks (4R).*
~*Dose adjustments based on patient's weight will be made according to ATS/CDC/IDSA guidelines.
~RIF 600 mg daily for persons weighing > 50 kg. For persons weighing < 50 kg, 10 mg/kg daily; round up to nearest 50 or 100 mg."
15923013|NCT03474016|Diagnostic Test|Mammography-Histopathological examination of breast mass specimens- polymerase chain reaction|Mammography-Histopathological examination of breast mass specimens-Detection of long and short DNA fragments in serum using real-time quantitative polymerase chain reaction
15923014|NCT03474003|Other|No intervention|Kidney recipients aged over 18 and of all sexes recruited from 2002 in European and North American centers, who have eGFR follow-up and data from protocol and for cause biopsies available for allograft survival assessment; RCT conducted over the past 20 years with available data on protocol biopsy within the first year and follow up clinical, biological and histological data.
15923015|NCT03473990|Other|High-intensity interval training|2 minute warm up, followed by 5x1min HIT intervals separated by 90 seconds active recovery (walking on the spot) and then a 2 minute recovery period. The high intensity bouts will be a pyramid of exercises (star jumps, mountain climbers and on-the-spot sprints)
15923018|NCT03473964|Drug|H.P. Acthar gel|"H.P. Acthar gel:
~Injection 40 mg twice weekly"
15923019|NCT03473951|Diagnostic Test|Hyperuricemia|Hyperuricemia vs. normouricemia
15923020|NCT03473938|Device|Spatz3 AIGB|Implantation of Spatz3 AIGB balloon.
15923021|NCT03473925|Drug|Navarixin|Oral capsules
15923022|NCT03473925|Biological|Pembrolizumab|Intravenous infusion
15923023|NCT03473899|Device|rESWT|"rESWT will be performed as follows:
~Nine rESWT sessions
~Three sessions per week
~rESWT device: Swiss DolorClast (Electro Medical Systems, Nyon Switzerland), EvoBlue handpiece, 15 mm applicator
~2500 rESWs per session, with energy density between 0.12 and 0.16 mJ/mm^2, depending on what the patient tolerates
~rESWs applied at 15 Hz
~Application of rESWs in prone position, with the patient lying on an examination table
~Exact location of the application of rESWs determined by clinical and ultrasonographic examinations
~Treatment of both the side of injury and the entire affected muscle (from distal to proximal in order to relax the affected muscle)
~No use of local anesthesia.
~In addition, patients will receive a specific rehabilitation program."
15923024|NCT03473899|Device|Sham-rESWT|"Sham-rESWT will be performed as rESWT described in Arm rESWT + RP, but with a specially designed placebo EvoBlue handpiece that looks and sounds like the EvoBlue handpiece of the Swiss DolorClast, but does not generate radial shock waves. This is achieved by blocking the projectile shortly before it strikes the metal applicator. The placebo EvoBlue handpiece will not emit any radial shock wave energy.
~In addition, patients will receive a specific rehabilitation program."
15923025|NCT03473886|Behavioral|Intervention arm: PP-MI|The positive psychology exercises include gratitude-based activities, strengths-based activities, and meaning-based activities. The physical activity goal setting exercises include the following topics: health benefits, social resources, and neighborhood walkability.
15923026|NCT03473873|Other|Measures of muscle function|The participants will be assessed with various measures of muscle function at baseline and at follow up including: Isokinetic knee muscle strength, Isometric strength of trunk and lower extremity, single-leg hop for distance (SLHD), side hop, postural orientation errors (single leg-squat, stair descending, forward lunge, SLHD), hip and ankle range of motion, and muscular activation patterns.
15923027|NCT03473847|Device|ArcScan Insight 100 very high-frequency digital ultrasound|The ArcScan Insight 100 VHF digital ultrasound scanner can measure individual layers within the cornea with very high precision, as well as being able to image the interior of the eye including the chamber between the iris and the cornea, the lens and other structures behind the iris. The ArcScan Insight 100 device is a digital ultrasound scanner, meaning that it uses ultrasound waves to measure parameters of the eye. The Insight examination involves the patient sitting in front of the ultrasound unit and looking through a disposable goggle-like eyepiece at a light source. Warm sterile balanced saline solution (like natural tears) are used to fill the space between the light source and the eye, to allow ultrasound transmission. There is no contact between the instrument and the eye other than being immersed in this water bath.
15923028|NCT03473847|Device|Carl Zeiss Meditec Cirrus HD OCT 5000|The Cirrus HD OCT 5000 uses high definition spectral domain optical coherence tomography (OCT) to measure anatomical structures of the eye. OCT is non-contact and uses light, rather than ultrasound, to obtain cross-sectional images. An OCT scan involves the patient sitting in front of the device, placing their chin on a chin-rest and fixating on a light source. Nothing comes into contact with the eye and the patient is only aware of the instrument rotating in front of them.
15923029|NCT03473847|Device|Optovue RTVue OCT|The Optovue RTVue OCT uses high definition Fourier/spectral domain optical coherence tomography (OCT) to measure anatomical structures of the eye. OCT is non-contact and uses light, rather than ultrasound, to obtain cross-sectional images. An OCT scan involves the patient sitting in front of the device, placing their chin on a chin-rest and fixating on a light source. Nothing comes into contact with the eye and the patient is only aware of the instrument rotating in front of them.
15923065|NCT03473652|Other|Adapted walking platform|The walking sessions will be carried out on a suitable walking platform, including a connected play tablet.
15923165|NCT03472820|Other|Diet Recommendations|Specific dietary guidelines will be outlined for participants.
15923030|NCT03473847|Device|CSO MS-39 OCT|"The CSO MS-39 OCT uses high definition Fourier domain optical coherence tomography (OCT) to measure anatomical structures of the eye. OCT is non-contact and uses light, rather than ultrasound, to obtain cross-sectional images. The MS-39 also includes a Placido topographer within the device to simultaneously obtain a measurement of the shape (curvature) of the front surface of the cornea, which is then combined with the OCT thickness measurement to generate the shape of the back surface of the cornea.
~An OCT scan involves the patient sitting in front of the device, placing their chin on a chin-rest and fixating on a light source. Nothing comes into contact with the eye and the patient is only aware of the instrument rotating in front of them."
15923031|NCT03473834|Other|Modified exercise programme|The exercise will be modified from the standardized exercise program (Schenkman, 1998) includes a series of exercises based on the concept that muscle length and coordination.
15923032|NCT03473834|Behavioral|Medication|The control group will be received the normal medication from their doctor.
15923033|NCT03473821|Behavioral|MOTIFS|o MOTor Imagery to Facilitate Sensorimotor re-learning (MOTIFS) is an individualized and physical activity-specific integrated model that includes aspects of both neuromuscular training, as used in rehabilitation practices, and Dynamic Motor Imagery (DMI). DMI is a form of mental training in which the participant images him-/herself performing a task from a first-person perspective in order to maximize functional equivalence to the task in question. This includes dynamic, physical movement, as well as mental imaging. The intervention provides a framework for designing individualized, physical activity-specific rehabilitation exercises for knee-injured people.
15923034|NCT03473808|Behavioral|task-practice therapy|Standardized hand therapy program
15923035|NCT03473808|Other|Vibration|Peripheral vibration applied to the wrist skin at an imperceptible level
15923036|NCT03473795|Behavioral|Questionnaire forms|The questionnaires will include information such as socio-demographic data, risk factors, disease specific data, investigation and treatment details as well as findings during followup. Particular reference will be made to outcome measures such as local and distant recurrence, survival and mortality.
15923037|NCT03473795|Other|Bio-specimen samples|Samples can include tissue, blood, urine, saliva, hair and nail clipping.
15923038|NCT03473782|Other|Voiding Diary|A log kept by each patient to record frequency and volume of urine output and fluid input.
15923039|NCT03473782|Other|Urodynamics Correlation Study|Provides patho physiological data by assessing bladder sensation, bladder capacity, the presence of involuntary bladder contractions, bladder compliance and bladder outlet obstruction.
15923040|NCT03473769|Other|Vital Signs at 2 Hours|Patients vital signs assessed at 2 hours of arrival at ICU
15923041|NCT03473769|Other|Confusion Assessment method for the ICU (CAM-ICU)|patient must have altered mental status/fluctuating course and inattention, and either disorganized thinking or altered level of consciousness to be CAM positive; these features are determined by observing the patient during bedside cognitive testing.
15923042|NCT03473756|Drug|Rogaratinib (BAY1163877)|"Part A:Rogaratinib will be administered orally until disease progression, unacceptable toxicity or consent withdrawal. The starting dose of 800 mg b.i.d. will be confirmed using a dose selection design.
~Part B:Rogaratinib will be administered orally b.i.d. at the RP2D that was selected in Part A of Study 19131 on all 21 days in each cycle until centrally confirmed radiological disease progression, unacceptable toxicity or consent withdrawal"
15923043|NCT03473756|Drug|Atezolizumab|Part A & Part B: A fixed dose of 1200 mg atezolizumab will be administered through intravenous (i.v.) infusion on Day 1 of each 21-day cycle until disease progression, unacceptable toxicity or consent withdrawal.
15923044|NCT03473756|Drug|Placebo|Part B: Rogaratinib matching placebo will be administered orally b.i.d. at the RP2D that was selected in Part A of Study 19131 on all 21 days in each cycle until centrally confirmed radiological disease progression, unacceptable toxicity or consent withdrawal
15923045|NCT03473743|Drug|Erdafitinib|Participants will receive erdafitinib orally.
15923046|NCT03473743|Drug|Cetrelimab|Participants will receive cetrelimab by intravenous infusion.
15923047|NCT03473743|Drug|Cisplatin|Participants will receive cisplatin by intravenous infusion as a part of platinum chemotherapy.
15923048|NCT03473743|Drug|Carboplatin|Participants will receive carboplatin by intravenous infusion as a part of platinum chemotherapy.
15923049|NCT03473730|Procedure|Biopsy|Undergo biopsy
15923050|NCT03473730|Biological|Daratumumab|Given IV
15923051|NCT03473730|Other|Laboratory Biomarker Analysis|Correlative studies
15923052|NCT03473730|Procedure|Metastasectomy|Undergo metastasectomy
15923053|NCT03473730|Procedure|Nephrectomy|Undergo nephrectomy
15923054|NCT03473717|Device|classic method|"Put the Pozzi forceps to draw the uterus by the cervix to horizontalize it and align uterine cavity in the direct axis of cervix.
~Insert the hysterometer to measure the uterus depth.
~Locate the uterine depth on the inserter tube."
15923055|NCT03473717|Device|direct method|"Place the ring on the inserter tube 3 to 4 cm from the end as a marker.
~Insert the tube into the cervix until you feel the passage of the internal orifice of the cervix or until the ring is in contact with the external orifice of the cervix, the tube does not enter the uterine cavity"
15923056|NCT03473704|Behavioral|Treatment group (TG)|The Treatment group (TG) will receive the web treatment, which consists of 9 weekly sessions.
15923057|NCT03473704|Behavioral|Control group (CG)|For ethical reasons, the CG will receive the web treatment once the TG intervention has been completed (as long as it continues to meet the conditions of the study).
15923058|NCT03473691|Drug|Glembatumumab Vedotin|Standard neo-adjuvant dose-dense doxorubicin 60 mg/m2 and Cytoxan 600 mg/m2 IV every 14 days for 4 cycles followed by GV 1.9 mg/kg IV every 21 days for 4 cycles.
15923059|NCT03473678|Dietary Supplement|Nitrate-rich beetroot juice|concentrated beetroot juice
15923060|NCT03473678|Dietary Supplement|Nitrate-depleted beetroot juice|concentrated beetroot juice
15923061|NCT03473665|Drug|Indomethacin|Indomethacin Extended Release Oral Tablet 75mg every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
15923062|NCT03473665|Drug|Diclofenac|Diclofenac Delayed Release Oral Tablet 25mg tablets x 3 tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
15923063|NCT03473665|Drug|Meloxicam|meloxicam 7.5mg tablets every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
15923064|NCT03473665|Drug|Celecoxib|Celecoxib 200mg capsule every 12 hours for 6 weeks; omeprazole 20mg daily for 6 weeks
15923162|NCT03472846|Drug|Teriparatide|osteoanabolic treatment with Forsteo
15923066|NCT03473639|Drug|Entinostat|In metastatic breast cancer patients, entinostat will be taken orally starting at 3 mg per week and will increase to 5 mg per week in the absence of unacceptable side effects. The safe dose (when combined with capecitabine) will be confirmed in additional metastatic breast cancer patients and breast cancer patients with residual invasive disease following neoadjuvant chemotherapy and surgery.
15923067|NCT03473639|Drug|Capecitabine|In metastatic breast cancer patients, capecitabine will be taken by mouth starting at 800 mg/m2 twice a day for 14 days per cycle and increase to 1000 mg/m2 (for 14 days per cycle) in the absence of unacceptable side effects. The safe dose (when combined with capecitabine) will be confirmed in additional metastatic breast cancer patients and breast cancer patients with residual invasive disease following neoadjuvant chemotherapy and surgery.
15923068|NCT03473626|Drug|Alicaforsen|Alicaforsen tablet
15923069|NCT03473613|Drug|Oral Cabergoline|Giving oral Cabergoline tablet 0.5 milligram daily starting on ovum pick up day and continued for seven days
15923070|NCT03473613|Drug|Calcium Gluconate|Giving 10 ml of 10 % calcium gluconate on 200 ml normal saline solution o.9% intravenously over thirty minutes starting on ovum pick up day and continued for four days
15923071|NCT03473600|Procedure|Cryotherapy|Liquid Nitrogen spray
15923072|NCT03473600|Drug|Triamcinolone acetonide injection|Intralesional Triamcinolone Acetonide injection
15923073|NCT03473587|Behavioral|Motivational interview|A lay health advisor will engage the subject in a motivational interview to promote the importance of colorectal cancer screening
15923074|NCT03473587|Behavioral|Standard of care|A lay health advisor will provide the subject with a brochure promoting the importance of colorectal cancer screening
15923075|NCT03473574|Biological|Durvalumab|immune checkpoint inhibitor
15923076|NCT03473574|Drug|Gemcitabine|standard chemotherapy
15923077|NCT03473574|Drug|Cisplatin|standard chemotherapy
15923078|NCT03473574|Biological|Tremelimumab|immune checkpoint inhibitor
15923079|NCT03473561|Drug|Racecadotril plus ORS|Racecadotril plus ORS
15923080|NCT03473548|Device|Portable sleep monitor|Type III portable monitor obtaining greater than or equal to 6 hours of data adequate for polysomnography analysis and determination of an apnea hypopnea index (AHI), average SPO2, and SPO2 nadir.
15923081|NCT03473535|Combination Product|BEACON + Problem Solving Therapy|Six sessions of face-to-face PST delivered by a trained Research Therapist and access to the BEACON Suicide Prevention smartphone application.
15923082|NCT03473535|Behavioral|Problem-Solving Therapy|Six sessions of face-to-face PST delivered by a trained Research Therapist.
15923083|NCT03473522|Device|tDCS|Transcranial direct current stimulation is a modulation technique of neuronal excitability which has very promising results in Parkinson's disease. In addition to the possibility of increasing the excitability of areas to tDCS, it can also facilitate the execution of the exercises by increasing the excitability of the primary motor cortex and changing the recruitment strategies of the motor units.
15923084|NCT03473522|Behavioral|Exercise Therapy|Therapeutic exercises will be based on the literature (O'Sullivan and Schmitz 2004, Klamroth et al 2016, Reynolds et al., 2016, Pérez et al 2016, Smania et al., 2010, Pastor et al., 1993, Traub et al., 1980, Schoneburg et al., 2013) Each session will be divided into warm-up exercises; balance and relaxation, with a duration of 50 minutes and a frequency of 3 times a week. Training progresses and intensifies every two weeks. The subjects will perform five repeated movements of each exercise, evolving according to the condition of each patient (according to the Hoehn and Yahr staging scale).
15923085|NCT03473509|Other|CKD Registry|Health Service intervention
15923086|NCT03473496|Biological|CART therapy in Relapsed/Refractory multiple myeloma|one kind of BCMA/CD138/CD38/CD56-CART therapy in Relapsed/Refractory multiple myeloma
15923087|NCT03473483|Other|SREC|"The Standardized Research E-Cigarette (SREC) was developed by NIDA to help researchers assess uncertainties in electronic nicotine delivery devices.
~Tank:
~Sealed and disposable
~Minimum 350 puffs per tank
~Volume of e-liquid per tank ~ 3ml
~E-Liquid Characteristics:
~Tobacco flavored
~Nicotine concentration: 15 mg/ml
~Propylene Glycol:~ 50% (wt / wt)
~Glycerin: ~ 50% (wt / wt)
~Cotinine: <1 μg/g
~Nornicotine: 5 μg/g
~Myosmine : 3 μg/g
~Anabasine: <1 μg/g
~Anatabine: <1 μg/g
~Beta:nicotyrine: <1 μg/g
~Diacetyl: <2 μg/g
~2,3:Pentanedione: <1 μg/g
~Arsenic: <0.1 μg/g
~Cadmium: <0.1 μg/g
~Chromium: <0.1 μg/g
~Lead: <0.1 μg/g
~Nickel: <0.1 μg/g
~Mercury: <0.05 μg/g"
15923088|NCT03473470|Device|forced air warming and warmed intravenous fluids|Use of warming system (forced air)
15923089|NCT03473470|Device|warmed intravenous fluids|Use of warming system to have warmed intravenous fluids
15923090|NCT03473457|Biological|CART therapy in Acute myeloid leukemia(AML)|one kind of CD38-CART/CD33-CART/CD56-CART/CD123-CART/CD117-CART/CD133-CART/CD34-CART/Mucl-CART therapy in Acute myeloid leukemia(AML)
15923091|NCT03473431|Drug|Ketamine|single infusion of 0.5 mg / kg ketamine
15923092|NCT03473431|Other|control|physiological solution at 0.9 % with the same physical characteristics of ketamine solution,
15923093|NCT03473418|Drug|Ketoconazole|Ketoconazole as a topical vaginal gel
15923094|NCT03473418|Drug|Terconazole|Terconazole 80 mg as a topical vaginal cream
15923095|NCT03473405|Device|Air Barrier System|The Air Barrier System is a device that uses localized clean air flow to shield a surgery site from ambient airborne microorganisms that are shed into the air from people present in the operating room.
15923096|NCT03473405|Other|Control|The Air Barrier System will be deployed onto the surgical field, but the airflow will not be activated, so this is a sham control comparator.
15923099|NCT03473353|Other|Medical Scribe|Trained Medical Scribes will be present in the exam room to take notes on the the electronic medical record so that clinicians can focus all their attention to the interaction with the patient and parent.
15923163|NCT03472833|Drug|High-dose|Patients will receive a high dose - 180.000 I.U. (1 drop equals 400 I.U.) of Vitamin D3 orally on day 1, and then 4000 I.U. for 60 days
15923100|NCT03473340|Drug|Pirfenidone Capsule|"Dosing:
~Days 1 through 7, 267 mg three times daily; Days 8 through 14, 534 mg three times daily; Days 15 through end of treatment (24 weeks), 801 mg three times daily duration: 24 weeks"
15923101|NCT03473340|Drug|Placebo Capsule|"Dosing:
~Days 1 through 7, 267 mg three times daily;
~Days 8 through 14, 534 mg three times daily;
~Days 15 through end of treatment (24 weeks), 801 mg three times daily duration: 24 weeks"
15923102|NCT03473314|Drug|Nitric Oxide gas at 160ppm|Nitric oxide gas at 160 ppm inhaled three times daily for 50-80 min delivered with air as the carrier via inhalation for a maximum total of 90 days (extended 365 days twice). Total dose of 480 ppm hours per day.
15923103|NCT03473301|Biological|Infusion of allogeneic umbilical cord blood|Subjects will receive a single infusion of allogeneic umbilical cord blood at the baseline visit.
15923104|NCT03473301|Biological|Infusion of MSCs|Subjects will receive 3 infusions of MSCs (baseline, 3 months and 6 months).
15923105|NCT03473288|Behavioral|Exercise|Participants will undergo supervised exercise 3 times a week for 10-12 weeks.
15923106|NCT03473288|Behavioral|Sedentary|Participants will be asked to maintain the sedentary lifestyle that they already have for 10-12 weeks.
15923107|NCT03473275|Diagnostic Test|Cold Pressor test|Both feet in icy waterbath alternated with body temperature water
15923108|NCT03473275|Diagnostic Test|PinPrick test|Pricking both feet with a needle using gravity (without penetrating) alternated with cotton swap
15923109|NCT03473249|Drug|Contrast-Enhanced Ultrasound using Lumason|Subjects will undergo a contrast enhanced ultrasound (CEUS) during which a standard greyscale abdominal ultrasound is performed first followed by injection of intravenous contrast with Lumason, and completion of contrast-enhanced ultrasound
15923110|NCT03473236|Drug|GB002|Inhaled GB002
15923111|NCT03473236|Device|Generic Dry Powder Inhaler|dry powder inhaler used for inhalation of active drug or placebo
15923112|NCT03473236|Drug|Placebo|Inhaled placebo
15923115|NCT03473210|Drug|Antibiotics|ampicillin 2g IV every 6hours for 48 hours, followed by erythromycin 250mg every 6hours for 5days
15923116|NCT03473210|Drug|Corticosteroid|dexamethasone 8mg intramuscular every 12hours for 48 hours i.e. in four divided doses
15923117|NCT03473210|Procedure|Amniopatch|a total of around 60-80 mL of platelets, 100-150 mL of FFP and 100-150 mL of amnioinfusion fluid was used throughout the procedure
15923118|NCT03473197|Drug|Diacerein 1% ointment|During the 3-week Induction Phase, diacerein 1% ointment and vehicle ointment were applied under fully occlusive patch conditions to two randomly assigned skin sites on the infrascapular region of the back twice each week for approximately 24 hours (±4 hours). After patch removal, one application site and an untreated control site was irradiated, and all sites were evaluated 24 hours, 48 hours, and 72 hours later. Following a rest period, during the Challenge Phase, the study products were applied to two naive sites once for approximately 24 hours (±4 hours). After patch removal, one application site and an untreated control site was irradiated, and all sites were evaluated 24 hours, 48 hours, and 72 hours later. A Re-Challenge was to be performed if a response observed during the Challenge Phase indicated photosensitization.
15923119|NCT03473184|Drug|Diacerein 1% ointment|Diacerein 1% ointment and vehicle ointment were applied on Day 1 at two randomly assigned skin sites on each side of the lower thoracic area of the back according to a randomization scheme. One side of the back was irradiated on Day 2, including an untreated irradiated control site, and the other side was to remain non-irradiated.
15923120|NCT03473171|Device|Nasal non-invasive ventilation with RAM cannula|Pediatric Pulmonary Team will be consulted on inpatient or outpatient patients that fail to wean from chronic respiratory support (CPAP, BiPAP, High flow Nasal Cannula) in whom long-term ventilation is considered. Pediatric Pulmonary Team, as a consultant, will consider patient history, physical examination, previous imaging and laboratories and previous attempts to wean from respiratory support and causes of failure to wean. The Pulmonary team will determine which patients would potentially benefit from use of NIV/RAM-NC for long-term respiratory support and will recommend initiation of NIV/RAM-NC.
15923121|NCT03473158|Device|Transvaginal ultrasound|using the 6.5mHz intra-cavitary probe (65EC10EA) of ultrasound machine DP-50 (Shenzhen Mindray Bio-Medical Electronics Co., Ltd., P.R.China) to determine the number, site, size and cardiac activity of the fetuses, and monitor the fetal reduction procedure
15923122|NCT03473158|Procedure|Mechanical fetal reduction|under transvaginal ultrasound guidance, fetal reduction will be achieved by mechanical disruption of the fetal heart till asystole is achieved, and may be aided by partial or total suction of the fetus, using suction device attached to the embryo reduction needle (Cook® Ireland Ltd., Limerick, Ireland)
15923123|NCT03473158|Procedure|Chemical fetal reduction|under transvaginal ultrasound guidance, fetal reduction will be achieved by injecting 0.5 mL of potassium chloride (Potassium Chloride® 15% , EIPICO, Egypt) into the cardiac region through the embryo reduction needle (Cook® Ireland Ltd., Limerick, Ireland)
15923124|NCT03473145|Behavioral|Health Coaching|Health Coaching sessions will be aimed at goal setting, implementing strategies, overcoming barriers, & relapse prevention.
15923125|NCT03473145|Device|activPAL inclinometer|Participants in the intervention study arms (B & C) will wear the ActivPAL device for the first 4 weeks of the program and then again in weeks 8 and 9. The device will monitor their sitting and standing time and will allow Health Coaches to provide feedback and will assist the participant in developing an action plan.
15923126|NCT03473145|Other|Tools to Prompt Standing or Prompt Sit-to-Stand Transitions.|Participants in the intervention study arms (B & C) will receive tools to prompt standing or sit-to-stand transitions such as wearable wrist devices, standing desks or tables (Group B only), mechanical and/or electronic timers, or access to mobile apps or computer programs.
15923127|NCT03473132|Drug|four factor prothrombin complex concentrate|After treatment with 4F-PCC, coagulation factor levels will be assessed. Time to return to anticoagulation target INR will also be determined.
15923128|NCT03473106|Device|Pneumatic tourniquet use|Surgery requiring a pneumatic tourniquet on the thigh
15923129|NCT03473093|Drug|Pregabalin 150mg|One group will receive oral pregabalin with morphine infusion
15923130|NCT03473093|Drug|Morphine|One group will receive morphine infusion 20 microgram/kg/h
15924158|NCT03465280|Procedure|Carbon dioxide laser|Removal of lesions via carbon dioxide laser
15923131|NCT03473080|Behavioral|Internet CBT|The treatment consists of a standard cognitive behavior therapy for OCD with additional treatment components to make the treatment better suited for children and adolescents with Autism Spectrum Disorder.
15923132|NCT03473067|Behavioral|Social Norms Marketing Campaign|This poster based marketing campaign is designed to correct inaccurate perceptions of norms regarding violence.
15923133|NCT03473067|Other|Capacity Building|Schools will participate in teacher training and parent training.
15923134|NCT03473054|Other|Web-based Mindfulness Course|"The intervention is a therapist led, web-based MBI course, delivered asynchronously via a series of online videos. The Be Mindful course is a four-week mindfulness course based on the Mindfulness-Based Stress Reduction and Mindfulness-Based Cognitive Therapy courses. The course has been positively evaluated and shown to reduce stress, anxiety, and depression for participants.
~Participants complete ten online interactive videos (30 minutes each), twelve daily practice assignments (with supportive emails), five audio downloads, and online tools for reviewing progress. The minimum time to complete the course is four weeks, but people can take longer if they wish and will still have access to the resources."
15923135|NCT03473041|Procedure|Hybrid sling|sling formed of surgeon tailored autologous rectus sheath and polypropylene arms
15923136|NCT03473041|Procedure|TVT-O|midurethral transobturator vaginal tape
15923137|NCT03473028|Procedure|transabdominal ultrasound guided embryo transfer|400 female with body mass index more than 30undergo transabdominal ultrasound guided embryo transfer
15923138|NCT03473028|Procedure|transvaginal ultrasound guided embryo transfer|400 female with body mass index more than 30 undergo transvaginal ultrasound guided embryo transfer
15923139|NCT03473015|Device|PICSO|The PICSO Impulse catheter is a 8F double lumen catheter with a 15.5x20mm long balloon at the distal end. The balloon inflates and deflates cyclically once deployed in the coronary sinus, leading to intermitted coronary sinus pressure increase. The catheter is connected to the console through two pneumatic tubes in which helium is shuttled to and from the balloon. In addition, the coronary sinus pressure is monitored through the center lumen of the catheter.
15923140|NCT03473002|Other|Placebo|0.9% Sodium Chloride
15923141|NCT03473002|Biological|SeVRSV Vaccine|Recombinant Sendai virus vectored respiratory syncytial virus (SeVRSV) vaccine. SeVRSV is a replication-competent Sendai virus that carries the RSV F gene produced by reverse genetics technology.
15923142|NCT03472989|Device|Radial extracorporeal shock wave|"Patients will receive treatment once a week for 3 weeks. Treatment will be administered by using the rESWT device named Swiss DolorClast (EMS). 2000 impulses are implied via the power hand piece to the area of max tenderness at the insertion of the plantar fascia, with a pressure of 1.5-3 bars depending on what the patient tolerates. The treatments will be given by a trained physiotherapist at our Department.
~Patients will also receive standardized information at baseline, and will get custom made foot orthosis."
15923143|NCT03472989|Device|Sham-radial extracorporeal shock wave|"Patients will receive the same treatment as the patients in the group receiving real shock waves, but no real shock waves are conducted. The probe is similar in design, sound and shape.
~Patients will also receive standardized information at baseline, and will get custom made foot orthosis."
15923144|NCT03472989|Behavioral|Standardized high-load exercise program|"Patients will be instructed to do 2 exercises: Unilateral heel raise and unilateral leg squat three times a week for 12 weeks. The patients will have a total of 8 sessions supervised by a physiotherapist at our Department.
~Patients will also receive standardized information at baseline, and will get custom made foot orthosis."
15923145|NCT03472989|Behavioral|Usual care|Patients will get standardized information as in the other three intervention groups with information on pathogenesis, etiology and prognosis, and they will get custom made foot orthosis
15923146|NCT03472976|Other|Aqueous Cream B.P.|Aqueous Cream B.P. will be used as the control cream. An equivalent of 250mg of the cream will be applied and rubbed into the skin until it vanishes, on the deltoid area 5-15 minutes prior to vaccine administration.
15923147|NCT03472976|Drug|Imiquimod|Aldara (imiquimod 5%) cream is an immune response modifier for topical administration. 250 mg of the cream, equivalent to 12.5 mg of imiquimod will be applied and rubbed into the skin until it vanishes, on the deltoid area 5-15 minutes prior to vaccine administration.
15923148|NCT03472976|Biological|Influenza Virus Vaccine, Monovalent A/H5N1 A/Vietnam/1203/04|Inactivated monovalent subvirion H5N1 vaccine containing hemagglutinin (HA) of A/Vietnam/1203/04
15923149|NCT03472963|Drug|Single dose of Genvoya® and a single 800 mg dose of Darunavir®|Men will be instructed to take Single dose of Genvoya® and a single 800 mg dose of Darunavir® per oral
15923150|NCT03472950|Drug|Ranolazine 500 MG|Ranolazine is an FDA approved drug for angina (ongoing chest pain or pressure that is felt when the heart does not get enough oxygen).
15923151|NCT03472950|Drug|Ranolazine 1000 MG|Ranolazine is an FDA approved drug for angina (ongoing chest pain or pressure that is felt when the heart does not get enough oxygen).
15923152|NCT03472937|Procedure|Transcervical Foley catheter placement for cervical ripening|Subjects will be randomized have cervical ripening with a transcervical Foley catheter in either the inpatient or outpatient setting.
15923153|NCT03472924|Device|Kinesiotaping|The application of Kinesio Tape® (kinesiotaping) according to the guidelines provided by the Kinesio Taping Association (Kase, K. 2016). A 5 cm width strip of Kinesio Tape® (Kinesio TEX Products, NKT-050, Japan) will be applied from origin (the head of the fibula) to insertion (the medial cuneiform and first metatarsal) of the peroneus longus in a longitudinal direction. The proximal anchors will be applied without tension, and the Kinesio Tape® placed on approximately 50% stretch before being applied over the peroneus longus and the distal anchor point.
15923154|NCT03472911|Other|minimum effective volume|The determination of MEV50 and its 95% confidence interval (CI) was based on the staircase up-and-down method by Dixon and Massey.
15923155|NCT03472885|Drug|Danicopan|Participants received a daily oral dose of danicopan TID during the treatment period.
15923156|NCT03472885|Drug|Eculizumab|Participants received intravenous eculizumab administered at the participant's usual dose and schedule.
15923157|NCT03472872|Drug|Ketorolac|15mg ketorolac in 100mL 0.9% normal saline IVPB 1,000mg acetaminophen in a 100ml IVPB
15923158|NCT03472872|Drug|Acetaminophen|1,000mg acetaminophen IVPB
15923159|NCT03472859|Device|PHOTOLASE|This is the investigational yellow laser (PHOTOLASE)
15923160|NCT03472859|Device|KTP|This is the traditional green laser (KTP)
15923161|NCT03472846|Drug|Prolia, 60 Mg/mL Subcutaneous Solution|antiresorptive treatment with Prolia
15923166|NCT03472820|Other|Lifestyle Recommendations|Participants are encouraged to average a minimum of 7 hours of sleep per night.
15923167|NCT03472820|Other|Exercise Recommendations|Participants will be encouraged to exercise a minimum of 30 minutes at least 5 days per week at an intensity of 60-80% of maximum perceived exertion.
15923168|NCT03472820|Other|Stress Management Recommendations|Participants will utilize the Cleveland Clinic's Stress Free Now application to engage in a variety of guided stress reduction techniques, including meditation and mindful breathing. Recommended frequency is twice daily, preferably morning and evening.
15923169|NCT03472820|Other|PhytoGanix (tropical fruit flavor)|Organic Superfruits & Greens Powder Drink Mix is a food-based phytonutrient blend. Participants will take 2 servings daily in divided doses.
15923170|NCT03472820|Other|UltraFlora Intensive Care|Probiotic; Participants will take 2 capsules of UltraFlora Intensive Care probiotic daily in divided doses.
15923171|NCT03472807|Other|Collection of blood sample or saliva|at Inclusion
15923172|NCT03472807|Other|Collection of a tumor sample taken before the participation of the patient in study|at Inclusion
15923173|NCT03472807|Other|Collection of blood sample if tumor sample is not available|at Inclusion
15923174|NCT03472794|Other|"web portal:  Mon réseau cancer du sein  (My Breast cancer Network)"|"web portal:  Mon réseau cancer du sein "
15923175|NCT03472781|Other|No intervention. A retrospective case review|No intervention. A retrospective case review on demographics, etiology, clinical features, diagnosis, secondary complications, treatment and outcomes of intraocular inflammation in children aged 16 years and below that presented to uveitis clinic in Singapore National Eye Centre from January 1989 to January 2017.
15923176|NCT03472768|Diagnostic Test|Plasma Haptoglobin Concentration|N/A, comparison of haptoglobin concentration between groups
15923177|NCT03472755|Other|The posterolateral approach|The posterolateral approach was used for implantation among patients in lateral position. This approach goes through the gluteus maximus, the piriformis and superior gemeli muscles are detached and later reattached to bone
15923178|NCT03472755|Other|Direct anterior technique|patients were fixed in a supine position, a small entry incision was made in the vessel free interval between the tensor fasciae latae and the sartorius muscles and the prosthesis socket were put in place. Via a second dorsal incision, after releasing the external rotators, the prosthesis stem and ball were implanted and the two parts of the prosthesis were attached
15923179|NCT03472742|Drug|Mesenchymal Stem Cell|As this is a follow-up and an observation study, ADR-001 was administered in the previous study, not in this study.
15923180|NCT03472729|Other|AGE-ON Workshop|Series of workshops to reduce social isolation through technology use.
15923181|NCT03472716|Procedure|Biological Samples|"5 ml blood sample and one tumoural sample (either a fresh biopsy or the initial diagnosis biopsy).
~In case of relapse, new samples will be performed (blood and tumoral samples)"
15923182|NCT03472703|Other|Break-Lunch time|The time for the break and lunch will be contrary, depending on their visit/session
15923183|NCT03472690|Biological|QBECO-SSI|Subcutaneous injection
15923184|NCT03472690|Other|Placebo|Subcutaneous injection
15923185|NCT03472677|Other|Ice Pack and Cooling Device|A comparison of two cooling methodologies in healthy volunteers after single intra-articular (IA) injection (15 mL) of 2% lidocaine (without epinephrine).
15923186|NCT03472677|Drug|CNTX-4975-05 (trans-capsaicin)|Controlled cooling wrap vs ice pack cooling after single IA injection of 1 mg CNTX-4975-05 in each arm after single IA (15 mL) injection of 2% lidocaine (without epinephrine).
15923187|NCT03472677|Drug|CNTX-4975-05 (trans-capsaicin)|Controlled cooling parameters will be determined after evaluation of data from prior Cohort(s) after single IA injection (15 mL) of 2% lidocaine (without epinephrine) and single IA injection of 1 mg CNTX-4975-05.
15923188|NCT03472677|Drug|CNTX-4975-05 (trans-capsaicin)|Controlled cooling with knee device vs no cooling (determined after evaluation of data from previous cohorts) after single IA injection (15 mL) of 2% lidocaine (without epinephrine) and single IA injection of 1 mg CNTX-4975-05.
15923189|NCT03472677|Drug|Capsaicin|Four intradermal injections of capsaicin, two on each forearm.
15923190|NCT03472664|Other|low carbohydrate/high fat diet|Modified Mediterranean-Ketogenic Diet is a low carbohydrate/high fat diet.
15923191|NCT03472664|Other|low fat/high carbohydrate diet|American Heart Association Diet is a low fat/high carbohydrate diet.
15923192|NCT03472651|Drug|test treatment: flupentixol/melitracen|0.5 mg flupentixol and 10 mg melitracen, film-coated tablet, single dose
15923193|NCT03472651|Drug|reference treatment: flupentixol/melitracen|0.5 mg flupentixol and 10 mg melitracen, coated tablet, single dose
15923194|NCT03472638|Device|Dorsomedial prefrontal rTMS|Active or sham rTMS targeting the dorsomedial prefrontal cortex, 20 Hz stimulation, 120% resting motor threshold, 1500 pulses per hemisphere, using a MagVenture R30 stimulator and Cool-DB80 coil.
15923195|NCT03472625|Diagnostic Test|Screening and diagnosis of aphasia, dysarthria, dysphagia|"Screening (day 2 +/- 1; day 7 +/-1): NIHSS (National Health Institute Scale) 9 and 10 scores, dysphagia screening (nurse), speech-, and language screening (speech therapist)
~Diagnostic assessment (day 2 +/-1-):
~Dysphagia: MASA (Mann Assessment of Swallowing Abilities), FOIS (Functional Oral Intake Scale) Dysarthria: perceptual assessment, NSVO-Z (Nederlands spraakverstaanbaarheidsonderzoek - zinnen) Aphasia: ScreeLing, BNT (Boston Naming Test)"
15923196|NCT03472612|Other|CPAP withdrawal|Short-term withdrawal of CPAP therapy in moderate to severe OSA
15923201|NCT03472573|Drug|Palbociclib|Given PO
15923202|NCT03472573|Drug|Dexamethasone|Given PO
15923203|NCT03472560|Drug|Avelumab (MSB0010718C)|IV treatment: Avelumab administered at 800 mg IV every two weeks
15923204|NCT03472560|Drug|Axitinib (AG-013736)|Oral treatment: Axitinib given 5 mg PO BID
15924159|NCT03465280|Procedure|Potassium titanyl phosphate (KTP) laser|Removal of lesions via KTP laser
15923205|NCT03472547|Drug|diacerein 1% ointment|All subjects were exposed to diacerein 1% ointment, vehicle ointment, and 0.9% saline (negative control) at 3 randomly assigned, adjacent skin sites on the infrascapular area of the back 3 times weekly for 3 weeks (9 applications) during the Induction Phase, and one time during the Challenge Phase (10 times in total).
15923206|NCT03472534|Drug|diacerein 1% ointment|diacerein 1% ointment applied to the skin of the infrascapular area of the back under occlusive patch for 21 days.
15923207|NCT03472521|Drug|Gabapentin|Treatment with analgesic adjutant commonly used for post-operative pain, titrated to effect by chronic pain specialist compared to placebo titration.
15923208|NCT03472521|Drug|Placebo|Placebo to match gabapentin
15923209|NCT03472508|Drug|Folic Acid|Folic acid used in this study are listed products. All drugs used in the double-blind treatment period of this study will be loaded into safety capsules with the same outer appearance; all parties involved in the trial will be unaware of the contents of the capsules.
15923210|NCT03472508|Drug|Enalapril Maleate and Folic Acid Tablets (Yiye)|Enalapril Maleate and Folic Acid Tablets (Yiye) have been approved for listing by the China Food and Drug Administration. Approval number: Zhunzi H20103723.All drugs used in the double-blind treatment period of this study will be loaded into safety capsules with the same outer appearance; all parties involved in the trial will be unaware of the contents of the capsules.
15923211|NCT03472508|Drug|Enalapril|Enalapril used in this study are listed products. All drugs used in the double-blind treatment period of this study will be loaded into safety capsules with the same outer appearance; all parties involved in the trial will be unaware of the contents of the capsules.
15923212|NCT03472495|Drug|Diltiazem Oral Product|Diltiazem Immediate Release 60 MG PO Q6H (30 MG PO Q6H if patient is <60 kg)
15923213|NCT03472495|Drug|Diltiazem Injectable Product|Diltiazem Continuous Infusion Titrated
15923214|NCT03472482|Diagnostic Test|non-invasive retinal imaging|
15923215|NCT03472469|Drug|Acetaminophen IV/PO|Acetaminophen 1g IV/PO every 6 hours
15923216|NCT03472469|Drug|Acetaminophen PO|Acetaminophen 1g PO every 6 hours
15923217|NCT03472469|Drug|Ketorolac|Ketorolac 30mg IV once
15923218|NCT03472469|Drug|Celebrex|Celebrex 200mg PO every 12 hours
15923219|NCT03472469|Drug|Naproxen|Naproxen 500mg PO every 12 hours
15923220|NCT03472469|Drug|Tramadol|Tramadol 100mg PO every 6 hours
15923221|NCT03472469|Drug|Pregabalin|Pregabalin 100mg PO every 8 hours
15923222|NCT03472469|Drug|Gabapentin|Gabapentin 300mg PO every 8 hours
15923223|NCT03472469|Drug|Lidocaine|Lidocaine patch every 12 hours
15923224|NCT03472469|Drug|Opioids|Opioid options include: Oral Opioids (Codeine, Tramadol, Hydrocodone, Oxycodone, Methadone, Morphine, Hydromorphone); Transdermal Opioid (Fentanyl); Intravenous Opioids (Morphine, Hydromorphone, Fentanyl)
15923225|NCT03472469|Drug|Regional anesthesia|Regional anesthesia
15923226|NCT03472456|Drug|Implementation of a pulp medication in compliance with the dental emergency management protocol: articaïne|Implementation of a pulp medication in compliance with the dental emergency management protocol: articaïne
15923227|NCT03472456|Drug|Implementation of a pulp medication in compliance with the dental emergency management protocol: eugenol|Implementation of a pulp medication in compliance with the dental emergency management protocol: eugenol
15923228|NCT03472443|Other|acupuncture|Subjects will receive Sinew Acupuncture 2-3 times in two weeks, a total of 5 sessions. Needles will be inserted into the Sinew Acupoints on the affected wrist and forearm. Needles will be inserted along the subcutaneous level, nearly parallel to the skin, and the tip of needles pointing towards the painful spot at the radial styloid. 4-6 sinew acupoints will be used.
15923229|NCT03472430|Device|Transcutaneous electrical nerve stimulation|The TENS machine used in the study will be the Endomed 482 that delivers biphasic pulsed currents using pulse duration of 400 µs and pulse frequencies between 80-100 pulses.
15923230|NCT03472430|Device|TENS machine with electrodes not emitting any impulses.|TENS machine with electrodes not emitting any impulses.
15923231|NCT03472417|Device|Active partial rebreathing device|
15923232|NCT03472417|Device|Dummy partial rebreathing device|
15923233|NCT03472404|Procedure|Internal Brace augmented ankle Ligament reconstruction|internal brace augmented ankle ligament reconstruction and an accelerated revalidation protocol.
15923234|NCT03472404|Procedure|Brostrom-Gould ankle Ligament reconstruction|Brostrom-Gould and standard revalidation including 6 weeks immobilisation.
15923235|NCT03472391|Behavioral|Physical Therapy|A 4-week (2 exercise session af week, of 40 minutes )tailored physiotherapeutic exercise program. The sessions are individually and supervised by physical therapist and tailored to patients with severe anorexia nervosa. The exercise program mainly consist of strength training exercises without any equipment other than a floor mat.
15923236|NCT03472378|Drug|DFN-15|Oral Solution of 4.8 mL containing 120 mg of DFN-15
15923237|NCT03472378|Other|Placebo|Oral Solution of 4.8 mL containing 0 mg of DFN-15
15923238|NCT03472365|Biological|SHR-1210|SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
15923239|NCT03472365|Drug|Capecitabine|1000 mg/m^2 administered as continuous oral twice daily (BID) of each 3-week cycle.
15923240|NCT03472365|Drug|Oxaliplatin|130 mg/m^2 administered IV Q3W on Day 1 of each 3-week cycle.
15923241|NCT03472365|Drug|Apatinib|375 mg administered as continuous oral once daily (QD) of each 3-week cycle.
15923242|NCT03472352|Biological|An anticancer medication (A01) and immune cells (IC01)|The administration of A01 and IC01 will be performed in the Second People's Hospital of Yibin, Sichuan, China. The subjects will be observed for any side effects during this time and all the adverse events will be recorded.
15923243|NCT03472339|Drug|Diclofenac Sodium|Group A-Intramuscular diclofenac sodium+oral placebo Group B-Oral diclofenac sodium+ intramuscular placebo
15923244|NCT03472326|Drug|GS-9131|Tablet(s) administered orally once daily
15923245|NCT03472326|Drug|BIC|Tablet(s) administered orally once daily
15923246|NCT03472326|Drug|TAF|Tablet(s) administered orally once daily
15923247|NCT03472326|Drug|ARV regimen|ARV regimen may consist of the ARV agents containing nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) and non-nucleoside reverse transcriptase inhibitor (NNRTI)
15923248|NCT03472326|Drug|DRV|Tablet(s) administered orally once daily
15923249|NCT03472326|Drug|RTV|Tablet(s) administered orally once daily
15924160|NCT03465280|Procedure|Pulsed dye laser|Removal of lesions via pulsed dye laser
15923250|NCT03472313|Drug|[18F]MNI-958|Healthy Volunteers recruited for the study will undergo a single [18F]MNI-958 injection and PET scan.
15923251|NCT03472300|Other|Survey about knee pain and treatment|All citizens are surveyed to describe the prevalence of knee pain in a danish community.
15923252|NCT03472287|Drug|Diacerein 1% Ointment|Diacerein 1% Ointment administered topically
15923253|NCT03472274|Drug|Durvalumab|Durvalumab 1500 mg every 4 weeks x 3 cycles
15923254|NCT03472274|Drug|Tremelimumab|Tremelimumab 75 mg every 4 weeks x 3 cycles
15923255|NCT03472274|Drug|Cisplatin-based neoadjuvant chemotherapy|"Regimen 1: 21-day treatment cycle x 3 cycles.
~Gemcitabine 1,000-1,200 mg/m2 intravenously on days 1 and 8 every 21 days.
~Cisplatin 70 mg/m2 intravenously on day 1 every 21 days. Regimen 2: ddMVAC 14-day treatment cycle x 4 doses.
~Methotrexate 30mg/m2 intravenously on day 1
~Vinblastine 3mg/m2 intravenously on day 2
~Doxorubicin 30mg/m2 intravenously on day 2
~Cisplatin 70mg/m2 intravenously on day 2 Granulocyte colony-stimulating factor (G-CSF) for 7 consecutive days (days 4 through 10).
~Regimen 3: 21-day treatment cycle x 3 cycle
~Gemcitabine 1,000 mg/m2 intravenously on day 1 and 8
~Paclitaxel 80 mg/m2 intravenously on day 1 and 8
~Cisplatin 70mg/m2 intravenously on day 1"
15923256|NCT03472261|Drug|Botulinum toxin type A|Dysport
15923257|NCT03472261|Other|Upper extremity orthoses|Twister
15923258|NCT03472261|Other|Home exercise program|Specific exercises for pronation deformity
15923259|NCT03472248|Behavioral|Acceptance and Commitment Therapy|Eight weeks of smartphone delivered Acceptance and Commitment Therapy for the adolescent and eight weeks of internet delivered parental support to one or two parents of the adolescent.
15923260|NCT03472235|Device|Microneedle|"TCA peeling session: Facial skin will be cleansed with tap water and degreased by rubbing with an alcohol sponge .
~Then TCA 25% will be applied to the whole face by cotton tipped applicator or gauze pad. The entire face will be treated until complete frosting occur.
~The patients will be instructed to wash their faces to decrease the burning sensation.
~Combined session: starts with microneedle using microneedle device (Derma pen) The skin of each patient is cleaned with anti septic solution and anesthetic cream may be applied to lessen discomfort.
~(Dermapen) will be applied on the lesional skin in four direction, vertical, horizontal and in the two diagonal until pin point bleeding occur which will be gently massaged .
~After 10 minutes TCA peeling will be applied TCA peeling will be done for 8 session with 2 weeks interval between each session.
~Microneedle will be done for 4session with 4 weeks interval between each session."
15923261|NCT03472222|Behavioral|Arsha Vidya program|Integrated intervention program includes counselling and supportive care with the support of Arsha Vidya program
15923262|NCT03472196|Device|EndoZip System|"The Nitinotes EndoZip system is designed to allow for the creation of multiple internal gastric segmentation (4-8) in the stomach by using an endoscopic approach. The system allows the forming of wall-to-wall longitudinal attachments of the anterior and posterior stomach walls, creating multiple strictures within.
~Creation of this segmentation may significantly reduce gastric volume, may affect gastric motility and consequently, reduce weight."
15923263|NCT03472183|Other|biopsies of colon|Removal of additional biopsies of colon during the course of a colonoscopy planned for usual medical follow-up of patient
15923264|NCT03472170|Dietary Supplement|Enteral administration of bovine lactoferrin (bLf)|The pharmacy service of the hospital will provide the established dose of lactoferrin, according to the regimen of administration of 150 mg / kg / day (maximum 300 mg / day), as well as that of placebo. Both treatments will be administered in liquid form, in the least amount possible. Both the administration of lactoferrin and placebo will be carried out enterally, orally or by nasogastric tube. The intervention will be done in the first 72 hours of life, once a day, and for 4 weeks, extending to 6 weeks in the newborns with EG ≤ 28 weeks and / or birth weight ≤ 1000 gr, or until discharge if this happens before.
15923265|NCT03472170|Other|Enteral administration of placebo|Enteral administration of placebo with similar visual and gustatory characteristics in the first 72 hours of life, and for 4 weeks (6 weeks in the RN ≤ 1000 gr and / or EG ≤ 28 weeks).
15923266|NCT03472157|Other|Lifestyle therapy|Lifestyle habits (caloric intake and exercise) + pedometer
15923267|NCT03472157|Procedure|Bariatric surgery|Two different types of bariatric surgery can be proposed: laparoscopic Roux-en-Y Gastric Bypass or a Laparoscopic sleeve gastrectomy
15923268|NCT03472144|Drug|gel loaded with steroids (momentasone)|One of the purpose of this study is to evaluate the efficacy of a gel that actively releases local corticosteroids (momentasone) after balloon sinuplasty for chronic sinusitis patients.
15923269|NCT03472144|Drug|gel loaded with antibiotic (Levofloxacin)|One of the purpose of this study is to evaluate the efficacy of a gel that actively releases local antibiotic(levofloxacin) after balloon sinuplasty for chronic sinusitis patients.
15923270|NCT03472144|Drug|gel loaded with both steroids and antibiotic|One of the purpose of this study is to evaluate the efficacy of a gel that actively releases local both steroids (momentasone)and antibiotic(levofloxacin) after balloon sinuplasty for chronic sinusitis patients.
15923271|NCT03472131|Procedure|Unilateral Posterolateral Approach and Debridement|
15923272|NCT03472131|Other|Titanium cage insertion supplemented by screw fixation|
15923273|NCT03472118|Device|Nasal High Flow Oxygen|Nasal High Flow Oxygen during apnoea using Optiflow device of Fisher and Paykel
15923274|NCT03472105|Dietary Supplement|New Nordic Renal Diet|One week ingesting a phosphorus reduced diet containing a total of 850 mg of phosphorus/day compared to one week of a habitual diet
15923275|NCT03472092|Behavioral|Cognitive Behavioral Therapy (CBT)|This intervention will consist of 8 weekly sessions. The duration of each session is about 45 minutes and will be led by a psychologist/therapist using a manualized protocol. About half of the sessions will be conducted in person and the remaining sessions will be offered via telehealth (Skype or phone).
15923276|NCT03472092|Drug|Placebo|The placebo pill will be administered once a day at home for 8 weeks, to be taken by mouth with or without food under the supervision of the participant's parent or guardian. To maintain blinding, all participants will receive 1 matching capsule as a daily dose to be taken each evening during the study.
15923308|NCT03471858|Device|Cervical balloon|To assess if a cervical balloon catheter (foleys catheter) for mechanical induction of labour is comparable to prostaglandin usage for induction of labour in women who have had a previous caesarean section.
15923309|NCT03471858|Drug|Prostaglandins|Prostin will be used in the control arm.
15923449|NCT03470623|Device|bioabsorbable screws|Hallux valgus are treated with a distal chevron osteotomy of first metatarsal and fixed using the bioabsorbable screw
15923277|NCT03472092|Drug|Amitriptyline|Amitriptyline will be administered once a day at home for 8 weeks, to be taken by mouth with or without food under the supervision of the participant's parent or guardian. To maintain blinding, all participants will receive 1 matching capsule as a daily dose to be taken each evening during the study. For this study, a dose of 0.25 mg/kg/day will be provided for the 1st 2 weeks, followed by a dose of 0.5 mg/kg/day for 2 weeks, 0.75 mg/kg/day for 2 weeks and a maximum dose of 1.0 mg/kg/day for 2 weeks based on tolerability. Participants experiencing tolerability issues, may be held a current dose rather than titrated to the next dosage if deemed appropriate by the study doctor.
15923278|NCT03472092|Behavioral|Biofeedback-Assisted Relaxation Training (BART)|This intervention will consist of 8 weekly sessions. The duration of each session is about 45 minutes and will be led by a psychologist/therapist using a manualized protocol. About half of the sessions will be conducted in person and the remaining sessions will be offered via telehealth (Skype or phone).
15923279|NCT03472092|Behavioral|Cognitive Reappraisal Training (CR)|This intervention will consist of 8 weekly sessions. The duration of each session is about 45 minutes and will be led by a psychologist/therapist using a manualized protocol. About half of the sessions will be conducted in person and the remaining sessions will be offered via telehealth (Skype or phone).
15923280|NCT03472066|Other|Previous conization|a group of women who have been conized,
15923281|NCT03472066|Other|no previous conization|group with asymptomatic patients on routine second trimester echography
15923282|NCT03472053|Drug|BIO-11006 plus standard of care|BIO-11006 is administered 125mg BID plus standard of care.
15923283|NCT03472053|Drug|Standard of Care|Pemetrexed (500 mg/meter square) and Carboplatin (AUC6, Calvert's formula) are administered every three weeks for three months.
15923284|NCT03472040|Drug|BCX7353|BCX7353 mg oral capsules administered once daily
15923285|NCT03472027|Biological|BCD-145|Anti-CTLA-4 monoclonal antibody, IV infusion
15923286|NCT03472014|Biological|IMVAMUNE®|IMVAMUNE® liquid -frozen, containing 1 x 10E8 TCID50 MVA-BN® per 0.5 mL dose
15923287|NCT03472001|Other|Reflection and feedback|2-hour training involving 10 written clinical cases to encourage students to practice thinking like a dermatologist in their clinical reasoning, and to help students build adequate illness scripts of skin diseases
15923288|NCT03472001|Other|Lecture|Traditional didactic lecture which uses the same clinical cases
15923289|NCT03471988|Drug|AK1820|"Only a switch from IV infusion (vial) to oral administration (capsule) will be permitted; a switch from oral administration to IV infusion will not be possible.
~372.6 mg of AK1820 (isavuconazonium sulfate) is equivalent to 200 mg of isavuconazole.
~Other Names: Cresemba, BAL8557"
15923290|NCT03471988|Drug|Voriconazole|"Only a switch from IV infusion (vial) to oral administration (tablet) will be permitted; a switch from oral administration to IV infusion will not be possible.
~Other Name : VFend"
15923291|NCT03471975|Procedure|direct laryngoscope|the trainee use McGrath video laryngoscope as direct laryngoscope the trainee is not allowed to watch the screen.
15923292|NCT03471975|Procedure|video laryngoscope|the trainee use McGrath video laryngoscope both trainee and trainer can watch the screen.
15923293|NCT03471962|Other|surgery|Indirect measurement of RQ was performed by anesthesia ventilator and compared to marker of anaerobic metabolism (arterial lactate, venoarterial PCO2 gradient, venoarterial PCO2 gradient/ arteriovenous O2 content difference, ScVO2) at different time of the srugery (every hours). In post-operative time, complications and hospital's length of stay were recorded.
15923294|NCT03471949|Other|CGM in a population with normal OGTT|The population with normal OGTT will use CGM and document their values as well as be documenting a capillary blood glucose value
15923295|NCT03471936|Diagnostic Test|Acquisition of pressure-volume-loops|Diagnostic workup including cardiac MRI, Echocardiography and cardiopulmonary exercise test (CPET) followed by invasive acquisition of RV and left ventricular (LV) pressure-volume-loops
15923296|NCT03471923|Diagnostic Test|Neurological Examination|The family members and healthy volunteers will undergo elements of the neurological examination during which the movement disorders neurologist will look specifically for the presence of cervical dystonia and other sensory abnormalities. If the subject is found to have cervical dystonia or any other sensory abnormalities, the subject will be excluded from the study.
15923297|NCT03471923|Diagnostic Test|Assessment of Non-Motor Features|All subjects will be assessed for four non-motor symptoms, including (1) spatial discrimination threshold, (2) temporal discrimination threshold, (3) vibration-induced illusion of movement, and (4) kinesthesia.
15923298|NCT03471910|Drug|Diosmin|Diosmin 600mg tablet, once daily
15923299|NCT03471910|Drug|Diosmin / Hesperidin|Diosmin 900 mg / Hesperidin 100mg tablet, once daily
15923300|NCT03471897|Diagnostic Test|Glycosaminoglycan plasma score|A score was calculated using a formula that factors in measurements of plasma glycosaminoglycan. A score higher than a here-determined threshold is deemed diagnostic of RCC.
15923301|NCT03471884|Procedure|Nonintubated thoracoscopic lobectomy|Nonintubated general anesthesia using fentanyl, target-controlled infusion of propofol to achieve a bispectral index value between 40 and 60. One-lung ventilation will be achieved via a spontaneous breathing due to iatrogenic pneumothorax.
15923302|NCT03471884|Procedure|Intubated thoracoscopic lobectomy|Intubated general anesthesia using 2%-3% sevoflurane and rocuronium to achieve a bispectral index value between 40 and 60. One-lung ventilation will be achieved via a endobronchial tube or blocker with use of mechanical ventilation.
15923303|NCT03471871|Drug|Placebo|HV: Lemborexant-matched oral placebo will be administered at bedtime in the clinic (within 5 minutes of lights off).
15923304|NCT03471871|Drug|Lemborexant 10 mg|HV: 10 mg oral lemborexant will be administered at bedtime in the clinic (within 5 minutes of lights off).
15923305|NCT03471871|Drug|Lemborexant 25 mg|HV: 25 mg oral lemborexant will be administered at bedtime in the clinic (within 5 minutes of lights off).
15923306|NCT03471871|Drug|Placebo|OSA: Lemborexant-matched oral placebo will be administered at bedtime in the clinic (within 5 minutes of lights off) in the evening of Days 1 and 8. On Days 2 to 7, participants will take study drug at home, immediately (within 5 minutes) of the time they intend to try to sleep.
15923307|NCT03471871|Drug|Lemborexant 10 mg|OSA: 10 mg oral lemborexant will be administered at bedtime in the clinic (within 5 minutes of lights off) in the evening of Days 1 and 8. On Days 2 to 7, participants will take study drug at home, immediately (within 5 minutes) of the time they intend to try to sleep.
15923658|NCT03468985|Other|Laboratory Biomarker Analysis|Correlative studies
15923310|NCT03471845|Device|Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System|Treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements
15923311|NCT03471832|Device|stenfilcon A lens|contact lens
15923312|NCT03471832|Device|narafilcon A lens|contact lens
15923313|NCT03471819|Diagnostic Test|Serum serotonin level|blood sample will be obtained to evaluate serum level of serotonin
15923314|NCT03471806|Behavioral|Food reward at baseline|Exposure to a combination of anticipatory (viewing high-calorie food images) and consummatory food reward (drinking sips of chocolate milkshake), at baseline.
15923315|NCT03471806|Behavioral|Food reward after treatment|Exposure to a combination of anticipatory (viewing high-calorie food images) and consummatory food reward (drinking sips of chocolate milkshake), at the end of inpatient treatment.
15923316|NCT03471780|Diagnostic Test|ultrasound|Transperineal us are made to pregnant ladies in labour
15923317|NCT03471767|Drug|AXS-05|Dextromethorphan Immediate Release + Bupropion Sustained Release: Take 1 tablet two times per day, at least 8 hours apart and 1 hour prior to a meal, and 2 hours after a meal.
15923318|NCT03471767|Drug|Bupropion SR|Bupropion Sustained Release: Take 1 tablet two times per day, at least 8 hours apart and 1 hour prior to a meal, and 2 hours after a meal.
15923319|NCT03471754|Device|TESA-HB Transcranial Electronic Stimulation Device|Duration of treatment: 50 Minute Therapy sessions administered one time each day, for two 5-day cycles
15923320|NCT03471741|Radiation|IMRT with concomitant boost|
15923321|NCT03471741|Radiation|3D-RT with sequential boost|
15923322|NCT03471728|Drug|linaclotide|Oral
15923323|NCT03471702|Device|Smart External Drain - SED|Aqueduct's Smart External Drain (SED) is a gravity based system which utilizes a proprietary reference shroud which eliminates the need for manual adjustment of the system in the external management of CSF drainage.
15923324|NCT03471689|Behavioral|Mindfulness meditation|Participants will be trained to use mindfulness meditation to reduce pain perception.
15923325|NCT03471689|Behavioral|Positive reappraisal|Participants will be trained to use positive reappraisal to reduce pain perception.
15923326|NCT03471676|Other|Muscular oximetry|6 minutes walking test performed in the routine medical care with muscle oximetry recording
15923327|NCT03471663|Drug|D-0502|oral tablets
15923328|NCT03471663|Drug|palbociclib|standard dose of palbociclib
15923329|NCT03471650|Drug|18F-DCFPyL Injection|A bolus of ~9 mCi (333 MBq) of 18F-DCFPyL will be injected by slow IV push.
15923330|NCT03471637|Other|Compassion-Focused Therapy|"Compassion-Focused Therapy 11 weeks of Compassion-Focused Therapy [based on Compassion-Focused Therapy for Dummies (Welford, 2016)]"
15923331|NCT03471624|Drug|Tenofovir Alafenamide|Tenofovir alafenamide (TAF) is a new formulation of tenofovir with higher intracellular active drug concentration allowing for dosing of only 25 mg once daily and thus can potentially lower the already low risk of renal toxicity and bone loss with tenofovir disoproxil fumarate (TDF).
15923332|NCT03471611|Drug|Autologous CD34+ Cells|The dose will be 1x10^5 cells/kg, injected at the rate of 10 ml/min
15923333|NCT03471611|Drug|Granulocyte Colony-Stimulating Factor (G-CSF)|5mg/kg twice daily
15923334|NCT03471585|Drug|THC|A capsule that contains 15 mg of THC as well as dextrose filler administered 2 hours prior to memory testing.
15923335|NCT03471585|Drug|Placebo oral capsule|A capsule that contains only dextrose filler administered 2 hours prior to memory testing.
15923336|NCT03471559|Drug|Cannabidiol|single or multiple dosing
15923337|NCT03471546|Behavioral|Palliative Care|Initial consultation and follow-up with a palliative care provider
15923338|NCT03471533|Dietary Supplement|nutraceutical: experimental product|84 days of consumption
15923339|NCT03471533|Dietary Supplement|placebo|84 days of consumption
15923340|NCT03471520|Behavioral|Earplugs and eye masks|Patients in this study will be given earplugs and eye masks to be worn during sleep
15923341|NCT03471507|Drug|Bonipar|Apply 2 pumps 2 times a day to be applied topically on the affected area during a two week treatment period.
15923342|NCT03471507|Drug|Diclofenac sodium topical solution 1.5%|Apply 2 pumps 2 times a day to be applied topically on the affected area during a two week treatment period.
15923343|NCT03471494|Other|Exposure: human development index of country|Primary comparison: Between country groups defined by human development index.
15923344|NCT03471481|Other|No Intervention. Study is Cross Sectional in nature|No Intervention. Study is cross sectional in nature
15923345|NCT03471468|Procedure|kinetics of microparticles under chemotherapy|Blood samples done before chemotherapy and 6 hours later for each of six chemotherapies required by the protocol.
15923346|NCT03471455|Drug|Isotretinoin|Patients of recurrent dermatophytosis will receive terbinafine or itraconazole , either alone or in combination with oral isotretinoin
15923347|NCT03471455|Drug|Terbinafine|Patients of recurrent dermatophytosis will receive terbinafine or itraconazole , either alone or in combination with oral isotretinoin
15923348|NCT03471455|Drug|Itraconazole 200 mg|Patients of recurrent dermatophytosis will receive terbinafine or itraconazole , either alone or in combination with oral isotretinoin
15923349|NCT03471442|Procedure|Paravertebral block|Ultrasound-guided paravertebral block performed pre-operatively in the anesthesia block room with 20ml of a ropivacaine / bupivacaine mixture.
15923350|NCT03471442|Procedure|Erector spinae plane block|Ultrasound-guided erector spinae plane block performed pre-operatively in the anesthesia block room with 20ml of a ropivacaine / bupivacaine mixture.
15923351|NCT03471442|Drug|General anesthetic|General anesthesia administered as per preference of intra-operative attending anesthesiologist
15923352|NCT03471442|Drug|Opioids|Intra-operatively, opioids will be titrated to heart rate and spontaneous respiration rate e.g. fentanyl, morphine, hydromorphone. Post-operatively in post anesthesia care unit, morphine and hydromorphone will be titrated to effect as necessary. After discharge from post anesthesia care unit, oral analgesia will be administered on an as required basis e.g. acetaminophen, non-steroid anti-inflammatory medications, acetaminophen / codeine and acetaminophen / oxycodone.
15923353|NCT03471442|Drug|Anesthetics, Local|Weight-based dosing of this local anesthetic mixture.
15923354|NCT03471390|Other|ProQuaS 2 Intervention|Training and implementation of facility pain champions, comprehensive training of all care workers in pain assessment and management, implementation of pain management policies
15923355|NCT03471377|Other|standard scheduling process|Scheduling office assigns start time and room for case and places case on schedule. At this point a default case duration is evaluated by the scheduling office, to see if the value is considered excessively short or excessively long. Depending on the assessment, the scheduling office will either keep the default value, use the value that the surgeon placed in the notes (if available), or the scheduling office provides their own estimation.
15923356|NCT03471377|Other|assigned a planned case duration value from predictive model|"Predictive model calculates new duration for case at 3AM the day before surgery, and the predictions are made available on a SecureShare-site.
~Model predictions are then read by scheduling manager sometime between 7am-10am from the SecureShare site, and the scheduling manager will in EPIC/OpTime, overwrite the current estimate with the new duration value that was generated by the predictive model."
15923357|NCT03471364|Drug|Ketoconazole|Applied topically
15923358|NCT03471364|Other|Laboratory Biomarker Analysis|Correlative studies
15923359|NCT03471364|Other|Placebo|Applied topically
15923360|NCT03471364|Other|Quality-of-Life Assessment|Ancillary studies
15923361|NCT03471364|Other|Questionnaire Administration|Ancillary studies
15923362|NCT03471351|Drug|Tenalisib|Tenalisib, BID, orally and Pembrolizumab 200 mg IV Q3W
15923363|NCT03471351|Biological|Pembrolizumab|Tenalisib, BID, orally and Pembrolizumab 200 mg IV Q3W
15923364|NCT03471338|Behavioral|Cognitive rehabilitation|"At-site inclusion visit: assessment of patient's eligibility by cognitive complaint questionnaire and BCcogSEP, VAPS and multiple errands test conducted by neuropsychologist.
~At-site baseline visit: assessment of quality of life (MUSIQOL), self-esteem (SEI), depression (MADRS), anxiety (HAMA), BICAMS: SDMT, CVLT-II, BVMTR, metacognition (MCQ-30), fatigue (EMIF-SEP), subjective sleep quality (PSQI) conducted by a neuropsychologist.
~At-home neuropsychological management (9 weeks): The patient performs the program (PRESCO software) on his computer autonomously at home at a rate of 3 sessions per week. A neuropsychologist performs at-home visits and weekly phone meetings to train the patient to the software, to encourage him to do exercises and to answer any software use-related questions.
~At-site follow-up visits: short and long-term retest of assessments performed in inclusion visit."
15923365|NCT03471338|Behavioral|Standard Psychological care|"At-site inclusion visit: assessment of patient's eligibility by cognitive complaint questionnaire and BCcogSEP, VAPS and multiple errands test conducted by neuropsychologist.
~At-site baseline visit: assessment of quality of life (MUSIQOL), self-esteem (SEI), depression (MADRS), anxiety (HAMA), BICAMS: SDMT, CVLT-II, BVMTR, metacognition (MCQ-30), fatigue (EMIF-SEP), subjective sleep quality (PSQI) conducted by a neuropsychologist.
~At-home neuropsychological management (9 weeks): A neuropsychologist performs at-home visits and weekly phone meetings consisting in discussion of the patient's cognitive disorders.
~At-site follow-up visits: short and long-term retest of assessments performed in inclusion visit."
15923366|NCT03471325|Procedure|Plaque disclosed with air flow|air polishing with prior plaque disclosing
15923367|NCT03471325|Procedure|Plaque disclosed with rubber cup|rubber cup polishing with prior plaque disclosing
15923368|NCT03471325|Procedure|Non plaque disclosed air flow|air polishing with no prior plaque disclosing
15923369|NCT03471325|Procedure|Non plaque disclosed rubber cup|rubber cup polishing with no prior plaque disclosing
15923370|NCT03471312|Drug|Magnesium|magnesium therapy
15923371|NCT03471286|Drug|Epacadostat|Drug is taken orally two times per day for 14 days, prior to surgical resection of tumor.
15923372|NCT03471273|Procedure|endoscopic management, surgery and follow up|endoscopic management, surgery and follow up
15923373|NCT03471260|Drug|Azacitidine|Given IV or SC
15923374|NCT03471260|Drug|Ivosidenib|Given PO
15923375|NCT03471260|Drug|Venetoclax|Given PO
15923376|NCT03471247|Device|In-Bed Cycle Ergometer|Physiotherapists will place the patient's legs in a specialized in-bed cycle ergometer allowing for gentle leg exercise. Exercise can performed in passive, active-assisted, or active mode.
15923377|NCT03471247|Other|Routine PT|Includes, based on the patient's alertness and medical stability, activities to maintain or increase limb range of motion and strength, in- and out- of bed mobility, ambulation, and assistance with optimizing airway clearance and respiratory function.
15923378|NCT03471234|Device|Angioplasty|Inspiron Drug Eluting stent implantation
15923379|NCT03471221|Behavioral|Therapy Dog Visit|"Animal Assisted Activities (AAA) provide opportunities for motivational, educational, recreational, and/or therapeutic benefits to enhance quality of life. AAA are delivered in a variety of environments by specially trained professionals, paraprofessionals, and/or volunteers, in association with animals that meet specific criteria.
~Key features of AAA are as follows:
~Specific treatment goals are not planned for each visit.
~Volunteers and treatment providers are not required to take detailed notes.
~Visit content and activities are spontaneous.
~Visit length can be as long or as short as needed."
15923380|NCT03471208|Device|Dynamic Navigation Assisted Implant Surgery|Implant surgery using dynamic navigation assistance
15923381|NCT03471208|Procedure|Freehand Implant Surgery|Dental implant surgery via conventional freehand
15923382|NCT03471195|Diagnostic Test|Total Salivary Cytokine profile|Saliva will be collected using the passive drool technique and stored in a deep freezerat-60C.
15923383|NCT03471182|Behavioral|Psychiatric and Cognitive Testing|Interviews, questionnaires, and computer testing.
15923384|NCT03471182|Drug|Cocaine Self-adminstration|The intervention will include a training and safety session that consists of physician/nurse-administered cocaine followed by a self-regulated cocaine administration period under carefully controlled and closely monitored conditions.
15923385|NCT03471182|Radiation|Positron Emission Tomography|PET scans will be performed on a High Resolution Research Tomograph (HRRT), the highest resolution human brain scanner available. Antecubital venous catheters will be used for IV administration of the radiotracer and for venous blood sampling. A radial artery catheter may also be inserted by an experienced physician before the PET scan. At the beginning of each scan, the participants's head will be immobilized and a 6-minute transmission scan, using an orbiting 137Cs point-source, is obtained and used for attenuation correction. PET scans will be acquired using bolus or bolus plus constant infusion administration of [18F]FPEB.
15923445|NCT03470675|Drug|Epidural morphine 3 mg + IV ketamine 0.3 mg/kg|Morphine 3 milligrams injection in the epidural catheter and 0.3 milligrams per kilogram weight infused in the intravenous catheter
15923446|NCT03470662|Other|Care bundle|Care bundle
15923659|NCT03468985|Biological|Nivolumab|Given IV
15923386|NCT03471182|Other|Magnetic Resonance Imaging|Structural and functional MRI data will be acquired using a Siemens Trio TIM 3.0T system at the Yale Magnetic Resonance Research Center. High-resolution structural MRI data will be acquired to facilitate analysis of PET data and may be used in additional analysis of tissue volume and brain structure. Resting-state and task-based functional MRI data will be acquired using state-of-the-art multiband echo-planar imaging (EPI) gradient-echo sequences. Diffusion-weighted MRI data will also be acquired using multiband imaging sequences to investigate anatomical connectivity.
15923387|NCT03471169|Drug|Desirable TEG|"Change the type and dose of antithrombotic therapy and obtain desirable TEG results.
~Antithrombotic drugs inclued Bayaspirin®，Plavix ® and Cilostazol."
15923388|NCT03471169|Drug|Undesirable TEG|Don't change the type and dose of antithrombotic therapy and obtain undesirable TEG results. Antithrombotic drugs inclued Bayaspirin®，Plavix ® and Cilostazol.
15923389|NCT03471143|Drug|2-Hydroxypropyl-Beta-Cyclodextrin|"VTS-270 (2-Hydroxypropyl-Beta-Cyclodextrin) will be administered intravenously to specifically target liver disease. In the first phase of the study, dosing frequency will be twice a week with IV VTS-270 for six weeks for a total of 12 administrations. Subjects will be evaluated at each study visit for evidence of adverse effects.
~Doses to be studied are 500, and 1000 mg/kg. Six subjects will be studied at each dose level. Cohort 1: Subjects 1-6, 500 mg/kg Cohort 2: Subjects 7-12, 1000 mg/kg"
15923390|NCT03471130|Drug|MT-8554 Low dose|Oral, 7 days
15923391|NCT03471130|Drug|MT-8554 High dose|Oral, 7 days
15923392|NCT03471130|Drug|Placebo|Oral, 7 days
15923393|NCT03471117|Drug|Pioglitazone|Pioglitazone 15mg daily for 1 month
15923394|NCT03471117|Other|Placebo|Placebo pills for 1 month
15923395|NCT03471104|Other|PAID in clinical diabetes consultations|"The intervention starts when participants complete PROMs before an annual consultation. The physician reviews the PAID (problem areas in diabetes scale) scores with the participant. Participants with one or more single PAID item(s) scored 3 or 4, or a PAID score ≥30, will be referred to extra follow-up which will consist of at least two diabetes nurse consultations. The nurses will follow a communication manual based on key elements from empowerment theory and self-determination theory.
~The participants then complete the PROMs prior to the next annual consultation with the physician."
15923396|NCT03471091|Device|NIV with the integrated tele-monitoring management program|Noninvasive positive pressure ventilation with the integrated tele-monitoring management will provide regular health report, and once an alert is generated due to the abnormality in NIV usage or vital sign data etc., physicians will take action accordingly.
15923397|NCT03471078|Drug|Avatrombopag|Oral avatrombopag tablet
15923398|NCT03471078|Drug|Placebo Oral Tablet|Placebo comparator tablet
15923399|NCT03471065|Device|SAPIEN 3 Ultra Delivery System with the SAPIEN 3 Ultra THV|Patients will be implanted with the SAPIEN 3 Ultra THV (20, 23 and 26 mm) or SAPIEN 3 THV (29 mm) using the SAPIEN 3 Ultra Delivery System.
15923400|NCT03471052|Procedure|Radiofrequency ablation (RFA)|"Ablation using the Barrx RFA System is a new technique for field ablation in the oesophagus. It has been used for eradication of diseased epithelium of all three subclasses of Barrett's oesophagus (non-dysplastic Intestinal metaplasia (IM), Low grade dysplasia (LGD) and High grade dysplasia (HGD). The BarrxTM RFA System uses ultra short pulse RF energy delivering 40Watts/cm2 power density and 12Joule/cm2 energy density, and affects the mucosa whilst preserving the submucosa.
~Clinical trials have suggested that it is safe and effective for treating non-dysplastic IM, LGD and HGD in Barrett's oesophagus . Long term data show the effect to be durable over 5 years."
15923401|NCT03471039|Drug|PACAP27|Infusion of PACAP27 over 20 minutes.
15923402|NCT03471039|Drug|Saline|Infusion of Saline over 20 minutes.
15923403|NCT03471026|Diagnostic Test|Advanced MRI sequences|Structural, diffusion and perfusion MRI sequences
15923404|NCT03471000|Other|Short implants Treatment|Short implants are placed in the alveolar bone and a clinical Ostell and Periotest evaluation of the implants after a period of time is done. Analysis of periapical radiographs and CBCT images after a period of time. Bone around the implant was measured, marginal bone level loss is determined.
15923405|NCT03471000|Other|Regular implants Treatment|Sinus lift procedure is done and regular implants are placed in the alveolar bone and a clinical Ostell and Periotest evaluation of the implants after a period of time is done. Analysis of periapical radiographs and CBCT images after a period of time. Bone around the implant was measured, marginal bone level loss is determined.
15923406|NCT03470987|Procedure|Phase I Periodontal therapy|Oral hygiene instuction, scaling and root planning
15923407|NCT03470987|Dietary Supplement|Metabolic control|Calorie restricted diet
15923408|NCT03470974|Behavioral|Self-titration strategy|The self-titration strategy allows patients or medical professionals to adjust their medicine (additional, maintain, or decrease dose) depending on a bespoke plan. The bespoke plan for hypertensive patients involves setting target blood pressure, self-monitoring blood pressure, recording blood pressure readings and constructing a medication titration schedule. Each medication titration step is conducted based on the average home BP measurement readings.
15923409|NCT03470961|Drug|Anti-Tlymphocyte Globulins|Induction therapy regimen in simultaneous pancreas kidney transplantation
15923410|NCT03470961|Drug|Anti-Thymocyte Globulins|Induction therapy regimen in simultaneous pancreas kidney transplantation
15923411|NCT03470948|Other|Observe postoperative complications|The aim of this study is to confirm the utility of a 10-point Surgical Apgar Score to rate surgical outcomes in Whipples procedure in patients with pancreatic cancer.
15923412|NCT03470922|Biological|Relatlimab|Specified dose on specified day
15923413|NCT03470922|Biological|Nivolumab|Specified dose on specified days
15923414|NCT03470909|Procedure|Skin-Sparing Mastectomy (SSM)|"For patients undergoing SSM, 10 points of interest in radial localization have been selected for investigation of the presence of residual breast tissue.
~The points are located under the remaining skin envelope and will be investigated by performing small biopsies with a cervical biopsy forceps.
~Additionally, the distance between the surface of the specimen and the glandular tissue will be explored at five points at the base of the removed breast.
~These histological sections will be radially oriented."
15923447|NCT03470649|Drug|Iron Isomaltoside 1000|Iron Isomaltoside 1000 would be intravenously administrated to treatment group after main procedure of total knee arthroplasty.
15923448|NCT03470636|Device|HeartLight X3|Pulmonary vein isolation
15923660|NCT03468985|Other|Questionnaire Administration|Ancillary studies
15923415|NCT03470909|Procedure|Nipple-Sparing Mastectomy (NSM)|"For patients undergoing NSM, 14 points of interest in radial localization have been selected for investigation of the presence of residual breast tissue, i.e. comparing to SSM, 4 additional biopsies will be taken behind the peripheral part of the areola.
~The points are located under the remaining skin envelope and will be investigated by performing small biopsies with a cervical biopsy forceps.
~Additionally, the distance between the surface of the specimen and the glandular tissue will be explored at five points at the base of the removed breast.
~These histological sections will be radially oriented."
15923416|NCT03470896|Procedure|preanesthesia teleconsultation|According to his allocated group, patient will have a teleconsultation at home/at work with an anaesthesiologist.
15923417|NCT03470896|Procedure|preanesthesia traditional consultation|According to his allocated group, patient will have a traditional consultation with an anaesthesiologist in the surgical center Emile Galle.
15923418|NCT03470883|Other|Evaluation of the long-term complete remission rate (> 12 months)|Evaluation of the long-term complete remission rate (> 12 months)
15923419|NCT03470870|Other|Comparative analysis of the characteristics|"Predictive nomogram of short-term hospitalization (less than two days after surgery)
~Factors influencing the variations of average stay lenght
~Morbidity of the ERAS program"
15923420|NCT03470857|Diagnostic Test|Patients|The FDG PET/CT imaging will be performed as part of typical medical procedures related to the diagnosis and monitoring of cancers at the Oncology Center in Bydgoszcz, Poland
15923421|NCT03470844|Behavioral|Face-to-face neurocognitive tests|Assessment of attention, processing speed, working memory and executive function
15923422|NCT03470844|Behavioral|Psychological screening|Screening for the symptoms of depression, anxiety and post-traumatic stress disorder
15923423|NCT03470844|Other|fMRI|Brain volume, chemical markers, functional outcome
15923424|NCT03470844|Behavioral|Quality of Life Self-Assessment data|EQ-5D will be converted into a utility score using standard EQ-5D UK tariffs
15923425|NCT03470818|Other|Preparatory instructional videos (flipped classroom model)|"The intervention consists in the provision of preparatory instruction about the medical knowledge required to complete the task work of the upcoming simulated acute care clinical situation. The format used to convey this off-loaded educational content will be short (approximately 15 minutes) narrated video PowerPoint presentations; every relevant medical situation incorporated in the simulation case will have a dedicated video presentation.
~These videos will be available to the intervention group participants on a web-based platform one week prior to the simulation session"
15923426|NCT03470818|Other|Sham video|"Participants in the control group will be called to watch an online video prior to the simulation activity. However, this video presentation will not have any form of information regarding the upcoming simulation case; it will be an introductory video discussing the capacities of the simulation facility. This will limit any unwanted snowball effect where discussion between research participants could lead the control group participants to inquire about a video presentation that they would not exposed to."
15923427|NCT03470805|Drug|Olaparib|Olaparib will be dispensed to patients on Day 1 and every 28 days thereafter until disease progression, unacceptable toxicity, withdraws from the study or closure of the study
15923428|NCT03470792|Device|Microcirculation examination|Sublingual microcirculation images were recorded using an incident dark-field video microscope
15923429|NCT03470779|Other|Physiotherapy|Treatment group participants will participate in weekly group physiotherapy and psychotherapy sessions as part of the standard program procedure.
15923430|NCT03470779|Other|Psychotherapy|Treatment group participants will participate in weekly group physiotherapy and psychotherapy sessions as part of the standard program procedure.
15923431|NCT03470766|Device|Nevro Senza System (HF10 Therapy)|Nevro 10kHz High Frequency Spinal Cord Stimulation
15923432|NCT03470753|Other|Number of Exercises|Subjects will receive either 2 or 4 exercises to evaluate the short-term recall and performance.
15923433|NCT03470753|Other|Type of Instruction|The type of instruction in phase 1 will be compared: Instruction by providing a handout only vs being instructed by a provider and practiced by the patient with provider feedback.
15923434|NCT03470753|Other|Delivery Type|In phase 2 subjects will be provided 4 exercises using only a handout vs delivered to them electronically with the addition of a video.
15923435|NCT03470753|Other|Mobile Reminder|A text-message based mobile reminder tool will be utilized to engage with subjects via texting on a daily basis to provide reminders and encouragement to perform their home exercises.
15923436|NCT03470740|Behavioral|rheumatoid arthritis self-management program|The intervention group received the rheumatoid arthritis self-management program which was based on Bandura's theory of self-efficacy and proposes that self-efficacy is influenced by four information sources: mastery of experience, social modeling, social persuasion and one's physical and emotional states. To enhance participants' self-management skill, the following strategies were employed: peer story-telling, assessment, family involvement, goal setting, self-monitoring, self-evaluation, and phone calls consultation.
15923437|NCT03470727|Device|Citrate dialysate|Change form acetate to citrate dialysate
15923438|NCT03470714|Other|Force Irradiation|For the force irradiation, while the subjects perform dominant elbow flexion at an angular velocity of 60°/s for concentric contractions, 30°/s for eccentric contractions, at 90° elbow flexion position for isometric contractions with a maximal effort level, electrical activity of the non-dominant biceps brachii and triceps brachii muscles are recorded.
15923439|NCT03470714|Other|Kinesiotaping|For kinesiotaping, the elbow positioned in 30°-45° flexion and kinesiotaping facilitation technique is applied origin to insertion of non-dominant biceps brachii muscle before 24 hours the experiment.
15923440|NCT03470701|Other|Mailed Urinalysis Smartphone Kit|Patients who fail to complete albuminuria screening after the initial reminder to do so, will be contacted by phone and offered a mailed smartphone urinalysis kit. Agreeable patients will then receive the mailed kit and instructions to use their smartphone camera to analyze a urine dipstick.
15923441|NCT03470688|Biological|Originator|Originator anti-TNF agents
15923442|NCT03470688|Biological|Biosimilar|Biosimilar anti-TNF agents
15923443|NCT03470675|Drug|Epidural saline + IV saline|Sterile saline injection in the epidural catheter and in the intravenous catheter
15923444|NCT03470675|Drug|Epidural morphine 3 mg + IV saline|Morphine 3 milligrams injection in the epidural catheter and sterile normal saline intravenous catheter
15950178|NCT03262961|Drug|Placebo Oral Tablet|
15923450|NCT03470623|Device|steel screws|Hallux valgus are treated with a distal chevron osteotomy of first metatarsal and fixed using the steel screw
15923451|NCT03470610|Drug|Progesterone|6 mg estradiol and vaginal and rectal progesterone
15923452|NCT03470597|Other|dietary iodine restriction on subjects with iodine overload|In this case registry study (observational study),all intervention will be performed not for research purposes, but only part of routine treatment, which will be recorded in database of the registry study.
15923453|NCT03470584|Other|Diet Exposure|Vegetarian diet vs nonvegetarian diet
15923454|NCT03470571|Diagnostic Test|CMR|Outcome analysis of CMR features in suspected myocarditis patients
15923455|NCT03470558|Other|Dietary habits|Sleeve gastrectomy patients will be asked to monitor dietary habits for 1 week before surgery and at 2, 6, and 12 months after surgery.
15923456|NCT03470545|Drug|mavacamten|mavacamten capsules
15923457|NCT03470545|Drug|Placebo|placebo oral capsule
15923458|NCT03470532|Drug|buccal infiltration of 4% Articaine with Epinephrine|Articaine Hydrochloride 4 % / Epinephrine 1:200,000 1.8 ML Cartridge
15923459|NCT03470532|Drug|buccal infiltration of 2% Mepivacaine with Epinephrine|Mepivacaine Hydrochloride 2% Epinephrine 1:200,000 2.2 Ml Cartridge
15923460|NCT03470506|Other|Stool Samples|Stool samples will be collected at baseline and 3 months to assess differences in microbiome composition between groups
15923461|NCT03470493|Diagnostic Test|ApneaLink Air|ApneaLink Air to be used on each participant undergoing PSG
15923462|NCT03470480|Device|Real Repetitive transcranial magnetic stimulation|A real magnet will be used during rTMS treatments, which will look identical to the sham magnet. The participants and treatment facilitator will be blinded to which magnet will be used. High frequency repetitive transmagnetic stimulation (rTMS) will be directed at left dorsolateral prefrontal cortex (DLPFC) during 10 daily treatments within two weeks then 6 more treatments during the following month.
15923463|NCT03470480|Device|Sham Repetitive transcranial magnetic stimulation|A sham magnet will be used during rTMS treatments, which will look identical to the real magnet. The participants and treatment facilitator will be blinded to which magnet will be used. The sham rTMS treatments will be directed at left dorsolateral prefrontal cortex (DLPFC) during 10 daily treatments within two weeks then 6 more treatments during the following month.
15923464|NCT03470480|Behavioral|Methamphetamine visual cues|Just before each rTMS session, participants will be shown methamphetamine-related pictures
15923465|NCT03470480|Behavioral|Neutral visual cues|Just before each rTMS session, participants will be shown neutral pictures
15923466|NCT03470467|Other|No intervention|No intervention planed
15923467|NCT03470454|Drug|Linagliptin Oral Tablet|Linagliptin for blood glucose control
15923468|NCT03470441|Drug|FDY-5301|FDY-5301 will be administered once, intravenously, by a healthcare professional. Dosage will be administered on a body weight basis, according to treatment assignment and using the subject's body weight determined on the dose administration day.
15923469|NCT03470441|Other|Placebo|Placebo will be administered intravenously by a healthcare professional. Dosage will be administered on a body weight basis, according to treatment assignment and using the subject's body weight determined on the dose administration day.
15923470|NCT03470402|Other|RealRisks|RealRisks is a web-based patient decision aid with modules on risk assessment, family history and breast cancer, genetic testing, and prevention options. Participants enter family history data into RealRisks, and RealRisks calculates 5-year breast cancer risk, lifetime breast cancer risk, and the probability of carrying a BRCA mutation. This information is then interactively presented to the participant. RealRisks facilitates the participant in identifying their intention to undergo BRCA genetic testing and the factors that are important to the participant in making this decision. RealRisks produces a summary of all of this information that the participant can print and take with her to a health care appointment.
15923471|NCT03470402|Other|BNAV|BNAV is a web-based decision support tool for healthcare providers with educational modules on genetic testing, chemoprevention, patient-centered care, and screening. BNAV also provides providers with a table outlining their enrolled patients' breast cancer risk, eligibility for genetic testing, and stated preferences.
15923472|NCT03470402|Other|iNYP|Enrolled patients will have their eligibility for BRCA genetic testing flagged in iNYP, the hospital's portal for visualizing EHR data (standard practice).
15923473|NCT03470402|Other|Standard Educational Material|Enrolled patient participants will be sent standard educational brochures on genes and breast cancer and the CUMC breast cancer prevention clinic
15923474|NCT03470402|Other|High-Risk Message|Enrolled patient participants will receive a letter that informs them that they meet eligibility criteria for BRCA genetic testing, outlines prevention options, and recommends discussing genetic counseling referral with their health care provider (standard practice).
15923475|NCT03470389|Procedure|HVPG measurement|Each patient's computed tomography, blood tests, Doppler ultrasound and HVPG measurement will be performed within 30 days and treatments that may affect HVPG value will be avoided during this period.
15923476|NCT03470376|Dietary Supplement|Nutraceutical combination (NC)|An oral NC (red yeast rice-derived monacolin K 3 mg, berberine 500 mg, policosanol 10 mg, astaxanthin 0.5 mg, folic acid 0.2 mg and coenzyme Q10 2 mg) one pill/day was administered for 3 months along with prosecution of standardized diet regimen
15923477|NCT03470376|Behavioral|No nutraceutical combination (noNC)|Prosecution of standardized diet regimen for 3 months
15923478|NCT03470363|Drug|Sevoflurane Volatile Liquid|
15923479|NCT03470363|Drug|Bupivacaine / SUFentanil|
15923480|NCT03470350|Drug|Galunisertib|treatment with capecitabine and galunisertib
15923481|NCT03470337|Drug|Phlogenzym|Bromelain / Trypsin / Rutoside
15923482|NCT03470337|Other|Placebo|
15923483|NCT03470324|Device|[standard STN]|standard stimulation on subthalamic (STN) contacts High frequency deep brain stimulation with variable (best individual) stimulation on subthalamic contacts
15923484|NCT03470324|Device|[STN+SNr]|Combined stimulation of the subthalamic nucleus (STN) and the substantia nigra pars reticulata (SNr) high frequency deep brain stimulation of combined (best individual) subthalamic and nigral stimulation
15923485|NCT03470324|Behavioral|Swallowing therapy|Swallowing therapy with speech therapist
15923486|NCT03470311|Biological|Benralizumab|30mg in 1mL pre-filled syringe
15923487|NCT03470311|Biological|Placebo|Matched placebo (1mL) in pre-filled syringe
15923488|NCT03470298|Procedure|Endometrial scratching|The patients in study undergo endometrial scratch technique after being randomly assigned in to one of two groups . First group undergo oocyte pickup just after finishing oocyte pick up and the other group undergo oocyte pickup one week before starting COH.ManualVaccum Aspiration (MVA) size 5 moved from below upwards with suction ,scrachning anterior uterine wall then posterior then left lateral uterine wall then right lateral uterine wall and lastly fundus. All patients were prescribed vibramycine 100 mg twice daily for 3 days starting one day before procedure
15923489|NCT03470285|Procedure|Multiparametric MR imaging (mpMRI)|The main objective of the study is to assess the diagnostic accuracy of mpMRI in small renal tumors. The study characteristics will comply with recommended methods (Quadas, Stard). The population to be included will be representative of patients who would benefit from mpMRI if it is demonstrated to be accurate. In this project, the MR protocol will used the conventional MR sequences either on 1.5 or 3T systems and do not require development. Each center may use their own protocol as long as it includes the mandatory sequences.
15923490|NCT03470272|Device|FB Professional LED Red light therapy|FB Professional LED red light therapy is a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist and thighs. Measure before and after effects of device unit. Three measurements before of circumference of abdomen area and three measurements after comparing the results.
15923491|NCT03470272|Device|Effects of Red Light LED Therapy on Body Contouring|Intervention is to take a sample and measure before and after using a sham unit (placebo) and take three measurements of abdominal before treatment and three measurements after sham treatment and compare to controlled treatment.
15923492|NCT03470259|Drug|IV adminstration of EMI-137|Intravenous administration of the fluorescent tracer EMI-137 approximately two hours before incision. Thereafter will be an observational period of an hour.
15923493|NCT03470259|Device|Multispectral Fluorescence Reflectance Imaging|A multispectral Near Infrared Fluorescence (NIRF) camera system sensitive for EMI-137 fluorescence will be used for only ex-vivo Multispectral Fluorescence Reflectance Imaging (MFRI) of the thyroid gland and/or lymph node compartment.
15923494|NCT03470259|Device|Spectroscopy|A spectroscopy system sensitive for EMI-137 fluorescence will be used for only ex-vivo spectroscopy of the thyroid gland and/or lymph node compartment.
15923495|NCT03470246|Behavioral|PACO intervention for CABG patients|The PACO intervention is based on post-operative guidance to replace prolonged SB with PA in the rehabilitation of patients recovering from coronary artery bypass grafting (CABG). The guidance will be provided to the patients with the combination of ExSed smart phone application, accelerometer and cloud system. In addition, exercise guidance (short video files) and regular mobile phone contacts from physiotherapist will be provided to the intervention patients.
15923496|NCT03470246|Behavioral|PACO intervention for AVR patients|The PACO intervention is based on post-operative guidance to replace prolonged SB with PA in the rehabilitation of patients recovering from aortic valve replacement (AVR). The guidance will be provided to the patients with the combination of ExSed smart phone application, accelerometer and cloud system. In addition, exercise guidance (short video files) and regular mobile phone contacts from physiotherapist will be provided to the intervention patients.
15923497|NCT03470246|Behavioral|PACO intervention for MVR patients|The PACO intervention is based on post-operative guidance to replace prolonged SB with PA in the rehabilitation of patients recovering from mitral valve repair (MVR). The guidance will be provided to the patients with the combination of ExSed smart phone application, accelerometer and cloud system. In addition, exercise guidance (short video files) and regular mobile phone contacts from physiotherapist will be provided to the intervention patients.
15923498|NCT03470207|Procedure|Post-pulmonary embolism follow up protocol|Structured post-pulmonary embolism follow up protocol (outlined in Aim 1)
15923499|NCT03470194|Other|Interpretation Modality: In Person|Use of In-Person interpretation support for LEP participant during clinical appointment
15923500|NCT03470194|Other|Interpretation Modality: Telephonic|Use of telephonic interpretation support for LEP participant during clinical appointment
15923501|NCT03470181|Dietary Supplement|Ensure|Participants will perform a Nutrient Drink Test. This consists of drinking 125mL of liquid Ensure four times, at five-minute intervals.
15923502|NCT03470168|Device|Hyperbaric Oxygenation Therapy|Received the Hyperbaric Oxygen therapy treatment at 2.4 ATA for 90 minutes each day.
15923503|NCT03470168|Device|Normobaric Oxygenation therapy|Received the Normobaric Oxygen therapy treatment at 1 ATA for 90 minutes each day.
15923504|NCT03470155|Procedure|mitral valve repair|operative reconstruction
15923505|NCT03470142|Procedure|traditional laparoscopy-assisted surgery|All surgical procedures will be performed by the surgery team ,which is leaded by professor Sun Dong-Hui and Wang Quan. The traditional laparoscopic operation undergo and then a small incision(5cm) is made in the middle of the lower abdominal wall to trim the mesangial membrane and remove the specimen. At last the anastomosis operation undergo by the laparoscopic operation.
15923506|NCT03470142|Procedure|total laparoscopic surgery with no incision (natural orifice transluminal endoscopic surgery, NOSES)|All surgical procedures will be performed by the surgery team ,which is leaded by professor Sun Dong-Hui and Wang Quan. The whole procedures undergo by total laparoscopic surgery with no incision in the abdominal wall. The specimen then will be removed through natural orifice (anal).
15923507|NCT03470129|Device|fissure sealing|sealing of occlusal fissures with either the conventional sealant, Helioseal F, or the new sealant, Helioseal F Plus, which provides an additional feature and an improved formulation
15923508|NCT03470116|Device|Laryngoscopy with Mac Grath|Patients of this group will benefit MacGrath MAC video laryngoscopy for intubation after curarization
15923509|NCT03470116|Device|direct laryngoscopy|Patients of this group will benefit direct laryngoscopy for intubation after curarization
15923510|NCT03470103|Drug|Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)|Use of intravitreal aflibercept in routine clinical practice in Latin America
15923511|NCT03470090|Behavioral|Neuromuscular Exercises|In the experimental group, the subjects who were taken into the study were taken to the neuromuscular exercise (NME) program after the pre-treatment evaluations. The subjects in this group were given classical physiotherapy and NME performed 6 days a week, 1 set of 10 times physiotherapist control. NME was including warming, neuromuscular exercises (balance, muscle strengthening, proprioception, sensorimotor system training, joint stabilization and postural control exercises) and cooling periods.
15923880|NCT03467373|Drug|Cyclophosphamide|Cyclophosphamide 750 mg/m^2 administered IV on Day 1 of each 21-day cycle
15923512|NCT03470090|Behavioral|Conventional Group|In the control group, the subjects who were taken into the study were taken to the classical physiotherapy (hotpack (HP), ultrasound (US), transcutaneous electrical stimulation (TENS)) and conventional exercises program after the pre-treatment evaluations.
15923513|NCT03470077|Drug|IV nalbuphine 0.1 mg/kg with induction of anesthesia.|"Group A: 40 patients will receive IV nalbuphine 0.1 mg/kg with induction of anesthesia.
~."
15923514|NCT03470077|Drug|IV nalbuphine 0.1 mg/kg at the end of surgery.|Group B: 40 patients will receive IV nalbuphine 0.1 mg/kg at the end of surgery just before discontinuation of anesthesia.
15923515|NCT03470051|Diagnostic Test|QT Ultrasound|All subjects will be asked to agree to an ultrasound-guided breast needle biopsy by a qualified radiologist experienced in this procedure if not already completed prior to study entry.
15923516|NCT03470038|Drug|NGF|Intramuscular injection
15923517|NCT03470038|Drug|Isotonic saline|Intramuscular injection
15923518|NCT03470025|Other|Psychological Intervention|"F-TPI group will be followed for a period of six months with a telephone-based and a face to face psychological intervention, performed by a clinical psychotherapist .
~TPI group will be followed for a period of six months with a TPI characterized by 10 telephone clinical interviews, performed by a clinical psychotherapist.
~CTRL group with COPD SoC without PI will follow the standard follow-up program for COPD patients after PR."
15923519|NCT03470012|Device|Multi-Purpose Gentle Tape|The Multi-Purpose Gentle Tape is a general purpose medical adhesive tape for medical applications used primarily to secure dressings, lightweight tubing, and devices to skin.
15923520|NCT03469999|Drug|Dysport Injectable Product|All participants will receive Dysport injection at multi levels in the spastic lower limb(s)
15923521|NCT03469986|Device|Marcus Autism Center Investigational Device|This trial will ascertain whether the binary results of autism or not-autism as determined by the Marcus Autism Center Investigational Device match expert clinical diagnostic opinion. The investigational device is designed to measure visual attention to social information in the environment relative to normative, age-specific benchmarks; these measurements assess presence (primary efficacy outcome) and severity (secondary outcomes) of autism spectrum disorder in 16- to 30-month-old children.
15923522|NCT03469973|Procedure|Partial adenoidectomy|"The procedure will be completely visualized with a 45 degrees, 4- mm nasal endoscope; the upper part of the adenoid will be removed using the microdebrider, while the lower part will be preserves to maintain the velopharyngeal competence.
~• Adenoid enlargement causing Obstructive Sleep-Disordered Breathing (OSDB) with velopharyngeal insufficiency (proved or suspected)."
15923523|NCT03469960|Drug|Ipilimumab|Ipilimumab 1 mg/kg every 6 weeks
15923524|NCT03469960|Drug|Nivolumab|Nivolumab 3 mg/kg every 2 weeks
15923525|NCT03469947|Drug|Tranexamic Acid|1 gram of prehospital Tranexamic Acid
15923526|NCT03469934|Drug|ANB020|ANB020
15923527|NCT03469934|Drug|Placebo|Placebo
15923528|NCT03469921|Drug|administered therapeutic regimens|administered therapeutic regimens
15923529|NCT03469895|Drug|ibrutinib ou idelalisib|treatment by ibrutinib or idelalisib for autoimmune cytopenia
15923530|NCT03469882|Dietary Supplement|High protein nutrition|Patients in the HPE group will be submitted to nutritional support preferably through the enteral route. Energy expenditure will be determined by indirect calorimetry. They will receive 2.0 to 2.2 grams/kg/day of protein.
15923531|NCT03469882|Device|Cycle ergometry exercise|Patients will be submitted to two daily sessions of exercise (cycle ergometry) 15 minutes duration each, during the 7 days of the week. The intervention will be maintained exclusively duting the patient's stay in the ICU. The cycle ergometer will be the MotoMed Letto II (Reck Technik, Germany).
15923532|NCT03469882|Other|Usual care group|Participants randomized to the usual care group will receive usual care protein and exercise.
15923533|NCT03469869|Other|balanced and sustainable diet|"the intervention group will get menu recommendation of restriction calorie balanced and sustainable diet for 8weeks. the other group will get menu recommendation of balanced diet for 8 weeks. these menus are given in the apps named EatsUp.
~the intervention group will get menu recommendation of restriction calorie balanced and sustainable diet for 8 weeks. the other group will get menu recommendation of balanced diet for 8 weeks. these menus are given in the apps named EatsUp."
15923534|NCT03469856|Drug|Prasugrel monotherapy|A multicenter, single arm, open-label trial of in patients with chronic stable angina
15923535|NCT03469843|Other|Non intervention|patients without intervention
15923536|NCT03469830|Other|SSCP|Insert
15923537|NCT03469830|Other|SPMS|Pressure therapy
15923538|NCT03469817|Diagnostic Test|MRI|"Patients who are part of Arm 2 will undergo an MRI at their 1 year post-operative visit."
15923539|NCT03469804|Drug|Pembrolizumab|Route: intravenous infusion Dose regimen: 200 mg per infusion every 3 weeks Duration of treatment: 6 months (8 cycles)
15923540|NCT03469791|Procedure|Surgical treatment of Degenerative Spondylolisthesis|
15923541|NCT03469778|Device|Robotic Therapy|Robotic Therapy
15923542|NCT03469765|Other|does not apply|biological sample taking: urine, blood
15923543|NCT03469752|Behavioral|Parent education classes|8 weekly classes for fathers and youth (10-14 years) at community centers focused on improving parenting skills, youth energy balance related behaviors and weight status
15923544|NCT03469726|Diagnostic Test|Contrast-enhanced Diffusion-weighted MRI|An MRI scan enhanced with intravenous contrast and with diffusion imaging at several B-values
15923545|NCT03469713|Drug|Nivolumab|"Hypofractionated radiation will be administered to a metastatic disease site at a dose and schedule of 30 Gy in 3 consecutive fractions. The day of first administration of Nivolumab will be designated as Time 1. Nivolumab will be given as flat dose of 240 mg in intravenous infusion beginning on day 1 every 14 days for 6 months, than switch to 480 mg q4-weekly in responding (CR, PR, SD) patients until PD or unacceptable toxicity .
~SRT will be administered between the first and second administration of Nivolumab (7 days after the first infusion of Nivolumab)."
15923546|NCT03469700|Other|general anesthesia|Induction of general anesthesia will be performed followed by endotracheal intubation. General anesthesia is induced with 0.5-1 μg/kg fentanyl, 1.5-2 mg/kg propofol and 1-2 mg midazolam. Then, endotracheal intubation is facilitated by 0.15 mg/kg nimbex. Anesthesia is maintained by 1-1.5% sevoflurane, 0.5 μg/kg/h fentanyl, 0.6 mg/kg/h rocuronium, 60% nitrous oxide and 40% oxygen with Ultiva (Remifentanyl) 0.1-0.2 μg/kg/hr
15923881|NCT03467373|Drug|Doxorubicin|Doxorubicin 50 mg/m^2 administered IV on Day 1 of each 21-day cycle
15923547|NCT03469700|Other|Paravertebral block|Bilateral paravertebral block guided by a nerve stimulator will be performed by injecting local anesthetic mixture from levels T11 to T6. Each 20 ml of the mixture will contain: 6 ml lidocaine 2%; 6 ml lidocaine 2% with adrenaline 5 μg /ml; 5 ml bupivacaine 0.5%; 50μg fentanyl (1 ml); and 2 ml saline 0.9%
15923548|NCT03469700|Other|Placebo PVB|Placebo bilateral paravertebral block guided by a nerve stimulator will be performed by injecting normal saline from levels T11 to T6.
15923549|NCT03469687|Device|Symax uncemented hip stem|
15923550|NCT03469674|Radiation|Vaginal brachytherapy|Internal radiation of the vaginal vault using a vaginal cylinder, 21 Gy in 3 out-patient sessions over 2 weeks
15923551|NCT03469674|Radiation|External beam radiotherapy|External beam pelvic radiotherapy on a linear accelerator, 48.6 Gy in 27 out-patients sessions over 5.5 weeks
15923552|NCT03469674|Other|Observation|No radiation therapy, but active follow-up and quality of life questionnaires as in the groups who have adjuvant treatment
15923553|NCT03469648|Procedure|Air-Test|The Air Test simply consisted in breathing room air for 5 min during anesthesia while measuring peripheral oxygen saturation by Pulse oximetry
15923554|NCT03469635|Other|Nutritional deficiencies in pregnant women after bariatric surgery|compare maternal nutritional parameters and neonatal outcomes after Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) and to assess the impact of nutritional alterations on fetal growth.
15923555|NCT03469622|Device|EndoRings|EndoRings-assisted colonoscopy
15923556|NCT03469622|Device|Standard colonoscopy|Standard colonoscopy without any additional devices
15923557|NCT03469609|Other|mucous fistula refeeding|Transfer of infants' own stool
15923558|NCT03469596|Diagnostic Test|MRI sequence|several MRI sequence before and after contrast product injection.
15923559|NCT03469583|Drug|EYP001|EYP001 self administered capsules, morning, with non carbonated water
15923560|NCT03469583|Drug|Entecavir 1 MG|Entecavir self administered tablets, morning, with non carbonated water
15923561|NCT03469570|Device|EV1000 Clinical Platform with Assisted Fluid Management (AFM) Feature|Subjects enrolled in the validation study will have their fluid management decisions guided by the AFM Feature.
15923562|NCT03469557|Drug|Tislelizumab|Subjects will be treated with BGB A317 200 mg IV on Day 1 during each 21-day cycle. BGB A317 will be administered until disease progression, intolerable toxicity, or treatment discontinuation for any other reason.
15923563|NCT03469557|Drug|Cisplatin|Subjects will be treated with cisplatin 80 mg/m² IV on Day 1 during each 21-day cycle. Cisplatinwill be given for up to 6 cycles.
15923564|NCT03469557|Drug|5-FU|Subjects will be treated with 5-FU 800 mg/m²/day IV using continuous pumping system on Days 1 through 5 during each 21-day cycle. 5-FU will be given for up to 6 cycles.
15923565|NCT03469557|Drug|Oxaliplatin|Subjects will be treated with oxaliplatin 130 mg/m² IV on Day 1 during each 21-day cycle. Oxaliplatin will be administered for up to 6 cycles.
15923566|NCT03469557|Drug|Capecitabine|Subjects will be treated with capecitabine 1000 mg/m² orally twice daily (bid) Days 1 through 14 (14 days total) during each 21-day cycle. Capecitabine will be administered until disease progression, intolerable toxicity, or treatment discontinuation for any other reason.
15923567|NCT03469544|Other|complete blood picture ,serum urea and creatinine,liver function test,T3,T4,thyroid stimulating hormone,thyroglobuline and thyroglobuline anti body specific test Real time polymerase chain reaction|"complete blood picture ,serum urea and creatinine,liver function test,T3,T4,thyroid stimulating hormone,thyroglobuline and thyroglobuline anti body .
~specific test is quantitation of long non coding RNA HOTAIR by Real time polymerase chain reaction in peripheral blood,Enzyme linked Immunosorbent Assay for serum midkine level"
15923568|NCT03469531|Drug|Nimotuzumab|Patients receive nimotuzumab IV over 90 minutes on days 1, 8, 15, 22, 29, 36,43.
15923569|NCT03469531|Drug|Cisplatin|Patients undergo cisplatin, 25-40 mg/m2 a week for 4 or 5weeks
15923570|NCT03469531|Radiation|external-beam radiation|Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45-50.4Gy
15923571|NCT03469531|Radiation|brachytherapy|high-dose rate brachytherapy,6Gy once weekly,for a total of 24-30Gy
15923572|NCT03469518|Dietary Supplement|β-Cx plus PS plus GOS|
15923573|NCT03469518|Dietary Supplement|β-Cx plus PS|
15923574|NCT03469505|Behavioral|COPES|Cooperative Pain Education and Self-Management for chronic pain therapy.
15923575|NCT03469505|Behavioral|CBT-CP|Cognitive Behavioral Therapy for Chronic Pain
15923576|NCT03469492|Drug|Insulin|Insulin regimens will be adjusted on a weekly basis as needed to achieve a target blood glucose level.
15923577|NCT03469492|Behavioral|exercise|Exercise in accordance to the guidelines established by the American Diabetes Association.
15923578|NCT03469492|Dietary Supplement|Dietary counseling|Dietary counseling in accordance to the guidelines established by the American Diabetes Association.
15923579|NCT03469479|Drug|FOLFOX|Hepatic intra-arterial infusion via the tumor feeding arteries of Oxaliplatin , fluorouracil, and leucovorin
15923580|NCT03469479|Procedure|Hepatic resection|R0 resection
15923581|NCT03469466|Diagnostic Test|bedside ultrasound|bedside ultrasound imaging of the lungs
15923582|NCT03469453|Behavioral|Internet-Delivered Cognitive Behavioral Therapy|Therapist-supported CBT delivered online.
15923583|NCT03469440|Other|Continuous central venous oxygenation monitoring|"Central venous oxygen saturation will be targeted higher than 65% in non-cyanogenic patients and 55% in cyanogenic.
~First, isotonic crystalloid, 10 up to 20 mL/kg, will be administered in boluses to achieve continuous central venous oxygen saturation higher than 65% in non-cyanogenic and 55% in cyanogenic.
~Second, if not achieved with fluid administration, will be targeted by initiating and titrating inotropics (dobutamine or milrinone). If the mean arterial pressure is lower than 50 mm Hg will be associated epinephrine.
~If the ScvO2 is lower than 65% in non-cyanogenic and 55% in cyanogenic and the hemoglobin was lower than 8g/dl, red blood cells (20mL/Kg) will be transfused to achieve a hemoglobin level of at least 8g/dL."
15923584|NCT03469440|Other|Standard protocol|The control group will keep the standard therapy to achieve mean arterial pressure higher than 50mmHg, central venous pressure 8 to 12 mmHg, urinay debit higher than 0,5ml/kg/h, hemoglobin higher or equal than 8g/dL, arterial oxygen saturation higher or equal than 92% in non-cyanogenic and 80% cyanogenic, central venous oxygen saturation higher or equal than 65% in non-cyanogenic and 55% in cyanogenic.
15924161|NCT03465280|Procedure|Radiofrequency ablation|Removal of lesions via radiofrequency ablation
15923585|NCT03469414|Other|Life Space Assessment Scale|This nine question survey asks participants where they have gone in the last week, frequency of those visits, and how independently they went there.
15923586|NCT03469414|Other|6-Minute Push Test|The 6 Minute Push Test is a measure of endurance, and requires that the participant wheel themselves around two pylons that are located 15 meters apart for 6 minutes.
15923587|NCT03469414|Other|Forward Push Test|This measure of wheelchair propulsion speed asks patients to propel themselves as fast as they can over 20 meters. This task is performed twice, and the average time is used for the score.
15923588|NCT03469414|Other|Wheelchair Slalom Test|In this measure, participants propel themselves through an 18 meter slalom course at their maximum self-selected speed, wheeling around seven cones, separated by three, two, or one meter.
15923589|NCT03469414|Other|Craig Handicap Assessment and Reporting Technique|A measure of social participation in individuals with SCI.
15923590|NCT03469414|Other|PART-O|The PART-O is a community participation measure.
15923591|NCT03469414|Other|GPS Tracking|A GPS tracker will be attached to the wheelchairs of a subset of participants for one week. The GPS location is collected every minute, and mapped to Google Maps, which would allow calculation of speed of movement.
15923592|NCT03469401|Other|Intervention|Evaluation of sensibility, specificity, negative and positive predictive value of BD glucan in peritoneal fluid for diagnosis of fungal peritonitis, compared with fungal culture
15923593|NCT03469388|Diagnostic Test|Pulse wave analyses; central blood presaure parameters|Pulse wave analyses; central blood presaure parameters
15923594|NCT03469375|Drug|modified-FOLFIRINOX|LAPC patients with mFOLFIRINOX-based neoadjuvant therapy or not was set as the main intervention
15923595|NCT03469362|Procedure|Extracorporeal Urinary Diversion|Extra-corporeal urinary diversion, provided as part of standard of care, will have the ureters sutured into the ileal conduit by hand.
15923596|NCT03469362|Procedure|Intracorporal Urinary Diversion|Intracorporal Urinary Diversion, provided as part of standard of care, will have the ureters sutured into the ileal conduit using the Da Vinci robot.
15923597|NCT03469362|Device|Da Vinci Robot|Da Vinci Robotic Surgical System
15923598|NCT03469349|Drug|Actovegin|Actovegin intravenous infusion and tablets.
15923599|NCT03469349|Drug|Placebo|Actovegin placebo-matching intravenous infusion and tablets.
15923600|NCT03469336|Drug|PF-06763809|Three different concentrations will be administered to three different treatment fields: 2.3%, 0.8% and 0.23%
15923601|NCT03469336|Other|Vehicle|Vehicle matching PF-06763809.
15923602|NCT03469336|Drug|Calcipotriene/calcipotriol|Calcipotriene/calcipotriol 50 ug/mL solution
15923603|NCT03469336|Drug|Betamethasone|Betamethasone 1 mg/g solution
15923604|NCT03469323|Drug|Succinylcholine|Giving mini-dose succinylcholine to facilitate lung collapse during nonintubated VATS.
15923605|NCT03469323|Drug|Placebo|Giving placebo (normal saline) to facilitate lung collapse during nonintubated VATS.
15923606|NCT03469310|Drug|Acetaminophen 500Mg Cap|non-narcotic medication first with narcotic as second choice
15923607|NCT03469310|Drug|Tylenol #3 Oral Tablet|Narcotic medication first
15923608|NCT03469310|Drug|Tramadol|non-narcotic medication first with narcotic as second choice
15923609|NCT03469297|Device|Brown Glaucoma Implant|The Brown Glaucoma Implant (BGI) is an implantable device designed to lower intraocular pressure (IOP) in glaucoma patients by shunting aqueous humor from the anterior chamber of the eye to the surface of the eye. Because there are no physiologic sources of outflow resistance, the device can be engineered to target an IOP that is low enough to halt the progression to blindness in a patient suffering from glaucoma.
15923610|NCT03469284|Other|Best Practice|Given standard of care therapy
15923611|NCT03469284|Drug|Methylene Blue|Given lower dose PO
15923612|NCT03469284|Drug|Methylene Blue|Given medium dose PO
15923613|NCT03469284|Drug|Methylene Blue|Given higher dose PO
15923614|NCT03469271|Drug|1,25 (OH)2 D3|0.25 micrograms, taken daily for eight weeks, orally
15923615|NCT03469271|Other|Inspiratory isometric resistance training|A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles.Participants in the active groups will breathe against a resistance set to generate 30% of maximal inspiratory pressure (PImax).
15923616|NCT03469271|Drug|Oral Placebo|Placebo will be created to mimic the appearance of the study drug
15923617|NCT03469271|Other|Sham Inspiratory Isometric Resistance Training|A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles. Participants in the sham group will train daily against a resistance set to only 15% PImax.
15923618|NCT03469271|Device|Threshold Inspiratory Muscle Trainer (IMT)|A small hand-held reusable device to increase muscle strength and endurance through inhalation therapy. Participants will inhale through a valve which provides resistance that increases the work of breathing and exercises the respiratory muscles.
15923619|NCT03469258|Drug|Pancrelipase|Zenpep is a combination of three enzymes (proteins). These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars. Zenpep is used to replace these enzymes when the body does not have enough of its own as a result of surgery and/or pancreatic cancer.
15923620|NCT03469245|Other|numerical simulation|After patients have been treated by fenestrated endovascular of society Vascutek data will be collected by society Vascutek and send to Predisurge society. They will perform numerical simulation and compare with the method of Vascutek.
15923621|NCT03469232|Drug|Huanglian-Jiedu Decoction|Huanglian-Jiedu Decoction includes 4 kinds of Chinese herbs as following: Huanglian (Rhizoma Coptidis), Huangbo (Cortex Phellodendri), Huangqin (Scutellaria baicalensis) and Zhizi (Scutellaria baicalensis). All of them were prepared as granule.
15923622|NCT03469206|Procedure|intra-arterial thrombectomy|It is the emergency surgical removal of emboli which are blocking blood circulation. It usually involves removal of thrombi (blood clots)
15923623|NCT03469206|Drug|Intravenous thrombolysis|alteplase is used in the intravenous thrombolysis. It catalyzes the conversion of plasminogen to plasmin, the major enzyme responsible for clot breakdown.
15924162|NCT03465280|Procedure|Monopolar suction diathermy|Removal of lesions via monopolar suction diathermy
15923624|NCT03469193|Procedure|internal PUC implanted with mechanical ancillary|The control group consists of patients operated with a mechanical ancillary (reference surgery in our department). In this technique, bone sections are made with a standardized ancillary (manually adjusted bone cutting guides), according to preoperative radiological planning. The positioning of the implants is done manually and controlled by the placement of test implants.
15923625|NCT03469193|Procedure|Internal PUC implanted with robotic assistance|Patients are operated by robotics (surgery that we want to develop systematically in our service). 3D modeling of the knee allows the operator to perform a dynamic planning taking into account the reducibility of the deformation and the model of the implant. The operator can position the implants in three dimensions of the space without difficulty. This makes it possible to visualize, before the bone resections, the angular correction obtained between 0 and 130° flexion and alignment of the prosthesis by visualizing the contact points between the two implants. Bone resections will be performed using a guided retro bone drill. The system retracts more or less the cutter according to the bone thickness to be removed. This technique requires the insertion of two threaded plugs in the tibia and two in the femur to position the sensors that will allow the acquisition of anatomical landmarks of the lower limb and then 3D modeling
15923626|NCT03469180|Other|Treadmill training|Treadmill training Each season will be supervised and last 45 minutes. Treadmill speed will be adjusted to the child's maximal heart rate (MHR) (between 65 to 75 percent of the MHR).
15923627|NCT03469180|Other|Whole body vibration training|Whole body vibration training whole body vibration frequence will be 50 Hertz and childrens will be standing position on vibration platform .
15923628|NCT03469167|Device|CEGP003|Application of CEGP003 to peptic ulcer bleeding
15923629|NCT03469167|Device|Injection Tx|Injection of epinephrine to peptic ulcer bleeding
15923630|NCT03469154|Other|Dyad training method|The training model for paediatric basic life support for laypersons involves a course based on pairs training together guided by instructional videos and with hands-on practice on resuscitation manikins.
15923631|NCT03469154|Other|Instructor led training method|The training model for paediatric basic life support for laypersons involves a course led by an instructor including hands-on practice on resuscitation manikins.
15923632|NCT03469141|Device|Pressure Relief Monitoring System|Biofeedback provided to the intervention group via the smartphone app will include: Visual (e.g., phone notification bar) and auditory reminders if PR (pressure relief) is not performed as scheduled, Real-time feedback during performance of PR maneuvers to ensure adequate PR (e.g., the app will indicate if the duration of PR is sufficient), and Aggregate counts of daily PR activity.
15923633|NCT03469128|Behavioral|Cognitive processing therapy|Psychological treatment for patients suffering from PTSD and SUD symptoms.
15923634|NCT03469128|Drug|Sertraline|Sertraline for the treatment of post-traumatic stress and SU disorders
15923635|NCT03469128|Other|Placebo Control|Placebo Control
15923636|NCT03469115|Diagnostic Test|Serum blood|Serum blood test for laboratory analysis to determine level of alpha defensin
15923637|NCT03469089|Drug|Ketamine 0.58|Ketamine (0.23 mg/kg bolus + 0.58 mg/kg/h)
15923638|NCT03469089|Drug|Ketamine 0.31|Ketamine (0.12 mg/kg bolus + 0.31 mg/kg/h)
15923639|NCT03469089|Drug|Modafinil|Modafinil tablet 100 mg placed in a capsule
15923640|NCT03469089|Drug|Placebo for ketamine|0.9 % NaCl infusion solution
15923641|NCT03469089|Drug|Placebo for modafinil|Placebo capsule for modafinil capsule
15923642|NCT03469076|Other|YUN ACN Cream|YUN ACN Cream with live probiotic bacteria (min. 10-6 à 10-7 CFU per application) applied twice daily (morning and evening) on the entire face
15923643|NCT03469063|Dietary Supplement|AferBio|Patients will use the product (AferBio/Placebo) once a day for seven days, and then twice a day, continuously (for a total of three months of use).
15923646|NCT03469037|Device|Optiflow with an inspired fraction of oxygen of 100%|Respiratory gaz heated and humidified system of delivery with a fraction of oxygen inspired of 100%
15923647|NCT03469037|Device|Optiflow with an inspired fraction of oxygen of 21%|Respiratory gaz heated and humidified system of delivery with a fraction of oxygen inspired of 21%
15923648|NCT03469024|Other|Home Rehabilitation Program|It consists in a home rehabilitation program performing electroanalgesia and an exercise program following the Mckenzie method. Patients will be instructed in the use of the TENS device using 5x9cm electrodes at the bilateral paravertebral level, the patients that present radicular pain, the electrodes will be placed in the path of the affected nerve. The realization of exercises will be through the application of an Mckezie protocol. The duration will be the same as that used to carry out the Mckenzie protocol. Mckenzie exercises are designed to make changes in the internal components periarticular of the spine.
15923649|NCT03469024|Other|e-Health program|It consists in an e-Health rehabilitation program through a web platform performing electroanalgesia and an exercise program following the Mckenzie method. Patients will be instructed in the use of the TENS device using 5x9cm electrodes at the bilateral paravertebral level, the patients that present radicular pain, the electrodes will be placed in the path of the affected nerve. The realization of exercises will be through the application of an Mckezie protocol. The duration will be the same as that used to carry out the Mckenzie protocol. Mckenzie exercises are designed to make changes in the internal components periarticular of the spine.
15923650|NCT03469011|Drug|Imatinib Oral Tablet|3+3 trial design. Cohorts of 3-6 patients with escalating imatinib doses. No intra-patient dose escalation allowed.
15923651|NCT03468998|Device|Socket Grafting with small particle allograft|Small Particle Bone Allograft of 0.25-1.0 mm placed in extraction socket
15923652|NCT03468998|Device|Socket Grafting with large particle allograft|Large Particle Bone Allograft of 1.0-2.0 mm placed in extraction socket
15923653|NCT03468998|Device|Lateral ridge augmentation with small particle allograft|Small Particle Bone Allograft of 0.25-1.0 mm used in lateral ridge augmentation (Guided Bone Regeneration) and covered with a collagen membrane
15923654|NCT03468998|Device|Lateral ridge augmentation with large particle allograft|Large Particle Bone Allograft of 1.0-2.0 mm used in lateral ridge augmentation (Guided Bone Regeneration) and covered with a collagen membrane
15923655|NCT03468985|Drug|Cabozantinib|Given PO
15923656|NCT03468985|Drug|Cabozantinib S-malate|Given PO
15923657|NCT03468985|Biological|Ipilimumab|Given IV
15923661|NCT03468972|Drug|Immunosuppressive treatment|At 3 months after randomization, patients in the corticosteroid arm who have persistent proteinuria of ≥ 1.0 g/g creatinine, or fast decline in eGFR ≥ 15% from the baseline value, will additionally receive cyclosphosphamide during the following 3 months. Patients who have substantial decreased amount of proteinuria < 1.0 g/g creatinine at 3 months will continue protocol-based corticosteroids during the same period. At 6 months after randomization, patients who receive add-on cyclophosphamide will switch to azathioprine as a maintenance therapy and those who receive corticosteroids alone will discontinue the treatment and will be followed up during 24 months thereafter. Assessment of outcome will be done at 6 months and at 36 months.
15923662|NCT03468972|Other|intensive supportive care|During 3-6 months before the enrollment, all patients will receive maximal supportive care including the use of RAS blockers, blood pressure control with a target of <130/80 mmHg, and protein restriction diet. If proteinuria does not decrease < 1.0 g/g creatinine, patients will be randomly assigned to continue supportive care, or to receive corticosteroids.
15923663|NCT03468959|Behavioral|Maternal Supplemental PUFA Intake|Maternal Supplemental PUFA Intake included sources from the questionnaires and plasma
15923664|NCT03468946|Other|salty taste perception|"salty taste perception in high caries risk, medium caries risk, low caries risk.
~The aim of this study was to evaluate salty taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors(high caries risk, medium caries risk, low risk )."
15923665|NCT03468946|Other|bitter taste perception|"bitter taste perception in high caries risk, medium caries risk, low caries risk.
~The aim of this study was to evaluate bitter taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors (high caries risk, medium caries risk, low risk )."
15923666|NCT03468946|Other|sour taste perception|sour taste perception in high caries risk, medium caries risk, low caries risk. The aim of this study was to evaluate sour taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors (high caries risk, medium caries risk, low risk ).
15923667|NCT03468946|Other|sweet taste perception|"sweet taste perception in high caries risk, medium caries risk, low caries risk.
~The aim of this study was to evaluate sweet taste perceptions of school children and compare them with demographic, clinical, microbiologic and biochemical caries-risk factors (high caries risk, medium caries risk, low risk )."
15923668|NCT03468933|Drug|tissue plasminogen activator (tPA) and human recombinant deoxyribonuclease (DNase)|Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 dose
15923669|NCT03468933|Procedure|Medical Thoracoscopy|Medical thoracoscopy will be performed as per standard protocols.
15923670|NCT03468920|Drug|IV Acetaminophen|IV Acetaminophen 1000mg in 100mL normal saline once pre-operatively
15923671|NCT03468920|Drug|PO Acetaminophen|Acetaminophen PO 1000mg once pre-operatively
15923672|NCT03468920|Drug|PO Placebo|PO placebo capsule compounded to match PO Acetaminophen capsule
15923673|NCT03468920|Drug|IV Solution Placebo|This will serve as the placebo for the IV Acetaminophen intervention
15923674|NCT03468907|Drug|Telbivudine 600mg|Pregnant mothers who opted for antiviral therapy would start on oral LDT 600 mg daily between gestational weeks 24 and 28.
15923675|NCT03468907|Drug|Tenofovir disoproxil fumarate 300mg|Pregnant mothers who opted for antiviral therapy would start on oral TDF 300 mg daily between gestational weeks 24 and 28.
15923676|NCT03468894|Behavioral|Treadmill desk walking|See intervention arm description
15923677|NCT03468881|Other|Communication Skills Training Package (KEW)|A training package (called KEW: Know, Encourage and Warm-up) for therapeutic radiographers to manage emotional talk with breast cancer patients in treatment.
15923678|NCT03468868|Behavioral|Exercise program for people with MS|The intervention consists of 30 minutes of resistance training and 30 minutes of cardio three times per week for 16 weeks.
15923679|NCT03468855|Drug|ATI-50002 topical solution|Topical Solution administered twice daily
15923680|NCT03468842|Biological|Probiotic|Already described
15923681|NCT03468842|Biological|Placebo|Placebo
15923682|NCT03468829|Biological|ALX-0171 Dose 1|Oral inhalation of ALX-0171 Dose 1 once daily for a maximum of 14 days
15923683|NCT03468829|Biological|ALX-0171 Dose 2|Oral inhalation of ALX-0171 Dose 2 once daily for a maximum of 14 days
15923684|NCT03468829|Biological|Placebo|Oral inhalation of Placebo once daily for a maximum of 14 days
15923685|NCT03468816|Device|Sensor activation (on DryMax Extra Soft)|Study profile of sensor activation
15923686|NCT03468803|Diagnostic Test|Beta D Glucan test|Measurement of BDG before, during and after surgery
15923687|NCT03468790|Drug|CMAB007|the study drug
15923688|NCT03468790|Drug|Symbicort|asthma-controlled drug
15923689|NCT03468790|Drug|Seretide|asthma-controlled drug
15923690|NCT03468790|Drug|Ventolin|asthma rescue drug
15923691|NCT03468790|Drug|placebo|No active components
15923692|NCT03468777|Drug|Lumicitabine|Participants will receive single oral dose of 1000 mg lumicitabine as per assigned treatment sequence.
15923693|NCT03468777|Drug|Lansoprazole|Participants will receive single oral dose of 30 mg lansoprazole capsule as per assigned treatment sequence.
15923694|NCT03468777|Drug|Ranitidine|Participants will receive single oral dose of 150 mg ranitidine as per assigned treatment sequence.
15923695|NCT03468764|Procedure|Vigileo monitoring during lung recruitment maneuver|"Standard monitoring parameters, invasive blood pressure and hemodynamic values (SVV and CO, through Vigileo device) will be monitored. With the patient in a supine position and as SVV reaches a value of 12-15%, a LRM is performed, consisting in the application of 30 cm H2O continuous positive airway pressure for 30 seconds.
~The alterations in the above mentioned parameters will be registered before and after the maneuver.
~The same procedure will be performed after a 8 ml/kg crystalloids fluid challenge, as soon as SVV reaches the value of 10%."
15923696|NCT03468751|Drug|HLX10|recombinant humanized anti-PD-1 monoclonal antibody against solid cancers
15923697|NCT03468738|Other|Blood transfusion|Transfusion of blood products in the perioperative period in patients undergoing major surgery
15923698|NCT03468725|Drug|XPF-008|Capsule filled with XEN1101
15923699|NCT03468725|Drug|Microcrystalline Cellulose|Placebo capsule
15924163|NCT03465280|Procedure|Plasma coagulation|Removal of lesions via plasma coagulation
15923700|NCT03468712|Procedure|Laparoscopic D2 distal gastrectomy|Laparoscopic D2 distal gastrectomy after 3-Cycle XELOX neo-adjuvant chemotherapy
15923701|NCT03468699|Combination Product|Autologous BMMC transplantation|Stem cell transplantation
15923702|NCT03468686|Device|Bilateral rTMS|The coil will locate on F3 and F4 in accordance with the 10-20 international system. bilateral rTMS include stimulate the right DLPFC at 1 Hz for a 10 seconds train of stimulation, and a total of 150 pulse trains. Immediately after that, the stimulation was carried out on the left DLPFC at 10 Hz, 5 seconds of stimulation, with 10 second inter-train interval and 75 pulse trains.
15923703|NCT03468686|Device|Sham rTMS|The same parameters will use in the sham rTMS. However, the coil adjust at an angle of 90º vertically on the skull in a way that one wing place on the head.
15923704|NCT03468686|Device|Unilateral rTMS (High frequency)|The coil will locate on F3 in accordance with the 10-20 international system. Unilateral rTMS include stimulate the Left DLPFC at 10Hz for a 5seconds train of stimulation, 10 seconds inter-train interval, and a total of 75 pulse trains. .
15923705|NCT03468660|Behavioral|Auditory training with feedback|Experimental group receives phoneme-level and sentence-level training with feedback
15923706|NCT03468660|Behavioral|Listening paradigm with no feedback|Active controls listen to acoustic stimuli with no feedback
15923707|NCT03468647|Other|soles|Volunteer must walk this this connected seamless to measure different walking parameters
15923708|NCT03468647|Other|weighting machine|This weighting machine measure weight evolution and equilibrate of volunteers
15923709|NCT03468647|Other|gripping force|this machine measure the gripping force of volunteer
15923710|NCT03468634|Diagnostic Test|endoscopy|Oesophageal endoscopy with biopsy
15923711|NCT03468621|Procedure|Wound closure|Method of wound closure
15923712|NCT03468595|Device|ultrasonic (Piezon Master 700) performed with Listerine|
15923713|NCT03468595|Device|ultrasonic (Piezon Master 700) performed with CHX|
15923714|NCT03468595|Device|ultrasonic (Piezon Master 700) performed with serum|
15923715|NCT03468582|Combination Product|123I radiolabeled 3BNC117|123I radiolabeled 3BNC117
15923716|NCT03468569|Other|Functional Movement Screen|
15923717|NCT03468556|Drug|SNP-610|Subjects will take 2 tablets once a day orally for 12 weeks
15923718|NCT03468556|Drug|Placebo Oral Tablet|Subjects will take 2 tablets once a day orally for 12 weeks
15923719|NCT03468543|Drug|Memantine Hydrochloride MR Prototype Capsule Formulation A|Memantine HCl MR capsule formulation will be administered orally in a single dose
15923720|NCT03468543|Drug|Memantine Hydrochloride MR Prototype Capsule Formulation B|Memantine HCl MR capsule formulation will be administered orally in a single dose
15923721|NCT03468543|Drug|Memantine Hydrochloride MR Prototype Capsule Formulation C|Memantine HCl MR capsule formulation will be administered orally in a single dose
15923722|NCT03468543|Drug|Memantine Hydrochloride MR Prototype Capsule Formulation D|Memantine HCl MR capsule formulation will be administered orally in a single dose
15923723|NCT03468543|Drug|Memantine Hydrochloride MR Prototype Capsule Formulation E|Memantine HCl MR capsule formulation will be administered orally in a single dose
15923724|NCT03468543|Procedure|Magnetic Resonance Imaging|MRI will be performed on specified days according to protocol
15923725|NCT03468530|Procedure|Transurethral ablation|transurethral resection and/or coagulation with a bipolar loop under spinal or general anesthesia
15923726|NCT03468517|Other|Bathe method:|BATHE technique, on the other hand, is one of the short therapeutic consultation techniques that strengthen the doctor-patient relationship. BATHE stands for the initials of the questions that include the titles for Background, Affect, Trouble, Handling and Empathy. It allows evaluating the physiological stress of the patients quickly. BATHE method necessitates an empathetic expression that includes the view of the patient in addition to asking the key questions by the doctor doing the interview
15923727|NCT03468504|Device|Mirror Therapy|Participants view the reflective side of a simple mirror which is placed in their mid-sagittal plane to view a mirror reflection of their non-affected limb for 30 mins per day, 3 days per week, for four weeks.
15923728|NCT03468504|Device|Placebo Mirror Therapy|"Placebo Mirror Therapy: Participants view the reflective side of a simple mirror which is placed forward/ahead of them in their mid-sagittal plane, and thus cannot see a reflection of either lower limb as their leg does not pass in front of the mirror for 30 mins per day, 3 days per week, for four weeks.
~Treadmill Training: Participants will walk on a treadmill at their comfortable walking speed for 30 mins per day, 3 days per week, for four weeks."
15923729|NCT03468504|Device|Treadmill|Participants will walk on a treadmill at their comfortable walking speed for 30 mins per day, 3 days per week, for four weeks.
15923730|NCT03468491|Other|combined training|The whole intervention period will last for 6 weeks, 2 visits per week, 1 hour per visit in the Research Building Room 630 of National Yang Ming University. All programs will be under the supervision of a physiotherapist with 2-year experience individually. 1. Hallux valgus correction: 1.1 Joint alignment correction (Grade II joint mobilization, 10 times/set, 3 sets/visit) - 1st MTP joint distraction - Proximal talofibular joint anteroposterior glide - (Grade III joint mobilization if any restriction being found) 1.2 Biomechanical taping (using Dynamic taping, 1 time/ visit, keep the taping for 2 days minimum) 1.3 Foot intrinsic muscle strengthening (10 times/set for each exercise, 3 sets/visit): - Short foot exercise - Toespread out exercise - Heel-rise exercises 2. Lower extremity neuromuscular exercises: (10-15 times/set, 3 sets/visit) 2.1 Single lunge 2.2 Stepping down 2.3 Vertical squat 2.4 Vertical jumping
15923731|NCT03468491|Other|Proximal training|1. Lower extremity neuromuscular exercises: (10-15 times/set, 3 sets/visit) 1.1 Single lunge 1.2 Stepping down 1.3 Vertical squat 1.4 Vertical jumping All exercises will first start on firm surface without additional resistance/weight. Later, settings will be gradually shifted into on firm surface with resisted band from random direction, on a cushion with/ without resisted band, on a BOSU balance trainer. Progression are made every 2 weeks ideally, while adjustments may be taken into concern due to individual differences.
15923732|NCT03468478|Drug|Sirolimus|sirolimus combined to reduced dose of tacrolimus
15923733|NCT03468478|Drug|Everolimus|everolimus combined to reduced dose of tacrolimus
15923734|NCT03468478|Drug|Mycophenolic acid|Control arm: mycophenolate combined to regular tacrolimus
15923735|NCT03468465|Drug|Solifenacin Succinate|10 mg tablet daily during 75 days maximum
15924164|NCT03465280|Procedure|Other|Removal of lesions via other methods
15923736|NCT03468465|Device|Neuro-Muscular Stimulators (NMS)|Treatment with T-PTNS will include a first induction period of 4 weeks with daily sessions of 30 minutes duration and performed at each subject's home (Monday through Friday, resting weekends) and a second recall period of 2 additional months, with a session every 4 weeks that will be held at the healthcare center. In total there will be 20 sessions in the induction period and 2 in the recall period
15923737|NCT03468452|Other|extubation|Time of extubation
15923738|NCT03468439|Other|Femoral nerve block with phenol|
15923741|NCT03468413|Drug|CP1050 or Placebo|Randomised, double-blinded, placebo-controlled
15923742|NCT03468387|Procedure|Primary realignment|Endoscopic realignment of rupture urethra over a urethral catheter
15923743|NCT03468387|Procedure|Suprapubic cystostomy|Percutaneous cystostomy catheter will be inserted under sonographic guidance
15923744|NCT03468374|Device|lymphoscintigraphy|Nuclear Medicine diagnostic device using radioactive material
15923745|NCT03468374|Device|Single Photon Emission Tomography|Nuclear Medicine diagnostic device using fusion technique between SPECT and CT
15923746|NCT03468361|Other|Natural Product Petroselinum crispum (Parsley)|Parsley herb, in fresh form will be obtained from the local market available. The herb will be properly washed with distilled water and dried properly for 10 to 15 days under shade in the lab. Soft gelatin capsules will be filled with parsley powder (dried herb) in amount normally recommended in daily routine (1g) will be administered to patients once daily.
15923747|NCT03468361|Other|Placebo|Soft gelatin capsules will be filled with 1 gram of lactose (inert pharmaceutical ingredient) and will be administered to patients once daily.
15923748|NCT03468348|Drug|Duloxetine|patients scheduled for mastectomy and axillary evacuation for cancer breast will receive orally, 2 hours before the operation either, placebo capsule, duloxetine 30 mg,duloxetine 60 mg or duloxetine 90 mg capsule.
15923749|NCT03468335|Drug|Irinotecan Liposomal Injection [Onivyde]|"Cancer treatment for PDAC:
~Nal-IRI (4.3 mg/ml) 70 mg/m2 as 1.5 hour infusion
~5-FU 2400 mg/m2 as 46 hour infusion
~Folinic acid 400 mg/m2 as 0.5 hour infusion
~all on D1 of each cycle; Cycle q2w ± 5 days
~Treatment until progressive disease or intolerable toxicity or withdrawal of consent."
15923750|NCT03468322|Drug|AC-203|The investigational product is formulated as 1% topical ointment
15923751|NCT03468322|Drug|Vehicle|Vehicle-only control study medication is the same formulation as investigational product without active ingredient
15923752|NCT03468309|Genetic|Genecept Assay and G-DIG decision tool|Participating providers will review results of the Genecept Assay using a secure web-based program and will utilize the G-DIG tool in order to determine the optimal medication regime for the patient, based on their individual genetic profile. Genomind will provide training to all investigators prior to the study start regarding the interpretation of the pharmacological assay and the use of the G-DIG tool. Genomind representatives will be available throughout the duration of the study for consultation regarding the interpretation and implementation of the testing results. All final decisions about changing dosage, adding medications, or removing medications will be determined by the provider.
15923753|NCT03468296|Drug|Intravitreal Aflibercept Injection 2mg|Aflibercept is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration.
15923754|NCT03468283|Other|mobile application for diabetes|Intervention was mobile application and individualized regular message feedback sent by healthcare professionals.
15923755|NCT03468257|Behavioral|Pavlovian Conditioning|Imagining a stressful event, engaging in progressive muscle relaxation, and eating fruit
15923756|NCT03468244|Biological|Personalized mRNA Tumor Vaccine|subcutaneous injection with personalized mRNA tumor vaccine at least four times
15923757|NCT03468231|Drug|Sorafenib|Oral Sorafenib, 400mg, Bid
15923758|NCT03468231|Drug|HAIC of FOLFOX|administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
15923759|NCT03468231|Drug|HAIC of OXA|administration of Oxaliplatin via the tumor feeding arteries
15923760|NCT03468218|Drug|Cabozantinib|Given PO
15923761|NCT03468218|Biological|Pembrolizumab|Given IV
15923762|NCT03468192|Other|Non-precaution group|Patients in the NPG had no restrictions on mobility, i.e. they were encouraged to move freely during the recovery phase and assistive equipment were prescribed only if needed
15923763|NCT03468179|Dietary Supplement|Oatmeal|Subjects will be fed a calculated serving of oatmeal.
15923764|NCT03468166|Other|Chronic stroke|The data for motor function and gait pattern analysis was obtained.
15923765|NCT03468153|Biological|Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy|Patient-derived dual specificity CD19 and CD22 CAR-T Cells
15923766|NCT03468140|Drug|Eculizumab|Eculizumab will be given at a dose of 1200mg diluted in 0.9% sodium chloride (NaCl) to 5mg/mL for a total volume of 240 mL administered by IV infusion over 25-45 minutes in the anhepatic-phase during the transplant procedure, and a second dose of 900mg diluted in 0.9% NaCl to 5mg/mL for a total volume of 180 mL administered by IV infusion over 25-45 minutes will be given 24 hours following the first dose.
15923767|NCT03468140|Other|No intervention|Historical control arm
15923768|NCT03468127|Other|Soy foods|Isolated soy protein, soy protein, soybean products, soy milk
15923769|NCT03468114|Behavioral|Safe Start|Participant households will receive four visits over a 10 week period from health extension workers promoting safe food preparation, storage and feeding, and will be provided with products to support these practices (a bowl, spoon, cup, hand washing station, liquid soap dispenser).
15923770|NCT03468114|Behavioral|Active Control|Participant households will receive 4 visits by health extension workers delivering standard care
15923771|NCT03468101|Other|Pulmonary Function Testing|Pulmonary Function Testing, Cardiopulmonary exercise testing, 6 Minute walk test, Thoracic CT
15923772|NCT03468088|Behavioral|Hand grip strengthening|Handgrip strengthening exercises will be added to the experimental group. This exercise is chosen based on literature review of EMG and biomechanical studies. Adjustable heavy grip hand gripper will be used as handgrip resistance at 10 repetitions maximum (RM). The exercise will be performed in standing position the patient's back will be rested in a wall, arm at 30º abduction, 60º abduction 90º abduction & with 90º ER. In this positions, the patient will be performed 3 sets of 10 squeezes each at a 1-minute interval.
15923773|NCT03468088|Behavioral|Conventional treatment|Ultrasound therapy will be used to treat both groups. Ultrasound will be applied; while the patient will be seated in an adjustable chair with back support, feet on the floor. The chair will be positioned beside a table. The patient's shoulder will be rested on the table beside the body and elbow will be flexed at 90°. A round-headed probe will be used that is put in direct contact with the patient's skin over the shoulder joint. Ultrasound gel will be used on all surfaces of the head in order to reduce friction and assist in the transmission of the ultrasonic waves.
15923774|NCT03468075|Drug|Ascorbate|Following 15g test dose, 75g administered on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle
15923775|NCT03468075|Drug|Gemcitabine|Administered on Days 1, 8 and 15, after the infusion of ascorbate
15923776|NCT03468062|Drug|Dexmedetomidine|Patients assigned in Dexmedetomidine or Placebo group are given Dexmedetomidine or normal saline after induction of anesthesia.
15923777|NCT03468049|Biological|Topical App. of Allium Cepa Extract|Topical Application of Allium Cepa Extract (oil)
15923778|NCT03468049|Biological|Phonophoresis of Allium Cepa Extract|Phonophoresis of Allium Cepa Extract (oil)
15923779|NCT03468049|Biological|Raw Mashed Allium Cepa Application|Raw Allium Cepa (onion bulb) Mashed
15923780|NCT03468049|Other|Standard Physiotherapy Group (SPG)|This will consist of Massage and therapeutic exercise for the management of shoulder pain post stroke
15923781|NCT03468036|Other|none, does not apply|none: does not apply
15923782|NCT03468023|Procedure|Short arm cast|Application of a below-elbow cast
15923783|NCT03468023|Procedure|Long arm cast|Application of an above-elbow cast
15923784|NCT03468010|Radiation|chemoradiation|radiation with concurrent ciplatin
15923785|NCT03468010|Drug|Paclitaxel, Cisplatin|The regimen of additional adjuvant chemotherapy following radiation is Paclitaxel, Cisplatin once 3 weeks.
15923786|NCT03467997|Behavioral|Trier social stress test|Subjects are asked to give a 5 minute speech on a topic selected by the investigator. Then they are asked to subtract 7 from 758.
15923787|NCT03467997|Other|Diesel exhaust|Diesel exhaust is an air pollutant found in the environment and produced by cars, trucks and other transportation modes (e.g. trains, planes).
15923788|NCT03467984|Biological|LBVE|Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
15923789|NCT03467984|Biological|Prevnar13|13-valent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
15923790|NCT03467971|Drug|Metformin/Gliclazide Fixed Combination|Participants will receive single oral dose of Metformin 1000 mg and Gliclazide 30 mg fixed combination tablet in fasting or fed state.
15923791|NCT03467958|Drug|Ozanimod|Ozanimod
15923792|NCT03467945|Drug|Metformin/Gliclazide Fixed Combination|Participants received single oral dose of Metformin and Gliclazide fixed combination tablet in treatment period 1, 2, 3 or 4.
15923793|NCT03467945|Drug|Metformin|Participants received single oral dose of Metformin tablet in treatment period 1, 2, 3 or 4.
15923794|NCT03467945|Drug|Gliclazide|Participants received single oral dose of Gliclazide tablet in treatment period 1, 2, 3 or 4.
15923795|NCT03467932|Drug|Cohort A: ORMD-0801|"Part 1 In the first two weeks of active treatment (Part 1) subjects will receive double-blind therapy according to their randomized regimen (placebo or ORMD-0801) to be taken QHS, BID or TID. Subjects will undergo a step-wise dose escalation from a starting dose of 16 mg (Visit 3), to 24 mg (Visit 4), to a top dose of 32 mg (Visit 5 onward). Subjects will then enter Part 2.
~Part 2:
~During Part 2, subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia."
15923796|NCT03467932|Drug|Placebo oral capsule|Placebo provided QHS, BID, TID
15923797|NCT03467932|Drug|Cohort B: ORMD-0801|"Part 1 In the first two weeks of active treatment, subjects will receive double-blind therapy according to their randomized regimen (ORMD 0801 8 mg or 16 mg, or matched placebo) to be taken QHS or BID. Subjects will then enter Part 2 at the same dose and regimen administered in Part 1.
~Part 2 Subjects will remain on fixed doses of ORMD-0801 (or matched placebo) for 10 weeks. Doses will not be adjusted unless clinically indicated for adverse events or hypoglycemia."
15923798|NCT03467919|Procedure|Micro Fragmented Adipose Tissue|Harvesting of Micro Fragmented Adipose Tissue with intra-articular injection
15923799|NCT03467919|Procedure|Corticosteroid injection|Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.
15923800|NCT03467906|Other|In-laboratory assessment|Participants will stay in the laboratory for two days and one night during which they will complete questionnaires, have blood drawn, and have other measurements taken.
15923801|NCT03467893|Drug|Antacids|number aof antacids treatment after PPI stop
15923802|NCT03467880|Other|Clinical Observation|No treatment given but observation with IOS
15923803|NCT03467867|Drug|Venetoclax|Venetoclax will be administered as described in the reporting arm.
15923804|NCT03467867|Drug|Rituximab|Rituximab (IV) will be administered as described in the reporting arm.
15923805|NCT03467867|Drug|Rituximab/Hyaluronidase Human|Rituximab/Hyaluronidase Human (SC) ill be administered as described in the reporting arm.
15923806|NCT03467841|Device|CMV IgM, IgG in blood real time PCR for serum CMV DNA .|Colonoscopic examination will be done for all studied patients after standardbowel preparation using a Pentax videoscope to= Assess the endoscopic lesions using Mayo endoscopic subscore
15923807|NCT03467828|Genetic|polymorphism analyzing|Blood samples will be taken to EDTA containing tubes and then will be analyzed for genetic polymorphisms.
15923808|NCT03467802|Biological|enamel matrix derivative|Enamel matrix derivative (EMD), sold under the brand name Emdogain®, is an amelogenin derivative of embryonal porcine enamel and is FDA approved for application to root surfaces to treat recession defects. Amelogenins comprise the majority of the proteins in EMD while others such as tuftelin, ameloblastin and amelin make up the remainder. EMD is thought to mimic the role of proteins crucial to cementogenesis and root development, which may promote new gingival attachment to exposed roots. The properties of EMD may favor early healing of the soft tissue and stimulate angiogenesis.
15923882|NCT03467373|Drug|Vincristine|Vincristine 1.4 mg/m^2 administered by IV push on Day 1 of each 21-day cycle with a recommended cap of 2 mg
15923883|NCT03467373|Drug|Prednisone|Prednisone 100 mg/day orally on Days 1-5 (prednisone on Day 1 may be administered IV, with the remaining doses on Days 2-5 to be administered orally) of each 21-day cycle
15923809|NCT03467802|Device|Porcine collagen matrix|Mucograft® is a bi-layered grafting material composed of Type I and III collagen. It is derived from veterinary certified pigs, sterilized by gamma irradiation and has a low antigenicity in conjunction with good biocompatibility. The material is approximately 2.5-5mm thick and is indicated for root coverage, increasing keratinized tissue, covering of implants placed immediately and alveolar ridge reconstruction. A compact outer layer contributes to protection, structure and allows for better control during suturing; while the inner layer is thick, porous and spongy in nature, providing a suitable environment for early vascularization and promotion of cellular in-growth.
15923810|NCT03467789|Drug|Dietary Vitamin D3 pre-treatment|The daily dose of D3 will always be 10,000 IU/day. Total amounts of D3 supplementation given will be adjusted, based upon serum 25-hydroxy-D3 levels found at baseline. Duration of pretreatment will be 14 days if the D3 level is < 31 ng/mL, and 5 days if the D3 level is > 31 ng/mL
15923811|NCT03467789|Radiation|Photodynamic therapy|Photodynamic Therapy (PDT) is an experimental technique that works by combining a photosensitizing topical agent and an intense light source to kill tumor cells.
15923812|NCT03467789|Drug|Serum Maintenance Vitamin D3|2,000 IU/d for adults, 1,000 IU/d for children taken after third visit.
15923813|NCT03467763|Drug|Metformin Extended Release Oral Tablet|Metformin hydrochloride extended release tablets in dosages of 250 mg, 500 mg, 750 mg, and 1,000 mg. Individual encapsulations of metformin will contain dosages of 250 mg or 500 mg.
15923814|NCT03467763|Drug|Placebo oral capsule|Placebo capsule
15923815|NCT03467750|Drug|Ketorolac|Patients in this group will receive 0.5mg/kg of ketorolac, administered intravenously.
15923816|NCT03467750|Drug|Standard of Care|"All patients will undergo inhalational induction with nitrous oxide and sevoflurane. After intravenous (IV) placement, 1-3mg/kg of propofol and 1mcg/kg of fentanyl will be administered. After induction, 0.5mg/kg of dexamethasone and an IV infusion of 15mg/kg of acetaminophen will be administered. During surgery, 0.5mcg/kg of dexmedetomidine and 0.1mg/kg ondansetron will be given.
~A rescue dose of 0.5-1mcg/kg of IV Fentanyl will be available for use at the end of the procedure. The decision to administer will be left to the discretion of the attending anesthesiologist. The choice to give this will be made based on variables including patient's condition and a 20% increase in the heart rate and blood pressure.
~The PACU nurses, who will be blinded to ketorolac administration, will evaluate the patients using FLACC scores. For patients with a FLACC score of 6-10, morphine 0.05mg/kg will be administered. For patients with FLACC scores of 3-5, morphine 0.025mg/kg will be administered."
15923817|NCT03467737|Other|Normal sorghum porridge, algal starch|Normal sorghum porridge with 13C-labeled algal starch was fed, breath tested, as the first arm of an alpha-amylase sufficiency assessment in healthy and moderately malnourished children.
15923818|NCT03467737|Other|Normal sorghum porridge, algal dextrins|Normal sorghum porridge with 13C-labeled starch limit dextrins was fed, breath tested, as the second arm of an alpha-amylase sufficiency assessment in healthy and moderately malnourished children.
15923819|NCT03467737|Other|Normal sorghum porridge, labeled flour|Normal sorghum porridge with a portion of 13C-labeled sorghum flour was fed, breath tested, for starch digestibility assessment in healthy and moderately malnourished children.
15923820|NCT03467737|Other|Modified sorghum porridge, labeled flour|Modified sorghum porridge with shear stirring to reduce viscosity with a portion of 13C-labeled sorghum flour was fed, breath tested, for starch digestibility assessment in healthy and moderately malnourished children.
15923821|NCT03467737|Other|Thinned sorghum porridge, labeled flour|Thinned sorghum porridge treated with an alpha-amylase liquifying enzyme with a portion of 13C-labeled sorghum flour was fed, breath tested, for starch digestibility assessment in healthy and moderately malnourished children.
15923822|NCT03467737|Other|Modified sorghum porridge, octanoic acid|Modified sorghum porridge with shear stirring to reduce viscosity with addition of 13C-labeled octanoic acid was fed, breath tested, for gastric emptying assessment in healthy and moderately malnourished children.
15923823|NCT03467724|Device|fractional radiofrequency|Fractional radiofrequency will be delivered to the area of the surgical scar identified to receive the study treatment.
15923824|NCT03467711|Other|tidal volume challenge|transiently increasing tidal volume from 6 to 8 mL/kg predicted body weight (tidal volume challenge)
15923825|NCT03467711|Other|volume expansion|give 6ml/kg (predicted body weight) volulyte for 10min
15923826|NCT03467698|Device|Active tDCS|Real stimulation
15923827|NCT03467698|Device|Sham tDCS|Sham stimulation
15923828|NCT03467685|Device|Vibratory Anesthetic Device (VAD)|This is a handheld ~10cm long tool, battery operated, which provides vibration at a rate of ~150 Hz
15923829|NCT03467672|Other|Diagnosis of bacterial infection|use of eosinopenia in the diagnosis of bacterial infection
15923830|NCT03467659|Other|Cracked whole wheat porridge|Large particle whole wheat porridge was tested for gastric emptying rate, glycemic response and appetitive response.
15923831|NCT03467659|Other|Semolina wheat porridge|Large particle refined wheat porridge was tested for gastric emptying rate, glycemic response and appetitive response.
15923832|NCT03467659|Other|Whole wheat flour porridge|Small particle whole wheat porridge was tested for gastric emptying rate, glycemic response and appetitive response.
15923833|NCT03467659|Other|Refined wheat flour porridge|Small particle refined wheat porridge was tested for gastric emptying rate, glycemic response and appetitive response.
15923834|NCT03467659|Other|Refined wheat flour porridge,fine bran|Small particle refined wheat porridge with small particle bran was tested for gastric emptying rate, glycemic response and appetitive response.
15923835|NCT03467659|Other|Refined wheat flour porridge,coarse bran|Small particle refined wheat porridge with large particle bran was tested for gastric emptying rate, glycemic response and appetitive response.
15923836|NCT03467646|Procedure|Sleeve Gastrectomy|The patients undergo a Sleeve Gastrectomy as bariatric procedure
15923837|NCT03467646|Procedure|Roux-en-Y gastric bypass|The patients undergo a Roux-en-Y gastric bypass as bariatric procedure
15923838|NCT03467646|Procedure|One-Anastomosis Gastric Bypass|The patients undergo a One-Anastomosis Gastric Bypass as bariatric procedure
15923884|NCT03467360|Drug|acetazolamide in combination with platinum and etoposide-based radiochemotherapy|Radiation therapy will be combined with platinum and etoposide-based chemotherapy combined with 3-6 tablets per day of acetazolamide during the entire course of therapy (dosage appropriate to the inclusion phase).
15924165|NCT03465280|Other|Adjuvant therapies|All adjuvant therapies
15923839|NCT03467633|Behavioral|High-intensity interval training|Participants in the HIIT group will receive 3-weeks of tri-weekly supervised exercise sessions at the UOHI prior to their scheduled electro-cardioversion. The session will last 23 minutes in duration and consist of a 2-minute warm-up at 50% of peak power output (PPO), 2 x 8-minute interval training blocks of 30 seconds at 80-100% of PPO interspersed with 30-seconds of active recovery and a 1-minute cool down at 25 % of PPO. The sessions will be lead by a Registered Kinesiologist.
15923840|NCT03467620|Drug|Cannabidiol|Administration of one oral 25-mg capsule of Cannabidiol daily for a duration of 12 weeks
15923841|NCT03467620|Drug|Placebo oral capsule|Administration of one oral placebo capsule daily for a duration of 12 weeks
15923842|NCT03467607|Procedure|tidal volume ventilation|low tidal volume ventilation
15923843|NCT03467594|Behavioral|High-intensity interval training|• Exercises will be conducted in an interval training format (60 second exercise bursts, followed by 75 seconds rest). The exercise bursts are designed to elicit ≥85% of participants age predicted maximum heart rate and will be tailored to each individuals fitness level and ability. Exercise sessions will be conducted 3 times per week for 8 weeks and will last between 15-25 minutes.
15923844|NCT03467568|Dietary Supplement|Sodium Chloride|300mg sodium chloride will be provided in a capsule
15923845|NCT03467568|Other|Placebo capsule|A capsule of identical appearance to that providing salt, but not containing electrolytes, will be consumed
15923846|NCT03467568|Dietary Supplement|Water|Twice during the morning a drink of 150ml of water will be consumed
15923847|NCT03467568|Biological|No water consumed|No water will be consumed during the monring
15923848|NCT03467555|Device|Class II correction using miniplates in zygomatic region|
15923849|NCT03467542|Device|PHIL® Liquid Embolic System|The PHIL Embolic System is indicated in the treatment of dural arteriovenous fistulas (DAVF)
15923850|NCT03467529|Other|Non interventional study|Non interventional study
15923851|NCT03467516|Biological|Tumor Infiltrating Lymphocytes (TIL)|TIL infusion intravenously through a central vein catheter over 20-30 minutes. Folowed by Aldesleukin, administered at a dose of 600,000 IU/kg (based on total body weight) as an intravenous bolus over a 15-minute period approximately every 8 hours beginning within 24 hours of TIL infusion and continuing for up to a maximum of 6 doses.
15923852|NCT03467503|Dietary Supplement|Blueberry + soluble fiber|Dietary frozen blueberries and soluble fiber for 20 weeks
15923853|NCT03467490|Behavioral|DED self-management|This an educational intervention. The interventional will include watching a series of short videos and a DED handbook. The short videos will address the following topics: anatomy of the eye, pathophysiology of DED, treatment options for DED, management of DED with allergies/glaucoma/ computer use, and new developments in treatment and research of dry eye disease. The handbook will include tools and resources for self management of DED.
15923854|NCT03467477|Drug|Flortaucipir F18|370 megabecquerel (MBq) IV single-dose
15923855|NCT03467477|Procedure|Brain PET Scan|positron emission tomography (PET) scan of the brain
15923856|NCT03467464|Other|Eye Movement Desensitization and Reprocessing (EMDR)|The intervention consists of 10 weekly EMDR sessions of 60 minutes and targets stressful daily life (i.e. a situation that caused anger, fear or confusion) events rather than traumatic images from the past. For each session, a standardised EMDR protocol is used that consists of the following consecutive steps: 1) determining and visualising a confusing and/or stressful daily life event that occurred during the past week; 2) formulating a negative and a positive thought based on the chosen event; 3) determining the amount of stress that is evoked by the chosen event; 4) patient focuses on the chosen event while being presented with a distracting stimulus; 5) evaluating the amount of stress that is caused by the chosen event; 6) linking positive thoughts to the negative one when the stress caused by the chosen event does no longer exist; 7) evaluation and closure of session.
15923857|NCT03467451|Procedure|Endoscopic Mucosectomy|Endoscopic Mucosectomy with anchorage of the tip of the loop
15923858|NCT03467438|Drug|Zinc-l-carnosine|Patients will be asked to take the investigational product as already mentioned (blindly).
15923859|NCT03467438|Other|Placebo|Patients will be asked to take placebo as already mentioned (blindly).
15923860|NCT03467425|Drug|FF/UMEC/VI|FF is a dry white powder containing 100 mcg GW685698 blended with lactose in one blister in the first strip of the DPI. UMEC/VI is a dry white powder containing 62.5 mcg of UMEC and 25 mcg of VI per blister, both blended together with lactose and magnesium stearate in the second strip of the DPI.
15923861|NCT03467425|Drug|Inhaled Corticosteroid|Inhaled Corticosteroid (ICS) as prescribed by the physician.
15923862|NCT03467425|Drug|LAMA|LAMA as prescribed by the physician.
15923863|NCT03467425|Drug|LABA|LABA as prescribed by the physician.
15923864|NCT03467425|Drug|COPD rescue medications|Rescue medications for COPD will be prescribed and obtained according to usual practice.
15923865|NCT03467412|Drug|FOL-005|intradermal injection
15923866|NCT03467412|Drug|Placebo|intradermal injection
15923867|NCT03467399|Device|Nucleus 7 Cochlear Implant System|A new cochlear implant sound processor system.
15923868|NCT03467386|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo alloHCT
15923869|NCT03467386|Drug|Cyclophosphamide|Given IV
15923870|NCT03467386|Biological|Filgrastim|Administer according to City of Hope standard operating procedures
15923871|NCT03467386|Other|Laboratory Biomarker Analysis|Correlative studies
15923872|NCT03467386|Other|Quality-of-Life Assessment|Ancillary studies
15923873|NCT03467386|Other|Questionnaire Administration|Ancillary studies
15923874|NCT03467386|Drug|Tacrolimus|Given CIV
15923875|NCT03467386|Radiation|Total Marrow Irradiation|Undergo TMLI
15923876|NCT03467373|Drug|Glofitamab|Glofitamab will be administered intravenously (IV) as a step-up dose for Cycle 2 on Days 8 and 15, and as a single dose from Cycle 3 onwards.
15923877|NCT03467373|Drug|Obinutuzumab (G)|Obinutuzumab 1000 mg single dose IV infusion on Day 1 of Cycle 1 only
15923878|NCT03467373|Drug|Rituximab (R)|Rituximab will be administered as an IV infusion at a dose of 375 mg/m^2 on Day 1 of each 21-day cycle starting from Cycle 1 to Cycle 6 (Part 1) or from Cycles 1-6 (up to 8) (Part 2: DLBCL R-CHOP).
15923879|NCT03467373|Drug|Tocilizumab|Tocilizumab will be administered as an IV infusion as per the methods described in the Summary of Product Characteristics (SmPC) or other similar local prescribing documents. Tocilizumab will be given as rescue medication.
15923885|NCT03467347|Drug|VR: 200 mg DPV + 320 mg LNG|One silicone elastomer vaginal ring (VR) containing the active ingredients dapivirine (DPV) and levonorgestrel (LNG), formulated as IPM VR: 200 mg DPV + 320 mg LNG (Ring-102)
15923886|NCT03467334|Dietary Supplement|B. breve|Bifidobacterium probiotic strain at 1E+08 cfu/day
15923887|NCT03467334|Dietary Supplement|B. breve plus L. fermentum|Probiotic combination at 2E+08 cfu/day
15923888|NCT03467334|Drug|Simethicone 20 MG|Standard treatment for infant colic
15923889|NCT03467321|Other|Physical characteristic assessment|Physical characteristics related to balance, pulmonary function and low back pain were evaluated
15923890|NCT03467308|Genetic|Markers in tissue samples: (TIGAR , TRIM59, P53, AKT, GSH)|"The followings markers will be investigated in tissue samples:
~TIGAR expression using quantitative real-time polymerase chain reaction (q Rt PCR) and immunohistochemistry.
~TRIM59 expression using quantitative real-time polymerase chain reaction (q Rt PCR) and immunohistochemistry.
~P53 expression using immunohistochemistry. P53 nuclear localization is essential for its normal function in growth inhibition or induction of apoptosis.
~Akt expression using western blot.
~GSH using chemical methods."
15923891|NCT03467295|Procedure|Surgery|For patient in surgically treated group, surgical removal of intracerebral CMs by craniotomy is performed according to the principles as follows: less transgression of normal brain tissue; identification and protection of eloquent brain tissue; sparing associated developmental venous anomaly; hemosiderin rim resection for non-eloquent and superficial CMs and sparing yellowish tissue for eloquent and deep ones; Extended resections (mesial resection, standard temporal lobe resection) are recommend for epileptogenic CMs based on intra-operative EEG.
15923892|NCT03467295|Procedure|Observation|Observation is performed in conservatively treated patients with best medicine and supportive treatment, such as antiepileptic drugs, analgesic drugs and neurotrophic drugs. For patients with underlying diseases such as hypertension, hyperlipidemia or diabetes mellitus, after consulting with the relevant experts, the patients can be treated accordingly.
15923893|NCT03467282|Dietary Supplement|Probiotic|1g probiotic mix (twice day): Lactobacillus acidophilus 1x109 CFU + Bifidobacterium lactis 1x109 CFU + Lactobacillus rhamnosus 1x109 CFU + Lactobacillus paracasei 1x109 CFU
15923894|NCT03467282|Dietary Supplement|Placebo|1g polydextrose/maltodextrin - twice day
15923895|NCT03467269|Diagnostic Test|Brush sign|presence of a brush sign in MRI image in acute cerebral ischaemia
15923896|NCT03467256|Biological|Chimeric Antigen Receptor T-Cell Therapy|anti-CD19 chimeric antigen receptor - transduced T-cell given IV
15923897|NCT03467256|Drug|Fludarabine|given IV
15923898|NCT03467256|Drug|Cyclophosphamide|given IV
15923899|NCT03467256|Drug|Tocilizumab|given IV
15923900|NCT03467243|Behavioral|Cognitive Behavioral Social Skills Training|CBSST is a more recovery-oriented psychosocial rehabilitation intervention that helps Veterans with SMI set goals, correct errors in thinking, and build communication skills to improve social functioning
15923901|NCT03467243|Behavioral|Social Skills Training|SST is an evidence-based, manualized, goal setting curricula that teaches social skills, for example: communication skills and listening skills for Veterans with Serious mental Illness.
15923902|NCT03467243|Behavioral|Treatment as usual|TAU is when Veterans continue to receive their usual care.
15923903|NCT03467230|Device|NoL Index|Use of the PMD-200 in an observational study
15923906|NCT03467191|Drug|Alcohol|target BAC .08%
15923907|NCT03467191|Other|Placebo|placebo beverage
15923908|NCT03467178|Drug|Decitabine|Nucleic Acid Synthesis Inhibitor
15923909|NCT03467178|Drug|Carboplatin|Chemotherapy medication
15923910|NCT03467178|Drug|Pegylated Liposomal Doxorubicin|Chemotherapy medication
15923911|NCT03467178|Drug|Gemcitabine|Chemotherapy medication
15923912|NCT03467178|Drug|Paclitaxel|Chemotherapy medication
15923913|NCT03467165|Device|MRgFUS treatment|MRgFUS treatment of pain caused by trapeziometacarpal OA (and/or scaphotrapezial OA)
15923914|NCT03467165|Device|MRgFUS treatment|MRgFUS treatment of pain caused by hip OA
15923915|NCT03467152|Drug|E2027|Oral hypromellose capsules.
15923916|NCT03467152|Drug|Placebo|Oral hypromellose capsules.
15923917|NCT03467139|Other|Abdominal breathing exercise|Deep Breathing Exercise
15923918|NCT03467113|Drug|ZX008 0.2 to 0.8 mg/kg/day|ZX008 drug is an oral aqueous solution of fenfluramine hydrochloride. The product is sugar free.
15923919|NCT03467113|Drug|Cannabidiol|Cannabidiol
15923920|NCT03467100|Drug|XEN901|Capsule filled with XEN901
15923921|NCT03467100|Drug|Inert Ingredients Oral Product|Placebo capsule
15923922|NCT03467087|Device|Myopuls 2000D|Device: Myopuls 2000D (Curatec Services GmBH, 47443 Moers, Germany)
15923923|NCT03467074|Biological|influenza A/B vaccine|Regardless of the study enrollment, a two-time influenza vaccination at the start of the flu season is recommended every 4 weeks for all patients after stem cell transplantation. The vaccine is a trivalent inactivated non-adjuvanted influenza virus vaccine containing two influenza A viruses: pandemic H1N1, and H3N2, and an influenza B virus
15923924|NCT03467061|Dietary Supplement|Nitrate-rich beetroot juice|concentrated beetroot juice
15923925|NCT03467061|Dietary Supplement|Nitrate-depleted beetroot juice|concentrated beetroot juice
15923926|NCT03467061|Other|Mouthwash|2 x 10 mL antibacterial mouthwash per day for 14 days
15923927|NCT03467048|Device|McGrath videolaryngoscopy|"Intubations will be performed with a regular endotracheal tube of adequate diameter, usually 7.5 mm or 8.0 mm. Endotracheal tubes will be equipped with a hockey-stick-shaped stylette, which will be prepared by the anesthesiologist in advance.
~The McGrath or the Macintosh blade will be introduced into oral cavity according to manufacturer recommendations and clinical practice. Minor airway manipulation procedures including BURP or Sellick maneuvers will be allowed to improve visualization of the vocal cords."
15923960|NCT03466762|Other|Non applicable|Non applicable
15923961|NCT03466749|Device|Paclitaxel Eluting Balloon Catheter|Paclitaxel Eluting Balloon Catheter
15923962|NCT03466736|Diagnostic Test|[18F]flutemetamol PET scan|Each subject will receive an amyloid PET scan with [18F]flutemetamol
15924190|NCT03465020|Other|Observation|Safety and efficacy outcomes of patients on different treatments
15923928|NCT03467048|Device|Direct laryngoscopy|"Intubations will be performed with a regular endotracheal tube of adequate diameter, usually 7.5 mm or 8.0 mm. Endotracheal tubes will be equipped with a hockey-stick-shaped stylette, which will be prepared by the anesthesiologist in advance.
~The McGrath or the Macintosh blade will be introduced into oral cavity according to manufacturer recommendations and clinical practice. Minor airway manipulation procedures including BURP or Sellick maneuvers will be allowed to improve visualization of the vocal cords."
15923929|NCT03467035|Other|Inflammasone|Serum level of cytokine and RT-PCR for PBMC
15923930|NCT03467022|Drug|Vitamin C|Patients depleted or deficient in vitamin C by blood test were supplemented orally in vitamin C 1 gram per day for three months
15923931|NCT03467009|Behavioral|iPACT Intervention|Brief in-person + tailored, daily 8-week text-message secondary prevention intervention.
15923932|NCT03467009|Other|Control: Enhanced Usual Care (EUC)|EUC group participants will receive standardized information on cyberbullying.
15923933|NCT03467009|Behavioral|iPACT Intervention- app|Brief in-person + tailored, daily 8-week message secondary prevention intervention delivered via app.
15923936|NCT03466983|Drug|Iron Isomaltoside|administered IV
15923937|NCT03466983|Drug|Ferric Carboxymaltose|administered IV
15923938|NCT03466957|Other|3D printed applicator|add-on cap for oblique needles, 3D printed Vienna-like applicator, individual vaginal cylinder for intracavitary/interstitial application
15923939|NCT03466931|Other|Milk|Meals containing Milk and Milk
15923940|NCT03466918|Device|SAPIEN 3 THV with the Commander delivery system|Edwards SAPIEN 3 Transcatheter Heart Valve is implanted using the Commander delivery system
15923941|NCT03466905|Other|Ambulant assessment|
15923942|NCT03466892|Other|Questionnaires and computer paradigm|Patients will complete different scales and also the visual probe task. First, we hypothesize the attention bias for pain-related information in the FM group is correlated with the level of negative repetitive thinking in the maintained attention phase. Second, we hypothesize the attention bias is more important in the attention maintenance phase (1250 ms) than in the attention orientation phase (500 ms).
15923943|NCT03466879|Device|SYNUS Pain Relief device|SYNUS Pain Relief is a handheld micro-current TENS device used for the temporary relief of sinus pain.
15923944|NCT03466866|Behavioral|COPDE|Community Health Workers (CHWs), who are race-concordant with participants, will: 1) deliver in-home DM education to increase participants' knowledge and skills; 2) use DM-specific Behavioral Activation to improve DM self-care; and 3) facilitate telehealth visits with the participant's primary care physician (PCP) and a DM nurse educator to increase access to care.
15923945|NCT03466866|Behavioral|Intensive Diabetes Education|In-home diabetes education
15923946|NCT03466853|Diagnostic Test|Clinical assessment of nutritional status (CANS) score|Systematized inspection and estimation of loss of SC tissues and muscles of nine superficial physical parameters including hair and buccal fat in the cheeks, chin and neck, arms, back, inter or subscapular skin, buttocks, legs, chest, and abdominal wall skin. These signs will be rated from 1 (worst, severe FM) to 4 (best, well nourished), and the highest and lowest total scores are 36 and 9, 3respectively. A total score of <25 is considered as fetal malnutrition.
15923947|NCT03466853|Diagnostic Test|Anthropometric indices|weight, length and head circumference
15923948|NCT03466853|Diagnostic Test|Proportionality indices|MAC/HC ratio (Calculation for each infant and value will be plotted on and compared with a standard curve). Ponderal index . A PI <2.2 is considered as malnutrition). Body mass index (BMI= weight (kg) / length2 (m). A BMI <11.2 kg/m2 is considered as malnutrition)
15923949|NCT03466840|Procedure|The coronally advanced lingual flap|": A full-thickness crestal incision is performed from the distal surface of the more distal tooth to retromolar pad and finishing with releasing incision. On the lingual side, a full-thickness muco-periosteal flap was elevated until reaching mylohyoid line. Then using a blunt instrument, it was localized a connective tissue band continuing with the epimysium of the mylohyoid muscle. It is inserted into the inner part of the lingual flap about 5mm from the crest in an apical direction. The blunt instrument is inserted below the connective band, and with gentle traction in the coronal direction, this muscular insertion was detached from the lingual flap. Using a periodontal probe, the amount of advancement is measured."
15923950|NCT03466840|Procedure|Modified periosteal releasing Incision|"A full-thickness muco-periosteal flap is reflected on the buccal side. Near the base of muco-periosteal flap, the periosteum is incised less than 0.5mm in depth, creating two segments, coronal segment and apical segment, of the periosteal flap. The flap is pulled with a pair of periodontal forceps laterally. Subsequently, the lateral stretching of the coronal segment of the flap is performed by applying pressure using the blunt face of scalpel blade, or a blunt instrument, with sweeping motion. This motion helps stretching the flap over the submucosa, thereby permitting the flap to be mobile.Using a periodontal probe the amount of advancement is measured."
15923951|NCT03466827|Drug|Selinexor|Selinexor 60 mg oral tablets will be administered twice weekly, either Monday/Wednesday or on Tuesday/Thursday or on Wednesday/Friday in a 3-weeks-on and 1-week-off Schedule.
15923952|NCT03466814|Other|Non-Interventional|Non-Interventional
15923953|NCT03466801|Drug|Prednisone|Prednisone was taken for oral administration with dosage of 1mg/kg/d (maximum 60mg/d) by 8 weeks to start.Then reduced Gradually until the end of the experiment.
15923954|NCT03466801|Drug|MP and CTX|Methylprednisolone(MP) was injected for 3 day(if weight >60kg ,500mg/d<60kg,300mg/d ), methylprednisolone was 0.4mg/kg/d for 27 day.Cyclophosphamide(CTX) orally was 100mg/ d for 1 month.And repeated for six months.
15923955|NCT03466788|Other|Self questionnaires of quality of life and living conditions|Patients will complete self-questionnaires of living conditions and quality of life (QLQ-C30; EN24; CIPN20; IPAQ; HADS)
15923956|NCT03466775|Diagnostic Test|Anti-angiotensin II type 1 receptor antibody measurement|Anti-angiotensin II type 1 receptor antibodies are assessed using quantitative ELISA in stored serum samples obtained within the first year after transplantation
15923957|NCT03466775|Diagnostic Test|Measurement of ENDAT expression level allograft|Endothelial-associated transcript expression level is assessed using microarray in stored kidney allograft biopsies obtained within the first year after transplantation
15923958|NCT03466775|Other|Allograft survival|
15923959|NCT03466775|Other|Allograft rejection appearance|
15923963|NCT03466723|Genetic|biomarker identification in Parkinson disease|circulating miRNAs profiling by NGS analysis functional miRNA characterization association of miRNA levels with genetic variants
15923964|NCT03466710|Procedure|Colposcopy|"Women will undergo colposcopy at 6 and 12 months after randomization. Those with CIN II will be managed according to standard of care. Those with CIN 1 6 months post randomization will have a second exam 6 months later and if still CIN I will have an exit colposcopy 6 months later.
~All women in the Pap and HPV testing policies as well as all women in the colposcopy policy with CIN 1 after 2 exams will have an exit colposcopy 18 months after randomization. The exit colposcopy is a safeguard against the possibility of any false negatives in the follow up policies. The exit colposcopy will also establish the true numbers of CIN lesions in the 3 policies in order to determine their sensitivities and specificities. At the exit colposcopy,all will have an endocervical curettage,and either a minimum of 2 directed biopsies of any mucosal abnormality or in the event no abnormality is identified,2 random biopsies from the cervix."
15923965|NCT03466710|Other|Pap test|"Women will receive Pap tests at 6 and 12 months after randomization. The Pap test will be prepared using the Thinprep® system which is the standard at Calgary Laboratory Services. Women with a Pap test result of malignant, HSIL, AIS, AGC, ASC-H, or LSIL-H (>LSIL) at 6 or 12 months post randomization will be referred for colposcopic examination. Women with an ASC-US or LSIL result (</=LSIL) will have a second follow up Pap test 6 months later (12 months post randomization). Those with a persistent result of ASC-US or LSIL or >LSIL at 6 or 12 months will be referred for colposcopic examination. Outcome in the Pap policy is positive when the histopathology is >/=CIN II. Results of </=CIN I equal a negative outcome.
~All other Pap test results will have an exit colposcopy 6 months later (18 months post randomization)."
15923966|NCT03466710|Diagnostic Test|HPV test|Women will have an HPV test performed on a cervical scrape sample 12 months after randomization. Women with a positive result will be referred for colposcopy. Outcome in the HPV testing policy is positive when histopathology obtained at the colposcopic exam shows CIN II. All other results equal a negative outcome. HPV negative women will have an exit colposcopy 18 months post randomization. HPV testing will be performed using Cervista™HPV HR(Third Wave Technologies Inc./Hologic Inc, Madison, WI, USA).This HPV DNA test identifies 14 high risk types (16,18,31,33,35,39,45,51,52,56,58,59,66,68). Testing will be performed on the residual cervical scrape sample which is fixed in the PreservCyt® solution of the Thinprep® liquid based system(Hologic Inc, Marlborough, Ma, USA). Cervical samples may be held for up to 24 wks at room temperature before DNA extraction.This allows time for transportation without refrigeration.The samples will be sent by overnight express delivery to the laboratory.
15923967|NCT03466697|Other|Glucose injection/Normal saline injection|Before each PET scan, subject will be injected either glucose or normal saline.
15923968|NCT03466684|Other|BIA-guided fluid resuscitation protocol|"In both groups, a multi-frequency BIA with eight tactile electrodes (Inbody S10 Biospace, Biospace Co. Ltd., Seoul, Korea) was used to assess body fluid status every 6h within the first 72h after admission to the ICU and daily for a period of 4 days.
~BIA recording was not adjusted by clinicians in fluid restrict, pharmacological and mechanical means of therapy.
~In contrast, in group BIA, fluid resuscitation protocol with adjustment determined according to HL measured by BIA."
15923969|NCT03466684|Other|Traditional fluid resuscitation protocol|Traditional fluid resuscitation strategy determined by treating clinicians according to usual clinical parameters.
15923970|NCT03466671|Drug|TTA-121|A nove intranasal spray of oxytocin and placebo
15923971|NCT03466658|Device|JumpStart Antimicrobial Wound Dressing|A novel, wireless, low-level microcurrent-generating antimicrobial device (JumpStart) is a sterile single layer dressing consisting of a matrix of alternating silver (Ag) and zinc (Zn) dots that are held in positions on a polyester substrate with biocompatible binder. Dressing is then activated in the presence of a conductive fluid, which may come from wound exudate or exogenous fluids, such as saline. It has been observed, in vitro, to exhibit electricidal effect in the presence of antibiotic and multidrug resistant clinical wound isolates.
15923972|NCT03466645|Drug|Vancomycin|The 1st group receives vancomycin an hour before craniotomy
15923973|NCT03466645|Drug|Cefazolin|The 2nd group receives cefazolin an hour before craniotomy
15923974|NCT03466632|Drug|Propofol|propofol 1.5 mg/kg slow intravenously, followed by maintenance dose of 0.5 mg/kg/h throughout the procedure.
15923975|NCT03466632|Drug|Dexmedetomidine|dexmedetomidine 1 ug/kg over 10 minutes as a bolus dose followed by continuous infusion at a dose of 0.5 ug/kg/h as maintenance dose throughout the procedure
15923976|NCT03466619|Device|inflatable penile prosthesis (IPP)|inflatable penile prosthesis (IPP)
15923977|NCT03466606|Behavioral|pre-habilitation|Personalized supervised resistance training and program to promote physical activity and healthy lifestyles
15923978|NCT03466593|Other|Prehabilitation|Prehabilitation concerning eating, smoking, drinking and physical activity
15923979|NCT03466593|Other|Routine care|Preoperative information
15923980|NCT03466593|Other|Extra early mobilization|Mobilization the day of surgery
15923981|NCT03466593|Other|Standard mobilization|Mobilization the day after surgery
15923982|NCT03466580|Behavioral|The Carer Support Needs Assessment Tool (CSNAT) intervention|The CSNAT intervention is a caregiver-led approach where the caregiver first identifies his/her needs of support in the CSNAT, which consists of 14 support domains. Then the practitioner facilitates the intervention where the caregiver prioritizes which domains to discuss. In the conversation, the caregiver's domain priorities and subsequently identified support needs are discussed with the practitioner to agree on actions/solutions and a shared action plan. The intervention will be offered each caregiver twice: the first time between 0 and 13 days after enrollment, and the second time between 15 and 27 days after enrollment.
15923983|NCT03466567|Drug|Semaglutide|A single dose of 3 mg semaglutide tablet alone will be administered orally. Trial product administration will take place in the morning after overnight fasting for at least 6 hours.
15923984|NCT03466567|Drug|Probenecid|A dose of 500 mg probenecid (2 tablets of 250 mg) will be administered orally twice daily for 3½ days (7 trial product administrations in total). On the 4th day, the last probenecid administration will take place 2 hours prior to administration of a single dose of 3 mg oral semaglutide tablet. The last trial product administrations will take place in the morning after overnight fasting for at least 6 hours.
15924013|NCT03466372|Behavioral|biofeedback|treadmill walking with biofeedback regarding propulsion and other gait parameters
15924297|NCT03464175|Device|Heated-humidified circuit|It will be left on during the transfer and the nebulization in group 1
15923985|NCT03466567|Drug|Ciclosporin|A single dose of 600 mg ciclosporin (6 capsules of 100 mg) will be administered orally 1 hour prior to administration of a single dose of 3 mg oral semaglutide tablet. Trial product administration will take place in the morning after overnight fasting for at least 6 hours.
15923986|NCT03466554|Device|Hyperbaric oxygen-90 minutes exposure to 100% oxygen at 2 ATA, with 5-minute air breaks every 20 minutes|60 daily HBOT sessions will be administrated 5 days per week. comprise of 90 minutes exposure to 100% oxygen at 2 ATA, with 5-minute air breaks every 20 minutes.
15923987|NCT03466541|Behavioral|Riskbruk|The Riskbruk model incorporates alcohol screening through a widely employed alcohol screening questionnaire, the Alcohol Use Disorders Identification Test (AUDIT) and a standard alcohol biomarker, carbohydrate-deficient transferring in serum (CDT), with brief consultations using the motivational interviewing (MI) technique. MI is a collaborative conversation style used to increase awareness and reflection around one's own drinking habits, as well as strengthening the person's motivation for a lifestyle change. The conversation style includes expressing empathy through reflective listening, communicating respect and acceptance of the participants and their feelings, and open up for self-reflection and exploration around the drinking behaviour.
15923988|NCT03466541|Behavioral|Balance|Balance is a new Norwegian eHealth programme, and incorporates two approaches to behaviour modification interventions: a brief interventions and an intensive self-help programme. The intervention is based on cognitive-behavioural and self-help principles, and is given to the participants through multiple interactive sessions.
15923989|NCT03466528|Drug|Magnesium Sulfate|Intravenous (Magnesium Sulphate) MgSO4 2 grams IV over 20 minutes
15923990|NCT03466528|Drug|Pabrinex|standard treatment
15923991|NCT03466515|Procedure|stem cells injection|two surgical interventions as day-surgery, starting with liposuction from the abdomen (about 200-300 ml), and fistula tract debridement and closure of internal opening. The external opening is excised. About 30-40 ml fresh harvested patients own fatty tissue are then injected with large needle around the fistula from internal til external opening.The resting harvested fatty tissue will be sent to stem cells (Adipose Derived Regenrative Cells ADRCs) isolation, using Cytori Celusion system®. When the stem cells isolation is completed, 4ml concentrated stem cells ( contains around 20-40 millions cells ) will be injected around the prepared fistula tract, the same site where the fresh harvested fatty tissue injected before.
15923992|NCT03466502|Drug|Oral Vancomycin|Oral vancomycin will be given concurrently with antibiotics to hospitalized patients with a history of Clostridium difficile infection to prevent recurrence
15923993|NCT03466489|Device|Floraseal|FloraSeal is a cyanoacrylate-based sealant used in the prevention of surgical site infections.
15923994|NCT03466476|Device|Consensus TracPatch|The information gained by the TracPatch wearable technology will be readily available via a HIPAA secure system to the surgeon and patient in order to monitor post-operative recovery and signal to both parties if any intervention is indicated. The device also monitors for rapid acceleration events which may indicate a traumatic injury. Additionally, the temperature sensor may help detect sub-clinical infection.
15923995|NCT03466463|Genetic|GNT0003|Intravenous infusion, single dose
15923996|NCT03466450|Drug|PF-04449913|"Glasdegib (3 dose levels will be evaluated: 100mg QD, 150mg QD and 200mg QD, or 75-50mg) will be administered:
~During concurrent phase concomitantly with radiation and Extended to the resting period (glasdegib will not be stopped in the 4 weeks of radiotherapy resting period).
~During adjuvant therapy with Temozolomide Oral Capsule. Additional treatment with glasdegib beyond 6 sequential TMZ cycles will continue until progression, unacceptable toxicity, non-compliance, consent withdrawal and/or 2 years of glasdegib administration."
15923997|NCT03466450|Drug|Temozolomide Oral Capsule|"During RT, patients will receive Temozolamide (TMZ). All patients will be given TMZ at 75 mg/m2
~/d concurrently with RT for a maximum of 42 days. At 4 weeks after RT completion, patients will start taking TMZ at 150 mg/m2/d for the first 5 days of a 28-day cycle. If first cycle is well tolerated, patients will receive TMZ at 200 mg/m2/d for the first 5 days of every subsequent 28-day cycle for another 5 cycles."
15923998|NCT03466437|Device|Glass-fiber post and composite resin restoration|Patients will receive a glass-fiber and composite resin restoration followed by removable partial denture fabrication
15923999|NCT03466437|Device|Glass-fiber post and metalceramic crown|Patients will receive a glass-fiber and metalceramic crown followed by removable partial denture fabrication
15924000|NCT03466437|Device|Cast-metal post and metalceramic crown|Patients will receive a cast-metal post and metalceramic crown followed by removable partial denture fabrication
15924001|NCT03466424|Radiation|preoperative short-course radiotherapy|Patients will be enrolled into Group 1 to 3 according to the time order of entering the study to receive dose from 6Gy×5F to 8Gy×5F using the traditional 3+3 dose escalation design.
15924002|NCT03466411|Drug|Guselkumab Dose 1|Guselkumab will be administered by IV infusion.
15924003|NCT03466411|Drug|Guselkumab Dose 2|Guselkumab will be administered by SC injection.
15924004|NCT03466411|Drug|Guselkumab Dose 3|Guselkumab will be administered by IV infusion.
15924005|NCT03466411|Drug|Guselkumab Dose 4|Guselkumab will be administered by IV infusion.
15924006|NCT03466411|Drug|Guselkumab Dose 5|Guselkumab will be by SC injection.
15924007|NCT03466411|Drug|Guselkumab|Guselkumab will be administered by IV infusion and SC injection.
15924008|NCT03466411|Drug|Ustekinumab|Ustekinumab will be administered by IV infusion and SC injection.
15924009|NCT03466411|Drug|Placebo|Placebo will be administered as IV infusion.
15924010|NCT03466398|Behavioral|Vivify Health RPM Protocol|The Vivify RPM Protocol includes a wireless tablet and glucometer/Bluetooth device that can directly upload blood glucose readings to the tablet. Patients will daily Care Plan questionnaires on the tablet, as well as upload blood glucose readings twice a day. The tablets will also be used for weekly video conferences with study investigators.
15924011|NCT03466385|Device|Nasal High Flow|Patients admitted to emergency department with COPD exacerbation combined with mild to moderate acute or acute on chronic hypercapnic respiratory failure will be randomized in one of the two study groups. In case of NHF it will be commence immediately with pre-defined settings
15924012|NCT03466385|Device|Non-Invasive Ventilation|Patients admitted to emergency department with COPD exacerbation combined with mild to moderate acute or acute on chronic hypercapnic respiratory failure will be randomized in one of the two study groups. In case of NIV it will be commence immediately with pre-defined settings
15924754|NCT03460886|Other|Walking on treadmill|walking on treadmill for 10 minutes
15924014|NCT03466359|Behavioral|DEF-EI : Energy restriction induced energy deficit|DEF-EI : Energy restriction induced energy deficit The content of their energy intake will be decreased by 10% daily compared with the phase one of the protocol (stabilization of intake). This decrease will be allowed by the internship nature of the clinical program; all the meals are prepared and served by the personal of the clinical centre.
15924015|NCT03466359|Behavioral|DEF-EX : Exercise induced energy deficit|DEF-EX : Exercise induced energy deficit While their intake will remain the same as phase 1, they will increase their physical activity energy expenditure by 10% thanks to an increase of their prescribed exercise intensities or durations.
15924018|NCT03466333|Drug|Enalapril Maleate|Enalapril maleate will be encapsulated; participants will take the drug once a day for 6 months following delivery.
15924019|NCT03466333|Drug|Placebo oral capsule|The placebo will be encapsulated; participants will take the drug once a day for 6 months following delivery. It will be identical in appearance to the IMP.
15924020|NCT03466320|Biological|NKR-2|This Phase I study will explore the hypothesis that the administration of modified T-cells targeting NKG2D-ligands expressed by AML/MDS cells, after a prior nonmyeloablative preconditioning treatment, in patients refractory to and/or relapsing after prior therapies, is safe and, considering the poor outcomes and lack of therapeutic strategies for this patient population, may have a strategic advantage over current approaches and provide potential clinical benefit.
15924021|NCT03466307|Device|Ultrasonography|Ultrasonographic examination of shoulder
15924022|NCT03466294|Drug|Azacitidine and Venetoclax|Azacitidine will be given at dose of 75mg/m2 in Cycle 1 days 1-7; repeat in cycle 2 and 3 if no response. Starting on day 2 of cycle 1, venetoclax will be administered orally with doses increased to a target dose of 600 mg (administer 100 mg on day 2, 200 mg on day 3, 400 mg on day 4 and 600 mg on day 5), then 600 mg daily.
15924023|NCT03466281|Behavioral|Structured patient group education|Patient education in a group setting
15924024|NCT03466281|Behavioral|Education via Internet|Patient education via the internet
15924025|NCT03466268|Drug|Glumetinib for tablet|Either at 100mgSD、100mgQD、200mgSD、200mgQD、400mgSD、400mgQD、300mgBID、400mgBID
15924026|NCT03466255|Other|Ultrasound|Contrast-enhanced ultrasound (CEUS)
15924027|NCT03466242|Drug|Dexmedetomidine|Evaluate sedative and analgesic effects of Intranasal Dexmedetomidine
15924028|NCT03466242|Drug|Ketamine|Evaluate sedative and analgesic effects of Intravenous Ketamine
15924029|NCT03466229|Dietary Supplement|Androferti|
15924030|NCT03466229|Dietary Supplement|Placebo|
15924031|NCT03466216|Drug|AlphaMedix|There is only a single treatment intervention.
15924032|NCT03466203|Biological|LLF580|LLF580 300mg
15924033|NCT03466203|Drug|Placebo|Placebo to LLF580
15924034|NCT03466190|Procedure|Titanium plate fixation|Under General Anesthesia, exposure of the fractured mandibular body segments will be done using a standardized surgical approach. Open Reduction Internal Fixation using conventional titanium plates will be performed.
15924035|NCT03466190|Procedure|Custom made PEEK plate fixation|Under General Anesthesia, exposure of the fractured mandibular body segments will be done using a standardized surgical approach. Open Reduction Internal Fixation using custom made PEEK plates will be performed.
15924036|NCT03466177|Diagnostic Test|Non-invasive, multimodal retinal imaging|Ocular exam including the application of different non-invasive ocular imaging techniques
15924037|NCT03466177|Diagnostic Test|Cerebral imaging|amyloid-PET and MRI
15924038|NCT03466177|Diagnostic Test|Neuropsychiatric testing|neuropsychiatric test battery
15924039|NCT03466177|Diagnostic Test|Venous blood sampling|fasting laboratory tests and apoE genotyping
15924040|NCT03466164|Behavioral|Mindfulness Based Stress Reduction Program|8 week, 10-session course of mindfulness training
15924041|NCT03466151|Device|Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System|Treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements
15924042|NCT03466151|Device|Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System|Treatment of subjects eligible for percutaneous transluminal coronary angioplasty (PTCA) as per study requirements
15924043|NCT03466138|Device|PMD-200|The PMD-200 system is comprised of a console and designated finger probe with 4 sensors. The Sensors are Photoplethysmography (PPG) Galvanic Skin Response (GSR), Accelerometer (ACC) and Thermistor (TMP)
15924044|NCT03466125|Procedure|Cardiac surgery|Retrospective cohort study
15924045|NCT03466112|Other|endurance training|endurance training with stationary bicycles
15924046|NCT03466112|Other|balance and tone program|flexibility, core strength, balance, relaxation
15924047|NCT03466099|Drug|KVD001 Injection|Intravitreal KVD001 Injection
15924048|NCT03466099|Other|Sham Procedure|Sham Procedure
15924049|NCT03466086|Device|Test Eye Drops|blink® intensive TRIPLE ACTION 3 in 1 eye drops
15924050|NCT03466086|Device|Control Eye Drops|Systane® BALANCE eye drops
15924051|NCT03466073|Drug|Recombinant Human Plasma Gelsolin|Recombinant human plasma gelsolin lyophilized for reconstitution, reconstituted in sterile water
15924052|NCT03466073|Other|Normal Saline Placebo|Normal saline in volume equivalent to drug
15924053|NCT03466060|Device|Opti-Free : RevitaLens / Clear Care : RevitaLens|Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
15924054|NCT03466060|Device|Opti-Free : RevitaLens / RevitaLens : Clear Care|Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
15924055|NCT03466060|Device|Clear Care : RevitaLens/ Opti-Free : RevitaLens|Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
15924056|NCT03466060|Device|Clear Care : RevitaLens / RevitaLens : Opti-Free|Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
15924057|NCT03466060|Device|RevitaLens : Clear Care/ Opti-Free : RevitaLens|Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
15924058|NCT03466060|Device|RevitaLens : Clear Care / RevitaLens : Opti-Free|Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
15924059|NCT03466060|Device|RevitaLens : Opti-Free / Clear Care : RevitaLens|Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
15924060|NCT03466060|Device|RevitaLens : Opit-Free / RevitaLens : Clear Care|Subjects between the ages of 18-69 will be randomized to 1 of 3 lenses. Solutions will be administered contralaterally with 1 test solution and 1 of 2 control solutions prior to the subjects' follow-up visits.
15924061|NCT03466047|Dietary Supplement|Protein stomach|encapsulated protein stomach
15924062|NCT03466047|Dietary Supplement|Protein distal small intestine|encapsulated protein distal small intestine
15924063|NCT03466047|Dietary Supplement|CHO stomach|encapsulated CHO stomach
15924064|NCT03466047|Dietary Supplement|CHO distal small intestine|encapsulated CHO distal small intestine
15924065|NCT03466047|Dietary Supplement|Fat stomach|encapsulated Fat stomach
15924066|NCT03466047|Dietary Supplement|Fat distal small intestine|encapsulated Fat distal small intestine
15924067|NCT03466021|Drug|Liraglutide|Initially 0.6 mg daily, increasing weekly with 0.6 mg, until 3.0 mg is reached.
15924068|NCT03466021|Drug|Placebo|Matching injection
15924069|NCT03466008|Behavioral|Whole-Body Cryotherapy|10 sessions of WBC were performed (in addition to usual care) in a standard cryotherapy room over a duration of 8 days.
15924070|NCT03465995|Device|NKI i-PAS Diagnostic Protocol|"The NKI i-PAS:
~The NeuroKinetics i-PAS system is a mobile assessment device with an integrated display for eye tracking with the following properties: a head mounted display, a sampling rate of 100 frames per second, eye tracking in the horizontal, vertical and torsional axes, and pupil area measurement with a spatial resolution less than 0.1 o. The testing protocol includes: optokinetic tracking, smooth pursuit horizontal, smooth pursuit vertical, saccade random horizontal, saccade random vertical, saccade predictive horizontal, antisaccade (horizontal), self-paced saccade, saccade and reaction times, visual reaction time, auditory reaction time, gaze horizontal, light reflex, subjective visual (vertical) and subjective vertical horizontal. Several quantitative measures are computed from the data acquired in each test, and these measures are then employed in a multivariate diagnostic assessment."
15924073|NCT03465969|Drug|tacrolimus|oral
15924074|NCT03465956|Procedure|Laparoscopic Sleeve Gastrectomy|Laparoscopic Sleeve Gastrectomy using the gastro-intestinal anastomosis stapler.
15924075|NCT03465943|Drug|Ringer|1L of Ringer's solution as a preload in one group.
15924076|NCT03465943|Drug|Voluven|500 ml of voluven will be given in combination with 500 ml Ringer's solution as a preload in the other group.
15924077|NCT03465930|Procedure|Supermicrosurgical lymphatico-venous anastomoses|Supermicrosurgical lymphatico-venous anastomoses (sLVA) require an accurate visualization of the lymphatic vessels that are still functional. Lymphatic vessels are visualized with lymphography using a fluorescent dye, indocyanine green. Adjacent superficial veins mapping is obtained with Accuvein device.
15924078|NCT03465917|Combination Product|Renal Denervation|Bilateral denervation of the renal arteries using extravascular administration of neurolytic alcohol
15924079|NCT03465904|Device|Verum Cefaly® Abortive Program device|The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Verum Cefaly® Abortive Program device will deliver verum external trigeminal nerve stimulation.
15924080|NCT03465904|Device|Sham Cefaly® Abortive Program device|The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS). The Sham Cefaly® Abortive Program device will deliver sham external trigeminal nerve stimulation.
15924081|NCT03465891|Drug|atezolizumab|1200mg IV on day 1 of a 21-day cycle for a planned total of 17 cycles of therapy (1 year).
15924082|NCT03465891|Radiation|Low- Dose, Local Radiotherapy|4Gy will be administered in 2 fractions to a single nodal site amenable to radiation as identified by the radiation oncologist on day 2 and day 3 of Cycle 1 (over the two days following to the first dose of atezolizumab ).
15924083|NCT03465878|Drug|LY900014|Administered via SC injection
15924084|NCT03465878|Drug|Insulin Lispro|Administered via SC injection
15924085|NCT03465865|Device|optical coherence tomography|optical coherence tomography enables diagosis of macular structures and therefore provides information on macular hole closure.
15924086|NCT03465852|Behavioral|ChiCAS|Promotes access to and participation by HIV negative Hispanic/Latina transgender women who have sex with men in PrEP, medically supervised hormone therapy, and consistent condom use.
15924087|NCT03465839|Behavioral|Education for improving handovers quality|Specific education on the importance of handovers quality will be provided. The educational session will last 4 hours. The program will be divided into the following sections: 1) a structured survey on the perception of the participants on the handovers importance; 2) Key theoretical concepts on the relevance of handovers with case studies of errors related to this critical moment; 3) showing movie clips of nursing handovers to critically interpret the clips by the participants; 4) presentation of the SBAR method recommended by WHO; 5) general presentation of the nursing delivery assessment project of the Valduce Hospital.
15924088|NCT03465839|Behavioral|Education for improving bedside handovers|In addition to the education for improving handovers quality, the following intervention will be implemented for nurses assigned to the study department. The course will be supplemented by a section of the duration of an hour, containing 1) information on the principles underlying bedside handovers; 2) how to handle information in front of the patient and on his / her direct involvement; 3) role-playing of the bedside handover will be performed, assigning the roles of nurse and patient among the participants to bring out impressions linked to the functions.
15924089|NCT03465826|Behavioral|PainCOACH Pain Coping Skills Training|Migraineurs will participate in 4 weeks of daily headache monitoring, baseline questionnaires, followed by 8 weeks of the PainCOACH migraine mHealth Pain Coping Skills Training program (developed by Drs. Keefe and Rini based on social cognitive theory and in-person pain coping therapy sessions). Following the 8 week mHealth intervention, participants will immediately complete post-treatment assessments and later will complete follow-up assessments at 3 and 6 months.
15924090|NCT03465826|Behavioral|Treatment as Usual|Participants will keep headache diaries for 4 weeks, followed by baseline assessments + 8 weeks of daily headache monitoring (as a parallel to the PainCOACH intervention). Post-assessments will immediately follow, and participants later will complete follow-up assessments at 3 and 6 months.
15924091|NCT03465813|Behavioral|CaringGuidance After Breast Cancer Diagnosis|CaringGuidance After Breast Cancer Diagnosis, psychoeducational, Internet-accessible program
15924092|NCT03465800|Behavioral|self-monitoring|self-monitoring of physical activity
15924093|NCT03465800|Behavioral|daily incentives|daily incentive payments for physical activity
15924094|NCT03465800|Behavioral|delayed lump sum incentives|delayed lump sum payments for physical activity
15924095|NCT03465787|Drug|Lurasidone HCL 160 mg|Lurasidone HCL 2 80mg tablets, QD
15924096|NCT03465787|Drug|Quetiapine XR 600 mg|Quetiapine XR 2 300 mg tablets, QD
15924097|NCT03465774|Drug|Doxycycline|Receive via IPC
15924098|NCT03465774|Device|Indwelling Catheter|Receive IPC
15924099|NCT03465774|Procedure|Quality-of-Life Assessment|Ancillary studies
15924100|NCT03465774|Other|Questionnaire Administration|Ancillary studies
15924101|NCT03465774|Other|Survey Administration|Ancillary studies
15924102|NCT03465761|Device|ExAblate|Bilateral side treatment of Essential Tremor
15924103|NCT03465748|Device|OrthoK|orthok (orthokeratology) is the science of changing the curvature or shape of the cornea to change how light is focused on the retina at the back of one's eye. Specially designed molding retainer contact lenses are placed on the eye at night and are removed upon awakening.
15924104|NCT03465735|Combination Product|Vascular Boot|The Vascular Boot is one size fits all, insulated fleece padding, and cell foam to enhance and maintain lower limb warmth while maintaining no pressure points on the lower extremity.
15924105|NCT03465735|Drug|Standard of Care|Anticoagulant therapy will be decided by physician and patient.
15924108|NCT03465709|Drug|Pegcetacoplan|Study Drug
15924109|NCT03465696|Behavioral|Group #2 (Intervention)|"Group #2 (Intervention)
~Survey 2 will be administered, and patients will be asked the following primer:
~Stelara® inhibits interleukin 23, one of the immune signaling molecules involved in psoriasis. People who are born with a genetic deficiency in the immune signal interleukin-23 are generally healthy, but also have a LOWER risk of getting immune diseases like psoriasis.
~How willing would you be to take Stelara® to treat your psoriasis, on a scale of (1 = definitely willing, 2 = probably willing, 3 = probably not willing, 4 = definitely not willing)"
15924110|NCT03465696|Behavioral|Group #3 (Intervention)|"Group #3 (Intervention)
~Survey 3 will be administered, and patients will be asked the following primer:
~Stelara® inhibits interleukin 23, one of the immune signaling molecules involved in psoriasis. People who are born with a genetic deficiency in the immune signal interleukin-23 are generally healthy, but also have a LOWER risk of getting immune diseases like psoriasis.
~What do you think would be the best way to describe this to a patient?
~Stelara® acts in an almost all-natural way to help control psoriasis.
~Stelara® blocks one of the genetic causes of psoriasis.
~Stelara® makes psoriasis better by blocking the overactive signal that gets the immune system out of balance
~Stelara® blocks interleukin-23, an important immune system signaling molecule involved in psoriasis
~How willing would you be to take Stelara® to treat your psoriasis, on a scale of (1 = definitely willing, 2 = probably willing, 3 = probably not willing, 4 = definitely not willing)"
15924111|NCT03465683|Other|ESBL-producing Enterobacteriaceae|Data and biological sample collection
15924112|NCT03465670|Device|CHX|Patients received a 21-day supply of 0.2% chlorhexidine (CHX) according to the randomization list, and were instructed to use 10 ml of the assigned mouthrinse for 1 minute, t.i.d. for 21 days. After rinsing, patients were asked to avoid washing their mouth or drinking for 30 minutes. Patients were asked to return the mouthrinse bottles (either empty of filled) at the end of the experimental period (day 21), in order to assess the level of patient compliance with the assigned CHX regimen.
15924113|NCT03465670|Device|CHX+HA+ADS|Patients received a 21-day supply of 0.2% chlorhexidine (CHX) containing 0.2% hyaluronic acid (HA) and Anti-Discoloration System (ADS) according to the randomization list, and were instructed to use 10 ml of the assigned mouthrinse for 1 minute, t.i.d. for 21 days. After rinsing, patients were asked to avoid washing their mouth or drinking for 30 minutes. Patients were asked to return the mouthrinse bottles (either empty of filled) at the end of the experimental period (day 21), in order to assess the level of patient compliance with the assigned CHX regimen.
15924114|NCT03465644|Drug|Tailored antithrombotic strategy|Low-dose (60mg) ticagrelor + aspirin for 6months and then clopidogrel alone for 6months
15924115|NCT03465644|Drug|Conventional antithrombotic strategy|Clopidogrel + aspirin for 12months
15924116|NCT03465631|Device|SMART Glove system with tDCS|combined bilateral tDCS and VR-based therapy on distal upper extremity training in patients with stroke.
15924117|NCT03465631|Device|SMART Glove system with sham-tDCS|combined bilateral tDCS and VR-based therapy on distal upper extremity training in patients with stroke.
15924155|NCT03465293|Other|Bacterial composition and activity after bowel preparation|Bacterial composition and activity and patient's symptoms will be assessed pre and post bowel preparation taken as part of the preparation to have a pre-planned colonoscopy
15924118|NCT03465618|Drug|89Zr-DFO-cRGDY-PEG-Cy5-C' dots PET Imaging|A low dose spiral CT is performed first per the standard procedure. These images will be used for both attenuation correction and registration of the serial image set. The initial PET brain scan will be acquired up to about 24 hours post injection. Based upon the discretion of the physician, non-surgical patients have the possibility of a second scan and third up to about 48 hours post injection. The times per bed position may be adjusted after the first patient is imaged, and his/her scans evaluated. Additional low dose CT scans will be performed at the image session for attenuation correction and image registration. PET study may be done on a PET-MR scanner for ease.
15924119|NCT03465618|Other|Blood and Urine samples|Venous blood and urine samples will be obtained at approximately 0.5 hours post injection at the end of each scan
15924120|NCT03465605|Diagnostic Test|frailty test|questionnaire
15924121|NCT03465592|Drug|Nivolumab|Administered IV
15924122|NCT03465579|Diagnostic Test|pelvic MRI|multi-parametric pelvic MRI
15924123|NCT03465579|Diagnostic Test|68Ga-PSMA PET/CT|68Ga-PSMA PET/CT
15924124|NCT03465566|Diagnostic Test|IDS;MMSPE;CDI 2;CBCL;tests of facial expression evaluation|Five pictures (including nonfacial features; i.e., hairs) were used for each emotion, giving a total of 25 trials.Stimuli consist of pictures of facial affect taken from the Ekman and Friesen series.
15924125|NCT03465553|Radiation|Short course radiotherapy|An accelerated hypo-fractionation radiotherapy is delivered for palliation in patients with advanced thoracic cancer
15924126|NCT03465540|Drug|AMG 397|AMG 397 will be administered orally once or twice weekly as part of a 28-day treatment cycle.
15924127|NCT03465540|Drug|Dexamethasone|Dexamethasone will be administered intravenously (IV) or orally on Days 1, 8, 15, and 22 of each 28-day cycle.
15924128|NCT03465540|Drug|Azacitidine|Azacitidine will be administered intravenously (IV) or subcutaneously (SC) daily for the first 7 days of a 28-day cycle.
15924129|NCT03465527|Drug|PrednisoLONE 50 MG|Prednisolone 50mg bid po or iv (equivalent dose of other steroid) for 5 days ± 2 days
15924130|NCT03465501|Radiation|Brachytherapy|Brachytherapy
15924131|NCT03465488|Drug|Albendazole Pill 400mg (GSK)|One single dose of 400mg Albendazole is provided at baseline.
15924132|NCT03465462|Dietary Supplement|group/arm C (control group)|Group C in the third stage (30 days) continued drug use with no change in diet and no mineral supplementation.
15924133|NCT03465462|Dietary Supplement|group/arm D (diet group)|Group D in the third stage (30 days) received an optimal-mineral-content properly balanced diet enriched in food with high zinc content.
15924134|NCT03465462|Dietary Supplement|group/arm S (supplementation group)|Group S in the third stage (30 days) received zinc supplementation as one capsule containing 15 mg of Zn taken orally once a day in the morning, two hours after antihypertensive drug administration with no change in diet.
15924135|NCT03465449|Behavioral|CKD-EDU|Palliative Care based coaching intervention for support with dialysis-related decision making.
15924136|NCT03465449|Other|usual care|Nephrologist based usual care
15924137|NCT03465436|Drug|Lasmiditan|100 mg administered orally (PO)
15924138|NCT03465436|Drug|Lasmiditan|400 mg administered PO
15924139|NCT03465436|Drug|Placebo|Placebo administered for lasmiditan or moxifloxacin
15924140|NCT03465436|Drug|Moxifloxacin|400 mg moxifloxacin administered PO
15924141|NCT03465423|Procedure|Not applicable (measuring subject's effect site concentration of propofol during the induction of general anesthesia)|The patients of two cohort group will undergo general anesthesia in the same way and therefore there is no intervention in this study.
15924142|NCT03465410|Drug|Standard dosage of Tacrolimus|Immediate release Tacrolimus (Prograf/Adoport)
15924143|NCT03465410|Drug|Bayesian Prediction Tacrolimus dosage|Immediate release Tacrolimus (Prograf/Adoport)
15924144|NCT03465397|Diagnostic Test|biomarkers driven immunosuppressive therapy|the immunosuppressive treatment of the patients is determined according to the result of 2 biomarkers of immunological risk
15924145|NCT03465384|Behavioral|Comet|The intervention is a behaviorally based and manualized parent training program.
15924146|NCT03465371|Other|CSC OnDemand Training Intervention|"Level 1: Readiness
~Online readiness tool
~Level 2: Core Knowledge
~Week 1-self-paced core curriculum, totaling 8 hours of instruction
~Level 3: Going Deeper
~Week 2-instructor-led, role-specific, and advanced topics, totaling 12 hours of instruction
~Level 4: Sustainability
~9 months of online community of practice support; a discussion forum; open office hours with experts; multisite case conferencing; access to online materials"
15924147|NCT03465371|Other|InPerson Intervention|"Level 1: Readiness
~Telephone conversations with program leaders to determine structures, roles, staffing, recruitment
~Level 2: Core Knowledge
~1 day of in-person training on FEP basics and CSC components
~Level 3: Going Deeper
~1.5 days of in-person training on how the team works, followed by breakout sessions by role
~Level 4: Sustainability
~9 months of monthly implementation coaching calls with team leads; monthly telephone case conferences; monthly care coordination calls split out by role"
15924148|NCT03465358|Other|Items completion|"Patients will complete his Motor Function Measure in the usual way, except items 18, 19 and 22 which will be completed twice: once using conventional material and once on a digital tablet.
~The order of completion between conventional material or digital tablet will be allocate randomly."
15924149|NCT03465345|Drug|Metformin|Metformin: The starting dose for Metformin is 850mg once a day, the second dose is 850mg once a day; the third dose level is 850mg twice a day; the fourth dose level is 850mg twice a day. Each dose level lasts for 28 days.
15924150|NCT03465345|Drug|Oligomeric Procyanidin Complex|OPC: The starting dose for OPC is 500mg once a day; the second dose is 1000mg once a day; the third dose level is 1000mg once a day; the fourth dose level is 1500mg once a day. Each dose level lasts for 28 days.
15924151|NCT03465332|Other|Doctor's questionnaire|The survey of physicians will be performed using doctor's questionnaire, which will be developed by lung specialists who are not participating in the survey.
15924152|NCT03465332|Other|Subject file|All subject-based data will be obtained by retrospective evaluation of subject files available at the treating lung specialist.
15924153|NCT03465306|Behavioral|Cognitive Behavioral Therapy|Cognitive-behavioral therapy is a psycho-social intervention that is the most widely used evidence-based practice for improving mental health and requires active interactions between the participants and a therapist or coach.
15924154|NCT03465306|Device|Self-guided|Self-guided refers to any contact between the participants and a therapist or coach.
15924166|NCT03465267|Device|Armeo power|"Intervention with Armeo power rehabilitation robot for upper extremity (made by Hocoma), which provide assistive force.
~The intervention was done 4 weeks, 5 times/week, 30 minutes/day."
15924167|NCT03465267|Device|Armeo spring|"Intervention with Armeo spring rehabilitation robot for upper extremity (made by Hocoma), which is operated only by participants, without any assistive force from robot.
~The intervention was done 4 weeks, 5 times/week, 30 minutes/day."
15924168|NCT03465241|Diagnostic Test|the ctDNA dynamic monitoring|To detect ctDNA in patients using the second generation of high-throughput gene sequencing (NGS)
15924169|NCT03465228|Device|Training and LED group|The LED application will be performed before GTL training sessions and will be applied through the spot method with direct contact of the equipment over the irradiated site for 30 seconds. The application will be in four points in the lumbar region, above the gluteal region, with an angle of 90 ° in relation to the cutaneous surface. A wavelength of 660 to 850nm will be used with a frequency of 0 to 1500 Hz and energy irradiated of 0.9 J of each diode totaling 43.2J (48 diodes).
15924170|NCT03465228|Device|Training group|The training sessions will be monitored based on the subjective perception of exertion of the session (PSESession) (FOSTER, 1998), and heart rate. There will be two types of training: continuous and interval training. The sessions of the training group (GT) and group training + LED (GL) will be preceded by a warm-up of 15 minutes. Participants in the two training groups will undergo weekly training twice weekly on non-consecutive days during four weeks. Continuous training will be 30 minutes at 70% to 80% of maximum heart rate, and interval training will be performed 30 minutes at 100% maximum heart rate of laced racing with fixation of an elastic tube in the floating vest, 30 seconds of intense running and 30 seconds interval. The LED off will be performed before training sessions.
15924171|NCT03465228|Other|LED group|This group will be applied through the spot method with direct contact of the equipment over the irradiated site for 30 seconds. The application will be in four points in the lumbar region, above the gluteal region, with an angle of 90 ° in relation to the cutaneous surface. A wavelength of 660 to 850nm will be used with a frequency of 0 to 1500 Hz and energy irradiated of 0.9 J of each diode totaling 43.2J (48 diodes).
15924172|NCT03465215|Device|Digital holographic microscopy|Tissue obtained from CD patients will be analyzed using digital holographic microscopy. Results will be compared between non-stenotic and stenotic tissue of the intestinal wall of CD patients.
15924173|NCT03465202|Drug|Capecitabine|
15924174|NCT03465189|Device|Medtronic LINQ Device|Using two LINQ devices that are fixed to scalp to record EEG (in addition to the standard scalp EEG).
15924175|NCT03465176|Other|Aromatherapy Blend|The essential oil intervention is a blend of plant derived oils which have been distilled from crude plant matter and analyzed in a laboratory to identify chemical composition.
15924176|NCT03465176|Other|Placebo|The placebo substance is an odorless vegetable oil derived from avocados.
15924177|NCT03465163|Device|Deep Brain Stimulation|The device is called the Medtronic Activa PC+S system. Two devices will be implanted per participant. The electrodes will be surgically implanted bilaterally into the hippocampus and anterior nucleus of the thalamus.
15924178|NCT03465150|Other|acne|Patient with acne
15924179|NCT03465137|Behavioral|Coordinated Anxiety Learning and Management (CALM)|Exposure-focused cognitive behavioral therapy
15924180|NCT03465124|Device|Femtosecond Laser|Femtosecond Laser assisted Cataract Surgery will be performed unilateral in randomized order. Contralateral eye will receive conventional cataract surgery
15924181|NCT03465124|Other|Manual Cataract Surgery|conventional cataract surgery as control
15924182|NCT03465111|Drug|ACTH (adrenocorticotropic hormone) gel|The dose of H.P. Acthar Gel is 80 Units administered subcutaneously
15924183|NCT03465098|Other|Strict low carbohydrate diet (< 3gr/day of carbohydrate) before a 18F-FDG PET/CT|The patients will receive 2 PET/CT , first exam with standard diet preceded by 12h fasting and second exam preceded by 3 meals strict low diet and 12h fasting
15924184|NCT03465085|Drug|Unfractionated heparin|Heparin or Streptokinase were nebulized by Aeroneb Pro@ Lab mesh nebulizer (Aerogen Limited, Galway, Ireland) which is incorporated within GE Healthcare's Engström Carestation ventilator (General Electric Company, Finland). Aeroneb nebulizer is a palladium vibrating mesh nebulizer. The central aperture plate of the nebulizer is 5mm in diameter and is perforated with 1000 precision formed holes, that vibrate at 128,000 times per second, to produce the particles with size 1-5 micron in diameter with average MMAD (Mean Mass Aerodynamic Diameter) is 2.1 microns. The nebulized medication (either streptokinase 250,000 IU or heparin 10.000 IU) was prepared in 3 ml volume of distilled water and nebulized for a period of 15 minutes every 4 hours.
15924185|NCT03465085|Drug|Streptokinase|Heparin or Streptokinase were nebulized by Aeroneb Pro@ Lab mesh nebulizer (Aerogen Limited, Galway, Ireland) which is incorporated within GE Healthcare's Engström Carestation ventilator (General Electric Company, Finland). Aeroneb nebulizer is a palladium vibrating mesh nebulizer. The central aperture plate of the nebulizer is 5mm in diameter and is perforated with 1000 precision formed holes, that vibrate at 128,000 times per second, to produce the particles with size 1-5 micron in diameter with average MMAD (Mean Mass Aerodynamic Diameter) is 2.1 microns. The nebulized medication (either streptokinase 250,000 IU or heparin 10.000 IU) was prepared in 3 ml volume of distilled water and nebulized for a period of 15 minutes every 4 hours.
15924186|NCT03465072|Other|Exercise training|8 weeks, 3 times per week, 30-40 minutes
15924187|NCT03465059|Drug|Zanubrutinib|A single oral dose of 80 mg Zanubrutinib will be administered.
15924188|NCT03465046|Combination Product|intensive therapies(CIMT/BIT): protocol 1 or protocol 2|"The therapies applied in both protocols are intensive therapies that allow the execution of unimanual activities or bimanual activities with the affected upper limb with different doses.
~the protocols were carried out at home through the family"
15924189|NCT03465033|Other|Early Physiotherapy|"From T1 to T2 patients will perform 3 daily repetitions of active exercises:1 5 repetitions of oral opening exercises and bilateral manual progressive stretching, protrusion and maximum lateralization of the jaw on both sides, holding each movement for 5s and a session of cryotherapy applied to the masseter, temporal and suprahyoid muscles for 120s in two 60s sessions. They will also perform 30 repetitions of exercises aimed at improving the labial seal (inflate cheeks) and the symmetry of the upper lip (broad smile). From T2 to T3 30 repetitions of the same exercises will be performed and passive progressive opening will be implemented by clamping Patients will also perform isometric contraction exercises in opening, closing, laterotrusion, protrusion and retrusion. Each movement will be repeated 5 times and it will remain for 5s."
15924191|NCT03465007|Drug|Hydrocortisone|we will give IV Hydrocortisone 100 mg prior to HD to the patients who developed intra-dialytic hypotension and monitor their BP response during the HD treatments.
15924192|NCT03465007|Drug|Normal saline|we will give IV normal saline 100 mg prior to HD to the patients who developed intra-dialytic hypotension and monitor their BP response during the HD
15924193|NCT03464994|Diagnostic Test|ophthalmological examination|"Refraction
~Best corrected visual acuity
~Intraocular pressure
~Slit lamp examination with vital dye (Oxford grading)
~Tear break-up time (TBUT)
~Schirmer I testing
~Specular (TMS-4 Tomey) and elevation (pentacam Oculus and Orbscan Bausch & Lomb) corneal videotopographies
~Pachymetry
~Questionnaires: Ocular surface disease index, quality of vision (visual analogic scale), and quality of life (NEI-VFQ25)
~questionnaire about ichthyosis severity
~questionnaire about life quality specifically for patient presenting ichthyosis"
15924194|NCT03464968|Drug|Oxaliplatin,5FU, leucovorin|mFOLFOX
15924195|NCT03464968|Drug|irinotecan,5FU, leucovorin|mFOLFIRI
15924196|NCT03464955|Behavioral|Technology Based Distractions|Technology based distractions (VR headsets, AR headset, tablets, or BERT projector)
15924197|NCT03464942|Radiation|SABR|Single Dose Group: this group will receive 20 Gy of radiation in a single dose within 10 days of randomisation Fractionated Dose: Participants in this dose will receive a total of 24Gy of radiation given as 3 separate fractions of 8 Gy each.
15924198|NCT03464942|Drug|Atezolizumab|All participants will commence atezolizumab (within 5 days of last SABR dose) 1200 mg every 3 weeks for 24 months
15924199|NCT03464929|Device|Airtraq indirect laryngoscopy|Attempt to intubation using the Airtraq device
15924200|NCT03464929|Device|King Vision indirect laryngoscopy|Attempt to intubation using the King Vision device
15924201|NCT03464916|Biological|CAR2 Anti-CD38 A2 CAR-T Cells|Autologous IV infusion; dose-escalation
15924202|NCT03464890|Other|P926 - LICHTENA DermAD CREMA VISO|The study product was applied on a skin areas of about 14 cm2 of the forearm, defined turning on the right and left side in accordance with a randomization list, on which an erythema has been experimentally induced by repeated tape stripping.
15924203|NCT03464890|Other|P927 - LICHTENA DermAD CREMA CORPO|The study product was applied on a skin areas of about 14 cm2 of the forearm, defined turning on the right and left side in accordance with a randomization list, on which an erythema has been experimentally induced by repeated tape stripping.
15924204|NCT03464890|Other|P926 - LICHTENA DermAD CREMA VISO - PLACEBO|The study product was applied on a skin areas of about 14 cm2 of the forearm, defined turning on the right and left side in accordance with a randomization list, on which an erythema has been experimentally induced by repeated tape stripping.
15924205|NCT03464890|Other|Untreated control area|Untreated skin area of about 14 cm2 of the forearm, defined turning on the right and left side in accordance with a randomization list, on which an erythema has been experimentally induced by repeated tape stripping.
15924206|NCT03464877|Other|Multi-station full-body supervised exercise program|The exercise program was 6-week duration, 2-3 visits per week. It was composed of 7 stations, each consisting of numerous exercises of increasing difficulty. The exercises were grouped together as follows: Hip strengthening and control (Station 1); The squat and its variants (Station 2); Elastic bands and the Bodyblade (Station 3); Abdominal planks and their variants (Station 4); Abdominal strengthening (Station 5); Back extensor strengthening (Station 6); and Lifting techniques (Station 7).
15924207|NCT03464864|Drug|Treprostinil Inhalation Powder|Single ascending dose
15924208|NCT03464851|Diagnostic Test|Carotid Stenotic Scan (CSS)|"Placement of the CSS instrument on the carotid arteries to measure degree of stenosis
~of the carotid artery. The CSS scan takes about 1-2 minutes to gather data for real-time analysis by the processor on the device cart."
15924209|NCT03464838|Device|Transcranial direct current stimulation (tDCS)|Transcranial direct current stimulation (tDCS) is a form of noninvasive brain stimulation that applies a very low electrical current to the scalp. tDCS will be applied with intensity of 1.8 milliamps in real stimulation condition and 0 milliamps in sham condition, during 20 minutes, using a high density (HD) tDCS montage over the Prefrontal Cortex (PFC). Electroencephalography (EEG) resting state activity will be measured before and after tDCS.
15924210|NCT03464838|Behavioral|Cognitive Behavioural Therapy (CBT)|Cognitive Behavioural Therapy (CBT) is the current treatment available for disordered gamblers at the UK National Problem Gambling Clinic. During the therapy sessions patients acquire learning strategies, cognitive and motivational elements, and develop personal skills to help them improve the understanding of their problems.
15924211|NCT03464825|Other|Specific and progressive balance training|Specific and progressive balance training for the intervention group
15924212|NCT03464812|Behavioral|DSMES|It is primarily an educational intervention that is focused on assisting patients improve their management and coping with type 2 diabetes.
15924213|NCT03464799|Other|immunohistochemical staining|immunohistochemical staining
15924214|NCT03464786|Device|Lando® absorbable collagen membrane|Subjects who are fit for the study will be randomized to either intervention arms.
15924215|NCT03464786|Device|Geistlich Bio-Gide resorbable bilayer membrane|Subjects who are fit for the study will be randomized to either intervention arms.
15924216|NCT03464773|Other|PIUO Pathway|See arm descriptions
15924217|NCT03464760|Dietary Supplement|3.5g of spirulina per day in 1% silicone|5 tablets of 700mg per day
15924218|NCT03464760|Dietary Supplement|placebo|5 tablets per day of potato-based placebo
15924219|NCT03464747|Device|EIRUS system (Maquet Critical Care AB, 17154, Solna, Sweden)|continuous measurement of venous lactate through a central venous catheter by microdialysis
15924220|NCT03464734|Drug|Pembrolizumab and Nanoparticle Albumin-bound Paclitaxel|At study entry, patients will receive 2 cycles of pembrolizumab at the dose of 200 mg, intravenously in 30 min, on day 1 and nab-paclitaxel 125 mg/m2 intravenously in 30-40 min, on day 1 and 8.
15924221|NCT03464721|Device|issued with SMART ANGEL device|patients will use the technology at home to record and transmit data for blood pressure and oxygen saturation
15924222|NCT03464708|Dietary Supplement|HMB|Powder form
15924223|NCT03464708|Other|Lactose (placebo)|Powder form
15924224|NCT03464695|Device|O2matic|Continous measurement of SpO2 during an admission with COPD, and closed-loop control of oxygen-delivery to maintain SpO2 within a target interval.
15924225|NCT03464682|Drug|HS-25 10mg|HS-25 10mg 1tablet add placebo of HS-25 1 tablet, placebo of Atorvastatin 1 tablet
15924226|NCT03464682|Drug|HS-25 10mg combination with Atorvastatin|HS-25 10mg 1 tablet , Atorvastatin 10mg 1 tablet, Placebo of HS-25 1 tablet
15924227|NCT03464682|Drug|HS-25 20mg combination with Atorvastatin|HS-25 10mg 2 tablets, Atorvastatin 10mg 1 tablet
15924228|NCT03464682|Drug|Atorvastatin 10mg|Atorvastatin 10mg 1 tablet, placebo of HS-25 2 tablets
15924229|NCT03464682|Drug|HS-25 20mg|HS-25 10mg 2 tablets, placebo of Atorvastatin 1 tablet
15924230|NCT03464682|Drug|Placebe of HS-25 and Atorvastatin|Placebe of HS-25 2 tablets, Placebo of Atorvastatin 1 tablets
15924231|NCT03464669|Other|Prenatal education|Observational study : natural distribution of participants between groups
15924232|NCT03464656|Drug|Fairhaven Pro for men|"Fairhaven Pro for men
~The antioxidant formula (Fairhaven Health) contains:
~B12 (1000 mcg)
~Zinc (30 mg)
~Selenium (140 mcg)
~Arginine (350 mg)
~L-carnitine tartrate (2000 mg) , providing 1,340 mg of L-carnitine
~CoQ10 (200 mg)
~Vitamin C (120 mg) and Vitamin E (200 IU)"
15924233|NCT03464656|Diagnostic Test|Semen analysis|"Full semen analysis according to WHO semen laboratory manual 5th edition will be done pre and 3 months post-treatment.
~After complete liquefaction, each sample was evaluated for both macroscopic parameters such as color, pH, ejaculate volume, age of the sample and viscosity. An aliquot of the sample was examined for sperm concentration, total sperm count, total and progressive motility and sperm morphology using the WHO fifth edition guidelines (WHO, 2010). Semen analysis was done manually using a hemocytometer. Sperm motility was assessed and categorized as progressive or non-progressive. Morphology was assessed by a single experienced technician using the Diff-Quik staining protocol. Kruger's strict criteria were used for morphology assessment with 4% normal morphology as a cut-off (WHO, 2010)."
15924234|NCT03464656|Diagnostic Test|Sperm DNA fragmentation|Sperm DNA fragmentation was evaluated using the Halosperm kit from Halotech DNA, S.L. (Madrid, Spain) as per manufacturer instructions. The method is based on the sperm chromatin dispersion test (Fernández et al., 2003). A minimum of 500 spermatozoa were scored and reported as percentage of sperm with spermatozoa with fragmented DNA. Normal value is measure at a cut-off value of more than 30%
15924235|NCT03464656|Diagnostic Test|Static Oxidation reduction potential in semen|Oxidative stress was assessed by measuring the static oxidation-reduction potential (sORP) of neat liquefied semen samples using the MiOXSYSTM System (Aytu Bioscience, Inc., Englewood, USA). This is a galvanostatic measure of the electron transfer from reductants (antioxidants) to oxidants under a steady low voltage reducing current. Thus, providing an aggregate measure of all current oxidant activity and antioxidant activity in a sample. Higher sORP values (millivolts, mV) indicate a higher oxidant activity relative to the antioxidant activity and therefore greater state of oxidative stress.
15924236|NCT03464643|Other|embryo culture|Single embryo culture means only one embryo is cultured in one drop, and the group culture refers to culture of 2-5 embryos in one drop. The main advantage of group culture may be secreting some paracrine cytokines by embryos and benefit each other; and the possible disadvantage of group culture is that embryo secreting of some harmful substances which accumulated to a certain extent will damage the developmental potential of embryos. The advantages and disadvantages of single embryo culture are contrary to group culture.
15924237|NCT03464630|Behavioral|Mom & Baby Net|Skills based maternal depression treatment and targeted infant social-communication promotion
15924238|NCT03464630|Behavioral|Developmental Awareness System|Depression and infant develop awareness
15924239|NCT03464604|Diagnostic Test|active|Pre-screening for melanoma by qualified nurse
15924240|NCT03464578|Procedure|Therapy of proximal humeral fractures (irrespective conservative or operative)|
15924241|NCT03464565|Device|Penumbra System|Penumbra System
15924242|NCT03464552|Drug|Celecoxib 200mg|oral capsule 3 hours before procedure
15924243|NCT03464552|Procedure|Colposcopic guided biopsy|Patient is placed in the lithotomy position. Vulva is examined for any suspicious lesions. A sterile bivalve speculum is introduced into the vagina to inspect cervix. A 3% acetic acid solution is applied to the cervix to map acetowhite areas for colposcopic directed punch biopsy using Tischler punch forceps.
15924244|NCT03464552|Drug|Placebo oral capsule|oral capsule 3 hours before procedure
15924245|NCT03464539|Dietary Supplement|PG low molecular weight chitosan|The product 1000 mg of Polyglucosamine was administered three times per day before and in between main meals
15924246|NCT03464526|Drug|Orvepitant|Tablet, once daily, oral
15924247|NCT03464526|Drug|Placebo|Tablet, once daily, oral
15924248|NCT03464513|Device|Multislice CT Angiography|Multislice CT angiography (MSCTA) provides a relatively non-invasive and effective way of localising the source of bleeding, especially in patients with continuous bleeding.
15924249|NCT03464500|Dietary Supplement|AMAZ-02 Low dose|AMAZ-02 containing softgels
15924250|NCT03464500|Dietary Supplement|AMAZ-02 High Dose|AMAZ-02 containing softgels
15924251|NCT03464500|Dietary Supplement|Placebo|Placebo containing softgels
15924252|NCT03464487|Dietary Supplement|Low Glycemic Index Therapy Diet|Low Glycemic Index Therapy Diet allows only carbohydrates with Glycemic Index less than 50 and also restricts daily carbohydrate intake to less than 40-60 gram per day.
15924253|NCT03464474|Device|digital holographic microscopy|Colonic biopsies from all patients will be assessed using digital holographic microscopy in comparison to the existing Goldstandard (histopathological analysis).
15924254|NCT03464461|Drug|Ketorolac|IV drug
15924255|NCT03464448|Drug|Teriflunomide|AUBAGIO® (teriflunomide) is a prescription medicine used to treat relapsing forms of multiple sclerosis (MS), which inhibits pyrimidine de novo synthesis by blocking the enzyme dihydroorotate dehydrogenase.
15924256|NCT03464435|Drug|Tacrolimus|All the patients will be treated with 0.1% tacrolimus suspension two times daily, LE/T eye drops four times daily for 1 month. 0.1% tacrolimus will be continued for the last 5 months.
15924257|NCT03464422|Behavioral|ESTEEM conneCT|"The intervention adapts the ESTEEM (Pachankis et al, 2015) intervention to address the multiple-stigma stressors faced by MSM of color, including sexual orientation and racial stigma in a manualized, CBT-based intervention. Approximately thirty participants (divided between two cohorts) will complete ten group sessions will take place at regular times once per week over the course of three months. The groups will be closed, in that no new members will be allowed to join after the first week in order to promote open self-disclosure and trust among group members."
15924258|NCT03464409|Other|Semi-structured interview|Semi-structured interviews to be conducted by a study team member.
15924839|NCT03460145|Other|Strip without Lavender Oil (Px)|Strip without Lavender Oil (Px)
15924259|NCT03464409|Other|Spinal Cord Independence Measure (SCIM-SR)|The Spinal Cord Independence Measure - Self Report (SCIM-SR) is a self-report instrument for assessing functional independence of persons with spinal cord injury.
15924260|NCT03464409|Other|SF-36|A health-related quality of life (QoL) self-reported survey.
15924261|NCT03464396|Other|Bedside Physiology study|A 90-minute recording in conjunction with the respiratory evaluations using standard recording equipment that includes a conventional pulse oximeter, an EEG, an airflow sampling catheter near the nose, and respiratory inductance plethysmography (RIP) bands. Standard clinical bedside monitoring will continue during the respiratory evaluations.
15924262|NCT03464396|Other|Carotid Body Function Test|Infants without nasal cannula will have a nasal cannula placed in their nares. After a 15-minute baseline period and during quiet sleep, the infant will then be exposed to 30 seconds of 100% oxygen (O2) by increasing FiO2. This test will be repeated 3 times, with at least 3 minutes between tests to allow for return of oxygen saturation (SpO2) to baseline values. If oxygen saturations increase to 99% for 15 seconds or the infant is apneic for greater than 5 seconds following initiation of 100% oxygen (O2), the test will be stopped and FiO2 brought back to baseline. Infants in the NICU will be monitored continuously with heart rate, respiratory rate, and SpO2% for 12 hours after Carotid Body Function Test according to NICU standards. Infants discharge who return for Carotid Body Function Test at 40 and 52 weeks PMA will be monitored continuously for 1 hour after the test is finished.
15924263|NCT03464396|Other|Room Air Challenge|Infants receiving nasal cannula high flow support 3 liters per minute (LPM) or less with or without supplemental O2 at 36 weeks PMA will be eligible. After a 15-minute quiet sleep period, infants' FiO2 will be weaned, in 0.20 decrements for 5 min intervals. Flow then decreased in 10 min intervals, initially in 1 Liter Per Minute (LPM) decrement until nasal cannula flow is 1LPM, and then decreased by 50% decrements to 0.125 LPM then off. If the infant is weaned to room air alone for 15 minutes, not meeting failure criteria, he/she has passed the RAC. Failure of the RAC is defined as occurring when SpO2% falls below 80%, even briefly, or remains less than 90% for 5 consecutive minutes any time during the test, bradycardia (Heart rate [HR] < 80 bpmx 10 sec) or persistent apnea despite stimulation. Infant is returned to the level of support provided before the RAC begun if meets any failure criteria.
15924264|NCT03464396|Other|Hypoxia Challenge Test|"A physician investigator will review 30 minutes of continuous recording made 24 hours prior to test scheduled to identify infants that are at high risk for significant oxygen desaturations during Hypoxemia Challenge.
~If subject passes the screening test, the hypoxic challenge will be performed. For the hypoxemia test, a nasal cannula will be placed prior to a 15 minute period of quiet sleep recorded to confirm antecedent stability of ventilatory pattern and SpO2%. During the 15 minutes of quiet sleep, the infant is required to maintain a SpO2 of > 92% in order to undergo the HCT. After the 15-minute baseline recording, HCT will begin using FiO2 = 0.18 for 5 minutes, unless failure criteria is met: SpO2% < 80% even briefly, or SpO2% 80% to 85% for 15 seconds. If infant does not meet failure criteria, infant will be given FiO2 0.15 for 10 minutes. If an infant meets even a single criterion for failure, Hypoxic mixture will be stopped."
15924265|NCT03464396|Other|Effects of Nasal Cannula Flow|"Infants will have nasal catheter in place (NeoTech Premature RAM Cannula). A 15-minute baseline recording of physiologic study parameters prior to initiation. Tested in three groups of infants.
~28 and 32 weeks PMA flow rates increased after a 15-minute baseline period to 3LPM, or by 1LPM to a max of 5LPM for 15 minutes. Infant on Bubble CPAP will be increased 1cm H2O to max 8 cm H2O for 15 minutes.
~Infant's that fail the RAC or HCT at 36 weeks with periodic breathing, high flow at 3LPM will be started for 2 minutes or until periodic breathing stops. Infants on Bubble CPAP will not undergo the RAC or HCT. Their pressure is increased by 1cm H20 to max of 8 cm H2O for 15 minutes.
~Infant on RA at 40 and 52 weeks PMA with periodic breathing lasting longer than 1 minute during the 15-minute baseline period, flow at 3LPM will be started for 2 minutes or until periodic breathing stops."
15924266|NCT03464396|Diagnostic Test|Magnetic Resonance Imaging|A non-sedating MRI scan will be performed on 3 subsets of infants at 37-40 weeks Post Menstrual Age (PMA), or when infant is within one week of discharge from the NICU. Standard images as well as research images will be obtained. The research images use the same MRI scanner and collection techniques as standard clinical imaging, but provide a more detailed examination of brain anatomy and injury. Collection of these sequences using our standard non-sedated acquisition practices for infants is well tolerated. Infants will be placed in scanner by registered nurse accompanied by radiology technician to assure infants' comfort during scan. Infant will remain on cardio-respiratory monitor during MRI via a pulse oximetry probe. It will take no longer than one hour to complete MRI scan including transportation to radiology unit.
15924267|NCT03464396|Diagnostic Test|Echocardiogram|An echocardiogram (referred to as an ultrasound of the heart on the consent form) will be performed to assess cardiac structure and function. Echocardiograms are performed routinely in premature newborns in the NICU. The Echocardiogram will be performed at the infant bedside and will be coordinated with bedside nurse. The infant will remain on a cardio-respiratory monitor during the echocardiogram for approximately 15 minutes.
15924268|NCT03464396|Other|Blood Sample|Infants that have echocardiograms will have a blood sample collected near the time the echocardiogram is obtained, 3-blood samples total. The blood sample will only be collected with parental permission on an opt-in or out-basis and collected only with routine clinical labs.
15924269|NCT03464383|Drug|Escitalopram 10mg|Participants will be given escitalopram 10mg by mouth daily and will be followed up with at 2, 4, 6, 8, and 10 weeks. Medication will be adjusted if side effects occur. If unable to tolerate escitalopram, then venlafaxine XR (Effexor XR) 37.5mg will be substituted.
15924270|NCT03464383|Other|Referral to Psychiatry|Participants randomized to control will have a psychiatry referral order placed by the treating epileptologist under typical care circumstances. This will be an internal or external referral order based on patient preference. If external, the order will be printed along with instructions for the patient to follow to find a provider covered by insurance.
15924271|NCT03464383|Other|Survey only|One time survey will be offered to individuals who are found to have anxiety or depression symptoms on screening but who are ineligible for the treatment component of the study, or who decline the treatment study.
15924298|NCT03464175|Device|Heated-humidified circuit|It will be turned off 15 minutes before the transfer in the Nuclear Medicine Department in group 2 (nebulization performed 30 minutes after turning off the heated-humidifier).
15924299|NCT03464175|Device|Dry ventilator circuit specific for aerosol therapy|Streamlined components, integrated T-piece for the nebulizer at 15 cm of the Y piece
15924272|NCT03464370|Other|Measure of emotional stressors|"For the Epileptic Group
~Rapid interrogation, completing the clinical data
~A scale of impact of the precipitating factors of crises
~An emotional Stroop
~A task of detecting emotional targets against threatening information
~A measure of the perception of emotions using film clips
~A scale of measurement of perceived stress
~The transfer of psychiatric scales
~For the healthy volunteers group :
~A rapid interrogation, gathering the possible medical history, the level of studies, the manual laterality
~An emotional Stroop
~A task of detecting emotional targets against threatening information
~A scale of measurement of perceived stress
~A measure of the perception of emotions using film clips
~A rapid neuropsychological assessment"
15924273|NCT03464357|Radiation|fMRI|"The BOLD (Blood-Oxygen-Level Dependent) signal obtained by fMRI reflects the rate of oxygenation of the blood in the brain. However, the hemodynamic response that corresponds to an inflow of oxygenated blood increases in regions that consume energy. Thus, it is possible, by the study of the BOLD signal, to know with a great precision the regions of the brain specially active during a given task.
~The recorded signals reflect a neuronal activation. For each eye, recordings with and without flash visual stimulation are performed alternately."
15924274|NCT03464344|Other|neurological, neuropsychological and MRI evaluation|neurological, neuropsychological and MRI evaluation
15924275|NCT03464331|Behavioral|Zero-time exercises|The Investigators/research staff (RS) will help EXP download, operate the Zero-time exercises (ZTE) app and ZTE e-diary. The EXP can enter their goal for the chosen exercise by setting the target duration or number of completed repetitions, review their previous record, and compare their exercise frequency and time ranking with those of the other EXP. After the EXP uploads the goal and results to the ZTE e-diary, the data will be automatically sent to the ZTE app database for data analysis. The EXP will be given a paper diary to record their Zero-time exercises (ZTE). Twenty-five EXP will be given activity trackers (e.g. Fitbit) to record their steps/motion throughout the 3 months.
15924276|NCT03464331|Behavioral|relaxation exercises and deep-breathing exercises|The Investigators/RS will teach the CON group (CON) to do relaxation exercises (RE) and deep-breathing exercises (DBE) for at least 30 mins every day. They will be helped download and use the electronic diary (CON_e-diary) to record their RE and DBE. The CON will also be given a paper diary to record RE and DBE they have done if they prefer to use paper diary.
15924277|NCT03464305|Drug|acetylsalicylic acid|Patients treated with acetylsalicylic acid 80 mg once daily for 5 years. Patients will be stratified according to the admission of adjuvant chemotherapy.
15924278|NCT03464305|Drug|Placebo|Patients treated with placebo. Patients will be stratified according to the admission of adjuvant chemotherapy.
15924279|NCT03464292|Drug|Capsaicin Patch 8% or 0.1% Capsaicin Cream|0.1 ml of 8% capsaicin topical patch or 0.1% capsaicin cream
15924280|NCT03464292|Other|Vehicle Patch|Control patch will be the same topical solution but will not contain capsaicin.
15924281|NCT03464279|Behavioral|Nudge using Behavioral Economic Interventions|
15924282|NCT03464279|Behavioral|Standard Practices to Reduce Health System Antibiotic Prescription|
15924283|NCT03464266|Combination Product|FTC/TDF and DMPA|The primary analysis will be separate comparisons of the annualized rates of change in BMD and TBS of the spine and hip between women using PrEP and DMPA concurrently versus women using DMPA only (comparison 1), women using PrEP only (comparison 2), and women using neither (comparison 3). Analyses will account for baseline BMD.
15924284|NCT03464266|Drug|FTC/TDF|The primary analysis will be separate comparisons of the annualized rates of change in BMD and TBS of the spine and hip between women using PrEP and DMPA concurrently versus women using DMPA only (comparison 1), women using PrEP only (comparison 2), and women using neither (comparison 3). Analyses will account for baseline BMD.
15924285|NCT03464266|Drug|DMPA|The primary analysis will be separate comparisons of the annualized rates of change in BMD and TBS of the spine and hip between women using PrEP and DMPA concurrently versus women using DMPA only (comparison 1), women using PrEP only (comparison 2), and women using neither (comparison 3). Analyses will account for baseline BMD.
15924286|NCT03464266|Other|Neither DMPA nor FTC/TDF|The primary analysis will be separate comparisons of the annualized rates of change in BMD and TBS of the spine and hip between women using PrEP and DMPA concurrently versus women using DMPA only (comparison 1), women using PrEP only (comparison 2), and women using neither (comparison 3). Analyses will account for baseline BMD.
15924287|NCT03464253|Device|Performance of the transcranial Doppler (TCD)|Within 24 hour before the operation, TCD is performed using Siemens Acuson X300 machine with ultrasound frequency is 1 - 5 MHz probe to measure Mean Velocity and Pulsatility Index in the right middle cerebral artery.postoperatively, TCD study is performed twice at 24h and 48h after spinal anesthesia. For 5 days postoperatively, the Patients are assessed clinically for the occurrence of headache. Patients who developed PDPH will be identified and their pre and post puncture measurements will be compared with the corresponding measurements of PDPH free patients.
15924288|NCT03464240|Dietary Supplement|Glucose|glucose drink
15924289|NCT03464240|Dietary Supplement|Water|control
15924290|NCT03464227|Drug|UCB0107|"Pharmaceutical form: solution for infusion
~Route of administration: intravenous use"
15924291|NCT03464227|Other|Placebo|"Pharmaceutical form: intravenous infusion
~Route of administration: intravenous use"
15924292|NCT03464214|Device|Neck Muscle Vibration|Local vibration device applied on neck muscles for 8 weeks
15924293|NCT03464214|Behavioral|Cervical Stabilization Exercises|Cervical stabilization exercises performed by healty individuals for 8 weeks
15924294|NCT03464201|Drug|Enzalutamide 40 MG|Enzalutamide 160 mg p.o. every day
15924295|NCT03464188|Behavioral|Project Cornerstone|"Project Cornerstone basic elements are:
~The intervention is lay navigator-led with regular supervision by a specialist palliative care clinician;
~6 base telephone/in-person sessions: Sessions cover specific topics (every 1-2 weeks, 20-60 minutes/session; by phone or in-person), followed by monthly follow-up and additional coaching sessions as needed;
~Regular caregiver distress thermometer screening and problem support and self-care coaching.
~Caregivers receive a Project Cornerstone Family Supporting Family (FSF) Binder that organizes intervention materials and contains educational information pertaining to the 6 base coaching sessions. Project Cornerstone begins within 60 days of a care recipient being diagnosed with advanced cancer and ends 1 year after care recipient death."
15924296|NCT03464175|Device|Aerogen Solo®|Aerosol particles are generated by a vibrating-mesh nebulizer specifically designed for mechanical ventilation
15924840|NCT03460145|Drug|Propofol 1 % Injectable Suspension|Propofol 1% (10mg/mL)
15924300|NCT03464175|Device|Conventional dry ventilator circuit with HME filter|The nebulizer is placed between the filter and the endotracheal tube.
15924301|NCT03464162|Behavioral|Social Network Meetings|Social Network Meetings are a type of family therapy that includes clients and members of their social network.The social network may include family members, friends or anyone else that clients believe can help them move toward recovery. The meetings will focus on improving communication within the social network.
15924302|NCT03464149|Diagnostic Test|One armed study, blood from each patient is analysed by four assays ( two 3rd generation and two 2nd generation assays)|Intact PTH Assay (Siemens Healthcare Diagnostics Inc); LIAISON 1-84 PTH Assay (Diasorin); PTH (1-84), biointact (Roche Diagnostics); PTH, intact (Roche Diagnostics)
15924303|NCT03464136|Biological|Placebo for Ustekinumab|Participants will receive placebo as SC injection to blind adalimumab.
15924304|NCT03464136|Biological|Placebo for Adalimumab|Participants will receive placebo as IV infusion to blind ustekinumab.
15924305|NCT03464136|Biological|Ustekinumab (6 mg/kg)|Participants will receive ustekinumab 6 mg/kg (weight based dosing) as IV infusion.
15924306|NCT03464136|Biological|Ustekinumab (90 mg)|Participants will self-administer SC injection of ustekinumab 90 mg.
15924307|NCT03464136|Biological|Adalimumab (40 mg)|Participants will self-administer multiple SC injections of adalimumab (each 40 mg) and will receive total dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg q2w from Week 4 to 56.
15924308|NCT03464123|Other|Standard cardiopulmonary resuscitation|Standard Advanced Life Support based on guidelines 2015, including mechanical chest compression device
15924309|NCT03464110|Behavioral|Communication Intervention|. The intervention will contain elements of Motivational Interviewing coaching but also will teach providers how to address patient emotion and increase the efficiency of their visits. Clinicians randomized to the intervention will receive a tailored communication coaching intervention that includes didactic elements, audio recording encounters and providing feedback, and role-playing.
15924310|NCT03464097|Drug|Ozanimod|Ozanimod
15924311|NCT03464097|Other|Placebo|Placebo
15924312|NCT03464084|Drug|placebo|Capsules containing microcrystalline cellulose
15924313|NCT03464084|Dietary Supplement|melatonin|5 mg of melatonin per os.
15924314|NCT03464084|Other|bright light|room light will be bright
15924315|NCT03464084|Other|dim light|room light will be dim
15924316|NCT03464071|Device|Hyperinflation with mechanical ventilator|increase in initial positive inspiratory pressure until reaching a peak pressure of 40 cmH2O and PEEP equal to 7 cmH2O
15924317|NCT03464071|Device|Manual hyperinflation|the manual resuscitation bag will be connected to the oxygen system at five liters per minute. The participant will be disconnected from the ventilator and then initiate a slow inspiration with inspiratory pause followed by abrupt expiration, totaling twelve (12) cycles / minute.
15924318|NCT03464058|Drug|BOS172767 tablets|Oral tablets
15924319|NCT03464058|Drug|BOS172767 liquid capsules|Oral capsules
15924320|NCT03464058|Drug|BOS172767 micronized capsules|Oral capsules
15924321|NCT03464058|Drug|BOS172767 immediate release capsules|Oral capsules
15924322|NCT03464058|Drug|BOS172767 matching placebo capsules|Oral capsules
15924323|NCT03464058|Drug|BOS172767 matching placebo tablets|Oral tablets
15924324|NCT03464058|Drug|Rabeprazole|Oral tablets
15924325|NCT03464045|Drug|empagliflozin|drug
15924326|NCT03464045|Drug|DPP-4 inhibitors|drug
15924327|NCT03464045|Drug|SGLT-2 inhibitors|drug
15924328|NCT03464032|Drug|BCD-135|Monoclonal anti-PD-L1 antibody
15924329|NCT03464019|Drug|Etripamil|Etripamil will be administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.
15924330|NCT03464019|Drug|Placebo|Placebo will be administered via the Aptar Pharma Nasal Spray Bidose System, supplied as prefilled devices packaged into child-resistant boxes with instructions for use provided in the study drug box.
15924331|NCT03464006|Other|Online Support Module|The online support module is a computer software program which helps patients monitor factors related to their peripheral artery disease
15924332|NCT03464006|Other|Standard of Care|The normal care that patients receive at the institution.
15924333|NCT03463993|Drug|Tranexamic Acid|TXA (10mg/kg) solution for injection from the vial will be diluted with 100 - 200ml electrolyte solution such as Normal Saline, Ringers solution, dextrose/water for injection on the same day it is to be used (i.e. when anaesthetist notes the patient has been randomized to receive TXA). Intravenous administration should be at a rate of 100mg or fraction thereof over at least 1 minute - usually at least 5 minutes. Standard practice is to administer over 20 minutes. Administration is to be done at least 10 minutes prior to skin incision.
15924334|NCT03463993|Drug|Oxytocin|5IU of oxytocin are administered intravenously slowly once the baby has been delivered at caesarean section.
15924335|NCT03463980|Behavioral|Compassion meditation (CM)|CM session: 30 minute check-in regarding the participants' levels of suicidal ideation, as well as a discussion of current life stress and weekly meditation practice; a 30 minute didactic session that will describe the meditative technique introduced during the week; and a 30 minute guided meditation session. Participants are also encouraged to meditate at least 30 minutes a day.
15924336|NCT03463980|Behavioral|Support group (SG)|SG session: 90 minutes to talk about current concerns and to receive support and guidance from other group members and the leaders.
15924337|NCT03463967|Dietary Supplement|Lycopene-enriched tomato juice|Energy-restricted diet supplemented with Lycopene-enriched tomato juice
15924338|NCT03463967|Other|Energy-restricted diet|
15924339|NCT03463954|Device|Novilase Laser ablation|Image-guided, percutaneous laser ablation of breast tumors
15924373|NCT03463733|Drug|Temozolomide|85622-93-1 /TEMOZOLOMIDE/TEMOZOLOMIDE/based on myeloproliferative disorders (MPD) record: SUB10889MIG
15924374|NCT03463720|Other|Infected|Extremity wound, infected
15924375|NCT03463720|Other|Not infected|Extremity wounds, non-infected
15924376|NCT03463707|Drug|BP101|Investigational product BP101, nasal spray
15924377|NCT03463707|Drug|Placebo|Placebo to Investigational product BP101, nasal spray
15924378|NCT03463694|Other|Na Cl solution|~2.6% NaCl solution prepared from sea salt
15924379|NCT03463681|Drug|Cabometyx|cabozantinib 60 mg orally once daily
15924340|NCT03463941|Behavioral|Peer Support Dyad Intervention|"Phase I: At baseline and at post-intervention, participant height, weight, BMI, fruit and vegetable intake and exercise habits will be measured. Participants will complete surveys and meet each week to learn about nutrition and exercise.
~Phase II: Dyads will attend a communication training session to discuss 1) benefits of working with a partner; 2) supportive communication tips; and 3) expected activities for the next 8 weeks, including filling out daily logs. After the training session, the dyads will work together to achieve their health goals. The dyads will return to the church for two check in sessions. At these sessions, participants will turn in their logs, and be weighed. At the end of the intervention, BMI will be reassessed, and surveys and interviews will be completed."
15924341|NCT03463928|Biological|donor-derived CD19/22 bispecific CAR-T cells or CD19-directed CAR-T cells; donor-derived-HSCT|The allo-CAR-T cells will be infused in a fractionated manner, 1/3 on day 0, 2/3 on day 1.The allo-HSCT will be infused on day 2.
15924342|NCT03463915|Drug|Bladder instillation WITH triamcinolone acetonide|Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), 0.5% bupivacaine (10 mL of 5 mg/mL) plus triamcinolone acetonide (1 vial, 40 milligrams (mg)/1 milliliters (mL).
15924343|NCT03463915|Drug|Bladder instillation WITHOUT triamcinolone acetonide|Bladder instillation mixture of heparin (10,000 units), 2% viscous lidocaine (10 mL), 8.4% sodium bicarbonate (15 mL of 1 mEq/mL), and 0.5% bupivacaine (10 mL of 5 mg/mL).
15924344|NCT03463902|Device|left IFG anodal|"Single session of transcranial direct current stimulation (tDCS) over left IFG anodal stimulation
~2 mA Stimulation of 10 min, anodal electrode over left IFG, cathodal electrode over right IFG, 30 sec ramp to start and 30 sec ramp to stop"
15924345|NCT03463902|Device|left IFG cathodal|"Single session of transcranial direct current stimulation (tDCS) over left IFG cathodal stimulation
~2 mA Stimulation of 10 min, cathodal electrode over left IFG, anodal electrode over right IFG, 30 sec ramp to start and 30 sec ramp to stop"
15924346|NCT03463902|Device|left IPL anodal|Single session of transcranial direct current stimulation (tDCS) over left IPL anodal stimulation 2 mA Stimulation of 10 min, anodal electrode over left IPL, cathodal electrode over right IPL, 30 sec ramp to start and 30 sec ramp to stop
15924347|NCT03463902|Device|left IPL cathodal|Single session of transcranial direct current stimulation (tDCS) over left IPL cathodal stimulation 2 mA Stimulation of 10 min, anodal electrode over left IFG, cathodal electrode over right IFG, 30 sec ramp to start and 30 sec ramp to stop
15924348|NCT03463902|Device|Placebo|Single session of placebo tDCS over left IFG 10 min duration, 30 sec ramp during start and end
15924349|NCT03463889|Drug|Gallium Ga 68-labeled PSMA-11|Given IV
15924350|NCT03463889|Procedure|Magnetic Resonance Imaging|Undergo MRI in combination with PET
15924351|NCT03463889|Procedure|Positron Emission Tomography (PET)|Undergo PET in combination with MRI
15924352|NCT03463876|Drug|SHR 1210+apatinib|SHR-1210 200mg (3mg/kg for underweight patients) iv every 2 weeks;Apatinib,250 mg/day.
15924353|NCT03463863|Procedure|rectus sheath midurethral sling|
15924354|NCT03463850|Radiation|Dual Energy CT (DECT)|Dual Energy CT (DECT)
15924355|NCT03463850|Radiation|DEXA|Dual-energy x-ray absorptiometry for measurement of bone mineral density
15924356|NCT03463837|Other|Treatment with JUUL 5%, Virginia Tobacco|JUUL 5%, ENDS for 5-days in confinement
15924357|NCT03463837|Other|Treatment with JUUL 5%, Cool Mint, ENDS|JUUL 5%, ENDS for 5-days in confinement
15924358|NCT03463837|Other|Treatment with JUUL 5%, Mango, ENDS|JUUL 5%, ENDS for 5-days in confinement
15924359|NCT03463837|Other|JUUL 5%, Creme Bruele, ENDS|JUUL 5%, ENDS for 5-days in confinement
15924360|NCT03463837|Other|Combustible cigarette|Exclusive use of combustible cigarette for 5 days in confinement.
15924361|NCT03463837|Other|Smoking Cessation|No smoking for 5-days in confinement.
15924362|NCT03463824|Behavioral|Experimental Group 1|Participants will complete 18 intervention visits over 9 weeks with the number of sessions tapered across weeks (i.e., 3 sessions/week in weeks 1-3, 2 sessions/week in weeks 4-6, and 1 session/week in weeks 7-9).
15924363|NCT03463824|Behavioral|Experimental Group 2|Participants will complete 18 intervention visits over 9 weeks with the number of sessions tapered across weeks (i.e., 3 sessions/week in weeks 1-3, 2 sessions/week in weeks 4-6, and 1 session/week in weeks 7-9).
15924364|NCT03463811|Diagnostic Test|Lactate concentration in vaginal fluid|Lactate concentration in vaginal fluid
15924365|NCT03463798|Device|Sonar|Measurements of chest wall and abdominal wall movement will be performed while subjects are breathing quietly
15924366|NCT03463798|Device|Structured light plethysmography (SLP)|Measurements of chest wall and abdominal wall movement will be performed while subjects are breathing quietly
15924367|NCT03463785|Other|cone beam computed tomography|The CBCT data sets of both the Chinese and Dutch OSA patients will be obtained using a NewTom 5G CBCT system (QR systems, Verona, Italy), according to the standard imaging protocol.
15924368|NCT03463772|Procedure|standard IVF|Ovarian stimulation will be performed by a standard protocol using gonadotrophin-releasing hormone antagonist (GnRH-ant) in association with recombinant FSH (rFSH) and human chorionic gonadotrophin (hCG).Oocyte retrieval is scheduled for 36 (±2) after hCG injection.The retrieved cumulus oocyte complexes (COC) will be inseminated using ICSI or conventional IVF according to the seman analysis. All embryos will be cultured to blastocyst stage and be vitrified.
15924369|NCT03463772|Drug|In vitro maturation|Controlled ovarian stimulation protocol will not performed in this group patients. Transvaginal ultrasound scanning was examined on natural cycle to monitor the follicle size in group B participants. Oocyte retrieval was scheduled once the endometrium had reached at least 6 mm in thickness and there was no follicle larger than 10 mm. After oocyte retrieval, the COCs will be cultured for 28-32h in special IVM media in order to get the matured oocytes. All the metaphase II (MII) oocytes were inseminated by means of intracytoplasmic sperm injection (ICSI). All embryos will be cultured to blastocyst stage and be vitrified.
15924370|NCT03463746|Device|LYRA® gait trainer|The EG will get standard individual physical therapy (5x/week, 45min) whereby three sessions of electromechanical-assisted gait training on LYRA® gait trainer.
15924371|NCT03463746|Device|Standard individual physical therapy|The CG will get standard individual physical therapy (5x/week, 45min) without any instrument-based locomotion therapy (i.e. treadmill training, electromechanical/robot-assisted gait training).
15924372|NCT03463733|Drug|Hydroxyurea|147-94-4/HYDROXYCARBAMIDE/HYDROXYCARBAMIDE/based on myeloproliferative disorders (MPD) record: SUB08076MIG
15924380|NCT03463668|Device|uncovered metal duodenal prosthesis|Implantation of an uncovered metal duodenal prosthesis for symptomatic tumor stenosis
15924381|NCT03463655|Diagnostic Test|cirrhotic albumin|Ascites puncture
15924382|NCT03463655|Diagnostic Test|serum albumin|blood punctures
15924383|NCT03463642|Dietary Supplement|vitamin D3|100,000IU
15924384|NCT03463642|Dietary Supplement|Pill|Dicalcium phosphate, microcrystalline cellulose, silicium dioxide, magnesium stearate
15924385|NCT03463642|Dietary Supplement|orange syrup|100 drops orange syrup
15924386|NCT03463642|Other|mineral oil|Paraffinum Liquidum,Isopropyl Palmitate,Parfum
15924387|NCT03463642|Dietary Supplement|Penetrator|Tangerine essential oil (10ml)
15924388|NCT03463629|Other|Specialized multidisciplinary diabetes team (SMDT) approach|"The implementation of the pilot study will consist of a specialized multidisciplinary diabetes team care (SMDT) that includes endocrinologists, a nurse practitioner, dieticians, pharmacists and a licensed professional counselors (LPCs) to collaborate and coordinate care. Subjects in the pilot study will follow a multidisciplinary team approach process with the following team members: pharmacist, LPC, and dietician.
~There will be 3 individualized visits: 1 visit with the counselor (LPC), 1 visit with the Pharmacist, and 1 visit with the Dietician.
~In addition, a follow up phone call post visit, that can range from 5 to 30 minutes, will be scheduled from each of the team members during the study. Also, throughout the pilot study participant's blood glucose readings will be monitored weekly via a transmittable wireless patient transmission monitor."
15924389|NCT03463629|Other|Traditional model of care|Receive the traditional model of care, but will not receive diabetes education by pharmacists or counseling services
15924390|NCT03463616|Radiation|CT abdomen|CT scan of abdomen for metastasis staging of rectal cancer
15924391|NCT03463616|Radiation|MRI abdomen|MRI of abdomen for metastasis staging of rectal cancer
15924392|NCT03463590|Device|Bilateral surgical implantation of DBS system to habenula|The DBS device utilized in the present study may include the Medtronic, PINS and SceneRay DBS device depending on patients' choice.
15924393|NCT03463577|Other|Safety assessment following routine immunization with Boostrix|Subject-level data will be collected for pregnant women and their infants through the Electronic Health Records.
15924394|NCT03463564|Device|Insulin pump|Continuous subcutaneous insulin infusion consisting of the delivery of insulin lispro as basal rate and boluses administered before meals.
15924395|NCT03463564|Drug|Insulin injections|Four injections of insulin daily consisting in three bolus of a rapid-acting analog lispro or aspart before breakfast, lunch and dinner and one injection of insulin glargine or degludec at bed-time of basal insulin
15924396|NCT03463551|Drug|ABL-101|ABL-101 is provided as a sterile phospholipid-based emulsion for intravenous administration.
15924397|NCT03463551|Other|0.9% NaCl|Placebo
15924398|NCT03463538|Procedure|arthroscopic capsular release|surgical release of shoulder joint capsule
15924399|NCT03463538|Procedure|Hydro-dilatation|dilatation of shoulder joint capsule using water pressure under local anesthetic
15924400|NCT03463525|Drug|Osimertinib|Osimertinib 80 mg once daily p.o. will be taken continuously by the patient from the day of the second PET exam.
15924401|NCT03463525|Drug|[11C]osimertinib|Patients will receive 3 single IV microdose administrations of [11C]osimertinib and PET exams on: Day 1, Day 2 (or up to Day 8) and Day 29.
15924402|NCT03463512|Drug|Racecadotril plus ORS|Racecadotril plus ORS
15924403|NCT03463512|Drug|ORS|ORS
15924404|NCT03463499|Drug|Hyaluronic Acid and Chondroitin Sulfate|Intravesical instillation of Hyaluronic Acid and Chondroitin Sulfate After Transurethral Resection of Hunner Lesion in Interstitial Cystitis/Bladder Pain Syndrome Patients.
15924405|NCT03463486|Behavioral|Physical activity|50min of endurance training combined with 50min of calisthenics; 1-3x/wekk; 6weeks up to 1year
15924406|NCT03463473|Drug|MSB2311 Injection|An intravenous infusion with concentration from 0.3 mg/kg to 20 mg/kg every 3 weeks (Q3W).
15924407|NCT03463460|Other|Laboratory Biomarker Analysis|Correlative studies
15924408|NCT03463460|Biological|Pembrolizumab|Given IV
15924409|NCT03463460|Drug|Sunitinib Malate|Given PO
15924410|NCT03463447|Device|Electronic Dynamometer|Mensuration of the handgrip strength of each volunteer using an electronic dynamometer.
15924411|NCT03463447|Device|Hydraulic dynamometer|Mensuration of the handgrip strength of each volunteer using a hydraulic dynamometer.
15924412|NCT03463434|Device|Air Fluidized Therapy|AFT bed used for pressure injury treatment
15924413|NCT03463434|Device|Continuous Low Pressure-LAL|Continuous Low Pressure/Low Air Loss Mattress for Pressure injury treatment
15924414|NCT03463408|Drug|nivolumab|240 mg every 2 weeks
15924415|NCT03463408|Drug|ipilimumab|1 mg/kg every 6 weeks
15924416|NCT03463395|Device|Reza band|Reza band, a non-medication, non-surgical medical device designed to reduce symptoms of LPR has recently been approved by the FDA. It works by stopping the flow of gastric contents through the upper esophageal sphincter (UES) by increasing the internal pressure of the UES
15924417|NCT03463382|Procedure|Erector Spinae Plane Block|Erector Spinae Plane block will be administered under general anesthesia before the surgery
15924418|NCT03463382|Procedure|Quadratus Lumborum Block|Quadratus Lumborum Block will be administered under general anesthesia before the surgery
15924419|NCT03463382|Drug|Bupivacaine (Block Drug)|0,25% Bupivacaine was used 0,5ml/kg (max. 20cc) for block performances
15924420|NCT03463369|Biological|JNJ-64300535|Participants will receive JNJ-64300535 vaccine by electroporation-mediated IM injection on Day 1, Week 4, and Week 12.
15924421|NCT03463369|Biological|Placebo|Participants will receive 1 mL (0.9 percent [%] sodium chloride [NaCl]) of placebo solution matching to JNJ-64300535 electroporation-mediated IM injection on Day 1, Week 4, and Week 12.
15924422|NCT03463369|Drug|Nucleos(t)ide Analogs (NA)|Participants will receive NA as a standard of care treatment.
15924423|NCT03463356|Behavioral|Shame Intervention|In the Shame Intervention, participants will meet with a therapist and learn to: 1) Recognize the experience of shame, 2) Understand the connection between shame and social anxiety, 3) Identify shame triggers and vulnerabilities, 4) Identify the thoughts and behaviors that keep participants stuck in shame, and 5) Learn how to use new, healthier thoughts and behaviors that will help participants move through and decrease shame.
15924471|NCT03463122|Other|conventional therapy|conventional therapy for stroke rehabilitation
15924424|NCT03463343|Other|Cervical spine manual manipulation|In the Manual manipulation group, the thrust was applied in the right side of C3/C4 with neutral flexion/extension, ipsilateral side bending and contralateral rotation. Then, a low amplitude, high velocity thrust in rotation was delivered.
15924425|NCT03463343|Other|Cervical spine mechanical manipulation|In the Mechanical manipulation group, the Activator instrument was applied on the right transverse apophyses of C3.
15924426|NCT03463343|Other|Placebo intervention|The subjects were positioned in the same pre-manipulative position as the manual manipulation group, but the thrust didn't occur. Instead, the position was hold for 3 seconds and then the subject's head returned passively to neutral position.
15924427|NCT03463330|Behavioral|Qigong exercise|The Qigong exercise is a series of mild exercise movements.
15924428|NCT03463330|Behavioral|Mild body exercise|Participants will be taught of series of similar movements to the Qigong exercise.
15924429|NCT03463317|Device|CE-mark approved LAA closure devices|LAA closure with post procedure treatment
15924430|NCT03463317|Drug|Acetylsalicylic acid|post procedure treatment according to the physicians (recommendation are made in the protocol); oral anticoagulation is not prescribed in this group
15924431|NCT03463317|Drug|Clopidogrel|post procedure treatment according to the physicians (recommendation are made in the protocol); oral anticoagulation is not prescribed in this group
15924432|NCT03463317|Drug|Dabigatran|Patients allocated to the best medical care group receive either NOAC therapy or VKA
15924433|NCT03463317|Drug|Rivaroxaban|Patients allocated to the best medical care group receive either NOAC therapy or VKA
15924434|NCT03463317|Drug|Apixaban|Patients allocated to the best medical care group receive either NOAC therapy or VKA
15924435|NCT03463317|Drug|Edoxaban|Patients allocated to the best medical care group receive either NOAC therapy or VKA
15924436|NCT03463317|Drug|Phenprocoumon|Patients allocated to the best medical care group receive either NOAC therapy or VKA
15924437|NCT03463317|Drug|Warfarin|Patients allocated to the best medical care group receive either NOAC therapy or VKA
15924438|NCT03463291|Device|MRI|"T1 weighted image.
~Fast spin-echoT2 weighted image.
~Short inversion recovery (STIR).
~T1-fat suppressed images.
~Diffusion weighted sequences with different b values 0-1000 s/mm2 with qualitative assessments by the different b values as well as quantitative assessment by measurement of the ADC values."
15924439|NCT03463278|Diagnostic Test|Pregnancy Rate|The pregnancy and live birth rate according to number of blastocysts formed in our three groups
15924440|NCT03463265|Drug|ABI-009|ABI-009 as single agent or in combination with other agents
15924441|NCT03463265|Drug|Bevacizumab|bevacizumab
15924442|NCT03463265|Drug|Temozolomide|temozolomide
15924443|NCT03463265|Drug|Lomustine|lomustine
15924444|NCT03463265|Radiation|Radiation|radiation
15924445|NCT03463265|Drug|Marizomib|marizomib
15924446|NCT03463252|Drug|Progesterone|MPA oral 250mg-500mg qd for 3 months per cycle
15924447|NCT03463252|Device|Mirena®|levonorgestrel intrauterine sustained release system (LNG-IUS) placed in uterus for 3 months per cycle
15924448|NCT03463252|Drug|GnRH agonist|GnRH-a intramuscular injection 3.75mg once a month for 3 months per cycle
15924449|NCT03463239|Biological|Autologous tissue engineered corpora|penile tissue construct
15924450|NCT03463226|Diagnostic Test|Cardiopulmonary exercise test|Oxygen consumption (VO2) and carbon dioxide output (VCO2) were measured by means of gas exchange on a breath-by-breath basis. The patients were initially monitored for 2 minutes at rest when seated on the ergometer, after that they were instructed to pedal at a pace of 60-70 rpm and the completion of the test occurred when, in spite of verbal encouragement, the patient reached maximal volitional fatigue.
15924451|NCT03463226|Diagnostic Test|Muscle Sympathetic Nerve Activity|Multiunit post-ganglionic muscle sympathetic nerve recordings were made using a tungsten microelectrode placed in the peroneal nerve near the fibular head. Nerve signals were amplified by a factor of 50,000 to 100,000 and band-pass filtered (700 to 2000 Hz). For recording and analysis, nerve activity was rectified and integrated (time constant 0.1 seconds) to obtain a mean voltage display of sympathetic nerve activity.
15924452|NCT03463226|Diagnostic Test|Dual-energy X-ray absorptiometry|Dual-energy X-ray absorptiometry (DXA) scan was used to measure total lean mass, body fat and bone mineral content.
15924453|NCT03463226|Diagnostic Test|Venous occlusion plethysmography|Venous occlusion plethysmography was used to assess non-invasively blood flow.
15924454|NCT03463226|Diagnostic Test|Blood sample collection|Blood samples were drawn in the morning after 12h overnight fasting.
15924455|NCT03463226|Diagnostic Test|Dynamometers for Handgrip Strength|Muscle strength was assessed by handgrip dynamometer using the mean value of three attempts.
15924456|NCT03463213|Behavioral|SHE Tribe|Social network-based peer-facilitated intervention to promote adoption of health behavior
15924457|NCT03463200|Other|Functional elastic tape tensioned|Application of Kinesio Taping with tension in the erector spine muscles.
15924458|NCT03463200|Other|Functional elastic tape non-tensioned|Application of Kinesio Taping without tension in the erector spine muscles.
15924459|NCT03463200|Other|Rigid Tape|Application of Micropore tape in the erector spine muscles.
15924460|NCT03463187|Biological|SHR-1314|Administered subcutaneously
15924461|NCT03463187|Drug|Placebo|Administered subcutaneously
15924462|NCT03463174|Procedure|Mandibular overdenture|Placement of an implant in the mandibular midline.
15924463|NCT03463174|Other|Mandibular complete denture|No intervention.
15924464|NCT03463161|Drug|Pembrolizumab|Pembrolizumab (200mg/kg) given by intravenous infusion every 3 weeks.
15924465|NCT03463161|Drug|Epacadostat|Epacadostat (100mg) taken by mouth twice a day.
15924466|NCT03463135|Drug|Glucopyranosyl Lipid A (GLA)|Pharmaceutical form:Colloidal aqueous dispersion Route of administration: Sublingual
15924467|NCT03463135|Drug|Sublingual Immuno Therapy (SLIT) Peanut Extract (PE)|Pharmaceutical form:Solution Route of administration: Sublingual
15924468|NCT03463135|Drug|Placebo for GLA|Pharmaceutical form:Colloidal aqueous dispersion Route of administration: Sublingual
15924469|NCT03463135|Drug|Placebo for SLIT PE|Pharmaceutical form:Solution Route of administration: Sublingual
15924470|NCT03463122|Device|field of regard-focused visual exploration therapy|field of regard-focused visual exploration therapy in addition to conventional therapy
15924472|NCT03463109|Other|Electrocutaneous stimulation|Painful electrocutaneous stimuli will be randomly delivered to electrodes positioned in a random order on the participants' back. Participants will be instructed to draw with a stylus pen on a digital body chart displayed on a tablet where they will perceive each painful stimulation.
15924473|NCT03463109|Other|Assessment + Electrocutaneous stimulation|"Patients will be asked to provide information about their lifestyle, level of disability, actual pain and general pain, assessment of kinesiophobia and health status.
~Subsequently, painful electrocutaneous stimuli will be randomly delivered to electrodes positioned in a random order on the patients' back. Patients will be instructed to draw with a stylus pen on a digital body chart displayed on a tablet where they will perceive each painful stimulation."
15924474|NCT03463096|Other|High G acceleration on a long-arm human centrifuge|Gx (chest-to-back) and Gz (head-to-toe)
15924475|NCT03463083|Drug|Dexmedetomidine|"All cases of spine surgery will be done under G.A with the patient in prone position. After surgery an epidural catheter will be placed through a separate skin puncture above the incision The catheter will be positioned up to 7 cm from skin entry directing downwards in the epidural space . Once the patient in the post-operative room will be noted to have pain (VAS) of>4, the study will start. A test dose of 3 ml lignocaine with adrenaline will be injected the following parameters will be noted .
~The pain score, by using VAS
~Onset of analgesia (fall of VAS<4 ).
~Peak level of analgesia ( VAS score 0).
~Duration of analgesia (once the patient asks fwith VAS>4).
~Monitoring of NIBP, pulse rate, respiratory rate every 30 min.
~Side-effects such as nausea, vomiting, respiratory depression, Motor blockade Bromage scale>1 Also deep sedation Ramsay sedation scale>3 , And shivering and hypotension."
15924476|NCT03463083|Drug|Bupivacaine|"All cases of spine surgery will be done under G.A with the patient in prone position. After surgury an epidural catheter will be placed through a separate skin puncture above the incision The catheter will be positioned up to 7 cm from skin entry directing downwards in the epidural space . Once the patient in the post-operative room will be noted to have pain (VAS) of>4, the study will start. A test dose of 3 ml lignocaine with adrenaline will be injected the following parameters will be noted .
~The pain score, by using VAS
~Onset of analgesia (fall of VAS<4 ).
~Peak level of analgesia ( VAS score 0).
~Duration of analgesia (once the patient asks fwith VAS>4).
~Monitoring of NIBP, pulse rate, respiratory rate every 30 min.
~Side-effects such as nausea, vomiting, respiratory depression, Motor blockade Bromage scale>1 Also deep sedation Ramsay sedation scale>3 , And shivering and hypotension."
15924477|NCT03463083|Drug|Fentanyl|"All cases of spine surgery will be done under G.A with the patient in prone position. After surgury an epidural catheter will be placed through a separate skin puncture above the incision The catheter will be positioned up to 7 cm from skin entry directing downwards in the epidural space . Once the patient in the post-operative room will be noted to have pain (VAS) of>4, the study will start. A test dose of 3 ml lignocaine with adrenaline will be injected the following parameters will be noted .
~The pain score, by using VAS
~Onset of analgesia (fall of VAS<4 ).
~Peak level of analgesia ( VAS score 0).
~Duration of analgesia (once the patient asks fwith VAS>4).
~Monitoring of NIBP, pulse rate, respiratory rate every 30 min.
~Side-effects such as nausea, vomiting, respiratory depression, Motor blockade Bromage scale>1 Also deep sedation Ramsay sedation scale>3 , And shivering and hypotension."
15924478|NCT03463070|Drug|rectal misoprostol 600mg|70 women who received 600 mg misoprostol postoperatively at operating theatre
15924479|NCT03463057|Drug|Atezolizumab|Intervention Atezolizumab starts after 6 - 8 R-CHOP induction cycles (Rituximab, Cyclophosphamide, Hydroxo-doxorubicin, Vincristine and Prednisone (R-CHOP)); 18 cycles Atezolizumab followed by 12 months of observation
15924480|NCT03463044|Drug|nangibotide|Continous i.v. infusion
15924481|NCT03463044|Drug|Placebo|Placebo
15924482|NCT03463031|Drug|GSP 301 NS|1 spray in each nostril twice daily for 14 days
15924483|NCT03463031|Drug|GSP 301 Placebo NS|1 spray in each nostril twice daily for 14 days
15924484|NCT03463018|Dietary Supplement|Echinacea angustifolia|20 mg tablet of Echinacea angustifolia, standardized for echinacoside (not less than 3%) and alkamides (not less than 0.8%)
15924485|NCT03463018|Dietary Supplement|Placebo|Placebo tablet containing matching excipients to the active intervention
15924486|NCT03463005|Other|Royal jelly|The study subjects in the Royal jelly group used 10 ml of the vaginal Royal jell few minutes before and few minutes after intercourse one day after the end of menstruation for two weeks.
15924487|NCT03463005|Procedure|IUI|Subjects in IUI group received 75 units of FSH from the second day of the cycle.
15924488|NCT03462992|Diagnostic Test|MonoMark|MonoMark (also known under the registered trademark ColonoKit), is a monocyte-based test using a transcriptomic signature and a mathematical predictive model aimed at discriminating between healthy individuals and CRC patients.
15924489|NCT03462979|Device|Immunochromatographic lateral flow test|The immunochromatographic lateral flow test (Gluten Detective) is an at-home test that detects gluten immunogenic peptides excreted in stool or urine. This test can detect gluten exposures which occurred either during the last 24 hours (urine) or within up to a 7 day window (stool). Minimum intake amounts of gluten for successful detection using these test are 50mg (stool) to 500mg (urine)
15924490|NCT03462966|Drug|Rifaximin|Rifaximin will be administered to patients diagnosed with IBS-D or IBS-M to evaluate whether the medication is effective in decreasing rectal hypersensitivity. The secondary objective of the study is to assess the role of SIBO in rectal sensitivity.
15924491|NCT03462953|Procedure|Gingival tissue samples will be harvested|"Gingival tissue samples will be harvested during the premolar extraction (Orthodontic ttt) or third molar extraction for the healthy controls and during periodontal surgery or extraction of hopeless teeth with periodontal disease ..
~The dissected gingival samples will be washed in saline solution and fixed in 4% buffered formalin for 48 hours, dehydrated in ascending grades of ethyl alcohol, cleared in xylene and embedded in paraffin and will be subjected to the following:.
~Sections of 4-5 µm in thickness will be obtained, deparaffinized, rehydrated and subjected to histological staining and histomorphometric analysis.
~Real time- PCR for TGF-B1 ,Vimenten , E-Cadherin ."
15924492|NCT03462940|Dietary Supplement|Tauroursodeoxycholic acid|Tauroursodeoxycholic acid is an ambiphilic bile acid. It is the taurine conjugate form of ursodeoxycholic acid.
15924493|NCT03462927|Drug|MC2-01 Cream|MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%)
15924494|NCT03462927|Drug|CAL/BDP combination|Calcipotriene/betamethasone (calcipotriene/ betamethasone dipropionate, w/w 0.005%/0.064%)
15924552|NCT03462446|Drug|Rivaroxaban (Xarelto, BAY59-7939)|As prescribed by treating physicians
15924495|NCT03462901|Procedure|Percutaneous intramedullary fixation of displaced midshaft clavicular fractures .|A group of 15 patients admitted to Assiut university with midshaft clavicular fractures treated by operative fixation of the fracture by single elastic rod through medial approach under image intensifier
15924496|NCT03462862|Other|PEEK|PEEK has been successfully used over the last years in the medical ﬁeld, and orthopedics, speciﬁcally. which presents high bio compatibility, good mechanical properties, high temperature resistance, and chemical stability due to a 4 GPa modulus of elasticity, it is as elastic as bone and can reduce stresses transferred to the abutment teeth.Additional advantages of this polymer material are elimination of allergic reactions and metallic taste, high polishing qualities, low plaque afﬁnity, and good wear resistance, it has only recently been used in dentistry.
15924497|NCT03462862|Other|Bre-Flex|"In the recent time thermoplastic materials become quite popular in clinical practice such as nylon and acetal resins. since the 1950, poly-amide resin (nylons) provide improved esthetics and reduction of rotational forces on the abutment teeth due to their low elastic modulus(3).
~The major disadvantage of a nylon removable denture is the inability for a reline procedure and the lack of occlusal rests as well as rigid frameworks, that could lead to occlusal instability and sinking, especially in Kennedy class I and II cases. On the other hand, acetal resins present adequate mechanical strength to form a frame-work more rigid than nylon with retentive clasps, connectors, and supportive elements; however, the acetal resin material lacks natural translucency and vitality."
15924498|NCT03462849|Other|increase in positive end expiratory pressure|increase in positive end expiratory pressure from 5 to 10 then 15 cmH2O then at the value for trans pulmonary end expiratory pressure amounting to 3 cmH2O
15924499|NCT03462836|Drug|IV ketamine/lidocaine/IV PCA apply|In the MA group, 1.0 mg / kg of ketamine is diluted to a total volume of 10 ml. Slowly apply for 1 minute during surgical drape. 1 mg / kg of Lidocaine is loaded at the beginning of surgery. Lidocaine 1.5 mg / kg / hr is administered until the end of the operation.
15924500|NCT03462836|Drug|IV PCA only apply|IV PCA (fentanyl 10mcg/kg + nefopam (Acupan®) 80mg + Ramosetron (Nasea®) ) apply 30min before end of surgery.
15924501|NCT03462823|Device|Osteoconductive scaffold-hamstring tendon composite repair|The device under study is a composite bone substitute composed of a natural mineral matrix of bovine origin, reinforced with biodegradable synthetic polymers and natural collagen derivatives of bovine origin (smartbone, IBI S.A., Switzerland).
15924502|NCT03462823|Device|Hamstring tendon-only repair|ACL-reconstruction using hamstring autograft with hybrid fixation in accordance with in-house standard of care.
15924503|NCT03462810|Drug|cabotegravir, CAB|open label investigational product
15924504|NCT03462784|Other|Demographic, physical examination, data will becollected .|"Demographic data collected includ clinical diagnosis, sex, race, genotype, and phenotype.
~Historical data included information regarding immunizations, infection exposures, surgical procedures, organ dysfunction(Organ dysfunction was defined as a history of requiring medical treatment for heart disease, diabetes (Type 1 or 2), hypoparathyroidism, hypothyroidism, growth hormone deficiency, or gonadal failure) age at transfusion initiation, chelation therapy, type of RBC product, transfusion reactions, and antigen matching. Data will be collected from chart review, patient interviews, blood banking records, and laboratory"
15924505|NCT03462771|Drug|Fish oil|4g of fish oil daily for 14 weeks
15924506|NCT03462771|Drug|sunflower oil|4g of sunflower oil daily for 14 weeks
15924507|NCT03462758|Device|IUD|Postpartum IUD placement
15924508|NCT03462745|Device|AccuVein AV 300|Assess the effectiveness of the AccuVein AV300 device over the standard technique in increasing the ﬁrst-time success rate (SR) for pediatric patients who needed IV cannulation
15924509|NCT03462732|Device|Endotracheal tube|Nasotracheal intubation will be done with endotracheal tube
15924510|NCT03462732|Device|Nelaton catheter|plus nelaton catheter
15924516|NCT03462706|Procedure|Cold Snare|Subjects randomized to Cold Snare Intervention will have any polyps sized 6mm to 15mm removed using cold snare techniques (no electrocautery, no submucosal injection.)
15924517|NCT03462706|Procedure|Hot Snare|Subjects randomized to Hot Snare Intervention will have any polyps sized 6mm to 15mm removed using hot snare techniques (with electrocautery, no submucosal injection.)
15924518|NCT03462706|Procedure|Cold EMR|Subjects randomized to Cold EMR will have any polyps sized 6mm to 15mm removed using cold EMR techniques (no electrocautery, with submucosal injection.)
15924519|NCT03462706|Procedure|Hot EMR|Subjects randomized to Hot EMR will have any polyps sized 6mm to 15mm removed using hot EMR techniques (with electrocautery, with submucosal injection.)
15924520|NCT03462693|Other|Dry needling|The DNHS® dry-puncture technology is specifically marked for stroke patients. the muscle to be treated is placed in a submaximal position; the needle is inserted into the present tense bandage and mobilized in the inside and outside for about 1 minute or until the reaction of global spasm ceases
15924521|NCT03462680|Dietary Supplement|niacin|Niacin or nicotinic acid 250 mg tablets
15924522|NCT03462680|Other|placebo|placebo tablet
15924523|NCT03462667|Behavioral|Stoma Boot Camp|Educational session designed to prepare people for living life with a stoma.
15924524|NCT03462667|Other|Standard of Care|Patients receive normal pre-surgery standard of care.
15924553|NCT03462446|Drug|Vitamin K antagonists (VKAs)|As prescribed by treating physicians. VKAs are Acenocoumarol and Warfarin.
15924554|NCT03462420|Other|Physical Therapy program|The physical therapy program will be chosen by the treating therapist. However, the most common physiotherapy interventions include therapeutic exercises, joint mobilization techniques and electrotherapy.
15925975|NCT03450616|Procedure|Compression Dressing|Standard of Care Compression Dressing
15924525|NCT03462654|Behavioral|iLiFE|In the individual LiFE (iLiFE), the program is taught in seven visits in the individuals' homes within eleven weeks. Participants are supervised in a face to face situation by one qualified trainer (physiotherapist or sports scientist). Each home visit takes between 1 and 1.5 hours. A total of five balance exercises, seven strength exercises for the lower extremities, and two exercises to increase physical activity are taught. In addition to the home visits, all participants receive two 'booster telephone calls' within the remaining weeks until the 6-month follow-up assessments.
15924526|NCT03462654|Behavioral|gLiFE|The group-based LiFE (gLiFE) program consists of seven group sessions (n = 8-12 participants) which are held over the course of eleven weeks, with a maximum duration of 2 hours per session. Each session is led by two qualified trainers (physio therapists or sports scientists), i.e., one main and one co-trainer. In all group sessions, trainers will teach the participants how to perform and integrate the LiFE program, i.e., LiFE balance and strength activities into their daily routines. After the group sessions have ended, participants will receive two 'booster telephone calls' within the remaining weeks until the 6-month follow-up assessments.
15924527|NCT03462641|Drug|Flumazenil|1mg in 10cc normal saline
15924528|NCT03462641|Drug|Placebo|10 cc normal saline
15924529|NCT03462628|Procedure|PVI|CPVI plus low-voltage substrate modification in the left atrium during SR and CPVI alone
15924530|NCT03462615|Diagnostic Test|HS-RDT|A single finger-prick blood sample will be collected and used to test participants with the HS-RDT. The results of the results of the test will not be used for treatment purposes nor used to inform patient care.
15924531|NCT03462602|Procedure|NGT group|After induction of anesthesia, a 14- or 16-Fr single-lumen NGT was placed in all patients. Its intragastric position was confirmed by intraoperative palpation. Randomization to the NGT or non-NGT group was performed on completion of surgery by computer-generated randomization provided by the supervision department.The NGT was retained until the return of bowel function (passage of flatus or passage of stool) in the patients assigned to the NGT group.
15924532|NCT03462602|Procedure|non-NGT group|After induction of anesthesia, a 14- or 16-Fr single-lumen NGT was placed in all patients. Its intragastric position was confirmed by intraoperative palpation. Randomization to the NGT or non-NGT group was performed on completion of surgery by computer-generated randomization provided by the supervision department.The NGT was removed in the operation room immediately after the surgery in those assigned to the non-NGT group.
15924533|NCT03462589|Drug|SY-008|The study will be initiated in healthy subjects at a 2-mg dose that is expected to have minimal pharmacologic effect. Doses will be escalated in subsequent dosing process, after appropriate review of safety data. The subsequent planned doses are 6, 12, 18, 24, 30mg successively. The increment of the dose escalation may be reduced, a lower dose may be administered following data review.
15924534|NCT03462576|Combination Product|Methacetin Breath Test|A breath analyzer will be used to measure changes in carbon 12 to carbon13 ratio as a result of metabolism of the Methacetin substrate before and after treatment.
15924535|NCT03462576|Drug|Emricasan|Investigational drug for NASH treatment in Main Conatus protocol
15924536|NCT03462576|Drug|Placebo oral capsule|Placebo versus emricasan in Conatus NASH treatment trial
15924537|NCT03462563|Device|INTERCEED™|when the definite decision to create a temporary ostomy is made, patients will be randomized in 1:1 ratio to either the treatment arm (INTERCEED™) or the control arm (standard of care treatment: no adhesion barrier, no placebo). In subjects assigned to the treatment arm, the INTERCEED™ must be applied beneath the target incision site (the midline incision mainly for the removal specimen)
15924538|NCT03462563|Device|Placebo|During the Phase 1 operation, when the definite decision to create a temporary ostomy is made, patients will be randomized in 1:1 ratio to either the treatment arm (INTERCEED™) or the control arm (standard of care treatment: no adhesion barrier, no placebo).
15924539|NCT03462550|Device|Laryngeal mask|LMA insertion
15924540|NCT03462537|Device|Low level laser therapy|Low level laser therapy protocol - The low level laser therapy protocol was performed in dorsal decubitus, with the head elevated at 45º. The electrodes were placed in line, in the abdominal region. The low level laser therapy device has a length of about 940nm, using 8 pads, which have 64 diodes, each one with 100mW. The duration of the application was established in 8 minutes.
15924541|NCT03462537|Device|Aerobic Exercise|Aerobic exercise protocol - 50 minutes of aerobic moderate-intensity exercise (45-55% of reserve heart rate) using Karvonen´s formula, performed on a cycloergometer. The duration of the exercise was divided into three parts: warm-up (from 0 to 5 minutes); body (from 5 to 45 minutes); and cooling (from 45 to 50 minutes). The entire protocol was monitored through the Polar® brand cardiofrequency and watch.
15924542|NCT03462537|Device|Low level laser therapy without power|Low level laser therapy protocol - The low level laser therapy protocol was performed in dorsal decubitus, with the head elevated at 45º. The electrodes were placed in line, in the abdominal region. The low level laser therapy device has a length of about 940nm, using 8 pads, which have 64 diodes, each one with 100mW. The duration of the application was established in 8 minutes. In this group low level laser therapy device was switched off.
15924543|NCT03462524|Procedure|Esophagectomy|FEV1, FVC and DLCO will be assessed at baseline and one month post induction therapy. Radiation induced lung injury (RILI EORTC grade≥2), CCI, Clavien-Dindo, and pulmonary complications will be monitored. Changes in pulmonary function will be compared with cardiorespiratory symptoms and HR-QL among disease-free survivors.
15924544|NCT03462511|Behavioral|HABIT Intervention|In addition to standard care and education handouts, dyads randomized to the intervention group will receive the HABIT intervention, which includes CHW support and tailored text messages.
15924545|NCT03462498|Drug|1-months DAPT|1-month DAPT followed by 59-month monotherapy
15924546|NCT03462498|Drug|12-month DAPT|12-month DAPT followed by 48-month monotherapy
15924547|NCT03462485|Other|Golf|Eight weeks of twice-daily golf training
15924548|NCT03462472|Behavioral|Lower leg heating|Immersion of lower legs in a circulating water bath at a temperature of 42 degrees Celsius
15924549|NCT03462472|Behavioral|Lower leg transcutaneous electrical nerve stimulation (TENS)|Bilateral lower leg transcutaneous electrical nerve stimulation (TENS) using burst mode at a 3Hz burst rate, 100Hz frequency, and 250 µs pulse duration, sufficient to evoke skeletal muscle contraction
15924550|NCT03462459|Drug|Vancomycin|Vancomycin capsule, 125 mg
15924551|NCT03462459|Drug|Placebo|Capsule containing inert (nonactive) material to mimic 125 mg vancomycin capsule
15924555|NCT03462407|Behavioral|DAID|"The DAID intervention group will engage in imitation based dog training, using positive reinforcement training (operant conditioning) to teach their dog to copy the physical actions they demonstrate on the command Do it."
15924556|NCT03462407|Behavioral|Dog walking|Children will participate in dog walking. Trained assistants will teach the children to teach their dog basic commands. Dog walking will occur during the intervention phase and children will be encourage to walk their dogs at home.
15924557|NCT03462394|Other|Current Script|This is the version of the phone call script currently used at NYU Langone Health.
15924558|NCT03462394|Other|Alternate Script Iterations|Intervention includes various iterations of the phone call script (different wording or script structure).
15924559|NCT03462381|Dietary Supplement|Protein|Three endurance training sessions weekly with protein supplementation post-exercise and before sleep.
15924560|NCT03462368|Procedure|Control|In the procedure of subepithelial connective tissue graft, exposed dental roots will be treated by scaling and root planing only.
15924561|NCT03462368|Procedure|antimicrobial photodynamic therapy|In the procedure of subepithelial connective tissue graft, exposed dental roots will be treated by antimicrobial photodynamic therapy with toluidine blue O (10mg/ml)
15924562|NCT03462368|Procedure|Photobiomodulation|After the procedure of subepithelial connective tissue graft the whole surgical site will receive red laser application.
15924563|NCT03462342|Drug|Olaparib Pill|"For Cohorts A, B, and C: 300 mg twice daily by mouth which is taken continuously for 28 days, which is one cycle.
~Cohort D 1-2: prescribed lower dose of olaparib (100-200mg daily for a 28-day cycle). Three to five dosing schedules will be evaluated. Dose Levels 1-3: olaparib 100 mg twice daily, Days 1-28. For Dose Levels 4-5: 100-200 mg twice daily, Days 1-28. Other dose levels may be considered and will not exceed AZD6738 160mg twice daily by mouth and olaparib 150mg twice daily by mouth."
15924564|NCT03462342|Drug|AZD6738|"For Cohorts A, B, and C: 160 mg orally once daily for first 7 days of every cycle (Days 1-7 of each 28-day cycle).
~Cohort D 1-2: Prescribed higher dose of AZD6738 (120-320 mg daily for about 14 days). Three to five dosing schedules will be evaluated.
~Dose Levels 1-3: 120-160 mg twice daily, Days 1-14, in combination with olaparib twice daily, Days 1-28. Alternatively, AZD6738 at 160 mg once daily Days 1-14 with olaparib at 100-150 mg Days 1-28 may be evaluated.
~Dose Levels 4-5: Alternative dosing schedule of AZD6738 at 80-160 mg once or twice daily, weekly intermittent schedule (Days 1-5, 8-12, 15-19) in combination with olaparib 100-200 mg twice daily, Days 1-28 may be evaluated. AZD6738 at 160 mg twice daily, Days 1-7 or 240 mg once daily Days 1-14 with olaparib 100-200 mg twice daily Days 1-28 may be evaluated.
~Other dose levels may be considered and will not exceed AZD6738 160mg twice daily by mouth and olaparib 150mg twice daily by mouth."
15924565|NCT03462329|Drug|Antibiotics (preferentially oral doxycycline 100 mg bid)|Patients will be treated with antibiotics for Lyme disease.
15924566|NCT03462316|Biological|NY-ESO-1（TCR Affinity Enhancing Specific T cell Therapy）|NY-ESO-1（TCR Affinity Enhancing Specific T cell Therapy）
15924567|NCT03462303|Combination Product|Sham tDCS and tyrosine depleted drink|Transcranial direct current stimulation (sham) of the dlPFC in combination with a tyrosine and phenylalanine free product.
15924568|NCT03462303|Combination Product|Anodal tDCS and tyrosine depleted drink|Transcranial direct current stimulation (anodal) of the dlPFC in combination with a tyrosine and phenylalanine free product.
15924569|NCT03462303|Combination Product|Sham tDCS and balanced drink|Transcranial direct current stimulation (sham) of the dlPFC in combination with a drink containing both tyrosine and phenylalanine.
15924570|NCT03462303|Combination Product|Anodal tDCS and balanced drink|Transcranial direct current stimulation (anodal) of the dlPFC in combination with a drink containing both tyrosine and phenylalanine.
15924571|NCT03462290|Drug|botulinum toxin type A|Botulinum toxin type A, powder for solution, 25 international units (IU), injected towards the sphenopalatine ganglion using MultiGuide
15924572|NCT03462290|Drug|placebo|solution without botulinum toxin A, injected towards the sphenopalatine ganglion using MultiGuide
15924573|NCT03462264|Device|Scoliogold App|The mobile application will include a list of the specific exercises that the patient has to complete on a daily basis. It will have a start/stop button which the patient presses at the beginning and the end of each time that they complete their home exercise programme. This will get logged on to their application which can be accessed by the researcher to monitor home exercise compliance.
15924574|NCT03462264|Other|Pre-Formatted Diary|The pre-formatted diary will prompt the date, start time, end time and a list exercises that the patient has completed that day that the patient will be requested to fill out.
15924575|NCT03462251|Combination Product|Ribociclib and aromatase inhibitor or fulvestrant|Combination of ribociclib and aromatase inhibitor or fulvestrant
15924576|NCT03462251|Combination Product|Capecitabine + bevacizumab OR Paclitaxel +/- bevacizumab|Capecitabine with bevacizumab OR Paclitaxel with or without bevacizumab
15924577|NCT03462238|Procedure|Blood collection for Ppi assay|A 4.5 ml blood sample will be taken with a citrate vacuum tube.
15924578|NCT03462238|Radiation|CT Scan|A scanner will be performed
15924579|NCT03462212|Drug|Carboplatin|chemotherapy medication
15924580|NCT03462212|Drug|Paclitaxel|chemotherapy medication
15924581|NCT03462212|Drug|Bevacizumab|Angiogenesis inhibitor
15924582|NCT03462212|Drug|Rucaparib|PARP inhibitor
15924583|NCT03462199|Dietary Supplement|Actazin (green kiwi powder) High Dose|Participants will consume 4 capsules (600 mg green kiwi powder) daily for 28-days
15924584|NCT03462199|Dietary Supplement|Actazin (green kiwi powder) Low Dose|Participants will consume 4 capsules (150 mg green kiwi powder) daily for 28-days
15924585|NCT03462199|Dietary Supplement|Control Formula (Actazin green kiwi powder + PreticX prebiotic)|Participants will consume 4 capsules (150 mg green kiwi powder + 250 mg PreticX prebiotic) daily for 28-days
15924586|NCT03462199|Dietary Supplement|Livaux (gold kiwi powder) High Dose|Participants will consume 4 capsules (600 mg gold kiwi powder) daily for 28-days
15924587|NCT03462199|Dietary Supplement|Livaux (gold kiwi powder) Low Dose|Participants will consume 4 capsules (150 mg gold kiwi powder) daily for 28-days
15924588|NCT03462199|Dietary Supplement|Placebo (microcrystalline cellulose)|Participants will consume 4 capsules containing no active ingredients daily for 28-days
15924589|NCT03462186|Other|Healthfinder invitation|Invitation to use healthfinder (healthfinder.gov/myhealthfinder
15924590|NCT03462173|Drug|yimitasvir|Capsule administered orally once daily
15924592|NCT03462160|Other|Placebo control group|Placebo will be administered orally, after dissolving the sachet in lukewarm water, every evening during the meal. The placebo appearance will be similar to the probiotic.
15924593|NCT03462160|Dietary Supplement|Probiotic experimental group|Probiotic UroLact containing Lactobacillus rhamnosus PL1 and Lactobacillus plantarum PM1 will be administered orally, after dissolving the sachet in lukewarm water, every evening during the meal.
15924594|NCT03462147|Device|Spinal cord stimulation|Spinal cord stimulation will be given according to the arms of the group (no stimulation, high density stimulation of conventional stimulation)
15924595|NCT03462134|Other|Survey|Survey amongst orthopaedic surgeons
15924596|NCT03462121|Drug|RPh201|RPh201 is a well-defined extract from a botanical source
15924597|NCT03462121|Other|Placebo|Inactive placebo consisting of the therapeutic vehicle
15924598|NCT03462108|Biological|Rotavirus (Bio Farma) Vaccine|Rotavirus (Bio Farma) Vaccine
15924599|NCT03462108|Other|Placebo|Placebo contains 30% sucrose in DMEM
15924600|NCT03462095|Procedure|Autologous HSCT|After the 3rd consolidation, T-cell ALL patients, randomized to auto-HSCT will be mobilised by G-SCF and harvested disregarding MRD-status. After completing the 5th consolidation T-ALL patients will be transplanted after non-myeloablative CEAM (CCNU, Ethoposide, ARA-C, Melphalan) conditioning, and after reconstitution will continue 2-years maintenance
15924601|NCT03462082|Other|Asymmetric STN-DBS|Asymmetric deep brain stimulation
15924602|NCT03462069|Drug|Sotagliflozin (SAR439954)|"Pharmaceutical form: tablet
~Route of administration: oral"
15924603|NCT03462069|Drug|Placebo|"Pharmaceutical form: tablet
~Route of administration: oral"
15924604|NCT03462069|Drug|Empagliflozin|"Pharmaceutical form: capsule
~Route of administration: oral"
15924605|NCT03462069|Drug|Placebo|"Pharmaceutical form: capsule
~Route of administration: oral"
15924606|NCT03462056|Dietary Supplement|Cystic Fibrosis Ready to Use Supplemental Food|Specially formulated for use by children with Cystic Fibrosis
15924607|NCT03462043|Combination Product|ND0612|s.c. infused
15924608|NCT03462043|Combination Product|CLES|Carbidopa-Levodopa Enteral Suspension.
15924609|NCT03462030|Drug|Baked non-fat cow's milk powder|Oral immunotherapy with increasing quantities of baked milk.
15924610|NCT03462030|Drug|Placebo: Tapioca Powder|Placebo control.
15924611|NCT03462017|Drug|SAR247799|Pharmaceutical form:Capsule Route of administration: Oral
15924612|NCT03462017|Drug|Placebo|Pharmaceutical form:Capsule Route of administration: Oral
15924613|NCT03462017|Drug|Sildenafil|Pharmaceutical form:Encapsulated tablet Route of administration: Oral
15924614|NCT03462017|Drug|Acetylcholine|Pharmaceutical form:Solution Route of administration: Transdermal
15924615|NCT03462004|Biological|HPIV3/ΔHNF/EbovZ GP vaccine|Administered intranasally
15924616|NCT03462004|Biological|Placebo|Administered intranasally
15924617|NCT03461991|Device|Ultrahigh resolution Spectral Domain OCT|A spectrometer based ultrahigh resolution Spectral Domain OCT (SDOCT) system operating at 800 nm for the anterior chamber will be employed in the present study. The spectrum of the Ti:Sapphire laser light source is centered at 800 nm. With a full width at half maximum bandwidth of 170 nm, the axial resolution is 1.3 μm in the cornea. The transverse resolution of the employed OCT system is 21 μm at the front surface of the cornea. For measurement, patients will place their head in a modified slit lamp head rest. During the measurement period, patients will be asked to look straight forward onto an internal fixation target and to avoid blinking. Different scattering patterns, e.g. raster, circular and spiral scans will be employed.
15924618|NCT03461978|Device|Ultrahigh resolution Spectral Domain OCT|A spectrometer based ultrahigh resolution Spectral Domain OCT (SDOCT) system operating at 800 nm for the anterior chamber will be employed in the present study. The spectrum of the Ti:Sapphire laser light source is centered at 800 nm. With a full width at half maximum bandwidth of 170 nm, the axial resolution is 1.3 μm in the cornea. The transverse resolution of the employed OCT system is 21 μm at the front surface of the cornea. For measurement, patients will place their head in a modified slit lamp head rest. During the measurement period, patients will be asked to look straight forward onto an internal fixation target and to avoid blinking. Different scattering patterns, e.g. raster, circular and spiral scans will be employed.
15924619|NCT03461965|Behavioral|3D printed model|A printed 3D model of MMS will be created showing a model of skin, and a tumor to visually depict the surgery
15924620|NCT03461965|Behavioral|Verbal Counselling|Participants will be educated with a standardized script on skin cancer, risks for skin cancer, treatment options, and MMS
15924621|NCT03461952|Drug|Nivolumab|240mg
15924622|NCT03461952|Drug|Ipilimumab|1mg/kg
15924623|NCT03461939|Other|ePRIME symptom monitoring tool|ePRIME is an online system for patients to self-report symptoms and AE during cancer treatment. ePRIME allows AE reporting from home or hospital and enables patient reported data to be integrated into existing EPR to allow for the reports to be used in routine care. In addition the system is capable of generating notifications for severe AE to the relevant clinical team and providing patient advice on managing mild and moderate AE.
15924624|NCT03461926|Behavioral|(SB-related planning + daily text messages)|Participants will receive a one-on-one behavioral counseling session, and planning sheet as reference for developing strategies as part of their Action/Coping Plan. Participants will be asked to form 3-4 actions/coping plans specifying when, where, how, and for how long they would reduce workplace sitting time; and anticipate potential barriers and identify ways they could be overcome. Strategies will focus on increasing break frequency to every 30-45 minutes, achieving a break duration of 2-3 minutes, and increasing standing and light-intensity PA time, during work hours. Participants will receive sedentary behaviour-related text messages twice daily, depending on their preferences and schedule, which will act as mini-booster interventions.
15924625|NCT03461913|Procedure|Cesarean section|Lower segment elective Cesarean section
15924647|NCT03461731|Device|905 nm laser|905 nm laser applied to forearm at 4.4 Joules per square cm during 40 hand grips
15924648|NCT03461718|Drug|Ketamine|Experimental arm for sedation.
15924649|NCT03461718|Drug|Midazolam injection|Part of standard sedation regimen and anxiolysis and for minimization of emergence reaction
15924650|NCT03461718|Drug|Fentanyl|Part of standard sedation regimen
15924755|NCT03460873|Procedure|holmium laser enucleation of the prostate|undergo holmium laser enucleation of the prostate
15951748|NCT03250598|Drug|AG-348|50 mg single-dose
15924626|NCT03461900|Other|Minifluid challenge|Pragmatic optimization fluid management protocol based on Mini-Fluid Challenge (MFC) in treating an acute circulatory failure. MFC consist of an infusion of 100 ml of colloid solution (4% human serum albumin) during 1 minute via a separate venous line. Before and after each MFC and depending on the hemodynamic device used, the attending physician will perform a first set of hemodynamic measurements, including cardiac index (CI) or cardiac output (CO); stroke volume (SV), indexed stroke volume (iSV) or velocity time index (VTI). If the variation in measurement is superior to 10%, the attending physician will infuse 400 ml of buffered crystalloid solution or saline solution. After an infusion of 500 ml, fluid responsiveness will be evaluated with CI or CO measurement. For non-responders, fluid challenge must be stopped and other therapeutics should be considered. For responder, another MFC should be consider if hemodynamic status is not stabilized.
15924627|NCT03461900|Other|Usual practice|Patients included in control group will be managed according to the last surviving sepsis recommendations edited in 2017.
15924628|NCT03461887|Behavioral|Exercise|"Home-based exercise training program that requires only minimal equipment, and is individually adaptable to the participant's exercise level (6 times per week; 15-20 min; 38 exercise cards and one interactive training agenda booklet). After randomization, a health care professional (HOMEX coach) will visit the intervention group participants at their home to set up the training location, to instruct the exercises and to establish individualized goals. Follow-up visits are planned after 3 and 8-9 weeks. Regular telephone calls will be conducted by the same HOMEX coach to motivate the patients, to discuss training progress and concrete benefits and barriers, and to adapt goals and the training program. Additional intervention elements are that a relative or friend is involved as a sparring partner to support the participant. The general practitioner is informed about the participation of his/her patient in the intervention."
15924629|NCT03461874|Behavioral|Education of patients|"During withdrawal treatment, patients are given recommendations on the approach to the use of drugs for acute treatment of migraine headache and on lifestyle issues. With regard to drugs, patients will be encouraged to restrict use of acute medications to headaches with severe pain; i.e., those rated as 8 or greater on a 0-10 (no pain - pain as bad as it could be). In these instances, patients will be instructed to take Eletriptan (40 mg) and/or Almotriptan (12.5 mg) as the first-line treatment, indomethacin (50 mg) as the second line, and will be specifically urged to avoid opioids. With regard to healthy lifestyle issues, patients will be encouraged to engage in moderate physical activity (i.e., 45 minutes twice per week of aerobic exercise), remain well hydrated, consume 3 meals per day, and maintain a regular sleep/wake pattern with at least 7-8 hours of sleep per night."
15924630|NCT03461874|Behavioral|ACT|"ACT consists in 6 weekly sessions, 90 minutes each, and 2 supplementary booster sessions, at two and four weeks after the conclusion of the weekly session. The main focus of the six ACT session will be the following: 1) Creative helplessness: the problem of control; 2) Indentifying values: introduction to Mindfulness; 3) Actions guided by values: working with thought; 4) Working with Acceptance and Willingness; 5) Committed Actions: self-as-context; 6) Integration: working with obstacles - wrap-up. The booster session starts with a mindfulness exercise, followed by a review of the contents covered across the ACT program.
~Patients will be trained in small groups (5-7 patients each) and guided by a specifically trained therapist. They will be educated to practice at home according to the instructions given by the therapist during the sessions."
15924631|NCT03461874|Drug|Pharmacological prophylaxis|Pharmacological prophylaxis will be prescribed based on patients' profile (e.g. previous failures or contraindications), and limited to Topiramate, Propanolol, Amytriptiline or Flunarizine. Doses will depend on patients' features, and the doses herein reported are to be intended as approximate ones: Topiramate at the dose of 50mg/day; Propanolol at the dose of 20mg/day; Amytriptiline at the dose of 10mg/day; Flunarizine at the dose of 5mg/day.
15924632|NCT03461861|Drug|AGB101 220 mg|AGB101 oral dose of 220 mg/day capsule, given as once-daily dosing.
15924633|NCT03461861|Other|Placebo|Placebo, oral capsule given once-daily.
15924634|NCT03461848|Other|CYPHP Evelina London Model of care|Universal services offer, Paediatric hotlines, Education and training for health professionals, Online decision support tools and guidelines, Young people-friendly access to primary care, and Resilience training in schools, Targeted services offered dependent on need. Children with any of the tracer conditions will be offered pathway based care including early intervention for physical and related mental health needs, paediatric nursing support, care plans shared with schools, medication reviews, and peer-led parenting support. Self-management support, social support signposting, and safety-netting are offered to all.
15924635|NCT03461848|Other|Enhanced Usual Care|Universal services offer, Paediatric hotlines, Education and training for health professionals, Online decision support tools and guidelines, Young people-friendly access to primary care, and Resilience training in schools, Self-management support, social support signposting, and safety-netting are offered to all.
15924636|NCT03461835|Diagnostic Test|Risk classification of PUL by M4|High or low risk of being an ectopic pregnancy
15924637|NCT03461835|Diagnostic Test|Risk classification of PUL by NICE|High or low risk of being an ectopic pregnancy
15924638|NCT03461809|Other|Ocular acupuncture|Patient's skin located in the extraocular muscles projection area is routinely disinfected. A diameter of 0.20 mm and length of 25 mm needle is inserted slowly. Piercing depth is about 20mm. The electropuncture apparatus is used, each group of electrodes are distinguished with different colors of wires to generate current stimulations of current 1.0~1.5 milliampere (mA), voltage 9 volt(V), frequency 1.5 hertz (Hz), and duration of 40 minutes.
15924639|NCT03461783|Device|Zorflex Activated Carbon Dressing|Antimicrobial dressing
15924640|NCT03461783|Device|Standard of Care|foam, calcium alginate, hydrogel, or compressive dressings
15924641|NCT03461770|Other|CPAP|Patients will receive general anesthesia induction with CPAP at 5 cmH20 via face mask with a circular system. CPAP will use before extubation.The air-test will perform during anesthesia with transitory decreases inspired fraction of oxygen to 0.21 over a 5 min period. Recruitment maneuver will be perform if the air test is positive, ( SpO2 is ≤ 96%)
15924642|NCT03461757|Drug|Rimegepant|75 mg ODT QD
15924643|NCT03461757|Drug|Placebo|Placebo ODT to match rimegepant dose QD
15924644|NCT03461731|Device|Control|laser beam only
15924645|NCT03461731|Device|800 nm laser|800 nm laser applied to forearm at 4.4 Joules per square cm during 40 hand grips
15924646|NCT03461731|Device|combination laser|800 nm and 905 nm laser applied to forearm at 4.4 Joules per square cm during 40 hand grips
15951749|NCT03250598|Drug|AG-348|5 mg single-dose
15924651|NCT03461705|Device|Volcano Verrata Pressure Wire|"Steerable guidewire with a pressure transducer mounted 3cm proximal to the tip. The guidewire has a diameter of 0.014.
~and is packaged preconnected to the connector with a torque device to facilitate navigation through the vasculature."
15924652|NCT03461705|Device|St. Jude Medical (SJM) Aeris Pressure Wire System|The pressure wire is a 0.014'' guidewire with a pressure and temperature sensor integrated into the tip to enable measurements of physiological parameters.
15924653|NCT03461692|Drug|patients under 14 years of age using Reduning injeciton|To assess in patients using Reduning injection's clinical features and drug adverse reaction during patients' hospital stay. The registry procedure will only for patients under 14 years of age using Reduning injection,observed from February 2018 to December 2018.
15924654|NCT03461679|Procedure|Adductor canal block|Single shot block with 0.5% bupivacaine 10mls
15924655|NCT03461679|Procedure|Femoral triangle block|Single shot block with 0.5% bupivacaine 10mls
15924656|NCT03461666|Behavioral|Cognitive Behavior Therapy-Insomnia|Behavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each.
15924657|NCT03461666|Behavioral|Focus of Attention|Behavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each.
15924658|NCT03461666|Behavioral|Combined-CBT-I and FOA Group|Behavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each.
15924659|NCT03461666|Behavioral|Sleep Hygiene|Behavioral Psycho-intervention education therapy.Face to Face, Six sessions, one hour each.
15924660|NCT03461653|Other|Telemedicine counselling|women on web counselling
15924661|NCT03461640|Other|Community-based doula support for labour|CBDs will be recruited, trained and employed by non-profit organization MIRA. Women allocated to receive CBD support will be contacted by an either a Somali, Arabic-, Russian- or Tigrinya-speaking CBD as appropriate, and arrangements made for them to meet twice prior to the birth to get to know each other and discuss the woman's wishes regarding support in labour and what the CBD can offer. Each woman will then contact her CBD when she goes into labour and the CBD will attend hospital with her and stay with her throughout her labour and birth, in addition to any other support people she may have, such as her partner.
15924662|NCT03461640|Behavioral|Standard labour support|"Standard labour support by health care providers only. Women allocated to the comparison arm of the trial will receive standard intrapartum care as provided at their chosen hospital of birth. That is emotional, information and instrumental support from a helping nurse or a midwife or in some cases a doctor. The support includes caring actions, such as comforting, massage, information and presence.
~Note: Women partner and/or other support people to accompany throughout her childbirth will be allowed, regardless of their trial allocation."
15924663|NCT03461627|Drug|Salmeterol Xinafoate and Fluticasone Propinate Powder|50ug/250ug 1 puff twice a day for 4 weeks
15924664|NCT03461627|Drug|Seretide|50ug/250ug 1 puff twice a day for 4 weeks
15924665|NCT03461614|Other|Exercise group|Exercise group mainly conducted the 5 core stabilization exercises as described by McGill. These include the curl-up, side bridge, trunk extension, double leg lifts and bird-dog exercises that support respiratory functions. In other words, every single training session consisted of frontal, dorsal, and lateral core exercise. In general, participants always exercised in group so that for integration and motivation. During training weeks 1-2, participants exercises with 3 sets per exercise and 10 s contraction time and 10 repetitions. During training weeks 3-4, contraction times and repetitions were increased to 15 s and 15 repetitions. Additionally, increasing the complexity of exercises, adding opposite limb movements and increasing the lever arm of the exercises were done.
15924666|NCT03461614|Other|Control group|In addition to the service routine rehabilitation program mentioned above, participants in the Control group participated in leisure activities such as table tennis/basketball under service staff supervision for 45-60 minutes, 2 times a week, 6 weeks similar time period of Exercise group.
15924667|NCT03461601|Procedure|HCG Uterine flushing|HCG Uterine flushing was done one day before IUI with HCG (500 IU) in 10 ml of saline.
15924668|NCT03461601|Procedure|IUI|Intrauterine insemination (IUI)
15924669|NCT03461601|Procedure|Vaginal flushing with 10 ml normal saline|Flushing of the vagina with 10 ml of saline
15924670|NCT03461588|Radiation|free-breathing|patients are irradiated to whole breast +- regional nodal areas with free-breathing technique after breast conserving surgery
15924671|NCT03461588|Radiation|deep inspiratory breath-holding|patients are irradiated to whole breast +- regional nodal areas with deep inspiratory breast-holding technique after breast conserving surgery
15924672|NCT03461575|Drug|HU007|cyclosporine 0.02%, trehalose 3%
15924673|NCT03461575|Drug|Restasis|cyclosporine 0.05%
15924674|NCT03461575|Drug|Moisview|trehalose 3%
15924675|NCT03461562|Other|Aerobic Exercise|Aerobic exercise wil be held for 40 minutes. Dynamic exercises will be accompanied by physiotherapist on the vibration platform for 15 minutes. Same excercises will be held stable platform (when the devices turned off) by control group for 15 minutes.
15924676|NCT03461549|Device|Pressure and Temperature Sensor|This device includes pressure and temperature sensor embedded within silicone and applied to the skin with a medical grade adhesive.
15924677|NCT03461536|Behavioral|Ultrasound-first Clinical Decision Support tool|"Intervention: The intervention is the CDS tool, which consists of 4 components:
~Four questions which assess the appropriateness of ultrasound for this patient
~A link to the evidence
~Buttons to remove CT scan and order ultrasound
~If the CT scan order is kept, reasons why ultrasonography is not appropriate The CDS tool will be placed or integrated into EPIC, at the point of order entry. The tool will be triggered by an order for CT scan for kidney stone.
~Appropriateness criteria for ultrasound:
~Adults aged >18 and < 76
~Non-obese (men < 285lbs, women < 250lbs)
~Low risk of Stone Emergency (Obstructing stone and any of the following: urosepsis, renal deterioration, post kidney transplant, solitary kidney, intractable symptoms)
~Low risk of clinically significant alternative diagnosis (e.g. appendicitis, cholecystitis, AAA, ovarian torsion) If all responses are affirmative, then the subject should receive US, and US order is provided."
15924678|NCT03461510|Procedure|Hyperglycemic clamp|Subjects with T2D will receive IV Dextrose infusion to maintain plasma glucose at ~250 mg/dL during fMRI.
15924679|NCT03461510|Procedure|Hyperinsulinemic Euglycemic clamp|Subjects with T2D will receive IV Dextrose and Insulin infusion to maintain plasma glucose at approximately 90 mg/dL during fMRI.
15924680|NCT03461471|Behavioral|Exercise Intervention|Exercise intervention
15951750|NCT03250598|Drug|AG-348|200 mg single-dose
15924681|NCT03461458|Drug|Autologous Adipose-Derived Mesenchymal Stromal Cells|Human, autologous, culture expanded, adipose-derived, mesenchymal stromal cells (AMSCs) produced on site in the Mayo Clinic Immune Progenitor and Cell Therapeutics Laboratory using current good manufacturing practices (cGMPs).
15924682|NCT03461445|Drug|Envarsus|Patients will be randomized to receiving Envarsus instead of IR Tacrolimus
15924683|NCT03461445|Drug|IR Tacrolimus|Patients will be randomized to receiving IR Tacrolimus instead of Envarsus
15924684|NCT03461432|Behavioral|Cognitive Remediation Therapy|Cognitive Remediation Therapy (CRT) is a psychological therapy that has been developed with a general immediate focus on improving impaired cognitive domains but ultimately aimed at improving social and functional outcomes.
15924685|NCT03461419|Procedure|Microcannula Harvest Adipose Stroma|Use of Disposable, Closed Syringe Microcannula Harvest Autologous Adipose Stroma and Stem/Stromal Cells
15924686|NCT03461419|Device|Centricyte 1000|Centricyte 1000 closed system digestion of stromal vascular fraction to isolate and concentrate stem/stromal cells associated with microvasculature
15924687|NCT03461419|Procedure|Sterile Normal Saline IV Deployment of cSVF|Sterile Normal Saline Suspension cSVF in 500 cc for Intravenous Delivery Including 150 micron in-line filtration
15924690|NCT03461393|Device|Medical-Eye-Trainer (MET)|In order to provide a high contrast, dynamic visual stimulus to the patients, we developed an app that allowed the patients to regularly train with this stimulus. The app runs on Android (version 4.2 or later). The display of the screen is divided into 4 rows. In each row, a pattern of black and white squares is moving in one direction. The directions in subsequent rows are opposite to each other. Through the movement in the opposite direction a changing pattern is achieved in vertical and horizontal extension, the pattern alternates between continuous beams and a checkered pattern. The speed of the display on the monitor is 2 cm per second. In a comfortable viewing distance (ca. 40 cm), this leads to an angular velocity of approximately 3°/sec.
15924691|NCT03461380|Dietary Supplement|Menopause Relief EP-40|Fixed combination of black cohosh and Rhodiola rosea
15924692|NCT03461380|Dietary Supplement|Low Dose Black Cohosh|6.5 mg black cohosh
15924693|NCT03461380|Dietary Supplement|High Dose Black Cohosh|500 mg black cohosh
15924694|NCT03461380|Dietary Supplement|Placebo|600 mg excipient
15924697|NCT03461341|Other|High intensity postoperative oncologic surveillance|High intensity surveillance protocol using routine cross-sectional imaging (computed tomography or positron emission tomography with computed tomography).
15924698|NCT03461328|Drug|Magnesium Sulphate|intra-operative infusion of of 10% MgSO2 , stating by a laoding dose of 30be used, a loading dose of 30 mg/kg over 20 min followed by continuous infusion of 10 mg/kg/hr accomplish the total laryngectomy.
15924699|NCT03461315|Other|Functional assistance model|Preventive home visits carried out by a Team Dedicated Exclusively to the Home Patient.
15924700|NCT03461302|Drug|Topical coal tar|Solution carbonis detergens 10% in cremor vaselini lanette FNA and pix lihantracis 3% in zinc oxide paste
15924701|NCT03461302|Drug|Topical corticosteroids|Clobetasone butyrate 0.05% ointment
15924702|NCT03461289|Biological|Onasemnogene Abeparvovec-xioi|Onasemnogene abeparvovec-xioi is a non-replicating recombinant adeno-associated virus serotype 9 (AAV9) containing the human survival motor neuron (SMN) gene under the control of the cytomegalovirus (CMV) enhancer/chicken β-actin-hybrid promoter (CB).
15924703|NCT03461276|Biological|ABvac40|ABvac40 consists in a conjugate of Aβx-40 with a carrier protein (KLH) vehiculated in phosphate buffer containing 0.35% aluminium hydroxide as adjuvant.
15924704|NCT03461276|Biological|Placebo|Placebo consists in the vaccine's vehicle (phosphate buffer containing 0.35% aluminium hydroxide) without the conjugate.
15924705|NCT03461263|Other|phonophoresis treatment using pumpkin seeds oil|phonophoresis treatment using pumpkin seeds oil
15924706|NCT03461250|Diagnostic Test|HCV serology|Apply CRF to identify risk factors for HCV infection. In patients with positive HCV serology measure the level of viral load and HCV genotype by PCR Abbott-real time and determine the stage of liver fibrosis by elastography (Fibroscan)
15924707|NCT03461224|Radiation|accelerated hypofractionated RT|
15924708|NCT03461224|Radiation|conventional fractionated RT|
15924709|NCT03461211|Biological|Teprotumumab|Teprotumumab is a fully human anti-IGF-1R mAb. Teprotumumab will be provided in single-dose 20 mL glass vials as a freeze-dried powder. Each vial of teprotumumab must be reconstituted with 10 mL of water for injection. Reconstituted teprotumumab solution must be further diluted in 0.9% (w/v) sodium chloride (NaCl) solution prior to administration. Teprotumumab will be administered in 100 mL or 250 mL infusion bags (100 mL infusion bags for doses up to 1800 mg and 250 mL infusion bags for doses > 1800 mg).
15924710|NCT03461198|Device|Restylane® Silk|Restylane® Silk to a defined area of mid to low cheeks
15924711|NCT03461185|Drug|EGFR-TK Inhibitor|EGFR-TKIs include but are not limited erlotinib, gefitinib
15924712|NCT03461185|Drug|Anti-Angiogenic Drugs|Anti-Angiogenic Drugs contain endostatin, apatinib and anlotinib
15924713|NCT03461172|Procedure|Surgery of breast cancer|Surgery of breast cancer
15924714|NCT03461172|Other|Clinical data collection|The collection centralizes the main characteristics of the patients, the tumor and the treatments. Also included are the date of first recurrence, the localization (local, regional or distant) as well as the death or the date of the latest news.
15924715|NCT03461159|Other|Operant conditioning of H-reflexes|Spinal reflex responses will be elicited in a wrist flexor muscle using a peripheral nerve stimulator. During training trials, the size of the participant's response will be shown on a screen and the participant will be asked to decrease the size of the H-reflex response over successive trials. Responses that are below a threshold will be rewarded and those above will not.
15924753|NCT03460886|Device|Contralesional stimulation|anodal stimulation on contralesional leg area of primary motor cortex and supplementary motor area for 30 minutes
15924716|NCT03461159|Other|Operant conditioning of motor evoked potentials|Motor evoked potentials will be elicited in a wrist flexor muscle using transcranial magnetic stimulation. During training trials, the size of the participant's response will be shown on a screen and the participant will be asked to increase the size of the MEP response over successive trials. Responses that are above a threshold will be rewarded and those below will not.
15924717|NCT03461146|Drug|MT-6548|Oral tablet
15924718|NCT03461133|Other|Intervention|The emergency notification system is linked to a paging system to the surgeon in charge and to the Hospital Medical Emergency Team. Depending on individual Multiparameter Early Warning Score communication protocols are activated.
15924719|NCT03461120|Drug|Experimental continuous peripheral nerve blocks|Bupivacaine 0.3% [or ropivacaine 0.5%] infusions for 7 days via femoral and sciatic perineural catheters
15924720|NCT03461120|Drug|Control continuous peripheral nerve blocks|Bupivacaine 0.1% [or ropivacaine 0.2%] infusions for 1 day followed by normal saline for a total of 7 days via femoral and sciatic perineural catheters
15924721|NCT03461107|Other|No intervention|
15924722|NCT03461094|Device|Preload assessment and volume expansion|Fluid therapy perform
15924723|NCT03461081|Drug|telmisartan/amlodipine and atorvastatin|Telmisartan/Amlodipine(40/5 mg) 2 Tab for 10 days Telmisartan/Amlodipine(40/5 mg) 2 Tab with Atorvastatin 40 mg 1 Tab for 4 days Atorvastatin 40 mg 1 Tab for 4 days
15924724|NCT03461068|Dietary Supplement|Ketone monoester|Acute ingestion of (R)-3-hydroxybutyl (R)-3-hydroxybutyrate prior a 2-hour oral glucose tolerance test.
15924725|NCT03461068|Dietary Supplement|Placebo|Acute ingestion of a taste-matched placebo prior a 2-hour oral glucose tolerance test.
15924726|NCT03461055|Other|Lavender|Lavender aromatherapy
15924727|NCT03461055|Other|Water|Water
15924728|NCT03461042|Drug|Ramelteon 8mg|Ramelteon 8mg once daily before bedtime for 12 weeks since informed consent
15924729|NCT03461042|Drug|Placebo|Placebo capsule once daily before bedtime for 12 weeks since informed consent
15924730|NCT03461029|Device|BIS monitor|The investigators placed on the forehead of all patients the sensor BIS quatroTM, that connects with the monitor, and they registered sedation and recorded the values obtained.
15924731|NCT03461016|Behavioral|Exposure Therapy|"Exposure therapy is a form of behavior therapy that is widely used to treat anxiety disorders, including specific phobia. It involves systematic and repeated confrontation with a feared stimulus. It works by (a) implosive therapy, habituation, in which repeated exposure reduces anxiety over time by a process of extinction; (b) disconfirming fearful predictions; and (c) increasing feelings of self-efficacy and mastery. In vivo exposure [is] a type of exposure therapy, generally used for treating individuals with phobias, obsessive compulsive disorder, and other anxiety disorders, in which the client directly experiences anxiety-provoking situations or stimuli in real-world conditions. (VandenBos, 2015)"
15924732|NCT03461003|Other|NICHE method|Based on underlying comorbidities at enrollment, patients will be assigned to either an unrestricted protocol (amlodipine versus lisinopril) or a restricted protocol (losartan versus lisinopril). Two drugs are tested in randomized order. Failure to achieve BP control at maximum doses of the first two drugs will result in augmentation with a diuretic (hydrochlorothiazide). BP control is assessed with 24 hour ambulatory monitoring at the end of each 2 week treatment period. Side effect tolerability is assessed with a questionnaire.
15924733|NCT03461003|Other|Usual care|Physician preference will dictate choice and adjustment of antihypertensive medication, BP measurement modality, interval between visits, and assessment of side effects.
15924734|NCT03461003|Drug|Amlodipine|Calcium-channel blocker; antihypertensive
15924735|NCT03461003|Drug|Lisinopril|Angiotensin-converting-enzyme (ACE) inhibitor; antihypertensive
15924736|NCT03461003|Drug|Hydrochlorothiazide|Thiazide diuretic; antihypertensive
15924737|NCT03461003|Drug|Losartan|Angiotensin II receptor blocker (ARB); antihypertensive
15924738|NCT03460990|Drug|VX-659/TEZ/IVA|Participants received VX-659/TEZ/IVA orally once daily in the morning.
15924739|NCT03460990|Drug|TEZ/IVA|Participants received TEZ/IVA orally once daily in the morning.
15924740|NCT03460990|Drug|IVA|Participants received IVA orally once daily in the evening.
15924741|NCT03460990|Drug|Placebo|Participants received placebo matched TEZ/IVA orally once daily in the morning.
15924742|NCT03460990|Drug|Placebo|Participants received placebo matched to VX-659/TEZ/IVA orally once daily in the morning.
15924743|NCT03460977|Drug|PF-06821497|Oral continuous
15924744|NCT03460964|Device|Adhesive glucose sensor|"Will assess sensor's performance by comparing readings from an adhesive glucose sensor with those from a glucometer.
~pilocarpine 0.1 mL gel, applied to the skin via the glucose sensor to induce sweat"
15924745|NCT03460964|Drug|Pilocarpine|Pilocarpine 0.1 mL gel, applied to the skin via the glucose sensor to induce sweat; will apply a minimum of 2 doses to each participant.
15924746|NCT03460951|Diagnostic Test|cervical MRI|Cervical MRI will be performed in all of the patients and controls on a 3.0-T scanner (Discovery MR750, General Electric (GE) Medical Systems, Milwaukee, WI, USA)
15924747|NCT03460938|Procedure|Remote ischemic preconditioning|RIPC: 3 periods of 5 minutes of ischemia followed by 5 minutes of reperfusion are created by inflating a blood pressure cuff on the upper extremity after induction of anesthesia and prior to surgery.
15924748|NCT03460925|Radiation|SBRT plus chemotherapy|Neoadjuvant stereotactic body radiotherapy (SBRT, 30 Gy in 5 fractions) plus chemotherapy with Folfirinox
15924749|NCT03460912|Device|Bipolar and monopolar probes (SPESS MEDICA S.r.l. Via Buccari 16153 Genova (GE), Italy) administered to all participants.|Bipolar and monopolar probes (SPESS MEDICA S.r.l. Via Buccari 16153 Genova (GE), Italy) administered to all participants.They compared each others(bipolar vs monopolar) via amplitudes and latency values.
15924750|NCT03460899|Other|Euglycaemic Clamp|All 14 subjects will undergo an euglycaemic clamp at Visit 2 with a plasma Glucose target of 5.5 mmol/L +/- 10% (4 timepoints for platelet activity parameter blood sampling)
15924751|NCT03460899|Other|Hyperinsulinaemic/Hypoglycaemic Clamp|All 14 subjects will undergo a hypoglycaemic/hyperinsulinaemic clamp at Visit 3 with 4 timepoints for platelet activity Parameter blood sampling 30 minutes after reaching certain plasma glucose plateaus (5.5 mmol/L; 3.5 mmol/L; 2.5 mmol/L; after recovery again at 5.5 mmol/L)
15924752|NCT03460886|Device|Ipsilesional stimulation|anodal stimulation on Ipsilesional leg area of primary motor cortex and supplementary motor area for 30 minutes
15951793|NCT03250338|Drug|G-CSF|FLAG-Ida regimen
15924756|NCT03460860|Dietary Supplement|Astaxanthin (2mg)+Lycopene (1.8mg)+D-Alpha-Tocopherol (10IU)|The intervention is to be taken once daily, for 12 weeks.
15924757|NCT03460860|Dietary Supplement|Placebo|The intervention is to be taken once daily, for 12 weeks.
15924758|NCT03460847|Drug|Steroids|Patients with active colitis ulcerosa who need steroids because of their disease course. 1mg/kg bodyweight for one week, followed by a tapping periode.
15924759|NCT03460808|Drug|atorvastatin|Atorvastatin was used in combination with acetylcysteine and danazol.
15924760|NCT03460808|Drug|Acetylcysteine|Acetylcysteine was used in combination with atorvastatin and danazol.
15924761|NCT03460808|Drug|Danazol|Danazol was used in combination with atorvastatin and acetylcysteine or as the monotherapy
15924762|NCT03460795|Biological|MSC and Tregs|conventional plus MSC and Tregs or placebo treatment
15924763|NCT03460782|Biological|Ipilimumab|"Each patient receives Ipilimumab in regimen and dose according to the official manufacturer's instructions (IV 1 mg / kg every 6 weeks for maximum of 4 doses).
~Participation of the patient in the program must necessarily be agreed with the current treatment and contain a written agreement with the attending physician.
~This program is not covered by health insurance. For patients in the postoperative period to provide a mandatory conclusion of histology and molecular-genetic for the identified mutations and the type of tumor."
15924764|NCT03460769|Other|Data Management and Monitoring|The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer responsible for the coordination and data management for the Evaluation of a mixed meal test for Diagnosis and characterization of Type 3c diabetes mellitus secondary to pancreatic cancer and chronic pancreatitis (DETECT), which is part of the NIH U01 funded Consortium for the Study of Chronic Pancreatitis, Diabetes, and Pancreatic Cancer (CPDPC).
15924765|NCT03460756|Drug|Ganaxolone|Oral
15924766|NCT03460756|Drug|Placebo|Oral
15924767|NCT03460743|Biological|Study group - quadrivalent recombinant hemagglutinin influenza vaccine|Eligible subjects will be randomized, 1:1, to receive one or two doses of same vaccine. Subjects will be categorized in two age groups: subjects 9 to 17 years will be allocated in Group A and will receive one dose; Subjects 3 to 8 will be allocated to group B and the ACIP/CDC algorithm will be applied to determine should one or two doses will be applied 28 days apart. Vaccinator will be non blind and will not participate in the clinical evaluation.
15924768|NCT03460743|Biological|Control group - quadrivalent inactivated influenza vaccine|Eligible subjects will be randomized, 1:1, to receive one or two doses of same vaccine. Subjects will be categorized in two age groups: subjects 9 to 17 years will be allocated in Group A and will receive one dose; Subjects 3 to 8 will be allocated to group B and the ACIP/CDC algorithm will be applied to determine should one or two doses will be applied 28 days apart. Vaccinator will be non blind and will not participate in the clinical evaluation.
15924769|NCT03460730|Biological|Pneumovax|23-valent pneumococcal polysaccharide vaccine
15924770|NCT03460717|Other|Peripheral Nerve Field Stimulation by Thermal Micro-Cautery|The most painful points over the knee received an intense heat by a metal rod for 0.5 seconds.
15924771|NCT03460704|Drug|Colistimethate sodium|Inhaled colistimethate sodium twice daily
15924772|NCT03460704|Drug|Saline Solution|Inhaled placebo twice daily
15924773|NCT03460691|Procedure|Bariatric surgery|Bariatric surgery will done to the patients who were morbid obesity
15924774|NCT03460678|Drug|Pemetrexed|Vials containing powder for concentrate for solution for infusion equivalent to 500 mg of pemetrexed (as disodium) administered as 500mg/m2 IV over 10 minutes on the first day of each 21-day cycle, until disease progression or unacceptable toxic effects
15924775|NCT03460678|Drug|Erlotinib|Film coated tablets containing 150 mg erlotinib (as erlotinib hydrochloride) administered once daily until disease progression or unacceptable toxic effects
15924776|NCT03460665|Procedure|Arteriography|knee arteriography
15924777|NCT03460652|Drug|KP415 oral capsule|Once-daily oral dose
15924778|NCT03460639|Radiation|Active laser|Three points on the masseter muscle (upper, middle and lower portions) and one point on the anterior temporal on each side of the face will be irradiated with a wavelength of 780 nm, radiant exposure of 134 J/cm2, power of 50 mW and irradiance of 1.675 W/cm2 for 80 seconds per point, resulting in an energy of 4 J per point and total energy of 32 J per volunteer.20,21 Point application will be performed with a conventional tip in contact with the skin (beam spot: 0.04 cm2).
15924779|NCT03460639|Radiation|Sham laser|The same procedures will be performed in the sham group, but the device will be switched off and a recording of the emission sounds will be used to give the volunteer the auditory sensation of laser therapy.
15924780|NCT03460639|Diagnostic Test|Control group|In this group, we will only induce fatigue.
15924781|NCT03460626|Drug|Lavender Oil|The oil used in this study will be lavender oil with a final concentration of 3% using almond oil (90%) as diluent. The oil after dilution and final preparation will be converted to proper clean vial in a fix amount (10 ml) and given to the students.
15924782|NCT03460626|Other|Placebo|an odorless oil without any therapeutic effect
15924783|NCT03460613|Other|FODMAP diet|Patients with a diagnosed FODMAP intolerance (and a control with no FODMAP intolerance) by prior nutrient challenge testing are going on a FODMAP diet. In a first nutritional visit a specialized nutritionist will inform the patients about FODMAP containing foods and illustrate a FODMAP elimination diet. After 3 weeks of elimination diet another visit will take place and a stepwise reintroduction diet is initiated after successful elimination diet.
15924784|NCT03460600|Other|Optical Coherence Tomography (OCT)|Optical Coherence Tomography is a fairly new imaging technique in ophthalmology
15924785|NCT03460587|Device|Telerehabilitation|The Telerehabilitation system will deliver rehabilitation treatment sessions via an in-home internet-connected computer. A major component of the system is the use of games to promote therapeutically relevant movements. The subject will perform daily assigned home-based telerehabilitation games and exercises and 5 minutes of stroke education, all guided by the telerehabilitation system.During some of the sessions, therapists will initiate a videoconference with the subject's telerehabilitation system to discuss progress, issues, and revise treatment plans as needed.
15924786|NCT03460574|Behavioral|INFORMATION|After receiving expectation-disconfirming positive performance feedback, participants receive standardized information that stresses the relevance of this experience. In particular, participants are told that the performance test they worked on is highly relevant for both professional success and personal life satisfaction.
15953134|NCT03240211|Drug|Decitabine|Decitabine 10 mg/m2
15924787|NCT03460574|Behavioral|SALIENCE|After receiving expectation-disconfirming positive performance feedback, partcipants in this condition are instructed to remember how well they performed on the performance test. Using a visual analogue scale, they were asked to specify how they performed relative to the other participants.
15924788|NCT03460574|Behavioral|ATTENTION|Before working on the performance test, participants are instructed to pay attention to the feedback they receive. In particular, they are asked to enter what would be a personally good result for them. It is supposed that this shift of attention increases the salience of the expectation-disconfirming feedback.
15924789|NCT03460574|Behavioral|CONTROL|This group does not receive any further intervention. Instead, participants of this group pass through the standard procedure of the EXPEC paradigm.
15924790|NCT03460561|Procedure|Thoracic epidural block (TEA)|Under complete aseptic precautions and before induction of GA, thoracic epidural catheter was inserted using a 17 gauge, Tuohy epidural needle by a midline approach. T9-T10 interspace was chosen for the injection after skin infiltration by 5 mL of lidocaine 1%. The epidural space was identified by the loss of resistance technique then the catheter was introduced 2 cm into the epidural space, and epidural test dose of 3 mL of lidocaine 2% with 1:200,000 adrenaline was injected to exclude vascular or subarachnoid position.
15924791|NCT03460561|Procedure|Rectus sheath block (RSB)|"Under aseptic technique, the rectus muscle was imaged with the ultrasound probe, A broadband (5-12 MHz) linear array probe of Sonosite ™ 3000 ultrasound (FUJIFILM, Sonosite EDGE II -UAS) in a transverse orientation at or immediately above the level of the umbilicus, with an imaging depth of 4-6 cm.
~Inserting the needle: An 18G Tuohy needle was introduced few millimeters from the probe using an in plane technique in an angle of 45 degrees to the skin. (posterior rectus sheath and fascia transversalis). Under direct vision, the needle tip was advanced to the desired position where 20 mL of (levo-bupivacaine 0.25% Fentanyl 30 μg) were injected causing hydro dissection of the rectus muscle away from the posterior rectus sheath. The technique is repeated on the opposite side."
15924792|NCT03460548|Device|Remogen|instil 1 drop of the product in each eye, 4 times per day
15924793|NCT03460548|Device|Cationorm|instil 1 drop of the product in each eye, 4 times per day
15924794|NCT03460522|Drug|Inotuzumab ozogamicin|Patients will receive standard of care chemotherapy (consolidation and maintenance) after Inotuzumab Ozogamicin.
15924795|NCT03460509|Drug|Sugammadex|Dose-response
15924796|NCT03460496|Behavioral|neonatologists|will continue to be contact persons for the APN, even after hospital discharge, and will be available for 3 fixed outpatient consultations with the APN and families that have difficulty getting to a paediatrician, because they live in a rural area with no paediatrician.
15924797|NCT03460496|Behavioral|psychological support|Psychological support will be standard for all families. In a first consultation, psychologist and family will decide about long-term psychological support. They will have at least 3 follow-up consultations during hospital stay and one before discharge; specific psychological interventions will be provided. The aim of the interventions is to re-establish emotional stability and improve the ability of parents to cope with the situation, to prevent parental and family adaptive disorders and child developmental disorders. Support focus on screening for psychological disorders. Techniques include family-centred, holistic interventions (e.g. activating parental resources and coping, crisis intervention, stabilization techniques etc.). Parents will receive outpatient psychological support.
15924798|NCT03460496|Behavioral|lactation consultant|during hospitalization, the lactation consultant will be involved more frequently than during standard care. Breastfeeding support will take a structured approach and will be performed in close collaboration with both parents. The main aims of structured breastfeeding support are strengthen parent-child bonding. Infants will be breastfed according to their needs. Parents will become competent in meeting their child's nutritional needs. After discharge, parents may schedule outpatient breastfeeding consultations.
15924799|NCT03460496|Behavioral|physiotherapeutic interventions|physiotherapeutic interventions will also be structured. The physiotherapist will make an assessment during hospitalization, and decide which physiotherapeutic interventions are necessary. Each family will learn how to handle their premature child in everyday life, based on the child's developmental stage, in a single consultation.
15924800|NCT03460496|Behavioral|social workers|social workers will closely collaborate with the APN within the transitional model. They will be involved with every family and will assist the APN in establishing a network with social and medical services within and outside the clinic. They will also support families in coping with daily life and with their integration into society, family and work. Furthermore, they will give advice on social security issues and on asserting claims as well as clarify financial possibilities.
15924801|NCT03460496|Behavioral|music therapy|music therapy with premature infants and their parents creates a new dimension of contact, and helps stabilize the child and supports their development through music. It also reduces the anxiety of parents, and enhances self-efficacy and makes them more sensitive to their child 74,75, thus enhancing the parent-child relationship. In standard care, music therapy is offered only during hospitalization. In the new model of care, after NICU discharge, the program will offer 10 follow-up sessions at the family's home or in the music therapists' private practice.
15924802|NCT03460496|Behavioral|other health care professionals|the APN will contact and involve other health care professionals, like the family's paediatrician, the outpatient midwife, the community health care nurse or the mother and father counselling as soon as need becomes evident. The APN will help set up meetings between health care professionals and the family, and will keep them up-to-date on the family's situation.
15924803|NCT03460496|Behavioral|interprofessional roundtable meetings|interprofessional roundtable meetings with health care professionals involved in the care of a specific family will be held every two weeks. The meeting is aimed at developing consensus on the best possible support in the care of preterm infants and their families. Parents will be invited to participate in these meetings, led by the APN. The meeting will focus on two family situations, and then determine and initiate supportive interventions in collaboration with the parents.
15924836|NCT03460158|Drug|Restylane-L® Lyft|Restylane-L® Lyft is for the indication of implantation into the deep dermis to superficial subcutis for the correction of moderate to severe facial folds and wrinkles, such as nasolabial folds and malars (cheek/cheek bone area).
15924837|NCT03460158|Drug|Restylane Silk®|Restylane Silk® is for the indication for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids in patients over the age of 21.
15924804|NCT03460496|Behavioral|Advanced practice nurses' interventions|The APN will participate in comprehensively planning individual discharge, coordinating services, consulting with other healthcare professionals, assessing needs on a case by case basis, and coaching the family from birth to 6 months after discharge from the NICU. The APN will provide the Newborn Behavioral Observation (NBO), an infant-centred and family-focused method for building relationships, to parents and children, during and after hospitalization. The NBO helps sensitize parents to their infant's competencies and capabilities, teaching them to read their infant's signals and understand their behaviours. It promotes positive interactions between parent and preterm infant. The APN will also offer telephone support and follow-up Visits at home after discharge.
15924805|NCT03460483|Other|Genetic Counseling|Undergo genetic counseling
15924806|NCT03460483|Other|Genetic Testing|Undergo genetic testing
15924807|NCT03460483|Other|Laboratory Biomarker Analysis|Correlative studies
15924808|NCT03460483|Procedure|Mutation Carrier Screening|Undergo tumor screening via next-generation sequencing
15924809|NCT03460470|Drug|Sildenafil|PDE5 Inhibitor
15924810|NCT03460470|Drug|Placebo oral capsule|Placebo for Sildenafil
15924811|NCT03460457|Drug|TQB2450|Pharmacokinetics/Dynamics Study
15924812|NCT03460444|Dietary Supplement|MCT Oil Supplementation|Participants consume MCT oil (97-99% octanoic acid) twice per day for 14 days. Dosing will begin at 5ml/dose for Days 1-2, 10ml for Days 3-4, and 15ml for the remainder of the intervention.
15924813|NCT03460431|Device|fractional CO2 laser 10,600nm|fractional CO2 laser 10,600nm session, every month for 4 months
15924814|NCT03460431|Device|Nd YAG laser1064 nm|Nd YAG laser1064 nm laser session, every month for 4 months
15924815|NCT03460418|Other|Phone contact|Assessment of the different outcomes by means of a phone contact
15924816|NCT03460405|Biological|Vi-DT Vaccine|1 dose of Vi-DT Vaccine
15924817|NCT03460405|Biological|Vi Polysaccharide Vaccine|1 dose of Vi Polysaccharide Vaccine
15924818|NCT03460405|Biological|IPV Vaccine|1 dose of IPV Vaccine
15924819|NCT03460392|Drug|Antibiotic therapy|To evaluate the effects of a specific event (i.e. surgical operation) or therapy (i.e antibiotic treatment) over time;
15924820|NCT03460379|Drug|Escitalopram|Patients are tested for their normal prescription escitalopram medication
15924821|NCT03460366|Drug|Enalapril|Patients are tested for their normal prescription enalapril medication
15924822|NCT03460353|Drug|Dexamphetamine|Patients are tested for their normal prescription dexamphetamine medication
15924823|NCT03460340|Device|prefrontal deep rTMS of H1 Coil|prefrontal deep rTMS of H1 Coil
15924824|NCT03460327|Drug|Candesartan|Patients are tested for their normal prescription candesartan medication
15924825|NCT03460314|Drug|Buprenorphine|Patients are tested for their normal prescription buprenorphine medication
15924826|NCT03460288|Behavioral|Retraining (AAT)|The training program is based upon the approach-avoidance task (AAT) and can be easily performed on a computer, laptop or tablet. There is a total of 20 pictures, 10 slot-machine gambling related pictures and 10 neutral pictures that were already used in a prior study (Wittekind et al., submitted). The pictures appear on the computer screen and have to be either pushed or pulled. Pushing and pulling depends on a masked instruction (not related to the content of the pictures, but to the color of the frame). All gambling-related pictures are framed with the color that is instructed to be pushed, all neutral pictures are framed with the color that is instructed to be pulled.
15924827|NCT03460275|Drug|Osimertinib Mesylate Tablets|Osimertinib 80mg oral administration daily until progression or occurring intolerable treatment-related toxic effects or patients withdrawing informed consent(Based on whichever occurs first)
15924828|NCT03460262|Device|Standard cutiplast®|Our standard dressing consists in a usual ready-to-use Smith and Nephew Cutiplast®. This dressing is open 48 hours after the operation (CDC recommendation) for the first time and then changed every day after wound disinfection.
15924829|NCT03460262|Device|PICO®|PICO® is a negative pressure wound therapy consisting in a 4 layers ready-to-use dressing connected to a small console, responsible for the aspiration. The system is canister free. The fluid drained from the wound is lost by evaporation for 80% of it and only 20% remains in the dressing. This permits to the dressing to be kept in place for maximum 7 days. The wound is not checked during the hospital stay, allowing the patient to leave the hospital earlier after the operation.
15924830|NCT03460249|Other|BP measurement|the BP will be measured in the chair position followed by the table position and also in the reverse sequence
15924831|NCT03460223|Biological|MSC|conventional plus MSC or placebo treatment
15924832|NCT03460210|Drug|Atomoxetine|Patients are tested for their normal prescription atomoxetine medication
15924833|NCT03460197|Procedure|Endoscopic Ultrasound-Guided Fine-Needle Aspiration|Patients will be submitted to both techniques of tissue acquisition in the same procedure of endoscopic ultrasound. Capillarity technique, requires not remove the stiletto from the needle until the punctures are done for the biopsy sampling. Wet suction technique, requires saline solution to replace the air column. Samplings will be placed in two different jars, where Jar 1 corresponds to Capillarity Technique sampling and Jar 2 to Wet Technique. Once the sampling preparation is concluded will be send to the Pathology Department to be subsequently blindly analyzed by two independent pathologists, that means they would not be aware of the tissue acquisition method used in each of the microscopic slides to analyze.
15924834|NCT03460184|Diagnostic Test|G.A Group A:|"G.A will be conducted After pre-oxygenation for 3-5 minutes. thiopental (5 mg/kg) will be administered I.V, followed by succinylcholine 1.5 mg/kg. After tracheal intubation, the patients will be ventilated with 100% oxygen. isoflurane 0.8% will be added, to maintain the anesthesia. Further neuromuscular block will be maintained by using atracurium . After delivery of the fetus, fentanyl IV will be given 1ug/kg as analgesia and 20 IU oxytocin will be given by I.V infusion .Reverse neuromuscular blockade as necessary at completion of surgery. Extubate when the patient is awake
~In the sitting position and after complete asepsis , 2-3 ml of Lidocaine will be injected subcutaneously, spinal anesthesia will be performed at interspace L3-4 or L4-5, midline approaches using 22 guage Quinke needle . 2.5 ml of hyperbaric bupivacaine 0.5% in addition to 25 μg fentanyl will be injected into the subarachnoid space after successful dural puncture and confirmation by barbotage."
15924835|NCT03460158|Drug|Restylane-L®|Restylane-L® for the indication for mid-to-deep dermal implantation for moderate to severe facial wrinkles and folds, such as nasolabial folds.
15924838|NCT03460145|Other|Lavender Oil on Nasal Strip (Lx)|Usage of Aromatherapy for Preoperative Anxiety
15924841|NCT03460132|Device|Tomas® Anchorage System - DENTAURUM|self drilling, bone inserted, screw like device used for anchorage preparation during orthodontic treatment.
15924842|NCT03460119|Device|High Flow Nasal Cannula Oxygen|The high flow device that we used was an air oxygen blender (Whisper FlowⓇ), which allows FiO2 adjustment between 0.30 and 1.0 and can deliver a gas flow from 10 to 150 l/min. The gas mixture was routed from a heated humidifier (MR850 with MR 290 chamber) through a one line heated inspiratory circuit (RT241) to the subject at a temperature of 37°C via a nasal cannula (OptiflowⓇ).
15924843|NCT03460080|Diagnostic Test|AFP-L3 and PIVKA-II in HCC|"Serum samples are tested for tumor markers including PIVKA-II, AFP, AFP-L3% and biochemical tests.
~Imaging: CT or MRI"
15924844|NCT03460067|Radiation|Omission of Radiation|No Radiation will be given. 1 year of trastuzumab +/- pertuzumab treatment will be given with 5 years of follow up occurring every 3 months to check for recurrence
15924845|NCT03460041|Drug|Magnesium Sulfate|caudal magnesium sulphate added to bupivacaine for pain management
15924846|NCT03460041|Drug|Dexmetedomedine|Caudal dexmetedomedine added to bupivacaine for pain management
15924847|NCT03460041|Drug|Bupivacaine|Caudal bupivacaine for pain management
15924848|NCT03460028|Behavioral|Yoga Condition|Participants randomized to the Yoga Condition will participate in an integrated yoga program consisting of yoga postures, breathing exercises, and concentration/meditation practices.
15924849|NCT03460015|Drug|Sevoflurane|"During the first 30 minutes after randomization, patients will be treated with propofol (same dosage as the propofol group).
~Once the AnaConDa® system is installed, sevoflurane administration will begin (propofol is stopped)."
15924850|NCT03460015|Drug|Propofol|"In the control group, sedation will be maintained with the above objective (RASS between -4 and -5, BIS between 40 and 60) until the patient is extubated.
~In the sevoflurane group, propofol is administrated during the first 30 minutes after the randomization and when the AnaConDa® system is installed propofol is stopped."
15924851|NCT03460002|Biological|Measles vaccine|A measles vaccine prequalified from the World Health Organization will be administered in one dose by deep subcutaneous injection into the left subscapular region by a local nurse.
15924852|NCT03460002|Biological|Oral polio vaccine|A bivalent oral polio vaccine prequalified by the World Health Organization will be administered in one or two doses directly into the mouth of the vaccinee with two drops per dose by a local nurse.
15924853|NCT03459989|Diagnostic Test|Ultrasound|Samsung H60 Ultrasound
15924854|NCT03459976|Diagnostic Test|evaluate serum level HE4 in endometrial cancer|"HE4 in beignin endometrial diseases
~HE4 in endometrial cancer"
15924855|NCT03459963|Device|indwelling urinary catheter|85 women undergoing first elective CS will be catheterized immediately preoperatively using Foley's catheter by applying catheterization precautions.
15924856|NCT03459937|Behavioral|Hatha Yoga Intervention|Hatha Yoga will focus on a restorative style of Hatha yoga. Total duration will begin at 100 minutes per week and will gradually progress in 4-week intervals until achieving the prescribed dose of 300 min/wk (5 days per week for 60 minutes per day). While attending the behavioral group sessions the participants will also engage in a supervised yoga session with a trained yoga instructor. To facilitate the additional 4 days of unsupervised yoga, we will provide yoga videos that mimic the asanas (poses) and flow patterns that are taught in the supervised yoga sessions. The intervention includes prescribed dietary recommendations based on the participants' baseline body weight, and self-monitoring diaries, meal plans, and sample recipes will be provided. Intervention lessons will also include information related to behavior strategies for achieving the recommended calorie and fat intake goals. Participants will also be provided weekly group intervention sessions across the study period.
15924857|NCT03459937|Behavioral|Vinyasa Yoga Intervention|Vinyasa Yoga will focus on a more vigorous form of yoga. Total duration will begin at 100 minutes per week and will gradually progress in 4-week intervals until achieving the prescribed dose of 300 min/wk (5 days per week for 60 minutes per day). While attending the behavioral group sessions the participants will also engage in a supervised yoga session with a trained yoga instructor. To facilitate the additional 4 days of unsupervised yoga, we will provide yoga videos that mimic the asanas (poses) and flow patterns that are taught in the supervised yoga sessions. The intervention includes prescribed dietary recommendations based on the participants' baseline body weight, and self-monitoring diaries, meal plans, and sample recipes will be provided. Intervention lessons will also include information related to behavior strategies for achieving the recommended calorie and fat intake goals. Participants will also be provided weekly group intervention sessions across the study period.
15924858|NCT03459911|Drug|Cozaar 100mg Tablet|Cozaar® ( Losartan potassium) 100 mg Tablets(Merck Sharpe & Dohme B.V. , Haarlem, the Netherlands)
15924859|NCT03459911|Drug|Losartan potassium 100mg|Losartan potassium 100 mg Tablets ( Pharmtechnology LLC, Republic of Belarus)
15924860|NCT03459898|Device|AlignRT system (VisionRT Ltd., London, UK)|To review our institutional clinical experience of applying the AlignRT system to monitor patient setup and reproducibility when using ABC and DIBH techniques in the treatment of left-sided breast cancer patients.
15924861|NCT03459885|Device|Paired associative stimulation (with eXimia magnetic stimulator and Dantec Keypoint® electroneuromyography device)|Paired associative stimulation (PAS) administered several times per week for 8 weeks to lower limbs. PAS comprises transcranial magnetic stimulation (eXimia magnetic stimulator, Nexstim Ltd, Helsinki, Finland) and peripheral nerve stimulation (given with Dantec Keypoint® electroneuromyography device (Natus Medical Incorporated, Pleasanton, CA, USA)).
15924862|NCT03459872|Procedure|Acupuncture|Alternative medicine therapeutic intervention
15924863|NCT03459872|Device|RU-Fit|FDA approved medical device for the measurement of fine motor control
15924864|NCT03459859|Drug|Pevonedistat|Administered intravenous (IV) infusion over one hour on Days 1, 3 and 5 of each cycle, after administration of LDAC per protocol.
15924865|NCT03459859|Drug|Cytarabine|Low dose Cytarabine (LDAC) administered subcutaneously (SC) daily for 10 days of every 28-day cycle.
15924866|NCT03459846|Drug|Durvalumab|Durvalumab 1500 mg IV q4w
15924867|NCT03459846|Drug|Olaparib|Olaparib PO 300 mg BID adjusted based on patient's creatinine clearance.
15924868|NCT03459846|Drug|Placebo|Matching placebo for oral tablet BID
15924981|NCT03458897|Diagnostic Test|serial functional magnetic resonance imaging (MRI)|All subjects with sickle cell disease undergoing bone marrow transplantation will undergo up to 4 functional MRI scans.
15926075|NCT03449758|Drug|Azathioprine|Pharmaceutical form:Tablet Route of administration: Oral
15924869|NCT03459833|Drug|Hyaluronic Acid|Glans penis augmentation using multiple puncture technique as described by Abdallah et al. (2012) with minor modifications. HA is injected at two circular levels: one at the level of corona of glans penis and a second circular level is mid-way between the corona and urethral meatus. Six injections are injected at coronal level and four are injected in the second level, each injection is of 0.2 ml and is injected into deep dermis.
15924870|NCT03459820|Diagnostic Test|18F-DCFPyL PET/CT|18F-DCFPyL Positron Emission Tomography/Computed Tomography Scan
15924871|NCT03459807|Drug|Anti-Hypertensive medications|Use of standard Anti-Hypertensive medications
15924872|NCT03459807|Procedure|Dry Weight Adjustment|The participant's target post-dialysis dry weight is adjusted
15924873|NCT03459794|Drug|Ivermectin|150 mcg/kg ivermectin, by mouth.
15924874|NCT03459794|Other|Placebo|An oral placebo will be administered, once
15924875|NCT03459781|Behavioral|Cognitively-Based Compassion Training|CBCT® was designed at Emory University by Lobsang Tenzin Negi. CBCT® is a secular adaptation of techniques derived from traditional Tibetan Buddhist methods for cultivating compassion known as lo-jong. Over the course of 8 weeks there will a total of 8 CBCT® sessions, one session per week, led by the CBCT® instructor. Dyads will attend the weekly CBCT® classes together. Each weekly session will last for 90 minutes and will begin with brief meditation to focus attention. The instructor will then articulate content and goals of the current week, after which a group discussion led by the instructor will take place. A session will end with a 20-30 minute meditation. Dyads will be encouraged to practice a minimum of 10 minutes per day at home, and together as a dyad if possible.
15924876|NCT03459781|Behavioral|CHE (Cancer Health Education)|The cancer health education (CHE) intervention is an adaptation of the in-person program called Health Discussion, a protocol used by our group previously. The CHE will focus on relevant topics to health and cancer including 1) cancer advocacy, 2) health and cancer biology, 3) nutrition, 4) lifestyle interventions such as physical activity and goals for physical activity, 5) the importance of good sleep, 6) the impact of stress, and 7) mental health and social support. CHE will also discuss current events related to cancer. Over the course of 8 weeks there will be a total of 8 sessions, one session per week. Each session will last for approximately 90 minutes.
15924877|NCT03459755|Behavioral|Physical Activity|"Patients will have a baseline assessment by undergoing a maximal exercise testing protocol.
~For 12 weeks, patients will participate in an exercise session 3 days per week
~The patient will then enter a 12 week Step Down program in which the number of sessions is decreased to every week, then every 3 weeks.
~After the second 12-week period, the patient will enter a 28-week follow up period of unsupervised exercise."
15924878|NCT03459742|Behavioral|Gamification strategy|"The intervention is a gamification strategy, including game elements such as points, levels and rewards. Points are scored by completion of healthy challenges, i.e. a healthy snacks challenge, a steps challenge and activity challenge. Intervention takes place for 8 months from Mar to Nov. There will be three levels. Level 1 at baseline, level 2 expected at month 4 by 100% of participants and level 3 expected in month 8 by 70% of participants. A new cycle will start in 2019.
~Rewards include an initial reward (Starting Kit), a structural reward and an activity reward. The Starting Kit is a box with souvenirs, information for students and teachers. A structural reward, at level 2, will be achieved collectively by all participating classes in one school. It consists of school infrastructure improvements to promote a healthy nutrition and PA (eg. climbing wall, shared bicycles, sports equipment). An activity reward (AR), when reaching level 3, consists of a fun and healthy activity."
15924879|NCT03459729|Drug|Antitumor B|Study participants will take the natural botanical compound ATB during a short window (seven to 28 days). It will be administered at a dose of 1200 mg three times per day (roughly spaced every 8 hours).
15924880|NCT03459716|Other|No intervention|No intervention
15924881|NCT03459703|Behavioral|Early Time-Restricted Feeding|Eat all meals between 7 am - 3 pm for an average of ≥6 days per week.
15924882|NCT03459703|Behavioral|Control Schedule|Eat all meals over a 12-hour or longer period for an average of ≥6 days per week.
15924883|NCT03459703|Behavioral|Structured Weight Loss Program|A structured weight loss program with physical activity recommendations and dietary counseling.
15924884|NCT03459690|Behavioral|Meditation|. IK is a meditation that can be learned quickly and requires approximately 12 minutes, twice a day of practice. This regimen was chosen because of its simplicity making it an excellent way to introduce meditation to beginners. IK does not incorporate a spiritual or religious focus
15924885|NCT03459690|Device|Enobio 32- EEG machine|The ENOBIO 32 EEG device is an investigational device under US federal law which is a 24-bit EEG data reader which is a wearable wireless device
15924886|NCT03459677|Behavioral|Back2School|Modular Trans-diagnostic Cognitive Behavioral Therapy treating school absenteeism in youths
15924887|NCT03459677|Other|Treatment As Usual|Aarhus municipality's treatment as usual for youths presenting school absenteeism
15924888|NCT03459664|Behavioral|RECOVER|"For each patient baseline assessment and individual support by a diagnostic and crisis resolution home treatment team is available. In addition, patients will be treated with specific interventions based on their severity grade:
~Grade 1 (mild): social support, information about mental disorder, e-therapy, consultation, self help, peer-support, supported employment.
~Grade 2 (medium): psychotherapy (stepped short-term and group therapy), if applicable medical treatment, e-therapy, peer-support, supported employment.
~Grade 3 (medium to severe): case management, psychotherapy (stepped short-term and group therapy), if applicable medical treatment, e-therapy, peer-support, supported employment.
~Grade 4 (severe): assertive community treatment, psychotherapy, medical treatment, e-therapy, peer-support, supported employment."
15924889|NCT03459664|Behavioral|Treatment as usual|"For each patient all common care options within the German health care system are available, depending on the severity grade 1 to 4.
~This includes the following options: hospital based in-patient, out-patient treatment and day care, community based health care services, general practitioners, private psychiatrists and psychotherapists, self help."
15924890|NCT03459651|Behavioral|ANS training|In-home computer-based ANS training
15924891|NCT03459638|Other|Screening for DM, ASCVD, MetS and OSAS|Finger stick analysis, questionnaires and clinical measurements
15924982|NCT03458884|Other|Cardiorespiratory interval training|A structured cardiorespiratory interval training program on an ergometer cycle 3 days a week for 8 weeks.
15925219|NCT03457103|Device|Capnometry-Assisted Training for COPD to Slow the Breath (CATCH)|Tailored intervention emphasizing slow, quiet, regular nasal breathing pattern.
15924892|NCT03459625|Behavioral|Mindfulness-Based Stress Reduction (MSBR)|MBSR includes eight weekly 2.5-hour group sessions, a day-long (6hr) meditation retreat on the weekend during week six, 45 minutes of daily home practice guided by instructional audio CDs, and an MBSR parent workbook. Formal mindfulness exercises aim to increase the capacity for mindfulness and include a body scan, mindful yoga, and sitting meditation. Participants are also taught to practice mindfulness informally in everyday activities. In session, didactic instruction on stress physiology and using mindfulness for coping with stress in daily life is provided. Participants practice formal mindfulness exercises, break into dyads to discuss their daily homework practice, and meet as a larger group to ask questions related to the practice of mindfulness in everyday life.
15924893|NCT03459625|Behavioral|Psychoeducational Support Group (PE)|The PE consists of 8-weekly 2.5-hour sessions, a day-long (6hr) Family Resource Fair during week six, daily homework that includes monitoring progress on goals identified at the end of each session, and a workbook for parents of children with special needs that provides parents with information regarding their child's development, disability, and associated considerations. Weekly topics for discussion include Preparing for Individualized Education Plan (IEP) meetings, Communicating with Teachers, Advocacy, Sibling Issues, and Community Resources.
15924894|NCT03459612|Drug|Lasmiditan|Administered orally
15924895|NCT03459612|Drug|Placebo|Administered orally
15924896|NCT03459612|Drug|Diphenhydramine|Administered orally
15924897|NCT03459599|Drug|Prophylactic antibiotics|Amox-clav given to eligible women as per existing protocol, which is 625mg three times a day, for a week
15924898|NCT03459599|Other|No prophylaxis (Amox-clav withheld)|Withholding Amox-clav, which is the current local practice for women with ragged placental membranes. This was replaced with appropriate counselling on signs and symptoms of endometritis, when and where women should present if the symptoms above occur. A follow up phone call was performed at 2 weeks and 6 weeks postpartum to ascertain well-being of patients
15924899|NCT03459586|Other|9zest app facilitated exercise|The purpose of this study is to determine if the 9zest app for Parkinson's disease is feasible, safe, and efficacious when used independently by individuals with Parkinson's disease
15924900|NCT03459573|Behavioral|"One Drop | Experts On Track"|Participants with T2D will use One Drop's digital therapeutics solution (app, meter, and 'On Track' in-app coaching) for 3 months
15924901|NCT03459573|Behavioral|"One Drop | Experts On Call"|Participants with T1D will use One Drop's digital therapeutics solution (app, meter, and 'On Track' in-app coaching) for 3 months
15924902|NCT03459573|Behavioral|"One Drop | Experts Revive"|Participants with pre-diabetes will use One Drop's digital therapeutics solution (app, meter, and 'Revive' in-app coaching) for 3 months
15924903|NCT03459560|Drug|PolyPill|After the baseline enrollment and excluding non-eligible participants, we randomized villages to Polypill and control arms. Follow-ups are scheduled for 1, 3, and 6 months after the initial enrollment in the Polypill arm and every six months thereafter. For the minimal care arm, the follow-ups are arranged every six months.
15924904|NCT03459547|Device|dental implant|Local anesthesia, flap preparation, dental implant insertion, flap suture, healing abutment insertion. Peri-implant soft tissue samples taken prior to implant placement and 24 hours after.
15924905|NCT03459534|Drug|Radotinib HCl|"Brand name/manufacturer: Supect Cap./IL-YANG PHARM. Co., Ltd.
~Active ingredient: radotinib HCl 106.8mg (100mg as radotinib) or HCl 213.6mg (200mg as radotinib)
~Appearance and formulation: hard capsule with a light blue cap and a body containing pale yellow powder
~Storage conditions: Store in an airtight light proof container at room temperature."
15924906|NCT03459521|Biological|Fendrix|Administer hepatitis B virus vaccine (Fendrix®) at standard doses (0,1, 2 and 6 months) in patients with chronic liver disease that have not been vaccinated previously and not immunised
15924907|NCT03459508|Diagnostic Test|Ophthalmological examination|Detailed anterior segment examination using slit-lamp biomicroscopy for signs of anterior uveitis, and detailed fundus examination using slit-lamp fundus biomicroscopy with + 90 diopter lens searching for signs of vasculitis and posterior uveitis.
15924908|NCT03459495|Device|therapeutic ultrasound|Patients in the ultrasound group will be administered to the posterior neck region for 5 minutes in pulsed mode (pulse rate 1: 1) at 1 MHz, 1.5 W / cm2. The treatment will be done 5 days a week for a total of 10 days
15924909|NCT03459495|Device|placebo ultrasound|When the ultrasonic device is in the closed position, the ultrasonic probe will be applied for 5 minutes in the posterior neck region of the patients. The treatment will be done 5 days a week for a total of 10 days.
15924910|NCT03459482|Other|Food Elimination Diet|Subjects asked to participate in a food elimination diet, either True or Sham to evaluate the effects on their IBS symptoms
15924911|NCT03459469|Drug|Tegavivint|This is an Investigational drug
15924912|NCT03459456|Behavioral|Provocation OC task (Provoc)|used to evoke OC-related distress
15924913|NCT03459456|Behavioral|Trier Social Stress Test (TSST)|used to evoke anxiety unrelated to OCD (e.g., performance anxiety)
15924914|NCT03459456|Behavioral|Exposure provocation task|used to elicit overt OCD rituals
15924916|NCT03459430|Other|Core stability training|Effect of different core stability programs using diverse training intensities
15924917|NCT03459417|Procedure|intrathecal morphine+LA|Lumbar puncture will be performed in the sitting position. A 25 gauge (pencil point, Braun, Melsungen, Germany) spinal needle will be introduced into the subarachnoid space at the L3-L4 lumber level midline approach with the needle orifice cephalad. Cerebrospinal fluid will be aspirated and the ready mixture will be injected to subarachnoid space over the period of 15 s, with barbotage. patients will receive intrathecal LA 15 mg (3 mL) (hyperbaric bupivacaine 0.5%) intrathecal with 0.5 mg preservative free morphine + magnesium sulfate 100 mg.
15924918|NCT03459417|Procedure|intrathecal morphine+LA+ Mg sulp. 50|Lumbar puncture will be performed in the sitting position. A 25 gauge (pencil point, Braun, Melsungen, Germany) spinal needle will be introduced into the subarachnoid space at the L3-L4 lumber level midline approach with the needle orifice cephalad. Cerebrospinal fluid will be aspirated and the ready mixture will be injected to subarachnoid space over the period of 15 s, with barbotage.patients will receive intrathecal 15 mg (3 mL) of hyperbaric bupivacaine 0.5% intrathecal +0.5 mg preservative free morphine + magnesium sulphate 50 mg.
15925460|NCT03455075|Drug|Placebo oral capsule|Placebo capsules that look like DMAU and LNG capsules but with no active ingredients.
15924919|NCT03459417|Procedure|intrathecal morphine+LA+ Mg sulp. 100|Lumbar puncture will be performed in the sitting position. A 25 gauge (pencil point, Braun, Melsungen, Germany) spinal needle will be introduced into the subarachnoid space at the L3-L4 lumber level midline approach with the needle orifice cephalad. Cerebrospinal fluid will be aspirated and the ready mixture will be injected to subarachnoid space over the period of 15 s, with barbotage.patients will receive intrathecal 15 mg (3 mL) of hyperbaric bupivacaine 0.5% intrathecal with 0.5 mg preservative free morphine + magnesium sulphate 100 mg.
15924920|NCT03459404|Combination Product|Sufentanil NanoTab PCA System|15 mcg Sufentanil NanoTab self-administered sublingually up to every 20 minutes as needed for pain for at least 48 hours and up to 72 hours
15924921|NCT03459391|Drug|XC221 60 mg|The volunteers received the study drug once, and then continued daily intake for 5 days after a 6-day break.
15924922|NCT03459391|Drug|XC221 200 mg|The volunteers received the study drug once, and then continued daily intake for 5 days after a 6-day break.
15924923|NCT03459391|Drug|Placebo|The volunteers received the study drug once, and then continued daily intake for 5 days after a 6-day break.
15924924|NCT03459378|Other|no intervention - retrospective analyses|retrospective data examination, there are no study related interventions
15924925|NCT03459365|Device|Euflexxa|Aspirations performed before each injection and at six weeks.
15924926|NCT03459352|Other|ePRO|"Patients will be instructed to log symptoms with an ePRO app using their own personal devices, and prompted once per month for 12 months to log symptoms.
~These participants will be sent an Adverse Event Questionnaire (AEQ) via the Noona tool that summarizes their symptoms and distress once per month and one week prior to any medically indicated oncology clinic visit.
~Symptoms designated as clinically severe either during regular symptom logging or via the AEQ will trigger a prompt to contact the clinical team for immediate follow-up. Participants will complete a follow-up questionnaire at 6 months and 12 months following enrollment that includes a self-report of symptom burden, HRQOL, and satisfaction."
15924927|NCT03459339|Device|Tethered Capsule Endomicroscopy (TCE)|Tethered Capsule Endomicroscopy will be used to detect Barrett's Esophagus
15924928|NCT03459326|Other|IIEF (International Index of Erectile Function questionnaire )|"The questionnaire is presented and answered without help. Answers to the IIEF Questionnaire will be collected in order to obtain the following scores (the total score is of no interest):
~Erectile function (score 1 to 30)
~Orgasmic function (score 0 to 10)
~Desire (score 2 to 10)
~Sexual satisfaction (score 0 to 15)
~Overall satisfaction (score 2 to 10)"
15924929|NCT03459313|Other|Active group|For this study, the Frisk.Friidrott (Healthy.Athletics/Track&Field) website has been developed. The purpose of the website is to provide an easy-to-use tool that can assist coaches and parents involved in youth athletics with information how to structure training and recovery planning, provide guidance on possible injuries, and provide other information on health for youth athletes.
15924930|NCT03459287|Device|INTERCEPT|Pathogen reduced RBCs
15924931|NCT03459287|Device|Control|Conventional RBCs
15924932|NCT03459274|Device|VR-Biofeedback|The intervention uses a smart phone with a virtual reality app; a headset that connects to the phone and has goggles that contribute to the 3 dimensional, interactive, and surrounding aspects of the experience; headphones through which subjects hear calming sounds and guiding voices from the experience; an attached microphone that allows subjects to monitor their breathing and interact with their environment through their breath; and a heart rate monitor whose realtime data on variability has an affect on the virtual environment. The virtual reality experience guides subjects through deep breathing exercises. Subjects will attempt to match a certain slow breathing rate, and pulse and breathing rate will cause non-stressful changes to the environment.
15924933|NCT03459261|Diagnostic Test|blood sample on admission (ADD), first postoperative day (POD1) and fourth postoperative day (POD4)|Laboratory analyses of peripheral venous blood on admission (blood sample ADD), 24 hours after surgery (blood sample POD1) and fourth-day after surgery (blood sample POD4) included biochemical analysis, complete blood count, C-reactive protein (CPR), procalcitonin (PCT), albumin/protein level, prothrombin time and international normalized ratio (INR) (only on admission) and for determination of cytokines: tumor necrosis factor alpha (TFN-α), interleukin-6 (IL-6), interleukin-10 (IL-10).
15924934|NCT03459248|Other|Dual therapy|combination of 10 mg metoclopramide with 4 mg ondansetron
15924935|NCT03459248|Other|Monotherapy|10 mg metoclopramide
15924936|NCT03459248|Other|General anesthesia|Induction of general anesthesia will be performed followed by endotracheal intubation.
15924937|NCT03459235|Other|quality of life|Assessment of the impact of digestive sequelae (LARS score) and genitourinary sequelae (score IPSS, USP, FSFI et IIEF) in Patients With Rectal Cancer using validated questionnaires on quality of life (EORTC QLQ-C30 et QLQ-CR 29).
15924938|NCT03459222|Biological|Relatlimab|Specified dose on specified days
15924939|NCT03459222|Biological|Nivolumab|Specified dose on specified days
15924940|NCT03459222|Drug|BMS-986205|Specified dose on specified days
15924941|NCT03459222|Biological|Ipilimumab|Specified dose on specified days
15924942|NCT03459209|Other|tube feeding|The obtained milk aliquots undergo in vitro administration through three different tube feeding techniques.
15924943|NCT03459196|Device|THERMOCOOL SMARTTOUCH SF-5D Catheter|radiofrequence ablation with THERMOCOOL SMARTTOUCH® SF-5D catheter used in combination with the nMARQ™ Multi-Channel RF Generator with TGA mode
15924944|NCT03459183|Device|Infrasound (85 dB; 6Hz) source|the infrasound source will emit inaudible 6Hz sound for 8 consecutive hours during participant's night sleep, local sound pressure (at participants head) will be calibrated at 85 dB
15924945|NCT03459183|Device|Ultrasound (10dB below hearing threshold; 22.4 kHz) source|the ultrasound source will emit inaudible 22.4 kHz sound for 8 consecutive hours during night sleep
15924946|NCT03459183|Device|Infrasound dummy source|the infrasound dummy source looks exactly like the according verum infrasound source but produces absolutely no sound
15924947|NCT03459183|Device|Ultrasound dummy source|the ultrasound dummy source looks exactly like the according verum ultrasound source but produces absolutely no sound
15924948|NCT03459170|Biological|BPX-501 T cells|Biological: T cells transduced with CaspaCIDe® safety switch
15924949|NCT03459170|Drug|rimiducid|administered to kill BPX-501 cells in the event of GVHD
15925140|NCT03457701|Drug|rhEPO|rhEPO (epoetin alfa OR darbepoetin alfa) is commercially available in various single dose vials and single-dose prefilled syringes. It will be given as subcutaneous injection.
15924950|NCT03459157|Drug|HIV prevention package including PrEP|All MSM enrolled will benefit from a comprehensive HIV prevention package including quarterly clinical examinations, screening and treatment of STIs, screening of HIV, PrEP (TDF 300 mg + FTC 200 mg), daily or on-demand, according the participant's choice, immunisation against hepatitis B, individualised peer-led support (for adherence and prevention), group discussions, condoms, and lubricants.
15924951|NCT03459144|Drug|verteporfin|Participants will receive the intravitreal ranibizumab treatment (0.05mg) at baseline and additional intravitreal ranibizumab(0.05mg) will be given to the participants when necessary（every three months）.
15924952|NCT03459144|Drug|verteporfin and ranibizumab|Participants will be given the standard verteporfin photodynamic therapy followed by intravitreal ranibizumab (0.05mg) 72h after the PDT treatment at baseline. Additional verteporfin photodynamic therapy and intravitreal ranibizumab (0.05mg) will be given to the participants when necessary.
15924953|NCT03459131|Device|Comfilcon A with Digital Zone Optics™ contact lenses|Silicone hydrogel spherical contact lenses with Digital Zone Optics™
15924954|NCT03459131|Device|Comfilcon A contact lenses|Silicone hydrogel spherical contact lenses
15924955|NCT03459118|Behavioral|Function Focused Care|The intervention in the parent study involves the use of a participatory implementation approach as delineated in the Evidence Integration Triangle. Prior to implementation, we meet with the administrator, service coordinator, delegating or oversight nurse or setting contact designee to identify the setting champion and stakeholder team members. In addition to the champion, we recommend the following individuals be included in the stakeholder team: an administrator in a leadership position (e.g. assisted living manager, delegating/overseeing nurse); a direct care worker; a family member; an activity staff member if available; and a resident. FFC-AL-EIT is implemented by a Research Nurse Facilitator working with the stakeholders using our four step approach: (I) Environment and Policy Assessments; (II) Education; (III) Establishing Resident Function Focused Care Service Plans; and (IV) Mentoring and Motivating.
15924956|NCT03459105|Procedure|Ultrasound-assisted paramedian spinal anesthesia|A preprocedural ultrasound scanning will be done, and skin marking will be made. The needle entry point and insertion angle will be determined based on ultrasound scanning. Spinal anesthesia will be performed via paramedian approach.
15924957|NCT03459105|Procedure|Landmark-guided spinal anesthesia|Spinal anesthesia will be done using conventional landmark-guided technique.
15924958|NCT03459105|Drug|0.5% heavy bupivacaine|0.5% heavy bupivacaine will be administered into intrathecal space. The dose of local anesthetic injected for spinal anesthesia will be at the discretion of the attending anesthesiologist. The dose range of intrathecal bupivacaine will be between 12 and 16 mg.
15924959|NCT03459092|Drug|Botulinum toxin type A|Botulinum toxin injection in the horizontal extraocular muscles.
15924960|NCT03459092|Procedure|Strabismus surgery|Strabismus surgery on the horizontal extraocular muscles
15924961|NCT03459079|Drug|Lanifibranor|The film-coated tablet contains 400 mg of the active ingredient lanifibranor (IVA337) for an immediate release formulation. Participants receive 800mg/ day
15924962|NCT03459079|Other|Placebo|Film-coated tablets with a core containing 900 mg of a physical mixture of lactose monohydrate, microcrystalline cellulose, pre-gelatinized starch and magnesium stearate serve as placebo.
15924963|NCT03459066|Diagnostic Test|Institution-Group|"The study includes three measurement times:
~Time 1 (T1): corresponds to the first measurement, which will take place between the 3rd and 10th day of hospitalization.
~Time 2 (T2): corresponds to the second measurement, which will be carried out 3 months after the first measurement.
~Time 3 (T3): corresponds to the third measurement, which will be carried out 12 months after the first measurement.
~The evaluations will be tone, functionality and quality of life."
15924964|NCT03459053|Behavioral|CBART|Cognitive Behavioral protocol that uses art-making for stress reduction and cognitive interventions
15924965|NCT03459040|Drug|Alpha 1-Antitrypsin|AAT will be given either in the hospital or the outpatient clinic two times per week.
15924966|NCT03459027|Dietary Supplement|Super Beets|Nitrate rich beetroot powder (10g) acutely
15924967|NCT03459027|Dietary Supplement|Beetroot powder|Nitrate devoid beetroot powder (10g) acutely
15924968|NCT03459014|Other|Stimulus rich VE|Participants will walk in the Lokomat with the VR for 21 minutes. After every 7 minutes, the speed of the OF will change (2 times the comfortable walking speed, equally to the comfortable walking speed, and 0.5 times the comfortable walking speed).
15924969|NCT03459014|Other|Stimulus poor VE|Participants will walk in the Lokomat with the VR for 21 minutes. After every 7 minutes, the speed of the OF will change (2 times the comfortable walking speed, equally to the comfortable walking speed, and 0.5 times the comfortable walking speed).
15924970|NCT03459001|Other|Tube Feeding Product|a high calorie, high protein tube feed product consumed sole source per their physician's recommendation and per standard of care
15924971|NCT03458988|Device|Blood-pressure measuring (Nellcor™ Adult SpO2 Sensor)|Data will be acquired for 10 minutes with a reusable off the shelf adult SpO2 sensor. The Nellcor™ Adult SpO2 Sensor, model DS-100A, is indicated for use when continuous noninvasive arterial oxygen saturation and pulse rate monitoring are required for patients weighing greater than 40 kg.
15924972|NCT03458975|Radiation|MRI|Magnetic Resonance Imaging
15924973|NCT03458975|Radiation|Perfusion CT scan|Perfusion Computerized tomography scan
15924974|NCT03458975|Other|Contrast enhanced ultrasound|Contrast enhanced ultrasound
15924975|NCT03458975|Drug|Sonoporation|Gaseous microbubbles (Sonovue) combinated with Ultrasounds
15924976|NCT03458962|Genetic|Genetic Enrollees|Identification of new genetic diagnoses in children with multiple congenital anomalies, developmental delay, autism, seizures, intellectual disabilities, neurodegenerative disorders and metabolic illness. Samples and data will be stored in a pediatric biorepository. A subset of samples will undergo genetic/genomic analysis.
15924977|NCT03458949|Other|awareness campaign|awareness campaign for colorectal cancer screening in the workplace
15924978|NCT03458923|Drug|Diclofenac Sodium 0.1 ml containing 500µg|15 eyes will receive intravitreal 0.1 ml containing 500µg of Diclofenac Sodium monthly for three months
15924979|NCT03458923|Drug|Ranibizumab 0.5 mg Solution for Injection|15 eyes will receive intravitreal 0.5 mg of Ranibizumab monthly for three months
15924980|NCT03458910|Behavioral|HRV training|Participants will be asked to undergo daily practice to regulate (either increase or decrease) HRV for 5 weeks.
15925522|NCT03454529|Drug|Simvastatin|Given PO
15924984|NCT03458858|Other|Mixed Berry Diet|Mixed Berry Treatment
15924985|NCT03458858|Other|Carbohydrate Control Jello|Carbohydrate Control
15924986|NCT03458858|Other|Fiber Enriched Jello|Fiber Control
15924987|NCT03458858|Other|Low Fiber Mixed Berry Juice|Anthocyanin Control
15924988|NCT03458845|Diagnostic Test|Computed Tomography Scan|The results of the CT scan and the hand-grip test will be used for diagnosis of sarcopenia. The Royal Free Hospital-Global Assessment (RFH-GA) results will classify the nutritional status of the patient.
15924989|NCT03458832|Diagnostic Test|FSHD-specific functional rating scale|The FSHD-COM is composed of disease-relevant functional tasks such as leg function; shoulder and arm function; trunk function, hand function, and balance.
15924990|NCT03458832|Device|Electrical Impedance Myography|EIM is a non-invasive, painless, and fast technique for obtaining information on how a patient's muscle structure is changing. EIM uses a small electrical current to measure the health of the underlying muscle. The patient will be asked to lie down and a trained clinical evaluator will perform testing on 16 total muscles (8 on each side) on your arms and legs.
15924991|NCT03458819|Diagnostic Test|Isolation of peritoneal mesothelial cells|HPMCs will be isolated and stored at -80 degrees until analysis. Changes in the protein expression of EMT markers such as E-cadherin, a- SMA, Snail, and fibronectin in the HPMCs will be evaluated by Western blot analysis.
15924992|NCT03458806|Diagnostic Test|AS Algorithm 1|Machine learning algorithm, generated from ECG and PCG recordings, distinguishing moderate-to-severe or greater aortic stenosis from controls having structurally normal hearts with no greater than mild valvular heart disease at any location.
15924993|NCT03458806|Diagnostic Test|AS Algorithm 2|Machine learning algorithm, generated from ECG and PCG recordings, distinguishing moderate-to-severe or greater aortic stenosis from controls having any findings other than moderate-to-severe or greater aortic stenosis.
15924994|NCT03458806|Diagnostic Test|MR Algorithm 1|Machine learning algorithm, generated from ECG and PCG recordings, distinguishing moderate-to-severe or greater mitral regurgitation from controls having structurally normal hearts with no greater than mild valvular heart disease at any location.
15924995|NCT03458806|Diagnostic Test|MR Algorithm 2|Machine learning algorithm, generated from ECG and PCG recordings, distinguishing moderate-to-severe or greater mitral regurgitation from controls having any findings other than moderate-to-severe or greater mitral regurgitation.
15924996|NCT03458793|Behavioral|Group walking and group educational workshops|"The experimental group will take part in 12 week intervention consisting of group walking and group educational workshops.
~Group walking sessions will run once weekly for up to 45 minutes each in small groups (up to 8-9 people per group) and will be delivered by a trained walk leader once weekly for duration up to 45 minutes per session.
~Group educational workshops will be delivered in the form of a group presentation once weekly for up to 45 minutes by the research team (i.e. the PhD student) on a variety of topics focused on the healthy ageing, such as eye hygiene, mental health and well-being, preventing falls, social support, nutritional guides, physical activity recommendations for older adults and other topics"
15924997|NCT03458780|Drug|Yellow Fever Vaccine|Yellow Fever Vaccine .5 ml
15924998|NCT03458767|Behavioral|Eight weekly 90-minute group educational sessions|Eight weekly 90-minute group educational sessions, originally developed for the MAPSS-MS intervention, adapted for remote web-based delivery.
15924999|NCT03458741|Other|Glycogen Supercompensation|The subjects arrived in the morning in the overnight fasted state at day 1, day 2 and day 5. Upon arrival in the morning the subjects were given a meal corresponding to 5% of their daily energy intake (~600-800 kJ). During the 5 day supercompensation regime the subjects were provided a predefined isocaloric diet containing 80% carbohydrates, 10% fat and 10% proteins. All food items were handle out to the subjects and compliance of the diet regime was ensured by survey.
15925001|NCT03458715|Drug|SGLT2 inhibitor (Empagliflozin 25 MG)|We randomized add SGLT2 inhibitor (Empagliflozin 25 MG) or DPP4 inhibitor (Linagliptin 5 MG) to type 2 diabetes patient poorly controlled with premix insulin therapy.
15925002|NCT03458715|Drug|DPP4 inhibitor (Linagliptin 5 MG)|We randomized add SGLT2 inhibitor (Empagliflozin 25 MG) or DPP4 inhibitor (Linagliptin 5 MG) to type 2 diabetes patient poorly controlled with premix insulin therapy.
15925003|NCT03458702|Behavioral|YogaFit|For YogaFit Vinyasa Flow (referred to as YogaFit in this manuscript)], participants followed, via digital versatile disc, a standardized YogaFit format choreographed by an American Council of Exercise Certified and Registered Yoga Teacher (RYT). YogaFit was performed in the same laboratory setting and lasted 30 min. YogaFit is a westernized version of yoga that does not use Sanskrit terms (Shaw 2009). Breath was an integral part of every movement with specific breath rates for each phase of the session. The objective was to move the body with intention and purpose and be present in the body.
15925004|NCT03458702|Behavioral|Quiet Rest|Participants completed 30 min of quiet rest
15925005|NCT03458689|Procedure|Left hemicolectomy, laparoscopic technique|Left hemicolectomy, Laparoscopic technique
15925006|NCT03458676|Procedure|Advanced Magnetic Resonance Imaging Scan|"AMRI scan performed within 2 weeks before standard of care brain biopsy and tumor removal surgery.
~AMRI scan should take less than 1 hour to complete"
15925007|NCT03458676|Procedure|Standard of Care Brain Biopsy and Tumor Removal|"During the surgery, the neurosurgeon(s) uses the information collected from the AMRI to decide what area of the brain tumor will be biopsied.
~Biopsies from up to 5 locations taken before the tumor is surgically removed."
15925383|NCT03455699|Device|VenaSeal SCS|Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.
15925008|NCT03458663|Device|Prevena™ og ACTIV.A.C™ Therapy System.|A vacuum assisted (negative pressure) system, Prevena ™ and ACTIV.A.C ™ therapy system have been developed to maintain drainage on closed incisions. The system also works by altering the cytokine profile locally so that it functions anti-inflammatory, by increasing local growth factors and promoting angiogenesis19. Negative pressure wound management (NPWM) such as Prevena ™ and ACTIV.AC ™ is a widely used tool with many different variations, but the evidence of effect remains sparse and more studies are required20. We believe that in a dry and closed incision such as the one after BCL surgery, in an area exposed to stretching during healing, it must be an advantage of maintaining drainage, reducing the anti-inflammatory response and increasing angiogenesis.
15925009|NCT03458650|Drug|LXI-15028 50mg|In escalated single-dose study, the subjects in each dose group will receive single oral dose of 50 mg LXI-15028 tablet or 1 matching placebo tablet at fasted state,
15925010|NCT03458650|Drug|LXI-15028 100mg|100 mg LXI-15028 tablet or matching placebo 1 tablet at fasted state, In multiple-dose study, the subjects who administered 100mg single dose will continuously receive oral 100 mg LXI-15028 tablet or 1 matching placebo tablet once daily (QD) for 10 times.
15925011|NCT03458650|Drug|LXI-15028 200mg|single oral dose 2 100 mg LXI-15028 tablets or 2 matching placebo tablets at fasted state
15925012|NCT03458650|Drug|Placebo|matching placebo tablets
15925013|NCT03458637|Behavioral|LITE Program and Usual Care|Family based lifestyle Intervention
15925014|NCT03458637|Behavioral|Usual Care|Usual care consisting of 3 visits to weight management clinic
15925015|NCT03458611|Behavioral|Active Intervention|An audiovisual expanding (looming) stimulus is presented repeatedly to patients during the intervention (Dent & Humphreys, 2011). During the game a disk is presented to the player. This disk expands and contracts in size. The presentation of the disk coincides with the presentation of a sound that matches in frequency. The disk predicts the location where the next target will be presented. The player must discriminate between two types of target stimuli that are presented at the center of the disk. To discriminate between the two targets, the player receives a limited time window. The location of the disk and target stimuli are adjusted in real-time as a function of the player's performance. The primary goal of this algorithm is to present the multisensory looming stimuli more frequently in the contralesional field than in the ipsilesional field.
15925016|NCT03458611|Behavioral|Placebo Intervention|The active and placebo intervention are identical in all aspects except for the fact that stimulus presentation will be located in the center of the visual field.
15925017|NCT03458598|Procedure|Rectus sheath block|Rectus sheath block under ultrasound
15925018|NCT03458598|Procedure|Bilateral rectus sheath catheter|A nerve block catheter known as a continuous rectus sheath block is inserted by the surgeon at the end of the operation. An infusion of 0.2% ropivacaine is delivered through this for up to 48 hours post-operatively.
15925019|NCT03458598|Drug|Patient controlled opioid analgesia (PCA)|Patients in both groups will have PCA dilaudid or morphine prescribed for the post-operative period.
15925020|NCT03458598|Procedure|Subcutaneous injection saline placebo|Subcutaneous injection of 1ml of normal saline under ultrasound guidance at the same site bilaterally as rectus sheath blockade is performed
15925021|NCT03458585|Other|Self-administered questionnaire|Self-administered questionnaire
15925022|NCT03458572|Device|Seirin Pyonex press needle acupuncture|Acupuncture
15925023|NCT03458559|Drug|Radium-223 chloride|Intravenously 50 kBq/kg every 4 weeks. Total: 6 administrations
15925024|NCT03458559|Drug|Rhenium-188-HEDP|Intravenously 40 MBq/kg every 8 weeks. Total: 3 administrations
15925025|NCT03458546|Drug|Roflumilast|All patients will receive R-CHOP therapy at standard doses according to the standard preparation and infusion procedures of each investigational site, which is to be repeated every 21 days for a total of 6 cycles. All patients will receive a fixed oral dose of one 500 microgram (μg) tablet per day with or without food for all 21 days of each cycle, which will amount to a total of 126 doses of roflumilast.
15925026|NCT03458533|Procedure|Bariatric surgery|
15925027|NCT03458533|Behavioral|Diet and lifestyle changes|
15925028|NCT03458520|Diagnostic Test|PET/MR imaging|undergo PET/MR imaging
15925029|NCT03458520|Diagnostic Test|MR imaging|Undergo MR imaging
15925030|NCT03458520|Diagnostic Test|PET/CT imaging|Undergo PET/CT imaging
15925031|NCT03458507|Device|Switch of nocturnal NIV interface|"test the alternative interfaces (either a nasal mask for the patient used to oronasal mask or inversely an oronasal mask if the usual mask is nasal) during a one-hour diurnal NIV session. SpO2 (polygraphy), PtcCO2 will be monitored continuously during this diurnal session. Patients will use their usual NIV device prescribed at home. NIV settings will be adapted if needed.
~Interface switch
~unattended nocturnal polygraphy under NIV (cf details below) will be performed at home with SomnoHolter® (Nomics, Liege, Belgium), synchronized with transcutaneous partial pressure in CO2 (PtcCO2) monitoring by SenTec V-Sign™ System.
~The PtcCO2 device will be calibrated before and at the end of each night to allow drift correction."
15925032|NCT03458494|Other|Mediterranean Diet|Participants will receive meals traditionally consumed in Mediterranean countries
15925033|NCT03458494|Other|Low-fat diet|Participants will receive meals with a low content of total fat.
15925034|NCT03458481|Drug|SOF|400 mg tablet administered orally once daily
15925035|NCT03458481|Drug|DAG181|Capsule administered orally once daily
15925036|NCT03458468|Drug|Tranexamic Acid|1g Tranexamic acid prior to skin incision
15925037|NCT03458468|Drug|Saline|Equivalent volume of saline prior to skin incision
15925038|NCT03458455|Diagnostic Test|Magnetic Resonance Imaging|Vessel Architectural Imaging is an MRI-based tumor diagnostic framework providing a powerful tool for non-invasive, in vivo assessment of diagnostic biomarkers relevant for these new therapy forms; microvascular function and tumor oxygenation.
15925039|NCT03458455|Radiation|Stereotactic Radiosurgery|A non-surgical radiation therapy used to treat tumors of the brain. It can deliver precisely-targeted radiation in fewer high-dose treatments than traditional therapy, which can help preserve healthy tissue.
15925040|NCT03458455|Drug|Ipilimumab, nivolumab or pembrolizumab|A type of therapy that uses substances to stimulate the immune system to help the body fight cancer by blocking inhibitory receptors on lymphocytes to overcome immune tolerance.
15925141|NCT03457701|Drug|Ferrous sulfate containing the stable iron isotope (57Fe)|57Fe will be available in oral solution. An oral solution will be administered containing 10 mg of 57Fe as ferrous sulfate.
15925041|NCT03458442|Other|Simulation-based surgical training|"Those in the intervention group will be introduced to a variety of simulation-based surgical training techniques. Specifically, this will involve breaking down the SICS cataract surgery procedure into stages, and practicing each stage repeatedly using simulation. This sustained deliberate practice will be integrated into the six-week course, as an enhancement to the course, and not as a replacement of any part of the educational content. Within the last three weeks of the course, 'intervention' arm participants will be introduced to the artificial eyes, the Simulation-OSSCAR rubric, and be provided with ongoing feedback.
~All participants in both intervention and control arms will undertake the six-week Orbis-COS training course."
15925042|NCT03458442|Other|Standard surgical training|Standard surgical training (without bespoke training scheme using simulation and model eye). All participants in both intervention and control arms will undertake the existing six-week Orbis-COS training course, which includes 2-4 weeks of didactic lectures, surgical observation, and wet lab training with a minimum of 50 pig eye wet lab simulations per trainee. After observed mastery of wet lab pig eyes, trainees then perform hands-on training in county level hospitals. The hands-on training pairs a surgeon from the training centre to mentor the trainee through a minimum of 30 assisted surgeries and 50 independent surgeries under supervision.
15925043|NCT03458429|Drug|GMFFP|Granulocyte-Colony Stimulating Factor (G-CSF) Mobilized Fresh Frozen Plasma
15925044|NCT03458416|Drug|Cannabidiol Oral Solution|An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
15925045|NCT03458403|Procedure|Motions during gastroscopy|Recording of endoscopist and endoscope motions right after the endoscopic exam the patient came for. The endoscope is removed halfway up the esophagus and inserted into the pylorus to the descending duodenum. The gesture is repeated three times.
15925046|NCT03458390|Device|HyGIeaCare colon irrigation|PillCam COLON for visualization of bowel lining
15925047|NCT03458377|Other|Educational telephone call|Explanation of the importance of making the test. Guidelines for the usual medication of the patient. Definition of fasting, explanation of colon cleansing adjusted to the presence of predictors of poor basic preparation. Explanation of the endoscopic procedure with the elimination of erroneous concepts of the patient with respect to the procedure. Explanation of norms of action subsequent to the endoscopy. Management of scheduling, destined to improve the adherence of the patient for the test.
15925048|NCT03458364|Device|High flow nasal cannula|High-flow nasal cannula (HFNC) oxygen therapy is a recent technique delivering a high flow of heated and humidified gas. HFNC is simpler to use and apply than noninvasive ventilation (NIV) and appears to be a good alternative treatment for hypoxemic acute respiratory failure (ARF). HFNC is better tolerated than NIV, delivers high fraction of inspired oxygen (FiO2), generates a low level of positive pressure and provides washout of dead space in the upper airways, thereby improving mechanical pulmonary properties and unloading inspiratory muscles during ARF.
15925049|NCT03458364|Device|Noninvasive ventilation|Non-invasive ventilation (NIV) is the use of airway support administered through a face (nasal) mask instead of an endotracheal tube. Inhaled gases are given with positive end-expiratory pressure often with pressure support or with assist control ventilation at a set tidal volume and rate. Numerous studies have shown this technique to be as effective as, and better tolerated than, intubation and mechanical ventilation in patients with exacerbations of COPD
15925050|NCT03458351|Device|Remote ischemic preconditioning|Four cycles of 5 min of ischemia, which is induced by a blood pressure cuff in the upper arm inflated to 200 mmHg, followed by 5 min of reperfusion, during which the cuff is deflated.
15925051|NCT03458351|Device|Sham control|The same blood pressure cuff is placed around the upper arm, but the cuff is inflated to 10 mm Hg and ischemic preconditioning is not induced.
15925052|NCT03458338|Diagnostic Test|estimated glomerular filtration rate and albuminuria|chronic kidney disease according to KDIGO
15925053|NCT03458325|Combination Product|Furoscix Infusor|Furoscix Infusor, a drug-device combination product for subcutaneous delivery of Furoscix, buffered furosemide injection, 8 mg/mL (total dose = 80 mg dose) administered subcutaneously for 5 hours.
15925054|NCT03458312|Behavioral|Family and Network Consultations|"Family and Network Consultation' (FNC) seek to identify and address patients' symptoms/concerns and caregiver burden on one side and identify the resources and opportunities to ease their burdens on the other side.
~Intervention: FNC IG will receive four family consultations over 52 weeks relying on the Calgary model and Patient-reported outcome on symptom management and concerns."
15925055|NCT03458299|Behavioral|Motivational Interviewing|2 hours of motivational interviewing
15925056|NCT03458299|Behavioral|Psychoeducation|2 hours of DVD viewing and discussion
15925057|NCT03458286|Device|BRH-A2 wound healing device|Combined ultrasound and electric current stimulation (CUSECS) is a combination therapy provided by the BRH-A2 wound healing device. This study is testing the effectiveness of the treatment CUSECS. The electric current stimulation is provided by attaching small electrodes around the ulcers. A probe is used on the ulcers to provide the ultrasound waves. Both aiming to increase the blood flow to an area to increase wound healing.
15925058|NCT03458273|Procedure|Zero fluoroscopy ablation|Catheter ablation for the treatment of atrial and ventricular arrhythmia - no fluoroscopy guidance
15925059|NCT03458273|Procedure|Conventional ablation without 3D|Catheter ablation for the treatment of atrial and ventricular arrhythmia - fluoroscopy guidance only. 3D system (Every Ensite/Carto) is not allowed
15925060|NCT03458273|Procedure|Conventional ablation with 3D|Catheter ablation for the treatment of atrial and ventricular arrhythmia - fluoroscopy guidance + 3D system support (Ensite/Carto)
15925061|NCT03458260|Drug|Pixantrone|6 cycles - dose = 80mg/m²
15925062|NCT03458260|Other|Ifosfamide|6 cycles - 1500 mg/m2
15925063|NCT03458260|Other|Etoposide|6 cycles - 150 mg/m2
15925064|NCT03458260|Other|Rituximab|6 cycles - 375 mg/m2
15925065|NCT03458260|Procedure|Transplant|after 2 or 6 cycles
15925066|NCT03458247|Drug|Abiraterone acetate standard dose|1000 mg/day
15925067|NCT03458247|Drug|Abiraterone acetate escalated dose|2000 mg/day
15925137|NCT03457714|Behavioral|Guided ICBT for persons with Spinal Cord Injury|An 8-week guided internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants who have sustained a spinal cord injury. In addition to the online program, a guide with experience delivering ICBT will provide support by email or telephone once a week. The guide will spend approximately 15 minutes per week/per client.
15925138|NCT03457714|Other|Survey|Caregiver burden and mental health will be assessed through online questionnaires.
15925068|NCT03458234|Device|16 French Foley Catheter|"A Foley catheter is a medical apparatus that creates a passageway for the drainage and collection of urine. This type of catheter is made of a pliable material that indwells into an individual's bladder by way of the urethra.
~Featuring two separate channels down the tube, Foley catheters allow absolute stability and safe extraction. One channel of the catheter, by method of a balloon, is stabilized in a bladder; the other channel allows for the passage and collection of urine, by means of a leg bag or bedside drainage bag.
~Foley catheters are usually constructed out of either silicone or latex."
15925069|NCT03458221|Drug|Itraconazole|based on the predominant Signal transduction pathway analysis 'targeted therapy' will be administered
15925070|NCT03458208|Drug|Metformin|"First aIntervention Period:
~Single administered dose of Metformin (1 000 mg tablet immediate release) in a fasting condition"
15925071|NCT03458208|Drug|Glucophage®|"Second Intervention Period:
~Single administered dose of Glucophage® (1 000 mg tablet immediate release) in a fasting condition"
15925072|NCT03458208|Drug|Metformin|"Third Intervention Period:
~Single administered dose of Metformin (1 000 mg tablet immediate release) in a fed condition"
15925073|NCT03458208|Drug|Glucophage®|"Fourth Intervention Period:
~Single administered dose of Metformin (1 000 mg tablet immediate release) in a fed condition"
15925074|NCT03458195|Other|bio-banking collection|blood samples, biopsies, and surgical specimen collected in addition to usual practice
15925075|NCT03458182|Other|Added exercise|After completion of the standard exercise test, an intervention period of 2 minutes of low intensity exercise is added.
15925076|NCT03458169|Device|Therapist LEAP session feedback|A standard therapy session is being performed with a participant with the LEAP body-weight support robot. Subsequently, the therapist is answering a questionnaire to assess the clinical applicability of the robot. An observer will assess with a questionnaire whether use errors occurred during the session.
15925077|NCT03458169|Device|Participant LEAP session feedback|A standard therapy session is being performed with a participant inside the LEAP body-weight support robot. Subsequently, the participant is answering a questionnaire to assess the comfort of the robot.
15925078|NCT03458169|Device|LEAP risk control validation|The therapist rates the risk control measurements of the LEAP robot with a questionnaire, during a session with a member of the investigational team.
15925079|NCT03458156|Biological|SLE group|The patients will be assigned to systemic lupus erythematosus (SLE) group, receiving umbilical cord mesenchymal stem cell transplantation.
15925080|NCT03458156|Biological|LN group|The patients will be assigned to lupus nephritis (LN) group, receiving umbilical cord mesenchymal stem cell transplantation.
15925081|NCT03458156|Other|the control group|The patients will be assigned to the control group.
15925082|NCT03458143|Drug|Ketamine 150 ng/ml|conscious sedation in TCI-mode
15925083|NCT03458143|Drug|Remifentanil|conscious sedation in TCI-mode
15925084|NCT03458143|Procedure|Oocyte retrieval|Oocyte retrieval for In Vitro Fertilization
15925085|NCT03458143|Drug|Ketamine 200 ng/ml|conscious sedation in TCI-mode
15925086|NCT03458130|Drug|AG10|TTR stabilizer
15925087|NCT03458130|Drug|Placebo Oral Tablet|Nonactive control
15925088|NCT03458117|Genetic|Talimogene Laherparepvec (T-VEC)|a modified herpes simplex virus-1 (HSV-1) containing the gene coding for human granulocyte macrophage colony-stimulating factor (GM-CSF)
15925089|NCT03458104|Other|Cone Beam Computed Tomography|Cone Beam CT of the larynx
15925090|NCT03458104|Diagnostic Test|Acoustic/Auerodynamic testing|Records and displays real-time sound pressure level intensity, intraoral pressure, airflow rate, and fundamental frequency
15925091|NCT03458104|Diagnostic Test|Laryngovideostroboscopy|Visualization of vocal cords in slow motion. It uses a stroboscopic lamp, which generates regular flashes of light. A flexible tube is inserted in the back of the mouth or through the nose and into the throat. Video pictures are then recorded while patients are making sound.
15925092|NCT03458091|Device|THRIVE|Oxygenation during apnea using transversal humidified oxygen
15925093|NCT03458091|Device|Endotracheal intubation|Ventilation during the procedure is governed by an endotracheal tube in the trachea and mechanical ventilation
15925094|NCT03458078|Drug|Saline Solution|Spinal injection of 10 mg hyperbaric bupivacaine 0.5% (2 ml) + 100γ morphine (1ml) + 2.5 γ sufentanil (0.5ml) + 1 ml physiological saline.
15925095|NCT03458078|Drug|Magnesium Sulfate|Spinal injection of 10 mg hyperbaric Bupivacaine 0.5% (2 ml) + 100γ Morphine (1ml) + 2.5 γ sufentanil (0.5ml) + 100 mg MgSO4 (1 ml).
15925096|NCT03458078|Drug|Midazolam 5 MG/ML Injection|Spinal injection of 10 mg hyperbaric Bupivacaine 0.5% (2 ml) + 100γ Morphine (1ml) + 2.5 γ Sufentanil (0.5ml) + 2mg Midazolam (0.4 + 0.6cc physiological saline (1 ml)).
15925097|NCT03458065|Device|ICD|Implantable Cardioverter Defibrillator
15925098|NCT03458039|Behavioral|In-person CETA|The Common Elements Treatment Approach (CETA) is a transdiagnostic, multi-problem intervention designed to address adult and youth trauma, depression, anxiety, safety, and substance use. It is comprised of a small set of common elements found to be efficacious and prevalent across a range of EBTs to treat common mental health problems. CETA was designed to be flexible in the elements utilized, their order, and their dose (number of sessions) to allow counselors to address heterogeneity, comorbidity, and symptom fluctuations in and across clients. Treatment typically consists of 6 to 12 weekly, approximately 60-minute sessions delivered by lay workers.
15925099|NCT03458039|Behavioral|Telephone CETA|"For adaptation of the CETA manual for telephone delivery, the Applied Mental Health Research (AMHR) Group at Johns Hopkins University (JHU) reviewed evidence-based telehealth strategies and recommendations, telehealth ethical and legal guidelines, and clinical recommendations from telehealth providers. In addition, local TTTs in multiple contexts reviewed telehealth modifications and provided input that was incorporated into the final T-CETA manual used in this study. No changes were made to the structure, duration, and dose of CETA sessions, treatment components, or measurement-based clinical decision-making processes. Telehealth modifications, additions, and strategies were incorporated throughout the manual in delineated telehealth boxes. This way, the original manual was maintained outside of the telehealth boxes, allowing for clear identification and training of telehealth modifications for both new and existing CETA counselors."
15925139|NCT03457701|Drug|Daprodustat|Daprodustat will be available as 1 milligram (mg), 2 mg and 4 mg tablets strengths. One tablet to be taken daily without regard for food.
15925523|NCT03454516|Other|telemonitoring|the follow-up of the patient will be performed with Telemonitoring
15925100|NCT03458039|Behavioral|Treatment as Usual (TAU)|The control condition is defined as 'treatment as usual'. In Zambia, there are no formal services or standard of care treatments for mental and behavioral health problems among AYA. There are, however, organizations (such as non-governmental organizations) operating in Lusaka that provide intermittent services for these types of problems. Some AYA receive informal counseling from parish priests or other leaders in their communities. In this study we are therefore defining these types of informal services as 'treatment-as-usual.' We will closely track the type, number, and degree of these kinds of services that all participants receive and access. Following the conclusion of the study, we will offer the CETA intervention to control participants if it has been found to be safe and effective
15925101|NCT03458026|Other|Connected object use combined with SMS (text messages) of physical activity reminders|Watch connected used and receipt of SMS (text messages)
15925102|NCT03458026|Other|Without connected object|Any intervention except follow-up visit
15925103|NCT03458013|Behavioral|Mindfulness Meditation|Guided using an mp3 player and noise cancelling headphones, participants will be led through a series of mindfulness meditations lasting approximately 20 minutes each.
15925104|NCT03458000|Device|PillCam UGI|An esophageal capsule endoscope which is designed to visualize the upper gastrointestinal tract.
15925105|NCT03457974|Other|saliva|salivary secretion rate, salivary buffering capacity, pH, protein levels, superoxide dismutase (SOD), ferric reducing antioxidant power (FRAP), the thiobarbituric acid reactive substances (TBARS), protein carbonyl, protein thiols, total sialic acid.
15925106|NCT03457961|Drug|Perampanel|This study collects clinical information during the first 16 weeks after the first dose of AMPA/NMDA receptor antagonist. Subjects or caregivers shall provide seizure diary which documents seizure type and seizure frequency as per usual medical care. The final visit will be based on the week-16 visit.
15925107|NCT03457948|Procedure|Arterial Embolization|Undergo TAE
15925108|NCT03457948|Biological|Pembrolizumab|Given IV
15925109|NCT03457948|Biological|Peptide Receptor Radionuclide Therapy (PRRT) using 177Lu-DOTA0-Tyr3-Octreotate|Given IV
15925110|NCT03457948|Device|Yttrium-90 Microsphere Radioembolization|Undergo yttrium-90 microsphere RE
15925111|NCT03457935|Other|blood samples|Blood samples
15925112|NCT03457909|Device|DS-MCE|During the DS-MCE examination,the capsule is allowed to travel down into gastric cardia,from where the string is slowly pulled to allow the capsule to view the esophagus retrogradely.
15925113|NCT03457896|Drug|Trastuzumab|Patients with HER2 amplified tumors with prior anti-EGFR therapy and/or HER2 mutated colorectal cancer with/or without prior anti-EGFR therapy will receive 4 mg/kg IV loading dose; then 2 mg/kg IV weekly until disease progression. Neratinib: 240 mg taken by mouth daily until disease progression.
15925114|NCT03457896|Drug|Cetuximab|Patients with HER2 WT or HER2 amplified with no prior anti-EGFR therapy: 400 mg/m2 IV loading dose; then 250 mg/m2 IV weekly. Neratinib 240 mg taken by mouth daily until disease progression.
15925115|NCT03457896|Drug|Neratinib|240 mg taken by mouth daily until disease progression.
15925116|NCT03457896|Diagnostic Test|Guardant360 Diagnostic Test|Prior to assignment to Arm 1, the Guardant360 diagnostic test will be conducted in blood to confirm known HER2 status for select patients.
15925117|NCT03457883|Device|herniamesh|Patients were randomly assigned in a ratio of 1:1,by using SPSS19.0 statistical software, to either trocar-guided transvaginal mesh(herniamesh, group A) or biological graft (cook, group B)repair.
15925118|NCT03457883|Device|biological graft|Patients were randomly assigned in a ratio of 1:1,by using SPSS19.0 statistical software, to either trocar-guided transvaginal mesh(herniamesh, group A) or biological graft (cook, group B)repair.
15925119|NCT03457870|Behavioral|Intermittent Energy Restriction|Dietary advice to follow a 5:2 diet.
15925120|NCT03457870|Behavioral|Chewing|Asked to chew 1 piece of gum for 10 minutes 3 times a day.
15925121|NCT03457870|Behavioral|Chewing + Intermittent Energy Restriction|Dietary advice to follow a 5:2 diet. Asked to chew 1 piece of gum for 10 minutes 3 times a day.
15925122|NCT03457857|Other|Cleanser|Cosmetic Baby Cleanser/Shampoo
15925123|NCT03457857|Other|Cleanser and Lotion|Cosmetic Baby Cleanser/Shampoo and Baby Lotion
15925124|NCT03457844|Drug|Anlotinib|Anlotinib is followed Day 1 to day 14 by 7 days off treatment in a 21-day cycle） and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
15925125|NCT03457818|Drug|Denosumab 60 mg/ml [Prolia]|Denosumab 60 mg will be administered subcutaneously in the upper arm at the Baseline and 6 Month Visits
15925126|NCT03457818|Other|Placebo|Placebo will be administered subcutaneously in the upper arm at the Baseline and 6 Month Visits
15925127|NCT03457805|Device|Prostatic Artery Embolization|PAE is performed under local anesthesia using commercially available and approved microspheres (study is not limited to a specific manufacturer or product).
15925128|NCT03457792|Drug|Abatacept|Subcutaneous (SC) or intravenous (IV) administration
15925129|NCT03457779|Dietary Supplement|Glucose|"The first 4 patients enrolled on trial will undergo the research core biopsies of their TNBC without the 13C glucose infusion; these samples will serve as control tissue that will be processed identically to the tissues obtained from patients who received the glucose isotope.
~The following 12 patients will receive 6 grams (g) of [1,2-13C] glucose as an IV"
15925130|NCT03457766|Device|HIFU|Ultrasound (Esaota MyLabSeven) imaging system using (SL2325) probe with (6-19 MHz) frequency
15925131|NCT03457753|Drug|Riluzole Oral Soluble Film|Riluzole Oral Soluble Film (ROSF) containing Riluzole 50mg .
15925132|NCT03457740|Dietary Supplement|Formula 1|Dietary supplement for strength, testosterone, sexual function, quality of life
15925133|NCT03457740|Dietary Supplement|Formula 2|Dietary supplement for strength, testosterone, sexual function, quality of life
15925134|NCT03457740|Dietary Supplement|Placebo|Placebo comparison
15925135|NCT03457727|Drug|Danirixin|Danirixin is being developed as a potential anti-inflammatory agent for the treatment of chronic obstructive pulmonary disorder (COPD) and other inflammatory diseases and influenza. Danirixin reference (600 mg) or test formulation (475 or 600 mg or 600 mg with 5 percent HPMC) immediate release tablets will be administered by oral route in a cross-over manner.
15925136|NCT03457727|Drug|Omeprazole|Omeprazole is used as an antacid. OMP 40 mg delayed-release capsule will be administered by oral route to randomized subjects.
15925524|NCT03454503|Drug|Imatinib|Film coated tablet contains 400 mg imatinib (as mesilate)
15925142|NCT03457701|Drug|Ferrous sulfate containing the stable iron isotope (58Fe)|58Fe will be available in oral solution. An oral solution will be administered containing 3 mg of 58Fe as ferrous sulfate with 7 mg of 56Fe as ferrous sulfate (natural abundance Fe).
15925143|NCT03457688|Dietary Supplement|prebiotic inulin-type fructans|
15925144|NCT03457688|Dietary Supplement|placebo maltodextrin|
15925145|NCT03457675|Device|Activa PC+S DBS implant for OCD|"DBS system consists of the Activa PC+S Neurostimulation System:
~Model 37604 Activa PC+S Neurostimulator Model 37087 DBS Extension Model 37441 Patient Programmer Model 8181 Sensing Programmer Model 8180 Sensing Programmer Software Nexus D2/D3 System Nexus D2/D3 Application Programming Interface (API) Dow Corning Medical Adhesive, Medtronic Part #080118 Model 3387/3389 DBS Leads Model 37022 External Neurostimulator Model 8840 N'Vision Clinician Programmer Model 8870 Application Card Model 37642 Patient Programmer Model 37092 Patient Programmer Antenna"
15925146|NCT03457675|Other|One Month Blinded Discontinuation Period|"The subject and Independent Evaluators are blinded to timing of discontinuation. In all cases, the sequence will be as follows in one-week segments: 100% Active, 50% Active, Sham and Sham. Subjects will be seen weekly. Amplitude will be reduced by 50% at start of week 2 and turned off at start of week 3. Subjects will be told that DBS will be discontinued at some point during the 4 weeks. The purpose of the 50% initial reduction is to minimize rebound effects. The programmer (not the PI in this case) will be open to the design and perform sham activation as described previously. Relapse is defined as a 25% increase of the Y-BOCS over two consecutive visits compared to discontinuation baseline."
15925147|NCT03457662|Combination Product|OMC and pseudo-SDT|OMC is established according to the 2016 ACC-AHA Guidelines for the Management of Patients with PAD. Pseudo-SDT combines saline injection and obstructed ultrasound exposure on targeted lesions to simulate real SDT progression.
15925148|NCT03457662|Combination Product|OMC and SDT|OMC is established according to the 2016 ACC-AHA Guidelines for the Management of Patients with PAD. SDT treatment is the combination of sonosensitizer administration and target atherosclerotic lesions ultrasound exposure. Sinoporphyrin sodium (DVDMS) as sonosensitizer, is dissolved in 0.9% sodium solution for following skin test and intravenous injection. 0.01mg/ml DVDMS solution (0.1ml) is prepared for skin test followed by 0.04 mg/ml.DVDMS solution intravenous injection (0.2mg/kg). The target atherosclerotic lesions are marked on the corresponding skin with ultrasound guidance and underwent ultrasound exposure after 4 hours incubation. The therapeutic ultrasonic transducer is fixed to the marked skin site of each lesion.
15925149|NCT03457649|Biological|ARGX-113|
15925150|NCT03457649|Biological|Placebo|
15925151|NCT03457636|Drug|Doxycycline Anhydrous 40 MG|One Oracea Capsule (40 mg) should be taken once daily in the morning on an empty stomach, preferably at least one hour prior to or two hours after meals
15925152|NCT03457636|Drug|Adapalene/Benzoyl Peroxide Gel 0.3-2.5%|Epiduo Forte should be applied in a thin layer to affected areas of the face and/or trunk once daily after washing, with care taken to avoid the eyes, lips, and mucous membranes
15925153|NCT03457623|Other|Innovative Supported|addition of connected tools and stronger accompaniment to improve quality of life
15925154|NCT03457610|Behavioral|Speech and language intervention|Speech therapy includes education about cough and vocal hygiene, teaching strategies to reduce cough, breathing and vocal exercises. The whole therapy consists of eight sessions once a week.
15925155|NCT03457597|Drug|Midazolam hydrochloride|Midazolam hydrochloride 2.5 mg
15925156|NCT03457597|Drug|Metoprolol tartrate|Metoprolol tartrate 100 mg
15925157|NCT03457597|Drug|Pioglitazone hydrochloride|Pioglitazone hydrochloride 15 mg
15925158|NCT03457597|Drug|Tolbutamide|Tolbutamide 500 mg
15925159|NCT03457597|Drug|Omeprazole|Omeprazole 20 mg
15925160|NCT03457597|Drug|Relacorilant|Relacorilant 350mg
15925161|NCT03457584|Procedure|air arm|epiretinal membranes are excised during membrane peeling and air-tamponade is left in the eye
15925162|NCT03457584|Procedure|BSS arm|epiretinal membranes are excised during membrane Peeling and BSS is left in the eye
15925163|NCT03457545|Behavioral|Home-based pulmonary rehabilitation|Pilot study of a home-based pulmonary rehabilitation study for lung transplant candidates at the University of California San Francisco
15925164|NCT03457545|Other|Aidcube|Participants will be testing and giving feedback on the use of the Aidcube platform in being able to deliver their home-exercise prescription
15925165|NCT03457532|Drug|Glumetinib for tablet|25mg; 50mg; 100mg; 200mg; 400mg; 600mg BID or QD(Decided by SMC accroding to the safty and PK data)
15925166|NCT03457519|Device|Children's Automated Respiration Monitor (ChARM)|The Philips CHARM (children's automatic respiratory monitor) is specifically designed to detect pneumonia in low resource areas. The lightweight measuring device sits on a child's or infant's chest, secured by a strap and measures respiration rate (fast breathing) through an ingenious algorithm. In this study ChARM will be used as a self monitoring and teaching aide by the CHWS.
15925167|NCT03457506|Diagnostic Test|Digital PET/CT scan|The digital PET/CT scan will be acquired before or after the conventional PET/CT scan.
15925168|NCT03457493|Drug|DPA-714-PET/MRI|DPA-714-PET/MRI
15925169|NCT03457480|Other|Computer-Assisted Intervention|Read computer messages
15925170|NCT03457480|Behavioral|Focus Group|Attend focus group
15925171|NCT03457480|Other|Informational Intervention|Receive text messages
15925172|NCT03457480|Other|Survey Administration|Complete surveys about experience
15925173|NCT03457467|Drug|Apatinib|Apatinib 500 mg is administered orally daily, until disease progression or untolerable toxicity
15925174|NCT03457467|Radiation|SBRT|according to the different treatment sites given the corresponding dose: 1200cGy × 4 times or 800cGy × 7 times, or according to the specific situation dose adjustment
15925175|NCT03457454|Other|Primary Care Provider/Staff Participants Interview|-Approximately a 30 minute interview
15925176|NCT03457454|Other|Patient Participant Interview|-Approximately 45-60 minute interview
15925177|NCT03457454|Other|Patient Participant Anonymous Survey|-Survey completion will take approximately 15 minutes
15925178|NCT03457454|Other|Colonoscopy Provider/Staff Participants Interviews|-Approximately a 30 minute interview
15925179|NCT03457441|Other|Standards vision tests|Subjects vision : near visual acuity, contrast sensitivity and scotoma and metamorphopsia detection will be assessed by gold-standard tests and with the OdySight medical application
15925580|NCT03454048|Drug|Sulfadoxine pyrimethamine|Curative regimen (1000mg/50mg)
15925180|NCT03457441|Device|OdySight medical application assessment|Subjects vision : near visual acuity, contrast sensitivity and scotoma and metamorphopsia detection will be assessed by gold-standard tests and with the OdySight medical application
15925181|NCT03457402|Behavioral|Shaping Delay Tolerance|Participants will be introduced to an adaptive tablet-based application that asks the child to choose between two options: 1) a shorter duration of game play that begins immediately, or 2) a longer duration of game play that begins after a delay. Depending on the child's choices, the application alters the pre-reward delay with the intent of training the child to tolerate longer delays for larger rewards (i.e., more game play). Children may participate in up to 25 approximately 30-minute training sessions over 3-6 weeks.
15925182|NCT03457389|Drug|Cabergoline|Cabergoline tablet
15925183|NCT03457376|Diagnostic Test|Hand Grip Force|Hand Grip Force
15925184|NCT03457376|Diagnostic Test|Maximal Inspiratory Pressure|Maximal Inspiratory Pressure
15925185|NCT03457376|Diagnostic Test|Maximal Expiratory Pressure|Maximal Expiratory Pressure
15925186|NCT03457363|Device|DTM will be add above NC|After oxygenation by classical nasal cannula, the DTM will be place above NC
15925187|NCT03457350|Procedure|cervical negotiation|trial to bypass severe cervical stenosis
15925188|NCT03457337|Drug|S-1 plus Gefitinib|S-1: According to the body surface area (BSA) to determine the dose, twice daily, after breakfast and dinner orally Gefitinib: 250mg, 1 day, orally, fasting or with the same service
15925189|NCT03457337|Drug|Gefitinib|Gefitinib: 250mg, 1 day, orally
15925190|NCT03457324|Drug|JCM-16021|This prescription with seven ingredients.
15925191|NCT03457324|Drug|Placebo|Placebo
15925192|NCT03457311|Drug|G.S.P. Oral Solution 400 mg/ml|Oral 1.25 ml/kg BW G.S.P. oral solution after fasting for 6 hours.
15925193|NCT03457298|Device|Ossix Volumax|Ossix Volumax is intended to be used for Lateral ridge augmentation
15925194|NCT03457298|Device|FDBA with collagen membrane|freeze-dried bone allograft (FDBA) with collagen membrane
15925195|NCT03457285|Other|Physiotherapy|"Participants, with a confirmed diagnosis of AS, will be invited to participate. Once participants have provided informed consent, they will be required to complete the outcome measures provided. Participants will be set up to use the online exercise application and educated on its use.
~Participants will then have access to videos of suitable exercises or exercise classes to follow and education material on their condition to read. Participants will be able to complete AS specific outcome measures and record their progress. Participants will also have a monthly video call with the senior rheumatology physiotherapist to discuss their exercise programme, symptoms and management. The participants will also record their compliance with their exercise programmes.
~After the 6 month pilot period, participants will be required to complete the same outcome measures completed at the start of the study."
15925196|NCT03457272|Other|New risk assessment|"Consists of a simple physiological scoring system and an assessment of patients who should assist healthcare professionals in identifying patients at risk of clinical deterioration earlier and support timely response and escalation of observation, care and treatment and thereby prevent the development of severe clinical deterioration.
~The patients included in the study will be monitored using the new risk assessment tool with different intervals according to the patients' conditions. Underlying the tool are algorithms of action for intervention in the critically ill patient, inter professional guidelines and guidance for standardized monitoring, escalation plans and huddles."
15925197|NCT03457259|Device|PVC and/or PICCline|Pt. will receive PVC and/or PICCline
15925198|NCT03457259|Device|Midline|Pt. will receive midline
15925199|NCT03457246|Other|D-Pigment rich texture|
15925200|NCT03457246|Other|Hydrance optimale riche|
15925201|NCT03457233|Drug|Gonadotropins|1) Gonadotrophines is started on day 2 with HMG(merional, IBSA) ,until the day of HCG administration
15925202|NCT03457233|Drug|GNRH antagonist|cetrorelix 0,25mg s.c is given using flexible protocol, it is given when at least one follicle reaches size 14 mm to prevent premature lutenization ,until the day of hCG administration
15925203|NCT03457233|Drug|Human chorionic gonadotropin Chorimon|10000 IU of HCG are given intramuscular when 2 or more mature follicles reach 18 - 20 mm
15925204|NCT03457233|Drug|Natural progesterone|400 mg vaginal tablets twice daily from the day of ovum pick up till HCG tesing
15925205|NCT03457207|Procedure|Combined minilaparotomy- laparoscopy approach|Laparoscopic aspiration of cyst then guided its extracorporeal cystectomy then reposition and evaluation by laproscopy
15925206|NCT03457194|Biological|Quadrivalent Influenza Vaccine|Inactivated quadrivalent influenza vaccine that is used for active immunisation against influenza A, B virus strains (contained in vaccine). Single dose administration by intramuscular injection to all enrolled pregnant women as part of routine antenatal care.
15925207|NCT03457194|Biological|DTP Vaccine (Multiple Actives)|Pertussis vaccine acellular combined with diphtheria and tetanus toxoids. Single dose administration by intramuscular injection, to all enrolled pregnant women who are 28 weeks or greater gestation at time of enrolment, as part of routine antenatal care.
15925208|NCT03457181|Other|music|effect of music on anxiety scores
15925209|NCT03457181|Other|operating room noise|effect of operating room noise on anxiety scores
15925210|NCT03457168|Procedure|Treatment of elevated asleep SBP mean|To reduce asleep SBP mean determined by 48h ambulatory blood pressure monitoring up to the randomly assigned target by hypertension treatment intensification when required
15925211|NCT03457155|Other|VS-I dosing in plasma samples|"VS-I dosing in plasma samples using ELISA protocol :
~At intensive care admission time
~24h after admission time
~In case of FA occurrence
~In case of sinusal rhythm recovery (in patients with new onset FA)"
15925212|NCT03457142|Biological|Abatacept|Given IV and SC
15925213|NCT03457142|Drug|Dexamethasone|Given PO
15925214|NCT03457142|Drug|Ixazomib Citrate|Given PO
15925215|NCT03457142|Other|Laboratory Biomarker Analysis|Correlative studies
15925216|NCT03457129|Drug|Perampanel Oral Tablet|Perampanel is an AMPA receptor blockade, that has shown to be efficacious for seizure reduction in both partial onset seizures and generalized tonic-clonic seizures. Perampanel was approved by the FDA in October 2012 as adjunctive treatment in patients with partial onset seizures. Additionally, in June 2015, Fycompa was approved as adjunctive therapy in patients with primary generalized tonic clonic seizures.
15925217|NCT03457116|Drug|Norco|20 tablets of Hydrocodone 5mg-Acetaminophen 325mg (Norco)
15925218|NCT03457116|Drug|NSAID|Ibuprofen 400mg for post-operative pain
15925220|NCT03457103|Device|Pulmonary Rehabilitation (PR)|Patients in both treatment groups will participate in a 10 week (16-20 sessions) comprehensive PR program. The control group will receive the 10-Week PR program with traditional breathing training sessions (without biofeedback). The program comprises 2 or 3 exercise training sessions per week by physical therapists (each 1 hour duration).
15925221|NCT03457090|Other|Examination : a TCD and Trans-Thoracic Echocardiography|"Examination that involves the completion of a TCD and an TTE (Trans-Thoracic Echocardiography) :
~To reports clinical parameters at the time of the examination : ECG data: sinus rhythm, atrial or ventricular arrhythmia, state of consciousness, heart rate, O2 saturation
~To review of pharmacological parameters at the time of the examination : presence of sedation; presence, type and dose of catecholamines.
~To collect biological data from the day of the examination : Partial Pressure of O2, PaCO2 (partial pressure) and hematocrit
~To collect possible additional examinations : brain scan, EEG. These are non-invasive exams that do not require patient displacement. Only the samples taken by the medical team as part of the treatment will be analyzed."
15925222|NCT03457077|Behavioral|Brief intervention|A brief motivational intervention with feedback about drinking levels compared to norms
15925223|NCT03457064|Behavioral|PA+Social Adherence Intervention(PASAI)|While both physical activity programs were tailored to match participants' physical needs and abilities, the PA+Social Adherence Intervention(PASAI) introduced elements to promote and strengthen self-efficacy and social interaction among participants.
15925224|NCT03457051|Procedure|Total Knee Arthroplasty (TKA)|In total (complete) knee arthroplasty (TKA), the orthopaedic surgeon removes the damaged areas of the knee and replaces the components with an artificial joint. The device that will be used is: Stryker TKA Triathlon system implant Cruciate retaining radius femur design. This device has been approved for use by Health Canada.
15925225|NCT03457051|Procedure|Unicompartmental Knee Arthroplasty (UKA)|Unicompartment (partial) knee arthroplasty (UKA) has been available for over 40 years and differs from TKA in that only the most affected and symptomatic compartment (most commonly medial, but occasionally lateral and patella femoral) are replaced. The device that will be used is: Stryker PKR implant cemented and fixed bearing design. This device has been approved for use by Health Canada.
15925226|NCT03457038|Biological|Blood Test|"Addition to the current care but during the normal follow-up visit :
~At the entrance to the service: search for bacterial 16S RNA in the blood
~Additional blood tests (4) at T6-12-18 and 36h
~At each visit: Sampling of an additional heparinized blood tube for the assay PAMPs.
~1 time per day: Assay of CRP and PCT from samples taken in common practice
~J30: Assessment of the vital status of the patient"
15925227|NCT03457025|Drug|Oral Corticosteroids|Prednisone 10 day taper: 60mg for 5 days, then taper for five days to 0mg
15925228|NCT03457025|Drug|Oral antivirals|acyclovir 400mg: one pill 4 times daily for 7 days
15925229|NCT03457025|Device|Hyperbaric Oxygen Therapy|2.4atm administered for twice daily dives for 5 days, 10 dives total. To be begun in the first 1 week after onset of paralysis.
15925230|NCT03457012|Drug|Semaglutide|Patients will be treated with commercially available semaglutide in a prefilled pen injector (FlexTouch® variant) according to routine local clinical practice at the discretion of the treating physician. Other anti-hyperglycaemic treatments will be prescribed at the physician's discretion.
15925231|NCT03456999|Biological|MAU868|MAU868 infused i.v. over 1 hour. One dose will be administered monthly for a total of 6 doses.
15925232|NCT03456999|Biological|Placebo|Solution containing no active excipients, infused i.v. over 1 hour. One dose will be administered monthly for a total of 6 doses
15925233|NCT03456986|Behavioral|PATH neurotraining|Tunes up the center of the motion discrimination (dorsal stream) working range
15925234|NCT03456986|Behavioral|Orientation Discrimination|Tunes up the ventral stream most sensitive to high contrast and colored patterns.
15925235|NCT03456973|Behavioral|Nurse AMIE|Supportive care software platform
15925236|NCT03456960|Drug|TAK-438ASA|TAK-438ASA tablet.
15925237|NCT03456960|Drug|TAK-438|TAK-438 tablet.
15925238|NCT03456960|Drug|Aspirin|Aspirin enteric-coated tablet.
15925239|NCT03456947|Drug|Pregabalin|the patients receive 150mg or 300mg pregabalin 60 minutes prior to the surgery
15925240|NCT03456934|Other|Modified infant formula|Test formula with lower protein content than standard formula
15925241|NCT03456934|Other|Standard infant formula|Standard infant formula
15925242|NCT03456921|Other|"End-of-life conversation game called Hello"|To play 'Hello', players are provided 32 open-ended questions in a prearranged order and an equal number of game chips. A player reads aloud the first question. Players then individually write down their answers, and take turns sharing answers with the group (players can opt to pass). Players control how long they share, what they share, and when they are ready to proceed to the next question. During the conversation, players may choose to acknowledge others for a particularly thoughtful, poignant, or even funny comment by giving them a chip. A simple pre-game coin flip determines whether the player with the most chips 'wins' the game ('heads'), or the player with the least amount of chips wins the game ('tails').
15925243|NCT03456908|Combination Product|18F-TFB-PET|Infusion of F-18 TFB and PET / CT imaging
15925244|NCT03456895|Other|Light perception|We will be using Wi-Fi/IP programmable LED lighting systems that will replace conventional lighting systems and may be in canned lights, spot lights, light chains or table lights. These lighting systems can be fully controlled by web based applications on smart phones tablets and computer systems and can be combined with input systems such as switches, motion detection or voice activated. Differences in lighting perception will be explored by varying lighting color and brightness.
15925245|NCT03456895|Other|Sound perception|We will be using Wi-Fi/Bluetooth addressable sound systems that will be linked with sound sources such as media players on smart devices or computer systems. Differences in sound perception will be explored by varying sound types (i.e. different music types, ambient noise, etc.).
15925246|NCT03456895|Other|Smell perception|We will explore the use of consumer grade ventilation systems that can be equipped to distribute packaged scents. Differences in smell perception will be explored by varying the types of scents.
15925247|NCT03456895|Other|Vibration perception|We will explore the use of chairs or blankets that enable subjects to perceive vibrations. An initial implementation will be the use of on relaxing/massage chair that enables the experience of vibration sensation in the back or leg area. We may use also potentially vibration blankets in the arm or neck area. Differences in vibration perception will be explored by varying the location, frequency, etc. of vibrations with the subject being placed in a chair on an imaging table/bed.
15925248|NCT03456895|Other|Voice activation|We will explore the use and linkage of voice activation system such as Amazon Echo, Google home or similar devices. Some participants may be asked to use voice activations to verbally select and/or change the environmental settings according to their preferences. We are evaluating the feasibility of voice activation with the imaging environment.
15925249|NCT03456882|Drug|RNS60|normal saline plus oxigen in nanobubble
15925250|NCT03456869|Device|Patient Specific Implant|The patient specific implant is used to simultaneously complete the reposition and fixation of the chin.
15925252|NCT03456843|Drug|Antiandrogen Therapy|To demonstrate at least 30% improvement in FFS at 2 years after randomization with the power of 90% and error of 5% on a one-sided exponential MLE test.
15925253|NCT03456843|Drug|Docetaxel|To demonstrate at least 30% improvement in FFS at 2 years after randomization with the power of 90% and error of 5% on a one-sided exponential MLE test.
15925254|NCT03456843|Other|Laboratory Biomarker Analysis|Correlative studies
15925255|NCT03456843|Procedure|Quality-of-Life Assessment|Ancillary studies
15925256|NCT03456843|Other|Questionnaire Administration|Ancillary studies
15925257|NCT03456843|Procedure|Radical Prostatectomy|Undergo cytoreductive radical prostatectomy
15925258|NCT03456830|Drug|ALLN-177|ALLN-177 7,500 units (2 capsules), orally, with each meal/snack, 3 to 5 times per day for 28 days
15925259|NCT03456830|Drug|Placebo|Placebo 2 capsules, orally, with each meal/snack, 3 to 5 times per day for 28 days
15925262|NCT03456804|Drug|ESK981|Treatment with ESK981 for patients with metastatic castrate resistant prostate cancer
15925263|NCT03456791|Diagnostic Test|Human epididymis protein 4|Human epididymis protein will be quantitatively assayed using the enzyme immunometric assay (EIA) method
15925265|NCT03456765|Diagnostic Test|Ultrasound|US will be made to assess kidneys
15925266|NCT03456752|Drug|Dexamethasone|Dexamethasone 8mg intravenously prior to induction of anesthesia
15925267|NCT03456752|Drug|Normal saline|Normal saline 1.6ml intravenously prior to induction of anesthesia
15925268|NCT03456726|Drug|Tazemetostat|Tazemetostat will be provided as a 200 mg oral tablet.
15925269|NCT03456713|Biological|LY3074828|Administered SC
15925270|NCT03456700|Drug|Auranofin|Given PO
15925271|NCT03456700|Other|Laboratory Biomarker Analysis|Correlative studies
15925272|NCT03456700|Drug|Sirolimus|Given PO
15925273|NCT03456687|Drug|Exenatide|Exenatide will be administered through a subcutaneous injection once per week for the duration of the study (1 year).
15925274|NCT03456674|Device|LaseMD System|A non-invasive fractional thulium laser delivering a wavelength of light energy as a fractionated array of microbeams to be absorbed by and damage the target molecule, a chromophore.
15925275|NCT03456661|Drug|Levobupivacaine|Infiltration with 0.25% 29,5ml + 0,5ml physiologic serum (total volume 30ml), US guided, using pectoralis block technique.
15925276|NCT03456661|Drug|Levobupivacaine + Dexmedetomidine|Infiltration with chirocaine 0.25% 29,5ml + 0,5ml dexmedetomidine (50µg) (total volume 30ml), US guided, using pectoralis block technique.
15925277|NCT03456648|Drug|apixaban|non-vitamin K oral anticoagulant (NOAC)
15925278|NCT03456635|Other|guided antimicrobial prophylaxis|During the intervention period, antimicrobial prophylaxis decisions will be guided by a computerized program
15925279|NCT03456609|Drug|shenqifuzheng injection|500ml shenqifuzheng daily（at day 1-14 and day22-36）through intravenous infusion.
15925280|NCT03456609|Drug|Sodium Chloride Injection 0.9%|500ml sodium chloride（0.9%）daily（at day 1-14 and day22-36）through intravenous infusion.
15925281|NCT03456596|Other|ENABLE|This is an implementation science study in which an evidence-based early palliative care intervention, ENABLE (Educate, Nurture, Advise, Before Life Ends), is being implemented in rural community cancer centers that did not have a palliative care program.
15925384|NCT03455699|Device|ClosureFast Radiofrequency Ablation (RFA)|Radiofrequency thermal ablation of the GSV using the Covidien ClosureFast system.
15925282|NCT03456583|Device|Brevera Breast Biopsy System|The Brevera Breast Biopsy System with CorLumina imaging technology is a vacuum-assisted biopsy device, which is used to remove breast tissue in a minimally invasive manner using stereotactic or tomosynthesis imaging. A breast biopsy is a test that removes tissue or sometimes fluid from the suspicious area. The removed cells are examined under a microscope and further tested to check for the presence of breast cancer. A biopsy is a diagnostic procedure that can definitely determine if the suspicious area is cancerous.
15925283|NCT03456570|Drug|Dydrogesterone 10 mg|Dydrogesterone 10 mg twice daily
15925284|NCT03456570|Drug|Placebo Oral Tablet|oral tablets twice daily
15925285|NCT03456557|Radiation|Perfusion computed tomography.|Using specific post treatment imaging software ( Olea® ) we will calculatell permeability parameters : the pancreatic blood flow and the k-trans, capillary membrane permeability factor.
15925286|NCT03456544|Drug|Vancomycin|Patients who have vancomycin associated acute kidney injury will be in the Van-AKI group, and those who don't have vancomycin associated acute kidney injury will be in the none VAN-AKI group.
15925287|NCT03456531|Device|pulsed radiofrequency|The patient will have pulsed radiofrequency to suprascapular nerve for 6 minutes
15925288|NCT03456531|Drug|"NSAIDs ibubrofen,Aspirin"|"medical treatment as NSAIDs ibubrofen,Aspirin"
15925289|NCT03456505|Behavioral|Mindfulness Meditation Training|A researcher will guide participants through 5 mindfulness meditations, each lasting 11 minutes in length.
15925290|NCT03456505|Behavioral|Active Listening|A researcher will read participants 5 selections from The Natural History of Selborne, each lasting 11 minutes in length.
15925291|NCT03456492|Diagnostic Test|serum sodium|Serum sodium will be measured on admission, assesment of mental status by Modified Mini-Mental score and measurement of glutamate in CSF sample taken while dripling during spinal anathesia for surgical intervention.
15925292|NCT03456479|Diagnostic Test|skin prick test - specific serum IgE|The study will assess the diagnosis of Cow's milk protein allergy (CMPA) among infant and children in Assiut University Children Hospital using skin prick test and specificserumIgE
15925293|NCT03456466|Drug|TQB2303|375mg/m2 ，iv
15925294|NCT03456466|Drug|Rituximab|375mg/m2 ，iv
15925295|NCT03456453|Behavioral|NIDA Standard for HIV Prevention|The NIDA Standard is a manualized, HIV prevention education intervention focused on reducing risky sexual and drug use practices. It will be adapted for Facebook in this pilot trial.
15925296|NCT03456440|Diagnostic Test|MRI|MRI scan of the patients liver with DWI and acquisition of ADC value.
15925297|NCT03456427|Device|Patient-Assisted Compression (PAC)|The technologist will properly position the breast and apply minimum compression. The subject will be instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image will be acquired. This will be done for both standard views Craniocaudal (CC) & Mediolateral Oblique (MLO).
15925298|NCT03456427|Device|Technologist-Controlled (TC) Compression|TC compression will be conducted per standard of care practices at the site.
15925299|NCT03456414|Other|Virtual reality exercise during hemodialysis|Subjects will play a virtual reality game specially adapted for subjects undertaking hemodialysis treatment
15925300|NCT03456401|Drug|Sorafenib or Sunitinib|After two lines of TKIs, patients received a third line with sunitinib or sorafenib, according to previous treatments
15925301|NCT03456388|Drug|Ammoxetine Hydrochloride Enteric-coated Tablets|There will be 7 ascending cohorts. The first cohort will be administered 2.5 mg once. The second cohort will be administered 7.5 mg. The third cohort will be administered 15 mg once. The forth cohort will be administered 30 mg once. The fifth cohort will be administered 45 mg once. The sixth cohort will be administered 65 mg once.The seventh cohort will be administered 100 mg once. The results of each dose group were shown to be safe and tolerable, and then the next dose group was tested.
15925302|NCT03456388|Drug|placebo enteric-coated tablets|There will be 7 ascending cohorts. The first cohort will be administered 2.5 mg once. The second cohort will be administered 7.5 mg. The third cohort will be administered 15 mg once. The forth cohort will be administered 30 mg once. The fifth cohort will be administered 45 mg once. The sixth cohort will be administered 65 mg once.The seventh cohort will be administered 100 mg once. The results of each dose group were shown to be safe and tolerable, and then the next dose group was tested.
15925303|NCT03456362|Device|REPETITIVE TRANSCRANIAL MAGNETIC STIMULATION|theta burst stimulation (TBS) is a novel form of repetitive transcranial magnetic stimulation that mimics protocols inducing long-term potentiation (LTP) or long-term depression (LTD) in animal models. Whereas continuous TBS (cTBS) induces long-lasting inhibition of cortical areas, iTBS exerts the opposite effect, increasing cerebellar excitability
15925304|NCT03456349|Drug|HTL0018318|HTL0018318
15925305|NCT03456349|Drug|Placebo|Placebo
15925306|NCT03456336|Other|Active Treatment|Infants assigned to the active treatment group will receive indomethacin or ibuprofen per their local site usual care dosing and schedule if the infant has a sPDA. The choice of indomethacin or ibuprofen will be left to the center, however, infants may only receive one or the other. If the infant receives both, it will be considered a protocol violation.
15925307|NCT03456336|Other|Expectant Management|Infants assigned to the expectant management group will receive indomethacin or ibuprofen if cardiopulmonary compromise occurs.
15925308|NCT03456323|Behavioral|Palliative Care Consultation|The palliative care consultation team will be led by one of the board-certified palliative care physicians at Columbia University Medical Center. Over one or more visits, the palliative care consultation team will first review intervention participants' medical records and baseline Edmonton Symptom Assessment System (ESAS) scores. They will also directly assess participants' physical and psychological symptoms. They will provide supportive counseling, make treatment recommendations for burdensome symptoms to the primary team of physicians, and will address goals of care. They will document these activities in structured electronic medical record consultation notes.
15925309|NCT03456323|Other|Usual Care|Patient-surrogate pairs randomized to usual care will not have a palliative care consultation intervention offered, and will receive care by their primary physicians. However, if a palliative care consultation is requested after randomization to usual care by the primary team of physicians and/or the patient/surrogate, it will be provided.
15925385|NCT03455699|Device|Roll-In (VenaSeal SCS)|Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.
15925310|NCT03456310|Diagnostic Test|transperineal ultrasound|"trans-perineal US: B mode capable 2D ultrasound system with cine loop function, a 3.5-6.0 MHz curved array transducer. A mid-sagittal and axial views is obtained by placing a transducer on the perineum (Parting of the labia can improve image quality).
~Dynamic MRI:
~Magnetic resonance (MR) imaging of the pelvic floor is a two-step process that includes:
~analysis of anatomic damage on axial fast spin-echo (FSE) T2-weighted images. then sagittal and coronal (FSE) T2-weighted are obtained.
~functional evaluation using sagittal dynamic single-shot T2-weighted sequences during straining and defecation."
15925311|NCT03456297|Other|Web-based clinical pedagogy program (WCP)|The nurse preceptors in the experimental cluster will be given access to download the WCP on mobile devices. The unique interactive features provide continuous support and allow preceptors to discuss the clinical encounters with their peers and consult experts for advice.
15925312|NCT03456284|Device|Normothermic Liver perfusion|The liver grafts will be preserved and evaluated at physiological temperature and have continuous perfusion with oxygen and nutrient supply in the ex vivo organ preservation phase
15925313|NCT03456258|Diagnostic Test|Complete blood count|To measure hemoglobin difference and serum ferritin levels .
15925314|NCT03456245|Device|Vision device validation|Group members had their vision tested with the following devices/methods: Eyenetra NETRA, PlenOptika Quicksee, Right Manufacturing Retinomax K Plus 3, and standard eyesight tests using eye charts, phoropters, and slit lens lamp imaging.
15925315|NCT03456232|Other|High-flux hemodialysis|High-flux hemodialysis using diffusion, ultrafiltration and convection principle to remove harmful substances in the blood and excessive water.
15925316|NCT03456232|Other|Hemodiafiltration|Hemodiafiltration is a combination of hemodialysis and hemofiltration with two modes of treatment advantages, both by diffusion and convection principle to remove harmful substances in the blood.
15925317|NCT03456219|Other|Normal protein diet|The intervention with the control diet was composed of 65% of carbohydrates, 15% of proteins and 20% of lipids.
15925318|NCT03456219|Other|High-protein diet|The intervention with the higher-protein diet was composed of 45% of carbohydrates, 35% of proteins and 20% of lipids.
15925319|NCT03456206|Other|Intake of red and processed meat and fibres|The intention is to analyse exposure groups in tertiles: 1) Upper tertile (33.3% of the total sample) based on the ratio: meat/fibre intake is associated with higher risk of CID. 2) Low intake of fibre (defined as below the lower tertile [33.3% of the total sample]) and high intake of red and processed meat (defined as those above the upper tertile [33.3% of the total sample]) are independently associated with higher risk of CID, and their synergy (interaction between the factors meat and fibres) gives the highest risk outcome.
15925320|NCT03456206|Other|Lifestyle factors independently or combined|Lifestyles factors are defined as: red and processed meat, vegetables, dietary fibre, cereals, gluten, legumes, red wine, dairy products, physical activity, smoking, total protein/fat, protein/fat from red and processed meat, glycemic index.
15925321|NCT03456193|Procedure|LA transplant|"The proposed study treatment will include three central components:
~Harvest of the left atrium and pulmonary veins from a suitable donor
~Excision of the left atrium and portions of stenotic pulmonary veins from the patient with pulmonary vein stenosis
~Implantation of the donor posterior left atrium and portions of pulmonary veins into the patient."
15925322|NCT03456180|Device|Haemoadsorption with Cytosorb cartridge|microcirculatory monitoring in septic shock patients requiring renal replacement therapy for acute renal failure and haemoadsorption with Cytosorb cartridge
15925323|NCT03456167|Other|RecoverWell mobile app for follow-up care|The mobile app follow-up care is an application that can be loaded onto a smartphone. It allows the patient to submit photos of their surgical site, QoR15 scores, and EORTC selected adverse events scores. The information collected is transmitted to members of the surgical team (i.e. the primary surgeon) and used to monitor recovery over the first 6 weeks following surgery.
15925324|NCT03456154|Drug|Botox Injectable Product|60u will be used at 3 sites of masseter muscle, on each side of the face
15925325|NCT03456154|Device|Occlusal splint|In this group patients will receive an occlusal splint which will be worn everyday for 6 months at night.
15925326|NCT03456141|Procedure|third molar surgery|The patient is asked to complete the diary each post-surgery day for 14 days. Recovery is organized into three QOL domains: lifestyle, oral function, and pain.
15925327|NCT03456128|Other|CAPABLE|It involves up to 10 in-home tailored interventions of approximately 60 minutes duration each over a 5-month period. The assessment driven interventions are delivered by an Occupational Therapist (OT) (≤ 6 home visits for ≤ 1hour), a Registered Nurse (RN) (≤ 4 home visits for ≤ 1hour), and a handyman (HM) team.
15925328|NCT03456115|Device|Mechanical nasal dilator|Participants will be asked to trial 5 different mechanical nasal dilators. 4 of which are commercially available and one of which is the investigational device being studied for feasibility. The 4 commercially available nasal dilators include Breathe Right, Max Air, Sleep Right, Nozovent. The fifth device is the study team's investigational device dubbed the Schnozzle.
15925329|NCT03456102|Drug|Pravastatin|"Phase IIB clinical trial: A two-week safety/PK study to determine pravastatin exposures over 24 hours when given together with first-line treatment (HRZE) and ensure the combination is safe and well-tolerated.
~A two-week safety/PK study to determine pravastatin exposures over 24 hours when given together with first-line treatment (HRZE) and ensure the combination is safe and well-tolerated."
15925330|NCT03456089|Diagnostic Test|Urodynamics Testing|Urodynamics utilizes a small catheter to fill the bladder and continuously measure pressure and volume giving information on bladder function and compliance
15925337|NCT03456063|Drug|Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody|"Atezolizumab will be administered as intravenous (IV) infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle (every 3 weeks) for 4 cycles during the neoadjuvant treatment phase
~Atezolizumab will be administered as IV infusion at a dose of 1200 milligrams (mg) every 3 weeks for 16 cycles during the post-operative adjuvant phase"
15925338|NCT03456063|Drug|Placebo Comparator|Placebo will be administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase
15925339|NCT03456063|Drug|Nab-paclitaxel|Nab-paclitaxel 100 mg/m^2 will be administered intravenously on Days 1, 8, and 15 of each 21 day cycle for 4 cycles during the neoadjuvant treatment phase
15925340|NCT03456063|Drug|Pemetrexed|Pemetrexed 500 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase
15925341|NCT03456063|Drug|Carboplatin|Carboplatin initial target AUC of 6 mg/mL/min will be administered intravenously on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase
15925342|NCT03456063|Drug|Cisplatin|Cisplatin 75 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase
15925343|NCT03456063|Drug|Gemcitabine|Gemcitabine 1250 mg/m^2 will be administered intravenously on Day 1 and 8 of each 21-day cycle for 4 cycles during the neoadjuvant treatment phase
15925344|NCT03456050|Behavioral|FRC exercise|The program will consist of hip joint controlled articular rotations (CARs) in standing position for 3 - 5 repetitions. Then, the participant will sit on the floor in what is called 90/90 position which is sitting in hip and flexion in 90 degrees for both the lead (front) and trail (side) leg. The participant will perform a Progressive and regressive angular isometric loadings (PAILs and RAILs) for the trail leg to increase the range of internal rotation, the contraction will be performed three times and the holding of the position will be for two minutes. After expanding the range, the participant will perform Progressive and regressive angular loadings (PALs and RALs) isometric contractions in form of a passive range hold for internal rotation and abduction, for 3 - 5 times.
15925345|NCT03456050|Behavioral|Conventional Exercise|The conventional training program in this study will be the routine training for increasing the hip rotation. By screening the scientific literature, the conventional training found to consists of static stretching and strengthening using body weight and/or a band and the time of holding a stretch is about 30 seconds. For that the flexibility exercise will consist of progressive stretching from a prone position (leg fall in a stretch), the participant will perform 3 - 5 repetitions with 30 seconds hold or as tolerated. The strengthening exercise consists of hip abduction (hip opening) using a band or ankle weight from side lying for 10 - 12 repetitions 3 times.
15925346|NCT03456037|Other|hepatitis viruses|There are 5 main hepatitis viruses, referred to as types A, B, C, D and E. These 5 types are of greatest concern because of the burden of illness and death they cause and the potential for outbreaks and epidemic spread. In particular, types B and C lead to chronic disease in hundreds of millions of people and, together, are the most common cause of liver cirrhosis and cancer.The aim is to investigate incidence of HBsAg, anti-HCV in serum samples and evaluation of biomarkers taken from patients who were followed the intensive care unit of Sakarya University Training and Research Hospital.
15925347|NCT03456024|Other|Questinnaire|
15925348|NCT03456011|Other|Battlefield Acupuncture|Battlefield Acupuncture gold semi permanent needles
15925349|NCT03455998|Other|questionnaires|
15925350|NCT03455985|Other|Discharge Order Set (DOS)|In addition to the elements in ESC, for the DOS group the primary team will be contacted to complete the Diabetes Discharge order set, which will be pre-populated into the electronic discharge navigator. Follow-up phone calls in the DOS group will also assess and reinforce insulin dose self-titration.
15925351|NCT03455985|Other|Enhanced Standard Care (ESC)|Patients in the ESC group will receive hospital discharge instructions using current best practices within the overall functionality of the electronic medical record, which facilitates medication reconciliation and use of a patient care resource manager. Phone calls are information gathering only in the ESC group, and questions related to care will be referred to the usual provider.
15925352|NCT03455972|Biological|anti-CD19 and anti-BCMA CAR|Participants will get auto-HSCT. Hematopoietic reconstitution after auto-HSCT, participants will get the anti-CD19 CAR T cells (1×10e+7/kg on d0) and anti-BCMA CAR T cells as split-dose (total 5×10e+7/kg, 40% on d1 and 60% on d2)
15925353|NCT03455972|Drug|Immunomodulatory drugs|Maintenance therapy
15925354|NCT03455959|Procedure|Bronchoscopy/BAL|Participants will receive 2-3 inhalations(90 ug ea)of albuterol to minimize bronchoconstriction.Medication includes midazolam by intravenous injection, and fentanyl by intravenous injection as judged necessary.4% lidocaine is delivered via atomizer spray to the oral pharynx for local anesthesia.1% lidocaine is delivered through the bronchoscope to the vocal cords and lung segments for local anesthesia.The bronchoscope is then passed through the vocal cords into the trachea.Throughout the procedure,all participants will have continuous blood pressure,heart rate,and oxygen saturation monitoring.Participants will be instructed to relate any discomfort or problems through a series of standardized hand signals.Once in the lung, aliquots of sterile saline are instilled into a subsegment of the lingula of the left lung and withdrawn into a trap by gentle suction. Then,the bronchoscope is passed into a subsegment of the right upper lobe and the right middle lobe where the lavage is repeated.
15925355|NCT03455959|Procedure|Airway Brushing|After completion of the BALs, endobronchial brushing of the airways will be performed using the airway brushings with a Conmed Harrell™ 4 mm unsheathed cytology brush. Upon completing the brushing the investigators remove the bronchoscope with the brush in place to avoid shearing off isolated cells. The brush will be gently glided back and forth on the airway epithelium 10 times in 2 different locations within the same airway. The brush is then placed in media and flicked to remove the cells. There is some airway bleeding caused by the procedure, and participants are made aware that they may cough up small amounts of blood for 24-48 hours following the procedure.
15925386|NCT03455686|Other|Hyperpolarized 129Xe MRI|Magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas is a research approach for the non-invasive visualization and measurement of lung structure and function.
15925356|NCT03455946|Behavioral|DASH cloud with Alexa|"Participants will download and install the Alexa and Nutritionix application (app) onto their smartphone and study staff will setup the study-specific account to send data to Duke's software system called Prompt. Participants will be instructed to invoke through voice their dietary intake daily for three months using the Nutritionix app through the Amazon Alexa personal assistant. DASH Cloud will access participant's dietary intake data through the Nutritionix application programing interface (API) for three months. Participants' data will automatically be uploaded from the Nutritionix app via the API that links the device with DASH Cloud. DASH Cloud will run an algorithm and send a daily or weekly feedback text message with a score reflecting DASH adherence for the prior days or week's food consumption using a previously validated scoring system."
15925357|NCT03455933|Other|Sham Comparator|The investigators will apply a light intensity shockwave in the lateral epicondyle with the portable SHOCKMASTER 300 at a 8Hz frequency and 2000 impulses. The intensity will be regulated to reach a 3/10 in the VAS scale, depending on the tolerance of the subject. Each patient will receive between 5 and 10 impulses starting with the lower intensity of the device (middle energy: 1 bar) and will go up towards the target (3/10 in VAS).
15925358|NCT03455933|Other|Experimental Intervention|The investigators will apply a moderate intensity shockwave in the lateral epicondyle with the portable SHOCKMASTER 300 at a 8Hz frequency and 2000 impulses. The intensity will be regulated to reach a 6/10 in the VAS scale, depending on the tolerance of the subject. Each patient will receive between 5 and 10 impulses starting with the lower intensity of the device (middle energy: 1 bar) and will go up towards the target (6/10 in VAS).
15925359|NCT03455933|Other|Control Group|Patients will place their hand, wide open and up to the wrist, into the inner part of the container and will keep it under water for a maximum time of 2 minutes. If pain is unbearable before the time ends, the participant will be able to withdraw the hand.
15925360|NCT03455920|Other|Clinical nurse (supernurse) evaluation|The first evaluation of the patient refered to the sleep clinic will be performed by the clinical nurse then discussed with the pulmonologist in charge.
15925361|NCT03455920|Other|Pulmonologist evaluation|The first evaluation of the patient refered to the sleep clinic will be performed only by the pulmonologist.
15925362|NCT03455894|Device|DETECT'CHUTE CLINIBED|The DETECT'CHUTE carpets will be positioned at night at the foot of the bed and set in motion by the nursing staff as soon as the elderly person goes to bed for the night. They will be withdrawn the next morning after the resident's rise. Each patient will benefit from the mat for 1 month.
15925363|NCT03455868|Procedure|Bariatric surgery|Sleeve gastrectomy or Roux-in-Y gastric bypass
15925364|NCT03455855|Device|Jetstream System|including Atherectomy Console (Jetstream Console) and Atherectomy Catheter(Jetstream Catheter), intended for use in atherectomy of the peripheral vasculature and to break apart and remove atherosclerotic disease, debris, and thrombus from the SFA and/or PPA.
15925365|NCT03455842|Biological|BCD-089, 162 mg, s/c, qw|Subcutaneous injections of anti-IL6R every week
15925366|NCT03455842|Biological|BCD-089, 162 mg, s/c, q2w|Subcutaneous injections of anti-IL6R every other week
15925367|NCT03455842|Drug|placebo|Subcutaneous injections of placebo every week, until week 12. Thereafter subcutaneous injections of anti-IL6R every other week
15925368|NCT03455829|Drug|G1T38|CDK 4/6 inhibitor
15925369|NCT03455829|Drug|Osimertinib|EGFR TKI; 80 mg
15925370|NCT03455816|Device|Social Diabetes App|"Social diabetes is an app for diabetes, free with CE mark, that by means of the incorporation of a glucometer (glucomen Areo) allows through NFC technology the automatic introduction of data in the application"
15925371|NCT03455816|Device|Usual clinical monitoring group (Control group)|Active Comparator: Usual clinical monitoring group (control group) This group does not use the App. This group have an intermediate visit at 3 months with de doctor to see blood glucose self-monitoring and propose adjustments
15925372|NCT03455803|Device|CPAP|Continuous positive airway pressure
15925373|NCT03455790|Diagnostic Test|Aerobic Capacity|"Upper limb muscle strength assessments of the athletes will be performed with the ISOMED 2000® isokinetic device and the grip strength with the Jamar® dynamometer. The aerobic capacity values will be measured using the Cosmed K5® instrument and the TS in the Cosmos-Saturn brand running band. Anaerobic capacity will be measured by Wingate anaerobic power test (WanT) for 30 seconds in standard laboratory conditions for TS basketball athletes using Monark 894 E model ergometer developed by Monark for upper extremity anaerobic capacity and power measurement. The sporty performances will be evaluated with the 20 m Sprint test, Slalom Test and Zone Shot tests."
15925374|NCT03455777|Drug|AKCEA-ANGPTL3-LRX|Single open-label cohort
15925375|NCT03455764|Drug|MCS110|MCS110 is a colony-stimulating factor-1 (CSF-1) inhibitor. It is a human monoclonal antibody which binds CSF-1.
15925376|NCT03455764|Drug|Dabrafenib|Dabrafenib attack different proteins that promote the growth of cancerous cells
15925377|NCT03455764|Drug|Trametinib|Trametinib attack different proteins that promote the growth of cancerous cells
15925378|NCT03455751|Genetic|PGx-guided post-operative pain management|Post-operative pain management as indicated by pharmacogenomic testing results.
15925379|NCT03455738|Other|vasoplegic syndrome|Patients with vasoplegic syndrome for whom the intensive care physician planned to decrease the norepinephrine dosage were included. Hemodynamic and uncalibrated pulse contour analysis (Volume view, FloTrac, Edwards Lifescience, Irvine) values were obtained before and after decreasing the norepineprhine dosage. Responders were defined by a >10% decrease in mean arterial pressure (MAP).
15925380|NCT03455725|Device|CardiAMP Cell Therapy System|The CardiAMP Cell Therapy system consists of the CardiAMP Potency Assay, the Helix/Morph intramyocardial delivery catheter system, and the CardiAMP Cell Separator. The system allows the investigator to identify patients with a high chance to respond to im autologous stem cell therapy (using the CardiAMP Cell Potency Assay), to isolate the stem cells from a bone marrow harvest at the point of care (using the CardiAMP CS system), and to percutaneously inject the autologous cells into the myocardium using the Helix/Morph delivery catheters.
15925381|NCT03455725|Other|Sham Treatment|Patients will receive sham bone marrow procedure and a ventriculogram. A scripted sham percutaneous procedure will be performed
15925382|NCT03455712|Behavioral|Gestational Weight Gain Card|The Gestational Weight Gain Card is designed to be an educational and weight gain tracking tool. Study subjects will be highly encouraged to use the GWG card to gain both important clinical information and to document weight measurements throughout their pregnancy.
15925387|NCT03455673|Diagnostic Test|ATE score|"The Atrial Thrombus Exclusion (ATE) combine thromboembolic risk factors (hypertension, cardiac insufficiency, history of stoke) and d-dimer level for the prediction of intra-atrial thrombus :
~Hypertension = 1 Heart failure = 1 History of stroke = 1 High plasma d-dimer level (> 270 ng/ml) = 1"
15925388|NCT03455660|Other|no intervention|no intervention
15925389|NCT03455647|Behavioral|ASF promotion plus Girinka|Behavior change communication promoting the consumption of milk produced in the household and other optimal maternal and child nutrition practices. The intervention will be implemented by government of Rwanda Community Health Workers.
15925390|NCT03455634|Device|Twin Block|functional appliances for the stimulation of the mandibular growth
15925391|NCT03455634|Device|Sander bite jumping appliance|functional appliances for the stimulation of the mandibular growth
15925392|NCT03455621|Procedure|Toothbrushing|Toothbrushing with different amounts of fluoride toothpaste (or a non-fluoride toothpaste as a control)
15925393|NCT03455608|Behavioral|RE-ACTIVE|Reactive intervention started promptly if/when dysphagia is identified
15925394|NCT03455608|Behavioral|PRO-ACTIVE EAT|Early low intensity proactive intervention started before RT commences
15925395|NCT03455608|Behavioral|PRO-ACTIVE EAT + EXERCISE|Early high intensity proactive intervention started before RT commences
15925396|NCT03455595|Procedure|Endoscopic exams|Coloscopy
15925397|NCT03455582|Other|Clinical assessment|Expanded Disability Status Scale (EDSS), ambulation test and Multiple Sclerosis functional composite (MSFC). Medications will be recorded.
15925398|NCT03455582|Other|Ecological evaluation|Virtual reality task and Actual reality
15925399|NCT03455582|Other|Neuropsychological evaluation|cognitive tests exploring information processing speed, attention/concentration, working and episodic memories and executive function
15925400|NCT03455582|Other|Psychological evaluation|questionnaires for depression, anxiety and fatigue
15925401|NCT03455582|Device|MRI Evaluation|morphological MRI and resting state functional MRI (fMRI)
15925402|NCT03455569|Behavioral|Behavioral sleep education|This group will receive manual-based sleep hygiene recommendations and a behavioral sleep intervention including sleep compression therapy
15925403|NCT03455569|Behavioral|Education only|This group will receive information about sleep, aging, and dementia, but without specific or individualized recommendations
15925404|NCT03455556|Biological|Anetumab Ravtansine|Given IV
15925405|NCT03455556|Biological|Atezolizumab|Given IV
15925406|NCT03455556|Other|Laboratory Biomarker Analysis|Correlative studies
15925407|NCT03455543|Device|Active Provant Therapy System|Treatment with active Provant Therapy System
15925408|NCT03455543|Device|Inactive (sham) Provant Therapy System|Treatment with inactive Provant Therapy System
15925409|NCT03455530|Other|Industrial Hygiene-Enhance Community Health Worker Intervention|The intervention will be derived from audits and exposure assessments and focus groups with workers and owners in the same business types (excluded from the trial) conducted in an earlier part of the study, as well as a community advisory group (e.g., Hispanic Chamber of Commerce) . From this, we will generate educational materials specific for each small business sector. We will provide the CHWs with a list of industry-specific control options along with potential cost savings and benefits. For example, EPA estimates a cost saving of $13,000 per year for auto body shops that switch to the high-velocity low-pressure spray guns. Each list will be a comprehensive menu of options that contain multiple control measures including simple controls, such as keeping the lids on the solvent containers.
15925410|NCT03455517|Drug|Venetoclax|Venetoclax and rituximab association
15925411|NCT03455517|Drug|Rituximab|Venetoclax and rituximab association
15925412|NCT03455504|Drug|Venetoclax|Venetoclax add in combination with fludarabine, cyratabine and idarubicine
15925413|NCT03455491|Drug|XC221 100 mg|once daily during 3 days.
15925414|NCT03455491|Drug|XC221 200 mg|once daily during 3 days.
15925415|NCT03455491|Drug|Placebo|once daily during 3 days.
15925416|NCT03455478|Device|spectacles|dispending spectacles for uncorrected refractive error
15925417|NCT03455465|Other|Community Health Worker Assessment|Participants will be approached by a community health worker who will ask them to complete an assessment of needs and offer to enroll them in post-discharge services to help address the needs identified.
15925418|NCT03455439|Drug|Rivaroxaban (Xarelto, BAY59-7939)|As prescribed by the treating physician
15925419|NCT03455426|Drug|letrozole|Women will be randomizedfor ovarian stimulation with letrozole or to natural cycle IUI.
15925420|NCT03455413|Device|Swisstom BB2 EIT device|Swisstom BB2 EIT device and NeoSensor Belts will be used to assess lung aeration, ventilation distribution and strech during invasive ventilation in perioperative care.
15925421|NCT03455400|Device|Swisstom BB2 EIT device|Swisstom BB2 EIT device with NEO SensorBelts will be used to measure ventilation distribution during spontaneous breathing and position changes in healthy newborn infants.
15925422|NCT03455387|Diagnostic Test|sampling of the serum marker sFlt1 and PlGF|sampling of the serum markers sFlt1 and PlGF , every 3 days,until delivery
15925423|NCT03455374|Device|Treatment with CSI atherectomy device|Following peripheral angiography, patients with significant SFA or below the knee artery disease (≥ 50%) or total occlusions (100%) will have a baseline OCT imaging of the target vessel and the lesion be treated with proper size CSI burr. Repeat OCT imaging will be performed after CSI. Drug eluting balloon angioplasty may be performed in discretion of the operator. If DEB is used, a final OCT imaging will be performed to assess lesion expansion and possible dissections. Balloon sizing will be based on 1:1 vessel ratio with the length covering from minimally diseased distal segment to minimally diseased proximal segment. We will try to avoid use of stents.
15925424|NCT03455361|Procedure|Stark Implant with low primary stability|
15925425|NCT03455348|Other|catheter insertion|catheter insertion one to less than 4 four centimeters to the wrist joint (Group A) and the other, to more than four centimeters to the wrist joint. (Group B)
15925426|NCT03455335|Drug|20 million hMSCs|
15925427|NCT03455335|Drug|40 million hMSCs|
15925428|NCT03455335|Drug|80 million hMSCs|
15925458|NCT03455075|Drug|Dimethandrolone-Undecanoate|Single doses of DMAU in castor oil/benzyl benzoate administered in 100 mg capsules.
15925459|NCT03455075|Drug|Levonorgestrel 0.03 MG|Single doses of LNG administered in 30 mcg capsules.
15958585|NCT03198624|Drug|Placebo oral capsule|Part B only
15925429|NCT03455322|Drug|norepinephrine versus midodrine & octreotide|either intravenous infusion (IVi) norepinephrine in a dose of 0.05-0.3ug/Kg/min. to keep mean arterial pressure ≥ 80-100mmHg & continued either until HRS reversal or for maximum 10 days or oral midodrine 5mg three times/day & can be increased every 24h up to 12.5mg three times daily plus octreotide 100ug/ 6h subcutaneous & if needed increased to 200ug/6h.
15925430|NCT03455309|Biological|NDV-3A|Single dose administered by intramuscular injection
15925431|NCT03455309|Biological|Placebo|Single dose administered by intramuscular injection
15925432|NCT03455296|Other|fluid therapy; crystalloid|maintenance fluid e.g. Ringer or Ringer acetate plus replacement fluid with crystalloids e.g. Ringer,or Ringer acetate or saline 0.9%, 500ml / 30 min. guided by ScVO2 with target value ≥ 70% versus lactate clearance (LCR) with target value ≤ 2mmol/L (or decline ≥ 10%) by the end of the study in group A & group B respectively. Maintenance fluid without replacement will be initiated if ScVO2 or lactate value normalized.
15925433|NCT03455283|Drug|Clariscan|Clariscan 0.5 mmol/ml solution for injection will be administered as part of clinical practice according to the judgment of the site with regard to medical need.
15925434|NCT03455283|Other|Gadolinium-Based Contrast Agents|All GBCAs will be selected by the sites and recorded as by the brand names.
15925435|NCT03455270|Drug|G1T48|oral SERD
15925436|NCT03455270|Drug|Palbociclib|CDK 4/6 Inhibitor
15925437|NCT03455257|Behavioral|Cash Transfer|The heads of households will receive a cash transfer for up to 7 family members in the home every quarter. Head of households will be expected to attend meetings every 4 months at their local community health centers led by Community Health Workers (CHW). Meetings will have 2 components: 1) children under 5 will be measured to identify children at risk of malnutrition and 2) group education sessions. There will also be monthly growth monitoring and education sessions led by CHW for a subgroup of head of households with children identified as risk of malnutrition with rapid referrals to regional tertiary clinics for any children with health problems that cannot be addressed by CHW.
15925438|NCT03455244|Device|FFRangio|"FFRangio is a non-invasive image-based software device that provides physicians with a quantitative analysis of functional significance of the coronary lesion, similar to invasive FFR (Fractional Flow Reserve), and a qualitative three-dimensional model of the demonstrated coronary arteries, during routine PCI procedure. The CathWorks FFRangio software device is able to perform all required processing and calculations, based only on angiography images and hemodynamics information that are acquired during the coronary catheterization procedure.
~The CathWorks FFRangioTM technology does not require any additional use of invasive devices, or any additional vasodilation treatment, as required by other known FFR techniques."
15925439|NCT03455231|Radiation|Short course radiotherapy|An accelerated hypo-fractionation radiotherapy is delivered for palliation in patients with complicated bone metastases
15925440|NCT03455218|Drug|Nitric Oxide|20 ppm of Nitric Oxide gas delivered to the oxygenator for the duration of cardiopulmonary bypass
15925441|NCT03455218|Drug|Placebo|INOmax device connected to oxygenator, but no gas is delivered
15925442|NCT03455218|Device|INOmax|All patients will have the INOmax device connected to the oxygenator
15925443|NCT03455205|Drug|shenqifuzheng|500ml shenqifuzheng daily（at day 1-7and day22-28）through intravenous infusion.
15925444|NCT03455205|Drug|0.9%sodium chloride|500ml sodium chloride（0.9%）daily（at day 1-7 and day22-28）through intravenous infusion.
15925445|NCT03455192|Drug|Synbiotic Supplement|
15925446|NCT03455192|Drug|Placebo Oral Tablet|
15925447|NCT03455179|Other|Slow-speed traditional resistance training|The training session will consist in a general warm-up, 6 resistance exercises, including 2 upper limb exercises (elbow curl and chest press), 2 lower limb exercises (lunge and standing hip abduction), and 2 exercises combining both upper and lower limbs at the same time (squat plus upright rowing and squat plus shoulder press) and finally the cooldown routine.The participants will perform in each training session 6 submaximal repetitions equivalent to 85% of the one-repetition maximum (1RM) and 3-4 sets per exercise (high intensity training sessions).
15925448|NCT03455179|Other|High-speed resistance training|The participants will perform the same exercises than the TRADICIONAL group with12 submaximal repetitions equivalent to 40-50% 1RM (low-intensity) and 3-4 sets per exercise.
15925449|NCT03455179|Other|Multicomponent training|Participants will perform, in this order, balance exercises followed by resistance/coordination, aerobic/coordination and flexibility exercises in each session. The balance training will consist in static, dynamic and proactive balance exercises. In the resistance training block, the participants will perform 3-4 sets of 15 submaximal repetitions Participants will perform 2 resistance exercises (squat plus upright rowing and lunge) at traditional slow-speed (2s of concentric contraction and 2s of eccentric contraction).The intensity of the aerobic block will progress from 65 to 85% of the maximum heart rate over the training weeks.
15925450|NCT03455166|Diagnostic Test|Serum Markers|Serum Markers
15925451|NCT03455153|Other|Physical activity monitoring|COPD patients will wear an accelerometer and complete questionnaires related to daily physical activity levels for 7 days before returning for a clinic visit.
15925452|NCT03455140|Drug|PEG- BCT-100|PEGylated recombinant human arginase 1
15925453|NCT03455127|Other|FSI ECD|Households will be visited by a trained community based lay worker on a weekly to biweekly basis to deliver the 15 module curriculum covering a range of topics from nutrition, water and sanitation, hygiene, early stimulation, conflict management, to good communication. The intervention seeks to promote healthy child development via active coaching to individual beneficiary households, delivering modules on a one on one basis and engaging all family members.
15925454|NCT03455114|Device|AssiAnchor|"The novel device, the capsular Anchor, was designed to secure the capsular bag to the scleral wall. The device is a one-piece, one-plane intraocular implant . It works like a paper clip; holding the anterior capsule between a central rod, placed in front of the capsule, and the two lateral arms, inserted through the eye surgery and placed behind the capsule."
15925455|NCT03455101|Other|There is no intervention.|There is no intervention.
15925456|NCT03455088|Behavioral|Dialectical Behavioral Group Therapy|DBT is based on the model for the development of emotion regulation, designed for teaching how to regulate their adaptive emotions and behaviors cased by mood disorders , so it is valid for BN patient.
15925457|NCT03455088|Drug|Drug: fluoxetine|Antidepressant fluoxetine can reduce binge eating and purging behaviors in BN patients in a short time.
15958659|NCT03198026|Drug|Ibrutinib|Given PO
15925461|NCT03455062|Other|Questionnaire about fertility|"Recruitment of participants through the list of cardiac, renal, hepatic, pancreatic or pulmonary transplant patients collected from the the Organ Transplant Unit.
~A letter from the the Organ Transplant Unit will initially be sent to patients informing them of the study and if they do not wish to participate they can report their opposition by email.
~A fertility questionnaire will be send and that will have to be returned by the patient in order to be included in the study.
~The questionnaires, anonymous, will be numbered according to their order of return."
15925462|NCT03455049|Other|Andrographis Paniculata Ext|Give the Androgaphis paniculata in prediabetes and normal subject for 14 days.
15925463|NCT03455036|Other|Whole body vibration training|10 x 1 min whole body vibration exposure
15925464|NCT03455023|Other|pharmaceutical care|Patients receive pharmaceutical care including individualized evaluation and intervention of adherence, efficacy and safety in cancer pain treatment.
15925465|NCT03455010|Other|Increased load|Participants walk with 120% body weight achieved with a weight vest
15925466|NCT03455010|Other|Reduced load|Participants walk with 80% body weight achieved by a dynamic unloading system
15925467|NCT03454997|Other|training including in-person and online|training, motivational interviewing practice
15925468|NCT03454997|Other|organizational strategy meetings|meetings with leadership to optimize implementation of evidence-based practices
15925469|NCT03454997|Other|performance coaching|to enhance ability to deliver the weight management intervention
15925470|NCT03454984|Drug|Guadecitabine|30/m2/day SubCutaneous for 5 days (Cycle = 28 days). total of 10 cycles
15925471|NCT03454971|Other|MinOS protocol|"At Day 1, Cycle 1 and 2 of the patient's oral therapy :
~Consultation with a hospital pharmacist
~Consultation with a nurse care coordinator
~Consultation with the patient's oncologist/hematologist
~During this multidisciplinary consultation, will be reviewed :
~potential medical interactions,
~possible adverse effects of therapy,
~information on the prescribed drug,
~informations on the patient's lifestyle, ...
~At day 8 and 15, cycle 1 and 2 :
~Phone call from the nurse care coordinator during which will be reported the adverse effects and adherence issues. If needed, the nurse care coordinator can provide complementary information about the treatment.
~The MINOS protocol follow up will end with a consultation with the patient's oncologist/hematologist, at day 1 cycle 3."
15925472|NCT03454958|Other|Measurements of body composition|Body weight (SECA digital weighing scale), height (SECA stadiometer), body composition (TANITA Bioelectrical Impedance Analyzer & skin fold thickness measurements at the biceps, triceps, subscapular and suprailiac sites) and waist circumference (Cescorf measuring tape) will be objectively measured.
15925473|NCT03454945|Drug|Vibramycin|Antibiotic
15925474|NCT03454945|Device|Phototherapy|UVA+Psoralen
15925475|NCT03454932|Other|Blood sampling|
15925476|NCT03454919|Drug|Palbociclib|"Drug: palbociclib; ibrance; Pfizer Inc，New York，NY Schedule: Recommended initial dosage 125mg/d，3 weeks on, 1 week off. If grade 3 or 4 adverse events occur during treatment，dosage could be reduced to 100mg/d, even 75mg/d.
~Duration: till disease progression or drug intolerance."
15925477|NCT03454893|Drug|AVR-RD-01|AVR-RD-01 Drug Product (autologous CD34+ cell-enriched fraction that contains cells transduced with Lentiviral Vector/alpha-galactosidase A (AGA) encoding for the human AGA complementary deoxyribonucleic acid (cDNA) sequence
15925478|NCT03454867|Device|Hemofiltration|
15925479|NCT03454867|Procedure|Standard acute ischemic stroke treatment|
15925480|NCT03454854|Device|intelligent terminal APP|Applications(APP) support patients to upload the primary data contain pictures and wearable devices data. When risk-rating changes or serious adverse events(SAE) take place, APP will alert patients to seek medical advice or make a call with the doctor. Beside, terminal of patients furnishes functions like answering frequently asked questions,self-assessment of physical condition,push rehabilitation knowledge etc.
15925481|NCT03454841|Drug|Prasugrel|Patients with myocardial infarction will receive a 60 mg prasugrel loading dose, followed by a maintenance dose of 10 mg once daily
15925482|NCT03454841|Drug|Ticagrelor|Patients with myocardial infarction will receive a 180 mg ticagrelor loading dose, followed by a maintenance dose of 90 mg twice daily
15925483|NCT03454828|Dietary Supplement|obese carbohydrate diet|The experimental diet will consist of 30% carbohydrates (CHO), 35% protein, and 35% fat. Since the experimental diet is lower in CHO, the fiber and sugar content will be calculated based on total CHO in the same percentage as the control (0.25 g fiber per each kcal of CHO and 18.2% sugar for total CHO).
15925484|NCT03454828|Dietary Supplement|lean carbohydrate diet|The control diet composition will follow the American Dietary Guidelines of 55% carbohydrates (CHO), 15% protein, and 30% fat. CHO content will be primarily complex CHO of high quality (14 g fiber/1,000 kcals and <10% of total kcals in the form of sugar).
15925485|NCT03454815|Procedure|Apical patency|Apical patency was maintained by passing a #10 K file 1 mm beyond working length between every instrument change while doing chemomechanical preparation
15925486|NCT03454802|Diagnostic Test|Passive Leg Raising|See above
15925487|NCT03454789|Drug|brachial plexus block for LB Group|Standardized UG AX-SC approach to the BP was performed under sterile conditions by the same anesthesiologist. SC block was performed with the traditional in-plane, single injection cluster approach, then AX approach was performed in the supine position, with a standardized dose of 0.4 ml/kg BW
15925488|NCT03454789|Drug|brachial plexus block for BS Group|Standardized UG AX-SC approach to the BP was performed under sterile conditions by the same anesthesiologist. SC block was performed with the traditional in-plane, single injection cluster approach, then AX approach was performed in the supine position, with a standardized dose of 0.4 ml/kg BW
15925489|NCT03454789|Drug|brachial plexus block for LS Group|Standardized UG AX-SC approach to the BP was performed under sterile conditions by the same anesthesiologist. SC block was performed with the traditional in-plane, single injection cluster approach, then AX approach was performed in the supine position, with a standardized dose of 0.4 ml/kg BW
15925490|NCT03454789|Drug|brachial plexus block for BL Group|Standardized UG AX-SC approach to the BP was performed under sterile conditions by the same anesthesiologist. SC block was performed with the traditional in-plane, single injection cluster approach, then AX approach was performed in the supine position, with a standardized dose of 0.4 ml/kg BW
15925491|NCT03454776|Device|Unloader One brace|A knee brace used to unload affected compartments in osteoarthritic knees
15925581|NCT03454048|Drug|Atovaquone Proguanil|Curative regimen (1000/400 mg, for 3 days)
15925492|NCT03454776|Device|Placebo brace|A knee brace that feels and looks like Unloader One but without active straps facilitating unloading of the knee
15925493|NCT03454763|Drug|PRRT every 5 weeks|PRRT (radiolabelled somatostatin analogues) every 5 weeks for 5 cycles
15925494|NCT03454763|Drug|PRRT every 8-10 weeks|PRRT (radiolabelled somatostatin analogues) every 8-10 weeks for 5 cycles
15925495|NCT03454750|Drug|177Lu-PSMA|177Lu-PSMA 3.7-5-5 GBq Intravenous Slowly in 15-30 ' Day 1/ every 8-12 weeks Four cycles every 8-12 weeks
15925496|NCT03454737|Procedure|mesenchymal stem cells|"Autologous bone marrow aspiration is used as a cellular source to obtain MSVs and is subjected to the protocolized anticoagulant procedure. After checking the perfect condition of the shipment and the correct completion of the documentation that accompanies it, the processing of the bone marrow will be carried out.
~The processing of the bone marrow will be done in the Cell Therapy Unit of the IBGM under NCF, within 24 hours of the completion of the aspiration"
15925497|NCT03454737|Procedure|Pure platelet-rich plasma|"Under aseptic conditions, in surgical medium, 6 ml of P-PRP will be obtained from 36 ml of autologous peripheral venous blood sample.
~The plasma coagulation will be activated by the addition of Cl2Ca at a concentration of 5%."
15925498|NCT03454724|Device|MeRes100 Sirolimus-Eluting BioResorbable Vascular Scaffold System|MeRes100 Sirolimus-Eluting BioResorbable Vascular Scaffold System used in the treatment of patients with coronary artery disease along with standard percutaneous angioplasty procedure.
15925499|NCT03454724|Device|Xience EES Everolimus Eluting Coronary Stent System|Xience EES Everolimus Eluting Coronary Stent System indicated for the treatment of coronary artery disease along with standard percutaneous angioplasty procedure.
15925500|NCT03454711|Device|fMRI|Brain MRI
15925501|NCT03454711|Device|Indirect calorimetry|Resting energy expenditure
15925502|NCT03454711|Device|Bioimpedance|Measurement of body composition
15925503|NCT03454711|Biological|Lipid profile, glucose, HBA1c, metabolomic analysis|Blood sample
15925504|NCT03454711|Behavioral|YFAS questionnaire, Binge Eating Scale, Hospital Anxiety and Depression (HAD) scale, hedonic evaluation test (liking)|Questionnaires to characterize eating habits and depression
15925505|NCT03454698|Other|Education|"Usual care as described for the CG also applies to the IG. The intervention will consist of giving patients an opportunity to learn about the use of compression bandages, wearing and putting on compression stockings, physical activity, good skin care, and a high-protein, vitamin-rich diet. This group will be supervised by a study nurse, who will not be identical with the nurse in charge of the control group."
15925506|NCT03454685|Other|without intervention type|Without intervention,this study is just an observational study.
15925507|NCT03454672|Device|Tixel|Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
15925508|NCT03454672|Device|Laser|Tixel treatment. Between 3-5 treatment sessions according to investigator's review of subject response.
15925509|NCT03454659|Procedure|Craniotomy|Extracting the part of the sculpt
15925510|NCT03454646|Drug|cholinesterase inhibitors (CI) (donepezil, galantamine or rivastigmine)|"The choice of the treatment will be done by the specialist according to his habits; the specialist will monitor the treatment as usual. All the recruited patients will be treated by CI according to the recommendations of the French HAS and the clinician's habits to choose the type of CI and adjust the dosage. After a 6-month period under CI treatment, patients will be classified according to the evolution of the Mini Mental State Examination (MMSE) as non-responders or responders.
~Responders patients will continue their treatment according to the habits of the clinician. Non-responder patients will be included in the RCT, with individual randomization in two groups: one group who stops the CI, one group who continues the CI. All randomized patients will then be followed-up for two years with regular assessment of judgment criteria every 6 months."
15925511|NCT03454633|Procedure|the temperature of hypothermic circulatory arrest|Different temperature (mild 30 degree or moderate 25 degree) employed during the hypothermic circulatory arrest on aortic surgery.
15925512|NCT03454620|Drug|irinotecan|GC1118 combination with irinotecan
15925513|NCT03454620|Drug|FOLFIRI|GC1118 combination with FOLFIRI
15925514|NCT03454607|Device|FREE robot|FREE robot to hold endoscope
15925515|NCT03454594|Device|low level laser hemotherapy|semiconductor laser therapeutic instrument irradiate the circulating blood in the vessels of left hand acupoint and the mucosal tissue in the nasal cavity
15925516|NCT03454581|Procedure|Photobiomodulation|PBM was applied, three times a week for four consecutive weeks at 5 points in the TMJ region: superior, anterior, lateral, posterior and postero inferior to the condyle. In addition, all patients received laser application in the temporal muscle (anterior, middle and posterior), in the masseter (upper, middle and lower portion) and insertion of the medial pterygoid.
15925517|NCT03454581|Procedure|Manual Therapy (MT)|Patients were submitted to MT at temporal, masseter and pterygoid medial from both sides, during 3 minutes each muscle group (Extraoral) and at masseter and lateral pterygoid (Intraoral) for 3 minutes, each total 21 minutes. MT on the TMJ region was performed for 1 minute and 3 repetitions during three times a week .
15925518|NCT03454555|Behavioral|Shared Decision Making|The Shared Decision Making (SDM) intervention is a behavioral intervention to explore and compare treatment options, assess a patient's values and preferences, and reach a shared decision. The intervention will have both clinician and patient components. The content of the clinician component will be based on the AHRQ (Agency for Healthcare Research and Quality) SHARE Approach, which is a 5-step process for shared decision making that includes exploring and comparing the benefits, harms, and risks of each option through meaningful dialogue about what matters most to the patient (Agency for Healthcare Research and Quality, 2017) . Patients randomized to Arm 1 will have their study visits and opioid use managed by an SDM-trained clinician at their practice.
15925519|NCT03454555|Behavioral|Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain|The Motivational Interviewing and Cognitive Behavioral Therapy for Chronic Pain intervention is an empirically based behavioral pain management behavioral therapy intervention (Monticone et al., 2015), including MI to enhance motivation for opioid dose reduction or cessation and CBT-CP for pain coping skills enhancement. We anticipate one MI session that will focus on engaging, focusing, evoking, and planning. We anticipate 8 sessions of CBT-CP, as is standard, delivered in a group setting.
15925520|NCT03454542|Device|Menicon Modified Lens Design|Randomized in a daily wear, single day (6 hours or more) evaluation
15925521|NCT03454529|Other|Laboratory Biomarker Analysis|Correlative studies
15925525|NCT03454490|Procedure|Postoperative pseudoaneurysm of the greater palatine artery|Patients had an autogenous connective tissue gingival graft.
15925526|NCT03454477|Procedure|conventional open surgery|conventional open surgery
15925527|NCT03454477|Procedure|endoscopic thyroidectomy|endoscopic thyroidectomy
15925528|NCT03454477|Device|robotic thyroidectomy|robotic thyroidectomy
15925529|NCT03454464|Procedure|Conventional|Conventional operation ,Thyroidectomy was performed first, and central compartment dissection was performed. This is a routine procedure
15925530|NCT03454464|Procedure|central neck dissection first|central neck dissection first ,after FNA confirmed of thyroid carcinoma, the central compartment neck dissection was carried out before thyroidectomy , finally complement of central compartment neck dissection.
15925531|NCT03454451|Drug|CPI-006|Subjects will receive escalating doses of CPI-006 administered intravenously once every 21 days until MTD is reached or until disease progression.
15925532|NCT03454451|Drug|CPI-006 + ciforadenant|Subjects will receive escalating doses of CPI-006 administered intravenously once every 21 days in combination with CPI-444 orally twice daily until MTD is reached for CPI-006 or until disease progression.
15925533|NCT03454451|Drug|CPI-006 + pembrolizumab|Subjects will receive escalating doses of CPI-006 in combination with pembrolizumab administered intravenously once every 21 days until MTD is reached for CPI-006 or until disease progression.
15925534|NCT03454451|Drug|CPI-006|Selected dose of CPI-006 administered intravenously once every 21 days until disease progression.
15925535|NCT03454451|Drug|CPI-006 + ciforadenant|Selected dose of CPI-006 administered intravenously once every 21 days, in combination with CPI-444 orally twice daily until disease progression.
15925536|NCT03454451|Drug|CPI-006 + pembrolizumab|Selected dose of CPI-006 in combination with pembrolizumab administered intravenously once every 21 days until disease progression.
15925537|NCT03454438|Procedure|Referral strategies|Two referral strategies will be compared to usual care, i.e. the control group. Patients will be followed for one year.
15925538|NCT03454425|Device|Exablate Subthalamotomy|ExAblate Subthalomotomy for the Treatment of Parkinson's Disease Motor Features
15925539|NCT03454425|Device|Sham Exablate Subthalamotomy|Sham ExAblate Subthalomotomy for the Treatment of Parkinson's Disease Motor Features
15925540|NCT03454412|Procedure|Intensive Neurophysiological Rehabilitation|Intensive Neurophysiological Rehabilitation System (INRS) is a combination of different treatment modalities that complement and reinforce each other. It includes spinal manipulative therapy, physical therapy, occupational therapy, joints mobilization techniques, special massage therapy, mechanotherapy, computer games therapy and other treatments with daily duration up to 4 hours.
15925541|NCT03454399|Procedure|Suction orogastric tube which is attached to TEE probe|Suction orogastric tube which is attached to TEE probe
15925542|NCT03454386|Behavioral|Stress Management and Resilience Training Program|"This program targets attention and interpretation of events, people and the world through the skills of gratitude, compassion, acceptance, forgiveness and understanding of a higher meaning. The program involves two phases. The 4 week training phase begins with a group session that discusses the practices that can be used to enhance awareness and engagement through the principles listed above. Participants will receive twice weekly emails with videos that described a different practice for participants to use in their daily lives. The second phase is the sustain phase that is 8 weeks in duration. Participants are expected to continue using the daily practices learned during the training phase. Weekly emails will be sent with ways to incorporate these practices into their daily lives."
15925543|NCT03454386|Behavioral|Self-Management Stress Reduction Program|Program participants will be given a popular stress reduction book to read over a 12 week period. Upon completion of this, they will be enrolled in the online SMART program for 12 weeks.
15925544|NCT03454373|Behavioral|Incentive for linkage to care|"Participants who were found to have been lost to care will receive standard of care plus a one-time re-start incentive of 22,500 TZS to return to care"
15925545|NCT03454360|Device|ACURATE neo™ Aortic Bioprosthesis|TAVI; Transcatheter Aortic Valve Replacement. Transapical Access.
15925546|NCT03454347|Dietary Supplement|Profile Perform|The dietary supplement includes 1.5 grams of fat, 19 grams of carbohydrate, and 25 grams of protein per serving. Participants in the experimental group will consume 3 servings per day.
15925547|NCT03454347|Other|Lower Limb Suspension|This group will complete two weeks of lower limb suspension.
15925548|NCT03454334|Device|multifocal intraocular lens IOLs|clinical outcome of different multifocal intraocular lenses (IOLs) in patients with presbyopia or cataracts
15925549|NCT03454321|Other|Infiltration|The subacromial injection will be performed under ultrasound guidance to accurately inject the subacromial bursae. After skin disinfection with povidone, the injection will be performed with a 21G needle. The bursae will be injected with 2 ml of lidocaine 2% and 1 ml of betamethasone.
15925550|NCT03454308|Behavioral|SMASH|Auditory and visual reminders are active on Pill device will alert subject each time their medication dose is due. Pill device will transmit dose taken time stamps to researchers. Text message the following morning with tailored motivational messages that reflect the medication dose adherence from the preceding day. Subjects will monitor their BP at home at least every third day using Bluetooth monitor linked to smartphone to transmit encrypted readings to researchers.
15925551|NCT03454308|Behavioral|Enhanced SC|Auditory and visual reminders are inactive on Pill device. Pill device will transmit dose taken times to researchers. Healthy lifestyle test messages as attention control.
15925552|NCT03454295|Behavioral|Focus Group|Participants will be asked to reflect on their caregiving experience and specifically, when the receipt of a supportive intervention that addresses existential distress would have been most appropriate and well received.
15925553|NCT03454295|Behavioral|Meaning-Centered Psychotherapy for Cancer Caregivers / MCP-C|MCP-C is structured as a 7-session (1-hour weekly or biweekly sessions) individual intervention that utilizes a mixture of didactics, discussion and experiential exercises that focus around particular themes related to meaning and cancer caregiving
15925582|NCT03454048|Other|malaria challenge infection, P. falciparum 3D7|malaria challenge infection by P. falciparum 3D7-infected mosquito bites
15925583|NCT03454048|Other|Blood stage malaria challenge infection, P. falciparum 3D7|P. falciparum 3D7-infected human erythrocytes administered intravenously for the purpose controlled human malaria infection.
15925584|NCT03454035|Drug|Ulixertinib|Ulixertinib 300mg, orally, twice a day concomitantly with palbociclib
15925554|NCT03454295|Behavioral|Enhanced Usual Care / EUC|"The enhancement to usual care in this study involves the inclusion of screening and targeted referral components as suggested by Reynolds et al. [79]. Research study assistants conducting the screening and providing feedback and referrals will be trained in the NCCN guidelines for distress management and will discuss the screening results and associated recommendations with the study PI (NCCN) [63]. As of November, 2017, ICs of patients seen in the Neurology Service at MSKCC are not consistently screened for distress and offered targeted referrals. Participants randomized to EUC will receive feedback about their level of distress (based on the Distress Thermometer administered at screening) after randomization. Within a week of randomization, and post-baseline, the study RSA will send EUC participants appropriate targeted referrals based on levels of distress and problem areas endorsed."
15925555|NCT03454282|Other|FMD|The Fasting Mimicking Diet (or FMD) consists in a 5-day plant-based, low-calorie (about 600 Kcal on day 1, followed by about 300 KCal/day on days 2 to 5), low-carbohydrate low-protein diet
15925556|NCT03454269|Diagnostic Test|Optical Coherence Tomography|The Optical Coherence Tomography is a painless analysis without contact with the eye. Patients are sitting in front of the machine. Each eye is analyzed. By a laser scanning system, longitudinal sections of the retina are made at the level of the macula and the optic nerve. The device automatically segments the different layers which are then measurable (in microns) by the ophthalmologist (duration of the analysis: 3 minutes).
15925557|NCT03454256|Device|Virtual Reality|Virtual Reality Rehabilitation System
15925558|NCT03454243|Drug|RXDX-106|Patients will receive continuous daily oral doses of RXDX-106 in 21 day cycles. To determine the maximum tolerated dose (MTD) and/or recommended phase 2 dose (RP2D), study drug will be administered in an escalated fashion starting at dose of 10 mg/day and will proceed at the dose levels prespecified by the dose escalation schema. Once daily dosing for RXDX-106 will initially be tested. However, other dosing schedules (eg, every other day, weight based, etc) may be tested based on safety and PK data to optimize drug exposure.
15925559|NCT03454230|Procedure|Positioning schedule|"Applying repositioning schedule daily adapted to pressure ulcer risk assessed with Braden scale. Then, the nurse will applied oil for PU prevention and repositioning which frequency will be defined by the Braden score. The positions will be the semi-fowler 30-30, the half-sitting position with a 45° angle position and patient lying on their back with the head up with a 30° angle for ventilator associated pneumonia prevention.
~Repositioning schedule will be applied according to the daily medical prescription. When physician allows to sit the patient on a chair, this have to be done by raising feet on a stool. Therefore, patients will stay in that chair as long as defined by positioning schedule. When patient is returned to bed, same positions as described above will be used alternately. In the time of positioning care, oil usually used for PU prevention will be applied on the skin of the areas of high risk of PU (heels, sacrum, elbows, trochanter, knees) and bone projections."
15925560|NCT03454217|Drug|Oxycodone|Postoperative pain treatment with oxycodone
15925561|NCT03454217|Drug|Tramadol|Postoperative pain treatment with tramadol
15925562|NCT03454204|Other|Pharmacokinetic|Analysis of blood samples
15925563|NCT03454191|Procedure|Erector spinae plane block|Injection of local anaesthetics below the erector spinae muscle after induction of anaesthesia
15925564|NCT03454191|Procedure|No injection|No injection
15925565|NCT03454178|Diagnostic Test|WatchBP Office (BP measurement machine)|BP measurement: The nurse or assistant will leave the room after confirmed validity and the WatchBP will automatically measure BP for the participant at 1-minute intervals for 3 more readings; previous research showed that accurate BP readings could be obtained using 1-minute intervals. This is also the measuring method suggested by the manufacturer. The machine will automatically calculate the mean BP using the 3 readings. The mean BP value will be used for analysis. The diagnostic cutoff for diagnosing HT will be ≥135/85 for AOBP
15925566|NCT03454165|Combination Product|BNC105P|BNC105P is the phosphate ester of BNC105, a small molecule tubulin polymerization inhibitor.
15925567|NCT03454165|Combination Product|Ibrutinib|A novel BTK inhibitor.
15925568|NCT03454139|Procedure|Subcostal transversus abdominis plane block|Ultrasound guided Subcostal transversus abdominis plane block is performed after anesthesia induction and endotracheal intubation , to the side where kidney stone is. A composition of 10 ml Lidocaine %1 plus 10 ml physiologic saline solution plus 10 ml Bupivacaine %0,5 , total of 30 ml of local anesthetic mixture is administered into the area between internal oblique muscle fascia and transversus abdominis muscle fascia.
15925569|NCT03454126|Drug|BIIB095|Administered as specified in the treatment arm.
15925570|NCT03454126|Drug|Placebo|Administered as specified in the treatment arm.
15925571|NCT03454113|Device|Ellipsys Vascular Access|The Ellipsys Vascular Access System comprises the Ellipsys Catheter, Ellipsys Crossing Needle and Ellipsys Power Controller. The Ellipsys Crossing Needle is used to facilitate access between the artery and the vein. The Ellipsys Catheter is placed percutaneously into the selected vein in close proximity to the selected artery. The Ellipsys Catheter is actuated at the selected anastomosis site, and the vein and artery are approximated. Once the vessels are in the appropriate relative positions the catheter is connected to the Ellipsys Power Controller to create the anastomosis after which the Ellipsys Catheter is removed, and the access site is closed using standard percutaneous closure techniques.
15925572|NCT03454100|Behavioral|multisectoral package of activities|A multi-sectoral package of village level activities, including having a well dug, a shared latrine installed, training on handwashing and hygiene across the water chain, training on conservation agriculture techniques, care groups for pregnant and breastfeeding mothers, and training on market gardens.
15925573|NCT03454087|Other|Enteral Dextrose Infusion|A standard solution of 50% Dextrose (0.85 kcal/mL) will be infused via enteral route at a rate of 10 mL per hour for a duration of 24 hours.
15925574|NCT03454087|Other|Free Water Infusion|An infusion of free water will be initiated via enteral route at a rate of 10 mL per hour for a duration of 24 hours.
15925575|NCT03454074|Behavioral|Problem-solving|Individualized goal-setting and group problem-solving to help older adults effectively integrate realistic, healthy behavioral changes into their everyday lives
15925576|NCT03454074|Behavioral|Education|Education about healthy brain aging behaviors provided.
15925577|NCT03454061|Other|physical activity|Physical education program (PEP) of 16-week length
15925578|NCT03454048|Drug|Piperaquine (low dose)|subcurative regimen (480 mg)
15925579|NCT03454048|Drug|Piperaquine (high dose)|Curative regimen (960mg)
15925585|NCT03454035|Drug|Palbociclib|Drug: Palbociclib 125mg, orally, once a day concomitantly with ulixertinib
15925586|NCT03454022|Behavioral|DART|A one-hour long web-based decision-aid program that explains treatment options for end-stage renal disease, including the benefits and risks of each treatment option.
15925587|NCT03454022|Behavioral|Choosing a Treatment for Kidney Failure|This is an educational pamphlet published by the National Kidney Foundation.
15925588|NCT03454009|Behavioral|Multimodal hygiene intervention|hygiene supplies including hand sanitizer, hand sanitizer surface disinfectant wipes and tissues, along with the following educational materials: a 2-minute electronic educational video; weekly 30-second electronic videos; and an educational flyer.
15925589|NCT03453996|Other|Intervention|"Computerized clinical decision support intervention. This intervention consists of 2 decision support components for CI-AKI prevention:
~Estimation of safe contrast limit to reduce the relative risk of CI-AKI by 20% (ePRISM Acute Kidney Injury Model with Contrast Sensitivities and Dialysis Risk software from Health Outcomes Sciences)
~Patient weight and left ventricular end diastolic pressure (LVEDP) based intravenous crystalloid fluid recommendation."
15925590|NCT03453996|Other|Control|Usual procedural care provided by cardiologist without introduction of the computerized clinical decision support information.
15925591|NCT03453983|Device|Transcrainial Direct Current Stimulation (tDCS)|Transcranial direct current stimulation (tDCS) is a safe non-invasive form of brain stimulation, which modulates, through the application of weak direct current, cortical excitability. The applied subthreshold current passes through two externally placed electrodes, an anode and cathode.
15925592|NCT03453970|Behavioral|Therapeutic Education Program|The total duration of the program will be 12 weeks with a maximum of 6 sessions of 30 minutes each. In the first session, through the EBADE questionnaire, the needs will be identified by grouping them by the 4 constructs of the theory of planned behavior (behavioral beliefs, subjective norm, behaviors of perceived control and behavioral intention). The interventions and the number of sessions will be adapted depending on the areas identified with barriers. These interventions will be applied in both face-to-face and telephone modalities, using the Nursing Intervention Classification and their respective activities. The interventions will be carried out by nurses who have previously received training on the proposed program. Follow-ups will be carried out every 15 days.
15925593|NCT03453957|Other|Professional development program|Professional development program consists of training including workshops and consultation sessions to enhance therapists ability to detect and repair alliance ruptures in active community based psychotherapy.
15925594|NCT03453944|Device|VentFree prototype (VF03-K) active stimulation|Abdominal wall muscle stimulation synchronised with mechanical ventilation. Stimulation frequency: 30 Hz, pulse width: 352us, max. intensity: 100mA (threshold intensity determined using ultrasound)
15925595|NCT03453944|Device|VentFree prototype (VF03-K) sham stimulation|Abdominal wall muscle sham-stimulation synchronised with mechanical ventilation. Stimulation frequency: 10 Hz, pulse width: 352us, intensity: 15 mA.
15925596|NCT03453931|Drug|Corticosteroid injection|Intravenous high dose corticosteroids
15925597|NCT03453918|Dietary Supplement|polyphenols|"After 6 hours of fasting, each patient will eat a complete meal course, containing 40 mg of iron, at two different days (wash-out period: 3 days between each meal).
~During each meal, each patient will receive, two capsules containing polyphenols or two placebo capsules (cross-over methodology). The meal in which each patient will receive either polyphenol or placebo will be randomized.
~The diet consists of :
~Starter: duck gizzard salad.
~Main course: black pudding and pasta.
~French cheese.
~Fruits: kiwi fruit.
~This diet contain approximately 40 mg of iron, with low polyphenol intake. Patients will be asked to eat the whole gizzard and black pudding to ensure the highest iron intake.
~At the end of the meal, blood samples will be collected at 0 minute, 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours, to assess serum iron level, in order to measure the area under the curve of iron kinetic."
15925598|NCT03453918|Other|Placebo|"After 6 hours of fasting, each patient will eat a complete meal course, containing 40 mg of iron, at two different days (wash-out period: 3 days between each meal).
~During each meal, each patient will receive, two capsules containing polyphenols or two placebo capsules (cross-over methodology). The meal in which each patient will receive either polyphenol or placebo will be randomized.
~The diet consists of :
~Starter: duck gizzard salad.
~Main course: black pudding and pasta.
~French cheese.
~Fruits: kiwi fruit.
~This diet contain approximately 40 mg of iron, with low polyphenol intake. Patients will be asked to eat the whole gizzard and black pudding to ensure the highest iron intake.
~At the end of the meal, blood samples will be collected at 0 minute, 30 minutes, 1 hour, 2 hours, 3 hours and 4 hours, to assess serum iron level, in order to measure the area under the curve of iron kinetic."
15925599|NCT03453905|Diagnostic Test|CTFEA|CT scans are used to generate a finite element model of patient-specific long bones. The bone model is loaded in stance position. Load based on patient's weight and the mechanical response, including the risk of fracture, is computed.
15925600|NCT03453905|Other|Conventional decision algorithm|Decision on surgery vs follow-up will be based on expert opinion and Mirels' score
15925601|NCT03453892|Drug|Nivolumab|The normal clinical treatment-plan of the underlying disease remains unchanged.
15925602|NCT03453892|Drug|Pembrolizumab|The normal clinical treatment-plan of the underlying disease remains unchanged.
15925603|NCT03453892|Radiation|Radiotherapy|The normal clinical treatment-plan of the underlying disease remains unchanged.
15925604|NCT03453892|Drug|Ipilimumab|The normal clinical treatment-plan of the underlying disease remains unchanged.
15925605|NCT03453879|Other|no intervention|No intervention - only observation of teams delivering acute obstetric care
15925606|NCT03453866|Procedure|Warmed Arthroscopic Fluids|Warmed Arthroscopic Fluids
15925607|NCT03453866|Procedure|Room Temperature Arthroscopic Fluids|Room Temperature Arthroscopic Fluids
15925608|NCT03453853|Device|Mitral Loop Cerclage Annuloplasty|Atrial Functional mitral regurgitation Response In mitral loop Cerclage Annuloplasty
15925609|NCT03453840|Drug|Artemether-lumefantrine|Children will receive the dispersible formulation of AL which contains 20 mg artemether, 120 mg of lumefantrine (Coartem® Dispersible). Weight-based dosing will be as below: <15kg, 1tablet; 15-25kg, 2 tablets; 25-35kg, 3 tablets; >=35kg, 4 tablets.
15925610|NCT03453827|Other|no intervention|no intervention
15925611|NCT03453814|Other|Music Therapy|Subjects will receive one hour of music twice a day for three days.
15925777|NCT03452306|Drug|Metformin|"Third Intervention Period:
~Single administered dose of Metformin (750 mg tablet extended-release) in a fed condition"
15925612|NCT03453801|Biological|Fluzone®|Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine): The pediatric dose (6-35 months) will be supplied in a prefilled, single dose syringe, 0.25 mL (no preservative). Each 0.5 mL dose of Fluzone® Quadrivalent (36 months-adult) will be supplied in a prefilled, single dose syringe, 0.5 mL (no preservative). Both formulations given IM.
15925613|NCT03453801|Biological|FluMist®|FluMist® Quadrivalent: live, attenuated influenza virus vaccine quadrivalent, given by intranasal spray
15925614|NCT03453788|Device|LETSGO app|LETSGO pilot test Group will test LETSGO app and partially nurseled follow-up
15925615|NCT03453775|Device|Ultrasound guided periradicular lumbar infiltration|Once position of the needle is confirmed, the mixture Depomedrol 40mg + Lidocaine 2% (1ml) is injected, under neurostimulation with an intensity of 0.2 milliampere (identifies a distance of 1mm from the nerve root allowing the protection of the root of a lesion by the needle).
15925616|NCT03453775|Device|Fluoroscopy guided periradicular lumbar infiltration|Once position of the needle is confirmed, the mixture Depomedrol 40mg + Lidocaine 2% (1ml) is injected, under neurostimulation with an intensity of 0.2 milliampere (identifies a distance of 1mm from the nerve root allowing the protection of the root of a lesion by the needle).
15925617|NCT03453762|Procedure|recruitment maneuver|Recruitment maneuver is provided with positive pressure of 30 cmH2O for 10 seconds.
15925618|NCT03453762|Procedure|ultrasonography-guided recruitment maneuver|Recruitment maneuver is guided by ultrasonography.
15925619|NCT03453749|Dietary Supplement|Salovum|Salovum is freeze dried egg yolk, highly enriched with anti-secretory factor. Salovum is registered as a medical food by the EU
15925620|NCT03453736|Other|No intervention|This is a qualitative study involving staff interviews and observations. No intervention is being applied.
15925621|NCT03453723|Procedure|Magic glove hypnosis technique|Realization of the magic glove hypnosis technique by an expert physician trained in hypnosis, according to a classic discourse before : intravenous infusion with 1% propofol (3 mg/kg with 600 ml / h electric syringe pump). Use and dose in accordance with the SPC.
15925622|NCT03453723|Drug|lidocaine|intravenous infusion with an extemporaneous mixture of 18 volumes 1% propofol (180mg) for 2 volumes of 1% lidocaine (2ml) with 600 ml / h electric syringe pump. Use and dose in accordance with the SPC.
15925623|NCT03453710|Procedure|Bankart Repair plus Remplissage|"Arthroscopic Bankart repair with a minimum of 3 anchors
~1 or 2 anchor Remplissage subsequently performed with percutaneous anchor insertion in the base of the Hill-Sachs defect, and sutures passed in a horizontal mattress configuration 1 cm apart, tied in the subacromial space."
15925624|NCT03453710|Procedure|Latarjet coracoid transfer|Coracoid transfer performed via deltopectoral approach with horizontal subscapularis split. Graft placed in the conventional orientation, secured with 2 screws, ensuring the graft is not lateral to the glenoid rim.
15925625|NCT03453697|Device|acute intermittent hypoxia|Adjust the proportion of nitrogen and oxygen, through increasing the suction nitrogen concentration, the subject's blood oxygen saturation could decrease to 80%~90% within 30 seconds and also lasts 30 seconds; then quickly reduce the concentration of nitrogen gas suction to make the subject's blood oxygen saturation gradually return to normal level (consistent with the air inhalation), and then continue breathing air about 60 seconds to enter the next round of hypoxic state.
15925626|NCT03453684|Drug|Administration of Vancomycin|Intravenous Vancomycin Administration
15925627|NCT03453671|Behavioral|Mindfulness|Participants will use mindfulness techniques while exercising
15925628|NCT03453671|Behavioral|Distraction|Participants will distract themselves while exercising
15925629|NCT03453671|Behavioral|Self-monitoring|Participants will use associative attentional focus while exercising
15925630|NCT03453658|Procedure|Manual instrumentation|Manual conventional files will be used in endodontic treatment of primary teeth
15925631|NCT03453658|Procedure|Reciprocating Instrumentation|Reciprocating files system will be used in endodontic treatment of primary teeth.
15925632|NCT03453645|Procedure|ventricular tachycardia ablation|The usual organization of hospitalization of the patients addressed for ventricular tachycardia ablation and his follow-up are not modified by the protocol. .
15925633|NCT03453632|Drug|Botulinic toxin|"Clinical photographs of the soles Standardized anesthesia protocol (lidocaine, prilocaine on soles, cryo-spray, oral administration of paracetamol and only if necessary oxycodone and hydroxyzine).
~Cleaning and antiseptic on the soles Injections of botulinic toxin (200 UI) on right or left foot"
15925634|NCT03453632|Drug|Placebo|"Clinical photographs of the soles Standardized anesthesia protocol (lidocaine, prilocaine on soles, cryo-spray, oral administration of paracetamol and only if necessary oxycodone and hydroxyzine).
~Cleaning and antiseptic on the soles Injections of physiological serum (200 UI) on right or left foot"
15925635|NCT03453619|Drug|APL-2|APL-2 administered as a daily subcutaneous infusion for 48 weeks
15925636|NCT03453606|Other|Home respiratory rehabilitation|Home care is individual (often with the spouse or the carer), during 1h30, one visit per week for 8 weeks, after completion of the educational diagnosis, under direct supervision of a member of the team, with continued physical activities in autonomy the others days of the week, according to a personalized action plan. No visit is scheduled in the pulmonologist, the general practitioner or in the rehabilitation center. The team includes pulmonologist, nurses, dietician, socio-medical beautician and a administrative assistant.
15925637|NCT03453606|Other|Center respiratory rehabilitation|"In an outpatient setting, the course is performed in groups of 6 to 8 patients, during sessions from 3 to 7 am, under the direction of health professionals, 3 to 5 times a week, for 4 to 6 weeks, for a total of 20 to 24 sessions. Internally, patients come to complete hospitalization for 4 weeks. This duration can be modulated according to the evolution of the patients.
~Supervision is carried out by the entire team including pulmonologists, nurses, physiotherapists, psychologists, activity professors adapted physicists, dietician"
15925638|NCT03453593|Other|No intervention|No intervention
15925639|NCT03453580|Radiation|multislice computed tomography portography|imaging modality
15925640|NCT03453567|Procedure|Valve Replacement|Aortic valve replacement
15925641|NCT03453554|Other|Digital Notebook app|Training in use of Digital Memory Notebook app
15925642|NCT03453554|Other|Smart Home Prompting|Smart-home sensor based activity-aware prompting to support digital memory notebook app use
15925778|NCT03452306|Drug|Glucophage® Long|"Fourth Intervention Period:
~Single administered dose of Metformin (750 mg tablet extended-release) in a fed condition"
15925643|NCT03453541|Drug|Ketorolac Tromethamine|Ketorolac Tromethamine 0.5 mg/kg IV up to a maximum dose of 30mg, in the form of Ketorolac Tromethamine solution for IV/IM use 30mg/ml single dose vial at the completion of the tonsillectomy in the operating room.
15925644|NCT03453541|Drug|0.9% Normal Saline|0.9 % Normal saline 1ml/60kg up to a maximum dose of 1ml IV bolus (an equivalent volume as per kg Ketorolac Trimethamine dose) at the completion of the tonsillectomy in the operating room.
15925645|NCT03453528|Drug|68Ga-PSMA|68Ga-PSMA will be injected intravenously via an indwelling catheter in an antecubital vein; (68Ga-PSMA activity: min 100 MBq - max 200 MBq, weighted activity: 2.0 MBq/Kg).
15925646|NCT03453515|Behavioral|HEART|Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.
15925647|NCT03453515|Behavioral|Growing Minds|Interactive web-based intervention with five modules: mindsets introduction, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and integrative summary.
15925648|NCT03453502|Behavioral|Quality improvement of breast milk feeding|During the Intervention phase and Sustainability phase ,The NICUs will receive training of multiple evidence based quality improvement methods.
15925649|NCT03453489|Other|Carbon C 11 Alpha-methyltryptophan|Undergo AMT-PET
15925650|NCT03453489|Other|Laboratory Biomarker Analysis|Correlative studies
15925651|NCT03453489|Procedure|Positron Emission Tomography|Undergo AMT-PET
15925652|NCT03453489|Drug|Telotristat Etiprate|Given PO
15925653|NCT03453476|Device|SRP and Fotosan 630|After isolating the test quadrants with cotton roll, toluidine blue was applied into the deep pockets (PD ≥ 4mm) at the test quadrants for 10 seconds, followed by inserting a perio tip (15 or 21 mm depending on the depth of the pocket) that connected to a LED emitting device, and light was emitted for 20 seconds. Toluidine blue in the deep pocket was removed by injecting normal saline into the pocket.
15925654|NCT03453463|Other|exercise|3x week predominately resistance exercise for 18 months
15925655|NCT03453437|Behavioral|Mindful Self-Compassion|Mindful self-compassion is a course developed by Kristin Neff and Christopher Germer designed to cultivate self-compassion as measured by three subcategories: self-kindness, mindfulness, and a sense of common humanity. This study will shorten the original 8-week course to 5 sessions, and will include interventions and lectures aimed directly toward addressing evaluative concerns perfectionism.
15925656|NCT03453424|Procedure|TEA+DEX|intra and post operative TEA infusion of (bupivacaine +fentanyl 2 mic/ ml+ dexmedetomidine 0.5 mic/ ml) Under strict aseptic precautions thoracic epidural was performed using a 16 gauge,Tuhy epidural needle by a paramedian approach. T8-T9 inter space was chosen for the injection. Skin at insertion site was anesthetized by 3 ml of lidocaine 1%, the epidural space was identified by the loss of resistance technique, the catheter was introduced approximately 2-4 cm into the epidural space, epidural test dose consisted of 3 ml of lidocaine 2 % with 1: 200,000 adrenaline.
15925657|NCT03453424|Procedure|TEA|"Under strict aseptic precautions thoracic epidural was performed using a 16 gauge,Tuhy epidural needle by a paramedian approach. T8-T9 interspace was chosen for the injection. Skin at insertion site was anesthetized by 3 ml of lidocaine 1%, the epidural space was identified by the loss of resistance technique, the catheter was introduced approximately 2-4 cm into the epidural space, epidural test dose consisted of 3 ml of lidocaine 2 % with 1: 200,000 adrenaline.
~then, intra and post operative TEA infusion of bupivacaine 0.125%+fentanyl 2 mic/ ml."
15925658|NCT03453411|Other|Non interventional study|Non interventional study
15925659|NCT03453398|Other|Shifts working hours with different schedules|"Workers in Group 1, 2, and 3 will undergo three different shift work modalities presenting different schedules.
~Importantly, as an inclusion criteria, workers have to be involved in the same shift modality for at least one year at the time at the beginning of the study."
15925660|NCT03453385|Behavioral|Electronic Cigarette|An e-cigarette and four weeks of e-liquid provided to participants.
15925661|NCT03453372|Device|MRgFUS Treatment|Treatment of pain caused by knee osteoarthritis with high-intensity focused ultrasound
15925662|NCT03453372|Other|Placebo|Procedures in the placebo group will be identical to procedures in the active group, except no sonications (ultrasound emission) will be used.
15925663|NCT03453359|Device|BIS monitor|The investigators will place on the forehead of all patients the sensor BIS quatroTM, that connects with this monitor, and they will guide sedation and will record the values obtained.
15925664|NCT03453359|Device|Ramsay scale|In this group, sedation is guided by the Ramsay monitoring scale. The investigators will talk with the patients and will determine the corresponding level of sedation.
15925665|NCT03453346|Drug|Sofosbuvir|Generic sofosbuvir tablet 400 mg
15925666|NCT03453346|Drug|Ribavirin|Ribavirin was provided in 100-mg tablets.
15925667|NCT03453333|Procedure|3D laparoscope|For laparoscopic camera system, a 10-mm ENDOEYE FLEX 3D Deflectable Videoscope (Olympus Corp., Germany) was used in the 3D group.
15925668|NCT03453333|Procedure|2D laparoscope|For laparoscopic camera system, a 10-mm 30º IDEAL EYES Laparoscope (Stryker, Kalamazoo, MI, USA) camera was used in the 2D group.
15925669|NCT03453320|Drug|Albumin solution|Infusion rate and effects
15925670|NCT03453294|Device|Apnoeic oxygenation using THRIVE|Apnoeic oxygenation using THRIVE
15925671|NCT03453294|Device|Endotracheal intubation and mechanical ventilation|Endotracheal intubation and mechanical ventilation
15925672|NCT03453281|Drug|Aflibercept Injection [Eylea]|Intravitreal Aflibercept injections were performed by vitreoretinal consultant at the place of study.
15925673|NCT03453268|Other|STEP DOWN strategy|"reduction of the number of antihypertensive medication according to:
~the systolic blood pressure levels,
~co-morbidities"
15925674|NCT03453268|Other|Control|usual treatment
15925675|NCT03453255|Drug|Chemotherapy|chidamide, decitabine, homoharringtonine, cytarabine
15925676|NCT03453242|Other|Bone measurement by HR-pQCT and ultrasound|Measurement will be performed at radius and at tibia (ultra-distal and distal). For all the sites one measurement will be performed by HR-pQCT to get reference values of thickness and BMDs. For the distal positions and additional measurement will be performed by an innovative ultrasound device that estimates cortical thickness and porosity.
15925779|NCT03452293|Device|Stent Peripheral System|Peripheral PTA with Supera Stent implantation
15925780|NCT03452267|Drug|Metformin|oral, 850 mg twice daily
15925781|NCT03452267|Drug|Pioglitazone|oral, 45 mg daily
15925782|NCT03452267|Drug|Placebo|oral, once daily
15925677|NCT03453216|Behavioral|neuropsychological tests|"Part 1: to determine the cognitive capacity, the subjects undergo different neuropsychological tests To determine individual characteristics children, adolescents and adults complete self-assessment questionnaires .
~Adults spend a semi-directive interview. Part 2: while the subject 1 (S1) is installed in the MRI, he perform behavioral tasks with the subject 2 (S2) (familiar peer of the same age ± 2 years) installed in an adjacent room, alternating periods when S1 is observed by S2 (condition Social) and periods when S1 is not observed by S2 (condition Alone)."
15925678|NCT03453203|Other|Osteopathic Manipulative Treatment Using Counterstrain|Described in arm/group descriptions
15925679|NCT03453190|Combination Product|Apremilast and Clobetasol|Patients will receive apremilast and clobetasol with tapering dosages over 16 weeks.
15925680|NCT03453177|Drug|Standard of Care + Fosfomycin|Fosfomycin will initially be administered IV for at least 48 hours together with standard care (ampicillin + gentamicin). Then, once babies are tolerating oral feeds and clinically improved, fosfomycin will be changed to oral administration to complete a total of 7 days of fosfomycin (or until the baby is discharged).
15925681|NCT03453177|Procedure|PK|Two PK samples will be taken after each of the first IV and oral doses, with sampling times allocated within possible early (5, 10 or 60 minutes) and late (2, 4 or 8 hours) time-points after starting the IV and PO formulations; then again together with biochemistry after 7 days for those babies whom remain as inpatients.
15925682|NCT03453177|Procedure|Analysis of Bacterial Isolates|For assessment of susceptibility patterns in bowel flora, we will systematically assess all admission and discharge nappy swabs.
15925683|NCT03453164|Radiation|Radiotherapy + Nivolumab|Radiotherapy of 22.5 Gy/5 fractions/5 days will be given to a symptomatic lesion or the largest asymptomatic lesion suitable for irradiation from Day 1. Nivolumab will be administered intravenously starting on Day 15-22 at a dose of 3 mg/kg (body weight) every 2 weeks to a total of 6 courses of administration.
15925684|NCT03453151|Drug|splanchnic nerve anesthesia with a local anesthetic|regional nerve block with a local anesthetic (Lidocaine/Bupivacaine)
15925685|NCT03453138|Device|LMA Protector|LMA Protector will be inserted by a blind researcher after standart anesthesia induction. The view of the larynx will be assessed using fiberoptic grading scale
15925686|NCT03453138|Device|Tracheal Intubation|tracheal intubation will be perform after standart anaesthetic induction and heamodynamic variables including blood pressure heart rate and possible complications will be observed
15925687|NCT03453125|Behavioral|Spanish modified Story Memory Technique (mSMT)|
15925688|NCT03453112|Drug|Foster 100/6mg NEXThaler|Fixed combination of beclomethasone dipropionate 100mg plus formoterol fumarate 6mg per actuation as inhalation powder with a new dry powder inhaler
15925689|NCT03453112|Drug|Foster 100/6mg pMDI|Fixed combination of beclomethasone dipropionate 100mg plus formoterol fumarate 6mg per actuation as pMDI with HFA_134a propellant
15925690|NCT03453099|Other|Preoperative Questionnaires|"The participants will be asked to complete 5 questionnaires:
~An abbreviated version of the Caffeine Assessment Tool (CAT)
~Sleep Questionnaire (SQ)
~Surgical Fear Questionnaire (SFQ)
~WHO Alcohol AUDIT Tool
~WHO Smoking Questionnaire
~They will also be asked to complete a demographics sheet
~All participants will undergo standard anaesthetic induction, a research participant will observe the dose of propofol and time taken for loss of consciousness"
15925691|NCT03453099|Other|Postoperative Subjective Pain Scores|After the operation, participants will be provide with a scale from 1-10 in which to rate their pain at rest and whilst coughing. This will be undertaken at 1hr postoperatively.
15925692|NCT03453086|Procedure|Thoracic paravertebral block(TPVB) group|"Thoracic paravertebral block group (TPVB) group: The midpoint of the transducer is to be placed in a longitudinal paramedian plane between two transverse processes.Tuohy needle will be introduced in a cephalad direction. The tip of the needle will be advanced under direct visualization until it pierces the superior costo-transverse ligament. When the needle tip is located immediately above the pleura, the needle is aspirated to confirm the absence of blood or air.
~Serratus anterior plane block group (SAP) group: The US probe will be placed over the mid-clavicular region of the thoracic cage in a sagittal plane. The ribs will be counted until the 5th rib is identified in the midaxillary line. The latissimus dorsi, teres major and serratus muscles will be then easily identifiable by US overlying the fifth rib. The needle will be introduced in-plane with respect to the US probe from supero-anterior to postero-inferior"
15925693|NCT03453073|Behavioral|chocolate consumption level|level of consumption of 1 oz. of chocolate, as assessed at baseline
15925694|NCT03453073|Other|physician diagnosis of first occurrence of serious chronic disease|
15925695|NCT03453060|Drug|E-WE Thrombin- Dose 1|Participants received a single intravenous dose of 0.5 mcg/kg E-WE Thrombin.
15925696|NCT03453060|Drug|E-WE Thrombin- Dose 2|Participants received a single intravenous dose of 1.0 mcg/kg E-WE Thrombin.
15925697|NCT03453060|Drug|E-WE Thrombin- Dose 3|Participants received a single intravenous dose of 2.0 mcg/kg E-WE Thrombin.
15925698|NCT03453060|Drug|E-WE Thrombin- Dose 4|Participants received a single intravenous dose of 4.0 mcg/kg E-WE Thrombin.
15925699|NCT03453060|Other|Placebo|Participants received a single intravenous dose of placebo.
15925700|NCT03453047|Diagnostic Test|S100β and Neuron specific enolase (NSE)|S100β is 10.4 kDa protein. Synthesized with end feet processes of astrocytes in the brain S100β belongs to low molecular weight EF-hand type acidic calcium binding protein superfamily. This protein is metabolized in the kidneys and removed with urine. It is shown that S100β does not show differences due to ethnical groups or genders and is not affected by circadian rhythm. Although S100β is also found in other tissues, it is in higher concentrations in the brain so it can be used as an early indicator for brain damage.NSE is an SSS protein which exists in neurons and neuroendocrine tissues. NSE plays a role in glycolytic route in neurons as intracytoplasmic enzyme increasing serum level in case of neuron damage. Whilst S100β is the marker of astroglia dysfunction, NSE is the marker of neuronal dysfunction.
15925701|NCT03453034|Drug|TQ-B3233|QD or BID in different stage of this research
15925702|NCT03453021|Drug|Mepolizumab|
15925783|NCT03452254|Device|Active Bihemispheric Transcranial direct current Stimulation|"The session will start with the application of the with a couple of surface sponge electrodes (25-35 cm2) on the scalp. The treatment modality will be as follows:
~Active tDCS: The anodic electrode will be put on affected M1. The cathodic electrode will be put on contralateral M1. We will apply a constant current of 2mA of intensity during 20 minutes while the patient performs the occupational therapy session."
15925703|NCT03453008|Other|elbow extension, electromyography|"Two evaluations before the toxin injection (T0 and T1), to quantify cocontractions and to determine the toxin injection pattern.
~The first evaluation (T0) will be carried out within a period of between 1 month and 15 days before the injection. This evaluation makes it possible to pose the indication for the realization of injection of Botulinum Toxin A (TBA).
~The second evaluation (T1) will be performed on the day of the injection to specify the muscle targets to be injected.
~The first evaluation is a Clinical evaluation and second is Instrumental evaluation"
15925704|NCT03452995|Procedure|PHYSIOTHERAPY|Lymphodreinage and kinesiotaping are current methods of treatment of edema, pain and indirectly recovery of the knee ROM in TKA. Edema, pain and knee ROM are strictly corelated and, by reducing edema, we reduce the pressure by relieving pain, and allowing an improvement in movement.
15925705|NCT03452982|Other|sentinel node technique|Injection of a tracer in the stump of the infundibulo-pelvic ligament and uterus-ovary for sentinel node detection.
15925706|NCT03452969|Other|Implantation of multifocal intraocular lens|"Procedure/Surgery:
~Bilateral implantation of a segmental refractive multifocal intraocular lens (MIOL) following cataract surgery."
15925707|NCT03452956|Other|None-Observation Only|No intervention-this is an observational study
15925708|NCT03452943|Drug|TEV-50717|6, 9, 12, 15, and 18 mg oral tablets
15925709|NCT03452943|Drug|Placebo|Placebo matched to TEV-50717 tablets will be taken BID for 12 weeks.
15925710|NCT03452930|Radiation|Radiation Therapy|Undergo RT
15925711|NCT03452930|Drug|Tinostamustine|Given IV
15925712|NCT03452917|Drug|Placebo|500 patients will 2 ml of normal saline
15925713|NCT03452917|Drug|sodium nitrite 45 mg|500 patients will receive 45 mg IV sodium nitrite
15925714|NCT03452917|Drug|sodium nitrite 60 mg|500 patients will receive a dose of 60 mg IV sodium nitrite
15925715|NCT03452904|Device|Drug-coated balloon|Treatment of in suit coronary lesions with drug-coated balloon
15925716|NCT03452904|Device|Drug-eluting stent|Treatment of in suit coronary lesions with drug-eluting balloon
15925717|NCT03452891|Other|Methylcellulose|Methylcellulose gel will be placed in a deep (6-9 mm) periodontal pocket.
15925718|NCT03452891|Drug|Simvastatin-Methylcellulose|Simvastatin-Methylcellulose gel will be placed in a deep (6-9 mm) periodontal pocket.
15925719|NCT03452878|Behavioral|Aggressive behavior|Aggressive Behavior Scale, Quality of Life (SF-36) and Agitated Behavior Scale, measurement of thyroid-stimulating hormone (TSH), T4, T3, Cortisol, Luteinizing Hormone (LH), Estradiol, Prolactin, Progesterone, testosterone, and sex hormone-binding globulin (SHBG) and Resonance Magnetic Imaging.
15925720|NCT03452865|Drug|Esomeprazole|"160 mg of esomeprazole will be diluted in 100 ml of 0.9% sodium chloride for intravenous use for bolus.
~For continuous intravenous infusion, 40 mg of esomeprazole will be reconstituted by adding 5 ml of 0.9% sodium chloride for intravenous use at a concentration of 8 mg/ml."
15925721|NCT03452865|Drug|Placebo|0.9% sodium chloride (same ml of the study drug)
15925722|NCT03452852|Device|PICO|NPWT with PICO (Smith and Nephew)
15925723|NCT03452852|Other|Coban 2 lite|Compression bandaging with Coban 2 lite
15925724|NCT03452839|Drug|Meropenem|Meropenem or injection vials to be re-constituted in a solution of NaCl 0.9%.
15925725|NCT03452826|Device|Antibiotic therapy according to the result of mPCR (device)|"Phone call at D28 and D90, unless the patient is still hospitalized;
~Collection of a respiratory tract sample (either distal, i.e. tracheal aspirate or bronchoalveolar lavage, or proximal, i.e. sputum) for broad panel respiratory mPCR in the intervention arm.
~Collection of an additional respiratory tract sample for biological banking in both arms."
15925726|NCT03452787|Other|None, cohort studies|this is a metanalysis of previously obtained observational data. there is not intervention on any of the cohorts.
15925727|NCT03452774|Other|Clinical Trial Matching|Using a proprietary application programming interface (API) linked to existing electronic health records (EHR) platforms, individual clinical data is extracted, analyzed and matched to a parametric database of existing institutional and non-institutional CT. Machine learning algorithms allow for dynamic matching based on CT allocation and availability for optimized matching.
15925728|NCT03452761|Dietary Supplement|Ketone Salts|Subjects will take 2 servings of ketone salts daily for 6 weeks
15925729|NCT03452748|Device|FTIR spectroscopy|FTIR spectroscopy examines collagen fibers in the excised membranes
15925730|NCT03452735|Other|Questionnaire about fertility|Sending a questionnaire about fertility that will have to be returned to us in order to be included in the study. The questionnaires, anonymous, will be numbered according to their order of return.
15925731|NCT03452722|Drug|intraventricual recombinant tissue plasminogen activator application|
15925732|NCT03452709|Behavioral|therapeutic exercise|The duration of the groups is planned to be from 12 weeks with 3 programmed sessions per week. physical activity programmed by an instructor in patient with high risk of cardiovascular.
15925733|NCT03452709|Device|ABPM ambulatory blood pressure monitoring|Arterial pressure is a biological variable which fluctuates over a 24 hour period depending on the period of activity/rest, which is known as circadian the BP rhythm. Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) vary, on average, more than 50 mm Hg throughout the day in a normotensive adult.
15925734|NCT03452696|Dietary Supplement|Calcium supplement|Calcium supplement for low contribution of elemental calcium in the daily diet
15925735|NCT03452683|Behavioral|Movn Mobile App|Movn is a mobile application that is downloaded to a cell phone where participants can enter their weight and symptoms every day.
15925736|NCT03452670|Behavioral|Active Group|Participants will be provided with a contemplative well-being application (CWA) which will facilitate meditation for 10 minutes daily during the 8 week study period.
15925737|NCT03452670|Other|Waitlist Group|The waitlist group will be maintained as a control group throughout all assessments and will be provided enrollment in CWA at the end of the 8 week study period.
15925738|NCT03452657|Drug|Ranibizumab|Participants in arm Ranibizumab will receive ranibizumab injection every 4 weeks for the first 3 months, followed by re-injections every 3 months until 1year
15925739|NCT03452657|Procedure|No drug|Participants in arm Sham-injection will receive sham injection every 4 weeks for the first 3 months, followed by re-injections every 3 months until 1year.
15925813|NCT03452033|Drug|H-1337 [1]|H-1337 Ophthalmic Solution Concentration 1
15925814|NCT03452033|Drug|H-1337 [2]|H-1337 Ophthalmic Solution Concentration 2
15925740|NCT03452618|Diagnostic Test|diagnosis variables|"The study compare the diagnostic variables in patients who received Non invasive ventilation equipment one year after diagnosis with the patient who don't need it. For the independent variables, the present study determine a threshold at the diagnosis for which an early fitting risk appears
~The diagnostic variable are :
~Age of the patient
~Sex
~Presence of bulbar involvement or not
~Time from onset of first symptoms to diagnosis of ALS
~Score ALSFRS-R
~Presence of another underlying respiratory pathology (COPD, asthma ...)
~FVC measurement (Forced vital capacity)
~PaCO2 measurement
~Measure SNIP (Sniff nasal inspiratory pressure)
~Measure of Pimax (Pressure inspiratory maximal)
~Measurement of the nocturnal desaturation index (number of desaturation less than 90% per hour of sleep)"
15925741|NCT03452605|Dietary Supplement|cocoa flavanol supplementation|cocoa flavanols (containing 196 mg epicatechin)
15925742|NCT03452592|Drug|Alflutinib|Patients take Alflutinib orally once per day at dose of 80 mg or 160 mg
15925743|NCT03452579|Drug|Nivolumab|240mg
15925744|NCT03452579|Drug|Standard Dose Bevacizumab|10mg/kg
15925745|NCT03452579|Drug|Low Dose Bevacizumab|3mg/kg
15925746|NCT03452566|Drug|Ingenol mebutate gel|3+3 phase 1 design as described above. After the maximum tolerated dose is defined, the phase 2 segment of the study will take place. Simon's Phase 2 study design tool was used, reinforced by Jung's admissible study designs for phase 2 clinical trials. Considering the margin of error of 0.05 and study power of 80%, and estimating the probability of placebo partial response of 15% and partial response to ingenol mebutate in 45%, the optimized number of patients to be recruited is 19. Six patients will be seen in the first stage of this segment of the study, and if only one patient or none has a partial response, the study will be promptly discontinued. Otherwise, the second and final stage of segment of the study will include an additional thirteen patients who will be treated.
15925747|NCT03452553|Device|LC Bead LUMI™ (Radiopaque (RO) Bead) loaded with doxorubicin|Drug Eluting Beads loaded with chemotherapy
15925748|NCT03452540|Drug|DS102|Participants will receive 1000mg DS102 capsules twice per day.
15925749|NCT03452540|Other|Placebo|Participants will receive placebo capsules twice per day.
15925750|NCT03452527|Biological|ICON-1|ICON-1 0.6 mg by intravitreal injection
15925751|NCT03452527|Biological|aflibercept|aflibercept 2 mg by intravitreal injection
15925752|NCT03452501|Drug|Infliximab|A vial containing powder for concentrate for solution for infusion. Each vial contains: Infliximab 100 mg
15925753|NCT03452488|Drug|BIO101|"Oral capsules containing the BIO101 active principle is 20-hydroxyecdysone (20E) at 97%.
~Component : 251 mg per capsule including 175 mg of active principle 20E containing also the following compendial excipients: colloidal silica, microcrystalline cellulose and magnesium stearate."
15925754|NCT03452488|Drug|Placebo oral capsule|Oral capsules containing Microcrystalline cellulose, Colloidal anhydrous silica
15925755|NCT03452475|Drug|Arterolane-piperaquine|Arterolane maleate-piperaquine phosphate tablets (37.5 mg/187.5 mg)
15925756|NCT03452475|Drug|Arterolane-piperaquine+mefloquine|Arterolane maleate-piperaquine phosphate tablets (37.5 mg/187.5 mg) Mefloquine tablets (250 mg)
15925757|NCT03452475|Drug|Artemether-lumefantrine|Artemether-lumefantrine tablets (20 mg/120 mg)
15925758|NCT03452462|Device|Pacing|Programming of either Direct His Bundle pacing or biventricular pacing
15925759|NCT03452449|Procedure|planned lumbar spine surgery|planned lumbar spine surgery including decompression, discectomy, foraminotomy, laminectomy
15925760|NCT03452423|Procedure|ACRFP|Arthroscopic cartilage regeneration facilitating procedure (ACRFP) is a set of surgical procedures that combines resection of medial plica, medial and lateral capsular release, synovectomy of focal synovitis, and chondroplasty of loosened cartilage flaps as a rationale for the deliberate arthroscopic management of osteoarthritic knee.
15925761|NCT03452397|Drug|OC-02|OC-02
15925762|NCT03452397|Drug|Placebos|Placebo
15925763|NCT03452384|Other|Acupuncture|For real acupuncture, disposable acupuncture needles (0.22 x 30-mm sterile stainless needles) were inserted into acupoints for a depth of 10-30 mm in a direction oblique or parallel to the surface. To ensure allocation concealment, the inserted needles were affixed with adhesive tapes so that real acupuncture procedure will be identical to control acupuncture procedure. For sham acupuncture procedure, Streitberger's noninvasive placebo acupuncture needles will be used. Its validity and credibility have been well demonstrated (Streitberger and Kleinhenz, 1998).
15925764|NCT03452371|Behavioral|Patient Navigation|Navigators will also screen participants for barriers to smoking cessation. Patient navigation intervention calls will use motivational interviewing (MI) strategies to: (1) Assess stage of change; (2) Assess and reinforce any prior abstinence from smoking and/or any efforts made to reduce/quit smoking; (3) Explore motivation to quit smoking, drawing on recent illness, financial/family situations as appropriate; advise about the risks of smoking and benefits of quitting (4) Discuss past experience with utilizing cessation support; (5) Explore potential barriers to using smoking cessation medications; (6) Brainstorm strategies to address identified barriers; (7) Elicit commitment to accept another patient navigation counseling call, discuss timing.
15925765|NCT03452371|Behavioral|Enhanced Traditional Care|Enhanced traditional care will include a resource card with information on quitlines, Boston Medical Center's (BMC's) Tobacco Treatment Center Program number, and websites for smoking cessation.
15925766|NCT03452358|Procedure|Partial Ceramic Indirect restoration|Placement of an partial ceramic indirect restoration with the use of immediate dentin sealing as an adjunct to adhesive cementation.
15925767|NCT03452345|Drug|Meditoxin|Meditoxin (Botulinum toxin type A)
15925768|NCT03452345|Drug|Placebo|Placebo (Normal saline)
15925769|NCT03452332|Biological|Durvalumab|Given IV
15925770|NCT03452332|Other|Laboratory Biomarker Analysis|Correlative studies
15925771|NCT03452332|Radiation|Stereotactic Radiosurgery|Undergo SABR
15925772|NCT03452332|Biological|Tremelimumab|Given IV
15925773|NCT03452319|Other|Pretraining|Increased physical activity, and daily strength training and breathing exercises.
15925774|NCT03452319|Other|Usual care|Preoperative information
15925775|NCT03452306|Drug|Metformine|"First aIntervention Period:
~Single administered dose of Metformin (750 mg tablet extended-release) in a fasting condition"
15925776|NCT03452306|Drug|Glucophage® Long|"Second Intervention Period:
~Single administered dose of Glucophage® (750 mg tablet extended-release) in a fasting condition"
15925815|NCT03452033|Drug|H-1337 [3]|H-1337 Ophthalmic Solution Concentration 3
15925784|NCT03452254|Device|Sham Bihemispheric Transcranial direct current Stimulation|"The session will start with the application of the with a couple of surface sponge electrodes (25-35 cm2) on the scalp. The treatment modality will be as follows:
~Sham tDCS: We will use the same place and parameters of stimulation applied for the active group, but the stimulator will deactivate after 30 seconds of stimulation. This will ensure that the patient will feel the initial tingling sensation at the beginning of the tDCS which is a requisite for blinding. The occupational therapy session will last one hour."
15925785|NCT03452254|Other|Modified Constraint Induced Movement Therapy|"Both groups will perform the mCIMT during a period of seven consecutive days. This protocol consists of two elements:
~Restriction of the movements of the non-affected hand by wearing a mitt during six hours a day: we will use a mitt that limits the movement of the fingers but allows the free movements of the wrist, elbow, and shoulder.
~Intensive and individualized training of the affected arm during 2 hours a day guided by an occupational therapist: the two hours training will be divided into two sessions of one hour each. Sessions will be organized in three blocks: preparation, activation, and function. In the third block, devoted to function, the patient has to choose one activity of daily living that he wants to improve."
15925786|NCT03452241|Other|Intervention Group|The medical staffs who received the training will use the manual of brief intervention to deliver BI and other materials about the harm of substance use.BI refers to a standard 15-30 minute intervention that includes a series of standard models that stimulate knowledge, motivation and behavior that reduce substance abuse.the harm of substance use is a dedicated paper publicity handbook, written by the SHMC, detailing the hazards of substance abuse.
15925787|NCT03452241|Other|Control Group|The participants only receive the materials about the harm of substance use.the harm of substance use is a dedicated paper publicity handbook, written by the SHMC, detailing the hazards of substance abuse.
15925788|NCT03452228|Drug|evinacumab|Administered by Intravenous (IV)
15925789|NCT03452228|Drug|Placebo|Administered by Intravenous (IV)
15925790|NCT03452215|Behavioral|Mobile Phone Application Educational Resources|Mobile Phone Application Educational Resources
15925791|NCT03452215|Behavioral|Mobile Phone Application GWG Tracker|Mobile Phone Application GWG Tracker
15925792|NCT03452202|Device|Soterix 1x1 line tDCS low-intensity stimulator|Introduction of the independent variable (treatment) across three different points in time. Participants will be randomly assigned to have each treatment phase begin after 3, 4, or 6 baseline sessions. This current stimulates the cortex, with anodal stimulation leading to a depolarized state in which neurons are more likely to fire.
15925793|NCT03452202|Device|Sham|Patients will have two electrodes applied (one anode, one cathode) administering no stimulation
15925794|NCT03452189|Drug|Vancomycin|Oral vancomycin 250mg capsules
15925795|NCT03452189|Other|Placebo|"Placebo Pills distributed by Research Pharmacy labeled placebo."
15925796|NCT03452176|Device|Scrambler|Scrambler is a non-invasive pain modifying technique that utilizes transcutaneous electrical stimulation of nociceptive fibers with the intent of re-organizing maladaptive signaling pathways which has been investigated for treatment of peripheral neuropathy.
15925797|NCT03452176|Device|Scrambler Sham Control|Sham control should be indistinguishable to the participants from experimental Scrambler therapy.
15925798|NCT03452163|Device|PMD-200|"the patients will be monitored by PMD-200. The technology consists of measurements of a number of nociception-related physiological parameters that corresponds with the autonomic nervous system's response to noxious stimuli, and using the company's proprietary algorithms, 'translating' these measurements into an index that represents the nociceptive response, the NoL™ (Nociception Level) Index. The NoL index is a relative index from 0 to 100, while 0 is no pain/nociception and 100 is extreme pain/nociception."
15925799|NCT03452163|Device|EEG monitor|An EEG device will be connected to the patient and display the Spectral Edge Frequency (SEF) signals and values on the subject monitor.
15925800|NCT03452150|Drug|D-0316|If initial dosing of D-0316 is tolerated then subsequent cohorts will test increasing doses until a maximum tolerated dose or maximum feasible dose is defined
15925803|NCT03452124|Device|I quit ordinary smoking (IQOS)|I quit ordinary smoking (IQOS) assisted cessation program
15925804|NCT03452124|Other|Conventional cigarette|Conventional cigarette smoking continuation
15925805|NCT03452111|Drug|Nestorone + Testosterone Combination Gel|The combined gel is a transdermal treatment that will be applied daily for 52 weeks to a male subject's arms and shoulders. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62 mg of T that will deliver approximately 6 mg T to the body per day. This gel volume will also contain 8 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 62 mg/d (NES8/T62) gel).
15925806|NCT03452085|Device|artificial saliva spray (AS)|cross over design
15925807|NCT03452085|Other|maritime throat spray (TT)|cross over design
15925808|NCT03452072|Drug|0.25% Timolol gel with paraffin gauze dressings|Timolol 0.25% gel will be applied to wound bed immediately after surgery before dressing is applied. Starting the day after surgery: each day, the patient will cleanse the surgical site, apply 0.25% topical timolol gel (1 drop = 0.1ml for each cm2 of wound area), and re-cover wound with clean dressing
15925809|NCT03452072|Other|Vaseline dressing|Vaseline will be applied to wound bed immediately after surgery before dressing is applied. Starting the day after surgery: each day, the patient will cleanse the surgical site, apply Vaseline, and re-cover wound with clean dressing
15925810|NCT03452059|Device|AiLegs, AiWalker and HKAFO|5 days. Using their own control method, each morning using AiLegs, AiWalker AiWalker and HKAFO for 6 minutes walk test, three kinds of appliance between at least 30 minutes to determine heart rate, blood pressure and breathing back to quiet level. Repeat the same procedure in the afternoon ，the order is also random. Each participant will complete 10 groups of lower limb exoskeleton rehabilitation Training robot (including AiLegs, AiWalker two models) and HKAFO 6 minutes walking test
15925811|NCT03452046|Other|IVC diametres|
15925812|NCT03452033|Drug|H-1337 Placebo|H-1337 Placebo Vehicle
15925816|NCT03452020|Device|Temperature measurementsusing the Tyto thermometer, the standard of care thermometer and the predicate thermometer|Temperature measurements using the Tyto thermometer, the standard of care thermometer and the predicate thermometer
15925817|NCT03452007|Device|Epidural Stimulation|Spinal cord epidural stimulation will be administered through a multi-electrode array implanted in the epidural space over the dorsum of the spinal cord. An implanted package containing stimulating circuits, rechargeable battery, and wireless communication activates the electrodes (16 platinum electrodes arranged in three columns of [5-6-5]). The pattern of electrically active electrodes, as well as electrode voltage, stimulating frequency, and stimulating pulse width will be varied to facilitate effects toward bladder function.
15925818|NCT03451994|Other|Breath test|Breath samples taken from all participants, analyzed with gas chromatography mass spectrometry (GC/MS), no treatment given.
15925819|NCT03451981|Procedure|mechanical debridement and chemical decontamination|mechanical debridement and chemical decontamination: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments and the implant surface will be cleaned by copious irrigation with chlorhexidine.
15925820|NCT03451981|Procedure|Er:YAG laser|mechanical debridement and chemical decontamination: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments and the implant surface will be cleaned by copious irrigation with Chlorhexidine. Furthermore, Er:YAG laser treatment will be provided on the implant surface.
15925821|NCT03451981|Procedure|Air Powder|mechanical debridement and chemical decontamination: Inflammatory tissue, excess cement or plaque deposits will be removed using hand instruments and the implant surface will be cleaned by copious irrigation with Clorhexidine. Furthermore, an Air-Powder treatment will be provided on the implant surface.
15925822|NCT03451968|Other|amino acid tracer injection for metabolism analysis|"the intervention includes injecting stable amino acid tracers in order to evaluate differences in processing of amino acid in critically ill patients compared to a normal population.
~after injection 5 ml of blood will be drawn at time 0, 2, 5, 10, 15, 20, 30, 40, 50, 60, 90, 120, 150, 180 minutes from the start of the study, a total of 14 blood samples (70 cc)."
15925823|NCT03451955|Other|Gluten-free diet|Participants in the intervention group abstain from gluten for 6 months.
15925824|NCT03451942|Drug|FLOT regimen chemotherapy|FLOT regimen chemotherapy
15925825|NCT03451942|Procedure|D2 gastric and imaging metastases resection|After received 4 cycles FLOT regimen chemotherapy , D2 gastric resection and imaging metastases resection was performed. Then continue 4 cycles of FLOT regimen chemotherapy (Chemotherapy begins within 4-6 weeks after surgery)
15925826|NCT03451916|Drug|PLX-PAD|PLX-PAD (120 subjects): 150×10^6 PLX-PAD cells (10×10^6 cells/mL) in a mixture containing 10% DMSO (v/v), 5% HSA (w/v) and PlasmaLyte
15925827|NCT03451916|Drug|Placebo|Arm 2 Placebo (120 subjects): Placebo (solution comprised of 10% DMSO [v/v], 5% HSA [w/v], and PlasmaLyte, without cells).
15925828|NCT03451903|Drug|Actilyse|Actilyse is the intra-venous agent used for intra-venous thrombolysis in the acute phase of cerebral infarction.
15925829|NCT03451903|Procedure|Mechanical thrombectomy|Mechanical thrombectomy is an endovascular procedure by which an arterial clot is retrieved, in order to reperfuse the brain.
15925830|NCT03451890|Drug|E2730|oral capsule
15925831|NCT03451890|Drug|Placebo|oral capsule
15925832|NCT03451877|Genetic|TGFB1 AND LAMA1 GENE POLYMORPHISMS|we evaluated polymorphisms in the LAMA1 (rs2089760) and TGFB1 (rs4803455) genes in children younger than 13 years of age with ≥6 D myopia in an attempt to further elucidate the genetic basis of high myopia.
15925833|NCT03451864|Procedure|Vaginal delivery|classic vaginal delivery
15925834|NCT03451864|Procedure|Cesarean Section|routine lower segment cesarean scetion
15925838|NCT03451838|Diagnostic Test|Ultrasound|Ultrasound will be done to every pregnant lady
15925839|NCT03451838|Diagnostic Test|HbA1c level in blood|a blood sample will be taken to measure HbA1c level
15925840|NCT03451825|Drug|Avelumab|Subjects will receive avelumab administered intravenously (IV) once every 2 weeks.
15925841|NCT03451825|Drug|Avelumab|Subjects will receive avelumab at a recommended phase II dose (RP2D) adjudicated by a safety monitoring committee (SMC) from phase I part of the study.
15925842|NCT03451799|Other|Ketogenic Diet|A 4-month ketogenic diet will be supervised and monitored by the study investigators. Study dietitians will create personalized meal plans for each patient with the goal of achieving and maintaining metabolic ketosis.
15925843|NCT03451799|Radiation|Standard-of-care radiation|Patients will receive standard-of-care radiation. Radiation is not protocol directed.
15925844|NCT03451799|Drug|Standard-of-care Temozolomide|Patients will receive standard-of-care temozolomide. Temozolomide is not protocol directed.
15925845|NCT03451786|Device|IOL|Intraocular lens
15925846|NCT03451773|Drug|M7824|1,200 or 500mg every 2 weeks by intravenous (IV) infusion
15925847|NCT03451773|Drug|Gemcitabine|Standard (1,000 mg/m^2) or reduced (600 mg/m^2 for 4 doses) intravenous (IV) once a week for first 4 weeks. Then, once weekly for 3 weeks with one week rest. Gemcitabine will be discontinued after 6 months of therapy
15925848|NCT03451760|Drug|Feru-guard 100M|Feru-guard is a dietary supplement commercially available in Japan in the form of a 1.5 g instant powder packet that is sold in health clinics and directly by Glovia Co. Ltd to patients on doctor's recommendation. The current study will use Feru-guard in the form of a 280 mg hard gel capsule that contains the same amount of the active ingredients (ferulic acid and Angelica archangelica) as the 1.5 g packets. In order to conduct a double-blind, placebo-controlled trial, Feru-guard is contained in opaque, hard gel capsules which allows for better matching of characteristics and improved blinding than studies using powder. Feru-guard will be supplied by Glovia, Co. Ltd., in Tokyo, Japan.
15925849|NCT03451760|Other|Feru-guard 100M Placebo|In order to conduct a double-blind, controlled trial, the placebo will be contained in opaque, hard gel capsules which allows for better matching of characteristics and improved blinding. The placebo study drug will be matched to the Feru-guard 100M in terms of appearance, smell, and taste.
15925974|NCT03450616|Device|PICO Negative Pressure Wound Therapy|Negative Pressure Wound Therapy Device
15925850|NCT03451734|Drug|antipsychotic medications|olanzapine, risperidone, aripiprazole, amisulpride, ziprasidone, and haloperidol groups
15925851|NCT03451734|Drug|adjunctive group|antipsychotic plus placebo, antipsychotic plus sulforaphane(3 tables per day, consisting of 30 mg of SFN-glucosinolate per day), and antipsychotic plus minocycline(200mg per day) groups.
15925852|NCT03451734|Drug|metformin and lifestyle intervention|different dose metformin combines lifestyle intervention
15925853|NCT03451721|Device|ImageReady™ MR Conditional Defibrillation System|Subject will receive an ICD or CRT-D pulse generator in the left or right pectoral region ICD
15925854|NCT03451708|Device|OKS|Optokinetic stimulation will be displayed on a see-through liquid crystal display lens placed in front of the subjects.
15925855|NCT03451695|Drug|Morphine|Morphine group will receive intrathecal 11 mg of hyperbaric bupivacaine (2.2 mL 0.5%), 10 μg of fentanyl (0.2 ml) and 100 μg of preservative free morphine (0.1 ml).
15925856|NCT03451695|Drug|Placebo|Placebo group will receive 11 mg of hyperbaric bupivacaine (2.2 mL 0.5%), 10 μg of fentanyl (0.2 ml) and normal saline (0.1ml)
15925857|NCT03451682|Dietary Supplement|procyanidine|Natural antioxidant
15925858|NCT03451643|Procedure|ENDOSCOPIC PLACEMENT OF EXPANDABLE STENT|PLACEMENT OF AN ENDOSCOPIC SELF EXPANDABLE METAL STENT
15925859|NCT03451630|Behavioral|High-Touch|Intensive, in-person support.
15925860|NCT03451630|Behavioral|High-Tech|Remote care management and self-directed digital tools.
15925861|NCT03451630|Behavioral|Usual Care/Optimal Discharge Planning|Transition to other Health Plan disease management programs.
15925862|NCT03451617|Device|Stent delivery with Xpedition|Use of Xpedition stent delivery system to implant the XIENCE stent
15925863|NCT03451617|Device|Stent delivery with Alpine|Use of Alpine stent delivery system to implant the XIENCE stent
15925864|NCT03451604|Other|preoperative assessement|All data concerning study, involved in normal care of patient for his anesthesia (non interventional study), where included in anonymous computerized database by anesthesiologist during pre operative clinic.
15925865|NCT03451591|Drug|Isosorbide Mononitrate XL (ISMN)|Isosorbide mononitrate (ISMN), is an NO donating organic nitrate that enhances vasodilation, is widely used in ischaemic heart disease, and has no antiplatelet activity.
15925866|NCT03451591|Drug|Cilostazol|Cilostazol is a phosphodiesterase 3-inhibitor (PDE3-inhibitor) that enhances the PGI2-cAMP system. It has weak antiplatelet effects (so low bleeding risk), reduces infarct size and reduces ageing-related decline in myelin repair in experimental models.
15925867|NCT03451591|Drug|ISMN XL and Cilostazol|Cilostazol is a phosphodiesterase 3-inhibitor (PDE3-inhibitor) that enhances the PGI2-cAMP system. It has weak antiplatelet effects (so low bleeding risk), reduces infarct size and reduces ageing-related decline in myelin repair in experimental models. Isosorbide mononitrate (ISMN), is an NO donating organic nitrate that enhances vasodilation, is widely used in ischaemic heart disease, and has no antiplatelet activity.
15925868|NCT03451591|Other|Neither ISMN nor cilostazol|Neither isosorbide mononitrate nor Cilostazol administered for the entire duration of the study.
15925869|NCT03451578|Device|Alpha MSH assay|Assay to detect levels of alpha MSH in intraocular fluid.
15925870|NCT03451552|Behavioral|Patient Navigator|Navigators will support patients to access community based resources for healthy living and self-management, rather than providing specific information about health issues. Navigators will teach patients how to identify available and relevant programs to meet their health-related goals, in their language of choice. The navigator will ensure that the individual understands the reason for referral and potential benefits. They will discuss social barriers potentially affecting patients' access to community health resources, and assist patients to prioritize their health goals and relevant resources to achieve these. The navigator will then assist patients to access the community-based services in the language of their choice to which they have been referred. The navigator may assist the patient in making appointments, coordinating transportation, and/or accompaniment to resources as required).
15925871|NCT03451526|Procedure|Surgeries|Surgeries plus adjuvant chemotherapies or perioperative chemotherapies
15925872|NCT03451513|Behavioral|Pride Body Project|"PBP is a 2-session eating disorder prevention program. Each session is 2 hours, and separated by a week. Groups have 4 to 7 participants and are led by a peer and a clinician. This program allows a forum for young men to critique the appearance ideal. These exercises should induce cognitive dissonance, which subsequently lead to a reduction of internalization of the ideal. In session 1, participants: (1) define the ideal body type in the gay community, (2) discuss its origin and perpetration, (3) brainstorm its costs, (4) participate in a verbal challenge where they counter the ideal, and (5) are asked to complete three assignments. In session 2, participants: (1) review homework, (2) engage in role-plays to counter pursuit of the ideal, (3) discuss ways to challenge body talk statements, (4) list ways to resist the pressure to pursue this ideal (body activism), (5) discuss barriers to body activism and how to overcome those barriers, and (6) select an exit activity."
15925873|NCT03451513|Behavioral|Media Advocacy|We will use a media advocacy (MA) intervention as an active, time- and attention-matched control. MA is a 2 session, group-based program with co-leaders (1 peer and 1 clinician). The MA content centers on acknowledging and discussing the role the media has on shaping body image ideals. In session 1, there is a discussion on describing the ideal body in the gay community and how the media impacts this ideal. Following this, participants will watch a video on how the media influences body image among gay men, and the consequences of internalizing these messages. In session 2, participants will watch a second video. Next, the group discusses other forms of media (e.g., pornography, social media) and how it impacts body image.
15925874|NCT03451500|Drug|carbidopa-levodopa|See previous
15925875|NCT03451487|Drug|Panadol®|Acetaminophen 500mg Tablet
15925876|NCT03451487|Drug|SafeTynadol®|Acetaminophen 500mg Tablet
15925878|NCT03451461|Other|No intervention|Observational study. Clinical data recorded
15925879|NCT03451448|Diagnostic Test|PET/MRI|PET/MRI with USPIO contrast
15925880|NCT03451448|Diagnostic Test|MRI|MRI with USPIO contrast
15925881|NCT03451435|Drug|N acetyl cysteine|N acetyl cysteine at 20mM will be utilized as the final stage of irrigation prior to induction of bleeding during endodontic revascularization procedure.
15925884|NCT03451409|Other|Tasked based functional MRI (fMRI)|2-3 brief computer tasks while brain activity is being measured. The tasks performed will involve making button press responses to letters, numbers or shapes on the computer screen.
15925885|NCT03451409|Other|Eye Tracking Device|Camera aimed at eyes to record eye movements during tasks
15925886|NCT03451396|Drug|Lifitegrast|All subjects meet dry eye inclusion and will be treated with Lifitegrast gtts BID
15925887|NCT03451370|Drug|Capecitabine|"750 mg/sqm/bid, day 2 to 15; if toxicities grade ≥2 do not occur, pts may subsequently receive capecitabine 1000 mg/sqm/bid, day 2 to 15 starting the second cycle based on investigator's choice.
~To be repeated every 3 weeks (21 days), for a maximum of 8 cycles.
~If no progression occurs, pts will receive maintenance capecitabine (starting at the same dose used at the last cycle of the induction treatment) plus bevacizumab every 3 weeks (21 days), until disease progression, unacceptable toxicity or patient's refusal."
15925888|NCT03451370|Drug|Oxaliplatin|100 mg/sqm iv over 2 hours, day 1 To be repeated every 3 weeks (21 days), for a maximum of 8 cycles.
15925889|NCT03451370|Drug|Bevacizumab|"7.5 mg/kg iv over 90 minutes, day 1; if the first infusion is tolerated, then subsequent infusions may be administered in 30 minutes.
~If no progression occurs, pts will receive maintenance capecitabine (starting at the same dose used at the last cycle of the induction treatment) plus bevacizumab every 3 weeks (21 days), until disease progression, unacceptable toxicity or patient's refusal. To be repeated every 3 weeks (21 days), for a maximum of 8 cycles."
15925890|NCT03451357|Diagnostic Test|Dependence degree already certificated by Dependence Law.|The European Council defines dependence as the state in which people, due to causes linked to the lack or loss of physical, psychological, or intellectual autonomy, are in need of assistance and/or significant help to carry out common activities of daily life. In primary care, the nurses in charge are trained of data collection. This situation needs of formal care provided by health or/and social workers, private or public.
15925891|NCT03451344|Other|Integrated rehabilitation group|Participant in integrated rehabilitation group needs to visit their corresponding social worker and accept illicit drug test every two months. Social worker will help their corresponding client to apply for social benefits accordingly, and provide counseling irregularly if necessary. The integrated rehabilitation group received the standardized community-based rehabilitation described above and simultaneously received a 6-month integrated rehabilitation based on CAREs (Community-based Addiction Rehabilitation Electronic System).CAREs was developed by the department of addiction research in Shanghai Mental Health Center(SMHC), with functions including education, support, psychological intervention and other functions.
15925892|NCT03451344|Other|Community-based rehabilitation group|Participant in community-based rehabilitation group needs to visit their corresponding social worker for six months and accept illicit drug test every two months. Social worker will help their corresponding client to apply for social benefits accordingly, and provide counseling irregularly if necessary.
15925893|NCT03451331|Drug|Nivolumab|Nivolumab 360mg (and/or) Maintenance Single Agent Nivolumab 480mg (starting ~ 2-4 weeks after completing combination chemotherapy plus nivolumab)
15925894|NCT03451331|Drug|Gemcitabine|1000 mg/m^2
15925895|NCT03451331|Drug|Carboplatin|AUC 4.5 (based on the Calvert formula)
15925896|NCT03451331|Drug|Oxaliplatin|130 mg/m^2
15925897|NCT03451318|Drug|Mometasone Furoate Nasal Spray|Mometasone Furoate Nasal Spray NASONEX
15925898|NCT03451318|Procedure|tonsillar adenoidectomy|tonsillar adenoidectomy
15925899|NCT03451318|Procedure|Maxillary expander plus Twin-Block|Twin-block appliance combined with maxillary expander
15925900|NCT03451305|Other|Pillow|A soft pillow was placed under the segment of the collapsed vertebrae, which resulted in a hyperextension position
15925901|NCT03451292|Drug|Albutein 20% Injectable Solution|Within 96 hours after discharge and following randomization, subjects will receive the first Albutein 20% infusion at the dose of 1.5 g/kg body weight (maximum 100 grams per subject). Thereafter, subjects will receive Albutein 20% infusions at the dose of 1.5 g/kg body weight (maximum 100 grams per subject) every 10 ± 2 days for the rest of the study (up to a maximum of 12 months). Subjects in this treatment group will also receive SMT.
15925902|NCT03451292|Other|Standard medical treatment|Subjects will receive SMT according to published guidelines for the management of decompensated cirrhosis.
15925903|NCT03451266|Drug|Vitamin C|1,5g of IV vitamin C in 100 ml 0.9% NaCl within 30 min of delivery and then every 6 hours for the first 72 hours post-partum.
15925904|NCT03451266|Drug|placebo|100 ml of IV 0.9% NaCl within 30 min of delivery and then every 6 hours for the first 72 hours post-partum.
15925905|NCT03451253|Other|amino acid mixture beverage|commercially available amino acid mixture. Contains 5 amino acids, electrolytes and natural flavoring.
15925906|NCT03451253|Other|glucose-based sports drink|Commercially available glucose-based sports drink, contains electrolytes, sugar and artificial flavoring.
15925907|NCT03451240|Behavioral|Corporate Athlete® Resilience|"The product Corporate Athlete® Resilience Training Program (CAR Training), is a one day training program aimed to educate participants about stress management and stress recovery techniques.
~The content of the training program is divided into two parts:
~Introduction to stress and resilience: an overview of stress and its impact on wellbeing, combined with the definition of resilience and its linking to daily performance.
~Introduction and implementation of stress management and resilience techniques: an overview of applicable stress management and resilience tools, combined with real time application methods. These activities aim to help individuals recover and grow from a stressful state into meaningful life engagement. The desired overall effect is better performance at home and at work."
15925908|NCT03451227|Drug|Dexmedetomidine group|The study drug dexmedetomidine (PrecedexTM) will be infused at 0.2-1mcg/kg/hour from the start of the case. The dexmedetomidine infusion will stop at completion of the procedure.
15925909|NCT03451227|Drug|Remifentanil Group|Remifentanil HCL will be infused at 0.01-0.2 mcg/kg/min titrated to sedation level (SAS less than or equal to 4) and cardiovascular parameters (within 30% of baseline). The infusion will be stopped at the end of the procedure.
15925910|NCT03451214|Other|Diet Zinc|4 mg zinc from zinc biofortified wheat, was added to a controlled diet; 25 mg supplemental zinc was given during the final recovery period
15925911|NCT03451201|Behavioral|High Intensity Interval Training|High Intensity Interval Exercise Training in cycle ergometer, exercising at 80% of maximal capacity during one minute alternated with exercise at 50% of maximal capacity during 4 minutes intervals, for a total of 30 minutes. Three times a week for 8 weeks
15925912|NCT03451201|Behavioral|Moderate Continuous Exercise Training|Moderate Continuous Exercise Training 3 times a week for 8 weeks at 50% of maximal capacity
15925913|NCT03451201|Other|Non-exercise|Conventional care for sedentary Type 1 Diabetes Controls. No intervention.
15925914|NCT03451188|Device|Cerecare compression garments|all Cerecare compression garments
15925915|NCT03451162|Drug|DHES0815A|DHES0815A will be administered via intravenous (IV) infusion on Day 1 of each 21-day cycle.
15925916|NCT03451149|Device|Radiofrequency wire (Powerwire)|Using a radiofrequency wire in lieu of a needle for penetrating the liver during transjugular intrahepatic portosystemic shunt creation.
15925917|NCT03451123|Drug|FET PET/MRI|FET PET/MRI scan before and after surgery
15925918|NCT03451110|Drug|lemborexant|oral tablet
15925919|NCT03451110|Drug|Loestrin|oral tablet
15925920|NCT03451110|Drug|famotidine|oral tablet
15925921|NCT03451110|Drug|fluconazole|oral tablet
15925922|NCT03451097|Radiation|echocardiography|cardiac ultrasound
15925923|NCT03451084|Drug|ASLAN003|Patients will be administered with the study drug, ASLAN003. The study drug is to be administered orally, QD or BID. It is recommended to administer the study drug with food or within 30 minutes after food intake.
15925924|NCT03451071|Drug|Gardasil9|Gardasil 9
15925925|NCT03451045|Drug|Lenabasum 20 mg|Subjects will receive lenabasum 20 mg twice daily.
15925926|NCT03451045|Drug|Lenabasum 5 mg|Subjects will receive lenabasum 5 mg twice daily.
15925927|NCT03451045|Other|Placebo|Subjects will receive placebo twice daily.
15925928|NCT03451032|Other|Non Interventional Study|Non Interventional Study
15925929|NCT03451019|Drug|Sevelamer Hydrochloride|Single oral doses of lanthanum (1000 mg) or Sevelamer (2400 mg) were administered in random order 15 minutes after 5 g calcium carbonate with standardized meal
15925930|NCT03451019|Drug|Lanthanum Carbonate|Single oral doses of lanthanum (1000 mg)
15925933|NCT03450993|Other|SMART Program|This is an 8-week, multimodal resiliency program that targets stress with 4 main components: mind-body skills (participants learn a variety of meditation techniques, mini relaxations, walking meditation, and yoga), traditional stress management techniques, healthy lifestyle behaviors (sleep, exercise, nutrition, and social support), and cognitive reappraisal and adaptive coping skills (borrowed from cognitive behavioral therapy, acceptance and commitment therapy, and positive psychology)
15925934|NCT03450980|Other|EyeTurn App|App software which analyzes the position of ocular surface reflections in a photograph to quantify eye misalignment (strabismus)
15925935|NCT03450967|Drug|Durvalumab Plus Tremelimumab|Durvalumab 1500mg plus tremelimumab 75mg via IV infusion Q4W, starting on Week 0, for up to a maximum of 4 doses/cycles followed by durvalumab monotherapy 1500mg via IV infusion Q4W, starting 4 weeks after the last infusion of the combination until progression.).
15925936|NCT03450954|Procedure|Amniotic membrane transplant|Amniotic membrane graft was transplanted onto the bullous cornea by the inlay technique
15925937|NCT03450928|Procedure|Peroral Endoscopic Myotomy (POEM)|"Peroral endoscopic myotomy (POEM) is a minimally invasive intervention for the treatment of esophageal achalasia.
~POEM includes different steps:
~Lifting of the esophageal mucosa, with the injection of saline solution, and mucosal incision on the esophageal body (approximately 12 or 7 cm above the esophagogastric junction, for about 1-2cm)
~Advance of the endoscope into the submucosa, repeated submucosal injection and dissection of a submucosal tunnel into the distal esophagus up to 3 cm into the gastric wall.
~Myotomy of the distal esophagus, cardia and gastric wall, starting 3 cm below the mucosal incision
~After the completion of myotomy, and check for mucosal integrity, the mucosal incision is closed using endoscopic clips"
15925938|NCT03450915|Biological|M-001|A recombinant protein containing 9 conserved epitopes from Influenza A and B that are common to the vast majority of influenza viruses.
15925939|NCT03450915|Biological|Saline|0.9% sodium chloride (NaCl)
15925940|NCT03450902|Combination Product|Chinese herb & acupuncture|Participants will take Chinese herbal formula, Yiqi Suoquan granule, which is composed of Radix Astragali 30 g, Radix Codonopsis pilosula 10g, Radix Angelica sinensis 10g, Radix Atractylodis Macrocephalae 10g, Fructus Alpiniae Oxyphyllae 10g, Radix Lindera aggregata 6g, Rhizoma Dioscoreae 10g, pericarpium citri reticulatae 10g, Rhizoma Cimicifuga 10g, Radix Bupleuri 10g, Fructus Rubi 15g, and Semen raphani 10g and prepared by the Department of Pharmacy, Guang'anmen Hospital, China Academy of Chinese Medical Sciences. Besides, Participants will receive acupuncture, three times a week. The selected acupoints include bilateral BL33, BL35, SP6, and ST36.
15925941|NCT03450902|Combination Product|Chinese herb & sham acupuncture|Participants will take Chinese herbal formula, Yiqi Suoquan granule, which is composed of Radix Astragali 30 g, Radix Codonopsis pilosula 10g, Radix Angelica sinensis 10g, Radix Atractylodis Macrocephalae 10g, Fructus Alpiniae Oxyphyllae 10g, Radix Lindera aggregata 6g, Rhizoma Dioscoreae 10g, pericarpium citri reticulatae 10g, Rhizoma Cimicifuga 10g, Radix Bupleuri 10g, Fructus Rubi 15g, and Semen raphani 10g and prepared by the Department of Pharmacy, Guang'anmen Hospital, China Academy of Chinese Medical Sciences. Besides, Participants will receive sham acupuncture, three times a week. The sham BL33, BL35, SP6, and ST36, which are 25 mm outward to BL33, BL35, SP6, and ST36, will be inserted with a depth of 2 to 3 mm.
15925942|NCT03450902|Combination Product|Placebo & acupuncture|Participants will take Chinese herbal placebo which is prepared by the Department of Pharmacy, Guang'anmen Hospital, China Academy of Chinese Medical Sciences. Besides, Participants will receive acupuncture, three times a week. The selected acupoints include bilateral BL33, BL35, SP6, and ST36.
15925943|NCT03450902|Other|Placebo & sham acupuncture|Participants will take Chinese herbal placebo which is prepared by the Department of Pharmacy, Guang'anmen Hospital, China Academy of Chinese Medical Sciences. Besides, Participants will receive sham acupuncture, three times a week. The sham BL33, BL35, SP6, and ST36, which are 25 mm outward to BL33, BL35, SP6, and ST36, will be inserted with a depth of 2 to 3 mm.
15925944|NCT03450889|Procedure|Colonoscopy|"Patients will undergo surveillance colonoscopies, with intervals of 1 or 2 years depending on the amount and type of polyps resected during last colonoscopy.
~In case patients underwent subtotal colectomy, the term 'colonoscopy' should be replaced with 'sigmoidoscopy'."
15925945|NCT03450876|Other|Non-Interventional|Non-Interventional
15925946|NCT03450863|Drug|Fast-acting insulin aspart|Patients will be treated with commercially available fast-acting insulin aspart as bolus insulin (multiple daily injection [MDI]) or as insulin used in the insulin pumps (continuous subcutaneous insulin infusion [CSII]). Dosing of fast-acting insulin aspart is individual and determined by the treating physician in accordance with the needs of the patient.
15925947|NCT03450850|Device|NOVOTTF-200A|NOVOTTF-200A will be administered under appropriate guidelines. Monthly adherence rate >= 75% (>= 18 hours/day) over a 4-week cycle (28 days) will be strongly encouraged.
15925948|NCT03450837|Diagnostic Test|Coronary Computed Tomography Angiography|To assess coronary artery plaque and calcification, all participants underwent coronary computed tomography angiography according to the guidelines of the Society of Cardiovascular Computed Tomography (SCCT). All CT scans were acquired in a 320-row detector scanner (AquillionOneTM - Toshiba Medical Systems Corporation, Otawara, Japan) with 0.5-mm thick slices. Acquisition protocol included coronary artery calcium scoring (CACS) and coronary CTA. CACS protocol utilized a 370-ms tube rotation, 120-kV tube voltage, 300-mA tube current, and 320x0.5-mm collimation with 3-mm slice thickness reconstructed images, one heart beat acquisition during diastole.
15925949|NCT03450837|Diagnostic Test|Macrophage cholesterol efflux mediated by HDL|Macrophages were incubated with DMEM (Low Glucose, Gibco, Grand Island, New York, USA) containing 1 mg fatty acid free albumin (FAFA) (Sigma-Aldrich, Steinheim, Germany) plus 50 μg acetylated LDL/mL and 0.3 μCi 14C-cholesterol/mL (Amersham Biosciences, UK) for 48h. After washing with PBS/FAFA, cells were incubated in the presence or absence of HDL (50 µg/mL) for 8h. The amount of radioactivity present in the medium at the end of the HDL incubation period will indicate albumin-mediated cholesterol efflux with albumin alone and total efflux with albumin + HDL. Thus, specific HDL-mediated efflux will be calculated, subtracting the albumin-mediated efflux from total efflux
15925950|NCT03450824|Other|No intervention|The standardized standing whole-lower-extremity radiographs, the knee lateral view and skyline view of the participants will be taken.
15925951|NCT03450811|Procedure|Inguinal hernia repair|Lichtenstein procedure or laparoscopic method (Total extraperitoneal) inguinal hernia repair
15925952|NCT03450798|Device|SOFT block group|needle will be introduced medial to the femoral vein and 3 cm below the skin where 15 mL of bupivacaine 0.25% injected. the obturator nerve, the probe shifted medially, superior to the needle, and directed cranially to the pectineus muscle . Needle withdrawn to the subcutaneous tissue and redirected using out-of-plane toward the deep surface of pectineus, 10 mL of bupivacaine 0.25%will be injected. The sciatic nerve, we use the curvilinear probe, inferior to the needle, and tilted the probe to get the clearest image of the sciatic nerve.The needle will be inserted then withdrawn subcutaneously and directed by an in-plane toward the sciatic nerve deep to the inferior border of the quadratus femoris muscle.20 mL of bupivacaine 0.25% will be injected
15925953|NCT03450798|Device|spinal anesthesia group|patients will receive spinal anesthesia with hyperbaric bupivacaine 0.5% (7.5-10mg). This will be administered via a 25-G spinal needle at L4-L5 or L3-L4 with the patient in the sitting position under complete aseptic conditions.
15925954|NCT03450785|Other|ultrasound examination|Doppler ultrasound examinations from the thyroid cartilage level to the supraclavicular region were used after CVC placement and on each of the following days until the catheter was removed.
15925955|NCT03450772|Drug|Creon® 25000|Experimental drug
15925956|NCT03450772|Drug|Creon® 10000|Active comparator
15925957|NCT03450759|Drug|AZD9977 Oral suspension (reference)|Randomized subjects will receive single oral dose of AZD9977 oral suspension 15 mg/mL on Days 1, 3, 5 and 7 in Part A.
15925958|NCT03450759|Drug|AZD9977 capsule|Randomized subjects will receive single oral dose of AZD9977 capsule 65 mg on Days 1, 3, 5 and 7 in Part A.
15925959|NCT03450759|Drug|AZD9977 ER capsule (fastvrate)|Randomized subjects will receive single oral dose of AZD9977 ER capsule (fast rate) 65 mg on Days 1, 3, 5 and 7 in Part A.
15925960|NCT03450759|Drug|AZD9977 ER capsule (Int. rate)|Randomized subjects will receive single oral dose of AZD9977 ER capsule (Int rate) 65 mg on Days 1, 3, 5 and 7 in Part A.
15925961|NCT03450733|Device|Wright Medical Technology Metal-on-Metal Total Hip System|Subjects in Group 1 previously implanted prior to the study start date will be identified from Investigator records. Collected data will be evaluated in aggregate and cross-sectioned by year of implantation. Subjects will be cross-sectioned by the time that has elapsed between implantation and the initial visit (e.g. 5 years, 6 years) using contiguous visit windows (number of years + 6 months). Subject data will be grouped in order to create cross-sectional epochs of ≤ 8 years and > 8 years.
15925962|NCT03450720|Drug|GLPG2737 single dose|GLPG2737 oral suspension, single dose
15925963|NCT03450707|Drug|Thiamine 500 mg IV|Thiamine hydrochloride (vitamin B1) 500mg IV will be given every 12 hours for 5 doses in the experimental arm.
15925964|NCT03450707|Other|Placebo|100mL of intravenous normal saline will be given every 12hours for 5 doses in the placebo arm
15925965|NCT03450694|Device|ultrasound|ultrasound is a non-invasive and not expensive method, availiable at almost all institutions.
15925966|NCT03450681|Procedure|Pulsed radiofrequency of the saphenous nerve before knee replacement surgery|A trained anesthesiologist and pain clinician performs ultrasound guided pulsed radiofrequency on the saphenous nerve of a patient undergoing knee replacement surgery, prior to the beginning of the surgical act.
15925967|NCT03450681|Procedure|Mock incision|A trained anesthesiologist and pain clinician performs a mock incision on the pulsed radiofrequency needle insertion site
15925968|NCT03450668|Device|mOm incubator|24 hour usage of test incubator
15925969|NCT03450668|Device|standard incubator|standard incubator
15925970|NCT03450655|Other|10-week aerobic exercise program|An aerobic exercise program consisting of 45-60 minute sessions 3 times a week for 10 weeks.
15925971|NCT03450642|Other|Observational|Complement cascade components C3, C4, iC3b and TCC serum concentrations were measured over the time course from t= admission, 4,8,12,23,47,71 hours or until discharge.
15925972|NCT03450629|Drug|Brimonidine Tartrate Ophthalmic Suspension|Brimonidine Tartrate Ophthalmic Suspension
15925973|NCT03450629|Drug|Brimonidine Tartrate Ophthalmic Solution|Three Times Brimonidine Tartrate Ophthalmic Solution
15925976|NCT03450577|Procedure|PCI of bifurcation lesions|Different approaches for treatment of bifurcation coronary artery disease.
15925977|NCT03450564|Behavioral|Women Education|This intervention intends to provide health education message for women enhance FP utilization in pastoralist community. It was cognizant that, Ethiopia is the second most populous country in Africa. And there is a great discrepancy between contraceptive use, unmet need for FP and maternal and child morbidity and mortality between the pastoralist and agrarian community. Pastoralist community in the country expressed as low contraceptive users, a high unmet need for FP and highest maternal and child morbidity and mortality. The previous study indicates that only 5.4% of the women use contraceptive. The most common reason mentioned for not using of contraceptive are lack of awareness, demand for a large number of children and male dominance in all decision making power in general and FP in particular. In light of this, the study hypothesized that working with men and educating women towards the use of FP could enhance the use of family planning utilization.
15925978|NCT03450564|Behavioral|Male Involvement|Male involvement was a feature of intervention in this arm. Comprehensive health education about FP was given in addition to the video message about FP. In pastoralist community the most reason mentioned for not using of FP are husband objection and religion influence. And most of the decisions are in the palm of husband to seek care for reproductive, maternal and neonatal health in general and FP in particular. Besides, the pastoralist community manifested by high total fertility rate and maternal and child morbidity and mortality.
15925979|NCT03450564|Other|Control group|The third group in this community based intervention was following the community without provision of male iand married women education. In this group there was no intervention by the researchers. However, the activities performed by the government about family planning provision was maintained.
15925980|NCT03450551|Device|Twin Block, Herbst, Frog distalising appliance|To study which of the three orthodontic appliances does achieve the best clinical progress, produce least discomfort to the patient, minimize the time taken for completion of treatment and maximize compliance.
15925981|NCT03450525|Other|No intervention|No intervention
15925982|NCT03450512|Other|prospective study on digestive affections in an homogeneous cohort of hematological patients|"Systematic realization during the induction and/or every consolidation of a CTscan with injection, at the same time as the thoracic CTscan (to research an invasive fungal bronchopulmonary infection), in front of a febrile neutropenia with persistent fever after 5 days of antibiotics and presence of digestive signs.
~Statement of the information characterizing the digestive affection: clinical symptoms, microbiological, characteristic, realized additional explorations, infectious complications and specific therapeutics.
~The abdominal scanner will be repeated in case of suspicion of complication or clinical worsening. In case of EC, the abdominal scanner will be realized before beginning the next cycle of AML treatment to evaluate digestive remission. Finally, a CT scan, will be performed when digestive disease, digestive neoplasia or digestive symptoms are noted at AML diagnosis."
15925983|NCT03450499|Drug|Ketamine|the analgesic affects of ketamine will be compared between the experimental and placebo group.
15925984|NCT03450499|Drug|Placebo|the analgesic requirement will be calculated in placebo group.
15925985|NCT03450486|Other|exercise|one 30 minute bout of mild exercise
15925986|NCT03450473|Device|SurgiMend® MP|SurgiMend MP® is an acellular dermal tissue matrix derived from bovine dermis. The device is supplied sterile in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs. SurgiMend MP® will be used for abdominal wall reinforcement in patients with complex ventral hernia repair.
15925987|NCT03450460|Behavioral|Peer support|The Program matches volunteer Mentors and Partners for a series of one-to-one interactions that focus on the discussion and resolution of problems or issues (i.e., problem solving) related to one or several key topic areas including family and friends, resources, life changes or challenges, (health care) professionals, social/recreational activities, work/employment/training/volunteering, the brain injury itself, emotions or feelings, and other issues.27 Once the match is established, the Mentor and Partner communicate with one another primarily by telephone until the problems or issues are either resolved or a referral to another service is made (i.e., counselling or community support services). For some partnerships, communication by email or video conferencing is used.27 Most telephone calls last between 20 and 40 minutes (personal communication) and are held weekly.
15925988|NCT03450434|Drug|XC8 Oral Tablet|1 tablet of XC8 in a dose according to the treatment group + 2 tablets of placebo (in total 3 tablets) once daily in the morning during 12 weeks of treatment period.
15925989|NCT03450434|Drug|Placebo Oral Tablet|Placebo (in total 3 tablets) once daily in the morning during 12 weeks of treatment period.
15925990|NCT03450421|Device|Actamax™Adhesion Barrier|Actamax™Adhesion Barrier is a degradable hydrogel to be sprayed directly on surgically traumatized tissue. The aim of using the Actamax™ Adhesion Barrier (AB) in this way is to allow damaged and apposing tissue surfaces the opportunity to heal separately without becoming abnormally attached.
15925991|NCT03450408|Procedure|Method of placement of Foley bulb transcervical dilator|This trial will assess two methods used to place a Foley bulb transcervical dilator.
15925992|NCT03450395|Other|Hot Cereal|Intervention involves consumption of one hot cereal in the beginning of each day
15925993|NCT03450382|Other|Hans Kai Education|9 weeks of health education classes preceding social group formation into Hans Kai. Peer led support focused on behavioural change.
15925994|NCT03450369|Biological|NB01|Use an existing therapy designed to kill existing facial bacterial followed by populating facial skin with a single application of NB01
15925995|NCT03450343|Drug|Oral azacitidine|Azacitidine can be taken with or without food at the same time every day.
15925996|NCT03450343|Drug|R-ICE|R-ICE is approved for the treatment of NHL before ASCT for relapsed or primary refractory diffuse large b-cell lymphoma. R-ICE consists of rituximab, etoposide, carboplatin and ifosfamide. R-ICE will be administered per institutional guidelines.
15925997|NCT03450330|Drug|AZD4205|Daily dose of AZD4205, followed by daily dose of AZD4205 and Osimertinib 80 mg. Starting dose of AZD4205 at 75 mg, administered once daily. If tolerated, subsequent cohorts will test increasing doses of AZD4205, and in combination with Osimertinib 80 mg.
15925998|NCT03450317|Drug|Aspirin 80mg|No treatment
15925999|NCT03450291|Other|Volatility task|Participants complete a volatility task, with pupillometry; and a Wisconsin Card Sort Task.
15926074|NCT03449758|Drug|SARILUMAB|Pharmaceutical form:Solution for injection in pre-filled syringe Route of administration: Subcutaneous
15926000|NCT03450278|Procedure|micro-osteoperforation|Minor surgical procedure including performance of limited and shallow perforations of the cortical plate of bone to increase the expression of inflammatory cytokines, hence accelerating orthodontic tooth movement.
15926001|NCT03450265|Device|Hemopatch|Applied according to the current instruction for use (IFU). According to the IFU, a maximum of 7 Hemopatch 45 x 90 mm patches can be used in adults.
15926002|NCT03450265|Device|Tachosil|Applied according to the current instruction for use (IFU).
15926003|NCT03450252|Device|Active pacing|Ventricular pacing via the invasive haemodynamic study-defined optimal pacing site in order to relieve pressure gradient across the mid-cavity obstruction in mid-cavity obstructive variant hypertrophic cardiomyopathy.
15926004|NCT03450252|Device|Back-up pacing|Back-up pacing. The pacemaker is set-up to sense and pace only in the right atrium (AAI) without any pacing capacity in the ventricle.
15926005|NCT03450239|Other|MRI|MRI scan, including structural imaging, functional imaging (both task-related and structural), and Magnetic Resonance Spectroscopy.
15926006|NCT03450226|Drug|stellate ganglion block|After induction of general anesthesia, patients will receive a stellate ganglion block using a standard and well described paratracheal technique, The patient's head will be extended and a 4-5-cm, 22-gauge needle inserted at the medial edge of the sternocleidomastoid muscle just below the level of the cricoid cartilage at the level of the transverse process of C6 or C7. After advancing to the transverse process the needle will be withdrawn 2-3 mm prior to injection. A negative aspiration test will be performed in two planes before a 1-ml test dose is used to exclude unintentional intravascular injection (vertebral or subclavian arteries) or subarachnoid injection into the dural sleeve.4 A total of 10 ml of 0.25% bupivacaine will be injected.
15926007|NCT03450213|Device|Pentacam|Pentacam will be used to measure the magnitude and axis orientation of anterior and posterior corneal astigmatism.
15926008|NCT03450200|Other|exercises for diabetic peripheral neuropathy|Hands, fingers, and foot exercises for diabetic peripheral neuropathy to improve activities of daily living, and decreases the signs and symptoms of DPN
15926009|NCT03450200|Other|Health education for diabetic foot care|Health education for daily diabetic foot care to prevent diabetic foot ulcer was provided.
15926010|NCT03450187|Drug|TP-271|multiple oral doses of TP-271 or placebo, randomized 6:2, doses escalating 50 mg, 100 mg, 200 mg, 300 mg, 400 mg once daily for 7 days.
15926011|NCT03450174|Dietary Supplement|Placebo|In control group, participants will receive only a placebo product
15926012|NCT03450174|Behavioral|Formative messgaes|In this group, participants will only receive daily formative messages
15926013|NCT03450174|Dietary Supplement|Fortified product|In this group, participants will receive fortified product on alternate day up till 8 months
15926014|NCT03450174|Combination Product|Fortified product plus|In this group participants will receive fortified product on alternate day and formative messages up till 8 months
15926015|NCT03450161|Drug|Fentanyl dosing schemes|We routinely use fentanyl as the opioid of choice in CABG surgery. However, how much and whether or not to apply it in boli or continuously remain uncertain. We will apply 3 routinely used fentanyl dosing schemes in our hospital. To blind care-givers and patients, in each of the arms a bolus and a continous injection will occur, as delineated in the treatment arms.
15926016|NCT03450148|Other|Pavlok wristband with electric stimulus|it is a device for various behavior modifications in the form of wristband which participants will wear on the wrist. Device has maximum voltage of 0-500 volts, delivers a electric stimulus for a maximum of 1 sec and average duration of 0.2 secs
15926017|NCT03450148|Other|Pavlok wristband without electric stimulus|it is a device for various behavior modifications in the form of wristband which participants will wear on the wrist. Participants will not receive any electric stimulus since this feature will be turned off.
15926018|NCT03450135|Behavioral|Trier Social Stress Test|Participants will perform an acute psychosocial stress manipulation (Trier Social Stress Test) involving a speech task and challenging mental arithmetic.
15926019|NCT03450135|Behavioral|Emotional go/no-go task|Participants will perform an emotional go/no-go paradigm to examine electrophysiological (EEG) correlates of cognitive and affective processing.
15926020|NCT03450122|Biological|Aldesleukin|Given SC
15926021|NCT03450122|Biological|Autologous NY-ESO-1-specific CD8-positive T Lymphocytes|Given IV
15926022|NCT03450122|Drug|Cyclophosphamide|Given IV
15926023|NCT03450122|Biological|Dendritic Cell-targeting Lentiviral Vector ID-LV305|Given ID
15926024|NCT03450109|Drug|LY01005|One gluteal IM injection
15926025|NCT03450109|Drug|Zoladex|One Subcutaneous injection in the abdominal wall
15926027|NCT03450083|Drug|Benralizumab|30mg Benralizumab will be delivered subcutaneously
15926028|NCT03450083|Drug|Placebo|Subcutaneous placebo injection
15926029|NCT03450070|Device|Light Therapy Mask Cream|test panel
15926030|NCT03450057|Drug|Daratumumab|"Daratumumab will be given at a dose of 16 mg/kg administered as an IV infusion at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Subjects will receive pre-infusion medications before infusions to mitigate potential IRRs
~Drug: Dexamethasone
~Dexamethasone will be administered at 40 mg (20 mg for patients >75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle"
15926031|NCT03450044|Biological|Dendritic cells|Adoptive transfer of autologous DCs
15926032|NCT03450031|Other|NAC (no drug/no device)|Nasal allergen challenge (NAC) with mixed grass pollen: a bolus NAC with mixed grass pollen will be conducted
15926033|NCT03450018|Drug|SLC-0111|Oral SLC-0111
15926034|NCT03450018|Drug|Gemcitabine Injection|1000 mg/m^2 IV
15926035|NCT03449992|Dietary Supplement|nitrate-rich beetroot juice|Nitrate-rich beetroot juice supplementation was administered for 15 consecutive days to participants in this arm
15926036|NCT03449992|Dietary Supplement|Placebo|Placebo drink
15926037|NCT03449979|Device|XCSITE100 Stimulator Sham|The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.
15926038|NCT03449979|Device|XCSITE100 Stimulator tACS|Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.
15926039|NCT03449966|Device|Confocal group|Under pCLE, target biopsy at cancer lesion will be done. 5 pieces of forcep biopsy will be obtained.
15926040|NCT03449966|Device|Control group|Random biopsy around cancer lesion will be done under WLE. 5 pieces with forcep biopsy will be obtained.
15926041|NCT03449940|Procedure|Immediate repair|
15926042|NCT03449940|Procedure|Delayed repair|
15926043|NCT03449940|Drug|Lidocaine|10cc of Lidocaine 1% is used to inject at the base of the penis for a dorsal penile nerve block for the localized repair.
15926044|NCT03449940|Drug|Ceftriaxone|Pre-operative antibiotic given to all patients. Ceftriaxone 1g is administered intravenously.
15926045|NCT03449940|Drug|Diclofenac Sodium|Oral Diclofenac Sodium 50mg tablet is prescribed to be taken as needed up to a maximum of three times daily until the penis is repaired.
15926046|NCT03449927|Other|Specialized menu|-Specialized menu that will guide participant food choices if the participant experiences nausea or diarrhea
15926047|NCT03449927|Other|Standard of care menu|-Standard registered dietitian support
15926048|NCT03449927|Other|Self report dietary intake worksheet|-Self report nausea and diarrhea
15926049|NCT03449927|Other|Post study questionnaire|-Completed upon count recovery and prior to discharge
15926050|NCT03449901|Drug|pegylated arginine deiminase|-Arginine deiminase (ADI) is a recombinant protein cloned from M. hominis, produced in E. coli, and conjugated with PEG of 20,000 mw using a succinimidyl succinate linker. Thus ADI-PEG 20 is an arginine degrading enzyme, ADI, coupled to PEG.
15926051|NCT03449901|Drug|Gemcitabine|-Gemcitabine is a nucleoside metabolic inhibitor that exhibits antitumor activity.
15926052|NCT03449901|Drug|Docetaxel|-Docetaxel is an antineoplastic agent belonging to the taxoid family. It is prepared by semisynthesis beginning with a precursor extracted from the renewable needle biomass of yew plants.
15926053|NCT03449901|Procedure|Tumor biopsy|"Up to 21 days prior to initiation of ADI-PEG 20 Day -1 (+/- 1 day as long as performed prior to initiation of gemcitabine.
~Tumor biopsies are mandatory for the first 20 patients amendable to biopsy enrolled at Washington University only (completed as of 05/14/2019) and for all patients enrolled to the SCLC cohort"
15926054|NCT03449901|Procedure|Research blood draw|-Day -7 (pre-treatment), Day -1, and Days 1 and 8 of each cycle
15926055|NCT03449888|Procedure|Regadenoson myocardial perfusion imaging stress test|Best fit model of pharmacologic myocardial perfusion imaging data, including summed stress and difference scores, gated left ventricular ejection fraction, transient ischemic dilatation, and heart rate response to regadenoson data.
15926056|NCT03449888|Procedure|Arm exercise electrocardiographic stress test|Published arm exercise score and best fit model of arm exercise ECG stress testing data.
15926057|NCT03449888|Procedure|Treadmill electrocardiographic stress test|Duke Treadmill Score and best fit model of treadmill exercise ECG stress testing data.
15926058|NCT03449888|Procedure|Coronary artery calcium score and cardiac computed tomographic angiography|Coronary artery calcium score by Agatston criteria and severe obstructive coronary artery disease > 70% by cardiac computed tomographic angiography or invasive coronary arteriography.
15926059|NCT03449875|Device|TREOVANCE® Stent-Graft with Navitel® Delivery System|Endovascular repair of abdominal aortic aneurysms.
15926060|NCT03449862|Other|Simulation-based clinical decision on brain CT ordering|Clinicians asked to make decision on medical imaging for their simulated patient after presentation of clinical case then additional information. At each presentation of new information the clinician may modify their image order.
15926061|NCT03449849|Other|Base Diet|Base Diet
15926062|NCT03449849|Other|Kale Treatment|Base Diet plus Kale
15926063|NCT03449836|Combination Product|Streptococcus salivarius 24SMBc + Strept. oralis 89a|nasal spray based on Streptococcus salivarius 24SMBc + Strept. oralis 89a
15926064|NCT03449836|Combination Product|fluticasone + mometasone|nasal spray based on fluticasone + mometasone
15926065|NCT03449836|Other|placebo|nasal spray based on isotonic solution
15926066|NCT03449823|Diagnostic Test|Doppler ultrasound of fetal renal artery|Doppler ultrasound assessment of the proximal fetal renal artery to with measurement of the peak systolic velocity, resistive index, pulsatility index, and systolic/diastolic ratio.
15926067|NCT03449810|Procedure|DSE plus MET group A|"The Dynamic stabilization exercises will consist of seven exercises, which are aimed to strengthen the lumbar stabilizing muscles. All seven dynamic stabilization exercises will be performed once and always in random order.
~The procedure for MET involves voluntary contraction of the participant's muscle in a precisely controlled direction, at varying levels of intensity, against a distinctly executed counterforce applied by the therapist. In this type of therapy, a participant contracts muscles by pushing against resistance provided by the therapist. The therapist then assists the participant in stretching, strengthening and relaxing those muscles."
15926068|NCT03449810|Procedure|DSE alone group B|The DSE in this arm is the same a described in group A, i.e. it involves seven exercises activities administered randomly at every session of the study intervention.
15926069|NCT03449810|Procedure|Standard Physiotherapy treatment group C|In the control group, the participants will receive standard physiotherapy treatment offered for the management of chronic NSLBP patients in Nigeria. Therefore, individuals randomized to this therapeutic group will be treated with classical massage, therapeutic exercises and a combination of interferential therapy and therapeutic ultrasound (INF/UTS) applied to the lumbosacral region.
15926070|NCT03449797|Procedure|AVS performed with no intraprocedural rapid cortisol assay|AVS performed plus intraprocedural rapid cortisol assay
15926071|NCT03449797|Procedure|AVS performed plus intraprocedural rapid cortisol assay|Adrenal vein sampling performed according to usual clinical practice without intraprocedural rapid cortisol assay
15926072|NCT03449784|Other|Detection of patients with dyslipidemia|Detection of patients with dyslipidemia
15926073|NCT03449771|Other|self-administered questionnaire|The newsletter and a self-questionnaire will be systematically given in the waiting room to any PrEP consultant to evaluate the consumption of psychoactive substances (ASSIST questionnaire) and to identify anxio-depressive disorders (HAD questionnaire - Hospital Anxiety and Depression). scale).
15958660|NCT03198026|Drug|Obinutuzumab|Given IV
15926076|NCT03449758|Drug|Chloroquine|Pharmaceutical form:Tablet Route of administration: Oral
15926077|NCT03449758|Drug|Hydroxychloroquine|Pharmaceutical form:Tablet Route of administration: Oral
15926078|NCT03449758|Drug|Leflunomide|Pharmaceutical form:Tablet Route of administration: Oral
15926079|NCT03449758|Drug|Methotrexate|Pharmaceutical form:Solution for injection Route of administration: Subcutaneous / Intramuscular
15926080|NCT03449758|Drug|Sulfasalazine|Pharmaceutical form:Tablet Route of administration: Oral
15926081|NCT03449732|Device|PDR measurement|"PDR measurement at two standardized times perioperatively:
~Anesthetized subject by sevoflurane sedation until a minimum alveolar concentration (MAC) of at least 1,5 is reached
~Administration of fentanyl 2µg/kg, in the absence of adjustments in sedation depth"
15926082|NCT03449719|Radiation|SBRT - Ablative radiation Therapy|"The current phase II randomized trial,Ablative Radiation Therapy in patients with Oligometastatic castration resistant prostate cancer (ARTO trial) aims to evaluate the difference in PSA response rate between the experimental arm (AA+SBRT) and control arm (AA) in metastatic castration-resistant prostate cancer patients."
15926083|NCT03449719|Drug|Abiraterone Acetate|systemic treatment with abiraterone acetate 1000 mg daily and prednisone 10 mg daily, plus GnRH agonist or antagonist
15926085|NCT03449693|Dietary Supplement|Magnesium Oxide Supplement|Magnesium Oxide tablet
15926088|NCT03449667|Device|Cryoneurolysis|Cryoneurolysis of the femoral and sciatic nerves (or their distal counterparts) in the residual limb: The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation separated by 1-minute defrost periods. For active probes, the nitrous oxide will be deployed to the tip where a drop in temperature to -70°C will result in cryoneurolysis.
15926089|NCT03449667|Device|Sham Comparator|Sham cryoneurolysis of the femoral and sciatic nerves (or their distal counterparts) in the residual limb: The cryoneurolysis device will be triggered using 3 cycles of 2-minute gas activation separated by 1-minute defrost periods. However, for sham probes, the nitrous oxide is not deployed to the tip and therefore there is no drop in temperature resulting in cryoneurolysis.
15926090|NCT03449654|Drug|Liraglutide|Liraglutid
15926091|NCT03449654|Drug|Placebo (for liraglutide)|Placebo (for liraglutide)
15926092|NCT03449641|Device|Positive airway pressure (PAP)|Positive airway pressure (PAP) is a mode of respiratory ventilation used in the treatment of sleep apnea.
15926093|NCT03449628|Dietary Supplement|L.casei DG|"(At least 24 billion live cells per capsule)
~1 capsule, b.i.d. for 12 weeks"
15926094|NCT03449628|Dietary Supplement|PLACEBO|1 capsule, b.i.d. for 12 weeks
15926095|NCT03449602|Device|Mini-thoracoscopy|Thoracoscopic pleural biopsy with the mini-thoracoscope
15926096|NCT03449602|Device|Conventional rigid thoraoscopy|Thoracoscopic pleural biopsy with the conventional rigid thoraoscope
15926097|NCT03449576|Other|Trauma Management Therapy|Trauma Management Therapy (TMT) consists of a combination of 12 sessions of individualized exposure therapy and 24 sessions of group-based social and emotion rehabilitation.
15926098|NCT03449576|Other|Exposure Therapy with Psychotherapy group|Exposure Therapy with Psychoeducation (EXP+EDU) consists of a combination of 12 sessions of individualized exposure therapy and 24 session of group-based psychoeducation.
15926099|NCT03449563|Combination Product|Open TPVB|In Group E,the thoracic paravertebral block was performed under the direct vision with 0.25% ropivacaine 30 ml,and the Patient-controlled intravenous analgesia was administer after the surgery.
15926100|NCT03449563|Combination Product|Ultrasound-guided TPVB|In Group U, thoracic paravertebral block was performed on the operated side under ultrasound guidance with 0.25% ropivacaine 30 ml,and the Patient-controlled intravenous analgesia was administer after the surgery.
15926101|NCT03449563|Other|placebo|In Group G,patients were just received Patient-controlled intravenous analgesia after the surgery.
15926102|NCT03449550|Other|Home Respiratory Polygraphy (HRP)|Randomizing to start with home respiratory polygraphy
15926103|NCT03449550|Other|Standard Polysomnography (PSG)|Randomizing to start with Standard Polysomnography (PSG)
15926104|NCT03449550|Other|Home Respiratory Polygraphy (HRP)|Randomizing for therapeutic decision taken with home respiratory polygraphy (HRP)
15926105|NCT03449550|Other|Standard Polysomnography (PSG)|Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)
15926106|NCT03449537|Dietary Supplement|extensively hydrolyzed casein formula + LGG|Hypoallergenic formula based on extensively hydrolyzed casein supplemented with the probiotic Lactobacillus rhamnosus GG
15926107|NCT03449537|Dietary Supplement|Hypoallergenic formula based on amino-acid based formula|Hypoallergenic formula for cow milk allergy treatment based on amino acids
15926108|NCT03449524|Drug|75mg CXA-10|CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitro-oleic acid (OA-NO2)
15926109|NCT03449524|Drug|150mg CXA-10|CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitro-oleic acid (OA-NO2)
15926110|NCT03449524|Other|Placebo|Placebo
15926111|NCT03449511|Other|Ginger aromatherapy|Three sniffs of aromatherapy inhaler four times daily for seven days.
15926112|NCT03449511|Other|Orange aromatherapy|Three sniffs of aromatherapy inhaler four times daily for seven days.
15926113|NCT03449511|Other|Lavender aromatherapy|Three sniffs of aromatherapy inhaler four times daily for seven days.
15926114|NCT03449511|Other|Jojoba aromatherapy|Three sniffs of aromatherapy inhaler four times daily for seven days.
15926161|NCT03449134|Drug|Placebo|Participants receive dose-matched placebo tablets orally BID during the 12-week main study period and during the 40-week extension period.
15926162|NCT03449134|Drug|Gefapixant|Gefapixant 15 mg or 45 mg tablet administered orally BID during the 12-week main study period and during the 40-week extension period, according to randomization.
15926163|NCT03449121|Behavioral|Slow breathing techniques|8 sessions of instruction in slow breathing exercises over 12 weeks of study
15926115|NCT03449498|Other|Qualitative functional therapy|Camps fot children with spastic CP are organised. Each camp consists of 10 days of 6 hours therapy per day. Six functional activities focusing on lower limbs and trunk are performed: walking, stair climbing, balance, transfers, trunk control, and Wii (combination of functional activities in sitting and/or standing). A group of clinical experts composes a set of exercises for each of these activities, however individual adaptations according to the needs and abilities of the child can be still be done. Quality of movement (alignment, weightshift, dissociation, coordination and stability) is hereby very important. The theme 'circus' is used to enhance the motivation of the children.
15926116|NCT03449498|Other|Functional therapy|Camps fot children with spastic CP are organised. Each camp consists of 10 days of 6 hours therapy per day. Goals are set with the parents and the children. During the camp children work on obtaining these goals in a exclusively functional way.
15926117|NCT03449485|Drug|Chlorprothixene|Patients are tested for their normal prescription chlorprothixene medication
15926118|NCT03449472|Drug|Quetiapine|Patients are tested for their normal prescription quetiapine medication
15926119|NCT03449459|Dietary Supplement|oral probiotics|"Culturelle™ DIGESTIVE HEALTH 30 CT(VCAP)(10 Billion Claim) which consists of 100% Lactobacillus rhamnosus GG, 1 tablet, q.d., for 3 months.
~Subjects will take conventional therapy at the same time."
15926120|NCT03449459|Drug|aerosol inhaled amikacin|"0.4g Amikacin sulfate injection + 5ml saline, aerosol inhalation, b.i.d., 5-7 days per month, for 3 months.
~In order to observe and cope with adverse events timely, subjects will be admitted to the ward during the course of medication.
~Subjects will take conventional therapy at the same time."
15926121|NCT03449459|Biological|combined vaccination|"Influenza Vaccine recommended by World Health Organization(WHO) in that year and imported 23-Valent Pneumococcal Polysaccharide Vaccine approved by China Food and Drug Administration(CFDA) are vaccinated at different body sites by professional nurses.
~The interval between two vaccinations is 3-5 days to avoid the overlap of adverse events.
~Subjects will take conventional therapy at the same time."
15926122|NCT03449446|Drug|SEL|18 mg tablet administered orally once daily without regard to food
15926123|NCT03449446|Drug|FIR|20 mg tablet administered orally once daily without regard to food
15926124|NCT03449446|Drug|CILO|30 mg tablet administered orally once daily without regard to food
15926125|NCT03449446|Drug|Placebo to match FIR|Tablet administered orally once daily without regard to food
15926126|NCT03449446|Drug|Placebo to match CILO|Tablet administered orally once daily without regard to food
15926127|NCT03449446|Drug|Placebo to match SEL|Tablet administered orally once daily without regard to food
15926128|NCT03449433|Drug|LY900014|Administered SC
15926129|NCT03449433|Drug|Insulin Lispro|Administered SC
15926130|NCT03449433|Drug|Insulin Aspart|Administered SC
15926131|NCT03449433|Drug|Insulin Aspart|Administered SC
15926132|NCT03449420|Diagnostic Test|thromboelastography|TEG5000® : Kaolin and Functional Fibrinogen tests on native blood sample
15926133|NCT03449394|Other|Metacognitive Training|4 sessions of Metacognitive Training using 4 treatment modules each targeting different cognitive biases
15926135|NCT03449342|Drug|turoctocog alfa|Patients will receive standard prophylaxis treatment and treatment of bleeding episodes, according to label. Trial product will be administered as intravenous injections (i.v.)
15926136|NCT03449329|Procedure|SIP|The intervention group will receive a SIP block
15926137|NCT03449316|Behavioral|Inhaler technique education|Teaching of inhalers use with placebo devices in real training
15926138|NCT03449303|Other|EOI|Topically-applied oil
15926139|NCT03449303|Other|Placebo|Topically-applied oil
15926140|NCT03449290|Other|Kinesio taping|Kinesio taping was applied on both sides of rectus abdominus, obliquus internus, obliquus externus and sacrospinalis muscles with muscle technique
15926141|NCT03449290|Other|Sham Kinesio taping|Kinesio taping was applied on both sides of rectus abdominus, obliquus internus, obliquus externus and sacrospinalis muscles without any technique
15926142|NCT03449277|Drug|Oral Tablet|oral labetalol tablets and oral nifedipine tablets
15926143|NCT03449264|Biological|biological collection|"Tissue samples (tumor tissue and healthy tissue) frozen and secured in paraffin collected during surgery.
~Blood samples taken at different times. During the blood samples taken for diagnosis and / or treatment, additional samples for research purposes will be carried out."
15926144|NCT03449251|Drug|Apelin|Apelin is an endogenous peptide that activate a single G-protein couple receptor. Apelin inhibits insulin secretion, decreases glucose levels and increases insulin sensitivity.
15926145|NCT03449251|Drug|Relaxin|Relaxin is RLN2 encoded endogenous peptide hormone, which binds to G protein coupled receptor RXFP1.
15926146|NCT03449251|Drug|Normal saline|Vehicle
15926147|NCT03449251|Diagnostic Test|Verapamil|NO independent challenge agent
15926148|NCT03449251|Diagnostic Test|LN Monomethyl arginine|Basal NO synthase inhibitor
15926149|NCT03449238|Drug|Pembrolizumab|pembrolizumab will be infused the day before SRS, at the standard dose of 200mg IV over 30 minutes and repeated every 3 weeks until disease progression or unacceptable toxicity.
15926150|NCT03449225|Other|Computer-Aided Genetic Education Module|Subjects will be provided with an electronic device to view Computer-Aided Genetic Education Module (CAGEM) software. This is an interactive software designed to provide subjects with tailored information regarding prenatal screening options for carrier status and aneuploidy.
15926151|NCT03449199|Drug|TMX-049|A certain dose of TMX-049 to be taken orally, once daily
15926152|NCT03449199|Drug|Placebo|Matching placebo to be taken orally, once daily
15926153|NCT03449186|Other|Saliva collection|
15926154|NCT03449186|Other|GCF collection|
15926155|NCT03449173|Drug|Sunitinib|small-molecule, multi-targeted receptor tyrosine kinase (RTK) inhibitor
15926156|NCT03449160|Device|UPRIGHT|A small externally wearable device that is placed on the back, which gently vibrates when correct posture is not maintained. The device is removable, and used for only portions of the day
15926157|NCT03449160|Other|physical therapy|routine physical therapy
15926158|NCT03449147|Drug|Placebo|Placebo tablet administered orally BID
15926159|NCT03449147|Drug|Gefapixant 15 mg BID|Gefapixant 15 mg tablet administered orally BID
15926160|NCT03449147|Drug|Gefapixant 45 mg BID|Gefapixant 45 mg tablet administered orally BID
15926165|NCT03449108|Biological|Autologous Tumor Infiltrating Lymphocytes LN-145|Given IV
15926166|NCT03449108|Biological|Autologous Tumor Infiltrating Lymphocytes LN-145-S1|Given IV
15926167|NCT03449108|Drug|Cyclophosphamide|Given IV
15926168|NCT03449108|Drug|Fludarabine|Given IV
15926169|NCT03449108|Biological|Ipilimumab|Given IV
15926170|NCT03449108|Biological|Nivolumab|Given IV
15926171|NCT03449108|Other|Quality-of-Life Assessment|Ancillary studies
15926172|NCT03449108|Other|Questionnaire Administration|Ancillary studies
15926173|NCT03449095|Drug|Alcohol|Alcohol Target BAC .08%
15926174|NCT03449082|Biological|High concentration of Allo-ASC|10 million cells of Allo-ASC 0.5cc
15926175|NCT03449082|Biological|Low concentration of Allo-ASC|1 million cells of Allo-ASC 0.5cc
15926176|NCT03449082|Drug|Fibrin glue|Fibrin glue 0.5cc
15926177|NCT03449082|Drug|Normal saline|Normal saline 0.5cc
15926178|NCT03449069|Drug|MSC-AFP|Patients will have a mesenchymal stromal cell coated anal fistula plug placed in their Crohn's perianal fistula tract.
15926179|NCT03449056|Drug|salbutamol|T2 - T1+1h30: High-nasal flow and salbutamol nebulization
15926180|NCT03449043|Other|Real care course|Evaluate the rate of adequacy between the request made by the general practitioner and the response to emergencies
15926181|NCT03449030|Drug|TAK-164|TAK-164 intravenous infusion.
15926182|NCT03449030|Drug|89Zr-TAK-164|89Zr-TAK-164 intravenous infusion
15926183|NCT03449017|Behavioral|E-cig use|Self-administration of e-cig (10 puffs in 5 minutes) prior to lab task, self-administration of e-cig (10 puffs in 5 minutes) prior to ad lib alcohol, and ad lib e-cig use throughout ad lib alcohol paradigm.
15926184|NCT03449004|Other|Validation of the OPSI questionnaire|A questionnaire to measure satisfaction with online information for patients with low back pain
15926185|NCT03448978|Biological|Descartes-08|autologous CD8+ T-cells transiently expressing an anti-BCMA chimeric antigen receptor
15926186|NCT03448978|Drug|Fludarabine|intravenous fludarabine
15926187|NCT03448978|Drug|Cyclophosphamide|intravenous cyclophosphamide
15926188|NCT03448965|Diagnostic Test|random blood sugar|do random blood sugar at 0 hour - 2 hours- 4 hours and after 6 hours
15926189|NCT03448939|Drug|S5G4T-1|once a day topical cream
15926190|NCT03448939|Drug|S5G4T-2|once a day topical cream
15926191|NCT03448926|Diagnostic Test|DCISionRT Test|The Prelude DCISionRT Test was developed by Prelude Corporation and is performed at its CLIA laboratory facility. The biomarkers used to evaluate the biologic signature of DCIS tissue are based on over a decade of research including the University of California, San Francisco, Yale University as well as Prelude Corporation. The test is prognostic for 10-year recurrence risk and predicts RT treatment benefit for invasive breast cancer. The laboratory is regulated under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) as qualified to perform high-complexity clinical testing and is accredited by the College of American Pathologists (CAP).
15926192|NCT03448913|Procedure|PECS block|It consists in injection of 20-30 ml of local anesthetic between pectoral minor, pectoral major, and serratus muscles.
15926193|NCT03448900|Behavioral|Multicomponent intervention|Motivational interview (50 minutes), on-line self-help material, support e-mail, group therapy, and second motivational interview (20 minutes)
15926194|NCT03448900|Behavioral|Brief advice|Brief advice (5-10minutes) and a self-help pamphlet
15926195|NCT03448887|Device|Theranova|Extended HD with theranova
15926196|NCT03448887|Device|Online hemodiafiltration|Online hemodiafiltration
15926197|NCT03448874|Device|Seal-G MIST System|Seal-G MIST is an adjunct device that will be applied adjunctively to cover standard closure techniques.
15926198|NCT03448861|Device|Polso Wearebale watch|The objective of the Polso™ feasibility study is to demonstrate the suitability of Polso™ as a data acquisition and processing platform by comparison with the conventional British version of EWS (UK-NEWS) on aggregate and on each individual parameter score. Although in a full NEWS system, the frequency of testing is determined by the score itself, this aspect will not be evaluated, in the event that a divergence of scores would complicate clinical evaluation and correspondence of readings. In addition, good clinical practice calls for patient care to be fully motivated by the NEWS currently in use, as opposed to the experimental Polso™. Therefore, this compromise will be made, which will still permits system evaluation.
15926199|NCT03448848|Drug|BCAA preparation Intravenous infusion|BCAA IVi in a dose 0.5-1 gm/Kg/day for 2-5 days post liver surgery versus sterile normal saline in a volume equal to the study drug
15926200|NCT03448848|Drug|sterile normal saline|sterile normal saline in a volume equal to the study drug
15926201|NCT03448835|Drug|Atezolizumab|atezolizumab 1200 mg 5 cycles
15926202|NCT03448835|Drug|Capecitabine|capecitabine 850 mg /m2 4 cycles
15926203|NCT03448835|Drug|Oxaliplatin|oxaliplatin 100 mg/m2 4 cycles
15926204|NCT03448835|Drug|Docetaxel|docetaxel 50 mg/m2 4 cycles
15926205|NCT03448822|Procedure|sentinel node procedure|a robot-assisted laparoscopic sentinel node procedure to detect occult lymph node metastasis
15926206|NCT03448809|Behavioral|Mind My Mind|An individual, modular and flexible cognitive and behavioural therapy
15926207|NCT03448809|Behavioral|TAU (Treatment as Usual)|The children were offered anonymous counselling, supportive talk therapy, pedagogical advice, network meetings, and/or individual support in the school setting. A few were offered group-based CBT-programs for selected problems, but the access to manualized treatment was generally very restricted.
15926208|NCT03448796|Procedure|HTO|Group that receives high tibial osteotomy combined with supervised physiotherapy as treatment.
15926209|NCT03448796|Other|Supervised physiotherapeutic program|Group that receives only supervised physiotherapy as treatment.
15926210|NCT03448783|Drug|Apixaban|Patients are tested for their normal prescription apixaban medication
15926211|NCT03448770|Drug|PEG- 17 gm sachet|PEG- 17 gm sachet 3-4 times per day
15926212|NCT03448770|Drug|Lactulose : 20-30gm|Lactulose : 20-30gm
15926251|NCT03448393|Biological|CD19/CD22 CAR T-Cells|CD19/CD22 cells will be infused on Day 0 after induction chemotherapy regimen.
15926252|NCT03448393|Drug|Fludarabine|Fludarabine is administered as an IV infusion in an appropriate solution over 30 minutes. To prevent undue toxicity the dose will be based on BSA (25 mg/m2/dose)
15926334|NCT03447795|Procedure|Alveolar ridge preservation|grafting procedure using autogenous tooth.
15926213|NCT03448757|Other|measuring hemodynamic parameters heart beat to heart beat during single-frequency exposure|"This study aims to create a method for non-invasive diagnosis of biofeedback effect exposure to LEEF modulated to specific frequencies in individuals exposed to hepatocellular carcinoma -specific frequencies in increasing sequential manner, frequency to frequency in patients with advanced hepatocellular carcinoma and healthy individuals.
~Patients with advanced hepatocellular carcinoma will be exposed to specific LEEF-modulated frequencies (3 to 10 Hz difference) to identify the optimal frequency associated with greater response to the biofeedback effect in patients with advanced hepatocellular carcinoma."
15926214|NCT03448744|Drug|Thymosin Alpha1|Thymosin Alpha1 (1.6 mg subcutaneously injection twice a week) plus ETV (0.5 mg orally, daily) for 24 weeks, and followed by continuous ETV for at least 48 weeks
15926215|NCT03448744|Drug|Entecavir|ETV (0.5 mg orally, daily) for 72 weeks
15926216|NCT03448731|Drug|Doxycycline 50Mg Tablet|Doxycycline administered p.o once daily at a 50 mg dose for 6 weeks beginning on Day -1
15926217|NCT03448718|Drug|Olaparib|1 cycle = 28 days. Subject's with calculated creatinine clearance (CrCl) of ≥ 40 mL/min will start at a dose of olaparib tablets of 300 mg twice a day. Subjects with a CrCl of > 30 to < 40 mL/min will start at a dose of olaparib tablets 200 mg twice a day.
15926218|NCT03448705|Biological|4Fluart ID suspension for injection study drug 1 µg/0.1 ml, influenza vaccine (whole virion, inactivated, adjuvanted)|Route of administration: intradermal, Dosage: 1 μg HA/strain / 0.1 ml, Package: 0.5 ml in one ampoule from which 0.1 ml is equal to a single dose, Dosage regimen: 1 x 0.1 ml, Treatment duration: single dose.
15926219|NCT03448705|Biological|4Fluart ID suspension for injection study drug 2 µg/0.1 ml, influenza vaccine (whole virion, inactivated, adjuvanted)|Route of administration: intradermal, Dosage: 2 μg HA/strain / 0.1 ml, Package: 0.5 ml in one ampoule from which 0.1 ml is equal to a single dose, Dosage regimen: 1 x 0.1 ml, Treatment duration: single dose.
15926220|NCT03448705|Biological|3Fluart suspension for injection, influenza vaccine (whole virion, inactivated, adjuvanted)|Route of administration: intramuscular, Dosage: 6 μg HA/strain / 0.5 ml, Package: 0.5 ml in one ampoule from which a total of 0.5 ml is equal to a single dose, Dosage regimen: 1 x 0.5 ml, Treatment duration: single dose.
15926221|NCT03448692|Drug|PF-06730512|Subjects in cohort 1 will receive Dose 1 Intravenous infusion (IV). Subjects in cohort 2 will receive Dose 2 IV.
15926222|NCT03448666|Combination Product|Pembrolizumab|Electrochemotherapy will be performed with the CLINIPORATOR™ after the first treatment of Pembrolizumab
15926223|NCT03448653|Other|Colonoscopy with NBI|Colonoscopy with NBI
15926224|NCT03448640|Drug|Drug used in the examination of premature infants.|to investigate side effects of eye drops used
15926225|NCT03448601|Other|Culturally tailored brochure intervention group|Culturally-tailored Alzheimer's Disease and precision medicine educational brochure.
15926226|NCT03448601|Other|Culturally tailored video intervention group|Culturally-tailored Alzheimer's Disease and precision medicine educational video.
15926227|NCT03448588|Diagnostic Test|detection of serum selenium|For this case-control study, no intervention will be administered to participants, only serum sample will be collected for selenium assessment
15926228|NCT03448575|Other|Control - Provider Medication Alert Only|Simple text medication alert referencing Choosing Wisely guidelines.
15926229|NCT03448575|Other|Intervention - Alert + CAP Review AND Enhanced BH Access|Interactive medication alert referencing SUAY Clinical Guidelines and offering options to keep/remove orders for the antipsychotic, virtual CAP consult, BH navigation for the patient, and access to bridging therapy for the patient.
15926230|NCT03448562|Procedure|CPVI|ablate around the pulmonary vein orifice
15926231|NCT03448562|Procedure|STABLE-SR|homogenization of the low voltage zones and elimination of the complex electrograms from the transitional zones during sinus rhythm
15926232|NCT03448549|Drug|Oxaliplatin|adjuvant chemotherapy
15926233|NCT03448549|Drug|Tegafur，gimeracil and oteracil potassium|adjuvant chemotherapy
15926234|NCT03448549|Drug|Xeloda|adjuvant chemotherapy
15926235|NCT03448536|Drug|Naproxen Sodium, (Aleve, BAY117031)|220 mg *2 tablets, orally, single dose
15926236|NCT03448536|Drug|Acetaminophen (Tylenol Extra Strength)|500 mg *2 caplets, orally, single dose
15926237|NCT03448523|Behavioral|Right To Play's Positive Child and Youth Development program|"Right To Play's Red Ball Child Play manual provided for 60 hours per annum for two years
~Training of junior leaders
~Related play-based activities such as sports days
~Quarterly awareness sessions with community groups and parents
~Summer camps for children
~training of teachers on Right To Play's foundational resources, positive disciplining, and gender and child protection"
15926238|NCT03448510|Device|Irreversible electroporation|The subject will receive Irreversible electroporation procedure which is a novel ablation modality using electric pulses to create nanoscale defects in the cell membrane.
15926239|NCT03448510|Drug|Standard Medication|The subject will be prescribed with α-blocker or/and 5α-reductase inhibitors.
15926240|NCT03448497|Other|Non-interventional|Non-interventional
15926241|NCT03448484|Dietary Supplement|Intervention (integrated package)|"Provided to all intervention households:
~Soap (for daily hand washing)
~Chlorine solution (for daily drinking water treatment)
~8 birds of chicken (child consumes 1 egg/day)
~Vegetable seeds (red onion, indigenous managu and sukuma)
~Monthly trainings to all farmers on nutrition and WASH
~Micronutrient powder (MixMe, 1g sachet every third day)
~Oral rehydration solution (ORS) + zinc (to be used to treat acute diarrhoea: 20 mg zinc tablets; ORS sachets (10.3 g/sachet))
~All families in the intervention group will receive the same agriculture-focused package (see section 'control intervention' below) as those in the control group."
15926242|NCT03448484|Other|Control|"Active control: The families living in the control clusters will receive the agriculture-focused package that is already in place in all participating clusters through the 1AF programme. The control intervention is the same for study 1 and study 2. This agriculture-focused package consists of:
~Agricultural training (every 2 weeks on average) for all
~Free to enrol for the following products on credit:
~Compost boosters
~Cook stoves
~Seeds (onions, maize, indigenous greens, beans)
~Maize storage bags
~Drying tarps
~Trees
~Solar lights
~Fertilizer
~Actellic dust (insecticide)
~Re-usable sanitary pads"
15926243|NCT03448458|Procedure|CT (Computed Tomography)|Undergo PET/CT
15926244|NCT03448458|Drug|Gallium Ga 68-DOTATATE|Given IV
15926245|NCT03448458|Procedure|Positron Emission Tomography|Undergo PET/CT
15926246|NCT03448445|Other|Usual care setting|usual care settings without any intervention
15926253|NCT03448393|Drug|Cyclophosphamide|Cyclophosphamide will be diluted in an appropriate solution and infused over one hour. The dose will be based on the patient s body weight, at 900 mg/m2/dose after fludarabine infusion on Day -2.
15926254|NCT03448380|Device|FreeStyle Libre Flash Glucose Monitoring System|Subjects will utilize capillary SMBG for managing diabetes for 6 months (control phase) followed by diabetes management using FreeStyle Libre for 6 months (intervention phase).
15926255|NCT03448367|Device|FreeStyle Libre Flash Glucose Monitoring System|Subjects will utilize capillary SMBG for managing diabetes for 6 months (control phase) followed by diabetes management using FreeStyle Libre for 6 months (intervention phase).
15926256|NCT03448354|Procedure|HIPEC|HIPEC(paclitaxel 175mg/m2, 90min; open or closed technique) after IDS . IDS is recommended within 4 weeks after the 3rd NAC cycle. HIPEC procedure is allowed only in case of residual disease less than 5mm.
15926257|NCT03448328|Dietary Supplement|NUTRALYS pea protein supplement|0.3 grams of protein per kilogram of body weight before and after eccentric exercise, and each of 4 mornings of recovery
15926258|NCT03448328|Dietary Supplement|Whey Protein|0.3 grams of protein per kilogram of body weight before and after eccentric exercise, and each of 4 mornings of recovery
15926259|NCT03448328|Dietary Supplement|Apple juice|1.2 calories per kilogram body weight before and after eccentric exercise, and each of 4 mornings of recovery
15926260|NCT03448315|Device|tDCS|motor cortex stimulation (2 mA, 20 min for 4 sessions)
15926261|NCT03448302|Radiation|Computed tomography perfusion|Pre-contrast images will be obtained to identify the colorectal tumor location. Then Fifty milliliters of iopromide (Ultravist ) will be injected intra-venously at rate of 5 milliliter per second via an automatic pump injector for computed tomography perfusion scans. Computed tomography perfusion scans will be performed at the mid-portion of the tumor for 60seconds beginning 5 seconds after contrast injection. Then arterial input will be defined by using the mouse to place a circular region of interest and the tumor region of interest will be placed on the most enhanced area of the tumor. Tumor blood flow, blood volume, mean transient time & permeability surface measurements will be obtained.
15926262|NCT03448289|Behavioral|RLPT|The Reproductive Life Plan Tool (RLPT) will be self-administered. Pediatricians will use the RLPT to assess women's need for well-woman primary care.
15926263|NCT03448276|Other|Training in the vibrating platform|20-minute workout will be held, which will include: heating (5 minutes and stretching for the muscles quadriceps and sural triceps), 10 and 5 min of cooling.
15926264|NCT03448276|Other|Walk|Will be held 30 minutes of training, which will include the heating (5 minutes of stretching for the muscles quadriceps and sural triceps), 10 and 5 min of cooling.
15926265|NCT03448263|Procedure|Balanced Force technique|Flex-R files sizes 15-45 taper .02 were used according to the technique on each tooth
15926266|NCT03448263|Procedure|WaveOne technique|"WaveOne instrument was used to prepare narrow, straight and curved canals, and file (40.08) was used for large canals.
~Three in-and-out motions were used with lengths not beyond 3 mm in the three thirds of the canal until reaching the estimated WL."
15926267|NCT03448263|Procedure|Reciproc technique|Reciproc files were used in wide canals. Three in-and-out motions were used with lengths not beyond 3 mm in the three thirds of the canal until reaching the estimated WL.
15926268|NCT03448250|Behavioral|Optimune|Optimune is a web-based psychological intervention developed for women with breast cancer.
15926269|NCT03448250|Other|Care-As-Usual|Participants are free to continue to engage with any treatment they require (i.e., CAU).
15926270|NCT03448237|Other|Speech Therapy|Speech therapy adapted to the child, at least 25 sessions over 9 months.
15926271|NCT03448237|Other|Proprioceptive treatment|"Proprioceptive treatment adapted to the child.
~This treatment aims to stabilize a central reference instability revealed to Maddox Postural by the use of neurosensory decoys::
~Proprioceptive stimulation of oculomotor muscles (active prisms).
~Oral somatosensory stimulation (ALPH).
~Proprioceptive antigravity stimulation (proprioceptive sole).
~Proprioceptive reprogramming exercise.
~Following the teaching of the University Diploma: Perception-Action, Learning Disorders (University of Bourgogne, France)"
15926272|NCT03448224|Other|Questionnaire Administration|Questionnaire
15926273|NCT03448224|Other|Internet-Based Intervention|Intervention
15926274|NCT03448211|Drug|Para-toluenesulfonamide Injection (PTS)|Intratumoral injection
15926275|NCT03448198|Procedure|Total knee replacement|Primary knee gonarthrosis treated with navigated total knee replacement and computer-assisted patellar replacement.
15926276|NCT03448185|Behavioral|High intensity exercise|Subjects will be randomized to the exercise groups will undergo 1 year aerobic exercise training comprised of high intensity exercise sessions 2-3 days per week. Sessions will be supervised remotely via heart rate monitors.
15926277|NCT03448185|Dietary Supplement|Omega-3 fish oil|Subjects randomized to omega-3 fatty acids will take 2 grams total of omega-3 per day for 1 year.
15926278|NCT03448185|Behavioral|Yoga|Subjects randomized to yoga will undergo yoga training as a control to those randomized to high intensity aerobic exercise.
15926279|NCT03448185|Dietary Supplement|olive oil capsules|Subjects randomized to receive olive oil placebo will take 1 gram total of olive oil capsule per day.
15926280|NCT03448172|Drug|[14C]PF-05221304|a single oral dose of [14C]PF-05221304 (50 mg/100 µCi liquid formulation)
15926281|NCT03448159|Drug|Fluoxetine Hydrochloride|Half of the participants will take fluoxetine for a period of 15-17 weeks (depending on ramp-up period).
15926282|NCT03448159|Other|Placebo|Half of the participants will take the a placebo for a period of 15-17 weeks (depending on ramp-up period).
15926283|NCT03448159|Behavioral|Exercise Program|All participants will take part in a 12-week exercise program. The program will run 3 times/week, 1 hour/class.
15926284|NCT03448146|Drug|Para-Toluenesulfonamide|
15926285|NCT03448133|Device|Magstim rTMS|The device is made in London,UK
15926286|NCT03448120|Procedure|Acupuncture|Six needled will be inserted in six already defined acupoints along the non-dominant upper limb for a period of 30 minutes.
15926287|NCT03448120|Procedure|Dry needling|Six needles will be inserted in six predefined points along the volunteers non-dominant biceps brachialis for 30 minutes.
15926288|NCT03448107|Device|Silver Diamine Fluoride|Silver diamine fluoride (SDF)
15926289|NCT03448107|Device|Fluoride Varnishes|Fluoride varnish (FV)
15926290|NCT03448107|Device|Glass Ionomer|Glass Ionomer Sealants (GC Fuji IX)
15926291|NCT03448094|Dietary Supplement|Resveratrol|Participants will consume one of the treatment types daily for a period of three months.
15926292|NCT03448094|Dietary Supplement|Placebo|Participants will consume one of the treatment types daily for a period of three months.
15926293|NCT03448081|Drug|SNA-120|SNA-120 (0.5%) active ointment
15926294|NCT03448081|Drug|Placebo|Vehicle Ointment
15926295|NCT03448081|Drug|Calcipotriene|Calcipotriene ointment (0.005%)
15926296|NCT03448068|Drug|Ketamine|"Ketamine 0.3 mg/kg (IBW) bolus with induction. Ketamine infusion 0.2mg/kg/hr. (IBW) initiated after induction and terminated after 24 hours.
~Ketamine infusion not titrated."
15926297|NCT03448068|Drug|Standard therapy|"Pre-op dexamethasone 4mg IV and midazolam 1-2mg IV Anesthesia Induction - Propofol 2-3mg/kg IV, Fentanyl 1mcg/kg IV, neuromuscular block w/succinylcholine and/or rocuronium, orotracheal intubation Anesthesia maintenance - Sevoflurane/rocuronium, fentanyl 0.5-1mcg/kg Anesthesia emergence - Acetaminophen 1g, ketorolac 30 mg IV, ondansetron 4mg IV, sugammadex 2mg/kg or 4 mg/kg dose depending on twitch Post-op anesthesia - Hydromorphone patient-controlled analgesia (PCA) 0.2 mg/8 min, acetaminophen 1 g IV Q8 around the clock (ATC) x 3 addl. doses, ketorolac 15 mg IV Q6 ATC x 3 addl. doses.
~Other standard surgical post-op care"
15926298|NCT03448055|Dietary Supplement|Immunocal|cysteine-rich whey protein isolate
15926299|NCT03448042|Drug|BTRC4017A|BTRC4017A will be administered via IV infusion from until disease progression, intolerable toxicity, or any other discontinuation criteria are met.
15926300|NCT03448016|Radiation|[C-11]|Radiolabel
15926301|NCT03448016|Drug|NOP-1A|Tracer
15926302|NCT03448003|Other|Cancer Prevention|Attend IO prevention program
15926303|NCT03448003|Other|Questionnaire Administration|Ancillary studies
15926304|NCT03447990|Drug|MYK-491|Single Ascending Dose and Multiple Ascending Dose of MYK-491
15926305|NCT03447990|Drug|Placebo|Single Ascending Dose and Multiple Ascending Dose of placebo
15926306|NCT03447977|Other|cervical|cervical spine manual therapy
15926307|NCT03447977|Other|thoracic|thoracic spine manual therapy
15926308|NCT03447977|Other|exercises|exercises for pain
15926309|NCT03447964|Other|dosing of sphingolipids|- Measuring the concentration of many species of sphingomyelins, ceramides, dihydroceramides and sphingosine
15926310|NCT03447951|Drug|Para-Toluenesulfonamide|A total dose of PTS100 in this study, the expected accumulated dose in the treatment duration, depends on the patient's tumour size. For each patient, up to 4 tumors, each not exceeding 8.8 cm in diameter, are selected for treatment by the joint decision of the investigator and the radiologist. The total dose is defined as the accumulated dose in treatment duration. The total dose is randomly assigned as either 20% or 30% of TTV for each patient and maximum TTV should be less than 366 cm3.
15926311|NCT03447938|Procedure|MICS CABG|Coronary artery bypass grafting performed through small incisions between the ribs.
15926312|NCT03447938|Procedure|Conventional CABG|Coronary artery bypass grafting performed through an incision through the sternum or breastbone.
15926313|NCT03447925|Drug|Medicinal Plant|Medicinal Plant Extract with vaseline cream
15926314|NCT03447925|Drug|Salicylate|Salicylate 10% with vaseline cream
15926315|NCT03447925|Drug|Vaseline|Vaseline cream
15926316|NCT03447912|Behavioral|Intervention Condition|The intervention approach will be informed by the Community Coalition Action Theory (CCAT) developed by Butterfoss and Kegler. CCAT posits that coalitions form due to a threat, opportunity, or mandate. Public health center staff will form a coalition by recruiting partner organizations from civil society and other government sectors (e.g., health care, education), conduct situational assessment, and develop and implement action plans to promote the adoption and enforcement of smoke-free policies in worksites and restaurants.
15926317|NCT03447899|Behavioral|Attachment and Biobehavioral Catch-up (ABC)|Attachment and Biobehavioral Catch-up (ABC) is an in-home, 10-session, manualized parent-training program for children ages 6 months through 2 years who have experienced early adversity. ABC utilizes parent-child interactions to enhance positive interactions with the child through live coaching with particular focus on nurturing behaviors, following the child's lead, non-frightening behaviors. These behaviors include appropriate soothing and comforting when a child is distressed, responding to or imitating a child in a contingent way, and displaying warmth.
15926318|NCT03447886|Other|Phone interview|Collecting clinical and socio-demographic information.
15926319|NCT03447873|Drug|Continue with triple therapy|To continue with triple therapy
15926320|NCT03447873|Drug|Switch to DTG + 3TC|Switch to dolutegravir + lamivudine once daily
15926321|NCT03447873|Drug|Switch to DRV/cobicistat + 3TC|Switch to darunavir/cobicistat + lamivudine once daily
15926322|NCT03447860|Behavioral|PAACC|Mindfulness based caregiver intervention that includes education , problem solving, skill building, stress management and mindfulness to help enhance compassion and acceptance of self and others
15926323|NCT03447860|Behavioral|REACH-VA|A cognitive-behavior based multi-component caregiver intervention to reduce caregiver stress
15926324|NCT03447847|Other|Water|1 liter of water in meals; 1 liter out of meals
15926325|NCT03447834|Other|Selective intracoronary hypothermia + PPCI|Selective intracoronary hypothermia is a new technique, recently tested for safety and feasibility in the SINTAMI trial. The procedure starts by advancing a guidewire beyond the occlusion in the culprit artery, followed by an OTWB that is inflated at the location of the occlusion, at a low pressure (4 atm), to prevent reperfusion. After that, a pressure/temperature wire will be advanced along the inflated OTWB and is placed in the distal coronary artery. Then the guidewire is removed and the lumen is used for infusion of saline. During the 'occlusion phase', saline at room temperature is infused for 10 minutes with distal coronary temperature 6-8°C below body temperature. After that, the balloon of the OTWB is deflated. Simultaneously, infusion is started with saline of 4°C, the so called 'reperfusion phase'. This is continued for 10 more minutes. After that, the OTWB can be retracted and the procedure can continue not different from routine PPCI.
15926326|NCT03447834|Other|Standard PPCI|PPCI per routine
15926327|NCT03447821|Drug|400 mg Rifamycin SV dosage|
15926328|NCT03447821|Drug|800 mg Rifamycin SV dosage|
15926329|NCT03447821|Drug|1200 mg Rifamycin SV dosage|
15926330|NCT03447808|Biological|Daratumumab|Given IV
15926331|NCT03447808|Drug|Ibrutinib|Given PO
15926332|NCT03447808|Other|Laboratory Biomarker Analysis|Correlative studies
15926333|NCT03447808|Other|Pharmacological Study|Correlative studies
15926335|NCT03447782|Drug|Naltrexone HCl (Bulk) Powder|For the NDPH Persistent group, patient will take naltrexone, 4.5 mg, po 1 time/day for three months-Naltrexone will be compounded from Naltrexone HCL powder
15926338|NCT03447756|Drug|ABX-1431|Capsules of either 2mg, 10mg, or 50mg
15926339|NCT03447756|Drug|Placebo oral capsule|placebo to match
15926340|NCT03447743|Drug|XR-NTX community location|XR-NTX will be administered at the local health care clinic
15926341|NCT03447730|Drug|SYNB1020|SYNB1020 was supplied at a concentration of approximately 1 × 10^11 CFU/mL in a buffered solution in 5 mL cryovials with a nominal 5 mL fill volume, administered with 100 mL of masking buffer solution.
15926342|NCT03447730|Other|Placebo|Subjects received placebo orally in a chilled buffered solution (100 mL).
15926343|NCT03447717|Device|ActiGait|implanted device for peroneal nerve stimulation
15926344|NCT03447704|Drug|BCD-085|120 mg of BCD-085 subcutaneously at week 0,1 and 2 every other week
15926345|NCT03447704|Other|placebo|2 ml of placebo subcutaneously at week 0,1 2 and every other week, starting from week 16 - 120 mg of BCD-085 subcutaneously at week 16,17 and 18 every other week
15926346|NCT03447691|Drug|Des (volatile anesthetic-desflurane)|Inducing unconciouness with 1.5 to 2 mg/kg of propofol, Intubation is performed 3 minutes after administration of remifentanil 1-2 mcg / kg and rocuronium 0.6 mg / kg. Desflurane concentration is maintained 3-7% (0.7-1.1 MAC) and remifentanil continuous infusion (0.02-0.2 mcg / kg / min).
15926347|NCT03447691|Drug|TIVA (Total intravenous anesthesia with propofol and remifentanil)|TIVA group is administered with intravenous anesthetic using commercial target controlled infusion (TCI) pump. Anesthesia is induced and maintained with 2-6 mcg / ml propofol and 2-6 ng / ml remifentanil, which are converted to the effect site concentration. After administrating rocuronium 0.6mg/kg, intubation is performed.
15926348|NCT03447678|Drug|Pembrolizumab|humanized antibody used in cancer immunotherapy
15926349|NCT03447665|Behavioral|Bedtime routine|Tailored bedtime routine
15926350|NCT03447665|Behavioral|Sleep schedule|Tailored sleep schedule, including morning rise time, cut-off for last nap of the day, and bedtime.
15926351|NCT03447665|Behavioral|Intervention (bedtime)|Parents implement behavioral sleep intervention at bedtime.
15926352|NCT03447665|Behavioral|Intervention (after night wakings)|Parents implement behavioral sleep intervention following each night waking.
15926353|NCT03447652|Other|Resistance Band Ankle Rehabilitation|Resistance Band - uses a tension band to provide resistance during ankle motion
15926354|NCT03447652|Other|Biomechanical Ankle Platform System Rehabilitation|Biomechanical Ankle Platform System Board Group - uses different levels of half spheres to increase the amount of motion allowed at the ankle.
15926355|NCT03447652|Other|Combination Rehabilitation|Combination Group - includes both the resistance band and Biomechanical Ankle Platform System programs.
15926356|NCT03447639|Drug|Povidone-iodine irrigation|Single dose, 60 cc of 2% povidone-iodine indwelling for 10 minutes prior to catheter removal using aseptic technique
15926357|NCT03447626|Device|MAKO Robotic UKA|Prospective UKA patient receiving unilateral knee arthroplasty using the MAKO robotic machine
15926358|NCT03447613|Procedure|surgery|All participants were scheduled to have elective total hip or knee replacement surgery, ureteroscopic lithotripsy and transurethral resection of the prostate under spinal anesthesia at the Shanghai 10th People's Hospital. After 5 years, the investigaors will follow up the participants including cognitive functions, PET-CT, thickness of Retinal Nerve Fiber Layer.
15926359|NCT03447600|Behavioral|Alternate Day Fasting|25% daily energy requirements every other day until study completion at >/=5% weight loss which is an average of 12 weeks.
15926360|NCT03447600|Behavioral|Continuous dietary restriction|25% daily energy requirements every other day until study completion at >/=5% weight loss which is an average of 12 weeks.
15926361|NCT03447587|Other|Electroacupuncture|Each subject will be treated with predefined acupoints including bilateral Ear-Shenmen, Touwei (ST8), Sishencong (EX-HN1), and unilateral Yintang (EXHN3) and Baihui (GV20) on the head (total 8 needles). Subject's current symptoms will be ascertained using a Traditional Chinese Medicine symptom checklist and eight additional acupoints will therefore be selected and needled based on their clinical judgements. The acupuncture treatment will consistent of two sessions per week (30 minutes) for 4 consecutive weeks.
15926362|NCT03447587|Other|Sham acupuncture|Subjects will be treated at 1 cm posteriorly and laterally adjacent to the same acupoints as the traditional acupuncture group using validated non-invasive sham needles. Subjects will also be assessed with Traditional Chinese Medicine checklist. The acupuncturist, setting, treatment frequency, and duration of the treatment course will be the same as in the traditional acupuncture group.
15926363|NCT03447574|Other|ethanol dilution|Ethanol has been validated against deuterium oxide, the invasive gold standard for determining totally body water
15926364|NCT03447561|Behavioral|Anticipatory + consummatory food reward|Exposure to a combination of anticipatory (viewing high-calorie food images) and consummatory food reward (drinking sips of chocolate milkshake).
15926365|NCT03447561|Behavioral|Consummatory food reward|Exposure to consummatory food reward (drinking sips of chocolate milkshake).
15926366|NCT03447548|Behavioral|Neurofeedback processing speed training|Processing speed training on tablets that incorporates changes in pupil size to titrate the learning algorithm
15926367|NCT03447548|Behavioral|Active control|Commercially available games on tablet
15926368|NCT03447535|Other|Semi-directive interview (Kiddy Sads)|semi-directive interview (Kiddy Sads) conducted as part of the care
15926369|NCT03447535|Other|SDQ questionnaires (strenghs and difficulties questionnaire)|SDQ questionnaires (strenghs and difficulties questionnaire) conducted as part of the care
15926370|NCT03447509|Device|iTMS|Small magnetic pulse will be given to the brain in a non invasive manner.
15926371|NCT03447509|Other|Motor Task|Participants will be asked to perform specific motor tasks or movements with their fingers, hands, and arms.
15926372|NCT03447509|Device|Sham iTMS|Sham or fake stimulation will be given to the brain in a non invasive manner.
15926373|NCT03447509|Other|Training|The participant will be instructed to do repetitive motor movements with their arm or hand.
15926374|NCT03447496|Procedure|Closed reduction|The children were treated with closed reduction.
15926375|NCT03447496|Procedure|Open reduction|The children were treated with Open reduction.
15926376|NCT03447483|Other|Patients starting a treatment by ICI|"Completion of the Quality of Life Questionnaire Core 30 (QLQ-C30) before treatment administration and during the 12 months of treatment period, at the following time points:
~every 6 weeks for treatment regimen administered every 2 or 3 weeks
~at Weeks 6, 12, 20, 24 for treatment regimen administered every 4 weeks"
15926377|NCT03447470|Drug|RXC004|RXC004 is taken orally, inhibits porcupine (PORCN) and interacts with the wnt signalling pathway
15926378|NCT03447470|Drug|Nivolumab|Nivolumab is a fully human monoclonal immunoglobulin G4 antibody to PD-1
15926379|NCT03447457|Device|High-flow oxygen|HFNC is continuously applied via large-bore nasal prongs with a gas flow rate of 50 L/min and a FiO2 adjusted to maintain a pulse oxymetry at least 92%
15926380|NCT03447457|Device|Standard oxygen|nasal cannula, face mask or non-rebreathing reservoir mask
15926381|NCT03447444|Other|music and physical activity|This feasibility study focus on promoting a combination of music therapy and physical activity with the primary goal to describe the influence on restlessness, irritability, and aggression in persons with severe stage of dementia with a mixture of symptoms including frontal lobe problems in institutional care. A secondary goal is to investigate the treatment fidelity.
15926382|NCT03447418|Procedure|Multiple breath nitrogen washout|Lung Clearance Index (LCI) will be performed in healthy volunteers with a multiple breath nitrogen washout device.
15926383|NCT03447405|Device|Dino Egg|DINO EGG speakers, a NICU-safe and developmentally appropriate music player that delivers parent's voice to the bedside of NICU infants. The device passed NCH NICU-safe products committee and has been used in the clinical setting delivering clinical music therapy services (available at bedside to play parents' voice).
15926384|NCT03447392|Behavioral|Discharge Education of Chinese Medicine|Discharge Education of Integrated Traditional and Western Medicine
15926385|NCT03447379|Drug|1. P2Y12 inhibitor monotherapy after 3 months of DAPT|"P2Y12 inhibitor(Clopidogrel 75mg/day or Ticagrelor 180mg/day) for 9months after 3 months of DAPT(Aspirin 100mg + Clopidogrel 75mg/day or Aspirin 100mg + Ticagrelor 180mg/day)
~DAPT(Aspirin 100mg + Clopidogrel 75mg/day or Aspirin 100mg + Ticagrelor 180mg/day) for a year"
15926386|NCT03447366|Diagnostic Test|mitral doppler|Mitral doppler before and after vascular filling
15926387|NCT03447353|Drug|Xanax 1Mg Tablet|Single dose on two of four visits, one in conjunction with 1 tab of 10mg/325mg Norco
15926388|NCT03447353|Drug|Norco 10Mg-325Mg Tablet|Single dose on two of the four study visits, one in conjunction with 1mg alprazolam
15926389|NCT03447353|Drug|Placebo Oral Tablet|Single dose on two of the four study visits, double dose on one of the four study visits
15926390|NCT03447340|Behavioral|Canteen and Behavior intervention|"canteen intervention: (a) form and train a canteen improvement team; (b) train canteen staff on healthy cooking; (c) add healthy food and remove unhealthy food; (d) information and communication of canteen changes to employees; (e) monitoring of the interventions.
~Behavioral : 16 core classes and 8 maintenance classes"
15926391|NCT03447340|Other|Canteen Only|canteen intervention: (a) form and train a canteen improvement team; (b) train canteen staff on healthy cooking; (c) add healthy food and remove unhealthy food; (d) information and communication of canteen changes to employees; (e) monitoring of the interventions.
15926392|NCT03447327|Procedure|single burr hole|patients with CSDH operated by single burr hole craniostomy under local anaesthesia
15926393|NCT03447314|Drug|GSK1795091|GSK1795091 will be available as solution for injection
15926394|NCT03447314|Drug|GSK3174998|GSK3174998 will be available as lyophilized powder to be reconstituted for infusion.
15926395|NCT03447314|Drug|GSK3359609|GSK3359609 will be available as solution for infusion.
15926396|NCT03447314|Drug|Pembrolizumab|Pembrolizumab will be available as solution for infusion or lyophilized powder for reconstitution.
15926397|NCT03447301|Dietary Supplement|Extra virgin olive oil (30mL daily)|Intervention arm will take 30 mL of Extra virgin olive oil daily.
15926398|NCT03447275|Other|Type 2 diabetes|Test if patients with diabetes have different blood concentrations of vitamin biomarkers compared with control subjects and if vitamin levels in the patients will differ according to renal damage.
15926399|NCT03447262|Drug|VX-659|Fixed-dose combination (FDC) tablets (VX-659/TEZ/IVA)
15926400|NCT03447262|Drug|TEZ|FDC tablets (VX-659/TEZ/IVA)
15926401|NCT03447262|Drug|IVA|FDC tablets (VX-659/TEZ/IVA)
15926402|NCT03447262|Drug|IVA|IVA tablet
15926403|NCT03447249|Drug|VX-659/TEZ/IVA|Participants received VX-659/TEZ/IVA orally once daily in the morning.
15926404|NCT03447249|Drug|IVA|Participants received IVA orally once daily in the evening.
15926405|NCT03447249|Drug|Placebo|Participants received placebo matched VX-659/TEZ/IVA orally once daily in the morning and placebo matched to IVA orally once daily in the evening.
15926406|NCT03447236|Behavioral|Feuerstein Program|Mediated learning cognitive enhancement program
15926407|NCT03447210|Behavioral|Assisted Partner Services|Contact tracing for sexual and drug-sharing partners to notify about exposure to HIV and offer HIV and hepatitis C testing with linkage to care and partner services for those who test positive.
15926408|NCT03447197|Procedure|The use of extracorporeal circulation|The use or not of extracorporeal circulation during the coronary artery bypass procedure.
15926409|NCT03447184|Drug|Androgen priming|"Androgen priming: with a low dose of recombinant hCG, aromatase inhibitor, and a depot GnRHa for 8 weeks Stimulation: a standard rFSH stimulation with either 300 IU rFSH or 300 IU (rFSH + rLH) Blood sampling: 6 blood samples to measure FSH, LH, E2, testosterone, and AMH Ultrasound examination: to count all antral follicles, 2-10 mm in each ovary Follicular fluid: to analyze E2, androstenedione, testosterone, progesterone, inhibin B.
~Granulosa cells: to analyze gene expression in cumulus and mural granulosa cells of Luteinising hormone receptor (LHR), 3β-hydroxy-steroid-dehydrogenase (3ßHSD), inhibin-Ba (INHB-A) receptor, androgen and FSH receptor"
15926410|NCT03447171|Device|App Vision Screening|Using GoCheck Kids App Vision Screening to detect Amblyopia Risk Factors
15926411|NCT03447158|Procedure|15% Dextrose|inject 15% dextrose and xylocaine into subacrominal bursa under sonographically guidance
15926412|NCT03447158|Procedure|Normal saline|inject normal saline and xylocaine into subacrominal bursa under sonographically guidance
15926413|NCT03447145|Drug|TQ-B3203|dose escalation, 2/4/6/10/14/18mg/m2
15926414|NCT03447132|Drug|Fulvestrant 500mg|All patients in all arms will receive Fulvestrant 500mg
15926415|NCT03447132|Drug|Palbociclib 125mg|Dose reduction to 100 mg and 75 mg
15926416|NCT03447132|Drug|Goserelin 3.6 MG|Only for pre or peri menopausal patient
15926417|NCT03447132|Drug|Placebos|Placebo
15926418|NCT03447119|Behavioral|Living Well with a Disability|Implementation of an adapted health promotion program.
15926419|NCT03447106|Procedure|laparotomy|This is a kind of traditional surgical method.
15926420|NCT03447106|Procedure|Laparoscopic|laparoscopic surgery
15926421|NCT03447106|Procedure|Robotic|the Da Vinci robot assisted gastric resection
15926422|NCT03447093|Drug|Methimazole Pill|Patients who developed GD received methimazole treatment
15926423|NCT03447093|Drug|Propylthiouracil Pill|Patients who developed GD received propylthiouracil treatment
15926424|NCT03447080|Other|Control|White Bread containing 50g carbohydrate
15926425|NCT03447080|Other|Control|White Bread containing 50g carbohydrate
15926426|NCT03447080|Other|Ricebran soybean milk|White Bread with rice bran soybean milk
15926427|NCT03447080|Other|Soybean milk|White Bread with soybean milk
15926428|NCT03447067|Procedure|computer guided surgical|has three cutting guided plane for identify the position of place of the third molar, it have beveled cut for stability after remove the teeth and placing the bony window
15926429|NCT03447067|Procedure|Conventional surgery|Low speed motor with surgiacl round burs and surgical fissure for removal a covering bone with decapitation and guttering formation
15926430|NCT03447067|Device|CBCT|For measuring the bone removeal
15926431|NCT03447067|Device|CBCT|for identifed the nerve
15926432|NCT03447054|Behavioral|Combined TDCS active and ICT active|Five 20-minute long sessions including TDCS (2 MicroAmperes during 20 minutes) and ICT, 5 consecutive days
15926433|NCT03447054|Behavioral|Combined TDCS sham and ICT active|Five 20-minute long sessions including TDCS sham (non active) and ICT, 5 consecutive days
15926434|NCT03447054|Behavioral|Combined TDCS active and ICT inactive|Five 20-minute long sessions including TDCS sham and no-cue inhibition training, 5 consecutive days
15926435|NCT03447054|Behavioral|Combined Sham TDCS and inactive ICT|Five 20-minute long sessions including TDCS and no-cue inhibition training, 5 consecutive days
15926436|NCT03447041|Procedure|keratoplasty|"Mark the center of the host cornea with a Sinskey hook. Use calipers to measure the corneal diameter to determine the appropriate size for donor trephine.
~Trephine the donor tissue, typically aiming for 0.25 or 0.5 mm larger than the planned host trephination.
~Trephinate the host cornea to approximately 90% depth.
~Create a paracentesis in the trephination groove or the corneal periphery, and inject Healon into the anterior chamber to preserve anterior chamber depth and stability.
~After using a blade to enter the eye through the trephination groove, resect the host cornea tissue using curved corneal scissors.
~Secure the donor graft to the host corneal tissue using interrupted and/or running 10-0 nylon sutures."
15926437|NCT03447015|Other|ambulation|"Ambulation during labour here will refer to moving from place to place during the first stage of labour that reduces the amount of time a woman spends laying down during this stage (measured by recording the number of minutes spend on walking)."
15926438|NCT03447002|Diagnostic Test|24 hours urine levels metanephrine and normetanephrine|24 hours rhythm recording and 24 hours urine measurement
15926439|NCT03446989|Behavioral|Case management|completing assessment, detecting the presence of RA complications, consultation about taking medications and exercise, education for patients and their family, assist in formulating a management, and providing a basis for continuing care for each patient. Additionally, the management plan was rationally modified in accordance with the individualized therapeutic alliance of the patient, his/her family, the physician or other members of the medical team.
15926440|NCT03446976|Biological|CT-P13 SC Auto-injector|Each subject may receive single dose by subcutaneous administration using Auto-Injector
15926441|NCT03446976|Biological|CT-P13 SC Pre-filled Syringe|Each subject may receive single dose by subcutaneous administration using Pre-filled Syringe
15926442|NCT03446963|Behavioral|Groups for Health|Group sessions, 5 modules x 1.5 hours (once per week). Modules focus on psychoeducation, mapping existing social networks, examining barriers to engagement in existing networks, goal setting and identifying new groups to join.
15926443|NCT03446950|Procedure|Vaginal Surgery|Patients will undergo elective surgery on vagina or bladder
15926444|NCT03446937|Drug|Dexamethasone Sodium Phosphate Injection|Dexamethasone sodium phosphate injection 12 mg X doses to be given 12 hours apart
15926445|NCT03446937|Drug|Betamethasone Sodium Phosphate Injection (Medication)|betamethasone sodium phosphate injection12mg X 2 doses given 12 hours apart
15926446|NCT03446937|Drug|Water for injection|Two doses of intramuscular injection of water for injection given 12 hours apart
15926447|NCT03446924|Dietary Supplement|Phosphatidic Acid|To be administered a single dose of 1.5 g phosphatidic acid in capsule form (250 mg / capsule).
15926448|NCT03446924|Dietary Supplement|Rice flour|Rice flour placebo to be administered a single dose of 1.5 g in capsule form (250 mg / capsule).
15926449|NCT03446911|Radiation|SABR|Prior to surgery (lobectomy), patients receive stereotactic ablative radiotherapy.
15926450|NCT03446911|Combination Product|SABR + pembrolizumab|Prior to surgery (lobectomy), patients receive stereotactic ablative radiotherapy + 2 rounds of pembrolizumab
15926451|NCT03446898|Other|Chronic hypoxic environment|Chronic hypoxic environment. Since the partial pressure of oxygen in inspired air falls with increasing terrestrial elevation above sea level, many physiological variables in adults would be affected by the chronic hypoxia environment.
15926452|NCT03446885|Drug|Lisdexamfetamine Dimesylate 40 MG|Lisdexamfetamine Dimesylate 40 MG administered orally
15926453|NCT03446885|Drug|Placebo|Placebo capsule administered orally
15926454|NCT03446872|Drug|ONIVYDE|irinotecan liposome injection
15926455|NCT03446872|Drug|5-fluorouracil|a nucleoside metabolic inhibitor
15926456|NCT03446872|Drug|Leucovorin|an active metabolite of folic acid
15926480|NCT03446664|Device|Microburst Stimulation|Implantable generator with new stimulation feature under study to determine the safety and effectiveness of device stimulation on different seizure types.
15926512|NCT03446456|Drug|Arginine vasopressin|Intranasal vasopressin will be administered shortly before the fMRI experiment.
15926513|NCT03446456|Other|Saline|Intranasal saline will serve as a placebo for participants in the Saline Arm
15927702|NCT03437278|Drug|Placebo|Placebo 0 mg per 1 ml liquid injection once every 4 weeks.
15926457|NCT03446859|Other|TENS|"First, there was explanation of the overall test procedure. The subject was placed in supine lying in a comfortable position.A pair of electrodes (inactive electrodes) was placed a little below the umbilicus (Right and Left) and the other pair (active electrode) along the inguinal region at the level of pubic symphysis (Right and Left) according to (Akinbo et al 2000).
~The TENS equipment was switched on and the intensity was set at a level tolerable by each participant's. The treatment period lasted for 30 minutes for each treatment sessions and the procedure was carried out once a day on the 1st, 3rd and 5th days (Akinbo et.al 2000). Pain intensity was measured pre treatment and post treatment each day of treatment using the visual analogue scale (VAS)."
15926458|NCT03446846|Drug|MIN-117 5.0 mg|5.0 mg MIN-117 administered as two MIN-117 2.5 mg capsules as a single dose once daily
15926459|NCT03446846|Drug|MIN-117 2.5 mg|2.5 mg MIN-117 administered as one MIN-117 2.5 mg capsule and one Placebo capsule as a single dose once daily
15926460|NCT03446846|Drug|Placebo|Placebo administered as two Placebo capsules as a single dose once daily
15926461|NCT03446833|Device|The LFP Beta aDBS System|The LFP Beta aDBS System is intended for use in patients receiving DBS for Parkinson's Disease where LFPs may be recorded and analyzed.
15926462|NCT03446820|Other|hygro cotton sheets|hygro cotton sheets will be utilized to impact microclimate
15926463|NCT03446807|Drug|Droxidopa|Droxidopa in 100, 200, and 300mg capsules. Maximum dose to be used in this study is 600mg.
15926464|NCT03446807|Drug|Placebo Oral Tablet|Placebo capsules to match Droxidopa 100, 200, and 300mg capsules.
15926465|NCT03446794|Other|Non Intervention|To assess the procedural safety and efficacy on stroke and bleeding prevention of LAAC in patients with NVAF and ESCKD on HD
15926466|NCT03446781|Biological|EN3835|Collagenase clostridium histolyticum
15926467|NCT03446781|Biological|Placebo|Placebo
15926468|NCT03446768|Other|Peer support|Access to educational and informational support by a trained peer coach
15926469|NCT03446768|Other|Online platform|An online platform that provides educational, informational and access to several therapeutic device metrics
15926470|NCT03446768|Other|Respiratory Therapist support|Limited medical support provided by trained Respiratory Therapists.
15926471|NCT03446755|Device|intra uterine Cook balloon|Insertion of a hearth shaped intrauterine balloon immediately after hysteroscopic adhesiolysis and left in place for 7 days under antibiotic prophylaxis.
15926472|NCT03446742|Other|Cardiovascular rehabilitation|The cardiovascular rehabilitation program is performed three times weekly on alternate days and each session lasts approximately 60 minutes divided as follows: 5 minutes to the initial rest where blood pressure (BP), heart rate (HR) and signs and symptoms are assessed; 15 minutes of warm-up, composed by global stretches, lower and upper limb exercises, and exercises combining the two modes; then, patients go to the resistance phase (30 minutes), where are performed an individualized aerobic protocol according to their HR reserve values using bicycle and treadmill (at the 4th and 10th minute of both ergometers at HR is evaluated, and in the bicycle is also evaluated the BP of all the patients). The end of the protocol is composed of 10-minute relaxation, during which the patients perform a small cardiovascular deceleration (a few laps around the room, with free speed) and, finally, lie down at rest. The presence of signs and symptoms is assessed at all stages of the program.
15926473|NCT03446729|Behavioral|Guided Self-Help Behavioral Weight Loss|Guided self-help Behavioral Weight Loss including 7 visits over 12 weeks. The treatment content includes self-monitoring, healthy eating, stimulus control, increasing physical activity, reducing sedentary activity, planning ahead for high-risk situations, and relapse prevention. The 7 visits are conducted with a behavioral coach to give participants educational materials and to promote accountability. The behavioral coach's role in the gshBWL program is to measure participant weight, collect self-monitoring booklets, clarify materials, and problem-solve barriers to adherence.
15926474|NCT03446716|Behavioral|Sleep Extension|Child attempted to go to bed 90 mins in advance of their normal bedtime.
15926475|NCT03446703|Behavioral|SCIT|SCIT is a 18 weekly sessions lasting 45-60 minutes per session. The group will include 8-12 patients, with 2 therapists. The content of the sessions is based on the Spanish translation of the original SCIT (Social Cognition and Interaction Training) instruction manual (Combs, Adams, et al., 2007); (G. Lahera et al., 2013). The manual of the program developed for the improvement of emotional perception skills, attributional style and theory of mind in people with schizophrenia.
15926476|NCT03446703|Behavioral|TAR|TAR is a 12-session training on facial affect recognition over a period of 6 weeks. Treatment includes one therapist (psychiatrist or clinical psychologist) and 2 patients. It involves neuropsychological strategies, such as restitution and compensation, as well as principles of errorless learning, direct positive reinforcement, verbalization and self-instruction (Frommann et al., 2003; Wölwer et al., 2005).
15926477|NCT03446690|Drug|MI Varnish|MI Varnish with RECALDENT™ (CPP-ACP) enhances enamel acid resistance and boosts salivary fluoride levels. This product remains on the teeth longer than other fluoride varnishes and contains high levels of fluoride and calcium released in the oral cavity. The difference is in the RECALDENT™ (CPP-ACP), which makes MI Varnish a natural and unique choice for your patients. Casein phosphopeptides (CPP) naturally occurs in milk casein; Amorphous Calcium Phosphate (ACP), which is found in the RECALDENT™, is also the source of calcium and phosphate. In the oral cavity, CPP binds to oral surfaces such as teeth, dentin, oral mucosa and biofilm. Calcium and phosphate ions are the building blocks for healthy teeth and MI Varnish delivers bioavailable calcium and phosphate ions into the saliva.
15926478|NCT03446690|Other|Control group|Participants received routine treatment and oral hygiene regimes. No intervention for this group.
15926479|NCT03446677|Other|Postural Stability Testing|Each subject was instructed to stand in a static bipedal posture on the MatScan® pressure mat and performed 8 balance tasks. Data of center of pressure, antero-posterior sways and medial-lateral sways were collected in each of the conditions. Each task took 30 seconds to be performed. The first 4 tasks were performed with the mat on the hard surface of the floor. These 4 tasks are as follows: standing with eyes open, standing with eyes closed, standing with eyes open looking and actively moving head upward and downward, and standing with eyes closed and the head actively moving upward and downward. The subjects were asked to perform four more tasks while standing on a thick piece of balance foam that was placed on top of the MatScan®. The remaining 4 tasks are as follows: standing with eyes open, standing with eyes closed, standing with eyes open looking and actively moving the head upward and downward, and standing with eyes closed with head actively moving upward and downward.
15926481|NCT03446651|Drug|Lysine Chloride|Patients will receive 7 days of therapy using 115 mmol/day of lysine chloride. Patients will be given the option of a taste test of both lysine chloride & the placebo powders mixed with various beverages to ensure it is palatable to them. If the patient feels they will not be able to take the study medication twice a day due to taste, they will be withdrawn from the study at this time.
15926482|NCT03446651|Other|Placebo|Patients will receive 7 days of therapy using placebo. Patients will be given the option of a taste test of both lysine chloride & the placebo powders mixed with various beverages to ensure it is palatable to them. If the patient feels they will not be able to take the study medication twice a day due to taste, they will be withdrawn from the study at this time.
15926483|NCT03446638|Drug|FDA-approved drug or combination of drugs|Patients assigned to this arm will receive an FDA-approved drug or combination of drugs. Dosing and treatment schedule will follow the package insert for the selected drug(s).
15926484|NCT03446638|Drug|FLAG induction|Patients will receive 30 mg/m2 per day intravenously of fludarabine for 5 days and 2000 mg/m2 per day intravenously of cytarabine for 5 days. 5 mg/kg per day of granulocyte colony stimulating factor (G-CSF) may be given subcutaneously beginning on Day 1 of each treatment until absolute granulocyte count > 500/ microliter for 3 days.
15926485|NCT03446638|Drug|7 + 3 induction|Patients will receive 100-200 mg/m2 per day intravenously of cytarabine for 7 days, plus either 45-60 mg/m2 per day intravenously of daunorubicin or 9-12 mg/m2 per day intravenously of idarubicin for 3 days.
15926486|NCT03446638|Drug|Low-dose cytarabine|Patients will receive 20 mg/m2 per day subcutaneously of cytarabine for 10 days every 28 days.
15926487|NCT03446638|Other|Supportive care alone|Patients will receive one or more of the following: blood product transfusions, antibiotics, granulocyte colony-stimulating factor (G-CSF), erythropoietic stimulating factors, and iron chelation.
15926488|NCT03446638|Device|Computational biology simulations software|Genetic testing results for each patient randomized to this arm will be used by a computational biology simulations software program to generate a personalized map of dysregulated metabolic pathways contributing to the patient's disease. This map will then be used to digitally screen for potentially therapeutic FDA-approved drugs or drug combinations to target the dysregulated metabolic pathways.
15926489|NCT03446625|Drug|Resveratrol|Resveratrol treatment (2 g/day) will be administered for 9 days, starting from oocyte maturation day.
15926490|NCT03446625|Drug|Placebo|Placebo treatment (2 g/day) will be administered for 9 days, starting from oocyte maturation day.
15926491|NCT03446612|Drug|Daprodustat|Daprodustat will be available as 1 mg, 2 mg and 4 mg oral tablets. Daprodustat will be administered once daily by oral route without regard for food.
15926492|NCT03446612|Drug|Darbepoetin alfa|Darbepoetin alfa will be given as solution for injection for subcutaneous administration every 2 weeks.
15926493|NCT03446612|Drug|Acetylcholine|Acetylcholine will be used as a challenge agent and will be infused at 7.5, 15 and 30 micrograms/minute each for 6 minutes per infusion into the brachial artery of the test arm.
15926494|NCT03446612|Drug|Sodium nitroprusside|Sodium nitroprusside will be used as a challenge agent and will be infused at 3 and 10 micrograms/minute each for 6 minutes per infusion into the brachial artery of the test arm.
15926495|NCT03446612|Drug|L-N-monomethyl arginine acetate (L-NMMA)|L-N-monomethyl arginine acetate will be used as a challenge agent and will be infused at a doses of 2 and 8 micromoles/minute for 6 minutes into the brachial artery of the test arm.
15926496|NCT03446599|Drug|Hydroxocobalamin|One intravenous dose of 5mg hydroxocobalamin, which is the current FDA-approved adult dose for carbon monoxide poisoning, reconstituted in 200ml normal saline will be administered over 10-15minutes at the time of initiation of cardiopulmonary bypass.
15926497|NCT03446599|Drug|Methylene Blue|One intravenous dose of methylene blue 2mg/kg, which has been the accepted dose for vasoplegia, diluted in 200ml normal saline will be administered over 10-15minutes at the time of initiation of cardiopulmonary bypass.
15926498|NCT03446599|Drug|Normal saline|200ml normal saline will be administered intravenously over 10-15minutes at the time of initiation of cardiopulmonary bypass.
15926501|NCT03446560|Device|CPAP, conventional follow up|Positive airway pressure to splint the airway and to prevent apneas during sleep. Follow up of patients after initiation of treatment according to clinical routine at the study site. Patients are informed to call or visit the sleep center in case of problems with the CPAP device. At 3 months a follow up visit is scheduled at the sleep center. CPAP compliance data will be downloaded and all patients fill in a number of questionaires related to the CPAP treatment effects on sleep apnea symptoms and health related quality of Life. Mask fitting will be tested.
15926502|NCT03446560|Device|CPAP, telemedicine based follow up|Follow up of patients by means of a telemedicine solution for surveillance of CPAP treatment, Compliance with and efficacy of CPAP can be followed up by the sleep center personnel on a regular basis. Patients with low compliance and mask fitting problems will be contacted by phone. At the end of the 3 months period a visit at the sleep center will be scheduled only for patients with low compliance, low treatment efficacy, or high mask leakage. All patients will be asked to fill in a number of questionaires related to CPAP treatment effects on sleep apnea symptoms and health related quality of Life.
15926503|NCT03446547|Drug|Durvalumab|durvalumab 1500 mg i.v. every fourth week for 12 months
15926504|NCT03446534|Drug|Amoxicillin|Imacillin mixture
15926505|NCT03446534|Drug|Placebos|Placebo manufactured to mimic amoxicillin mixture (Imacillin)
15926506|NCT03446508|Device|Active frontal|1) active HD-tDCS will be administered
15926507|NCT03446508|Device|Active parietal|2) active HD-tDCS will be administered
15926508|NCT03446508|Device|Sham|3) sham HD-tDCS - no current
15926509|NCT03446495|Drug|Trabectedin + PLD|Combination of Trabectedin + PLD: PLD 30 mg/m2 intravenous (IV) infusion over 90 minutes + trabectedin 1.1 mg/m2 IV infusion over 3 hours every 3 weeks.
15926510|NCT03446482|Other|observation of differents tasks|Evaluation by an external observer (nurse student in research stage or clinical research technician) of the distribution of medical time for the performance of the different tasks of anesthesiologist (in minutes)
15926511|NCT03446469|Other|Fascial Manipulation|Myofascial release of densified centers of coordination
15926514|NCT03446456|Behavioral|Observational learning|During the observational learning intervention, participants will learn the experience of analgesia in another person via a video. Participants will learn the analgesia nature of the placebo cream and the neutral nature of the control cream.
15926515|NCT03446443|Drug|Honghe Fujie lotion|Before application，wash the vaginal area with water and dry it. Take10ml Hong He Fujie into dilution bottles，added to 100ml with warm boiled water, using diluted lotion for the rinse of vulva and vagina, twice daily for 7days.
15926516|NCT03446443|Drug|Metronidazole Suppositories|Before bedtime，wash the vaginal area and put 0.5g Metronidazole Suppositories into posterior vaginal fornix，once daily for 7days.
15926517|NCT03446430|Device|PWV measurement by LDV|PWV measurement by LDV : carotid-femoral, carotid and chest-carotid
15926518|NCT03446417|Drug|ZN-e4|Oral dose, tablet, daily dosing
15926519|NCT03446404|Diagnostic Test|Standing Computed Tomography|Provides weight bearing 3D view of knees.
15926520|NCT03446391|Procedure|Kinematic alignment|The principle for kinematically aligning the femoral component is to remove the correct amount of bone and cartilage from the distal and posterior femur after accounting for wear and saw blade kerf, so that the total thickness of the missing and removed tissue matches the thickness of the femoral component.
15926521|NCT03446391|Procedure|Mechanical alignment|Classic mechanical alignment (MA) in total knee arthroplasty (TKA) is meant to co-align the prosthetic components to the mechanical axes of the femur and tibia and restore neutral overall limb alignment
15926522|NCT03446391|Device|GMK Sphere®|The GMK Sphere® is a total knee prosthesis . The design of the GMK Sphere® is characterized by a spherical medial femoral condyle and an asymmetrical fixed tibial UHMWPE polyethylene insert with a concave spherical medial compartment.
15926523|NCT03446378|Device|Anodal tDCS|tDCS involves application of very low-amplitude direct currents (2 mA or less) via surface scalp electrodes. It produces a sub-sensory level of electrical stimulation wich remains imperceptible by most people during application. In a small percentage of patients, it may cause minimal discomfort with a mild tingling sensation, which usually disappears after a few seconds. Depending on the polarity, tDCS can increase or decrease corticomotor excitability. Anodal tDCS is able to facilitate neurons depolarization - increasing cortical excitability - while, on the other hand, cathodal tDCS hyperpolarizes the resting membrane potential, reducing the neuronal firing and the cortical excitability questionnaire will be applied
15926524|NCT03446378|Behavioral|Physical therapy|all patients will be submitted to a protocol of exercise with differents levels according with motor learing and neuroplasticity principles. All physical therapists were trained before the study.
15926525|NCT03446378|Device|Cathodal tDCS|tDCS involves application of very low-amplitude direct currents (2 mA or less) via surface scalp electrodes. It produces a sub-sensory level of electrical stimulation wich remains imperceptible by most people during application. In a small percentage of patients, it may cause minimal discomfort with a mild tingling sensation, which usually disappears after a few seconds. Depending on the polarity, tDCS can increase or decrease corticomotor excitability. Anodal tDCS is able to facilitate neurons depolarization - increasing cortical excitability - while, on the other hand, cathodal tDCS hyperpolarizes the resting membrane potential, reducing the neuronal firing and the cortical excitability questionnaire will be applied
15926526|NCT03446378|Device|Sham tDCS|tDCS involves application of very low-amplitude direct currents (2 mA or less) via surface scalp electrodes. It produces a sub-sensory level of electrical stimulation wich remains imperceptible by most people during application. In a small percentage of patients, it may cause minimal discomfort with a mild tingling sensation, which usually disappears after a few seconds. Depending on the polarity, tDCS can increase or decrease corticomotor excitability. Anodal tDCS is able to facilitate neurons depolarization - increasing cortical excitability - while, on the other hand, cathodal tDCS hyperpolarizes the resting membrane potential, reducing the neuronal firing and the cortical excitability questionnaire will be applied
15926527|NCT03446365|Behavioral|ASMAS|A high school peer led group intervention for middles school students targeting asthma education and asthma management practices.
15926528|NCT03446365|Behavioral|Asthma education plus child health|Health educator led intervention focused on asthma education and other child health topics.
15926529|NCT03446352|Other|Psychomotor exercise program|"Each session includes: beginning ritual (5 min), warm-up (15 min), main section comprising the multimodal exercises (40 min), cool-down (10 min), and finishing ritual (5 min).
~At the initial stage, the activation of different muscle groups will be performed, providing an elevation of the neurophysiological parameters. The main section (multimodal exercises) will be focused on the specific objectives through sensorimotor and neurocognitive activities. This section includes periods ranging 10-15 min of exercises mainly focused on motor stimulation- physical performance (cardiovascular, strength, balance, flexibility, agility and movement accuracy)- alternating with exercises mainly focused on cognitive stimulation- executive functions (planning ability, information processing speed, attention and dual-task performance).
~At the cool-down the participants will normalize their physiological parameters. Finally, at the finishing ritual the participants share their sensations experienced."
15926530|NCT03446352|Other|Combined exercise program|"The EG2 intervention combines the psychomotor exercise program with a WBV program. The program integrates 3 sessions / week of 75 minutes (including the 6 minutes of WBV) on alternated days.
~The WBV will integrate 3 sessions / week of 6 minutes each, with programed increased exercise time, series, and frequencies throughout the intervention."
15926531|NCT03446326|Device|Pacing|Assess the non-invasively determined stroke volume and cardiac output response at different paced heart rates in patients with a cardiac pacemaker or implanted defibrillator with preserved ejection fractions (LVEF≥50%)
15926532|NCT03446313|Behavioral|Movn Mobile App|The Movn app will have each participant's personalized instructions for post-cardiac rehab integrated into it including medication reminders, physical activity prompts, educational materials, and patient-reported outcomes.
15926533|NCT03446274|Drug|Evenamide|This is an orally available small molecule that potently blocks voltage-gated sodium channels (VGSCs) in vitro and is indicated for the treatment of patients with schizophrenia, mania, and bipolar disorder.
15926534|NCT03446261|Drug|Rosuvamibe® Tab|Rosuvastatin 5mg/ezetimibe 10mg qd for 8 weeks
15926535|NCT03446261|Drug|Monorova® Tab|Rosuvastatin 10mg qd for 8 weeks
15926626|NCT03445546|Diagnostic Test|diagnostic test of platelet function|Light transmittance aggregometry and VerifyNow
15928247|NCT03433079|Diagnostic Test|Arterial lactate|Arterial lactate level was assessed in all patients.
15926536|NCT03446248|Device|Corometrics-146 device|Fetal vibroacoustic stimulation with the Corometrics-146 fetal acoustic stimulator will be performed by placing the device on the maternal skin halfway between the pubic symphysis and the umbilicus and activating the device for 3 seconds.
15926537|NCT03446248|Device|Mobile phone application|Fetal vibroacoustic stimulation with the mobile phone will be performed by placing and iPhone on the maternal skin halfway between the pubic symphysis and umbilicus and using the application to activate for 3 seconds the phone's built in vibration along with a 2,000 Hz tone at a sound level of 74 decibels when measured at 1 meter.
15926538|NCT03446235|Behavioral|Exercise instruction with motivational interview|An activity tracker and a heart rate monitor to track the participants activity and exercise records will be used. In addition to the basic instruction of exercise and nutrition, an exercise physiologist provides individualized exercise instruction with a motivational interviewing skill, which is a different style from traditional persuasive style of communication between the healthcare professionals and patients.
15926539|NCT03446235|Behavioral|Self-monitoring|An activity tracker and a heart rate monitor to track the participants activity and exercise records will be used. Basic instruction about exercise and nutrition is provided at the initial visit.
15926540|NCT03446222|Procedure|Catheter ablation|Catheter based radiofrequency ablation with wide antral circumferential PVI and isolation of posterior wall will be performed. Mitral and cavo-tricuspid isthmus ablation will be done only if such isthumus dependent flutters are documented prior to / during the procedure.
15926541|NCT03446222|Procedure|Mini-maze surgical procedure|Wolf Mini-maze surgical ablation along with left atrial appendage ligation will be performed.
15926542|NCT03446209|Drug|Tocilizumab Infusion RoAcemtra (EU)|Experimental arm's patients will obtain TCZ intravenously once every 4 weeks for 28 weeks
15926543|NCT03446209|Drug|0.9% physiological saline|"Experimental arm's patients will obtain saline intravenously once every 4 weeks for 16 weeks. If necessary, patients will get rescue medication after week 16 to week 28."
15926544|NCT03446196|Device|Fluid replacement based on MOSTCARE up|Clinician will be able to read MOSTCARE parameters and to choose the best treatment to adequate hemodynamics considering that current literature suggests a fluid IV expansion only if PPV > 12%
15926545|NCT03446183|Behavioral|Smoking cessation workshops|All the participants took part in smoking cessation workshops. The comparison of metabolic aspects was made between the smokers and non-smokers
15926546|NCT03446170|Behavioral|Graphic cigarette warning labels, plain packaging|This study tests the effects of graphic cigarette warning labels that include pictures and text, and plain or standardized packaging
15926547|NCT03446157|Drug|Cetuximab|Loading dose on day 1 of week 1 of 400 mg/m2 via IV over 2 hours Subsequent doses of 250 mg/m2 via IV over 1 hour weekly for 4 weeks (28 days) in combination with palbociclib
15926548|NCT03446157|Drug|Palbociclib|125 mg taken orally once daily on days 1-21, then 7 days off
15926549|NCT03446144|Drug|IONIS-FB-Lrx|Single Dose of IONIS-FB-Lrx administered once weekly for weeks 1-3, and every other week or less frequently until week 70
15926550|NCT03446144|Drug|Placebo (sterline saline 0.9%)|Calculated volume to match active comparator. Administered subcutaneously weekly for weeks 1-3, and every other week or less frequently until week 70
15926551|NCT03446118|Device|MRI to detect inflammation and fibrosis in subjects with EoE|MRI will be performed on a 1.5T magnet. Patients will be scanned in an oblique prone position similar to how esophageal distention is assessed at barium fluoroscopy
15926552|NCT03446105|Behavioral|App-based behavioral intervention|Achieving Wellness After Kancer in Early life (AWAKE) is a behavioral intervention that includes a smartphone app and coaching. AWAKE contains eight modules, and participants will complete the one module every week. App functioning will facilitate weekly homework assignments and include health education messaging, the ability to track progress toward goals over time via self-monitoring and graphical depictions of progress, audio-recordings of guided imagery exercises and relaxation exercises (e.g., progressive muscle relaxation), videos of topic-related inspirational material, and a portal for interacting with the coach. The coach will call each intervention participant weekly. Each coaching session will last roughly 30 minutes and involve four segments that will correspond to the module for the week. The coach will send daily text messages to participants encouraging their goal pursuits and providing other sources of support related to that week's homework.
15926553|NCT03446105|Behavioral|Attention control group|The attention control group will receive the same components as the intervention group, but the educational modules will contain different content than those receiving the AWAKE intervention.
15926554|NCT03446092|Behavioral|Mindfulness for health|A course of mindfulness using the mindfulness for health programme.
15926555|NCT03446079|Other|Topical Anti Aging Cream|Primary Subjects will take a saliva based genetic test and apply a topical anti aging cream for 6 weeks.
15926558|NCT03446040|Biological|BMS-986258|Specified dose on specified day
15926559|NCT03446040|Biological|Nivolumab|Specified dose on specified day
15926560|NCT03446040|Drug|rHuPH20|Specified dose on specified days
15926561|NCT03446027|Device|NMES|NMES device to be used for up to 3 hours daily in 30 minute sessions for 3 months.
15926562|NCT03446014|Device|Fitbit Sub-Study|
15926563|NCT03446001|Drug|TRx0237 16 mg/day|Oral TRx0237 4-mg tablets administered twice daily
15926564|NCT03446001|Drug|Placebo|Oral placebo tablets (some of which contain a urinary discolorant) administered twice daily
15926565|NCT03446001|Drug|TRx0237 8 mg/day|Oral TRx0237 4-mg tablet administered twice daily
15926566|NCT03445988|Behavioral|Cognitive Behavioral Therapy|A trained psychologist delivers pain-CBT to individual patients or groups of patients with chronic pain. Group treatment is delivered across 8 weekly sessions that last for 2 hours each. Pain-CBT incorporates interactive discussion, practice of relaxation training, action planning, and home exercises into each session. Pain-CBT is effective for reducing pain intensity, pain catastrophizing, depression and social impacts.
15926627|NCT03445533|Drug|Ipilimumab|4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 1, 4, 7, and 10.
15926628|NCT03445533|Drug|IMO-2125|IMO-2125 intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 16, 20, and 24.
15958661|NCT03198013|Drug|Prednisolone|Specified dose on specified days
15926567|NCT03445988|Behavioral|Chronic Pain Self Management Program|The CPSMP is similar to pain-CBT in format and content but is peer-led, and is effective across pain conditions (e.g., back pain, arthritis) for improving pain and pain self-efficacy. The CPSMP consists of six weekly 2-hour group sessions in which two peer co-leaders provide patient education about pain, effective self-management, pain impacts, and other symptoms from a highly structured manual. Similar to pain-CBT, CPSMP incorporates interactive discussion, practice of relaxation training, action planning, and home exercises into each session
15926568|NCT03445988|Other|Usual Care|Participants allocated to 'Taper Only' will engage in a physician-guided, patient-centered opioid tapering program without additional behavioral intervention.
15926569|NCT03445975|Procedure|3-in-1 perineal care washcloths|The 3-in-1 washcloth was used for daily routine perineal skin hygiene and after each diaper/underpad change. This procedure was intended for cleansing, moisturizing, and application of a barrier protection (dimeticone 3%). 3-in1 washcloths pH range is 3.5 to 5.0.
15926570|NCT03445962|Diagnostic Test|Assessment of OSAS predictive factors|"All subjects of the two groups realized the same assessment:
~Anthropometric evaluation
~biological examination (hormonal, inflammatory and complete blood count, and lipidic profile)
~rest electrocardiogram
~motor assessment (strenght, flexibility and balance)
~actigraphy
~Autonomic nervous system assessment during sleep
~Autonomic nervous system assessment during head up tilt test before and after physical exercise
~maximal treadmill test (VO2 max measure)
~polysomnography
~seismocardiography
~questionnaires :sleep and physical activity"
15926571|NCT03445949|Drug|short postimplantation dual antiplatelet therapy|continuing dual antiplatelet therapy up until 6 months after left atrial appendage occlusion with Amplatzer Amulet
15926572|NCT03445949|Drug|extended postimplantation dual antiplatelet therapy|stopping dual antiplatelet therapy after 30 days after left atrial appendage occlusion with Amplatzer Amulet and continuing single antiplatelet agent up until 6 months
15926573|NCT03445936|Device|Parietene Macro|Parietene Macro is placed and sutured on retro muscular space on closed posterior rectus sheath to prevent incisional hernia.
15926574|NCT03445936|Device|Permacol|Permacol biologic implant is placed and sutured on retro muscular space on closed posterior rectus sheath to prevent incisional hernia.
15926576|NCT03445910|Drug|Human chorionic gonadotropin|intrauterine injected of 500 IU of hCG on the day of ovum pick-up and
15926577|NCT03445897|Drug|miltefosine plus intralesional pentamidine|miltefosine (150 mg/day for 28 days) plus intralesional pentamidine (120 ug/mm2 lesion area on days 1, 3, and 5).
15926578|NCT03445884|Drug|68Ga-NODAGA-E[c(RGDyK)]2|200 MBq 68Ga-NODAGA-E[c(RGDyK)]2 administered IV.
15926579|NCT03445871|Biological|Blood sample|Blood samples will be collected for measuring PG-MTX blood concentration.
15926580|NCT03445871|Diagnostic Test|CRQ|Compliance Rheumatology Questionnaire (CQR) is a self-administered questionnaire for to evaluate therapeutic observance during rheumatoid arthritis.
15926581|NCT03445858|Drug|Pembrolizumab|Patients will receive pembrolizumab every 28 days.One cycle lasts 28 days. Cycles may repeat for a total of 26 cycles if patient meets criteria to continue protocol therapy.
15926582|NCT03445858|Drug|Decitabine|Patients will receive decitabine every 28 days.One cycle lasts 28 days. Cycles may repeat for a total of 26 cycles if patient meets criteria to continue protocol therapy.
15926583|NCT03445858|Radiation|Hypofractionated Index Site Radiation|Patients will receive a single 3 day course of fixed-dose hypofractionated radiotherapy to one or more index lesions during the first cycle only.
15926584|NCT03445845|Drug|Secukinumab|Secukinumab : 150 mg per week for 5 weeks, and then every month by subcutaneous injection
15926585|NCT03445845|Drug|TNF blocker|"TNF blocker (originator or biosimilar) :
~infliximab: 5mg/kg per IV infusion at weeks 0, 2, 6, and then every 6 weeks,
~etanercept: 50mg per week in subcutaneous injection,
~adalimumab: 40mg every other week in subcutaneous injection,
~certolizumab: 400mg every other week 3 times, and then 200mg every other week or 400mg per month in subcutaneous injections,
~golimumab: 50mg every month in subcutaneous injection, in case of overweight (>100kg) an inadequate response, 100mg every month is allow."
15926586|NCT03445845|Biological|blood specimen|Blood specimen at each visits for measurement of bDMARS blockers concentration and anti-drug antibody concentration
15926587|NCT03445819|Procedure|Group A: Surgical Treatment|Open reduction and internal fixation (ORIF) of the patellar fracture will be performed using screws, wires, pins, or plate fixation at the discretion of the treating surgeon
15926588|NCT03445819|Other|Group B: Conservative Treatment|Patients randomized to non-operative treatment will receive identical treatment to the operative group, minus the surgery.
15926589|NCT03445780|Drug|Ethyl chloride spray|Skin cooling with ethyl chloride spray 5 seconds prior to injection
15926590|NCT03445780|Procedure|Pinching|Skin between the distal palmar crease and the palmo digital crease will be pinched for 5 seconds prior to injection
15926591|NCT03445780|Procedure|No Site of Procedure|Subjects will sit behind a screen with a small opening large enough to introduce the injected hand. They will not see any of the procedure
15926592|NCT03445767|Other|MedSafer|An electronic deprescribing intervention that identifies potentially inappropriate medications (PIMs) and generates instructions for safe discontinuation. These recommendations are presented to the treating physicians for their consideration.
15926593|NCT03445754|Device|TVS|Active TVS will be performed by use of a Tragus stimulator device with electrodes attached to the tragus of the ear. Stimulator will be applied continuously for 1 hour
15926594|NCT03445754|Device|Sham TVS|Device will be applied but not to the Tragus of the ear but will be attached to the ear lobule.
15926595|NCT03445741|Other|Supervised treadmill group (%70 VO2 max) (group 1)|An exercise prescription was developed for each woman on the basis of the data acquired from the baseline treadmill exercise test. Target heart rate (HR) corresponding to values of 70% VO2max were determined by the submaximal treadmill test. The participants were instructed walking at their target HR on a treadmill in Sports Rehabilitation Unit of Pamukkale University. HR was monitored by a Polar HR monitor (Polar Beat, Port, Washington, NY). During 12 weeks, 3 days in a week and 20 minutes per day walking program was applied.
15926629|NCT03445533|Drug|Ipilimumab|Ipilimumab administered as 4 doses on Weeks 2, 5, 8, and 11.
15926596|NCT03445741|Other|Supervised treadmill group (%50 VO2 max) (group 2)|An exercise prescription was developed for each woman on the basis of the data acquired from the baseline treadmill exercise test. Target heart rate (HR) corresponding to values of 50% VO2max were determined by the submaximal treadmill test. The participants were instructed walking at their target HR on a treadmill in Sports Rehabilitation Unit of Pamukkale University. HR was monitored by a Polar HR monitor (Polar Beat, Port, Washington, NY). During 12 weeks, 5 days in a week and 30 minutes per day walking program was applied.
15926597|NCT03445741|Device|ECE PEDO pedometer group (%50 VO2 max) (group 3)|Target heart rate (HR) corresponding to values of 50 % VO2max were determined by the submaximal treadmill test. The number of steps taken in a minute corresponding to target HR was determined by a criterion pedometer and group 3 was instructed walking in this step range recorded to ECE PEDO giving audible feedback. During 12 weeks, 5 days in a week and 30 minutes per day walking program was applied.
15926598|NCT03445728|Drug|Nicorandil|After randomization, receive primary PCI and standard therapy, 12mg Nicorandil iv. just before ballooning or stenting, then keep Nicorandil 6mg/h ivgtt. up to 24h
15926599|NCT03445728|Other|Placebo|After randomization, receive primary PCI and standard therapy, just like the intervension group also iv. just before ballooning or stenting, then keep ivgtt. up to 24h
15926600|NCT03445715|Genetic|ART-I02|Single Intra-articular injection in the wrist joint
15926601|NCT03445702|Drug|Metformin|Metformin 1000mg once
15926602|NCT03445702|Drug|Placebo|Sugar pill manufactured to mimic metformin 1000mg
15926603|NCT03445689|Other|Assessment of oxygenation instability|Recordings of SpO2 and heart rate will be analyzed by dedicated software to obtain frequency, duration and severity of episodes of hypoxemia and hyperoxemia.
15926604|NCT03445689|Other|Determination of mechanisms of hypoxemia episodes|Recordings of SpO2, heart rate, esophageal pressure, tidal volume, minute volume, respiratory rate and transcutaneous PCO2 will be analyzed to determine the prevalence, severity and duration of hypoxemia episodes produced by the different mechanisms.
15926605|NCT03445689|Other|Assessment of respiratory instability|Recordings of tidal volume, minute volume and respiratory rate will be analyzed to determine frequency of apnea, periodic breathing, distribution of inter-breath intervals.
15926606|NCT03445689|Other|apneic threshold of CO2|In mechanically ventilated infants the apneic threshold of CO2 will be measured by transcutaneous PCO2 following a step wise increase in ventilator rate until spontaneous breathing ceases transiently. In spontaneously breathing infants the apnea threshold of CO2 will be measured during episodes central apnea.
15926607|NCT03445689|Other|Assessment of peripheral chemoreceptor function|The Dejours test will be used to assess peripheral chemoreceptor function by measuring the immediate ventilatory response to high-inspired oxygen.
15926608|NCT03445689|Other|Assessment of central chemo-receptor function|Central chemo-receptor function will be assessed by measuring the ventilatory response to inspired CO2.
15926609|NCT03445676|Behavioral|ABHR directly on gloves|HCW will be directed by study personnel to use alcohol-based hand rub (ABHR) to cleanse gloves at each hand hygiene opportunity
15926610|NCT03445663|Drug|AMG 424|Subjects will receive IV infusions of AMG 424
15926611|NCT03445650|Drug|ADX-102 1% Topical Dermal Cream (reproxalap)|ADX-102 1% Topical Dermal Cream administered approximately every 24 hours for 6 months in Part 1 and Part 2.
15926612|NCT03445650|Drug|Vehicle of ADX-102 Topical Dermal Cream|Vehicle of ADX-102 Topical Dermal Cream administered approximately every 24 hours for 6 months in Part 1 and Part 2.
15926613|NCT03445624|Drug|Infliximab|follow up the patients who received this drugs for 1 year by abdominal ultrasound,peripheral hemogram and colonoscopy
15926614|NCT03445611|Drug|corticosteroid solution with lidocaine containing parabens.|To identify whether corticosteroid use with anesthetics containing parabens reduces clinical effectiveness relative to para-free preparations.
15926615|NCT03445611|Drug|corticosteroid solution with lidocaine containing no paraben|To identify whether corticosteroid use with anesthetics containing parabens reduces clinical effectiveness relative to para-free preparations.
15926616|NCT03445598|Behavioral|Interactive and personalized CCBT|Participants will go through an automated program. Participants will learn and practice the techniques of CBT through multimedia elements along with personalized content and interactive features in the program
15926617|NCT03445598|Behavioral|Feature-limited CCBT|Participants will be going through an automated program. Participants will learn and practice the techniques of CBT in a plain-text format with reduced features.
15926618|NCT03445598|Other|Waitlist control|Participants will be put on a waitlist for a period of 6 weeks.
15926619|NCT03445572|Other|Best Practice|Receive standard supportive care
15926620|NCT03445572|Procedure|Meditation Therapy|Perform MSB
15926621|NCT03445572|Procedure|Meditation Therapy|Perform IK meditation
15926622|NCT03445572|Other|Questionnaire Administration|Ancillary studies
15926623|NCT03445559|Behavioral|Clinical Order Check|A Clinical Order Check is an evidence-based, systems-level method to affect significant behavior change. It addresses the intervention functions of education, enablement and incentivization which are effective methods to change behaviors driven by beliefs about capabilities, knowledge, social influences, beliefs about consequences, and environmental context and resources. All VA facilities currently use locally adapted clinical reminders. This strategy is technologically simple, straightforward, and is considered to be a best practice within the VA IT community. The reminder will be self-explanatory and non-intrusive to workflow.
15926624|NCT03445559|Behavioral|Academic Detailing|Academic detailing is an individual and facility-level intervention consistently shown to improve provider behavior. This strategy addresses the intervention functions of persuasion, coercion, modeling, and education which are effective methods for affecting behaviors driven by beliefs about capabilities, knowledge, social influences, beliefs about consequences, and environmental context and resources. During the meeting, the detailer will follow a script explaining that the visit is part of an experimental program to provide physicians with up-to-date, unbiased information about imaging to stage prostate cancer.
15926625|NCT03445559|Behavioral|Audit and Feedback|Audit and feedback is an effective, individual-level intervention for changing healthcare provider behavior, resulting in small but potentially clinically important benefits. Audit and feedback addresses the intervention functions of education, persuasion and incentivization, all of which are important for addressing beliefs about capabilities and consequences, knowledge, and social influence.
15926697|NCT03445013|Drug|SB414 6%|Twice daily
15926630|NCT03445520|Behavioral|Intervention Coaching Group|Parents in this group receive six, 1 hour, coaching sessions with a research staff coach, to discuss key information about transitions (knowing parent's rights about special education services, communicating effectively with school staff, knowing the roles of the school team members, how to develop and share your Snapshot, and what to do with your child over the summer to help with the transition). The coach will encourage the parent to identify a school staff member to help with preparing for the transition. If the post transition school team is not able to participate in a pre-transition meeting, then the coach will encourage the parent to share the Student Snapshot with the post-transition teacher(s) and school team when the new school year begins in the Fall.
15926631|NCT03445507|Other|Chat bot|Patients in intervention arm will use an evidence-based chat bot as an aid for smoking cessation
15926632|NCT03445507|Other|Usual care|Usual care given by their usual general practitioners and nurses of primary care health centres, as defined in Public Health System Portfolio.
15926633|NCT03445494|Procedure|Brace|A brace to be weared according to protocol
15926634|NCT03445494|Procedure|Normal sling|A normal sling to be weared according to protocol
15926635|NCT03445481|Device|Medacta femoral prosthesis|patients' treatment with a new implant prosthesis
15926636|NCT03445468|Biological|IL-YANG Quadrivalent Influenza Vaccine|A single 0.5mL dose administrated as an intramuscular injection.
15926637|NCT03445468|Biological|IL-YANG Flu Vaccine Pre-filled Syringe|A single 0.5mL dose administrated as an intramuscular injection.
15926638|NCT03445455|Device|Tidal volume measurement|"Recording of thoracic impendance variations during different non-invasive oxygenation techniques.
~Conversion to Tidal volume after calibration using the airway flow signal recorded during the NIV with bucco-nasal mask."
15926639|NCT03445442|Procedure|SCP|Sacrocolpopexy (SCP) aims to secure the anterior vaginal wall, the uterus more or less the posterior vaginal wall using polypropylene prostheses and to secure them to the presacral ligament to restore the patient's anatomical features and improve pelvic symptoms
15926640|NCT03445442|Procedure|NTR|Native tissue repair surgery (NTR) consist of site-specific surgical repair of the existing defect (anterior and/or posterior) using non-absorbable sutures. Specifically, anterior and/or posterior colporrhaphy for cystocele and rectocele respectively after adequate hydrodissection of the vesicovaginal or rectovaginal space.
15926641|NCT03445442|Procedure|VMR|Vaginal mesh repair surgery (VMR) is performed using a single-incision mesh system. A single vertical incision is made in the anterior and/or posterior vaginal wall. A full-thickness dissection is performed laterally and apically to the ischial spine.
15926642|NCT03445429|Other|3D-display system|The subjects will perform tasks on a minimal-invasive/laparoscopic training set-up. They will perform the tasks with a 3D-display system or a 4K-display system. The intervention type 3D-display system means that the training-set up is performed first with 3D-display system an after that with the 4K-display system.
15926643|NCT03445429|Other|4K-display system|The subjects will perform tasks on a minimal-invasive/laparoscopic training set-up. They will perform the tasks with a 3D-display system or a 4K-display system. The intervention type 4K-display system means that the training-set up is performed first with 4K-display system and after that with the 3D-display system.
15926644|NCT03445416|Behavioral|POL arm|A popular opinion leader intervention designed to increase routine vaccination among young black men who have sex with men.
15926645|NCT03445416|Behavioral|Comparison arm|A popular opinion leader intervention designed to increase routine vaccination among young black men who have sex with men.
15926646|NCT03445403|Other|Offset analgesia|Exposure to a moderate heat-pain stimulus applied for 5 seconds, raised by 1 degree C for 5 seconds, reduced by 1 degree C, and held for 20 seconds using a computerized paradigm in order to evoke endogenous pain modulation.
15926647|NCT03445390|Drug|Acetaminophen|Acetaminophen 1 g intravenous given at the beginning and end of surgery.
15926648|NCT03445390|Drug|Placebo|Placebo to match acetaminophen given at the beginning and end of surgery.
15926649|NCT03445377|Device|Real-time continuous glucose monitoring|Subjects randomised to Real-time continuous glucose monitoring will be given a Dexcom G5 or similar, training on its use, and HbA1c measurements taken at the start and end of the study. They will also be given validated questionnaires to complete.
15926650|NCT03445377|Device|Self-monitoring of blood glucose|Subjects randomised to self monitoring of blood glucose will be given a masked CGM which will be applied for one week, during Week 1, 4 and 8. HbA1c measurements will be taken at the start and end of the study. They will also be given validated questionnaires to complete.
15926651|NCT03445364|Other|Use of different injection pressure during primary PCI|Using ACIST injector during the PCI it is possible to change injection pressure - in one arm low pressure of 200psi, and in the second arm average pressure of 550psi
15926652|NCT03445351|Other|Aerobic, resistance and concorrent.|All protocols followed the American College of Sports Medicine (ACSM) guidelines , with frequency of three times per week, duration between 40-50 minutes, low to high intensity, modified according to the physical needs of each participant, respecting the physical training principles.
15926653|NCT03445338|Drug|K0706|Study
15926654|NCT03445338|Drug|K0706|Study
15926655|NCT03445338|Drug|K0706|Study
15926656|NCT03445325|Behavioral|LiGHT v2.1|"The LiGHT mobile program strives to support youth and their families to adopt lifelong healthy behaviours in four areas - eating, physical activity, recreational screen time and sleep - to foster healthy growth and development, to prevent chronic diseases and manage unhealthy weights.
~The program includes content that involve the family, and focus on behavioural therapy as well as dietary and physical activity patterns. LiGHT is intended to be engaging and fun, provide virtual and tangible rewards, and interact with participants multiple times per day. In addition, it will feature a mobile social support network and interaction with a live coach with specialized training in motivational interviewing to support youth/families in changing their health behaviours through messaging and phone calls."
15926657|NCT03445312|Behavioral|not processing urine cultures|microbiology lab will not process culture unless called
15926658|NCT03445299|Behavioral|Music|Listening to music for 30 minutes at bedtime
15926659|NCT03445286|Device|Silver Diamine Fluoride|Silver Diamine Fluoride (Advantage Arrest) for the experimental group
15926660|NCT03445286|Other|Normal Saline|Normal Saline for the control group
15926698|NCT03445013|Drug|Vehicle|Vehicle Comparator
15958662|NCT03198013|Drug|BMS-791826|Specified dose on specified days
15926661|NCT03445260|Other|Nutritional Supplements|PreCovery is a carbohydrate loading nutritional supplement, INergy FLD is an immunonutrition formulated liquid diet, and ISOlution is a protein supplement.
15926662|NCT03445260|Other|Placebo|Each placebo is composed of a collagen-based filler with exactly the same taste and texture as the intervention.
15926663|NCT03445247|Other|Extracorporeal low-intensity shockwave|Omnispec device to give a total of 1200 shockwaves, with low energy density at 0.1 mj/mm2 and a frequency of 120 shocks/min per kidney per treatment session, totally 12 times.
15926664|NCT03445234|Dietary Supplement|Blueberry|26 g/day freeze-dried powder, 2 weeks duration
15926665|NCT03445234|Dietary Supplement|Placebo|Placebo powder
15926666|NCT03445234|Dietary Supplement|banana|Acute ingestion of bananas 0.2 g carb/kg every 15 min exercise with water
15926667|NCT03445234|Dietary Supplement|No banana|water only
15926668|NCT03445221|Dietary Supplement|IV Immunonutrition|patients will receive preoperative immunonutrition in the form of glutamine) Dipeptiven-Fresenius Kabi) given by intravenous infusion 0.4g/kg/day for 5 days before surgery.
15926669|NCT03445221|Dietary Supplement|Conventional Diet|patients will continue preoperative oral conventional diet.
15926670|NCT03445208|Drug|BMS-986036|Crossover administration to abdomen then upper arm
15926671|NCT03445195|Drug|Sulbactam-ETX2514|The ETX2514SUL regimen of 1 g ETX2514/1 g sulbactam infused over 3 hours q6h.
15926672|NCT03445195|Drug|Placebo|Matching 1g IV solution.
15926673|NCT03445195|Drug|Imipenem-cilastatin|All patients will receive background therapy with 500 mg IV imipenem/cilastatin q6h.
15926674|NCT03445182|Procedure|Local anaesthesia with conventional syringe|"Buccal infiltration in posterior maxillary region with traditional technique. A 27 gauge short needle is inserted in the mucobuccal fold above the tooth to be anesthetized.
~Local anaesthetic infiltration speed 1ml/min. Drug: Local anaesthetic - Ubistesin - 4% Articaine with adrenaline 1: 200 000 1.7 mL"
15926675|NCT03445182|Device|Local anaesthesia with conventional syringe + Dentalvibe|"Buccal infiltration in posterior maxillary region. The tip of the DentalVibe device is placed in the mucobuccal fold above the tooth to be anesthetized. The device is activated for 5 s. A 27 gauge short needle is inserted as close as possible to the inner side of the prong while the vibration is still on.
~Local anaesthetic infiltration speed 1ml/min. After injection the needle is withdrawn and vibration continues for another 5 s.
~Drug: Local anaesthetic - Ubistesin - 4% Articaine with adrenaline 1: 200 000 1.7 mL"
15926676|NCT03445169|Drug|Belzutifan|Belzutifan Tablets
15926677|NCT03445156|Behavioral|Video game|Participants played either a violent shooting game or nonviolent shooting game in the pilot study, and either either a violent shooting game, nonviolent shooting game, or nonviolent non-shooting game in the experiment proper.
15926678|NCT03445156|Behavioral|Controller|Participants used either a gun-shaped or regular controller to play the violent and nonviolent shooting video games.
15926679|NCT03445130|Other|Lavandula Angustifolia oil (LO)|two drops on the inside of an oxygen face mask for 15 minutes.
15926680|NCT03445130|Other|Michelia Alba Leaf oil (MA)|two drops on the inside of an oxygen face mask for 15 minutes.
15926681|NCT03445130|Other|Almond oil (AO)|two drops on the inside of an oxygen face mask for 15 minutes.
15926682|NCT03445130|Other|Water|two drops on the inside of an oxygen face mask for 15 minutes.
15926683|NCT03445117|Other|Educational intervention|a) The educational intervention comprises putting up posters on vaccination in the clinic, as well as provision of a specially designed flyer to the clinic, which will be handed out by the clinic assistants to all patients 65 years and above, at the point of registration. The poster and flyer content will provide simple messaging to encourage patients to receive influenza and pneumococcal vaccinations and inform them of available healthcare subsidies. b) Reminders to physicians: The flyers will also serve as physical prompts to physicians to encourage vaccination for their patients. Doctors and clinic staff will also be updated on the study protocol and the recommended adult vaccination schedule before commencement of the study.
15926684|NCT03445104|Other|Huperzine A|During one of the two experimental sessions, participants will be given huperzine A.
15926685|NCT03445104|Other|Placebo|During one of the two experimental sessions, participants will be given a placebo.
15926686|NCT03445091|Device|SANKOM Patent Socks|Using compression socks to ease symptoms of patients with chronic venous insufficiency
15926687|NCT03445078|Dietary Supplement|selenium supplementation|administration of selenium-rich corn powder 20g/d offering selenium 100μg/d
15926688|NCT03445078|Dietary Supplement|ordinary corn powder|ordinary corn powder,20g/d(selenium contain <0.5ug/20g).
15926689|NCT03445065|Device|Eversense XL CGM System|The Eversense XL Continuous Glucose Monitoring (CGM) System consists of an implantable sensor inserted under the skin, an external transmitter, and a Mobile Medical Application (MMA) for display of glucose information that runs on a Handheld Device (HHD).
15926690|NCT03445065|Device|Usual SMBG or FGM device used by participants|Commercially available products in France for self-monitoring of blood glucose (SMBG) or flash glucose monitoring (FGM) were considered as comparators for this study.
15926691|NCT03445052|Behavioral|XPAND|The intervention is personalised to the psychosocial factors influencing poor photoprotection for each person. These factors could include beliefs that reduce motivation to protect as well as factors that prevent intentions being translated into action. The facilitator will use behaviour change techniques to target the factor most important for each person. Standardised content related to habit formation will be received. The intervention will be delivered via 7 1:1 sessions with a facilitator (psychologists or clinical nurse specialist). Sessions 1 (1.5 hours maximum) and 6 (45 minutes) will be delivered face to face in the home of the participant and the remaining sessions will be conducted via telephone calls or skype sessions.
15926692|NCT03445039|Device|traditional TSFE|The TSFE procedure is performed by osteotomes (Straumann AG, Basel, Switzland) and mallet as the traditional ways.
15926693|NCT03445039|Procedure|bone grafting materials|The bone substitute is placed into the siuns under the membrane before the implant placement
15926694|NCT03445039|Device|TSFE by DASK drills|The TSFE procedure is performed by DASK(Dentium Advanced Surgical Kits) drills (Dentium, Korea), the residual cortical plate of the sinus floor is grinded by the drills.
15926695|NCT03445039|Procedure|without bone grafting materials|The bone substitute will not be placed into the sinus before the implant placement.
15926696|NCT03445026|Diagnostic Test|dental panorama|radiographic examination
15926699|NCT03445000|Drug|Alectinib|"Alectinib is administered orally 600mg (4x150mg capsules), twice per day (8 capsules, total 1200mg daily). The appropriate number of alectinib capsules will be provided to patients to be self-administered at home.
~Alectinib capsules must be taken at the same time each day with food. If a planned dose of alectinib is missed, patients can take the missed dose up until 6 hours before the next dose."
15926700|NCT03444987|Genetic|Measurement of protein expression in tissues.|"The followings markers will be estimated in tissue
~FAP, a marker of fibroblast activation, using quantitative real time polymerase chain reaction qRTPCR (mRNA level) and ELISA (protein level).
~Markers of autophagy including LC3 and p62 using qRTPCR (mRNA level) and by immunohistochemical analysis.
~Phosphorylated protein kinase B (pAKT) level by ELISA (protein level).
~Markers of oxidative stress (Malondialdehyde as lipid peroxide) by a colorimetric method.
~Reduced glutathione, an antioxidant marker by a colorimetric method"
15926701|NCT03444974|Other|adapted treatment according to the MATRIX-A therapy|cognitive and behavioral treatment of drug abuse/dependency issues, as well as connected parameters
15926702|NCT03444961|Device|CAREN system training|CAREN allows Argus users to be trained and enhance their device usage in a safe, controlled, and standardized environment.
15926703|NCT03444948|Device|EUS-RFA using Habib Tm as a probe|3 EUS-RFA interventions at 1-month interval
15926704|NCT03444948|Procedure|EUS|Standard intervention
15926705|NCT03444935|Behavioral|Follow-up phone call|Please see arm/group description.
15926706|NCT03444922|Other|Placebo|Ingestion of Placebo
15926707|NCT03444922|Other|BPA 4 ug/kg BW|Oral BPA ingestion of 4 ug/kg BW
15926708|NCT03444922|Other|BPA 50 ug/kg BW|Oral BPA ingestion of 50 ug/kg BW
15926709|NCT03444909|Device|cardiotocograph|Monitoring of 20 min with the cardiotocograph
15926710|NCT03444909|Device|Toconaute|Monitoring of 20 min withToconaute
15926711|NCT03444909|Device|electrophysiological device (Micromed)|Monitoring of 20 min with the cardiotocograph
15926712|NCT03444896|Device|Acupuncture group|Acupuncture needles were placed at acupoints Baihui (DU20), Shenting (DU24), Fengfu (DU16), Fengchi (GB20), Danzhong (RN17), Zhongwan (RN12), Qihai (RN6), Neiguan (PC6), Zusanli (ST36), Xuehai (SP10), Xinshu (BL15), Yixi (BL45), Tongli (HT5), and Zhaohai(KI6). Electrodes were attached the needle holders of the Baihui (DU20) and Shenting (DU24). The acupuncture needles are inserted through the adhesive pads and are retained for 20 minutes in every course. Treatment will be conducted over a period of 3 months, at a frequency of two times per week.
15926713|NCT03444896|Device|Sham acupuncture group|Sham acupoint (SA) 1 located in the midpoint of Shuaigu and Touwei. SA2 located in the midpoint of Touwei and Yangbai. SA3 located in the midpoint of Tianyou and Tianrong. SA4 located in 4 cun above umbilicus and 1 cun right of umbilical midline (UM). SA5 located in 2 cun below umbilicus and 1 cun right of UM. SA6 1 cun outside the point 1/4 of the line between Shenmen and Shaohai. SA7 located in 1 cun outside the midpoint of Shaohai and Tongli. SA8 located in 6 cun above mediosuperior border of the patella. SA9 located in 3 cun below the Yanglingquan and middle of the gallbladder and bladder channels. SA10 located in midpoint between Jiexi and Qiuxu. SA11 and SA12 located in 2 cun from the lower border of spinous process of fifth or sixth thoracic vertebra. Electrodes were attached the needle holders of the bilateral SA 2. Procedures, and other treatment settings were the same in the acupuncture group but with no skin penetration, electricity output, or needle manipulation for de qi.
15926714|NCT03444883|Drug|Ilaprazole|10mgx2 tablet once daily for weeks
15926715|NCT03444870|Drug|Gantenerumab|Gantenerumab will be administered as per the schedule specified in the respective arm.
15926716|NCT03444870|Drug|Placebo|Placebo will be administered as per the schedule specified in the respective arm.
15926717|NCT03444857|Device|Continuous positive airway pressure|The optimal continuous positive airway pressure (CPAP, AutoSet S9, ResMed, Sydney, Australia) settings will be determined during 1-2 nights within 7 days after pPCI.
15926718|NCT03444844|Drug|Ga-68 P16-093 PET/CT scan|IV injection followed by PET/CT scanning
15926719|NCT03444831|Drug|Buspirone|Buspirone 5mg used QID a day after meal plus 20mg omeprazole before breakfast.
15926720|NCT03444831|Drug|Placebo Oral Tablet|Buspirone placebo QID after meal plus 20mg omeprazole before breakfast.
15926721|NCT03444818|Drug|[14C]-E6007|Oral administration
15926722|NCT03444805|Procedure|Autologous HSCT|1st AHSCT
15926723|NCT03444792|Procedure|mechanical dilatation of the cervix|"the surgeon will perform the cervical dilatation by inserting the double-gloved index ﬁnger into the cervical canal of the patients after the extraction of placenta and membranes. The outer glove will be removed after this procedure.
~- If failed the surgeon will use artery forceps to dilate cervix"
15926724|NCT03444779|Device|Tibial Tuberoplasty|Kyphoplasty ballon
15926725|NCT03444779|Device|Open technique|Cutaneous incision with submeniscal arthrotomy under guidance of a fluoroscope.
15926726|NCT03444766|Drug|Nivolumab|specified dose on specified days
15926727|NCT03444753|Drug|BMS-986299|Specified dose on specified day
15926728|NCT03444753|Biological|Nivolumab|Specified dose on specified day
15926729|NCT03444753|Biological|Ipilimumab|Specified dose on specified day
15926730|NCT03444740|Other|ICIQ-FLUTS, ADMN-20|Questionnaire
15926731|NCT03444727|Other|Ice Pre-treatment|Topical application of ice prior to local anesthetic injection.
15926732|NCT03444727|Other|Room Temperature Water Pre-treatment|Topical application of room-temperature water prior to local anesthetic injection.
15926733|NCT03444714|Drug|RiMO-301|"Drug: RiMO-301 RiMO-301 will be administered by intratumoral route as slow injection
~Radiotherapy Patients will receive 10 fractions of 3 Gy each over 2 weeks"
15926736|NCT03444688|Other|Conventional Gait Training|Subjects allocated to the CT group will first perform active assisted or passive range of motion of the lower limbs including ankle, knee, and hip joint in the supine position for 10 minutes. They will then perform conventional gait and balance therapy based on the proprioceptive neuromuscular facilitation (PNF) concept for 15 minutes. They will be given a 5 minutes rest. Finally, the CT subjects will undergo the over-ground gait training with or without aid or orthoses and with manual assistance from senior physiotherapist for 15 minutes, depending on the individual subject's abilities.
15958663|NCT03198013|Drug|Placebo|Specified dose on specified days
15926737|NCT03444688|Device|Gait rehabilitation with walker|For WT group, subjects will first go through active assisted or passive range of motion of the lower limbs including ankle, knee, and hip joint in the supine position for 10 minutes. The main therapy consists of 2 parts with 5 minutes rest in between. During part 1, subjects will be trained on the robotic walker with the help of active body weight support (BWS) and functional electrical stimulation (FES) for 15 minutes with pelvic motion support function and lateral balance function being continuously provided. During part 2, subjects will also receive resistance/assistance forces on top of the BWS and FES training for 15 minutes.
15926738|NCT03444662|Dietary Supplement|Placebo supplement|Cellulose and Sunflower oil
15926739|NCT03444662|Dietary Supplement|Citicoline and Omega-3 supplement|Citicoline and Omega-3
15926740|NCT03444662|Dietary Supplement|Omega-3 supplement|Cellulose and Omega-3
15926741|NCT03444649|Drug|Epacadostat|Epacadostat orally two times daily (BID) for two cycles (28 days each) in combination with standard induction chemotherapy (Idarubicin and Cytarabine)
15926742|NCT03444649|Drug|Idarubicin|Standard chemotherapy d1-d3 cycle 1
15926743|NCT03444649|Drug|Cytarabine|Standard chemotherapy d1-d7 cycle 1 and 2
15926744|NCT03444649|Drug|Daunorubicin|Standard chemotherapy d1-3 cycle 2
15926745|NCT03444636|Drug|Ropivacaine/Fentanyl|Ropivacaine 0.2% with Fentanyl 5 µg/ml; flow rate of 0.1 ml/kg/hr
15926746|NCT03444636|Drug|Bupivacaine/Fentanyl|Bupivacaine 0.125% with Fentanyl 5 µg/ml; flow rate of 0.1 ml/kg/hr
15926747|NCT03444610|Biological|Blood transfusion escalation rate|3+3 dose escalation (3 patients/cohort) each started on a fixed rate (standard is 5 ml/kg/ hr).1st cohort start at 6ml/kg/hr till complete prescribed volume. Rate escalation by 1ml/kg/each cohort until dose limiting toxicities (DLTs) or max of 10ml/kg/hr. If no DLTs new cohort enrolled at the next planned rate. If DLTs seen in 1 patient in the cohort, another 3 patients treated with the same dose level.1ry phase I end point is maximum-tolerated rate (MTR) of blood transfusion that can be infused safely ( max rate at which 1 or fewer of 3 patients experienced DLT) or dose of 10ml/kg/hr. DLT is transfusion related adverse event lead to stop of transfusion. MTR is highest dose at which no more than 1of 6 patients experienced a DLT.15 additional patients enrolled at MTR to confirm safety.
15926748|NCT03444584|Drug|MEDI0382|Subcutaneous dose of MEDI0382 (titrated up from 100 μg for 7 days to 200 μg for 7 days and to 300 μg for 14 days).
15926749|NCT03444584|Drug|Placebo|Subcutaneous dose of placebo matched to MEDI0382.
15926750|NCT03444584|Drug|Dapaglifozin|Oral dose of dapaglifozin 10 mg tablet.
15926751|NCT03444584|Drug|Metformin|Oral dose of metformin tablet (maximum tolerated dose [MTD] > 1 g).
15926752|NCT03444571|Procedure|revision surgery|If DNA based diagnosis detects infection, standard revision surgery will be conducted
15926753|NCT03444558|Dietary Supplement|Natural supplement containing chlorogenic acid and luteolin|50 eligible subjects will receive natural supplement as the oral pills at a fixed dose of 1 pill/day (450 mg/day) for 6 months, as add-on therapy to the ongoing treatment, maintained at fixed doses for the entire study.
15926754|NCT03444558|Other|Placebo (without any active ingredients)|50 eligible subjects will receive placebo (without any active ingredients) at a fixed dose of 1 pill/day for 6 months, as add-on therapy to the ongoing treatment, maintained at fixed doses for the entire study.
15926755|NCT03444545|Device|Capnodynamic method|"Expired carbon dioxide is measured with a mainstream infrared sensor (Capnostat-3, Respironics Inc, Wallingford, CT, USA) and gas flow analysed with the flow sensor incorporated in the ventilator (Servo-i, Maquet Critical Care, Solna, Sweden) which was connected to a computer where all the mathematical analysis is carried out with a software written in Matlab™ (The Mathworks Inc, Natick, MA, USA).
~Instead of a fixed ratio between inspiration and expiration, three breaths out of every nine are prolonged with a 3-4 seconds longer expiration creating small changes in end- expiratory CO2"
15926756|NCT03444545|Device|Transpulmonary thermodilution|Each cardiac output measurement comprises an average of three thermodilutions performed successively one after another. TPTD is performed with a PiCCO2 monitor (Pulsion Medical Systems SE, Feldkirchen, Germany)
15926757|NCT03444532|Behavioral|12-week aerobic exercise and cognitive-behavioral therapy|12-week intervention of aerobic exercise training and four session of cognitive-behavioral therapy
15926758|NCT03444519|Drug|Mannitol|This drug is in our routine use of neuroanesthesia, are given for facilitate brain relaxation
15926759|NCT03444506|Drug|Molo 1 (also referred as GSP 301-2 NS)|
15926760|NCT03444506|Drug|Molo 2 (also referred as GSP 301-1 NS)|
15926761|NCT03444506|Drug|Placebo nasal spray|
15926762|NCT03444506|Drug|DYMISTA nasal spray|
15926763|NCT03444506|Drug|PATANASE nasal spray|
15926764|NCT03444493|Other|Exercise|Exercises were basically performed in 3 phases in this study. In the first phase; effectively and correctly contraction of TrA and multifidus muscles and how the patients adapted to daily life activities was taught. In the second phase; was aimed that the protection of stabilization by counteracting more muscle activation, in the third phase neutral position along with the activities required high level control.
15926765|NCT03444480|Drug|Remimazolam Tosylate|Initial dose plus supplemental doses
15926766|NCT03444467|Drug|NNC9204-1513|"Participants will receive NNC9204-1513 subcutaneous (s.c., in to a skin fold on the stomach) injection as single increasing doses of 0.01 mg, 0.04 mg, 0.10 mg, 0.25 mg, 0.50 mg, 1.0 mg or 2.0 mg. Each participant will only be given one dose.
~Dose escalation will proceed to the next planned dose level if there are no safety concerns raised by the investigator or by the trial safety group."
15926767|NCT03444467|Drug|Glucagon|Participants will receive single dose of 1 mg glucagon s.c. injection.
15926768|NCT03444467|Drug|Placebo|Participants will receive single dose of placebo (for double dummy injections).
15926769|NCT03444454|Behavioral|VRRS Khymeia|"Participants will receive an individualized exercise program set up by the therapist. The intervention applied to the experimental group will consist of 30 sessions of Khymeia VRRS training distributed in five sessions for week, each lasting 45 minutes.
~Each session is constructed by alternating physical with cognitive activities. The sessions will initially be tailored to the patient's baseline characteristics. Remotely, the therapist will then adjust the participant's exercise program as appropriate, by changing exercises, level of difficulty or number of repetitions."
15926770|NCT03444454|Behavioral|Usual care program|The usual care group will have written, home-based exercise program, provided to them at an initial face-to-face assessment.
15960800|NCT03182426|Drug|Alemtuzumab|T-cell depletion
15926771|NCT03444454|Behavioral|VRRS Khymeia plus active tDCS|"Participants will receive 5 sessions each lasting 45 minutes of an individualized home-based VRRS training combined with active (anodal) tDCS applied to the left dorsolateral prefrontal cortex over 1 week, followed by 5 weeks of home-based VRRS training.
~The sessions of VRRS will initially be tailored to the patient's baseline characteristics. Remotely, the therapist will then adjust the participant's exercise program as appropriate, by changing exercises, level of difficulty or number of repetitions."
15926772|NCT03444454|Behavioral|VRRS Khymeia plus placebo tDCS|"Participants will receive 5 sessions each lasting 45 minutes of an individualized home-based VRRS training combined with active (anodal) tDCS applied to the left dorsolateral prefrontal cortex over 1 week, followed by 5 weeks of home-based VRRS training.
~The sessions of VRRS will initially be tailored to the patient's baseline characteristics. Remotely, the therapist will then adjust the participant's exercise program as appropriate, by changing exercises, level of difficulty or number of repetitions."
15926773|NCT03444441|Procedure|Foot or ankle surgery|Surgery for foot or ankle
15926774|NCT03444428|Other|Non Invasive Ventilation|Assessments for those participants who are being set up onto NIV
15926775|NCT03444428|Other|Without Non Invasive Ventilation|Assessments for those participants who are not being set up onto NIV
15926776|NCT03444415|Other|Motivational interviewing in groups|Intervention consists of six 90 minutes workshops, two of those during pregnancy and the other four within the following two years after the birth of the children.
15926777|NCT03444415|Other|Usual care|Parents will receive information about height, weight, and BMI percentile provided by a health professional during usual well child visits
15926778|NCT03444402|Drug|CKD-381(formulation I)|1 tablet administered before the breakfast during 7 days
15926779|NCT03444402|Drug|CKD-381(formulation II)|1 tablet administered before the breakfast during 7 days
15926780|NCT03444402|Drug|D026(Nexium 40mg)|1 tablet administered before the breakfast during 7 days
15926781|NCT03444376|Drug|GX-188E|GX-188E (1.0mg/0.5ml/vial), Intramuscular administration using electroporator, Ichor TDS-IM device
15926782|NCT03444376|Drug|Keytruda|pembrolizumab(100mg/4mL/vial), Intravenous administration
15926783|NCT03444363|Device|Laser group|Laser application in addition to SRP
15926784|NCT03444363|Device|Control group|Placebo laser application in addition to SRP
15926785|NCT03444350|Device|Gaseous ozone|SRP plus gaseous ozone
15926786|NCT03444350|Device|SRP plus placebo|only SRP
15926787|NCT03444337|Device|Catheter Ablation|
15926788|NCT03444324|Biological|BT524|BT524 is administered intravenously, patient specific dosage calculated based on body weight and fibrinogen level.
15926789|NCT03444324|Biological|FFP|FFP is administered intravenously; dosage according to local standards in mL per kg body weight.
15926790|NCT03444311|Dietary Supplement|A: 1 dosis|"1 dosis (3E+09 cfu/d + 6 g of fiber) Two different combinations of fibers (formula A and B) will be tested with the following administration pattern for both groups.
~Week 1: Formula A Week 2: Formula A Week 3: Formula B Week 4: Formula B
~Composition of an envelope of formula A:
~Formula A Composition (g) Pectin 1 B-glucan oatmeal 0.25 High-grade polymerization inulin 1.75 Inulin of low degree of polymerization 1,5 Polydextrose 1 Guar gum partially hydrolyzed 0,5 TOTAL 6
~Composition of an envelope of formula B:
~Formula B Composition (g) Pectin 1 B-glucan oatmeal 0.25 High-grade polymerization inulin 1 Inulin of low degree of polymerization 0.75 Polydextrose 2.5 Guar gum partially hydrolyzed 0,5 TOTAL 6"
15926791|NCT03444311|Dietary Supplement|B: 2 dosis|"1 dosis (3E+09 cfu/d + 12 g of fiber) Two different combinations of fibers (formula A and B) will be tested with the following administration pattern for both groups.
~Week 1: Formula A Week 2: Formula A Week 3: Formula B Week 4: Formula B
~Composition of an envelope of formula A:
~Formula A Composition (g) Pectin 1 B-glucan oatmeal 0.25 High-grade polymerization inulin 1.75 Inulin of low degree of polymerization 1,5 Polydextrose 1 Guar gum partially hydrolyzed 0,5 TOTAL 6
~Composition of an envelope of formula B:
~Formula B Composition (g) Pectin 1 B-glucan oatmeal 0.25 High-grade polymerization inulin 1 Inulin of low degree of polymerization 0.75 Polydextrose 2.5 Guar gum partially hydrolyzed 0,5 TOTAL 6"
15926792|NCT03444298|Drug|Gamma Tocopherol|Each dose consists of two (700 mg) capsules by mouth once daily for a total of 7 days.
15926793|NCT03444298|Drug|Placebo|Each dose consists of two (700 mg) capsules by mouth once daily for a total of 7 days.
15926794|NCT03444285|Other|Warm Up|Run on a treadmill during 10 minutes without fatigue of the participant after this time.
15926795|NCT03444285|Other|Hot Pack|20 minutes of hot-pack on both hamstring
15926796|NCT03444272|Drug|Sofosbuvir and Daklatasuvir|HCV Treatment (Sofosbuvir and Daklatasuvir)
15926797|NCT03444259|Procedure|Cardiac surgery|Open heart surgery
15926798|NCT03444246|Dietary Supplement|Iodine free diet group|120 patients with hyperthyroidism relapsed after new diagnosis or treatment were enrolled. They were randomly divided into iodine free diet group and normal iodine diet group. The two groups were treated with routine antithyroid drugs, followed up for 6 months.
15926799|NCT03444246|Dietary Supplement|Normal iodine diet group|120 patients with hyperthyroidism relapsed after new diagnosis or treatment were enrolled. They were randomly divided into iodine free diet group and normal iodine diet group. The two groups were treated with routine antithyroid drugs, followed up for 6 months.
15926800|NCT03444233|Other|Diet|7 days fruit-rich diet, 7 days HFCS-rich diet
15926801|NCT03444220|Biological|Anaerobically Cultivated Human Intestinal Microbiota|30ml ACHIM will be administrated at week 0 and 2 with 14 days apart
15926802|NCT03444220|Biological|Anaerobically Cultivated medium|30ml medium will be administrated at week 0 and 2 with 14 days apart
15926803|NCT03444207|Behavioral|Endurance training|The women in group A underwent endurance exercise on cycle ergometers (Schwinn Evolution, Schwinn Bicycle Company, Boulder, Colorado, USA). Exercise sessions consisted of a five-minute warm-up (stretching exercise) at low intensity (50%-60% of maximum heart rate), a 45-minute exercise (at 50%-80% of maximum heart rate), five minutes of cycling without a load, and five minutes of closing stretching and breathing exercise of low intensity.
15926831|NCT03443986|Other|Resistance training associated with vibration|The workout will be held three times a week and will last a total of 12 weeks (3 months) for 45 minutes, where there will be 5 minutes of heating, 19 minutes of exercise with load, 16 minutes of vibration and 5 minutes of slowdown.
15926896|NCT03443518|Procedure|Psoas Compartment Block (PCB)|30 ml of bupivacaine 0.25% will be infused over 3 minutes at the anatomical landmark for Psoas Compartment Block (PCB)
15926804|NCT03444207|Behavioral|Endurance-strength training|Group B performed endurance-strength exercise consisting of a five-minute warm-up (stretching exercises) of low intensity (50%-60% of maximum heart rate), a strength component, an endurance component, 5 minutes cycling without a load, and a 5 minutes closing stretching and breathing exercise of low intensity. The 20-minute-long strength component was performed using a neck barbell and a gymnastic ball. Directly after the strength exercise, the women took part in a 25-minute endurance exercise on cycle ergometers (Schwinn Evolution, Schwinn Bicycle Company, Boulder, Colorado, USA) at 50%-80% of maximum heart rate.
15926805|NCT03444194|Procedure|liver biopsy|Liver biopsy of neoplastic tissue and normal liver tissue.
15926806|NCT03444181|Behavioral|Music lessons|Also described as neurocognitive music therapy. Singing lessons will be provided once a week for a period of 12 months by a person with a qualification in music therapy, or by a person with a different relevant qualification (e.g. psychology and music teaching) under the supervision of a music therapist. Additionally, participants will have the opportunity to meet regularly (1-2 times per month) as a choir to sing the song they have learned together in a group.
15926807|NCT03444181|Behavioral|Training intervention|Cognitive training that is comparable in scope and extent to the music lessons, but not using music. Group training sessions will be provided once a week for a period of 12 months by a person with a qualification in physiotherapy or occupational therapy. Group activities may include group tours such as mountain hikes and the like (about 2 times per month) and will follow an established program for the elderly.
15926808|NCT03444155|Dietary Supplement|Natural Panmol-B-Complex|Natural Panmol-B-Complex: B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg) - Synthetic Vitamin B-Complex - B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg)
15926809|NCT03444155|Dietary Supplement|Synthetic Vitamin B-Complex|Synthetic Vitamin B-Complex: B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85µg) - Natural Panmol-B-Complex: B1 (2.93 mg), B2 (3.98 mg), B3 (29.85 mg), B5 (10.95 mg), B6 (3.38 mg), B7 (0.108 mg), B9 (0.69 mg), B12 (8.85 µg)
15926810|NCT03444142|Drug|Exenatide LAR|2 mg, once weekly subcutaneously before breakfast during 4 weeks.
15926811|NCT03444142|Drug|Dulaglutide|.75 mg once weekly subcutaneously before breakfast during 4 weeks.
15926812|NCT03444129|Behavioral|Healthy eating workshop and interactive health game|The intervention sessions will be weekly for 6 weeks and will involve participation in health education workshop and interactive health game. Sessions may last up to 2 hours and will be held at designated times/days at a Chicago Church.
15926813|NCT03444129|Behavioral|Healthy eating workshop|The intervention sessions will be weekly for 6 weeks and will involve participation in health education workshop. Sessions may last up to 2 hours and will be held at designated times/days at a Chicago Church.
15926814|NCT03444116|Diagnostic Test|Motion Analysis|Gait and Motion Analysis, comprised of 3-dimensional kinematics and kinetics, electromyography, energy expenditure, and physical exam (range of motion, strength, spasticity, etc.)
15926815|NCT03444116|Diagnostic Test|sterEOS Imaging of Lower Extremities|Bi-planar imaging of the lower extremities to evaluate femoral anteversion and hip dysplasia and subluxation.
15926816|NCT03444116|Behavioral|Surveys|9 surveys assessing function, activity, participation, pain, quality of life, and treatment history.
15926817|NCT03444103|Drug|Clazakizumab / Clazakizumab|Humanized monoclonal anti-IL-6 antibody
15926818|NCT03444103|Drug|Placebo / Clazakizumab|0.9% Saline
15926819|NCT03444090|Procedure|Colon polypectomy|"For participants assigned into the experimental group, colon lumen is washed and the debris is suctioned as the colonoscopy is slowly inserted from rectum to cecum. Deliberate and systematic inspection of the mucosa is performed with adequate insufflation during both the insertion and withdrawal phases. Colon polyps with size <10 mm are removed as they are identified on insertion and withdrawal. Polyps with size >10 mm are removed only during withdrawal.
~For participants assigned into the control group, deliberate inspection and polyp removal are performed exclusively on colonoscopy withdrawal.During insertion, minimal mucosal inspection and insufflation are applied to efficiently advance the instrument into cecum."
15926820|NCT03444077|Diagnostic Test|Use of the Trauma Induced Coagulopathy Clinical Score (TICCS) as a diagnostic tool.|The TICCS will be calculated on the site of injury for the patients taken in charge in the intervention group. Those patients will be classified in two categories regarding their TICCS value. Patients with TICCS ≥ 10 will be classified as in need for DCR; while patients with TICCS < 10 will be classified as not in need for DCR.
15926821|NCT03444077|Diagnostic Test|Regular care|Patients from the control group will be evaluated by clinicians using the local usual clinical Tools.
15926822|NCT03444077|Other|STTTOPPP the bleeding|"Surgical team pre-activation
~Trauma team pre-activation
~Transfusion team pre-activation
~Tranexamic acid (administration of 1 gram of TXA if documented hyperfibrinolysis)
~O negative RBC transfusion as soon as possible
~Plasma and Platelets transfusion as soon as possible
~Permissive hypotension (restrictive use of crystalloids: no more than 500 milliliters before definitive control of the bleeding is achieved)
~Prophylaxis (initiate antithrombotic prophylaxis as soon as the bleeding is under control and coagulation tests are normal, first evaluation before the 24th hour after trauma)"
15926823|NCT03444077|Other|Regular Care|Regular local pre-hospital care.
15926824|NCT03444064|Biological|PolyTregs|Treatment group receive PolyTregs 6 weeks after islet transplantation as immunotherapy to improve islet survival and reduce the need for immunosuppression drugs.
15926825|NCT03444051|Procedure|EUS-FNB with 20-gauge Procore® needle|Puncture of a pancreatic or peripancreatic mass under Endoscopic Ultrasonography, with a 20-gauge Procore® needle
15926826|NCT03444051|Procedure|EUS-FNB with 22-gauge Acquire® needle|Puncture of a pancreatic or peripancreatic mass under Endoscopic Ultrasonography, with a 22-gauge Acquire®
15926827|NCT03444038|Drug|NBI-98854|vesicular monoamine transporter 2 (VMAT2) inhibitor
15926828|NCT03444025|Drug|Goserelin|Goserelin is Luteinizing hormone releasing hormone (LHRH) analogue.
15926829|NCT03444012|Drug|ticagrelor 90 mg|persistence and adherence on ticagrelor in ACS patients
15926830|NCT03443999|Device|Supraflex Family Sirolimus-eluting Coronary Stent System|Patient implanted with at least one Supraflex Family sirolimus-eluting stent as a part of planned clinical care
15926897|NCT03443518|Procedure|Local Anesthesia infiltration|Lidocaine 5 ml of 2% will be injected subcutaneous as local infiltration.
15960801|NCT03182426|Drug|Anakinra|Anti-inflammatory
15926832|NCT03443986|Other|Resistance training associated with vibration sham|"he workout will be held three times a week and will last a total of 12 weeks (3 months) for 45 minutes, where there will be 5 minutes of heating, 19 minutes of exercise with load, 16 minutes of vibration sham and 5 minutes of slowdown."
15926833|NCT03443973|Drug|Gantenerumab|Gantenerumab will be administered as per the schedule specified in the respective arm.
15926834|NCT03443973|Drug|Placebo|Placebo matching to gantenerumab will be administered as per the schedule specified in the respective arm.
15926835|NCT03443960|Drug|TNX-102 SL 5.6 mg|Subjects randomly assigned to this treatment will place 2 tablets simultaneously under the tongue until dissolved, and not to crush or chew them.
15926836|NCT03443960|Drug|Amrix 30 mg|Subjects randomly assigned to this treatment will swallow 1 capsules with a cup of water, and not to crush or chew it.
15926837|NCT03443947|Device|Tongue depressor group|using a tongue depressor to assess airway score without tongue protrusion
15926838|NCT03443947|Procedure|control group|airway assessment after tongue protrusion
15926839|NCT03443921|Procedure|Artery Divestment Technique|Tunica adventitia was pick up by forceps and opened by electrocoagulation at 1 cm distal from tumor-artery contact. Space between tunica adventitia and external elastic lamina (EEL) were blunt lifting tumor-invaded adventitia by angled clamp. Adventitia was then sectioned to show EEL. Loose dissect space could be achieve along long the plane between EEL and adventitia as long as tumor invasion outside EEL. Tumor and invaded adventitia were further cut open by electrocoagulation proximally. Circumferentially, separation could be done by blunt dissection around EEL. Nourishing blood vessels of the artery would be secured by electrocoagulation or ultrasonic scalpel while major branch would be ligated or transfixed.
15926840|NCT03443921|Drug|Nab-paclitaxel|After eligibility testing as blood tests, contrast-enhanced CT and MRI scan, 3 cycles were administered (1,000 mg/m2 of gemcitabine and 125 mg/m2 of nab-paclitaxel on days 1, 8, and 15 every 28 days).Patients will be reevaluated and curative operation would be attempted if without disease progression.
15926841|NCT03443908|Device|CPAP|CPAP therapy 3-4 weeks
15926842|NCT03443895|Drug|AEF0117 oral capsule|0.6, 2 and 6mg of AEF0117
15926843|NCT03443895|Drug|Placebo oral capsule|Matching placebo capsule
15926844|NCT03443882|Dietary Supplement|Astaxanthin|an oral dose form
15926845|NCT03443869|Drug|Letermovir|LET 480mg (or 240 mg when co-administered with cyclosporin A) once daily for 28 weeks
15926846|NCT03443869|Drug|Valganciclovir|900 mg VGCV tablet orally, once daily for 28 weeks
15926847|NCT03443869|Drug|Acyclovir (ACV)|400 mg over-encapsulated ACV tablet orally, every 12 hours for 28 weeks
15926848|NCT03443869|Drug|Placebo to ACV|Over-encapsulated placebo tablet orally, every 12 hours for 28 weeks
15926849|NCT03443869|Drug|Placebo to LET|Placebo to LET tablet orally, once daily for 28 weeks
15926850|NCT03443869|Drug|Placebo to VGCV|Placebo to VGCV tablet orally, once daily for 28 weeks
15926851|NCT03443856|Drug|Nivolumab and Ipilimumab|Nivolumab 1 mg/kg IV Q3W plus Ipilimumab 3 mg/kg IV Q3W for 4 cycles (3 months) followed by nivolumab 240 mg flat-dose IV Q2W for 9 months.Total treatment time 1 year
15926852|NCT03443856|Other|chemotherapy|Completion of the perioperative treatment according to the 2016 ESMO guidelines (change of regimen is not allowed).
15926853|NCT03443843|Drug|loratadine + pseudoephedrine sulfate (BAY818725/Claritin-D)|Single dose of Loratadine/pseudoephedrine in tablet 5 mg/120 mg orally
15926854|NCT03443843|Drug|Placebo tablet|Placebo tablet orally
15926855|NCT03443843|Drug|Fluticasone Propionate|Fluticasone Propionate Nasal Spray 50mcg per spray, 2 sprays per nostril
15926856|NCT03443843|Drug|Placebo spray|Placebo Nasal Spray, 2 sprays per nostril
15926857|NCT03443830|Drug|Tyzivumab|Tyzivumab Injection, (100 mg/5 mL/Vial), Zika Virus (ZIKV) Monoclonal Antibody (mAb) Infused over 30 minutes
15926858|NCT03443817|Behavioral|Tele rehab|"Video Consultation (VC) Sessions: Each patient will have the opportunity to have minimum one VC per week the first month, one VC each second week the second month one VC a month
~Retraining breath: Patients will also be instructed to use different techniques to breath during the video consultations with the physiotherapist.
~Chat Sessions: Each patient has the opportunity to chat with the physiotherapist any time via the chat module of the system.
~Workout Sessions with a Virtual Physiotherapist Agent (VPA): The patient will train according to what is decided by the physiotherapist and the patient in the VC or chat meetings. Normally, the patients will train 10-20 minutes daily at home with its individual and tailored VPA.
~Patients' security: In order to minimize the risks of possible accidents while performing the exercises, the patient will answer questions before and after each exercise performance that the physiotherapist can follow in real time."
15926859|NCT03443804|Drug|Test(DW1401)|DW1401+Placebo of Stillen tab.
15926860|NCT03443804|Drug|Reference(Stillen tab.)|Stillen tab.+Placebo of DW1401
15926861|NCT03443791|Diagnostic Test|Women Enrolled|Diagnostic Testing will be performed. Results of individual test results will determine the degree of intervention offered.
15926862|NCT03443791|Diagnostic Test|Newborns of Female Study Participants|Newborns will be tested after birth as soon as possible for CMV positivity.
15926863|NCT03443778|Drug|Bupivacaine 0.5%|Marcaine 0.5% Injectable Solution
15926864|NCT03443778|Drug|Bupivacaine 0.5% , Dexamethasone|Bupivacaine 0.5% , Dexamethasone
15926865|NCT03443778|Drug|Nacl 0,9 %|Injectable Solution
15926866|NCT03443765|Diagnostic Test|Detection of Plasma levels of 25(OH) vitamin D by ELISA technique|Five milliliters of peripheral venous blood sample will be taken (after 8-12 hours of fasting) from each participant and will be collected into HumaTube Serum Gel - C/A for ELISA. Serum will be appropriately obtained and stored at -20°C maximum of 30 days. Plasma levels of 25(OH) vitamin D will be detected by enzyme-linked immunosorbent assay (ELISA) technique.
15926867|NCT03443765|Diagnostic Test|Detection of Total serum immunoglobulin E by ELISA technique|Five milliliters of peripheral venous blood sample will be taken (after 8-12 hours of fasting) from each participant and will be collected into HumaTube Serum Gel - C/A for ELISA. Serum will be appropriately obtained and stored at -20°C maximum of 30 days. Total serum immunoglobulin E will be detected by enzyme-linked immunosorbent assay (ELISA) technique.
15926895|NCT03443531|Drug|Placebo Yifei Qinghua granule|According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of Qi and Yin deficiency of the lung and the phlegm-heat obstructing the lung will be given placebo Yifei Qinghua granule, twice daily for 24 weeks for lower dosage.
15926868|NCT03443752|Other|Shotokan-Karate|The Shotokan-Karate training program will be ran over a period of 12 weeks. Classes will be conducted 3 times per week at the Movement Disorders Rehabilitation Centre in Waterloo, Ontario. The program will be conducted by a trained professional (principal investigator), and there will be volunteers who ensure the safety and well-being of participants.
15926869|NCT03443752|Other|Tai-Chi|The Tai-Chi training program will be ran over a period of 12 weeks. Classes will be conducted 3 times per week at the Movement Disorders Rehabilitation Centre in Waterloo, Ontario. The program will be conducted by a trained professional (principal investigator), and there will be volunteers who ensure the safety and well-being of participants.
15926870|NCT03443739|Other|Intermittent Fasting|Intermittent Fasting with abstinence from food and drink daily from sunrise to sunset for nineteen consecutive days in March 2018
15926871|NCT03443726|Procedure|Nerve block technique|Inferior alveolar nerve block with 1.8 cc of 4% articaine 1:100.000 epinephrine and 1.8 cc of the same anesthetic for the buccal nerve for third molar extraction.
15926872|NCT03443726|Procedure|Infiltrative technique|Infiltrative anesthesia buccally between first and second mandibular molar with 3.6 cc of 4% articaine 1:100.000 epinephrine and 0.6 cc lingually to the third molar using the same anesthetic solution.
15926873|NCT03443726|Drug|4% articaine 1:100.000 epinephrine|Articaine in a 4% solution with epinephrine 1:100,000 (Artinibsa; Inibsa Dental, Lliçà de Vall, Spain)
15926874|NCT03443726|Procedure|Third molar extraction|Third molar extraction under local anesthesia.
15926875|NCT03443713|Device|Dexcom G6 CGM|Subjects will wear a Dexcom G6 CGM for the 28 days they are on study.
15926876|NCT03443700|Device|EKSO-GT|Each rehabilitation session with EKSO-GT will last (operating time) 30-40 minutes. Such training will be carried out for 3 sessions per week, during the first 4 consecutive weeks of the study period (i.e. 12 total sessions per patient).
15926877|NCT03443700|Procedure|Standard neurorehabilitation locomotor training|Neurorehabilitation locomotor training will be performed according to standardized protocols shared within the scientific community, during the whole 8-week study period, 5 times per week, twice a day, for a total of about 2,5 hours per day.
15926878|NCT03443687|Behavioral|Pelvic Floor Physical Therapy|Pelvic floor exercises for 3 months under instruction of physical therapist
15926879|NCT03443687|Device|Home Biofeedback|Pelvic floor exercises for 3 months using biofeedback device
15926881|NCT03443661|Drug|FOLFOXIRI|oxaliplatin 85 mg/m2 irinotecan 150 mg/m2, 5FU 2,400 mg/m2 by 46 h infusion repeated at 2week intervals
15926882|NCT03443648|Procedure|External fixator assisted plaing|The plate length is marked on the skin. Limb reconstruction system (LRS) with one swivel clamp or Taylor Spatial frame (TSF) is used in all cases. The fixator is put in a plane parallel to that of the deformity. Two tapered pins are placed on either side of the planned osteotomy site and passed at a distance from the osteotomy so that they will not impede the subsequent internal fixation. Swivel clamps or the struts of the TSF are aligned in such a way that full correction is achieved. After osteotomy, swivel clamp is loosened and angular correction is achieved. Translation is carried out according to preoperative planning. If readjustment is required the swivel clamps or TSF struts are loosened and further correction is carried out. Once desired correction is achieved, the clamps or struts are tightened. Definitive internal fixation is carried out while external fixation holds the fragments. For internal fixation, locked T plate will be used.
15926883|NCT03443635|Behavioral|Treatment|The intervention educates subjects through the hands-on cooking and nutrition education classes how to buy, cook, store, and consume healthy foods as an adjunct to healthy activity levels and avoidance of such health risks factors as smoking, excessive alcohol intake, and drug use.
15926884|NCT03443622|Drug|SC-43 Oral Solution|SC-43 Oral Solution has drug substance of 1-[4-chloro-3(trifluoromethyl)phenyl-3-[3-(4-cyanophenoxy)] urea, or SC-43. SC-43 inhibits tumor growth through the activation of Src homology region 2 domain-containing phosphatase-1 (SHP-1) and the repression of p-STAT3 signalings. As a result of STAT3 inhibition by SC-43 treatment, decreased cell viability and enhanced apoptosis have been observed in cancer cells. The anti-tumor activity of SC-43 was also investigated in a variety of xenograft tumor models. Administration of SC-43 provides the tumor-bearing animals survival benefits, including the reduction of tumor volume and prolonged lifespan. SC-43 has been proposed to be evaluated as an anticancer therapeutic in in subjects with refractory solid tumors in the phase I trial.
15926885|NCT03443609|Diagnostic Test|68Ga-HBED-CC-PSMA PET / CT|Patient will receive a specific PET / CT with PSMA
15926886|NCT03443596|Biological|Early intensive BP control|Participants in the early intensive BP control arm are treated with BP lowering medications, with an aim to bring the systolic BP to 140-160mmHg and maintain this level for 72 hours post-ictus
15926887|NCT03443583|Other|Immediate Dentin Sealing or Delayed Dentin Sealing|The main difference between the IDS and DDS technique lies in the fact that in IDS, a thin layer of bonding resin is applied immediately after tooth preparation and prior to impression taking, whereas in DDS this layer is applied immediately before cementation of the restoration.
15926888|NCT03443570|Drug|Rituximab|given with a fixed dose of 500 mg administered as an intravenous infusion every two weeks, for 2 times totally
15926889|NCT03443570|Drug|Bortezomib|given subcutaneous injection at a fixed dose of 2.0 mg weekly, for 4 times totally
15926890|NCT03443557|Other|oral nutrition supplement|receiving prescription of oral nutrition supplement during hospitalization
15926891|NCT03443544|Procedure|Aggressive debridement|Aggressive debridement of the tissues undergoing fascitis
15926892|NCT03443531|Drug|Bufei Huatan granule|According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of qi deficiency of lung and phlegm-turbidity obstructing the lung will be given Bufei Huatan granule, twice daily for 24 weeks for lower dosage.
15926893|NCT03443531|Drug|Yifei Qinghua granule|According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of Qi and Yin deficiency of the lung and the phlegm-heat obstructing the lung will be given Yifei Qinghua granule, twice daily for 24 weeks for lower dosage.
15926894|NCT03443531|Drug|Placebo Bufei Huatan granule|According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of qi deficiency of lung and phlegm-turbidity obstructing the lung will be given placebo Bufei Huatan granule, twice daily for 24 weeks for lower dosage.
15926898|NCT03443518|Drug|Normal saline 0.9% IV infusion|Normal saline 0.9% IV infusion at the same rate of the Remifentanil infusion(0.05-0.1 μg/ kg/min).
15926899|NCT03443518|Drug|Remifentanil infusion|Remifentanil infusion with rate 0.03-0.1 μg/ kg/ min to achieve Visual Analog Scale (VAS) 3 or less
15926900|NCT03443505|Diagnostic Test|Neural respiratory drive measurement|"Neural respiratory drive (NRD) has been validated as an objective physiological biomarker in acute exacerbation of chronic obstructive pulmonary disease (AECOPD). Change in NRD during hospital admission has been demonstrated to be a marker of physician-defined clinical deterioration. NRD is a non-invasive measurement that involves skin preparation with a gel and alcohol wipe before placing 3 surface electrodes on the chest wall and collar bone to perform electromyography (EMG) of parasternal muscles. Electrodes are connected to an automated EMG analysis system to derive a measurement of NRD. Measurements take approximately 10 minutes with subject being monitored during normal (tidal) breathing and performing maximal sniff manoeuvres."
15926901|NCT03443492|Drug|S-1|Intervention is administered to patients in this Arm.
15926902|NCT03443492|Drug|Leucovorin(oral )|Intervention is administered to patients in this Arm.
15926903|NCT03443492|Drug|Gemcitabine|Intervention is administered to patients in this Arm.
15926904|NCT03443492|Drug|Oxaliplatin|Intervention is administered to patients in this Arm.
15926905|NCT03443492|Drug|Irinotecan|Intervention is administered to patients in this Arm.
15926906|NCT03443492|Drug|5-FU|Intervention is administered to patients in this Arm.
15926907|NCT03443492|Drug|Leucovorin(IV)|Intervention is administered to patients in this Arm.
15926908|NCT03443479|Device|Non-Invasive Ventilation|Treatment with Non-Invasive Ventilation by BiPAP. Different BiPAP models are in use. Ventilation parameters set at the discretion of the treating physician.
15926909|NCT03443479|Device|High-Flow Nasal Cannula|Treatment with a High-Flow Nasal Cannula. The Optiflow device by Fisher&Paykel used in all cases. Flow and fraction of inspired oxygen (FiO2) parameters at the discretion of the treating physician.
15926910|NCT03443466|Device|Epidural electrical stimulation (EES)|Using loss of resistance technique and electrical stimulation
15926911|NCT03443466|Device|Loss of resistance (LOR)|Using loss of resistance technique only
15926912|NCT03443453|Drug|MIV-711|MIV-711 administered as tablets and capsules at four occasions
15926913|NCT03443440|Other|Neurocognitive Testing|neurocognitive testing, computerized
15926914|NCT03443427|Biological|NTHi Mcat investigational vaccine (GSK3277511A)|Two doses administered intramuscularly at Day 1 and Day 61 in the deltoid region of the non-dominant arm and a third dose administered at either Day 181 or Day 361, according to each vaccination scheduling defined per protocol.
15926915|NCT03443427|Biological|Placebo|One dose administered intramuscularly at either Day 181 or Day 361 in the deltoid region of the non-dominant arm.
15926916|NCT03443414|Drug|RPL554 suspension|A dual PDE3/PDE 4 inhibitor
15926917|NCT03443414|Drug|Placebo|Placebo solution
15926918|NCT03443401|Procedure|Standard physical therapy care|standard plan of care delivered to patient with chronic low back within scope of licensure
15926919|NCT03443388|Device|Hövding inflatable helmet|The Hövding inflatable helmet is designed for cyclists as a collar with a deployable airbag that inflates when a sensor detects rapid changes in acceleration. The inflated helmet wraps the back and sides of the user's head in inflated nylon fabric which then slowly deflates after deploying.
15926920|NCT03443375|Other|Physical exercise|The interventions proposed in the present trial were based on a safe and well-established exercise training program
15926921|NCT03443362|Procedure|Punch Biopsy|A 3 mm punch biopsy will be taken from lesional and non-lesional skin as a routine procedure.
15926922|NCT03443362|Procedure|Blood sampling|Blood sampling
15926923|NCT03443349|Device|Vibwife One|"Vibwife One is a powered rotation bed intended to be used to assist in active mobilization of delivering women. Vibwife One imitates manual mobilization and position techniques. It is integrated in the mattress and fixed to the pelvis area of the birthing bed. Vibwife One can be used, when manual mobilization and position techniques are deemed appropriate.
~The device with all its functions is controlled over a remote control."
15926924|NCT03443323|Behavioral|Organizational Skills Training - School Based (OST-S)|OST-S is a small group skills training intervention, with parents and teachers supporting children's use of new skills. The program manual includes strategies for training and coaching school staff, referred to as school partners, to effectively implement OST-S and guidelines to modify the program for implementation in diverse schools with diverse students. Each student session includes: (a) homework review to assess completion of between-session skills implementation; (b) skill-building activities, which include the use of modeling, shaping, guided practice, and reinforcement for organized behavior; and (c) activities to promote generalization of skills. Sessions address four organizational challenges: (a) tracking assignments, (b) managing materials, (c) managing time, and (d) planning for long term assignments.
15926925|NCT03443310|Procedure|Ultrasound assessment of DVT|Using Ultrasound in assessing DVT in high-risk patients following hip fracture and major arthroplasty before the patients become symptomatic.
15926926|NCT03443297|Other|breast milk|Feeding with breast milk will be started in early feeding group from 24 to 48 hours of age or in late feeding group, from 48 to 72 hours of age. Initially 4 hourly feeding will be started with 0.5ml and 1 ml expressed breast milk in babies with birth weight <1200 grams and >1200 grams respectively. gradually volume of milk should be increased
15926927|NCT03443284|Behavioral|Health Partner|Health Partner is a combination of an iPhone or iPod Touch Operating System mobile application and a health care provider portal.
15926928|NCT03443284|Behavioral|Standard Care|Patients randomized to Control will receive pre-printed brochures that outline the steps of the care plan for unilateral TKA and THA, as per standard care provided to any unilateral TJA patient receiving care at Providence Health & Services.
15926929|NCT03443271|Procedure|TAP Block with Bupivicaine|Ultrasound guided TAP block will be performed and patient will be administered 20 ml of 0.25 % Bupivicaine on each side.
15926930|NCT03443271|Procedure|TAP Block with Placebo drug|Ultrasound guided TAP block will be performed and patient will be administered 20 ml of 0.9% Saline on each side.
15926931|NCT03443258|Other|Needs assesment tool integrated in nursing consultation.|Needs assessment tool consisting of 57 items related to functional, emotional, social and existential areas guide follow-up care and referral to multidisciplinary team rehabilitation e.g. dietician; speech-pathologist; psychologist, etc
15927703|NCT03437265|Drug|NER1006 powder for oral solution|NER1006 Dose 1 (1 sachet) and NER1006 Dose 2 (2 sachets)
15926932|NCT03443232|Procedure|Cryoballoon ablation|Cryoablation is performed using a single cryoballoon.In general, the cryoablation of each pulmonary vein is carried out twice. According to the objective condition, the operator determine whether or not to carry out an additional cryoablation. Then we will applicate electrophysiological substrate mapping for guiding ablation of atrial fibrillation,If mapping system detect a poor substrate,we should continue to ablate for left atrial roof and posterior line.
15926933|NCT03443232|Procedure|Radiofrequency ablation|Each patient randomly allocated into the radiofrequency ablation group receives circumferential pulmonary vein isolation(CPVI),The default strategy is to create a circle surrounding the two ipsilateral pulmonary veins.We will mapping the left atrial subtrate. If mapping system detect a poor substrate,we should continue to ablate for left atrial roof and posterior line.
15926934|NCT03443219|Device|Spritztube®|After preoxygenation, anaesthesia was induced with midazolam, propofol, and fentanyl,Spritztube® was inserted and both cuffs inflated
15926935|NCT03443219|Device|LMA Supreme™|After preoxygenation, anaesthesia was induced with midazolam, propofol, and fentanyl,LMA Supreme™ was inserted and both cuffs inflated
15926936|NCT03443206|Other|anonymous social support|Participants randomized to the intervention condition will be able to communicate with one another and offer social media-based forms of support (e.g., post music, photos, etc).
15926937|NCT03443206|Other|psychoeducation|educational materials related to mental health
15926938|NCT03443206|Other|online resources|links to online mental health resources
15926939|NCT03443193|Other|Exercise training|Patients will undergo three weekly exercise training sessions with periodized high-intensity interval training and resistance training for a period of 12 weeks.
15926940|NCT03443180|Other|Gluten and Amylase Trypsin Inhibitors (ATI)-free diet|Participants will be asked to avoid foods containing gluten and ATI (a similar protein found in grains) for 4 weeks.
15926941|NCT03443167|Behavioral|Training on emergency telephone numbers and mnemonics|"The intervention will consist in carrying out an initial theoretical training on how to act in case of attending an emergency, with graphic support of slides (power-point) during 5 minutes, followed by a practical part with the projection of the video of a song and with a role play activity for 15 minutes, to remember the helpline number for emergencies (112) and relate it to the mnemonic mouth-nose-eyes. At the beginning and at the end of the theoretical-practical activity, the evaluation questionnaires will be administered to each one of the students."
15926942|NCT03443167|Behavioral|Sham generic formation on the cardiopulmonary arrest.|The sham intervention for the control group will consist in providing a generic formation on the cardiopulmonary arrest, with graphic support of slides (power-point) during 10 minutes, without specifying the telephone number of assistance for emergencies or the mnemonics mouth-nose-eyes. At the beginning and at the end of the theoretical activity, the evaluation questionnaires will be administered to each one of the students.
15926943|NCT03443154|Diagnostic Test|VF-Test|A vaginal fluid test of interleukin-6 (IL-6) and alphafetoprotein (AFP).
15926944|NCT03443141|Drug|Vitamin E|The applied dressing will be embebbed in Vitamin E
15926945|NCT03443141|Drug|Standard dressing|The applied dressing is a normal one without adding any product to it.
15926946|NCT03443128|Drug|Vinorelbine|During each course, patients will be treated with vinorelbine (25mg/m2/week on weeks 1-3). After 1 course(4 weeks) of vinorelbine, response will be evaluated by simple assessment: clinical symptoms, signs, B ultrasound, chest X-ray, peripheral blood test and bone marrow smear(if needed). After 2 courses, response will be evaluatedy by simple assessment, CT and FDG-PET. The CR/CRu was defined by anatomic tumour shrinkage more than 75% after 2 courses based on CT with negative PET assessment, with negative bone marrow PCR(if needed) and without CNS involvement. Patients who achieved a CR/CRu after two courses either will proceed to stem cell transplantation (SCT) or will receive additional courses of therapy while awaiting SCT. Response was re-evaluated at the end of every 2 courses. Patients with progressive disease at any time during treatment will be removed from protocol therapy.
15926947|NCT03443089|Drug|Test formulation|Administration of a single intramuscular dose of an injectable formulation containing medroxyprogesterone acetate 25 mg/mL + estradiol cypionate 5 mg/mL after an overnight fast.
15926948|NCT03443089|Drug|Reference formulation|Administration of a single intramuscular dose of an injectable formulation containing medroxyprogesterone acetate 25 mg/ampole + estradiol cypionate 5 mg/ampole after an overnight fast.
15926949|NCT03443076|Dietary Supplement|EPA + DHA in SMEDS Formulation|A single dose of 500 mg EPA + DHA administered in a self-micro-emulsifying delivery system (SMEDS) formulation
15926950|NCT03443076|Drug|Lovaza|A single dose of 840 mg EPA + DHA administered as Lovaza
15926951|NCT03443063|Drug|Lemborexant|oral tablet
15926952|NCT03443050|Other|Unstable|This group will train over unstable surfaces to enhance balance abilities
15926953|NCT03443050|Other|Stable|This group will train over stable surface to enhance balance abilities
15926954|NCT03443037|Drug|amantadine sulphate|
15926955|NCT03443024|Biological|Lebrikizumab|Sterile liquid solution administered subcutaneously.
15926956|NCT03443024|Drug|Placebo|Solution administered subcutaneously.
15926957|NCT03443011|Radiation|Low dose CT without intravenous contrast|participants will receive an extra radiation dosage of about 3 milli Sievert (mSv) depending on patients height and weight. This is the radiation amount from the low dose CT protocol without intravenous contrast.
15926958|NCT03442998|Other|Suburban walk|Each subject is tested under the 'suburban' condition. We will compare the stress response and working memory response to walking in the two experimental conditions ((1)response to walking on a nature path and (2) response to walking on an urban sidewalk).
15926959|NCT03442998|Other|Nature walk|Each subject is tested under the 'nature' condition. We will compare the stress response and working memory response to walking in the two experimental conditions ((1)response to walking on a nature path and (2) response to walking on an urban sidewalk).
15926960|NCT03442985|Drug|Palovarotene 2.5 mg|Subjects will receive a weight-adjusted dose equivalent of 2.5 mg palovarotene, once daily, for up to 24 months.
15926961|NCT03442985|Drug|Palovarotene 5.0 mg|Subjects will receive a weight-adjusted dose equivalent of 5.0 mg palovarotene, once daily, for up to 24 months.
15926962|NCT03442985|Other|Placebo|Subjects will receive placebo, once daily, for up to 24 months.
15926963|NCT03442972|Drug|Teduglutide|Teduglutide
15926964|NCT03442972|Drug|Placebo|Placebo
15926965|NCT03442959|Other|Data record|characteristics of patients, initial clinical presentation of TNE, management of TNE (primary tumor resection or conservative strategy), five years follow up (locoregional recurrence, complication due to the surgery, complications related to the conservative strategy, death)
15926966|NCT03442933|Other|3 hours Road Cycling Time Trial|The road itinerary is a mixed route profile of 90 km, an elevation gain of 900 m, with mixed sections, flat, uphill and down over roads with little traffic.
15926967|NCT03442933|Other|3 hours Mountain Biking Time Trial|The mountain itinerary, is a mixed route of 55 km, an elevation gain of 600 m, with sections of wide tracks and trails, flat, uphill and down, with a medium technical difficulty.
15926968|NCT03442920|Other|Exercise|This group made exercise for 12 week/3 times a week.
15926969|NCT03442907|Procedure|24 hour blood pressure measurement, fluids, vasopressors|Targeting individual blood blood pressure values during surgical procedures
15926970|NCT03442907|Procedure|Standard of Care|Treatment according to Standard of care at the Department of Anaesthesiology, University Medical Centre Hamburg Eppendorf
15926971|NCT03442894|Procedure|Standard Physical Therapy Treatment|All three groups will receive manual therapy and exercise interventions provided by their physical therapist. The exact dosage and choice of exercise and manual therapy techniques will not controlled in the study. Documentation of dosage and utilization rates of each will be captured for each patient session in order to determine if these variables influence outcomes. A full shoulder exam will be conducted per standard of care at this time as well. Manual therapy and exercise interventions will be selected to address impairments uncovered in the shoulder exam.
15926972|NCT03442894|Procedure|Dry Needling|In addition to the standard PT interventions, the Dry Needling (DN) group will receive 6 DN sessions as part of their rehabilitation visits (they will occur at the same time). In 6 of the scheduled 10 visits, dry-needling intervention will be performed. They will have one DN session per week, which is consistent with typical clinical practice. After they complete their standard PT treatment, and while still in the clinic, the rotator cuff and periscapular muscles will be evaluated for the presence of MTrPs. Once located, the MTrPs will be treated with DN technique, as this is consistent with routine clinical practice. Potential muscles to receive TPDN treatment include the following: suprapsinatus, teres minor, infraspinatus, deltoid, upper trapezius, middle trapezius, levator scapula, pec major and pec minor.
15926973|NCT03442894|Procedure|Sham Dry Needling|In addition to the standard PT treatment, patients in the sham DN group will receive what appears to be a DN treatment, but it will not be done with the acupuncture needles and the skin will not be punctured. The Sham DN procedure will be performed over the site of identified MTrPs using a guide tube and a toothpick. A guide tube is positioned firmly over the area to be treated and a toothpick is inserted in the guide tube. The clinician taps the toothpick to mimic the skin prick from a needle and the guide tube is removed. The clinician maintains pressure on the end of the toothpick and moves the end furthest from the skin in different directions to mimic the pistoning and changes in needle angle that occur in actual dry needling. Care will be taken to treat from 1-3 muscle groups for 5-10 seconds per MrTP identified.
15926974|NCT03442881|Procedure|Excision of adnexal mass through laprotomy|Through laparotomy incision, the adnexal mass will be excised
15926975|NCT03442868|Device|high frequency rTMS|Participants receive 16 minutes (5Hz, 24 10-second trains with a inter-train interval of 30s) of high frequency rTMS applied to either primary motor cortex (M1), supplementary motor area (SMA) and dorsolateral prefrontal cortex (DLPFC) at different sessions. Walking performance is evaluated before and after the brain stimulation.
15926976|NCT03442829|Behavioral|Sweet food consumption|Sweet food consumption at breakfast
15926977|NCT03442829|Behavioral|Non-sweet food consumption|Non-sweet food consumption at breakfast
15926978|NCT03442816|Device|MHRC Camera|Evaluate the technical capabilities of the device to obtain quality images in reflectance and fluorescence imaging modes in a diverse population.
15926979|NCT03442803|Device|Target-Controlled Infusion|Propofol Target-Controlled Infusion
15926980|NCT03442790|Procedure|Agitated Saline Method|All patients in the study who have undergone a central venous line placement will undergo a confirmation of the accurate or inaccurate placement of central venous lines using agitated saline under ultrasound vision.
15926981|NCT03442790|Procedure|chest x-ray|All patients in the study who have undergone a central venous line placement will undergo a confirmation of the accurate or inaccurate placement of central venous lines using chest x-ray obtained in supine position as an active comparator
15926982|NCT03442777|Device|Allevyn® brand silicone adhesive multilayer foam dressings|Skin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Smith&Nephew (Allevyn® brand).
15926983|NCT03442777|Device|Mepilex® brand silicone adhesive multilayer foam dressings|Skin sites (restricted to sacrum, heel right/left and greater trochanter right/left) will be treated with silicone adhesive multilayer foam dressings by Mölnlycke Health care (Mepilex® brand).
15926984|NCT03442764|Drug|mavacamten|MYK-461
15926985|NCT03442764|Drug|Placebo|Placebo
15926986|NCT03442751|Drug|Paracel 1|Two drops every 60 seconds for 4 minutes
15926987|NCT03442751|Drug|Paracel Placebo|Two drops of Paracel Placebo every 60 seconds for 4 minutes followed by two drops every 30 seconds for 6 minutes
15926988|NCT03442751|Drug|Paracel 2 R0185|Two drops every 30 seconds for 6 minutes
15926989|NCT03442751|Device|KXL High Power System (2 J)|6 mW/cm2 for 11 minutes 6 seconds with an on/off cycle of 1 second UVA on/1 second UVA off (total UVA does of 2 J/cm2)
15926990|NCT03442751|Device|KXL High Power System (10 J)|30 mW/cm2 for 11 minutes 6 seconds with an on/off cycle of 1 second UVA on/1 second UVA off (total UVA does of 10 J/cm2)
15926991|NCT03442738|Procedure|Endocuff group|Endocuff Vision cap on Standard colonoscope
15926992|NCT03442725|Drug|Telotristat etiprate|Oral administration of 1 tablet of Xermelo® containing telotristat etiprate equivalent to 250 mg telotristat ethyl.
15927024|NCT03442491|Procedure|Hayman's Haemostatic Suture|After the uterus is exteriorised, bimanual compression is applied to check whether this stopped the bleeding, before the suture is applied. A number 2 polyglactin suture on a straight needle is used to transfix the uterus from front to back, just above the reflection of the bladder, and is then tied above the fundus of the uterus, while an assistant applies bimanual compression.
15927025|NCT03442478|Other|2D/3D Tomosynthesis|
15927761|NCT03436732|Drug|LMB-100|administered on days 1, 3 and 5 of each 21 day cycle for up to 4 cycles
15926993|NCT03442712|Other|Auricular acupressure plus smartphone App|Semen Vaccaria laccaria will be kept in place by a piece of adhesive patch. Seeds will be applied on one ear only, and seed plasters will be changed every 3 days to 4 days to the opposite ear, that is, we will meet the subjects twice per week. Subjects will be requested to apply pressure on the acupoints thrice per day, preferably within 30 min before eating, pressing for 20 times using a constant rhythm to each point. Coaching on how to self-administer AA on the acupoints will be given to the subjects, and a return demonstration from the subjects will be required to ensure the skills are performed properly. The subjects will install the smartphone App specifically designed for this study. The App will send out regular AA reminders to the subjects. In addition, the subjects will be asked to input the number of bowel open and compliance with AA performance per day into the App. The total treatment period will be 8 weeks.
15926994|NCT03442712|Other|Auricular acupressure|The participants will receive AA treatment and are required to perform daily self-administered seeds pressing, but no smartphone App will be provided, but a booklet containing relevant information will be provided to the subjects.
15926995|NCT03442699|Behavioral|Cognitive Behavioral Therapy|Up to 10 daily sessions of brief cognitive behavioral therapy for suicidal inpatients for about an hour each day.
15926996|NCT03442686|Behavioral|Compass Course|An 8-session group intervention that integrates education, support, self-reflection, and action-expectation to help people reaffirm or reconstruct self-grounded purpose after significant life events/transitions. The 8 sessions extend over 2-3 months, with 7 weekly sessions and the final session 1 month after Session 7. The intervention, called the Compass Course is structured around the 6 dimensions of flourishing (autonomy, self-acceptance, personal growth, relationships, purpose in life, external mastery), the goal of which is to help people enact behaviors that move them forward in reframing a sense of self and reaffirming or reconstructing a sense of purpose in their daily lives.
15926997|NCT03442673|Drug|Vinorelbine|Stimulation with vinorelbine together with G-CSF for mobilization of autologous stem cells
15926998|NCT03442673|Drug|Gemcitabine|Stimulation with gemcitabine together with G-CSF for mobilization of autologous stem cells
15926999|NCT03442673|Drug|G-CSF|Cytokine stimulation with G-CSF for mobilization of autologous stem cells
15927000|NCT03442660|Other|Data collection|Subjects will be treated in accordance with usual medical practice during their participation in this study. No additional diagnostic or treatment procedures will be required. Subjects will be asked to complete electronic (or on paper when it's not possible to use electronic version) questionnaires.
15927001|NCT03442647|Diagnostic Test|sinistrin clearance dynamic measurement|sinistrin clearance measurements will be performed before and 90 min after oral protein load
15927002|NCT03442634|Other|Early Hydration|this group will start oral hydration within 1 hour after cesarean section
15927003|NCT03442634|Other|Traditional Oral Hydration|this group will start oral hydration 6 hours after cesarean section
15927004|NCT03442621|Drug|Relacorilant Fasted|Relacorilant, presented as 7 x 50-mg white, hard gelatin capsules for oral administration, given following a 10.5 h fast
15927005|NCT03442621|Drug|Relacorilant with a high fat breakfast|Relacorilant presented as 7 x 50-mg white, hard gelatin capsules for oral administration, given following a 10 h fast and 0.5 h after the start of a high fat breakfast
15927006|NCT03442621|Drug|Relacorilant with a moderate breakfast|Relacorilant, presented as 7 x 50-mg white, hard gelatin capsules for oral administration, given following a 10 h fast and 0.5 h after the start of a moderate breakfast
15927007|NCT03442608|Procedure|Zoll 2000 and/or CureWrap 3500 cooling system|Device(Zoll 2000 and/or CureWrap 3500 cooling system),lasting 5 to 7 days, the core temperature will be controlled in 33-35 degree.
15927008|NCT03442595|Other|Intensive diabetes education and medication management|Patients receive intensive knowledge based diabetes education and algorithm driven medication management over a period of 12 weeks.
15927009|NCT03442582|Biological|Afluria Influenza Vaccine|"Afluria is a seasonal influenza vaccine
~Vaccine exposure in routine care (no vaccination per protocol)"
15927013|NCT03442556|Drug|Carboplatin|Given IV
15927014|NCT03442556|Drug|Docetaxel|Given IV
15927015|NCT03442556|Other|Laboratory Biomarker Analysis|Correlative studies
15927016|NCT03442556|Drug|Rucaparib Camsylate|Given PO
15927017|NCT03442556|Drug|Rucaparib|Given PO
15927018|NCT03442543|Device|preoperative localization of SLN detected by CTLG by either methods|50 patients with node negative early breast cancer. The patients were randomized into two groups; SLN localized using CTLG guided injection of liquid charcoal suspended solution (first group) or by placing a 3 cm silver wire using spinal needle (second group). For every patient, SLN biopsy was performed using the traditional method with blue dye. Then dual search for the SLN localized by both the novel & traditional method was performed.
15927019|NCT03442530|Behavioral|ToPIC|Expanded tobacco cessation counseling for pregnant women.
15927020|NCT03442530|Behavioral|Tobacco Treatment As Usual (TTAU)|Standard of care tobacco cessation counseling for pregnant women
15927021|NCT03442517|Behavioral|Behavior Lifestyle Intervention|Participants will be involved in group-based counseling. Sessions will be about 1 hour each and comprise up to 10 people. The sessions will be led by a trained health educator. The calls will be a chance for participants to discuss challenges with breastfeeding, problem solving skills, educational information, and discuss balanced diet topics.
15927022|NCT03442517|Other|Usual prenatal care|Participants will receive the standard education given by their OBGYN or other healthcare provider. No additional breastfeeding, nutrition or postpartum weight loss education will be provided to participants by the investigators during pregnancy. After delivery, participants will follow normal pediatric visit schedule.
15927023|NCT03442504|Diagnostic Test|FES PET/CT|"There will be no premedication or other treatment before and after PET FES. PET / CT will be performed at the center level on a hybrid PET camera.
~The first TEP FES acquisition begins at the time of injection and continues for 30 minutes,
~The second acquisition of 20 minutes takes place 60 minutes after the injection is a total of 50 minutes of imaging and 1:30 in the service."
15927114|NCT03441828|Drug|Moderate Neuromuscular Block|maintenance of a moderate neuromuscular block.
15927115|NCT03441815|Drug|XC8|
15927026|NCT03442465|Behavioral|Toronto Extremity Salvage Score|Participant-reported outcome score. For lower extremities, this is a 33 item questionnaire containing 32 5 point Likert scale items and 1 open ended response item. For upper extremities, this is a 31 item questionnaire containing 31 5 point Likert scale items and 1 open ended response item. Individual item responses range from 1-5 with higher values indicating a task is easier to complete. A total questionnaire score can also be calculated by taking the sum of the scores minus the number of total items answered, and dividing this by the maximum possible score based on the number of items answered. This results in a range from 0 -100% with higher values indicating greater ability to complete tasks 31. This scoring allows for the fact that some items may not be answered if they do not apply to an individual. It is anticipated that it will take 20 minutes to complete. Scores for the lower extremity and upper extremity may be combined, but we intend to treat them separately for analysis.
15927027|NCT03442465|Behavioral|Musculoskeletal Tumor Society Score|Clinician-reported global score. For lower extremities, this is a 6 item questionnaire containing 6 point Likert scale items which cover pain, function, emotional acceptance, walking ability, gait, and necessary support. Individual item scores range from 0-5 with higher values indicating greater function, less pain, or more positive emotional acceptance. For upper extremities, this is a 6 item questionnaire containing 6 point Likert scale items which cover pain, function, emotional acceptance, hand positioning, manual dexterity, and lifting ability. Individual item scores range from 0-5 with higher values indicating greater function, less pain, or more positive emotional acceptance. A total questionnaire score which is defined as the sum of the individual items divided by the maximum possible score (5 times the number of items) may also be computed. It is represented as a percentage from 0 - 100%.
15927028|NCT03442465|Behavioral|Timed Get Up and Go Test|Validated functional measurement, for lower extremities only. The patient is observed and timed while s/he rises from an arm chair, walks 3 meters, turns, walks back, and sits down again. The test predicts the patient's ability to go outside alone safely and quantifies functional mobility. The test requires no special equipment and will take less than one minute to complete.
15927029|NCT03442465|Diagnostic Test|Orthogonal Radiographs|The distance of bone transport is measured, accounting for calibration of the radiographs. The presence of bone regenerate between the transported segment is determined by the presence of continuous calcified callus from the proximal segment to the distal segment. Each of the orthogonal radiographs is used to visualize two cortices: the AP radiographs visualizes the medial and lateral cortices and the lateral radiograph measures the anterior and posterior cortices. Each continuous calcified cortex is counted with a range from 0 to 4 cortices intact.
15927030|NCT03442465|Diagnostic Test|Weight Bearing for lower extremities only|As part of the current standard of care, patients are asked to stand on a scale with the affected lower extremity on the scale and the unaffected extremity on a block which is level with the scale. The patient is asked to place as much weight as possible on the affected extremity and this weight Is recorded. Each patient's total weight is then measured and the percent of weight bearing is calculated as the amount of weight bearing over the total body weight.
15927031|NCT03442465|Diagnostic Test|Range of Motion|As part of the current standard of care, the joints of the affected extremity are assessed for passive range of motion at each follow up visit by the clinician. If surgery is on the femur, the hip and knee joints are assessed for range of motion. Whereas for the tibia, the knee and ankle joints are assessed. These assessments would be measured using a goniometer placed alongside the extremity and recorded for each direction of movement. Hip range of motion includes flexion, extension, abduction, internal rotation and external rotation. Knee range of motion includes flexion and extension. Ankle range of motion includes dorsiflexion and plantarflexion.
15927032|NCT03442465|Diagnostic Test|Osteocalcin|This lab assesses bone metabolism and require 5 mL of blood
15927033|NCT03442465|Diagnostic Test|Amino terminal propepetide of type 1 collagen|This lab assesses bone metabolism and require 5 mL of blood
15927034|NCT03442465|Diagnostic Test|N-telopeptide of type 1 collagen|This lab assesses bone metabolism and require 5 mL of blood
15927035|NCT03442452|Other|Electronic Decision Aid Tool|The AML Decision Aid tool consists of ten video modules, approximately 3 minutes each, containing content regarding key areas such as an explanation of what AML is, treatment choices, and things to consider when determining a treatment path.
15927036|NCT03442439|Behavioral|Nutrition and Play Intervention|Mothers and children in the Nutrition and Play group will play educational and nutrition-focused games.
15927037|NCT03442439|Behavioral|Family Nurture Intervention|The mother-child pair will be asked to talk and play with each other as they customarily do. If the child becomes restless and dysregulated the mother will be coached by the Nurture Specialist to bring the child back into a calm state though sustained physical contact; comfort touch, soothing words, and eye contact.
15927038|NCT03442426|Other|Integrated model of primary care|Intervention includes: 1) consistent risk screening and assessment; 2) care coordination and system navigation; 3) patient/caregiver engagement and shared decision-making; and 4) enabling technology supports.
15927039|NCT03442413|Drug|2-[18F]-FA PET/CT|2-[18F]FA is a highly specific radiotracer which has been used successfully to image nicotinic acetylcholine receptors in the human brain to characterize the effects of nicotine exposure (via smoking) on these receptors.
15927040|NCT03442413|Drug|I.V. Nicotine|Subjects in our study will receive intravenous nicotine at the adaptation session and each of the PET scans, close to the amount of nicotine absorbed from smoking 1/10 cigarette.
15927041|NCT03442400|Device|Volcano iFR/FFR Verrata Plus coronary pressure/flow wire|We will measure the degree of flow-limitation of intermediate severity coronary steonses using the iFR/FFR Verrata Plus coronary pressure/flow wire before and after transcatheter aortic valve replacement.
15927042|NCT03442387|Other|Frame of numerical information|Each group received only one frame of information.
15927043|NCT03442374|Other|Exercise|The exercise protocol consists of 1 set of 20 repetitions (range 15-25 reps) at a rate of 5 seconds/repetitions with a starting weight of 60-80% of their computerized strength score. Patients will be instructed to target an exertion level of 7/10 on the Borg Rate of Perceived Exertion (RPE) scale within their available passive ROM range into flexion-extension
15927044|NCT03442348|Dietary Supplement|Omega 3 fatty acid|Participants in the bottom median of dietary fibre intake (<15 g per day) will be randomised into one of two arms. Participants in the second arm (N>32) will be required to take one 500mg capsule of Omega 3 along with a meal daily for 6 weeks.
15927116|NCT03441815|Drug|Placebo|
15960802|NCT03182426|Drug|Etanercept|Anti-inflammatory
15927045|NCT03442348|Dietary Supplement|Inulin fibre|The participants in the control arm (N>32) will be asked to take 20 g of fibre (resistant starch + inulin) per day that are known favour production of SCFAs in the colon for a period of 6 weeks. The inulin powder will be provided in pre-weighed sachets containing 10g each which can be taken mixed in water or a suitable beverage of choice taken twice (morning and evening) per day.
15927046|NCT03442335|Diagnostic Test|Chromohysteroscopy|Standard hysteroscopy followed by injection of a dye, in this case iodine.
15927047|NCT03442335|Diagnostic Test|Endometrial biopsy (Pipelle)|A narrow plastic tube (Pipelle) is passed through the cervix to aspirate a sample of endometrial tissue.
15927048|NCT03442322|Other|transdisciplinary approach|This approach is integrated across disciplines and provides core training for all providers, staff members, and stakeholders, using a common language to address care concerns and support continuity and sustainability;
15927049|NCT03442322|Other|multidisciplinary approach|This is a problem-based approach that draws on the expertise of individual healthcare providers (e.g., occupational therapy) to address care concerns.
15927050|NCT03442309|Device|Silver Diamine Fluoride|Silver diamine fluoride (SDF)
15927051|NCT03442309|Device|Fluoride Varnishes|Fluoride varnish (FV)
15927052|NCT03442309|Device|Glass Ionomer|Glass Ionomer Sealants (GC Fuji IX)
15927053|NCT03442296|Behavioral|Baltimore HEARS|Tailored aural rehabilitation for participant and communication partner (if applicable)
15927054|NCT03442296|Device|Baltimore HEARS|Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
15927055|NCT03442283|Dietary Supplement|Vitamin mineral supplementation|supplementation with a vitamin or mineral: vitamin A, β-carotene, B1, B2, B3 (niacin), B6, B10 (folic acid), C, D and E, calcium, iron, zinc, magnesium and selenium. Also, multivitamins, antioxidants, B-complex and the combination of calcium and vitamin D.
15927056|NCT03442270|Other|No Intervention|This is an observational study, so standard of care will be followed.
15927057|NCT03442257|Behavioral|SMS|The experimental treatment will consist of health promoting text messages addressing metabolic risk factors associated with cardiovascular disorders in patients with hypertension. Participants will receive four semi-personalized messages per week in addition to their usual care. The text messages will be developed to support healthy life style changes i.e. regarding general cardiovascular health, tobacco use, physical activity and diet.
15927058|NCT03442244|Drug|LEO 90100 foam|Each subject has each of the 2 treatments applied at the same time on 2 different sites on the back
15927059|NCT03442244|Drug|Vehicle of LEO 90100 foam|Each subject has each of the 2 treatments applied at the same time on 2 different sites on the back
15927060|NCT03442231|Device|Journey UNI Unicompartmental Knee System|Lateral or medial knee compartment replacement
15927061|NCT03442218|Drug|Clorhexidine|Vaginal wash with clorhexidine solution previous to cesarean section in patients with premature rupture of membranes.
15927062|NCT03442218|Drug|Saline solution|Vaginal wash with saline solution previous to cesarean section in patients with premature rupture of membranes.
15927063|NCT03442205|Procedure|LC + LCBDE + ENBD + primary closure of CBD|LC + LCBDE + ENBD + primary closure of CBD
15927064|NCT03442205|Procedure|ERCP technique + LC|ERCP technique + LC
15927065|NCT03442205|Procedure|LC + LCBDE + primary closure of CBD|LC + LCBDE + primary closure of CBD
15927066|NCT03442192|Other|PrEP Care Anywhere Services|"PrEP Virtual Clinic Visits. PrEP clinical care will follow guidelines as established by the CDC for PrEP clinical evaluation and follow-up. Appointments will be set up in the same process as any practice visit and require the same clinical documentation and billing requirements, but will have a separate clinic designation for the visit type. At any time during the study, a patient can request a face-to-face visit with the provider. The provider may also request a face-to-face visit based on patient presentation and/or laboratory results.
~The typical visit options will include:
~On demand peer interim visits- participants can text, chat (via PrEPme app) or call to access an on demand virtual support visit with a peer Case Manager (CM).
~HIV and Sexually Transmitted Infection (STI) at Home Self-Testing"
15927067|NCT03442179|Device|EEG|the anesthesiologists (attending faculty, residents, and CRNAs) in the treatment group use the unprocessed EEG waveforms and EEG spectrogram to maintain appropriate levels of unconsciousness for general anesthesia while avoiding burst suppression. The presence of slow (0.1-1 Hz) and frontal alpha (8-12 Hz) oscillations on EEG time trace and spectrogram will be used as indicators of anesthesia-induced unconsciousness in these patients who are receiving propofol and sevoflurane for induction and maintenance of general anesthesia, respectively.
15927068|NCT03442166|Radiation|LED group|The patients (n=17) will receive daily intra and extra oral LED applications from the immediate postoperative period up to 7 days after the surgical procedure. The LED irradiation will be performed in two areas, one intra and one extra oral. The LED to be used in the intraoral site will be red, 660+/-20nm wavelength, 5 mW power, 2.7J/cm2 energy density for 7 min, 2J energy per point, knowing that the 6 irradiated spots will have 12J in total. In the extra oral site the infra-red LED will be used, 850+/-20nm wavelength, power of 5mW, 3.8J/cm2 of energy density for 10 min, 3J of energy per point, knowing that 36 will be irradiated, so we will have 108J in total.
15927069|NCT03442166|Radiation|Sham group|Patients will be treated in the same way as the LED group. The person in charge of the application will simulate the intraoral and extraoral irradiation by positioning the LED in the same locations described for the LED group, but the equipment will be kept off. So that the patient does not identify the sound of activation of the device (beep), it will be recorded, and connected at the time of application.
15927070|NCT03442153|Dietary Supplement|Solgar No7 Complex|Solgar No7 Capsules
15927071|NCT03442153|Dietary Supplement|placebo|Placebo tablets Cellulose
15927072|NCT03442140|Other|Harmonica playing|Patients will play the harmonica for up to 6 months
15927073|NCT03442127|Behavioral|CaringGuidance™ After Breast Cancer Diagnosis|Web-based, psychoeducational, self-management tool
15927074|NCT03442114|Behavioral|Hydroxyurea SDM Toolkit|Implementation tools and visit decision aids
15927075|NCT03442114|Behavioral|Clinician Pocket Guide|current hydroxyurea protocol and ASH pocket guide
15927117|NCT03441802|Other|High quality extra virgin olive oil|Cases and controls were given 40 g/die high quality extra virgin olive oil
15927118|NCT03441789|Drug|Enstilar|Enstilar foam applied to affected areas daily
15927119|NCT03441789|Drug|Vehicle|vehicle foam applied to affected areas once daily
15927076|NCT03442101|Drug|Patients with psychosis will be treated with known antipsychotic medication|Subjects with first episode psychosis will be treated with risperidone, the most frequently used antipsychotic drug (APD) for 32 weeks. The study will follow a rigorous longitudinal design to capture treatment response whereby those without an adequate response after 16 weeks of treatment will be switched to aripiprazole, another APD for 16 weeks. All patients will be scanned four times: at baseline and after 6, 16, and 32 weeks of treatment.
15927077|NCT03442088|Drug|Apremilast|Apremilast will be given as approved by the FDA for the treatment of moderate to severe plaque psoriasis. An initial dosage titration from Day 1 (10mg) to Day 5 (30mg). Following the titration, the recommended maintenance dosage of 30 mg twice daily taken orally starting on Day 6 will be dispensed, as per labeled indication.
15927078|NCT03442062|Other|Assessment Feedback Incentives and eXchange|The adolescent AFIX (Assessment, Feedback, Incentives, and eXchange) Program is a quality improvement strategy developed by the CDC to improve the immunization practices and vaccination coverage levels of public and private health care providers. It has four main components: 1) Assessment of a provider's current immunization practices and vaccination levels, 2) Feedback of the assessment results and strategies to improve coverage levels, 3) Incentives to improve coverage levels, and 4) eXchange of information and resources necessary to facilitate improvement. Relevant AFIX information will be communicated to vaccine providers using several intervention and quality improvement components.
15927079|NCT03442062|Other|Physician-to-physician engagement|Physician-to-physician engagement is a quality improvement strategy in which trained physician educators deliver a 60 minute consultation via interactive webinar. The consultations will be delivered to providers in primary care clinics and will include didactic instruction on HPV-related cancers, HPV vaccination, communication training, and assessment and feedback about each clinics' vaccination coverage.
15927080|NCT03442062|Other|Active Intervention Control|Active Intervention Control will be a remotely delivered quality improvement strategy on a clinical topic other than HPV vaccination.
15927081|NCT03442049|Other|Physiotherapy - Study group|Study group : In addition to home program spinal stabilization exercises
15927082|NCT03442049|Other|Physiotherapy - control group|Home exercise program
15927083|NCT03442036|Device|Suture-Method Technique|Perineural catheters are attached to the back of a hollow suture-shaped needle that pulls the catheter adjacent to the target nerve
15927084|NCT03442036|Device|Through-the-Needle Technique|Perineural catheters are inserted through a straight hollow-bore needle
15927085|NCT03442023|Drug|Chlorhexidine gluconate at 2%|Mouth Rinse with Chlorhexidine gluconate at 2% every 12 hours, one week.
15927086|NCT03442023|Drug|Chlorhexidine gluconate at 0.12%|Mouth Rinse with Chlorhexidine gluconate at 0.12% every 12 hours, one week.
15927087|NCT03442010|Other|Detection of adverse drug events|Detection of adverse drug events
15927088|NCT03441997|Other|Mind-body exercise|Exercise program.
15927089|NCT03441997|Other|Light mobility exercises|Modified mind-body program.
15927090|NCT03441984|Drug|Treatment A|TRIUMEQ (Adult) administered as a, single dose, fixed dose combination (FDC) tablet - DTG 50 mg/ABC 600 mg/3TC 300 mg as 1 conventional tablet, orally as direct-to-mouth.
15927091|NCT03441984|Drug|Treatment B|TRIUMEQ (Pediatric) administered as a, single dose, FDC tablet - DTG 5 mg/ABC 60 mg/ 3TC 30 mg, orally as 10 dispersible tablets
15927092|NCT03441984|Drug|Treatment C|TRIUMEQ (Pediatric) administered as a, single dose, FDC tablet - DTG 5 mg/ABC 60 mg/3TC 30 mg, orally as direct-to-mouth.
15927093|NCT03441984|Drug|Treatment D|"DTG and 3TC (Adult), administered as a, single dose, Single dose, 1 tablet DTG (50 mg) and
~1 tablet 3TC (300 mg), orally as direct-to-mouth."
15927094|NCT03441984|Drug|Treatment E|DTG and 3TC (Pediatric) administered as a, single dose, FDC tablet single dose, FDC tablet - DTG 5 mg/3TC 30 mg, orally as 10 dispersible tablets.
15927095|NCT03441984|Drug|Treatment F|DTG and 3TC (Pediatric) administered as a, single dose, FDC tablet single dose, FDC tablet - DTG 5 mg/3TC 30 mg, orally as direct-to-mouth.
15927096|NCT03441971|Device|GORE PV1|Implantation of GORE PV1 Device for procedure to replace the pulmonary valve and reconstruct the right ventricular outflow tract (RVOT).
15927097|NCT03441958|Biological|ECT-001 (UM171) expanded cord blood|ECT-001 expanded cord-blood will be produced and infused on site
15927098|NCT03441945|Other|magnetic steering|magnetic steering
15927099|NCT03441932|Procedure|Fiberoptic endoscopic evaluation of swallowing (FEES)|"Subjets within the two groups will after than have FEES with videotaping of pharyngeal phase after giving subjects a standardised food consisting of thin Puree."
15927100|NCT03441919|Radiation|PET-CT (positron emission tomography - computer tomography)|PET-CT to determine vascular inflammation
15927101|NCT03441919|Diagnostic Test|Blood drawn|Blood drawn
15927102|NCT03441893|Diagnostic Test|parasitological diagnostics (coproscopy)|Three stool samples for parasitological examination will be taken from ulcerative colitis patients at 1-2 days interval.
15927103|NCT03441893|Drug|Nitazoxanide 500Mg Oral Tablet|Tab. nitazoxanide by a 1.0 g/day (two pills) twice over orally for 14 consecutive days
15927104|NCT03441893|Drug|Mesalazine 250Mg Tablet and nitazoxanide 500Mg Oral Tablet|Tab. nitazoxanide by a 1.0 g/day (one pill - 500 mg) twice over orally and mesalazine 1.5 g/day (one pill - 500 mg) three times a day orally for 14 consecutive days
15927105|NCT03441893|Drug|Mesalazine 250Mg|Tab. mesalazine ≥3 g/day (one pill - 500 mg) three times a day orally for 14 consecutive days
15927106|NCT03441867|Behavioral|Cognitive Behavioral Therapy for Seizures|CBT-informed psychotherapy for patients with PNES and PTE
15927107|NCT03441867|Other|Standard Medical Care|Observational - standard medical care
15927108|NCT03441854|Device|HFNC group|Application of HFNC oxygen delivery after extubation.
15927109|NCT03441841|Drug|Lidocaine + Prilocaine|Single topical dose of 2g lidocaine + prilocaine 2.5 % formulation.
15927110|NCT03441841|Drug|Lidocaine|Single topical dose of 2g lidocaine 2.5 % formulation.
15927111|NCT03441841|Drug|Prilocaine|Single topical dose of 2g prilocaine 2.5 % formulation.
15927112|NCT03441828|Procedure|Quality of surgical field conditions|evaluation of the intraoperative surgical conditions assessed by the surgeon as a 5 points scale (Optimal= 5 points/ Good= 4 points / Adequate= 3 points / Poor = 2 points / Inadequate = 1 point) given by deep vs moderate neuromuscular block
15927113|NCT03441828|Drug|Deep Neuromuscular Block|maintenance of a deep neuromuscular block by infusion of rocuronium
15927120|NCT03441789|Drug|Otezla|Otezla 30mg
15927121|NCT03441776|Other|Generalized Vestibular Rehabilitation Treatment|These treatment visits are available twice a week and each visit lasts 45 minutes. Individuals receiving GVRT are allowed to choose the frequency at which they want to attend and the program is designed for each subject to complete 8 visits within a period between 4 and 8 weeks. The ideal number of patients receiving treatment at each class is from 3 to 6 but the system has capacity for a maximum of 8. GVRT is a standard of care treatment option and is not considered research.
15927122|NCT03441776|Other|Individualized Vestibular Rehabilitation Treatment|Individuals receiving IVRT are scheduled depending on their individual needs and PT availability. These visits require one-on-one time with a PT. Individuals are commonly seen by the PT 3 times at two week intervals. These visits last 30 minutes and include PT evaluation designed to instruct patients on exercises for them to perform on their own. IVRT is a standard of care treatment option and is not considered research.
15927123|NCT03441763|Device|Emed foot device|foot pressure will be measure by using emed foot pressure system
15927124|NCT03441750|Drug|metformin|Metformin tablets will be administrated in the experimental arm.
15927125|NCT03441750|Other|Standard lifestyle intervention|"Standard lifestyle advice will be united for all subjects by providing special booklet.
~All participants will receive 20-30 minutes individual or group session with assigned nurse addressing the harm of prediabetes and the importance of a healthy lifestyle for preventing Diabetes.
~The amount of energy intake of the participants will be calculated based on the ideal body weight and physical activity levels. The sample recipe will be explained by the nurse and provided in the diet instruction.
~Moderate intensity physical activity (150 minutes per week) is recommended.
~Smoking cessation is encouraged for the smoker.
~Excessive alcohol intake is encouraged to avoid."
15927126|NCT03441737|Behavioral|Exercise|20 minutes of aerobic exercise (walking on a treadmill) at 2/3 of participant's maximum heart rate (maximum heart rate calculated as 220-age).
15927127|NCT03441737|Behavioral|Non-Exercise|20 minutes of sitting in the laboratory with access to magazines and the internet.
15927128|NCT03441724|Diagnostic Test|Mechanocardiography|Mechanocardiographic recording
15927129|NCT03441698|Device|Genuine acupuncture (A)|A) Acupuncture is administered bilaterally to the acupuncture point PC6 located two body-inches proximal of the wrist crease, between the tendons of palmaris longus and flexor carpii radialis. Sharp acupuncture needles were inserted into a depth of a half body-inch. The needles are manipulated three times (at the start, middle and end of the treatment session) by twirling and lifting until deqi occurs. Within the groups A, B and C, the participants are randomized to two communication types: 1) neutral communication or 2) strengthened positive communication regarding expected relaxing effects of their treatment, using a standardized communication model.
15927130|NCT03441698|Device|Sham acupuncture (B)|B) Sham acupuncture is administered bilaterally to a non-acupuncture point two body-inches proximal and one body-inch radial from PC6. The telescopic Park Sham Device was used. The needle looks identical to a real needle, but is blunt and glides upward into its handle instead of penetrating. The marking tubes holds the needle in place. The therapist give an illusion of manipulating the needle by turning it three times until it touched the skin, but no deqi occurs. Within the groups A, B and C, the participants are randomized to two communication types: 1) neutral communication or 2) strengthened positive communication regarding expected relaxing effects of their treatment, using a standardized communication model.
15927131|NCT03441698|Other|Rest|C) Rest means resting for 30 minutes, either sitting or lying down. Within the groups A, B and C, the participants are randomized to two communication types: 1) neutral communication or 2) strengthened positive communication regarding expected relaxing effects of their treatment, using a standardized communication model.
15927132|NCT03441685|Behavioral|Semantic cues (perform action), syntactic cues (sentence frame), or combined semantic and syntactic cues|"Verb Learning Session Teaching phase. The examiner labels each target word and performs the action 6 times in each condition. She elicits the target word from the participant 2 times per word per condition and provides feedback on accuracy.
~Testing phase. Receptive probes are administered after every 2 words are taught. Expressive probes are at the end of the condition. For receptive probes, the examiner asks the participant to identify novel verbs and for expressive probes, the examiner asks the child to label the novel action. Testing after 2 items is designed to decrease memory load. Participants have a brief break between conditions.
~Data are collected on: a) child responses on standardized assessments, (b) responses to verb learning probes, (c) parent responses to intake form, and (d) relevant medical history from electronic medical record.
~None of the above procedures present more than minimal risk to participants or research staff. Vanderbilt IRB approved all procedures."
15927133|NCT03441672|Behavioral|Meaning of Screening|Interactive technology game providing education about prenatal screening and what the results may mean.
15927134|NCT03441659|Procedure|ACL reconstruction|Surgical ACL reconstruction
15927135|NCT03441633|Drug|apixaban|current or new medication
15927136|NCT03441633|Drug|dabigatran|current or new medication
15927137|NCT03441633|Drug|VKA|current or new medication
15927138|NCT03441633|Drug|rivaroxaban|current or new medication
15927139|NCT03441620|Dietary Supplement|strawberries|Freeze-dried strawberry powder
15927140|NCT03441620|Other|Control powder|Control powder matched for fiber and strawberries
15927141|NCT03441607|Drug|mHACMb|Active ingredient
15927142|NCT03441607|Other|placebo|inactive ingredient
15927143|NCT03441581|Drug|Eluxadoline|Eluxadoline 100 mg oral tablets BID with food.
15927144|NCT03441568|Device|Modified Diprobase formulation (BAY987534)|The modified Diprobase formulation will be applied topically twice daily over 14 days on the whole body and face.
15927145|NCT03441555|Drug|Venetoclax|tablet, oral
15927146|NCT03441555|Drug|Alvocidib|Intravenous
15927147|NCT03441542|Behavioral|Data-assisted Case Navigation|"The researchers will develop a monthly task list for the patient navigator with patient by patient care cascade and treatment milestones that need to be accomplished per patient in the case group. The researchers will deliver the spreadsheet and the task list to the Grady Liver Clinic Director who will use it to direct and supervise the activities of the patient navigator.
~Patient navigators will be responsible for reaching out to patients in only the intervention arm about their next step in the HCV care cascade."
15927351|NCT03439995|Other|Conventional ventilation|Lower PEEP, standard tidal volume mechanical ventilation
15927352|NCT03439982|Biological|FMT|FMT processed from routinely screened donors
15927148|NCT03441542|Behavioral|Standard of Care|Patients will be recruited into the study by the patient navigator, be provided information about HCV infection, and will be informed that treatment is freely available should they seek it. Patients will also be provided contact and address information for the treatment clinic.
15927149|NCT03441529|Drug|Lumicitabine|Participants will receive single oral dose of 1000 mg lumicitabine as per assigned treatment sequence.
15927150|NCT03441529|Drug|Piperacillin/Tazobactam|Participants will receive three IV infusions of piperacillin/tazobactam combination product (4 g of piperacillin and 0.5 g of tazobactam) every 6 hours on Day 1.
15927151|NCT03441516|Drug|Alfoatirin® Tab. + Aripezil® Tab.|Choline Alphoscerate 400 mg Oral Tablet bid + Donepezil 10 mg Oral Tablet qd for 24 weeks
15927152|NCT03441516|Drug|Aripezil® Tab.|Donepezil 10 mg Oral Tablet qd for 24 weeks
15927153|NCT03441503|Other|Child HCAHPS: Automated day-of-discharge survey|Child HCAHPS surveys will be administered on the day of discharge via an electronic interactive patient care system on inpatient televisions.
15927154|NCT03441490|Behavioral|Guided-ICBT for adolescents with anxiety|Internet-based cognitive behavioural therapy with therapeutic guidance through mail, 8 weeks.
15927155|NCT03441490|Behavioral|Guided-ICBT with chat|Internet-based cognitive behavioural therapy with therapeutic guidance through chat, 8 weeks.
15927156|NCT03441490|Behavioral|Guided-ICBT with learning support|Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through mail, 8 weeks.
15927157|NCT03441490|Behavioral|Guided-ICBT with learning support and chat|Internet-based cognitive behavioural therapy with learning support and therapeutic guidance through chat, 8 weeks.
15927158|NCT03441464|Combination Product|LUM Imaging System|Patients will be injected with one of 3 study doses of LUM015, or have no LUM015 intervention, and resected tissue will be imaged ex vivo with the LUM imaging device.
15927159|NCT03441438|Dietary Supplement|Water|Serum and urine markers will be obtained after drinking 5 oz of water
15927160|NCT03441438|Dietary Supplement|Red wine|Serum and urine markers will be obtained after drinking 5 oz of water
15927161|NCT03441438|Dietary Supplement|Polyphenolic Compounds|Serum and urine markers will be obtained after consuming 100 mg of provinols powder
15927162|NCT03441425|Other|Unexpected death|
15927163|NCT03441412|Drug|Ticagrelor 90mg|"2 x 90 mg of ticagrelor will be administered orally to the subjects. Two hours after administration, the registrations and blood sampling are repeated after which an infusion of epinephrine diluted in glucose solution (5%) is started at a weight-adjusted rate of 0.01, 0.05, 0.10 and 0.15 μg kg-1 min-1. Each infusion will be maintained for 15 minutes.
~After the measurement at the highest dose of epinephrine, 5 mg metoprolol (Abcur, Haelsingborg , Sweden) will be given intravenously to the study subject and thereafter registrations and blood sampling will be repeated."
15927164|NCT03441412|Drug|Epinephrine|"2 x 90 mg of ticagrelor will be administered orally to the subjects. Two hours after administration, the registrations and blood sampling are repeated after which an infusion of epinephrine diluted in glucose solution (5%) is started at a weight-adjusted rate of 0.01, 0.05, 0.10 and 0.15 μg kg-1 min-1. Each infusion will be maintained for 15 minutes.
~After the measurement at the highest dose of epinephrine, 5 mg metoprolol (Abcur, Haelsingborg , Sweden) will be given intravenously to the study subject and thereafter registrations and blood sampling will be repeated."
15927165|NCT03441412|Drug|Metoprolol|"2 x 90 mg of ticagrelor will be administered orally to the subjects. Two hours after administration, the registrations and blood sampling are repeated after which an infusion of epinephrine diluted in glucose solution (5%) is started at a weight-adjusted rate of 0.01, 0.05, 0.10 and 0.15 μg kg-1 min-1. Each infusion will be maintained for 15 minutes.
~After the measurement at the highest dose of epinephrine, 5 mg metoprolol (Abcur, Haelsingborg , Sweden) will be given intravenously to the study subject and thereafter registrations and blood sampling will be repeated."
15927166|NCT03441399|Other|Financial incentives|Providing money for taking antidepressant medication
15927167|NCT03441386|Behavioral|Physical Exercise Session|
15927168|NCT03441373|Drug|XC8 20 mg|once daily during 5 days.
15927169|NCT03441373|Drug|XC8 100 mg|once daily during 5 days.
15927170|NCT03441373|Drug|XC8 200 mg|once daily during 5 days.
15927171|NCT03441373|Drug|Placebo|once daily during 5 days.
15927173|NCT03441347|Behavioral|Specific rehabilitation program|17-week specific and personalised rehabilitation program. The program starts with a visit to the Plexus out patient clinic in week 1. During this visit, the patient will be examined by a multidisciplinary team, consisting of a rehabilitation physician, neurologist, physical therapist and occupational therapist, which will form a rehabilitation treatment plan. This treatment plan is implemented through 4 weekly sessions in week 2-5, 2 biweekly sessions in week 6-9 and 2 monthly sessions in week 10-17 . Each treatment session involves one hour of physical- and one hour of occupational therapy.
15927174|NCT03441347|Other|Usual Care|Participants will receive their usual care for 17 weeks, which may vary for each individual
15927175|NCT03441334|Device|High Frequency rTMS|Participants in the intervention group will receive 1200 stimuli at the intensity of 90% of resting motor threshold via an air-filmed coil placed on the vertex. The stimulation will be delivered across 24 sessions (in 10 weeks). Right after each session, participants will receive a 45-minute structured body weight supported treadmill training.
15927176|NCT03441334|Device|Sham rTMS|Participants in the sham group will receive the same duration of stimulation via a sham coil placed on the vertex.Right after each session, participants will receive a 45-minute structured body weight supported treadmill training.
15927177|NCT03441321|Other|Media Intervention|Participate in Facebook group focusing on avoiding indoor tanning and promoting healthy body image
15927178|NCT03441321|Other|Media Intervention|Participate in Facebook group focusing on other health topics
15927179|NCT03441321|Other|Survey Administration|Ancillary studies
15927180|NCT03441308|Behavioral|Educational method of group treatment|
15927181|NCT03441295|Procedure|Dynamic Intraligamentary Stabilization|DIS, Ligamys
15927182|NCT03441295|Procedure|Internal Brace Ligament Augmentation|IBLA
15927183|NCT03441295|Procedure|ACL Reconstruction|Conventional
15927353|NCT03439969|Device|Mobile Text Messages|Dental inter-proximal control with floss holder and receiving 16 SMS during 4 months.
15927762|NCT03436732|Drug|SEL-110|administered on day 1 of each cycle for up to 4 cycles
15927184|NCT03441282|Drug|Fentanyl|"After the patient is attached to an ASA non-invasive monitor, a dose (2mcg/kg) of Fentanyl will be administered.
~Groups compared would include patients experiencing respiratory depression vs those not experiencing respiratory depression after fentanyl administration. Their samples would be evaluated for any differences in genetic make-up concerning selected, known sequences affecting opioid-induced analgesia."
15927185|NCT03441269|Drug|Oral Ibuprofen|Oral Ibuprofen will be given to all the arms; only the dosage will be different: 400mg vs. 600mg vs. 800mg
15927186|NCT03441256|Device|LION procedure|Laparoscopic implantation of an impulse generator and four leads for electrical stimulation of femoral and sciatic nerves.
15927187|NCT03441256|Device|NMES|Conventional neuromuscular electrical stimulation via surface electrodes.
15927188|NCT03441230|Device|Balloon characteristics|Different size balloon
15927189|NCT03441217|Drug|Hyoscine Butylbromide 20Mg/1mL Injection|Nulliparous women with gestations at term receive 20 mg of Hyoscine butylbromide upon arrival in the Labor and Delivery Unit (4-5 cms).
15927190|NCT03441217|Drug|Saline Solution|Nulliparous women with gestations at term receive 20 mg of saline solution upon arrival in the Labor and Delivery Unit (4-5 cms).
15927191|NCT03441204|Drug|LTOT 24 h/day|LTOT prescribed for 24 h/day.
15927192|NCT03441204|Drug|LTOT 15h/day|: LTOT prescribed for 15 h/day. The patient is instructed to use LTOT during sleep and not to use LTOT for about 9 hours during daytime, totalling 15 h/day.
15927193|NCT03441191|Device|Audiovisual Stimulation|A commercially available AVS device (MindPlace Procyon) modified for use in the current study will be used to deliver the AVS programs in this study
15927194|NCT03441178|Device|ENSEAL X1|ENSEAL X1 is used for transecting and sealing vessels according to instructions for use.
15927195|NCT03441165|Procedure|ligament reconstruction and meniscus transplantation|ACL reconstruction ACL revision MAT
15927196|NCT03441152|Device|tDCS|Transcranial direct current stimulation
15927199|NCT03441126|Other|Multicenter Quality Improvement program|Participating institutions will not participate in an intervention study. Sites will design and implement local QI programs to improve care within their unit. Local healthcare teams, who are interested in directly and immediately improving patient outcomes, will devise customized tools. The Bright STAR Team will assess the impact of these local QI initiatives on patient health outcomes, using data that are collected as part of the QI programs or through routine clinical care.
15927201|NCT03441100|Drug|IMA202 Product|The cell dose will be based on viable CD3+CD8+ HLA-Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula.
15927202|NCT03441100|Device|IMADetect®|IMADetect® is developed as a companion diagnostic to aid in selecting patients with relapsed and/or refractory solid cancers who might be eligible for enrollment in clinical trials. IMADetect® is intended for investigational use only.
15927203|NCT03441087|Device|Transvaginal ultrasound|
15927204|NCT03441087|Device|Hysteroscopy|
15927205|NCT03441074|Behavioral|enhanced olfactory stimuli|Patients in intervention group will get enhanced olfactory stimuli during perioperative period (7 days before and after the surgery), by using portable scented sachets.
15927206|NCT03441061|Biological|Inotuzumab Ozogamicin|Given IV
15927207|NCT03441048|Biological|Lintuzumab-Ac-225 (Dose 1: 0.25 μCi/kg Ac-225 with 1.6 μg/kg lintuzumab)|Lintuzumab-Ac225 is an immunoconjugate [antibody: anti-CD 33 antibody and radioactive isotope: Actinium (225Ac)] for the treatment of relapsed/refractory acute myeloid leukemia. Lintuzumab-Ac225 will be administered as a single dose on day 8 of therapy.
15927208|NCT03441048|Drug|Cladribine|Cladribine 5mg/m^2/day IV over two hours on days 2-6.
15927209|NCT03441048|Drug|Cytarabine|Cytarabine 2 gm/m^2/day IV over four hours on days 2-6.
15927210|NCT03441048|Drug|Mitoxantrone|Mitoxantrone 10mg/m^2/day IV on days 2-4.
15927211|NCT03441048|Drug|G-CSF|G-CSF at a dose of 300 µg on days 1-6.
15927212|NCT03441048|Biological|Lintuzumab-Ac-225 (Dose 2: 0.50 μCi/kg Ac-225 with 3.2 μg/kg lintuzumab)|Lintuzumab-Ac225 is an immunoconjugate [antibody: anti-CD 33 antibody and radioactive isotope: Actinium (225Ac)] for the treatment of relapsed/refractory acute myeloid leukemia. Lintuzumab-Ac225 will be administered as a single dose on day 8 of therapy.
15927213|NCT03441048|Biological|Lintuzumab-Ac-225 (Dose 3: 0.75 μCi/kg with 4.7μg/kg lintuzumab)|Lintuzumab-Ac225 is an immunoconjugate [antibody: anti-CD 33 antibody and radioactive isotope: Actinium (225Ac)] for the treatment of relapsed/refractory acute myeloid leukemia. Lintuzumab-Ac225 will be administered as a single dose on day 8 of therapy.
15927214|NCT03441048|Biological|Lintuzumab-Ac-225 (Dose 4: 1.00 μCi/kg with 6.4 μg/kg lintuzumab)|Lintuzumab-Ac225 is an immunoconjugate [antibody: anti-CD 33 antibody and radioactive isotope: Actinium (225Ac)] for the treatment of relapsed/refractory acute myeloid leukemia. Lintuzumab-Ac225 will be administered as a single dose on day 8 of therapy.
15927215|NCT03441048|Biological|Lintuzumab-Ac-225 (Dose 5: 1.25 μCi/kg with 8.0 μg/kg lintuzumab)|Lintuzumab-Ac225 is an immunoconjugate [antibody: anti-CD 33 antibody and radioactive isotope: Actinium (225Ac)] for the treatment of relapsed/refractory acute myeloid leukemia. Lintuzumab-Ac225 will be administered as a single dose on day 8 of therapy.
15927216|NCT03441035|Other|General anesthesia and surgery (liver transplantation)|The effects of general anesthesia and surgery under the hospital routine of albumin administration during and after liver transplantation is studied with the mass balance of albumin method.
15927217|NCT03441022|Device|Amiigo Watch Only|Subjects will be asked to wear a wrist band with capabilities to detect their heart rate or rhythm on the basis of PPG on either wrist around the time of their cardioversion procedure. Data will be acquired from the wrist band at the same time as the electrocardiogram (ECG) monitor to which subjects are hooked up for the purposes of the cardioversion.
15927432|NCT03439345|Drug|Fenofibrate 145 mg|One tablet (taken daily with normal renal function, taken every second day with chronic kidney disease)
15927218|NCT03441022|Device|Amiigo Watch + BodyGuardian|Subjects will be sent home after the cardioversion with a 30 day heart monitor called the BodyGuardian. This device continuously monitors their heart rate and rhythm and they will wear this on the chest. Subjects will also wear the wrist monitor over the same 30 day period.
15927219|NCT03441009|Other|Physio-/occupational therapy|Physio-/occupational therapy, ADL
15927220|NCT03440996|Other|Clinpro™ 5000|Clinpro™ 5000 with 1.1% Sodium Fluoride is a new anti-cavity toothpaste, and is currently available and have been shown in some initial case reports to be useful in the reduction of white spot lesions. Clinpro™ restores minerals and helps you produce saliva. The Clinpro™ products are advanced formulas containing an innovative tri-calcium phosphate ingredient. It is available exclusively from 3M ESPE. Clinpro™ contains fluoride as well as calcium and phosphate, which are components naturally found in saliva.
15927221|NCT03440996|Other|Clinpro™ Tooth Crème|Clinpro™ Tooth Crème with 0.21% Sodium Fluoride is a new anti-cavity toothpaste, and is currently available and have been shown in some initial case reports to be useful in the reduction of white spot lesions. Clinpro™ restores minerals and helps you produce saliva. The Clinpro™ products are advanced formulas containing an innovative tri-calcium phosphate ingredient. It is available exclusively from 3M ESPE. Clinpro™ contains fluoride as well as calcium and phosphate, which are components naturally found in saliva.
15927222|NCT03440996|Other|MI-Paste Plus|MI-Paste Plus is a widely used anti-cavity toothpaste on the market and it is used as a control group in this study.
15927223|NCT03440983|Device|MRI data acquiring in healthy volunteers|The quality of the images, cartographies or spectres will be compared to standard acquisitions. This evaluation will be based on qualitative visual criteria assessed by expert radiologists or on quantitative criteria assessed by data processing tools
15927224|NCT03440970|Drug|Lysine Chloride|Patients will receive the study drug twice a day for 5 days.
15927225|NCT03440970|Other|Placebo|Patients will receive the placebo twice a day for 5 days.
15927226|NCT03440957|Other|Osteopathic treatment|The patients meeting the inclusions criteria will be informed of the study and an osteopathic treatment holistic ,involving all the body will be applied, three time with 2 days between the treatments .Each meeting with the practitioner will last around 40 minutes. The pain and symptoms assessment will be done before and after the treatment .
15927227|NCT03440944|Device|Ultrasound Guided Peripheral IV Catheter|Patients randomized to this arm will receive an ultrasound guided peripheral IV catheter.
15927228|NCT03440944|Device|Midline Catheter|Patients randomized to this group will receive a midline catheter. The catheter is 10cm in length.
15927229|NCT03440931|Diagnostic Test|Ultrasound scan|Transvaginal ultrasound scan to assess ovaries
15927230|NCT03440918|Other|Procalcitonin-Guided Antimicrobial Stewardship|In addition to baseline audit of antimicrobial orders, the stewardship team will additionally recommend procalcitonin (PCT) testing and treatment per algorithm. PCT will be used in conjunction with clinical status and exam, and results of radiographic and laboratory studies, to make medical decisions about antibiotic therapy.
15927231|NCT03440918|Other|Baseline Antimicrobial Stewardship|Baseline audit of antimicrobial orders with feedback to providers by the antimicrobial stewardship team.
15927232|NCT03440892|Drug|methotrexate|folate antagonist
15927233|NCT03440892|Drug|sulfasalazine|Immunomodulatory
15927234|NCT03440892|Drug|abatacept|Targeting CTLA-4 (fusion protein composed of the Fc region of the immunoglobulin IgG1 fused to the extracellular domain of CTLA-4)
15927235|NCT03440892|Drug|tocilizumab|IL-6 receptor antagonist
15927236|NCT03440892|Drug|tofacitinib/baricitinib|JAK inhibitor
15927237|NCT03440879|Drug|Zoladex|Patients currently treated with Zoladex
15927238|NCT03440866|Drug|Administration of drugs concomitantly.|Administration of oral Mifepristone 600 mg and oral Misoprostol 400 mcg concomitantly.
15927239|NCT03440853|Behavioral|TASCCI|TASCCI is a stepped-care collaborative care approach of pharmaco- and/or behavioral-therapy for a 12 week period. The intervention will target 1 or more symptoms based on patients' report of clinical levels of each symptom and patient preference. A trained behavioral therapist will deliver weekly video conferencing sessions during dialysis treatment.
15927240|NCT03440853|Other|Technology Delivered Health Education Intervention|The Technology Delivered Health Education Intervention will deliver weekly video conferencing sessions to deliver online educational material from the National Kidney Foundation. These sessions will be delivered by a care coordinator.
15927241|NCT03440840|Procedure|Transcranial Direct Current Stimulation (tDCS)|Application of a small electrical current (1-2 mA) across the head.
15927242|NCT03440840|Behavioral|Computer-based Cognitive Training|Use of computer-delivered games or exercises with the goal of improving cognitive performance.
15927243|NCT03440840|Behavioral|Watching Educational Videos|Watching educational videos and answering questions about them
15927244|NCT03440827|Behavioral|Focus Group|First (phase 1), collect experiences, perceptions, difficulties, needs and expectations of patients with slow-flow malformations (for the age group of 11 to 15 years-old), carried out with 3 categories of participants and then (phase 2) development and validation of the specific scale of life's quality of slow-flow vascular malformation in children aged 11 to 15 years-old.
15927245|NCT03440814|Drug|DCCR|Once daily oral administration
15927246|NCT03440814|Drug|Placebo for DCCR|Once daily oral administration
15927247|NCT03440801|Device|Synergy|Biodegradable-polymer everolimus-eluting stent Synergy
15927248|NCT03440801|Device|Xience|Durable-polymer everolimus-eluting stent Xience
15927249|NCT03440788|Drug|Brentuximab Vedotin|Brentuximab vedotin (BV) will be prescribed to patients in accordance with indication for treatment as second or subsequent line therapy after failure of at least one type of first-line therapy for patients with relapsed or refractory HL who are not candidates for ASCT, or for patients with relapse after ASCT within routine hematological practice. Dose, preparation, administration etc - as in Instruction for use (Prescribing information).
15927250|NCT03440775|Behavioral|Digital stories|Digital story telling videos
15927251|NCT03440775|Behavioral|Informational videos|Informational videos
15927252|NCT03440762|Behavioral|AF awareness education|Participants will receive education about a description of AF, complications, recognition of signs and symptoms of AF, pulse taking, and how to recognize an irregular pulse
15927433|NCT03439345|Drug|Placebo Oral Tablet|One tablet (taken daily with normal renal function, taken every second day with chronic kidney disease)
15927253|NCT03440749|Other|luminous stimuli|The child is placed in front of a screen on which 4 luminous stimuli are presented on a horizontal plane. Four buzzers are placed in front of him, each buzzer corresponds to the position of a stimulus. Child had to push the buzzer corresponding to the place of the luminous stimuli.
15927254|NCT03440736|Drug|Secukinumab|Secukinumab 300 mg s.c., which consists of two injections with 150 mg prefilled syringes at weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24 (last injection is performed at week 24)
15927255|NCT03440736|Behavioral|Life-style intervention|A structured program to guide weight loss and increased physical activity
15927256|NCT03440723|Device|DilaCheck|Measuring device for the measurement of cervical dilation
15927257|NCT03440723|Diagnostic Test|Cervical dilation examination|Sterile vaginal examination using subjective methods for measurement of cervical dilation
15927258|NCT03440710|Procedure|BET|Balloon Eustachian Tuboplasty
15927259|NCT03440684|Other|Exercise|"At the beginning of the training, participants were informed about the anatomy and biomechanics of core muscles and the effectiveness core stabilization exercises.
~In all sessions, 5 minutes warm-up exercises and 5 minutes cool-down exercises were done before training. The exercises were first shown by the physiotherapist 2 to 3 repetitions and then the participants performed the exercise 10 to 12 repetitions.
~Participants were included clinical pilates exercises for 6 weeks, which would be 3 days per week. Exercise programme were managed by one and the same physiotherapist. Each week the level of difficulty of the exercises was increased according to the tolerance of the participants and new exercises were added to the program."
15927260|NCT03440671|Biological|Hutox Inj|Hutox Inj(Clostridium botulinum type A)
15927261|NCT03440671|Biological|Botox Inj|Botox Inj(Clostridium botulinum type A)
15927262|NCT03440645|Other|Family-oriented primary cardiovascular prevention|An initial screening visit including a targeted history, physical exam, and investigations as per the Canadian Cardiovascular Society's recommendations for cardiovascular primary prevention. Counselling and informational handouts on improved cardiovascular risk factor and lifestyle habits. All family and household members, as well as the cardiovascular disease proband, are encouraged to attend and participate in all healthcare visits.
15927263|NCT03440632|Device|FES|Functional electrical stimulation of the ankle dorsiflexors during walking, using a (superficial) neurostimulator with tilt sensor.
15927264|NCT03440619|Device|INVSENSOR00013|Investigational pulse oximeter device that will be placed on the subject's finger. This will be used as a spotcheck device
15927265|NCT03440606|Behavioral|Mindful-Compassion Art Therapy Supervision|"Each Mindful-Compassion Art Therapy Supervision group will focus on 3 major areas that cultivate self-care, resilience and communal support. The specific structure include: (1) Self-care and Stress Management in Week 1 and 2 (i.e., concept of mindfulness and art, the symbol of the mandala and its use in self-care, mindfulness practice and art); (2) Sharing of Clinical Expertise and Experiences in Week 3 and 4 (i.e., Create mindful art about one meaningful and one challenging patient/client interaction with small group discussion); and (3) Understanding Grief and Meaning-Making in Week 5 and 6 (i.e., Create mindful art representing a clinical encounter of mortality, and meaning-making from reflection on grief)."
15927266|NCT03440593|Other|Caloric delivery will target results of IC measurement.|The prescribed calories to be delivered will be set to target the measurement obtained from performing indirect calorimetry (IC). IC measures the gas exchange of oxygen consumption and carbon dioxide production to determine the true metabolic needs for cellular respiration. The expenditure of calories will be measured utilizing the gas module incorporated within the General Electric Carescape R860 ventilators.
15927267|NCT03440580|Device|BOOSTH|BOOSTH as a serious game is used as a tool to motivate children to perform more PA. BOOSTH uses the combination of a smartphone game and a pedometer that assesses daily PA by measuring steps/day. The BOOSTH activity monitor is a wrist-worn activity monitor that is able to provide online feedback on the child's PA levels. Moreover, BOOSTH is a reward-based game as a child is given incentive to increase their PA level, in order to acquire activity points which later can be used to unlock levels and progress in the BOOSTH game.
15927268|NCT03440567|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo autologous hematopoietic stem cell transplantation
15927269|NCT03440567|Drug|Avelumab|Given IV
15927270|NCT03440567|Drug|Carboplatin|Given IV
15927271|NCT03440567|Drug|Etoposide Phosphate|Given IV
15927272|NCT03440567|Drug|Ibrutinib|Given PO
15927273|NCT03440567|Drug|Ifosfamide|Given IV
15927274|NCT03440567|Other|Laboratory Biomarker Analysis|Correlative studies
15927275|NCT03440567|Biological|Rituximab|Given IV
15927276|NCT03440567|Biological|Utomilumab|Given IV
15927277|NCT03440554|Diagnostic Test|Whole Body Non-Contrast MRI|Whole Body Non-Contrast MRI in Prostate Cancer Patients
15927278|NCT03440541|Combination Product|REGE pro|REGE pro is a patch of human amniotic membrane sterilized by gamma radiation
15927279|NCT03440515|Drug|Prednisone|Prednisone treatment for severe skin rash induced by imatinib
15927280|NCT03440502|Procedure|spinal anaesthesia|Intrathecal block under strict aseptic conditions will be performed by median approach (L3-4 or L4-5) under sitting position by anesthesiologists . 25 Gauge sprotte spinal needles and 2-3 mLof 0.5% hyperbaric bupivacaine
15927281|NCT03440489|Diagnostic Test|Six-minute walking test|physical performance of the muscle measured by these tests
15927282|NCT03440489|Diagnostic Test|30 seconds chair stand test|physical performance of the muscle measured by these tests
15927283|NCT03440476|Behavioral|e-checkup to go|The e-checkup to go substance program is designed to motivate individuals to reduce their consumption using personalized information about their own use and risk factors. The program is a combination of several components including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It is self-guided and requires no face-to-face time with an administrator. It provides tailored feedback regarding quantity and frequency of alcohol use, normative comparisons, physical health information, amount and percent of income spent on alcohol, negative consequences feedback, explanation and advice for how to reach their goals, and resources.
15927284|NCT03440476|Behavioral|Feedback-only booster|Booster emails will contain normative feedback indicating average consumption for students at the same institution by sex, their perceptions of student drinkers at the same institution, their own reported consumption, and reminders of strategies they can use to protect themselves from alcohol-related harm. The content is clearly automatically generated.
15927285|NCT03440476|Behavioral|Feedback-plus-personal-contact booster|Booster emails will contain normative feedback indicating average consumption for students at the same institution by sex, their perceptions of student drinkers at the same institution, their own reported consumption, and reminders of strategies they can use to protect themselves from alcohol-related harm. The email is sent from an individual on the research staff.
15927286|NCT03440463|Behavioral|e-checkup to go|The e-checkup to go substance program is designed to motivate individuals to reduce their consumption using personalized information about their own use and risk factors. The program is a combination of several components including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It is self-guided and requires no face-to-face time with an administrator. It provides tailored feedback regarding quantity and frequency of alcohol use, normative comparisons, physical health information, amount and percent of income spent on alcohol, negative consequences feedback, explanation and advice for how to reach their goals, and resources.
15927287|NCT03440463|Behavioral|Norms-only booster|Booster emails will contain normative feedback indicating average consumption for students at the same institution by sex, their perceptions of student drinkers at the same institution, their own reported consumption, and how they compare.
15927288|NCT03440463|Behavioral|Norms-plus-Strategies booster|Booster emails will contain normative feedback indicating average consumption for students at the same institution by sex, their perceptions of student drinkers at the same institution, their own reported consumption, and how they compare. These booster emails will also contain reminders of strategies they can use to protect themselves from alcohol-related harm, both ones they've reported using in the past and others they might consider using in the future.
15927289|NCT03440450|Drug|FF-10832 Gemcitabine Liposome Injection|FF-10832 to be diluted in dextrose 5% in water (D5W) and intravenously infused at a continuous rate over 30 to 120 minutes
15927291|NCT03440424|Drug|Lemborexant|oral tablet
15927292|NCT03440411|Drug|Pomalidomide|4 mg/daily as oral administration (PO) on days 1-21.
15927293|NCT03440411|Drug|Cyclophosphamide|50 mg every other day as oral administration (PO) on days 1-28
15927294|NCT03440411|Drug|Dexamethasone|40 mg as oral administration (PO) on days 1, 8, 15, 22.
15927295|NCT03440398|Procedure|Robotic NSM|Surgical technique conducted using robot to perform nipple sparing mastectomy and breast reconstruction
15927296|NCT03440398|Procedure|Open NSM|Open nipple-sparing mastectomy and immediate breast reconstruction with implant
15927297|NCT03440385|Drug|Ozanimod|Ozanimod
15927298|NCT03440385|Other|Placebo|Placebo
15927299|NCT03440372|Drug|Ozanimod|Ozanimod
15927300|NCT03440372|Other|Placebo|Placebo
15927301|NCT03440359|Drug|Progesterone Vaginal Gel 8%|progesterone supplementation for luteal phase support administered with vaginal applicators and used instead of progesterone intramuscular injections or progesterone vaginal suppositories.
15927302|NCT03440359|Drug|Letrozole Oral Tablet|letrozole oral tablet 2.5 mg or 5 mg administered cycle day 3-7 for ovulation induction
15927303|NCT03440359|Diagnostic Test|pelvic ultrasound|pelvic ultrasound performed at cycle day 11 or 12 and repeated as necessary until leading follicle size is >17 mm in diameter
15927304|NCT03440359|Drug|Ovidrel 250 MCG Per 0.5 ML Prefilled Syringe|ovidrel 250 mcg given when leading follicle size is > 17 mm in diameter
15927305|NCT03440359|Other|Intrauterine insemination or timed intercourse|Intrauterine insemination or timed intercourse (depending on semen parameters) performed 36-40 hours after Ovidrel
15927306|NCT03440346|Other|Few-foods diet|The few-foods diet (FFD) is followed for 5-weeks preceded by a 1-week transition period during which the child's eating pattern will be gradually adjusted. The diet consists of rice, meat (turkey and lamb), a range of vegetables, pear, rice milk with added calcium and water, and is complemented with foods such as potatoes, fruits, corn, some sweets and wheat, which are allowed in small quantities only. Normal quantities of vegetables, rice and meat are allowed every day. If necessary the diet will be adjusted to avoid foods that the child dislikes or has cravings for. If the child does not respond to the initial FFD, i.e. no change in behaviour after the first two weeks, interim adjustments to the FFD will be made in consultation with the parents.
15927307|NCT03440333|Drug|surfactant|Pulmonary surfactant was administrated if the baby was diagnosed with respiratory distress syndrome
15927308|NCT03440320|Behavioral|MY-SKILLS - online|Participants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of yoga and an hour of self-management designed to meet the needs of a caregiving dyad with chronic pain
15927309|NCT03440320|Behavioral|MY-Plan control - online|Participants will complete an 8-week, 16 session class. Each class will consist of approximately an hour of exercise and an hour of education designed to meet the needs of a caregiving dyad with chronic pain..
15927310|NCT03440307|Behavioral|Face-to-Face Meetings|Participants received health and fitness education, and a face-to-face 3-week intervention to reduce bisphenol exposure.
15927311|NCT03440307|Behavioral|Email Only|Participants received health and fitness education.
15927312|NCT03440294|Diagnostic Test|resting standard spirometry|The subject (seated, bust straightened) should perform, after a slow and maximum inspiration, a forced and complete exhalation followed by a new inspiration to the total lung capacity.
15927313|NCT03440294|Diagnostic Test|maximum exercise testing|Incremental exercise on cycle ergometer with 100W start for men (80W for women) for 4 minutes as part of the warm-up. Then, step increment of a 50W power for men (40W for women) lasting 2 minutes each.
15927314|NCT03440281|Diagnostic Test|Uterine artery doppler|Uterine artery Doppler pulsatility indices
15927315|NCT03440281|Diagnostic Test|Maternal serum homocysteine estimation|
15927316|NCT03440268|Drug|N Acetyl Cysteine|Administrate NAC in the pre operatory and intra operatory moments and assess the influence in the outcomes
15927317|NCT03440268|Drug|Placebos|These participants will receive a saline solution in pre operatory with the same volume as the experimental group, and this solution will be administrated in 2 hours. During the surgery they will receive a new solution with the same volume of the experimental group, and this solution will be administrated in 6 hours too. The solutions will be covered by an opaque bag, so the participant will not see what is being administrated
15960803|NCT03182426|Drug|Liraglutide|Beta-cell regeneration
15927318|NCT03440255|Device|Transcutaneous Vagus Nerve Stimulation|"TaVNS will be applied by the TENS 7000 device. The stimulation was set according the group of treatment: (GAD: 20Hz-80µs), (CP: 5Hz-200 µs), (IBS: 3Hz-250µs).
~The current intensity was individually established under the pain threshold .The stimulus generates an continous asymmetric biphasic waveform. Ear clip electrodes were plugged in the concha area of the left ear. The stimulation will last 30 min per session (total=8)"
15927319|NCT03440242|Device|JJVC Contact Lens|etafilcon A with PVP DD
15927320|NCT03440242|Device|Marketed Contact Lens|nelfilcon A DD
15927322|NCT03440216|Drug|blood sampling|"temocillin: blood sampling every day for 7 days
~ceftriaxone: blood sampling 12h after administration for 7 days
~meropenem: blood sampling at 1h, 3h, 5h and 8h after initiation of the administration at days 1 and 2; one sampling at 8h on days 3 to 7"
15927323|NCT03440216|Drug|Tissue sampling (lung)|Sampling of tissue (lung) when possible during treatment for measurement of the content in antibiotic (temocillin, ceftriaxone, or meropenem, depending on the drug received by the patient)
15927324|NCT03440216|Drug|Collection of fluid samples|Collection of fluid samples (bronchoalveolar lavage, drainage fluid) for determination of antibiotic ((temocillin, ceftriaxone, or meropenem, depending on the drug received by the patient) concentration when possible during treatment
15927325|NCT03440203|Other|difficult activities of daily living in each group|Compare the severity of pain by the severity of diabetic peripheral neuropathy. Compare the difficulties in ADLs in three group of diabetic patients
15927326|NCT03440190|Drug|Methylphenidate|Patients are tested for their normal prescription methylphenidate medication
15927327|NCT03440177|Drug|Ramipril|Patients are tested for their normal prescription ramipril medication
15927328|NCT03440164|Other|Sylimarin and Sylibin|We compared the plasma levels of Silibinin after a dosage of Silibinin-phosphatidylcholine complex, equivalent to 45 mg Silybin oily-medium soft-gel capsules after the conventional 70-mg Silymarin tablets, in 23 healthy volunteers
15927329|NCT03440151|Procedure|contralateral submental flap for tongue cancer defect|"Tumor resection will be star first this accomplish with 1- 2 cm safety margin, Simultaneous neck dissection will be performed in all patient.
~Flap dissection begins from the opposite side of the pedicle in the subplatysmal plane. Then the level 1a is dissected, the distal facial artery and facial vein to the branching point of the submental pedicle are ligated. The anterior belly of the digastric muscle on ipsilateral to the pedicle and strip of mylohyoid muscle will dissected off the mandible and the hyoid bone and included with the flap. This results in complete mobilization of the flap.A tunnel will be created between the defect and the donor site and the skin paddle of the flap will be transported through it intraorally and the flap is insetted."
15927330|NCT03440151|Procedure|primary closure for tongue cancer defect|Under general anesthesia the tumor will be resected with Preserving floor of mouth mucosa as much as possible to avoid restriction of tongue mobility. After Obtaining meticulous hemostasis, the tongue defect will be closed in layers.
15927331|NCT03440138|Procedure|bariatric surgery (RYGB or SG)|laparoscopic Roux-en-Y gastric bypass or sleeve gastrectomy for severe obesity
15927332|NCT03440125|Drug|Cayenne Pepper topical|20min topical Cayenne Pepper Cataplasm application containing 5% Cayenne Pepper nd 95% Kaolin mixed with water
15927333|NCT03440125|Device|Electrical stimulation|Electrical stimulation 10min 60Hz biphasic rectangular neuromuscular electrical Stimulation (NMES)
15927334|NCT03440125|Procedure|Massage|10 minutes of classical massage of low back pain area.
15927335|NCT03440112|Drug|Clarithromycin (Not used as of 4/2020)|Clarithromycin (generic) capsule 250mg each
15927336|NCT03440112|Drug|Placebo (Not used as of 4/2020)|Lactose in a gel capsule
15927337|NCT03440112|Drug|Transdermal flumazenil (Added 4/2020)|Transdermal flumazenil 24mg/mL
15927338|NCT03440112|Drug|Placebo (Added 4/2020)|Transdermal placebo
15927339|NCT03440099|Other|Resistance exercise training|16-week exercise training program, wherein one leg undergoes traditional low-velocity, high-load resistance training and the other leg undergoes high-velocity, low-load power training.
15927340|NCT03440086|Device|abdominal Jackson-Pratt drain|One-hour application of abdominal Jackson-Pratt drain at the end of laparoscopic procedure.
15927341|NCT03440073|Other|Mulligan Concept Intervention|The concept is a manual therapy paradigm that includes a clinician applying joint mobilizations and having the patient perform concurrent active, pain free, movement.
15927342|NCT03440073|Other|Sham Mulligan Concept Treatment|The treating clinician will ask the participant to perform the movements associated with the Mulligan Concept technique. The clinician will have her hands on the participant during the movement but will not apply any pressure or force.
15927343|NCT03440060|Diagnostic Test|procalcitonin|procalcitonin value will be obtained within 24 hours after ICU admission in both groups and will be taken into account in the procalcitonin group only
15927345|NCT03440034|Drug|Pioglitazone|Pioglitazone comes as a tablet to take by mouth and can be taken with or without food.
15927346|NCT03440021|Drug|ORM-12741|Novel selective alpha2c adrenoceptor antagonist
15927347|NCT03440021|Drug|Placebo|Identical in appearance to experimental drug, not psycho-active
15927348|NCT03440008|Other|Dynamic 3D bone motion capture|Two x-ray systems will image the subjects ankle while they walk, allowing us to calculate ankle joint angle and alignment
15927349|NCT03440008|Device|wedged insole|medial or lateral wedge (appropriate for varus or valgus misalignment) will be applied during 1 data collection session to evaluate effect of wedging on misalignment
15927350|NCT03439995|Other|Open lung protective ventilation|Higher PEEP, lower tidal volume mechanical ventilation
15960804|NCT03182413|Drug|Placebo|
15960805|NCT03182413|Drug|Modafinil|
15927354|NCT03439969|Device|Intra Oral Camera|"SPT - Appointment with Intra-Oral Camera
~Examination and diagnosis (15 min) using Intra-oral camera.
~Motivation, discussion about desired outcomes and treatment needs (using Intra-oral camera) followed by instrumentation (scaling, polishing) (30 min)."
15927355|NCT03439956|Procedure|Transvaginal specimen extraction|Previous transvaginal specimen extraction through posterior colpotomy.
15927356|NCT03439943|Drug|Lixisenatide|Patients randomized in the Lixisenatide group will receive 10μg/day for 14 days and then 20μg/day administered by once-daily subcutaneous injections during 12 months. If patients are unable to tolerable the dose of 20μg/day, this dose can be reduced to 10μg/day
15927357|NCT03439943|Drug|placebo|Patients randomized in the placebo group will receive the corresponding placebo administered subcutaneously (once daily subcutaneous injection).
15927358|NCT03439930|Other|Balance training|6 weeks lasting balance training program
15927359|NCT03439917|Dietary Supplement|L-Carnitine tartrate|2g L-Carnitine tartrate as a powder consumed twice a day
15927360|NCT03439917|Dietary Supplement|Meal Replacement Drink|325ml dairy-based meal replacement drink ('Slimfast' trademark of KSF Acquisition UK Ltd) consumed twice a day
15927361|NCT03439917|Dietary Supplement|Maltodextrin|2g Maltodextrin powder packaged to mimic carnitine powder consumed twice a day
15927362|NCT03439904|Other|Pharmaceutical care|Patients receive pharmaceutical care including individualized evaluation and intervention of adherence, efficacy and safety in cancer pain treatment.
15927363|NCT03439891|Biological|Nivolumab|Given IV
15927364|NCT03439891|Drug|Sorafenib|Given PO
15927365|NCT03439878|Dietary Supplement|Galactose|Co-ingestion of d-galactose with a high-fat meal
15927366|NCT03439878|Dietary Supplement|Glucose|Co-ingestion of d-glucose with a high-fat meal
15927367|NCT03439865|Drug|Ivacaftor|150 mg tablet PO BID x 14 days
15927368|NCT03439865|Drug|standard of care treatment|topical nasal steroid spray and culture-directed antibiotics x 14 days
15927369|NCT03439852|Behavioral|Light-to-Moderate Physical Activity / Sedentary Time|12 weeks of telephone counseling -motivational interviewing designed to increase leisure-time physical activity and decrease amount of sitting each day
15927370|NCT03439839|Drug|LNP023|LNP023 bid
15927371|NCT03439813|Behavioral|TASK-CBT|.Web and telephone-delivered cognitive behavioural therapy designed for anxiety after stroke and TIA. Six personalized telephone CBT sessions, one week apart by a trained and supervised medical professional using the TASK Therapist's Manual. Treatment website contains multimedia content to cover key CBT skills with weekly online tasks.
15927372|NCT03439813|Behavioral|TASK-Relax|Web and telephone-supported relaxation therapy. Treatment website contains five relaxation exercises: i) audio- and visually-guided breathing exercise, ii) relaxing imagery and sounds, iii) music for relaxation, iv) audio-guided progressive muscle relaxation, and v) a selection of sounds of nature. Telephone instruction given and treatment website contains multimedia content to explain to participant how to practice relaxation regularly during the trial period.
15927373|NCT03439800|Other|Mental and Physical Practice|"Subjects will see a video of the typical gait and will attempt to analyze the sequence of the gait cycle.
~They will imagine themselves walking in the first-person perspective (kinesthetic) using the gait of the non-pathological pattern during 2 minutes.
~From the 1st to 4th session, the subjects will perform gait with corrections identified in previously in the video for 2 minutes.
~From 5th to 8th session: the subjects will do the protocol already described, however, the imagined gait will be in an environment with obstacles, also for 2 minutes. They will continue with the physical practice of the gait with obstacles.
~From 9th to final training session: both mental and physical practice of the dual task gait."
15927374|NCT03439800|Other|Physical Practice|"Subjects will see a video about PD which does not mention physiotherapy treatments related to gait and they will explain their understanding about the theme.
~Then, the patients will make the physical gait protocol. Patients will be invited to perform the gait, in flat and firm ground with a length of 60 meters. The execution will be carried out for 10 minutes.
~From the 5th to 8th session, the subjects will do the physical practice of the gait with obstacles (which will be: going through 2 cones zigzag, going up and down 1 step, going through a narrow door, going up and down 1 ramp, going over 1 box of shoes, climbing a ramp, going down 1 step) for 2 minutes.
~From the 9th to the final training session, the subjects will do physical practice of the dual task gait."
15927375|NCT03439787|Drug|Bupivacaine-EPINEPHrine 0.5%-1:200,000 Injectable Solution|10 ml
15927376|NCT03439787|Other|Sodium Chloride 0.9 %|10 ml
15927377|NCT03439774|Device|Topcon CT-800|tonometer
15927378|NCT03439774|Device|Topcon TRK-2P|tonometer, pachymeter
15927379|NCT03439761|Drug|PT-112 Injection|PT-112 Injection 28 days constitute a period. The drug is intravenously dripped for 60 minutes at the 1st, 8th and 15th day of each period.
15927380|NCT03439748|Behavioral|Positive Affect Treatment|Sessions 1-7: Planning for engagement in pleasurable activities and reinforcement of positive mood effects of those activities Sessions 8-10: Exercises focusing on identifying positive aspects of experience, taking responsibility for positive outcomes, and imagining future positive events Sessions 11-14: Exercises to cultivate and savor positive experiences Session 15: Relapse prevention.
15927381|NCT03439748|Behavioral|Negative Affect Treatment|Sessions 1-7: Exposures to avoided scenarios Sessions 8-10: Cognitive restructuring Sessions 11-14: Normalization of arousal response to exposure Session 15: Relapse prevention
15927382|NCT03439735|Drug|Endocrine Therapy and a CDK 4/6 inhibitor|Participants with untreated metastatic disease receiving ET and a CDK 4/6 i as first line therapy.
15927383|NCT03439735|Drug|Endocrine Therapy and a CDK 4/6 inhibitor|Participants initiating a CDK 4/6 i after progression on ET.
15927384|NCT03439722|Other|Polysomnography|Participants will be admitted for 1 night at the Danish Center of Sleep Medicine for polysomnography.
15927385|NCT03439709|Radiation|Gamma knife radiosurgery|Minimum 25 Gy of marginal dose is applied for residual tumor or resection cavity. Depending on the size of tumor, the dose can be varied.
15927386|NCT03439709|Drug|Lanreotide 60Mg Solution for Injection|Lanreotide injection.
15927387|NCT03439696|Procedure|Thoracoscopic surgery|Video-assisted thoracoscopic surgery for pulmonary or mediastinal lesions.
15927434|NCT03439319|Device|MyndMove®|This FES therapy can be used as a short-term therapeutic intervention to help improve voluntary grasping function
15928250|NCT03433079|Diagnostic Test|Myoglobin|The level of myoglobin was assessed in all patients.
15927388|NCT03439683|Other|Survey about patient-ventilator asynchrony|Participants will fill an online survey that asks multiple-choice questions related to knowledge, attitudes and practice related to patient-ventilator asynchrony and also have images of ventilator waveforms wth asynchrony, where they need to identify the type of asynchrony
15927389|NCT03439670|Drug|Vamorolone|Oral administration of 2.0 mg/kg/day for the duration of the study.
15927390|NCT03439670|Drug|Prednisone|Oral administration of 0.75 mg/kg/day for 24 weeks.
15927391|NCT03439670|Other|Placebo|Oral administration of placebo daily for 24 weeks.
15927392|NCT03439670|Drug|Vamorolone|Oral administration of 6.0 mg/kg/day for the duration of the study.
15927393|NCT03439670|Drug|Prednisone|Oral administration of 0.75 mg/kg/day for 24 weeks.
15927394|NCT03439670|Other|Placebo|Oral administration of placebo daily for 24 weeks.
15927395|NCT03439670|Drug|Vamorolone|Oral administration of 2.0 mg/kg/day for 20 weeks.
15927396|NCT03439670|Drug|Vamorolone|Oral administration of 6.0 mg/kg/day for 20 weeks.
15927397|NCT03439657|Biological|HZ/su vaccine GSK1437173A|2 doses of 0.5 mL of the vaccine in a 0,2 Months schedule. Administered by intramuscular injection into the deltoid muscle of the non-dominant arm.
15927398|NCT03439657|Biological|Prevenar13|1 dose of 0.5 mL of the vaccine. Administered by intramuscular injection into the deltoid muscle of the dominant arm.
15927399|NCT03439644|Other|Measurement of the upper eyelid laxity|Measurement using a soft slider of the distance between our 2 marks The difference obtained between the measurement and the initial 10 millimeters corresponds to the tarsal laxity.
15927400|NCT03439631|Other|Patient satisfaction questionnaire|Patient satisfaction questionnaire
15927401|NCT03439618|Other|time-restricted feeding|At the beginning, all enrolled patients were fed by continuous feeding. When the amount calorie of feeding enteral nutritional suspension increased to 80% target calorie (target calorie: 25kilocalorie/kg.d), the patients was randomly into continuous feeding and time-restricted feeding group. In continuous feeding group, the enteral nutritional suspension was fed at constant speed for 24h.In the time restricted feeding, feeding time should be at 7:00-9:00, 11:00-13:00 and 17:00-19:00 at constant feeding speed.
15927402|NCT03439618|Other|continuous feeding|At the beginning, all enrolled patients were fed by continuous feeding. When the amount calorie of feeding enteral nutritional suspension increased to 80% target calorie (target calorie: 25kilocalorie/kg.d), the patients was randomly into continuous feeding and time-restricted feeding group.In the continuous feeding, the total amount of every days' Enteral Nutritional Suspension was fed at constant speed for 24h.
15927403|NCT03439592|Diagnostic Test|collection of fecal material|in study population we will collect fecal material to analyze the microbiotic flora by genetic techniques.
15927404|NCT03439579|Behavioral|Home weight loss program|Patient remote self-monitoring of diet, activity, and weight with clinician feedback provided remotely based on self-monitored data.
15927405|NCT03439553|Behavioral|Ads display with target websites|Ads are shown, but users are referred to control websites.
15927406|NCT03439553|Behavioral|Ads display with control websites|Ads are shown, but users are referred to control websites.
15927407|NCT03439540|Dietary Supplement|Plantago major|Individuals receive Plantago major daily, for 12 weeks
15927408|NCT03439540|Dietary Supplement|Placebo|Individuals receive placebo daily, for 12 weeks
15927409|NCT03439527|Other|Muscle Precursor Cells (MPCs), ATMP|The advanced therapeutic investigational product, the MPCs, is a living, autologous cell-product isolated from a biopsy of the patient's own musculus soleus.
15927410|NCT03439514|Drug|ARRY-371797 (PF-07265803)|400 mg twice daily (BID)
15927411|NCT03439514|Other|Placebo|BID
15927412|NCT03439501|Drug|avelumab|"Study drug: Avelumab (PD-L1 inhibitor; MSB0010718C)
~Dosage: 10 mg per body weight (kg) of a subject every two weeks
~One cycle consists of two injection of avelumab (28 days).
~The treatment cycle will be repeated until progression of disease or unacceptable toxicity and dose adjustments are permitted for patients who are unable to tolerate the side effects of drugs within each cycle."
15927413|NCT03439488|Drug|JNJ-440|JNJ-440 will be administered as oral tablets in Parts 1, 2 and 3. JNJ-440 may be provided as oral solution in a cohort in Part 1.
15927414|NCT03439488|Drug|Placebo|Matching placebo as oral tablets will be administered in Parts 1, 2 and 3.
15927415|NCT03439475|Biological|AMG 714|
15927416|NCT03439462|Drug|ABI-009; nab-rapamycin; albumin-bound rapamycin|albumin-bound rapamycin
15927417|NCT03439449|Device|CLEOS software program|Computer-assisted history taking program
15927418|NCT03439449|Procedure|Physician taken history|Conventional history taking by physicians
15927419|NCT03439436|Drug|xylo+dex nasal spray (0.1 mg+5 mg/dose)|Xylometazoline+Dexpanthenol metered nasal spray (0.1 mg+5 mg/dose) for nasal congestion. One spray into each nostril, 3 times daily for max 5 days.
15927420|NCT03439436|Drug|Nasic|Xylometazoline+Dexpanthenol metered nasal spray (0.1 mg+5 mg/dose) for nasal congestion. One spray into each nostril, 3 times daily for max 5 days.
15927421|NCT03439423|Radiation|CT with contrast agent|
15927422|NCT03439423|Diagnostic Test|MR without contrast agent|"on 1.5-T unit, with the following sequences:
~steady-state free-precession (true-FISP)
~half-Fourier single shot spin-echo (HASTE)"
15927423|NCT03439423|Diagnostic Test|Color-Doppler Ultrasound|
15927424|NCT03439423|Other|Questionnaire|regarding their perception of examinations
15927425|NCT03439410|Other|Clinical Complexity Index|Clinical Complexity Index (CCI) will be administered at the time of admission to the ward.
15927426|NCT03439397|Device|Ballon Technique|Ballon Technique
15927427|NCT03439397|Device|SOAI|SOAI
15927428|NCT03439384|Device|Home Telemonitoring|Patients will monitor their weight, blood pressure, oxygen saturation and symptoms with sensors and a tablet computer provided to them. Patients are asked to do this everyday for 60-days. A monitoring nurse will be receiving the data electronically and reviewing on a daily basis.
15927429|NCT03439371|Other|HLA-mismatched micro-transplantation after induction chemotherapy|HLA-mismatched micro-transplantation after induction chemotherapy
15927430|NCT03439358|Drug|Magnesium Sulfate|Bolus infusion: 100mL normal saline with 4g MgSO4 over 30 minutes Maintenance infusion: 25mL normal saline per hour with 1g MgSO4
15927431|NCT03439358|Other|Normal Saline|Bolus infusion: 100mL normal saline over 30 minutes Maintenance infusion: 25mL normal saline per hour
15960806|NCT03182413|Drug|THN102|
15927435|NCT03439319|Other|Conventional Therapy|Conventional training involves repetitive practice of upper extremity movements with manual assistance provided by a therapist as needed.
15927436|NCT03439306|Device|Pulse Oximeter|The Pulse Oximeter are placed on the left and right Index fingers of each subject of the healthy adult volunteer group to evaluate the SpO2 accuracy performance.
15927437|NCT03439293|Drug|Ixazomib|Ixazomib capsule.
15927438|NCT03439293|Drug|Daratumumab|Daratumumab IV infusion.
15927439|NCT03439293|Drug|Dexamethasone|Dexamethasone tablets.
15927440|NCT03439280|Drug|TAK-079|TAK-079 subcutaneously.
15927441|NCT03439280|Drug|Pomalidomide|Pomalidomide orally.
15927442|NCT03439280|Drug|Dexamethasone|Dexamethasone orally.
15927443|NCT03439267|Combination Product|Coronary Artery Calcium Screening and Statin Treatment|Will undergo coronary artery calcium screening and will receive statin treatment based on the cardiovascular risk algorithm.
15927444|NCT03439267|Other|Standard Treatment|Patients will be managed following the AHA/ACC guidelines for statin initiation and follow-up.
15927445|NCT03439254|Drug|Obeticholic acid (10 mg)|Tablets administered orally once daily.
15927446|NCT03439254|Drug|Obeticholic acid (10 mg to 25 mg)|Tablets administered orally once daily.
15927447|NCT03439254|Drug|Placebo|Tablets administered orally once daily.
15927448|NCT03439241|Device|Coloplast ostomy device|the test product is a newly developed Coloplast ostomy device
15927449|NCT03439228|Device|Lumbar brace|3 months of lumbar brace wear
15927450|NCT03439215|Drug|Lorlatinib|Lorlatinib is a novel small-molecule ROS1/ALK inhibitor that was optimized for robust brain penetration.
15927451|NCT03439202|Other|Hypoxia|Subject will conduct low-intensity exercise on a bike in different hypoxic conditions.
15927452|NCT03439189|Combination Product|Methacetin Breath Test|A breath analyzer will be used to measure changes in carbon-12 to carbon-13 ratio as a result of metabolism of the Methacetin substrate before and after treatment.
15927453|NCT03439189|Drug|Emricasan|Investigational drug for NASH treatment in Main Conatus protocol
15927454|NCT03439189|Drug|Placebo oral capsule|Placebo versus emricasan in Conatus NASH treatment trial
15927455|NCT03439176|Other|Standard adhesive 1|This strip contains a standard hydrocolloid adhesive found in ostomy devices
15927456|NCT03439176|Other|Standard adhesive 2|This strip contains a standard hydrocolloid adhesive found in ostomy devices
15927457|NCT03439176|Other|PL4|This strip contains a new adhesive
15927458|NCT03439176|Other|PL16-L|This strip contains a new adhesive
15927459|NCT03439163|Device|MRI scan|All participants underwent the MRI scan
15927460|NCT03439150|Diagnostic Test|Absolute flow and resistance measurement|Absolute flow and resistance measurements immediately after PPCI of the culprit vessel (in a STEMI setting) and repeated absolute flow and resistance measurements after 3-7 days
15927461|NCT03439137|Drug|MT-6548|Oral tablet
15927462|NCT03439137|Drug|Darbepoetin alfa|Intravenous administration
15927463|NCT03439137|Drug|MT-6548-matching placebo|Oral tablet
15927464|NCT03439137|Drug|Darbepoetin alfa-matching placebo|Intravenous administration
15927465|NCT03439124|Drug|ceftobiprole medocaril|"Ceftobiprole medocaril was administered at age-adjusted doses (10, 15 or 20 mg/kg) and infusion durations (2 or 4 hours) every 8 hours. The maximum dose, regardless of body weight, was 500 mg ceftobiprole every 8 hours (maximum total daily dose of 1500 mg ceftobiprole).
~After a minimum of 3 days of IV treatment, patients with sufficient improvement in disease signs and symptoms could be switched to an age-appropriate oral antibiotic to complete a total minimum of 7 days and a total maximum of 14 days' antibiotic treatment."
15927466|NCT03439124|Drug|IV standard-of-care cephalosporin|"Ceftriaxone was administered at 50 to 80 mg/kg IV as a single daily dose, up to a maximum dose of 2 g/day. The actual dose of ceftriaxone within this dose range was determined by the blinded investigator prior to first study drug administration and was not modified during subsequent study days.
~After a minimum of 3 days of IV treatment, patients with sufficient improvement in disease signs and symptoms could be switched to an age-appropriate oral antibiotic to complete a total minimum of 7 days and a total maximum of 14 days' antibiotic treatment.
~At the discretion of the blinded investigator, patients received vancomycin at a dose of 10 to 15 mg/kg IV every 6 hours, up to a maximum dose of 2 g/day, in addition to the IV standard-of-care cephalosporin when MRSA was suspected or confirmed."
15927467|NCT03439111|Dietary Supplement|Standardized Lycium chinense Fruit Extract (LCF) capsules|All dried water extracts and capsules of the Standardized Lycium chinense Fruit Extract (LCF) and Standardized Lycium chinense Fruit Extract (LCF)-matched placebo capsules used in the present study were manufactured and provided by the BIOMIX Company (Ilsan City, Korea).
15927468|NCT03439098|Dietary Supplement|Fermented Codonopsis lanceolata 525mg|Fermented Codonopsis lanceolata 525mg daily for 8 weeks
15927469|NCT03439098|Dietary Supplement|Fermented Codonopsis lanceolata 1050mg|Fermented Codonopsis lanceolata 1050mg daily for 8 weeks
15927470|NCT03439098|Dietary Supplement|Placebo|Placebo daily for 8 weeks
15927471|NCT03439085|Biological|DNA Plasmid-encoding Interleukin-12/HPV DNA Plasmids Therapeutic Vaccine MEDI0457|Given IM and via electroporation
15927472|NCT03439085|Biological|Durvalumab|Given IV
15927473|NCT03439072|Drug|G-Pen|1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector
15927474|NCT03439072|Drug|Lilly Glucagon|1 mg subcutaneous injection of Lilly Glucagon (glucagon injection [RNDA Origin])
15927475|NCT03439059|Behavioral|Reducing Sedentary Behaviour Group|Participants will be prompted to perform 10min of light physical activity (>1.5 METS) 3x/day for 6 weeks
15927476|NCT03439046|Drug|Ribociclib|Ribociclib oral (3weeks on/1week off) in combination with oral once daily letrozole: 600mg tablets ribociclib QD + 2.5 mg tablets letrozole QD
15927477|NCT03439046|Drug|Letrozole|Ribociclib oral (3weeks on/1week off) in combination with oral once daily letrozole: 600mg tablets ribociclib QD + 2.5 mg tablets letrozole QD
15927478|NCT03439046|Drug|Alpelisib|Alpelisib 300 mg oral daily on a continuous dosing schedule in combination with fulvestrant 500 mg intramuscular on Days 1 and 15 of Cycle 1, and on Day 1 of each cycle thereafter in a 28 days cycle
15927479|NCT03439046|Drug|Fulvestrant|Alpelisib 300 mg oral daily on a continuous dosing schedule in combination with fulvestrant 500 mg intramuscular on Days 1 and 15 of Cycle 1, and on Day 1 of each cycle thereafter in a 28 days cycle
15927480|NCT03439033|Drug|PET/MRI with Gallium-68 labeled PSMA-HBED-CC|Subjects have one visit, during which they will undergo one PET/MRI with the study drug, Gallium-68 labeled PSMA-HBED-CC, a radiopharmaceutical
15927481|NCT03439033|Drug|Multiple PET/MRI with Gallium-68 labeled PSMA-HBED-CC|Subjects have two visits (the second visit being optional) within two years. During each visit, they will undergo one PET/MRI with the study drug, Gallium-68 labeled PSMA-HBED-CC, a radiopharmaceutical
15927482|NCT03439033|Drug|PET/CT with Gallium-68 labeled PSMA-HBED-CC|Subjects have one visit, during which they will undergo one PET/CT with the study drug, Gallium-68 labeled PSMA-HBED-CC, a radiopharmaceutical
15927483|NCT03439020|Procedure|Plastic stent anchoring|Insert an additional plastic stent to anchor the fully covered self expandable metal stent.
15927484|NCT03439020|Procedure|FCSEMS|Insert a fully covered self expandable metal stent (FCSEMS) for malignant biliary stricture
15927485|NCT03438994|Diagnostic Test|Play.Care|iPad based game to assess movement as the player interacts with the screen
15927486|NCT03438968|Behavioral|Exercise training|Cardiac Rehabilitation exercise training
15927487|NCT03438955|Drug|Omacor|Omacor soft capsule 4000mg for 16days
15927488|NCT03438955|Drug|Pritor|Pritor tablet 40mg for 7days
15927489|NCT03438955|Drug|Omacor + Pritor|Omacor soft capsule 4000mg + Pritor tablet 40mg for 7days
15927490|NCT03438955|Drug|Pritor + Omacor|Pritor tablet 40mg + Omacor soft capsule 4000mg for 16dyas
15927491|NCT03438942|Dietary Supplement|Folic acid and iron supplementation|Individuals with low level of blood folic acid and iron- will receive folic acid and iron supplementation daily, for 3 months
15927492|NCT03438942|Dietary Supplement|Control group|Individuals with proper level of blood folic acid and iron- will not receive folic acid and iron supplementation daily, for 3 months
15927493|NCT03438929|Device|Diode laser|Diolaze XL blended modes diode laser
15927494|NCT03438903|Device|Repeat exams of OCT device|All 2 consecutive OCT examinations were performed by 1 experienced technician, in the order of SD-OCT and SS-OCT. The interval was 10 minutes between examinations by each OCT devices
15927495|NCT03438890|Device|Warm saline|In subjects allocated to the warm saline group, a thermos flask, which was filled with heated sterile water, was used. A 1000 ml bottle of sterile water was heated to 60 ˚C in a stove for an hour at minimum. Just before introducing into the abdominal cavity, the laparoscope was placed into the thermos flask for 30 seconds at minimum . After each incidence of laparoscopic lens fogging (LLF), the scope was briefly inserted into the thermos flask about 10 seconds, and was then wrapped gauze around the lens before abdominal reinsertion.
15927496|NCT03438890|Device|anti-fog agent|In the anti-fog agent group, Ultra-Stop TM (Sigmaphrarm, Vienna, Austria), which is a commercial anti-fogging solution containing alcohol, surfactant, and water for medical optical devices, was used. Wiping the lens with gauze soaked in Ultra-Stop TM and allowing the surfactant to act for 5 seconds, the laparoscope was introduced into the abdominal cavity. After each laparoscopic lens fogging (LLF), the scope was removed from the abdomen and cleaned using the same corresponding method.
15927497|NCT03438890|Device|chlorhexidine|In the chlorhexidine group, the lens was wiped with gauze soaked in 4% chlorhexidine detergent solution (Firson, Cheonan, Korea) for 5 seconds before introducing into the abdominal cavity, and chlorhexidine was reapplied on the lens at the occurrence of laparoscopic lens fogging (LLF).
15927498|NCT03438877|Procedure|Intensive dosage of PD|Within the first month since PD initiates, PD prescription will be adjusted to achieve the minimum target of 3.5. It's anticipated to prescribe the dosage with automatic PD (APD) or manual PD as 24-36L/day of dialysate, 1.5-2L/exchange, and 16 cycles. Anyway, it depends on the characteristics of the patients, including residual renal function, peritoneal memberane properties. The Kt/V goal will be compromised by clinical assessment for the patient, which means PD will not induce additional treatment, such as fluid infusion.
15927499|NCT03438877|Procedure|Regular dosage of PD|Within the first month since PD initiates, PD prescription will be adjusted to achieve the minimum target of 2.1. It's anticipated to prescribe the dosage with automatic PD (APD) or manual PD as 9-12L/day of dialysate, 1.5-2L/exchange, and 6 cycles. Anyway, it depends on the characteristics of the patients, including residual renal function, peritoneal memberane properties. The Kt/V goal will be compromised by clinical assessment for the patient, which means PD will not induce additional treatment, such as fluid infusion.
15927500|NCT03438864|Device|Electrotherapy, interferential current|Interferential current, entry frequencies and beat frequencies were set differently in 2 groups, amplitude was individualized and increased until patients felt a comfortable tickling sensation.
15927501|NCT03438864|Other|Control|No current except for first 5 seconds, device open but does not appy electrotherapy.
15927502|NCT03438851|Device|NeuroCatch Platform™|NeuroCatch Platform™ consists of software and hardware that captures brain health information. The platform intends to provide a quick, portable and easy to use solution for the acquisition, display, analysis, storage, reporting and management of electroencephalograph (EEG) and event-related potential (ERP) information.
15927503|NCT03438838|Procedure|Laparoscopic Heller's myotomy|"Laparoscopic Heller's myotomy:
~Anterior wall of esophagus is exposed by opening peritoneum and minimal dissection of fat over it. Myotomy is started at 2 cm above the esophago- gastric junction. Initial plane is created using dissector and further muscles are split using pair of dissector or bowel holding forceps for length of 7 to 8 cm with 2 cm over stomach"
15927504|NCT03438838|Procedure|Anterior Fundoplication|The Fundus was sutured with 3 stitches on either side of the esophagus to right and left crus of diaphragm using ethibond(1-0) beside intervening stitch over esophagus. Width of fundoplication is kept approximately at 2cm. The proximal short gastric vessels were divided only if the fundus is insufficiently mobile
15927505|NCT03438825|Procedure|Mitral valve replacement/repair|Mitral valve replacement/repair: standard of care operation of the mitral valve due to severe insufficiency
15927506|NCT03438812|Dietary Supplement|dehydroepiandrosterone (DHEA)|Participants take DHEA 90 mg daily for two months at least before in vitro fertilization cycles.
15927507|NCT03438799|Device|Cordio System|App, cloud and web device
15927532|NCT03438591|Device|Medtronic 4196 lead|Cerclage-CRT pacing with Medtronic 4196 lead (Attain Ability Lead)
15927533|NCT03438578|Device|Efficacy Safety Score monitoring|According to data gathered from ESS and monitoring, the patients will receive needed care.
15927700|NCT03437291|Device|Transvaginal ultrasound|loss of clear zone, Abnormal placental lacunae, Bladder wall interruption, Myometrial thinning, Placental bulge, Focal exophytic mass
15927508|NCT03438786|Procedure|Trans-inguinal Pre-peritoneal Hernioplasty|"patients were catheterised pre-operatively, to prevent any injury to the bladder and aid in preperitoneal dissection. The catheter was removed after 48 hours post-operatively.
~Incision of TIPP is same as that of Lichtenstein technique . After dissection of the sac, the transversalis is fascia is incised to enter the preperitoneal space. The preperitoneal space is developed by dissection with index finger. The space extends from rectus muscle medially, arcuate line cranially, a little beyond the anterior superior iliac spine over the psoas muscle laterally and the lilipubic tract caudally. A 15 cm x 15 cm polypropylene mesh, cut into dimension 15 cm x 12 cm, the inferior medial angle of the mesh is trimmed in a semicircular fashion to prevent trauma to the bladder neck. The mesh is placed in the preperitoneal space and anchored to the Cooper's ligament with a single 2-0 interrupted prolene suture"
15927509|NCT03438786|Procedure|Lichtnestein's hernioplasty|incision 1 cm above and parallel to inguinal ligament,Opening subcutaneous fat ,Opening Scarpa fascia to external oblique aponeurosis ,visualization of external ring and lower border of the inguinal ligament,Opening deep fascia of the thigh,checking for a femoral hernia ,Division of external oblique aponeurosis from external ring laterally for 5 cm, safeguarding ilioinguinal nerve ,Mobilization of superior and inferior flaps of external oblique aponeurosis exposing underlying structures ,Mobilization of spermatic cord along with the cremaster, including (ilioinguinal ,genitofemoral) nerves, and spermatic vessels; all of these structures may be encircled in a tape ,Opening of the coverings of spermatic cord, identification and isolation of the hernia sac ,Inversion, division, resection, or ligation of the sac ,Placement and fixation of mesh to edges of the defect or weakness in the posterior wall of inguinal canal creating artificial internal ring,Closure
15927510|NCT03438773|Drug|Envarsus|Patients randomized into the Envarsus group will be prescribed Envarsus, mycophenolate and prednisone once daily.
15927511|NCT03438773|Drug|Tacrolimus|Patients randomized to the Tacrolimus group will be prescribed Tacrolimus twice-daily with standard of care immunosuppression, anti-proliferative and prednisone once-daily.
15927512|NCT03438760|Behavioral|Science + Phonological Awareness|The goal is to facilitate phonological awareness during science lessons. Because phonological awareness does not relate to science learning, this is a placebo.
15927513|NCT03438760|Behavioral|Science + Grammar Intervention|The goal is to facilitate science learning by providing models, prompts, and experiences with grammatical structures related to science processes.
15927514|NCT03438760|Behavioral|Science + Vocabulary Intervention|The goal is to facilitate science learning by providing models, prompts, and experiences with vocabulary related to science processes.
15927515|NCT03438747|Device|P-15L Bone Graft|The investigational group will be treated with P-15L in an instrumented TLIF
15927516|NCT03438747|Other|Local autologous bone in a TLIF with Instrumentation|The active control group will be treated local autologous bone in an instrumented TLIF
15927517|NCT03438734|Device|Regional cerebral oxygen saturation|Regional cerebral oxygen saturation is a useful clinical research tool for noninvasive and continuous monitoring of hemodynamic and brain oxygenation. Regional cerebral oxygen saturation (Near-infrared spectroscopy system, NIRS, Cerebral Oximeter) monitoring was performed to all patients.
15927518|NCT03438734|Device|Bispectral Index (BIS)|The most effective method for depth of anesthesia and assessment of sedation is bispectral analysis of mean frequency of electroencephalography. The values of BIS decreases with the deepening of anesthesia.
15927519|NCT03438721|Behavioral|Infant obesity prevention|Parents will receive education on infant feeding, sleep, and screen time practices just after well-child visits in the first year of life. The education will be provided by a lay health educator. Parents will also receive text messages to reinforce the intervention content
15927520|NCT03438721|Behavioral|Financial coaching|Parents randomized to the financial coaching arm will receive basic education on financial topics including budgeting, savings, and managing debt as well as coaching on these topics just after well-child visits in the first year of life. Coaching will be provided by lay health educators trained in financial coaching. Parents will also receive text messages reinforcing the information learned.
15927521|NCT03438708|Drug|Axitinib Oral Tablet [Inlyta]|Axitinib 5 milligrams (mg) administered orally (po) twice daily (BID) for 8 weeks (with titration to 7 mg BID as tolerated at 4 weeks)
15927522|NCT03438695|Procedure|Motorized Spiral Enteroscopy|Motorized Spiral endoscope will be inserted and advanced with the assistance of motorized clockwise spiral rotation, After reaching the cecum or if no further advancement of the endoscope can be achieved depth of insertion required for patient treatment or diagnosis, the endoscope will be withdrawn using motorized counter-clockwise spiral rotation, also controlled by the foot pedal. If no total enteroscopy was achieved, a submucosal ink dye injection is performed as an endoscopically visible marker of the maximum insertion depth. A retrograde peranal enteroscopy is then performed on one of the following days.
15927523|NCT03438682|Device|Essure|Essure hysteroscopic sterilization
15927524|NCT03438682|Procedure|Laparoscopic sterilization|Laparoscopic sterilization via electrocautery, ring, or clip.
15927525|NCT03438682|Device|Intrauterine Device (IUD)|Intrauterine Device (IUD)
15927526|NCT03438669|Other|no intervention|no intervention
15927527|NCT03438656|Behavioral|Behavioral Activation|The Adolescent Behavioral Activation Program (ABAP) will be used as the BA protocol. ABAP was developed and validated by McCauley, Dimidjian et al. to adapt BA to adolescents. ABAP is a 12-week protocol that utilizes an idiographic approach to foster rewarding experiences, effective problem solving, and goal attainment, and decrease avoidance, barriers to activation, and depressive rumination that may be contributing to depression severity and maintenance.
15927528|NCT03438643|Diagnostic Test|Blood samples|Blood samples (42mL) will be taken before and during treatment.
15927529|NCT03438643|Diagnostic Test|skin biopsy|skin biopsy will be taken before and during treatment.
15927530|NCT03438617|Behavioral|Peer Support|The intervention involves monthly education/support groups co-led by a CHC doctor / nurse and peer coaches. These meetings will begin with a general discussion about participants' previous month, what they had been doing, any special events etc. Meetings will devote time to identifying goals and specific plans for reaching them, rehearsal and/or discussion of specific behaviors to execute plans and ways in which the group members can be helpful to each other. This will be organized around a Diabetes Action Plan. Peer coaches will also organize activities to promote healthy lifestyles, such as walking groups, to promote informal contacts among peer supporters and participants.
15927531|NCT03438604|Drug|Donepezil TDS|Donepezil Hydrochloride Transdermal Delivery System
15927534|NCT03438565|Device|Asahi Chikai Black 18 neurovascular guidewire|"The Asahi Chikai Black 18 microguidewire employs a reverse tapered shaft with 0.018 tip and 0.014 proximal shaft, which provides additional support and tactile feedback."
15927535|NCT03438552|Radiation|Stereotactic Body Radiotherapy|This radiotherapy may be administered with the CyberKnife® or a linear accelerator allowing stereotactic radiotherapy.
15927536|NCT03438539|Behavioral|Normative Feedback|Subjects assigned to normative feedback will be directed to a statement standardized based on subjects' reported average number of standard drinks per week, age, and gender.
15927537|NCT03438539|Behavioral|Inhibitory Control Training|The inhibitory control training task is a modified version of the Cued Go/No-Go tasks (Weafer and Fillmore, 2012; Miller et al. 1991) and is based on a task currently used in our laboratory targeting cocaine inhibitory control.
15927538|NCT03438539|Behavioral|Working Memory Training|A battery of working memory tasks will be used during the intervention period. These tasks were selected from previous research evaluating working memory training in substance use disorder (Bickel et al., 2011b; Houben et al., 2011b). Tasks will include visuospatial working memory task, digit span task, letter span task, and the n-back task.
15927539|NCT03438526|Drug|Melatonin (Circadin ®)|4 mg of oral melatonin at 8 p.m. for the length of the duration of the hypoactive delirium
15927540|NCT03438526|Drug|Placebo|Lactose monohydrate, cellulose powder, magnesium stearate (Ph. Eur.), mocrocristalline cellulose
15927541|NCT03438513|Behavioral|Occupational Therapy Assessment|The occupational therapy assessment includes a functional evaluation of the disorders impact (activities of daily living)
15927542|NCT03438513|Behavioral|Psychological Assessment|It consists of a detailed history of the patient's experience, an evaluation with the patient (cognitive, emotional, motivational ...), an interview with the caregiver to see the repercussions of the disorders on a daily basis, how they are managed, and how they cope in order to give information and advice.
15927543|NCT03438513|Behavioral|Problem Solving Therapy|Problem-solving learning program for all situations of daily living, done in groups (10 people per group)
15927544|NCT03438513|Behavioral|Speaking group|Intervention, carried out in groups (10 people per group) which will consist of sharing experiences, sufferings, exchange and allow people who attend to share their experiences.
15927545|NCT03438500|Device|Cardiac Extracorporeal Shockwave Therapy (Modulith SLC)|40 - 60 spots per visit (200 shots/spot) at Energy Level 3
15927546|NCT03438487|Biological|Flucelvax Trivalent Influenza Vaccine|"Flucelvax is a cell culture seasonal trivalent influenza vaccine that contains the following influenza hemagglutinin antigens: 1) A/H1N1-like virus, 2) A/(H3N2)-like virus, 3) B/Yamagata lineage or B/Victoria lineage
~Vaccine exposure in routine care (no vaccination per protocol)"
15927547|NCT03438487|Biological|Flucelvax Quadrivalent Influenza Vaccine|"Flucelvax Quadrivalent is a cell culture seasonal quadrivalent influenza vaccine that contains the following influenza hemagglutinin antigens: 1) A/H1N1-like virus, 2) A/(H3N2)-like virus, 3) B/Yamagata lineage, 4) B/Victoria lineage
~Vaccine exposure in routine care (no vaccination per protocol)"
15927548|NCT03438474|Procedure|Standard surgical procedure for endometrial cancer|total hysterectomy, bilateral salpingo-oophorectomy, omentectomy (type 2 cancers)
15927549|NCT03438474|Procedure|systematic lymphadenectomy (LNE)|systematic pelvic and para-aortic lymphadenectomy (LNE) up to the renal vessels
15927550|NCT03438461|Drug|Seltorexant 40 mg|Seltorexant 40 mg as two tablets of 20 mg will be administered as Formulation 1, 2 and 3 orally in Part 1.
15927551|NCT03438461|Drug|Seltorexant 20 mg|Seltorexant as a tablet of 20 mg will be administered as Formulation 1, 2 and 3 orally in Part 2.
15927552|NCT03438448|Other|High sensitive Troponin T monitoring|Three determinations of Roche high-sensitive troponin T (99th percentile (14 ng/L) for each patient: preoperative (during the preoperative visit or just before surgery), 48h, and 72h after surgery. If a rise and/or fall of hs-cTnT with at least one value above the 99th percentile upper reference is detected, a clinical evaluation and a 12-lead ECG will be performed. If no ECG changes, ischemic symptoms, or pulmonary edema to fulfill the diagnostic for PMI the patients will undergo an echocardiographic study.
15927553|NCT03438435|Drug|QRH-882260 Heptapeptide|Imaging agent
15927554|NCT03438422|Dietary Supplement|Pollen extract|1 tablet a day
15927555|NCT03438409|Other|Robotic gait training|Robotic gait training
15927556|NCT03438396|Drug|tisotumab vedotin|All patients will be treated with tisotumab vedotin once every three weeks until progression or toxicity
15927557|NCT03438383|Device|Bi-PAP|The Bi-PAP system combines inspiratory support-IPAP (inspiratory positive airway pressure) with expiratory support-EPAP (expiratory positive airway pressure) and has been used, with good results, in a number of different clinical conditions such as COPD, respiratory failure due to neuromuscular disease, cardiogenic pulmonary edema and immediately post-operatively with pro-phylactic purpose.
15927558|NCT03438383|Device|Sham Bi-PAP|"Sham Bi-PAP was created by introducing a hole at the connection of the mask with the spiral tube of the conventional Bi-PAP system. By doing so, the applied pressure by sham Bi-PAP was constant and equal to 2 cm H2O."
15927559|NCT03438370|Other|Three monthly ART supply at CAGs|Sites where three monthly ART supply will be provided at outreaches
15927560|NCT03438370|Other|Six monthly ART supply at outreaches|Sites where six monthly ART will supply will be provided at outreaches
15927561|NCT03438357|Other|Analysis of cerebral MRI with automatic segmentation software|Pixyl.Neuro software versus manual analysis of lesions
15927562|NCT03438344|Biological|Multi-antigen CMV-Modified Vaccinia Ankara Vaccine|Given IM
15927563|NCT03438344|Other|Laboratory Biomarker Analysis|Correlative studies
15927564|NCT03438344|Other|Placebo|Given IM
15927565|NCT03438331|Behavioral|Cognitive Behavioural Therapy for Insomnia (CBT-I)|The intervention will consist of 8 weekly group sessions (90-min, 5-8 adolescents in each group) of CBT-I delivered within a 10-week window. The treatment components in the CBT-I aim to address the behavioural, cognitive and physiological perpetuating factor of insomnia and include: psycho-education about sleep and sleep hygiene, stimulus control, sleep restriction, relaxation training, structured worry time, cognitive restructuring (targeting sleep-related dysfunctional cognitions), and relapse prevention.
15927677|NCT03437434|Other|Visual Acuity|Ocular Examination
15927701|NCT03437278|Drug|Ligelizumab|Ligelizumab comes in 120 mg per 1 ml liquid vials. Participants received one injection every 4 weeks at a dose of 120 mg or 24 mg, high and low doses respectively.
15927566|NCT03438331|Behavioral|Cognitive Behavioural Therapy for Depression (CBT-D)|The intervention will consist of 8 weekly group sessions (90-min, 5-8 adolescents in each group) of CBT-D delivered within a 10-week window. The main treatment elements of CBT-D include: psycho-education about depression, self-monitoring, behavioural activation, improving social skills, communication skills and problem solving skills, cognitive restructuring (addressing negative and irrational thoughts often associated with depression in adolescents), relaxation techniques, and relapse prevention.
15927567|NCT03438318|Drug|CMP-001|CMP-001 will be administered as per the dose and schedule specified in the respective arms.
15927568|NCT03438318|Drug|Atezolizumab|Atezolizumab will be administered as per the approved label and according to the schedule specified in the respective arms.
15927569|NCT03438318|Radiation|Radiation Therapy|Radiation therapy will be administered using either 3-dimensional (3D) conformal radiotherapy or intensity-modulated radiation therapy (IMRT) to non-target node or metastatic lesion as per the dose and schedule specified in the respective arms.
15927570|NCT03438305|Other|sonar assessment of gastric volume in Diabetic patients|assessment of gastric volume in Diabetic Patients
15927571|NCT03438305|Other|sonar assessment of gastric volume in Non Diabetic patients|assessment of gastric volume in Non- Diabetic Patients
15927572|NCT03438292|Dietary Supplement|Berberine|Two capsules of berberine. Each capsule contains 400 mg berberine. The total amount of berberine throughout is 800 mg.
15927573|NCT03438292|Dietary Supplement|TPGS emulsified berberine|Two capsules of TPGS/Quillaja extract emulsified berberine. Each capsule contains 400 mg berberine. The total amount of berberine throughout is 800 mg.
15927574|NCT03438292|Dietary Supplement|Quillaja extract emulsified berberine|Four capsules of Quillaja extract emulsified berberine. Each capsule contains 200 mg berberine. The total amount of berberine throughout is 800 mg.
15927575|NCT03438279|Other|Non-Interventional|Non-Interventional
15927576|NCT03438266|Device|JUVÉDERM VOLUMA® XC injectable gel with cannula|Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with cannula.
15927577|NCT03438266|Device|JUVÉDERM VOLUMA® XC injectable gel with needle|Participants had 1 cheek treated with JUVÉDERM VOLUMA® XC injectable gel with a needle.
15927578|NCT03438253|Procedure|spinal anaesthesia|
15927579|NCT03438240|Drug|Bupivacaine|patients will receive combined general anesthesia / epidural analgesia with 15 ml bupivacaine 0.20%
15927580|NCT03438240|Drug|Fentanyl|Plus 50 µg fentanyl
15927581|NCT03438240|Drug|Dexmedetomidine|Plus 50 µg dexmedetomidine
15927582|NCT03438227|Drug|Iron dextran|Single intravenous infusion of iron dextran 1000mg.
15927583|NCT03438227|Drug|Ferrous sulfate 325mg|Oral iron supplementation with ferrous sulfate 325mg one to three times daily
15927584|NCT03438214|Drug|Vancomycin Continuous infusion|Will be administered a loading dose of 25mg/kg followed of 2g infused in 24h. Serum levels will be measured after the end of the loading dose (peak) and after 24 hours (steady state). The doses will be adjusted according to serum levels (between 15 and 20 mg / L) and area under curve (AUC) /MIC≥400mg.h/L
15927585|NCT03438214|Drug|Vancomycin Intermittent infusion|Will be administered a loading dose of 25mg/kg followed of 1g every 12h. Serum levels will be measured after the end of the loading dose (peak) and one hour before the next dose (trough). The doses will be adjusted according to serum levels (between 15 and 20 mg / L) and AUC/MIC≥400mg.h/L.
15927586|NCT03438201|Dietary Supplement|Intervention|Enteral feeding that will give the patient the amount of protein between 2.0 - 2.5 Kg/body weight/Day
15927587|NCT03438201|Dietary Supplement|Control|Enteral feeding that will give the patient the amount of protein between 1.0 - 1.2 Kg/body weight/Day
15927588|NCT03438188|Other|Practice Quit Attempt|Smokers will be studied under 2 conditions: smoking as usual and during a 4 day practice quit attempt.
15927589|NCT03438175|Behavioral|Enhanced communication by brochure, website and posters|Several instruments to improve communication toward ICU patients' families were prepared for this study: a brochure of 12 pages, a website with 80 webpages, 8 posters for the waiting room, 1 sign for the ICU door. All these instruments are made to have more correct comprehension and to legitimize emotions of ICU patients' families.
15927590|NCT03438162|Behavioral|Education|Patients randomized in the intervention group received pre-discharge pharmacotherapeutic education. The education was conducted by a qualified physician.
15927591|NCT03438136|Behavioral|Adult Broad Learning Experiment (ABLE)|"This intervention implements six factors from early childhood experiences: individualized scaffolding (having a responsive teacher), forgiving environment (allowing the learner to make and learn from mistakes), growth mindset (believing that abilities can develop with effort), open-minded learning (exploring new experiences), serious commitment to learning (adopting a learning lifestyle), and learning multiple skills simultaneously."
15927592|NCT03438123|Device|CZT SPECT imaging|Acquisition of SPECT (single photon emission computed tomography) imaging utilising a camera system with solid-state cadmium zinc telluride (CZT) detectors to visualise injected, or otherwise introduced, radioactivity in the human body.
15927593|NCT03438084|Dietary Supplement|Interesterified fat|50 g fat provided as commercially available interesterified fat.
15927594|NCT03438084|Dietary Supplement|Non- interesterified fat|50 g fat provided as commercially available non-interesterified fat.
15927595|NCT03438084|Dietary Supplement|Rapeseed oil|50 g fat provided as commercially available rapeseed oil.
15927596|NCT03438084|Dietary Supplement|Butter|50g fat provided as commercially available spreadable butter
15927597|NCT03438071|Other|Videoconferencing|Daily videoconference updates using Skype between parents of preterm infants hospitalized in NICU and the nurse taking care of their child, lasting 5 to 10 minutes, to check with her for the daily news and then see their child through the camera.
15927598|NCT03438058|Other|Graft survival and/or Rejection appearance|
15927599|NCT03438045|Behavioral|Partnered intervention|CHWs will provide dental education and counseling, lead interactive demonstrations of brushing with fluoride toothpaste and flossing, and improve access to dental care through dental coverage enrollment and linkage to local dentists.
15927601|NCT03438019|Device|PrO2|The PrO2 device is linked to a tablet via Bluetooth and provides the user with a graphic representation of their inspiratory effort throughout all of inspiration and real-time biofeedback. This device incorporates a standard 2mm leak to avoid glottal closure during maximal inspiration. The PrO2 provides measures of MIP (cmH2O), SMIP (PTU) and ID (seconds).
15927602|NCT03438019|Device|Threshold Inspiratory Muscle Trainer|The Threshold incorporates a flow-independent one-way valve to ensure consistent resistance and features an adjustable specific pressure setting to be set based on MIP values of each subject.
15927603|NCT03438006|Other|Safety data collection (following routine vaccination)|"This study assessed the safety of GSK Biologicals' Human papillomavirus (HPV) vaccine when administered routinely according to the Prescribing Information in female Chinese subjects aged between 9 and 45 years.
~The intervention consisted in the active surveillance of adverse events following immunization and pregnancy outcomes if the vaccine was administered inadvertently during pregnancy. Information of potential adverse events and pregnancy outcomes were collected at immunisation visits, telephone contacts and through spontaneous reporting by the patient/LAR/physician."
15927604|NCT03437993|Other|Recollect, the game|"Recollect is a working memory training game"
15927605|NCT03437993|Other|Tetris|App-based video game where shapes are rotated and placed to fit a grid
15927606|NCT03437980|Drug|propofol|A bolus of 0.7 mg/kg will be given initially, additional incremental doses of 20 mg propofol will be given if the patient complained of pain or moved arms towards the back. Patients will be sitting on the middle of the operating table facing towards the table's foot. The table's foot will be dropped 45 degrees for a comfortable chair position, Monitoring through pulse oximeter (SaO2), non-invasive blood pressure (NIBP) adjusted every 2 minutes automatic measuring and capnography tube in contact with nostrils.
15927607|NCT03437967|Device|LightForce EXPi|LASER photobiomodulation therapy of 15-25 watts of coherent infrared light to affected area for 10 minutes using wand-type probe.
15927608|NCT03437954|Other|Diet modification|Patients will be randomized to follow the standard post-tonsillectomy diet at our institution, which consists of soft foods for ten days, or will be in the non-restricted diet group following surgery.
15927609|NCT03437941|Drug|CORT125281|CORT125281 is supplied as capsules for oral dosing
15927610|NCT03437941|Drug|Enzalutamide (Xtandi)|Enzalutamide will be taken orally
15927611|NCT03437941|Drug|Placebo|Placebo capsules to match the appearance of the CORT125281
15927612|NCT03437928|Device|Directional Deep Brain Stimulation|Boston Scientific Vercise DBS leads and 16-channel implanted pulse generators (IPGs) will be implanted to control the shape and size of stimulation
15927613|NCT03437915|Radiation|NIBB: accuboost|28.5 Gy delivered in 5 daily fractions
15927614|NCT03437915|Procedure|Partial mastectomy|4-12 weeks post NIBB
15927615|NCT03437902|Dietary Supplement|Rutin in combination with Vitamin C|Rutin and Vitamin C will be supplied as tablets containing 60 mg Rutin and 160 mg Vitamin C. The use of Rutin and Vitamin C will be under the trade name of RUTA C 60 ® manufactured by KAHIRA PHARM.& CHEM. IND. Company
15927616|NCT03437902|Dietary Supplement|Vitamin C|Vitamin C will be supplied as capsules containing500 mg of Vitamin C. The use of Vitamin C will be under the trade name of C-Retard ® manufactured by HIKMA Quality Company.
15927617|NCT03437889|Other|Cold Stimulus (Ice)|The study procedure will be to use a cold stimulus (ice) to assess the subjects for hypesthesia the dermatomes of the lower abdomen between 10 and 30 minutes after the epidural catheter is inserted.
15927618|NCT03437876|Other|intestinal microbiota transplant|All participants take 4 times IMT by gastroduodenoscopy with 2-week intervals
15927619|NCT03437863|Device|Mobile application|Use of a mobile application (on a borrowed device) with following features: 1) strengths reflection and identification, 2) summary of registered strengths, 3) defining goals, and 4) linking strengths to goals.
15927620|NCT03437850|Other|Usual care|Care as usual, in terms of processes and outcomes, will be collected for all participants in both cohorts
15927621|NCT03437824|Drug|Cyanocobalamin|1,000 mg, Once
15927622|NCT03437824|Drug|Placebo|0.9% Sodium Chloride, Once
15927623|NCT03437811|Device|Electro Flo Percussor, Model 5000|FDA 510K K031876 Regulation Number: 21 CFR 868.5665 Regulation Name: Percussor, Powered-Electric Regulation Class: II Product Code: BY1
15927624|NCT03437798|Other|Disease status|Women who reported periodontal disease diagnosis/condition
15927625|NCT03437785|Drug|CKD-495 75mg|CKD-495 75mg Tab.
15927626|NCT03437785|Drug|CKD-495 150mg|CKD-495 150mg Tab.
15927627|NCT03437785|Drug|Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg|Artemisiae argyi folium 95% ethanol ext.(20→1) 60mg Tab.
15927628|NCT03437785|Drug|Rebamipide 100mg|Rebamipide 100mg Tab.
15927629|NCT03437785|Drug|Placebo of the CKD-495 75mg|Placebo of the CKD-495 75mg Tab.
15927630|NCT03437785|Drug|Placebo of the CKD-495 150mg|Placebo of the CKD-495 150mg Tab.
15927631|NCT03437785|Drug|Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg|Placebo of Artemisia Herb 95% Ethanol Soft Ext.(20→1) 60mg Tab.
15927632|NCT03437785|Drug|Placebo of the Rebamipide 100mg|Placebo of the Rebamipide 100mg Tab
15927633|NCT03437772|Behavioral|Mindfulness Cognitive Behavioral Therapy program|16 simultaneous-but-separate therapy sessions for parents and children.
15927634|NCT03437759|Biological|exosomes derived from mesenchymal stem cells (MSC-Exo)|After air-liquid exchange, 50μg or 20μg MSC-Exo in 10μl PBS was dripped into vitreous cavity around MH, leaving 20% SF6 or air as tamponade .
15927635|NCT03437746|Drug|injection of methylprednisolone at anesthetic induction|intravenous administration : 20 mg/kg, over 30 minutes at anesthetic induction
15927636|NCT03437746|Biological|Blood samples|Blood samples (D0, D1, D2, D3, D4)
15927637|NCT03437733|Device|Radiofrequency Ablation|RF ablation using multi-electrode radiofrequency balloon catheter and multi-electrode circular diagnostic catheter
15927638|NCT03437720|Drug|SAR425899|"Pharmaceutical form: Solution for injection
~Route of administration: Subcutaneous injection"
15927639|NCT03437720|Drug|Placebo|"Pharmaceutical form: Solution for injection
~Route of administration: Subcutaneous injection"
15927640|NCT03437707|Drug|Morphine Sulfate|Patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
15927641|NCT03437707|Drug|Intravenous paracetamol|1 g paracetamol will be administered 30 minutes before the end of surgery. All administrations will be applied through IV infusion over 30 minutes. Patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
15927642|NCT03437707|Drug|Intravenous ibuprofen|800 mg ibuprofen (diluted with 250 ml saline) will be administered 30 minutes before the end of surgery. All administrations will be applied through IV infusion over 30 minutes. Patients will be received morphine with intravenous patient controlled analgesia (IV PCA) device during postoperative 24 hours. The PCA solution will be prepared with 100 mg morphine in 200 mL of saline (0.5 mg/ml). The PCA device was adjusted as infusion: 0 ml/h, bolus: 1 ml, lockout period: 7 min.
15927643|NCT03437694|Other|Medication optimization intervention|Pharmacists will engage participants in medication therapy management either with access to the medical records (intervention) or without access (control).
15927644|NCT03437681|Behavioral|Insufficient sleep|Four days of insufficient sleep
15927645|NCT03437668|Drug|WSE|WSE tablets
15927646|NCT03437668|Drug|Placebo Oral Tablet|Placebo tablet
15927647|NCT03437655|Procedure|Carie removal|Carie removal with a low speed handpiece
15927648|NCT03437655|Procedure|Relative isolation|Relative isolation with cotton and gauze.
15927649|NCT03437655|Procedure|Manipulation of the temporary material based on Zinc Oxide and Eugenol|Manipulation of the temporary material based on Zinc Oxide and Eugenol according to the manufacturer's recommendations
15927650|NCT03437655|Procedure|Manipulation of the temporary material based on Mineral trioxide aggregate|Manipulation of the temporary material based on Mineral trioxide aggregate according to the manufacturer's recommendations
15927651|NCT03437655|Procedure|Material insertion on the cavity|Material insertion on the cavity according to the manufacturer's recommendations
15927652|NCT03437655|Procedure|Finishing the temporary direct restoration|Excess cement removal; Occlusal Adjustment; Finishing and polishing.
15927653|NCT03437642|Behavioral|Short Term Psychotherapy|Humanistic-existential psychotherapy derived from ontopsychological method and specifically adapted to public health systems. Individual and group sessions to be tailored to individual needs
15927654|NCT03437629|Procedure|Temporary cement based on Calcium Hydroxide|Confection of a temporary crown with acrylic resin; Finishing and polishing; relative isolation with cotton and gauze; Manipulation of the temporary cement based on Calcium Hydroxide; Cement insertion on the internal surface of the temporary crown; Excess cement removal; Occlusal Adjustment.
15927655|NCT03437629|Procedure|MTA temporary cement|Confection of a temporary crown with acrylic resin; Finishing and polishing; relative isolation with cotton and gauze; Manipulation of the temporary cement based on Mineral trioxide aggregate; Cement insertion on the internal surface of the temporary crown; Excess cement removal; Occlusal Adjustment.
15927656|NCT03437616|Behavioral|Tulppa rehabilitation|The intervention includes health education on e.g. healthy diet, weight management, physical activity and psychosocial coping as well as peer discussions and physical exercises.
15927657|NCT03437603|Drug|Eltrombopag|Starting Eltrombopag daily on empty stomach (2 hour before breakfast) for 8 weeks.
15927658|NCT03437590|Drug|JNJ-55308942|JNJ-55308942 will be administered as oral solution.
15927659|NCT03437590|Drug|[18F]-JNJ-64413739|[18F]-JNJ-64413739 fluid for injection administered intravenously.
15927660|NCT03437577|Drug|immediate-release tacrolimus|Standard of care for transplant patients
15927661|NCT03437577|Drug|extended release tacrolimus|Experimental care
15927662|NCT03437564|Drug|Vortioxetine|Vortioxetine tablet
15927663|NCT03437551|Other|cross-sectional observation|cross-sectional ophthalmic examination
15927664|NCT03437538|Device|MCO-HD|Measurements will be done during a single hemodialysis session with Medium Cut-Off filter
15927665|NCT03437538|Device|High-flux HDF|Measurements will be done during a single hemodiafiltration session with standard high-flux filter
15927666|NCT03437525|Behavioral|Peer Support|The intervention involves monthly education/support groups co-led by a CHC doctor / nurse and peer coaches. These meetings will begin with a general discussion about participants' previous month, what they had been doing, any special events etc. Meetings will devote time to identifying goals and specific plans for reaching them, rehearsal and/or discussion of specific behaviors to execute plans and ways in which the group members can be helpful to each other. This will be organized around a Diabetes Action Plan. Peer coaches will provide education and support for insulin therapy to help reduce barriers around insulin use. Peer coaches will also organize activities to promote healthy lifestyles, such as walking groups, to promote informal contacts among peer supporters and participants.
15927667|NCT03437512|Device|Anodal tDCS|20 minutes of 2mA anodal stimulation.
15927668|NCT03437512|Behavioral|Fluency training|Speaking along with a metronome and/or speaking along with another person (choral speech) for 20 minutes
15927669|NCT03437512|Device|Sham tDCS|For sham stimulation, current is ramped up and back down over 30 seconds.
15927670|NCT03437499|Procedure|Sustained Inflation|Application of positive pressure by face mask with T-piece resuscitator for a prolonged period of 15 seconds at a peak pressure of 25 cmH20 followed by PEEP set at 5 cmH2O
15927671|NCT03437499|Procedure|Positive Pressure Ventilation|Application of positive pressure by face mask with T-piece resuscitator at a peak pressure of 25 cmH20, PEEP set at 5 cmH2, for 40 inflations/minute
15927672|NCT03437473|Device|SetPoint Medical Neurostimulation of the Cholinergic Anti-inflammatory Pathway System|Active Implantable Vagus Nerve Stimulation device.
15927673|NCT03437460|Drug|Ibuprofen 600 mg|The investigators administer one single 600 mg dose of ibuprofen immediately before lunch. Participants are then asked to complete the cold pressor task, flower stringing sessions, and cognitive tasks.
15927674|NCT03437460|Dietary Supplement|Prenatal vitamins|The investigators administer one single prenatal multivitamin immediately before lunch. Participants are then asked to complete the cold pressor task, flower stringing sessions, and cognitive tasks.
15927675|NCT03437447|Drug|Cisticid|Participants received single oral dose of 1200 mg (two 600 mg tablets) Cisticid (Test) on Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2) or Day 15 (Treatment Period 3).
15927676|NCT03437447|Drug|Biltricide|Participants received 600 mg of Biltricide (Reference) tablet at a dose of 1200 mg on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2).
15927678|NCT03437421|Dietary Supplement|Vitamin D3 (cholecalciferol)|"Patients with 29≤ 25-OH-D3 ≥20 ng/mL will receive 200 000 UI orally the first month (100 000 UI at T0 + 100 000 UI at T0+15 days, UVEDOSE™ Laboratoires Crinex, Montrouge, France) followed for the last 2 months by one daily dose (5 drops orally = 1 000 UI/day, DÉDROGYL™ , DB Pharma, La Varenne-Saint-Hilaire, France).
~Patients with : 19≤ 25-OH-D3 ≥10 ng/mL will receive orally 300 000 UI (100 000 UI at T0 + 100 000 UI at T0+23days + 100 000 UI at T0+45days; UVEDOSE™) followed for the last month by one daily dose (5 drops orally =1 000 UI/day, DÉDROGYL™ ).
~Patients with : 25-OH-D3 <10 ng/mL will receive orally 400 000 UI (100 000 UI at T0 + 100 000 UI at T0+15days + 100 000 UI at T0+30 days + 100 000 UI at T0+45days, UVEDOSE™) followed for the last month by one daily dose (5 drops orally =1 000 UI/day, DÉDROGYL™)."
15927679|NCT03437408|Device|Mapping and ablation|High density substrate map. Data collection during ablation
15927680|NCT03437395|Device|Balloon Brachytherapy|The balloon brachytherapy catheter method uses one tube with a small balloon on the end placed where the tumor had been. The balloon is filled with salt water so it fits this space. The end of the tube will extend from the side of the breast and will be connected to a special machine for treatments. The RT dose is delivered by a radioactive seed that travels through the tube into the center of the balloon. The seed will be removed at the end of each treatment. The tube and the balloon filled with salt water will stay in the breast until the 10 RT treatments are done. The radiation oncologist will decide if this type of treatment is most appropriate for the patient. The treatment will be given 2 times a day, about 6 hours apart, on 5 days. Each treatment lasts for 10-15 minutes.
15927681|NCT03437395|Radiation|3D Conformal External Beam Irradiation|3D conformal external beam irradiation uses a beam of radiation to deliver the radiation therapy dose to the place in the breast where the cancer was removed. The Radiation Oncologist will decide which type of treatment is most appropriate for the patient. The treatment will be given 2 times a day, about 6 hours apart, on 5 days. Each treatment lasts for 10 to 15 minutes.
15927682|NCT03437382|Device|Quirem Medical Holmium-166 radioembolization microspheres|radioembolisation as adjuvant treatment to RFA
15927683|NCT03437369|Drug|Ivabradine Oral Tablet|The target dose is 10 to 15 mg / day, administered orally in two doses
15927684|NCT03437369|Other|Standard of Care treatment|The study drug will be compared with the standard of Care treatment
15927685|NCT03437356|Other|Pulmonary vein isolation using CLOSE protocol|'CLOSE' protocol: Ablation index > 400 at the posterior wall (reduce to 300 if esophagus temperature rise), ablation index > 550 at the anterior wall, and inter-lesion distance < 6.0mm
15927686|NCT03437356|Drug|Antiarrhythmic drug therapy (ADT)|"During the first 3 months after PVI, patients continue oral anticoagulants and antiarrhythmic drug therapy (ADT). ADT is a continuation (or restart) of previously ineffective Class IC and III ADT. At the time of discharge, dosage is optimized according to the 2016 ESC guidelines on AF management.
~Preferred dosages:
~Flecainide: Tambocor or Flecainide EG 100mg b.i.d., Apocard R 100 to 200mg overdose (OD) Propafenone: Rytmonorm or Propafenone EG 300 mg b.i.d., except 225 mg b.i.d. if ≥70 years or <70 kg Sotalol: Sotalex or Sotalol EG 80mg b.i.d., Except 80mg t.i.d. if men < 70 years, Cr <1.5mg/dl, >70kg, except 80 mg OD if female >70 years or Cr >1.2mg/dl
~In case of amiodarone intake before PVI, amiodarone is switched to sotalol or class IC ADT."
15927687|NCT03437343|Procedure|Hip arthroplasty|
15927690|NCT03437317|Behavioral|Perceptual Retraining|"Participants viewed faces varying in their expression of anger and were asked to identify if the face was angry or neutral via button press. Participants were provided with feedback if their categorization of the face as neutral or angry was correct. Each participant was assigned 4 levels of angry faces based on their decision point of anger detection in faces. Faces were selected based on the closest existing anger morph to the category boundary; for example, a decision point of 40% anger was closest to the 38% anger face, and so the faces used would have been 17%, 31%, 45%, and 59% anger. For this example, responses of neutral to the 31% angry face would be marked as correct, whereas a similar response to the 45% angry face would be incorrect, as it was above their decision point."
15927691|NCT03437317|Behavioral|Gender Discrimination|Participants viewed faces varying in their expression of anger and were asked to identify if the face was male or female via button press.
15927692|NCT03437304|Biological|Immunose™ FLU 1%|Quadrivalent influenza vaccine with 30 μg HA/strain and 1% Endocine™, dosing volume 200 μl, intranasal administration x 2
15927693|NCT03437304|Biological|Immunose™ FLU 2%, 200 μl|Quadrivalent influenza vaccine with 30 μg HA/strain and 2% Endocine™, dosing volume 200 μl, intranasal administration x 2
15927694|NCT03437304|Biological|Immunose™ FLU 2%, 300 μl|Quadrivalent influenza vaccine with 30 μg HA/strain and 2% Endocine™, dosing volume 300 μl, intranasal administration x 2
15927695|NCT03437304|Biological|Influenza antigen|Quadrivalent influenza vaccine with 30 μg HA/strain, dosing volume 200 μl, intranasal administration x 2
15927696|NCT03437304|Drug|Placebo|NaCl dosing volume 200 μl, intranasal administration x 2
15927697|NCT03437304|Biological|i.m comparator|Quadrivalent influenza vaccine containing 15 μg HA/strain, 500 µl for intramuscular administration x 1
15927698|NCT03437291|Procedure|Cesarean section|Lower segment CS with evaluation of Placental site, spontaneous separation, placental invasion into the bladder and other surrounding organs, Uterotonic administration, Bladder , ureteric or bowel injury, blood loss and blood transfusion
15927699|NCT03437291|Device|Transabdominal ultrasound|loss of clear zone, Abnormal placental lacunae, Bladder wall interruption, Myometrial thinning, Placental bulge, Focal exophytic mass
15927704|NCT03437239|Device|Delfi PTS II Portable Tourniquet System|This is a portable tourniquet system that allows for occlusion of venous outflow without inhibiting arterial blood flow. This portable tourniquet system allows for rapid cuff inflation and deflation with a battery. The Delfi PTS is a purpose-built system that allows for precise control of pressure throughout training, despite the natural changes in muscle shape and length. The device has advanced pressure leak detection that monitors the tourniquet cuff, tubing, and connectors for air leaks and safely alerts staff to hazards or follow-up actions required. The device has visual and audio alarms for over and under pressure and elapsed time as well as a large, easily visible display of tourniquet pressure and elapsed time. The Delfi PTS II calibrates and self-tests on startup. It has a safety interlock that limits the normal maximum pressure and integrated tourniquet cuff testing as recommended in current AORN Standards and Recommended Practices
15927705|NCT03437226|Drug|Levosimendan 2.5 MG/ML|Levosimendan Arm: 1 x 5 ml (1 vial) of levosimendan infusion concentrate is added to one 250 ml infusion bag of 5% glucose or 0.9% NaCl in diabetic patients.
15927706|NCT03437226|Drug|Placebos|Placebo Arm: 1 x 5 ml (1 vial) of placebo levosimendan infusion concentrate is added to one 250 ml infusion bag of 5% glucose or 0.9% NaCl in diabetic patients.
15927707|NCT03437213|Drug|Total intravenous anesthesia group|Induction of general anesthesia with fentanyl, (1mcg / kg), propofol (1-2 mg / kg), atracurium (0.5 mg / kg), intubation. Anesthesia maintained using Propofol (4-6) mg/kg/h, fentanyl (0.5-1) μg/kg/h. to be modified according to analgesic needs and hemodynamics. 10mg atracurium when the 2nd twitch of train of four appears.
15927708|NCT03437213|Drug|Total intravenous plus block group|Ultrasound guidance identifies the paravertebral space using a linear high-frequency (10-12 MHz) probe in the transverse plane in the midline, rotate the probe to the longitudinal plane, and scan in a medial-to-lateral direction. Locate the desired segment shift from the cephalad aspect of the sacrum. The transverse scan will show a hyperechoic outline of the vertebral spinous and transverse processes. Use the loss of resistance technique. Bilaterally inject (5ml) bupivacaine 0.5% for each segment. Induction of anesthesia after 30 minutes with fentanyl, (1mcg / kg), propofol (1-2 mg / kg), atracurium (0.5 mg / kg),then prone position.
15927709|NCT03437200|Drug|Nivolumab|Induction phase: Nivolumab IV 240 mg on days 1, 15 and 29 followed by a maintenance phase (to start on day 43) of Nivolumab IV 240 mg q2 weekly for up to 1 year.
15927710|NCT03437200|Drug|Ipilimumab|Induction phase: Ipilimumab IV 1 mg/kg on day 1 followed by a maintenance phase (to start on day 43) of Ipilimumab IV 1 mg/kg q6 weekly for up to 1 year.
15927711|NCT03437200|Other|Chemoradiation|All patients will receive standard fractionation radiation therapy (RT) scheme: 50Gy in 25 fractions over 5 weeks (i.e. 2Gy per fraction), concurrently with 3 cycles of 2 weeks of FOLFOX (oxaliplatin 85 mg/m2, leucovorin 200 mg/m2, bolus fluorouracil 400 mg/m2, and infusional fluorouracil 1600 mg/m2 over 48 h), followed by 3 cycles of 2 weeks of FOLFOX without RT.
15927712|NCT03437187|Procedure|Cholecystectomy|Laparoscopic technique
15927713|NCT03437161|Radiation|Radiation Therapy (RT)|Undergo RT either in the supine position with DIBH or in the prone position.
15927714|NCT03437148|Device|Innocor®|Inert gas rebreathing device: Innocor® (Innovision, Odense, Denmark)
15927715|NCT03437148|Device|Physioflow®|Bioimpedance cardiograph: Physioflow® (Manatec, France)
15927716|NCT03437135|Diagnostic Test|Glasgow Hearing Status Inventory questionnaire|"This is a questionnaire of the hearing quality presenting eleven questions. This is allows to determine the quality of the hearing status of the patients. It is enough to answer the various questions yes or no."
15927717|NCT03437122|Procedure|Bronchoscopy|Multiple level sampling of the respiratory mucosa (cytology brush and biopsies forceps)
15927718|NCT03437109|Diagnostic Test|Laboratory tests|Testosterone HSBG Hb1Ac LH
15927719|NCT03437096|Other|venipuncture pain|postoperative sleeve gastrectomy patients pain
15927720|NCT03437083|Drug|Eribulin mesylate|intravenous infusion
15927721|NCT03437070|Drug|Trabectedin|Administered intravenously per protocol on Day 1 for 21-day cycles.
15927722|NCT03437070|Drug|Doxorubicin|Administered intravenously per protocol on Day 1 for 21-day cycles.
15927723|NCT03437070|Drug|Olaratumab|Administered intravenously per protocol
15927724|NCT03437057|Other|acetylsalicylic acid (below or equal to) 250 mg|Prospective single-arm study to estimate the risk of renal hematoma when performing a session of lithotripsy for renal lithiasis, on a 15-day scanner, in patients treated with acetylsalicylic acid not suspended.
15927725|NCT03437044|Drug|Ticagrelor|After providing written informed consent and following diagnostic angiography, patients meeting study entry criteria undergoing PCI will be randomly assigned in a 1:1 ratio to treatment with either ticagrelor or clopidogrel. Randomized treatment will be maintained for 30±3 days.
15927726|NCT03437044|Drug|Clopidogrel|After providing written informed consent and following diagnostic angiography, patients meeting study entry criteria undergoing PCI will be randomly assigned in a 1:1 ratio to treatment with either ticagrelor or clopidogrel. Randomized treatment will be maintained for 30±3 days.
15927727|NCT03437031|Device|Virtual Reality device|For those patients randomized to VR, the study staff member will explain the use of the Samsung VR goggle set, and thereafter will allow the patient to use the device freely for up to 30 minutes. Intervals of 2-5 minutes is suggested for first-time use, and patients will be to allowed to discontinue it at any time as long as they are not experiencing any discomfort or side effects (dizziness, motion sickness, etc.). The study staff member will be present at all times, and will work with hospital staff as necessary to ensure the patient is receiving appropriate clinical care throughout the duration of the intervention.
15927728|NCT03437018|Other|moderate diabetic retinopathy follow-up by tele-expertise|"Consultation by an orthoptist to measure visual acuity, eye tone by pulsed air tonometer, and retinography images after pupillary dilatation (9 photographs: one of the posterior pole and 8 of the peripheral retina) and optical coherence tomography (OCT).
~The results are immediately evaluated on site by an ophthalmologist. The results are sent through a secure online medical application to a diabetic retinopathy specialist ophthalmologist for evaluation."
15927729|NCT03437005|Drug|Desonide 0.05%|Desonide 0.05% ointment topically twice daily for two weeks
15927730|NCT03437005|Drug|Ketoconazole 2%|Ketoconazole 2% cream topically twice daily for two weeks
15927731|NCT03436992|Dietary Supplement|Antioxidant Cocktail|Vitamin C, Vitamin E, alpha lipoic acid
15927732|NCT03436992|Dietary Supplement|Resveratrol|1500 mg trans-resveratrol
15927733|NCT03436992|Other|Placebo|placebo
15927734|NCT03436979|Device|NeuGuide™ System|The NeuGuide™ device is indicated for anchoring sutures to ligaments of the pelvic floor.
15927735|NCT03436966|Device|MULTI SLICE CT|Positive enteric contrast, can, however, obscure IV contrast enhancement of the bowel wall. In addition, positive oral contrast agents opacify but do not always well distend the bowel. IV contrast is administered and images are acquired in the portal venous phase, which is optimized for visceral organ evaluation.
15927736|NCT03436953|Drug|CX-8998|T-type calcium channel blocker
15927737|NCT03436953|Drug|Placebo|Placebo comparator
15927738|NCT03436940|Other|On Demand Discharge Planning (DDP)|Patients with an intermediate score, according to the simplified Blaylock Risk Assessment Screening Score, are addressed to the NOCC team (hospital Continuity of care team) only in case of a specific request by the unit of hospitalization.
15927739|NCT03436940|Other|Routine Discharge Planning (RDP)|All patients with an intermediate threshold value of the simplified Blaylock Risk Assessment Screening Score are submitted to discharge planning by the NOCC team (Hospital Unit of Continuity of Care)
15927740|NCT03436927|Other|Nintendo Wii Fit Balance exercises|Nintendo Wii Fit' training protocol consisted of 'Penguin Slide', 'Table Tilt', 'Ski Slalom', 'Heading' and 'Balance Bubble' games that selected from the Wii Fit Plus balance games section
15927741|NCT03436927|Other|Balance Trainer Balance Exercises|Balance Trainer' training protocol consisted of 'Collect Apples', 'Outline', 'Paddle War' and 'Evaluation of Movement' games which were included in the device software and allowed the patients to done balance exercises in different directions.
15927742|NCT03436914|Drug|PPI|After the diagnosis of NERD through patient's symptom and endoscopy, PPI (esomezol) will be given for 8 weeks. The effect of PPI for NERD patients will be analyzed.
15927743|NCT03436901|Diagnostic Test|MRI with DWI vs CT|MRI with diffusion weighted imaging of thorax, abdomen, and pelvis without contrast agent vs. CT of thorax, abdomen, and pelvis with contrast agent
15927744|NCT03436875|Diagnostic Test|Mixed meal challenge|"We will conduct a traditional oral glucose tolerance test (OGTT), and compare microvascular and metabolic responses with mixed meal challenge (MMC). The procedures between the two are identical except for what is being consumed. In brief, the OGTT will be 75 g of glucose, and the MMC will be a protein shake consisting of 30g of protein, 5 g of fat, and 35g of carbohydrate.
~A fasting sample of blood will be collected, and the test drink (either OGTT or MMC) will be given. We will collect blood to measure glucose at: 15, 30, 60, 90, and 120 min post-drink consumption. We hypothesize that, like in Caucasians (under review), healthy Hispanics will have greater microvascular blood flow in skeletal muscle with the MMC than with OGTT, and this increased blood flow will result in greater substrate oxidation switching (metabolic flexibility)."
15927746|NCT03436849|Drug|ESN364|ESN364 will be administered orally.
15927747|NCT03436849|Drug|Placebo|Placebo will be administered orally.
15927748|NCT03436836|Drug|Nalbuphine|"Both groups received 8 ml solution for the peribulbar block, Patients of group N was received a mixture of 3 ml of 2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75IU)(16) and 4mg of nalbuphine in 1 ml normal saline. Patients of group C was received a mixture of 3 ml of 2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75 IU) and 1 ml normal saline. Nalbuphine (20mg amp.) was prepared in 0.9% sodium chloride in 5mL syringe.
~If the block was inadequate after 10 minutes, a 2-4 ml supplementation of local anesthetics was given by the same technique and the patient was excluded from the study.
~After adequate analgesia (loss of sensation to touch by a small cotton wool) and akinesia, the surgeon was allowed to start the surgery"
15927749|NCT03436836|Drug|lidocaine, bupivacaine, hyaluronidase , saline|lidocaine, 0.5% bupivacaine, 1 ml hyaluronidase (75 IU) and 1 ml saline (total 8 ml).
15927750|NCT03436836|Drug|lidocaine, bupivacaine , hyaluronidase|2% lidocaine, 4 ml of 0.5% bupivacaine with hyaluronidase (75IU)
15927751|NCT03436823|Other|nurse semi-structured interview|The first session of rTMS is D1. From the first meeting to D14 semi -structured interviews are set up
15927752|NCT03436823|Other|Music & Relaxation with eyes closed|The first session of rTMS is D1. From the first meeting to D14 music & relaxation with eyes closed sessions are set up
15927753|NCT03436810|Procedure|Motor imagery|Motor imagery (MI) will be trained for the individuals by imagination of the movement. Program of MI includes 1) body relaxation and awareness 2) visual imagery 3) kinesthetic imagery and 4) refocusing of body and environment.
15927754|NCT03436810|Procedure|Health education|Topic of Health education (HE) consists of 1) Changes caused by stroke 2) Complications after stroke 3) Emotional changes after stroke 4) Living at home after stroke 5) High blood pressure and stroke and 6) Preventing recurrent stroke.
15927755|NCT03436810|Procedure|Task-Oriented Circuit Class Training|Program of Task-Oriented Circuit Class Training (TOCCT) consists of warm up and perform tasks 1) Stepping forward-backward onto block 2) Stepping sideway onto block 3) Heel lifts in standing to strengthen affected planter-flexor muscles 4) Standing with a decreased base and reach for object 5) Standing up from chair, walking a short distance, and returning to chair 6) Symmetrical walking and 7) Walking at fast speed.
15927756|NCT03436797|Drug|AK002|AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8, a member of the CD33-related family of sialic acid-binding, immunoglobulin-like lectins (Siglecs).
15927757|NCT03436784|Behavioral|Indiana SNAP-Ed|First four Indiana SNAP-Ed nutrition education lessons served as the intervention
15927758|NCT03436771|Genetic|JCAR017|No drug is administered in this study. Patients who received JCAR017 in a previous trial will be evaluated in this trial for long-term safety and survival.
15927759|NCT03436771|Genetic|JCARH125|No drug is administered in this study. Patients who received JCARH125 in a previous trial will be evaluated in this trial for long-term safety and survival.
15927763|NCT03436719|Drug|Oral antibiotic|Metronidazole - 500 mg and Erythromycin - 500 mg per os *3 times at 5 p.m.; 8 p.m., 11 p.m. in a day before surgery
15927764|NCT03436719|Drug|Intravenous antibiotic|Cefoperazone - 1000 mg intravenously for 30-90 minutes before surgery
15927765|NCT03436719|Drug|Mechanical Bowel Preparation|Beginning of MBP at 4 p.m. in a day before surgery
15927766|NCT03436706|Other|exposure|exposure to chronic stress
15927767|NCT03436693|Drug|Canagliflozin|Canagliflozin 100mg orally once daily
15927768|NCT03436693|Drug|Placebo|Placebo orally once daily
15927769|NCT03436680|Other|Best Practice|Receive standard of care
15927770|NCT03436680|Behavioral|Neurofeedback|Complete neurofeedback training sessions
15927771|NCT03436680|Other|Quality-of-Life Assessment|Ancillary studies
15927772|NCT03436680|Other|Questionnaire Administration|Ancillary studies
15927773|NCT03436667|Diagnostic Test|Spirometry|Lung volumes will be measured using spirometry.
15927774|NCT03436667|Diagnostic Test|Reaction Time|PVT-192 Psychomotor Vigilance Task Monitor is a hand-held, self-contained system used for repetitive reaction time measurement.
15927775|NCT03436654|Drug|Apalutamide|240mg daily orally
15927776|NCT03436654|Drug|Abiraterone Acetate|1000mg daily orally
15927777|NCT03436654|Drug|Prednisone|5mg BID orally
15927778|NCT03436654|Procedure|Radical Prostatectomy|A laparoscopic, robotic-assisted, or open approach to RP is permitted at the discretion of the operating surgeon.
15927779|NCT03436654|Procedure|Extended Pelvic lymphadenectomy|To be performed concurrently with prostatectomy. Bilateral pelvic lymphadenectomy should include complete removal of all pelvic lymph nodes within the broad template described and includes the external iliac, hypogastric, obturator, and pre-sacral lymph nodes
15927780|NCT03436654|Drug|GnRH agonist/antagonist|Physician's choice, for a total duration not to extend beyond the treatment phase of the protocol or 10 months from the start of investigational agent(s)
15927781|NCT03436641|Other|No intervention|No intervention
15927782|NCT03436628|Device|MyT1DHero|A mobile phone application
15927783|NCT03436615|Drug|SB206 4%|Twice daily
15927784|NCT03436615|Drug|SB206 8%|Twice daily
15927785|NCT03436615|Drug|SB206 12%|Once or twice daily
15927786|NCT03436615|Drug|Placebo|Once or twice daily
15927787|NCT03436589|Behavioral|Indiana SNAP-Ed|First four Indiana SNAP-Ed nutrition education lessons served as the intervention
15927788|NCT03436576|Drug|Autologous Serum 20%|Instillation of 1 drop of Autologous Serum 20% four times a day
15927789|NCT03436576|Drug|Autologous Serum 50%|Instillation of 1 drop of Autologous Serum 50% four times a day
15927790|NCT03436563|Biological|Anti-PD-L1/TGFbetaRII Fusion Protein M7824|Given IV
15927791|NCT03436550|Procedure|mpMRI|Multiparametric MRI
15927792|NCT03436550|Procedure|ARFI US|Acoustic radiation force impulse is a type of ultrasound elastography
15927793|NCT03436537|Other|Periodontal Aesthetic Perception Scale|Patients answered the self-reported 7-item questionnaire for Periodontal aesthetic perception scale
15927794|NCT03436498|Drug|Insulin aspart SAR341402|"Pharmaceutical form: Solution
~Route of administration: Subcutaneous"
15927795|NCT03436498|Drug|Insulin aspart|"Pharmaceutical form: Solution
~Route of administration: Subcutaneous"
15927797|NCT03436472|Drug|dexmedetomidine|low-dose dexmedetomidine infusion
15927798|NCT03436472|Drug|placebo|normal saline infusion
15927799|NCT03436459|Device|Extracorporeal Shock Wave Therapy|shock wave therapy once a week for three weeks, total of 1000 shock waves for each treatment at the frequency of 10Hz, with 2 Bar pressure and energy flux density (EFD) of 0.25 mJ/mm2 per minute using a BTL-6000 SWT Topline Power® device
15927800|NCT03436459|Device|Low Level Laser Therapy|LLLT once a day for three weeks (altogether 15 working days) using a PR999 4W scanning laser device; around trigger points with 3 J/cm2, power 800 mW, frequency 2000Hz, on trigger points with 9 J/cm², power 2000mW, frequency 5000Hz for total of 2 minutes on each spot
15927801|NCT03436446|Other|Interview|Interviews will be conducted with orthopedic patients to review the construction and phrasing of various social incentives aimed at promoting patient reported outcome collection amongst post-operative patients.
15927802|NCT03436433|Drug|Lacosamide|LCM 100mg twice a day.
15927803|NCT03436433|Drug|Levetiracetam|LEV 1000mg twice a day.
15927804|NCT03436420|Drug|Gemcabene|Participants will take 300 milligrams (mg) of gemcabene, once per day for 12 weeks.
15927805|NCT03436394|Drug|Evobrutinib|Subjects will be administered a single oral dose of evobrutinib under fasting conditions.
15927806|NCT03436381|Other|Questionaire|We will provide two sleep apnea screening questionnaire, Stop-bang questionnaire and Epworth sleepiness scale
15927807|NCT03436368|Procedure|Continuous spinal anesthesia|Continuous spinal anesthesia will be performed for patients of the CSA group at the L3-L4 intervertebral space using Spinocath (B. Braun, Melsungen, Germany). After the cerebrospinal fluid is aspirated, 7.5 mg hyperbaric Bupivacaine 0.5% (1.5 ml) together with 25 micrograms Fentanyl (0.5 ml) will be injected intra-thecally. Supplemental injections will be given in aliquots of 5 mg hyperbaric Bupivacaine 0.5% (1 ml) if the sensory block is lower or reseeds, during surgery, below T6 dermatome.
15927808|NCT03436368|Procedure|General anesthesia|Anesthesia will be induced with intra-venous administration of Fentanyl (2 micrograms/kg), Ptopofol (1-2 mg/kg) and Atracurium (0.5 mg/kg). Maintenance will be achieved with 0.8-1.5% Isoflurane in an O2 / air mixture, an Atracurium infusion at 0.5 mg/kg/hr and a Fentanyl infusion at 1 micrograms/kg/hr.
15927809|NCT03436355|Behavioral|Physical activity|"The Active school study was a 10-month randomized controlled trial.The weekly interventions were 2×45 minutes physically active academic lessons, 5×10 minutes physically active breaks, and 5×10 minutes physically active homework."
15927810|NCT03436342|Drug|68Ga-Pentixafor|Intravenous injection of one dosage of 74-148 MBq (2-4 mCi) 68Ga-Pentixafor. Tracer doses of 68Ga-Pentixafor will be used to image lesions of MM and lymphoma by PET/CT.
15927811|NCT03436329|Procedure|Vein ligation first|During this procedure, patients undergo lobectomy with the pulmonary vein ligated first.
15927812|NCT03436329|Procedure|Artery ligation first|During this procedure, patients undergo lobectomy with the pulmonary artery ligated first.
15927813|NCT03436316|Drug|AZD8154|SAD Part 1; 6 cohorts which receive single dosing. One cohort is invited back for large particle administration. Part 2; 1 cohort which receives IV dose and then inhaled administration of AZD8154. MAD Part 3; 3 cohorts will receive inhaled multiple dosing. Additional doses are provisional and could be adjusted based on the emerging data from the previous dose by the safety review committee (SRC).
15927814|NCT03436303|Drug|CEE 0.625 mg/MP 100mg|CEE 0.625 mg daily/MP 100mg daily for the last 12 days of every 28 days for two years
15927815|NCT03436303|Drug|CEE 0.3 mg/MP 100mg|CEE 0.3 mg daily/MP 100mg daily for the last 12 days of every 28 days for two years
15927816|NCT03436303|Drug|CEE 0.625mg/dydrogesterone|CEE 0.3 mg/dydrogesterone 10mg daily for the last 12 days of every 28 days for two years
15927817|NCT03436290|Behavioral|Palliative Care Intervention|These patients will receive the palliative care intervention.
15927818|NCT03436277|Drug|L-Carnitine|L-Carnitine oral solution 1.5 g diluted in 250 ml of water, before crossfit training, 5 times a week for 8 weeks
15927819|NCT03436277|Dietary Supplement|Sucralose|Sucralose 1.5 g diluted in 250 ml of water, before crossfit training, 5 times a week for 8 weeks
15927820|NCT03436264|Other|MRI|fMRI
15927821|NCT03436251|Device|Local Hyperthermia at 37℃|As a control, for patients with HPV+/CIN-1 or HPV+ with normal cytology, hyperthermia at 37℃ is applied
15927822|NCT03436251|Device|LEEP or cold knife|For patients with HPV+ / CIN-2
15927823|NCT03436251|Device|Local Hyperthermia at 44℃|As an experimental arm, for patients with HPV+/CIN-1/CIN2 or HPV+ with normal cytology
15927824|NCT03436225|Drug|Dexamethasone orally.|Administered orally (0.15mg /kg / dose) twice daily for 3 to 5 days.
15927825|NCT03436225|Drug|Dexamethasone parenteral.|Administered parenteral (0.15mg /kg / dose) twice daily for 3 to 5 days.
15927826|NCT03436225|Drug|Inhaled nebulized Budesonide.|Administered for inhalation (1 mg/ 2ml) twice daily for 3 to 5 days.
15927827|NCT03436225|Drug|Inhaled nebulized salbutamol.|Administered for inhalation (0.15mg /kg / dose) daily every 6-8hrs
15927828|NCT03436212|Device|Continuous Glucose Monitoring (CGM)|DEXCOMG4 device
15927829|NCT03436199|Drug|ADS-5102, 137 mg|Oral capsules to be administered once daily at bedtime
15927830|NCT03436199|Drug|ADS-5102, 274 mg|Oral capsules to be administered once daily at bedtime
15927831|NCT03436199|Other|Placebo|Oral capsules to be administered once daily at bedtime
15927832|NCT03436173|Drug|Fluoxetine|Fluoxetine 10 mg/2.5 ml mixed with water
15927833|NCT03436173|Other|Peppermint syrup|Liquid peppermint syrup measured to the equivalent volume and mixed with water
15927834|NCT03436160|Drug|WR826647|100 mcg Carbon-14 radio labeled WR826647 at an exposure no greater than 250 nCi per dose, administered both IV (bolus) and PO with a six half-life wash-out period between IV and PO administration. Interim analyses will be done at Day 14 following the IV dosing groups in order to assess half-lives of the three compounds to ensure the wash-out period between IV and PO dosing is at least six half-lives long.
15927835|NCT03436160|Drug|WR909388|100 mcg Carbon-14 radio labeled WR909388 at an exposure no greater than 250 nCi per dose, administered both IV (bolus) and PO with a six half-life wash-out period between IV and PO administration. Interim analyses will be done at Day 14 following the IV dosing groups in order to assess half-lives of the three compounds to ensure the wash-out period between IV and PO dosing is at least six half-lives long.
15927836|NCT03436160|Drug|WR909390|100 mcg Carbon-14 radio labeled WR909309 at an exposure no greater than 250 nCi per dose, administered both IV (bolus) and PO with a six half-life wash-out period between IV and PO administration. Interim analyses will be done at Day 14 following the IV dosing groups in order to assess half-lives of the three compounds to ensure the wash-out period between IV and PO dosing is at least six half-lives long.
15927837|NCT03436147|Other|POP-Q|Pelvic Organ Prolapse Quantification
15927838|NCT03436134|Other|Sessions of conventional apheresis|"Patient receiving sessions of Plasma exchange as treatment of chronic antibody mediated rejection.
~The plasma exchange uses a single filter to remove whole plasma and the volume is replaced with a matched volume of blood products +/- saline.) 8 sessions plasma exchange.Patients will have one session per day, 4 consecutive days and then three days without, then one session per day for 4 consecutive days. That's 11 days of treatment at all. The fourth and eighth sessions will be followed by an infusion of Rituximab 375 mg / m2.
~At the beginning and at the end of each session, the patients will have a blood test to measure the parameters of the routine care and the analyzes, collection of biological samples planned for the study."
15927839|NCT03436134|Other|Sessions of news apheresis with double filtration|"Patient receiving DFPP as treatment of chronic antibody mediated rejection. 8 sessions
~A Double filtration plasmapheresis (DFPP) is a variation of plasma exchange. The circuit contains two plasma filters : the first is a standard plasma filter and the second is a high molecular weight filter that primarily removes immunoglobulins. The depleted plasma is returned to the blood circuit and then to the patient."
15927840|NCT03436121|Drug|Ketamine|"Ketamine is a medication approved by the US Food and Drug Administration (FDA) for anesthesia, sedation, and post-surgical pain treatment. It is not approved for emergency patients complaining of pain but is often used off-label. Ketamine may be useful for acute pain management and in treatment of depressed mood. The purpose of this study is to determine whether a single low dose of ketamine can relieve pain and reduce negative mood for 2 weeks after emergency department (ED) treatment."
15927841|NCT03436121|Drug|Midazolam|In this study, all patients will also receive midazolam. Midazolam is a sedative that typically makes people feel relaxed and is intended to increase comfort with ketamine and reduce anxiety.
15927842|NCT03436121|Drug|Placebo|In this study, patients in the active comparator group will receive midazolam first, then placebo. A placebo is an inactive solution that looks like the study drug, but contains no active ingredients.
15927843|NCT03436108|Diagnostic Test|Measurement of Bisphenol in blood|to see level of this material in blood of women
15927844|NCT03436095|Other|bundle measures|Implementation of bundle measures to improve the successful rate of weaning ventilator
15927845|NCT03436082|Device|A mobile health platform|Patients pilot testing the smartphone based, mobile health platform called HUGO. Patients will also be given syncable devices to use that will provide additional insights into their health and health outcomes.Patients will be queried about specific symptoms related to their procedure at enrollment, one week post-procedure, at 4 weeks and again at 8 weeks.
15927846|NCT03436069|Other|Conventional treatment protocols of breast cancer|
15927847|NCT03436056|Radiation|Stereotactic Body Radiotherapy (SBRT) 30 Gy 3 fractions (#)|Stereotactic Body Radiotherapy (SBRT) dosed at 30 Gy in 3 fractions (#) in week 3
15927848|NCT03436056|Radiation|Stereotactic Body Radiotherapy (SBRT) 54 Gy 3 fractions (#)|Stereotactic Body Radiotherapy (SBRT) dosed at 54 Gy in 3 fractions (#) in week 3
15927849|NCT03436056|Radiation|Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose|Stereotactic Body Radiotherapy (SBRT) dosed at the maximum tolerated dose (MTD) determined in Part A in week 3
15927850|NCT03436056|Drug|Pembrolizumab|Pembrolizumab in week 1 dosed at 200 mg (prior to SBRT) and then treatment with pembrolizumab will be continued dosed at 200 mg given every 3 weeks.
15927851|NCT03436043|Device|Transmural Plastic stenting|After metal stent removal in patients of disconnected pancreatic duct syndrome, transmural plastic- double pig tail stent will be placed into the residual necrotic cavity with the standard duodenoscope.
15927852|NCT03436030|Other|Simple breathing manuevers during brief echocardiographic imaging|Valsalva, Muller, light mask CPAP, leg raising, hand grip.
15927853|NCT03436017|Other|Metabolomic approach|Biological samples (blood and urine) for a multimodal metabolomic approach
15927854|NCT03436004|Device|Colonoscopy|Patients undergoing screening colonoscopy
15927855|NCT03436004|Device|Colonoscopy with specific device (Endocuff Vision)|Patients undergoing screening colonoscopy using the Endocuff Vision device
15927856|NCT03435991|Other|Validation Experience Sampling Method 'Uromate'|In a period of 7 days, participants will fill out an electronic ESM assessment at 10 random moments during the day. Moreover, they will fill out a sensation-related bladder diary (SR-BD) during the last three consecutive days of filling out the ESM and several symptom questionnaires at the end of the study period.
15927857|NCT03435978|Behavioral|MetS+|
15927858|NCT03435978|Other|MetS-|Data processing from Patient Medical Files
15927859|NCT03435965|Diagnostic Test|AmnioQuickDuo+|AmnioQuickDuo+ kit for detection of PROM
15927860|NCT03435952|Drug|Pembrolizumab|200 mg by intravenous infusion starting on Day 0, and continuing every 3 weeks for up to 12 months.
15927861|NCT03435952|Biological|Clostridium Novyi-NT|"Participants given a single dose of Clostridium Novyi-NT by intratumoral injection on Day 8.
~Clostridium Novyi-NT administered starting with Cohort 1 at a dose of 3 x 10^4 spores followed by dose escalation."
15927862|NCT03435952|Drug|Doxycycline|Starting on Day 15, participant takes Doxycycline by mouth 2 times a day for the rest of participant's life to lower the risk of further growth of Clostridium novyi-NT
15927863|NCT03435939|Drug|Losartan|50 mg/day for 7 days followed by 100 mg/day for 12 weeks
15927864|NCT03435913|Other|Standard PEEP ventilation|During mechanical ventilation a fixed PEEP (5 mcH2O) is set at all IAP levels during pneumoperitoneum insufflation
15927865|NCT03435913|Other|Matched PEEP ventilation|During mechanical ventilation PEEP is matched to IAP level
15927866|NCT03435900|Drug|Combination of fosfomycin, metronidazole and rhGM-CSF (administered together intraperitoneally) and three days of antibiotics p.o.|All drugs will be administered together intraperitoneally at the end of the surgery after the appendix has been removed. Hereafter, the intervention group will receive three days of orally administered antibiotics: 500 mg amoxicillin combined with 125 mg clavulanic acid and 500 mg metronidazole. These doses will be administered three times daily.
15927867|NCT03435900|Drug|Standard antibiotics intravenously|4 g piperacillin/500 mg tazobactam and 1 g metronidazole administered intravenously during surgery followed by 4 g piperacillin/500 mg tazobactam and 500 mg metronidazole administered intravenously three times daily for three days.
15927868|NCT03435887|Behavioral|Alere q HIV-1/2 Detect for point of care infant testing|The investigators will pilot the Alere q HIV-1/2 Detect mobile system for point of care (POC) infant testing at two of the study hospitals. A blood sample will be collected from each HIV-exposed infants at birth (before discharge from Maternity or at first follow-up MCH visit within 14 days postnatal) and at 6-week EID visit (4-8 weeks postnatal) for analysis with Alere q HIV-1/2 Detect, with results available within 1-2 hours to enable mother notification at the same clinic visit.
15927869|NCT03435887|Behavioral|GeneXpert HIV-1 Qual for point of care infant testing|The investigators will pilot the GeneXpert HIV-1 Qual mobile system for point of care (POC) infant testing at two of the study hospitals. A blood sample will be collected from each HIV-exposed infants at birth (before discharge from Maternity or at first follow-up MCH visit within 14 days postnatal) and at 6-week EID visit (4 to <24 weeks postnatal) for analysis with GeneXpert HIV-1 Qual, with results available within 1-2 hours to enable mother notification at the same clinic visit.
15927870|NCT03435887|Behavioral|HIV DNA PCR testing (Standard of Care)|This is the standard of care for infant HIV testing. A dried blood spot sample will be collected from the infant and shipped to a central laboratory for HIV DNA PCR testing. Results will then be returned to the hospital.
15927871|NCT03435874|Biological|ChAd63 RH5|Vaccine
15927872|NCT03435874|Biological|MVA RH5|Vaccine
15927873|NCT03435874|Biological|Rabies Vaccine|Vaccine
15927874|NCT03435861|Drug|VX-745|active drug capsules
15927875|NCT03435861|Drug|placebo|placebo capsules
15927876|NCT03435848|Drug|BST-236|1 to 4 courses
15927877|NCT03435835|Device|Control/Sham Treatment|Thermoneutral water (33ºC) will be circulated through water-circulating trousers to maintain skin temperature at baseline levels.
15927878|NCT03435835|Device|Heat Therapy (HT)|Water at 42-43ºC will be circulated through the water-circulating trousers.
15927879|NCT03435822|Other|asthma action plan management group|Patients will follow the directions in asthma action plan when their asthma get worse.
15927880|NCT03435822|Other|conventional management group|Patients will follow the directions in conventional strategy when their asthma get worse.
15927881|NCT03435809|Procedure|Intrauterine insemination|Obligatory use of a Pozzi forceps tenaculum during intrauterine insemination
15927882|NCT03435796|Genetic|Gene-modified (GM) T cell therapy|Gene-modified (GM) T cell therapy
15927883|NCT03435783|Behavioral|Brief Electronic Intervention|The brief electronic intervention will allow users to receive normative feedback based on their alcohol use and sexual activity. Users who show interest in changing their behavior will also be asked to create a plan to do so.
15927884|NCT03435783|Behavioral|Attention-Matched Control|Participants will view a video clip on general health promotion that is a similar length as the intervention arm.
15928248|NCT03433079|Diagnostic Test|Interleukin-6 (IL-6)|The level of interleukin-6 was assessed in all patients.
15927885|NCT03435770|Device|EUSRA RFA needle|A 19-gauge RFA electrode and a RF generator with a electrode that is needle-shaped and echogenic that allows EUS guided puncture of the target lesion. The active electrode tip is 1 cm in length. During ablation, the RF electrode is cooled and perfused internally with circulating chilled saline solution (0°C) delivered via a pump to maintain a constant temperature. A setting of 50W energy would be used for RFA and the duration of application is 10 seconds. Sequential applications of up to 7 times per session are allowed for complete ablation of the lesions.
15927886|NCT03435757|Procedure|OFD+IMP+CPS|open flap debridement (OFD) and intramarrow penetration (IMP) plus calcium phosphosilicate putty
15927887|NCT03435757|Procedure|OFD+IMP|open flap debridement (OFD) and intramarrow penetration (IMP)
15927888|NCT03435744|Drug|Simvastatin 20 mg|Simvastatin 20 mg added to TAU for 3 months.
15927889|NCT03435744|Other|Placebo Oral Tablet|Matched placebo added to TAU for 3 months
15927890|NCT03435731|Combination Product|Dual Therapy|Concomitant use of Continuous Positive Airway Pressure (CPAP) and Mandibular Advancement Splint (MAS) therapeutic devices.
15927891|NCT03435718|Drug|Oxfendazole|oral suspension
15927892|NCT03435718|Drug|Albendazole|tablet
15927893|NCT03435705|Behavioral|maintaining of occupational therapy|8 home sessions over a 4 months period with caregivers' education, occupational therapy and care coordination for post intervention
15927894|NCT03435692|Procedure|Lumbar Plexus Catheter|lumbar plexus catheter placed intraoperatively for perioperative pain control
15927895|NCT03435692|Procedure|Lumbar Epidural Catheter|lumbar epidural catheter placed intraoperatively for perioperative pain control
15927896|NCT03435692|Procedure|Patient Controlled Analgesia|A PCA started post operatively for perioperative pain control
15927897|NCT03435692|Drug|Fentanyl|IV fentanyl was administered in the OR for induction of anesthesia. Subsequent doses in the OR were standardized to be given only for heart rate or blood pressure increases > 20% above baseline and occurring more than 30 minutes after the block (if applicable).
15927898|NCT03435692|Drug|Morphine|In the OR patients, IV morphine was administered if patients had a failed block and standardized to be given only for heart rate or blood pressure increases > 20% above baseline and after fentanyl had been administered. IV Morphine was also administered in the OR if the patient was randomized to the PCA arm of the study. Post operatively IV Morphine was administered as needed for severe pain.
15927899|NCT03435692|Drug|Lorazepam|IV Lorazepam was administered PRN for muscle spasm post operatively.
15927900|NCT03435692|Drug|Ondansetron|IV Ondansetron was administered PRN for nausea and vomiting post operatively.
15927901|NCT03435692|Drug|Diphenhydramine|IV Diphenhydramine was administered PRN for itching postoperatively.
15927902|NCT03435692|Drug|Acetaminophen|PO Acetaminophen was administered PRN for pain in the PACU and then scheduled for 72 hours.
15927903|NCT03435692|Drug|Oxycodone|PO Oxycodone was administered PRN for breakthrough pain post operatively.
15927904|NCT03435692|Drug|Ropivacaine|IV Ropivacaine was administered as part of the initial bolus after placement of the lumbar epidural or lumbar plexus catheter and then as a continuous infusion post operatively.
15927905|NCT03435679|Procedure|one-stage|one-stage surgery
15927906|NCT03435679|Procedure|two-stage|two-stage surgery
15927907|NCT03435666|Drug|Capecitabine|Single oral dose (1250mg/m2) Capecitabine or XELODA in each period.
15927908|NCT03435666|Drug|XELODA|Single oral dose (1250mg/m2) Capecitabine or XELODA in each period.
15927909|NCT03435653|Other|OFD with DFDBA|Control Group Open flap debridement with DFDBA Periodontal surgery will be performed in the form of open flap debridement along with placement of demineralized freeze dried bone allograft at the defect site.
15927910|NCT03435653|Other|OFD with decortication and DFDBA|Test Group Open flap debridement with decortication and demineralised freeze dried bone allograft Open flap debridement with decortication and placement of demineralized freeze dried bone allograft at the defect site.
15927911|NCT03435640|Drug|NKTR-262|"During Phase 1 Doublet: Patients will receive escalating doses of NKTR-262 IT (starting dose 0.03 mg) in 3-week treatment cycles. During Phase 1 Doublet (Cohort A), Phase 2 Doublet: Patients will receive the RP2D of NKTR-262.
~During Phase 1 Triplet (Cohort B), and Phase 2 Triplet: Patients will receive the RP2D of NKTR-262."
15927912|NCT03435640|Drug|bempegaldesleukin|"During Phase 1 Doublet (Cohort A), and Phase 2 Doublet: Patients will receive 0.006 mg/kg bempegaldesleukin administered in 3-week treatment cycles.
~During Phase 1 Triplet (Cohort B), and Phase 2 Triplet: Patients will receive 0.006 mg/kg bempegaldesleukin administered in 3-week treatment cycles."
15927913|NCT03435640|Drug|nivolumab|During Phase 1 Triplet (Cohort B), and Phase 2 Triplet: Patients will receive a nivolumab flat dose of 360 mg administered in 3-week treatment cycles.
15927914|NCT03435627|Drug|Somatropin|Participants will be treated with commercially available Norditropin® (somatropin) according to routine clinical practice at the discretion of the treating physician.
15927915|NCT03435614|Drug|Opioids|Once an opioid dose reduction of 10% or greater is achieved, a daily assessment will be conducted by a physician using the DSM-5 criteria for opioid withdrawal. In addition, signs and symptoms of withdrawal will be collected daily by a blinded investigator.
15927916|NCT03435601|Drug|Anifrolumab|"IV Administration of Anifrolumab 300 mg every 4 weeks from week 0 to week 20 for a total of 6 doses.
~At week 24 patients will continue the current study for another 8 weeks to complete a 12-week safety follow-up after the last dose of investigational products (last dose of investigational product will be given at week 20).
~The total study duration could be up to approximately 36 weeks (including the screening period)."
15927917|NCT03435601|Drug|Placebos|"Placebo IV administration Q4W, a total of 6 doses At week 24 patients will continue the current study for another 8 weeks to complete a 12-week safety follow-up after the last dose of investigational products (last dose of investigational product will be given at week 20).
~The total study duration could be up to approximately 36 weeks (including the screening period)."
15927918|NCT03435588|Procedure|EUS|Radial endoscopic ultrasound. A special endoscope uses high-frequency sound waves to produce detailed images of the lining and walls of the digestive tract , and allows to take samples from abnormal areas.
15928007|NCT03434990|Other|Spinal manipulation|The sacroiliac joint will be test and manually verified for any dysfunction, and the lumbar spine will be also assessed to verify any hypomobility and vertebral rotation. The segments with alterations will be manipulated with a high velocity and low amplitude thrust technique.
15927919|NCT03435588|Procedure|FNA with ROSE|Endoscopic ultrasound guided biopsy of the pancreas with the traditional fine needle aspirate needle with the addition of rapid on-site cytopathology (cytopathologist looking at each biopsy samples as they are taken): The sampling is done with a small needle called fine needle aspiration needle or FNA. FNA alone is sometimes limited due to inadequate acquisition of cells for proper diagnosis under the microscope, which can lead to need for repeat endoscopic procedures and delay in diagnosis and possibly treatment. Rapid on-site evaluation of cytopathology (ROSE) is where a cytopathologist is next to the physician doing the endoscopic procedures and evaluates each sampling performed.
15927920|NCT03435588|Procedure|FNB alone|Endoscopic ultrasound guided biopsy with a novel core biopsy needle without on-site cytopathology: New needles called core needles (fine needle biopsy, FNB) have recently been developed which not only acquires cells but also the entire tissue structure (histology).
15927921|NCT03435575|Device|Boosth|Boosth activity tracker which measures steps
15927922|NCT03435562|Other|JUUL electronic cigarette|Effects of JUUL electronic cigarette use.
15927923|NCT03435562|Other|IQOS electronic cigarette|Effects of IQOS electronic cigarette use.
15927924|NCT03435562|Other|Own Brand cigarette|Effects of own brand cigarette use.
15927925|NCT03435549|Behavioral|Remote monitoring|Patients given an activity tracker to wear for 6 weeks after LEJR replacement surgery. For 2 weeks after surgery, they will also receive a daily text messages asking what their pain is on a scale of 0 to 10. They will be asked to reply to the text with their pain score. They will also be sent occasional messaging about their recovery, tips of what to do, and feedback on their progress. They will also also be sent a text message if they stop using their activity tracker for 3 days.
15927926|NCT03435549|Behavioral|Remote monitoring plus goal setting and social support|Patients given activity tracker to wear for 6 weeks after LEJR surgery. For 2 weeks after surgery, they will receive a daily text messages asking what their pain is on a scale of 0 to 10 and asked to reply by text. They will be sent occasional messaging about their recovery, tips of what to do, and feedback on their progress. They will also also be sent a text message if they stop using their activity tracker for 3 days. Patients will be asked to identify a a friend or family member to act as support partner. The study will share progress updates with support partner and contact this individual if patient stops wearing the activity tracker for over 3 days. This partner will also be able to provide supportive messages to help encourage them to reach their activity goals.
15927927|NCT03435536|Other|Blood samples|Blood samples will be taken to analyze the circulating tumor DNA rate by NGS
15927928|NCT03435523|Procedure|Recruitment maneuver|"the ventilator was switched to pressure-control ventilation with a driving pressure of 20 cmH2O. After a 3 min equilibration, PEEP was applied in steps of 5,10,15 and 20 cmH2O every five respiratory breaths; subsequently, after setting a driving pressure of 15 cmH2O, PEEP was stepwise reduced, starting from 15 cmH2O, by 2 cmH2O every 2 minutes. The recruiting pressure of 20/20 was applied for six breaths. During the decremental PEEP trial, CRS was measured at every step. The PEEP level corresponding to highest CRS during the decremental trial was identified as the best PEEP. Subsequently, the lungs were recruited again and the best PEEP was applied."
15927929|NCT03435510|Behavioral|Live Donor Champion Program|Even with adequate education of live donation, many KT candidates still feel ill equipped to ask others to consider donating. Friends and family are often eager to help and may not be able to serve as donors themselves, but might be able to provide substantial instrumental support. An LDC is a friend or family member who serves as an advocate for the candidate in their pursuit of live donation. The Johns Hopkins Comprehensive Transplant Center has developed a 6-month program that provides education and advocacy training to waitlist candidates and their LDCs. The instrumental support provided by the LDC bridges a critical link between education and action.Using LDCs to increase live donation is a novel approach that has garnered widespread enthusiasm.
15927930|NCT03435497|Behavioral|Game Changers|Game Changers is an intervention that aims to empower and mobilize PLHA to be agents for HIV prevention and behavioral change in their social networks.
15927931|NCT03435484|Other|Arm A|Intervention includes various iterations of instructions for completing the Health Assessment Questionnaire. Participants in this group will receive one version (out of two) of instructions for completing the Health Assessment Questionnaire.
15927932|NCT03435484|Other|Arm B|Intervention includes various iterations of instructions for completing the Health Assessment Questionnaire. Participants in this group will receive another version (out of two) of instructions for completing the Health Assessment Questionnaire.
15927933|NCT03435471|Other|Prophylactic Swallowing Home Exercise Program|The home exercise program will consist of six exercises that are recommended to be practiced three times per day. Subjects will complete a weekly exercise log to track compliance.
15927934|NCT03435471|Other|Clinician-Directed Prophylactic Swallowing Exercises|Once weekly face-to-face meetings with a study speech pathologist for a total of six sessions, to participate in active swallowing exercises
15927935|NCT03435458|Combination Product|Balloon catheter + oral misoprostol|The pharmacological cervical ripening will be administered just after the balloon catheter insertion (after coming back in her room) and will consist of misoprostol 25 micrograms given orally (oral prostaglandin E1). The same dose will be given every 2 hours until beginning of labor with a maximum of 8 administrations.
15927936|NCT03435458|Drug|Oral misoprostol alone|Patients will receive a pharmacological cervical ripening alone that consist of Misoprostol 25 micrograms given orally (oral prostaglandin E1). The same dose will be given every 2 hours until beginning of labor with a maximum of 8 administrations.
15927937|NCT03435445|Behavioral|Online platform group|The online platform has social network, gamification and short-text sessions.
15927938|NCT03435445|Behavioral|Online dietitian coaching|Dietitian coaching refers to individual online sessions between a dietitian and participants to strengthen dietary recommendations
15927939|NCT03435445|Behavioral|Control group|Minimal intervention with four videos with diet, physical activity and behavior change recommendations
15927940|NCT03435432|Dietary Supplement|Glucose|Glucose drink
15927941|NCT03435432|Dietary Supplement|Water|Control
15927942|NCT03435419|Diagnostic Test|LoopampTM Leishmania Detection Kit|LoopampTM Leishmania Detection Kit is a diagnostic test for Leishmania DNA detection
15927943|NCT03435419|Diagnostic Test|CL DetectTM Rapid Test|CL DetectTM Rapid Test is a diagnostic test for Leishmania antigen detection
15927944|NCT03435393|Procedure|Catheter ablation|Mapping of the epicardium and ablating areas of long fractionated potentials
15927945|NCT03435380|Behavioral|Patient activation|Smartphone-based materials including text messages and supplemental short videos focusing on how to find a primary care doctor, the importance of medical screening, and how to talk to a doctor about medical screening. Guidelines for monitoring and maintaining health, such as a survivorship care plan, will also be included in the smartphone-based materials.
15927946|NCT03435380|Behavioral|Primary care physician activation|Mailed educational print materials sent to the participants' primary care doctors about health risks and recommendations for medical screening for adult women who were treated for a childhood cancer with chest radiation.
15927947|NCT03435380|Behavioral|Control|Mailed educational materials.
15927948|NCT03435367|Device|Virtual Reality Program|VR with head mounted display (HMD) and headphones.
15927949|NCT03435367|Device|iPad Tablet|iPad with headphones
15927950|NCT03435354|Behavioral|Physical activity counselling|Clinician counselling about physical activity using standardized tools to promote daily physical activity.
15927951|NCT03435328|Device|TENS|"Duration of stimulation: 5 minutes.
~Frequency: will be fixed at 50 Hertz.
~Pulse duration: 250 µs.
~Intensity: optimal intensity of TENS (amplitude will be gradually increased to the maximum intensity that the subject will be comfortable and tolerate it).
~Sessions: only one session"
15927952|NCT03435315|Other|Treadmill Exercise- behavioral approach|16-session, 8-week treadmill exercise program utilizing behavioral techniques while walking
15927953|NCT03435315|Other|Treadmill Exercise- traditional approach|16-session, 8-week traditional treadmill exercise program
15927954|NCT03435302|Drug|Temozolomide Plus Cisplatin|"Temozolomide is the oral analog of dacarbazine (DTIC), shows potential advantages over dacarbazine.
~Cisplatin is an agent that can potentially enhance the activity of temozolomide."
15927955|NCT03435302|Drug|High-Dose IFN-a2b|Interferon belongs to the large class of glycoproteins known as cytokines.
15927956|NCT03435289|Drug|CPI 613 in Combination With Gemcitabine and Nab-paclitaxel|"Day 1,15 CPI-613: IV infusion at a rate of 4 mL/min via a central venous catheter starting at 500 mg/m2 (with concurrent D5W infusing at a rate of 125-150 cc/hr). The CPI dose will be determined based on cohort. Day 2,16 Neulasta as clinically indicated
~Nab- paclitaxel 125mg/m2 iv over 30 min followed by Gemcitabine 1000mg/m2 iv over 30 min"
15927957|NCT03435276|Drug|AZD9977|Randomized subjects will receive AZD9977 oral suspension at a dose of 50 mg in Cohort 1, 150 mg in Cohort 2 and 300 mg in Cohort 3
15927958|NCT03435276|Other|Placebo|Randomized subjects will receive orally AZD9977 matched placebo in Cohorts 1, 2 and 3
15927959|NCT03435263|Other|home management|pregnant women presented with PROM will be randomized into 2 groups group a will be discharged home after initial assessment and group B will be admitted to hospital as usual
15927960|NCT03435250|Drug|AG-270|AG-270, orally, once or twice daily, on Days 1 through 28 of each 28-day cycle, until disease progression or unacceptable toxicity.
15927961|NCT03435250|Drug|AG-270|AG-270, orally, once or twice daily, for 1 week prior to the first dose of docetaxel. Thereafter, AG-270 continues to be given daily, on Days 1 through 21 of each 21-day cycle, until disease progression or unacceptable toxicity.
15927962|NCT03435250|Drug|AG-270|AG-270, orally, once or twice daily for 1 week prior to the first doses of nab-paclitaxel and gemcitabine. Thereafter, AG-270 continues to be given daily on Days 1 through 28 of each 28-day cycle, until disease progression or unacceptable toxicity.
15927963|NCT03435250|Drug|docetaxel|Docetaxel, IV, once during each 21-day cycle, until disease progression or unacceptable toxicity.
15927964|NCT03435250|Drug|nab-paclitaxel|Nab-paclitaxel, IV, on Days 1, 8, and 15 of each 28-day cycle, until disease progression or unacceptable toxicity.
15927965|NCT03435250|Drug|gemcitabine|Gemcitabine, IV, on Days 1, 8, and 15 of each 28-day cycle, until disease progression or unacceptable toxicity.
15927966|NCT03435224|Device|INVSENSOR00012|Noninvasive pulse oximeter sensor
15927967|NCT03435211|Device|INVSENSOR00006|Noninvasive pulse oximeter sensor
15927968|NCT03435198|Diagnostic Test|Collect exhaled breath during low and normal blood sugar|Collect exhaled breath during low and normal blood sugar to determine if there are any differences between the two in people with type 1 diabetes.
15927969|NCT03435185|Procedure|Lidocaine injections|Lidocaine injections. A mixture of 1 ml 2% lidocaine and 0.9% 1 ml saline was injected bilaterally to greater occipital nerve and supraorbital nerve in the blockade patients.
15927970|NCT03435185|Procedure|Saline injections|Saline injections. Patients received 2 ml 0.9% saline in bilaterally to greater occipital nerve and supraorbital nerve
15927971|NCT03435172|Device|Device-ADRCs intravenously infusion|Medical Device: ADRCs Generated by Celution 800 IV Device and then Infused into Peripheral Vein.
15927972|NCT03435159|Diagnostic Test|Doppler Ultrasonography|GE LOGIQ S8 ultrasound machine was used to measure blood flow parameters in right and left a. carotis communis, a. carotis interna and a. vertebralis. All vessels were examined in the axial plane through their traces in the B-mode with a C6-15 MHz curvilinear matrix probe. Flow patterns and directions of vessels were then examined with Colour Doppler and it was determined whether there was any stenosis. Intimal thickness of a. carotis communis was measured by spectral doppler method. Measurements were recorded by visualizing the CCA at the supraclavicular level, the ICA carotid sinus (C4 level), and the VA at the V2 segment (C3-4 level), with less angle at 60 degrees. All measurements before and after the application were made at the same level. Immediately after manipulation, blood flow parameters were recorded as numerical data by the same physician again with Doppler USG of the relevant arteries.
15927973|NCT03435159|Procedure|Manual Chiropractic Spinal Manipulation|"Manipulation procedures were applied to C1 or C2 (atlas and axis) vertebrae once in each participant. The application to which vertebrae were applied was determined by the palpation method applied by the physiotherapist. Manual chiropractic manipulation for C1 vertebra was applied in sitting position, using the digit / atlas pull technique. This technique is applied with the contact of practitioner's middle finger to the posterior part of transverse process of atlas, and generate a rotation force between C1 and C2 vertebrae.
~The procedure was applied to C2 vertebra using the index / facet push technique in the supine position. This technique places pushing force in the direction of rotation between the C2-C3 vertebrae, placing the practitioner's index finger in contact with the posterior surface of the C2 facet joint."
15928008|NCT03434977|Drug|TAK-536|TAK-536 granule formulation
15928112|NCT03434197|Drug|Esflurbiprofen|A plaster containing 40 mg of Esflurbiprofen and 36.2 mg of Japanese Pharmacopoeia mentha oil per patch (10 × 14 cm)
15927974|NCT03435159|Device|Instrumental Chiropractic Spinal Manipulation|"Activator technique was applied to C1 or C2 (atlas and axis) vertebrae once in each participant. The application to which vertebrae were applied was determined by the palpation method applied by the physiotherapist. Instrumental spinal manipulation was applied with Activator V chiropractic instrument. For C1 vertebra, the procedure was applied in supine position, by placing the Activator device horizontally on the participant's atlas transverse process of the affected side and applying a pushing force in the medial direction.
~For C2 vertebra, the procedure was applied in prone position, by placing the Activator device in the relevant C2 pedicle-lamina junction of the participant's affected side and applying a pushing force in the anterior, superior and mild medial direction of movement of the facet joint."
15927975|NCT03435146|Combination Product|3HP plus DTG +2NRTIs|"HIV treatment: DTG will be dosed as described above and will be given with daily TDF/FTC (Groups 1 and 2) or with TDF/3TC (Groups 3 and 4).
~LTBI treatment: 3HP will be given once-weekly for a total of 12 doses, with doses as follows:
~Rifapentine: 900 mg; Isoniazid: 900 mg (Groups 1,2 and 4) Isoniazid at standard of care dosing (Group 3)"
15927976|NCT03435133|Drug|Prasugrel|60 mg oral bolus plus oral 10 mg once daily
15927977|NCT03435133|Drug|Ticagrelor|180 mg oral bolus plus oral 90 mg every 12 hours daily
15927978|NCT03435120|Other|No intervention|No intervention
15927979|NCT03435107|Drug|Durvalumab|"Study treatment consists of durvalumab 1500 mg Q4W for patients > 30 kg, and will be repeated every 4 weeks. For patients ≤ 30 kg, weight based dosing of 20 mg/kg durvalumab Q4W will be used.
~Response evaluation will be performed every 8 weeks (± 1-week window period). Treatment will be continued until disease progression, unacceptable adverse events or the patient's refusal.
~Treatment through progression is at the investigator's discretion, and the investigator should ensure that patients do not have any significant, unacceptable, or irreversible toxicity that indicate that continuing treatment will not further benefit the patient. The Investigator should ensure that patients still meet all of the inclusion criteria and none of the exclusion criteria for this study."
15927980|NCT03435094|Drug|Binosto 70Mg Effervescent Tablet|Assess the effect of alendronate 70mg effervescent tablet on bone turnover markers and patient reported outcomes.
15927981|NCT03435094|Drug|Fosamax 70Mg Tablet|Assess the effect of alendronate 70mg tablet on bone turnover markers and patient reported outcomes.
15927982|NCT03435081|Drug|Baricitinib|Administered orally
15927983|NCT03435081|Drug|Placebo|Administered orally
15927984|NCT03435068|Device|Ceramic rotary bur|Gingivoplasties were performed with the same ceramic burs to easily provide a knife-edge appearance with ceramic rotary bur
15927985|NCT03435068|Device|Diode laser|The fiber optic laser tip had a 320-μm diameter with a 2.8 W output power were used in the study.
15927986|NCT03435068|Device|Scalpel|Scalpel surgery were performed as control group (conventioanl group).
15927987|NCT03435055|Drug|Nitrous Oxide Gas for Inhalation|Each volunteer will participate in one scanning visit in which simultaneous functional magnetic resonance imaging (fMRI) and electroencephalogram (EEG) data will be collected wherein they receive placebo (20 minutes) followed by inhaled nitrous oxide at subanesthetic levels (35% inhaled concentration) over 40 minutes.
15927988|NCT03435042|Behavioral|Self care + Hypnosis group|Our groupal intervention is divided into 6 monthly 2-hour sessions in which some self-hypnosis exercises are proposed to participants. Self-care techniques are also discussed (knowing our own needs, self-respect, assertiveness, coping with ruminations...) and homework assignments are proposed to participants, in order to foster positive change.
15927989|NCT03435029|Behavioral|Cognitive Remediation Program (REHACOP)|The REHACOP group received cognitive remediation sessions 3 times per week for 3 months in 60 minute per session. The rehabilitation consisted of 39 sessions divided into: attention and concentration unit (sustained, selective, alternating, and divided attention) 4 weeks; learning and memory unit (verbal and visual memory and learning strategies) 3 weeks; language (verbal fluency, syntax, grammar, vocabulary, and comprehension) 3 weeks; and executive functioning (objectives planning and attainment, verbal reasoning, categorization, and conceptualization). In addition, processing speed was trained transversely during all the sessions.
15927990|NCT03435029|Other|Occupational Therapy|The control group received occupational group activities (reading the newspaper, drawing, singing or doing crafts) with the same frequency and format as the experimental group.
15927991|NCT03435016|Diagnostic Test|Diagnostic work-up|Patients are examined with all modalities. MR enterocolonography, ultrasound, and small bowel capsule endoscopy are compared against ileocolonoscopy (gold standard).
15927992|NCT03435003|Drug|Aprepitant 80Mg Oral Capsule|aprepitant 80 mg orally one hour prior to scheduled surgery
15927993|NCT03435003|Drug|scopolamine transdermal|scopolamine transdermal patch one hour prior to scheduled surgery
15927994|NCT03435003|Procedure|Total intravenous anesthesia|Maintenance of anesthesia without the use of inhaled anesthetics.
15927995|NCT03435003|Drug|Dexamethasone|Dexamethasone 8 mg intraoperatively
15927996|NCT03435003|Drug|Ondansetron|Ondansetron 4 mg intraoperatively. Ondansetron will be given twice. Once intraoperatively and then post- operatively.
15927997|NCT03435003|Drug|Reglan|Postoperatively scheduled Reglan
15927998|NCT03435003|Drug|Ondansetron|Postoperatively scheduled ondansetron
15927999|NCT03435003|Drug|Compazine|Postoperatively as needed compazine for breakthrough PONV
15928000|NCT03435003|Drug|Sugammadex|Reversal with sugammadex
15928001|NCT03435003|Drug|Propofol|Intravenous anesthesuia will be maintained through IV propofol
15928002|NCT03435003|Drug|dexmedetomidine|maintainance of anesthesia in the intervention arm
15928003|NCT03435003|Drug|Fentanyl|intermittent bolus dosing of fentanyl will be used after induction for anesthesia maintenance
15928004|NCT03435003|Drug|Sevoflurane|inhalational anesthesia
15928005|NCT03435003|Drug|Desflurane|inhalational anesthesia
15928006|NCT03434990|Other|Spinal manipulation/myofascial release|The protocol will be composed by myofascial release followed by spinal manipulation. Paravertebral muscles and gluteus maximus and piriform muscles will be manually checked for tension, stiffness, spasm and painful points. The intervention will be composed by: trigger points release, release of muscle fascia and active release technique. The myofacial release will be done with a constant pressure during 30 seconds, 3x in each point. After this procedure, the spinal manipulation will be performed in high velocity and low amplitude thrust technique, on the lumbar spine and sacroiliac joint.
15928042|NCT03434704|Procedure|PBSC graft|(target 4-8 × 106 CD34+ cells/kg patient body weight)
15928009|NCT03434964|Diagnostic Test|the intraoperative effectiveness of the AIFIB software in real time in the detection of atrial fibrillation drivers during an ablation procedure.|Real-time validation by an expert operator of the correct detection of atrial fibrillation driver
15928010|NCT03434951|Drug|Bupivacaine Hydrochloride, Spinal|Intrathecally administered 12,5mg bupivacaine for spinal anaesthesia
15928011|NCT03434951|Drug|Morphine hydrochloride, Spinal|Intrathecally administered morphine 0,2mg (2mg/ml, 0,1ml)
15928012|NCT03434951|Drug|Placebo - Concentrate|Intrathecally administered saline solution 0,9% 0,1ml to match morphine volume
15928013|NCT03434938|Behavioral|Motivational interviewing|"MI sessions' goals will to obtain patients' collaboration, creating a shared tailored approach to complement the individual geriatric rehabilitation plan, and reinforcing engagement and adherence at 3 months.
~All 20-minutes sessions will follow the logical sequence of MI by Rollnick and Millner (engaging, focusing, evoking and planning) in a semi-structured format to ensure homogeneity. Content will include: 1) Creating engagement with patients by exploring their preferences, values, goals, and their knowledge and expectations about rehabilitation and recovery, 2) enhancing motivation by evoking patients' strengths and abilities, 3) follow-up and reinforcement, and 4) adapting the plan to the improved abilities and to home setting after discharge."
15928014|NCT03434925|Genetic|Multi-targeted next generation sequencing|Study directed at finding molecular predictors of recurrent colorectal adenomas also taking into account the intrinsic level of heterogenity imprinted in the internal differences in molecular profiles
15928015|NCT03434899|Behavioral|Physical exercise and online support|Person-centered design of a health care plan including individually adjusted physical exercise. Online support for management of health care plan.
15928016|NCT03434899|Behavioral|Physical exercise|Person-centered design of health care plan individually adjusted physical exercise.
15928017|NCT03434886|Other|CFView|Registry patient portal
15928018|NCT03434886|Other|CF educational videos|CF educational videos
15928019|NCT03434873|Other|magnetic stimulation|Twenty trains of 50 stimuli at 5 Hz (train duration: 10 seconds) separated by a 40-second pause were delivered for a total of 1000 pulses, once a day for four consecutive days for two weeks
15928020|NCT03434860|Dietary Supplement|probiotic|"The multiprobiotic Symbiter which contains of 14 alive probiotic strains of Lactobacillus + Lactococcus (6×1010 CFU/g), Bifidobacterium (1×1010/g), Propionibacterium (3×1010/g), Acetobacter (1×106/g) genera. Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) of probiotic per day."
15928021|NCT03434860|Dietary Supplement|placebo|Over 8 weeks of interventional period, the patient received 1 sachet (10 grams) of gel per day
15928022|NCT03434847|Other|Education|Participants who receive perioperative educational to address their expectation about their postoperative pain will have improved pain-related postoperative outcomes.
15928023|NCT03434834|Device|optical coherence tomography|OCT measurements of 5 locations in the esophagus
15928024|NCT03434808|Other|Whole Blood Donation|Study subjects will provide 250ml whole blood donation for the manufacture and banking of iPS cells.
15928025|NCT03434782|Drug|In-office dental bleaching|The group will receive in-office bleaching treatment. Three 15-minute applications of the 35% hydrogen peroxide gel were performed, totaling 45 minutes in each of the 3 sessions, with a 7-day interval.
15928026|NCT03434782|Drug|Low Level Laser Therapy|It will be used the infrared spectrum with wavelength of 808 nm in its active environment AsGaAl, in two points: cervical and apical region of the incisors, canines and premolars.
15928027|NCT03434782|Drug|5% potassium nitrate / 2% sodium fluoride gel|5% potassium nitrate / 2% sodium fluoride gel will be applied for 10 minutes on the vestibular surface of all pre-bleached dental elements, following the manufacturer's protocol.
15928028|NCT03434769|Drug|Cyclophosphamide|Cyclophosphamide 60mg/Kg on day -6
15928029|NCT03434769|Drug|Fludarabine|Fludarabine 25mg/m^2 IV on days -5 to -3
15928030|NCT03434769|Biological|CAR-T Cells|"Chimeric antigen receptor T cells to be implemented in a 3 + 3 design on day 0
~Level -1 (1 x 105 cells/kg)
~Level 1 [Starting dose] (5 x 105 cells/kg)
~Level 2 (1 x 106 cells/kg)
~Level 3 (2 x 106 cells/kg)"
15928031|NCT03434756|Other|Propioceptive training of the abdominal wall muscles|At the beginning, patients will be in a supine position, the lower edge of the StabilizerTM will be placed between the posterior superior iliac spines, aligned with the sacral base. Abdominal manoeuvre will be developed by the patients until they reach 40 mmHg and hold steadily for 10 seconds. Prior the examination, each subject practiced the abdominal manoeuvre three times with an ultrasound image feedback.
15928032|NCT03434743|Other|Rehabilitative|Non-nutritive sucking on emptied breast
15928033|NCT03434743|Other|Active Comparator|Non-nutritive sucking on pacifier
15928034|NCT03434730|Radiation|Total Body Irradiation|Participants will receive a total dose of 400 cGy on day -2 and day -1 as 2 fractions (200 cGy x 2). Participants receiving total body irradiation (TBI) are treated in a standing position, and the treatment takes about 20 to 30 minutes.
15928035|NCT03434730|Drug|Cyclosporine|Dilute in D5W or NS to make a 2.5 mg/ ml solution. Infuse slowly over approximately 1-4 hours (intermittent infusion) or 24 hours for continuous infusion.
15928036|NCT03434730|Drug|Mycophenolate Mofetil|A 1000 mg dose should be placed in 140 ml of D5W. Administer only with D5W, over at least 2 hours.
15928037|NCT03434730|Drug|Tocilizumab|For participants < 30kg, dilute with 50mL 0.9% sodium chloride. For participants ≥ 30kg, dilute to 100ml with 0.9% sodium chloride. Administer infusion over 60 minutes with infusion set.
15928038|NCT03434730|Drug|Filgrastim|The single use prefilled syringes contain either 300 mcg or 480 mcg Filgrastim at a fill volume of 0.5 mL or 0.8 mL, respectively. For the prevention/treatment of chemotherapy induced neutropenia, the dose of filgrastim is standardized per body weight: ≤ 60 kg = 300 mcg daily subcutaneously; > 60 kg = 480 mcg subcutaneously daily.
15928039|NCT03434717|Other|Individualised rehabilitation|Patients will get access/support to individualised rehabilitation based on their needs identified through the distress thermometer
15928040|NCT03434717|Other|Care as usual|Patients will get care as usual
15928041|NCT03434704|Drug|"Conditioning treatment Thiotepa-Treosulfan-Fludarabine"|Thiotepa iv 5 mg/kg/bid (total dose TD 10 mg/kg) day -3,-2; Treosulfan iv 14g/mq/day (TD 42 g/mq) as a single daily dose day -6, -5, -4; Fludarabine iv 30 mg/m2 (TD 150 mg/m2) day -6, -5, -4, -3, -2. Thiotepa TD 5 mg/kg and treosulfan TD 36 g/mq dose reduction according to age > 65 years.
15960986|NCT03181100|Biological|Bevacizumab|Given IV
15928043|NCT03434704|Drug|GvHD prophylaxis|"Sirolimus orally, monitored two times a week to maintain a target therapeutic plasma level of 8-15 ng/ml from day +5.
~Mycophenolate 15 mg/kg bid i.v. or per os day +5 through +28. Cyclophosphamide 50 mg/kg i.v. day +3+4. Mesna: >80% of the cyclophosphamide dose in 3 divided doses from day +3 daily through day +5."
15928044|NCT03434704|Drug|Primary antifungal prophylaxis|Posaconazole delayed-release tablet [available in 100 mg tablets]: 300 mg twice daily on the first day followed by a maintenance dose of 300 mg once a day, starting on the day 0 to day 85.
15928045|NCT03434691|Device|Microdialysis Probe (Muscle microdialysis)|"Interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were determined at baseline and then every six hours for the following 72 hours after randomization.
~During the study period, conventional treatment was continued as per usual practice. Fluid challenges were performed, and repeated as necessary, to maintain central venous pressure (CVP) ≥8 and pulmonary arterial occlusion pressure (PAOP) ≥12 mmHg. Norepinephrine was titrated to maintain mean arterial pressure (MAP) ≥65 mmHg. Packed red blood cells were transfused when Hemoglobin (Hb) concentrations decreased below 7 g/dL, or if the patient exhibited clinical signs of inadequate systemic oxygen supply."
15928046|NCT03434691|Drug|remifentanyl|Only the dose of remifentanyl (initial infusion of 6 µg/kg/h) can be changed to achieve a Goal of sedation: Richmond agitation-sedation scale 0 to -2.
15928047|NCT03434678|Drug|Propofol+ Rocuronium+ Fentanyl 2 mcg/kg+ Inhalational Agent, Bupivacaine 0.125% + Fentanyl 5 mcg/ml|Patient will have their epidural started at the beginning of the surgery and receive fewer opioid drugs. The epidural is continued into the recovery room.
15928048|NCT03434678|Drug|Propofol+ Rocuronium+ Fentanyl + Inhalational|Patient will have the standard intraoperative management during surgery and have the epidural started just before being taken to the recovery room.
15928049|NCT03434678|Procedure|Open Pancreaticoduodenectomy|Whipple' Procedure
15928050|NCT03434665|Procedure|Transradial celiac artery angiography|"After completion of transradial diagnostic coronary angiography and/or PCI, before removal of the radial arterial sheath, selective angiography of the celiac artery will be performed.
~Technically, a 0.35-inch wire is advanced into the descending aorta. A 125 cm 5-French Judkins right catheter is inserted over this wire, which is then removed. The distal tip of the catheter is brought in front of the ostium of the celiac artery and positioning is confirmed with angiography of the celiac artery. Two or three views will be obtained to determine the optimal view to visualize the left gastric artery anatomy. All material is removed and hemostasis is obtained as per clinical routine for coronary angiography."
15928051|NCT03434652|Device|Percutaneous neurostimulation|Auricular percutaneous neurostimulation
15928052|NCT03434639|Diagnostic Test|Spectroscopic gut permeability test|"The spectroscopic gut permeability test first involves patients receiving an oral dose of one or more fluorescent dyes. A wearable sensor will then be attached to the patients' skin and this will be used to monitor the leakage of the fluorescent dyes from the intestine into the blood stream in a non-invasive manner. In this way, a measure of the permeability of the intestine will be obtained.
~Note that patients in Group 1 (ophthalmology patients) will not receive oral doses of contrast agents. Instead, the wearable sensor will simply be used to detect the presence of fluorescent dyes that were administered intravenously as part of planned ophthalmic procedures.
~Complete details of the spectroscopic gut permeability test can be found in the attached protocol."
15928053|NCT03434626|Behavioral|ACP Education|Decision aid and Goals of Care Designation form information administered by Navigator
15928054|NCT03434626|Other|Usual care|Usual care includes reviewing Goals of Care Designation form and Greensleeve with physician
15928055|NCT03434613|Drug|Rosuvastatin|Rosuvastatin 5mg 1T daily for 6 months
15928056|NCT03434613|Drug|Rosuvastatin/ezetimibe combination|Rosuvastatin 5mg / Ezetimibe 10mg combination 1T daily for 6 months
15928057|NCT03434600|Other|Oxford UKA vs Sigma UKA|
15928058|NCT03434587|Procedure|Syndactyly|Syndactyly
15928059|NCT03434587|Procedure|Reduction and inmobilization|Closed reduction and inmobilization with splint
15928060|NCT03434574|Dietary Supplement|Placebo|Identical formulation as the treatment consisting of colored maltodextrin using artificial colors.
15928061|NCT03434574|Dietary Supplement|Aronia extract|Powdered extract obtained from aronia berries (Aronia melanocarpa).
15928062|NCT03434535|Device|Technology Intervention|A combination of existing technology and a new app developed by InHealth Measurement Corp to (1) remotely monitor a participant's activity level and weight and (2) remotely provide updates to the participants regarding their progress towards the goals established in the Prostate Cancer Foundation Health and Wellness guidelines.
15928063|NCT03434522|Device|vBloc Maestro Rechargeable System|vBloc therapy consists of a neuromodulation device that delivers intermittent, controllable electrical blocking algorithms, to the intra-abdominal vagus nerve for the treatment of obesity.
15928064|NCT03434509|Other|Continuous Tai Chi and Mindful Movement classes|"Participants will be enrolled in ongoing Tai Chi and mindful movement classes throughout the year, for 1 hour twice a week.
~Class sessions will consist of warm up (yoga- and mindfulness-based practices), postural and breathing exercises, Tai Chi form practice, and Tai Chi games (including push hands).
~Children on stimulant medications will remain on these medications during the training period (though they will be asked to stop medications one day prior to motor and cognitive testing)."
15928065|NCT03434496|Device|Gait Trainer 3|With the BIODEX Gait Trainer 3, patients acquire a smooth gait pattern. In addition, balance, coordination, endurance and the cardiovascular system are trained. Work on the treadmill strengthens the leg muscles. On the screen or via an audio message, the patients and therapists receive direct feedback on the smoothness of the gait pattern. The therapists can then make corrective interventions if necessary and the patients are motivated.
15928066|NCT03434483|Procedure|Assessment of the atherosclerotic plaque in a moderate lession.|"In patients who have been successfully revascularized the artery responsible for AMI and also present an intermediate lesion (40-80%) in another coronary territory, the clinical care protocol of the Cardiology Service stipulates the need for a physiological assessment with guidance of pressure (FFR).
~The thickness of the fibrous cap shall be measured using optical coherence tomography.
~In addition to the FFR measurement, a complete physiological assessment with a Doppler-pressure guide. This will allow the procedure to be performed without additional risk to the patient. The physiological study will include the analysis of endothelium-dependent vascular function and endothelium-independent vascular function."
15928249|NCT03433079|Diagnostic Test|Procalcitonin (PCT)|The level of procalcitonin (PCT) was assessed in all patients.
15928067|NCT03434483|Genetic|Gene variants in atherosclerosis|From the blood samples of the patients, the total DNA will be extracted and the main functional variants identified in the literature will be genotyped
15928068|NCT03434483|Other|Microbiota analysis|From the samples of blood, feces, oral cavity and blood, the DNA of the microbiota will be extracted using specific extraction kits and the microbiome will be analyzed through the study of 16S ribosomal RNA amplicons.
15928069|NCT03434483|Other|Immunological analysis|A study of immunological cell populations and cytokines will be carried out from fresh blood samples using antibody panels and flow cytometry
15928070|NCT03434483|Other|Clinical evaluation|Clinical evaluation including hemostasis and biochemical studies and questionaries for diet and exercice registration
15928071|NCT03434444|Drug|Oxytocin|Oxytocin in solution, ranging from 10 -12M to 10 -5M
15928072|NCT03434444|Drug|Propranolol|Propranolol in solution, 10-6M
15928073|NCT03434431|Other|Reverse dieting|
15928074|NCT03434418|Drug|osimertinib|80 mg oral administration daily
15928075|NCT03434405|Behavioral|SocialMind|SocialMind is a mindfulness-based intervention including elements such as radical acceptance, decentering or meditation-techniques. It is designed to target social cognition, defined as the ability to recognize, understand and benefit from social stimuli.
15928076|NCT03434405|Behavioral|Psychosocial treatment|Treatment as usual delivered by patient's practitioner
15928077|NCT03434405|Drug|Psychotropic treatment|Treatment as usual delivered by patient's practitioner
15928078|NCT03434392|Diagnostic Test|Quantitative Sensory Test 1|Subject will give pain rating (on Visual Analogue Scale (VAS) 0-10) of single as well as multiple stimulation with round-tip non-invasive pin-prick device. Difference is recorded as Temporal Summation Score.
15928079|NCT03434392|Diagnostic Test|Quantitative Sensory Test 2|Subject will state when they first detect pain and pain detection threshold in response to pressure administration with pressure algometer. Pressure threshold recorded in kilopascals(kP). Stimulation will be repeated in pancreatic and control dermatomes. Subject will then state pain tolerance threshold at same locations. Sensitization will be characterized by ratio of pancreatic vs. control dermatome scores.
15928080|NCT03434392|Diagnostic Test|Quantitative Sensory Test 3|Subject will apply dominant hand to ice-chilled water bath (36F) for up to 2 minutes. Pain score (VAS 0-10) will be assessed each 10 seconds. Pain tolerance threshold (in kP) will be assessed with algometer on non-dominant thigh before and after water bath to determine change in threshold. Difference in pain tolerance recorded as Conditioned Pain Modulation Score.
15928081|NCT03434379|Drug|Atezolizumab|Atezolizumab will be administered by IV, 1200 mg on day 1 of each 21 day cycle
15928082|NCT03434379|Drug|Bevacizumab|Bevacizumab will be administered by IV, 15 mg/kg on day 1 of each 21 day cycle
15928083|NCT03434379|Drug|Sorafenib|Sorafenib will be administered by mouth, 400 mg twice per day, on days 1-21 of each 21-day cycle
15928084|NCT03434366|Drug|ketamine and dexmedetomidine|intranasal ketamine and dexmedetomidine for treatment for autism spectrum disorder
15928085|NCT03434366|Drug|ketamine|intranasal ketamine for treatment for autism spectrum disorder
15928086|NCT03434366|Drug|Saline|intranasal saline for treatment for autism spectrum disorder
15928087|NCT03434353|Drug|Inarigivir Soproxil|Administered orally once daily one hour before or one hour after a meal
15928088|NCT03434353|Drug|TAF|25 mg tablet administered orally once daily with food
15928089|NCT03434340|Biological|Peppermint essential oil|2 drops applied on a nasal strip
15928090|NCT03434340|Drug|Granisetron|1mg intravenous injection
15928091|NCT03434340|Drug|Dexamethasone|4mg intravenous injection
15928092|NCT03434327|Other|Strength Training|Eleven resistance training exercises performed on pneumatic resistance training machines using 2 second concentric and 3 second eccentric contractions at 75-80% of each subjects maximal strength. Subjects will perform 3 sets per exercise, two times per week for 12 weeks.
15928093|NCT03434327|Other|Power Training|Eleven resistance training exercises performed on pneumatic resistance training machines using maximum speed concentric and 3 second eccentric contractions at the load that produces the highest power for the individual. Subjects will perform 3 sets per exercise, two times per week for 12 weeks.
15928094|NCT03434314|Procedure|Minimally-Invasive Segmental Artery Coil-Embolization|During one single MISACE session 3-7 segmental arteries will be occluded. The procedure is conducted through a peripheral artery access in local anaesthesia. Microcoils or vascular plugs will be used for the occlusion itself.
15928095|NCT03434301|Device|ReliaTack™|Absorbable tack (ReliaTack™) to fixate Symbotex™ composite mesh in the elective repair of incisional hernia.
15928096|NCT03434301|Device|Protack™|Non-absorbable tack (Protack™) to fixate Symbotex™ composite mesh in the elective repair of incisional hernia.
15928097|NCT03434288|Other|Bone sampling|Bone biopsy in Diabetic patients with foot osteomyelitis
15928098|NCT03434275|Drug|N1539|Once Daily
15928099|NCT03434275|Drug|Placebo|Once Daily
15928100|NCT03434262|Drug|Gemcitabine|Given intravenously (IV).
15928101|NCT03434262|Drug|ribociclib|Given orally (PO).
15928102|NCT03434262|Drug|sonidegib|Given PO.
15928103|NCT03434262|Drug|trametinib|Given PO.
15928104|NCT03434262|Biological|filgrastim|Given subcutaneously (SQ).
15928105|NCT03434249|Dietary Supplement|Bifidobacterium, BB-12® (Bifidolactis Infant)|
15928106|NCT03434249|Dietary Supplement|Bifidolactis Infant Placebo|
15928107|NCT03434236|Dietary Supplement|low dose Lipinova (30 mL daily)|Lipinova is a nutritional supplement containing concentrated n-3 PUFA (EPA and DHA) and metabolites
15928108|NCT03434236|Dietary Supplement|Placebo|Placebo will have a similar appearance, smell and taste as the nutritional supplement
15928109|NCT03434236|Dietary Supplement|high dose Lipinova (60mL)|Lipinova is a nutritional supplement containing concentrated n-3 PUFA (EPA and DHA) and metabolites
15928110|NCT03434210|Other|LAT-treated Community Model|The subjects in experimental group is on 'LAT-treated Community Model'. which means,beside care as usual, subjects will be treated by paliperidone palmitate, Psychiatrists will guide community mental health professinals about the treatment and management. Psychiatrists will give community mental health professinals and patients/ caregiver long acting injection related education information.
15928111|NCT03434210|Other|care as usual|Control group will get usual community care, the treatment is identified by doctors, patients and care-giver as usual.
15928113|NCT03434197|Drug|Diclofenac diethylamine|A gel containing 11.6 mg of Diclofenac diethylamine (equivalent to 10 mg of diclofenac sodium) per 1 g (1 tube contains 20 g)
15928114|NCT03434171|Behavioral|Aerobic excercise|practiced treadmill exercise program for 30 minutes at 60% to 70% of maximum heart rate. The treatment sessions will be repeated 3 times per week for 12 weeks
15928115|NCT03434171|Dietary Supplement|soy products|diet modification contains soy products (phytoestrogen) such as soy milk and soy beans every day for 12 weeks only
15928116|NCT03434158|Drug|Olaparib|300 mg twice a day
15928117|NCT03434145|Other|ophthalmologic exams|ophthalmologic exams such as vision, intraocular pressure, axial length and optical coherence tomography
15928118|NCT03434132|Procedure|Open or robotic radical cystectomy|"ORC and orthotopic ileal neobladder is performed as previously described. A separate package PLND is performed as in open as in robotic surgery. RARC is performed replicating open surgical procedure.
~The orthotopic ileal neobladder model used is the 'vescica ileale padovana' as previously described. An ileal segment, approximately 42 cm long, is chosen at a minimum distance of 20cm far from ileo-cecal valve. A latero-lateral ileal anastomosis is performed with staplers to restore bowel continuity.
~For ileal conduit, a 20cm ileal segment (approximately 20 cm long) at a minimum distance of 20 cm from ileo-cecal valve is isolated and transected with staplers. Bowel continuity is restored as previously described. The ileal loop on its distal edge is extracted through abdomen wall at the previously identified stoma point and fixed to abdomen fascia. The ureters are spatulated and a latero-lateral anastomosis according to Wallace 1 technique is performed."
15928119|NCT03434119|Drug|Insulin glargine/Lixisenatide|Insulin glargine (100 units per milliliter [U/mL]) and lixisenatide (33 micrograms per milliliter [mcg/mL]) self administered by a subcutaneous injection using a prefilled pen. Dose was individually titrated to achieve target fasting self-monitoring of plasma glucose (SMPG) of 80 to 100 milligrams per deciliter (mg/dL) (4.4 to 5.6 millimoles per liter [mmol/L]) while avoiding hypoglycemia.
15928120|NCT03434119|Drug|Insulin glargine (HOE901)|Insulin glargine 100 U/mL self-administered by a subcutaneous injection using a prefilled pen. Dose was individually titrated to achieve target fasting SMPG of 80 to 100 mg/dL (4.4 to 5.6 mmol/L) while avoiding hypoglycemia.
15928121|NCT03434119|Drug|Background therapy|Oral Anti diabetics Drugs (OADs) administered orally according to the locally approved label.
15928122|NCT03434106|Drug|liposic|Liposic eye gel contain the active ingredient carbomer, which is a type of medicine known as an eye lubricant. It is used for the treatmen
15928123|NCT03434106|Drug|Tears Naturale Forte|This medication is used to relieve dry, irritated eyes
15928124|NCT03434093|Device|Transcranial Magnetic Stimulation (TMS)|Description: This will comprise single and repeated paired-pulses delivered over motor and non-motor areas.
15928125|NCT03434093|Behavioral|Working Memory Task|This will consist in remembering an item presented 1 to 5 steps before the inquiry. This task will span the whole duration of the functional MRI acquisition.
15928126|NCT03434054|Drug|Losartan|blood pressure medication
15928127|NCT03434054|Other|Placebo|non-active sham intervention
15928128|NCT03434041|Drug|Esketamine 56 mg|Participants will self-administer 56 mg of esketamine as intranasal spray.
15928129|NCT03434041|Drug|Esketamine 84 mg|Participants will self-administer 84 mg of esketamine as intranasal spray.
15928130|NCT03434041|Drug|Placebo|Participants will self-administer matching placebo as intranasal spray.
15928131|NCT03434041|Drug|Duloxetine (Oral Antidepressant)|Duloxetine can be selected as the oral antidepressant medication based on investigator's discretion. The minimum therapeutic dose is 60 milligram per day (mg/day).
15928132|NCT03434041|Drug|Escitalopram (Oral Antidepressant)|Escitalopram can be selected as the oral antidepressant medication based on investigator's discretion. Escitalopram will be started at a dose of 10 mg/day and up-titrated to a maximum dose of 20 mg/day.
15928133|NCT03434041|Drug|Sertraline (Oral Antidepressant)|Sertraline can be selected as the oral antidepressant medication based on investigator's discretion. Sertraline will be started at a dose of 50 mg/day and up-titrated to a maximum dose of 200 mg/day.
15928134|NCT03434041|Drug|Venlafaxine Extended Release (XR) (Oral Antidepressant)|Venlafaxine XR can be selected as the oral antidepressant medication based on investigator's discretion. Venlafaxine XR will be started at a dose of 75 mg/day and up-titrated to a maximum dose of 225 mg/day.
15928135|NCT03434028|Drug|Early Vasopressors|"Norepinephrine will be used as preferred vasopressor and titrated to achieve mean arterial pressure (MAP) between 65 mmHg and 75 mmHg. Rescue fluids may be administered as 500ml boluses if predefined rescue criteria are met."
15928136|NCT03434028|Drug|Early Fluids|"Additional 2 liter intravenous fluid infusion upon enrollment (may forego second liter if MAP/SBP and heart rate are normalized and clinical assessment if patient is fluid replete after the first liter). Administer 500ml fluid boluses for fluid triggers until 5 liters administered or development of clinical signs of acute volume overload develop. Rescue vasopressors may be administered after 5 liters of fluid, for development of acute volume overload, or if other predefined rescue criteria are met. Any type of isotonic crystalloid (normal saline, ringers lactate, balanced solution such as plasmalyte) is permitted."
15928137|NCT03434002|Other|Training by Virtual Reality Simulation|Those Randomized 15 residents will be receive Local Anesthetic Systemic Toxicity simulation training by Virtual Reality simulation and after two weeks, they will be evaluated by investigators by using the same performance evaluation tool.
15928138|NCT03434002|Other|Training by Mannequin Based Simulation|Randomized other 15 residents will be receive Local Anesthetic Systemic Toxicity simulation training by mannequin based simulation and after two weeks, they will be evaluated by investigators by using the same performance evaluation tool.
15928139|NCT03433989|Diagnostic Test|telephone interview|questionnaire PDEQ et IES-R
15928140|NCT03433976|Drug|spinal anesthesia|spinal anesthesia for planned cesarean sections
15928141|NCT03433963|Dietary Supplement|L-Arg supplement|L-Arg supplement will be prepared as pills, administered 9g each day in 3 times for 2 weeks.
15928142|NCT03433963|Dietary Supplement|Placebo|Placebo will be prepared as pills (the same size, color and shape as of L-Arg), administered 3 times daily for 2 weeks.
15928143|NCT03433950|Other|No Intervention|Observational
15928144|NCT03433937|Device|Negative pressure wound therapy|Wound dressing
15928145|NCT03433937|Other|Micropore tape|Wound dressing
15928146|NCT03433911|Device|FemBloc|Treatment with FemBloc for women who desire permanent birth control (female sterilization)
15928147|NCT03433911|Procedure|Laparoscopic bilateral tubal sterilization|Laparoscopic bilateral tubal sterilization for women who desire permanent birth control (female sterilization)
15928148|NCT03433898|Drug|BI 754091|Solution for infusion
15928149|NCT03433898|Drug|BI 754111|Solution for infusion
15928150|NCT03433872|Other|We Grow Together: The Q-CCIIT Professional Development System|We Grow Together is designed to strengthen high quality caregiver interactions with infants and toddlers. The starting point for the We Grow Together study is assessment of a caregiver's interactions with infants and toddlers in the caregiver's ECE setting, using the Q-CCIIT observational measure. Data from the Q CCIIT observations highlight areas for growth in the caregiver's practices and will inform a PD goal-setting process, with the help of a PD Provider. An array of We Grow Together materials targeting practices assessed by the Q-CCIIT measure and informed by professional development and behavior change research are organized into modules, and delivered on an interactive website. Over the course of a program year, each caregiver in the study will work with a PD provider who is trained in guiding caregivers through the use of We Grow Together materials.
15928151|NCT03433859|Drug|OnabotulinumtoxinA|OnabotulinumtoxinA in intradermal Injections on residual lower limb : 100 Units - 1 dose
15928152|NCT03433859|Other|Topical Aluminium Chloride (cosmetic product)|Topical Aluminium Chloride (cosmetic product) : 1 quantity sufficient on the lower limb
15928153|NCT03433833|Drug|Digoxin|Digoxin oral route once daily for 24 weeks.
15928154|NCT03433820|Other|Observation of wound healing|Observation of wound healing after skin biopsy
15928155|NCT03433807|Drug|Idebenone|900 mg idebenone/day (2 tablets to be taken 3 times a day with meals)
15928156|NCT03433794|Behavioral|Alcohol 101 Plus (TM)|It is a combination of several intervention components, including alcohol education, personalized feedback, attitude-focused strategies, and skills training. It also included a virtual bar, where participants provide information such as sex, weight, and state so that the program can provide tailored information on blood alcohol content (BAC) as well as state regulations regarding legal limits. The program provides updated BACs based upon choices about what to consume and how quickly to consume it. The intervention is highly interactive, with text, photos, videos, and narratives for fictional students with decision points where the participant chooses what the fictional student should do. It is a non-linear environment, where participants choose which sections of the website to explore.
15928157|NCT03433794|Behavioral|Booster|Personalized feedback was emailed to participants. Content included sex-specific descriptive normative information (i.e., drinks per week typically consumed by males and females at the same institution), as well as reminders of harm reduction strategies (i.e., techniques the participant reported using in their last survey, versus techniques not used).
15928158|NCT03433794|Behavioral|Lilly for Better Health|This is an online education session directed at other health behaviors besides alcohol. The site provides practical tips on general well-being such as healthy eating, physical activity, and stress management, as well as provides information on managing health conditions such as diabetes, heart disease and depression. It was not expected to influence alcohol use.
15928159|NCT03433781|Drug|50 gm CIVI/24 hours x 5 days every 4 week|Each one ml solution will contain 500 mg ascorbic acid in the addition of disodium edetate 0.25mg, sodium hydroxide 110 mg in water with a pH in the range of 5.5 to 7.0 adjusted with sodium bicarbonate and sodium hydroxide. Vitamin C will be dispensed continuously by a computerized ambulatory drug deliver (CADD) pump, which will bereplaced every 24 hours.
15928160|NCT03433768|Genetic|Real time PCR|We take peripheral blood sample at day one, six and ten of ovarian stimulation and measure mRNA expression of androgen receptor.
15928161|NCT03433755|Drug|evolocumab|Evolocumab will be administered per pre-filled auto-injector pen (AI/Pen). Participants will receive evolocumab (AMG 145) every 2 weeks or monthly subcutaneously.
15928162|NCT03433755|Drug|placebo|Placebo will be administered per pre-filled auto-injector pen (AI/Pen). Participants will receive placebo every 2 weeks or monthly subcutaneously.
15928163|NCT03433742|Other|Blood levels drawn|The patients will have their bloods drawn at the Hospital for Special Surgery during their regular, standard of care visit. The laboratory at the Hospital for Special Surgery will then test their bloods to determine the metal ion levels.
15928164|NCT03433729|Other|Patient agenda form|On arrival at the clinic patients are given an agenda form to prompt them to think about what issues they wished to discuss with their doctor. The form contains a prompt list of items they can tick, free space to write their own items, and a prompt to consider what is the most important issue for them and what they would like to happen before they leave their clinic appointment.
15928165|NCT03433716|Other|Ultrasound-guided Percutaneous Neuromodulation|It's a new intervention of sport physiotherapy. It´s an invasive technique. It is necessary an ultrasound
15928166|NCT03433703|Drug|Lenvatinib|"Lenvatinib capsules will be administered orally, once daily in continuous 28-day cycles.
~Body weight (BW) ≥60 kilograms (kg) - Lenvatinib 12 mg (taken as three 4-mg capsules); BW <60 kg - Lenvatinib 8 mg (taken as two 4-mg capsules)"
15928167|NCT03433690|Behavioral|HIIT|High Intensity Interval Training for twelve weeks
15928168|NCT03433690|Behavioral|Moderate training|Moderate training for twelve weeks
15928169|NCT03433677|Drug|LY900014|Administered by CSII
15928170|NCT03433677|Drug|Insulin lispro|Administered by CSII
15928171|NCT03433664|Device|CO2 laser|Fractional CO2 laser treatment using the DeepFX setting hand piece (Ultrapulse, Lumenis), performed under general anaesthetic at 4-6 week intervals. All treatments consisted of a single pass of 300Hz, 5% density and 50mJ energy with minimal overlapping
15928172|NCT03433651|Drug|Creatine monohydrate|Subjects will take by mouth 5 grams a day of creatine monohydrate powder.
15928173|NCT03433651|Drug|Placebo|Subjects will take by mouth 5 grams a day of placebo powder.
15928174|NCT03433625|Behavioral|Behavioural experiments for intolerance of uncertainty (BE-IU)|CBT
15928175|NCT03433612|Other|Classic Intercristal Line Technique|"Researcher will use the classic technique to estimate the L4-L5 interspace. The classic technique begins by palpating both the right and left posterior iliac crests and following the imaginary line that intersects each (intercristal line) with the non-dominant hand to the spine where it is estimated to intersect the L4 spinous process or L4-L5 interspace. A marker pen will mark an X lateral to the estimation, opposite side from the estimation of the other technique."
15928245|NCT03433092|Other|serum carotenoids|In each study, the serum concentrations of carotenoids were detected by high performance liquid chromatography
15928176|NCT03433612|Other|Novel SAIL Technique|"Researcher will use the novel technique to estimate the L4-L5 interspace. The SAIL technique begins by palpating the sacrum and the researcher sliding the non-dominant hand up the dorsal surface of the sacrum to the first interspace (L5-S1) and then up one more interspace to estimate the L4-L5 interspace. A marker pen will mark an X lateral to the estimation, opposite side from the estimation of the other technique."
15928177|NCT03433599|Other|Repeated exposure to acute Intermittent Hypoxia (rAIH)|Participants will be fitted with a mask that will be placed over mouth and nose. Tubing will be attached to the front of the mask. The session will last approximately 30-45 minutes with 60-90 seconds of lower oxygen (tubing attached, 9-10% oxygen level), alternating with 60-90 sec of normal room air (no tubing attached).
15928178|NCT03433599|Other|Normal Room Air|Participants will be fitted with a mask that will be placed over mouth and nose. Tubing will be attached to the front of the mask. The session will last approximately 30-45 minutes with 60-90 seconds of normal room air (with tubing attached to the mask) and 60-90 sec of normal room air (without the tubing attached to the mask).
15928179|NCT03433599|Other|Upper-limb Training by Research Staff|Training sessions will last for approximately 30 minutes, with additional time for set up. During these sessions, participants will be asked to complete a variety of tasks related to general arm/hand movement, gross grasping, fine grasping, and hand cycle using an arm ergometer. The number of repetitions will be monitored and adjust the difficulty to ensure appropriate task difficulty.
15928180|NCT03433599|Other|Lower-limb Training by Research Staff|Training sessions will last for approximately 30 minutes, with additional time for set up. During these sessions, participants will be asked to complete a variety of tasks related to general leg/foot movement, over-ground walking, treadmill walking, stair climbing training, leg cycling, standing frame, and NuStep. The number of repetitions will be monitored and adjust the difficulty to ensure appropriate task difficulty.
15928181|NCT03433586|Drug|Aspirin 81 mg|81mg of aspirin to be taken daily for 10-14 days
15928182|NCT03433586|Drug|Placebo|Placebo pill (visually identical to aspirin pill) to be taken daily for 10-14 days
15928183|NCT03433573|Device|Abbott Sensor Based Glucose Monitoring System|Subjects will wear the Abbott Sensor Based Glucose Monitoring System and will be asked to perform 4 blood glucose tests per day (pre-meal and before bedtime). Subjects will be asked to scan the sensor when each blood glucose test is performed.
15928184|NCT03433547|Procedure|Buckle|Surgical procedures of macular buckling
15928185|NCT03433547|Procedure|Vitrectomy|Surgical procedures of small gauge vitrectomy
15928186|NCT03433547|Other|Limbal paracentesis|Drainage of aqueous fluid (0.1-0.2 ml) through limbal paracentesis
15928187|NCT03433547|Other|Gas injection|Inject gas ( C3F8 100%, 0.2ml-0.3ml) into vitreous cavity through pars plana.
15928188|NCT03433547|Other|Peeling internal limiting membrane|Peeling internal limiting membrane with forceps
15928189|NCT03433547|Other|Gas tamponade|Filling the vitreous cavity with gas (C3F8, 14%)
15928190|NCT03433534|Other|Pharmacokinetic of Nivolumab|Nivolumab residual concentration is measured 14 days after administration of nivolumab 3 mg/kg as an intravenous infusion just before the new administration.
15928191|NCT03433508|Biological|Liberal|2 PRBC /day to maintain the target of Hemoglobin 10 to 11 gm/dL. PRBC will be given intravenously at least for 28 days
15928192|NCT03433508|Other|Restrictive|To maintain the target Hemoglobin of 7 to 8 gm/dL.
15928193|NCT03433495|Other|Melodic Intonation Therapy|
15928194|NCT03433482|Biological|MenACWY liquid|At visit 1 (day 1), each subject will receive a single dose of the investigational MenACWY liquid vaccine (GSK3536820A) aged for approximately 24 months in Phase 1 of the study (subjects randomized to study arm ACWY_Liq24) or vaccine aged for 30 months in Phase 2 of the study (subjects randomized to study arm ACWY_Liq30), administered by intramuscular injection in the deltoid of the non-dominant arm.
15928195|NCT03433482|Biological|MenACWY|At visit 1 (day 1), each subject will receive a single dose of the MenACWY vaccine in the Phase1 of the study (subjects randomized to study arm ACWY_1) or in phase 2 of the study (subjects randomized to study arm ACWY_2), administered by intramuscular injection in the deltoid of the non-dominant arm.
15928196|NCT03433469|Drug|Osimertinib|Given PO (orally)
15928197|NCT03433469|Procedure|Therapeutic Conventional Surgery|Undergo surgery
15928198|NCT03433456|Behavioral|Home visitation + HABITS program|The HABITS program will target 5 key behaviors (physical activity, increasing fruit and vegetable consumption, decreasing sugary beverages, decreasing fried foods, and encouraging regular self-monitoring and self-weighing) aimed at reducing obesity risk in mothers or primary caregivers and children.
15928199|NCT03433456|Behavioral|Standard home visitation program|Treatment in the control arm includes the content and services typically provided by the home visitation partner, which is focused on promoting caregiver and child health by providing screenings and referrals, encouraging smoking cessation, promoting safe sleep practices, and strengthening children's school readiness and achievement, social/emotional and physical development.
15928200|NCT03433443|Behavioral|Case manager assisted rehabilitation|In addition to receiving usual physical rehabilitation the patients in the intervention group had a case manager assigned. A team of three case managers delivered the intervention: a medical doctor specialized in social medicine, an occupational therapist, and a social worker. The case managers were all experienced case managers for non-surgical low back pain patients. The allocation to the case manager was random, and all patients had a main case manager assigned. The case managers involved the other case managers if their special knowledge were needed. Barriers for the patient's rehabilitation were discussed with the multidisciplinary team also including a surgeon, a physiotherapist, and a nurse.
15928201|NCT03433443|Behavioral|Usual physical rehabilitation|The patients received usual physical rehabilitation at their community rehabilitation unit, and had no case manager assigned.
15928202|NCT03433430|Device|truSculpt|Subjects will receive up to three treatments and will be followed at 12 weeks post the first and final treatment.
15928203|NCT03433417|Device|Cutera truSculpt|one truSculpt treatment before scheduled Abdominoplasty on tissue to be removed during abdominoplasty
15928204|NCT03433404|Procedure|Soft Tissue Mobilization|The technique has been described previously in other descriptions. However, the main goal of this treatment is to address the LDSIL in the manner described previously in order to mobilize the soft tissue in the area.
15928246|NCT03433079|Diagnostic Test|Neutrophil gelatinase-associated lipocalin (NGAL)|Blood neutrophil gelatinase-associated lipocalin (NGAL) test was performed in all patients.
15928205|NCT03433404|Procedure|Soft Tissue Massage|For sMass, the subject will be positioned on her side opposite to the most painful side of the lumbosacral spine with the hips flexed to 45 degrees and knees flexed to 90 degrees (with a pillow positioned between them). The investigator will perform superficial (light stroke) massage to the painful side of the lumbosacral region for 5 minutes
15928206|NCT03433391|Device|Oxiplex|Oxiplex is a clear, viscoelastic gel that is applied to operative site during lumbar spine surgery in order to coat the nerve root with a protective barrier.
15928207|NCT03433391|Other|Surgery Only|Single level partial discectomy as per standard of care procedures.
15928208|NCT03433378|Drug|Tretinoin cream, 0.05%|Tretinoin cream, 0.05%
15928209|NCT03433378|Drug|RETIN-A® (tretinoin) cream, 0.05%|RETIN-A® (tretinoin) cream, 0.05%
15928210|NCT03433378|Drug|Vehicle of the test product|Vehicle of the test product
15928211|NCT03433365|Other|MRD analysis|To collect 2 samples for MRD analysis in patients treated with Lenalidomide
15928212|NCT03433352|Drug|Methimazole Pill|Patients who developed GD received methimazole treatment
15928213|NCT03433352|Drug|Propylthiouracil Pill|Patients who developed GD received propylthiouracil treatment
15928214|NCT03433339|Device|Active transcutaneous spinal direct current stimulation|Active anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
15928215|NCT03433339|Device|Sham transcutaneous spinal direct current stimulation|Sham anode electrodes placed at Thoracic 10 level, Cathode electrode placed on right shoulder.
15928216|NCT03433326|Drug|Elbasvir/Grazoprevir|Administration of MK-8742 (Elbasvir)/MK-5172 (Grazoprevir) for 12 weeks
15928217|NCT03433313|Drug|EG12014|EG12014 6mg/kg is ongoing to be administered after 8mg/kg loading dose.
15928218|NCT03433313|Drug|Herceptin|Herceptin 6mg/kg is ongoing to be administered after 8mg/kg loading dose.
15928219|NCT03433300|Device|Ottobock Kenevo/C-Leg|Microprocessor-controlled prosthetic knee
15928220|NCT03433300|Device|Ottobock 3R60/3R62|Nonmicroprocessor-controlled knee
15928221|NCT03433287|Diagnostic Test|18F-NaF-PET/MRI|PET/MRI scan after injection of 18F-labelled sodium fluoride
15928222|NCT03433274|Device|Tendyne Mitral Valve System|Mitral valve replacement
15928223|NCT03433274|Device|MitraClip System|Percutaneous mitral valve repair using the MitraClip system.
15928224|NCT03433261|Dietary Supplement|Ketogenic Diet|Eat a ketogenic diet (low carbohydrate, high fat diet) for 72 hrs prior to the experiment and consume a dietary ketone supplement 60 minutes before the experiment.
15928225|NCT03433248|Drug|EMPA/LINA 10/5 mg QD (n=22)|Once daily treatment with oral empagliflozin (Jardiance) 10 mg Once daily treatment with oral linagliptin (Tradjenta) 5 mg
15928226|NCT03433248|Drug|LINA/EMPA 5/10 mg QD (N=22)|Once daily treatment with oral linagliptin (Tradjenta) 5 mg Once daily treatment with oral empagliflozin (Jardiance) 10 mg
15928227|NCT03433248|Drug|Gliclazide 30 mg QD/BID (N=22)|Once daily or twice daily treatment with oral glicazide MR 30mg
15928228|NCT03433235|Drug|Edoxaban|"1-3-6-12 rule*
~Anticoagulation in patients with acute ischemic stroke and atrial fibrillation can be initiated from the following days after stroke event.
~After 1 day: transient ischemic attacks
~After 3 days: mild ischemic strokes (NIHSS <8)
~After 6 days: moderate ischemic strokes (NIHSS 8-16)
~After 12 days: severe ischemic strokes (NIHSS >16)
~- NIHSS: National Institute of Health Stroke Scales"
15928229|NCT03433222|Device|HF-LED-RL Phototherapy|"The starting dose of 480 J/cm2 will be administered to Group 1's HF-LED-RL phototherapy randomized subjects and the HF-LED-RL dose will be escalated in the subsequent group to 640 J/cm2. Common expected procedure side effects are mild and temporary, including warmth, redness (erythema) and swelling (edema). The maximally tolerated dose (MTD) is defined as the dose level below the dose producing unacceptable but reversible toxicity in 2 or more subjects and is considered the upper limit of subject tolerance.
~All subjects will receive total of nine LED-RL phototherapy, three times per week for three consecutive weeks."
15928230|NCT03433222|Device|Mock Therapy|"Mock therapy will be administered to mock therapy randomized subjects using the mock therapy unit. The mock therapy unit only generates warmth and does not emit LED-RL.
~All subjects will receive total of nine mock therapy procedures, three times per week for three consecutive weeks."
15928231|NCT03433209|Device|Ligasure device|Vessel-sealing device used for laparoscopic hysterectomy
15928232|NCT03433209|Device|Articulating Enseal|Vessel-sealing device used for laparoscopic hysterectomy
15928233|NCT03433196|Drug|HS-25 and Atorvastatin|HS-25 20mg (2 tablets), Atorvastatin 10mg, Placebo of Atorvastatin 1 tablet oral, once daily
15928234|NCT03433196|Drug|Atorvastatin|Atorvastatin 20mg (2 tablets), Placebo of HS-25 2 tablets, oral, once daily
15928235|NCT03433183|Drug|Selumetinib|Selumetinib (AZD6244) is an oral selective inhibitor of the mitogen-activated protein kinase (MEK) 1/2 currently in development for adult malignancies, pediatric low-grade gliomas and NF1 plexiform neurofibromas. MEK is a critical kinase in the mitogen activated protein (MAP) kinase signal transduction pathway for many growth factor receptors that provide growth signals to cancer cells.
15928236|NCT03433183|Drug|Sirolimus|Sirolimus is a macrocyclic lactone produced by Streptomyces hygroscopicus and inhibitor of mammalian Target of Rapamycin (mTOR) serine threonine kinase, which plays a critical role in regulating cellular energy sensing, growth and metabolism.
15928237|NCT03433170|Procedure|Quadrupled semitendinosus graft|Quadrupled ST graft as unique graft for the ACL reconstruction. Fixation with cortical button in femur and interference screw in tibia.
15928238|NCT03433170|Procedure|ST-Gracilis graft|Use of both semitendinosus and gracilis graft for the ACL reconstruction. Fixation with cortical button in femur and interference screw in tibia.
15928239|NCT03433157|Device|Hall technique|Metal Stainless stain crown placed with Hall technique
15928240|NCT03433157|Device|Traditional technique|Metal Stainless stain crown placed with Traditional technique
15928241|NCT03433144|Drug|Tranexamic Acid Injectable Solution|the drug will be given to patients intravenously at a dose of 10mg/kg pre-operatively after induction on general anesthesia
15928242|NCT03433144|Other|Placebo (normal saline 0.9%)|An equivalent amount of normal saline (0.9%) will be given to the patient pre-operatively after induction of general anesthesia. The amount of saline given will correspond to the same amount of fluid which would have been given had the patient been in the intervention group.
15928243|NCT03433131|Drug|Pitolisant|Tablets
15928244|NCT03433118|Device|Acupuncture|Acupuncture administered by specially-trained therapeutic radiographers
15928251|NCT03433066|Procedure|Advanced platelet-rich fibrin mixed with biphasic alloplast|mucoperiosteal flaps will be reflected to expose the defects , which will be debrided properly and finally filled with the freshly prepared Advanced platelet-rich fibrin mixed with the biphasic alloplast.
15928252|NCT03433066|Procedure|Biphasic alloplast mixed with saline|mucoperiosteal flap will be reflected to expose and clean the intrabony defect ,then it will be filled with biphasic alloplast mixed with saline.
15928253|NCT03433053|Behavioral|HIV Testing Message Intervention|The Health Belief Model will be utilized as the primary theoretical framework in guiding the development of a tailored HIV testing message for young African American women in this intervention. Two conditions will be developed and compared as outlined below. Condition 1 participants will be exposed to an HIV testing message inclusive of culturally tailored information that addresses both culturally specific barriers and facilitators of HIV testing (as identified in Study 1). The message will be brief (will take less than 3 minutes to present/read).
15928254|NCT03433053|Behavioral|Control|Condition 2 (generic message) participants will be exposed to a simple HIV educational message only, consisting of HIV statistics for women in the United States, information on how HIV is transmitted, where to get tested, and the benefits of HIV testing. The statistics on HIV and where to get tested will be taken directly from the CDC's website. The message will be brief (will take less than 3 minutes to present/read).
15928255|NCT03433040|Drug|17-Hydroxyprogesterone Capronate|17-Hydroxyprogesterone Capronate 250mg versus 500mg
15928256|NCT03433027|Drug|BB-401|BB-401 1.92ug/mL Intratumoral Injections, every week for up to 8 weeks
15928257|NCT03433014|Procedure|0.5% Levobupivacaine|The infiltration group will receive local infiltration with 0.5% Levobupivacaine. The trocar insertion sites are infiltrated before the skin incision is made. Using the Lap-Assist Transversus Abdominis Plane Block Technique, the total volume of infiltrated 0.5% Levobupivacaine is 20 ml, divided proportionally according to the length of the skin incision (2 ml for the 5-mm trocar and 3 ml for the 10-mm trocars, and 10 mL for specimen retrieval incision). The specimen retrieval incision will be performed in one of two techniques, depending on the surgeon's preference, a 4-6 cm length midline incision (extending from the Hasson trocar incision) or a 4-6 cm length Pfanensteil incision.
15928258|NCT03433014|Other|Control|No infiltration
15928259|NCT03433001|Drug|Ixazomib|Ixazomib capsules
15928260|NCT03433001|Drug|Lenalidomide|Lenalidomide capsules
15928261|NCT03433001|Drug|Dexamethasone|Dexamethasone tablets
15928262|NCT03432988|Behavioral|Nursing Solution-Focused|Two two-hour training modules were designed. In each module, participants watched videos that illustrated solution-focused communication on fluid adherence, and practiced the skills in role-plays. Solution-focused communication on IDWG. In the case of IDWG improvement, nurses were trained to congratulate the patient and then to explore in detail, from a stance of curiosity, how s/he had accomplished the weight reduction. Nurses were trained to invite patients to share specific behavioral details, to describe their own behavior from the perspective of significant family members and also to compliment patients on their accomplishments and to invite them to keep track of anything else they might find useful to control fluid intake over the next days.
15928263|NCT03432975|Drug|Povidone-Iodine 10%|The side of the mouth receiving the subgingival irrigations of povidone iodine 10% (test group)
15928264|NCT03432975|Drug|Saline Solution|The other side of the mouth will be irrigated with a sterile saline solution (control group)
15928265|NCT03432962|Other|no intervention - recoding of food recall only|recoding of food recall
15928266|NCT03432949|Drug|Dexamethasone plus Radium-223|Dexamethasone will be administered as 0.5 mg capsules by mouth per day during the duration of the Radium-223 treatment.
15928267|NCT03432936|Device|MRI guided procedure software evaluation|MRI guided ablation/biopsy using standard MR imaging along with Philips Interventional iSuite software tools.
15928268|NCT03432923|Drug|Benzocaine 8 mg|Benzocaine 8 mg, oval, white to slightly beige to yellow film coated tablet. One lozenge to be dissolved slowly in the mouth every 2 hours. Max 6 per day, max treatment 5 days.
15928269|NCT03432923|Drug|Placebo|Placebo, oval, white to slightly beige to yellow film coated tablet. One lozenge to be dissolved slowly in the mouth every 2 hours. Max 6 per day, max treatment 5 days.
15928270|NCT03432910|Other|CPAP Titration using a Bilevel S/T mode with minimal pressure support and background rate|The study performs within clinical routine with this exception that instead of the usually applied CPAP mode a modified BiLevel S/T mode is used. The modified BiLevel S/T mode meets the same requirements as the CPAP mode while providing the Forced Breath Technique to classify apneas as central or obstructive.
15928271|NCT03432897|Drug|Olaparib Pill|300 mg BID
15928272|NCT03432897|Procedure|Prostatectomy|22-42 days post Olaparib patients will undergo surgery
15928273|NCT03432884|Drug|BGB-3111|Subjects will receive BGB-3111
15928274|NCT03432884|Drug|Placebo|Subjects will receive Placebo
15928275|NCT03432884|Drug|Moxifloxacin|Subjects will receive Moxifloxicin
15928276|NCT03432871|Dietary Supplement|Nicotinamide Riboside|Nicotinamide Riboside is a member of the Vitamin B family which acts as a precursor to NAD+, an enzyme involved in energy production.
15928277|NCT03432858|Drug|Vancomycin|Vancomycin - 1-gram dosing
15928278|NCT03432858|Drug|Cefazolin|2-gram dosing for patients <120 kg 3-gram dosing for patients 120 kg or greater
15928279|NCT03432858|Drug|Saline Solution|Placebo
15928280|NCT03432845|Other|compare reversal agents|compare effect of two different approved reversal agents on postoperative and post-discharge nausea and vomiting
15928281|NCT03432832|Behavioral|EASE|Weekly behavioral sessions with therapist to work on emotional control through measures such as mindfulness.
15928282|NCT03432832|Behavioral|Supportive Therapy|Weekly behavioral sessions with a therapist to work on emotional control
15928283|NCT03432819|Behavioral|Siempre Seguiré|A culturally congruent CBT group intervention for HIV-positive LMSM, to include strategies for ART adherence and retention in HIV care.
15928284|NCT03432806|Other|blood draws|Patients will have 10 mL of peripheral venous blood drawn immediately prior to surgery, in the post anesthesia care unit (PACU), and at the first postoperative clinic visit for a total of 30 mL.
15928327|NCT03432624|Diagnostic Test|Serum MicroRNA-25 detection|The level of microRNA-25 in serum of patients will be detected using the MicroRNA (microRNA-25) Qualitative Detection Kit (Fluorescent PCR Method) and following the manufacture's instruction.*all arms are given the same intervention.
15928285|NCT03432806|Procedure|colectomy or hepatectomy|"Three small pieces of otherwise normal-appearing liver of 0.5-1 cm3 collected intraoperatively from patients in all four groups (including Group D). Because liver biopsy is less frequently performed during operations for benign colon lesions or Stage I-III colon cancers, this single aspect of the protocol can be made optional at the discretion of the surgical attending or the patient, however bloods and tissue from pathology will still be collected."
15928286|NCT03432806|Diagnostic Test|Fibroscan test|This may be done either at a preoperative clinic setting or immediately prior to surgery.
15928287|NCT03432793|Drug|TD-9855|oral tablet, QD
15928288|NCT03432793|Drug|Fluvoxamine|oral tablet, QD
15928289|NCT03432793|Drug|Itraconazole|oral tablet solution, QD
15928290|NCT03432793|Drug|Caffeine|oral solution, single dose
15928291|NCT03432780|Drug|Docetaxel|
15928292|NCT03432780|Biological|Hormone and radiation therapy|
15928293|NCT03432780|Radiation|Radiation therapy|
15928294|NCT03432767|Device|Non-invasive hemoglobin monitor|
15928295|NCT03432754|Behavioral|Mindfulness-Based Attention Training|The mindfulness-based attention training is closely modeled after the traditional mindfulness-based stress reduction (MBSR) protocol, it incorporates formal MBSR practices such as breath exercises, body scans and long sitting meditations. Specifically, MBAT is an abbreviated version of MBSR with a focus on the cognitive components.
15928296|NCT03432754|Behavioral|Lifestyle Education|"The control group, which will be used to compare the effects of mindfulness training on emotional and cognitive functioning and mind wandering in older adults, will comprise of scientific health and lifestyle information. Lectures will be focused on concepts presented in the book The Culprit and the Cure: Why lifestyle is the culprit behind America's poor health and how transforming that lifestyle can be the cure. Meetings will cover how to begin and maintain a more nutritious diet, classifying healthy choices across food groups, completing stretching/toning exercises, and reviewing homework."
15928297|NCT03432741|Drug|Belinostat|Given intralesionally
15928298|NCT03432741|Drug|Carfilzomib|Given intralesionally
15928299|NCT03432741|Drug|Copanlisib Hydrochloride|Given intralesionally
15928300|NCT03432741|Biological|Daratumumab|Given intralesionally
15928301|NCT03432741|Drug|Fludeoxyglucose F-18|Undergo FDG-PET
15928302|NCT03432741|Drug|Gemcitabine Hydrochloride|Given intralesionally
15928303|NCT03432741|Other|Laboratory Biomarker Analysis|Correlative studies
15928304|NCT03432741|Biological|Nivolumab|Given intralesionally
15928305|NCT03432741|Biological|Obinutuzumab|Given intralesionally
15928306|NCT03432741|Biological|Pembrolizumab|Given intralesionally
15928307|NCT03432741|Procedure|Positron Emission Tomography|Undergo FDG-PET
15928308|NCT03432741|Biological|Rituximab|Given intralesionally
15928309|NCT03432741|Drug|Romidepsin|Given intralesionally
15928310|NCT03432741|Other|Saline|Given intralesionally
15928311|NCT03432741|Biological|Trastuzumab|Given intralesionally
15928312|NCT03432728|Procedure|Dental rehabilitation under general anesthesia|Dental treatment of all teeth affected by dental caries in a single visit under general anesthesia
15928313|NCT03432715|Behavioral|Student Wellness Champions|"Student Wellness Champions participate in a training to, develop a rapport, and build trust with the wellness specialist. SWCs will meet once/week during lunch. The SWC's will receive a health education/ health literacy curriculum in order to be well-versed on the importance of being active and eating healthy foods and how to communicate health information to key stakeholders to enact policy change and to fellow students to enact behavior change. These students will work with the Wellness Specialist and Wellness Champion to implement wellness policies and practices.
~Target policies/practices will be presented as a menu of options. The mechanisms used to enact change are based in the tenets of health literacy anchored in nutrition and PA promotion. Components of the curriculum include raising awareness of school system's local wellness policies and improving student skills surrounding the five standards of health literacy, using examples/activities linked to the local wellness policy."
15928314|NCT03432715|Behavioral|Teacher Wellness Champions|"Schools will be asked to identify a Wellness Champion (WC), someone at the school who is passionate about creating a healthy school environment. All WC's will be asked to attend a Wellness Champions for Change (WCC) training, led by a Wellness Specialist (health educator part of our study team). The WC's will learn about the skills necessary to make health promoting changes to the School Environment.
~Following the WCC training, the Wellness Champion will receive technical assistance from the Wellness Specialist. The Wellness Specialist will work with the Wellness Champion and the school's Wellness Team to conduct a needs assessment, and develop and implement a school action plan. The Wellness Specialist will provide support and resources to the Wellness Champion and the school to help them work towards their goals. All Wellness Champions in a given school system will meet monthly, as a group, with their Wellness Specialist to discuss progress, pitfalls, and successes."
15928315|NCT03432702|Procedure|Horizontal ridge augmentation|Surgical procedures performed to provide the alveolar ridge with enough width and height to allow for the prosthetically driven implant placement.
15928316|NCT03432689|Device|Transcranial Magnetic Stimulation|Single-pulse transcranial magnetic stimulation and theta-burst stimulation
15928317|NCT03432689|Drug|Cycloserine|Cycloserine 100mg
15928318|NCT03432689|Drug|Placebo Oral Tablet|Placebo capsule matched to cycloserine capsule
15928319|NCT03432676|Drug|Epacadostat|Given PO
15928320|NCT03432676|Biological|Pembrolizumab|Given IV
15928321|NCT03432663|Drug|Intravenous amiodarone(1)|Intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg until 24 h was reached
15928322|NCT03432663|Drug|Intravenous amiodarone(2)|Intravenous amiodarone infusions at doses of 5 mg/Kg for over 30 min, followed by 20 mg/Kg every 24 h for up to 72 h or until sinus rhythm was reached
15928323|NCT03432650|Drug|Bupivacaine + dexamethasone|Anesthetic that will help treat pain and sensation after hip arthroscopy
15928324|NCT03432650|Device|Ultrasound|Ultrasound will help guide the anesthesiologist in performing the nerve block
15928325|NCT03432637|Procedure|spontaneous ventilation|thoracoscopic lobectomy under spontaneous ventilation
15928326|NCT03432637|Procedure|intubated anesthesia with single-lung mechanical ventilation|undergoing thoracoscopic lobectomy under intubated anesthesia with single-lung mechanical ventilation
15928328|NCT03432611|Other|Self-care information feature|The self-care feature offers information on self-care for menstrual pain. The following topics are shown: exercise, dietary supplementation, heating pad/hot water bottle, yoga, and information on when to consult a doctor and how primary dysmenorrhoea is often treated. Notifications from the app which can be deactivated remind women of surveys and activities.
15928329|NCT03432611|Other|Self-acupressure feature|The acupressure feature offers detailed written and multimedia descriptions of an acupressure used for menstrual pain. Three acupressure points are described, which should be massaged bilaterally twice a day up to five times a day on the 5 days before menstruation and during menstruation. Each point should be massaged for 2 minutes. A timer for the acupressure and notifications from the app which can be deactivated remind women of surveys and acupressure.
15928330|NCT03432598|Drug|Tislelizumab|Administered 200 mg intravenously (IV) as specified in the treatment arm
15928331|NCT03432598|Drug|Paclitaxel|Administered 175 mg/m² IV as specified in the treatment arm
15928332|NCT03432598|Drug|Gemcitabine|Administered 1250 mg/m² IV as specified in the treatment arm
15928333|NCT03432598|Drug|Etoposide|Administered 100 mg/m2 IV as specified in the treatment arm
15928334|NCT03432598|Drug|Pemetrexed|Administered 500 mg/m² IV as specified in the treatment arm
15928335|NCT03432598|Drug|Cisplatin|Administered 75 mg/m²/day IV as specified in the treatment arm
15928336|NCT03432598|Drug|Carboplatin|Administered AUC 5 as specified in the treatment arm
15928337|NCT03432585|Behavioral|Applicant Survey|This survey will ask a few brief demographic questions and will assess feedback from participants about preferences and barriers to conference attendance.
15928338|NCT03432572|Drug|Pyridium|a urine discoloration agent
15928339|NCT03432572|Drug|Riboflavin|a urine discoloration agent
15928340|NCT03432572|Drug|Thiamine|active placebo not known to cause urine discoloration
15928341|NCT03432559|Diagnostic Test|endoscopy|endoscopy of pharynx, upper esophagus, mid esophagus, cardia, gastric fundus, und gastric body
15928342|NCT03432546|Other|Non-interventional|Non-interventional
15928343|NCT03432533|Drug|romosozumab HCP administration with PFS|210 mg romosozumab SC QM by HCP administration with 2 PFS
15928344|NCT03432533|Device|romosozumab self-administration with AI/Pen|210 mg romosozumab SC QM by self-administration with 2 AI/Pens
15928345|NCT03432520|Genetic|SPK-8011|Observational long-term safety follow-up study of subjects previously treated with SPK-8011 in any Spark-sponsored SPK-8011 study
15928346|NCT03432507|Other|PCR|PCR for proinflammatory cytokines (IL-1b, IL-6, IL-8, IL-17, TNF-a, INF-g) and bacteria
15928347|NCT03432494|Device|Transcaval closure device (TCD)|This is an early feasibility study (EFS) evaluation of a purpose-built closure device for transcaval access. The device, the Transcaval closure device(TCD) will be evaluated for safety and performance to close transcaval access sites in patients ineligible for femoral artery access for TAVR
15928348|NCT03432481|Procedure|Unicompartmental Knee Arthroplasty Surgery|Unicompartmental Knee Arthroplasty Surgery using the Bodycad Unicompartmental Knee System (BUKS)
15928349|NCT03432481|Device|Bodycad Unicompartmental Knee System (BUKS)|Unicompartmental Knee Arthroplasty Surgery using the Bodycad Unicompartmental Knee System (BUKS)
15928350|NCT03432468|Drug|Valsartan 1|the high dose of valsartan
15928351|NCT03432468|Drug|Valsartan 80 mg|a single dose of valsartan
15928352|NCT03432442|Drug|Ivermectin|Ivermectin once every 24 hours for three administrations
15928353|NCT03432429|Other|REIMS iKnife|Use of REIMS iKnife in breast conserving surgery
15928354|NCT03432416|Drug|NES-E2 CVR|NES-E2 CVR
15928355|NCT03432403|Device|Ambu LMA|Will be randomized to either the new Gastro LMA or old Ambu LMA for EGD procedure and the intracuff pressure will be measured
15928356|NCT03432403|Device|Gastro LMA|Will be randomized to either the new Gastro LMA or old Ambu LMA for EGD procedure and the intracuff pressure will be measured
15928357|NCT03432390|Device|Continuous Positive Airway Pressure|A continuous positive airway pressure will be delivered to the patients during the induction of general anesthesia through the anesthesia work station
15928358|NCT03432390|Device|Open system ventilation|Facemask ventilation adapted to the anesthesia work station
15928359|NCT03432364|Genetic|ST-400 Investigational product|Single dose of ST-400 following chemotherapy conditioning with busulfan
15928360|NCT03432338|Other|inquiries|Inquires reported to clinician.
15928361|NCT03432325|Device|Neural Enabled Prosthesis|Surgically implanted neural enabled prosthesis
15928362|NCT03432312|Drug|Nicotine lozenge|Nicotine mint lozenge, 4 mg
15928363|NCT03432312|Drug|Nicotine lozenge|NiQuitin mint lozenge, 4 mg
15928364|NCT03432299|Procedure|RFA for PTMC|Radiofequency ablation for papillary thyroid microcarcinoma will be performed using the system including radiofrequency generator and internally cooled electrode.
15928367|NCT03432273|Drug|Nicotine lozenge|Nicotine mint lozenge, 2 mg
15928368|NCT03432273|Drug|Nicotine lozenge|NiQuitin mint lozenge, 2 mg
15928369|NCT03432260|Drug|DUR-928|Dose escalation including 3 doses: 30mg, 90 mg and 150 mg
15928370|NCT03432247|Behavioral|Interactive Music Therapy|Six 45-minute individual interactive music therapy (IMT) sessions delivered by a board-certified music therapist. Sessions start with music-guided breathing, imagery, or humming. The music therapist then engages the participant in singing of familiar songs and co-created vocal or instrumental music improvisations based on patient needs. Discussion about the meaning assigned to songs and emotions expressed through the improvisations follow. The IMT experiences are aimed at facilitating emotional expression, offering support through interactive music making, and strengthening inner resources of creativity. In addition, each week the participant learns music-based techniques for self-management of anxiety, stress, mood, and pain.
15928395|NCT03432000|Other|Performances of patients and controls on temporal task|To carry out this work, we will rely on an experimental paradigm (derived from Michotte's paradigm) which makes it possible to explore the links between temporal sequencing and perception of causality, validated in the normal subject. subjective consequences of these alterations will be explored using a phenomenological-inspired clinical scale (EAWE time-scale items)
15928396|NCT03431987|Drug|One day with a dose of placebo cannabis paired with alcohol|Vaporized placebo marijuana with little to no THC paired with drinking alcohol to BrAC of 0.05%
15928371|NCT03432247|Behavioral|Verbal support|Six 45-minute individual sessions delivered by a master's level clinician with training in counseling. The sessions are focused on patient-initiated conversations about their pain, life stressors and the impact on their daily life. The intervener provides nondirective, supportive care by offering supportive, validating statements and reflective listening. The intervener refrains from employing active suggestion, problem-solving or behavioral or cognitive therapy techniques. The verbal support sessions are aimed at providing an empathic, therapeutic environment to facilitate emotional expression and sharing of worries and fears.
15928372|NCT03432234|Other|Biomarkers|This is an observational study, there is no intervention
15928373|NCT03432221|Drug|Desvenlafaxine|Patients included in the study will receive antidepressant treatment with desvenlafaxine. The switch from SSRI to desvenlafaxine will coincide with the baseline visit (Visit 0). The dose of desvenlafaxine will be established based on clinical judgment. As the approach will be naturalistic, the inclusion in this study will not influence the clinical choice, hence changes in the pharmacological strategy will be permitted.
15928374|NCT03432208|Procedure|GI consult|
15928375|NCT03432195|Drug|Donepezil TDS|Donepezil Hydrochloride Transdermal Delivery System
15928376|NCT03432182|Diagnostic Test|electroencephalography|Sleep states definition by electroencephalograpy
15928377|NCT03432169|Other|Yoga (stretching plus mindfulness)|Stretching plus mindfulness
15928378|NCT03432169|Other|Stretching|Stretching alone
15928379|NCT03432156|Biological|Autologous Tcm cells immunotherapy|Autologous Tcm cells immunotherapy is to collect patient's own immune cells in peripheral blood and then given back to the patient after amplified in vitro.
15928380|NCT03432143|Other|Community Reviewers|Intervention manuscripts will be reviewed by both a trained community member and scientific reviewers. Community reviewers will follow each journal's instructions regarding electronic access to manuscripts, use of drop-down menus and free-text boxes to address specific aspects of the review, and completion within the time frame specified by the journal.The journal editorial team will use all reviews to make decisions about acceptance, revision, or rejection of manuscripts.
15928381|NCT03432130|Other|Structural training program|15-week experimental structural training protocol
15928382|NCT03432117|Other|Fixed respiratory rehabilitation|There are 6 step-exercise presented in the application and initial target of exercise will be set according to subject condition. After subject completes targeted exercise, next step will be started.
15928383|NCT03432117|Other|Responsive respiratory rehabilitation|The application provide responsive exercise program by changing type and numbers of exercise according to subject condition and exercise ability (This will be assessed with monitored O2 saturation, symptom of dyspnea and pulse rate during exercise)
15928384|NCT03432104|Dietary Supplement|Oxxynea®|Oxxynea® is a blend of polyphenol-rich extracts from olive, grape, pomegranate, green tea, grapefruit, orange and blueberry. Dosage is 1 x 450 mg-capsule.
15928385|NCT03432104|Dietary Supplement|Placebo|Placebo product is 100% maltodextrin. Dosage is 1 x 450 mg-capsule of identical appearance than the verum capsule.
15928386|NCT03432091|Drug|melatonin|Ramelteon RMT (RMT, Rozerem®), a novel MT1 and MT2 agonist, has been approved for treatment of insomnia, and provides a strong phase shift signal to the circadian timing system. Melatonin receptor agonists have recently become available for treatment of sleep and psychiatric disorders
15928387|NCT03432078|Other|Hypnotherapy|Non-pharmacological treatment
15928388|NCT03432065|Drug|Buspirone|Children with autism spectrum disorders will receive buspirone treatment for eight weeks. Buspirone will be titrated to the maximum daily dose during the first four weeks of the trial (dose titration phase). Week 4 onwards, subjects will be maintained on maximum achieved dose until the end of the trial. During the titration phase, total dose will be increased by 10mg at each visit and by 5mg on the 4th day after each visit.
15928389|NCT03432052|Procedure|centralization|Wrist centralization involves aligning the distal ulna with the middle finger metacarpal and passing a large Kirschner wire or a small Steinmann pin through the middle finger metacarpal, carpus, and ulna for temporary stability. This is followed by soft tissue balancing in order to counteract the volar and radial directed force vectors consisting of reefing the ulnocarpal wrist capsule and transferring the extensor carpi ulnaris muscle distally and flexor carpi ulnaris muscle dorsally on the wrist.
15928390|NCT03432039|Behavioral|Psychoeducation|This intervention has three phases occurring the same time as the Psychoeducation intervention. Phase I provides verbal and written information about the paediatric acute care unit services and policies. Phase II consists of: (a) verbal and written information about the general paediatric unit and its policies, and (b) a parent-child activity having ''control'' activities like reading a story not related to hospital stay. Phase III of the control program consists of a telephone call 2-3 days after discharge during which time mothers were informed that they should contact their primary healthcare providers if their children were having any problems or unusual symptoms. They also were asked to comment on their children's hospital stays during this telephone call.
15928391|NCT03432039|Behavioral|Behavioral|This is an educational-behavioural intervention that educates the parent about the children's likely emotional and behavioural problems that may result from ICU admission. Phase I will be delivered within 6 to 16 hours of admission to the hospital where caregivers are provided with information about the child's likely emotional reactions during admission in hospital. Phase II will be delivered within 2 to 16 hours of transfer to the general ward and will consist of: (a) verbal and written information to reinforce information provided in Phase I and (b) a parent-child skills building activities. Phase III of the COPE intervention program will occur 2 to 3 days after hospital discharge and will consist of a telephone call during which a 5 minute script will be read that reinforces young children's typical post-discharge emotions and behaviours and parenting behaviours which would continue to facilitate positive coping outcomes in their children.
15928392|NCT03432026|Device|High resolution computed tomography scan of the chest.|High resolution computed tomography scan of the chest & pulmonary function tests will be done for every patient to classify them.
15928393|NCT03432013|Behavioral|CUD-AMT|Participants will be trained to manage their negative thoughts and emotions while also receiving treatment for cannabis misuse
15928394|NCT03432013|Behavioral|SUD-CBT|Participants will receive traditional cognitive behavioral therapy for substance use disorder
15928397|NCT03431987|Drug|One day with a dose of active THC cannabis paired with alcohol|Vaporized marijuana with active THC paired with drinking alcohol to BrAC of 0.05%
15928398|NCT03431974|Drug|Aminopterin oral capsule|anti-folate treatment
15928399|NCT03431974|Drug|Placebo oral capsule|Microcrystalline filled capsule to mimic capsule containing aminopterin tablets
15928400|NCT03431961|Drug|Triamcinolone Acetonide|220 mcg administered twice daily for 14 days
15928401|NCT03431961|Drug|Placebo|twice daily for 14 days
15928402|NCT03431948|Drug|Nivolumab|Nivolumab 240 mg given by intravenous infusion every 2 weeks
15928403|NCT03431948|Drug|Cabiralizumab|Cabiralizumab 4 mg/kg given by intravenous infusion every 2 weeks
15928404|NCT03431948|Drug|Urelumab|Urelumab 8 mg given by intravenous infusion every 4 weeks
15928405|NCT03431948|Radiation|Stereotactic Body Radiation Therapy|Radiation to metastatic lesion(s) given at assigned dose levels based on lesion location and dose level being tested at time of enrollment. Doses range from 30 - 50 Gy.
15928406|NCT03431922|Device|endovascular denervation|multi-electrode catheter-based endovascular denervation
15928407|NCT03431909|Drug|Human urinary kallidinogenase (HUK)|Human urinary kallidinogenase can transform kininogen to bradykinin (kinin) and vasodilatory factors (kallidin)
15928408|NCT03431909|Drug|aspirin® , clopidogrel® , atorvastatin®|Patients in control group will receive foundation treatment, including aspirin® (100 mg/d), clopidogrel® (75 mg/d), and atorvastatin® (20 mg/d) for 14 days
15928409|NCT03431870|Other|Trans-esophageal echocardiography|Perform a trans-esophageal echocardiography before and after anesthesia.
15928411|NCT03431831|Behavioral|Intervention Control|diet recommendations of 1200 calorie limit for women daily and 1400 limit for men daily. Decreased foods that are high sugar, highly processed, low nutrient simple carbohydrates. Increased foods that are whole foods, lean proteins, complex carbohydrates and healthy fats. Switch from high calorie drinks to water for beverages.
15928412|NCT03431831|Behavioral|Counselling|Usual care as listed in comparator intervention plus motivational interviewing to identify areas of barriers and how to overcome them, to help patient set achievable food, physical activity and beverage goals for themselves weekly and monthly. To identify whether knowledge or confidence counseling is more important for each participant and follow up with them. To help them learn self-management techniques for overeating.
15928413|NCT03431831|Drug|Contrave|In addition to usual care as described in the comparator intervention, these participants will be prescribed Contrave and raised to the therapeutic dosage within one month. They will be monitored closely for side effects and meds adjusted accordingly.
15928414|NCT03431831|Drug|Contrave and Counseling|This group of participants will receive a combination of all the above interventions including diet/physical activity prescription, motivational interviewing and Contrave.
15928415|NCT03431818|Other|Nasal cannula flow rate|This is a crossover study where observations will be obtained at five nasal cannula flow rates: 0.5, 1, 2, 4 and 6 liters per minute.
15928416|NCT03431805|Drug|Tranexamic Acid Injectable Solution|After the routine and prophylactic administration of a uterotonic , the intervention will be the IV administration of a 10-ml blinded ampoule of the study drug (either TXA or placebo according to the randomisation sequence) to the woman within 3 minutes after birth, slowly (over 30-60 seconds), once the cord has been clamped.
15928417|NCT03431805|Drug|Sodium Chloride 0.9%|After a routine and prophylactic administration of a uterotonic , the intervention will be the IV administration of a 10-ml blinded ampoule of the study drug (either TXA or placebo according to the randomisation sequence) to the patient within 3 minutes afterbirth), slowly (over 30-60 seconds), once the cord has been clamped.
15928418|NCT03431792|Device|Long Tail Balloon|s. description of experimental Arm
15928419|NCT03431779|Procedure|Adipose derived stem cell transplantation via lipofilling|Liposuction of 60cc abdominal fat with its adipose derived stem cells which will be reinjected (10-20 cc) in the vestibular area after centrifugation for 3 minutes at 1000 rpm and decantation of oil and red blood cells.
15928420|NCT03431779|Procedure|Surgical excision|Excision of painful areas
15928421|NCT03431766|Device|placebo gel|On control group A once the dental implants are inserted on both mandible or maxilla of the patient placebo (group A) would be applied on the internal surface of the implants on all the surgical or prosthetic phases of the study.
15928422|NCT03431766|Device|0.20% chlorhexidine gel|On test group B once the dental implants are inserted on both mandible or maxilla of the patient a 0.20% chlorhexidine gel would be applied on the internal surface of the implants on all the surgical or prosthetic phases of the study.
15928423|NCT03431753|Diagnostic Test|PSA, STHLM3 and mpMRI for PC detection|"Men who request a prostate specific antigen test from their general practitioner will be offered study participation.
~Men with increased PC risk as judged from the STHLM3 test and/or an elevated PSA test will be offered an mpMRI examination."
15928424|NCT03431714|Drug|Artesunate amodiaquine|Drugs were administered under observation of the study nurse for three days
15928425|NCT03431701|Other|Chlorhexidine|Vaginal cleansing will be performed in conjunction with the abdominal preparation with foam sponge that contains chlorhexidine. A sponge soaked with chlorhexidine will be inserted into the vagina and rotated 360 degrees in the vaginal cavity for about 30 seconds
15928426|NCT03431701|Other|Iodine|Vaginal cleansing will be performed in conjunction with the abdominal preparation with foam sponge that contains iodine. A sponge soaked with iodine will be inserted into the vagina and rotated 360 degrees in the vaginal cavity for about 30 seconds
15928427|NCT03431701|Other|Antibiotics|All participants will receive a single body mass index (BMI) based antibiotic dose of cefazolin or clindamycin within 30 minutes prior to the incision.
15928428|NCT03431688|Drug|PAM|treatment with PPI, metonidazole, amoxicillin
15928429|NCT03431688|Drug|PBMT|treatment with PPI, metonidazole, bismuth, tetracyclin
15928430|NCT03431675|Drug|Ciprofloxacin|Single-dose oral ciprofloxacin
15928431|NCT03431662|Procedure|Ellipse IM HTO Nail|A CT scan will be performed at 3 and 6 months postoperatively to assess the healing of the osteotomy site. Endpoint is 6 months.
15928432|NCT03431662|Procedure|TomoFix|A CT scan will be performed at 3 and 6 months postoperatively to assess the healing of the osteotomy site. Endpoint is 6 months.
15928433|NCT03431649|Drug|Beraprost Sodium|1 mcg /kgbw daily, divided in three dosages orally for 12 weeks
15928434|NCT03431649|Drug|Sildenafil Citrate|0.4 mg/kgbw each time, 4 times in a day orally for 12 weeks
15928435|NCT03431636|Other|immersion|cold water immersion
15928436|NCT03431636|Other|ice pack|ice packs through the body
15928437|NCT03431636|Other|rest|seated rest
15928443|NCT03431597|Dietary Supplement|novel micronutrient|The supplements will be supplied to participants on a daily basis. The novel micronutrient supplement will be provided in powder form with instructions to dissolve one sachet in 250ml of clean water
15928444|NCT03431597|Dietary Supplement|existing micronutrient supplement, UNIMMAP|UNIMMAP will be provided in tablet form and given one daily
15928445|NCT03431584|Drug|infiltration of corticosteroids|infiltration of corticosteroids
15928446|NCT03431584|Drug|infiltration of corticosteroids and hyaluronic acid|infiltration of corticosteroids and hyaluronic acid
15928447|NCT03431571|Procedure|ReLEx SMILE|the VisuMax femtosecond laser is used to cut a thin layer of corneal tissue that is removed through a small cut in the cornea
15928448|NCT03431558|Combination Product|bLF (Bovine lactoferrin)|BLF administration in two different strengths (150 & 300mg) will be given on the third day of life with a single daily dose mixed with milk for 1 month.
15928449|NCT03431558|Drug|Glucon-D 99.4% (Placebo)|This group will be given 100mg Glucon-D (99.4% glucose) placebo which will be similar in shape, color to the bLF.
15928450|NCT03431545|Behavioral|PALS and|"Play and Learning Strategies (PALS) include web-based parent training courses with remote coaching and in-person meetings that support the adults' developing a set of core behaviors that comprise a responsive interactive style including responses contingent to children's needs and interests with rich language input.
~Parents will begin their 11 week (infant) or 14 week (toddler) parenting program in October and complete it by April. There will be monthly Parent Meetings related to the content they are learning online. Post-assessments will occur in late April and May. Each weekly online parent session will take approximately 30 minutes to complete with a 40 - 60 minute weekly remote coach call."
15928451|NCT03431545|Behavioral|BEECH|"Beginning Education: Early Childcare at Home (BEECH) includes web-based teacher training courses with remote coaching and in-person meetings that support the adults' developing a set of core behaviors that comprise a responsive interactive style including responses contingent to children's needs and interests with rich language input.
~Teachers will complete the 20 online sessions weekly, except for planned center closings due to holidays or agency-related events. The three in-person trainings will occur before Session 1 and after Sessions 8 and 14. Each weekly online teacher session will take approximately one-hour for a teacher to complete with a 30 minute weekly remote coach call. Each in-person teacher training will be 6-hours in duration."
15928452|NCT03431545|Behavioral|Control condition|Parents and teachers conduct business as usual in regards to care-giving in the school and at home.
15928453|NCT03431519|Procedure|VP|Percutaneous Injection of Strontium Containing Hydroxyapatite versus Polymethacrylate plus Short Segment Pedicle Screw Fixation
15928454|NCT03431506|Behavioral|Vestibular rehabilitation|Vestibular Rehabilitation Exercises
15928455|NCT03431493|Behavioral|Behavioral Activation - Rehabilitation|"Participants will first receive a home visit from a physical therapist (PT) who will evaluate home safety and establish/verify the participant's exercise prescription. Within 1 week, an occupational therapist (OT) will visit the home to: 1) explain the purpose of behavioral activation (BA); 2) help the participant identify long-term recovery goals regarding valued activities; and 3) then, using the principles of BA, identify short-term goals for the next week and an action plan. The OT will then call the participant weekly (weeks 2-5) to review the status of the prior week's goals and use BA to set new goals for the upcoming week. The PT and OT will repeat home visits at week 6 to assess the participant's progress, and the OT will conduct phone calls every 2 weeks for weeks 8-12."
15928456|NCT03431480|Biological|Autologous Human Placental Cord Blood Mononuclear Cells|Autologous human placental cord blood mononuclear cells are infused into the coronary artery during the Norwood heart operation
15928457|NCT03431467|Device|Impella-CP LV Vent|Patients randomised to the experimental arm will have an Impella-CP implanted in addition to VA-ECMO within a maximum of 10 hours of institution of VA-ECMO
15928458|NCT03431454|Procedure|trained to do the pencil push-ups procedure|15 minutes per day, five days a week
15928459|NCT03431454|Procedure|using a major amblyoscope twice weekly with additional home orthoptic therapy|60 minutes of orthoptic therapy using a major amblyoscope twice weekly with additional home orthoptic therapy was prescribed.
15928460|NCT03431454|Procedure|using three diopter over-minus lenses and a base out prism|For the augmented office-based vision orthoptic therapy (AOBVOT) group, orthoptic exercises using three diopter over-minus lenses and a base out prism, in addition to major amblyoscope and additional home reinforcement was prescribed in the same period of time.
15928461|NCT03431441|Device|JJVC Marketed Contact Lens|Female subjects that are habitual contact lens wearers between the ages of 18 to 39 will be dispensed 1 treatment of the JJVC Marketed Contact Lens during the 2-visit study.
15928462|NCT03431428|Procedure|transanal surgery|Transanal surgery could Preserve anus to reduce trauma and improve the quality of life
15928463|NCT03431428|Procedure|Miles surgery|Miles surgery cut off the anus, enlarge the trauma and reduce the quality of life.
15928464|NCT03431428|Drug|Preoperative chemoradiotherapy|After preoperative radiochemotherapy, two cycles of XELOX were given at the interval of waiting operation.
15928465|NCT03431415|Procedure|Anatomical Segmentectomy, Lobectomy or Bilobectomy|Lung Cancer Anatomical Resection
15928466|NCT03431415|Radiation|Stereotactic Body Radiation Therapy|SBRT treatment. 48Gy in 4 sessions for peripheral lesions and 50Gy in 5 sessions for central lesions.
15928467|NCT03431402|Drug|Hyperbaric oxygen|- HBOT group will receive 10 sessions of HBOT at 2.0 Atmosphere absolute (ATA) for one hour in a hyperbaric chamber pressured with compressed air, whereby patients will breath 100% oxygen to 2 ATA started within 3-5days after the onset of stoke plus conventional therapy as antiplatelets therapy, correction of hypovolaemia , hypoxia and adequate nutrition
15928468|NCT03431389|Device|Tracheostomy tube|Tracheostomy done to all patients by open surgical technique and was done in ICUs without need to transfer to theatre.
15928469|NCT03431350|Drug|Niraparib 200 mg|Participants will receive niraparib 200 mg orally.
15928470|NCT03431350|Drug|Cetrelimab 240 mg|Participants will receive cetrelimab 240 mg IV every 2 weeks.
15928471|NCT03431350|Drug|Cetrelimab 480 mg|Participants will receive cetrelimab 480 mg IV every 4 weeks.
15928472|NCT03431350|Drug|Abiraterone acetate 1000 mg|Participants will receive AA 1000 mg orally.
15928473|NCT03431350|Drug|Prednisone 5 mg|Participants will receive prednisone 5 mg orally.
15928593|NCT03430388|Biological|Yellow Fever vaccine (17D)|Vaccination against Yellow Fever, fractional dose (0,1mL) of 17D vaccine
15928474|NCT03431337|Drug|Amoxicillin 875 mg|Doubling the dose of amoxicillin by adding amoxicillin 875 to each dose of the standard treatment of amoxicillin/clavulanate 875/125
15928475|NCT03431337|Dietary Supplement|Placebo (lactase)|Placebo (in place of additional amoxicillin in experimental arm)
15928476|NCT03431324|Behavioral|Episodic Future Thinking about Mating Opportunities|"Participants who complete the mating-EFT intervention will be instructed to write about three positive mating-related events that would occur within the course of one year if you successfully quit smoking now. Participants will then be asked to close their eyes and imagine the events that they listed as specifically and vividly as possible (e.g., to imagine the setting and the sequence of the events, as well as the persons and objects that would be present. A period of one minute will be allotted for participants to mentally pre-experience each event.
~The general-EFT intervention will be structured similarly to, with the key exception of being instructed to write about and imagine three positive life events."
15928477|NCT03431324|Behavioral|Targeted Mating-EFT Intervention|"This intervention is identical to the Episodic Future Thinking about Mating Opportunities intervention with the exception that in Arm 2 the aim will be to determine whether the Mating-EFT intervention is especially effective when administered to individuals who are single or highly motivated to seek a mate."
15928478|NCT03431311|Biological|Adoptive Cell Therapy (ACT)|T cell receptor based therapy of metastatic colorectal cancer with mRNA-engineered T cells targeting mutant transforming growth factor beta receptor type II (TGFβII)
15928479|NCT03431298|Behavioral|Aerobic exercise & movement control|"The aerobic exercise content is no different between the experimental group and the active comparator group.
~The movement control is individual training which divided into fourths progressing sessions.
~First, lumbo-pelvic and hip dynamic direction control.
~Second, trunk muscle groups, hip muscle groups and thigh muscle groups extensibility control.
~Third, trunk muscle groups and hip muscle groups through range control.
~Fourth, functional movement control training"
15928480|NCT03431298|Behavioral|Aerobic exercise|"The aerobic exercise will organized in groups. Each group has 6-8 persons. The exercise form is fixed at each time.
~The description of exercise form is as below:
~10 min Warm up
~40 min Aerobic exercise (which focus on lower extremity muscle strengthening and increasing muscle endurance)
~10 min Cool down"
15928481|NCT03431285|Drug|Morphine Group|Patients will receive standard dose of morphine (0.1 mg/kg) in 100 ml normal saline infused over 30 min in addition to standard IV hydration.
15928482|NCT03431285|Drug|Ketamine Group|Patients will receive low dose ketamine 0.3 mg/kg in 100ml N.S. infused over 30 min in addition to standard IV hydration
15928483|NCT03431285|Other|standard IV hydration|IV hydration as per our institutional protocol (Lactated Ringer's or NaCl 0.9% solution will be infused at a rate of 2-3 ml/kg/h)
15928484|NCT03431272|Drug|Lifitegrast|Eye drop
15928485|NCT03431259|Other|Patient Gateway|Patients will be enrolled in the Patient Gateway app.
15928486|NCT03431246|Biological|Gardasil and Gardasil-9|All subjects will receive one dose of Gardasil-9. Blodd samples for serological testing will be collected just before and one month post Gardasil-9 administration.
15928487|NCT03431233|Dietary Supplement|Protein-enriched bar, commercial cereal bar, or water|Protein enriched bar, commercial cereal bar, or water will be provided 15 minutes before breakfast.
15928488|NCT03431220|Device|RENASYS® TOUCH Negative Pressure Wound Therapy (NPWT) Device|NPWT applied to Grade 1 or Grade 2 open abdomen wounds for temporary abdominal closure for up to 14 days, with a 21 day post study initiation follow-up assessment.
15928489|NCT03431207|Other|Standardized video recording for behaviors|"A standardized apparatus, scenario, and procedure was applied to record all the behavioral phenotypes with minimized background interference and stimulation.
~For each standardized procedure, the guardian sits in the chair, holding the infant facing the stage. Each infant is given a few minutes to adapt to the surroundings and to be calm before recording. No hints or simulations are permitted during the entire process. The recording process lasted for over 5 minutes to ensure that behavioral phenotypes could be completely recorded."
15928490|NCT03431194|Drug|midodrine|oral midodrine tablets 5 mg
15928491|NCT03431181|Behavioral|MAP target 60-65 mmHg|Treating teams will adjust vasopressors to a target MAP range of 60 to 65 mmHg, avoiding vasopressor-induced MAP above this range.
15928492|NCT03431181|Behavioral|Usual care|Patients in the control arm will receive usual care (as per local practices).
15928493|NCT03431168|Drug|Azithromycin/TMPS|2 tabs po daily x 3 days at enrollment and at each monthly follow up visit
15928494|NCT03431168|Drug|Placebo/TMPS|2 tabs po daily x 3 days at enrollment and at each monthly follow up visit
15928495|NCT03431155|Other|Nursing intervention|Nursing Intervention: Protocol and education booklet were developed according to literature and Theory. There were six modules (10 session) which aimed to personal education for every care givers. Every session took 20 minutes and total 200 minutes. First 5 modules finished within 3 days and aafter one week last module completed (to summarize process). Also individual counseling were made.
15928496|NCT03431142|Drug|Clopidogrel|Additional 9 months of clopidogrel monotherapy after 9-12 months of DAPT (aspirin+clopidogrel)
15928497|NCT03431142|Drug|Clopidogrel+aspirin|Additional 9 months of clopidogrel plus aspirin after 9-12 months of DAPT (aspirin+clopidogrel)
15928498|NCT03431129|Diagnostic Test|Hyperpolarized gas and proton lung MRI|Lung MRI for participants undergoing radiation therapy (RT)
15928499|NCT03431116|Radiation|ultrasound|to detect the placental site
15928500|NCT03431103|Behavioral|Exercise|12 week home exercise program
15928501|NCT03431090|Device|CliniMACS® TCRαβ/CD19 Combined Depletion System|The mobilized peripheral blood cell collection (apheresis product) will be processed using a Miltenyi CliniMACS device according to the manufacturing instructions. The processing will deplete the αβTCR+ cells and CD19+ cells from the apheresis product to formulate the graft.
15928502|NCT03431077|Drug|Angiotensin II|Angiotensin II is a peptide hormone naturally produced by the body that regulates blood pressure via vasoconstriction and sodium reabsorption. LJPC-501 (angiotensin II) is being developed for the treatment of hypotension in patients who do not respond to fluids and vasopressor therapy.
15928503|NCT03431064|Other|Lung Recruitment Maneuver|Lung Recruitment Maneuver by Anesthesiologist
15928504|NCT03431064|Other|Fluid Administration|Administration of IV Fluid by Anesthesiologist
15928505|NCT03431051|Other|Healthy Beverage Initiative|A Healthy Beverage Initiative will be instituted at two hospital campuses.
15928506|NCT03431025|Device|Wearable sensors and biofeedback|Participants in the Experimental Arm will wear sensors to monitor their upper limb movement and will receive feedback from these sensors to encourage usage of the impaired limb during activities of daily living.
15928507|NCT03431012|Other|Agency Assignment framing|Linguistic framing used in written health messages. Each version of the messages described the pandemic flu and the efficacy of the antivirals using linguistic expressions that assigned transmission to either humans (HA: 'You can contract the virus when you touch…') or the pandemic flu virus itself (VA: 'It can infect you when you touch…')
15928508|NCT03431012|Other|Attribute framing|Linguistic framing used in written health messages. Each message described the side effects of the antivirals in terms of chances of either experiencing (negative framing: 'Uncommon side effects (10% of people will be affected)') or not experiencing side effects (positive framing: 'Uncommon side effects (90% of people will not be affected)') after using them.
15928509|NCT03430999|Drug|Calmangafodipir|Single ascending doses of 2 μmol/kg, 5 μmol/kg, and 10 μmol/kg
15928510|NCT03430999|Drug|Placebo|Placebo
15928511|NCT03430986|Device|JUVÉDERM® VOLUMA® with Lidocaine|Treatment with JUVÉDERM® VOLUMA® with Lidocaine injectable gel with optional treatment 8 weeks later.
15928512|NCT03430986|Other|No-treatment control|No treatment during the control period.
15928513|NCT03430973|Behavioral|Videos|Videos depicting various aggressive driving and road rage behaviors.
15928514|NCT03430973|Behavioral|Bumper stickers|Bumper stickers hypothesized to increase or decrease aggressive driving.
15928515|NCT03430973|Behavioral|Alcohol-related cues|Case of beer or water on passenger seat.
15928516|NCT03430973|Behavioral|Music|Lyrics and tempo of music will be manipulated to increase or decrease aggressive driving.
15928517|NCT03430973|Behavioral|Roadside vegetation|The roadside will contain trash to increase aggressive driving, or vegetation to decrease aggressive driving. There is also a control group.
15928518|NCT03430973|Behavioral|Video game|Participants will play a racing or neutral video game before driving in the simulator.
15928519|NCT03430960|Other|Phone Call|Participants will be followed-up via phone call by Acute Pain Research Nurse
15928520|NCT03430960|Other|Mobile App Survey|Participants will be followed-up via mCare mobile app
15928521|NCT03430947|Drug|Vemurafenib|Vemurafenib (960 mg twice a day) will be taken on days 1 - 28 of each 28-day treatment cycle.
15928522|NCT03430947|Drug|Cobimetinib|Cobimetinib (60 mg once a day) will be taken on days 1 - 21 of each 28-day treatment cycle.
15928523|NCT03430934|Combination Product|NAVI mapping with Indocyanine green|Moh's tumor imaging with Indocyanine green
15928524|NCT03430921|Device|Enlighten™ Laser and a MLA Attachment|Subjects will receive up to six treatments with the Cutera enlighten laser with the Micro-Lens Array handpiece attachment, and may undergo a 2mm punch biopsy before, immediately after, and up to 72 hours after treatment. Subjects may receive a biopsy per Investigator discretion either at one of the follow-up visits (6 weeks or 12 weeks) or 3 months post initial treatment.
15928525|NCT03430908|Other|Blind Gastric Tube Placement|The provider will be blinded to the ultrasound imaging throughout the entire insertion. This blind insertion process is the standard of care currently practiced at MSKCC. After the provider verbalizes that they have completed the insertion the investigators will stop the ultrasound imaging and complete the data form. No information will be given to the provider about the location of the gastric tube as to not deviate from the standard of care. The only time that information will be provided to the practitioner inserting the tube will be if the tube is positioned in any of the following positions that are thought to be potentially injurious if unrecognized. These positions include intrapulmonary, cranial, nasal or oral pharyngeal placements and diverticular or hiatal hernia sac coiling and remain unrecognized by the practitioner. These are considered positions that have the potential for injury and therefore will be divulged to prevent ensuing injury.
15928526|NCT03430895|Drug|durvalumab and tremelimumab|Patients will receive durvalumab 1500 mg and tremelimumab 75 mg IV Q4W for up to 4 doses/cycles, then durvalumab 1500 mg Q4W starting 4 weeks after the last combination treatment for up to 9 doses.
15928527|NCT03430882|Drug|Carboplatin|Given IV
15928528|NCT03430882|Drug|Paclitaxel|Given IV
15928529|NCT03430882|Drug|Sapanisertib|Given PO
15928530|NCT03430869|Drug|F-18 AV-45|In the present project, the investigators will recruit 40 patients with lifetime major depressive disorder, and 20 non-depressed cognitively normal comparison subjects. Alzheimer's disease pathology (A) was determined by measuring Aβ deposition by F-18 AV-45 PET.
15928531|NCT03430869|Drug|F-18-THK-5351|In the present project, the investigators will recruit 40 patients with lifetime major depressive disorder, and 20 non-depressed cognitively normal comparison subjects. All subjects will further undergo F-18-THK-5351 image study to detect underlying tau pathology. By doing this, the investigators will elucidate the neurodegenerative pathophysiology behind the link between depressive disorder and the subsequent development of dementia.
15928532|NCT03430856|Drug|Insulin Tregopil|Drug: Insulin Tregopil (IN-105) Mode of Administration: To be administered orally 10 ± 2 minutes prior to each major meal (breakfast, lunch and dinner) starting at the Randomization visit.
15928533|NCT03430856|Drug|Insulin Aspart|Drug: Insulin Aspart Mode of Administration: To be administered within 5 minutes prior to each major meal (breakfast, lunch and dinner) starting at the Randomization visit
15928538|NCT03430830|Drug|Ravidasvir 50mg|50mg, Tablet
15928539|NCT03430830|Drug|Ravidasvir 200mg|200mg, Tablet
15928540|NCT03430817|Drug|Citicholine|Patients will receive 1 gram (2 vials of citicholine; each 500 mg) every 12 hours given slowly intravenous over 10 minutes for 7 days then oral form of the drug will be used. Participants who can swallow will receive 500-mg (5ml volume; 100mg/ml) oral drops (syrup) twice a day. Participants who cannot swallow will receive the same dose as oral drops syrup of citicoline through a nasogastric (NG) tube or percutaneous endoscopic gastrostomy (PEG) tube in a total dose of 1000 mg/day for the remainder of the 30 days study period.
15928644|NCT03430102|Diagnostic Test|Indicor|Calculation of LVEDP via analysis of PPG waveform with Valsalva
15928541|NCT03430817|Drug|Amantadine|Patients will receive 200 mg of amantadine sulphate in a 500 ml solution every 12 hours by slow intravenous infusion over a period of 4 hours for 7 days then oral form will be used. Participants who can swallow will receive two 100-mg tablets twice a day. Participants who cannot swallow will receive the tablets of amantadine through a NG tube or PEG tube as 400 mg via crushed tablets with a 25-mL saline or water flush for the remainder of the 30 days study period.
15928542|NCT03430804|Other|Bishop score calculation of modified Bishop score in numbers by digital vaginal examination|Measurement of cervical length by transvaginal ultrasound and digital examination of Bishop score in 320 parturients undergoing labour induction at term
15928543|NCT03430791|Drug|Nivolumab 240 mg IV|Nivolumab IV 240mg IV every 2 weeks for maximum of 24 months.
15928544|NCT03430791|Drug|Nivolumab 3 mg/kg|Nivolumab IV 3mg/kg every 2 weeks for maximum of 24 months.
15928545|NCT03430791|Drug|Ipilimumab 1 mg/kg|Ipilimumab IV 1 mg/kg every 6 weeks for maximum of 4 doses.
15928546|NCT03430791|Device|NovoTTF200A (Optune)|A device to be worn continuously for a goal of 75% of the time, ranging from 18 hours daily nonstop or 22 hours daily with 2-3 days off monthly.
15928547|NCT03430778|Other|High end-tidal CO2|maintaining of end-tidal CO2 with the range of 40-45 mmHg
15928548|NCT03430778|Other|Low CO2 group|maintaining of end-tidal CO2 with the range of 30-35 mmHg
15928549|NCT03430765|Behavioral|Acceptance and Commitment Therapy|Single 2-hour individual Acceptance and Commitment Therapy coping skills session.
15928550|NCT03430752|Other|questionnaires|Participants were asked to respond to the questionnaires including the Chinese version of the Paediatric Quality of Life Inventory 4.0 Generic Core Scale (PedsQL 4.0), the Chinese version of the Center for Epidemiological Studies Depression Scale for Children (CES-DC), the Chinese version of Rosenberg self-esteem scale, the Chinese version of the Herth Hope Index (HHI) and the Chinese version of Resilience Scale for Children (RS10).
15928551|NCT03430739|Other|No intervention|No intervention
15928552|NCT03430726|Other|Probiotic yogurt drink|Food product; yogurt drink containing a multi-strain probiotic.
15928553|NCT03430713|Procedure|Measure of tooth color|Evaluation of agreement about measure of tooth color between clinicians using two dental shade guides and two spectrophotometers in the determination of the color of maxilary central incisors and canines.
15928554|NCT03430700|Drug|Pembrolizumab|Intravenous infusion
15928555|NCT03430687|Other|Laboratory Biomarker Analysis|Correlative studies
15928556|NCT03430687|Biological|Talimogene Laherparepvec|Given intravesically
15928557|NCT03430674|Behavioral|Exercise|Exercise, questionnaires and blood draws.
15928558|NCT03430661|Drug|ACT-246475|Lyophilized ACT-246475A to be reconstituted with 1 mL of water for injection
15928559|NCT03430661|Drug|Clopidogrel|Tablet for oral administration (300 or 600 mg)
15928560|NCT03430661|Drug|Prasugrel|Tablet for oral administration (60 mg)
15928561|NCT03430661|Drug|Placebo|Matching ACT-246475 placebo will consist of sterile 0.9% w/v sodium chloride solution
15928562|NCT03430661|Drug|Ticagrelor|Tablet for oral administration (180 mg)
15928563|NCT03430635|Procedure|Hepatectomy|Surgery of the liver: removal of a given part of the liver affected by hepatocellular carcinoma
15928564|NCT03430622|Behavioral|LTP Plus|LTP Plus is comprised of two components; Learning through play (LTP) and Interpersonal Psychotherapy (IPT). The LTP Plus is a low-literacy; sustainable program intended to provide parents with information on the healthy growth and development of their young children. The LTP research-based activities enhance children's development while simultaneously promoting attachment security through building parents' ability to read and be sensitive to their children's cues and through active involvement in their children's development. Plus the Interpersonal Psychotherapy (IPT) intervention is comprised of a supportive element, an educational element, a parenting element and an interpersonal relationship element. Intervention goals include helping mothers feel supported, empowered and confident about their parenting abilities, which would directly influence reduction in depressive symptoms as well as resolution of interpersonal conflicts.
15928565|NCT03430622|Other|TAU|This group will be on their routine care and will not be given any intervention
15928566|NCT03430609|Procedure|Laparoscopic treatment for endometrioma Astus©|Laparoscopic surgery will be performed by the same surgeon, according to the routine of the service.In all of the groups, endometrioma will be removed by means of the traction and countertraction techniques. Adhesiolysis will be performed to separate the ovary from the adjacent structures as needed. In case of cyst rupture, the contents will be aspirated, and the site where the endometrioma contents fell will be exhaustively rinsed. In the hemostasis , the investigators will use coagulation with bipolar tweezers Astus Medical© in this group.
15928567|NCT03430609|Diagnostic Test|AMH Level|"The AMH levels will be quantitatively measured via ELISA, Enzyme-Linked Immunosorbent Assay (Diagnostic Systems Laboratories, Webster, TX), with a detection sensitivity of 0.006 ng/mL.
~The participants' sera will be obtained from blood samples after centrifugation for 10 minutes to separate the cell contents and debris. Each serum sample will be transferred to polypropylene tubes and stored at -70ºC. Venous blood samples will be collected before surgery (on the day ultrasound is performed for antral follicle count, approximately 1 month before surgery) and 1, 3 and 6 months after surgery."
15928568|NCT03430609|Diagnostic Test|Transvaginal ultrasound for antral follicle count|The participants will be subjected to transvaginal ultrasound for antral follicle count before surgery (1 month before surgery) and 1, 3 and 6 months after surgery. This test will be performed during the early proliferative stage (days 3 to 6 of the menstrual cycle); the size of the endometrioma and the ovary volume will be recorded, and functional cysts or suspected malignant cysts will be ruled out. For measurement of cysts, the average diameter of the three perpendicular ovary dimensions will be considered. For antral follicle count, the total number of follicles with diameters under 9 mm will be considered.
15928569|NCT03430609|Procedure|Laparoscopic treatment for endometrioma Vicryl®|Laparoscopic surgery will be performed by the same surgeon, according to the routine of the service.In all of the groups, endometrioma will be removed by means of the traction and countertraction techniques. Adhesiolysis will be performed to separate the ovary from the adjacent structures as needed. In case of cyst rupture, the contents will be aspirated, and the site where the endometrioma contents fell will be exhaustively rinsed. In the hemostasis , the investigators will perform suture with 2-0 Vicryl® in this group.
15928647|NCT03430089|Biological|Shz QIV 0.5 mL, single dose|Administered intramuscularly into the deltoid muscle.
15960987|NCT03181100|Drug|Cobimetinib|Given PO
15928570|NCT03430609|Procedure|Laparoscopic treatment for endometrioma Surgicel®|Laparoscopic surgery will be performed by the same surgeon, according to the routine of the service.In all of the groups, endometrioma will be removed by means of the traction and countertraction techniques. Adhesiolysis will be performed to separate the ovary from the adjacent structures as needed. In case of cyst rupture, the contents will be aspirated, and the site where the endometrioma contents fell will be exhaustively rinsed. In this group, for hemostasis , the investigators will use matrix Surgicel®
15928571|NCT03430596|Drug|Pramipexole|The dose of pramipexole range from 0.375mg/d to 0.75mg/d , The accurate dose of pramipexole can be adjusted by the patient's condition and tolerance .
15928572|NCT03430596|Drug|Trihexyphenidyl hydrochloride|he dose of Antan range from 2 mg/d to 4 mg/d , The accurate dose of pramipexole can be adjusted by the patient's condition and tolerance .
15928573|NCT03430583|Drug|MZ101|Drug
15928574|NCT03430570|Behavioral|Tablet TRAC Emotion Regulation Intervention|The intervention focuses on developmentally appropriate strategies for emotion regulation during difficult situations, particularly those related to risk, using 3 primary groups of strategies identified during qualitative work in Project TRAC (R34 MH078750): 1) getting away (physically or cognitively) from triggers for strong emotions, 2) releasing emotional energy in healthy ways (physically or verbally) or 3) changing cognitions and appraisals about emotional triggers. Using strategies effective in TRAC, teens will engage in games to practice and apply strategies to risk scenarios, as well as personalize content learned.
15928575|NCT03430557|Procedure|PRP|platelet rich plasma
15928576|NCT03430557|Procedure|periapical surgery without PRP|retrograde MTA filling will be done after apicectomy and flap will be closed without filling anything in the bony lesion.
15928577|NCT03430544|Drug|Cariprazine Oral Capsule [Vraylar]|Cariprazine Groups (1.5 or 3mg/d): Cariprazine (VRAYLAR) capsules will be administered orally, once per day. Subjects in the 1.5mg group will receive 1 VRAYLAR capsule containing 1.5 mg cariprazine each day that study drug is administered. Subjects in the 3 mg group will be gradually titrated up to full dose: they will receive 1 VRAYLAR capsule containing 1.5mg cariprazine on the first and second days that study drug is administered and will receive 1 VRAYLAR capsule containing 3mg cariprazine each day for the rest of the medication period. The study medication period begins during the inpatient/induction phase and ends on the last day of outpatient treatment week 8 (approx. 10 weeks total). All VRAYLAR capsules will be over-encapsulated by the University of Pennsylvania Investigational Drug Services (IDS).
15928578|NCT03430544|Drug|Placebo oral capsule|PLACEBO Group: Visually identical placebo capsules will be supplied by the University of Pennsylvania Investigational Drug Service, with a dosing regimen matching the cariprazine groups.
15928579|NCT03430531|Drug|Lidocaine|Lidocaine 2% viscous (0.5ml) will be squirted on two cotton swab sticks and one will be gently inserted into each nostril, along the floor of the nose. Slight rotatory motion of the stick will be used to insert it as far as it goes with the intention to reach the nasopharyngeal wall (posterior wall of the nose). At that position the swab sticks will be left undisturbed for 5 minutes. The swabs will be taken out and this will be repeated twice more, using fresh swabs and 0.5ml of 2% lidocaine. The block would take about 30 minutes.
15928580|NCT03430518|Drug|Durvalumab|1.12g given IV on day 1 every 21 day cycle
15928581|NCT03430518|Drug|Eribulin|1.1 mg/m2 IV on day 8 of every 21 day cycle in the first 3 patients, then increased to 1.4mg/m2 IV on day 1 and day 8 of every 21 day cycle. If significant toxicity occurs in patients given the 1.1mg/m2 IV dose, then subsequent patients with receive eribulin 0.7mg/m2 IV on day 1 and day 8 of every 21 day cycle.
15928582|NCT03430505|Device|Bilevel|Basal respiratory mechanics in spontaneous breathing will be analyzed by optoeletronic plethismography (OEP), followed by bronchial provocation with hypertonic saline solution 4.5%, another 45-second OEP uptake, IPAP 12 and EPAP 8 bilevel applied for 10 minutes, and a new uptake. All abstractions are preceded by a forced and slow spirometry maneuver. The entire procedure takes 1 hour.
15928583|NCT03430505|Drug|Albuterol|Basal respiratory mechanics in spontaneous breathing will be analyzed by optoeletronic plethismography (OEP), followed by bronchial provocation with hypertonic saline solution 4.5%, another 45-second OEP uptake, 400 micrograms inhaled Albuterol, and a new uptake. All abstractions are preceded by a forced and slow spirometry maneuver. The entire procedure takes 1 hour.
15928584|NCT03430479|Drug|Cohort A|Radiation + Nivolumab + hormone therapy
15928585|NCT03430466|Drug|Durvalmab&Tremelimumab&Fulvestrant|Durvalumab and Tremelimumab once in 4 weeks Durvalumab for 13 months Tremelimumab for initial 4 months Fulvestrant : At baseline, then week 2, week 4 and after that every 4 weeks
15928586|NCT03430453|Procedure|Measure of the minimal intensity of stimulation during ultrasound guided peripheral nerve blockade|A needle is placed at the target under ultrasound guidance, the nerve stimulator is turned on and the intensity increased until motor response is observed. The Minimal Intensity of Stimulation is recorded before injection of local anesthetic
15928587|NCT03430440|Device|Apply CIPKA mode|The newly developed computer-integrated patient-controlled analgesia (CIPCA) mode increases or decreases the basal infusion rate with the use of the patient's bolus button. Compared with the conventional mode in which only the basal infusion rate is set to be fixed, the CIPCA mode sets the basal infusion rate, the increase / decrease rate of basal rate, and the increment / decrement interval.
15928588|NCT03430440|Device|Conventional mode|PCA pumps typically set a fixed basal infusion rate to set the analgesic to enter at a constant rate every hour (conventional mode).
15928589|NCT03430414|Diagnostic Test|Transcriptome Analysis|Transcriptome Analysis of Formalin Fixed Paraffin Embedded biopsies
15928590|NCT03430401|Behavioral|Perceptual-based memory encoding|"It will run for 12 weeks with a 1-hour training session each week, supervised by a rehabilitation professional.
~In addition, two 30-minute home-based training sessions will be completed by participants. In the home training session, participants will practice specific daily tasks that are covered in the previous professional-led session through the use of the computer-based intervention."
15928591|NCT03430401|Behavioral|Semantic-based memory encoding|"It will run for 12 weeks with a 1-hour training session each week, supervised by a rehabilitation professional.
~In addition, two 30-minute home-based training sessions will be completed by participants. In the home training session, participants will practice specific daily tasks that are covered in the previous professional-led session through the use of the computer-based intervention."
15928592|NCT03430401|Behavioral|Cognitive stimulation|The frequency, duration and the number of sessions will be consistent with the experimental interventions.
15928594|NCT03430375|Device|Alternating air wheelchair cushion|The Ease alternating air cushion has longitudinal air bladders which alternately inflate and deflate at 3 minutes intervals in order to change the areas of pressure to the skin for areas in contact with the wheelchair cushion/seat (buttock and posterior thighs). The Ease Alternating Pressure wheelchair cushion is 510(k) exempt.
15928595|NCT03430375|Device|Static air cushion|The Roho static air cushion is composed of multiple air bladders that are inflated to proper levels according to the individual's weight. This cushion is commonly used for individuals post spinal cord injury and sometime for individuals post stroke. The Roho wheelchair cushion is 510(k) exempt.
15928596|NCT03430362|Drug|Hyoscine N Butylbromide|7. Group A will receive injection Hyoscine butyl bromide 40 mg single intravenous dose
15928597|NCT03430362|Drug|Normal Saline 0.9%|Group B, will receive 2 ml of normal saline single intravenous dose
15928598|NCT03430349|Biological|Novel OPV2 candidate 1|"Live-attenuated serotype-2 poliovirus derived from a modified Sabin type-2 infectious cDNA clone and propagated in Vero cells; candidate 1 (S2/cre5/S15domV/rec1/hifi3).
~Modifications included the following:
~Changes to the viral nucleotide sequence in part of the 5'-untranslated region to improve the genetic stability of this major attenuating determinant of Sabin type-2 to avoid reversion by single nucleotide changes.
~Two modifications in the polymerase 3D to further improve stability of the attenuation and reduce frequency of recombination events
~Relocation of a key replication element from the 2C coding region to the 5'-untranslated region, to inhibit recombination."
15928599|NCT03430349|Biological|Novel OPV2 candidate 2|"Live-attenuated serotype-2 poliovirus derived from a modified Sabin type-2 infectious cDNA clone and propagated in Vero cells; candidate 2 (S2/S15domV/CpG40).
~Modifications included the following:
~Changes to the viral nucleotide sequence in part of the 5'-untranslated region to improve the genetic stability of this major attenuating determinant of Sabin type-2 to avoid reversion by single nucleotide changes.
~silent non-coding modifications engineered within the capsid (VP1-4) designed to reduce replicative fitness and, potentially, to improve stability of the attenuated phenotype while also reducing transmission."
15928600|NCT03430336|Other|CDSS provides drug-therapy relevant information|External computerized decision support system (CDSS: RpDoc® eMMa Software, RpDoc® Solutions GmbH, Saarbruecken) provides drug-therapy relevant information about participating patients with polypharmacy on demand to the general practitioners (GPs) such as data about diagnoses and treatments. The information is based on claims data gathered from all health care professionals involved in the care of the patient (e.g. specialized physicians, other GPs, psychotherapists as well as data about hospital stays and prescription data from pharmacies).
15928601|NCT03430336|Other|Modification of medication|GPs can add and modify patient's data within the CDSS (e.g. remove drugs which are not taken by the patient anymore, add most recent laboratory findings about kidney function etc.) to enrich and update claims data based information.
15928602|NCT03430336|Other|Assessment of medication appropriateness|GPs systematically assess the appropriateness of the medication supported by the CDSS, which will alert in case of drug-drug, drug-disease, and drug-age interactions as well as other inappropriateness, such as prescriptions with regard to incorrect dosage or Dear Doctor letters.
15928603|NCT03430336|Other|Medication plan|GPs print out the updated medication plan including also recommendations for medication use and reasons for prescription in lay language (also available in foreign languages for patients with migration background) as well as recommendations on drugs to use / to avoid including over-the-counter drugs (OTC) (optional) and hand it out to the patient.
15928604|NCT03430336|Other|Guidance in medication process|GPs receive guidance via the CDSS (e.g. recommendations addressing certain types of medication errors and high risk prescribing, developed by the German Society for Internal Medicine in collaboration with other scientific medical societies).
15928605|NCT03430310|Other|Low Glycemic Diet|The investigators will use a Low Glycemic Load Diet (LG Diet), which emphasizes low-glycemic sources of carbohydrate, and includes mainly whole foods (vegetables, fruits, whole grains) with minimal highly processed grain products and added sugar. Protein foods will include meat, poultry, fish, eggs, and whey protein supplements if necessary (e.g., for vegetarians). Fat-containing foods will include olive, coconut, and nut oils; butter; tree nuts and nut butters; cheese; cream; coconut milk; avocados; and the fat found in meat. A number of full-fat dairy products will be included. Saturated fat from red meat will be limited to less than 10% of daily caloric intake. The participants will obtain the majority of their fat intake from mono-unsaturated fatty acids (e.g. olive oil), and medium-chain triglycerides (e.g., coconut oil and cream); from nuts and nut butters; and from fresh fish.
15928606|NCT03430310|Other|Control Diet|The Control diet will be compatible with both the American Diabetes Association and The United States Department of Agriculture guidelines. Participants will be given low-fat foods, whole-grain foods, fruits, and vegetables. The meal plans will minimize cholesterol, high-fat foods, high-cholesterol foods, processed starches, and added sugar, and will provide <2300 mg/day sodium. Saturated fat will be limited to less than 10% of total energy, and all dairy products will be fat-free (or low-fat). Although the Control diet will be a healthful diet, it will include a greater amount of carbohydrate foods from such sources as bread, potatoes, and pasta that will distinguish it qualitatively from the LG diet. In addition, it will have quantitatively more total energy from carbohydrate than the LG diet.
15928607|NCT03430297|Biological|JS001 240mg Q2W|"recombinant humanized anti-PD-1 monoclonal antibody injection (JS001) will be provided by the sponsor. Strength: 240mg/6ml/vial. 240mg, once every two weeks.
~Control drug: dacarbazine (1000mg/m2, d1, intravenously, once every three weeks). The dose will be given intravenously over 180 minutes (the infusion time can be prolonged according to the institutional criteria), starting from Week 1, once every 3 weeks, until progression of disease."
15928608|NCT03430297|Drug|Dacarbazine 1000mg/m2 Q3W|"The dose of DTIC will be calculated according to the following formula, where the 'X' represents the total mg dose of DTIC: X (mg) = [body surface area (BSA) x (1000mg/m2)].
~The body surface area (BSA) is defined by Dubois formula: BSA (m2) = 0.007184* (cm0.725) * (kg0.425)"
15928609|NCT03430284|Behavioral|Lifestyle therapy|The key components of lifestyle therapy include medical nutrition therapy, regular physical activity, sufficient amounts of sleep, behavioral support, and smoking cessation and avoidance of all tobacco products.
15928645|NCT03430089|Biological|Shz QIV 0.25 mL, 2 doses|Administered intramuscularly in the anterolateral aspect of the thigh in infants (aged 6 to 12 months) or into the deltoid muscle (participants aged more than 12 months), 28 days apart.
15928646|NCT03430089|Biological|Shz QIV 0.5 mL, 2 doses|Administered intramuscularly into the deltoid muscle, 28 days apart
15928610|NCT03430284|Drug|Pharmacotherapy|"Pharmacological therapy is individualized. 1.Glucose-lowering agents:
~Oral antihyperglycemic agents:Biguanides;Sulfonylureas;Thiazolidinediones;Glinides;a-Glucosidase inhibitors;DPP-4 inhibitors;Sodium-glucose cotransporter 2 inhibitors
~GLP-1 receptor agonist
~Insulin:Rapid-acting analogs;Short-acting analogs;Intermediate-acting analogs;Basal insulin analogs;Premixed insulin products
~2.Blood pressure-lowering agents
~(1)ACE inhibitor;(2)Angiotensin receptor blockers (ARBs);(3)Calcium channel blockers (CCB);(4)Diuretics;(5)β-blockers;(6)α1-blockers
~3.Lipid-modifying agents
~(1)Statins;(2)Fibrates;(3)Others: Nicotinic Acid, Ezetimibe,Probucol,Bile Acid Sequestrants,Policosanol,etc.
~4.Medications for weight management
~(1)Glucose-lowering agents associated with weight loss;(2)Orlistat;(3)Metabolic Surgery
~The above medications are individualized to maintain the risk factors (blood glucose, serum lipid profiles, blood pressure and weight) at appropriate levels."
15928611|NCT03430284|Other|Monitoring and management|Before follow-up, patients are divided into low, moderate or high risk for diabetic vascular complications. During follow-up, frequencies of interview and risk factor monitoring are formulated based on the risk stratification.
15928612|NCT03430284|Other|General treatment|General treatment is carried out based on the device from the general practitioners at present.
15928613|NCT03430271|Other|Physical Activity Intervention|Participants in this arm will complete exercise sessions 1 time per week for 24 weeks. An optional, second PA session will also be offered to PA participants. The exercise sessions will be multimodal and involve walking, lower extremity strengthening exercises, flexibility and balance training.
15928614|NCT03430271|Other|Healthy Aging Intervention|Participants will attend health education workshops on topics of relevance to older adults. Workshops will be offered weekly in a group setting, and participants will be required to attend biweekly.
15928615|NCT03430258|Device|high-flow nasal cannula|high flow of air with supplemental oxygen was delivered by an Optiflow cannula interface using an AIRVO 2 blower humidifier
15928616|NCT03430258|Device|Conventional oxygen therapy|Conventional oxygen therapy
15928617|NCT03430245|Device|VelaShape III|The VelaShape III device combines controlled infrared (IR) light and conducted bipolar radiofrequency (RF) energies with vacuum.
15928618|NCT03430245|Device|UltraShape Power|The UltraShape Power device uses focused ultrasound energy for lipolysis (breakdown of fat) via a non-thermal mechanism of action.
15928619|NCT03430232|Drug|Placebo|Short infusion of the solution for intravenous administration, Sodium Chloride 0.9%
15928620|NCT03430232|Drug|STR-324 Dose Level 1|Short infusion of a solution for intravenous administration
15928621|NCT03430232|Drug|STR-324 Dose Level 2|Short infusion of a solution for intravenous administration
15928622|NCT03430232|Drug|STR-324 Dose Level 3|Short infusion of a solution for intravenous administration
15928623|NCT03430232|Drug|STR-324 Dose Level 4|Short infusion of a solution for intravenous administration
15928624|NCT03430232|Drug|STR-324 Dose Level 5|Short infusion of a solution for intravenous administration
15928625|NCT03430232|Drug|STR-324 Dose Level 6|Short infusion of a solution for intravenous administration
15928626|NCT03430232|Drug|STR-324 Dose Level 7|Short infusion of a solution for intravenous administration
15928627|NCT03430232|Drug|STR-324 Dose Level 8|Short infusion of a solution for intravenous administration
15928628|NCT03430232|Drug|STR-324 Dose Level A|Long infusion of a solution for intravenous administration
15928629|NCT03430232|Drug|STR-324 Dose Level B|Long infusion of a solution for intravenous administration
15928630|NCT03430232|Drug|STR-324 Dose Level C|Long infusion of a solution for intravenous administration
15928631|NCT03430232|Drug|Placebo|Long infusion of the solution for intravenous administration, Sodium Chloride 0.9%
15928632|NCT03430219|Device|Subchondroplasty Procedure|AccuFill is an injectable, self-setting, macro-porous, osteoconductive, calcium phosphate bone graft substitute material that is intended for use to fill bony voids or gaps of the lower extremities (pelvis through foot) that are not intrinsic to the stability of the bony structure
15928633|NCT03430206|Device|High-flow nasal cannula|While applied, the cannula will deliver high-flow rate oxygen, air, or a mixture of variable oxygen concentration (21-100%) depending on the surgical conditions and requirements. The rate will be set at 2L/kg/min with a maximum of 70L/min. This will be only for the duration of the surgery or procedure.
15928634|NCT03430193|Other|FIRM|"FIRM program consisted of total 10 days session including PT, in two times twenty-minute sessions per day and 4 times OT during admission initiated before transfer to rehabilitation ward.
~PT (Weight bearing exercise, strengthening exercise, gait training, aerobic exercise and functional training) progressed gradually based on individual functional level and OT of activities of daily life (ADL) training (transfer, sit to stand, bed mobility, dressing, self-care retraining and using adaptive equipment) was provided."
15928635|NCT03430193|Other|Conventional rehabilitation|Conventional rehabilitation program consisted of total 10 days session of PT focused on simple standing and gait training, in one time twenty-minute sessions per day.
15928636|NCT03430180|Drug|Naloxone hydrochloride|Naloxone hydrochloride will be dosed at 4mg / dose (one spray of 0.1ml of the 40mg/ml formulation into one nostril) up to four times daily as needed in response to gambling urges with at least 2 hours between each dose (within 24 hours from 6am each day) for 12 weeks.
15928637|NCT03430180|Drug|Placebo|One spray of 0.1ml of the placebo formulation in one nostril up to four times daily as needed in response to gambling urges with at least 2 hours between each dose (within 24 hours from 6am each day) for 12 weeks.
15928638|NCT03430167|Other|home therapy|Patients will be given a set of instructions for completing home therapy for range of motion and strengthening
15928639|NCT03430167|Other|formal therapy|Patients will be sent to physical therapist for formal treatment to regain range of motion and strengthening exercises
15928640|NCT03430154|Other|No treatment given|No treatment given
15928641|NCT03430141|Other|Nutritarian Diet-style|Nutritarian Diet-style: Daily consumption of greens, beans/legumes, a variety of other vegetables, fresh or frozen fruits, nuts, seeds and whole grains. Participants are encouraged to minimize consumption of refined grains, vegetable oils, processed foods, and to limit animal products.
15928642|NCT03430128|Dietary Supplement|IMPACT immunotherapy|Powdered formula that is pre-packaged in individual packets which the patients will be instructed to mix with water before consumption.
15928643|NCT03430128|Dietary Supplement|ENSURE|Liquid milk formula available over the counter
15960988|NCT03181100|Drug|Nab-paclitaxel|Given IV
15928648|NCT03430076|Procedure|revascularization|open revascularization for below-knee popliteal in the absence of an suitable autologous vein with PTFE.
15928649|NCT03430076|Device|Propaten®|Propaten®
15928650|NCT03430076|Device|Crude PTFE|Crude PTFE
15928651|NCT03430063|Drug|SDREGN2810|Standard dose intravenous (IV) infusion
15928652|NCT03430063|Drug|SDREGN2810/ipi|Combination therapy dose IV
15928653|NCT03430063|Drug|HDREGN2810|High dose IV
15928654|NCT03430050|Drug|Progesterone|Progesterone capsule
15928655|NCT03430050|Drug|Placebo|Placebo capsule. Manufactured to mimic progesterone 200mg capsule.
15928656|NCT03430037|Dietary Supplement|Fisetin|Flavonoid Family
15928657|NCT03430037|Drug|Placebo oral capsule|Placebo
15928658|NCT03430024|Other|Association of Myosin VI with oestrogen receptor|"Gene expression analysis - RNA will be extracted from 100mg of tissue and then subjected to RT-qPCR to determine the relative expression levels of several genes, including MVI and ER Targets. We will use the same approach to determine which isoforms of MVI are expressed in the tissue.
~Protein content analysis - Total protein will be extracted from 100 mg of tissue and western-blot analysis will be used to determine the relative amounts of MVI. Moreover, we will use cell fractionation to determine relative amounts of nuclear versus cytoplasmic protein.
~Genomic analysis - Chromatin-immunoprecipitation (ChIP) experiments we be performed upon 100 mg of tissue sample. Here we will determine the localisation of MVI on the genome within the different tissues."
15928659|NCT03430011|Biological|JCARH125|Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCARH125. During JCARH125 production, participants may receive bridging chemotherapy for disease control. Following successful generation of JCARH125 product, participants will receive a course of lymphodepleting chemotherapy followed by one dose of JCARH125 administered intravenously (IV).
15928660|NCT03430011|Biological|JCARH125 + anakinra|Participants will undergo leukapheresis to isolate PBMCs for the production of JCARH125. During JCARH125 production, participants may receive bridging chemotherapy for disease control. Following successful generation of JCARH125 product, participants will receive a course of lymphodepleting chemotherapy followed by two doses of anakinra administered subcutaneously and one dose of JCARH125 administered IV. Subjects receive anakinra for 5 consecutive days following JCARH125 infusion.
15928661|NCT03429998|Drug|evolocumab|evolocumab 140 mg/biweekly
15928662|NCT03429998|Drug|evolocumab and LDL apheresis|evolocumab 140 mg/biweekly LDL-apheresis monthly
15928663|NCT03429998|Procedure|LDL apheresis|LDL apheresis biweekly
15928664|NCT03429985|Behavioral|FRRM Intervention|Fathers Raising Responsible Men (FRRM) is designed to facilitate important paternal parenting behaviors that influence adolescent decision-making. FRRM incorporates a novel, theoretically-based intervention highlighting the important and influential role that fathers have on the development and life trajectories of adolescent males.
15928665|NCT03429972|Device|Elasto-Gel™|Elasto-Gel™ hypothermia mitts and slippers contain glycerine, which has thermal properties, allowing use for cold therapies.
15928666|NCT03429972|Drug|Paclitaxel|80mg/m^2 of Paclitaxel is administered by infusion for 60 mins once a week, for a total of 12 cycles
15928667|NCT03429959|Device|SOCKNLEG|Donning and doffing success compared with the two study stockings, wearing the assigned study stocking for a day, Patient Quesationnaire on donning and doffing success and wearing comfort of each study stocking
15928668|NCT03429959|Device|SIGVARIS Cotton|SIGVARIS Cotton
15928669|NCT03429946|Drug|Spironolactone|Participants will receive spironolactone 12 hours and 3 hours before the initiation of the hyperinsulinemic clamp treatment.
15928670|NCT03429946|Drug|Placebo|Participants will receive placebo 12 hours and 3 hours before the initiation of the hyperinsulinemic clamp treatment.
15928671|NCT03429946|Other|Hypoglycemic Hyperinsulinemic Clamp|Participants undergo two 120-minute hypoglycemic (50 mg/dL) hyperinsulinemic clamps - an AM clamp from about 9 am to 11 am and a PM clamp from 1 pm to 3 pm on Day 2 of a 3-Day study visit. Modified Oxford Procedure is performed in duplicate at six time points - on Day 1, before the AM hyperinsulinemic clamp, during the AM hyperinsulinemic clamp, before the PM hyperinsulinemic clamp, during the PM hyperinsulinemic clamp, and on Day 3. The Modified Oxford procedure is performed to calculate baroreflex sensitivity.
15928672|NCT03429946|Other|Euglycemic Hyperinsulinemic Clamp|Participants undergo two 120-minute euglycemic (90 mg/dL) hyperinsulinemic clamps - an AM clamp from about 9 am to 11 am and a PM clamp from 1 pm to 3 pm on Day 2 of a 3-Day study visit.Modified Oxford Procedure is performed in duplicate at six time points - on Day 1, before the AM hyperinsulinemic clamp, during the AM hyperinsulinemic clamp, before the PM hyperinsulinemic clamp, during the PM hyperinsulinemic clamp, and on Day 3. The Modified Oxford procedure is performed to calculate baroreflex sensitivity.
15928673|NCT03429933|Drug|BMS-986278|Specified dose on specified days
15928674|NCT03429933|Other|Placebo|Specified dose on specified days
15928675|NCT03429920|Dietary Supplement|Q CAN PLUS|Active powder with fermented soy , 2 pouches per day, each pouch contains 12-15 gms of fermented soy
15928676|NCT03429920|Dietary Supplement|Placebo|Sprouted brown rice protein with flavor (provided by BESO Biological Research, Inc.)
15928677|NCT03429907|Behavioral|Mind-Body Exercises|Participants do daily mind-body exercises for 14 days before starting chemotherapy. The exercises are about 10 minutes per day.
15928678|NCT03429907|Behavioral|Questionnaires|Questionnaires completed at baseline, at third and at last cycle of chemotherapy, and 6 months after chemotherapy.
15928679|NCT03429894|Device|Percutaneous Coronary Intervention|Drug eluting stent implant
15928680|NCT03429881|Procedure|Stripping versus laser CO2|Patients were randomly selected to undergo either CO2 laser vaporization (L group) or laparoscopic stripping (S group) of OE.
15928681|NCT03429868|Device|integrated PET/MRI|"The enrolled subjects receive an integrated 18F-FDG PET/MRI scan in addition to the conventional 18F-FDG PET/CT on the same day during tumor staging.
~Whole body 18F-FDG PET/CT is performed one hour after injection of 10mCi of 18F-FDG. 18F-FDG PET/MRI is done after the PET/CT scan. And no additional 18F-FDG is given to the patients in the PET/MRI scan."
15928682|NCT03429855|Other|trunk training|Bobath based trunk training
15928683|NCT03429855|Other|physiotherapy|conventional physiotherapy
15928715|NCT03429569|Drug|Cross linking|Accelerated cross-linking procedure: (Total duration: 40 minutes)
15928716|NCT03429556|Biological|Botulinum Neurotoxin Serotype E|Single botulinum neurotoxin serotype E injection into RA muscles during abdominoplasty surgery.
15928684|NCT03429829|Device|Flairesse varnish|"Flairesse is applied to enamel and dentine as protective varnish to prevent caries formation and to promote remineralization of initial caries. It is also used in the treatment of hypersensitive teeth by sealing dentin tubules and hypersensitive areas at the neck of the tooth and exposed root dentine. Flairesse varnish contains xylitol and fluoride (22,600 ppm). Both components have been well established for oral health by reducing caries prevalence and incidences.
~During the application, children sat upright; their teeth were first cleaned and dried with cotton wool rolls. After mixing the fluoride varnish, it was applied as a thin layer to all surfaces of the lower and upper dentition, including proximal surfaces (using floss in case of tight contact points) as well as pits and fissures (using a small brush that was provided together with the varnish by the manufacturer). Children were advised not to drink or eat directly after the application, while this could not be controlled."
15928685|NCT03429816|Procedure|Biopsy|Patients with locally advanced, resectable gastric or esophagogastric junction adenocarcinoma will receive a biopsy of the primary tumor, followed by standard-of care neoadjuvant systemic treatment; after neoadjuvant therapy tumor biopsies will be taken from different sites of the resection specimen.
15928686|NCT03429803|Drug|DAY101|28 day cycle, oral, once per week
15928687|NCT03429790|Combination Product|intra-operative cell salvage|intra-operative cell salvage collects the patient's blood lost during an operation, processes it and returns it to their own circulation.
15928688|NCT03429790|Combination Product|allogeneic blood transfusion|transfuse allogeneic blood to patients if blood transfusion is needed.
15928689|NCT03429777|Device|HearMe Smartphone Application|The HearMe smartphone application is a digits-in-noise test that can be used to digitally quantify speech reception thresholds.
15928690|NCT03429764|Procedure|CISS|continuous independent sling sutures will be placed with minimum two intact contact points at the surgical site
15928691|NCT03429764|Procedure|VIMS|internal mattress suture will be placed with minimum two intact contact points at the surgical site
15928692|NCT03429751|Drug|30 ml/Kg/h crystalloid|Lung ultrasound 8 region assessment using curvilinear 2 to 5 megahertz prob after receiving 30 ml/Kg/h crystalloid in addition to losses for maximum 3 hours.
15928693|NCT03429751|Drug|10 ml/Kg/h crystalloid|Lung ultrasound 8 region assessment using curvilinear 2 to 5 megahertz prob after receiving 10 ml/Kg/h crystalloid in addition to losses for maximum 3 hours.
15928694|NCT03429738|Drug|Ibuprofen/Pseudoephedrine HCl 200/30 mg Film-Coated Tablets|Experimental drug
15928695|NCT03429738|Drug|RhinAdvil Rhume 200 mg/30 mg Film-Coated Tablets|Active Comparator
15928696|NCT03429725|Other|Online prime (statements writing)|Participants to write statements describing themselves or their similarities to their community.
15928697|NCT03429725|Other|Online prime (circling)|Participants to circle either pronouns denoting themselves or pronouns denoting others.
15928698|NCT03429725|Other|Online prime (Sumarian Warrior)|Participants read a passage which described the factors that led to his success in a war.
15928699|NCT03429725|Other|Online prime (all)|Participants wrote statements, circled pronouns, as well as read the Sumarian Warrior passage.
15928700|NCT03429712|Device|Dual-source multi-detector computed tomography (DSSE)|Dose split technique in a cohort of pediatric patients to determine, without increase in patient radiation dose, the optimal patient-specific and task-specific radiation dose levels for pediatric cardiothoracic and abdominal CT applications.
15928701|NCT03429699|Behavioral|Stage-based Lifestyle Modification Intervention for the Management of Childhood Obesity|The participants will receive treatment based on nutrition clinical practice guideline for the management of childhood obesity. Participants in IG will be received a nutrition clinical practice guideline for the management of childhood obesity that comprised several activities, including nutrition counselling, aerobic sessions, a hands-on activity (healthy food preparation) and 'Sharing is Caring'. The Nutrition Practice Guideline for the Management of Childhood Obesity that comprised recommendations for assessment of nutritional status, determination of energy requirement, dietary prescriptions and physical activity modifications will be used. Participants' SOC for dietary and physical activity behaviors will be determined before any information was given to ensure that the selected educational topic will be tailored to the participant's current SOC.
15928702|NCT03429699|Behavioral|Existing practice for the management of childhood obesity|The participants will receive treatment based on the existing practice for the management of childhood obesity. Only nutritional counseling will be received by CG and standard treatment based on current practices by most dietitians in Malaysia for weight management of obese children will be used.
15928703|NCT03429686|Other|DRT Intervention|The digital reminiscence therapy intervention will run 12 sessions twice per week, for six weeks, for up to an hour at a time (this will depend on the participant's ability and willingness to participate). The sessions of reminiscence therapy will be culturally appropriate and based on the key stages in the life which most people will have experienced. These sessions are individual, face-to-face sessions.
15928704|NCT03429673|Procedure|Surgeries|Lobectomy or segment/wedge dissection
15928705|NCT03429660|Other|Medical information|"The information collected are about :
~Introduction or non-introduction of treatment
~Cumulative dose of treatment
~Drug dispensation and withdrawal
~Hospitalization reason
~Safety information
~Demographic data (date of death)"
15928706|NCT03429647|Diagnostic Test|visible light spectroscopy|Sigmoid perfusion was assessed using visible light spectroscopy
15928707|NCT03429634|Procedure|Balloon-Stent Kissing technique|All patients underwent coronary angiogram that confirmed true bifurcation lesions, and received PCI treatment,Balloon-Stent Kissing Technique (BSKT)for the interventional treatment of coronary bifurcation lesion
15928708|NCT03429634|Procedure|Jailed Wire technique|All patients underwent coronary angiogram that confirmed true bifurcation lesions, and received PCI treatment, Jailed Wire technique(JWT) for the interventional treatment of coronary bifurcation lesion
15928709|NCT03429621|Drug|Simethicone 80 MG|Simethicone (Air-X®; 80 mg) 2 tablets chewing with water 50 ml at 2-8 hours before surgery
15928710|NCT03429595|Drug|ATx201|ATx201 GEL
15928711|NCT03429595|Other|ATx201 GEL Vehicle|Vehicle
15928712|NCT03429582|Device|Standard C02 Cryotherapy|Standard therapy using carbon dioxide for freezing of tissue
15928713|NCT03429582|Device|Single Tip Thermoablation|Thermoablator outfitted with a 19mm conical tip
15928714|NCT03429582|Device|Multiple Tip Thermoablation|Thermoablator outfitted with detachable probes
15960989|NCT03181100|Drug|Paclitaxel|Given IV
15928717|NCT03429556|Drug|Placebo|Placebo (sterile saline solution 0.9% Sodium Chloride Injection) injected into RA muscles during abdominoplasty surgery.
15928721|NCT03429517|Diagnostic Test|Lipogram|liporgram samples
15928722|NCT03429491|Dietary Supplement|Placebo|Protein-free, LC n-3 PUFA-free juice based supplement
15928723|NCT03429491|Dietary Supplement|Leucine-enriched protein|Leucine-enriched whey protein
15928724|NCT03429491|Dietary Supplement|LC n-3 PUFA|LC n-3 PUFA
15928725|NCT03429478|Other|Preoperative application of a bluetooth enabled Headphones.|A Bluetooth enabled Headphones device which is worn overhead and music can be played through it.
15928726|NCT03429465|Other|EVO Cognitive Remediation Game|EVO (formerly called Neuroracer) is a neuroscience-inspired plasticity trainings in the form of a video driving game that uses adaptive algorithms and dual-tasking paradigms to target the CCN. Work from our group (Project:EVO) recently showed that 4 weeks of EVO training is associated with increased neural recruitment in brain regions associated with CNN, superior improvement in cognitive control performance (i.e., working memory, sustained attention) when compared to an evidence-based psychotherapy (Problem-Solving Therapy), and improved depression outcomes similar to Problem-Solving Therapy among older adults (Areán, Hallgren, Jordan, Gazzaley, Atkins, Heagerty, & Anguera, 2016; Journal of Medical Internet Research).
15928727|NCT03429439|Other|intestinal microbiota transplant|Participants in experimental group take 6 times IMT with 2-week intervals.
15928728|NCT03429439|Drug|Antiviral Agents|All participants continue present antiviral therapy over 12 months.
15928729|NCT03429413|Behavioral|Protect Me 4 Application + External Quality Improvement Support|Participants will be asked to interact with the Protect Me 4 application, using an iPad tablet. During the implementation period (months 4-6), intervention clinics will receive the Protect Me 4 app and External Quality Improvement Support (practice facilitation and external and internal provider peer opinion leaders and provider incentives). Providers from intervention clinics will complete audit and feedback reports to assess HPV vaccination rates with the assistance of the practice facilitator. Providers at the intervention clinic will complete a pre-intervention survey to obtain background information (demographics, approximate HPV vaccination rates, comfort with the use of technology etc.)
15928730|NCT03429413|Behavioral|Protect Me 4 Application Alone|During the maintenance period (months 7-9), intervention clinics will receive Protect Me 4 without external support (practice facilitation and external provider peer opinion leaders). Providers from intervention clinics will complete audit and feedback reports to assess HPV vaccination rates without the assistance of the practice facilitator. Providers at the intervention clinic will complete a post-intervention survey to gain provider feedback regarding the feasibility of Protect Me 4 and changes in perceptions regarding the use of technology.
15928731|NCT03429400|Drug|Morphine Sulfate|Morphine every 4 hours as needed for up to a maximum of 5 days
15928732|NCT03429387|Diagnostic Test|FDG-PET/CT|FDG-PET performed with low dose CT
15928733|NCT03429387|Diagnostic Test|Conventional CT|HRCT and CT of sinuses +/- other regions as per clinician's discretion
15928734|NCT03429374|Device|Liquiband Fix8|LiquiBand® Fix 8™ (Advanced Medical Solutions - Plymouth, UK) is a hernia mesh fixation device providing strong and secure mesh fixation without causing any tissue damage or mechanical trauma. This device is designed to offer precise and controlled delivery of tissue glue (n-butyl-2-cyanoacrylate), resulting in a strong mesh fixation.
15928735|NCT03429374|Device|Absorbable tack|Absorbable tack
15928736|NCT03429361|Other|Health by Mindstrong|Health by Mindstrong is a smartphone application that collects data on a participant's smartphone usage patterns.
15928737|NCT03429348|Other|Sauna Rehabilitation|Firefighters selected for sauna rehabilitation will spend time in a sauna
15928738|NCT03429335|Behavioral|Teaching session|The cardiology nurse (RN) will have an hour long one-on-one teaching session prior to their pediatric cardiology clinic visit. The RN will go over the youth's cardiac history including the chronic heart disease diagnoses, names and dates of cardiac surgical procedures and cardiac catheterizations, and current cardiac medications and doses. She will also discuss transitioning from pediatric to adult care and healthy lifestyle choices.
15928739|NCT03429335|Behavioral|Just TRAC It!|Just TRAC It! (Transitioning Responsibly to Adult Care) is a mobile health intervention that encourages youth to use existing functions on their personal phones to track their health information. The use of Just TRAC It! allows youth to electronically document all medical information that would previously be printed on their MyHealth Passport, but may offer additional functionality in terms of learning to manage their health.
15928740|NCT03429335|Behavioral|MyHealth Passport|"MyHealth Passport is a customized, wallet-size card that includes the youth's important medical information. The RN will help the youth create a MyHealth Passport online, and print out the card for them.
~The same educational intervention will be completed by cardiology nurse using a MyHealth Passport to track their medical information instead of the electronic Just TRAC It!"
15928741|NCT03429322|Behavioral|Medical Care and Resource Facilitation|The intervention expands on an established web-based platform and uses other information and communication technology (ICT) devices, incorporating synchronous direct clinical care and asynchronous intervention. Participants will use their own devices and internet access for any and all interactions with Mayo Clinic providers. The specific ICT modes used and services provided to interact with participants will be determined by clinical need, individual preference, and technological capacity.
15928742|NCT03429322|Other|Usual Care|Participants will receive and provide usual and customary care in their communities.
15928743|NCT03429309|Drug|Propofol|Anesthesia was induced by intravenous infusion of propofol via the syringe pump at a rate of 30 mg/kg/h.
15928744|NCT03429296|Other|Autohypnosis learning|Patients are taught how to do auto-hypnosis by an hypnotherapist before all along their chemotherapy.
15928745|NCT03429283|Other|descriptive retrospective epidemiological study|descriptive retrospective epidemiological study
15928746|NCT03429270|Device|TDOC 5Fr|A Pivotal Study to Assess the Performance, Safety and Usability of a New 5 French Air-Charged Catheter for Performing Urodynamic Studies on Pediatric Subjects
15928798|NCT03428828|Behavioral|Amygdala Neurofeedback|Participants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories
15928747|NCT03429257|Other|Exposures of interest: Maternal EED and Aflatoxin Exposure|Maternal EED, measured via lactulose: mannitol (L:M) ratios and serum concentrations of antibodies to the bacterial components flagellin and lipopolysaccharide (LPS); Maternal aflatoxin exposure, measured via serum concentration of AFB1-lysine adduct
15928748|NCT03429244|Diagnostic Test|68Ga-PSMA-11 PET-MRI|Patients will undergo injection of 68Ga-PSMA-11 at the time of pre-treatment MRI scan and followed until biopsy and/or surgical resection.
15928749|NCT03429231|Dietary Supplement|Coenzima Q - QubiquinolCoenzyme Q - Qubiquinol|Patients in the active group will take one tablet a day orally
15928751|NCT03429205|Other|No external heating used during surgery|Deviation from external heating for all surgery standard
15928752|NCT03429205|Other|External heating blanket used during surgery|Standard external heating plan used in all surgery types
15928753|NCT03429192|Procedure|Surgery|Surgeries plus dissection of lymph nodes
15928754|NCT03429179|Drug|Butorphanol|intravenous loading dose of 15ug/kg butorphanol 5 mins before starting the surgery, then followed by infusion of 7.5ug/kg/h butorphanol and stopped infusion when the Ramsay sedation score (RSS) reached 4
15928755|NCT03429179|Other|Physiological saline|intravenous infusion of the same volume of 0.9% saline
15928756|NCT03429166|Behavioral|STAIR|A non-trauma-focused treatment
15928757|NCT03429166|Behavioral|PCT|A non-trauma-focused treatment
15928758|NCT03429140|Drug|Gel-One|an injection of Gel-One® (hyaluronan, 3 mL) 1-2 weeks after ACL surgery
15928759|NCT03429140|Other|Saline Placebo|a placebo injection (saline, 3 mL) 1-2 weeks after ACL surgery
15928760|NCT03429127|Other|Normal saline|Plasma osmolality, acid base status and electrolytes after application up to 2000 ml of normal saline during neurosurgical operation
15928761|NCT03429127|Other|Balanced fluid|Plasma osmolality, acid base status and electrolytes after application of up to 2000 ml balanced fluids during neurosurgical operation
15928762|NCT03429114|Other|Magnetic resonance imaging|We will conduct MRI and fMRI brain scans to compare brain function between groups.
15928763|NCT03429101|Drug|Poziotinib|Poziotinib is a tablet for oral administration.
15928764|NCT03429101|Drug|T-DM1|T-DM1 (ado-trastuzumab emtansine) is a HER2-targeted therapy for I.V. administration.
15928765|NCT03429088|Behavioral|Motivational interviewing telephone counseling|
15928766|NCT03429075|Drug|Psilocybin + Placebo|Multiple dosing days psilocybin vs 6 weeks of daily placebo
15928767|NCT03429075|Drug|Psilocybin + Escitalopram|Multiple dosing days psilocybin vs 6 weeks of daily escitalopram
15928768|NCT03429062|Other|Personal training exercises|Personal training: strengthening, stretching, endurance, balance Whole body vibration: strengthening, balance, stretching, endurance, balance
15928769|NCT03429049|Drug|CNTX-4975-05 (trans-capsaicin)|Receiving CNTX-4975-05 injection
15928770|NCT03429049|Drug|Placebo|Receiving Placebo injection
15928771|NCT03429010|Procedure|"New guideline anesthesia strategy team"|"New guideline anesthesia strategy team"
15928772|NCT03428997|Device|Lotion|Formulated Lotion F# 13451-131 was applied on an occlusive patch and placed on a test site on each subjects back three times a week for four weeks.
15928773|NCT03428997|Other|Negative Control|Control. An undosed occlusive patch was placed on a test site on each subjects back three times a week for four weeks.
15928774|NCT03428984|Drug|EXPAREL|EXAPREL 266 mg in 20 mL
15928775|NCT03428971|Procedure|cardioversion|Direct current (DC) cardioversion for sinus rhythm restoration
15928776|NCT03428958|Drug|NUC-3373 + leucovorin|NUC-3373 + leucovorin
15928777|NCT03428958|Drug|NUC-3373|NUC-3373
15928778|NCT03428958|Drug|NUFOX|NUC-3373 + oxaliplatin
15928779|NCT03428958|Drug|NUFOX + VEGF pathway inhibitor|NUC-3373 + oxaliplatin + bevacizumab
15928780|NCT03428958|Drug|NUFOX + EGFR inhibitor|NUC-3373 + oxaliplatin + cetuximab/panitumumab
15928781|NCT03428958|Drug|NUFIRI|NUC-3373 + irinotecan
15928782|NCT03428958|Drug|NUFIRI + VEGF pathway inhibitor|NUC-3373 + irinotecan + bevacizumab
15928783|NCT03428958|Drug|NUFIRI + EGFR inhibitor|NUC-3373 + irinotecan + cetuximab/panitumumab
15928784|NCT03428958|Drug|NUC-3373 + bevacizumab|NUC-3373 + bevacizumab
15928785|NCT03428945|Drug|Hydroxychloroquine|Hydroxychloroquine for oral administration, dosed by weight
15928786|NCT03428945|Drug|Placebo|Placebo tablet identical to active drug
15928787|NCT03428932|Device|Closed Loop (Medtronic 670G)|A loaner Medtronic 670G insulin pump, Enlite 3 sensor and GST3C Guardian transmitter will be utilized
15928788|NCT03428932|Other|Standard Care|Subjects will continue on their current treatment (insulin pump or injections), with follow up every 3 months.
15928789|NCT03428919|Procedure|ICSI|In ICSI group, insemination will be performed by using ICSI, 3 - 4 hours after oocyte retrieval. OCCs will be stripped by using hyaluronidase. Only matured oocytes will be inseminated.
15928790|NCT03428919|Procedure|IVF|In IVF group, insemination will be performed by conventional IVF. Two hours after retrieval, collected OCCs will be inseminated for another 2 hours, at a concentration of 100,000 motile sperm/ml. Inseminated OCCs will be cultured overnight in culture medium.
15928791|NCT03428906|Drug|Oxytocin|intranasally administrated
15928792|NCT03428906|Drug|Placebo|intranasally administrated
15928793|NCT03428893|Device|Mobile Application|Participants will receive usual care physical therapy guided by Clinical Practice Guidelines and based on individual symptoms and need over 7 in-person visits. Measures will be collected by the physical therapist related to leg strength, balance, fitness, and mobility as part of the usual care physical therapy evaluation and follow-up. The treating physical therapist will negotiate the physical therapy intervention based on patient preferences and goals and assessment findings. Using clinical practice guidelines, the intervention for the research participants is expected to address deficits in strength, mobility, balance, and cardiovascular endurance. Exercise prescription will be provided using the Wellpepper physical therapy exercise prescription mobile app.
15928794|NCT03428880|Drug|Morphine|spinal morphine is done before cesarean section
15928795|NCT03428880|Drug|Quadratus lumborum block|a US Block QLB is done after surgery
15928796|NCT03428854|Drug|LNG-IUS|Levnorgestrel containing IUD
15928797|NCT03428841|Procedure|Audiometry|
15960990|NCT03181100|Drug|Vemurafenib|Given PO
15928799|NCT03428828|Behavioral|Parietal Neurofeedback|Participants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories
15928800|NCT03428815|Device|Prosthesis suspension liner|Liners out of phase change material will be fitted
15928801|NCT03428802|Other|Laboratory Biomarker Analysis|Correlative studies
15928802|NCT03428802|Biological|Pembrolizumab|Given IV
15928803|NCT03428789|Procedure|Sensory nerve coaptation|A recipient sensory nerve of the abdomen was reattached to a donor nerve in the chest area. The sensory branch of usually the 11th intercostal nerve was used as recipient nerve for nerve coaptation and the anterior cutaneous branch of the third intercostal nerve was used as donor nerve. Direct, end-to-end nerve coaptation was performed with two stitches.
15928804|NCT03428776|Behavioral|Standard Compliance-linked incentives|Standard mobile-phone reminders and compliance-linked incentives Electronic immunization records on cloud-based software platform and use of biometric identification
15928805|NCT03428776|Behavioral|Intelligent Compliance-linked incentives|Intelligent mobile-phone reminders and compliance-linked incentives Electronic immunization records on cloud-based software platform and use of biometric identification
15928806|NCT03428776|Other|Record keeping|Electronic immunization records on cloud-based software platform and use of biometric identification
15928807|NCT03428763|Device|Homebased disease monitoring (eHealth)|"Participants allocated to the intervention group will be trained in self-monitoring (assessment of tender of swollen joints). Further they will be instructed in using a point-of-care CRP-measuring device to measure blood concentrations of C-reactive protein at their home, and to submit the self-monitoring results on a dedicated internet platform. These procedures represent a virtual visit.
~The participants are instructed to have virtual visit (self-monitoring) every month from allocation. The scheduled virtual visits include
~Joint score by the patient
~Patient global disease activity measured on a 0-100 mm visual analogue scale.
~CRP measurement on home-based device Based on the submitted data a DAS28-CRP is calculated and recorded in the eCRF."
15928808|NCT03428763|Other|Standard clinical disease monitoring|Those allocated to the control arm of the study will continue usual clinical care (i.e. they will not self-monitor or have access to the eHealth solution). No other medication changes will be mandated and participating investigators will be asked to manage all other care according usual clinical practice. Individuals in the control group will not be given the option to self-monitor.
15928809|NCT03428750|Biological|EN3835|Collagenase clostridium histolyticum
15928810|NCT03428750|Biological|Placebo|Placebo
15928811|NCT03428737|Procedure|Nocturnal controlled pressure control ventilation|use of an inspiratory pressure of 20 cm of H2O and an respiratory frequency chosen to stop all spontaneous breathing activity during the night
15928812|NCT03428737|Procedure|Pressure support ventilation|use of a pressure support level identical during the night to the pressure support level at the end of the day.
15928813|NCT03428724|Drug|Standard Preparation|standard PEG-based bowel preparation for colonoscopy (either split dose 4L polyethylene glycol or split 2L PEG + ascorbic acid)
15928814|NCT03428724|Drug|Individualized Preparation|individualized bowel preparation for colonoscopy (either split dose 4L PEG or split 2L PEG + ascorbic acid) based o patient characteristics (history of failed bowel preparation; use of laxative drugs, increased BMI, age>65, neurologic comorbidities)
15928815|NCT03428711|Drug|Mesoglycan Oral Tablet|"Experimental drug: mesoglycan, already used in the treatment of chronic venous ulcers, is a complex mucopolysaccharide, composed of a mixture of glycosaminoglycans (mainly heparan-sulphate, dermatan sulfate), inhibitors of thrombin and of Factor Xa and active in restore flow-mediated vasodilation.
~Used in oral formulation, hard capsules, 50 mg, twice-a-day, for 12 months. Reference therapy: placebo, organoleptically indistinguishable from the experimental drug, twice-a-day, for 12 months."
15928816|NCT03428711|Drug|Placebo Oral Tablet|Indistinguible placebo tablet
15928817|NCT03428698|Device|Aminogam|A lower third molar was extracted. All the surgical tools and materials as well as the surgical field were sterile. A full-thickness flap was raised and, if necessary, osteotomy and tooth sectioning were performed using a straight handpiece with dedicated burs under copious irrigation with sterile saline solution. The extraction was completed with curved and straight extractors, the socket was closely inspected and the dental follicle was removed. Depending on the group to which the patient was assigned, one of the following procedures was carried out.
15928818|NCT03428685|Drug|Dydrogesterone Oral Tablet|Oral dysdrogesteone 10mg tds will be prescribed from 12 - 36+6 weeks.
15928819|NCT03428685|Drug|Placebo Oral Tablet|Placebos will be prescribed from 12 - 36+6 weeks.
15928820|NCT03428672|Procedure|total hip arthroplasty|Bone samples from Hip fracture were collected from the femoral head which has been replaced
15928821|NCT03428659|Other|Data acquisition of functional abilities in sub-acute stroke|MRI data, motor evoked potentials, gait function and behavior data acquisition
15928822|NCT03428646|Drug|Dupilumab|Dupixent 1 dose at Baseline required for eligibility; otherwise, no therapeutic intervention required during the course of the study. In addition to (or substituting for) DUPIXENT®, participants may receive marketed drugs as deemed necessary by their physicians for the treatment of AD or comorbid conditions.
15928823|NCT03428633|Drug|Ropivacaine|Paravertebral block using ropivacaine preoperatively and postoperatively
15928824|NCT03428633|Drug|Morphine|Morphine intraoperatively and postoperatively
15928825|NCT03428620|Other|High Velocity Low Amplitude mobilization|Mobilizations will be performed one time at each joint, prior to completing the exercise protocol during the first three treatment sessions.
15928826|NCT03428620|Other|Exercise protocol|This exercise regimen is a modified version of the balance training program described by McKeon et al.
15928827|NCT03428607|Drug|AZD6738|AZD6738 160mg QD
15928828|NCT03428607|Drug|Olaparib|Olaparib 300mg BID
15928829|NCT03428594|Biological|CKD-11101|
15928830|NCT03428594|Biological|NESP|
15928884|NCT03428217|Drug|Cabozantinib|Oral receptor tyrosine kinase inhibitor
15928885|NCT03428217|Drug|Placebo|Placebo tablets
15928886|NCT03428204|Procedure|Balloon dilation during 180 seconds|Percutaneous angioplasty with balloon dilation during 180 seconds as a method for percutaneous treatment of femoropopliteal artery lesions
15929245|NCT03425292|Drug|Temozolomide|concomitant and 5-day adjuvant temozolomide
15928831|NCT03428581|Procedure|ALND with ARM +/- LVB|"Subjects will undergo removal of the lymph nodes in the underarm or axilla area. This is referred to as an axillary lymph node dissection (ALND). The procedure for identifying the drainage of the arm lymphatics during an axillary dissection has been coined axillary reverse mapping (ARM). Lympho-venous bypass (LVB) is a technique incorporated along with the ARM procedure that allows preservation of the lymphatics draining the arm while removing the standard lymph nodes and not compromising the extent of the axillary dissection."
15928832|NCT03428581|Procedure|ALND|Prospective and retrospective subjects undergoing an ALND.
15928833|NCT03428568|Other|Herbal Melanin|Herbal melanin extracted from Nigella sativa seeds
15928834|NCT03428568|Drug|Nexium|omeprazole
15928835|NCT03428568|Drug|Amoxil|Antibiotic
15928836|NCT03428568|Drug|Clarithromycin|Antibiotic
15928837|NCT03428555|Behavioral|Integrated Care Pathway|The intervention is a integrated care pathway based on the NICE Clinical Practice Guidelines and measurement-based care in the form of a flow chart. Each decision point on the pathway is guided by results of self-report measures for depression (the Mood and Feelings Questionnaire), functional impairment (Columbia Impairment Scales) and family functioning (the McMaster Family Assessment Device). The results of these scales and protocol recommendations are fed back to the patients, families and clinicians in order to make further treatment decisions
15928838|NCT03428555|Behavioral|Treatment As Usual|Treatment As Usual represents what clinicians would typically do when presented with an adolescent with depression. There is no algorithm provided to guide clinical decision-making and no systematic measurement-based care.
15928839|NCT03428542|Behavioral|Yin yoga|Yin yoga 2 times per week for 5 weeks. Daily breathing assignments.
15928840|NCT03428542|Behavioral|YOMI|"30 minutes of psychoeducation combined with mindfulness practice followed by 60 minutes of Yin yoga allowing the psychological theme to be further explored, aided by verbal instructions of the yoga teacher. 2 times per week for 5 weeks.
~Daily breathing assignments."
15928841|NCT03428529|Drug|Capecitabine Oral Product|Neoadjuvant Capecitabine concomitant to external beam radiotherapy
15928842|NCT03428529|Drug|5Fluorouracil|Neoadjuvant bolus 5-Fluorouracil concomitante to external beam radiotherapy
15928843|NCT03428516|Device|Fixed CPAP|CPAP is a device that applies continous fixed positive pressure to the airways in order to keep them opened during sleep
15928844|NCT03428516|Device|Auto-adjusting CPAP|Auto-adjusting CPAP is a device that applies auto-adjusting continous positive pressure to the airways in order to keep them opened during sleep
15928845|NCT03428503|Drug|Paracetamol|1000 mg of paracetamol (perfalgan 10mg/ml solutionBristol-Myers Squibb_UK) intravenous (IV) was given 100patients
15928846|NCT03428503|Drug|Dexketoprofen|Second group: dexketoprofen 50 MG (Arveles ampoule -Ufsa- Istanbul) intravenous (IV) was given 100 patients
15928847|NCT03428490|Behavioral|Fully integrated treatment|Clinicians will be delivering CBT for Social Anxiety Disorder directly into the context of the Matrix's evidence-based treatment for substance use disorders (i.e., The Matrix Model).
15928848|NCT03428490|Behavioral|Stand-alone Intensive Outpatient Program|Evidence-based treatment for substance use disorders (i.e., The Matrix Model).
15928849|NCT03428477|Drug|Icosapent Ethyl|Composition: soft amber to light yellow, oblong gelatin capsules. One capsule contains 1g pure EPA-EE Dose: 4 capsules per day
15928850|NCT03428477|Other|Placebo|"Composition: soft, amber to light yellow, oblong gelatin capsules containing light mineral oil:
~Dose: 4 capsules per day"
15928851|NCT03428464|Drug|Sodium Bicarbonate|Participants will take ½ the daily dose of sodium bicarbonate in the morning and the other ½ in the evening.
15928852|NCT03428464|Other|Placebo|Participants will take ½ the daily dose of a placebo in the morning and the other ½ in the evening.
15928853|NCT03428451|Drug|NaCl 3% HS|Hypertonic saline 3% is a type of crystalloid solution with osmolarity higher than that of plasma.
15928854|NCT03428451|Drug|NaCl 3% HS|Hypertonic saline 3% is a type of crystalloid solutions with osmolarity higher than that of plasma.
15928855|NCT03428451|Drug|NaCl 0.9% NS|Normal saline 0.9% is a type of crystalloid solution with osmolarity similar to that of plasma.
15928856|NCT03428438|Other|Rehabilitation at home via SMS|Cardiac rehabilitation
15928857|NCT03428425|Drug|paclitaxel apatinib S-1|"HIPEC: 43℃, 60min. the drug is paclitaxel : 70mg/m2 d1 d3 d5, The interval is not less than 24h , A total of three times.
~apatinib：500mg qd po, 28 days is a cycle.preoperative 2 cycles, 2 cycles after surgery.
~S-1： According to the body surface area, BSA <1.25m2，40mg bid; 1.25m2≤BSA≤1.5m2，50mg bid; BSA >1.5m2, 60mg bid. Take the medicine twice daily for 2 weeks, then suspend for 1 week. preoperative 3 cycles, 3 cycles after surgery"
15928858|NCT03428412|Drug|TCM and conventional drug|"All patients were treated with medicine based on 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines for AECOPD.
~The Experimental group will receive TCM according to the TCM syndrome. Sanhanhuayin granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of external cold and internal fluid in 14 treatment days.
~Qingrehuatan granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of phlegm-heat congesting lung in 14 treatment days.
~Zaoshihuatan granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of phlegm-damp amassing in lung in 14 treatment days."
15928859|NCT03428412|Drug|TCM placebo and conventional drug|"All patients were treated with medicine based on 2017 Global Initiative for Chronic Obstructive Lung Disease (GOLD) and Chinese Treatment Guidelines for AECOPD.
~The control group will receive TCM placebo according to the TCM syndrome. Placebo Sanhanhuayin granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of external cold and internal fluid in 14 treatment days.
~Placebo Qingrehuatan granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of phlegm-heat congesting lung in 14 treatment days.
~Placebo Zaoshihuatan granule (Jiangyin Tian Jiang Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for syndrome of phlegm-damp amassing in lung in 14 treatment days."
15928860|NCT03428399|Other|Psychosocial variables|The investigators will assess mental health history and self-reported psychosocial variables as hypothesized risk and protective factors for body image and depression severity in breast reconstruction patients, before and after their mastectomy and breast reconstruction surgery. Mastectomy and breast reconstruction will be received in the context of routine medical care. Thus, this is not a psychological intervention, but rather observational measures assessed pre- and post routine care for breast reconstruction patients.
15928861|NCT03428386|Procedure|Gastric plication ileal bypass|laparoscopic plication of the greater curvature of the stomach then the duodeno-jejunal junction is identified and 300 cm is measured downwards. The selected loop will be ascended without division of the greater omentum, and a stapled isoperistaltic side-to-side to the anterior wall of the antrum of the stomach just 3 cm away from the pylorus with a linear stapler charged with a green cartridge, the diameter of ileal antrum anastomosis is not exceeding 3 cm in diameter. The staple defect is closed with a two-layer running 3/0 polyglactin suture
15928862|NCT03428373|Drug|Rivaroxaban|Rivaroxaban 10mg daily
15928863|NCT03428373|Drug|ASA|ASA 81mg
15928864|NCT03428360|Drug|Diazepam Buccal Soluble Film 5, 7.5,10, 12.5,15 or 17.5 mg with individual dose determined according to age and weight category|The subjects in this study administered DBF themselves or with the help of a caregiver, (trained by the study site staff in study drug administration and documentation) in the same setting as they typically used the diazepam rectal gel or other rescue medication, without the presence of study staff.
15928865|NCT03428347|Biological|GamEMab|drug for emergency prevention of Ebola based on recombinant monoclonal antibodies
15928866|NCT03428334|Drug|Oral roflumilast|Roflumilast, a phosphodiesterase 4 (PDE4) inhibitor is approved worldwide (including Hong Kong) for treatment of severe chronic obstructive pulmonary disease (COPD) with frequent exacerbations. Roflumilast has been shown to have anti-inflammatory effect in patients with COPD, with significant reduction of sputum absolute neutrophil count, IL-8 and neutrophil elastase compared with placebo treatment. Roflumilast can also improve the lung function parameters in patients with COPD and reduce the rate of moderate-to-severe exacerbations.
15928867|NCT03428308|Other|Screening|Each individual general practitioner reviews his/her record system and detects patients who meet the inclusion criteria. Patients who meet these criteria will be invited to participate in the project.
15928868|NCT03428308|Other|Treatment|Patients who are diagnosed with one or more of the selected somatic diseases receive an individualized course of treatment in general practice, primarily focusing on initiation and maintenance of medical treatment, and complying with current clinical guidelines and course programmes. Treatment goals are set in active co-operation with the patient and his/her family and with supervision and support from the Mental Health Centre Copenhagen, clinical pharmacologists and relevant staff from the municipality in terms of contact/support persons.
15928869|NCT03428295|Device|Dose Safety AP system|Device will be used to automatically dose insulin
15928870|NCT03428282|Procedure|VR Box|Distraction will be made during the injection of the drug using this method.
15928871|NCT03428282|Procedure|Tablet Device|Distraction will be made during the injection of the drug using this method
15928872|NCT03428282|Drug|Anesthesia|Anesthesia will be obtained by injecting the drug into the oral mucosa before performing the dental treatment.
15928873|NCT03428269|Other|simulation by gaming (LabForGames Warning)|comparison of the efficacy of two educational methods to improve the clinical reasoning skills of nursing students facing patient deterioration
15928874|NCT03428269|Other|traditional education|comparison of the efficacy of two educational methods to improve the clinical reasoning skills of nursing students facing patient deterioration
15928875|NCT03428256|Device|Optiflow and THRIVE technique|Nasal high flow humidified oxygen
15928876|NCT03428256|Device|Standard anaesthetic face mask|Oxygen delivery via an anaesthetic facemask
15928877|NCT03428243|Device|truSculpt|Device comparison of Circumference measurement at Baseline vs 18 months post treatment
15928878|NCT03428230|Drug|30 mg Paracetamol 3% (1 mL)|Single administration by intrathecal injection just before spinal anaesthesia. The injection will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.
15928879|NCT03428230|Drug|60 mg Paracetamol 3% (2 mL)|Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.
15928880|NCT03428230|Drug|90 mg Paracetamol 3% (3 mL)|Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Paracetamol followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Paracetamol will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.
15928881|NCT03428230|Drug|Placebo, 0.9% saline solution|Single administration by intrathecal injection just before spinal anaesthesia. The injections will be performed according to the hospital procedures. For the intrathecal injection of Placebo followed by the intrathecal injection of the anaesthetic, two needles will be used: one introducer needle, which will serve to introduce the second needle through the skin, plus one intrathecal Pencil point needle (27-G or 25-Gauge or Reganesth or Nizell needle) to which the first syringe containing Placebo will be attached first, followed by the second syringe with the anaesthetic. In this way only one intrathecal puncture will be performed. Lumbar puncture will be done according to the standard hospital procedures.
15928882|NCT03428230|Drug|NIMP: Chloroprocaine HCl 1% (10 mg/mL), solution for injection|Immediately after intrathecal administration of the Paracetamol dose or Placebo, all patients will receive a single intrathecal dose of Chloroprocaine HCl 1% according to the Summary of Product Characteristics indications. Time interval between the 2 administrations should not exceed 2 min.
15928883|NCT03428217|Drug|CB-839|Oral glutaminase inhibitor
15928887|NCT03428204|Procedure|Balloon dilation during 300 seconds|Percutaneous angioplasty with balloon dilation during 300 seconds as a method for percutaneous treatment of femoropopliteal artery lesions
15928888|NCT03428191|Drug|Remifentanyl+Dexmedetomidine|In all patients, dexmedetomidine was injected at a bolus of 0.6 mg/kg and then continuously infused at 0.6 ug/kg/h using the conventional continuous microinfusion pump. the target Effect-site concentration of remifentanil was determined by sequential method.
15928889|NCT03428178|Drug|rAAV2-ND4|rAAV2-ND4 of vitreous cavity injection
15928890|NCT03428165|Other|HCG|250 μg/0.5ml choriogonadotropine alpha, Ovitrelle, Merck Serono
15928891|NCT03428152|Procedure|superior hypogastric block|superior hypogastric blockade during surgery
15928892|NCT03428139|Procedure|pulsed radiofrequency|Each patient in this group was treated with PRFT on the affected DRG at 42°C for 120 seconds.
15928893|NCT03428139|Drug|pulsed radiofrequency plus alpha lipoic acid|Each patient in this group was treated with PRFT as in group I plus oral alpha lipoic acid (ALA) 600 mg (Thiotacid 600 mg, EVA PHARMA, Egypt) three times per day (1800mg/day) for 3 weeks then 600mg once daily for 2 weeks.
15928894|NCT03428126|Drug|Durvalumab|Dose Escalation and Dose Expansion Dose: 1500 mg by vein every 4 weeks in a 28 day cycle.
15928895|NCT03428126|Drug|Trametinib|"Dose Escalation Starting Dose: 2mg by mouth daily in a 28 day cycle.
~Dose Expansion Dose: MTD from Dose Escalation."
15928896|NCT03428113|Other|Bladder Volume Measurement bladder scanner RN|Measure Urine Volume with Bladder Scanner by RN
15928897|NCT03428113|Other|Bladder Volume Measurement Ultrasound APRN|Measure Urine Volume with Point of Care Ultrasound by APRN
15928898|NCT03428113|Other|Bladder Volume Measurement bladder scanner APRN|Measure Urine Volume with Bladder Scanner by APRN
15928899|NCT03428113|Other|Bladder Volume Measurement Ultrasound MD|Measure Urine Volume with Point of Care Ultrasound by MD
15928900|NCT03428113|Other|Intermittent Straight Catheterization|Measure Urine Volume with Intermittent Straight Catheterization
15928901|NCT03428100|Drug|Baricitinib|Administered orally.
15928902|NCT03428100|Drug|Placebo|Administered orally.
15928903|NCT03428100|Drug|Topical corticosteroid|Administered as standard-of-care.
15928904|NCT03428074|Procedure|Surgeries|Minimally invasive surgeries of Ivor-Lewis and Mckeown
15928905|NCT03428061|Other|Integrated care for cardiovascular risk management|Disease management program for the prevention of cardiovascular diseases
15928906|NCT03428048|Procedure|Hybrid procedure|Ablation of the posterior aspect of the heart, an area thought to be the origin of chaotic arrhythmias in persistent Afib patients.
15928907|NCT03428048|Procedure|Endocardial ablations|ablations occurring inside the heart isolating the pulmonary veins - blocking energy from creating irregular or chaotic heart beats with use of a catheter
15928908|NCT03428048|Procedure|left atrial appendage occlusion|A procedure to isolate the left atrial appendage of the heart. this anatomic body is the origin of clot formation which can lead to stroke. the clot formation as a result of Afib
15928909|NCT03428035|Other|Package Insert|Modified package insert of Ibuprofen given postprocedural as pain medication
15928910|NCT03428022|Drug|Apatinib（Tab. 500mg/d） combined with EGFR-TKI（as previously）|Patients with advanced non-small cell lung cancer (NSCLC) who had treated with EGFR-TKI and progressed slowly because of resistance are underwent with apatinib mesylate and continuous EGFR-TKI.
15928911|NCT03428009|Other|Magnetic Resonance Imaging|Study interventions are minimal risk.
15928912|NCT03427996|Procedure|Rotational atherectomy|Percutaneous coronary intervention with rotational atherectomy
15928913|NCT03427983|Procedure|Hydrodissection|Additional 3cc's of saline is used to establish an increase in hydrodissection during routine treatment.
15928914|NCT03427983|Procedure|Regular Injection|Corticosteroid and lidocaine injection without additional saline is used as routine treatment.
15928915|NCT03427970|Behavioral|observation|Control group will receive the standard of care according to the Scoliosis Research Society criteria: observation for patients with curves between 10°- 25°.
15928916|NCT03427970|Behavioral|three-dimensionally integrated exercise for scoliosis|Experimental group will receive a modified physiotherapeutic scoliosis specific exercises --the three-dimensionally integrated exercise for scoliosis program, which include auto-correction in 3D, postural correction, breathing training, resistance training, muscle fascia releasing, functional activities, balance training, core stability training, proprioceptive input exercises and patient education. Auto-correction exercise in 3D will combine with specific breathing mode, isometric training to correct abnormal spinal physiological curvatures in sagittal plane, and accompany with wedge pad to modify humpback, waist asymmetry, pelvic rotation in horizontal. While in coronal plane, longitudinal axial stretching, pelvic adjustments will be conducted to reduce the lateral curvature.
15928917|NCT03427957|Diagnostic Test|Endometrial biopsy with the new hysteroscopic grasper with knurled terminal end and cutting jaws|Hysteroscopic endometrial biopsy performed through the new grasper with knurled terminal end and cutting jaws.
15928918|NCT03427957|Diagnostic Test|Endometrial biopsy with the hysteroscopic spoon grasper|Hysteroscopic endometrial biopsy performed through the spoon grasper.
15928919|NCT03427957|Diagnostic Test|Endometrial biopsy with the hysteroscopic alligator grasper|Hysteroscopic endometrial biopsy performed through the alligator grasper.
15928920|NCT03427944|Drug|Calcium Dobesilate group|Calcium dobesilate was used to treat patients with chronic renal failure on the basis of conventional treatment.
15928921|NCT03427944|Drug|Conventional Treatment group|Conventional treatment were used to treat patients with chronic renal failure.
15928922|NCT03427931|Other|Continuous Glucose Monitor (CGM)|Study subjects will collect Continuous Glucose Monitor data for a minimum of 28 days but may continue for up to 3 months.
15928923|NCT03427918|Behavioral|Mindfulness-Based Sex Therapy|Mindfulness-Based Sex Therapy in an integration of psychoeducation, sex therapy, and mindfulness-based skills.
15928924|NCT03427905|Procedure|Lipoaspiration|Procedure: Lipoaspiration of fat and processing for the isolation of SVF Procedure: Transplantation
15928925|NCT03427905|Procedure|Transplantation|Procedure: Lipoaspiration of fat and processing for the isolation of SVF and culture for the obtention of ADSCS Procedure: Transplantation
15928926|NCT03427892|Drug|Brexpiprazole|Brexpiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders.
15929282|NCT03425006|Biological|Pembrolizumab|a highly selective humanized monoclonal antibody (mAb)
15928927|NCT03427879|Drug|Low flavonoid beverage|A low flavonoid, sports nutrition recovery beverage will be prepared from milk (78%), sugar (8.6%), maltodextrin (8.6%), placebo blueberry powder (2.4%), alkalized cocoa powder (1.6%), and whey protein isolate (0.6%). The beverage will contain approximately 5mg flavonoids per serving.
15928928|NCT03427879|Drug|High flavonoid beverage|A high flavonoid, sports nutrition recovery beverage will be prepared from milk (78%), sugar (8.6%), maltodextrin (8.6%), blueberry powder (2.4%), cocoa powder (1.6%), green tea extract (0.1%) and whey protein isolate (0.6%). The beverage will contain approximately 620 mg flavonoids per serving.
15928929|NCT03427866|Drug|Ruxolitinib|Ruxolitinib is a medication that blocks certain proteins called tyrosine kinases. Specifically, it blocks tyrosine kinases called JAK2. The JAK2 pathway is over active in the disease, acute myeloid leukemia.
15928930|NCT03427853|Drug|LY06006|LY06006 18mg, 60mg, 120mg subcutaneous injection
15928931|NCT03427853|Drug|Placebos|Placebo subcutaneous injection
15928932|NCT03427840|Procedure|Procedure/Surgery: superior hypogastric block|superior hypogastric blockade during surgery
15928933|NCT03427827|Drug|Camrelizumab|Camrelizumab is an antibody targeting PD-1 developed by Jiangsu Hengrui Medicine, China.
15928934|NCT03427814|Drug|pamiparib|60 mg PO BID
15928935|NCT03427814|Drug|Placebo|60 mg PO BID
15928936|NCT03427801|Drug|Erythropoiesis-Stimulating Agent|erythropoiesis-stimulating agent: Mircera or Darbepoietin
15928937|NCT03427788|Drug|BAY2328065|Doses from 2.25-700 mg once daily in an escalating manner as liquid service formulation (LSF) or tablets
15928938|NCT03427788|Drug|Placebo|Matching placebo, once daily in an escalating manner as LSF or tablets
15928939|NCT03427775|Combination Product|multimodal perioperative pain protocol (MP3)|administration of gabapentionoid, acetaminophen, non steroidal anti-inflammatory drugs around the clock in addition to the peripheral nerve block offered before surgery
15928940|NCT03427762|Other|Rehabilitation|"Healthy cycling group: The group participates in 5 weeks of intensive cycling therapy.
~Healthy xbox group: The group participates in 5 week intensive xbox therapy Healthy controll group: The group does not take any kind of therapy. PD group: We have already analyzed the results of our group, and we will compare their results with the results of healthy groups."
15928941|NCT03427736|Drug|Ketorolac Tromethamine|IV ketorolac will be given per standard of care, not prescribed for this study
15928942|NCT03427736|Drug|Hydromorphone|IV Hydromorphone will be given per standard of care, not prescribed for this study
15928943|NCT03427723|Device|Accuvein®400|The intervention comes down to the randomization of the standard treatment versus Accuvein for peripheral intravenous cannulation
15928944|NCT03427723|Other|Standard care|The intervention comes down to the randomization of the standard treatment versus Accuvein for peripheral intravenous cannulation
15928945|NCT03427710|Drug|CiVi007|cholesterol lowering drug
15928946|NCT03427710|Other|Placebo|matching placebo to CiVi007
15928947|NCT03427697|Device|Virtual reality and accommodation relax techniques in combination|The children will be given head-mounted video display to watch video at break of classes, 40 minutes per day in total. The video will be shown by virtual reality and accommodation relax techniques in combination.
15928948|NCT03427684|Radiation|Hypo-fractionated radiotherapy|Hypo-fractionated radiotherapy with fraction >2Gy .
15928949|NCT03427684|Drug|S1|S-1 80mg/m2/day, orally intake on radiotherapy days.
15928950|NCT03427671|Device|Occlusin 500 Microspheres|Occlusin 500 microspheres will be administered using a catheter directed to the uterine vasculature using fluoroscopy. The microsphere suspension will be administered to a near-stasis endpoint.
15928951|NCT03427658|Behavioral|Sweet food consumption|Comparison of the impacts of sweet and non-sweet food consumption
15928952|NCT03427645|Behavioral|Decision tool|A tailored web-based stroke decision support intervention. This web-based tool will be developed for use by the surrogate decision maker during the acute stroke hospitalization and will be designed to facilitate high quality patient-centered decisions and minimize adverse effects on the surrogate.
15928953|NCT03427632|Drug|Bone Cements|patents in PVP group will get injected with bone cement inside the collapsed malignant vertebra
15928955|NCT03427606|Procedure|Continuous Locked Suture vs Traditional 5-points suture for Laparoscopic Sacral Colpopexy|To verify if the operative time of a standard laparoscopic sacral colpopexy associated to subtotal hysterectomy for the treatment of POP could be further reduced using continuous locked suture vs traditional 5-points suture for mesh fixation
15928956|NCT03427593|Genetic|FACS analyses|FACS analyses
15928957|NCT03427593|Genetic|Target Sequencing by NGS ( Next-generation sequencing)|Target Sequencing by NGS ( Next-generation sequencing)
15928958|NCT03427593|Genetic|Whole Exome Sequencing|Whole Exome Sequencing
15928959|NCT03427580|Behavioral|MERIT|Metacognitive Reflection and Insight Therapy
15928960|NCT03427567|Procedure|Sublobar dissection|Sublobar dissection plus lymphadenectomy
15928961|NCT03427554|Drug|Tretinoin cream 0.1%|Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)
15928962|NCT03427554|Drug|RETIN-A® Cream|RETIN-A® (Tretinoin) Cream (Valeant)
15928963|NCT03427554|Drug|Vehicle of the test product|Vehicle for Tretinoin cream 0.1% (Taro Pharmaceuticals Inc.)
15928964|NCT03427541|Procedure|Surgeries|Surgeries
15928965|NCT03427528|Behavioral|Fathers and Babies (FAB)|Partners of female clients will receive the FAB texts that align with the original MB 1-on-1 intervention. The female partners will receive MB-TXT curriculum (i.e., MB 1-on-1 plus MB-TXT) and their male partners will receive the Home visitors will be responsible for sending texts to both their female clients and the clients' male partners.
15928966|NCT03427528|Behavioral|MB 1-on-1 plus TXT|Female clients will receive the MB-TXT curriculum (i.e., MB 1-on-1 plus MB-TXT) and their male partners will receive the FAB texts that align with the original MB 1-on-1 intervention.Home visitors will be responsible for sending texts to both their female clients and the clients' male partners.
15928967|NCT03427515|Dietary Supplement|Lactobacillus rhamnosus GG (ATCC 53103)|30 days of supplementation, 6x10^9 CFU/day
15928968|NCT03427515|Dietary Supplement|Saccharomyces boulardii (CNCM I-1079)|30 days of supplementation, 5x10^9 CFU/day
15928969|NCT03427515|Dietary Supplement|Placebo|30 days of supplementation
15961181|NCT03179878|Drug|SYNB1020|Investigational Product
15928970|NCT03427502|Drug|Bupivacaine-epinephrine|10 ml of 0.5% bupivacaine with 1:2,00,000 adrenaline. For children less than 12 years of age, 0.25% bupivacaine with 1:2,00,000 adrenaline
15928971|NCT03427502|Drug|normal saline|normal saline
15928972|NCT03427476|Drug|CTT1057|"Cohort A: Single IV dose (370 MBq, or 10 mCi). Combined PET/MR or PET/CT imaging (kidney + whole body) will be performed following tracer injection. Patients in cohort A will undergo metastatic lesion biopsy (plus lymph node dissection) within 12 weeks after CTT1057 PET.
~Cohort B: Single IV dose (370 MBq, or 10 mCi). Combined PET/MR or PET/CT imaging (kidney + whole body) will be performed following tracer injection. Patients in cohort B (renal cell carcinoma) will have nephrectomy within 12 weeks of CTT1057 PET imaging."
15928973|NCT03427463|Drug|receiving 0.1 mg IT morphine|Patients will receive the standard of care dose 0.1 mg of intrathecal morphine
15928974|NCT03427463|Drug|recieving 0.05 mg IT morphine|Patients will receive 0.05 mg of intrathecal morphine
15928975|NCT03427450|Diagnostic Test|Blood draw|Blood collected will be processed on Parsortix PC1 system for capture and harvest of circulating tumor cells to be used in subsequent evaluations.
15928976|NCT03427437|Drug|Bupivacaine|caudal block was performed by conventional and ultrasound method with %0,25 bupivacaine + 1/200000 adrenalin
15928977|NCT03427437|Drug|Adrenalin|caudal block was performed by conventional and ultrasound method with %0,25 bupivacaine + 1/200000 adrenalin
15928978|NCT03427437|Device|Ultrasound|caudal block was performed by ultrasound method
15928980|NCT03427385|Drug|Ropivacaine 0.5%|The volume of local anesthetic Ropivacaine 0.5% will be determined by the response (success or failure of block, 30 minutes after local anesthetic injection) of the previous patient in that group. Block success is defined as an absence of ice sensation in the knee within 30 min of ropivacaine administration accompanied by tolerance to tetanic electrical stimulation (TES) at 60 mA(milliamp) for 5 seconds.
15928981|NCT03427372|Behavioral|anxiety scale, depression scale|post spinal puncture headache and backache will be assess by using visual analogue scale, anxiety will assess by beck anxiety scale, depression mood will assess by beck depression scale
15928982|NCT03427359|Drug|cisplatin, capecitabine|Experimental arm patients received 3 cycles of induction chemotherapy (cisplatin 80mg/m2, day 1; oral capecitabine 1000mg/m2 twice daily from day1-14, repeated every 3 weeks) followed by concomitant cisplatin (100mg/m2,day1,every 3 weeks) for a total of 2 cycles with radiotherapy.
15928983|NCT03427346|Procedure|Endoscopic mucosal resection|Endoscopic resection is carried out using a double-channel scope. The lesion borders are marked with a coagulator. Saline liquid and sometimes epinephrine are injected into the submucosal layer to swell the area containing the lesion and elucidate the markings. The resected mucosa is lifted, then trapped and strangulated with a snare, and subsequently resected by electrocautery. Another method of EMR employs the use of a clear cap and prelooped snare inside the cap. After insertion, the cap is placed on the lesion and the mucosa containing the lesion is drawn up inside the cap by aspiration. The mucosa is caught by the snare and strangulated, and finally resected by electrocautery.
15928984|NCT03427346|Procedure|Endoscopic submucosal dissection|After circumferential cutting of the surrounding mucosa of the lesion, fluid is injected into the submucosa to elevate the lesion from the muscle layer, and the connective tissue of the submucosa beneath the lesion is dissected subsequently.
15928985|NCT03427333|Device|The Rook® Epicardial Access Kit|Use of the Rook Epicardial Access Kit to gain access to the normal, non distended pericardial space.
15928986|NCT03427320|Drug|[131]I-IAZA|Injection of a single dose of 185MBq ( range 150-220MBq) of [131]I-IAZA prior to whole body imaging acquisition at 0-1 hrs,1-3 hrs , 4-8 hrs,19-36 hrs,41-72 hrs and 6-8 days post-injection. SPECT CT of target lesion(s) will be acquired at 19-36 hrs post injection.
15928987|NCT03427294|Other|Delphi study|Delphi study on the optimal rehabilitation pathway following lumbar arthrodesis
15928988|NCT03427281|Behavioral|questionnaire|questionnaire to assess the patterns of postoperative bracing use by spinal surgeons in Belgium
15928989|NCT03427268|Drug|PM060184|"PM060184: 9.3 mg/m2 PM060184 i.v. as a 30-minute infusion via a central or peripheral venous catheter.Dose can be rounded to the first decimal point.
~PM060184 will be administered on Day 1 and Day 8 q3wk. (Three weeks=one treatment cycle)."
15928990|NCT03427255|Behavioral|CBT group treatment-plus|The CBT group program-plus consists of 3 1- hr CBT couple sessions and 10 2-hr CBT group sessions over a period of 6 months. The manualized treatment comprise, pain- and sexual education, relaxation and gradual exposure exercises as well as sensate focus and sexual communication exercises for the couple. 6-8 women participate in each group. Two psychologists conduct the couple and group sessions.
15928991|NCT03427255|Other|Waiting-list control condition|Waiting-list control condition during length of active treatment (6 months).
15928992|NCT03427242|Drug|Apatinib|oral apatinib 750mg qd
15928993|NCT03427229|Biological|Single-infusion FMT|Patients will receive a single fecal infusion by colonoscopy
15928994|NCT03427229|Drug|Vancomycin (before randomization)|Vancomycin is administered in all patients for 3 days before randomization. Then vancomycin is stopped and patients are randomized to single-infusion FMT or multiple-infusion FMT.
15928995|NCT03427229|Biological|multiple-infusion FMT|Patients will receive multiple fecal infusions by colonoscopy
15928996|NCT03427216|Drug|Baclofen/diazepam|Vaginal suppository placed once daily, patients will record pelvic pain daily on a VAS scale, sexual satisfaction and quality of life on a standardized questionnaire weekly
15928997|NCT03427216|Drug|Vaginal placebo|Vaginal suppository placed once daily, patient will record pelvic pain daily on a VAS scale, sexual satisfaction and quality of life on a standardized questionnaire weeky.
15928998|NCT03427203|Device|SenSura Mio|SenSura Mio is a marked ostomy device which is used as the comparator in this study
15928999|NCT03427203|Device|Coloplast Ostomy device 1|Coloplast Ostomy device 1 a newly developed ostomy device
15929000|NCT03427203|Device|Coloplast Ostomy device|Coloplast Ostomy device 2 a newly developed ostomy device
15929001|NCT03427203|Device|Coloplast Ostomy device 3|Coloplast Ostomy device 3 a newly developed ostomy device
15929041|NCT03426943|Biological|Ultrafiltrate sampling|All patients will have ultrafiltrate sampling to assess cytokine levels
15929042|NCT03426943|Device|CVVH using oXiris™ filter|Patients included in the experimental arm will have renal replacement therapy by performing CVVH using oXiris™ filter
15929002|NCT03427190|Other|APSOM vs Control|In complement to actions described in the control arm, the patient's general practitioner (GP) and the patient him/herself will be contacted within 21 days of hospital discharge in order to organize an appointment between them two; this consultation is expected to take place between day 22 and day 45 after hospital discharge. If the patient does not have a GP, a health-care professional (HCP) will be provided. .GP (or HCP) will also be contacted at 6 and 13 months.
15929003|NCT03427177|Behavioral|mychoice|The mychoice communication tool begins to prepare patients to participate in a personal and tailored discussion with their provider about clinical trials as a potential treatment option. It is also customized to address the concerns of those least likely to participate, instead of providing a more general look at clinical trials- a common trait of other available tools.
15929004|NCT03427164|Procedure|Transjugular Intrahepatic Portosystemic Shunt|The TIPS procedures creates an artificial shunt from the portal vein to the hepatic vein. TIPS allows blood from the congested portal circulation to bypass the fibrotic liver and directly enter the systemic circulation.
15929005|NCT03427151|Drug|IPP-201101|200 mcg of IPP-201101 will be administered subcutaneously every 4 weeks for 24 weeks.
15929006|NCT03427138|Behavioral|Jasper|Families in the joint attention intervention will receive 10 weeks of the JASPER (Joint Attention Symbolic Play Engagement Regulation) protocol. JASPER is a treatment approach based on a combination of developmental and behavioral principles developed by Dr. Connie Kasari at the Center for Autism Research and Treatment, at University of California, Los Angeles. Our research staff will be trained on the specific techniques of JASPER guided by Connie Kasari (consultant on project) and her colleagues The study's intervention involves 2 days/week of 60-minute sessions with a trained experimenter (which may take place in the lab or home, depending on the needs of the family). The primary goal for the intervention will be to increase the frequency and range/variety of joint attention and to advance the child to higher levels (e.g., from requesting to initiating joint attention acts).
15929007|NCT03427138|Behavioral|Parent Education|Families in the parent education intervention. Parent education will be provided in group sessions. During the sessions information is presented about ASD, how to deal with behavioral difficulties and available services, and parents are given an opportunity to share experiences. Parents will attend a weekly session for 10 weeks. 10 different topics will be discussed, which include: causes and symptoms of autism, diagnosis process, treatment options, enhancing communicative abilities in children with autism, emotion regulation, dealing with distress, correcting behavior difficulties, applying structure and routines.
15929008|NCT03427125|Drug|Tenapanor|Active Drug
15929009|NCT03427125|Drug|Placebo|Inactive Drug
15929010|NCT03427125|Drug|Sevelamer Carbonate|Active control
15929011|NCT03427112|Device|Xin1 Humerus System|"Retrospective assessment of the surgical handling and performance of the X-ray-based tracking and navigation system Xin1 Humerus system evaluated from 10 proximal humerus plate fixations"
15929012|NCT03427099|Behavioral|Rehabilitation with a biopsychosocial focus|Rehabilitation with a biopsychosocial focus
15929013|NCT03427099|Behavioral|Control group|usual care
15929014|NCT03427086|Drug|Biotin|High dose biotin
15929015|NCT03427086|Drug|Placebo Oral Tablet|Placebo tablet similar in shape and size to the biotin tablet
15929016|NCT03427073|Drug|ALM201|Drug: ALM201 administered subcutaneously
15929017|NCT03427060|Drug|Coversin|Coversin - 22.5mg followed by 45mg for 6 months.
15929020|NCT03427034|Device|BladderLight®|Using a cell collection device to look for the presence of bladder cancer cells
15929021|NCT03427021|Drug|Oxaliplatin|Infusion
15929022|NCT03427008|Other|mHealth Intervention|The mHealth app will allow transplant recipients to see their medication regimen, record themselves taking every dose, report side effects or symptoms, visualize their treatment progress, access educational content, and track appointments. This information is encrypted and transmitted to a HIPAA-secure web portal for providers to review.
15929023|NCT03426995|Drug|Placebo|Placebo will be administered as a matching oral solution or matching capsule to study drug GSK3358699, during Part A and C once daily
15929024|NCT03426995|Drug|GSK3358699|GSK3358699, will be administered from 1 mg to 45 mg as an oral solution (1 to 10 mg) or as a capsule (3 to 45 mg), in Part A, B and Part C once daily.
15929025|NCT03426995|Biological|GM-CSF|The GM-CSF will be administered as an intravenous infusion to subjects as 60 microgram per meter^2 in Part A (Day 1) and Part C (Day 14).This will be administered for 2 hours approximately, no later than 24 hours post -dose of the GSK3358699 or placebo in Part C
15929026|NCT03426995|Biological|LPS|LPS will be administered as an intravenous injection to subjects not exceeding 0.75 nanogram per kilogram in Part A (Day 1) and Part C (Day 14). This will be administered no later than 24 hours post -dose of the GSK3358699 or placebo in Part C.
15929027|NCT03426995|Other|Cantharidin|This will be applied as a topical application with 0.7% cantharidin liquid which will be diluted with acetone to 0.2%.
15929028|NCT03426982|Drug|Unfractionated heparin|Infusion dose of unfractionated heparin was adjusted by APTT
15929029|NCT03426982|Drug|Unfractionated heparin|Infusion dose of unfractionated heparin was adjusted by anti-Xa
15929030|NCT03426969|Drug|Cyclophosphamide|Given IV
15929031|NCT03426969|Biological|Filgrastim|Given SC
15929032|NCT03426969|Drug|Fludarabine Phosphate|Given IV
15929033|NCT03426969|Procedure|Hematopoietic Cell Transplantation|Undergo HCT
15929034|NCT03426969|Drug|Melphalan|Given IV
15929035|NCT03426969|Drug|Mycophenolate Mofetil|Given PO
15929036|NCT03426969|Drug|Tacrolimus|IV or PO
15929037|NCT03426969|Radiation|Total-Body Irradiation|Undergo TBI
15929038|NCT03426956|Dietary Supplement|Glucose|Ingestion of glucose (50 g) dissolved in 200 ml water.
15929039|NCT03426956|Dietary Supplement|Glucose + Canagliflozin|Ingestion of glucose (50 g) dissolved in 200 ml water combined with the SGLT-1/SGLT-2 inhibitor canagliflozin.
15929040|NCT03426943|Biological|Arterial blood sampling|All patients will have arterial blood sampling to assess pre-filter and post-filter plasma endotoxin mass and activity and plasma cytokine levels
15929043|NCT03426943|Device|CVVH using PrismafleX HF1400 filter|Patients included in the experimental arm will have renal replacement therapy by performing CVVH using PrismafleX HF1400 filter
15929044|NCT03426930|Other|self-evaluation of the Body Mass Index|Evaluation of the Body Mass Index before and after the treatment
15929045|NCT03426930|Other|Cognitive-behavioral psychotherapies|Cognitive-behavioral psychotherapies before and after the treatment
15929046|NCT03426904|Drug|Neoadjuvant FOLFOX|4 cycles of FOLFOX neoadjuvant chemotherapy and 8 cycles of postoperative chemotherapy
15929047|NCT03426904|Drug|Conventional adjuvant FOLFOX|12 cycles of postoperative FOLFOX chemotherapy
15929052|NCT03426878|Other|Modified genetic counseling|After participants at high risk for a hereditary cancer syndrome receive exome sequencing, they will receive modified genetic counseling to help them understand the results.
15929053|NCT03426878|Other|Traditional genetic counseling|After participants at high risk for a hereditary cancer syndrome receive exome sequencing, they will receive traditional genetic counseling to help them understand the results.
15929054|NCT03426865|Drug|Axumin PET scan|PET scan prior to RPLND
15929055|NCT03426852|Other|No intervention|No intervention
15929056|NCT03426839|Diagnostic Test|Coagulation tests|
15929057|NCT03426826|Biological|FMT versus placebo|"Biological/Vaccine: Fecal Microbial Transplant versus placebo Fecal Transplant via endoscopy.
~Other Names:
~FMT"
15929058|NCT03426813|Other|Historical control group for early mobilization|
15929059|NCT03426800|Other|Acupuncture and training|Acupuncture twice in the week in 3 weeks combined with training in 6 weeks
15929060|NCT03426787|Behavioral|Decision Aid|Participants will have the option to view a web or paper-based version of the decision aid.
15929061|NCT03426774|Device|Gentle Jogger|Passive Simulated Jogging device (Gentle Jogger)
15929062|NCT03426774|Device|Gentle Jumper|Passive Simulated Jumping Device ( Gentle Jumper)
15929063|NCT03426761|Drug|Dalbavancin|Dalbavancin 1,500mg intravenously every fourteen days for two to four infusions
15929064|NCT03426761|Drug|Vancomycin|Examples of standard of care arm; infusions one to three times per day depending on the antibiotic for a total of three to eight weeks
15929065|NCT03426748|Radiation|Low dose rate prostate brachytherapy|Permanent implantation of radioactive Iodine-125 seeds under anesthesia with ultrasound guidance
15929066|NCT03426748|Radiation|High dose rate prostate brachytherapy|Temporary implantation of radioactive material into the prostate in the form of a stepping source of Iridium 192 that travels through 16-18 needles or catheters strategically placed through the prostate
15929067|NCT03426735|Other|Dry heat|Dry heat will be applied in the extravasation zone for 10 minutes. Let it rest for 20 and proceed to make a second application of dry cold for another 10 minutes. The control is after 24 hours.
15929068|NCT03426735|Other|Dry cold|Dry cold will be applied in the extravasation zone for 10 minutes. Let it rest for 20 and proceed to make a second application of dry cold for another 10 minutes. The control is after 24 hours.
15929069|NCT03426722|Drug|L-carnitine|"L-carnitine VS Placebo is randomized (1:1)
~L-carnitine 500mg TID(PO),
~First evaluation will be performed at 8 weeks and then unblinding will be done. If symptoms continue after treatment, dose escalation in L-carnitine group by 1000mg TID (PO). If symptoms continue after treatment in Placebo group, L-carnitine 500mg TID(PO) will be given."
15929070|NCT03426722|Drug|Placebo|Placebo 500mg TID(PO)
15929071|NCT03426709|Behavioral|Low intensity Internet-delivered psychotherapy|The online intervention will be individual and interactive, which will be supported by multimedia material (videos, sound recordings, etc.) and will have internet support. The estimated duration of the program is 8 weeks. Low Intensity Internet-delivered psychotherapy: Psychoeducation, Healthy living habits, Behavioral activation, Positive Psychology, Mindfulness and Compassion
15929072|NCT03426696|Behavioral|psychological condition|Graves ́ ophthalmopathy quality of life questionnaire, Symptom checklist 90(SLC-90), Hamilton anxiety scale(HAMA), Somatic self-rating scale(SSS), MATRICS Consensus Cognitive Battery (MCCB), Hamilton depression scale(HAMD)
15929073|NCT03426683|Other|Intestinal Microbiota Transplantation|the bacteria will be transplanted to mid-gut by nose-jejunum nutrition tube. Patients in this study will be assigned to receive standardized IMT three times or traditional medicine and would be followed up for at least 3 year.
15929074|NCT03426670|Device|OraQuick HIV Self-Test|OraQuick® HIV Self-Test is an in-vitro diagnostic medical device that is used for self-testing of antibodies for HIV-1 and HIV-2 in oral fluid. This test is intended as an aid to detect antibodies to HIV-1 and HIV-2 from infected individuals.
15929190|NCT03425669|Device|Stochastic Vestibular Stimulation|Stochastic vestibular stimulation will be given by electric stimulation through electrodes place over the mastoid processes behind each ear. Auditory stimulation with stochastic white noise will be administrated through ear phones.
15929075|NCT03426657|Combination Product|Durvalumab + Tremelimumab + RT|Patients with an increased CD8+ tumor infiltrating immune cell density and at least clinically stable disease will receive radioimmunotherapy with the PD-L1 Inhibitor Durvalumab and the CTLA4-Inhibitor Tremelimumab (altogether 4 doses q4w including the induction dose) followed by maintenance therapy with Durvalumab (8 additional doses q4w).
15929076|NCT03426644|Behavioral|Mobile Sleep and Growth Study|The intervention is designed to test if sleep tips delivered by text messages can aid with reaching time in bed targets. And if additional motivational text messages can further aide with reaching time in bed targets.
15929077|NCT03426631|Drug|Placebo oral capsule|Placebo capsule 30 minutes before sleep
15929078|NCT03426631|Drug|DAW1033B2 oral capsule|DAW1033B2 capsule 30 minutes before sleep
15929079|NCT03426618|Other|Non-interventional|Non-interventional
15929080|NCT03426605|Drug|Open Label LAM-003|LAM-003
15929081|NCT03426592|Drug|Vitamin D3, 10000 Intl Units Oral Capsule|"Vitamin D capsule. Over-encapsulated to mimic placebo oral capsule.
~Eligible study participants will be randomized 1:1 to vitamin D or placebo one capsule daily from week 0 to week 24. All participants will be advised to achieve 1 gram daily dietary calcium intake whilst on study.
~Blood and urine will be taken at 0, 12, 24 and 36 weeks to evaluate the primary and secondary endpoints.
~Rectal swabs will be taken at 0, 24 and 36 weeks.
~All participants will continue antiretroviral therapy throughout the study."
15929082|NCT03426592|Drug|Placebo oral capsule|"Capsule containing oleic acid. Over-encapsulated to mimic vitamin D3 capsule.
~Eligible study participants will be randomized 1:1 to vitamin D or placebo one capsule daily from week 0 to week 24. All participants will be advised to achieve 1 gram daily dietary calcium intake whilst on study.
~Blood and urine will be taken at 0, 12, 24 and 36 weeks to evaluate the primary and secondary endpoints.
~Rectal swabs will be taken at 0, 24 and 36 weeks.
~All participants will continue antiretroviral therapy throughout the study."
15929083|NCT03426579|Device|NeuroSENSE ®in children|Before induction of anesthesia NeuroSENSE ® monitoring will be applied to all subjects.General anesthesia with dexmedetomidine and remifentanil is titrated based on the evaluation of respiratory clinical signs (cough, spasm, movement) and immobility of the vocal cords. The anesthesiologist performing anesthesia will be blinded for the Wavelet-based Anesthetic Value for Central Venous System (WAVCNS) index assessed by NeuroSENSE ® and will adjust dexmedetomidine according to clinical signs, which is standard of care. Retrospectively data obtained by NeuroSENSE ® will be compared to evaluate whether they are useful in predicting upcoming unwanted airway reflexes.
15929084|NCT03426566|Other|retrospective observational study with no intervention|no intervention
15929085|NCT03426553|Biological|Riboflavin+UV RBC|35 patients who met all inclusion and exclusion criteria received transfusion with RBC suspension from whole blood, treated with riboflavin and ultraviolet pathogen reduction technology
15929086|NCT03426553|Biological|irradiated RBC|35 patients who met all inclusion and exclusion criteria received transfusion with irradiated RBC suspension
15929087|NCT03426540|Drug|Conbercept|Three-port 25-G PPV was performed in all patients using a Constellation system. Patients in the treatment group received an intravitreal injection of conbercept (10 mg/mL, 0.5 mg) using a sterile technique after 25-G vitrectomy.
15929088|NCT03426527|Drug|Levobupivacaine|Following induction of anaesthesia, patients will receive ultrasound guided bilateral superficial cervical plexus block with levobupivacaine
15929089|NCT03426527|Drug|Levobupivacaine-Dexmedetomidine|Following induction of anaesthesia, patients will receive ultrasound guided bilateral superficial cervical plexus block with levobupivacaine in conjunction with dexmedetomidine
15929090|NCT03426527|Other|General Anaesthesia|Using propofol, fentanyl and atracurium
15929091|NCT03426514|Procedure|Three-port Laparoscopic Surgery|Patients undergo three-port laparoscopic surgery. The surgery will be completed by a surgeon and a camera-person without another assistant. The surgeon will adjust surgical position to expose the operative field with the help of gravity. All the orther operative procedures are the same as conventional laparoscopic surgery.
15929092|NCT03426514|Procedure|Conventional Laparoscopic Surgery|Patients undergo conventional laparoscopic surgery（4 or more ports）.The surgery will be routinely completed by a surgeon，a camera-person and another assistant to provide counter-traction.
15929093|NCT03426488|Behavioral|VIP - Västerbotten Intervention Programme|Intervention on CVD (cardiovascular disease) and diabetes
15929094|NCT03426475|Procedure|interprof ACT measures|Definition of common goals between general practitioner and nursing staff, appointment of a contact person, support in assigning medication, use of name badges worn by GPs and nurses during visits, mandatory availability of contact person, standardized procedures for GPs home visits
15929095|NCT03426462|Drug|Propofol|Induction of anesthesia and two further deepening episodes will be performed whilst recording the electroencephalogram.
15929096|NCT03426449|Procedure|posterolateral sphincterotomy|Fissurectomy and limited division of internal anal sphincter at 5 o'clock position for 8-10 mm
15929097|NCT03426449|Procedure|lateral sphincterotomy|Fissurectomy and limited division of internal anal sphincter at 3 o'clock position for 8-10 mm
15929098|NCT03426436|Diagnostic Test|Two consecutive 15-lead ECGs|The 15-lead ECG consists of a traditional 12-lead ECG and an additional three leads on the right side of the body. The first 15-lead ECG will have an additional three electrodes/stickers on the right side of the chest and the second 15-lead ECG will have an additional three electrodes/stickers on the posterior side.
15929099|NCT03426423|Other|Behavioral smoking cessation intervention|"The intervention consists in a behavioral smoking cessation intervention combined with pharmacotherapy. The intervention is tailored it to specificities of participants based on findings from the previous phase of our study (DISCGO-MIX, Swissethics ID PB_2016-01459).
~Counseling will cover topics such as assessing ambivalence and enhancing motivation with motivational interviewing methods, identifying barriers to quit, coping with cravings and intensive relapse prevention strategies. Participants will be advised to use over the counter nicotine replacement bi-therapy (NTR). A 2-week starting kit, consisting of nicotine transdermal patch and a short acting NRT (lozenge, gums, inhaler or mouth spray) will be provided to participants for free, if they wish to take NRT.
~The behavioral intervention will last 30-45 minutes, and will be conducted by a research nurse using an interview guide."
15929191|NCT03425669|Device|Sham stimulation|Patients will receive sham stimulation in place of active vestibular stimulation.
15929192|NCT03425669|Drug|Active medication|Patients will be examined with and without medication.
15961182|NCT03179852|Behavioral|nutrition education|nutrition education
15929100|NCT03426423|Other|Control|"Participants assigned to the control group will receive a less intensive and non-tailored intervention for smoking cessation.
~For this arm the structured 3 steps AAR approach will be used:
~Ask for smoking status. Advise to quit in a clear manner. Refer to external help: participants will receive a booklet with information on smoking cessation (non specific to diabetes and gender) and links to support facilities (national quitline, smoking cessation clinic, websites, self-help).
~This unique intervention of 5-10 minutes will be performed by the research nurse."
15929101|NCT03426410|Other|Survey|Electronic survey containing a questionnaire regarding knowledge and use of national guidelines of low back pain rehabilitation, type and frequency of cross sectional communication, attitudes and beliefs about back pain and two patient vignettes.
15929102|NCT03426384|Behavioral|Mymee Program|A combination of digital therapeutics and telephonic health coaching is used to identify and test dietary, lifestyle, and environmental triggers in order to reduce symptoms of auto-immune disease.
15929103|NCT03426371|Drug|KL-140|"KL-140 will be administered every 7 days at an initial dose of 400 milligram per square meter (mg/m^2) at 5 milligram per minute (mg/min) and 250 mg/m^2 at 10 mg/min for subsequent infusions until progression of disease, withdrawal of consent, or unacceptable toxicity to KL-140.
~Drug: Oxaliplatin Oxaliplatin 85 mg/m^2 infusion over 120 minutes on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity.
~Drug: Folinic Acid FA 200 mg/m^2 infusion over 120 minutes on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity.
~Drug: 5Fluorouracil 5-FU as a bolus of 400 mg/m^2/day intravenously followed by 2400 mg/m^2/day infusion over 48 hours on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity."
15929104|NCT03426371|Drug|Placebo|"Placebo will be administered every 7 days at an initial dose of 400 milligram per square meter (mg/m^2) at 5 milligram per minute (mg/min) and 250 mg/m^2 at 10 mg/min for subsequent infusions until progression of disease, withdrawal of consent, or unacceptable toxicity Drug: Oxaliplatin Oxaliplatin 85 mg/m^2 infusion over 120 minutes on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity.
~Drug: Folinic Acid FA 200 mg/m^2 infusion over 120 minutes on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity.
~Drug: 5Fluorouracil 5-FU as a bolus of 400 mg/m^2/day intravenously followed by 2400 mg/m^2/day infusion over 48 hours on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity."
15929105|NCT03426358|Device|LSM assessed by Elastographic Techniques|Performing Transient Elastography, ARFI or 2D-SWE on patients at baseline (within 1 month before HSCT) and after HSCT on days +9/10, +15/17, +22/24
15929106|NCT03426345|Drug|Placebo|Placebo injected subcutaneously twice daily.
15929107|NCT03426345|Drug|Relamorelin|Relamorelin 10 μg injected twice daily for 12 weeks.
15929108|NCT03426332|Other|No intervention|No intervention
15929109|NCT03426319|Diagnostic Test|Cardiovascular evaluation|Cardiovascular evaluation includes anamnesis, physical examination, laboratory tests, analysis of endothelial function, 24h blood pressure profile, Holter ECG, echocardiography and cardiac MRI.
15929110|NCT03426306|Diagnostic Test|4DCT-Ventilation|4DCT-ventilation is an imaging modality that provides superior image quality, reduced cost, and a faster imaging procedure compared to nuclear medicine VQ scans.
15929111|NCT03426293|Other|Measuring the ACT to determine effect of heparin|Measuring the ACT to determine effect of heparin during non-cardiac arterial procedures
15929112|NCT03426280|Device|Apple Watch Series 1|Clinic pharmacists will issue Apple Watches to study arm patients and teach them the usage of the Activity app. In addition to usual care, these patients will each receive an in-person 3-minute coaching session during clinic visit at 2, 4, 6 and 12 months.
15929113|NCT03426267|Drug|SDN-037|twice daily
15929114|NCT03426267|Drug|Placebo|twice daily
15929117|NCT03426241|Other|no intervention|this is cross-sectional study
15929118|NCT03426228|Diagnostic Test|HbA1C|"After overnight fasting, 10 ml of blood will be collected at four different timings during the IVF protocol:
~At baseline (second day of the menstrual period)
~Triggering phase (post-egg retrieval procedure)
~Embryo transfer phase (post-transfer procedure)
~Week 4 (positive bHCG)
~4. Week 8 of pregnancy"
15929119|NCT03426215|Diagnostic Test|Magnetic Resonance Imaging (MRI)|Changes in size and severity of the main herniated disc causing radiating pain will be evaluated by radiology specialists and Korean medicine doctors (KMDs) and categorized into three groups (improved, worse or no discernible change) in comparison with the immediate previous MRI to track long-term changes and assess for correlations in subjective clinical symptoms and objective physical evaluation and MRI results.
15929120|NCT03426202|Drug|Modafinil Oral Tablet|modafinil 200mg
15929121|NCT03426202|Drug|Placebo Oral Tablet|placebo 200mg
15929122|NCT03426189|Procedure|Leukapheresis|Blood will be taken by a needle inserted into a vein in one arm and processed through a machine, which spins the blood so that the white blood cells will be separated out of the machine for purposes of this research. The rest of the blood will be returned through a needle in the other arm.
15929123|NCT03426189|Procedure|Lymph node biopsy|Ultrasound will be used to localize the position of one lymph node in the groin. Under a light general anesthetic, one lymph node will be removed.
15929124|NCT03426176|Drug|oxytocin nasal spray|intranasal administration of oxytocin (24 IU)
15929125|NCT03426176|Drug|intranasal placebo treatment (placebo-control for oxytocin)|intranasal administration of placebo nasal spray
15929126|NCT03426176|Drug|ATD treatment|oral administration of ATD (75.2g) (Acute Tryptophan Depletion)
15929127|NCT03426176|Drug|oral placebo treatment (placebo-control for ATD)|oral administration of a tryptophan-balanced mixture (78.2g)
15929128|NCT03426163|Device|Virtual reality|Application of knee MRI transformed virtual reality system
15929129|NCT03426150|Drug|CPP-ACP|The surfaces of specimens were pretreated with CPP-ACP for 3 min
15929130|NCT03426150|Drug|Placebos|The surfaces of specimens were pretreated with deionized water for 3 min
15929131|NCT03426137|Drug|Oxycodone|5mg Oxycodone in oral solution given every 3 hours
15961250|NCT03179345|Other|Placebo|
15929132|NCT03426137|Drug|Ketorolac|toradol intravenous (IV) 30mg. Maintain toradol IV every 8 hours, round the clock. For patients with renal insufficiency, decrease toradol dose to 15mg every 8 hours. For patients over 65 years old, decrease toradol dose to 15 mg every 8 hours. After 24 hours, start oral NSAIDS every 8 hours round the clock when tolerating pain.
15929133|NCT03426137|Other|Placebo|Oral solutions containing only the carrier vehicle - a flavored syrup called OraSweet
15929134|NCT03426124|Device|EkoSonic Endovascular System with thrombolytic|The device uses ultrasonic waves in combination with clot-dissolving thrombolytic drug to effectively dissolve clots.
15929135|NCT03426111|Device|Endoscopic Gastric Tubulization with OverStitch® system (Apollo Endosurgery, Austin, TX, USA)|This endoscopic technique is defined as a gastric restriction by means of sutures of the entire gastric wall, transmurally, in order to simulate a gastric sleeve, in the same way as sleeve gastrectomy surgery. Gastroplasty is performed using an endoscopic suture system (OverStitch, Apollo Endosurgery Inc., Austin, Texas, USA) inserted into a dual-channel endoscope (GIF-2T160, Olympus Medical Systems Corp., Tokyo, Japan).
15929136|NCT03426111|Behavioral|Lifestyle modification|Hypocaloric diet and moderate physical exercise
15929137|NCT03426098|Device|Secret RF|A series of 3 facial treatments with the Secret Micro-Needle Fractional RF System® at 4 week intervals.
15929138|NCT03426085|Drug|Liraglutide 6 mg Solution for Injection|
15929139|NCT03426085|Other|Placebo|
15929140|NCT03426072|Other|modified IHI breakthrough series|"There are five main elements to the intervention:
~Establishment of the team and set up
~Establishing baseline performance and knowledge
~Ongoing developmental support
~Learning sessions (3)
~Action periods (3)
~The actual facilitative actions (e.g., coaching, guiding, mentoring, supporting) occur in combination with limited teaching, largely during telephone conferences but also in any visit, which may occur up to quarterly.
~5. The concluding session is an opportunity for networking, sharing successes and making plans for the continuation of project work following the end of formal support"
15929141|NCT03426059|Other|No Intervention|No Intervention. This is an observational study.
15929142|NCT03426046|Procedure|Partial Pulpotomy|Partial removal of inflamed pulp tissue in cariously exposed teeth
15929143|NCT03426046|Drug|Pulp Capping Agents|Biocompatible materials
15929144|NCT03426033|Drug|ISIS 681257|Xmg dose administered as a subcutaneous injection
15929145|NCT03426033|Drug|Warfarin|25mg tablet administered orally
15929146|NCT03426020|Other|Oral midazolam|0.5 mg/kg oral midazolam administered 20 minutes before induction
15929147|NCT03426020|Other|Film http://www.animaturk.com/animasyon/suko-ameliyat-oluyor|patients will be watched a short movie (at URL: http://www.animaturk.com/animasyon/suko-ameliyat-oluyor ) 20 minutes before induction.
15929148|NCT03426020|Other|Play game (PC fishing game)|Patients will be played a simple PC game (a fishing game) 20 minutes before induction
15929149|NCT03426007|Procedure|Uterine lavage|embryo recovery from the uterus following either natural cycle (NC)/intrauterine insemination (IUI), or controlled ovarian hyperstimulation (COH)/intrauterine insemination (IUI).
15929150|NCT03425994|Drug|Elvitegravir/Cobicistat/Emtricitabine|Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide 150mg/150mg/200mg/10mg (Genvoya) film coated tablet
15929151|NCT03425981|Other|Whole-Body Electromyostimulation Training|"The WB-EMS training program consisted of six WB-EMS training sessions (one per week) and six running training sessions (also one per week).
~This intervention programme followed a within-day undulating periodization model. The training sessions were divided into four parts: warm up (A), strength (B), high intensity interval power training (c), and high intensity interval training (HIIT) (D)."
15929152|NCT03425955|Device|SUNEKOS ® 200|"4 micro-injection sessions of SUNEKOS® 200 with an interval of 10 days. Two different injection techniques were carried out mono-laterally on the left or right face side randomly: interstitial fluid technique (IFT) on one face side; bolus technique on five pre-determined face points (zygomatic protuberance, nostril's angle, inferior margin of tragus, lip marionette lines, mandibular angle) on the contralateral face side."
15929153|NCT03425955|Device|"SUNEKOS® 1200 and SUNEKOS® 200"|"5 micro-injection sessions (one of the product SUNEKOS® 1200 and four of SUNEKOS® 200. SUNEKOS® 1200 was injected bi-laterally on the face with cushion technique. 24 hours after the SUNEKOS® 1200 treatment, 4 micro-injection sessions of SUNEKOS® 200 with an interval of 10 days were performed . SUNEKOS® 200 was injected with two different techniques, carried out mono-laterally on the left or right face side randomly: retrograde interstitial fluid technique (RIFT) on one face side; bolus technique on five pre-determined face points (zygomatic protuberance, nostril's angle, inferior margin of tragus, lip marionette lines, mandibular angle) on the contralateral face side."
15929154|NCT03425942|Behavioral|Internet Cognitive Behavioral Therapy for insomnia (ICBT-i)|This intervention lasts for five weeks. The intervention is internet-based and mainly consists of the most potent CBT technics i.e. sleep restriction and stimulus control. Weekly feedback is provided by master students supervised by clinical psychologists.
15929155|NCT03425942|Behavioral|Internet Applied Relaxation Techniques (IART-i)|This intervention lasts for five weeks. The intervention is internet-based and consists of different common applied relaxation exercises and treatments. Weekly feedback is provided by master students supervised by clinical psychologists.
15929156|NCT03425929|Drug|Oxytocin|Intranasal administration, 24 international units (IU) oxytocin.
15929157|NCT03425929|Drug|Placebo|The placebo nasal sprays contain identical ingredients except for the peptide itself.
15929158|NCT03425916|Other|Physical therapy intervention|Primiparous women start a physical therapy intervention in week 6 after normal one-child delivery, based on abdominal and pelvic floor exercises, education and behavior advices. Abdominal muscle condition and activation are measured by transabdominal ultrasound and surface electromiography. This group is going to be examined after treatment and 6 and 12 months after treatment.
15929159|NCT03425903|Device|Whole body cryotherapy sessions|Whole body cryotherapy (WBC) 10 sessions of 3 minutes at a temperature of -196ºC (point of evaporation of liquid nitrogen), on the basis of three sessions a week.Fills in questionnaires.
15929160|NCT03425890|Behavioral|SURE program|SURE program is a self-exercise program which aims to empower people with stroke and their caregivers to increase early UL practice outside therapy
15929242|NCT03425331|Drug|Ipilimumab|Ipilimumab is a type of immunotherapy. Immunotherapy works by stimulating the body's own immune system to attack cancer cells
15929361|NCT03424356|Procedure|cystoscopy|patients will treated with this surgical procedure
15929161|NCT03425877|Device|MS Band 2|Before starting the experiments, the subjects will be helped to wear the Microsoft® Band 2 bracelet (a smartwatch capable of recording data from over 12 sensors, including a heart rate sensor and a skin conductance sensor) and a session will be recorded Of 10 minutes at rest. After the rest period and always wearing the Microsoft® Band 2, the subjects will perform the other session of the procedure.
15929162|NCT03425877|Behavioral|Emotion Assessment|The subjects will be subjected to the viewing of 21 video clips depicting 6 different emotional states belonging to the FilmStim database validated by Schaefer's studio and collaborators (Schaefer, Nils, Sanchez, & Philippot, 2010). When viewing the clip, subjects will wear the Microsoft ® Band 2 .and after each movie clip of an evaluation of the stimulus value and activation level perceived by the Self-Assessment Manikin (Bradley & Lang, 1994) questionnaire). The presentation of movie clip is randomized and does not follow a fixed effect. Between the presentation of each clip a fixed interval of 15 seconds has been inserted in order to induce artifacts and overlap of physiological signals among different emotional valence video clips.
15929163|NCT03425877|Behavioral|Single Task|The section includes three tasks which involve upper and lower extremities, and cognitive functions, associated with low cognitive and motor load for their execution. Subjects are required to perform a single task, i.e. without the simultaneous execution of other tasks. Grasping(Motor Upper Limbs): The subject is required to reach an object's dominant limb and grab it. Walking(Motor Lower Limbs): It is required to carry 10 feet of walk. Attention(Cognitive): Signal detection task. The subject is required to detect acute sound between a series of serious sounds (Oddball Paradigm).
15929164|NCT03425877|Behavioral|Dual Task|This section includes three tasks of different types (upper limb motor, lower limb motor, cognitive) that will be performed with a greater cognitive load. Elbow N-back (Dual Task Motor upper limbs): The subject is required to reconfigure the arrangement of the floppy disks on a different blade, by moving only one disk at a time and by putting a disk on another bigger disk, never on a smaller one. Walking + Nback (Dual Task Motor lower limbs): The subject is required to walk while subtracting from 100 to 3 in 3. Problem Solving (Dual Task Cognitive): The subject is subjected to a deductive logic puzzle.
15929165|NCT03425877|Behavioral|Rest|At this stage, the HR and GSR signals will be recorded during a period of rest of 10 minutes. The subjects wear a pair of headphone for reducing the environmental sound noise. Through the headphones a sound indicates to the subject when recording starts and stops. Two separate recording of 5 minutes are performed, the first is performed while keeping eyes closed The two session are presented randomly to each different subject in order to prevent a bias due to order effect .
15929166|NCT03425864|Procedure|connective tissue graft|patient will receive immediate implant and connective tissue graft
15929167|NCT03425864|Device|immediate implant|patient will receive immediate implant with connective tissue graft.
15929168|NCT03425851|Other|Diapers|Receive 600 diapers.
15929169|NCT03425851|Other|Resources of diaper banks|Caregivers will receive resources of diaper banks.
15929170|NCT03425838|Drug|CDK 4/6 inhibitor|Adding CDK 4/6 inhibitor (pabociclib, ribociclib or abemaciclib depending on availability and physician's preference) to either first line treatment (with non-steroidal aromatase inhibitors, either letrozole or anastrozole) or second line treatment (with fulvestrant) in advanced HR+/HER2-negative breast cancer
15929171|NCT03425838|Drug|Non-Steroidal Aromatase Inhibitor|Adding CDK 4/6 inhibitor (pabociclib, ribociclib or abemaciclib depending on availability and physician's preference) to either first line treatment (with non-steroidal aromatase inhibitors, either letrozole or anastrozole) or second line treatment (with fulvestrant) in advanced HR+/HER2-negative breast cancer
15929172|NCT03425838|Drug|Fulvestrant|Adding CDK 4/6 inhibitor (pabociclib, ribociclib or abemaciclib depending on availability and physician's preference) to either first line treatment (with non-steroidal aromatase inhibitors, either letrozole or anastrozole) or second line treatment (with fulvestrant) in advanced HR+/HER2-negative breast cancer
15929173|NCT03425825|Other|Non-interventional|Non-interventional
15929174|NCT03425812|Drug|To withdraw NSAIDs therapy|NSAIDs therapy will be withdrew after washout period.
15929175|NCT03425812|Drug|To continue NSAIDs therapy|NSAIDs therapy will be continued.
15929176|NCT03425799|Drug|Sodium Chloride 0.9% Inj|Inactive ingredient mixture for injection without drug, intravenous infusion bags containing normal saline, manufactured and provided by Exela Pharma Sciences, LLC from a single batch / lot.
15929177|NCT03425799|Drug|Tranexamic Acid|Tranexamic Acid Intravenous Infusion Bags (10 mg/mL), manufactured and provided by Exela Pharma Sciences, LLC from a single batch / lot.
15929178|NCT03425786|Behavioral|Diagnostic training|Training in the Dix-Hallpike maneuver and the supine head roll test to diagnose BPPV.
15929179|NCT03425786|Behavioral|Diagnostic and treatment training|Training in the Dix-Hallpike maneuver and the supine head roll test to diagnose BPPV. Training in the Epley and Barbecue maneuvers to treat BPPV.
15929180|NCT03425773|Biological|BVAC-B|Autologous B cell and monocyte presenting HER2/neu antigen
15929181|NCT03425747|Drug|Calcium Carbonate|subjects will be assigned to a calcium supplement (Carbonate or Citrate) at the same total amount of elemental calcium that they had taken before the study enrolment.
15929182|NCT03425747|Drug|Calcium Citrate|subjects will be assigned to a calcium supplement (Carbonate or Citrate) at the same total amount of elemental calcium that they had taken before the study enrolment.
15929183|NCT03425734|Drug|Dexmedetomidine|The drug will be prepared in 50 ml saline 0.5 ml DEX (100mc/ml +49.5 cc saline 1ml=1mg), and the dose will be calculated according to body weight.
15929184|NCT03425721|Other|No Intervention|No Intervention is administered in this study.
15929185|NCT03425708|Drug|20mg Febuxostat|Participants take 20mg febuxostat pill once a day for at least six months.
15929186|NCT03425708|Drug|40mg Febuxostat|Participants take 40mg febuxostat pill once a day for at least six months.
15929187|NCT03425695|Device|CheseeTM Diode Laser|low level laser therapy was utilized adjunct with free gingival graft.
15929188|NCT03425695|Other|Clinical examination|"The shrinkage of the graft area was calculated according to the differences between the graft area at baseline, 1st, 3rd, and 6th months.
~Epithelization was determined via bubbling test by using 3% hydrogen peroxide (H2O2) at 7, 14, 21, and 28 days after surgery."
15929189|NCT03425682|Other|ViBone|Viable Bone Allograft
15929243|NCT03425331|Drug|Nivolumab|Nivolumab is a type of immunotherapy. Immunotherapy works by stimulating the body's own immune system to attack cancer cells
15929193|NCT03425656|Drug|Trastuzumab plus docetaxel (for four 21-day cycles) after four 14-day cycles of Doxorubicin plus cyclophosphamide|Trastuzumab (8 mg/kg IV loading dose at cycle 1, followed by 6 mg/kg at subsequent cycles) is given concomitantly with docetaxel (100 mg/m2 IV) for four 21-day cycles after four 14-day cycles of Doxorubicin (60 mg/m2 IV) plus cyclophosphamide (600 mg/m2 IV)
15929199|NCT03425630|Dietary Supplement|Argicolina|8 weeks
15929200|NCT03425630|Dietary Supplement|Normolip|8 weeks
15929201|NCT03425617|Drug|Tiotropium + Olodaterol|tiotropium 5 mcg plus olodaterol 5 mcg via Respimat® single dose
15929202|NCT03425617|Other|PLACEBO|PLACEBO via Respimat® single dose
15929203|NCT03425604|Procedure|Intrauterine insemination|
15929204|NCT03425591|Drug|Ibrutinib|Participants in this observational study with confirmed diagnosis of CLL and MCL receiving ibrutinib in routine clinical practice settings will be observed for 5 years.
15929205|NCT03425578|Dietary Supplement|MSG|150 mg/kg body mass monosodium glutamate (MSG).
15929206|NCT03425578|Dietary Supplement|CHO|75g CHO (i.e. dextrose)
15929207|NCT03425578|Dietary Supplement|Placebo A|A non-caloric placebo composed of table salt (NaCl) and sucralose (Splenda).
15929208|NCT03425578|Dietary Supplement|Placebo B|A non-caloric placebo composed of flavoured water.
15929210|NCT03425552|Drug|Paliperidone|Paliperidone Palmitate extended-release injectable suspension 156 mg (100 mg of Paliperidone)
15929211|NCT03425552|Drug|Paliperidone|Paliperidone Palmitate 156 mg (equivalent to Paliperiodne 100 mg) extended release injectable suspension
15929214|NCT03425526|Biological|Allogeneic Adenovirus-specific Cytotoxic T Lymphocytes|Given IV
15929215|NCT03425513|Diagnostic Test|Hepatitis B serology|A serum specimen will be taken and assessed for hepatitis B serology (HBsAg and anti-HBc antibodies).
15929216|NCT03425513|Other|Questionnaire|Participants will be asked to fill in a questionnaire regarding demographic characteristics, known viral hepatitis status and risk factors for HBV infection.
15929217|NCT03425500|Procedure|Bridging Rotator Cuff Reconstruction|Bridging Rotator Cuff Reconstruction of massive rotator cuff tear using a GRAFTJACKET™ allograft
15929218|NCT03425500|Procedure|Superior Capsular Reconstruction|Superior Capsular Reconstruction of massive rotator cuff tear
15929219|NCT03425500|Device|GRAFTJACKET™ allograft|The acellular human dermal allograft in used in the bridging rotator cuff reconstruction
15929220|NCT03425487|Behavioral|Mindfulness based Intervention|MBSR consists of 8 weekly groupal sessions of 150 minutes/session (10-16 people). Written material and sound recordings will be offered as support elements. The estimated duration of the program is two months
15929221|NCT03425487|Behavioral|Compassion based Intervention|ABCT consists of 8 weekly groupal sessions of 120 minutes/session (10-16 people). Written material and sound recordings will be offered as support elements. The estimated duration of the program is two months.
15929222|NCT03425487|Other|TAU|Usual specialized treatment in mental health (psychological or/and psychiatric)
15929223|NCT03425474|Drug|Remimazolam Tosilate|Initial dose plus supplemental doses as necessary
15929224|NCT03425474|Drug|Propofol|Initial dose plus supplemental doses as necessary
15929225|NCT03425461|Biological|Anti-SEMA4D Monoclonal Antibody VX15/2503|Given IV
15929226|NCT03425461|Biological|Ipilimumab|Given IV
15929227|NCT03425461|Other|Laboratory Biomarker Analysis|Correlative studies
15929228|NCT03425461|Biological|Nivolumab|Given IV
15929229|NCT03425461|Other|Pharmacological Study|Correlative studies
15929230|NCT03425448|Drug|Heparin|Heparin hemodialysis catheter lock solution
15929231|NCT03425448|Device|Neutrolin|Neutrolin hemodialysis catheter lock
15929232|NCT03425435|Other|QoL and developed questionnaires for healthcare research|Questionnaires
15929233|NCT03425422|Device|VITARIA System|Chronic stimulation of the right cervical vagus nerve
15929234|NCT03425409|Device|Integra Pulse Portable- Continuous flow|4 liters per minute oxygen flow
15929235|NCT03425409|Device|Integra Pulse Portable- Pneumatic pulsed flow|Oxygen flow determined by test device
15929236|NCT03425396|Drug|Omadacycline tablets|Oral Omadacycline
15929237|NCT03425396|Drug|Nitrofurantoin capsules|Oral Nitrofurantoin
15929238|NCT03425383|Diagnostic Test|FMD and c-IMT|"The diameter of the target artery (right brachial artery) will be measured from two- dimensional ultrasound images, with a 70 MHz linear array transducer and a standard 128XP/10 system (Acuson, Mountain View, California, USA).
~c-IMT will be assessed by M-mode ultrasonography via a vivid 7 MHz linear array transducer and a standard 128XP/10 system (Acuson, Mountain View, California, USA) with participants in the supine position."
15929239|NCT03425370|Procedure|Closure of surgical wounds using buried sutures or tissue adhesive on aesthetic outcome.|Effect of replacing buried sutures with tissue adhesive on aesthetic outcome of surgical wounds will be measured using the POSAS.
15929240|NCT03425357|Other|Low Load Exercises|"All rotator cuff and scapular exercises are performed with 3 sets of 20 repetitions 3 times per week for 12 weeks. The load is set at around 60% of 1 RM (20 reps).
~The glenohumeral/postural corrective exercises are performed with 3 sets of 5 repetitions (The position is held for 15 seconds per repetition)."
15929241|NCT03425344|Diagnostic Test|Diagnostic|No traditionally intervention will be given but participants will be exposed to shoulder- MRI, ultrasound and sonoelastography..
15929244|NCT03425318|Device|CNAP|Application of CNAP in patients with ARDS
15929246|NCT03425292|Radiation|conformal brain radiation therapy|standard radiation therapy for newly diagnosed glioblastoma
15929247|NCT03425292|Drug|Nivolumab|nivolumab 300 mg IV every 2 weeks
15929248|NCT03425292|Drug|Ipilimumab|ipilimumab 1 mg/kg IV every 6 weeks
15929249|NCT03425292|Drug|Bevacizumab|bevacizumab 5 mg/kg IV every 2 weeks
15929250|NCT03425292|Drug|Metronomic Temozolomide|50 mg/m^2 oral, once daily
15929251|NCT03425292|Drug|5-day Temozolomide|100 mg/m^2 oral, once daily on Days 2-6 of each 6 week course
15929252|NCT03425292|Drug|Lomustine|100 mg/m^2 oral, on Day 1 of each 6 week course
15929253|NCT03425279|Biological|CAB-AXL-ADC|Conditionally active biologic anti-AXL antibody drug conjugate
15929254|NCT03425279|Biological|PD-1 inhibitor|PD-1 inhibitor
15929255|NCT03425266|Other|Interactive decision support tool|PainApp 1) assesses patient treatment goals (a structured values clarification exercise) and preferences, including decision making and communication preferences; 2) presents structured educational modules tailored to the user's stated goals and preferences; 3) presents educational information addressing identified gaps in care and communication; 4) assesses pain, pain interference, function, and other clinical factors; 5) generates succinct individualized summaries of patient treatment preferences and medical history, tailored to different clinical settings; 6) generates a personalized report for the patient, based on their goals and interests; 7) transmits the clinical summary to the patient and their provider(s), with patient permission.
15929256|NCT03425253|Drug|BELKYRA®|BELKYRA® was injected into preplatysma fat tissue in the submental area (at least 1 plus up to 5 optional treatments, for maximum of 6 treatments 8 weeks apart).
15929257|NCT03425253|Device|Juvéderm® VOLUMA™ with Lidocaine|Juvéderm® VOLUMA™ with Lidocaine VOLUMA™ was injected along the mandibular border.
15929258|NCT03425240|Device|Nerve Stimulation|Acute placement of electrodes on the pelvic plexus to apply electrostimulation during open radical prostatectomy.
15929259|NCT03425227|Other|FRED EXERGAME|biofeedback with physiological constants as follows: systolic blood pressure, diastolic blood pressure, heart rate and blood oxygen saturation
15929260|NCT03425214|Other|fMRI|"Session will be of about 45 minutes. The reward system will be explore using an experimental task during functional Magnetic Resonance Imaging (fMRI). The name of this task is themonetary incentive delay task."
15929261|NCT03425214|Other|Videopolysomnography|Video polysomnography will be perform in the sleep center during one night if patient did not have vPSG for 1 year.
15929262|NCT03425214|Other|NC (narcolepsy-cataplexy)|The investigators hypothesize that NC patients with RBD have a more severe dysfunction of the reward system (hypoactivation of the meso-cortico-limbic pathway) than patients without RBD.
15929263|NCT03425201|Drug|Niraparib plus Cabozantinib|Non-randomized trial will comprise 2 stages. A dose escalation phase will characterize the safety, tolerability, DLTs and MTD, of oral niraparib plus cabozantinib in patients with urothelial or renal cell carcinoma. Subsequently, the phase II will further evaluate the safety and antitumor activity of this combination in patients with urothelial carcinoma.
15929264|NCT03425175|Other|Audio-recoring|Recording of audio through microphone carried bu surgeon and assistant surgeon
15929265|NCT03425162|Drug|Morphine Sulfate|patient-controlled analgesia (PCA) morphine
15929266|NCT03425162|Procedure|Group P|Group P:patient-controlled analgesia (PCA) morphine
15929267|NCT03425162|Procedure|Group A|Group A:Ultrasound guided unilateral anterior Quadratus Lumborum block with 20 ml %0.25 Bupivacaine
15929268|NCT03425149|Biological|VLA1601|purified inactivated ZIKV vaccine candidate adsorbed on alum
15929269|NCT03425149|Biological|Placebo|Phosphate buffered saline (PBS)
15929270|NCT03425136|Other|Systems Analysis and Improvement Approach (SAIA)|Five-step systems analysis and iterative improvement cycles applied by district maternal and child health supervisors to subordinate health facilities providing prevention of mother-to-child HIV transmission services at the facility level.
15929271|NCT03425123|Other|Regenerative Endodontic Procedure (REP)|Regenerative Endodontic Procedure (REP) involves disinfection of the root canal with the use of acombination of three antibiotics including ciprofloxacin, metronidazole, minocycline. At the second visit, the patient is evaluated for resolution of signs or symptoms of an acute infection and if none then bleeding is induced, the site covered with a plug and the patient is evaluated at follow up.
15929272|NCT03425110|Other|Modified Ketogenic Diet|
15929273|NCT03425097|Drug|Fexofenadine|Fexofenadine 180 mg in the morning
15929274|NCT03425097|Drug|Placebo - Cap|Placebo cap in the morning
15929275|NCT03425084|Drug|Morphine|The study was designed as an open, non-controlled drug trial, with scientists and participants blinded to the patients OCT1 status. Morphine will be given as a single dosis (0,15 mg/kg) at the end of the Surgery and later as boluses of 0,04mg/kg administrated by patient-controlled analgesia, (PCA). Blood samples with drug concentrations will be used to determine a difference in morphine AUC due to the patients OCT1 status. Questionnaire answers will be used to determine the effect of morphine due to the patients OCT1 status
15929276|NCT03425045|Procedure|Repetitive Transcranial Magnetic Stimulation|Patients randomised in Arm 1 will receive stimulation of the dorsolateral prefrontal cortex (frequency 25 Hz; 300 pulses; 80% resting motor threshold=RMT) and primary auditory cortex on both sides (1 Hz; 1000 pulses; 110% RMT) will be stimulated in patients in rTMS stimulation group for 5 consecutive days. No medication therapy will be provided for patients in this arm.
15929277|NCT03425045|Procedure|Sham stimulation|Sham stimulation will be performed in patients randomised in Arm 2 of the study for 5 consecutive days. No medication therapy will be provided for patients in this arm.
15929278|NCT03425045|Drug|Ginkgo Biloba Extract|Patients randomised in Arm 3 of the study will receive medication therapy with Ginkgo biloba extract EGb 761 once a day for 6 months.
15929279|NCT03425032|Device|CT scanner|Regular CT imaging of the abdomen and pelvis
15929280|NCT03425019|Device|Soterix 1x1 tDCS mini-CT Stimulator device|Transcranial Direct Current Stimulation (tDCS) involves the application of weak direct electric current to the head in a noninvasive and painless manner. tDCS with a constant current intensity of 2 mA will be applied for 20 minutes per session daily for 2 weeks (Monday to Friday) via the Soterix 1x1 tDCS mini-CT Stimulator device. Participants will self-administer tDCS at their home or a private room for two weeks (Mondays-Fridays) under real-time supervision by the research staff.
15929281|NCT03425006|Drug|Itacitinib|a JAK 1 selective small molecule inhibitor
15961762|NCT03175289|Other|Quality-of-Life Assessment|Ancillary studies
15929283|NCT03424993|Other|Dietary Sodium Restriction|A registered dietician will counsel participants to reduce daily habitual dietary salt intake below 2000mg over 4 weeks
15929284|NCT03424993|Other|Control|Participants will consume their routine habitual dietary sodium intake > 3400mg per day with regular pre determined check in phone calls from a registered dietician.
15929285|NCT03424980|Combination Product|Tyrosine kinase inhibitors|Tyrosine kinase inhibitors only or combinations therapies of tyrosine kinase inhibitors
15929286|NCT03424967|Behavioral|ABM|Participants are trained with a dot-probe task including angry-neutral faces. In 80% of trials the probe appears in place of the neutral face, and in 20% of trials in place of the angry face.
15929287|NCT03424954|Behavioral|EpxOstomy|A 30-day post-operative automated text-messaging intervention for home monitoring of ileostomy output
15929288|NCT03424941|Device|FFR-guided PCI and TAVI|Treatment of subjects with multivessel coronary artery disease and aortic stenosis for FFR-guided PCI and TAVI (Medtronic CoreValve Evolut R or Medtronic CoreValve Evolut R PRO)
15929289|NCT03424941|Device|CABG and SAVR|Treatment of subjects with multivessel coronary artery disease and aortic stenosis for CABG and SAVR
15929290|NCT03424928|Drug|Pomalidomide 4 MG Oral Capsule|per os,capsule,4mg,1 capsule per period
15929291|NCT03424928|Drug|Pomalidomide 4 MG Oral Capsule-Pomalyst|per os,capsule,4mg,1 capsule per period
15929297|NCT03424902|Diagnostic Test|cardiac computed tomography and cardiac catheterization|assesment of certain predictors with CT and fluroscopy for paravalvular leakage
15929298|NCT03424889|Drug|Xylometazoline|Nasal administration of Xylometazoline
15929299|NCT03424889|Drug|Saline|Nasal administration of 0.9% Saline
15929300|NCT03424876|Drug|Imatinib 400mg|exposure 400 mg/day or 600mg/day,
15929301|NCT03424876|Drug|Sunitinib 37.5Mg Oral Capsule|exposure 37.5 mg/day, continuous taking, or 50 mg/day (4/2)
15929302|NCT03424863|Other|Moderate Intensity Muscle Strengthening|1 session of lower extremity muscle strengthening at moderate intensity (60% of estimated maximal muscle strength). The exercise is performed on one single day.
15929303|NCT03424850|Radiation|HDR brachytherapy|"Dose constraints for 21 Gy:
~Bladder and rectum: V70 < 1 cc
~Urethra: V115 < 1 cc
~V135: 0%
~Dose constraints for 23 Gy:
~Bladder and rectum: V65 < 1 cc
~Urethra: V105 < 1 cc
~V125: 0%
~Dose constraints for 25 Gy:
~Prostate V100 >90% (>95% preferred)
~Bladder and rectum: V70 < 1 cc, Dmax <115%
~Urethra: V110 < 1 cc, Dmax <120%"
15929304|NCT03424837|Behavioral|ASCENT|"ASCENT includes the following components:
~Survivorship care plan created through the ASCENT tool
~Online tool which assesses health care needs and facilitates receipt of care
~A national-level navigator who helps the participant to access support services
~Periodic reminders for the participant to pursue recommended survivorship care"
15929305|NCT03424824|Drug|BP1.3656 low dose|Tablet, once daily oral administration at the low dose
15929306|NCT03424824|Drug|BP1.3656 intermediate dose|Tablet, once daily oral administration at the intermediate dose
15929307|NCT03424824|Drug|Placebo|Tablet, once daily oral administration
15929308|NCT03424811|Device|Mobile Health Intervention|Mobile health intervention to promote healthy eating.
15929309|NCT03424798|Device|Inspiwave|patients are monitored with the Inspiwave device. A low dose inert tracer gas is added to the inspred air
15929310|NCT03424785|Other|drug, stent, surgical treatment|drug, stent, surgical treatment
15929311|NCT03424772|Diagnostic Test|Whole genome sequencing|WGS will be performed for the trio
15929312|NCT03424759|Drug|AZD9291|Patients will be treated 80 mg/day of AZD9291 orally (1 cycle for 21 days).
15929313|NCT03424746|Drug|disodium EDTA|Open-label study of TACT-formula, EDTA-based chelation therapy + commercially available TACT oral multi vitamins, delivering 40-50 infusions over 1 year.
15929314|NCT03424733|Drug|Plegridy|Self injection into area of high adipose content. Injections include 63 and 94 microgram titration doses, and the full 125 microgram dose
15929315|NCT03424733|Drug|Prednisone|Take one 20 milligram prednisone tablet four to five hours prior to injections two through six of the full 125 microgram Plegridy dose.
15929316|NCT03424733|Drug|Tylenol Pill|Take two 325 milligram Tylenol tablets 1 hour prior to each Plegridy injection, irregardless of dosage.
15929317|NCT03424720|Device|PLE and BIS|Investigators attach the PLE and BIS sensors on the forehead of the patients undergoing facial nerve integrity monitoring during general anesthesia using total intravenous anesthetics
15929318|NCT03424707|Drug|DW340(pelubiprofen/eperisone)|DW340
15929319|NCT03424707|Drug|Pelubi(pelubiprofen)|pelubiprofen
15929320|NCT03424707|Drug|Placebo Oral Tablet|Placebo Oral Tablet
15929321|NCT03424694|Radiation|HDR brachytherapy as monotherapy|
15929322|NCT03424681|Drug|Modafinil|Modafinil 300 mg by mouth daily
15929323|NCT03424681|Other|Placebo|Placebo
15929324|NCT03424668|Behavioral|diet|lifestyle factors
15929325|NCT03424655|Procedure|Twisted File Adaptive|Twisted file adaptive SM1 (size 20, .04 taper) and SM2 (size 25, .06 taper) were used serially with a single controlled motion according to the manufacturer's instructions.
15929326|NCT03424655|Procedure|Balance Force|Flex-R files sizes 15-45 taper .02 were used according to the technique
15929327|NCT03424655|Procedure|WaveOne|"WaveOne instrument was used to prepare narrow, straight and curved canals, and file (40.08) was used for large canals.
~Three in-and-out motions were used with lengths not beyond 3 mm in the three thirds of the canal until reaching the estimated WL."
15929328|NCT03424655|Procedure|Reciproc technique|Reciproc files were used in wide canals. Three in-and-out motions were used with lengths not beyond 3 mm in the three thirds of the canal until reaching the estimated WL.
15929329|NCT03424642|Behavioral|Interactive 4D-ultrasound examination|Randomized controlled trial
15929330|NCT03424629|Biological|Low-dose UC-MSCs|Participants will receive 6 times UC-MSCs infusions (each time 1×10^6/kg). The first time to fourth time will be given once a week for successive 4 weeks（week 0,1,2,3）, then the last two times will be given once every two weeks（week 5,7）.
15929331|NCT03424629|Biological|High-dose UC-MSCs|Participants will receive 6 times UC-MSCs infusions (each time 3×10^6/kg). The first time to fourth time will be given once a week for successive 4 weeks（week 0,1,2,3）, then the last two times will be given once every two weeks（week 5,7）.
15929332|NCT03424629|Drug|Methotrexate|Participants will be administered Methotrexate (each time 5-25mg) orally once a week for successive 16 weeks(week 0-15).
15929333|NCT03424616|Device|Suzhou Sceneray® DBS System|We plan to use the SceneRay 1242 (SceneRay, SuZhou, China) electrode with a diameter of 1.27 mm and 4 contacts. The SceneRay 1242 electrode combined with the SceneRay 1181 implantable pulse generator has the advantage of adaptive coverage area for the Ventral Capsule/Ventral Striatum, enabling simultaneous implantation in the nucleus accumbens (NAc; 2 ventral contacts) and the anterior limb of the internal capsule (ALIC; 2 dorsal contacts) with independently programmed parameters such as frequency, amplitude, and voltage; and remote and wireless programing, which allows for convenient and prompt adjustments in emergency situations.
15929334|NCT03424603|Drug|STRO-001|intravenous antibody drug conjugate
15929335|NCT03424590|Device|Clearblue Connected Ovulation Test System|Urinary LH test to predict ovulation
15929336|NCT03424577|Drug|H3B-6527|Oral capsule
15929337|NCT03424564|Drug|Perampanel|Oral Tablet
15929338|NCT03424551|Device|vibrator|Local or whole body vibration was applied at six different frequencies
15929339|NCT03424538|Other|Neurorehabilitation|5-week-long intervention, administered daily, targeted postural instability, balance and mobility using at-limit intensity sensorimotor and visuomotor agility training
15929340|NCT03424538|Other|Physiotherapy|5-week-long intervention, physiotherapy, stretching, walking preparation, strengthening
15929341|NCT03424525|Drug|11C-Trimethoprim|[11C]TMP is a radiolabeled imaging agent for positron emission tomography (PET/CT). Most relevant to this protocol, it is for imaging bacterial infection in human subjects. TMP is well-known, safe, broad-spectrum, synthetic, small molecule antibiotic that has been used clinically for over 50 years for the treatment of acute bacterial infection and has been combined with sulfa-based antibiotics (Bactrim/Septra) for bacterial infection prophylaxis especially in the lung and bladder.
15929342|NCT03424512|Behavioral|Group Metacognitive Therapy|Group MCT is based on a manualised protocol and is structured in the following way. In session 1, idiosyncratic case formulations based on the generic metacognitive model are developed for each participant. Socialization helps patients to understand that worry/rumination and unhelpful coping strategies are maintaining emotional distress. Patients are then introduced to, and practice well established treatment techniques to modify negative beliefs about uncontrollability of rumination/worry. Later sessions address relapse prevention and involves modifying remaining use of the 'cognitive attentional syndrome', reviewing residual conviction in positive and negative beliefs and consolidating and strengthening alternative ways of responding to negative thoughts.
15929343|NCT03424499|Procedure|Single-use catheter|Each urethral catheterization will be done with a new sterile catheter in a period of 8 weeks. Frequency of urethral catheterization will depend of the conditions of each patient (from 3-5 per day). Patients and parents were instructed to use clean technique by hand washing with water and soup, and penis/vulva cleansing with antiseptic wipes. Researchers reinforced the intermittent catheterization technique before the trial.
15929344|NCT03424499|Procedure|Reused catheter|Each catheter is programmed to last 1 week. Evaluation will last a period of 8 weeks. Frequency of urethral catheterization will depend of the conditions of each patient (from 3-5 per day). after catheterization, PVC catheter was washed with water and soap, and stored in a container with 0.5% benzalkonium chloride. Each catheter was programmed to last a week. Patients and parents were instructed to use clean technique by hand washing with water and soup, and penis/vulva cleansing with antiseptic wipes. Researchers reinforced the intermittent catheterization technique before the trial.
15929345|NCT03424499|Diagnostic Test|Urine culture|A midstream urine sample will be obtained using sterile catheterization for urine culture performed by health provider. Urine cultures will be done in days 0, 7, 14, 28, 42 and 56.
15929346|NCT03424486|Other|Questionnaires|Evaluation of the prevalence of anxiety, depression and quality of life
15929347|NCT03424473|Drug|Tucatinib|
15929348|NCT03424460|Biological|Haemostasis tests|Venipuncture of 30 milliliters of blood. The following tests will be performed: thromboelastography (TEG®), standard tests of coagulation, genetic thrombophilia, lupus anticoagulant, fibrinolysis markers (Alpha-2-antiplasmin, amidolytic activity, plasmin anti-plasmin complexes, Plasminogen Activator Inhibitor-1 (PAI-1) antigen, plasminogen amydolytic activity), and a global test of fibrinolytic activity.
15929349|NCT03424460|Biological|Monocytes and megacaryocytes culture and RNA extraction|Venipuncture of 60 milliliters of blood. Monocytes and megacaryocytes culture. RNA extraction from monocytes and megacaryocytes.
15929350|NCT03424460|Genetic|RNA extraction|RNA extraction from liver tissue
15929351|NCT03424447|Procedure|efferent limb stimulation|
15929352|NCT03424434|Other|Survey diffusion|The study consists in a survey diffusion during several weeks by emailing each practitioner and resident and inviting them to participate to a questionnaire about occupational blood exposure. This survey is strictly anonymous. No identity data is required, only age, gender, function, surgical or medical specialty, work quota and hospital group they belong. This survey is diffused in four UHC (Lyon, Grenoble, Clermont-Ferrand and Saint-Etienne) in France.
15929353|NCT03424421|Procedure|subscapular sling|semitendinosus subscapular sling procedure
15929354|NCT03424408|Drug|Aspirin 81 mg|Healthy volunteers will receive 5 days of aspirin 81 mg daily. Following cessation of aspirin, daily blood samples will be collected for serum thromboxane B2 measurement
15929355|NCT03424395|Other|Personalized dietary and wellness program|Single arm intervention containing three periods: (1) run-in (control), (2) personalized advice/counseling and meals, (3) personalized advice/counseling only
15929356|NCT03424369|Procedure|Tympanoplasty|Tympanoplasty
15929357|NCT03424356|Drug|Rocuronium Bromide|0.15 mg/kg rocuronium bromide
15929358|NCT03424356|Drug|Saline Solution|1-2 ml saline solution
15929359|NCT03424356|Drug|Fentanyl|1mcg/kg for induction
15929360|NCT03424356|Drug|Propofol|2-3mg/kg for anaesthetic induction
15929362|NCT03424343|Other|Questionnaire bundle|Questionnaires on identity formation and psychosocial functioning, assessed and reported at baseline, one year later, two years later, and five years later.
15929363|NCT03424343|Other|Obtaining information from survivors' medical file|After obtaining informed consent, we will access the medical file of participants to obtain information on the diagnosis, time of diagnosis, treatment duration, type of treatment, and relapse (when applicable).
15929364|NCT03424330|Device|ReX-C intervention|Patients receive medication by the ReX-C device
15929365|NCT03424330|Other|Standard of Care|Patients receive medication as usual
15929366|NCT03424317|Behavioral|Sodium intake reduction|Provide materials to reduce sodium intake and educate how to reduce sodium intake effectively
15929367|NCT03424317|Behavioral|Exercise|Provides materials on exercise methods to reduce blood pressure and educates how to perform exercise effectively
15929368|NCT03424304|Device|Excel V™ Laser With Green Genesis|Subject(s) will receive 3 to 5 treatments with a Cutera Excel V™ Laser
15929369|NCT03424291|Drug|Apatinib plus chemoradiation|Apatinib 500 mg qd po Taxus + platinum or 5FU + platinum (drug dose reference to clinical) palliative radiotherapy dose ≥ 40Gy and radical radiotherapy dose (60-70Gy)
15929370|NCT03424278|Other|Motor control exercises|Motor control exercises for the deep trunk muscles in patients with chronic low back pain is based on evidence of motor control dysfunction, including delayed onset of activity in the transversus abdomens and internal oblique abdominal muscles and segmental hypertrophy of the lumbar multifidus muscle.
15929371|NCT03424278|Other|Resistance training exercises|A type of strength-building exercise program that requires the body muscle to exert a force against some form of resistance, such as weight, stretch bands, water, or immovable objects. Resistance exercise is a combination of static and dynamic contractions involving shortening and lengthening of skeletal muscles.
15929372|NCT03424265|Dietary Supplement|EAA mixture|Dietary supplement intervention for 12-weeks
15929373|NCT03424265|Dietary Supplement|Placebo (whey protein)|Dietary supplement intervention for 12-weeks
15929374|NCT03424252|Drug|FDL169|Cystic Fibrosis Transmembrane Regulator (CFTR) corrector
15929375|NCT03424239|Drug|Zoledronic Acid|5mg zoledronic acid
15929376|NCT03424239|Dietary Supplement|Calcium citrate + vitamin D|Chewable 500mg calcium citrate with 500 International Units (IU) Vitamin D3
15929377|NCT03424239|Dietary Supplement|Vitamin D3|1000IU Vitamin D3 gummy
15929378|NCT03424226|Drug|Acetazolamide|a diuretic and commonly used medication for prevention and treatment of acute mountain sickness
15929379|NCT03424213|Other|No interventions - retrospective data collection|No new patients will be consented to this study. Only retrospective data will be collected on prostatectomy specimens and correlated with health data
15929380|NCT03424200|Behavioral|Routine care|Participants will receive routine care
15929381|NCT03424200|Other|Coaching plus routine care|Participants will receive coaching plus routine care
15929382|NCT03424187|Dietary Supplement|chickpea|"all three meals are isocaloric but different in the chickpea structure( physical form):
~• Whole chickpea, flour chickpea, intact cell flour chickpea"
15929383|NCT03424174|Device|Coated Total Knee Arthroplasty|Implantation coated Total Knee Arthroplasty
15929384|NCT03424174|Device|Standard Total Knee Arthroplasty|Implantation StandardTotal Knee Arthroplasty
15929385|NCT03424161|Device|Secret RF|Subjects may receive up to 4 treatments
15929386|NCT03424148|Device|Excel V™ Laser & Micro-Lens Array Attach|Subjects will receive up to 6 laser treatments
15929387|NCT03424135|Drug|Naproxen sodium and diphenhydramine hydrochloride soft capsules|Single oral administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 capsules)
15929388|NCT03424135|Drug|Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve PM, BAY98-7111)|Single administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 tablets)
15929389|NCT03424122|Drug|Parsaclisib|Parsaclisib administered orally once daily for 8 weeks followed by once weekly.
15929390|NCT03424122|Drug|Rituximab|Rituximab administered intravenously at the protocol-defined dose regimen according to treatment group.
15929391|NCT03424122|Drug|Bendamustine|Bendamustine administered intravenously on Days 1 and 2 of each cycle for up to 6 cycles.
15929392|NCT03424122|Drug|Ibrutinib|Ibrutinib administered orally once daily.
15929393|NCT03424109|Behavioral|healthcare service utilization in the six months following the ED visit|The analysis of the effect of PRIM-ER on ED disposition using a generalized linear binomial model with random site level effects.
15929394|NCT03424070|Other|Shoulder Roll|The POGO score assesses the percent of the glottic opening that can be seen with and without the shoulder roll.
15929395|NCT03424070|Other|No shoulder roll (placebo)|Placebo
15929396|NCT03424057|Procedure|Asymmetric Primary Closure and Additional Skin Excision Technique|In this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method, but an advancement tissue flap was performed using additional skin excision, in order to reduce the dead-space volume.
15929397|NCT03424057|Procedure|Standard Karydakis technique.|In this new technique, following total sinus excision, the excision defect was closed with the standard Karydakis method
15929398|NCT03424044|Device|Artificial Pancreas Controller in Dual Hormone Mode|The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The algorithm has 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. The Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G5 sensor and sending delivery commands to two Omnipod insulin pumps, one filled with insulin and one with glucagon.
15929399|NCT03424044|Device|Artificial Pancreas Controller in Single Hormone Mode|The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. The Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G5 sensor and sending delivery commands to one Omnipod pump filled with insulin.
15929400|NCT03424044|Device|Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode|The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. The Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G5 sensor and sending delivery commands to one Omnipod insulin pump filled with insulin.
15929401|NCT03424044|Drug|XeriSol glucagon|XeriSol glucagon is an investigational drug that is a stable, soluble liquid glucagon formulation that can be injected or administered through an insulin pump. XeriSol glucagon will be used to fill the Omnipod to deliver glucagon for the Artificial Pancreas Controller in Dual Hormone mode.
15929402|NCT03424031|Procedure|Verticalization|To allow the verticalization of hemiplegic patients, we will use a device commonly used in rehabilitation: the standing (or standing) brand Thera Trainer . This device makes it possible to keep the patient standing despite the motor and postural deficits thanks to knee, buttocks and an anterior support for the upper limbs. Verticalization with this device requires the presence of one or two caregivers (including at least one re-educator), depending on the possibilities of participation of the patient.
15929403|NCT03424018|Drug|BMN 111|Subcutaneous injection of 15 μg/kg of BMN 111 daily
15929404|NCT03424005|Drug|Capecitabine|Capecitabine will be administered 1250 mg/m^2 orally twice daily on Days 1-14, of each 21 day cycle.
15929405|NCT03424005|Drug|Atezolizumab|"For Atezolizumab (Atezo) + SGN-LIV1A, Atezo + Sacituzumab Govitecan, or Atezo + Chemo arms: atezolizumab will be administered intravenously (IV), 1200 mg, on Day 1 of each 21-day cycle.
~For Atezo + Nab-Paclitaxel, Atezo + Selicrelumab + Bevacizumab, Atezo + Ipatasertib, or Atezo + Nab-Paclitaxel + Tocilizumab: atezolizumab will be administered IV, 840 mg on Days 1 and 15, of each 28-day cycle."
15929406|NCT03424005|Drug|Ipatasertib|Ipatasertib will be administered by mouth 400 mg once a day, on Day 1-21 of each 28 day cycle.
15929407|NCT03424005|Drug|SGN-LIV1A|SGN-LIV1A will be administered IV, 2.5 mg/kg (maximum calculated dose 250 mg), on Day 1 of each 21 day cycle.
15929408|NCT03424005|Drug|Bevacizumab|Bevacizumab will be administered IV, 10 mg/kg, on Days 1 and 15 of each 28 day cycle.
15929409|NCT03424005|Drug|Chemotherapy (Gemcitabine + Carboplatin or Eribulin)|"Gemcitabine will be administered by IV, 1000 mg/m^2, along with carboplatin, by IV, AUC 2, on Days 1 and 8 of each 21 day cycle.
~Or
~Eribulin will be administered by IV, 1.4 mg/m^2 on days 1 and 8 of each 21 day cycle."
15929410|NCT03424005|Drug|Selicrelumab|Selicrelumab will be administered by subcutaneous (SC) injection at a fixed dose of 16 mg on Day 1 of Cycles 1 to 4 and every third cycle thereafter (cycle = 28 days).
15929411|NCT03424005|Drug|Tocilizumab|Tocilizumab will be administered IV, 8 mg/kg infusion on Day 1 of each 28 day cycle.
15929412|NCT03424005|Drug|Nab-Paclitaxel|Nab-Paclitaxel will be administered by IV, 100 mg/m^2, on Days 1, 8, and 15 of each 28-day cycle.
15929413|NCT03424005|Drug|Sacituzumab Govitecan|Sacituzumab govitecan will be administered by IV, 10 mg/kg, on Days 1 and 8 of each 21-day cycle.
15929414|NCT03423992|Biological|chimeric antigen receptor T cells|chimeric antigen receptor T cells expressing receptors specific for EGFRvIII, IL13Rα2, Her-2, CD133, EphA2, GD2, respectively
15929415|NCT03423979|Device|Optilume™ BPH Prostatic DCB Dilation Catheter|BPH Prostatic DCB treatment - The Optilume BPH Prostatic DCB Dilation Catheter System should be prepared per the Instructions for Use (IFU).
15929416|NCT03423979|Drug|Paclitaxel|paclitaxel will release to adjacent tissue after the balloon inflated in the urethra
15929417|NCT03423966|Device|Smartphone Pedometer App|Installation of the free pedometer app and explanation to participants to target 10000 steps per day. The intent is not the accuracy of the pedometer but the motivation especially to a community yet to harness the full potentials of the mobile phone technology
15929418|NCT03423953|Device|Comprehensive Nano|Patients requiring the Comprehensive Nano shoulder system.
15929419|NCT03423940|Behavioral|Functional communication training|"During functional communication training (FCT), the social consequence (e.g., attention, toys, breaks from instructions) that heretofore reinforced destructive behavior (i.e., as determined through a functional analysis) is delivered contingent on an appropriate communication response, while destructive behavior is on extinction (i.e., reinforcers are no longer provided). For example, if a functional analysis shows that aggression is reinforced by escape from demands, FCT would typically involve (a) teaching the child to access breaks from demands via a functional communication response (FCR; e.g., saying, Break, please) and (b) placing destructive behavior on extinction (i.e., continuing with scheduled demands independent of destructive behavior)."
15929420|NCT03423940|Behavioral|RaC-enhanced functional communication training|We will use the quantitative predictions of Resurgence as Choice (RaC) Theory to tailor a set of reinforcement-schedule thinning steps for each subject. This quantitative prediction will allow for dynamic decisions regarding how to conduct upcoming treatment sessions, as based on both the subject's recent response to treatment and the RaC equation.
15929421|NCT03423927|Behavioral|Self-hypnosis + Self-care|Our groupal intervention is divided into 6 monthly 2-hour sessions in which one self-hypnosis exercise is proposed to participants. Self-care techniques are also discussed (knowing our own needs, selfrespect, assertiveness, coping with ruminations...) and homework assignments are proposed to participants, in order to foster positive change.
15929422|NCT03423914|Behavioral|Expressive writing|The emotional or expressive writing therapy developed by James Pennebaker has been used as a method of self-understanding in people with high levels of stress, chronic diseases, sexual and physical abuse, natural disasters and job loss, among others. Expressive writing allows and implies revealing the deepest thoughts and feelings of the person about a stressful or traumatic event in life translate emotions into words, and with that, reduce mental stress (decrease in levels of depression, stress and anxiety), strengthen self-esteem and even strengthen the immune system
15929423|NCT03423914|Other|Only Writing|Participants write about knowledge related to infant care during four days
15929424|NCT03423901|Other|Blood sampling|Descriptive analysis of clinical, biological and histological of 3 arms: ABO incompatible, HLA incompatible, and ABO/HLA incompatible kidney transplantation (1 and 5 years posttransplantation in each groups)
15929459|NCT03423576|Behavioral|comprehensive patient-centered outpatient health service with multiple components|Individualized multi-component education and counselling program coordinated by a case Manager.
15929425|NCT03423888|Device|high-flow nasal cannula oxygen therapy (HNFC)|"Set up of high-flow nasal oxygen for patient with dyspnea for a respiratory disease without possibility of curative care. Patients who require a treatment by oxygen are included.
~After 7 days of treatment, acceptability is evaluated by the duration of use of HNFC."
15929426|NCT03423875|Diagnostic Test|PrEDICT game score|PrEDICT game score will be shared with the emergency physicians and health care professionals
15929427|NCT03423862|Other|Mixed Meal Tolerance Test|"After a 10-hour overnight fast (not eating or drinking anything except water), participants will complete a mixed meal tolerance test (MMTT):
~This involves participants drinking a Boost drink, like a milkshake, which will raise participants' blood sugar.
~The amount of Boost will be based on participants body weight, up to a maximum of 360 mL or about 1 ½ cups, and should be consumed within 5 minutes.
~An IV will be placed in participants arm and blood will be drawn from it. Blood will be drawn from the IV before and then 6 times over the next 2 hours after participants drink the Boost."
15929428|NCT03423849|Drug|Vinorelbine|25mg/m2,day 1 and day 8, every 3 weeks
15929429|NCT03423849|Drug|Gemcitabine|1250mg/m2,day 1 and day 8, every 3 weeks
15929430|NCT03423849|Drug|Cisplatin|25mg/m2,day 1,every 3 weeks
15929431|NCT03423849|Drug|Capecitabine|1250mg/m2,day 1 to day 14, every 3 weeks
15929432|NCT03423823|Drug|Ziv-Aflibercept 25 MG/ML [Zaltrap]|Anti-VEGF injection
15929433|NCT03423823|Drug|Ranibizumab|Anti-VEGF standard of care injection
15929434|NCT03423810|Drug|Hydralazine|Participants will be asked to take pills two times per day for 6 weeks. This is a dose increasing study with potential doses ranging from 5 mg two times per day to 50 mg two times per day.
15929435|NCT03423797|Drug|25% AgNO3 solution followed by 5% NaF|Dosage: 25% AgNO3 solution 7.9mg(Ag+)/0.05ml (max dose), 5% NaF: 11.6mg (F-)/0.5ml (max dose).
15929436|NCT03423797|Drug|25% AgNO3 solution followed by 5% NaF with fTCP|Dosage: 25% AgNO3 solution 7.9mg(Ag+)/0.05ml (max dose), 5% NaF with fTCP: 11.6mg (F-)/0.5ml (max dose).
15929437|NCT03423784|Device|HA BPX V3.3|medical device containing HA
15929438|NCT03423784|Other|Dentinox-Gel N|Anaesthetic gel
15929439|NCT03423771|Drug|NPF-08|Drug: NPF-08 Arms: NPF-08 oral sulfate solution
15929440|NCT03423758|Other|Blood sample|Blood sample
15929441|NCT03423732|Drug|CardioCell|"Patients in the N-O CLI trial will receive a full dose of IMP three times during the trial: at baseline, after 45 days post index administration and after 3 months post index administration.
~IMP will be administered into femoral artery and intramuscularly with 50:50 proportion. The intramuscularly dose will be administered into muscles above and below the knee in 50:50 proportion."
15929442|NCT03423732|Drug|Placebos|"Patients randomized to the control group will receive 0.9% NaCl and 5% albumin injections (in the same volume as CardioCell) in the same manner.
~Control group will receive the same amount of fluid used for WJMSCs preparation, without cells."
15929443|NCT03423719|Dietary Supplement|Fiit-ns®|Fiit-ns® is a blend of polyphenol-rich extracts from grapefruit, grape, green tea, guarana and black carrot. It also provides Vitamin B3. Daily dosage is 900 mg in two 450 mg-capsules for 16 weeks.
15929444|NCT03423719|Dietary Supplement|Placebo|Placebo product is 100% maltodextrin. Daily dosage is 900 mg in two 450 mg-capsules of identical appearance than the supplement capsule for 16 weeks.
15929445|NCT03423706|Procedure|the new model of haplo-HSCT for r/r B-ALL|take advantage of high-dose CTX、CD19-CART、donor CD34+HSC and Tregs to create a new model of haplo-HSCT for the patients in r/r B-ALL,to improve the quality of HSCT.
15929446|NCT03423693|Other|No any intervention|No any intervention is applied to any groups in this study
15929449|NCT03423667|Drug|N-acetylcysteine|N-acetylcysteine (1200 mg) administered twice a day during 5 days
15929450|NCT03423667|Drug|Lactose powder|Placebo comparator.
15929451|NCT03423654|Other|Spatial Training|Spatial Training using a 5x5 grid
15929452|NCT03423654|Other|Letter number matching|Letter number matching
15929453|NCT03423641|Drug|Direct Acting Antivirals|The time period during which a patient is dispensed the medication and for up to 180 days after initiation of the medication.
15929456|NCT03423615|Behavioral|Comprehensive Health & Hygiene Improvement Program (CHHIP)|CHHIP is an intense, multi-component holistic school health program based on the WHO Health Promoting School framework and designed for implementation by lay fieldworkers.
15929457|NCT03423602|Device|PerQseal®|Large hole closure system
15929458|NCT03423589|Dietary Supplement|VSL#3|VSL#3 is a commercially available probiotic supplement manufactured and distributed by Alfasigma USA, Inc of Covington, Louisiana, USA. As with other probiotics, VSL#3 is considered a supplement and is not FDA-approved or regulated. VSL#3 contains eight probiotic strains: bifidobacteria (B. longum, B. infantis, and B. breve), lactobacilli (L. acidophilus, L. casei, L. bulgaricus, and L. plantarum) and Strepococcus thermophiles.
15929460|NCT03423563|Device|Flexible fiberoptic bronchoscopy|Flexible fiberoptic bronchoscopy versus flexible intubation video endoscope regarding intubation time in obese patients
15929461|NCT03423563|Device|Fexible intubation video endoscopy|Fexible intubation video endoscopy
15929462|NCT03423537|Drug|hCG|the addition of hCG (Pregnyl®, MSD Greece) will begin with the administration of gonadotrophin at a dose of 100 IU per day, administered subcutaneously, and will continue until the administration of hCG for follicular maturation.
15929463|NCT03423537|Drug|Placebo|100IU per day containing N/S 0.9% will be injected
15929464|NCT03423524|Device|Micropure 1.2.3.|"Implantation of intraocular lens (IOL). Name: MicroPure 1.2.3. It is a monofocal intraocular lens consisting of hydrophobic acrylic material. One IOL per eye will be implanted"
15929465|NCT03423511|Device|MiStent II coronary artery stent|Implantation of a coronary stent patient with stable and unstable coronary artery disease including non-ST-Elevated Myocardial Infarction
15929466|NCT03423511|Device|Xience or Promus coronary artery stents|Implantation of a coronary stent patient with stable and unstable coronary artery disease including non-ST-Elevated Myocardial Infarction
15929467|NCT03423498|Other|toe-spread-out exercise|The therapeutic intervention lasted 14 days and focused on doing the TSO exercise. This exercise was performed unilaterally under the supervision of a qualified physiotherapist. The starting position of the TSO exercise was the sitting position with the knee joint and hip bent at 90 degrees. The exercise consisted of 3 consecutive phases: dorsiflexion of the toes keeping the metatarsal heads and the heel on the ground, moving the fifth toe down and in a lateral direction, moving the big toe down and abduction. The final position needs to be maintained for 5 seconds. The whole sequence was repeated 200 times a day.
15929468|NCT03423485|Device|CG-100 Intraluminal Bypass Device|Intended to reduce contact of fecal content with an anastomotic site , following colorectal surgery.
15929469|NCT03423472|Behavioral|Orange Fleshed Sweet Potato (OFSP) agriculture promotion and nutrition education on vitamin A intake|Support to farmers to grow and store OFSP in the form of agricultural extension, community based trainings and supplies, while simultaneously increasing community demand for OFSP through community-based Healthy Living Clubs. The Clubs promote OFSP, provide nutrition education, and conduct community mobilization events and social marketing of OFSP and OFSP-based processed products. Special emphasis is on women and children < 2y; especially diet diversity and vitamin A intake.
15929470|NCT03423472|Behavioral|Healthy Baby Toolkit|The toolkit consists of a demarcated bowl, a slotted spoon, and a counseling card. The demarcations on the bowl guide caregivers on age-specific meal volume and frequency. The slotted spoon promotes thicker food consistency - and therefore nutrient density - by cuing caregivers when food drips through the slots. The counseling card relies on images rather than text to reinforce messages of the previous two instruments, promote dietary diversity, and promote hygienic food preparation.
15929471|NCT03423472|Behavioral|Standart of care|Government standard of care for nutrition education through the Health Development Army
15929472|NCT03423459|Device|TAVR|Transcatheter Aortic Valve Replacement
15929473|NCT03423446|Drug|Telotristat Ethyl|Telotristat ethyl (TE) 250 mg (1 x 250-mg tablet), single dose
15929474|NCT03423433|Behavioral|Heel raise intervention|A daily heel-raise programme for ten weeks to determine any chronic effects of heel raises on the previously mentioned variables.
15929475|NCT03423407|Device|Positron Emission Tomography-Magnetic Resonance Imaging (PET-MRI)|FDA approved scanner
15929476|NCT03423394|Behavioral|Motivational Enhancement Therapy|The MET intervention will consist of three 45-90 minute telephone delivered sessions that will be staggered to occur 1 week, 1 month, and 2 months after the baseline assessment. The first MET session intervention will involve a counselor using motivational interviewing (MI) strategies to establish an empathic therapeutic relationship and focus learning about the PTSD symptoms the participant is experiencing and exploring ambivalence about seeking treatment services. MET sessions 2 and 3 will focus on identifying and responding to risk factors for dropping out of treatment (increases in ambivalence, avoidance behavior, concerns about stigma, life chaos), identifying and responding to barriers to participant's active engagement in treatment, and facilitating enrollment in alternate therapeutic resources if necessary.
15929477|NCT03423394|Behavioral|Treatment as Usual|TAU will include a written referral list comprised of PTSD resources including information on in-person treatments, self-help, web-based and bibliotherapy options. At the completion of the study, participants in the TAU condition will be offered the MET intervention.
15929478|NCT03423381|Other|Cereal product 1|Cereal products based on rye, barley, wheat, oat, and corn
15929479|NCT03423381|Other|Cereal product 2|Cereal products based on rye, barley, wheat, oat, and corn
15929480|NCT03423381|Other|Cereal product 3|Cereal products based on rye, barley, wheat, oat, and corn
15929481|NCT03423381|Other|Cereal product 4|Cereal products based on rye, barley, wheat, oat, and corn
15929482|NCT03423381|Other|Cereal product 5|Cereal products based on rye, barley, wheat, oat, and corn
15929483|NCT03423381|Other|Control product|A cereal based product with low concentrations of df
15929484|NCT03423368|Device|Libramed|Policaptil Gel Retard
15929485|NCT03423368|Device|Placebo|Placebo-comparator
15929486|NCT03423355|Drug|Dapagliflozin 10mg|10mg p.o. daily
15929487|NCT03423355|Drug|Hydrochlorothiazide 25 mg|25mg p.o. daily
15929488|NCT03423342|Dietary Supplement|nicotinamide riboside|nicotinamide riboside capsule
15929489|NCT03423342|Drug|Placebo|matching placebo capsule
15929490|NCT03423329|Drug|Brufen|Brufen Syrup
15929491|NCT03423329|Drug|Cital|Cital Cyrup
15929492|NCT03423329|Drug|Placebo for Brufen|Sansovit Syrup
15929493|NCT03423316|Behavioral|Supervised exercise therapy|The therapy will be conducted three times each week for 12 weeks. Each session takes 1 hour, consisting of 5 minutes of warmup activities, 50 minutes of intermittent exercise, and 5 minutes of cool-down activities. Exercise consists of walking on a treadmill initiated at 2 mph and 0% grade, until claudication pain becomes moderately severe. After claudication pain subsides, the subject will restart the walk. At the end of the session, the total exercise duration will be recorded. After a patient is able to walk 8-10 minutes at the initial workload, the grade is increased by 1-2%, or the speed is increased by 0.5 mph as tolerated.
15929494|NCT03423303|Diagnostic Test|Prostate cancer screening|Depending on each diagnostic test result the participants in the screening arm will undergo PSA-testing, 4Kscore determination, MRI, and MRI/US fusion biopsy only.
15929495|NCT03423290|Device|FRED and FRED Jr|Flow Re-Direction Endoluminal Device
15929496|NCT03423277|Device|Easy Stretch Toolkit|Study the use of novel intraoral tools for management of facial burns and other facial disorders
15929497|NCT03423264|Drug|Gabapentin|"Gabapentin taken as follows:
~Day 1 (evening): 600 mg Day 2 (morning): 600 mg Day 2 (evening): 600 mg Day 3 (morning): 600 mg Day 3 (evening): 900 mg Day 4 (morning): 900 mg Day 4 (evening): 900 mg Day 5 (morning): 900 mg Day 5 (noon): 900 mg Day 5 (evening): 900 mg"
15929498|NCT03423238|Other|Exercise|Each exercise session lasts for 60 to 90 minutes and consists of 5-10 minutes of warm-up and cool-down activity; up to 30 minutes of aerobic exercise using a variety of modalities (e.g., walking laps on a track, cycle ergometry, treadmills, stair climbers); and 15-20 minutes of upper and lower body resistance exercises using Thera-Bands. An exercise physiologist creates an individualized plan
15929499|NCT03423238|Behavioral|Health Education|Group education classes conducted by an exercise physiologist and/or dietitian are designed to provide support and general information on healthy lifestyle behaviors. Topics include risk factor control, diabetes, hypertension, lipids, medications, aerobic exercise, strength training and flexibility, weight control, reading food nutrition labels, eating out, holiday eating, intimacy, stress, relaxation, cardiac symptoms, and cardiac interventions.
15929500|NCT03423238|Other|Exercise Compliance|Multiple behavioral management strategies to create a positive exercise environment and promote adherence and retention will be utilized. These include promptly contacting participants who miss a session, scheduling makeup sessions, and offering individual counseling sessions to discuss strategies to promote attendance and limit obstacles to participation.
15929501|NCT03423238|Dietary Supplement|Calorie-Restricted Diet|Diet plans will provide a caloric deficit of 500 kcals per day. The lowest calorie level permitted will be 1,100 kcals for women and 1,200 kcals for men. The calorie distribution goal will be 15-20% from protein, <30% from fat, and 45-60% from carbohydrates. Participants will consume 2 meal replacements per day (Premier Protein shakes and bars); provided by the study)), along with one meal composed of traditional foods (500-750 kcals, low in fat, high in vegetables), and 1-3 snacks as needed (e.g., cereal bar, fruit, or vegetable, providing 100-150 kcals each). For the meal, patients will follow a weekly menu plan and recipes provided by the study. The food plan will be tailored to individual preferences and energy needs.
15929502|NCT03423238|Behavioral|Behavioral Modification|During months 1-3, participants will attend weekly individual behavioral counseling sessions with the study registered dietitian (RD); individual sessions will be held twice per month during months 4-6. The sessions will focus on self-monitoring, portion control, mindful eating, coping with negative thoughts, eating at regular times, and stress management. The RD will review individual progress, solve problems, answer questions, and set weight loss goals. At the end of the 6-month weight loss intervention, the RD will meet with participants to devise a weight maintenance strategy, including sample meal plans.
15929503|NCT03423238|Other|Weight-Loss Compliance|Participants will be asked to record their food and beverage intake in daily logs which will be reviewed weekly by the RD to verify compliance to the diet. Body weight will be measured weekly to ensure that participants are losing weight at an appropriate rate. If a participant is not meeting weight loss goals, energy intake will be modified accordingly to produce the desired rate of weight loss.
15929504|NCT03423238|Other|Dietary Counseling|Participants have one meeting with the Rehab dietitian upon starting.
15929505|NCT03423225|Drug|ADVAGRAF®|"Administration method The total daily dose of tacrolimus will be converted to 1:1 (mg:mg) and the total daily dose of ADVAGRAF® will be administered only once daily in the morning, starting from Day 1 (at least one hour before breakfast or 2 to 3 hours after breakfast).
~Dose adjustment after conversion On Day 1, the total dose will be converted to 1:1. It is recommended to check the blood concentration of tacrolimus at each visit and adjust the dose to achieve the blood concentration maintaining at 5~8ng/ml for 0 to 3 months and then at 5ng/ml or below for 3 to 6 months of study treatment.
~Duration of treatment The investigational product will be administered for 24 weeks."
15929506|NCT03423212|Behavioral|Just Do You|Just Do You is an intervention designed to keep young adults connected to their professional behavioral health treatments. It is a brief two-module engagement program that utilizes a hybrid provider team of a licensed clinician and peer to increase young adult engagement in adult outpatient day programs (i.e., New York State Personalized Recovery Oriented Services). The first session consists of the following components: 1) Welcome; Group Guidelines, Purpose, 2) Discuss Recovery Principles; Narrative of Role Model; 3) Video of Celebrity Service User and Discussion, and 4) Recovery Goals (and role of services in that). The second session consists of: 1) What are services & how can they help? 2) Visual art exercise -- Cause of SMI and validation, 3) Maintaining my Medicaid Insurance, and 4) Discussion of Systemic Barriers.
15929507|NCT03423212|Behavioral|Active Control|The active control condition will receive the PROS program that is standard in the agencies, and a two-session curriculum on maintaining healthy relationships, which is an identified issue for the population.
15929508|NCT03423199|Drug|Palbociclib|Palbociclib, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
15929509|NCT03423199|Drug|Placebo|Placebo, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
15929510|NCT03423199|Drug|Tamoxifen|Tamoxifen, 20mg, orally once daily (continuously)
15929511|NCT03423199|Drug|Goserelin|For pre/perimenopausal patients only: Goserelin, 3.6 mg, subcutaneously every 4 weeks; or 10.8 mg, subcutaneously every 12 weeks
15929512|NCT03423186|Drug|SOBI003|Weekly i.v.infusion
15929513|NCT03423173|Biological|TAK-003|TDV subcutaneous injection
15929514|NCT03423173|Biological|Placebo|TDV Placebo-matching normal saline (0.9% NaCl) subcutaneous injection
15929516|NCT03423147|Drug|2% chlorhexidine gluconate cloth|applied to their abdomen
15929517|NCT03423147|Drug|4% Chlorhexidine gluconate vaginal scrub|applied as a vaginal cleanse in the operating room prior to cesarean section
15929518|NCT03423134|Other|New adhesive strip|This is a strip made of a newly developed adhesive
15929519|NCT03423121|Drug|Tauroursodeoxycholic Acid|Participants will be given 1 gram of Tauroursodeoxycholic acid twice daily in the form of four 250mg capsules.
15929520|NCT03423121|Drug|Placebo oral capsule|Participants will be given four capsules of the placebo twice daily.
15929521|NCT03423108|Behavioral|G150|This group will receive 150 min/week of combined exercise training, structured and supervised.
15929522|NCT03423108|Behavioral|G300|This group will receive 300 min/week of combined exercise training, structured and supervised.
15929523|NCT03423095|Behavioral|Active Jaw Exercise with Relaxation|This is the control group that will complete exercises unrelated to the primary outcome measures.
15929524|NCT03423095|Behavioral|Active Tongue Exercise|This is the active comparator group that will complete exercises already shown to increase tongue strength measures.
15929525|NCT03423095|Behavioral|Active Tongue Exercise + Mental Practice|This is an experimental group that will complete active tongue and mental tongue exercises to assess effect on tongue strength measures.
15929526|NCT03423095|Behavioral|Mental Practice Tongue Exercise|This is an experimental group that will complete mental tongue exercises only to assess effect on tongue strength measures.
15929527|NCT03423082|Drug|18F fluciclovine|Each subject will receive one IV dose of 18F fluciclovine for PET scanning
15929528|NCT03423082|Device|18F fluciclovine PET|Each subject will undergo one 18F fluciclovine PET scan on a hybrid PET/MRI scanner
15929529|NCT03423069|Dietary Supplement|Diet low in FODMAPs|A strict restriction of all high FODMAP foods for the time of observation. All these foods will be identified by appropriate nutritional visits and alternatives will be suggested to ensure the diet is nutritionally adequate.
15929530|NCT03423069|Dietary Supplement|Specific dietary advice for IBS|Dietary recommendations such as limitation of alcohol, spicy food and fatty foods, caffeine, carbonated drinks; avoidance of chewing gums and sweeteners containing polyols; small and frequent meals; avoidance of stressful conditions and eating slowly.
15929531|NCT03423056|Other|Preoperative exercise program|Individualized aerobic training program developed by physical therapist using Karvonem's equation . It will programmed in 3 sessions/week (not in row) during 4 weeks. Each 50-minutes session will be organized in three phases: warm up, central and back to calm. The heart rate target will be prescribed between 50 to 70% of the maximum heart rate and will be carried on a treadmill or in a stationary bicycle.
15929532|NCT03423043|Radiation|Low Dose CT Scan of the Wrist|A low dose CT scan will be obtained in patients with a distal radius fracture of the wrist.
15929533|NCT03423030|Drug|PBTZ169 Formulation|PBTZ169 Formulation supplied as powder for oral solution
15929534|NCT03423030|Drug|Placebo|matching placebo supplied as powder for oral solution
15929535|NCT03423030|Drug|PBTZ169 NCP|PBTZ169 NCP supplied as powder for oral solution
15929536|NCT03423017|Other|Recording of data|"Recording during one hospitalization of 48 hours between birth and 2 months of life and one hospitalization of 24 hours between 6 and 10 months of life
~General data: age, term of birth, birth weight, gender, diseases, weight and size at recording, cranial perimeter, food, drugs : first and second visit
~Respiratory rate, respiratory signs, stridor : first and second visit
~24h holter-ECG : first and second visit
~24h impedance pH-metry : first visit
~Nocturne polysomnography : 50% prone position, 50% supine : sleep analyze, obstructive apnea hypopnea index (OAHI), central apnea index (CAI), periodical breathing, micro arousals index, non-nutritive swallowing analyze,(mental region electromyogram) : first and second visit
~24 h gaz exchanges : mean, maximal PtcCO2 and % of time spent above 50 mmHg , SpO2 under 90%, 85% et 80% and desaturations index : first and second visit
~succimetry procedure : at first visit only between birth and 2 months"
15929537|NCT03423017|Other|Recording of data|"Recording during one hospitalization of 48 hours between birth and 2 months of life
~General data: age, term of birth, birth weight, gender, diseases, weight and size at recording, cranial perimeter, food, drugs
~Respiratory rate, respiratory signs, stridor
~24h holter-ECG
~24h impedance pH-metry
~Nocturne polysomnography : 100% supine position : sleep analyze, obstructive apnea hypopnea index (OAHI), central apnea index (CAI), periodical breathing, micro arousals index, non-nutritive swallowing analyze,(mental region electromyogram)
~24 h gas exchanges : mean, maximal PtcCO2 and % of time spent above 50 mmHg , SpO2 under 90%, 85% et 80% and desaturations index
~Succimetry procedure : at first visit only between birth and 2 months"
15929538|NCT03423004|Procedure|Biopsy|the sample will be taken by superficial cutaneous biopsy in psoriasic patients
15929539|NCT03422991|Other|Blood sampling and Quality of life questionnaire.|Blood sampling and Quality of life questionnaire.
15929540|NCT03422978|Drug|Dexmedetomidine|Single dose dexmedetomidine administered over 60 seconds post-induction.
15929541|NCT03422978|Drug|Normal saline|Single dose normal saline administered over 60 seconds post-induction.
15929542|NCT03422965|Diagnostic Test|Optical Coherence Tomography Angiography|Optical Coherence Tomography Angiography images capture.
15929543|NCT03422965|Diagnostic Test|Blood test|Blood test, systemic markers
15929544|NCT03422965|Diagnostic Test|Urine test|Urine test, systemic markers
15929545|NCT03422939|Other|there was no intervention, only separate analyses|We only conducted separate analyses to see if responses differed according to level of experience.
15929546|NCT03422926|Behavioral|Social marketing campaign|Messaging campaign designed to help mothers in choosing healthful options when dining out.
15929547|NCT03422913|Procedure|controlled low central venous pressure|Anesthesiologists will control the amount of fluid input and the use of composite intravenous anesthesia to make CVP at 0~5cm H2O, if CVP is still >5cm H2O, intravenous infusion of nitroglycerin will be used to reduce CVP. Maintaining arterial systolic blood pressure (SBP) > 90 mmHg, urine output more than 1ml/kg/h, and CVP was continuously monitored. Arterial pressure, pulse oxygen saturation ( SPO2), PaCO2 and electrocardiogram (II and V5 leads) were continuously monitored by radial artery cannulation. CVP will Returned to normal level (6 ~ 12 cmH2O) after resection to observe the wound if active bleeding still exist. Intraoperative hepatic blood flow blocking intermittent Pringle block method also required during surgery, 10-15 minutes for once, and more than 5 minutes interval can be repeated.
15929548|NCT03422900|Dietary Supplement|Diabetes-Specific enteral formula|Complete enteral formula normocaloric hyperproteic with fiber (80% SOLUBLE)
15929549|NCT03422900|Dietary Supplement|Standard formula|Complete enteral formula normocaloric hormoproteic without fiber
15929550|NCT03422887|Drug|Nalbuphine|Nalbuphine administration during surgery
15929551|NCT03422887|Drug|Flurbiprofen Axetil|Flurbiprofen axetil administration during surgery
15929552|NCT03422887|Drug|Nalbuphine and Flurbiprofen Axetil|Nalbuphine and Flurbiprofen Axetil administration during surgery
15929553|NCT03422874|Drug|MLN9708|MLN9708 is a second-generation reversible proteasome inhibitor which shows greater oral bioavailability, improved pharmacokinetics and enhanced antitumor activity compared with bortezomib (VELCADE®).
15961763|NCT03175289|Other|Questionnaire Administration|Ancillary studies
15929554|NCT03422874|Drug|Nelfinavir|Nelfinavir is an oral HIV protease inhibitor approved by FDA in 1997, now available in generic form. It has a well established safety profile in HIV patients when administered at the recommended dose of 1250 mg PO BID. Nelfinavir was shown to induce ER stress in cancer cell lines and xenograft tumors leading to apoptosis and tumor growth inhibition.
15929555|NCT03422861|Drug|Nabilone|Treatment regimen will involve nabilone capsule administration starting with 1mg BID orally first administered on POD #0. The patient will be continued on this medication for 72 hours
15929556|NCT03422861|Drug|Placebos|Treatment regimen will involve placebo capsule administration, identical in colour, shape, size, taste and smell to the nabilone capsules, starting orally first administered on POD #0. The patient will be continued on this medication for 72 hours
15929557|NCT03422848|Dietary Supplement|Water|Increased daily water intake with 1.5 L of water on top of habitual water intake.
15929558|NCT03422848|Behavioral|general life style advice|oral and written advice on diet and physical activity
15929559|NCT03422835|Procedure|R-TME|Conventional Robotic Total Mesentery Excision
15929560|NCT03422835|Procedure|R-TaTME|Robotic Transanal Total Mesentery Excision
15929567|NCT03422796|Drug|Cilostazol 200mg|Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
15929568|NCT03422796|Drug|SUMAtriptan 6 MG/ML|Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
15929569|NCT03422796|Drug|Placebo|Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
15929570|NCT03422783|Device|Standardized tetanic stimulation|"The intervention is not a drug, but it is standardized electrical stimulus applied with a muscle relaxation monitor on the forearm of the anesthetized patient. The NoL index is registered in response to this stimulus in an observational manner.
~Device: Device PMD200TM offering intraoperative NoL Index"
15929571|NCT03422783|Diagnostic Test|Catastrophizing score|Pre-operative catastrophizing score is correlated with post-operative pain and opioid consumption
15929572|NCT03422783|Diagnostic Test|Nociceptive threshold|Nociceptive threshold for pressure, heat and electrical stimulation are associated with post-operative pain and will be assessed preoperatively to see if there is correlation between them and the NOL index response to the nociceptive stimulus (see intervention 1)
15929573|NCT03422783|Biological|Biomarkers|Some biomarkers of inflammation and endogenous opioids are associated with post-operative pain. Blood samples will be withdrawn at D0 before surgery starts, D1 (H24) and D2 (H48) after surgery to see if they correlate with NOL changes after the stimulus described in intervention 1 above
15929574|NCT03422770|Diagnostic Test|Echocardiography|Conventional transthoracic echocardiography will be performed, in addition 3D-imaging and acquisitions with high frame rate. The data from these patients will be anonymized and transferred for post-hoc analysis in dedicated computer software (GE Vingmed, EchoPac 2.0) and in validated machine learning algorithms.
15929575|NCT03422770|Diagnostic Test|MRI|Cardiac MRI will be performed. In all patients without contraindications a gadolinium-based contrast agent will be given.
15929576|NCT03422770|Diagnostic Test|Blood test|Conventional brachial venous blood samples will be drawn. Blood samples will be analyzed for markers of myocardial fibrosis at Oslo University Hospital.The findings will be related to imaging findings.
15929577|NCT03422770|Diagnostic Test|ECG and Holter-ECG|ECG/Holter-ECG will be performed, and the findings will be related to the imaging findings.
15929578|NCT03422770|Diagnostic Test|6 min walking test|6 MWT will be performed, and the findings will be related to findings from MRI/echocardiography.
15929579|NCT03422757|Device|adaptive Deep Brain Stimulation|"The investigational medical device (AlphaDBSvext) is a portable, external, dual mode stimulator that can deliver adaptive DBS or conventional DBS for the treatment of PD.
~In the adaptive mode, the device records Local Field Potential activity from the implanted DBS electrode and simultaneously delivers stimulation through the same electrode based on the recorded signal."
15929580|NCT03422757|Device|conventional Deep Brain Stimulation|"The same investigational medical device (AlphaDBSvext) is used to deliver conventional DBS for the treatment of PD. In the conventional mode it delivers constant stimulation."
15929581|NCT03422744|Procedure|trans bronchial biopsy guided by echo-endoscopic miniprobes|We get a sample trough transbronchial biopsy guided by echo-endoscopic miniprobe.
15929582|NCT03422744|Procedure|if first one negative: samples under fluoroscopic control|If no diagnosis with first intervention we get a second sample by cytological smear, fine needle biopsy and transbronchial biopsy under fluoroscopic control
15929583|NCT03422731|Procedure|Biospecimen Collection|Undergo collection of bone marrow and blood samples
15929584|NCT03422731|Procedure|Dual-Energy Computed Tomography|Undergo DECT
15929585|NCT03422731|Drug|Fluorothymidine F-18|Undergo FLT PET
15929586|NCT03422731|Other|Laboratory Biomarker Analysis|Correlative studies
15929587|NCT03422731|Procedure|Magnetic Resonance Imaging|Undergo water-fat MRI
15929588|NCT03422731|Procedure|Positron Emission Tomography|Undergo FLT PET
15929589|NCT03422718|Behavioral|Healthy Behavior Texts|Participants receive motivational health behavior texts
15929590|NCT03422718|Behavioral|No healthy behavior texts|Participants do not receive healthy behavior texts
15929591|NCT03422718|Behavioral|BP Monitoring Daily Via Text Messaging|Daily text messages will prompt participants for BP by home cuff
15929592|NCT03422718|Behavioral|BP Monitoring Weekly Via Text Messaging|Weekly text messages will prompt participants for BP by home cuff
15929593|NCT03422718|Behavioral|Physician appointment and transportation scheduling|Participants receive assistance scheduling physician appointment and transportation to those appointments
15929594|NCT03422718|Behavioral|No physician appointment and transportation scheduling|Participants do not receive assistance scheduling physician appointment or transportation
15929595|NCT03422705|Device|Optimised programming|Optimised programming to avoid RV pacing when possible.
15929596|NCT03422705|Drug|Lisinopril|Uptitration of lisinopril
15929597|NCT03422705|Other|Standard care|No pacemaker adjustment or medical therapy
15929598|NCT03422692|Biological|BioXclude amnion-chorion membrane|BioXclude will be used for the prevention of alveolar ridge resorption via socket bone graft and amnion-chorion membrane closure
15929599|NCT03422692|Biological|Mem-Lok collagenous membrane|Mem-Lok will be used for the prevention of alveolar ridge resorption via socket bone graft and collagenous membrane closure
15929600|NCT03422679|Drug|CB-103|Capsules, taken once daily during treatment period A and B. Treatment cycle is 28 days.Starting dose is 15 mg.
15929601|NCT03422666|Drug|Teduglutide|Teduglutide
15929602|NCT03422666|Drug|Placebo|Placebo
15929603|NCT03422653|Drug|CR845 0.5 mcg/kg|IV medication delivered three times/week
15929604|NCT03422653|Drug|Placebo|IV medication delivered three times/week
15929605|NCT03422640|Drug|Apremilast|Open label treatment with apremilast
15929608|NCT03422614|Diagnostic Test|Diagnostic Test|Characterisation of cellular and functional phenotype in different PIDs
15929609|NCT03422601|Diagnostic Test|Immunoscore test|To identify patients with high risk (IS 0-1) of relapse or death under oxaliplatin-based adjuvant therapy.
15929610|NCT03422588|Procedure|Laparoscopic right colectomy|Laparoscopic right colectomy for colorectal cancer with a standard vascular dissection, performing the anastomosis with a side-to-side mechanical anastomosis fashioned intracorporeally versus extra corporeally
15929611|NCT03422575|Drug|Etoricoxib 120Mg Film-coated Tablet|One tablet of the Test drug was given orally (swallowed with 200 mL of water, without chewing), after an overnight fast, and after fasting (pre-dose) blood-sampling.
15929612|NCT03422575|Drug|Arcoxia® 120 mg Film-coated tablet (Frosst Iberica S.A., Spain for Merck Sharp & Dohme (Australia) Pty Limited, Australia, registered by PT. Schering-Plough Indonesia Tbk)|One tablet of the Reference drug was given orally (swallowed with 200 mL of water, without chewing), after an overnight fast, and after fasting (pre-dose) blood-sampling.
15929613|NCT03422562|Dietary Supplement|Florababy|Probiotic supplement
15929614|NCT03422549|Device|Drager VN500 Ventilator|This ventilator is capable of providing both CPAP and NHFOV support.
15929615|NCT03422536|Biological|Cetuximab|Given IV
15929616|NCT03422536|Drug|Ficlatuzumab|Given IV
15929617|NCT03422523|Drug|Atezolizumab|Intravenous drip
15929618|NCT03422523|Drug|Rituximab|Intravenous drip/or Subcutaneous from cycle 2
15929619|NCT03422523|Drug|Gemcitabine 1000 mg|intravenous drip
15929620|NCT03422523|Drug|Oxaliplatin 100 MG|intravenous drip
15929621|NCT03422510|Drug|CXA-10|CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitro-oleic acid (OA-NO2)
15929622|NCT03422497|Other|Male sex|Male sex-as listed in the discharge abstract database
15929623|NCT03422497|Other|Female sex|Male sex-as listed in the discharge abstract database
15929624|NCT03422484|Other|Detection and correction of medication error at hospital admission|Detection and correction of medication error at hospital admission
15929625|NCT03422471|Other|Hyperinsulinemic Hypoglycemic Clamp|Participants will receive two 90 minute sessions of hypoglycemia. Baroreflex sensitivity will be assessed before, after, and during the sessions.
15929626|NCT03422458|Device|Alveolar Ridge Preservation|Insertion of a bone substitute material (BioOss Collagen) within the bony envelope at least to the level of the palatal/ lingual bone plate. Adaptation of a collagen matrix (Mucograft Seal) to the soft tissue borders.
15929627|NCT03422445|Drug|Apatinib|Apatinib：500mg/d，qd，po，d1-28
15929628|NCT03422445|Drug|Temozolomide|Temozolomide：300mg/d，qd，po，d1-5
15929629|NCT03422432|Procedure|HIPEC|All HIPEC will be with Mitomycin C and given at a dose of 10mg/body surface area.
15929630|NCT03422419|Drug|Heparin|The choice of the anticoagulant medication in terms of duration and dose will be determined by the treating physician.
15929631|NCT03422419|Device|TIPS|transjugular intrahepatic portosystemic shunt deployment
15929632|NCT03422406|Other|Dietary iodine intake restriction|All subjects with excessive iodine load were recommended by nutritionists to restrict dietary iodine intake, and resume iodine-containing supplements and foods until their iodine status return to normal. However, in this observational study, the intervention was a regular management in prenatal care, and not assigned by investigator of the study.
15929633|NCT03422393|Drug|Venetoclax|On cycle 1, day 1, patients will initiate venetoclax. The dose of venetoclax will ramp-up from 20 mg PO daily to 400 mg PO daily over a 5 week period.
15929634|NCT03422393|Drug|Ibrutinib|"During the screening period, patients will continue on ibrutinib at their previous tolerated dose, unless required to stop (e.g.: by a preceding clinical trial).
~On cycle 1, day 1, the dose of ibrutinib will be assigned based on the dose cohort. Patients in cohort 1 will receive ibrutinib 420 mg PO daily. Patients in cohort 2 will receive ibrutinib 560 mg PO daily. Cohort 3 will be 840 mg PO daily."
15929635|NCT03422367|Behavioral|JASPER|JASPER (Joint Attention, Symbolic Play, Engagement, and Regulation) is a treatment approach based on a combination of developmental and behavioral principles developed by Dr. Connie Kasari and Dr. Amanda Gulsrud at UCLA. It targets the foundations of social communication (joint attention, imitation, play) and uses naturalistic strategies to increase the rate and complexity of social communication.
15929636|NCT03422354|Procedure|Ultrasound guided PVB with General Aneasthesia|An 18G Tuohy needle was inserted perpendicularly at L1,2 to hit the transverse process via an out-of-plane approach. This then directed over the top of the bony structure. The deviation of the needle was kept at 15°. The space was identified using loss of resistance without U/S After negative aspiration, Transverse process visualisation was possible. Distances measured using U/S correlated well with needle depth. Injection of local anaesthetic was visualised as turbulence at L1,2 in all patients. The onset time for this block is 15-25 min
15929637|NCT03422354|Device|Ultrasound|Ultrasound
15929638|NCT03422354|Drug|Paravertebral block|Patients will receive single shot L1-L2 PVB before undergoing GA
15929639|NCT03422354|Drug|General Aneasthesia|General Aneasthesia
15929640|NCT03422341|Device|Comparison between GenePOC CR and Reference Method|The collected swab will be tested with both the GenePOC Strep A, C/G assay and the Reference Method defined as standard microbiology culture and strain identification using a MALDI TOF.
15929642|NCT03422315|Drug|Propofol|injection;2mg/kg;single-dose
15929643|NCT03422302|Device|Biphasic Positive Airway Pressure|Receive BiPAP
15929644|NCT03422302|Procedure|Computed Tomography|Undergo CT simulation scans
15929645|NCT03422302|Procedure|Continuous Positive Airway Pressure|Receive CPAP
15929646|NCT03422302|Procedure|Deep Inspiration Breath Hold|Complete DIBH
15929647|NCT03422302|Radiation|Radiation Therapy Treatment Planning and Simulation|Undergo CT simulation scans
15929648|NCT03422302|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15929649|NCT03422289|Dietary Supplement|myo-inositol plus folic acid|this treatment is made in the first phase of the study for three months
15929650|NCT03422289|Dietary Supplement|myo-inositol plus folic acid plus alpha-lactalbumin|this treatment is made in the second phase of the study and it has a new molecule added to the previous ones administered in the first phase of the study
15929651|NCT03422276|Other|Rehabilitation Discharge Plan|"CARF standards for discharge following an inpatient rehabilitation stay for a traumatic brain injury. This approach may include the following:
~patient and family education about TBI, both general and individualized to each person's symptoms and level of function, as well as education on medications and symptoms to monitor following discharge;
~written discharge care instructions, including recommended appointments with primary care, rehabilitation medicine and outpatient therapies, and medication list which are reviewed with the patient and family prior to discharge; and
~a phone call from an inpatient care provider within a few days of discharge to address any immediate problems and ensure that equipment has arrived, medications are being taken, etc."
15929652|NCT03422276|Other|Rehabilitation Transition Plan|"Participants and their caregivers (if applicable) randomized to the Rehabilitation Transition Plan group will receive up to 12 scheduled contacts 6 months post-discharge from a TBI care manager familiar with the care and resource networks at the respective sites. The contacts will at minimum be by telephone, although a HIPAA-compliant video conferencing option will also be available.
~The content of these contacts will include:
~Particularly in the first few calls, review of discharge plans and assistance and/or directive problem-solving around any obstacles to following discharge plans;
~Assessment of unmet needs, developed into a standard checklist of areas of need that are relevant to TBI, culled from literature on need fulfillment in this population."
15929653|NCT03422250|Device|transcranial direct current stimulation (tDCS)|10 daily 25-minutes tDCS sessions over two weeks.
15929654|NCT03422237|Biological|RSV ΔNS2/Δ1313/I1314L|10^6 plaque-forming units (PFU); administered as nose drops
15929655|NCT03422237|Biological|RSV 276|10^5 PFU; administered as nose drops
15929656|NCT03422237|Biological|Placebo|Administered as nose drops
15929657|NCT03422224|Diagnostic Test|Mixed lymphocyte reaction|Assessment of alloreactive T cell repertoire
15929658|NCT03422211|Other|Questionnaire|Will ask patients questions in regards to how many narcotics they have taken and what their pain level has been.
15929659|NCT03422198|Radiation|Vaginal Cuff Brachytherapy|Undergo standard of care vaginal cuff brachytherapy
15929660|NCT03422198|Radiation|Short course vaginal cuff brachytherapy|Undergo short course vaginal cuff brachytherapy
15929661|NCT03422185|Other|No intervention|No intervention
15929662|NCT03422172|Drug|Oral CAB|CAB tablet will be formulated as white to almost white, oval shaped, film coated 30 mg tablets, administered orally once daily. The CAB tablets will be packaged in bottles containing 30 tablets each.
15929663|NCT03422172|Drug|CAB LA|CAB LA is a sterile white to slightly colored suspension containing 200 mg/mL of CAB as free acid for administration by IM injection in gluteus medius.
15929664|NCT03422159|Drug|Ascorbic Acid|Ascorbic Acid 1.5g IV piggyback every 6 hours for 4 days (or discharge from ICU if prior to 4 days).
15929665|NCT03422159|Drug|Thiamine|Thiamine 200mg IV piggyback every 12 hours for 4 days (or discharge from ICU if prior to 4 days).
15929666|NCT03422159|Drug|Hydrocortisone|Hydrocortisone 50mg IV push every 6 hours for 4 days (or discharge from ICU if prior to 4 days).
15929667|NCT03422159|Drug|Sodium Chloride 0.9%|"Placebo Ascorbic Acid 100mL IV piggyback every 6 hours, Placebo Thiamine 50mL IV piggyback every 12 hours, and Placebo Hydrocortisone IV push every 6 hours for 4 days (or discharge from ICU if prior to 4 days)."
15929668|NCT03422146|Other|Tea Tree Oil (TTO)|Participants will use the Cliradex® eyelid hygiene lid wipe / towelette for BID for 2 weeks
15929669|NCT03422146|Other|I-Lid'n Lash® Hygiene|Patients will use the I-Lid'n Lash® Hygiene lid wipe / towelette for BID for 2 weeks
15929698|NCT03421860|Drug|"cardiac output changes with phenylephrine"|measure cardiac output after giving a bolus of phenylephrine intervention: will receive complementary doses of ephedrine to maintain systolic blood pressure above 80 % of baseline
15929699|NCT03421860|Drug|"cardiac output changes with ondansetron"|measure cardiac output after giving a bolus of ondansetron intervention: will receive complementary doses of ephedrine to maintain systolic blood pressure above 80 % of baseline
15929670|NCT03422133|Other|Patient-oriented, personalized risk communication eHealth application|The application features simple and consistent design, large well-lit buttons that tolerate tremor, and simple language. The process will be applied in preoperative clinics at The Ottawa Hospital (TOH), where patients will be asked to provide their personal health history through a series of questions already used on our TOH preoperative health screener. These values will then populate the NSQIP Universal Risk Calculator, which we have calibrated to TOH data, to generate personalized risks of mortality, serious complications, and hospital length of stay. These risk estimates will be communicated directly to the patient using absolute risk estimates represented pictorially (best practice for risk communication to patients). Risk estimates will also be provided to the patient's clinician.
15929671|NCT03422120|Other|Natural Killer Cell Activity Assay|Subjects had a blood test to measure NK cell activity (NKA) at different time points
15929677|NCT03422081|Diagnostic Test|arterial doppler ultrasound|doppler ultrasound
15929678|NCT03422068|Drug|BI 1015550|Tablet formulation
15929679|NCT03422068|Drug|Placebo|Tablet formulation
15929680|NCT03422055|Drug|99mTc-Fucoidan SPECT|Intravenous administration of 99mTc-Fucoidan on healthy volunteers.
15929681|NCT03422042|Other|Short duration of antibiotic|Patient will received intravenous antibiotic until the body temperature is less than 37.8 c fir 72, then antibiotic is discontinued.
15929682|NCT03422042|Other|Standard treatment of antibiotic|Patient will received intravenous antibiotic for 7 days, followed by oral antibiotic for 7 days, regardless of the body temperature.
15929683|NCT03422029|Drug|177Lu-Dotatate PRRT|"PRRT using 177Lu-Dotatate 100-150mCi will be performed 8-weekly. A maximum of 8 cycles will be administered.
~Other: Amino-Acid Solution The Amino-Acid Solution (AAS) to be used in this study, infused over 4-6 h, starting 30 min before PRRT"
15929684|NCT03422016|Diagnostic Test|electroretinogram (ERG)|an ERG is a measure of the eyes response to a flash of light
15929685|NCT03422003|Radiation|Radiation Therapy|"For the conventional fractionation arm: Each fraction will consist of 200 cGy per day. Total dose = 5000 cGy to the chest wall and 4600-5000 cGy to the lymph nodes.
~For the hypofractionation arm: Each fraction consists of 266 cGy per day. Total dose = 4256 cGy to the chest wall and 3990 cGy to the lymph nodes."
15929686|NCT03421990|Procedure|General anesthesia|general anesthesia and regional anesthesia techniques are used
15929687|NCT03421977|Biological|Onasemnogene Abeparvovec-xioi|Patients received treatment with onasemnogene abeparvovec-xioi in the parent study, AVXS-101-CL-101
15929688|NCT03421964|Behavioral|Resilience/Adjustment Counseling|The Resilience and Adjustment Intervention (RAI) consists of seven 60-minute sessions scheduled over seven weeks. Before the first session, participants will be mailed an empty loose-leaf binder to store and organize completed self-assessments, reading materials, and homework assignments from each session. They will be asked to review materials and complete worksheets between sessions. The RAI will be implemented by experienced, licensed therapists.
15929689|NCT03421964|Behavioral|Resilience/Adjustment Counseling with Booster Sessions|"The Resilience and Adjustment Intervention (RAI) consists of seven 60-minute sessions scheduled over seven weeks. Before the first session, participants will be mailed an empty loose-leaf binder to store and organize completed self-assessments, reading materials, and homework assignments from each session. They will be asked to review materials and complete worksheets between sessions.
~For the RAI+ participants, three booster sessions will be implemented. The three weekly booster sessions will be scheduled to start three months following completion of Session 7 of the RAI. The program will be implemented by experienced, licensed therapists."
15929690|NCT03421938|Other|Walking Exercise|Group 1 will have downhill walking exercises with %10 slope; group 2 uphill walking exercises on the treadmill with %10 slope..
15929691|NCT03421925|Procedure|Laparoscopic totally extraperitoneal procedure for inguinal hernia|Laparoscopic totally extraperitoneal procedure for inguinal hernia is a technique that is done by not entering the peritoneal cavity
15929692|NCT03421912|Other|Cicaplast Balm B5|The patients have to do 2 to 3 applications per day on the face, on lesions and in poultice in the evening in case of painful crack on the fingers
15929693|NCT03421912|Other|Dexeryl|The patients have to do 2 to 3 applications per day on the face, on lesions and in poultice in the evening in case of painful crack on the fingers
15929694|NCT03421886|Device|Aerodentis system|The Aerodentis system is intended for the treatment of tooth malocclusion and is treated by applying force, over time, to teeth requiring alignment. It is an individually-fitted, plastic dental mouthpiece that is inserted and worn by the patient according to the dental practitioner's treatment plan. The Aerodentis system is comprised of a plastic mouthpiece containing an inflatable balloon that provides pressure (force) on the selected teeth designated to be moved to a final treated state. The inflatable balloon is inflated to the desired pressure using an electrical air pump unit that is programmed by the dental practitioner using Dror Orthodesign proprietary software; thus creating a course treatment specially designed for each patient.
15929695|NCT03421886|Device|Invisalign clear aligner system|Clear aligners are used for the treatment of tooth malocclusion. In these devices, a series of mouthpieces are used, where the force created by each mouthpiece on the treated teeth is designed to push the teeth in small, one step increments, toward the desired result.
15929696|NCT03421873|Other|0h/1h hs-cTnT protocol|Implementation of a 0h/1h hs-cTnT protocol in routine care
15929697|NCT03421860|Drug|"cardiac output changes with ephedrine"|measure cardiac output after giving a bolus of ephedrine intervention: will receive complementary doses of ephedrine to maintain systolic blood pressure above 80 % of baseline
15929769|NCT03421288|Drug|5-Fluorouracil|Day 1 q2w: 2600 mg/m² IV over 24 hours
15929700|NCT03421860|Drug|"cardiac output changes with nor-epinephrine"|measure cardiac output after giving a bolus of nor-epinephrine intervention: will receive complementary doses of ephedrine to maintain systolic blood pressure above 80 % of baseline
15929701|NCT03421847|Diagnostic Test|Rotatory vestibular test|We will measure Depression and Healthy subjects vestibular activity by Rotatory Vestibular tests
15929702|NCT03421834|Procedure|Catheter ablation of ventricular tachycardia|Catheter ablation with a uniform mapping system, procedural endpoint, and definition of acute procedural success.
15929703|NCT03421834|Drug|Optimal medical treatment|Optimal guidelines-based heart failure treatment and antiarrhythmic drugs. Antiarrhythmics will be avoided if possible in the ablation group.
15929704|NCT03421821|Drug|Ropivacaine|Subfascial injection OR extrafascial injection
15929705|NCT03421808|Device|Transcranial Magnetic Stimulation (TMS)|TMS
15929706|NCT03421795|Other|Let's Talk About Pain Training|See arm/group descriptions.
15929707|NCT03421795|Other|Family Centered Care Training|See arm/group descriptions.
15929708|NCT03421782|Behavioral|Cognitive Behavior Therapy|Undergo PROSPECT internet-based CBT
15929709|NCT03421782|Behavioral|Exercise Intervention|Undergo POWER exercise intervention
15929710|NCT03421769|Procedure|EA and AMLK|A 7-9mm diameter corneal epithelial tissue will be obtained from the fellow eye using femtosecond laser technology. This epithelial autograft (EA) is then ready for transplantation on the disease eye, following the procedure of allogeneic middle lamellar keratoplasty (AMLK).
15929711|NCT03421769|Procedure|LA and AMLK|A 3-clock-hour limbal autograft (LA) will be obtained from the fellow eye. This is then ready for transplantation on the disease eye following the procedure of AMLK.
15929712|NCT03421756|Drug|Alemtuzumab|Alemtuzumab is a non-myeloablative pre-transplant conditioning regimen. Non-myeloablative therapy uses doses of chemotherapy and radiation to weaken (but not destroy) the patients bone marrow and immune system, while still allowing their body will accept the donor's stem cells. Alemtuzumab will be given 7 days prior to stem cell infusion at 0.03 mg/kg IV, 6 days prior to stem cell infusion at 0.1 mg/kg IV, and 5 thru 3 days prior to stem cell infusion at 0.3 mg/kg IV.
15929713|NCT03421756|Radiation|Total Body Irradiation|300 cGy will be administered in a single fraction on Day - 2. TBI is used commonly as part of pre-transplant conditioning in a variety of settings.
15929714|NCT03421756|Drug|Sirolimus|Sirolimus will be used for the prevention of graft-verus-host disease and will begin on Day - 1.
15929715|NCT03421743|Drug|Inhaled molgramostim|300 µg / dose molgramostim (recombinant human GM-CSF) for inhalation
15929716|NCT03421730|Combination Product|VR647 Inhalation Suspension (budesonide) 1 mg/2 mL delivered by the VR647 Inhalation System|The VR647 Inhalation System consists of the VR647 Inhalation System 1 control unit, a VR647 nebulizer handset, a mouthpiece and VR647 Smart Cards designed specifically for this trial.
15929717|NCT03421730|Combination Product|1 mg/2 mL Pulmicort Respules delivered by a conventional jet nebulizer|Commercial Pulmicort Respules (budesonide inhalation suspension 1 mg/2 mL) delivered by a conventional jet nebulizer operated to sputtering.
15929718|NCT03421717|Device|Chitosan brush|If inflammation (Bleeding on probing) and deep pockets (4 mm or more) is present at the control - maintenance is performed according to allocation
15929719|NCT03421704|Device|DreamStation BiPAP autoSV|Philips Respironics DreamStation BiPAP autoSV (PR DS-autoSV) is designed to deliver pressure support for patient ventilatory assistance
15929720|NCT03421691|Device|excel V Laser|excel V Laser Genesis procedure utilizing 1064 nm Nd:YAG laser
15929721|NCT03421678|Diagnostic Test|Urine Sample|One to two home visits where tobacco use and medical history and biological samples will be collected including blood, buccal cells and urine
15929722|NCT03421665|Device|Titan 3D Wedge System|Each subject will undergo an LCL procedure and/or medial cuneiform osteotomy with one or more TITAN 3-D™ Wedges. Ancillary fixation should be used in conjunction with each TITAN 3-D™ Wedge used. This surgical procedure will be performed as standard of care and is not part of the research procedures. Post-operative care and weight-bearing/activity restrictions will be at the discretion of the surgeon as part of their standard of care for the procedure.
15929723|NCT03421652|Drug|Nivolumab|Patients receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 14 days (2 weeks) for up to 14 courses (6 months) in the absence of disease progression or unacceptable toxicity. Beginning 3 days of course 1, patients undergo radiation therapy over 32-35 on weeks 1, 3, 5, 7 and 9.
15929724|NCT03421652|Radiation|Radiation|Beginning 3 days of course 1, patients undergo radiation therapy over 32-35 on weeks 1, 3, 5, 7 and 9.
15929725|NCT03421639|Drug|Ulipristal acetate|5.0mg/day of Ulipristal acetate for 3 months
15929726|NCT03421639|Drug|Aromatase inhibitor plus GnRH analog|1mg/day of Anastrazole plus 3.6mg/monthly for 3 months
15929727|NCT03421626|Device|Xpert BCR-ABL Ultra|Semi-quantitation of BCR-ABL transcript in patients that have been previously diagnosed with CML
15929728|NCT03421613|Drug|3VM1001|Self treatment 3 times daily for 10 days
15929729|NCT03421613|Other|Placebo|Cream without investigational drug. Self treatment 3 times daily for 10 days
15929730|NCT03421600|Device|blue laser imaging|blue laser imaging
15929731|NCT03421600|Device|White light imaging|White light imaging
15929732|NCT03421587|Behavioral|Processing of social olfactory and tactile stimuli|Processing of social olfactory and tactile stimuli in trauma-exposed individuals and controls is examined using functional magnetic resonance imaging.
15929733|NCT03421574|Device|MR-guided Focused Ultrasound|Focused Ultrasound allows for non-invasive thermal ablation of soft tissue virtually anywhere in the body. Treatment begins by acquiring a series of magnetic resonance (MR) images of the target tissue. The physician then reviews the images on the system workstation, identifies the target, delineates treatment contours, and reviews the treatment plan. Therapy planning software calculates the parameters required to effectively treat (e.g. ablate) the defined region. During treatment, the patient wears a helmet equipped with multiple sources of ultrasound which generate a point of focused energy, called a sonication. The sonication raises the tissue temperature within a well-defined region, causing a thermal coagulation effect.
15929734|NCT03421561|Device|"Stellarex 0.035 OTW Drug-coated Angioplasty Balloon"|"The Stellarex 0.035 OTW Drug-coated Angioplasty Balloon is indicated for percutaneous transluminal angioplasty (PTA), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm."
15929735|NCT03421561|Device|EverCross™ 0.035 PTA Balloon Catheter|The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Medtronic, Plymouth, MN 55441, USA).
15929736|NCT03421548|Device|EyeMate|Patients will undergo implantation BKPro with concomitant implantation of the EyeMate pressure sensor. The surgical approach will involve a trephination of the central recipient cornea of adequate size. In subjects with adequate capsular support, the sensor device will be placed in the sulcus space by grasping the sensor's silicone sleeve at approximately the 3 and 9 o'clock positions and sliding it into the sulcus space. In subjects in whom capsular support is inadequate, the Eyemate implant will be sutured to the sclera. This is performed by placing an 8-O Gortex suture or 9-O prolene on CIF-4 needles around the antenna at the 2 and 7 o'clock positions and suturing the device to the sclera using an ab-interno technique.
15929737|NCT03421535|Procedure|Sleeper Stretch|Internal Range of motion of dominant shoulder
15929738|NCT03421535|Procedure|Opposite SI joint Stretch|Internal range of motion of dominant shoulder
15929739|NCT03421522|Other|ICBN preservation surgery|"For participants randomized to the ICBN preserving technique, surgeons will perform axillary dissection in which the second ICBN, just inferior to the axillary vein, will be preserved. Surgeons will be asked to indicate whether the ICBN nerve was fully preserved, partially preserved, or sacrificed.
~All study participants will receive anesthetic management at the discretion of the attending physician, which will be documented."
15929740|NCT03421509|Other|cutaneous silent period|In the upper limb the cutaneous silent period (CSP) is a brief transient suppression of the voluntary muscle contraction that follows painful stimulation applied to the finger (digits II-V, C6-C8 dermatomes)
15929741|NCT03421496|Drug|Cannabidiol Oral Solution|An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
15929742|NCT03421496|Drug|Placebo|Matching oral solution
15929743|NCT03421496|Drug|Vigabatrin|Powder suspension
15929744|NCT03421483|Dietary Supplement|Folic Acid supplementation|Participants receive a 400 microgram Folic Acid supplement
15929745|NCT03421483|Dietary Supplement|Adult Multivitamin|Participants will receive an adult multivitamin supplement
15929746|NCT03421457|Procedure|Uterus-preserving laparoscopic lateral suspension with mesh|V-shaped 2cm wide and 25cm length mesh strip is prepared from a 30x30cm Prolene mesh (Ethicon J&J).Deep dissection of the uterovesical space is performed.Cutaneous incisions are bilaterally made 3-4 cm superoposterior to the anterosuperior iliac spine.A grasper is introduced retroperitoneally through the sub-peritoneum holding the beginning part of mesh until reaching the vesicovaginal space in an oblique route rather than transverse.Round ligament is lifted upward and tunnel is practiced horizontally.Assistant grasper catches the distal mesh and pulls out through the opposite subperitoneal tunnel.Corner of mesh is fixed to the pubocervical fascia,uterine cervix and isthmus with Absorba-Tack™(Covidien, Mansfield,USA).Tension-free lateral mesh suspension is achieved at the desired level.
15929747|NCT03421457|Procedure|Uterus-preserving laparoscopic sacrocervicopexy with mesh|The peritoneum over the sacral promontory is incised until the anterior longitudinal ligament is reached and ureters are identified. Peritoneal relaxing incision is made medial to the right ureter, down into the pelvis, posterior to the cervix and rectovaginal fascia, laterally to the rectum. The arm of the mesh is sutured to the posterior cervix by 2.0 prolene and fixated to the sacral promontory by either Tacker (Covidien) and/or 2.0 prolene as tension-free. Complete peritonisation of the mesh is performed.
15929748|NCT03421444|Other|No intervention|No intervention
15929749|NCT03421431|Drug|EDP-305 Dose 1|Two tablets daily for 12 weeks
15929750|NCT03421431|Drug|EDP-305 Dose 2|Two tablets daily for 12 weeks
15929751|NCT03421431|Drug|Placebo|Two tablets daily for 12 weeks
15929752|NCT03421405|Device|NeuroCatch Platform™|NeuroCatch Platform™ consists of software and hardware that captures brain health information. The platform intends to provide a quick, portable and easy to use solution for the acquisition, display, analysis, storage, reporting and management of electroencephalograph (EEG) and event-related potential (ERP) information.
15929753|NCT03421392|Other|non interventional study|non interventional study
15929754|NCT03421379|Drug|Glucagon Nasal Powder|Administered intranasally
15929755|NCT03421379|Drug|Glucagon Hydrochloride Solution|Administered IM
15929756|NCT03421366|Drug|Posaconazole|A triazole antifungal drug that is used to treat invasive infections by Candida species and Aspergillus species in severely immunocompromised patients
15929764|NCT03421340|Device|DSC|Stone removal without fluoroscopy using the SpyGlass device.
15929765|NCT03421340|Device|ERC|Standard of care stone removal with fluoroscopy.
15929766|NCT03421314|Dietary Supplement|Zinc gluconate and/or Selenium yeast|30 mg dose of zinc gluconate and/or 200 mcg of selenium yeast
15929767|NCT03421301|Dietary Supplement|dietary portfolio|The dietary intervention was a combination of functional foods (dehydrated nopal, chia seed, soy protein and inulin) that was provided in dehydrated form in packages of 17.3 g dissolved in 250 ml water for breakfast and 34.7 g in 300 ml water for dinner.
15929768|NCT03421288|Drug|Atezolizumab|Day 1 q2w: 840 mg IV over 1 hour (4 cycles perioperative with FLOT) + Day 1 q3w: 1200 mg IV over 1 hour (8 additional cycles monotherapy)
15929770|NCT03421288|Drug|Calciumfolinat|Day 1 q2w: 200 mg/m² IV over 1 hour
15929771|NCT03421288|Drug|Oxaliplatin|Day 1 q2w: 85 mg/m² IV over 2 hours
15929772|NCT03421288|Drug|Docetaxel|Day 1 q2w: 50 mg/m² IV over 1 hour
15929773|NCT03421275|Drug|Esketamine|anesthetic used as analgetic in subanesthetic doses given intranasally
15929774|NCT03421275|Drug|Fentanyl Citrate|intravenous fentanyl given intranasally
15929775|NCT03421275|Drug|Saline Nasal|intravenous saline given intranasally as placebo
15929776|NCT03421262|Diagnostic Test|IADPSG Criteria|One-step: 2 hr 75 gr OGTT
15929777|NCT03421262|Diagnostic Test|NDDG Criteria|Osullivan test + 3 h 100 g OGTT
15929778|NCT03421249|Other|Exercises|Muscle strengthening exercises of the hip and knee muscles
15929779|NCT03421249|Other|Electromagnetic field therapy|Electromagnetic field therapy with Magnetron®
15929780|NCT03421236|Biological|Ty21a|intravesical administration of Ty21a
15929781|NCT03421223|Other|No intervention|No intervention
15929782|NCT03421210|Drug|Nicotine patch|Participants will wear nicotine patches for 10 weeks after their quit date. 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment.
15929783|NCT03421197|Drug|PPC-06 400 mg QD|Tepilamide Fumarate 400 mg tablet once per day
15929784|NCT03421197|Drug|PPC-06 400 mg BID|Tepilamide Fumarate tablets 400 mg twice per day
15929785|NCT03421197|Drug|PPC-06 600 mg|Tepilamide Fumarate tablets 600 mg twice per day
15929786|NCT03421197|Drug|Placebo|white tablet with no active ingredient manufactured to mimic Tepilamide Fumarate tablets
15929787|NCT03421184|Other|blood sample|25 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
15929788|NCT03421184|Other|urine sample|10 ml
15929789|NCT03421184|Other|food questionnaire|dietary habit enquiry and a 48h dietary
15929790|NCT03421184|Other|hair|lock of hair
15929791|NCT03421171|Other|no intervention|Qualitative research through semi-structured interviews
15929792|NCT03421158|Behavioral|breastfeeding|Newborns were breastfed during the procedure
15929793|NCT03421158|Dietary Supplement|oral sucrose|Newborns were given oral sucrose during the procedure
15929794|NCT03421158|Behavioral|Skin-to-Skin contact|Newborns were placed in direct contact with their mothers during the procedure
15929795|NCT03421158|Behavioral|Non-nutritive sucking|newborns were given a pacifier to suck on during the procedure
15929796|NCT03421119|Drug|Liraglutide 6 MG/ML Pen Injector|Patients in each arm will receive either CinnaGen-liraglutide or Victoza®. Both products will be provided as pen-injector.
15929797|NCT03421119|Drug|Metformin|Patients who were receiving metformin with maximum tolerable dose prior to study will continue to receive it during the study.
15929798|NCT03421119|Drug|Sulfonylurea/non-sulfonylurea insulin secretagogues|Patients who were receiving Sulfonylurea/non-sulfonylurea insulin secretagogues with maximum tolerable dose prior to study will continue to receive it during the study.
15929799|NCT03421106|Behavioral|Intervention Food Pantries|Food pantries will receive consulting services to transform their food offerings and environment in order to influence client health behaviors.
15929800|NCT03421106|Other|Control Food Pantries|Normal food pantry use
15929801|NCT03421093|Procedure|Surgeries|Surgeries or surgeries plus adjuvant therapies
15929802|NCT03421080|Behavioral|MoodGYM|The MoodGYM Internet intervention will employ the latest version of MoodGYM (Mark 4) which has been updated to support mobile devices. The core design and function of the program has not been altered. A major focus of this intervention is to provide individuals with behavioral and cognitive strategies to improve depression symptoms.
15929803|NCT03421080|Behavioral|Check Your Drinking|Internet intervention designed to assess and provide feedback on hazardous alcohol use. The CYD has been subjected to seven randomized trials from two independent research groups, all of which displayed a significant impact of the CYD to reduce hazardous alcohol consumption compared to controls.
15929804|NCT03421054|Dietary Supplement|patients assuming nutraceutical containing HA|pain reduction of the affected knee in the patients assuming nutraceutical containing HA
15929805|NCT03421041|Drug|Dexamethasone Oral Tablet|Dexamethasone Oral Tablet，0.75mg/tablet
15929806|NCT03421028|Device|Electromyography Biofeedback|EMG-Biofeedback- assisted training is a method in which electrodes situated on the surface of the skin detect small voltage changes which arise from the working muscles (in this case masseter and temporalis muscles). The voltage is transformed into a visual or sound time-variable signal which gives the patient feedback as he willingly tries to change the muscle tension (in this case to lower the excessive masseter tension)
15929807|NCT03421028|Other|Classic treatment for myogenous TMD|Combination of physiotherapy (manual therapy), stabilization occlusal splint usage and counseling
15929808|NCT03421002|Drug|Micafungin|Participants will receive micafungin 8 mg/kg per day via intravenous infusion for approximately 1 hour.
15929809|NCT03420989|Other|Active snack food|snack enriched with seaweeds and carob
15929810|NCT03420989|Other|Control snack food|the same snack food without seaweeds and carob
15929811|NCT03420976|Dietary Supplement|Novel Supplement Based Therapy|"Supplements and Dosage:
~Detox Support: Liver-G.I. Detox BID for 30 days GI Support: L-Glutamine Powder 2 scoops QD for 35 days Microbial Balance: MicroDefense 1 capsule QD for 49 days Microbial Balance: A.C. Formula II 2 capsules BID for 49 days Probiotic: Probiotic-5 1 capsule QD for 49 days Digestive Enzymes: Digestive Enzymes Ultra with Betaine HCl As needed up to 6 longer term"
15929812|NCT03420963|Biological|Cord Blood-derived Expanded Allogeneic Natural Killer Cells|Given IV
15929813|NCT03420963|Drug|Cyclophosphamide|Given IV
15929814|NCT03420963|Drug|Etoposide|Given IV
15929815|NCT03420950|Other|Rapid sequence intubation: sedative first|Sedative first
15929816|NCT03420950|Other|Rapid sequence intubation: paralytic first|Paralytic first
15929817|NCT03420937|Drug|Sugammadex|Deep neuromuscular block provided by rocuronium to PTC 1-2. Reversal of the block with sugammadex.
15929818|NCT03420937|Drug|Neostigmine, Atropin Biotika|Standard neuromuscular block provided by rocuronium to TOF-count 1-2. Reversal of the block with neostigmine.
15929819|NCT03420924|Device|Thermal suit|Forced-air warming device will be connected to the trouser legs of the thermal suit.
15929849|NCT03420664|Device|Orthosis VACOped|Orthosis for lower limb immobilisation
15929820|NCT03420924|Device|Conventional hospital clothes|The warming mattress and a forced-air warming blanket for the lower body will be used intraoperatively.
15929821|NCT03420911|Drug|dexketoprofen trometamol|
15929822|NCT03420911|Drug|Midazolam|
15929823|NCT03420898|Other|Quality Improvement Intervention, prescription reduction|The intervention is a quality improvement education aimed at reducing sedative prescriptions and implementing safe sleep environments.
15929824|NCT03420885|Behavioral|Ba Duan Jin|Ba Duan Jin, a traditional Chinese health-preserving technique, combines the traditional Chinese medicine and traditional Chinese philosophy and embrace the body, breath and spirit. Ba Duan Jin consists of eight main movements. According to traditional theory, every movement has unique effect to different Zang-fu organs.
15929825|NCT03420885|Behavioral|Health Education|Health education includes work, rest, diet and other basic programs according to the different conditions of participants.
15929826|NCT03420872|Other|Nutrient mixtures|consumption of a mixture of beneficial nutrients
15929827|NCT03420859|Diagnostic Test|qPCR for abnormal vaginal microbiota|qPCR for A.vaginae and/or G.vaginalis as developed in the pilot study (Hum Reprod. 2016 Apr;31(4):795-803. doi: 10.1093/humrep/dew026. Epub 2016 Feb 23.)
15929828|NCT03420846|Other|OCT Mapped|Presurgical mapping of Basal Cell Carcinoma margins
15929829|NCT03420833|Device|Cardiac resynchronization therapy pacemaker (CRT-P)|A pacemaker is an implantable, battery-powered minicomputer that sends electrical pulses to the heart whenever it detects a slow heartbeat or no heartbeat at all. When it senses a slow heartbeat or lack of heartbeat, it sends electrical impulses to restore a normal rhythm. Cardiac resynchronization therapy pacemakers, or CRT-Ps, treat heart failure by resynchronizing electrical impulses in the heart's four chambers, improving the heart's ability to pump blood to the body effectively and efficiently.
15929830|NCT03420820|Biological|Bacterial Culture Swab|Culture swabs will be obtained before application of PI and after injection.
15929831|NCT03420807|Device|MHRC|Evaluate the feasibility of detection of beta-amyloid plaques by using their spectral signature in autofluorescence or reflectance.
15929832|NCT03420794|Other|Timing of pre-operative oral non-narcotic analgesics in relation to minimally invasive hysterectomy|Patients will be screened, enrolled, consented, and randomized during the preoperative office encounter, typically occurring within the 30 days prior to surgery. Patients randomized to pre-admission administration (study group) will be provided with a prescription for a one-time dosing of routine oral non-narcotic analgesic medications to be filled at the Cleveland Clinic outpatient pharmacy. Both the study and the control groups will receive written pre-operative instructions. Those patients randomized to the standard practice of administration in the pre-anesthesia unit (control group) will be administered the same medications in the same doses by the nursing staff. Patients in both groups will undergo general anesthesia, orogastric tube placement, and minimally invasive hysterectomy (MIH). Postoperatively, these patients will be observed for differences in PACU narcotic uptake, pain scores, patient satisfaction, and surgical recovery.
15929833|NCT03420781|Drug|Relamorelin|Relamorelin 10 μg injected twice daily for 6, 40 or 46 weeks.
15929834|NCT03420781|Drug|Placebo|Placebo injected twice daily for 6 weeks or 40 weeks.
15929835|NCT03420768|Drug|BMS-986263|Administered by intravenous (IV) infusion
15929836|NCT03420768|Other|Placebo|Administered by intravenous (IV) infusion
15929837|NCT03420755|Behavioral|Mothers and Babies 1-on-1|MB 1-on-1 is a 12-session intervention divided into five modules. An introductory 2-session module establishes key concepts related to stress, monitoring of one's mood, and ways in which one's mood influences one's internal thoughts and external environment; three 3-session modules correspond with key cognitive-behavioral elements: pleasant activities, thoughts, and social support/contact with others; a 1-session summary reviews content and identifies areas for future use of MB skills. Throughout MB, mood management skills are integrated using psycho-educational activities that encourage participants to understand connections between their mood and their activities, thoughts, and contacts with others.
15929838|NCT03420755|Behavioral|Mothers and Babies Plus Text|MB 1-on-1 along with text enhancements, both in English and Spanish. These texts focus on: a) skill reinforcement (e.g., Some thoughts just come to us, but we can make a conscious effort to think of positive thoughts.); b) homework reminders (e.g., What pleasant activity will you try today?), and c) self-monitoring (e.g., On a scale of 1-9, how would you rate your mood?). These texts will be linked with the 12 MB sessions. Specifically, after completing each in-person session, 3 texts will be sent by a home visitor to her client; one text will focus on skill reinforcement, one will be a homework reminder, and one will focus on self-monitoring.
15929839|NCT03420742|Drug|Midazolam|Midazolam syrup.
15929840|NCT03420742|Drug|Brigatinib|Brigatinib tablets.
15929841|NCT03420729|Procedure|gastroscopy|a thin, flexible tube called an end oscope is used to look inside the oesophagus (gullet), stomach and first part of the small intestine (duodenum)
15929842|NCT03420729|Device|magnetic assisted capsule endoscopy|The patient will be given 500 to 1000mls of water with 6 drops of simethicone added to drink. This is to enable adequate distension of the stomach. The patient then swallows the capsule in the presence of the PI. MACE of the oesophagus and stomach will be carried out by the PI. Once the PI is satisfied that an adequate examination has been completed the capsule will be allowed to pass into and through the small bowel.
15929843|NCT03420716|Dietary Supplement|yogurt|
15929844|NCT03420703|Other|erector spinae plane block|ultrasound guided erector spinae plane block will be administered to this group.
15929845|NCT03420703|Device|Intravenous morphine patient controlled analgesia device|Intravenous morphine patient controlled analgesia device will be given to the patients postoperatively and 24 hour morphine consumption will be recorded
15929846|NCT03420690|Other|satisfaction questionnaire after art therapy session|After the administration of art therapy sessions (>1) and the death of patients (> 1 month), the intervention consists in submitting to families of patients a satisfaction questionnaire intended to evaluate the impact of art therapy session and in particular about their relationships.
15929847|NCT03420677|Device|Application of tones|During NREM sleep, tones (max. 60 dB) will be played using a portable, safe, in-home device. This device records biosignals (e.g. brain activity) and precisely times the tones during NREM sleep. It was developed and produced by the ETH Zurich and approved for use in this study by Swissmedic
15929848|NCT03420677|Device|No application of tones|This is the sham-control intervention; The device will only record biosignals but will not play tones.
15929850|NCT03420664|Device|Below knee cast|Below knee cast for lower limb immobilisation
15929851|NCT03420651|Other|Peak Expiratory Flow Rate (PEFR)|PEFR values and the National Asthma Prevention and Education Program guidelines will be used by providers in the management of these patients.
15929852|NCT03420651|Other|Standard Clinical Judgement|Providers will use physical exam and standard clinical judgement to guide management.
15929853|NCT03420638|Drug|Adjunct Exparel (bupivacaine liposome suspension 1.3%)|After removal of the tonsils and before extubation, the principal investigator will infiltrate 0.5 mL of the standard of care medication-bupivacaine HCl 0.25% (2.5 mg/mL) with epinephrine (5 mcg/mL) i.m.-into the upper and lower poles of the anterior and posterior tonsillar pillars on the right and left side of the oropharynx for a volume of 2 mL of bupivacaine HCl on each side. Following the standard medication, the principal investigator will infiltrate 0.5 mL of adjunct Exparel (bupivacaine liposome suspension 1.3% [13.3 mg/mL] i.m.) into the upper and lower poles of the anterior and posterior tonsillar pillars on the right and left side of the oropharynx for a volume of 2 mL of bupivacaine liposome injectable suspension 1.3% (13.3 mg/mL) on each side.
15929854|NCT03420638|Other|Standard Care|After removal of the tonsils and before extubation, the principal investigator will infiltrate 0.5 mL of the standard of care medication-bupivacaine HCl 0.25% (2.5 mg/ mL) with epinephrine (5 mcg/mL) i.m.-into the upper and lower poles of the anterior and posterior tonsillar pillars on the right and left side of the oropharynx for a volume of 2 mL of bupivacaine HCl on each side.
15929855|NCT03420625|Device|Foot IPC|Intermittent pneumatic compression in the foot using the A-V Impulse™, Covidien®, New Haven, CT, USA
15929856|NCT03420625|Device|Rapid calf IPC|Intermittent pneumatic compression in the calf using the VenaFlow® Elite, DJO Global, USA
15929857|NCT03420625|Device|Slow calf IPC|Intermittent pneumatic compression in the calf using the Kendall SCD™ 700, Covidien, Medtronic, USA
15929858|NCT03420625|Device|Calf NMES|Neuromuscular electrical stimulation in the calf using the DJOTM, CefarCompex Mi-Theta 500 stimulator
15929859|NCT03420599|Procedure|splenectomy|Traumatic patients who performed total splenectomy
15929860|NCT03420586|Drug|Nitrous Oxide|The nitrous oxide group (GN2O) will receive 70% N2O in 30% O2 at the end of surgery.
15929861|NCT03420560|Behavioral|warmer temperature|Patients before general anesthesia induction will send to warmer operation Injection pain was accessed with (Visual analogous scale)VAS.
15929862|NCT03420547|Behavioral|RISE|Intervention will consist of 3 sessions over 6 weeks. Each session will last 2 hours and be conducted with a clinical psychologist or medical social worker. The intervention content include psycho-education, communication training between the couple, and exercises to foster intimacy. A therapy manual will be developed to ensure program delivery fidelity. A folder with session summaries will be provided to the participants.The intervention content include psycho-education, communication training between the couple, and exercises to foster intimacy. A therapy manual will be developed to ensure program delivery fidelity. A folder with session summaries will be provided to the participants.
15929863|NCT03420534|Drug|Iloperidone 1 MG|An open, random, two-period and two-sequence cross-test design was adopted for the fasting and postprandial groups, and the randomization method was adopted for each subject to randomly take the subjects or reference preparations.
15929864|NCT03420534|Drug|Placebo|An open, random, two-period and two-sequence cross-test design was adopted for the fasting and postprandial groups, and the randomization method was adopted for each subject to randomly take the subjects or reference preparations.
15929865|NCT03420534|Dietary Supplement|fasting|An open, random, two-period and two-sequence cross-test design was adopted for the fasting and postprandial groups, and the randomization method was adopted for each subject to randomly take the subjects or reference preparations.
15929866|NCT03420534|Dietary Supplement|postprandial|An open, random, two-period and two-sequence cross-test design was adopted for the fasting and postprandial groups, and the randomization method was adopted for each subject to randomly take the subjects or reference preparations.
15929867|NCT03420521|Drug|Nivolumab|240mg IV over 60 minutes Q2W
15929868|NCT03420521|Drug|Ipilimumab|1mg/kg IV over 30 minutes Q6W
15929869|NCT03420508|Drug|Ensartinib|Ensartinib will be given at a dose of 225mg daily in the form of 100mg and 25mg capsules. Patients will receive treatment continuously in 28 day cycles. Patients will then have the same tumor specimen biopsied again at day 15. Treatment will continue until disease progression, unacceptable toxicity, or patient choice to discontinue therapy.
15929870|NCT03420508|Diagnostic Test|ALKATI by Customized Nanostring Assay|a custom chip with probes targeting the ATI site in ALK, providing a reproducible, quantitative measure of ALKATI
15929871|NCT03420495|Behavioral|Decision-Making Tasks|All participants will receive a structured diagnostic assessment and complete self-report questionnaires about cognitive factors, decision-making styles, and anxiety/mood symptoms. They then will be guided through three judgment and decision-making (JDM) paradigms (the Risk and Ambiguity Task, the Beads Task, and the Balloon Analogue Risk Task), each of which each has been modified to differ by whether the likelihood of potential adverse outcomes is provided (or whether it remains ambiguous).
15929872|NCT03420482|Drug|Fecal Microbiota Transplant (FMT) oral capsules|Donors will be healthy individuals, selected through a previously published, rigorous screening process. Elizabeth Hohmann M.D. of MGH has demonstrated the safety and therapeutic efficacy of oral frozen FMT capsules in Clostridium difficile infection, and her lab will produce the capsules for this study.
15929873|NCT03420482|Drug|Placebo oral capsule|Oral placebo capsules filled with glycerol and cocoa powder. These capsules are identical in appearance to FMT capsules.
15929874|NCT03420469|Drug|Bupropion|Phase 1: Baseline CYP2D6 activity, using dextromethorphan (30 mg single dose PO) as a probe drug Phase 2: Single dose bupropion pharmacokinetics and its effect on CYP2D6 activity (determined by dextromethorphan 30 mg single dose PO) Phase 3: Steady state disposition of bupropion and its interaction with CYP2D6 activity (30 mg single dose PO)
15929875|NCT03420456|Device|Transcranial Light Therapy|Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions.
15929876|NCT03420443|Dietary Supplement|Oat bran|45 g oat bran.
15929877|NCT03420443|Dietary Supplement|Oat bran and blueberry husks|13 g freeze dried blueberry husks and 22 g oat bra + probiotic bacteria.
15929878|NCT03420443|Dietary Supplement|No oral supplementation|No oral supplementation.
15929879|NCT03420430|Biological|GL-ONC1|
15929880|NCT03420417|Device|Esophageal pressure measurement|Use of a nasogastric tube equipped with esophageal balloon to assess respiratory mechanics
15929881|NCT03420404|Other|TCM physician involved collaborative care model (TCMCMC)|"TCM physician delivered acupuncture as well as history taking, physical examination, non-pharmacological advice and communications with rheumatologists.
~Acupuncture procedures: After eliciting the deqi sensation, the needles will be left in place for 30 minutes. The acupuncture treatment will be done 2-3 times a week, with 5 sessions constituting a treatment course. There will be a break of 1 week in between each acupuncture course. Patients in the intervention arm will undergo 2 treatment courses (or 10 sessions) in total."
15929882|NCT03420391|Device|Photobiomodulation Therapy (PBMT)|Phototherapy device - Multi Radiance Medical® (Solon, OH, EUA)
15929883|NCT03420378|Dietary Supplement|vitamin D|Vitamin D replacement
15929884|NCT03420365|Behavioral|Aerobic exercise|30 minutes of either aerobic, or balance and coordination, or reading magazines
15929885|NCT03420352|Diagnostic Test|Thromboelastography|paired TEG analysis undertaken from participants with the two different needles
15929886|NCT03420339|Drug|Stimulant|The stimulants used must meet FDA dosage guidelines for age.
15929887|NCT03420326|Behavioral|Frailty status assessment|The Edmonton frail scale and Frailty criteria by Dr. Fried would be used to assess participants frailty status
15929888|NCT03420313|Drug|Buprenorphine/naloxone sublingual tablets|24-week maintenance with buprenorphine/naloxone sublingual tablets (plus other technology-assisted components described previously)
15929889|NCT03420300|Drug|EBR/GZR|Elbasvir/grazoprevir (EBR/GZR 50mg/100mg fixed dose combination [FDC]): 1 table per os per day for 12 weeks
15929890|NCT03420287|Combination Product|MPM Prepared From Allogenic Bone Graft|patients will receive a sticky bone which prepared by mixing the the growth factors of the patient with allogenic bone graft for cleft closure
15929891|NCT03420287|Other|Autogenous bone|patients will receive an autogenous bone graft from anterior iliac crest for cleft closure
15929892|NCT03420274|Behavioral|NEST|This is a point-of-care shared decision-making instrument.
15929893|NCT03420274|Behavioral|Usual care|This group will utilize usual care with respect to healthcare provider practice for education and counseling.
15929894|NCT03420261|Biological|0.9% saline|Fluid administration
15929895|NCT03420261|Biological|HES 130/0.4|Fluid administration
15929896|NCT03420248|Device|Non-spherical polyvinyl alcohol particle or Tris-acryl gelatin microsphere|One of non-spherical polyvinyl alcohol particle or tris-acryl gelatin microsphere is used for embolic materials. All other processes are same.
15929897|NCT03420235|Other|Home monitoring program|The home monitoring program consists of 1) the use of an interactive internet tool to coach patients and enhance self-management 2) home-based pulmonary function testing with a handheld spirometer and 3) recording of patient-reported outcomes (PROs).
15929898|NCT03420222|Drug|AVP-786|oral capsules
15929899|NCT03420222|Drug|Placebo|oral capsules
15929900|NCT03420209|Behavioral|Group applying PNF technique|
15929901|NCT03420196|Other|Supervised exercise program|"It will consist in a supervised exercise program, including the following exercises:
~Diaphragmatic breathing.
~Transverse abdomLateral leg raise for gluteus mediuminis muscle activation.
~Pelvic swing.
~Gluteus bridge.
~Spinal mobility.
~Spinal extensor muscles strengthening
~Frontal plank
~Side plank.
~Lateral leg raise for gluteus medium"
15929902|NCT03420196|Other|Non supervised exercise program|"It will consist in a non supervised exercise program, including the following exercises:
~Diaphragmatic breathing.
~Transverse abdomLateral leg raise for gluteus mediuminis muscle activation.
~Pelvic swing.
~Gluteus bridge.
~Spinal mobility.
~Spinal extensor muscles strengthening
~Frontal plank
~Side plank.
~Lateral leg raise for gluteus medium"
15929903|NCT03420170|Other|Graded Exercise Integrated Education|"Aerobic exercise Wheelchair propelling, boxing, hand cycling (2 rounds)
~3 mins. exercise and 2 mins. rest
~Increased to 4.5 mins. and 30 sec. rest
~Strengthening exercise:
~Vertical chest press, butterfly press; vertical row and wide lattissimus pull down 3 sets, 10 reps. and 2 min rest between sets, moderate to vigorous intensity (50% of 1 RM)
~Educational intervention:
~The educational intervention for exercise self-efficacy and physical activity level (2 hours a week for 8 weeks during in rehabilitation and once a month for 8 weeks after discharge from rehabilitation)"
15929904|NCT03420170|Other|Conventional Physical Therapy|Normal routine of physical therapy including mobility training, wheelchair skills, resistance exercise, aerobic training, balance exercise, functional exercise
15929905|NCT03420157|Other|Focus Group|Focus Group of 2 hours. Women will be asked to give their opinion about the communication media of the vaginal self-sampling kit.
15929906|NCT03420144|Drug|Standard Medical Therapy|Standard Medical Therapy will include nutritional support, rifaximin, lactulose, bowel wash, albumin, diuretics, multivitamins and antibiotics as required
15929907|NCT03420144|Drug|Growth Hormone|GH therapy is initiated at a low dose of 1U/day and titrated slowly upward to a maximum dose of 3U/day (depending on IGF-1 levels) subcutaneously for 1 year.
15929908|NCT03420131|Diagnostic Test|QFR and iFR|"iFR® (CE-Marked) is a pressure-derived, hyperemia-free index for the assessment of coronary stenosis relevance. This option consists of an FFR-iFR® specific patient interface module (PIM-FFR) which can be connected to the Volcano system - VOLCANO s5 or s5i™ platform equipped with iFR® option.
~QFR® (CE-Marked) is an angio-based FFR estimation using the analytical Software QAngio XA 3D from Medis medical imaging B.V., The Netherland"
15929909|NCT03420118|Procedure|Tumor tissue collection|"Depending on the status of disease when participants join the study, a sample of tumor tissue may be collected from:
~A previous surgery for the disease,
~A biopsy for diagnosing the disease,
~Other surgical procedures done for clinical management or possible cancer related complications (e.g., bowel obstruction).
~In addition:
~At anytime participants require a biopsy as a part of their cancer care, a sample of that tumor tissue will be collected.
~New biopsies will be done to collect fresh tumor tissue each time participants' disease worsens."
15929910|NCT03420118|Procedure|Blood draws|"Blood samples will be collected at the following different times points:
~Before starting a new line of treatment for the disease,
~One week after starting a new line of treatment for the disease,
~During treatment, at each radiological assessment (imaging scan) that will be done to check the status of the disease,
~At the time the disease worsens or relapses (comes back)
~During observation/follow-up, at the time of any radiological assessments that will be done to check the status of the disease"
15964126|NCT03157804|Procedure|Bone Marrow Aspiration|
15929911|NCT03420105|Other|Neuropsychological, psycho-pathological and quality of life assessments|Patients and Healthy volunteers perform neuropsychological, psycho-pathological and quality of life assessments, and sleep tests
15929912|NCT03420105|Drug|Hormonotherapy|Adjuvant hormone therapy
15929913|NCT03420092|Drug|Form 1 of AZD5718 tablets|The participants will be dosed with Form 1 of AZD5718 following an overnight fast of at least 10 hours.
15929914|NCT03420092|Drug|Form 2 of AZD5718 tablets|The participants will be dosed with Form 2 of AZD5718 following an overnight fast of at least 10 hours.
15929915|NCT03420092|Drug|Form 3 of AZD5718 tablets|The participants will be dosed with Form 3 of AZD5718 following an overnight fast of at least 10 hours.
15929916|NCT03420092|Drug|Form 4 of AZD5718 tablets|The participants will be dosed with Form 4 of AZD5718 following an overnight fast of at least 10 hours.
15929917|NCT03420092|Drug|Form 5 of AZD5718 tablets|The participants will be dosed with Form 5 of AZD5718 following an overnight fast of at least 10 hours.
15929918|NCT03420092|Drug|Selected form (Form 2 - 5) of AZD5718 tablets|The participant will be administered with selected form (one of Form 2-5) of AZD5718 tablets 30 minutes after start of the meal.
15929919|NCT03420079|Drug|FCN-411 Dose-escalation|"FCN-411 is a pan EGFR inhibitor, which has strong activity against wild type (WT), HER2, HER4 and EGFR sensitive mutations (including but not limited to T790M and L858R mutation).
~FCN-411 shows significant antitumor activity in a dose-dependent manner in in vivo models of lung cancer, esophageal cancer and pharyngeal squamous cell carcinoma mediated by EGFR."
15929920|NCT03420079|Drug|FCN-411 Dose-expansion|"FCN-411 is a pan EGFR inhibitor, which has strong activity against wild type (WT), HER2, HER4 and EGFR sensitive mutations (including but not limited to T790M and L858R mutation).
~FCN-411 shows significant antitumor activity in a dose-dependent manner in in vivo models of lung cancer, esophageal cancer and pharyngeal squamous cell carcinoma mediated by EGFR."
15929921|NCT03420066|Other|Retrospective data collection|Retrospective collection of data recorded as standard of care for patients that were implanted with the Nexus device as part of Compassionate Use duly authorized according to country specific regulations.
15929922|NCT03420053|Biological|PfSPZ Vaccine|Aseptic, purified, metabolically active, non-replicating, radiation-attenuated, cryopreserved Pf sporozoites.
15929923|NCT03420053|Other|Normal Saline Placebo|0.9% sodium chloride solution
15929924|NCT03420053|Biological|PfSPZ Challenge|Aseptic, purified, live, infectious, cryopreserved Pf sporozoites.
15929925|NCT03420040|Device|QS-M Needle Free Injector|The subjects were proficient in the two injection methods of injection of QS-M needle free syringe and Glargine pen injection
15929926|NCT03420040|Device|Glargine pen|The subjects were proficient in the two injection methods of injection of QS-M needle free syringe and Glargine pen injection
15929927|NCT03420027|Other|questionnaire to be filled in by investigators|A simple seven-item questionnaire will be filled in by the investigator before performing urgent tracheal intubation. This intubation, which will be performed as done in routine care, does not constitute a study specific intervention
15929928|NCT03420014|Drug|Doxorubicin|75 mg/m2 doxorubicin will be administered once every 3 weeks (Day 1 of every 21-days cycle).
15929929|NCT03420014|Combination Product|L19TNF plus doxorubicin|13 μg/kg L19TNF will be administered on day 1, 3 and 5 of every 21-days cycle in combination with 60 mg/m2 doxorubicin on day 1 of every 21-days cycle.
15929930|NCT03419988|Behavioral|Exercise Intervention|24 sessions of aerobic exercise
15929931|NCT03419975|Drug|TJO-002|Administrate the drugs for clinical trial one drop once daily at the same time (9 p.m. ± 1 hour) for a study eye
15929932|NCT03419975|Drug|Latanoprost|Administrate the drugs for clinical trial one drop once daily at the same time (9 p.m. ± 1 hour) for a study eye
15929933|NCT03419962|Drug|MaxSpiolto® Respimat® 160 Characters...|as per the approved SmPC
15929934|NCT03419949|Drug|oral lamotrigine 100 mg|Pain relief drug Lamotrigine inhibits the voltage-gated sodium and calcium channels. Inhibition of the voltage-gated sodium channel stabilizes the presynaptic neuronal membrane, thus preventing the release of excitatory neurotransmitters such as glutamate and inhibiting sustained repetitive neuronal firing
15929935|NCT03419949|Drug|oral pregabalin 150 mg|Pain relief using drug Pregabalin is a structural analogue of the inhibitory neurotransmitter gama-aminobutyric acid (GABA), with anticonvulsant, antihyperalgesic, and anxiolytic properties
15929936|NCT03419936|Diagnostic Test|Endoscopic biopsy|"Pre-operation (initial diagnosis) Assessment atrophy and metaplasia in stomach, Check Helicobacter pylori
~Post-subtotal gastrectomy (After 6 months) Assess the distribution of helicobacter pylori after subtotal gastrectomy.
~Post-subtotal gastrectomy (After 12 months) Assess the distribution of helicobacter pylori after subtotal gastrectomy.
~Post-subtotal gastrectomy (After 24 months) Assess the distribution of helicobacter pylori after subtotal gastrectomy."
15929937|NCT03419923|Drug|two stage regional citrate|4% trisodium citrate was infused at the arterial bubble trap at a rate according to the blood flow(3/4 x 1.2 x blood flow)ml/h,and at the venous bubble trap at a rate according to the blood flow(1/4 x 1.2 x blood flow)ml/h.
15929938|NCT03419923|Drug|one stage regional citrate|4% trisodium citrate was infused at the arterial bubble trap at a rate according to the blood flow( 1.2 x blood flow)ml/h.
15929939|NCT03419910|Drug|BMS-986165|Specified dose on specified days
15929940|NCT03419910|Drug|Cyclosporine|Specified dose on specified days
15929941|NCT03419897|Drug|Tislelizumab|Anti-PD-1 ANTIBODY
15929942|NCT03419871|Other|Monitoring Sleep|An accelerometer will be placed on the wrist or ankle of the child while the child sleeps in their home. Caregivers will be instructed to keep the accelerometer on their toddler's ankle to measure sleep duration, latency and sleep efficiency. Seven nights of data will be obtained because actigraphy is most reliably measured in young children over this time frame.
15929943|NCT03419871|Other|stress biomarkers|"Salivary and hair cortisol measurements were used to obtain a change in baseline from 12 to 24 months. Data on the timing of the saliva collection will be collected using a Medical Electronic Monitoring System (MEMScapTM) - a digital memory cap that records the timing and frequency of opening.
~Cortisol will be measure in the morning and bedtime samples. A small amount of hair (30mg) will be cut from the posterior vertex of the child's head. Due to the expected variability in hair length of toddlers, documentation of hair length will be completed. Each centimeter represents 1 month history of stress and ideally 3 cm of hair length will be collected to provide a three month history of stress."
15930548|NCT03415373|Device|Microneedle Adapter (Model UAR-2S)|Investigational device
15929944|NCT03419858|Behavioral|Mindfulness Meditation|A well-validated brief mindfulness-based mental training regimen [four sessions; 20 min/session] was used to teach patients to independently practice mindfulness meditation.
15929945|NCT03419858|Behavioral|Placebo Meditation|A well-validated brief meditation-based mental training regimen [four sessions; 20 min/session] was used to teach patients to independently practice closing their eyes and take a deep breath every few minutes.
15929946|NCT03419858|Behavioral|Slow-Breathing|Study volunteers practiced lowering their breathing rate, across four, 20 minute training sessions, in response to a fluctuating light with the guidance of a trained facilitator.
15929947|NCT03419858|Drug|Naloxone|A 0.15 mg/kg bolus dose of naloxone (Naloxone Hydrichloride, Amphastar Pharmaceuticals, Inc., Rancho Cucamonga, California) in 25ml normal saline was administered over 10 minutes. We also administered a supplementary IV infusion dose of 0.1mg/kg/hour naloxone immediately after bolus infusion ceased till the end of the experiment.
15929948|NCT03419858|Other|Saline|A 0.15 mg/kg bolus dose of saline in 25ml normal saline was administered over 10 minutes. We also administered a supplementary IV infusion dose of 0.1mg/kg/hour saline immediately after bolus infusion ceased till the end of the experiment.
15929949|NCT03419845|Device|Step Right Buddy|The Step Right Buddy, which is under investigation in this clinical study, is an elasticated band that attached by Velcro to the back legs of a standard walking frame. The purpose of the Step Right Buddy is to provide sensory feedback to standard walking frame users of how far to step in to the frame and to encourage them to move the frame forward.
15929950|NCT03419832|Other|NEAT Form|The NEAT form consists of a clear and concise overview document containing information satisfying all elements of consent. This is made up of IRB-approved wording from the regular consent form. More detailed information, such as specific clinic measures are provided as additional material and are discussed during the consent process after the general overview has been provided with the NEAT form.
15929951|NCT03419832|Other|Standard Form|The regular IRB approved version.
15929952|NCT03419819|Dietary Supplement|PKU Sphere|PKU Sphere is a glycomacropeptide based alternative to amino-acid based products for the dietary management of phenylketonuria.
15929953|NCT03419806|Drug|Infudopa i.v.|"Infudopa i.v. infusion will be given through an indwelling catheter placed in the arm. Infudopa i.v. will be delivered in 75% of the subject's individual pre-study dosing of Duodopa.
~From patient 6 and onwards:
~Infudopa IntraV, at 81% of the subject's individual pre-study daily Duodopa dose, will be delivered over a 16-h period and administered as a continuous fixed infusion rate preceded by a morning bolus dose. The i.v. morning bolus is 110% of the hourly continuous dose delivered at the rate of 60 ml/h (mixed volume rate Infudopa Active + Infudopa Buffer IntraV). The morning dose will not exceed 24 mL, corresponding to 240 mg levodopa. The maximum daily dose levodopa during i.v. administration is not allowed to exceed 3240mg (equal to 81% of the maximum allowed daily dosage for Duodopa that is 4000 mg)."
15929954|NCT03419806|Drug|Infudopa s.c.|"A suitable infusion needle will be placed laterally on the abdomen for the s.c. infusion of Infudopa. Infudopa s.c. will be delivered in the same dosage as the subject's individual pre-study dosing of Duodopa, as a morning rapid s.c. constant rate administration followed by continuous s.c. infusion up to 16 h.
~From patient 6 and onwards:
~Two infusion needles will be placed on the abdomen for the s.c. infusion of Infudopa SubC in 86% of the the subject's individual pre-study daily Duodopa dose. The intervention is given as a continuous fixed infusion rate for 16h preceded by a morning bolus dose. The s.c. morning bolus is 155% of the hourly continuous dose delivered at the rate of 80 ml/h (mixed volume rate Infudopa Active + Infudopa Buffer SubC). The morning dose will not exceed 30 mL. The maximum daily dose levodopa during s.c. administration is not allowed to exceed 3440mg (equal to 86% of the maximum allowed daily dosage for Duodopa that is 4000 mg)."
15929955|NCT03419806|Drug|LCIG (Duodopa)|"Duodopa will be administered directly to the proximal small intestine via a PEG-J tube connected to a portable infusion pump. Individually optimized dosing of Duodopa will be administered as a morning rapid constant rate administration followed by continuous infusion and, if needed, intermittent extra doses (subject-initiated based on symptom experience). The maximum daily dose levodopa during Duodopa administration should normally not exceed 3350 mg, and is not allowed to exceed 4000 mg.
~From patient 6 and onwards:
~The pre-study daily Duodopa dose will be delivered over a 16-h period and administered as a continuous fixed infusion rate preceded by a morning bolus dose. The morning bolus is 110% of the hourly continuous dose delivered at the rate of 40 ml/h. The morning dose will not exceed 15 mL, corresponding to 300 mg levodopa. The maximum daily dose levodopa is not allowed to exceed 4000mg."
15929956|NCT03419793|Device|segmental vibration device|segmental vibration device
15929957|NCT03419793|Other|physical therapy exercises|
15929958|NCT03419780|Biological|Blood Transfusion|Patients are randomized to receive 1 or 2 units of packed red blood cells for initial transfusion.
15929959|NCT03419767|Drug|Melatonin|Patients under carotid revascularization surgery taking 6mg/day melatonin orally from 3 days before operation to 3 days after operation.
15929960|NCT03419767|Other|blank|Patients under carotid revascularization surgery without taking melatonin
15929961|NCT03419754|Dietary Supplement|Glucose|Glucose
15929962|NCT03419754|Behavioral|Fidgetting|low intensity physical activity (fidgetting)
15929963|NCT03419741|Device|Transcranial Magnetic Stimulation Clinical Research System|Transcranial Magnetic Stimulation Clinical Research System is a US FDA approved treatment system for depression. The treatment research system includes motor threshold TMS coil, active TMS coil and sham TMS coil.
15929964|NCT03419728|Behavioral|Healthy Families, Healthy Futures|Home visiting program for pregnant and parenting teens
15929965|NCT03419715|Drug|Bimatoprost Topical Solution|One drop of bimatoprost topical solution is applied daily to the lunula region of the fingernail bed
15929966|NCT03419715|Drug|Control|One drop of saline solution is applied daily to the lunula of the fingernail bed on one hand.
15929967|NCT03419702|Dietary Supplement|Almonds|During the intervention period of 5 months, subjects will receive daily 50 gr almonds. Subjects are free to consume the almonds during the day whenever they want to, i.e. there will not be guidelines when to consume the almonds.
15929968|NCT03419689|Procedure|Tumour tissue collection|"Tumour tissue will be taken from samples already removed from surgery or biopsy or by new tumour biopsies:
~At the time of diagnosis or progression
~Any surgical procedures for management of tumour related medical conditions
~At each subsequent relapse or disease progression"
15930549|NCT03415373|Device|Hypodermic needle + syringe|Control device
15929969|NCT03419689|Procedure|Blood sample collection|"Blood samples will be taken:
~At the time of first diagnosis
~About 1 week after starting any treatment
~At each radiological response assessment
~At each subsequent relapse or disease progression"
15929970|NCT03419689|Procedure|Ascites Collection|"Ascites will be collected if paracentesis is required during any of the following time points:
~At the time of diagnosis or progression
~Any surgical procedures for management of tumour related medical conditions
~At each subsequent relapse or disease progression"
15929971|NCT03419689|Procedure|Fluid Collection|Additional fluid will be collected at any time a procedure for clinical management that involves the drainage of fluid (i.e. thoracentesis, or drainage of cystic lesion) is required.
15929972|NCT03419676|Device|Hemopatch|Collagen patch derived from bovine dermis, coated with NHS-PEG, applied covering the pancreaticojejunostomy after pancreatoduodenectomy once the anastomosis is completed.
15929973|NCT03419663|Dietary Supplement|cereal or grain consumption|intake of cereal, whole grain, refined grain, and other grain of every day
15929974|NCT03419650|Drug|ACTHar|Acthar™ 80 units twice a week for 4 weeks followed by 40 units twice a week until week 12.
15929975|NCT03419637|Other|Mobile app|The mobile app, or app, is installed on the patient's mobile device and is used to document the surgical procedure with before and after photographs, including pre- and post-surgery diagnosis. The app allows patients to view a skin history summary report and a reference on their skin ﬁndings and procedures.
15929976|NCT03419624|Drug|Dapagliflozin 10mg|Dapagliflozin 10 mg tablet once daily
15929977|NCT03419624|Drug|Exenatide 2 mg [Bydureon]|Exenatide 2 mg injection once weekly
15929978|NCT03419624|Drug|Placebo Oral Tablet|Placebo oral tablet once daily
15929979|NCT03419624|Drug|Placebo injection|Placebo injection once weekly
15929980|NCT03419624|Drug|Insulin|daily Insulin injections
15929981|NCT03419624|Drug|Metformin, if taken before|If the Patient has taken Metformin prior to enrollment, he or she will continue to take it.
15929982|NCT03419611|Behavioral|Multi-Modal|Intervention combining speech sound practice, AAC and receptive practice on a set of individually determined words. Words are selected based on phonological properties. Delivered 3 times per week.
15929983|NCT03419611|Other|Treatment as Usual|Teacher provided with word list and teacher intervening as usual.
15929984|NCT03419611|Behavioral|High Intensity Multi-Modal|Intervention combining speech sound practice, AAC and receptive practice on a set of individually determined words. Words are selected based on phonological properties. Delivered 5 times per week.
15929985|NCT03419598|Procedure|Opening wedge high tibial osteotomy|Realignment of knee by creating an opening wedge osteotomy in the upper part of the tibia. Since this is a virtual trial, the virtual patients were duplicated and enrolled into both arms
15929986|NCT03419598|Device|Personalised subject specific custom HTO plate|Subject specific custom plate for stabilizing an open wedge HTO
15929987|NCT03419598|Device|Generic HTO plate|Generic plate for stabilizing an open wedge HTO
15929988|NCT03419585|Device|Intervention systematic light exposure|30 minutes of intervention systematic light exposure daily
15929989|NCT03419585|Device|Comparison systematic light exposure|30 minutes of comparison systematic light exposure daily
15929991|NCT03419559|Biological|LN-145|adoptive cell therapy (ACT) with autologous TIL therapy
15929992|NCT03419559|Drug|Durvalumab|PD-L1 antagonist monoclonal antibody
15929993|NCT03419520|Behavioral|Nutritional counseling|Schoolchildren, parents and teachers from intervention schools, will regularly receive nutrition and healthy lifestyle guidelines performed by nutritionists. Moreover, workshops aimed to reinforce the healthy habits will also be held along the study.
15929994|NCT03419507|Device|Endotracheal tube introducer|The doctors that drawed envelop number 2 will be asked to intubate with laryngoscope by the adult size, endotracheal tube introducer with using No. 3 Macintosh blade
15929995|NCT03419507|Device|Macintosh laryngoscopy|The doctors who drawed envelope number 1 will asked to intubate with using No. 3 Macintosh blade
15929996|NCT03419494|Drug|PLD|PLD36mg/m2.d d1、d15，ivdrip，1h，VCR 1.4mg/m2.d d1，d8，d15，d22 iv，CTX 800mg/m2.d d1 ivdrip，L-asp 6000u/m2.d d19～28 ivdrip，Dex10mg.d d1～28 ivdrip
15929997|NCT03419494|Drug|DNR|DNR 45mg/m2.d d1～3，ivdrip，1h，VCR 1.4mg/m2.d d1，d8，d15，d22 iv，CTX 800mg/m2.d d1 ivdrip，L-asp 6000u/m2.d d19～28 ivdrip，Dex10mg.d d1～28 ivdrip
15929999|NCT03419468|Other|Self Geriatric Assessment Measure (SGAM)|Self Geriatric Assessment Measure
15930000|NCT03419442|Drug|Xofigo|Radium-223, 55kBq (1.49 microcurie) per kg body weight given at 4 week intervals for 6 injection
15930001|NCT03419442|Drug|Taxotere|Docetaxel injection 75mg/m2 every 3 weeks
15930002|NCT03419442|Drug|Jevtana|Cabazitaxel injection 25mg/m2 intravenously once every 3 weeks
15930003|NCT03419429|Drug|Simvastatin|Simvastatin is a drug used orally for treatment of hypercholesterolemia. It assists in bone regeneration and has anti-inflammatory effect when applied locally in intrabony defects for periodontal therapy.
15930004|NCT03419429|Other|EDTA|EDTA is a demineralizing agent used for root surface conditioning.
15930005|NCT03419429|Device|Occlusive membrane|Occlusive membrane is the traditional collagen resorbable membrane used in guided tissue regeneration.
15930006|NCT03419429|Device|Modified perforated membrane|Modified perforated membrane is the traditional collagen resorbable membrane but modified to be perforated. It is used in guided tissue regeneration
15930007|NCT03419416|Other|Kangaroo mother care (KMC)|Skin to skin contact of newborns with mothers and exclusive breast feeding
15930008|NCT03419403|Drug|Steroid eye drops|Solution, eye drop
15930009|NCT03419403|Drug|Vasoconstrictor eye drops|Solution, eye drop
15930010|NCT03419403|Other|Cold compress|Cold compress
15930011|NCT03419403|Drug|Ophthalmic steroid ointment|Ointment
15930012|NCT03419403|Drug|Depatuxizumab mafodotin|During the Chemoradiation Phase, participants were to receive depatuxizumab mafodotin at 2.0 mg/kg IV infusion over 30 - 40 minutes once every 2 weeks (Day 1 of Weeks 1, 3, and 5 of the 6-week regimen). During the Adjuvant Therapy Phase, participants were to receive depatuxizumab mafodotin at 1.25 mg/kg on Day 1 (± 2 days) and Day 15 (± 2 days) of each 28-day cycle as a 30 - 40 minute infusion for 12 cycles.
15930013|NCT03419403|Drug|Temozolomide|Temozolomide was to be administered according to the local standard of care. Duration of treatment was to be 6 - 12 cycles in the adjuvant phase and at the discretion of the investigator as supported by local standard of care.
15930014|NCT03419403|Radiation|Radiation|Radiation therapy treatment planning and administration was to be performed as per local institutional guidelines.
15930015|NCT03419390|Device|combined Coaxial Optical Coherence Tomography (OCT) System|The investigational device is an OCT scanner prototype with two different wavelengths developed based on a CE marked OCT device (Spectralis® Heidelberg) at the Berner Fachhochschule, Biel
15930016|NCT03419377|Other|Standard care and sexological counseling|6-8 sexological consultants in a period of six months
15930017|NCT03419364|Drug|nicotinamide|2.5 gm nicotinamide given orally in 3 divided doses: 1000 mg in morning and evening, 500 mg at noon/midday
15930018|NCT03419351|Diagnostic Test|Smartphone|Smartphone based measurement of refractive error and visual acuity testing using these measurements.
15930019|NCT03419351|Diagnostic Test|Autorefractor|Autorefractor based measurement of refractive error and visual acuity testing using these measurements.
15930020|NCT03419351|Diagnostic Test|Individual|Individual, human measurement of refractive error and visual acuity testing using these measurements.
15930021|NCT03419338|Procedure|Sinus lift|Using a lateral access, the Schneider membrane will be elevated using curettes allowing the insertion of graft material.
15930022|NCT03419338|Procedure|Surgical alveolus|Using a round diamond bur, a surgical alveolus will be created on an toothless ridge region.
15930023|NCT03419338|Procedure|Inorganic bovine bone + newly forming bone|Maxillary sinus lift will be done with inorganic bovine bone associated with newly forming bone. The newly forming bone will be collected from surgical alveolus previous prepared.
15930024|NCT03419338|Procedure|Inorganic bovine bone|Maxillary sinus lift will be done with inorganic bovine bone.
15930025|NCT03419338|Device|Collagen membrane|At the end of the sinus lift, a collagen membrane will be used to obliterate the graft inside the maxillary sinus.
15930026|NCT03419325|Genetic|CYP2C19 test|Patients will be categorized into 4 groups based on the results of their genetic test for CYP2C19 as well as the residual platelet reactivity test (P2RY12 assay=PRU units) and DAPT treatments options will be recommended accordingly (i.e., through a Clinical Decision Support (CDS) tool that is based on a pharmacogenetic-driven algorithm and the PRU result).
15930027|NCT03419325|Diagnostic Test|P2RY12 assay|Patients will be categorized into 4 groups based on the results of their genetic test for CYP2C19 as well as the residual platelet reactivity test (P2RY12 assay=PRU units) and DAPT treatments options will be recommended accordingly (i.e., through a Clinical Decision Support (CDS) tool that is based on a pharmacogenetic-driven algorithm and the PRU result).
15930028|NCT03419312|Device|Proclaim™ Elite 5: Burst - Washout - Sham|"All implanted hardware manufactured by S:t Jude Medical/Abbot:
~Implantable Pulse Generator (IPG): Proclaim™ Elite 5 IPG, model 3660. Electrode: Octrode percutaneous lead, 60 cm, model 3161. Anchor: Long lead anchor, model 1106."
15930029|NCT03419312|Device|Proclaim™ Elite 5: Sham - Washout - Burst|"All implanted hardware manufactured by S:t Jude Medical/Abbot:
~Implantable Pulse Generator (IPG): Proclaim™ Elite 5 IPG, model 3660. Electrode: Octrode percutaneous lead, 60 cm, model 3161. Anchor: Long lead anchor, model 1106."
15930030|NCT03419299|Other|Tube Feeding Application|A smart device application was developed and used to help residents determine the best enteral nutrition prescription for patients admitted to the ICU
15930031|NCT03419273|Procedure|bariatric surgery|We are recruiting only those going through bariatric surgery
15930032|NCT03419260|Other|Clinically indicated EEG monitoring.|Children enrolled in the study will be undergoing clinically indicated EEG monitoring. Some children will undergo clinically indicated electrographic seizure management.
15930033|NCT03419247|Procedure|Fresh tumor tissue biopsy|A type of surgical procedure that will use a thin needle to remove a sample of tumor tissue.
15930034|NCT03419247|Procedure|Blood draw|Blood will be taken by a needle from a vein.
15930035|NCT03419247|Procedure|Archival tumor tissue collection|A sample of tumor tissue that was taken by biopsy or surgery before agreeing to take part in this study will be collected.
15930036|NCT03419234|Drug|Abiraterone Acetate|Given PO
15930037|NCT03419234|Drug|Antiandrogen Therapy|Receive standard of care antiandrogen therapy with either LHRH agonist or antagonist
15930038|NCT03419234|Drug|Cabazitaxel|Given IV
15930039|NCT03419234|Other|Laboratory Biomarker Analysis|Correlative studies
15930040|NCT03419234|Procedure|Orchiectomy|Undergo standard of care surgical castration with bilateral orchiectomy
15930041|NCT03419234|Other|Pharmacological Study|Correlative studies
15930042|NCT03419234|Drug|Prednisone|Given PO
15930043|NCT03419221|Procedure|PET/CT Positron emission tomography (PET) using small radiotracers, a special camera and a computer to evaluate organ and tissue functions|"Open-label randomized controlled superiority trial in patients with SAB without infective endocarditis at the time of inclusion comparing whole-body PET/CT in arm A and routine care with performance of imaging studies according to anamnesis and clinical symptoms in arm B. To demonstrate that PET/CT is associated with a 20% higher frequency of detection of DFI during SAB, the inclusion of 145 patients in each arm is required.
~Randomization will be stratified on centre and SAB setting of acquisition (healthcare vs community)."
15930044|NCT03419221|Other|Patients' routine care with performance of explorations based on anamnesis and clinical symptoms|Patients' routine care with performance of explorations based on anamnesis and clinical symptoms
15930045|NCT03419208|Other|SPIN-HAND Program|The internet-based SPIN-HAND program consists of 4 modules (1) Thumb Flexibility and Strength (3 exercises); (2) Finger Bending (3 exercises); (3) Finger Extension (3 exercises); and (4) Wrist Flexibility and Strength (2 exercises). The program includes sections on developing a personalized program, goal-setting strategies and examples, progress tracking, sharing goals and progress with friends and family, and patient stories of experiences with hand disability and hand exercises. Instructional videos demonstrate and explain how to perform each exercise properly with pictures to illustrate common mistakes. Separate versions of each exercise are available for patients with mild/moderate and more severe hand involvement.
15930089|NCT03418870|Behavioral|Family Integrated Care|Parents of infants assigned to mFI-Care will be trained and treated as primary caregivers for their infants and participate in daily medical rounds, with mFI-Care-trained nurses serving as teachers and coaches.
15930046|NCT03419195|Other|Cardiovascular exercise training|Following the completion of baseline testing, both subject groups will undergo supervised cardiovascular exercise training 3 times per week for 3 months (plus a 3 week ramp-up). Exercise training will take place on a treadmill, stationary bicycle, elliptical, rowing machine, or combination of machines. Each session will last 1 hour, which includes a 5 minute warm-up, 50 minutes of exercise, and a 5 minute cool down.
15930047|NCT03419182|Procedure|Open Reduction internal Fixation|A surgeon uses hardware, such as plates and screws, to restore structural integrity and alignment of an acetabular fracture.
15930048|NCT03419182|Procedure|Open Reduction Internal Fixation with Total Hip Arthroscopy|A surgeon uses hardware, such as plates and screws, to restore structural integrity and alignment of an acetabular fracture, and replaces the cartilage and bone of the greater trochanter with prosthetic components.
15930049|NCT03419169|Device|Light load BFR resistance training|A novel training light load resistance training modality.
15930050|NCT03419169|Procedure|Heavy load resistance training|A common form of resistance training used for rehabilitation within the National Health Service.
15930051|NCT03419156|Other|Text Message Arm Intervention|Patients in the Text Message Arm will receive a weekly set of text messages inquiring about the patients' symptoms instead of a weekly phone call from the nurse team (standard of care). Potentially harmful symptoms identified by the automated system will generate an alert that will be sent to the medical team. The alert will be immediately sent via email to the nursing team. The nurse will be able to contact the patient to decide the best further treatment. The nurses will check patient response rates daily. If a patient does not respond to their weekly message, then the patient will be called.
15930052|NCT03419130|Radiation|Hypofractionated Radiation Therapy|Undergo hypofractionated RT
15930053|NCT03419130|Other|Laboratory Biomarker Analysis|Correlative studies
15930054|NCT03419130|Biological|Pembrolizumab|Given IV
15930055|NCT03419130|Radiation|Radiation Therapy|Undergo conventionally fractionated RT
15930056|NCT03419117|Procedure|ESP block|An ESP block will be performed prior to surgery for postoperative pain control
15930057|NCT03419117|Procedure|Placebo|A sham ESP block will be performed before surgery in the placebo group
15930058|NCT03419104|Diagnostic Test|preoperative walk test|Patients undergoing bariatric surgery who will complete a preoperative 60 meters 60 seconds walk test.
15930059|NCT03419091|Device|single-use flexible digital ureteroscope|Device being tested.
15930060|NCT03419091|Device|Reusable Ureteroscope|Comparative device.
15930061|NCT03419065|Behavioral|Relaxation Intervention|Relaxing Music combined with Progressive Muscle relaxation and guided imagery
15930062|NCT03419052|Behavioral|Speed of processing training|Speed of processing training is provided by the Internet-based BrainHQ program from Posit Science, Inc. BrainHQ contains five different speed training modules (Hawk Eye, Visual Sweeps, Fine Tuning, Eye for Detail, Sound Sweeps) which tap time-order judgment, visual discrimination, spatial-match, forward-span, instruction-following, and memory.
15930063|NCT03419052|Behavioral|MIND foods|"The MIND diet (created by the Rush Aging & Memory group) specifically emphasizes foods high in polyphenols such as berries, nuts, cocoa, black beans, olive oil, and green leafy vegetables. Participants select these foods from the digital study application and receive them through home delivery."
15930064|NCT03419052|Behavioral|Cognitive training control|Control training is provided by the Internet-based BrainHQ program from Posit Science, Inc.These are inert games such as tic-tac-toe, connect 4, battleship, etc.
15930065|NCT03419052|Behavioral|Control foods|Foods contain low polyphenols. Participants select these foods from the digital study application and receive them through home delivery.
15930066|NCT03419039|Dietary Supplement|Anthocyanins|Medox tablet containing 80 mg anthocyanins.
15930067|NCT03419039|Dietary Supplement|Placebo|Identically appearing capsules.
15930068|NCT03419013|Other|New adhesive strip|This strip is made of a newly developed adhesive
15930069|NCT03419000|Genetic|blood sample|Seven blood samples (4 ml each on 5 EDTA and 2 dry tubes) will be collected in each patient/ healthy volunteers subject to determine the expression profile of miRNAs in the plasma as well as in the exosomes
15930070|NCT03418987|Other|Medical File data analysis|Analysis of the 2D/3D spine images (performed with the sterEOS software and the MATLAB software)
15930071|NCT03418974|Drug|Pitavastatin|Capsule/Tablet, oral, follow the doctor's advice Participants will receive pitavastatin treatment for 3 or 12 weeks.
15930072|NCT03418974|Drug|Atorvastatin|Capsule/Tablet, oral, follow the doctor's advice Participants will receive atorvastatin treatment for 3 or 12 weeks.
15930073|NCT03418974|Drug|Rosuvastatin|Capsule/Tablet, oral, follow the doctor's advice Participants will receive rosuvastatin treatment for 3 or 12 weeks.
15930074|NCT03418961|Drug|Carvedilol|Given PO
15930075|NCT03418961|Other|Laboratory Biomarker Analysis|Correlative studies
15930076|NCT03418961|Other|Patient Observation|Undergo observation
15930077|NCT03418948|Device|CC followed by EC|CC = conventional colonoscopy EC = endocuff assisted colonoscopy
15930078|NCT03418948|Device|EC followed by CC|CC = conventional colonoscopy EC = endocuff assisted colonoscopy
15930079|NCT03418948|Device|2x EC|EC = endocuff assisted colonoscopy
15930080|NCT03418948|Device|2x CC|CC = conventional colonoscopy
15930081|NCT03418935|Drug|Remaxol (succinate + methionine + inosine + nicotinamide)|Solution for intravenous infusions, containing succinate, methionine, inosine, and nicotinamide in 400 ml glass bottle
15930082|NCT03418935|Drug|Ringer's Solution|Intravenous infusion, 400 or 800 ml
15930083|NCT03418922|Drug|Lenvatinib|Specified doses will be administered orally on specified days.
15930084|NCT03418922|Drug|Nivolumab|Specified doses will be administered intravenously on specified days.
15930085|NCT03418909|Procedure|Primary Trans Oral Robotic Surgery (TORS)|In the absence of severe mobidity patients with early stage disease (T1-2, N1, M0) were offered TORS, as an alternative to the standard of care (radiotherapy).
15930086|NCT03418909|Radiation|Radio(chemo)therapy|As the standard of care radiotherapy was offered to all of the patients. Patients that qualified for both TORS and radiotherapy were free to choose between the two.
15930087|NCT03418896|Drug|human chorionic gonadotropin|a single injection of a standard dose
15930088|NCT03418883|Other|Mirror therapy|
15930550|NCT03415360|Procedure|cryoablation|cryoablation of nerve responsible for phantom limb pain
15930090|NCT03418857|Drug|Yogurt smoothie with BB-12|During the one month intervention period, the participants will consume one yogurt smoothie with BB-12 daily.
15930091|NCT03418857|Drug|Yogurt smoothie|During the one month control period, the participants will consume one yogurt smoothie daily.
15930092|NCT03418844|Other|Self-questionnaires of living conditions and quality of life|Patients will complete self-questionnaires of living conditions and quality of life (MFI-20, FACT-G/FACT-O, FACT/COG-NTX, FACT-Cog, HADS, Insomnia Severity Index , International Physical Activity Questionnaire)
15930093|NCT03418844|Diagnostic Test|Cardiac, pulmonary, auditory and biological assessment|"Patients will perform :
~Cardiac assesments (ECG, Carotid and humeral Doppler ultrasound, Trans-thoracic echocardiography 2D and 3D)
~Pulmonary and auditory assesment ( Respiratory Functional Exploration, Tonal audiogram)
~Blood tests"
15930094|NCT03418831|Drug|Raloxifene Hydrochloride|60 mg per capsule (1 tablet daily) for 12 weeks
15930095|NCT03418831|Other|Placebo|1 tablet daily for 12 weeks
15930096|NCT03418818|Drug|18F-FAZA|18F-FAZA is a radiotracer used for PET imaging (in combination with MRI) to detect hypoxia in tumours. This scan will be done before and after their radiation treatment.
15930097|NCT03418805|Drug|Advil Ibuprofen table 200 mg|"Administration of the comparator drug:
~Three tablets (dosing at a 4-hour interval, q4h) of reference ibuprofen standard products, followed by 24 hours after the first dose administration."
15930098|NCT03418805|Drug|Motrin IB Ibuprofen Tablets 200 mg|"Administration of the comparator drug:
~Three tablets (dosing at a 4-hour interval, q4h) of reference ibuprofen standard products, followed by 24 hours after the first dose administration."
15930099|NCT03418805|Drug|Ibuprofen CR Tablets 600 mg|"Administration of the investigational product:
~Single oral dose of IBUCR, followed by 28 and 32 hours after the dose administration for fasted and fed studies, respectively"
15930100|NCT03418792|Other|Parotid-Sparing Head & Neck Radiation Guided by MRI Sialography|Head & neck radiation with parotid sparing. Parotid sparing will be facilitated by avoidance of salivary ductal structures and stem cells, as identified by the pre-treatment MRI sialogram, in the radiation treatment plan.
15930101|NCT03418779|Drug|The Yi-Qi-Qing-Jie herbal compound|The compounds are blends of individual herbal extracts from YQF (consisting of Astragalus membranaceus, Saposhnikovia divaricata (turcz.) Schischk, Flos lonicerae, Angelica sinensis, Dioscorea nipponica, Hedyotis diffusa Willd, rhubarb, Spatholobus suberectus, with the effect of reinforcing Qi and activating blood, clearing away heat and poison, dissolving dampness and downbearing turbid) dissolved in 150 ml boiled water and taken orally twice a day for the duration of the treatment and follow-up phases.
15930102|NCT03418779|Drug|Immunosuppressants|Immunosuppression therapy comprises oral prednisolone (0.5-0.8 mg/kg/day; exact dose decided by the investigator, maximum dose not exceeding 60 mg/day) for 8 weeks, then tapered by 5-10 mg/day every 4 weeks, with a total treatment period of 24-32 weeks. Participants with persistent proteinuria ≥ 1 g/day after 8 weeks of corticosteroid monotherapy will receive 0.8-1.0 g of intravenous cyclophosphamide (CTX) every 4 weeks, total dose of not exceeding 8 g (exact dose decided by the site investigator). If severe CTX-related adverse events occur, such as alanine transaminase (ALT) exceeding the upper limit of two times, infections requiring hospitalization, granulocytes < 3.0 × 109/L and platelets < 50.0 × 109/L, CTX will stop being administered, symptoms will be treated, and adverse events recorded. Also, the frequency of detection will be increased to once every 2 weeks and the affected participant will be withdrawn if persistent infection or myelosuppression occurs.
15930103|NCT03418779|Other|Optimized Supportive Care|"The optimized supportive care included:
~Lifestyle: low-salt, restricted protein dietary with sufficient calorie supply, smoking cessation, moderate alcohol consumption and keeping a healthy weight
~The use of renin-angiotensin system blockade: lowering blood pressure to a target below 135/85 mmHg, during which treatment was adjusted to ensure that patients were receiving the maximum labelled or tolerated dose of RAS blockade
~Patients with Diabetes Mellitus received insulin or oral hypoglycemic agents to achieve HbA1c≤ 7.0%
~Received uricosuric agents or xanthine oxidase inhibitors as necessary to achieve serum uric acid <6 mg/dL in female, <7 mg/dL in male"
15930104|NCT03418779|Other|Yi-Qi-Qing-Jie herbal compound placebo|Patients will receive Yi-Qi-Qing-Jie herbal compound placebo instead for the duration of the treatment and follow-up phases. The major component of the placebo is malt dextrin which looks, smells and tastes like YQF compound, and it comes in packaging with a similar appearance to YQF compound; it is also dissolved in 150 ml boiled water and taken orally twice a day.
15930105|NCT03418753|Diagnostic Test|EyeBOX for ICP|non-invasive ICP Score algorithm using eye-tracking data from the EyeBOX(TM) device, which tracks the movement of the pupils over time
15930106|NCT03418727|Drug|Brimonidine|Two products delivered in sequence twice daily.
15930107|NCT03418727|Drug|Brimonidine Mono Therapy|Brimonidine given twice daily along with placebo drops
15930108|NCT03418727|Drug|sodium carboxymethylcellulose|Placebo given twice daily.
15930109|NCT03418727|Drug|Corticosteroid Eye Drop|Eye drop to be administered after Briomonidine in treatment arm 1
15930110|NCT03418714|Drug|Salvinorin A|Salvinorin A, blinded doses
15930111|NCT03418701|Behavioral|Health Smart for Weight Loss|We will test the effectiveness of a culturally sensitive, evidence-based, multi-component, behavioral program for treating obesity called Health-Smart. This program will be implemented for 6 months in 20 UF Health Jacksonville primary care clinics by Community Health Workers (CHWs) with Black women patients who have obesity, and followed by either of two physician-implemented behavioral counseling weight loss maintenance programs that are applied quarterly over 12 months to prevent weight gain. Specifically, we will compare the effects on weight-loss and weight-loss maintenance of (1) Health-Smart plus the Patient-Centered, Culturally Sensitive Weight Loss Maintenance Program (PCS-WLM), and (2) Health-Smart plus the Standard Behavioral Weight Loss Maintenance Program (SB-WLM).
15930112|NCT03418688|Drug|COR388|COR388 administered for 10 or 28 days.
15930113|NCT03418688|Drug|Placebo|Placebo administered for 10 or 28 days.
15930114|NCT03418675|Drug|Rexulti|Atypical antipsychotic
15930115|NCT03418675|Drug|Placebo|Pill that contains no medicine
15930116|NCT03418662|Device|EndoRings device|Subjects randomized to undergo a colonoscopy procedure with the EndoRings device will have the device placed on the colonoscope that will be used during their procedure.
15930117|NCT03418649|Drug|Eplerenone 50 Mg Tab|50 mg PO per day for 10 days
15930118|NCT03418649|Drug|Placebo Oral Tablet|PO once daily for 10 days
15930551|NCT03415347|Procedure|Abscess de-roofing and curettage|Abscess de-roofing and curettage
15930119|NCT03418636|Behavioral|Staying Safe (Ssafe)|Staying Safe motivates and teaches young people who inject drugs (PWID) planning skills and drug use management strategies to enable long-term risk avoidance and the implementation of healthy protective behaviors. Content is presented through guided discussions and role playing exercises, and relies heavily on interactive participation by group members to foster peer-based learning and social reinforcement processes.
15930120|NCT03418636|Behavioral|Healthy Living|The content of the Healthy Living intervention is based on the DHHS' Eat Healthy, Be Active Community Workshop curriculum, supplemented with basic sleep hygiene education. Science-based dietary and light physical activity guidelines are demonstrated and promoted to help participants develop and maintain a healthy lifestyle.
15930121|NCT03418623|Drug|GET73|GET73 300 mg oral capsules, administered three times a day on Visit 2 and 4, and twice a day on Visit 3 and 5.
15930122|NCT03418623|Other|Placebo|Placebo oral capsules, administered three times a day on Visit 2 and 4, and twice a day on Visit 3 and 5.
15930123|NCT03418610|Drug|Azelaic Acid foam 15%|mild to moderate rosacea
15930124|NCT03418597|Procedure|Deep local anesthesia + Virtual reality|Biopsy performed according to current practice (deep local anesthesia with premedication and lidocaïne). Patient will have a 3-D immersive experience, created using a visual and audio headset and a software labelled as medical device.
15930125|NCT03418597|Procedure|Deep local anesthesia alone|Biopsy performed according to current practice (deep local anesthesia with premedication and lidocaïne).
15930126|NCT03418584|Device|HybridAPC|HybridAPC is a device which combines submucosal fluid injection with APC
15930127|NCT03418571|Biological|ALX-0171 1.5 mg/kg|ALX-0171 1.5 mg/kg was administered via a single inhalation once daily for 3 consecutive days.
15930128|NCT03418571|Other|Placebo|Placebo was administered via a single inhalation once daily for 3 consecutive days.
15930129|NCT03418558|Drug|Trastuzumab emtansine|
15930130|NCT03418532|Combination Product|MP0250 DARPin® drug candidate, Osimertinib|Number of Cycles: until progression, unacceptable toxicity or other reasons for withdrawal
15930131|NCT03418519|Other|Constraint Induced Movement Therapy|Constraint-induced movement therapy (CIMT) is a high-dosage, efficacious, rehabilitation approach used for children with hemiplegic cerebral palsy
15930132|NCT03418506|Behavioral|SMOKELESS TOBACCO AWARENESS PROGRAM|A SMOKELESS TOBACCO AWARENESS PROGRAM was conducted for 2 consecutive weeks in all the selected schools. The intervention programme comprised of health education sessions that emphasized on the hazard of betel quid, areca-nut and smokeless tobacco. The sessions included 30 minutes power point presentation, posters, one pictorial booklets on the hazards of use of various tobacco products. Moreover we played a 30 minutes game show at follow-up visit. After completion of 2 weeks intervention programme, the same group of students completed the post-test questionnaire. Educational materials about hazards of betel quid, areca-nut and smokeless tobacco were distributed to both intervention and control groups.
15930133|NCT03418493|Drug|LY3316531 - IV|Administered IV.
15930134|NCT03418493|Drug|LY3316531 - SC|Administered SC.
15930135|NCT03418493|Drug|Placebo - IV|Administered IV.
15930136|NCT03418493|Drug|Placebo - SC|Placebo - SC.
15930137|NCT03418480|Drug|HPV vaccine|Intradermal vaccine
15930138|NCT03418454|Diagnostic Test|Buccal mucosa samples for Extraction of BACTERIAL DNA|"Sampling of the buccal mucosa after informed consent and prior to routine treatment. Similar sampling on follow up after 3,6,9,12 months.
~Extracted BACTERIAL DNA (and not human DNA) from clinical samples will be sequenced and analyzed for the 16s rRNA (BACTERIAL ribosome)."
15930139|NCT03418441|Other|Community-acquired CNS infections|Prospective observational registration of clinical characteristics and outcome
15930140|NCT03418415|Device|Renal denervation|multi-electrode catheter-based renal denervation
15930141|NCT03418402|Device|Airseal®|Total laparoscopic hysterectomy: Approach according to the Open-Laparoscopy technique and use of the insufflation system.
15930142|NCT03418402|Device|Standard insufflator|Standard insufflator
15930143|NCT03418376|Dietary Supplement|Beta-alanine supplementation|The supplementation protocol of β-alanine (Etixx® Omega Pharma Belgium NV) involves oral intake of 4 x 800mg (3.2g/day29, 43) daily with at least 2h apart of slow-release β-alanine during the first 12 weeks. After this loading period, subjects will receive a maintenance dose of 2 x 800mg (1.6g/day) β-alanine for the remaining study duration.
15930144|NCT03418376|Other|Exercise intervention|The exercise training program (6 months) involves 3 week cycles (week I-III). During week I, subjects will perform high volume moderate intensity cardiovascular cycle training (3x/week). Twice a week, subjects perform 3h training sessions (70-80% HRmax*) and once a week a 1.5h session will be executed (80-90% HRmax). During week II, subjects will perform low volume maximum intensity interval cycle training (3/w). High intensity interval cycle training (HIIT) will consist of 3x maximal sprints (90-100% HRmax) of 1.5min, interspersed with 3min rest intervals. A 5min standardized warming up and 5min cooling down will be performed. Week III involves a recovery week where subjects will perform one training session of 1.5h at an exercise intensity of 70-80% HRmax and one session of HIIT.
15930145|NCT03418363|Dietary Supplement|DHEA Oral Capsule|Daily 100mg DHEA supplement
15930146|NCT03418363|Other|Placebo Oral Capsule|Daily oral capsule
15930147|NCT03418337|Drug|dexilansoprazole (Dexilant 60 mg)|evaluate the response rate (symptom free) during the 8-week PPI therapy for atypical GERD between dexlansoprazole group and lansoprazole group
15930148|NCT03418337|Drug|lansoprazole (Takepron OD 30 mg)|lansoprazole group
15930149|NCT03418324|Drug|TRC105|Patients will receive TRC105 10mg weekly x 4, and then 15 mg/kg every 2 weeks
15930150|NCT03418324|Drug|Abiraterone|Patients who are progressing on Abiraterone will undergo a washout period and then continue treatment with standard dosing of Abiraterone plus TRC105.
15930151|NCT03418324|Drug|Enzalutamide|Patients who are progressing on Enzalutamide will undergo a washout period and then continue standard treatment with Enzalutamide plus TRC105.
15930152|NCT03418311|Device|Cervical Pessary-Group|Placement of the cervical pessary (non-invasive) at enrolment including a transvaginal ultrasound to verify its correct fit. Removal of the cervical pessary (non-invasive) in a regular preventive examination at week of gestation 37+0. Except for placement/removal of cervical pessary the pregnant women will receive the usual care.
15930153|NCT03418298|Behavioral|Prehabilitation group|Subjects will performed an internet-based exercise program before surgery
15964155|NCT03157557|Behavioral|Lifestyle treatment|Lifestyle treatment
15930154|NCT03418272|Diagnostic Test|Culture/PCR Analysis|"Microbes to be selectively cultured and PCR analysis to be conducted. Bacteria obtained in samples will be dispersed in non-selective Mueller Hinton Broth (Sigma-Aldrich), divided into two separate cultures and grown overnight at 37°C in aerobic condition and in 5% CO2 to assure survival of both aerobic and facultative anaerobic species.
~Staphylococcus aureus (MSSA, MRSA)
~Pseudomonas aeruginosa
~Haemophilus influenza
~Streptococcus pneumonia
~Streptococcus Pyogenes Group B streptococci,
~Klebsiella pneumonia
~Moraxella catarrhalis"
15930155|NCT03418259|Device|KCS Medical Device|Patient treated 6 times with the Active KCS Medical Device during 2 weeks.
15930156|NCT03418259|Device|KCS Medical Device|Patient treated 6 times with the Inactive KCS Medical Device during 2 weeks.
15930157|NCT03418246|Device|GIC|tooth colored filling
15930158|NCT03418246|Device|Biodentine|White filling -Biodentine
15930159|NCT03418233|Drug|CardioCell|"Patients randomized to the active treatment group will receive transcoronary or trans-bypass graft administration of 30 000 000 cells (suspended in 20 ml of 0.9% NaCl and 5% albumin).
~Injection will be performed using a dedicated cell delivery catheter. The cell delivery catheter is a typical coronary balloon catheter that is CE marked (1.2x10 mm balloon, RX system) modified to include cell delivery perforations in the balloon section of the catheter. The cell delivery catheter has been demonstrated not to affect cell viability or other cell properties."
15930160|NCT03418233|Drug|Placebos|Patients randomized to the placebo group will receive Placebos consist 0.9% NaCl and 5% albumin injections (in the same volumes as CardioCell) via the coronary arter(ies)/bypass grafts. The CardioCell and placebo are distributed encoded, in an indistinguishable form.
15930161|NCT03418220|Other|blood and aqueous humor sampling|The blood sample will be centrifuged. The plasma will be recovered. Plasma and aqueous humor will be frozen and stored at -80° Celsius. The search of 27 markers of inflammation will be performed by the kit LUMINEX Bio-rad (Bio-Rad, M500KCAF0Y).
15930162|NCT03418207|Procedure|trans-perineal template-guided mapping biopsy|new super saturation of prostate biopsy technique
15930163|NCT03418194|Procedure|transcutaneous acupoint electrical stimulation|Transcutaneous acupoint electrical stimulation(TAES) is a kind of noninvasive therapy similar to acupuncture and moxibustion. Its physiological effect is similar to that of electroacupuncture and hand acupuncture which is a Chinese traditonal therapy using acupuncture.
15930164|NCT03418194|Procedure|sham transcutaneous acupoint electrical stimulation|Sham transcutaneous acupoint electrical stimulation is the same procedure as transcutaneous acupoint electrical stimulation at points without electronic stimulation.
15930165|NCT03418181|Procedure|Standard Haemodialysis|Thrice weekly dialysis.
15930166|NCT03418181|Procedure|Incremental dialysis|Individualised dialysis dose according to native kidney function.
15930167|NCT03418168|Drug|Molidustat (BAY85-3934)|Starting dose of molidustat once daily (OD) will be titrated based on the subject's Hb (Hemoglobin) response
15930168|NCT03418155|Drug|Treatment of TongBi Capsule|TongBi Capsule:0.31g,3times a day, oral, for 4 weeks.
15930169|NCT03418155|Drug|Treatment of TongBi placebo|TongBi placebo:0.31g,3times a day, oral, for 4 weeks.
15930170|NCT03418142|Behavioral|Priovi|Priovi is an Internet intervention for people with BPD. Content is continuously adapted to patients' concerns and needs. Priovi is a comprehensive program, which is conceptually and substantially based on the schema therapeutic approach used in BPD patients. It contains interactive dialogues that can be accessed via computer or smartphone, illustrations, audios and motivating text messages. Techniques to cope with borderline symptoms (e.g., psychoeducation about modes, schemas and basic emotional needs in addition to relevant strategies to weaken, reduce and/or heal maladaptive schemas and modes) are conveyed in interactive sequences that are accompanied by audio recordings, illustrations, and worksheets. Patients are also prompted to regularly complete brief symptom severity self-monitoring questionnaires. Optional daily text messages with motivational content accompany the program. The program can be accessed for 365 days after registration.
15930171|NCT03418142|Other|CAU|Care as Usual: In the CAU/wait list control group, participants are free to continue to engage with any treatment they require (i.e., CAU). However, they will receive access to Priovi after 12 months post-baseline (i.e., wait list with respect to Priovi access).
15930172|NCT03418129|Device|Mindfulness|Neromodulatory intervention for pain management
15930173|NCT03418129|Device|Neurofeedback|Neuromodulatory intervention for pain management
15930174|NCT03418129|Device|Relaxation|Neuromodulatory intervention for pain management
15930175|NCT03418116|Device|Argus II Retinal Prosthesis|The Argus II System is designed to provide visual function to individuals with severe to profound vision loss due to outer retinal degeneration. It consists of implanted and external components. The implant is an epiretinal prosthesis that is surgically implanted in and around the eye. The external equipment includes glasses and a video processing unit (VPU). The glasses include a miniature video camera, which captures video images, and a coil that sends data and stimulation commands to the implant. The VPU converts the video images into stimulation commands and is body-worn. The Argus II System operates by converting video images into electrical energy that activates retinal cells, delivering the signal through the optic nerve to the brain where it is perceived as light.
15930176|NCT03418103|Device|Thermal imaging analysis of participant position in a hospital bed|The SAFE sensor system will use thermal imaging to detect and identify a participant's position relative to the edges of the hospital bed. If a dangerous position is identified, an alarm notification will be sent to the ward staff to allow them to take pre-emptive action to prevent the participant's situation from evolving into a fall event.
15930177|NCT03418090|Drug|129Xe MRI|Evaluation of pulmonary function
15930178|NCT03418090|Drug|133XE scintigraphy|Evaluation of pulmonary function
15930212|NCT03417908|Procedure|PNF|The contract-relax method of proprioceptive neuromuscular facilitation (PNF) technique will be used for stretching of ESC, ECM and external intercostals muscles. The contraction of agonist muscles against the resistance imposed by the physiotherapist (isometric contraction) will be maintained for 6 seconds. After that, the patient is oriented to relax the muscles for 6 seconds without losing range of motion, and then the muscle will be lengthened. This procedure is repeated until the maximum amplitude of motion of the neck and upper limb is reached. The stretching will be performed on the right and left sides of the body.
15930213|NCT03417908|Procedure|Sham|Isotonic concentric contraction of the biceps (two sets of five push-ups elbow in both arms) with the individual sitting in a chair with back support.
15930179|NCT03418077|Dietary Supplement|Energy Drink|Participants will consume a randomly assigned single 24 oz can of an original flavor energy drink within a 30-minute period. Baseline ECG, HR, BP, blood sample and body weight will be obtained. Then perform a continuous, progressive treadmill or bicycle ergometry test until volitional exhaustion. ECG will be monitored continuously during exercise, rating of perceived exertion (RPE) will be recorded every minute of each workload increase. After completion of exercise, subject will remain standing on treadmill (or seated on ergometer) for 10 minutes while ECG, BP, HR and blood samples are obtained. Subsequent ECG measures will be obtained at 1,4,7 and 10 minutes. After 10 minutes, the subjects will be free to sit, stand or move quietly in the lab. During the 2-hour post exercise monitoring period, subject's ECG, HR, BP will be recorded at 30-minute intervals. Blood samples will be collected immediate upon cessation of exercise, at 1 and 2 hours post exercise
15930180|NCT03418077|Dietary Supplement|Placebo-control|Participants will consume a randomly assigned single 24 oz can of control drink within a 30-minute period. Baseline ECG, HR, BP, blood sample and body weight will be obtained. Then perform a continuous, progressive treadmill or bicycle ergometry test until volitional exhaustion. ECG will be monitored continuously during exercise, rating of perceived exertion (RPE) will be recorded every minute of each workload increase. After completion of exercise, subject will remain standing on treadmill (or seated on ergometer) for 10 minutes while ECG, BP, HR and blood samples are obtained. Subsequent ECG measures will be obtained at 1,4,7 and 10 minutes. After 10 minutes, the subjects will be free to sit, stand or move quietly in the lab. During the 2-hour post exercise monitoring period, subject's ECG, HR, BP will be recorded at 30-minute intervals. Blood samples will be collected immediate upon cessation of exercise, at 1 and 2 hours post exercise
15930181|NCT03418064|Device|Fanfilcon A toric lens|Contact lens
15930182|NCT03418064|Device|Lotrafilcon B toric lens|Contact lens
15930183|NCT03418051|Other|Joint Mobilization|Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of Grade II anterior to posterior ankle joint mobilizations with 1-minute between sets. Mobilizations will be large-amplitude, 1-s rhythmic oscillations from the mid- to end range of arthrokinematic motion.
15930184|NCT03418051|Other|Massage|Participants will receive 6, 5-minute treatment sessions over 2-weeks. Each session will consist of 2, 2-minute bouts of plantar massage with 1-minute between sets. The massage will be a combination of petrissage and effleurage to the entire plantar surface.
15930185|NCT03418038|Dietary Supplement|Ascorbic Acid|Given IV
15930186|NCT03418038|Drug|Carboplatin|Given IV or PO
15930187|NCT03418038|Drug|Cisplatin|Given IV or PO
15930188|NCT03418038|Drug|Cytarabine|Given IV or PO
15930189|NCT03418038|Drug|Dexamethasone|Given IV or PO
15930190|NCT03418038|Drug|Etoposide|Given IV or PO
15930191|NCT03418038|Drug|Gemcitabine Hydrochloride|Given IV or PO
15930192|NCT03418038|Drug|Ifosfamide|Given IV or PO
15930193|NCT03418038|Other|Laboratory Biomarker Analysis|Correlative studies
15930194|NCT03418038|Drug|Oxaliplatin|Given IV or PO
15930195|NCT03418038|Other|Placebo Administration|Given normal saline IV
15930196|NCT03418038|Other|Questionnaire Administration|Ancillary studies
15930197|NCT03418038|Biological|Rituximab|Given IV
15930198|NCT03418025|Behavioral|Exercise Intervention|Undergo Exercise Together intervention
15930199|NCT03418025|Other|Questionnaire Administration|Ancillary studies
15930200|NCT03418025|Other|Survey Administration|Ancillary studies
15930201|NCT03418012|Device|cervical pessary|Intervention: Device: Cervical pessary: After Having excluded a vaginal infection insertion of the cervical pessary (silicone ring) directly after enrollment. After insertion verification of correct fit of the cervical pessary by transvaginal ultrasound. Removal of the pessary at 37+0 weeks of gestation, or before if any unexpected event occurs. Except for the insertion of the pessary the obstetrical management during the remainder of the pregnancy will be usual management.
15930202|NCT03418012|Other|Control-Group|Intervention: Other: expectant management: expectant management is usual care; interventions only in terms of a tertiary prevention of PTB according to guidelines for premature rupture of membranes, premature labour or other pregnancy complications
15930203|NCT03417999|Drug|Dexmedetomidine|Dose-escalation of atomized intranasal dexmedetomidine
15930204|NCT03417986|Drug|TEP|"For safety reasons the clinical trial will first enroll 14 subjects (7 patients and 7 healthy volunteers) for Group 1a receiving 26 mg TEP daily for 4 days with subsequent safety evaluation, based on adverse events and the safety parameters discussed in the protocol. A second set of patients (Group 1b), which will receive a higher dosage of 52 mg per day for 4 days will be enrolled optionally after recommendation to continue and subsequently treatment Group 2 with a treatment paradigm of 26 mg TEP daily for 54 days will start.
~Subjects eligible for participation are subjects with newly diagnosed (within last 12 month) early-to-mild dementia due to AD and healthy volunteers who fulfill all inclusion criteria and have none of the exclusion criteria present at screening."
15930205|NCT03417973|Device|dorsal root ganglion neuromodulation|stimulation for neuromodulation of the dorsal root ganglion
15930206|NCT03417960|Device|iTBS|The investigators will treat post-partum depressed subjects with accelerated intermittent theta burst stimulation. iTBS will be delivered via a MagVenture MagPro100 and Cool-B65 coil. The investigators will use a standard resting motor threshold (rMT) determination to determine the TMS dose. Treatment will be delivered at 120% of the motor threshold. The accelerated paradigm will consist of 6 such sessions separated by 30 minutes. Treatments will be delivered at the 10-20 EEG coordinate for F3 (approximating the left DLPFC), and will be found using the Beam-F3 method.
15930207|NCT03417947|Dietary Supplement|Vitamin D bolus|One single oral liquid vitamin D3 supplement of 300 000 IU
15930208|NCT03417947|Dietary Supplement|Placebo|Placebo identical in taste and appearance to the vitamin D bolus
15930209|NCT03417934|Procedure|Hip Arthroscopy Procedure|The purpose of this pilot study is to evaluate the effects of hip distraction without a perineal post on the lower extremity during hip arthroscopic procedures by peri-operative monitoring of various prognostic markers for venous, nerve and tissue injury.
15930210|NCT03417921|Drug|ABTL0812|ABTL0812 in combination with gemcitabine and nab-paclitaxel
15930211|NCT03417921|Drug|Gemcitabine and nab-paclitaxel|Gemcitabine and nab-paclitaxel as standard pattern
15930214|NCT03417895|Drug|SHR-1210|A humanized anti-PD-1 monoclonal antibody
15930215|NCT03417895|Drug|Apatinib|A tyrosine kinase inhibitor selectively targeting VEGFR-2
15930216|NCT03417882|Biological|GRN-1201 + Pembrolizumab|GRN-1201 will be administered in combination with Pembrolizumab
15930217|NCT03417869|Device|QuickVue Influenza A+B|Rapid diagnostic test with IVD, QuickVue Influenza A+B
15930218|NCT03417843|Device|EUSRA RF electrode|"At the tip of the needle there is a probe that releases the peripheral energy in a continuous and continuous manner. The method is a long 50W power release for 10 seconds or 40W until white bubbles appear in a sonographic image.
~Materials that come into contact with the body: electrode and grounding surfaces"
15930219|NCT03417830|Drug|GSK2315698 (CPHPC)|GSK2315698 will be administered as 20 milligrams per hour (20 mg/hour) IV infusion (in the vein) for up to 72 hours followed by 60 milligrams (mg) three times daily as SC injection for 8 days. Dose level and frequency will be adjusted according to renal function.
15930220|NCT03417830|Drug|GSK2398852 (unlabeled anti-SAP mAb)|Subjects will be administered up to 490 mg of GSK2398852, IV. Dose level will be adjusted based on emerging imaging data.
15930221|NCT03417830|Drug|89Zr-GSK2398852 (89Zr-labeled anti-SAP mAb)|89Zr-GSK2398852 will be available as solution containing 10 mg 89Zr-GSK2398852 for Infusion. Subjects will be administered 37 (Megabecquerel) MBq radioactive dose of 89Zr-GSK2398852 by the IV route at each dosing session.
15930222|NCT03417817|Device|Bravo|wireless pH monitoring over 96 hours
15930223|NCT03417791|Other|no intervention|no intervention
15930224|NCT03417778|Drug|Filgotinib|100 mg tablet administered orally
15930225|NCT03417765|Drug|FE 203799|GLP-2 analogue, once weekly, subcutaneous administration
15930226|NCT03417752|Other|Exposure to firearm safety PSA|Exposed to firearm safety PSA
15930227|NCT03417752|Other|Exposure to health promotion PSA|Exposed to general health promotion PSA
15930228|NCT03417739|Drug|BVD-523|In the laboratory BVD-523 works against proteins called ERK to decrease tumor growth
15930229|NCT03417713|Device|Fluoroscopic imaging with the OEC Elite Device|Vascular, gastrointestinal (GI), urology or pain management procedures for which use of the OEC Elite system in the vascular configuration would be prescribed.
15930230|NCT03417700|Dietary Supplement|NW training|NW training
15930231|NCT03417700|Dietary Supplement|Placebo|training with placebo
15930232|NCT03417700|Dietary Supplement|HICT|Training and vitamin D
15930233|NCT03417687|Drug|129Xe MRI|Evaluation of pulmonary function
15930234|NCT03417687|Drug|133 Xe scintigraphy|Evaluation of pulmonary function
15930235|NCT03417674|Combination Product|Lifestyle intervention|Meal replacement by formula diet, exercise stimulation, and telemedicine coaching.
15930236|NCT03417661|Drug|HEXI-PREP By Clinell Wipes|Sterile single sachet wipe containing 3ml solution.
15930237|NCT03417661|Drug|Chloraprep|Sterile applicator containing 3ml solution.
15930238|NCT03417661|Drug|Placebos|Sterile saline (0.9% w/v) wipe, containing 3ml of solution.
15930239|NCT03417648|Other|Plant-based diet|Weekly instructions will be given to the participants in the intervention group about following vegan diet.
15930240|NCT03417648|Other|Supplement|unrestricted diet with clinically insignificant amount of omega- 3 oils and vitamin E
15930241|NCT03417635|Behavioral|Guided focused attention|Participants will meet for 20 minute group sessions with 6-10 participants in each group. There will be three meetings a week for a four week period. The focused attention practice itself will last for 20 minutes with instructions being given during the 20 minute period. All sessions will occur in the retirement home in a community room to ensure the sessions are easily accessible to the participants.
15930242|NCT03417635|Behavioral|Acoustic music|Participants will meet for 20 minute group sessions with 6-10 participants in each group. There will be three meetings a week for a four week period. The acoustic music track itself will last for 20 minutes with instructions being given during the 20 minute period. All sessions will occur in the retirement home in a community room to ensure the sessions are easily accessible to the participants.
15930243|NCT03417622|Procedure|Bracketing|At the beginning of therapy, ultrasonographic examination is used to measure the tumor in three dimensions and bracket the tumor using 4-6 metal clips which will serve as markers for the initial tumor extent in case of tumor shrinkage in response to systemic treatment.
15930244|NCT03417622|Drug|Neoadjuvant therapy|All patients will receive primary systemic therapy according to the current institutional guidelines. Drugs include cytotoxic chemotherapy, hormonal therapy and/or anti-HER2/neu therapy as indicated.
15930245|NCT03417622|Procedure|Post-treatment volume margin resection|The lumpectomy resection margin is planned according to the identifiable tumor at operation. The initial extent of the tumor at diagnosis is not taken in account. If there is complete clinical response to systemic therapy (i.e. no identifiable tumor), the center of the bracketed tissue is biopsied.
15930246|NCT03417622|Procedure|Pre-treatment volume margin resection|The lumpectomy includes the whole bracketed tissue to take in account the initial tumor extent before systemic therapy.
15930247|NCT03417609|Device|Tongue strength measurement|The Iowa Oral Performance Instrument is a validated device for assessing the strength of the tongue. This involves placing the tip of a tube in the mouth and asking the patient to exert pressure on it.
15930248|NCT03417609|Procedure|Blood sampling|Blood sampling
15930249|NCT03417609|Diagnostic Test|Mini Mental State Examination (MMSE)|Also called Folstein test, it is an assessment of the patient cognitive and memory functions. It detects cognitive disorders or dementia. The MMSE is quickly realizable and explores several cognitive functions through 30 questions divided into 7 items.
15930250|NCT03417609|Diagnostic Test|Minimal nutritional assessment (MNA-SF)|The minimal nutritional assessment - short form is a simple, non - invasive and validated scale for the detection of malnutrition in the elderly patient.
15930251|NCT03417609|Diagnostic Test|Dual-energy x-ray absorptiometry (DEXA)|Dual-energy x-ray absorptiometry (DEXA) is the imaging technique recommended for the diagnosis of sarcopenia.
15930252|NCT03417609|Device|Dynamometer (Hand grip )|By placing a dynamometer in the patient's hand and asking him to apply maximum pressure to it, the muscular strength of the extremities of the limbs is estimated.
15930253|NCT03417609|Diagnostic Test|Walking speed|Walking speed evaluates the muscular performance. The seated patient must get up and walk a distance of 6 meters as quickly as possible without the help of a third party.
15930254|NCT03417596|Other|Control|Routine treatment
15930255|NCT03417596|Behavioral|Vestibular Rehabilitation|Exercise and rehabilitation programme was individualized
15930256|NCT03417583|Other|Protocol Intervention Group|For neuropsychiatric symptoms identified by the clinician, the treatment protocol, based on clinical standard of care, will be implemented. This protocol includes directions for multidisciplinary treatment of 7 neuropsychiatric symptoms: depression, apathy, anxiety, agitation/irritability, obsessive compulsive behaviors, delusions/hallucinations, and sleep dysfunction. These treatment recommendations differ according to symptom but include provision of additional information to patients and caregivers, psychotherapy/counseling, and pharmacotherapeutic treatment options including recommended agents and follow-up schedule.
15930257|NCT03417570|Procedure|Esophagogastroduodenoscopy with high definition-white light end endoscopy (HD-WLE) and narrow band imaging (NBI)|-The second endoscopist will be blinded to the results of the initial exam.
15930258|NCT03417570|Device|Olympus Disposable Distal Attachment Cap|-The second endoscopist will be blinded to the results of the initial exam.
15930259|NCT03417557|Device|Comfilcon A lens (test)|contact lens
15930260|NCT03417557|Device|Omafilcon B lens (control)|contact lens
15930261|NCT03417544|Drug|ATEZOLIZUMAB|(IV) every 3 weeks
15930262|NCT03417544|Drug|PERTUZUMAB|Loading dose, followed every 3 weeks thereafter by a predetermined dose in the protocol via IV
15930263|NCT03417544|Drug|TRASTUZUMAB|Predetermined dose per protocol via IV, weekly for 24 weeks and after every 3 weeks
15930264|NCT03417531|Dietary Supplement|Protein Supplement|Predosed protein powder; can be added to various dishes and drinks
15930265|NCT03417531|Dietary Supplement|Protein-free Supplement|Predosed protein-free powder; can be added to various dishes and drinks
15930266|NCT03417531|Procedure|Active Exercise|Program includes five strength exercises that can be easily performed at home
15930267|NCT03417531|Procedure|Control Exercise|Program includes five flexibility exercises that can be easily performed at home
15930268|NCT03417518|Drug|Desflurane Inhalant Product|General anesthesia will be induced with sufentanyl (0.2µg/kg) and thiopental (5mg/kg) and maintained by desflurane
15930269|NCT03417518|Drug|Propofol|General anesthesia will be induced with propofol (2mg/kg) and sufentanyl (0.2µg/kg) and maintained by propofol in a target-controlled infusion mode
15930270|NCT03417505|Device|Scleral lenses treated with Tangible Hydra-PEG|Scleral lenses treated with Tangible Hydra-PEG, a hydrophilic, PEG-based contact lens coating designed to improve lens wettability, deposit resistance, and tear film breakup time.
15930271|NCT03417505|Device|Untreated scleral lenses|Scleral lenses without the Tangible Hydra-PEG treatment will serve as a control.
15930272|NCT03417492|Drug|Sildenafil Citrate|Three 20 mg capsules for the single dose studies. For the 5-week treatment phase, subjects will be assigned to a titration of doses for the 5 week duration of the study. Subjects will be instructed to take 20mg twice per day for 3 days, then 40mg twice per day for 3 days, and then 80mg twice per day for 4 weeks.
15930273|NCT03417479|Other|Gabapentin|
15930274|NCT03417466|Device|Enlite 1 connected to iPro2 recorder|Use Enlite Sensor over 144 hours (6 days) when inserted in the abdomen and used with the iPro2 in subjects age 14 - 75 years.
15930275|NCT03417453|Device|Eye Drop Dispenser TYPE Opticare|"Subject will apply normal saline eye drops to them-self with various eye drop dispensers.
~Assessment of ease of use will be conducted by questioners."
15930276|NCT03417453|Device|Eye Drop Dispenser Autodrop|Eye Drop Dispenser Autodrop
15930277|NCT03417440|Other|Physical Activity (PA) Tracker App|This PA tracker app auto-monitors PA and provides a text-based summary of goal progress, thereby targeting self-regulation and outcome expectation.
15930278|NCT03417440|Other|On Your Feet|On Your Feet is a specialty app feature designed to be paired with a PA tracker app and reduce sedentary activity-a health risk factor largely independent of insufficient PA. This feature utilizes self-regulatory and behavior change techniques including goal-setting, progress feedback, and prompting. Accumulated sedentary activity time is displayed alongside self-selected goals; reminders to stand are sent at a user-specified frequency; and general tips and previously compiled, older adult-identified strategies to reduce sedentary activity are texted. Additionally, messages about the benefits of reducing sedentary activity and overcoming barriers are sent.
15930279|NCT03417440|Other|Coach Me|Coach Me is a specialty app feature designed to be paired with a PA tracker app and includes daily messages that assist older adults in discovering practical ways to integrate PA into their daily routines and overcoming PA barriers. Blending PA with productive activity facilitates PA engagement in older adults. In Coach Me, suggestions on how to intensify daily activities are tailored based on user selections from an activity inventory. This app feature helps older adults become more active in a minimally intrusive way, while allowing for engagement in productive and meaningful activities. Coach Me asks users to select obstacles to PA encountered in the previous week. Based on those selections, the app sends strategies on how to overcome those barriers, thereby targeting self-efficacy.
15930280|NCT03417440|Other|Proof Positive|"Proof Positive is a specialty app feature designed to be paired with a PA tracker app and capitalizes on the beneficial effects that exposure to positive aging messages and stereotypes has on health and PA. When activated, users (a) receive texts describing how old age does not equate to physical inability, (b) obtain information about the benefits of growing older, and (c) are presented with a weekly positive aging stereotype task modeled after a computerized series. This last function exposes users to blocks of positive priming words. Primers are quickly flashed to allow perception without awareness while users focus on a simple icon that represents PA. Icons are intended to provide an additional PA cue, maintain user interest, and increase the external validity."
15930281|NCT03417427|Drug|Decitabine and Ara-C|Decitabine in combination with high-dose of Ara-C is used to improve the effect of consolidation chemotherapy. It is expected to make minimal residual disease (MRD) become negative in more patients with intermediate-risk AML.
15930282|NCT03417427|Drug|Ara-C|Intermediate-risk AML patients with hematological complete remission and positive minimal residual disease (MRD) will receive high-dose of Ara-C (2g/m2 d4-6) consolidation chemotherapy.
15930283|NCT03417401|Procedure|Vitrectomy with retinal vein cannulation and intravenous rtPA (Actilyse) infusion up to 1mg.|Standard 3-port pars plana vitrectomy with surgical stabilizer assisted (mynutia surgical robot) retinal vein cannulation with recombinant tissue Plasminogen Activator (Actilyse-0.25mg/ml) infusion with a maximal dose of 1mg..
15930284|NCT03417401|Drug|Intravenous Infusion|Intravenous infusion in a retinal vein with rtPA (Actilyse 0.25mg/ml).
15930323|NCT03417076|Drug|Bexagliflozin|Bexagliflozin tablets, 20 mg, and bexagliflozin by IV
15930285|NCT03417388|Drug|High dose potent statin|The IMT-assigned women will receive high-dose, potent statin (atorvastatin 40-80 mg/d or rosuvastatin 20-40mg) class of lipid-lowering medications.
15930286|NCT03417388|Drug|ACE-I (lisinopril) or ARB (losartan)|Angiotensin converting enzyme inhibitors (ACE inhibitors) and angiotensin receptor blockers (ARBs) are widely prescribed for primary hypertension.
15930287|NCT03417388|Drug|Aspirin|Will be recommended to IMT women without contraindications or bleeding risk.
15930288|NCT03417388|Behavioral|Lifestyle Counseling|The PACE Lifestyle Assessment Intervention which is a program to assist with smoking cessation, weight loss, and exercise.
15930289|NCT03417388|Behavioral|Quality of Life Questionnaires|Quality of Life Questionnaires will be obtained.
15930290|NCT03417375|Procedure|Bilateral Sinus Augmentation|Lateral window sinus augmentation with core samples harvested from the window following 4 months of healing.
15930291|NCT03417362|Other|Animation|3 minute video describing and explaining early medical abortion, followed by questionnaire
15930292|NCT03417349|Device|Sofia|The SOFIA™/ SOFIA™ PLUS Catheter will be used in removal/aspiration of emboli and thrombi following the CE marked Instructions For Use. Enrollment into the study does not change the routine care at the site provided to the patient requiring mechanical thrombectomy treatment.
15930293|NCT03417336|Radiation|prostatic boost in brachytherapy with high dose rate (HDR)|prostatic boost in brachytherapy with high dose rate (HDR)
15930294|NCT03417323|Other|Compression|Participants in the treatment group wear compression garment after intense WB-EMS application for 24 h, and 12 h for day 2, 3, 4 post WB-EMS.
15930295|NCT03417310|Device|"H joystick"|A joystick that corrects lateral displacement and angulation for multi-direction reduction
15930296|NCT03417310|Procedure|Common reduction methods|Manual reduction methods without the assistance of any devices
15930297|NCT03417297|Device|high intensity focused ultrasound|high intensity focused ultrasound
15930298|NCT03417284|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo HSCT
15930299|NCT03417284|Biological|Filgrastim-sndz|Given SC
15930300|NCT03417284|Drug|Melphalan Hydrochloride|Given IV
15930301|NCT03417271|Device|Deep brain stimulation|The different stimulation pulse widths are made possible by the use of a Medtronic XBP flashcard used with the conventional Medtronic 8840 programmer.
15930302|NCT03417245|Drug|fitusiran|by subcutaneous (SC) injection
15930303|NCT03417245|Drug|factor concentrates|by intravenous (IV) injection
15930304|NCT03417232|Procedure|CAF|The design of the flap consisted of two horizontal beveled incisions (3mm in length) and two slightly oblique beveled incisions. The resulting trapezoidal-shaped flap was elevated in the coronal-apical direction. The suture of the flap started with two interrupted periosteal sutures performed at the most apical extension of the vertical releasing incisions; afterwards, it proceeded coronally with other interrupted sutures, each of them directed, from the flap to the adjacent buccal soft tissue, in the apical-coronal direction. The last sling suture allowed for the stabilization of the surgical papillae over the inter-dental connective tissue bed and allowed for a precise adaptation of the flap margin over the underlying convexity of the crown.
15930305|NCT03417219|Behavioral|Education and Skill Building Rehabilitation-mobile (ESBR-m)|Participants randomized to the ESBR-m group will participate in four, 90-minute group ( 5 participants) sessions. These four sessions are supplemented with a booster session one month following the last intervention session.
15930306|NCT03417219|Behavioral|Usual Care (UC)|"Participants randomized to the UC group will receive supplemental educational materials (e.g., VA Caregiver Support Program; Veterans Crisis Line; National Institute on Aging's Understanding Memory Loss)."
15930307|NCT03417206|Drug|Remifentanil|a rate of infusion will be increased by 50% every 5 minutes until PRD decreases below 5%
15930308|NCT03417206|Device|pupillary dilatation reflex|PRD value will me measured before the start of FESS after 5 minutes of remifentanyl infusion, when PRD sensitivity > 5% , infusion of remifentanyl will be increased by 50% until PRD sensitivity <5% and FESS will be started ; intraoperatively infusion of remifentanyl will be increased by 50% until PRD sensitivity <5%
15930309|NCT03417193|Drug|opioid free Anesthesia vs Opioid based Anesthesia|Compare the opioid based anesthesia with Fentanyl and Remifentanyl to opioid free anesthesia with dexmedetomidine and lidocaine and their effect on postoperative pain.
15930310|NCT03417180|Drug|Remifentanil|a rate of infusion of reminfentanil will be increased by 50% every 5 minutes, until SPI value decreases back to baseline level
15930311|NCT03417180|Device|surgical pleth index|every time SPI value increases by 15 a rate of infusion of reminfentanil will be increased by 50% every 5 minutes
15930312|NCT03417167|Other|US-guided synovial biopsy|Needle Synovial biopsy performed using a Tru-cut® device.
15930313|NCT03417154|Drug|Nivolumab|3mg/kg IV (or if prior alloHSCT, 1 mg/kg) over 30 minutes every 14 days on Days 1 and 15 for up to four 28-day courses.
15930314|NCT03417154|Drug|Stage 1 Arm 1: Low dose Cyclophosphamide (CTX)|Oral cyclophosphamide 50mg + nivolumab 3 mg/kg IV every 2 weeks for up to 4 courses of treatment
15930315|NCT03417154|Drug|Stage 1 Arm 2: Low dose Cyclophosphamide (CTX)|Oral cyclophosphamide 350 mg every 7 days + nivolumab 3mg/kg IV every 2 weeks for up to 4 courses of treatment
15930316|NCT03417154|Drug|Stage 2: Low dose Cyclophosphamide (CTX)|Stage 2: Oral cyclophosphamide as assigned for up to 4 treatment courses with each treatment course equal to 28 days.
15930317|NCT03417141|Drug|Mechlorethamine 0.016% Top Gel|Valchlor, a 0.016% gel formulation of mechlorethamine. Once daily application of Valchlor in decreasing disease activity in patients with Lichen Planopilaris.
15930318|NCT03417128|Behavioral|Peer support|Participants residing in the location selected to be intervene will to form at minimum 4 peer groups. This group will receive a continuous three-months, peer-led nutrition and lifestyle behaviour intervention through a series of peer gathering. Two participants from each peer group will be selected as the peer leader (PL). PL will be trained to deliver the content of PERSUADE modules and will be responsible to run a weekly peer gathering with their respective groups for the following three months.
15930319|NCT03417102|Drug|fitusiran|solution for injection; by subcutaneous (SC) injection
15930320|NCT03417102|Drug|Bypassing agents|solution for injection; by intravenous (IV) injection
15930321|NCT03417089|Procedure|Falciform ligament suspension|routine of falciform ligament suspension during Mini gastric bypass
15930322|NCT03417089|Procedure|no suspension|working without of falciform ligament suspension during Mini gastric bypass
15930324|NCT03417050|Other|No intervention will take place for this retrospective and observational study.|No intervention will take place for this retrospective and observational study.
15930325|NCT03417037|Drug|BMS-986205|Administered orally daily, 100 mg
15930326|NCT03417037|Biological|Nivolumab|Specified dose on specified days
15930327|NCT03417037|Drug|Chemotherapy|Platinum-based doublet chemotherapy
15930328|NCT03417024|Device|Automated Breast Ultrasound|The ABUS system is designed to methodically scan a breast and capture multiple ultrasound images that can be rendered and reviewed in three dimensions.
15930329|NCT03417024|Device|Digital Breast Tomosynthesis|Digital Breast Tomosynthesis (DBT) systems are designed to collect 3-dimensional x-ray images of breast tissues.
15930330|NCT03417011|Device|Medtronic CoreValve™ Evolut™ PRO System (Evolut™ PRO System)|Transcatheter Aortic Valve Replacement with Medtronic Evolut PRO system
15930331|NCT03416998|Other|phototherapy|Phototherapy will be performed using clusters of 12 diodes (Table 1); four 905 nm diodes (mean power of 0.3125 mW and peak power of 12.5 W for each diode; 250 Hz), four 875 nm diodes (mean power of 17.5 mW for each diode) and four 640 nm diodes (mean power of 15 mW for each diode). The device manufactured by Multi Radiance Medical® (Solon, OH, USA) will be used due to its high quality, ample use in clinical practice and due to the fact that no national companies manufacture diode clusters with the characteristics required for the proposed project.
15930332|NCT03416985|Device|Oral B Healthy Clean Manual Toothbrush|Manual Toothbrush
15930333|NCT03416985|Device|BURST Sonic Oral Care|Electric sonic toothbrush
15930334|NCT03416985|Device|Philipps Sonicare DiamondClean 300 Series|Electric pulsating toothbrush
15930335|NCT03416972|Radiation|Standard platinum-based chemoradiotherapy|Stage III patients: Standard platinum-based chemotherapy, total radiation dose 60 Gy in 30 fractions. Stage I/II patients: Standard radiotherapy, total radiation dose of 54 Gy in 3 fractions (peripheral), 55 Gy in 5 fractions (near chest wall), or 60 Gy in 8 fractions (central).
15930336|NCT03416959|Procedure|intramedullary fixation or endoprosthetic reconstruction|Surgical treatment for long bone metastases with intramedullary nail or endoprosthetic reconstruction
15930337|NCT03416946|Device|Visionaire|Custom cutting block using MRI to create patient specific instrumentations
15930338|NCT03416946|Other|Traditional|Traditional cutting method
15930339|NCT03416933|Other|Blood sampling|2x10 ml of patient peripherical blood will be collected at D0, D15, D30, D90, D180, D270 and with progression or at the end of the follow-up at the 12th month.
15930340|NCT03416920|Other|Wellframe|Wellframe mobile phone app
15930341|NCT03416907|Behavioral|Original consent form|Participants will review the full-length, original consent form for the clinical trial.
15930342|NCT03416907|Behavioral|Shortened consent form|Participants will review a shortened consent form for the clinical trial, which includes only material indicated as important by 2/3 of participants from a previous study.
15930343|NCT03416907|Behavioral|Reordered, shortened consent form|Participants will review a reordered, shortened consent form. This form is based on the shortened consent form, but the sections are reordered based on a previous study, such that sentences previously rated as more likely to impact a participant's decision is more likely to be presented first (except for an initial introductory section).
15930344|NCT03416907|Behavioral|Shortened consent form with a highlights box|Participants will review a shortened consent form with a highlights box, where the highlights box includes the 10 sentences rates as most likely to impact a participant's decision from a previous study.
15930345|NCT03416907|Behavioral|Interactive, shortened consent form|Participants will review an interactive, shortened consent form, where hyperlinks to different sections of the consent form are provided. The landing page includes the introductory section.
15930346|NCT03416894|Device|Deep Brain Stimulation|DBS offers the opportunity to insert electrodes into deep brain structures and electrically stimulate them in a titratable and ultimately reversible manner
15930347|NCT03416868|Behavioral|Ambulatory voice biofeedback|Patients will be provided cues regarding their vocal behavior in daily life. Depending on the result of Study 1 in this IRB protocol/NIH grant, The cues will either be: 100% feedback = a vibrotactile cue on a smartwatch every time the patient voices incorrectly... 25% feedback = a vibrotactile cue on a smartwatch every 4th time the patient voices incorrectly... Summary feedback = the patient's overall compliance (percentage of voiced time within desired limits) will be presented via a smartwatch every 2 minutes of voicing.
15930348|NCT03416855|Drug|Insulin degludec /insulin aspart|Commercially available Insulin degludec /insulin aspart (Ryzodeg® FlexTouch®) according to routine clinical practice at the discretion of the treating physician.
15930349|NCT03416842|Device|Training with 4D Motion Capture Device|Participants will be given access to a tablet-based application and non-invasive sensors that will track movements of the upper extremity and will prompt daily exercise. Participants will be encouraged to use the device daily for 30 consecutive days, up to one hour per day.
15930350|NCT03416829|Behavioral|Ambulatory voice biofeedback|Subjects will be provided cues regarding their vocal behavior in daily life. The cues will either be: 100% feedback = a vibrotactile cue on a smartwatch every time the patient voices incorrectly... 25% feedback = a vibrotactile cue on a smartwatch every 4th time the patient voices incorrectly... Summary feedback = the patient's overall compliance (percentage of voiced time within desired limits) will be presented via a smartwatch every 2 minutes of voicing.
15930351|NCT03416816|Drug|DSP-0337|DSP-0337 will be administered at the following doses in dose-escalation cohorts, maximum tolerated dose (MTD) for food effect, and recommended phase 2 dose (RP2D) for dose-expansion cohort. Dose 1: 200 mg once daily, Dose 2: 200 mg twice daily, Dose 3: 400 mg twice daily, Dose 4: 600 mg twice daily, Dose 5: 800 mg twice daily, Dose 6: 1000 mg twice daily.
15930352|NCT03416803|Radiation|Radiotherapy|Radiotherapy
15930353|NCT03416777|Behavioral|Meat-based diet|Diet including 4 servings per week of red meat (1 serving = 150 g), 3 servings per week of processed meat (1 serving = 50 g), and 1 servings per week of poultry (1 serving = 150 g), for a total amount of 900 g per week of meat.
15930413|NCT03416335|Drug|DSP-0509, Pembrolizumab|Each patient treated will receive DSP-0509 at the dose fixed for that Part or cohort administered as a constant rate IV infusion over 10 minutes using a syringe pump and is given in combination with pembrolizumab which should be administered following the dosing schedule of the approved label (200 mg IV q3w)
15930552|NCT03415347|Procedure|Abscess wide local excision|Abscess wide local excision
15930354|NCT03416777|Dietary Supplement|Meat-based diet supplemented with alpha-tocopherol (MBD-T)|Dietary intervention like the MBD with supplementation of alpha-tocopherol at a dosage of 100 mg/die. Available evidence suggests that alpha-tocopherol may help prevent colon cancer by decreasing the formation of mutagens arising from the oxidation of faecal lipids, by decreasing oxidative stress in the epithelial cells of the colon and by molecular mechanisms that influence cell death, cell cycle and transcriptional events (Pierre 2013, Bastide 2016, Bastide 2017, Diallo 2016). It is important to note that 200 mg/day of tocopherol was administered to 20,000 women for 10 years without side effects (Lee et al.,2005).
15930355|NCT03416777|Behavioral|Pesco-vegetarian diet|Diet excluding fresh and processed meat, poultry but including 3 servings per week of any type of fish, excluding shellfish (1 serving = 150 g), for a total amount of 450 g per week. Diet will contain other sources of proteins (e.g. eggs, dairy, legumes/beans). There is suggestive evidence that fish and vegetable consumption has protective effects against CRC (Vieira et al., 2017).
15930356|NCT03416764|Device|EFP-NF training|Experimental groups (among participants with and without steady menstrual cycle) will receive a total of 10 training sessions during 10 weeks. In addition to EFP-NF training, participants in the experimental groups will continue to be treated as usual at Clinic for Sexual Assault.
15930357|NCT03416751|Biological|Fecal Microbial Transplant|Fecal transplant from a donor in the OpenBiome Registry
15930358|NCT03416751|Other|Placebo|Placebo enemas
15930359|NCT03416738|Behavioral|Semantically focused treatment|"Tasks are as follows:
~Semantic feature analysis (SFA): For each pictured stimulus the patient is prompted to name the picture, and then to produce related words that represent features similar to the target word.
~Semantic barrier task: The goal is for one participant (e.g., patient) to describe each card so that the other participant (e.g., clinician) can guess the picture on the card. Participants are only allowed to describe the semantic features of the target and the clinician models the kinds of cues that are allowed.
~Verb network strengthening treatment (VNeST): This treatment targets lexical retrieval of verbs and their thematic nouns. The objective of VNeST is for the patient to generate verb-noun associates with the purpose of strengthening the connections between the verb and its uses.
~These are tasks used in clinical aphasia rehabilitation."
15930360|NCT03416738|Behavioral|Phonologically focused treatment|"Tasks are as follows:
~Phonological (sound) components analysis task: Participants are to name a given picture and then to identify the sound features of the target words (e.g., first sound, last sound, and rhyme).
~Phonological production task: This tasks asks participants to sort and identify the sounds that make up a word. Various stages include identifying first sounds, last sounds, etc. Participants also work on blending sounds together to form words.
~The phonological judgment task: A computerized presentation of verbs and nouns where participants are required to judge whether pairs of words include similar phonological features.
~These are tasks used in clinical aphasia rehabilitation."
15930361|NCT03416725|Device|Otoscope|Otoscopic examination will be done to find the presence or absence of perforation, granulation tissue and cholesteatoma.
15930362|NCT03416712|Other|Screening survey and accompanying handout for resources|Intervention group will be completing a survey of social determinants of health and providing resources based on caregiver responses.
15930363|NCT03416686|Device|Radiofrequency (RF star electrode electrode_Fixed)|"The radiofrequency will be performed under ultrasound control after local anesthesia by a trained operator, after finding the lesion to be treated by the operator.
~Medical device used: RF star electrode electrode_Fixed (Starmed Co,Gyeonggi-do, Korea, French representative Cosysmed)."
15930364|NCT03416673|Procedure|peCTG+CAF|A connective tissue graft will be reshaped to have extensions mimicking the papillae to augment the inter-dental papillae recessed
15930365|NCT03416673|Procedure|CTG+CAF|A connective tissue graft harvested from the palate will be sutured to the gingival recession site and covered with a coronally advanced flap
15930366|NCT03416660|Device|Fractional Carbon Dioxide laser|
15930367|NCT03416647|Procedure|Duodenojejunostomy|Duodenojejunostomy with or without duodenal resection
15930368|NCT03416634|Behavioral|App|The Microsoft Band app can be installed for free on compatible smartphones. The app can be used to track steps while the phone is with the participant (such as in a pocket). Participants can synchronize their device with the study app to give permission to share physical activity level with the study team. Daily physical activity will be tracked for 24 weeks.
15930369|NCT03416634|Behavioral|Wearable Device|A Garmin vivofit 3 fitness device will be provided for free to participants randomized to this study arm. This wearable device tracks daily activity and gives reminders to move after an hour of inactivity. The battery lasts for one year and the device is water resistant. Participants can synchronize their device with the study App to give permission to share physical activity level with the study team. Daily physical activity will be tracked for 24 weeks.
15930370|NCT03416634|Behavioral|Automated Motivational Message|An automated behavioral intervention will be delivered once weekly via an in-app motivational message, over the 12-week intervention period.
15930371|NCT03416634|Behavioral|Personalized Motivational Message|A behavioral intervention will be delivered once weekly via an in-app motivational message adapted to each patient's personalized PA goal progression based on the previous week data from the smartphone activity app (Microsoft band) or the Garmin wearable device over a 12-week intervention period.
15930372|NCT03416621|Behavioral|Cognitive behavioral cessation counseling|Standard smoking cessation plus support text messages
15930373|NCT03416621|Behavioral|Counseling and placebo drug intervention|Enhanced cue exposure treatment (lab-based + interactive SMS texting) + DCS placebo
15930374|NCT03416621|Drug|Counseling and active drug intervention|Enhanced cue exposure treatment (lab-based + interactive SMS texting)+ active DCS. In addition to an in-person, screening visit, we will conduct three in-person treatment visits and an in-person follow-up visit.
15930375|NCT03416595|Dietary Supplement|N1115 Probiotic Supplement|Participators will receive a sachet each day during 8 weeks. The contents of the sachet should be added to warm water or milk, mixed until fully dissolved and served within 15 minutes.
15930376|NCT03416595|Dietary Supplement|placebo|Participators will receive a sachet each day during 8 weeks. The contents of the sachet should be added to warm water or milk, mixed until fully dissolved and served within 15 minutes.
15930510|NCT03415633|Other|Standard Polysomnography (PSG)|Randomizing to start with Standard Polysomnography (PSG)
15930511|NCT03415633|Other|Home Respiratory Polygraphy (APNIA)|Randomizing for therapeutic decision taken with home respiratory polygraphy (APNIA)
15930377|NCT03416582|Behavioral|Symptom Management Education and Nurse Coaching|"The registered nurse (RN) will teach good mouth care and management of sore mouth or throat (mucositis) symptoms to the patient for self-management at home. The RN will then call the patient twice every week to continue educating and coaching the patient about the mucositis self-management. The patient will receive the Symptom Management (SxM) Toolkit which is a written educational guide known as the Cancer Treatment Symptom Management Education Toolkit geared to help the patient manage their symptoms of sore mouth and throat at home in order to prevent dehydration."
15930378|NCT03416582|Behavioral|Drinks Diary|The patient will complete the Drinks Diary daily by recording the all oral fluid ingested and also record the number of times the bathroom is used.
15930379|NCT03416569|Drug|Placebo|placebo skin patch + placebo capsule
15930380|NCT03416569|Drug|Nicotine|nicotine patch (7 mg/24 hrs) + placebo capsule
15930381|NCT03416569|Drug|Prazosin|placebo patch (7 mg/24 hrs) + prazosin capsule (1 mg)
15930382|NCT03416569|Drug|Nicotine + Prazosin|nicotine patch (7 mg/24 hrs) + prazosin capsule (1 mg)
15930383|NCT03416556|Procedure|Mobilization to the glenohumeral joint|The treatment condition consisted on the application of a passive rhythmic AP mobilization to the glenohumeral joint of the affected shoulder. In particular, a Grade III AP glide to the humeral head with the arm positioned in 90º of glenohumeral abduction and full internal rotation was used. The posterior gliding force to the humeral head was applied maintaining the glide at right angles to the plane of movement and at a frequency of 2 Hz which was controlled by means of a metronome. The arm was returned to its original position between each set.
15930384|NCT03416556|Procedure|The manual contact condition|During the manual contact condition the therapist positioned the patient in a mid-range position of glenohumeral abduction and internal rotation and applied the hands to the same contact point as in the treatment condition. However, a simulated posterior glide was performed but with minimal pressure actually applied. The number of repetitions and sets were as per the treatment condition.
15930385|NCT03416556|Other|No-contact condition|During the no-contact condition, the subject remained in the initial starting position thorough the entire session but there was no manual contact between the therapist and the participant. The total treatment time was the same as per the other conditions.
15930386|NCT03416543|Other|Puncture|Puncture necessary for daily practice in patients with acute arthritis of RA or Gout or osteoarthritis
15930387|NCT03416530|Drug|ONC201|ONC201 is a orally active, small molecule DRD2 antagonist that kills cancer cells but not normal cells.
15930388|NCT03416517|Drug|Anlotinib|Anlotinib 12 or 8 mg/d po D1-14 q3w
15930389|NCT03416517|Drug|Irinotecan|Irinotecan 20 or 15mg/m^2/d IV over 60 minutes on days 1-5 and 8-12, q3w
15930390|NCT03416504|Behavioral|Gradual Exposure (EXP-G)|In EXP-G, exposure proceeded hierarchically from mildly, to moderately, to highly intense stimuli so that exposure intensity gradually built between (but not within) sessions.
15930391|NCT03416504|Behavioral|Variable Exposure (EXP-V)|In EXP-V, exposure stimuli were chosen at random (i.e., pieces of paper with exposure stimuli written on them were pulled randomly from an opaque container) so that mild, moderate, and high intensity exposures could occur in any order during any of the sessions (the participant was not informed which level was coming next). This aimed to maximize (a) uncertainty, (b) variability in exposure intensity, and (c) variability in corresponding physiological arousal.
15930392|NCT03416491|Drug|KW-136|KW-136 30 mg was provided in 3 capsules, 10 mg each, and KW-136 60 mg in a single capsule of 60 mg.
15930393|NCT03416491|Drug|Sofosbuvir|Sofosbuvir was provided in a single tablet of 400 mg.
15930394|NCT03416478|Diagnostic Test|ctDNA test|ctDNA test to find some possible mutation.
15930395|NCT03416465|Behavioral|medical questionnaire|The patient will complete a questionnaire of 10 questions before leaving hospital. This questionnaire concerns the care pathway for hospitalized patients.
15930396|NCT03416452|Device|vibratory cueing device|ankle brace with vibrator that provides electric stimulus
15930397|NCT03416452|Device|Mobile Gait Trainer|standard rolling walker that has a battery operated sensor attached to the side, designed to detect footsteps
15930398|NCT03416439|Other|lifestyle intervention|lifestyle intervention program carried out by trained professionals
15930399|NCT03416426|Device|Amplatzer® PFO occluder or Gore® Septal Occluder|The closure procedure was performed under general anesthesia. After achieving femoral venous access, the PFO was crossed with a 5F multipurpose catheter, which was advanced into the left upper pulmonary vein and then exchanged over a 0.035 inch J-tipped stiff guidewire for an 8F or 9F guiding sheath. Procedural anticoagulation was initiated with 5000 units of intravenous heparin. After then additional heparin was administrated throughout procedure to maintain an activated clotting time of ≥250 seconds. Device size was selected based on TEE measurements of the distance between the PFO and the aortic root.
15930400|NCT03416413|Procedure|Ambulatory phlebectomy|Minor surgery to remove varicose vein tributaries
15930401|NCT03416413|Drug|Foam sclerotherapy|Injection of foam sclerosant into varicose vein tributaries
15930402|NCT03416400|Other|Oocyte vitrification|Immature oocytes were collected from patients (≤37 years old, without endometriosis, Polycystic syndrome or other ovulatory desease) who underwent to ICSI. In addition, immature oocytes collected from patient diagnosed with cancer will be included in this study. Oocytes were matured in vitro with IVM medium and vitrified in closed system (Vitrolife). Kinetic of maturation were analyzed by Primovision (Vitrolife) and actin, and spindle organization were studied by microscopy, immunostaining techniques and quantitive analysis.
15930403|NCT03416387|Device|3D PRINTING|A 3D digital image reconstruction and a 3D printing model were performed in all patients with complex liver tumors.
15930404|NCT03416374|Drug|Ixazomib|Ixazomib capsules
15930405|NCT03416374|Drug|Bortezomib|Bortezomib injections
15930406|NCT03416374|Drug|Carfilzomib|Carfilzomib intravenous infusions
15930407|NCT03416374|Drug|Lenalidomide|Lenalidomide capsules
15930408|NCT03416374|Drug|Dexamethasone|Dexamethasone tablets
15930409|NCT03416361|Dietary Supplement|4000IU Vitamin D3|Chewable blackcurrant flavoured tablets (two per day)
15930410|NCT03416348|Drug|Aluminum Chloride 20% (deodorant)|Aluminum Chloride (deodorant)
15930411|NCT03416348|Drug|Alcohol|Placebo
15930412|NCT03416335|Drug|DSP-0509|Each patient treated will receive DSP-0509 at the dose fixed for that Part or cohort administered as a constant rate IV infusion over 10 minutes using a syringe pump.
15930414|NCT03416335|Drug|DSP-0509, Pembrolizumab|Each patient treated will receive DSP-0509 at the Recommended Phase II Dose (RP2D) level as determined in Part B. It is given as a constant rate IV infusion over 10 minutes using a syringe pump and is given in combination with pembrolizumab which should be administered following the dosing schedule of the approved label (400 mg IV q6w)
15930415|NCT03416322|Other|Water exchange|Infusion and remove water during inertion and withdrawal of colonoscope
15930416|NCT03416283|Behavioral|Remote Monitoring|Remote BP monitoring and medication adherence
15930417|NCT03416283|Behavioral|Remote Monitoring + Social Support|"Remote BP monitoring and medication adherence with enhanced support from a support partner (facilitated cheerleading)"
15930418|NCT03416270|Drug|Ertugliflozin|Ertugliflozin Tablets Total Dose 15mg (10mg + 5 mg) once daily for 12 weeks
15930419|NCT03416270|Drug|Placebo|Placebo once daily for 12 weeks
15930420|NCT03416257|Other|No intervention|
15930421|NCT03416244|Drug|Nivolumab|Nivolumab 240 mg IV fixed dose every two weeks
15930422|NCT03416244|Drug|Ipilimumab|Ipilimumab 1mg/kg IV every six weeks (starting in week 7 after safety assessment)
15930423|NCT03416231|Drug|Apatinib|apatinib, at a dose of 250 mg daily,Treatment was continued until disease progression.
15930424|NCT03416231|Drug|Docetaxel|Docetaxel, at a dose of 75mg/m2 on days 1 and 22, repeat every 4 weeks for 4~6 cycles.
15930425|NCT03416218|Behavioral|Prognosis|Prognosis will be a single-player 2D, digital simulation game and supporting multimedia website. Players are situated as a major official of Hexacago, and tasks them with managing the city's finances, education levels, and health concerns to lower rates of teenage pregnancy and sexually transmitted infections. In the game Prognosis, player dispatches professionals from a variety of fields to different neighborhoods around the city, observing the effects of their resource allocation decisions across multiple systems over many in-game months. The supporting multimedia website will house curriculum and learning tools to support the learning objectives of Prognosis.
15930426|NCT03416205|Device|Erbao electric knife|Erbao electric knife is used to cut the Duodenal sphincter
15930427|NCT03416205|Device|Three-cavity incision knife|Three-cavity incision knife is used to cut the Duodenal sphincter
15930428|NCT03416205|Device|Columnar expansion balloon|Columnar expansion balloon is used to expand the the Duodenal sphincter
15930429|NCT03416192|Device|MCO-HD|Measurements will be done after 0,4,8 and 12 weeks of hemodialysis with Medium Cut-Off filter.
15930430|NCT03416192|Device|high-flux HDF|Measurements will be done after 0,4,8 and 12 weeks of hemodiafiltration with standard high-flux filter
15930431|NCT03416179|Drug|glasdegib|"Daily Glasdegib (100 mg, PO), beginning on Day 1 and is to continue up to 2 years post randomization.
~Following consolidation therapy, glasdegib or placebo will be administered daily for up to 2 years after randomization or until they have minimal residual disease (MRD) negative disease, whichever comes first.
~Daily Glasdegib (100 mg, PO) or matching placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy."
15930432|NCT03416179|Drug|daunorubicin + cytarabine|"'7+3' (cytarabine 100 mg/m2, IV for 7 days by continuous infusion and daunorubicin 60 mg/m2 for 3 days).
~If a second induction is needed, Investigators may choose either a 5 day cytarabine continuous infusion plus daunorubicin for 2 days ('5+2') or a 7 day cytarabine continuous infusion plus daunorubicin for 3 days ('7+3');"
15930433|NCT03416179|Drug|azacitidine|Azacitidine (75 mg/m2, SC or IV) daily for 7 days, in 28 day cycles for as long as they do not meet the criteria for disease progression, unacceptable toxicity, consent withdrawal, or death.
15930434|NCT03416179|Drug|Placebo|"Matching placebo (PO) given on Day 1 and is to continue up to 2 years post randomization. Following consolidation therapy, placebo will be administered daily for up to 2 years after randomization or until they have MRD negative disease, whichever comes first.
~Daily placebo will continue throughout Induction(s) and Consolidation therapies regardless of dose modifications/delays in the chemotherapy."
15930435|NCT03416179|Drug|Placebo|Matching placebo (PO) is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment. Subjects will continue placebo until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first.
15930436|NCT03416179|Drug|glasdegib|"Glasdegib 100 mg PO QD is to be administered by mouth daily beginning on Day 1 of chemotherapy and will continue if subjects demonstrate reasonable evidence of clinical benefit and do not meet the criteria for progression regardless of any delays/modifications in the chemotherapy treatment.
~Subjects will continue glasdegib until disease progression, unacceptable toxicity, consent withdrawal, or death, whichever comes first."
15930437|NCT03416179|Drug|cytarabine|Consolidation with single agent cytarabine 3 g/m2 IV for adults <60 years and 1 g/m2 for adults 60 years over 3 BID on Days 1, 3, and 5, every 28 days for up to 4 cycles or alternative single agent cytarabine consolidation schedules may be used per local prescribing information.
15930438|NCT03416179|Procedure|HSCT|If required, and done per standard of care post Induction(s).
15930439|NCT03416166|Device|Transcatheter Tricuspid Intervention|Any available transcatheter tricuspid valve intervention
15930440|NCT03416153|Drug|Carboplatin|AUC=1 weekly during radiation therapy. Carboplatin will be given once a week in combination with paclitaxel (standard treatment), concurrent with radiation therapy. Given IV.
15930441|NCT03416153|Radiation|Radiation Therapy|Patients will initially receive a single prescription of 70 Gy to PTV1 in 35 fractions with RT given once daily, 5 days a week along with weekly carboplatin and paclitaxel (standard therapy). Dose will be reduced to 54Gy to high risk PTV and 43.2Gy to low risk PTV all in 27 fractions for patients who meet pPET-CT and iPET-CT parameters.
15930442|NCT03416153|Drug|Paclitaxel|30 mg/m2 weekly during radiation therapy. Paclitaxel will be given once a week in combination with carboplatin (standard treatment), concurrent with radiation therapy. Given IV.
15930443|NCT03416140|Other|Therapeutic Exercise|30 minutes per day of therapeutic exercise
15930444|NCT03416127|Drug|Propolis|Propolis capsules, 300 mg, two times per day before break-fast and dinner during 12 weeks.
15930445|NCT03416127|Drug|Metformin|Metformin capsules, 850 mg, two times per day before break-fast and dinner during 12 weeks.
15930446|NCT03416127|Drug|Placebo|Calcined magnesium, two times per day before break-fast and dinner during 12 weeks.
15964203|NCT03157089|Drug|Afatinib|Film-coated tablet
15930447|NCT03416101|Procedure|Total Gastrectomy|The esophagus was resected at the arch level of the azygos vein, a frozen section of the resection margin was routinely performed to achieve a proximal clean resection margin. The surgical specimen was comprehensive of distal esophagus, stomach and omentum. Digestive tract continuity was established with Roux-en-Y esophagojejunostomy. Lymphadenectomy was extended to the thoracic stations R 2-4, 7-8-9, and L 4, numbered according to the Mountain's classification [39] (Suppl. File 2 Figure A) and to the abdominal stations 1-12, numbered according to the Japanese Research Society for Gastric Cancer (JRSGC) 1998 classification.
15930448|NCT03416088|Dietary Supplement|water deprivation,water,wine,coffee|The participants drink 300ml wine (alcohol concentration:13%)or 300ml coffee (caffeine concentration 1.2%).
15930449|NCT03416075|Device|Mechanical ventilation|Noninvasive and/or invasive mechanical ventilation were performed when patients had respiratory failure.
15930450|NCT03416062|Drug|Remaxol®|Solution for intravenous infusions, containing succinate, methionine, inosine, and nicotinamide in 400 ml glass bottle
15930451|NCT03416062|Drug|Ringer's Solution|Solution for intravenous infusion, 400 or 800 ml
15930452|NCT03416049|Device|PEMF therapy with a high-power PEMF device|The 20 participants assigned to a high-power PEMF device will treat each Venous Stasis Leg Ulcer (VSLU) area for 10 minutes twice a day.
15930453|NCT03416049|Device|PEMF therapy with a medium PEMF power device|The 20 participants assigned to a medium-power PEMF device will treat each VSLU area for 15 minutes twice a day.
15930454|NCT03416049|Device|PEMF therapy with a low-power PEMF device|The 20 participants assigned to a low-power PEMF device will treat each VSLU area for 30 minutes twice a day.
15930455|NCT03416049|Device|PEMF therapy with the sham PEMF device|The 20 participants assigned to the sham PEMF device will treat each VSLU area for 15 minutes twice a day.
15930456|NCT03416036|Biological|TetraVax-DV-TV003 (TV003)|TV003 contains 10^3.3 plaque-forming units (PFU)/mL of rDEN1Δ30, 10^3.3 PFU/mL of rDEN2/4Δ30(ME), 10^3.3 PFU/mL of rDEN3Δ30/31-7164, and 10^3.3 PFU/mL of rDEN4Δ30. Administered by subcutaneous injection in the deltoid region of the upper arm
15930457|NCT03416036|Biological|rDEN2Δ30-7169 (DENV-2)|Administered at a dose of 10^3 PFU by subcutaneous injection in the deltoid region of the upper arm
15930458|NCT03416036|Biological|rDEN3Δ30 (DENV-3)|Administered at a dose of 10^3 PFU by subcutaneous injection in the deltoid region of the upper arm
15930459|NCT03416036|Biological|Placebo|Administered by subcutaneous injection in the deltoid region of the upper arm
15930460|NCT03416023|Device|TIES® (Transcutaneous Implant Evacuation System)|Transcutaneous Implant Evacuation System
15930461|NCT03416010|Behavioral|COPE-P|"Session 1 ABCs (A=Antecedent or Activator event, B=Belief that follows the event, C=Consequence: how you feel and how you behave).
~Session 2 self-esteem and positive self-talk, including ways to build self-esteem and the group provides examples of how to change unhealthy habits into healthy ones.
~Session 3 stress/coping during pregnancy. Physical and emotional responses to stress are discussed along with healthy snacking and healthy ways to cope with typical stresses.
~Session 4 planning, goal setting and the 4-step problem solving process. Session 5 dealing with emotions in healthy ways through positive thinking and effective communication.
~Session 6 coping with stressful situations encountered during pregnancy while continuing to reinforce the thinking-feeling-behaving triangle."
15930462|NCT03415997|Drug|Iohexol|Iodinated contrast media
15930463|NCT03415984|Diagnostic Test|Color retinography|Color retinography
15930464|NCT03415984|Diagnostic Test|Optical coherence tomography|Optical coherence tomography
15930465|NCT03415984|Diagnostic Test|Fundus autofluorescence imaging|Fundus autofluorescence imaging
15930466|NCT03415971|Procedure|EMG befor denture treatment|
15930467|NCT03415971|Procedure|EMG in a month after termination of treatment|
15930468|NCT03415971|Procedure|EMG in a 3 months after termination of treatment|
15930469|NCT03415945|Device|Cardiac resynchronization therapy (CRT)|All study participants have a clinical indication for CRT and will receive CRT implantation as part of their routine medical care. Additionally, participants will receive temporary left and right ventricular septal pacing electrodes and a temporary PressureWire to investigate the acute hemodynamic effect of left ventricular septal pacing, using patients as their own controls.
15930470|NCT03415932|Behavioral|health education|Health information by a multimodal team
15930471|NCT03415919|Other|no intervention will be given to patients.|samples are collected at the time of a scheduled procedure that is part of normal treatment. This study will not have any impact on the care or treatment the patient receives.
15930472|NCT03415906|Combination Product|sacubitril+valsartan|Combined angiotensin receptor + neprilysin inhibition
15930473|NCT03415906|Drug|valsartan|Angiotensin receptor inhibition alone
15930474|NCT03415880|Behavioral|Interactive workshops LiPAT intervention group|Workshops include practical behavior change strategies and address barriers to movement, awareness of the immediate benefits of movement and implementation-intentions. Participants will be encouraged to cultivate a learning mind-set in order to better tolerate potential set-backs and to apply strategies such as pre-planning their week to incorporate physical activity, engaging their social network, and setting up systems and habits. Participants' progress in changing their physical activity patterns which will be compared and discussed.
15930475|NCT03415880|Device|Wrist-worn feedback physical activity monitor|Participants receive the feedback monitor (Fitbit inspire®; commercially available consumer product (https://www.fitbit.com/inspire)
15930476|NCT03415880|Device|Smartphone application LiPAT|With a cloud-based platform the iHealth data is synchronized with a mobile phone app developed by the research team. The app is designed to help the participant to self-monitor their physical activity levels and includes information on total activity and number of steps taken.
15930477|NCT03415880|Behavioral|Telephone Coaching|participants in the intervention group will receive telephone coaching during the first 3 months of the intervention. Telephone coaching will be conducted twice in the first month and once each in months two and three. The researcher will enquire about the progress with increasing LiPA, about the experiences of applying the strategies discussed during workshops, and about the experience with Fitbit Inspire® and the corresponding app. If needed, the coach will offer suggestions to improve goal adherence.
15930512|NCT03415633|Other|Standard Polysomnography (PSG)|Randomizing for therapeutic decision taken with Standard Polysomnography (PSG)
15930686|NCT03414268|Other|Micronized dHACM|1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM)
15930478|NCT03415880|Behavioral|Workshops control group LiPAT|During the first 6 months of the study (the intervention period) participants in the control group will attend 4 workshops in which the benefits of physical activity and the health-risks of sedentary behavior will be discussed. Additionally, information will be provided on healthy lifestyle for patients with type 2 diabetes.
15930479|NCT03415867|Drug|Glasdegib|A dose escalation/de-escalation design will be applied in successive patient cohorts until identification of MTD (dose range: 25-200 mg OD).
15930480|NCT03415854|Drug|Paricalcitol (Zemplar)|combination therapy
15930481|NCT03415841|Device|mHealth remote monitoring devices|"Blood Pressure and wearable vital signs monitor, Biovotion and Kardia mobile application"
15930482|NCT03415828|Device|Ethanol gel|Intradiscal injection of ethanol gel
15930483|NCT03415828|Drug|Prednisolone acetate|Intradiscal infiltration of steroids
15930484|NCT03415815|Procedure|Surgeries|Radical resection of esophageal cancer
15930485|NCT03415802|Drug|Nab-paclitaxel and S-1|Nab-paclitaxel 120 mg/m2 (D1, D8, q3w) and S-1 (40mg BID for body surface area < 1.25 m2; 50mgBID for body surface area of 1.25-1.5 m2; and 60mg BID for body surface area >1.5 m2; D1-14, q3w)
15930486|NCT03415789|Diagnostic Test|Doppler echocardiogram exam|A complete echocardiographic study will be performed at enrollment. The echocardiographic images will be acquired as clinically recommended. The protocol will include the acquisition of 1) 2D images in parasternal axis long and short axis; 2) 2D and Doppler tissue images in the apical planes of 4, 2 and 3 chambers; 3) Pulsed, continuous and color Doppler M (DCMM) of transmitral LV flow and LV ejection; 4) 3-Chamber apical plane with and without color Doppler; and 5) 3D LV images. DCMM images will be obtained from the apical window using 4 and 5 chamber planes. Blood flow velocity will be obtained using Color and Gray mode in the 3 chamber view during 5-10 beats in apnea.
15930487|NCT03415789|Diagnostic Test|Cardiac Magnetic Resonance|"A cardiac MR will be acquired within 10 days after the enrollment. The protocol includes the following sequences: cine mode of short axis from LV base to apex and 2-3-4 chambers. 3D sequence of late enhancement of inversion-recovery. Images will be acquired after 3 min and 10 min of the administration of a total of 0.2 mmol / kg of Prohance®. Intraventricular thrombosis will be monitored. Phase contrast sequences in three orthogonal planes will be acquired. Morphological parameters of LV function (LVEF), contractility (Wall Motion Score ) and sphericity index will be measured."
15930488|NCT03415789|Diagnostic Test|Brain Magnetic Resonance|A brain MR will be acquired within 10 days after the enrollment. Axial, sagittal and coronal spin echo sequence in T1, axial images in diffusion sequences (DWI), enhanced spin echo T2 and FLAIR (fluid-attenuated inversion recovery) sequences shall be obtained. A cerebral infarction will be positive when finding the presence of a focal lesion of> 3 mm in diameter that meets one of these three characteristics: (1) high signal on isotropic DWI images and low signal on the apparent coefficient map Broadcast (ADC). (2) Cavitary lesion hyperintense on T2, with no signal (or low) in the FLAIR sequence. (3) Hyperintense lesion T2 / T1 hypointense with prior distribution defect known or new in a follow-up study.
15930489|NCT03415789|Diagnostic Test|Coagulation blood test|5 ml of peripheral blood will be obtained for assessment of prothrombotic markers at enrollment.
15930490|NCT03415776|Procedure|Hemodialysis|Renal replacement therapy
15930491|NCT03415763|Drug|Capecitabine|According to the postoperative pathological stage, the present study was designed as a non-inferiority trail for patients with pathological complete response or yp stage I to compare the long-term outcomes of observational group and those receiving 5-fluorouracil. For patients with yp stage II or III, the study aims to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone.
15930492|NCT03415763|Drug|mFOLFOX6 or CAPOX|According to the postoperative pathological stage, the present study was designed as a non-inferiority trail for patients with pathological complete response or yp stage I to compare the long-term outcomes of observational group and those receiving 5-fluorouracil. For patients with yp stage II or III, the study aims to compare the effect of oxaliplatin combined with 5-fluorouracil and 5-fluorouracil alone.
15930493|NCT03415750|Drug|Everolimus|Conversion from Mycophenolate mofetil to Everolimus
15930494|NCT03415750|Drug|Mycophenolate mofetil|Patients will remain in Tacrolimus + Mycophenolate mofetil
15930495|NCT03415750|Drug|Tacrolimus|
15930496|NCT03415737|Other|Questionnaire|Profile Fitness Mapping Neck Questionnaire
15930497|NCT03415724|Procedure|Inferior alveolar nerve block|Inferior alveolar nerve block will be given to patients having irreversible pulpitis in mandibular molars
15930498|NCT03415711|Dietary Supplement|VSL#3®|VSL#3® 450 billion sachets
15930499|NCT03415711|Drug|Mesalamine|Mesalamine 2.4 g/day in once daily administration.
15930500|NCT03415711|Drug|Placebo|sachets with maltose, cornstarch and dioxide
15930501|NCT03415698|Drug|G-CSF|G-CSF will be administered at the dosage of 5 µg/Kg subcutaneously every 12 hr for five consecutive days. four such cycles will be administered at three monthly intervals.
15930502|NCT03415698|Drug|Standard Medical Therapy|Nutritional support, rifaximin, lactulose, bowel wash, albumin, diuretics, multivitamins and antibiotics.
15930503|NCT03415685|Device|PicoPlus laser system|Laser treatment using specific pulse durations and wavelengths for selective pigment photothermolysis.
15930504|NCT03415672|Biological|HBVaxPro|Three doses of HBVaxPro-10μg at 0, 1, and 2 months. The HBVaxPro-10μg vaccines are administered strictly intramuscularly in the deltoid muscle and must not be injected intravascularly.
15930505|NCT03415672|Biological|HBAI20|Three doses of HBAI20 at 0, 1, and 2 months. The HBAI20 vaccines are administered strictly intramuscularly in the deltoid muscle and must not be injected intravascularly.
15930506|NCT03415659|Drug|HWH340 tablet|"single escalating dose study starts from 20 mg as the initial dose until the maximum dose group (520mg) or maximum tolerated dose (MTD) has been reached.
~multiple-dose study conducted on oral HWH340 tablet BID. The DLTs evaluating period is 4 weeks and the safety evaluation period lasts till 4 weeks after drug withdrawal.
~dose-expansion study conducted on oral HWH340 tablet BID in 2 to 4 dose groups. Patients with BRCA mutation OR HRD will be assigned to 2 cohort in each dose group."
15930507|NCT03415646|Other|Erector Spinae Plane Block|erector spinae plane block with double level injection will be administered before the surgery
15930508|NCT03415646|Device|Intravenous Morphine patient controlled analgesia device|24 hour morphine consumption will be recorded
15930509|NCT03415633|Other|Home Respiratory Polygraphy (APNIA)|Randomizing to start with home respiratory polygraphy (APNIA)
15964204|NCT03157089|Drug|pembrolizumab|Solution for infusion
15930513|NCT03415620|Procedure|Music listening|Patient is given an ipod with earphone and with saved playlist of different music genres. Music listening session will be given for 30 minutes before and after surgery. Questionnaires will be asked to fill in. All the earphones will be disinfected following the hospital's infection control guideline.
15930514|NCT03415594|Drug|FE203799 GLP-2 analogue|FE203799 5 mg subQ once weekly
15930515|NCT03415594|Drug|FE203799 Placebo GLP-2 analogue|Placebo subQ once weekly
15930516|NCT03415594|Drug|FE203799 GLP-2 analogue|FE203799 10 mg subQ once weekly
15930517|NCT03415581|Drug|Intranasal Oxycodone|Under each doxazosin maintenance condition the effects of intranasal oxycodone will be assessed in order to determine if doxazosin reduces dependent measures assessing its abuse potential.
15930518|NCT03415581|Behavioral|Cue Session|During the cue exposure session participants are presented with neutral cues followed by drug-related cues. This procedure will allow the investigators to determine whether the study medication affects reactivity to drug-related cues.
15930519|NCT03415568|Dietary Supplement|LCT oil|LCT muffin was provided to the study participants. The LCT muffin was consumed within 15 min, and then 6-h meal tolerance test was conducted. The muffin had approximately 465 kcal, 8.36 g of protein, 17.24 g of fat, and 69.0 g of carbohydrate; among the 17.24g of fat, 15g of fat was LCT.
15930520|NCT03415568|Dietary Supplement|MCDG oil|MCDG muffin was provided to the study participants. The MCDG muffin was consumed within 15 min, and then 6-h meal tolerance test was conducted. The muffin had approximately 465 kcal, 8.36 g of protein, 17.24 g of fat, and 69.0 g of carbohydrate; among the 17.24g of fat, 15g of fat was MCDG.
15930521|NCT03415555|Procedure|Erector Spinae Plane blockade|Before the beginning of the procedure, ESP blockade will be performed under ultrasound control. A single-shot technique will be used with 0.375 % solution of ropivacaine: 0.2 mL per patients' KG. The maximum dose is 40 mL.
15930522|NCT03415555|Drug|Oxycodone|Each patient, before the end of surgery, will be administered i.v. 0.1 mg of oxycodone. PCA with oxycodone (1mg/mL) will be utilized during the postoperative period: 5-minute interval.
15930523|NCT03415555|Procedure|general anesthesia|Each patient will generally anesthetized and endotracheal tube will be inserted
15930524|NCT03415555|Drug|paracetamol|Paracetamol will be given i.v. every 6 hours.
15930525|NCT03415542|Behavioral|Exercise Promotion|Evidence-based techniques (goal-setting, reduced barriers) for increasing exercise behavior
15930526|NCT03415516|Device|Gluma Universal|Adhesive systems
15930527|NCT03415516|Device|All Bond Universal|Adhesive systems
15930528|NCT03415516|Drug|Single Bond2|Adhesive systems
15930529|NCT03415503|Drug|Medox® Anthocyanin capsules|Subjects were orally administered Medox® capsules daily for 12 weeks.
15930530|NCT03415490|Other|Folded technique of self-adherent wrap|Wrapping a piece of self-adherent wrap around the patient's head starting with the opened end on the forehead above the affected eye.The bandage is then firmly but not tightly wrapped around the head twice. Then, after the second circuit, the bandage is brought on the cheek and up over the eye to the forehead, where it was passed between the eyebrows but not wrapped around the head. Instead, the bandage is folded and then first passed back on the cheek of the affected side then back to the forehead a total of four times. Finally, the bandage is wrapped completely around the head once
15930531|NCT03415490|Other|Classic technique of self-adherent wrap|Wrapping a piece of self-adherent wrap around the patient's head starting with the opened end on the forehead above the affected eye.The bandage is then firmly but not tightly wrapped around the head twice. After the second circuit, the bandage was brought below the ear, up over the eye and around the head of the non-affected side and then wrapped around the head in the same manner four times. The bandage is then brought around the head once.
15930532|NCT03415477|Drug|Denosumab (Xgeva)|Denosumab (Xgeva) 120 mg was given subcutaneously (abdomen wall or upper arms) every 4 weeks (Q4W), with a loading dose on both Day 8 and Day15 of the first cycle， perioperatively.
15930533|NCT03415464|Other|Exercise|neuromuscular training
15930534|NCT03415451|Device|Fiberscope-Guided Nasogastric tube insertion|Fiberscope-Guided Nasogastric tube insertion
15930535|NCT03415438|Diagnostic Test|Visual Analogue Scale|intensity of pain perception patients feel
15930536|NCT03415438|Diagnostic Test|posterior capsule tightness|tape measurement for posterior capsule tightness with patients lying at side and horizontally adducting their shoulder.
15930537|NCT03415438|Diagnostic Test|shortness tests for lumbar movements|tape measurement for lumbar movements
15930538|NCT03415438|Diagnostic Test|range of motion tests for lumbar movements|range of motion measurements for lumbar flexion, extension and lateral flexion with goniometer.
15930539|NCT03415438|Diagnostic Test|The thoracolumbar fascia length test|patient sitting straight with shoulders at horizontal plane, both the arms are asked to rotated with primarily spinal rotation. the degree of rotation gives idea about the thoracolumbar fascia length
15930540|NCT03415438|Diagnostic Test|Modify Schober test|tape measurement of spinal flexion between designated regions
15930541|NCT03415425|Other|Current Version of the Influenza Alert|Intervention includes the current version of the Influenza Alert that fires in the electronic medical record if the patient has not received the flu vaccination, as part of usual care.
15930542|NCT03415425|Other|Alternate Modifications of the Influenza Alert|Intervention includes various iterations of the Influenza Alert that fires in the electronic medical record if the patient has not received the flu vaccination.
15930543|NCT03415412|Device|Clearfil Univesal Bond|Adhesive systems
15930544|NCT03415412|Device|IBond Universal|Adhesive systems
15930545|NCT03415412|Device|G-Premio Bond|Adhesive systems
15930546|NCT03415399|Biological|ET190L1 ARTEMIS™ T cells|Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET190L1) ARTEMIS™ expression construct
15930547|NCT03415386|Drug|Combination of antiplatelet drugs and anticoagulants for at least one month|Combination of antiplatelet drugs and anticoagulants for at least one month, such as aspirin100mg qd+clopidogrel75mg qd+warfarin (INR1.8-2.2), aspirin100mg qd+clopidogrel75mg qd+dabigatran110mg bid, aspirin100mg qd+ticagrelor60mg bid+warfarin (INR1.8-2.2), and aspirin100mg qd+ticagrelor60mg bid+dabigatran110mg bid. Transthoracic two-dimensional echocardiography will be done at the 1-month, 3-month and 6-month follow-ups to evaluate the left ventricular mural thrombus and determinate whether the antithrombotic therapy regimen could be regulated to double antiplatelet or anticoagulant+clopidogrel75mg qd/ticagrelor60mg bid.
15930553|NCT03415334|Behavioral|behavioral development for change|"Social Marketing Principles (4 Ps) Product, price, place and promotion
~Communication for Behavior Development Approach 1. Interpersonal communication campaigns (IPC) 2. Mass media and public gathering awareness campaigns 3. Public health awareness campaigns 4. A village hotline and local satellite channel 5. School awareness raising events"
15930554|NCT03415321|Device|Postpartum Mobile Support Application|"Women in the experimental group will use the Postpartum Mobile Support Application during six weeks after birth.
~Women will be evaluated three times in total, one for the first day after birth, second for the seventh day after birth and the last for the sixth week after birth.
~Short messages and calls will be remind of women's Postpartum Mobile Support Application use"
15930555|NCT03415308|Other|Focus Groups|Investigators will use qualitative methods to gather data on the elements associated with the patient perception of implicit bias (e.g. communication, respect, patient-centeredness) to ensure that our selected outcomes reflect the breadth of patients' concerns.
15930556|NCT03415308|Other|Cognitive Interviews|To gather insights from stakeholders regarding how to best refine the design of our existing implicit bias intervention to ensure that we have addressed potential facilitators and barriers to uptake, use, and sustainability
15930557|NCT03415308|Other|Pilot Testing of Implicit Bias Training|Determine the feasibility of delivering the refined implicit bias reduction intervention and assessing patient centered outcomes by giving providers a refined implicit bias training.
15930558|NCT03415295|Other|Plasma TMAO concentration|Plasma TMAO concentrations were determined by stable isotope dilution liquid chromatography with online electrospray ionization tandem mass spectrometry on an AB SCIEX 4500 triple quadrupole mass spectrometer
15930559|NCT03415282|Drug|RVT-501 0.5% topical ointment|RVT-501 0.5% topical ointment twice daily (BID) for 4 weeks.
15930560|NCT03415269|Drug|Ambroxol Hydrochloride|single lozenge of 20mg ambroxol
15930561|NCT03415256|Other|passive vibration|The passive vibration is delivered using a Physio Plate (Domino S.R.L, San Vendemiano, Italy). The frequency delivered is 50 Hz for a total number of ten cycles for a period of ten minutes approximately (one cycle= 60seconds working time with 2 seconds rest time).
15930562|NCT03415256|Other|no passive vibration|The control group will not receive any treatment and continue their usual lifestyle.
15930563|NCT03415243|Drug|Acetaminophen 650mg+Dextromethorphan 20mg+Phenylephrine 10mg|Contents of the sachet will be emptied into a glass bottle and 225 mL of hot, but not boiling water (approximately 90-95°C), will be added to the container and mixed to dissolve the contents of the sachet. The dissolved solution will be allowed to cool to approximately 40 - 50 degree Celsius (°C). After cooling, a small volume (1 to 10 microliters [mcL]) of 99mTc-DTPA (Technetium-99m-diethylene-triamine-pentaacetate will be added to the drug solution in to achieve a maximum of 108 curie(mcCi) i.e.4 megabecquerel [MBq] per individual dose at the time of dosing. The container will be capped and maintained at a temperature between 35-45°C at time of dosing and then participants will be instructed to consume the hot drink entirely within 30 seconds.
15930564|NCT03415243|Drug|Acetaminophen 325mg+Dextromethorphan 10mg+Phenylephrine 5mg|Caplet doses will be prepared by drilling hole of approximately(app.)1millimetre(mm)diameter and app.2-2.5mm deep into individual caplets.99mTc-DTPA(dissolved in normal saline)will be added into hole of each caplet as low volume liquid(0.5-2.0mcL)to achieve maximum of 54 mcCi(2MBq)per caplet at time of dosing(2caplets=108 mcCi[4MBq]dose per assessment visit).Applied liquid will be allowed to air dry,hole to be filled with equivalent powder blend from crushed caplet so drug content will remain constant for all caplets.Caplet will be sealed with appropriate material.Radiolabeled caplets will be packaged as unit doses(2 caplets per container)and maintained at room temperature until administration.Caplets will be swallowed with 225mL of noncarbonated room temperature water within 30 seconds.
15930565|NCT03415230|Other|Therapeutic massage|Massage therapy involves the administration of combinations of specific physical manipulations applied in a systematic way, with varying intensity, direction, rate, and rhythm, to the soft tissues of the body.
15930566|NCT03415230|Other|Sham massage|Sham massage involves only light touch massage in a non systematic way
15930567|NCT03415217|Other|Neighbourhood Team Development Program|The Neighbourhood Team Development Program aims to both enhance team development and resident centredness in LTC. The Program has three components, designed to modify the physical environment, the organization and delivery of services, and the alignment of staff members, to function independently and collaboratively in providing resident-centred care.
15930568|NCT03415204|Other|acupuncture|acupuncture for post operative pain
15930569|NCT03415191|Drug|Ketamine|A bolus dose of ketamine 1 mg/kg intravenously five minutes before surgical incision
15930570|NCT03415191|Drug|Normal Saline|A bolus dose of normal saline 1 mg/kg intravenously five minutes before surgical incision
15930571|NCT03415178|Drug|Alirocumab SAR236553|Pharmaceutical form: Solution for injection Route of administration: Subcutaneous
15930572|NCT03415178|Device|Current auto-injector device (AI)|"Pharmaceutical form:
~Route of administration: Subcutaneous self-administration of alirocumab"
15930573|NCT03415178|Device|New auto-injector device (SYDNEY)|"Pharmaceutical form:
~Route of administration: Subcutaneous self-administration of alirocumab"
15930574|NCT03415178|Drug|Atorvastatin|Pharmaceutical form:tablet Route of administration: oral
15930575|NCT03415178|Drug|Rosuvastatin|Pharmaceutical form:tablet Route of administration: oral
15930576|NCT03415165|Drug|green tea buccal tablet|buccal tablet for 8 hrs 3 times aday
15930577|NCT03415165|Drug|Corticosteroids Topical|kenacort in orabase 4 times aday
15930578|NCT03415152|Drug|Omacor (Omega-3-acid ethyl esters)|Observational study without intervention, Omacor is prescribed in routine manner in accordance with clinical practice and the valid Instruction for Medical Use regarding the dose, duration of therapy, patient population, and therapeutic indication.
15930579|NCT03415139|Drug|Oral Glucose Tolerance Test (OGTT)|A standard OGTT will be performed. During OGTT 75gm of glucose will be given followed by phlebotomy.
15930580|NCT03415139|Drug|2 OGTTs with and without GLP-1|A standard OGTT will be performed and a second OGTT procedure will be repeated on a different day with exogenous GLP-1 infusion.
15930581|NCT03415139|Drug|Hyperglycemic clamp procedure|During the hyperglycemic clamp procedure, D20 will given, followed by phlebotomy.
15930582|NCT03415126|Drug|ASN007: ascending doses|Oral drug for the treatment of advanced solid tumors
15930583|NCT03415126|Drug|ASN007 RD|Oral drug for the treatment of advanced solid tumors
15930584|NCT03415100|Biological|CAR-NK cells targeting NKG2D ligands|The infusion of CAR-NK cells will be performed in the Third Affiliated Hospital of Guangzhou Medical University. Following infusion of CAR-NK cells, interleukin-2 (IL-2) will be injected subcutaneously into some patients to support the in vivo survival of CAR-NK cells. The subject will be observed for any side effects during this time and all the adverse events will be recorded.
15930585|NCT03415087|Procedure|sequential intrathecal injection|intrathecal injection of fentanyl and hyperbaric bupivacaine
15930586|NCT03415087|Drug|hyperbaric bupivacaine|intrathecal injection of intrathecal bupivacaine
15930587|NCT03415087|Drug|fentanyl|intrathecal injection of fentanyl
15930588|NCT03415074|Behavioral|Protein restriction|In both arms the dietary protein intake will be reduced. In the sLPD arm, the protein restriction is more severe and ketoanalogues of the essential aminoacids are offered.
15930591|NCT03415048|Other|No Intervention|
15930592|NCT03415022|Behavioral|computer-based treatment|30 minute sessions of free viewing of faces and listening to music
15930593|NCT03414996|Other|Exercise training|Patients will undergo two weekly exercise training sessions with high-intensity interval training or moderate-intensity continuous exercise training for a period of 12 weeks.
15930599|NCT03414970|Radiation|Radiation Therapy|Undergo RT
15930600|NCT03414970|Other|Questionnaire Administration|Ancillary studies
15930601|NCT03414970|Other|Quality-of-Life Assessment|Ancillary studies
15930602|NCT03414970|Other|Laboratory Biomarker Analysis|Correlative studies
15930603|NCT03414970|Radiation|Hypofractionated Radiation Therapy|Undergo hypofractionated RT
15930604|NCT03414957|Diagnostic Test|Hormonal and biochemical blood tests and ultrasound scanning|Subjects undergo clinical assessment, blood tests and a pelvic ultrasound scan, to determine if they have either PCOS or Metabolic Syndrome or both
15930605|NCT03414944|Radiation|SMART-Brain|"Prescription dose: Gross tumor (PGTV) 40-50 Gy/10 fractions/2 weeks + EBI (PCTV) 30 Gy/10 fractions/2 weeks.
~OARs dose limits: Hippocampus D100%≤10Gy, Dmax≤17Gy,Inner ear: Dmean ≤15Gy."
15930606|NCT03414931|Drug|NMDA|Use of an NMDA enhancer for the treatment of MDD in late life
15930607|NCT03414931|Drug|Sertraline|Use of SSRI as an active comparator
15930608|NCT03414931|Drug|Placebo - Cap|Use of placebo as a comparator
15930609|NCT03414918|Drug|Clarithromycin|Hypertensive patients will be exposed to a single oral dose of 150 mg of roxithromycin. A 150-mg oral dose of roxithromycin should yield peak plasma concentrations of 5-12 mcg/mL14, which are higher than the IC50 measured in vitro (0.18-0.53 mcg/mL).
15930610|NCT03414905|Device|Aspira Catheter|-15.5Fr catheter
15930611|NCT03414905|Procedure|Ultrasound|Standard of care
15930612|NCT03414892|Drug|Globalagliatin Hydrochloride|once daily, oral
15930613|NCT03414892|Drug|Placebo|once daily, oral
15930614|NCT03414879|Drug|Ketamine|While in the semi-setting position, patients will receive nebulization with ketamine 3 mg/kg to be completed with normal saline solution to reach a volume of 6 ml (K group; n=30) for 15 minutes before commencing the awake fiberoptic intubation..
15930615|NCT03414879|Drug|Lidocaine|While in the semi-setting position, patients will receive nebulization with lidocaine 4% 6 ml (L group; n=30) for 15 minutes before commencing the awake fiberoptic intubation
15930616|NCT03414866|Behavioral|EQ-5D-5L QOL questionnaire|Written questionnaire
15930617|NCT03414853|Diagnostic Test|Free text prediction algorithm for appendicitis|A free-text prediction software that predicts the probability of acute appendicitis
15930618|NCT03414840|Drug|Atorvastatin|Patients diagnosed with coronary artery disease by CCTA be enrolled. Among enrolled patients, patients who is indicated to statin treatment according to the current ACC/AHA guideline will be treated with atorvastatin.
15930619|NCT03414814|Drug|Osimertinib 80 MG [Tagrisso]|Osimertinib 80mg once daily until disease progression
15930620|NCT03414801|Other|Allergen Exposure|Subjects will undergo two exposure sessions, one week apart, of up to 1 hour depending on the subject's symptom severity and pulmonary function. During the exposure, subjects will be exposed to cat dander and levels of cat allergen, Fel d1, will be measured using sampling pumps with attached filters.
15930621|NCT03414788|Biological|PF 06687234|Subjects will be given single, intravenous dose of PF 06687234 and [124I]IB PF 06687234 simultaneously
15930622|NCT03414788|Biological|[124I]IB PF 06687234|Subjects will be given single, intravenous dose of PF 06687234 and [124I]IB PF 06687234 simultaneously
15930623|NCT03414775|Other|Nourish|The effects of Nourish on the gastrointestinal microbiome will be compared to the the effects of Pediasure on the gastrointestinal microbiome
15930624|NCT03414775|Other|Pediasure|The effects of Nourish on the gastrointestinal microbiome will be compared to the the effects of Pediasure on the gastrointestinal microbiome
15930625|NCT03414762|Device|PICO Negative Pressure Wound Therapy|The PICO unit is a single patient use, battery-powered, disposable unit that can provide continuous 80 - 125 mmHg negative pressure over a 5 to 7-day therapy period.The dressing is applied to the wound and extra strips are placed over the outside edge to help hold the dressing in place. When the pump is turned on, air is pulled out of the dressing and excess fluid from the wound will start to enter the dressing.
15930626|NCT03414762|Device|Standard Dressing|The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing
15930627|NCT03414749|Procedure|Lower Extremity First (LEF)|The intervention for the LEF group was a non-specific long-axis distraction to the ankle, knee, and hip or shoulder, elbow and wrist provided was at the discretion of the clinic doctor (over 25 years experience).
15930628|NCT03414749|Procedure|Upper Extremity First (UEF)|The intervention for the UEF group was a non-specific long-axis distraction to the shoulder, elbow and wrist provided was at the discretion of the clinic doctor (over 25 years experience).
15930629|NCT03414736|Drug|SAR425899|"Pharmaceutical form: Solution
~Route of administration: Subcutaneous"
15930630|NCT03414723|Drug|Sotagliflozin (SAR439954)|"Pharmaceutical form: tablets
~Route of administration: oral"
15930631|NCT03414723|Drug|Ramipril|"Pharmaceutical form: tablets
~Route of administration: oral"
15930632|NCT03414710|Behavioral|Health education booklet plus video plus brief counseling|Participants in the intervention group will receive a health education booklet, watch a 10-minute video and receive counseling provided by the clinicians
15930633|NCT03414710|Behavioral|Health education booklet only|Participants in the intervention group will only receive a health education booklet
15930634|NCT03414697|Other|Control group|The control group received routine rehabilitation treatments including acupuncture, massage, Bobath therapy, and Vojat therapy.
15930635|NCT03414697|Procedure|UC-MSCs|Injection of umbilical cord-derived mesenchymal stem cells (UC-MSCs) (at least 1×10^7), once every 2 weeks, one course of treatment including two injections within 4 weeks, a total of two courses of treatment.
15930638|NCT03414658|Drug|Vinorelbine|work by interfering with cell division, which leaves the tumor unable to grow and spread
15930639|NCT03414658|Drug|Trastuzumab|trastuzumab induces an antibody-dependent cell-mediated cytotoxicity against tumor cells that overexpress HER2.
15930640|NCT03414658|Drug|Avelumab|monoclonal antibody directed against the human immunosuppressive ligand programmed death-ligand 1 (PD-L1) protein
15930641|NCT03414658|Drug|Utomilumab|Utomilumab is an antibody designed to stimulate the body's immune system to fight cancer cells
15930642|NCT03414645|Biological|CAM-101 10%|fibrinogen-depleted human platelet lysate
15930643|NCT03414645|Biological|Vehicle Control|PlasmaLyte-A, vehicle control, a preservative-free ophthalmic drop
15930644|NCT03414645|Biological|CAM-101 30%|fibrinogen-depleted human platelet lysate
15930645|NCT03414632|Drug|99mTc-PYP|Radioisotope used in the SPECT/CT imaging
15930646|NCT03414619|Behavioral|Cognitive Control Tasks and Script Driven Imagery|All participants will receive a structured diagnostic assessment and complete self-report questionnaires about cognitive factors and anxiety/mood symptoms. They then will complete a battery of neuropsychological executive functioning tasks on the computer, each of which measures a different facet of cognitive control (i.e., response inhibition, cognitive flexibility, and attentional control). Finally, they will be guided through a standardized script-driven imagery paradigm that involves generating and listening to an individualized imaginal script associated with a moderately distressing intrusive thought. Self-report and psychophysiological data will be collected during this exercise.
15930647|NCT03414593|Drug|Ultrasound guided popliteal sciatic nerve block with 0.2% ropivcaine|Ultrasound guided popliteal sciatic nerve block with 0.2% ropivacaine 20ml
15930648|NCT03414580|Procedure|Breath sampling for volatile organic compounds|Acquisition of exhaled breath sample in exhaled air to be analysed by gas chromatography-mass spectrometry
15930649|NCT03414541|Drug|DS102|DS102
15930650|NCT03414541|Other|Placebo|Placebo
15930651|NCT03414528|Diagnostic Test|Diagnostic Test|Analysis of DNA samples of patients with molecularly undetermined PID by whole exome/genome sequencing Transcriptome analysis of patients with molecularly undetermined PID
15930652|NCT03414515|Device|Endovascular intervention|Endovascular treatment with stent or balloon according to current practice
15930653|NCT03414502|Drug|Methotrexate|Starting dose of Methotrexate of 15 mg once a week plus folic acid 1mg. daily.
15930654|NCT03414489|Drug|ABC294640|
15930655|NCT03414476|Other|Hair follicles sampling|The follicles will be collected by lock of 10 hair on the scalp (centro-parietal part), to obtain 40 follicles with epithelial sheath
15930656|NCT03414463|Behavioral|TREAT|A 4-week one-to-one intervention between the clinical RA (cRA) and participant. Comprised of eight sessions, it involves psycho-educational lessons and skill-building exercises to achieve objectives based on the characteristics of alexithymia.
15930657|NCT03414450|Drug|ETC-1907206|ETC-1907206 gelatin capsules will be dosed every other day (EOD) and contain 10 mg or 50 mg of ETC-1907206.
15930658|NCT03414450|Drug|dasatinib|dasatinib tablets at 140 mg will be dosed every day
15930659|NCT03414424|Device|CES at rest|"CES will be delivered at rest at various intensities, in combination with either electrical stimulation over peripheral nerves or magnetic stimulation over the motor cortex.
~This is an experiment designed to measure CES interactions with other central and peripheral nerve circuits."
15930660|NCT03414424|Device|CES plus active hand or wrist movements|"CES will be delivered while the participant performs specific finger or wrist tasks at different degrees of effort.
~This is an experiment designed to detect momentary changes in muscle function."
15930661|NCT03414385|Other|Exercise|Acute bout of aerobic exercise at moderate intensity for 2 hours
15930662|NCT03414372|Behavioral|Tough Talks Online|Those randomized to the online condition will receive information about how to access Tough Talks online and be given their unique log-in and password information and information on how to contact study personnel for any technical issues. Arm 1 participants will have 24-hour access to all of the intervention features and will be able to access the program for additional sessions at any time. Study staff will provide reminders using text or email (participant preference) if they have not accessed the intervention at the specified time intervals.
15930687|NCT03414268|Drug|Saline Injection|Injection of 1mL 0.9% Sodium Chloride Injection, USP
15930688|NCT03414255|Biological|Micronized DHACM|1 mL injection of 40mg Micronized dehydrated human amnion/chorion membrane (DHACM).
15930689|NCT03414255|Drug|Saline Injection|Injection of 1mL 0.9% Sodium Chloride Injection, USP
15930663|NCT03414372|Behavioral|Tough Talks Clinic|Those randomized to the in-clinic condition (Arm 2) will immediately begin the Tough Talks intervention. Study staff will ensure participants are logged on and will also be available to answer technical issues should they arise. After completion, those in this arm will have an in-person follow-up visit scheduled for approximately two weeks. The in-person sessions were adapted to be delivered via Zoom or a similar HIPAA compliant platform due to the COVID-19 pandemic.
15930664|NCT03414372|Behavioral|Standard of Care|Those randomized to the control arm (SOC) will receive a paper-based disclosure informational packet based on available Centers of Disease Control (CDC) guidance. At one-month, all participants will complete an online survey to assess intervention acceptability as well as to assess Social Cognitive Theory (SCT model) constructs.
15930665|NCT03414359|Drug|2% Lidocaine|2% Lidocaine using a combined spinal-epidural (CSE)
15930666|NCT03414359|Drug|3% Chloroprocaine|3% Chloroprocaine using a combined spinal-epidural (CSE)
15930667|NCT03414346|Other|Exclusively ice pack|Each subject will receive an experimental intervention of exclusively 500 grams of crushed ice. The intervention will last 20 minutes, and the order of application, expressed in % of water X ice, will be according to the randomization (realized in the first day). The pack will be wrapped in a band for improvement of the contac area. The subject will be asked to mark his pain level on the visual analogue scale (no pain score of 0 and pain as bad as it could be score of 10) every minute until the total time of the intervention.
15930668|NCT03414346|Other|Ice pack added 10% of water|Each subject will receive an experimental intervention of ice pack added to 50 mL of water. The intervention will last 20 minutes, and the order of application, expressed in % of water X ice, will be according to the randomization (realized in the first day). The pack will be wrapped in a band for improvement of the contac area. The subject will be asked to mark his pain level on the visual analogue scale (no pain score of 0 and pain as bad as it could be score of 10) every minute until the total time of the intervention.
15930669|NCT03414346|Other|Ice pack added 100% of water|Each subject will receive an experimental intervention of ice pack added to 500 mL of water. The intervention will last 20 minutes, and the order of application, expressed in % of water X ice, will be according to the randomization (realized in the first day). The pack will be wrapped in a band for improvement of the contac area. The subject will be asked to mark his pain level on the visual analogue scale (no pain score of 0 and pain as bad as it could be score of 10) every minute until the total time of the intervention.
15930670|NCT03414333|Procedure|RYGB|RYGB is associated with a increase of circulating GLP-1 (up to ten-fold) especially in response to meal ingestion. This increased availability of GLP1 has been claimed to contribute to restoration of some of the beta-cell function.
15930671|NCT03414333|Drug|GLP-1|GLP-1 is an hormone secreted by gut in response to nutrients ingestion.
15930672|NCT03414320|Other|Gathering data|Gathering data about sleep, heart rate, carbohydrate intake, insulin pump, continuous glucose sensor, meals.
15930673|NCT03414307|Procedure|Intracerebral catheter placement|Image guided stereotactic placement of intra-hemorrhage catheters to evacuate intra-cerebral hemorrhage
15930674|NCT03414307|Device|Robot-assisted intracerebral catheter|ROSA is a robotic device with trajectory planning software that can be used to aid in planning multiple trajectories to large, irregular clots, and aids in navigating into and out of the cerebral hematoma with minimum human error.
15930675|NCT03414294|Drug|K-755 Part A (SAD)|Single ascending dose (SAD). There will be 7 cohorts in the Part A. Three quarters of subjects will receive K-755 tablet orally in a double-blind fashion.
15930676|NCT03414294|Drug|Placebo Part A (SAD)|Single ascending dose (SAD). In Part A, one quarter of subjects will receive placebo tablet orally in a double-blind fashion.
15930677|NCT03414294|Drug|K-755 Part B (MAD)|Multiple ascending dose (MAD). There will be 4 cohorts in the Part B. Three quarters of subjects will receive K-755 oral tablet in a double-blind fashion.
15930678|NCT03414294|Drug|Placebo Part B (MAD)|Multiple ascending dose (MAD). In Part B, one quarter of subjects will receive placebo tablet orally in a double-blind fashion.
15930679|NCT03414294|Drug|K-755 Part C (FE)|Food effect (FE). All subjects in Part C will receive K-755 oral tablet both under fed and fasted condition in a open-label, crossover fashion.
15930680|NCT03414294|Drug|K-755 Part D (FE)|Food effect (FE). All subjects in Part D will receive K-755 oral tablet both under fed and fasted condition in a open-label, crossover fashion.
15930681|NCT03414294|Drug|K-755 Part E (MAD)|Multiple ascending dose (MAD). There will be 2 cohorts in the Part E. Three quarters of subjects will receive K-755 oral tablet in a double-blind fashion.
15930682|NCT03414294|Drug|Placebo Part E (MAD)|Multiple ascending dose (MAD). In the Part E. One quarter of subjects will receive placebo tablet orally in a double-blind fashion.
15930683|NCT03414281|Procedure|TMQLB group 1|"The patient is placed in the lateral position. The curved (C1-5) probe of Philip CX50 Ultrasound Scanner is used for scan and located vertical to the iliac crest at the posterior axillary line to find the Shamrock sign. The 22-G needle is then inserted in plane and directed to the QL muscle. After the proper position of the needle tip between the psoas major muscle and the quadratus lumborum muscle is confirmed, 0. 4 ml/kg 0.5% ropivacaine with 1: 200,000 adrenaline is injected into the interfascial plane.
~Followed by IPCA in the first 48h after surgery: morphine boluses: 1.5-2 mg, lockout time :10 min, 1h limitation: 6-8 mg morphine."
15930684|NCT03414281|Procedure|TMQLB group 2|"The patient is placed in the lateral position. The curved (C1-5) probe of Philip CX50 Ultrasound Scanner is used for scan and located vertical to the iliac crest at the posterior axillary line to find the Shamrock sign. The 22-G needle is then inserted in plane and directed to the QL muscle. After the proper position of the needle tip between the psoas major muscle and the quadratus lumborum muscle is confirmed, 0. 6 ml/kg 0.5% ropivacaine with 1: 200,000 adrenaline is injected into the interfascial plane.
~Followed by IPCA in the first 48h after surgery: morphine boluses: 1.5-2 mg, lockout time :10 min, 1h limitation: 6-8 mg morphine."
15930685|NCT03414281|Procedure|TPVB|"The patient is placed in the lateral position, the spinous processes of T10 are identified and marks are made 2cm lateral to the spinous processes. The linear(L12-3) probe of Philips CX50 is placed transversally at the mark to identify the paravertebral space. Then a 22-G needle is inserted in-plane from lateral to medial and advanced until the tip reached the paravertebral space surrounded by the parietal pleura and the superior costotransverse ligament. 0.4 ml/kg 0.5% ropivacaine with 1: 200,000 adrenaline is injected into the paravertebral space of T10.
~Followed by IPCA in the first 48h after surgery: morphine boluses: 1.5-2 mg, lockout time :10 min, 1h limitation: 6-8 mg morphine."
15930690|NCT03414242|Other|Cervical spine musculature|Previously established cervical spine musculature training methodology will be utilized to develop a concussion prevention training program.
15930691|NCT03414229|Drug|Epacadostat|100mg bid days 1-21
15930692|NCT03414229|Drug|Pembrolizumab|200mg/dose Day 1, Q 3 weeks
15930693|NCT03414216|Procedure|Group 1 early offloading surgery|As above.
15930694|NCT03414216|Procedure|Group 2 - off-loading in fiberglass cast|As above.
15930695|NCT03414203|Other|tDCS|Transcranial Current Stimulation equipment consists of an ammeter (measured with current intensity), a potentiometer (voltage controller between the electrodes), a generator (two 9-volt batteries) and two electrodes (anode and cathode). The direct low-amplitude currents released by the electrodes reach the cortex and modify the neuronal potentials.
15930696|NCT03414190|Behavioral|Mobile phone text message|The treatment group will receive the usual discharge treatment, instructions and information for acute coronary syndrome patients as well as the text-messaging intervention. The program will include a variety of topics such as standard follow-up care reminders as well as general self-management and healthy living habits texts. There will be four streams: one for patients who are non-smokers and are free of diabetes; one for current/recent smokers; one for diabetic patients; and one for smoker and diabetic patients. Texts will be sent out 4 times per week for 180 days. All participants in the same stream will receive the same texts in the same order. The usual care group will receive standard discharge treatment, instructions, and information for patients with acute coronary syndrome. They will also receive simple and short text messages related to the importance of trial participation.
15930697|NCT03414177|Other|Asthma Subspecialty Follow-up Visits|Pediatric patients with persistent asthma will be recruited to compare outcomes among patients with follow-up visits managed via telemedicine vs. in-person visits.
15930698|NCT03414164|Dietary Supplement|procyanidine|natural antioxidants
15930699|NCT03414151|Other|Observation|No intervention administered.
15930700|NCT03414138|Behavioral|Mindfulness Training|A well-validated brief mindfulness-based mental training regimen [four sessions; 20 min/session] will be used to teach patients to independently practice mindfulness meditation.
15930701|NCT03414138|Behavioral|Book Listening Control|Study volunteers will listen to four 20 minute blocks of The Natural History and Antiquities of Selborne throughout their interventions.
15930702|NCT03414125|Other|FIT Screening Strategy|"Mailed outreach invitation to complete FIT. FIT Strategy invitation includes: 1) invitation letter, 2) test kit (1-sample FIT, simplified instructions on how to perform the test and return mailer with prepaid postage).
~Up to three live phone reminders from project staff 2 to 3 weeks after the invitation to encourage screening completion.
~Centralized processes to promote guideline-based follow-up."
15930703|NCT03414125|Other|Choice Screening Strategy|"Mailed outreach invitation offering patients the choice to complete either a FIT or schedule a colonoscopy.
~Letter will discuss advantages and disadvantages of FIT vs. colonoscopy but will not recommend a particular test, allowing patients to choose a screening option based on their own preferences. Outreach includes: 1) invitation letter, 2) choice grid 3) telephone number for scheduling colonoscopy, and 4) test kit (1-sample FIT, simplified instructions on how to perform the test and return mailer with prepaid postage).
~Up to three live phone call reminders from project staff 2 to 3 weeks after the mailed invitation to encourage screening completion.
~Centralized processes to promote guideline-based follow-up."
15930704|NCT03414112|Biological|Intranasal oxytocin|oxytocin is a peptide hormone that influences social affiliation
15930705|NCT03414099|Drug|Ketum|Ketum (Mitragyna speciosa) is an indigenous plant of Southeast Asia reported to have medicinal value in traditional culture
15930706|NCT03414099|Drug|Placebo|Placebo drink matched for taste and appereance
15930707|NCT03414086|Other|Healthy Control|Ten healthy adult patients evaluating serum, PBMC's, and RNA.
15930708|NCT03414086|Other|Myositis in Remission|Ten patients (four who have polymyositis, six dermatomyositis) from our database who are followed in the Myositis Center. We will collect serum, PBMC's, and RNA samples will be obtained at baseline and at six months. Remission is defined as a global myositis disease activity score less than or equal to 1 on the MDAAT assessments with no new immunosuppressive drug or glucocorticoid use and no increase in dose of either in the preceding year.
15930709|NCT03414073|Device|Knotted floss technique|The subjects use the knotted floss technique. In this modification of conventional flossing technique, a knot is tied in the floss at any distance in the middle third of the floss length. The floss is inserted past the interdental contact point by the conventional finger flossing technique in the non-knotted area and then during the 'to and fro movement' on the tooth surface cervical to contact point, the knotted area is engaged through the embrasure (Gomes et al 2016)
15930710|NCT03414073|Device|Conventional flossing technique|"The subject will wrap the floss around their middle or index finger and gently slide the floss between the teeth and move it along the gum margin, curved into C shape. After this, they will have to move the floss up and down several times between each tooth without using excessive pressure, finally allowing it out through embrasure."
15930711|NCT03414073|Device|Conventional Interdental Brushing|The subject will gently insert the interdental brush into the interdental area with an inclination akin to the angle of the interdental gums (gingiva), and perform to and fro buccal to lingual movements and a little apico-coronal movement such that the gingiva is not impinged, and finally removing the brush out buccally.
15930712|NCT03414060|Device|Menstrual Cup|
15930714|NCT03414034|Drug|Onvansertib|Onvansertib orally
15930715|NCT03414034|Drug|Abiraterone|Abiraterone orally
15930716|NCT03414034|Drug|Prednisone|Prednisone orally
15930717|NCT03414021|Diagnostic Test|SPECT-CT Scan|Injection of a Tracer and SPECT-CT Scan
15930718|NCT03414008|Drug|BI 1291583|Single dose
15930719|NCT03414008|Drug|Matching placebo: Tartaric acid|Single dose
15930720|NCT03413995|Drug|Rucaparib|Continuous dosing
15930721|NCT03413982|Other|Registry|Patient registry
15930722|NCT03413969|Behavioral|CREATION|The physician-oriented intervention will consist of a two-day weekend retreat that focuses on the application of CREATION Health principles in order to reduce burnout and perceived stress and improve well-being and empathy. There will be one four-hour session about each of the following CREATION Health principles: Choice, Trust, Interpersonal Relationships, and Outlook.
15930723|NCT03413956|Procedure|Surgeries|Surgeries
15930724|NCT03413943|Other|gaze training|Gaze training will consist of gaze tracking and then review of performance or the use of an implicit map to train an expert gaze pattern.
15930725|NCT03413930|Procedure|Transanal total mesorectal excision|Patients undergo transanal total mesorectal excision.（assisted by laparoscopy to control the IMA）
15930726|NCT03413930|Procedure|Laparoscopic total mesorectal excision|Patients undergo Laparoscopic total mesorectal excision.
15930727|NCT03413917|Other|Analysis of genomic markers in uterine atony|No intervention will be performed. We will be analyzing tissue and blood samples only to identify potential association of genomic markers with uterine atony.
15930728|NCT03413904|Procedure|transanal TME|transanal approach to TME in rectal cancer
15930729|NCT03413904|Procedure|laparoscopic TME|laparoscopic approach to TME in rectal cancer
15930730|NCT03413891|Drug|Tranexamic Acid|Mouthwash
15930731|NCT03413891|Other|Placebo|Mouthwash
15930732|NCT03413878|Other|Breathing in the simulated avalanche snow|Breathing in the simulated wet or dry avalanche snow with a small or large air pocket
15930733|NCT03413865|Other|Visits conducted via Telemedicine|Patients will be followed via telemedicine with visits lead by a Pharmacist and a Nurse
15930734|NCT03413852|Device|SQUID non-adhesive liquid embolic agent|AVM embolization using SQUID non-adhesive liquid embolic agent
15930735|NCT03413839|Behavioral|Physiotherapeutic Scoliosis Specific Exercises (PSSE)|Exercises with emphasis on trunk extensor strengthening, and teaching patient better postural strategies in supine, sidelying, sitting, standing, and dynamic movements (walking, squatting), led by a PSSE-trained physical therapist.
15930736|NCT03413839|Behavioral|Conventional Physical Therapy (PT)|Conventional PT includes generalized pelvis, and trunk strengthening, lower extremity (LE) stretching, and use of modalities (ice and heat), iontophoresis and E-Stim.
15930737|NCT03413826|Behavioral|Exercise|The intervention groups will perform aerobic exercise for 12 weeks, expending 3,000 kcal of energy per week.
15930738|NCT03413813|Device|Magmaris|Severe stenosis de novo, in native coronary arteries, treated with percutaneous coronary intervention with scaffold implantation.
15930739|NCT03413800|Drug|Lenalidomide-Dexamethasone-DLI|Lenalidomide (Len) and Dexamethasone (Dex) for 6 months followed by three donor lymphocyte infusions (DLIs)
15930740|NCT03413774|Procedure|vaginal swab|high vaginal and Endocrvical swabs for bacterial, protozoal and chlamydial infection- examined by PCR
15930741|NCT03413748|Procedure|Elective Cesarean Section|lower segment cesarean section
15930742|NCT03413748|Other|Peritoneal irrigation|Irrigation of peritoneal cavity with 500 - 1000 ml of warm normal saline
15930743|NCT03413735|Other|Green Tea Extract|Confections containing green tea extract that will be ingested daily for 4 weeks
15930744|NCT03413735|Other|Placebo|Confections containing no green tea extract that will be ingested daily for 4 weeks
15930745|NCT03413722|Drug|Tacrolimus|The patient's physician will prescribe drug according to standard practice.
15930746|NCT03413722|Drug|Everolimus|The patient's physician will prescribe drug according to standard practice.
15930747|NCT03413709|Other|Family Formation Program|The sample for the treatment group for the impact evaluation will only include fathers who are receiving the full 240 hour FFP program (and not the abbreviated 80 hour program). The treatment group will receive FSC's Family Formation Program, which is a six week, 240 hour program implementing a set of curricula focusing on responsible parenting, healthy relationships, and economic stability and mobility.
15930748|NCT03413657|Procedure|Increase in intrathoracic pressure|Will transiently increase intrathoracic pressure for 60 seconds and monitor for changes in hemodynamics during this time.
15930749|NCT03413644|Diagnostic Test|Flow Cytometry|Immunophenotyping of residual clinical samples tested with ClearLLab diagnostic reagent on a specified Flow Cytometer
15930750|NCT03413631|Behavioral|Prenatal mentalization intervention|
15930751|NCT03413631|Other|Prenatal obstetric treatment as usual|
15930752|NCT03413618|Drug|Rivaroxaban|15 mg b.i.d. for 3 weeks and then 20 mg q.d. up to 6 month
15930753|NCT03413618|Drug|Diosmin|600 mg q.d. for 12 month
15930754|NCT03413618|Other|compression stockings|above knee stocking for 12 month
15930755|NCT03413605|Behavioral|A Multilevel CBPR Intervention|The intervention will be implemented through a group-based education workshop. The education session is a curriculum-based group education; each group will be having about 15-20 participants. All group education sessions will take place at collaborating Viet community partners sites, and delivered in Vietnamese language, with offering of refreshment. We will allow 5-7 minutes for participants to get to know each other and to get comfortable talking to the group. Education will have two major topics--- (a) CDC's standard Clinical Preventive Services Guidelines for adults 50+ (CPS). (b) culturally tailored CRC information discussion.
15930756|NCT03413592|Other|Road-tracking test|Driving with simulator program for SDLP measurement
15930757|NCT03413592|Other|Car-following test|Driving with simulator program for DCV measurement
15930758|NCT03413592|Other|Harsh-braking test|Driving with simulator program for BRT measurement
15930759|NCT03413579|Biological|Nimotuzumab ( h-R3)|Humanized monoclonal antibody
15930760|NCT03413579|Other|Placebo|
15930761|NCT03413566|Other|Clinical diagnosis|A clinical diagnosis of cerebral palsy given by a pediatrician at a habilitation center in Norway.
15930762|NCT03413553|Device|immediate implant|Patient will receive immediate implant alone.
15930763|NCT03413553|Biological|connective tissue graft|patient will receive immediate implant with connective tissue graft and platelet rich fibrin
15930764|NCT03413553|Biological|platelet rich fibrin|patient will recieve immediate implant combined with connective tissue graft and platelet rich fibrin
15930765|NCT03413540|Other|Jump|Drop jump from step
15930766|NCT03413527|Device|rTMS|rTMS Treatment
15930767|NCT03413514|Drug|NACT|SOX: Oxaliplatin 130mg/m2,iv.,d1; S-1 60mg,po.,Bid,d1-14; Repeat every 21 days for n courses.(0<n<8)
15930768|NCT03413514|Procedure|SDM|Making the decision about the cycle of neoadjuvant chemotherapy with shared decision making
15930769|NCT03413514|Procedure|Surgery|Radical surgery with D2 lymph node dissection
15930770|NCT03413514|Drug|ACT|SOX: Oxaliplatin 130mg/m2,iv.,d1; S-1 60mg,po.,Bid,d1-14; Repeat every 21 days for 8-n courses.(0<n<8)
15930827|NCT03413059|Drug|Triamcinolone Acetonide|thoracic epidural triamcinolone acetonide
15930771|NCT03413514|Other|Questionnaire|MAPPIN'SDM questionnaire, the control performance card, the care questionnaire, the decisional conflict questionnaire, the decisional regret questionnaire, the questionnaire of the reason for stopping neoadjuvant chemotherapy
15930772|NCT03413501|Behavioral|MUD-PI|
15930773|NCT03413488|Other|kinesio taping|Apply exercise and kinesio taping for intervention
15930774|NCT03413488|Other|exercise|Apply only exercise intervention
15930775|NCT03413475|Behavioral|quality of life|
15930776|NCT03413462|Drug|HS-25|HS-25 10mg/tablet, 20mg,once daily,for 12 weeks, and then HS-25 20mg once daily for 40 weeks.
15930777|NCT03413462|Drug|Placebo of HS-25|Placebo HS-25 10mg/tablet, 20mg,once daily,for 12 weeks,and then HS-25 20mg once daily for 40 weeks.
15930778|NCT03413449|Diagnostic Test|Frailty model|"Grip strength
~30 second chair sit stand test
~Psoas muscle area
~Six minute walk"
15930779|NCT03413436|Drug|Lobaplatin|at least one cycle adjuvant chemotherapy after esophagectomy
15930780|NCT03413436|Drug|Cisplatin|at least one cycle adjuvant chemotherapy after esophagectomy
15930781|NCT03413423|Behavioral|BAT-CS|All participants will receive one hour standard smoking cessation counseling during their hospitalization for an acute coronary syndrome. Participants will be randomized 1 week after discharge. Those assigned to BAT-CS condition will receive 5 more counseling sessions over the 12 weeks after discharge. The first will be up to one hour and will be conducted in person. The next 4 sessions will occur by phone and will take about 30 minutes. Post-discharge sessions will be focused on smoking cessation and mood management using behavioral activation techniques. Participants will be offered the nicotine patch if medically cleared.
15930782|NCT03413423|Behavioral|Smoking Cessation and Health & Wellness|All participants will receive one hour of standard smoking cessation counseling during their hospitalization for an acute coronary syndrome. Participants will be randomized 1 week after discharge. Those assigned to the Smoking Cessation plus Health and Wellness condition will receive 5 more counseling sessions over the 12 weeks after hospital discharge. The first will be up to one hour and will be conducted in person. The next 4 sessions will occur over the phone and will take about 30 minutes. Post-discharge sessions will be focused on smoking cessation and didactic health and wellness education. Participants will be offered the nicotine patch if medically cleared.
15930783|NCT03413410|Drug|Metoprolol|Patients with acute coronary syndrome take metoprolol during hospital and after discharge in the optimal dosing pathway.
15930784|NCT03413384|Drug|Ceftriaxone|1 g ceftriaxone per day for Day 1, 3, and 5 per cycle on a 2 weekly cycle
15930785|NCT03413384|Other|Placebo|Placebo per day for Day 1, 3, and 5 per cycle on a 2 weekly cycle
15930786|NCT03413371|Drug|paracetamol|in group P patients will receive pre-emptive analgesia using intravenous infusion of acetaminophen in a single dose of 10-15 mg per kg of body weight
15930787|NCT03413371|Drug|0,5 % bupivacaine with of 2% lidocaine|in group BL patients will receive regional peribulbar block using a solution of 0,5% bupivacaine (2,5 ml) with 2% lidocaine (2,5 ml)
15930788|NCT03413371|Drug|1 % ropivacaine with of 2% lidocaine|in group RL patients will receive regional peribulbar block using a solution of 0,75 % ropivacaine (2,5 ml) with 2% lidocaine (2,5 ml)
15930789|NCT03413371|Drug|1 % Ropivacaine|in group R patients will receive regional peribulbar block using a solution of 0,75 % ropivacaine (5 ml)
15930790|NCT03413371|Drug|0,5 % bupivacaine|in group B patients will receive regional peribulbar block using a solution of 0,5% bupivacaine (5 ml)
15930791|NCT03413358|Drug|Sheng Bai oral liquid|"Drug: Sheng Bai oral liquid 40 mL, oral use, thrice daily after screening on the same day in the second course of the chemotherapy.
~Subjects will be treated for 2 courses"
15930792|NCT03413358|Drug|Platinum-based two medicine (carboplatin / cisplatin) .|Using Platinum-based two medicine (carboplatin / cisplatin)
15930793|NCT03413332|Other|E-Talkcare|Women in the intervention group will receive the E-Talkcare web address, a user name, and a temporary password. The participant will be able to read or listen (through audio narration) to instructions on how to complete the intervention in order, though she can freely navigate between web modules. Each module will have an ever-present indicator (showing users' progress) and a link to for users to continue navigating through modules.We will ask participants to complete the full intervention within 3 months after intervention delivery and then complete a 3-month post-randomization interview (T1). The website will remain open for six months after intervention delivery to allow participants to use QPL if they wish. A 6-month post-randomization interview (T2) will then be administered.
15930794|NCT03413332|Other|Usual Care|Survivors randomized to the usual care group will receive care from their doctors as usual, allowing us to compare the intervention against real-world practice to inform next steps. Since we do not know if the intervention will be efficacious, we decided not to provide a delayed intervention to control participants.
15930795|NCT03413319|Drug|ABBV-8E12|Solution for infusion
15930796|NCT03413306|Drug|Eltrombopag|Eltrombopag is an oral mimetic thrombopoietin selectively binding transmembrane and juxtamembrane domains of the thrombopoietin receptor different from the binding site of thrombopoietin. Therefore it does not compete for binding with the native molecule. It is promoting thrombopoiesis and release platelets from mature megakaryocytes. Also it promotes more primitive multilineage progenitors and hematopoietic stem cells to proliferate and differentiate into thrombocytes, erythrocytes and leukocytes.
15930797|NCT03413306|Drug|IST (ATG + CsA)|
15930798|NCT03413293|Diagnostic Test|Diagnosis of bacterial infections|Cultures
15930799|NCT03413280|Drug|Ultrasound guided Rectus sheath block|Ultrasound guided rectus sheath block with 0.25% ropivacaine 34ml around umbilicus
15930800|NCT03413280|Drug|Intercostal nerve block|Ultrasound guided intercostal nerve block with 0.25% ropivacaine 6ml in 7,8,9 th intercostal space
15930801|NCT03413267|Other|Custard|Food matrix: custard (liquid emulsion)
15930802|NCT03413267|Other|Flan|Food matrix: flan (soft gel)
15930803|NCT03413267|Other|Sponge cake|Food matrix: sponge cake (porous and spongy)
15930804|NCT03413267|Other|Biscuit|Food matrix: biscuit (thick and crunchy)
15930823|NCT03413111|Procedure|Modified double wire technique|For experimental arm, a tiny cut of papilla orifice, with the length of 5mm, was performed by sphincterotome before the double wire cannulation.
15930824|NCT03413098|Device|Nasal CPAP mask|Investigative Nasal Mask to be used for OSA therapy
15930825|NCT03413085|Device|soft contact lens|"Group A
~Group B"
15930826|NCT03413059|Drug|Morphine Sulfate|Thoracic Epidural morphine
15930805|NCT03413254|Other|Routine follow-up|Patients visit the outpatient clinic twice a year during the first two to three years and annually thereafter, until five years postoperative. CEA-levels are determined at 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 48 and 60 months after primary resection. Detection of liver metastases with ultrasound or CT is performed at 12, 24, 36, 48 and 60 months postoperative. At 6 and 18 months postoperative, a CT-scan is part of the study protocol, but ultrasound of the liver is allowed for other time intervals during follow-up. Colonoscopy is performed at 12 and 48 months postoperative.
15930806|NCT03413254|Procedure|Second look DLS|Second look DLS is performed within one month from negative CT at 6-9 months (depending last date of adjuvant chemotherapy) and normal CEA. Laparoscopic access to the abdominal cavity is obtained under general anaesthesia, followed by adhesiolysis if necessary. Complete staging is performed, with biopsy of any lesion suspicious of PM, and determining the peritoneal cancer index (PCI) in case of PM. Conversion to laparotomy not allowed for better exposure, but only for intra-operative complications.
15930807|NCT03413254|Procedure|Third look DLS|Third look DLS is performed within one month from negative CT at 18 months and normal CEA. Laparoscopic access to the abdominal cavity is obtained under general anaesthesia, followed by adhesiolysis if necessary. Complete staging is performed, with biopsy of any lesion suspicious of PM, and determining the peritoneal cancer index (PCI) in case of PM. Conversion to laparotomy not allowed for better exposure, but only for intra-operative complications.
15930808|NCT03413228|Other|Questionnaire|An interview to collect some informations will be done: demographic informations, medical history, vaccination against influenza status, symptoms and virological informations. Then, a nasal swab was performed in order to identified the influenza virus.
15930809|NCT03413215|Behavioral|Intensive|"Patients are provided with a BP machine, glucometer and test strips, and instructed how to use either a written or smartphone logbook, photograph their meals and use smartphone apps to measure daily activity. DNEs will contact patients in between visits to reinforce adherence and self-monitoring.
~MSWs will conduct at least 6 face-to-face sessions, at 3 weeks then less frequently, on essential self-care behaviours in people with diabetes: healthy eating; being physically active; monitoring of blood sugar; compliance with medications; problem-solving; healthy coping skills; and risk-reduction behaviour.
~Renal pharmacists will see patients at 2-4 week intervals for 3 months after the first clinic visit, and subsequently every 3-6 months. They will review patient's compliance, laboratory results and home BP, educate patient and titrate antihypertensives to meet BP goal. Physician referrals will be made for severe hypertension or hypotension, or intolerable side effects."
15930810|NCT03413202|Drug|butylphthalide(NBP)|Standard medical care is in accordance with China Guideline for the diagnosis and treatment of acute ischemic stroke (2014), including medical care for vital signs, control of temperature, blood pressure and glucose, improving cerebral blood circulation, antiplatelet treatment and nutritional supportive care.In addition, 25mg butylphthalide(NBP) injection, and 100ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, infusion for 14 days, then, butylphthalide(NBP) capsule for 76 days.
15930811|NCT03413202|Drug|placebo|Standard medical care is in accordance with China Guideline for the diagnosis and treatment of acute ischemic stroke (2014), including medical care for vital signs, control of temperature, blood pressure and glucose, improving cerebral blood circulation, antiplatelet treatment and nutritional supportive care.In addition, 100ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, infusion for 14 days, then, starch capsule for 76 days.
15930812|NCT03413189|Other|Review of medical records|Medical records of patients will be reviewed to establish the median and highest level of functional achieved in Intensive Care (intensity) and the percentage of exercise sessions performed (frequency)
15930813|NCT03413189|Other|Assessment of physical and cognitive function|This will be performed in person through the Function Independence Measure (FIM), grip strength, functional reach, 6-minute walk test (6MWT) and Montreal Cognitive Assessment (MoCA-Blind).
15930814|NCT03413189|Other|Interview of patients, carers and/or family members|Questions will be asked to participants regarding their recovery from Intensive Care to establish themes
15930815|NCT03413176|Drug|Cardiac complication induced by VEGF/VEGFR inhibitor|Case reported in the World Health Organization (WHO) of cardiac complication of patient treated by AAs, with a chronology compatible with the drug toxicity
15930816|NCT03413163|Drug|Ultrasound guided erector spinae plane block|A high-frequency linear ultrasound transducer will be placed in a longitudinal parasagittal orientation 3 cm lateral to T9 spinous process. The erector spinae muscles will be identified superficial to the tip of T9 transverse process. The patient's skin will be anesthetized with 2% lidocaine. A 17-gauge 8-cm needle will be inserted using an in-plane superior-to-inferior approach to place the tip into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process. A total of 30 mL of 0.375% bupivacaine will be injected (maximum of 3mg/kg).
15930817|NCT03413163|Other|Standard Pain Followup and Monitorization|Numeric Rating Scale (NRS) pain score will be recorded from 20th minute in recovery room followed by 1.-3.-6.-12.-18.-24.hours. Intravenous meperidine administration at 0.5 mg / kg rescue analgesia was determined in patients with a NSR score of 6 and over in the postoperative collection room. It is planned that the patient will continue to follow the hourly NRS score in ward. Intramuscular diclofenac will be administered in this period if NRS 6 and if it is over, intravenous 0.5 mg / kg meperidine will be administered if NRS score is 6 or more after 2 hours. Salvage analgesic needs and times will be noted in detail, and the use of rescue analgesics, as well as NRS scores at designated hours, will be kept in a statistical evaluation.
15930818|NCT03413150|Drug|Amiodarone|Data were extracted from the files of 80 consecutive critically ill patients who had received at least one dose of amiodarone to treat or prevent AT during their hospitalization in the ICU.
15930819|NCT03413137|Procedure|Transperineal mpMRI-US Fusion prostate biopsy|mpMRI-US Fusion prostate biopsy in a transperineal approach to direct the needles towards an area in the prostate that was found as suspicious of malignancy by previous MRI imaging, defined as region of interest (ROI).
15930820|NCT03413137|Procedure|Transrectal mpMRI-US Fusion prostate biopsy|using the same system and MRI imaging, a transrectal approach would be used to sample a few more cores from the ROI as defined by the MRI imaging.
15930821|NCT03413124|Drug|MGL-3196 Tablet|MGL-3196 in Tablet form
15930822|NCT03413124|Drug|MGL-3196 Capsule|MGL-3196 in Capsule form
15930828|NCT03413046|Diagnostic Test|Peripheral and bone marrow sampling|We obtained blood from peripheral and bone marrow sampling. Then we analyze Treg population and Treg related cytokines with flow cytometry and ELISA methods.
15930829|NCT03413033|Other|Resonance tube|Participants will phonate into a tube (10cm length 4mm inner diameter) during 5 minutes. They will produce series of the vowel /u/ into the tube. They will be asked to maintain the same pitch and loudness as they did in the baseline samples. They will be perceptually controlled by experimenters. When performing the exercise, the participants will be instructed to phonate with ease voice and to sense vibrations in the anterior face and the mouth.
15930830|NCT03413033|Other|Tongue trill|Participants will produce series of a similar /r/ Spanish sound during 5 minutes. They will be asked to maintain the same pitch and loudness as they did in the baseline samples. They will be perceptually controlled by experimenters. When performing the exercise, the participants will be instructed to phonate with ease voice and to sense vibrations in the anterior face and the mouth.
15930831|NCT03413020|Drug|esomeprazole|proton pump inhibitor
15930832|NCT03413020|Drug|bismuth Potassium Citrate|gastric mucosal protective drug with anti-H. pylori effect
15930833|NCT03413020|Drug|amoxicillin|antibiotic for H. pylori eradication
15930834|NCT03413020|Drug|clarithromycin|antibiotic for H. pylori eradication
15930835|NCT03413020|Drug|metronidazole|antibiotic for H. pylori eradication
15930836|NCT03413020|Drug|levofloxacin|antibiotic for H. pylori eradication
15930837|NCT03413007|Diagnostic Test|Immune compleX Predictive Index|iXip is an algorithm thant integrates PSA, PSA-IgM, prostate volume and age of the patient in order to provide the probability of prostate cancer
15930838|NCT03412994|Drug|Apatinib|Apatinib in combination with standard second-line chemotherapy for advanced colorectal cancer
15930839|NCT03412994|Drug|standard second-line chemotherapy|The second line standard chemotherapy regimen recommended by the NCCN
15930840|NCT03412981|Other|pregnant mothers|we will be collecting data on a cohort of pregnant mothers
15930841|NCT03412968|Procedure|Polysulfone Filter|The intervention for this group consisted using a Polysulfone filter in order to hemofiltration in the procedure involving Cardiopulmonary Bypass (CPB).The perfusionist's role is essential during the procedure, as they control both Cardiac Output (CO) and gas exchange, depending on their action, will affect blood lactate levels.
15930842|NCT03412968|Procedure|Procedure/ Surgery: without Polysulfone Filter|In this group, no intervention is performed during the procedure involving Cardiopulmonary Bypass (CPB)
15930843|NCT03412955|Drug|Eribulin Mesylate|1.4mg/m2/dose on days 1 and 8 of a 21-day treatment cycle.
15930844|NCT03412942|Device|FISH SP|The device will be used to close the femoral artery after angiogram and/or endovascular procedure.
15930845|NCT03412929|Device|Honey Impregnated Dressing|The investigational product being examined contains 100% Manuka honey and is ideal for difficult to dress wounds. The dressing provides a moist wound environment to help promote autolytic debridement. The dressing is ideal for partial or full thickness wounds with moderate-to-heavy drainage.
15930846|NCT03412916|Behavioral|GetActive|GetActive is a comprehensive, multimodal treatment that was designed to increase quality of life, resiliency and ability to cope with medical symptoms and stress. This program is rooted in the elicitation of the relaxation response, a non-judgmental state of focused attention and increased awareness.
15930847|NCT03412916|Behavioral|Get Active with Fitbit|The GetActive Program for Pain with a Digital Monitoring Device (GetActive Fitbit) is identical to the GetActive with the addition of a FitBit for recording of physical activity.
15930848|NCT03412890|Drug|Relugolix|Relugolix 40-mg tablet administered orally once daily
15930849|NCT03412890|Drug|Estradiol/norethindrone acetate|Capsule containing co-formulated tablet of E2 (1.0 mg) and NETA (0.5 mg) administered orally once daily
15930850|NCT03412877|Drug|Cyclophosphamide|Days -7 and -6: Cyclophosphamide 60 mg/kg/day x 2 days IV in 250 mL D5W infused simultaneously with mesna 15 mg/kg/day over 1 hour x 2 days.
15930851|NCT03412877|Drug|Fludarabine|Days -7 to -3: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
15930852|NCT03412877|Drug|Aldesleukin|Aldesleukin 720,000 IU/kg IV over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 4 days (maximum 10 doses). Patients in cohort 3 may receive 72,000 IU/kg IV.
15930853|NCT03412877|Biological|Individual Patient TCR-Transduced PBL|Day 0: Cells will be infused intravenously on the Patient Care Unit over 20-30 minutes (2-4 days after the last dose of fludarabine)..
15930854|NCT03412877|Drug|Pembrolizumab (KEYTRUDA )|Arm 2: Pembrolizumab 2 mg /kg IV over approximately 30 minutes on Days -2, 21, 42, and 63.
15930855|NCT03412851|Other|A Direct Aspiration First Pass Technique|Distal aspiration technique
15930856|NCT03412851|Other|Stentriever Thrombectomy|Thrombectomy with stent retriever
15930857|NCT03412838|Procedure|graft surgery|A graft surgery using bone allogenic blocks that are screwed over the atrophic sites of the maxilla to obtain bone augmentation to support dental implants
15930858|NCT03412825|Dietary Supplement|Egg supplementation|Participants will required to consume 2 eggs per day, 5 days a week (a total of 10 eggs per week).
15930859|NCT03412812|Radiation|Dose Escalated Five Fraction Stereotactic Radiosurgery|As focal radiation techniques are utilized more frequently in the treatment of brain metastases, there is increasing need to accurately define the appropriate patient and tumor characteristics for focal therapy. Unfortunately, not all patients are good candidates for single fraction stereotactic radiosurgery (SRS) since large tumors and those in unfavorable locations have been associated with unacceptable rates of treatment-related toxicity. Five fraction stereotactic radiation has proven to be a more effective treatment for these patients that aren't good candidates.
15930860|NCT03412799|Drug|SBP-101|Administered as subcutaneous (SC) injection, escalating dose cohorts
15930861|NCT03412799|Drug|nab-paclitaxel|Administered as intravenous (IV) infusion
15930862|NCT03412799|Drug|Gemcitabine Injection|Administered as intravenous (IV) infusion
15930863|NCT03412786|Biological|Bcl-Xl_42-CAF09b vaccine|The vaccine consists of 0.05 mg peptide (bcl-xl_42) and 625 μg DDA, 125 μg MMG og 31 μg Poly I:C (CAF09b) mixed in a 0.5 ml emulsion
15930864|NCT03412773|Drug|Tislelizumab|200 mg once every 3 weeks (Q3W), intravenous dosing (IV)
15930865|NCT03412773|Drug|Sorafenib|400 mg twice daily (BID), oral dosing
15930866|NCT03412760|Diagnostic Test|Exome sequencing|Expansive genetic test performed for affected fetus or neonate.
15930867|NCT03412747|Drug|Bimekizumab|Subjects will receive bimekizumab at pre-defined timepoints in dose regimen 1 and/or dose regimen 2.
15930868|NCT03412747|Drug|Adalimumab|Adalimumab will be administered according to the labeling recommendations.
15930869|NCT03412747|Other|Placebo|Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products (IMP).
15930870|NCT03412734|Drug|Chlorhexidine|Chlorhexidine preparation solutions
15930871|NCT03412734|Drug|Iodine|Iodine-based preparation solutions
15930872|NCT03412721|Procedure|Laser analgesic procedure|"Water mist spray set to maximum, non-contact handpiece with sapphire tip. Tip-to-tissue distance 10 mm from the tooth neck, achieved by using a spacer. Energy is delivered to the enamel above the gingival margin adjacent to the cemento-enamel junction (perpendicularly towards the dental pulp) on each of the four line angles of the tooth for 30s, moving the laser handpiece in a sweeping action. Pulse energy - 0.2 W/ 10 Hz/ 20 mJ. Follows increase of energy and repetition of protocol - 0.6 W/ 15 Hz/ 40 mJ. Total duration of LA-induction - 240s."
15930873|NCT03412721|Procedure|Placebo analgesic procedure|Performing imitation of laser analgesic procedure. No pulse energy applied, non-contact handpiece with sapphire tip. Moving the laser handpiece in a sweeping action towards the cemento-enamel junction (pointing perpendicularly towards the dental pulp) on each of the four line angles of the tooth. Total duration of placebo analgesia induction - 240s.
15930874|NCT03412708|Other|Vestibular Rehabilitation supported with Virtual Reality|Patients will perform the supervised vestibular exercises in virtual reality environment using a virtual reality goggle (Samsung Gear VR SM323) and a smartphone (Samsung Galaxy S7). The virtual environments consist of 2 media provided by the videos taken with a 360 camera (Samsung Gear 360). 1) A square with people moving, noise and traffic and 2) A supermarket where the shelves are full.
15930875|NCT03412695|Device|MyFood|Patients included in the intervention group will use the MyFood app to record their dietary intake. Nurses will use the report and recommendations in the MyFood tool to follow up the nutritional treatment of the patients.
15930876|NCT03412682|Drug|Budesonide (6 mg)|Budesonide (6 mg) administered once a day along with three mesalazine placebo three times a day, over an 8-week treatment period.
15930877|NCT03412682|Drug|Budesonide (9 mg)|Budesonide (9 mg) administered once a day along with three mesalazine placebo three times a day, over an 8-week treatment period.
15930878|NCT03412682|Drug|Mesalazine (3,600 mg)|Mesalazine (3,600 mg) administered once a day plus three mesalazine 400 mg three times a day, over an 8-week treatment period.
15930879|NCT03412669|Other|Supporting Addiction Affected Families Effectively|Counselling
15930880|NCT03412669|Other|Enhanced Usual Care|Information sheet
15930881|NCT03412656|Device|SoftHand Pro with CUFF force feedback device|Participants will complete various movement and activity of daily living (ADL) assessments to test the effectiveness of the CUFF device in combination with the Soft Hand Pro (SHP) in conveying haptic force feedback to patients with transradial limb loss, and to assess the extent to which the grip force feedback improves the embodiment of the prosthetic device.
15930882|NCT03412643|Drug|Doxorubicin|60 mg/m2 IV Day 1 every 2 weeks or 3 weeks at investigator's discretion for a total of 4 cycles
15930883|NCT03412643|Drug|Cyclophosphamide|600 mg/m2 IV Day 1 every 2 weeks or 3 weeks at investigator's discretion for a total of 4 cycles
15930884|NCT03412643|Drug|Weekly Paclitaxel|80 mg/m2 IV weekly for 12 doses
15930885|NCT03412643|Drug|Trastuzumab|loading dose of 8 mg/kg IV; then 6 mg/kg IV every 3 weeks for Cycles 2-4
15930886|NCT03412643|Drug|Pertuzumab|loading dose of 840 mg IV; then 420 mg IV every 3 weeks for Cycles 2-4
15930887|NCT03412643|Diagnostic Test|Celcuity CELx HSF|Prior to drug interventions 3, 4,and 5, the Celcuity CELx HSF diagnostic test will be conducted to assess HER2 signaling activity
15930888|NCT03412630|Radiation|Computed Tomography Perfusion Imaging|Undergo computed tomography perfusion imaging
15930889|NCT03412604|Device|Transcranial Alternating Current Stimulation (tACS)|tACS will be applied at a frequency of 40Hz and targeting the area of maximal tracer uptake on amyloid PET imaging using an individualized multielectrode design to maximize the induced electrical current to the target region.
15930890|NCT03412591|Drug|Suvorexant 20 mg|Suvorexant 20 mg is an orexin 1/2receptor antagonist approved for the treatment of sleep disturbance in subjects with Primary Insomnia.
15930891|NCT03412578|Procedure|Massage Therapy|Massage therapy was started at corrected gestational age of 35 weeks and continued for 5 consecutive days. The protocol of massage therapy was performed as been described by Tiffany Field (Field, Schanberg et al. 1986). Three consecutive, 15 minutes, sessions were performed daily after the noon feeding. Each treatment session was divided into 5 minutes of tactile stimulation, followed by 5 minutes of kinaesthetic stimulation, and then another 5 minutes of tactile stimulation (Field, Diego et al. 2006).
15930892|NCT03412565|Drug|Daratumumab|Daratumumab will be administered at a dose of 1800 mg by SC injection in Cycles 1 to 4 in D-VRd cohort and until documented progression of disease, unacceptable toxicity, or end of study for D-VMP, D-Rd and D-Kd cohorts.
15930893|NCT03412565|Drug|Bortezomib|Bortezomib will be administered as 1.3 mg/m^2 SC injection in Cycles 1 to 4 in D-VRd cohort and in Cycles 1 to 9 in D-VMP cohort.
15930894|NCT03412565|Drug|Lenalidomide|Lenalidomide will be administered as 25 mg capsule orally in Cycles 1 to 4 in D-VRd cohort and in all Cycles until documented progression of disease, unacceptable toxicity, or end of study in D-Rd cohort.
15930895|NCT03412565|Drug|Dexamethasone|Dexamethasone will be administered as 20 mg orally or intravenously in Cycles 1 to 4 in D-VRd cohort; 40 mg orally or intravenously in all cycles and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Rd and D-Kd cohort.
15930896|NCT03412565|Drug|Melphalan|Melphalan will be administered as 9 mg/m^2 orally in Cycles 1 to 9.
15930897|NCT03412565|Drug|Prednisone|Prednisone will be administered as 60 mg/m^2 orally in cycles 1 to 9.
15930898|NCT03412565|Drug|Carfilzomib|Carfilzomib will be administered as 20 mg/m^2 IV on Day 1 of Cycle 1 only then 70 mg/m^2 IV on Days 8 and 15 of Cycle 1 and Days 1, 8 and 15 of Cycle 2 and thereafter until documented progression of disease, unacceptable toxicity, or end of study in D-Kd cohort.
15930899|NCT03412552|Drug|MgSO4|Loading dose of magensium sulphate (4-6g I.V), given over 20 minutes in 100 ml of dextrose, Maintenance dose (4-6g) magensium sulphate in 500 cc dextrose given over 8 hours using continuous IV drip
15930900|NCT03412526|Drug|Fludarabine|Reduced intensity, myeloablative, lymphodepleting regimen (25 mg/m2 for 3 days)
15930901|NCT03412526|Radiation|Radiation|Total Body Radiation (TBR) (2 Gray in a single treatment) for 1 day
15930902|NCT03412526|Biological|TIL administration|TIL Administration
15930903|NCT03412526|Drug|IL-2|bolus high-dose (720,000 IU/kg) IL-2 is administered to the patients every 8 hours, to tolerance. A maximum of 10 doses are given to the patients.
15930904|NCT03412513|Drug|Mirabegron|Mirabegron 50mg po daily for 12 weeks to Active Comparator group, and 4 weeks(from visit 4 to visit 5) to Placebo comparator group.
15930905|NCT03412513|Drug|Placebo|Placebo po daily for 8 weeks to Placebo comparator group.
15930906|NCT03412500|Drug|Vancomycin equation-based method|Vancomycin dosage will be adjusted according to the equation-based method
15930907|NCT03412500|Drug|Vancomycin trough concentration method|Vancomycin dosage will be adjusted according to the trough concentration method
15930908|NCT03412487|Procedure|laparoscopy|under general anesthesia. CO2 pneumoperitoneum, the laparoscope inserted through the umbilicus and a thorough evaluation of the abdominal cavity and pelvis was performed. a grasper was inserted; the utero-ovarian ligament was stabilized with the round biopter will be introduced. The tip of the biopsy instrument was placed on an area of the ovary free of cysts; the hilar area was avoided because it is deficient in small follicles. After correct placement was verified, the inner protecting trocar was removed to expose the sharp leading edge of the round sheath. Gentle circular movements were made cutting through the ovarian cortex to produce a 5-mm disk of 2-3 mm in thickness.
15930909|NCT03412474|Drug|Bupivacaine|"The study drugs will be prepared by an anesthesiologist not involved in performing the block, patient care or in data collection. Patients will be randomly allocated into two groups of 40 patients each:
~Group A: will receive 0.2 ml/kg/side of bupivacaine (0.125%)."
15930910|NCT03412474|Drug|Dexmedetomidine|Group B: will receive 0.2 ml/kg/side of bupivacaine (0.125%) + 0.5 µ/kg of dexmedetomidine.
15930911|NCT03412474|Drug|paracetamol|paracetamol
15930912|NCT03412461|Other|Thought Spot|Thought Spot is a mobile app and website. This digital platform was designed and produced in partnership with transition aged youth in post-secondary education. The platform maps out wellness and mental health services across the Greater Toronto Area.
15930913|NCT03412461|Other|Resource Pamphlet|The resource pamphlet that participants will be given will include information on the mental health and wellness services available at their respective post-secondary institution.
15930914|NCT03412448|Other|observation|Observation,
15930915|NCT03412422|Diagnostic Test|fluid responsiveness assessment|During the procedure, the investigator will be imaging one of the carotid arteries with ultrasound. In expiratory phase, four sets of three video loops will be recorded: before and after PLR and then before and after fluid challenge. There also will be noted hemodynamic parameters measured with PiCCO monitor. The fluid challenge is defined as administration of 500ml of crystalloid in less than 10 minutes. Later, another investigator, who will be blinded to other data, will measure the maximal and minimal diameter of CCA in each loop. The measurements will be averaged and eventually two values (maximal an minimal) from each set will be obtained.
15930916|NCT03412409|Drug|Cytarabine|RIC preconditioning regimen consisted of cytarabine (2 g/m2/day, days -10 to -9), busulfan (3.2 mg/kg/day on days -8 to -6), cyclophosphamide (1.0 g/m2/day, days -5 to -4), fludarabine (30 mg/m-2/day, days -6 to -2), semustine (250 mg/m-2, day -3), and rabbit antithymocyte globulin (thymoglobulin, 2.5 mg/kg/d, days -5 to -2; Sanofi, France).
15930917|NCT03412396|Drug|Apalutamide|Given PO
15930918|NCT03412396|Other|Quality-of-Life Assessment|Ancillary studies
15930919|NCT03412396|Procedure|Radical Prostatectomy|Undergo radical prostatectomy
15930920|NCT03412383|Drug|Pyrotinib|Pyrotinib 400mg/day
15930921|NCT03412370|Other|Cognitive Assessment|Complete cognitive assessments
15930922|NCT03412370|Other|Questionnaire Administration|Complete questionnaires
15930923|NCT03412357|Procedure|pleurectomy/decortication|"VAT-PD is a type of keyhole surgery performed under general anaesthesia using a telescope and instruments put inside the chest. Through small incisions, or keyholes made between the ribs, the thoracic surgeon removes the hard rind of the tumour over the surface of the lung, thereby allowing the 'trapped' lung to fully expand again. Simultaneous removal of mesothelioma from the outer pleural membrane allows pleurodesis to occur."
15930924|NCT03412357|Procedure|indwelling pleural catheter|A soft silicone catheter (IPC) with a one-way valve at the end is inserted a few centimetres under the skin under local anaesthesia. The inside end of the catheter is inserted into the pleural space and the outside end is connected to a vacuum drainage bottle. The IPC permits regular fluid drainage.
15930925|NCT03412331|Device|Ultrasonic|Cavitron® BOBCAT® Pro, Dentsply International, USA
15930926|NCT03412331|Device|Hand Instruments|Gracey, SG 5/6, 7/8, 11/12, 13/14, Hu-Friedy Ins. Co., USA
15930927|NCT03412331|Device|LED Source|LED source (625-635 nm wavelength) (FotoSan®, CMS Dental, Denmark)
15930928|NCT03412318|Device|Twisted file|Use of twisted file during cleaning and shaping of root canals
15930929|NCT03412318|Device|Mpro|Use of Mpro during cleaning and shaping of root canals
15930930|NCT03412305|Drug|Amoxicillin|Antibiotic prophylaxis consisting of 4 amoxicillin tablets, totally 2 g, orally 1 hour before implant placement
15930931|NCT03412305|Other|Placebo|Placebo consisting of 4 tablets, orally 1 hour before implant placement
15930932|NCT03412292|Drug|MAX-40279|"MAX-40279, is a multi-targeted kinase inhibitor inhibitor mainly target FLT3 and FGFR. It has a molecular weight of 496.56 Daltons, which has a formula of C24H25FN6O3S.
~MAX-40279 is yellow powder. It is insoluble in water, methanol, ethanol, 0.1 mol/L hydrochloride solution or 0.1% saline; very slightly soluble in methylene dichloride and sparingly soluble in dimethylformamide. It is stable under strong acid, strong alkali, high temperatures and exposure to light.
~MAX-40279 for clinical use is presented as a sterile yellow powder packaged in capsules at 5 mg, or 25 mg doses."
15930933|NCT03412279|Behavioral|Application of the initial evaluation|Initial evaluation involves the application of Hausa ODI, NPRS, RMDQ, SF-12, PCS, GROC, BBQ, VAS for pain and disability, and FFD.
15930934|NCT03412279|Behavioral|Final application of instruments|Application of the Hausa versions of ODI, NPRS, RMDQ, SF-12, PCS, GROC and BBQ one week after initial evaluation
15930994|NCT03411772|Procedure|TAP block|Injection of 20 mL of 0.25% bupivacaine in the transversus abdominis plane under ultrasound guidance after performing bariatric surgery
15930995|NCT03411772|Procedure|Bariatric surgery|Bariatric surgery will be conducted
15930935|NCT03412266|Drug|Cytarabine|RIC preconditioning regimen consisted of cytarabine (2 g/m2/day, days -10 to -9), busulfan (3.2 mg/kg/day on days -8 to -6), cyclophosphamide (1.0 g/m2/day, days -5 to -4), fludarabine (30 mg/m-2/day, days -6 to -2), semustine (250 mg/m-2, day -3), and rabbit antithymocyte globulin (thymoglobulin, 2.5 mg/kg/d, days -5 to -2; Sanofi, France).
15930936|NCT03412253|Procedure|Single-Anastomosis Gastric Bypass surgery (SAGB).|We checked the effect of SAGB on patients suffered from T2DM with BMI 25-30
15930937|NCT03412240|Procedure|Induced pacing of the heart|Once the defibrillator leads have been inserted or, in the case of a box change, the old leads have been tested as per routine procedure, these pacing leads will be connected to an external pacing stimulator. The test involves electrically pacing your heart at different rates and we will be constantly monitoring you under close clinical supervision. During the test, your heart will be electrically stimulated to beat at a faster rate.
15930938|NCT03412227|Behavioral|Individual Behavioral Activation Therapy (IBAT)|IBAT is a manual-based, individual behavioral activation plus exposure therapy aimed at treating youth with anxiety, depression, and anger. The program consists of 10-14 weekly 60 minute sessions. It uses behavioral activation (BA) strategies to target avoidance by helping youth identify stuck points in their lives through functional assessment of numerous life domains, including family and peer interactions, school, extracurricular activities, and health and self-care.
15930939|NCT03412227|Behavioral|The PASCET Program for Youth Depressive Disorders|The Primary and Secondary Control Enhancement Therapy (PASCET; Weisz, Southam-Gerow, Gordis, & Connor-Smith, 2003; Weisz, Southam-Gerow et al., 2009; Weisz, Thurber, Sweeney, Proffitt, & LeGagnoux, 1997) is a brief (usually 11-15 sessions) CBT program for depressed youths typically aged 8-15. Sessions and practice assignments are built on findings concerning cognitive and behavioral features of, and beneficial treatments for, youth depression (e.g., Lewinsohn et al., 1990; Stark et al., 1987), and on the two-process model of perceived control and coping (Rothbaum, Weisz, & Snyder, 1982; Weisz et al., 1984a,b).
15930940|NCT03412227|Behavioral|The Coping Cat Program for Youth Anxiety Disorders|"The Coping Cat program (Kendall & Hedtke, 2006; Kendall, Choudhury, Hudson, & Webb, 2002) has received substantial empirical support for its efficacy in both children (9-13 years old) and teens (12 - 17 years old) (Kendall, 1994; Kendall et al., 1997; Kendall et al., 2008) and involves (1) teaching children to identify their own anxious feelings and physiological signs of anxiety, (2) teaching children to identify their own anxiety-provoking cognitions, (3) developing a plan to guide coping - a plan that involves changing the child's thoughts (into positive self-talk) and actions (into self-initiated exposures), and (4) self-evaluation and self-reward."
15930941|NCT03412227|Other|14-week waitlist (WL) condition|Youth assigned to the 14-week WL will receive no specific therapeutic services from study therapists during the 14-week WL period. However, participants will be assigned a WL Liaison whom families can contact in the event of clinical deterioration. The Liaison will also be responsible for sending links to, and monitor completion of, weekly and mid-WL online surveys (Qualtrics). Independent Evaluators will conduct post-WL diagnostic interviews at the completion of the 14-week WL. WL participants will receive compensation for completion of assessments. After completion of the WL, participants will be invited to continue in the study and be randomly assigned to one of the three behavioral treatments (IBAT, PASCET, or Coping Cat).
15930942|NCT03412214|Device|Perfusion index detected by pulse oximeter|Perfusion index detected by pulse oximeter
15930943|NCT03412214|Device|AAI|The AEP Monitor/2 (Danmeter A/S, Odense, Denmark), a commercialized system for depth of anesthesia monitoring, extracts the middle latency auditory evoked potentials (MLAEP) from the EEG-signal by using an autoregressive model with an exogenous input adaptive method.
15930944|NCT03412201|Other|Usual Care|Follow-up and management of heart failure medications provided by the patient's general physician and/or cardiologist according to local medical standards
15930945|NCT03412201|Other|High Intensity Care|Follow-up and management of heart failure medications provided by specialists at participating institutions. Doses of oral heart failure medications optimized within 2 weeks, provided clinical assessments and laboratory measures indicate that it is safe to increase doses.
15930948|NCT03412175|Behavioral|Behavioral Intervention|The CREATION Health Specialist (CHS) will review with the participant his/her biometrics, assessments, and surveys. The CHS will identify the participant's strengths and weaknesses thereby tailoring the intervention care plan to the participant. Together the participant and CHS will work on goal-setting, action plans, self-monitoring, identification of personal and social barriers to change, and self-regulatory techniques.
15930949|NCT03412162|Behavioral|Ethnic and Racial Identity Promotion|See arm description
15930950|NCT03412162|Behavioral|Academic Skills Promotion|See arm description
15930951|NCT03412149|Procedure|Mini Gastric Bypass|"Standardization of the techniques will be guaranteed:
~Mini Gastric Bypass Arm
~Roux en Y Gastric Bypass arm All patients will have intraoperative measurement of the whole length of bowel from Treitz ligament to the ileocecal junction (expected range 6-8 m).The common limb will be therefore about 2/3 of total small bowel length."
15930952|NCT03412149|Procedure|Roux en Y Gastric Bypass|"Standardization of the techniques will be guaranteed:
~Mini Gastric Bypass Arm
~Roux en Y Gastric Bypass arm All patients will have intraoperative measurement of the whole length of bowel from Treitz ligament to the ileocecal junction (expected range 6-8 m).The common limb will be therefore about 2/3 of total small bowel length."
15930953|NCT03412136|Dietary Supplement|Control|Participants were given 5 minutes to ingest the non-caloric beverage which contained 1.5ml of chocolate extract (Vanilla Food Company, Markham, Ontario, Canada) to account for the flavor differences and mixed with 500ml of water and sweetened with 0.2g sucralose (Tate & Lyle, Stoney Creek, Ontario, Canada) in order to match sweetness with the glucose beverage.
15930954|NCT03412136|Dietary Supplement|Glucose|Participants were given 5 minutes to ingest the beverage which contained either 1g of protein (plain whey-protein isolate; BiPro USA., Eden Prairie, Minnesota, U.S.A) per kg of bodyweight and was flavoured with 1.5ml of chocolate extract (Vanilla Food Company, Markham, Ontario, Canada) to account for the flavor differences and mixed with 500ml of water.
15930955|NCT03412136|Dietary Supplement|Protein|Participants were given 5 minutes to ingest the beverage which contained 1g of glucose monohydrate (BioShop Canada Inc., Burlington, Ontario, Canada) per kg of bodyweight and flavoured with 1.5ml of chocolate extract (Vanilla Food Company, Markham, Ontario, Canada) to account for the flavor differences and mixed with 500ml of water.
15930956|NCT03412123|Behavioral|group lifestyle-integrated functional exercise|Manualized teaching of balance and strength principles and integration of exercises and physical activity into daily routine during 7 sessions in a group of 8 to 10 participants with 2 trainers. The pilot intervention group will undergo the same strength and balance exercises and learn about the same physical activity enhancement strategies as described in the LiFE programme by Clemson et al. (BMJ 2012;345:e4547). However, instead of 7 home visits, gLiFE participants will attend seven group sessions (1 session/week). In these, LiFE contents are adapted to the group setting and enhanced by health psychological and behaviour change strategies fitting to the social structure and modalities of a group.
15930957|NCT03412110|Other|active surveillance: electronic platform|Provides a structure to systematically gather adverse event information from healthcare providers and sometimes directly from patients.
15930958|NCT03412097|Other|active surveillance|Provides a structure to systematically gather adverse event information from healthcare providers and sometimes directly from patients.
15930959|NCT03412084|Behavioral|Stand up and move more|4 week behavioral intervention involving the development and implementation of action plans
15930960|NCT03412071|Drug|Oral Tinidazole|Please see description under arms
15930961|NCT03412071|Drug|Topical metronidazole|Please see description under arms
15930962|NCT03412071|Drug|Topical Clindamycin|Please see description under arms
15930963|NCT03412071|Drug|Topical Hydrogen Peroxide|Please see description under arms
15930964|NCT03412058|Procedure|Biopsy|To be performed prior to anti-PD1/PD-L1 treatment initiation
15930965|NCT03412058|Procedure|Biopsy|To be performed after 42 (±3) days of anti-PD1 or PD-L1 treatment in consenting patients
15930966|NCT03412058|Procedure|Biopsy|To be performed at disease progression if medically feasible
15930967|NCT03412045|Device|hyperbaric oxygen therapy|hyperbaric oxygen therapy applied to patients in vaso-occlusive crisis
15930968|NCT03412032|Other|assessment|different assessments in both arms
15930969|NCT03412019|Other|Music|Selections of Mozart piano sonatas
15930970|NCT03412006|Drug|Fulacimstat (BAY1142524)|25 mg BAY1142524 are given twice daily over a treatment period of 6 months
15930971|NCT03412006|Drug|Placebo|Matching placebo tablets are given twice daily over a treatment period of 6 months
15930972|NCT03411993|Diagnostic Test|Focused cardiac echography|All pregnant women attending antenatal care will be eligible to undergo focused cardiac echo to identify underlying cardiac disease
15930973|NCT03411980|Drug|Vilaprisan (BAY1002670)|Single oral dose (1 x 2 mg immediate-release, film-coated tablet)
15930974|NCT03411967|Drug|Apatinib|apatinib mesylate tablets 500mg, po, qd, continued until the next cycle, taking on an empty stomach (daily taken at the same time), every 3 weeks For one cycle, a total of 4 to 6 cycles of treatment, apatinib has been taken until the disease progresses, intolerable toxicity.
15930975|NCT03411967|Drug|Docetaxel|Docetaxel, 60 mg / m2, d1, iv ,every 3 weeks For one cycle, a total of 4 to 6 cycles of treatment
15930976|NCT03411941|Drug|Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)|IVT(Intravitreal) aflibercept treatment in routine clinical practice.
15930977|NCT03411928|Device|Tracheolator|'Tracheolator' non-occlusive tracheal dilation balloon manufactured by Disa Life Sciences, Cape Town, South Africa.
15930978|NCT03411915|Biological|XmAb18087|monoclonal bispecific antibody
15930979|NCT03411902|Drug|Risedronate Sodium 150 MG|Subjects randomized to the Risedronate group will take a 150 mg capsule of oral Risedronate once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.
15930980|NCT03411902|Other|Placebo|Participants randomized to the placebo group will receive 150 mg placebo capsule once every 4 weeks for 24 weeks (6 doses), beginning 1 week prior to surgery and dispensed in blinded capsules from the WFSM research pharmacy.
15930981|NCT03411889|Diagnostic Test|MRI scanning|MRI scanning during tear drainage
15930982|NCT03411876|Device|Oxymizer® pendant nasal cannula|Supplemental oxygen is provided by an Oxymizer pendant nasal cannula.
15930983|NCT03411876|Device|conventional nasal cannula|Supplemental oxygen is provided by a conventional nasal cannula.
15930984|NCT03411863|Device|CES at rest|"CES will be delivered at rest at various intensities, in combination with either electrical stimulation over peripheral nerves or magnetic stimulation over the motor cortex.
~This is an experiment designed to measure CES interactions with other central and peripheral nerve circuits."
15930985|NCT03411863|Device|CES plus active hand or wrist movements|"CES will be delivered while the participant performs specific finger or wrist tasks at different degrees of effort.
~This is an experiment designed to detect momentary changes in muscle function."
15930986|NCT03411850|Biological|Orencia|FDA approved biologic
15930987|NCT03411850|Other|Placebo|
15930988|NCT03411837|Biological|Dupilumab|Biologic (monoclonal antibody)
15930989|NCT03411824|Other|no intervention|Non applicable
15930990|NCT03411811|Other|Usual Care|Therapeutic ultrasound, myofascial release of extensor and flexor muscles of forearm and stabilization exercises for the wrist.
15930991|NCT03411811|Procedure|Dextrose|Injection of 1 ml of 12.5% dextrose in 1% lidocaine at 0, 3 and 6 weeks in 5 locations: Origin of ulnar collateral ligament, insertion of ulnar collateral ligament on the triquetrum, insertion of the extensor carpi ulnaris on the base of the 5th metacarpal, triquetral hamate ligament and ulnotriquetral joint space.
15930992|NCT03411798|Drug|Yisaipu®|Yisaipu® was introduced only during the active state and was switched to DMARDs, methotrexate(MTX), sulfasalazine(SSZ) and hydroxychloroquine(HCQ), after disease remission (ESR & CRP reduce to normal and BASDAI<4) maintenance.
15930993|NCT03411785|Other|CPC+ model|CPC+ practices receive a monthly care management fee and prospective performance-based incentive payment on top of traditional payments. Some practices will also receive some payment that shifts away from fee-for-service. In addition, CPC+ practices will receive learning and health IT support and data feedback to implement processes to meet care delivery requirements and achieve five primary care functions.
15931093|NCT03410862|Drug|Elderberry Extract|Thick reddish-brown liquid of Sambucus Nigra (Black Elderberry)
15930996|NCT03411746|Other|Subarachnoid haemorrhage|Data on the type of patients enrolled have been described already in other sections.
15930997|NCT03411733|Other|Blood and stool samples collection|Collection of blood and stool samples from each participants for H.pylori antigen/ antibody detection
15930998|NCT03411720|Other|FES Row Training|Hybrid FES Row Training using voluntary upper body and electrically-stimulated lower body
15930999|NCT03411707|Diagnostic Test|Stool DNA test|Stool DNA test could detect specific gene methylation in stool DNA. Blood mRNA test could detect specific set of gene expression in blood.
15931000|NCT03411694|Other|Survey|Survey in patients from the Jessa Hospital that are planned for elective surgery, both ambulatory and inpatient.
15931001|NCT03411681|Other|Resistance Exercise|Participants will perform 4 sets of 12 repetitions of moderate intensity leg extension
15931002|NCT03411668|Other|EBP Educational Programme|The educational EBP programme will include 12 hours of classroom lessons regarding EBP more 6 hours of mentorship made to a small groups of students (2 or 3 students per group).
15931003|NCT03411655|Device|Ambu Aura GainTM|Time and success rate
15931004|NCT03411655|Device|Ambu® Aura-ITM|Time and success rate
15931005|NCT03411603|Other|Diet and socio-demographic questionnaires|24-hr recall or food diary questionnaires; socio-demographic questionnaires
15931006|NCT03411590|Other|Fortified milk Powder|Toddlers will be allocated to the 200 ml group and will receive on a daily basis 32g of growing up milk powder respectively, in doses of 16 g, which can be reconstituted with 180 ml water to a final volume of about 200 ml of milk. The intervention period will last for 6 months. For the 200 ml test group, this translates into 32 g of growing up milk powder supply as one dose per day (in the morning)
15931007|NCT03411577|Other|Behavioral Intervention|
15931008|NCT03411564|Other|Filming Together to See Ourselves in a New 'Present'|"PHASE 0. PRIOR TRAINING 1) Promoting protective assets related to violence together. 10-hour training session with 10-15 secondary school teachers; 2) Identifying our own protective assets against violence. This training activity will be addressed to targeted students. The activity will be carried out in four sessions of 1 hour in duration.
~PHASE 1.PRE-PRODUCTION. 1) Participant activity on building story arguments; and 2) Construction of a technical and literary guide to the video capsules.
~PHASE 2: PRODUCTION.- 1) Rehearsal of the script developed by each group; 2) Preparation and selection of environment, wardrobe and characterization of the roles and, 3) Filming of the video capsules.
~PHASE 3: POST-PRODUCTION.- This phase consists of putting together the short film using the various video capsules.
~PHASE 4: DISSEMINATION. A short film exhibition to provide a space where participants can present their video capsules and briefly explain the production process."
15931009|NCT03411551|Procedure|regional anesthesia|The analgesic effectivity of the forearm intravenous regional anesthesia and the ultrasound-guided peripheral nerve block will be investigated in patients undergoing carpal tunnel release
15931010|NCT03411538|Other|Collect data on clinical history|Collect data on clinical history, clinical manifestation, comorbidity, admission data, use of invasive medical intervention, history of antibiotic treatment and antibiotic susceptibility test results
15931011|NCT03411525|Behavioral|Commitment Invitation for Clinicians (Clinician Intervention)|Clinicians will be invited to commit to follow 3 Choosing Wisely® recommendations. Those that choose to commit will sign a written document, appear on in-clinic posters along with their colleagues who have committed to the recommendations, have access to point-of-care Choosing Wisely® patient education handouts, and receive weekly emails with decision support resources.
15931012|NCT03411525|Other|Health Education Materials to Patients (Patient Intervention)|During the intervention period, the letter and study information sheet that eligible patients will receive in advance of a scheduled appointment with a participating clinician will also be accompanied by a patient education handout from Consumer Reports that is publicly available and may be relevant to their health and health care. Specifically, patients with type 2 diabetes who are 65 and older will receive a handout about diabetes overtreatment, patients with insomnia or anxiety who are 65 and older will receive a handout about overuse of benzodiazepines and sedative-hypnotics, and male patients who are 75 and older with no history of prostate cancer will receive a handout about overuse of PSA tests to screen for prostate cancer.
15931013|NCT03411499|Procedure|Early surgery|Surgery within 72 hours from endocarditis diagnosis
15931014|NCT03411499|Procedure|Conventional therapy|Delayed surgical intervention or medical treatment according to the current guidelines
15931015|NCT03411473|Biological|AGEN1884 in combination with pembrolizumab|AGEN1884 in combination with pembrolizumab in subjects with stage IV NSCLC whose tumors have high PD-L1 expression and no EGFR or ALK genomic tumor aberrations
15931016|NCT03411460|Device|FreeStyle Libre™ system|Measured non-invasively via scanner
15931017|NCT03411460|Procedure|Finger prick|Blood test
15931018|NCT03411447|Other|Parenteral nutrition|
15931019|NCT03411447|Other|Enteral nutrition|
15931020|NCT03411434|Drug|Methylphenidate Oral Tablet|cf arm group description
15931021|NCT03411421|Drug|AL-794|AL-794 will be administered as tablets orally on Day 1 to Day 5.
15931022|NCT03411421|Drug|Placebo|Matching placebo tablets will be administered.
15931023|NCT03411408|Device|HBO|"Hyperbaric oxygen is administrated in a multiplace hyperbaric chamber according to the following schedule:
~Ten minutes of compression with a Fraction of inspired oxygen (FiO2) more than 90% from 152 to 253 kilopascal, 60 minutes of Fraction of inspired oxygen (FiO2) more than 90% at 253 kilopascal (three breathing cycles in oxygen for 22 minutes each, with two intervals breathing air for 2 minutes each) and 10 minutes of decompression with a Fraction of inspired oxygen (FiO2) more than 90% from 253 to 152 kilopascal."
15931024|NCT03411408|Radiation|RT|tomotherapy (within 60 minutes from completion of decompression of hyperbaric chamber) with 3-5 consecutive sessions- one fraction per day, 5 Gy / die .
15931025|NCT03411395|Dietary Supplement|5AA+CrPic Water|Dietary supplement drink with carbonation, aroma, amino acids and chromium picolinate
15931026|NCT03411395|Other|Placebo drink|Placebo water with carbonation and aroma
15931027|NCT03411382|Other|Sit muscle strength training|Sit muscle strength training using a sand bag grip ball conducted twice a week. Each exercise session will begin and end with a 5-15 minute warm-up and cool-down routine. The exercise program consists of 20-40 minute chair-based resistance exercises.
15931028|NCT03411382|Other|Game training|Game training (including ball activities, clay courses, massage, puzzles, painting conducted four times a week). Each section 30-60 minutes.
15931029|NCT03411382|Other|Sitting strength + game training|Sitting strength training (using sandbag training conducted twice a week) and game training (such as ball activities and clay courses) conducted twice a week).
15931030|NCT03411382|Other|Health education|Health education (conducted once a month). Each section 50-60 minutes. The topics are oral hygiene, medicine safe, living safe, food safe.
15931031|NCT03411369|Dietary Supplement|Creatine, D-Ribose, B1 Vitamin, and B6 vitamin|The treatment will consist of taking 2 sachets / day for the first two weeks, and then continuing with 1 sachet/day for the next month.
15931032|NCT03411369|Other|Placebo|Water-soluble powder in sachets of 4 grams containing inert product consisting of starch powder.
15931033|NCT03411356|Behavioral|Daily Caloric Restriction (DCR)|Participants in this group will be given a calorie goal designed to produce a 34.3% energy deficit from estimated baseline weight maintenance energy requirements. Participants in this group will also receive a 12 month comprehensive group-based behavioral weight loss program and will be instructed in specific strategies to support DCR. Randomized groups will meet separately. Participants in this group will also be asked to increase moderate intensity physical activity to a target of 300 minutes per week.
15931034|NCT03411356|Behavioral|Intermittent Fasting (IMF)|Participants in this group will be instructed to limit energy intake to 20% of estimated baseline energy requirements on three non-consecutive days per week, and to eat ad libitum the other 4 days per week. Participants in this group will also receive a 12 month comprehensive group based behavioral weight loss program and will be instructed in specific strategies to support IMF. Randomized groups will meet separately. Participants in this group will also be asked to increase moderate intensity physical activity to a target of 300 minutes per week.
15931035|NCT03411343|Procedure|Interscalene Block|Injection with ultrasound guidance of 20mL of levobupivacaine 0.5% with 5 micrograms of epinephrine per mL in the interscalene groove of the brachial plexus.
15931036|NCT03411343|Procedure|Costoclavicular Infraclavicular Block|Ultrasound guided brachial plexus block injecting 20mL of 0.5% levobupivacaine with 5 micrograms of epinephrine per mL in between the cords of the brachial plexus at the costoclavicular infraclavicular space.
15931037|NCT03411330|Drug|Hyaluronidase|Scalp nerves block will be done using lidocaine (2%) in a maximum dose of 300 mg and bupivacaine (0.5%) with maximum allowed dose 175 mg in group A, Hyaluronidase will be added in group H in a dose of 1500 IU (The minimum and maximum effective doses of hyaluronidase are not known. The doses used range from0.75 IU/ml to 300 IU/ml
15931038|NCT03411330|Drug|Lidocaine|lidocaine (2%) in a maximum dose of 300 mg and bupivacaine (0.5%)
15931039|NCT03411330|Drug|Bupivacaine|bupivacaine (0.5%)
15931040|NCT03411291|Device|MRI, MR Spectroscopy, MR Perfusion|One brain MRI/MR Spectroscopy/MR Perfusion at baseline and one brain MR/MR Spectroscopy/MR Perfusion at 3 months.
15931041|NCT03411278|Device|Deep Oscillation (DO)|"DO self treatment with the device mobile (Physiomed, Laipersdorf, Germany; U.S. patent 7,343,203 B2).The device produces an alternating electrostatic field, which results in a low-frequency vibration penetrating the tissue. The Field is pulsed at a frequency of 90 Hz. For self-treatment, each volunteer is given an apparatus to take home. An applicator with a diameter of 9 cm is used. The treatment will be carried out in the morning and evening for 15 minutes each in supine position on a sofa. In accordance with the technique of classical manual lymphatic drainage, stroking and circular movements in the upper and lower leg and the inguinal area take place in a fixed order."
15931042|NCT03411265|Other|self-administered, e-health application|"RETAIN is a self-administered, e-health application and includes short videos in which patients who are successfully engaged in MAT discuss what they wish they had known about MAT and its benefits when they started treatment. The intervention is designed to maximize scalability - the administration would entail handing an electronic device (e.g., tablet, laptop, etc.) to an individual who would then self-administer the intervention."
15931043|NCT03411252|Drug|Mirabegron 50 MG|Myrbetriq (Mirabegron) tablet
15931044|NCT03411252|Drug|Placebo|Sugar pill manufactured to mimic Mirabegron
15931045|NCT03411239|Device|Adult esophageal balloon catheter (obc)|Using OBC to determine airway pressure changes in patients undergoing general anaesthesia for laparoscopic surgery
15931046|NCT03411226|Procedure|re-TREPP|repeated hernia repair via the TREPP technique
15931047|NCT03411213|Device|diffuse optical tomography|Optical tomography is a form of computed tomography that creates a digital volumetric model of an object by reconstructing images made from light transmitted and scattered through an object.
15931048|NCT03411200|Behavioral|Multimodal and exercise-based intervention|"The multimodal and exercise-based intervention is comprised of:
~Supervised and group-based exercise two times a week (60 minutes per session). The program consists of warm-up, exercises for balance and flexibility, progressive resistance training, and stretching and relaxation.
~Individualized activity program based on step counts (with activity tracker). Based on each participant's starting point, preferences and motivation, an individualized program will be composed. Evaluation and goal-setting will be conducted once weekly.
~Nurse-led supportive and motivational counseling; each participant will be invited to two sessions of counseling (in week 1 + 6). Each session will be based on a holistic assessment of each participant's life situation. Advice and counseling will be provided based on identified problems and needs.
~A nutritional supplement (protein bar or drink) will be served to participants immediately after the supervised exercise session."
15931049|NCT03411187|Device|used of the Pressure adjustable foot-control method|Whether The Pressure adjustable foot-control method is used.
15931050|NCT03411187|Device|direct exhaust|direct exhaust through the trocar.
15931051|NCT03411174|Radiation|hypofractionated partial breast irradiation|deliver 40Gy/15Fx to tumor bed areas
15931052|NCT03411161|Drug|Combination therapy (S81694 + paclitaxel) phase I|Dose escalation S 81694 (IV); paclitaxel started at 80 mg/m²,(IV)
15931053|NCT03411161|Drug|Paclitaxel|Paclitaxel (IV) at 80 mg/m²/week
15931054|NCT03411161|Drug|Combination therapy (S81694 + paclitaxel) phase II|S 81694 (IV) at RP2D; paclitaxel (IV) at 80 mg/m²/week
15931055|NCT03411148|Behavioral|Weekly exercise sessions with physical therapist and psychologist|Eight weekly sessions integrating techniques from physical therapy and cognitive behavioral therapy. At the start of each session participants play virtual reality games that target balance and functional gait and then discuss their balance confidence and activity avoidance behaviors with a behavioural counselor. Weekly homework assignments ask participants to report on thoughts causing them to avoid activities and to slowly engage in activities that present increasing levels of fear.
15931056|NCT03411148|Behavioral|Home-based exercises|Stretching and other exercises are safely taught by physical therapist and then practiced at home following a provided schedule. Participants receive periodic calls to discuss progress.
15931057|NCT03411135|Other|VES and VASI scores as assessment methods for vitiligo|compare VES and VASI scores as assessment methods for vitiligo
15931058|NCT03411122|Drug|napabucasin|Napabucasin will be administered at dose of 240 mg twice daily, every 12 hours (BID) on days 1-2 in period 1, and on days 1-11 in period 3.
15931059|NCT03411122|Drug|cytochrome P450 (CYP450) probe drugs or BCRP transporter substrate|CYP450 probe drugs or BCRP transporter substrate will be administered once every period during days 1-4 in period 2, and days 6-9 in period 3.
15931060|NCT03411109|Drug|Hydromorphone Hydrochloride|All intrathecal injections were performed preoperatively using a 22g or 25 g Whitacre or 24g Sprotte spinal needle. The IA regimen, medication(s) and dose(s), was at the discretion of the attending anesthesiologist, and consisted of one of the following regimens: (1) hydromorphone + local anesthetic (IA-L), or (2) hydromorphone only (IA-O). In patients receiving IA, no other interventional locoregional analgesic techniques (such as rectus sheath blocks or transversus abdominis plane blocks) were utilized.
15931061|NCT03411096|Procedure|Quadratus lumborum block using ropivacaine|After general anesthesia, an anesthesiologist will perform an quadratus lumborum block with 0.75% ropivacaine (20cc) under ultrasound guidance.
15931062|NCT03411096|Procedure|Quadratus lumborum block with normal saline|After general anesthesia, an anesthesiologist will perform an quadratus lumborum block with normal saline (20cc) under ultrasound guidance.
15931063|NCT03411083|Procedure|Total or unicompartmental knee replacement|Fast-track Knee replacement surgery including same day surgery
15931064|NCT03411070|Device|Implanted Medical Device|Undergo SCOUT reflector placement
15931065|NCT03411070|Procedure|Therapeutic Conventional Surgery|Undergo surgery
15931066|NCT03411057|Behavioral|Mindfulness Based Stress Reduction (MBSR)|An interactive form of meditation that includes gentle yoga.
15931067|NCT03411057|Other|Control|Standard of care including an educational video.
15931068|NCT03411044|Device|Fitmore Hip Stem|
15931069|NCT03411031|Drug|Elotuzumab|Elotuzumab according to dosing schedule outlined in treatment arms.
15931070|NCT03411031|Drug|Lenalidomide|Lenalidomide according to dosing schedule outlined in treatment arms.
15931071|NCT03411031|Drug|Dexamethasone|"Dexamethasone is a commercially available drug. The description, how supplied, and storage instructions for dexamethasone product are found in the prescribing information.
~During the study, dexamethasone will be administered as premedication for elotuzumab as indicated in the package insert."
15931072|NCT03411018|Other|Mechanical ventilation exposure|
15931073|NCT03411005|Dietary Supplement|Metabolic availability of lysine in sorghum|Four levels of lysine intakes will be provided by the reference protein drinks, 3 levels of lysine from sorghum and 1 level from sorghum with lentils.
15931074|NCT03410992|Drug|Bimekizumab|Bimekizumab will be provided at pre-specified time intervals.
15931075|NCT03410992|Other|Placebo|Subjects will receive Placebo at pre-specified time points to maintain the blinding of the Investigational Medicinal Products.
15931076|NCT03410979|Drug|GLPG2737 single dose|GLPG2737 oral suspension, single ascending doses
15931077|NCT03410979|Drug|Placebo single dose|Placebo, oral suspension.
15931078|NCT03410979|Drug|GLPG2737 multiple dose|GLPG2737 oral suspension, multiple ascending doses, daily for 14 days.
15931079|NCT03410979|Drug|GLPG2737 multiple dose|Placebo, oral suspension, daily for 14 days
15931080|NCT03410966|Procedure|trans cateheter ablation|All AF patients will receive trans catheter ablation by radiofrequency, to destroy arrhythmic atrial cells, and to isolate arrhythmic atrial firing around pulmonary veins' ostia.
15931081|NCT03410953|Biological|Fendrix suspension for injection Hepatitis B (rDNA) vaccine (adjuvanted, adsorbed).|"The primary immunisation consists of 4 separate 0.5 ml doses administered at the following schedule:
~1 month, 2 months and 6 months from the date of the first dose. Once initiated, the primary course of vaccination at 0, 1, 2 and 6 months should be completed with Fendrix, and not with other commercially available HBV vaccine"
15931082|NCT03410940|Device|CLS Brevius stem with Kinectiv technology|
15931083|NCT03410927|Drug|TAS0728|TAS0728 is an oral HER2 covalent inhibitor investigated in patients with advanced solid tumor harboring HER2 or HER3 abnormalities. It will be administered orally at a starting dose of 50 mg BID each morning and evening and escalated to the DLT. The MTD will be used for the phase 2 arms of the study.
15931084|NCT03410914|Device|Hemopatch|Application of hemopatch to the divided end of the pancreas during surgery.
15931085|NCT03410901|Biological|Anti-OX40 Antibody BMS 986178|Given IV, intratumoral
15931086|NCT03410901|Other|Laboratory Biomarker Analysis|Correlative studies
15931087|NCT03410901|Radiation|Radiation Therapy|Undergo radiation therapy
15931088|NCT03410901|Drug|TLR9 Agonist SD-101|Given intratumorally
15931089|NCT03410888|Procedure|Popliteal approach|"Popliteal approach:
~Under ultrasound guidance a 50 to 90 mm 22 G needle is inserted in and advanced to contact the target nerve until nerve movement is detected. The end point of nerve block in this group is obtaining a circumferential local anesthetic spread around the sciatic nerve."
15931090|NCT03410888|Procedure|Infragluteal approach|Infragluteal approach: The patients in this group will receive sciatic bock according to the approach described by Chan et al. Ultrasound scanning will be used to identify and mark the greater trochanter laterally and the ischial tuberosity medially. The sciatic nerve is usually found anterior (deep) to the gluteus maximus muscle and lateral to the origin of the biceps femoris muscle at the ischial tuberosity as well as medial to the greater trochanter. The end point of nerve block in this group is obtaining a circumferential local anesthetic spread around the sciatic nerve.
15931091|NCT03410875|Drug|Vemurafenib|Eligible patients will receive vemurafenib at a dose of 960mg orally twice daily (b.i.d.) continuously in cycles of 4 weeks (28 days) for a total of 4 cycles. In case of certain defined toxicities, dose reductions of vemurafenib by 50% (480mg b.i.d.) or interruptions of up to 15 days are permitted. If additional dose reduction is required, vemurafenib may be reduced to 240mg oral b.i.d.
15931092|NCT03410875|Drug|Obinutuzumab|Obinutuzumab will be administered concomitantly with vemurafenib starting at cycle 2 of treatment in cycles of 4 weeks. Obinutuzumab infusions will be administered at 1000mg per day on days 1, 8 and 15 during the cycle 2 and 1000mg per day every 4 weeks during the cycle 3 and 4 of treatment.
15931094|NCT03410862|Drug|Placebos|Thick reddish-brown liquid similar in appearance and taste to Elderberry Extract not containing elderberry
15931095|NCT03410849|Diagnostic Test|Gastroscopy|in both arms intervention 'gastroscopy' will be carried out
15931096|NCT03410836|Drug|intravenous lidocaine (IVL)|lidocaine 2% will be used for induction (1 syringe of 5 ml, administered dose of 1.5 mg / kg) and for intra-operative infusion (1 syringe of 30 ml, infusion dose of 1.5 mg / kg / h). Lidocaine syringes and placebo will be prepared on a blinded manner so that the investigating anesthesiologist in charge of the patient in the operating room, as well as the respiratory therapist and the recovery room nurse and the floors do not know what the patient received during the anesthesia (whether IVL or placebo).
15931097|NCT03410836|Other|Placebo|Group Control will receive (double blinded) an infusion of saline at the same volume and regimen than the lidocaine 2% group (IVL).
15931098|NCT03410823|Behavioral|PUSH|Strength components of the muscle performance intervention are performed using a portable progressive resistive exercise device (Shuttle® MiniPress, Contemporary Design Company, P.O. Box 5089, Glacier, Washington 98244). Muscle performance focuses on bilateral hip extensors, hip abductors, knee extensors, and plantar flexors. Balance and strength are addressed with additional exercises performed while standing. The endurance intervention begins with 2-3 minutes of continuous upper and lower extremity active range of motion (AROM) with the participant sitting in order to increase the participants' heart rate (HR) or exertion closer to the target zone. The participant is then asked to walk on level surfaces and/or up and down steps to keep the HR within the training zone for 20 minutes.
15931099|NCT03410823|Dietary Supplement|Protein|Participants will receive a whey-based protein supplement in the form of a powder containing 27.6g of protein. This dose induces maximum muscle protein synthesis post-exercise. Participants will mix the supplement in 8 oz of water (or other beverage) or soft food (e.g., yogurt, soup) and consume immediately following each exercise session with the study PT. On days when they do not have a physical therapy visit with the study PT, participants will be instructed to take the supplement at the meal time closest to the time of scheduled PT visits to maintain regular daily dosing schedule.
15931100|NCT03410823|Dietary Supplement|Nutrition|Participants receive 2000 IU vitamin D3, 600 mg calcium, and a multivitamin daily for the duration of the study. Nutritional counseling is also provided. Participants are screened at baseline to assess nutritional risk using the Mini Nutritional Assessment-Short Form and contacted by a registered dietician (RD) within 7 days of baseline testing Those who score ≤7 (malnourished) and participants with baseline serum albumin 2.5-3.5 g/dl receive a visit from an RD with follow-up a week later. Participants who score 8-11 (at risk of malnutrition) and have serum albumin level >3.5 g/dl receive a phone call from the RD and may receive an in-person visit if warranted. Those screening in the normal range (12-14) and have serum albumin level >3.5 g/dl receive a phone call from the RD. Weight is monitored every 4 weeks. Those who lose 2% or more body weight receive a call from the RD. Those who lose 5% or more body weight between baseline and follow-up may be referred to an RD.
15931101|NCT03410810|Diagnostic Test|MRI|MRI analysis
15931102|NCT03410810|Diagnostic Test|Neurodevelopmental/Neuropsychological Assessment|Standardized Cognitive and Developmental Tests
15931103|NCT03410797|Device|Inclusion of semi-occluded mask in voice therapy|Patients will be given a facemask with a semi-occlusion (SOMask) for use during in person voice therapy and for use at home therapy practice.
15931104|NCT03410784|Drug|Pembrolizumab|Pembrolizumab 200 mg i.v. on Day 1 every 3 weeks up to 22 cycles
15931105|NCT03410784|Drug|Paclitaxel|Paclitaxel 175 mg/m2 i.v. on Day 1 every 3 weeks up to 6 cycles
15931106|NCT03410784|Drug|Carboplatin|Carboplatin (AUC 5) i.v. on Day 1 every 3 weeks for up to 6 cycles
15931107|NCT03410771|Drug|Monitor antibiotic exposure (PK profile)|several plasma samples to measure drug exposure
15931108|NCT03410771|Device|Bioelectrical impedance analysis to measure body composition|non invasive analysis (electrodes) to measure extra- and intracellular, and total body water.
15931109|NCT03410745|Behavioral|Exercise.|Moderate to heavy intensity resistance exercise consisting of leg press.
15931110|NCT03410732|Biological|activated DCs|autologous dendritic cells are collected and enriched from 50 ml of peripheral blood, then activated by autologous tumor cell membrane proteins. Then the activated DCs are iv infused in 21 days after a radical surgery.
15931111|NCT03410732|Procedure|radical surgery only|Only radical surgery is given to the control group
15931112|NCT03410719|Other|Hi GI|subjects will consume the same quantities of metabolizable CHOs (270 g/d) with 135 g of CHOs assigned to the GI intervention foods. The 135 g of CHOs will be distributed as 35 g GI breakfast product, 40 g GI lunch product, and 60 g GI dinner product. Assuming an average 2400 kcal/d total energy requirement among subjects, the 270 g/d metabolizable CHO equates to 40% of total energy intake (1080 kcal/d). One-half of daily CHO intake (135 g/d) will be the same between the Hi-GI and Low-GI groups, including CHOs in fruits, vegetables, and other foods that all subjects will consume. The other one-half of daily CHO intake (135 g) will be different between the Low-GI and Hi-GI groups. Specifically, the GI values of these foods will either be <55 (Low-GI group) or >70 (Hi-GI group).
15931113|NCT03410706|Drug|Rivaroxaban(Xarelto, BAY 59-7939)|The dosage and the anticoagulation duration is decided by investigators. As list in product information, the PE treatment dosage of rivaroxaban is 15mg bid for first 21 days and then 20mg qd. If CrCl is 30-49 ml/min and bleeding risk is over VTE recurrence risk, 20mg qd can be replaced with 15mg qd.
15931114|NCT03410693|Drug|Rogaratinib (BAY1163877)|Rogaratinib administered as oral (p.o.) tablets twice daily (b.i.d.) continuously
15931115|NCT03410693|Drug|Chemotherapy|Chemotherapy as taxane (docetaxel or paclitaxel) or vinflunine administered through intravenous (i.v.) infusion every 3 weeks (on day 1 of a 21-day cycle) The choice of the chemotherapy is at the discretion of the investigator, taking into consideration the status of the authorization or treatment guidelines in the given country.
15931116|NCT03410680|Behavioral|FUERTES|The intervention focuses on antiretroviral therapy habit-formation among MSM living with HIV
15931117|NCT03410667|Behavioral|Phase One: Exploration|"Spina Bifida patients from the pediatric urology clinic at Riley Hospital and their caregivers will participate in discussions of UI goals. These patients will self report their experiences and perspectives using a Day in the Life diary tool-kit."
15931118|NCT03410667|Behavioral|Phase Two: Creation|Patients, caregivers and providers will work to create a goal setting tool to help patients and physicians appropriately address the issue of UI in patients with spina bifida.
15965363|NCT03147638|Drug|Warfarin, NOAC|duration of treatment
15931119|NCT03410667|Behavioral|Phase Three: Reflection|This is a validation step to test whether the goal-setting tool is widely applicable and functional in a clinic setting. There will be cognitive interviews after the tool is completed to gather patient impressions.
15931120|NCT03410667|Behavioral|Aim 2|This will be a large scale validation of the tool.
15931121|NCT03410654|Drug|Tacrolimus, Extended Release, (Envarsus Xr)|After conversion of tacrolimus immediate release to tacrolimus extended release.
15931122|NCT03410641|Behavioral|Diet and antismoking advice|Dietary advice with the aim of reducing participant's serum cholesterol levels, including reduction in the intake of saturated fat and cholesterol, and increased intake of polyunsaturated fat, fish, vegetables and fruit. Weight reduction was recommended for overweight men, as well as reduced consumption of sugar rich foods and drinks, and alcoholic beverages. Smokers were advised to stop smoking. The advice was given both individually and in group sessions during a five-year time period from 1972/3 until 1977/8.
15931123|NCT03410628|Device|gammaCore|Non-invasive vagal nerve stimulator
15931124|NCT03410615|Radiation|Radiation|70 Gy in 35 fractions over 7 weeks (i.e. 2 Gy per fraction)
15931125|NCT03410615|Drug|Cisplatin|100 mg/m2 days 1, 22, 43 concurrently with RT
15931126|NCT03410615|Drug|Durvalumab|Given in concurrent and adjuvant phase
15931127|NCT03410615|Drug|Tremelimumab|ARM CLOSED TO ACCRUAL - 2019
15931128|NCT03410602|Procedure|Full-mouth supragingival scaling|Control group comprised of 15 patients who were treated with routine full-mouth supragingival scaling.
15931129|NCT03410602|Procedure|Subgingival scaling|Test group comprised of 15 patients who were treated with subgingival scaling only around all banded first molars.
15931130|NCT03410602|Drug|Subgingival irrigation|Test group comprised of 15 patients who were treated with subgingival irrigation only around all banded first molars with 0.2% chlorhexidine gluconate solution (Trade name: HEXIDINE), an antiseptic - antiplaque agent.
15931131|NCT03410589|Other|Sinlge arm|application of scales for evaluation of sleep, fatigue and quality of life - Observational study
15931132|NCT03410576|Procedure|Carotid artery stenting|Patient undergo elective carotid artery stenting. In this patient group blood sampling was performed at three time points: T1, at the time of the insertion of the arterial line; T2, 60 min after stent insertion; and T3: the first postoperative morning.
15931133|NCT03410576|Procedure|Carotid endarterectomy|Patient undergo elective carotid endarterectomy. Group samples were collected at the following four time points: T1, at the time of the insertion of the arterial line; T2, 60 min after cross-clamp release; T3, the first postoperative morning; and T4, the third postoperative morning. A matched subgroup of patients from the previously obtained data served as a historical control.
15931134|NCT03410563|Behavioral|Auditory inputs|Three different auditory inputs
15931135|NCT03410550|Device|Exoskeleton Training|Twenty subjects will participate in a powered exoskeleton (EKSO) for one or twice a week for 12 weeks. The program will involve walking with the robotic suits for 1 hour for persons with complete (n=10) and persons with incomplete (n=10).
15931136|NCT03410537|Drug|Taurine|
15931137|NCT03410537|Drug|Placebo|
15931138|NCT03410524|Drug|Simethicone Solution|200 mg of Simethicone in 3 mL of Simethicone Solution Formulation
15931139|NCT03410524|Drug|Water|3 mL of water as placebo added to the bowel preparation
15931140|NCT03410511|Other|Nicotine free intake|The participant will wean off nicotine during five days before the experimental session. At the start of the experimental session, participants will be exposed to acute propylene glycol/glycerol (mix 50:50) intake.
15931141|NCT03410511|Other|Nicotine intake|The participant will pursuit his regular nicotinic propylene/glycerol intake five days before the experimental session. At the start of the experimental session, participants will be exposed to acute propylene glycol/glycerol (mix 50:50) intake.
15931142|NCT03410511|Other|Cessation intake|The participant will completely stop his regular nicotinic propylene/glycerol intake during five days before the session. At the start of the experimental session, participants will mimick intake with the device turns off.
15931143|NCT03410498|Other|Incremental shuttle walk test|"In the incremental shuttle walk test, participants will have to walk between two cones (10m distance) several times. The time they will have to cover the distance between the two cones (signified by 'bleeps') will become increasingly shorter, until they cannot get to the next cone before the next 'bleep'. This test will last a maximum of 20 minutes.
~In the Stroop test, the words of four colours, but written with a different colour, will be projected on the wall in front of participants and they will need to identify the colour of the text and ignore the word itself."
15931144|NCT03410485|Device|BIS index/NoL index|"Remifentanil i.v. infusion will be run between 0.03 and 0.15 mcg/kg/min and boluses (0.4mcg/kg) will be given to keep a NoL index between 10-20.
~Once intubated, the maintenance of anesthesia will be achieved with: desflurane set at 1 MAC to start, then adapted to the BIS between 45-55."
15931145|NCT03410485|Device|Variation of baseline mean arterial pressure|"Remifentanil i.v. infusion will be run between 0.03 and 0.15 mcg/kg/min and boluses (0.4mcg/kg) will be given to keep a baseline mean arterial pressure between 10% of variation.
~Once intubated, the maintenance of anesthesia will be achieved with: desflurane set at 1 MAC to start, then ajusted to 0.8 MAC."
15931146|NCT03410472|Behavioral|Web based diet application|This group will be asked to record their diets for 8 weeks after being told an approximate calorie goal. This group will receive weekly emails with tips on how to eat healthy
15931147|NCT03410459|Diagnostic Test|DEXA (= Dual-energy x-ray absorptiometry)|measurement of vertebral bone and hip bone mineral density
15931148|NCT03410446|Drug|Ketamine Hydrochloride|Ketamine is a N-methyl-D-aspartate (NMDA) antagonist.
15931149|NCT03410433|Device|Silk 4.0|Silk suture 4.0
15931150|NCT03410433|Device|PG 910 4.0|PG 910 4.0
15931151|NCT03410433|Device|PP 4.0|PP 4.0
15931152|NCT03410433|Device|Silk 5.0|Silk 5.0
15931153|NCT03410433|Device|PG910 5.0|PG910 5.0
15931154|NCT03410433|Device|PP 5.0|PP 5.0
15931155|NCT03410433|Device|APG 5.0|APG 5.0
15931156|NCT03410433|Device|ePTFE 5.0|ePTFE 5.0
15931157|NCT03410420|Drug|Pimonidazole hydrochloride|administration of pimonidazole-HCl
15931294|NCT03409315|Procedure|Centralized Therapeutic Drug Monitoring|Plasma samples will be drawn at peripheral centres en shipped to a central laboratory for analysis. Results and dosing advice will be returned by email to local physician.
15931158|NCT03410407|Other|Observation of CNS involvement|AML patients with CNS involvement defined by the confirmation of leukemic blast cells in the centrifuged cerebrospinal fluid (CSF) with the presence of more than five WBCs in the CSF or the detection of a CNS granulocytic sarcoma using computed tomography or magnetic resonance imaging.
15931159|NCT03410381|Other|Application EMMA|Emma proposes four types of assessments during 6 months:1) 5 times a day during 3 days, every month (5 minutes): patients can assess their emotions, their thoughts, their behavior and their occurrence context. 2) Weekly (7 minutes): consists of a summary of the week, about their emotions, thoughts, behavior, their relationships (family, work, friends, and their quality of life.3) Monthly (5 minutes): assessment of the usefulness and satisfaction about the application.4) Assessment available at any time An action plan is designed to support the participants, to help them facing difficult emotions and feelings, and to encourage them to ask for help. They can contact a relative or call the psychiatric emergency service directly by clicking on a button.
15931160|NCT03410368|Biological|NK cells|Autologous peripheral blood mononuclear cells (PBMCs) are collected by apheresis on D0, then induced into NK cells and infused into the patients 14 days later (D14) as the initial transfusion. There are 3 consecutive transfusion days (D14-D16). The second course of PBMCs collection started D14 before infusion. A total of 6 courses will be completed unless progression or unacceptable adverse events.
15931161|NCT03410355|Procedure|BMAC/PRP Injection|Patients will be placed on an office procedure under local anesthesia. The investigators will harvest 60 cm3 of bone marrow from posterior iliac crest and centrifuged obtaining approximately 3 cm3 of autologous bone marrow-mesenchymal stem cells concentrate. At the same time, 60cm3 of peripheral blood will be taken and centrifugated once, to obtain approximately 3 cm3 of PRP. After activation of platelet rich plasma cells they will be mixed in one syringe with the concentrated BMaC and both will be injected in the hip joint under ultrasound.
15931162|NCT03410355|Procedure|Cortisone Injection|An intraarticular injection of 1cm3 with 80mg of methylprednisolone combined with 3cm3 of 0.25% bupivacaine will be injected in the hip joint under ultrasound.
15931163|NCT03410342|Other|LFV|1 apple/banana/small bunch of grapes per day plus 1 portion of carrot/pepper/tomato per day
15931164|NCT03410342|Other|HFV|4 portions of fruits (apples, bananas, grapes, pears) plus 4 portions of vegetables (carrots, cucumber, sweet peppers, tomatoes), of commonly consumed types per day excluding citrus fruits, cruciferous and allium vegetables.
15931165|NCT03410342|Other|CC|4 portions of citrus fruits (clementines, grapefruits, lemons, oranges) plus 4 portions of cruciferous vegetables (broccoli, brussels sprouts, cauliflower, kale, savoy cabbage) per day.
15931166|NCT03410329|Other|Resistance training|Physical activity
15931167|NCT03410316|Other|No intervention|
15931168|NCT03410303|Diagnostic Test|Intraoperative ultrasound and 2 months post-operative ultrasound ( ± 1 month)|An ultrasound of the position of the prosthesis during surgery, under general anesthesia, is performed. A follow-up visit will be carried out 2 months (± 1 month) after the surgery as part of the usual care. An ultrasound of the position of the prosthesis is performed without anesthesia, either as part of the treatment or as part of the research. This measurement is performed without the intraoperative measurement by an independent sonographer.
15931169|NCT03410290|Other|Online Questionnaire|The online questionnaire includes questions about factors that impacted a patients diagnosis of vasculitis.
15931170|NCT03410277|Other|Experimental hypoglycemia|Experimental hypoglycemia with and without MRI
15931171|NCT03410264|Behavioral|CR-EXP|See arm/group descriptions
15931172|NCT03410264|Behavioral|EXP-CR|See arm/group descriptions
15931173|NCT03410264|Behavioral|Stress Management|See arm/group descriptions
15931174|NCT03410251|Procedure|Socket preservation|"Teeth were extracted atraumatically and without flap release in patients who have received prophylactic antibiotherapy and local anaesthesia. After checking the integrity of the buccal and palatal bone plate, biomaterial (Bio-Oss®) was introduced into the socket. A connective tissue graft harvested from the palate was inserted and sutured in buccal and palatal pouches in order to cover the socket.
~chlorhexidine spray (0.12%) twice a day and Ibuprofen 600 mg three times/ day were prescribed whereas antibiotics were continued for 5 days. Tooth brushing was banned at the extraction site for 10 days and sutures were removed 10 days after surgery."
15931175|NCT03410238|Behavioral|Saferteens Brief Intervention|A 30 minute private one-on-one brief motivational interviewing intervention administered by clinic staff. The goal of the intervention is to reduce and prevent youth violence using techniques to change behavior in a respectful, non-confrontational, and non-judgmental manner. This one-on-one counseling approach emphasizes individual choice and responsibility and differentiates between future goals/values and current behavior. In the 2 months following the intervention, participants will receive booster text messages tailored to their responses during the intervention.
15931176|NCT03410225|Behavioral|CAMI-TPP|The TPP group will receive four 30-minute sessions of one-on-one coaching over 12 weeks with a MI coach; the sessions will be guided by personalized feedback aimed at increasing condom use, supporting female partners in contraceptive use, and obtaining reproductive health services and STI testing. MI counseling sessions will be conducted by phone or video call.
15931177|NCT03410225|Behavioral|CAMI-Fitness|The Fitness group will also receive four 30-minute sessions of one-on-one coaching over 12 weeks with a MI coach; these sessions will be guided by personalized feedback aimed at healthy diet, physical activity and tobacco avoidance. MI counseling sessions will be conducted by phone or video call.
15931178|NCT03410212|Drug|Ketorolac Tromethamine|The 30mg/mL vial of Ketorolac will be injected as second inferior alveolar nerve block and the success of anesthesia will be evaluated using visual analog scale.
15931179|NCT03410212|Behavioral|Sham injection|In the control group, the sham injection will be provided at the same place of the first inferior alveolar nerve block but any injection would be done.
15931180|NCT03410173|Drug|Taurine|
15931181|NCT03410173|Drug|Placebo|
15931182|NCT03410160|Diagnostic Test|Clinical and biochemical examination.|Patients with chronic adrenal insufficiency were assessed by clinical and biochemical examination as well as questionnaire to evaluate the quality of hormone replacement therapy with glucocorticoids, education status, cortisol-metabolism, catecholamine deficit, chronic inflammation and variations of the glucocorticoid receptor.
15931332|NCT03408951|Other|Recording|The patient cutaneous ECG is recorded, to later be comparatively analysed by an expert and by the ISSD detection algorithm
15931500|NCT03407846|Procedure|Hystrectomy|Total laparscopic hystrectomy versus total abdominal hystrectomy
15931183|NCT03410147|Diagnostic Test|13C-octanoate breath test for gastric emptying|"The 13C-octanoate breath test for gastric emptying will be performed to assess gastric emptying rate of a liquid meal that is infused continuously over a period of 8 hour.
~13C-labeled sodium octanoate (food adjective) is mixed with liquid nutrients used for enteral feeding. The concentration of 13C-labeled sodium octanoate is according to the randomized treatment order. This mixture is infused at 20 ml/h for 8 hours (hourly dose of 13C-octanoate differs between treatment arms). In order to estimate gastric emptying rate quantitatively throughout the infusion period, the appearance of 13CO2 in the breath, relative to 12CO2, will be monitored by sampling the exhaled breath at a 15 minute interval.
~The aim is to induce a steady state hourly 13C-recovery. This would allow to implement the prolonged breath test protocol in future clinical investigations."
15931184|NCT03410134|Device|NeoMTA|NeoMTA™ Plus® root and pulp treatment material is a powder/gel system with no resin. The components are an extremely fine powder primarily tricalcium and dicalcium silicate plus a water-based gel.
15931185|NCT03410121|Device|IPolysite ® Mini série 3108 or Polysite ® Standard, série 4108.|Implantation of intravenous medical device in thoracic location
15931186|NCT03410121|Device|Vital Port®Minititanium|Implantation of intravenous medical device in humeral location
15931187|NCT03410108|Drug|Brigatinib|Brigatinib tablet
15931188|NCT03410095|Diagnostic Test|Brain MRI, cognitive testing, bloodwork|"Participants will undergo 3-Tesla MRI. Scan time will be about 1 hour and 15 minutes per subject per session at the Sunnybrook site. The protocol is designed to image SVD burden by quantifying PVS and WMH volumes, and image various physiological estimates on the brain.
~Participants will undergo the following cognitive tests: Behavioural Neurology Assessment-R (BNA-R), Montreal Cognitive Assessment (MOCA), Center for Epidemiologic Studies Depression Scale (CES-D), and BrainScreen.
~Blood samples will be assayed for inflammatory and endothelial function. Classical vascular risk factors will also be assessed. Once data collection is complete, DNA will be extracted from the frozen PBMC fraction and will be genotyped for APOE genotype and a panel of other single nucleotide polymorphisms known to be associated with cognition and cerebrovascular disease."
15931189|NCT03410082|Device|Titration under the guidance of BIS|The infusion rate of dexmedetomidine is increased by 0.1mcg/kg/h if BIS is greater than 80; The infusion rate is decreased by 0.1mcg/kg/h if BIS is less than 60.
15931190|NCT03410082|Diagnostic Test|Titration under the guidance of OAA/S|The infusion rate of dexmedetomidine is increased by 0.1mcg/kg/h if OAA/S is greater than 3; The infusion rate is decreased by 0.1mcg/kg/h if OAA/S is less than 3.
15931191|NCT03410069|Device|IKORUS UP system|Continuous assessment of the urethral microcirculation
15931192|NCT03410056|Drug|Efavaleukin alfa|Efavaleukin alfa administered as a subcutaneous injection.
15931193|NCT03410056|Drug|Placebo|Placebo administered as a subcutaneous injection.
15931194|NCT03410043|Drug|Osimertinib|Given PO
15931195|NCT03410043|Radiation|Radiation Therapy|Undergo radiation therapy
15931196|NCT03410043|Procedure|Therapeutic Conventional Surgery|Undergo surgery
15931197|NCT03410030|Drug|Ascorbic Acid|combination therapy
15931198|NCT03410030|Drug|Paclitaxel protein-bound|combination therapy
15931199|NCT03410030|Drug|Cisplatin|combination therapy
15931200|NCT03410030|Drug|Gemcitabine|combination therapy
15931202|NCT03410004|Drug|Chidamide|Chidamide 30mg orally BIW. Treatment cycles are repeated every 4 weeks.
15931204|NCT03409978|Device|in-Motion app|mobile phone application for recording fidgety movements at home
15931205|NCT03409965|Device|Lutronic Infini System|A microneedle radiofrequency device
15931206|NCT03409965|Device|Lutronic LaseMD System|A fractional thulium laser device
15931207|NCT03409952|Device|LaseMD and DUAL 1927nm Laser|Laser treatment of benign pigmented lesion based on photothermolysis whereby the target molecule, the chromophore, absorbs a delivered wavelength of light over a period of time to damage the target while limiting collateral damage to adjacent structures, leading to pigmentary clearance.
15931208|NCT03409952|Device|LaseMD|Laser treatment of benign pigmented lesion using optimized treatment settings.
15931209|NCT03409939|Dietary Supplement|Aromatic Amino Acid Intake|Intakes will be randomly chosen from a list of 8 doses of aromatic amino acids. Each intake will will be repeated approximately 4 times.
15931210|NCT03409926|Dietary Supplement|Acacia Gum|dietary supplement will be added to the participant's usual diet
15931211|NCT03409913|Radiation|FDG PET/CT|Conventional FDG PET/CT including head in order to asses cranial arteries.
15931212|NCT03409900|Other|LPB|The LPB will be performed in a lateral position, but modified to utilize ultrasound guidance to enhance our ability to quickly and safely locate the lumbar plexus as well as to avoid unblinding with regard to the traditional landmark LPB technique. For both LPB and QLB a TOTAL DOSE of 20 cc of the following local anesthetic mixture will be administered: Ropivacaine 0.2% and Epinephrine - 2.5 mcg/cc (1:400,000 concentration).
15931213|NCT03409900|Other|QLB|The QLB will be performed in a lateral position in a manner consistent with the technique first described by Børglum. For both LPB and QLB a TOTAL DOSE of 20 cc of the following local anesthetic mixture will be administered: Ropivacaine 0.2% and Epinephrine - 2.5 mcg/cc (1:400,000 concentration).
15931214|NCT03409887|Procedure|Intraorifice barrier of GIC|After primary root canal treatment, Glass Ionomer Cement (KetacTM Molar, 3M ESPE) applied as intraorifice barrier 3mm inside canal from root canal orifice in first group, as 2mm base on floor of pulp chamber in second group and direct composite restoration in 3rd group without Intraorifice barrier or base.
15931215|NCT03409887|Procedure|Base of GIC|After primary root canal treatment, Glass Ionomer Cement (KetacTM Molar, 3M ESPE) applied as intraorifice barrier 3mm inside canal from root canal orifice in first group, as 2mm base on floor of pulp chamber in second group and direct composite restoration in 3rd group without Intraorifice barrier or base.
15931405|NCT03408587|Biological|Ipilimumab|Fully human IgG1 monoclonal antibody that binds to the CTLA-4 receptor expressed on activated T cells.
15931406|NCT03408574|Drug|Nicotine patch, oral mecamylamine, placebo|Each participant randomly receives one active drug or placebo on each of three study days.
15931216|NCT03409887|Procedure|Direct composite restoration|After primary root canal treatment, Glass Ionomer Cement (KetacTM Molar, 3M ESPE) applied as intraorifice barrier 3mm inside canal from root canal orifice in first group, as 2mm base on floor of pulp chamber in second group and direct composite restoration in 3rd group without Intraorifice barrier or base.
15931217|NCT03409874|Other|Dry Needling|Dry needling to the muscle of mastication and temporomandibular joint capsule. 1-2 treatment sessions per week for up to 4 weeks
15931218|NCT03409874|Other|Spinal manipulation|Spinal manipulation, targeting the upper cervical spine (C1-C2, C2-C3 or OA). 1-2 treatments per week for up to 4 weeks.
15931219|NCT03409874|Other|Interocclusal Appliance|Interocclusal appliance worn every nights for 4 weeks.
15931220|NCT03409874|Drug|NSAIDs|diclofenac (Voltaren) 3 X 50mg per day for 4 weeks. If the patient's TMJ pain improves, the dosage may be reduced to 2 X 50mg per day.
15931221|NCT03409874|Other|TMJ Mobs|Temporomandibular joint mobilization targeting the temporomandibular joint capsule. 1-2 treatments per week for up to 4 weeks.
15931222|NCT03409848|Drug|Nivolumab|Addition of Nivolumab to Standard therapy (chemotherapy and Trastuzumab)
15931223|NCT03409848|Drug|Nivolumab|Chemo-free immunotherapy with Nivolumab, Ipilimumab, Trastuzumab
15931224|NCT03409848|Drug|Ipilimumab|Chemo-free immunotherapy with Nivolumab, Ipilimumab, Trastuzumab
15931225|NCT03409835|Drug|Ramosetron|Ramosetron 0.3 mg is administered after induction of general anesthesia.
15931226|NCT03409835|Drug|Normal saline|Normal saline 2 ml is administered after induction of general anesthesia.
15931227|NCT03409822|Device|Masimo SpHb™ monitor|Attach the Masimo Rainbow SET® Radical-7 ™ pulse oximeter probe to the third or fourth finger and perform a Masimo SpHb ™ monitor.
15931228|NCT03409809|Behavioral|Training|Level of Support: Intensive 2-day train-the-trainer workshop, facilitator guide and facilitator support website.
15931229|NCT03409809|Behavioral|Training and Technical Assistance|Level of Support: Intensive 2-day train-the-trainer workshop, facilitator guide, and facilitator support website, plus half-day implementation training to further define goals, needs, leadership structure and strategy for adoption and recruitment.
15931230|NCT03409809|Behavioral|Training, Tech. Assistance, Quality Assurance/Improvement|"Level of Support: As for Training and Technical Assistance arm, plus 1-year of technical assistance, coaching, and quality assurance to enhance skills for implementation and sustainability."
15931231|NCT03409796|Dietary Supplement|Gluten|Gluten powder.
15931232|NCT03409783|Device|ENSO Device|An active ENSO device that delivers neuromodulation therapy.
15931233|NCT03409783|Device|Sham Device|Sham Device
15931234|NCT03409770|Other|Therapeutic hypothermia|Whole body cooling using a servo controlled device
15931235|NCT03409757|Drug|Velphoro|4 weeks
15931236|NCT03409757|Other|saliva collection|2 samples
15931237|NCT03409757|Other|Supragingival biofilm collection|2 samples
15931238|NCT03409757|Other|stool collection|2 samples
15931239|NCT03409757|Other|blood collection|2 samples
15931240|NCT03409744|Drug|evinacumab|Intravenous (IV) administration
15931241|NCT03409731|Device|ABSORB GT1 BVS|Patients receiving Absorb GT1 BVS
15931242|NCT03409718|Device|Biomet Comprehensive Shoulder System|Total shoulder system designed to provide intraoperative flexibility for surgeons with unmatched humeral stem options, and infinite humeral head offset possibilities while meeting the growing demand for ease of glenoid preparation through a streamlined, low-profile, cannulated instrument platform
15931243|NCT03409705|Dietary Supplement|Skate Skin group|2,000 mg of low-molecular collagen peptide was orally administered per day for 12 weeks.
15931244|NCT03409705|Dietary Supplement|Control group|2,000 mg of starch was orally administered per day for 12 weeks.
15931245|NCT03409692|Diagnostic Test|Gene Expression Profiling|SkylineDx has previously developed the MMprofiler, a microarray-based diagnostic test that can subtype MM patients and reliably predict MM patient survival (prognosis). In this project, the test's clinical value will be expanded to include the prediction of treatment effectiveness in individual patients based on Gene Expression Profiling.
15931246|NCT03409679|Drug|Murepavadin|Murepavadin IV every 8 hours + 1 anti-pseudomonal antibiotic (Piperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin)
15931247|NCT03409679|Drug|Two anti-pseudomonal antibiotics|Piperacillin-tazobactam, ceftazidine, cefepime, meropenem, amikacin, ciprofoxacin, levofloxacin, colistin
15931248|NCT03409666|Device|Taperloc Complete Microplasty stem|Total hip replacement with Taperloc Complete Microplasty stem and G7 acetabular shell with E1 liner
15931249|NCT03409666|Device|Taperloc Complete Reduced Distal stem|Total hip replacement with Taperloc Complete Reduced Distal stem and G7 acetabular shell with E1 liner
15931250|NCT03409627|Biological|INXN-4001|Retrograde coronary sinus infusion of triple effector plasmid (INXN-4001)
15931251|NCT03409614|Drug|REGN2810|REGN2810 plus Platinum-based doublet chemotherapy Part 1 and Part 2
15931252|NCT03409614|Drug|REGN2810/chemo/ipi|REGN2810 plus abbreviated chemotherapy plus Ipilimumab Part 1
15931253|NCT03409614|Other|Chemotherapy|Platinum-based doublet chemotherapy Part 1
15931254|NCT03409614|Drug|Placebo|Matching placebo Part 2
15931255|NCT03409601|Other|100% Portion Size|Meal portion size at baseline
15931256|NCT03409601|Other|125% Portion Size|Meal portion size 125% of baseline
15931257|NCT03409601|Other|150% Portion Size|Meal portion size 150% of baseline
15931258|NCT03409601|Other|175% Portion Size|Meal portion size 175% of baseline
15931259|NCT03409588|Drug|Adempas|After obtaining baseline data, patients will be placed on oral riociguat at a dose of 0.5 mg TID which will be up titrated over two months to a maximum dose of 2.5 mg TID or maximum tolerated dose. After 3 months from onset of riociguat initiation, the University of California San Diego (UCSD) shortness of breath score, 6 Minute Walk Test (6MWD), and resting/exercise Right Heart Catheterization (RHC) will be repeated.
15931293|NCT03409328|Behavioral|HIV and substance use prevention|The intervention content will be developed through formative research during the initial phase of the study. However, the intervention will address: bisexual-inclusive sexual health education, unique influences of risk behavior among bisexual adolescents, and skills to cope with bisexual stigma and to increase acceptance of one's bisexual identity.
15931407|NCT03408561|Other|Internet-Based Intervention|Receive message via Twitter
15931260|NCT03409575|Other|5 minutes stimulation|Before the NMES application, warming exercises will be performed on the lower extremity muscles for 5 minutes. NMES will be administered through Compex device (Physio, Chattanooga Corporation, Chattanooga, U.S.A.). Quadriceps will be stimulated bilaterally for 3 sessions per week for 6 weeks (totally 18 sessions). Four electrodes will be used on the femoral nerve, and motor points of the rectus femoris, vastus medialis, lateralis.The biphasic, symmetrical waveform will be used. The 100 Hz current will be applied for 5 minutes by 5 sec on: 15 sec off and than the muscle will be rested for 10 minutes. 5 minutes of NMES will be made in 4 sets. Fifteen contractions will be received at each set. The intensity of the current will be increased until the visible contraction is taken.
15931261|NCT03409575|Other|10 minutes stimulation|Before the NMES application, warming exercises will be performed on the lower extremity muscles for 5 minutes. NMES will be administered through Compex device (Physio, Chattanooga Corporation, Chattanooga, U.S.A.). Quadriceps will be stimulated bilaterally for 3 sessions per week for 6 weeks (totally 18 sessions). Four electrodes will be used on the femoral nerve, and motor points of the rectus femoris, vastus medialis, lateralis.The biphasic, symmetrical waveform will be used. The 100 Hz current will be applied for 10 minutes by 5 sec on: 15 sec off and than the muscle will be rested for 10 minutes. 10 minutes of NMES will be made in 2 sets. Thirty contractions will be received at each set. The intensity of the current will be increased until the visible contraction is taken.
15931262|NCT03409562|Behavioral|motor control training|Exercises to strengthen the lumbar musculature and control the posture.
15931263|NCT03409562|Behavioral|pain neurophysiology education|Educational sessions to improve patient's neurophysiology of pain knowledge.
15931264|NCT03409549|Radiation|Fluciclovine PET/CT|Fluorine-18 Fluciclovine PET/CT scan of the brain
15931265|NCT03409536|Device|SSEP monitoring|Participants will be monitored using the SSEP device both before and after induction of a brachial plexus block.
15931266|NCT03409510|Radiation|UVB radiation|"UVB treatment regimen:
~Week 1-2: 0.85 kilo Joule/m2 twice per week Week 3-7: 0.85 kilo Joule/m2 three times per week Week 8-9: 1.4 kilo Joule/m2 three times per week"
15931267|NCT03409497|Other|Concord Grape Juice|Concord Grape Juice
15931268|NCT03409497|Other|Low flavonoid low essence beverage|Low flavonoid low essence beverage
15931269|NCT03409497|Other|Low flavonoid beverage|Low flavonoid beverage
15931270|NCT03409484|Other|Concord Grape Juice|Concord Grape Juice
15931271|NCT03409484|Other|Low flavoniod low essence beverage|Low flavoniod low essence beverage
15931272|NCT03409484|Other|Low flavonoid beverage|Low flavonoid beverage
15931273|NCT03409471|Device|Flocked Swab|At the colposcopy clinic, vaginal self-sample will be collected with the Flocked Swab (Noble Bioscience, Inc., Korea).
15931274|NCT03409471|Device|Cervical Brush|Physician collected cervical sample will be collected also at the colposcopy center with the Cervical Brush (Noble Bioscience, Inc., Korea).
15931275|NCT03409471|Diagnostic Test|HPV assay|The hrHPV assay used, will be the Roche Cobas® 4800 HPV test, Anyplex™ II HPV HR detection kit and Realtime HPV HR-S Detection kit.
15931276|NCT03409458|Drug|PT-112|The MTD and RP2D of PT-112 when used in combination with avelumab will be determined during dose escalation.
15931277|NCT03409458|Biological|avelumab|Avelumab will be administered at a fixed dose of 800 mg.
15931278|NCT03409445|Other|no intervention|no intervention (observational study)
15931279|NCT03409432|Drug|Brentuximab Vedotin|Given IV
15931280|NCT03409432|Other|Laboratory Biomarker Analysis|Correlative studies
15931281|NCT03409432|Drug|Lenalidomide|Given PO
15931282|NCT03409419|Drug|[18F] CFA|pilot study to evaluate the bio-distribution of [18F] CFA, a new tracer for imaging the purine nucleoside biosynthetic pathway, before and after immunotherapy treatment in patients with metastatic or recurrent advanced melanoma.
15931283|NCT03409406|Behavioral|Caregiver Intervention|This intervention is a 3-month (or 12 weeks) sequenced mobile health intervention provided to the parent/caregiver to use at home with the child. It supplements the 30 minute speech and language therapy session provided to the child at the hospital once a month
15931284|NCT03409406|Behavioral|ST Intervention|This intervention is the 30 minute speech and language therapy session provided to the child at the hospital once a month for three months.
15931285|NCT03409393|Other|The COPUS intervention|The COPUS intervention consists of 8 weeks of High-Intensity Functional Training (HIFT). The frequency of the training is 3 sessions per week and the duration is one hour per session. The intervention is group-based and supervised. Each training session includes warm-up (15 min), followed by 30 minutes of HIFT based on a range of varied functional exercises, including elements of strength training and aerobic exercise. The sessions are supervised by a trained physiotherapist and exercise physiologist supported by 2 two trained bachelor students in Sports Science.
15931286|NCT03409393|Other|Usual Care (OPUS treatment)|Usual care include specialised early intervention treatment (OPUS treatment) and consists of three main pillars: modified assertive treatment, family involvement, and social skill training. OPUS treatment is delivered via multidisciplinary teams include psychiatrists, psychologists, nurses, social workers, physiotherapists, and vocational therapists. All team members, except for the psychiatrist, function as case managers. The ratio of patients to case managers must not exceed 12:1.
15931287|NCT03409380|Dietary Supplement|Arginine Drink|10 g of arginine in a formulated drink
15931288|NCT03409380|Dietary Supplement|Plain Drink|formulated drink
15931289|NCT03409367|Other|Participant choice of over-the-counter emollients: Vaseline, Vanicream, CeraVe Healing Ointment, CeraVe cream, Cetaphil cream|Lipid-rich emollient serving as skin barrier
15931290|NCT03409354|Behavioral|Tele-rehabilitation|There are five different categories of exercise in the rehabilitation program, which combines both physiotherapy (Category 1 to 4) and occupational therapy components (Category 5). Each tele-therapy session could cover all five categories of exercises. Progression of levels within each exercise within each category should be determined by the tele-therapist and in consultation with the participant.
15931291|NCT03409354|Behavioral|Usual care|Usual rehabilitation care (e.g., PT, OT and ST), prescribed by rehabilitation therapists at participating centers and performed by participants at participating centers.
15931292|NCT03409341|Other|Blood and tumor tissue analysis, Clinical response.|DNA sequencing and functional testing of peripheral blood mononuclear cells. DNA and RNA sequencing and immune cell analysis of tumor. Clinical response at 12 months.
15931408|NCT03408561|Other|Survey Administration|Ancillary studies
15931295|NCT03409302|Behavioral|ALGEApp (Brief iACT intervention)|Participants will be randomly assigned to one of the two groups: brief i-ACT intervention or active control group. The i-ACT intervention participants will be encouraged to login the website platform with their credentials and to complete 4 weekly sessions (1 session per week) which lasts about 1 hour each. Participants will be guided by a 3D- animated Avatar who adopts the role of a facilitator.
15931296|NCT03409302|Behavioral|Active control group|Participants will be randomly assigned to one of the two groups: brief i-ACT intervention or active control group. The active control group will have access, through the same platform. only to limited online psycho-educational information regarding pain. Active control group will complete pre-treatment and post-treatment questionnaires in parallel with the intervention group.
15931297|NCT03409289|Device|RUSH Exam|Within two hours of return of spontaneous circulation, the following elements of the RUSH exam will be performed: focused evaluation of the heart, inferior vena cava, abdomen and aorta with the addition of evaluation for DVT and ocular ultrasound.
15931298|NCT03409276|Biological|env (A,B,C,A/E)/gag (C) DNA Vaccine|Administered by intramuscular injection in the deltoid.
15931299|NCT03409276|Biological|gp120 (A,B,C,A/E) Protein Vaccine|Administered by intramuscular injection in the deltoid.
15931300|NCT03409276|Biological|Placebo|Sodium Chloride for Injection, USP 0.9%; Administered by intramuscular injection in the deltoid.
15931301|NCT03409276|Biological|GLA-SE adjuvant|Administered by intramuscular injection in the deltoid.
15931302|NCT03409263|Other|Observational study|Not applicable (observational registry study)
15931303|NCT03409250|Drug|Ranibizumab, Lucentis|Intravitreal injection with Lucentis (Ranibizumab)
15931304|NCT03409237|Drug|Mannitol|Therapy is administered according to the clinical gold standard and until reaching and maintaining serum sodium levels between 145 e 155 meq/l and an osmolarity <320.
15931305|NCT03409237|Drug|Hypertonic saline solution|Therapy is administered according to the clinical gold standard and until reaching and maintaining serum sodium levels between 145 e 155 meq/l and an osmolarity <320.
15931306|NCT03409211|Dietary Supplement|PEVCO|All subjects will receive PEVCO for 6 more weeks.
15931307|NCT03409211|Dietary Supplement|Dietary Supplement Capsules without Coconut Oil|All subjects will receive placebo (PBO) for 3 weeks
15931308|NCT03409198|Drug|Ipilimumab|Ipilimumab blocks CTLA-4 and may deplete regulatory T cells
15931309|NCT03409198|Drug|Nivolumab|Nivolumab blocks PD-1 and thereby enhances the effector phase of the immune reaction, by enabling T cells to kill tumor cells and engage effectively with other PD-L1 expressing targets.
15931310|NCT03409198|Drug|Pegylated liposomal doxorubicin|Chemotherapy
15931311|NCT03409198|Drug|Cyclophosphamide|Chemotherapy
15931312|NCT03409185|Device|Alcon 1 piece SA60AT lens|Optic Diameter: 6.0 mm, Overall length: 13.0 mm, Material: Ultraviolet-absorbing Acrylate/Methacrylate Copolymer
15931313|NCT03409185|Device|AMO 1-piece AABOO lens|Optic Diameter: 6.0 mm, Overall length: 13.0 mm, Material: Ultraviolet-blocking hydrophobic acrylic
15931314|NCT03409172|Other|CTR|no counseling or nutritional therapy and no exercise
15931315|NCT03409172|Other|MICT|no counseling or nutritional therapy. 8 weeks of individualized and supervised ergometer-based moderate continuous intensity training (MICT).
15931316|NCT03409172|Other|HIIT|no counseling or nutritional therapy. 8 weeks of individualized and supervised ergometer-based high intensity interval training (HIIT)
15931317|NCT03409159|Device|LAAC|Left atrial appendage closure
15931318|NCT03409146|Device|Monica Novii Wireless Patch System|The Monica Novii Wireless Patch System is a transabdominal fetal/maternal recorder that provides fetal heart rate, maternal heart rate and maternal uterine activity contractions.
15931319|NCT03409133|Device|Multi contact electrode implant|See Arm Description
15931320|NCT03409120|Device|Boston Scientific Vercise PC IPG with directional DBS lead|We will contrast the effects of omnidirectional versus directional STN DBS on dystonia symptoms in patients with PD.
15931321|NCT03409107|Drug|Daprodustat (GSK1278863)|Daprodustat will be available as 9 millimeter (mm) or 7 mm film-coated tablets. Daprodustat will be administered once daily via oral route and can be taken without regard to food.
15931322|NCT03409107|Drug|Placebo|Daprodustat matching placebo will be available as 9 mm or 7 mm film coated tablets. Placebo will be administered once daily via oral route and can be taken without regard to food.
15931323|NCT03409107|Drug|Iron therapy|Iron therapy will be administered if ferritin is <50 Nano gram per milliliter and/or TSAT is <15 percent.
15931324|NCT03409081|Drug|gilteritinib|oral
15931325|NCT03409068|Procedure|C2-C4 compartment anesthetic block|C2-C4 compartment anesthetic block is performed by injecting levobupivacaine 0.375% 20 mL between the posterior face of the middle scalenus muscle, the anterior face of the posterior scalene muscle and the lower plane of the sternoscleidomastoid muscle.
15931326|NCT03409068|Procedure|Costagliola block|Costagliola block is performed by injected by injecting levobupivacaine 0.375% 20 mL along the anterior and the posterior border of sternocleidomastoid muscle
15931327|NCT03409042|Behavioral|Caloric compensation|The investigators have adapted an established within-subject preload paradigm to assess infant's short term caloric compensation. At each studied age, the measure of caloric compensation required two visits at the laboratory on two non-consecutive days. On the first visit, the infants received a fixed amount of a food preload either low or high in energy density. The order of the two preloads was counterbalanced. After a delay (ranging from several hours in the 3-4 months old infants to 25 min in 10.5- and 14.5-month-old infants), the infants were served an ad libitum meal. Weight intakes (g) were assessed by weighing each bottle/bowl before and after consumption.
15931328|NCT03409029|Diagnostic Test|MRI Scan|Additional imaging using MRI scan
15931329|NCT03409016|Other|Blood Testing|Patients will undergo therapy per standard protocol. There are no study-related medications or interventions beyond blood testing.
15931330|NCT03408977|Other|probe meal|The probe meal will be served in 150 Kcal portions (10 g foie, 10 g cheese, 5 g chips, 2 g peanuts, 3 g toast, and 27 mL soft drink) up to the level of maximal satiation.
15931331|NCT03408964|Other|biological samples collection and analysis|Participants to the study will be assigned to 4 cohorts according to the stage of disease and planned antitumor treatment at time of study entry; they will be followed up and sampled according to a defined time schedule
15931409|NCT03408548|Procedure|Scaling root planning|Periodontal treatment
15931333|NCT03408938|Device|of Masimo Radical-7¿ Pulse CO-Oximeter|"The Masimo pulse oximetry model:
~The pulse oximetry model which Masimo developed accounts for saturation values contributed by the true arterial signal, and by one or more motion or noise signals. lt is assumed that under conditions of motion, the detected IR and RD signals comprise both the true arterial saturation signal and a venous (or non-arterial) motion noise signal. Masimo uses a highly sophisticated adaptive filter with, Discrete saturation transform (DST) four other parallel engines, to leverage each algorithm's unique strengths to ensure accurate readings through all patient conditions. Masimo SET's most powerful algorithm is Signal extraction technology (SET). All algorithms depend upon assumptions. The more assumptions, the weaker the algorithm. DST makes only one assumption -that arterial blood has a higher oxygenation than venous - making it the most powerful pulse oximetry algorithm"
15931334|NCT03408925|Other|Exercise program|The orienteerers are asked to perform specific exercises four times a week throughout the entire study period. The exercises are heel rises, runners pose, single leg stance and one-leg jumps with three difficult levels aiming to mainly improve lower extremity strength and neuromuscular function. Each second week the exercises' difficulty level is increased.
15931335|NCT03408912|Diagnostic Test|FFR|FFR from CMR compared to invasive FFR
15931336|NCT03408899|Drug|PC-1005 gel|PC-1005 (0.002% MIV-150/0.3% zinc acetate in 3.0% carrageenan gel) in 4 mL, 16 mL, and 32 mL doses administered rectally.
15931337|NCT03408886|Drug|Vancomycin|Oral vancomycin is administered to reduce pathogenic bacteria.
15931338|NCT03408886|Drug|MoviPrep|MoviPrep is given at the end of vancomycin therapy to remove the vancomycin and remaining bacteria prior to administering Full-Spectrum Microbiota
15931339|NCT03408886|Biological|Full Spectrum Microbiota|Gut bacteria from healthy human donors are administered orally in a pill form
15931340|NCT03408873|Drug|Abilify Maintena|Drug is in an injectable form and will be administered approximately every four weeks through Week 24 of the study. Dosage is per package insert or at the discretion of the psychiatrist.
15931341|NCT03408873|Behavioral|Customized Adherence Enhancement (CAE)|CAE targets key areas relevant to non-adherent populations with schizophrenia or schizoaffective disorder: 1) inadequate or incorrect understanding of mental disorder; 2) lack of medication-taking routines; 3) poor communication with care providers; and 4) substance use which interferes with adherence and healthy behaviors that promote recovery. CAE is delivered based upon initial assessment of reasons for non-adherence and only those components of CAE that are determined to be indicated for that individual are delivered (psychoeducation, modified motivational interviewing, assistance with medication routines, coaching in communication with providers).
15931342|NCT03408860|Other|Countering Emotional Behaviors Module from Unified Protocol|This is a 4-week behavioral treatment that teaches patients to counter problematic emotional avoidance by approaching behaviors and situations that may bring up strong emotions in the short-term, but prevent interfering emotional difficulties in the long-term.
15931343|NCT03408847|Combination Product|Beclomethasone dipropionate in addition to MC-EVOO|Oral beclomethasone dipropionate at dose of 10 mg / day for the first 4 weeks, 5 mg / day for the second 4 weeks plus MC- EVOO for 12 weeks at a dose of 2 tablespoons per day (1 before lunch and 1 before dinner). Each spoon will contain 10 grams of oil containing 5 mg of biophenols.
15931344|NCT03408847|Combination Product|Beclomethasone dipropionate in addition to refined oil|Oral beclomethasone dipropionate (10 mg / day for the first 4 weeks, 5 mg / day for the second 4 weeks) plus placebo consisting of refined olive oil with low biophenols.
15931345|NCT03408834|Other|pulse variability index|fluid management with pulse variability index or conventional
15931346|NCT03408821|Other|Problem Solving Therapy (PST)|Participants will attend 8 weekly session of Case Manager (CM) implemented PST, a form of group talk therapy.
15931347|NCT03408808|Procedure|Platelet rich plasma|Aspiration of ganglion and injection with platelet rich plasma.
15931348|NCT03408808|Procedure|Aspiration alone|Aspiration of the ganglion
15931349|NCT03408795|Procedure|Laparoscopic distal gastrectomy|Longitudinal testing of The Japanese Operative Rating Scale for Laparoscopic Distal Gastrectomy
15931350|NCT03408782|Procedure|Insertion of drainage|
15931351|NCT03408769|Other|Medical questionnaire|"Brief Index of Sexual Functioning for Women questionnaire
~Quality of life questionnaire (EORTC QLQ-BR23)
~Partnership questionnaire (partnerschaftsfragebogen; PFB)
~Short interview about their sexual intimacy"
15931352|NCT03408756|Drug|methotrexate|Participants will receive methotrexate through oral or subcutaneous route of administration
15931353|NCT03408743|Behavioral|Knowledge Alone|Increase knowledge relate d STIs, STI risk, alcohol impairment, condom use skills, alcohol use behavior tracking skills, testing & treatment services.
15931354|NCT03408743|Behavioral|Self-efficacy alone|Increase self-efficacy to us e protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15931355|NCT03408743|Behavioral|Perceived benefits alone|Increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
15931356|NCT03408743|Behavioral|Benefits and self-efficacy|Increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15931357|NCT03408743|Behavioral|Injunctive norms alone|Correct misperceptions regarding approval of alcohol misuse & sexual risk taking.
15931358|NCT03408743|Behavioral|Injunctive norms and self-efficacy|Correct misperceptions regarding approval of alcohol misuse & sexual risk taking and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15931359|NCT03408743|Behavioral|Injunctive norms and benefits|Correct misperceptions regarding approval of alcohol misuse & sexual risk taking and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15931410|NCT03408548|Dietary Supplement|Probiotic|two lozenge per day containing Bifidobacterium animalis lactis HN019
15931411|NCT03408548|Other|Placebo|two lozenge per day not containing Bifidobacterium animalis lactis HN019
15931412|NCT03408535|Other|Eriksholm Guide to Better Hearing|Online rehabilitation program.
15965520|NCT03146416|Drug|Evinacumab|SC or IV administration of Evinacumab
15931360|NCT03408743|Behavioral|Injunctive norms, benefits, self-efficacy|Correct misperceptions regarding approval of alcohol misuse & sexual risk taking; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15931361|NCT03408743|Behavioral|Descriptive norms alone|Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors.
15931362|NCT03408743|Behavioral|Descriptive norms and self-efficacy|Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15931363|NCT03408743|Behavioral|Descriptive norms and perceived benefits|Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
15931364|NCT03408743|Behavioral|Descriptive norms, benefits, self-efficacy|Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15931365|NCT03408743|Behavioral|Descriptive norms and injunctive norms|Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors and correct misperceptions regarding approval of alcohol misuse & sexual risk taking.
15931366|NCT03408743|Behavioral|Descriptive and injunctive norms, self-efficacy|orrect misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15931367|NCT03408743|Behavioral|Descriptive and injunctive norms, and benefits|Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
15931368|NCT03408743|Behavioral|Descriptive & injunctive norms, benefits, efficacy|Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and Increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15931369|NCT03408743|Behavioral|Expectancies alone|Decrease the expectation that alcohol is needed to have good sexual encounter.
15931370|NCT03408743|Behavioral|Expectancies and self-efficacy|Decrease the expectation that alcohol is needed to have good sexual encounter and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15931371|NCT03408743|Behavioral|Expectancies and perceived benefits|Decrease the expectation that alcohol is needed to have good sexual encounter and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
15931372|NCT03408743|Behavioral|Expectancies, benefits, self-efficacy|Decrease the expectation that alcohol is needed to have good sexual encounter; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15931373|NCT03408743|Behavioral|Expectancies and injunctive norms|Decrease the expectation that alcohol is needed to have good sexual encounter and correct misperceptions regarding approval of alcohol misuse & sexual risk taking.
15931374|NCT03408743|Behavioral|Expectancies, injunctive norms, self-efficacy|Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15931375|NCT03408743|Behavioral|Expectancies, injunctive norms, and benefits|Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
15931376|NCT03408743|Behavioral|Expectancies, injunctive norms, benefits, efficacy|Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15931377|NCT03408743|Behavioral|Expectancies and descriptive norms|Decrease the expectation that alcohol is needed to have good sexual encounter and correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors.
15931378|NCT03408743|Behavioral|Expectancies, descriptive norms, & self-efficacy|Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15931379|NCT03408743|Behavioral|Expectancies, descriptive norms, benefits|Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
15931380|NCT03408743|Behavioral|Expectancies, descriptive norms, benefits, efficacy|Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15931381|NCT03408743|Behavioral|Expectancies, descriptive and injunctive norms|Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; and correct misperceptions regarding approval of alcohol misuse & sexual risk taking.
15931382|NCT03408743|Behavioral|Expectancies, descriptive & injunctive norms, efficacy|Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15931383|NCT03408743|Behavioral|Expectancies, descriptive & injunctive norms, benefits|Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
15931384|NCT03408743|Behavioral|Expectancies, descriptive & injunctive, benefits, efficacy|Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15931385|NCT03408730|Biological|Hepatitis B Vaccination|Hepatitis B Vaccination
15931386|NCT03408717|Other|Questionnaires|Questionnaires including Pain catastrophizing scale (PCS), Central Sensitisation Inventory (CSI), Coping Strategies Questionnaire-Revised (CSQ-R), Brief Symptom Inventory-18 (BSI-18), Perceived Stress Scale (PSS), EQ-5D-3L and Eysenck Personality Questionnaire (EPQ) will be administered to the patient.
15931387|NCT03408717|Other|Mechanical Temporal Summation assessment|A 180 gram von Frey filament is applied on the subject's forearm. Patient will then be asked to rate the pinprick pain score on a verbal rating scale, 0-100. Following this, 10 consecutive touches at random locations are applied with a 1 second interstimulus interval and within a 1 cm diameter circle. The patient will then be asked to rate the 10th pain score (0-100). The Mechanical Temporal Summation Score is obtained by the difference between the 11th pain score and the 1st pain score. If the score is greater than zero, the patient is implied to have presence of Mechanical Temporal Summation.
15931388|NCT03408717|Other|Pain threshold assessment|Pressure is applied 90 degree straight down force on the subject's right/left centre of the trapezius muscle using an algometer, with a speed of pressure ~ 1kgf/s. The above procedure is then repeated 3 times at each site (left/right) which is indicated on the pressure mark with each time having the reading recorded. When patient shows no response ≥ 6kgf, the threshold is recorded as 6kgf. The patient upon feeling pain will say stop or raise the hand to terminate the test. The mean value is obtained by averaging the readings and will then be recorded as the threshold estimate.
15931389|NCT03408704|Other|ASP|"It consists of one educational session where doctors and staff at the center discuss current guidelines around management of patients attending for a sore throat. At the education the following is discussed:
~The Swedish guidelines
~Example of cases
~Statistics from previous 6 month showing how well this clinic adheres to the Swedish guidelines."
15931390|NCT03408691|Dietary Supplement|Fresh fermented dairy drink containing probiotic strain|Fresh fermented dairy drink containing probiotic strain consumed as follows: one bottle (100g) BID for 6 weeks.
15931391|NCT03408691|Other|Acidified dairy drink without ferment|Acidified dairy drink without ferment consumed as follows: one bottle (100g) BID for 6 weeks.
15931394|NCT03408639|Drug|CinnaPoietin®|The starting dose of Erythropoietin is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropoietin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients' response.
15931395|NCT03408639|Drug|Eprex®|The starting dose of Erythropoietin is 60 (50-100) IU/kg body weight/week for naïve patients. Administration dose for patients who are treated with erythropoietin is similar dose of previously administered amount (IV or SC without any change). After then, dose adjustment will be done based on patients' response.
15931396|NCT03408639|Drug|Nephrovit|Nephrovit tablet is daily administered to all the patients.
15931397|NCT03408639|Drug|Vitamin B12 Injection|Vitamin B12 is monthly injected to all the patients.
15931398|NCT03408626|Drug|Papain-based Chemo-mechanical caries removal agent|Birx 3000 and the exclusive Encapsulating Buffer Emulsifier (EBE) technology claim it has effective and selective proteolytic action to remove collagen fiber in the carious tissue. It has an antibacterial and antifungal power, thus it has an antiseptic power at the tissue level .furthermore, this gel does not contain chloramines in its formula, which enhances its toxicological safety feature.
15931399|NCT03408626|Device|conventional rotary|traditional rotary method
15931400|NCT03408613|Procedure|Positive Airway Pressure|See arm/group description
15931401|NCT03408613|Procedure|Supplemental Oxygen|See arm/group description
15931402|NCT03408613|Procedure|Sham|See arm/group description
15931403|NCT03408600|Other|Management|To evaluate vital signs in a global cohort of patients with acute peritonitis, determining which parameters are statistically significant to predict in-hospital mortality and ICU admission.
15931404|NCT03408587|Biological|CVA21|Oncolytic virus
15931413|NCT03408509|Behavioral|Computerized cognitive training|Posit Science Inc. will supply the software for the computerized cognitive training through the platform BrainHQ, which is available on line. The training program consists of a set of computerized exercises designed to improve the speed and accuracy of sensory information processing while engaging neuromodulatory systems involved in attention and reward. The rationale is that, in order to understand and remember information, the brain must first generate precise and reliable neurological responses that represent the sensory stimuli. These exercises continuously adjust the difficulty level to user performance to maintain an approximately 85% rate of correct responses. Trials with correct responses are rewarded with points and animations. The goal is to increase the effectiveness with which these stimuli engage and drive plastic changes in brain systems. Engagement is monitored by electronic data upload following each training session.
15931414|NCT03408496|Other|Myofascial release|Manual therapy
15931415|NCT03408496|Other|Muscle stretching|Muscle stretching
15931416|NCT03408496|Other|Control|Medical appointment
15931417|NCT03408483|Drug|Quadratus Lumborum Block (QLB)|Under ultrasound guidance, the needle will be advanced to the posterior border of the quadratus lumborum muscle. After negative aspiration, a bolus of 40 mL of 0.25% bupivacaine with 1:400,000 epinephrine will be injected in 5 mL aliquots, ensuring proper placement of needle tip and appropriate spread of local anesthetic.
15931418|NCT03408483|Drug|Standard of Care|This is currently the standard of care, no local anesthetic will be injected. Pain will be managed with parenteral and oral medication.
15931419|NCT03408470|Drug|TD-1473 oral capsule|(Intervention description included in arm description)
15931420|NCT03408470|Drug|[14C]-TD-1473 IV bolus|(Intervention description included in arm description)
15931421|NCT03408470|Drug|[14C]-TD-1473 Oral Capsule|(Intervention description included in arm description)
15931422|NCT03408457|Procedure|Blood sampling after antibiotic administration|Sampling of 6 x 8 mL (in sum 48 mL) via the central venous line (established for the surgical procedure) until postoperative day 2
15931423|NCT03408431|Device|Ambu® AuraGain™|Ambu® AuraGain™ laryngeal mask will be placed first, and then, a lubricated endotracheal tube will be gently intubated through the laryngeal mask under each position according to the assigned group.
15931424|NCT03408431|Procedure|neck extension|Patients' neck will be maximally extended (~60°) during blind intubation.
15931425|NCT03408418|Procedure|Platelet-rich fibrin|The use of autologous platelet-rich fibrin after tooth extraction to promote bone healing and alveolar ridge preservation
15931426|NCT03408405|Drug|Acthar Gel 80 UNT/ML Injectable Solution|Participant will self inject 'Acthar Gel 80 UNT/ML Injectable Solution' 2 x per week for six months.
15931427|NCT03408392|Drug|Test formulation A|Test formulation: SKF101804 will be available as oral suspension supplied as powder for reconstitution (Off-white to cream coloured powder). Subjects will receive single dose of 5 mL of suspension thus receiving 200 mg dose of cefixime. The suspension is a white to off white viscous suspension with a fruit flavor and odor.
15931428|NCT03408392|Drug|Reference formulation B|Reference formulation will be available as oral suspension supplied as powder for reconstitution (Off-white to cream coloured powder). Subjects will receive single dose of 5 mL of suspension thus receiving 200 mg dose of cefixime. The suspension is a white to off white viscous suspension with a strawberry flavor and odor.
15931429|NCT03408379|Other|Collection of blood sample in aneurysm|"In case of an endovascular treatment :
~A blood sample (venous or arterial) of 10 ml will be taken at the beginning of the procedure, an intra aneurysmal blood sample (1mL) will be taken during the procedure and a blood sample (arterial) of 1 mL will be taken at the end of the procedure.
~Iterative blood samples (arterial) of 10 mL will be taken at each follow up visit.
~In case of a surgery treatment :
~A blood sample (venous or arterial) of 10 ml will be taken at the beginning of the surgery.
~A Tissue sample will be taken during the surgery
~Iterative blood samples (arterial) of 10 mL will be taken at each follow up visit."
15931430|NCT03408366|Procedure|Laparotomy|Laparotomy via vertical midline incision and after the planned surgical procedure is complete.
15931431|NCT03408366|Other|ICG|ICG will be injected intravenously ICG is a fluorescent iodide dye.
15931432|NCT03408366|Other|Spectrum NIR imaging system|The Spectrum NIR imaging system uses a handheld camera that emits light in the NIR range.
15931433|NCT03408353|Procedure|Biospecimen Collection|Undergo collection of blood samples
15931434|NCT03408353|Procedure|Mammography|Undergo standard of care mammography
15931435|NCT03408353|Other|Questionnaire Administration|Complete questionnaires
15931436|NCT03408340|Procedure|Paravertebral Nerve Block|Participants will be induced for anesthesia with propofol 3 milligram/kilogram (mg/kg) or ketamine 2mg/kg (if there is intravenous (IV) access) or sevoflurane with 1 microgram/kilogram (mcg/kg) of fentanyl and 1.2 mg/kg rocuronium once IV access is established. A NIRS pad will be used for cerebral oximetry as well as another NIRS pad for spinal cord oximetry. The patient will be intubated, and then will be positioned laterally for the nerve block at approximately the left T3-4 level. A linear ultrasound probe with a sterile sheath will be used to provide imaging for the paravertebral nerve block. The injected solution will be 1 milliliter/kilogram (mL/kg) of 0.2% ropivacaine with 5 mcg/mL (1:200,000) epinephrine. Fentanyl may be used as needed for additional analgesia and anesthesia will be maintained with sevoflurane. The skin will not be infiltrated with additional local anesthetic at the conclusion of the case.
15931437|NCT03408340|Drug|Standard of Care Anesthesia|Participants in this arm will be induced for anesthesia with propofol 3mg/kg or ketamine 2mg/kg (if there is intravenous access) or sevoflurane with 1 mcg/kg of fentanyl and 1.2 mg/kg rocuronium once IV access is established. The patient will be intubated; intravenous and intra-arterial access will be obtained and the patient will be positioned for surgery. Fentanyl may be used as needed for additional analgesia and anesthesia will be maintained with sevoflurane. The skin will be infiltrated at the conclusion of surgery with less than 1 mL/kg of 0.25% bupivacaine with epinephrine 1:200,000.
15931438|NCT03408327|Device|Wearable technology|Fitness wristband & APP
15931439|NCT03408327|Behavioral|LINE group|Promote social interaction
15931440|NCT03408327|Behavioral|Group activities|Which was developed by applying social cognitive theory
15931441|NCT03408327|Device|Health promotion manual|Which was about general physical activity promotion content
15931499|NCT03407859|Biological|Sequential Treatment With different CART|Sequential Treatment With CD20/CD22/CD10-CART After CD19-CART Treatment in Relapsed/Refractory B-ALL
15931442|NCT03408314|Other|PediQUEST Response|PediQUEST Response consists of regular feedback of electronic patient reported outcomes (child symptoms and quality of life) to providers and families coupled with involvement of the palliative care team, who will meet with families and providers within three weeks of randomization and follow-up at least monthly as deemed necessary based on PediQUEST feedback reports and other clinical indications.
15931443|NCT03408314|Other|Usual Cancer Care|Patients assigned to the usual cancer care arm, will receive the standard care provided by participating sites + be required to complete PediQUEST surveys (but no reports will be generated).
15931444|NCT03408301|Procedure|Tourniquet deflation|Tourniquet deflation
15931445|NCT03408288|Other|Hemapoche|Use of Hemapoche scale to assess hematuria in reference samples
15931446|NCT03408288|Other|Hemastick|Use of Hemastick scale to assess hematuria in reference samples
15931447|NCT03408288|Other|Color description|Describe color of reference sample
15931448|NCT03408275|Other|None - observational|None - observational
15931449|NCT03408262|Biological|Ad4-EnvCN54|Live, replication-competent adenovirus 4 vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
15931450|NCT03408262|Biological|MVA-CN54|Live, non-replicating modified vaccinia Ankara vector, engineered to express the envelope glycoprotein of HIV-1 isolate 97CN54
15931451|NCT03408262|Biological|CN54gp140/MPLA|Recombinant glycoprotein of HIV-1 isolate 97CN54, with liposomal monophosphoryl lipid A adjuvant
15931452|NCT03408249|Diagnostic Test|IBDoc calprotectin test|Patients are asked to perform a single IBDoc calprotectin home test.
15931453|NCT03408249|Other|questionnaire|Patients evaluate the ease-of-use of the test, clearness of test results and comprehensiveness of the instructions for use through a specific questionnaire implementing Likert scales.
15931454|NCT03408236|Drug|Botulinum toxin type A|Experimental
15931455|NCT03408236|Drug|Botulinum toxin type A|Active Comparator
15931456|NCT03408223|Radiation|total body irradiation|"Drug: Cyclophosphamide 60 mg/kg/day intravenous x 2 days pre-transplant, total dose 120 mg/kg
~Drug: Cyclosporine or tacrolimus Beginning on Day -1 pre-transplant maintaining a level of 150-250 ng/ml or 5-10 ng/ml respectively. Cyclosporine or tacrolimus dosing will be monitored and altered as clinically appropriate by physician, and discontinue at approximately day + 180 post-transplant.
~Drug: Methotrexate 15 mg/m2 intravenous on days 1, 10 mg/m2 intravenous on days 3, 6 and 11 after transplantation.
~Intervention: Total Body Irradiation Dose of 10 Gy TBI (fraction size of 5 Gy given once a day on days -2 and -1).
~Procedure: Peripheral blood stem cell transplantation product will be infused via intravenous drip on Day 0."
15931457|NCT03408223|Radiation|total marrow and lymphoid irradiation|"Drug: Cyclophosphamide 60 mg/kg/day intravenous x 2 days pre-transplant, total dose 120 mg/kg
~Drug: Cyclosporine or tacrolimus Beginning on Day -1 pre-transplant maintaining a level of 150-250 ng/ml or 5-10 ng/ml respectively. Cyclosporine or tacrolimus dosing will be monitored and altered as clinically appropriate by physician, and discontinue at approximately day + 180 post-transplant.
~Drug: Methotrexate 15 mg/m2 intravenous on days 1, 10 mg/m2 intravenous on days 3, 6 and 11 after transplantation.
~Intervention: Total Marrow and Lymphoid Irradiation Dose of 12-20 Gy TMLI (fraction size of 4 Gy given once a day).
~Procedure: Peripheral blood stem cell transplantation product will be infused via intravenous drip on Day 0."
15931458|NCT03408210|Radiation|total body irradiation|"Drug: Cyclophosphamide 60 mg/kg/day intravenous x 2 days pre-transplant, total dose 120 mg/kg
~Drug: Cyclosporine or tacrolimus Beginning on Day -1 pre-transplant maintaining a level of 150-250 ng/ml or 5-10 ng/ml respectively. Cyclosporine or tacrolimus dosing will be monitored and altered as clinically appropriate by physician, and discontinue at approximately day + 180 post-transplant.
~Drug: Methotrexate 15 mg/m2 intravenous on days 1, 10 mg/m2 intravenous on days 3, 6 and 11 after transplantation.
~Intervention: Total Body Irradiation Dose of 10 Gy TBI (fraction size of 5 Gy given once a day on days -2 and -1).
~Procedure: Peripheral blood stem cell transplantation product will be infused via intravenous drip on Day 0."
15931459|NCT03408210|Radiation|total marrow and lymphoid irradiation|"Drug: Cyclophosphamide 60 mg/kg/day intravenous x 2 days pre-transplant, total dose 120 mg/kg
~Drug: Cyclosporine or tacrolimus Beginning on Day -1 pre-transplant maintaining a level of 150-250 ng/ml or 5-10 ng/ml respectively. Cyclosporine or tacrolimus dosing will be monitored and altered as clinically appropriate by physician, and discontinue at approximately day + 180 post-transplant.
~Drug: Methotrexate 15 mg/m2 intravenous on days 1, 10 mg/m2 intravenous on days 3, 6 and 11 after transplantation.
~Intervention: Total Marrow and Lymphoid Irradiation Dose of 12 Gy TMLI (fraction size of 4 Gy given once a day on days -6, -5 and -4).
~Procedure: Peripheral blood stem cell transplantation product will be infused via intravenous drip on Day 0."
15931460|NCT03408197|Device|EasyWarm|Perioperative warming with EasyWarm to prevent inadvertent hypothermia during anaesthesia
15931461|NCT03408197|Device|BairHugger|Perioperative warming with BairHugger to prevent inadvertent hypothermia during anaesthesia
15931462|NCT03408184|Drug|Lumbar paravertebral group|A mixture of 0.5 ml /kg bupivacaine (0.25%), and 0.5µg/Kg dexmedetomidine and Epinephrine 5 microgram/ ml.
15931463|NCT03408184|Drug|The field block group|A mixture of 0.5 ml /kg bupivacaine (0.25%), and 0.5µg/Kg dexmedetomidine and Epinephrine 5 microgram/ ml.
15931464|NCT03408171|Device|19-gauge FNA needle|A 19-gauge FNA needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNB needle.
15931465|NCT03408171|Device|19-gauge FNB needle|A 19-gauge FNB needle will be used to obtain liver tissue during an endoscopic-ultrasound guided liver biopsy. Tissue yield and diagnostic accuracy will be assessed and compared to that of the 19-gauge FNA needle.
15931466|NCT03408158|Procedure|same type infusion of main HPA antigen|Compare the differences of platelet count between participants with same type infusion of main HPA antigen and not
15931467|NCT03408145|Device|Hyaluronic Acid|Injection of 3x 2.5ml of Hyaluronic Acid
15931468|NCT03408145|Device|Amniotic Tissue Allograft|Injection of 1x 1ml of Amniotic Tissue Allograft
15931469|NCT03408145|Drug|Saline|Injection of Saline
15931470|NCT03408132|Drug|FE203799|FE203799 5 mg subcutaneous once weekly
15931471|NCT03408119|Dietary Supplement|Dried Plum|Dried plum fruit, 100g or 50g depending on treatment group randomized to
15931472|NCT03408119|Dietary Supplement|800 IU vitamin D and 450mg elemental calcium|Supplemental vitamin D and calcium to protect against further bone loss
15931473|NCT03408093|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b (INFb-1b) was used at the standard dose of 250 mg/ml.
15931474|NCT03408080|Drug|BHV-4157|BHV-4157 is a glutamate modulating drug that is being developed for eventual commercial use in the treatment of spinocerebellar ataxia (SCA). This is currently no approved medication indicated for SCA.
15931475|NCT03408054|Drug|Oxytocin|Oxytocin 10-5M solution
15931476|NCT03408054|Drug|Nitroglycerin|Nitroglycerin 25-1000mcg
15931477|NCT03408041|Other|Medical file data extraction|Medical file data extraction
15931478|NCT03408028|Other|Medical File consultation|Medical File consultation
15931479|NCT03408015|Drug|Lifitegrast|Lifitegrast ophthalmic solution, 5.0%. 1 drop instilled into each eye once in the morning and once before bed.
15931480|NCT03408002|Behavioral|Psychological intervention|"The intervention aims to increase self-efficacy perception in managing pre-operative anxiety. The intervention is based on one single psychological consultation adopting the Four elements technique elaborated by Shapiro"
15931481|NCT03407976|Drug|Apatinib|Apatinib oral daily at starting dose 1, Dose Level 2 or Dose Level 3 in phase I, and then whichever is the maximum tolerated dosage will be used for all Phase II patients.
15931482|NCT03407976|Drug|Pembrolizumab|200 mg Q3 weeks IV
15931483|NCT03407963|Procedure|Embolization|Embolization by microparticles (300-500 microns)
15931484|NCT03407950|Behavioral|IPT+|Integrated Psychological Treatment and cognitive remediation and relaxation and Mindfulness : IPT+. A blind evaluation will be realized thanks to questionnaires of the current practice to compare the IPT+ versus treatment as usual (TAU).
15931485|NCT03407950|Behavioral|Treatment as usual|no specific therapy but same number and duration of each sessions than IPT+. A blind evaluation will be realized thanks to questionnaires of the current practice to compare the IPT+ versus treatment as usual (TAU).
15931486|NCT03407937|Behavioral|Hypnosis|Hypnosis is a therapeutic method in which the experimenter or therapist make suggestions to individuals after they have undergone a hypnotic induction. This induction is a relaxation procedure designed to focus one's mind and to induce a hypnotic trance in individuals. The hypnotic trance consists in a state of deep absorption, concentration and altered sensations, cognitions and behaviors. Hypnosis can be used for pain control in experimental and clinical settings. In this study, standardized hypnosis including a relaxation technique for the hypnotic induction and a direct hypnotic analgesia technique for the hypnotic suggestions will be used.
15931487|NCT03407937|Behavioral|Meditation|Meditation is a relaxation method that can be used to reduce pain symptoms and pain perception in clinical and experimental situations. In this study, a standardized mindfulness meditation session of 20 minutes will be used to induce a relaxation and an analgesic effect in participants. Mindfulness meditation is a practice intended to increase mindfulness and awareness of the self and the environment by techniques of controlled breathing, focus on neutral elements, and observation of one's thoughts and emotions without judgment.
15931488|NCT03407937|Other|Conditioned pain modulation|Conditioned pain modulation (CPM) is a pain inhibition mechanism that is used to assess endogenous analgesia capacity. The method to evaluate CPM in healthy individuals and patients with pain includes both a conditioning stimulus (a noxious stimulus that induces CPM) and a test stimulus (a noxious stimulus used to evaluate the analgesic response to the conditioning stimulus). In this study, the conditioning stimulus will be a cold pressor test (two-minutes immersion of one hand in ice water) and the test stimulus will be a two-minutes thermal noxious stimulus delivered by a contact thermode.
15931489|NCT03407937|Drug|Placebo Oral Tablet|A placebo is a substance (or treatment) with no active therapeutic effect. The placebo effect (analgesia) in this study will be induced by the oral administration of one inert tablet (sugar pill). The tablet is a round, hard, white, flat-faced tablet with no active ingredient. The participant is told that the tablet is an active drug, more specifically an analgesic or a painkiller, that is used to achieve analgesia, relief from pain. This placebo condition is used to induce a diffuse analgesic effect in participants.
15931490|NCT03407924|Other|Aerobic Exercise (AER)|Aerobic exercise will be performed with a treadmill or stationary tandem bike 3 times per week. Each exercise session will take about 30 minutes plus 5 to 10 min of warm-up and cool-down. Participants will wear a safety harness.
15931491|NCT03407924|Other|Rehabilitation|Rehabilitative program is focused on completion of activities of daily living, initiation, appropriate behavior and community integration for five days per week at the Centre for Neuro Skills.
15931492|NCT03407911|Other|Harvested|Metagenomic exam of Gingival crevicular fluid harvested by adsorbent paper point around periodontal teeth and implant affected by peri-implantitis
15931493|NCT03407898|Other|intubation time|intubation attempt number and intubation time
15931494|NCT03407885|Other|Bundled payments for knee and hip replacement|"The bundled payment model holds acute care hospitals (ACHs) financially responsible for the spending and quality of an entire episode of care for two types of hospital admissions: MS-DRG 469 and 470. An episode begins with an ACH stay that results in a discharge in one of the two DRGs, and ends 90 days after discharge. Before each performance year begins, hospitals receive target prices from CMS, determined by historical hospital and regional episode expenditures. Hospitals are eligible for reconciliation payment from CMS if they spend less than the target prices for an episode, provided that they met an acceptable quality standard. Conversely, they are responsible for paying the difference if they spend more than the target prices."
15931495|NCT03407872|Drug|Esketamine DPI|Participants will receive different number of consecutive Esketamine DPI inhalations, consider as a single dose. There will be dose escalation between cohorts.
15931496|NCT03407872|Drug|Esketamine DPI|"Participants will receive different dosing sequences of Esketamine DPI inhalations, consider as a single dose. There will be dose escalation between cohorts. Number of Esketamine DPI inhalations within a dosing sequence will be defined based on results from PART A of the study.
~Dose: very low, low, medium, high."
15931497|NCT03407872|Drug|Esketamine DPI|"Participants will receive different cycle of treatment consisting of 4 dosing sequences administered within 2 weeks. There will be dose escalation between cohorts. Participants in this part will be randomized to receive Esketamine DPI or placebo in 3:1 ratio. Number of Esketamine DPI inhalations within a dosing sequence will be defined based on results from PART A and PART B of the study.
~Dose: very low, low, medium, high."
15931498|NCT03407872|Drug|Placebo DPI|"Participants will receive different cycle of treatment consisting of 4 dosing sequences administered within 2 weeks. Participants in this part will be randomized to receive Esketamine DPI or placebo in 3:1 ratio.
~In each cohort, number of placebo inhalations within a dosing sequence will correspond to number of Esketamine DPI inhalations."
15931501|NCT03407833|Other|Endoscopy biopsy|Tissue samples will be collected from the jejunum, duodenum, and colon during the subject's standard of care procedure.
15931502|NCT03407833|Other|Surgical biopsy|Biopsy of the liver is standard of care for diagnosing NAFLD. Biopsy of omentum, skeletal muscle and subcutaneous adipose (the latter two tissues taken at the site of trocar placement) will be collected intraoperatively at the time of Roux-en-Y gastric bypass (RYGB) or vertical sleeve gastrectomy (VSG).
15931503|NCT03407833|Other|Mixed-meal tolerance test|The mixed meal tolerance test (MMTT) shows how much insulin your body is making after drinking a liquid meal beverage that contains fats, protein and carbohydrates (sugar). Glucose, C-peptide, free fatty acids, triglycerides, incretins, pancreatic polypertide, bile aceis, and fatty acid amides can also be measured. A total of 9 tablespoons of blood is taken over a 255 minute period.
15931504|NCT03407833|Other|Excised Liver Tissue Sampling|Tissue will be collected from the excised liver for research after the diseased liver has been removed as part of the standard of care procedure.
15931505|NCT03407820|Procedure|Absorbable Chromic gut sutures|In this group interrupted simple or horizontal mattress skin sutures are used for wound closure per surgeon preference. Standardized wound care instructions will be given to all patients. Those who received absorbable Chromic sutures are treated recording to the standard protocol and they are advised that they can start to gently rub the scab and suture line to encourage the sutures to fall off starting 10-14 days postoperatively.
15931506|NCT03407820|Procedure|Non-absorbable Nylon sutures|In this group interrupted simple or horizontal mattress skin sutures are used for wound closure per surgeon preference. Standardized wound care instructions will be given to all patients. Those who received Nylon sutures are treated recording to the standard protocol and sutures are removed after the usual time (10-14 days) of the received procedure.
15931507|NCT03407794|Other|Fermented vegetable|The intervention is to consume 1/2 cup fermented vegetables every day for 6 weeks
15931508|NCT03407794|Other|Non-fermented vegetable|The intervention is to consume 1/2 cup of non-fermented vegetables every day for 6 weeks
15931509|NCT03407781|Drug|68Ga-BBN-IRDye800CW|PET/NIR fluorescent imaging-guided surgery
15931510|NCT03407768|Behavioral|Individualized interventions|"A participant will be able to select one or more (or no intervention) based on her preferences.
~Individualized exercise program Yoga and mindfulness Massage therapy Acupuncture Others: Women who are not interested in any above intervention but like to explore other interventions will be offered material pertinent to their choice of complimentary techniques."
15931511|NCT03407755|Procedure|Intraocular gas|Participants randomized to either air or SF6 gas in the anterior chamber.
15931512|NCT03407742|Behavioral|CAPAS Youth|9-week parenting intervention
15931513|NCT03407729|Other|Magnetic Resonance Imaging|MRI uses a strong magnetic field and radio waves to create detailed images of the brain while the person's head is positioned inside a round tunnel.
15931514|NCT03407729|Other|Electroencephalography|EEG tracks and records brain wave patterns. A head cap with small discs and thin wires (electrodes) is placed on the scalp, and then send signals to a computer.
15931515|NCT03407729|Other|Cognitive Performance Testing|"For the Verbal n-back: During the fMRI scan, children will respond to a letter displayed on a small screen and indicate (by pushing a button) whether the letter shown is the same as a previously displayed letter. Children will repeat this test during the EEG.
~For the Grooved Pegboard task: After the MRI scan, children will be timed as they place pegs into holes with randomly positioned slots."
15931516|NCT03407716|Drug|American Ginseng|Given PO
15931517|NCT03407716|Other|Laboratory Biomarker Analysis|Correlative studies
15931518|NCT03407716|Other|Placebo|Given PO
15931519|NCT03407716|Other|Questionnaire Administration|Correlative studies
15931520|NCT03407703|Drug|Elbasvir / Grazoprevir Oral Tablet [Zepatier]|HCV treatment
15931521|NCT03407690|Other|nasal swab|collection of nasal swab to allow carriage of pneumococci to be assessed
15931522|NCT03407677|Device|ROTO track®|An electronic injection form and injection log for keeping track of injection sites in the abdominal region. The device attaches directly to the insulin pen and activates whenever the insulin pen is picked up.
15931523|NCT03407664|Other|this field is not applicable|We will not be testing an intervention. Only the long term outcomes of men screened for AAA in England.
15931524|NCT03407651|Biological|Coagulation Factor VIIa variant|Single intravenous injection of MarzAA, followed by single subcutaneous injection of MarzAA, followed by daily subcutaneous injection of MarzAA for 50 days at final dose level required.
15931525|NCT03407638|Other|PROUD Intervention|The PROUD intervention includes 3 strategies used to implement the MA Model: 1. Clinic leadership receives funding for a 1.0 full time equivalent NCM for 2 years after randomization and technical support for recruiting and hiring the NCM. Once hired for the study, the NCM will receive technical assistance (TA) from experts at Boston Medical Center (BMC) supported by PROUD, but NCMs will be employed and supervised by the health system. 2. Experts at BMC who originally developed and disseminated the MA Model will: provide intervention clinics with a Manual; train PROUD NCMs at BMC; and provide the ongoing TA for 2 years after randomization. 3. At least 3 primary care providers in the PROUD intervention clinic will obtain DEA waivers to prescribe buprenorphine for OUDs, if not already waivered, and work closely with the NCM to offer high quality primary care for OUDs (e.g. medication treatment with buprenorphine or naltrexone with close follow-up to maximize retention in treatment).
15931526|NCT03407625|Other|Foley bulb plus Oral Misoprostol|"Although labeled experimental for comparison purposes, this is not an experimental intervention, as the method is a currently accepted standard of care for cervical ripening and labor induction in the United States."
15931527|NCT03407625|Other|Oral Misoprostol|Patients will receive standard oral misoprostol 100mcg according to current Labor Induction Protocol.
15931528|NCT03407612|Device|Continuous Passive Motion|CPM devices are used in postoperative rehabilitation and are throughout to reduce joint stiffness.
15931529|NCT03407599|Drug|Faster aspart|An injection of fast-acting insulin aspart 0.2 U/kg body weight under the skin just prior to a standard meal.
15931530|NCT03407599|Drug|Insulin aspart (NovoRapid®)|An injection of insulin aspart (NovoRapid®) 0.2 U/kg body weight under the skin just prior to a standard meal.
15931531|NCT03407586|Diagnostic Test|Point-of-care STI testing|All participants underwent point-of-care STI testing (GeneXpert), and if diagnosed with a STI were offered immediate therapy, and expedited therapy, if indicated.
15931532|NCT03407573|Biological|Administration of Red Cell|Transfusion of red cells dependent on haemoglobin level. Either transfused at haemoglobin of 7 or 9.
15931533|NCT03407560|Device|SintLife|"Patients will be treated for degenerative diseases of the spine, such as lumbar stenosis, spondylolysis and spondylolisthesis, degenerative disc disease.
~The fusion technique used will be the posterolateral arthrodesis of one or more vertebral levels included in the lumbosacral region (L1-S1), obtained by screws and bars, together with a preparation of the transverse processes treated with bone substitute in order to Sintlife obtain new bone formation and then spinal fusion. It is also possible to associate interbody fusion with the use of a cage."
15931534|NCT03407547|Diagnostic Test|Electroencephalography|EEG is a device to measure brain activity via surface electrodes
15931535|NCT03407521|Drug|Misoprostol|induction of abortion using misoprostol
15931536|NCT03407521|Drug|isosorbide mononitrate|isosorbide mononitrate
15931537|NCT03407521|Drug|Placebo|Placebo
15931538|NCT03407508|Dietary Supplement|Comparison of Diets|Okinawan-based Nordic Diet and Control Diet
15931540|NCT03407482|Drug|GDC-0853|Participants received GDC-0853 at a dose of 200mg, as per the dosing schedule described above.
15931541|NCT03407469|Behavioral|Questionnaires|Questionnaires completed at the time participant joins this study and then about 30 days, 3 months, 6 months, and 12 months after that. Questionnaires will be about quality of life and experiences with treatment for venous thromboembolism (VTE). It should take less than 10 minutes to complete the questionnaires each time.
15931542|NCT03407456|Other|Gastroesophageal reflux symptoms questionnaire|Reflux Symptom Questionnaire, 7-day recall (RESQ-7).
15931543|NCT03407443|Other|Exposure to Make the Connection messages|Participants are exposed to Make the Connection messages (each approximately 3 minutes in length) weekly for over a four-month study period through the study mobile application.
15931544|NCT03407443|Other|Active Control Group|Participants are exposed to VA news clips/segments (each approximately 3 minutes in length) weekly for over a four-month study period through the study mobile application.
15931545|NCT03407430|Drug|Pregabalin|During the first chemotherapy cycle, the patient will receive pregabalin 75mg (1 capsule) BID x 4 days before pegfilgrastim 6mg subcutaneous (SC) x1; then pregabalin 150mg (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive placebo in the same dosing scheme.
15931546|NCT03407430|Drug|Placebo|During the first chemotherapy cycle, the patient will receive placebo (1 capsule) BID x 4 days before pegfilgrastim 6mg SC x1; then placebo (2 capsules) BID x 7 days. During the second chemotherapy cycle, the patient will receive pregabalin in the same dosing scheme.
15931547|NCT03407417|Other|virtual technology - highly tailored|The app will first ask participants a short series of questions designed to assess their baseline risk for colon cancer. Highly tailored patient reminders will be customized using all 12 constructs.
15931548|NCT03407417|Other|virtual technology - tailored minimally|The app will first ask participants a short series of questions designed to assess their baseline risk for colon cancer. Minimally tailored patient reminders will be customized using 4 randomly selected constructs.
15931549|NCT03407404|Combination Product|Ketamine-Midazolam|Continous intravenous sedation with 36mg of Midazolam and 900mg of Ketamine mixed in 50ml syringes as long as patient still requires sedation.
15931550|NCT03407404|Combination Product|Morphine -Midazolam|Continous intravenous sedation with 54mg of Morphine Sulphate and 36mg of midazolam mixed in 50ml syringes as long as participant still requires sedation.
15931551|NCT03407391|Other|None - observational|No intervention - observational only
15931552|NCT03407378|Drug|IPT803|Administration of IPT803 three times a day for 12 weeks as add-on therapy to patient regular PD medication(s) or as a new therapy for drug naïve patients.
15931553|NCT03407378|Genetic|Optional pharmacogenetic assessment|Blood sample of 3 milliliters for genotyping assessment (according to patient consent).
15931554|NCT03407378|Other|Questionnaires|Personality, Health and Disease questionnaires completion during the study (Visits 1, 2, 3 and 4)
15931555|NCT03407378|Other|Optional Blood-Oxygen-level Dependent functionalMRI|BOLD fMRI performed in a sub-group of patients, depending of randomization (exploratory)
15931556|NCT03407378|Other|Motor Assessments before taking regular PD treatment|Regular PD treatment stopped 12 or 24 hours prior to Visits 2, 3 and 4 depending on the drug form (extended vs standard release). Motor assessments using UPDRS Part III are performed when patients are OFF regular PD treatment. Regular PD treatment is taken on site during the visit after the motor assessments are performed.
15931557|NCT03407378|Other|Motor Assessments on regular PD treatment|Regular PD treatment is not modified before the visits. The motor assessments using UPDRS Part III are performed while the patient is on regular PD treatment.
15931558|NCT03407365|Behavioral|10 Week Exercise Program|Subjects will complete a 10 week exercise program using DVD with instructions provided. Participants will have to do one session of exercise on 5 different days each week for a total of 5 sessions per week, for 10 weeks.
15931559|NCT03407365|Behavioral|DVD Program After 10 Weeks|If the DVD program shows to help participants in Group 1, the program and DVD will be provided to Group 2 participants
15931560|NCT03407352|Behavioral|Active Video Game Play|60 minutes of active video game play at a moderate intensity
15931561|NCT03407352|Behavioral|Passive Video Game Play|60 minutes of passive video game play
15931562|NCT03407339|Other|Shared Oral Care intervention|"One hour of teaching in oral hygiene and oral diseases to health care professionals at the intervention nursing homes.
~The dentists will make an assessment of the elderly's oral hygiene at baseline, after three and six months using a mucosal and plaque score. During the six months, a dentist will be doing ward rounds at each nursing home in a specific time interval. In dialog with the resident and the healthcare professional, the dentist will present individual advice on how to perform oral care based on the resident's oral care routines, oral hygiene status, and the resident's physical and cognitive function level."
15931563|NCT03407326|Dietary Supplement|Alternative RUTF|The alternative RUTF contains oat, peanuts, sugar, milk powder, vegetable oil as well as premix containing concentrated minerals and vitamins and emulsifier.
15931564|NCT03407326|Dietary Supplement|Standard RUTF|Standard RUTF contains peanut paste, sugar, non-fat dried milk (NFDM), vegetable oil, a premix containing concentrated minerals and vitamins, and emulsifier.
15965521|NCT03146416|Drug|Placebo|Matching placebo
15931565|NCT03407313|Device|Rotational fractional resection (1.5mm diameter device)|Single treatment of skin resection and focal lipectomy (removal of loose skin and fat)
15931566|NCT03407300|Drug|Docetaxel|To evaluate the safety and efficacy of Docetaxel alone in stage III-IV NSCLC patients
15931567|NCT03407300|Drug|Chinese traditional medicine XH1|To evaluate the safety and efficacy of Docetaxel combined with Chinese tradition medicine XH1 in stage III-IV NSCLC patients
15931568|NCT03407287|Procedure|Peripheral Intravenous Analysis (PIVA)|Non-invasive measurement of peripheral venous waveform analysis (PIVA) obtained by connecting a standard transducer (AD Instruments, Colorado Springs, Co) to a universal adaptor or stopcock on a peripheral IV
15931569|NCT03407287|Procedure|Standard of care invasive vascular monitoring|Standard of care invasive monitoring in the intensive care settings with central venous catheters, pulmonary artery catheters, or trans-esophageal echocardiography for determining volume status.
15931570|NCT03407287|Procedure|Standard noninvasive vascular monitoring|Standard noninvasive vascular monitoring of blood pressure, pulse rate, pulse oximetry and respiratory rate.
15931571|NCT03407261|Procedure|micro-osteoperforations|Three vertical micro-osteoperforations, using Excellerator, in the buccal extracted site were executed following the aseptic procedure and local anesthesia
15931572|NCT03407235|Device|Computerized Laparoscopic Trainer|Gold standard laparoscopic trainer using simulated computerized equipment.
15931573|NCT03407235|Device|Box trainer with eye patch|Simple, cost effective box trainer, with loss of dept perception achieved with use of eye patch
15931574|NCT03407222|Other|Text messages|Text messages which encourage the increment of daily step count
15931575|NCT03407209|Other|consumption of local anesthetic measurement|consumption of local anesthetic measurement in both groups
15931576|NCT03407196|Drug|Forxiga|Oral antidiabetics
15931577|NCT03407183|Procedure|intradetrusor injection of botulinumtoxinA (Botox)|intradetrusor injection of botulinumtoxinA (Botox®, Allergan, Irvine, USA) to assess the efficacy of Botox in treatment of neurogenic bladder.
15931578|NCT03407170|Biological|pembrolizumab|200 mg by IV infusion Q3W for up to 24 months
15931579|NCT03407157|Dietary Supplement|Probiotic supplementation|Participants will take two capsules daily of Urex Plus VCap-5 (each containing 2.5 billion CFUs of L. rhamnosus and L. reuteri) and one lozenge of Blis K12 (1 billion CFUs of streptococcus Salivarius)
15931580|NCT03407157|Other|Placebo|Participants will be asked to take 2 placebo capsules and 1 placebo lozenge daily from 25 weeks pregnancy
15931591|NCT03407131|Procedure|Joint replacement surgery|Joint replacement surgery is to replace the original joint function, so that the patient can recover the joint function as soon as possible.
15931592|NCT03407131|Procedure|Intramedullary nail fixation|Internal fixation surgery is the stable fixation of fracture, which provides the condition for the restoration of joint function.
15931593|NCT03407118|Drug|LY900014|Administered SC.
15931594|NCT03407118|Drug|Insulin Lispro|Administered SC.
15931595|NCT03407105|Biological|MDX-010|Specified dose on specified days
15931596|NCT03407092|Other|ADAPT cohort|Thrombectomy with distal aspiration technique
15931597|NCT03407092|Other|Stentriever Cohort|Thrombectomy with stent retriever
15931598|NCT03407079|Other|Sucralose|Sucralose is an organochlorine and is approximately 600 times sweeter than sucrose. Participants will receive sucralose (approximately 4mg/kg/day) or placebo by mouth in a capsule for 28 days. This dose corresponds to the amount of sucralose contained in approximately 3 or 4 twelve ounce cans of commercially-available diet soda for a 70 kg adult.
15931599|NCT03407079|Other|Placebo|Placebo capsule will be taken orally for 28 days
15931600|NCT03407053|Dietary Supplement|Ultra-processed diet|Consuming ultra-processed diet over a 2-week period
15931601|NCT03407053|Dietary Supplement|Unprocessed diet|Consuming unprocessed diet over a 2-week period
15931602|NCT03407027|Drug|Quadratus triamcinolone|40mg of triamcinolone and 10ml of levobupivacaine 0,25%.
15931603|NCT03407027|Drug|Gluteus triamcinolone|40mg of triamcinolone and 10ml of levobupivacaine 0,25%.
15931604|NCT03407027|Drug|quadratus without triamcinolone.|10ml of levobupivacaine 0,25%.
15931605|NCT03407001|Procedure|Contrast-Enhanced Ultrasound|Undergo CEUS
15931606|NCT03407001|Drug|Sulfur Hexafluoride Lipid Microspheres|Given IV
15931607|NCT03407001|Procedure|Ultrasound|Undergo non-contrast US
15932459|NCT03400436|Other|No intervention in observational studies|No intervention in observational studies
15931608|NCT03406988|Procedure|Autologous fat grafting|Implantation of small amount of autologous adipose tissue at the base of the finger to induce a rapid healing of the distally located DU
15931609|NCT03406988|Procedure|Sham procedure|Local injection of 0.5ml saline solution after a simulated liposuction procedure.
15931610|NCT03406975|Device|Overstitch|Endoscopic sleeve gastroplasty
15931612|NCT03406949|Biological|MGD009|B7-H3 x CD3 DART protein
15931613|NCT03406949|Biological|MGA012|anti-PD-1 antibody
15931614|NCT03406936|Drug|Daily interruption of midazolam|daily at 7 am midazolam infusion will be stopped spontaneous breath trial will be done
15931615|NCT03406923|Other|Health literacy-psychosocial support|The intervention is based upon enhancing patient health literacy-related attributes by (1) addressing the barriers to patients' self-efficacy by working with the patient to minimize the barriers (2) clarifying the patient beliefs about diabetes and diabetes medications, and (3) developing personalized action plans. We will tailor the intervention to each patient, so, the details of the content of each session will depend on the individual's self-efficacy, beliefs in illness and medicines, and health literacy level obtained at baseline. In addition to the 45-minute scheduled sessions, patients will be able to call the clinical pharmacist on the phone during the 6-week session at their discretion, for patient-driven support for self-management of goals and skills.
15931616|NCT03406897|Drug|Cholecalciferol|Oral Administration
15931617|NCT03406897|Drug|Omega 3 fatty acid|Oral Administration
15931618|NCT03406884|Biological|c-kit+ cells|The autologous c-kit+ cells will be harvested from participant's right atrial tissue obtained from participant's SOC Norwood Operation. The harvested c-kit+ cells containing up to a total of 12,500 cells/kg will be delivered through 6-10 intramyocardial injections of approximately 100uL per injection for a total volume of approximately 0.6 mL.
15931619|NCT03406871|Drug|Regorafenib|One course will last 28 days. Oral administration at a dose of 80 mg/day, 120mg/day or 160 mg/day for 21 consecutive days, with a 1-week washout period.
15931620|NCT03406871|Drug|Nivolumab|One course will last 28 days. Given once every 2 weeks at a dose of 3.0 mg/kg.
15931621|NCT03406858|Biological|HER2Bi-Armed Activated T Cells|Given IV
15931622|NCT03406858|Other|Laboratory Biomarker Analysis|Correlative studies
15931623|NCT03406858|Biological|Pembrolizumab|Given IV
15931624|NCT03406845|Behavioral|Chair-side mindfulness intervention|"Tailored mindfulness intervention to chair-side type, based from Mindfulness Based Cognitive Therapy (MBCT).
~Health promotion based on the Health Enhancement Program (HEP)."
15931625|NCT03406832|Drug|Nitroprusside Sodium|Intracoronary infusion 50~100μg each time (repeated)
15931626|NCT03406832|Drug|Tirofiban Hydrochloride|Intracoronary infusion 10μg/kg for single time
15931627|NCT03406832|Drug|Heparinized saline|Intracoronary infusion 2ml for single time
15931628|NCT03406819|Drug|Nitroprusside Sodium|Intracoronary infusion 50~100μg each time (repeated)
15931629|NCT03406819|Drug|Tirofiban Hydrochloride|Intracoronary infusion 10μg/kg for single time
15931630|NCT03406819|Drug|Heparinized saline|Intracoronary infusion 2ml for single time
15931631|NCT03406806|Other|Gaitbox|"The walking path will be set according to the directions of the NIH toolbox 4 meter clinic walk test which includes marking the beginning and end of the walking path. A standard manual stopwatch will be used to record time. The examiner will demonstrate the task then instruct the participant to Walk at a comfortable pace and count down by saying: 3, 2, 1, go. The stop watch will be used to time the amount of time it takes to walk between the cones. Subjects will complete 3 timed trials. The time will be recorded in the log. Simultaneously, the Sprint System [6] will be operated according to manufacturers instructions. The Gaitbox will be set up at the end of the 4 meter walking path at a height of 4 feet from the floor. Times/speeds will be recorded on log sheet."
15931632|NCT03406806|Other|SprintSystem device|"The walking path will be set according to the directions of the NIH toolbox 4 meter clinic walk test which includes marking the beginning and end of the walking path. A standard manual stopwatch will be used to record time. The examiner will demonstrate the task then instruct the participant to Walk at a comfortable pace and count down by saying: 3, 2, 1, go. The stop watch will be used to time the amount of time it takes to walk between the cones. Subjects will complete 3 timed trials. The time will be recorded in the log. Simultaneously, the Sprint System [6] will be operated according to manufacturers instructions. The Gaitbox will be set up at the end of the 4 meter walking path at a height of 4 feet from the floor. Times/speeds will be recorded on log sheet."
15931633|NCT03406806|Other|NIH toolbox 4 meter walk|"The walking path will be set according to the directions of the NIH toolbox 4 meter clinic walk test which includes marking the beginning and end of the walking path. A standard manual stopwatch will be used to record time. The examiner will demonstrate the task then instruct the participant to Walk at a comfortable pace and count down by saying: 3, 2, 1, go. The stop watch will be used to time the amount of time it takes to walk between the cones. Subjects will complete 3 timed trials. The time will be recorded in the log. Simultaneously, the Sprint System [6] will be operated according to manufacturers instructions. The Gaitbox will be set up at the end of the 4 meter walking path at a height of 4 feet from the floor. Times/speeds will be recorded on log sheet."
15931634|NCT03406793|Dietary Supplement|Standard MNP|Standard MNP, 15 micronutrients (Vitamin A 400 µg, vitamin D 5 µg, vitamin E 5 mg, vitamin C 30 mg, thiamine 0.5 mg, riboflavin 0.5 mg, niacin 6 mg, pyridoxine 0.5 mg, vitamin B12 0.9 mg, folate 150 µg, iron 10 mg, zinc 4.1 mg, copper 0.56 mg, selenium 17.0 µg and iodine 90 µg). Daily supplementation for 24 weeks.
15931635|NCT03406793|Dietary Supplement|High zinc, low iron MNP|Same as group 1, except with 10 mg zinc instead of 4.1 mg and 6 mg iron instead of 10 mg. Daily supplementation for 24 weeks.
15931636|NCT03406793|Dietary Supplement|High zinc, low/no iron on alternating days|Same as study group 1, except with 10 mg zinc instead of 4.1 mg, and 6 mg iron and no iron on alternating days instead of 10 mg. Daily supplementation for 24 weeks.
15931637|NCT03406793|Dietary Supplement|Dispersible zinc supplement|10 mg zinc in a dispersible tablet. Daily supplementation for 24 weeks.
15931638|NCT03406793|Dietary Supplement|Intermittent zinc supplement|10 mg zinc in a dispersible tablet. Daily supplementation for 14 days at baseline and 3 months, placebo tablet on all other days.
15931639|NCT03406793|Dietary Supplement|Placebo powder|Daily provision of a placebo powder for 24 weeks.
15931640|NCT03406780|Biological|CAP-1002|The active pharmaceutical ingredient in CAP-1002 is Cardiosphere-Derived Cells (CDCs). CDCs are known to secrete numerous bioactive elements (growth factors, exosomes) which impact the therapeutic benefits of the cell-based therapy. The mechanism of action is the composite ability to be immunomodulatory, anti-fibrotic and regenerative.
15931641|NCT03406780|Drug|Placebo|Placebo
15931642|NCT03406767|Other|GLA:D Canada Program|The GLA:D® program consists of 1) pre- and post-program outcome measurement (self-reported and functional outcomes); 2) 2, 1-1.5 hour education sessions including information on OA disease characteristics, treatments and self-help strategies; and 3) a neuromuscular exercise (warm-up, circuit training, and cool down) training program administered in 1 hour, small (up to 10 persons) group-based, supervised sessions twice weekly for 6 weeks. The goal of the exercises is to restore neutral, functional alignment of the legs by building compensatory functional stability and improving sensorimotor control.
15931643|NCT03406767|Other|JointEffort Program|The JointEffort program consists of: 1) one appointment aimed at individualized program design (1-1.5 hours); 2) a nutritional seminar taught by a registered dietician explaining dietary recommendations for OA patients and inflammatory conditions, including weight loss and/or management (1 hours); and 3) an individualized exercise (strength and neuromuscular training, balance training, and range of motion exercises) training program administered in 1 hour, small (up to 10 persons) group-based, supervised sessions twice weekly for 6 weeks.
15931644|NCT03406754|Behavioral|rehabilitation programs|an 8-week multidisciplinary inpatient rehabilitation program
15931645|NCT03406741|Behavioral|psychometric evaluation|Wechsler type composite scales (WISC)
15931646|NCT03406741|Behavioral|neuropsychological evaluation|Evaluation of child behavior by the Goodman questionnaire: Strengths and Difficulties Questionnaire
15931647|NCT03406728|Other|PDSAFEX|PDSAFEX is a week by week, progressive, exercise protocol that is followed. It lasts 12 weeks.
15931648|NCT03406728|Other|CONTROL|Participants will be asked to maintain their day to day life as consistently as possible for the 12 week duration of the study.
15931649|NCT03406728|Device|VIRTUAL REALITY|WorldViz Oculus Rift Move package (headset and software).
15931650|NCT03406715|Drug|Nivolumab|Nivolumab (BMS-936558) is an anti-PD-1 antibody. It works by attaching to and blocking a molecule called PD-1. Induction Immunotherapy Phase (4 x 21 days cycles): Nivolumab on Day 1 of each cycle for 4 cycles. Maintenance Immunotherapy beginning on Day 1 of Cycle 5: Nivolumab only on Day 1 of every 4 week period. Participants will continue to receive Nivolumab only on Day 1 of each additional 4 week period that they take part until their disease progresses. The Retreatment phase of the study may be available to participants whose doctor feels they would benefit from retreatment and if they qualify for this retreatment.
15931651|NCT03406715|Drug|Ipilimumab|Ipilimumab is an antibody (a type of human protein) that is approved to treat patients with metastatic melanoma. In this study, the use of ipilimumab is investigational. Induction Immunotherapy Phase (4 x 21 days cycles): Ipilimumab on Day 1 of each cycle for 4 cycles. The Retreatment phase of the study may be available to participants whose doctor feels they would benefit from retreatment and if they qualify for this retreatment.
15931652|NCT03406715|Biological|Dendritic Cell based p53 Vaccine|Dendritic Cell based p53 Vaccine (Ad.p53-DC). The p53 vaccine will be made by inserting the p53 gene (a gene is a hereditary unit of all living organism within a cell) into a subset of the participant's own white blood cells. The insertion of the gene into their white blood cells will occur in the laboratory, after their cells have been extracted from their body through a procedure called leukopheresis (similar to dialysis). Induction Immunotherapy Phase (4 x 21 day cycles): Participants will receive the p53 vaccine on Days 1 and 15 of cycle 1 and then again on Day 8 of Cycle 2. Maintenance Immunotherapy beginning on Day 1 of Cycle 5: p53 vaccine three additional times (every 4 weeks over a 12 week period).
15931653|NCT03406702|Drug|CX-8998|T-type calcium channel blocker
15931654|NCT03406689|Drug|Nepafenac 0.1% Oph Susp|One drop of Nepafenac 0.1% will be instilled 45' prior to the IVI.
15931655|NCT03406689|Drug|Nepafenac 0.3% Oph Susp|One drop of Nepafenac 0.3% will be instilled 45' prior to the IVI.
15931656|NCT03406689|Drug|Artificial tear|One drop Artificial Tears will be instilled 45' prior to the IVI.
15931657|NCT03406676|Drug|Methylene Blue|2mg / Kg of methylene blue in volume of 50ml is administrated I.V before anesthesia induction.
15931658|NCT03406663|Behavioral|Group 1|"Patients will be instructed to daily adjust their dose of Gla-300 based on fasting SMPG values. Fasting SMPG will be measured daily by the patient before breakfast and any intake of antihyperglycemic agents.
~Fasting SMPG in the range of
~≥ 5.6 mmol/L, increase 1 unit of Gla-300 dose, > 4.4 and ≤ 5.6 mmol/L, no change, < 4.4 mmol/L, reduce 1 unit of Gla-300 dose"
15931659|NCT03406663|Behavioral|Group 2|"Fasting SMPG (median of the last 3 days including current day) in the range of
~7.8 mmol/L, increase 6 units of Gla-300 dose, > 5.6 and < 7.8 mmol/L, increase 3 units of Gla-300 dose, > 4.4 and ≤ 5.6 mmol/L, no change,
~3.3 and < 4.4 mmol/L, reduce 3 units of Gla-300 dose, < 3.3 mmol/L or occurrence of ≥ 2 symptomatic or 1 severe hypoglycemic episode in the preceding week, reduce 3 units of Gla-300 dose or at the discretion of the investigator"
15931660|NCT03406650|Drug|Neoadjuvant and adjuvant durvalumab|Neoadjuvant durvalumab 1500 mg q3w for 4 cycles Adjuvant durvalumab 1500 mg q4w for 10 cycles
15931661|NCT03406637|Device|BPK-S Integration|primary total knee endoprosthesis
15931662|NCT03406624|Procedure|Biopsy|Biopsies will be taken from disc and / or bone during elective lumbar fusion surgery or disc herniation surgery
15931663|NCT03406611|Drug|Pegtibatinase|Pegtibatinase sterile solution for subcutaneous injection
15931664|NCT03406611|Drug|Placebo|Normal saline for subcutaneous injection
15931665|NCT03406598|Other|Patients in shock|Analysis of sublingual microcirculation by nurses in ICU patients in shock to predict needs for fluid challenge, vasopressors or transfusion.
15931666|NCT03406585|Drug|ProTrans: Allogeneic transplantation with WJMSCs|The IP is a cell suspension with MSC's procured from donated Wharton's Jelly from umbilical cord tissue and expanded in adherent culture over maximum of 3 passages. The treatment is allogenic.
15931667|NCT03406585|Drug|Placebos|Placebo treatment
15931668|NCT03406572|Device|HFHO Group|"Common name: humidifier with integrated flow generator that delivers high flow warmed and humidified respiratory gases
~Brand name: Airvo 2"
15931669|NCT03406572|Device|Standard O2|Standard oxygen therapy
15931823|NCT03405350|Procedure|Laser Therapy|treatment parameters: sweeping, continuous, wavelength 808 nm, power 12 J, 400mV, duration 30s,
15931670|NCT03406559|Other|orthodontic treatment|fixed orthodontic treatment in adolescent males initially treated with removable functional appliances for skeletal class II, Angle's class II division 2 malocclusion,
15931671|NCT03406546|Drug|Dexmedetomidine|Dexmedetomidine was used as a sedation agent with less side effect on respiratory system.
15931672|NCT03406546|Drug|Remifentanil|Remifentanil was used to prevent cough induced by bronchoscopy.
15931673|NCT03406546|Device|Laryngeal mask|Laryngeal mask was used to ensure respiration function during general anesthesia.
15931674|NCT03406533|Drug|Midazolam|Midazolam is used as a common medication for sedation in all groups.
15931675|NCT03406533|Drug|Dexmedetomidine|Dexmedetomidine is used for sedation in bronchoscopy with less impact on respiration.
15931676|NCT03406533|Drug|Remifentanil|Remifentanil is used for analgesia to prevent bronchoscopy induced cough.
15931677|NCT03406533|Drug|Fentanyl|Fentanyl is another opioid drug used for analgesia to prevent bronchoscopy induced cough.
15931678|NCT03406533|Drug|Propofol|Propofol is used for sedation with high efficacy but more side effect on respiration than dexmedetomidine.
15931679|NCT03406520|Device|Chlorhexidine-impregnated disk|The chlorhexidine-impregnated sponge, named biopatch, is a protective disk (2.5 cm x 0.7 cm), which is hydrophilic polyurethane absorptive foam with chlorhexidine gluconate, in average of 86.8mg per disk
15931680|NCT03406507|Biological|ALXN1210|Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight.
15931681|NCT03406494|Other|Early multicomponent physical therapy program|"Positioning (upright bed standing; turning, moving on bed).
~Peripheral muscle strength training (active or passive full range of motion, lower extremities ergometer cycling).
~Respiratory muscle training (supine abdominal breathing training).
~Neuromuscular electrical stimulation (NMES) on target muscles (bilateral bicipital muscles, quadriceps femoris muscles and rectus femoris).
~Gut rehabilitation (midfrequency NMES; abdominal manual or vibration massage)."
15931682|NCT03406468|Radiation|Radiotherapy|Patients continue the same immune therapy they already received and get radiotherapy to one lesion. The lesion may or may not be symptomatic. The preferred radiotherapy dose is 24 Gy in 3 fractions (dosage on the 10 Gy isodose is allowed), but other fractionation schedules (e.g. 30 Gy/ 10 fractions, 20 Gy/ 5 fractions, 20-24 Gy / 1 fraction for SRS (stereotactic radiosurgery)) are allowed if these are standard for a certain location or palliative indication in the body.
15931683|NCT03406442|Procedure|Transpterygoid approaches|All patients will be operated by transpterygoid approaches which is classified into 5 major types.Type A involves thinning of the pterygoid process to access to Pterygopalatine fossa. Type B involves the removal of the medial and anterior aspect of the base of the pterygoid process to access the lateral recess of sphenoid sinus. Type C involves removing the base of the pterygoid plates to reach the petrous apex, Meckel's cave, or cavernous sinus. Type D requires removal of the pterygoid plates to access the infratemporal fossa. Type E requires the removal of the medial pterygoid plate or the entire pterygoid process, and the medial third of the Eustachian tube to acessof the lateral nasopharynx
15931684|NCT03406429|Device|Active rTMS|All study participants will receive one block of active rTMS. Each block will consist of daily sessions of 20Hz active rTMS delivered to the left dorsolateral prefrontal cortex (dlPFC) over five days (Monday through Friday).
15931685|NCT03406429|Device|SHAM rTMS|All study participants will receive one block of SHAM rTMS. Each block will consist of daily sessions of 20Hz SHAM rTMS delivered to the left dorsolateral prefrontal cortex (dlPFC) over five days (Monday through Friday).
15931686|NCT03406416|Device|44Ch Bionic Eye Device|Prototype wide view suprachoroidal retinal prosthesis
15931687|NCT03406403|Device|Laryngeal mask airway|After obtaining approval of the ethics committee of Kasr Al Ainy Hospitals and informed written consents from the patients, this study will be performed on 20 patients in Kasr Al Ainy Hospitals with ASA physical status I, II and ages between 18 and 60 years undergoing undergoing supratentorial tumours excision under general anesthesia
15931688|NCT03406403|Drug|Magensium sulphate|After obtaining approval of the ethics committee of Kasr Al Ainy Hospitals and informed written consents from the patients, this study will be performed on 20 patients in Kasr Al Ainy Hospitals with ASA physical status I, II and ages between 18 and 60 years undergoing undergoing supratentorial tumours excision under general anesthesia
15931689|NCT03406403|Other|Control group (closure of anesthetics)|After obtaining approval of the ethics committee of Kasr Al Ainy Hospitals and informed written consents from the patients, this study will be performed on 20 patients in Kasr Al Ainy Hospitals with ASA physical status I, II and ages between 18 and 60 years undergoing undergoing supratentorial tumours excision under general anesthesia
15931690|NCT03406390|Procedure|Pterygium surgery|The patients were anesthetized with subconjunctival injection.Symblepharon was released and fibrotic tissue was extensively dissected to expose the sclera and corneal stroma. The subconjunctival fibrovascular tissue, including Tenon's capsule, were thoroughly removed using scissors from the sclera and medial rectus muscle at the area of the superior and inferior fornices and the nasal caruncle. A cryopreserved human amniotic membrane (Zhongshan Ophthalmic Center, China) was then placed on the entire exposed bare sclera with the epithelial side facing upward, and secured with 10-0 nylon sutures.
15931691|NCT03406377|Drug|OPK-88003|OPK-88003 subcutaneous injection
15931692|NCT03406377|Drug|Placebo|Placebo subcutaneous injection
15931693|NCT03406364|Drug|MG005|"Phase I:
~Eligible patients will receive different dosages of GW5074 in 1 of the 3 dose cohorts plus 200 mg of sorafenib. Dose cohorts will be escalated sequentially from Cohort 1 at 750 mg QD GW5074 plus 200 mg QD sorafenib to Cohort 2 at 1500 mg QD GW5074 plus 200 mg QD sorafenib, and Cohort 3 at 750 mg BID GW5074 plus 200 mg QD sorafenib. Owing to the fact that there is no previous human experience for GW5074, Cohort 1 will include a monotherapy stage with 750 mg QD GW5074 prior to administration of the GW5074 and sorafenib combination to initially assess the safety of GW5074 monotherapy."
15931694|NCT03406351|Other|Observational|Observational deep phenotyping physiological readouts
15931695|NCT03406338|Procedure|Fasciectomy|Surgical excision of Dupuytren cords causing finger joint contractures. Surgery done under regional or general anesthesia. Additional procedures (such as capsulotomy or skin graft) done if surgeon deemed necessary.
15931696|NCT03406338|Drug|Collagenase Clostridium Histolyticum|Injection of Collagenase into the Dupuytren cord after local anesthesia (nerve block) followed 24-48 hours later by finger manipulation after local anesthesia
15931824|NCT03405350|Procedure|Low-frequency Magnetic Field|duration 20 minutes, impulse shape - rectangular, induction 5 mT, frequency 20-50Hz,
15931697|NCT03406312|Diagnostic Test|Post Prandial Hypoglycemia test|three test assessing hypoglycemia will be used: liquid mixed meal tolerance test, solid mixed meal tolerances test, continuous glucose monitoring
15931698|NCT03406299|Drug|Tegafur|Tegafur(S-1) 35 mg/m2/b.i.d., day 1 - 7 (maximum dose: 120 mg/day)
15931699|NCT03406299|Drug|Leucovorin|Leucovorin 30 mg/b.i.d., day 1-7
15931700|NCT03406299|Drug|Oxaliplatin|Oxaliplatin 85 mg/m2 in 250 mL of 5% Glucose, given as 2-hour intra- venous infusion, day 1
15931701|NCT03406299|Drug|Gemcitabine|"Gemcitabine 800 mg/m2 in 250 mL of normal saline, given as fixed dose-rate (, 10 mg/m2/min) infusion, day 1; After the administration of gemcitabine, the infusion line should be flushed with 20 ml of normal saline and then 50 ml of 5% glucose solution before the administration of oxaliplatin. in SLOG arm.
~Gemcitabine 1000 mg/m2 in 100 mL of normal saline, IV drip for 30 mins on D1 and D8 ，in GC arm"
15931702|NCT03406299|Drug|Cisplatin|Cisplatin 25 mg/m2 in 250ml of normal saline, IV drip for 2 hours on D1 and D8
15931703|NCT03406286|Drug|Tolvaptan|
15931704|NCT03406273|Radiation|Cerebral Spinal (CS) radiation|Surgery plus Cerebral Spinal (CS) radiation
15931705|NCT03406273|Radiation|Focal radiotherapy (SRS)|Surgery plus focal radiotherapy (stereotactic radiosurgery to the tumor bed [SRS])
15931706|NCT03406260|Drug|Lasmiditan|Administered orally.
15931707|NCT03406260|Drug|Placebo|Administered orally.
15931708|NCT03406247|Drug|Nivolumab|"Patients in cohorts 1 and 1bis will be administered Nivolumab 240 mg every 2 weeks during 3 first months and then 480 mg every 4 weeks during 3 months Patients in cohorts 2 and 2bis will be administered
~- nivolumab 240 mg every 2 weeks during 6 months"
15931709|NCT03406247|Drug|Ipilimumab|"Patients in cohorts 2 and 2bis will be administered
~- ipilimumab 1mg/kg IV every 6 weeks during 6 months"
15931710|NCT03406234|Other|No intervention.|Cross-sectional observation without interventions.
15931711|NCT03406221|Behavioral|Information Communication Technology Continuum of Care Service|Mobile phones were made available to community health workers in the intervention arms that integrated a comprehensive set of functions to assist them in their duties, including registration and tracking of beneficiaries, automated scheduling of home visits, provision of health information through videos, guided protocols for conducting home visits through checklists, a feature to track child immunizations, and supervisory tools.
15931712|NCT03406221|Other|Control Condition|Standard of care
15931713|NCT03406208|Behavioral|Stress and Symptom Management Program 1|The Stress and Symptom Management Program 1 (SMP1) introduces and reinforces stress and symptom management skills. The program consists of 8 weekly sessions (90 minutes each), delivered through live videoconferencing.
15931714|NCT03406208|Behavioral|Stress and Symptom Management Program 2|The Stress and Symptom Management Program 2 (SMP2) introduces and reinforces stress and symptom management skills. The program consists of 8 weekly sessions (90 minutes each), delivered through live videoconferencing.
15931715|NCT03406195|Device|Transcranial magnetic stimulation (TMS)|TMS paradigm called theta burst stimulation
15931716|NCT03406169|Drug|Sildenafil 25 MG Oral Tablet|twice a day dosing
15931717|NCT03406169|Drug|Pentoxifylline|400mg twice a day
15931718|NCT03406169|Other|Placebo|placebo twice a day
15931719|NCT03406156|Drug|Obinutuzumab|intravenous
15931720|NCT03406156|Drug|Bendamustine|intravenous
15931721|NCT03406156|Drug|Venetoclax|tablet
15931722|NCT03406143|Procedure|CGF injection|CGF injection subdermally to expanded skin at the density of 0.02ml/cm2.
15931723|NCT03406143|Procedure|Control|Saline will be injected into expanded skin
15931724|NCT03406130|Procedure|Orthodontic Procedure|"Damon self-ligating systems (Ormco) were used for all patients. The patients were allowed to choose between clear and metal brackets. The bonding method was standardized and applied according to the manufacturer's instructions. After bracket bonding, 0.014-in. copper nickel-titanium Damon arch forms were placed. The subjects returned every 2 wk, and the archwires were changed only when full bracket engagement were achieved. The sequence of archwires was the following: 0.018-in., 0.014 × 0.025-in., and 0.018 × 0.025-in. copper nickel-titanium archwires were used for alignment, while 0.019 × 0.025-in. stainless-steel archwires were used for fine-tuning. Following the alignment steps, impressions were taken, and a blinded senior orthodontist validated appliance removal or provided advice regarding further adjustments.
~Alginate impressions were taken after the removal of the appliances, and fixed and removable retainers were placed."
15931725|NCT03406130|Procedure|Piezocision surgery|The piezocision surgery was performed 1 week after orthodontic appliance placement. The surgical protocol was performed as described by Dibart and al. (Dibart et al. 2009). However, to avoid bias, hard and soft tissue augmentations were not considered. The patients received local anesthesia in both arches; vertical interproximal microincisions were created below each interdental papilla. In cases of root proximity (i.e., <2 mm of interdental bone), this procedure was not performed. These incisions were kept to a minimum (varying from 5 to 8 mm). Next, with a vertical piezoelectric device, 5-mm-long and 3-mm-deep corticotomies were made, and no subsequent sutures were required. The patients were advised to take analgesics (paracetamol) only if necessary and to record their daily intake for 1 wk. Anti-inflammatories were prohibited to avoid interference with the RAP.
15931726|NCT03406117|Drug|HAT1|All the participants will have the test product applied to the appropriate test sites by trained study staff. The study was conducted on a mixed population comprising of normal subjects, and patients with atopic dermatitis and active plaque psoriasis.
15931727|NCT03406117|Other|Saline Solution|Only for CIT portion of the study. Participant will have product applied topically on site by the trained study staff.
15931728|NCT03406104|Genetic|GS010|Lenadogene nolparvovec Intravitreal occular unilateral Injection
15931729|NCT03406104|Other|Sham|Lenadogene nolparvovec Intravitreal occular unilateral Injection
15931730|NCT03406091|Drug|Plerixafor|Plerixafor (AMD3100) is a selective, reversible inhibitor of the receptor chemokine (C-X-C motif) receptor 4 (CXCR4) and prevents binding of its cognate ligand stromal cell derived factor-1α (SDF-1α), also known as chemokine (C-X-C motif) ligand 12 (CXCL12) [3]. CXCR4 is a co-receptor, along with CD4, for the binding of human immunodeficiency virus, type 1 (HIV-1) to its receptor cells.
15931731|NCT03406078|Biological|Tezepelumab|Tezepelumab subcutaneous injection
15931732|NCT03406078|Other|Placebo|Placebo subcutaneous injection
15931925|NCT03404674|Biological|dmLT|Escherichia coli double mutant heat-labile toxin with mutations at amino acids 192 and 211
15931733|NCT03406065|Dietary Supplement|Sodium bicarbonate supplementation|The experimental procedure for each athlete included a 10-day NaHCO3 supplementation in a progressive-dose regimen in order to reduce the likelihood of gastrointestinal side effects (from 25 to 100 mg ∙ kg-1). NaHCO3 was administered in the form of unmarked disk-shaped tablets (Alkala T, SANUM, Poland). The tablets were ingested with at least 250 mL of water and could be either swallowed or dissolved in the mouth. On training days the supplements were taken in the morning, in the evening and 1.5 hours before training session. On rest days the supplements were taken in the morning, in the afternoon and in the evening.
15931734|NCT03406065|Dietary Supplement|Placebo treatment|The experimental procedure for each athlete included a 10-day placebo administration. Placebo was ingested with at least 250 mL of water. On training days the supplements were taken in the morning, in the evening and 1.5 hours before training session. On rest days the supplements were taken in the morning, in the afternoon and in the evening.
15931735|NCT03406052|Behavioral|Smartphone-Assisted MB-CBT|Experimental subjects will receive a mindfulness-based CBT online software program workbook (in collaboration with Nex J Systems, Inc.) accessible online. Exposure to and interaction with the online workbook is combined with health coaching (duration of 24 total hours) primarily delivered in phone and software interactions. In addition, each participant will be given a Fitbit-HR Charge, a wearable bracelet that assesses physical steps and 24 hour heart rate in 5 second (averaged) durations (with related access to software that permits daily tracking).
15931736|NCT03406039|Behavioral|Integrated Online CBT and MI|The treatment condition will have access to 12 treatment modules and have 8-weeks to complete them. The content of all modules is derived from Cognitive Behavioural Therapy and Motivational Interviewing. Through module engagement, young adults will identify goals related to alcohol use and mood, learn strategies to cope with alcohol cravings, triggers, and social pressures, and learn how to prevent relapse. There will also be several modules to target anxiety and depression, focusing on strategies designed to help reduce negative thinking and worry, increase behavioural activation, and increase self-care (e.g., sleep hygiene).Participants will have immediate access to all modules, and it will be recommended that they work through the modules sequentially.
15931737|NCT03406026|Other|Balance System Protocol Stroke|This arm perform 5 sessions of 1 hour a week. All sessions will be performed by the same physiotherapist. One session consists of 45 minutes of regular physiotherapy and 15 minutes in which exercises will be carried out focused on the balance systems, following the program that is detailed below.
15931738|NCT03406026|Other|Control Stroke|This arm perform 5 sessions of 1 hour a week. All sessions will be performed by the same physiotherapist. The control group will perform, during the 60 minutes that the session lasts, the usual physiotherapy treatment.
15931739|NCT03406013|Behavioral|Written Information|Receive written information on diet and exercise relevant to older men with prostate cancer
15931740|NCT03406013|Behavioral|Prescription|Participants receive tailored exercise prescription and tailored diet recommendations
15931741|NCT03406013|Behavioral|Technology|Participants receive motivational text messages and can electronically log and track their exercise and diet habits
15931742|NCT03406013|Behavioral|Coaching|Participants receive access to an exercise and diet coach to provide advice by phone and/or email
15931743|NCT03406000|Drug|INSULIN GLARGINE (U300)|"Pharmaceutical form: Solution for Injection
~Route of administration: Subcutaneous injection"
15931744|NCT03405987|Diagnostic Test|Strain analysis by CMR|Strain analysis by CMR will be performed
15931745|NCT03405974|Drug|Aspirin|Aspirin (acetylsalicylic acid)
15931746|NCT03405974|Drug|Placebo|Placebo
15931747|NCT03405961|Device|Carestream 3600 intra oral scan|"Carestream 3600 is CE marked intra oral scanner manufactured by Carestream Dental. It is already licensed for use in dentistry to produce digital study models. The scanner is 220 x 38 x 58 mm large and operates using video capture technology. It emits no radiation.
~Carestream 3600 is connected to a computer via a USB port and a computer software (CS Model +) converts the scan into digital study models using trigonometric calculations. The software is then used to take measurements on the digital models and calculate PAR scores"
15931748|NCT03405948|Drug|Intra muscular injection of Botulinum toxin|posture and gait analysis were performed before injection and 4 to 6 weeks after injection
15931749|NCT03405935|Drug|B/F/TAF|50/200/25 mg FDC tablet administered orally once daily without regard to food.
15931750|NCT03405922|Drug|Placebo 40 mL Saline 0.9%|Injection of 40 mL 0.9% saline
15931751|NCT03405922|Drug|40 mL Ropivacain 0.5%|Ropivacaine Hcl 0.5% Injection 40 mL
15931752|NCT03405909|Diagnostic Test|contrast enhanced ultrasound (CEUS)|CEUS with SonoVue following standardized protocol
15931753|NCT03405909|Diagnostic Test|MRI|CE-MRI following standardized protocol
15931754|NCT03405909|Diagnostic Test|Histology|diagnostic liver biopsy
15931755|NCT03405896|Other|Turning|start to walk with normal speed, and then turn to approach the terminal under different angle.
15931756|NCT03405883|Other|Vaginal swab + endometrial biopsy|In the midluteal phase of the cycle, a vaginal swab (E swab) and endometrial biopsy (TAO brush) will be obtained.
15931757|NCT03405870|Drug|Smoflipid|Administration of lipid injectable emulsion
15931758|NCT03405857|Other|Cognitive rehabilitation program|Cognitive rehabilitation programs have been developed to improve the cognitive functions of the elderly or patients with cognitive impairments. The program includes sub-categories such as attention, working memory, memory and executive functions with various levels of difficulty.
15931759|NCT03405831|Drug|Ivabradine|Ivabradine, oral tablets, 5 mg, coated in gelatine capsules to ensure blinding, 1 capsule twice a day, for a period of 12 weeks
15931760|NCT03405831|Drug|Placebo|Placebo, gelatine capsules to ensure blinding, 1 capsule twice daily, for a period of 12 weeks
15931761|NCT03405818|Drug|Tavaborole 5% Topical Solution|topical solution for application to toenails
15931762|NCT03405805|Biological|13-valent pneumococcal conjugate vaccine (PCV13)|Vaccination with PCV13
15932034|NCT03403842|Device|Sublingual sufentanil tablet system|Administration of sublingual sufentanil with a PCA
15931766|NCT03405779|Procedure|Lung ultrasonography|Mechanically ventilated patients suffering from pulmonary diseases will undergo a lung ultrasonography during their stay in the intensive care unit (ICU)
15931767|NCT03405753|Dietary Supplement|Aronia, washout and then placebo|Three tablets three times à day for three months then washout for three months, then three placebo tablets three times à day for three months. Blood samples and semen samples collected before and after each period of tablet intake.
15931768|NCT03405753|Dietary Supplement|Placebo, washout and then aronia|Three tablets three times à day for three months, then washout for three months, then three aronia tablets three times à day for three months. Blood samples and semen samples collected before and after each period of tablet intake.
15931769|NCT03405740|Device|Remote Patient Management|"Transmissions will occur at six monthly intervals, with no in-clinic visits. If there is an actionable event on the remote transmission, patients will be seen at their closest community clinic.
~All patients will be required to follow up with their family physician at least annually, and their cardiologist at least every 2 years.
~Patients will be contacted by phone at 6 months and 12 months to document their current health status (change in cardiovascular medications, any cardiovascular hospitalizations, in-clinic device checks, or any new cardiovascular testing completed since the last visit)
~VIRTUES access"
15931770|NCT03405740|Device|Standard of Care|No intervention
15931771|NCT03405727|Dietary Supplement|Oral dietary supplements|Protein enriched diet
15931772|NCT03405714|Drug|Brivaracetam|"Pharmaceutical form: Solution for iv injection
~Route of administration: intravenous use
~Concentration: 10 mg/ml"
15931773|NCT03405701|Procedure|IVM|Patients in IVM group will receive FSH (Menopur, Ferring) for 2 days on day 2/3 of the menstrual cycle (spontaneous/ OCP administration) and the ultrasound scan will be performed subsequently. Oocytes retrieval will be performed 42 hours after the last injection. Pre-maturation will last for 24-30 hours. ICSI will be used for insemination. Freeze-only on day 3 and frozen embryo transfer will be performed on the subsequent cycle using HRT protocol with a maximum of 2 embryos transferred.
15931774|NCT03405701|Procedure|IVF|Patients in IVF arm will undergo controlled ovarian hyperstimulation with recombinant FSH (Menopur, Ferring) in GnRH antagonist protocol, treatment monitoring using ultrasound scans and blood tests. GnRH agonist will be used for final oocytes maturation. ICSI will be used for insemination. Freeze-only on day 3 and frozen embryo transfer will be performed on the subsequent cycle using HRT protocol with a maximum of 2 embryos transferred.
15931775|NCT03405688|Procedure|Blood sampling|Extra blood samples taken for laboratory analysis
15931776|NCT03405675|Other|SLAS 1|NA. Observational study, no interventions administered.
15931777|NCT03405675|Other|SLAS 2|NA. Observational study, no interventions administered.
15931778|NCT03405662|Device|Vielight Neuro Gamma|The Vielight Neuro Gamma is headset that delivers transcranial (through the scalp and skull) and intranasal (through the nose) near infrared (NIR) light. The device is engineered for increased efficacy and easy domestic use for comprehensive brain photobiomodulation (PBM). The NIR lights are pulsed at a 40 Hz rate, which correlates with electroencephalogram (EEG) gamma brain wave entrainment.
15931779|NCT03405662|Other|Sham Vielight Neuro Gamma|The Sham Vielight Neuro Gamma headset is identical to the active Vielight Neuro Gamma headset and intranasal light emitting diode (LED) except it has a power output of 0.
15931780|NCT03405649|Behavioral|Group A|Muscle conditioning exercise for postpartum women and infants less than 20 weeks of age.
15931781|NCT03405649|Behavioral|Group B|Muscle conditioning exercise for postpartum women and infants more than 20 weeks of age.
15931782|NCT03405636|Device|Xeltis Pulmonary Valved Conduit|RVOT reconstruction
15931783|NCT03405623|Procedure|Dynamic needle tip positioning under ultrasound-guidance|The tip of needle is positioned under ultrasound-guidance using dynamic short-axis view.
15931784|NCT03405623|Procedure|Conventional long-axis view|The tip of needle is positioned under ultrasound-guidance using conventional long-axis in-plane view.
15931785|NCT03405610|Behavioral|The Toolkit for Optimal Recovery after Injury|The Toolkit for Optimal Recovery after Injury (ToR) is a skills based mind body program that was designed to prevent the development of chronic pain and disability following an acute musculoskeletal injury (e.g., fracture). The program has 4 sessions and it is delivered via live video. Patients learn myth about recovery after injury, false and real pain alarms, the fear avoidance model and how to prevent the disability spiral, mindfulness based exercises and activity pacing.
15931786|NCT03405597|Drug|Commercial Hepatitis B vaccine|Commercial Hepatitis B vaccine (Engerix B) 20 microgram subcutaneous injection at month 0, 1, 6
15931787|NCT03405597|Other|Standard Treatment|HBsAg, HBsAb test Ultrasound upper abdomen every 6 months
15931788|NCT03405584|Drug|Esomeprazole|Proton pump inhibitor
15931789|NCT03405584|Drug|Amoxicillin|Antibiotic for H. pylori eradication
15931790|NCT03405584|Drug|Bismuth Potassium Citrate|Gastric mucosal protective drug with anti-H. pylori effect
15931791|NCT03405571|Other|No intervention|No intervention
15931792|NCT03405558|Other|No intervention|As this is an observational study, we will only supervise testing and training sessions which were performed anyway during first rehabilitation as daily therapeutic routine
15931793|NCT03405545|Behavioral|High-intenstiy interval training|High-intensity interval training is a training of 30 minutes involving 10 bouts of 1 minute high intensity cycling (80-90% of maximum heart rate) interspersed by 2 minutes rest.
15931794|NCT03405532|Diagnostic Test|DM-ECC|Diabetes mellitus CPB
15931795|NCT03405519|Procedure|Radiotherapy planning using both CT and MRI scans|Patients' radiotherapy will be planned using CT and MRI scans in order to establish the best methodology for planning of radiotherapy for nodal disease
15931796|NCT03405506|Device|Quantitative Flow Ratio (QFR)|FFR measured by pressure wire, QFR computed by coronary angiographic images
15931825|NCT03405350|Procedure|Ultrasonotherapy|treatment parameters: 800kHz/6cm2 head, ultrasound impulse wave: 2ms - impulse, 9ms - break, dose 0.5-0.6 W/cm2 over 6 minutes,
15931826|NCT03405350|Procedure|Cryotherapy|ventilator, treatment duration 2-3 minutes, temperature - 80 to - 110 degrees Celsius,
15932100|NCT03403296|Genetic|nProfiler I Stomach Cancer Assay Kit|qPCR by nProfiler I Stomach Cancer Assay Kit
15931797|NCT03405493|Behavioral|Wake and Light Therapy|Participants will be helped to change the pattern sleep by depriving participants of sleep for one night. On Day 1 participants will be supported to stay up all night and the following day at the Hospital. Participants can go to bed by 5pm at home on Day 2. Participants will need to get up by about 1am and return to the hospital to be supported to stay awake. Participants will then go to bed at 7pm on Day 3. Participants will be asked to sleep until 3am and then stay awake at home until bed at 9pm on Day 4. Participants will then get up by 5am on Day 5 and stay awake until 11pm to resume a normal sleep routine waking by 7am on Day 6. Participants will also be given a light box to use each morning. For the light box, participants will be asked to sit about one foot away from a light box. You will be free to have breakfast, read or use a computer while facing towards the light. Treatment with a light box will last 30 minutes. Participants may continue to have treatment as usual.
15931798|NCT03405493|Behavioral|Sleep and Light Therapy|Participants will be given information and advice on how to get a good night's sleep. Participants will be also given a light box to use in the morning for 1 week. For the light box, participants will be asked to sit about one foot away from a light box. Participants will be free to have breakfast, read or use a computer while facing towards the light. Treatment with a light box will last 30 minutes when you get up. Participants may continue to have any treatment as usual (for example medication or talking therapies).
15931799|NCT03405480|Other|Rehabilitation|Rehabilitation
15931800|NCT03405467|Other|general and specific data|General and specific data collected
15931801|NCT03405454|Drug|durvalumab|Durvalumab will be given at 1500mg fixed dose every 4 weeks for 24 months or until the appearance of significant treatment-related toxicity or disease progression
15931802|NCT03405454|Drug|standard chemotherapy|chemotherapy treatment will be administered as per local institutional guidelines
15931803|NCT03405441|Drug|JNJ-55375515 Dose Level 1|Participants will receive JNJ-55375515 orally at a Dose level 1 in Part 1 of study.
15931804|NCT03405441|Drug|JNJ-55375515 Dose Level 2|Participants will receive JNJ-55375515 orally at a Dose level 2 in Part 1 of study.
15931805|NCT03405441|Drug|JNJ-55375515 Dose Level 3|Participants will receive JNJ-55375515 orally at a Dose level 3 in Part 1 of study.
15931806|NCT03405441|Drug|JNJ-55375515 Dose Level 4|Participants will receive JNJ-55375515 orally at a Dose level 4 in Part 1 of study.
15931807|NCT03405441|Drug|JNJ-55375515 Dose Level 5|Participants will receive JNJ-55375515 orally at a Dose level 5 in Part 1 of study.
15931808|NCT03405441|Drug|JNJ-55375515 Dose Level 6|Participants will receive JNJ-55375515 orally at a Dose level 6 in Part 1 of study.
15931809|NCT03405441|Drug|Placebo|All participants will receive matching placebo orally in Part 1 and Part 2 of the study.
15931810|NCT03405441|Drug|JNJ-55375515|Participants will receive JNJ-55375515 as per the assigned treatment in Part 2.
15931811|NCT03405428|Other|Allen test|Before induction, with firm occlusive pressure held on both the radial and ulnar arteries, the patient is asked to clench his or her fist several times until the palmar skin is blanched. The patient is then instructed to unclench the fist, and then ulnar artery pressure is released while maintaining occlusion of the radial artery. Overextension of the hand and wide spreading of the fingers should be avoided because it can lead to falsely abnormal results. The time required for palmar capillary refill is noted. An abnormal Allen test result was defined as a recovery time of more than 10 seconds.
15931812|NCT03405428|Other|Radial artery diameter measurement by ultrasonography|Ultrasonography measurements will be performed with a linear probe before and after induction. The non-dominant hand of the patient will be fixed in the anatomical position on the arm chair. The wrist joint of patient will be extended to 30 degrees with a wrist pad. The USG probe will be transversally placed 2 cm proximal to the styloid process and the short axes of the radial artery will be scanned. The diameter of the radial artery will be measured and recorded.
15931813|NCT03405428|Other|Ulnar artery doppler ultrasonography|Ultrasonography measurements will be performed with a linear probe before and after induction. The non-dominant hand of the patient will be fixed in the anatomical position on the arm chair. The wrist joint of patient will be extended to 30 degrees with a wrist pad. The USG probe will be transversally placed 2 cm proximal to the styloid process and the short axes of the ulnar arter will be scanned. The blood fow of ulnar artery will be measured and recorded.
15931814|NCT03405415|Device|Blood glucose monitoring system and continuous interstitial glucose monitoring system|"At enrolment, participants are provided with BGM (Blood Glucose Monitoring) and CGM (Continuous Glucose Monitoring) systems. They will use the systems throughout the study. Participants will visit the study site three times. During the first visit, a standardized oral glucose tolerance test will be performed to ensure that participants do not have diabetes mellitus and to obtain glucose concentration data from people without diabetes mellitus during a glucose challenge. On another two days, participants will visit the study site for standardized breakfast and lunch meals to provide glucose concentration data under standardized conditions.
~Outside of the study site visits, participants are asked to eat similar meals on two days to obtain glucose concentration data under repeated conditions that represent daily life.
~During the study, participants are asked to document meals, physical activity and addition comments to provide context to the recorded glucose concentration data."
15931815|NCT03405402|Procedure|Blood sampling|Extra blood sampling at the time of a blood transfusion in order to perform the laboratory analysis
15931816|NCT03405389|Procedure|MatrixWAVE MMF System|Standard of care treatment of the injury and use of the MatrixWAVE MMF system to establish occlusion
15931817|NCT03405376|Drug|Intravitreal aflibercept injection|Aflibercept 2mg is injected into the vitreous cavity through the pars plana using 30G needle-attached syringe for branch retinal vein occlusion.
15931818|NCT03405350|Procedure|Redon-sulfide baths|Encompassing whole body or isolated limbs - upper and/or lower limbs - temperature: 37-38 degrees Celsius, duration: 20 minutes.
15931819|NCT03405350|Procedure|Partial Mud Baths|duration: 20 minutes, temperature 40-42 degrees Celsius
15931820|NCT03405350|Procedure|Kinesiotherapy|It is the therapeutic treatment of disease by passive and active muscular movements (as by massage) and of exercise. It is the core element of physiotherapy/physical therapy. Kinesiotherapy - duration of 30-45 min.
15931821|NCT03405350|Procedure|Terrain Therapy|walking, outdoors physical activities,
15931822|NCT03405350|Procedure|Dry Massage|Depending on the needs of each patient it involved cervical (CC), thoracic (TH), or lumbar spine (LS).
15931892|NCT03404908|Drug|metamizole|Intravenous metamizole will be used (1.0 gram), up to 4 grams per day
15931827|NCT03405350|Procedure|Electrotherapy|Bernard's diadynamic currents - treatment parameters: DF1 CP4 LP4, Nemec interference currents (frequency range 0-100Hz), percutaneous electrostimulation (TENS) - rectangular impulse currents, impulse duration 0.2ms, frequency 40Hz, regulated current 0-100mA,
15931828|NCT03405350|Procedure|Light Therapy|blue filter Sollux lamp, radiation distance 30-40 cm, duration 15 minutes, Bioptron lamp - radiation distance 10 cm, duration 5-10 minutes
15931829|NCT03405337|Drug|FVIII products|Adynovate, Eloctate, Afstyla, Kovaltry
15931830|NCT03405337|Drug|Conventional FVIII replacement therapies|Advate, Kogenate FS, Helixate, Novoeight, Nuwiq, Recombinate, Xyntha
15931831|NCT03405324|Device|tDCS|a single session of tDCS over the primary motor cortex with constant current of 2mA intensity will be applied for 20 minutes with a 5-second ramp phase at the beginning.
15931832|NCT03405324|Device|sham tDCS|sham tDCS
15931833|NCT03405311|Device|Rivanna Accuro 3D Ultrasound Device|The treatment group (Group 1: Ultrasound and Epidural) will receive epidural analgesia using ultrasound pre-procedural scan with the ACCURO device
15931834|NCT03405311|Other|Palpation|The control group (Group 2: Epidural) will receive the 'Blind approach/palpation', which is using palpation in administering labor epidural analgesia. Additionally, anesthesiologist will scan patient's back with Accuro device in turned off mode
15931835|NCT03405298|Behavioral|Educational Material|Educational material is in the form of a brochure
15931836|NCT03405298|Behavioral|Supplemental Collaborative Care|Supplemental care management consist of meeting with a behavioral health care manager over five sessions in-person or via phone call; the care manager will review patient information with the consulting psychiatrist, who can then make recommendations back to the primary care provider
15931837|NCT03405285|Device|Connected Catheter|The Connected Catheter is a fully internal, urethral-indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization, including neurogenic lower urinary tract dysfunction (NLUTD - e.g. due to spinal cord injury). The CoCath is a sterile, single-extended-use device that resides fully internally to the male lower urinary tract (urethra + bladder neck) for an intended service life of up to 29 days per Catheter.
15931838|NCT03405272|Biological|Recombinant Anti-EGFR Monoclonal Antibody（SCT200）|Experimental: recombinant anti-EGFR monoclonal antibody（SCT200） Recombinant Anti-EGFR Monoclonal Antibody（SCT200）. Initially, SCT200 6.0mg/kg will be administered at day 1 every week for a maximum of 6 cycles. After 6 cycles SCT200 8.0mg/kg will be administered at day 2 every weeks until disease progression.
15931839|NCT03405259|Device|Super Seal® Desensitizer|Single dose professional application.
15931840|NCT03405259|Device|Acclean® Fluoride Varnish|Single dose professional application.
15931841|NCT03405246|Behavioral|KIDFIT HEALTHY|KIDFIT Healthy intervention combines traditional in-person and electronic participant contacts.
15931842|NCT03405246|Behavioral|KIDFIT SAFE|KIDFIT Safe group will be referred to the KIDFIT Safe website for monthly Homestyles Safe Guides about safe home environments for raising children and related material emailed monthly to the moms.
15931843|NCT03405233|Procedure|Double vein cuffed ePTFE graft both at the inflow and outflow ends|Vein cuff is obtained from a segment of one of the arm veins (cephalic or basilica) after incising it longitudinally and wrapped around both ends of PTFE Graft
15931844|NCT03405233|Procedure|single vein cuffed eTFE graft both at the inflow and outflow ends|Vein cuff is obtained from a segment of one of the arm veins (cephalic or basilica) after incising it longitudinally and wrapped around the venous end of PTFE Graft
15931845|NCT03405233|Procedure|ePTFE graft without any cuff|anastmosis between arterial and venous side usinf non cuffed ePTFE graft
15931846|NCT03405220|Behavioral|Self affirmation, 10 items, written examples|"Participants will complete the 10 item self-affirmation kindness quiz and will be asked to provide written examples for each item they respond yes to."
15931847|NCT03405220|Behavioral|Self affirmation, 10 items, no examples|"Participants will complete the 10 item self-affirmation kindness quiz and will not be asked to provide examples for any items they respond yes to."
15931848|NCT03405220|Behavioral|Self affirmation, 10 items, imagined examples|"Participants will complete the 10 item self-affirmation kindness quiz and will be asked to imagine examples for each item they respond yes to."
15931849|NCT03405220|Behavioral|Self affirmation, 5 items, written examples|"Participants will complete a 5 item self-affirmation kindness quiz and will be asked to provide written examples for each item they respond yes to."
15931850|NCT03405220|Behavioral|Self affirmation, 5 items, no examples|"Participants will complete a 5 item self-affirmation kindness quiz and will not be asked to provide examples for any items they respond yes to."
15931851|NCT03405220|Behavioral|Self affirmation, 5 items, imagined examples|"Participants will complete a 5 item self-affirmation kindness quiz and will be asked to imagine examples for each item they respond yes to."
15931852|NCT03405220|Behavioral|Self affirmation, 3 items, written examples|"Participants will complete a 3 item self-affirmation kindness quiz and will be asked to provide written examples for each item they respond yes to."
15931853|NCT03405220|Behavioral|Self affirmation, 3 items, no examples|"Participants will complete a 3 item self-affirmation kindness quiz and will not be asked to provide examples for any items they respond yes to."
15931854|NCT03405220|Behavioral|Self affirmation, 3 items, imagined examples|"Participants will complete a 3 item self-affirmation kindness quiz and will be asked to imagine examples for each item they respond yes to."
15931855|NCT03405207|Drug|Vitamin D3 50000 UNT Oral Capsule|Holick's protocol of treating vitamin D deficiency lasting for 8 weeks
15931856|NCT03405207|Drug|Placebo oral capsule|identical as active drug providing by pharmaceutical company unless it is placebo
15931857|NCT03405194|Drug|Elvitegravir, Cobicistat, TAF, FTC|Started on day of HIV diagnosis
15931858|NCT03405194|Drug|Efavirenz, TDF, and 3TC|Started on day of HIV diagnosis
15931893|NCT03404908|Drug|Ketoprofen|Intravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day
15931894|NCT03404908|Drug|Morphine|Intravenous morphine (5 mg) will be given when pain exceeds 40 mm in VAS (maximum 2 doses per day)
15931926|NCT03404661|Drug|Synthetic Human Secretin|Subjects will receive a dose of 0.2ng/kg while the endoscope is positioned in the second portion of the duodenum.
15931927|NCT03404648|Drug|C-11 choline PET tracer|C-11 choline PET tracer, One dose, totally 12-14 millicurie (mCi), intravenous administration while patient is lying on the table.
15931859|NCT03405181|Other|Training with additional weight|The infants will be positioned in a reclined position. A bracelet with an additional weight (20% of the total mass of the upper limb) will be placed on both wrists. The training will happen 2x/week, during 4 weeks (8 sessions). An object will be used to stimulate the reaching behavior, which will be displayed by the examiner (positioned in front of the infant), and presented in the midline at shoulder height, considering the distance from the arm's length of the infant to the height of the wrist. The physiotherapist will draw the attention of the infant to the object, moving it momentarily so that the infant perceives it and reaches it. After reaching, the object will be carefully removed and resubmitted in order to elicit a new movement. The interval between each presentation will be of approximately 5 seconds. At least 10 movements will be stimulated. If the infant does not achieve the 10 reaches within the maximum interval of 15 minutes, the session will be terminated.
15931860|NCT03405181|Other|Training without additional weight|The infants will be positioned in a reclined position. A bracelet without the additional weight will be placed on both wrists. The training will happen 2x/week, during 4 weeks (8 sessions). An object will be used to stimulate the reaching behavior, which will be displayed by the examiner (positioned in front of the infant), and presented in the midline at shoulder height, considering the distance from the arm's length of the infant to the height of the wrist. The physiotherapist will draw the attention of the infant to the object, moving it momentarily so that the infant perceives it and reaches the object. After reaching, the object will be carefully removed (or picked up) and resubmitted in order to elicit a new movement. The interval between each presentation of the object will be of approximately 5 seconds. At least 10 movements will be stimulated. If the infant does not achieve the 10 reaches within the maximum interval of 15 minutes, the session will be terminated.
15931861|NCT03405168|Drug|Moxifloxacin Hydrochloride 400mg Tablet|Moxifloxacin is oral administration, 400 mg once a day, D1 to D7, 28 days as one cycle.
15931862|NCT03405155|Biological|Nivolumab|Given IV
15931863|NCT03405142|Drug|Panitumumab-IRDye800|50 mg infusion
15931864|NCT03405142|Drug|Lymphoseek|2 mCi, infusion
15931865|NCT03405129|Behavioral|Phoenix|Phoenix cessation app
15931866|NCT03405129|Behavioral|NRT order button|Ability to order NRT through smartphone app
15931867|NCT03405129|Behavioral|Factoid|Factoid app
15931868|NCT03405103|Behavioral|Striving|
15931869|NCT03405103|Behavioral|Boning-Up|
15931870|NCT03405103|Behavioral|Personal Choice|
15931871|NCT03405090|Drug|Fentanyl Citrate|100 mcg fentanyl citrate will be inhaled via nebulizer
15931872|NCT03405090|Drug|Combivent|0.5 mg ipratropium bromide + 2.5 mg salbutamol will be inhaled via nebulizer
15931873|NCT03405077|Behavioral|IPT Online Training|"First, college mental health clinicians will complete baseline online questionnaires and deliver their usual treatment to 1 or 2 clients with symptoms of eating disorders. Then, they will complete the guided online training program and post-training assessments. Next, they will treat 1 or 2 different clients with eating disorders and complete post-training assessments. As part of the baseline and post-training assessments, clinicians will complete a telephone-based simulation assessment with staff raters, in which the investigators will recreate a client session and rate how well the clinicians adhere to IPT in treating the simulated client. The guided on-line training program will ultimately be compared to the gold standard training."
15931874|NCT03405064|Drug|Oral Levonadifloxacin/Linezolid Tablet|oral levonadifloxacin (1000 mg BID) or oral linezolid (600 mg BID)
15931875|NCT03405064|Drug|Intravenous Levonadifloxacin/Linezolid Infusion|IV levonadifloxacin (800 mg BID) or IV linezolid (600 mg BID)
15931876|NCT03405025|Procedure|Endoscopic ultrasound guided radiofrequency ablation|To establish if radiofreuqency ablation of aldosterone producing adrenal adenomas can be carried out via the endoscopic route and to assess safety of the procedure.
15931877|NCT03405025|Device|ultrasound|ultrasound
15931878|NCT03404999|Other|clinical decision support|Decision support system (see description of hypertension decision support system alerts and order sets for details)
15931879|NCT03404986|Procedure|ureteroscopy|The patients will be subjected to rigid ureteroscopy
15931880|NCT03404986|Radiation|Ultrasonography|The patients will be subjected to Ultrasonography
15931881|NCT03404960|Drug|Niraparib + Nivolumab|Niraparib 200mg PO daily on days 1-21 of each 21 day cycle Nivolumab 240mg IV days 1 and 15 of odd-numbered cycles; day 8 of even numbered cycles
15931882|NCT03404960|Drug|Niraparib + Ipilimumab|Niraparib 200mg PO daily on days 1-21 of each 21 day cycle Ipilimumab 3mg/kg IV day 1 of each cycle, for the first 4 cycles only
15931883|NCT03404947|Dietary Supplement|Ethanol|For one exercise session, participants will be asked to ingest a quantity of ethanol (in the form of vodka) sufficient to maximally stimulate liver alcohol metabolism.
15931884|NCT03404934|Device|C-REX Ring-locking Procedure|"The C-REX Ring-locking Procedure is a method based on adaptive anastomosis, in which intestinal ends adapt to each other after resection due to tumor, injury, or other disease.
~The investigational devices comprised of two components, i.e. C-REX LapAid and C-REX DMH/DMHC"
15931885|NCT03404921|Procedure|ESTD|During the ESTD procedure,after marking and submucosal injection, incisions were made at both the anal and oral sides of the lesion, and the submucosa under the lesion was then dissected to create a tunnel between the distal and proximal incisions. When the endscope reached the lower incision, the distal end of the esophageal lumen could be visualized , then two lateral mucosal incisions were made, thus completing the ESD procedure.
15931886|NCT03404921|Procedure|ESD|The ESD procedure involved marking,injection,circumferential cutting, submucosal dissection.
15931887|NCT03404908|Procedure|TAP (transversus abdominis plane block)|the ultrasound-guided regional block of abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.375% ropivacaine administered (0.2 mL/kg).
15931888|NCT03404908|Procedure|QL (quadratus lumborum block)|the ultrasound-guided regional block of abdominal wall muscles to treat acute pain, similar to transversus abdominis plane block, but with a distribution of local anesthetic towards paravertebral space. Stimuplex Ultra 360 needle will be used and 0.25% bupivacaine administered (0.2 mL/kg).
15931889|NCT03404908|Drug|Ropivacaine|In both groups (TAP&QLB) 0.375% ropivacaine will be given (0.2 mL/kg)
15931890|NCT03404908|Device|Needle|Ultrasound-guided, Stimuplex ultra 360 needle will be used in the study
15931891|NCT03404908|Drug|paracetamol|Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day
15966234|NCT03140683|Device|non-stress test|antepartum fetal monitoring
15931895|NCT03404895|Device|Conventional Therapy|Local wound care consists of at least once daily dressing Occasionally, a limited bedside debridement is indicated to excise small quantity of devitalized tissues and to provide better drainage. Antibiotic therapy including both gram-positive and gram-negative coverage when the DFU appears infected is guided by wound cultures and when necessary, Infectious Disease consultation. Debridement and amputation will be performed as clinically indicated. To promote healing after the more acute processes have been addressed, pressure offloading is frequently helpful in the healing of DFU. Pressure offloading treatment ranges from special dressings and devices to special diabetic foot wares. Offloading will be utilized as indicated.
15931896|NCT03404895|Device|Venous Stent(s)|After PVOO is confirmed by venography and IVUS, and patient subject is randomized to conventional therapy and stent placement, stent placement is performed immediately at the same sitting.
15931897|NCT03404882|Behavioral|Supportive/reminder text messaging plus peer support|Regular supportive/reminder text message will be delivered to patients who will also receive face to face and interactive text message support from peer support workers
15931898|NCT03404882|Behavioral|Supportive/reminder text messaging|Regular supportive/reminder text message will be delivered to patients who will NOT receive any face to face or interactive text message support from peer support workers
15931899|NCT03404882|Behavioral|Peer support only|face to face support from peer support workers but no interactive or daily supportive/reminder text messages
15931900|NCT03404869|Drug|ORL-1M - D-mannose|Oral ORL-1M
15931901|NCT03404856|Drug|ORL-1G - D-galactose|Oral ORL-1G - D-galactose
15931902|NCT03404843|Drug|Fasudil Hydrochloride|10 mg/mL vial of fasudil hydrochloride. 6 mL (60 mg) of fasudil hydrochloride are added to a 100 mL saline bag for delivery to subjects.
15931903|NCT03404843|Other|Saline|100 mL saline bag.
15931904|NCT03404830|Other|HIIT group, MICT group|"The HIIT program training:
~5 minutes of heating will be done. The intervention will consist of a training in suspension (TRX) performing squats. The session will be divided into four four-minute intervals at an intensity of 90-95% of the maximum heart rate, followed by three-minute active rest intervals of 50-70%. This intensity will be assigned to each subject individually. After the training, there will be a return to calm of 10 minutes of exercises of joint range. There will be 2 weekly training, with three days between both training, for a period of 12 weeks.
~The training of the MICT program:
~5 minutes of heating will be done. Subsequently, participants will perform a squat training with the Suspension Training System (TRX) with an intensity close to 70% of their maximum heart rate maintained for 40 minutes. The session will conclude with a return to calm of 10 min of joint width and stretching."
15931905|NCT03404817|Drug|Original formulation EMB-001|Single oral dose (720 mg metyrapone/24 mg oxazepam)
15931906|NCT03404817|Drug|New formulation EMB-001|Single oral dose (720 mg metyrapone/24 mg oxazepam)
15931907|NCT03404804|Drug|Amoxicillin|Oral challenge with amoxicillin in patients who are deemed low-risk for true penicillin allergy
15931908|NCT03404791|Drug|TAR-200|TAR-200 will be placed for 21-day dosing cycles, with up to 7 doses per participant.
15931909|NCT03404778|Device|Biomet Comprehensive Reverse Shoulder|Designed to eliminate the potential for scapular notching, this reverse shoulder system combines a a true locking mechanism that minimized wear and oxidative breakdown with a modular central screw for secure fixation.
15931910|NCT03404765|Behavioral|Tai Chi|
15931911|NCT03404752|Drug|Peg-Filgrastim|
15931912|NCT03404739|Drug|Saline Solution|These patients will be given only one dose of ceftazidime at the start of POEM plus 2 doses of saline solution every 12 hours after the procedure.
15931913|NCT03404739|Drug|Ceftazidime|These patients will be given ceftazidime 2g at the start of POEM plus additional 2 doses given every 12 hours after the procedure.
15931914|NCT03404726|Drug|BAY2402234|BAY2402234 is a potent and selective small molecule inhibitor of dihydroorotate dehydrogenase. A solution of BAY2402234 will be available to initiate the trial and there are plans to transition to a tablet form of BAY2402234 once it becomes available. Both liquid and tablet formulations of BAY2402234 will be continually administered once daily by mouth in 28 day cycles.
15931915|NCT03404713|Behavioral|Pathways to Health|Manualized sessions will follow an acceptance based behavioral weight loss treatment approach, including guided goal-setting and self-monitoring, identifying barriers and solutions, contingency management, stimulus control, dealing with setbacks and relapse prevention. Daily food and physical activity are logged and monitored. Parents learn strategies to support and facilitate their child's weight management via family-based change.
15931916|NCT03404713|Behavioral|Be4U|This intervention is grounded in Cognitive Behavioral Therapy (CBT), Dialectical Behavioral Therapy (DBT), and Acceptance and Commitment Therapy (ACT). The core elements include regulating eating patterns, self-monitoring, developing openness to an acceptance perspective, fostering a willingness to accept distress, teaching defusion from distressing thoughts and feelings, practicing mindful awareness, fostering self-as-context, and directing patients towards clarifying and focusing on life values. Self-monitoring of eating behaviors and emotions are encouraged using a free app that facilitates electronic self-monitoring of eating patterns and symptoms. For participants who elect not to use this app, paper self-monitoring records are provided.
15931917|NCT03404700|Behavioral|Egg breakfast|"Containing:2 Scrambled Eggs, 120 mL Skim Milk, 2 Slices Nature's Own Double Fiber Wheat Bread, 30g Margarine, 18g Smuckers Strawberry Jam
~10 g of Margarine, 18 g of Smuckers® Strawberry Jam"
15931918|NCT03404700|Behavioral|Egg breakfast with high saturated fat|Containing:2 Scrambled Eggs, 120 mL 2% milk, 2 Slices Nature's Own Double Fiber Wheat Bread, 15 g Butter, 15g Smuckers Strawberry Jam
15931919|NCT03404700|Behavioral|Cereal breakfast|Containing: 1c Special K ready-to-eat (RTE) High Protein Cereal, 200 mL Silk Original Soy milk, 1 Slice Mrs. Bairds Extra Thin Bread, 35g Margarine, 10 g Smuckers Sugar Free Strawberry Jam
15931920|NCT03404700|Behavioral|Cereal breakfast with high saturated fat|Containing: 1c Special K ready-to-eat (RTE) High Protein Cereal, 200 mL Silk Original Soy milk, 1/2 Slice Arnold Double Protein Whole Grain Bread, 15 g Butter
15931921|NCT03404687|Radiation|ultrasound|for assessment of adnexal masses size and pattern
15931922|NCT03404687|Diagnostic Test|cancer antigen 125 level|for prediction of malignancy
15931923|NCT03404687|Radiation|Doppler|for detection of blood flow
15931924|NCT03404674|Biological|CssBA|Recombinant enterotoxigenic Escherichia coli (ETEC) surface antigen 6 containing modified structural subunits A and B
15966299|NCT03140085|Biological|PYO Phage|Intravescial instillation
15931928|NCT03404648|Drug|Gadobutrol|Single dose of Gadavist® (Gadobutrol, Bayer) at no more than 0.1 mmol/kg will be administrated intravenously.
15931929|NCT03404648|Device|PET/MR scanner|C11-PET/MR and pelvic mpMRI scan for prostate cancer.
15931930|NCT03404635|Drug|Apixaban|Apixaban as standard of care for VTE
15931931|NCT03404635|Drug|Rivaroxaban|Rivaroxaban as standard of care for VTE
15931932|NCT03404622|Drug|IUCD|IUCD will be inserted in 100 women post placental removal and will be inserted in anther 100 women after six weeks post cesarean delivery
15931933|NCT03404609|Device|MagPro X100 by MagVenture|Participants received 5 consecutive days of accelerated cTBSmod to the right frontal pole. Each cTBSmod session was comprised of 1800 pulses, delivered in a continuous train of 600 bursts. Each burst contained 3 pulses at 30 Hz, repeated at 6 Hz. Ten sessions were applied per day (18,000 pulses/day, hourly) (90,000 total pulses) using a Magventure Magpro X100. Stimulation was delivered at 90% resting motor threshold (depth corrected). Localite Neuronavigation System was used to position the TMS coil over the individualized stimulation target.
15931934|NCT03404596|Drug|Nicotine Patch|Nicotine patches and thorough education of the indications for the patch will be provided to all participants.
15931935|NCT03404596|Behavioral|Counseling|Brief counseling sessions, 10-15 minutes each.
15931936|NCT03404596|Behavioral|Smartphone|Ecological momentary assessment (EMA) assesses participants' moment-to-moment subjective experiences via self-report assessments on a smart phone. Participants will receive mindfulness strategies for 10 days pre- and post-quit via smart phone to aid in their cessation attempt. Text messages will be sent to provided study phones throughout the day. These messages will be short (1-3 minutes long) and will ask participants to do things like focus on the present moment, pay attention to their breathing, and be aware of their current thoughts.
15931937|NCT03404596|Other|AutoSense|Participants will be asked to wear equipment throughout the day that will measure their physiology and smoking behavior. AutoSense unobtrusively and objectively collects physiological and behavioral data (i.e., negative affect (NA), self-regulatory capacity (SRC), and smoking) via wearable chest and wrist sensors.
15931938|NCT03404583|Behavioral|Person-centred care at distance through an eHealth platform|Person-centred care at distance through an eHealth platform, used by professionals, patients and relatives
15931939|NCT03404570|Drug|Dexmecamylamine HCl|Investigational drug
15931940|NCT03404570|Other|Placebo|Oral tablet containing no active drug.
15931941|NCT03404557|Other|Proteomic analysis|Proteomic analysis of Crohn's disease macrophages in response or not to Adherent-Invasive Escherichia coli
15931942|NCT03404544|Drug|Carbetocin bolus|Carbetocin 100 mcg intravenous as a bolus (less than 2 sec)
15931943|NCT03404544|Drug|Carbetocin infusion|Carbetocin 100 mcg intravenous as a 10 minutes infusion
15931944|NCT03404531|Behavioral|Social Media Messages Intervention Group|The Social Media Messages Intervention Group will receive theoretically-grounded messages through social media in order to encourage participants to regularly access the newly developed, culturally-tailored website that includes information about treatment as prevention and pre-exposure prophylaxis.
15931945|NCT03404531|Behavioral|Website Only Group|The Website Only group will have access to the newly developed, culturally-tailored website but will not receive social media messages.
15931946|NCT03404518|Drug|Norco|Hydrocodone/Acetaminophen as first line therapy every 6 hours as needed for pain control
15931947|NCT03404518|Drug|Ibuprofen|Ibuprofen as first line therapy every 6 hours as needed for pain control
15931948|NCT03404505|Behavioral|Infant Achievements|Play-based intervention for caregivers and infants. The efficacy of the Infant Achievements intervention for improving communication and social behavior in infants who are at risk for communication, social, or developmental delay.
15931949|NCT03404505|Behavioral|Caregiver Education (CE)|Parents in the CE group will be taught about child development and well-being in their home, weekly, with a weekly follow-up phone call by trained research staff.
15931950|NCT03404492|Other|Stress echocardiography|A stress echocardiography will be performed in addition to the traditional patient care
15931951|NCT03404479|Drug|Diacerein|For 12 weeks, administered twice a day by oral.
15931952|NCT03404479|Drug|Celecoxib|For 12 weeks, administered twice a day by oral.
15931953|NCT03404466|Drug|Hypidone Hydrochloride tablets|Hypidone Hydrochloride tablets 10 or 20mg/day Study drug is to be given orally, twice daily, for 6 weeks
15931954|NCT03404453|Diagnostic Test|Difficult airway incidence and prediction|Paediatric patients scheduled for surgery under general anaesthesia will be examined and a set up of airway prediction tests will be performed to predict the possibility of difficult airway
15931955|NCT03404440|Other|L.Reuteri|
15931956|NCT03404427|Behavioral|Normal sleep night|Usual hours of sleep
15931957|NCT03404427|Behavioral|Sleepless night|Total sleep deprivation the first night
15931958|NCT03404414|Drug|18F-FDG|"Single-dose 18F-FDG were injected into the patients before the PET/MR or PET/CT scans.
~patients before the PET/CT scans"
15931959|NCT03404401|Drug|BLI4700|Oral bowel preparation
15931960|NCT03404401|Drug|Polyethylene glycol bowel preparation|Oral bowel preparation
15931961|NCT03404388|Behavioral|Balance Training|4 days of a challenging balance training task
15931962|NCT03404375|Device|Gauss Triton system|"The Triton system (Gauss Surgical, Inc., Palo Alto, CA) is a novel mobile monitoring platform that combines mobile computing with Gauss Feature Extraction Technology (FET) to directly assess Hb mass (mHb) absorbed by surgical sponges from an image. The device is an iPad like imaging device that will assess blood loss via imaging of the surgical sponges used in the surgery.
~The device will be used to calculate blood loss on every patient enrolled in the study."
15931963|NCT03404362|Procedure|Bone Metastases Pain treatment|Comparative treatments to test if MRgFUS is an effective non-invasive and safe treatment for the palliation of metastatic bone tumors with a low incidence of co-morbidity as compared to EBRT (gold-standard)
15931997|NCT03404115|Drug|Reproxalap Ophthalmic Solution (0.1%)|Reproxalap Ophthalmic Solution (0.1%) administered for approximately twelve weeks.
15931998|NCT03404115|Drug|Vehicle Ophthalmic Solution|Vehicle Ophthalmic Solution administered for approximately twelve weeks.
15931999|NCT03404102|Device|Cu-IUD|Copper Intra-uterine device used as contraceptive method
15932000|NCT03404089|Device|pharmacokinetic device|MON4STRAT system: bed-side pharmacokinetic device for drug concentration measurement
15931964|NCT03404349|Behavioral|Mindfulness for Adolescence Course|There are 6 topics that will each be presented over 2 weeks for the 12 week intervention. Individuals will participate in a one to 1.5 hours, once a week intervention for 12weeks. Mindfulness is the practice of becoming aware of one's present-moment experience with compassion and openness as a basis for wise action. This curriculum is intended to strengthen attention and emotion regulation, cultivate wholesome emotions like gratitude and compassion, expand the repertoire of stress management skills, and help participants integrate mindfulness into daily life. Each lesson includes age-appropriate discussion, activities, and opportunities to practice mindfulness in a group setting.
15931965|NCT03404336|Behavioral|Well-Being Therapy|Session 1: identifying and setting episodes of wellbeing into situational context. Session 2: identifying interfering thoughts and behaviors. Session 3: illustrating autonomy, reflecting and practicing it. Session 4: illustrating environmental mastery, reflecting and practicing it. Session 5: illustrating positive relations with others, reflecting and practicing it. Session 6: illustrating personal growth, reflecting and practicing it. Session 7: illustrating self-acceptance, reflecting and practicing it. Session 8: illustrating purpose in life, reflecting and practicing it.
15931966|NCT03404336|Other|Control condition|Session 1: illustrating the concept of lifestyle and well-being. Session 2 and session 3: illustrating healthy eating and steps to healthy eating. Session 4: illustrating physical exercise and how it promotes health. Session 5: illustrating smoking and tobacco and how they can damage health. Session 6: illustrating alcohol and how it can damage health. Session 7: illustrating drugs misuse and how it can damage health. Session 8: illustrating sexual health. No access to specific WBT ingredients will be allowed.
15931967|NCT03404310|Dietary Supplement|Zinc Sulfate|Participant will take one 220mg tablet twice daily for three months.
15931968|NCT03404310|Other|Placebo (Gelatin Tablet)|Participant will take one tablet twice daily for three months.
15931969|NCT03404297|Other|Locally sourced compression therapy|The dressing is made up of a zinc oxide impregnated compression wrapping
15931970|NCT03404284|Behavioral|Family planning and infant immunization service integration|The approach involved integration of services through health surveillance assistant (HSA) outreach as well as through the health facility platform. The HSAs provided door to door FP services in their designated communities as well as provided integrated FP and Immunisation services at village clinics and outreach sessions. At outreach sessions, mothers were offered both routine infant immunization and family planning services (pills, condoms, injectables plus referrals for other methods). At health facilities, mothers who sought routine infant immunization services were offered same-day family planning services and those who seek family planning services are also screened for infant immunization schedule completion / need for infant immunization services. HSAs and health facility providers were trained on FP-immunization service integration and were monitored through regular supportive supervision visits.
15931971|NCT03404271|Dietary Supplement|Beta-hydroxy beta-methylbutyrate|3 grams per day of the calcium salt form of beta-hydroxy beta-methylbutyrate (HMB).
15931972|NCT03404271|Other|Resistance Training|Performing supervised resistance training three times per week.
15931973|NCT03404271|Dietary Supplement|Protein Supplementation|Consuming a protein supplement daily.
15931974|NCT03404271|Behavioral|Time-Restricted Feeding|Consuming all calories within a specified 8-hour period of time each day.
15931975|NCT03404258|Other|Research Blood Sampling|Blood samples will be collected at specified time points and research assays will be performed.
15931976|NCT03404245|Behavioral|Education, Fitbit/self-management app, physiotherapist counselling.|Participants will receive a brief education session, use a physical activity tracker Fitbit Flex paired with a self-management app, and remote counseling by a PT. Intervention will be received immediately.
15931977|NCT03404245|Behavioral|Same intervention with a 6 month delay|The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 6 month delay.
15931978|NCT03404232|Device|Dynesys DTO device (Zimmer Spine, Inc.)|All patients receive posterior hybrid instrumentation.
15931979|NCT03404219|Behavioral|Motivation and Skills Support (MASS)|Mobile phone-based application to support social skills and social motivation
15931980|NCT03404206|Drug|Naproxen Sodium (Aleve, BAY117031)|220 mg x 2 tablets, oral, single dose
15931981|NCT03404206|Drug|Ibuprofen (Advil)|200 mg x 2 tablets, oral, single dose
15931982|NCT03404206|Drug|Placebo|Matching placebo, 2 tablets, oral, single dose
15931983|NCT03404193|Drug|Decitabine|Given IV
15931984|NCT03404193|Other|Laboratory Biomarker Analysis|Correlative studies
15931985|NCT03404193|Drug|Venetoclax|Given PO
15931986|NCT03404180|Procedure|Peripheral nerve block|All enrollees will have ultrasound-guided femoral and sciatic nerve blocks placed per current practice at research site. Single-injection obturator and lateral femoral cutaneous nerve blocks will also be performed.
15931987|NCT03404180|Drug|Intravenous Sedatives|Intravenous sedation using propofol or dexmedetomidine will be administered.
15931988|NCT03404180|Procedure|Lateral femoral cutaneous nerve blocks|After administration of intravenous sedation, lateral femoral cutaneous and obturator nerve blocks (in addition to the femoral and sciatic catheters) will be performed under ultrasound guidance.
15931989|NCT03404180|Procedure|Obturator nerve blocks|After administration of intravenous sedation, lateral femoral cutaneous and obturator nerve blocks (in addition to the femoral and sciatic catheters) will be performed under ultrasound guidance.
15931990|NCT03404167|Drug|AZD0914|Zoliflodacin (also known as AZD0914 and ETX0914), is a spiropyrimidinetrione antibacterial agent
15931991|NCT03404154|Diagnostic Test|3D ultrasound|it describes the diagnostic test which is 3D us to diagnose the cause of postmenopausal bleeding
15931992|NCT03404154|Procedure|Dilatation and curretage|it describes the surgical maneuver that will be made to diagnose cause of bleeding
15931993|NCT03404141|Other|Parent craft|Midwife-guided classes for pregnant women about pregnancy and childbirth
15931994|NCT03404141|Behavioral|Cognitive-Behavioral Therapy|Cognitive-Behavioral Therapy to reduce stress levels among pregnant women
15931995|NCT03404128|Other|Questionnaires|Questionnaire for patient: satisfaction regarding rechargeable DBS battery Questionnaire for neurologist: seizure frequency, satisfaction regarding rechargeable DBS battery
15931996|NCT03404115|Drug|Reproxalap Ophthalmic Solution (0.25%)|Reproxalap Ophthalmic Solution (0.25%) administered for approximately twelve weeks.
15966300|NCT03140085|Drug|Antibiotics|Oral application
15932001|NCT03404089|Device|pharmacokinetic device|High performance liquid chromatography, (HPLC), the reference methods HLPC tandem mass spectrometry or Ultraviolet are using
15932002|NCT03404076|Diagnostic Test|Dual Energy CT|Dual Energy CT is performed for diagnostic evaluation in gastrointestinal stromal tumor (GIST) patients undergoing tyrosine kinase inhibitor (TKI) treatment
15932003|NCT03404063|Drug|Cardiac Drug|"Patients in the AMI trial will receive one dose of IMP during the index procedure. The IMP administration will be performed by dedicated catheter into infarct related artery.
~Active IMP consist of 30 000 000 of Wharton's jelly mesenchymal stem cells (WJMSCs) in each IMP dose prepared for patients randomized into active treatment group."
15932004|NCT03404063|Drug|Placebos|"Patients randomized to the control group will receive 0.9% NaCl and 5% albumin injections (in the same volume as CardioCell) in the same manner.
~Control group will receive the same amount of fluid used for WJMSCs preparation, without cells."
15932005|NCT03404050|Other|Music and dance movement therapy|Theoretically, the intervention adopts a humanistic approach of person centred care highlighting the importance of maintaining and enhancing personhood for older people with dementia.
15932006|NCT03404037|Diagnostic Test|serum endostatin level|"An oral (metoprolol 20 mg) was given to the patients with heart rates > 60 beats/minute and had no contraindications to beta-blockers, one hour before the scan. Sublingual nitroglycerin was given to all patients before CT examination. A 64-slice CT scanner (Sensation 64; Siemens Medical System, Germany) was used for imaging all subjects. All CT examinations were done during inspiratory breath holding.
~Endostatin levels were measured using a sandwich ELISA kit according to the manufacturer's instructions endostatin ELISA kit (R&D Systems, Minneapolis, Minnesota, USA"
15932007|NCT03404024|Biological|Stage 1-Low dose VM202RY|Day 0: 1mg of VM202RY (4 sites of 0.25mg/0.5mL VM202RY)
15932008|NCT03404024|Biological|Stage 1-Middle dose VM202RY|Day 0: 2mg of VM202RY (8 sites of 0.25mg/0.5mL VM202RY)
15932009|NCT03404024|Biological|Stage 1-High dose VM202RY|Day 0: 3mg of VM202RY (12 sites of 0.25mg/0.5mL VM202RY)
15932010|NCT03404024|Drug|Stage 2-Placebo|Day 0: 6mL of VM202RY vehicle (12 sites of 0.5mL 1.1% sucrose/0.9% NaCl)
15932011|NCT03404024|Biological|Stage 2-Low dose VM202RY|Day 0: 6mL of VM202RY and VM202RY vehicle (total 12 site injections, low dose candidate-0.5mg VM202RY, 1mg VM202RY, 1.5mg VM202RY)
15932012|NCT03404024|Biological|Stage 2-High dose VM202RY|Day 0: 6mL of VM202RY and VM202RY vehicle (total 12 site injections, high dose candidate-1mg VM202RY, 2mg VM202RY, 3mg VM202RY)
15932013|NCT03404024|Device|C-Cathez® Catheter|Day 0 (Stage 1-Low dose VM202RY): 1mg of VM202RY (4 sites of 0.25mg/0.5mL VM202RY) Day 0 (Stage 1-Middle dose VM202RY): 2mg of VM202RY (8 sites of 0.25mg/0.5mL VM202RY) Day 0 (Stage 1-High dose VM202RY): 3mg of VM202RY (12 sites of 0.25mg/0.5mL VM202RY) Day 0 (Stage 2-Placebo): 6mL of VM202RY vehicle (12 sites of 0.5mL 1.1% sucrose/0.9% NaCl) Day 0 (Stage 2-Low dose VM202RY): 6mL of VM202RY and VM202RY vehicle (total 12 site injections, low dose candidate-0.5mg VM202RY, 1mg VM202RY, 1.5mg VM202RY) Day 0 (Stage 2-High dose VM202RY): 6mL of VM202RY and VM202RY vehicle (total 12 site injections, high dose candidate-1mg VM202RY, 2mg VM202RY, 3mg VM202RY)
15932014|NCT03404011|Other|Propylene glycol and Glycerol intake|Intake of 1 gram of propylene glycol/Glycerol mix (50:50). Blood sample before, 5 minutes and 20 minutes after intake.
15932015|NCT03404011|Device|Mimicking intake|Mimicking propylene glycol/glycerol intake with the device turns off. Blood sample before, 5 minutes and 20 minutes after intake.
15932016|NCT03403998|Other|Exercises|The treatment will consist of an 8-week progressive exercise program of neck flexors and extensors exercises supervised by a physical therapist for 30-45 min twice a week per 8 weeks as described in Arm/group descriptions.
15932017|NCT03403998|Other|Placebo|The placebo treatment will be for 30-45 min twice a week for 8 weeks, as for the intervention group. ( see details in arm description)
15932018|NCT03403985|Drug|Calcium Hydroxide (Ca(OH)2)|Ca(OH)2 will be used in this group
15932019|NCT03403985|Drug|Mineral Trioxide Aggregate|MTA will be used in this group
15932020|NCT03403972|Drug|Vancomycin 250Mg Capsule|Investigators will compare simavastatin pharmacokinetics before and after the vancomycin PO multiple administration.
15932021|NCT03403959|Device|light therapy|6 weeks morning treatment with bright light therapy in own home.
15932022|NCT03403946|Device|Macintosh blade|Laryngoscopy with C-MAC PM in combination with Macintosh blade
15932023|NCT03403946|Device|D-Blade|Laryngoscopy with C-MAC PM in combination with D-Blade
15932024|NCT03403946|Device|Intubation|Intubation with C-MAC PM in combination with D-Blade
15932025|NCT03403933|Drug|Didrogyl|"Calcifediol will be administered at a dose of 10 drops per day (as indicated for use) for 6 months or until vitamin D levels> 30 ng / ml are obtained.
~Once these values have been obtained, the dosage can be reduced to a dosage of 4/5 drops of calcifediol (1 drop contains 5mcg of calcifediol) with the aim to maintain the plasma values of 25 (OH) D in a optimal range between 30-60 ng / ml during the 6 month of the duration of the study."
15932026|NCT03403920|Other|Questionnaire|Profile Fitness Mapping Low Back Questionnaire
15932027|NCT03403907|Other|Probiotic|twice a day for 4 months (Streptococcus thermophilus, Lactobacillus acidophilus, L.plantarum, L. paracasei, L. delbrueckii subs bulgaricus, Bifidobacterium breve, B.longus y B.infantis. y CD2).
15932028|NCT03403894|Behavioral|Asking caregivers in their practice|A questionary is given to caregivers
15932029|NCT03403881|Behavioral|Physical activity promotion + TAU|"Pedometer:
~Each patient will receive a pedometer with increasing weekly aims on number of steps during the trial.
~The number of steps to be achieved starts on 4.000 and increases progressively until the end of the trial.
~Behavioral strategy based on STD theory, and the assessment of barriers and facilitators of each patient.
~All patients were receiving treatment as usual"
15932030|NCT03403881|Behavioral|Control|Weekly call on general health aspects + treatment as usual
15932031|NCT03403868|Diagnostic Test|conductance catheter|pressure volume loops are assessed via a special catheter (Conductance catheter)
15932032|NCT03403855|Device|Rocket® IPC- Long External Length|Rocket® IPC- Long External Length Intervention. Evaluation of Long and Short External Length Rocket® Pleural Catheters in Terms of Quality of Life, Feasibility and Satisfaction in Patients Being Treated for Recurrent Malignant Pleural Effusions
15932033|NCT03403855|Device|Rocket® IPC- Short External Length|Rocket® IPC- Short External Length Intervention. Evaluation of Long and Short External Length Rocket® Pleural Catheters in Terms of Quality of Life, Feasibility and Satisfaction in Patients Being Treated for Recurrent Malignant Pleural Effusions
15932035|NCT03403842|Device|Peridural catheter|Positioning of a peridural catheter with a continuous infusion of ropivacaine 0,2% 99 ml+sufentanil 50 mcg
15932036|NCT03403842|Drug|PCA Morphine|Administration of endovenous morphine with a PCA
15932037|NCT03403829|Drug|Gemcitabine|Gemcitabine maintenance chemotherapy
15932038|NCT03403829|Radiation|standard chemoradiotherapy|standard chemoradiotherapy
15932039|NCT03403816|Behavioral|Before School Physical Activity Program|BOKS is a before school physical activity program offered at no cost to participating families that focuses on engaging elementary and middle school students in physical activity, skill development and brief nutrition education sessions that prepare them for a day of learning. The BOKS curriculum includes 12 weeks of instruction and 40 minutes of structured kid-friendly activities that include warm-ups, skill of the week, running, relay and obstacle course activities and nutritional tips. The BOKS team provides training for BOKS leaders free of charge each month. BOKS is currently being used in more than 1,800 schools in the US and Canada.
15932040|NCT03403803|Device|Optune|"Optune is a wearable and portable, FDA-approved device that has been shown in clinical trials to safely deliver continuous therapy to the area of your brain where your GBM (Glioblastoma) tumor is located.
~TMZ (Temozolomide) is an oral chemotherapy drug. It is an alkylating agent used as a treatment of some brain cancers; as a second-line treatment for astrocytoma and a first-line treatment for glioblastoma multiforme."
15932041|NCT03403790|Drug|Quetiapine|Oral (extended-release tablet)
15932042|NCT03403777|Drug|Avelumab|AVELUMAB will be administered intravenously 10mg/kg every 2 weeks.
15932043|NCT03403764|Other|Wellness Intention|
15932044|NCT03403751|Drug|Reltecimod 0.5 mg/kg|Single IV infusion of 0.5 mg/kg Reltecimod (at a concentration of 1 mg/mL) over approximately 10 minutes
15932045|NCT03403751|Drug|Placebo|Single IV infusion of 0.5 mL/kg of 0.9% saline (volume equivalent to Reltecimod dosing schema) over approximately 10 minutes
15932046|NCT03403738|Behavioral|Bounce Back Now|web/smartphone-based intervention for disaster victims
15932047|NCT03403738|Behavioral|enhanced usual care|enhanced usual care with list of resources
15932048|NCT03403725|Drug|MEN1309|MEN1309 solution for intravenous infusion once every 3 weeks
15932049|NCT03403712|Drug|fosnetupitant/ palonosetron|intravenous fosnetupitant/ palonosetron (260 mg/0.25 mg) fixed-dose combination
15932050|NCT03403712|Drug|netupitant/palonosetron|oral netupitant/palonosetron (300 mg/0.50 mg) fixed-dose combination
15932051|NCT03403712|Drug|dexamethasone|Oral dexamethasone (12 mg)
15932052|NCT03403699|Biological|Generation of inducible pluripotent stem cells|Generation of inducible pluripotent stem cells from peripheral blood cells.
15932053|NCT03403686|Biological|blood draw|Blood sample will be obtained and CD34+ cells will be isolated for functional testing.
15932054|NCT03403673|Other|Frailty assessment tools|There is evidence to suggest that patients who are frail have a higher risk of developing complications after major surgery. Our aim is to ask you simple questions about your physical ability to perform daily life activities, assess your general health condition and ask you to do simple tasks such as drawing a clock or walking for a short distance to assess your speed of walking. Our main aim is to identify a tool that will assist us to identify patients who are at risk of frailty
15932055|NCT03403660|Other|non White coat|Postpartum patients are randomized to either arm of the study (white coat or standard scrub suit only) by location. All the obstetric physicians associated with patient's postpartum care should use or not use white coat in every single encounter with patient.
15932056|NCT03403647|Dietary Supplement|Vitamin D|Oral daily vitamin D
15932063|NCT03403595|Drug|177Lu-EB-PSMA-617|accepted intravenous injection of 177Lu-EB-PSMA-617 and monitored at 2, 24, 72, 120 and 168 hours post-injection.
15932064|NCT03403582|Other|Raspberries|250g frozen whole red raspberries
15932065|NCT03403569|Drug|Triptolide Wilfordii|In addition to appropriate ART, Triptolide Wilfordii will be given to patients in the experimental group at a dosage of 20mg three times a day per os for 12 months.
15932066|NCT03403569|Drug|Placebo Oral Tablet|In addition to appropriate ART, placebo oral tablets will be given to patients in the experimental group at a dosage of 2 pills three times a day per os for 12 months.
15932067|NCT03403556|Drug|Rosuvamibe|Rosuvastatin 10mg/Ezetimibe10mg qd for 24 weeks
15932068|NCT03403556|Drug|Monorova|Rosuvastatin 20mg qd for 24 weeks
15932069|NCT03403530|Drug|IgM rich Immunoglobin|the 'IgM rich immunoglobn' is the normal human immunoglobin containing Human plasma protein 50mg/ml of which immunoglobin is atleast 95% Immunoglobin M (IgM) 6mg Immunoglobin A (IgA) 6mg Immunoglobin G (IgG) 38mg
15932070|NCT03403517|Drug|Methylprednisolone|10 mg/kg methylprednisolone mixed in 100 ml NaCl (sodium chloride), infusion over 30 minutes, prior to surgery
15932071|NCT03403517|Drug|Dexamethasone|Dexamethasone mixed in 100 ml NaCl, infusion over 30 minutes, prior to surgery
15932072|NCT03403504|Drug|Oxycodone Tamper Resistant|Orally administered Oxycodone Tamper Resistant 10mg
15932073|NCT03403504|Drug|OXYCONTIN®|Orally administered OXYCONTIN® Tablet 10 mg
15932074|NCT03403491|Other|patientMpower application|electronic health journal for patient to record weight, blood pressure, medication adherence and symptoms
15932075|NCT03403491|Other|sham application|dummy application which does not allow recording of weight, blood pressure, medication adherence and symptoms
15932076|NCT03403478|Other|LICE|No specific exercise will be performed. The participant will walk into the pool accompanied with a researcher for 45 minutes.
15932077|NCT03403478|Other|MICE|"The following exercises will be carried out: a) jumping jacks (shoulder abduction and adduction); b) horizontal adduction and abduction of the shoulder; c) stationary running with knee elevation; d) pull and push horizontally with upper limbs; e) pull and push vertically with upper limbs.
~Note: For exercises 'a' and 'b', the legs alternated in movements in the sagittal plane to provide greater stability to the participant's movement. For exercises 'd' and 'e', the legs simulates a stationary running."
15932078|NCT03403478|Other|HIIE|"The following exercises will be carried out: a) jumping jacks (shoulder abduction and adduction); b) horizontal adduction and abduction of the shoulder; c) stationary running with knee elevation; d) pull and push horizontally with upper limbs; e) pull and push vertically with upper limbs.
~Note: For exercises 'a' and 'b', the legs alternated in movements in the sagittal plane to provide greater stability to the participant's movement. For exercises 'd' and 'e', the legs simulates a stationary running."
15932079|NCT03403478|Other|Aquatic exercise training|"The sessions of the aquatic exercise training will be divided into 3 phases: warm-up (10 minutes), main part (40 minutes) and cool down.
~In order to increase intensity to aquatic exercise, the training program will carried out as follows:
~From week 1 to 4 the instructors will use a 128 bpm musics in both warm-up and cool down. In main part, will be used a 130 bmp musics.
~From week 5 to 8 the instructors will use a 130 bpm musics in both warm-up and cool down. In main part, will be used a 132 bmp musics.
~From week 9 to 12 the instructors will use a 132 bpm musics in both warm-up and cool down. In main part, will be used a 135 bmp musics."
15932080|NCT03403465|Other|FDG PET scan|At radiation planning subjects will have a PET-CT. The CT scan - also called computerized tomography or just CT - combines a series of X-ray views taken from many different angles to produce cross-sectional images of the bones and soft tissues inside the body. CT scans in planning radiation therapy are standard of care. A PET is a highly specialized imaging technique that uses short-lived radioactive substances (such as FDG a simple sugar labeled with a radioactive atom) to produce three-dimensional colored images of those substances functioning within the body. These images are called PET scans and the technique is termed PET scanning. PET scanning provides information about the body's chemistry not available through other procedures. Unlike CT or MRI (magnetic resonance imaging), techniques that look at anatomy or body form, PET studies metabolic activity or body function.
15932081|NCT03403452|Drug|Apatinib|500 mg,p.o.,qd, until disease progression or intolerable toxicity or patients withdrawal of consent.
15932082|NCT03403439|Drug|BI 1015550|Reference and Test Treatment
15932083|NCT03403439|Drug|itraconazole|Test treatment
15932084|NCT03403426|Device|Wingman Crossing Catheter|Endovascular CTO crossing
15932085|NCT03403413|Device|muscle vibration during walking|Baseline assessment of gait followed by 12 sessions (3/week for a month) of gait training with cyclic muscle vibration during walking emulating normal muscle activity of lower extremities in treatment group. Gait assessment both with and without muscle vibration were collected at follow-up after 12 sessions of gait training with muscle vibration.
15932086|NCT03403400|Behavioral|VRWP Group|The VRWP group will have VR with an instruction to increase their number of steps daily to at least 3,000 steps using the pedometer (VR plus walking plus pedometer group). They will receive pedometers (Fitbit Zip), instructions on how to use the pedometer, step log forms, with home instruction handout to walk more at least more than ten minutes at a time. The participants will record on their activity log the number of steps shown on the step display at the end of the day. The daily step log form will be given to the research staff every visit for recording. The research staff will encourage their participants to increase their daily steps at least 10% until they achieve at least 3,000 steps daily.
15932087|NCT03403400|Behavioral|VRW Group|The VR (control) group will follow the conventional VR physical therapy without the encouragement of walking and without specification of walking in the home exercise program.
15932088|NCT03403387|Dietary Supplement|GlutenShield|combination probiotic, prebiotic, and enzyme supplement
15932089|NCT03403387|Other|Placebo|Avicel (cellulose) and bentonite powder
15932090|NCT03403374|Drug|evolocumab|Administered by SC injection via autoinjector (AI)/pen
15932091|NCT03403361|Device|Siemens Somatom Definition Edge|In addition to acquiring medically-routine datasets, each patient subject will be scanned sequentially at two or three different beam energies (80 or 90 kVp, 100 kVp, 120 kVp, and 140 kVp) as part of this research study. These additional scans will be acquired utilizing the FDA-approved workflow and scanner operating modes. Sinogram data will be exported in raw, minimally processed form utilizing proprietary data export and processing tools provided to the investigators by the scanner vendors. In no case, will the additional local imaging dose (in terms of CTDIvol) given to the patients by the two or three additional scans exceed 6 cGy per session
15932092|NCT03403361|Device|Philips Brilliance Big Bore CT/simulator|In addition to acquiring medically-routine datasets, each patient subject will be scanned sequentially at two or three different beam energies (80 or 90 kVp, 100 kVp, 120 kVp, and 140 kVp) as part of this research study. These additional scans will be acquired utilizing the FDA-approved workflow and scanner operating modes. Sinogram data will be exported in raw, minimally processed form utilizing proprietary data export and processing tools provided to the investigators by the scanner vendors. In no case, will the additional local imaging dose (in terms of CTDIvol) given to the patients by the two or three additional scans exceed 6 cGy per session
15932093|NCT03403348|Drug|JNJ-64417184|Participants will receive JNJ-64417184 in Parts 1, 2A, 2B, 3, 4, 5 and 6.
15932094|NCT03403348|Drug|Placebo|Participants will receive matching placebo to JNJ-64417184 in Parts 1, 2A, 2B, 3, 4, 5 and 6.
15932095|NCT03403335|Behavioral|Mindfulness Based Practices for Health Care Professionals in Training|Eight weekly sessions including didactic lecture, discussion, homework, gentle yoga, and meditation and mindfulness exercises
15932096|NCT03403322|Other|Kinesio taping|An experienced physiotherapist placed the base of the Kinesio taping strip, over rectus femoris muscle, 3cm bellow the anterior iliac spine, without tension. From this point, the Kinesio taping was placed up to the upper edge of the patella and stretched to 100% tension. It was, then, bi-sectioned, circled the patella and ended in the tuberosity of the femur, without tension. In order to avoid interference in the electromyography signals, a section was held at Kinesio taping at the point where the electrode was placed.
15932097|NCT03403322|Other|Without taping|Children performed functional activities without tape
15932098|NCT03403309|Drug|1) Inosine 5'-monophosphate|1) Subjects are initiated with 1 tablet (500mg of inosine 5'-monophosphate per one tablet) two times per day, and then titrated up by 1 tablet per every visit up to visit 2, i.e. increased up to 2 tablets two times a day by week 6. A maximum limit of elevated serum uric acid level is 9 mg/dL, so that reducing dose of administration may be considered in case of being way over the top of limited level.
15932099|NCT03403309|Drug|Placebo|2) Subjects are initiated with 1 tablet (500mg of placebo tablet with inactive therapeutic effect) two times a day, and then titrated up by 1 tablet per every visit up to visit 2, i.e. increased up to 2 tablets two times a day by week 6. A maximum limit of elevated serum uric acid level is 9 mg/dL.
15932101|NCT03403283|Other|15 subjects with Non Proliferative Diabetic Retinopathy(mild, moderate and severe). 15 subjects with Proliferative Diabetic Retinopathy|
15932102|NCT03403283|Other|Healthy Controls 15 age matched control subjects|
15932103|NCT03403270|Other|ENCOURAGE App|Users will have an opportunity to engage with the app as described for the duration of the study period.
15932104|NCT03403257|Other|No interventions|No intervention
15932105|NCT03403244|Procedure|US-MR image fusion-guided PTED|patients diagnosed with lumbar disc herniation undergoing US-MR image fusion-guided PTED
15932106|NCT03403244|Procedure|fluoroscopy-guided PTED|patients diagnosed with lumbar disc herniation undergoing fluoroscopy-guided PTED
15932107|NCT03403231|Behavioral|INVENT Secure Messaging Intervention|We are proposing a 12 week schedule of weekly Secure Messages and monthly mailings for this intervention. Each study arm represents different combinations of messages a participant will receive.
15932108|NCT03403218|Behavioral|Case group|assessment of quality on posture, transfers and displacement
15932109|NCT03403205|Drug|ALXN1840|ALXN1840 administered orally in 15 mg tablets
15932110|NCT03403205|Drug|SoC Therapy|Depending on the site/region, participants randomized to receive SoC treatment will receive trientine, penicillamine, Zinc, or a combination of these medicines, administered according to standard regimens.
15932111|NCT03403192|Device|EZ-Blocker|"The EZ-Blocker essentially functions as a bronchial blocker with a 7-Fr shaft with two separate occlusive balloons coming off this shaft in a Y configuration designed to rest on the carina. Once anchored in place the operator can choose to inflate one of the two occlusive balloons to isolate one main stem bronchus or the other. According to the manufactures recommendations the EZ-blocker is placed through a Y-piece adaptor included with the blocker kit. A flexible fiberoptic bronchoscope (FFB) is placed in a separate limb of this Y-piece and this fed through along side the EZ-blocker to visualize and confirm placement of the of the BB. The balloon is then inflated typically under direct vision to occlude that bronchus thus isolating that lung hopefully achieving full lung isolation."
15932112|NCT03403192|Device|DLT|A Double Lumen Tube (DLT) is made of two small-lumen endotracheal tubes of unequal length fixed side by side. The shorter tube ends in the trachea while the longer tube is placed in either the right or left bronchus to ventilate the right or left lung.
15932113|NCT03403179|Other|Functional Remediation|Functional Remediation: The functional remediation program consists of 21 weekly sessions, each lasting 90 min. This intervention addresses neurocognitive issues such as attention, memory and executive functions, but it focuses even more on enhancing functioning in daily routine. The content of the intervention is based on ecological tasks to be performed in two settings, in the clinic as well as at home. Participants will be trained with exercises for memory, attention, problem solving and reasoning, multitasking and organization in order to improve their functional outcome. Most of the techniques are based on paper-and-pencil tasks and group activities.
15932114|NCT03403166|Behavioral|DASH diet|Diet intervention
15932115|NCT03403166|Behavioral|Fruits and vegetables diet|Diet intervention
15932116|NCT03403166|Behavioral|Control diet|Diet intervention
15932117|NCT03403153|Behavioral|SAHP|"Aim 1: To obtain and incorporate expert clinician and Veteran feedback on credibility, acceptability, and satisfaction with the intervention to ensure Veteran-friendly intervention manual, materials, and processes. Aim 1 will be accomplished through two rounds of expert panel review of treatment/MIA manual and two rounds of pilot testing of the treatment for Veteran Feedback in 16 female and 16 male Veterans.
~Aim 2: To evaluate feasibility of study recruitment, retention, assessment procedures and proposed methods of the intervention. Preliminary examination of whether the intervention results in improvements to parenting behaviors, parenting satisfaction and overall family functioning."
15932118|NCT03403140|Drug|Etanercept|"Enerceptan®. Injectable Solution in prefilled syringes
~Source: GEMABIOTECH S. A. Formulation per unit:
~1,0 ml of Enerceptan® contains 50 mg solution of Etanercept /Once a week Methotrexate 15 to 25 mg / Once a week"
15932119|NCT03403127|Diagnostic Test|PET/CT Scans|PET Imaging requires the use of an investigational drug, a radioactively-labelled sugar called 18F-Fluorodeoxyglucose (FDG). FDG is glucose labelled with a radioactive fluorine atom. It is given by intravenous injection and is particularly absorbed by cancer cells. The radioactive signal given off by the FDG can then be detected by the PET scanner providing an image of the cancer (or tumour).
15932120|NCT03403114|Behavioral|Questionnaire|a 15min questionnaire
15932121|NCT03403101|Drug|S1|"Patients are planned to receive the SIRIOX regimen including S-1 (BSA < 1.2m2, 40 mg/day; BSA = 1.2~1.4 m2, 60 mg/day; BSA = 1.4~1.6 m2, 80 mg/day; BSA > 1.6 m2, 100 mg/day; oral twice daily on days 1-7, days 15-21）of every cycle.
~• 28 days a cycle."
15932122|NCT03403101|Drug|Oxaliplatin|"Patients are planned to receive the SIRIOX regimen including Oxaliplatin (OXA, 85 mg/m2; d1,d15) of every cycle.
~• 28 days a cycle"
15932123|NCT03403101|Drug|Irinotecan|"Patients are planned to receive the SIRIOX regimen including Irinotecan (IRI, 180mg/m2; day 1,day 15) of every cycle.
~• 28 days a cycle"
15932124|NCT03403088|Device|Experimental: • Group LA|to apply Laser (780 nm and 70mW) at the cementum-enamel junction fat the teeth affected by sensitivity
15932125|NCT03403088|Device|Placebo Comparator: • Group LA-P|to apply Laser (780 nm and 70mW) at the cementum-enamel junction at the teeth affected by sensitivity with the laser device having no effective laser emission, only guided by light
15932126|NCT03403088|Other|Experimental: • Group DE|to brush teeth with a blinded dentifrice with 0,45% of stannous fluoride and a soft-bristled manual toothbrush (Johnson & Johnson®).
15932127|NCT03403088|Other|Placebo Comparator: • Group DE-P|to brush teeth with a blinded dentifrice with 1500 ppm of available fluoride and a soft-bristled manual toothbrush (Johnson & Johnson®).
15932128|NCT03403088|Other|Experimental: • Group RGI|to apply a thin layer of resin based glass-ionomer product on the cervical surface of the affected teeth affected by sensitivity following the manufacturer instructions.
15932129|NCT03403088|Other|Experimental: Group RX|to apply Adper Single Bond Plus Adhesive in accordance with the manufacturer instructions, at the teeth affected by sensitivity product for 20 seconds.
15932130|NCT03403075|Behavioral|ETAF|Therapeutic education and Physical activity
15932131|NCT03403075|Behavioral|Usual care|Usual care
15932132|NCT03403049|Radiation|Carbon Ion|Study subjects will receive carbon ion radiotherapy (CIRT), with daily fraction sizes of 3 GyE. The total CIRT dose will increase with each dose level. Subjects in dose level 1 and 2 will receive photon radiotherapy as well.
15932133|NCT03403049|Drug|Gemcitabine + Cisplatin|"Combined chemotherapy regimen before/after radiotherapy: gemcitabine-based chemotherapy regimen.
~All patients will have received 2-4 cycles of gemcitabine-based chemotherapy prior to study registration, with post-chemotherapy imaging demonstrating locally-advanced disease without evidence of distant metastatic disease spread. Patients who received chemotherapy regimens other than those listed above may be considered for study enrollment at the discretion of the lead investigators, provided that all other eligibility criteria are satisfied. Gemcitabine-based chemotherapy will be continued starting 3-5 weeks after completion of radiotherapy until disease progression, intolerability, or the patient's decline of chemotherapy."
15932134|NCT03403049|Drug|Gemcitabine + Capecitabine|"Combined chemotherapy regimen before/after radiotherapy: gemcitabine-based chemotherapy regimen.
~All patients will have received 2-4 cycles of gemcitabine-based chemotherapy prior to study registration, with post-chemotherapy imaging demonstrating locally-advanced disease without evidence of distant metastatic disease spread. Patients who received chemotherapy regimens other than those listed above may be considered for study enrollment at the discretion of the lead investigators, provided that all other eligibility criteria are satisfied. Gemcitabine-based chemotherapy will be continued starting 3-5 weeks after completion of radiotherapy until disease progression, intolerability, or the patient's decline of chemotherapy."
15932135|NCT03403049|Drug|Gemcitabine + Erlotinib|"Combined chemotherapy regimen before/after radiotherapy: gemcitabine-based chemotherapy regimen.
~All patients will have received 2-4 cycles of gemcitabine-based chemotherapy prior to study registration, with post-chemotherapy imaging demonstrating locally-advanced disease without evidence of distant metastatic disease spread. Patients who received chemotherapy regimens other than those listed above may be considered for study enrollment at the discretion of the lead investigators, provided that all other eligibility criteria are satisfied. Gemcitabine-based chemotherapy will be continued starting 3-5 weeks after completion of radiotherapy until disease progression, intolerability, or the patient's decline of chemotherapy."
15932136|NCT03403049|Drug|Gemcitabine|"Combined chemotherapy regimen before/after radiotherapy: gemcitabine-based chemotherapy regimen.
~All patients will have received 2-4 cycles of gemcitabine-based chemotherapy prior to study registration, with post-chemotherapy imaging demonstrating locally-advanced disease without evidence of distant metastatic disease spread. Patients who received chemotherapy regimens other than those listed above may be considered for study enrollment at the discretion of the lead investigators, provided that all other eligibility criteria are satisfied. Gemcitabine-based chemotherapy will be continued starting 3-5 weeks after completion of radiotherapy until disease progression, intolerability, or the patient's decline of chemotherapy."
15932137|NCT03403049|Radiation|Photon|During this study, the prescribed dose shall be administered according to the dose escalation shown in the table, starting with dose level 1. The carbon ion dose shall be gradually escalated while gradually reducing the dose of photons until eventually administering a full dose of 56 GyE/14 Fx carbon ions (fractional dose of 4 GyE). Dose escalation will be performed in parallel for two patient groups: patients whose pancreatic tumors are greater than 5 mm from the duodenum (Group A) and those whose tumors are within 5 mm of the duodenum (Group B). Enrolled patients will be monitored for 90 days after radiotherapy starts for any acute toxic reaction and to explore the maximum tolerated dose, in addition to being observed for any related long-term toxic reactions in accordance with the protocol.
15932138|NCT03403036|Drug|Brodalumab|Weeks 0, 1, 2, and every 2 weeks thereafter through and including Week 16.
15932139|NCT03403023|Device|Tear Film Imager|The TFI is an imaging device based on standard camera that uses white light to image the tear film in an ultra high resolution. DES patients in this study will be imaged before and 3 months after initiation of treatment with Restasis (the treatment indicated for their condition).
15932140|NCT03403023|Drug|Restasis|Restasis therapy is given to all of the patients as indicated for moderate-severe DES. TFI imaging is performed before and 3 months after initiation of therapy.
15932141|NCT03403010|Other|Rehabilitation-specific gaming platform|The rehabilitation specific gaming software was developed as part of the ICT4rehab project with partners from the Vrije Universiteit Brussel and the University Libre de Bruxelles. The ICT4Rehab puts several ICT tools supporting 2/3D user interaction into place. The games can be controlled using a Kinect camera system (Microsoft(®) (Redmond, WA) Kinect™) or a Wii balance board (® NintendoTM, Japan), depending on the choice of the therapist and the needs of the child.
15932142|NCT03402997|Diagnostic Test|Resistivity measurement|To measure and compare the tissue impedance values obtained by analysing ex vivo non-neoplastic (healthy and peritumoral) and neoplastic breast tissues
15932143|NCT03402984|Drug|Acotiamide|Acotiamide treatment, 100 mg, t.i.d. for three week. Intake 10 minutes before meal.
15932144|NCT03402984|Drug|Placebo Oral Tablet|Placebo treatment, t.i.d. for three week. Intake 10 minutes before meal.
15932145|NCT03402971|Diagnostic Test|echocardiography|echocardiography focused on right heart: Parameters include RV enddiastolic diameter basal, mid-cavity and longitudinal, RVOT distal, pulmonal outflow AT and AT/ET, endsystolic RA area. RV wall thickness, TAPSE, S', tricuspidal E/A, E/e', RIMP. V. Cava to estimate CVP and sPAP.
15932146|NCT03402945|Device|Prevena|Negative-Pressure Wound Management System
15932147|NCT03402945|Drug|Cefazolin|antibiotic
15932148|NCT03402945|Drug|Vancomycin|antibiotic
15932149|NCT03402945|Other|standard wound dressing|Any non-negative pressure wound dressing that is routinely used at study sites will be considered standard of care in the control arms.
15932150|NCT03402932|Other|Auditory amplified|The cognitive test will be administered using a computer-based signal processing to amplify the instruction. The presentation level is customized to the individual's hearing thresholds.
15932151|NCT03402932|Other|Visual|The cognitive test will be administered visually by using timed computer slides.
15932152|NCT03402932|Other|Auditory unamplified|The cognitive test will be administered by using a generic presentation level that simulates a normal conversational level.
15932153|NCT03402906|Behavioral|Family-Clinician Collaboration Program|Family-mediated treatment activities and collaboration between clinician and family members
15932154|NCT03402906|Behavioral|Standard Care at KIR|Participants will receive the standard care provided at Kessler Institute for Rehabilitation.
15932155|NCT03402893|Drug|ONEXTON Topical Gel|Onexton gel applied once daily to face
15932156|NCT03402880|Biological|Pembrolizumab|Given IV
15932157|NCT03402880|Drug|Epacadostat|Given PO
15932158|NCT03402880|Other|Laboratory Biomarker Analysis|Correlative studies
15932159|NCT03402867|Procedure|Deep dry needling|Insertion of a filiform needle in the active trigger point of musculoskeletal muscle
15932160|NCT03402854|Device|active transcranial direct current stimulation|Participants will receive 20 min of tDCS over the scalp during the first 20 min of bimanual training.
15932161|NCT03402854|Behavioral|bimanual training|Participants will engage in movements that use both hands, by playing with toys and games.
15932162|NCT03402841|Drug|Olaparib|300 mg twice daily - oral
15932163|NCT03402828|Drug|Any topical drug treatment|Any treatment strategy used to prevent relapse of psoriasis symptoms
15932164|NCT03402815|Drug|Maraviroc 300 mg|Patients were randomly allocated with an AB/BA cross over design to either maraviroc 300 mg/day to current ART for 24 weeks (A) or no additional treatment (B). At the end of the first 24-week period patients were switched to the alternative arm.
15932165|NCT03402802|Drug|monitoring of adherence with medication|persons taking routine postoperative eye drops will have their frequency of drop taking monitored
15932166|NCT03402789|Drug|Docosahexaenoic Acid|Docosahexaenoic acid 1,200mg daily plus 2 hours of eye patching daily
15932167|NCT03402789|Drug|Placebo Oral Tablet|Placebo tablet daily plus 2 hours of eye patching daily
15932168|NCT03402776|Drug|4th dose of hexavalent vaccine 1 month after the 3rd dose|4th dose of hexavalent vaccine 1 month after the 3rd dose
15932169|NCT03402763|Behavioral|Educational Video|The intervention is an educational video presented to patients in the ED with the intent to promote ACP among older adults.
15932170|NCT03402763|Behavioral|Primary Care Provider Email|For intervention patients, an email will be sent to primary care providers explaining that the patient has seen a video about advance care planning, providing a synopsis of the video, and giving instructions about how to document end-of-life care preferences in the electronic health record.
15932171|NCT03402750|Behavioral|Meds to Beds|Medications will be delivered to patient bedside before discharge
15932172|NCT03402750|Behavioral|Electronic Prescription|Patient or surrogate can pick up medication from pharmacy
15932173|NCT03402737|Radiation|Stereotactic body radiotherapy|"The range of dose-painting will be escalated in following levels:
~2x 6-8Gy (day 1-4)
~3x 6-8Gy (day 1-4-7)
~3x 6-10Gy (day 1-4-7)
~3x 6-12Gy (day 1-4-7)
~Patients will take cyclophosphamide orally 50 mg tablets, 1 tablet a day from the first day of irradiation for 8 consecutive weeks.
~Nivolumab will be considered as standard therapy in patients with cisplatin refractory locoregional disease recurrence. Nivolumab will be administered as per current standard of care. In case patients that are treated with nivolumab will be included in the trial, they will not be treated with cyclophosphamide."
15932174|NCT03402724|Other|echographic|Patients are called for an echographic evaluation in the implanting center in case of the usual care
15932175|NCT03402698|Dietary Supplement|cholecalciferol|supplementation at a dose 1000 IU/d
15932176|NCT03402685|Device|ClearSight|Patients in the intervention group receive management of volume and vasopressor settings according to the non-invasive ClearSight system.
15932177|NCT03402672|Other|self-administered, e-health application|"AWAITS is a self-administered, e-health application and includes short videos in which patients who are successfully engaged in MAT discuss what they wish they had known about MAT when they were actively using. The intervention is designed to maximize scalability - the administration would entail handing an electronic device (e.g., tablet, laptop, etc.) to an individual who would then self-administer the intervention."
15932180|NCT03402646|Behavioral|Reminder module (SMS and Phone call)|Same as described under arm/group descriptions
15932181|NCT03402646|Behavioral|Photovoice|Same as described under arm/group descriptions
15932182|NCT03402633|Other|Examination of leukotrichia in vitiligo patients|Examination of leukotrichia will be enhanced by wood's light and dermoscopy for better enhancing of the lesions and good magnification
15932183|NCT03402620|Drug|Gonadotropins|Human menopausal gonadotropin 75 IU ampoules start at cycle day 2
15932184|NCT03402607|Procedure|Percutaneous Local Abalation|Microwave Ablation (MWA) is a form of percutaneous localized ablation using thermal ablation techniques to treat cancer via direct coagulative necrosis. Microwaves can generate high temperatures in a short period of time; MWA has the potential to improve treatment efficacy over radiofrequency ablation as it can be used to treat larger lesions and has less susceptibility to heat-sink due to vessel proximity. MWA uses electromagnetic waves (300 MHz to 300 GHz) to produce oscillation of polar molecules within tissue; this generates tissue necrosis through frictional heating. For HCC, one or more microwave antennae are inserted into the liver, usually under the guidance of ultrasonography or computed tomography (CT). Frequency and length of treatment is determined on a case by case basis depending on tumor size and proximity to vessels or other organs at risk.
15932185|NCT03402607|Radiation|Hypofractionated Image Guided Radiation Therapy|HIGRT represents the only non-invasive curative modality in the management of HCC. HCC patients typically have a host of other medical comorbidities complicated by underlying liver dysfunction that makes the implementation of liver-directed therapy challenging. Presently HIGRT is typically offered only after alternative surgical (transplantation/hepatectomy) and non-operative approaches (PLA/embolization) have been exhausted.
15932186|NCT03402594|Device|High flow oxygen|Heated humidified high flow oxygen cannula (Optiflow; temperature of 34°C and fractional inspired oxygen of 0.24) with a flow rate of 20 liter/minute
15932187|NCT03402594|Device|Low flow oxygen|Oxygen cannula with a flow rate of 2 liter/minute
15932188|NCT03402581|Device|c-mac laryngoscope|type of laryngoscopes
15932189|NCT03402555|Other|Stool pattern|Collection of stool images
15932190|NCT03402542|Procedure|Cholecystectomy|Cholecystectomy
15932191|NCT03402529|Diagnostic Test|Contrast Enhanced Spectral Mammography|Pilot study
15932192|NCT03402516|Device|18.5 resector|hysteroscopic myomectomy with a 18.5 Fr resector after cervical dilatation until Hegar bougie number 7
15932193|NCT03402516|Device|26Fr resector|hysteroscopic myomectomy with a 26Fr resector after cervical dilatation until Hegar bougie number 10
15932194|NCT03402503|Drug|Montelukast buccal film|Film with active investigational product (montelukast) inserted and applied on inner cheek
15932195|NCT03402503|Other|Placebo buccal film|Film with placebo (no active drug) inserted and applied on inner cheek
15932196|NCT03402490|Behavioral|Motivational interviewing|
15932197|NCT03402464|Drug|Icotinib combined dihydroaremisinin|Icotinib should be taken by the patients continuously until disease progressed or intolerable toxicity. On day 1-3, oral dihydroaremisinin was given at 20mg per day, the dose of dihydroaremisinin is increased to 40mg daily on day 4 to 6, and 80mg twice daily until disease progressed or intolerable toxicity.
15932198|NCT03402438|Drug|Fulacimstat (BAY1142524)|single oral dose of 25 mg immediate-release tablet BAY1142524
15932199|NCT03402425|Diagnostic Test|18F-FET PET|Patient are investigated with an 18F-FET PET
15932200|NCT03402412|Other|narrow-band UVB|Standard established treatment for atopic dermatitis with narrow-band UVB will be used in this study but initially only on a small amount of skin to assess what changes takes place in the skin.
15932201|NCT03402399|Other|Molecular analysis|Blood test
15932202|NCT03402386|Drug|MT-6548|Oral tablet
15932203|NCT03402373|Dietary Supplement|Lycoderm|soft gel contains nutritional supplement
15932204|NCT03402373|Dietary Supplement|Placebo|soft gel without active ingredients
15932205|NCT03402360|Other|Virtual Reality rehabilitation group|"Three hours rehabilitation sessions every day that will consist in two hours of physiotherapy and one hour of neurocognitive rehabilitation, for 15 consecutive working days (3 weeks).
~1 hour: conventional physiotherapy
~1 hour: virtual reality upper extremity motor rehabilitation
~1 hour: virtual reality neurocognitive training"
15932206|NCT03402360|Other|Control group rehabilitation|"Three hours rehabilitation sessions every day that will consist in two hours of physiotherapy and one hour of neurocognitive rehabilitation, for 15 consecutive working days (3 weeks).
~1 hour: conventional physiotherapy
~1 hour: upper extremity motor rehabilitation
~1 hour: neurocognitive training"
15932207|NCT03402347|Radiation|Non-ionising radiation|Laser regimes will be applied to ex vivo skin samples.
15932208|NCT03402334|Behavioral|Patient counseling for HCV associated CVD risk factors|Patients will be counseled for cardiovascular disease risk factors associated with Hepatitis C infection. Such risk factors include atherosclerosis, heart attack, and stroke. Cardiovascular risk factors can be managed through connection with primary care and reduced through curative HCV treatment.
15932209|NCT03402321|Drug|Gelatin Sponge Sheet|sheets act as a mechanical barrier used to protect the denuded area of the palatal donor site
15932210|NCT03402321|Drug|Alvogyl|paste form with analgesic action to protect the palatal donor site and help to relief pain
15932211|NCT03402308|Dietary Supplement|Schisandra chinensis extract|Schisandra chinensis extract 1,000 mg/day for 12 weeks
15932212|NCT03402308|Dietary Supplement|Placebo|Starch placebo 1,000 mg/day for 12 weeks
15932213|NCT03402295|Drug|Bortezomib, cyclophosphamide, thalidomide, dexamethasone|Comparison between two triple combination chemotherapy that include in different new drugs (bortezomibe e talidomida)
15932217|NCT03402256|Behavioral|Text Message|In addition to the SC interventions, participants in the Text Message condition received text messages. Participants received 3 text messages per day for the first four weeks of the study and 3 messages per week for the last four weeks. Participants will receive messages targeting known predictors of alcohol abstinence and relapse, including (1) craving, (2) identification of high-risk situations, (3) identification of triggers, (4) stress level, (5) coping skills, and (5) quality of life. The text messages will include motivational messages and behavior-change techniques (e.g. coping with cravings and urges to drink, trigger identification, high-risk situation identification). Messages will encourage participants to continue with sobriety and focus on the success they have achieved so far.
15932218|NCT03402243|Other|Menthol ban on cigarettes|Participants will have menthol and tobacco flavored e-cigarettes available but only non-menthol cigarettes
15932219|NCT03402243|Other|Menthol ban on cigarettes and e-cigarettes|Participants will have neither menthol flavored cigarettes or e-cigarettes available
15932220|NCT03402243|Other|No menthol ban|Participant will have menthol and tobacco flavored cigarettes and e-cigarettes available
15932221|NCT03402230|Drug|Broccoli Sprout/Broccoli Seed Extract Supplement|Given PO
15932222|NCT03402230|Other|Laboratory Biomarker Analysis|Correlative studies
15932223|NCT03402230|Other|Questionnaire Administration|Ancillary studies
15932224|NCT03402217|Behavioral|Patient Centered Postpartum Contraception App|This is a theory-based smart phone-based application designed to provide immediate postpartum contraception information to young women aged 15-25.
15932225|NCT03402204|Drug|Simvastatin 10 mg|"Simvastatin is a cholesterol-lowering medication that blocks the production of cholesterol (a type of fat) in the body.
~Simvastatin reduces low-density lipoprotein (LDL) cholesterol and total cholesterol in the blood. Lowering your cholesterol can help prevent heart disease and hardening of the arteries, conditions that can lead to heart attack, stroke, and vascular disease."
15932226|NCT03402204|Drug|Simvastatin 40 mg|"Simvastatin is a cholesterol-lowering medication that blocks the production of cholesterol (a type of fat) in the body.
~Simvastatin reduces low-density lipoprotein (LDL) cholesterol and total cholesterol in the blood. Lowering your cholesterol can help prevent heart disease and hardening of the arteries, conditions that can lead to heart attack, stroke, and vascular disease."
15932227|NCT03402191|Drug|L-arginine|l-arginine for thalassemia with pulmonary hypertension
15932228|NCT03402191|Drug|Sildenafil|Sildenafil for thalassemia with pulmonary hypertension
15932229|NCT03402178|Drug|E2082|Solution (0.2 mg) or tablet (0.5 mg and 5 mg).
15932230|NCT03402178|Drug|Placebo|Solution (0.2 mg) or tablet (0.5 mg and 5 mg) matched to E2082.
15932231|NCT03402165|Drug|Sofosbuvir and Ledipasvir or sofosbuvir and daklatasuvir|Response to DAAD's and developing HCC
15932232|NCT03402152|Drug|NRX-101|NRX-101, a fixed dose combination of D-cycloserine+lurasidone will be given twice a day by mouth
15932233|NCT03402152|Drug|Lurasidone HCl|Lurasidone HCl will be given twice a day by mouth
15932234|NCT03402152|Drug|Placebo|Placebo oral capsule
15932235|NCT03402126|Other|TPD RAMWare|TPD RAMWare injected into enrolled subject's device.
15932460|NCT03400423|Drug|Caffeine|Oral administration of 1.2mg/kg of powdered caffeine with water.
15932236|NCT03402113|Drug|Dexmedetomidine|consistent infusion at a loading dose of 0.15ug/kg/h, increased by 0.15ug/kg/h, with a maximum dose of 1.5ug/kg/h.
15932237|NCT03402113|Drug|Midazolam|consistent infusion at a loading dose of 1mg/h, increased by 1mg/h, with a maximum dose of 10mg/h.
15932238|NCT03402100|Drug|eye drops|children who received daily eye drops for myopia
15932239|NCT03402087|Drug|Methotrexate|Specified dose on specified days
15932240|NCT03402087|Drug|Leucovorin|Specified dose on specified days
15932241|NCT03402087|Drug|BMS-986165|Specified dose on specified days
15932242|NCT03402074|Behavioral|Group hypnosis|5 session of group hypnosis, each 90 minutes, to reduce subjective stress and increase relaxation. Additional auditapes of hypnosis sessions as hoemwork
15932243|NCT03402061|Dietary Supplement|nutrient enhanced recipes|normal ingredients will be substituted to promote nutrient density of products
15932244|NCT03402048|Drug|Carboplatin|
15932245|NCT03402048|Drug|Gemcitabine|
15932246|NCT03402048|Drug|Pemetrexed|
15932247|NCT03402048|Drug|Docetaxel|
15932248|NCT03402048|Drug|Vinorelbine|
15932249|NCT03402009|Behavioral|Apps|Apps and weblinks to coach self-guided meditation.
15932250|NCT03402009|Behavioral|EEG neurofeedback|Device provides feedback based on EEG readings.
15932251|NCT03401996|Device|1 mA tDCS over bilateral SMA|"A 1mA direct current will be delivered through two 5cm x 5cm saline-soaked surface sponge electrodes by a battery-driven, constant-current stimulator (Neuroconn DC stimulator). First, the SMA will be identified based on the guidelines of the international 10-20 electrode system. The tDCS will then be applied using the following procedure:
~The head of participants will be measured to find the 'vertex' (top) of the head. This point will be used as a landmark to locate the SMA. This region corresponds to the FCZ (e.g., Legon et al., 2013).
~The return electrode will be placed over the mastoids. Once the electrodes are in position, cathodal tDCS will be applied at 1mA for 15 minutes, 2 times a day with a resting period of 20 minutes in between treatment periods, for 5 consecutive days."
15932252|NCT03401983|Other|Pelvic Floor Muscle Training and Abdominal Training|Pelvic Floor Muscle Training + Abdominal Training program was used in the study. The follow-up measurements of the PFMT+AT group were obtained in the 0th, 4th, and 8th weeks.
15932253|NCT03401983|Other|Pelvic Floor Muscle Training|Pelvic Floor Muscle Training program was used in the study. The follow-up measurements of the PFMT group were obtained in the 0th, 4th, and 8th weeks.
15932254|NCT03401970|Behavioral|Acellular carbohydrate diet|Participants will be asked to consume 2,000 - 2,500 kcals, thereof 45 energy percent (E%) carbohydrate (up to 5 E% added sugar), 30 E% fat (10-12 E% saturated fatty acids and 7-10 E% polyunsaturated fatty acids) and 17 E% protein. They will use an original online/smartphone application that provides choices of meals/food combinations/recipes corresponding to their prescribed macronutrient profile and dietary pattern. Participants are asked to complete 3-day dietary records every 14 days throughout the study, and to report any deviations from the planned interventions.
15932255|NCT03401970|Behavioral|Cellular carbohydrate diet|Participants will be asked to consume 2,000 - 2,500 kcals, thereof 45 energy percent (E%) carbohydrate (up to 1 E% added sugar), 38 E% fat (10-12 E% saturated fatty acids and 7-10 E% polyunsaturated fatty acids) and 17 E% protein. They will use an original online/smartphone application that provides choices of meals/food combinations/recipes corresponding to their prescribed macronutrient profile and dietary pattern. Participants are asked to complete 3-day dietary records every 14 days throughout the study, and to report any deviations from the planned interventions.
15932256|NCT03401970|Behavioral|Low-carbohydrate high-fat diet|Participants will be asked to consume 2,000 - 2,500 kcals, thereof 10 energy percent (E%) carbohydrate (up to 1 E% added sugar), 73 E% fat (30 E% saturated fatty acids and 7-10 E% polyunsaturated fatty acids) and 17 E% protein. They will use an original online/smartphone application that provides choices of meals/food combinations/recipes corresponding to their prescribed macronutrient profile and dietary pattern. Participants are asked to complete 3-day dietary records every 14 days throughout the study, and to report any deviations from the planned interventions.
15932257|NCT03401957|Drug|Cetuximab|Cetuximab-based infusional 5-FU regimen as the 1st line treatment.
15932258|NCT03401957|Diagnostic Test|liquid biopsy|The blood samples taken from subjects will be evaluated for RAS genotype using MassARRAY technique.
15932259|NCT03401944|Drug|TPN|
15932260|NCT03401944|Other|Control|
15932261|NCT03401918|Diagnostic Test|Uterine ERA and microbiome testing|Uterine fluid and endometrial biopsy collection to test uterine endometrial receptivity array and microbiome.
15932262|NCT03401918|Drug|Oral antibiotics and vaginal probiotics|For subjects with abnormal microbiome results, oral antibiotics and vaginal probiotic treatment will be offered followed by a repeat uterine microbiome biopsy.
15932263|NCT03401905|Procedure|Low frequency|A dry needling on trapezius muscle is performed, until two local twitch responses are obtained. The needle is kept inside the trigger point, as it will be the negative electrode, and an adhesive electrode will be added as the positive one. After that, a low frequency TENS is applied, at 2 Hz frequency and 120 microseconds of pulse width.
15932264|NCT03401905|Procedure|High frequency|A dry needling on trapezius muscle is performed, until two local twitch responses are obtained. The needle is kept inside the trigger point, as it will be the negative electrode, and an adhesive electrode will be added as the positive one. After that, a high frequency TENS is applied, at 12o Hz frequency and 200 microseconds of pulse width.
15932265|NCT03401892|Device|Dynamic Vessel Analyzer (DVA)|Retinal vessel diameters and oxygen saturation will be measured with the DVA device.
15932266|NCT03401892|Device|Fourier Domain Doppler Optical Coherence Tomography (FDOCT)|Retinal blood flow will be assessed using FDOCT.
15932267|NCT03401892|Device|Optical coherence tomography (OCT)|Nerve fiber layer thickness and central retinal thickness will be measured using OCT.
15932268|NCT03401879|Device|Dynamic Vessel Analyzer (DVA)|Retinal vessel diameters and oxygen saturation will be measured with the DVA device.
15932269|NCT03401879|Device|Fourier Domain Doppler Optical Coherence Tomography (FDOCT)|Retinal blood flow will be assessed using FDOCT.
15932270|NCT03401879|Device|Optical coherence tomography (OCT)|Nerve fiber layer thickness and central retinal thickness will be measured using OCT.
15932271|NCT03401879|Device|Optical coherence tomography angiography (OCTA)|Retinal microvasculature will be assessed using OCTA.
15932799|NCT03398005|Drug|CaPre|4 x 1 g capsules administered orally once a day for 26 weeks
15932272|NCT03401866|Diagnostic Test|DSC-MRI|"The multiple dose protocol with sequential DSC-MRI scans enables comparison of BTIP compliant and double-dose injections schemes."
15932273|NCT03401853|Other|Laboratory Biomarker Analysis|Correlative studies
15932274|NCT03401853|Biological|Pembrolizumab|Given IV
15932275|NCT03401853|Biological|Rituximab|Given IV
15932276|NCT03401853|Biological|Obinutuzumab|Given IV
15932277|NCT03401840|Radiation|postoperative hypofractionated stereotactic radiotherapy|total dose of 36Gy in 6 fractions over 11-13 days
15932278|NCT03401827|Drug|Chemotherapy (Gemcitabine + nab-paclitaxel)|"Nanoparticle albumin-bound paclitaxel (125 mg/m2) miv over 30 min, Day 1,8,15
~Gemcitabine (1,000mg/m2) and N/S 150mL miv over 30 min, Day 1,8,15"
15932279|NCT03401814|Other|Magnetic Resonance Elastography|rapidly developing technology for quantitatively assessing the mechanical properties of tissue, using externally applied mechanical waves
15932280|NCT03401801|Procedure|Stellate ganglion block|Well trained pain physician performs all the ultrasound(US)-guided stellate ganglion block(SGB)s, who is not involved in evaluating study variables. Electrocardiography, noninvasive blood pressure, heart rate, and peripheral oxygen saturation were monitored for all patients before, while, and after conducting procedure. For US-guided SGB, patients are supine positioned, and skin preparation on injection site is done with chlorohexidine. Procedure is conducted under ultrasound guidance at C6 level. 4 ml, 6 ml, and 8 ml of 1% lidocaine is injected for the each group, respectively.
15932281|NCT03401788|Drug|Belzutifan|120 mg once daily (three 40 mg oral tablets once daily).
15932282|NCT03401775|Other|Cognitive rehabilitation program|Cognitive rehabilitation programs have been developed to improve the cognitive functions of the elderly or patients with cognitive impairments. The program includes sub-categories such as attention, working memory, memory and executive functions with various levels of difficulty.
15932283|NCT03401762|Behavioral|MCI|EMG-controlled game
15932284|NCT03401762|Behavioral|Sham MCI|Sham control game
15932285|NCT03401749|Drug|Chlorhexidine Gluconate 2% Wipe|Patients will be instructed to use CHG wipes after showering the night before surgery and again on the morning of surgery.
15932286|NCT03401749|Other|Theraworx Bath Wipes|Theraworx TM is a cosmetic product that is a non-rinse skin formulation that combines multiple ingredients, including Aloe Concentrate, Allantoin, Tego Betaine F 50, Tego Betaine L-7, Lauryl Glucoside, Abil 8852, Vitamin E, Natural Fragrances, Methyl paraben, Propyl paraben, EDTA, Antimicrobial Preservative, Colloidal Silver, and Beta Glucan, in preoperative disposable bath wipes. The main proposed antimicrobial mechanism of action involves the local reduction in skin pH to around 4.6.
15932287|NCT03401736|Device|Mechanical Ventilation|Whether midazolam and dexmedetomidine have an effect on the diversity of intestinal microbiota or not is still unknown，especially the patient who requires the mechanical ventilation.
15932288|NCT03401736|Drug|Midazolam|The impact of Midazolam on the diversity of intestinal microbiota.
15932289|NCT03401736|Drug|Dexmedetomidine|The impact of dexmedetomidine on the diversity of intestinal microbiota.
15932290|NCT03401723|Other|3D-Colonoscopy Progression Score|3D-Colonoscopy Progression Score is a computerized analysis of the movement of the colonoscope based on data from coils within the colonoscope.
15932291|NCT03401723|Other|Endoscopy Training System|"The Endoscopy Training System is based on the Colonoscopy Training Model platform and includes four different performance metrics and a scoring system.
~Scope Manipulation - The use of torque and tip deflection to move a shape in the colon
~Tool Targeting - 10 targets located around the colon must be found. With a biopsy forceps, each target has to been touched.
~Loop Management - The management of a standard alfa-loop.
~Mucosal Inspection - Randomly placed polyps inside the rubber colon have to be found during withdrawal."
15932292|NCT03401723|Other|3D-Colonoscopy Retraction Score|3D-Colonoscopy Retraction Score is a computerized analysis of the movement of the colonoscope based on data from coils within the colonoscope.
15932293|NCT03401710|Drug|Erythropoietin|Erythropoietin 4000 UI will be administered every other day subcutaneously
15932294|NCT03401684|Behavioral|Resilient Minds|The program is designed: 1) to decrease the risk of developing a stress disorder or other mental illnesses due to workplace incidents and/or unhealthy stress; 2) to mitigate the negative impacts of mental illness and trauma through early recognition and early intervention; 3) to support the public while on the frontline; and 4) to improve the psychological health of fire staff while cultivating resilience and enhancing quality of life.
15932295|NCT03401671|Drug|Lanadelumab|SC injection of 300mg in 2mL (150 mg/mL) solution of lanadelumab will be administered as a single dose injection in the abdomen.
15932296|NCT03401658|Device|Sensor light detector|The intervention is based on a sensor technology that gathers data and transmit it to another location for processing. The monitoring utilises an LED light source, an integral detector set which has variance from device to device and chromatic based algorithms for extraction of information from the detectors. The integration of these components into a system provides robustness and stability for operation. The availability of smartphones which possess high quality cameras and constant internet connectivity provides an ideal platform for multimedia clinical data collection and real-time patient-provider communication.
15932297|NCT03401645|Other|Wrist Alarm|Wrist device with alarm timer
15932298|NCT03401645|Behavioral|Home-based Arm and Hand Exercise|Repeated visuomotor tasks, unilateral arm and hand movements, bilateral arm and hand movements
15932299|NCT03401632|Other|Enteral nutrition|Enteral nutrition support
15932300|NCT03401619|Combination Product|Exercise，Nutrition，Bisphosphonates，Statins，Calcitonin,Vitamin D，et al.|The long-term effect of comprehensive treatment on health, especially for osteoporosis and neurodegenerative diseases, we hope to find association from epigenetics and provide clues for further exploration of its pathogenesis.
15932301|NCT03401606|Drug|remifentanil|remifentanil, 0.25 ng/mL, given intravenous, infusion, until surgery finished
15932302|NCT03401606|Drug|Dexmedetomidine|dexmedetomidine, 0.125 mcg/kg/hour, given intravenous, infusion, until surgery finished
15932338|NCT03401359|Genetic|tissue biopsy, blood sample|At baseline, 100 tumor/blood samples will be banked. Only ~60 will be profiled if the paired samples are acquired post-progression or on-treatment. On-treatment blood samples will be serially collected and banked from all consenting patients.
15932339|NCT03401346|Combination Product|INP104|Dihydroergotamine Mesylate (DHE) administered via I123 Precision Olfactory Delivery (POD) Device
15967364|NCT03132103|Dietary Supplement|Placebo Oral Vitamin D3|
15932303|NCT03401593|Drug|midazolam with fentanyl|Radio-frequency catheter ablation is performed in the post-absorptive state after sedation with midazolam and fentanyl. Multipolar catheters were positioned in the coronary sinus, His, and the right atrium. The three-dimensional LA geometry was reconstructed using a CARTO or NavX electroanatomical mapping system. Circumferential pulmonary vein isolation was performed in all patients using a irrigated-tip catheter. A circular mapping catheter was used to confirm the isolation of the pulmonary veins. Successful ablation was defined by the elimination of all the pulmonary vein potentials along the antrum or inside the veins. If the AF was not terminated after elimination of all the pulmonary vein potentials, linear ablation and complex fragmented atrial electrogram ablation were performed.
15932304|NCT03401580|Drug|Viena II 160/10|once daily
15932305|NCT03401580|Drug|Viena II 190/10|once daily
15932306|NCT03401580|Drug|Viena II 160/12|once daily
15932307|NCT03401580|Drug|Viena II 190/12|once daily
15932308|NCT03401567|Other|Exercise group|Elbow bending exercises with blood flow restriction will be performed to the exercise group during 6 weeks for 3 times a week. The first set of exercises will be 30 repetitions then 3 sets of 15 repetitions. Totally 75 repetitions will be performed. 30 seconds rest interval between sets will be given.
15932309|NCT03401554|Procedure|titanium mesh|closing the lateral window for maxillary sinus floor elevation with titanium mesh
15932310|NCT03401554|Procedure|collagen membrane|closing the lateral window for maxillary sinus floor elevaion with collagen membrane
15932311|NCT03401541|Drug|Calcifediol|One capsule of 900 micrograms of 25(OH)D
15932312|NCT03401541|Drug|Calciferol|One capsule of 900 micrograms of Vitamin D
15932313|NCT03401528|Drug|AVB-S6-500|AVB-S6-500 is an investigational drug.
15932314|NCT03401528|Other|Placebo|Matching placebo
15932315|NCT03401515|Drug|Propranolol Hydrochloride 1 MG/ML|Propranolol 1 mg every 6 hrs in the first 24 hrs after isolated blunt traumatic brain injury
15932316|NCT03401515|Other|Normal saline|Normal Saline 1 ml every 6 hrs
15932317|NCT03401502|Drug|Ranolazine|Oral, b.i.d
15932318|NCT03401502|Drug|Placebos|Oral, b.i.d
15932319|NCT03401489|Device|PACESETTER|Patients will be given a Viaca electronic pill tray & blue-toothed UA-767 Plus BT BP device and the PACESETTER app installed on their smart phone for automatic relay of BP data. The Vaica tray emits a blinking light for 30 minutes when it is time to take the meds. If the compartment is not opened and emptied, an intermittent chime ensues for 30 minutes. If the compartment is not opened and emptied, the subject /caregiver receives an automated SMS. PACESETTERs will be given a questionnaire. Responses will be used to generate personalized motivational & reinforcement messages guided by self-determination theory constructs of competence & autonomous regulation. In addition to personalized messages, PACESETTERs will receive text messages 2 times per week on HTN/stroke facts, importance of med adherence, and tips on expressing questions/concerns with a physician. We will calculate medication possession ratios, on all subjects' HTN medications at each evaluation.
15932320|NCT03401476|Drug|Morphine Sulfate|Morphine Sulfate Tablets
15932321|NCT03401463|Other|traning seminar|There will be provided 30 min training seminar on the function of endotracheal cuff and cuff pressure.
15932322|NCT03401450|Drug|ACB within true AC with bupivacaine 0.5% 20cc|The adductor canal block (ACB) is more commonly being used to provide post-operative analgesia since it provides a sensory block with minimal motor block.
15932323|NCT03401450|Drug|ACB proximal to true AC with bupivacaine 0.5% 20cc|Patients will receive ultra-sound guided single femoral triangle block injection with 20 mL of 0.5% bupivicaine
15932324|NCT03401437|Behavioral|SF-36|Evaluation of the quality of life with an auto-questionnaire validated, with 8 dimensions: physical activity ; limitations due to physical condition; physical pain; perceived health; vitality; life and relationship with others; limitations due to physical condition; psychic health as well as the assessment of perceived health compared to a year ago. Evaluation done pre-operatively, at M1 and M3
15932325|NCT03401437|Behavioral|HAD|Evaluation of anxiety and depression with a scale validated with 14 items assess between 0 and 3. Evaluation done pre-operatively and at M3.
15932326|NCT03401437|Other|ANSM|Additional information requested by the ANSM (french National Agency for Medicines and Health Products Safety) following a materiovigilance report. Evaluation done pre-operatively and at M3.
15932327|NCT03401424|Procedure|improved Warren-type style|Select 60 cases of biliary dilatation in patients undergoing laparoscopic cyst excision plus modified Warren cholangiobiliary reconstruction.
15932328|NCT03401424|Procedure|Roux-en-Y style|Select 60 cases of biliary dilatation in patients undergoing laparoscopic cyst excision Roux-en-Y cholangiobiliary reconstruction.
15932329|NCT03401411|Behavioral|Survey|Survey of 15 fictional patient case scenarios to be assessed by participant using the standard prioritization or modified SCCMP to prioritize each patient scenario into one of a 5-point likert-scale categories for ICU admission. SCCMP scale categorized as 1-Critically ill to 4-Less likely to require ICU.
15932330|NCT03401411|Behavioral|Algorithm-based Triage Tool|Newly designed flowchart-based triage guide to prioritize each patient case scenario into one of the 5-point likert-scale categories, used in conjunction with SCCMP for ICU admission.
15932331|NCT03401398|Drug|Hydrocortisone, sodium succinate|Patients randomized to the hydrocortisone treatment arm will receive an initial bolus of 2 mg/kg IV hydrocortisone, followed by 1 mg/kg (maximum 50 mg) of hydrocortisone dosed every six hours for a maximum of seven days or until all vasoactive infusions have been discontinued for at least 12 hours, whichever comes first. When the hydrocortisone course is completed, the medication will be discontinued.
15932332|NCT03401398|Drug|Normal saline|Patients randomized to the placebo treatment arm will receive an equivalent volume of normal saline, with the identical dosing schedule to the intervention (hydrocortisone) arm.
15932333|NCT03401385|Drug|DS-1062a|A total anti-TROP2 antibody and MAAA-1181a
15932334|NCT03401372|Drug|Doxycycline|Oral doxycycline 100mg twice daily
15932335|NCT03401372|Drug|Bortezomib|1.3mg/m2 of bortezomib on days 1, 8, 15 and 22 of a 35-day cycle
15932336|NCT03401372|Drug|Cyclophosphamide|300mg/m2 cyclophosphamide on days 1, 8, 15 and 22 of a 35-day cycle
15932337|NCT03401372|Drug|Dexamethasone|40mg of dexamethasone on days 1, 8, 15 and 22 of a 35-day cycle
15932340|NCT03401346|Drug|Dihydroergotamine Mesylate (DHE)|Dihydroergotamine Mesylate (DHE) injection (intravenous)
15932800|NCT03398005|Drug|Placebo|4 x 1 g capsules administered orally once a day for 26 weeks
15932341|NCT03401346|Combination Product|Migranal Nasal Spray|Dihydroergotamine Mesylate (DHE) delivered via Migranal Nasal Spray pump
15932342|NCT03401333|Behavioral|Text Messaging and Brief Negotiation Interview|An in-person brief motivational intervention coupled with 4 weeks of motivational text messages
15932343|NCT03401320|Drug|Letrozole ISM|2.5 mg Femara + single IM injection of 50-400 mg Letrozole ISM
15932344|NCT03401294|Drug|FOLFOXIRI and Bevacizumab|Every 2 week for a total of 12 cycles
15932345|NCT03401281|Other|Coconut oil|50g extra virgin coconut oil daily for four weeks
15932346|NCT03401281|Other|Butter|50g butter daily for four weeks
15932347|NCT03401281|Other|Olive oil|50g extra virgin olive oil daily for four weeks
15932348|NCT03401268|Drug|subcutaneous immunoglobulin|24 patients demonstrating hypogammaglobulinemia post allogeneic HCT will be started on ScIG for a total of 6 months. Tolerability of the intervention will be assessed with qualitative questionnaires, as well as a financial analysis regarding the intervention.
15932349|NCT03401255|Other|Partosure test|To perform the analysis, a sample of cervicovaginal secretions is collected using a vaginal swab provided in the PAMG-1 Detection Test Kit.After removing the swab from its packaging, hold the swab in the middle of the stem and carefully insert the end of the swab into the vagina over a length of 5-7cm (using a speculum). Is not necessary for sampling), when the patient is lying down.Remove the swab from the vagina after 30 seconds. Once the swab has been removed, immediately place the end in the solvent vial provided for this purpose, then rinse the swab by repeating several rotations for 30 seconds. The strip is removed as soon as two bands are clearly visible in the test area, or after 5 minutes.Two bands in the test area indicate a positive result, while a line in the test area indicates a negative result. It is not recommended to read or interpret results beyond 10 minutes of immersion.
15932350|NCT03401229|Biological|Benralizumab 30 mg SC + Mometasone Furoate|"Benralizumab injection is 30mg/ml SC clear to opalescent, colourless to yellow solution in accessorized pre-filled syringe.
~Benralizumab 30 mg SC will be injected every 4 weeks for the first 3 doses - Weeks 0 , 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48. Total of 8 doses.
~Mometasone Furoate Nasal Spray (MFNS) - intranasal corticosteroid - 2 doses (1 dose = 50 micrograms/actuation) in each nostril twice daily. Total daily dose of 400mcg. MFNS will be used for a minimum of 4 weeks prior to randomization and will be continued throughout the study."
15932351|NCT03401229|Biological|Matching placebo SC + Mometasone Furoate|"Matching placebo injection is SC clear to opalescent, colourless to yellow solution in accessorized pre-filled syringe.
~Matching placebo SC will be injected every 4 weeks for the first 3 doses - Weeks 0 , 4 and 8 and every 8 weeks thereafter - Weeks 16, 24, 32, 40 and 48. Total of 8 doses.
~Mometasone Furoate Nasal Spray (MFNS) - intranasal corticosteroid - 2 doses (1 dose = 50 micrograms/actuation) in each nostril twice daily. Total daily dose of 400mcg. MFNS will be used for a minimum of 4 weeks prior to randomization and will be continued throughout the study."
15932352|NCT03401216|Device|SYNERGY 48 mm|Material: Platinum-Chromium alloy. Stent strut thickness: 0.0029-0.0032 inches. Polymer carrier composed of PLGA (poly(DL-lactide-co-glycolide)). Drug product: Everolimus, 1µg per 1 mm2. Stent diameters available: 2.25; 2.50; 2.75; 3.00; 3.50; 4.00 mm. Stent length: 48 mm. Nominal balloon pressure: 11 atm. (1117 kPa). Manufacturing company: Boston Scientific Corporation (USA)
15932353|NCT03401216|Procedure|PCI|Standard PCI procedure
15932354|NCT03401216|Procedure|3 month OCT follow-up|Optical coherence tomography imaging of target vessel within 3 month after PCI
15932355|NCT03401216|Procedure|6 month OCT follow-up|Optical coherence tomography imaging of target vessel within 5 month after PCI
15932356|NCT03401203|Procedure|Rotational atherectomy followed by balloon angioplasty|Percutaneous coronary intervention
15932357|NCT03401203|Procedure|Balloon angioplasty|Percutaneous coronary intervention
15932358|NCT03401190|Drug|CM4620 Injectable Emulsion (Low Dose)|CM4620-IE 1.0 mg/kg on Day 1 and then 1.4 mg/kg on Days 2-4, during the first phase of the study (Cohorts 1 and 2). All doses of CM4620-IE will be administered intravenously (IV) over 4 hours.
15932359|NCT03401190|Drug|CM4620 Injectable Emulsion (High Dose)|CM4620-IE 2.08 mg/kg on Days 1 and 2 and then 1.6 mg/kg on Days 3 and 4, during the second phase of the study (Cohorts 3 and 4). All doses of CM4620-IE will be administered intravenously (IV) over 4 hours.
15932360|NCT03401177|Drug|Naproxen 500 Mg|Naproxen is used as a tool to dampen the inflammation thought to be present in early phase Tendinopathy
15932361|NCT03401177|Drug|Placebo Oral Tablet|Placebo is used, to provide a control to the active group.
15932362|NCT03401177|Other|Heavy resistance training|Heavy slow resistance training - used in both groups subsequent to the initial week of NSAID or placebo treatment.
15932363|NCT03401138|Other|Preoperative Stroke Volume(SV)-guided fluid optimization|"Preoperative SV-guided hemodynamic optimization will be commenced with patients receiving 250ml fluid challenges over five minutes aiming to maximize SV. Maximal SV is defined as absence of a sustained rise in SV by at least 10% in response to a fluid challenge.
~PPI will be obtained from the Masimo Radical 7 (Masimo, Irvine, CA, USA) and NIRS from Invos 5100C (Medtronic, Minneapolis, MN, USA).
~BV measurements will use pulse dye densitometry (PDD) with Indocyanine Green (ICG). We will use the Dye Densitogram 3300 analyser Nihon Kohden (Tokyo, Japan) for registration of the spectrophotometrical absorption of ICG and calculation of BV."
15932364|NCT03401125|Other|Medical file data collection|The information described in the 'outcome measures' section will be collected from the medical files of the patients.
15932365|NCT03401112|Drug|IMR-687|Oral administration of once daily IMR-687
15932366|NCT03401099|Procedure|Radiofrequency ablation of CTI|Delivery of radiofrequency energy to the cavotricuspid isthmus (region of right atrial tissue between the tricuspid annulus and the inferior vena cava) until bidirectional block is achieved
15932367|NCT03401099|Procedure|Cryoballoon PVI|Cryoballoon application to the pulmonary veins aiming for Pulmonary Vein Isolation
15932368|NCT03401086|Other|Kinesio Taping|Kinesio Taping
15932369|NCT03401073|Drug|Intravenous immunoglobulin|Gamunex-C [immune globulin injection (human) 10% caprylate/chromatography purified] is a sterile solution of human immune globulin protein.
15932370|NCT03401073|Drug|0.9% Sodium Chloride|Sodium Chloride (also known as saline) is a solution of sodium chloride, or salt, and sterile water.
15932371|NCT03401060|Drug|Denosumab|Each subcutaneous injection will occur every 6 months during 3 years for a total of 7 injections
15932372|NCT03401060|Drug|Placebo|Each subcutaneous injection will occur every 6 months during 3 years for a total of 7 injections
15932373|NCT03401047|Drug|Estradiol|Subjects will receive graded doses of transdermal estradiol patches for up to 7 days. Blood estradiol tests will be performed daily, and the number of estradiol patches used will be adjusted to maintain serum estradiol levels of 250-400 pg/ml. Estradiol is a natural hormone.
15932374|NCT03401021|Other|Questionnaires set|Participants will be asked to respond to the demographic information sheet, Smoking characteristics sheet, the Fagerstrom Test of Nicotine Dependence, the Transtheoretical Model (TTM) variables, Smoking Self-efficacy Questionnaire (SEQ-12), Family Adaptation, Partnership, Growth, Affection, and Resolve (Family APGAR), and a smoking hazard questionnaire.
15932375|NCT03401008|Other|Oral manifestations|To do the most accurate clinical and radiological state of oral manifestations in the series of prevalent acromegaly patients followed in the endocrinology service of the CHU of Clermont-Ferrand.
15932376|NCT03400995|Drug|AK0529|A solution containing 300 mg radiolabelled AK0529.
15932377|NCT03400982|Diagnostic Test|Bone densitometry measurement|Bone densitometry and measurement of body composition
15932378|NCT03400969|Device|Glycerol 17%|Glycerol will be applied, using gauze on a lockable tweezer, at the end of the oral care procedure performed by a dentist.
15932379|NCT03400969|Device|Aequasyal (OGT)|Aequasyl (OGT) will be sprayed on the mucosa, at the end of the oral care procedure, preformed by a dentist.
15932380|NCT03400969|Device|Salient (new product)|Salient (new Product) will be applied/given on a spoon, at the end of the oral care procedure, preformed by a dentist.
15932381|NCT03400956|Drug|Vilaprisan (BAY1002670)|Orally, coated tablet 2 mg, once daily
15932382|NCT03400956|Drug|Placebo|Orally, coated tablet, once daily
15932385|NCT03400930|Other|Severe Acute Malnutrition|
15932386|NCT03400917|Biological|AV-GBM-1|Investigational treatment with AV-GBM-1
15932387|NCT03400904|Other|Patients with brain injury and mechanical ventilation exposed to extubation/tracheostomy|Extubation and/or tracheostomy if applicable
15932388|NCT03400891|Behavioral|Program based on the theory of planned behaviour|14 sessions of one hour to work TPB constructs: attitude, subjective norms, perceived behavioural control and intention.
15932389|NCT03400878|Biological|BCG-Japan|One dose of 0.05 ml BCG-Japan vaccine applied to the left deltoid region.
15932390|NCT03400878|Biological|BCG-Russia|One dose of 0.05 ml BCG-Russia vaccine applied to the left deltoid region.
15932391|NCT03400865|Drug|HCQ/CQ and CAB combined treatment|Subjects are treated with hydroxychloroquine sulfate tablets 5mg/kg Bid and cabergoline tablets 2mg/week for 3 months.After therapy of 3 months the medication will be stopped if does not reduce prl level more than 20% or failure to decrease prolactinoma size.
15932392|NCT03400852|Drug|MNK-1411|MNK-1411 (1 mg/mL suspension) for subcutaneous injection
15932393|NCT03400852|Other|Placebo|Placebo suspension for subcutaneous injection
15932394|NCT03400839|Diagnostic Test|Daily physical activity levels|Objectively measured physical activity using activity monitors.
15932395|NCT03400839|Diagnostic Test|6-minute walk test|Assessment of functional exercise capacity.
15932396|NCT03400839|Diagnostic Test|Cardiopulmonary exercise testing|Assessment of maximal exercise capacity.
15932397|NCT03400839|Diagnostic Test|Muscle Function|Assessment of muscle force, muscle endurance and muscle fatigability
15932398|NCT03400839|Diagnostic Test|Lung Function|Assessment of whole-body plethysmography and spirometry.
15932399|NCT03400839|Diagnostic Test|Body composition|Assessment of bioelectrical impedance.
15932400|NCT03400839|Diagnostic Test|HRQoL - SGRQ-I|"Assessment of Health-related quality of life by the Saint-George Respiratory questionnaire (SGRQ-I)"
15932401|NCT03400839|Diagnostic Test|Symptoms - UCSD/SOBQ|"Assessment of symptoms by the UCSD Short of breath questionnaire"
15932402|NCT03400839|Diagnostic Test|HRQoL - SF36|"Assessment of Health-related quality of life by the SF-36 questionnaire"
15932403|NCT03400839|Diagnostic Test|Anxiety and depression|"Assessment of anxiety and depression by the Hospital Anxiety And Depression (HADS) Scale"
15932404|NCT03400839|Diagnostic Test|Symptoms - mMRC|"Assessment of symptoms by the modified Medical Research Council (mMRC) scale"
15932405|NCT03400839|Diagnostic Test|Sleep quality|"Assessment of sleep by the Pitsburg Sleep Quality Index (PSQI)"
15932406|NCT03400839|Diagnostic Test|Sleepiness|"Assessment of sleepiness by the Epworth Sleepiness Scale"
15932407|NCT03400839|Diagnostic Test|Inflammatory markers and oxidative stress|"blood assessment of inflammatory markers: IL-2, IL-10, IL-6, IL-4 e IL-17A, TNF, Interferon-γ, CK and CRP.
~Blood assessment of oxidative stress: TRAP, SH, SOD, CAT, PON 1, Gpx, MDA, NOx, FOX and AOPP."
15932408|NCT03400839|Diagnostic Test|Functional performance tests|Timed-up-and-go at usual pace (TUGu) and at a fast pace (TUGf), four-metre gait speed test (4MGS), sit-to-stand test using three protocols: 30 seconds (30sec-STS), one minute (1min-STS) and five-repetition (5rep-STS) and Short Physical Performance Balance (SPPB).
15932409|NCT03400826|Drug|Simvastatin 40mg|The Treatment Group subjects will orally intake encapsulated Simvastatin 40 mg tablets daily for the 12 weeks duration with water in the evening.
15932410|NCT03400826|Drug|Placebo 40 mg|The Placebo group will orally intake encapsulated Starch 1500, 40 mg Placebo for 12 weeks duration with water in the evening.
15932411|NCT03400813|Behavioral|R-TEP EMDR|Recent Traumatic Episode Protocol Eye-Movement Desensitization and Reprocessing is a early and short adaption protocol of EMDR developed by Shapiro E. EMDR is a psychotherapeutic approach that can rapidly process disturbing experiences adaptively together with the aid of eye movements or other forms of bi-lateral stimulation.
15932412|NCT03400800|Drug|Inclisiran Sodium|Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
15932413|NCT03400800|Drug|Placebo|Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).
15932414|NCT03400787|Device|Latera Implant|Treatment with implant
15932415|NCT03400787|Device|Sham Procedure|Sham procedure where the Latera delivery device is inserted but no implant delivered.
15932416|NCT03400774|Other|Stair-climbing|Short bouts of moderate intensity stair-climbing
15932417|NCT03400748|Device|RF Ablation|The intervention consists of a bronchoscopic approach to ablate lung tumors with radio-frequency energy.
15932458|NCT03400449|Other|Conversational counseling|Conversational counseling
15932418|NCT03400735|Combination Product|Cefdinir/clavulanic acide 300/125 mg film-coated tablets|Cefdinir is already an approved drug. In this study, developed cefdinir/clavulanic acide combination will be compared against to cefdinir alone.
15932419|NCT03400735|Drug|Cefdinir 300Mg Capsule|Cefdinir is used as comparator
15932420|NCT03400722|Drug|Pergoveris|Two controlled ovarian stimulation within the same menstrual cycle. It will be followed by ovarian puncture, fertilisation of oocyte by IVI or ICSI, blastocyst vitrification. If there are 3-5 blastocysts, the embryo accumulation process will be completed and the unfrozen embryos transferred.
15932421|NCT03400722|Drug|Clomiphene|Two controlled ovarian stimulation within the same menstrual cycle. It will be followed by ovarian puncture, fertilisation of oocyte by IVI or ICSI, blastocyst vitrification. If there are 3-5 blastocysts, the embryo accumulation process will be completed and the unfrozen embryos transferred.
15932422|NCT03400709|Drug|N Acetylcysteine|Oral administration of drug, before, during and after Chemoradiotherapy including Cisplatin.
15932423|NCT03400709|Drug|Placebo Oral Tablet|Placebo treatment
15932424|NCT03400696|Behavioral|Lower carbohydrate diet|Focused on limiting dietary carbohydrates, eating healthy fat and protein sources, and engaging in physical activity
15932425|NCT03400696|Behavioral|Higher fiber diet|Focused on increasing dietary fiber, lowering fat intake from animal sources, and engaging in physical activity
15932426|NCT03400696|Behavioral|Physical activity focused|Focused on aerobic and resistance exercise, while following dietary guidelines <https://www.choosemyplate.gov>
15932427|NCT03400683|Drug|Misoprostol|200 microgram misoprostol in sublingual every four hours for a maximum of five doses
15932428|NCT03400683|Drug|Letrozole|15mg( letrozole 2.5mg) on three successive day
15932429|NCT03400683|Procedure|Foley's catheter|transcervical 16F Foley's catheter with 30 ml balloon capacity inserted under aseptic conditions
15932430|NCT03400670|Device|ventilator NCPAP|infants will be randomized into two different NCPAP groups
15932431|NCT03400657|Procedure|Multi-disciplinary Treatment|due to suggestion of Multi-disciplinary Treatment ,the patients would be suggested to chemotherapy or surgery.
15932432|NCT03400644|Device|Cervical collar|Cervical neck collar which is routinely made for post-laminoplasty patients
15932433|NCT03400631|Drug|Dextrose 0|Dextrose injection at time 0
15932434|NCT03400631|Drug|Aspiration 0|Aspiration only at time 0
15932435|NCT03400631|Drug|Dextrose 1|Dextrose injection at week 1
15932436|NCT03400631|Drug|Aspiration 1|Aspiration only at week 1
15932437|NCT03400618|Other|Moderate carbohydrate diet|30 E % carbohydrates included in the diet
15932438|NCT03400618|Other|Higher carbohydrate diet|50 E % carbohydrates included in the diet
15932439|NCT03400605|Other|Infant feeding questionnaire|Prospective infant feeding questionnaire administered over the telephone or in-person at 2 weeks and at 2, 4 and 6 months postpartum
15932440|NCT03400592|Drug|Irinotecan|180 mg/m2 IV once every 2 weeks until radiographically documented tumour progression, unacceptable toxicity, or withdrawal of consent by the patient
15932441|NCT03400592|Drug|nimotuzumab|400mg IV once weekly until radiographically documented tumour progression, unacceptable toxicity, or withdrawal of consent by the patient
15932442|NCT03400579|Device|autoRIC® device|The autoRIC® automatically delivers four RIC cycles of five minutes of pressure at 200 mm Hg followed by five minutes of no pressure for a total 40-min treatment period
15932443|NCT03400566|Behavioral|Narrative|Children will be read a story book featuring vegetables for a minimum of 7 times (including twice during the familiarization phase).
15932444|NCT03400566|Behavioral|Experiential|Children will receive hands on experience with the vegetable. They will get to listen, see, feel, touch and smell the actual vegetable during the two familiarization phases.
15932445|NCT03400553|Diagnostic Test|Blood analysis|The blood of the patients will be analyzed for troponin T measured with 3 different devices: 1) a point-of-care (POC) test performed in the ambulance or MUG, a handheld cobas h232 POC system® (Roche Diagnostics, Switzerland), 2) a POC test at the emergency room, a table top AQT90 FLEX® (Radiometer, The Netherlands) and 3) a central laboratory test performed on cobas® 8000 (Roche Diagnostics, Switzerland).
15932446|NCT03400540|Diagnostic Test|verbal instruction|Verbal instruction for pelvic floor contraction will be given to participants. Ultrasound examination will be conducted to asses urinary bladder displacement being a marker for pelvic floor muscle function.
15932447|NCT03400527|Other|Exercise|Participants will pedal on a stationary bicycle up to 25 minutes 2-3 times a week for 4 weeks at a self directed pace and intensity
15932448|NCT03400501|Drug|Insulin Degludec|Single daily dose of insulin degludec based on their fasting blood glucose levels and current long acting insulin dose
15932449|NCT03400501|Drug|Insulin Glargine|Single daily dose of insulin glargine based on their fasting blood glucose levels and current long acting insulin dose
15932450|NCT03400488|Drug|AZD5718 oral suspension|In all cohorts, randomized subjects will receive orally AZD5718 oral suspension SAD (60 mg) on Day 1 and MAD (180 mg, 360 mg and 600 mg) from Days 3 to 10. On Day 2, no dose will be given. In total each subject will receive 9 doses of AZD5718.
15932451|NCT03400488|Other|Placebo matching AZD5817 oral suspension|In all cohorts, randomized subjects will receive orally placebo matching AZD5718 oral suspension on Day 1 and from Days 3 to 10. On Day 2, no dose will be given.
15932452|NCT03400475|Drug|Simvastatin|One topical application in peri-implant gingival crevice
15932453|NCT03400475|Other|Placebo|One topical application in peri-implant gingival crevice
15932454|NCT03400462|Drug|NSAID|Nimesulide has anti-inflammatory and analgesic properties. Like other NSAIDs it inhibits the action of COX . If prostaglandins can not be further synthesized, so there is no factor able to excite local nociceptors. According to t must be taken regularly for a minimum 2 weeks to achieve appropriate blood concentration.
15932455|NCT03400462|Device|oral appliance|The stabilization appliance used in this study was a removable device for maxillary arch, made of hard acrylic. Appliance was fitted over occlusal and incisal surfaces of the teeth and precisely contacted with the teeth of opposing arch. It provided canine disocclusion of the posterior teeth during eccentric movements.
15932456|NCT03400462|Other|dry needling|Equipment: acupuncture needle 0,6*13 e.g. Dragon Medical Device, Visits schedule:( 1st visit - Day 1st , 2nd visit- 7 days after the 1st, 3rd visit- 7 days after the 2nd)
15932457|NCT03400449|Other|Video counseling|Video counseling
15932461|NCT03400423|Behavioral|Moderate Intensity Exercise|Moderate intensity exercise conducted on a treadmill. Moderate intensity exercise defined as (220-age)*0.6.
15932462|NCT03400410|Behavioral|Education Arm|The educational video will be an overview with brief pros and cons of all types of available hormonal contraception. There will be emphasis on the importance of condom use as part of dual method protection.
15932463|NCT03400397|Other|Cool Kids programme|A manualised cognitive behavioural treatment programme that consists of 10 session within 12-16 weeks each lasting 2 hours.
15932464|NCT03400384|Other|Direct-to-consumer educational brochure|The intervention arm will be mailed an evidence-based, theory-driven direct-to-consumer educational brochure, highlighting the potential benefits and harms of opioids when used to treat chronic non-cancer pain.
15932465|NCT03400371|Other|Blood draw|Participation includes one visit for one blood draw per recruited patient. 10-20ml peripheral venous blood will be taken from the antecubital fossa. The DNA from the blood sample will then be extracted and resequenced for analysis.
15932466|NCT03400371|Other|Existing samples|Control DNA samples will be used that have been previously acquired in other studies.
15932467|NCT03400358|Other|uterocervical angle|the angle between cervical canal and anterior uterine wall is measured sonographically.
15932468|NCT03400332|Drug|BMS-986253|Specified dose on specified days
15932469|NCT03400332|Biological|Nivolumab|Specified dose on specified days
15932470|NCT03400332|Biological|Ipilimumab|Specified dose on specified days
15932471|NCT03400332|Other|Placebo|Specified dose on specified days
15932472|NCT03400306|Drug|Veliparib, capsule|capsule; 50 mg or 100 mg
15932473|NCT03400306|Drug|Veliparib, tablet|tablet; 400 mg
15932474|NCT03400306|Drug|Carboplatin|Intravenous
15932475|NCT03400306|Drug|Paclitaxel|Intravenous
15932476|NCT03400293|Other|Functional Assessment of HIV Infection|Functional Assessment of HIV Infection will be used to assess HRQoL of subjects. This will include 47 items.
15932477|NCT03400293|Other|Patient Satisfaction Questionnaire|Patient Satisfaction Questionnaire will be used to assess burden and HRQoL in subjects. This will include 18 items.
15932478|NCT03400293|Other|Symptom Distress Module|Symptom Distress Module will be used to assess burden and HRQoL in subjects. This will include 20 items.
15932479|NCT03400293|Other|Patient Health Questionnaire|Patient Health Questionnaire will be used to assess burden and HRQoL in subjects. This will include 2 items.
15932480|NCT03400293|Other|Internalized Stigma of AIDS Tool|Internalized Stigma of AIDS Tool will be used to assess burden and HRQoL in subjects. This will include 10 items.
15932481|NCT03400293|Other|Medication adherence visual analogue scale|Medication adherence visual analogue scale will be used to assess burden and HRQoL in subjects. This will include 1 item.
15932482|NCT03400280|Other|Best practice algorithm for postoperative care|See arm/group description
15932483|NCT03400267|Drug|Paracetamol|Patients are randomized to paracetamol 1000 mg iv or fentanyl 1-2 mcg/kg with a maximum of 4 mcg/kg iv.
15932484|NCT03400267|Drug|Fentanyl|Patients are randomized to paracetamol 1000 mg iv or fentanyl 1-2 mcg/kg with a maximum of 4 mcg/kg iv.
15932485|NCT03400254|Drug|Hydroxychloroquine (HCQ)|All patients will receive HCQ at a dose of 600 mg orally twice daily. This dose is the same in both phase Ib and phase II portions of the protocol. Capsules of HCQ are available in 200 mg strength, thus patients will initially start with 3 capsules twice daily for a total of 6 capsules per day. HCQ will be administered in divided doses (BID). When taking HCQ twice daily, the two daily doses should be taken 12 hours apart as close to 9am and 9pm as possible. Patients receiving antacids, sucralfate, cholestyramine, and/or bicarbonate should have the HCQ drug dose administered at least 1 hour before or 2 hours after these medications. Hydroxychloroquine will be obtained from the UPENN Investigational Drug Service (IDS).
15932486|NCT03400254|Drug|Gedatolisib|"Gedatolisib will be administered intravenously on a weekly dosing schedule at 150 mg IV.
~Within 3 days prior to GED dosing the patient must have an ANC >1.0 x 109/L and platelet count > 75 x 109/L. If hematologic toxicity persists, treatment should be delayed by one week and the complete blood cell count with differential and platelet count repeated. Treatment may be delayed for up to 4 consecutive weeks (28 days). If after 28 days of delay all hematologic toxicity has still not resolved to normal and non-hematologic toxicity has not resolved to <grade 1 then any further treatment with GED should be stopped."
15932487|NCT03400241|Drug|Tiotropium Bromide Monohydrate|Tiotropium Easyhaler 10 mcg/dose Product A
15932488|NCT03400241|Drug|Tiotropium Bromide Monohydrate|Tiotropium Easyhaler 10 mcg/dose Product B
15932489|NCT03400241|Drug|Tiotropium Bromide Monohydrate|Tiotropium Easyhaler 10 mcg/dose Product C
15932490|NCT03400241|Drug|Tiotropium Bromide Monohydrate|Spiriva 18 Mcg/capsule inhaled via HandiHaler
15932491|NCT03400228|Dietary Supplement|Probiotic|The probiotic is composed of a combination of Lactobacillus acidophilus (LA-5®) and Bifidobacterium lactis (BB-12®).
15932492|NCT03400228|Dietary Supplement|Maltodextrin|Maltodextrin is a supplement feed based carbohydrate powder and tasteless.
15932493|NCT03400215|Diagnostic Test|Diagnostic Breast Cancer Scan|clinically indicated diagnostic breast MRI scans
15932494|NCT03400215|Diagnostic Test|Research Scan for Gradient-echo Spectroscopic Imaging (GSI)|15-min research MRI scan
15932495|NCT03400202|Device|Skin imaging|Non-invasive in vivo skin imaging will be taken with the VivoSight Ox Optical Coherence Tomography (OCT).
15932496|NCT03400202|Other|Facial cleanser|Facial cleanser prior to procedures.
15932497|NCT03400189|Drug|Sulthiame|Single dose (50, 100, 200 mg)
15932498|NCT03400176|Drug|VAY736|Experimental
15932499|NCT03400176|Drug|ibrutinib|Approved medication
15932500|NCT03400163|Drug|BMS-986036|BMS-986036 20 mg QD
15932501|NCT03400163|Drug|Placebo|Placebo QD
15932502|NCT03400150|Device|ProSpace|ProSpace balloon implantation
15932503|NCT03400150|Other|Control|Control - Marking & IMRT are standard of care for prostate cancer - there is no study-specific intervention
15932504|NCT03400137|Diagnostic Test|Increasing of intraocular pressure (IC)|intraocular pressure will be increased using an ophthalmodynanometer
15932505|NCT03400124|Procedure|ISBCS|The intervention group will undergo cataract surgery in both eyes on the same day (ISBCS)
15932506|NCT03400124|Procedure|DSBCS|The usual care / control group will undergo cataract surgery in both eyes on separate days, with a time period of at least two weeks between surgeries.
15932507|NCT03400111|Radiation|low-level laser therapy|low-level laser therapy will be used to relieve pain and discomfort during orthodontic treatment at specific time points.
15932508|NCT03400111|Drug|Panadol-extra|Tablets of 565-mg Panadol-extra will be used at specific time points to control pain and discomfort
15932509|NCT03400098|Drug|Inotersen|Inotersen administered by subcutaneous (SC) injections in the abdomen, thigh, or upper arm
15932510|NCT03400085|Other|mHealth application|The intervention is an mHealth smartphone application designed for living kidney donors to complete their required 2-year follow-up. It allows the donor to input the answers to the clinical survey responses, as well as upload a picture of their lab values.
15932511|NCT03400072|Other|Unsupervised APA program|Exercise training program will consist of one supervised demonstration session with the APA professional, thereafter the training will be continued as unsupervised, home-based exercise training sessions.
15932512|NCT03400072|Other|Supervised APA program|Exercise training program will consist of one supervised demonstration session with the APA professional, thereafter the training will be continued as unsupervised, home-based exercise training sessions; in addition, patients will attend weekly supervised, hospital-based exercise sessions in groups of patients.
15932513|NCT03400059|Device|Chordate System S211 in treatment mode|Chordate System S211 in treatment mode
15932514|NCT03400059|Device|Chordate System S211 in placebo mode|Chordate System S211 in placebo mode
15932515|NCT03400046|Drug|Nutritional Product Supplementation|Patients with chronic intestinal failure were administered nutritional support including enteral and parenteral nutrition.
15932516|NCT03400033|Drug|Daprodustat tablets|Round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.
15932517|NCT03400033|Drug|Matching placebo tablets|Matching placebo to daprodustat tablets supplied as round, biconvex, white, film-coated tablet in unit dose strengths 2 and 4 milligrams (7 millimeter tablets), 6, 8 and 10 milligrams (9 millimeter tablets) administered by the oral route.
15932518|NCT03400033|Drug|Epoetin alfa vials|Single-dose, preservative-free vials in unit dose strengths of 2000, 3000, 4000 and 10,000 Units/milliliter administered by the IV route.
15932519|NCT03400033|Drug|Saline vials or bags|0.9% sodium chloride saline vials or bags administered by the IV route.
15932520|NCT03400020|Other|Ascorbic acid|Ascorbic acid 500 Mg in normal saline IV two hours before the operation and thereafter 500 mg in normal saline IV daily for three days.
15932521|NCT03400020|Other|Normal Saline|Normal saline IV two hours before the operation and thereafter for three days.
15932522|NCT03400007|Device|Dynamic floor magnetic resonance imaging|Dynamic floor magnetic resonance imaging (MRI)
15932523|NCT03400007|Device|Colpocystodefecography|Colpocystodefecography (CCD)
15932524|NCT03399994|Device|device implantation during coronary angioplasty|device implantation during coronary angioplasty
15932525|NCT03399981|Biological|Tysabri|Administered as specified in the treatment arm.
15932526|NCT03399968|Device|ESWT|at low energy, shockwaves are applied non-invasively at the injury level and 5 segments up and down of the spinal cord paravertebrally left and right
15932527|NCT03399968|Device|Placebo ESWT|the ESWT therapy head is positioned at the level of injury and is moved up and down identically as described in the Verum intervention group (ESWT) but without application of shockwaves. The sound which is normally produced by shockwave generation is played by high quality sound recordings in the same amount as in the Verum group
15932528|NCT03399955|Drug|Paromomycin|Paromomycin (20 mg/kg/d) IM for 14 days
15932529|NCT03399955|Drug|Ambisome|AmBisome® (20 mg/kg total dose) IV over 7 days
15932530|NCT03399955|Drug|Miltefosine|Miltefosine oral (allometric dosing) for 42 days (arm 1) or 28 days (arm 2)
15932531|NCT03399942|Procedure|Deep brain Stimulation of cingulum anterior|The Deep brain Stimulation of cingulum anterior is alternatively ON and OFF while Thalamic stimulation is ON
15932532|NCT03399929|Other|Post Acute Rehabiltation|
15932533|NCT03399916|Behavioral|Prompt sent|
15932534|NCT03399903|Drug|Pentasa vs Align|We will examine the safety and possible effectiveness of Pentasa® and Align in reducing markers of immune activation believed to be important reflectors of risk for cardiovascular disease and ongoing immune damage in people with chronic treated HIV-1 infection.
15932535|NCT03399890|Diagnostic Test|Neurological physical exam|Neurological physical exam is performed in all patients at the OR table, immediately after the operation.
15932536|NCT03399877|Biological|Combining electromyography with uroflowmetry (group A)|Children who assigned group A perform uroflowmetry-electromyography for the first and subsequently perform uroflowmetry-electromyography again.
15932537|NCT03399877|Biological|Uroflowmetry(Group B)|Children who assigned Group B perform uroflowmetry-electromyography for the first, and subsequently perform sole uroflowmetry.
15932538|NCT03399877|Biological|Uroflowmetry-Combining electromyography with uroflowmetry (Group C)|Children who assigned Group C firstly perform sole uroflowmetry and subsequently perform uroflowmetry-electromyography.
15932539|NCT03399864|Behavioral|musical training|The subjects in the experimental group will receive weekly 45-minute lessons on musical training for 52 weeks.
15932540|NCT03399864|Other|usual care|The subjects in the control group will receive usual care, such as medical follow-up according to the schedule of the oncology units.
15932541|NCT03399851|Device|Amplatzer Amulet for left atrial appendage closure|The closure of the left atrial appendage (LAAC) is performed percutaneously. Implantation of the Amplatzer Amulet will be performed according to device specific instruction for use, based on both TEE guidance and angiography, femoral venous access and inter-atrial septum crossing.
15932542|NCT03399851|Device|Watchman/FLX for left atrial appendage closure|The closure of the left atrial appendage (LAAC) is performed percutaneously. Implantation of the Watchman/FLX will be performed according to device specific instruction for use, based on both TEE guidance and angiography, femoral venous access and inter-atrial septum crossing.
15932543|NCT03399838|Drug|Dexmedetomidine|IN Dex for pediatric procedural sedation at the emergency department
15932544|NCT03399838|Drug|Midazolam|po/pr midazolam as active comparator to dexmedetomidine for pediatric procedural sedation at the pediatric emergency department
15932545|NCT03399825|Device|OCT-A|"optical coherence tomography angiography
~Imaging with optical coherence tomography angiography"
15932907|NCT03396952|Other|Laboratory Biomarker Analysis|Correlative studies
15932546|NCT03399812|Dietary Supplement|Animal protein|The animal protein intervention is a smoothie containing 40 grams of whey protein isolate.
15932547|NCT03399812|Dietary Supplement|Plant protein|The animal protein intervention is a smoothie containing 40 grams of pea protein isolate.
15932548|NCT03399799|Drug|Talquetamab|Participants will receive IV infusion or SC injection of Talquetamab.
15932549|NCT03399786|Drug|evinacumab|IV administration of evinacumab
15932550|NCT03399786|Drug|Placebo|IV administration of placebo
15932551|NCT03399773|Biological|Omidubicel|Given IV
15932552|NCT03399773|Drug|Cyclophosphamide|Given IV
15932553|NCT03399773|Drug|Fludarabine|Given IV
15932554|NCT03399773|Drug|Thiotepa|Given IV
15932555|NCT03399773|Radiation|Total-Body Irradiation|Undergo TBI
15932556|NCT03399773|Procedure|Umbilical Cord Blood Transplantation|Given IV
15932557|NCT03399773|Other|Laboratory Biomarker Analysis|Correlative studies
15932558|NCT03399760|Biological|i-PRF|i-PRF (injectable platelet rich fibrin) assisted upper canine retraction
15932559|NCT03399760|Procedure|canine retraction|upper canine retraction will be performed in one side of patients with Class II Division 1 malocclusion patients requiring therapeutic extraction of the maxillary first premolars
15932560|NCT03399747|Drug|Abb-R-CHOP|"Completely Excised LocalizedGastrointestinal CD20 (+) Diffuse Large B-cell Lymphoma
~3 Cycles(1 Cycle:4weeks) of Rituximab Plus CHOP (Cyclophosphamide, Adriamycin, Vincristine, and Prednisolone) Immunochemotherapy"
15932561|NCT03399734|Drug|Perampanel|Single oral dose of 1 x 4-mg perampanel tablet
15932562|NCT03399734|Drug|Perampanel|Single 4-mg dose of perampanel fine granules
15932563|NCT03399721|Device|Chordate S101|Active treatment: The controller creates air-mediated kinetic oscillations with regulated pressure and frequency during a preset treatment time
15932564|NCT03399721|Device|Chordate S101 Placebo|Placebo treatment: Placebo treatment is similar to active treatment, but with no oscillations. It is difficult to discern any difference between active and placebo treatment.
15932565|NCT03399708|Drug|Apremilast 30mg|Apremilast will used in line with its license. This includes the standard dose titration scheme (see section 6) and then the usual maintenance dose of 30 mg twice daily orally.
15932566|NCT03399695|Procedure|preoxygenation|spontaneous breathing
15932567|NCT03399682|Diagnostic Test|cystography|observationnal study
15932568|NCT03399669|Drug|gefitinib|Patients will be treated 250 mg/day of gefitinib orally (1 cycle for 28 days). Cycles were repeated until disease progression, unacceptable toxicity, or until the patient or the investigator requested therapy discontinuation.
15932569|NCT03399656|Dietary Supplement|Avmacol tablets|The active components of Avmacol® are ground broccoli seeds that provide glucoraphanin and freeze-dried broccoli sprouts that provide a stabilized form of the enzyme myrosinase, which converts glucoraphanin to sulforaphane.
15932570|NCT03399656|Dietary Supplement|Placebo tablets|MCC 90M Emcocel
15932571|NCT03399643|Drug|Atezolizumab|Atezolizumab is administered via IV 1200 mg every 3 weeks
15932572|NCT03399630|Other|Injection of Autologous Adipose Tissue|Injection of Autologous Adipose Tissue to study the safety and efficacy of treating osteoarthritis
15932573|NCT03399630|Other|Injection of lactated ringers|Injection of placebo lactated ringers to compare against the injection of autologous adipose tissue.
15932574|NCT03399617|Dietary Supplement|Micronutrient Powders|Micronutrient powders (5 nutrient formulation) are currently provided by the Guatemalan Ministry of Health to children between 6-24 months of age.
15932575|NCT03399617|Behavioral|SPOON behavioral change strategy|An innovative behavioral change strategy designed using ethnographic and marketing methods to promote adequate infant and young child feeding practices and the use of SQ-LNS. The strategy will be delivered to mothers or caregivers through individual home-visits, group sessions, and community mobilization activities.
15932576|NCT03399617|Dietary Supplement|SQ-LNS|SQ-LNS is a peanut-based ready to use home fortification product to improve diet quality in children 6-24 months of age. It includes peanuts and other ingredients such as vegetable fat, powdered milk and several micronutrients. The formulation designed for this study does not include sugar.
15932577|NCT03399604|Drug|LIQ861 Inhaled Treprostinil|LIQ861 bulk powder is generated from a treprostinil/excipient matrix from which particles of precise size and shape are created and filled into a hydroxypropyl methylcellulose (HPMC) capsule (size 3). LIQ861 capsules are provided in capsule strengths of 25 μg, 50 μg, 75 μg and 100 μg treprostinil.
15932579|NCT03399552|Drug|Avelumab|10mg/kg delivered by IV infusion
15932580|NCT03399552|Radiation|Stereotactic Body Radiation Therapy|short course of SBRT after the first two doses of avelumab
15932581|NCT03399539|Drug|Dexamethasone|Given PO
15932582|NCT03399539|Drug|Ixazomib Citrate|Given PO
15932583|NCT03399539|Other|Laboratory Biomarker Analysis|Correlative studies
15932584|NCT03399539|Drug|Venetoclax|Given PO
15932585|NCT03399526|Drug|Mapracorat (ZK 245186, BAY 86-5319)|0.1% (1 mg/g) of the active ingredient mapracorat plus excipients as ointment
15932586|NCT03399526|Drug|Prednicarbate 0.25% ointment|0.25% (2.5 mg/g) of the active ingredient prednicarbate as ointment
15932587|NCT03399526|Drug|Clobetasol 0.05% ointment|0.05% (0.5 mg/g) of the active ingredient clobetasol as ointment
15932588|NCT03399526|Drug|Calcipotriene 0.005% ointment|0.005% (0.05 mg/g) of the active ingredient calcipotriene as ointment
15932589|NCT03399526|Drug|Calcipotriene 0.005%/Betamethasone dipropionate 0.05% ointment|0.005% (0.05 mg/g) of the active ingredient calcipotriene/0.05% (0.5 mg/g) of the active ingredient betamethasone dipropionate as ointment
15932592|NCT03399500|Behavioral|In-Person Case Management at Homeless Recovery Program|In-Person Case Management at Homeless Recovery Program
15932593|NCT03399500|Behavioral|Unlimited Smartphone|Smartphone with unlimited calls, texts, and data plan
15932594|NCT03399500|Behavioral|Smartphone Based Case Management (SPCM) app|Smartphone Based Case Management app
15932908|NCT03396952|Biological|Pembrolizumab|Given IV
15932595|NCT03399487|Drug|LDK378(Ceritinib)|"This study is a phase II, single-arm, open label study. All participating patients must sign on the written informed consent form, and a separate form of consent will be used for the use of tissue for the biomarker research.
~This clinical study is targeted for the patients who harbor ROS1 rearrangement and all patients will be treated with LDK378 750mg daily. The treatment period begins on Day 1 of Cycle 1 and 1 cycle consists of 28 days."
15932596|NCT03399474|Drug|Lidocaine Hydrochloride 2%|Lidocaine Hydrochloride 2%
15932597|NCT03399474|Drug|Dexmedetomidine 0.5 ug/kg|pecedex
15932598|NCT03399474|Drug|Dexmedetomidine Injection 0.25 ug/kg|pecedex
15932599|NCT03399461|Other|Patient Interview guide|The interviewer will conduct the interview for subjects with WAS using a semi-structured patient interview guide.
15932600|NCT03399461|Other|Caregiver interview guide|The interviewer will conduct the interview for caregivers of subjects with WAS using a semi-structured caregiver interview guide.
15932601|NCT03399461|Other|Sociodemographic questionnaire|At the end of interview, subjects will be required to complete subject or caregiver versions of country-specific sociodemographic questionnaire.
15932602|NCT03399461|Other|Pediatric quality of life (PedsQL) questionnaire|The PedsQL is a validated generic measure of health-related quality of life (HRQOL) in children, adolescents, and young adults with acute and chronic health conditions. At the end of interview, subjects will be required to complete subject or caregiver versions of PedsQL questionnaire.
15932603|NCT03399461|Other|Clinical questionnaire|At the end of interview, subjects will be required to complete subject or caregiver versions of clinical questionnaire.
15932604|NCT03399448|Biological|NY-ESO-1 redirected autologous T cells with CRISPR edited endogenous TCR and PD-1|Autologous T cells transduced with a lentiviral vector to express NY-ESO-1 and electroporated with CRISPR guide RNA to disrupt expression of endogenous TCRα, TCRβ and PD-1 (NYCE T Cells).
15932605|NCT03399448|Drug|Cyclophosphamide|a cytotoxic chemotherapy agent used for lymphodepletion prior to NYCE T cells.
15932606|NCT03399448|Drug|Fludarabine|a chemotherapy agent used for lymphodepletion prior to NYCE T cells.
15932607|NCT03399448|Device|NY-ESO-1 expression testing|Testing to determine if NY-ESO-1 is expressed on tumor tissue.
15932608|NCT03399435|Combination Product|Neosaxitoxin combined with bupivacaine low and epinephrine (T1)|A single injection: Neosaxitoxin from 1.25 to 60 µg. Bupivacaine 40 mg. Epinephrine 100 µg.
15932609|NCT03399435|Combination Product|Bupivacaine low combined with epinephrine (C1)|A single injection: Bupivacaine 40 mg. Epinephrine dose 100 µg.
15932610|NCT03399435|Combination Product|Bupivacaine high combined with epinephrine (C2)|A single injection: Bupivacaine 100 mg. Epinephrine 100 µg.
15932611|NCT03399435|Combination Product|Neosaxitoxin combined with bupivacaine low (T2)|A single injection: Neosaxitoxin from 1.25 to 60 μg. Bupivacaine from 10 to 80 mg.
15932612|NCT03399435|Drug|Bupivacaine low (C3)|A single injection: Bupivacaine from 10 to 80 mg.
15932613|NCT03399435|Drug|Bupivacaine high (C4)|A single injection: Bupivacaine 100 mg.
15932614|NCT03399435|Drug|Neosaxitoxin (T3)|A single injection: Neosaxitoxin will be between 1.25 and 60 µg.
15932615|NCT03399435|Combination Product|Neosaxitoxin combined with epinephrine (T4)|A single injection: Neosaxitoxin will be between 1.25 and 60 μg. Epinephrine 100 µg.
15932616|NCT03399435|Combination Product|Neosaxitoxin combined with bupivacaine low and epinephrine|A single injection: Neosaxitoxin will be between 1.25 to 60 µg. Bupivacaine dose based on results from Part B (10 to 80 mg). Epinephrine 100 µg.
15932617|NCT03399435|Combination Product|Neosaxitoxin combined with bupivacaine low|A single injection: Neosaxitoxin will be between 1.25 to 60 μg. Bupivacaine dose based on results from Part B (10 to 80 mg).
15932618|NCT03399422|Biological|i-PRF|i-PRF (injectable platelet rich fibrin) assisted upper canine retraction
15932619|NCT03399422|Procedure|canine retraction|upper canine retraction will be performed in one side of patients with Class II Division 1 malocclusion patients requiring therapeutic extraction of the maxillary first premolars
15932620|NCT03399409|Behavioral|Motivational Interviewing|Motivation techniques
15932621|NCT03399409|Behavioral|Anti-inflammatory Information|Provision of information on anti-inflammatory products
15932622|NCT03399396|Behavioral|Practice facilitation for HPV vaccine|The practice facilitation intervention provides coaching support to pediatric practices to guide them through quality improvement projects to increase HPV vaccination rates.
15932623|NCT03399383|Other|Patient education|Participation in the standardized education program (90min patient education). During sessions of 90-120 minutes duration, patients are educated in basic knowledge on adrenal insufficiency including the correct behaviour in emergency settings. Participants are provided with emergency cards and sets and are trained in self-injection of glucocorticoids.
15932624|NCT03399370|Drug|Inclisiran Sodium|Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
15932625|NCT03399370|Drug|Placebo|Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).
15932626|NCT03399357|Biological|Influenza Vaccine|Inactivated Trivalent Influenza Vaccine (IIV3) 2017 containing: A (H1N1): an A/Michigan/45/2015 (H1N1) - like virus (new strain); A (H3N2): an A/Hong Kong/4801/2014 (H3N2) - like virus; B/Brisbane/60/2008 - like virus
15932627|NCT03399344|Other|MRI|In addition to the standard diagnostic work-up patients will receive an additional MRI scan 0-21 days prior to their scheduled surgery.
15932628|NCT03399331|Dietary Supplement|Manuka honey|5 for children or 10cc of honey for adults was ordered directly from a New Zealand company
15932629|NCT03399331|Dietary Supplement|olive oil|5 cc of extra virgin olive oil for adults and 2 cc for children directly from a local distributor in south Lebanon will be given.
15932630|NCT03399331|Combination Product|Control group|Control at our institution is 5cc sodium bicarbonate, 5cc rinsidin and 5cc of mycostatin 4 times daily for children. For adults it is Caphosol in the BMT unit and in the Basile inpatient unit it is the magic solution (without xylocaine).
15932631|NCT03399318|Drug|Acetaminophen|30 mg/kg load then 15mg/kg
15932632|NCT03399318|Drug|Ibuprofen|10 mg/kg
15932633|NCT03399318|Drug|placebo for acetaminophen|placebo for acetaminophen
15932634|NCT03399318|Drug|placebo for ibuprofen|placebo for ibuprofen
15932635|NCT03399292|Drug|Cationorm MD sine eye drops|studyparticipants receive lipidbased eye drops once only in the study eye
15932963|NCT03396549|Device|real tDCS|1 ch TCT transcranial stimulator
15932636|NCT03399279|Procedure|Open flap debridment|Full mucoperiosteal flap reflected+ Debridement of infrabony defect
15932637|NCT03399279|Other|Perforated collagen membrane|Membrane perforations using dental needle
15932638|NCT03399279|Other|Occlusive membrane|Biotech collagen membrane
15932639|NCT03399279|Other|Nanohydroxyapetite|Nanbone Particles
15932640|NCT03399266|Device|Double Balloon catheter for induction of labor|With the patient in lithotomy position or lying supine in bed, a speculum is inserted to visualise the cervix. The device is inserted into the cervix using long forceps until both balloons enter the cervical canal. Then, the uterine balloon is inflated with 20 ml of saline (by means of a 20 ml syringe). The device is then pulled out until stopped by the uterine balloon covering the internal cervical os. At this point the cervico-vaginal balloon located at the external os is inflated with 20 ml of saline and the speculum is removed. Then both balloons are additionally inflated with alternate increments of 20 ml normal saline to a total volume of 80 ml in each balloon. The device is loosely taped to the patient's inner thigh.
15932641|NCT03399253|Procedure|surgery|D2 gastrectomy + metastasectomy
15932642|NCT03399253|Drug|chemotherapy|capecitabine and oxaliplatin (eight 3-week cycles of oral capecitabine 1000 mg/m² twice daily on days 1-14 plus intravenous oxaliplatin 130 mg/m² on day 1) for 6 months or progress of disease
15932643|NCT03399240|Device|Vitasitiq device|Participant uses Vitastiq device for about 2 months to perform Vitastiq readings every day, preferably in the morning. On day 1, 29 and 57 participants' blood sampling is collected and analysed, and measurements using Vitastiq device are performed.
15932644|NCT03399214|Drug|IOP Injection|T1 and T2
15932645|NCT03399201|Procedure|General anesthesia|induction with the intravenous anesthetic (Propofol) and maintenance with the inhalational anesthetic (Sevoflurane)
15932646|NCT03399201|Procedure|Neuraxial anesthesia|Spinal anesthesia will be applied via the local anesthetic ( Bupivacaine).
15932647|NCT03399201|Diagnostic Test|Spirometer|Pulmonary function will be evaluated via the portable spirometer (MIR Spirodoc, Spirodoc®, Roma, Italy)
15932648|NCT03399188|Procedure|Fecal microbiome transplantation|Fecal microbiota transplantation will be performed through colonoscopy to the IBD patients. Donor feces will be extensively screened for other diseases. Colonoscopy will be done at FMT center of Severance Children's Hospital twice with a month of duration. Recipients will be admitted the day before colonoscopy, and they will be discharged after a day of observation.
15932649|NCT03399175|Drug|Early high-dose corticosteroid and immunosuppressive therapy|Early high-dose corticosteroid and immunosuppressive therapy
15932650|NCT03399162|Behavioral|PREHAB Workshop|PREHAB workshop/education session in the Prevention and Rehabilitation Centre regarding nursing, nutrition, physiotherapy, psychology, and diabetes.
15932651|NCT03399162|Behavioral|PREHAB Exercise Program|An 8-week program that consists of: (1) 2x/week 60-minute supervised exercise sessions; and (2) 3x/week 30-minute home-based exercise sessions.
15932652|NCT03399149|Other|Systematic evaluation by an intensivist|
15932653|NCT03399136|Behavioral|Exercise training|Participants attended center-based exercise sessions three times per week at the research exercise training facility located at the Baltimore VA Medical Center. All exercise training was performed under the supervision of research exercise physiologists. Heart rate (HR) was measured continuously during each session using a Polar HR watch and chest strap allowing for assessment and maintenance of treatment fidelity. Exercise logs included details on exercise type, duration, time in target heart rate zone, blood pressure and perceived intensity during each training session.
15932654|NCT03399123|Other|Tidal volume|After General anesthesia, patients that during volume control mode of mechanical ventilation in experimental group, we take low tidal volume.
15932655|NCT03399110|Drug|Oxaliplatin|oxaliplatin 130 mg/m2
15932656|NCT03399110|Drug|Capecitabine|Capecitabine 1000mg/m2
15932657|NCT03399084|Drug|Ferric carboxymaltose|750 mg/15 mL
15932658|NCT03399071|Drug|FLOT-A|This is a single-arm study with all patients receiving combination FLOT-A
15932659|NCT03399058|Other|Group 1 5+5+5 (Control)|The standard of care in Cambodia is known as the basic health and nutrition service package or 5+5+5. The participants in the first group will be the control group and will only be implementing the standard of care, 5+5+5 package (Group 1).
15932660|NCT03399058|Behavioral|Group 2: 5+5+5 & PDH|The participants in the second group will receive contextualized Hearth messages through on-going PDH programs in addition to the basic standard of care (Group 2).
15932661|NCT03399058|Behavioral|Group 3: 5+5+5 & PDH lite+mHealth|The participants in the third group will receive a PDH lite program and receive follow-up through mobile support phone calls (Group 3).
15932662|NCT03399045|Procedure|9-minute withdrawal|Patients in 9-minute withdrawal group will be carefully observed for 9 minutes during the colonoscopy withdraw
15932663|NCT03399045|Procedure|6-minute withdrawal|Patients in 6-minute withdrawal group will be carefully observed for 6 minutes during the colonoscopy withdraw
15932664|NCT03399032|Drug|Caspofungin|"Each patient will receive: caspofungin i.v. once daily ( 70 mg on the first day, 50 mg on the 2 and 3 day
~Blood samples (3 mL) will be collected 2, 4, 8, 12 and 24 hours after each dose of caspofungin for 3 consecutive days."
15932665|NCT03399019|Drug|Dexmedetomidine|initial loading dose (0.5 ~ 1㎍/kg for 10 minutes) and maintenance infusion (0.2-0.7㎍/kg/hr)
15932666|NCT03399019|Drug|Propofol|continuous infusion (0.75-3mg/kg/hr)
15932667|NCT03399019|Drug|Midazolam|0.05mg/kg bolus injection and if not OAA/S ≤ 3 within 5 minutes, add 0.01mg/kg at intervals of 1~2 minutes
15932668|NCT03399006|Device|2D ultrasound|Trans-abdominal ultrasound examination was performed with the woman placed in a recumbent or semi recumbent position & carried out for measurement of fetal CRL and diagnosis of any major fetal defects
15932669|NCT03399006|Device|Doppler Ultrasound|"measurement of UtA-PI & UtA-RI. A sagittal section of the uterus was obtained For the Doppler studies, and the cervical canal and internal cervical os were identified. The transducer was gently tilted from side to side and color flow mapping was used to identify each UtA along the side of the cervix and uterus at the level of the internal os.
~When three similar consecutive waveforms had been obtained the UtA-PI and UtA-RI were measured, and the mean UtA-PI and UtA-RI of the left and right arteries were calculated."
15932760|NCT03398291|Drug|Standard chemotherapy|Patients continue to receive standard chemotherapy including folinic acid, fluorouracil, irinotecan and oxaliplatin (FOLFIRINOX), gemcitabine plus nab-paclitaxel, or gemcitabine plus S-1
15932670|NCT03399006|Device|3D ultrasound|"3D transabdominal ultrasound of the Placental volume: the transducer with a full bladder and the transducer placed perpendicular to the placenta to see the entire placenta. The adjustments to 3D placental scan were an angle of 70° and a maximum region of interest that allowed the full placental surface. The external limits of the placenta were defined by the basal plate and the chorionic plate excluding the myometrium. Another acquisition was done, if the quality criteria were not attained.
~After sonography, the placental volume was calculated with 4D View software (GE Healthcare) by a single operator. The calculation was done twice using the same image, and the time spent was recorded. The VOCAL mode with an angle of rotation of 30° was chosen; the axial plane was the reference; and the calipers were placed on either side of the placenta. With 6 planes, it was possible to reconstruct the volume measured in cubic centimeters."
15932671|NCT03398993|Drug|Clomiphene Citrate|50 mg twice daily from3rd day of cycle till 7th day of cycle
15932672|NCT03398993|Drug|Human chorionic gonadotropin|75 IU dail;y from 6th day of cycle till 8th of cycle once daily
15932673|NCT03398993|Device|Endometrial scratch|"The procedure was carried out in preovulatory day (known when dominant follicle reached 18_20 mm in diameter), usually, done around day 14-day of the cycle.
~In the theatre, Patients put in a lithotomy position, sterilization was performed with the presence of good source of light., the procedure was carried out using a thin pipelle tube as follow :- A cuscoe's speculum was inserted into the vagina in order to visualize the cervix.
~Cervix was grasped by vollselum upwards backwards, then pipelle tube passed through the cervix and uterine cavity, then moved up and down to make a single induced scratch two times in the lining endometrium of posterior wall of uterus.
~The procedure took approximately 15minutes to complete"
15932674|NCT03398980|Radiation|survivors treated with CRT|Radiotherapy technology included conventional radiotherapy (CRT) and intensity-modulated radiotherapy (IMRT).
15932675|NCT03398967|Biological|Universal Dual Specificity CD19 and CD20 or CD22 CAR-T Cells|"Biological: Universal Dual Specificity CD19 and CD20 or CD22 CAR-T Cells
~Day 0: 10% of total dose Day 1: 30% of total dose if patient is stable (no significant toxicity) from prior dose. D2: 60% of total dose if patient is stable (no significant toxicity) from prior dose
~Other: Laboratory Biomarker Analysis"
15932676|NCT03398941|Drug|Preoperative Long Period Octreotide Combined With Postoperative Short Period Octreotide|Long-Period Octreotide 20mg one week before operation combine Short Period Octreotide 0.3mg during postoperative five days.
15932677|NCT03398928|Other|Acupuncture|Acupuncture added to usual care
15932678|NCT03398915|Procedure|Transpedicular Instrumentation|Transpedicular screw placement and instrumentation
15932679|NCT03398902|Behavioral|Sleep extension|Based on CBTI principles, the instructor will prescribe bed times and wake times each week to allow for gradual increases in sleep opportunity.
15932680|NCT03398902|Other|Habitual sleep|The study team member will monitor and encourage participants to keep bedtimes and wake times that matched their baseline bedtimes and wake times.
15932681|NCT03398889|Diagnostic Test|Plasma levels of metabolites|plasma levels of metabolites
15932682|NCT03398889|Behavioral|Dietary questionnaire|Harvard food frequency questionnaire
15932683|NCT03398889|Diagnostic Test|Intestinal microbiome|amplification and sequencing of 16S rRNA gene variable regions in stool samples
15932684|NCT03398876|Drug|Oromucosal Nicotine Spray (ONS)|Participants will receive oral dose of oromucosal nicotine spray (ONS).
15932685|NCT03398876|Drug|Nicotine Gum|Participants will chew nicotine gum for 30 minutes.
15932686|NCT03398876|Other|Cigarette|Participants will smoke one cigarette as 10 puffs for 3 minutes.
15932687|NCT03398863|Procedure|Cleaning of uterine cavity|Procedure: Cleaning the uterine cavity These participants will have their uterine cavities cleaned with a dry laparotomy sponge after delivery of the placenta. Per standard protocol, the uterus will be explored with one hand holding a sponge to remove any remaining membranes or placental tissue, while the other hand is placed on the fundus to stabilize the uterus
15932688|NCT03398837|Drug|Lenabasum 5 mg|Subjects will receive lenabasum 5 mg twice daily.
15932689|NCT03398837|Drug|Lenabasum 20 mg|Subjects will receive lenabasum 20 mg twice daily.
15932690|NCT03398837|Other|Placebo oral capsule|Subjects will receive placebo twice daily.
15932691|NCT03398824|Drug|metformin HCl|Receive metformin HCl
15932692|NCT03398811|Drug|Depot medroxy-progesterone acetate|Injection every 3 months
15932693|NCT03398811|Drug|Etonogestrel|68 mg implant
15932694|NCT03398811|Drug|Desogestrel 75 µg|one pill every day for 28 days without pill-free interval.
15932695|NCT03398798|Device|".014"|".014 CuNiTi orthodontic arch wire"
15932696|NCT03398798|Device|".016"|".016 CuNiTi orthodontic arch wire"
15932697|NCT03398798|Device|Twin brackets|Ormco Insignia Metal Twin brackets
15932698|NCT03398798|Device|Self-ligating brackets|Ormco Insignia SL brackets
15932699|NCT03398785|Procedure|Endovascular chemical Ablation of Adrenal Gland|Patients in this group will be treated with partial ablation of adrenal gland by endovascular injection of dehydrated alcohol.
15932700|NCT03398772|Behavioral|Comprehensive Health Coaching Program|Comprehensive Health Coaching Program: included physical activity and motivational interviewing techniques, participants were encouraged to set goals with decision-making, self-management and self-monitor their progress, and received support from researcher.
15932701|NCT03398759|Drug|Butorphanol|IV injection during induction
15932702|NCT03398759|Drug|Placebos|IV injection during induction
15932703|NCT03398746|Procedure|LOOP Technique|Placement of subcutaneous loop drain
15932704|NCT03398746|Procedure|Standard incision and drainage|Incise and drain with placement of packing
15932705|NCT03398733|Device|continuous positive airway pressure|The CPAP treatment group received both baseline and CPAP treatment for 7 days preoperatively. The non-CPAP treatment group only received baseline treatment.
15932706|NCT03398720|Drug|HTI-1066 dose level 1|Starting dose level
15932707|NCT03398720|Drug|HTI-1066 dose level 2|2nd dose level
15932708|NCT03398720|Drug|HTI-1066 dose level 3|3rd dose level
15932709|NCT03398720|Drug|HTI-1066 dose level 4|4th dose level
15932761|NCT03398278|Drug|Oxycodone Tamper Resistant|Orally taking Oxycodone Tamper Resistant 40mg in fast state
15932762|NCT03398278|Drug|OXYCONTIN®|Orally taking OXYCONTIN® 40mg in fast state
15932997|NCT03396315|Drug|Alendronate|oral alendronate 70 mg weekly for 12 months will be given for the prevention of osteoporosis
15932710|NCT03398694|Procedure|Radiosurgery|"Stereotactic radiosurgery will be delivered on all patients utilizing gamma knife or linear accelerator based techniques as per RTOG-9005 dosing criteria (Section 11 Table 1) based on tumor diameter with the exception that the largest lesion diameter to be treated with 15 Gy will be 5 cm. All apparent, previously untreated brain metastases will be treated with radiosurgery at this time.
~Radiosurgery will be performed 1-4 days prior to surgical resection. Vital signs and MRI Brain planning scan will be performed on the day of radiosurgery prior to the procedure."
15932711|NCT03398681|Drug|Ferric carboymaltose|Ferric Carboxymaltose solution [Ferinject® (FCM), Vifor Pharma (Glattbrugg, Switzerland)]
15932712|NCT03398681|Drug|Placebo (Normal saline)|Normal saline (0.9% weight/volume (w/v) NaCl)
15932713|NCT03398681|Diagnostic Test|Cardiac magnetic resonance|Cardiac magnetic resonance including T2* and T1-mapping sequences
15932714|NCT03398668|Device|Relievion device- Treatment stimulation|1 Hour self-administered treatment specific occipital and supraorbital transcutaneous nerve stimulation
15932715|NCT03398668|Device|Relievion Device- Sham stimulation|1 Hour self-administered sham occipital and supraorbital transcutaneous nerve stimulation
15932716|NCT03398655|Drug|VB-111 + Paclitaxel|VB-111 will be administered intravenously at a dose of 1x10e13 VPs every 2 months Paclitaxel will be administered intravenously at a dose of 80mg/m2 every week
15932717|NCT03398655|Drug|Placebo + Paclitaxel|Placebo will be administered intravenously every 2 months Paclitaxel will be administered intravenously at a dose of 80mg/m2 every week
15932718|NCT03398642|Behavioral|French Lifestyle Redesign|Lifestyle Redesign® is a preventive occupational therapy intervention designed to promote meaningful and healthy activities. The French-Canadian Lifestyle Redesign® intervention was led by an occupational therapist (OT) who took the University of Southern California 6-hour online introductory training course and was supervised on a weekly basis. Weekly 2-hour group sessions were held over a six-month period.These sessions were based on 12 modules (e.g. occupation, health and aging; transportation and occupation) from the 2nd edition of the Lifestyle Redesign® Manual and involved didactic presentations, peer exchanges, reflective exercises, direct experience and personal exploration. Every month, one group outing was targeted and individual meetings with the OT were planned.
15932719|NCT03398603|Procedure|blood sample and ultrasound|When included in the study blood samples and ultrasound are taken every second day of the first and third menstrual cycle after inclusion.
15932720|NCT03398590|Behavioral|self-regulation theory-based mHealth behavior intervention|Participants will receive a self-regulation theory-based mHealth behavior intervention (5 biweekly group sessions, 60 minutes /session). An experienced Certified Diabetes Educator from the Joslin Diabetes Center and PI (Dr. Zheng) who has been trained using self-regulation for weight loss will co-facilitate group sessions. The intervention combines diet modification and increased physical activity with a weekly weight loss goal as well as focuses on improving participants' three typical self-regulation strategies - self-monitoring, self-evaluation and self-reinforcement. Intervention duration will last 2 months with subsequent 1-month follow.
15932721|NCT03398577|Drug|Dapagliflozin 10 MG [Farxiga]|Computer based randomization software will be used in order to randomize eligible consenting subjects to placebo or Dapagliflozin 10 mg treatment using a 1:2 ratio.
15932722|NCT03398577|Drug|Placebo Oral Tablet|Computer based randomization software will be used in order to randomize eligible consenting subjects to placebo or Dapagliflozin 10 mg treatment using a 1:2 ratio.
15932723|NCT03398564|Procedure|Erector Spinae Plan Block|The trocar site incision was done 15 minutes after the block in the three groups. The skin was disinfected with chlorhexidine solution, and the high-frequency transducer was isolated with a sterile disposable plastic cover and gel. The patient was placed in lateral position. A high-frequency linear ultrasound probe was placed longitudinally lateral to the T8 spinous process by 3 cm. After identification of the 3 muscles superficial to the hyperechoic transverse process shadow as follows: trapezius, rhomboid major, and erector spinae. The needle was introduced in a cephalo-caudal orientation. The needle tip was positioned fascial plane between rhomboid major and erector spinae muscles. Hydrodissection by 1-2 ml of normal saline to visualize the plan, then deposition of local anesthetic was done. A total of 20 mL of 0.25% bupivacaine was injected here. The same procedure was repeated on the other side.
15932724|NCT03398564|Procedure|Oblique subcostal TAP|ultrasound-guided bilateral oblique subcostal TAP block with bupivacaine 0.25% (20ml on each side)
15932725|NCT03398538|Other|Offloading|Patient will be offloaded in a diabetic camboot after treatment, or total contact cast if patient cannot be fit with diabetic offloading boot
15932726|NCT03398538|Other|Additional (outer) Dressing Application|Application of outer a moisture retentive dressing, and a multi-layer compression dressing.
15932727|NCT03398538|Other|Mirragen Wound Matrix Dressing|Application of Mirragen to wound site along with standard of care treatment
15932728|NCT03398538|Other|Fibracol Wound Dressing|Application of Fibracol Alginate along with standard of care treatment
15932729|NCT03398525|Other|usual care|usual care following local standard operational procedures
15932730|NCT03398525|Other|Musical intervention|Musical intervention using a marketed music program validated for music therapy
15932731|NCT03398512|Procedure|exploratory laparoscopy or laparotomy|Exploratory laparoscopy or laparotomy, for PCI score or radical colorectal resection and cytoreductive surgery
15932732|NCT03398512|Procedure|HIPEC|Normal saline 3000ml-4000ml, Raltitrexed 4mg, 43°C, 60min.
15932733|NCT03398512|Drug|Systemic chemotherapy|Oxaliplatin: 130mg/m2, day 1. Capecitabine: 1500mg, twice daily for two weeks, and then suspend for one week
15932734|NCT03398499|Device|VIOFOR (Med & Life)|Device: VIOFOR (Med & Life) Magnetic-light applicators, generating a slow-changing electromagnetic field and light ener-gy (830 nm and 640 nm), emitted from LEDs during a physiotherapeutic treatment application parameters: frequency of basic field pulses: 180-195 Hz frequency of packet the field pulses: 12.5 Hz-29 Hz magnetic induction: 15 μT wavelength of light: 830 nm and 640 nm Duration: 10 min number of treatments: 10
15932735|NCT03398486|Diagnostic Test|Kinesiotaping|Dynamic adhesive taping is a method that involves the application of specific tapes to the surface of the patient's skin in order to use the natural self-healing processes of the body. It is often used as an element that sustains the therapeutic effect. Its action is based mainly on the action normalizing muscle tone, supporting the work of joints, improving the function of weakened muscles, increasing microcirculation at the site of application.
15933105|NCT03395405|Other|Placebo|One tablet twice daily with food for 56 consecutive doses
15932736|NCT03398486|Diagnostic Test|inactivation of trigger points (TrP)|A procedure for releasing trigger points using physiotherapy using the ischemic compression method, which involves applying pressure to the active trigger point, until it is switched off, i.e. pain ceases.The location of the trigger point is done palpatively, with a pliers grip, covering the strained tissue on the inside and outside of the cheek with the thumb and index finger.
15932737|NCT03398473|Drug|Epoetin Hospira SDV|Epoetin Hospira Single Dose Vial
15932738|NCT03398473|Drug|Epoetin Hospira MDV|Epoetin Hospira Multi-Dose Vial
15932739|NCT03398460|Diagnostic Test|Survey|Burnout rates before and after the introduction of a bereavement card Burnout rates before and after an ICU rotation for physicians
15932740|NCT03398434|Drug|MAA868|3 MAA868 doses, single administration, subcutaneous,
15932741|NCT03398434|Drug|Apixaban|Apixaban 5 mg b.i.d
15932742|NCT03398421|Drug|Nemiralisib|Nemiralisib will be given as 100 mcg via ELLIPTA Dry Powder Inhaler with 30 doses per inhaler/ 100 mcg total dose. ELLIPTA® is a registered trademark of GlaxoSmithKline group of companies.
15932743|NCT03398421|Drug|Itraconazole|Itraconazole will be given as 100 mg per capsule per day administered orally with water
15932744|NCT03398408|Behavioral|Training|The intervention group will be provided with the cognitive training module and participants will be required to complete a targeted 36-minute daily training for 35 days.
15932745|NCT03398395|Procedure|endocrown restoration|a cervical margin in the form of a butt joint and a preparation of the pulp chamber that does not extend into the root canals.
15932746|NCT03398395|Procedure|90° shoulder endocrown restoration|a 90°cervical margin in the form of a butt joint and a preparation of the pulp chamber that does not extend into the root canals.
15932747|NCT03398382|Dietary Supplement|Magnesium tablet group|Before the anaesthesia, all principles of surgical sterility and asepsis with oral cavity flushing for 1 min. ( 15 ml. 0.12% CHX.) will be performed. Operative side will be anaesthetized with the same anaesthetic 3M ESPE, Ubistesin-artikain. The surgeon, assistant, surgical approach, surgery technique and instruments will be the same in all subjects. For one side which will be randomly selected, the patient will receive magnesium citrate tablets. The same analgesics will also be prescribed: Ibuprofen tbl 400 mg which will be taken as needed, and magnesium citrate tablets. 200 mg. After the surgery, all patients will be given the same written and oral instructions for postoperative care.
15932748|NCT03398382|Dietary Supplement|Placebo tablets group|Before the anaesthesia, all principles of surgical sterility and asepsis with oral cavity flushing for 1 min. ( 15 ml. 0.12% CHX.) will be performed. Operative side will be anaesthetized with the same anaesthetic 3M ESPE, Ubistesin-articain. The surgeon, assistant, surgical approach, surgery technique and instruments will be the same in all subjects. For one side which will be randomly selected , the patient will receive placebo tablets which will be identical to the right drug. The same analgesics will also be prescribed: Ibuprofen tbl 400 mg which will be taken as needed, and placebo tablets. 200 mg. After the surgery, all patients will be given the same written and oral instructions for postoperative care.
15932749|NCT03398382|Dietary Supplement|Magnesium lozenge group|Before the anaesthesia, all principles of surgical sterility and asepsis with oral cavity flushing for 1 min. ( 15 ml. 0.12% CHX..) will be performed. Operative side will be anaesthetized with the same anaesthetic 3M ESPE, Ubistesin-articain. The surgeon, assistant, surgical approach, surgery technique and instruments will be the same in all subjects. For one side which will be randomly selected patient will receive magnesium citrate lozenge.The same analgesics will also be prescribed: Ibuprofen tbl 400 mg which will be taken as needed, and magnesium citrate lozenges. 100 mg. After the surgery, all patients will be given the same written and oral instructions for postoperative care.
15932750|NCT03398382|Dietary Supplement|Placebo lozenges group|Before the anaesthesia, all principles of surgical sterility and asepsis with oral cavity flushing for 1 min. ( 15 ml. 0.12% CHX.) will be performed. Operative side will be anaesthetized with the same anaesthetic 3M ESPE, Ubistesin-articain. The surgeon, assistant, surgical approach, surgery technique and instruments will be the same in all subjects. For one side which will be randomly selected patient will receive placebo lozenges which will be identical to the right drug. The same analgesics will also be prescribed: Ibuprofen tbl 400 mg which will be taken as needed, and placebo lozenges 100 mg. After the surgery, all patients will be given the same written and oral instructions for postoperative care.
15932751|NCT03398369|Diagnostic Test|CMR/CTA Guidance for CRT|The intervention is the use of CMR and CTA to determine the optimal pacing site in the left ventricle for cardiac resynchronization therapy (CRT) and guide left ventricular lead placement.
15932752|NCT03398356|Drug|Metformin|"for group A: 12 weeks metformin treatment in a final dose 3 x 500 mg
~for group B: 3 weeks metformin treatment in a dose 3 x 500 mg, next: 3 weeks metformin treatment in a final dose 3 x 1000mg, next: 3 weeks metformin treatment in a dose 3 x 500 mg."
15932753|NCT03398330|Drug|Oxycodone Tamper Resistant|Orally taking Oxycodone Tamper Resistant 40mg in fed state
15932754|NCT03398330|Drug|OxyContin®|Orally taking OXYCONTIN® 40mg in fed state
15932755|NCT03398317|Other|PICSI|sperm selection using PICSI dish for selecting sperm with lower DNA fragmentation index
15932756|NCT03398317|Other|MACS|sperm selection using MACS for selecting sperm with lower DNA fragmentation index
15932757|NCT03398304|Other|Graded Exercise|Study arm 1 (Graded Exercise) participants will complete either 20 minutes of mild or moderate intensity at 2 different study visits. The third study visit will consist of 20 minutes of sitting.
15932758|NCT03398304|Other|Marathon participation|Study arm 2 (Marathon participation) participants will take part in a marathon. On the day of the marathon prior to start, the participant will be seated for 10 minutes prior to measuring their baseline heart rate. A 4.5 mL blood sample will be collected prior to initiation of exercise. Immediately after completion of the marathon, a 4.5 mL blood draw will be completed. Additional 4.5 mL blood draws will be taken at 1 and 2 days post-marathon to measure to length of time required to return to baseline coagulation, fibrinolysis, and inflammation following the prolonged, intense exercise.
15932759|NCT03398291|Procedure|Synchronous resection of primary pancreatic cancer and liver oligometastasis|Patients undergo surgical exploration. If no extensive metastatic sites are found, the synchronous resection of primary pancreatic cancer and liver metastatic sites will be performed. Adjuvant chemotherapy was recommended, and the regimen selection is recommended to be based on the preoperative chemotherapy.
15932797|NCT03398031|Drug|Placebo Oral Tablet|After biochemical diagnosis of pregnancy each participant will receive placebo tablet once daily till the end of the 1st trimester
15932763|NCT03398265|Behavioral|Treatment Navigation (Intervention)|Subjects in the intervention arm will begin a discussion with the interventionist about whether they are interested in treatment and medication choices for opioid use disorder. The interventionist will use a decision tool informed by the Substance Abuse and Mental Health Services Administration (SAMSHA) guide to medication assisted treatment in order to help make an informed decision about treatment choices. Once a decision is reached, the Treatment Navigator will communicate with the subject periodically to assist with entering treatment and help with locating other social services as needed within the community. The Treatment Navigator will emphasize getting into treatment as quickly as possible once a decision is made. The Treatment Navigator and the subject will continue communicating throughout the 6 month study period. Subjects will also receive overdose education and be offered take-home naloxone.
15932764|NCT03398265|Other|Control|Subjects in the control arm will receive referrals from Department of Corrections (DOC) staff for treatment per DOC protocols. Subjects will not receive any treatment navigation or treatment decision making. Subjects will also receive overdose education and be offered take-home naloxone.
15932765|NCT03398252|Drug|Doxazosin XL|Participants will be randomized to receive increasing doses of doxazosin XL (0, 4, and 8 mg).
15932766|NCT03398252|Drug|Placebo|Participants will be randomized to receive a placebo for doxazosin XL.
15932767|NCT03398239|Device|Noninvasive mechanical ventilation|
15932768|NCT03398213|Other|Acupuncture|Acupuncture
15932769|NCT03398213|Other|Sham procedure|Ear stimulation with plaster
15932770|NCT03398200|Biological|Hyperbaric Oxygen Therapy|The intervention consists of exposure to hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours, in a single see-through hyperbaric chamber, breathing 100% oxygen for 90 minutes while subjects are resting in supine position. During the 2 hours, there will be compression and decompression phases for 15 minutes each in which subjects will be breathing compressed environmental air (21% oxygen).
15932771|NCT03398200|Other|No Hyperbaric Oxygen Therapy|The reference arm will not receive hyperbaric oxygen therapy prior to hematopoietic stem cell transplant.
15932772|NCT03398187|Device|cardiac catheterization|diagnostic and interventional cardiac catheterization
15932773|NCT03398174|Behavioral|Motor Control Exercise|"Exercise aiming at improving function of specific muscles of the lumbopelvic region and the control of posture and movement.
~In addition, participants will perform stretching exercises aiming at targeting the postural muscles and connective tissue around the lower back, pelvis and lower limb that tend to get shortened in chronic LBP, and they will be advised to perform aerobic exercise in the form of overground walking at desirable speed at home."
15932774|NCT03398174|Behavioral|Patient Education|"Patient education to enable patients to better understand their pain, change any unhelpful beliefs about LBP, and integrate self-management and active coping strategies that deals with fear avoidance behavior and catastrophic thought.
~In addition, participants will perform stretching exercises aiming at targeting the postural muscles and connective tissue around the lower back, pelvis and lower limb that tend to get shortened in chronic LBP, and they will be advised to perform aerobic exercise in the form of overground walking at desirable speed at home."
15932775|NCT03398161|Other|Quality-of-Life Assessment|Ancillary studies
15932776|NCT03398161|Other|Questionnaire Administration|Ancillary studies
15932777|NCT03398161|Radiation|Radiation Therapy|Undergo ultra low dose radiation therapy
15932781|NCT03398135|Drug|risankizumab|subcutaneous (SC) injection
15932782|NCT03398135|Drug|placebo for risankizumab|subcutaneous (SC) injection
15932783|NCT03398122|Procedure|TACE|epirubicin 30-60mg was injected into the blood supply artery of the tumor ,Embolization was subsequently performed with granules of gelatin sponge particles.
15932784|NCT03398122|Drug|Apatinib|a molecular targeted anti-tumor drugs,small molecule vascular endothelial growth factor receptor 2 inhibitor
15932785|NCT03398109|Device|Customized toric IOL for post-DALK atigmatism|
15932786|NCT03398096|Device|Cardiac shock wave therapy|Ultrasound guided cardiac shock wave therapy (CSWT) is a new treatment method offering an alternative to revascularization by stimulating angiogenesis. Subsequent clinical trials showed that CSWT could reduce symptoms of myocardial ischemia and improve cardiac function in patients with severe coronary artery disease.
15932787|NCT03398083|Drug|THC|THC capsule
15932788|NCT03398083|Drug|Alprazolam|Alpraxolam capsule
15932789|NCT03398083|Drug|Placebo oral capsule|Sugar pill capsule
15932790|NCT03398083|Drug|CBD|CBD capsule
15932791|NCT03398070|Other|Standard of Care|"The standard of care interventions for Functional Neurological Disorders (FND) include:
~delivery of a rule-in diagnosis
~providing educational materials
~referring to physical therapy (PT) and/or occupational therapy (OT) as clinically indicated
~referring to FND-related cognitive behavioral therapy (CBT)
~psychotropic medication management based on standard psychiatric care"
15932792|NCT03398057|Other|Health education|SHEP included a comprehensive lecture about BC, with a generally deep focus on detection and screening tools, which were illustrated by a PowerPoint presentation with pictures and videos. The program also included a practical session about BSE (on breast silicon model). At the end of SHEP, a focused group discussion was conducted to answer participants' questions, and to discuss important barriers regarding BSE practice and visiting primary health care centers or clinics to undergo CBE and mammography. Different scientific and administrative solutions were discussed. SHEP materials were distributed as a hard copy (booklet) and in electronic format (CD) for all participants in the health education group at the end of training.
15932793|NCT03398057|Other|Control group|Placebo health education (pamphlets) will be applied to this group participants during study.
15932794|NCT03398044|Drug|Dexamethasone|Dexamethasone will be administered to patients randomised into the active treatment arm, in order to determine the influence upon PONV incidence.
15932795|NCT03398044|Drug|Placebo|Placebo will be administered to patients randomised into the control group arm.
15932796|NCT03398031|Drug|Magnesium Oxide|After biochemical diagnosis of pregnancy each participant will receive magnesium plus 500 mg tablet once daily till the end of the 1st trimester
15932798|NCT03398018|Drug|repository corticotropin injection|80 units twice per week as a subcutaneous injection
15932801|NCT03397992|Other|Changing dialysate temperature|Patients had SLED with low dialysate temperature (around 35°C) compared with high dialysate temperature (around 37°C)
15932802|NCT03397979|Behavioral|Infrequent versus Frequent Soaking Baths|Submersion of skin, affected by atopic dermatitis, in a bathtub filled with luke-warm water, where the frequency and duration of these baths are varied, to look for any differential effect.
15932803|NCT03397966|Drug|recombinant human BNP (1-32)|Subjects will receive an IV infusion of recombinant human BNP1-32 (6 mcg BNP/ml saline) for 240 minutes.
15932804|NCT03397966|Drug|normal saline (placebo)|Subjects will receive an IV infusion of normal saline for 240 minutes.
15932805|NCT03397953|Drug|Vinorelbine|Vinorelbine will be used 25mg/m2/week, rest for 1 week after 3 weeks of continuous use, 4 weeks will be a course. After 1 week there will be a simple assessment, after 2 weeks will be a comprehensive assessment. If the patient got disease progression or partial response/stable disease, he/she would be removed from this trial.
15932806|NCT03397927|Device|orthosis|
15932807|NCT03397914|Drug|Colistimethate Sodium|Intravenous injection of colistimethate Sodium 2.5 mg/kg or 5 mg/kg for Multidrug-resistance gram negative infections
15932808|NCT03397901|Procedure|Transverse colostomy|Transverse double-cavity colostomy
15932809|NCT03397888|Drug|Betrixaban|80 mg capsule
15932810|NCT03397875|Procedure|Zinc oxide based sealer|After root canal treatment obturation will be done using zinc oxide eugenol based sealer.
15932811|NCT03397875|Procedure|Epoxy resin based sealer|After root canal treatment obturation will be done using epoxy resin based sealer.
15932812|NCT03397875|Procedure|Bioactive silicone based sealer|
15932813|NCT03397862|Drug|Donepezil TDS|Donepezil patch
15932814|NCT03397862|Drug|Vehicle TDS|Placebo patch
15932815|NCT03397849|Behavioral|Intervention using mobile technology|Each study patients that are randomized to IMT plus usual care group will receive a group of smart devices including mobile phone (Vestel Venus e2) (Vestel, Manisa, Turkey), wristband (Xiaomi band 2) (Beijing Xiaomi Technology Co., Beijing, China), weight scale (Bluecat, Yongkang Tiansheng Electronic Co., Zhejiang, China) and blood pressure monitor (Clever Chek TD-3250) (TaiDoc Technology Co., Taipei County, Taiwan)
15932816|NCT03397836|Other|Health TAPESTRY Intervention|The patient will receive in-home visits from trained volunteers who will collect information electronically using a tablet computer. The volunteers will collect information about the client's health goals, health risks, and needs using a specifically designed application (TAP-App). Once the data is gathered, it is summarized into a report (TAP-report) which is securely and electronically sent to the health care clinic (TAP huddle). The team can leverage clinic supports and/or community supports as they deem appropriate to help clients reach their health goals and address any needs and risks which were reported during the volunteer visits.
15932817|NCT03397836|Other|Usual Care|Usual care while waiting for the Health TAPESTRY intervention, the control group will receive usual care from their healthcare providers.
15932818|NCT03397810|Radiation|low dose radiotherapy|10 Gy in 5 fractions of 2 Gy on 5 consecutive days
15932819|NCT03397797|Drug|Rocuronium|In the group to need the eletrophysiological monitoring during the operation, we don't inject muscle relaxant except anestheitic induction.
15932820|NCT03397771|Drug|Litoxetine|oral study medication provided in a dose titration manner
15932821|NCT03397771|Drug|placebo|placebo medication provided in a dose titration manner
15932822|NCT03397758|Device|Study population|First, periorbital area was treated with the short needles (exposure time 150ms, power 9W) to tighten the overlying dermis. Then, the fat pocket itself was treated additionally with the long needle (exposure time 400ms, power 9W).
15932823|NCT03397745|Device|BIS|All patients applied BIS on both side (Left and Right)
15932824|NCT03397732|Procedure|aorto-bifemoral bypass and aorta stentgraft|Surgical implantation of aorto-bifemoral bypass or aorta stentgraft under general and/or regional anaesthesia.
15932827|NCT03397706|Drug|VRx-3996|Taken orally once or twice daily
15932828|NCT03397706|Drug|Valganciclovir|Taken orally once or twice daily
15932829|NCT03397680|Diagnostic Test|13C Urea Breath Test|After the H.pylori eradication treatment course completed, participants then was tested with 13C Urea Breath Test to confirm treatment effectiveness at least after ceasing PPI and antibiotics for 4 weeks.
15932830|NCT03397667|Other|ABC ANSWERS|Primary Care plus ABC ANSWERS
15932831|NCT03397667|Other|Control|Primary Care as usual
15932832|NCT03397654|Drug|Pembrolizumab|Pembrolizumab solution
15932833|NCT03397654|Combination Product|Trans-arterial chemoembolization|Doxorubicin injected through the hepatic blood supply directly to the cancer-affected part of the liver, then gelatin sponge particles injected to block the blood vessels supplying the tumour
15932834|NCT03397641|Drug|HBI-3000|Small molecule, multi-ion channel blocker
15932835|NCT03397641|Other|Placebo|Normal Saline
15932836|NCT03397628|Other|FIFA 11 for health|
15932837|NCT03397615|Behavioral|Betadine douches|subjects received a vaginal preparation with povidone-iodine solution immediately prior to caesarean delivery
15932838|NCT03397602|Behavioral|standard care + moderate-intensity continuous exercise training|Participants will attend on-site moderate-intensity continuous exercise training two times weekly for 12 weeks.
15932839|NCT03397602|Behavioral|standard care + high-intensity interval training|Participants will attend on-site high-intensity interval training two times weekly for 12 weeks.
15932840|NCT03397589|Behavioral|Community Health Worker (CHW) services|CHWs are non-clinical people who provide education, care coordination, and support to families.
15932841|NCT03397576|Behavioral|ATHENA|Adherence Through Home Education and Nursing Assessment (ATHENA), is an evidence-based ART adherence intervention delivered in the patient's home by nurses and peer educators working in teams.
15932842|NCT03397563|Device|Continuous Positive Airway Pressure|standard automatic CPAP machine set on optimal automatic pressure
15932843|NCT03397563|Device|sham Continuous Positive Airway Pressure|CPAP machine with pressure set below effective impact, i.e. low pressure of 4 cm H2O and adjustment of the ventilation mask
15932844|NCT03397550|Other|salt restriction education|Salt intake target：<5g/d Method：the standard salt restriction education will be lasting for 10-15 minutes by oral explanation at baseline.
15932845|NCT03397537|Drug|Letrozole 2.5Mg Tablet|letrozole 2.5mg p.o.qd
15932846|NCT03397537|Drug|GnRH analogue|3.75 mg triptorelin im. q28d
15932847|NCT03397524|Other|optima4BP|optima4BP will provide the treating physician with a treatment action recommendation for consideration.
15932848|NCT03397511|Behavioral|Financial Incentives|Baseline Interview, 2 Counseling Sessions at baseline and 2 weeks post baseline, and one follow up survey at one month
15932849|NCT03397498|Behavioral|CogniFit™|The program utilizes 21 tasks, which may develop 14 cognitive domains: awareness, inhibition, spatial perception, visual short term memory, working memory, hand-eye coordination, visual scanning, response time, divided attention, time estimation, visual perception, shifting, naming, and planning.
15932850|NCT03397498|Behavioral|Control-games|The program utilizes classic computer games, which may develop cognitive domains. Games will be used over 8 weeks. The participants will use the program 3 days a week, with one rest day between each session. Each session lasts approximately 20 minutes. The participant will use the program for a total number of 24 sessions.
15932851|NCT03397485|Dietary Supplement|Growing milk|Intervention Milk powder was prepared and reconstituted every weekday at each day-care center according to WHO and Day Care guidelines. Trained personnel prepared the milk according to the color-coding assigned to each child. Bottles were used to facilitate measuring in milliliters. Each bottle was weighted before and after preparing milk in a diet measuring scale (OHOUSE, model CS5000, capacity 5000gx2g).Each children received an individual bottle or cup with its own milk (240ml). Once each bottle or cup was prepared it was given to the child. After the child finished drinking the milk, leftovers were weighted and recorded.
15932852|NCT03397485|Dietary Supplement|Fortified milk|Intervention Milk powder was prepared and reconstituted every weekday at each day-care center according to WHO and Day Care guidelines. Trained personnel prepared the milk according to the color-coding assigned to each child. Bottles were used to facilitate measuring in milliliters. Each bottle was weighted before and after preparing milk in a diet measuring scale (OHOUSE, model CS5000, capacity 5000gx2g).Each children received an individual bottle or cup with its own milk (240ml). Once each bottle or cup was prepared it was given to the child. After the child finished drinking the milk, leftovers were weighted and recorded.
15932853|NCT03397472|Device|magnetic field modulation device|use the device with magnetic field modulation to treat insomnia
15932854|NCT03397472|Device|placebo device|use the sleep pillow without magnetic field modulation treatment
15932855|NCT03397459|Diagnostic Test|Spine teleradiography EOS|
15932856|NCT03397446|Drug|Lisdexamfetamine dimesylate|50mg or 70mg oral capsules taken once-daily for to 2 months. The trial will begin with a 4-week titration phase, where patients will titrate up to a dose of 50mg/day or 70mg/day, followed by a 4-week maintenance phase. No dose changes will be permitted during the maintenance phase.
15932857|NCT03397433|Other|Information Technology physician assist|The intervention hospitals will have a progress note placed in the electronic health record by a reviewing Infectious Disease specialist that comments on the initial antibiotic choice. The comment is based on an electronic prediction tool (Information Technology physician assist) as to what the best therapy is for the individual patient whose health record is reviewed.
15932858|NCT03397420|Other|FAM-CARE|Family-centered care, where all HIV-positive family members are seen together as a unit and receive HIV care and treatment services together, for HIV-positive children and their caregivers
15932859|NCT03397407|Other|No intervention|
15932860|NCT03397394|Drug|Rucaparib|Rucaparib will be administered daily.
15932861|NCT03397368|Diagnostic Test|Transperineal Ultrasound -|Every women with stress incontinence witll be subjected to urodynamics to confirm genuine stress incontinence then will be subjected Transperineal US
15932862|NCT03397342|Device|CPAP machine|Use of CPAP machine during MRI
15932863|NCT03397329|Drug|AG-348 Sequence A|"Treatment Period 1 Single 50 mg dose of AG-348 administered as a capsule formulation (2 × 25 mg capsules)
~Washout Period 7 days
~Treatment Period 2 Single 50 mg dose of AG-348 administered as a tablet formulation (1 × 50 mg tablet)"
15932864|NCT03397329|Drug|AG-348 Sequence B|"Treatment Period 1 Single 50 mg dose of AG-348 administered as a tablet formulation (1 × 50 mg tablet)
~Washout Period 7 days
~Treatment Period 2 Single 50 mg dose of AG-348 administered as a capsule formulation (2 × 25 mg capsules)"
15932865|NCT03397316|Procedure|xenograft placement .|immediate implant placement in upper esthetic zone with xenograft placement between residual labial bone and implant surface.
15932866|NCT03397303|Other|elastography measurements|elastography measurements
15932867|NCT03397290|Device|Ultrasound (US) Imaging|Ultrasound (US) Imaging will be compared to the chest X-ray for diagnostic accuracy (sensitivity and specificity) in diagnoses of pneumothorax post transthoracic lung biopsy
15932868|NCT03397277|Behavioral|Safety behaviour promoting video|A 7 min. video which teaches 15 different safety behaviours to reduce violence or the effect of violence
15932869|NCT03397277|Behavioral|Control video|A 7 min. video which teaches women about safety regarding food, alcohol, smoking, medication and physical activity during pregnancy
15932870|NCT03397264|Biological|Aflibercept|Intravitreal injection
15932871|NCT03397264|Biological|OPT-302|Intravitreal Injection
15932872|NCT03397264|Other|Sham intravitreal injection|Sham (mock) intravitreal injection
15932873|NCT03397251|Device|AMDS|The device will be implanted during an already planned surgical intervention for aortic dissection repair. The participant will be observed and data gathered during the surgery and routine standard of care follow up visits.
15932874|NCT03397225|Behavioral|Lifestyle intervention|The educational sessions and individual sessions including dietary management and physical activity advices.
15932875|NCT03397212|Other|NADA acupuncture|Ear acupuncture protocol described by National Acupuncture Detoxification Association
15932876|NCT03397212|Other|Sham acupuncture|Ear acupuncture using inactive sham points
15932877|NCT03397199|Drug|Apatinib + S-1|Apatinib 250mg/d,q.d.,p.o. A course of treatment need 21days. S-1 40-60mg（40mg bid BSA <1.4, 60mg bid BSA>1.4），bid,from day1-day 14.
15932878|NCT03397186|Procedure|Biopsy|Undergo biopsy
15932879|NCT03397186|Other|Laboratory Biomarker Analysis|Correlative studies
15932880|NCT03397186|Drug|Trabectedin|Given as standard of care
15932881|NCT03397173|Drug|Azacitidine|Azacitidine will be administered intravenously or subcutaneously at a fixed dose of 75mg/m2/day for 7 consecutive days, allowing interruptions for weekends and holidays within each 28-day cycle. No dose modifications will be permitted during the treatment period.
15932882|NCT03397173|Drug|Ascorbic acid|Ascorbic acid will be administered orally daily at 1 g/day three days prior to start azacitidine and then continues daily for a total of 28 days of each 28 day cycle. No dose modifications will be permitted during the treatment period.
15932883|NCT03397160|Behavioral|Decision Support Intervention (DSI)|"A question list (QL) that includes areas of patient concern are created by the health coach for use by the patient and the urologist at their first consultation visit where they discuss the extent of their cancer and consider treatment options. The coach uses the Prostate Cancer SCOPED model to complete a Prostate Cancer SCOPED Model Form. The SCOPED model uses concepts such as the situation, choices (treatment), objectives (personal goals and priorities), people (involved in supporting a treatment decision), evaluation and decisions (clarifying which choice is best and next steps)."
15932884|NCT03397147|Behavioral|Sleep Coach Jr.|A brief sleep education program for parents of school-aged children with type 1 diabetes, with a focus on resolving sleep disturbances with parent education and positive bedtime routines.
15932885|NCT03397134|Drug|Placebo Oral Tablet|Placebo administered as a single dose once daily
15932886|NCT03397134|Drug|Roluperidone 32 mg|Roluperidone administered as a single dose once daily
15932887|NCT03397134|Drug|Roluperidone 64 mg|Roluperidone administered as a single dose once daily
15932888|NCT03397121|Drug|Inclisiran|Inclisiran is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis.
15932889|NCT03397121|Drug|Placebo|Placebo will be supplied as sterile normal saline (0.9% sodium chloride in water for injection).
15932890|NCT03397095|Combination Product|CSWT+BMMSCs|All participants will screened by D-SPECT to assess the myocardium viability. If the viable myocardium is detected, Patients will be randomized to receive cardiac shock wave therapy with an equipment (Modulith SLC; Storz Medical, Switzerland) followed the recommended protocol developed by Tohoku University of Japan and the protocol developed by the University of Essen, Germany. An over-the-wire catheter will be positioned in the target coronary artery and the cells resuspended in saline will be injected intracoronary.
15932891|NCT03397095|Device|CSWT+Sham operation|Patients randomized to this group will receive a routine cardiac shock wave therapy and coronary angiography. No cells will be administered via the coronary artery.
15932892|NCT03397082|Drug|Lidocaine gel|5mL of lidocaine gel applied topically to cervix previous to clamping and paracervical blockade.
15932893|NCT03397082|Drug|Placebo|5mL of sterile gel applied topically to cervix previous to clamping and paracervical blockade.
15932894|NCT03397069|Procedure|Peribulbar block (control)|"The Peribulbar block was performed by inserting the needle percutaneously at the area bounded by 1- The imaginary perpendicular line joining inferior lacrimal papilla to the inferior margin of the orbit, laterally 2- Lateral border of the nose, medially 3- Inferior lacrimal canaliculus, superiorly and 4- Inferior orbital margin, inferiorly. The needle was introduced in an anteroposterior direction to its half-length and then in an oblique direction to the optical foramen.
~After negative aspiration, 6-8 ml of local anesthetic solution (lidocaine 2%, hyaluronidase 15 IU / ml ) was injected slowly over about 40 seconds or until the appearance of lid fullness. This was followed by a gentle digital massage to the eyeball to facilitate diffusion of the local anesthetic mixture."
15932895|NCT03397069|Procedure|Peribulbar block(M1)|"The Peribulbar block was performed by inserting the needle percutaneously at the area bounded by 1- The imaginary perpendicular line joining inferior lacrimal papilla to the inferior margin of the orbit, laterally 2- Lateral border of the nose, medially 3- Inferior lacrimal canaliculus, superiorly and 4- Inferior orbital margin, inferiorly. The needle was introduced in an anteroposterior direction to its half-length and then in an oblique direction to the optical foramen.
~After negative aspiration, 6-8 ml of local anesthetic solution (lidocaine 2%, hyaluronidase 15 IU / ml. plus midazolam 50 µg/ml ) was injected slowly over about 40 seconds or until the appearance of lid fullness. This was followed by a gentle digital massage to the eyeball to facilitate diffusion of the local anesthetic mixture."
15932896|NCT03397069|Procedure|Peribulbar block(M2)|"The Peribulbar block was performed by inserting the needle percutaneously at the area bounded by 1- The imaginary perpendicular line joining inferior lacrimal papilla to the inferior margin of the orbit, laterally 2- Lateral border of the nose, medially 3- Inferior lacrimal canaliculus, superiorly and 4- Inferior orbital margin, inferiorly. The needle was introduced in an anteroposterior direction to its half-length and then in an oblique direction to the optical foramen.
~After negative aspiration, 6-8 ml of local anesthetic solution (lidocaine 2%, hyaluronidase 15 IU / ml. plus midazolam 100 µg/ml ) was injected slowly over about 40 seconds or until the appearance of lid fullness. This was followed by a gentle digital massage to the eyeball to facilitate diffusion of the local anesthetic mixture."
15932897|NCT03397056|Other|Questionnaire|The Questionnaire is provided in the links at the end of the declaration.
15932898|NCT03397043|Other|Protein intake (dose)|Protein intake, in the form of crystalline amino acids, will range between 0.2-3.0 g/kg/d
15932899|NCT03397030|Other|Home-Based Exercise Program|The intervention will include a combination of both aerobic and body-weight based exercises. The aerobic portion of the intervention will include 5 days of light to moderate intensity walking for 30 mins. Intensity will be set at 40-60% of the individual's heart rate reserve. The body-weight based exercises will be done 3 times a week and will consist of 3 sets of 15 reps of bodyweight squats, incline push-ups, and hip thrusts. If these exercises cannot be performed, lower intensity exercises such as sit-to-stand, wall push up and pelvic tilt can be replaced. Individuals in this group will be given a pocket guide with instructions on how to safely perform the exercises and document their completion.
15932900|NCT03397017|Other|Transfusion|
15932901|NCT03397004|Drug|Doxycycline Hyclate|Doxycycline will be given for 6 months, followed by a washout period for 6 months (pre or post a crossover intervention)
15932902|NCT03397004|Drug|Placebo|Placebo will be given for 6 months, followed by a washout period for 6 months (pre or post a crossover intervention)
15932903|NCT03396978|Other|GnRHag|Ovarian Hormone Suppression - the purpose of the intervention is not to study the drug, but the impact of the loss of ovarian hormones.
15932904|NCT03396965|Other|Mini-c-arm|Fluoroscopy used to aid reduction of distal radius fracture
15932905|NCT03396952|Drug|Aspirin|Given PO
15932906|NCT03396952|Biological|Ipilimumab|Given IV
15932909|NCT03396939|Device|Orthosis|All participants in the experimental group will be given an orthotic device for a 12-week period to use alongside their functional goal- and task-oriented training program.
15932910|NCT03396926|Biological|Bevacizumab|Given IV
15932911|NCT03396926|Drug|Capecitabine|Given PO
15932912|NCT03396926|Other|Laboratory Biomarker Analysis|Correlative studies
15932913|NCT03396926|Biological|Pembrolizumab|Given IV
15932914|NCT03396913|Device|IPL|Intense pulsed light (IPL) is a non-invasive and non-laser light treatment that is FDA-approved for various conditions in dermatology. Subjects will receive a total of 4 IPL treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications of 10-15 IPL pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression.
15932915|NCT03396913|Device|Sham IPL|Sham intense pulsed light (IPL) will be implemented with an IPL device in which all light is blocked by a filter. Subjects will receive a total of 4 sham treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications of10-15 sham pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression.
15932916|NCT03396913|Procedure|MGX|Meibomian gland expression (MGX) will be implemented by squeezing the meibomian glands with the aid of two Q-tips positioned on either side of the meibomian glands, or with a meibomian gland expressor forceps
15932917|NCT03396900|Drug|RhBMP-2 Protein, Recombinant|Bone morphogenetic proteins (BMPs) are a category of proteins that are involved in bone formation and repair. Among these, BMP-2 is one of the most potent members of the BMP family and has been used for correcting intrabony, supraalveolar, furcation, and fenestration defects due to its osteoinductive property. BMP's are also essential for differentiation of osteoclasts, but their role in this process remains unclear. Treatment of osteoclasts with exogenous BMP-2 directly enhances RANKL-stimulated differentiation of osteoclast precursors in vitro and stimulates survival and resorptive activity of mature osteoclasts that accelerates the tooth movement.
15932918|NCT03396900|Other|Conventional Corticotomy|A conventional PAOO Surgical procedure will be performed for individuals in this arm
15932919|NCT03396887|Other|U Control Drink Smartphone Application|The smartphone application comprises five recovery focused features: supportive messages, Computerised-Cognitive Behavioural Therapy, a drinking log, craving management and gamification.
15932920|NCT03396887|Other|Control group|The control group will receive treatment as usual.
15932921|NCT03396874|Drug|68Ga-PSMA|"PET/CT imaging with 68Ga-PSMA:
~68Ga-PSMA is an investigational radioactive drug that binds to receptors on prostate cancer cells. The intravenously administered drug dose will be about 5 mCi (range 3-7 mCi)."
15932922|NCT03396861|Drug|Aflibercept|Subconjunctival aflibercept
15932923|NCT03396848|Other|SHAReClinic|Online clinic with educational modules
15932924|NCT03396835|Device|INVSENSOR00009|All subjects who are enrolled into the test group and participate in data collection receive both the INVSENSOR00009 and the control sensor simultaneously on the forehead.
15932925|NCT03396822|Drug|Gadoteridol|gadolinium MRI contrast
15932926|NCT03396809|Device|Punctal plug|Punctal plugs are FDA approved for the treatment of dry eye. They increase lubrication of the eye by blocking the drainage of tears into the lacrimal sac. The nose portion of the plug has a larger diameter which is designed to fit in the canaliculum in order to retain the plug in the punctum. The plugs will be used on-label, as it is FDA approved in the treatment of dry eye. The purpose of punctal plugs are to increase tear volume by preventing drainage of tears into the lacrimal sac. The plugs are removable if necessary. Investigators are not testing this device for effectiveness or safety.
15932927|NCT03396796|Procedure|Vagus nerve-preserving group|The modified vagus nerve-preserving procedure was performed in the following order: (1) left gastroepiploic vein along greater curvature; (2) the posterior surface of stomach, including the posterior gastric veins; (3) the left lateral surface of the distal esophagus; (4) the left inferior phrenic veins; (5) the posterior surface of the distal esophagus;(6) the anterior surface of the distal esophagus; and (7) the right lateral surface of the distal esophagus. The hepatogastric ligament was conserved. the adherent junction between visceral peritoneum and the right crural diaphragm, and divided it into the lesser omental sac. The left gastric artery and vein and the posterior gastric veins were transected en bloc using a linear laparoscopic vascular stapler.
15932928|NCT03396783|Biological|blood test|during the visit, nurse will make a blood test for biological and immunological analysis
15932929|NCT03396783|Other|electromyogram and walk test|during the visit, measuring the amount of functional motor units at the muscular level and the distance traveled during a 2 minute walk
15932930|NCT03396770|Procedure|Standard clinical routine|Patient management is carried out according to the usual service protocol
15932931|NCT03396770|Procedure|Nephrocheck test|"Nephrocheck® test is realized 4 hours after the end of the cardiopulmonary bypass
~If the test is positive, hemodynamic evaluation is carried out and adapted therapy to result of this evaluation is initiated.
~If the test is negative, patient management is carried out according to the usual protocol.
~A second test is realized 6 hours after the first test whatever the result of it."
15932932|NCT03396757|Procedure|Standard strategy|"RRT is initiated within 12 hours after documentation of serum urea concentration >40 mmol/l and/or an oliguria/anuria for more than 72 hours. The timing of its initiation will be recorded and RRT will continue until criteria for cessation are observed. This arm corresponds to the delayed strategy in the published AKIKI trial (NEJM 2016),"
15932933|NCT03396757|Procedure|Delayed strategy|"RRT will be initiated only if one or more of above-mentioned potentially severe situations occur (identical to those used during the observational study) or if serum urea concentration reaches 50 mmol/L (this level being chosen in order to avoid extreme elevations of serum urea levels as mentioned above). The physician in charge will be allowed to try a medical treatment. Patients will not receive RRT whatever the duration of anuria/oliguria if any above-mentioned indication for RRT is not present. When required, RRT will be performed with the same modalities and stopped according to the same criteria as in the no further delayed RRT strategy, with special care to avoid dialysis disequilibrium syndrome (see below).
~The decision to initiate RRT in the delayed strategy arm of the trial will have to be approved by the attending physician(s) involved in patient's care in order to make sure that it corresponds to her/his usual practice."
15932934|NCT03396744|Device|Light|Placebo light (50 Lux) during 1 week and then active bright light with glasses using a dosage escalation (inter- and intra-subject) of 7.5, 10, 15, 30 and 45 min
15967365|NCT03132103|Radiation|Solar simulated radiation (SSR)|
15932935|NCT03396731|Device|geko™ medical device|The geko™ device, manufactured by Firstkind Ltd (High Wycombe, United Kingdom), is a small disposable, battery powered CE marked medical device.
15932936|NCT03396718|Radiation|De-escalation radio(chemo)therapy - Level 1|54/ 59,4 Gy
15932937|NCT03396718|Radiation|De-escalation radio(chemo)therapy - Level 2|48,8/ 55 Gy
15932938|NCT03396718|Radiation|Standard radio(chemotherapy)|60/ 66 Gy
15932939|NCT03396705|Procedure|Liver Biopsy|liver tissue will be collected via core biopsy during liver resection surgery and post-operatively by fine needle aspiration biosy
15932940|NCT03396692|Procedure|Intravenous morphine patient-controlled analgesia (PCA)|"Group 1 control:
~Morphine titration at 0.1 mg/kg
~Establishment of PCA morphine:
~concentration 1mg/ml
~1ml bolus
~refractory period of 7 minutes
~no maximum dose per day. Premedication of the patient with Ketamine 0.15 mg/kg and Propofol 0.5 mg /kg"
15932941|NCT03396692|Procedure|Block of the posterior exo-thoracic fascia with Ropivacaine|"Group 2 PEF block:
~Establishment of PCA morphine:
~concentration 1mg / ml
~1ml bolus
~refractory period of 7 minutes
~no maximum dose per day.
~Realization of a block of the posterior exo-thoracic fascia (PEF block) at the median level of ribs fractures with ropivacaine 5mg / mL, 3 mg / kg under echography guidance. ALR needle (type neurostimulation) with a length of 100 mm is used. When the injection is performed an analgesia catheter is deposited in the space created by local anesthetics. Realization of ropivacaine bolus 2mg / ml at 0.1ml/kg every 4 hours. Possibility of an additional bolus of 0.1ml / kg every hour if insufficient analgesia."
15932942|NCT03396692|Procedure|Block of paravertebral space with Ropivacaine|"Group 3 paravertebral block:
~Establishment of PCA morphine:
~concentration 1mg / ml
~1ml bolus
~refractory period of 7 minutes
~no maximum dose per day.
~Realization of a paravertebral block (BPV) at the median level of ribs fractures ropivacaine 5mg / mL, (0.3ml / kg) 1.5 mg / kg under echography guidance. ALR needle (type neurostimulation) with a length of 100 mm is used. When the injection is performed an analgesia catheter is deposited in the space created by local anesthetics. Realization of bolus of ropivacaine 2mg / ml at 0.1ml / kg every 4 hours.
~Possibility of an additional bolus of 0.1ml / kg every hour if insufficient analgesia.
~In the case of failure of initial management with significant pain despite the iterative boli, epidural analgesia is used in recourse."
15932943|NCT03396679|Other|Ultrasound examination|Evaluation of the Psoriatic Arthritis remission according to patient and physician's global assessment of disease activity are in agreement (CASPAR criteria agreement) or in disagreement (CASPAR criteria disagreement)
15932944|NCT03396666|Other|Telemouv|Telemouv telerehabilitation solution Patients will receive telerehabilitation solution during three months
15932945|NCT03396653|Behavioral|Peer-delivered Weight Maintenance|Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month patient-delivered behavioral weight maintenance intervention. Specifically, group sessions will be delivered by a mentor (i.e., successful weight loser) and weekly coaching will be delivered by a peer (other member of their weight maintenance group).
15932946|NCT03396653|Behavioral|Professionally-Delivered Weight Maintenance|Contingent upon participants losing 5% of body weight or more in Phase I (weight loss) of this trial, participants will receive an 18-month reduced intensity behavioral weight maintenance intervention, delivered by a professional. The intervention will consist of 24 group sessions.
15932947|NCT03396640|Procedure|Unicondylar Knee Arthroplasty|"Incision will be midline incision, as with a TKA, for maximum security of blinding.
~Standard operative technique will hereafter be used, with minor individual preferences for each surgeon as to whether tourniquet/not, drain or not."
15932948|NCT03396640|Procedure|Total Knee Arthroplasty|Incision will be midline incision, as standard. Standard operative technique will hereafter be used, with minor individual preferences for each surgeon as to whether tourniquet/not, drain or not.
15932949|NCT03396627|Diagnostic Test|pathological examination|fresh MM specimens from patients undergoing Müllerectomies will undergo histologic examinations
15932950|NCT03396614|Diagnostic Test|CTTC scan, cardiac MRI, ECG, 6 minute walking test, echocardiogram|CTTC scan, cardiac MRI, ECG, 6 minute walking test, echocardiogram
15932951|NCT03396601|Drug|Ketamine Hydrochloride|Ketamine HCl will be infused intravenously at a dose of 0.5 mg/kg over 40 minutes
15932952|NCT03396601|Drug|Placebo|Normal Saline placebo will be infused IV over 40 minutes
15932953|NCT03396588|Drug|Clonidine|1mcg/kg/dose (with a dosing interval of 3 or 4 hours), increases by 25% of initial dose every 12-24 hrs. Decrease by 10% of max dose every 24 hrs.
15932954|NCT03396588|Drug|Morphine|Starting dose is 0.06 mg/kg/dose (every 3 or 4 hours), increases by 25% of initial dose every 12-24 hrs. Decrease by 10% of max dose every 24 hrs.
15932961|NCT03396562|Other|Assessments of Development and Growth|Longitudinal observational assessments of development and growth at ages: 2 months, 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 5 or 6 years.
15932962|NCT03396549|Device|new sham tDCS|1 ch TCT transcranial stimulator
15932964|NCT03396536|Other|Evaluation of KM|"KM will be evaluated. The alveolar mucosa will be stained with Lugol's solution, by means of a cotton swab. A cotton roll will be soaked in the solution and gently applied on the mucosa around the implant. Since Lugol's solution is selective to the glycogen present in AM, the muco-gingival junction as the borderline between the blue-stained alveolar mucosa and KM can be easily identified.
~A manual periodontal probe with 1 mm markings will measure the distance from the peri-implant margin and the muco-gingival junction.
~Mucosal thickness (MT) will be measured after topical application of the anesthetics. MT will be evaluated inserting a 27G needle with a rubber stop 1 mm below the peri-implant mucosal margin at the mid-buccal aspect, until the abutment is engaged. The needle will be removed and the distance between the rubber stop and the point of the needle will be measured with a manual periodontal probe."
15932965|NCT03396523|Drug|Losartan|administration of losartan (50 mg) (oral)
15932966|NCT03396523|Drug|Placebo Oral Tablet|administration of placebo (oral)
15932967|NCT03396510|Other|IMPROVED intervention|Patients randomized to IMPROVED will self-report their symptoms each day using a tablet computer. If any patient refuses or is unable to complete the symptom assessment on the computer, the investigators will permit them to use paper versions. At morning rounds each day, the clinical team will view reports detailing their patients' symptom burden. Patients randomized to IMPROVED will have their symptoms presented to their inpatient oncology team, but the investigators will not provide guidance about what actions to take in response to patients' symptoms.
15932968|NCT03396497|Drug|LYC-55716|Continuous twice daily administration of LYC-55716 in 28 day treatment cycles.
15932969|NCT03396497|Drug|Pembrolizumab|Pembrolizumab administered every 3 weeks as prescribed as standard of care by the investigator in accordance with the package insert.
15932970|NCT03396484|Drug|Methyldopa|Tablet for oral dosing
15932971|NCT03396484|Drug|Placebo|Tablet for oral dosing
15932972|NCT03396471|Drug|Pembrolizumab|200mg IV at day -21, then day 1 of each 21-day cycle for a maximum of 24 continuous months of Pembrolizumab (35 cycles) from C1D1 can be administered.
15932973|NCT03396471|Radiation|External Beam Radiation Therapy|20-30 Gy over five fractions for up to two cycles.
15932974|NCT03396458|Diagnostic Test|Hepatitis B serology|A serum specimen will be taken and assessed for hepatitis B serology (HBsAg, anti-HBs and anti-HBc).
15932975|NCT03396458|Other|Questionnaire|Participants will be asked to fill in a questionnaire regarding sociodemographic factors, migration history, risk factors for HBV infection (e.g. sharing toothbrushes, HBV infected family member) and HBV vaccination status.
15932981|NCT03396432|Device|Video Laryngoscopy for ET placement|Tracheal intubation performed with the Storz C-Mac Video Laryngoscope
15932982|NCT03396432|Device|Direct Laryngoscopy for ET Placement|Tracheal Intubation performed with the Miller Blade
15932983|NCT03396406|Device|Pulsed radiofrequency (PRF)|received PRF at 42°C for 8 minutes followed by CRF at 60°C for 270s
15932984|NCT03396406|Device|thermocoagulation|received sole CRF at 70°C for 270 s
15932985|NCT03396393|Drug|Dihydroartemisinin tablet|DHA tablet
15932986|NCT03396393|Drug|Placebo tablet|Placebo tablet
15932987|NCT03396380|Drug|Vitamin D with calcium and clomiphene citrate|"Vitamin D ( ossofortin®, EVA PHARMA) 10000 IU twice weekly and calcium (calciprex®, Marcyrl Pharmaceutical Industries ) 1250 mg twice daily which provide elemental calcium 500 mg/tablet for one month before induction of ovulation and both will be continued during the 3 induction cycles in the same regimen.
~Induction of ovulation by clomiphene citrate (Clomid®, Aventis) 50 mg tablet twice daily 12 hours apart (total dose 100 mg daily) starting from the third day of menstrual cycle and for five days ."
15932988|NCT03396380|Drug|Placebo Oral Tablet with calcium and clomiphene citrate|"The placebo tablet twice weekly and calcium (calciprex®, Marcyrl Pharmaceutical Industries ) 1250 mg twice daily which provide elemental calcium 500 mg/tablet for one month before induction of ovulation and both will be continued during the 3 induction cycles in the same regimen.
~induction of ovulation by clomiphene citrate (Clomid®, Aventis) 50 mg tablet twice daily 12 hours apart (total dose 100 mg daily)starting from the 3rd day of menstrual cycle and for five days"
15932989|NCT03396367|Behavioral|PARTNER|The PATRNER intervention addresses, drug use, PrEP uptake/adherence, and HIV transmission risk by enhancing communication skills by integrating motivational interviewing and video-based communication skills training.
15932990|NCT03396367|Behavioral|Education Intervention|The Education intervention consists of a 4-session health education intervention that addresses sexual risk and substance use through a lecture and question and answer format.
15932991|NCT03396354|Procedure|Integrated robotic surgery|Robotic gastrectomy using Single-Site and Firefly technology will be performed. Specifically, two-port surgery using the Single-Site port and an independent trocar along the right flank (for harmonic scalpel) will be used, along with peritumoral injection of indocyanine green via endoscopy the day before surgery to completely visualize the entire lymphatic channel.
15932992|NCT03396354|Procedure|Conventional laparoscopic surgery|conventional laparoscopic gastrectomy will be performed.
15932993|NCT03396341|Other|Salvia sample|salvia sample
15932994|NCT03396341|Behavioral|Questionnaires|Participants will complete Assessment #1 questionnaires. Participants will be contacted 1 week later (+/- 1 week) to complete Assessment #2 questionnaires. Participants will be contacted 6 months (+/- 3 weeks) following the receipt of their genetic risk modifier results to complete Assessment #3 questionnaires. Participants will be encouraged to complete Assessments #2 and #3 via email using the secure, approved REDCap system
15932995|NCT03396328|Behavioral|conventional low salt education|conventional low salt education
15932996|NCT03396328|Behavioral|Intensive low salt dietary education by smartphone application|Participants are provided with information on food and recipe, which allows them to record daily meals in their applications. Through the mobile application, the participants receive information on daily salt intake. Based on this information, the clinical nutritionist coach sets a goal for low salt diet and provides feedback to the patients through the mobile application. The clinical nutritionist coach checks the activity of the user more than twice a week and sends in-app messages to maintain compliance.
15933107|NCT03395392|Drug|Lurasidone HCl|Lurasidone HCl will be given twice a day by mouth
15932998|NCT03396315|Drug|Zoledronic Acid|single intravenous dose of zoledronic acid 5 mg will be given for the prevention of osteoporosis
15932999|NCT03396302|Other|Educational intervention|The self-applied on-line intervention will comprise a three months behavioural intervention composed by 8 modules seeking to develop gradually achieving the goals of changing eating and physical activity habits.
15933000|NCT03396289|Other|Conventional physiotherapy including balance exercises|Programme will include balance exercises with balance board and swiss ball, weight shifting exercises on board, one-legged balance, balance on unstable surface, balance on tilting surface and balance with Biodex Balance System. Biodex Balance System Biodex will only be used during sessions under physiotherapist supervision.
15933001|NCT03396289|Other|Inspiratory muscle training|Threshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure.
15933002|NCT03396276|Drug|Suboxone|8mg of buprenorphine/2mg of naloxone
15933003|NCT03396276|Behavioral|Brief counseling in the ED|"Patients will receive brief counseling from ED physician prior to discharge about the options for outpatient treatment, as well as opioid dependency.Consented patients will be provided with a pamphlet from the Substance Abuse and Mental Health Services Administration called Facts About Buprenorphine, as well as an information packet for study contact information for the opioid recovery network providers."
15933004|NCT03396276|Behavioral|Referral to outpatient treatment|A referral will be made to one of the affiliated MAT clinics.
15933005|NCT03396276|Behavioral|Follow-up coaching|A designated paramedic with the Houston Fire Department (called the navigator or care coordinator) will work with UTHealth to jointly follow-up on patients both telephonically and in-person. The Houston Fire Department paramedic will provide brief information sharing and assist with coordination in scheduling or registering with MAT clinics or recovery coaching.
15933006|NCT03396263|Behavioral|Non-personalised advice|Provision of online non-personalised advice on dietary intake, weight and physical activity levels. Non-personalised dietary advice for improved food choice based on standard population health guidelines.
15933007|NCT03396263|Behavioral|Online personalised advice|Provision of online personalised advice on dietary intake, weight and physical activity levels. Personalised recommendations for improved food choice based on adherence to an 11-item modified US Alternative Healthy Eating Index (m-AHEI), for weight based on ideal BMI range and for physical activity based on the Baecke questionnaire/results.
15933008|NCT03396263|Behavioral|Face-to-face personalised advice|Provision of face-to-face personalised advice on dietary intake, weight and physical activity levels. Personalised recommendations for improved food choice based on adherence to an 11-item modified US Alternative Healthy Eating Index (m-AHEI), for weight based on ideal BMI range and for physical activity based on the Baecke questionnaire/results.
15933009|NCT03396250|Drug|Naproxen sodium and diphenhydramine hydrochloride soft capsules|Single oral administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 capsules)
15933010|NCT03396250|Drug|Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve, PMBAY98-7111)|Single administration of Naproxen sodium 220 mg/DPH HCl 25mg (2 tablets)
15933011|NCT03396211|Drug|Apatinib|Oral daily doses of apatinib (as its mesylate salt)
15933012|NCT03396211|Drug|Nivolumab|Fixed dose of nivolumab given intravenously every 2 weeks
15933013|NCT03396185|Drug|Icotinib|Patients who have EGFR-mutant stage IIIA-IIIB and unresectable lung adenocarcinoma will receive Icotinib with a dose of 125 mg three times per day orally till progressive disease or unaccepted toxicity as consolidation therapy after synchronous or sequential chemoradiotherapy.
15933014|NCT03396172|Other|Control|The hospitalization will take place in the usual setting and the hospital discharge will be decided by pulmonologists according to the usual criteria
15933015|NCT03396172|Device|FreeDom|Early return home, patients using an innovative device that automatically adjusts and wean the oxygen flow (FreeO2 system) coupled to telemedicine and tele-rehabilitation
15933016|NCT03396159|Diagnostic Test|mini fluid challenge|mini fluid challenge will be given to diagnose if patient is need fluid resuscitation or not
15933017|NCT03396146|Other|12 ml total blood tubes volume|12 ml total blood tubes at 0, +60, + 90, + 120 minutes before and after a mixed meal
15933018|NCT03396146|Other|Fecal sample|Fecal sample at inclusion
15933019|NCT03396133|Diagnostic Test|Snap|screen, transmission, and analysis ECG automated
15933020|NCT03396120|Diagnostic Test|Pulmonary function test|forced vital capacity and diffusing capacity
15933021|NCT03396107|Drug|Dexamethasone|Dexamethasone 6mg, IM, 48 hours before cesarean section
15933022|NCT03396107|Drug|Placebo|Placebo 6mg, IM, 48 hours before cesarean section
15933023|NCT03396094|Device|High-flow nasal cannulae (HFNC) oxygenation|Delivery of 60L/min of supplemental oxygen for pre-oxygenation and apnoeic oxygenation during rapid sequence intubation using the AIRVO™ 2 Humidifier with Integrated Flow Generator (Fisher & Paykel Healthcare, Auckland, New Zealand)
15933024|NCT03396094|Device|Non-rebreather mask and standard nasal cannula|Pre-oxygenation using non-rebreather mask and apnoeic oxygenation via nasal cannulae at 15L/min
15933025|NCT03396081|Behavioral|PRADO-IC|"Help of administrative employees to schedule the first medical visits after an hospitalization for heart failure.
~Home nurse's visiting program, during 2 to 6 months after the hospitalization for heart failure."
15933026|NCT03396081|Behavioral|No intervervention Usual Care|Advices about the care pathway, provided by care givers. Prescription of home nurse's visits if needed.
15933027|NCT03396068|Drug|NRX-101|NRX-101, a fixed dose combination of D-cycloserine+lurasidone will be given twice a day by mouth
15933028|NCT03396068|Drug|Lurasidone HCl|Lurasidone HCl will be given twice a day by mouth
15933029|NCT03396055|Other|specific rehabilitation exercise|specific rehabilitation exercise for patients with cervical myelopathy
15933030|NCT03396029|Behavioral|Individually tailored lifestyle feedback|The written, standardized individually tailored lifestyle feedback includes feedback on consumption of fruit, berries and vegetables and alcohol, physical activity, smoking and body mass index.
15933031|NCT03396029|Behavioral|Standard leaflet|The leaflet is The Norwegian Cancer Society's one-page information brochure on healthy lifestyle behaviours for low cancer risk, including non-smoking, healthy body weight, physical activity, diet, moderate alcohol consumption, moderate sun exposure etc.
15933032|NCT03396003|Device|GALILEI G6 Lens Professional|Eight measurements of the eye using the GALILEI G6 Lens Professional will be taken using two different devices and 2 different operators
15933033|NCT03396003|Device|Oculus Pentacam AXL|A single measurement of the eye will be taken using the Oculus Pentacam AXL
15933034|NCT03395990|Procedure|Active comparator: chloroprocaine|15 ml of 2% chloroprocaine was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.
15933035|NCT03395990|Procedure|Sham comparator: saline|15 ml of normal saline was placed under ultrasound guidance adjacent to the femoral nerve in the operative limb.
15933036|NCT03395977|Drug|Placebos|Lactose placebo for pills and saline for perfusion.
15933037|NCT03395977|Drug|Febuxostat|Febuxostat tablet.
15933038|NCT03395977|Drug|Rasburicase|Rasburicase injectable solution.
15933039|NCT03395964|Procedure|Hybrid Dyna-CT guided localization|We will perform intraoperative lung tumor localization in CGMH hybrid operation room(Room 51) equipped with the Siemens Artis Zeego system with DynaCT imaging capabilities. The system provides images equivalent to a 16-slice spiral CT scanner in a single 6-s sweep.
15933040|NCT03395964|Procedure|Preoperative CT scan-guided localization|Preoperative localization of the lung nodule will be carried out in the radiology department on the day of surgery using local anesthesia. CT-guided hook-wire or methyl blue dye will be placed percutaneously through a 22-gauge needle with the distal end deep to the nodule. The patient will then be taken to the operating room, where under general anesthesia with lung isolation, the nodule will be removed by wedge excision with endostaplers (Endo-GIA-II, United States Surgical,Norwalk, Conn; Echelon Endostapler, Ethicon Endo-Surgery, Cincinnati,Ohio) under the guidance of preoperative lung marking. If the lesion could not be excised using the VATS technique, the patient underwent an open thoracotomy.
15933041|NCT03395951|Drug|Diuretics|Observation of hemodynamics during diuretics treatment within clinical indication.
15933042|NCT03395938|Behavioral|Proactive engagement|The engagements would include (1) a sealed envelope containing a cancer information sheet and an invitation letter directed towards siblings for them to contact the research team, (2) weekly phone reminders to the participants for a total of 4 weeks in a bid to remind participants of the need to convey the screening message to their siblings. The envelope will contain information on the various means for the siblings to contact the research team. These include communication means such as electronic mails (emails), telephone, hard copy returned mails through pre-paid envelopes, short messaging services (SMSs) or clinic consult.
15933043|NCT03395938|Behavioral|Current practice|This intervention depicts current practices by having the research team educate the participants on the Ministry of Health Singapore screening guidelines akin to counselling sessions carried out during the patient's clinical consultation. The research team would highlight that we would be happy to assist if necessary. The research team would then contact the patients in 4 weeks to check if they have communicated with their siblings and if they have gone for screening. We would also find out which method did they adopt to communicate with their siblings.
15933044|NCT03395925|Device|Celon Pro Surge|bipolar coagulation electrode intended for tissue heating
15933045|NCT03395912|Drug|Intervention|After closing the fascia above the rectus muscles, and before closing the skin, the subcutaneous layer will be infiltrated on both sides of the incision (top and bottom) by 30 ml of 0.25% BUPIVACAINE and ADRENALIN at 1: 200,000 concentration and then closing the skin.
15933046|NCT03395899|Drug|Atezolizumab|PD-L1 antibody
15933047|NCT03395899|Drug|Cobimetinib|Highly selective small-molecule inhibitor of MEK1 and MEK2
15933048|NCT03395899|Drug|Ipatasertib|Selective, ATP-competitive small molecule inhibitor of all three isoforms of the serine/threonine kinase Akt
15933049|NCT03395899|Drug|Bevacizumab|Highly specific humanized monoclonal antibody that targets VEGF
15933050|NCT03395886|Drug|Remifentanil|The noninvasive ventilation intolerated patients was sedated by remifentanil.
15933051|NCT03395886|Drug|Dexmedetomidine|The noninvasive ventilation intolerated patients was sedated by dexmeditomidine.
15933052|NCT03395873|Drug|Avelumab|"Decitabine 20mg/m2 IV day 1-5, every 28 days
~Avelumab 10mg/kg IV, day 1, every 14 days"
15933053|NCT03395860|Drug|ATG|group A:low dose antithymocyte globulin rATG(2.5mg/kg/d) used at d-3-d-2 low dose post-transplant cyclophosphamide PTCy (50mg/kg/d) use at d+3 group B:low dose antithymocyte globulin rATG(2.5mg/kg/d) used at d-2-d-1 low dose post-transplant cyclophosphamide PTCy (50mg/kg/d) use at d+3
15933054|NCT03395847|Biological|Pembrolizumab|Given IV
15933055|NCT03395834|Device|O3|O3 TM and INVOS® monitoring simultaneously in single patient during 3 min of vascular occlusion test
15933056|NCT03395821|Behavioral|Conventional training|traditional training according to residency program
15933057|NCT03395821|Behavioral|Virtual Reality+conventional training|virtual reality training+traditional training using virtual reality
15933058|NCT03395808|Drug|Tramadol|IV; 50 mg given at Hours 0, 2, 4, 8 and every 4 hours thereafter, for a total of up to 43 doses
15933059|NCT03395795|Device|NAVA|"The study has 3 phases:
~Phase 1:
~The patient is connected to the SERVOi® ventilator in classic VNI mode, which is parameterized according to the patient's needs and then maintained for 30min for measurements.
~Phase 2:
~Switch to NAVA mode (1h).
~Definition of NAVA parameters: The positive expiratory pressure will not be modified. The NAVA level (the proportionality factor that converts the EADi (microV) to the pressure level in cmH2O was first adjusted according to the actual assisted pressure in the patient in the normal VNI mode.
~NAVA period: The ventilatory pressure, as well as the EADI is recorded continuously for 30min after a NAVA adaptation period of about 30min.
~Phase 3:
~The patient returns to classic VNI mode with Phase 1 ventilatory settings for a 30 minute recording."
15933060|NCT03395769|Biological|AB-SA01|AB-SA01 is an investigational bacteriophage therapeutic for treatment of Staphylococcus aureus infections
15933061|NCT03395756|Drug|Depot-Medroxyprogestereone Acetate|Administration of 150 mg intramuscular depot medroxyprogesterone acetate
15933062|NCT03395743|Biological|AB-PA01|AB-PA01 is an investigational bacteriophage therapeutic for treatment of Pseudomonas aeruginosa infections
15933063|NCT03395730|Drug|Intraumbilical vein injection oxytocin|intraumbilical vein injection of oxytocin 20 units diluted in 20 ml of 0.9% saline solution immediately after delivery of the baby, clamping and cutting the cord.
15933064|NCT03395730|Procedure|placental cord drainage|placental cor drainage immediately after delivery. This scenario will include placental cord clamping and cutting after delivery of the baby followed by immediately unclamping of the maternal side, allowing the blood to drain freely for a duration of three minutes.
15933106|NCT03395392|Drug|NRX-101|NRX-101, a fixed dose combination of D-cycloserine+lurasidone will be given twice a day by mouth
15933065|NCT03395730|Procedure|Expectant managment of 3rd stage of labour|Placenta will be delivered spontaneously after appearance of clinical signs of placental separation, which include strong uterine contraction, vaginal bleeding, and descending of umbilical cord through the vulva. This scenario will include placental cord clamping and cutting after 2 minutes of delivery of the baby.
15933066|NCT03395717|Device|Exoskeleton-Assisted Gait Training|
15933067|NCT03395704|Drug|LJPC-401|LJPC-401 subcutaneous injection, up to 20 mg weekly for 16 weeks. The minimum weekly dose will be 5 mg and the maximum weekly dose of LJPC-401 will be 20 mg.
15933068|NCT03395704|Drug|Placebo|0.9% Sodium Chloride Injection, USP, or equivalent
15933069|NCT03395691|Procedure|The distal approach|The first two attempts via the distal approach will be performed . If the first two attempts failed, the subsequent attempts of venipuncture were performed using the proximal approach
15933070|NCT03395691|Procedure|The proximal approach|The first two attempts via the proximal approach will be performed . If the first two attempts failed, the subsequent attempts of venipuncture were performed using the distal approach.
15933071|NCT03395678|Device|Microneedling|The exact microneedling settings will be tailored to each patient based on skin type, photodamage, skin thickness based on area of the face. Settings will be adjusted to deliver similar endpoints among all patients. Each participant will receive 5 treatments a month apart.
15933072|NCT03395678|Device|Fractional non-ablative 1,540nm laser|The exact laser settings will be tailored to each patient based on skin type, photodamage, skin thickness based on area of the face. Settings will be adjusted to deliver similar endpoints among all patients. Each participant will receive 5 treatments a month apart.
15933073|NCT03395665|Other|Estradiol level|Estradiol level measured at previous day of embryo transfer procedure
15933074|NCT03395665|Other|Progesterone level|Progesterone level measured at previous day of embryo transfer procedure
15933075|NCT03395665|Other|Endometrial thickness|Endometrial thickness measured at previous day of embryo transfer procedure
15933076|NCT03395639|Drug|Edoxaban|Edoxaban 15 mg or 30 mg tablets for participants 12 to <18 years of age, or 60 mg edoxaban suspension (dosed as mg/kg) for participants under 12 years of age (and optionally, 12 or older), for oral administration
15933077|NCT03395639|Drug|Standard of Care (SOC)|Standard of care could include low molecular weight heparin (LMWH) and/or VKA according to the clinical site's SOC treatment regimen
15933078|NCT03395626|Dietary Supplement|ID-JPL934|probiotics
15933079|NCT03395626|Dietary Supplement|Placebo|corn starch
15933080|NCT03395613|Device|NPWT|Negative pressure wound thearpy on closed surgical wounds
15933081|NCT03395600|Drug|B1S5|Women were then placed supine with left uterine displacement. Epidural labour analgesia was initiated with 5µg sufentanyl along with 5 ml bupivacaine 0.1% as the test dose. After 3 min, 10 ml of 0.1% bupivacaine epidural was injected
15933082|NCT03395600|Drug|B125S5|Women were then placed supine with left uterine displacement. Epidural labour analgesia was initiated with 5µg sufentanyl along with 5 ml bupivacaine 0.125% as the test dose. After 3 min, 10 ml of 0.125% bupivacaine epidural was injected
15933083|NCT03395600|Drug|B1S10|Women were then placed supine with left uterine displacement. Epidural labour analgesia was initiated with 10µg sufentanyl along with 5 ml bupivacaine 0.1% as the test dose. After 3 min, 10 ml of 0.1% bupivacaine epidural was injected
15933084|NCT03395587|Biological|Autologous, tumor lysate-loaded, mature dendritic cells (DC)|Advanced therapy medicinal product (ATMP) produced at the University Hospital Düsseldorf according to Good Manufacturing Practice (GMP) with production permission according §13 AMG (German Drug Law) of the local authorities (Bezirks¬regierung Düsseldorf)
15933085|NCT03395587|Drug|standard therapy|temozolomide, fractionated radiochemotherapy
15933086|NCT03395574|Drug|Terlipressin|drug will be given after 30 minutes of induction of anesthesia
15933087|NCT03395574|Drug|Normal saline|drug will be given after 30 minutes as placebo in control group
15933088|NCT03395561|Dietary Supplement|green coffee|2 capsuls
15933089|NCT03395561|Other|control|2 capsuls
15933090|NCT03395548|Drug|Macrogol|Used drug: Macrogol (osmotic laxative)
15933091|NCT03395535|Procedure|Primary Selective Laser Trabeculoplasty Treatment Pathway|"Primary Selective Laser Trabeculoplasty Treatment (followed by medications as required) Pathway.
~First treatment is SLT, 100 shots of laser over 360 degrees. If this does not reach the target IOP then repeat laser (once only) is given. If IOP not at target additional treatment with all standard medications may be used and ultimately surgery (trabeculectomy ).
~All available medical treatments (eye-drops) are permitted according to a pre-specified intervention protocol described in detail in the publicly available trial protocol. This begins with prostaglandin analogues, then beta-blockers followed by alpha agonists or carbonic anhydrase inhibitors. The full range of available doses, treatments and drugs is beyond this short summary."
15933092|NCT03395535|Drug|Primary Medical Treatment Pathway|"Primary Medical Treatment Pathway (multiple medications, as required). If IOP not at target additional treatment with all standard medications may be used and ultimately surgery (trabeculectomy ).
~All available medical treatments (eye-drops) are permitted according to a pre-specified intervention protocol described in detail in the publicly available trial protocol. This begins with prostaglandin analogues, then beta-blockers followed by alpha agonists or carbonic anhydrase inhibitors. The full range of available doses, treatments and drugs is beyond this short summary."
15933093|NCT03395522|Device|iTind|device implanted for 5-7 days
15933094|NCT03395496|Drug|Biodentine|Biodentine pulpotomy agent
15933095|NCT03395496|Drug|ProRoot (Aggregate)|ProRoot MTA pulpotomy agent
15933096|NCT03395483|Other|Haemodynamic monitoring|see Group description
15933097|NCT03395470|Drug|PXL770|MAD
15933098|NCT03395470|Drug|Placebo|MAD
15933099|NCT03395470|Drug|Rosuvastatin|DDI
15933100|NCT03395457|Drug|Care as usual|Application of usual pharmacological care for chronic migraine
15933101|NCT03395457|Other|Manual Therapy|5 sessions of manual therapy over 12 weeks
15933102|NCT03395444|Device|pulsed shortwave therapy|Pulsed shortwave therapy us the RecoveryRx device. Emits a pulsed signal a the 27.12Mhz wavelength
15933103|NCT03395431|Other|Fingerprick autologuos blood (FAB)|Intervention involves the instillation of whole blood obtained from the prick of a clean finger 4 times a day.
15933104|NCT03395405|Drug|Nitazoxanide|One 500 mg tablet twice daily with food for 56 consecutive doses
15967366|NCT03132103|Radiation|Placebo SSR|
15933108|NCT03395379|Procedure|RFA|Radiofrequency ablation (RFA) is a medical procedure in which part of the electrical conduction system of the tumor is ablated using the heat generated from medium frequency alternating current.
15933109|NCT03395366|Other|Multifaceted Educational / Cognitive Behavioral Intervention|The intervention includes 8 to 12 one-on-one sessions over a 12-week period, run by a licensed social worker (LSW) with experience delivering therapy. Curriculum will introduce education relevant for self-management and consists of prepared slides, handouts & worksheets. The education was designed based on slides developed and published online by the national kidney foundation and the national kidney disease education program. The curriculum was designed to be understandable by all potential subjects, including those with low literacy levels. Sessions will incorporate behavior-based activities designed to deliver education about and improve upon medication adherence, diet, exercise, and coping. These activities, based around CB strategies such as cognitive restructuring and behavior shaping, will include review of self-management logs, goal setting, creation of treatment plan, problem-solving techniques, reinforcing techniques, and coping with ESRD.
15933110|NCT03395353|Drug|Duloxetine Hydrochloride|Administered orally
15933111|NCT03395340|Drug|Ruxolitinib 1.5% cream|Topical formulation of ruxolitinib, a JAK 1/2 inhibitor.
15933112|NCT03395340|Drug|vehicle cream|Matching vehicle cream applied as a thin film
15933113|NCT03395327|Other|quality of life questionnaire|QLQ-C30 and BR23 (Quality of Life Questionnaire and Breast 23) Questionnaire FSFI (Female Sexual Function Index)
15933114|NCT03395314|Drug|Ketamine|1 single dose of IV ketamine
15933115|NCT03395314|Drug|Midazolam|1 single dose of IV midazolam
15933116|NCT03395301|Device|Coil|Fiber platinum coil were inserted into the interstitial part of the tubes of patients in hydrosalpinx through hysteroscopy
15933117|NCT03395288|Drug|D-Mannose|A total of 2 g D-mannose daily
15933118|NCT03395275|Behavioral|Quantitative Sensory Tests|"Three testing modalities will be utilized for this study:
~Hot threshold test: The hot threshold method we will be utilizing has been described in the literature with good reproducibility and reliability. We will be using a similar system and have reproduced the program using a non-invasive device.
~Cold threshold test: the same non-invasive device will be used to test cold detection and pain threshold levels. This method is previously described.
~Pressure threshold: Mechanical testing (pressure pain threshold) will be assessed utilizing an algometer. We have used this method in a previous study and published results."
15933119|NCT03395275|Behavioral|surveys|surveys including anxiety, depression, pain behavior, fatigue, pain interference, physical function, sleep disturbance, self-efficacy, satisfaction roles
15933120|NCT03395262|Dietary Supplement|Active with caffeine|Novel formula with caffeine
15933121|NCT03395262|Dietary Supplement|Active without caffeine|Novel formula without caffeine
15933122|NCT03395262|Dietary Supplement|Placebo|Dextrose placebo
15933123|NCT03395249|Drug|SPR994|"SAD: Double-blind dosing will occur in all SAD Cohorts except for Cohort 12. In each cohort, six subjects will receive one of five different timed release formulations of SPR994 and 2 subjects will receive placebo. Subjects in SAD Cohorts 2, 3, 6, 16 and 17 will receive a single dose following a 10-h fast. Subjects in SAD Cohorts 1, 8-15 will receive one dose of SPR994 or placebo following a 10-h fast on Day 1 and a second dose following consumption of a standardized meal on Day 7. The dose escalation steps may be altered following review of the safety data of each cohort.
~MAD: Double-blind dosing will occur in all MAD Cohorts. Subjects will receive multiple doses of an optimal timed release formulation of SPR994 in MAD Cohort 4 (300 mg) and Cohort 5 (600 mg) or placebo for 14 consecutive days at either BID or TID dosing beginning on Day 1."
15933124|NCT03395249|Drug|Placebo Oral Tablet|Mannitol 200SD SAD: Two subjects in each cohort will receive matching placebo. MAD: Two participants in each cohort will receive matching placebo.
15933125|NCT03395249|Drug|Orapenem®|Tebipenem pivoxil granules
15933127|NCT03395223|Drug|Methylene Blue|Administration of Methylene Blue to treat acquired methaemoglobinaemia
15933128|NCT03395210|Drug|PRN1008|BTK inhibitor
15933131|NCT03395184|Drug|Placebo PF-06651600|12 weeks, followed by PF-06651600, 50 mg QD for 52 weeks
15933132|NCT03395184|Drug|Placebo PF-06700841|12 weeks, followed by PF-06700841, 30 mg QD for 52 weeks.
15933133|NCT03395184|Drug|PF-06651600|200 mg QD for 8 weeks, followed by 50 mg QD up to 56 weeks
15933134|NCT03395184|Drug|PF-06700841|60 mg QD for 12 weeks followed by 30 mg QD for up to 52 weeks
15933135|NCT03395171|Dietary Supplement|Cholecalciferol (Vitamin D3)|Supplementation of subjects who meet the inclusion criteria and test to have below the threshold of vitamin D in their blood.
15933136|NCT03395158|Diagnostic Test|Implementation of new alert criteria|The intervention is when the prior alert criteria are replaced by the present alert criteria
15933137|NCT03395145|Device|Geistlich Bio-Oss® Collagen and Geistlich Mucograft® Seal|Geistlich Bio-Oss® Collagen is intended to be used for filling bone defects and for bone augmentation after tooth extraction
15933138|NCT03395132|Drug|Fucicort® Lipid cream|The active ingredient of Fucicort® Lipid cream are Fusidic acid and betamethasone. The pack size of Fucicort® Lipid cream is 15g.
15933139|NCT03395132|Drug|Fucidin® cream|The active ingredient of Fucidin® cream is Fusidic acid. The pack size of Fucidin® cream is 15g.
15933140|NCT03395132|Drug|Fucicort® Lipid cream vehicle|The active ingredient of Fucicort® Lipid cream vehicle is the identical cream of Fucicort® Lipid cream but without the active ingredient. The pack size of Fucicort® Lipid cream vehicle is 15g.
15933141|NCT03395132|Drug|betamethasone (Lianbang Beisong®) cream|The active ingredient of betamethasone (Lianbang Beisong®) cream is Betamethasone hydrate. The pack size of betamethasone (Lianbang Beisong®) cream is 15g.
15933142|NCT03395119|Drug|Ozone|After the four-week supplementation period, each subject will be blindly exposed on consecutive days to filtered air for 2 hours and to 0.3 ppm ozone for 2 hours, while undergoing intermittent moderate exercise (minute ventilation of 20 L/min/m²).
15933365|NCT03393312|Device|Transcranial direct current stimulation (tDCS)|Electric current
15933143|NCT03395119|Dietary Supplement|Fish Oil|3 (1-gram) soft-gels daily Commercially available, enteric-coated, soft-gels formulated to deliver >60% eicosapentaenoic/docosahexaenoic acids (EPA/DHA)
15933144|NCT03395119|Dietary Supplement|Olive Oil|3 soft-gels daily Commercially available soft-gels containing 1 gram of USDA organic certified, cold pressed, extra virgin, olive oil
15933145|NCT03395106|Behavioral|Parent source|Having a parent feature prominently in a news story
15933146|NCT03395106|Behavioral|Doctor source|Having a doctor feature prominently in a news story
15933147|NCT03395106|Behavioral|Deliberative content|News story content includes process of weighing the risks/benefits of vaccinating, the importance of vaccines for community protection, and concludes with a recommendation to vaccinate.
15933148|NCT03395106|Behavioral|Intuitive content|News story content focuses on the consequences of not vaccinating (including vaccine preventable diseases) and the decisional regret.
15933149|NCT03395093|Drug|Fentanyl|Five minutes before the patients is done the flexible bronchoscopy, fentanyl will be intravenous injected.
15933150|NCT03395093|Drug|Midazolam|Five minutes before the patients is done the flexible bronchoscopy, midazolam will be intravenous injected.
15933151|NCT03395093|Drug|Propofol|Propofol will be intravenous injected as soon as the flexible bronchoscopy begins.
15933152|NCT03395093|Device|Bispectral Index monitoring|Bispectral Index monitoring will be used in the process of the flexible bronchoscopy.
15933153|NCT03395080|Drug|Paclitaxel|Administered by IV infusion
15933154|NCT03395080|Drug|300mg DKN-01|Administered by IV infusion
15933155|NCT03395080|Drug|600mg DKN-01|Administered by IV infusion
15933156|NCT03395067|Behavioral|Intervention group|Lifestyle counseling coupled with psychotherapeutical intervention
15933157|NCT03395054|Other|cervical stabilization exercises|cervical stabilization exercises
15933158|NCT03395054|Other|conventional exercises|conventional exercises
15933159|NCT03395041|Diagnostic Test|cardiac imaging tests|cardiac computed tomography, echocardiography, intravascular ultrasound, optical coherence tomography
15933160|NCT03395028|Drug|Granulocyte Colony-Stimulating Factor|G-CSF is a glycoprotein produced by monocytes, fibroblasts, and endothelial cells. Filgrastim is a human granulocyte colony stimulating factor (G-CSF) produced by recombinant DNA technology with NEUPOGEN® as the Amgen Inc. trademark for filgrastim. G-CSF regulates the production, proliferation and differentiation of neutrophils and hematopoietic stem cell precursors within the bone marrow leading to dose-dependent increase in circulating neutrophils and hematopoietic stem cells in the blood. It is indicated to reduce the incidence of infection in patients with severe neutropenia, for neutrophil recovery in neutropenic patients with bone marrow depletion, to mobilize hematopoietic progenitor stem cell for collection by leukapheresis in hematopoietic stem cell transplantation.
15933161|NCT03395015|Other|VAS scale (from 1 to 10) esthetic assessment of facial 3-D images|The rating process is biphasic: firstly a 3-D model is showed to the raters, who can orientate the vultus, familiarize with the 3-D technology and have a first glance evaluation. Secondly, the judges are asked to rate each of the following patient views: right profile, left profile, frontal, neck hyperextension and hyperflexion views Two weeks after the first assessment, the same judges assessed the same number of pictures, once again in random order.
15933162|NCT03395002|Drug|Tiotropium/Salmeterol/Fluticasone 9/50/500 mcg Inhalation Powder|Tiotropium/Salmeterol/Fluticasone 9/50/500 mcg Inhalation Powder (1 puff) twice daily via Discair® for two days.
15933163|NCT03395002|Drug|Tiotropium 18 mcg Inhalation Powder|Tiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler® for two days.
15933164|NCT03395002|Drug|Salmeterol/Fluticasone 50/500 mcg Inhalation Powder|Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Diskus® for two days
15933165|NCT03394989|Drug|Fluticasone propionate/salmeterol 100/50 µg|Test Arm: Dry powder inhaler
15933166|NCT03394989|Other|Placebo|Placebo
15933167|NCT03394989|Drug|Advair Diskus 100/50 Dry Powder Inhaler, 60 ACTUAT|Comparator Arm: Dry powder inhaler
15933168|NCT03394976|Diagnostic Test|No intervention|No intervention
15933169|NCT03394963|Behavioral|Food-based dietary guidelines for healthier diet|Develop and validate food-based dietary guideline and a healthy eating index
15933170|NCT03394950|Drug|Butyphthalide combined with rtPA|Intravenous treatment with 25mg butyphthalide, followed by intravenous throbolysis with 0.9mg/kg rtPA. Next day, intravenous treatment with 25mg butyphthalide 2 times/day for 14 days, followed by oral butyphthalide capsule (0.2g 3 times/day) to 90 days after thrombolysis. Other treatments were done according to guidelines.
15933171|NCT03394950|Drug|rtPA|Intravenous thrombolysi with 0.9mg/kg rtPA, followed by other treatments according to guidelines
15933172|NCT03394937|Biological|ECI-006|ECI-006 consists of TriMix and 5 tumor associated antigens mRNA. TriMix is a mixture of mRNAs that encodes potent immune stimulating molecules
15933173|NCT03394924|Drug|EDP-305 1 mg|Two tablets daily for 12 weeks
15933174|NCT03394924|Drug|EDP-305 2.5 mg|Two tablets daily for 12 weeks
15933175|NCT03394924|Drug|Placebo|Two tablets daily for 12 weeks
15933176|NCT03394911|Biological|250mg healthy adult male facial skin surface lipid liquid pheromone|Human Pheromone provided p.o. to tox-screen verified opioid drug addict
15933177|NCT03394898|Other|body mass index, eating behaviour|The patients' weights and heights will be measured and the body mass index will be calculated from the measured values.Patients' eating behaviour will be questioned with Three Factor Eating Questionnaire. The 18-item Three-Factor Eating Questionnaire is a scale that measures three domains of eating behavior: cognitive restraint , uncontrolled eating and emotional eating.
15933178|NCT03394885|Drug|Atezolizumab|1200mg IV q3weeks
15933179|NCT03394885|Drug|Carboplatin|5-6mg/ML IV q3 weeks
15933180|NCT03394885|Drug|Paclitaxel|70-80 mg/m2 IV q1 week
15933181|NCT03394885|Drug|Bevacizumab|15 mg/kg IV q3 weeks
15933182|NCT03394872|Procedure|Drainage of the pleural effusion|
15933183|NCT03394846|Behavioral|Prototype Movement Integration Product|A movement integration product prototype based on the findings from Aim 1 will be developed. Teacher will test the prototype Movement Integration Product in their classrooms for four weeks.
15933184|NCT03394833|Other|gelofusine|Preoperative colloid fluid bolus 6ml/kg ideal body weight
15933185|NCT03394820|Drug|Dexamethasone|The intervention is the time when dexamethasone is administered
15933186|NCT03394807|Drug|Levobupivacaine|Levobupivacaine injection to Transversus abdominis plane and rectus sheath
15933187|NCT03394807|Drug|Placebo|Saline injection to Transversus abdominis plane and rectus sheath
15933188|NCT03394794|Device|Pelvic floor rehabilitation|The aim is to compare how each treatment improves symptoms and quality of life and which physiologic mechanisms affects. The basal treatment which other therapies are compared to is Kegel.
15933189|NCT03394781|Drug|DUR-928|oral suspension daily for 28 days
15933190|NCT03394768|Other|No additional intervention|Patients will be treated as per department protocols and no additional intervention will be performed
15933191|NCT03394755|Biological|Thrombosomes|Freeze-dried platelets
15933192|NCT03394742|Behavioral|Peer support|Peer support persons are breast cancer survivors, who were educated to give peer support. They contacted participants by telephone.
15933193|NCT03394729|Drug|Propolis tablet to limit dental biofilm|The tablets will be offered in an exact number of days of use. Collection of total stimulated saliva and dental biofilm will be performed at the beginning of the study (before tablet consumption) and 7 days after the intervention. Saliva samples from each individual will be collected in separate containers as well as the biofilm samples, both at baseline and after 7 days
15933194|NCT03394729|Drug|Xilytol tablet to limit dental biofilm|The tablets will be offered in an exact number of days of use. Collection of total stimulated saliva and dental biofilm will be performed at the beginning of the study (before tablet consumption) and 7 days after the intervention. Saliva samples from each individual will be collected in separate containers as well as the biofilm samples, both at baseline and after 7 days.
15933195|NCT03394716|Radiation|Radiotherapy|standard radiotherapy treatment with 1-3 extra MRIs
15933196|NCT03394690|Dietary Supplement|green coffee|2 capsuls
15933197|NCT03394690|Other|control|2 capsuls
15933198|NCT03394677|Drug|RVT-501 0.5% ointment|Patients will receive RVT-501 0.5% ointment twice daily (BID) for 4 weeks.
15933199|NCT03394677|Drug|Vehicle ointment|Placebo comparator - ointment twice daily (BID) for 4 weeks.
15933200|NCT03394664|Behavioral|Feeding Study|Food provision throughout the study: 1) Run-In Phase (VLC diet, weight loss); 2) Residential Phase (3 different test diets, weight-loss maintenance).
15933201|NCT03394651|Drug|Oral medications to treat lower urinary tract symptoms|Patients in this group will receive oral medication(s) depending on doctors' prescriptions.
15933202|NCT03394651|Procedure|Minimal invasive transurethral prostate procedures|Patients in this group will receive surgical treatment.
15933203|NCT03394638|Other|Access to online eLearning module|Patients enrolled in the Online group have access to an online platform called BePatient. Patients are given the ability to access the platform and do eLearnings; watch videos about the operation and recovery; do quizzes, see dietary advices; see news about obesity and our department; read patients' stories. They are also able to chat with other patients.
15933204|NCT03394638|Other|Access to measurement devices|Patients in the device group have, in addition to patients in the Online group, access to 4 measuring devices, including: weight scale, oximeter, activity bracelet and blood pressure device. Those devices are connectable to their mobile phones where patients can view their own progress.
15933205|NCT03394638|Procedure|Conventional group|All patients undergo the standard of care which included: the bariatric procedure and several outpatient visits including consultation with their surgeon, obesity nurses, dieticians and (if indicated) psychologists.
15933206|NCT03394625|Procedure|Socket shield technique|Socket shield technique is a recent technique which is by sectioning the root and extraction of palatal part and leaving buccal part of the root with its attachment of periodontal ligament and vascularization still intact then placing implant in palatal socket.
15933207|NCT03394625|Procedure|using Xenograft material|placing xenograft material in gap between the implant and the buccal plate of bone
15933208|NCT03394612|Biological|EHSG-KF|Transplantation of autologous dermo-epidermal skin substitute EHSG-KF to the experimental area
15933209|NCT03394612|Biological|STSG|Transplantation of autologous split-thickness skin graft to the control area
15933210|NCT03394599|Device|TheraTrainer + Motiview|TheraTrainer will be used in conjunction with Motiview.
15933211|NCT03394599|Device|TheraTrainer Only|TheraTrainer will be used.
15933212|NCT03394586|Drug|Exposure to golimumab|retrospective chart review to assess patient related outcomes and objective measures of inflammation at baseline, 6-10 weeks, 6 months, 12 months.
15933213|NCT03394573|Other|OCT guided treatment arm|Intravitreal injection of Aflibercept for DME OCT guided
15933214|NCT03394573|Other|VA guided treatment arm|Intravitreal injection of Aflibercept for DME VA guided
15933215|NCT03394560|Device|High frequency repetitive transcranial magnetic stimulation|Gait training with body weight support will be performed through Biodex Rehabilitation treadmill. It will performed for 20 minutes and researchers will assist the patient in placing the foot on the ground, in the extension of the knee and in the alignment of pelvis and trunk. The percentage of body weight support and speed of treadmill will be modified based on the performance of each patient. Repetitive transcranial magnetic stimulation will be applied by an eight-shaped coil positioned on the patient's scalp and performed according to the 10-20 international system (primary motor cortex). In sham rTMS two coils will be used: (i) a coil connected to the stimulator will be positioned behind the patient (away from the scalp) to generate characteristic stimulus sound, and (ii) another coil will be disconnected from the stimulator and positioned on the scalp individual. The active and sham stimulation will last 20 minutes.
15933216|NCT03394560|Device|Sham High frequency repetitive transcranial magnetic stimulation|Gait training with body weight support will be performed through Biodex Rehabilitation treadmill. It will performed for 20 minutes and researchers will assist the patient in placing the foot on the ground, in the extension of the knee and in the alignment of pelvis and trunk. The percentage of body weight support and speed of treadmill will be modified based on the performance of each patient. Repetitive transcranial magnetic stimulation will be applied by an eight-shaped coil positioned on the patient's scalp and performed according to the 10-20 international system (primary motor cortex). In sham rTMS two coils will be used: (i) a coil connected to the stimulator will be positioned behind the patient (away from the scalp) to generate characteristic stimulus sound, and (ii) another coil will be disconnected from the stimulator and positioned on the scalp individual. The active and sham stimulation will last 20 minutes.
15933217|NCT03394547|Device|Allay|pulsed shortwave therapy treatment for painful periods
15933218|NCT03394547|Device|Placebo|A placebo device is given which is identical to the Allay device but emits no pulsed shortwave therapy.
15933219|NCT03394534|Other|CGA group|CGA Plus Individualised Care and Support Plan delivered by Advanced Clinical Practitioner (ACP)
15933220|NCT03394521|Other|Routine clinical practice|This is an observational study
15933221|NCT03394508|Drug|ALK Alutard birch or 5-grasses|Intralymphatic injection with 1000 units. 3 injections with 4-5 weeks interval (0,1 ml) and one additional booster injection with 1000 units before the second pollen season.
15933222|NCT03394508|Drug|ALK diluent 0,3% human albumin|Intralymphatic injection with 0.1 ml. 3 injections with 4-5 weeks interval
15933223|NCT03394495|Other|BCE Combination group|The combination intervention programme consists of a weekly exercise training sessions and 6 sessions of Behavioral Change Enhancement (BCE) programme.
15933224|NCT03394482|Drug|Lu AF35700 5 mg clinical formulation|Lu AF35700 tablets 5 mg oral single dose
15933225|NCT03394482|Drug|Lu AF35700 5 mg commercial formulation|Lu AF35700 tablets 5 mg oral single dose
15933226|NCT03394482|Drug|Lu AF35700 10 mg clinical formulation|Lu AF35700 tablets 10 mg oral single dose
15933227|NCT03394482|Drug|Lu AF35700 10 mg commercial formulation|Lu AF35700 tablets 10 mg oral single dose
15933228|NCT03394482|Drug|Lu AF35700 20 mg clinical formulation|Lu AF35700 tablets 20 mg oral single dose
15933229|NCT03394482|Drug|Lu AF35700 20 mg commercial formulation|Lu AF35700 tablets 20 mg oral single dose
15933230|NCT03394469|Other|collection|Blood, urinary and faecal samples
15933231|NCT03394456|Other|diabetes program|Comprehensive diabetes program (weekly to bimonthly CHW mHealth contact (phone, text) for 12-months and monthly diabetes group visits for 6-months)
15933232|NCT03394456|Other|telehealth training and support for Community Health Workers|weekly 1-hour diabetes training and patient support for CHWs via telehealth i.e., ZOOM technology for the study duration
15933233|NCT03394443|Behavioral|Semi-structured interviews|"Semi-structured interviews of the parents of preterm infants. 3 weeks after their child has left hospital. They will be made either at the University Hospital of Besançon. They will take place in a dedicated hospital ward to ensure the confidentiality of the statements made between the investigator and the parent.
~They will follow a predefined questionnaire. They will be fully recorded on a dictaphone with note taking during the interview by the investigator and will be transcribed in writing anonymously and confidentially on Word.
~The content of the interviews will be analyzed:
~As a first step, it will be a vertical analysis of the thematization of each interview
~Then, in a second step, a transversal analysis between the contents of the different interviews."
15933234|NCT03394430|Drug|Placebos|Patients in Group A receive intranasal normal saline before anesthesia. Anaesthesia was induced with 8% sevoﬂurane initially. Sevoflurane concentration decreased to 2% after intubation. An electroencephalogram was recorded before and during induction up to 10 min after the start of induction.
15933235|NCT03394430|Drug|Midazolam|Patients in Group B receive intranasal 0.25mg/kg midazolam before anesthesia. Anaesthesia was induced with 8% sevoﬂurane initially. Sevoflurane concentration decreased to 2% after intubation. An electroencephalogram was recorded before and during induction up to 10 min after the start of induction.
15933236|NCT03394430|Drug|Dexmedetomidine|Patients in Group C receive intranasal 1μg/kg dexmedetomidine before anesthesia. Anaesthesia was induced with 8% sevoﬂurane initially. Sevoflurane concentration decreased to 2% after intubation. An electroencephalogram was recorded before and during induction up to 10 min after the start of induction.
15933237|NCT03394417|Device|StrataXRT|randomized patient allocated to this group will receive 2 50g tubes of StrataXRT for application during the treatment and 4 weeks further after the treatment ends.
15933238|NCT03394404|Device|ECG-I mapping and PVI|ECG-I mapping and PVI
15933239|NCT03394391|Behavioral|Daily ART-adherence SMS reminder|Interactive and tailored SMS reminders that are acceptable to the participants to remind them to take their medications and to make clinic attendance.
15933240|NCT03394391|Behavioral|Standard Adherence Counselling/Patient experience group chat|"All the participants will receive the standard adherence counselling by trained counsellors at each visit.
~All participants will also be enlisted in a group chat on social media where they will discuss their experiences with the quality of HIV services rendered at their respective clinics. A specialist who will have very minimal involvement will give weekly feedback and counsel on how best to resolve prominent challenges."
15933242|NCT03394352|Other|Activity on Board|During the collection phase, the study team will collect information on glucose values, activity measures and insulin settings. This information will be used to determine the meal and correction boluses during the study admission. Subjects will wear a continuous glucose monitor during the data collection phase and study admission.
15933243|NCT03394352|Other|Usual Diabetes Care|Subjects will perform their usual diabetes care including basal rate, meal and correction boluses during the study admission. Subjects will wear a continuous glucose monitor during the study admission.
15933244|NCT03394326|Behavioral|family-based obesity prevention lifestyle intervention|A family-based obesity prevention lifestyle intervention is based on the combination of behavioral therapy strategies, a physical activity prescription and a dietary prescription. Both the parent and child will be working to achieve the same behavioral targets.
15933245|NCT03394300|Other|iol power calculation|iol power calculation in high myopia
15933246|NCT03394287|Drug|SHR-1210|SHR-1210 200mg (3mg/kg for patient whose weight is below 50kg) will be administered as an intravenous infusion over 30 minutes every two weeks until unacceptable toxic effects or disease progression or other termination criteria appeared.
15933247|NCT03394287|Drug|Apatinib|Apatinib 250mg will be taked daily/intermittent dosing until unacceptable toxic effects or disease progression or other termination criteria appeared.
15933248|NCT03394274|Other|restrictive and liberal transfusion|hemoglobin threshold value was accepted 8g/dl. restrictive blood transfusion group was defined that if perioperative transfusion was started equal or under hemoglobin level 8 g / dL. Liberal blood transfusion group was defined as perioperative transfusion was started over hemoglobin level 8 g / dL .
15933249|NCT03394261|Behavioral|Patient Decision Aid|PtDA-MAT will provide information on MAT treatment options and pros and cons of each treatment option, and will assess patients' preferred options.
15933250|NCT03394248|Device|Vector Mouthguard|The mouthguard will be used by athletes to measure the magnitude and number of impacts throughout one season.
15933251|NCT03394235|Device|Long-pulsed, 1064nm Nd-YAG laser|This long-pulsed Nd-YAG laser is commonly used for laser hair removal and vascular lesions, but in this study it is used to reduce the size of the hair shaft at the occipital area.
15933252|NCT03394222|Drug|preoperative budesonide inhalation|
15933253|NCT03394222|Drug|preoperative normal saline inhalation|
15933254|NCT03394209|Drug|Favipiravir|"In first step: favipiravir tablet is orally administered. This drug will be given twice daily for a 10-day period. For the First day, the dosage is 1600 mg twice daily. Starting from the second day, the dosage is 600 mg twice daily.
~In second step: favipiravir tablet is orally administered. This drug will be given twice daily for a 10-day period. For the First day, the dosage is 1800 mg twice daily. Starting from the second day, the dosage is 800 mg twice daily."
15933255|NCT03394209|Drug|Oseltamivir 75Mg Capsule|oseltamivir will be administered at 75mg twice daily orally for 10 days
15933256|NCT03394196|Diagnostic Test|HIV-2 Genotypic Drug Resistance Testing using DBS|Real time HIV-2 genotypic drug resistance testing using dried blood spots and consensus sequencing.
15933257|NCT03394196|Drug|2nd line ART ( Zidovudine 300mg BID + Lamivudine 150mg BID or Tenofovir DF 300mg QD + Lamividine 300mg QD or Emtricitabine 200mg QD + Lopinavir/Ritonavir 400/100mg BID)|1. No resistance: Continue Current ART: Zidovudine 300mg BID + Lamivudine 150mg BID or Tenofovir DF 300mg QD + Lamividine 300mg QD or Emtricitabine 200mg QD + Lopinavir/Ritonavir 400/100mg BID (AZT/3TC or TDF/3TC or TDF/FTC + LPV/r) + Enhanced Adherence Counseling
15933258|NCT03394196|Drug|2nd line ART (Tenofovir DF 300mg QD + Lamividine 300mg QD or Emtricitabine 200mg QD + Lopinavir/Ritonavir 400/100mg BID + Raltegravir 400mg BID )|2. NRTI resistance only: Tenofovir DF 300mg QD + Lamividine 300mg QD or Emtricitabine 200mg QD + Lopinavir/Ritonavir 400/100mg BID + Raltegravir 400mg BID (TDF/FTC or TDF/3TC + LPV/r + RAL) + Enhanced Adherence Counseling
15933259|NCT03394196|Drug|2nd line ART (Tenofovir DF 300mg QD + Lamividine 300mg QD or Tenofovir DF 300mg QD + Emtricitabine 200mg QD + Darunavir 600mg BID-Ritonavir 100mg BID +Raltegravir 400mg BID)|3. NRTI-PI resistance: Tenofovir DF 300mg QD + Lamividine 300mg QD or Tenofovir DF 300mg QD + Emtricitabine 200mg QD + Darunavir 600mg BID-Ritonavir 100mg BID +Raltegravir 400mg BID (TDF/FTC or TDF/3TC +DRV/r2 + RAL) + Enhanced Adherence Counseling
15933260|NCT03394183|Other|Cardiac Rehabilitation|Cardiac rehabilitation is a 6 month program in which patients enrolled attend weekly classes which consist of individualized exercise and risk factor education lectures. This intervention is consistent with standard care procedures for the Cardiovascular Prevention and Rehabilitation Program at the Toronto Rehabilitation Institute Rumsey Centre.
15933261|NCT03394170|Other|Collection of specimens prior to and during surgery|Collection of specimens prior to and during surgery
15933262|NCT03394157|Other|metabolic surgery|operation to cure type2 diabetes
15933263|NCT03394144|Drug|AZD9150, Durvalumab|After confirmed safety with Cohort 1, Cohort 2 will open. Patients allocated in each cohort will be evaluated for DLT
15933264|NCT03394131|Drug|Hylase|hydro-dissection injection of median nerve inside carpal tunnel using hyalase and 10 cc saline
15933265|NCT03394131|Drug|Insulin|hydro-dissection injection of median nerve inside carpal tunnel using 10 IU insulin and 10 cc saline
15933266|NCT03394131|Other|saline|hydro-dissection injection of median nerve inside carpal tunnel using 10 cc saline
15933267|NCT03394118|Drug|Osimertinib|A cycle of study treatment is defined as 28 days. Each subject will continue the study drug(Osimertinib) until disease progression or manifestation of unacceptable toxicity during the study period. The study drug will be administered orally as one 80 mg tablet once a day. The initial dose of the study drug 80 mg daily can be reduced to 40 mg once daily.
15933268|NCT03394105|Drug|intrapleural docetaxel administration|intrapleural docetaxel administration using medical pleuroscopy in malignant effusion with lung cancer
15933269|NCT03394092|Diagnostic Test|Quantitative measurements the changes of IgG glycosylation|Serum (50 each group) is obtained into ethylenediaminetetraacetic acid（EDTA） tubes from all subjects via antecubital venepuncture.Blood is obtained into ethylenediaminetetraacetic acid（EDTA） tubes from all subjects via antecubital venepuncture to assess the quantitative changes of IgG glycosylation by HPLC-MRM at 0 , 3 and 7 days after admission.
15933270|NCT03394079|Procedure|PCI|Percutaneous Coronary Intervention
15933271|NCT03394066|Device|TMS (MagVenture MagPro 100 with MagOption)|TMS will be applied using the MagVenture MagPro 100 with MagOption (MagVenture Inc, Alpharetta, GA) stimulator with a figure-of-eight TMS coil. An MRI compatible version of the figure-of-eight coil will be used inside the MRI scanner with an appropriate TMS coil holder.
15933272|NCT03394027|Drug|ONC201|625 mg by mouth every 7 days; each cycle = 28 days. Patients will receive ONC201 as long as they derive clinical benefit or toxicity becomes impeditive.
15933273|NCT03394014|Procedure|sciatic nerve block|blocking sciatic nerve either at the subgluteal area or the popliteal region for effective anesthesia and analgesia during below knee amputation
15933274|NCT03394001|Procedure|Wound infiltration|Before skin closure,the subcutaneous tissue and skin all around the wound will be infiltrated by 20 mL of the drug then closure of the skin will be done.
15933275|NCT03394001|Drug|Lidocaine Hydrochloride|20 ml of 1% Lidocaine solution
15933276|NCT03394001|Drug|Ketorolac tromethamine|20 mL of saline with 30 mg ketorolac
15933277|NCT03393988|Drug|Fentanyl infusion|After induction of general anesthesia; Fentanyl infusion (0.5 µg/kg/hr) will be started (which will be afterwards adjusted intraoperatively according to the hemodynamics and Bispectral Index (BIS) reading).
15933278|NCT03393988|Procedure|Ultrasound guided TAP block|After induction of general anesthesia; Patients will receive ultrasound guided subcostal oblique TAP block with 0.25 % bupivacaine 40 ml on each side resulting in a total volume of 80 ml, subcostal TAP block was given twice, at the beginning and at the end of the surgery.
15933279|NCT03393988|Drug|Dexmedetomidine|Dexmedetomidine (200 µg in 2 ml diluted in 48 ml of saline) will be started in a dose of 1 μg/kg over 10 min then maintenance dose as continuous infusion between 0.2 and 0.8 μg/ kg/h through infusion pump (which will be adjusted according to the hemodynamics and BIS reading)
15933280|NCT03393975|Biological|BAX930|Participants in prophylaxis cohort will receive IV infusions of 40 IU/kg BAX 930 ORT during Period 1 and Period 2 and switch to BAX 930 SIN during Period 3 for six months once in a week or twice in a week. In On-demand cohort participants will receive daily IV dose of BAX-930.
15933281|NCT03393975|Biological|Standard of care|Participants will receive Investigator-recommended Standard of care (SoC).
15933282|NCT03393962|Biological|OC-EIEs|2 to 4 infusions, once a week, 0.1~4x10^6 CTLs/kg; injection via IV, abdominal cavity or intrastumoral.
15933283|NCT03393949|Drug|Methylprednisolone 1 mg•kg-1|Patients in Group M received methylprednisolone 1mg•kg-1
15933284|NCT03393949|Drug|isotonic saline 1mg•kg-1|Patients in Group C received isotonic saline 1mg•kg-1
15933287|NCT03393923|Other|Application of the anterior wedge|Application of anterior wedge in tennis
15933288|NCT03393910|Diagnostic Test|Experimental Pelvic Exam|"The pelvic exam will be completed in the following order: external, speculum, bimanual exam in the standard group. In the Experimental group the pelvic exam will be done with external xam, bimanual exam then speculum exam."
15933289|NCT03393897|Other|Trans oesophageal echocardiography|Transoesophageal echocardiography : it's a standard practice for this patient
15933290|NCT03393897|Other|Trendelenburg test|Trendelenburg test : it's a standard practice for this patient
15933291|NCT03393884|Biological|GEN-1|IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer
15933292|NCT03393884|Drug|Carboplatin|AUC 6 IV over 1 hour on Day 1 of each cycle
15933293|NCT03393884|Drug|Paclitaxel|175 mg/m2 IV over 3 hours on Day 1 of each cycle
15933294|NCT03393871|Diagnostic Test|absolute blood flow measurement|Absolute maximum flow will be measured, using the RayFlow® multifunctional monorail infusion catheter. (This measurement takes a few minutes per artery, does not require any additional drug, but only 50-100 ml of saline per artery, and is not associated with any additional risk for the patient compared to the regular invasive procedure.
15933295|NCT03393858|Drug|Anti-PD-1 antibody|Patients will receive pembrolizumab 100mg every three weeks until disease progression, unacceptable toxicity or patient refusal.
15933296|NCT03393858|Biological|DC-CIK Immunotherapy|Mononuclear cells were collected from 50ml peripheral blood , and cultured DC-CIK cells for 15-20 days. Cells were infused back to the patients in 3 times via intravenous infusion .Patients will received at least 2 cycles of DC-CIK Immunotherapy along with 4 dosage of anti-PD-1 antibody treatment. If the evaluation of the treatment is partial response or stable disease, additional cycles were eligible.
15933297|NCT03393858|Device|Thermotron RF-8EX|Hyperthermia for 40 minutes, with maximum temperature setted on 42℃ ± 0.5℃ as upper limit, twice a week since the 1st week of pembrolizumab for a total of 10 times.
15933300|NCT03393819|Drug|DuraPrep|DuraPrep surgical solution
15933301|NCT03393819|Drug|ChloraPrep|ChloraPrep surgical solution
15933302|NCT03393806|Drug|GSK3772847|GSK3772847 will be available as 100 mg/vial, white to yellow, uniform lyophilized cake in a 5 milliliter (mL) clear glass vial with closure sealed by red metal and yellow overseal.
15933303|NCT03393806|Drug|Placebo|Commercially sourced sterile normal saline will be provided as Placebo
15933304|NCT03393780|Drug|Follitropin Delta|The Intervention (solution for injection) is delivered with an injection pen. The REKOVELLE® dose will be based on recent determination (within the last 12 months) of AMH (anti- müllerian hormone) measured by the following diagnostic test from ROCHE: ELECSYS AMH Plus immunoassay.
15933305|NCT03393767|Drug|Ranibizumab|Intravitreal injection
15933306|NCT03393754|Biological|Hepatitis B Vaccination|Prophylactic Hepatitis B Vaccination
15933307|NCT03393741|Drug|Taxane|Taxane is a chemotherapeutic agent and a standard drug for treatment in breast cancer targeting microtubules. This drug is typically infused as a single agent for breast cancer therapy.
15933308|NCT03393741|Drug|Vinorelbine|Vinorelbine is a chemotherapeutic agent and a standard drug for treatment in breast cancer targeting microtubules. This drug is typically infused as a single agent for breast cancer therapy.
15933309|NCT03393741|Drug|Ixabepilone|Ixabepilone is a chemotherapeutic agent and a standard drug for treatment in breast cancer targeting microtubules. This drug is typically infused as a single agent for breast cancer therapy.
15933310|NCT03393741|Drug|Eribulin|Eribulin is a chemotherapeutic agent and a standard drug for treatment in breast cancer targeting microtubules. This drug is typically infused as a single agent for breast cancer therapy.
15933311|NCT03393741|Drug|Chemotherapy|Chemotherapy is used to treat various stages of breast cancer.
15933312|NCT03393728|Drug|Propanolol|72-hour propanolol before specific treatment of hyperthyroidism
15933313|NCT03393715|Drug|Perindopril Oral Tablet|Perindopril oral tablet morning versus evening
15933314|NCT03393702|Drug|Gabapentin|"Patients in this arm of the study receive identical capsules, containing 15 mg/kg of oral gabapentin.
~Patients after surgery receive identical capsules, containing 7,5 mg/kg of oral gabapentin 2 times per day."
15933315|NCT03393702|Drug|Placebo|"Patients in this arm of the study receive identical placebo capsules 1 hour before surgery.
~Patients after surgery receive identical placebo capsules 2 times per day."
15933316|NCT03393689|Drug|One injection of 68Ga-NODAGA-E[c(RGDyK)]2|One injection of 68Ga-NODAGA-E[c(RGDyK)]2
15933317|NCT03393663|Other|CKD-related outcomes|the study is observational
15933318|NCT03393650|Other|Exercise + Placebo group|1/2 of the subject will follow a mixed power training: 4 power exercises + 6 functional exercises combined to a placebo
15933319|NCT03393650|Other|Exercise + Protein group|1/2 of the subject will receive 30 g/ d of protein (leucine+ vitD; divided in three equal doses: morning, afternoon and evening) + will follow a mixed power training: 4 power exercises + 6 functional exercises.
15933364|NCT03393325|Other|Observation of treatment with Tadalafil-Delivra|Tadalafil 2% in a Delivra base (Transdermal Application)
15933320|NCT03393637|Behavioral|Mentors Offering Maternal Support (M-O-M-S)|10, 1 hour, structured classes meeting every-other-week in person beginning in the first trimester of pregnancy and unlimited access to mentor support.
15933321|NCT03393611|Drug|CPX-351|Salvage Chemotherapy: CPX-351 at 120 u/m2 on Days -21, -19, and -17
15933322|NCT03393611|Drug|Fludarabine|Fludarabine 150 mg/m2 (30 mg/m2/day x 5 days, Day -7 to Day -3)
15933323|NCT03393611|Drug|Melphalan|Melphalan 140 mg/m2 (Day -2)
15933324|NCT03393611|Drug|Rabbit Anti-Human T-Lymphocyte Globulin|Rabbit ATG (rATG)-thymoglobulin 4.5 mg/kg (1.5 mg/kg/day x 3 days)
15933325|NCT03393611|Biological|Haplo-Cord Stem Cell Transplantation|Allogeneic stem cell transplantation using a haploidentical donor and umbilical cord blood unit.
15933326|NCT03393598|Device|pre-expansion using Kiwi® VAC-6000M.|The pre-expansion will be performed with Kiwi® VAC-6000M with the PalmPumpTM.
15933327|NCT03393598|Device|pre-heating using Hilotherm Calido®.|The pre-heating will be performed with Hilotherm Calido®.
15933328|NCT03393598|Device|pre-expansion-heating|Both preconditioning methods - Kiwi® VAC-6000M and additionally Hilotherm Calido® - will be applied.
15933329|NCT03393585|Other|touchless vital signs monitoring|We measure Respiratory Rates in the Triage of Patients entering an Emergency Department by three different methods.
15933330|NCT03393572|Drug|Bupivacaine 0.25%|Patients will receive 30 mL of intraperitoneal bupivacaine 0.25%
15933331|NCT03393572|Drug|Magnesium sulphate.|Patients will receive intraperitoneal 30 mg/kg of magnesium sulphate.
15933332|NCT03393572|Drug|nalbuphine|Patients will receive intraperitoneal 5 mg nalbuphine
15933333|NCT03393559|Procedure|leg elevation|Patients' leg will be raised by a pillow under both legs and the hip and knee joints will be flexed 45 degrees to position both knees at the heart level.
15933334|NCT03393546|Behavioral|Auricular Point Acupressure|It includes 4 weekly auricular point acupressure treatments.
15933335|NCT03393533|Procedure|Group I|Extraction third molar without the application of therapeutic bandaging in the face and with evaluation of edema, pain and trismus
15933336|NCT03393533|Procedure|Group II|Extraction third molar with the application of therapeutic bandaging in the face and with evaluation of edema, pain and trismus
15933337|NCT03393520|Drug|Placebo|oral capsules
15933338|NCT03393520|Drug|AVP-786|oral capsules
15933339|NCT03393507|Drug|Apatinib|500mg,po, adjusted to 250mg if cannot tolerate, 3 weeks a cycle for a total of 6 cycles
15933340|NCT03393507|Drug|Taxus + platinum|Taxanes are paclitaxel or docetaxel, and platinum is carboplatin or cisplatin. Docetaxel injection dose size of 60-75mg / m2, infusion time of 1 hour; paclitaxel injection dose size 135-175mg / m2, infusion time> 3 hours; injection of carboplatin dose according to the standard formula Calculated, AUC = 4-5, continued intravenous infusion the next day; cisplatin injection dose size of 75-100mg / m2.
15933341|NCT03393494|Drug|Adapalene and Benzoyl Peroxide Topical Gel|Test product
15933342|NCT03393494|Drug|Epiduo Topical Product|RLD product
15933343|NCT03393494|Drug|Placebo|Placebo gel
15933344|NCT03393481|Drug|MAA868|MAA868 dose 1 and dose 2, single administration, subcutaneous,
15933345|NCT03393481|Drug|Enoxaparin|Enoxaparin 40 mg, o.d X 10 days
15933347|NCT03393455|Other|not accurate|not accurate
15933348|NCT03393442|Diagnostic Test|Brain MRI scan|Diagnostic brain MRI scan with the purpose to detect signal changes due to brain deposits of Gd.
15933349|NCT03393429|Other|DAVID assisted training|DAVID device assisted training under supervision
15933350|NCT03393429|Other|training recommendation|"training recommendation to stay active"
15933351|NCT03393416|Biological|MASCT-I|The final products of MASCT-I(Multiple-antigen specific cell therapy) technology are dendritic cells (DC) and effector T cells.Treatment with MASCT-I alone, conducted until disease progression, intolerance or end of study.
15933352|NCT03393416|Drug|PD1 antibody|"Drug: PD1 antibody
~1mg/kg or 3mg/kg. Administration is conducted in Day1 and Day15. Conducted until disease progression, intolerance or end of study."
15933353|NCT03393403|Drug|Dexmedetomidine|0.5mcg/kg intravenous(IV)continuous infusion for 30 minutes, or 0.5mcg/kg adding to local anesthetic for subcostal TAP block
15933354|NCT03393403|Drug|0.9% Sodium-chloride|0.125ml/kg intravenously infusion in Dexmedetomidine_adj group and control group
15933355|NCT03393390|Diagnostic Test|Clinical Assessment Visit|Subjects will meet with a clinician who will determine if they meet diagnostic criteria for an externalizing disorder.
15933356|NCT03393390|Other|fMRI scan|Subjects will undergo an fMRI scan where images will be taken for observational purposes only, not as a means of diagnosis.
15933357|NCT03393377|Drug|fluvastatin 10 mg and valsartan 20 mg|
15933358|NCT03393377|Drug|placebo|
15933359|NCT03393364|Drug|Oxycodone|Patients receive oxycodone for pain control after outpatient urologic surgery.
15933360|NCT03393364|Drug|Ketorolac|Patients receive ketorolac for pain control after outpatient urologic surgery
15933361|NCT03393351|Other|Shared decision-making program|"The intervention is shared decision-making. The implementation strategy to foster shared decision-making in routine cancer care is a multicomponent implementation program. The implementation program consists of the following components:
~shared decision-making trainings for health care professionals,
~individual coaching for physicians,
~patient activation strategy,
~provision of patient information material and decision aids,
~revision of the clinics quality management documents, and
~critical reflection of current organization of multidisciplinary team meetings.
~Implementation: after baseline assessment (t0) for clinic 1, after assessment at t1 for clinic 2, after assessment at t2 for clinic 3."
15933362|NCT03393351|Other|Usual Care|No specific study related intervention. Treatment decisions are made according to current routine practice at the comprehensive cancer center in Germany.
15933363|NCT03393338|Behavioral|DM I-TEAM|DM I-TEAM is a home-based behavioral intervention that involve 9 treatment visits with a community health worker (CHW) over 12 months. During the treatment visits, the CHW provides culturally-relevant diabetes education, and facilitates telehealth visits with a diabetes nurse educator and participants' primary care physicians (PCPs). In addition, a clinical pharmacist reviews participants' medication regimens to identify potentially inappropriate medications (PIMS), and to simply regimens when indicated to facilitate medication adherence.
15968357|NCT03124303|Procedure|Magnetic Resonance Imaging|MRI scan of brain
15933366|NCT03393299|Procedure|STOPP/START criteria|software which helps to do the drug reconciliation
15933367|NCT03393273|Drug|Elotuzumab|"Induction 4 cycles of 28 days Elotuzumab IV, 10 mg/Kg, D1, 8, 15, 22 Dexamethasone PO, 40 mg/d, D1, 8, 15 Velcade® IV, 1,3 mg/m2/d, D1, 4, 8, 11 Thalidomide PO, 100 mg/d, D1 to 21
~melphalan 140-200 mg/m2 one day followed by autologous hematopoietic stem cell transplantation
~Consolidation 2 cycles of 28 days (2 to 3 months after autograft) Elotuzumab IV, 10 mg/Kg, D1, 8, 15 and 22 Dexamethasone PO, 40 mg/d, D1, 8 and 15 Velcade® IV, 1,3 mg/m2/d, D1, 4, 8, and 11 Thalidomide® PO, 100 mg/d, D1 to 21"
15933368|NCT03393247|Drug|infliximab and azathioprine combination at week 0|All enrolled CD patients will schedule on IF X (week 0, 2, 6 and then every 8 weeks at 5mg/kg).Experimental group will receive azathioprine at week 0.
15933369|NCT03393247|Drug|infliximab and azathioprine combination at week 14|All enrolled CD patients will schedule on IF X (week 0, 2, 6 and then every 8 weeks at 5mg/kg).Control group will receive azathioprine at week 14.
15933370|NCT03393234|Radiation|Interoperative radiation by INTRABEAM using low energy X-ray|Intrabeam is a mobile Platform for Intraoperative Radiotherapy (IORT) produced by the ZEISS company in Germany.Interoperative radiation by INTRABEAM using low energy X-ray.The Intrabeam PRS appears to be a safe technique for delivering IORT in rectal cancer patients.
15933371|NCT03393221|Behavioral|ER|Emotion regulation content
15933372|NCT03393221|Behavioral|SBWC|
15933373|NCT03393208|Drug|Test GIR|Participants received 500 milligrams (mg) test GIR in fasting or fed state on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2).
15933374|NCT03393208|Drug|Reference GIR|Participants received 500 mg reference GIR in fasting or fed state on either Day 1 (Treatment Period 1) or Day 8 (Treatment Period 2).
15933375|NCT03393195|Behavioral|Time-restricted Eating plan|Research team will prescribe an eating plan for the participant to follow for the 12 week study. The eating plan will consist of eating during a specified 8 hour window and fasting for the remaining 16 hours of the day.
15933376|NCT03393195|Behavioral|Consistent Meal timing plan|Research team will prescribe an eating plan for the participant to follow for the 12 week study.The eating plan will consist of eating three structured meals each day during three specified meal windows.
15933377|NCT03393182|Procedure|TLDG arm|After lymphadenectomy, gastrectomy and reconstruction procedure are performed intracorporeally without mini-laparotomy(TLDG)
15933378|NCT03393182|Procedure|LADG arm|After lymphadenectomy, gastrectomy and reconstruction procedure are performed extracorporeally through mini-laparotomy(LADG)
15933379|NCT03393156|Behavioral|Internet-based metacognitive therapy|Internet-based metacognitive therapy on a safe internet platform. Treatment is divided into ten modules, each containing homework assignments . The participants will be assigned a therapist that they can contact through a message system in the platform and expect answer within 24 hour
15933380|NCT03393130|Diagnostic Test|APOE genotyping|APOE genotyping and broad cognitive assessment expressed as a median T-score of the following tests (with cognitive domains assessed in brackets) Trail Making Part A (processing speed), Trail Making Part B (executive function), One Back test (working memory), List Learning Task (Immediate recall, visual learning, delayed recall and recognition discrimination).
15933381|NCT03393117|Drug|Liposomal Bupivacaine|20mL vial of Liposomal Bupivacaine (266 mg). The infiltration technique for Liposomal Bupivacaine will be 80mL injected into either hemi-abdomen as a transversus abdominous plane (TAP) block via ultrasound guidance. The other 80mL will be utilized in the operative breast for the field blocks (20mL), pectoralis 1 (20mL), pectoralis 2 (20mL) and serratus anterior (20mL) blocks.
15933382|NCT03393117|Drug|Bupivacaine|20mL vial of 0.25% Bupivacaine. The field blocks (20mL), pectoralis 1 (20mL), pectoralis 2 (20mL) and serratus anterior (20mL) blocks will be performed with 0.25% Bupivacaine.
15933383|NCT03393117|Drug|Patient-Controlled Analgesia Pump|The patient-controlled anesthesia will be filled with morphine or hydromorphone. Pumps will be programmed be on demand only with no basal rate.
15933384|NCT03393117|Drug|Oral Narcotic|Oral narcotics will be offered when the patient's diet is advanced as tolerated, typically post-operative day 1.
15933385|NCT03393104|Behavioral|Motor Control Exercise|Activation of specific muscles of the lumbopelvic region responsible for providing stability or control of posture and movement.
15933386|NCT03393104|Behavioral|Patient Education|Education aiming to change unhelpful beliefs about LBP, decrease fear avoidance behavior and catastrophic thought, promote positive attitude, self-management, and active coping strategies.
15933387|NCT03393078|Device|transcranial magnetic stimulation with real coil|TMS with real coil is a noninvasive technique to activate and modify the activity of the neurons
15933388|NCT03393078|Device|transcranial magnetic stimulation with sham coil|TMS with sham coil is a placebo
15933389|NCT03393065|Other|Fluid management guided by BLS|We propose a randomized study where in the interventional arm the fluid management (volume replacement, diuretics, use of vasopressors) will be guided using the BLS as a sign of pulmonary congestion.
15933390|NCT03393052|Procedure|Coronary Angiography|Comparison of left radial versus femoral access during coronary angiography of patients who have undergone coronary artery bypass grafting surgery
15933391|NCT03393039|Behavioral|Negative Affect Task|fMRI stress task
15933392|NCT03393026|Drug|Lurasidone|Lurasidone 40-160 mg/day for 6 weeks
15933393|NCT03393013|Drug|KZR-616|Subcutaneous Injection of KZR-616
15933394|NCT03393000|Drug|Trans Sodium Crocetinate plus SOC|Trans Sodium Crocetinate (TSC) plus the Standard of Care (SOC): SOC composed of radiation and temozolomide for 6 weeks followed by 4 weeks of rest followed by six (6) 28-day cycles of temozolomide
15933395|NCT03393000|Other|Standard of Care (SOC)|Standard of Care (SOC): SOC composed of radiation and temozolomide for 6 weeks followed by 4 weeks of rest followed by six (6) 28-day cycles of temozolomide
15933396|NCT03392987|Genetic|OTL-200|OTL-200 is an autologous CD34+ enriched cell fraction that contains CD34+ cells transduced with lentiviral vector that encodes for the human ARSA cDNA sequence
15933397|NCT03392974|Biological|Valoctocogene Roxaparvovec|Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Hemophilia A
15933398|NCT03392961|Drug|IN-105 (Insulin Tregopil)|15 mg strength tablets for oral use used at a dose of 30 mg
15933399|NCT03392961|Other|Placebo comparator|Placebo tablet for oral use
15933400|NCT03392935|Device|1540 nanometer Erbium glass laser|Subjects will receive laser treatment by dermatologist at week 0 and week 4.
15968431|NCT03123666|Other|Placebo|Placebo identical to GMCSF will be given
15933401|NCT03392922|Device|Uniblocker|The BBs have more advantages than DLT: easier insertion especially in patients with difficult airway18 and no need to exchange the tube when mechanical ventilation is required after surgery.
15933402|NCT03392922|Device|Left-sided Double-lumen Tube|the double-lumen tube (DLT) is the most commonly used device for OLV
15933403|NCT03392909|Drug|Gentamicin|Short-term intravenous gentamicin therapy should have the advantage of treating all of the patient's multiple skin wounds simultaneously. Six patients (three adults and 3 children) will receive intravenous gentamicin (7.5 mgs/kg) daily for 14 days and then stopped. Three adult patients will receive intravenous gentamicin (7.5mg/kg) biweekly for three months and then stopped.
15933404|NCT03392896|Drug|DCR-PHXC|DCR-PHXC is a novel, potent, and long-acting small interference ribonucleic acid (siRNA) molecule conjugated to N-acteylgalactosamine (GalNAc) that is designed to decrease liver oxalate production. DCR-PHXC is delivered via subcutaneous (SC) injection.
15933405|NCT03392896|Drug|Placebo|Single SC administration of placebo, which will be a sterile, preservative-free normal saline 0.9% solution for SC injection, which is of similar osmolality to the DCR-PHXC formulation.
15933406|NCT03392883|Behavioral|Laddr|Laddr is a mobile behavioral health technology that offers science-based self-regulation monitoring and health behavior change tools via an integrated platform to a wide array of populations. Specifically, the core functionality of Laddr (e.g., problem-solving therapy) will be structured to focus on an end user's management of depression and its impact on their functioning and quality of life. The program will secondarily focus on problematic alcohol use and its relationship to depression management.
15933407|NCT03392870|Other|Integrative interventional programme|The active condition includes specialized, multidisciplinary and intensive individual (weekly to monthly) or group interventions (weekly). Only high-functioning subjects will be considered for group interventions.
15933408|NCT03392870|Other|As usual|The control group will follow treatment as usual, consisting in conventional general psychiatrist/psychologist clinical follow-up. The frequency varies between 3-6 months or 15-21 days if worsening of symptoms or comorbid conditions.
15933409|NCT03392857|Other|Assessment by caregivers of the quality of the end of life in intensive care units|Quality of the end of life in intensive care units perception will be explore from the side of the caregivers, trough the CAESAR scale.
15933410|NCT03392844|Other|Beds for Kids program|"The Beds for Kids program, which is part of the non-profit organization One House at a Time, gives every child in the program a new twin-size bed mattress, metal bed frame, and a bedtime bag, which contains a sheet set, blanket, pillow, several books, stuffed animal, and toothbrush. Children also receive educational messages about healthy sleep habits via a magnet and color-your-own bookmark. All of the items are sorted, packaged, and delivered directly to program recipients in their homes."
15933411|NCT03392831|Other|Peripherally inserted central catheter (PICC)|The peripherally inserted central catheter with different sizes (French scale). Trained vascular access nurses will perform the insertion of the PICC, guided by ultrasound at bedside using the Seldinger technique. A suitable sterile field will be established. In the case of children the procedure may be performed at the Ambulatory Surgical Center
15933412|NCT03392831|Other|Central venous catheter|The central venous catheter with different sizes (French scale). Trained doctors will perform the insertion of the CVC, guided by ultrasound at bedside using the Seldinger technique. A suitable sterile field will be established.The decision of the caliber depends on the clinical evaluation and need for multiple infusional therapy.
15933413|NCT03392818|Other|The measured distance|To measure the distance between the upper edge of the thyroid cartilage to the upper edge of the sternum add the distance from the upper edge of the sternum to the carina calculated according to the chest CT scans as a guide to the placement of Uniblocker without the aid of Fiberoptic bronchoscope.
15933414|NCT03392818|Other|formula|Calculate the depth of intubation according to the formula of 0.1977* patient's height - 4.2423
15933415|NCT03392818|Device|Fiberoptic bronchoscope|The intubation of Uniblocker under the guidance of Fiberoptic bronchoscope
15933416|NCT03392805|Behavioral|physical activity|beginning of regular physical activity under the supervision of a coach
15933417|NCT03392792|Drug|tissue plasminogen activator|role of tissue plasminogen activator in patient with acute ischemic stroke having selective criteria for rTPA
15933418|NCT03392792|Procedure|thrombectomy|role of thrombectomy in patient with acute ischemic stroke
15933419|NCT03392779|Drug|ZSP1601 25 mg|ZSP1601 tablet administered orally once daily under fasted condition
15933420|NCT03392779|Drug|Placebo 25mg|Participants will receive placebo matching to ZSP1601 orally once daily under fasted condition
15933421|NCT03392779|Drug|ZSP1601 50 mg|ZSP1601 tablet administered orally once daily under fasted condition
15933422|NCT03392779|Drug|Placebo 50 mg|Participants will receive placebo matching to ZSP1601 orally once daily under fasted condition
15933423|NCT03392779|Drug|ZSP1601 100 mg|ZSP1601 tablets administered orally once daily in the fasting state
15933424|NCT03392779|Drug|Placebo 100 mg|Participants will receive placebo matching to ZSP1601 orally once daily in the fasting state
15933425|NCT03392779|Drug|ZSP1601 175 mg|ZSP1601 tablets administerekd orally once daily under fasted condition
15933426|NCT03392779|Drug|Placebo 175 mg|Participants will receive placebo matching to ZSP1601 orally once daily under fasted condition
15933427|NCT03392779|Drug|ZSP1601 275 mg|ZSP1601 tablets administered orally once daily in the fasting state
15933428|NCT03392779|Drug|Placebo 275 mg|Participants will receive placebo matching to ZSP1601 orally once daily in the fasting state
15933429|NCT03392779|Drug|ZSP1601 350 mg|ZSP1601 tablets administered orally once daily under fasted condition
15933430|NCT03392779|Drug|Placebo 350mg|Participants will receive placebo matching to ZSP1601 orally once daily under fasted condition
15933431|NCT03392779|Drug|ZSP1601 100 mg|ZSP1601 tablets administered orally once daily under fasted or fed condition
15933432|NCT03392779|Drug|Placebo 100mg|Participants will receive placebo matching to ZSP1601 orally once daily under fasted or fed condition
15933433|NCT03392779|Drug|ZSP1601 50 mg|ZSP1601 tablets administered orally once daily under fasted or fed condition due to the results of Cohort FE for 14 Days(a total of 14 doses).
15933434|NCT03392779|Drug|Placebo 50 mg|Participants will receive placebo matching to ZSP1601 orally once daily under fasted or fed condition due to the results of Cohort FE for 14 Days(a total of 14 doses).
15968752|NCT03121300|Other|Biological Sample Collection|Blood Draw
15933435|NCT03392779|Drug|ZSP1601 100 mg|ZSP1601 tablets administered orally once daily under fasted or fed condition due to the results of Cohort FE for 14 Days(a total of 14 doses).
15933436|NCT03392779|Drug|Placebo 100 mg|Participants will receive placebo matching to ZSP1601 orally once daily under fasted or fed condition due to the results of Cohort FE for 14 Days(a total of 14 doses).
15933437|NCT03392766|Device|single lumen tube and bronchial blocker|neck collar apply. fibreoptic intubation with single lumen tube and bronchial blocker.
15933438|NCT03392766|Device|double lumen tube|neck collar apply. fibreoptic intubation with double lumen tube.
15933439|NCT03392753|Procedure|Mechanochemical ablation|Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein)
15933440|NCT03392753|Procedure|Cyanoacrylate adhesive|Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM)
15933441|NCT03392740|Drug|Lisinopril|Patients will be given lisinopril once a day prior to starting an anthracycline chemotherapy regimen and titrated up in a stepwise fashion, as allowed by patients blood pressure, to a target dose of 20mg daily.
15933442|NCT03392740|Drug|Placebo Oral Tablet|Patients will be given a look-alike placebo medication once a day prior to starting an anthracycline chemotherapy regimen. They will be given a new placebo medication in a step-wise fashion over period of 1 to 3 weeks.
15933443|NCT03392727|Device|Study Box|Baby box (bassinet) with infant items
15933444|NCT03392727|Device|Community Box|Baby box (bassinet)
15933445|NCT03392727|Behavioral|Education Session|Face to face education and baby box orientation session
15933446|NCT03392727|Behavioral|Online Education|Online baby box education
15933447|NCT03392714|Drug|R-B(O)AD|rituximab 375 mg/m2 on day 1; vincristine 1.4 mg/m2 on day 1, omitted in patients ≥70 years of age due to risk of neurotoxicity; bendamustine 75 mg/m2 over 1 h on days 2 and 3; cytarabine 1000 mg/m2 over 3 h on days 2-4; dexamethasone 20 mg on days 1-4, administered intravenously
15933448|NCT03392701|Biological|LPS infusion|infusion of LPS 2 ng/kg over 5 minutes
15933449|NCT03392688|Other|kujala patellofemoral pain scale|Kujala patellofemoral pain scale was used to evaluate knee functions of the PFP subjects.
15933450|NCT03392688|Diagnostic Test|Surface EMG|The surface EMG electrodes (silver/silver chloride, pre-gelled, Ambu Blue Sensor, Denmark) (Konrad P.) with an interelectrode distance of 20 mm between centers were used to record an EMG signal during walking. Portable 8 channel (TELEEMG, BTS, Milan, Italy) with built in x10 amplifications, 10-450 Hz bandpass and sampling rate of 1000 Hz were used for recording. The location and orientation of the electrodes for each MH (ST) and LH (BF) were identified according to SENIAM (Surface ElectromyoGraphy for the Non-Invasive Assessment of Muscles) criteria.
15933451|NCT03392688|Other|Q angle measurement|Q angle measurement was applied to both patellofemoral pain and control group subjects in standing position.
15933452|NCT03392675|Behavioral|Self-monitoring of BF and intervention|"Self-Monitoring: At discharge, mothers will complete daily diaries for self-monitoring to stimulate cognitive reframing on the occurrence, duration, and characteristics of nipple and breast pain, infants' latch and sucking pattern, positioning, length of each BF session, and the MAIBB.
~Self-Regulation: To support self-regulation skills, mothers will be provided with several 5-minute video modules on pain and BF pain SM with additional resources links. After discharge mother will receive text message from a nurse 2X/week for BF support. Mothers may text the nurse for emergent BF support."
15933453|NCT03392662|Device|Hemopatch|Patients received product at the discretion of their surgeon.
15933454|NCT03392649|Device|Parasym|Tragus stimulation will be done using the Parasym device.
15933455|NCT03392636|Procedure|Herniotomy|In Mitchell Banks Herniotomy, one of investigators will do herniotomy without opening inguinal canal and in Ferguson Gross Herniotomy , one of investigators will do herniotmy by opening inguinal canal.
15933456|NCT03392623|Drug|Retinoic acid|topical administration in melasma lesions
15933457|NCT03392623|Device|colorimetry measurement|Measurement of erythema and luminosity through a colorimeter
15933458|NCT03392623|Drug|sunscreen|topical administration in melasma lesions
15933459|NCT03392623|Drug|Niacinamide|topical administration in melasma lesions
15933460|NCT03392597|Behavioral|Brothers as Allies|Strengths-based group approach to promote boys' and young men's safe and healthy passage through the pre-teen and adolescent years.
15933461|NCT03392597|Behavioral|Programming-as-Usual|Usual afterschool programming.
15933462|NCT03392571|Drug|NGC-Triple regimen|gemcitabine 800 mg/m2; Abraxane (nab-paclitaxel 100 mg/m2; cisplatin 25 mg/m2
15933463|NCT03392558|Other|Burt's Bees Skin Care Regimen|Burt's Bees Facial Cleanser (twice daily), Burt's Bees Sensitive Daily Moisturizing Cream (morning), Burt's Bees Sensitive Night Cream (at bedtime)
15933464|NCT03392558|Other|Control Regimen|Cetaphil Gentle Skin Cleanser (twice daily), Cetaphil Moisturizing Lotion (twice daily)
15933465|NCT03392545|Combination Product|Combined immune adjuvants and radiation|24 hours before the radiation, patients will be administrated poly I:C or CAR-T or TCR-T intratumorally and receive granulocyte macrophage colony stimulating factor 5 days after the radiation.
15933466|NCT03392532|Device|Lotrafilcon B toric contact lenses with HYDRAGLYDE|Silicone hydrogel soft contact lenses for astigmatism
15933467|NCT03392532|Device|Lotrafilcon B toric contact lenses|Silicone hydrogel soft contact lenses for astigmatism
15933468|NCT03392519|Other|Chronic stroke|MRI data acquisition and behavioral test
15933469|NCT03392506|Device|EBUS-TBNA-RTE|Every patient will do CT、 PETCT and EBUS-TBNA-RTE.These three kind of examination will have their own result.The three methods of inspection will be compared by diagnostic rate
15933470|NCT03392493|Behavioral|Robot-assisted hand rehabilitation|Robot-assisted hand rehabilitation: 20 minute of worm-up exercise and 40 minute of robot-assisted hand exercise. Robot-assisted hand exercises include passive range of motion of hand, bilateral hands task and robot-assisted task.
15933471|NCT03392493|Behavioral|Standard treatment|Standard treatment only group: 60 min standard treatment. 20 minute of worm-up exercise and 40 minute of traditional occupational therapy. Traditional occupational therapy include spasticity-reducing activity, bilateral hands activity and hand training task.
15933472|NCT03392467|Biological|PNEUMOSTEM|human umbilical cord blood-derived mesenchymal stem cells
15933473|NCT03392467|Other|Placebo|normal saline
15933474|NCT03392454|Procedure|T+LRTI|T+LRTI is the most commonly used procedure, it removes the entire trapezium
15968753|NCT03121300|Other|Toxicity|Toxicity Evaluation
15933475|NCT03392454|Procedure|PT+TI|The PT+TI is less invasive than the T+LRTI as only part of the trapezium is removed
15933476|NCT03392441|Other|Insulin Deprivation in Type 1 Diabetic Patients|Type 1 Diabetic Patients requiring insulin will have insulin stopped for a short period of time (4-6 hours)
15933477|NCT03392428|Other|177Lu-PSMA617|"Patients randomised to the 177Lu-PSMA617 arm will receive 6-8.5GBq of 177Lu-PSMA617 by intravenous injection once every 6 weeks until progressive disease, prohibitive toxicity or a maximum of 6 cycles.
~The first dose will be administered at 8.5GBq, reducing by 0.5GBq with every cycle given (i.e. to 6.0GBq on the sixth cycle, if reached). In some patients who have an exceptional response, treatment will be paused but can be re-commenced up to the maximum of 6 cycles upon progression."
15933478|NCT03392428|Drug|Cabazitaxel|"Patients randomised to the Cabazitaxel arm will receive 20mg/m2 Cabazitaxel by intravenous infusion once every 3 weeks until progressive disease, prohibitive toxicity or a maximum of 10 cycles.
~Patients in this arm will also receive prednisolone 10mg orally per day for the duration of their cabazitaxel treatment."
15933479|NCT03392415|Procedure|CTO PCI|attempted percutaneous coronary intervention of the chronic total coronary occlusion
15933480|NCT03392389|Biological|mRNA-1653|Escalating dose levels
15933481|NCT03392389|Other|Placebo|Saline
15933482|NCT03392376|Drug|Haloperidol Injection|ICU patients with diagnosed delirium are treated with 2,5mg haloperidol x 3 daily intravenously with additional as needed doses to a maximum of 20mg/daily.
15933483|NCT03392376|Other|Saline (0,9%)|ICU patients with diagnosed delirium are treated with 0,5ml isotonic saline x 3 daily and as needed doses to a maximum of 4ml/daily, corresponding to the algorithm in the experimental arm.
15933484|NCT03392363|Device|Recordings of Infants and Children's Cough Sounds|Smartphone recordings of the cough sounds of infants and children presenting to a participating site with signs or symptoms of respiratory disease.
15933485|NCT03392350|Behavioral|Physician Body Scan Consultation with Behavioral Intervention|The RENEW™ program consisted of 7 bi-monthly face-to-face web sessions over 16-18 weeks followed by an average of 15 monthly check-in sessions (maintenance) over 80 weeks.This included modules on responding to stress, enhancing effects of relaxation, nourishing theimmune system, physical activity, and social support.
15933486|NCT03392337|Device|Narrowband UVB phototherapy|Ultraviolet B phototherapy
15933487|NCT03392324|Device|PRIMA|Implantation of PRIMA device
15933488|NCT03392311|Drug|Calcipotriol ointment|The topical treatment in the study was calcipotriol ointment(Dovonex;LEO Laboratories Ltd, Ireland) twice daily for 12 weeks.
15933489|NCT03392311|Biological|adipose-derived multipotent mesenchymal stem cells|AD-MSCs(adipose-derived multipotent mesenchymal stem cells) were infused intravenously at a dose of 2 million cells/kg.
15933490|NCT03392298|Drug|Colla corii asini|15g Colla corii asini granule, once daily for 4 weeks
15933491|NCT03392285|Device|Internal fixation or hip arthroplasty|Patients treated according to the routine at the orthopedic department with screw fixation of an undisplayed femoral neck fracture or hip arthroplasty for a displaced femoral neck fracture.
15933492|NCT03392272|Device|Using of Tisseel fibrin glue|Using of Tisseel fibrin glue instead of sutures in Müller's Muscle-Conjunctival Resection (MMCR) surgeries
15933493|NCT03392272|Other|Using sutures|Using sutures in Müller's Muscle-Conjunctival Resection (MMCR) surgeries
15933494|NCT03392259|Behavioral|Smartphone app|Installment and use of smartphone app
15933495|NCT03392246|Drug|Osimertinib|"may stop (or inhibit) the growth of a cancer with a mutation in the EGFR gene"
15933496|NCT03392246|Drug|Selumetinib|"may enhance the effect of osimertinib to stop (or inhibit) the growth of a cancer with a mutation in the EGFR gene"
15933497|NCT03392233|Radiation|Stereotactic Body Radiation Therapy|Eligible patients will receive Stereotactic body radiation therapy (SBRT) for spinal metastatic lesion in 24Gy/3f(cervical vertebra) or 30Gy/3f (thoracic vertebra/lumbar vertebra) every other day and receive relevant system treatment at same time
15933498|NCT03392220|Procedure|Unilateral Neck Dissection|patient undergo unilateral (affected side) neck dissection, along with the excision of the laryngeal primary tumor
15933499|NCT03392220|Procedure|Bilateral Neck Dissection|patient undergo bilateral neck dissection, along with the excision of the laryngeal primary tumor
15933500|NCT03392207|Biological|Seasonal Influenza Vaccine|Trivalent, Fragmented, Inactivated Seasonal Influenza Vaccine (2018 Southern Hemisphere Season) produced at Butantan Institute
15933501|NCT03392194|Behavioral|Sleep hygiene intervention|The community-adapted SH intervention includes 2 group sessions. (1) teach the importance of sleep and the core components of SH; distribute and explain the daily sleep log (2) facilitate an open discussion where participants share challenges and experiences implementing a SH goal.
15933502|NCT03392194|Behavioral|Yoga intervention|Following the SH intervention, participants randomized to the SH+Y arm will participate in 8 weekly beginner level yoga classes. Classes will increase participants' skill and comfort with yoga postures and relaxing breathing exercises so that participants can adopt an evening yoga practice (10 weeks).
15933503|NCT03392181|Drug|18F-DCFPyL|To determine whether PET/MR utilizing PYL improves pre-operative staging of prostate cancer prior to radical prostatectomy compared to MRI alone.
15933504|NCT03392168|Drug|ARQ-151 cream 0.5%|0.5% active concentration
15933505|NCT03392168|Drug|ARQ-151 cream 0.15%|0.15% active concentration
15933506|NCT03392168|Drug|ARQ-151 vehicle cream|Vehicle cream
15933507|NCT03392155|Behavioral|Training & Nutrition|Exercise at moderate to high intensities and diet education/counseling
15933508|NCT03392142|Biological|tabelecleucel|Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.
15933509|NCT03392129|Other|Ai Chi|Children in the intervention group will perform 12 sessions (twice a week 40 minutes each session) of treatment with the Ai Chi Method, and educational intervention in relation to asthma.
15933510|NCT03392129|Other|Asthma education|Children assigned to the control group will receive, along with their parents, educational interventions in relation to asthma.
15933511|NCT03392116|Biological|NGM120|Subcutaneous Injection
15933512|NCT03392116|Other|Placebo|Subcutaneous Injection
15933513|NCT03392103|Drug|Raltitrexed|concurrent chemotherapy
15933514|NCT03392103|Radiation|postoperative radiotherapy|concurrent postoperative radiation therapy
15968754|NCT03121300|Other|Cardiac Assessment|Cardiac MRI Scan
15933515|NCT03392090|Other|More Good Days video&brief questionnaire|Help patients with advanced cancer think about what a good day means to them and to help them think about questions they may have for their physicians when discussing treatments
15933516|NCT03392077|Procedure|Caesarean section|Caesarean section will be done to deliver the baby
15933517|NCT03392077|Other|cervical dilatation|Cervical dilatation will be done by double gloves digital dilatation postpartum
15933518|NCT03392077|Other|No cervical dilatation|after delivery of the baby cervix will be remain closed
15933519|NCT03392064|Biological|AMG 119|Investigational, adoptive cellular immunotherapy for the treatment of small cell lung cancer
15933520|NCT03392051|Drug|ISIS 681257|Xmg dose administered as a subcutaneous injection
15933521|NCT03392051|Drug|Clopidogrel|75mg tablet administered orally
15933522|NCT03392038|Procedure|Thin ADM|Use of soft tissue allograft for root coverage
15933523|NCT03392038|Procedure|Thick ADM|Periodontal surgical procedure to coronally position the tissue over the ADM allograft
15933524|NCT03392025|Other|Flaxseed|Daily consumption of 30 grams flaxseed in adjunct to medical treatment for 3 months
15933525|NCT03392025|Other|the Mediterranean-like diet|Weekly Mediterranean-like diet menu in adjunct to medical treatment for 3 months
15933526|NCT03392025|Dietary Supplement|Placebo|Daily consumption of one capsule of wheat fiber as placebo in adjunct to medical treatment for 3 months
15933527|NCT03391999|Other|A questionnaire; CHU9D|Measuring Health Related Quality of Life
15933528|NCT03391986|Device|SEIRIN® Pyonex™ Acupuncture Needles|Needles will be placed on the right and left ear. Right ear - cingulate gyrus, thalamus, Point Zero, Shen Men, uterus. Left ear - cingulate gyrus, thalamus, Point Zero, Shen Men, cervix
15933529|NCT03391986|Procedure|12 mm Plasters|"12 mm (0.5). Latex-free Adhesives will be placed on the right and left ear. Right ear - cingulate gyrus, thalamus, Point Zero, Shen Men, uterus. Left ear - cingulate gyrus, thalamus, Point Zero, Shen Men, cervix"
15933530|NCT03391973|Drug|Pembrolizumab Injection|Pembrolizumab 200 mg will be administered as a 30 minute IV infusion Q3W.
15933531|NCT03391960|Device|Passive disinfection device|Add use of passive disinfection cap to existing central line needleless connector infection control procedure
15933532|NCT03391947|Procedure|semilunar coronally positioned flap|The description of this intervention has been already given before
15933533|NCT03391947|Procedure|coronally advanced flap|The description of this intervention has been already given before
15933534|NCT03391934|Drug|Cetuximab + FOLFIRI|Cetuximab 400 mg/m2 will be administered in the first dose and 250 mg/m2 will be administered in the next doses every week. Irinotecan will be administered 180 mg/m2 biweekly. Leucovorin will be administered 400 mg/m2 biweekly.Fluorouracil will be administered 400 mg/m2 push, and 2400 mg/m2 as 46-h infusion biweekly.
15933535|NCT03391921|Biological|Vaccine|All patients will receive the 9-valent vaccine against HPV (Gardasil9) intramuscularly: After a first open phase evaluating tolerability of Gardasil9, women will be randomized between two different doses schedules: in the first schedule, women will receive 2 doses at time 0 and 6 months and a third dose between 18-48 months if their antibody levels are insufficient; the second schedule will be 3 doses at 0, 2 and 6 months.
15933536|NCT03391908|Diagnostic Test|cardiac imaging tests|Patients will undergo non-invasive Cardiac Computed Tomography for assessment of coronary plaques and myocardial perfusion, and invasive intracoronary imaging tests (coronary angiography, Intravascular ultrasound, optical coherence tomography and FFR). If imaging will reveal existence of a significant coronary plaque, a percutaneous coronary intervention (PCI - stenting) will be performed.
15933537|NCT03391895|Other|Home based exercise program|Program will include deep diaphragmatic breathing exercises, local expansion exercise on the collapsed areas in scoliosis concave sides with elastic exercise bands, dynamic lumber stabilization exercises for core stabilisation, strengthening of interscapular muscles with elastic bands and stretching exercises for lumbar extensor, hip flexor and hamstring muscles. Exercises will be applied 2 sets of 10 repetitions and once a day.
15933538|NCT03391895|Other|Inspiratory Muscle Training|Threshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure after assessment of respiratory muscle strength for each patient every week.
15933539|NCT03391882|Drug|APL-130277|APL-130277: Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A
15933540|NCT03391882|Drug|subcutaneous apomorphine|subcutaneous apomorphine Part A- determine the dose; Part B- 28-day repeat dosing at the dose determined in Part A
15933547|NCT03391856|Drug|N-acetyl-L-cysteine (NAC)|NAC treatment for PT: 400mg p.o tid from day 60 to 90 post transplant
15933548|NCT03391856|Other|supportive therapy|prophylactic platelet transfusion was given when platelet count <20000/ul
15933549|NCT03391843|Drug|FOLFOXIRI+Cetuximab regimen|FOLFOXIRI+Cetuximab Irinotecan 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h +Cetuximab 500mg/m²,all on day 1 of each 2 weeks cycle
15933550|NCT03391830|Drug|Atorvastatin-Ascorbic acid|atorvastatin (80-mg loading dose given a mean 24 hours before procedure with another 40-mg dose approximately 2 hours before the procedure and for 3 days) plus ascorbic acid 500mg
15933551|NCT03391830|Drug|Placebo|Placebo
15933552|NCT03391817|Other|Fecal microbiota transplantation|Fecal microbiota transplantation administered in gastroscopy
15933553|NCT03391804|Drug|ALLN-177|ALLN-177 7,500 units (2 capsules) with each meal/snack by mouth 5 times per day for 12 weeks
15933554|NCT03391791|Genetic|Genetically engineered T Cell Receptors|No study drug is administered in this study. Subjects who received lentivirus-mediated genetically engineered T Cell Receptors in a previous trial will be evaluated in this trial for long-term safety and efficacy.
15933555|NCT03391778|Biological|GSK adoptive cell therapy|No study drug is administered in this study. Participants who received GSK adoptive cell therapy in a previous trial will be evaluated in this trial for long-term safety and efficacy.
15968755|NCT03121287|Other|Imaging Biomarkers|Whole lung volumetric CT scans
15933556|NCT03391765|Drug|ABBV-8E12|Participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW >59 kg, 4.7 mL/min or 282 mL/hr.
15933557|NCT03391765|Drug|Placebo solution for IV infusion on Day 15|0.9% NaCl injection/solution for infusion 500 mL; participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW >59 kg, 4.7 mL/min or 282 mL/hr.
15933558|NCT03391752|Combination Product|Integrated Nutrition Pathway for Acute Care|algorithm to guide care processes with respect to nutrition e.g. screening on admission, diagnosis with subjective global assessment, early treatment with medication pass of oral nutritional supplement
15933559|NCT03391739|Biological|CART-19 cells|CART-19 cells treat
15933560|NCT03391726|Other|CART-19 cells|CART-19 cells treat
15933561|NCT03391713|Behavioral|Poster|The poster includes the FAST symptoms but translated to the Malay language (Ce.P.A.T) Cakap tak jelas (slurred speech - Speech slurring) Perubahan muka (face changes - Face drooping) Anggota lemah (weak limbs - Arm weakness) Terus ke Hospital (straight to the hospital - Time to call 911
15933562|NCT03391700|Drug|Rocuronium(deep)|In the group with deep relaxation during surgery, rocuronium is given by continuous infusion (0.6 mg/kg/h).
15933563|NCT03391700|Drug|Rocuronium(moderate)|In the group with deep relaxation during surgery, rocuronium is given by bolus dose(0.15mg/kg) induced a train of four count of 1-2.
15933564|NCT03391687|Diagnostic Test|Amylase Test|body fluid amylase will be tested after radical gastrectomy in scheduled interval
15933565|NCT03391674|Other|Fecal Microbiota Transplantation|Fecal Microbiota Transplantation through oral capsules after omeprazole pre-treatment
15933566|NCT03391661|Behavioral|Pain neuroscience education patient exercise|Patients complete a 15 to 20-minute on-line exercise that inquires about 5 domains: the degree of central sensitization symptoms, catastrophizing and kinesiophobia, personality factors, stressors that triggered or exacerbated the pain, and adverse childhood experiences.
15933567|NCT03391661|Behavioral|Health behavior control intervention|Patients engage in a 15 to 20-minute on-line exercise examining their health behaviors in five domains: exercise, sleep, diet, hygiene, and social connections.
15933568|NCT03391648|Other|Observation|Observation only
15933569|NCT03391635|Device|Electroacupuncture|Participants will receive electroacupuncture at bilateral ST25, SP14 and ST37 for 30 minutes each time，3 times a week for 8 weeks.
15933570|NCT03391635|Device|TranscutaneousElectricNerveStimulation|Participants will receive transcutaneous electric nerve stimulation at bilateral ST25, SP14 and ST37 for 30 minutes each time，3 times a week for 8 weeks.
15933571|NCT03391622|Device|Calibrated Automated Thrombogram|blood samples will be collected . Thrombin generation in platelet-poor plasma will be measured by means of the Calibrated Automated Thrombogram (CAT).
15933572|NCT03391609|Drug|placebo infusion|Caesarian section will be performed under standard general anesthesia plus pre and intra operative saline infusion (placebo) in the same rate as dexmedetomedine starting 15 minutes before induction of general anesthesia and continue till peritoneum closure.
15933573|NCT03391609|Drug|Dexmedetomidine infusion|Caesarian section will be performed under standard general anesthesia plus pre and intra operative Dexmedetomidine infusion in a dose of 0.5mic/kg/hour starting 15 minutes before induction of general anesthesia and continue till peritoneum closure.
15933574|NCT03391596|Behavioral|Internet-based ACT intervention|The Internet-based ACT intervention is a 12-week program based on the processes of Acceptance and Commitment Therapy.
15933575|NCT03391596|Behavioral|Standardized rehabilitation|Standardized institutional rehabilitation in a rehabilitation center
15933576|NCT03391596|Behavioral|Support by voluntary caregiver associations|Support given by voluntary caregiver associations
15933577|NCT03391583|Other|Education|Participants in the education arm of the study will be provided with three PowerPoint presentations. Material for these slides has been adapted from material developed by the Ontario Neurotrauma Foundation. Topics to be addressed will surround post-traumatic headache and will include information regarding common symptoms, timeline for improvement, red- flags and when to seek medical attention
15933578|NCT03391570|Drug|COX-2 inhibitor|Celebrex 200mg/1cap 2 tablets, take medication an hour before surgery
15933579|NCT03391570|Drug|Placebo Oral Tablet|Ramnos 250mg/1cap 2 tablets, take medication an hour before surgery
15933580|NCT03391570|Procedure|Preoperative peritoneal biopsy|Preoperative peritoneal biopsy (1x1cm sized peritoneal tissue)
15933581|NCT03391570|Procedure|Single-port laparoscopic surgery|Single-port laparoscopic surgery with CO2 gas
15933582|NCT03391570|Procedure|Postoperative peritoneal biopsy|Postoperative peritoneal biopsy (1x1cm sized peritoneal tissue)
15933583|NCT03391557|Diagnostic Test|UE|All patients were examined by enhanced chest computed tomography (CT), the B-mode ultrasound and endobronchial ultrasound (EBUS)guided elastography before EBUS-TBNA. Each lymph node was assessed by describing the characteristics of the CT image (short diameter, texture, shape, boundary, mean CT value), B-mode ultrasound (short diameter, echo characteristic, shape, boundary) and ultrasound elastography (image type, grading score, strain rate, blue area ratio).
15933584|NCT03391544|Procedure|V4c toric ICL implantation surgery|The size and power of the V4c toric ICL were determined following the manufacturer's guidelines using a modified vertex formula. Emmetropia was the target refraction following surgery in all cases. Before surgery, three centration points were marked using the slit lamp while the patient, in sitting position, fixated on the center of the slit-lamp beam, which was narrowed as much as possible.
15933585|NCT03391531|Procedure|Bilateral subcostal TAP block|Echo-guided infiltration of a local anesthetic solution in the plane located between the transversus abdominis muscle and the rectus abdominis muscle
15933586|NCT03391518|Procedure|Water drinking test|Ingestion of 800 ml water in less than 5 minutes.
15933587|NCT03391505|Behavioral|Small-sided soccer game|The small-sided soccer game consists of a single bout (two times ten minutes) of small-sided soccer game (3v3) interspersed with a five minutes break.
15933588|NCT03391505|Behavioral|Walking soccer game|The walking soccer game consists of a single bout (two times ten minutes) of small-sided walking soccer game (3v3) interspersed with a five minutes break.
15933589|NCT03391505|Behavioral|Rest group watching soccer|The rest group watching soccer consists of watching a soccer game on a laptop (two times ten minutes) interspersed with a five minutes break.
15933592|NCT03391466|Biological|Axicabtagene Ciloleucel|A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously following a conditioning chemotherapy regimen of fludarabine and cyclophosphamide
15933593|NCT03391466|Drug|Platinum-containing salvage chemotherapy (eg, R-ICE) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.|Platinum-containing salvage chemotherapy (R-ICE, R-DHAP, R-ESHAP, or R-GDP as selected by treating investigator) followed by high dose therapy (eg, BEAM) and autologous stem cell transplant in responders.
15933594|NCT03391466|Drug|Cyclophosphamide|Administered intravenously
15933595|NCT03391466|Drug|Fludarabine|Administered intravenously
15933596|NCT03391440|Drug|morinidazole|morinidazole and sodium chloride injection (500 mg intravenous, twice daily for 14 days) with levofloxacin hydrochloride and sodium chloride injection (500 mg intravenous, once daily for the first week) sequential of levofloxacin hydrochloride tablets (500 mg (500 mg orally, once daily for the second week)
15933597|NCT03391427|Drug|Lidocaine|This group will receive lidocaine infusion
15933598|NCT03391427|Drug|Ketamine|This group will receive Ketamine infusion
15933599|NCT03391427|Drug|Lidocaine+ketamine|This group will receive mixture of ketamine and lidocaine infusion
15933600|NCT03391427|Drug|Saline|This group will receive saline infusion
15933601|NCT03391414|Drug|hypertonic bicarbonate|8.4% sodium bicarbonate inhaled
15933602|NCT03391414|Drug|sodium chloride|7% sodium chloride inhaled
15933603|NCT03391401|Procedure|Bariatric surgery|Any bariatric operation that is considered as a standard procedure in bariatric surgery (i.e. sleeve gastrectomy, roux-en-y gastric bypass, mini-gastric / one anastomosis gastric bypass, redo and revisional bariatric surgery).
15933604|NCT03391388|Radiation|3-Dimensional Conformal Accelerated Partial Breast Irradiation|Undergo 3D-CRT, catheter-based brachytherapy, or proton APBI
15933605|NCT03391388|Procedure|Interstitial Radiation Therapy|Undergo catheter-based brachytherapy APBI
15933606|NCT03391388|Other|Laboratory Biomarker Analysis|Correlative studies
15933607|NCT03391388|Radiation|Photon Beam Radiation Therapy|Undergo 3D-CRT APBI
15933608|NCT03391388|Radiation|Proton Beam Radiation Therapy|Undergo proton APBI
15933609|NCT03391388|Other|Quality-of-Life Assessment|Ancillary studies
15933610|NCT03391375|Biological|DNA-HIV-PT123 & AIDSVAX B/E|DNA-HIV-PT123 encodes clade C ZM96 Gag and gp140, CN54 Pol-Nef; AIDSVAX®B/E is a subtype B (MN) and subtype E (A244) HIV gp120 glycoprotein adsorbed onto aluminium hydroxide gel adjuvant
15933611|NCT03391362|Radiation|Stereotactic Radiation|Stereotactic radiation involves using a high dose of radiation that only targets the specific metastases
15933612|NCT03391323|Device|Medacta GMK Sphere® Medial-Pivot Knee Prosthesis|
15933613|NCT03391323|Device|Medacta GMK PS Posterior Stabilized Knee Prosthesis|
15933614|NCT03391310|Other|Honey (medicated)|Honey (medicated) dressing will be used in the experimental group
15933615|NCT03391297|Behavioral|Prolonged Exposure Therapy|PE consists of 10-15 treatment sessions. Treatment includes psychoeducation, in vivo exposure (i.e., confronting trauma-related situations and objects that are being avoided), imaginal exposure (i.e., revisiting and recounting traumatic memory) followed by processing (discussing the experience of revisiting the trauma memory, with a focus on new learning and changed beliefs or perspectives).
15933616|NCT03391284|Drug|acetominophen|INTRAVENOUS
15933617|NCT03391284|Drug|Acetaminophen|ORAL
15933618|NCT03391271|Other|photobiomodulation therapy (PBMT)|"Multiwave Locked System® (M6 laser, ASA srl, Arcugnano (VI), Italy)
~• The PBMT-group will receive twice-weekly laser sessions starting at first until the last week of chemotherapy (9-12 weeks depending on the type of chemotherapy)"
15933619|NCT03391271|Other|sham laser sessions|• The control group will undergo twice-weekly sham laser sessions starting at first until the last week of chemotherapy (9-12 weeks depending on the type of chemotherapy). The laser device will be placed on the same manner and for the same period of time on the identified body sites, but the device will not be switched on.
15933620|NCT03391258|Procedure|Bone Regeneration with GLAM technique|Bone regeneration with GLAM technique in full arch implant supported rehabilitation
15933621|NCT03391245|Diagnostic Test|3- Serum 25-Hydroxy Vitamin D level will be measured by Competitive ELISA technique|Serum 25-Hydroxy Vitamin D level will be measured by Competitive ELISA technique using CALBIOTECH (A life science company) kit, Catalog No.: VD220B
15933622|NCT03391232|Biological|PolyPEPI1018 CRC Vaccine|Colorectal Cancer Vaccine
15933623|NCT03391219|Drug|injection bevacizumab|1.25 mg/0.05 cc bevacizumab
15933624|NCT03391219|Drug|injection Combined Bevacizumab and Fasudil|1.25 mg/0.05 cc bevacizumab and 0.15mg/0.05 cc fasudil
15933625|NCT03391206|Diagnostic Test|Inbody 720|We investigated the diagnostic accuracy of breast cancer related lymphedema diagnosed by bioimpedance analysis (Inbody 720) and arm circumference measurement..
15933626|NCT03391193|Biological|Multi-dose Quadrivalent Influenza Vaccine|0.5 mL, intramuscular
15933627|NCT03391193|Biological|Single-dose Quadrivalent Influenza Vaccine|0.5 mL, intramuscular
15933628|NCT03391180|Drug|ICON Remineralization|A material used for the Remineralization of white spot lesions.
15933629|NCT03391180|Drug|CPP-ACPF|Casein phosphopeptide-Amorphous calcium phosphate fluoride used for the remineralization of white spot lesions.
15933630|NCT03391167|Procedure|Ultrasound guided erector spinae plane block|A high-frequency linear ultrasound transducer will be placed in a longitudinal parasagittal orientation 3 cm lateral to T9 spinous process. The erector spinae muscles will be identified superficial to the tip of T9 transverse process. The patient's skin will be anesthetized with 2% lidocaine. A 17-gauge 8-cm needle will be inserted using an in-plane superior-to-inferior approach to place the tip into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process. A total of 30 mL of 0.375% bupivacaine will be injected (maximum of 3mg/kg).
15933793|NCT03389958|Other|Counseling and provision of contraception|Provider training, availability of contraceptive methods
15933631|NCT03391167|Other|Standard Pain Followup and Monitorization|Numeric Rating Scale (NRS) pain score will be recorded from 20th minute in recovery room followed by 1.-3.-6.-12.-18.-24.hours. Intravenous meperidine administration at 0.5 mg / kg rescue analgesia was determined in patients with a NSR score of 6 and over in the postoperative collection room. It is planned that the patient will continue to follow the hourly NRS score in ward. Intramuscular diclofenac will be administered in this period if NRS 6 and if it is over, intravenous 0.5 mg / kg meperidine will be administered if NRS score is 6 or more after 2 hours. Salvage analgesic needs and times will be noted in detail, and the use of rescue analgesics, as well as NRS scores at designated hours, will be kept in a statistical evaluation.
15933632|NCT03391154|Drug|levothyroxin|90 female received levothroxine
15933633|NCT03391115|Behavioral|Storytelling Intervention for Patient Participants|The storytelling intervention consists of an audio-recorded interview with each patient participant prompted the participant to share their story with questions such as: tell me about your illness, tell me how your illness has affected your emotions, relationships, and spirituality. The interview transcripts will be used to co-create a 1 page patient story using these criteria:1) written in the first person; 2) nonjudgmental; 3) captures the participant's voice; 4) accurately reflects content of the interview; and 5) non-labeling. Once the story has been approved by the participant, I will upload it to the EHR.
15933634|NCT03391115|Behavioral|Storytelling Intervention for Nurse Participants|"Once the patient's story is uploaded to the EHR, automatic alerts will be sent to the participant's EHR-assigned nurses. For usability testing, nurse participants will 1) provide content expertise of the workflow processes, and 2) put the storytelling intervention through in-house usability testing to check the strength of EHR features and user-friendliness. Data will be collected with exit interviews and completion of a questionnaire: the System Usability Scale which asks them to rank their satisfaction with specific elements such as: how the story is labeled and presented in the EHR, any technical navigation EHR difficulties, and use of the material."
15933635|NCT03391102|Other|Observational study|
15933636|NCT03391089|Device|BBL Experimental Navigation System|Comparison of accuracy of screw placement using experimental system.
15933637|NCT03391076|Diagnostic Test|FilmArray Respiratory Panel|An Multi-PCR method which can detect 20 pathogens in 45 minutes.
15933638|NCT03391063|Other|polyamide|metal reinforced polyamide denture base material
15933639|NCT03391063|Other|heat cured acrylic resin|conventional heat cured acrylic resin denture base material
15933640|NCT03391050|Drug|APR-246|Intravenous infusion
15933641|NCT03391050|Drug|Dabrafenib|Oral administration
15933642|NCT03391037|Diagnostic Test|Internal Jugular Vein Distensibility|. 40 donor candidates for right lobe hepatectomy for living donor liver transplantation were enrolled. During period of hypovolemia (T0) left IJV scanned and measured. After a given fluid bolus in the form of ringer acetate 5 ml / Kg. ultrasonic and hemodynamic measurements were reassessed 10 minutes (T 10) after the fluid resuscitation
15933643|NCT03391024|Device|BBL Experimental Navigation System|Comparison of accuracy of screw placement using experimental system while navigated with clinically approved system.
15933644|NCT03391011|Device|BBL Experimental Navigation System|Comparison of accuracy of screw placement using experimental system while monitored by clinically approved system.
15933645|NCT03390972|Drug|Placebo|Placebo (NaCl 0.9%) TCI infusion
15933646|NCT03390972|Drug|Dexmedetomidine|Dexmedetomidine TCI 0.6 ng/ml and 1.2 ng/ml
15933647|NCT03390959|Other|Proprioceptive Training|"Individuals in the Trained Group will perform the training twice a week for 45 minutes and perform for a period of 12 weeks.
~The training is divided into a pre-training phase where general hip dissociation exercises and simple stretching of the hip flexor and extensor muscle groups, knee, foot and paravertebral are performed.
~The second phase is the proprioceptive training, where it will involve training of balance, sensitivity and proprioception, being used a circuit composed of 15 stations, whose time of stay in each station is 2 minutes.
~And finally the third stage are relaxation exercises, performed with breathing exercises associated with slow active movements of the joints."
15933648|NCT03390959|Other|Control Group|Will not be submitted to any physical intervention. It continues in your daily life with only phone monitoring.
15933649|NCT03390946|Drug|Poor responder group adjuvant chemotherapy|"Poor responder group (necrosis ≤ 90%)
~: week 0, 7 and 14, doxorubicin; week 2, 9 and 16, ifosfamde, week 4, 11, 18 and 19, methotrexate; wk 5, 12 and 20
~B. Resection of tumor
~C. Adjuvant chemotherapy
~Poor responder group (necrosis ≤ 90%)
~week 0, 7 and 14, doxorubicin; week 2, 9 and 16, ifosfamde, week 4, 11, 18 and 19, methotrexate; wk 5, 12 and 20
~Good responder group (necrosis > 90%)
~week 0 and 8, doxorubicin; week 2 and 10, ifosfamide; week 4, 5, 12 and 13, methotrexate; week 6 and 14, cisplatin"
15933650|NCT03390946|Drug|Good responder group adjuvant chemotherapy|"Good responder group (necrosis > 90%)
~: week 0 and 8, doxorubicin; week 2 and 10, ifosfamide; week 4, 5, 12 and 13, methotrexate; week 6 and 14, cisplatin"
15933651|NCT03390933|Drug|Fluoxetine|Patients enrolled into Phase II will be prescribed 2 weeks of short-acting fluoxetine 20 mg and will be instructed to take the prescription daily for 2 weeks. Then patients will be prescribed 10 additional weeks of 90 mg (weekly) fluoxetine and will be observed taking it once weekly at the dialysis unit. At the end of the 12 week study period, participants will be provided 4 additional weeks of 90 mg fluoxetine in order to provide sufficient time to follow up with their primary care physician or nephrologist.
15933652|NCT03390920|Other|Umbilical Allograft|The umbilical allograft is regulated by the FDA and comes from a lab that is FDA registered.
15933653|NCT03390907|Device|Hybrid APC|Following standard EMR Hybrid Argon Plasma Coagulation (APC) of the base and edges of the polypectomy site to fulgurate any potential microscopic residual disease.
15933654|NCT03390881|Other|Fasting condition|Subjects will fast over the whole experimental period (480 min)
15933655|NCT03390881|Other|Sugar condition|After a 2-h fasting state, subjects will ingest every hour a drink containing 70% carbohydrate, 15% fat and 15% protein and providing 1.5 X hourly resting energy requirement.
15933656|NCT03390881|Other|Fat condition|After a 2-h fasting state, subjects will ingest every hour a drink containing 70% fat, 15% carbohydrate and 15% protein and providing 1.5 X hourly resting energy requirement.
15933770|NCT03390166|Biological|Licensed influenza vaccine|The comparator licensed influenza vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.
15933823|NCT03389685|Biological|Platelet Rich Plasma|Pure PRPII®, leukocyte-poor, platelet rich plasma
15933657|NCT03390868|Behavioral|Web-based training for staff|This web-based training program is focusing on strengthening the carers' communication skills. Video lectures on the definitions, characteristics and causes of challenging behavior will be given. Video lectures will also be given on the importance of the carers' views on their values, emotions, abilities and attitude towards people with intellectual disabilities and on the impact that workplace culture and environmental factors have on the quality of interactions. The program also includes written cases that gives the participants opportunities to reflect upon approaches supporting a successful interaction. It also covers factors to consider when mental illness and challenging behavior occur. The time to complete the web-based training program is estimated at approximately ten hours.
15933658|NCT03390855|Other|Broccoli sprouts|
15933661|NCT03390829|Other|semi-directed interviews|semi-directed interviews
15933662|NCT03390816|Other|Nutritional assessment|Observational
15933663|NCT03390803|Other|effect of hemifacial spasm on intraocular pressure|To evaluate the effect of Hemifacial spasm on Intraocular pressure measurement.
15933664|NCT03390790|Drug|Lidocaine gel 2%|If assigned to this intervention via randomization, participants will receive lidocaine (numbing) gel prior to their urodynamics procedure.
15933665|NCT03390790|Other|Standard lubricant gel|If assigned to this intervention via randomization, participants will receive standard lubricant gel prior to their urodynamics procedure.
15933666|NCT03390777|Procedure|surgery|surgery without the use of prgf
15933667|NCT03390777|Device|PRGF after surgery|surgery and application of PRGF
15933668|NCT03390764|Procedure|4:1 closure group|In this arm the incisions are closed by the 4:1-technique
15933669|NCT03390764|Procedure|RTL plus 4:1 closure group|In this arm the incisions are closed by a reinforced tension-line suture in addition to the 4:1-technique
15933670|NCT03390751|Other|Data collection|The collection of data will be done by interrogation of the patient and his family / entourage and rereading of medical records
15933671|NCT03390738|Drug|Nivolumab|Intravenous nivolumab 240mg every 2 weeks until radiologically-documented disease progression, unacceptable toxicity as judged by investigators or patient withdrawal
15933672|NCT03390725|Behavioral|A Healthy School Start Plus intervention|Intervention for prevention of childhood overweight and obesity in disadvantaged areas through parental support in the school setting
15933673|NCT03390712|Drug|Paliperidone Palmitate|Monthly injections
15933674|NCT03390712|Drug|Risperidal Consta|Bi-weekly injection
15933675|NCT03390712|Drug|Antipsychotic|Any oral antipsychotic prescribed to be taken on a regular basis prior to the initiation of a long-acting injectable antipsychotic.
15933676|NCT03390699|Diagnostic Test|Microbial profile|microbiological testing
15933677|NCT03390686|Drug|Bevacizumab|15 mg/kg IV every 3 weeks on Day 1
15933678|NCT03390686|Drug|HD204|15 mg/kg IV every 3 weeks on Day 1
15933679|NCT03390686|Drug|Carboplatin|Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles
15933680|NCT03390686|Drug|Paclitaxel|Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles
15933681|NCT03390673|Drug|HD204|Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
15933682|NCT03390673|Drug|Avastin|Single-Dose 1mg/kg body weight by 90 minute intravenous infusion
15933683|NCT03390660|Other|WIC program participation|WIC program is a welfare program in the U.S. to provide nutritional supplements to low-income women, infants, and children.
15933684|NCT03390647|Drug|E6130|Oral dose
15933685|NCT03390647|Drug|Placebo|E6130-matched placebo
15933686|NCT03390634|Other|Gastroesophageal reflux symptoms questionnaires|Reflux Disease Questionnaire (RDQ) Reflux Symptoms Index (RSI) Gastroesophageal Reflux Disease Health-Related Quality of Life (GORD-HRQL)
15933687|NCT03390608|Drug|Endocrine therapy|Endocrine treatment versus no endocrine therapy (in women with hormone receptor positive1 disease).
15933688|NCT03390608|Radiation|Radiotherapy|Radiotherapy versus no radiotherapy.
15933689|NCT03390608|Drug|Herceptin|Trastuzumab versus no trastuzumab (in women with HER2-positive disease).
15933690|NCT03390608|Drug|Chemotherapy|Chemotherapy versus no chemotherapy.
15933691|NCT03390608|Procedure|Type of breast cancer surgery|Type of surgery (partial mastectomy, mastectomy, other).
15933692|NCT03390608|Other|Age at diagnosis|Age at diagnosis (<35, 35-<50, 50-<70, ≥70).
15933693|NCT03390608|Other|Screen detected tumor|Screening detected tumor (yes, no).
15933694|NCT03390608|Other|Menopausal status at diagnosis|Menopausal status (premenopausal, postmenopausal).
15933695|NCT03390608|Other|Tumor size|Tumor size (≤5 mm, 6-≤10 mm).
15933696|NCT03390608|Other|Estrogen receptor (ER) status|ER-status (positive, negative).
15933697|NCT03390608|Other|Tumor grade|Tumor grade (1, 2, 3).
15933698|NCT03390608|Other|HER2-status|HER2-status (positive, negative).
15933699|NCT03390608|Other|Intrinsic subgroups of breast cancer|Intrinsic subgroup proxy (Luminal A, Luminal B (HER2-negative), Luminal B (HER2-positive), HER2-positive (non-luminal), Triple negative).
15933700|NCT03390608|Other|Nodal status|N-status (N0, N1).
15933701|NCT03390595|Combination Product|avelumab 10mg/kg with carboplatin/gemcitabine|"Dosage and schedule:
~Avelumab 10mg/kg will be administered over 60 minutes in the experimental arm as follows:
~Intravenously every 2 weeks for two cycles.
~During carboplatin-gemcitabine treatment, on day +15 (carboplatin will be administered on day 1; gemcitabine on days 1 and 8), for six cycles. Intravenously every 2 weeks until progressive disease o intolerance.
~Intravenously every 2 weeks until progressive disease or intolerance.
~Carboplatin-gemcitabine will be administered for six cycles, every three weeks, with the following posology, according to the SmPC
~Carboplatin 5AUC day +1.
~Gemcitabine 1000mg/m2 day +1 and +8."
15933702|NCT03390595|Combination Product|carboplatin/gemcitabine alone|"•Carboplatin-gemcitabine will be administered for six cycles, every three weeks, with the following posology, according to the SmPC
~Carboplatin 5AUC day +1.
~Gemcitabine 1000mg/m2 day +1 and +8."
15933703|NCT03390582|Drug|Methimazole Pill|Hyperthyroidism patients are treated with Methimazole Pill according to the guidelines
15933704|NCT03390569|Behavioral|Exercise|The patients meet with a registered physiotherapist and receive individualized exercise programs starting the second week of treatment, and continuing up to 3 months later.
15933705|NCT03390556|Other|Nurse-delivered education|"The nurse will:
~Give the caregiver and child an overview of asthma, and discuss asthma control, triggers, and medications.
~Give caregivers information about asthma management written at or below 6th grade reading levels.
~Provide colored medication labels to distinguish controller from rescue medications following the action plan color scheme (green for controller medications, red for rescue medications). Teach-back methods will be used to elicit understanding of correct indications of use.
~Demonstrate MDI/spacer technique with teach-back.
~Discuss age-appropriate caregiver and child responsibility for asthma management within the family, with an overview of transitioning responsibility.
~Ask patients to make a 1 month follow-up appointment for asthma care."
15933706|NCT03390543|Device|Sono with Device|In Group D, simple needle guide device was attached to the sono probe. Device was designed to assist the detection of the puncture site. After induction of anesthesia, both the device and sono-guided internal jugular vein catheterization was performed.
15933707|NCT03390543|Device|sono only|In Group S, simple needle guide device was not attached to the sono probe. After induction of anesthesia, only sono-guided internal jugular vein catheterization was performed.
15933708|NCT03390530|Drug|Thyroxine|8 µg/kg/day divided into two doses intravenous every 12 hours
15933709|NCT03390530|Drug|Placebo|Placebo
15933710|NCT03390517|Device|Fluorescence angiography with indocianyne green|The fluorescence angiography was performed after mobilization of the bowel, transection of the rectum, division of the rectal and colon mesentery and central vessels, before specimen extraction or resection and creation of the anastomosis. This site was selected by the surgeon using his or her best judgment and typical standard of care assessment. After this selection, the anesthesiologist administered a bolus of 1 to 2 ml indocianyne green intravenously. Perfusion of the colon was visualized and assessed via fluorescence angiography and the line of demarcation between perfused and nonperfused tissue was noted and compared with the initial planned transection point.
15933711|NCT03390504|Drug|Erdafitinib|Participants will swallow erdafitinib tablets orally at a starting dose of 8 mg.
15933712|NCT03390504|Drug|Vinflunine|Participants will receive vinflunine 320 mg/m^2 as a 20-minute intravenous infusion.
15933713|NCT03390504|Drug|Docetaxel|Participants will receive docetaxel 75 mg/m^2 as a 1 hour intravenous infusion.
15933714|NCT03390504|Drug|Pembrolizumab|Participants will receive pembrolizumab 200 mg as a 30-minute intravenous infusion.
15933715|NCT03390504|Device|Fibroblast Growth Factor Receptor inhibitor Clinical Trial Assay (FGFRi CTA)|FGFRi CTA will be used to determine molecular eligibility.
15933716|NCT03390491|Behavioral|OnTrack>TheGame (OTG)|OTG clients will be informed that the game can be played on a computer or a tablet and the time estimate for completing the game is approximately 5-8 hours. OnTrack>The Game offers players the opportunity to immerse in a fictional neighborhood that centers around four domains for supportive recovery as defined by SAMHSA: health, home, purpose and community. The player interacts with other game characters including new acquaintances, friends/peers, a family member, and a treatment team, allowing the player to practice social and communication skills, while fostering personal relationships and building a support network. Additionally, the game provides players with helpful resources including psychoeducation materials and videos of real people who have experienced a first episode of psychosis, sharing their stories of hope and recovery. As a whole, the game provides a safe environment to promote goal attainment and recovery.
15933717|NCT03390491|Behavioral|Recovery Videos (RV)|As described, RV clients will have access to a website that includes recovery videos and static psychoeducation materials. In this condition, mental health providers will also ask about possible reactions to viewing the recovery videos and information on the website.
15933718|NCT03390478|Other|Combined Intervention Group|Experimental: Combined Intervention Program is composed by a Cognitive Stimulation Program (CSP), a Physical Activity Program (PAP) and Animal Assisted Therapy (AAT). During the PAP participants that use rolling-walkers, will do PAP using the Auto-Blocking kit mechanism for rolling walkers (ABMRW).
15933719|NCT03390465|Drug|Fimasartan/Amlodipine combination drug, Hydrochlorothiazide|Fimasartan/Amlodipine combination drug, Hydrochlorothiazide
15933720|NCT03390452|Behavioral|Mobile Phone Messaging|"Parents of primary school children will receive Mobile Phone Messages regarding their children's oral hygiene maintenance and their positive dietary habits."
15933721|NCT03390439|Device|Nd-Yap 1340nm laser|Each part of the abdomen will be treated with a therapeutic modality. The ND-yap 1340-nm laser will be used in the following parameters: 90 mtz / cm2 nozzle, 90 mJ / mtz power, 2.5 Hz frequency, 3 ms pulse duration, 1 pass.
15933722|NCT03390439|Device|Microneedling|In the other segment of the abdomen, the dermaroller 2.5 mm will be applied, with ten to fifteen passes in the same direction and at least four crosses in the rolling areas.
15933723|NCT03390426|Drug|Mepivacaine|An ultrasound guided injection of mepivacaine superomedially to the femoral artery.
15933724|NCT03390426|Procedure|Perifemoral Injection of Local Anesthetic|An ultrasound guided injection of mepivacaine superomedially to the formal artery in an effort to numb the nerves that contribute to tourniquet hypertension intraoperatively.
15933725|NCT03390426|Drug|Saline|An ultrasound guided injection using a medication that does NOT numb any nerves called saline, or salt water.
15933726|NCT03390413|Procedure|Robot|Renal cancer treated with robotic surgery
15933727|NCT03390413|Procedure|Cryoablation|Renal cancer treated with cryoablation
15933728|NCT03390400|Device|Femtosecondlaser-assisted|Femtosecondlaser-assisted Cataract Surgery will be performed bilateral on the same day with different laser settings.
15933729|NCT03390400|Procedure|Anterior Capsulotomy|Cataract Surgery
15933730|NCT03390400|Procedure|Lens Fragmentation|Cataract Surgery
15933731|NCT03390387|Drug|Dexamethasone continuous|6 mg/m2, per os, in two divided doses per day q12 hours. 1-28 day (dose in the first few days is depending on the total tumor mass). From day 29 the dose of dexamethasone is reducing: days 29-31 - 3 mg/m2, days 32-34 - 1.5 mg/m2, days 35-36 - 0.75 mg/m2; then dexamethasone is discontinued completely.
15933732|NCT03390387|Drug|Dexamethasone intermittent|6 mg/m2, per os, in two divided doses per day q12 hours. Days: 1-14 (dose in the first few days is depending on the total tumor mass) and 22-28; days 15-21 - pause. From day 29 the dose of dexamethasone is reducing: days 29-30 - 3 mg/m2, days 31-32 - 1.5 mg/m2, then dexamethasone is discontinued completely.
15933790|NCT03389997|Diagnostic Test|nasal swabs|Iterative nasal swabs will be performed to screen for virus shedding
15933791|NCT03389984|Diagnostic Test|cutaneous|SKIN BIOPSY
15968877|NCT03120520|Drug|Plecanatide|
15933733|NCT03390387|Drug|Dexamethasone|"Induction: 6 mg/m2, per os, in two divided doses per day q12 hours. 1-28 day (dose in the first few days is depending on the total tumor mass). From day 29 the dose of dexamethasone is reducing: days 29-31 - 3 mg/m2, days 32-34 - 1.5 mg/m2, days 35-36 - 0.75 mg/m2; then dexamethasone is discontinued completely.
~Consolidation: 6 mg/m2 per os, in two divided doses per day q12 hours. Weeks 13-14 (days 85-98), weeks 21-22 (days 141-154), weeks 29-30 (days 197-210), weeks 37-38 (days 253-260), weeks 45-46 (days 309-316), weeks 53-54 (days 365-372).
~Maintenance therapy: 6 mg/m2, per os, in two divided doses per day q12 hours, for 10 days followed by quick discontinuation during 3 days. Weeks 61-62, 69-70, 77-78, 85-86, 93-94."
15933734|NCT03390387|Drug|Methylprednisolone|"Induction: 60 mg/m2, per os, in two divided doses per day q12 hours. 1-28 day (dose in the first few days is depending on the total tumor mass). From day 29 the dose of dexamethasone is reducing: days 29-31 - 30 mg/m2, days 32-34 - 15 mg/m2, days 35-36 - 8 mg/m2; then methylprednisolone is discontinued completely.
~Consolidation: 60 mg/m2 per os, in two divided doses per day q12 hours. Weeks 13-14 (days 85-98), weeks 21-22 (days 141-154), weeks 29-30 (days 197-210), weeks 37-38 (days 253-260), weeks 45-46 (days 309-316), weeks 53-54 (days 365-372).
~Maintenance therapy: 60 mg/m2, per os, in two divided doses per day q12 hours, for 10 days followed by quick discontinuation during 3 days. Weeks 61-62, 69-70, 77-78, 85-86, 93-94."
15933735|NCT03390387|Drug|Daunorubicin|Induction: 45 mg/m2, intravenously, for 6 hours on days 8 and 22. Consolidation: 30 mg/m2, intravenously, for 6 hours on days 44, 65 (consolidation S1); 107, 121 (consolidation S2); and 163 (consolidation S3).
15933736|NCT03390387|Drug|Idarubicin|Induction: 10 mg/m2, intravenously, for 6 hours on days 8 and 22. Consolidation: 8 mg/m2, intravenously, for 6 hours on days 44, 65 (consolidation S1); 107, 121 (consolidation S2); and 163 (consolidation S3).
15933737|NCT03390387|Drug|Bortezomib|1.3 mg/м2, intravenously, bolus injection. Days 85, 89, 92, 96 (consolidation S1); 141, 145, 148, 152 (consolidation S2) and 197, 201, 204, 208 (consolidation S3).
15933738|NCT03390387|Drug|Second phase of induction|Cyclophosphamide (1,000 mg/m2, intravenously, for 1 hour - days 43 and 71); Cytarabine (75 mg/m2/day, intravenously, bolus injection. Four blocks of 4 days each, days 46-48, 52-55, 59-62, and 66-69); 6-mercaptopurine (60 mg/m2/day, per os, days 43-71); Triple intrathecal therapy (days 52 and 66)
15933739|NCT03390387|Drug|Standard induction therapy|Dexamethasone (6 mg/m2, p/o; 1-29 days); Daunorubicin (45 mg/m2, i.v.; day 8 and 22); Vincristine (1.5 mg/m2, i.v.; days 8, 15, 22, 29 and 36); Triple intrathecal therapy (Methotrexate/Cytarabine/Prednisone; days 0/1, 8, 15, 22, 29 and 36)
15933740|NCT03390387|Drug|Standard consolidation therapy|Consolidation consists of 3 phases: S1, S2 and S3. Each phase is a 6-week therapy with 6-mercaptopurine (50 mg/m2 per day, daily, orally), methotrexate (30 мг/м2, i.m., weekly) and L-asparaginase (10 000 U/m2, i.m., weekly), followed by 2 weeks of re-induction with Vincristine (1.5 mg/m2, i.v., days 1 and 8 of reinduction) plus Dexamethasone (6 mg/m2, p/o, daily, for 10 days followed by quick discontinuation during 3 days). Daunorubicin (30 mg/м2, i.v., N2 during S1, N2 during S2 and N1 during S3). Triple intrathecal therapy (Methotrexate/Cytarabine/Prednisone) N12 (4 injections per each phase)
15933741|NCT03390374|Drug|Nystatin Oral|Nystatin oral suspension
15933742|NCT03390361|Device|Femtosecond Laser-assisted|Laser cataract surgery will be performed in one eye
15933743|NCT03390361|Procedure|Manual Cataract Surgery|Manual cataract surgery will be performed in contralateral eye
15933744|NCT03390348|Device|LENA Recorder|Use of the LENA recorder to document crying and fussing
15933745|NCT03390335|Other|Pressure|Subjects undergo altitude exposure, diving exposure, and return to altitude. Altitudes: 8,000, 10,000, 12,000, or 15,000 feet Dives: 60 or 100 feet of sea water
15933746|NCT03390335|Other|Breathing Gas|Subjects will breathe air, 35% Oxygen, Balance Nitrogen, or 100% Oxygen during the diving exposure
15933747|NCT03390322|Device|DiaGone™|Duodenal Glycemic Control™ using the DiaGone™ system
15933748|NCT03390309|Other|Partially Hydrolyzed Formula|Partially Hydrolyzed Whey Protein Infant Formula
15933749|NCT03390309|Other|Normal Formula|Normal Formula
15933750|NCT03390296|Biological|Anti-OX40 Agonist Monoclonal Antibody PF-04518600|Given IV
15933751|NCT03390296|Drug|Avelumab|Given IV
15933752|NCT03390296|Drug|Azacitidine|Given IV or SC
15933753|NCT03390296|Drug|Gemtuzumab Ozogamicin|Given IV
15933754|NCT03390296|Drug|Glasdegib|Given PO
15933755|NCT03390296|Drug|Glasdegib Maleate|Given PO
15933756|NCT03390296|Drug|Venetoclax|Given PO
15933757|NCT03390296|Drug|Azacitidine|Given IV or SC
15933758|NCT03390283|Other|Survey Administration|Complete online survey
15933759|NCT03390270|Other|Admission with NSTEMI|All patients admitted to Duke University Hospital with an NSTEMI
15933760|NCT03390257|Device|3NT flexible endoscope|The nasal anatomy will be accessed and viewed with the device during Balloon Sinus Dilation
15933761|NCT03390244|Device|Foldable Capsular Vitreous Body Implant|Vitrectomy augmented with the implantation of the FCVB implant
15933762|NCT03390231|Combination Product|Stem Cell Educator therapy|It briefly cocultures the patient's lymphocytes with CB-SCs in vitro, induces immune tolerance through the action of autoimmune regulator (AIRE, expressed by CB-SCs), returns the educated autologous lymphocytes to the patient's circulation, and restores immune balance and homeostasis.
15933763|NCT03390218|Behavioral|Therapy Assistance Online|protocoled on-line educational modules, with brief therapist interaction and practice support with a mobile app.
15933764|NCT03390218|Behavioral|Treatment as usual|Individual and group therapy, generic in nature
15933765|NCT03390205|Diagnostic Test|Optical coherence tomography angiography under dark and light adaptation|Optical coherence tomography angiography under dark and light adaptation with pupil dilatation
15933766|NCT03390192|Device|Dual-mode stimulation|1Hz rTMS over contralesional primary motor cortex and anodal tDCS over ipsilesional primary motor cortex are simultaneously simulated.
15933767|NCT03390192|Device|Single sham stimulation|1Hz rTMS over contralesional primary motor cortex and sham tDCS (no stimulation) over ipsilesional primary motor cortex are simultaneously simulated.
15933768|NCT03390179|Drug|Steroid Drug|mesure of the glucose concentration
15933769|NCT03390166|Biological|GPO Tri Fluvac vaccine|The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.
15933792|NCT03389971|Procedure|catheter-directed thrombolysis|catheter-directed thrombolysis with commercially available multi-sidehole catheter or USAT catheter
15933771|NCT03390153|Other|semi flexible socket|The investigators will analyze the subject's gait by trained visual diagnosis and video gait analysis, to determine comfort and safety. Any modifications will be done at this time. Once the subjects, student, and faculty investigators are satisfied with the overall fit of prostheses, a student investigator will insert force sensors into the socket to evaluate pressure. In the 'Comfort Test', walk at a self-selected pace on a treadmill for 10 minutes. Subjects will then perform a single stance activity on a Balance Master. Investigators will remove the force sensors and do one final safety check of prostheses before each subject takes their definitive socket home. Subjects will be required to wear the prosthesis given to them for one week before returning for a follow up appointment.
15933772|NCT03390153|Other|rigid fiber socket|The investigators will analyze the subject's gait by trained visual diagnosis and video gait analysis, to determine comfort and safety. Any modifications will be done at this time. Once the subjects, student, and faculty investigators are satisfied with the overall fit of prostheses, a student investigator will insert force sensors into the socket to evaluate pressure. In the 'Comfort Test', walk at a self-selected pace on a treadmill for 10 minutes. Subjects will then perform a single stance activity on a Balance Master. Investigators will remove the force sensors and do one final safety check of prostheses before each subject takes their definitive socket home. Subjects will be required to wear the prosthesis given to them for one week before returning for a follow up appointment.
15933773|NCT03390140|Behavioral|ReInventing Yourself after SCI structured group CBT|ReInventing Yourself after SCI intervention integrates positive psychotherapy concepts into structured group cognitive behavioral therapy (CBT) to develop optimistic self-efficacy beliefs, thereby strengthening resilience to emotional distress, enhancing a sense of well-being and promoting a more active lifestyle. The intervention consists of six weekly two-hour facilitator-led sessions that include didactic presentations of eight core skills and related experiential exercises with extensive group discussion.
15933774|NCT03390140|Behavioral|ReInventing Yourself after SCI study-specific workbook|A study-specific workbook that incorporates positive psychotherapy concepts to develop optimistic self-efficacy beliefs, thereby strengthening resilience to emotional distress, enhancing a sense of well-being and promoting a more active lifestyle.
15933775|NCT03390140|Behavioral|ReInventing Yourself after SCI YouTube videos|YouTube videos containing the content of the ReInventing Yourself after SCI structured group CBT sessions
15933776|NCT03390127|Other|PEEP|After LMA Supreme™ insertion, it's proper position is confirmed. Then, PEEP of 7 cmH2O is applied during mechanical ventilation.
15933777|NCT03390114|Behavioral|SHUTi|SHUTi consists of six, 40-minute, weekly sessions during which the intervention components of stimulus control, sleep restriction, sleep hygiene, cognitive restructuring, and relapse prevention are delivered. Each SHUTi session has the same structure: the main content, a homework screen with options, and a summary of the main points.
15933778|NCT03390101|Drug|BCD-085 Q2W|"In Arm 1, the test drug BCD-085 will be used at a dose of 120 mg given as two SC injections according to the following schedule: once a week for the first 3 weeks (induction treatment) and then once every 2 weeks through Week 10.
~On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label patients will receive BCD-085 through week 50. The follow-up will continue through week 54."
15933779|NCT03390101|Drug|BCD-085 Q4W|In Arm 2, and then once every 4 weeks through Week 10. On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 2 will be given BCD-085 once every 4 weeks through week 50. The follow-up will continue through week 54.
15933780|NCT03390101|Drug|Placebo|"In Arm 3, patients will be given two SC injections of placebo (1.0 mL each) according to the following schedule: on Day 1 of weeks 0, 1, 2 and then once every 2 weeks through Week 10.
~On Week 12, the treatment efficacy will be assessed with a PASI75 score, and the therapies will be unblinded. During the open-label period, patients from Arm 3 will receive BCD-085 at weeks 12, 13, 14 and then once every 4 weeks through week 50. The follow-up will continue through week 54."
15933781|NCT03390062|Drug|Apatinib|Apatinib, also known as YN968D1, is a tyrosine kinase inhibitor that selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR2, also known as KDR). It is an orally bioavailable, small molecule agent which is thought to inhibit angiogenesis in cancer cells; specifically apatinib inhibits VEGF-mediated endothelial cell migration and proliferation thus blocking new blood vessel formation in tumor tissue.
15933782|NCT03390049|Device|Fractional CO2 Laser Treatment|After obtaining a negative urine pregnancy test, each subject assigned to the fractional CO2 laser treatment arm will undergo laser sessions with the fractional microablative CO2 laser system (SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Florence, Italy) using the flat vulvar probe with the following settings: dot power 26 Watts, dwell time 1000 μs, dot spacing 1000 μm, and smart stack parameter from 1 to 3. Stack 1 is used at baseline; stack 3 is used 6 and 12 weeks after.
15933783|NCT03390049|Device|Sham Laser Treatment|After obtaining a negative urine pregnancy test, each subject assigned to the sham laser treatment arm will undergo laser sessions with the fractional microablative CO2 laser system (SmartXide 2 V 2 LR, MonaLisa Touch, DEKA, Florence, Italy) using the flat vulvar probe. However, these sham laser sessions will administer no fractional CO2 laser energy. To increase the likelihood that subjects assigned to sham laser remain blinded to treatment arm assignment during the study, MonaLisa Touch will provide a software package with settings that allow for reproduction of the sounds generated during a regular fractional CO2 laser session but using 0 Watts of power.
15933784|NCT03390036|Drug|Cingal|A chemically cross-linked sodium hyaluronate supplied as a 4-mL unit dose with a nominal 18 mg of triamcinolone hexacetonide (TH)
15933785|NCT03390036|Device|Monovisc|A chemically cross-linked sodium hyaluronate supplied as a 4-mL unit dose
15933786|NCT03390036|Drug|Triamcinolone Hexacetonide|20 mg/ml supplied as 1 mL unit dose of Triamcinolone Hexacetonide
15933787|NCT03390023|Behavioral|Focus Group|Groups will last 60 to 90 minutes. Focus groups will be moderated by KUMC Juntos staff who are formally trained to conduct focus groups. General topics to be covered in focus groups include: attitudes, preferences and knowledge about prenatal care, clinical trial participation, and nutritional supplement use. Focus groups will be conducted in Spanish.
15933788|NCT03390010|Drug|Misoprostol + syntocinon and methergine drugs|medical prophylaxis against postpartum atony and postpartum hemorage by giving misoprostol plus syntocinon and methergine
15933789|NCT03390010|Drug|Syntocinon plus methergine drugs|medical prophylaxis against postpartum atony and postpartum hemorage by giving syntocinon and methergine
15933794|NCT03389945|Procedure|25G Dural Puncture Epidural Block|"Dural puncture epidural analgesia using a 25G pencil point spinal needle at a lumbar interspace.
~Then 20ml of bupivacaine 0.125% + fentanyl 2ug/ml will be injected in the epidural space."
15933795|NCT03389945|Procedure|27G Dural Puncture Epidural Block|"Dural puncture epidural analgesia using a 27G pencil point spinal needle at a lumbar interspace.
~Then 20ml of bupivacaine 0.125% + fentanyl 2ug/ml will be injected in the epidural space."
15933796|NCT03389932|Behavioral|Patient-Guided|Patients in the ET@Home study condition will receive four modules of video and print transplant education over a 6-month period. After each module is mailed, 3 postcards are mailed weekly that recap important transplant educational content covered within the videos. Patients will have the opportunity to participate in a texting component of ET@Home that also sends small pieces of educational content and learning reminders by phone each week.
15933797|NCT03389919|Biological|MSC administration (intraosseal)|MSCs will be administered under local anesthesia to the iliac crests after receiving informed consent from the patient.
15933798|NCT03389906|Other|Gold|Approximately 72000, 20-40 my-meter diameter, sterilised gold particles (=20 mg) will be provided in vials (The Berlock® Gold Implants). 5-10 ml of synovial fluid is aspirated (20G needle) from most affected OA-knee. The vial of gold particles are mixed with the synovial fluid, and the mix of gold and synovial fluid is injected intra-articularly into the patients knee.
15933799|NCT03389893|Drug|Dupilumab|Dupilumab, an interleukin (IL)-4 receptor alpha (IL-4Rα) antagonist, is indicated for the treatment of adult patients with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable. (FDA approved on March 28, 2017.)
15933800|NCT03389893|Drug|Placebo|Placebo will contain the identical formulation as the dupilumab formulation without the active mAb and will be given by exactly the same route and schedule through Day 28.
15933801|NCT03389880|Procedure|Total knee arthroplasty|A surgical procedure in which parts of the knee joint are replaced with artificial parts (prostheses)
15933802|NCT03389880|Procedure|Patellar denervation|circumpatellar electrocautery with monopolar coagulation diathermy
15933803|NCT03389867|Dietary Supplement|Kaempferia parviflora extract|
15933804|NCT03389854|Device|RestoreX PTT - randomized and open label|Penile traction therapy in the straight and bent positions
15933805|NCT03389854|Device|RestoreX PTT - open label phase only|Penile traction therapy in the straight and bent positions
15933806|NCT03389841|Other|Education|Education of the caregiver about early symptoms and signs of heart failure
15933807|NCT03389815|Drug|WX-0593 Tablets|tablets, dosage ranged from 30 mg to 300 mg, quaque die（QD）
15933808|NCT03389802|Biological|APX005M treatment for recurrent or refractory primary malignant CNS tumor patients|"APX005M dosing will begin at 0.1 mg/kg, the APX005M dose may be increased (0.3, 0.45, 0.6 mg/kg) or decreased (0.03 mg/kg) in subsequent cohorts until the MTD is reached or until dose level 3 (0.6 mg/kg) is complete without MTD being defined.
~APX005M will be administered at the assigned dose level every 21 days (3 weeks). Patients may continue to receive APX005M for 36 courses (approximately 2 years) or until disease progression, unacceptable toxicity or death, whichever occurs first."
15933809|NCT03389802|Biological|APX005M treatment for newly diagnosed DIPG patients|"The starting dose of APX005M for the DIPG patients will be one dose level below the RP2D determined in Stratum 1 patients. The dose may be decreased or increased to the RP2D established in Stratum 1.
~APX005M will be administered at the assigned dose level every 21 days (3 weeks). Patients may continue to receive APX005M for 36 courses (approximately 2 years) or until disease progression, unacceptable toxicity or death, whichever occurs first."
15933810|NCT03389789|Other|Oral glucose solution + maternal holding|Infant will receive both the oral glucose solution and the contact with the mother
15933811|NCT03389789|Other|Breastfeeding|Infants will be breastfed
15933812|NCT03389789|Other|Oral glucose solution|Infant will receive only oral glucose solution without contact with the mother
15933813|NCT03389789|Other|Oral expressed breastmilk|Infant will receive only oral expressed breast milk without contact with the mother
15933814|NCT03389776|Procedure|Anesthesia|Occurrence and severity of postoperative sore throat could be determined by various factors other than the pressure of the cuff alone. In particular, cuff pressure measurement, duration of anaesthesia, airway manipulations e.g. multiple insertion attempts, could all be factors determining the occurrence of postoperative sore throat.
15933815|NCT03389763|Drug|Remifentanil|a rate of infusion will be increased by 50% every 5 minutes
15933816|NCT03389750|Drug|Intravenous Challege Drug|Intravenous administration of opioid drugs (oxycodone, oxymorphone, morphine, hydromorphone), for the purpose of comparison of their abuse potential among each other, and in comparison to placebo (saline).
15933817|NCT03389737|Behavioral|Counseling|Counseling on healthy behaviors with in person meetings.
15933818|NCT03389737|Behavioral|Counseling|Counseling on healthy behaviors with emails.
15933819|NCT03389724|Drug|Capoten®|ACE-I (Capoten®) will be given to patients in the Intervention arm with the start of chemotherapy, twice daily at a dose of 0.5 mg/kg/day (divided over 2 doses)
15933820|NCT03389711|Combination Product|DMARD´s and multidisciplinary treatment|"At study enrollment, medical history, disease-specific autoantibodies, ACR 1987 classification criteria for RA were applied. Medical evaluations were standardized and included at least 66 swollen and 68 tender joint counts, acute reactant-phase determinations , patient and physician reported outcomes, comorbidity established by record review, and treatment assessments (name, dose and schedule of all drug they were taking) along with an evaluation of persistence, at six-month intervals.
~Patients were evaluated by a single rheumatologist every two months during the first two years of follow-up, and every two, four or six months thereafter.
~Also the following scores: Michigan Hand Outcome Questionnaire (MHQ), Disabilities of the Arm, Shoulder and Hand Outcome Measure (DASH),Mayor Depressive Episodes (MDE) was defined using the Mini International Neuropsychiatric Interview and the severity of depressive symptoms was assessed with the Beck Depression Inventory (BDI-II)."
15933821|NCT03389698|Device|GRASP DCE-MRI|DCE-MRI termed Golden-angle Radial Sparse Parallel (GRASP) significantly improves both spatial and temporal resolution while enabling retrospective reconstruction with flexible temporal resolution.
15933822|NCT03389698|Device|3T Brain Scan|up to 60 minutes: 3T brain scan, a portion of which uses the GRASP DCE-MRI sequence (the first 21 minutes of the scan for CN cohorts and the first 9 minutes of the scan for the Amnestic Mild Cognitive Impairment cohort)
15933825|NCT03389672|Procedure|spinal anesthesia|For conventional spinal anesthesia, injection site was 1 cm lateral and 1 cm caudal to the spinous process, and the needle was directed cephalad and medially to the epidural-subarachnoid space by the operator. For modified method, we reduced the distance from 1cm to 0.5cm in each directions.
15933826|NCT03389672|Procedure|epidural anesthesia|For conventional epidural anesthesia, injection site was 1 cm lateral and 1 cm caudal to the spinous process, and the needle was directed cephalad and medially to the epidural-subarachnoid space by the operator. For modified method, we reduced the distance from 1cm to 0.5cm in each directions.
15933827|NCT03389672|Procedure|combined spinal-epidural anesthesia|For conventional combined spinal-epidural anesthesia, injection site was 1 cm lateral and 1 cm caudal to the spinous process, and the needle was directed cephalad and medially to the epidural-subarachnoid space by the operator. For modified method, we reduced the distance from 1cm to 0.5cm in each directions.
15933828|NCT03389659|Drug|vitamin D3|vitamin D3 400IU*5pills po. qd continue to disease progression
15933829|NCT03389659|Drug|Placebo|placebo 5 pills po. qd continue to disease progression
15933830|NCT03389646|Device|CERAMENT G V|"During the removal of hip and knee prostheses usually bone defects occur at the intramedullary canal of the tibia and or / femur and /or acetabulum. These bone defects are filled with CERAMENTTM|G or V during the re-implantation of the cementless or hybrid revision THA or TKA. CERAMENTTM|G or V can be directly injected into the intramedullary canal or bone defect at the acetabulum. Alternatively and preferably, the surface of the prostheses shafts can be used to transfer CERAMENTTM|G or V into the bone defects. For information of handling and mixing please see the attached instructions for use (IFU)."
15933831|NCT03389633|Other|rehabilitation|
15933832|NCT03389620|Drug|dexamethasone|0.8 mL of dexamethasone (10 mg/mL) will slowly be injected over a period of approximately 30 seconds
15933833|NCT03389607|Diagnostic Test|spinal anesthesia|before spinal anesthesia, before 5 min opening of tourniquet and 2 hr after operation SCUBE-1, MDA and TAC will measured from plasma
15933834|NCT03389594|Other|Surgical guide|Surgical Guide for this group will designed from 0.4mm voxel size
15933835|NCT03389581|Behavioral|awareness and anxiety|before operation awareness and anxiety will recorded with STAIX-I score
15933836|NCT03389568|Behavioral|singing-based music therapy program|A single 1-hour singing-based intervention is conducted with each primary caregiver of an ICU patient. The intervention is composed of three steps: 1) listening to a participant's preferred music and identifying his and her emotional states (15 minutes), (2) singing for emotional changes (30 minutes), and (3) discussing what he or she experiences during singing and identifying how they apply such experience to their personal use of music for emotional changes in his or her everyday life (15 minutes).
15933837|NCT03389555|Drug|vitamin C, vitamin B1, hydrocortisone|Vitamin C (1.5g) plus vitamin B1 (100mg) will be diluted in 100ml 0.9% NACL(normal saline) and administered IV every 6 hours for 4 days or until participant is discharged from the ICU. Hydrocortisone 50mg/ml will be administered via IV push over 1-2 minutes every 6hours for 4 days or until the patient is discharged from the ICU.
15933838|NCT03389555|Drug|Normal saline|Normal saline (0.9% NaCl solution) volume to match all components
15933839|NCT03389542|Procedure|Surgery|Early mitral valve repair
15933840|NCT03389542|Other|Clinical interview and echocardiography|Clinical interview and echocardiography every 6 months.
15933841|NCT03389516|Other|Polymem|wound care dressings
15933842|NCT03389516|Other|Lanolin|wound care oinment
15933843|NCT03389503|Procedure|Radial approach|Approach site for coronary angiography and coronary intervention
15933844|NCT03389490|Drug|Insulin Glargine 300 UNT/ML|Self titration of insulin glargine U300
15933845|NCT03389490|Drug|Neutral protamine hagedorn insulin|Self titration of NPH insulin
15933846|NCT03389477|Drug|Palbociclib|Palbociclib is an oral drug available as capsules (or as liquid suspension). The capsules should be taken with food
15933847|NCT03389477|Drug|Cetuximab|-Cetuximab must not be administered as an IV push or bolus
15933848|NCT03389477|Drug|Cisplatin|-Patients will receive cisplatin via intravenous (IV) infusion over 60 minutes.
15933849|NCT03389477|Radiation|Intensity-Modulated Radiation Therapy|-Once daily fractions Monday through Friday, with one additional fraction of RT administered on (preferably) Fridays
15933850|NCT03389477|Procedure|Tumor biopsy|"Tumor tissue will be collected at baseline and then after two cycles of neoadjuvant palbociclib monotherapy
~If the patient has been previously enrolled in Washington University's TAP protocol (head and neck bank, HRPO #201102323), tissue that has been banked may be accessed in lieu of fresh biopsy at baseline."
15933851|NCT03389477|Procedure|Peripheral blood draw|Baseline and post-treatment
15933852|NCT03389464|Behavioral|computer-based confrontation with dysfunctional beliefs|"Patients will be presented with a virtual agent confronting them with their dysfunctional core beliefs (e.g. You are worthless). Participants will be instructed to contradict these virtual agents (e.g. That's not true, I'm a wonderful person)."
15933853|NCT03389451|Drug|Ga-68 PSMA-HBED-CC PET|Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
15933854|NCT03389438|Biological|autologous Tcm cells immunotherapy|Autologous Tcm cells immunotherapy is to collect patient's own immune cells and infuse back into the patient's body after culture in vitro that can activate the anti-tumor immune response and achieve the purpose of cancer treatment.
15933855|NCT03389425|Behavioral|simplified intervention to modify physical activity, lifestyle, and eating behavior|16 week, behavioural weightloss intervention.
15933856|NCT03389412|Drug|Desmopressin|The children will be treated with 120 microgram/day the first two weeks. If the child is not completely dry, the dose will be increased to 240 microgram/day the rest of the study period (maximum eight weeks of treatment).
15933857|NCT03389412|Device|Conditional alarm|Eight weeks of treatment.
15933858|NCT03389386|Diagnostic Test|Blood withdrawal for laboratory analysis|"Participants in this study will have their peripheral blood sampled from the cubital vein and the total volume withdrawn for the purposes of this study will be no more than 22 mL per person.
~Parameters of interest in the laboratory analysis will include serum catestatin levels, NT-proBNP levels, hs-cTnI, parameters of inflammation and renal function as well as standard biochemistry and complete blood count (CBC) panels."
15933926|NCT03388827|Drug|Laminaria plus Misoprostol|Laminaria plus Misoprostol were inserted for 12 hours before Hysteroscopy
15933859|NCT03389386|Other|Standard-of-care treatment|Patients diagnosed with chronic heart failure will receive optimal standards of care in terms of pharmacologic management, according to their current clinical condition.
15933860|NCT03389386|Diagnostic Test|Transthoracic echocardiography (TTE)|Participants from both groups will undergo transthoracic echocardiography examination that will measure established hemodynamic parameters of systolic and diastolic cardiac function as well as parameters of LV and RV strain in the selected subset of patients.
15933861|NCT03389373|Device|GC Strep Mutans Saliva Sampling|Children who match inclusion criteria will have a saliva sample obtained which will act as a proxy for bacterial levels.
15933862|NCT03389360|Diagnostic Test|procalcitonin|assessing the frequency of rising procalcitonin associated with infectious complications in immunosuppressed LDLTRx.
15933866|NCT03389334|Other|massage|The techniques include myofascial release and manual active and passive stretching with the intention to lengthen overly contracted or shortened tissue, increase range of motion, and restore any malpositioning of structural landmarks as defined by its contralateral counterpart. By addressing the symptoms of the somatic dysfunction, you will in turn reduce the overall perceived pain in the body caused in these related tissues. The duration of each massage treatment session will be 45 minutes long and therapists will use a timer to ensure all subjects receive the same length of treatment. Patients will continue to receive treatment from the same therapist to maintain consistency of results.
15933867|NCT03389321|Drug|Riociguat (Adempas)|Riociguat film-coated tablets for oral administration at a strength of 1 mg
15933868|NCT03389321|Drug|Macitentan (Opsumit)|Macitentan film-coated tablets for oral administration at a strength of 10 mg
15933869|NCT03389308|Drug|diacerein 1% ointment|"Topically apply study medication to lesions identified by the Investigator that require.
~treatment"
15933870|NCT03389295|Radiation|Reduced Target Delineation and Radiation Doses|"The target volumes were delineated according to the treatment protocol defined as follows: the GTV of the primary tumor (GTV-P) included retropharyngeal lymph nodes, considering the common phenomena of integration, and the rest involved lymph nodes that were defined as GTV-N. For the GTV-P, involved retropharyngeal lymph nodes and intracavity lesions were delineated according to the post-IC volume, whereas the remainder of the involved tissues (eg, pterygopalatine fossa) were delineated according to the pre-IC volume of the primary lesion as shown by MRI. Post-IC volumes of involved neck lymph nodes were used for GTV-N delineation.
~The prescribed dose was 66 Gy to tumors above the slices of skull base or below the orapharynx with less than 5 mm retropharyngeal lymph nodes, or 70.4 Gy to tumors in other slices."
15933871|NCT03389282|Diagnostic Test|Tear Sampling|comprehensive eye exam, Schirmer test, break-up time, tear sampling
15933872|NCT03389269|Other|Meal test|240 min mixed meal test with aspiration using AspireAssist.
15933873|NCT03389256|Drug|Apatinib|Apatinib mesylate tablets 250 mg qd po, if the patient can tolerate the toxic side effects, adjust the dose to 500mg qd po after 1 week.
15933874|NCT03389256|Drug|EGFR-TKI|Imatinib tablets, 125 mg tid po; gefitinib tablets, 250 mg qd po; erlotinib tablets, 150 mg qd po
15933875|NCT03389243|Drug|Metamizol|in group M patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1,25 gram
15933876|NCT03389243|Drug|paracetamol|in group P patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1,25 gram
15933877|NCT03389243|Drug|paracetamol and metamizole|in group PM patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1,25 gram and paracetamol in a dose of 1 gram
15933878|NCT03389230|Biological|HER2(EQ)BBζ/CD19t+ T cells|Given via catheter
15933879|NCT03389230|Other|Laboratory Biomarker Analysis|Correlative studies
15933880|NCT03389230|Procedure|Leukapheresis|Undergo leukapheresis
15933881|NCT03389217|Device|Real-tDCS + rehabilitation programme|tDCS stimulation will be delivered using a constant current stimulator, with rechargeable batteries. The active electrode will be placed on the left dorsolateral prefrontal cortex (DLPFC) and the reference electrode will be placed over the controlateral supraorbital region. The direct current will be delivered through a pair of sponge electrodes with a surface of 35 cm2 (7 × 5), soaked in saline solution. This continuous stimulation will last 30 minutes, with an intensity of 1 mA. Rehabilitation programme will last for 30 minutes and includes specific exercises for prevention and management of pain. All the subjects enrolled will receive treatments for 4 weeks. During the first week the experimental group underwent tDCS daily (Monday-Friday) and rehabilitation programme 3 days per week. tDCS will be delivered before rehabilitation treatment. During the second, third and fourth week subjects will receive only rehabilitation treatment, 3 days per week.
15933882|NCT03389217|Device|Sham-tDCS + rehabilitation programme|The control group will receive the same protocol treatment but they underwent sham-tDCS during the first week of treatment. For sham condition tDCS, current was delivered for only 30 seconds and then the current was discontinued, but the tDCS apparatus was left in place for the same time as active tDCS (30 minutes)
15933883|NCT03389204|Other|PHYSICAL THERAPY|EXERCISES AND EDUCATION TO FOLLOWING AFTER DISCHARGE PHYSICAL TREATMENT
15933884|NCT03389191|Drug|Acyclovir|
15933885|NCT03389178|Diagnostic Test|Cohen Perceived Stress Scale-10 (PSS-10)|Participants with a PSS-10 score ≥19 will be categorized as stressed and entered into Phase II. For every consented subject categorized as stressed, the next screened participant matching for maternal and gestational age with a PSS-10 score < 19 will be entered into Phase II as control
15933886|NCT03389165|Device|Wearable hip assist robot|All participants climbed stairs from the first basement level to the fourth floor of the Proton Therapy Center, Samsung Medical Center, Korea with and without a wearable hip assist robot. During climbing stairs, the metabolic energy expenditure of all participants was measured using a portable cardiopulmonary metabolic system (Cosmed K4b², Rome, Italy).
15933887|NCT03389152|Device|Elastography|liver stiffness measurements by shear wave-based elastography
15933888|NCT03389139|Device|Near infrared spectroscopy (spinal anesthesia)|effect of spinal anesthesia on regional renal and cerebral oxygen saturation in newborns
15933889|NCT03389139|Device|Near infrared spectroscopy (general anesthesia)|effect of general anesthesia on regional renal and cerebral oxygen saturation in newborns
15933890|NCT03389126|Drug|Avelumab|Avelumab 10 mg/kg intravenous injection every 2 weeks until disease progression or unacceptable toxicity
15933891|NCT03389113|Device|Whole body vibration|Whole body vibration exercise is a stimulus that uses vibrations generated on a machine with oscillatory movement determined by the amplitude and frequency of the vibration.
15933892|NCT03389113|Other|Exersice|Exercise maintain a half-squat position (knee joint angle at 160 degrees) on the tilt table with an incline of 60 degrees.
15933893|NCT03389100|Drug|18F-MK6240 injection|Intravenous injection of 18F-MK-6240, up to 5 mCi (185 MBq), total of one injection per PET scan (2 injections in total with an interval of 18 to 30 months)
15933894|NCT03389087|Drug|Apatinib and Etoposide Capsule|Apatinib 250mg/qd，po, A course of treatment need 28 days. Etoposide Capsule 25mg/d，po, from day 1-day 21.
15933895|NCT03389074|Procedure|Radiofrequency catheter ablation|minimally-invasive procedure used to remove or terminate a faulty electrical pathway from sections of the hearts of those who are prone to developing cardiac arrhythmias.
15933896|NCT03389061|Drug|sofosbuvir/velpatasvir tablet|Single-dose SOF/VEL as a whole tablet in a fasted state.
15933897|NCT03389061|Drug|sofosbuvir/velpatasvir crushed|Single-dose crushed SOF/VEL in a fasted state.
15933898|NCT03389048|Device|PMD-200|The PMD-200 system is comprised of a console and designated finger probe with 4 sensors. The Sensors are Photoplethysmography (PPG) Galvanic Skin Response (GSR), Accelerometer (ACC) and Thermistor (TMP)
15933899|NCT03389048|Diagnostic Test|SLR|With the patient lying down on his/her back, the examiner lifts the patient's leg while the knee is straight.
15933900|NCT03389035|Biological|CARCIK-CD19|Allogeneic (donor-derived) Cytokine Induced Killer (CIK) cells transduced with a transposon CD19 Chimeric Antigen Receptor (CAR) gene
15933901|NCT03389022|Drug|Ketamine|Intravenous injection 0,15mg/kg (LBM) given pre-incisional in the operating room.
15933902|NCT03389022|Drug|Saline|Intravenous injection given pre-incisional in the operating room.
15933903|NCT03389009|Diagnostic Test|Ultrasound Biomicroscopy of anterior segment of the eye|5150 Vumax (Sonomed, USA) under standard illumination
15933904|NCT03388996|Diagnostic Test|microbiomes|16s RNA analysis and microculture of discharges/flushing fluid from vagina, faces and fimbria end of fallopian tube
15933905|NCT03388983|Other|6-week prehabilitation|Participants will be trained at 3 sessions/week for 6 weeks before the surgery to enhance the overall muscle strength, endurance and spinal stability. A physiotherapist/physical trainer in the participating hospital will supervise the preoperative training. The 45-minute exercise regime will include warm-up and cool-down exercises, and a cardiovascular training on a stationary bicycle, stabilization exercises with emphasis on co-contraction of abdominal and back muscles, and hip raise and hip abduction exercises. The number of repetitions and sets of each exercise will be determined based on individual's ability. Each exercise will be slightly modified based on individual progress. The exercise intensity and complexity will be increased over time.
15933906|NCT03388970|Drug|Vitamin K 1|Research group use Vitamin K1
15933907|NCT03388970|Drug|normal saline|Placebo group use normal saline
15933908|NCT03388957|Drug|Propranolol|This drug will be given before the extraction procedure
15933909|NCT03388957|Drug|Midazolam|This drug will be given before the extraction procedure
15933910|NCT03388944|Behavioral|PCT group|In this group antibiotic therapy will be stopped based on serial PCT measurements starting from admission.
15933911|NCT03388931|Radiation|Radiation Therapy|Increased radiation therapy dose
15933912|NCT03388931|Combination Product|Chemotherapy|Standard-of-care chemotherapy with treatment regimen to be determined by the treating physician
15933913|NCT03388918|Device|Telerehabilitation|Blood pressure (A&D Medical UA 767PBT), weight (A&D Medical UC-321PBT), step counters(Fitbit Zip & Charge), sleep sensor (Beddit 3), tablet (iPAD Air 2) & transmitter (Qualcomm Life, QWH-HUB-V1.0E)
15933914|NCT03388905|Device|Life Vest Wearable defibrilator|The LifeVest is a cardioverter defibrillator worn by a patient at risk for sudden cardiac arrest (SCA). It monitors the patient's heart continuously and, if the patient goes into a life-threatening arrhythmia, can deliver a shock treatment to restore the patient's heart to normal rhythm.
15933915|NCT03388892|Device|paclitaxel-coated balloon, IN. PACT(Invatec-Medtronic, Brescia, Italy)|Arteriovenous graft (AVG) dysfunction or acute thrombosis is mainly caused by neointimal hyperplasia. Although endovascular intervention, such as percutaneous transluminal angioplasty (PTA), catheter-based directed thrombolysis with urokinase, mechanical thrombectomy with percutaneous thrombolytic device or even if graft stenting, can salvage the hemodialysis access, the long-term primary and secondary patent rate don't improve due to repeated restenosis from neointimal hyperplasia. Drug eluting balloon is used in reducing neointimal hypoplasia in patients with coronary in-stent restenosis and it's also effective in restenosis of peripheral arterial diseases. It's reasonable to hypothesize that PTA with PCB at venous anastomotic stenosis of AVG could prolong the patency and reduce the acute thrombosis rate.
15933916|NCT03388892|Device|Plain Balloon|Traditional Plain Balloon was used to dilate the venous anastomotic stenosis of arteriovenous graft (AVG) as the usual intervention
15933917|NCT03388879|Device|Taylor Spatial Frame|Circular external fixator
15933918|NCT03388879|Device|Intramedullary nail|Antegrade intramedullary nail
15933919|NCT03388866|Drug|Mite extract sublingual immunotherapy (SLIT)|Administration of increasing weekly doses of extracts of mites Dermatophagoides pteronyssinus in the treatment group.
15933920|NCT03388866|Other|Placebo|Placebo group will be submitted to administration of increasing weekly doses, but with diluent of the allergenic extract (doubly distilled water solution and glycerin).
15933921|NCT03388853|Drug|Acetylcysteine/Doxofylline|Acetylcysteine/Doxofylline 1200/400 mg Effervescent Tablet once daily for four weeks.
15933922|NCT03388853|Other|Placebo|Placebo once daily for four weeks.
15933923|NCT03388840|Biological|Adipose derived stem cells suspention|application of adipose derived stem cells to the engrafted hair in hair transplantation surgery
15933924|NCT03388840|Biological|Platelet rich plasma|application of autologous platelet rich plasma to the engrafted hair in hair transplantation surgery
15933925|NCT03388827|Device|Laminaria tent|Laminaria tent was inserted for 12 hours before Hysteroscopy
15934164|NCT03387111|Drug|Capecitabine|5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine
15933927|NCT03388814|Drug|Local infiltration of bupivacaine|Patients assigned to the local infiltration with bupivacaine group will receive 30 ml of 0.25% bupivacaine with 1:200,000 epinephrine. These injections will occur at the end of the mastectomy and prior to the insertion of the tissue expander implant. The local anesthetic will be injected into the chest wall and skin flaps. Attending physicians and resident physicians will receive prior instruction regarding correct placement of the local anesthetic so that it will be consistently placed in the same locations with similar volume distribution.
15933928|NCT03388814|Drug|Pectoralis Nerve block|Patients assigned to the pectoralis block group will receive a total of 20 ml 0.25% bupivacaine (with 1:200,000 epinephrine and 1.67 mcg clonidine per ml) in the tissue plane between the serratus anterior and the pectoralis minor muscles at approximately the level of the 4th rib and 10 ml of the same solution in the tissue plane between the two pectoralis muscles at approximately the 3rd rib under ultrasound guidance on the surgical side preoperatively.
15933929|NCT03388801|Other|Spa therapy|Spa treatment was applied during a session lasting 120 to 150 minutes a day. Spa treatment lasted 3 weeks, including treatments from Monday to Friday (15 days of treatment). As a part of comprehensive spa treatment, all the patients benefited from kinesiotherapy, physical agent modalities (electrotherapy, phototherapy), massage and balneotherapy (peloid therapy, hydrotherapy with mineral waters, crenotherapy).
15933930|NCT03388788|Radiation|PET Imaging|Positron Emission Tomography (PET) imaging for research.
15933931|NCT03388788|Behavioral|Circadian Study Protocol|5-day circadian study schedule
15933932|NCT03388788|Drug|11C-Meta-Hydroxyephedrine (mHED)|11C-meta-hydroxyephedrine will be used during PET imaging to measure cardiac presynaptic norepinephrine transporter function.
15933933|NCT03388788|Drug|11C-CGP12177|Cardiac beta adrenergic receptor density will be measured via PET imaging with infusion of 11C-CGP12177.
15933934|NCT03388788|Drug|O15-water|Blood flow will be measured via PET imaging with infusion of O15-water.
15933935|NCT03388775|Other|deep venous thrombosis|Five-year prospective analysis of deep venous thrombosis performed by the RHEUNI group of five public schools in the State of São Paulo.
15933936|NCT03388762|Dietary Supplement|GlucoSupreme™ Herbal|This study will assess changes in glycemic parameters and other biomarkers over a twelve week period, with two blood draws (Baseline and 12 weeks). Additionally, an IRB-approved research associate will call each study participant at the 6-week mid-point of the study to assess compliance and collect data on any adverse events.
15933937|NCT03388762|Other|Placebo|The placebo utilized in this clinical trial will be formulated by the manufacturer to be as similar as possible to the active intervention in appearance, odor, and other key characteristics. Packaging for the control will be identical to packaging for the Active Comparator.
15933938|NCT03388749|Drug|Liposomal Annamycin|2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).
15933939|NCT03388736|Behavioral|Supplementary Medicine|A diffuser containing 120 ml water and 0.1 or 0.3 ml lavender oil (according to arm) will be set into the patients' rooms to mist at least 30 minutes before the patients arrive.
15933940|NCT03388710|Radiation|XRay|Xray to confirm the location of the endotracheal tube
15933941|NCT03388697|Diagnostic Test|Quantose IR and Quantose IGT analysis|Testing using Quantose IR and Quantose IGT: The blood draws will be timed to coincide with clinically indicated blood tests as much as possible (e.g. first visit labs, aneuploidy screening, gestational diabetes screening).
15933942|NCT03388697|Diagnostic Test|HOMA IR the standard testing for insulin resistance|Testing using HOMA IR: Investigators will be measuring fasting insulin and glucose levels (last meal more than 8hrs before testing i.e. overnight fasting) from EDTA-plasma samples. After collection, the samples will be spun and plasma obtained. Samples will be stored until testing. The investigators will be using the following computation to calculate HOMA.
15933943|NCT03388684|Procedure|Conjoined twin separation surgery|This study included 4 case reports on conjoined twins (CT), 2 male and three female patients; 3 of them were parasitic and one was conjoined. We operated upon 2 parasitic and one conjoined. The 1st case died preoperatively.
15933944|NCT03388671|Procedure|TAB Block|patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided TAB Block
15933945|NCT03388671|Procedure|Psoas Block|patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided Psoas Block
15933946|NCT03388671|Drug|Bupivacaine|patients will recieve 0.3ml/kg bupivacaine 0.25% on each side for laparoscopically guided Psoas Block or TAB block
15933947|NCT03388645|Biological|10^6.3 PFU of RSV A2|Each adult volunteer will receive a single intranasal inoculation of 10^6.3 PFU of RSV A2 administered with a nasal atomizer with subsequent sampling of nasal fluids and blood draws.
15933948|NCT03388645|Biological|10^7 PFU of RSV A2|Each adult volunteer will receive a single intranasal inoculation of 10^7 PFU of RSV A2 administered with a nasal atomizer with subsequent sampling of nasal fluids and blood draws.
15933954|NCT03388593|Drug|rhNRG-1|10 hours per day i.v drip for the first 10 days (0.6ug/kg/day), followed by weekly 10 minutes i.v bolus (0.8ug/kg/day), from the 3rd week for 23 weeks
15933955|NCT03388593|Drug|Placebo|10 hours per day i.v drip for the first 10 days (0ug/kg/day), followed by weekly 10 minutes i.v bolus (0ug/kg/day), from the 3rd week for 23 weeks
15933956|NCT03388580|Procedure|bronchoalveolar lavage (BAL)|clinically indicated, elective BAL
15933957|NCT03388567|Other|Staff pharmacy whith intervention|Pharmacists who will receive continuous education through technology and communication tools, as well as accompaniment and advice from a pharmaceutical chemist
15933958|NCT03388554|Device|tDCS|
15933959|NCT03388541|Drug|Dexmedetomidine|Dexmedetomidine will be started at 5mL/h while the patient is still in the operating room. The patient will be transferred to the intensive care unit with a sedative regimen based on propofol.
15933960|NCT03388541|Drug|Placebo|A continuous infusion of NaCL 0.9% will be started at 5mL/h while the patient is still in the operating room. The patient will be transferred to the intensive care unit with a sedative regimen based on propofol.
15933961|NCT03388528|Dietary Supplement|Low Residue Diet Intervention|All patients will be provided with a LRD plan (< 10g fibre per day) for 12 weeks between visits 2 and 3. They will also be supplemented with multivitamin and mineral tablet or liquid (Forceval) to meet nutrient requirements (prescribed as standard care). The dietitian will provide written and oral information about the LRD and weekly telephone calls to assess patient's progress on the diet.
15933962|NCT03388515|Biological|SSS11|IV infusion for 60 min.
15933963|NCT03388515|Other|placebo|IV infusion for 60 min.
15933964|NCT03388502|Other|Automated Text Messaging (SMS) Bot (intervention group)|Patients will be enrolled in an 'Automated Text Messaging (SMS) Bot (intervention group)' which is a computer program that sends patients timely reminders, instructions, and videos to help them prepare and recover from surgery.
15933965|NCT03388502|Other|Routine perioperative education & teaching (control group)|Patients will receive the 'Routine perioperative education & teaching (control group)' and will not be enrolled in the physician-specific SMS bot.
15933966|NCT03388489|Behavioral|Mind-Body Walking|walking, breathing, and mindfulness
15933967|NCT03388476|Diagnostic Test|Capnography|Measuring of the exhaled air, especially endtidal co2, through capnography.
15933968|NCT03388463|Drug|Omeprazole|Omeprazole 80 mg continues infusion
15933969|NCT03388463|Drug|Placebo group|Omeprazole 40 mg single daily dose.
15933970|NCT03388450|Drug|Omega 3|Enteral 1000 mg omega 3 fatty acid.
15933971|NCT03388450|Drug|Placebo|Enteral nutrition without omega 3 fatty acid.
15933972|NCT03388437|Device|NI-NAVA|"Enrolled infants will receive Surfactant and loading dose of Caffeine citrate prior to extubation. The criteria for extubation will be as per attending decision.
~The device is used Servo-I ventilator (MAQUET). FiO 2 % is adjusted to maintain oxygen saturation between 90-94% on pulse oximetry. The flow rate is 8-10 L/min. NAVA electrodes will be inserted within nasogastric catheter & positioned at the level of diaphragm.Vital signs and ventilatory parameters are monitored hourly. Blood gases will be measured before and one hour after extubation"
15933973|NCT03388437|Device|NIPPV|"Enrolled infants will receive Surfactant and loading dose of Caffeine citrate prior to extubation. The criteria for extubation will be as per attending decision.
~The device is used Servo-I ventilator (MAQUET). FiO 2 % is adjusted to maintain oxygen saturation between 90-94% on pulse oximetry. The flow rate is 8-10 L/min. NAVA electrodes will be inserted within nasogastric catheter & positioned at the level of diaphragm.Vital signs and ventilatory parameters are monitored hourly. Blood gases will be measured before and one hour after extubation"
15933974|NCT03388424|Diagnostic Test|quantification of microbiota|For each group a sample of biological sample will be take and will be analyzed using the n-counter flex platform in order to quantify disbiosis
15933975|NCT03388411|Diagnostic Test|Gut microbiome profiling|Gut microbial profiling will be done with next-generation sequencing targeting bacterial 16s rRNA genes.
15933976|NCT03388385|Drug|Sodium Chloride 0.9% Intravenous Solution|Physiologic saline infusion will be infused in day 1.
15933977|NCT03388385|Drug|Ferinject|Ferric carboxymaltose will be infused in day 2.
15933978|NCT03388372|Biological|Nimotuzumab|Nimotuzumab, 200 mg as 1-hour intravenous infusion once weekly, from first week to last week of RT for a total of 6 times.
15933979|NCT03388372|Drug|Temozolomide|Temozolomide, 75 mg/m2/d was administered orally from the first to the last day of RT. After 4-week break, individualized adjuvant TMZ was given based on MGMT status. The standard 5-day schedule every 4 weeks for six cycles was given for patients with negative MGMT expression. Dose was 150mg/m2 for the first cycle and 200 mg/m2 from the second cycle. The 7-day on/7-day off schedule every 2 weeks for 12 cycles was given for patients with positive MGMT expression. The dose was 100 mg/m2 for the first two cycles and 150 mg/m2 starting from the third cycle.
15933980|NCT03388372|Radiation|Radiotherapy|Fractionated 3D conformal RT was given at 2.0Gy per fraction, 5 daily fractions per week for 6 weeks.
15933981|NCT03388359|Procedure|Bronchial challenge with allergen|Bronchial challenge is performed with D. pteronyssinus allergen. Measurements of differences in eosinophils activity after allergen challenge.
15933982|NCT03388359|Other|Co-culture formation|Eosinophil and linear bronchial smooth muscle cell or pulmonary fibroblast co-culture formation. Bronchial smooth muscle cell and pulmonary fibroblast proliferation, migration, contractillity, differentiation, eosinophil adhesion to the bronchial smooth muscle cells or pulmonary fibroblast.
15933983|NCT03388359|Other|Inhibition of Wnt and Smad signaling pathways|Wnt and Smad signaling pathways inhibitors effect on development of airway remodelling processes (extracellular matrix production, bronchial smooth muscle cell and pulmonary fibroblast proliferation, contractillity, differentiation, migration).
15933984|NCT03388359|Other|Extracellular matrix turnover and deposition assessment|Eosinophils effect on extracellular matrix proteins (collagen, fibronectin, elastin, versican, decorin, laminin, etc.) and matrix metalloproteinasis (MMP-2,9,12,etc.) production by pulmonary fibroblasts.
15933985|NCT03388359|Biological|Dermatophagoides pteronyssinus allergen|Dermatophagoides pteronyssinus allergen is required to perform allergen bronchial challenge test.
15933986|NCT03388359|Device|Dosimeter ProvoX (Ganshorn)|Device for allergen bronchial challenge test.
15933987|NCT03388359|Biological|Eosinophils|Eosinophils are isolated from peripheral blood
15934165|NCT03387111|Drug|Cetuximab|Cetuximab is an epidermal growth factor receptor (EGFR) antagonist.
15933988|NCT03388359|Biological|Airway smooth muscle cells|Airway smooth muscle cells from healthy subjects (support from the University of Groningen)
15933989|NCT03388359|Biological|Fibroblasts|Normal human fibroblast cell lines (commercial fibroblast lines)
15933990|NCT03388346|Drug|Ga-68 PSMA-HBED-CC PET|Ga-68 PSMA-HBED-CC is an investigational PET drug (radionuclide), that binds to the prostate specific receptors. The dose will be about 5mCi (range 3-7 mCi) and administered intravenously.
15933991|NCT03388333|Procedure|Catheter Ablation|
15933992|NCT03388320|Device|A-CHESS|Use of smartphone application: Addiction Comprehensive Health Enhancement Support System (A-CHESS)
15933993|NCT03388307|Procedure|unilateral laminotomy|minimally invasive technique
15933994|NCT03388307|Procedure|decompressive laminectomy|classic surgery
15933996|NCT03388281|Other|No intervention, retrospective analysis only.|No intervention, retrospective analysis only.
15933997|NCT03388268|Drug|Oral Vancomycin|Oral vancomycin 125mg 4 times per day
15933998|NCT03388268|Drug|Placebo|Sugar liquid manufactured to mimic oral vancomycin 125mg
15933999|NCT03388268|Device|Toxin enzyme immunoassay|EIA assay: Wampole/Tech Lab Tox A/B II
15934000|NCT03388268|Device|Nuceleic acid amplification test|NAAT: Xpert C. difficile, Cepheid
15934001|NCT03388255|Drug|Polydeoxyribonucleotides|"Polydeoxyribonucleotide 5.625 mg/3 ml for parenteral use i.m.
~The study period consists of the following phases:
~Treatment period: 3 months (daily i.m. treatment with PLACENTEX ® Polydeoxyribonucleotide 5.625 mg/3 ml for parenteral use, one vial per day for intra-muscular administration).
~Follow up period: 3 months after end of active treatment, without study medication."
15934002|NCT03388242|Other|No intervention|Patients will be recruited into the study in their initial visit before patients are on any drug treatments for their AD or MCI. The study does not include use of any interventions.
15934003|NCT03388229|Behavioral|not an intervention|it was observation not intervention
15934004|NCT03388216|Biological|Drug: INM004 Dose 1|Stage I- Cohort I: (2mg/kg) administered at a single dose. The ratio is 3:1 (investigational product:placebo) -
15934005|NCT03388216|Biological|Drug: INM004 Dose 2|Stage I- Cohort II: Dose 2 (4mg/kg) administered at a single dose. The ratio is 3:1 (investigational product:placebo)
15934006|NCT03388216|Biological|Drug: INM004- Repeated dose|Stage II: Either 3 doses of 2 mg/kg or 4 mg/kg will be administered every 24 hs. The ratio is 5:1 (investigational product : placebo).
15934007|NCT03388216|Other|Placebo|A placebo infusion will be administered at the same infusion rate as the Drug arm
15934008|NCT03388203|Diagnostic Test|25(OH)D measurement, PTH measurement|25(OH)D analyses by LC-MS/MS were performed as part of our routine clinical work with a commercial kit from Recipe (Munich, Germany) ; PTH was measured in lithium-heparin plasma using the PTH STAT assay from Roche Diagnostics (Mannheim, Germany) on a Cobas 8000 auto-analyzer.
15934009|NCT03388190|Drug|Nivolumab|"FLOX: Intravenous oxaliplatin 85 mg/m2 on day 1; bolus 5-fluorouracil 500 mg/m2 and bolus Leucovorin on days 1 and 2; IV administration every 2 weeks.
~Nivolumab: 240 mg flat dose; IV administration every 2 weeks."
15934010|NCT03388190|Drug|FLOX|FLOX: Intravenous oxaliplatin 85 mg/m2 on day 1; bolus 5-fluorouracil 500 mg/m2 and bolus Leucovorin on days 1 and 2; IV administration every 2 weeks.
15934011|NCT03388177|Behavioral|Yoga-based therapy|
15934012|NCT03388177|Other|Treatment as usual|
15934013|NCT03388164|Drug|Escitalopram + RT2CK17|Participants randomized to active or placebo condition will be prescribed medication over the course of 8 weeks, with in-person follow-up visits at weeks 0, 2, 4 and 8, with follow-up phone calls on weeks 1, 3 and 6.
15934014|NCT03388164|Drug|Escitalopram + Placebo|Participants randomized to active or placebo condition will be prescribed medication over the course of 8 weeks, with in-person follow-up visits at weeks 0, 2, 4 and 8, with follow-up phone calls on weeks 1, 3 and 6.
15934015|NCT03388151|Drug|Midazolam|Midazolam 3 mg i.v added to fentanyl 0.5 ug/kg till reaching satisfactory level of sedation
15934016|NCT03388151|Drug|Propofol|Propofol 1 mg/kg i.v added to fentanyl 0.5 ug/kg i.v till reaching satisfactory level of sedation
15934017|NCT03388138|Combination Product|etafilcon A with ketotifen|Etafilcon A with ketotifen
15934018|NCT03388138|Device|1-Day ACUVUE|1-Day ACUVUE
15934019|NCT03388125|Drug|Injection Sclerotherapy|5% ethanolamine oleate group
15934020|NCT03388125|Drug|N-butyl-2-cyanoacrylate|N-butyl-2-cyanoacrylate injection group
15934021|NCT03388112|Dietary Supplement|Probiotics|the patients in this arm will receive probiotics blend of Bifidobacterium longum, Lactobacillus acidophilus, Enterococcus faecalis with does of 1.5*10^7CFU for 2 weeks
15934022|NCT03388086|Drug|Injection of Onabotulinum toxin|multiple injections of Onabotulinum toxin into the detrusor muscle
15934023|NCT03388073|Other|Berry extract I|Seabuckthorn berry proanthocyanidin extract 250 mg single dose
15934024|NCT03388073|Other|Berry Extract II|Seabuckthorn berry proanthocyanidin extract 500 mg single dose
15934025|NCT03388073|Other|Berry extract blend|Seabuckthorn berry blend with other berry-based antioxidants
15934026|NCT03388073|Other|Placebo|Placebo
15934027|NCT03388060|Procedure|Ultrasound guided SWL|Ultrasound guided SWL for radiolucent renal stone
15934028|NCT03388060|Procedure|Dissolution therapy|Alkalinization dissolution therapy for radiolucent renal stone
15934029|NCT03388060|Procedure|Combined ultrasound guided SWL and dissolution therapy|Combined ultrasound guided SWL and alkalinization dissolution therapy for radiolucent renal stone
15934030|NCT03388047|Device|Endoscopy with Polyscope (Polydiagnost TM) coupled with Multi-Spectral Imaging light-source|During surveillance endoscopy procedure, the endoscopist will insert the multispectral endoscopy probe through the working channel and use this to inspect the Barrett's oesophagus segment and any visible lesions
15934031|NCT03388034|Procedure|Nasopharyngeal sampling|A nasopharyngeal sample collected from each nostril by swabbing
15934032|NCT03388034|Procedure|Blood Sampling|Blood sample by the tip of a finger (fingerprick)
15934166|NCT03387111|Drug|Cisplatin|cis-diamminedichloroplatinum(II)
15968878|NCT03120520|Drug|Matching placebo|
15934033|NCT03388021|Procedure|completion angiography followed by endovascular treatment of residual or underlying lesions|completion angiography followed by endovascular treatment as thromboembolectomy under fluoroscopic guidance using Fogarty over the wire, angioplasty, stenting, or Intraarterial thrombolysis to treat residual or underlying lesions
15934034|NCT03388008|Drug|Belatacept|Belatacept will be dosed at 10 mg/kg of actual body weight on days 0, 7, 14, 28, 56, and 84 then at 5 mg/kg on day 112 and every 28 days through day 364 (i.e., on days 140, 168, 196, 224, 252, 280, 308, 336, and 364)
15934035|NCT03388008|Drug|Tacrolimus|Tacrolimus will be dosed enterally or sublingually within 48 hours of transplantation and the dose will be adjusted to target a trough blood level of 8-15 ng/ml
15934036|NCT03388008|Drug|ATG|Anti-thymocyte globulin will be dosed intravenously at 3 mg/kg divided into 3 daily doses starting on day 0 after transplantation
15934037|NCT03388008|Drug|Mycophenolate Mofetil|Mycophenolate mofetil will be dosed at 1000 mg twice daily (or if the enteric coated formulation is used, this will be dosed at 720 mg twice daily. In the standard of care arm, mycophenolate mofetil will be initiated on day 0 after transplantation, whereas in the belatacept-based immunosuppression arm, mycophenolate mofetil will be initiated on day 90 after transplantation
15934038|NCT03388008|Drug|Methylprednisolone|Methylprednisolone 500 mg will be given intravenously before perfusion of the allograft during the transplant procedure, then methylprednisolone 0.5 mg/kg will be given intravenously twice daily for 6 total doses
15934039|NCT03388008|Drug|Prednisone|Prednisone will be dosed at 0.5 mg/kg orally daily through day 14, then 0.2 mg/kg orally daily through day 30, then 0.1 mg/kg daily through day 180, then 5 mg daily through day 365
15934040|NCT03387995|Device|LVIS stent|The group has 80 patients.
15934041|NCT03387995|Device|Solitire stent|The group has 80 patients.
15934042|NCT03387995|Device|Enterprise stent|The group has 80 patients.
15934043|NCT03387995|Device|Neuroform stent|The group has 80 patients.
15934044|NCT03387995|Device|Pipeline stent|The group has 80 patients.
15934045|NCT03387969|Procedure|CSF sample|"for all patient CSF sample obtained for analysis , culture sensitvity and CSF-CRP.
~also blood samples will be collected and analyzed for serum procalcitonin"
15934046|NCT03387956|Drug|Intrathecal atropine|100ug intrathecal atropine will be injected with spinal anesthesia
15934047|NCT03387956|Drug|dexamethasone|intravenous 8 mg dexamethasone (2ml).
15934048|NCT03387943|Drug|PLD|intravenous infusion of liposomal doxorubicin 35 mg/m2, d1,once every 21days, for 6 cycles.
15934049|NCT03387943|Drug|Cisplatin|cisplatin 75 mg/m2, drip, total dose should be carried out on d1-3; once every 21days, for 6 cycles.
15934050|NCT03387917|Drug|TLD-1|TLD-1 is a new liposomal formulation of the anthracycline doxorubicin.
15934051|NCT03387917|Drug|Caelyx|Caelyx is a liposomal formulation of the anthracycline doxorubicin
15934052|NCT03387904|Drug|Anlotinib Plus Irinotecan|Anlotinib QD po.and Irinotecan Day 1,8 ivgtt.
15934053|NCT03387904|Drug|Irinotecan|Irinotecan Day 1,8 ivgtt
15934054|NCT03387891|Device|Cortrium C3 device|Paired measurements of data from C3 device with golden standard methods or equipment
15934055|NCT03387878|Device|Intermittent Catheter|Intermittent urinary catheter for bladder drainage
15934056|NCT03387865|Procedure|tissue biopsies|additional biopsies will be performed during a diagnostic or therapeutic procedure, in order to sample tumor tissue and healthy tissue.
15934057|NCT03387865|Procedure|blood sampling|additional blood samples will be collected during a SOC sampling procedure (2 EDTA 7.5 ml tubes, 2 SST 7.5 ml tubes and 2 citrate 5 ml tubes)
15934058|NCT03387865|Genetic|DNA banking|constitutional and somatic genetic alterations will be analysed for subjects who consent, from either tumor or healthy tissue, or whole blood buffy coat after centrifugation
15934059|NCT03387852|Drug|SAR440340|Pharmaceutical form: Solution for Injection Route of administration: SC
15934060|NCT03387852|Drug|Dupilumab|Pharmaceutical form: Solution for Injection Route of administration: SC
15934061|NCT03387852|Drug|Fluticasone or Fluticasone/salmeterol combination|Pharmaceutical form: Aerosol, dry powder Route of administration: Inhaled
15934062|NCT03387852|Drug|Placebo for SAR440340|Pharmaceutical form: Solution for Injection Route of administration: SC
15934063|NCT03387852|Drug|Placebo for dupilumab|Pharmaceutical form: Solution for Injection Route of administration: SC
15934064|NCT03387839|Other|Stress X-Ray|Antero-posterior stability of the knee measured with stress x-rays using the TELOS Stress device in 45° and 90° flexion
15934065|NCT03387826|Drug|Ticagrelor 60 mg|Ticagrelor 60 mg twice daily
15934066|NCT03387826|Drug|Prasugrel 5mg|Prasugrel 5 mg once daily
15934067|NCT03387813|Device|CardioMEMS™ HF System|The CardioMEMS™ HF System is comprised of a lead-less, battery-less pressure sensor permanently implanted in the PA, which remotely transmits PA pressure measurements from the patient's home to a secure website. Healthcare professionals are able to access these measurements and associated waveforms to remotely guide individualization of medical management for their patients with chronic HF.
15934068|NCT03387800|Behavioral|Basic health education messages|Messages containing basic health education materials, including perceived severity of smoking, perceived benefit of smoking cessation and tips on resisting situational temptations will be sent to the participants of both arms through WeChat after randomization takes place.
15934069|NCT03387800|Behavioral|WeChat interactive peer support group|Participants will be grouped together by the researcher to form closed online peer support groups (with group names they choose). Activities on the WeChat groups serve two functions: i) It enhances social support among peer members toward smoking cessation. ii) The online support group also enhances the participants' positive affect.
15934070|NCT03387787|Device|GlucoTab|"The GlucoTab® system is a computerized decision support system built of an android based front-end user interface and a backend server including the REACTION algorithm. GlucoTab® is able to process blood glucose data and physiological confounders of glycaemia. Subsequently, GlucoTab® provides patient-specific basal, bolus, and correction insulin doses together with visualization and documentation of relevant data.
~Insulin doses of recruited patients will be calculated by the GlucoTab System for at least 48 hours and a maximum duration of 21 days."
15934071|NCT03387787|Drug|Insulin Degludec|During the study, patients will be treated with basal Insulin degludec
15934167|NCT03387111|Drug|Cyclophosphamide|2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
15934072|NCT03387774|Drug|Cisplatin|"Patients in both arms received concurrent cisplatin chemotherapy:
~100 mg/m² cisplatin given intravenously every 3 weeks on days 1, 22 concurrently with radiotherapy."
15934073|NCT03387774|Radiation|Intensity Modulated Radiation Therapy|"Patients in both arms received Intensity Modulated Radiation Therapy:
~All target volumes were outlined slice by slice on the axial contrast-enhanced CT with MR fusion images in the treatment planning system. The target volumes were defined in accordance with the International Commission on Radiation Units and Measurements Reports 50 and 62. The prescribed dose was 68-72 Gy to PTVnx (Planning target volume of the primary tumor), 64-68 Gy to GTVnd (Gross tumor volume of the cervical lymph node), 60- 64Gy to PTVnd and PTV1 (Planning target volume 1), and 54-58 Gy to PTV2 (Planning target volume 2) in 30-32 fractions. The details of dose limits for organs at risk were based on the study 0225 from The Radiation Therapy Oncology Group (RTOG 0225)."
15934074|NCT03387774|Drug|Ulinastatin|"Patients in the experimental group were received ulinastatin:
~Ulinastatin (UTI): ulinastatin was intravenous drip at a dose of one hundred thousand units added to 100 ml of 0.9% normal saline every time, 3 times every radiation day, and until the end of radiotherapy."
15934075|NCT03387761|Drug|Ipilimumab|"For Cohort 1:
~Day 1: Ipilimumab 3 mg/kg
~Days 22: Ipilimumab 3 mg/kg
~For Cohort 2a:
~Day 1: Ipilimumab 3 mg/kg
~Days 22: Ipilimumab 3 mg/kg
~For Cohort 2b:
~Day 1: Ipilimumab 1 mg/kg
~Days 22: Ipilimumab 1 mg/kg"
15934076|NCT03387761|Drug|Nivolumab|"For Cohort 1:
~Day 22: Nivolumab 1 mg/kg
~Day 43: Nivolumab 3 mg/kg
~For Cohort 2a:
~Days 1 and 22: Nivolumab 1 mg/kg
~Day 43: Nivolumab 3 mg/kg
~For Cohort 2b:
~- Days 1, 22 and 43: Nivolumab 3 mg/kg"
15934077|NCT03387748|Behavioral|Gesture elicitation|"Participants are required to gesture with their hands (and not speaking) one by one 30 pictures from the Boston Naming Task which appear on a laptop screen.
~Participants retell a cartoon to the researcher
~The researcher initiates a 10-min spontaneous conversation.
~These three tasks are video-recorded."
15934078|NCT03387735|Other|Treatment as usual (TAU) + Internet|Patients in this group will receive TAU+internet and links to helpful websites.
15934079|NCT03387735|Behavioral|TAU + ElderTree|"For the patient, ElderTree provides tools, motivation, and social support to help them manage their specific set of chronic conditions and communicate with peers and their primary care physician.
~For the clinic, ElderTree has a Clinician Report (CR), a visual dashboard of health-tracking data that can be customized based on the needs of the clinic. The CR provides alerts to the clinician when a patient passes a certain threshold. The dashboard is intended to help clinicians prepare for patient office visits."
15934080|NCT03387709|Behavioral|Pistachio-enriched diet|Composition of prescribed diets will be based on individual preferences, with the goal of consuming 1.5 oz of pistachios per day and increased energy expenditure. During the 4-month intervention, study subjects will participate in individualized counseling and group sessions, with in-person, telephone, email and text message contacts to provide support and behavioral guidance and strategies. Pistachios will be provided to participants. The overall content of the intervention consists of key elements of cognitive-behavioral therapy for obesity. The physical activity component emphasizes planned aerobic exercise, increased physical activity in the lifestyle, and strength training.
15934081|NCT03387709|Behavioral|General dietary guidance diet|During the 4-month group intervention, study subjects will participate group sessions, receive telephone, email and/or text message contacts to provide support and behavioral guidance and strategies. The overall content of the intervention consists of key elements of cognitive-behavioral therapy for obesity. The physical activity component emphasizes planned aerobic exercise, increased physical activity in the lifestyle, and strength training.
15934082|NCT03387683|Drug|dapagliflozin|dapagliflozin 10mg
15934083|NCT03387683|Drug|placebo|placebo to match dapagliflozin
15934084|NCT03387670|Drug|Simvastatin|"One (1 = 40mg) simvastatin tablet once daily at night for 1 month
~Two (2 = 80mg) simvastatin tablets once daily at night, for the next 35 months"
15934085|NCT03387670|Drug|Placebo|"One (1) placebo tablet once daily at night for 1 month
~Two (2) placebo tablets once daily at night, for the next 35 months"
15934086|NCT03387657|Drug|Sotagliflozin (SAR439954)|"Pharmaceutical form: Tablet
~Route of administration: Oral"
15934087|NCT03387657|Drug|Hydrochlorothiazide|"Pharmaceutical form: Tablet
~Route of administration: Oral"
15934088|NCT03387644|Drug|Pregabalin (PG)|Pregabalin 150 mg one hour before the procedure as premedication.
15934089|NCT03387644|Drug|Control placebo (C)|Placebo tablets one hour before the procedure as premedication.
15934090|NCT03387631|Drug|Artemether-Lumefantrine|
15934091|NCT03387618|Diagnostic Test|Digital PET/CT imaging|Next generation PET/CT imaging
15934092|NCT03387605|Drug|Ivabradine|ivabradine or placebo given orally 2 times daily for 72 hours
15934093|NCT03387605|Drug|Placebo|matching placebo given 2 times daily for 72 hours
15934094|NCT03387592|Drug|CPT-11|180 mg/m2
15934095|NCT03387592|Drug|Calcio levofolinate|200 mg/m2
15934096|NCT03387592|Drug|5-Fluorouracil|400 mg/m2 + 2400 mg/m2
15934097|NCT03387592|Drug|Capecitabine|1500 mg/m2
15934098|NCT03387592|Drug|Temozolomide|200 mg/m2
15934099|NCT03387579|Drug|Lipid Emulsions, Intravenous|Intravenous lipid containing soy, MCT, olive, and fish oils
15934100|NCT03387579|Drug|Intralipid, 20% Intravenous Emulsion|Intravenous lipid emulsion of 20% soy oil
15934101|NCT03387566|Drug|HB002.1M|HB002.1M is a Vascular Endothelial Growth Factor Receptor Decoy.
15934102|NCT03387553|Biological|Dendritic Cell Vaccine (DC1)|"Study Vaccine:
~Lead In Phase - Weekly as outlined in each treatment Arm.
~Expansion Phase - At the optimal schedule determined at the end of the Lead In Phase.
~Pre-surgery - Booster Vaccine at week 25 prior to receiving surgery.
~Post-surgery - Participants will receive a series of 3 booster intranodal study vaccines given once every 6 months."
15934103|NCT03387553|Drug|Neoadjuvant Chemotherapy|Upon completion of the 3 week series of vaccinations participants will then undergo neoadjuvant chemotherapy treatment with the TCH-P Taxotere (docetaxel), Carboplatin, Herceptin (trastuzumab), Perjeta (pertuzumab) standard of care neoadjuvant chemotherapy regimen given intravenously once every 3 weeks for up to 6 cycles. The treating physician will have the discretion to delay, modify, or shorten the neoadjuvant chemotherapy as per routine practice guidelines and physician discretion.
15934104|NCT03387553|Procedure|Curative Surgery|Planned definitive curative surgery at 26 to 28 weeks.
15934168|NCT03387111|Drug|Fluorouracil|5-fluoro-2,4 (1H,3H)-pyrimidinedione
15934527|NCT03384576|Other|No music|No music played in emergency waiting room
15934105|NCT03387540|Drug|ICI|Immune checkpoint inhibitor targeting either PD-1, PD-L1 or CTLA-4, and included in the following list (ATC classification): Ipilimumab (L01XC11), Nivolumab (L01XC17), Pembrolizumab (L01XC18), Durvalumab (L01XC28), Avelumab (L01XC31), Atezolizumab (L01XC32).
15934106|NCT03387527|Behavioral|Prostate cancer decision aid|Patients will undergo standardized counseling and individualized counseling with the screening decision aid. The screening decision aid is a computer program that provides individual patients estimates of their risks of prostate cancer diagnosis, prostate cancer related death, or death from any cause
15934107|NCT03387514|Drug|PSMA-based 18F-DCFPyL PET tracer for PET/CT exams|"18F-DCFPyL whole body PET/CT scan administered at the following timepoints:
~PET1 - Prior to scheduled nephrectomy
~PET2 - to establish a new baseline PET before systemic therapy
~PET2A - Post-surgery and prior to start of standard of care systemic therapy
~PET2B - 12-16 weeks from start of first line systemic therapy (immune-based or anti-angiogenic)
~PET3 - If first line systemic therapy did not include anti-angiogenesis therapy and new systemic therapy does include anti-angiogenesis therapy
~PET3A - Prior to start of additional anti-angiogenesis therapy
~PET3B - 12-16 weeks from the start of additional anti-angiogenesis therapy
~PET4 - obtained at clinical progression or 2 years following initial systemic therapy"
15934108|NCT03387501|Drug|Plasma rich in growth factors (PRGF-Endoret)|Intrauterine administration of PRGF
15934109|NCT03387488|Device|StingrayTM, Medtronic®|Video- assisted pericardioscopic surgery for implanting epimyocardial pacemaker lead model 09090, Medtronic®
15934110|NCT03387475|Drug|Deferasirox|iron chelation
15934113|NCT03387449|Device|Bimanual Arm Training|Device-based bimanual-to-unimanual training will be provided with the Bimanual Arm Trainer (BAT, Mirrored Motion Works, NC). The device provides bimanual-to-unimanual training of simultaneous shoulder external rotation and elbow extension, and independent training of pronation-supination and grasp and release of each hand. Range of motion and speed are recorded during training and feedback and motivation are provided through age-appropriate gaming modules.
15934114|NCT03387436|Behavioral|Sham-Intervention|The sham intervention does not target the specific topics of the study intervention group (i.e. no special focus an ACP or end of life communication). Supportive therapy uses common factors of psychotherapy such as elicitation of affect, reflective listening, and feeling understood, but provides no explicit theoretical formulation to the patient. The therapist tries to elicit and validate the patients' affect for instance on the realization that there is no curative treatment option. Supportive therapy has been used as an unspecific control condition in several studies (Cohen et al. 2011; Markowitz et al. 1998). Patients of the sham intervention will be informed about the benefits of advance directives in general.
15934115|NCT03387436|Behavioral|Study-Intervention|"The design of the study-intervention was influenced by dignity therapy (Chochinov et al. 2005), the End-of-life-Review (Ando et al. 2010) and barriers concerning participation of ACP identified by research (Bollig et al. 2017; Gjerberg et al. 2015). It is the goal of the study-intervention to enhance communication about death related topics of patients and their relatives/caregivers.
~Our study intervention extends over six therapeutic sessions. The length of each session will be adjusted to the patients physical condition, it should not exceed 45 minutes in total.
~In the first four sessions, patients and relatives will be informed about the relevance of ACP. Potential barriers for an efficient patient-caregiver communication and ACP are discussed. The intervention focuses on encouraging end-of-life communication and on jointly modifying barriers to EOL communication.
~The fifth and sixth session focus on ACP based on the standardised concept of beizeiten begleiten."
15934116|NCT03387423|Drug|Tofacitinib|Patients who are started on Tofacitinib treatment according to the drug label
15934117|NCT03387410|Drug|Intravenous IRDye 800BK|Fluorescence of the ureter using IRDye 800BK
15934118|NCT03387384|Other|Non-interventional study|Non-interventional study
15934119|NCT03387371|Device|Ultrasonics|ultrasonic scalers
15934120|NCT03387371|Device|Gracey Curettes|Spesific gracey curettes
15934121|NCT03387371|Device|Er:YAG Laser|2940 nm wavelenght Er:YAG laser
15934122|NCT03387358|Device|Nasal bridle securement device for small bore feeding tubes|A Nasal bridle securement device is an alternative method to securing small bore feeding tubes which are most commonly secured with adhesive tape to the nose. A nasal bridle securement device instead secures the feeding tube to a cloth ribbon that is inserted in one nostril, over then nasal bridle and out the other nostril.
15934123|NCT03387345|Other|100% steel cut barley|25 g of available carbohydrate was delivered to participants via steel cut Sustagrain barley (Ardent Mills, LLC).
15934124|NCT03387345|Other|100% barley flakes|25 g of available carbohydrate was delivered to participants via Sustagrain barley flakes (Ardent Mills, LLC).
15934125|NCT03387345|Other|50/50 rice-barley mix|25 g of available carbohydrate was delivered to participants via a 50/50 mixture (by weight) of Goya medium grain white rice and steel cut Sustagrain barley (Ardent Mills, LLC).
15934126|NCT03387345|Other|80/20 rice-barley mix|25 g of available carbohydrate was delivered to participants via a 80/20 mixture (by weight) of Goya medium grain white rice and steel cut Sustagrain barley (Ardent Mills, LLC).
15934127|NCT03387345|Other|100% rice|25 g of available carbohydrate was delivered to participants via Goya medium grain white rice
15934128|NCT03387345|Other|white bread|25 g of available carbohydrate was delivered to participants via Sara Lee Classic White Bread (Bimbo Bakeries USA, Inc.)
15934129|NCT03387332|Drug|APG-1252|Multiple dose cohorts, 30 minute IV infusion, twice weekly for 3 weeks of a cycle with 28 days.
15934130|NCT03387319|Behavioral|Racialized Stressful Event Recall|"Participants will undergo a moderate psychological stress adapted from the Trier Social Stress Test (TSST) where they will be asked to recall a stressful, real-life, race-related event.
~After instructions are provided, participants will be given two minutes to prepare their statement, and three minutes to deliver their statement. There will be an 'audience' present at each participant's speaking task which will include two observers who are of same race as the participant (African American), to heighten stress responses."
15934169|NCT03387111|Drug|Leucovorin|L-Glutamic acid, N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-, calcium salt
15934221|NCT03386968|Behavioral|Usual care physical therapy|Children will attend their usual care physical therapy appointments at Blythedale.
15934131|NCT03387319|Behavioral|Non-Racialized Stressful Event Recall|"Participants will undergo a moderate psychological stress adapted from the Trier Social Stress Test (TSST) where they will be asked to recall a stressful, real-life, event unrelated to race.
~After instructions are provided, participants will be given two minutes to prepare their statement, and three minutes to deliver their statement. There will be an 'audience' present at each participant's speaking task which will include two observers who are of same race as the participant (African American), to heighten stress responses."
15934132|NCT03387293|Other|LGI-LII Breakfast|This test meal with low GI and low FII amounts were served as a breakfast after 12-hours fasting and participants were asked to consume the meal in full, within 15 min.
15934133|NCT03387293|Other|LGI-HII Breakfast|In crossover design, this test meal with low GI and high FII amounts were served as a breakfast to compare the LGI-LII Breakfast.
15934134|NCT03387267|Device|Dysphagia Detection System|The Nestle Health Sciences (NHSc) Dysphagia Detection System (DDS) is a portable, non-invasive device designed for use at the bedside. The investigational DDS has 3 basic components: Sensor Unit (suspended on a necklace), Sensor Fixation and a personal computer (PC) for collecting data. The Sensor Unit consists of a dual-axis accelerometer in a plastic housing that is attached to the front of a patient's neck just below the thyroid cartilage by the single-use, disposable fixation unit. The Sensor Unit is connected via a cable to an A/D converter which then connects via cable to the PC. The PC collects the examination data, which is then sent to dedicated application software (installed at the CRO), which interprets the acceleration data and displays the examination result.
15934135|NCT03387254|Device|VR + active brain stimulation|Active Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)
15934136|NCT03387254|Device|VR + sham brain stimulation|Sham Brain stimulation (tDCS) is applied during exposition to virtual reality (20 minutes)
15934137|NCT03387241|Drug|Fluticasone/ Formoterol|See above
15934138|NCT03387241|Drug|fluticasone/ salmeterol|See above
15934139|NCT03387228|Other|Pain education|"Pain education intervention we plan to use is based on Explain Pain developed by Moseley and Butler in 2003. The pain education handout and materials produced in Nepali will be proof-read and pre-tested in 5 - 10 Nepalese with LBP as needed, and corrected, if necessary.
~Dosage: A single (approximately) one hour pain education will be delivered to the PEG.
~Home advice: A printed handout of the pain education material will be provided only to the study participants in the PEG. Participants will be advised to read them (or have family members read them), followed by walking for 30 minutes."
15934140|NCT03387228|Other|Control group|"The control participants will receive physiotherapy care based on the recent clinical practice guidelines. This control group intervention will comprise of: (1) education (advice to remain active); (2) massage to back; (3) superficial heat; and (4) static cycling or (treadmill) walking with the aim to promote physical activity. Although superficial heat is recommended in the acute/subacute LBP, we included this as a common treatment for all types of LBP including chronic LBP, which could be a part of self-management.
~Duration of treatment: 1 hour. Home advice: Participants will be advised to self-manage their back pain based on the information provided. Home exercise leaflet with emphasis on the value of exercise to increase strength and endurance, followed by a 30 minutes walking."
15934141|NCT03387215|Drug|ITI-214|Oral
15934142|NCT03387215|Other|Placebo|Oral
15934143|NCT03387202|Procedure|Laparoscopic lateral suspension with mesh|V-shaped ccm wide and 25cm length mesh strip is prepared from a 30x30cm Prolene mesh (Ethicon J&J).Deep dissection of the uterovesical space is performed.Cutaneous incisions are bilaterally made 3cmsuperoposterior to the anteriosuperior iliac spine.A grasper is introduced retroperitoneally through the subperitoneum holding the beginning part of mesh until reaching the vesicovaginal space in an oblique route rather than transverse.Broad ligament is lifted upward and tunnel is practiced in its lower third.Assistant grasper catches the distal mesh and pulls out through the opposite subperitoneal tunnel.Corner of mesh is fixed to the pubocervical fascia,uterine cervix and isthmus with Absorba Tack™(Covidien, Mansfield,USA).Tension-free lateral mesh suspension is achieved at the desired level
15934144|NCT03387202|Diagnostic Test|Transperineal ultrasound|Vaginal length, bladder neck mobility and pelvic floor biometry with anterioposterior hiatal diameter and pelvic organ descent measurements are measured by transperineal ultrasonography to assess anatomic success in the preoperative and at postoperative first third and sixth months if available.
15934145|NCT03387189|Other|Quality Improvement Project|Simulation education conducted at Regions Hospital for a Quality Improvement project on delivery of impacted fetal head at cesarean section. This is a department-wide, simulation-based educational training required for all Regions Hospital Birth Center staff physicians, residents, nursing staff, and surgical techs.
15934146|NCT03387176|Other|Implementation of a gluten-free diet|Patients will be placed on gluten free diet for 9-12 months.
15934147|NCT03387163|Drug|Sacubitril/Valsartan|commercially available Sacubitril/Valsartan: 24/26; 49/51 ; 97/103
15934148|NCT03387150|Biological|VRC07-523LS|Administered by intravenous (IV) infusion, subcutaneous (SC) injection, or intramuscular (IM) injection, depending on which group participants are in
15934149|NCT03387150|Biological|Placebo|Sodium Chloride for Injection USP, 0.9%; administered by IM injection
15934150|NCT03387137|Biological|RSV 6120/∆NS2/1030s|Delivered as nose drops
15934151|NCT03387137|Biological|Placebo|Delivered as nose drops
15934152|NCT03387124|Other|Breastfed infants|Breastmilk
15934153|NCT03387111|Drug|Aldoxorubicin HCl|Aldoxorubicin hydrochloride
15934154|NCT03387111|Biological|ETBX-011|Ad5 [E1-, E2b-]-CEA
15934155|NCT03387111|Biological|ETBX-021|Ad5 [E1-, E2b-]-HER2
15934156|NCT03387111|Biological|ETBX-051|Ad5 [E1-, E2b-]-Brachyury vaccine
15934157|NCT03387111|Biological|ETBX-061|Ad5 [E1-, E2b-]-MUC1
15934158|NCT03387111|Biological|GI-4000|Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins
15934159|NCT03387111|Biological|GI-6207|Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant CEA proteins
15934160|NCT03387111|Biological|GI-6301|Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Brachyury yeast proteins
15934161|NCT03387111|Biological|haNK for infusion|NK-92 [CD16.158V, ER IL-2]
15934162|NCT03387111|Drug|Avelumab|Recombinant human anti-PD-L1 IgG1 monoclonal antibody
15934163|NCT03387111|Drug|bevacizumab|Recombinant human anti-VEGF IgG1 monoclonal
15934528|NCT03384563|Drug|Dexmedetomidine|Dexmedetomidine 9 arms
15934170|NCT03387111|Drug|nab-Paclitaxel|Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin
15934171|NCT03387111|Drug|Necitumumab|Necitumumab is a recombinant human lgG1 monoclonal antibody.
15934172|NCT03387111|Procedure|SBRT|Stereotactic Body Radiation Therapy
15934173|NCT03387111|Biological|N-803|Recombinant human superagonist interleukin-15 (IL-15) complex [also known as IL-15N72D:IL-15RuSu/IgGI Fe complex1)
15934174|NCT03387098|Drug|Aldoxorubicin HCl|Aldoxorubicin hydrochloride
15934175|NCT03387098|Biological|ALT-803|Recombinant human super agonist interleukin-15 (IL-15) complex
15934176|NCT03387098|Biological|ETBX-011|Ad5 [E1-, E2b-]-CEA
15934177|NCT03387098|Biological|GI-4000|Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins
15934178|NCT03387098|Biological|haNK for infusion|NK-92 [CD16.158V, ER IL-2]
15934179|NCT03387098|Biological|avelumab|Recombinant human anti-PD-L1 IgG1 monoclonal antibody
15934180|NCT03387098|Biological|bevacizumab|Recombinant human anti-VEGF IgG1 monoclonal
15934181|NCT03387098|Drug|Capecitabine|5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine
15934182|NCT03387098|Drug|Cyclophosphamide|2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
15934183|NCT03387098|Drug|Fluorouracil|5-fluoro-2,4 (1H,3H)-pyrimidinedione
15934184|NCT03387098|Drug|Leucovorin|L-Glutamic acid, N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-, calcium salt
15934185|NCT03387098|Drug|nab-Paclitaxel|Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin
15934186|NCT03387098|Drug|lovaza|Omega-3-acid ethyl esters
15934187|NCT03387098|Drug|Oxaliplatin|cis-[(1 R,2 R)-1,2-cyclohexanediamine-N,N'] [oxalato(2-)- O,O'] platinum
15934188|NCT03387098|Procedure|SBRT|Stereotactic Body Radiation Therapy
15934189|NCT03387085|Drug|Aldoxorubicin HCl|Aldoxorubicin hydrochloride
15934190|NCT03387085|Biological|N-803|Recombinant human super agonist interleukin-15 (IL-15) complex
15934191|NCT03387085|Biological|ETBX-011|Ad5 [E1-, E2b-]-CEA
15934192|NCT03387085|Biological|ETBX-051|Ad5 [E1-, E2b-]-Brachyury vaccine
15934193|NCT03387085|Biological|ETBX-061|Ad5 [E1-, E2b-]-MUC1
15934194|NCT03387085|Biological|GI-4000|Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins
15934195|NCT03387085|Biological|GI-6207|Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant CEA proteins
15934196|NCT03387085|Biological|GI-6301|Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Brachyury yeast proteins
15934197|NCT03387085|Biological|haNK for Infusion|NK-92 [CD16.158V, ER IL-2]
15934198|NCT03387085|Biological|avelumab|Recombinant human anti-PD-L1 IgG1 monoclonal antibody
15934199|NCT03387085|Biological|bevacizumab|Recombinant human anti-VEGF IgG1 monoclonal
15934200|NCT03387085|Drug|Capecitabine|5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine
15934201|NCT03387085|Drug|Cisplatin|cis-diamminedichloroplatinum(II)
15934202|NCT03387085|Drug|Cyclophosphamide|2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
15934203|NCT03387085|Drug|5-Fluorouracil|5-fluoro-2,4 (1H,3H)-pyrimidinedione
15934204|NCT03387085|Drug|Leucovorin|L-Glutamic acid, N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-, calcium salt
15934205|NCT03387085|Drug|nab-Paclitaxel|Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin
15934206|NCT03387085|Procedure|SBRT|Stereotactic Body Radiation Therapy
15934207|NCT03387072|Other|Non interventional study|mental stress test and Blood (or salivary) sample
15934208|NCT03387059|Device|Forielle|Participants randomized to receive Forielle endometrial washing (an intrauterine solution) following oocyte retrieval on Study Day 0 (Randomisation).
15934209|NCT03387046|Dietary Supplement|D-aspartate|D-aspartate 2660 milligram (mg) once daily in the form of oral solution for 24 weeks.
15934210|NCT03387046|Drug|Placebo|Placebo matched to D-aspartate once daily in the form of oral solution for 24 weeks.
15934211|NCT03387046|Biological|IFN beta-1a|IFN beta-1a was administered subcutaneously at a dose of 44 microgram (mcg) three times a week for 24 weeks.
15934212|NCT03387046|Drug|Methylprednisolone|Methylprednisolone 1000 mg was administered intravenously once daily for 5 consecutive days.
15934213|NCT03387033|Device|Relaxation response and virtual reality (VR) session|A 10-minute relaxation response (mindfulness and deep breathing) followed by 10-minute immersive VR session.
15934214|NCT03387020|Drug|Everolimus|Given PO
15934215|NCT03387020|Other|Laboratory Biomarker Analysis|Correlative studies
15934216|NCT03387020|Other|Pharmacological Study|Correlative studies
15934217|NCT03387020|Drug|Ribociclib|Given PO
15934218|NCT03387007|Behavioral|Psychosocial support training for school teachers|The intervention for this study was schoolteachers' training on psychosocial support.A clinical psychologist provided 2-day training (a total of 16 hours) training on psychosocial support for the schoolteachers
15934219|NCT03386981|Other|blood and saliva tests|Blood and saliva will be tested for: bone turnover markers, cytokines, chemokines, adipokines, myokines and hormones regulating bone and energy metabolism
15934220|NCT03386968|Behavioral|Active video gaming|"Children will visit Blythedale for 8 sessions, one 45-session visit per week, in place of one of the child's typical physical therapy sessions. During each session, children will play a video game on the X-Box Kinect system, using the games Kinect Adventures and Kinect Sports. The child will first play a Kinect Adventures game, which requires ambulating, ducking, and dodging one's way through an obstacle course."
15934577|NCT03384186|Drug|Danicopan Modified Release Prototype 2|Danicopan (400 mg) oral tablet.
15934222|NCT03386955|Drug|BPI-7711 Capsule|Phase I: BPI-7711 capsule(30mg, 60mg, 120mg, 180mg, 240mg...) Phase IIa: BPI-7711 capsule(with recommend phase II dose)
15934223|NCT03386942|Drug|MORAb-202|Part 1: MORAB-202 intravenous (IV) infusion administered every 3 weeks starting at a 0.3 mg/kg dose and successively increasing doses until DLT. Part 2: MORAb-202 administered IV every 3 weeks at a dose determined in Part 1 until any of the criteria for discontinuation are met.
15934224|NCT03386929|Drug|Avelumab|A human antibody of the immunoglobulin gamma-1 isotype that specifically targets and blocks the Programmed Death ligand (PD-L1) for PD-1.
15934225|NCT03386929|Drug|Axitinib|A selective oral (tablet) inhibitor of tyrosine kinases Vascular Endothelial Growth Factor (VEGF) receptors 1, 2, and 3. These receptors are implicated in pathologic angiogenesis, tumor growth and cancer progression.
15934226|NCT03386929|Drug|Palbociclib|A selective, reversible oral (capsule) inhibitor of cyclin-dependent kinases (CDK) 4 and 6. The inhibition of CDK 4/6 blocks DNA synthesis by prohibiting progression of the cell cycle from G1 to S phase.
15934227|NCT03386916|Procedure|CT scan guide percutaneous biopsy of lytic bone metastases of lung cancer|
15934228|NCT03386903|Device|Ture acupuncture|"Patients receive true acupuncture treatment by Zhoushi coordinated points at the Bai-hui (DU20), Shen-ting (DU24), bilateral Ben-shen (BG13), Shen-men (HT7), San-yin-jiao (SP6) with Deqi sensation. The needles are retained for 20 minutes in every course, three times per week and last for 3 months."
15934229|NCT03386903|Device|Sham acupuncture|Patients receive sham acupuncture stimulation by non-acupoint points (superficial insertion, 0.2 cun, No needle sensation (de qi) is elicited) at the bilateral mid-point between Shuaigu(GB8) and Touwei(ST8), Touwei(ST8) and Yangbai(GB14), front tibia, the junction of biceps and triceps.
15934230|NCT03386877|Procedure|periodontal regeneration|Defects were accessed with the MIST In the test group the obtained micro-grafts enriched in DPSCs were endorsed onto a collagen sponge scaffold (Condress®, Istituto Gentili, Milano, Italy) to form a bio-complex. In the control group the collagen sponge was only hydrated using physiologic sterile solution. The collagen sponge with or without cells was provided to the masked surgeon who filled the intrabony defect. The flaps were repositioned and tension-free primary flap closure was obtained using horizontal internal mattress and interrupted sutures
15934231|NCT03386838|Biological|Nivolumab|Specified dose on specified days
15934232|NCT03386838|Drug|BMS-986205|Administered 100mg orally once daily for a maximum of 104 weeks
15934233|NCT03386838|Biological|Cetuximab|400 mg/m² intravenous administration once only, then 250 mg/m² weekly maintenance until disease progression, unacceptable toxicity, withdrawal of informed consent, or other reason
15934234|NCT03386838|Drug|Cisplatin|Cisplatin (100 mg/m2) every 3 weeks (Up to 6 cycles)
15934235|NCT03386838|Drug|Carboplatin|Carboplatin (AUC of 5 mg per milliliter per minute) every 3 weeks (Up to 6 cycles)
15934236|NCT03386838|Drug|Fluorouracil|1000 mg/m² per day for 4 days, every 3 weeks (Up to 6 cycles)
15934237|NCT03386825|Drug|Regorafenib (Stivarga, BAY73-4506)|Antineoplastic agents, protein kinase inhibitor (L01XE21)
15934238|NCT03386799|Device|E-motion device|Powered assisted Wheelchair with the E-motion device. Outdoor and indoor runs
15934239|NCT03386786|Behavioral|Health Partner|Health Partner is a combination of a mobile application and a web-based portal.
15934240|NCT03386786|Behavioral|Standard Care|Patients randomized to Control will receive pre-printed brochures that outline the steps of the care plan for unilateral TKA and THA, as per standard care provided to any unilateral TJA patient receiving care at Princeton Healthcare System (PHCS).
15934241|NCT03386773|Behavioral|16-week program|16-week program where patients will receive regular health promotion messaging about (a) food, nutrition, and diet; and (b) exercise and physical activity.
15934242|NCT03386773|Behavioral|Patient generated health data|Intervention patients will be asked to track patient generated health data and patient reported outcomes. PGHD elements related to weight management will be collected through a mobile health app loaded on their phones and/or through using a fitness tracker, depending on patient preference, and to share that information with the research team. Patient-reported outcomes (PRO) measures will be collected pre-and-post-intervention. Intervention patients will also be asked to provide answers to patient-reported outcomes measures on a weekly basis.
15934243|NCT03386760|Device|Laser Utilisation PicoSecond|"Laser utilisation for tattoo depigmentation
~1 session every month for a total of 3 sessions"
15934244|NCT03386760|Device|Laser Utilisation Nano-second|"Laser utilisation for tattoo depigmentation
~1 session every month for a total of 3 sessions"
15934245|NCT03386747|Behavioral|Home visits to improve parenting behaviors|Caregivers will be visited twice per month starting from the third trimester in pregnancy up to age three to discuss important health and development behaviors.
15934246|NCT03386747|Behavioral|Center based parenting groups|Caregivers will be invited to early childhood development groups. Groups will meet at nearby centers twice per month. Caregivers will be invited to participate starting from the third trimester up to age 3 of the child.
15934247|NCT03386734|Procedure|SLN biopsy only|In experimental arm, SLN dissection only. A full lymphadenectomy will not be performed. The radical hysterectomy or trachelectomy will be done.
15934248|NCT03386734|Procedure|SLN biopsy + PLN dissection|In active comparator arm, SLN dissection + full lymphadenectomy will be performed.
15934249|NCT03386721|Drug|simlukafusp alfa|simlukafusp alfa will be administered as per the dosage regimen mentioned in arm descriptions.
15934250|NCT03386721|Drug|Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody|Atezolizumab will be administered as per the dosage regimen mentioned in arm descriptions.
15934251|NCT03386721|Drug|Gemcitabine|Single-agent treatment administered as per approved protocol.
15934252|NCT03386721|Drug|Vinorelbine|Single-agent treatment administered as per approved protocol.
15934253|NCT03386708|Procedure|intrauterine injection|intrauterine injection with umbilical cord mesenchymal stem cell (SCLnow 19#); one time/ 15 days, total 4 times
15934254|NCT03386708|Procedure|intravenous injection|intravenous injection with umbilical cord mesenchymal stem cell (SCLnow 19#); one time/ 15 days, total 4 times
15934255|NCT03386708|Biological|umbilical cord mesenchymal stem cell|Treat patients with umbilical cord mesenchymal stem cell (SCLnow 19#), intrauterine injection: 2 * 10^7 cells (2ml)/ intravenous injection: 4 * 10^7 cells (30ml)
15934256|NCT03386708|Drug|Normal saline (NS)|Treat patient with Normal saline (NS): 2ml/30ml
15934257|NCT03386695|Other|Education by Pamphlets|Distribution of pamphlets with information of prevention and early detection of cervical cancer and written as well as pictorial depiction on how to collect cervical self sample for HPV detection.
15934258|NCT03386695|Other|Health education programme|Health education program explaining about prevention and early detection of cancer and education on method of collection of cervical self sample for HPV.
15934259|NCT03386682|Device|ESTYME® MATRIX Breast Implants|Breast implant surgery in breast reconstruction or breast augmentation
15934260|NCT03386669|Drug|F-18|Totally 60 subjects age 20-80 including 20 subjects with a diagnosis of PD,PSP,and CBS. For disease subjects, caregiver should be able to report activities of daily living and their mental status. Patient should be able to give informed consent or have a caregiver give consent with subject assent.
15934261|NCT03386656|Drug|Amchafibrin|Tranexamic acid (Amchafibrin) exerts an antihemorrhagic activity by inhibiting the fibrinolytic properties of plasmin.
15934262|NCT03386656|Other|Saline Solution|Placebo
15934263|NCT03386643|Drug|Bifidobacterium animalis subsp. lactis HN019|The selected patients will receive capsules to be diluted in 15 ml of water containing 6 x 109 CFUs of Bifidobacterium subsp. lactis HN019 for mouthwash twice a day for 4 weeks.
15934264|NCT03386643|Drug|Clobetasol propionate 0.05%|The selected patients will receive capsules to be diluted in 15ml of water containing clobetasol propionate 0.05% for mouthwash twice a day for 4 weeks.
15934265|NCT03386630|Drug|Hyperbaric bupivacaine+Sufentanil|To evaluate in spinal anesthesia for elective cesarean section what association of hyperbaric bupivacaine 0.5% (0.06 mg Cm-1 in height) plus opioid: sufentanil (5 mcg)
15934266|NCT03386630|Drug|Hyperbaric bupivacaine+Morphine|To evaluate in spinal anesthesia for elective cesarean section what association of hyperbaric bupivacaine 0.5% (0.06 mg Cm-1 in height) plus opioid: morphine (0,01 mg)
15934267|NCT03386617|Drug|NEPA|"Day 1 of each chemotherapy cycle:
~1 tablet of NEPA (NETU 300 mg/ PALO 0.50 mg) 1 hour prior to the start of chemotherapy with dexamethasone 12 mg administered orally 30 minutes prior to chemotherapy Days 2 to 3 Dexamethasone. The time and date of intake will be recorded."
15934268|NCT03386604|Dietary Supplement|Whey protein|whey protein 40 g: energy value 160 kcal; carbohydrate 10 g; 25g proteins; total fat 2.3g; saturated fats 1.1 g; trans fat 0 g; dietary fiber 0 g; sodium 157 mg; calcium 264 mg.
15934269|NCT03386604|Dietary Supplement|Maltodextrin|Maltodextrin energy value 160 kcal.
15934270|NCT03386591|Drug|Naloxone|Comparing pharmacokinetics of naloxone
15934271|NCT03386591|Device|Mucosal atomization device and syringe|Injection
15934272|NCT03386591|Device|Narcan|Nasal Spray
15934273|NCT03386591|Device|Intramuscular Auto Injector|Intramuscular injection
15934274|NCT03386578|Drug|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|200 mg/300 mg of FTC/TDF administered orally as a fixed-dose combination tablet once daily
15934275|NCT03386578|Behavioral|Behavioral HIV risk reduction package|HIV risk reduction package, including cohort-appropriate SMS messages. Participants in the PrEP Comparison Component: Cohort 1 will also receive enhanced adherence support, including two-way SMS messaging and tailored counseling with near-real time drug level feedback.
15934276|NCT03386565|Drug|sodium chloride solution|intraoperative IV infusion
15934277|NCT03386565|Drug|Lidocaine|intraoperative IV infusion
15934278|NCT03386552|Drug|Isifera+|Pertubation solution of lidocaine 0.5 mg ml in Ringer-Acetate buffer
15934279|NCT03386552|Drug|Buffer|Pertubation solution of Ringer-Acetate buffer
15934280|NCT03386539|Drug|Everolimus|Everolimus tablet
15934281|NCT03386539|Drug|Tacrolimus|Tacrolimus capsule or liquid suspension
15934282|NCT03386539|Drug|Mycophenolate Mofetil|Mycophenolate Mofetil capsule or liquid suspension
15934283|NCT03386526|Drug|APG-1387 for Injection|Multiple dose cohorts, 30 minute IV infusion, once weekly for 3 weeks of a 21-day cycle
15934284|NCT03386513|Drug|IMGN632|CD123-targeted ADC
15934285|NCT03386500|Drug|BMX-001|BMX-001 at escalating doses in combination with standard RT, 33 fractions to 59.4 Gy, plus Mitomycin at the standard dosing of 10 mg/m2 administered IV bolus at day 1 and day 29 as well as 5FU 1g/m2/d day 1-4 and 29-32.
15934286|NCT03386487|Drug|PF 04457845|Study medication will be administered at 4mg by mouth daily for eight weeks.
15934287|NCT03386487|Drug|Placebo Oral Tablet|Placebo comparator will be administered by mouth daily for eight weeks.
15934288|NCT03386474|Drug|Brolucizumab 6 mg|Administered as opthalmic solution for an intravitreal injection to the study eye
15934289|NCT03386474|Drug|Aflibercept 2 mg|Administered as an opthalmic solution for intravitreal injection to the study eye
15934290|NCT03386461|Behavioral|Exercise training|Combined aerobic and resistive training 3 times a week for 4 months. The strength training will be performed at moderate intensity (i.e., 50-60% of RM), and moderate volume (i.e., 2 to 3 sets per exercise). Endurance training will be performed at moderate- to high-intensity (i.e., 60-85% of VO2max) in the form of continuous and interval training (for high intensities), respectively. The training intensity will be prescribed individually on the basis of the initial exercise testing. Subjects will be thoroughly instructed on effective home-based exercise and advised to exercise in total 5 days a week.
15934291|NCT03386461|Dietary Supplement|omega 3 supplementation|Capsules with high content of omega 3 fatty acids (Calanus oil) will be taken every day with lunch meal. The content of omega-3 fatty acids (EPA, DHA) per day should reach 250 mg.
15934292|NCT03386461|Dietary Supplement|placebo|Capsules with content of omega 6 fatty acids (sunflower oil) will be taken every day with lunch meal.
15934293|NCT03386448|Drug|Scopolamine and naltrexone|participants will receive scopolamine and naltrexone in buccal drops
15934294|NCT03386448|Drug|placebo arm|participants will receive placebo medications
15934295|NCT03386435|Procedure|remote ischemic preconditioning|Remote ischemic preconditioning was performed following anesthesia induction in donors. The protocol involves 3 cycles of 5-minute inflation of a blood pressure cuff to 200 mm Hg to one upper arm, followed by 5-minute reperfusion with the cuff deflated
15934296|NCT03386422|Behavioral|MSC|Mindfulness and Self-Compassion training
15934297|NCT03386422|Behavioral|CBT|Cognitive-behavioural techniques training
15934335|NCT03386123|Behavioral|Standard Audiological Care|Maintenance of sleep diary at key times. Psycho-education, provision of bedside sound generator.
15934578|NCT03384186|Drug|Danicopan Modified Release Prototype 3|Danicopan (800 mg) oral tablet.
15934298|NCT03386409|Behavioral|Free safe firearm storage device distribution|Participants in the experimental phase of the study receive a safe firearm storage device at the time of study enrollment. They are randomized to receive a free device. Safe firearm storage devices include a California Department of Justice-approved lock box, trigger lock and/or cable lock.
15934299|NCT03386409|Behavioral|Low cost safe firearm storage device|Participants in the experimental phase of the study receive a safe firearm storage device at the time of study enrollment. They are randomized to receive a low cost ($5) device. Safe firearm storage devices include a California Department of Justice-approved lock box, trigger lock and/or cable lock.
15934300|NCT03386396|Dietary Supplement|High protein/low carbohydrate|A high protein/low carbohydrate shake will be given to the child.
15934301|NCT03386396|Dietary Supplement|High carbohydrate/low protein|A high carbohydrate/low protein shake will be given to the child
15934302|NCT03386383|Behavioral|Intervention|Individual session, physical activity tracker, online intervention
15934303|NCT03386370|Device|"Indigo Mechanical Thrombectomy System"|"Removal of acute clot (< 14 days) from the artery causing lower limb ischemia, using the Indigo System by Penumbra"
15934304|NCT03386357|Combination Product|A (pembrolizumab+RT)|Pembrolizumab (200mg absolute, q3w) combined with radiotherapy (12x3Gy) of one, two or three metastases. Only metastases that perspectively require radiotherapy will be treated. The irradiated tumor volume must be at least 10cm³. Radiotherapy of brain metastases is not allowed.
15934305|NCT03386357|Drug|B (pembrolizumab)|Pembrolizumab (200mg absolute, q3w)
15934306|NCT03386344|Drug|Sotagliflozin|Pharmaceutical form: Tablet; Route of administration: Oral
15934307|NCT03386344|Drug|Placebo|Pharmaceutical form: Tablet; Route of administration: Oral
15934308|NCT03386331|Behavioral|diet and exercise|Diet and lifestyle intervention
15934309|NCT03386318|Drug|Oxycodone|Serum concentration per hour from 1 to 5 h
15934310|NCT03386305|Drug|EnvarsusXR|Patients randomized to study drug will be converted to EnvarsusXR once daily.
15934311|NCT03386305|Drug|Tacrolimus|Patients continue to take Tacrolimus BID, as a part of routine care.
15934312|NCT03386279|Drug|PF-04965842|one single dose of 600 mg by mouth
15934313|NCT03386279|Drug|Moxifloxacin|one single dose of 400 mg by mouth
15934314|NCT03386279|Drug|Placebo|one single dose by mouth
15934315|NCT03386253|Device|active tDCS|two 13 minute tDCS sessions separated by 20 minutes in between
15934316|NCT03386253|Device|sham tDCS|sham tDCS session given for same length of time as active
15934317|NCT03386240|Drug|Vicryl-plus, monocryl-plus, PDS-plus (Triclosan-coated Sutures)|The intervention consists of using Plus group (Triclosan-coated Sutures)
15934318|NCT03386240|Other|Vicryl, monocryl, PDS (not coated with triclosan)|Consists of equivalent sutures (not coated with triclosan) during cesarean delivery.
15934319|NCT03386227|Other|Withholding antibiotic prophylaxis|Our intervention will be a deviation from our current standard of care which is universal antibiotic prophylaxis, even in low risk populations. Our intervention will be withholding antibiotic prophylaxis in low risk populations.
15934324|NCT03386201|Drug|Intravenous Methylene blue|Methylene blue fluorescence cholangiography during laparoscopic cholecystectomy
15934325|NCT03386188|Device|Transcranial Magnetic Stimulation (TMS)|Transitory inactivation of the posterior parietal cortex and measure of sensorimotor integration.
15934326|NCT03386188|Device|Electrical Muscle Activity (EMG)|Electrodes for the collection of EMG activity will be glued on the skin next to the first interosseus dorsalis muscle, the Abductor digiti minimi, the Extensor carpi radialis and the Abductor pollicis brevis. EMG signals will be stored on computer for off-line analysis using Signal © software (Cambridge Electronic Design, Cambridge, UK)
15934327|NCT03386175|Device|therapy with negative pression and instillation|therapy with negative pression and instillation
15934328|NCT03386162|Drug|Alpelisib|fulvestrant (500 mg intramuscular [as two 5 mL injections] every 28 days ± 3 days, with an additional injection on 15 after the first administration + Alpelisib (300 mg by mouth once daily, in a 21-day cycle). Premenopausal women will receive LH-RH analogs in addition every 28 days ± 3 days.
15934329|NCT03386162|Drug|Chemotherapy|maintenance chemotherapy, meaning the same chemotherapy regimen used during the first 6-8 cycles (investigator's choice) or no antineoplastic treatment in case of toxicity after 4 full cycles.
15934330|NCT03386149|Drug|Bosinji|"Product name : Bosinji Granule Manufacturer : Tsumura & Co. Ingredient : Bosinji granule 2.5g (Bosinji extract 1.523g)
~Bosinji extract is composed of following proportion of ingredient
~Rehmannia Root 1.7g
~Achyranthes Root 1.0g
~Cornus Fruit 1.0g
~Dioscorea Rhizome 1.0g
~Psyllium Husk 1.0g
~Alisma Rhizome 1.0g
~Hoelen 1.0g
~Moutan Root Bark 1.0g
~Cinnamon Bark 0.3g
~Pulvis Aconiti Tuberis Purificatum 0.3g"
15934331|NCT03386149|Drug|Loxonine tab.|Product name : Loxonine tab. Manufacturer : Dong Wha Pharm. Co., Ltd Ingredient : Loxoprofen Sodium 68.1mg (Loxoprofen 60mg)
15934332|NCT03386149|Procedure|Acupuncture|"Acupuncture treatment will be performed on 20 predefined acupoint using 0.25mm x 40mm acupuncture needle. The time for needle retaining is 15 minutes.
~Both EX-B2 of herniated intervertebral disc level, its upper level and its lower level (6 acupoints)
~Both side BL24, BL25, BL26, EX-B7, BL28 (10 acupoints)
~Symptomatic side GB30, GB34, BL57, ST36 (4 acupoints)"
15934333|NCT03386136|Drug|100% Oxygen|To provide hospitalized ileus or pseudo-obstruction patient with 100% oxygen via non-rebreather face mask, for 6 hours
15934334|NCT03386123|Behavioral|Cognitive Behaviour Therapy for Insomnia|Continuous maintenance of sleep diary, cognitive behaviour therapy, including cognitive restructuring, and behavioural change focusing on sleep restriction and safety behaviours.
15969621|NCT03115099|Drug|Liraglutide|Administered subcutaneously
15934336|NCT03386123|Behavioral|Sleep Support Group|Maintenance of sleep diary at key times. Social support focused on tinnitus and sleep problems.
15934337|NCT03386110|Behavioral|Couples Health Project (CHP)|The CHP intervention focuses on addresses drug use and HIV transmission risk by enhancing dyadic communication skills and motivation to work towards shared health goals. The last session of the CHP intervention consists of a Couples HIV Testing and Counseling (CHTC) session.
15934338|NCT03386110|Behavioral|Education|The Education intervention consists of a 3-session health education intervention that addresses sexual risk and substance use through a lecture and question and answer format with a male couple. Additionally, the last session of the education intervention consists of a Couples HIV Testing and Counseling (CHTC) session.
15934339|NCT03386097|Other|Collection of interstitial fluid, skin biopsies and blood|Collection of interstitial fluid, skin biopsies and blood
15934340|NCT03386084|Device|microwave diathermy|Application of microwave diathermy with Monopolar CapacitiveResistive Radiofrequency Therapy (INDIBA)
15934341|NCT03386071|Drug|Trametinib 2 mg|The dosage of trametinib for oral administration is 2mg once daily.
15934342|NCT03386058|Device|Temporary device deactivation|Patient-controlled, temporary deactivation of implanted device
15934343|NCT03386045|Radiation|Optimal SBRT|Two thirds of the participants in this group will get the SBRT (5 treatments) and one third will get standard treatment (60 Gy in 20 treatments)
15934344|NCT03386045|Radiation|Optimal Booster|"Two thirds of the participants in this group will get the two high precision radiotherapy plus 20 doses of standard external beam radiotherapy (ie the Booster approach|) and one third will get the standard treatment (60 Gy in 20 treatments)"
15934345|NCT03386032|Drug|Investigational OTC Cream|Investigational Over the Counter (OTC) Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as moisturizer.
15934346|NCT03386032|Drug|0.05% Desonide|"Rx Steroid applied topically, twice daily, once in the morning and once in the evening, for 8 weeks to all atopic dermatitis lesions.
~Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to whole body as body moisturizer, except atopic dermatitis lesions."
15934347|NCT03386032|Other|Placebo Cream|Placebo Cream applied topically, twice daily, for 8 weeks, once in the morning and once in the evening, to atopic dermatitis lesions and whole body as body moisturizer.
15934348|NCT03386019|Other|Lymphatic massage|One certified physical therapist will perform the massage regimens and techniques adapting from Swedish massage such as effleurage and petrissage that will be used in the massage group. Participants will first lay down in prone position, and the massage leg will be supported on the therapist's leg or on pillows with legs being positioned at approximately 30 degrees of knee flexion. This can promote venous return of the lower legs and also keep the ankle plantar flexors in a relative low muscle tension position. After positioning, long strokes will be applied from the distal to proximal part of gastrocnemius with approximately 20 repetitions and then 20 repetitions of circular strokes would be applied at the popliteal fossa. Finally, therapist will knead around participant's Achilles tendon for 10 repetitions.6 The combination of the techniques mentioned above will repeat 3 times in each subject, and the total duration of massage will be approximately 5 minutes.
15934349|NCT03386019|Other|Static stretching|For the static stretching group, participants will perform the standing gastrocnemius stretches. First, participant stands facing a wall and put the stretched leg behind the body. Physical therapist will ask the participant to slightly flex the front leg, and keep back leg extended with heel on the ground. Both toes will be positioned pointing forward. Participant will then be asked to lunge forward slowly until the calf muscles on the back leg feeling stretched. Participant will hold in this position for 60 seconds and repeat 3 times.
15934350|NCT03386019|Other|Cold water immersion|In the cold-water immersion group, participant's lower leg will be put in a bucket filled with cold water for 10 minute. The temperature of the water will be kept in 11-15 degrees Celsius.52 The water level should reach participant's fibular head to ensure complete immersion of the lower leg.
15934351|NCT03386006|Behavioral|Noom Coach for Bariatric Health|Noom Coach for Bariatric Health offers a sustainable, low-cost, coach-led intervention, and an innovative solution to issues with pre-bariatric surgery weight loss. The intervention will take place over 8 weeks.
15934352|NCT03385993|Device|Technology based guided meditation and relaxation|Subjects will be guided through a mediation and relaxation exercise on a tablet or virtual reality headset for up to an hour each day.
15934353|NCT03385980|Other|Proteomic analysis|Proteomic analysis of tissues collected from all sites of disease, guided by either imaging performed prior to the patient's death or post-mortem findings. Peripheral blood mononuclear cells (PBMC) will be collected with the purpose of identifying somatic changes occurring specifically in the tumor cells and not in normal DNA of the same patient.
15934354|NCT03385967|Drug|Dexmedetomidine|Addition of Dexmedetomidine in block .25mcg/kg of dexmedetomidine
15934355|NCT03385967|Drug|ropivacaine|Standard of care 0.5%ropivacaine
15934356|NCT03385954|Other|Intervention|The distance eduacation group course has a workload of 8 hours and will be developed over 2 weeks. It is suggested that students have a minimum of 1 hour of study per day. The course will consist of work tips, clarifications and procedures for the prevention of RIS/WRMD physical training tips to improve cardiovascular condition and, of strength and flexibility, available literature and theoretical evidence that should be answered through the knowledge acquired in the EAD course of prevention of LERDORT from the HCPA's Physiatrics and Rehabilitation Service. This Course will be available through moodle.
15934357|NCT03385954|Other|Control|will receive a lecture of 30 minutes.
15934358|NCT03385928|Drug|Tranexamic Acid|Investigational product given within 2 hours of symptom onset
15934359|NCT03385928|Drug|Normal saline|Placebo given within 2 hours of symptom onset
15934360|NCT03385915|Procedure|Aortic valve replacement|Transcatheter or surgical aortic valve replacement for severe aortic valve stenosis
15934361|NCT03385902|Other|optimal start time|patients will start hemodialysis when their DIFE reach 35, and can not wait if the DIFE decline to 30.
15934362|NCT03385902|Other|late start time|patients will start hemodialysis when their DIFE less than 30
15934363|NCT03385889|Procedure|Cervical Spine Mobilization|C1/2 graded mobilizations (Grade III/IV) provided to C1/2 segment on ipsilateral side of unilateral headache. Mobilizations will be completed for 3 sets of 30 seconds.
15935075|NCT03380403|Other|Ciprofloxacin|antibiotics and or surgical debridment
15934364|NCT03385889|Procedure|Cervical Spine Manipulation|C1/2 manipulation (Grade V) provided to C1/2 segment on ipsilateral side of unilateral headache. The goal of the manipulation technique is to elicit an audible cavitation. If no cavitation is achieved upon the first attempt, a second and final attempt will be completed. No more than two attempts will be utilized per each subject in this allocated group.
15934365|NCT03385876|Genetic|Genomic sequencing and molecular diagnostic results, if any|Samples will be stored in the pediatric genomic biorepository. A subset of samples will undergo genetic/genomic analysis.
15934366|NCT03385863|Drug|Surfactant, Pulmonary，Curosurf|All NRDS were given an early endotracheal infusion of Curosuf, with an initial dose of 200mg/kg, and if the condition needed to be repeated. Compare the therapeutic effect of pulmonary surfactant of infants at different gestational ages and to investigate whether exogenous surfactant replacement therapy is effective for all newborns with RDS.
15934367|NCT03385863|Other|Perinatal risk factors of NRDS|Compare the perinatal risk factors that were closely related to NRDS between early preterm infants with RDS and near term/term infants with RDS.
15934368|NCT03385850|Other|enteral nutrition|early enteral nutrition group or delayed enteral nutrition group
15934369|NCT03385824|Behavioral|Self-Advocacy for Independent Life (SAIL)|SAIL program is based on an interactive workshop model. In -person sessions will focus on: enhancement of self-efficacy beliefs; enhancement of knowledge of TBI self-advocacy information; group process to instill hope and universality; and practice of self-advocacy behaviors in a supportive neuro-rehabilitation structured group environment.
15934370|NCT03385811|Other|no intervention, only questionnaires survey|questionnaires survey
15934371|NCT03385798|Procedure|Endowrist|Anastomosis made by Endowrist
15934372|NCT03385798|Procedure|Endo-GIA|Anastomosis made by Endo-GIA
15934373|NCT03385772|Procedure|Sphenopalatine ganglion block|The patient will be placed supine, with head in sniffing position. Two long cotton-tipped applicators will be soaked in 4% lidocaine for 30 seconds. An anesthesia provider, after visually inspecting each nostril for any sign of deformity or blockage, will perform the block. A cotton tipped applicator will be inserted into one nostril at an angle perpendicular to the face, and will be advanced to the back of the nasopharynx until resistance is met. The procedure will be repeated in the other nostril. If the patient experiences any pain or discomfort, the physician will stop and redirect the applicator. The applicators will be left in place for 10 minutes, and then removed by the anesthesia provider.
15934374|NCT03385759|Procedure|Unicompartmental knee arthroplasty|Implant to replace the medial compartment of a patient with knee osteoarthritis
15934375|NCT03385759|Procedure|Total knee arthroplasty|Implant to replace the knee joint of a patient with knee osteoarthritis
15934376|NCT03385746|Other|polyamide|metal reinforced polyamide denture base material
15934377|NCT03385746|Other|heat cured acrylic resin|conventional heat cured acrylic resin denture base material
15934378|NCT03385733|Other|inspiratory muscle training|The treatment group received IMT. Patients were trained using an inspiratory threshold-loading device
15934379|NCT03385720|Procedure|modified neck dissection|Modified neck dissection with preservation of submandibular gland. The submandibular gland is preserved during neck dissection.
15934380|NCT03385720|Procedure|traditional neck dissection|traditional neck dissection without preservation of submandibular gland
15934381|NCT03385707|Device|Dexcom continuous glucose monitor and activity monitor|Participants will wear the Dexcom continuous glucose monitor and activity monitor for two weeks. They will not be able to see sensor glucose values. A stool sample will be collected to determine if there is a relationship between postprandial glycemia patterns and microbiome composition.
15934382|NCT03385694|Diagnostic Test|Assessment|Pelvic coronal X-ray, proprioceptive test with Delos system, questionnaires administration, orthopaedic, physiatric and prosthetic assessment
15934383|NCT03385681|Other|Tailored Educational Intervention|The intervention will be a one-day seminar for nurses working at the units, with lectures and workshops with main focus on the subjects showing the lowest pediatric pain management competence. In addition, there will be clinical supervision in pediatric postoperative pain management (two or three days per unit). The intervention will be conducted by two experts (nurse and physician) in pediatric postoperative pain management. After the intervention there will be different reminders every week for the first month, and then every month (in different forms) about pediatric pain management during six months of time.
15934384|NCT03385668|Drug|Pirfenidone|Pirfenidone at a dose of 2403 mg/day for 50 weeks, after a 2 weeks period of titration (801 mg/day for one week then 1602 mg/day for one week).
15934385|NCT03385655|Drug|Adavosertib|250mg, may dose escalate to 300mg if no drug-related GI tox in cycle 1
15934386|NCT03385655|Drug|Savolitinib|600mg once daily, orally.
15934387|NCT03385655|Drug|Darolutamide|600mg twice daily, orally.
15934388|NCT03385655|Drug|CFI-400945|Dose level assigned at enrollment, starting at 32mg/day on Days 1-7 and 15-21 or 15-28 depending on toxicity experienced.
15934389|NCT03385655|Drug|Ipatasertib|400mg daily 3 weeks on, 1 week off
15934390|NCT03385655|Drug|Durvalumab and Tremelimumab|Durvalumab 1500mg day 1 every 4 weeks; Tremelimumab 225mg day 1 cycle 1
15934391|NCT03385655|Drug|Carboplatin|AUC 5 IV 60min Day 1 q 21 days
15934392|NCT03385642|Device|ChondroMimetic|ChondroMimetic is a single-use, biphasic implant that serves as an osteochondral scaffold for the repair of cartilage defects in the knee
15934393|NCT03385629|Behavioral|CSM theory-based didactic education and skills training|Common-Sense Model of Self-Regulation (CSM) theory-based education and skills training for the provider to teach him/her to communicate core oral health facts to parents, provide a prescription to take their child to the dentist together with a list of Medicaid-accepting dentists in the area, and document the oral health encounter in EMR.
15934394|NCT03385629|Other|AAP-based didactic education|American Academy of Pediatrics (AAP) based oral health education and follow the usual care for oral health assessment recommended by AAP guidelines.
15934395|NCT03385629|Other|Practice EMR changes|Enhancements to the EMR system to include oral health documentation (four questions) which will be implemented prior to enrolling any parent/caregiver and child participants into the study.
15934396|NCT03385616|Device|Gala Airway Treatment System|The Gala Airway Treatment system is a device-based, energy delivery system that delivers energy to ablate soft tissue such as the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope.
15934397|NCT03385603|Device|Dilator|Both groups will have a home program consisting of dilators which are progressive in size. The standard care group will use manufacturer instructions to progress in size of dilators, while the experimental group will use self-reported levels of fear to progress in size of dilators.
15934398|NCT03385603|Behavioral|Fear-Based Questionnaires|Series of questionnaires used to facilitate emotional awareness associated with vaginal and decreased sexual arousal.
15934399|NCT03385590|Dietary Supplement|Soy-fiber-maize|Two servings of soy-maize porridge fortified with soy fiber (1.3 g per serving) will be consumed by the children each day for a period of six months.
15934400|NCT03385590|Dietary Supplement|Maize|Two servings of maize porridge will be consumed by the children each day for a period of six months.
15934401|NCT03385577|Behavioral|Stilling the Waters of Uncertainty: A yoga program for women with gynecologic, gastrointestinal (GI), or thoracic cancer|'Stilling the waters,' the prominent theme of this program, is drawn from the core principle in yogic philosophy. It uses breath techniques and physical postures to cultivate inner peace and an ability to live in the present moment. The emphasis on stilling the fluctuations of uncertainty is a direct allusion to the intrusive and inherently unknown future, which characterizes the core experience of Fear of Cancer Recurrence (FCR). This is especially true among gynecologic, gastrointestinal (GI), or thoracic cancer patients for whom the likelihood of recurrence is quite high. An additional motif throughout the program is the lotus flower. The symbolic importance of the lotus in yogic culture is due to its requiring thick muddy waters for ideal growth. The metaphor of cancer as the muddy waters will be used to cultivate benefit-finding and acceptance regarding the mental and physical challenges participants endured during their initial diagnosis and treatment.
15934402|NCT03385564|Drug|BI 655064|subcutaneous injection
15934403|NCT03385564|Drug|Placebo|subcutaneous injection
15934404|NCT03385551|Drug|Estradiol|Estradiol or Promestriene depending on the arm
15934405|NCT03385538|Drug|Clopidogrel|increasing doses of clopidogrel depending on PRU values (75-300 mg)
15934406|NCT03385525|Drug|BIIB074|Administered as specified in the treatment arm
15934407|NCT03385525|Drug|Valproic Acid|Administered as specified in the treatment arm
15934408|NCT03385512|Behavioral|OPEN High Touch|This arm will contain three components: (a) a pre-visit questionnaire delivered through the patient portal of the EHR, asking patients what they most want to discuss with their physician in the upcoming visit; (b) an animated video for patients providing coaching on how to best prepare for their upcoming visits and get the most from the visits; and (c) Standardized Patient Instructor (SPI) providing communication coaching for physicians on how to incorporate what matter most to patients in the visit, with empathy, and clarity.
15934409|NCT03385512|Behavioral|OPEN High Tech|The patient components of the intervention will be identical to the patient components of the High Touch arm (i.e., the pre-visit survey and patient coaching video). The difference will be in the PCP training: we will replace the in-person SPI with a mobile app program.
15934410|NCT03385512|Behavioral|ASK Poster in Exam Rooms|This arm is intended to activate patients by encouraging them to ask three questions during their primary care visit: (1) What are my options? (2) What are the possible benefits and risks of each option? (3) How likely are the benefits and risks of each option to occur to me? This will involve placing posters with these questions in all exam rooms used by providers in clinics randomized to the ASK arm of the trial.
15934411|NCT03385499|Biological|blood additional samples|additional samples of mother's blood and umbilical cord at delivery
15934412|NCT03385486|Biological|TBX-3400|Autologous transfusion
15934413|NCT03385473|Genetic|Pharmacogenomic index|All patients will have a blood sample drawn at randomization visits for PG analysis. For patients in the PA arm, the sample will be processed immediately to obtain the PG results and the subsequent index within 10 days. As soon as the results are available, the project team will contact the attending physician to propose the dosing adequation according to the pharmacogenomic index. PG analysis will be performed once for each patient.
15934414|NCT03385473|Diagnostic Test|Therapeutic drug monitoring|The patients included in the Pharmacological Adequation arm will have a TDM according to this schedule: day +14 (±3), +28 (±3), and +168 (±3). If there is an abnormal value (out of the therapeutic range), we will proceed to adjust the prescription.
15934415|NCT03385460|Other|ESWL BOTOX|ESWL after intrravesical BOTOX
15934416|NCT03385447|Behavioral|Physical Activity|Participants underwent 12-weeks of exercise prescription aimed at the federal guidelines (3 days/week).
15934417|NCT03385434|Device|Endorings-2|292 patients with an indication for screening colonoscopy will be included. 146 patients will receive a standard colonoscopy and 146 patients will receive an Endorings-2 assisted colonoscopy (1:1 standard colonoscopy vs Endorings-2-assisted colonoscopy).
15934418|NCT03385408|Device|HIRO® 3.0|Patients will receive pulsed Nd:YAG (yttrium aluminum garnet) laser, produced by HIRO 3.0 device (ASA, Vicenza, Italy). The total energy deliver to the patient during one session will be 3.000 J through three phases of treatment. HILT will be applied for a total of 4 weeks (three sessions/week).
15934419|NCT03385408|Device|Sham laser|For sham laser, the patient will attended the physical therapy clinic three times a week for 4 weeks and receive sham laser. It is applies the same time than experimental one but with 0 W.
15934420|NCT03385395|Drug|OctaAlpha1|For OctaAlpha1 the standard weekly dose of 60mg/kg will be given for 24 consecutive infusions
15934421|NCT03385395|Drug|Glassia|For Glassia the standard weekly dose of 60mg/kg will be given for 24 consecutive infusions
15934422|NCT03385382|Drug|Dexamethasone intravitreal implant 0.7 mg|Intravitreal Implant of dexamethasone
15934423|NCT03385382|Drug|Ranibizumab Injection|Injection of ranibizumab
15934424|NCT03385369|Drug|MEDI0382|Single dose of MEDI0382
15934425|NCT03385369|Drug|Placebo|Single dose of placebo
15934426|NCT03385356|Drug|Vitamin D|Vitamin D supplementation of 1000IU vs 4000IU vitamin D per day for four months during winter time, when levels of vitamin D in serum of MS patients are especially low.
15934427|NCT03385343|Diagnostic Test|VLE imaging for staging EAC|Volumetric Laser Endomicroscopy (VLE) imaging for staging Esophageal Adenocarcinoma (EAC)
15934428|NCT03385330|Other|LOWER oxygen saturation target group|We will randomize infants with moderate or severe BPD to lower SpO2 target ranges. The study team will then use novel technology to monitor infants starting at randomization, continuing after discharge and until 6 months corrected age, titrating supplemental oxygen to achieve these target SpO2 ranges.
15935195|NCT03379428|Drug|Ibrutinib 560 mg|560 mg by mouth daily
15934429|NCT03385330|Other|HIGHER oxygen saturation target group|We will randomize infants with moderate or severe BPD to higher SpO2 target ranges. The study team will then use novel technology to monitor infants starting at randomization, continuing after discharge and until 6 months corrected age, titrating supplemental oxygen to achieve these target SpO2 ranges.
15934430|NCT03385317|Behavioral|Mindfulness|
15934431|NCT03385304|Drug|10% povidone-iodine (1% free iodine) in purified water|Participant recruitment will begin with the clinical sites using their assigned pre-operative antiseptic skin solution for all open fracture surgeries for a two-month period.
15934432|NCT03385304|Drug|4% chlorhexidine gluconate (CHG) in purified water|Once the first intervention phase is completed, each site will crossover to the opposite study solution. Each site will need to develop local procedures to ensure a successful crossover. They will use the second solution for all open fracture surgeries for a two-month period, and will then crossover back to the solution in the first intervention phase.
15934433|NCT03385291|Device|music,name,and noise sound|A 5-minute baseline silence was followed by the presentation of three contrasting auditory stimuli(music,name,and noise), with a 2-minute washout silence separating each stimulus
15934434|NCT03385278|Other|rTMS|20HZ Repetitive Transcranial Magnetic Stimulation
15934435|NCT03385265|Behavioral|DIPPer Academy|The DIPPer Academy curricula will build on treatment models guided by the Health Beliefs Model (HBM) and Social Cognitive Theory (SCT). The curricula includes video microlectures, personalize progress reports, and other features delivered via the internet.
15934436|NCT03385265|Behavioral|Standard of Care|Families in the standard of care control group will be instructed to manage their child's T1D as recommended.
15934437|NCT03385252|Other|Eggs|Eggs provided as complementary food for the infant
15934438|NCT03385252|Behavioral|Visits|Twice weekly household visits by study staff
15934439|NCT03385239|Drug|ISIS 678354|ISIS 678354 solution for SC injection.
15934440|NCT03385239|Drug|Placebo|Sterile Normal Saline (0.9% NaCl).
15934441|NCT03385226|Drug|Pembrolizumab|Pembrolizumab is a humanised monoclonal antibody which targets the programmed cell death 1 (PD-1) receptor. It blocks a protective mechanism on cancer cells, and allows the immune system to destroy those cancer cells.
15934442|NCT03385226|Radiation|Radiotherapy|12Gy in 3 fractions
15934443|NCT03385200|Drug|SonoVue|As part of the study therapy supportive ultrasound will be performed with iv Infusion of the chemotherapeutic agent.
15934444|NCT03385187|Device|NightOwl HSAT|Patient wears the NightOwl sensor device
15934445|NCT03385174|Other|Carbon monoxide|Carbon monoxide inhalation
15934446|NCT03385161|Procedure|Botulinum toxin A|
15934447|NCT03385161|Procedure|Ethanol|
15934448|NCT03385148|Drug|68Ga-Sgc8|underwent a standard routine 18F-FDG PET/CT first, and then injected 10~20 MBq 68Ga-Sgc8
15934449|NCT03385135|Drug|Allopurinol|300 mg for 4 weeks then 600 mg for 4 weeks in the active group
15934450|NCT03385109|Device|Surgery|Patients are approached surgically with the Senhance Surgical System
15934451|NCT03385096|Drug|Busulfan (BU)|"Busulfan was administered at 3.2 mg/kg/day on days -8 to -6.
~-7 to -4."
15934452|NCT03385096|Drug|Cyclophosphamide (CY)|Cyclophosphamide was administered at 60 mg/kg/day on days -5 to -4. on days -3 to -2.
15934453|NCT03385096|Drug|Etoposide (VP-16)|"Etoposide was administered at 10 mg/kg/day on days -3 to -2.
~-3 to -2."
15934454|NCT03385096|Drug|Melphalan|Melphalan was administered at 200mg/m2 on day -2.
15934455|NCT03385083|Behavioral|Step count monitoring with consulting|Subject counseled on step counts at initial visit and 2 and 4 weeks
15934456|NCT03385083|Behavioral|Step count monitoring without consultation|Subject counseled on step counts at initial visit
15934457|NCT03385083|Device|Fitbit tracker|Fitbit tracker given to participant
15934458|NCT03385070|Diagnostic Test|Lens examination|The presence of cortical lens opacity was biomicroscopically examined by two researchers using the diffuse, direct, Scheimpflug and retroillumination from the fundus methods.
15934459|NCT03385057|Drug|Ibuprofen|Grape-flavored ibuprofen 100mg/5mL (Leader®) will be dispensed. Ibuprofen will be dosed at 10mg/kg (max dose 600mg) QID (roughly Q6 hours, however we left dosing QID to allow for some flexibility in the dosing schedule to accommodate patient sleeping schedules). The pharmacy will manipulate the volume of each medication using Ora Blend suspension so that for each child, weight-based dosing of each medication will be equivalent in volume. The first dose of study medication will be dispensed 4 hours after the preoperative acetaminophen dose. Thereafter, medication will be dosed QID (or roughly 6 hours apart). Surgeons, nursing staff, and patients and their families will be blinded regarding the type of medication administered.
15934460|NCT03385057|Drug|Acetaminophen|Grape-flavored acetaminophen 160mg/5mL (Leader®) will be dispensed based upon the arm to which each participant has been randomized. Acetaminophen at 15mg/kg (max dose 650mg), dosing will be QID (roughly Q6 hours, however we left dosing QID to allow for some flexibility in the dosing schedule to accommodate patient sleeping schedules). The pharmacy will manipulate the volume of each medication using Ora Blend suspension so that for each child, weight-based dosing of each medication will be equivalent in volume. The first dose of study medication will be dispensed 4 hours after the preoperative acetaminophen dose. Thereafter, medication will be dosed QID (or roughly 6 hours apart). Surgeons, nursing staff, and patients and their families will be blinded regarding the type of medication administered.
15934461|NCT03385044|Procedure|MOVT|ETT cuff will be inflated till the disappearance of audible air leak on auscultation, while abdominal carbon dioxide (CO2) inflation is maintained with peak inspiratory pressure of 25 cm H2O during volume controlled ventilation. The patient will be in the Trendelenburg position.
15934462|NCT03385044|Procedure|VE/VI ratio of Spirometer|ETT cuff will be inflated till the VE/VI ratio meets the initial VE/VI ratio, while abdominal CO2 inflation is maintained with peak inspiratory pressure of 25 cm H2O during volume controlled ventilation. The patient will be in the Trendelenburg position.
15934463|NCT03385031|Other|CBCT imaging|CBCT imaging at first and last fraction of radiotherapy treatment
15934492|NCT03384823|Drug|EDP-938|Subjects will receive either a single dose of EDP-938 on Day 1 only (SAD) or a single dose of EDP-938 starting on Day 1 through Day 7 (MAD).
15934493|NCT03384823|Drug|Placebo|placebo to match EDP-938
15934579|NCT03384173|Device|Near Infrared Spectroscopy|Application of regional NIRS sensors to brain and kidney sites in the first 48 hours after birth to monitor regional tissue oxygenation for the first 7 days of age.
15934464|NCT03385018|Procedure|Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by laparoscopic approach|"Total gastrectomy with D2(D2-10) lymph node dissection by laparoscopic approach
~The number of trocars is 6 or less
~Roux-en-Y esophagojejunostomy with any stapling method
~Enough(negative) margin from tumor
~LN station #1, 2, 3, 4d, 4sb, 5, 6, 7, 8a, 9, (10), 11p, 11d, 12a should be examined
~Washing cytology
~Frozen biopsy for surgical margin at surgeons discretion
~Complete omentectomy for grossly serosa-involved tumor
~Combined organ resection only in cholecystectomy and splenectomy
~Indwelling nasogastric tube and drainage catheter at surgeons discretion
~D2 lymphadenectomy should be performed : dissection of LN stations No.4d, 4sb, 4sa, 2, 10 (splenic hilar LN can be left according to the clinical stage), 6, 5, 12a, 8a, 9, 7, 1, 3, 11p, 11d with prevention of pancreatic injury during suprapancreatic dissection"
15934465|NCT03385018|Procedure|Radical total gastrectomy with D2 (D2 - #10) lymph node dissection by open conventional approach|"Total gastrectomy with D2(D2-10) lymph node dissection by open conventional approach
~Roux-en-Y esophagojejunostomy with any stapling method
~Enough(negative) margin from tumor
~LN station #1, 2, 3, 4d, 4sb, 5, 6, 7, 8a, 9, (10), 11p, 11d, 12a should be examined
~Washing cytology
~Frozen biopsy for surgical margin at surgeons discretion
~Complete omentectomy for grossly serosa-involved tumor
~Indwelling nasogastric tube and drainage catheter at surgeons discretion
~D2 lymphadenectomy should be performed : dissection of LN stations No.4d, 4sb, 4sa, 2, 10 (splenic hilar LN can be left according to the clinical stage), 6, 5, 12a, 8a, 9, 7, 1, 3, 11p, 11d with prevention of pancreatic injury during suprapancreatic dissection"
15934467|NCT03384992|Other|Diaphragmatic breathing and relaxation|Education on physiological effects of anxiety, instructions in diaphragmatic breathing and relaxation techniques, and audio-recordings 5-15 minutes in length that provide guided relaxation exercises (autogenic, imagery-based and progressive muscle relaxation).
15934468|NCT03384992|Other|Cognitive restructuring|Education on the thought-emotion connection and exercises designed to better understand cognitions associated with increased anxiety and tools to evaluate and replace anxiety-generating cognitions. Includes an interactive tool (thought record) participants complete to facilitate this process.
15934469|NCT03384992|Other|Scheduled worry practice|Education on the association between avoidance and increased anxiety, and instructions on actively thinking about feared events to reduce avoidance and engage healthy coping strategies. Interactive tool includes a video-based guided worry practice session and an interactive worksheet and timer.
15934470|NCT03384992|Other|Telephone coaching|BCS will receive 5 TeleCoaching calls over a period of 4 weeks, to include one introductory phone call, followed by 4 calls focused each week on the current CSM; if the participant is not randomized to a CSM, TeleCoaching will provide reflective listening and encouragement.
15934471|NCT03384992|Other|Usual care|Includes general health, diet-general information and diet-BCSS (breast cancer survivor-specific) information.
15934472|NCT03384979|Drug|Iopamidol|Contrast agent will be adrministered intravenously using total body weight or lean body weight, calculated with bioelectrical impedance analysis balance.
15934473|NCT03384966|Drug|Selatogrel|Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. It is supplied in sealed glass vials at a strength of 20 mg. The vials with ACT-246475A (hydrochloride salt of ACT-246475) or matching placebo will be reconstituted with 1 mL of water for injection. Further dilution with 1 mL sodium chloride (NaCl) 0.9% will be performed for preparation of the dose of 8 mg selatogrel.
15934474|NCT03384966|Drug|Placebo|Matching placebo for subcutaneous administration.
15934475|NCT03384966|Drug|Selatogrel|Selatogrel is a reversible P2Y12 receptor antagonist for subcutaneous administration. It is supplied in sealed glass vials at a strength of 20 mg. The vials with ACT-246475A (hydrochloride salt of ACT-246475) will be reconstituted with 1 mL of water for injection.
15934476|NCT03384953|Behavioral|Clinical Hypnosis - Group Treatment|group treatment
15934477|NCT03384953|Behavioral|Clinical Hypnosis - Individual Treatment|individual treatment
15934479|NCT03384914|Biological|DC1 Vaccine|"Vaccination Phase: DC1 vaccine will be administered weekly via intranodal injection in weeks 1 to 6 (window 8-21days between vaccines).
~Booster vaccines will be administered at approximately 3 month intervals on months 6, 9 and 12 (with a window +/- 1 month)."
15934480|NCT03384914|Biological|WOKVAC Vaccine|"Vaccination Phase: WOKVAC vaccine will be administered via intradermal injection on weeks 1, 4 and 7 (window +21 days).
~Booster vaccines will be administered at approximately 3 month intervals on months 6, 9 and 12 (with a window +/- 1 month)."
15934481|NCT03384901|Procedure|vitrectomy|Pars plana vitrectomy and ILM (internal limiting membrane) peeling
15934482|NCT03384888|Device|Active tDCS|Transcranial direct current stimulation Duration: 20 minutes; Intensity: 2 mA (miliamps); Placement of the electrodes: anode over the left M1 and cathode region over the right supraorbital region.
15934483|NCT03384888|Device|Sham tDCS|Sham Transcranial direct current stimulation The procedure is the same as for active tDCS, but the stimulation is non-active / sham.
15934484|NCT03384875|Device|CytoSorb|To evaluate the safety and performance of the CytoSorb® device to decrease the incidence or severity of acute kidney injury (AKI)
15934485|NCT03384862|Dietary Supplement|Vitamin B12|5 μg/d vitamin B12 to be given orally. This is a standard nutritional supplement commonly used in the US.
15934486|NCT03384862|Dietary Supplement|Placebo|Placebo pills, with same appearance as intervention pills.
15934487|NCT03384862|Dietary Supplement|Folic Acid|400 μg/d folic acid to be given orally. This is a standard nutritional supplement commonly used in the US.
15934488|NCT03384849|Diagnostic Test|MRI examination|The part of the body that is being scanned and the time of the MRI examination are not relevant.
15934526|NCT03384576|Other|Music intervention|Classical music to be played in the Emergency waiting room
15934494|NCT03384784|Drug|Galantamine|The study will be performed using the 8mg, 16mg and 24mg doses of galantamine hydrobromide-ER. The dosing regimen will be an initial 4 weeks of drug run-up at the lowest 8mg q.d. dose, followed by 16mg q.d. for the following 4 weeks, and the dose will be increased for the last 4 weeks to 24mg. Participants will be instructed to take one 8mg 16mg or 24mg pill (galantamine-ER or placebo) every morning, preferably with food.
15934495|NCT03384784|Drug|Placebo|Matched placebo will be made in-house using lactulose filler in gel capsules. Participants will be instructed to take one pills every morning for 12 weeks.
15934496|NCT03384771|Behavioral|MBSR|There is no study intervention per se, but participants will be teaching or enrolled in public 8-week MBSR classes.
15934497|NCT03384758|Device|Compression Therapy|Therapy of the leg edema with compression stockings class I for three hours, after a short break with compression stocking class II for again three hours.
15934498|NCT03384745|Drug|M1095 (Sonelokimab)|M1095 (Sonelokimab) is a trivalent monomeric nanobody® that neutralizes interleukins IL-17A, IL-17F, and IL-17A/F.
15934499|NCT03384745|Drug|Placebo|Placebo contains no active drug.
15934500|NCT03384745|Drug|Secukinumab|Secukinumab is a human immunoglobulin G1 (IgG1) monoclonal antibody that selectively binds IL-17A.
15934501|NCT03384719|Dietary Supplement|35 g protein (30% milk + 70% rapeseed)|"The daily amount of 35 g of protein is provided as a powder. The powder is packed in two separate sachets to be consumed in the morning and evening. Each sachet contains approximately 60 g of powder. The powder is mixed with liquid before intake.
~Protein powder ingredients (all are food quality):
~Milk protein: Skimmed milk powder (Arla Foods, Viby, Denmark)
~Rapeseed protein isolate: Isolexx® (BioExx, Saskatoon, Canada)
~Other ingredients: lactose, sucrose, flavors, artificial sweeteners. The protein powders for each treatment group are standardized to contain the same amount of energy and lactose per day."
15934502|NCT03384719|Dietary Supplement|35 g protein (54% milk + 46% rapeseed)|"The daily amount of 35 g of protein is provided as a powder. The powder is packed in two separate sachets to be consumed in the morning and evening. Each sachet contains approximately 60 g of powder. The powder is mixed with liquid before intake.
~Protein powder ingredients (all are food quality):
~Milk protein: Skimmed milk powder (Arla Foods, Viby, Denmark)
~Rapeseed protein isolate: Isolexx® (BioExx, Saskatoon, Canada)
~Other ingredients: lactose, sucrose, flavors, artificial sweeteners. The protein powders for each treatment group are standardized to contain the same amount of energy and lactose per day."
15934503|NCT03384719|Dietary Supplement|35 g protein (100% milk)|"The daily amount of 35 g of protein is provided as a powder. The powder is packed in two separate sachets to be consumed in the morning and evening. Each sachet contains approximately 60 g of powder. The powder is mixed with liquid before intake.
~Protein powder ingredients (all are food quality):
~Milk protein: Skimmed milk powder (Arla Foods, Viby, Denmark)
~Other ingredients: lactose, sucrose, flavors, artificial sweeteners. The protein powders for each treatment group are standardized to contain the same amount of energy and lactose per day."
15934504|NCT03384706|Behavioral|Cognitive Processing Therapy (CPT)|"CPT looks at the impact the traumatic event has had on your life and helps you to examine and change unhelpful thoughts and feelings related to the event, yourself, others and the world.
~CPT will be conducted in 5-15, 60 minute sessions held once or twice a week."
15934505|NCT03384706|Behavioral|Accelerated Resolution Therapy (ART)|"ART, like CPT also involves processing thoughts and feelings related to the event, but does this in a different way relying more on visualization or imagination rather than talking.
~ART will be conducted in 5-15, 60 minute sessions held once or twice a week."
15934506|NCT03384693|Drug|Defibrotide|Defibrotide is an anticoagulant and fibrinolytic agent that has been shown to be an effective treatment in other endothelial disorders such as hepatic veno-occlusive disease.
15934507|NCT03384667|Drug|Maekmoondong-tang|MMDT is a Herbal medicine consist of six herbs.
15934508|NCT03384667|Drug|Placebo|The granules do not contain any active ingredients.
15934519|NCT03384628|Device|First pair Senofilcon A contact lens|Fit assessment of the first pair contact lenses.
15934520|NCT03384628|Device|Second pair Senofilcon A contact lens|Fit assessment of the second pair of contact lenses.
15934521|NCT03384628|Device|Third pair Senofilcon A contact lens|Fit assessment of the third pair of contact lenses.
15934522|NCT03384615|Behavioral|Compassion-Focused Therapy|CFT for PGD symptoms in the present project is inspired by two well-established CFT treatment manuals. The first is used for treatment of PTSD (Lee & James, 2011) and the other for treatment of anger (Kolt, 2011). The manual for CFT for PGD adopts both structure and techniques from these into an 8-week, group-based program with weekly 2 1/4-hour sessions. Each session contains elements of psychoeducation on uncomplicated and prolonged grief reactions, identifying unhelpful strategies for self-protection and facilitating use of more helpful strategies, and training an open and compassionate management of grief-related distress through CFT exercises. Between the sessions the participant will train the exercises introduced at the previous session.
15934523|NCT03384602|Other|Dalcroze Eurhythmics Program|music-based multi-task exercise in group setting
15934524|NCT03384602|Other|home exercise strength program|simple strength exercise program to perform individually at home
15934525|NCT03384589|Biological|PCV13|Vaccine against pneumococcal disease
15934529|NCT03384550|Behavioral|Self-regulation coaching|Short (2-5 min.) dialogue with the digital coach who provides information relevant for behavioral self-regulation, such as a goal reminder, the distance between the current step count and the goal and strategies to increase daily steps. Participants are randomized to self-regulation coaching or control (no coaching) on a daily basis.
15934530|NCT03384550|Behavioral|Planning|A dialogue with the digital coach who prompts the participant to either formulate action plans (when and where the participant can go for a walk) or coping plans (strategies to respond to barriers for increasing daily steps) for the upcoming week. Participants are randomized on a weekly basis to action planning, coping planning or control (no planning).
15934531|NCT03384550|Behavioral|Financial Incentives|Participants receive CHF 1 ($1) for each day they meet a personalized adaptive step goal.
15934532|NCT03384550|Behavioral|Charity Incentives|Participants donate CHF 1 ($1) to a charity of choice for each day they meet a personalized adaptive step goal.
15934533|NCT03384537|Combination Product|Listerine total care zero|reducing intra-oral cariogenic microorganism.
15934534|NCT03384537|Combination Product|Chlorhexidine Mouthwash (0.2%).|Chlorhexidine Mouthwash (0.2%).
15934535|NCT03384524|Drug|Bromocriptine 2.5 MG|Administered daily
15934536|NCT03384524|Drug|Metoprolol 25 MG|Administered daily
15934537|NCT03384524|Drug|Tamsulosin 0.4 MG|Administered daily
15934538|NCT03384524|Other|Placebo|Three pills, matching active drugs to be administered daily
15934539|NCT03384511|Drug|Apatinib|Patients will accept apatinib therapy and undergo baseline 18F-ALF-NOTA-PRGD2 PET/CT scans of the whole body after having met all eligibility criterias.
15934540|NCT03384485|Diagnostic Test|antiphospholipid syndrome|blood test for enzyme test,plasma and Lys-3-3 plasma
15934541|NCT03384459|Device|the 308-nm excimer laser|For a total period of 12 months, the 308-nm excimer laser therapy is performed once a month.
15934542|NCT03384446|Other|Tooth-borne treatment|Titanium curettes
15934543|NCT03384446|Other|Implant-specific treatment|Implant brush
15934544|NCT03384433|Biological|exosome|allogenic mesenchymal stem cells derived exosome enriched by miR-124
15934545|NCT03384420|Biological|CD34+ cells enriched with MNV-BLD|Transplantation of autologous stem cell enriched with MNV-BLD (blood-derived mitochondria)
15934546|NCT03384407|Device|Red cell survival in INTERCEPT treated red cells|Red cell recovery/survival analysis of untreated and INTERCEPT treated RBC concomitantly
15934547|NCT03384394|Device|high-flow nasal cannula oxygen|high-flow nasal cannula oxygen
15934548|NCT03384394|Device|Conventional oxygen therapy|oxygen by a standard nasal cannula or nonrebreather mask
15934549|NCT03384368|Device|fractured level screws-distraction|four pedicle screws were implanted into the upper vertebra and the lower vertebral body of the fractured vertebra. Then, immediate reduction and decompression were achieved by applying distraction of rod. Finally, two additional screws were introduced at fracture level
15934550|NCT03384342|Device|Narrow-band UV-B therapy|"Patients treated with NBUVB and showed 75% or more repigmentation rate would be included.
~For a total period of 12 months, narrow-band UV-B therapy is performed once a month."
15934551|NCT03384329|Drug|Resveratrol Pill|Resveratrol 500 mg
15934552|NCT03384329|Drug|Placebos|Placebo Pills
15934553|NCT03384316|Biological|ETBX-051; adenoviral brachyury vaccine|immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year
15934554|NCT03384316|Biological|ETBX-061; adenoviral Mucin-1 (MUC1) vaccine|immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year
15934555|NCT03384316|Biological|ETBX-011; adenoviral Carcinoembryonic antigen (CEA) vaccine|immunotherapeutic vaccine administered subcutaneously every 3 weeks for 3 doses, and then every 8 weeks for up to a year
15934556|NCT03384303|Other|Standardized meal test|Preoperatively and postoperatively standardized meal test
15934557|NCT03384290|Drug|PRS-060|Drug
15934558|NCT03384290|Drug|Placebo|PRS-060 Matching Placebo
15934559|NCT03384277|Drug|Steroid|Methylprednisolone 0.8 mg/kg/day (or equivalent corticosteroid doses) for 3 weeks（then tapering gradually, 8 weeks in total）
15934560|NCT03384277|Drug|Rituximab|375mg/m2 for one dose
15934561|NCT03384277|Drug|Cyclophosphamide|cyclophosphamide 2 mg/kg/day until inhibitor negative (no longer than five weeks)
15934562|NCT03384264|Other|Physical activity|The suspension device was securely attached to a fixed beam. The suspension programme included an initial 10 min warm-up with very low-intensity joint mobility exercises. The central part of the program had a duration of 40 min and included six exercises in which the level of intensity was based on the inclination of the body. The exercises were performed in a split routine, alternating by segment to prevent joint overload. Finally, participants performed 10 minutes of stretching.
15934563|NCT03384251|Behavioral|comprehensive sex education|A comprehensive sex education program to be delivered in approximately six (6) sessions comprising of an introductory lesson on susceptibility and severity of teenage pregnancy, personal and community values, female reproductive system, contraception and decision-making skills.
15934564|NCT03384238|Procedure|Fluorescence Imaging|Undergo fluorescence imaging
15934565|NCT03384238|Biological|Panitumumab|Given IV
15934566|NCT03384238|Drug|Panitumumab-IRDye800|Given IV
15934567|NCT03384225|Drug|Cladribine|
15934568|NCT03384225|Drug|Fludarabine|
15934569|NCT03384225|Drug|Busulfan|
15934570|NCT03384225|Drug|Cytarabine|
15934571|NCT03384212|Drug|Cladribine|
15934572|NCT03384212|Drug|Fludarabine|
15934573|NCT03384212|Drug|Busulfan|
15934574|NCT03384212|Drug|Cytarabine|
15934575|NCT03384199|Radiation|Dose escalation to prostate focal lesion|For each patient the radio-opaque marker (used for treatment verification) will be inserted by ultrasound guidance & local anaesthetic with an 17ga x 30cm brachytherapy needle that has 1.2mm x 3mm one gold marker. The ultrasound probe (as used for transrectal biopsy) will be introduced rectally with the patient in the left lateral position. After measuring the volume of the prostate and determining the desired position (preferably in the corpus of prostate), three gold markers will be inserted as follows: one into right side, one into left side of the base and the third in the apex of the prostate
15934576|NCT03384186|Drug|Danicopan Modified Release Prototype 1|Danicopan (400 milligrams [mg]) oral tablet.
15934580|NCT03384160|Diagnostic Test|Group 1 -Pain monitor|Use of the anesthetic Mepivacaine 2% in third molar extraction and evaluation in postoperative
15934581|NCT03384160|Diagnostic Test|Group 2 -Pain monitor|Use of the anesthetic Articaine 4% in third molar extraction and evaluation in postoperative
15934582|NCT03384147|Dietary Supplement|Drinking|Five different types of alcohol given to participants for 4-5 days in a random sequence for 3 weeks
15934583|NCT03384147|Other|Abstaining|Participants are abstaining from all alcoholic beverages for three weeks
15934584|NCT03384134|Other|Pain Buddy|Pain Buddy is a user interface (application) which contains a personalized avatar (Pain Buddy) to guide children and parents through daily diary entries using mobile devices. The Pain Buddy application has been designed to be used with children age 8-18, receiving outpatient chemotherapy, as well as their parents. Pain Buddy will capture real time pain data from patients and that will ultimately allow for remote monitoring of patient symptoms. Remote symptom monitoring in real time will provide an opportunity for implementation of appropriate interventions, thereby introducing the potential to decrease pain and symptoms and improve quality of life in children with cancer. The use of symptom monitoring and skills training will further increase patient engagement in healthcare.
15934585|NCT03384121|Drug|Rifampin 150 mg, 300 mg capsules and 25 mg/mL oral suspension|Starting Dose (V2): 5 mg/kg/day (max 600mg/day) orally for 2 months followed by a 2 month washout period V4: After washout period, only Non-responders will escalate dose to 10 mg/kg/day (max 600mg/day) orally for 2 months
15934586|NCT03384108|Other|5-13C-Glutamine|Intravenous infusion of 5-13C-Glutamine
15934587|NCT03384108|Other|Bone marrow aspiration|Bone marrow aspiration of bone marrow aspirate
15934588|NCT03384095|Drug|Hyaluronic Acid (HA)|Dosage form: hyaluronic capsules; Dose: 100 mg; Frequency: twice daily; Duration: 26 weeks
15934589|NCT03384095|Other|Placebo|Dosage form: microcrystalline cellulose (MCC) capsules; Dose: approx. 100 mg (determined by weight of HA counterpart); Frequency: twice daily; Duration: 26 weeks
15934590|NCT03384082|Procedure|hysteroscopic treatment|treatment
15934591|NCT03384069|Behavioral|Group-based Cognitive Behavioral Therapy (CBT)|The group-based CBT intervention will include twelve 1-hour group sessions held biweekly for six months. Each sixty-minute session will consist of 15 minutes of Alzheimer's disease (AD) prevention education and approximately 45 minutes of CBT presentations/engagement activities. A physician and a Behavioral Interventionist will collaboratively facilitate the group sessions.
15934592|NCT03384069|Behavioral|Phone-based Cognitive Behavioral Therapy (CBT)|Participants in the phone-based CBT will be asked to reserve a 1-hour period for a phone call from the Behavioral Interventionist biweekly for six months. Text reminders will be sent to the participant's prior the sessions. This intervention will follow the same frequency and format as the group-based CBT and will use an established protocol incorporating the same elements of cognitive behavior change as in the group-based CBT, but without the opportunity for group-interaction.
15934593|NCT03384056|Device|Self Pressurized Airway Device with Blocker|used in adult low risk females undergoing elective gynecological operations
15934594|NCT03384056|Device|Proseal Laryngeal Mask Airway|used in adult low risk females undergoing elective gynecological operations.
15934595|NCT03384043|Behavioral|Smartphone Personal Assistant|Electronic memory aids (e.g., pagers) are known to support memory for goals and intentions (prospective memory) in individuals with cognitive impairment. Smartphone technology has the potential to enhance the benefits of previous electronic memory aids because they can provide reminders not only at the correct time, but also at the correct location.
15934596|NCT03384043|Behavioral|Implementation Intention|Verbally specifying when and where one intends to complete a goal or action (prospective memory) is known to improve the likelihood of later completing that prospective memory. The implementation intention is the best known memory strategy for prospective memory in patients with mild cognitive impairment.
15934597|NCT03384030|Other|adapted STMST|Participants are subjected to the adapted STMST to induce emotional sweating.
15934598|NCT03384017|Other|Transcutaneous Spinal Cord Stimulation and Gait Training|"TSCS will be applied using a midline electrode placed on the skin between spinous process T11 -T12 and two electrodes placed symmetrically on the skin over the lower abdomen as anodes. A symmetrical biphasic rectangular waveform, at 50 Hz and 1 millisecond, is used to provide 30 continuous minutes of stimulation.
~Subjects will participate in 24 two-hour sessions of physical therapy over eight weeks. In each session, subjects will receive TSCS continuously for 30 minutes, using the parameters outlined above. During stimulation, subjects will participate in strengthening, segmental task practice, and gait-based interventions. Participation in gait training will continue following the stimulation period for the duration of the session."
15934599|NCT03384004|Device|Irrigation Technique 1|Irrigation of root canals for this group will be performed using EndoVac Pure, an Apical Negative Pressure Endodontic Irrigation System intended for the delivery and evacuation of endodontic irrigation solutions during root canal procedures. The Endovac Pure is a negative pressure system that utilizes negative pressure irrigation so irrigants are suctioned apically from the pulp chamber to the apical terminus and then through the dental office High Volume Evacuation (HVE) valve (Hi-VAC) system. Endovac Pure is designed to be used with Sodium Hypochlorite (NaOCl or bleach) and EDTA (Ethylenediaminetetraacetic acid). This will be followed by Ultrasonic activation of the sodium hypochlorite solution using Minendo II ultrasonic unit.
15934600|NCT03384004|Device|Irrigation Technique 2|Irrigation of root canals for this group will be performed using the EndoVac pure system without Ultrasonic irrigation. The Endovac Pure is a negative pressure system that utilizes negative pressure irrigation so irrigants are suctioned apically from the pulp chamber to the apical terminus and then through the dental office High Volume Evacuation (HVE) valve (Hi-VAC) system. Endovac Pure is designed to be used with Sodium Hypochlorite (NaOCl or bleach) and EDTA (Ethylenediaminetetraacetic acid).
15934601|NCT03383991|Procedure|Reverse Total Shoulder Arthroplasty|
15934602|NCT03383991|Procedure|Hemiarthroplasty|
15934603|NCT03383978|Biological|NK-92/5.28.z|Intracranial application of NK-92/5.28.z, 1x10E7-1x10E8
15934604|NCT03383965|Biological|ICAR30 T cells|T cells were isolated from peripheral blood from patients enrolled. T cells were transduced with lentivirus bearing anti-CD30 antibody scFV and the activation signals of second generation CART designation. The CART cells were infused into the patients by IV with an escalating dosage.
15934639|NCT03383692|Drug|DS-8201a|DS-8201a is provided as a sterile lyophilized powder of DS-8201a in a glass vial, which will be dissolved and administered as an intravenous (IV) solution
15934605|NCT03383952|Biological|ICAR19 CAR-T cells|T cells were isolated from peripheral blood from patients enrolled. T cells were transduced with lentivirus bearing anti-CD19 antibody scFV and the activation signals of second generation CART designation. The CART cells were infused into the patients by IV with an escalating dosage.
15934606|NCT03383939|Drug|Group A|one nebulization with 250mg alpha-1-antitrypsine diluted in 10ml injectable solution once a day during 1 month. A CR-60 high flow compressor and Ventstream nebulizer were used for nebulization.
15934607|NCT03383939|Drug|Group B|10ml of 0.9% NaCl saline solution nebulised once daily for 1 month. A CR-60 high flow compressor and Ventstream nebulizer were used for nebulization.
15934608|NCT03383926|Procedure|4.5cm suture|Suture confection of the Tobacco-pouch of 4.5cm from the anal margin.
15934609|NCT03383926|Procedure|6cm suture|Suture confection of the Tobacco-pouch of 6cm from the anal margin.
15934610|NCT03383913|Behavioral|Heart Rate Variability Biofeedback|Over a period of 4-6 weeks participants in the intervention arm will learn a series of breathing techniques to determine Heart Rate Variability's effects on physical function, anxiety, depression, fatigue, sleep disturbance, participation in social activities, pain interference and intensity.
15934611|NCT03383900|Device|Inspiratory muscle training|"The inspiratory muscle training program will be of the strength and endurance type, using the POWERbreathe® device and composed of: daily sessions (3 sets of 15 repetitions -inspiration), 4 days a week for 12 weeks. Participants will begin training breathing with a resistance of 20% of their PImax during the first week. After the first week, the resistance will increase between 5% and 10% in each session until reaching 80% of the PImax, which will be maintained during the first month. Upon completion, the PImax value will be re-evaluated and the player will train 80% of this new value during the second month. At the end of the second month, the PImax is evaluated and the player will train the third month with a resistance of 80% of this new value."
15934612|NCT03383887|Drug|Placebo oral capsule|Placebo before sleep
15934613|NCT03383887|Drug|DAW1033D oral capsule|DAW1033D before sleep
15934614|NCT03383874|Combination Product|Probio-Tec BG-VCap-6.5|"The product under investigation is a probiotic containing two microorganisms (Lactobacillus rhamnosus, LGG® and Bifidobacterium animalis subsp. lactis, BB-12®, referred to as LGG® and BB-12®, respectively) and is offered commercially as Probio-Tec BG-VCap-6.5. This composition is formulated to contain a minimum of 1 billion (1.0 x 10^9) CFU (Colony Forming Units) per dose (capsule), including equal numbers of the two strains; i.e. 0.5 x 10^9 CFU of each of LGG® and BB-12® at the time of manufacture. The product will be administered orally."
15934615|NCT03383874|Other|Placebo|This placebo is made almost identically to the Probio-Tec but without active microorganisms.
15934616|NCT03383861|Diagnostic Test|Dual-Energy X-ray Absorptiometry (DXA)|BMD t-score derived from DXA scan
15934617|NCT03383848|Device|Medication Management Software|"The OnTrack Medication Management Software allows patients to track the amount of fertility medication they have at home. When they check off their to do list of medications, it decrements the amount they have at home. It allows them to see when they will run out of medication depending on their current doses (which can change daily). Daily use of the software will be 5-10 minutes daily for approximately 21 days."
15934618|NCT03383835|Dietary Supplement|Omega-3 Supplementation|"DHA 600 milligrams (mg) per day for 6 months
~EPA 300mg per day for 6 months"
15934619|NCT03383822|Drug|Intranasal insulin|Humalog lispro 40 IU intranasally
15934620|NCT03383822|Drug|Intranasal placebo|Diluent intranasally
15934621|NCT03383809|Dietary Supplement|Strawberry juice with Inulin|Mixture of polyphenols and non digestible carbohydrates
15934622|NCT03383809|Dietary Supplement|Strawberry Juice|Source of Polyphenols
15934623|NCT03383809|Dietary Supplement|Inulin|Source of non digestible carbohydrate
15934624|NCT03383796|Procedure|Three dimensional laparoscopic resection for pCCA|Three dimensional laparoscopic resection for pCCA
15934625|NCT03383796|Procedure|Open resection for pCCA|Open resection for pCCA
15934626|NCT03383783|Drug|0 ppm F (placebo, negative control)|Each subject will use this product during one of the four treatment periods in the crossover study design.
15934627|NCT03383783|Drug|250 ppm F as NaF (dose-response control)|Each subject will use this product during one of the four treatment periods in the crossover study design.
15934628|NCT03383783|Drug|500 ppm F as NaF (dose-response control)|Each subject will use this product during one of the four treatment periods in the crossover study design.
15934629|NCT03383783|Drug|1100 ppm F as NaF (positive control)|Each subject will use this product during one of the four treatment periods in the crossover study design.
15934630|NCT03383770|Procedure|Regional Anesthesia Touhy|The patients receive the planned anaesthesia procedure according to the procedure to be performed. Only nerve blockages are carried out, which are considered to be analgesic useful for the planned operations on the basis of typical nerve courses. A touhy cannula is used.
15934631|NCT03383770|Procedure|Regional Anesthesia Facet|The patients receive the planned anaesthesia procedure according to the procedure to be performed. Only nerve blockages are carried out, which are considered to be analgesic useful for the planned operations on the basis of typical nerve courses. A facet cannula is used.
15934632|NCT03383757|Device|SpO2 Sensor application & blood draw|At the start of the procedure, one to two commercial sensors shall be applied to the subject. Readings will be allowed to stabilize. After at least 10 minutes of data collection, arterial blood will be collected and analyzed blood per hospital's standard procedure. Data collection will continue post blood draw for two minutes.
15934633|NCT03383744|Dietary Supplement|vitamin A supplementation|Each child received one capsule of 200,000 IU of vitamin A
15934634|NCT03383731|Procedure|Group 1|the surgical method of standard 3-port 23 gauge pars plana vitrectomy + internal limiting membrane peeling + air-fluid exchange + silicone oil infusion
15934635|NCT03383731|Procedure|Group 2|the surgical method of standard 3-port 23 gauge pars plana vitrectomy + internal limiting membrane peeling + inverted internal limiting membrane insertion + air-fluid exchange
15934636|NCT03383718|Procedure|Revascularisation|Percutaneous coronary intervention or coronary artery bypass surgery
15934637|NCT03383718|Other|Optimal Medical Treatment/OMT|Standard of care in stable coronary artery disease or after acute myocardial infarction.
15934638|NCT03383705|Device|VBeam Prima|Up to four treatments will be performed every 4-6 (±1) weeks.
15934640|NCT03383692|Drug|Ritonavir|Ritonavir is a OATP1B inhibitor; an antiretroviral tablet for oral administration
15934641|NCT03383692|Drug|Itraconazole|Itraconazole is a CYP3A inhibitor; an antifungal tablet for oral administration
15934642|NCT03383679|Drug|Darolutamide|treatment with darolutamide
15934643|NCT03383679|Drug|Capecitabine|treatment with capecitabine
15934644|NCT03383666|Device|PulseRider® Aneurysm Neck Reconstruction Device|Neck Reconstruction Device
15934645|NCT03383640|Other|Active exercises|Active flexion movements every waking hour of the replanted digits
15934646|NCT03383627|Device|Continuous Glucose Monitoring|"The FreeStyle Libre Pro Flash Glucose Monitoring System is a professional continuous glucose monitoring (CGM) device indicated for detecting trends and tracking patterns in persons (age 18 and older) with diabetes. The Freestyle Libre Pro device is FDA approved (PMA# P150021). Participants will use the FreeStyle Libre Pro Flash Glucose Monitoring device according to its approved use, on the back of the arm.
~CGM monitoring will be performed on Day 1 by placing the Freestyle Libre Pro on research subjects for intended use of 14 days.
~Subjects will be advised to return to the research site on Day 14 to remove the CGM device for analysis."
15934647|NCT03383614|Drug|LSF emodepside (BAY 44-4400) or matching placebo|Emodepside administered as an LSF oral solution (1mg/mL)
15934648|NCT03383601|Other|Heated Tobacco product IQOS/heatstick|Heated Tobacco Products: heatsticks heated by iQOS device
15934649|NCT03383601|Other|Smoking combustible cigarettes|Current smoking of combustible cigarettes
15934650|NCT03383588|Drug|Bupivacaine|20 ml subcutaneous bupivacaine (Marcaine) 0.25%. Bupivacaine is an anesthetic which can numb an area of the body to relieve pain during surgery or medical procedures, childbirth, and dental work.
15934651|NCT03383588|Drug|Morphine|intrathecal morphine (Duramorph) 150mcg. DURAMORPH (morphine injection) is a systemic narcotic analgesic for administration by the intravenous, epidural or intrathecal routes. It is used for the management of pain not responsive to non-narcotic analgesics. DURAMORPH (morphine injection) administered epidurally or intrathecally, provides pain relief for extended periods without attendant loss of motor, sensory or sympathetic function.
15934652|NCT03383588|Drug|Fentanyl|intrathecal fentanyl 10 mcg. Fentanyl (also spelled fentanil) is an opioid which is used as a pain medication and together with other medications for anesthesia.
15934653|NCT03383588|Drug|Epinephrine|Epinephrine injection is used along with emergency medical treatment to treat life-threatening allergic reactions caused by insect bites or stings, foods, medications, latex, and other causes. Epinephrine is in a class of medications called alpha- and beta-adrenergic agonists (sympathomimetic agents). It works by relaxing the muscles in the airways and tightening the blood vessels.
15934654|NCT03383588|Other|Saline solution|20 ml subcutaneous NACL 0.9% - saline solution is the placebo
15934655|NCT03383575|Drug|Azacitidine|Given IV or SC
15934656|NCT03383575|Drug|Enasidenib|Given PO
15934657|NCT03383575|Other|Quality-of-Life Assessment|Ancillary studies
15934658|NCT03383562|Procedure|operation in different stages of the day|operation was arranged in the morning ,afternoon or at night
15934659|NCT03383549|Other|Tele-rehabilitation|Each subject undergoes a combined rehabilitation protocol, which will be administered on a daily basis, designed to alternate physical exercises and cognitive training. Each daily session lasts between 30 and 45 minutes. The complete protocol lasts 8 weeks.
15934660|NCT03383523|Drug|Emodepside (BAY 44-4400)|2 tablets compared to the liquid formulation
15934661|NCT03383510|Other|Climate friendly diet|Participants in the 'Climate friendly' group will be assigned a diet generating low emissions of greenhouse gases. The target is to reduce the participants' diet-related carbon dioxide equivalents (CO2e) to 2.5 kg per person and day, which is approximately a reduction by 50% compared the average CO2e, according to a previous study on diet-related CO2e in Sweden. The participants will be instructed to reduce their consumption of beef and dairy products and increase their consumption of plant-foods i.e. fruits, vegetables, legumes and whole-grain cereals.
15934662|NCT03383510|Other|Organic diet|Participants in the 'Organic group' will be assigned an organic diet with very low, or no, content of pesticides. The participants will be instructed to replace at least 50% of their food intake with organic foods.
15934663|NCT03383510|Other|Climate friendly and organic diet|The participants in the 'Climate friendly and organic diet group' will be assigned a combination of a climate friendly and organic diet generating low emissions of greenhouse gas and having very low levels of pesticides. The target is to reduce the participants' diet-related CO2e to 2.5 kg per person and day. The participants will be instructed to replace at least 50% of their food intake with organic products.
15934664|NCT03383510|Other|Control group (Control diet)|"A conventional diet according to the Nordic Nutrition Recommendations (NNR). The participants will get information about the present dietary guidelines and how they can adhere to the guidelines, for example, by implementing the plate model for meals and learning about recommended levels of intake of macronutrients, micronutrients, fiber and energy."
15934665|NCT03383484|Other|OMT|Weekly manipulation of Chapman points and rib raising techniques (osteopathic manipulative treatment)
15934666|NCT03383484|Other|Yoga|Yoga practice 3 times per week for 1 hour each time; hatha yoga poses, asanas, and breathing techniques
15934667|NCT03383471|Biological|Invossa K Inj.|Invossa K Inj.
15934668|NCT03383471|Drug|Placebo|Placebo control
15934671|NCT03383445|Procedure|Edwards|The TAVR procedure will be performed with the Edwards SAPIEN XT or SAPIEN 3 valve (20 0r 23 mm).
15934672|NCT03383445|Procedure|CoreValve|The TAVR procedure will be performed with the CoreValve Evolut R valve system (23 or 26 mm).
15934673|NCT03383445|Procedure|Standard|The choice of the type and size of valve, utilization of additional procedures such as root enlargement will be left at the discretion of heart team of the treating the patient.
15934674|NCT03383432|Device|Intrauterine device|Copper T 380 A
15934675|NCT03383432|Radiation|Ultrasound|Transabdominal ultrasound
15934676|NCT03383432|Procedure|uterine sounding sparing technique|we will insert intrauterine device without using the uterine sound and we will replace this step by ultrasound before insertion
15934677|NCT03383419|Drug|Epclusa|If and when these recipients develop confirmed viremia by HCV PCR, Epclusa® therapy will be administered for a 12-week course.
15934718|NCT03383081|Biological|Low dose mesenchymal stem cells|Human umbilical cord mesenchymal stem cells (SCLnow 19#): group A, 1 * 10^7 cells (5ml);
15934678|NCT03383406|Drug|Ifosfamide, Etoposide, Cytarabine, and Methotrexate (IVAM) Chemotherapy|"Every cycle(4weeks)
~Subject will receive Ifosfamide 1.5 g/m2 over 2 hours for Day1~Day5 by Intravenous infusion, Etoposide 150 mg/m2 over 3 hours on Day1~Day3 by Intravenous infusion, Cytarabine 100 mg/m2 over 1 hour on Day1~Day3 by Intravenous infusion."
15934679|NCT03383393|Drug|Intracoronary bolus of adenosine (adenocor), Integrilin (eptifibatide) or nitroglyzerin (nitronal)|intracoronary drugs
15934680|NCT03383380|Drug|Rapamycin|Gain-of-function (GOF) PIK3CD mutations lead to PI3Kδ hyperactivity, with the downstream mediators Akt and mTOR hyperphosphorylated. The mammalian/mechanistic target of rapamycin inhibitor rapamycin may be effective to control the progress of this disease.
15934681|NCT03383367|Behavioral|Tempo Colo|Reminder letter for people at high risk of colorectal cancer.
15934682|NCT03383354|Other|Sleep-related disturbances (exposure)|Sleep-related disturbances such as sleep-disordered breathing (e.g. sleep apnea), sleep fragmentation, abnormal sleep architecture, and periodic limb movements (PLMs)
15934683|NCT03383341|Dietary Supplement|Cricket Protein Powder|Cricket powder was supplied by Entomo farms and consists of roasted and milled whole crickets.
15934684|NCT03383341|Other|Placebo control|Placebo controls consisted of intervention foods (muffin and smoothie powder packet) that were visually and organoleptically similar to cricket-containing foods but contained no cricket powder.
15934685|NCT03383328|Drug|NSAID + prednisolone, preoperative|Ketorolactrometamol 5 mg/ml and prednisolone acetate 1% w/v eye drops are administered 3 times pr. day, starting 3 days prior to surgery and until 3 weeks after surgery.
15934686|NCT03383328|Drug|NSAID + prednisolone, postoperative|Ketorolactrometamol 5 mg/ml and prednisolone acetate 1% w/v eye drops are administered 3 times pr. day, starting on the day of surgery and until 3 weeks after surgery.
15934687|NCT03383328|Drug|NSAID, preoperative|Ketorolactrometamol 5 mg/ml eye drops are administered 3 times pr. day, starting 3 days prior to surgery and until 3 weeks after surgery.
15934688|NCT03383328|Drug|NSAID, postoperative|Ketorolactrometamol 5 mg/ml eye drops are administered 3 times pr. day, starting on the day of surgery and until 3 weeks after surgery.
15934689|NCT03383328|Drug|Drop-less surgery|A depot of 0.5 ml Dexamethason Krka 4 mg/ml solution for injection/infusion is administered during cataract surgery.
15934690|NCT03383315|Drug|Tramadol|One dose of intravenous tramadol 50mg
15934691|NCT03383315|Drug|Metoclopramide|One dose of intravenous metoclopramide 10mg
15934692|NCT03383315|Drug|Placebo|Sodium chloride 0.9%
15934693|NCT03383302|Radiation|Stereotactic body radiotherapy|Patients will receive a total of 54 Gy if delivered in 3 fractions or 55 Gy if delivered in 5 fractions.
15934694|NCT03383302|Drug|Nivolumab|Nivolumab is a human immunoglobulin G4 (IgG4) monoclonal antibody, that binds to the PD-1 receptor and blocks interaction with its ligands PD-L1 and PD-L2. Nivolumab will be given every 14 days at a flat dose of 240 mg, to be administered as a 30 minute IV infusion.
15934695|NCT03383289|Other|R-REM training|three training modules for front-line long-term care staff to aid in recognition, management and reporting of R-REM
15934696|NCT03383276|Drug|IL-1Ra|custom eye drop to be applied to the left eye.
15934697|NCT03383250|Dietary Supplement|Normal meal|
15934698|NCT03383237|Drug|Apatinib|500mg/d,q.d.,p.o.
15934699|NCT03383224|Other|genotype-guided therapy|treatment based on patient's CHRNA5 rs16969968 genotype
15934700|NCT03383224|Drug|Nicotine patch|
15934701|NCT03383224|Behavioral|Smoking cessation counseling|
15934703|NCT03383198|Drug|Liposomal bupivacaine right injection|Right side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the left side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection.
15934704|NCT03383198|Drug|Liposomal bupivacaine left injection|Left side will have liposomal bupivacaine ultrasound guided PEC II field block injection ; the right side side will have bupivacaine plus dexamethasone ultrasound guided PEC II field block injection.
15934705|NCT03383185|Device|Intrauterine device|Use of Intrauterine device during the follow-up period
15934706|NCT03383185|Drug|Combined Oral Contraceptive|Use of combined oral contraceptive during the follow-up period
15934707|NCT03383185|Drug|Progestin-only pills|Use of progestin-only pills during the follow-up period
15934708|NCT03383185|Drug|Depot-Medroxyprogestereone Acetate|Use of depot-medroxyprogesterone acetato during the follow-up period
15934709|NCT03383172|Behavioral|I Can Problem Solve (ICPS) Program|The 59 sessions of ICPS program explicitly promote cognitive regulation, solving social problems, and emotional learning skills.
15934710|NCT03383146|Drug|Relamorelin|Relamorelin 10 μg injected twice daily for 52 weeks.
15934711|NCT03383146|Drug|Placebo|Placebo injected twice daily for 2 weeks or 52 weeks.
15934712|NCT03383133|Drug|SULT Allosteric Inhibition|A single, therapeutic dose of acetaminophen (APAP, 1.0 g)) or dehydroepiandrosterone (DHEA, 75 mg) is taken orally (with 375 ml of water) either alone or simultaneously with a single, oral, therapeutic dose of mefenamic acid (MEF, 0.75 g). In total, 5 experiments will be performed. Each experiment is performed in duplicate. Compounds are taken prior to eating breakfast. One hour later, the patient has a light breakfast and eats normally thereafter. Urine samples are collected at 15', 30', 1 h, 2h, 3h, 4h, 5 h, 6h, 7h, 8h, 9h, 10h, 11h, and 12h intervals following dosing. The samples are weighed. A 10 ml aliquot is taken from each time point and the aliquots are stored at -20 °C. Samples (0.5 ml) are then transferred to NMR tubes spectra are taken to assess drug metabolites in urine.
15934713|NCT03383120|Device|Laser treatment|Laser treatment of the peri-implantitis lesion includes mechanical debridement of the implant using an ultrasonic device and plastic curettes followed by diode laser sub-mucosal application for 90 seconds. This is repeated two more times at one-week intervals.
15934714|NCT03383120|Procedure|Surgical treatment with adjunctive systemic antibiotics|Mechanical debridement of the implant will be done in a similar manner to the test group (without laser application) followed by open flap debridement 2 weeks after, and post-operative prescription of Amoxicillin and Metronidazole systemic antibiotics 3 times per day for a period of 1 week
15934715|NCT03383094|Drug|Pembrolizumab|Pembrolizumab 200 mg IV infusion every 3 weeks x 20 cycles
15934716|NCT03383094|Radiation|Radiation therapy|70 Gy in 33-35 fractions
15934717|NCT03383094|Drug|Cisplatin|100 mg/m2 Weeks 1, 4, and 7.
15934719|NCT03383081|Biological|High dose mesenchymal stem cells|Human umbilical cord mesenchymal stem cells (SCLnow 19#): group B, 2 * 10^7 cells (5ml)
15934720|NCT03383081|Procedure|Intraarticular injection|Intraarticular injection with human umbilical cord mesenchymal stem cells (SCLnow 19#) with different dose group
15934721|NCT03383068|Drug|Acarbose 100 MG|for metformin uneffective subjects, using acarbose for 3 months
15934722|NCT03383068|Drug|Exenatide|for metformin uneffective subjects, using Exenatide for 3 months
15934723|NCT03383068|Drug|Orlistat|for metformin uneffective subjects, using Orlistatfor 3 months
15934724|NCT03383068|Drug|Metformin|metformin effective subjects,act as control group
15934725|NCT03383055|Biological|CMV-MVA Triplex Vaccine|"CMV-MVA Triplex vaccine administered on days 28 and 56 post-HCT
~TDap administered on Day 56"
15934726|NCT03383042|Drug|Cohort 1 (JP-1366 A mg)|Drug: JP-1366 A mg or JP-1366 Placebo or Esomeprazole 40 mg
15934727|NCT03383042|Drug|Cohort 2 (JP-1366 B mg)|Drug: JP-1366 B mg or JP-1366 Placebo or Esomeprazole 40 mg
15934728|NCT03383042|Drug|Cohort 3 (JP-1366 C mg)|Drug: JP-1366 C mg or JP-1366 Placebo or Esomeprazole 40 mg
15934729|NCT03383042|Drug|Cohort 4 (JP-1366 D mg)|Drug: JP-1366 D mg or JP-1366 Placebo or Esomeprazole 40 mg
15934730|NCT03383042|Drug|Cohort 5 (JP-1366 E mg)|Drug: JP-1366 E mg or JP-1366 Placebo or Esomeprazole 40 mg
15934731|NCT03383042|Drug|Cohort 6 (JP-1366 F mg)|Drug: JP-1366 F mg or JP-1366 Placebo or Esomeprazole 40 mg
15934732|NCT03383042|Drug|Cohort 7 (JP-1366 G mg)|Drug: JP-1366 G mg or JP-1366 Placebo or Esomeprazole 40 mg
15934733|NCT03383042|Drug|Cohort 8 (JP-1366 H mg)|Drug: JP-1366 H mg or JP-1366 Placebo or Esomeprazole 40 mg
15934734|NCT03383042|Drug|Cohort 9 (JP-1366 I mg)|Drug: JP-1366 I mg or JP-1366 Placebo or Esomeprazole 40 mg
15934735|NCT03383029|Behavioral|iEAT Program|The iEAT Program is a six-month long behavioral intervention consisting of 10 biweekly outpatient appointments of about 1 hour in length. The iEAT manual will guide behavioral intervention targeting severe feeding disorders and will involve some combination of escape extinction, reinforcement, and antecedent manipulation of food presentation to lessen the aversive quality of the meal.
15934738|NCT03383003|Drug|Nexium|Esomeprazole ( Nexium )40 mg tid daily for 14 days in the high dose dual therapyarm and 40 mg bid daily for 7 days in the non-bismuth quadruple therapy
15934739|NCT03383003|Drug|Amolin|Amoxicillin 750 mg qid daily for 14 days in the high dose dual therapy and amoxicillin 1 g bid daily for 7 days in the non-bismuth quadruple therapy
15934740|NCT03383003|Drug|Klaricid|clarithromycin 500 mg bid daily for 7 days in the non-bismuth quadruple therapy
15934741|NCT03383003|Drug|Flagyl|Metronidazole (Flagyl) 500 mg tid daily for 7 days in the non-bismuth quadruple therapy
15934742|NCT03382990|Device|DES or BMS|DES or BMS placement during the procedure of PCI in patients with AMI is depend on the operator's decision.
15934743|NCT03382977|Biological|VBI-1901|The vaccine is formulated with GM-CSF and administered intradermally (ID) or AS01B adjuvant and administered intramuscularly (IM) to patients with recurrent GBM.
15934744|NCT03382964|Biological|VLA1553|I.M. vaccination with a live-attenuated Chikungunya virus (CHIKV) vaccine candidate
15934745|NCT03382938|Drug|Dexmedetomidine|WOUND INFILTRATION IN CESAREAN SECTION
15934746|NCT03382938|Drug|Ropivacaine|WOUND INFILTRATION IN CESAREAN SECTION
15934747|NCT03382938|Drug|Dexmedetomidine - Ropivacaine|WOUND INFILTRATION IN CESAREAN SECTION
15934748|NCT03382938|Other|0,9% saline|placebo WOUND INFILTRATION IN CESAREAN SECTION
15934749|NCT03382925|Procedure|cervical interlaminar with lidocaine|Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL 1% lidocaine.
15934750|NCT03382925|Procedure|cervical interlaminar with normal saline|Interlaminar cervical epidural steroid injection at the C7-T1 level with triamcinolone 80 mg (40 mg/mL) + 2 mL preservative saline
15934751|NCT03382925|Drug|Lidocaine|2 mL lidocaine to be used as steroid diluent in group #1 cervical interlaminar procedure.
15934752|NCT03382925|Drug|Triamcinolone Acetonide|2 mL of 40 mg/mL will be used as the steroid in group #1 and group #2 cervical interlaminar procedures.
15934753|NCT03382925|Drug|Normal saline|2 mL of normal saline to be used as steroid diluent in group #2 cervical interlaminar procedure.
15934754|NCT03382912|Biological|Pegilodecakin|Pegilodecakin plus Nivolumab
15934755|NCT03382912|Drug|Nivolumab|Nivolumab Alone
15934756|NCT03382899|Biological|Pegilodecakin|Pegilodecakin plus Pembrolizumab
15934757|NCT03382899|Drug|Pembrolizumab|Pembrolizumab Alone
15934758|NCT03382886|Drug|Nivolumab|"Nivolumab will be administered as a 240mg IV infusion given once every two weeks (+/- 3 days).
~Subjects will remain on study treatment for up to two years or until progression or excessive toxicity"
15934759|NCT03382886|Drug|Bevacizumab|"Bevacizumab will be administered as an IV infusion from 1-10mg/kg in accordance with the appropriate subject cohort being examined as described below:
~Dose level 1: 5 mg/kg intravenously once every two weeks Dose level 2: 10 mg/kg intravenously once every two weeks Dose level -1: 1 mg/kg intravenously once every two weeks
~Dosing is based on actual body weight. There is no dose adjustment for obese or frail individuals. Dosing is recalculated if patient weight changes by more than 10% as reviewed by the principal investigator.
~Subjects will remain on study treatment for up to two years or until progression or excessive toxicity"
15934760|NCT03382873|Behavioral|Group Lifestyle Balance (GLB)|"The intervention includes the following key features: 1) individual case managers or lifestyle coaches; 2) frequent contact with participants; 3) a structured, state-of-the-art, 16-session core-curriculum that teaches behavioral self-management strategies for weight loss and physical activity; 4) a more flexible maintenance intervention, combining group and individual approaches and motivational campaigns; 6) individualization through a toolbox of adherence strategies; and 7) tailoring of materials and strategies utilizing a network of training, feedback, and support."
15934833|NCT03382353|Behavioral|Computerized cognitive training|16 cognitive training sessions (twice a week) supervised by a psychologist, aimed to improve Attention, Processing speed, Memory, Social skills and Intelligence using BrainHQ (www.brainhq.com).
15934761|NCT03382873|Behavioral|Group Lifestyle Balance Plus (GLB+)|The GLB+ intervention arm will include participants who did not achieve the targeted percentage of weight loss by week 5, and will add enhanced training to the program that will focus on values clarification, mindful decision making, planning, and problem solving.
15934762|NCT03382860|Diagnostic Test|Fundus videos|Recordings of fundus videos
15934763|NCT03382847|Combination Product|Transplant with HCV positive donor, followed by surveillance and treatment of viremia|Heart transplant with HCV positive donor, followed by treatment for viremia if viremia occurs
15934764|NCT03382834|Drug|Tamoxifen|20 mg orally
15934765|NCT03382834|Drug|Vorinostat|400 mg orally
15934766|NCT03382834|Drug|Antiretroviral drugs|Participants will receive antiretroviral drugs provided by their own doctors. Antiretroviral drugs will not be provided by the study.
15934767|NCT03382821|Procedure|Transforaminal ESI with dexamethasone|Catheter-targeted ESI via interlaminar access at the C7-T1 level with dexamethasone sodium phosphate 1.5 mL (10 mg/mL) and 1 ml 1% lidocaine (total volume 2.5 mL).
15934768|NCT03382821|Procedure|Transforaminal catheter-targeted ESI with triamcinolone|Catheter-targeted ESI via interlaminar access at the C7-T1 level with triamcinolone acetonide 2 mL (40mg/mL) and 1 ml 1% lidocaine (total volume 3 mL).
15934769|NCT03382821|Drug|Dexamethasone Sodium Phosphate 10 MG/ML|Transforaminal ESI with dexamethasone 1.5 mL of dexamethasone sodium phosphate in group #1
15934770|NCT03382821|Drug|Lidocaine|1 mL of 1% lidocaine as diluent for the steroid in both group #1 and group #2
15934771|NCT03382821|Drug|Triamcinolone Acetonide 40mg/mL|Transforaminal catheter-targeted ESI with triamcinolone acetonide 2 mL in group #2
15934772|NCT03382808|Behavioral|SEE Training|Participants are first presented with a fixation cross which indicates the beginning of a trial and is immediately followed by a bilateral presentation of a neutral and a fearful image (face) of the same model identity. The fearful expression is always replaced by an arrow pointing to the left or the right which remaines active until the participant indicates via button-press which direction the arrow is pointing to. The model identity, the position of the fearful cue and the arrow probe direction are pseudo-randomized across trials with no more than three identical sequential occurrences on each parameter. Each session consists of 360 trials in total, with 120 distinct trial types and three repetitions. Participants are trained with neutral and 75% fearful expressions only in the first session; the intensity of the fearful cue is successively decreased by 15% at every subsequent session.
15934773|NCT03382808|Behavioral|GAZE Training|Participants are first presented with a fixation cross, which indicates the beginning of a trial and is immediately followed by a bilateral presentation of a direct gaze-image (neutral face) and an image of a neutral face (same model identity) displaying deviated gaze. The averted gaze-face is always replaced by an arrow pointing to the left or the right which remaines active until the participant indicates via button-press which direction the arrow is pointing to. The model identity, the position of the fearful cue and the arrow probe direction are pseudo-randomized across trials with no more than three identical sequential occurrences on each parameter. Each session consists of 360 trials in total, with 120 distinct trial types and three repetitions. Participants are trained with direct and 100% averted gaze images only in the first session; the intensity of the deviated gaze cue is successively decreased by 20% at every subsequent session.
15934774|NCT03382795|Drug|EGFR|Gefitinib 250mg or Erlotinib 150mg medication, Once-Daily.
15934775|NCT03382782|Behavioral|BWLI|"BWLI includes group weight management classes, physical activity classes, individual sessions with a facilitator to address goals and barriers to weight loss, and weigh-ins.
~A punch card system will be implemented to incentivize participation for BHL classes. Each participant from the BWLI condition will be given a punch card, each punch card contains 10 spaces of punches, and will receive a punch at the end of each class (either BHL or physical activity) they attend. No punch will be given if they are more than 15 minutes late for BHL class or more than 5 minutes late for physical activity class. Participants can earn $5 per punch for up to $250. They will be allowed to cash in for $50 Visa gift card every 10 punches. They cannot cash in for a partially filled card. They must have the 10 full punches to cash in."
15934776|NCT03382782|Behavioral|BWLI & Peer Navigator|Participants receive the BWLI condition and partner with a peer navigator. Peer navigators will meet individually and face-to-face with participants to address their health and weight goals (i.e. working on BWLI homework, attending health care appointments, and facilitating diet and exercise activities). A punch card system will be implemented to incentivize participation for BHL classes. Each participant from BWLI & Peer Navigator will be given a punch card, each punch card contains 10 spaces of punches, and will receive a punch at the end of each class (either BHL or physical activity) they attend. No punch will be given if they are more than 15 minutes late for BHL class or more than 5 minutes late for physical activity class. Participants can earn $5 per punch for up to $250. They will be allowed to cash in for $50 Visa gift card every 10 punches. They cannot cash in for a partially filled card. They must have the 10 full punches to cash in.
15934777|NCT03382782|Behavioral|Integrated Care|Participants receive integrated physical and mental health care from their usual provider.
15934779|NCT03382756|Dietary Supplement|High fat diet|A diet consisting of more than 900kcal and 35% of fat
15934780|NCT03382756|Drug|CKD-337|Test Drug
15934781|NCT03382743|Drug|Endocervical Lidocaine spray|5 sprays of endocervical Lidocaine spray (10%) is used 3 minutes before office hysteroscopy
15934782|NCT03382730|Other|Chlorhexidine Mouth Rinse|Oral chlorhexidine gluconate oral rinse
15934783|NCT03382730|Other|Chlorhexidine Mouth Rinse De-Adoption|Multifaceted education and audit/feedback.
15934784|NCT03382717|Device|Excilor Forte|1 application per day during 6 months
15934785|NCT03382717|Drug|Loceryl 5%|1 application per week during 6 months
15934786|NCT03382704|Diagnostic Test|Examination for presence or absence of lanugo hairs|Pre-operative examination for presence or absence of lanugo hairs
15934787|NCT03382691|Device|blood pressure check|Check blood pressure using new device and conventional device alternatively. Compare blood pressure measured with new device and conventional device.
15934788|NCT03382639|Drug|TAK-831|TAK-831 tablets.
15934789|NCT03382639|Drug|Placebo|TAK-831 placebo-matching tablets.
15934834|NCT03382340|Drug|Imx-110|a nanoparticle encapsulating a Stat3/NF-kB/poly-tyrosine kinase inhibitor and low-dose doxorubicin
15935196|NCT03379428|Drug|Ibrutinib 840 mg|840 mg by mouth daily
15934790|NCT03382626|Device|anodal tDCS|Anodal tDCS will be applied on the left prefrontal cortex dorsolateral (F3 area using International 10-20 system for EEG electrode placement) with the following parameters: electrode size of 25-35 cm², 2mA, 0.057 mA/cm² and duration of 20 minutes. The cathode will be placed over the supra-orbital region.
15934791|NCT03382626|Device|Computer-assisted training|The computer-assisted cognitive training will consist of games with visual and auditory stimuli to improve working memory, attention, and executive function. The games will be Genius and Labyrinth games, reaction time and timing-coincident.
15934792|NCT03382626|Device|sham tDCS|Sham tDCS will be applied with the same parameters and electrode placement of active anodal tDCS. However, the current flow will be interrupted by the device after few seconds.
15934793|NCT03382600|Biological|Pembrolizumab|200 mg Q3W on Day 1 by IV infusion
15934794|NCT03382600|Drug|Oxaliplatin|130 mg/m^2 Q3W on Day 1 by IV infusion
15934795|NCT03382600|Drug|TS-1|40 to 60 mg orally according to Body Surface Area (BSA) BID Q3W on Days 1-14
15934796|NCT03382600|Drug|Cisplatin|60 mg/m^2 Q3W on Day 1 by IV infusion
15934797|NCT03382587|Drug|Aflibercept (Eylea, BAY86-5321)|"Intravitreal aflibercept injections used in a routine treat and extend regimen, under which the intervals between the injections are extended if disease stability is maintained and no signs of worsening disease are observed on the injection day"
15934798|NCT03382574|Biological|Denosumab|Given SC
15934799|NCT03382574|Procedure|Salpingo-Oophorectomy|Undergo risk-reducing salpingo-oophorectomy
15934800|NCT03382561|Drug|Carboplatin|Given IV
15934801|NCT03382561|Drug|Cisplatin|Given IV
15934802|NCT03382561|Drug|Etoposide|Given IV
15934803|NCT03382561|Biological|Nivolumab|Given IV
15934804|NCT03382548|Drug|Reducing Antibiotics treatment duration|Antibiotics should be stopped from day 3 to 7 if respiratory cultures are negative and the patients fulfill a set of stringent clinical criteria signifying cardiopulmonary stability for 48 hours. If the respiratory cultures are positive, patients who fulfill the same set of clinical criteria should have their antibiotics stopped from day 5 to 7.
15934805|NCT03382548|Drug|Standard Antibiotics treatment duration|Participants in the control (long duration) arm will receive standard care, which is antibiotic treatment for at least 8 days with the exact duration decided by the primary physician.
15934806|NCT03382535|Behavioral|Voice therapy|Voice therapy with direct and indirect therapy elements.
15934807|NCT03382535|Behavioral|Voice therapy with carryover strategies|Voice therapy with direct and indirect therapy elements and supplementary tasks and reminders.
15934808|NCT03382535|Other|Control group|No therapy during eight weeks. After the control period half of the group will be provided with Voice therapy and half with Voice therapy with carryover strategies.
15934809|NCT03382509|Drug|[14C]BI 1467335|Once Daily
15934810|NCT03382509|Drug|BI 1467335|Twice Daily
15934811|NCT03382496|Other|Non-Interventional|Non-Interventional
15934812|NCT03382483|Device|Low intensity pulsed ultrasound|bone growth stimulator
15934813|NCT03382470|Other|Antimicrobial stewardship advice|A basic antimicrobial stewardship team will be created at each site. The team will provide advice on the treatment of urinary tract infections and asymptomatic bacteriuria during the second half of the study.
15934814|NCT03382457|Device|Transcatheter Tricuspid Valve Reconstruction|Reconstruction of the tricuspid valve through a transcatheter approach
15934815|NCT03382444|Procedure|Cognitive Assessment|Each patient with have a 2 hour cognitive assessment at baseline, 3months after starting renal replacement therapy and 12 months after starting renal replacement therapy
15934816|NCT03382444|Diagnostic Test|Depression and Quality of Life Assessment|Each patient with have a 2 hour depression and QOL assessment at baseline, 3months after starting renal replacement therapy and 12 months after starting renal replacement therpay
15934817|NCT03382431|Drug|PC786|Repeat doses
15934818|NCT03382431|Drug|Placebo/vehicle|Repeat doses
15934819|NCT03382418|Biological|gp145 C.6980 Vaccine|Administered by intramuscular injection in the deltoid.
15934820|NCT03382418|Biological|Placebo|Sodium Chloride for Injection, 0.9%; Administered by intramuscular injection in the deltoid.
15934821|NCT03382418|Biological|Aluminum Hydroxide Adjuvant|Administered by intramuscular injection in the deltoid.
15934822|NCT03382405|Biological|mRNA-1647|Escalating dose levels
15934823|NCT03382405|Biological|mRNA-1443|Escalating dose levels
15934824|NCT03382405|Other|Placebo|Saline
15934825|NCT03382392|Other|Assesment of REE in ALS patients compared to control populations and to compare six formulas commonly used to predict REE.|
15934826|NCT03382379|Device|Active transcranial Direct Current Stimulation (tDCS)|Transcranial Direct Current Stimulation (tDCS) as a device-based technology is employed by applying a very weak (2 mAmp) direct current over the skull for 1200 seconds with 30 seconds ramp up to 2 mAmp, and 30 seconds ramp down at the end.
15934827|NCT03382379|Device|Sham transcranial Direct Current Stimulation (tDCS)|Sham Transcranial Direct Current Stimulation (tDCS) as a device-based technology is employed by applying a very weak direct current over the skull. Sham mode will have just 30 seconds ramp up to 2 mAmp, 40 seconds on 2 mAmp stimulation and, 30 seconds ramp down with 1160 seconds no stimulation (just impedance control).
15934828|NCT03382366|Diagnostic Test|Blood sampling, risk of fall evaluation, and MR acquisition.|Data will be collected on 1) bone/muscle metabolism through blood sampling, 2) risk of fall through OAK device; 3) muscle quality through MR acquisition.
15934829|NCT03382353|Dietary Supplement|Nutritional supplementation|Daily consumption of Tramiprosate (100 mg) for 1 year
15934830|NCT03382353|Behavioral|Educational training|16 educational lessons (twice a week): basic principles of different cognitive domains (e.g. memory, attention, perception) and educational DVD viewing.
15934831|NCT03382353|Behavioral|Counselling on a brain-healthy diet|4 lessons on the principles of Mediterranean Diet lead by a nutritionist, aimed to teach how to include brain-healthy foods in daily diet (e.g. antioxidant, omega-3 fatty acids and vitamins). Each participant will receive the educational material presented.
15934832|NCT03382353|Behavioral|Physical exercise training|80 sessions of physical exercise supervised by a Fitness Training Expert with the aim of achieving 150 minutes of moderate-intensity physical activity per week
15934929|NCT03381521|Drug|Normal saline|The normal saline was used for injection solution
15935197|NCT03379428|Drug|Ibrutinib 420 mg|420 mg by mouth daily
15934835|NCT03382327|Procedure|Surgical planning|Two surgical plans will be established preoperatively. The first plan will be based on standard preoperative images (CT-scan, MRI) review. The second plan will be based on the 3D model review. Both will be compared to the actual surgery performed in the operating room.
15934836|NCT03382314|Combination Product|HDDO-1614|"Combination drug (Bazedoxifene + Cholecalciferol)
~Incrementally modified drug
~Not market authorized product"
15934837|NCT03382314|Drug|Bazedoxifene / Cholecalciferol|Co- Administration of Bazedoxifene and Cholecalciferol
15934838|NCT03382301|Drug|Ciclosporin A preconditioning before renal artery stenosis dilation|Ciclosporin A perfusion (2.5 mg/kg) for 1 hour before renal artery dilation
15934839|NCT03382301|Drug|NaCl preconditioning before renal artery stenosis dilation|NaCl perfusion (Saline perfusion) for 1 hour (2.5 mg/kg) before renal artery dilation
15934840|NCT03382288|Device|EYESTAR 900|EYESTAR 900 is an optical biometry device used to create a geometrical representation of the eye by means of optical interferometry. The experimental intervention is an optical, non-contact examination with the investigational device EYESTAR 900.
15934841|NCT03382275|Drug|Iron Supplement|any oral or intravenous prescription iron supplement
15934842|NCT03382262|Drug|FX006 32 mg|Extended-release 32 mg FX006 IA injection
15934843|NCT03382262|Drug|TAcs 40 mg|Immediate-release 40mg TAcs IA injection
15934844|NCT03382249|Combination Product|Sonodynamic therapy (SDT)|Sonodynamic therapy(SDT) treatment is the combination of sonosensitizer administration and target atherosclerotic lesions ultrasound exposure. Sinoporphyrin sodium (DVDMS) as sonosensitizer, is dissolved in 0.9% sodium solution for following skin test and intravenous injection. 0.01mg/ml DVDMS solution (0.1ml) is prepared for skin test followed by 0.04 mg/ml DVDMS solution intravenous injection (0.2mg/kg).The target atherosclerotic lesions are marked on the corresponding skin with ultrasound guidance and underwent ultrasound exposure after 4 hours incubation. The therapeutic ultrasonic transducer is fixed to the marked skin site for 15min of each lesion. Ultrasound parameters included intensity of 1.6W/cm2 for carotid lesions, resonance frequency: 1.0 MHz and duty factor: 30%.
15934845|NCT03382249|Combination Product|pseudo-SDT|Pseudo-SDT combines saline injection and obstructed ultrasound exposure on targeted lesions to simulate real SDT progression.
15934846|NCT03382236|Other|osteopathy|osteopathic techniques
15934847|NCT03382210|Other|Enhanced recovery protocol|Standardized enhanced recovery protocol including 21 perioperative items.
15934848|NCT03382197|Device|Nebulization|For inhalation of the radioaerosol a dose of DTPA-Tc99m (methionine-labeled diethylnitriaminepentaacetic acid) with 1mCi activity, associated with 10 drops of Fenoterol Bromide and 20 drops of Ipatropium Bromide diluted for a total of up to 3 ml of saline solution 0.9%. A MESH vibrating nebulizer (NIVO, Philips Respironics, Murrysville, Pennsylvania) will be used.
15934849|NCT03382197|Device|Positive expiratory pressure valve|For nebulization associated with the EPAP valve will be used a non-invasive distribution system consisting of a non-toxic orofacial mask connected to a spring loaded EPAP valve. This mask will be secured to the patient's face through tabs in order to prevent leakage and to maintain proper pressurizing and better patient adaptation.
15934850|NCT03382197|Device|Nonivasive ventilation|For nebulization associated with NIV, a noninvasive distribution system consisting of a non-toxic orofacial mask connected to the NIV circuit will be used, and the latter will be being fed by a radioaerosol flow generated by a nebulizer coupled to the circuit. This mask will be secured to the patient's face through tabs in order to prevent leakage and to maintain proper pressurizing and better patient adaptation.
15934851|NCT03382184|Device|Fraxel Dual laser|The Fraxel DUAL 1550 nm laser will be used at 7 mJ, 8 pulses, 120 spots/cm2, treatment level 3 (9% coverage) for hair regrowth.
15934852|NCT03382184|Device|Halo laser|The Halo hybrid laser will be used per protocol due to its dynamic thermal optimization technology for hair regrowth.
15934853|NCT03382171|Other|FoodforCare at home|Five small protein rich meals that will be delivered twice a week for 3 weeks.
15934854|NCT03382145|Other|No intervention|No intervention
15934855|NCT03382132|Behavioral|momHealth|Mobile health program delivered via an iPad. Program delivers information and support related to breastfeeding education, Ten Steps of the Baby Friendly Hospital Initiative, healthy eating and active living topics, and depression prevention information.
15934856|NCT03382132|Behavioral|Standard of Care|Participants will receive standard health care via their prenatal provider, including routine prenatal education and postpartum support.
15934857|NCT03382119|Device|Ultrasound with ARFI (acoustic radiation force impulse)|This technology uses sound waves to measure the stiffness of tissue.
15934858|NCT03382119|Device|Ultrasound with backscatter imaging|This ultrasound tool gathers data from the waves returning from imaged tissue.
15934859|NCT03382106|Drug|Sildenafil 20 MG|Sildenafil, 20mg three times daily for 3 month period.
15934860|NCT03382106|Drug|Placebo Oral Tablet|Placebo manufactured to look like Sildenafil 20 MG
15934861|NCT03382106|Diagnostic Test|Pulse wave velocity|Vascular pulse measurement at the radial, brachial, femoral, and carotid arteries are taken using a tonometer probe.
15934862|NCT03382106|Diagnostic Test|Carotid artery compliance and stiffness|An echocardiogram is done by using a probe placed on the skin.
15934863|NCT03382106|Diagnostic Test|Pressure wave reflection|Carotid pulse measurement taken using a tonometer probe
15934864|NCT03382093|Behavioral|Personalized Feedback Intervention|Personalized Feedback Intervention for smoking and anxiety.
15934865|NCT03382093|Behavioral|Smoking Information Control|Smoking Information with no personalized feedback.
15934866|NCT03382080|Other|Dream School Program|The Dream School program is a whole school program, involving staff and students, with the aim of creating learning environments where students are confident and experience a sense of belonging, and where mental health is promoted.
15934867|NCT03382080|Other|Mental Health Support Team|"MHST is also a whole school project but aimed at specific students at risk of dropping out. It is a systematisation of the student services through
~Co-location of services and staff working in services
~One open door to increase accessibility to the services and staff for students
~Focus on the transition from lower to upper secondary school
~Close follow-up of students at risk to ensure tailored help to each student
~Early intervention and follow up when students starts being absent from school This work demands cross- and multidisciplinary collaborations within the MHST, between MHST and school leadership, and between lower and upper secondary schools."
15969622|NCT03115099|Drug|Sitagliptin|Administered orally
15934868|NCT03382067|Dietary Supplement|High Epicatechin/ Melissa|Single consumption of a 55g bar of dark chocolate containing: 42.8g Acticoa chocolate + 7.2g caster sugar + 5g Melissa
15934869|NCT03382067|Other|Low Epicatechin/ Oat bran|Single consumption of a 55g bar of white chocolate containing: 50g Lindor chocolate + 5g oat bran
15934870|NCT03382041|Device|Carbon Fiber Implant|A cannulated rod, made of long carbon fiber reinforced polymer, with interlocking holes at its proximal and distal ends. The Nail provides for a slight bend. A Tantalum radiopaque marker along the Nail longitudinal axis provides for its visualization under fluoroscopy. The Nail proximal end is marked by a tantalum marker.
15934871|NCT03382041|Device|Titanium Implant|An intramedullary rod, also known as an intramedullary nail (IM nail) or inter-locking nail or Küntscher nail (without proximal or distal fixation), is a metal rod forced into the medullary cavity of a bone. IM nails have long been used to treat fractures of long bones of the body
15934872|NCT03382015|Other|BKR-013 or Placebo|Encapsulated L-glutamine
15934873|NCT03382002|Diagnostic Test|TCL|evaluation of oxidative status
15934874|NCT03381989|Device|ASHI_INTECC Astato XS 20 0.014 guidewire|A coaxial traversal guiding catheter system (typically tandem catheters) directs electrosurgery devices (typically a rigid 0.014 guidewire inside a polymer jacket wire convertor) against the base of the coronary cusp targeted for laceration, using fluoroscopic and/or echocardiographic guidance. Traversal is accomplished by transcatheter electrosurgery by connecting the back end of the 0.014 guidewire to an electrosurgery pencil during short bursts of pure, cutting radiofrequency energy at ap-proximately 30W. The guidewire is repositioned as needed until it crosses the aortic leaflet and is snare-retrieved and externalized. Laceration is performed by positioning the laceration surface along the intended leaflet base, and applying tension on both free ends of the guidewire while simultaneously apply electrosurgery energy (typically 70W) in short bursts, until the laceration is complete and the guidewire is free.
15934875|NCT03381976|Other|Intervention 2X/week (G2X)|Participants performed resistance training (RT) composed of eight exercises performed for one set of 10-15 repetition maximum (RM). The rest interval between exercises was 2-3 min. Participants were instructed to control the speed of movement in the ratio of 1:2 for concentric and eccentric muscle actions, respectively. The progression of training loads in each exercise occurred, when a participant completed 15 repetitions in two consecutive sessions, with increases of 2-5% in exercises for the upper limbs, and 5-10% in exercises for the lower limbs. At the end of each session, one static stretching exercise at the point of discomfort for 15 seconds was performed for all major muscle groups for a total of exercises. Participants were asked not to perform any other type of organized physical exercise during the entire study period.
15934876|NCT03381976|Other|Intervention 3X/week (G3X)|Participants performed resistance training (RT) composed of eight exercises performed for one set of 10-15 repetition maximum (RM). The rest interval between exercises was 2-3 min. Participants were instructed to control the speed of movement in the ratio of 1:2 for concentric and eccentric muscle actions, respectively. The progression of training loads in each exercise occurred, when a participant completed 15 repetitions in two consecutive sessions, with increases of 2-5% in exercises for the upper limbs, and 5-10% in exercises for the lower limbs. At the end of each session, one static stretching exercise at the point of discomfort for 15 seconds was performed for all major muscle groups for a total of exercises. Participants were asked not to perform any other type of organized physical exercise during the entire study period.
15934877|NCT03381937|Other|speech trial|speech trial during different ventilation conditions
15934878|NCT03381924|Other|Educational programme|In each session, neuroscience-based information on the neurophysiology of pain and migraine were provided with audio-visual support.
15934879|NCT03381924|Other|Routine clinical practice|Patients allocated to the control group will only receive the drugs used in the habitual clinical practice
15934880|NCT03381911|Other|Embodied Conversational Agent|The Embodied Conversational Agent (ECA) is a computer generated character that can interact with study subjects through a touch screen computer. The ECA is programmed to respond with relevant speech and body language to a subject's responses.
15934881|NCT03381898|Behavioral|Telehealth Exercise, speech therapy, medication management|Telehealth exercise once per week, speech therapy 4 times per week, medication management once per week
15934882|NCT03381885|Behavioral|Gentle Nudge|Clinicians ordering medium or high scoring imaging studies could bypass the usual mandatory phone call to radiology.
15934883|NCT03381885|Behavioral|Usual Standard Procedure|Clinicians ordering imaging studies required mandatory phone to radiology
15934884|NCT03381872|Procedure|Percutaneous coronary intervention for complex lesion|"In patients who have complex coronary lesions, PCI will performed using intravascular imaging or angiography only according to the allocated arms
~Intravascular imaging arm
~Angiography arm
~Definition of Complex Lesions
~True bifurcation lesion (Medina 1,1,1/1,0,1/0,1,1) with side branch ≥2.5mm size
~Chronic total occlusion (≥3 months) as target lesion
~PCI for unprotected left main (LM) disease (LM os, body, distal LM bifurcation including non-true bifurcation)
~Implanted stent length ≥38mm
~Multi-vessel PCI (≥2 major epicardial coronary arteries treated at one PCI session)
~Multiple stent needed (≥3 more stent per patient)
~In-stent restenosis lesion as target lesion
~Severely calcified lesion (encircling calcium in angiography)"
15934885|NCT03381872|Device|Drug-eluting stent|All patient will be received percutaneous coronary intervention with second generation drug-eluting stent.
15934886|NCT03381872|Device|Intravascular imaging (IVUS or OCT)|"IVUS Reference site: Largest lumen, Plaque burden <50% Stent sizing: By measuring vessel diameter (external elastic membrane) at proximal and distal reference sites. The averaged value of the proximal and distal reference external elastic membrane diameter will be used as stent diameter
~OCT Reference site: Most normal looking segment, No Lipidic plaque Stent sizing: [1] By measuring vessel diameter at the distal reference sites (in case of ≥180 of the external elastic membrane can be identified). In this case, stent diameter will be determined using mean lumen diameter at the distal reference, rounded up to the nearest 0.25mm [2] By measuring lumen diameter at the distal reference sites (in case of ≥180° of the external elastic membrane cannot be identified). In this case, stent diameter will be determined using mean external elastic membrane diameter at the distal reference, rounded down to the nearest 0.25mm."
15934887|NCT03381859|Drug|Elbasvir/Grazoprevir 50 MG-100 MG Oral Tablet [ZEPATIER]|Hepatitis C Virus direct-acting antiviral
15934888|NCT03381846|Procedure|MOHS micrographic surgery|Mohs surgery is a precise surgical technique used to treat skin cancer. Thin layers of cancer-containing skin are progressively removed and examined microscopically until only cancer-free tissue remains.
15934889|NCT03381846|Procedure|Wide local excision|A surgical technique in which the skin cancer is excised along with 2-3 cm of clinically normal appearing surrounding tissue.
15934890|NCT03381833|Drug|LJPC-401|subcutaneous injection, up to 20 mg per week from week 26 to 52
15934891|NCT03381833|Drug|LJPC-401|subcutaneous injection, up to 20 mg per week from week 1 to 52
15934892|NCT03381820|Other|instrumental folk music|The music was composed and edited by a professor of Folk Musical Department, Faculty of Arts, Khon Kaen University. There were total of 6 songs, 32-minute length. The music was slow-instrumental, 60-80 beats per minute and ranged between 40-60 decibel levels.
15934893|NCT03381807|Biological|hAESCs|5*10^7 hAESCs is infused into uterine cavity with TCRA on Day0, Day7 and after the first menstruation
15934894|NCT03381794|Procedure|Corneal transplantation|PKP: Penetrating Keratoplasty DALK: Deep Anterior Lamellar Keratoplasty DMEK: Descemet Membrane Endothelial Keratoplasty DSAEK: Descemet's Stripping Automated Endothelial Keratoplasty
15934895|NCT03381781|Drug|Decitabine|20mg/m^2,d1-5,ivgtt,28days as a duration
15934896|NCT03381781|Drug|Arsenic Trioxide|0.16mg/kg,d1-5,ivgtt,28days as a duration
15934897|NCT03381781|Drug|Cytarabine|15mg/m^2,hypodermic injection,q12h,d1-7
15934898|NCT03381768|Biological|PD-L2 peptide|100 ug PD-L2 peptide dissolved in DMSO and water mixed with 500ul montanide.
15934899|NCT03381768|Biological|PD-L2 and PD-L1 peptide|100 ug PD-L2 peptide and 100ug PD-L1 peptide dissolved in DMSO and water mixed with 500ul montanide.
15934900|NCT03381755|Drug|half-dose ticagrelor|To observe the effectiveness and safety of ticagrelor 45mg bidpo. in Chinese ACS patients undergoing PCI.
15934901|NCT03381755|Drug|standard-dose ticagrelor|To observe the effectiveness and safety of ticagrelor 90mg bidpo. in Chinese ACS patients undergoing PCI.
15934902|NCT03381742|Drug|Ticagrelor|ticagrelor 45 mg twice daily for 5 consecutive days at least.
15934903|NCT03381742|Drug|ticagrelor|ticagrelor 90 mg once daily for 5 consecutive days at least.
15934904|NCT03381742|Drug|ticagrelor|ticagrelor 90 mg twice daily for 5 consecutive days at least.
15934905|NCT03381742|Drug|clopidogrel|clopidogrel 75 mg once daily for 5 consecutive days at least.
15934906|NCT03381729|Biological|Onasemnogene Abeparvovec-xioi|Self-complementary AAV9 carrying the SMN gene under the control of a hybrid CMV enhancer/chicken-β-actin promoter
15934907|NCT03381716|Drug|drug|Application bracket
15934908|NCT03381716|Procedure|Surgery|Surgery
15934909|NCT03381703|Drug|YH12852|YH12852 administration
15934910|NCT03381703|Drug|14C-labeled YH12852|14C-labeled YH12852 administration
15934911|NCT03381690|Procedure|Epidural labor analgesia|Epidural catheter was inserted for labor analgesia using an 18-gauge Tuohy needle and a 20 gauge epidural catheter. In our institute, for epidural labor analgesia, 10 ml bolus of 0.075% levobupivacaine mixed with fentanyl 2 μg/ml was administered and same regimen was continuously infused by patient-controlled epidural analgesia (infusion rate : 10 ml/hr, bolus : 4 ml, lockout time: 30 min).
15934912|NCT03381677|Device|Pedicle Lengthening Osteotomy with Altum® Device|Decompressive surgery via Pedicle lengthening osteotomy using Altum Device. Altum is intended for pedicle lengthening to correct degenerative lumbar spinal stenosis in the presence of a grade 1 degenerative spondylolisthesis. The Altum bone saw is designed for creating an osteotomy at the base of each pedicle. The Altum implant is designed for distraction of the pedicle osteotomy and for lengthening of the pedicles. Altum is appropriate for skeletally mature adults with symptomatic stenosis at one or two levels between L2-L5.
15934913|NCT03381677|Device|Control|"Decompressive surgery via open surgical decompression and Transforaminal Lumbar Interbody Fusion (TLIF) using either a midline or paramedian incision with implantation of bilateral pedicle screws (4 screws) and rods (2 rods) and an interbody fusion cage (1 PEEK fusion cage, coated or uncoated):
~DePuy Synthes Expedium® 5.5 System, Stryker Xia 5.5 System, Medtronic CD Horizon Solera 5.5 Systemor Innovative Surgical Designs True Spinal Fixation System; and
~DePuy Synthes Concord TLIF cage, Stryker UniLIF TLIF cage, Medtronic Capstone TLIF cage or Meditech Talos TLIF cage."
15934914|NCT03381664|Drug|AVP-923|capsule
15934915|NCT03381651|Radiation|Higher dose (50.4Gy/28F) of neoadjuvant chemoradiation|50.4Gy/28F radiation and concurrent chemotherapy with paclitaxel plus CBP used weekly
15934916|NCT03381651|Radiation|Lower dose (41.4Gy/23F) of neoadjuvant chemoradiation|41.4Gy/23F radiation and concurrent chemotherapy with paclitaxel plus CBP used weekly
15934917|NCT03381638|Device|Blink Reflexometer|The device uses 5 light puffs of air to the side of the eye causing a blink reflex that is captured by the high-speed camera tracking the eyelids.
15934918|NCT03381625|Drug|BMX-010|Safety and efficacy of BMX-010 in topical treatment of psoriasis and/or atopic dermatitis.
15934919|NCT03381625|Drug|Placebo|Topical administration of placebo in patients with psoriasis and/or atopic dermatitis.
15934920|NCT03381599|Drug|Filgrastim Injection|Filgrastim of 10 ug/kg/day will be given for four serial days.
15934921|NCT03381586|Drug|ALT-803|Subjects randomized to Group A (n=8) will receive ALT-803 at a concentration of 1.0 mg/mL and subjects randomized to Group B (n=8) will receive ALT-803 at a concentration of 2.0 mg/mL. Subjects will receive a single 10 µg/kg subQ dose of ALT-803 on Day 1 of study period 1. After a rest period, subjects will receive a single 20 µg/kg subQ dose of ALT-803 on Day 1 of study period 2.
15934922|NCT03381573|Drug|Roflumilast|Roflumilast
15934923|NCT03381547|Biological|Pegilodecakin|Pegilodecakin Alone
15934924|NCT03381534|Device|stenting with EPD|participants will be randomly assigned to control group or experimental group,patients in control group will be undergone stenting of vertebral artery origin without embolic protection device,patient in experimental group will be undergone stenting of vertebral artery origin with embolic protection device
15934925|NCT03381534|Device|stent assisted angioplasty|participants will be randomly assigned to control group or experimental group,patients in control group will be undergone stenting of vertebral artery origin without embolic protection device,patient in experimental group will be undergone stenting of vertebral artery origin with embolic protection device
15934926|NCT03381521|Procedure|Ultrasound-guided nerve hydrodissection|Ultrasound-guided nerve hydrodissection with 10cc normal saline between carpal tunnel and median nerve.
15934927|NCT03381521|Procedure|Ultrasound-guided nerve hydrodissection|Ultrasound-guided nerve hydrodissection with 5cc normal saline between carpal tunnel and median nerve.
15934928|NCT03381521|Device|Ultrasound|The ultrasound was used to measure cross-sectional area and injection guidance
15934930|NCT03381508|Device|Brizzy continuous positive pressure device|Patients are treated with the Brizzy continuous positive pressure device, including pneumotachograph.
15934931|NCT03381495|Drug|Ropivacaine Hydrochloride, Sufentanil|In this research one group will receive epidural analgesia(Ropivacaine Hydrochloride, Sufentanil), data will be collected and analyzed between this group and non-epidural analgesia group.
15934932|NCT03381482|Diagnostic Test|CSF drawing during spinal anaesthesia|4mL of CSF by lumbar puncture
15934933|NCT03381482|Diagnostic Test|Fasting blood sample|6x5 mL of fasting blood sample
15934934|NCT03381482|Diagnostic Test|Lumbar puncture|10 mL of CSF by lumbar puncture
15934935|NCT03381469|Procedure|Comprehensive periodontal treatment|The Case group participants will receive non-surgical periodontal therapy that will be completed by the end of week 20-21 of gestation. This will consist of oral hygiene instruction with comprehensive periodontal treatment which will include excavation and sealing of cavities, removal of overhanging restorations, extraction of hopeless teeth followed by supragingival and subgingival scaling and root planing (SRP) of sites with PDs > 4 mm and polishing of all the teeth. Participants will be offered treatment under local anesthetic when necessary. No limits will be imposed on the number of dental visits needed to accomplish periodontal therapy.
15934936|NCT03381469|Procedure|single visit supragingival scaling|The control and Placebo group participants will receive oral hygiene instruction and supragingival cleaning of all teeth at their baseline visit.
15934937|NCT03381456|Other|LICI|Paired pulse TMS to measure LICI and late cortical disinhibition
15934938|NCT03381443|Other|different assessments|coded survey about NTS and assessment
15934939|NCT03381430|Drug|Gefitinib|Gefitinib 250 mg/day oral daily
15934940|NCT03381417|Drug|pegcyte|Eligible patients are scheduled to receive three cycles of chemotherapy every two weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
15934941|NCT03381417|Drug|Neulastim|Eligible patients are scheduled to receive three cycles of chemotherapy every two weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
15934942|NCT03381404|Drug|[14C] MT-8554|14-C MT-8554
15934943|NCT03381391|Behavioral|Personalized Feedback Intervention|The current intervention included personalized feedback regarding their alcohol consumption, alcohol-related consequences, gender-specific normative drinking comparisons, personal risk factors (e.g., dependence symptoms, family history of alcoholism), and alcohol expectancies. The intervention also included didactic material related to alcohol (e.g., effects at different BAC levels, tolerance) and drinking moderation strategies. The feedback was presented graphically in a feedback report with the individual's information.
15934944|NCT03381365|Device|CuraSeal Percutaneous Intraluminal Closure System|
15934945|NCT03381352|Radiation|Chemo-radiotherapy with IMRT technique|IMRT radiation technique; 50.4-54Gy/25F
15934946|NCT03381352|Drug|Capecitabine|Capecitabine 825mg/m2 PO BID
15934947|NCT03381352|Drug|Mitomycin C|Mitomycin C 10mg/m2 D1,29 iv
15934948|NCT03381339|Device|Oscillating rotating power toothbrush|a battery powered oscillating rotating toothbrush will be used for twice daily regular home dental hygiene
15934949|NCT03381326|Procedure|blood and FFPE sample collection|blood sample and Formalin-fixed paraffin-embedded (FFPE) sample collection
15934950|NCT03381313|Behavioral|Conditioned word repetition training|In the classical conditioning training the onset of the visual stimulus preceded that of the auditory stimulus with a short onset asynchrony, and both stimuli co-terminated. By contrast, in the training without conditioning the auditory stimulus was administered first and the visual stimulus appeared short after the off-set of the auditory one.
15934951|NCT03381300|Procedure|Ovarian tissue cryopreservation|Laparoscopic unilateral oophorectomy followed by cryopreservation of ovarian cortex tissue
15934952|NCT03381287|Drug|HTD1801 Tablets, 500mg|16 participants will be randomized 3:1 to receive 500mg of either HTD1801 or placebo, bid. The treatment duration will be 4 weeks.
15934953|NCT03381287|Drug|HTD1801 Tablets, 1000mg|16 participants will be randomized 3:1 to receive 1000mg tablets of either HTD1801 or placebo, bid. The treatment duration will be 4 weeks.
15934954|NCT03381287|Drug|HTD1801 Tablets, 2000mg|16 participants will be randomized 3:1 to receive 2000mg of either HTD1801 or placebo, bid. The treatment duration will be 4 weeks.
15934958|NCT03381261|Drug|Botulinum toxin type A|Injection of Botulinum toxin type A in back of head
15934959|NCT03381248|Device|Cooled Radiofrequency|Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
15934960|NCT03381248|Biological|Hyaluronic Acid|Delivery of hyaluronic acid into knee by injection with needle to reduce knee pain
15934961|NCT03381235|Other|Spin exercise|Each exercise class will consist of 20 minutes of progressive, interval based Spin exercise 2 times a week for 6 months on stationary exercise cycles and will be led by a qualified instructor. The Duration of each session is lengthened based on the progression of the participant and the recommendation of the instructor by 1-2 minutes as needed to a maximum time of 60 minutes per session. Exercise intensity will begin at low levels (50% of maximal heart rate reserve (HRR) and increase by 5% every week (if deemed necessary by the instructor) to a maximum of 75% maximal HRR.
15934962|NCT03381222|Diagnostic Test|epiaoryic scan|Epiaortic scan will be performed by use L15-7i Phillips®. Ultrasound probe cover with sterile cover. Five standard epiaortic views will be collected
15934963|NCT03381209|Drug|Sugammadex|sugammadex given based on 3 measurements of body weights
15934964|NCT03381196|Drug|Pimodivir 600 mg|Participants will receive pimodivir 600 mg, orally, twice daily, for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of pimodivir on Day 1 [evening], dosing will continue until the morning of Day 6).
15934965|NCT03381196|Drug|Placebo|Participants will receive placebo matching to pimodivir, orally twice daily for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of placebo on Day 1 [evening], dosing will continue until the morning of Day 6).
15935035|NCT03380624|Drug|Refresh Optive|Lubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose
15934966|NCT03381196|Other|SOC Treatment|Participants may receive SOC treatment as a part of background therapy. The SOC treatment is determined by the investigator based on local practice, and may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of the SOC should be made before randomization. The influenza antiviral should be started no later than Day 2 morning (up to noon).
15934967|NCT03381183|Drug|Durvalumab|Phase 1 and Phase 2: 1500 mg every 4 weeks (Q4wks).
15934968|NCT03381183|Drug|IRX-2 Regimen|"Phase 1 and Phase 2 - Every 12 weeks - IRX-2 Regimen:
~Cyclophosphamide 300 mg/m^2 - intravenously.
~IRX-2: 460 units daily (4 injections of 115 units)."
15934969|NCT03381170|Biological|Ublituximab|Enrolled Subjects will be infused with ublituximab on Weeks 1E, 24E, 48E, 72E and 96E
15934970|NCT03381157|Other|Observational General Movements Assessments|GMs assessment has been increasingly used to predict motor dysfunction, especially the Cerebral Palsy (SP), since its introduction 25 years ago. The GMs assessment is based on the visual holistic perception of normal and abnormal movements of the body. This approach focuses on spontaneous movements of the baby rather than reflexes, tonus, and reactions
15934971|NCT03381144|Drug|GDC-0334|Part 1: GDC-0334 given orally with dose escalation between cohorts, based on emerging safety and pharmacokinetic (PK) data. Parts 2 and 3: doses to be based on the safety, tolerability, and PK data generated in the study. The dosing duration in Part 3 is planned to be at least 14 days, but no longer than 28 days.
15934972|NCT03381144|Drug|Placebo|Participants will receive GDC-0334-matching placebo.
15934973|NCT03381118|Drug|Cytarabine|Cytarabine 500-1000 mg/m2 bid IV infusion on D-4, -3, -2
15934974|NCT03381118|Drug|Nivolumab|Nivolumab 40 mg IV infusion on D+5
15934975|NCT03381118|Drug|Cytarabine|Cytarabine 500-1000 mg/m2 bid IV infusion on D+1, +2, +3
15934976|NCT03381118|Drug|Nivolumab|Nivolumab 40 mg IV infusion on D+1
15934977|NCT03381118|Biological|G-CSF mobilized HLA-haploidentical donor PBSC|G-CSF mobilized HLA-haploidentical donor peripheral blood stem cells IV infusion on D0
15934978|NCT03381105|Diagnostic Test|PSA and Stockholm3|The new Stockholm3 test and traditional PSA test
15934979|NCT03381079|Procedure|Posterior scleral reinforcement|Posterior scleral reinforcement (pPSR) is a procedure applied with autologous or biological material or synthetic materials reinforcing pole of the sclera after eyeball, in order to prevent or alleviate myopic development.
15934980|NCT03381066|Drug|gefitinib, pemetrexed,cisplatin|"Intercalation phase (Duration: 3weeks x 4 cycles = 12 weeks) Pemetrexed 500mg/m2 D1, Cisplatin 75mg/m2 D1, Gefitinib 250mg D5-18, every 3week
~Maintenance phase (Duration: 1 year) Gefitinib 250mg D1-2"
15934981|NCT03381066|Drug|Vinorelbine, cisplatin|Duration: 3wks x 4 cycles = 12 weeks Vinorelbine 25mg/m2 D1,8, Cisplatin 75mg/m2 D1 q3week
15934982|NCT03381053|Drug|Imatinib 400mg|The NIH assessment of patients with surgical excision of GIST with moderate to high risk of recurrence was recommended imatinib 400mg treatment.
15934983|NCT03381040|Device|Restylane Lyft|Restylane® Lyft is a sterile gel of hyaluronic acid with lidocaine generated by Streptococcus species of bacteria, chemically cross-linked with BDDE (the cross linker), stabilized and suspended in phosphate buffered saline at pH=7 and concentration of 20 mg/mL. Lyft is intended to be used for facial tissue augmentation. It is recommended that the product be used for shaping the contours of the face and the correction of folds using the co-packed needles. Given the very high lift capacity of Lyft, it is often used when the skin envelope is normal or thicker than normal, as the contours of the product may be palpable in the presence of thin skin.
15934984|NCT03381040|Device|Restylane Volyme|"Restylane® Volyme is a sterile, biodegradable, viscoelastic, non-pyrogenic, clear, colorless, and homogeneous soft hyaluronic acid gel with a high lifting capacity. Volyme is intended for injection into the supraperiostic zone or subcutis to augment the volume of the cheeks.
~Given Volyme's viscoelastic and lifting capacities, it is best used when there is significant loss of volume and a thin skin envelope."
15934985|NCT03381027|Procedure|Baby Massage|Structured massage of the baby
15934986|NCT03381014|Drug|Chemotherapy, Cancer, Anthracyclines|follow up cardio-toxicity .... by speckle tracking echo and cardiac troponin
15934987|NCT03381001|Procedure|embryo transfer after thaw and culture|embryos will be kept in culture after thawing for one day before transfer for the uterus
15934988|NCT03381001|Procedure|embryo transfer with no culture|embryos will be transfer with no culture after thaw
15934989|NCT03380988|Other|Acute test meal with fiber-enriched buckwheat pasta|Pasta with tomato sauce (100g tomato sauce, 5g extra-virgin olive oil)
15934990|NCT03380988|Other|Acute test meal with corn pasta|Pasta with tomato sauce (100g tomato sauce, 5g extra-virgin olive oil)
15934991|NCT03380975|Drug|Montelukast 10mg|Montelukast is an orally active compound which binds with high affinity and selectivity to the CysLT1 receptor. Montelukast inhibits physiologic actions of LTD4 at the CysLT1 receptor without any agonist activity. As a result, bronchoconstriction is inhibited with decreased airway and blood eosinophil's leading to improved control over asthma and allergic rhinitis. Montelukast should be taken once daily in the evening
15934992|NCT03380962|Drug|Clazakizumab|All patients will receive clazakizumab 25 mg subcutaneous injections (monthly) for a maximum of 18 injections.
15934993|NCT03380949|Procedure|Opioid administration (remifentanil) in intervention group|Elective surgery in radical open abdominal prostatectomy. Opioid titration (remifentanil) is guided by analgesia indices during general anesthesia in the experimental arms.
15934994|NCT03380949|Procedure|Opioid administration (remifentanil) in control group|Elective surgery in radical open abdominal prostatectomy. Opioid titration (remifentanil) is guided by clinical signs in the control group.
15934995|NCT03380936|Drug|Tacrolimus Extended Release Oral Tablet [Envarsus]|Switching from current version of tacrolimus to the extended release, once a day version (Envarsus) and titrating dose to achieve an optimal trough level. Goal trough tac level > 8 ng/ml, MPA at 720 mg bid unless medically contraindicated, prednisone at current dose (5mg) or continue taper to 5mg per center standard of care protocol.
15934996|NCT03380936|Other|Plasma Exchange and IVIG (Intravenous Immunoglobulin )|Plasma exchange x 5 treatments, each followed by IVIG 200 mg/kg except last dose of 1 gm/kg. Rituximab 375 mg/m2 following final plasma exchange treatment.
15934997|NCT03380923|Behavioral|Moderate Intensity|Exercise prescription intensity is moderate
15934998|NCT03380923|Behavioral|High Intensity|Exercise prescription intensity is high
15935073|NCT03380416|Other|MUFA Diet|Medium-term (8 weeks ) nutritional intervention used as control
15934999|NCT03380910|Behavioral|Pharmacy and Behavioral Health Team|An interdisciplinary approach using medications through pharmacy support and counseling through behavioral health team members will be used to improve smoking cessation rates.
15935000|NCT03380910|Behavioral|Motivational Interviewing|Patients not ready to quit will be offered motivational interviewing to increase readiness to quit.
15935001|NCT03380897|Other|Intervention for outpatient group was to go home|Intervention for outpatient group was to go home and assess the the pain
15935002|NCT03380897|Other|Intervention for inpatient group was to stay at ward|Intervention for inpatient group was to stay at ward and assess the pain
15935003|NCT03380884|Device|Low-magnitude high-frequency vibration (LMHFV)|Low-magnitude high-frequency vibration (LMHFV) is a biophysical intervention that provides non-invasive, systemic mechanical stimulation and has been reported to have no adverse effect.
15935004|NCT03380871|Biological|NEO-PV-01|Personal Cancer Vaccine
15935005|NCT03380871|Biological|Pembrolizumab|monoclonal antibody against PDL1
15935006|NCT03380871|Other|Adjuvant|immune adjuvant
15935007|NCT03380871|Drug|Carboplatin|chemotherapy
15935008|NCT03380871|Drug|Pemetrexed|chemotherapy
15935009|NCT03380858|Device|colectomy|colectomy resection
15935010|NCT03380845|Device|Fraxel Restore|Non-ablative Laser. In the study, one side of the face will be treated with Fraxel Restore monthly for three months.
15935011|NCT03380845|Device|Fractora|Fractional Radiofrequency Microneedling Device. In the study, one side of the face will be treated with Fractora monthly for three months.
15935012|NCT03380819|Diagnostic Test|Genome sequencing|Patients will undergo exome or genome sequencing, and their referring provider will receive an interpreted report with the following categories of results: 1) results related to the indication for testing, 2) secondary monogenic results, 3) carrier status, 4) pharmacogenomics results.
15935013|NCT03380806|Drug|LHRH agonist|Standard LHRH agonist for 3 years
15935014|NCT03380806|Radiation|Pelvic Radiation|Pelvic Radiation
15935015|NCT03380806|Radiation|Stereotactic Body Radiotherapy (SBRT)|SBRT: 19.5 - 21 Gy in three fractions (1 treatment per week - over 22days)
15935016|NCT03380806|Radiation|Conventional Radiotherapy (CRT) Prostate Boost|CRT: 33 - 35 Gy in 16 fractions (5 days per week - over 22 days)
15935017|NCT03380793|Drug|morinidazole|morinidazole and sodium chloride injection (500 mg intravenous, twice daily for 5-7 days) with aztreonam and (or) etimicin.
15935018|NCT03380780|Drug|Emicizumab|Participants will receive a single 1 milligram per kilogram of body weight (mg/kg) subcutaneous dose of emicizumab on Day 1.
15935019|NCT03380767|Procedure|Trauma-induced coagulopathy treatment|Transfusion as needed according to the assay methodology
15935020|NCT03380754|Dietary Supplement|Nutricia preOp|A clear, non-carbonated lemon-flavored, iso-osmolar carbohydrate drink for preoperative surgical patients. Used in studies supporting the Enhanced Recovery After Surgery (ERAS) Society Consensus Guidelines.
15935021|NCT03380754|Other|Nestle Splash Lemon Flavor Water (Placebo)|Placebo control drink. PURIFIED WATER, NATURAL FLAVORS, CITRIC ACID, SODIUM POLYPHOSPHATE, POTASSIUM SORBATE (PRESERVE FRESHNESS), POTASSIUM BENZOATE (PRESERVE FRESHNESS), SUCRALOSE, ACESULFAME POTASSIUM, CALCIUM DISODIUM EDTA, MAGNESIUM SULFATE.
15935022|NCT03380741|Diagnostic Test|Tumour markers detection|Lab on a chip detection of tumour markers measured from vaginal/cervical cytology swab
15935023|NCT03380728|Drug|Ibogaine Hydrochloride|The first 3 patients will receive oral doses of 20 to 400 mg of ibogaine in an open-label design. If the 3 higher doses (240, 320 and 400 mg) are well tolerated, the next 9 volunteers will receive these doses or placebo randomly in 3 different groups.
15935024|NCT03380715|Device|Nasal nebulisation into the right nostril|400mcl of co-phenylcaine (20mg of lidocaine + 2mg of phenylephrine) is added into the nasal nebuliser device (Rinowash Nebula, Air liquid medical systems) and the solution is diluted with 4.5cc of isotonic normal saline. This Mixture is then nebulised into the right nasal cavity for approximately 3 minutes.The seated patient's head is kept flexed and nebulizer device is kept sealed within the nasal cavity while the nebulisation is done and subsequently checking nasal resistance after nasal nebulisation.
15935025|NCT03380715|Device|Nasal Spray into the right nostril|Intervention : Administration of 4 sprays of nasal decongestions(Co-Phenylcaine(400mcl) (20mg lidocaine + 2mg phenylephrine) once into the right nasal cavity using a nasal spray and subsequently checking nasal resistance post nasal spray
15935026|NCT03380702|Procedure|whitening photoactivation gel|35 subjects in active comparator group
15935027|NCT03380702|Procedure|placebo|35 subjects in placebo comparator group
15935028|NCT03380689|Drug|S-1|- S-1 is administered orally on days 1 to 7 of a 14-day cycle. Patients are assigned on the basis of body surface area (BSA) to receive one of the following oral doses twice daily: 40 mg (BSA <1.25m2), 50 mg (BSA >1.25 to <1.50 m2), or 60 mg (BSA >1.50 m2).
15935029|NCT03380689|Drug|Irinotecan|- CPT-11 was administrated as a 90-min intravenous infusion on day 1 of a 14-day cycle. Five escalating dose levels of CPT-11 were prepared, at an initial dose of 75mg/m2/day (level 1), stepping up to 100 (level 2), 125 (level 3), 150 (level 4) or 175 (level 5) mg/m2/day.
15935030|NCT03380689|Drug|Bevacizumab|- Bevacizumab (5 mg/kg) is administered by intravenous infusion over the course of 30 to 90 min on day 1 of each 2-week cycle.
15935031|NCT03380663|Procedure|Remote Ischemic Conditioning (RIC)|"Remote Ischemic Conditioning (RIC) is a new treatment modality to attenuate reperfusion injury. Organ protection by RIC can be achieved simply by inducing 3 or 4 five-minute cycles of limb ischemia and reperfusion using a tourniquet or simple blood pressure cuff Ischemic resistance exercise training conducted as low-intensity blood flow restricted resistance exercise (BFRE), with a low occlusion pressure stimulus, which only compromises venous but not arterial blood flow. Much like RIC, BFRE is conducted as 3-5 cycles (sets of exercise) interspaced by short duration of recovery.
~High intensity traditional resistance training (TRT) is performed by sets of 10-12 repetitions are performed in the knee extensor machine - load equaling 15RM and rest for 3 minutes)."
15935032|NCT03380650|Device|directional atherectomy and locol drug delivery|combined use of directional atherectomy and locol drug delivery for the treatment of femoralpopliteal disease
15935033|NCT03380650|Device|drug-coated balloon dilation|use of drug-coated balloon dilation for the treatment of femoralpopliteal disease
15935034|NCT03380637|Other|ultrasound|Sonosite ultrasound (Sonosite, FUJIFILM M-Turbo, made in USA)
15935074|NCT03380403|Radiation|PDT|clinical treatment of infected diabetic foot
15935036|NCT03380624|Drug|Refresh Optive MEGA-3|Lubricate and hydrating relief of eye dryness investigational lubricant eye drop is based on carboxymethylcellulose and with flaxseed oil and trehalose
15935037|NCT03380611|Dietary Supplement|Wakame|Consumption of 4.8 grams wakame per day for 17 days
15935038|NCT03380611|Dietary Supplement|Spirulina|Consumption of 4.8 grams spirulina per day for 17 days
15935039|NCT03380611|Dietary Supplement|Control|Consumption of microcrystalline cellulose for 17 days
15935040|NCT03380598|Behavioral|CLOSS|Usual care plus using mobile application's to register weight and physical activity as well as for communication with the clinic. A web-based system enables health care professionals to follow the the patient's daily weight registration online.
15935041|NCT03380598|Behavioral|Usual care|Usual care. The child and parent(s) at regular visits to the nurse at the clinic
15935042|NCT03380585|Procedure|Reciprocating single-file system|After determining the working length, a flexible size 30 K-file will be inserted 1 mm beyond the WL and the apical foramen will be enlarged.The device in the experimental group moves in CW and CCW direction with different angles. It is a single-file endodontic file system. The intervention is reciprocating single-file system. A Reciproc single-file will be used for enlarging apical foramen. In the active comparator group, a continuous rotational multi-file system, ProTaper Next, will be used in enlarging apical foramen.
15935043|NCT03380585|Procedure|Rotational multi-file system.|After determining the working length, a flexible size 30 K-file will be inserted 1 mm beyond the WL and the apical foramen will be enlarged. In this group, a continuous rotational multi-file system, ProTaper Next, will be used in enlarging apical foramen.
15935044|NCT03380572|Device|Senhance Assisted Cholecystectomy|Cholecystectomy performed using Senhance surgical robotic system
15935045|NCT03380572|Procedure|Laparoscopic Cholecystectomy|Standard laparoscopic cholecystectomy
15935046|NCT03380559|Drug|Injection, botulinum toxin + corticoid|"Intramuscular injection of botulinum toxin (Xeomin® 50 U) under ultrasound control
~Subcutaneous injection (lateral epicondylitis side) of corticoid (2 ml of Hydrocortancyl® 2,5 %)"
15935047|NCT03380559|Drug|Injection, placebo of toxin + corticoid|"Intramuscular injection of placebo botulinum toxin (2 ml) under ultrasound control
~Subcutaneous injection (lateral epicondylitis side) of corticoid (2 ml of Hydrocortancyl® 2,5 %)"
15935048|NCT03380559|Drug|Injection, botulinum toxin + placebo corticoid|"Intramuscular injection of botulinum toxin (Xeomin® 50 U) under ultrasound control
~Subcutaneous injection (lateral epicondylitis side) of placebo of corticoid (2 ml of physiological saline solution NaCL 0.9 %)"
15935049|NCT03380546|Drug|Acarbose|Women will receive acarbose at an initial dose of 50 mg once daily in the beginning of the meal for which the postprandial glucose value is the highest, with progressive increase every 2 days or more: adding a pill before another meal, and then increasing dose of acarbose to 100 mg if post-prandial glucose goals are not obtained, with a maximal dose of 3 x 100 mg / day.
15935050|NCT03380546|Drug|Prandial insulin|Women will receive prandial fast-acting insulin according to usual practice (routine care according to French recommendations), i.e. one injection before each meal usually.
15935051|NCT03380533|Drug|Buprenorphine|Buprenorphine 10mg transdermal patch used during the first five postoperative days after arthroscopic rotator cuff repair
15935052|NCT03380533|Drug|Placebo Patch|Adhesive patch with the same macroscopic characteristics to the buprenorphine patch, without drugs.
15935053|NCT03380533|Drug|Multimodal Oral Scheme|Diclofenac 75mg c 12h Tramadol 50mg c 12h. Rescues with tramadol 50 mg (maximum rescue dose 150mg, minimum frequency between rescues 4hs)
15935054|NCT03380533|Drug|Tramadol|Tramadol 50mg tablet that the patient consumes every 8 hours during the first five days
15935055|NCT03380533|Drug|Placebo Tablet|Placebo tablet that the patient consumes every 8 hours during the first five days
15935056|NCT03380520|Drug|Ferric Carboxymaltose|Ferric carboxymaltose will be administered according to product specification dosing
15935057|NCT03380520|Drug|Placebo|IV nacl 0.9%
15935058|NCT03380507|Drug|Triple therapy group|Refer to arms description
15935059|NCT03380494|Other|Overhead perturbation training|A specifically chosen weight is attached to a 1m resistance band held above the head, hanging against gravity. The participant is encouraged to sustain a static position, where the weight and band provide variable magnitude perturbations to arm position. The body position of the participant is modified to facilitate greater and lesser perturbations. Bodily movements are prescribed to encourage joint perturbation. The participant undertakes 3 sets of 25 repetitions (60s rest) and continues with variable stimulus until fatigued.
15935060|NCT03380494|Other|Non-perturbed training|A weight is grasped by the participant and elevated above head to the same position as the OPT intervention. The participant is encouraged to sustain a static position. The body position of the participant is modified to facilitate greater and lesser perturbations. Bodily movements are prescribed to encourage joint perturbation. The participant undertakes 3 sets of 25 repetitions (60s rest) and continues with variable stimulus until fatigued.
15935061|NCT03380481|Other|observational only-no intervention|Observational only and no predesigned interventions in this study.
15935062|NCT03380468|Drug|cisplatin plus pemetrexed|cisplatin 75mg/m2 iv; pemetrexed 500mg/m2 iv
15935063|NCT03380455|Drug|Lucerastat|Single oral dose of 500 mg lucerastat under fasted conditions
15935064|NCT03380455|Drug|Cimetidine|Twice daily oral dose of 800 mg cimetidine under fasted conditions
15935065|NCT03380442|Drug|Psilocybin|Psilocybin ingested orally
15935066|NCT03380442|Drug|Ketamine (Ketalar)|Ketamine administered intranasally
15935067|NCT03380429|Drug|RELVAR/BREO|RELVAR/BREO will be available at doses of 100/25 micrograms (µg) and 200/25 µg to be administered via ELLIPTA DPI. Subjects will be administered one inhalation of RELVAR/BREO once daily.
15935068|NCT03380429|Drug|Salbutamol|Salbutamol will be available at a dose of 100 µg to be administered via MDI. Subjects will be administered salbutamol as and when required.
15935069|NCT03380429|Device|Smart phone app|Subjects will be required to download an app associated with sensor on their smartphone. The sensors attached to the inhalers will be connected to the smartphone via Bluetooth.
15935070|NCT03380429|Device|HCP Dashboard|The information from sensors will be reviewed by the HCP via an online dashboard.
15935071|NCT03380429|Device|Sensors|Clip-on sensors will be fitted to electronically record the actuation data.
15935072|NCT03380416|Other|Portfolio Diet|Medium-term (8 weeks ) nutritional intervention
15935076|NCT03380390|Drug|Oxymetazoline HCL 1.0% Cream|Oxymetazoline HCl cream 1.0% once daily application
15935077|NCT03380390|Device|Energy-Based Therapy|Energy-based therapies (Potassium Titanyl Phosphate [KTP], Pulsed Dye Laser [PDL], or Intense Pulsed Light [IPL])
15935078|NCT03380377|Drug|Clazakizumab|Clazakizumab 25 mg subcutaneous monthly x 6 doses (or max of 12 doses) will be given to patients who are enrolled in this clinical trial.
15935079|NCT03380364|Device|hystroscope|"Procedure: Hysteroscopy Office hysteroscopy will be performed during the proliferative phaseof the menstrual cycle.
~All OH (office hysteroscopy) procedures will be performed with a vaginoscopic approach without utilizing a speculum and applying traction to the cervix with a tenaculum.
~Antibiotic prophylaxis: None OH will be cancelled until after treatment of vaginal infection.
~Other Name: ROH: Routine Office Hysteroscopy Device: Hysteroscope The device used is a rigid hysteroscope (continuous flow, 30 degree forward oblique view) assembled in a 5-mm diameter diagnostic rigid sheath with an atraumatic tip (Karl Storz Endoscopy).
~Illumination: High intensity cold light source and fiberoptic cable Distention medium: solution of 0.9% normal saline with pressure at 100-120 mmHg"
15935080|NCT03380351|Behavioral|SCDIC interventions|The research team will characterize the intervention components and their implementation strategies.
15935081|NCT03380351|Behavioral|SCDIC control groups|The research team will characterize the control settings, including patients, providers and organization.
15935082|NCT03380338|Behavioral|Combined aerobic and strength exercise|
15935083|NCT03380325|Drug|Iloprost infusion|Iloprost is a stable prostacyclin analogue
15935084|NCT03380312|Procedure|rTARUP technique|robot-assisted rTARUP technique
15935085|NCT03380286|Device|Firehawk|Firehawk stent
15935086|NCT03380273|Behavioral|Implementation of the AO Trauma SSI Prevention Bundle|"AOT SSI Prevention Bundle
~Preventive measure
~Antibiotic prophylaxis
~Perioperative antibiotics
~Oxygen administration
~Patient temperature
~Surgeon protective wear
~Patient operative skin preparation
~Suction drains
~Blood glucose level
~Red cell transfusion
~Dressing changes"
15935087|NCT03380260|Behavioral|Paranoia Induction|Behavioral procedure involving social exclusion and negative feedback to induce paranoia
15935088|NCT03380234|Other|Worksheets|Worksheets will be distributed to students for them and their parents to complete together. During the first 3 months, the teachers will distribute 1 worksheet every two weeks to the intervention grades, and 1 worksheet in the 4th and 5th months as boosters. The worksheets will deliver information about tobacco smoke, SHS and THS, inviting students and their family members to complete other interesting tasks together.
15935089|NCT03380234|Other|Whatsapp messages|A mobile phone number of this study is also provided on the worksheets, through which participants can receive WhatsApp/WeChat/instant messages (1-2 times every week) designed to encourage behavioural change [15]. They can then forward selected messages to other members of their household, especially smokers.
15935090|NCT03380234|Other|Online quizzes|At the end of each worksheet, a QR code is inserted. By scanning this code, students or parents will be invited to answer 2-3 simple quizzes which allow us to assess students' knowledge obtained from the intervention materials and their avoidance of environmental tobacco smoke.
15935091|NCT03380234|Other|Leaflet|A leaflet on smoking and SHS published by the Department of Health will be mailed to the control grades.
15935092|NCT03380221|Other|Watermelon|Participants will consume 100 Kcal of watermelon fruit (2 cups) daily for 4 weeks.
15935093|NCT03380221|Other|Low fat cookies|Participants will consume 100 Kcal of low fat cookies daily for 4 weeks.
15935094|NCT03380195|Other|Watermelon juice|Subject drinks 355ml of watermelon juice 1 hour prior to submaximal exercise
15935095|NCT03380195|Other|Sport drink|Subject drinks 355ml of Gatorade 1 hour prior to submaximal exercise
15935096|NCT03380195|Other|Sugar water|Subject drinks 355ml of sugar water (22.5g) 1 hour prior to submaximal exercise
15935097|NCT03380195|Other|Water|Subject drinks 355ml of water 1 hour prior to submaximal exercise
15935098|NCT03380182|Other|Acupressure Band|These bands use pressure to stimulate the P6 acupuncture point.
15935099|NCT03380182|Other|Sham Band|These sham bands are used to make it seem like the band is using pressure to stimulate the P6 acupuncture point.
15935100|NCT03380169|Other|Prophylactic advance wound dressing|A combination of dressing including occlusive moist wound dressing to provide a barrier from the external environment and silver-containing dressing to reduce the inflammation of wounds and promotes healing
15935101|NCT03380169|Other|Prophylactic conventional wound dressing|Conventional gauze dressing
15935102|NCT03380156|Device|TVS|Active TVS will be performed by use of a Tragus stimulator device with electrodes attached to the tragus of the ear. Stimulator will be applied continuously for 1 hour
15935103|NCT03380156|Device|Sham TVS|Device will be applied but not to the Tragus of the ear but will be attached to the ear lobule.
15935104|NCT03380143|Behavioral|Wellness Landscape Intervention|Community and organization systems intervention targeting youth population physical activity
15935105|NCT03380143|Behavioral|Standard Practice|Community development intervention
15935106|NCT03380130|Drug|Nivolumab|An anti-programmed death 1 monoclonal antibody
15935107|NCT03380130|Device|SIR-Spheres|Resin microspheres labeled with the radioactive isotope yttrium 90 that serves as a source of beta radiation
15935108|NCT03380117|Behavioral|eBridge Online Counseling|In eBridge, students take an online screen and receive personalized feedback about their self-reported depression, alcohol/substance use, and level of functioning. Students are randomly assigned to either the eBridge or control condition. In the eBridge condition, personalized feedback is provided in a graphic format that is accompanied by motivational-interviewing-adherent statements. In this condition, students' communications with eBridge counselors will occur via online dialogues, in which students and counselors exchange messages using a secure website. In the control condition, personalized feedback will also be delivered online to students, highlighting their personal data and specify links between key screening variables and negative outcomes. However, in the control condition, this is provided in a straightforward graphic, informational format, which is consistent with standard practice in online screening programs for college students.
15935109|NCT03380104|Device|Intradural Spinal Cord Stimulation|The device will be placed percutaneously at the lumbar spine at L2-3 or L3-4 level into the intrathecal CSF space and advanced to the T8-10 disc space. After positioning of the intrathecal lead, the stimulation catheter will be run through a standardized experimental algorithm consisting on various frequencies.
15935110|NCT03380104|Behavioral|Administration of Questionnaires|Subjects will be administered questionnaires to evaluate pain, quality of life, and global function prior the study, at 1 hour after the completion of the study, and at 4 day follow-up appointment.
15935111|NCT03380091|Drug|Metformin|Oral medication daily
15935112|NCT03380091|Drug|Vitamin D|Oral medication daily
15935113|NCT03380078|Behavioral|Teams Leadership Institute (TLI)|TLI is training for leaders in how to improve implementation of evidence-based interventions in community settings. TLI includes 5 key components : 1. Assessment: The Implementation Leadership Scale (ILS) and Implementation Climate Scale (ICS) will be completed by first-level leaders participating in the intervention, his/her subordinates (i.e. providers) and executive leaders. 2. Initial Training: a 3-hour didactic and interactive session that includes training in implementation leadership Leaders will develop a plan for using specific implementation support strategies. 3. Coaching: Weekly, brief (15-30 min) coaching calls keep leaders on track with goals and plans. Coaching includes review of progress toward goals, updating plan based on emergent issues, and problem solving. 4. Follow up : At month 4, leaders attend a 2-hour booster session . 5. Graduation: TLI programs will have a group-based graduation for the leaders and provider trainees at EBI training completion.
15935114|NCT03380078|Behavioral|Motivational Enhancement (TIPS for Training)|The TIPS module applies MI principles and strategies to address attitudinal barriers and improve engagement in training. I AIM HI and CPRT trainers (in the TIPS Conditions ) will incorporate MI during training and ongoing consultation/coaching with providers to increase provider engagement and problem solving throughout training: 1. Providers will receive a call designed to provide information about training and the intervention. 2. During the workshop, trainers will assess concerns about participating and will use reflective problem solving to address barriers . Trainers will work with the provider to develop a plan through the use of Planning Worksheets . 3. During each consultation , planning worksheets will be updated collaboratively with the provider. 4. Providers will receive a weekly motivational text to encourage on-going participation.
15935115|NCT03380078|Behavioral|Classroom Pivotal Response Teaching (CPRT)|CPRT is a naturalistic behavioral intervention adapted from pivotal response training (PRT) for use during classroom activities to target social, communication, behavior, and learning skills. CPRT is a manualized program with user-friendly materials for training, intervention planning and fidelity monitoring provided in printed and web-based formats. CPRT has an established training plan and the training curriculum that follows the manual. Training and coaching including standard EBI training is conducted by MA or postdoctoral level researchers with extensive training and experience with CPRT.
15935116|NCT03380078|Behavioral|An Individualized Mental Health Intervention for ASD (AIM HI)|A package of well-established, evidence-based behavioral strategies designed to reduce challenging behaviors in children served in MH service settings. AIM HI is a manualized program with user-friendly materials for training, intervention planning and fidelity monitoring provided in printed and web-based formats. AIM HI is a package of evidence-based parent-mediated and child focused strategies, designed to reduce behavior problems in children with ASD ages 5 to 13 served in MH programs. AIM HI has an established training plan and the training curriculum follows the manual. Training and coaching is conducted by MA or postdoctoral level researchers with extensive training and experience with AIM HI.
15935117|NCT03380065|Device|Late deflation of TR band|"First 3ml of air is removed after TWO hour of sheath removal. Then, 3ml of air is removed every 15minutes.
~Observe for any bleeding or hematoma. During every deflation, if any bleeding or hematoma is noticed then 3ml of air is pushed back into the device until bleeding stops. Then a gap of 15minutes is observed for the next deflation."
15935118|NCT03380065|Device|Early deflation of TR band|"First 2ml of air is removed from the band ONE hour after sheath removal. Then, 2ml of air is removed every 30minutes.
~Observe for any bleeding or hematoma. During every deflation, if any bleeding or hematoma is noticed then 2ml of air should be pushed back into the device until bleeding stops. Then wait for another 30minutes for the next deflation."
15935119|NCT03380039|Genetic|CAR-BCMA T cells|"Single dose of CAR-BCMA T cells will be infused, and classic 3+3 dose escalation will be applied."
15935120|NCT03380039|Drug|Fludarabine|Fludarabine is used for lymphodepletion.
15935121|NCT03380039|Drug|Cyclophosphamide|Cyclophosphamide is used for lymphodepletion.
15935122|NCT03380026|Drug|Triamcinolone|Apply up to three times daily on select lesions.
15935123|NCT03380026|Drug|Valchlor 0.016 % Topical Gel|Apply valchlor nightly on select lesions.
15935124|NCT03380013|Procedure|Osteopathic Manipulative Treatment (OMT)|Each neonate will have a structural exam completed assessing each body region (head, cervical, thoracic, lumbar, sacral, pelvic, rib cage, and abdominal regions) for underlying somatic dysfunctions prior to each treatment. The specific OMT techniques used will be left to the discretion of the treating physician and will not be based on a predetermined protocol. Treatment techniques will consist of myofascial release, balanced ligamentous tension, balanced membranous tension, and osteopathy in the cranial field. Total treatment time will be 15 minutes. The features of the osteopathic structural exam which will be recorded on paper by the treating physician at the time of the evaluation. The paper will be marked only with the research identifier.
15935125|NCT03380000|Drug|Beetroot juice|This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK).
15935126|NCT03380000|Drug|Beetroot juice placebo|This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK).
15935127|NCT03379987|Drug|PVB morphine|The PVB was performed under ultrasonographic guidance in the sitting position. Surgical disinfection of thoracoabdominal paravertebral area was done. A linear high-frequency transducer (10-12 MHz, Sonosite, Bothell, WA, USA) was used. The scanning process (Longitudinal out-of-plane technique) was started at 5-10 cm lateral to the spinous process of thoracic vertebrae to identify the rounded ribs and parietal pleura underneath. The transducer is then moved progressively more medially until the transverse processes are identified as more squared structure deeper to the ribs. A 100 mm needle was inserted out-of-plane to contact the transverse process of thoracic vertebra and then, walked off above the transverse process 1-1.5 cm deeper searching for loss of resistance injecting 10 ml of 0.25% bupivacaine + 3 mg morphine for group PVB morphine in incremental doses of 3 ml.
15935128|NCT03379987|Drug|PVB bupivacaine|the same steps mentioned in group PVB morphine but the solution used for paravertebral block contain bupivacaine only 10 ml of 0.25% bupivacaine injected in in incremental doses of 3 ml.
15971620|NCT03100097|Device|Aspen Horizon 627 LSO|
15935129|NCT03379974|Drug|DDAVP Inhalant Product|For the DDAVP intervention the participant will take either 1 or 2 nasal sprays of IN DDAVP. After receiving IN DDAVP, the participant will rest for 30 minutes.
15935130|NCT03379974|Behavioral|Exercise Intervention|For the exercise intervention the participant will exercise on a stationary cycle-ergometer using the previously-validated, progressively-incremental Godfrey protocol. Per the Godfrey protocol, the participant starts cycling on the calibrated cycle-ergometer with an initial exercise load that is dependent on their height. The workload is increased every minute in standard increments also based on the participant's height. All participants will exercise till they complete 3-minutes of cycling at 85% of their maximum predicted heart rate or till exhaustion (whichever comes first). Upon completion of planned exercise, work load will be decreased to zero watts and participants will be instructed to continue cycling at this cool-down rate for additional 3-minutes, before getting of the ergometer.
15935131|NCT03379948|Diagnostic Test|blood culture|blood culture to diagnose blood stream infection
15935132|NCT03379935|Procedure|Type of radial head arthroplasty|Patiens are either treated with a unipolar or a bipolar radial head arthroplasty. At Sundsvall hospital all patients were treated with a unipolar and at Umeå university hospital all patients were treated with a bipolar arthroplasty.
15935133|NCT03379922|Behavioral|Stress balls|Squeezing stress balls while receiving ESWL treatment
15935134|NCT03379922|Behavioral|Headphones|Listening to music while receiving ESWL treatment
15935135|NCT03379909|Drug|Metformin|Metformin orally at doses up to 1500 mg twice daily for 3 months.
15935136|NCT03379896|Other|Collect peripheral blood sample|Collect 20 ml heparinized blood from patients and controls strictly abiding by the principle of aseptic manipulation after informed consent.
15935137|NCT03379883|Procedure|Pulsed radiofrequency (P-RF)|"Intra articular RF
~Insertion of the RF cannula within the joint. The recommended parameters are a pulse width of 20 msec and a rate of 2 Hz at 42°C for 10min.
~Genicular nerve RF ablation.
~The RF probe will be placed. A 50 Hz-frequency sensorial stimulation will be applied with a threshold of < 0.6 V"
15935138|NCT03379883|Procedure|Platelet rich plasma (PRP)|Under ultrasound guidance while the patients in a sitting position. In total, 3 to 8 mL of PRP will be injected via the inta-articular route
15935139|NCT03379870|Device|Electric Acoustic Speech Processor: EAS fitting|Electric Acoustic Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or better,
15935140|NCT03379870|Device|Electric Acoustic Speech Processor: Electric only fitting|Electric Stimulation for children with post-operative residual low frequency hearing averages of 75 dB HL or poorer and pre-operative low frequency hearing averages of 75 dB HL or better.
15935141|NCT03379857|Other|Drug urinal test|Non Applicable
15935142|NCT03379844|Device|Holmium-166 radioembolization|An intra-arterial radioembolization procedure will be performed. The hepatic artery catheter is inserted via the femoral or radial artery under x-ray guidance by a trained interventional radiologist. The radiologist must repeatedly check the position of the catheter during the procedure to ensure it remains correctly sited and that reflux of the QuiremSpheres® into other organs does not occur. This is performed by injecting contrast medium. At the conclusion of the procedure, the catheter is removed.
15935143|NCT03379818|Behavioral|Shape training intervention|This intervention is based on on a study conducted by Smith and colleagues (2002), where they found that teaching typically developing infants to attend to shape by the end of the second year of life significantly enhances their word learning. Participants will be taught that the significant property they should focus in when learning and extending novel labels is shape. This will be done through play-like sessions.
15935144|NCT03379818|Behavioral|Specific word training|"In this intervention, participants will be taught the names of 28 real objects. The target words have been selected from the Wordbank database, which is an open database that lists the proportion of children that know a specific word at a specific age. Twenty-eight words that are understood by 80% of the total child population at 25 months were randomly selected as target words. Techniques such as focused stimulation and modelling target words, which have proved to be useful for word learning, will be used."
15935145|NCT03379805|Diagnostic Test|Near Infrared Fluorescence Imaging|The functional state of lymphatics is investigated using near infrared fluorescence imaging, NIRF.
15935146|NCT03379805|Diagnostic Test|Non-contrast MRI|The anatomy is described using non-contrast MRI.
15935147|NCT03379805|Diagnostic Test|Strain Gauge Plethysmography|The capillary filtration rate is measured using plethysmography
15935148|NCT03379792|Other|DEXA|Measurement of body composition by Dual Energy X-ray Absorptiometry (DEXA)
15935149|NCT03379792|Other|MRI|Whole body magnetic resonance imaging (MRI)
15935150|NCT03379792|Other|CGM|A continuous glucose monitor (CGM) will be placed on the participant and will be used as a safety measure to monitor glucose levels.
15935151|NCT03379792|Other|Whole room calorimeters|Whole room indirect calorimetry allows for the simultaneous measure of total energy expenditure and substrate oxidation in a free living environment with multiple activities.
15935152|NCT03379792|Other|Dietary counseling|The low carbohydrate diet counseling will be to assist young adult, overweight study participants with Type 1 diabetes in adhering to a lower calorie diet (500 calorie deficit)
15935153|NCT03379779|Diagnostic Test|16s RNA sequence of sputum, bronchoalveolar lavage fluid (options), stool|We will check the microbiome in lower respiratory samples (sputum and bronchoalveolar lavage fluid) and stool by using 16S RNA sequencing
15935154|NCT03379766|Device|Successor of Phonak Audéo B-Direct|The successor of Phonak Audéo B-Direct will be fitted to the participants indivudal hearing loss.
15935155|NCT03379766|Device|Phonak Audéo B-Direct|The Phonak Audéo B-Direct will be fitted to the participants individual hearing loss.
15935156|NCT03379753|Other|music and positive images|The diad of misic and positive image will be administered to the standard care by adding a Bluetooth capable speaker with selections of music and a soothing nature landscape into the hospital room.
15935157|NCT03379740|Other|E-cigarette|Subject's own e-cigarette
15935158|NCT03379740|Other|P4M3-1.7%|P4M3 e-liquid concentration of 1.7% nicotine without lactic acid
15935159|NCT03379740|Other|P4M3-1.7%LA|P4M3 e-liquid concentration of 1.7% nicotine with lactic acid
15935160|NCT03379740|Other|P4M3-3%LA|P4M3 e-liquid concentration of 3% nicotine with lactic acid
15935161|NCT03379740|Other|P4M3-4%LA|P4M3 e-liquid concentration of 4% nicotine with lactic acid
15935163|NCT03379714|Device|WEB aneurysm embolization system|The WEB aneurysm embolization system is a class III device and consists of an implantable embolization device attached to a delivery device. The WEB is a mesh composed of single layers of braided nitinol tubes with platinum cores. The braids are held together by proximal and distal platinum/ iridium radiopaque markers.
15935164|NCT03379675|Drug|JNJ-53718678 500 mg|Participants will receive 500 mg dose of JNJ-53718678 oral solution once daily for 7 days.
15935165|NCT03379675|Drug|JNJ-53718678 80 mg|Participants will receive 80 mg dose of JNJ-53718678 oral solution along with the matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.
15935166|NCT03379675|Drug|Placebo|In treatment B, participants will receive matching placebo along with JNJ-53718678 to maintain the same total volume as for the 500 mg dose once daily for 7 days. In treatment C, participants will receive matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.
15935167|NCT03379662|Device|Erchonia HLS Laser|The Erchonia HLS Laser emits a 640 nm (nanometer) wavelength with a tolerance of ±10 nm from each of two 7.5 mw (milliwatt) laser diodes.
15935168|NCT03379662|Device|Placebo Laser|The Placebo Laser emit the same visible light output as the active HLS Laser but without therapeutic effect.
15935169|NCT03379649|Combination Product|Platelet rich plasma|Patients will have 60ml of blood drawn. Platelet rich plasma will be obtained by placing the blood in the Arteriocyte Magellan device. 0.5ml of Platelet rich plasma will be placed into the uterus at least 48 hours prior to embryo transfer.
15935170|NCT03379649|Combination Product|Placebo|Patients will have 60ml of blood drawn. 0.5ml of embryo culture media (the placebo) will be placed into the uterus at least 48 hours prior to embryo transfer.
15935171|NCT03379636|Device|kinesiotape|Application of an elastic beige 5-cm width Leukotape®K (BSN medical, Germany). The first strip, a Y-strip, was applied with 10% to 15% of tension over the deltoid muscle, from origin to insertion with the first tail along the anterior deltoid while the arm was externally rotated and horizontally abducted. The second tail was applied along the posterior deltoid with the arm horizontally adducted and internally rotated. A second strip, an I-strip, was applied for mechanical correction, transversally in the sagittal plane over the acromioclavicular joint with a downward pressure applied to the KT, the arm being at trunk side
15935172|NCT03379636|Device|sham tape|a rigid Leukotape®Classic (BSN medical, Germany) was used. A 5-cm strip was applied transversally under the deltoid tuberosity with no tension and with no direct influence on shoulder area.
15935173|NCT03379623|Other|ESCAPE-pain Programme|The Enabling Self-management and Coping with Arthritic (knee) Pain using Exercise (ESCAPE-pain) is a programme of rehabilitation that integrates educational self-management and coping strategies for people with joint pain with an individualised exercise regimen for each participant. The implementation of the programme will be conducted by the researcher as a certified facilitator by using Clinician's training manual for the ESCAPE-pain programme.
15935174|NCT03379610|Diagnostic Test|Nasopharngeal brush|"Baseline nasopharngeal brush before treatment
~Post-treatment reassessment of residual NPC"
15935175|NCT03379597|Drug|Bifico (Live combined bifidobacterium,Lactobacillus and Enterococcus capsules, Oral)|Bifico 840mg Bid
15935176|NCT03379597|Dietary Supplement|Dietary fiber|dietary fiber compound powder 30g bid
15935177|NCT03379584|Drug|SGN-CD48A|Intravenous (IV) infusion on days 1, 8, and 15 of a 28-day cycle
15935178|NCT03379558|Drug|ALIROCUMAB SAR236553 (REGN727)|Pharmaceutical form:as per routine practice Route of administration: subcutaneous
15935179|NCT03379545|Diagnostic Test|3-dimensional (3D) magnetic resonance (MR) imaging|MRI is performed using 3T scanners with a dedicated 16-channel shoulder array coils. The MRI sequences include 3-mm slice thickness and 0.5-mm gap width with a field of view of 14 or 15 cm. There were 6 diagnostic sequences with axial, coronal, and sagittal proton density weighting as well as coronal T2 with frequency selective fat suppression and sagittal T1 images.
15935180|NCT03379545|Diagnostic Test|3D computed tomography (CT) imaging|The CT protocol consists of 3-mm axial images of the glenoid reconstructed into 1-mm sagittal and coronal 2D reconstructions using the following parameters: 120 kV, 280 mA, and pitch of 0.9. The CT data were also used to produce a 3D reconstruction of each glenoid.
15935181|NCT03379532|Device|BCI-NMES|From the recorded brain activity (EEG) subject specific patterns will be extracted with machine learning techniques from recordings where the subject executes movements tasks. Whenever a subject-specific pattern can be identified and detected, this is used for triggering neuromuscular electrical stimulation.
15935182|NCT03379532|Device|Sham-NMES|Neuromuscular electrical stimulation is triggered independently of the patient's movement intentions.
15935183|NCT03379519|Behavioral|Multi-domain Attention Training (MAT)|The training content emphasis three concept of attention include: intensity of attention, executive attention, and spatial orienting attention.
15935184|NCT03379519|Behavioral|Passive information activities (PIA)|The active control group (Passive information activities) training content included reading online e-books and playing online games.
15935185|NCT03379506|Drug|EBR/GZR FDC Tablet|Participants who are 12 to <18 years of age will receive oral FDC tablets with EBR 50 mg/GZR 100 mg once daily by mouth.
15935186|NCT03379506|Drug|Placebo|Placebo tablet matched to EBR/GZR FDC tablet.
15935187|NCT03379506|Drug|Grazoprevir Oral Granules|Participants 3 to <12 years of age take grazoprevir granules 0.5 mg by mouth in a soft food vehicle at a dose not to exceed 50 mg.
15935188|NCT03379506|Drug|Elbasvir Oral Granules|Participants 3 to <12 years of age take elbasvir oral granules 1 mg by mouth in a soft food vehicle at a dose not to exceed 100 mg.
15935189|NCT03379493|Biological|ET190L1 ARTEMIS™ T cells|Autologous T cells transduced with lentivirus encoding an anti-CD19 (ET190L1) ARTEMIS™ expression construct, administered by intravenous (IV) infusion
15935190|NCT03379480|Behavioral|Yoga arm|Yoga module developed for patients with Schizophrenia
15935191|NCT03379467|Other|SMS Reminder|A text message sent as a reminder for immunization on the registered phone number
15935192|NCT03379467|Other|Interactive Reminder|A text message sent as a reminder for immunization on the registered phone number which requires the receiver to respond back
15935193|NCT03379441|Drug|Pembrolizumab Injectable Product|Pembrolizumab Injectable Product 200 mg Q3W Intravenous
15935194|NCT03379428|Drug|Trastuzumab|8 mg/kg loading dose (first dose), followed by 6 mg/kg every 3 weeks, administered intravenously (IV)
15935198|NCT03379415|Device|Footwear|Different types of footwear will be tested to see if these can be used to help slow the progression of osteoarthritis in meniscectomy patients or even stop it from occurring.
15935199|NCT03379415|Procedure|Gait analysis|Gait analysis will be done during several different tasks wear the footwear
15935200|NCT03379402|Other|Specimens collection|"On admission: Blood samples 30.01 mL and other specimens (if available) for culture and other diagnostics tests including sputum, throat swab, urine (midstream urine), and pus which is part of routine practice for patients with sepsis at study site.
~Day 3: Blood (15 mL) for culture (10 mL) and PCR (5 mL). There will be no blood collection, if patient is discharged before day 3."
15935201|NCT03379389|Drug|Methenamine + Methylthioninium|Methenamine + Methylthioninium
15935202|NCT03379389|Drug|Methenamine + Methylthioninium + Acriflavine + Atropa belladona|Methenamine + Methylthioninium + Acriflavine + Atropa belladona
15935203|NCT03379389|Drug|Antibiotics|Antibiotics based on individual subjects urine culture / antibiogram
15935204|NCT03379376|Other|Questionnaire Administration|Receive questionnaire
15935205|NCT03379376|Procedure|Supportive Care|Undergo eHealth mindful moving and breathing
15935206|NCT03379350|Procedure|clamping group|Clamping group are managed with clamping protocol after 3pm on the postoperative day as follow: the chest tube will be clamped, and the nurses will check the patient every 6 h. If the patient has no problems with compliance, the clamp will be removed for half an hour in the morning to record the drainage volume every 24 h.
15935207|NCT03379337|Diagnostic Test|Dental imaging|The target teeth positions for imaging included 4 incisors and all 4 canines. Only the vestibular and interproximal regions were of interest. Images were taken of these target teeth positions regardless of whether or not they exhibited plaque, consisted of full or partial restorations, contained major cracks/fractures, chips, or were missing. Other captured images included any abnormality of the tooth or gum exhibiting red fluorescence physically accessible by the devices.
15935208|NCT03379324|Biological|Superiority of augmented repairs|4cc of FlōGraft® injected into repair subject tissue divided evenly between repair site and muscle body
15935209|NCT03379324|Biological|Fat degeneration of supraspinatus muscle|4cc of FlōGraft® injected into repair subject tissue divided evenly between repair site and muscle body
15935210|NCT03379311|Drug|AK002|AK002 is a humanized non-fucosylated immunoglobulin G1 (IgG1) monoclonal antibody directed against Siglec-8, a member of the CD33-related family of sialic acid-binding, immunoglobulin-like lectins (Siglecs).
15935211|NCT03379259|Drug|BGB-A333|Anti-PD-L1 antibody
15935212|NCT03379259|Drug|BGB-A333 and BGB-A317|Anti-PD-L1 and anti-PD-1 antibodies
15935213|NCT03379233|Combination Product|Concept2 inhaler|Fixed combination of Indacaterol maleate (QAB149) and glycopyrronium bromide (NVA237), 110/50 μg, capsule added to Concept2 inhaler
15935214|NCT03379233|Combination Product|Concept2 inhaler with patient application|Fixed combination of Indacaterol maleate (QAB149) and glycopyrronium bromide (NVA237), 110/50 μg, capsule added to Concept2 inhaler with application used for monitoring
15935215|NCT03379207|Other|Blood samples|Blood samples for research purpose, taken whenever possible during blood sampling for routine purpose
15935216|NCT03379207|Other|Tracheal Aspirates|Only for mechanically ventilated participants.
15935217|NCT03379207|Other|Surplus of Broncho-alveolar lavage fluid|Only if performed for diagnosis purpose by the treating investigator : indication left at his discretion
15935218|NCT03379194|Behavioral|Antibiotic stewardship program|Routine feedback on antibiotic prescriptions in addition to evidence based guidelines for the management of acute respiratory and urinary tract infection and patient leaflets for using antibiotics wisely
15935219|NCT03379181|Drug|Propranolol|Patients receive a single dose of 80 mg propranolol p.o.
15935220|NCT03379168|Device|Microfragmented Adipose Tissue (Lipogems)|Lipogems is a technique to harvest, process, and inject minimally manipulated adipose tissue. This procedure is enzyme free and requires no clonal expansion or manipulation. Lipoaspirate is harvested most commonly from the abdomen and washed in saline solution, then processed through a closed-system device that micro-fragments the adipose tissue. This mechanical process retains the vascular architecture, mature pericytes, and MSCs for autologous injection. Lipogems is currently FDA-approved for orthopedic and arthroscopic procedures; thus, this would be an on-label use for knee injections.
15935221|NCT03379168|Drug|Corticosteroid injection|Cortisone is a standard of care injection to reduce joint inflammation.
15935222|NCT03379168|Drug|Saline|Sterile saline injection will act as a placebo group.
15935223|NCT03379155|Other|Internet-based self-help program|The intervention provided is based on the principles of cognitive behavioral therapy (CBT) (Bachem & Maercker, 2013). The manual integrates a variety of approaches validated as treatments for PTSD, anxiety disorders, or depression; the selection focuses on exercises which are intended to target the main symptoms of AjD, namely preoccupations (e.g. constant rumination, excessive worry about the stressor) and failure to adapt (e.g. sleep disturbance, difficulties concentrating, loss of interest in previously enjoyable activities).
15935224|NCT03379142|Behavioral|Faith-Based messages|We will send out faith based text messages on a weekly basis for the one week prior to the start of Ramadan, then twice a day during the Ramadan period that will encourage smoking cessation and continue to encourage change of behavior. The faith-based messages will be incorporated with messages drawn from the Smokefree.gov Mobile Interventions QuitNowTXT Message Library. These messages will be geared towards reminding the smokers that as Ramadan is coming closer they need to consider the effects that smoking may have on their health and should consider taking steps towards quitting.
15935225|NCT03379116|Other|enteral nutrition and parenteral nutrition|In the treatment of the burned patients injured,data on nutritional support and patient's outcomes were collected and analyzed.
15935226|NCT03379103|Drug|Sevoflurane|Patients will receive 1 MAC sevoflurane for 15 minutes before the installation of member ischemia by tourniquete
15935227|NCT03379103|Drug|Propofol|Patients will receive propofol for 15 minutes before the installation of member ischemia by tourniquete
15935266|NCT03378739|Procedure|Cardiogenic Shock team activation|Any patient with cardiogenic shock, whether inpatient or transferred from another facility, treated at the Inova Heart and Vascular Institute by the designated Cardiogenic Shock Team.
15935267|NCT03378726|Dietary Supplement|Micronutrients|Micronutrient powder is the current supplement provided by the Colombian Ministry of Health and Social Protection to children between 1 and 5 years of age.
15935228|NCT03379077|Behavioral|LTP Plus|LTP Plus is comprised of two components; Learning through play (LTP) and Cognitive Behavior Therapy (CBT). The LTP Plus is a low-literacy, sustainable program intended to provide parents with information on the healthy growth and development of their young children. The LTP research-based activities enhance children's development while simultaneously promoting attachment security through building parents' ability to read and be sensitive to their children's cues and through active involvement in their children's development. Plus the Thinking Healthy Program (THP) which adopts 'here and now' problem-solving approach. THP uses cognitive behavior therapy (CBT) techniques of active listening, changing negative thinking, and collaboration with the family.
15935229|NCT03379064|Behavioral|Culturally adapted Cognitive Behavior Therapy for IBS|Culturally adapted Cognitive Behavior Therapy for IBS
15935230|NCT03379051|Drug|Venetoclax|BCL-2 Inhibitor
15935231|NCT03379051|Drug|Umbralisib|PI3K-Delta Inhibitor
15935232|NCT03379051|Biological|Ublituximab|Glycoengineered Anti-CD20 mAb
15935233|NCT03379051|Drug|Lenalidomide|Thalidomide Analog, immunomodulatory agent with antiangiogenic and antineoplastic properties
15935234|NCT03379038|Other|Progressive Physical Therapy|Stretching of the tight muscle, positioning, abdominal co activation; rolling etc to decrease muscle tone and functional independence.
15935235|NCT03379038|Other|Maintenance Physical Therapy|Same Physical therapy protocol but aim was to maintain current level of spasticity and functioning
15935236|NCT03379025|Other|Electronic cigarette|electronic cigarette and cartridge refills (also known as pods)
15935237|NCT03379012|Drug|Testosterone undecanoate and sunitinib or pazopanib|Testosterone undecanoate (Nebido®) 1,000 mg (4 ml) intramuscular deeply, once before targeted therapy (sunitinib 50 mg 4/2 or pazopanib 800 mg daily)
15935238|NCT03378999|Dietary Supplement|Rhodospirillum rubrum|Capsules containing oven-dried Rhodospirillum rubrum
15935239|NCT03378999|Dietary Supplement|Control|Capsules containing microcrystalline cellulose
15935240|NCT03378986|Procedure|Unilateral total hip arthroplasty|Replacement of one hip joint through a mininvasive surgical procedure
15935241|NCT03378986|Procedure|Simultaneous bilateral total hip arthroplasty|Replacement of both hip joints through one-stage mininvasive surgical procedure
15935242|NCT03378973|Drug|Dexmedetomidine|Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery.
15935243|NCT03378960|Drug|Omeprazole 20mg|
15935244|NCT03378947|Other|clinical and pathological data EBV-related GZL and DLBCL|"Invesrigators will retrospectively collect clinical and pathological data of all EBV-related GZL and DLBCL in immunocompetent patients diagnosed in the pathology department Centre Hospitalier Lyon Sud.
~Investigators will analyze their clinical feature and prognosis."
15935245|NCT03378934|Drug|Berberine|Berberine 200 mg twice daily for 4±1 weeks (Stage 1); then, 300 mg twice daily for 4±1 weeks (Stage 2); then, 400 mg twice daily for 4 weeks (Stage 3).
15935246|NCT03378934|Drug|Standard treatment|Standard treatment for 12±1 weeks.
15935247|NCT03378934|Drug|Aspirin|Aspirin 100 mg once daily for 12±1 weeks.
15935248|NCT03378934|Drug|Clopidogrel|Clopidogrel 75 mg once daily for 12±1 weeks.
15935249|NCT03378921|Biological|Fecal microbiota transplantation|Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52.
15935250|NCT03378921|Biological|Placebo|Follow up of the patients include a telephone call after 12 and 26 weeks after the FMT, and a clinical control visit 52 weeks after the transplantation. The clinical part of the Pouchitis Disease Activity Index score is assessed during each call and clinical visit. Fecal stool samples for phylogenetic analysis are collected before FMT and on weeks 4, 12, 26, and 52.
15935251|NCT03378908|Behavioral|Intervention Treatment|Both groups (conventional and treatment) will have the same nutritional composition, with 40% carbohydrates, 20% protein and 40% total fat (preferently monounsaturated fatty acids).
15935252|NCT03378895|Behavioral|online questionnaire|Risk assessment identified by online questionnaire
15935253|NCT03378882|Biological|Parasitic serologies|"Suspected angiostrongylosis - Angiostrongylus cantonensis:
~An aliquot of CSF and an aliquot of serum will be sent to the laboratory of tropical medicine in Switzerland for research of specific antibodies.
~A CSF aliquot will be sent to the CDC for PCR.
~Suspected angiostrongylosis- Angiostrongylus costaricensis:
~- An aliquot of serum will be sent to the laboratory of tropical medicine in Switzerland for research of specific antibodies."
15935254|NCT03378882|Procedure|Biopsy|"Suspected angiostrongylosis - Angiostrongylus costaricensis:
~- A piece of biopsy or intestinal resection will be sent to the pathology laboratory for parasitic elements suggestive of Angiostrongylus costaricensis infection"
15935255|NCT03378869|Procedure|esophagectomy|all the included participants had received esophagectomy, either Ivor Lewis or tri-incision, or more complex procedures.
15935256|NCT03378843|Other|Spermidine content of natural diet|The exposure consists in the long-term average dietary intake of the polyamine spermidine
15935257|NCT03378817|Procedure|HOPE|HOPE for 1 hour via the renal artery in a recirculating and pressure controlled system, Belzer (UW) machine perfusion solution, perfusate temperature 0-4 °C, perfusate oxygenation pO2 of 60-80 kPa Other Name: Hypothermic machine perfusion (HMP)
15935258|NCT03378817|Other|Conventional cold storage|No intervention
15935259|NCT03378804|Procedure|Programmed intermittent epidural bolus application (PIEB)|Instead of a continuous background infusion of 6ml/h, one bolus injection is performed at the same amount per hour.
15935260|NCT03378804|Procedure|Continous epidural analgesia|
15935261|NCT03378791|Drug|Iron bisglycinate Oral Tablet|
15935262|NCT03378791|Drug|Ferrous Fumarate Oral Tablet|
15935263|NCT03378778|Procedure|Root canal treatment|Root Canal Treatment followed by Ceramic Onlay restoration
15935264|NCT03378765|Behavioral|Diet and physical activity monitoring|Lifestyle monitoring
15935265|NCT03378752|Procedure|HFJV|On High frequency jet ventilation, Every 15 minutes, after induction of general anaesthesia, a computed tomography of the lower part of the lungs are taken (10 cm volume, with the top of the right diaphragm as the lower border)
15935268|NCT03378726|Behavioral|SPOON Group Counseling|SPOON group counseling is an innovative behavior change strategy in which participants will learn information related to child health and nutrition in a group format.
15935269|NCT03378726|Behavioral|Interpersonal Counseling|SPOON interpersonal counseling is an innovative behavior change strategy in which participants will learn information via one-on-one sessions with the instructor.
15935270|NCT03378726|Dietary Supplement|SQ-LNS|SQ-LNS is a peanut-based dietary supplement that has been shown to increase children's height and weight in several studies in Africa.
15935271|NCT03378726|Behavioral|Standard Counseling|Standard counseling refers to the counseling currently provided by health personnel to women and children in the selected intervention area of Colombia
15935272|NCT03378713|Drug|GROUP 1: Long testosterone|Application of testosterone in transdermal gel during the 2 cycles prior to initiation of controlled ovarian stimulation and until the onset of second menstruation (approximately 56 days). The COS begins the day after the last testosterone application
15935273|NCT03378713|Drug|GROUP 2: Short testosterone|Application of testosterone in transdermal gel begins on day 21 of menstrual cycle, from the luteal phase of the cycle prior to initiation of controlled ovarian stimulation and until menstruation (approximately 10 days). The COS begins the day after the last testosterone application.
15935274|NCT03378713|Drug|GROUP 3: Control|The COS starts directly on the second day of the cycle without prior medication.
15935275|NCT03378700|Behavioral|Brief Hope Intervention|"The present Brief Hope Intervention (BHI) is a four-weeks individual intervention, consisting of four sessions: two face-to-face sessions (1-hour) and two telephone follow up sessions (30 minutes) in between.
~The facilitator will guide participants to imagine how they navigate themselves to circumvent possible obstacles and accomplished their set goals and experience positive emotions.
~A booklet will be given to the participants for reviewing their planned goals, recording achieved targets and successful experiences."
15935276|NCT03378700|Other|Pre-dialysis Education Group|Pre-dialysis educational class and standard care such as clinic follow up and normal hospital care will be provided. This session is led by clinicians with renal nursing training. The educational class aims at providing information on the treatment modalities for patients with ESRD, signs and symptoms of their illness and the basic advice on the importance of adherence to healthy lifestyle, nutrition and medications. Logistic call and social communication will be offered and initiated by trained nurses in the second week and the third week
15935277|NCT03378674|Drug|Remifentanil Injectable Product|remifentanil: 0,15 mcg/kg/min
15935278|NCT03378661|Drug|Benznidazole|Benznidazole tablet
15935279|NCT03378661|Drug|E1224|E1224 capsules
15935280|NCT03378661|Drug|E1224 Placebo|E1224 matched placebo capsules
15935281|NCT03378661|Drug|Benznidazole Placebo|Benznidazole matched placebo tablets
15935282|NCT03378648|Drug|CHF6366|"Drug: CHF6366 (Part 1 - SAD) Single doses of CHF6366 at each period (for up to 3 periods per subject)
~Drug: CHF6366 (Part 2 - MAD) Once daily doses of CHF6366 for 7 days
~Drug: CHF6366 (Part 3) Single dose of CHF6366"
15935283|NCT03378648|Drug|Placebo CHF6366|"Drug: Placebo (Part 1 - SAD) Single doses of placebo matching CHF6366 at each period (for up to 3 periods per subjects)
~Drug: Placebo (Part 2 - MAD) Once daily dose of placebo matching CHF6366 for 7 days
~Drug: Placebo (Part 3) Single dose of placebo matching CHF6366"
15935284|NCT03378648|Drug|umeclidinium bromide and vilanterol trifenatate|Part 3 Single dose
15935285|NCT03378635|Drug|Dasiglucagon|Glucagon analog
15935286|NCT03378635|Drug|GlucaGen|Native glucagon
15935287|NCT03378635|Drug|Placebo|Placebo for dasiglucagon
15935288|NCT03378622|Other|Anchor|Anchor technique for mesh attachment
15935289|NCT03378622|Other|Suture|Suture technique for mesh attachment
15935290|NCT03378609|Other|Vocal Fatigue Index (VFI)|collection of 190 consecutive data sets, participants give separate consent for participating a retest or an interview, retest will be realised with the 10 following volunteers
15935291|NCT03378596|Dietary Supplement|L-citrulline + L-arginine|L-citrulline + L-arginine - sachet dissolved in water
15935292|NCT03378596|Dietary Supplement|L-arginine|L-arginine - sachet dissolved in water
15935293|NCT03378596|Dietary Supplement|L-citrulline|L-citrulline - sachet dissolved in water
15935294|NCT03378596|Dietary Supplement|Placebo|Placebo (corn starch) - sachet dissolved in water
15935295|NCT03378570|Device|Repetitive transcranial magnetic stimulation|Repetitive transcranial magnetic stimulation will be targeted to a location in the left prefrontal cortex and delivered according to FDA-approved parameters for the treatment of major depressive disorder, specifically high-frequency 10 Hz rTMS for 3000 pulses, 5 days per week for a total number of sessions as deemed clinically appropriate by the patient's clinical TMS treatment team but usually on the order of 20-30 treatments.
15935296|NCT03378544|Behavioral|mhGAP|The intervention will involve psycho-education to patients on the importance of maintaining interest in activities that they used to do, regular sleep cycles, physical activity and social activity
15935297|NCT03378531|Drug|AEB1102|modified human arginase I
15935298|NCT03378505|Behavioral|Mobile App|Purposeful Living Mobile App JOOL to be used daily
15935299|NCT03378505|Behavioral|Reflection|Bi-weekly online reflection question
15935300|NCT03378492|Device|Ultrasound Guided Epidural|Sterile ultrasound gel will be applied to the patient's back and the sterile device will be used to image the lumbar vertebrae in the area of the palpation-derived location. When the device is placed above the vertebral interspace, the 3D image mode will identify the spine midline and the depth from the skin to the epidural space. A single 3D ultrasound video loop of the vertebral interspace will be saved to confirm correct landmark identification. After identification of the vertebral interspace, the skin will be marked with a marking utensil or physical indentation at the point of needle entry indicated by the device. The epidural needle will then be placed in the same fashion as in the standard procedure group. The depth of the epidural needle placement will be measured and recorded following observation of loss of resistance.
15935301|NCT03378492|Procedure|Standard Epidural|The point of needle entry will be located using the landmarks technique. The specific level of epidural placement will be determined on a per-patient basis at the anesthesiologist's discretion. The spine midline will also be palpated to determine the approximate location of an interlaminar space. The needle will then be inserted at the appropriate location determined by the landmarks technique, and successful epidural placement will be confirmed by observation of loss of resistance and follow-up confirmation of analgesia. The depth of the epidural needle placement will be measured and recorded following observation of loss of resistance. The epidural catheter will be inserted and the procedure will continue according to the standard of care.
15935302|NCT03378479|Drug|SOC +Posaconazole 18 MG/ML (milligram/milliliter)|.2*300mg/d IV on day 1, followed by 1*300mg/d IV from day 2 for 7 days (total 7 days)
15935303|NCT03378479|Other|standard of care (SOC)|treatment for influenza pneumonia at the investigators discretion
15935304|NCT03378466|Drug|Unfractionated heparin|UFH initiated at 18 IU/kg/hr, dosed according to total body weight and pragmatically adjusted according to local institutional policy to achieve an activated partial thromboplastin (aPTT) of 1.5 to 2.5 times that of the reference aPTT value or anti-Xa values targeted to local practice levels. Duration of study intervention will be a maximum of 5 days (120 hours) or until vasopressors have been discontinued for 24 continuous hours. All participants will then receive venous thromboprophylaxis according to local practice.
15935305|NCT03378466|Other|Venous thromboprophylaxis (VTE)|May include subcutaneous heparin or dalteparin, sequential compression device or graduated compression stockings
15935306|NCT03378453|Device|PET-scan18F-AV-45|The PET-scan18F-AV-45 is a PET-scan dedicated to analyze the amyloid load in the brain with the AV45 tracer by the measurement of the mean cortical SuVr
15935307|NCT03378453|Device|PET-scan18F-AV-45|PET-scan18F-AV-45 already done in another protocol MEMENTO-AMYging
15935308|NCT03378427|Drug|Tedizolid Phosphate 200 MG [Sivextro]|Antibiotic treatment (monotherapy or combination) targeting bacteria cultured from per operative samples.
15935309|NCT03378414|Procedure|Intravenous infusion|Intravenous infusion of mesenchymal stem cells: 2 * 10^7 cells (30ml)
15935310|NCT03378414|Procedure|Intrathecal injection|Intrathecal injection of mesenchymal stem cells: 2 * 10^7 cells (1ml)
15935311|NCT03378414|Biological|umbilical cord mesenchymal stem cell|Treat patients with umbilical cord mesenchymal stem cell (SCLnow 19#), the dosage based on different procedure
15935312|NCT03378401|Drug|Octenidinedihydrochlorid|Mouth rinsing of the oral cavity with Octenidinehydrochlorid vs.Placebo over a period of 5 days
15935313|NCT03378401|Other|Placebo|Mouth rinsing of the oral cavity with Octenidinehydrochlorid vs.Placebo over a period of 5 days
15935314|NCT03378375|Other|nutritional assessement|
15935315|NCT03378362|Procedure|Partial denervation of the wrist joint|Partial denervation of the wrist (posterior and anterior interosseous neurectomy) through a single dorsal approach.
15935316|NCT03378349|Behavioral|Internet-delivered cognitive behavior therapy|The intervention lasts for 10 weeks and include: Education, Interoceptive exposure, exposure in-vivo, combining in-vivo exposure with interoceptive exposure, behavioral activation and relapse prevention. Include the guidance of a minimum weekly contact with a CBT psychologist.
15935317|NCT03378349|Behavioral|Treatment as usual|Consist of standardized AF information that emphasizes that an active physical and social lifestyle is necessary to maintain good health, without the guidance of a psychologist or any CBT interventions.
15935318|NCT03378323|Drug|Multiple injection local anesthetic|Multiple injection local anesthetic
15935319|NCT03378323|Drug|Single injection local anesthetic|Single injection local anesthetic
15935320|NCT03378310|Drug|BMS-986205 reference tablet|Single, 100 mg oral dose.
15935321|NCT03378310|Drug|BMS-986205 tablet with free base|Single, 100 mg oral dose.
15935322|NCT03378297|Drug|Metformin|Metformin tablets 850 mg x 2 orally
15935323|NCT03378297|Drug|Acetylsalicylic acid|Acetylsalicylic acid tablets 160 mg x1 orally
15935324|NCT03378297|Drug|Olaparib|Olaparib capsules 300 mg x 2 orally
15935325|NCT03378297|Drug|Letrozole|Letrozol tablets 2.5 mg x 1 orally
15935326|NCT03378284|Drug|Tegoprazan|Tegoprazan QD for 7 days
15935327|NCT03378284|Drug|Revaprazan|Revaprazan QD for 7 days
15935328|NCT03378271|Device|Simultanious CGM/FGM|Patients will use both CGM and FGM and document their values as well as documenting a capillary blood glucose value.
15935329|NCT03378245|Behavioral|Behavioral modification and education on pharmacologic treatments.|Education and counseling of care-giving staff on behavioral modification strategies, as well as education about current standard of care best practices for pharmacologic interventions.
15935330|NCT03378232|Dietary Supplement|Placebo Olive Oil|Each participant was instructed to consume the dietary supplement on a daily basis for 12 weeks.
15935331|NCT03378232|Dietary Supplement|High EPA Supplement|Each participant was instructed to consume assigned dietary supplement on a daily basis for 12 weeks.
15935332|NCT03378232|Dietary Supplement|High DHA Supplement|Each participant was instructed to consume assigned dietary supplement on a daily basis for 12 weeks.
15935333|NCT03378219|Drug|Sarilumab SAR153191 (REGN88)|Pharmaceutical form:injection Route of administration: subcutaneous
15935334|NCT03378206|Device|hinged 8-figure plate|Hinged 8-figure plate has two arms and a built-in hinge. The rotation of the two arms ranged from 155° to 170° to better fit the contour of the physis in all stages of angular correction. That automatic change can also disperse repeated stress on the surface of periosteum and perichondrium during walking.
15935335|NCT03378206|Device|conventional 8-figure plate|Conventional 8-figure plate is a widespread device to treat angular deformity of lower limbs with moderate successful rate. The device was designed based on the principle of tension band model. It consists of a plate and two screws (epiphyseal screw and metaphyseal screw).
15935336|NCT03378167|Biological|MICROBIOTA|Fecal microbiota enema (RBX2660) infused via colonoscope x 1 + oral microbiota capsules (RBX7455) x 6 weeks. The fecal microbiota enema (RBX2660) prepared by Rebiotix has received Health Canada Clinical Trials Application (CTA), and U.S. Food and Drug Administration Investigational New Drug Application (IND) approval for clinical trials in patients with recurrent Clostridium difficile infection, and pediatric inflammatory bowel disease. The human-derived fecal oral microbiota capsule (RBX7455) has received U.S. Food and Drug Administration Investigational New Drug Application (IND) approval for clinical trials in patients with recurrent Clostridium difficile infection.
15935337|NCT03378167|Biological|PLACEBO|"Placebo enema (Normal Saline) infused via colonoscope x 1 + oral placebo capsules (dextrose-containing capsules) x 6 weeks.
~NOTE: Patients randomized to the control group will be given the option of receiving open-label treatment, with the intervention therapy, either: upon completion of the trial, or if they are removed from the trial due to disease exacerbation or other adverse event, at the discretion of their primary gastroenterologist."
15935338|NCT03378154|Procedure|Orotracheal intubation in infants with Macintosh|Orotracheal intubation in infants using Macintosh laryngoscope
15935339|NCT03378154|Procedure|Orotracheal intubation in infants with King vision|Orotracheal intubation in infants with King vision videolaryngoscope
15935340|NCT03378141|Behavioral|Maternal Nutrition Behavior change|Counseling and community mobilization
15935341|NCT03378128|Procedure|Diagnostic laparoscopy|The patient will initially undergo a diagnostic laparoscopy by a minimally invasive approach and entry method. The decision of which approach and entry to perform will be dictated by the primary surgeon of record's preference and their assessment of pre-operative patient factors. Once the primary surgeon determines the areas of macroscopic disease, he/she will make an assessment as to the need to convert to a laparotomy or continue laparoscopically. At the completion of the procedure, it will be noted whether an optimal cytoreduction (≤ 1 cm residual disease) or a sub-optimal cytoreduction (>1 cm residual disease) was performed.
15935342|NCT03378102|Biological|IFN-gamma-secreting HAdV antigen specific T cells|Antigen selected cells will be obtained using the CliniMACS(R) Prodigy System from a compatible donor. Isolated cells will be infused into the donor to treat human adenoviral infection after transplant
15935343|NCT03378089|Behavioral|Music Therapy|No narcotic or anti-emetic therapy will be administered for at least 2 hours prior to music therapy session. Music therapy sessions will be administered by a board certified music therapist (MT-BC) and last approximately 45 minutes. Involvement in sessions will be based on therapist and patient availability.
15935344|NCT03378089|Behavioral|No Music Therapy|Participants will fill the same 45 minute period in any way they choose; however, they will be asked to refrain from listening to recorded music during this time.
15935345|NCT03378076|Drug|FX006 32 mg|Drug: Extended-release 32 mg FX006 IA injection into each knee (total 64 mg dose)
15935346|NCT03378076|Drug|TAcs 40 mg|Drug: Immediate-release 40mg TAcs IA injection into each knee (total 80 mg dose)
15935347|NCT03378063|Drug|transplantation of mesenchymal stem cell|allogeneic human umbilical cord blood (hUCB)-derived mesenchymal stem cell (MSC) transplantation will be given to preterm infants
15935348|NCT03378063|Drug|no transplantation of mesenchymal stem cell|MSC transplantation will be not given to preterm infants
15935349|NCT03378050|Behavioral|HEART|"The intervention group will receive a multi-component individualized support intervention HEART, which will consist of 12 sessions in four stages. By using a comprehensive assessment targeting five components, an individualized intervention plan will be developed to address identified problems and unmet needs. Those five components consist of: Health, Emotion, Activities, Resources and Training."
15935350|NCT03378050|Other|Usual Care|"Caregivers in the control group will receive 12 week follow-up as usual (FU) including two brief check-in calls and an outcome measures call during the study period."
15935351|NCT03378037|Procedure|Acupuncture|20 minutes of acupuncture treatment, twice a week for 2 weeks. Acupoints will be manually stimulated every 10 minutes.
15935352|NCT03378024|Device|oscillometric (Omron Colin co)|fast measurements of the brachial-ankle pulse wave velocity (baPWV) and the resting ankle-brachial index(ABI) with the oscillometric method (Omron Colin co, Japan)
15935353|NCT03378011|Other|phototherapy|phototherapy either UVA1 or topical PUVA on acral vitiligo
15935354|NCT03377998|Other|skin biopsy|Skin biopsy for measuring tissue levels of the Erythroid differentiation regulator 1 (Erdr1) cytokine will be taken from the lesional skin of patients of vitiligo and from normal skin of healthy controls.
15935355|NCT03377985|Procedure|brachial plexus block|
15935356|NCT03377959|Other|Pilates Mat Classes|The intervention, the exercises, and their progressions were systematized based on protocol proposed by Siler (2008).
15935357|NCT03377959|Other|Ballet Classes|The intervention is ballet classes three times a week, 1 hour and 30 min. The ballet classes consists in barre work and center work with specific ballet exercises.
15935358|NCT03377946|Biological|probiotics|the probiotics group was taking probiotics 4 packets a day
15935359|NCT03377946|Biological|placebo|the placebo group was taking placebo 4 packets a day
15935360|NCT03377933|Other|Compound Lactobacillus acidophilus|Compound Lactobacillus acidophilus Tablet
15935361|NCT03377920|Device|In-check Dial device (Clement Clarke International Ltd, Harlow, UK)|"pre-bronchodilator spirometry for the measurement of PIFspiro as per ERS/ATS guidelines for standard lung function5 (part of routine clinical follow-up).
~5 forced inspiratory manoeuvres using the In-check Dial device G16, set at 5 different resistances (performed in order of increasing resistance), yielding the PIFresist values for the different DPI's"
15935362|NCT03377907|Drug|ketamine in hematoma block|ketamine used in local hematoma block only
15935363|NCT03377907|Drug|ketamine in local intravenous anesthesia|ketamine will be used with lidocaine in local intravenous anesthesia
15935364|NCT03377907|Drug|Lidocaine Hydrochloride|2.5 mg/kg of lidocaine 2% in intravenous regional anesthesia
15935365|NCT03377894|Procedure|blunt uterine incision expansion|blunt uterine incision expansion
15935366|NCT03377894|Procedure|sharp uterine incision expansion|sharp uterine incision expansion
15935367|NCT03377881|Procedure|MRI/Fusion biopsies|The intervention in the experimental arm is an MRI with targeted biopsies using fusion technique to prostate lesions.
15935368|NCT03377881|Procedure|Systematic biopsies|The intervention in the control arm is traditional systematic biopsies of the prostate.
15935369|NCT03377868|Diagnostic Test|Optic coherence tomography|Optic coherence tomography measures retinal layer thickness, macular volume , and cell inner plexiform layer.
15935370|NCT03377868|Diagnostic Test|Pulmonary function test|Pulmonary function test measures forced vital capacity and forced expiratory volume in one second.
15935371|NCT03377855|Other|Default Prescribing Change|In the e-prescribing system, the default opioid dosage/duration is changed to the minimum recommended dosage from the CDC guidelines for short acting opioids.
15935372|NCT03377842|Drug|FOLFOX regimen|FOLFOX(Oxaliplatin 85 mg/m² IV infusion and leucovorin 200 mg/m² IV infusion， followed by Fluorouracil 400 mg/m² IV bolus , followed by Fluorouracil 600 mg/m²/h IV infusionas a 22-hour continuous infusion). Repeat cycle every 2 weeks for a total of 6 cycl
15935373|NCT03377842|Drug|apatinib and FOLFOX regimen|Apatinib, 500mg p.o. qd, Repeat cycle every 2 weeks for a total of 6 cycles. FOLFOX regime, Repeat cycle every 2 weeks for a total of 6 cycles.
15935449|NCT03377322|Drug|Placebo Capsule|Placebo - one capsule a day for four weeks
15935450|NCT03377309|Drug|Fycompa|Dose will be increased by 2mg/day increments every one week to reach a maximum dose of 8 mg/day. Treatment phase will be stable dose for 12 weeks then followed by washout period over 2 weeks.
15935566|NCT03376516|Drug|Wilate|von Willebrand factor / Factor VIII (plasma derived)
15935374|NCT03377829|Procedure|PLA|During the PLA, the patient is in supine position with head extended: the physician, ultrasound assistant and trained nurse work within the sterile field. Under constant ultrasound image guidance and after local anesthesia by means of 2% xylocaine infiltration, thin needles (21G) are positioned in the thyroid lesion, within safety distance from the surrounding anatomical structures. A plane-cut tip fiber optics is inserted into the PTMC through the needle. The laser at 1064 nm wavelength is turned on for 10 minutes until the pre-established energy dose is attained. There is usually no pain or very limited pain.
15935375|NCT03377829|Procedure|Thyroid Surgery|Patients are routinely disinfected and spread the drapes after general anesthesia. Neck skin, fat, placenta muscle are incised successively. The flap is separated to the upper edge of thyroid cartilage, neck white line is incised and anterior muscle group is separated. Then both sides thyroid lobes are exposed. Cut off the isthmus, ligature the thyroid artery, cut off the upper pole. Ligature and cut off the ipsilateral thyroid vein. Reveal and protect the ipsilateral recurrent laryngeal nerve and the parathyroid gland during the entire process. Finally patient is performed total thyroidectomy or subtotal thyroidectomy.
15935376|NCT03377816|Behavioral|Art Therapy|In a group setting participants will be encouraged to engage in art making for increased emotional awareness, expression, and acceptance. The role of the art therapist is to encourage a non-judgmental and exploratory approach to artmaking in which the process is emphasized over product. The art therapist obtains these goals by creating an atmosphere that is calm and by remaining tuned in to the verbalizations and body language of participants. If needed she can provide individual attention that is geared toward neutralizing concerns regarding performance during the art making.
15935377|NCT03377816|Behavioral|Sham Art Therapy|In a group setting participants will engage in Mandala coloring
15935378|NCT03377803|Drug|VP-102|VP-102 Active will be administered via the applicator to Molluscum lesions
15935379|NCT03377803|Drug|Placebo|Placebo to be applied via the applicator to Molluscum lesions
15935380|NCT03377803|Device|Applicator|Used to apply the topical film forming Active or Placebo to Molluscum.
15935381|NCT03377790|Drug|VP-102|VP-102 Active will be administered via the applicator to Molluscum lesions
15935382|NCT03377790|Drug|Placebo|Placebo to be applied via the applicator to Molluscum lesions
15935383|NCT03377790|Device|Applicator|Used to apply the topical film forming Active or Placebo to Molluscum.
15935384|NCT03377777|Other|No intervention|
15935385|NCT03377764|Procedure|Landmark Technique Control group|Spinal Anesthetic
15935386|NCT03377764|Procedure|Neuroaxial block using Ultrasound Guidance|Ultrasound guided Spinal Anesthetic
15935387|NCT03377751|Procedure|Additional posterior wall isolation|"PVI and additional posterior wall isolation will be performed according to the following protocol which is based on low voltage area.
~Proportion of low voltage area to area of left atrium body <10% : PVI only
~Proportion of low voltage area to area of left atrium body ≥10% : PVI + Posterior wall isolation
~Low voltage area will be measured from more than 1000 points of sampled voltage value during sinus rhythm using PentaRay catheter with 3D mapping system of CARTO (Biosense Webster, CA, USA)."
15935388|NCT03377751|Procedure|Voltage-guided substrate homogenization|"PVI and additional substrate modification at low voltage areas will be performed according to the following protocol which is based on low voltage area.
~Proportion of low voltage area to area of left atrium body <10% : PVI only
~Proportion of low voltage area to area of left atrium body ≥10% : PVI + substrate homogenization at low voltage areas
~Low voltage area will be measured from more than 1000 points of sampled voltage value during sinus rhythm using PentaRay catheter with 3D mapping system of CARTO (Biosense Webster, CA, USA)."
15935389|NCT03377751|Procedure|PVI only group|PVI will be performed in this arm.
15935390|NCT03377738|Diagnostic Test|spirometry|All patients will be given an intervention for tobacco cessation which will depend on the individual's cessation phase and will be given a spirometry test as a motivational element for dishabituation.
15935391|NCT03377725|Drug|Decitabine|20mg/m^2,d1-5,ivgtt,28days as a duration
15935392|NCT03377725|Drug|Arsenic Trioxide|0.16mg/kg,d1-5,ivgtt,28days as a duration
15935393|NCT03377712|Device|optoelectronic plethysmography|Evaluates the thoracoabdominal kinematics and the ventilatory pattern of the patient through the filming with cameras, simple and non-invasive examinations
15935394|NCT03377712|Device|diaphragmatic ultrasound|Evaluates the diaphragmatic mobility through images, simple and non-invasive use
15935395|NCT03377712|Device|Postural evaluation|Evaluates the patient's posture through photos and filming, rapid examination, simple and non-invasive
15935396|NCT03377712|Device|Pain evaluation|by means of questionnaires
15935397|NCT03377712|Device|Evaluation of the function|through questionnaires
15935398|NCT03377712|Device|Functional capacity assessment|Evaluated through the six-minute walk test, where the patient walks along a 30-meter corridor, simple, fast and safe assessment
15935399|NCT03377712|Device|Quality of life assessment|through questionnaire
15935400|NCT03377699|Drug|Insulin degludec|Injection for subcutaneous (s.c., under the skin) use once daily. The total trial duration for subjects will be maximum 25 months
15935401|NCT03377699|Drug|Insulin Aspart|Injection for subcutaneous (s.c., under the skin) use 2-4 times daily with meals. The total trial duration for subjects will be maximum 25 months
15935402|NCT03377699|Drug|Insulin detemir|Injection for subcutaneous (s.c., under the skin) use, once daily or twice daily. The total trial duration for subjects will be maximum 25 months
15935403|NCT03377686|Diagnostic Test|inflammation markers in exhaled breath|non-invasive, cross-sectional, assessment of inflammation markers in exhaled breath with various techniques (observational)
15935404|NCT03377673|Diagnostic Test|CMR|CMR is performed using a 1,5T whole-body system (Siemens Aera, Siemens Medical Solutions; Erlangen, Germany)
15935405|NCT03377660|Other|Clinical treatment|Patients undergo clinical treatment as indicated, they are studied before and after.
15935406|NCT03377647|Behavioral|Asthma Care Provider Training|In this intervention, asthma care providers will be trained in current, evidence-based guidelines for care of children with asthma, and will be provided with tools that their practice may use to facilitate care improvements.
15935407|NCT03377647|Behavioral|School Staff Asthma Education|In this intervention, teachers and other school staff will be provided current, evidence-based training in understanding asthma and will be provided tools to help schools address the special needs of children with asthma.
15935408|NCT03377634|Behavioral|MORPH|Participants will engage in 12 weekly group coaching sessions discussion behavioral approaches to pain management, weight loss, and daily physical activity. The first three sessions (i.e., weeks 1 - 3) will occur in-person, and the remaining 9 will take place via telephone. All intervention participants will receive access to an activity monitor, smart scale, and smartphone app that aims to provide support for daily physical activity and weight loss.
15935409|NCT03377621|Device|Whole Body Vibration|Whole Body Vibration Machine from the company Confidence Fitness
15935410|NCT03377608|Drug|Tenofovir Disoproxil Fumarate|Two cervical biopsies, blood plasma, PBMC, urine, and two cervicovaginal swabs will be collected at a single study visit
15935411|NCT03377608|Drug|Depo-Provera|Two cervical biopsies, blood plasma, PBMC, urine, and two cervicovaginal swabs will be collected at a single study visit
15935412|NCT03377595|Drug|Exparel|TAP (Transversus Abdominis Plane) block
15935413|NCT03377595|Drug|Exparel|Wound infiltration
15935414|NCT03377582|Other|Exercise|Both interventions uses exercises
15935415|NCT03377569|Other|Sleep, PD and DBS|Sleep, PD and DBS
15935416|NCT03377556|Other|Laboratory Biomarker Analysis|Correlative studies
15935417|NCT03377556|Other|Pharmacological Study|Correlative studies
15935418|NCT03377556|Drug|Talazoparib|Given PO
15935419|NCT03377543|Drug|Aspirin|81mg aspirin pill daily at bedtime over a 25 day period
15935420|NCT03377543|Drug|Placebo|81mg non-active pill that looks like aspirin
15935421|NCT03377530|Diagnostic Test|Ways to prevent these infections.|"The purpose of this database is to describe the pathogenicity of this germ, the incriminated modes of contamination.
~The collaborators studied the factors of poor prognosis and propose ways to prevent these infections."
15935422|NCT03377517|Radiation|radiosurgical hypophysectomy|Patients will be treated to a dose of 150 Gy in a single fraction. All patients will undergo CT simulation with 1 mm slices as well as MRI simulation including at least high resolution 1 mm slice T1 weighted MRI. They will be treated in a supine position using an aquaplast mask system for immobilization.
15935423|NCT03377504|Behavioral|mirror therapy|Mirror therapy will include wrist flexion/extension, ulnar/radial deviation, hand finger flexion/extension and abduction/adduction, thumb abduction/adduction/opposition, and forearm supination/pronation movements as well as various object grasping activities according to the status of the patient's hand functions.
15935424|NCT03377504|Behavioral|Routine physical therapy and exercise program|Routine physical therapy and exercise program including contrast baths, hot pack, TENS, desensitization, exercises and occupational therapy will be applied to all patients
15935425|NCT03377491|Device|NovoTTF-100L(P)|Patients receive continuous TTFields treatment using the NovoTTF-100L(P) device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the torso. The treatment enables the patient to maintain regular daily routine.
15935426|NCT03377491|Drug|Gemcitabine|Gemcitabine 1000 mg/m^2 over 30 minute infusion will be administered immediately after nab-paclitaxel on Days 1, 8 and 15 of each 28-day cycle.
15935427|NCT03377491|Drug|nab paclitaxel|nab-paclitaxel 125 mg/m^2 administered as an intravenous infusion over 30-40 minutes on Days 1, 8 and 15 of each 28-day cycle.
15935428|NCT03377478|Drug|Epclusa|Patients testing positive for HCV viremia will receive 12 weeks of Epclusa.
15935429|NCT03377465|Diagnostic Test|ADMA (asymmetric dimethylarginine) , NTproBNP (N-terminal pro b-type natriuretic peptide), IL-6 (Interleukin 6), Adiponectina, Leptine, Syndecan, Resistin|ADMA, NTproBNP, IL-6, Adiponectina, Leptine, Syndecan, Resistin
15935430|NCT03377452|Behavioral|Behavioral Education Intervention I|Manual-based education program focusing on sleep and sleep apnea provided in individual sessions.
15935431|NCT03377452|Behavioral|Behavioral Education Intervention II|Manual-based education program focusing on sleep and sleep apnea provided in individual sessions.
15935432|NCT03377439|Other|Platelet function tests|Platelet reactivity was measured by flow cytometry, filopodia detection and the platelet aggregation analyzer.
15935433|NCT03377426|Drug|LYS228|LYS228 IV infusion
15935434|NCT03377426|Drug|Standard of care therapy|IV infusion of standard of care antibiotics
15935435|NCT03377400|Drug|Durvalumab|concurrent radiotherapy
15935436|NCT03377387|Drug|Capecitabine|Capecitabine will be taken orally in AM and PM (at the assigned dose per cohort) 7 days on and 7 days off. Phase II MD 1000mg BID of capecitabine.
15935437|NCT03377387|Drug|Neratinib|Neratinib is given as 240 mg daily continuously without stopping. A cycle is 28 days. Phase II The MD has been determined as 240mg of neratinib
15935438|NCT03377387|Behavioral|EORTC QLQ - BR23, EQ-5D-5L, EORTC QLQ-C30|Questionnaires Every Cycle (+/- 3 days) (For phase II)
15935439|NCT03377374|Dietary Supplement|Probiotic|L. reuteri Prodentis oil drops (L. reuteri DSM 17938 and L. reuteri ATCC PTA 5289) will be given at a dose of 2x108 Colony Forming Units (CFU). Five drops are to be taken twice a day (in the morning and in the evening) giving a daily dose of 4x108 CFU/day.
15935440|NCT03377374|Other|Placebo|Five drops of Placebo taken twice a day (in the morning and in the evening).
15935441|NCT03377361|Biological|Nivolumab|Specified dose on specified days
15935442|NCT03377361|Drug|Trametinib|Specified dose on specified days
15935443|NCT03377361|Biological|Ipilimumab|Specified dose on specified days
15935444|NCT03377361|Drug|Regorafenib|Specified dose on specified days
15935445|NCT03377348|Procedure|intraoperative subconjunctival injection of triamcinolone acetonide and limited peritomy during bare scleral pterygium excision|intraoperative subconjunctival injection of triamcinolone acetonide and limited peritomy during bare scleral pterygium excision
15935446|NCT03377335|Drug|Dapagliflozin 10mg|"The subjects in this arm will receive dapagliflozin (10mg daily) as add-on to metformin therapy (doses ranging from 1500 to 3000 mg daily).
~Number of patients to be randomized: 93
~Number of patients expected to complete the study: >87
~All the other medications (including lipid-lowering, anti-hypertensive and anti-platelet agents) will be maintained at fixed doses during the treatment."
15935447|NCT03377335|Drug|Metformin|"All the subjects in this arm will be on metformin therapy only (doses ranging from 1500 to 3000 mg daily).
~Number of patients to be randomized: 93
~Number of patients expected to complete the study: >87
~All the other medications (including lipid-lowering, anti-hypertensive and anti-platelet agents) will be maintained at fixed doses during the treatment."
15935448|NCT03377322|Drug|Probiotic Capsule|Probiotic - one capsule a day for four weeks
15935451|NCT03377296|Other|Plasmodium vivax infection|Two healthy human volunteers are exposed to the bites of five infectious mosquitoes per participant (by placing their forearms over the pot containing mosquitoes) for 5-10 minutes. Fed mosquitoes (as indicated by the presence of a blood meal in the abdomen) are individually dissected and assessed for sporozoite load (graded 0 to +4; a gland rating of +2 or more, representing 10 or more observed sporozoites, qualifies as being infectious). If, by this method the volunteer is found to have been inoculated by less than five infected mosquitoes, further mosquitoes are allowed to feed on the volunteer until a total of 5 appropriately infected mosquitoes have fed. The bite-challenge procedure continues until the subject has been bitten by 5 infectious mosquitoes.
15935452|NCT03377296|Procedure|Collection of 250mL blood from each volunteer (N=2)|Collection of 250mL of P. vivax-infected blood from each volunteer when a threshold parasitaemia/ symptoms are met
15935453|NCT03377283|Biological|organ perfusion with rabbit anti-thymocyte globulin (rATG)|
15935454|NCT03377283|Other|organ perfusion with saline|
15935455|NCT03377270|Behavioral|Respiratory Swallow Training|Training in the Optimal Respiratory Swallow Pattern and Lung Volume at Swallow Initiation
15935456|NCT03377257|Drug|zolmitriptan by sublingual administration|Experimental group
15935457|NCT03377257|Drug|zolmitriptan by oral|Active group
15935458|NCT03377244|Behavioral|HBHS|Faith based diabetes curriculum that teaches participants to connect faith and health plus church-level policy changes that encourages participants to engage in healthy behaviors.
15935459|NCT03377244|Behavioral|HBHS Policy|Church-level policy changes that encourages participants to engage in healthy behaviors.
15935460|NCT03377244|Behavioral|WORD DPP|Faith based diabetes curriculum that teaches participants to connect faith and health.
15935461|NCT03377231|Device|Stratamark®|Film-forming dressing for the prevention and treatment of stretch marks.
15935462|NCT03377218|Dietary Supplement|Iodine|Receiving 150 μg iodine (as potassium iodide) daily
15935463|NCT03377218|Dietary Supplement|Iodine + Selenium|Receiving a combination of 150 μg iodine (as potassium iodide) and 100 μg selenium daily
15935464|NCT03377205|Device|Compression screws and neutralization plate|Open reduction and internal fixation with screws and plate
15935465|NCT03377205|Device|Acumed Fibular Rod System|intramedullary nailing of fibula
15935466|NCT03377179|Drug|ABC294640|Two 250 mg capsules of ABC294640 will be taken twice daily
15935467|NCT03377179|Drug|Hydroxychloroquine Sulfate 200 MG|HCQ tablets will be taken at a dose that will be determined
15935468|NCT03377166|Diagnostic Test|Bucket test and Smartphone-based evaluation of SVV|Bucket test and Smartphone-based evaluation of SVV
15935469|NCT03377153|Dietary Supplement|hesperidin and flaxseed|2 capsuls hesperidin and 30 g flaxseed
15935470|NCT03377153|Other|control|no supplementation
15935471|NCT03377140|Dietary Supplement|Hesperidin|2 capsuls
15935472|NCT03377140|Other|control|2 capsuls
15935473|NCT03377127|Behavioral|Pharmacy Managed Diabetes Clinic (PMDC)|The PMDC visit encounters will focus on patient identified goals for the management of their diabetes. Initial visit in the PMDC will be 60-90 minutes with follow up visits lasting 30-45 minutes.
15935474|NCT03377127|Other|Standard of Care (SOC)|Standard of care will be delivered at the physician discretion per the current American Diabetes Association recommendations
15935475|NCT03377114|Procedure|Neutral|When inserting a tracheal tube to oral cavity via nostril before use of laryngoscope in nasotracheal intubation, clinicians advance the tube with patient' head and neck in neutral position.
15935476|NCT03377114|Procedure|Head tilting|When inserting a tracheal tube to oral cavity via nostril before use of laryngoscope in nasotracheal intubation, clinicians advance the tube with patient' head in head-tilting position.
15935477|NCT03377101|Drug|Copanlisib|Given IV
15935478|NCT03377101|Drug|Fulvestrant|Given IM
15935479|NCT03377101|Other|Laboratory Biomarker Analysis|Correlative studies
15935480|NCT03377101|Drug|Palbociclib|Given PO
15935481|NCT03377088|Other|Rose oil|Rose oil will be given as the intervention in this study, an over-the-counter agent that can be commonly found in retail stores. It will be delivered as 2 drops 50% rose oil in water on a cotton ball within 20 cm of the patient's face for 30 minutes.
15935482|NCT03377088|Other|Almond Oil|Almond Oil has been shown in limited studies to act as a placebo for pain control when compared to Rose Oil. This subtly sweet oil will be used to ensure the patient always receives a smell, and maintains blinding.
15935483|NCT03377075|Device|AL measurement|IOL Master 500 (Carl Zeiss AG, Germany)
15935484|NCT03377075|Device|OCT|Choroidal and retinal thickness measurement (DRI OCT-1 Model Triton (plus), Topcon, Tokyo, Japan)
15935485|NCT03377062|Diagnostic Test|EEG monitoring|Five-minute of EEG monitoring accompanied with auditory stimulation.
15935486|NCT03377049|Drug|Acetazolamide|1 g acetazolamide through a peripheral IV line
15935487|NCT03377036|Diagnostic Test|DBT+s2D|Digital breast tomosynthesis plus synthesized 2D mammograms
15935488|NCT03377036|Diagnostic Test|2D-FFDM|2D full-field digital mammography
15935489|NCT03377023|Drug|Nivolumab|Intravenous nivolumab every 2 weeks.
15935490|NCT03377023|Drug|Ipilimumab|Intravenous ipilimumab every 6 weeks.
15935491|NCT03377023|Drug|Nintedanib|Nintedanib 100-200 mg capsules by mouth twice daily for two-week cycles.
15935492|NCT03377010|Other|Dietary intake -Food Frequency Questionnaire|Dietary intake will be assessed using 2014 full-length food frequency questionnaire. The Block 2014 questionnaire combines a full-length food frequency questionnaire with a brief physical activity screening tool. The food and beverage list includes 127 items in the past 1 month, plus additional questions to adjust for fat, protein, carbohydrate, sugar, and whole grain content.
15935493|NCT03377010|Other|Receptivity to Participating in Diet Interventions|Study participants will rate their interest in learning more about dietary interventions to stay healthy using items developed specifically for this study. The items will be rated on a 3-point Likert-type scale from 3 (extremely interested) to 1 (not at all interested).
15935494|NCT03376997|Drug|Perampanel|IV infusion
15935495|NCT03376997|Drug|Perampanel|Oral tablet
15935496|NCT03376984|Combination Product|ND and AMOX modified Gutta Percha|Gutta percha reinforced and modified with 5 nm diameter nanodiamonds and amoxicillin
15935527|NCT03376789|Drug|MYL-1501D|Process V or Process VI
15935528|NCT03376776|Procedure|Vitrectomy|
15935497|NCT03376984|Device|Gutta Percha|Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools. Gutta percha is classified as Class I (general controls).
15935498|NCT03376971|Procedure|Biopsy|Undergo lung biopsy
15935499|NCT03376971|Other|Laboratory Biomarker Analysis|Correlative studies
15935500|NCT03376958|Drug|Apatinib|Apatinib, a novel small molecule vascular endothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor, have shown remarkable efficacy in many solid cancers. The result of our study presented that apatinib might have a rapid, safe and high efficacy on lymphoma patients.
15935501|NCT03376945|Drug|trail cohort|"Drug: Omega-3 Fatty Acid-Based Parenteral Nutrition Glucose, lipid emulsion, amino acids, fat-and water-soluble vitamins as well as electrolytes were compounded in an All-In-One manner. 20% Structolipid and 10% Omegaven (ω-3 fatty acid [FA] mainly; Fresenius-Kabi, Germany) were applied to the trial group, but only Structolipid (ω-6 FA mainly) to the control group for 5 consecutive days postoperatively."
15935502|NCT03376945|Drug|control cohort|"Drug: Structolipid Glucose, lipid emulsion, amino acids, fat-and water-soluble vitamins as well as electrolytes were compounded in an All-In-One manner. 20% Structolipid and 10% Omegaven (ω-3 FA mainly; Fresenius-Kabi, Germany) were applied to the trial group, but only Structolipid (ω-6 FA mainly) to the control group for 5 consecutive days postoperatively."
15935503|NCT03376932|Drug|FF/UMEC/VI|FF/UMEC/VI will be given as dry white powder delivered via the ELLIPTA DPI once daily in the morning or evening. The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 100 mcg or 200 mcg in each blister and the second strip contains UMEC 62.5 mcg and VI 25 mcg in each blister.
15935504|NCT03376932|Drug|FP/SAL|FP/SAL will be given as dry white powder delivered via the DISKUS DPI twice daily in the morning or evening. The DISKUS DPI holds a single blister strip with 60 blisters, which contains FP 250 mcg or 500 mcg and SAL 50 mcg per blister.
15935505|NCT03376932|Drug|Tiotropium|TIO will be given as clear, colorless, inhalation solution delivered via RESPIMAT inhaler once daily in the morning or evening. The RESPIMAT inhaler will contain 60 puffs with 2.5 mcg TIO per puff.
15935506|NCT03376932|Drug|Albuterol/salbutamol|Albuterol/salbutamol will be delivered as a rescue medication via MDI.
15935507|NCT03376932|Device|ELLIPTA DPI|The ELLIPTA device will be used to administer FF/UMEC/VI once daily. The ELLIPTA DPI is a molded plastic two-sided inhaler that can hold two individual blister strips, which contain powder formulation for oral inhalation.
15935508|NCT03376932|Device|DISKUS DPI|The DISKUS device will be used to administer FP/SAL twice daily. The DISKUS DPI is a plastic inhalation delivery system containing a single-foil blister strip of a powder formulation of FP/SAL for oral inhalation.
15935509|NCT03376932|Device|RESPIMAT inhaler|The RESPIMAT inhaler will be used to administer TIO once daily. The RESPIMAT inhaler has a solution filled into a polyethylene/polypropylene cartridge with a polypropylene cap with integrated silicone sealing ring. The cartridge is enclosed within an aluminum cylinder.
15935510|NCT03376932|Device|Metered Dose Inhaler|Albuterol/salbutamol will be delivered as a rescue medication via MDI.
15935511|NCT03376932|Device|Connected Inhaler System|The CIS will consist of a sensor, which clips on to the ELLIPTA DPI. This will inform subject's if/when they have taken their medication that is in the ELLIPTA inhaler. The sensor will measure when the ELLIPTA inhaler mouth piece cover is fully opened and closed and this data can be fed back, via the app on a mobile device to the subject. The sensors, app, and provider portal that provide data are subsequently described as the CIS.
15935512|NCT03376919|Device|CLs++ gait training|CLs++ gait training
15935513|NCT03376906|Procedure|HIIE 1|In the HIIE 1 session, all the subjects performed 10 stimuli of 1 min at high intensity (92% of VO2Max) with passive recovery (without exercise) of 1 min.
15935514|NCT03376906|Procedure|HIIE 3|In the HIIE 3 session, the subjects performed the same stimulus of the HIIE1, but with passive recovery of 3 min. Both protocols started with a warm-up of 5 min at 50% of the VO2Peak performed on a T2-100 GE Healthcare® treadmill (Lynn Medical, Wixon, Michigan, USA).
15935515|NCT03376906|Procedure|Control|In the control session, participants remained seated for 30 min. During HIIE 1 and 2, HR and RPE were assessed immediately after stimulus intervals (ten measurements at each HIIE). In all sessions, the subjects remained in supine position to obtain hemodynamic measurements which were obtained before and at 10 min, 30 min and 60 min after the HIIE and control sessions.
15935516|NCT03376880|Other|1 year follow-up testing|The approach of the study is not in studying the effectiveness of the intervention stimulus, the dose response of diet and exercise, or the rate of weight loss but only the response to 1) weight loss and regular exercise or 2) continued weight gain.
15935517|NCT03376867|Other|Conditioned pain modulation|Conditioned pain modulation (CPM) protocol consist of evaluating pain during two stimuli test (heat and pressure point), before and after one conditioning stimulus (cold water bath); Blood analyses for biochemistry and genes polymorphisms.
15935518|NCT03376854|Device|Hypothermia|Subjects will be cooled using either cooling blankets or gel-pad systems to maintain core temperature 34-35°C.
15935519|NCT03376854|Drug|Neuromuscular Blocking Agents|Subjects in the TH + NMB arm will be deeply sedated using agents at the discretion of the primary ICU team, then start continuous iv infusion of either cisatracurium, atracurium, or vecuronium titrated to 2 twitches on train of four monitoring and further titrated to ablate visible shivering.
15935520|NCT03376854|Device|Standard of Care|Subjects who are hypothermic (≤36°C) during CRRT will receive surface warming to restore core temperature to 37°C. Patients with core temperature >38°C will receive 650 mg acetaminophen and, if temperature remains >38°C, surface cooling will be initiated to return core temperature to 37-38°C.
15935521|NCT03376841|Drug|Cenicriviroc|1 tablet; single-dose oral administration
15935522|NCT03376828|Device|Macintosh laryngoscopy|Endotracheal intubation time using the Macintosh laryngoscope
15935523|NCT03376828|Device|C-Mac Videolaryngoscope|Endotracheal intubation time using the C-Mac Videolaryngoscope
15935524|NCT03376815|Diagnostic Test|landscape sample method|200 cases of different tumor tissues will be compared by traditional sample method and landscape sample method to testify the clinical value and significance of tumor landscape pathological diagnosis .
15935525|NCT03376802|Drug|SAR425899|"Pharmaceutical form: Solution for injection
~Route of administration: Subcutaneous"
15935526|NCT03376802|Drug|Placebo|"Pharmaceutical form: Solution for injection
~Route of administration: Subcutaneous"
15935529|NCT03376763|Drug|Abilify maintena|Switching from oral atypical antipsychotics to long-acting injectable aripiprazole (Abilify maintena)
15935530|NCT03376750|Behavioral|CO - OP|CO-OP is a top-down, task-oriented, client-centered approach that uses an iterative process of dynamic performance analysis and guided discovery to enable individuals to identify strategies that will improve performance
15935531|NCT03376737|Drug|Apatinib|Apatinib (250 mg/d) + Pemetrexed (500 mg/m2)
15935532|NCT03376724|Other|Functional Exercise Protocol|Functional exercise protocol. This protocol started with corporal conscience exercise, breathing, abdominal activation, activities such as sitting, getting up, climbing stairs, reaching with arms, moving forward, bodyweight exercises, bridges and boards. This protocol will be performed during 12 weeks, two sessions per week.
15935533|NCT03376724|Other|Minimal|Analgesic use when necessary and a single back scholl class
15935534|NCT03376711|Behavioral|Online Peer Support Program|"The online peer support program will entail: 1) Informational links; 2) A discussion forum (open to all participants and allowing for asynchronous contact between caregivers & peer mentors); 3) A weekly live chat; 4) Private messaging (audio, video, and text options); and 5) Ask-a-mentor (A short video/blurb profiling each caregiving mentor will be posted including details such as gender, age, duration of care, relationship to care-recipient, and illness that care-recipient suffers from). Caregiving participants can then self-match to a peer mentor they feel is best-positioned to address their support needs."
15935535|NCT03376698|Drug|Colchicine 0.5 mg|oral administration of Colchicine 0.5 mg once daily for 12 weeks
15935536|NCT03376698|Drug|Colchicine 0.25 mg|oral administration of Colchicine 0.25 mg once daily for 12 weeks
15935537|NCT03376698|Drug|Placebo|oral administration of Placebo once daily for 12 weeks
15935538|NCT03376685|Behavioral|Endurance Exercise Training (END)|Physical activity will be conducted on cycle ergometers under supervision. Participants will exercise 5 days a week for 30 minutes (Week 1-2); 35 minutes (Weeks 3-4); or 40 minutes (Weeks 5-6) at 60% VO2 peak.
15935539|NCT03376685|Behavioral|Sprint Exercise Training (SIT)|Physical activity will be conducted on cycle ergometers under supervision. Participants will exercise 3 days a week involving a 3-minute warm-up, followed up 4 repetitions (Week 1-2); 5 repetitions (Weeks 3-4); or 6 (Weeks 5-6) repetitions of 30 seconds at a maximal intensity with 2 minutes' rest in between. Exercise will conclude with a 2-minute cool-down.
15935540|NCT03376672|Drug|Ixazomib|All patients will have similar induction and consolidation treatment with the same regimen.
15935541|NCT03376672|Drug|Lenalidomide|All patients will have similar induction and consolidation treatment with the same regimen.
15935542|NCT03376672|Drug|Dexamethasone|All patients will have similar induction and consolidation treatment with the same regimen.
15935543|NCT03376659|Drug|Durvalumab|750mg IV q2 weeks
15935544|NCT03376659|Biological|CV301|"MVA-BN-CV301 (prime) - two priming doses of 1.6 x 109 infectious units/0.5 mL (Inf.U) given subcutaneously (s.c.)
~FPV-CV301 (boost) - dosed at 1 × 109 Inf.U/0.5 mL given s.c."
15935545|NCT03376659|Drug|Capecitabine|1000mg orally twice a day, Monday - Friday Weekly
15935546|NCT03376659|Drug|Bevacizumab|5mg/kg IV q2weeks
15935547|NCT03376646|Device|Cohort A: Dissolve™|Dissolve™ are to be used in the trial
15935548|NCT03376646|Device|Cohort A: Resolute™ Integrity|Resolute™ Integrity are to be used in the trial
15935549|NCT03376646|Device|Cohort B: Dissolve™-2.00mm|Dissolve™ are to be used in the trial
15935550|NCT03376633|Behavioral|Working on Womanhood (WOW)|A trauma-informed group counseling and clinical mentoring intervention for young women
15935551|NCT03376620|Drug|1,4-Diaminobutane|Daily application to surgical breast scars of 1,4 diaminobutane on the active side
15935552|NCT03376620|Drug|10% Urea cream|Daily application to surgical breast scars of 10% Urea cream on the sham side
15935553|NCT03376607|Other|HBCP programme|The newly-established Home-Based Community Practitioners (HBCPs) programme will enable frontline workers to offer monthly health assessments, disease management and lifestyle advice to diabetic patients, and referral to the district hospitals when needed.
15935554|NCT03376607|Behavioral|mobile health application|"HBCPs will actively encourage the use of a mobile app by assisting patients to access it (this process is known as facilitated access). The app will enable: (i) the registration of measurements, such as blood glucose and weight; (ii) the registration of concerns and questions in a diary; (iii) the reception of alerts and notifications for the appointments to the health facilities, and; (iv) access to advice on lifestyle improvement and other patient educational material."
15935555|NCT03376594|Drug|Benjakul Extract|30 patients taking Benjakul Extract dosage 100 mg capsule 3 times daily. before Breakfast, lunch and dinner for 42 days.
15935556|NCT03376594|Drug|Loratadine|30 patients taking Loratadine dosage 10 mg capsule 3 times daily. before Breakfast, lunch and dinner for 42 days.
15935557|NCT03376581|Procedure|Platelet rich plasma|Blood drawn from each participant will be spun down to separate platelets. Platelets will be injected into that patient's scalp.
15935558|NCT03376555|Drug|Acetylcholine (ACh) Dose Response|Probe 1. Lactated Ringer's only (control) Probe 2. Lactated Ringer's + N-G-nitro-L-arginine methyl ester (LNAME) Probe 3. Lactated Ringer's + Ascorbate Probe 4. Lactated Ringer's + Tempol Probe 5. Lactated Ringer's + Apocynin
15935559|NCT03376555|Drug|Local Heating (LH)|Probe 1. Lactated Ringer's only (control) Probe 2. Lactated Ringer's + Ascorbate Probe 3. Lactated Ringer's + Tempol Probe 4. Lactated Ringer's + Apocynin
15935560|NCT03376555|Drug|Flow Mediated Dilation with nitroglycerin|"BP cuff on a forearm, gel on the upper arm just above the elbow, and a Doppler ultrasound probe on the gel. The ultrasound measures vessel size and blood velocity. After a 3-minute resting measurement, the cuff inflates for 5 minutes to occlude forearm blood flow (BF). After the cuff deflates, we perform a second reading.
~Sublingual nitroglycerin: The subject is supine. We measure blood pressure. Also, we perform ultrasonography at the brachial artery at the elbow during the procedure. Nurse places a 0.4 mg nitroglycerin tablet under the subject's tongue. The subject remains supine for 20 minutes following the nitroglycerin administration."
15935561|NCT03376542|Diagnostic Test|Cardiopulmonary Exercise Testing|Cardiopulmonary exercise testing on treadmill prior to coronary artery bypass grafting surgery
15935562|NCT03376529|Drug|SPR741|400 mg IV over 1 hour
15935563|NCT03376529|Drug|Ceftazidime|1.0 gram IV over 1 hour
15935564|NCT03376529|Drug|Piperacillin/tazobactam|4.5 grams IV over 1 hour
15935565|NCT03376529|Drug|Aztreonam|1.0 gram IV over 1 hour
15935568|NCT03376477|Biological|GM-CSF vaccine|Each vaccination will consist of three total intra-dermal injections, on day 14 of cycles 1, 2, 3, 6 and annually for a minimum of 36 months in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). In the event that the specified limb is contraindicated, the dominant arm may be used. Vaccine injection sites shall be at least 5 cm at needle entry from the nearest neighbor. The approximate volume of each vaccination injection is approximately 0.7-0.8ml.
15935569|NCT03376477|Drug|Lenalidomide|Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5-25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle).
15935570|NCT03376477|Drug|Prevnar13|Prevnar will be administered at the same time points as the GM-CSF vaccine (day 14 of cycles 1, 2, 3, 6 and annually for a minimum of 36 months), but on the opposite arm from GM-CSF vaccine.
15935571|NCT03376477|Other|Placebo Prevnar13|Saline will be used for placebo. Placebo prevnar will be administered at the same time points as the GM-CSF vaccine or Placebo GM-CSF Vaccine (day 14 of cycles 1, 2, 3, 6 and annually for a minimum of 36 months), but on the opposite arm from GM-CSF vaccine or placebo GM-CSF vaccine.
15935572|NCT03376477|Other|Placebo GM-CSF Vaccine|Saline will be used for placebo. Each placebo vaccine will consist of three total intra-dermal injections on day 14 of cycles 1, 2, 3, 6 and annually for a minimum of 36 months in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). In the event that the specified limb is contraindicated, the dominant arm may be used. Placebo injection sites shall be at least 5 cm at needle entry from the nearest neighbor. The approximate volume of each injection is approximately 0.7-0.8ml.
15935573|NCT03376464|Device|Xeomin Cosmetic|Xeomin Cosmetic is the purest commercially available botulinum toxin type A available to date. It has been approved by Health Canada since 2012 for the temporary improvement in the appearance of moderate to severe glabellar lines.
15935574|NCT03376451|Other|Assessment of endometrium and blood biomarkers for endometriosis diagnosis|Biological samples will be collected from patients, sent to Endodiag, Paris, in France and be processed through IHC and molecular biology techniques to assess the ability of the identified biomarkers signature to diagnose and prognose endometriosis.
15935575|NCT03376438|Other|Prospective observational cohorts|Patients with AF or SVT that is significant enough to consider prenatal treatment are eligible for enrollment. Management decisions are made at each patient encounter by the primary physician based on clinical findings and may include: 1) no antiarrhythmic treatment; 2) transplacental antiarrhythmic treatment; 3) direct fetal antiarrhythmic treatment; 4) delivery. Patients enrolled in the FAST Registry will be followed from the time of enrollment until the baby is discharged after birth.
15935576|NCT03376412|Device|Raindrop Near Vision Inlay|A maximum of 60 consecutive non-dominant eyes will be implanted with the Raindrop Near Vision Inlay.
15935577|NCT03376399|Other|Gastroparesis Cardinal Symptom Index Questionnaire|Patients with an established diagnosis of Diabetic Gastroparesis that are interested in a sleeve gastrectomy for weight loss will be asked to participate in the registry. Once the consent process is complete the patient will be asked to complete the Gastroparesis Cardinal Symptom Index Questionnaire prior to weight loss surgery and 30 days, 3 months, 6 months and 12 months after surgery.
15935578|NCT03376386|Radiation|Adaptive dose-Escalated multi-modality image-guided radiotherapy|FDG-PET/CT-scan will be used twice during radiotherapy for a mild dose-escalation to the less-responding parts of the tumor. By adapting the radiotherapy plan, these areas will receive 74-78 Gy.
15935579|NCT03376373|Behavioral|neurofeedback|real-time feedback on accuracy of emotion recognition
15935580|NCT03376347|Device|FlotracIQ with HPI algorithm|FlotracIQ with hypotension probability indicator (HPI) algorithm connected to arterial line. The treating anesthetist is provided with guidance by means of a flowchart suggesting when to treat and what. Timing of treatment and choice of treatment is then left to the discretion of the attending physician.
15935581|NCT03376334|Other|Mental Motor Imagery|
15935582|NCT03376321|Drug|Pimodivir 600 mg|Participants will receive pimodivir 600 mg orally twice daily for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of pimodivir on Day 1 [evening], dosing will continue until the morning of Day 6). Participants who meet treatment extension criteria may receive an additional 5 day course of the same treatment as received at study start (on Days 6 through 10).
15935583|NCT03376321|Drug|Placebo|Participants will receive placebo matching to pimodivir, orally twice daily for 5 days (on Days 1 through 5; for participants who will receive only 1 dose of placebo on Day 1 [evening], dosing will continue until the morning of Day 6). Participants who meet treatment extension criteria may receive an additional 5 day course of the same treatment as received at study start (on Days 6 through 10).
15935584|NCT03376321|Other|SOC Treatment|Participants may receive SOC treatment as a part of background therapy. The SOC treatment is determined by the investigator based on local practice, and may include influenza antivirals and/or supportive care only. The choice to use influenza antivirals as part of the SOC should be started no later than the day when participants initially receive pimodivir. An influenza antiviral as part of the SOC cannot be changed (for example, switching one influenza antiviral for another) during either the treatment period or extension phase, with the exception that an influenza antiviral may be discontinued in the case of a suspected AE.
15935585|NCT03376308|Diagnostic Test|Pain Score|"Four poin scala 0=No Pain
~mild
~intermediate
~severe"
15935586|NCT03376308|Diagnostic Test|Withdrawal movement score|"Withdrawal movements
~no movement response
~movement limited to the wrist
~movement limited to the elbow/shoulder,
~generalized movement response."
15935587|NCT03376308|Diagnostic Test|hemodynamic response|Hemodynamic data were recorded in the patients taken in the operation room. (T0). Hemodynamic values (T1) measured 1 minute after administration of intravenous propofol were recorded. Hemodynamic values (T2) measured 1 minute after administration of intravenous rocuronium were recorded. Hemodynamic values (T3) measured 1 minute after administration of endotracheal intubation were recorded.
15935588|NCT03376295|Drug|LABA and the LAMA tiotropium (LABA-TIO)|combinational drug
15935589|NCT03376295|Drug|LABA and an ICS (LABA-ICS)|combinational drug
15935590|NCT03376282|Other|Hyperbaric Oxygen oxygen therapy (HBOT)|60 daily sessions, 5 days/week, 120 minutes each, 100% oxygen at 2ATA.
15935591|NCT03376269|Biological|HBOT|•HBOT of 2 ATA for 90 minutes O2 100%, for 60 treatments
15935696|NCT03375424|Biological|vedolizumab|duration of disease and kind of therapy
15935592|NCT03376269|Behavioral|Psychotherapy|creative art psychotherapy which includes self drawing and daily diary alongside professional psychotherapy sessions
15935593|NCT03376256|Device|Compuflo Epidural Instrument|Compuflo Epidural Instrument will be used to measure pressure levels in the thoracic epidural space while performing thoracic epidural anesthesia.
15935594|NCT03376243|Other|LIPIKAR BAUME AP+ emollient|Structured education on prevention guidelines
15935595|NCT03376230|Other|Collect of blood, urines, and intestinal biopsies|
15935596|NCT03376217|Other|IPTp delivered by HSAs|Pregnant women will have the option to receive IPTp-SP from Health surveillance assistants (HSAs). SP is recommended in Malawi for prevention of malaria during pregnancy, but currently it is only available at antenatal clinics.
15935597|NCT03376204|Other|No intervention|No intervention
15935598|NCT03376191|Drug|apatinib|Clinicians chose the initial dose of apatinib according to the patient's physical condition. Besides the clinicians adjusted the dose according to the patient's tolerance during the medication.The dosage was demanded not higher than 750 milligram (mg) per day. The patients received apatinib continuously, 28 days for a period, until intolerance, no longer getting benefits or patient wanted stop.
15935599|NCT03376178|Combination Product|lidocaine and ropivacaine injection through catheters|injection of local anesthetic through an endhole or a sixhole femoral nerve catheter in the context of total knee replacement. Analgesic properties at 24 and 48h of both groups registered.
15935600|NCT03376152|Behavioral|Electric Kettle Promotion|Provision of free electric kettles and promotional materials/information
15935601|NCT03376139|Drug|Zonisamide|Zonisamide capsules titrated to a maximum tolerated dose of 400 mg/day for 35 days +/- 4 days, followed by a 14 day down-titration period.
15935602|NCT03376139|Drug|Placebo Comparator|Encapsulated placebo filler (lactose) for 35 +/- 4 days, followed by a 14 day down-titration period. Placebo will go through a similar perceived titration process to maintain blind.
15935603|NCT03376126|Other|Minimal-invasive isolated limb perfusion|Minimal-invasive isolated limb perfusion
15935604|NCT03376113|Behavioral|the volitional help sheet|A sheet includes two columns: one shows critical situations that easily trigger self-harm; other one shows appropriate solutions for patients to prevent self-harm.
15935605|NCT03376100|Procedure|Ultrasound guided nerve blocks|Ultrasound guided nerve blocks of the radial and median nerves
15935606|NCT03376100|Procedure|Hematoma Block|Conventional local anesthetic method using hematoma block
15935607|NCT03376074|Device|Hypothermic oxygenated perfusion (HOPE)|25 patients: Application of HOPE for 2 hours, perfusion rate 100-150 ml/min, pressure controlled, perfusion pressure < 3 mm Hg, perfusion route portal vein, recirculating system, perfusion volume 2 L, perfusate solution (UWMP®), perfusate temperature 4-12 °C, perfusate oxygenation 40 KPa
15935608|NCT03376074|Other|Conventional cold storage|75 patients transplanted in Rennes between 2010 and 2015 with a cold stored grafts, matched (ratio 1: 3) using a propensity score calculated according to some parameters
15935609|NCT03376061|Drug|Tranexamic Acid|Tranexamic Acid is a medication used to treat or prevent excessive blood loss from major trauma, post partum, surgery, tooth removal, nose bleeds, and heavy menstruation.
15935610|NCT03376048|Procedure|Wound infiltration plus TAP|"TAP block: At the beginning of the main surgical procedure the surgeon will perform a TAP with ropivacaine infiltration, bilaterally in the anterior axillary line, between the costal margin and iliac crest in the intermuscular plane between the internal oblique and transversus abdominis muscles, the anesthesiologist under ultrasound guidance, the surgeon under laparoscopic guidance (two pops technique).
~Wound infiltration : Wound infiltration of ropivacaine will be performed by the surgeon before skin incision."
15935611|NCT03376048|Procedure|Wound infiltration|Wound infiltration of ropivacaine will be performed by the surgeon before skin incision.
15935612|NCT03376035|Other|Temperature measurement of breast|Multiple measurements will be obtained from the ear, chest, breast, abdomen, and hands.
15935613|NCT03376022|Other|Attitudes, knowledge|To investigate attitudes and knowledge to oral Health and oral care
15935614|NCT03376009|Diagnostic Test|Blood sample for serum and plasma biomarkers:|Serum/plasma biomarkers: Approximately 10ml (3 teaspoons) of blood will be extracted to measure pre-specified biomarkers of renal injury including kidney injury molecule-1 (KIM-1), cystatin C and neutrophil gelatinase-associated lipocalin (NGAL). Samples will then be stored to facilitate measurement of additional biomarkers in the future.
15935615|NCT03376009|Diagnostic Test|Urine sample for biomarkers|Urinary biomarkers: A random urine sample will be obtained to measure urinary protein to creatinine ratio (uPCR), KIM-1 and liver-type fatty acid binding protein (L-FABP)
15935616|NCT03376009|Diagnostic Test|Cardiac bio-impedance (Cardioscreen Medis)|Cardiac bio-impedance - a non-invasive assessment of cardiac output, cardiac index and systemic vascular resistance index using the bio-impedence technique (Cardioscreen 1000 Medis) Cardiac bio-impedance is performed by attaching sticky electrodes to the participant's neck and thorax. These electrodes pass a very low, constant and alternating current (1.5 mA, 86 kHz) across the thorax, which is imperceptible to the patient. This provides beat by beat data on cardiac output and haemodynamic measurements.
15935617|NCT03376009|Diagnostic Test|Aortic pulse wave velocity (APWV) (TensioMed and SphygmoCor)|"Aortic pulse wave velocity (APWV) a non-invasive measure of arterial function using oscillometric recordings to detail peripheral and central haemodynamics. This will be measured using two different techniques:
~TensioMed Arteriograph: After a rest period a blood pressure cuff inflates and deflates twice on the arm. This takes ~3 minutes and should cause only mild, temporary discomfort. The test will routinely be performed in duplicate to ensure accuracy of results.
~SphygmoCor: A pressure sensor is held over the radial pulse at the wrist to analyse the pulse wave. Then held over the carotid artery and/or femoral artery to assess the speed of the pulse wave through the body. The probe is similar to an ultrasound probe and should not cause any discomfort."
15935618|NCT03376009|Diagnostic Test|Optical Coherence Tomography (Spectralis OCT)|"OCT is a non-invasive imaging test which uses light waves to take cross sectional images of the back of the eye. Examination of the retinal and retinal nerve fibre layer thickness, macular volume, and choroidal thickness provides an assessment of generalised systemic microvascular injury. A strong correlation between choroidal thickness and renal dysfunction has previously been shown in patients with chronic kidney disease (Balmforth C et al, JCI Insight 2016).
~The participant is asked to sit in front of the OCT machine and rest their chin on a support to keep it motionless. The equipment will then scan the eye without touching it. Scanning takes about 5 - 10 minutes."
15935619|NCT03376009|Diagnostic Test|Arterial Spin Labelling Magnetic Resonance Imaging|"Magnetic resonance imaging using arterial spin labelling (ASL-MRI) This promising quantitative technique has the potential to identify dysregulated renal perfusion, stratify risk of AKI in pre-OLT patients, and to monitor alterations in renal haemodynamics in the post transplantation setting.
~We aim to recruit 5 participants with 'normal' renal function (eGFR≥60ml/min/1.73m2) and a further 5 participants with 'abnormal' renal function (eGFR<60ml/min/1.73m2)
~ASL-MRI will be performed in this subgroup during the week of OLT assessment and then repeated at 6-weeks post transplantation in those participants who undergo OLT during the study period."
15935620|NCT03375996|Drug|cyclopentolate 0.5% eye drops|cyclopentolate 0.5% eye drops and measurement of the pupillary mydriasis (dilatation)
15935621|NCT03375983|Biological|Blood-stage infection of P.vivax|The P. vivax infected blood will be confirmed to follow the national standard of blood donation to ensure that only P. vivax is included, excluding the presence of P. falciparum. Exclude other infectious diseases according to the test of national standard of blood donation.
15935622|NCT03375970|Other|TCM|oral chinese herb, chinese topical ointment
15935623|NCT03375970|Other|Western medicine|oral steroid, oral antihistamine, topical steroid
15935624|NCT03375957|Drug|ATx201|two hundred microliters (200 μL) of test article applied to the test site areas of the upper outer arms
15935625|NCT03375957|Drug|ATx201 Placebo Gel|two hundred microliters (200 μL) of placebo applied to the test site areas of the upper outer arms
15935626|NCT03375944|Other|Rehabilitation|"The purpose of this work package is to evaluate short- and long-term clinical effects of optimal, continuous and regularly controlled tele-rehabilitation, which is based on exercise training, intensive dietary and educational program focused on lifestyle and risk factors modification. The main expectations of OCR is to normalize annual mortality to the level of the low risk healthy population."
15935627|NCT03375931|Behavioral|Prayer|If the patient wishes to pray, the anesthesiologist will pray for one minute before anesthesia.
15935628|NCT03375931|Behavioral|non-prayer|If the patient does not want to pray, the anesthesiologist does anesthesia without praying.
15935629|NCT03375918|Other|CONSULT-BP Educational Intervention|"The CONSULT-BP intervention includes two, 180-minute, in-persons sessions 5 weeks apart. Each session has 3 parts: 1. Pre-Clinical Practice Simulation Learning; 2. Trainee Self-Assessments of implicit bias; and 3. In-Person Clinical Practice Simulations to practice communication skills, trigger reflection, and frame group-based reflections on bias."
15935630|NCT03375905|Device|cNEP|subjects with OSA will be treated with the cNEP device with the goal of reducing the number of apneas and hypopneas
15935631|NCT03375892|Other|Deep Inspiration Breath Hold during Radiation|The DIBH technique involves the patient breathing to a specified threshold and then holding that level of inspiration during every radiation therapy field delivered.
15935632|NCT03375892|Other|Free breathing during radiation|The patient will be instructed to breathe freely.
15935633|NCT03375879|Device|Bandage contact lens|Bandage contact lens
15935634|NCT03375866|Other|Pretzels|Subjects consume 240 kcal of pretzels daily for 8 weeks.
15935635|NCT03375866|Other|Mixed nuts|Subjects consume 240 kcal of mixed nuts daily for 8 weeks.
15935636|NCT03375853|Behavioral|Computer Based Response Training Weight Loss Intervention|Participants complete four computer based training tasks each visit, over the course of a few lab visits. Participants then perform weekly booster sessions in a more natural home or community environment over the internet using the same computer based training tasks.
15935637|NCT03375853|Behavioral|Generic Response Training Control Intervention|Participants complete four computer based training tasks each visit, over the course of a few lab visits. Participants then perform weekly booster sessions in a more natural home or community environment over the internet using the same computer based training tasks.
15935638|NCT03375840|Behavioral|Text-only PWL|Control condition
15935639|NCT03375840|Behavioral|Low-emot PWL|Pictorial warning
15935640|NCT03375840|Behavioral|High-emot PWL|Pictorial warning
15935641|NCT03375840|Behavioral|Immediate posttest|
15935642|NCT03375840|Behavioral|delay posttest|
15935643|NCT03375827|Other|IGCDG|The IGCDG reviews topics of concern for patients with metastatic breast cancer.
15935644|NCT03375814|Drug|Crocin|This group (osteoarthritic patients) can receive crocin with conventional therapy
15935645|NCT03375814|Drug|Placebo Oral Tablet|The group that takes Placebo Oral Tablet. They received the conventional treatment and Placebo Pills..
15935646|NCT03375801|Other|Decision Aid|This will be an online tool giving evidence based information and explanation on their options.
15935647|NCT03375788|Drug|Tesamorelin|Tesamorelin F4 formulation 1.4mg daily
15935648|NCT03375788|Drug|Identical Placebo|Placebo injection daily
15935649|NCT03375775|Drug|Subcutaneous immunotherapy with ALK Alutard birch or ALK Alutard timothy|According to standardized clinical protocol
15935650|NCT03375775|Other|No immunotherapy, symptomatic treatment|These patients will only receive symptomatic treatment for their allergic rhinoconjunctivitis.
15935651|NCT03375762|Other|Remote ischemic perconditioning|Five 5-minute inflations/deflations of an automatic device placed on the upper non-paretic arm initiated in the ambulance on the way to hospital in the case of stroke code activation and RACE score >0 and RACE motor item>0
15935652|NCT03375762|Other|Sham remote perconditioning|Sham five 5-minute inflations/deflations of an automatic device placed on the upper non-paretic arm initiated in the ambulance on the way to hospital in the case of stroke code activation and RACE score >0 and RACE motor item>0
15935653|NCT03375749|Behavioral|Standing desk intervention|Standing desk converter
15935654|NCT03375749|Behavioral|Waitlist control|Control
15935655|NCT03375736|Device|whole body vibration|The children and young adults will receive the WBVT when standing still on a vibration platform of 20 Hertz and a peak-to-peak amplitude of 2 mm: sessions will be 18 minutes in length, 4 days per week for 4 weeks. Assessments will be performed at baseline and at completion of the intervention to examine the functional abilities of these children and young adults. The vibration frequency, duration and amplitude will be progressively increased over 2 weeks to the maximum of 3 minutes of 20 Hz with a peak-to-peak amplitude of 2mm.
15935695|NCT03375437|Genetic|Blood and tumor samples|"FFPE tumor block (archival or a dedicated freshly collected tumor biopsy) will be collected for all enrolled patients and centralized.
~Blood sampling for Translational Research (optional) (2*10mL EDTA)"
15935656|NCT03375723|Other|Information on anatomy and physiology, and breathing technique|The patients in the treatment group receive information about what acute PE is regarding anatomy and physiology, a review of what causes the respiratory associated pain in acute PE and also a review of the breathing technique to manage their respiratory associated pain. The given information is standardized and the patient also receives written information with both text and pictures. Patients in the treatment group will meet the physiotherapist at day 1, 2 and the patients also has an opportunity to see the physiotherapist or talk to her at the phone if there are any questions concerning the study.
15935657|NCT03375723|Other|Usual care treatment|Usual care treatment given to patients with respiratory associated pain in acute PE, which is treatment with analgesics. The information on anatomy and physiology in acute PE is the usual information given by the physician at the ward that the patient is treated.
15935658|NCT03375710|Device|Cordella™ Heart Failure System|"The Cordella™ Heart Failure System collects, records, and transmits physiologic data and communications from the patient at home to clinicians for assessment, patient communication, and patient-centered heart failure management. The system consists of the following components:
~myCordella™ Patient Management Portal
~myCordella™ Hub
~myCordella™ Peripherals, including the Cordella™ Pulmonary Artery Sensor System (CorPASS)"
15935659|NCT03375697|Drug|JNJ-63733657|Subjects will receive single (Part 1) or multiple (Part 2) ascending dose levels of JNJ-63733657 intravenously.
15935660|NCT03375697|Drug|Placebo|Subjects will receive matching placebo intravenously.
15935661|NCT03375684|Other|Conventional chest physiotherapy|Programme will include diaphragmatic breathing exercise, thoracic expansion exercises, incentive spirometer exercise (Triflo), oscillatory PEP (Flutter), postural drainage and coughing tecniques.
15935662|NCT03375684|Other|Inspiratory muscle training|Threshold IMT device will be used for the training. Training intensity will set at 30% of the maximum inspiratory pressure.
15935663|NCT03375671|Drug|Ketalar|single administration of 5 mg/kg, IM
15935664|NCT03375671|Drug|Midazolam injection|single administration of 5 mg, IM
15935665|NCT03375671|Drug|Haloperidol|single administration of 5 mg, IM
15935666|NCT03375658|Other|PDWS Intervension|Patients admitted to the emergency department in the intervention period will have their vital values presented on the PDWS in addition to existing patient monitoring systems
15935667|NCT03375645|Drug|Any oral opioid|Emergency department patients who receive a prescription for an oral opioid
15935668|NCT03375632|Drug|FYU-981|Oral daily dosing for 14 weeks
15935669|NCT03375619|Other|Long-Term Follow-Up of Participants who Received CAR-20/19-T cells|No study drug is administered in this study. Participants who received CAR-20/19-T cells in a previous trial will be evaluated in this trial for long-term safety and efficacy.
15935670|NCT03375606|Biological|CSL730|Solution for IV infusion
15935671|NCT03375606|Other|Placebo|Saline solution for IV infusion
15935672|NCT03375593|Drug|Hydrocodone 5Mg/Acetaminophen 500Mg Tab|tablet
15935673|NCT03375593|Drug|Acetaminophen 500Mg Tab|tablet
15935674|NCT03375593|Drug|Ibuprofen 600 mg tab|tablet
15935675|NCT03375580|Dietary Supplement|TLC|transform life custom (TLC)
15935676|NCT03375580|Drug|metformin|0.5g metformin group，PO tid
15935677|NCT03375580|Drug|Compound Zhenzhu Tiaozhi capsule|Compound Zhenzhu Tiaozhi capsules consist of eight Chinese herbal medications, such as Ligustrum lucidum, Atractylodes macrocephala, Radix Salviae Miltiorrhizae, pseudo-ginseng, Astragalus membranaceus.
15935678|NCT03375580|Drug|Simvastatin|20mg simvastatin, PO qn
15935679|NCT03375567|Procedure|Guided Lesion Biopsies|After patients are treated with Carfilzomib Lenalidomide Dexamethasone (CRD), lesion biopsies will be performed per usual care. Patients will have biopsies performed on lesions using a novel image guided technique.
15935680|NCT03375567|Procedure|Standard Lesion Biopsies|After patients are treated with Carfilzomib Lenalidomide Dexamethasone (CRD), lesion biopsies will be performed per usual care. Patients will have biopsies performed on lesions using a novel image guided technique.
15935681|NCT03375541|Other|Risk Aversion Calculator|The calculator asks the participant to rate their level of aversion to having a set list of potential medication side effects (0 = no concern; 1 = mild concern; 2 = moderate concern; 3 = moderate to severe concern; 4 = severe concern)
15935682|NCT03375528|Device|DES implantation|Coronary artery intervention using Drug eluting stent and Intravascular Ultrasound is performed.
15935683|NCT03375515|Drug|Hydromorphone|"For opioid-intolerant patients: continuous infusion of hydromorphone 0 mg per hour, and a demand dose of 0.5 mg with a lockout interval of 15 minutes.
~For opioid-tolerant patients: basal rate 0 mg per hour, and a demand dose of 10% of the hydromorphone dose equivalent to the total opioid taken in the previous 24 hrs with a lockout interval of 15 minutes."
15935684|NCT03375515|Device|PCA pump|"For opioid-intolerant patients: initial dose 0.5 mg intravenous hydromorphone.
~For opioid-tolerant patients: intravenous hydromorphone with a initial dose equivalent to 10%(5-15%) of the total opioid taken in the previous 24 hrs."
15935685|NCT03375502|Drug|Varicella Vaccine|The subject will receive investigational product or comparator.
15935686|NCT03375489|Other|Telehealth|"Teleconference meeting with the palliative care team. Palliative care is a medical specialty focused on lessening (or palliating) patients' symptoms and helping patients and their families cope with a serious illness"
15935687|NCT03375489|Other|In-person PC|"In person meeting with the palliative care team. Palliative care is a medical specialty focused on lessening (or palliating) patients' symptoms and helping patients and their families cope with a serious illness"
15935688|NCT03375476|Diagnostic Test|collection of cardiovascular risk scores and intraoperative cardiovascular parameters|collection of preoperative cardiovascular risk scores and intraoperative cardiovascular parameters
15935689|NCT03375476|Diagnostic Test|cardiac troponin assay|plasmatic concentration of high sensitive cardiac troponin will be measured at baseline and on postoperative day 1, 2 and 3
15935690|NCT03375476|Diagnostic Test|Electrocardiogram|12 derivations ECG will be made at baseline and on postoperative day 1, 2, and 3
15935691|NCT03375463|Drug|Tirzepatide|Administered SC
15935692|NCT03375463|Drug|Tirzepatide|Administered IV
15935693|NCT03375463|Drug|Placebo|Administered SC
15935694|NCT03375450|Other|Standard of Care|Participants will be followed as per local routine primary healthcare practice
15971621|NCT03100084|Other|Blood sampling|Maternal blood sampling
15935697|NCT03375411|Device|Stent INC1|Coronary intervention with conventional angioplasty technique but with a novel bare metal stent.
15935698|NCT03375398|Dietary Supplement|Rice|Test food #1: White Rice <63.0 g (dry) Jasmine rice consumed together with 250 mL water
15935699|NCT03375398|Dietary Supplement|Sugardown™|Test food #2: White Rice < 63.0 g (dry) Jasmine rice + 3 Sugardown™ tablets consumed together with 250 mL water Test food #3: White Rice < 63.0 g (dry) Jasmine rice + 6 Sugardown™ tablets consumed together with 250 mL water
15935700|NCT03375385|Drug|dexmedetomidine/ propofol|The loading and infusion doses of dexmedetomidine hydrochloride and 1% propofol were calculated according to the patient's body weight and diluted to a 10 ml volume (labeled as loading-1 and loading-2) and a 50 ml volume (labeled as infusion-1 and infusion-2).
15935701|NCT03375372|Procedure|Scaling and Root Planing (S&RP)|dental Scaling and Root Planing and oral hygiene regimen
15935702|NCT03375359|Diagnostic Test|cfDNA screening|cfDNA screening test for aneuploidy risk assessment
15935703|NCT03375346|Device|Whole body vibration|whole body vibration exercise is a stimulus that uses vibrations generated on a machine with oscillatory movement determined by the amplitude and frequency of the vibration.
15935704|NCT03375346|Other|Exercise|maintain a half-squat position (knee joint angle at 160 degrees) on the tilt table with an incline of 60 degrees
15935711|NCT03375294|Drug|Nitrous Oxide|One hour inhalation of 50% nitrous oxide, an odorless, colorless gas FDA approved as an induction agent for dental sedation
15935712|NCT03375281|Procedure|RFA|thermal ablation using radiofrequency for HCC
15935713|NCT03375255|Drug|SRP-5051|Single dose of SRP-5051 administered as an intravenous (IV) infusion.
15935714|NCT03375242|Drug|crizotinib|"XALKORI® Capsule 200 mg／XALKORI® Capsule 250 mg Frequency and duration are according to Package Insert as follows.  The recommended dose schedule of crizotinib is 250 mg taken orally twice daily. Dosing interruption and/or dose reduction may be required based on patients' clinical status. "
15935715|NCT03375229|Other|Dry Needling|"It will be used acupuncture needles, individually packaged and sterilized, with 0.25 mm of thickness and 0.40 mm of length. The therapist will perform the grip in upper trapezius on the site of one of the two previously marked locations, according to the subject group allocation, and will insert the needle in the skin with help of a guide tube and will deepen the needle approximately 10 to 15 mm inside the trigger point. The needle will be moved up and down as in the fast-in and fast-out technique described by Hong and the movement will be repeated during 30 seconds in a cadence of approximately 1 Hz. The protocol will be the same for the groups that will receive the application directly on the trigger point and for the group that will receive the application away from the trigger point"
15935716|NCT03375229|Device|Low-Level Laser Therapy|The laser protocol used the PainAway Laser™ cluster equipment composed of one pulsed infrared laser of 905 nm, four red LEDs of 640 nm, and four infrared LEDs of 875 nm, with full device aperture of 4 cm2, total delivered energy of 39,8 J, a magnetic field of 35 Mt and treatment time of 300 seconds. The equipment was turned on only for the DNP group and it remained in slight contact with the skin during 300 s for all groups.
15935717|NCT03375216|Behavioral|sensory testing (Heat, cold, and pressure)|sensory threshold measurement is the point at which the participant feels pain due to either heat, cold, or pressure
15935718|NCT03375216|Behavioral|Promis Survey|PROMIS computer adaptive survey in anxiety, depression, pain behavior, fatigue, pian interference, physical function, sleep disturbance, self efficacy
15935719|NCT03375203|Drug|Placebo|Matching placebo will be administered once daily based upon dosing group.
15935720|NCT03375203|Drug|JNJ-42847922, 5 mg|JNJ-42847922 will be administered as 5 mg (2*2.5 mg capsule) oral capsules once daily.
15935721|NCT03375203|Drug|JNJ-42847922, 10 mg|JNJ-42847922 will be administered as 10 mg oral capsule once daily.
15935722|NCT03375203|Drug|JNJ-42847922, 20 mg|JNJ-42847922 will be administered as 20 mg oral capsule once daily.
15935723|NCT03375203|Drug|Zolpidem|Zolpidem will be administered as 5 mg or 10 mg (2*5mg capsule) oral capsule once daily based upon the local labeling information.
15935724|NCT03375190|Other|Dressing|Transparent film dressing (TegadermTM CHG Chlorhexidine Gluconate IV Securement Dressing, 3M Health Care, St. Paul, MN, USA) alone
15935725|NCT03375190|Other|Dressing + adhesive|Transparent film dressing + topical skin adhesive (SwiftSetTM Topical Skin Adhesive, CovidienTM Devon, UK) at insertion site
15935726|NCT03375190|Other|Experimental: Dressing + adhesive + strips (parallel)|Transparent film dressing + topical skin adhesive + reinforced skin closure strips (Steri-StripTM, 3M Health Care, St. Paul, MN, USA) placed parallel to long axis of catheter
15935727|NCT03375190|Other|Experimental: Dressing + adhesive + strips (perpend)|Transparent film dressing + topical skin adhesive + reinforced skin closure strips (Steri-StripTM, 3M Health Care, St. Paul, MN, USA) placed perpendicular to long axis of catheter
15935728|NCT03375190|Other|Experimental: Dressing + adhesive + strips + benzoin|Transparent film dressing + topical skin adhesive + skin closure strips + topical benzoin (Compound Tincture of Benzoin USP 10%, Professional Disposables International, Inc., Orangeburg, NY, USA) spread in a 12 centimeter by 14 centimeter area around the insertion site
15935729|NCT03375190|Other|Experimental: Dressing + adhesive + strips + spray|Transparent film dressing + topical skin adhesive + skin closure strips + medical adhesive spray (AdaptTM Medical Adhesive, Hollister Incorporated, Libertyville, IL, USA) in a 12 centimeter by 14 centimeter area around the insertion site
15935730|NCT03375177|Other|Natural history of disease|registry plan
15935731|NCT03375164|Genetic|SRP-9001|Single IV infusion of SRP-9001.
15935732|NCT03375151|Device|EEG based feedback|Participants will participate in cognitive training sessions. The therapist will use feedback from the EEG analyzed data to direct the cognitive therapy based on the therapist's guidance to maximize the intensity and duration of the patient's high brain engagement Index (BEI) during exercise.
15935769|NCT03374904|Behavioral|Control Group|Play therapy will be administered once a week plus inpatient treatment as usual for 4 weeks
15935984|NCT03373188|Biological|Anti-SEMA4D Monoclonal Antibody VX15/2503|Given IV
15935733|NCT03375151|Behavioral|Standard practice based feedback|Participants will participate in cognitive training sessions. The therapist will give feedback to the participants during the exercise based on their performance only according to the his therapist standard practice.
15935734|NCT03375151|Behavioral|No feedback|Participants will participate in cognitive training sessions. The therapist will not guide them during the sessions.
15935735|NCT03375138|Drug|belatacept|Specified dose on specified days
15935736|NCT03375125|Dietary Supplement|Probiotic|L. reuteri DSM 17938 & L. reuteri ATCC PTA 5289 ) will be given at a dose of 2x10^8 Colony Forming Units (CFU). One lozenges is to be taken twice per day (one in the morning and one in the afternoon) giving a total daily dose of at least 4x108 CFU/day.
15935737|NCT03375125|Other|Placebo|Placebo will have identical appearance, taste, and flavor, except for lacking the bacteria. One lozenges will be taken twice per day (one in the morning and one in the afternoon)
15935738|NCT03375112|Procedure|Fascia iliaca compartment block|The patient will be brought to the block room within 30 minutes of arriving in recovery. An injection of local anesthetic into the fascia iliaca compartment using ultrasound guidance will be administered. The patient will then be transported back to recovery.
15935739|NCT03375112|Drug|Placebo|The patient will be brought to the block room within 30 minutes of arriving in recovery. An ultrasound probe will be placed to the skin and a blunt needle will be touched to the patient's skin in the area that a fascia iliaca compartment block would be performed. The patient will then be transported back to recovery.
15935740|NCT03375112|Drug|Bupivacaine|A one time dose of 40 milliliters of 0.5% bupivacaine will be injected into the fascia iliaca compartment
15935741|NCT03375099|Behavioral|Lethal Means Counseling|Single session motivational interviewing based interaction aimed to increase the safe storage of firearms in an effort to reduce suicide risk.
15935742|NCT03375099|Behavioral|Health and Stress Reduction|Single session motivational interviewing based interaction aimed to reduce vulnerability to negative outcomes across four domains: sleep, diet, exercise, and stress.
15935743|NCT03375086|Drug|APX3330|APX3330 will be supplied as 60 and 120 mg orally administered tablets. Patients will receive a fixed dose of APX3330 twice daily (i.e., bid) each day of a 21-day cycle. The starting dose of APX3330 will be a daily dose of 240 mg (i.e., 120 mg/dose bid). Doses will be increased until identification of a maximum tolerated dose or bio-effective dose, whichever is lower.
15935744|NCT03375073|Other|Positive communication during medical transmission|Use of positive communication for medical transmission to the anaesthetic team who takes over the patient.
15935745|NCT03375047|Drug|MRT5005|Nebulization of MRT5005
15935746|NCT03375047|Drug|Normal saline|Normal Saline for Inhalation
15935747|NCT03375034|Drug|NDMC 20mg|Oral administration of one NDMC 20mg capsule and two Placebo capsules
15935748|NCT03375034|Drug|NDMC60mg|Oral administration of three NDMC 20mg capsules
15935749|NCT03375034|Drug|Clonazepam 1.5mg|Oral administration of three clonazepam 0.5mg capsules
15935750|NCT03375034|Drug|Placebo|Oral administration of three Placebo capsules
15935751|NCT03375021|Drug|CX717 200 mg|CX717 200 mg capsules BID
15935752|NCT03375021|Drug|CX717 800 mg|CX717 4 X 200 mg capsules BID
15935753|NCT03375021|Drug|Placebo|Placebo 200 mg or 800 mg capsules BID
15935754|NCT03375008|Diagnostic Test|Imaging diagnostic and biopsy|Liver biopsy and MRI scan
15935755|NCT03374995|Other|Best Practice|Receive standard of care
15935756|NCT03374995|Other|Quality-of-Life Assessment|Ancillary studies
15935757|NCT03374995|Device|Topical Keratin|Given topically
15935758|NCT03374982|Device|DentalVibe|The DentalVibe is a handheld device that delivers vibration to the tissue during local anesthetic administration.
15935759|NCT03374969|Behavioral|Attachment and Biobehavioral Catch-Up|Attachment and Biobehavioral Catch-up (ABC) is a 10-session, weekly intervention delivered in the family's home. ABC addresses three primary issues. First, young children who have experienced early adversity are especially in need of nurturance and parents who behave in synchronous ways and delight in them. Next, when parents behave in frightening ways, it is difficult for children to look to them for reassurance when distressed. This can be particularly difficult for children who have experienced early adversity. Therefore, this intervention helps parents learn how to: 1) behave in nurturing ways when children are distressed; 2) behave in synchronous, delighted ways when children are not distressed; and 3) avoid behaving in frightening or intrusive ways. Interventionists are provided with a manualized protocol, but tailor specific session content to each family's needs. Sessions are videotaped, both for playback to families, and for supervision.
15935760|NCT03374969|Behavioral|Developmental Education for Families|Developmental Education for Families (DEF) is a 10-session, weekly intervention delivered in the family's home. DEF focuses on enhancing gross and fine motor skills, cognition and language development. The age-based protocols (i.e., 6-24 months,) provide information about the developmental themes of focus for each week and suggest activities to enhance the target skills for that week. However, the protocols do not provide a direct script with which to conduct the sessions. Interventionists tailor the developmental program session to the needs of the child and family by considering the child's current gross, fine, cognitive and language skills and creatively preparing several activities that will address the session topics.
15935761|NCT03374956|Drug|Phentermine-Topiramate|Extended Release at dose of 7.5/46 mg oral daily
15935762|NCT03374956|Drug|Liraglutide|dose of 3 mg subcutaneous daily
15935763|NCT03374956|Drug|Naltrexone/bupropion|Oral naltrexone extended-release/bupropion extended-release at dose of 32/360 mg oral daily (divided in 2 tables in morning and 2 tablets in evening)
15935764|NCT03374956|Drug|Phentermine|15-37.5 mg oral daily
15935765|NCT03374943|Drug|KB004|KB004 is a recombinant, non-fucosylated, IgG1κ (human f-allotype) monoclonal antibody targeting the extracellular ligand binding domain of the EphA3 (ephrin receptor) tyrosine kinase
15935766|NCT03374930|Procedure|Multiple rapid swallows test|Multiple rapid swallows test consists in giving to patient 4 to 6 sips of 2 mL of water, with an interval less than 4 seconds between the different sips.
15935767|NCT03374917|Drug|ABBV-951|powder for solution
15935768|NCT03374904|Behavioral|Video Feedback|first, a play interaction between the child and caregiver is recorded (5 to 10 minutes), then the therapist and caregivers watch together a selected part of the video (1 to 2 minutes) and provide feedback with a six step protocol.
15935806|NCT03374579|Diagnostic Test|Fluid challenge|Fluid challenge and measure change in co2 gap
15935770|NCT03374891|Other|Educational video and/or handout|The intervention includes a video and/or handout (whichever is easier for the participant) that will give information about defibrillators and about other patients' experiences with their decisions about defibrillators.
15935771|NCT03374878|Other|no oral contraceptive and training|10 weeks of training in a group of oral contraceptive users
15935772|NCT03374878|Other|oral contraceptive and training|10 weeks of training in a group of users of oral contraceptives
15935773|NCT03374865|Other|Facetalk|Area of interest: communication during Facetalk consultations
15935774|NCT03374865|Other|Face-to-face consultation|Area of interest: communication during face-to-face consultations
15935775|NCT03374852|Drug|CPI-613|500 mg/m2, IV infusion at a rate of 4 mL/min via a central venous port
15935776|NCT03374852|Drug|mFOLFIRNOX|mFOLFIRNOX (given immediately after CPI-613 administration):
15935777|NCT03374839|Drug|TIL + IL-2 + Nivolumab|"The patients will receive Nivolumab (at a dose of 3 mg per kilogram of body weight) every 2 weeks from day0 until week52.
~Two TIL (Tumor Infiltrating Lymphocytes) injections will be performed: at week 14 and at week 18.
~The TIL injections are systematically followed by subcutaneous injections of Proleukin® (IL-2) at a concentration of 6 million international unit (IU) per day for 5 days."
15935778|NCT03374826|Diagnostic Test|Dedicated axillary hybrid PET-MRI|All clinically node negative patients will undergo a hybrid PET-MRI axilla preoperatively, followed by breast surgery and SLNB.
15935779|NCT03374813|Device|MimetikOss (bone grafting surgery)|Ridge preservation bone grafting after dental extraction.
15935780|NCT03374813|Device|Bio-Oss (bone grafting surgery)|Ridge preservation bone grafting after dental extraction.
15935781|NCT03374800|Drug|Placebo (0.9% saline)|normal saline
15935782|NCT03374800|Drug|Pantoprazole|40 mg powder for injection reconstituted with 0.9% saline
15935783|NCT03374787|Device|Fusion Sound Processor|Sound Processor
15935784|NCT03374774|Drug|BIAsp 30|Participants will receive commercially available BIAsp 30 according to routine clinical practice. The physician will determine the starting dose and any potential later change to the dose.
15935785|NCT03374761|Other|Families First Home Visiting Program|10 group sessions and 4 home visits with community facilitators emphasizing positive parenting
15935786|NCT03374748|Other|N/A - observational study|N/A - observational study
15935787|NCT03374735|Device|SETALUM™ Sealant|SETALUM™ Sealant to be applied on the suture line
15935788|NCT03374722|Drug|Opioids|Mechanically ventilated critically ill patients who receive continuous opioid infusion for more than 24 hours will be observed for withdrawal symptoms when rate of opioid infusion is disrupted or decreased
15935789|NCT03374709|Drug|Oxtellar XR 150Mg Extended Release Tablet|Oxtellar XR
15935790|NCT03374696|Behavioral|SAFETY|
15935791|NCT03374696|Behavioral|Standard education|
15935792|NCT03374683|Behavioral|RR Digital Tool|"Participants proceed through three chapters in the tool: https://outsideplay.ca.
~Chapter 1: most important attributes they want for their child; their child's favourite play activities; their own childhood play activities; how their child's and their own play activities compare.
~Chapter 2: imagining themselves in three video segments where they must decide whether they allow their child to climb a tree, walk home from school, and use box cutters to build a fort. They reflect on their barriers and things that helped them let go.
~Chapter 3: revisiting the most important attributes they want for their child and whether there is anything they want to change, setting a realistic goal, outlining steps for attaining that goal, and setting start date."
15935793|NCT03374683|Behavioral|RR In-Person Workshop|Participants engage in a facilitator guided discussion of the same tasks as the RR digital tool. Participants are taken through each task using PowerPoint slides that include the videos from the digital tool. The facilitator guide contains detailed guidance on discussion for each component and length of time to be dedicated to each slide. Participants are provided with a paper booklet to complete that mimics the online tasks.
15935794|NCT03374683|Behavioral|Position Statement on Active Outdoor Play|"The position statement summarizes the issues and research regarding children's access to outdoor play and provides recommendations for various stakeholders. It states that access to active play in nature and outdoors - with its risks - is essential for healthy child development and recommends increasing children's opportunities for self-directed play in all settings. The Position Statement includes recommendations for parents, educators, health professionals, administrators and various level of governments to address the barriers to children's outdoor play. It addresses common misconceptions and encourages that danger be differentiated from risk and outdoor play and fun be valued as much as safety (ParticipACTION Canada, 2015; Tremblay et al., 2015)."
15935795|NCT03374670|Drug|Zimura|Zimura in combination with Eylea
15935796|NCT03374670|Drug|Eylea|Zimura in combination with Eylea
15935797|NCT03374657|Biological|CPK850|In one of 5 dose levels administered via subretinal injection under anesthesia
15935798|NCT03374644|Device|SentriTM ETCO2 adult nasal cannula|Sentri nasal cannula is the device which designed to sample exhaled ETCO2 in non-intubated patients during the administration of supplementary oxygen. By delivering oxygen through one prong and sampling exhaled gas from the other prong, the nasal cannula can provide end tidal values comparable to those achieved with intubated patients. It is fitted to the patients as same manner as conventional nasal cannula. Furthermore, it consists of curved prong to improve the anatomical fit.
15935799|NCT03374631|Device|active anodal tDCS|active anodal tDCS with behavioral tasks and self-report measures to assess paranoid ideation
15935800|NCT03374631|Device|sham tDCS|sham tDCS with behavioral tasks and self-report measures to assess paranoid ideation
15935801|NCT03374618|Other|Blood sample|Blood sample to quantify and qualify netosis in vivo and ex vivo after different stimulations in SSC, SLA and healthy controls
15935802|NCT03374605|Device|active tDCS|15 minutes of active (2mA) high definition tDCS will be applied to the participant's skull. The anodal electrode will be placed over 10-20 EEG coordinate AF7 and cathodal electrode over coordinate Fz.
15935803|NCT03374605|Device|sham tDCS|15 minutes of sham high definition tDCS will be applied to the participant's skull. The anodal electrode will be placed over 10-20 EEG coordinate AF7 and cathodal electrode over coordinate Fz.
15935804|NCT03374592|Radiation|Volumetric Intensity-Modulated Arc Therapy|Advanced radiotherapy technique
15935805|NCT03374592|Radiation|Conventional Radiotherapy|Conventional radiotherapy technique
15935985|NCT03373188|Biological|Ipilimumab|Given IV
15935807|NCT03374553|Device|MINIject 636 implant|"MINIject 636 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant CS636 and a Delivery Tool.
~The Delivery Tool is a single-use tool, designed for inserting the CS636 implant into the sub-scleral location through an ab-interno minimally-invasive approach."
15935808|NCT03374540|Drug|Rivaroxaban (Xarelto, BAY59-7939)|15/20 mg
15935809|NCT03374540|Drug|Vitamin K antagonist (VKA)|Individually adjusted dose
15935810|NCT03374527|Other|blood sample collection|Blood samples are collected from patients with psoriasis vulgaris and patients with psoriatic arthritis following the routine procedure. Blood samples will also be collected from healthy control subjects.
15935811|NCT03374527|Procedure|Synovial Fluid collection|Synovial fluid is collected when prescribed in patients with psoriatic arthritis
15935812|NCT03374514|Drug|Dexamethasone|instilation of the solution in the middle ear
15935813|NCT03374514|Drug|Sterile isotonic saline solution|Sterile isotonic saline solution
15935814|NCT03374501|Dietary Supplement|Sugardown™|Test food #2: 495.0 g Sprite™ soft drink plus 2 Sugardown™ tablet consumed with 250 mL water (repeated twice) Test food #3: 495.0 g Sprite™ soft drink plus 4 Sugardown™ tablet consumed with 250 mL water (repeated twice)
15935815|NCT03374501|Dietary Supplement|Soft drink|Test food #1: 495.0 g Sprite™ soft drink consumed with 250 mL water (repeated twice)
15935816|NCT03374488|Drug|Pembrolizumab|Pembrolizumab administered intravenously Day 1 of each cycle every 3 weeks.
15935817|NCT03374488|Drug|Epacadostat|Epacadostat administered orally twice daily.
15935818|NCT03374488|Drug|Placebo|Matching placebo administered orally twice daily.
15935819|NCT03374475|Drug|JNJ-42847922 20mg|Participants will swallow 20 mg (2*10 mg) JNJ-42847922 capsule orally for 5 weeks during treatment period.
15935820|NCT03374475|Drug|JNJ-42847922 40mg|Participants will swallow 40 mg (2*20 mg) JNJ-42847922 capsule orally for 5 weeks during treatment period.
15935821|NCT03374475|Drug|Placebo|All participants will receive matching placebo capsule during lead in period, treatment period and withdrawal period.
15935822|NCT03374462|Behavioral|Telemedicine Intervention|Home-based telemedicine visits
15935823|NCT03374449|Procedure|continuation of the RAS-inhibitors|drug intake
15935824|NCT03374449|Procedure|discontinuation of the RAS-inhibitors|no drug intake
15935825|NCT03374436|Behavioral|High-Carbohydrate Sedentary|Three high-carbohydrate meals will be consumed (breakfast, lunch, and dinner) at ~3 hour intervals while participants remain in a seated position for the entire 9 hour intervention period.
15935826|NCT03374436|Behavioral|High-Carbohydrate Active|"Three high-carbohydrate meals will be consumed (breakfast, lunch, and dinner) at ~3 hour intervals while participants remain in a seated position for the entire 9 hour intervention period except that once every hour they will ascend three flights of stairs vigorously (stair climbing sprint snack) for a total of 8 active breaks."
15935827|NCT03374436|Behavioral|Low-carbohydrate Sedentary|Three low-carbohydrate meals will be consumed (breakfast, lunch, and dinner) at ~3 hour intervals while participants remain in a seated position for the entire 9 hour intervention period. This condition will provide a condition where the blood glucose and insulin responses are relatively low and stable throughout the day.
15935828|NCT03374423|Procedure|radiofrequency|"The procedure will be done under propofol sedation, under fluoroscopic guidance. The image intensifier will be rotated in a cephalo-caudal direction until the endplates of the thoracic vertebrae are aligned and the transverse processes became discernable from the ribs.
~For the intercostal nerve group, the radiofrequency needle 10 cm with 10 ml active tip will then inserted to contact the lower edge of the transverse process of (T2-T5), the needle is walked off to obtain sensory stimulation between 0.3-0.6 mv and motor stimulation less than 1.2 mv .five cycle of pulsed radiofrequency will be delivered."
15935829|NCT03374423|Procedure|radiofrequency|The procedure will be done under propofol sedation, under fluoroscopic guidance.for dorsal root ganglion group, radiofrequency needle 10 cm with 10 ml active tip will inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walked into the thoracic intervertebral foramen. Once correct needle position is confirmed, test stimulation will be performed at 50 Hz, during which time the needles will slightly redirected to optimize stimulation, the point of maximum stimulation will be designated to be the location of the dorsal root ganglion. five cycle of pulsed radiofrequency will be delivered.
15935830|NCT03374397|Drug|Surgiguard|Hemostasis with Surgiguard during laparoscopic unilateral ovarian cystectomy
15935831|NCT03374384|Other|No drug intervention|This study will be performed in Al-Arish Central Hospital and will include all patients from 2 months up to 18 years of age with seizures admitted to Al-Arish Central Hospital
15935832|NCT03374371|Diagnostic Test|high-throughput sequencing|technique of high-throughput sequencing of the markers present in the genome of the S. epidermidis strains responsible for infection in order to help to discriminate the true infections of the contaminations
15935833|NCT03374358|Drug|Raltegravir|The aim of this study is to investigate whether switching a protease inhibitor (PI) or efavirenz to raltegravir has effect on liver fat and metabolism in HIV-infected patients who are overweight or obese and have at least one metabolic syndrome component .
15935834|NCT03374345|Drug|Sipjeondaebo-tang Granule|3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
15935835|NCT03374345|Drug|Placebo|3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
15935836|NCT03374332|Drug|Gemtuzumab Ozogamicin (GO)|Patients will be given gemtuzumab ozogamicin on days 1,4, and 7. Capped at 4.5mg individual doses. Total doses capped at 13.5mg.
15935837|NCT03374332|Other|Donor Leukocytes|The product will be administered unprocessed on day 8/24 hours post GO (same day as leukapheresis) with a minimum of CD3+ cells and maximum of CD3+ cells/kg irrespective of the number of CD34+ cells.
15935871|NCT03374072|Behavioral|Information Only Condition|Siblings will be provided with written information about services for adults with ASD and future planning.
15935872|NCT03374059|Other|Exercise program|
15935873|NCT03374059|Other|Life modification|
15935874|NCT03374046|Procedure|Apneic Oxygenation|Supplemental oxygen will be provided via nasal cannula during intubation attempt
15935875|NCT03374033|Dietary Supplement|NUTR +|one extra g/kg/d of protein and lipids starting before 48 hours after birth until 36 weeks postmenstrual age
15935986|NCT03373188|Biological|Nivolumab|Given IV
15935838|NCT03374319|Procedure|Modified amputation procedure|A stair-step (BKA) or fishmouth (AKA) incision will be made. Tibial and fibular or femoral osteotomies will be performed. Segments of the tibialis anterior (TA), peroneus longus (PL), lateral gastrocnemius (LG) and tibialis posterior (TP) muscles will be isolated, as well as the quadriceps (Q) and hamstring (H) groups in the AKA model; if it is not possible to preserve native innervation to these muscles, functional motor units will be constructed from muscle coapted to the appropriate motor nerve endings. The distal tibial and peroneal nerves will be redirected to skin patches in the distal or proximal thigh. Coaptation of the TA/LG, PL/TP and Q/H muscles will then be performed to promote dynamic coupling of these agonist/antagonist pairs. The skin envelope will then be closed in layers over percutaneous drains.
15935839|NCT03374319|Procedure|Amputation procedure with TMR and/or RPNI construction|Amputation is performed via standard techniques at either the BKA or AKA level, incorporating either targeted muscle reinnervation or the construction of regenerative peripheral nerve interfaces, or both. No construction of agonist-antagonist muscle pairs will be performed.
15935840|NCT03374306|Drug|Atropine (0.01%)|tropical application
15935841|NCT03374306|Drug|Artificial tear|tropical application
15935842|NCT03374293|Radiation|Radiation|RT to 45-50.4 Gy, 5 x per week, 1.8Gy/fx. Radiation begun the day after the first dose of anti-PD-1 antibody .
15935843|NCT03374293|Drug|Anti-PD-1 Antibody|Anti-PD-1 antibody (every 2 weeks for 5 cycles) will be administered as an intravenous infusion over 30 minutes.
15935844|NCT03374280|Drug|pemetrexed/cisplatin intercalating gefitinib|
15935845|NCT03374280|Drug|pemetrexed/cisplatin|
15935847|NCT03374254|Biological|Pembrolizumab|200 mg Pembrolizumab solution for IV infusion Q3W
15935848|NCT03374254|Drug|Binimetinib|tablet orally BID at 30 or 45 mg depending upon DLT profile
15935849|NCT03374254|Drug|Oxaliplatin|85 mg/m^2 as IV infusion. Administered Q2W as part of mFOLFOX7 cocktail. Dose may be de-escalated to 70 mg/m^2 if the standard dose of mFOLFOX7 is deemed too toxic per mTPI, based upon occurrence of DLTs.
15935850|NCT03374254|Drug|Leucovorin|400 mg/m^2 as IV infusion. Administered Q2W as part of mFOLFOX7 or FOLFIRI cocktail, depending upon allocation.
15935851|NCT03374254|Drug|5-Fluorouracil [5-FU]|2400 mg/m^2 over 46-48 hours as IV infusion. Administered Q2W as part of mFOLFOX7 or FOLFIRI cocktail, depending upon allocation. Dose may be de-escalated to 2000 mg/m^2 if the standard dose of mFOLFOX7 or FOLFIRI is deemed too toxic per mTPI, based upon occurrence of DLTs.
15935852|NCT03374254|Drug|Irinotecan|180 mg/m^2 as IV infusion. Administered Q2W as part of FOLFIRI cocktail. Dose may be de-escalated to 150 mg/m^2 if the standard dose of FOLFIRI is deemed too toxic per mTPI, based upon occurrence of DLTs.
15935853|NCT03374241|Biological|HM15211 or Placebo|Long-acting tri-agonist
15935854|NCT03374228|Drug|BMS-986205|Specified Dose on Specified Days
15935855|NCT03374202|Drug|VRC-HIVAAV070-00-GT (AAV8-VRC07)|AAV8-VRC07 is a recombinant AAV vector expressing a HIV-1 CD4 binding site-specific neutralizing antibody, VRC07.
15935856|NCT03374189|Device|EZ close|EZ close used.
15935857|NCT03374189|Device|Carter Thomason|Carter Thomason used.
15935858|NCT03374176|Drug|Amoxicillin 500 mg / Metronidazole 250 mg|Subjects were instructed to take a capsule three times a day for 7 days
15935859|NCT03374176|Drug|Clindamycin 300 mg|Subjects were instructed to take a capsule three times a day for 7 days
15935860|NCT03374163|Drug|intralipid 20%|milky soulation for energey supplement.
15935861|NCT03374150|Behavioral|diet counseling|Subjects were given nutrition consultation, diet recipes, and logbook. Counseling was performed once weekly. During 8 weeks of diet program, subjects were instructed to reduce their daily caloric intake by 500 - 1000 kcal from their previous usual daily intake with limitation in low calorie diet range (800-1500 kcal.day) of calorie intake.Follow-up for each subject was performed once daily by person-to-person encounter. Besides, subjects were contacted by everyday cellphone texting and telephone twice a week to control subject's compliance. After 8 weeks of intervention, subjects were invited to revisit the clinic for anthropometry and body composition measurement after completing the program.
15935863|NCT03374124|Diagnostic Test|sinonasal outcome test-22|Evaluate the nasal mucosal inflammation condition and overall quality-of-life of CRS patients
15935864|NCT03374111|Drug|Colla corii asini|15 g Colla corii asini granule daily for 8 weeks
15935865|NCT03374111|Drug|a Simulate Agent of Colla corii asini granule|15 g a Simulate Agent of Colla corii asini granule daily for 8 weeks
15935866|NCT03374098|Behavioral|Home Visitiation|"The home visit component of the intervention will involve a visit to participants' homes by a social worker, who will assist patients dealing with other health and social problems. Participants will be followed for a minimum of 10 weeks, and additional follow-up visits will be at the discretion of the social worker. They will work with community partners and refer patients when appropriate.
~Community partners could include: Domestic violence services, employment placement, benefit enrollment, community action agency (bill pay, utilities), ACA enrollment, homeless shelter, housing authority, re-housing program"
15935867|NCT03374098|Behavioral|Education|"The education component of the intervention will include attending a class once per week for 3 weeks. Classes will be led by a dietician, and may also involve other members of an interdisciplinary team including nurse practitioners, health educators, and community members. Education sessions will be held at 5:30pm on Mondays or Tuesdays, and participants will be provided with a meal. Topics will include:
~Week 1 (5:30-6:30pm): Importance of self-management of disease, glucometer testing for blood sugars and using home blood pressure monitors, diabetes medication review
~Week 2 (5:30-7:00pm): Diabetes and Healthy Eating and Exercise - carbohydrate counting, portion control, lifestyle activity, and exercise demonstration activity
~Week 3 (5:30-6:30pm): Grocery shopping guidelines, label reading, hands on cooking demo"
15935868|NCT03374085|Drug|CC-92480|CC-92480
15935869|NCT03374085|Drug|Dexamethasone|Dexamethasone
15935870|NCT03374072|Behavioral|Siblings FORWARD program|Siblings will participate in a program developed by the researchers designed to engage adult siblings with their brother or sister with ASD and other family members to plan for the future. The Siblings FORWARD program will be implemented by community service providers already working with adults with ASD. The program will involve a series individual and joint sessions with siblings and adults with ASD using videoteleconferencing software.
15935876|NCT03374033|Behavioral|STIMUL +|Physical activity stimulation consists in flexion/extension of the 4 limbs and other motion exercises of the shoulder girdle and of the hips. This stimulation will take place before the feed for a mean of 30 times a week (minimum 24- maximum 36 times a week, 10 minutes each time) and will start within the 10th day of life until 36 weeks postmenstrual age
15935877|NCT03374020|Device|Notal OCT|Imaging using Notal OCT
15935878|NCT03374007|Biological|Geptanolimab Injection 1mg/kg|single-dose:1mg/kg
15935879|NCT03374007|Biological|Geptanolimab Injection 3mg/kg|single-dose: 3mg/kg
15935880|NCT03374007|Biological|Geptanolimab Injection 10mg/kg|single-dose:10mg/kg
15935881|NCT03374007|Biological|Geptanolimab Injection 1mg/kg, q2w*6|multiple dosing: 1mg/kg, q2w*6
15935882|NCT03374007|Biological|Geptanolimab Injection 3mg/kg, q2w*6|multiple dosing: 3mg/kg, q2w*6
15935883|NCT03374007|Biological|Geptanolimab Injection 10mg/kg, , q2w*6|multiple dosing: 10mg/kg, , q2w*6
15935884|NCT03374007|Biological|Geptanolimab Injection 280mg, q3w|multiple dosing: 280mg, q3w
15935885|NCT03374007|Biological|Geptanolimab Injection 3mg/kg, q2w|multiple dosing: 3mg/kg, q2w
15935886|NCT03373994|Diagnostic Test|18F-FDG PET/CT initial-time imaging|18F-FDG intravenous bolus injection after a fasting perid of more than 6 hours, simultaneously,PET/CT imaging using one bed lasting 5 minutes was underwent.
15935887|NCT03373994|Diagnostic Test|18F-FDG PET/CT balanced-time imaging|18F-FDG intravenous injection after a fasting perid of more than 6 hours. After 60 minutes, PET/CT imaging using 6-7 bed positions each lasting 2 minutes was underwent.
15935888|NCT03373981|Device|rTMS|repetitive transcranial magnetic stimulation
15935889|NCT03373968|Drug|Givinostat|suspension of givinostat (10 mg/mL)
15935890|NCT03373955|Drug|pembrolizumab|anti-programmed death 1 (PD-1) antibody
15935891|NCT03373942|Other|Choroidal thickness measurements with SD-OCT device|
15935892|NCT03373929|Device|PFO Closure Rate|Suture Mediated PFO Closure and Septal Repair
15935893|NCT03373929|Device|Published PFO Device Closure|Suture Mediated PFO Closure and Septal Repair
15935894|NCT03373916|Behavioral|Peer mentorship|The peer mentor will meet with the participant for the first time while the participant is still in the hospital. Sessions will be scheduled according to the participant's preferences, with a suggested maximum frequency of twice weekly for the first two weeks, weekly for weeks 3 to 8, and then every other week for the last month. Allowable meeting locations include public places in the community (e.g., coffee shop, park), the participant's home, or a research clinic space or by phone. Session content is flexible and allows for the peer mentor to provide general supportive listening, validation, and sharing. Session duration is on average 1 hour with at least 15 minutes discussing hope or belongingness according to semi-structured conversation guides. The session structure and content are intentionally highly flexible to allow for genuineness in the peer relationship, thereby increasing acceptability and implicit belongingness.
15935895|NCT03373916|Behavioral|Enhanced Usual Care|"The EUC condition will consist of a caring message from the study team via e-mail or text message (based on the participant's preference) 24-72 hours after discharge. An example message is, We hope things are going well for you since you left the hospital. If you wish to reply, we'd be glad to hear from you. A list of local mental health resources will be available if participants reply and during the 3 and 6-month follow-up assessments. The EUC condition is modeled on prior studies of caring letters and brief contacts by health professionals after suicidal crisis and national recommendations to provide post-crisis follow-up contacts."
15935896|NCT03373903|Other|Placebo|oral
15935897|NCT03373903|Drug|BEZ235|oral
15935898|NCT03373903|Drug|BEZ235 plus everolimus (RAD001)|Oral
15935899|NCT03373890|Behavioral|Short Burst Interval Locomotor Treadmill Training (SBLTT)|SBLTT consists of interval training consisting of short-bursts (30 seconds) of vigorous intensity locomotor treadmill training (LTT) alternating with low to moderate intensity LTT.,
15935900|NCT03373877|Drug|PU-H71|PU-H71 treatments will be administered by IV infusion on days 1, 8, and 15 of each 28-day cycle.
15935901|NCT03373877|Drug|Ruxolitinib|Dosing will be in accordance with current package insert and dose subject was on during study entry.
15935902|NCT03373864|Procedure|Unilateral spinal anesthesia|Unilateral spinal anesthesia with hypobaric local anesthesia allowing a lateralized anesthesia of the fractured limb.
15935903|NCT03373864|Procedure|General anesthesia|General anesthesia following the latest recommendations for elderly patients (SFAR 2017)
15935904|NCT03373851|Device|Zalviso Device|"The Zalviso device will be provided immediately before the Post anesthesia care unit (PACU) discharge. Patients will be queried every day during three postoperative days for the ability to use the device, their satisfaction, the level of pain, and the incidence of side effects. There will be no changes in usual care.
~In the end of this study ward nurses carrying Zalviso patients will be asked to provide their usability and satisfaction evaluation for Zalviso device management. Physical therapist will be asked to provide their satisfaction regarding patients' ability to follow physical therapy program."
15935905|NCT03373838|Other|Census|Survey and interview
15935906|NCT03373825|Behavioral|Take home rapid drug test|The Rapid Response fentanyl test strips will be offered as take-home rapid drug tests to all participants to assess the willingness to use take-home rapid drug tests and the feasibility of using such an intervention at home. Arm 1 will be offered one method of using the take-home rapid drug test (urine testing). Arm 2 will be offered a second method of using the take-home rapid drug test (testing drug residue).
15935907|NCT03373812|Procedure|Blepharoptosis repair|levator advancement or mullerectomy
15935908|NCT03373799|Other|Video-Based Rehabilitation Program|In both groups, a program consisting of exercises used in conservative treatment of rotator cuff tears was performed. A video record was made by the physiotherapist to a patient where each exercise was described in detail and the patient correctly performed the exercises according to the verbal and visual commands of the physiotherapist. This video record watched by the patients who come to the clinic and patients were asked to do the exercises in the video. Patients did the exercises under control of the physiotherapist in the clinic.
15935909|NCT03373799|Other|Physiotherapist-Supervised Rehabilitation Program|In both groups, a program consisting of exercises used in conservative treatment of rotator cuff tears was performed. Program was carried out by teaching the same exercises individually by the physiotherapist.
15935910|NCT03373786|Drug|RG012|RG012 in 0.3% sodium chloride
15935911|NCT03373773|Device|Foley catheter|After reinsertion of the Foley catheter, both groups of women will be given instructions on urinary catheter and bag management, this will be done by an RN as per standard protocol. Prior to discharge, every subject from the home removal group as well as their significant other/caregiver/family member will receive a standardized education session and written and illustrated instructions on Foley catheter removal from RN, per standard protocol. They will be provided with the syringe for catheter removal, urine collection pan, and a diary to record their voiding quality and quantity. Both groups of women will have the catheter removal in 2 days.
15935912|NCT03373760|Biological|Durvalumab|Given IV
15935913|NCT03373760|Other|Laboratory Biomarker Analysis|Correlative studies
15935914|NCT03373760|Biological|Tremelimumab|Given IV
15935915|NCT03373747|Diagnostic Test|Reliability of IET|The participants will be do three sessions: familiarization, test and retest to assess the reliability inter and intra rater of the test.
15935916|NCT03373747|Diagnostic Test|Physiological analysis of IET|The participants will be submitted two sessions, familiarization session and test session. In the test session there will be the physiological analysis by means of gas analysis, blood lactate concentrate and activation muscular percentage.
15935917|NCT03373734|Device|Enjoy Your Bump|Online life skills course based on Cognitive Behavioural Therapy Principles.
15935918|NCT03373708|Drug|Epirubicin|100mg/m2
15935919|NCT03373708|Drug|Cyclophosphamide|600mg/m2
15935920|NCT03373708|Drug|Docetaxel|75mg/m2(TC), 100mg/m2(EC-T)
15935921|NCT03373708|Drug|Goserelin acetate|3.6mg every month
15935922|NCT03373708|Drug|Tamoxifen|10mg twice daily oral
15935923|NCT03373708|Drug|Letrozole|2.5mg every daily oral
15935924|NCT03373695|Device|Dissolve™|Dissolve™ are to be used in the trial
15935925|NCT03373695|Device|SeQuent®Please|SeQuent®Please are to be used in the trial
15935926|NCT03373669|Biological|Oral Cholera Vaccine|Shanchol is a bivalent (O1 and O139 serotypes) vaccine using a heat-killed classical Inaba strain and a formalin-killed classical Ogawa strain produced by Sanofi. Shanchol requires no oral buffer for administration, is approved for persons greater than 1 year of age, and requires 2 doses at two-week intervals. It became World Health Organization (WHO) prequalified in 2011.
15935927|NCT03373669|Biological|Adjusted Dose Oral Cholera Vaccine|The Adjusted Dose Oral Cholera Vaccine is given in two doses, with the second dose given at six months, rather than the manufacturer described 2 week interval between first and second dose.
15935928|NCT03373656|Biological|Vaccination|"Patients with higher antibody titers will accept vaccination. There are two vaccines provided in this study:
~hepatitis B vaccine measles-rubella combined vaccine"
15935929|NCT03373656|Other|No Vaccination|Patients with higher antibody titers will NOT accept vaccination. But we will keep monitoring their antibody titers.
15935930|NCT03373643|Diagnostic Test|OSA screening|Full night polysomnography
15935931|NCT03373630|Device|Midline catheter|The catheter will be inserted according to usual practices, after the enrollment of the patient in the study. The follow-up will last until the removal of the catheter, which will also be done according to usual practices. Following the removal, bacteriologic analyses will be performed in order to diagnose any prospective infection.
15935932|NCT03373604|Drug|18F-MK-6240|18F-MK-6240 is a PET radioligand that binds abnormal tangles made of the protein tau. These tau tangles develop in the brain in people with Alzheimer's disease.
15935933|NCT03373604|Procedure|Lumbar Puncture (optional)|Subjects have the option to have lumbar puncture performed for the measurement of Alzheimer's disease biomarkers in cerebrospinal fluid.
15935934|NCT03373591|Drug|Liposomal Bupivacaine TAP block|Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
15935935|NCT03373591|Drug|Bupivacaine TAP block|Infiltration of the transverse abdominis peritoneum by a local anesthetic under laparoscopic visualization.
15935936|NCT03373578|Device|earmuffs|to compare the neonate's sleep with and without earmuffs during Quiet time at the NICU
15935937|NCT03373565|Procedure|Radial|Coronary angiography using radial approach
15935938|NCT03373565|Procedure|Palmar|Coronary angiography using radial approach
15935939|NCT03373552|Diagnostic Test|Platelet function assay|Platelet function assay
15935940|NCT03373526|Other|Inspiratory Muscle Training|The Inspiratory Muscle Training will be perform using using the Power Breathe® device, during 20 minutes daily, five times a week. The protocol will be performed in the sitting position with an established load of 40% of maximal inspiratory pressure.
15935941|NCT03373526|Other|Aerobic Training|The aerobic physical training will be perform using a cycle ergometer, during 20 minutes daily, five times a week, with moderate intensity (50-70% of reserve heart rate).
15935942|NCT03373513|Procedure|Robotic single-site Hysterectomy|Robotic assisted Periumbilical single incision hysterectomy
15935943|NCT03373513|Procedure|Laparoscopic hysterectomy|Multiport laparoscopic hysterectomy
15935944|NCT03373500|Other|Dietary salt reduction|Patients will be given intensive dietary advice to achieve a low salt diet, targeting a dietary salt intake of less than 5g per day (80 mmol/day).
15935945|NCT03373487|Behavioral|The cognitive rehabilitation program ReMind|Cognitive rehabilitation, i.e. psychoeducation, strategy training & retraining
15935946|NCT03373474|Other|local distribution points association|"Participants will receive acupuncture treatments using the local points set plus the local-addition points set (local distribution association) described below. Warming acupuncture will be applied at HT2, LI11, and TE9 if permitted.
~Local points set: TE5, LI11, TE9, HT3, TE13, and Xiajiquan on the affected arm. Local-addition points set: LU5, PC3, SI7, TE4, TE3, HT2, TE10, LI15, and 2 other points according to the symptom on the affected arm."
15935947|NCT03373474|Other|local-distal points association|"Participants will receive acupuncture treatments using the local points set plus the distal points set (local-distal association) described below. Warming acupuncture will be applied similarly to the local distribution group, with the addition of Ren6, Ren9, bilateral SP9, and LI11 on the unaffected arm.
~Local points set: TE5, LI11, TE9, HT3, TE13, and Xiajiquan on the affected arm. Distal points set: TE5, LI11, HT3, TE13 on the unaffected arm; CV4, CV6, CV9, CV12, bilateral SP6 and SP9."
15935948|NCT03373461|Drug|LNP023|LNP023 b.i.d. Dose 1, Dose 2 and Dose 3
15935949|NCT03373461|Drug|Placebo|Placebo to LPN023 b.i.d
15935981|NCT03373214|Biological|CPG 10104|CPG 10104
15935982|NCT03373201|Drug|Tasimelteon|Oral capsule
15935950|NCT03373448|Device|Labrida BioClean|The implant pockets will be debrided with the BioClean™ biodegradable brush for 2 minutes and with the brush seated in an oscillating dental handpiece (NSK ESQ10 TEQ) and thereafter irrigated with sterile saline or commercially available and area-specific titanium curettes (Langer and Langer, Rønvig) for 2 minutes and thereafter irrigated with sterile saline. The treatment will be repeated every three months until the terminal examination after 24 months. Debridement is performed with local anaesthesia as needed. Healthy sites will not be retreated.
15935951|NCT03373448|Other|Titanium curettes|Peri-implant pockets will be debrided using titanium curettes.
15935952|NCT03373435|Drug|exendin 9-39|Exendin 9-39 is a competitive antagonist of GLP-1 at its receptor.
15935953|NCT03373435|Other|Placebo|Placebo solution is identical to the active drug product except for the absence of the active ingredient, Exendin 9-39.
15935954|NCT03373422|Drug|BAY1128688|Various dosing OD (once daily) and BID (twice daily)
15935955|NCT03373422|Drug|Placebo|Matching placebo tablets
15935956|NCT03373409|Drug|Albuterol DPI 90mcg|Albuterol unit dose disposable DPI delivers 90mcg of albuterol in the excipient lactose with each inhalation. Albuterol 90mcg will be given on one of the 3 treatment days. One inhalation from the DPI will be used.
15935957|NCT03373409|Drug|Albuterol DPI 180mcg|Albuterol unit dose disposable DPI delivers 90mcg of albuterol in the excipient lactose with each inhalation. Albuterol 180mcg will be given on one of the 3 treatment days. Two inhalations from the DPI will be used to deliver the 180mcg dose
15935958|NCT03373409|Drug|Albuterol HFA MDI|Albuterol HFA MDI delivers 90mcg of albuterol with each inhalation. Albuterol 180mcg will be given on one of the 3 treatment days. Two inhalations from the MDI will be used to deliver the 180mcg dose
15935959|NCT03373396|Diagnostic Test|Blood samples|Collected data will contain epidemiological and biological data, blood samples with chlordecone dosage.
15935960|NCT03373383|Drug|Padsevonil|Padsevonil in different dosages.
15935961|NCT03373383|Other|Placebo|Placebo will be provided matching Padsevonil.
15935962|NCT03373357|Other|Patient not SAHOS|"Phone consultation in 1 month, 3mois, then every 6 months, and an annual visit.
~Cardiovascular events arisen during the duration of the study
~Modifications of the lifestyle: alcohol, physical activity
~Weight
~Clinical measure of the PA
~Clinical examination
~The collection of the cardiovascular events arisen during the duration of the study will be realized for all the inclusive patients"
15935963|NCT03373357|Other|Patient SAHOS sailed by the ventilation in PPC and not sailed|"Questionnaire of subjective evaluation of diurnal slumber: scale of Epworth and search for appearance of at least 2 of the following symptoms: sleep not salvage dealer, night-breathlessnesses, multiple awakenings, fatigue, disordersconfusions, nycturie, snore.
~Questionnaire of evaluation of the global quality of life of the SAHOS
~Appearance of new cardiovascular risk factors
~Cardiovascular events arisen during the duration of the study
~Modification of the current treatments
~Modifications of the lifestyle: alcohol, physical activity
~Weight
~Clinical measure of the PA
~Clinical examination
~The collection of the cardiovascular events arisen during the duration of the study will be realized for all the inclusive patients"
15935964|NCT03373344|Behavioral|Emotional Processing Training|Participants in the experimental group will receive computerized exercises administered on a laptop computer. They will undergo 12 sessions of 45-60 minutes each (twice a week for 6 weeks).
15935965|NCT03373344|Behavioral|Placebo control exercises|Participants in the control group will receive computerized control exercises administered on a laptop computer. They will undergo 12 sessions of 45-60 minutes each (twice a week for 6 weeks).
15935966|NCT03373331|Behavioral|Emotional Processing Training|Participants in the experimental group will receive computerized exercises administered on a laptop computer. They will undergo 12 sessions of 45-60 minutes each (twice a week for 6 weeks).
15935967|NCT03373331|Behavioral|Placebo Control Exercises|Participants in the control group will receive computerized control exercises administered on a laptop computer. They will undergo 12 sessions of 45-60 minutes each (twice a week for 6 weeks).
15935968|NCT03373318|Drug|Human albumin|Single dose as a primer for the CEC, in sufficient quantity to reach a concentration of 4% of the total volume of priming.
15935969|NCT03373318|Drug|Plasmalyte|The dose and the speed of administration depend on the age, weight, clinical and biological status of the patient and the concomitant treatment. The recommended dose for adults, the elderly and adolescents: from 500 ml to 3 liters / 24 hours.
15935970|NCT03373305|Drug|Brentuximab Vedotin|Given IV
15935971|NCT03373305|Drug|Lenalidomide|Given PO
15935972|NCT03373305|Other|Laboratory Biomarker Analysis|Correlative studies
15935973|NCT03373292|Procedure|Venous stenting for internal jugular vein stenosis|"After confirming the diagnosis of IJVS by Jugular Vein Doppler Ultrasound, Magnetic Resonance Venography (MRV) and/or Computed Tomography Venography (CTV), and excluding external compression-induced stenosis as well as other causes of intracranial pressure elevation, patients will be divided into two groups randomly (30 for each group: group-1 and group-2).
~Patients in Group-1 will receive Digital Subtraction Angiography (DSA) immediately after enrollment, and trans-stenotic pressures (∆MPGs) will be measured, balloon angioplasty bridging venous stenting will be performed when their ∆MPGs of jugular veins are equal to or greater than 5.44 cmH₂O (4 mmHg)."
15935974|NCT03373292|Procedure|One-month routine medical treatment followed by venous stenting for internal jugular vein stenosis|"Patients in Group-2 will receive routine medical treatment for one month. Afterwards, they will undergo DSA (the procedure is the same as that in Group-1).
~Notably, patients in Group-2 with medical uncontrolled intracranial hypertension will be provided stenting of their jugular veins at any time during the one-month routine medical treatment, in attempt to reduce their intracranial pressure and ameliorate visual damages in time."
15935975|NCT03373266|Drug|Sevoflurane|anesthesia was maintained with Sevoflurane 1-2%.
15935976|NCT03373266|Drug|Isoflurane|anesthesia was maintained with isoflurane 1-2%.
15935977|NCT03373240|Behavioral|TAU plus Cognitive Remediation Program|Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on cognitive-affective self-regulatory processes.
15935978|NCT03373240|Behavioral|TAU plus Control Tasks|Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.
15935979|NCT03373227|Drug|Envarsus|Patients will take once daily Envarsus
15935980|NCT03373214|Biological|Na-GST-1|Na-GST-1/Alhydrogel®
15935987|NCT03373188|Procedure|Surgery|Undergo therapeutic conventional surgery
15935988|NCT03373175|Device|Basal record|Basal EMG record will be performed during 5 minutes. This record must be the same in both ventilators.
15935989|NCT03373175|Device|PS 10 record|PS 10 EMG record record will be performed during 5 minutes. First with ventilator 1 and then with the other. The patient must be rest at least 5 minutes to recover basal record
15935990|NCT03373175|Device|PS 15 record|PS 15 EMG record record will be performed during 5 minutes. First with ventilator 1 and then with the other. The patient must be rest at least 5 minutes to recover basal record
15935991|NCT03373175|Device|PS 20 record|PS 20 EMG record record will be performed during 5 minutes. First with ventilator 1 and then with the other. The patient must be rest at least 5 minutes to recover basal record
15935992|NCT03373162|Drug|onabotulinumtoxinA|This study is a pre- and post-design. One scan will be collected prior to BOTOX injection and the second will be collected 14-21 days post-injection. BOTOX injections will be limited to 20 units in the glabellar area, as approved by the FDA .
15935993|NCT03373149|Drug|Growth hormone/HPuFSH/GnRH antagonist|"Growth hormone (Somatropin, Sedico, Egypt) [4 IU/day] and highly purified urinary FSH (HPuFSH) (Fostimon,IBSA, Switzerland) [300 IU/day] will be started on cycle day 3 and will be continued until and including the day of human chorionic gonadotropin (HCG) administration. Starting from cycle day 8, the dose of HPuFSH will be adjusted individually according to ovarian response which will be monitored using transvaginal ultrasound and serum estradiol (E2).
~GnRH antagonist (Cetrorelix acetate) (Cetrotide; Serono International S.A., Geneva, Switzerland) 0.25 mg S.C. once daily will be started when the leading follicle is 14 mm in mean diameter and will be continued until and including the day of HCG administration."
15935994|NCT03373149|Drug|HPuFSH/GnRH antagonist|"Highly purified urinary FSH (HPuFSH) (Fostimon,IBSA, Switzerland) [300 IU/day] will be started on cycle day 3 and will be continued until and including the day of human chorionic gonadotropin (HCG) administration. Starting from cycle day 8, the dose of HPuFSH will be adjusted individually according to ovarian response which will be monitored using transvaginal ultrasound and serum estradiol (E2).
~GnRH antagonist (Cetrorelix acetate) (Cetrotide; Serono International S.A., Geneva, Switzerland) 0.25 mg S.C. once daily will be started when the leading follicle is 14 mm in mean diameter and will be continued until and including the day of HCG administration."
15935995|NCT03373136|Device|Polypectomy|Polypectomy during colonoscopy is considered effective to reduce the incidence and mortality of colorectal cancer
15935996|NCT03373123|Procedure|Endoscopy|Endoscopy
15935997|NCT03373123|Procedure|CTA|Radiomic features were extracted from CTA images.
15935998|NCT03373110|Behavioral|Online Mindfulness Based Cognitive Therapy|see arm description
15935999|NCT03373110|Behavioral|Online Cognitive Behavioral Therapy|see arm description
15936000|NCT03373110|Behavioral|Fitbit Alone|see arm description
15936001|NCT03373097|Biological|GD2-CART01|Following a lymphodepleting treatment with conventional chemotherapy, patients will be treated with 1.0 to 10.0 x 10⁶/kg GD2 Chimeric Antigen Receptor (CAR) positive T cells as a single dose.
15936002|NCT03373084|Other|Magnetic Resonance Imaging (MRI)|Magnetic Resonance Imaging (MRI) or ultrasound will be performed to determinate location of the lesion
15936003|NCT03373084|Other|ultrasound|Magnetic Resonance Imaging (MRI) or ultrasound will be performed to determinate location of the lesion
15936004|NCT03373084|Other|Self-questionnaire|Self-questionnaire will be completed by patient. In this questionnaire patients will describe the circumstances of the injury and their personal characteristics and level of sporting practice.
15936005|NCT03373071|Biological|CD19-CAR T cell|"Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with 0.5 to 3.0 x 10⁶/kg CD19 Chimeric Antigen Receptor (CAR) positive T cells as a single dose.
~In case of toxicity, the patient will receive the dimerizing drug activating the suicide safety switch in order to improve the safety of the treatment"
15936006|NCT03373058|Procedure|Hyperthermic Intraperitoneal Chemotherapy|HIPEC is performed as postoperative chemotherapy after cytoreductive surgery for advanced-stage epithelial ovarian cancer. The first HIPEC is conducted within 48h after cytoreductive surgery: Paclitaxel 175 mg/m^2, 43°C, 90min. The second HIPEC is performed after 48 hours of the first HIPEC. The HIPEC regimens are Docetaxel 75 mg/m^2 and cisplatin 75 mg/m^2, respectively, 43°C, 90min.
15936007|NCT03373058|Procedure|cytoreductive surgery|Cytoreductive surgery (CRS) is performed when Faggoti value is less than 6 via laparoscopic exploration.
15936008|NCT03373058|Drug|adjuvant chemotherapy|"Systemic chemotherapy regimens after HIPEC treatment are paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks for 2 cycles in experimental group.
~Systemic chemotherapy regimens after IDS are paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks for 3 cycles in control group."
15936009|NCT03373032|Other|Stiper|"Stiper silicon tablets, for acupunture's stimulation of meridian points, the Stiper's chemical composition is nothing more than SiO 2 - (silicon dioxide) the shape of the quartz stone (silicon rich).They will perform the treatment with the Stiper silicon inserts, which will be applied and fixed by plasters at the acupuncture points, duration of 05 minutes."
15936010|NCT03373032|Other|Acupuncture|Treatment with a systemic needle to stimulate meridian acupuncture points, treatment begins with asepsis with 70% alcohol-soaked cotton in the region of the acupoints and then sterile and disposable needles (0.25 mm x 30 mm) will be inserted in both limbs, will be placed in the following regions: shoulders, thorax, legs and feet with the puncture order from bottom to top,duration of 30 minutes.
15936011|NCT03373032|Other|Exercise|Will perform pre-defined kinesiotherapy based on the stretching of cervical musculature and scapular waist, lumbar spine and lower limbs with exercises for WM and upper limb (MS) and lower limb (MI) strength with a duration of 30 minutes.
15936012|NCT03373032|Other|Follow Up|Use of the therapeutic massager, in hands and feet, to stimulate region's sensitivity, women who were submitted to the chemotherapy treatment with Taxane and continued with changes in sensitivity. Once in each dermatome, adding time of 5 minutes of application on average.
15936013|NCT03373032|Other|Observation|The waiting room (observation) group did not receive any intervention. Conduct evaluations of the research protocol as groups A, B and C.
15936014|NCT03373019|Drug|Chidamide combined with R-GDP|Chidamide: 30mg,PO,biw one week before cycle 1 treatment rituximab 375 mg/m2,ivgtt D0 gemcitabine 1000mg/m2 iv D1,8 dexamethasone 40mg, iv D1-4, cisplatin 25mg/m2 iv D1-4 chidamide :20mg PO Biw, 2 week on , 1 week off
15972483|NCT03094052|Drug|Neratinib|Given orally (PO)
15936015|NCT03373006|Drug|Axumin PET/CT|Synthetic amino acid uptake agent injection followed by imaging
15936016|NCT03372967|Biological|Vaccine administration by a pharmacist|Administration, number and types, of vaccines by a pharmacist
15936017|NCT03372967|Behavioral|Unmet vaccination needs identified and met|Identification of unmet vaccination needs and having those needs met
15936018|NCT03372967|Behavioral|Vaccination forecast review and patient education|Pharmacist review of the vaccination forecast and patient education on his/her vaccine needs
15936019|NCT03372954|Drug|BMAC|retrograde administration on non-selected BMAC via coronary sinus
15936021|NCT03372928|Dietary Supplement|Standard EAA|EAA provided relative to body mass at a standard dose (0.10 g/kg) during energy deprivation
15936022|NCT03372928|Dietary Supplement|High EAA|EAA provided relative to body mass at a high dose (0.30 g/kg) during energy deprivation
15936023|NCT03372915|Behavioral|Standard Exposure|Exposure therapy conducted according to standard clinical care practices
15936024|NCT03372915|Behavioral|Exposure + Inhibitory Learning|Exposure therapy conducted according to practice recommendations based derived from research on inhibitory learning theories of fear extinction
15936025|NCT03372902|Device|Breast MRI|Participants with dense breast tissue will get a mammogram and MRI
15936026|NCT03372902|Device|Breast Mammogram|State-of-the-art full-field digital mammography (FFDM) and or digital breast tomosynthesis (DBT) comprising both raw and post-processed images as well as ultrasound and MRI images from the initial screening study will be collected and sent to the MSKCC Breast Radiology Department.
15936027|NCT03372902|Other|Blood draw|Participants will donate approximately 60ml of peripheral blood. Mononuclear cells from peripheral blood will be used to extract germline DNA. Germline genomic testing will be employed as a matched control for tumor sequencing and for germline breast cancer susceptibility testing.
15936028|NCT03372902|Procedure|Breast Biopsy|Tissue specimens from the biopsy of the BI-RADS 4 mammographic lesion and (among women undergoing surgical excision) the surgical specimen(s) will be subjected to genomic profiling at GRAIL, Inc. or MSKCC. The tumor specimens from the participants diagnosed with cancer during the follow-up period will also undergo molecular profiling.
15936029|NCT03372902|Behavioral|online participant reported questionnaire|Participants will be asked to complete a questionnaire that covers the topics of breast health, general health and lifestyle, genetic testing, personal, and family history of cancer.
15936030|NCT03372889|Behavioral|Patient educaiton materials - Print based|Print (paper) based materials
15936031|NCT03372889|Behavioral|Patient educaiton materials - Media based|Media (electronic) based materials
15936032|NCT03372876|Dietary Supplement|Protein and carbohydrate supplementation|Participants were randomly assigned to protein-carbohydrate group (PC) (n=17), that ingested 30 g of whey protein immediately after exercise and 30 g of maltodextrin in the afternoon; and to carbohydrate-protein group (CP) (n=17), that ingested 30 g of maltodextrin immediately after exercise and 30 g of whey protein in the afternoon. Both groups performed the same resistance training protocol in the morning, 3 times a week, at 70% of 1-maximum repetition (1-RM) during 8 weeks.
15936033|NCT03372850|Drug|HIP1601|Test Drug
15936034|NCT03372850|Drug|HGP1705|Reference Drug
15936035|NCT03372837|Drug|Rituximab|The administration of rituximab at 375 mg/m^2/day by intravenous infusion on Day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
15936036|NCT03372811|Drug|TC cream|A well-characterized botanical drug for topical treatment of psoriasis vulgaris
15936037|NCT03372811|Drug|Vehicle|Vehicle
15936038|NCT03372798|Procedure|ICE/IVUS imaging during atrial fibrillation ablation|Intravascular ultrasound imaging of the left atrial wall thickness with ICE/IVUS during atrial fibrillation ablation
15936039|NCT03372785|Drug|aspirin, betaloc, atorvastatin, rosuvastatin, clopidogrel, ticagrelor|Optimal medical therapy includes dual antiplatelet therapy and statins (aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc). And optimal medical therapy should include adequate ventricular rate-limiting medication (i.e. Beta-blocker or rate-limiting calcium antagonist) where appropriate. Anti-anginal therapy should be used if the patients have symptom.
15936040|NCT03372785|Device|coronary wires. stents or coronary balloons|all species of drug-eluting stent ((such as Xience, Endeavor, Resolute) implantation or balloon expansion (POBA)
15936041|NCT03372772|Drug|Levocarnitine|Levocarnitine syrup- Oral supplementation about 2000mg/ day for 8 weeks
15936042|NCT03372759|Procedure|airtamponade|airtamponade is applicated in the study group air
15936043|NCT03372759|Procedure|saline|saline is left in the study Group saline
15936044|NCT03372733|Drug|control olive oil (COO)|2 capsules, 2 times a day after meals in a total of 4 capsules a day
15936045|NCT03372733|Drug|palmitoleate-rich oil (PLO)|2 capsules, 2 times a day after meals in a total of 4 capsules a day
15936046|NCT03372720|Procedure|Laser Therapy|Undergo fractional CO2 laser therapy
15936047|NCT03372720|Other|Questionnaire Administration|Ancillary studies
15936048|NCT03372720|Procedure|Sham Intervention|Undergo sham laser therapy
15936049|NCT03372707|Diagnostic Test|Cuff Leak Test|The Respiratory Therapist (RT) will perform the CLT on all enrolled patients. The patients will first be switched to volume assist-control (V-AC) with a respiratory rate of 10 breaths/min (to allow patient assist), constant flow of 60 l/min, and tidal volume set to match the average tidal volume currently being delivered during supportive ventilation. The RT will document the average exhaled volume over 3-5 breaths after switching to V-AC. The test will be performed by deflating the ETT balloon cuff with a 10 cc syringe, and: a) auscultation with a stethoscope to identify audible air leak around the ETT, and b) measuring the difference between the average exhaled volume prior to cuff deflation and the average exhaled volume over 3-5 breaths after cuff deflation.
15936083|NCT03372460|Device|Sham stimulation|For sham tDCS, the investigators will use the same configuration of active tDCS, with the anode over AF7 and the cathode over Fz. The investigators will use 3x3 cm sponge covered electrodes and 1mA for 30 seconds, with a ramp up/down over 30 seconds per session.
15936084|NCT03372460|Other|Virtual Reality (VR)|Participants will undergo VR exposure to trauma-related context.
15936050|NCT03372694|Behavioral|Rehabilitation Training|Patients will be trained in one month after operation. Rehabilitation training will be carried out between every two cycles of chemotherapy. Rehabilitation training is mainly composed of gymnastics qigong, which has long been regarded as a form of rehabilitation in Traditonal Chinese Medicine. According to the poor pulmonary function of patients with lung cancer after operation, Liu Zi Jue lung exercise is chosen to strengthen the pulmonary function of the human body in Chinese traditional health culture. Liu Zi Jue lung exercise intervention will be lead by an expert instructor, five times a week, 15 min/time.
15936051|NCT03372694|Drug|TCM|four types with functions such as benefiting Qi recipe, benefiting Yin recipe, harmonizing stomach recipe and detoxication and resolving masses recipe. Each package contained 20g of water-soluble herbal granules that were manufactured at a Good Manufacture Practice standard facility (Tian Jiang Ltd, Jiangyin, China). Each package was labeled with a serial number. The prescription form comprised the stock list with both the name and serial number.
15936052|NCT03372694|Other|Rehabilitation Education|General health education
15936053|NCT03372694|Drug|placebo|four types with functions such as benefiting Qi recipe, benefiting Yin recipe, harmonizing stomach recipe and detoxication and resolving masses recipe，with the same color, smell，taste, weight and package
15936054|NCT03372681|Procedure|Isoperistaltic Billroth II + Braun anastomosis|Laparoscopic distal gestrectomy will be applied with Isoperistaltic Billroth II + Braun reconstruction
15936055|NCT03372681|Procedure|Antiperistaltic Billroth II + Braun anastomosis|Laparoscopic distal gestrectomy will be applied with antiperistaltic Billroth II + Braun reconstruction
15936056|NCT03372668|Other|massage therapy combined with components of mirror therapy|"Individualized 20-minute, Swedish massage to address participant's unique phantom limb pain experience as if occurring on the corresponding, non-amputated limb. A specially designed apparatus is positioned such that a fixed, real-time image in place of the amputated limb is viewed by the participant during the massage session. The apparatus has a mirror, masking material to hide therapist and participant's lower body, electronic video display, electronic video camera, and equipment to electronically communicate the video signal to the video display. The mirror and video camera positioned to see a reflection of the existing limb being massage feds the image to a live video display situated in front of the participant to the correct orientation naturally represent the missing limb."
15936057|NCT03372642|Device|Subtalar endorthesis|Subtalar arthroereisis with endorthesis for pediatric flexible flat foot
15936058|NCT03372629|Drug|ID-085|Hard gelatin capsules for oral administration formulated in strengths of 10 mg, 100 mg, and 200 mg
15936059|NCT03372629|Drug|Placebo oral capsule|Placebo capsules matching ID-085 capsules
15936060|NCT03372616|Diagnostic Test|Invasive left ventricular diastolic function assessment|Left ventricular (LV) polyethylene catheter was inserted into left ventricular to directly measure LV filling pressure.
15936061|NCT03372616|Diagnostic Test|Invasive aortic blood pressure measurement|Aortic blood pressure will be measured with polyethylene catheter in aortic root.
15936062|NCT03372616|Diagnostic Test|Non-Invasive left ventricular diastolic function assessment|Echocardiography will be performed in all participants to assess left ventricular diastolic function non-invasively.
15936063|NCT03372616|Diagnostic Test|Non-Invasive aortic blood pressure measurement|Three devices (Sphygmocor [AtCor Medical, Australia], PulsePen [DiaTecne SRL, Italy], and Mobil-O-Graph [IEM, Germany] ) will be used to assess aortic blood pressure non-invasively when participants are undergoing invasive aortic blood pressure measurement.
15936064|NCT03372603|Drug|GSK2798745|GSK2798745 tablets will be available as white to almost white, round, film-coated tablets (micronized active pharmaceutical ingredient [API]) to be taken with a glass of water (approximately 240 mL).
15936065|NCT03372603|Drug|Placebo|Placebo tablets will be available as white to almost white, round, film-coated tablets to be taken with a glass of water (approximately 240 mL).
15936066|NCT03372590|Other|NICU-based rehabilitation bundle|Maternal-driven gestational age-appropriate intervention/activity bundle, including the evidence-based elements of vocal soothing, comforting touch, scent exchange, kangaroo care, and infant massage
15936067|NCT03372590|Other|Standard of care|Standard NICU care
15936068|NCT03372577|Behavioral|Mindfulness-Based Sex Therapy|It is based on an integration of psychoeducation, sex therapy, and mindfulness-based skills. the intervention will be delivered by a group of facilitators on a group based weekly.
15936069|NCT03372577|Other|Treatment as usual|Routine discharge counseling
15936070|NCT03372564|Procedure|Hip Capsule Repair|In the central compartment, significant and obvious pathologies will be addressed accordingly. Following addressing central compartment pathologies, cam impingement type lesions in the peripheral compartment will be treated. Once all pathologies are addressed, the interportal capsulotomy10 will be repaired by using simple interrupted sutures with absorbable suture (Number 1 Vicryl).
15936071|NCT03372551|Device|somofilcon A 1 day test lens|Contact lens
15936072|NCT03372551|Device|somofilcon A 1 day control lens|Contact lens
15936073|NCT03372538|Procedure|cesarean section or cesarean hysterectomy|upper segment cesarean section and or cesarean hysteroctomy
15936074|NCT03372525|Device|HFOV|Infants were randomized to HFOV
15936075|NCT03372525|Device|CMV|Infants were randomized to CMV
15936076|NCT03372512|Diagnostic Test|Bioimpedance spectroscopy|Fluid overload will be assessed by bioimpedance spectroscopy
15936077|NCT03372499|Dietary Supplement|diet management strategy for encephalopathy|diet management strategy for encephalopathy means diet management strategy from the nutritional management consensus of hepatic encephalopathy.
15936078|NCT03372486|Drug|Bupivacaine plus naloxone|Patients received 20 mL bupivacaine 0.5% plus 100 ng naloxone (1ml) in 2ml saline.(naloxone ampoule 0.4mg will dilute in 400ml of saline then 1ml of it will dilute in 10 ml saline, so each ml will have 100ng naloxone)
15936079|NCT03372486|Drug|Bupivacaine|Patients will be injected ultrasound guided in their brachial plexus by 20 mL bupivacaine 0.5% plus 3 ml of saline
15936080|NCT03372473|Drug|Montelukast mixed with Loratadine|Montelukast 5mg mixed with Loratadine 5mg, one dose per day
15936081|NCT03372473|Drug|Montelukast|Montelukast 5mg
15936082|NCT03372460|Device|Active stimulation|For active tDCS, the investigators will use a 1x1 configuration with the anode placed over EEG coordinate AF7 (using the 10-20 EEG convention) and the cathode over Fz. The investigators will use 3x3 cm sponge covered electrodes and a 2mA current for 25 minutes per session.
15936085|NCT03372447|Drug|Hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg|Single intramuscular dose of hydroxocobalamin 10,000mcg, Thiamin 100mg, Pyridoxine 50mg.
15936086|NCT03372434|Device|Investigational Intraocular Lens Device #1: Model ZFR00|IOL replaces the natural lens removed during cataract surgery.
15936087|NCT03372434|Device|Investigational Intraocular Lens Device #1: Model ZYR00|IOL replaces the natural lens removed during cataract surgery.
15936088|NCT03372434|Device|TECNIS Multifocal Intraocular Lens: Model ZLB00|IOL replaces the natural lens removed during cataract surgery.
15936089|NCT03372421|Other|Social Story|A short story written in the third person about what it's like to attend an assessment for ASD.
15936090|NCT03372421|Other|Standard Information|Information the host site currently sends out to patients informing them about what to expect from the assessment
15936091|NCT03372408|Other|Chart review|Retrospective chart review of program participation and socio-demographic & psychosocial characteristics
15936092|NCT03372395|Other|Lactobacillus rhamnosus BMX 54|Given once a day for 10 days, once every 3 days for 20 days and then once every 5 days for other 2 months in all patients (probiotics implementation for 3 months comprehensively).
15936093|NCT03372382|Drug|Ibuprofen|NSAID
15936094|NCT03372382|Drug|Acetaminophen|analgesic
15936095|NCT03372382|Drug|Norco|acetaminophen plus opioid
15936096|NCT03372369|Other|View CDC Poster|The poster designed by the CDC to explain contraceptive effectiveness.
15936097|NCT03372369|Other|View Patient-Centered Poster|The poster designed by the research team to explain contraceptive effectiveness. This poster was developed through cognitive interviews with 26 North Carolina women, and the final version of this poster was found to be more useful, acceptable, and attractive than the CDC poster by the majority of women participating.
15936098|NCT03372330|Drug|Standard care for sepsis and PAD|The standard medications care for the patient with PAD included antiplatelet agents.
15936099|NCT03372330|Drug|Standard care for sepsis|The standard care for the patient with sepsis.
15936100|NCT03372317|Drug|18F-MK-6240|Results of the 18F-MK-6240 PET scan will be correlated with other observations.
15936101|NCT03372304|Drug|Ropivacaine 0.2%|Perineural infusion of Ropivacaine 0.2% using a peripheral nerve block catheter and a portable infusion pump.
15936102|NCT03372291|Other|Usual Care|Usual leukemia care with all the supportive care measures instituted by the leukemia team
15936103|NCT03372291|Other|Psychological intervention|Psychological intervention is focused on educating patients about leukemia and how to cope with its treatment
15936104|NCT03372265|Drug|Ropivacaine 0.2%|Perineural infusion using a peripheral nerve block catheter and a portable infusion pump.
15936105|NCT03372252|Device|Electroencephalography|Simplified electroencephalography using three electroencephalogram electrodes and two electro-oculogram electrodes for the measurement of central respiratory control through the inspiratory premotor potentials.
15936106|NCT03372239|Drug|Indoximod base formulation|Specified dose on specified days
15936107|NCT03372239|Drug|Indoximod HCL (salt) formulation|Specified dose on specified days
15936108|NCT03372239|Other|Placebo|Specified dose on specified days
15936109|NCT03372226|Behavioral|Online self-help program|The program consists of 10 modules with many interactional exercises and homework-sheets. Themes that are addressed in the online-program are for example self-esteem, sleep hygiene, problem solving strategies, mindfulness-based relaxation and attention exercises as well as gambling-specific topics such as money/debt management and impulse control. In addition, the user learns to modify negative and gambling-specific thought distortions, to integrate positive activities into his/her daily routine, strategies to deal with the urge to play as well as ways to regulate debts and to prevent relapse.
15936110|NCT03372200|Drug|FYU-981|Oral daily dosing for 14 weeks
15936111|NCT03372200|Drug|Febuxostat|Oral daily dosing for 14 weeks
15936112|NCT03372187|Behavioral|DIET-MS|Following the completion of testing, all 20 participants will be placed into the DIET-MS group and will follow the prescribed diet plan for 12 weeks. At the end of the 12 weeks, the participants will return to complete follow up testing.
15936113|NCT03372174|Device|Maintaining mechanical ventilation during surgery|dead space ventilation using tidal volume of 2.5 mL/kg/pbw (predicted body weight) with 5-7 cm H2O Positive end-expiratory pressure
15936114|NCT03372174|Device|Absence of mechanical ventilation during surgery|absence of mechanical ventilation (and no Positive end-expiratory pressure) by disconnecting the tracheal tube from the ventilator
15936115|NCT03372161|Drug|SP-102|injection
15936116|NCT03372161|Drug|Placebo|injection
15936117|NCT03372148|Diagnostic Test|pHRMi|Pharyngeal High Resolution Manometry and Impedance swallowing function evaluation
15936118|NCT03372122|Drug|Chlorhexidine Gluconate|A cloth to cleanse and disinfect the skin
15936119|NCT03372122|Combination Product|HUBS with Hibiclens|A dry cloth to be used in combination with water and antimicrobial soap to cleanse and disinfect the skin
15936120|NCT03372109|Dietary Supplement|Meal replacement shake|Meal replacement shake taken two days per week during the modified fasting periods
15936121|NCT03372109|Dietary Supplement|Multivitamin and mineral capsules|Multivitamin/mineral supplement
15936122|NCT03372109|Dietary Supplement|Fish oil with sesame lignans and olive extract softgel|Wild Fish Oil Concentrate 2000mg, Olive Extract 300mg, Sesame seed lignan extract 10mg/2 softgels
15936123|NCT03372109|Dietary Supplement|Prebiotic Chewable tablet|Prebiotic Fiber 1,400 mg/tablet
15936124|NCT03372109|Dietary Supplement|Clove Extract and Maqui Berry extract capsule|Clove extract 250mg and maqui berry extract 200mg/capsule
15936125|NCT03372109|Dietary Supplement|.Whole Food Blend capsule|Whole food blend 1000mg/3 capsules
15936126|NCT03372109|Dietary Supplement|Turmeric extract capsule|Turmeric 25:1 extract 400mg/capsule
15936127|NCT03372109|Dietary Supplement|European White Kidney Bean capsule|White kidney bean extract 100mg/capsule
15936128|NCT03372109|Dietary Supplement|Saffron extract capsule|Saffron extract 88.25mg/capsule
15936129|NCT03372109|Dietary Supplement|Ubiquinol with Fulvic acid complex softgel|Ubiquinol 100mg and Fulvic Acid complex 100mg/softgel
15936130|NCT03372109|Dietary Supplement|Calcium with Hesperidin and gynostemma extract tablet|Calcium 130mg. hesperidin 500mg and gynostemma extract 450mg/ tablet
15936131|NCT03372109|Dietary Supplement|Multivitamin and mineral supplement|Multivitamin and multimineral supplement
15936132|NCT03372096|Device|Prostatic Artery Embolization|LC Bead LUMI is a spherical polyvinyl alcohol embolic particle that incorporates radiopaque moieties. Once a catheter has been fluoroscopically guided into the target vessel, the beads are then injected, causing obstruction at the arteriole level until the desired degree of embolization has occurred.
15936133|NCT03372083|Drug|Deferasirox|Deferosirox was provided in tablet forms of 90, 180 and 360mg. Tablets were crushed in the home environment and administered by sprinkling the full dose on to soft food to be consumed immediately.
15936134|NCT03372070|Device|cNEP|soft silicon collar applied to anterior neck with negative pressure
15936135|NCT03372057|Drug|Duvelisib|Duvelisib PO 25 mg BID or 50 mg BID or 75 mg BID in 28-day cycles.
15936136|NCT03372057|Drug|Duvelisib|Duvelisib PO 75 mg BID in 28-day cycles.
15936137|NCT03372057|Drug|Duvelisib|Duvelisib PO BID in 28-day cycles (dose determined in Optimization Phase)
15936138|NCT03372044|Drug|PF-06865571 Immediate release suspension|Suspension
15936139|NCT03372044|Drug|PF-06865571 Slow release MR tablets|Modified release tablets
15936140|NCT03372044|Drug|PF-06865571 Fast release MR tablets|Modified release tablets
15936141|NCT03372044|Drug|PF-06865571 Immediate release tablets|Immediate release tablets
15936142|NCT03372031|Behavioral|Piano training (Active)|Piano Curriculum. Participants were all trained on one of four 88-key pianos located in the assisted living facility. Piano instructors were 6 undergraduate Music Education and Music Performance majors. Each lesson of the week had a different focus: right and left hands separately, bimanually coupled, and bimanually uncoupled (Loehrer et al., 2016). Each week of the module had a different focus as well: notes played one step apart, notes played multiple steps apart (intervals), and tones played together (two-note chords) (van Vugt et al., 2016; Villeneuve et al., 2014). Each session began with skill exercises and ended with learning a simple, recognizable song. Two participants with extensive piano experience progressed to playing duets with the instructor and hymns out of a hymnal after mastery of the study curriculum. These training protocols were based on those of Schneider and colleagues' 2007 study.
15936143|NCT03372031|Behavioral|Piano Training (Passive)|Participants listened to their research partner complete 8 active piano training sessions across 2 weeks.
15936144|NCT03372018|Behavioral|Promotora-led Intervention (PLI)|Behavioral life-style program with cognitive-behavioral content lead by a team of trained community health workers (called promotoras) with the following principal goals - encouraging participants to lose 7% of their total weight and complete 150 minutes of moderate physical activity per week.
15936145|NCT03372018|Behavioral|Usual care (UC)|Participants in this arm will be given educational materials in spanish discussing mental health and diabetes prevention.
15936146|NCT03372005|Behavioral|Floorball|This intervention will have one week of testing before the first 12 weeks of floorball, followed by one week of testing before the last 27 week training period.
15936147|NCT03371992|Drug|Nivolumab|Nivolumab, pembrolizumab or atezolizumab will be administered as per the established standard of care for the eligible population.
15936148|NCT03371992|Diagnostic Test|3D-EX|Analysis of drug-mediated changes in the tumor microenvironment.
15936149|NCT03371992|Other|Evaluation of Response by RECIST|Evaluation of tumor response using the set of published rules to determine if a tumor has responded, is stable or progressed during treatments.
15936150|NCT03371979|Drug|Pegzilarginase|Administered IV
15936151|NCT03371979|Drug|Pembrolizumab|Administered IV
15936152|NCT03371966|Dietary Supplement|High Nitrate Beetroot Juice|High nitrate beetroot juice (120 ml) will be administered for 7 days consecutively followed by a 7 day washout period then 7 consecutive days of low nitrate beetroot juice.
15936153|NCT03371966|Dietary Supplement|Low Nitrate Beetroot Juice|Low nitrate beetroot juice (120 ml) will be administered for 7 days consecutively followed by a 7 day washout period then 7 consecutive days of high nitrate beetroot juice..
15936154|NCT03371953|Drug|Vecuronium|A top-up dose of vecuronium will be administered when the TOF count is 1 on the accelerometer. However, if there is a diaphragmatic contraction which interferes with surgical procedure then a dose will be given irrespective of the TOF count.
15936155|NCT03371953|Drug|Atracurium|A top-up dose of vecuronium will be administered when the TOF count is 1 on the accelerometer. However, if there is a diaphragmatic contraction which interferes with surgical procedure then a dose will be given irrespective of the TOF count.
15936156|NCT03371953|Drug|Vecuronium + Atracurium|A top-up dose of vecuronium + atracurium will be administered when the TOF count is 1 on the accelerometer. However, if there is a diaphragmatic contraction which interferes with surgical procedure then a dose will be given irrespective of the TOF count.
15936157|NCT03371940|Behavioral|Program ACTIVE Exercise|Please see the Exercise arm description above.
15936158|NCT03371940|Behavioral|Program ACTIVE CBT|Please see the Talk Therapy arm description above.
15936159|NCT03371940|Behavioral|Program ACTIVE|Please see the Talk Therapy + Exercise arm description above.
15936160|NCT03371940|Behavioral|Usual Care - No intervention|Please see the Usual Care arm description above.
15936161|NCT03371927|Other|SINC Feeding Protocol|Safe individualized nipple-feeding competence protocol for premature infants
15936162|NCT03371914|Behavioral|Management training and data feedback|The management training will consist of a variety of management topics, such as financial, workplace and staff management. The training will include a number of tools that the managers will be expected to bring back with them and use regularly at their site. There will be monthly refresher trainings for the managers via an online platform, where participants will interact about the topics covered in the training and others relevant to their work as managers. Participants will also receive monthly visualizations that compare the data that they enter via tablet monthly to both (1) their baseline data, and (2) to other sites' data. Outcomes that will be measured and reported back to sites include cost per client tested, number of condoms distributed, and number of FSW reached by educational interventions.
15936190|NCT03371693|Device|HIPEC|Patients consenting to this protocol will undergo their scheduled surgical procedure. After cytoreductive surgery (CRS) to a residual disease ≤ 2.5 mm, a single dose of lobaplatin (30 mg/m2) will be administered in normal saline via intraperitoneal hyperthermic perfusion using the closed-abdomen technique. HIPEC will be continued for 60 minutes in the hyperthermic phase (43℃±0.5℃). And HIPEC will be repeated at the 3 and 5 day after the day of CRS plus HIPEC.
15936191|NCT03371693|Device|CRS|cytoreductive surgery (CRS) to a residual disease ≤ 2.5 mm.
15936163|NCT03371901|Other|Physical therapy with BFR-LLST|"The criteria-based rehabilitation protocol for the patients with cartilage or meniscus repair may vary according to the surgical procedures.
~Patients will attend 5 individual treatments, and a 6-week supervised group-based rehabilitation program with BFR-LLST (Blood Flow Restriction - Low Load Strength Training) twice a week at the rehabilitation centre. Patient will be instructed to perform BFR-LLST 5 times a week in total (twice supervised, 3 times at home).
~During each BFR-LLST session, patients are encouraged to perform 4 sets of 30 repetitions, 15 repetitions, 15 repetitions, and 15 repetitions (or to fatigue in the final set), respectively.
~The exercise intervention will adhere to TIDieR (template for intervention description and replication)."
15936164|NCT03371888|Biological|Platelet-Rich Plasma intramuscular injections|A platelet-rich plasma intramuscular injections into the trigger points of painful muscles were performed.
15936165|NCT03371888|Biological|Placebo Comparator: 0,9% NaCl intramuscular injections|A 0,9% NaCl intramuscular injections into the trigger points of painful muscles were performed.
15936166|NCT03371875|Behavioral|Automated transition care reminders|The CHICA system will gather the elements of the TRAQ questionnaire and report the specific areas of deficiency to the physician. If a patient reaches the point of care transition (18 years), then an automated email is sent to a clinic nurse.
15936167|NCT03371862|Drug|Liraglutide Pen Injector [Victoza]|Pilot study of liraglutide in patients with short bowel.
15936168|NCT03371849|Drug|montelukast and levocetirizine FDC|HCP1102
15936169|NCT03371849|Drug|Singulair + xyzal|HGP0813 + HGP1408
15936170|NCT03371836|Drug|Clobazam|Clobazam is used as an adjunct medicine for all participants.
15936171|NCT03371823|Other|Normotensive|FMD is a measure of endothelial function by assessing the degree to which vessel dilates in response to increased flow. Pulse Wave Analysis and Pulse Wave Velocity assesses arterial stiffness and wave reflection in all women. Laser Doppler flowmetry is used in combination with cutaneous microdialysis as a minimally invasive technique to examine mechanisms of vascular function. ET-B and ET-A receptor antagonists will be perfused via intradermal microdialysis fibers while measuring cutaneous blood flow. ET-1 production and ET-B receptor expression in endothelial cells collected from an antecubital vein will also be assessed. Immunohistochemistry will be performed on skin punch biopsy samples to assess for protein expression of ET-A and ET-B receptors.
15936172|NCT03371823|Drug|Hypertensives|ANG II increases the synthesis of ET-1 and alters ET-A/B receptor expression, thus affecting ET-1 bioavailability. Losartan is an ANG II receptor antagonist which attenuates ET-1 production. Losartan 50 mg daily is administered for 14 days to hypertensive women. FMD is used to measure endothelial function. Pulse Wave Analysis and Pulse Wave Velocity assesses arterial stiffness and wave reflection. Laser Doppler flowmetry with cutaneous microdialysis is used to examine vascular function when ET-A and ET-B receptor antagonists is perfused via intradermal microdialysis fibers. ET-1 production and ET-B receptor expression in endothelial cells collected from an antecubital vein will be assessed. Skin punch biopsy samples will be used to assess for protein expression of ET-A and ET-B receptors.
15936173|NCT03371810|Behavioral|Bright light therapy|Mobile therapeutic light (10.000 LUX, white light without UV light), daily (except Sunday) for 30 min in the morning or evening for 10 weeks in total at home provided by a bright light therapy device (Philips EnergyLight HF 3419). Monitoring and feedback will be realized with the m-Health system comprising of a smartphone equipped with the m-Health App, and an activity sensor equipped with a light sensor to monitor the light exposure of the participant.
15936174|NCT03371810|Behavioral|Physical exercise|"During 10 weeks participants perform three days of aerobic activities proposed and in two of these days also do muscle-strengthening exercise. Specifically, a training day consists of: (i) a 5-min warm-up period, (ii) a 10-35 min of muscle-strength training on two of the three days, (iii) a 20-40 min of aerobic training, (iii), and a 5-min of flexibility/stretching cool-down. During the course of the 10 weeks, the duration and intensity of the exercises will increase gradually.
~Instruction, monitoring, and feedback will be realised by the m-Health system including a smartphone equipped with the m-Health app and Secure Digital Memory cards to store the exercise videos as well as an activity sensor equipped with a mobile sensor for the acquisition of physical activity."
15936175|NCT03371797|Drug|Valsartan, Amlodipine -|"Valsartan is a non-peptide, orally active, and specific angiotensin II receptor blocker acting on the AT1 receptor subtype used as an antihypertensive agent.
~Amlodipine besylate is a dihydropyridine long-acting calcium channel blocker."
15936176|NCT03371784|Drug|Hydrocortisone|I.V. administration
15936177|NCT03371784|Drug|Placebo|I.V. administration
15936178|NCT03371771|Behavioral|Volunteer-delivered Behavioral Activation|Behavioral Activation as delivered by trained volunteers
15936179|NCT03371771|Behavioral|MSW-delivered Behavioral Activation|Behavioral Activation as delivered by trained MSWs
15936180|NCT03371758|Other|skin biopsy|Punch skin biopsy will be taken from the lesional and non-lesional skin of vitiligo patients as well as healthy skin of controls.
15936181|NCT03371745|Procedure|Trophectoderm biopsy|Biopsy at blastocyst stage of trophectoderm cells for comprehensive evaluation of the eupolid status of the embryo.
15936182|NCT03371745|Procedure|Cryopreservation|Rapid freezing using vitrification
15936183|NCT03371745|Procedure|Embryo Transfer|Transfer of embryo that has been cultured in vitro into the uterus
15936184|NCT03371732|Behavioral|Motivational Intervention group|Participants in the intervention group a one-session brief motivational intervention administered by a psychologist. This intervention consist in a single adapted motivational interview lasting 20-30 minutes, based on the principles of the trans-theoretical model and on the manual for motivational therapy. It is carried out by the same psychologist, trained and supervised for this type of intervention.
15936185|NCT03371732|Behavioral|Educational advises group|Participants in this group benefit of brief educational advises (10 minutes interview maximum ; only on alcohol/tobacco consumption consequences on health), and received a pamphlet on the health effects of alcohol and tobacco consumption.
15936186|NCT03371719|Drug|Apalutamide|Given PO
15936187|NCT03371719|Radiation|External Beam Radiation Therapy|Undergo external beam radiation therapy
15936188|NCT03371719|Other|Placebo|Given PO
15936189|NCT03371706|Behavioral|Evidence-Based Treatment|Evidence-based speech language therapy treatment will be compared and contrasted in the two arms of the study.
15936192|NCT03371693|Device|IVCT|platinum-based intravenous chemotherapy
15936664|NCT03367923|Behavioral|Telephone-Based Intervention|Receive phone call
15936193|NCT03371680|Drug|Injection of 1-13 Carbon Leucine and deuterated water|All patients received a constant intravenous infusion of 1 g 1-13 Carbon Leucine (Cambridge Isotope Laboratories, Andover, MA) dissolved in saline for 24 h. Deuterated water (Cambridge Isotope Laboratories, Andover, MA) was administered as a 25 ml bolus at the study start and then, every 12 hours over the next 36 hours, as intermittent boluses corresponding to 0.0625% of fluid intake, to maintain steady state of deuterium enrichment in body water
15936196|NCT03371641|Behavioral|ASQ parental questionnaire|ASQ parental questionnaire
15936197|NCT03371641|Behavioral|Development scales|WPPSI - IV and NEPSY development scales
15936198|NCT03371641|Behavioral|Scale of Conners|Scale of Conners
15936199|NCT03371641|Behavioral|SCQ Questionnaire|SCQ questionnaire
15936200|NCT03371641|Procedure|Blood sample (mother)|Blood sample (mother) before delivery
15936201|NCT03371641|Procedure|Cord blood sample|Cord blood sample after delivery
15936202|NCT03371641|Procedure|Placenta sample|Placenta sample
15936203|NCT03371628|Device|Non invasive ventilation|Non invasive ventilation is a mode of mechanical ventilation that does not require the use of artificial airway.
15936204|NCT03371615|Other|Anti-regurgitation infant formula|Anti regurgitation infant formula
15936205|NCT03371602|Procedure|surgery|a diaphragmatic biopsy (100 microgram) and a parietal biopsy will be performed by the surgeon during surgery.
15936206|NCT03371602|Procedure|multi-organ sampling|a diaphragmatic biopsy (100 microgram) will be performed by the surgeon during surgery.
15936207|NCT03371589|Drug|Dexamethasone|Solution for otic injection
15936208|NCT03371576|Device|intraocular lenses|
15936209|NCT03371563|Drug|Antibiotics|Patients were treated with antibiotics for Lyme disease.
15936210|NCT03371563|Other|no intervention|controls were not given antibiotics
15936211|NCT03371550|Drug|Docetaxel|Induction chemotherapy
15936212|NCT03371550|Radiation|concomitant radiotherapy|Pulmonary and mediastinal radiotherapy
15936213|NCT03371550|Drug|Cisplatin|Induction chemotherapy
15936214|NCT03371537|Procedure|Liver debit measure|Mesure of liver debit during hepatectomy
15936215|NCT03371524|Other|Cardiac Echography|While routine cardiac echography is performed on patients with calcified aortic valve, a 30 second loop is recorded.
15936216|NCT03371498|Drug|Methylprednisolone|Ventilated patients presenting moderate to severe ARDS with a procollagen III alveolar level above 9 µg/L
15936217|NCT03371498|Drug|Methylprednisolone placebo|Ventilated patients presenting moderate to severe ARDS with a procollagen III alveolar level above 9 µg/L
15936218|NCT03371485|Biological|AST-VAC2|"Patients will receive up to a maximum of six vaccinations over six weeks. Each weekly AST-VAC2 vaccination will be administered as a split dose via two intradermal injections at a target dose defined as 1 × 107 viable cells. There is no dose escalation planned during this study; only one dose level will be explored.
~Each vial of AST-VAC2 will contain 0.6 mL. For each vaccination, vial contents should be drawn into one needle from the vial and delivered as two separate intradermal injections. Each injection will be a maximum of 0.3 mL each. The injections should be administered to the same body site approximately 1 cm apart.
~Patients should receive the intradermal injections in either the deltoid muscle on the arm, the outer thigh surface, anterior abdominal wall or buttock.
~Six vaccinations will be scheduled however may stop earlier if unacceptable toxicity develops."
15936219|NCT03371472|Device|Visualisation and measuring of paravalvular leak.|Visualisation and measurements of PVL by investigational sizing ballons made by Balton. The balloon is a modification of diameter and length of existing sizing ballons (AcuMark™, AMPLATZER™, Occlutech®).
15936220|NCT03371459|Drug|AS MDI|AS MDI 1+1+2+4+8 inhalations of 90 μg per inhalation
15936221|NCT03371459|Drug|Proventil|Proventil 1+1+2+4+8 inhalations of 90 μg per inhalation
15936222|NCT03371446|Genetic|oral epithelial cells obtained by rinsing with 3% sucrose|rinsing with 3% sucrose, for a single time of collection, patients received periodontal treatment after collection and data analysis.
15936223|NCT03371433|Other|Soft drinks|Caffeine and Caffeine free soft drinks
15936224|NCT03371420|Drug|PU-AD|
15936225|NCT03371420|Device|PET Scan|
15936226|NCT03371420|Other|Blood Draws|
15936227|NCT03371407|Other|Assessment of behavioral performance and the electrophysiological (EEG) activity in PD patients during the early and more advanced stages of the pathology|Assessment of behavioral performance and the electrophysiological (EEG) activity in PD patients during the early and more advanced stages of the pathology, using an instrumentation, called the Kinarm, which assess objectively sensory, motor and cognitive functions
15936228|NCT03371394|Other|no intervention|no intervention
15936229|NCT03371381|Biological|JNJ-64041757|Participants will receive intravenous (IV) infusions of JNJ-64041757 over approximately 60 minutes during each treatment cycle.
15936230|NCT03371381|Drug|Nivolumab|Participants will receive IV infusions of nivolumab over approximately 60 minutes during each treatment cycle.
15936231|NCT03371368|Procedure|Roux-en-Y Gastric Bypass (RYGBP)|This is a standard RYGBP procedure that would be performed clinically and is not research-specific.
15936232|NCT03371368|Procedure|Sleeve Gastrectomy (SG)|This is a standard SG procedure that would be performed clinically and is not research-specific.
15936233|NCT03371368|Behavioral|Very Low Calorie Diet (VLCD)|Weight loss with calorie restricted liquid diet. Subjects will be placed on a 800 kcal/day diet with a meal replacement (Optifast) provided by the investigator for 12 weeks. Then, transitioning to a higher calorie diet intake up to a year. Subjects will be closely monitored by study dietitian
15936234|NCT03371355|Drug|Placebo|Placebo (Matched with ISIS 703802)
15936235|NCT03371355|Drug|ISIS 703802 40 mg|ISIS 703802 40 mg, administered via SC injection, once every 4 weeks for 6 doses.
15936236|NCT03371355|Drug|ISIS 703802 80 mg|ISIS 703802 80 mg, administered via SC injection, once every 4 weeks for 6 doses.
15936237|NCT03371355|Drug|ISIS 703802 20 mg|ISIS 703802 20 mg, administered via SC injection, once every week for 26 doses.
15936238|NCT03371342|Drug|Meditoxin|Meditoxin (Botulinum toxin type A)
15936239|NCT03371342|Drug|Botox|Botox(Botulinum toxin type A)
15936240|NCT03371329|Biological|MSC|bone marrow derived cultured MSC (mesenchymal stem cell)
15936241|NCT03371316|Biological|ViaShield|Anti-adhesion scores using amnion patch
15936242|NCT03371303|Other|collection of prescription data|collection of prescription data before and after a hospitalization
15936243|NCT03371290|Other|Mirror Therapy|The healthy UE will be positioned in front of the mirror and the paretic UE behind it, enabling the patient to observe the movements of the healthy limb through the mirror, interpreting that image as the affected limb. The MT protocol will be composed of active bimanual exercises of range of motion and functional exercises. Three sets of 15 repetitions will be performed for each exercise with a 20 seconds interval between each series, for 30 minutes. The exercises: 1) Elbow flexion/extension; 2) Wrist flexion/extension in neutral position; 3) Fingers flexion/extension in neutral position; 4) Forearm pronation/supination; 5) Roll the ball with hands; 6) Squeezing the sponge; 7) Drag a towel in anteroposterior direction; 8) Opponency of fingers; 9) Climb the mirror with the fingers (similar to walking the spider).
15936244|NCT03371290|Other|Control Intervention|"In the control intervention, patients will be performed the same bimanual activities proposed by the MT protocol, but without the reflector side of the mirror. The mirror will be placed in the same position as the MT intervention. However, the subject will have access to the non-reflective side of the mirror, directly visualizing the movement of his healthy arm.
~Both interventions will be performed a single session of MT or control composed of 30 minutes of exercises. The participants who will be first assigned to the MT intervention, after 4-weeks washout period, will be performed the same procedures, but in the control intervention. Likewise, patients who will be first allocated to control intervention, after 4-weeks of washout, will be performed the same procedures, however in MT intervention."
15936245|NCT03371277|Other|Medical visit for specific questionnaires|Ambiguous Intentions Hostility Questionnaire (AIHQ) developed by Combs (2007)
15936246|NCT03371251|Drug|BOS161721|SC administration
15936247|NCT03371251|Drug|Placebo|SC administration
15936248|NCT03371238|Behavioral|Floorball|The subjects in this group are set to play floorball three times pr. week for 39 weeks.
15936249|NCT03371225|Device|Active tDCS|Active tDCS: A 1x1 Low-intensity DC Stimulator will be used to deliver direct current through rubber electrodes in saline soaked sponges. The anode will be placed over the left primary motor cortex (M1) while the cathode will be placed over the contralateral supra-orbital area. 20 minutes of tDCS will be applied.
15936250|NCT03371225|Procedure|Active Exercise|Participants will walk briskly in a treadmill (as to keep at 60-70% maximum heart rate) for 30 minutes
15936251|NCT03371225|Device|Sham tDCS|Active tDCS: A 1x1 Low-intensity DC Stimulator will be used to deliver direct current through rubber electrodes in saline soaked sponges. The anode will be placed over the left primary motor cortex (M1) while the cathode will be placed over the contralateral supra-orbital area. Only 30 seconds of current will be applied for the sham condition.
15936252|NCT03371225|Procedure|Sham Exercise|Participants will walk in a treadmill (as to keep at 5% within their baseline heart rate) for 30 minutes.
15936253|NCT03371212|Device|Dual mobility cohort|Patients will receive the Taperloc femoral stem, ceramic femoral head (size 32mm for acetabular components 48/50mm; size 36mm for acetabular components > 52mm), polyethylene bearing, and G7 acetabular shell.
15936254|NCT03371212|Device|Conventional cohort|Patients will receive a Taperloc femoral stem, ceramic femoral head (size 32mm for acetabular components 48/50mm; size 36mm for acetabular components > 52mm), polyethylene bearing, and G7 acetabular shell
15936255|NCT03371199|Drug|Sodium chloride|Sodium chloride tablets, 250 mg
15936256|NCT03371199|Drug|Placebo Oral Tablet|Starch tablets
15936257|NCT03371186|Other|Community Health Worker|The intervention is designed to address these primary drivers of underutilization of reproductive, maternal, newborn, and child health services in rural Nepal, namely: poverty, lack of social support, and poor birth planning. The investigators have worked with a cadre of Community Healthcare Workers who, in addition to the responsibilities of local community health volunteers, have added responsibilities, training, and managerial support. These women support their community members in their homes to identify and overcome social barriers and plan for emergency healthcare needs. The goals are to increase utilization of services, maternal and neonatal health knowledge, self-efficacy, social support, and emergency planning among mothers
15936258|NCT03371186|Other|Continuous Surveillance|Each patient identified by a Community Health Worker will undergo a complete diagnostic evaluation by the hospital-based clinicians and will be enrolled in the study only if they are identified as currently pregnant, have recently given birth, or have a child under the age of 24 months. Continuous surveillance systems ensure that the entire population is surveyed every three months and has a three month touchpoint with a Community Health Worker.
15936259|NCT03371186|Other|CB-Integrated Management of Newborn and Childhood Illness|Safe delivery care; effective neonatal resuscitation; management of childhood diarrhea, malnutrition, and pneumonia; and treatment of traumatic and congenital surgical conditions can reduce child mortality. Community Based Integrated Management of Newborn and Child Illness (CB-IMNCI) has shown substantial reductions in neonatal and early child mortality. Community Health Workers will use CB-IMNCI as the clinical protocol for ongoing care to the community.
15936338|NCT03370536|Procedure|AF ablation|Empiric ablation (CFAE or linear ablation) is not permitted
15936339|NCT03370536|Drug|Ibutilide|Progressive doses of Ibutilide administered (0.25mg, then 0.25mg, then 0.5mg)
15936260|NCT03371186|Other|Group Antenatal and Postnatal Care|The proposed model will change antenatal and pediatric care in three major ways: 1) conduct care in a group setting, 2) provide expert and facilitated peer counseling, and 3) incorporate emergency planning. The group setting is designed to create a supportive social network among women facing similar challenges. The opportunity for counseling beyond the current standard will promote detailed emergency planning and the sharing of context-specific advice from peers to overcome barriers to access care. This intervention draws on the strength within communities of women to change health-seeking behaviors.
15936261|NCT03371186|Other|Balanced Post-Partum Contraceptive Counseling|Research on interventions to improve postpartum contraception suggest strategies that bridge the continuum of reproductive health care-antenatal care, labor and delivery, postnatal care, and infant care-are more effective than short term, stand-alone counseling sessions. The structured counseling module incorporated in the intervention will be partially adapted from the Balanced Counseling Strategy, an interactive contraceptive counseling method developed by the Population Council in accordance with the World Health Organization's tiered effectiveness guidelines. Prior studies in clinical settings in Nepal have demonstrated increased uptake of modern contraceptive methods, especially of long-acting reversible contraceptives with use of balanced counseling.
15936262|NCT03371173|Drug|Ferric maltol 30 mg (Feraccru®)|Feraccru® 30 mg hard capsules will be used. Each capsule contains 30 mg iron (as ferric maltol), 91.5 mg of lactose, 0.5 mg of Allura Red AC (E129) and 0.3 mg Sunset Yellow FCF (E110) as excipients with known effects
15936263|NCT03371147|Other|CancerLife|CancerLife is a patient facing messaging app that gives cancer survivors and caregivers the ability to update family and friends of their health status through their existing social networks and at the same collect psychosocial and symptom reports that can be shared with the patients care team.
15936264|NCT03371134|Biological|Harvesting of muscular biopsies|Muscular biopsies will be harvested during surgery; them satellite cells will be isolated and characterized in vitro.
15936265|NCT03371121|Other|AT-AMIC (arthroscopic talus autologous matrix induced chondrogenesis)|to fill arthroscopically osteochondral talar lesion
15936266|NCT03371108|Biological|Gan & Lee Insulin Glargine Injection|Route of administration: subcutaneous injection
15936267|NCT03371108|Biological|Lantus®|Route of administration: subcutaneous injection
15936268|NCT03371095|Drug|Infliximab|Use of infliximab instead of cyclophosphamide
15936269|NCT03371095|Drug|Cyclophosphamide|Use of cyclophosphamide
15936270|NCT03371082|Biological|Gan & Lee Insulin Glargine Injection|Route of administration: subcutaneous injection
15936271|NCT03371082|Biological|Lantus®|Route of administration: subcutaneous injection
15936272|NCT03371069|Other|users of methylphenidate|Children and adolescents who are users of methylphenidate, 2010 to 2015
15936273|NCT03371056|Biological|Bacteriological analyses on clinical samples performed with swabs|Bacteriological analyses will be performed to assess the InSPIRe kit
15936274|NCT03371043|Other|users of analgesic medications|Children and adolescents who are users of analgesic medications, 2012 to 2015
15936276|NCT03371017|Drug|Atezolizumab|"Atezolizumab will be administered, 1200 mg by IV infusion with :
~gemcitabine 1000 mg/m2, followed by carboplatin target area under the curve (AUC) 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle or with capecitabine 1000 mg/m2, twice daily orally on Days 1 to 14, followed by a 7-day rest period in each 3-week treatment cycle"
15936277|NCT03371017|Drug|Placebo|"Placebo will be administered, 1200 mg by IV infusion with :
~gemcitabine 1000 mg/m2, followed by carboplatin target area under the curve (AUC) 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle or with capecitabine 1000 mg/m2, twice daily orally on Days 1 to 14, followed by a 7-day rest period in each 3-week treatment cycle"
15936278|NCT03371017|Drug|Gemcitabine|Gemcitabine 1000 mg/m2, followed by carboplatin target area under the curve (AUC) 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle
15936279|NCT03371017|Drug|Capecitabine|Capecitabine 1000 mg/m2, twice daily orally on Days 1 to 14, followed by a 7-day rest period in each 3-week treatment cycle
15936280|NCT03371017|Drug|Carboplatin|Carboplatin target area under the curve (AUC) 2 mg/ml/min, both administered by IV infusion on Days 1 and 8 of each 3-week treatment cycle
15936281|NCT03371004|Drug|4-Demethyl-4-cholesteryloxycarbonylpenclomedine|IV administration as described
15936282|NCT03370991|Dietary Supplement|Blueberry Powder|22 g/day freeze-dried blueberry powder for 12 weeks
15936283|NCT03370991|Dietary Supplement|Placebo Powder|22 g/day placebo powder for 12 weeks
15936284|NCT03370978|Behavioral|Text Messaging|"To communicate with intervention patients after discharge from the ED, we will use a bidirectional text messaging service provided by another physician's research group within the University of Iowa. The nurse navigator will enter the patient's study identification number, first and last name and cell phone onto a secure study website established by this research group.
~Patients will, as previously mentioned, have had their cell phone number tested in the text messaging system prior to leaving the Emergency Department (this includes the control group).
~Patient's will receive a text message 3 days, and 1 day, prior to their scheduled follow-up appointment with Family Medicine (this appointment having been scheduled through the Emergency Department Nurse Navigators). Each text message will remind the patient of the date/time of their appointment, and provide them a link containing a map with the location of their appointment."
15936285|NCT03370965|Diagnostic Test|Neuro-ophtalmology examination|"Patients will first undergo a full neuro-ophthalmic examination which includes visual acuity, contrast vision, color vision, slit-lamp anterior segment and fundus examination as well as automatized visual field and optical coherence tomography of the optic nerves and retina.
~Patients will then be admitted to the Neurology and Ophthalmologic Department for optic neuritis emergency treatment, 3-Tesla brain and medullar MRIs, and ancillary testing. Specific NMO antibodies (AQP-4 and MOG) will be tested in all patients. Neuro-ophthalmic examination will be repeated after 3 days of IV steroids in order to decide on further treatment."
15936286|NCT03370952|Procedure|laproscopy|laparoscopic ovarian cystectomy
15936340|NCT03370523|Other|No intervention is planned in our study|No intervention is planned in our study
15936341|NCT03370510|Drug|Oxytocin|Oxytocin nasal spray.
15972484|NCT03094052|Biological|Trastuzumab|Given Intravenously (IV)
15936287|NCT03370952|Procedure|combined laproscopic and minilaparotomy ovarian cystectomy|"Under general anaesthesia, the patient is placed in the modified dorsal lithotomy position a 10-mm umbilical trocar is inserted. A panoramic view of the pelvis was obtained together with full assessment of the ovarian mass(es).
~Aspiration of the cyst:Delivery of affected ovary outside the abdominal cavity:
~Ovarian cystectomy:
~Re-introduction of the ovary to inside the abdominal cavity:"
15936288|NCT03370913|Biological|valoctocogene roxaparvovec|Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Hemophilia A
15936289|NCT03370900|Other|Testing|Participants either received 20 case testing with or without feedback
15936290|NCT03370887|Drug|AZD8601|AZD8601 solution for injection, 0,5 mg/mL and 5 mg/mL will be given as 30 injections of 0.1 mg (3 mg per patient), or 1 mg (30 mg per patient) respectively on a single occasion
15936291|NCT03370887|Drug|Placebo|Placebo for AZ8601 injection for solution will be given as 30 injections per patient on a single occasion
15936292|NCT03370874|Biological|ALLO-ASC-DFU|Application of ALLO-ASC-DFU sheet to diabetic foot ulcer
15936293|NCT03370874|Procedure|Vehicle sheet|Application of Vehicle sheet to diabetic foot ulcer
15936294|NCT03370861|Biological|Immunotherapy|Medications that increase the activity of the immune system.
15936295|NCT03370848|Dietary Supplement|Psyllium|Aspirin 325 mg tablet and two 1.7gm psyllium wafers (3.4gm total) 30 minutes prior to niacin ER
15936296|NCT03370848|Drug|Aspirin|Aspirin 325 mg tablet 30 minutes prior to niacin ER
15936297|NCT03370835|Drug|Metoprolol succinate ER|Cardioselective beta-blocker
15936298|NCT03370835|Drug|Carvedilol|Non-cardioselective beta-blocker
15936299|NCT03370822|Device|MONICA AN24 device|Application of MONICA AN24 device and recording for the longest period of fetal heart rate recording possible (limited by battery life)
15936300|NCT03370809|Radiation|Brain PET/CT step|a cerebral PET/CT will be registered on the 45th minute after 18F-FDG injection and just before the whole body recording. This recording does'nt need a new injection but needs a low dose scanner
15936301|NCT03370796|Other|Reminiscence Therapy Program|The Reminiscence Therapy program is composed of: (i) main strand lasting 7 weeks, with sessions twice a week (total of 14 sessions); (ii) maintenance strand, which runs for 7 weeks, once a week (total of 7 sessions). The duration for each session will be 60 minutes.
15936302|NCT03370783|Drug|Ethanol|Moderate alcohol consumption
15936303|NCT03370770|Drug|Afatinib|GILOTRIF, GIOTRIF, XOVOLTIB
15936304|NCT03370770|Drug|Osimertinib|on T790M resistance mutation was developed
15936305|NCT03370757|Other|3-hour bundled care|Infants in the 3-hour bundled care group will receive diaper changes every 3 hours with observational coding, microbiome samples, skin pH measurements and trans epidermal water loss measurements taken 3 times per week.
15936306|NCT03370757|Other|6-hour bundled care|Infants in the 6-hour bundled care group will receive diaper changes every 6 hours with observational coding, microbiome samples, skin pH measurements and trans epidermal water loss measurements taken 4 times per week.
15936307|NCT03370744|Diagnostic Test|Neuropsychological scale|Neuropsychological scale, including mini-mental state examination (MMSE), Montreal cognitive assessment (MoCA), clinical dementia rating scales (CDR) and so on
15936308|NCT03370731|Procedure|adenotonsillectomy|Resection of adenoidal tissue or hypertrophy tonsils by radiofrequency ablation or other methods.
15936309|NCT03370731|Other|Nonsurgical management|Nasal Irrigation or inhaled corticosteroids, etc.
15936310|NCT03370718|Drug|Cabozantinib|Given PO
15936311|NCT03370718|Other|Pharmacogenomic Study|Correlative studies
15936312|NCT03370718|Other|Pharmacokinetic Study|Correlative studies
15936313|NCT03370705|Drug|Sulodexide|Sulodexide 250 ULS twice daily per oral route
15936314|NCT03370705|Drug|Statin|Statin 20mg once daily per oral route,
15936315|NCT03370705|Drug|Antiplatelet Agents|Antiplatelet therapy 75mg once daily per oral route
15936316|NCT03370705|Drug|ACE inhibitor|ACE inhibitor 20mg once daily per oral route
15936317|NCT03370692|Other|Cognitive assesment, Frailty assessment|Asking relatives (using a structured questionaire) about cognitive function at admission , likewise about frailty using the Clinical Frailty Score
15936318|NCT03370666|Other|HFNT|High flow nasal therapy
15936319|NCT03370666|Other|NIV|Noninvasive ventilation
15936320|NCT03370653|Drug|Odiparcil|Investigational product: odiparcil 250 mg tablets
15936321|NCT03370653|Other|Placebo|Comparator: placebo tablets similar to odiparcil 250 mg tablets
15936322|NCT03370640|Drug|SEP-363856|An oral 25 or 50mg dose of SEP 363856
15936323|NCT03370627|Biological|Monoclonal anti-cd303 antibody|Addition of monoclonal anti CD303 antibodies or not (control) on 2 blood samples of the same patient, to which 10 μl of CpG (20 μg / ml) are added in order to activate plasmacytoid Dendritic Cells and to induce the secretion of Type I interferons.
15936324|NCT03370614|Other|IBS Group|Participants will receive approximately 2 months of dietary and nutritional counseling.
15936325|NCT03370614|Other|Healthy Control Group|Participants will not receive any dietary or nutritional counseling.
15936326|NCT03370601|Drug|Infliximab|Infliximab 10mg/kg every 8 weeks
15936327|NCT03370601|Drug|Mercaptopurine|6-mercaptopurine 1 à 1,5 mg/kg
15936328|NCT03370601|Drug|Azathioprine|Azathioprine 2 à 2.5mg/kg/j
15936329|NCT03370601|Drug|Infliximab|Infliximab 5mg/kg every 8 weeks
15936330|NCT03370588|Drug|dexmedetomidine|Group A: dexmedetomidine infusion (0.4㎍/kg/hr) from anesthetic induction until the start of closure of peritoneum. Group B: Saline infusion during same time period.
15936331|NCT03370588|Drug|Normal saline|Group B: Saline infusion during same time period.
15936332|NCT03370575|Drug|ethiodized poppyseed oil|Hysterosalpingography using ethiodized poppyseed oil
15936333|NCT03370575|Drug|the second-generation non-ionic monomer contrast|Hysterosalpingography using the second-generation non-ionic monomer contrast
15936334|NCT03370562|Drug|Dexmedetomidine|Administration of 10 mcg intravenous dexmedetomidine
15936335|NCT03370562|Drug|Placebo|Administration of normal saline
15936336|NCT03370549|Behavioral|AWARE intervention|Group psychotherapy for Asian-American women
15936337|NCT03370536|Device|CardioInsight ECGI Mapping System|The CardioInsight mapping system is a noninvasive, single beat cardiac arrhythmia mapping system that provides 3D electroanatomic maps of the heart.
15936342|NCT03370510|Behavioral|Pivotal Response Treatment|An evidence-based manualized treatment for individuals with autism, which was specifically designed to improve social communication.
15936343|NCT03370510|Drug|Placebo|Placebo nasal spray.
15936344|NCT03370497|Dietary Supplement|Milk Mineral Supplement|Milk Minerals containing 1000 mg calcium
15936345|NCT03370497|Dietary Supplement|Whey Protein Hydrolysate|50 g whey protein hydrolysate
15936346|NCT03370484|Dietary Supplement|Control|Water with 80 mg sucralose
15936347|NCT03370484|Dietary Supplement|Milk mineral supplement|Water with milk mineral supplement (1000 mg calcium), plus 80 mg sucralose
15936348|NCT03370471|Behavioral|Retrieval Practice + Moderate Intensity Exercise|Subjects will engage in 30 minutes of moderate-intensity cycling prior to word learning using Retrieval Practice (active retrieval during learning)
15936349|NCT03370471|Behavioral|Retrieval Practice + Gentle Stretching|Subject will engage in 30 minutes of gentle upper- and lower- limb stretching prior to word learning using Retrieval Practice (active retrieval during learning)
15936350|NCT03370471|Behavioral|Study Only + Moderate Intensity Exercise|Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
15936351|NCT03370471|Behavioral|Study Only + Gentle Stretching|Subjects will engage in 30 minutes of gentle stretching prior to word learning using Study Only (no active retrieval during learning)
15936352|NCT03370458|Dietary Supplement|Lactobacillus plantarum DR7|This project aims to study the benefits of probiotics namely Lactobacillus plantarum DR7 for brain health benefits primarily to alleviate stress, among adults in Malaysia aged from 18-60 years. Secondary emphases include respiratory and gastrointestinal health
15936353|NCT03370458|Dietary Supplement|Placebo|This project aims to study the benefits of probiotics namely Lactobacillus plantarum DR7 for brain health benefits primarily to alleviate stress, among adults in Malaysia aged from 18-60 years. Secondary emphases include respiratory and gastrointestinal health
15936354|NCT03370432|Other|Observational|Information on diet, lifestyle, weight, height, medical treatment, environmental exposures, and other socio-economic factors were collected at enrolment using questionnaires and interviews
15936355|NCT03370419|Behavioral|Treatment|Lifestyle intervention fostering the development of behavioral automaticity (habit strength) or dietary and physical activity behaviors.
15936356|NCT03370419|Behavioral|Usual care|Usual care
15936357|NCT03370406|Drug|5-fluorouracil|Intralesional injections of 50mg/ml over a 3 week period.
15936358|NCT03370406|Drug|Imiquimod 5% cream|Topical application of 5% cream over a 3 week period.
15936359|NCT03370393|Behavioral|Pathways for African-Americans' Success (PAAS)|PAAS is a 6-week, technology-delivered, family-based youth risk intervention program. PAAS includes 6 sessions for parents and youth, and joint sessions in which they both engage on the same computer to integrate and practice the skills they have just learned in their separate sessions. Each session includes a review, a virtual discussion, and observing and interacting with four parent and four youth Avatars that reflect phenotypes of African Americans (AA), with voice-overs by AA parents and youth. Videos portraying family interactions and intrapersonal processes are integrated into each session to convey key points of the intervention along with interactive activities to promote skill-building and to reinforce learning. PAAS also includes a technology tutorial and an introductory session.
15936360|NCT03370380|Drug|Aflibercept|Patients are treated according to authorization of Aflibercept
15936361|NCT03370367|Drug|13-cis retinoic acid|Taken daily.
15936362|NCT03370367|Other|Placebo|Placebo
15936363|NCT03370354|Behavioral|Observational|Ask patients about sleep quality and identify reasons of troubled sleeping patterns in the units.
15936364|NCT03370341|Device|active anodal tDCS|active anodal tDCS with behavioral tasks to assess IA
15936365|NCT03370341|Device|sham tDCS|sham tDCS with behavioral tasks to assess IA
15936366|NCT03370328|Other|Peppermint oil|The study product is a commercial essential oil product and nasal inhaler. It is to be prepared by a trained, independent individual who will add 4 drops of one of the three oils/oil combinations. The subject will be instructed to twist off the cap and position inhaler in such a way as to allow the subject to inhale the vapors; it can be reused for multiple administrations. Essential oils have been the subject of other studies in treating nausea. If nausea is unrelieved, treatment will progress to the ordered antiemetic.
15936367|NCT03370328|Other|Ginger oil|The study product is a commercial essential oil product and nasal inhaler. It is to be prepared by a trained, independent individual who will add 4 drops of one of the three oils/oil combinations. The subject will be instructed to twist off the cap and position inhaler in such a way as to allow the subject to inhale the vapors; it can be reused for multiple administrations. Essential oils have been the subject of other studies in treating nausea. If nausea is unrelieved, treatment will progress to the ordered antiemetic.
15936368|NCT03370315|Other|Dance Program|The dance program consists of dance classes inspired by the rhythm of Forró and Samba. The sessions are divided into four stages: 1) stretching and sensitization of the body, with the support of chairs; 2) balance and rhythm exercises, with the support of the bar; 3) dance inspired by the genres worked - Forró and Samba; 4) Fun activities that stimulate socialization or with visual clues, working displacements, motor coordination, rhythm, improvisation and creativity. 24 sessions, twice a week, which session take 60 min.
15936369|NCT03370315|Other|Walking Program|The walking program consists of 3 moments: 1) a brief warm-up of free walking for 3 minutes in the comfortable velocity; 2) then walking according to the training cycle, the intensity will be between 60 and 80% of the reserve heart rate; 3) a relaxation. 24 sessions, twice a week, which session take 60 min.
15936370|NCT03370302|Drug|TAK-228|TAK-228 Capsules.
15936371|NCT03370289|Biological|BLB-750 Vaccine (Qinghai RG strain)|BLB-750 Injection
15936372|NCT03370276|Drug|Nivolumab|Nivolumab intravenously (IV) at 240 mg as outlined in the treatment arms.
15936373|NCT03370276|Drug|Cetuximab|Cetuximab intravenously (IV) at 500 mg/m^2 or 250 mg/m^2 as outlined in the treatment arms.
15936374|NCT03370263|Drug|Benlysta|Benlysta will be administered intravenously or subcutaneously.
15936375|NCT03370224|Behavioral|Memory retraining exercises|Memory retraining exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).
15936376|NCT03370224|Behavioral|Placebo control memory exercises|Placebo control memory exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).
15936377|NCT03370211|Other|resistance training|Participants from TG performed program, executed in 3 sets of 10-15RM, 3 times per week on Mondays, Wednesdays, and Fridays. The RT program was composed of 8 exercises comprising one exercise with free weights and seven with machines performed in the following order: chest press, horizontal leg press, seated row, knee extension, preacher curl (free weights), leg curl, triceps pushdown, and seated calf raise. All participants were personally supervised by physical education professionals with substantial RT experience to help ensure consistent and safe exercise performance. Participants were instructed to inhale during the eccentric phase and exhale during the concentric phase while maintaining a constant velocity of movement at a ratio of approximately 1:2 seconds (concentric and eccentric phases, respectively). Participants were afforded 1 to 2 min of rest between sets and 2 to 3 min between each exercise. The average duration of each session lasted approximately 50-60 minutes.
15936378|NCT03370198|Biological|NKR-2 cells|NKR-2 cells will be administered (hepatic transarterial administration) every 2 weeks (14 days) for a total of 3 administrations within 4 weeks (28 days)
15936379|NCT03370185|Drug|Duvelisib|Duvelisib 25 mg orally (PO) twice daily (BID) continuously in 28-day cycles
15936380|NCT03370172|Drug|BAX 888|Participants will receive a single peripheral IV infusion of BAX 888 in Cohort 1, 2, 3 on Day 0.
15936381|NCT03370159|Drug|6,8-Bis(benzylthio)octanoic Acid|Given IV
15936382|NCT03370159|Drug|Docetaxel|Given IV
15936383|NCT03370159|Other|Pharmacological Study|Correlative studies
15936384|NCT03370146|Behavioral|Mental training based on Motor Imagery|Patients of the experimental group will be instructed to imagine walking, from a first person perspective, focusing on the kinaesthetic sensations typically associated with the movement. The motor imagery training will be performed using the support of a laptop, on which there will be presented complex static scenes, representing different kind of paths with different landmarks to reach during the mental walking.
15936385|NCT03370146|Behavioral|Cognitive training|Patients of the control group 1 will undergo a general cognitive training, not based on motor imagery.
15936386|NCT03370146|Behavioral|Evaluation of gait abilities|All the subjects included in the trial will undergo a series of behavioral test for the evaluation of gai abilities
15936387|NCT03370133|Drug|Bimekizumab|Bimekizumab will be provided at pre-specified time intervals.
15936388|NCT03370133|Drug|Ustekinumab|Ustekinumab will be provided as dose 1 for subjects weighing <=100 kg and as dose 2 for subjects weighing >100 kg at pre-specified time intervals.
15936389|NCT03370133|Other|Placebo|Subjects will receive Placebo at pre-specified time points.
15936390|NCT03370120|Drug|Padsevonil|"Pharmaceutical Form: film-coated tablet
~Route of Administration: Oral use"
15936391|NCT03370107|Device|rTMS|Conventional magnetic stimulations will be applied with a MacPROX100 machine using neuronavigation system. H-coil rTMS will be delivered with the Brainsway H-coil (Brainsway, Jerusalem, Israel) applied via a helmet placed on the head corresponding to the primary motor cortex (H10 coil) and connected to a Masgtim Rapid2 stimulatior (Mastim, Whitland, UK), while sham stimulation will be delivered with a sham coil placed in the helmet encasing the active rTMS coil. Active rTMS sessions with H-coil will use exactly the same parameters of stimulation as conventional rTMS.
15936392|NCT03370094|Diagnostic Test|Audio-video-streaming of suspected stroke symptoms and signs|The diagnosis based on the patient evaluation by end-to-end encrypted real-time video will be compared to the gold standard, consisting of an in-person neurological examination by a stroke specialist in patients with suspected acute stroke.
15936393|NCT03370081|Device|CAPNOGRAPHY|MONITORING OF CAPNOMETRY USING ETCO2 METHOD
15936394|NCT03370068|Other|ICSI|Oocytes retrieved from one ovary will undergo insemination by ICSI.
15936395|NCT03370068|Other|Conventional IVF|Oocytes retrieved from the second ovary will undergo insemination by conventional IVF
15936396|NCT03370055|Device|LeucoPatch®|LeucoPatch® is an elastic membrane produced by the patients own venous blood by centrifugation, and one or two is placed on the wound once a week The LeucoPatch® consist of the fibrin Leucocytes and growth factors from the patients own blood
15936397|NCT03370055|Other|Control,|Usual wound care in a specialized clinic
15936398|NCT03370042|Procedure|semilunar coronally positioned flap with free gingival graft|
15936399|NCT03370042|Procedure|semilunar coronally positioned flap alone|
15936400|NCT03370016|Procedure|Amount of Pneumoperitoneum Pressure applied during RARP|Patients will be randomly assigned to undergo RARP either at a pneumoperitoneum pressure of 8 mmHg (experimental) or 12mm Hg (standard technique)
15936401|NCT03370003|Other|Standard medical care|All children will receive nutritional treatment and standard medical care in accordance with the nutritional guidelines of the national protocol, with the exception of the routine distribution of antibiotics.
15936402|NCT03369990|Drug|Botulinum toxin type A|Botulinum toxin type A(DWP450)
15936403|NCT03369990|Drug|Placebos|Normal Saline
15936404|NCT03369977|Device|BioGlue Surgical Adhesive|BioGlue (produced by CryoLife in Kennesaw, GA) is a surgical adhesive with two components respectively purified bovine serum albumin (BSA) and Glutaraldehyde (their proportions are 4:1). Crosslinked bonds (covalent bonds) of Glutaraldehyde cross-link the protein on the surface of the tissue and the amino residue of the bovine serum albumin. BioGlue also adheres to the synthetic matrix material by a mechanical interlocking mechanism in the space of graft matrix.
15936405|NCT03369977|Other|Traditional Surgical Repair|Traditional surgical repair as determined by the surgeon
15936406|NCT03369964|Drug|Atezolizumab|"In Cohort A1, Atezolizumab will be administered, 1200 mg IV, every 3 weeks starting on Cycle 2; Day 1 of a 21 day cycle
~In Cohort A2, Atezolizumab will be administered, 1200 mg IV, starting on Cycle 2; Day 1 of a 21 day cycle
~In Cohort A2 , In Cycle 2-8, Atezolizumab will be administered, 1200 mg IV on day 1 of each 21 day cycle
~In Cohort A2, Atezolizumab will be administered, 1200 mg IV starting on Cycle 9; Day 1 of each 21 day cycle"
15936407|NCT03369964|Drug|Emactuzumab|"In Cohort A1, Emactuzumab will be administered 1000 mg IV, every 3 weeks, starting on Cycle 1; Day 1 of a 21 day cycle.
~In Cohort A2, Emactuzumab will be administered 1000 mg IV, starting on Cycle 1 Day 1 of a 21 day cycle.
~In Cohort A2, in cycle 2-8, Emactuzumab will be administered 1000 mg IV, on day 1 of each 21 day cycle.
~In Cohort A2, Emactuzumab will be administered 1000 mg IV starting on Cycle 9; on Day 1 of each 21 day cycle"
15936435|NCT03369782|Drug|Placebo|"Placebo is administered as alternative to rocuronium in a bolus and in a syringe pump.
~Placebo is administered as alternative to sugammadex"
15972485|NCT03094052|Drug|Loperamide|Given PO
15936408|NCT03369964|Drug|Obinutuzumab|"In Cohort A2, Obinutuzumab will be administered 1000 mg IV starting on Cycle 1; Day 1 of a 21 day cycle
~In Cohort A2, Obinutuzumab will be administered again on days 8 and 15 (Cycle 1) of a 21 day cycle
~In Cohort A2, in cycle 2-8, Obinutuzumab will be administered 1000 mg IV on day 1 of each 21 day cycle"
15936409|NCT03369951|Drug|Minocycline|Minocycline is a semisynthetic derivative of tetracycline and is indicated for the treatment of infections due to susceptible isolates of designated microorganisms.
15936410|NCT03369938|Other|exercise training intervention|structured aerobic endurance/resistance training on top of usual care for 12 weeks (3x/week)
15936411|NCT03369925|Dietary Supplement|Placebo supplement|Cellulose
15936412|NCT03369925|Dietary Supplement|Citicoline supplement|Cognizin
15936413|NCT03369912|Biological|CSJ148|Active
15936414|NCT03369912|Other|Placebo|No Drug
15936415|NCT03369899|Device|FreeStyle Libre Flash Glucose Monitoring System|Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System and will receive no treatment except for safety purposes.
15936416|NCT03369886|Diagnostic Test|Optical Coherence Tomography Angiography (OCTA)|The images will be obtained using a commercial swept-source OCT (SS-OCT) device (DRI OCT Atlantis; Topcon, Tokyo, Japan). SS-OCT uses infrared light, wavelength of 1050 nm which is longer than conventional SD-OCT, at 100,000 A-scans per second. This longer infrared light source has advantages of deep signal penetration through the retina and choroid. Its axial and transversal resolution is 7 and 20 μm in tissue, respectively. Volumetric OCT scans were taken from 6 × 6 mm cubes. Each cube consists of 320 clusters of 4 repeated B-scans centered on the fovea. Moving objects (mostly blood flows) are detected by measuring intensity fluctuations from these repeatedly scanned OCT images. Automated segmentation was performed by OCT software to separate each layer of the retina. The en-face images of the superficial capillary network were derived from an en-face slab, ranged from the internal limiting membrane (ILM) to the inner border of the inner nuclear layer (INL).
15936417|NCT03369873|Other|Guidance Manual|The intervention group received of nursing orientation using a validated guidance manual about cardiac catheterization.
15936418|NCT03369860|Behavioral|Interactivity of Experimental Condition|The neurofunctional correlates of motor control will be compared between a collaborative and non-interactive condition.
15936419|NCT03369847|Drug|budesonide, beclomethasone|The inhaled corticosteroids we are using for this study are budesonide nebulized solution and beclomethasone metered-dose inhaler. Low-doses for these medications are 0.5mg/day for budesonide and 160 mcg/day for beclomethasone. Patients under 5 years of age will receive low dose budesonide solution 0.25mg/respule to be given twice a day via nebulizer. Budesonide is FDA approved for children under 5 years of age. Patients 5 years and older will receive one beclomethasone metered-dose inhaler (MDI) 40mcg/puff two puffs twice a day via spacer. Beclomethasone is FDA approved for children 5 years and older.
15936420|NCT03369834|Device|Red Light-emitting diode device|"The phototherapy will be applied for 3 days followed by a red LED blanket of 25x40 cm2, with equidistant distribution - 1 cm between them, with total energy per area of 180 J, bilaterally on the anterior tibial and triceps sural muscles, bilaterally. The intervention of these muscular groups is made possible by the distal involvement of diabetic polyneuropathy.
~All LEDs will be checked at the beginning of the project in the Laboratory of Photophysics of the Faculty of Philosophy, Sciences and Letters of Ribeirão Preto, University of São Paulo, in which the wavelengths will be checked, the angle of radiation, power and power density."
15936421|NCT03369834|Device|Infrared Light-emitting diode device|"The phototherapy will be applied for 3 days followed by a infrared LED blanket of 25x40 cm2, with equidistant distribution - 1 cm between them, with total energy per area of 180 J, bilaterally on the anterior tibial and triceps sural muscles, bilaterally. The intervention of these muscular groups is made possible by the distal involvement of diabetic polyneuropathy.
~All LEDs will be checked at the beginning of the project in the Laboratory of Photophysics of the Faculty of Philosophy, Sciences and Letters of Ribeirão Preto, University of São Paulo, in which the wavelengths will be checked, the angle of radiation, power and power density."
15936422|NCT03369834|Device|Infrared and Red Light-emitting diode device|"The phototherapy will be applied for 3 days followed by a infrared and Red LED blanket of 25x40 cm2, with equidistant distribution - 1 cm between them, with total energy per area of 180 J, bilaterally on the anterior tibial and triceps sural muscles, bilaterally. The intervention of these muscular groups is made possible by the distal involvement of diabetic polyneuropathy.
~All LEDs will be checked at the beginning of the project in the Laboratory of Photophysics of the Faculty of Philosophy, Sciences and Letters of Ribeirão Preto, University of São Paulo, in which the wavelengths will be checked, the angle of radiation, power and power density."
15936423|NCT03369834|Device|Sham|LED device off.
15936424|NCT03369821|Diagnostic Test|Beta Cell Loss and Immune Function|Beta cell loss (measured by serum/urine C-peptide), islet-specific autoantibodies, T1D risk genes and autoreactive CD8 T cells.
15936425|NCT03369821|Other|Immune Function with RNAseq|Immune function (measuring autoantibodies, autoreactive CD8 T cells and RNAseq of immune genes).
15936426|NCT03369808|Biological|7.5μg H7N9 Vaccine|The vaccine was a inactivated, whole virion preparation of the influenza A/Shanghai/2/2013(H7N9) virus, propagated in embryonated chicken eggs，mixed with aluminum hydroxide adjuvant.
15936427|NCT03369808|Biological|Phosphate Buffer Solution|0.5ml phosphate buffer solution
15936428|NCT03369808|Biological|Aluminum Hydroxide Adjuvant|0.5ml aluminum hydroxide adjuvant
15936429|NCT03369808|Biological|15μg H7N9 Vaccine|The vaccine was a inactivated, whole virion preparation of the influenza A/Shanghai/2/2013(H7N9) virus, propagated in embryonated chicken eggs，mixed with aluminum hydroxide adjuvant.
15936430|NCT03369808|Biological|30μg H7N9 Vaccine|The vaccine was a inactivated, whole virion preparation of the influenza A/Shanghai/2/2013(H7N9) virus, propagated in embryonated chicken eggs，mixed with aluminum hydroxide adjuvant.
15936431|NCT03369795|Drug|Methotrexate|Methotrexate 10mg once a week will be given for the first two weeks of the trial, followed by an increase in dose to 15mg or equivalent placebo once a week until week 16.
15936432|NCT03369795|Other|Placebo Arm|Pills equivalent to the study drug arm (10mg) will be given once a week for the first two weeks of the trial, followed by an increase in dose to 15mg of equivalent placebo once a week until week 16.
15936433|NCT03369782|Drug|Rocuronium|rocuronium is administered in bolus and continuous infusion
15936434|NCT03369782|Drug|Sugammadex|Sugammadex is administered just before reduction of the joint
15936436|NCT03369769|Other|Activity|10 minutes interaction with therapy dog and adult handler in small group (2-4 participants).
15936437|NCT03369756|Device|Prontosan Wound Irrigation Solution and Prontosan Wound Gel|Wound cleansing using Prontosan solution and gel
15936438|NCT03369717|Drug|Amoxi Clavulanate|Postoperative antibiotics
15936439|NCT03369704|Drug|Omalizumab|Omalizumab were administered by subcutaneous injection. Dose (75 to 600 mg) and dosing frequency (every 2 or 4 weeks) were determined by serum total IgE level (IU/mL) and body weight (kg) measured at the screening epoch according the dosing table.
15936440|NCT03369704|Drug|Placebo|Placebo were administered by subcutaneous injection. Dose (75 to 600 mg) and dosing frequency (every 2 or 4 weeks) were determined by serum total IgE level (IU/mL) and body weight (kg) measured at the screening epoch according the dosing table.
15936441|NCT03369665|Drug|Mavenclad®|Subjects will receive Mavenclad® 3.5 milligram per kilogram (mg/kg) of body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
15936442|NCT03369652|Behavioral|Medication review|Conducted by the pharmacist and discussed with hospital physician
15936443|NCT03369626|Behavioral|FareWell Program|The FareWell Program is a digitally delivered lifestyle management curriculum, which includes meal planning tools, daily self monitoring, personalized goal setting and bi-weekly live one-on-one health coaching.
15936444|NCT03369613|Device|transcranial electrical stimulation|The device is a Neoprene headcap that holds an array of padded electrodes close to the scalp to stimulate the underlying brain.
15936445|NCT03369600|Device|Supersonic Imagine Aixplorer SWE Ultrasound Imaging|Consented women will attend 2+ sessions where they will be imaged using the Supersonic Imagine Aixplorer for Shear Wave Elastography imaging.
15936446|NCT03369587|Behavioral|Handwriting Practice|Self-directed home handwriting practice daily for 6 weeks
15936447|NCT03369574|Drug|Reslizumab|reslizumab administration
15936448|NCT03369561|Diagnostic Test|Serum urea and creatinine and the calculated e GFR|The primary outcome will be AKI during the 1st 7 days of ICU care, as defined by an increase of ≥ 0.3 mg/dl in serum creatinine within 48 hours of ICU admission, an increase of ≥ 50% within 7 days of ICU admission, or acute dialysis
15936449|NCT03369548|Other|Apple|2 Renetta Canada apples and 2 placebo capsules/ day
15936450|NCT03369548|Other|Oats|40g jumbo rolled oats with semi-skimmed milk and 2 placebo capsules / day
15936451|NCT03369548|Dietary Supplement|Lactobacillus reuteri NCIMB 30242|2 probiotic capsules and 40g cornflakes with semi-skimmed milk / day.
15936452|NCT03369548|Other|Cornflakes|40g cornflakes with semi-skimmed milk and 2 placebo capsules/ day.
15936453|NCT03369535|Other|CARB rich diet|Consumed CARB rich diet for 6 weeks with a washout period of at least 2 weeks before the next intervention
15936454|NCT03369535|Other|MUFA rich diet|Consumed MUFA rich diet for 6 weeks with a washout period of at least 2 weeks before the next intervention
15936455|NCT03369535|Other|PROT rich diet|Consumed PROT rich diet for 6 weeks with a washout period of at least 2 weeks before the next intervention
15936456|NCT03369496|Other|Social capital; Neighborhood environment|Observational study examining the relationship among neighborhood environment, social capital and health among Montreal adults
15936457|NCT03369483|Other|Abdominal pressure assessment|We will perform measurements of the abdominal pressure an urinary catheter connected with an intra-abdominal pressure device (Uno-Meter ® - Unomedical) in all patients undergoing on open-surgical procedures after mechanical ventilation withdrawal and extubation, 30 minutes and 4 hours after the application of CPAP.
15936458|NCT03369470|Behavioral|App Dexterity|App based dexterity training by means of Finger Zirkus (see for more details: www.fingers-in-motion.de)
15936459|NCT03369470|Behavioral|Theraband|Active control being five traditional hand strengthening (Thera-band) exercises, which we published in our previous RCT, being feasible and effective in improving dexterity (for more details see for Kamm et al. 2015).
15936460|NCT03369457|Biological|Isolation of multipotent cells|Isolation of multipotent cells from patient's cells. Analysis of CFU and differentiation potential
15936462|NCT03369431|Dietary Supplement|Vivomixx|Multi-strain probiotic containing 450 billion lyophilized bacterial cells per sachet belonging to 8 probiotic strains. The probiotic strains contained in the intervention are Streptococcus thermophilus, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, Lactobacillus delbrueckii subsp. bulgaricus.
15936463|NCT03369431|Dietary Supplement|Placebo|4.4 grams of maltose and silicon dioxide per sachet
15936464|NCT03369418|Device|Alpha-Stim Active|The study device is a safe, commercially available take-home cranial electrotherapy stimulation device that applies an electrical current to a subject's head to treat anxiety, depression or insomnia
15936465|NCT03369418|Device|Alpha-Stim Inactive|The study device given to the inactive group will be identical to the active except the electrodes attached to the device will be inactive. The device will not transmit anything when turned on because the electrodes are inactive.
15936466|NCT03369405|Other|NO intervention, patient records review only|There is no intervention - the three study groups are created by utilizing three unique sets of search criteria for the patient records review.
15936467|NCT03369392|Other|Panda application|A smartphone-based postoperative pain management tool
15936468|NCT03369379|Drug|D3 Vitamin|Subjects will receive a capsule of 50,000 units of vitamin D3 echa week for 12 weeks, basal levels of vitamin D will be taken and again at week 12.
15936469|NCT03369379|Other|Placebo|Placebo pill
15936470|NCT03369366|Device|NobelActive|NobelActive's expanding tapered implant body condenses bone gradually while the apex with drilling blades enables a smaller osteotomy. These features help to achieve high primary stability in demanding situations, such as soft bone or extraction sockets. NobelActive enables immediate implant placement and Immediate Function where it might otherwise be challenging.
15936549|NCT03368794|Behavioral|Control|Written information from ambulance staff to the patient about how to seek treatment. Patient is able to contact the research treatment facility through a specific phone number, making it possible to study treatment entry in the information-only control condition.
15936665|NCT03367910|Drug|Fecal microbiota transplant|150mL of FMT product RBX2660 delivered via enema
15936471|NCT03369366|Device|KLS Martin Mandibular Reconstruction Implant|The prefabricated prosthesis will be secured onto the implants using non-engaging multiunit abutments with screws, followed by fixation of the patient-specific plate to the fibula with monocortical screws. The previously used cutting guides are fixated with the screw locations corresponding to the screw locations of the custom plate. This allows for accurate positioning and fixation of the custom construct of the plate and fibula without the need for intermaxillary fixation (IMF).
15936472|NCT03369340|Other|P3P 1|2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm
15936473|NCT03369340|Other|P3P 2|2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
15936474|NCT03369340|Other|P3P 3|1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm
15936475|NCT03369340|Other|P3P 4|2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
15936476|NCT03369327|Drug|sofosbuvir and daclatasvir|"Depending on the ART received by each patient one of the fixed-dose combination pills below will be used:
~Daclatasvir 30 mg and sofosbuvir 400 mg
~Daclatasvir 60 mg and sofosbuvir 400 mg
~Daclatasvir 90 mg and sofosbuvir 400 mg"
15936477|NCT03369314|Drug|octaplasLG®|Data will be collected in all patients who have received at least one infusion of octaplasLG®
15936478|NCT03369301|Drug|Gammanorm|Gammanorm given per standard of care
15936479|NCT03369301|Drug|Other Subcutaneous Immunoglobulins|Other Subcutaneous Immunoglobulins given per standard of care
15936480|NCT03369288|Diagnostic Test|PET MRI|18F-fluoride PET-MRI
15936481|NCT03369275|Biological|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells|Cryopreserved Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously.
15936482|NCT03369275|Other|Placebo|Placebo, with excipients, will be administered intravenously.
15936483|NCT03369262|Drug|OBE022|Oral
15936484|NCT03369262|Drug|Placebos|Oral
15936485|NCT03369262|Drug|Atosiban|I.V.
15936486|NCT03369249|Behavioral|Link2CARE|The Link2CARE intervention consists of 4 sessions. Session 1 consists of a one-on-one meeting with a Health Coach, during which participants will be offered an oral rapid HIV test and STI test. Sessions 2, 3, and 4 are group-based. During these sessions, participants will engage in discussions and activities regarding sexual and substance use risk behaviors.
15936487|NCT03369236|Drug|ACH-0144471|All participants randomized to the treatment arm will receive 6 months of active study medication ACH-0144471. At the time of treatment completion, drug will be tapered as appropriate.
15936488|NCT03369236|Drug|Placebo|All participants randomized to the placebo arm will receive 6 months of placebo medication. At the time of treatment completion, drug will be tapered as appropriate.
15936489|NCT03369223|Biological|BMS-986249|specified dose on specified day
15936490|NCT03369223|Biological|Nivolumab|Specified dose on specified days
15936491|NCT03369223|Biological|Ipilimumab|Specified dose on specified days
15936492|NCT03369210|Drug|red blood cell transfusion trigger|patients receive a RBC unit with different target ranges for the post-transfusion Hb levels
15936493|NCT03369197|Device|Nasal Mask|Nasal anesthesia mask which covers the nose and attaches to the anesthesia circuit, allowing for variable positive pressure by setting the pop-off valve
15936494|NCT03369197|Device|Control: Nasal Cannula|Nasal cannula as per usual care
15936495|NCT03369184|Drug|Oxygen gas|The intervention is administered as previously described. The duration of intervention is 10 minutes.
15936496|NCT03369184|Other|Ambient air|Administered similarly to treatment arm, via an open face mask and during 10 minutes
15936497|NCT03369171|Device|Myo Armband (MYO,Thalamic Labs Inc, Kitchener, ON, Canada)|"MYO armband is a commercialized, gesture control device containing Height Medical Grade Stainless Steel EMG sensors, and an inertial measurement unit (IMU) consisting of a three-axis gyroscope and a, three-axis accelerometer, three-axis magnetometer. MY0 motion data (EMG and IMU) will be recorded during standard motor/neurological evaluation.
~The clinical assessment will include standard motor neurological evaluation : EDSS and FS, walking status, foot tapping test, Heel-knee test, finger tapping test, Finger to nose test, Romberg test, timed 25 foot walk test, nine holes peg test. This clinical assessment will be done at the inclusion visit (V1) and at the follow-up visit at one year (V2)."
15936498|NCT03369158|Procedure|patient specific pedicle screw positioning guide|
15936499|NCT03369158|Procedure|Free hand technique pedicle screw positioning|
15936500|NCT03369158|Device|MUST pedicle screw|
15936501|NCT03369145|Dietary Supplement|High-fat diet|The high-fat diet will provide 7 days of overfeeding comprising of: +50% extra calories above the daily required intake, 65% of which is fat.
15936502|NCT03369132|Device|Angiflash|throat spray (20 ml) containing hypertonic seawater, vegetable glycerin, natural mint, acacia honey, propolis extract, essential oils of thyme linalool, ravintsara and wintergreen, natural lemon flavor.
15936503|NCT03369132|Device|Placebo|water based throat spray matching Angiflash for posology, dispensed volume, shape and size.
15936504|NCT03369119|Drug|Montelukast 4 Mg Oral Granule|
15936505|NCT03369119|Drug|Placebos|
15936506|NCT03369106|Other|Composite severity score calculation|Neurological examination, cognitive testing, and MRI exam
15936507|NCT03369093|Drug|Amoxicillin|Twice daily doses of injectable amoxicillin
15936508|NCT03369067|Device|Tandem t:slim X2 with Control-IQ Technology + Dexcom G6|Subjects will use the Tandem t:slim X2 with Control-IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor [CGM].
15936509|NCT03369067|Device|Dexcom CGM G5|"The Dexcom G5 CGM is a subcutaneous glucose sensor that provides an estimate of the prevailing blood glucose concentration approximately every 5 minutes.The Dexcom G5 sensor alerts the user if the prevailing glucose concentration is higher or lower than predetermined thresholds, or if it is changing too fast. In addition, the Share/Follow functionality of the Dexcom G5 allows up to 5 people (followers) to receive in real-time information about the current blood glucose concentration and rate of change.
~The Dexcom G5 system will be used by participants and clinical study staff to monitor glucose levels 24h/day during the camp, ensure participants safety, and compute glycemic control outcomes"
15936510|NCT03369067|Device|Continuous Subcutaneous Insulin Infusion|Subjects will use a subcutaneous pump to deliver insulin and control their glycemia.
15936511|NCT03369054|Behavioral|Minority Stress Treatment|"The (MST) condition will include a psychoeducation session on minority stress for all participants during the initial assessment session prior to their first psychotherapy session. Prior to attending each of the 12 psychotherapy sessions during their electronic assessment (filling out the OQ-45 on Qualtrics on a computer provided by the study team), patients will be prompted to report up to three minority stress experiences over the previous week in the survey tool (which the therapists will not see). They will be prompted by their therapist to discuss these experiences within their psychotherapy sessions (for example, Would you like to discuss any of the minority stress experiences you've had over the week?)."
15936512|NCT03369054|Behavioral|Treatment As usual|Treatment-as-usual (TAU) will occur as any usual 12-week treatment. The therapists will be encouraged to discuss any of the presenting concerns reported by patients and supervision will include usual care.
15936513|NCT03369041|Drug|Irinotecan-Eluting Beads|
15936514|NCT03369028|Other|2D and 3D image of infants´ faces|2D and 3D image of infants´ faces
15936515|NCT03369015|Drug|10 mg d-amphetamine|10 mg d-amphetamine dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.
15936516|NCT03369015|Drug|20mg d-amphetamine|20 mg d-amphetamine dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.
15936517|NCT03369015|Drug|Placebo|Placebo dose given (double-blind) and behavioral tasks (EEfRT, PRT, ELT, CGT) administered.
15936518|NCT03369002|Drug|seladelpar|Oral single dose 10 mg
15936519|NCT03368989|Drug|Radium-223 dichloride|Previously known as Alpharadin, Radium-223 dichloride is a calcium-mimetic, alpha emitting radiopharmaceutical, which introduces double-stranded DNA breaks in metastatic cancer cells.
15936520|NCT03368963|Drug|Nanoliposomal Irinotecan|Given IV
15936521|NCT03368963|Drug|Trifluridine and Tipiracil Hydrochloride|Given PO
15936522|NCT03368950|Other|Online Mindfulness Course|An online mindfulness course guiding participants through all elements of Mindfulness-Based Cognitive Therapy (MBCT) and Mindfulness-Based Stress Reduction (MBSR). Ten easy-to-follow sessions with videos and interactive exercises led by leading mindfulness trainers.
15936523|NCT03368937|Device|Tandem t:slim X2 with Control-IQ Technology|Subjects will wear the Tandem t:slim X2 with Control-IQ Technology during a 36-48 hour hotel admission.
15936524|NCT03368924|Other|SCA patients (SS genotype)|"The clinical data relative to the patients will be collected in each of these stages (CVO, basic state).
~Besides, to estimate the severity of the CVO, we shall use an index of severity of the episode ( IS2) adapted from the one who was validated by our group to stratify the severity of vasoocclusifs episodes at the drepanocytic child SS.
~Main clinical parameters: taken of analgesic at home (level), temperature in the admission, SaO2 in the admission, number of painful sites, thoracic pain with or without associated cough, score EVA in the entrance, feeling of the patient of bigger gravity of the CVO with regard to its crises previous, heart rate to the admission, … Main biological parameters: rate of leukocytes, of polynucléaires neutrophiles, of réticulocytes, Lactate déshydrogénase, of haemoglobin, C-reactive Protein … The biological data can be studied according to their raw rate or according to their difference with their basic value (in the stable state)."
15936525|NCT03368911|Device|Oral/Nasal Endotracheal Tube, Reinforced (Covidien)|Use Oral/Nasal Endotracheal Tube, Reinforced (Covidien) for endotracheal intubation
15936526|NCT03368911|Device|TaperGuard oral tracheal tube (Covidien)|Use TaperGuard oral tracheal tube (Covidien) for endotracheal intubation
15936527|NCT03368885|Other|Maternal dietary diversity|Counsel pregnant women for proper dietary intake and create awareness among family members and community to support her on maternal nutrition
15936528|NCT03368885|Other|Diet diversity in complementary feeding|Counsel mothers of children of 6-23 months on diet diversity in complementary feeding by demonstration during home-visits and seek support from father and family members
15936529|NCT03368885|Other|Exclusive Breast Feeding|Counselling on exclusive breast feeding among children under 6 months-Provide information to mothers of children of 3-6 months for exclusive breast feeding through home visits, and mothers meetings
15936530|NCT03368885|Other|Community mobilization|Engagement of local/religious leader, husbands to support diet diversity for pregnant women and doctors and fathers to support diet diversity for complementary feeding
15936531|NCT03368885|Other|Capacity Building|Capacity Building-Training of Community mobilization coordinator and mentoring for knowledge enhancement on nutrition for pregnant women and children below 2 years
15936532|NCT03368885|Other|Use of existing platforms VHSND|Convergence- Strengthen Village Health Sanitation and Nutrition Day for creating awareness on diet diversity for maternal nutrition and complementary feeding
15936533|NCT03368885|Other|Strategic use of data|Strategic use of data-Data analysis for concurrent monitoring,planning and decision making to improve the performance of CMCs
15936534|NCT03368872|Other|Astaxanthin formulation|Astaxanthin formulation containing AstaReal® astaxanthin (Haematococcus pluvialis algae extract), tocotrienol, and zinc will be orally administered starting on Day 1 until Day 120
15936535|NCT03368872|Other|Placebo|Placebo will be orally administered starting on Day 1 until Day 120.
15936536|NCT03368872|Other|Exercise training|The subjects will undergo interval treadmill incline protocol (target 85% HR max, 3 times a week for 40 to 60 minutes) starting on Day 31 until Day 120.
15936537|NCT03368859|Drug|Leucovorin|Intravenous
15936538|NCT03368859|Drug|Fluorouracil - bolus|Intravenous
15936539|NCT03368859|Drug|Bevacizumab|Intravenous
15936540|NCT03368859|Drug|Fluorouracil - infusion|Intravenous
15936541|NCT03368859|Drug|ABT-165|Intravenous
15936542|NCT03368859|Drug|Irinotecan|Intravenous
15936543|NCT03368846|Drug|Varlitinib|[14C]-Varlitinib
15936544|NCT03368833|Diagnostic Test|Electrocardiogram|12-lead ECG will be obtained after induction and at 5, 10, 20, 30, and 60 minutes after the caudal epidural block.
15936545|NCT03368820|Other|No intervention|Treatment left at the discretion of the participant
15936546|NCT03368807|Device|Continuous Glucose Monitoring|Commercially available
15936547|NCT03368807|Drug|Insulin Lispro|As prescribed.
15936548|NCT03368794|Behavioral|Active treatment referral of opioid overdose survivors to long-term treatment|Telephone alert and outreach for inclusion, assessment and intake into long-term evidence-based treatment of the substance use disorder.
15936727|NCT03367429|Drug|Botox|Please see arm descriptions for intervention description.
15936550|NCT03368781|Device|AcQMap Imaging and Mapping System|3D Cardiac Imaging and Mapping during ablation procedures
15936551|NCT03368768|Other|Obtain inform consent via questionnaire of Monkey Survey|This is an internet-based questionnaire study. Therefore, anyone in Thailand can access and answer the questionnaire.
15936552|NCT03368755|Diagnostic Test|Cardiopulmonary Exercise Testing|Pimax, Pemax, airway pressure at 100 msec after occlusion (P0.1), and Ti and Ttot will be measured by the Micro 5000 device (Medisoft, Sorinnes, Belgium). TTImus will be calculated as (Pimean / Pimax) x (Ti / Ttot), where Pimean is the mean airway pressure resulting from the formula Pimean = 5 x P0.1 x Ti9. RM function will be determined a) prior to CPET, b) during CPET when the anaerobic threshold (AT) will be reached, and c) after CPET, when heart rate (HR) and oxygen consumption will be normalized.
15936553|NCT03368755|Diagnostic Test|Respiratory Muscle Strength and Endurance|CPET will be performed by the Ultima CPX system (Medgraphics, St. Paul, USA), using a cycle ergometer and according to a standardized protocol. The following parameters will be recorded: total work in Watts, maximum HR, maximum oxygen consumption (VO2max), AT indices (work, HR, VO2 ) and duration of recovery.
15936554|NCT03368742|Genetic|SGT-001|AAV9 vector containing muscle-specific promoter and microdystrophin construct
15936555|NCT03368729|Drug|Niraparib|Niraparib is an oral PARP-1 and -2 inhibitor with high potency.
15936556|NCT03368729|Drug|Trastuzumab|Trastuzumab is a commercially available agent administered by intravenous infusion. A loading dose of 8 mg/kg will be given as the first dose followed with all subsequent doses of 6 mg/kg every 3 weeks.
15936557|NCT03368716|Behavioral|Acceptance-based Behavioral Treatment (ABBT)|ABBT is rooted in behavioral therapy but also cultivates self-regulation skills including experiential acceptance of potentially uncomfortable internal experiences (e.g., emotions, cravings), mindful awareness of decision making (e.g., mindful eating), and values clarification and behavioral commitment (e.g., practicing daily physical activity to be a contributing member on a sports team). ABBT has been used effectively to help youth and adults manage various medical and psychological problems. Moreover, components of ABBT have been shown to improve child and adult EF including inhibitory control and cognitive flexibility. Recently, ABBT has been integrated with components of standard behavioral treatment of obesity and applied with robust efficacy to weight management in adults.
15936558|NCT03368703|Device|Anodal transcranial direct-current-stimulation|2mA / 20min Anodal and Sham tDCS over dominant M1. Anodal tDCS consists of 30s of ramp up followed by 20min of stimulation and 30s of ramp down.
15936559|NCT03368703|Device|Sham transcranial direct-current-stimulation|"Sham tDCS consists of only 30s of ramp up followed by 30s of ramp down and no further stimulation.
~Participants therefore have the same feeling for both modalities : slight itching due to the induced current at the beginning of the protocol (during around 30s) allowing no differentiation by the participant between the anodal or sham sessions."
15936560|NCT03368690|Dietary Supplement|Oligopin®|At the treatment period (0th to 4th week of the experiment), subjects with ADHD will receive 1~3 capsules of polyphenolic extract from pine bark (25mg or 50 mg Oligopin per capsule) according to their body weight and age. The 5th to 6th week will be the washout period. The control group and Oligopin group will be cross-over at 7th week to 10th week of the experiment.
15936561|NCT03368690|Other|Placebo|At the treatment period (0th to 4th week of the experiment), subjects with ADHD will receive 1~3 capsules of polyphenolic extract from pine bark (25mg or 50 mg Oligopin per capsule) according to their body weight and age. The 5th to 6th week will be the washout period. The control group and Oligopin group will be cross-over at 7th week to 10th week of the experiment.
15936562|NCT03368664|Drug|Alemtuzumab GZ402673|Pharmaceutical form:solution Route of administration: intravenous
15936563|NCT03368664|Drug|Glatiramer acetate|Pharmaceutical form:solution Route of administration: subcutaneous
15936564|NCT03368664|Drug|Beta-Interferon|Pharmaceutical form:solution Route of administration: subcutaneous / intramuscular
15936565|NCT03368664|Drug|Methylprednisolone|Pharmaceutical form:solution Route of administration: intravenous
15936566|NCT03368664|Drug|Ranitidine|Pharmaceutical form:tablet Route of administration: oral
15936567|NCT03368664|Drug|Ceterizine|Pharmaceutical form:tablet Route of administration: oral
15936568|NCT03368664|Drug|Dexchlorpheniramine|Pharmaceutical form:tablet Route of administration: oral
15936569|NCT03368664|Drug|Paracetamol|Pharmaceutical form:tablet Route of administration: oral
15936570|NCT03368664|Drug|Acyclovir|Pharmaceutical form:tablet Route of administration: oral
15936571|NCT03368664|Drug|Prednisolone|Pharmaceutical form:tablet Route of administration: oral
15936572|NCT03368664|Drug|Diphenydramine|Pharmaceutical form:solution Route of administration: intravenous
15936573|NCT03368664|Drug|Other H1 antagonist|Pharmaceutical form:solution Route of administration: intravenous
15936574|NCT03368664|Drug|Other H1 antagonist|Pharmaceutical form:tablet/pill Route of administration: oral
15936575|NCT03368651|Procedure|TAI|transarterial chemoinfusion with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
15936576|NCT03368638|Other|Physical therapy intervention|Double knee to chest stretches, hip extension mobilization, neural mobilizations, home exercises program
15936578|NCT03368612|Other|Electronic evaluation system|spirometry, plethysmography, cardiopulmonary exercise test
15936579|NCT03368612|Other|Electronic evaluation system|AirGo recording
15936580|NCT03368599|Procedure|Bronchoscope guided advancement|"During the anesthetic induction for thoracic surgery, Lt. DLT is intubated using the bronchoscope-guided method. The method is as follows.
~Lt. DLT is intubated through vocal cord using the direct laryngoscopy.
~Pass the fiberoptic bronschoscope through a bronchial lumen of Lt. DLT.
~Secure the pathway into the Lt. main bronchus by advancing the bronchoscope into the Lt. main bronchus.
~Lt. DLT can be advanced through the guide of the bronchoscope into Lt. main bronchus.
~After the advancement, the position of Lt. DLT can be confirmed using the fiberoptic bronchoscope. If necessary, the depth and direction of Lt. DLT should be modified."
15936654|NCT03367962|Drug|[18F]F-Ara-G|the [18F]F-AraG tracer will be administered as a single bolus injection of approximately 5 mCi into a hand or arm vein.
15936655|NCT03367949|Other|Surgical guide designed from Impression inversion with markers|Rather than using optical scan of the cast , We will use impression inversion technique with VPS impression and adding CBCT Markers on the tray
15936581|NCT03368599|Procedure|Conventional advancement|"During the anesthetic induction for thoracic surgery, Lt. DLT is intubated using the conventional method. The method is as follows.
~Lt. DLT is intubated through vocal cord using the direct laryngoscopy.
~Rotate Lt. DLT 90 degrees to the left side.
~Advance Lt. DLT blindly to main bronchus level.
~After the advancement, the position of Lt. DLT can be confirmed using the fiberoptic bronchoscope. If necessary, the depth and direction of Lt. DLT should be modified."
15936582|NCT03368586|Device|Flash Glucose Monitoring|The camp comprised a structured daily routine with five fixed meals: breakfast, lunch, afternoon snack, dinner and evening snack. Capillary blood glucose (BG) values were measured in parallel with unmasked Flash Glucose (FG) measurements using the FGM reader's built-in glucometer at breakfast, lunch and dinner. Additional measurements were taken before snacks, between the meals or overnight and BG was measured only in cases of low (<4.0 mmol/L) or high (>15.0 mmol/L) FG values or when symptoms were discordant with sensor readings. Sensor-related issues were documented and a questionnaire assessing satisfaction and usability of the FGM was completed by patients and caregivers at study completion.
15936583|NCT03368573|Device|QbTest|QbTest is a computerised assessment which takes approximately 20mins. The test combines a continuous performance test alongside an infrared camera which measures the participant's movements. The infrared camera measures motor activity of the participant whilst they undertake the task. During the test, the participant is presented with continuously changing stimuli. Embedded within these stimuli is a given target. Participants have to respond by pressing a hand-held button only when the target appears. Attention is measured through omission errors and reaction time to response. Impulsivity is assessed through commission errors and anticipatory errors. Motor activity is measured through head movements during the task. The test is approved by the FDA (Ref: K133382) and CE marked.
15936584|NCT03368560|Other|Sudarshan Kriya Yoga|Sudarshan Kriya Yoga (SKY): A 12-week training course conducted by certified instructors from the Art of Living Foundation. SKY training will take place in group-format (group sizes of 8-15 participants) in an appropriately sized and accessible community hall in London, Ontario.SKY training involves attending a week-long (5 days) course that teaches the basic principles of SKY over 2.5-3 hour daily sessions. This will be followed by once weekly follow up sessions (90 min/wk) for 3 weeks and then bimonthly sessions (every 2 weeks) for the next 8 weeks. In addition, participants will be asked to practice SKY at home daily (25 min/day) throughout the duration of the study period and log practice frequency and any other noteworthy observations in a log sheet that will be provided to them . Nutritional snacks will be provided during the 5 day SKY training course.
15936585|NCT03368547|Procedure|Computed Tomography|Undergo PET/CT scan
15936586|NCT03368547|Radiation|Gallium Ga 68 Gozetotide|Given IV
15936587|NCT03368547|Procedure|Positron Emission Tomography|Undergo PET/CT scan
15936588|NCT03368534|Device|Autologous Regenerative Technology (ART)|ART device with single-needle, fluid-assisted skin tissue harvesting technology.
15936589|NCT03368521|Other|Back pain screening test|The care giver use the screening tool in order to score the back patient to three levels of risk. For each level of risk, one suggested type of care is provided; 1) simple advise; 2) physiotherapy; 3) multimodal rehabilitation. highest risk level includes multimodal intervention.
15936590|NCT03368508|Behavioral|Simulating video|A 360-degree simulating video showing physiotherapy assessment in lumbar area
15936591|NCT03368508|Behavioral|Conventional video|A conventional video showing physiotherapy assessment in lumbar area
15936592|NCT03368495|Biological|Co-administration of MMR/YF|Both MMR & yellow fever vaccines administered on Day 0.
15936593|NCT03368495|Biological|MMR followed by YF|MMR vaccine administered on Day 0 and yellow fever vaccine administered on Day 28.
15936594|NCT03368495|Biological|YF followed by MMR|Yellow fever vaccine administered on Day 0 and MMR vaccine administered on Day 28.
15936595|NCT03368482|Behavioral|Brain Gym Exercises|"Participants in the BrainGym Exercises group performed six of the following BG exercises in every training session they took part in: Cross Crawl, Gravity Glider, Arm Activation, Belly Breathing, Hook-ups, Think of an X, Lazy Eights, Elephant, Space Buttons, The Owl, Energy Yawn, Balance Buttons and The Energizer. All exercises were executed from a sitting position but following the main tenets of the Brain Gym® work routine."
15936596|NCT03368482|Behavioral|Standard exercise program for institutionalized older adults.|Participants in the Standard Exercise group took part in a traditional physical exercise program designed for institutionalized elderly people aimed at increasing their range of mobility and coordination, specifically focused on the lower limbs.
15936597|NCT03368469|Device|transcranial direct current stimulation|The Soterix Medical 1×1 Low Intensity Transcranial DC Stimulator Model 1300A is an investigational device manufactured by Soterix Medical, Inc. (New York, NY, USA). It is designed for use in noninvasive transcranial stimulation of the brain by delivering low-intensity electrical current to the scalp through two electrodes.
15936598|NCT03368456|Behavioral|S4E|S4E application was developed in collaboration with youth in Southeast Michigan. S4E aims to prevent and reduce HIV/STI risk behaviors, including drug use and sexual risk behaviors, and increase HIV/STI testing among youth. Content produced for the application is based on scientific prevention principles in conjunction with youth input. To date, we have developed modules focused on youth alcohol & drug use, HIV & STIs and a forthcoming module on tobacco prevention and cessation.
15936599|NCT03368456|Behavioral|Usual Care|Participants in Usual Care (i.e., Control Condition) will not receive the S4E intervention from the study staff. The Clinic's usual care includes a standard risk behaviors intake form, pamphlets highlighting resources, and reproductive and healthcare services.
15936600|NCT03368443|Behavioral|treadmill training and overground gait training|The participants will be randomized into two different groups, and they will receive treadmill and overground gait training in one or two rooms.
15936601|NCT03368430|Dietary Supplement|Melatonin|After performing scaling and root planing (SRP) in the test group, melatonin 10 mg oral capsule was taken once daily at night prior to bedtime for only 2 months during the 6-month study period
15936602|NCT03368430|Drug|Placebo|After finishing scaling and root planing (SRP) in the control group, placebo capsule was taken once daily at bedtime for two months.
15936656|NCT03367936|Behavioral|One-on-one Session|Participants will receive a 45-minute one-on-one behavioral lifestyle program for a healthful lifestyle and weight loss.
15936657|NCT03367936|Behavioral|Self-monitoring|Participants will receive an orientation on how to self-monitor using the smartphone and other devises
15936603|NCT03368417|Other|Usual Care|"Participants will be advised to measure their BP at least 3 times a week and record their results on a form. The participants will be educated on how to interpret their BP according to standard self-monitoring practice guidelines.
~As part of the study, participants without a HBPM will be provided with the Omron HEM 7130. Adherence to hypertensive medicines will be monitored using the medication event monitoring system eCAP™. In addition, the participants will be asked to undertake ambulatory blood pressure monitoring (using the Welch Allyn ABPM 7100 monitor) at Baseline and Month 6 for a duration of 12 hours, during their waking hours."
15936604|NCT03368417|Other|Wireless HBPM System|"BP will be monitored using the iHealth KN-550BT wireless HBPM and transmitted to the study application via the iHealth mobile application.
~The Wireless HBPM System consists of:
~i) Instant BP feedback: Classification of each BP reading with feedback SMS. CRC will call the patient in case of alarming BP readings.
~ii) Weekly HBPM adherence feedback: Participants receive praise, encouraging, or reminder SMSes.
~iii) Continuous assessment: Based on average BP over the last 4 weeks, participants will be categorized and flagged for the CRC to follow clinical protocols. Protocols include asking patients to immediately come to the clinic, checking for alarm symptoms and discussing adherence over the phone, remote titration, and cancelling 1 clinic visit in case of good BP control."
15936605|NCT03368417|Behavioral|BP Monitoring Incentives|"Participants will receive an intervention identical to those in the Wireless HBPM System, with financial incentives for BP monitoring. This arm is further randomly subdivided into the Instant Reward and Health Capital arms in a 1:1 ratio.
~Instant Reward sub-arm:
~Participants receive SGD 3 for each day they measure their BP, up to three times per week.
~Participants do not receive financial incentive if they do not measure their BP.
~Health Capital sub-arm:
~Participants receive an initial health capital of SGD 72
~Participants' health capital increases by SGD 6 on each week where they measure their BP on at least 3 different days and decreases weekly by 10% per missing BP reading."
15936606|NCT03368404|Device|CBL-102 eye drops|CBL-102 eye drops, 3 to 6 times per day for 3 months
15936607|NCT03368404|Device|Vismed Multi eye drops|Vismed Multi eye drops, 3 to 6 times per day for 3 months
15936608|NCT03368391|Drug|tetracaine HCl and oxymetazoline HCL|0.4 mL HCl and oxymetazoline HCl administered intranasally
15936609|NCT03368391|Drug|2% Lidocaine with 1:100,000 epinephrine|2.5 mL of 2% Lidocaine with 1:100,000 epi will be infiltrated at anterior teeth
15936610|NCT03368391|Drug|3% Mepivacaine with 1:100,000 epinephrine|2.5 mL of 3% Mepivacaine will be infiltrated at anterior teeth
15936611|NCT03368391|Drug|saline intranasal|0.4 mL intranasal saline will be administered as a placebo
15936612|NCT03368391|Drug|saline infiltration|2.8 mL of saline will be infiltrated at anterior teeth as a placebo
15936613|NCT03368378|Procedure|Early DVC ligation|After the posterior isolation of seminal vesicles, the Retzius space will be accessed and the endopelvic fascia will be incised. The DVC will be identified and incised. The DVC will be then selectively ligated using a V-lok 3/0 barbed suture. This approach would allow for the preservation of the external urethral sphincter and for the identification and preservation of the neurovascular bundles that are located in the anterolateral aspect of the prostate. After the early DVC isolation, incision and ligation, the bladder neck will be incised and preserved when possible. A posterior nerve sparing approach will be then performed. During apical dissection, the urethral sphincter will be identified and carefully preserved. Posterior reconstruction and anastomosis will be then performed.
15936614|NCT03368365|Device|Ventilotel ®|Using of the spirometer of Aqsitania company, Ventilotel ®, to analyse the respiratory function at rest and to predict unplanned hospitalizations.
15936615|NCT03368352|Dietary Supplement|Melatonin|Dietary supplement melatonin
15936616|NCT03368352|Other|Hypoxia|Sleep in a hypoxic tent simulating high altitude
15936617|NCT03368339|Drug|PR013 (0.045%)|PR013 topical Ophthalmic Drops (0.045%)
15936618|NCT03368339|Drug|PR013 (0.06%)|PR013 topical Ophthalmic Drops (0.06%)
15936619|NCT03368339|Drug|Vehicle|Vehicle
15936620|NCT03368326|Diagnostic Test|Critical-Care Pain Observation Tool (CPOT)|The CPOT includes 4 behaviors: (1) facial expression, (2) body movements, (3) compliance with the ventilator, and (4) muscle tension. Each behavior is rated from 0 to 2 for a possible total score ranging from 0 to 8.
15936621|NCT03368313|Device|Circaid|Circaid is a velcro compression device for the calf (Circaid Juxtalite® Lower Leg; Medi Gmbh, Bayreuth, Germany), thigh and knee (Circaid Juxtafit; Medi Gmbh, Bayreuth, Germany). The Circaid device will be applied with an average pressure of more than 40 mmHg, verified through a BPS (built-in pressure system).
15936622|NCT03368300|Other|Clinical and biological exam|"The study will include a clinical, neuropsychological, oculomotor, food intake and environmental exposure assessment. Blood samples will be taken to constitute a library of plasma, DNA and serum. The harvesting of samples will be part of a subsequent study. Consent for possible post-mortem neuropathological analysis will be proposed.
~All the patients accepting it will be followed by a 5-year longitudinal follow-up. The longitudinal follow-up bi-annual and then annual will include a clinical evaluation, a questionnaire of dependence and a questionnaire of monitoring of exposure to certain environmental factors
~All controls must answer a questionnaire of environmental exposure factors, oculomotor test, and blood sample (3 collections: DNA, serum, plasma)."
15936623|NCT03368287|Device|Fitbit One, the activity tracker|Activity tracker, Fitbit One, will be used for a week to evaluate the steps of daily life before the surgery and at the time of follow up.
15936624|NCT03368274|Drug|T 614|Patients of IgG4-RD with mild symptoms are given one dose of diprospan and Iguratimod, 25mg, Bid.
15936625|NCT03368261|Other|HTAP/ clinical complications in the sickle cell disease|At the inclusion in our study the diagnosis of PAH will be performed by transthoracic Doppler-echocardiograms in a group of 306 children (aged between 8 to 16 years old) with either SS or SC genotype with similar medical caring, to avoid a known selection bias. These patients will be followed during a 3 years longitudinal period. The occurrence of the clinical specific complications associated with SCD (acute chest syndrome, painful vaso occlusive crisis, septicemia and stroke) and the observed mortality rate of our children group, will be compared in patients groups stratified according to the occurrence of PAH. The expression of several molecular and cellular genetic biomarkers potentially associated with this complication will also be studied.
15936658|NCT03367936|Behavioral|Feedback|Participants will receive up to 4 daily feedback messages based on progress in attaining target behavior. The feedback messages will be delivered on a variable ratio schedule and tailored to data in subjects' dietary recordings
15936626|NCT03368248|Other|Survey|A survey was conducted among all professionals in neonatal resuscitation services : doctors (senior and intern), paramedics (managers, pediatric nurses, auxiliaries and nurses, psychomotor therapists) and psychologists. The survey was based on a questionnaire, which was offered to all professionals, both medical and non-medical. All questions were closed, and a free comment area was proposed at the end. The questionnaire was preceded by a comment recalling the objectives of the study, the voluntary and individual nature of participation, and insisted on respect for anonymity. It consisted of 49 questions, allowing 197 possible answers. For most questions, several answers could be chosen.
15936627|NCT03368235|Drug|AZD9567|oral OD SGRM administered as suspension
15936628|NCT03368235|Drug|Prednisolone|oral capsules of 20 mg prednisolone administered OD for two weeks
15936629|NCT03368209|Device|WM3.4|Investigational Medical Device collecting spectral raman data from tissue.
15936630|NCT03368196|Drug|DS-8201a|An antibody drug conjugate
15936631|NCT03368183|Other|Care delivery algorithim|SCAMP
15936632|NCT03368170|Drug|Mesdopetam (IRL790)|Mesdopetam (IRL790) capsule
15936633|NCT03368144|Device|ClearLumen II Peripheral Thrombectomy System|Patients will be treated with the ClearLumen Peripheral Stent Graft System
15936634|NCT03368131|Drug|Trastuzumab|intravenously administered with the loading dose of 8 mg/kg followed by maintenance dose of 6mg/kg in day 1 of each cycle
15936635|NCT03368131|Drug|Capecitabine|825~1000mg/m2 bid d1-14
15936636|NCT03368131|Drug|Oxaliplatin|130 mg/m2 Ivgtt d1 q3w
15936637|NCT03368131|Radiation|Radiotherapy|45 Gray (unit) Gy/25f （1.8Gy/f/d，5 f/w）
15936638|NCT03368118|Drug|ABX464|All subjects will receive ABX464 given at 50 mg o.d for an overall period of 48 months.
15936639|NCT03368105|Dietary Supplement|Prevention of C. difficile infections using LP299v strain|"Patients treated with antibiotics and at high CDI risk (patients after organ transplantation or receiving immunosuppressive therapy for any other reason) will be enroll to study.
~We will divide participants into two group. Group 1 will receive one capsule of LP299v orally per a day during the entire period of antibiotic therapy. Group 2 will receive one capsule of placebo during the entire period of antibiotic therapy."
15936640|NCT03368092|Drug|Dornase Alfa Inhalant Solution [Pulmozyme]|Dornase alfa (Pulmozyme®, Roche 2500U, 2,5mL) given by aerosol in the respiratory circuit (Aerogen solo®) within 6h at day 1 and 24 hours after on day 2.
15936641|NCT03368092|Drug|Placebos|NaCl 0,9%, given by aerosol in the respiratory circuit within 6h at day 1 and 24 hours after on day 2.
15936642|NCT03368079|Device|Negative Pressure Suction Catheter|The negative pressure suction device to be used in the study will be a Foley catheter. The catheter will be placed through the gastrostomy tube site, directed retrograde through the esophagus, and terminating in the PES.
15936643|NCT03368066|Drug|Cosyntropin|Administer 250mcg cosyntropin to hospitalized cirrhosis patients to assess for the presence of adrenal insufficiency
15936644|NCT03368053|Procedure|Blood sampling|Blood samples will be taken during the single study visit at Year 14 for the assessment of: HIV testing, antibody determination, cell mediated immune (CMI) responses and exploratory characterisation.
15936645|NCT03368040|Device|Tcore|Monitoring system to measure body temperature based on heat-flux technology
15936646|NCT03368027|Behavioral|A cognitive-behavioral intervention program|In this program, participants receive a training of assertive skills, social skills, acceptance, among other psychological aspects.
15936647|NCT03368027|Other|Standard intervention|Participants receive different activities conducted by a psychologist in the association where the attend.
15936649|NCT03368001|Behavioral|SENSE Theatre|SENSE Theatre is a peer-mediated, theatre-based intervention targeting social competence in youth with autism spectrum disorder. The 40 hour intervention is comprised of 10 sessions in which trained typically peers are paired with children with autism spectrum disorder (ASD).
15936650|NCT03368001|Behavioral|Tackling Teenage Together|The Tackling Teenage Together is a psychosocial and sexual education program developed for youth with ASD. It is comprised of 10 sessions.
15936651|NCT03367988|Drug|Opioid Anesthesia|"Doses/concentration of medications/agents used for the anesthetic management of the subjects enrolled in this trial may be adjusted when necessary to provide optimal subject care. Anesthesia will be induced with rocuronium, propofol, intravenous opioids, and other medication(s)/agent(s) at a concentration range/dose(s) based on the clinical need of the subject.
~Depth of anesthesia will be measured with BIS-monitoring and a standard approaching 50% suppression will be maintained throughout the main duration of surgery. Reversal agent will be administered at a post-tetanic count of 1 or 2.
~Anesthesia will be maintained with IV opioids, propofol and/or medication(s)/agent(s), including inhalation anesthetic agents, at a concentration range/dose(s) based on the clinical need of the subject.
~Tracheal extubation will be performed at the end of anesthesia after administration of reversal agent. After extubation, the investigator will determine when the subject is OR discharge ready."
15936652|NCT03367988|Drug|Opioid-free Anesthesia|"Doses/concentration of medications/agents used for the anesthetic management of the subjects enrolled in this trial may be adjusted when necessary to provide optimal subject care. Acetaminophen 1g will be given prior to induction. Anesthesia will be induced with rocuronium 1mg, propofol 3-6 mg/kg, and succinylcholine 1.5 mg/kg Depth of anesthesia will be measured with BIS-monitoring and a standard approaching 50% suppression will be maintained throughout the main duration of surgery. Reversal agent will be administered at a post-tetanic count of 1 or 2.
~Anesthesia will be maintained with Sevoflurane, Magnesium, Lidocaine, Ketamine, Decadron, Ondansetron, and Ketorolac at a concentration range/dose(s) based on the clinical need of the subject.
~Tracheal extubation will be performed at the end of anesthesia after administration of reversal agent. After extubation, the investigator will determine when the subject is OR discharge ready."
15936653|NCT03367975|Other|near infrared spectroscopy|
15936659|NCT03367923|Other|Communication Intervention|Receive email/text
15936666|NCT03367884|Procedure|Neck dissection followed by radiotherapy(50Gy) according to risk factors|Neck dissection followed by radiotherapy(50Gy) according to risk factors
15936667|NCT03367884|Radiation|Definitive radiotherapy|Definitive radiotherapy (70Gy)
15936668|NCT03367871|Drug|Pembrolizumab|IV
15936669|NCT03367871|Drug|Paclitaxel|Administered intravenously (IV) on day 1
15936670|NCT03367871|Drug|Cisplatin|Administered intravenously (IV) on day 1
15936671|NCT03367871|Drug|Carboplatin|Administered intravenously (IV) on day 1
15936672|NCT03367871|Drug|Bevacizumab|Administered intravenously (IV) on day 1
15936673|NCT03367858|Behavioral|Motivational Interviewing (MI)|
15936674|NCT03367858|Behavioral|Brief Adolescent Mindfulness (BAM)|
15936675|NCT03367845|Behavioral|Control|Parents receive 8 phone contacts (1 per week) that do not focus on material in the sensitivity and couples communication intervention.
15936676|NCT03367845|Behavioral|Sensitivity Intervention|4 home visits take place. Mothers and fathers are video recorded with their infant (separately) for approximate 10-15 minutes at the beginning of each visit. The recorded situations are natural (e.g., playing together, bathing the baby, mealtime, etc.) and the family coach (interventionist) is not actively involved in the parent-child interaction. A different theme is covered across the four intervention sessions. For each parent-infant interaction recording, the family coach reviews the recordings between visits and provides feedback to parents in the following intervention session. The exception to this is that video of parent-child interactions during the lab pre-test is used for material at the first home visit. Each session takes approximately 90 minutes. Visits occur over an 8 week period with phone contacts between each session. Because of COVID-19, we now conduct remote visits using Zoom.
15936677|NCT03367845|Behavioral|Couples' Intervention|The psycho-educational inter-parental conflict prevention curriculum is a 4-session program that takes place in the families' homes. Each session lasts approximately 90 minutes and involves discussion and practice of four themes pertinent to improving conflict process, communication, and emotional security in the family: Conflict Overview, Interparental Conflict and Children, Stresses of Parenting, and Emotional Security. The family coach scaffolds and supports the couples' development of constructive conflict behaviors. Visits occur over an 8 week period with phone contacts between each session. Because of COVID-19, we now conduct remote visits using Zoom.
15936678|NCT03367845|Behavioral|Sensitivity and Couples' Intervention|This group receives both the Sensitivity and Couples' Intervention in their home. There are 8 home visits (4 for Sensitivity and 4 for Couples Intervention). Because of COVID-19, we now conduct remote visits using Zoom.
15936684|NCT03367780|Device|PSMA PET/CT-scan|PSMA PET is a new diagnostic instrument which can visualize the presence of vital acinar cells in salivary gland locations throughout the head and neck, with a sensitive and quantitative signal.
15936685|NCT03367754|Other|Placebo|Placebo
15936686|NCT03367754|Drug|Pembrolizumab|Pembrolizumab, 200 mg, or placebo via intravenous (IV) infusion, single dose.
15936689|NCT03367728|Drug|Ropivacaine|TAP and Rectus Sheath Block Injections of Ropivacaine
15936690|NCT03367728|Drug|Normal saline|TAP and Rectus Sheath Block Injections of Normal Saline
15936691|NCT03367715|Drug|Nivolumab|study treatment on Day 1 with one dose of nivolumab 3 mg/kg
15936692|NCT03367715|Drug|Ipilimumab|study treatment on Day 1 with one dose of ipilimumab 1mg/kg
15936693|NCT03367715|Radiation|Radiation Therapy (RT)|total dose of 30 Gy, given in 5 consecutive fractions of 6 Gy each fraction.
15936694|NCT03367702|Radiation|Intensity-Modulated Radiation Therapy (IMRT)|Undergo IMRT
15936695|NCT03367702|Radiation|Stereotactic Body Radiation Therapy (SBRT)|Undergo SBRT
15936696|NCT03367689|Drug|Olaparib|Olaparib 300 mg twice a day (orally) beginning on Day 1 and continuing through Day 28 of every 28-day cycle.
15936697|NCT03367676|Drug|Trastuzumab|Trastuzumab is administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg every 21 days for 4 cycles.
15936698|NCT03367676|Drug|Docetaxel|Docetaxel 100mg/m2，d1，iv，q3w*4
15936767|NCT03367156|Drug|Dexamethasone|Given PO
15936768|NCT03367156|Other|Placebo|Given PO
15936699|NCT03367663|Drug|Prednisone 20 Mg|Each participant will be randomly assigned to one of two treatment groups, low dose of Prednisone 20mg/d (n=10) and high dose of Prednisone 40 mg/d (n=10). During the experimental periods, the subjects will take either one or two 20mg tablet of Prednisone, according to their assigned group. Subjects will be instructed to take the tablets at home in the mornings after a meal each day for 5 consecutive days. At the baseline visit, a medical history will be documented and a physical examination will be performed. Subjects will be asked to come to the research unit on days 1,2,5 after a 14h fasting where two blood samples (5ml each) will be taken, immediately centrifuged, one for biochemical analysis (Lipid profile, Liver function tests, Glucose, Electrolytes and Renal function tests) and the second will be aliquoted, and stored at -20°C until later analyses.
15936700|NCT03367663|Drug|Prednisone 40 Mg|Each participant will be randomly assigned to one of two treatment groups, low dose of Prednisone 20mg/d (n=10) and high dose of Prednisone 40 mg/d (n=10). During the experimental periods, the subjects will take either one or two 20mg tablet of Prednisone, according to their assigned group. Subjects will be instructed to take the tablets at home in the mornings after a meal each day for 5 consecutive days. At the baseline visit, a medical history will be documented and a physical examination will be performed. Subjects will be asked to come to the research unit on days 1,2,5 after a 14h fasting where two blood samples (5ml each) will be taken, immediately centrifuged, one for biochemical analysis (Lipid profile, Liver function tests, Glucose, Electrolytes and Renal function tests) and the second will be aliquoted, and stored at -20°C until later analyses.
15936701|NCT03367650|Dietary Supplement|Blood sample and environmental survey|The intervention corresponds to a 10 ml of Blood sample and an environmental survey.
15936702|NCT03367637|Other|Standard palliative care|Standard care includes regular follow-up phone calls and home visits by the RPCHO staff for all advanced cancer patients at RPCHO, though the timing of these calls is variable and is selected by the discretion of the team. In addition, patients can contact providers on a landline number available during business hours and staffed by an on-call palliative care provider as and when needed. For after-hours emergency assistance, patients have the option of contacting the on-call palliative-care physicians for assistance.
15936703|NCT03367637|Other|Smart Phone based symptom evaluation application|In addition to the standard palliative care currently provided at the RPCHO, patients will receive biweekly reminders to fill out the African Palliative Care Outcomes Scale (APCA POS) on the new smartphone application on their phones. It is a short symptom assessment questionnaire with responses on 5-point severity scale. In addition to bi-weekly frequency, patients can complete the symptom assessment at any time they feel their symptoms are poorly controlled. The team at RPCHO will be able to track all enrolled patients on a desktop dashboard. Any score of 2 or higher will be flagged. The providers at RPCHO will respond to such patients during business hours via call or text and will advise the patients as indicated or triage to a fellow team member.
15936704|NCT03367611|Diagnostic Test|Immunochemical faecal occult blood test (iFOBT)|All participants in the study will collect a single faecal sample for haemoglobin measurement.
15936705|NCT03367598|Genetic|rs662799 (APOA5 -1131T>C)|Among the 349 normal-weight individuals, 168 were homozygous (TT) for the T allele, 155 were heterozygous for the C allele (TC) and 26 were homozygous (CC) for the C allele of the APOA5 -1131T>C polymorphism. Among the 154 overweight individuals, 68 were homozygous (TT) for the T allele, 75 were heterozygous for the C allele (TC) and 11 were homozygous (CC) for the C allele of the APOA5 -1131T>C polymorphism.
15936706|NCT03367585|Dietary Supplement|Physical exercise + Vitamin D3|Strength exercise + Supplementation of vitamin D3 50,000 IU / week
15936707|NCT03367585|Other|Physical exercise|Strength exercise
15936708|NCT03367572|Drug|Dexamethasone|Given PO
15936709|NCT03367572|Other|Laboratory Biomarker Analysis|Correlative studies
15936710|NCT03367572|Drug|Netupitant/Palonosetron Hydrochloride|Given PO
15936711|NCT03367572|Drug|Olanzapine|Given PO
15936712|NCT03367572|Other|Placebo|Given PO
15936713|NCT03367572|Drug|Prochlorperazine|Given PO
15936714|NCT03367572|Other|Quality-of-Life Assessment|Ancillary studies
15936715|NCT03367559|Biological|ROTAVAC®|Rotavac® is in frozen form and is thawed till fully liquid prior to administration.
15936716|NCT03367546|Procedure|Blood and Marrow Transplant|Reduced intensity conditioning (RIC) with rabbit ATG, fludarabine, cyclophosphamide, thiotepa and low dose (2 Gy) total body irradiation followed by T-cell replete, unmanipulated, haploidentical related donor stem cell transplant (HaploHCT) and post-transplant cyclophosphamide (PTCy)
15936717|NCT03367533|Drug|Ketamine|Intravenous ketamine
15936718|NCT03367533|Drug|Perampanel|Oral perampanel (6 mg)
15936719|NCT03367533|Drug|Placebo|Oral placebo
15936720|NCT03367520|Behavioral|StayQuit|StayQuit offers 3 meetings during hospitalization and up 13 telephone calls. StayQuit begins in the hospital with an assessment of motivation to remain quit after discharge and a brief intervention to develop discrepancy between values and behaviors and generate change talk. Participants are also encouraged to try nicotine replacement therapy during the hospitalization and after discharge. Telephone counseling is brief and focused on managing withdrawal from nicotine, coping with cravings, and supporting use of NRT. The investigators will work with hospital staff as needed to ensure that nicotine replacement therapy is offered to participants during the inpatient stay and prescribed at discharge.
15936721|NCT03367507|Behavioral|Sub-symptom aerobic exercise|Both groups will be instructed to perform their respective aerobic exercise program the following day after completing their first treadmill test. Participants will be instructed to exercise at their prescribed intensity for a maximum of 30 minutes a day, 4-5 days a week. They will be asked to postpone the exercise until the next day if they experience significant increases in symptoms from usual resting levels. Exercise type will be the participant's choice, however we will ask the participant refrain from contact/high risk activities including any modalities that might induce rapid and aggressive head movements.
15936722|NCT03367494|Diagnostic Test|Measurement of Sweat Chloride and Sweat Bromide|Sweat Chloride comparisons between ion exchange chromatography and fluorescence citrate-based sensors
15936723|NCT03367481|Device|Toothbrush type|In this cross-over study, the participants will use either a soft brush (control) and the medium brush (test).
15936724|NCT03367468|Other|Exercise|Strengthening exercises ( extrinsic and intrinsic foot muscles) Stretcthing exercises (plantar fascia, plantar flexor muscles)
15936725|NCT03367468|Other|Mobilization|Antero-posterior gliding, talocrural traction, metatarsal mobilization
15936726|NCT03367442|Other|no intervention|no intervention
15936728|NCT03367416|Behavioral|NIATx model|"The NIATx model engages organizations through a multi-clinic learning collaborative and coaching. NIATx teaches organizations how to implement change by using their own organization as the teaching mechanism. Key components of the model include:
~educating executives on how to promote effective process change techniques
~training staff teams in the theory and practice of organizational change techniques
~training staff to develop and implement a process improvement intervention
~implementing a sustainability plan to institutionalize change and avoid reverting to previous methods"
15936729|NCT03367403|Drug|LY3002813|Administered IV
15936730|NCT03367403|Drug|Placebo|Administered IV
15936731|NCT03367390|Device|AID System|AID system
15936732|NCT03367390|Drug|Insulin Lispro|Individualized doses of insulin lispro administered via the AID system to maintain glycemic control, except during procedures designed to induce hyperglycemia and hypoglycemia.
15936733|NCT03367377|Drug|LY3209590|Administered SC
15936734|NCT03367377|Drug|Insulin Glargine|Administered SC
15936735|NCT03367364|Behavioral|Patient education bundle (PEB),|A charge nurse will intervene in real-time via an EHR-triggered alert when there is documentation that a dose of VTE prophylaxis medication is not given for any reason. The charge nurse will speak to the bedside nurse and one of them will provide the patient with the education bundle including one-on-one personalized discussion, supplemented by a 2-page paper handout and patient education video.
15936736|NCT03367364|Behavioral|Nurse feedback and coaching (NFC)|Nurse leadership (i.e. managers, directors) will provide data to all nurses on their personal clinical effectiveness with the proportion of doses of VTE prophylaxis administered. The data will have comparisons to their nurse peers on the same floor. Coaching for nurses will include one-on-one conversations with bedside nurses with lower performance than their peers.
15936737|NCT03367351|Behavioral|Web-Based Education|Completion of a CGM specific web-based educational intervention that includes a series of online learning modules.
15936738|NCT03367351|Behavioral|Social Support|Engagement in peer-led CGM specific discussion boards
15936739|NCT03367351|Behavioral|Standard of Care|Standard of Care - serves as the control group for the treatment arm
15936740|NCT03367338|Other|Low-phosphate diet|Very low-phosphate diet, PPR value of 8 mg/g, vs. low-phosphate diet, PPR value of 10 mg/g
15936741|NCT03367325|Device|CDS-NVAF|The CDS-NVAF is intended for patients diagnosed with NVAF and treated with VKA. This tool calculates the time in the therapeutic range (TTR) using the Rosendaal method considering the last International Normalized Ratio (INR) data. The INR data are found in the clinical history of NVAF patients. The CDS-NVAF will be activated when the physician introduces the last INR value. At this time the TTR will be calculated automatically. If the TTR value is < 65%, a pop up screen with a warning text will open suggesting a change to DOAC therapy. The physician can decide whether to change or not the previous prescription. If the TTR value in > 65% the pop up screen will not appear. The TTR value will remain registered on the screen of the follow up of oral anticoagulant use and can be consulted in future queries. The diffusion of the CDS-NVAF will be made by an announcement on the first day of the intervention when the health care professional opens the electronic clinical history.
15936742|NCT03367312|Drug|Hyperpolarized 129Xenon gas|Hyperpolarized 129Xenon gas XeMRI scans will provide 3D images of ventilation and gas exchange pre, post, and 2-4 hours post inhaled prostacyclin treatment. Subjects will inhale HP 129Xe from the dose delivery bags with each scan and then move into the scanner and undergo basic 1H localizer and anatomical scans. Once localization is complete, subjects will undergo several MRI scans after inhalation of HPXe. This will occur as three scans at the three different time points (pre, post, and 2-4 hours post) of inhaled prostacyclin treatment.
15936743|NCT03367299|Drug|Chemotherapy + Blinatumomab|Chemotherapy cycles are administered at 21-28 days intervals and each blinatumomab course is 28-day long.
15936744|NCT03367286|Other|inspection mode|different inspection modes：Computed Tomography Perfusion (CTP) or Magnetic Resonance Perfusion (MRP)
15936745|NCT03367273|Other|skin biopsy|Lesional skin biopsy was taken from every patient. Also a skin biopsy was taken from every control subject
15936746|NCT03367260|Other|Preference Elicitation|Survey of patient preferences for treatment
15936747|NCT03367247|Behavioral|BOLSTER|BOLSTER provides patients and caregivers with education and skills training, symptom management, and support across care settings over a four-week period.
15936748|NCT03367247|Other|Enhanced Discharge Planning (EDP)|EDP provides patients and caregivers a single session of education and skills training, symptom management, and support.
15936749|NCT03367234|Behavioral|Individual Therapy Sessions|One-on-one sessions with a counselor
15936750|NCT03367234|Behavioral|Cognitive Behavioral Therapy (CBT)|Cognitive Behavioral Therapy techniques delivered by a behavioral health consultant (BHC)
15936751|NCT03367234|Behavioral|Medication-Assisted Treatment|Buprenorphine or Extended-Release Naltrexone
15936752|NCT03367234|Behavioral|Peer Recovery Specialist Support|Individual and/or group sessions with a certified peer recovery specialist
15936753|NCT03367234|Behavioral|Group Therapy Sessions|Group therapy sessions
15936754|NCT03367234|Behavioral|Psychiatric Consultation|Access to psychiatric consultation
15936755|NCT03367234|Behavioral|Contingency Management|Rewards for engagement in specified recovery behaviors
15936756|NCT03367221|Device|NAVA ventilation|Assisted Ventilation Mode, synchronized, through EAdi catheter, with patient's inspiratory effort and proportional to respiratory drive
15936757|NCT03367195|Drug|Omeprazole|1 Omeprazole 20 mg capsules twice daily
15936758|NCT03367195|Drug|DLBS2411|1 DLBS2411 caplet 250 mg, twice daily
15936759|NCT03367195|Drug|Placebo capsule of Omeprazole|1 placebo capsule of omeprazole, twice daily
15936760|NCT03367195|Drug|Placebo caplet of DLBS2411|1 placebo caplet of DLBS2411, twice daily
15936761|NCT03367182|Drug|Weekly paclitaxel|Drug: paclitaxel 80mg/m2 iv on days 1, 8, 15 and 22 of each 4-week cycle
15936762|NCT03367182|Drug|Topotecan|Drug: topotecan 4mg/m2 iv on days 1, 8 and 15 of each 4-week cycle, or 1.25 mg/kg on days 1-5 of each 3-week cycle
15936763|NCT03367182|Drug|Pegylated liposomal doxorubicin|Drug: liposomal doxorubicin 40mg/m2 iv every 4 weeks
15936764|NCT03367182|Drug|Bevacizumab|Drug: bevacizumab [Avastin] 10m/kg iv every 2 weeks or 15mg/kg iv every 3 weeks
15936765|NCT03367169|Procedure|minimally invasive method|type of surgical technique
15936766|NCT03367169|Procedure|open reduction method|type of surgical technique
15936774|NCT03367130|Behavioral|Mobile phone reminder|Intervention described already in arm/group descriptions.
15936775|NCT03367104|Device|ECG Belt|Assess electrical dyssynchrony with an anterior-posterior body surface mapping system.
15936776|NCT03367091|Other|Ekso GT gait training with high swing assistance|"Participant will walk for 20-minutes in the Ekso GT SmartAssist with the swing assistance set at high assistance"
15936777|NCT03367091|Other|Ekso GT gait training with neutral swing assistance|"Participant will walk for 20-minutes in the Ekso GT SmartAssist with the swing assistance set at neutral"
15936778|NCT03367091|Other|Ekso GT gait training with high swing resistance|"Participant will walk for 20-minutes in the Ekso GT SmartAssist with the swing assistance set at high resistance"
15936779|NCT03367078|Device|Anodal tDCS|Anodal tDCS, on L-DLPFC area, is started 2 weeks after admission to the sABI Operative Unit with: one session per day (in the morning), possibly for 5 consecutive days per week (from Monday to Friday), for 2 consecutive weeks. Each tDCS session lasts 20 minutes. Current intensity is 1 mA during the first week, 2 mA in the second week
15936780|NCT03367078|Other|Usual care|Usual care of DOC patients
15936781|NCT03367065|Radiation|Dynamic contrast enhanced computerised tomography|
15936782|NCT03367052|Procedure|Two level Prodisc-C vivo|Two level of Prodisc-C vivo artificial disc replacement will be done in one group of patients.
15936783|NCT03367052|Procedure|Hybrid|The hybrid method will be used in one group of patients.
15936784|NCT03367039|Procedure|ProDisc-C vivo|Total Disc Replacement using ProDisc-C vivo.
15936785|NCT03367039|Procedure|Anterior cervical discectomy fusion|Anterior Cervical Discectomy and Fusion
15936786|NCT03367026|Drug|Ivabradine Oral Product|"Patients in the ivabradine treatment arm receive an additional enteral preparation (orally, via nasogastric tube or Jejunum tube) of ivabradine for 4 days.
~Day 1 :
~2.5 mg ivabradine b.i.d. if heart rate ≥90 bpm
~Day 2,3,4:
~2.5 mg ivabradine b.i.d. if 60bpm≥heart rate<90bpm. 5.0mg ivabradine b.i.d. if heart rate ≥90bpm"
15936787|NCT03367013|Dietary Supplement|Bovine Lactoferrin|Intervention includes a daily dose of 200 mg/kg bovine lactoferrin in breast/donor human milk or formula milk until 34 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer, or until discharge home or transfer, if earlier.
15936788|NCT03367013|Other|No Bovine Lactoferrin added|Control includes daily study feed with no bovine lactoferrin added in breast/donor human milk or formula milk until 34 weeks corrected gestation or for a minimum of 2 weeks, whichever is longer, or until discharge home or transfer, if earlier.
15936789|NCT03367000|Dietary Supplement|Ceprolac|The supplement was packed into two ~15g sachets in powder form of a 90-94% whey protein isolate and hydrolysed whey. The protein powder was dissolved in 75-100ml water at room temperature and was ingested post meal once daily.
15936790|NCT03367000|Other|Dietary counseling (DC)|Received standard dietary counseling at baseline and month 6.
15936791|NCT03366974|Drug|Midazolam|5 mg PO, 1 mg IV
15936792|NCT03366974|Drug|Clarithromycin|500 mg bid
15936793|NCT03366974|Dietary Supplement|Grapefruit juice|500 mL
15936794|NCT03366961|Procedure|Conversion surgery|Palliative chemotherapy followed by radical gastrectomy
15936795|NCT03366948|Other|IGDT-10 self-administered questionnaire|"Patients and their parents will answer the French version of the IGDT-10 self-administered questionnaire (IGDT-10-P in the parents 'questionnaire).
~The IGDT-10 is a self-administered questionnaire based on DSM-5 internet gaming disorder criteria and the IGDT-10-P is a parental version specially adapted from the IGDT-10 for this study."
15936796|NCT03366935|Other|EPL and CEI|"Procedure: Standard epidural placement(EPL)
~Drug: ropivacaine Drug: sufentani 0.1% ropivacaine + sufentanil 0.3μg/mL
~Device: Infusion pump Infusion pump set to continuous epidural infusion(CEI) plus patient-controlled epidural analgesia (PCEA)."
15936797|NCT03366935|Other|DPE and CEI|"Procedure: Dural puncture epidural (DPE) Epidural with spinal needle placed to create a single dural puncture and confirm free flow of cerebral spinal fluid (CSF) , without direct medication administration into the subarachnoid space.
~Drug: ropivacaine Drug: sufentani 0.1% ropivacaine + sufentanil 0.3μg/mL
~Device: Infusion pump Infusion pump set to continuous epidural infusion(CEI) plus patient-controlled epidural analgesia (PCEA)."
15936798|NCT03366935|Other|DPE and PIEB|"Procedure: Dural puncture epidural (DPE) Epidural with spinal needle placed to create a single dural puncture and confirm free flow of cerebral spinal fluid (CSF) , without direct medication administration into the subarachnoid space.
~Drug: ropivacaine Drug: sufentani 0.1% ropivacaine + sufentanil 0.3μg/mL
~Device: Infusion pump Infusion pump set to programmed intermittent epidural boluses (PIEB) plus patient-controlled epidural analgesia (PCEA)."
15936799|NCT03366922|Dietary Supplement|Artemisia Annua, Moringa oleifera|As described above
15936800|NCT03366909|Behavioral|Mindfulness based relapse prevention (MBRP)|"These weekly visits include a Mindfulness Meditation session:
~The sessions of meditation take place in a dedicated room. The collective sessions owed approximately of 2 hours and will approach the following themes: (1) Autopilot, (2) Facing obstacles, (3) Full awareness of breath, (4) Staying present, (5) Allow, let go (6) Thoughts are not facts, (7) How to take care of oneself, (8) Mindfulness on a daily basis."
15936801|NCT03366909|Behavioral|classic therapy|These weekly visits include usual addiction care provided during a consultation. This care includes psychotherapeutic management: brief interventions, cognitive-behavioral therapies, motivational interviews; associated with nonsystematic pharmacological management.
15936802|NCT03366896|Diagnostic Test|Malay 3D-CAM diagnostic tool 1|Assessor 1 uses Malay 3D-CAM to detect Delirium
15936803|NCT03366896|Diagnostic Test|Malay 3D-CAM Diagnostic tool 2|Assessor 2 uses Malay 3D-CAM to detect Delirium
15936804|NCT03366883|Combination Product|Paclitaxel, Cisplatin Plus 5-FU (TCF)|preoperative chemotherapy with three cycles of TCF(Paclitaxel 135mg/m2 D1;Cisplatin 60mg/m2 D1 or 20mg/m2 D1-D3;5-fluorouracil 600mg/m2 D1-D5；repeated every 3 weeks)
15936805|NCT03366883|Radiation|radiochemotherapy|preoperative radiochemotherapy (41.4 Gy/23 fractions or 40 Gy/20 fractions) with four cycles of TP(Paclitaxel 45mg/m2 on D1 and Cisplatin 20mg/m2 D1,repeated every week)
15936806|NCT03366870|Behavioral|Computerized Cognitive Behavioral Therapy for Insomnia|A computerized insomnia intervention that employs the same behavioral, educational, and cognitive treatment components that underlie non-computerized CBT-I.
15936807|NCT03366870|Behavioral|Sleep Education|A web-based program will deliver components of sleep education via an Internet platform.
15936808|NCT03366857|Drug|Oxygen 30 %|The oxygen concentration will be set at 30%.
15936809|NCT03366857|Drug|Oxygen 80 %|The oxygen concentration will be set at 80%.
15936812|NCT03366831|Behavioral|Thirty Million Words Initiative Newborn Intervention|The Thirty Million Words Initiative Newborn Intervention (TMW-Newborn) is a public health effort aimed at increasing awareness about the importance of a child's early language environment in his or her first years of life. This one-time educational intervention will be impacting maternal awareness and knowledge about the importance of children's early language environment, between ages 0 and 3.
15936813|NCT03366818|Device|thrombectomy|mechanical thrombectomy
15936814|NCT03366805|Behavioral|Pain Management Patient Education Video|Patient education video that were created in-house specifically for this project.
15936815|NCT03366805|Behavioral|Wound Care Patient Education Video|Patient education video that were created in-house specifically for this project.
15936816|NCT03366792|Device|Artemis™ software system|Computerized targeting of mpMRI lesions. The computerized co-registration will then be performed by software within the Artemis™ system and will fuse the MR imaging with real-time ultrasound imaging.
15936817|NCT03366779|Device|6mm annular closure device|6MM Barricaid annular closure device implantation following standard lumbar discectomy
15936818|NCT03366766|Biological|Nivolumab|Given IV
15936819|NCT03366766|Drug|Cisplatin|Given IV
15936820|NCT03366766|Drug|Pemetrexed Disodium|Given IV
15936821|NCT03366766|Drug|Gemcitabine Hydrochloride|Given IV
15936822|NCT03366753|Procedure|acute normovolemic hemodilution|acute normovolemic hemodilution (ANH) is performed by using 5 ml/kg of blood salvage and intravenously administering 5 ml/kg of balanced hydroxyethystarch 130/0.42 (Tetraspan™) for 15 min
15936823|NCT03366753|Procedure|In-vitro hemodilution|Blood sample after ANH 5 ml/kg undergoes further 30% in-vitro dilution by adding 1-1.5 ml hydroxyethystarch 130/0.42
15936824|NCT03366740|Other|GB mixed full strength rice suji|On day 4 (3 days after milk suji) after diagnosis of PD, if PD doesn't resolve, the child will be enrolled in the study and after randomization will get the Green banana mixed full strength rice suji The diet will be continued for 7 days and a child will be followed. If there is deterioration of diarrhea (either increased frequency or watery consistency) for 3 days or condition remains static up to 7 days the child will be declared as treatment failure.
15936825|NCT03366740|Other|Full strength rice suji Alone|"On day 4 (3 days after milk suji) after diagnosis of PD, if PD doesn't resolve, the child will be enrolled in the study and after randomization will get full strength rice suji alone.
~The diet will be continued for 7 days and a child will be followed. If there is deterioration of diarrhea (either increased frequency or watery consistency) for 3 days or condition remains static up to 7 days the child will be declared as treatment failure."
15936826|NCT03366740|Other|3/4th strength rice suji|"On day 4 (3 days after milk suji) after diagnosis of PD, if PD doesn't resolve, the child will be enrolled in the study and after randomization will get 3/4th strength rice suji.
~The diet will be continued for 7 days and a child will be followed. If there is deterioration of diarrhea (either increased frequency or watery consistency) for 3 days or condition remains static up to 7 days the child will be declared as treatment failure."
15936827|NCT03366727|Device|drug-coated balloon catheter （Orchid, Acotec）|After predilation, using drug-coated balloon catheter to cover the whole treated segment
15936828|NCT03366727|Device|plain balloon catheter (Admiral, medtronic)|After predilation, using plain balloon catheter to cover the whole treated segment
15936829|NCT03366714|Device|nasal CPAP support with RAM cannula|Patients with respiratory distress syndrome who do not need intubation in the delivery room. This groub will be provided with non-invasive respiratory support RAM cannula.
15936830|NCT03366714|Device|nasal CPAP support with Hudson cannula|Patients with respiratory distress syndrome who do not need intubation in the delivery room. This groub will be provided with non-invasive respiratory support Hudson cannula.
15936831|NCT03366701|Other|Rehabilitation|The intervention (routine care) correspond to five weeks rehabilitation program
15936832|NCT03366688|Drug|IBI306|Cohort 1: 25 mg Subcutaneous(SC) (this cohort is open label without placebo); Cohort 2: 75 mg SC; Cohort 3: 150 mg SC; Cohort 4: 75 mg IV; Cohort 5: 300 mg SC; Cohort 6: 450 mg SC; Cohort 7: 600 mg SC; Cohort 8: 450 mg IV.
15936833|NCT03366688|Drug|placebo|Cohort 2: 75 mg SC; Cohort 3: 150 mg SC; Cohort 4: 75 mg IV; Cohort 5: 300 mg SC; Cohort 6: 450 mg SC; Cohort 7: 600 mg SC; Cohort 8: 450 mg IV.
15936834|NCT03366675|Drug|AZD2811|AZD2811 100mg/vial
15936835|NCT03366662|Device|Monitoring of frontal electrical muscle activity|Continuous monitoring of frontal electrical muscle activity during general anesthesia simultaneous to burst suppression electroencephalogram
15936836|NCT03366649|Procedure|Undersizing Mitral Annuloplasty|Participants will receive a commercially available annuloplasty ring. 10-12 ethicon sutures are placed around the mitral annulus, and the metallic ring is then implanted onto the mitral annulus to reduce it in size. To ensure uniformity between patients, an Edwards Lifesciences Physio II ring will be used in all patients, with a ring size ranging between 26mm-30mm.
15936837|NCT03366649|Procedure|Papillary Muscle Approximation|One or two 4-0 pledgeted sutures are used to draw the two papillary muscle tips together to reduce the inter papillary muscle separation (IPMS) before undergoing undersizing mitral annuloplasty.
15936838|NCT03366636|Behavioral|Project Legacy|"Project Legacy - Project Legacy is a 5-week, twice a week, 10 sessions small group intervention that encourages homeless and at-risk of homeless youth ages 14-19 to imagine a positive future and discuss how current risk behaviors can be a barrier to a successful adulthood. The program includes thinking about the future, the importance of positive social supports, short and long-term goal planning, and decision making. The program also includes life skills building, addressing past and current risk behaviors, linking to resources and navigating service systems, information on contraception and condoms, a healthy life plan and self-sufficiency. The 5 content core elements are the following:
~1. Thinking about the future
~2. Present actions to achieve future success
~3. Safeguarding one's future
~4. Creating a Healthy Life Plan
~5. Navigating service systems"
15936839|NCT03366623|Behavioral|Hospital clown|Presence of the hospital clown
15936840|NCT03366623|Behavioral|No hospital clown intervention|Presence of pediatric nurses and biomedical laboratory technologists in the venipuncture procedure.
15936841|NCT03366610|Other|Non-interventional|Non-interventional
15936842|NCT03366597|Drug|Sevoflurane|1.5%-3% Sevoflurane will be given during the cardiac surgery except cardiopulmonary bypass.
15936843|NCT03366584|Dietary Supplement|Beta carotene|Beta carotene 25,000 IU
15936844|NCT03366584|Dietary Supplement|Vitamin D3|Vitamin D3 50,000 IU
15936845|NCT03366584|Dietary Supplement|Zinc|Zinc 50 mg
15936846|NCT03366584|Drug|Dexamethasone|Dexamethasone 6 mg
15936847|NCT03366571|Drug|Nucleos(t)ide Analogues|Entecavir 0.5mg daily, Lamivudine100mg qd daily, Adefovir Dipivoxil 10mg daily, telbivudine 600mg qd daily, their combination therapy, tenofovir 300mg qd daily.
15936848|NCT03366558|Diagnostic Test|UPDRS questionnaires|UPDRS (Unified Parkinson's Disease Rating Scale) questionnaires are utilized for the assessment of the disease stage.
15936849|NCT03366558|Diagnostic Test|20-step walking test|20-step walking test is utilized either for assessing the disease stage (subjects having Parkinson disease) or for assessing the normal walking (subjects not having Parkinson disease)
15936851|NCT03366532|Other|Dietary assessments|We use food frequency questionnaires to collect and update intake of foods and nutrients in observational studies. No intervention is involved.
15936852|NCT03366519|Procedure|clinical echography (CE)|clinical echography (CE) is performed in the first 24 hours following the diagnosis of PE, in emergency unit
15936853|NCT03366506|Other|Observation|
15936854|NCT03366493|Combination Product|FRD|The Folate Receptor-Mediated Staining Solution is a dye solution that stains for medical purposes used in staining cells and tissues for detecting neoplastic diseases. After inserting a speculum into your vagina, the FRD™ staining solution will be applied to the cervix using an applicator. After removal of the applicator, the doctor will inspect the applicator for color changes and note any changes. The physician will then remove any excess stain from the cervix using distilled water.
15936855|NCT03366493|Other|Cytology|Cytology testing done by collecting samples of cells, and smearing those samples across a glass microscope slide in order to detect abnormal cells that may develop into cervical cancer.
15936856|NCT03366493|Other|HPV testing|HPV tests will detect HPV infections, which can lead to cervical cells to become cancer cells.
15936857|NCT03366493|Procedure|Colposcopy|During the colposcopic examination, the physician will insert a speculum into the vagina and then apply a vinegar solution to the cervix. The vinegar solution causes any potential abnormal cells to turn white. These white regions are best seen using the colposcope, which magnifiesthe skin.
15936858|NCT03366493|Procedure|ECC|If the examination is not satisfactory and the doctor is not able to see the entire cervix, he may perform an endocervical curettage, or ECC. This sample is collected by placing a long, thin instrument into the cervical canal and a sample is scraped from that area. The sample will be sent to the laboratory for a pathologist to review.
15936859|NCT03366493|Procedure|Biospy|"According to the colposcopy assessment, if the doctor sees a white area, or an area of abnormal cells, a tiny sample of tissue, called a biopsy will be taken from the cervix. About half of women do not feel the biopsy being taken.
~Others may feel a quick pinch. After the biopsy, the wound will be treated to stop bleeding.The biopsy will be sent to the laboratory for a pathologist to review."
15936860|NCT03366480|Drug|ABTL0812 in combination with paclitaxel and carboplatin|ABTL0812 in combination with paclitaxel and carboplatin.
15936861|NCT03366467|Other|SADE|The SADE: the sensory stimuli addressed are visual and auditory, as follows: (i) Visual sensation. All ceiling fluorescent lighting are removed. The adapted lighting consisted of slow-moving, repetitive visual color effects created by a projector, in the child's visual field. (ii) Auditory stimuli include rhythmic music, which was heard via loudspeakers.
15936862|NCT03366467|Other|RDE|The RDE utilized fluorescent lighting on the ceiling, without special visual effects and without music stimulation.
15936863|NCT03366441|Other|Telephone call|From 20 October to 10 November 2016, telephone calls were given to the donors in the phone call group
15936864|NCT03366441|Other|SMS|Text messages were sent to an equal number of donors in the SMS group
15936865|NCT03366428|Drug|DS-8201a|DS-8201a is supplied as a lyophilized powder which is reconstituted for infusion
15936866|NCT03366415|Drug|gemcitabine and cisplatin (Induction and adjuvant chemotherapy)|Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (25mg/m² d1-3) every 3 weeks for 2 cycles before IMRT and after IMRT.
15936867|NCT03366415|Radiation|IMRT|Intensity modulated-radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4 Gy to the primary tumor
15936868|NCT03366415|Drug|gemcitabine and cisplatin (Induction chemotherapy)|Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (25mg/m² d1-3) every 3 weeks for 2 cycles before concurrent chemoradiotherapy.
15936869|NCT03366415|Radiation|IMRT and concurrent cisplatin|Intensity modulated-radiotherapy (IMRT) is given as 2.2 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 or 70.4Gy to the primary tumor, concurrently with cisplatin 30mg/m² every week.
15936870|NCT03366402|Diagnostic Test|RT-PCR H1N1|At the first stage an upper respiratory swab was taken to determine the presence of Infuenza A H1N1 (the virus identification was done by RT - PCR). Then the different subtypes of lymphocytes were quantified at different stages of the disease. The identification and quantification of the different cell types were performed by FACS method, the cell receptors that were marked were CD31, CD19, CD4, CD3, CD45, CD8, CD56.
15936871|NCT03366376|Radiation|WBRT with hippocampus-sparing and SIB|"Radiotherapy could be delivered in 5, 8, or 10 fractions according to participating investigator's choice. The prescribed doses are as below;
~Fractions 5fxs 8fxs 10fxs Whole brain 20 Gy 24 Gy 25 Gy Gross tumor 30 Gy 40 Gy 40 Gy"
15936872|NCT03366363|Other|acupuncture|acupuncture is a therapy of traditional Chinese medicine，in which acupuncturist puncture the patient's skin at specific acupoints with needle.
15936873|NCT03366350|Procedure|Allogeneic hematological stem cell transplantation|Patients receive allogeneic hematological stem cell transplantation after they achieve MRD- CR through CAR-T therapy.
15936874|NCT03366337|Drug|Bardoxolone methyl capsules|Bardoxolone 5 mg capsules
15936875|NCT03366324|Genetic|Second generation CAR-T cells|Patients receive CD19 CAR-T cells transduced with a lentiviral vector on days 0, 1, and 2.
15936876|NCT03366324|Procedure|Hematological stem cell transplantation|Patients receive hematological stem cell transplantations within 3 months after they achieve MRD- remissions after CAR-T therapies.
15936877|NCT03366311|Procedure|holding position|two types of holding positions plus two types of shapes of stylet, with or without epiglottis lift
15936878|NCT03366298|Combination Product|Epipen 0.3mg|Epipen 0.3mg auto-injector
15936879|NCT03366298|Combination Product|Emerade 300mcg|Emerade 300mcg auto-injector
15936880|NCT03366298|Combination Product|Emerade 500mcg|Emerade 500mcg auto-injector
15936881|NCT03366285|Diagnostic Test|Attachment story completion taks (ASCT)|Bonding quality
15936882|NCT03366272|Drug|Nivolumab|eight cycles of nivolumab (3 mg/kg) plus (R)-GemOx in 2-wk intervals followed by additional 18 infusions of Nivolumab (3 mg/kg) in 2-wk intervals as consolidation or up to progression or unacceptable toxicity, whatever occurs first
15936883|NCT03366272|Drug|Rituximab|eight cycles of R-GemOx in 2-wk intervals
15936884|NCT03366272|Drug|Gemcitabine|eight cycles of (R)-GemOx in 2-wk intervals
15936885|NCT03366272|Device|Oxaliplatin|eight cycles of (R)-GemOx in 2-wk intervals
15936886|NCT03366259|Drug|Misoprostol 200Mcg Tab|administration of 200 Mcg of misoprotol rectal
15936887|NCT03366259|Procedure|elective cesarean section|elective cesarean section for full term patients
15936888|NCT03366246|Drug|Lidocaine / Prilocaine Cream|according randomized this side received placebo or active product
15936889|NCT03366246|Drug|placebo|according randomized this side received placebo or active product
15936890|NCT03366233|Other|Mental fatigue|A modified Stroop task of 90 min, partitioned in 8 blocks of 252 stimuli, will be used as mentally fatiguing task. The Stroop task requires inhibition and sustained attention on controlled processes.
15936891|NCT03366233|Other|Control|In the control task subjects will have to watch a documentary on the same computer screen as that used for the experimental trial. These documentaries are chosen based on their emotionally neutral, yet engaging content.
15936892|NCT03366220|Drug|Plasma|Initial resuscitation with plasma will be 10 mL/kg (700 mL in a typical 70 kg adult). Traditional doses of plasma, when used to correct coagulopathy range from 10-15 mL/kg.23 The plasma will be administered at a rate of 2-3 mL/kg/hr (140-210 mL/hr in a typical 70 kg adult). A research physician will be at bedside to follow patient resuscitation. Plasma administration may be terminated before the entire dose is administered if patients show clinical improvement. After the initial dose of plasma has been given, subsequent resuscitation will follow usual care using balanced crystalloids.
15936893|NCT03366220|Drug|Balanced crystalloids|Usual care using balanced crystalloids (Iso-Lyte or Plasma-Lyte) only will follow Surviving Sepsis Campaign guidelines. Controls will receive 30 mL/kg (2100 mL in a typical 70 kg adult) of crystalloids within the first 3 hours. Subsequent resuscitation with balanced crystalloids will be titrated to the endpoints of resuscitation.
15936894|NCT03366207|Drug|Ciprofloxacin|Ciprofloxacin 250 mg PO twice daily (BID) x 3 days for women with uUTI.
15936895|NCT03366181|Device|internal cardioverter defibrillator implant (ICD)|to implant ICD in failing heart subjects with reduced left ventricle ejection fraction (LVEF < 35%).
15936896|NCT03366181|Procedure|percutaneous catheter ablation|to perform catheter ablation in patients with heart failure and reduced left ventricle ejection fraction (LVEF < 35%).
15936897|NCT03366155|Device|OneRNA|genomic test done on tumor and normal liver biopsy samples taken during baseline and end of treatment
15936898|NCT03366155|Drug|Panitumumab|6 mg/kg, IV
15936899|NCT03366155|Drug|FUDR-Dex|HAIP will be filled with mixture of Floxuridine and Dexamethasone. Pump will perfuse drugs to liver for 14 days. Floxuridine (0.12 mg/kg X pump volume X pump flow rate), Dexamethasone (1 mg/day X pump volume (30) X pump flow rate)
15936900|NCT03366155|Drug|Oxaliplatin|85 mg/m2, IV
15936901|NCT03366155|Drug|5FU|2000 mg/m2, IV 46-hour infusion of 5-Fluorouracil + 400 mg/m2, IV of Leucovorin
15936902|NCT03366155|Drug|Irinotecan|150 mg/m2, IV
15936903|NCT03366155|Procedure|HAIP installation|HAIP pump installation
15936904|NCT03366155|Drug|cetuximab|500 mg/m2, IV
15936905|NCT03366155|Device|Medtronic SynchroMed II Pump with Codman 3000 Constant Flow Pump Catheter|implanted Medtronic SynchroMed II Pump with Codman 3000 Constant Flow Pump Catheter
15936906|NCT03366142|Drug|Ustekinumab|0.75 mg/kg or 45 or 90 mg via subcutaneous injection for 5 doses (second dose 4 weeks after first, subsequent doses every 12 weeks thereafter).
15936907|NCT03366116|Drug|aza-TdC|Methylation-mediated silencing of genes is an epigenetic mechanism implicated in carcinogenesis; agents that inhibit this mechanism are of clinical interest because of their potential to re-activate silenced tumor suppressor genes. The nucleoside analog 5-aza-4'-thio-2'- deoxycytidine (Aza-TdC) is incorporated into DNA, where it engages the active site of DNA methyltransferase I (DNMT1), a maintenance methyltransferase that contributes to hypermethylation and silencing of tumor suppressor genes. Aza-TdC offers an improvement over traditional DNMT inhibitors via higher incorporation into DNA and lower cytotoxicity; Aza-TdC has greater antitumor activity than another recently developed DNMT1 inhibitor, TdCyd, in some solid tumor xenograft models. Treatment with Aza-TdC is anticipated to yield inhibition of tumor growth due to DNMT1 depletion at oral doses that are well tolerated in extended dosing schedules.
15936908|NCT03366103|Biological|Navitoclax|Given PO
15936909|NCT03366103|Drug|Vistusertib|Given PO
15936910|NCT03366090|Procedure|Biopsies during coloscopy|During standard ileocolonoscopy intestinal biopsy specimens of the macroscopically most inflamed ileal and colonic mucosa will be obtained at the moment of presentation and during follow up.
15936911|NCT03366077|Dietary Supplement|Probiotic|Probiotic
15936912|NCT03366064|Biological|Pemetrexed and donor-derived NK cell infusion|Patients are administered with donor-derived NK cells one week after pemetrexed infusion
15936913|NCT03366051|Procedure|Sentinel Node Mapping|At least one sentinel node should be retrieved in both hemipelvis. If no sentinel node is found in one hemipelvis, a side specific lymphadenectomy will be performed.
15936914|NCT03366051|Procedure|Lymphadenectomy|Systematic Pelvic and Para-Aortic Lymphadenectomy
15936958|NCT03365778|Other|Ophthalmologist Educational Intervention|Responses to online survey regarding beliefs and attitudes towards selective laser trabeculoplasty (SLT) before and after educational slide presentation were recorded and compared between physician specialty groups.
15936959|NCT03365765|Drug|Apatinib|Apatinib tablet
15936960|NCT03365765|Drug|Oxaliplatin|Oxaliplatin Intravenous
15936961|NCT03365765|Drug|5-fluorouracil|5-fluorouracil Intravenous
15936962|NCT03365752|Drug|Chloroprocaine|A spinal anesthetic with 2% chloroprocaine (2cc or 40 mg) will be performed
15936915|NCT03366038|Procedure|Shark Mouth Modified Pancreaticojejunostomy|"The remnant of jejunum is closed by continuous suture. The transverse incision is made on the posterior wall of the jejunum (5 centimeters distal to remnant）, which starts at 0.2 centimeter to the mesenteric border and should never exceed the anti-mesenteric border . In case of large pancreas remnant, a longitudinal jejunum incision will be done at anterior part of anastomosis.
~The posterior part of anastomosis is two layers of intermittent suture, including seromuscular suture layer and full thickness suture layer. The anterior part of anastomosis is a single layer full thickness suture. At last, the seromuscular layer of the proximal jejunum is sutured with the anterior pancreatic capsule to cover the anterior part of anastomosis."
15936916|NCT03366025|Diagnostic Test|Serum progesterone measure|Serum Progesterone will be measured in all donors on the day triggering at 8:00 am, 12:00 p, 16:00 pm and 20:00 pm
15936917|NCT03366012|Device|Cytosponge|The Cytosponge consists of a 3cm diameter, polyester, medical grade spherical sponge on a string, compressed within a gelatin capsule. The capsule is swallowed while the patient or the research specialist holds onto the string. After 3-5 minutes the gelatin capsule dissolves allowing the spherical sponge to expand. The sponge is then retrieved by gently pulling on the string, thus collecting cells along the passageway through the entire length of the esophagus. The sample is then put into a preservative to be processed for immunohistochemical testing for trefoil factor 3 (TFF3) to determine diagnosis of Barrett's esophagus.
15936918|NCT03365999|Drug|Oral Tranexamic Acid|Patients undergoing total knee replacement who will receive three doses of tranexamic acid administered orally (1 prior to surgery and 2 subsequent to surgery).
15936919|NCT03365999|Drug|Oral Aminocaproic Acid|Patients undergoing total knee replacement who will receive three doses of aminocaproic acid administered orally (1 prior to surgery and 2 subsequent to surgery).
15936920|NCT03365986|Diagnostic Test|genetic screening|Patients receive genetic test to see whether they have germline cancer susceptibility gene mutations
15936921|NCT03365960|Dietary Supplement|Watermelon Rind|watermelon rind
15936922|NCT03365960|Dietary Supplement|Watermelon Flesh|watermelon flesh
15936923|NCT03365960|Dietary Supplement|Watermelon Seeds|watermelon seeds
15936924|NCT03365960|Dietary Supplement|Placebo|Control Comparator
15936925|NCT03365947|Drug|ARO-HBV Injection|Single or multiple doses of ARO-HBV Injection by subcutaneous (sc) injection
15936926|NCT03365947|Other|Sterile Normal Saline (0.9% NaCl)|Calculated volume to match active comparator
15936927|NCT03365934|Device|ADHESIVE BANDAGE #1|Bandage applied daily to wounded site for 14 days
15936928|NCT03365934|Device|ADHESIVE BANDAGE #2|Bandage applied daily to wounded site for 14 days
15936929|NCT03365934|Device|ADHESIVE BANDAGE #3|Bandage applied daily to wounded site for 14 days
15936930|NCT03365934|Device|Antibacterial Bandage with 0.8% BZK|bandage with 0.8% Benzalkonium Chloride (BZK) applied daily to wounded site for 14 days
15936931|NCT03365934|Other|Intact and No Bandage|This test site will remain intact (not wounded) and not treated with a bandage, serving as a negative control site.
15936932|NCT03365934|Other|Wounded and No Bandage|This test site will be wounded but will not be treated with a bandage, serving as the positive control site.
15936933|NCT03365921|Biological|Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.|Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
15936934|NCT03365908|Procedure|Adductor Canal Nerve Block|An adductor canal nerve block with 15 mL of 0.5% ropivacaine will be performed pre-operatively by Anesthesiology.
15936935|NCT03365908|Drug|Ropivacaine injection|15 mL of 0.5% ropivacaine will be administered for the adductor canal block
15936936|NCT03365895|Procedure|Diffusion Tensor Imaging|Undergo non-enhanced MRI using MRN and DTI
15936937|NCT03365895|Other|Laboratory Biomarker Analysis|Correlative studies
15936938|NCT03365895|Procedure|Magnetic Resonance Imaging|Undergo non-enhanced MRI using MRN and DTI
15936939|NCT03365895|Other|Questionnaire Administration|Ancillary studies
15936940|NCT03365882|Biological|Cetuximab|Given IV
15936941|NCT03365882|Drug|Irinotecan Hydrochloride|Given IV
15936942|NCT03365882|Other|Laboratory Biomarker Analysis|Correlative studies
15936943|NCT03365882|Biological|Pertuzumab|Given IV
15936944|NCT03365882|Biological|Trastuzumab|Given IV
15936945|NCT03365882|Device|HER-2 testing|Central testing of HER-2 for eligibility
15936946|NCT03365869|Drug|Sirolimus|Sirolimus or placebo were added to patients every day
15936947|NCT03365856|Other|observational study|as clinical practice
15936948|NCT03365843|Device|Montage bone putty|Application of bone putty on cut sternal surfaces prior to application of conventional wires for closure of sternum during cardiac surgery.
15936949|NCT03365843|Other|Conventional Sternal Closure|Closure of sternum with standard wire cerclage.
15936950|NCT03365830|Diagnostic Test|FertQol, Beck's Depression Inventory, Beck's Anxiety Inventory|These 3 scale will be given to patients to fill up who takes infertility treatments
15936951|NCT03365817|Drug|Opioids taper off|Decrease of 10% of opioid daily dose every one to two weeks until discontinuation for up to six months.
15936952|NCT03365817|Drug|Opioid stable treatment|No changes on prescribed opioids and adjuvant medication for the next six months
15936953|NCT03365804|Device|3D Printed Brace|All subjects' body shape will be scanned to generate sterolithography (STL) files for 3D printing.
15936954|NCT03365791|Biological|PDR001|PDR001 is a high-affinity, ligand-blocking, humanized anti-programmed death-1 (PD-1) IgG4 antibody that blocks the binding of Programmed death-ligand 1 (PD-L1) and programmed death-ligand 2 (PD-L2) to PD-1.
15936955|NCT03365791|Biological|LAG525|LAG525 is a high-affinity, ligand-blocking, humanized anti-LAG-3 IgG4 antibody which blocks the binding of the known LAG-3 ligand MHC class II to LAG-3.
15936956|NCT03365778|Other|Patient Educational Intervention|Patients will respond to 5 questions regarding selective laser trabeculoplasty (SLT) versus topical medication to lower eye pressure. Then they will receive educational materials including 20 printed slides and view a 3 minute video on safety and efficacy of SLT. If patients agree to SLT, assistance in scheduling will be provided.
15936957|NCT03365778|Other|Usual Care|Patients will respond to 5 questions regarding selective laser trabeculoplasty (SLT) versus topical medication to lower eye pressure. No other guidance will be provided.
15937142|NCT03364335|Drug|Leu Sil 4.0mg|Leu 1100 mg + 4mg Sil BID
15936963|NCT03365752|Drug|Mepivacaine|A spinal anesthetic with 1.5% Mepivacaine (3cc or 45 mg) will be performed
15936964|NCT03365752|Drug|General Anesthetics|General anesthetics will be administered intravenously
15936965|NCT03365739|Dietary Supplement|Active Comparator 1|Mango (pulp/flesh) (500 g)
15936966|NCT03365739|Dietary Supplement|Active Comparator 2|Mango (500 g) + Vitamin C (100 mg)
15936967|NCT03365739|Dietary Supplement|Control Comparator|Vitamin C (100 mg)
15936968|NCT03365726|Diagnostic Test|Dobutamine stress test with trans-esophageal echocardiography|"Dobutamine stress echocardiography will be performed: before skin incision and at the end of surgery.
~After a TEE evaluation at rest to assess myocardial structure, function and potential regional wall motion abnormalities, dobutamine infusion will be started
~If no regional wall motion abnormalities will be detected, a dobutamine stress echocardiography will be started at the range infusion of 50 γ/kg/min (ADST: Accelerated Dobutamine Stress Test). The Test will be continued up to the 85% of maximum heart rate adjusted for the patient age and echo images will be stored.
~If regional wall motion abnormalities are present, a gradual dobutamine stress test will be started at the initial dose of 10 mcg/kg/min (GDST: Gradual Dobutamine Stress Test) and it will be increased every 3 minutes until the 85% of maximum heart rate, adjusted for patient's age (maximal dose: 40 mcg/kg/min) and echo images will be stored."
15936969|NCT03365700|Procedure|Radiofrequency Ablation|Left atrial catheter ablation with pulmonary vein antrum isolation documented by a circular mapping catheter.
15936970|NCT03365700|Procedure|Cryoballoon ablation|Cryoballoon pulmonary vein isolation with the Arctic Front Advance® System or any future development generations of this product line. Additional substrate modification is allowed with the catheter type assigned at the index procedure.
15936971|NCT03365687|Dietary Supplement|Vitamin D|2 mL of 50,000 IU/mL at baseline and at 3.5 months with a daily dose of 1 mL (400 IU/mL) for 7 months
15936972|NCT03365687|Dietary Supplement|Placebo|2 mL of placebo at baseline and at 3.5 months with a daily dose of placebo (1 mL) for 7 months
15936973|NCT03365674|Device|Vibration|Vibration applied with vibrator switch-on state (100Hz)
15936974|NCT03365674|Device|Placebo vibration|Vibrator applied with switch-off state
15936975|NCT03365661|Biological|ALT-803|A reduced intensity conditioning starts on Day -6, (CY/FLU/TBI/TLI) followed by infusion of a TCRα/β-deplete haploidentical graft on Day 0. Two doses of ALT-803 are given initially (early) 1 week apart to facilitate NK cell expansion. ALT-803 maintenance (late) for immune reconstitution begins at Day 42 and consists of 4 weekly doses, followed by 4 weeks off. Up to four 8 week treatment courses are permitted. No post-transplant GVHD prophylaxis is administered unless the final donor cell product contains > 2 x 105 α/β T cells/kg recipient weight.
15936976|NCT03365648|Dietary Supplement|Lertal® + standard therapy|"Lertal® is a novel food supplement. Each tablet contains the following active ingredients:
~Quercetin 150 mg: a natural flavonoid that inhibits the release of histamine, leukotrienes, PGD2, IL (IL-6, IL-8, TNF-alpha).
~Perilla frutescens 80 mg: A dry extract of the seeds containing rosmarinic acid, luteolin, apigenin and crysoeriol that inhibits the release of histamine and expression of interleukins (IL-6, TNF-alpha).
~Vitamin D3 5 mcg (200 IU), which contributes to the normal function of the immune system.
~Standard therapy: antihistamine."
15936977|NCT03365648|Other|Placebo + standard therapy|"Placebo tablet identical in appearance, size and taste to Lertal® tablets. Standard therapy: antihistamine.
~Standard therapy: antihistamine"
15936978|NCT03365635|Drug|Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]|Same as described in arm description
15936979|NCT03365622|Drug|acetaminophen|Active Intravenous doses will consist of a single 1,000mg/100 ml IV dose with contents of commercial vials transferred to an empty sterile IV bag.
15936980|NCT03365622|Drug|Acetaminophen|500mg acetaminophen tablet ,2 capsules oral every six hours for 24 hours
15936981|NCT03365622|Drug|Placebos|Placebo Intravenous doses will consist of 100ml of normal saline transferred to an empty sterile IV bag.
15936982|NCT03365622|Drug|Placebo Oral Tablet|Placebo, opaque capsules that have been filled with inert powder (lactose USP), 2 capsules oral every six hours for 24 hours
15936983|NCT03365609|Drug|triple therapy|Omeprazole+Amoxicillin+Clarithromycin
15936984|NCT03365609|Drug|sequential therapy|the first 7 days : Omeprazole+Amoxicillin, the last 7 days: Omeprazole+Clarithromycin+Metronidazole
15936985|NCT03365609|Drug|bismuth quadruple therapy|Omeprazole+Amoxicillin+Metronidazole+Colloidal Bismuth Subcitrate
15936986|NCT03365609|Drug|concomitant therapy|Omeprazole+Amoxicillin+Clarithromycin+Metronidazole
15936987|NCT03365596|Other|Conventional therapy|According to the status of a patient, optimized therapy will be applied.
15936988|NCT03365557|Procedure|Airway peak pressure|Air was injected into LMA cuff during expiration phase to make intracuff pressure achieve the level of airway peak pressure. If there's any leakage, increase 5 cmH2O every time till there's no air leakage from the mouth.
15936989|NCT03365544|Other|Time-restricted eating|Groups will be required to only ingest calories in their designated 8 hour eating window.
15936990|NCT03365531|Other|Alternate Daily Fasting (ADF)|See ADF arm for details
15936991|NCT03365531|Other|Caloric Restriction (CR)|See CR arm for details
15936992|NCT03365518|Behavioral|Cognitive Behavioural Therapy (CBT)|Sessions consist of CBT tools as well as sex therapy techniques and education. The CBT treatment was adapted from the mindfulness-based treatment, but all mentions of mindfulness have been replaced with CBT principles. The therapeutic content presented in this treatment arm is manualized.
15936993|NCT03365518|Behavioral|Mindfulness-Based Therapy|The mindfulness-based treatment was developed based on pre-existing mindfulness-based cognitive therapy treatment groups for sexual dysfunction developed by Dr. Lori Brotto at the University of British Columbia Sexual Health Laboratory, mindfulness in Sex therapy and Intimate Relationships (MSIR) treatment group developed by Kocsis and Newbury-Helps (2016), and expert input. Sessions consist of mindfulness-based training as well as sex therapy techniques and education. The therapeutic content presented in this treatment arm is manualized.
15936994|NCT03365492|Device|BioFreedom™ BA9™ drug-coated stent|Drug-coated stent for coronary arteries
15936995|NCT03365479|Drug|Iloprost|Single administration of inhaled iloprost 2.5 μg delivered via Breelib nebulizer
15936996|NCT03365466|Drug|Low dose aspirin|LDA 25mg tid
15936997|NCT03365466|Drug|Low molecular weight heparin|LMWH 5000u IH qd
15936998|NCT03365466|Drug|Low dose aspirin plus low molecular weight heparin|LDA 25mg tid + LMWH 5000u IH qd
15936999|NCT03365466|Drug|no treatment|Patients who did not receive any treatment.
15937000|NCT03365453|Other|frailty evaluation|frailty and comorbidity scores
15937001|NCT03365440|Device|esoECG-3D catheter|Recording of esophageal ECGs with the investigational medical device (IMD). Recording of respiration with a commercial breathing sensor.
15937002|NCT03365427|Other|APP|An APP designed for patients experienced TKA, including on-line lessons on the action, frequency, intensity of rehabilitation exercises, and reporting system monitored by stuff from surgery team.
15937003|NCT03365414|Biological|Albumin (Human) 5%, USP|Albumin (Human) 5%, USP. Intravenous Solution. Plasma Substitute/Blood Derivative
15937004|NCT03365414|Drug|Normal Saline 0.9% Infusion Solution Bag|Placebo Normal Saline 0.9% Infusion Solution Bag.
15937005|NCT03365401|Procedure|decompression surgery|undertake decompression surgery
15937006|NCT03365401|Procedure|nonsurgical treatment|complete on bed with prevention of complication
15937007|NCT03365388|Drug|Sodium Hyaluronate|Hyaluronic acid is a component of synovial fluid. N- is glucuronic acid and N-acetylglucosamine repeating disaccharide unit form
15937008|NCT03365388|Drug|Aerzhi|Sodium Hyaluronate Injection can cover and protect joint tissue, improve lubrication function, and penetrate degenerative cartilage
15937009|NCT03365375|Behavioral|MBSR Referral|Referral for mindfulness-based stress reduction (MBSR), a structured meditation training program consisting of 8 weekly group sessions.
15937010|NCT03365375|Other|Usual Care Referral|Referral to PCP or Psychiatry
15937011|NCT03365362|Drug|Long-Term Varenicline|Varenicline tablet x 24 weeks
15937012|NCT03365362|Drug|Short-Term Varenicline|varenicline tablet for 12 weeks, followed by placebo tablet manufactured to mimic varenicline 1 mg tablet
15937013|NCT03365362|Behavioral|Directly Observed Therapy|Varenicline doses are administered by opioid treatment program nurses
15937014|NCT03365362|Behavioral|Self Administered Therapy|Varenicline doses are self-administered
15937015|NCT03365349|Other|"participating in a session of living theatre"|"participating to a session of living theatre which consists in writing a story about life with diabetes, which is then transformed to a script to be played by professional actors co-directed by the patient with the support of the Director to create a short play"
15937016|NCT03365349|Other|writing workshop|"one session consisting for the patient of writing a Letter to his/her own diabetes and then to read it to the group of patients and the healthcare providers."
15937017|NCT03365336|Drug|polyherbal formulation|Each Flu Care consist of 350 mg of polyherbal component
15937018|NCT03365336|Drug|Oseltamivir 75mg|All the participant has to take 75 mg of oseltamivir for five days.
15937019|NCT03365323|Other|Periprosthetic Joint Infection|Periprosthetic Joint Infection is diagnosed according to the diagnosing criteria from the Workgroup of the Musculoskeletal Infection Society.
15937020|NCT03365323|Other|Non-Periprosthetic Joint Infection|PJI can not be diagnosed for the lack of clinical evidence according to the diagnosing criteria from the Workgroup of the Musculoskeletal Infection Society.
15937021|NCT03365310|Drug|C. longa, curcuminoids , Z. officianale, O. sanctum along with 200 ml of Milk|Polyherbal formulation along with standard of care
15937022|NCT03365310|Other|Standard of Care|Usual standard of care for consist of exercise, caloric and protein support, vitamin D, reduction of polypharmacy along with medical management of health condition, assessment of care needs and provision of care. These will be determined on case by case basis by research clinician.
15937023|NCT03365297|Drug|Apalutamide|240mg (4x60mg) oral tablets daily over a max. of 90 days
15937024|NCT03365284|Device|Smart Kneebrace with a smart phone app|Smart Kneebrace will be used during the rehabilitation. Patients wearing the Smart KneeBrace are able to know their daily activity summary and exercise performance during rehabilitation training through a smart phone app.
15937025|NCT03365284|Other|regular rehabilitation procedure|regular rehabilitation procedure, especially muscle strengthening exercises
15937026|NCT03365271|Procedure|drainage|Applying a drain tube during TKA procedure
15937027|NCT03365271|Procedure|non-drainage|No drain tube will be applied during TKA procedure
15937028|NCT03365258|Dietary Supplement|Trophic feeding|Non-blind to randomize to trophic feeding group and volume based feeding group in the first six days (Day 0->Day 6). The definition of trophic feeding is continue feeding with feeding rate: 20 kcal/hr.
15937029|NCT03365258|Dietary Supplement|volume-based feeding|Non-blind to randomize to trophic feeding group and volume based feeding group in the first six days (Day 0->Day 6). The definition Volume-based feeding also use continue feeding by feeding protocol
15937030|NCT03365245|Device|Microperimetry|Microperimetry is performed at three different days
15937031|NCT03365245|Device|automated visual field|Automated visual field ist performed at three different days
15937032|NCT03365232|Device|non custom base attachment|non custom base attachment
15937033|NCT03365232|Device|custom base attachment|custom base attachment
15937034|NCT03365219|Device|Alexis O-Ring Wound Retractor|A flexible self-retaining plastic Alexis retractor was used in place of standard surgical retractors.
15937035|NCT03365219|Other|Standard Surgical Retractors|Routine hand-held metal retractors as needed by the surgical team
15937036|NCT03365206|Other|Questionnaire on practices and knowledge in terms of oral hygiene|Questionnaire on practices and knowledge in terms of oral hygiene during a dental consultation
15937037|NCT03365193|Diagnostic Test|Transesophageal Echocardiography|Standard transesophageal echocardiography will be performed as clinically indicated by treating physicians.
15937038|NCT03365180|Device|Starter Kit Algorithm|Long acting insulin titration to target
15937039|NCT03365167|Radiation|LANAP (Laser Assisted New Attachment Procedure)|radiation of Nd:YAG laser in periodontal pocket
15937040|NCT03365167|Radiation|LANAP off|radiation of Nd:YAG laser in off mode in periodontal pocket
15937041|NCT03365154|Device|Cardio Flow FreedomFlow™ Orbital Atherectomy System treatment|Occlusive lesions will be treated using atherectomy with or without adjunctive low pressure balloon angioplasty.
15937042|NCT03365154|Device|Balloon Angioplasty|Low pressure balloon angioplasty may be used following atherectomy
15937043|NCT03365141|Drug|Triamcinolone acetonide 0.4mg/cc|"Intralesional injection of dilute triamcinolone acetonide with 2% lidocaine (400mg/20 mL) would be performed to reduce pain when injecting the drug.
~Once weekly, for a total of 12 weeks"
15937044|NCT03365141|Device|Phototherapy (NBUVB or excimer laser)|NBUVB or excimer laser treatment weekly
15937045|NCT03365141|Drug|Topical tacrolimus|Application of topical tacrolimus ointment twice a day
15937046|NCT03365115|Drug|Intrathecal morphine|Intrathecal morphine 100 mcg will be injected.
15937047|NCT03365115|Drug|Intrathecal fentanyl|Intrathecal fentanyl 25 mcg will be injected.
15937048|NCT03365102|Device|anodal tDCS over the rIFG,|tDCS at a constant current of 1.5 milliampere (mA) will be applied for one 20-minute session over the right inferior frontal gyrus . Resting-state EEG for 10 minutes will be recorded immediately prior to and after tDCS. After post-tDCS resting state EEG is acquired, EEG is recorded to extract Evoked Response Potentials in a single-blind procedure. The participants and assessors will be blind to experimental condition.
15937049|NCT03365102|Device|anodal tDCS over the lOFC,|tDCS at a constant current of 1.5 mA will be applied for one 20-minute session over the left orbitofrontal cortex . Resting-state EEG for 10 minutes will be recorded immediately prior to and after tDCS. After post-tDCS resting state EEG is acquired, EEG is recorded to extract Evoked Response Potentials in a single-blind procedure. The participants and assessors will be blind to experimental condition.
15937050|NCT03365102|Device|sham tDCS stimulation condition|In the sham condition, the current will be ramped up to 1.5 mA for 30 seconds and then ramped back down to 0. As this commonly used sham procedure produces a brief tingling sensation, participants are kept unaware of their experimental condition. Resting-state EEG for 10 minutes will be recorded immediately prior to and after the sham tDCS. After post-sham stimulation resting state EEG is acquired, EEG is recorded to extract Evoked Response Potentials in a single-blind procedure. The participants and assessors will be blind to experimental condition.
15937051|NCT03365089|Procedure|Collateral vein ligation|Collateral venous flow will be interrupted by ultrasound-guided ligation of venous side branches.
15937052|NCT03365076|Other|Physical activity|Aerobic physiocal activity as stated in Arm A
15937053|NCT03365063|Other|Active Knowledge Translation|"Integration of the KFRE in the CPCSSN DPT - The DPT will report the output from the KFRE for all patients with CKD Stages G3-G5 from the clinic sites. The risk output will include interpretation and automated categorized risk of progression to kidney failure, and will recommend actions based on the KFRE risk based care pathway.
~Audit and Feedback - Providers at CPCSSN clinics receive sentinel feedback reports on a panel of chronic conditions and quality improvement targets. The investigators will add CKD to the feedback report for the intervention sites, and provide detailed feedback on the practices' risk profile.
~Medical Detailing - The intervention CPCSSN clinics will receive a standardized presentation to clinic staff by the principal investigator, who will provide the evidence for the accuracy of the KFRE and guidance on implementation of a risk based treatment pathway, as well as describe the supporting visual aids."
15937054|NCT03365050|Other|No Intervention Given|No Intervention to be given
15937055|NCT03365037|Drug|Electret electrostatic physiotherapyFilm|Patients with acute soft tissue injury treated with electret electrostatic physiotherapyFilm
15937056|NCT03365037|Drug|Fracture healing film|Patients with acute soft tissue injury treated with Fracture healing film
15937057|NCT03365024|Behavioral|Computerized Cognitive Behavioral Therapy for Insomnia|A computerized insomnia intervention that employs the same behavioral, educational, and cognitive treatment components that underlie non-computerized CBT-I.
15937058|NCT03365024|Behavioral|Sleep Education|A web-based program will deliver components of sleep education via an Internet platform
15937059|NCT03365011|Drug|Nitrous oxide gas for inhalation|Nitrous oxide gaseous mixture (50% nitrous oxide and 50% oxygen) for 40 minutes duration under anesthesia supervision with monitoring according to standards set by the American Society of Anesthesiologists.
15937060|NCT03365011|Drug|Placebo gas for inhalation|Placebo gaseous mixture (50% nitrogen and 50% oxygen) for 40 minutes duration under anesthesia supervision with monitoring according to standards set by the American Society of Anesthesiologists.
15937061|NCT03364998|Drug|Damoctocog (Jivi, BAY94-9027)|60 international units (IU)/kg, given as a 10 minute injection, 1 dose
15937062|NCT03364998|Drug|Elocta|60 IU/kg, given as a 10 minute injection, 1 dose
15937063|NCT03364985|Drug|DWP16001|DWP16001 tablets
15937064|NCT03364985|Drug|Placebo|DWP16001 placebo-matching tablets, Active control placebo-matching tablets
15937065|NCT03364985|Drug|Dapagliflozin|Forxiga®
15937066|NCT03364972|Device|Cataract surgery|Conventional small-incision phacoemulsification cataract surgery with insertion of intraocular lens implant
15937067|NCT03364959|Other|Corticosteroids inhalation|Flixotide inhalation followed by Qvar inhalation through a nasal filter and a mouth filter located in a partitioned face mask and delivered to an infant with asthma via a Tipshaler® holding chamber
15937068|NCT03364959|Other|Corticosteroids inhalation|Qvar inhalation followed by Flixotide inhalation through a nasal filter and a mouth filter located in a partitioned face mask and delivered to an infant with asthma via a Tipshaler® holding chamber
15937069|NCT03364946|Other|No intervention|No intervention, observational study
15937070|NCT03364933|Behavioral|Primary intensivist and nurses|"Primary intensivist will have no active role in the daily management of patients. The primary intensivist should facilitate decision-making, be a liaison between the patient/family and PICU team, and be a resource of information for all. Responsibilities of primary intensivist:
~Weekly check-in with and availability to patient/family
~Attendance at family meetings
~Availability to PICU team
~Primary nurses will be a team of up to 7 ICU nurses who will provide as much of the bedside care as possible. Responsibilities of primary nurses:
~Maintain a primary nurse binder (paper format) for on-going communication about the patient among the team members; it will be their discretion what is information is communicated.
~The Primary Nurse or delegate will be involved in all team/family meetings and will be expected/given an opportunity to speak during these meetings."
15937071|NCT03364907|Other|HIPEC with flushing afterwards|flushing with saline fluid after HIPEC
15937072|NCT03364907|Other|HIPEC without flushing afterwards|NO flushing with saline fluid after HIPEC
15937073|NCT03364868|Drug|Oral Insulin|treatment starting at 4 months - 7 months until age 3.0 years; dose escalation scheme: daily treatment with 7.5 mg or placebo for 2 months; increasing to daily treatment with 22.5 mg or placebo for the following 2 months; increasing to daily treatment with 67.5 mg or placebo until the end of the treatment period.
15937143|NCT03364335|Drug|Leu Met Sil 1.0mg|Leu 1100 mg + Met 500mg + 1mg Sil BID
15937144|NCT03364335|Drug|Leu Met Sil 4.0mg|Leu 1100 mg + Met 500mg + 4mg Sil BID
15937074|NCT03364868|Other|Placebo|treatment starting at age 4 months - 7 months until age 3.0 years; daily treatment with insulin or placebo capsules containing filling substance (microcrystalline cellulose).
15937075|NCT03364855|Other|Star excursion balance test|Star excursion balance test,
15937076|NCT03364855|Other|Kinesthetic Ability Trainer 2000|Kinesthetic Ability Trainer 2000
15937077|NCT03364855|Other|SEBT and KAT 2000|Star excursion balance test and Kinesthetic Ability Trainer 2000
15937078|NCT03364842|Drug|Furosemide|Administering furosemide
15937079|NCT03364829|Drug|Indacaterol/Glycopyrronium|
15937080|NCT03364816|Procedure|TDR|total artificial disc replacement
15937081|NCT03364803|Other|Cushing's QoL (Quality of Life Questionnaire)|Cushing's QoL is a validated disease specific questionnaire consisting of 12 questions on a five-point Likert scale ranging from always to never. The total score ranges from 12 to 60, with a lower score indicating a greater negative impact on health related QoL. This is converted to a 0-100 scale, 0 indicating the worst and 100 indicating the best QoL
15937082|NCT03364803|Other|Nottingham Health Profile (NHP)|NHP is used in patients to assess general health and quality of life. This assessment consists of 38 yes/no questions that are subdivided into six scales assessing impairments: pain (eight items), energy level (three items), sleep (five items), emotional reactions (nine items), social isolation (five items) and physical mobility (eight items). A higher score indicates more impairment
15937083|NCT03364803|Other|Hospital Anxiety and Depression Scale (HADS)|HADS consists of 14 items pertaining to anxiety and depression, with each item measured on a four-point scale. Total scores for the anxiety and depression subscales range from 0 to 21. A higher score indicates greater symptomatology
15937084|NCT03364803|Other|Perceived Stress Scale (PSS)|The PSS predicts both objective biological markers of stress and increased risk of disease in patients with higher stress levels.
15937085|NCT03364803|Other|Barratt's Impulsivity Scale (BIS)|BDI and BIS in combination have demonstrated that depression and/or binge eating may be mediating factors for the outcome of obesity
15937086|NCT03364803|Other|Beck Depression Inventory (BDI)|BDI and BIS in combination have demonstrated that depression and/or binge eating may be mediating factors for the outcome of obesity
15937087|NCT03364803|Other|State-Trait Anxiety Inventory (STAI)|The STAI provides data to help distinguish between anxiety and depression.
15937088|NCT03364803|Other|State Food Craving Questionnaire-State (FCQ-S)|The FCQ-S consists of 15 items assessing: desire to eat, anticipation of positive reinforcement from eating, anticipation of negative reinforcement (reduction of negative affect) from eating, lack of control over eating, and (physiological) hunger; higher scores reflect stronger food craving. Participants respond, using a Likert-type scale, how much each item is true of them right now.
15937089|NCT03364803|Other|Trait Food Craving Questionnaire-Trait (FCQ-T)|Trait food craving will be assessed with the Food Craving Questionnaire-Trait (FCQ-T). The FCQ-T consists of 39 items assessing: intentions/plans to eat, anticipation of positive reinforcement from eating, anticipation of negative reinforcement from eating, lack of control over eating, preoccupation with food, (physiological) hunger, emotions preceding or following food cravings or eating, environmental cues that may elicit food cravings, negative emotions including guilt experienced as a consequence of food cravings, and/or indulging such cravings; higher scores again indicate higher trait craving. Individuals are asked to respond, using a Likert-type scale, how much each item is true of them in general.
15937090|NCT03364803|Other|Visual Analogue Scale (VAS)|"A validated visual analogue scale (VAS) questionnaire will be completed in the fasting state. The VAS consists of 100-mm lines with words anchored at each end describing extreme sensations of hunger, prospective consumption (How much do you think you can eat?), fullness, and satisfaction, as well as craving (sweet, salty, fatty or savory). Patients will be asked to make a vertical mark across the line corresponding to their feelings. Quantification will performed by measuring the distance from the left end of the line to the mark."
15937091|NCT03364803|Other|Sensitivity to Reinforcement of Addictive and other Primary Rewards (STRAP-R) food variant|A validated questionnaire that assesses perceived subjective value attributed to expected/hypothetical foods and other primary reinforcers will be administered. This variant of this questionnaire was initially developed by Dr. Goldstein to assess 'liking' and 'wanting' of expected drug rewards for patients with cocaine addiction. The current assessment uses a modified version to assess 'liking' and 'wanting' for food.
15937092|NCT03364790|Procedure|PLIF|Randomly include the 30 participants diagnosed LSS and knee arthritis or limited by knee extension greater than 10 °who need to be operated and then performed PLIF or PLF; include anothr ones of 30 need to be with the implementation of TKA;and another group with the same diagnosis will be underwent both of surgeries in one stage.
15937093|NCT03364790|Procedure|TKA|Randomly include the 30 participants diagnosed LSS and knee arthritis or limited by knee extension greater than 10 °who need to be operated and then performed PLIF or PLF; include anothr ones of 30 need to be with the implementation of TKA;and another group with the same diagnosis will be underwent both of surgeries in one stage.
15937094|NCT03364777|Other|emotional state|anxiety or depression state evaluated by emotional scale
15937095|NCT03364764|Drug|Sirolimus|On refractory PRCA patients, sirolimus was tried. Dosage: 2mg QD for the first day, then 1 mg QD. Medication time should last at least 6 months.
15937096|NCT03364751|Other|IQOS|Patients will switch from cigarette smoking to ad libitum IQOS use.
15937097|NCT03364751|Other|Cigarette|Patients will continue to smoke cigarettes ad libitum.
15937098|NCT03364738|Biological|rhPTH(1-84)|Participants will receive rhPTH(1-84) SC injection in the thigh (alternate thigh every day) QD.
15937099|NCT03364725|Drug|Glecaprevir-pibrentasvir|Glecaprevir-pibrentasvir will be dispensed to 30 patients recently detoxed off heroin in an acute detox center.
15937100|NCT03364712|Other|routine medical care, venipuncture|
15937101|NCT03364699|Dietary Supplement|dietary supplementation|The volunteers ingested 3 g daily of Soybean lecithin or fish oil rich in docosa-hexanoic acid (DHA) containing 1.5 g DHA and 0.3 g EPA (DHA:EPA = 5:1) or fish oil rich in eicosapentaenoic acid (EPA) containing 1.6 g EPA and 0.3 g DHA (EPA:DHA = 5.4:1) during 60 days.
15937102|NCT03364699|Other|Exercise|All volunteers performed two half-marathons. In the first half-marathon, all participants were not supplemented. In the second half-marathon, all participants were supplemented. Blood samples were collected before and after both half-marathon race.
15937145|NCT03364335|Drug|Placebo|Placebo
15937146|NCT03364322|Other|Observation|Observation
15937103|NCT03364686|Biological|Biotin-Labeled Red Blood Cells|We will collect 500 mL of blood. The blood will be processed and split into two bags and labeled with a naturally occurring vitamin, biotin. The blood will then be re-infused back into the same participant at 2 time points (5-7 days and 35-42 days after storage).
15937104|NCT03364673|Other|Fitness Tracker|Fitness trackers (e.g. Fitbit) are accelerometers that are worn on the wrist and tracks users' heart rate continuously in addition to steps, distance, calories, and active minutes
15937105|NCT03364673|Other|Social Incentive (Way to Health)|The Way to Health platform is an automated information technology platform that integrates wireless devices, clinical trial randomization and enrollment processes, messaging (text, e-mail or voice), self-administered surveys, automatic transfers of financial incentives, and secure data capture for research purposes.
15937106|NCT03364660|Device|Epidural Stimulation|Eligible participants will be implanted with 16-electrode epidural array and epidural stimulator in the spinal cord.
15937107|NCT03364660|Biological|Stand Training|Standing in a body weight support (BWS) harness on a treadmill or standing in a standing frame.
15937108|NCT03364647|Other|Arm A - blood flow restriction training|Group receive standard of care plus blood flow restriction training
15937109|NCT03364647|Other|Arm B - standard of care|Group will receive standard of care plus a sham version of blood flow restriction training
15937110|NCT03364634|Diagnostic Test|Intracranial pressure monitoring|Weekly ICP monitoring sessions beginning at discharge from the neuro-intensive care unit and carried out until 1 month after cranioplasty.
15937111|NCT03364608|Drug|AS MDI 90 μg|AS MDI 90 μg (2 actuations of 45 μg/actuation)
15937112|NCT03364608|Drug|AS MDI 180 µg|AS MDI 180 μg (2 actuations of 90 μg/actuation)
15937113|NCT03364608|Other|Placebo MDI|Placebo MDI (2 actuations)
15937114|NCT03364608|Drug|Proventil 90 μg|Proventil 90 μg (1 actuation of 90 μg/actuation)
15937115|NCT03364608|Drug|Proventil 180 μg|Proventil 180 μg (2 actuations of 90 μg/actuation)
15937116|NCT03364595|Procedure|plate fixation|ORIF of the radial head fracture
15937117|NCT03364595|Procedure|replacement|replacement of the radial head fracture
15937118|NCT03364582|Other|Observed dietary pattern|No intervention will be used. This is an observational study with dietary patterns as main exposure
15937119|NCT03364569|Procedure|Tranexamic acid|Participants with taking tranexamic acid (2 x 1g per day) as a preventive and without adjuvant treatment.
15937120|NCT03364556|Other|No intervention|
15937121|NCT03364543|Other|Access to the Medical-Legal Partnership Group|The Medical-Legal Partnership Group are lawyers in clinics who address health-harming legal needs.
15937122|NCT03364543|Other|Access to social worker and a community worker|Access to social worker and a community worker, but no systematic process for addressing health-harming legal needs.
15937123|NCT03364530|Drug|Gemcitabine-Oxaliplatin Regimen|"Vascularisation of hepatic tumors is almost exclusively provided by the hepatic artery.
~Gemcitabine and oxaliplatin have a high rate of hepatic extraction during the first passage, thus allowing the drugs to reach high intra-tumoral concentrations with low systemic toxicity."
15937124|NCT03364530|Procedure|Hepatic intra arterial chemotherapy|"The implantation of a hepatic arterial catheter has now been mastered by interventional radiologists and makes it possible to increase the intra-tumoral concentration of the drugs and probably to limit their systemic toxicity.
~Very recently, we have reported that this combination in progressive IHC following systemic gemcitabine/oxaliplatin has led to partial responses and allowed certain patients to benefit from curative treatment.
~This suggests that the intra-arterial approach increases the efficacy of these 2 drugs. For locally-advanced IHC, such a loco-regional approach is worth exploring in this poor-prognosis tumor."
15937125|NCT03364517|Other|Predictor score of the imminence of a childbirth (SPIA)|The SPIA score is based on the analysis of 6 types of criteria: panic during the call, the possibility of having a telephone contact with the parturient, the urge to push and if so for how long, the rhythm of the CU, some aggravating factors (history of fast delivery or at home, maternal age between 26 and 35 years, lack of follow-up of pregnancy) and 2 minor factors (nulliparity and the taking of a tocolytic treatment). Each criteria is between 0 to 8, except for the 2 minor criteria for which 7 and 3 points are removed if they are present. This gives a score between -10 and +33, which is weighted according to the admission time estimated at the hospital (30 minutes, 1h and 2h).
15937126|NCT03364504|Other|urine collection|3 urine collections during 24 hours
15937127|NCT03364491|Drug|Tranexamic Acid|A single dose of Tranexamic Acid (1 gram) in normal saline for a total of 50cc, administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
15937128|NCT03364491|Drug|Placebo|50 cc normal saline administered intravenously immediately following umbilical cord clamping (or as soon as possible afterward)
15937129|NCT03364478|Procedure|DML group|The group underwent laparoscopic right hemicolectomy with dorsal and medial hybrid approach.
15937130|NCT03364478|Procedure|MLA group|The group underwent laparoscopic right hemicolectomy with traditional medial-to-lateral approach.
15937131|NCT03364465|Other|change of ventilatory settings|change of tidal volume during one-lung ventilation
15937132|NCT03364439|Drug|Treatment plan|R-CHOP14 or R-CHOP21 for 6 cycles Restaging after 2, 4, 6 cycles Consolidation therapy with RT (36 Gy) if PET positive (PET after 6 R-CHOP cycles)
15937133|NCT03364426|Other|No intervention|No intervention - this is was an observational, cross-sectional study to identify potential risk factors associated with stunting
15937134|NCT03364413|Other|Chocolate|Participants will be asked to taste commercially available chocolate varying in sugar, fat and percent cocoa (milk, 70%, 85% and 90% cocoa).
15937135|NCT03364400|Drug|VT1021|Peptide
15937136|NCT03364374|Behavioral|Postural counseling|A therapist will provide verbal/physical cues to improve the participants posture
15937137|NCT03364361|Procedure|Acupuncture|Participants will receive a six-point standardized stress acupuncture (SSA) treatment once a week for 4 weeks. The SSA consists of GV- 20, GV-24.5 (Yin Tang), bilateral LI-4, and bilateral LR-3. This acupuncture protocol has been used as an effective treatment for stress-related symptoms in the operational theater.
15937138|NCT03364348|Drug|Utomilumab|Given IV
15937139|NCT03364348|Drug|Trastuzumab|Given IV
15937140|NCT03364348|Drug|Trastuzumab Emtansine|Given IV
15937141|NCT03364335|Drug|Leu Sil 1.0mg|Leu 1100 mg + 1mg Sil BID
15937149|NCT03364296|Other|Blood Samples|Blood sample retrieved for biological assessment and biobanking
15937151|NCT03364270|Drug|PET/CT Imaging with [F-18] RGD-K5|PET Imaging/scan with [F-18] RGD-K5, PET Imaging/scan with RGD-K5, PET Imaging/scan with K5
15937152|NCT03364257|Diagnostic Test|iDTECT Blood|Next generation sequencing-based shot-gun metagenomic test for the diagnosis of viral or bacterial infections using blood samples
15937153|NCT03364244|Drug|Sildenafil|"[REVATIO® Tablets / REVATIO® OD Film] Adults Usually, sildenafil 20 mg is orally given three times daily. Children aged 1 year or older In children weighing 20 kg or more: Usually, sildenafil 20 mg is orally given three times daily.
~[REVATIO® Dry Syrup for Suspension] Adults Usually, sildenafil 20 mg is orally given three times daily. Children aged 1 year or older In children weighing 8 kg or more but less than 20 kg: Usually, sildenafil 10 mg is orally given three times daily.
~In children weighing 20 kg or more: Usually, sildenafil 20 mg is orally given three times daily."
15937154|NCT03364231|Drug|Umbralisib|Oral Daily Dose
15937155|NCT03364218|Drug|N-Acetyl Cysteine|Nebulized N-Acetyl Cysteine administered every 12 hours
15937156|NCT03364205|Behavioral|solution-focused interview technique|This approach helps an individual make decisions about behavioral change, focusing particularly on his or her past achievements and looking forward to a time when the problems cease to exist.
15937157|NCT03364192|Behavioral|Whole Health Coaching|Veterans Health Administration variation of integrative health coaching.
15937158|NCT03364166|Procedure|surgical excision|"Under general anaesthesia, the buccal squamous cell carcinoma which invaded the buccinator muscle will be excised with the skin of the cheek. This will be done by a safety margins in the soft tissue and the mandible may be resected according to the plan and the invasion of the tumour.
~A neck dissection will be done in all cases of negative or positive neck lymph node.
~Reconstruction of the soft tissue will be done immediately by a major pectorals flap with the skin, also bony reconstruction may be done by a reconstructed plate at the time of surgery then the patients will be prepared for bone graft in another surgery."
15937159|NCT03364153|Drug|Zimura|Zimura Intravitreal Injection
15937160|NCT03364153|Other|Sham|Sham Intravitreal Injection
15937161|NCT03364127|Other|Active Acupuncture|Active Acupuncture two times per week for 5 weeks
15937162|NCT03364127|Other|Placebo Acupuncture|Placebo Acupuncture two times per week for 5 weeks
15937163|NCT03364114|Device|EndoRotor Mucosal Resection System|The EndoRotor® Endoscopic Mucosal Resection System is an automated mechanical endoscopic mucosal resection system for use in the gastrointestinal tract for benign neoplastic or pre-malignant tissue removal by interventional gastroenterologists and GI surgeons. The EndoRotor® System performs both tissue dissection and resection with a single device through an endoscope's instrument biopsy channel.
15937164|NCT03364114|Device|Continued Ablation|Continued ablation control shall include either cryotherapy or continued radial frequency ablation.
15937165|NCT03364101|Dietary Supplement|Placebo Capsule|Composition of the placebo is 100% organic rice flour, manufactured at a facility New York State licensed to produce pharmaceuticals. Capsules will be instructed to commence on day 7 of the study after baseline appointment.
15937166|NCT03364101|Dietary Supplement|POWEROFF Capsule|blend of California Poppy Aerial Part Extract, L-Cystine, L-Theanine,GABA (proprietary Phosphatidylcholine-Palmitic Acid-Oleic Acid Complex), 5-HTP, Magnolia Officinalis Bark Extract, Glycine, Melatonin with 0.5mg of Vitamin B6 (as pyridoxal-5-phosphate).
15937167|NCT03364088|Procedure|Spinal anesthesia with tourniquet|Operation is done under spinal anesthesia and surgical tourniquet is used.
15937168|NCT03364088|Procedure|Spinal anesthesia without tourniquet|Operation is done under spinal anesthesia and without the use of surgical tourniquet.
15937169|NCT03364088|Procedure|General anesthesia with tourniquet|Operation is done under general anesthesia and surgical tourniquet is used.
15937170|NCT03364088|Procedure|General anesthesia without tourniquet|Operation is done under general anesthesia and without the use of surgical tourniquet.
15937171|NCT03364088|Drug|Oxycodone by patient-controlled analgesia (PCA)|PCA device (CADD Legacy PCA Pump, Smiths Medical, Kent, UK) is programmed to give intravenous oxycodone in doses of 0.04 mg/kg (ideal body weight). The minimum time between doses is set to 10 minutes and no more than 4 doses per hour are allowed.
15937172|NCT03364075|Drug|Duloxetine|30 mg for seven days, then increased to 60 mg for seven days
15937173|NCT03364075|Drug|Propranolol|40 mg for seven days, then increase to 60 mg for seven days
15937174|NCT03364075|Genetic|Genotype for SNPs associated to Serotonin and COMT|DNA and RNA extraction from blood samples to identify genetic variants associated to pain pathways
15937175|NCT03364075|Drug|Placebo Treatment|1 capsule BID for two weeks
15937176|NCT03364062|Procedure|cemented shoulder replacement|proximal humeral fracture receiving hemi-shoulder replacement with cement when inserting the stem
15937177|NCT03364049|Drug|MK-7162|oral tablets
15937178|NCT03364049|Biological|Pembrolizumab|IV infusion
15937179|NCT03364036|Drug|Mavenclad®|Participants received Mavenclad® 3.5 milligram per kilogram (mg/kg) of body weight over 2 years, administered as 1 treatment course of 1.75 mg/kg per year.
15937180|NCT03364023|Device|Neurothrombectomy|Medtronic Market-Released Neurothrombectomy Device
15937181|NCT03364010|Behavioral|Evaluation of proprioception|Velocity perception and Position perception
15937182|NCT03364010|Behavioral|Evaluation of motor learning|Motor accurancy and State Estimation with visual perturbations
15937183|NCT03364010|Behavioral|Evaluation of written language|Text reading, Identifying words and Phonological awareness: phonemic blending and phonemic elision
15937184|NCT03363997|Drug|Estriol 0.125 mg/day|Application of one vaginal ring
15937185|NCT03363997|Drug|Estriol 0.250 mg/day|Application of one vaginal ring
15937186|NCT03363997|Drug|Estriol 0.500 mg/day|Application of one vaginal ring
15937187|NCT03363984|Drug|Midazolam|Single oral administration of 2 mg midazolam under fasted conditions/outside of meal times
15937188|NCT03363984|Drug|ID-082|Administration of ID-082 under fasted conditions/outside of meal times
15937189|NCT03363971|Drug|Zhi Kang Capsule|0.3g/capsule, oral, 4 capsules at a time, 3 times a day, half an hour after dinner, warm water delivery; treatment for 6 weeks.
15937190|NCT03363971|Drug|Simulant agent for Zhi Kang Capsule|0.3g/capsule,oral, 4 capsules at a time, 3 times a day, half an hour after dinner, warm water delivery; treatment for 6 weeks.
15937191|NCT03363958|Procedure|Remote Ischemic Preconditioning with Postconditioning|Three cycles of 5 minutes of ischemia and 5 minutes of reperfusion of lower leg 24 hours, immediately before surgery and within 60 minutes after the restoration of coronary blood flow postoperatively.
15937192|NCT03363958|Procedure|Sham RIPC procedure|Three cycles of 5 minutes of inflation and 5 minutes of deflation of artificial lower leg immediately before surgery and within 60 minutes after the restoration of coronary blood flow postoperatively.
15937193|NCT03363945|Biological|MDR-101|Enriched CD34+ hematopoietic stem cells and defined dose of CD3+ T-cells
15937196|NCT03363906|Drug|Dulaglutide (Reference)|Administered SC
15937197|NCT03363906|Drug|Dulaglutide (Test)|Administered SC
15937198|NCT03363893|Drug|CT7001|Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
15937199|NCT03363893|Drug|CT7001 in combination with fulvestrant|Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression in combination with fulvestrant given as 2 x 250mg intramuscular (IM) gluteal injections on Day 1, Day 15, Day 28 and every 28 days thereafter
15937200|NCT03363893|Drug|CT7001 (in original vs enteric capsule)|Cyclin-dependent kinase 7 (CDK7) inhibitor given orally once daily until disease progression
15937201|NCT03363880|Other|trauma treatment team|Establishing the trauma management system included a trauma treatment team. The severe trauma treatment team will be composed by the physicians from departments of emergency, orthopedic trauma, urology, cardiothoracic surgery, neurosurgery, general surgery, anesthesiology, and ICU.
15937202|NCT03363880|Other|Basic experimental settings|Establishing the trauma management system without a trauma treatment team.
15937203|NCT03363867|Drug|Atezolizumab|840mg every 2 weeks (i.e. Day 1 and Day 15 of each 28 day cycle) via intravenous infusion from Cycle 2 onwards.
15937204|NCT03363867|Drug|Bevacizumab|5mg/kg every 2 weeks (i.e. Day 1 and Day 15 of each 28 day cycle) via intravenous infusion.
15937205|NCT03363867|Drug|Cobimetinib|60mg per day, every day for 21 days (i.e. Day 1 to Day 21 of each 28 day cycle)
15937206|NCT03363854|Drug|Tralokinumab|Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous (SC) administration.
15937207|NCT03363854|Drug|Placebo|Placebo contains the same excipients in the same concentration only lacking tralokinumab.
15937208|NCT03363841|Drug|SCY-078|Oral SCY-078
15937209|NCT03363828|Drug|Estrofem|Patients will be asked to obtain self-collected vaginal swabs from the mid-vagina from the beginning of their Estrofem® treatment
15937210|NCT03363815|Drug|CC-90001|CC-90001
15937211|NCT03363815|Drug|Omeprazole|Omeprazole
15937212|NCT03363815|Drug|Midazolam|Midazolam
15937213|NCT03363815|Drug|Warfarin|Warfarin
15937214|NCT03363815|Dietary Supplement|Vitamin K|Vitamin K
15937215|NCT03363815|Drug|Rosuvastatin|Rosuvastatin
15937216|NCT03363815|Drug|Metformin|Metformin
15937217|NCT03363815|Drug|Digoxin|Digoxin
15937218|NCT03363815|Drug|Nintedanib|Nintedanib
15937219|NCT03363789|Biological|Brisement injection|An injection of Lidocaine into the tendon sheath to break up adhesions that could be causing the condition.
15937220|NCT03363789|Procedure|Physical Therapy|Patients will receive a prescription for physical therapy.
15937221|NCT03363776|Biological|BMS-986277|Specified dose on specified days
15937222|NCT03363776|Biological|Nivolumab|Specified dose on specified days
15937223|NCT03363763|Drug|Sirolimus 0.2%|Ointment for topical administration hs x 12 weeks
15937224|NCT03363763|Drug|Sirolimus 0.4%|Ointment for topical administration hs x 12 weeks
15937225|NCT03363763|Drug|Placebo ointment|Placebo ointment comparator for topical administration hs x 12 weeks
15937226|NCT03363750|Behavioral|mind-body-skills group|mind-body skills group program incorporates meditation, guided imagery, breathing techniques, autogenic training, biofeedback, genograms, and self-expression through words, drawings, and movement
15937227|NCT03363737|Behavioral|Transtheoretical Model|Exposure to content on Facebook, either daily (dynamic) or just at one time period (static).
15937228|NCT03363724|Other|HaGuide version 1.0 software module|
15937229|NCT03363711|Other|AYA STEPS|a mobile health application
15937230|NCT03363698|Other|Cough variant asthma treatment|Evaluation of the treatment response to inhaled corticosteroids, long-acting beta-agonists, montelukast, prednisone.
15937231|NCT03363659|Drug|Disulfiram|Disulfiram is taken orally, twice daily.
15937232|NCT03363659|Dietary Supplement|Copper gluconate|Copper gluconate is taken orally, twice daily
15937233|NCT03363659|Drug|Temozolomide|Temozolomide is taken once daily
15937234|NCT03363633|Drug|sodium tetradecyl sulfate|Ultrasound-guided injection with sodium tetradecyl sulfate foam of refluxing perforating veins
15937235|NCT03363633|Device|Compression|20-30 mmHg compression stockings
15937236|NCT03363620|Device|Orthodontic Brackets|arch form development in the orthodontic treatment with 2 different kind of ligation brackets with the same arches protocol in the leveling and alignment phase
15937237|NCT03363620|Device|Orthodontic Brackets|arch form development in the orthodontic treatment with 2 different kind of ligation brackets with the same arches protocol in the leveling and alignment phase
15937238|NCT03363607|Procedure|Digital indirect bonding|Indirect bonding of orthodontic attachments using digital 3D printed transfer tray
15937239|NCT03363607|Procedure|Conventional indirect bonding|Indirect bonding of orthodontic attachments using thermoformed transfer tray
15937240|NCT03363607|Procedure|Intraoral scanning|Intraoral Scanning of the bonded brackets
15937597|NCT03360682|Drug|Tenofovir Disoproxil 245Mg Tablet|Tenofovir 245 MG/day (48 weeks)
15937241|NCT03363607|Procedure|Superimposition and evaluation|superimposition of the brackets' positions before and after bonding and evaluation of the transfer accuracy
15937242|NCT03363581|Behavioral|Food Preference|Buffet meal to assess food preference
15937243|NCT03363568|Behavioral|Adaptive Inhibitory Control Training|Playing computerized stop-signal reaction time tasks that had been modified to increase in difficulty as performance increased.
15937244|NCT03363568|Behavioral|Non-adaptive Inhibitory Control Training|Playing computerized stop-signal reactions time tasks that do not change in difficulty level (non-adaptive).
15937245|NCT03363555|Drug|SHR-1210|A humanized monoclonal immunoglobulin.
15937246|NCT03363542|Dietary Supplement|fruits, vegetables and/or whole grain high fiber rich diet|Dietary education to Increase fruits, vegetables and/or high fiber intake
15937247|NCT03363529|Device|Dynamic light|Dynamic lighting is light that changes in intensity and spectral distribution during the day
15937248|NCT03363529|Device|Standard|Standard lighting is non-dynamical light corresponding to standard hospital lighting.
15937249|NCT03363516|Diagnostic Test|Cerebral 3 Tesla MRI|Subjects will be examined using a 3 Tesla MR750 GE MRI scanner with an eight-channel head coil. All participants will undergo the same MRI protocol, including: whole-brain 3D T1-weighted spoiled gradient recalled (SPGR) (BRAVO, voxel size of 1 × 1 × 1 mm3), DTI (voxel size 2 × 2 × 2 mm3, 27 directions with gradients at a b-value of 1,000 s/mm2 and 4 b = 0 images) and conventional 2D T2-weighted,T2 (FLAIR) and T2 gradient echo.
15937250|NCT03363503|Drug|Salmeterol/Fluticasone Capsair®|Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Capsair® for 8 weeks
15937251|NCT03363503|Drug|Salmeterol/Fluticasone Diskus®|Salmeterol/Fluticasone 50/500 mcg Inhalation Powder (1 puff) twice daily (approximately every 12 hr) via Diskus® for 8 weeks
15937252|NCT03363490|Behavioral|Self-management program|Self-management diary will record the frequency of pain, fatigue and injury of knee joint due to knee OA, if patients maintain proper activities, it will be also recorded by an smart phone APP. Patients diet and intake calorie will also be recorded in the diary，which help clinicians to adjust their diet, control their body weight.
15937253|NCT03363490|Behavioral|Neuromuscular exercise therapy|The exercise therapy is basically combined with neuromuscular training and anti resistance training. The aim is to improve the stability of the joints, enhance sensory motor control of lower extremities, reconstruct neutral position line. The exercise mode, frequency, intensity and duration will be adjusted individually through monitoring patient's pain.
15937254|NCT03363490|Behavioral|Health education|All four groups of patient will receive two times of health education in the first week.
15937255|NCT03363477|Drug|Enoxaparin|
15937256|NCT03363477|Drug|Clexane|
15937257|NCT03363464|Drug|Empagliflozin|Empagliflozin
15937258|NCT03363464|Drug|DPP-4 inhibitor|dipeptidyl peptidase-4 inhibitor
15937259|NCT03363464|Drug|GLP-1 receptor agonist|Glucagon-like peptide-1 receptor agonist
15937260|NCT03363451|Drug|Antibiotics|This is an observation study, no specific antibiotics will be indicated during treatment
15937261|NCT03363438|Other|no intervention survey|there was no intervention this was a survey
15937262|NCT03363425|Drug|Lidocaine Iv|Lidocaine Iv
15937263|NCT03363425|Drug|Dexmedetomidine|dexmedetomidine iv
15937264|NCT03363425|Drug|Normal saline|placebo
15937265|NCT03363412|Device|PTFE-covered stent grafts|Creation of a small diameter intrahepatic shunt between portal and hepatic veins.
15937266|NCT03363399|Diagnostic Test|Flow cytometry analysis of neutrophil myeloperoxidase expression|"Flow cytometry analysis of neutrophil myeloperoxidase expression in peripheral blood samples will be performed within 24 h of MDS diagnostic evaluation and blinded to the reference standard. Peripheral blood samples will be collected in 5 ml (EDTA) anticoagulant plastic tubes and processed within 24 h maximum of collection. The samples will be stored at 4°C overnight.
~Blood samples containing at least 105 neutrophils will be incubated with a panel of antibodies conjugated to fluorochromes, according to the manufacturers' recommendations.
~At least 10,000 cell events will be acquired on a 3-laser, 8-color flow cytometer and analyzed using Becton Dickinson (BD) Fluorescence-activated cell sorting (FACS) Diva Software version 6. Each marker will be expressed as median, geometric and arithmetic mean, regular and robust coefficient of variation."
15937267|NCT03363386|Procedure|Proprioceptive Exercises|Patients trained for proprioceptive exercises
15937268|NCT03363386|Procedure|Resistive Exercises|Patients trained for resistive exercises
15937269|NCT03363386|Procedure|Aerobic Exercise|Patients were educated with treadmill walking for 30 minutes of each exercise session
15937271|NCT03363347|Drug|Redifferentiation with retinoid acid|In this retrospective study, patients with radioiodine refractory papillary thyroid cancer routinely received (clinical indication, no study medication was given) retinoid acid for redifferentiation prior to further course of radioiodine therapy.
15937272|NCT03363334|Drug|Fostamatinib disodium 100 mg|Fostamatinib Disodium tablet 100 mg PO bid (morning and evening)
15937273|NCT03363334|Drug|Fostamatinib disodium 150 mg|Fostamatinib Disodium tablet 150 mg PO bid (morning and evening)
15937274|NCT03363321|Biological|PF-06741086|PF-06741086 subcutaneous injection
15937275|NCT03363308|Behavioral|training for health care workers supplmented by QI teams|Jhpiego will deliver maternal and newborn health and family planning (MNH+FP) training using evidence-based low-dose, high-frequency (LDHF) learning approaches and support hospital staff-led quality improvement efforts to increase the coverage of facility-based high-impact interventions, including care of the mother and newborn on the day of birth and through the first week postpartum and post abortion services.
15937276|NCT03363295|Drug|Moxifloxacin Injection|One group will receive moxifloxacin injection (0,03ml) in the anterior chamber by the end of phacoemulsification surgery
15937277|NCT03363282|Procedure|Pterygium Excision|Pterygium excision is the first step for repair
15937278|NCT03363269|Drug|ID1201|
15937279|NCT03363256|Behavioral|TES-NAV|Internet-delivered psychosocial treatment grounded in the community reinforcement approach plus contingency management adapted for AI/AN
15937280|NCT03363256|Behavioral|TAU|Standard outpatient addiction treatment
15937281|NCT03363243|Other|STOP Therapy Treatment group|Testing of the STOP Therapy protocol
15937282|NCT03363243|Other|Treatment as usual (TAU) group|Treatment as usual in the community through group therapy
15937283|NCT03363230|Behavioral|Mindfulness skills training|Mindfulness skills were taught over a 10-week period. Mindfulness skills were delivered in a weekly group-format. Participants were instructed to follow mindfulness practice at home. The treatment was focused on enhancing the patient capacity to defuse from cognitive and emotional content.
15937284|NCT03363230|Behavioral|Interpersonal Effectiveness skills training|Interpersonal effectiveness skills were taught over a 10-week period. Skills were delivered in a weekly group-format. The treatment was focused on improving interpersonal effectiveness.
15937285|NCT03363217|Drug|Trametinib|Daily administration of oral trametinib at a unique dose of 0.025 mg/kg.
15937286|NCT03363204|Device|BRUXENSE occlusal splint|Patients participating will put the BRUXENSE occlusal splint each night. During the night the device will collect data potentially related to bruxism. After each night the device will be cleaned with water and toothpaste and charged. This routine will be conducted over 10 consecutive nights.
15937287|NCT03363191|Drug|Fluticasone Furoate/Vilanterol|Fluticasone furoate/vilanterol will be supplied as inhalation powder in ELLIPTA DPI. It will contain 2 strips with 30 blisters per strip. First strip will contain fluticasone furoate 100 mcg dry white powder blended with lactose. Second strip will contain vilanterol 25 mcg dry white powder blended with lactose and magnesium stearate.
15937288|NCT03363191|Drug|Fluticasone Furoate|Fluticasone furoate will be supplied as inhalation powder in ELLIPTA DPI. It will contain a single strip with 30 blisters, containing fluticasone furoate 100 mcg dry white powder blended with lactose.
15937289|NCT03363191|Drug|Salbutamol/Albuterol|Salbutamol/albuterol will be provided to subjects to use as rescue medication on an as-needed basis.
15937290|NCT03363178|Biological|GC3107|BCG Vaccine, 0.1mL
15937291|NCT03363165|Drug|VM202|"Participants randomized to VM202 will receive calf muscle injections of VM202 to each leg with an ankle brachial index <= 0.90. Injections of VM202 are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Therefore, participants randomized to VM202 will receive 4 mgs of VM202 in each calf muscle on each treatment day. Injections are placed beginning 2 cm below the popliteal crease, and are administered in a pre-designed sequence and pattern, at a measured distance 2 cm apart.
~Note: Participants who have an ABI < 0.90 in only one leg will only receive injections in the leg with ABI < 0.90."
15937292|NCT03363165|Other|Placebo|"Participants randomized to placebo will receive bilateral calf muscle injections of placebo (the excipient buffer formulation minus the VM202). Injections of placebo are administered by a physician in a double-blinded fashion after randomization on Day 0, Day 14, Day 28, and Day 42, for a total of four treatment days. Placebo appears identical to the VM202 study drug and is administered in a pattern on the calf identical to that of the VM202 injections.
~Note: Participants who have an ABI < 0.90 in only one leg will only receive injections in the leg with ABI < 0.90."
15937293|NCT03363139|Drug|Tirosin Kinase Inhibitors|Patients that received Tyrosin Kinase inhibitors and progressed
15937294|NCT03363126|Procedure|Endonasal transsphenoidal pituitary tumor removal|Removal of pituitary tumor by transsphenoidal endonasal surgery
15937295|NCT03363113|Drug|Botulinum Toxins|Injection of botulinum toxin in the muscles affected by oromandibular dystonia
15937296|NCT03363100|Behavioral|Digital health Partnership program|The program pairs patients with their own certified diabetes educator coach who will guide the patient through a personalized program that leverages a proven educational curriculum combined with proven patient engagement methods.
15937297|NCT03363087|Device|Mapping and ablation|Ultra high density scar mapping Collection of impedance data during ablation
15937298|NCT03363087|Device|Mapping|Omnipolar mapping of left atrial scar and pulmonary vein isolation lines
15937299|NCT03363074|Device|Orthotic Insole|A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole,and 3mm,15 Shore A hardness ethyl vinyl acetate was used for covering.Orthotic insoles have been emplemented in a pair of sports shoes.
15937300|NCT03363074|Device|Low-Level Laser|A low density laser with a power density of 0.05-0.10 (w / cm2), a therapeutic dose of 0.7-7 (j / cm 2) of gallium-arsenic 904 nm will be applied. It will be 3 administered times a week for 5 weeks. Laser treatment will be applied along the tibialis posterior tendon. 3 different point (proximal tibial tendon, distally tibial tendon and posterior medial malleol) applications will be done.
15937301|NCT03363048|Behavioral|Restricted|Certain foods and beverages are not allowed to be purchased with food benefit dollars.
15937302|NCT03363048|Behavioral|Restriction plus Incentive|Certain foods and beverages are not allowed to be purchased with food benefit dollars; 30% of the total dollars spent toward the purchase of certain foods result are added to their food benefit dollars.
15937306|NCT03363022|Drug|Standard Medical Treatment|Standard Medical Treatment includes antibiotics,CRRT (Continuous Renal replacement Therapy),Liver Dialysis.
15937307|NCT03363022|Other|Fecal Microbiota Transplant|"Fecal Microbiota Transplant Stool specimen (preferably Bristol Stool Type 3 or 4) with a weight of ∼50 g will be considered adequate.
~250 mL sterile normal saline will be added to the stool sample and homogenized with a blender for 2-4minutes in pulses of 30 seconds with 10 seconds wait in between each pulse.
~Enema to be held for 30 minutes."
15937308|NCT03363022|Other|Placebo|Placebo will be identical and non medicinal to the Fecal Microbiota Transplant
15937309|NCT03363009|Device|Optimized group|The data provided by the connected devices is analyzed daily; the patient receives a phone call in case of no realization of the objectives.
15937310|NCT03363009|Device|Control group|Data will be recorded but not analyzed daily during the period of participation. The patient receives a phone call one time a week to answer possible questions and modify the prescription of physical activity if need.
15937403|NCT03362281|Drug|Ilaprazole tablet|Since 4th day, those patients were changed to take oral ilaprazole tablets 10mg each day till 30th day
15937311|NCT03362996|Dietary Supplement|Freshly-Pressed Extra Virgin Olive Oil|Dietary Supplement: Freshly-pressed extra virgin olive oil Freshly-Pressed Extra Virgin Olive Oil Aluminum bottle with 500 ml of freshly-pressed extra virgin olive oil 1 bottle per 10 days
15937312|NCT03362996|Combination Product|extra virgin olive oil|Extra Virgin Olive Oil Aluminum bottle with 500 ml of freshly-pressed extra virgin olive oil 1 bottle per 10 days
15937313|NCT03362996|Other|mediterranean diet|50 patients that will have the same dietary habits and a Mediterranean dietary protocol
15937314|NCT03362983|Other|CareHND|Multidisciplinary, integrated, person-centered care at the integrated HND-clinic
15937315|NCT03362970|Device|BioFire Gastrointestinal Panel FilmArray®|The BioFire Gastrointestinal Panel FilmArray® is a multiplexed nucleic acid (NA) based device that simultaneously identifies 22 enteric pathogens. It specifically tests for the presence of Shiga toxin and for O157. It requires 2 minutes of hands-on-time, returns results in ~2-3 hour, and is Health Canada and Food and Drug Administration approved. The device, which has been validated, hopefully will enable the early identification of infected children and initiation (or withholding) of interventions directed by previously unavailable clinical data. It will enable us to bring a precision medicine approach into ED care.
15937316|NCT03362970|Other|Standard of Care|Standard practices for children with hematochezia upon the discretion of the treating physician. If investigations are ordered, results have a turn-around time up to 72 hours.
15937317|NCT03362957|Device|Geniculate Artery Embolization|Gel-Bead Microspheres will be used for geniculate artery embolization (GAE) in subjects with knee osteoarthritis.
15937318|NCT03362957|Diagnostic Test|Sham Procedure|Patients will receive a sham procedure, which will include a diagnostic angiogram
15937319|NCT03362944|Behavioral|Active Music Therapy|The intervention consists of a standardized series of Music Therapy tasks, all based at a constant rhythmic pulse.
15937320|NCT03362944|Behavioral|Passive Music Therapy|The intervention consists of a series of recorded listening tracks, matched in style to the active intervention, all based at a constant rhythmic pulse.
15937321|NCT03362931|Device|XEN45|XEN45 unilaterally implanted in the study eye
15937322|NCT03362918|Behavioral|High Intensity Interval Training|"The exercise prescription is as follows:
~Type: High-Intensity Interval Training on a treadmill, elliptical trainer or cycle ergometer.
~Intensity: 30 seconds of high-intensity alternating with 90 seconds of low intensity for a total of 10 cycles
~High intensity for most individuals will occur at approximately 90% of maximum heart rate. Using the rating of perceived exertion scale, participants should be exercising at a 9/10, which is very difficult to maintain the intensity and results in only being able to speak a few words at a time.
~Low intensity is defined as light activity and rated as 2-3/10 on the rating of perceived exertion scale. Participants should be able to carry on a conversation and maintain the pace for hours.
~Duration: 30 minutes Frequency: 3 times per week"
15937323|NCT03362918|Behavioral|Continuous Aerobic Exercise Training|"The exercise prescription for the continuous aerobic exercise group is as follows:
~Type: Aerobic exercise including walking, running, cycling or using the elliptical trainer.
~Intensity: Moderate intensity, defined as 50-60% of the participant's maximum heart rate. On the rating of perceived exertion scale, this corresponds with a 4-6/10, which allows participants to hold a conversation while breathing heavily.
~Duration: 50 minutes Frequency: 3 times per week"
15937324|NCT03362905|Drug|Lidocaine topical|Local anesthetic for reduction of IUD associated pain
15937325|NCT03362853|Drug|Nemonoxacin 500Mg Capsule|Receive a single dose in a fasting state
15937326|NCT03362853|Drug|Moxifloxacin 400Mg Tablet|Receive a single dose in a fasting state
15937327|NCT03362853|Drug|Nemonoxacin 750Mg Capsule|Receive a single dose in a fasting state
15937328|NCT03362853|Drug|Placebo oral capsule|Receive a single dose in a fasting state
15937329|NCT03362840|Behavioral|Early Start Denver Model|The ESDM is a manualized comprehensive treatment model for young children (12-48 months). In the preschool based ESDM, learning objectives are guided by the ESDM curriculum checklist, which includes developmental skills in language, play, motor skills, personal independence, imitation and cognition. The objectives are monitored for progress during each session The sessions are conducted according to ESDM principles, and include weekly parent-coaching session, in which parents observe the therapist interact with the child while applying various teaching techniques, and then implement these techniques during the interaction with their child. Additionally, parents get acquainted with the daily objective sheet and are encouraged to work on these objectives at home as well. Finally, in this model, therapist adherence to the ESDM practices are monitored according to the ESDM fidelity rating system
15937330|NCT03362840|Behavioral|Eclectic preschool intervention|"The eclectic approach consists of a combination of methods from several treatment-models. Individualized educational plans are based on multi-disciplinary assessment, and include objectives in several domains - communication, social-skills, play, emotional adjustment, adaptive daily skills, motor skills and cognition. They are presented to parents at the beginning of the year and are reviewed by the staff three times a year.
~Parents attend by-weekly counseling-sessions with a professional in order to receive input regarding their child's progress, and discuss issues concerning their child's functioning. All staff members receive supervision at various intensities. However, these usually do not adhere to a single structure and are not guided by official fidelity criteria."
15937331|NCT03362827|Other|Chronic low back pain patients|People must have experienced low back pain for at least 3 months and have reported a minimal pain level of 30 (pain threshold) on the 0-100 pain numerical rating scale (NRS) in the last 7 days.
15937332|NCT03362827|Other|Subjects without chronic low back pain|These participants must not have presented episodes of low back pain for more than 7 days in the last 12 months.
15937333|NCT03362814|Drug|Ravidasvir|Ravidasvir 200mg tablet administered orally once daily
15937334|NCT03362814|Drug|Danoprevir|Danoprevir 100mg tablet administered orally twice daily
15937335|NCT03362814|Drug|Ritonavir|Ritonavir 100mg tablet administered orally twice daily
15937336|NCT03362814|Drug|Ribavirin 100 MG|Ribavirin tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations(<75kg = 1000mg and ≥75kg = 1200mg)
15937337|NCT03362814|Drug|Ravidasvir Placebo|Ravidasvir Placebo tablet administered orally once daily
15937338|NCT03362814|Drug|Danoprevir Placebo|Danoprevir Placebo tablet administered orally twice daily
15937339|NCT03362814|Drug|Ritonavir Placebo|Ritonavir Placebo tablet administered orally twice daily
15937482|NCT03361605|Drug|Propofol|Propofol administration
15937340|NCT03362814|Drug|Ribavirin Placebo|Ribavirin Placebo tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations(<75kg = 5 tablets and ≥75kg = 6 tablets)
15937341|NCT03362801|Diagnostic Test|sarcopenia and mobility measurement|"walking speed, grip strength and BIA. QAPPA questionnaire (validated in French in the elderly) and the objective measurement of the time of activity and rest on a week per wrist actimeter.
~Comprehensive Geriatric Assessment"
15937342|NCT03362788|Drug|VKA|VKA plus a P2Y12 inhibitor (clopidogrel 75mg or ticagrelor 90mg twice daily) and/or aspirin ≤100mg daily.
15937343|NCT03362788|Drug|NOAC|NOAC plus a P2Y12 inhibitor (clopidogrel 75mg or ticagrelor 90mg twice daily) and/or aspirin ≤100mg daily.
15937344|NCT03362775|Drug|Propofol|Target-controlled infusion of propofol with an effect-site concentration of 0.0 µL/mL; 0.5 µL/mL and 1.0 µL/mL.
15937345|NCT03362762|Other|Description of plans insuliniques used in Guadeloupe in the type 2 diabetes and the characteristics of the handled patients:|The physician or the endocrinologist will see the patient during his consultation. The pharmacist will see the patient when he goes to the pharmacy for an insulin treatment. In each case, the patient will be informed about the study, about the medical data that will be collected anonymously. The date will be strictly confidential and under medical secrecy. Then the patient will meet the physician during another consultation at the University Hospital Center of Guadeloupe, in order to collect information's on a questionnaire. Otherwise, the physician can meet the patient at his home, in case he can't move to the University Hospital Center of Guadeloupe.
15937346|NCT03362749|Other|RFA, MWA, cryo and IRE|local tumor ablation
15937347|NCT03362736|Drug|Ustekinumab|All participants will receive a single intravenous (IV) tiered dose of ustekinumab based on body weight at Week 0 (participants less than or equal to [<=] 55 kilogram [kg] will receive 260 milligram [mg] ustekinumab; > 55 kg to <= 85 kg will receive 390 mg ustekinumab; and > 85 kg will receive 520 mg ustekinumab infusion) during induction period. After the IV induction dose, all participants will receive the first maintenance dose of 90 mg ustekinumab subcutaneous (SC) injection 8 weeks later (Week 8). The participants with adequate response based on the physician's judgement will be subsequently treated with 90 mg ustekinumab SC injection with every 12 weeks through Week 80 and participants with an inadequate response to ustekinumab dosing every 12 weeks based on the physician's judgement will be subsequently treated with 90 mg of ustekinumab every 8 weeks through Week 80.
15937348|NCT03362723|Drug|Idasanutlin|Participants will receive one 300-mg dose of each of the four different oral tablet formulations of idasanutlin (tablet A [reference], B, C, D) during Cycle 1, in the order specified for their assigned treatment arm (Treatment Sequence 1-4). Participants who enter the optional treatment extension phase will receive the reference tablet formulation of idasanutlin, as specified in the Optional Treatment Extension Arm description.
15937349|NCT03362710|Diagnostic Test|simplified tools|"Skin temperature on the back of the foot with infra-red thermometry
~Toe saturometry
~ABI with an automatic sphygmomanometry
~Skin Recoloration time at the foot"
15937350|NCT03362697|Dietary Supplement|Probiotics|The Probiotic group will receive Sachet 1 - contains an instant cranberry drink, consisting of xylitol, monosodium citrate, cranberry aroma, cranberry extract, grape-skin extract, xanthan gum, acesulfame potassium and zinc gluconate and Sachet 2 - contains a total of 5*10^8 CFU of Lactobacillus reuteri DSM 16666/ATCC 55845 & Lactobacillus reuteri DSM 17938, mixed with maltodextrin. Both Sachets should be administered Day 1-14, twice per day This group will also receive for Placebo for Antibiotic treatment day 1-7, twice per day
15937351|NCT03362697|Drug|Antibiotics|Patient in this group will receive for 7 days Amoxicillin + clavulanic acid (500 mg twice daily) for seven days in patients with negative nitrites in dipstick or oral nitrofurantoin (200mg twice per day) for patients with positive nitrates in dipstick. This group will also receive for placebo for probiotics 2 sachets for 14 days
15937352|NCT03362684|Drug|Cetuximab|Cetuximab every 2 weeks
15937353|NCT03362684|Drug|FOLFOX|FOLFOX-4 every 2 weeks
15937354|NCT03362671|Device|Implant Supported Mandibular Advancement Oral Appliance|This device is a novel oral appliance that attached to orthodontic mini implants in the jaw and is designed to keep the jaw in an advanced position, opening the upper airway during sleep.
15937355|NCT03362671|Device|Orthodontic Mini Implant|Small titanium devices that are fixed to the bone for the purpose of enhancing anchorage of other orthodontic devices.
15937356|NCT03362632|Drug|Antibiotics|This is an observation study, no specific antibiotics will be indicated during treatment.
15937357|NCT03362619|Biological|CC-EIEs|2 to 4 infusions, once a week, for 1x10^5~1x10^7 CTLs/kg via IV, abdominal cavity or intratumoral injection each time
15937358|NCT03362606|Biological|OC-CTLs|2 to 4 infusions, once a week, for 1x10^5~4x10^6 CTLs/kg via IV, abdominal cavity or tumor injection each time
15937359|NCT03362593|Drug|MEDI7219|Experimental Drug
15937360|NCT03362593|Drug|Placebo|Placebo
15937361|NCT03362593|Drug|Formulation without Active Drug|Formulation without Active Drug
15937362|NCT03362580|Device|Slit lamp examination|The slit lamp is an instrument consisting of a high-intensity light source that can be focused to shine a thin sheet of light into the eye.Examination performed without pupil dilatation.
15937363|NCT03362580|Device|Undilated 7-field color fundus photography|Undilated 7-field color fundus photography with Cobra fundus camera. The examination will be done without pupil dilatation; but in case of very small pupils one drop of tropicamide will be instilled, after anterior segment observation with the slit lamp. Two ophthalmologists will assess fundus photos and OCT (Spectral domain optical coherence tomography) frames, to determine whether or not an ERM is present.
15937364|NCT03362580|Device|Color scan|Multicolor photo. The examination will be done without pupil dilatation; but in case of very small pupils one drop of tropicamide will be instilled, after anterior segment observation with the slit lamp.
15937365|NCT03362580|Device|Spectral domain optical coherence tomography|Spectral domain optical coherence tomography (OCT) with Heidelberg Retina Tomography device. The examination will be done without pupil dilatation; but in case of very small pupils one drop of tropicamide will be instilled, after anterior segment observation with the slit lamp.Two ophthalmologists will assess fundus photos and OCT frames, to determine whether or not an ERM is present.
15937366|NCT03362567|Other|Sustained Natural Apophyseal Glides|Subjects in SNAGS group were treated with sustained natural apophyseal glides, twice weekly for six weeks
15937367|NCT03362567|Other|Mechanical Cervical Traction|subjects in MCT received mechanical cervical traction, for 15 minutes each session twice in a week for six weeks
15937368|NCT03362554|Behavioral|Controlled diet and exercise.|"The intervention will involve 3 weeks of a diet and exercise program designed to cause a net energy decrease of 7000 kcal/week compared to habitual behaviour. This will be achieved through:
~Five exercise sessions per week at 70% VO2 max, using 400 kcal per session.
~Reduction of their standard diet by 5000 kcal per week
~Before and after this intervention period participants will take part in a trial day which includes measurement of body composition (using DEXA) and blood sugar control (oral glucose tolerance test). Samples of blood, adipose, skeletal muscle and faeces will also be taken."
15937369|NCT03362541|Behavioral|MS INFoRm|MS INFoRm incorporates principles of self-management and adult learning theory. The contents address the sources of fatigue, ways of monitoring fatigue, and strategies to reduce fatigue.
15937370|NCT03362541|Behavioral|Usual Care Control Group|The usual care webpage will contain content from widely available resources about MS fatigue.
15937371|NCT03362528|Device|WM3.4NR|Investigational Medical Device collecting spectral raman data from tissue.
15937372|NCT03362515|Drug|Furosemide|furosemide
15937373|NCT03362515|Drug|Placebo|placebo
15937374|NCT03362502|Genetic|PF-06939926|"Recombinant adeno-associated virus, serotype 9 (AAV9) carrying a truncated human dystrophin gene (mini-dystrophin) under the control of a muscle-specific promoter.
~Subjects will receive a single intravenous infusion of one of 2 dose levels."
15937375|NCT03362489|Procedure|IVF / IVF-ICSI|"In the IVF arm, oocyte retrieval is performed 36 hours after the HCG injection, in the operating room, under transvaginal ultrasound guidance, under local or general anesthesia. The procedure lasts about 20 minutes and the patients are discharged on the same day. The oocytes retrieved from the follicles are transported immediately to the lab for fertilization with the partner's sperm. Fertilization is done either via conventional IVF, or via ICSI, depending on the indication. Embryos are later transferred into the uterus on day 3 or day 5, under ultrasound guidance, in the outpatient department."
15937376|NCT03362489|Procedure|IUI|"In the conversion to IUI arm, IUI is performed 24 to 36 hours after ovulation trigger. The partner provides the sperm on site on the morning of the insemination, which is performed in the outpatient department."
15937377|NCT03362476|Behavioral|Computer-based alcohol reduction intervention|Brief computer-based version of cognitive behavioral therapy (CBT) used in conjunction with standard clinical care for current substance users. Modules and follow up assignments focus on key concepts in substance use, including cravings, problem solving and decision making skills. The multimedia presentation, based on elementary level computer learning games, requires no previous experience with computers.The intervention was adapted to be linguistically, gender- and HIV/HCV-appropriate for Russian women living with HIV/HCV.
15937378|NCT03362476|Behavioral|Standard-of-care|Routine counseling to avoid alcohol and drugs.
15937379|NCT03362463|Other|Non-Interventional Study|Non-Interventional Study
15937380|NCT03362450|Other|Fetal ultrasound during the second or third trimester/ Postnatal surgery / Post mortem examination|Fetal ultrasound during the second or third trimester Postnatal surgery Post mortem examination
15937381|NCT03362437|Drug|BMS-986177|Form A
15937382|NCT03362437|Drug|BMS-986177|Form B
15937383|NCT03362424|Biological|Mesenchymal stem cell|Mesenchymal stem cells applies at the end of rotator cuff repair in de active group
15937384|NCT03362424|Procedure|Rotator cuff repair|Rotator cuff repair
15937385|NCT03362411|Drug|BMS-986205|Single 100 mg dose on Day 1 and Day 15
15937386|NCT03362398|Drug|Omarigliptin 25 mg|Once weekly new anti-diabetic drug approved only in Japan
15937387|NCT03362398|Drug|Trelagliptin 100 mg|Once weekly new anti-diabetic drug approved only in Japan
15937388|NCT03362385|Other|Patients with OSA based on sleep study|Polysomnography or Polygraphy
15937389|NCT03362385|Other|Patients without OSA based on sleep study|Polysomnography or Polygraphy
15937390|NCT03362372|Behavioral|Mediterranean diet counseling|"The participants of the intervention CAP will enter into an educational program to increase adherence to the DiMet that will integrate three operational components:
~Explain the particularities of DiMet and the benefits of its monitoring. It will be an individual visit of 25-30 minutes (V1) where the study variables will be collected and the medical tests will be performed and repeated annually for two years (V3 and V5).
~Clarify the doubts of the DiMet monitoring and the advice received. It will be a telephone visit to reinforce the intervention, with annual frequency, for two years (V2 and V4).
~Report on DiMet's own foods, cooking habits, adapted recipes and other related topics. It will be for access to an ad hoc designed nutrition blog."
15937391|NCT03362359|Drug|Ga-68-PSMA-11|Single administration of 150 MBq (± 50 MBq), corresponding to a mass dose of ≤ 6 µg. A 2nd administration of 150 MBq (± 50 MBq), corresponding to a mass dose of ≤ 6 µg is possible in the unlikely case of a negative histological result (i.e. no prostate-specific membrane antigen (PSMA) expression in dissected lymph nodes) to verify if PSMA PET-positive tissue as seen on day 1 has not been removed during RP with EPLND.
15937392|NCT03362346|Device|intracranial pressure monitoring|The patients may have either intracranial pressure (ICP) monitor insertion or external ventricular drainage that can be used as ICP monitor.
15937393|NCT03362333|Other|Exercise|Exercises were aimed at increasing the endurance and strength of the deep neck flexor and extensor muscles and of the scapular stabilizer muscles.
15937394|NCT03362333|Other|Pain neuroscience education|Pain neuroscience education covered the neurophysiology of pain, transition from acute to chronic pain and the nervous system ability to modulate the pain experience.
15937395|NCT03362320|Procedure|double layer fixation|
15937396|NCT03362320|Procedure|single layer fixation|
15937397|NCT03362307|Device|Low-Level Laser and Light-Emitting Diodes|Combination of Low-Level Laser and Light-Emitting Diodes were used after dental implant placement for enhancement of stability
15937398|NCT03362307|Device|Dental implant placement|A dental implant with 4.8X 10 mm (Zimmer, USA) size was placed at the posterior of the mandible
15937399|NCT03362294|Drug|GA Depot 40mg once monthly|Once-a-month long-acting intramuscular injection of 40mg Glatiramer Acetate (GA Depot)
15937400|NCT03362294|Drug|GA Depot 25mg once monthly|Once-a-month long-acting intramuscular injection of 25mg Glatiramer Acetate (GA Depot)
15937401|NCT03362281|Drug|Ilaprazole|10 mg ilaprazole daily (at day 1-3) through intravenous infusion within 30min with first dose doubling.
15937402|NCT03362281|Drug|Omeprazole|40 mg omeprazole twice daily (at day 1-3) through intravenous infusion within 30min.
15972664|NCT03092856|Biological|Anti-OX40 Antibody PF-04518600|Given IV
15937404|NCT03362281|Drug|amoxicillin and clarithromycin|The Patients who with helicobacter pylori infection were provided amoxicillin and clarithromycin as complimentary therapy for two weeks
15937405|NCT03362268|Drug|Ilaprazole|10 mg ilaprazole daily (at day 1-3) through intravenous infusion within 30min with first dose doubling. Since 4th day, those patients were changed to take oral ilaprazole tablets 10mg each day till 30th day
15937406|NCT03362268|Drug|omeprazole|40 mg omeprazole twice daily (at day 1-3) through intravenous infusion within 30min,Since 4th day, those patients were changed to take oral omeprazole tablets 20mg each day till 30th day
15937407|NCT03362255|Other|thoracic epidural catheterization|thoracic epidural catheterization with different speed of injection
15937408|NCT03362242|Drug|ARO-AAT Injection|Single or multiple doses of ARO-AAT by subcutaneous (sc) injections
15937409|NCT03362242|Other|Sterile Normal Saline (0.9% NaCl)|Calculated volume to match active comparator
15937410|NCT03362229|Procedure|Fixation|A well reduced medial malleolus fracture will undergo internal fixation, guided by the surgeon's skill and expertise
15937411|NCT03362229|Procedure|Non-fixation|A well reduced medial malleolus fracture will be left without fixation
15937412|NCT03362216|Drug|Compound Methyl Salicylate Liniment|Compound Methyl Salicylate Liniment, apply to the affected area, 3 times a day.Course of treatment: 7 days
15937413|NCT03362216|Drug|Diclofenac Sodium Liniment|Diclofenac Sodium Liniment, apply to the affected area, 3 times a day. Course of treatment: 7 days
15937414|NCT03362203|Other|Patients with chronic neck pain|Patients,aged 21-80 years, must have experienced neck pain for at least 3 months and have reported a minimal pain level of 30 (pain threshold) on the 0-100 pain numerical rating scale (NRS) in the last 7 days.
15937415|NCT03362203|Other|Subjects without chronic neck pain|Subjects,aged 21-80 years, must not have presented episodes of chronic neck pain for more than 7 days in the last 12 months.
15937416|NCT03362190|Drug|Zimura|Zimura in combination with Lucentis
15937417|NCT03362190|Drug|Lucentis|Zimura in combination with Lucentis
15937420|NCT03362151|Other|Regular pasta|Regular pasta (Approximately 42 grams carbohydrate per meal)
15937421|NCT03362151|Other|High protein pasta|High protein pasta (Approximately 38 grams carbohydrate per meal)
15937422|NCT03362151|Other|White rice|White rice (Approximately 43 grams carbohydrate per meal)
15937423|NCT03362138|Device|dermoscopy|Solely after the dermatologist has decided to biopsy a lesion and sent the patient to biopsy, a dermoscopic image is captured by a camera attached to a dermoscope.
15937424|NCT03362099|Drug|Varenicline Tartrate or bupropion|the drug treatment will be chosen related to the polymorphism. If the polymorphism is favorable to varenicline the patient will receive varenicline, If it is favorable to bupropion the patient will receive bupropion, if not favorable to varenicline and bupropion the patient will receive bupropion + varenicline. If the patient has both favorable polymorphisms he will receive bupropion. Bupropiona dosage 150 mg once a day seven days, after twice a day until complete week twelve. Varenicline dosage 0,5 mg once a day for 3 days, after this 0,5 mg twice a day until seven day .At day eight 1 mg twice a day until complete week twelve.
15937425|NCT03362073|Drug|Ketamine|"Application of ketamine using continuous intravenous infusion method during 5 days
~Ketamine 100mg/2ml + 5% Dextrose water or Normal saline 98 ml mixed fluid
~Dose schedule: 0.05mg/kg/hr -> 0.10mg/kg/hr -> … -> 0.5mg/kg/hr (increase dose at a rate of 0.05mg/kg/hr every 8 hours)"
15937426|NCT03362060|Drug|Pembrolizumab|Pembrolizumab is a monoclonal antibody checkpoint inhibitor that blocks a protein in T-cells cells called PD-1, which then allows these cells and other parts of the immune system to attack tumors
15937427|NCT03362060|Biological|PVX-410|PVX-410 is a type of vaccine composed of 4 9-amino acid peptides that may help the immune system stimulate immunity against cancer cells
15937428|NCT03362047|Drug|Riciguat Group|Patients will be administered 12 weeks Riciguat
15937429|NCT03362047|Drug|Macitentan Group|Patients will be administered 12 weeks Macitentan
15937430|NCT03362034|Device|double transfer trays|double trays one soft and one hard
15937431|NCT03362034|Device|single transfer tray|single soft tray
15937432|NCT03362021|Procedure|transvaginal oocyte retrieval|sedation for oocyte retrieval
15937433|NCT03362008|Drug|Zeropix|administration of Zeropix
15937434|NCT03362008|Drug|Champix®|administration of Champix®
15937435|NCT03361995|Device|Cooling Procedure using the ZOLL Thermogard XP3 IVTM System|Cooling Procedure with ZOLL Thermogard XP3 IVTM System before and after Percutaneous Coronary Intervention (PCI)
15937436|NCT03361995|Device|PCI|Standard of Care for PCI
15937437|NCT03361982|Other|Slow Freezing and Thawing|half of the surgically obtained testicular sperm will be frozen for 30 minutes and subsequently thawed prior to performing ICSI
15937438|NCT03361969|Drug|Estetrol|estetrol formulated in tablets
15937439|NCT03361969|Drug|Placebo Oral Tablet|placebo tablets
15937440|NCT03361956|Drug|JNJ-56136379|Participants will receive JNJ-56136379 tablet orally.
15937441|NCT03361956|Drug|Placebo|Participants will receive matching placebo tablet orally.
15937442|NCT03361956|Drug|NA (ETV or TDF)|Participants will receive NA (ETV or TDF) tablet orally as per approved label.
15937443|NCT03361930|Device|Ankle-foot orthosis|"Two custom ankle-foot orthoses for the involved lower leg; cast, rectified and fitted by same certified orthotist to reduce clinician variability.
~The cast is rectified according to the specifications of Hylton (1987) to produce tone-reducing features in the foot plate; the tone-reducing ankle-foot orthosis is manufactured on this cast. The orthotist then remodels the cast with a flat foot plate; the plain ankle-foot orthosis is then manufactured."
15937444|NCT03361917|Device|Endocuff Vision|Subjects that are randomized to undergo their colonoscopy procedure with the Endocuff Vision device will have the device placed on the colonoscope that will be used during their procedure.
15937445|NCT03361904|Procedure|Colonoscopy|Total colonoscopy : All consecutive patients who were scheduled for colonoscopy were included. Exclusion criteria were: patients scheduled for partial colonoscopy, interventional colonoscopy (for stent insertion, stenosis dilation).
15937547|NCT03361098|Other|placebo dapagliflozin|placebo tablets dapagliflozin
15937446|NCT03361891|Behavioral|WalkMORE Group|Hospitalized Internal Medicine patients will walk with trained volunteer coaches twice daily until hospital discharge
15937447|NCT03361878|Drug|Metformin Hydrochloride|Single dose of 500mg oral metformin
15937448|NCT03361865|Drug|Pembrolizumab|Pembrolizumab administered intravenously every 3 weeks.
15937449|NCT03361865|Drug|Epacadostat|Epacadostat administered orally twice daily.
15937450|NCT03361865|Drug|Placebo|Matching placebo administered orally twice daily.
15937454|NCT03361839|Diagnostic Test|endometrial biopsy|endometrial biopsy for genetic study of endometrial receptivity
15937455|NCT03361826|Device|MagPro MST with Cool TwinCoil|MST treatments will be administered using the MagPro MST with Cool TwinCoil. The investigators will evaluate the effectiveness of MST for reducing suicidality and depressive symptoms in an open-label clinical trial of up to 15 treatment sessions. Moderate-to-highly suicidal patients with BPD beginning dialectical behavioural therapy (DBT) will be recruited using a case-control design, comparing individuals receiving MST and DBT with matched patient control group receiving DBT alone.
15937456|NCT03361826|Behavioral|DBT|Dialectical behavior therapy (DBT) is a specific type of cognitive-behavioral psychotherapy developed to help better treat borderline personality disorder. Moderate-to-highly suicidal patients with BPD beginning dialectical behavioural therapy (DBT) will be recruited using a case-control design, comparing individuals receiving MST and DBT with matched patient control group receiving DBT alone.
15937457|NCT03361813|Other|trans-cutaneous ultrasound guided peritonsillar infiltration|Preoperative peritonsillar infiltration of bupivacine in tonsillectomy surgery by using the ultrasound through a transcutaneous route
15937458|NCT03361813|Other|trans-oral ultrasound guided peritonsillar infiltration|Preoperative peritonsillar infiltration of bupivacine in tonsillectomy surgery by using the ultrasound through a trans-oral route
15937459|NCT03361800|Drug|Entinostat|oral drug, 5mg tablet given once weekly x 2 doses
15937460|NCT03361787|Behavioral|"Parentship- a multi dimensional intervention program to improve parental resilience"|"Parentship is a multi dimensional intervention program to improve parental resilience and adolescent participation using the OPC model."
15937461|NCT03361774|Drug|Dentifrice containing 5% w/w KNO3 and 0.454% w/w SnF2 (1100 ppm fluoride).|"Participants will be instructed to dose the toothbrush with a strip of dentifrice containing 5% w/w KNO3 and 0.454% w/w SnF2 (1100 ppm fluoride) (a full brush head) and brush for at least 1 timed minute, twice daily (morning and evening), making sure to brush all sensitive areas of their teeth.
~Participants will be permitted to rinse with tap water post-brushing if they wish to."
15937462|NCT03361774|Drug|Dentifrice containing 0.454% w/w SnF2 (1100 ppm fluoride).|Participants will be instructed to dose the toothbrush with a strip of dentifrice containing 0.454% w/w SnF2 (1100 ppm fluoride) (a full brush head) and brush for at least 1 timed minute, twice daily (morning and evening), making sure to brush all sensitive areas of their teeth. Participants will be permitted to rinse with tap water post-brushing if they wish to.
15937463|NCT03361761|Other|Health education program|formalized/official Health education program
15937464|NCT03361761|Other|Health education program|non formalized/official Health education program
15937465|NCT03361748|Biological|bb2121|: bb2121 consists of autologous T lymphocytes transduced with an anti-BCMA02 CAR lentiviral vector to express a chimeric antigen receptor targeting the human B cell maturation antigen (anti-BCMA CAR).
15937466|NCT03361735|Drug|Leuprolide Acetate|Intramuscular or subcutaneous injection
15937467|NCT03361735|Drug|Goserelin Acetate|Subcutaneous injection
15937468|NCT03361735|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15937469|NCT03361735|Radiation|Radium Ra 223 Dichloride|Given IV
15937470|NCT03361735|Other|Laboratory Biomarker Analysis|Correlative studies
15937471|NCT03361735|Drug|Degarelix|Subcutaneous injection
15937472|NCT03361709|Drug|Dexamethasone|Dexamethasone will be injected intracamerally at the conclusion of Phacoemulsification
15937473|NCT03361709|Drug|Saline Solutions, Intraocular|Only saline will be injected intracamerally at conclusion of Phacoemulsification
15937474|NCT03361696|Other|Help to use the Interface System of Communication and Control of the Environment|the occupational therapist and the ergonomics engineers at the rate of 4 sessions per patient for periods of 2 to 3 hours help patient to use use the Interface System of Communication and Control of the Environment
15937475|NCT03361683|Device|High-flow nasal oxygen|Randomized patients will receive oxygen through a high nasal flow device capable of delivering humidified, heated air at an output rate of 40 L/min
15937476|NCT03361683|Device|Venturi mask|Randomized patients will receive oxygen through a Venturi mask at an air flow of 15 L/min
15937477|NCT03361670|Other|Observational Study|
15937478|NCT03361644|Behavioral|High-Intensity Interval Training|Participants assigned to HIIT will participate in treadmill exercise in intervals consisting of 1 minute intervals of challenging intensities with recovery periods in between, gradually increasing the number of intervals over the course of the study.
15937479|NCT03361644|Behavioral|Moderate-Intensity Continuous Training|Participants assigned to CMIT will participate in constant moderate intensity treadmill exercise, gradually increasing the duration of the exercise over the course of the study.
15937480|NCT03361631|Drug|Autologous Bone Marrow derived Mesenchymal Stem Cells|Information visit (time 1) Inclusion visit (time 2) Bone marrow extraction (time 3) Treatment and culture of MSC (time 4) Intra-cavernosal injection of autologous MSC (time 5) Follow-up 1 (time 6): control / tolerance visit (andrological clinical examination, EHS and and IIEF-5), 2 weeks after injection; Follow-up 2 (time 7): 12-week evaluation of treatment response: andrological clinical examination, IIEF-5 and EHS score determination & Pharmaco-Doppler; Follow-up 3 (time 8): 24-week evaluation of the response to treatment: andrological clinical examination, determination of IIEF-5 and EHS scores & Pharmaco-Doppler
15937481|NCT03361618|Dietary Supplement|Zinc Sulfate|The subfertile group treated with zinc sulfate, every participant took two capsules of zinc sulfate per day for three months (each one 220 mg).
15937483|NCT03361592|Procedure|Spinal Manipulative Therapy|Lumbar (SMT) was performed using Diversified techniques, aiming to correct vertebral dysfunctional lumbar segments. Participants were asked to lay down prone on, to perform spinal motion palpation analysis was in order to evaluate the presence of dysfunction in vertebral segments of lumbar spine.
15937484|NCT03361592|Procedure|SHAM|"The SHAM (pre-load positioning SMT) was performed with participant body positioning in the lateral position, as the SMT intervention. The doctor followed the participant through the same position of (SMT) intervention, using the maintenance of set-up position, but no manipulative thrust was delivered. The therapist applied minimal pressure and slid their hands across the skin to mimic the manipulative trust. The position was maintained 30 seconds on each side, and none of force or researcher body weight were putted in this procedure, only minimal pressure common to stabilize the set up position of (SMT)."
15937485|NCT03361579|Other|Education|c.p. intervention description
15937486|NCT03361566|Behavioral|physical activity|3 different levels of physical activity
15937487|NCT03361566|Behavioral|energy intake|4 different types of energy intake
15937488|NCT03361540|Drug|ASP8302|ASP8302 will be administered orally.
15937489|NCT03361540|Drug|Placebo|Placebo will be administered orally.
15937490|NCT03361527|Other|binaural beamformer|Each study participant will use an Advacned Bionics Naida CI Q90 loaner processor during the course of the study, an Advanced Bionics MyPilot remote control and- if applicable- a SmartPhone. the processors will be programmed with SoundWave and BEPSnet.
15937491|NCT03361514|Behavioral|Supported Protocolized Discontinuation (SPD)|Patients who choose to discontinue their medication will make a personal tapering schedule with their GP based upon a discontinuation protocol with tapering suggestions. The protocol offers suggestions to taper within a maximum of 6 months describing all types of available dosages per antidepressant so individualized schedules can be constructed. In addition, they will be offered supportive meetings with the GP's mental health assistant. The assistant will receive basic information about discontinuation guidance, i.e. the information brochure, decision aid, discontinuation protocol and a short guideline how to organise consultations.
15937492|NCT03361514|Behavioral|Mindfulness Based Cognitive Therapy (MBCT)|In addition to the SPD patients are offered Mindfulness Based Cognitive Therapy (MBCT) in homogeneous groups of patients willing to withdraw from their medication. MBCT will be offered according to the treatment protocol developed for recurrent depression, adaptated to the specific needs of patients discontinuing their antidepressant medication. The mindfulness courses will be provided by teachers qualifying the advanced criteria of the Association of Mindfulness Based Teachers in the Netherlands and Flanders. All teachers will receive additional training in using the specific study protocol at the start of the project.
15937493|NCT03361501|Drug|CaPre|4 x 1 g capsules administered orally once daily for 26 weeks
15937494|NCT03361501|Drug|Placebo|4 x 1 g capsules administered orally once daily for 26 weeks
15937495|NCT03361488|Other|Trained anesthesiogist|
15937496|NCT03361475|Behavioral|SME App|"The features in the App could be used in the future by linking with some platforms / existing services so that more SME messages can be sent to the students for sharing. One school workshop will be held to promote SME and introduce the function of SME App for students to download and use immediately to connect family members.
~SME App promotes SME via:
~Express gratitude to family members (sharing)
~Deliver positive messages regularly (mind)
~Record physical and other joyful activities (enjoyment)
~Increase knowledge and understanding of adolescent mental health problem (in particular the anxiety disorders)"
15937498|NCT03361449|Other|Flamingo exercise|Flamingo exercise
15937499|NCT03361449|Other|training with kinesthetic ability trainer|training with kinesthetic ability trainer
15937500|NCT03361436|Drug|Eribulin Mesylate|Given IV
15937501|NCT03361436|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
15937502|NCT03361436|Other|Laboratory Biomarker Analysis|Correlative studies
15937503|NCT03361436|Other|Quality-of-Life Assessment|Ancillary studies
15937504|NCT03361436|Other|Questionnaire Administration|Ancillary studies
15937505|NCT03361436|Procedure|Therapeutic Conventional Surgery|Undergo surgery
15937506|NCT03361423|Device|Nerivio Migra-1 active device|"The device is placed on the subject upper arm. when activated, stimulus is applied to influence the subject's perception of a painful stimulus, delivered (or originating) at a different location. Based on diffused noxious inhibitory control mechanism, sometimes referred to as pain inhibits pain principle, conditioned pain modulation evokes an endogenous analgesic mechanism. The modulatory effect is over the whole body, and can be induced anywhere in the body. This approach allows applying the conditioning stimuli away from the painful site."
15937507|NCT03361423|Device|Nerivio Migra-1 Sham device|The device is placed on the subject upper arm. when activated, the stimulus is applied is not sufficient to influence the subject's perception of a painful stimulus.
15937508|NCT03361410|Dietary Supplement|Grape Powder|36 g of grape powder to be taken twice/day (total of 72 g/day) for 12 months
15937509|NCT03361410|Dietary Supplement|Placebo Powder|36 g of placebo powder to be taken twice/day (total of 72 g/day) for 12 months
15937510|NCT03361397|Drug|Lidocaine Hydrochloride|Lidocaine hydrochloride will be used via mask nebulizer before LMA insertion
15937511|NCT03361397|Drug|Distilled Water|Distilled Water will be used via mask nebulizer before LMA insertion
15937512|NCT03361384|Drug|Alcohol|
15937513|NCT03361384|Other|Placebo (non-alcoholic beverage)|
15937514|NCT03361371|Device|Battery operated nasal aspirator|Suctioning prior to every feed with battery operated nasal aspirator for three days in addition to the routine standard of care.
15937515|NCT03361371|Device|Suction bulb|Suctioning prior to every feed with bulb nasal aspirator for three days in addition to the routine standard of care.
15937516|NCT03361345|Drug|Tranexamic Acid|Topical tranexamic acid in cream form applied to dark spots on right side of face.
15937596|NCT03360682|Drug|Dolutegravir 50 mg|Dolutegravir 50 MG/day (48 weeks)
15972665|NCT03092856|Drug|Axitinib|Given PO
15937517|NCT03361345|Drug|Vehicle|The Vehicle is going to be a cream without any active medication that will be applied as a control substance for the topical tranexamic acid cream, and will be applied to the contralateral side of the face.
15937518|NCT03361332|Other|Behavioral and fMRI|Subjects and patients will perform temporal-judgment-tasks (considered an indirect measure of the sense of agency) in an event-related fMRI setting. In the first task, they will hear a sound either caused by a voluntary key press or by the passive displacement of the same finger by the experimenter. Following each trial, subjects will estimate the delay between the finger movement and the subsequent sound, which will be presented at variable latencies after the key press. There will be also control-trials characterized by the active or passive movement with a subsequent sound presented with a delay that excludes causality inferences.
15937519|NCT03361319|Drug|Vargatef|small molecule triple kinase inhibitor
15937520|NCT03361319|Drug|Abraxane|Paclitaxel formulated as albumin bound nanoparticles
15937521|NCT03361319|Other|placebo|Placebo in place of Ninedanib
15937522|NCT03361306|Drug|Elotuzumab|Experimental
15937523|NCT03361293|Device|Active tDCS|Active Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (active mode)
15937524|NCT03361293|Behavioral|Cognitive training|BrainHQ Computerized cognitive training
15937525|NCT03361293|Device|Sham tDCS|Sham Transcranial Direct Current Stimulation (tDCS) administered with a Neuroelectrics StarStim Enobio cap system (sham mode)
15937526|NCT03361280|Drug|Beta blocker|Beta blockers are administered as described in arms.
15937527|NCT03361267|Diagnostic Test|Helicobacter pylori PCR test|Clarithromycin resistance (-) Triple therapy (rabeprazole 20 mg bid, amoxicillin 1000mg bid, clarithromycin 500mg bid) for 7 days Clarithromycin resistance (+) Bismuth containing quadruple therapy (rabeprazole 20 mg bid, metronidazole 500 mg tid, bismuth 300 mg qid, tetracycline 500mg qid) for 7 days
15937528|NCT03361267|Diagnostic Test|CLO test|CLO test : negative --> drop out CLO test : postive --> bismuth containing quadruple therapy
15937529|NCT03361254|Biological|cryopreservation|cryopreservation to every patient with an indication of ECP for acute or chronic GVHD in Nancy Hospital for 18 months
15937530|NCT03361241|Other|No Physiotherapeutic Intervention|"Experimental group will perform a balance training program in a virtual environment (using a gaming system with balance board device - eight games of Nintendo Wii Fit®, for 14 sessions) without verbal/manual physiotherapeutic intervention.
~Initially, instructions about the rules and strategies of how to play the game and control the avatar will be provided.
~Then the patient will be invited to start the game, and in the two attempts of the training no manual or verbal assistance will be provided. Physiotherapist participation during training will be restricted to ensuring patient safety, providing motivational verbal stimuli, and replicating the feedback provided by the game at the end of each attempt."
15937531|NCT03361241|Other|Physiotherapeutic Intervention|Control group will perform a balance training program in a virtual environment (gaming system with balance board device - eight games of Nintendo Wii Fit®, for 14 sessions) with verbal and manual physiotherapeutic intervention. Initially, instructions about the rules and strategies of how to play the game and control the avatar will be provided. Then the patient will be invited to start the game, and in the first attempt of the training physiotherapist will provide manual and verbal assistance, providing corrections on movement (avoiding compensatory movements). In the second attempt, no manual or verbal assistance will be provided (only ensuring patient safety, providing motivational verbal stimuli), allowing the patient to organize his or her performance.
15937532|NCT03361228|Drug|INCB001158|Phase 1: INCB001158 administered orally twice daily at the protocol-defined dose. Phase 2: INCB001158 administered orally twice daily at the recommended dose from Phase 1.
15937533|NCT03361228|Drug|Epacadostat|Epacadostat at the protocol-defined dose administered orally twice daily.
15937534|NCT03361228|Drug|Pembrolizumab|Pembrolizumab at the protocol-defined dose administered intravenously every 3 weeks.
15937535|NCT03361202|Other|blood sampling|"atrial fibrillation group:before Percutaneous Occluding of the Left Atrium, at hospital discharge and at J45 follow up
~control group:before coronary angiography and at hospital discharge."
15937536|NCT03361189|Device|Closed loop stimulation|Closed loop stimulation is a physiologic, rate-adaptive pacing algorithm.
15937537|NCT03361176|Drug|Injectable sodium deoxycholate|Kybella(TM) alone: 2 mg/cm2 of Kybella(TM) with 0.2 mL of 1% lidocaine with no epinephrine plus 0.2cc saline to the non-TMC group to maintain equal concentrations in each injection so that the final Kybella concentration per vial will be 10mg/1.2mls or 1.6mg per 0.2 cc injection point will be delivered in up to 50 injections spaced 1.0 cm apart at 0.2 mL/injection for a total maximal dose of up to 100 mg of SDOC.
15937538|NCT03361176|Combination Product|Injectable sodium deoxycholate with Triamcinolone acetate|Kybella(TM)+TMC at 1.0 mg/mL: 2.0 mL of 2 mg/cm2 of Kybella(TM) will be mixed with 0.2 mL of 10 mg/mL of triamcinolone acetate, 0.2 mL of 1% lidocaine with no epinephrine and then delivered in up to 50 injections spaced 1.0 cm apart at 0.2 mL/injection for a total dose of up to 100 mg of SDOC using a 30 gauge (or smaller) 0.5-inch needle. The final Kybella concentration per vial will be 10mg/1.2mls or 1.6mg per 0.2 cc injection point
15937539|NCT03361163|Biological|emm75 Streptococcus pyogenes (GAS M75, strain 611024)|Direct oropharyngeal application by swab following immersion in a solution containing a specified concentration (dose) of GAS M75.
15937540|NCT03361150|Procedure|HIT|Both exercise protocol will be personalized, 3 times per week, 40-min exercise. HIT alternates a series of high-intensity bouts with relief period. MCT is continuous exercise with a constant intensity below anaerobic threshold.
15937541|NCT03361150|Procedure|MCT|Both exercise protocol will be personalized, 3 times per week, 40-min exercise. MCT is continuous exercise with a constant intensity below anaerobic threshold.
15937542|NCT03361137|Drug|Emicizumab|Emicizumab via SC injection at a loading dose 3 mg/kg once weekly for the first 4 weeks, followed by 1.5 mg/kg once weekly, or by any other approved maintenance regimen, as long as the participant continues to derive sufficient benefit. Dosing was to be adjusted if the participant had a significant change in body weight.
15937543|NCT03361124|Drug|Oxytocin|Administration of additional 20 mU Oxytocin
15937544|NCT03361098|Drug|Dapagliflozin 10mg|Dapagliflozin 10mg oral tablet once daily
15937545|NCT03361098|Drug|Exenatide|Exenatide 5 microgram b.i.d. week 1-4 Exenatide 10 microgram b.i.d. week 5-16
15937546|NCT03361098|Other|placebo exenatide|placebo b.i.d. exenatide
15937548|NCT03361085|Procedure|nvHAP Prevention Bundle|oral care, (early) mobilization, diagnosis and treatment of dysphagia, respiratory physiotherapy, stop Proton pump Inhibitors (PPI) if reasonable
15937549|NCT03361072|Dietary Supplement|Oral immunotherapy|Milk, peanut or egg oral immunotherapy
15937550|NCT03361046|Device|Transcatheter Aortic Valve-in-Valve Implantation (ViV-TAVI)|Patients with failed aortic valve bioprostheses qualified for TAVI due to coexisting illnesses
15937551|NCT03361007|Device|Transcatheter Aortic Valve Implantation (TAVI)|Patients who were disqualified from surgical cortical valve replacement by decision of the Heart Team.
15937552|NCT03360994|Other|WATChmAN Active Surveillance|WATChmAN Active Surveillance uses an electronic tool used to provide active surveillance care to testicular cancer patients. This virtual active surveillance care is delivered with an identical schedule to in-person care without the need to come into clinic.
15937553|NCT03360994|Other|In-person Active Surveillance|In-person active surveillance is the current recommended management option for all Stage I testicular cancer patients at Princess Margaret. Patients are monitored clinically with imaging and blood work, and active treatment only begins if relapse occurs.
15937554|NCT03360981|Drug|Incretins|after CABG, and epicardial tissue biopsy, patients will receive incretin therapy.
15937555|NCT03360968|Procedure|Variable-PS|Variable-PS mode switched on for 1 hour
15937556|NCT03360968|Procedure|SPN-CPAP/PS|SPN-CPAP/PS mode switched on for 1 hour
15937557|NCT03360968|Procedure|Variable-PS|Variable-PS mode switched on for 1 hour
15937558|NCT03360955|Procedure|Anesthesia|Different anesthesia technique will be compared to find out which one offers better outcome to perform ultrafast track extubation
15937559|NCT03360942|Device|SCC DBS|Deep Brain Stimulator
15937560|NCT03360929|Drug|AZD3759|Strength: 50mg/tablet, 100mg/tablet Dosage and administration: Twice daily administration under fasting state.
15937561|NCT03360916|Drug|Lipitor 20Mg Tablet|One tablet by mouth every day for 12 weeks.
15937562|NCT03360916|Drug|Lipitor 80Mg Tablet|One tablet by mouth every day for 12 weeks.
15937563|NCT03360916|Drug|Placebo|One matching placebo tablet by mouth every day for 12 weeks.
15937564|NCT03360916|Behavioral|Exercise Program|Exercise program of brisk walking and/or slow jogging on a treadmill for 90 minutes of exercise spread over 3 days during week 1, 150 minutes of exercise spread over 5 days during week 2, 225 minutes of exercise over 5 days during week 3 and for the rest of the study.
15937565|NCT03360903|Drug|Placebo|"Anesthetized volunteers will be allowed to wake after injection of saline (placebo control).
~Other Names:
~Saline"
15937566|NCT03360903|Drug|Caffeine|"Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg).
~Other Names:
~Caffeine citrate"
15937567|NCT03360890|Drug|Pembrolizumab|Pembrolizumab will be administered via IV at 200mg every three weeks. Patients will receive pembrolizumab for about 2 years.
15937568|NCT03360890|Drug|Docetaxel|Docetaxel will be administered via IV at 75mg/m2 every three weeks for 3 to 6 cycles.
15937569|NCT03360877|Other|Health-care associated infection (HCAI)|Cleaning of the child with soap and water administered by the child's accompanying person in a structure or - a cleaning of the child with chlorhexidine gluconate administered by the child's accompanying person in the other structure
15937570|NCT03360864|Other|Education program|Patient will participate to a education program.
15937571|NCT03360851|Diagnostic Test|low-dose CT|see arm/group description
15937572|NCT03360851|Diagnostic Test|PoC-PCR|see arm/group description
15937573|NCT03360838|Other|CogCheck|Performance of study participants in the application
15937574|NCT03360825|Device|TetraGraph|The TetraGraph is a dedicated neuromuscular stimulator / recorder intended to evoke, record, and analyze muscle action potentials during surgical procedures
15937575|NCT03360812|Other|Online training resource|Please see information included in the description of the intervention group.
15937576|NCT03360799|Other|Questionnaire Administration|Complete questionnaires
15937577|NCT03360786|Other|Specific intervention|Series of progressive exercises targeted at balance, adaptation, dividing attention, head on neck control, visual + education on concussion identification and concussion education
15937578|NCT03360786|Other|Control intervention|Education on concussion and concussion identification in addition to typical cardiovascular warmups
15937579|NCT03360760|Drug|Doxorubicin|60mg/m^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
15937580|NCT03360760|Drug|Cisplatin|100mg/m^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
15937581|NCT03360760|Drug|Methotrexate|High dose of methotrexate (8-12g/m^2), in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
15937582|NCT03360760|Drug|Ifosfamide|12g/m^2, in the adjuvant chemotherapy regimen for osteosarcoma in PKUPH
15937583|NCT03360760|Procedure|definitive surgery|Including limb-sparing procedure and amputation
15937584|NCT03360760|Other|pre surgical chemotherapy|chemotherapy that given before definitive surgery
15937585|NCT03360747|Drug|AKCEA-ANGPTL3-LRx|AKCEA-ANGPTL3-LRx at dose 20 mg, administered via SC injection QW.
15937586|NCT03360734|Drug|First part: Gatipotuzumab and Tomuzotuximab; Second part: Gatipotuzumab and Tomuzotuximab or anti-EGFR antibody (Cetuximab, Panitumumab or Necitumumab)|Two monoclonal antibodies, Gatipotuzumab is anti-TAMUC1, Tomuzotuximab is anti-EGFR
15937587|NCT03360721|Drug|Abiraterone Acetate|Given PO
15937588|NCT03360721|Drug|Apalutamide|Given PO
15937589|NCT03360721|Drug|Prednisone|Given PO
15937590|NCT03360708|Other|Laboratory Biomarker Analysis|Correlative studies
15937591|NCT03360708|Biological|Malignant Glioma Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccine|Given ID
15937592|NCT03360695|Other|Proactive Psychiatry Consultation (PPC)|Proactive Psychiatry Consultation and Case Management aims to improve communication among the patient, oncology team, and mental health clinicians, and increase engagement of family and community caregivers, which may help patients to receive the cancer care they need.
15937593|NCT03360695|Other|Enhanced Usual Care (EUC)|At enrollment, study staff will inform the treating oncologist of the psychiatric diagnosis and will inform the oncologist, patient, and caregiver of available psychosocial services.
15937594|NCT03360682|Drug|Lamivudine 300 MG|Lamivudine 300 MG/day (48 weeks)
15937595|NCT03360682|Drug|Abacavir 600 MG|Abacavir 600 MG/day (48 weeks)
15972666|NCT03092856|Other|Laboratory Biomarker Analysis|Correlative studies
15937598|NCT03360682|Drug|Emtricitabine 200 MG|Emtricitabine 200 MG/day (48 weeks)
15937599|NCT03360669|Other|Sequence: Clinical/Research|Participants will be assigned to a sequence of: research visit first/clinical visit second.
15937600|NCT03360669|Other|Sequence: Research/Clinical|Participants will be assigned to a sequence of: clinical visit first/research visit second.
15937601|NCT03360656|Device|Transnasal Thermal Regulating Device|Placement of transnasal thermal regulating device to reduce temperature in febrile patients for a period of 8 to 24 hours
15937602|NCT03360643|Diagnostic Test|Point-of-care ultrasound prior to radiology ultrasound|Point-of-care ultrasound performed by pediatric emergency medicine physicians prior to radiology-performed ultrasound
15937603|NCT03360643|Diagnostic Test|Radiology-performed ultrasound|Ultrasound performed an ultrasound technician and/or radiologist, and interpreted by a radiologist
15937604|NCT03360630|Biological|Anti-PD-1 plus DC-CIK|Patients will receive pembrolizumab 100mg every three weeks until disease progression, unacceptable toxicity or patient refusal. DC-CIK Immunotherapy: Mononuclear cells were collected aseptically with blood cell separator composition apheresis, and cultured DC-CIK cells for 10-14 days. Cells were infused back to the patients in 3 times via intravenous infusion .Patients will received at least 2 cycles of DC-CIK Immunotherapy along with 4 dosage of anti-PD-1 antibody treatment. If the evaluation of the treatment is partial response or stable disease, additional cycles were eligible.
15937605|NCT03360630|Biological|Anti-PD-1 alone|Patients will receive pembrolizumab 100mg every three weeks until disease progression, unacceptable toxicity or patient refusal.
15937606|NCT03360617|Device|Syringe IV Push over 2-3 minutes|IV antibiotics will be administered by Syringe IV Push over 2-3 minutes
15937607|NCT03360617|Device|Piggyback over 30 minutes|IV antibiotics will be administered by IV Piggyback over 30 minutes.
15937608|NCT03360604|Dietary Supplement|Low Glycaemic Diet|This intervention is a diet consisting of a Low GI breakfast, lunch and snack meal.
15937609|NCT03360604|Dietary Supplement|High Glycaemic Diet|This intervention is a diet consisting of a High GI breakfast, lunch and snack meal.
15937610|NCT03360591|Device|Physiologically-guided strategy|"The Angiographically-guided strategy is that of aiming the most complete degree of revascularization based on angiographic evaluation (stenting all coronary stenosis of major branches >2.5mm, with a % coronary stenosis>50% as evaluated by visual estimation.
~The Physiologically-guided strategy is that of treating only lesions with FFR ≤0.80, and leaving on optimal medical treatment lesions with FFR >0.80. The iFR values will be recorded in all patients, and verified in the core laboratory to allow a post-hoc analysis correlating the 0.80 FFR cut-off with different iFR cut-off values, and using the same study end-points.
~Particular attention will be dedicated to the eventual occurrence of clinical events in patients deferred on the bases of FFR values >0.80 that show a discrepancy with positive (<0.89) iFR values to investigate the reliability of the FFR in the aortic stenosis setting. Both groups will receive the same TAVI strategy and optimal medical therapy"
15937611|NCT03360578|Device|Zephyr BioPatch|A physiological Monitoring Device
15937612|NCT03360552|Other|Multidimensional fragility index questionnaire RAI-Home Care|Questionnaire for assessing deficits in Alzheimer's disease
15937613|NCT03360552|Other|Usual care|Usual clinical evaluation
15937614|NCT03360539|Behavioral|Nurse-Family Partnership|
15937615|NCT03360526|Device|PICSI|Semen processing is done by double layer density gradient method followed by adding Sperm to the dot of hyaluronan on the PICSI dish, within minutes the bound sperm are attached by their acrosome to the surface of the dot. (Selecting an individual bound sperm with enhanced genetic and developmental integrity ensures that the sperm selected is the optimal sperm from the sample for oocyte injection.
15937616|NCT03360526|Procedure|TESA|"Patients will undergo TESA which is performed by sticking a needle in the testis and aspirating fluid and tissue with negative pressure then examine the sample for presence of motile
~sperms followed by sample processing and oocyte injection."
15937617|NCT03360513|Other|general group|The sample comprised maxillary and mandibular dental casts of 70 Caucasian Brazilian individuals (28 men and 42 women) with an average age of 16.4 years, all of which had natural normal occlusion with at least four of the six keys to normal occlusion. 14 The first item of the first key was considered essential for sample selection(Angle Class I molar relationship). Another inclusion criterion was that individuals should be at least 15 years of age with no odontogenic abnormalities and all permanent teeth in occlusion.
15937618|NCT03360500|Other|EXERCISE PROTOCOL + CRYOTHERAPY|"Protocol: The therapeutic exercise protocol was designed according to the recommendations and guidelines of evidence-based practices and specific randomized clinical trials of physical exercise intervention for Knee osteoarthritis.
~The suggested parameters for an adequate prescription of physical exercises include the type, application method, intensity, duration, minimum number of sessions and frequency of exercises.
~Cryotherapy: Crushed ice inside two plastic bags. The positioning of the plastic bags will cover the entire knee surface (Anterior, lateral and posterior region). After the positioning of the ice bags, they will be fixed with an elastic bandage (compression). To protect the skin against frost bites, all the knee surface will be covered with a moistened operative field."
15937619|NCT03360500|Other|EXERCISE PROTOCOL|"Protocol: The therapeutic exercise protocol was designed according to the recommendations and guidelines of evidence-based practices and specific randomized clinical trials of physical exercise intervention for Knee osteoarthritis.
~The suggested parameters for an adequate prescription of physical exercises include the type, application method, intensity, duration, minimum number of sessions and frequency of exercises."
15937620|NCT03360500|Other|EXERCISE PROTOCOL + PLACEBO|"Protocol: The therapeutic exercise protocol was designed according to the recommendations and guidelines of evidence-based practices and specific randomized clinical trials of physical exercise intervention for Knee osteoarthritis.
~The suggested parameters for an adequate prescription of physical exercises include the type, application method, intensity, duration, minimum number of sessions and frequency of exercises.
~Placebo: Sand inside two plastic bags. The positioning of the plastic bags will cover the entire knee surface (Anterior, lateral and posterior region). After the positioning of the sandbags, they will be fixed with an elastic bandage (compression). All the knee surface will be covered with a moistened operative field."
15937621|NCT03360487|Radiation|Photobiomodulation in the sublingual region|In the group submitted to sublingual irradiation, disposable plastic wrap will cover the application pen for the purposes of hygiene, and irradiation will take 10 minutes.
15937782|NCT03359174|Drug|All-trans retinoic acid|Fixed low dose of ATRA 10 mg twice daily for 24 weeks.
15937622|NCT03360487|Radiation|Photobiomodulation in the spinal cord|Transcutaneous irradiation of the spinal cord will be performed on segments corresponding to the nerve roots of the lumbosacral plexus (T12-S5) and cervicothoracic plexus (C5-T1-2). Twenty points will be irradiated for 30 seconds (total treatment time: 10 minutes).
15937623|NCT03360487|Radiation|Photobiomodulation in the radial artery|Intravascular laser irradiation will be applied to the skin in the region of the radial artery with a specific bracelet of the DMC laser Therapy EC model.
15937624|NCT03360474|Behavioral|Delirium Screen|Patients who screen positive for delirium will be assessed for pain, electrolyte imbalances,infection, the use of deliriogenic medications and any issues will be resolved. Those with persistent delirium following all other intervention will be treated with antipsychotic medication.
15937625|NCT03360461|Drug|EMI-137|EMI-137 - a fluorescent c-Met receptor targeted peptide
15937626|NCT03360448|Drug|Ad5.hAC6|1:1 randomization (Ad5.hAC6 : placebo) - intracoronary delivery
15937627|NCT03360448|Drug|Placebo|1:1 randomization (Ad5.hAC6 : placebo) - intracoronary delivery
15937628|NCT03360435|Dietary Supplement|Patch MD MultiVitamin Plus patch|The transdermal patch contains vitamins A, D, E, K2, C, thiamine, riboflavin, niacin, pantothenic acid, pyridoxine, biotin, folic acid, cyanocobalamin, calcium, iron, phosphorous, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, potassium, chloride, and boron.
15937629|NCT03360422|Other|Survey|Respondents meeting inclusion criteria will be informed they were selected for the longer survey and continue to the survey. Upon completion, the survey will generate a study identification (ID) that respondents will provide to study staff with additional contact information via phone, text or email to be compensated
15937630|NCT03360422|Other|Focus Group|After informed consent, participants will complete the web-based intervention component in development. Afterward, participants will be engaged by an experienced facilitator in a discussion of aspects of the intervention they liked and disliked and suggestions they have for enhancing its cultural appropriateness to young MSM.
15937631|NCT03360422|Other|Usability study|After informed consent, participants will utilize the mobile intervention in development for 30 days to establish usability, acceptability and correct any functionality issues.
15937632|NCT03360409|Procedure|ACD|Undertake anterior cervical discectomy without fusion
15937633|NCT03360409|Procedure|ACDF|anterior cervical discectomy with fusion
15937634|NCT03360409|Procedure|ACDA|anterior cervical discectomy with arthroplasty
15937635|NCT03360396|Device|Endobronchial Coils|Endobronchial Coil implants
15937636|NCT03360383|Procedure|percutaneous vertebroplasty|Undertake Percutaneous vertebroplasty with polymethylmetacrylate bone cement.
15937637|NCT03360383|Procedure|conservative treatment|complete on bed with prevention of complications
15937638|NCT03360370|Other|Ages & Stages Questionnaires, Third Edition in French (ASQ-3™)|"This questionnaire screens 5 neurodevelopmental areas (communication, gross motor, fine motor, problem solving and personal-social); 30 items per questionnaire about the child's abilities are evaluated.
~It takes about 15-20 minutes. Data are collecting and a scoring by a professional is provided. Follow-up action is taken for children at risk. Medical and surgical history is also collected to detect risk factors for neurodevelopmental disorders among neonatal data, characteristics of congenital heart disease and first surgery, and other comorbidities."
15937639|NCT03360357|Procedure|Guided drills|"These residents will perform 5 set of exercises:
~Needle Dance (Learning to manipulate the suture)
~Loopy Loop (Learning to place needle through a loop)
~Slalom Course (Passing the needle and suture through 5 rings right handed and left handed)
~Dense Matter (Passing the needle through dense material without losing control of the needle)
~Respect for tissue (Passing the needle through flimsy material without tearing)"
15937640|NCT03360344|Device|Kinesio 12 inch Tape|Kinesio Tape approximately 12-inch strip will be applied to the dorsal surface of the forearm of the affected side for three-day increments over three weeks of the study.
15937641|NCT03360344|Device|Kinesio 4 inch Tape|Kinesio Tape for the control group will be a 4 inch Kinesio Tape applied to the scapular spine for three day increments over three weeks of the study.
15937642|NCT03360344|Device|Cock up Splint and Lumbrical exercises|A general cock-up splint will be supplied, fitted, and checked on each of the four return visits by the researchers. Lumbrical exercises are also used and consist of active joint ranges for the wrist and hand. The exercises will be demonstrated by the researchers for 3-sets of 10 times each, daily, to be recorded in a log by the participants.
15937643|NCT03360318|Device|elbow cast|elbow cast
15937644|NCT03360318|Device|Removable elbow brace|Removable elbow brace
15937645|NCT03360305|Behavioral|GAPcare intervention|Subjects will receive PT and pharmacist evaluation. PT will help determine whether subject may benefit from doing exercises to improve strength or balance. PT may also supply subject with an assist device. A pharmacist will ask patient about any medication they are taking and will make recommendations on how their medication could be changed to prevent falls. Pharmacists will communicate this information to subject's doctors. Subjects will receive a fall calendar for home, where they will record any falls they have after their discharge from the ED. They will receive a phone call at home asking about any recent falls and health care interactions. Study personnel will call subjects every 2 weeks for 6 months. Subjects may receive a referral for outpatient or home-based physical and occupational therapy at the end of the visit.
15937646|NCT03360292|Other|Higher target range|Intervention is using a higher oxygen saturation target range than in routine practice
15937647|NCT03360279|Device|Regular balloon|Randomization: to use regular balloon to treat stent graft restenosis
15937648|NCT03360279|Device|DCB (paclitaxel-coated balloon)|Randomization: to use DCB (paclitaxel-coated balloon, Ranger, Boston-Scientific) to treat stent graft restenosis. The paclitaxel dose is 2 ug/mm2 delivered with the Ranger drug-coated balloon.
15937649|NCT03360266|Combination Product|Sodium Fluoride with CPP-ACP varnish|for children with ECC, this varnish effectively remineralizes the white spot lesion
15937650|NCT03360266|Combination Product|sodium fluoride with ACP varnish|for children with ECC, this varnish effectively remineralizes the white spot lesion
15937651|NCT03360266|Drug|5% Sodium Fluoride Varnish|ffor children with ECC, this varnish effectively remineralizes the white spot lesion
15937652|NCT03360253|Dietary Supplement|L. reuteri DSM 17938 in drops|L. reuteri DSM 17938 will be given at a dose of 5 drops containing 1x108 colony-forming units (CFU) once time per day in an oil formulation delivered from a drop bottle
15937653|NCT03360253|Other|Placebo|The placebo consists of an identical formulation except that the L. reuteri is not present
15937654|NCT03360227|Device|implantation of cardiac devices|implantation of cardiac devices
15937655|NCT03360214|Drug|Bupivacaine Hydrochloride|For active drug, 0.25% marcaine, will be used.
15937656|NCT03360214|Other|Placebo Drug|For sham drug, 0.9% saline, will be used.
15937657|NCT03360214|Device|Pulsed Electromagnetic Field (PEMF) Device|The pulsed electromagnetic field signal will consist of a 2-m sec burst of 27.12 megahertz (MHz) radiofrequency sinusoidal waves repeating at 2 bursts/second.
15937658|NCT03360214|Other|Placebo Device|Sham devices will appear identical to and will be used in exactly the same manner as active devices but will produce no electromagnetic field.
15937659|NCT03360214|Drug|Ropivacaine Hydrochloride|For active drug, 0.25% naropin, will be used.
15937660|NCT03360201|Behavioral|"Tuko Pamoja, We are Together in Kiswahili"|"Tuko Pamoja, We are Together in Kiswahili; This intervention, delivered by lay counselors and through existing community social structures, focuses on improving family relationships and mental health with content derived from evidence-based practices; these include solution-focused family therapy and cognitive behavioral strategies. It is components based, with modules delivered based on need. Tuko Pamoja includes a smart phone component to support psychoeducation components and data collection. The content and structure has been adapted in both content and implementation model based on formative research in this context."
15937661|NCT03360175|Other|No intervention - observational study|No intervention - observational study
15937662|NCT03360136|Behavioral|Multi-professional CBT-rehabilitation|"See Detailed description"
15937663|NCT03360123|Drug|Midazolam Hydrochloride 2Mg/mL Syrup|Midazolam HCl Syrup 0.5mg/kg (Max: 15mg) taken 10-15 minutes prior to dental treatment.
15937664|NCT03360123|Drug|Triazolam 0.125 MG|Triazolam: 0.125mg tablet taken 30 minutes prior to dental treatment.
15937665|NCT03360110|Device|Phoebe test lens|Daily disposable contact lens
15937666|NCT03360110|Device|stenfilcon A lens (control)|Daily disposable contact lens
15937667|NCT03360097|Procedure|Frozen Embryo Transfer|Patient's embryos are cultured to day 6, vitrified and transferred in a cryo-synthetic cycle
15937668|NCT03360084|Procedure|Percutaneous lung biopsy under CT guidance|Percutaneous lung biopsy under CT guidance
15937669|NCT03360071|Drug|Allergen Immunotherapy Extract|Allergen Immunotherapy treatment mixture to be delivered subcutaneously
15937670|NCT03360071|Drug|Allergen Immunotherapy Control|Allergen Immunotherapy Control Solution to be delivered subcutaneously
15937671|NCT03360058|Behavioral|Small Talk Big Difference Immediate access training|Immediate access to 1 hour online training and supporting print materials for implementation in primary care practice
15937672|NCT03360058|Behavioral|Small Talk Big Difference delayed access training|Delayed access (by 4 months) to 1 hour online training and supporting print materials for implementation in primary care practice
15937673|NCT03360045|Drug|Tranexamic Acid|500mg tranexamic acid is sprayed in the nose by atomizer spray, and then is applied nasal compression by manually.
15937674|NCT03360045|Drug|Normal saline|5 cc normal saline is sprayed in the nose by atomizer spray, and then is applied nasal compression by manually.
15937675|NCT03360045|Device|Merocel|Merocel packing is applied.
15937676|NCT03360019|Device|Activlink insole|Dementia patients will wear the provided insole inserted into their own shoes. The insole will have a small electronic sensor that measures acceleration, foot force, and/or orientation.
15937677|NCT03360019|Other|Activlink Phone Application|Smartphone tool used for monitoring location
15937678|NCT03360006|Drug|ABBV-744|Tablet, oral
15937679|NCT03359993|Procedure|Premedication of intubation|The umbilical vein is punctured to inject drugs efficiently. The access is simple, the umbilical vein is clearly visible, and a blood reflux can be found easily. We used the same equipment required for a peripheral venous injection: 24 gauge cannula, antisepsis, compress, and a syringe with the prepared anesthetic drugs. We report 5 cases of intubations in the delivery room using this method to administer the premedication.
15937680|NCT03359980|Drug|fecal microbiota transfer|transfer of fecal microbiota from healthy donors to the patients
15937681|NCT03359967|Drug|Entresto tablet|Changes in intrathoracic impedance and other related parameters between before- and after Sacubitril/Valsartan treatment collected via previously implanted device algoritm. (OptiVol Fluid Index)
15937682|NCT03359954|Radiation|Radiation Therapy|Undergo radiation therapy
15937683|NCT03359954|Procedure|Therapeutic Conventional Surgery|Undergo breast surgery
15937684|NCT03359941|Procedure|acupuncture|Acupuncture points: Examples of acupuncture points to be used include BL23 (Sinsu, bilateral), BL24(Gihaesu, bilateral), BL25(Daejangsu, bilateral), BL40(Wijung, bilateral), BL60(Gollyun, bilateral), BL65(Sokgol, bilateral), LI11(Gokji, bilateral), LI4(Hapgok, bilateral), ST36(Joksamni, bilateral), GB41(Jogimeup, bilateral), LR3(Taechung, bilateral). Electrical stimulation with alternating frequency of 2-100 Hz will be applied to the selected points (e.g., BL 23-25, bilateral). Treatments will be provided by qualified Korean traditional medicine doctors with more than 2 years of clinical experience.
15937685|NCT03359928|Behavioral|Boxing|as already discussed
15937686|NCT03359928|Behavioral|Stair stepping|as already discussed
15937687|NCT03359928|Behavioral|Stair climbing|as already discussed
15937688|NCT03359915|Behavioral|COPD Self-Management Plan|Patient education in use of a COPD self-management action plan supported by monthly visits from, and access to, a CHW who has been trained in the use of a COPD self-management action plan.
15937689|NCT03359902|Device|Transcutaneous vagal nerve stimulation|Non-invasive stimulation provided by transcutaneous electrical nerve stimulation device at 20Hz, 100 μs pulse width
15937690|NCT03359902|Device|Sham stimulation|Sham stimulation will be performed using electrodes placed on earlobe
15937691|NCT03359889|Drug|PraxbindTM|Drug
15937692|NCT03359876|Drug|Rivaroxaban (Xarelto, BAY59-7939)|15 mg, once daily
15937693|NCT03359876|Drug|Warfarin sodium|Individually adjusted dose
15937694|NCT03359863|Drug|Pirfenidone|Subjects will receive pirfenidone for 52 weeks, titrated to 2403 mg/day (3 capsules, 3× daily) after a 4-week titration period (1 capsule, 3x daily for 2 weeks, 2 capsules, 3x daily for 2 weeks) for a total of 56 weeks of pirfenidone. Eligible participants will continue pirfenidone beyond 56 weeks.
15937787|NCT03359135|Device|Compression Garment|Rehabilitation associated to wearing CG during 4 weeks
15937695|NCT03359850|Drug|Niraparib|Niraparib is a potent, orally active PARP1 and PARP2 inhibitor being developed as a treatment for patients with tumors that harbor defects in the homologous recombination DNA repair pathway or that are driven by PARP-mediated transcription factors.
15937696|NCT03359837|Drug|INSULIN GLARGINE (HOE901)|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous injection"
15937697|NCT03359837|Drug|Insulin Glulisine|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous injection"
15937698|NCT03359837|Drug|Biphasic insulin aspart 30|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous injection"
15937699|NCT03359837|Drug|Repaglinide|"Pharmaceutical form: tablet
~Route of administration: oral administration"
15937700|NCT03359837|Drug|Acarbose|"Pharmaceutical form: tablet
~Route of administration: oral administration"
15937701|NCT03359837|Drug|Metformin|"Pharmaceutical form: tablet or capsule
~Route of administration: oral administration"
15937702|NCT03359824|Other|Exercise|
15937703|NCT03359811|Drug|Local Anesthetic Solution|A bolus or infusion of local anesthetic solution with or without the addition opioids given before surgical incision according to anesthesia provider's clinical judgment.
15937704|NCT03359811|Drug|Bupivacaine HCl|30 mg of Bupivacaine HCl in 10 cc of preservative free normal saline (PFNS) injected before surgical incision in each of the four quadrants.
15937705|NCT03359811|Drug|Liposomal Bupivacaine|65 mg of Liposomal Bupivacaine in 10 cc of PFNS injected before surgical incision in each of the four quadrants.
15937706|NCT03359798|Behavioral|Narcotic counseling script|Script regarding post-cesarean section narcotic use
15937707|NCT03359798|Behavioral|Post-partum depression counseling script|Study participants will be read a script of the same length, and much of the same wording as the experimental script. However, this script's content is focused on post-partum depression.
15937708|NCT03359785|Drug|TAK-831 500 mg|TAK-831 Tablets.
15937709|NCT03359785|Drug|TAK-831 50 mg|TAK-831 Tablets.
15937710|NCT03359785|Drug|Matching Placebo|Matching Placebo Tablets.
15937711|NCT03359772|Other|Kinesthetic Ability Trainer|Kinesthetic Ability Trainer
15937712|NCT03359759|Other|Conected objects|"Every week, each patient report her symptoms and answer ten questions on the i-PAD. The connected watch reports the performance status (activtiy and time spent in bed or sitting), and the falls.
~If nurses or doctors detect any problem, they ask the patient for a telemedicine to try to help her. During the same time, nurses or doctors send a message on a secure plateform to the local team (nurse, General Practitioner, and pharmacists) and they reserve a place for an hospitalization if necessary."
15937713|NCT03359746|Drug|Grazoprevir/Elbasvir|Medication for treatment of patient
15937714|NCT03359733|Drug|TAK-659|TAK-659 tablet.
15937715|NCT03359720|Other|no intervention survey|survey
15937716|NCT03359707|Other|survey|no intervention just survey
15937717|NCT03359694|Drug|DT group|Pegylated liposomal doxorubicin 30mg/m2，iv，d1， Docetaxel 75mg/m2，iv，d1， q21d×6
15937718|NCT03359694|Drug|ET group|Conventional doxorubicin 75mg/m2，iv，d1， Docetaxel 75mg/m2，iv，d1， q21d×6
15937719|NCT03359694|Drug|NX group|Navelbine IVD 25 mg/m2 D1、D8 Xeloda PO 1000 mg/m2 bid D1-D14 q21d
15937720|NCT03359681|Drug|Metformin Hydrochloride|metformin 500mg three times a day 20 days before colon cancer surgery and 10 days after.
15937721|NCT03359681|Drug|Placebo oral capsule|placebo 500mg three times a day 20 days before colon cancer surgery and 10 days after.
15937722|NCT03359668|Diagnostic Test|Use of IV contrast during head and neck CT|Use of IV contrast during head and neck CT
15937723|NCT03359655|Drug|Misoprostol|Rectal administration 2 jours before the procedure
15937724|NCT03359655|Drug|Hyoscine butyl bromide|Rectal administration 2 jours before the procedure
15937725|NCT03359642|Other|blood sample|14 ml whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation
15937726|NCT03359642|Other|stool samples|Study of the fecal microbiota
15937727|NCT03359642|Other|food questionnaire|food questionnaire on the seven days before the collection
15937728|NCT03359642|Other|colonoscopy|Only for patients with ulcerative colitis (in routine care)
15937729|NCT03359642|Other|VOCs profile|Volatile Organic Compounds (VOCs) profile obtained by mass spectrometry
15937730|NCT03359629|Device|Spectrophon Glucometry Monitor|Wearable smartwatch with integrated non-invasive glucose detection system
15937731|NCT03359629|Device|YSI 2300 Stat Plus|Reference commercial glucometer
15937732|NCT03359616|Procedure|Transanally curable surgical resection|Transanally, the rectal cancer will be mobilized with oncological principle of total mesorectal excision
15937733|NCT03359616|Procedure|Laparoscopic total mesorectal excision|Conventionally by laparoscopic surgery, the rectal cancer will be mobilized with oncological principle of total mesorectal excision
15937734|NCT03359603|Device|Electro-acupuncture|"Patients will be treated by use of 5 obligatory and 3 customized acupoints. Obligatory points (ST35, EX-LE5, LR8, GB33 and Ashi) will be used in all patients. Other 3 customized acupoints should be chosen by the physicians on the basis of traditional Chinese medicine diagnosis for acupuncture channels related to the individual pain area, with the intent of optimizing efficacy. ST34, ST36, ST32, ST40 and EX-LE2 will be used for pain at stomach meridian. GB31, GB36, GB34, GB39 and GB41 will be used for pain at gallbladder meridian. BL39, BL40, BL57 and BL60 will be used for pain at bladder meridian. LR7, SP9, SP10, KI10, SP4, SP6, LR3 and KI3 will be used for pain at three yin meridians of foot. Needles will be stimulated manually for 10 seconds to achieveDe Qi. Paired alligator clips will be attached transversely to the needle holders at LR8-GB33 and two other customized acupoints. Other needles will be manipulated for 10 seconds during the treatments."
15937735|NCT03359590|Drug|Sitagliptin 100 mg|The treatment consists of sitagliptin tablets (100 mg/day) for up to 24 weeks.
15937736|NCT03359590|Drug|Placebo|The treatment consists of placebo tablets for up to 24 weeks.
15937737|NCT03359577|Dietary Supplement|Psorax35|This is a randomized, 32 weeks, single center, placebo controlled, double blind study to investigate Psorax35 supplementation in patients with mild to moderate Psoriasis. Groups of patients will be block randomized using randomly selected block sizes, and stratified according to gender.
15937783|NCT03359161|Combination Product|sc2Wear Furosemide Infusor|Subcutaneous furosemide for the treatment of fluid overload
15937784|NCT03359148|Device|Disposable ventilator system|
15937738|NCT03359577|Dietary Supplement|MCT oil|This is a randomized, 32 weeks, single center, placebo controlled, double blind study to investigate Psorax35 supplementation in patients with mild to moderate Psoriasis. Groups of patients will be block randomized using randomly selected block sizes, and stratified according to gender.
15937739|NCT03359564|Procedure|micro endoscopic discectomy|the patients receive micro endoscopic discectomy surgery therapy
15937740|NCT03359538|Drug|Rapamycin|tablets containing Rapamycin/placebo will be administered based on body surface area and adjusted taking into consideration plasma rapamycin dosage
15937741|NCT03359538|Drug|Placebo Oral Tablet|tablets containing Rapamycin/placebo will be administered based on body surface area and adjusted taking into consideration plasma rapamycin dosage
15937742|NCT03359525|Drug|Tranexamic Acid|intravenous versus Intraarticular versus intravenous
15937743|NCT03359512|Device|qCON monitor|supervision by qCON monitor of the depth of anesthesia
15937744|NCT03359499|Drug|Bacillus clausii|Oral suspension administered BID
15937745|NCT03359499|Drug|Trimebutine|One tablet of 200 mg of trimebutine administered BID
15937746|NCT03359486|Behavioral|Group problem management plus|Low intensity group psychological intervention including stress management, behavioral activation, problem solving, and strengthening social support
15937747|NCT03359486|Behavioral|Enhanced treatment as usual|Referral to primary care workers trained in mental health Gap Action Program Implementation Guide
15937748|NCT03359473|Drug|GSK2881078|GSK2881078 will be available as capsules for oral administration. GSK2881078 will be administered once daily by the oral route at a dose of 1 mg and 2mg to post-menopausal female subjects and male subjects, respectively.
15937749|NCT03359473|Drug|Matching Placebo|Subjects will be administered two capsules of GSK2881078 matching placebo once daily by the oral route.
15937752|NCT03359447|Drug|Weekly Ferrous Sulfate|Drops
15937753|NCT03359447|Drug|Daily Ferrous Sulfate|Drops
15937754|NCT03359434|Device|Clearsight device (Edwards) around the finger|Continuous measurement of blood pressure with the Clearsight device (Edwards) around the finger, within 24 hours after reperfusion:
15937755|NCT03359434|Device|Intermittent blood pressure measurements with cuff.|Standard method: 35 blood pressure measurements with cuff within 24 hours after reperfusion
15937756|NCT03359408|Behavioral|Dementia Care Management (DCM)|"A specialised discharge management, based on Dementia Care Management (DCM; Thyrian et al. 2017, Eichler, Thyrian, Fredrich et al. 2014, Eichler, Thyrian, Dreier et al. 2014, Dreier et al. 2016, ) will be applied to subjects with cognitive impairment. Specifically qualified will conduct comprehensive data assessments during the hospital stay, assess recommendations at discharge and assess unmet needs at home. Supported by a a computerized Intervention Management (IMS) and in close cooperation with the discharging hospital, treating physicians and other care providers, they will develop, implement and monitor a treatment and care plan. Interventional home visits will take place at the participants homes."
15937757|NCT03359395|Drug|Alfentanil|Administration of alfentanil during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
15937758|NCT03359395|Drug|Placebos|Administration of a equidose placebo during the induction and maintenance of anesthesia for electroconvulsive therapy to be performed
15937759|NCT03359382|Other|Resistance or home exercise combined with eccentric exercise|"First year: Progressive resistance exercise (60-80% RM) combined with low intensity eccentric exercise (10%RM).
~Second year: Progressive resistance exercise (60-80% RM) combined with progressive eccentric exercise (10-80% RM).
~Third year:Home exercise combined with low intensity eccentric exercise (10% RM )"
15937760|NCT03359369|Diagnostic Test|level of serum cholesterol and triglyceride|other
15937761|NCT03359356|Drug|Dupilumab|A total of 24 doses
15937762|NCT03359356|Drug|Placebos|A total of 24 doses
15937763|NCT03359330|Other|Degradable Conduit Small Gap Tublization|Degradable Conduit Small Gap Tublization Repairing Peripheral Nerve Injury
15937764|NCT03359317|Behavioral|jogging|Jogging as instructed for 1 year
15937765|NCT03359291|Drug|Rosuvastatin|Single oral dose of 10 mg rosuvastatin (film-coated tablet) on Day 1 and Day 10
15937766|NCT03359291|Drug|Macitentan|Single oral dose of 30 mg macitentan (film-coated tablet) on Day 5 and 10 mg macitentan administered orally from Day 6 to Day 16
15937767|NCT03359278|Procedure|open reduction and internal fixation|The volar approach was used for open reduction and internal fixation of distal radius fractures
15937768|NCT03359265|Device|underpants|
15937769|NCT03359252|Procedure|non-stent assisted coiling|non-stent assisted coiling of unruptured intracranial aneurysm
15937770|NCT03359252|Procedure|stent assisted coiling|stent assisted coiling of unruptured intracranial aneurysm
15937771|NCT03359239|Drug|Atezolizumab|1200 mg administered by IV infusion every 3 weeks (21 [+/-2] days) for up to 12 months in the adjuvant setting and up to 24 months in the metastatic setting.
15937772|NCT03359239|Biological|PGV001|"PGV001: up to ten total doses of PGV001with helper peptides. The product is prepared within the ISMMS . The product consists of two independent preparations of patient specific long peptides mixed with poly-ICLC.
~A dose of PGV001 consists of the following:
~Up to ten synthetic peptides - 100μg (0.01 mL, 10 mg/mL) per peptide. One tetanus helper peptide - 100μg (0.01 mL, 10 mg/mL)"
15937773|NCT03359239|Drug|Poly ICLC|1.4 mg (0.7 mL, 2 mg/mL)
15937774|NCT03359239|Drug|Normal saline|0.19 mL
15937775|NCT03359226|Procedure|Submandibular gland biopsy|Needle biopsies of the right and left submandibular glands
15937776|NCT03359213|Drug|JR-141|IV infusion (lyophilized powder), 1.0 mg/kg/week
15937777|NCT03359213|Drug|JR-141|IV infusion (lyophilized powder), 2.0 mg/kg/week
15937778|NCT03359213|Drug|JR-141|IV infusion (lyophilized powder), 4.0 mg/kg/week
15937779|NCT03359187|Other|Normal saline with salt/Soda|Head and Neck cancer Patients have to rinse 4 times a day/everyday for 15 ml. each time during and after completed the radiation treatment
15937780|NCT03359187|Other|Clinacanthus nutans|Head and Neck cancer Patients have to rinse 4 times a day/everyday for 15 ml. each time during and after completed the radiation treatment
15937781|NCT03359187|Other|Boesenbergia rotunda|Head and Neck cancer Patients have to rinse 4 times a day/everyday for 15 ml. each time during and after completed the radiation treatment
15937788|NCT03359096|Device|Therapeutic HGNS|Prior to enrollment in this study, the HGNS will have been implanted as part of clinical care, and a therapeutic voltage setting will have been determined via overnight sleep study The pulse generator, using technology from cardiac pacemakers, utilizes the signal from the pressure sensor for timing of stimulation to the tongue nerve. Patient will undergo activation of the implanted device one month post-operatively. A functional threshold (in volts) is obtained based on tongue motion during device stimulation. For the next month, the patient will have steadily increased stimulation strength by 0.1V every 2-3 nights within the preset range until the upper limit is reached.
15937789|NCT03359096|Device|Subtherapeutic 'Sham' HGNS|"Sham threshold determination will be performed as follows. The patient will be in a reclined position with the mouth open while nasal breathing. Stimulation will be increased from 0.1V up by 0.1V until bulk tongue motion is detected without obvious protrusion. This process is repeated twice and the average value is used to determine sham-HGNS. The electrode configuration will remain consistent between the patient's therapeutic and sham thresholds"
15937790|NCT03359083|Other|Correlation|Correlation between assesment parameters
15937791|NCT03359070|Drug|Dapaconazole|Application of 1 gram on the lesion.
15937792|NCT03359070|Drug|Miconazole Nitrate|Application of 1 gram on the lesion.
15937793|NCT03359057|Drug|ethinyl estradiol + levonorgestrel + folic acid|One coated tablet of ethinyl estradiol + levonorgestrel + folic acid, 0.02 mg + 0.10 mg + 0.4 mg for 21 days in 3 cycles (12 weeks).
15937794|NCT03359057|Drug|Folic Acid|One coated tablet of folic acid 0.4 mg for 7 days in 3 cycles (12 weeks).
15937795|NCT03359031|Other|Patient education|This group will be given a pamphlet on pain control, narcotic medication, and compartment syndrome including its pathophysiology, signs/symptoms, and treatment.
15937796|NCT03359018|Drug|Apatinib|Every patients will received apatinib 250mg or 500mg orally daily according to their body surface area (BSA) until disease progression or intolerance to side effects.
15937797|NCT03359018|Drug|SHR-1210|Every patients will received SHR-1210 3mg/kg (no more than 200mg) iv every 2 weeks until disease progression or intolerance to side effects.
15937798|NCT03359005|Drug|Vincristine|vincristine 1.5mg/m2 iv D1,D8
15937799|NCT03359005|Drug|Temozolomide|Temozolomide 100mg/m2/d iv on days 1-5.
15937800|NCT03358966|Other|Doubly-labelled water technique|
15937801|NCT03358966|Other|Resting Energy Expenditure|Resting energy expenditure represents the amount of calories required for a 24-hour period by the body during a non-active period.
15937802|NCT03358953|Device|Electron Cigarette|Blended Tobacco flavour, 18mg/ml
15937803|NCT03358953|Device|Nicotine Replacement Patch|NiQuitin 21mg
15937804|NCT03358940|Other|urine collection|For patient with miscarriage complications or not, or threatened miscarriage there will be a urine collection the day of the inclusion. In case of hospitalization, another urine collection will be done between 12 and 18 hours after the inclusion. For patient coming for voluntary termination of pregnancy using misoprostol, a urine collection will be done the day of the inclusion and another ones 1, 4, 12 and 24 hours after the inclusion.
15937805|NCT03358927|Behavioral|Immediate Fast-Track Care|Eligible for fast-track care at enrollment
15937806|NCT03358927|Behavioral|Deferred Fast-Track Care|Eligible for fast-track care after 6 months on ART
15937807|NCT03358914|Other|No intervention|Completion of surveys
15937808|NCT03358901|Drug|YC-6|
15937809|NCT03358901|Drug|Vehicle|
15937810|NCT03358888|Drug|Multi-modal with as needed opioids|Multi-modal with as needed oxycodone and tramadol provided for break-through pain
15937811|NCT03358888|Drug|Multi-modal with one week of opioids offered|Multi-modal with only one week of oxycodone and tramadol provided for emergency pain relief only
15937812|NCT03358888|Drug|Standard of Care|This arm follows standard of care post-operative pain management with oxycodone, tramadol, and acetametophin
15937813|NCT03358875|Drug|Tislelizumab|Intravenous injection (Anti-PD-1 monoclonal antibody)
15937814|NCT03358875|Drug|Docetaxel|Intravenous injection (Antineoplastic, cytotoxic, taxane)
15937815|NCT03358862|Device|NaturalVue Multifocal Contact Lens|NaturalVue multifocal contact lenses are daily disposable, distance center, multifocals with a novel extended depth of focus optical design. Patients wearing their habitual corrections who opt to change to this new lens will have their myopia progression monitored for up to two years.
15937816|NCT03358849|Biological|Natural killer cell|Patients who received natural killer cell injection
15937817|NCT03358810|Device|PES|The PES system is a two-part neurostimulation system. It is composed of a durable component called the Base Station and the single-use sterile disposable Phagenyx® Catheter. The Base Station acts as the user interface and provides the means to generate, optimize and monitor the delivery of electrical stimulation.
15937818|NCT03358797|Behavioral|Attention-control|Lifestyle intervention with presentations by multiple professionals (nutritionists, exercise trainers, and psychotherapists), this intervention will include Mediterranean diet education, physical activity, social support, food tasting and cooking, goal setting,and women's health topics
15937819|NCT03358797|Behavioral|Community based intervention with resilience training|Lifestyle intervention with presentations by multiple professionals (nutritionists, exercise trainers, and psychotherapists), this intervention will include Mediterranean diet education, physical activity, social support, food tasting and cooking, goal setting, and women's health topics. In addition, there will be content targeting resilience training including: positive emotions, cognitive flexibility, life meaning, and active coping strategies.
15937820|NCT03358797|Behavioral|intervention-HPP|Lifestyle intervention with presentations by multiple professionals (nutritionists, exercise trainers, and psychotherapists), this intervention will include Mediterranean diet education, physical activity, social support, food tasting and cooking, goal setting,and women's health topics. In addition, there will be training in leadership skills, community interventions, community needs assessment, intervention planning and outcomes assessment.
15937821|NCT03358797|Behavioral|Pilot|Lifestyle intervention with presentations by multiple professionals (nutritionists, exercise trainers, and psychotherapists), this intervention will include Mediterranean diet education, physical activity, social support, food tasting and cooking, goal setting, and women's health topics. In addition, there will be content targeting resilience training including: positive emotions, cognitive flexibility, life meaning, and active coping strategies.
15937894|NCT03358407|Drug|Placebo|Placebo oral capsules matching GSK2983559 will be available for subjects.
15937822|NCT03358784|Procedure|Hemi-shoulder Arthroplasty|Hemi-shoulder Arthroplasty treating three or four-part fractures of proximal humerus
15937823|NCT03358784|Procedure|PHILOS Plate|PHILOS plate treating three or four-part fractures of proximal humerus
15937824|NCT03358771|Other|COPD discharge care bundle|As a part of RHSCN quality improvement initiative, the elements of the COPD discharge bundle were integrated into a standardized COPD admission order set and are being implemented province-wide. The discharging physician/team will complete the COPD bundle (with reminders facilitated by clinical decision support tools) prior to patient discharge. A copy of the bundle is retained in the patient's medical record, and another copy is sent to the patient's primary care provider detailing the components of the bundle that were completed prior to discharge, and those still needing to be addressed. The patient will also receive a patient-focused discharge checklist detailing discharge bundle items
15937825|NCT03358771|Other|COPD discharge care bundle & coordinator|The coordinator will be health professional associated with a Primary Care Network, ED or AHS with access to patient information. Patients will be informed that care coordinator may contact them for follow up after discharge. At 48-72 hours after hospital/ED discharge and then at intervals to be determined, the care coordinator will contact the patient by phone. The care coordinator will identify specific needs or problems that patient may have encountered after discharge, which could potentially affect the successful transition from acute to community care setting. Specifically, the care coordinator will seek information on any follow up with family doctor visit, pulmonary rehabilitation and smoking cessation referrals
15937826|NCT03358745|Other|Standard meal, bread/butter as starter|Reference lunch. Bread and butter are eaten during the first 15 min. Soup, cheese and salad are eaten within the following 15 min.
15937827|NCT03358745|Other|Standard meal with soup as starter|Lunch meal in which soup is eaten during the first 15 min. Bread, butter, cheese and salad are eaten within the following 15 min.
15937828|NCT03358745|Other|Standard meal with cheese as starter|Lunch meal in which cheese is eaten during the first 15 min. Bread, butter, soup and salad are eaten within the following 15 min.
15937829|NCT03358745|Other|Standard meal with salad as starter|Lunch meal in which salad is eaten during the first 15 min. Bread, butter, soup and cheese are eaten within the following 15 min.
15937830|NCT03358732|Device|endometrial navigation one day before the embyo transfer using IUI catheter ,|one day before the actual ET, the participants, in the study group, were taken into the operating room with a moderately full bladder at 10 am. The patient was placed in the lithotomy position and a sterile speculum was inserted into the vagina. The cervix was cleaned with sterile swabs and sterile water, and a mock transfer was performed using a soft catheter (Wallace Intrauterine Insemination Catheter; Sims Portex Ltd., Hythe, Kent, UK). The catheter has an outer sheet with memory , to aid insertion, and a soft inner catheter with atraumatic tip. Under ultrasound guidance, only the soft inner catheter was introduced beyond the internal cervical os till it was 0.5 cm from the fundus. It was, then, gently withdrawn out of the uterus, and the speculum was removed.
15937831|NCT03358719|Biological|DEC-205/NY-ESO-1 Fusion Protein CDX-1401|Given intracutaneously
15937832|NCT03358719|Drug|Decitabine|Given IV
15937833|NCT03358719|Other|Laboratory Biomarker Analysis|Correlative studies
15937834|NCT03358719|Biological|Nivolumab|Given IV
15937835|NCT03358719|Drug|Poly ICLC|Given SC
15937844|NCT03358693|Drug|Ustekinumab|Subject receives Ustekinumab open-label as per guidelines
15937845|NCT03358693|Drug|Infliximab|Subject receives Infliximab open-label as per guidelines
15937846|NCT03358693|Drug|Secukinumab|Subject receives Secukinumab open-label as per guidelines
15937847|NCT03358693|Drug|Dupilumab|Subject receives Dupilumab open-label as per guidelines
15937848|NCT03358693|Drug|Brodalumab|Subject receives Brodalumab open-label as per guidelines
15937849|NCT03358693|Drug|Ixekizumab|Subject receives Ixekizumab open-label as per guidelines
15937850|NCT03358693|Drug|Baricitinib|Subject receives Baricitinib open-label as per guidelines
15937851|NCT03358693|Drug|Abrocitinib|Subject receives Abrocitinib open-label as per guidelines
15937852|NCT03358693|Drug|Upadacitinib|Subject receives Upadacitinib open-label as per guidelines
15937853|NCT03358693|Drug|Tralokinumab|Subject receives Tralokinumab open-label as per guidelines
15937854|NCT03358680|Device|noninvasive analgesia measurement|noninvasive analgesia measurement using index of consciousness(IOC2)
15937855|NCT03358667|Procedure|augmentation peri-implant soft tissue|the implant was cover with a 2 mm cover screw for a tent effect or with a dermal membrane after implant insertion
15937856|NCT03358654|Drug|mesenchymal stem cells from umbilical cord|inject mesenchymal stem cells from umbilical cord，and the patients will be followed up at 1, 2, 3, and 6 months after the injection.
15937857|NCT03358641|Other|level of physical activity|According to the result of IPA-Q questionnaire, participants are divided in three groups: low level, moderate level, high level of physical activity.
15937970|NCT03357731|Other|Placebo|Infusion
15937971|NCT03357718|Drug|Precedex|2 µg/kg oral
15937972|NCT03357718|Drug|Midazolam|0.5 mg/kg
15937858|NCT03358628|Other|Molecular Profiling & In Vivo drug testing in PDX|Molecular profiling of host tumour sample and PDX will be performed and analyzed by an expert panel. In vitro drug testing using organoid culture generation may also be performed if sufficient fresh tissue is available. Matched treatment recommendation based on profiling and in vivo PDX drug testing results will be made, if available.
15937859|NCT03358615|Procedure|cesarean section|assessment of the indications of cesarean section according to Robson criteria
15937860|NCT03358602|Radiation|Radiotherapy|Radiotherapy with a dose of 66-70 Gy is used to manage the cervical lymph nodes
15937861|NCT03358602|Procedure|Selective neck dissection|Selective neck dissection, defined as surgical clearance of the upper jugular (leveI II), midjugular (level III) and sometimes submandibular (level I) nodes, is used to manage the cervical lymph nodes
15937862|NCT03358589|Diagnostic Test|FDG-PET/CT|Scans
15937863|NCT03358576|Drug|Ertapenem|Antibiotic for complicated intra-abdominal infection
15937864|NCT03358576|Drug|Sulopenem-Etzadroxil/Probenecid|Antibiotic for complicated intra-abdominal infection
15937865|NCT03358576|Drug|Ciprofloxacin|Antibiotic for complicated intra-abdominal infection
15937866|NCT03358576|Drug|Metronidazole|Antibiotic for complicated intra-abdominal infection
15937867|NCT03358576|Drug|Amoxicillin-Clavulanate|Antibiotic for complicated intra-abdominal infection
15937868|NCT03358576|Drug|Sulopenem|Antibiotic for complicated intra-abdominal infection
15937869|NCT03358563|Drug|Docetaxel|Docetaxel is a commercially marketed product that has been approved by the FDA for the treatment of metastatic prostate cancer. It is also approved for the treatment of other malignant disease, such as locally advanced or metastatic breast cancer that returns after any prior chemotherapy; locally advanced or metastatic non-small cell lung cancer that recurs after prior platinum-based chemotherapy. However, the FDA does not currently approve its use in patients with localized prostate cancer but no evidence of radiographic metastases.
15937870|NCT03358563|Drug|Degarelix|Degarelix is a leuteinizing hormone-releasing hormone (LHRH) antagonist. Degarelix is administered at an initial dose of 240 mg subcutaneously (2 separate injections of 120mg each totaling 240 mg) two weeks prior to cycle 1 day 's 1 treatment with chemotherapy. The initial dose is followed by a maintenance dose of 80mg administered subcutaneously as a single injection every 28 days at cycle 2 day 1 (+/- 7 days) and cycle 3 day 10 (+/- 7 days)
15937871|NCT03358563|Drug|Bicalutamide|The dose for bicalutamide tablets therapy in combination with an LHRH analog (in this study, degarelix) is one 50 mg tablet once daily (morning or evening), with or without food. It is recommended that bicalutamide tablets be taken at the same time each day. Treatment with bicalutamide tablets should be started at the same time as treatment with an LHRH analog.
15937872|NCT03358563|Radiation|Ferumoxytol-enhanced MRI imaging|Ferumoxytol-enhanced MRI imaging will evaluate immune micro-environment in the prostate. Three subjects enrolled to the study will undergo the first ferumoxytol-enhanced MRI imaging within 21 days prior to start of hormonal therapy followed by second and final ferumoxytol-enhanced MRI at the conclusion of hormone therapy but prior to their prostatectomy.
15937873|NCT03358550|Diagnostic Test|Accommodation Measurement|Accommodation was measured for different distances and light conditions.
15937874|NCT03358537|Dietary Supplement|Clear Liquid Diet|Clear liquid diet was compared with low-residue diet, in combination with Poliethylene Glycol in each group
15937875|NCT03358537|Dietary Supplement|Low-residue Diet|Clear liquid diet was compared with low-residue diet, in combination with Poliethylene Glycol in each group
15937876|NCT03358524|Drug|Vitamin E 400 UNT|Vitamin-E capsule (alpha tocopherol) 400 IU (once per day)
15937877|NCT03358524|Drug|Placebo oral capsule|sugar capsule manufactured to mimic vitamin E capsule once per day
15937878|NCT03358511|Dietary Supplement|Probiotic|Primal Defense Ultra® Probiotic Formula is an over-the-counter probiotic that provides 15 billion colony forming units of 13 species of beneficial bacteria, including Saccharomyces boulardii, Lactobacillus plantarum, Bacillus subtilis, Bifidobacterium lactis, Bifidobacterium bifidum, Lactobacillus rhamnosus, Bifidobacterium breve, lactobacillus casei, Lactobacillus salivarius, Lactobacillus acidophilus, Lactobacillus brevis, Bifidobacterium longum, and Lactobacillus paracasei.
15937879|NCT03358498|Other|The Medical Outcomes Short-Form 36-Item Health Survey (SF-36v2) It|"SF-36v2 is questionnaire comprising 36items measuring eight dimensions of general HRQOL: physical functioning 10 items, physical health problems 4 items, bodily pain 2 items, general health perceptions 5 items, vitality 4 items, social functioning (2 items), role limitations due to emotional problems (3 items), and general mental health 5 items.
~."
15937880|NCT03358485|Drug|Aolanti Weikang tablets|Aolanti Weikang tablets is a Chinese patent drug designed to treat Functional dyspepsia (FD).
15937881|NCT03358485|Other|Placebo|Placebo
15937882|NCT03358472|Drug|Pembrolizumab|Pembrolizumab administered intravenously every 3 weeks.
15937883|NCT03358472|Drug|Epacadostat|Epacadostat administered orally twice daily.
15937884|NCT03358472|Drug|Cetuximab|Cetuximab administered intravenously on Cycle 1 Day 1 followed by administration every week.
15937885|NCT03358472|Drug|Cisplatin|Cisplatin administered intravenously every 3 weeks for </= 6 cycles.
15937886|NCT03358472|Drug|Carboplatin|Carboplatin administered intravenously every 3 weeks for </= 6 cycles.
15937887|NCT03358472|Drug|5-Fluorouracil|5-Fluorouracil administered intravenously every 3 weeks for </= 6 cycles.
15937888|NCT03358459|Other|non|non
15937889|NCT03358446|Other|A group|"The optimal range of leg abduction was defined as the range without overlap in A group and the range presenting that the overlap was less-than half of the diameter of femoral vein in S group.
~A1 angle defined the point that the femoral vein and artery started non-overlapping interval when increasing the angle of the leg in the A group and the A2 angle is defined the point that the femoral vein and artery ended non-overlapping interval."
15937890|NCT03358446|Other|S group|B1 is the angle at which the overlap starts at the half of the femoral vein radius when increasing the angle of the leg in the S group, B2 is the angle at which overlap starts at half or more of the femoral vein radius again. In the range of B1 and B2 angles, they are overlapped by half or less of the femoral vein radius.
15937891|NCT03358433|Other|Exercise|
15937892|NCT03358420|Diagnostic Test|Immunohistochemical staining|Pathological liver slides to be immunohistochemically stained for alpha-defensin
15937893|NCT03358407|Drug|GSK2983559|GSK2983559 will be available as oral capsules with dose strength of 2-45 milligram (mg), 100 and 114 mg.
15937895|NCT03358394|Behavioral|A human-interventional study|"The intervention was developed by Ahmed et al. (2017) and was adapted by the investigators for parents of children with T1D. The researcher has received permission form the author to use the script but, not the audio recordings. As a result, we contacted Saab et al. (2016) to get the permission to use the Arabic audio recording of Mindfulness exercises (i.e., introduction to mindfulness practice and mindfulness breathing).
~The mindfulness script to be used in the current study is based on MBPT. In this study, we will be using the MBPT programme, but tailored to the needs of parents of children with T1D. One of the main changes in our study is that it will be delivered via the Internet. Participants in the original MBPT programme attended in-person sessions however, Rayan et al. (2016) delivered only the first two sessions in person and the rest via telephone"
15937896|NCT03358381|Procedure|the gap balance type of total knee arthroplasty|A gap balance type of total knee arthroplasty surgery will be performed.The gap balance group will receive this kind of intervention.
15937897|NCT03358381|Procedure|the measured resection type of total knee arthroplasty|A measured resection type of total knee arthroplasty surgery will be performed.The measured resection group will receive this kind of intervention.
15937898|NCT03358368|Device|Vitalscan|Vitalscan is a magnetocardiograph device
15937899|NCT03358355|Drug|unacelyated ghrelin|We will test doses of 10 ug/kg, 20 ug/kg, and 40 ug/kg of unacylated ghrelin on three separate days for each participant.
15937900|NCT03358342|Other|ePneumonia CDS|ePneumonia clinical decision support system for community-onset pneumonia
15937901|NCT03358329|Combination Product|S8 Sinus Implant|In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
15937902|NCT03358303|Device|Medly|Medly) will enable patients with HF to take clinically relevant physiological measurements with wireless home medical devices and to answer symptom questions on the smartphone. The measurements will be automatically and wirelessly transmitted to the mobile phone and then to a data server. Automated self-care instructions/messages will be sent to the patient based on the readings and reported symptoms. If there are signs of their status deteriorating, an alert will be sent to a clinician that is responsible for the particular chronic condition of concern. The clinicians will have all the relevant patient data sent to them and will be able to access (through a secure web portal) to view historical and trending data for their patients.
15937903|NCT03358290|Drug|JTE-051|Active drug tablets containing JTE-051
15937904|NCT03358290|Drug|Placebo|Placebo tablets identical in appearance to the active drug tablets
15937905|NCT03358277|Drug|MPH + APZ|MPH was administered with either Ritalin (from 10mg/day to 40mg/day) or Concerta (from 18mg/day to 36mg/day) according to clinical judgement for six weeks. APZ was administered with dose from 2.5mg/day to 5mg/day according to clinical judgement for six weeks.
15937906|NCT03358264|Dietary Supplement|L-citrulline|Amino acid supplement
15937907|NCT03358251|Device|Pocket-X Gel|Pocket-X Gel is a biodegradable in-situ gelling product that is inserted into a pre-cleaned periodontal pocket where it quickly turns into a gel that adheres to the periodontal pocket and acts as a filler and physical barrier against bacterial re-colonization at the site of application. Administration of this product typically causes no discomfort. The product naturally degrades after 1-3 weeks.
15937908|NCT03358251|Procedure|Scaling and root planing|Scaling and root planing is a conventional gold-standard treatment for periodontitis. As part of this procedure, subgingival plaque and tartar are removed and root surfaces are planed.
15937909|NCT03358238|Behavioral|Weekly review|Each week in the study, an interviewer will review manic and depressive symptoms self-reported by a participant and patterns of activity, sleep, and heart rate collected by the participant's activity tracker.
15937910|NCT03358238|Other|No weekly review|An interviewer will not review self-report symptoms and patterns collected from an activity tracker.
15937911|NCT03358225|Procedure|anterior cervical discectomy and fusion|The patients undergoing anterior cervical discectomy and fusion sugery
15937912|NCT03358225|Procedure|cervical artificial disc replacement|The patients undergoing cervical artificial disc replacement surgery
15937913|NCT03358225|Procedure|hybrid surgery|The patients undergoing 1-level C-ADR plus 1-level ACDF surgery
15937914|NCT03358212|Drug|Denosumab|Denosumab 120mg was administrated to patients by subcutaneous injection every four weeks, with loading doses on Day 8 and Day 15 of the first cycle.Patients were instructed to take calcium supplements orally every day and avoid any oral operation during treatment
15937915|NCT03358199|Procedure|LOD|Women underwent LOD in the preceding 3 months prior to IVF/ICSI
15937916|NCT03358186|Procedure|surgically treated periprosthetic femur fracture|patients with surgically treated periprosthetic femur fracture
15937917|NCT03358173|Procedure|Conservative Treatment|Conservative Treatment
15937918|NCT03358173|Procedure|Operative Plate Fixation|Operative Plate Fixation
15937919|NCT03358160|Behavioral|Action discrimination tasks.|The investigators will compare the groups' performance during action discrimination tasks related to movements of the upper vs. lower limbs.
15937920|NCT03358147|Drug|GP MDI 28.8 μg|GP MDI (PT001)14.4 μg per actuation taken as 2 inhalations BID
15937921|NCT03358147|Drug|GP MDI 14.4 μg|GP MDI (PT001) 7.2 μg per actuation taken as 2 inhalations BID
15937922|NCT03358147|Drug|GP MDI 7.2 μg|GP MDI (PT001) 3.6 μg per actuation taken as 2 inhalations BID
15937923|NCT03358147|Drug|Placebo MDI|Placebo taken as 2 inhalations BID
15937924|NCT03358147|Drug|Spiriva Respimat 2.5 μg|Spiriva Respimat 2.5 μg QD (open-label)
15937925|NCT03358134|Drug|Secukinumab|anti IL17 therapy (subcutaneous)
15937926|NCT03358121|Diagnostic Test|Clamp study|Clamp study to achieve high, normal, and lower glucose levels to study the dynamics of Asprosin.
15937927|NCT03358095|Device|Tannenbaum Fr 10 stent or WallFlex stent|A plastic or metallic endoprosthesis is placed to the biliary ducts.
15937928|NCT03358082|Drug|Tacrolimus 0.03% Ointment|topical tacrolimus 0.03% twice daily for 6 months
15937929|NCT03358082|Drug|Hydrocortisone Acetate 1% Ointment|hydrocortisone acetate 1% ointment twice daily for 6 months
15937930|NCT03358069|Diagnostic Test|Emergence agitation scale|Emergence agitation scale: PAED scale > 10 defined as positive for Emergence agitation (EA) Post hospitalize behavioral questionnaire (PHBQ) positive Post operative behavioral changes defines as 10 % change from sum score of PHBQ
15937973|NCT03357705|Procedure|alveolar ridge preservation with synthetic bone|after tooth extraction
15972667|NCT03092856|Other|Placebo|Given IV
15937931|NCT03358056|Behavioral|Mindfulness-Based Cognitive Therapy|Mindfulness-based cognitive therapy (MBCT) is a manualized, 8 weeks-group-based training derived from mindfulness-based stress reduction (MBSR) and cognitive-behavioral therapy (CBT). In MBCT participants are trained in how to be more aware of their bodily sensations, thoughts and feelings associated with negative emotional states. Mindfulness exercises and cognitive-behavioral skills are practiced both during the sessions and through homework assignments. The program is structured in 2.30 h group sessions over 8 consecutive weeks.
15937932|NCT03358043|Device|mechanical ventilation|Consecutive intubated pateints receiving mechanical ventilation with a PaO2/FiO2≤300 mmHg on positive end-expiratory pressure (PEEP) of 5 cmH2O or more and FiO2 of 0.3 or more.
15937933|NCT03358030|Drug|ISIS 416858|Subcutaneous injection
15937934|NCT03358030|Drug|Placebo|Subcutaneous injection
15937935|NCT03358017|Drug|Zoledronate|4 mg i.v. every 3/4 weeks for 6 months
15937936|NCT03358017|Drug|Atorvastatin 80mg|80mg /die os for 6 months
15937937|NCT03358017|Drug|Standard neoadjuvant cht|Standard neoadjuvant cht chosen by the investigator and administered according to clinical practice
15937938|NCT03358004|Drug|Vinorelbine Tartrate|Metronomic treatment with vinorelbine 50 mg (three times/week) until progression in ARM A
15937939|NCT03358004|Drug|Capecitabine 500 MG|Metronomic treatment with capecitabine 500 mg (three times/day) combined with vinorelbine 40 mg (three times/week) with until progression
15937940|NCT03357978|Diagnostic Test|bioelectrical impedance analysis|Electrophysical measurement that allows to determine the exact composition of single body compartments by producing a magnetic field and detecting the potential difference through the body
15937941|NCT03357978|Diagnostic Test|blood draw|Blood samples are taken from sober patients
15937942|NCT03357978|Diagnostic Test|transient elastography (FibroScan)|FibroScan is a noninvasive tool to measure liver stiffness as an indication of fatty liver and liver fibrosis using ultrasound
15937943|NCT03357978|Diagnostic Test|ataxia score|Klockgether ataxia score ranges from 0 to 35 points in which 0 means no symptoms and 35 stands for final stage of disease. It includes seven ataxia associated symptoms: dysarthria, intention tremor, ataxia of gait, stance, dysdiadochokinesia, upper limb and lower limb
15937944|NCT03357978|Diagnostic Test|Five-Times-Sit-to-Stand Test|The test measures the complete time which is necessary for an individual to stand up and sit down on a chair five times in series
15937945|NCT03357965|Other|Questionnaire|Women who had gave birth in 6 weeks
15937946|NCT03357952|Drug|Daratumumab|Participants will receive daratumumab 16 milligram per kilogram (mg/kg) intravenously (IV) once every week for 8 weeks (Weeks 1 to 8); then once every other week for 16 weeks (Weeks 9 to 24); then once every 4 weeks (Week 25 onwards).
15937947|NCT03357952|Drug|JNJ-63723283|Participants will receive JNJ-63723283 240 mg IV during Week 1 on Cycle 1 Day 2, Cycle 1 Day 15, then every 2 weeks thereafter.
15937948|NCT03357939|Drug|HLX03|A single dose of 40 mg HLX03 in 0.8 mL in subcutaneous injection.
15937949|NCT03357939|Drug|adalimumab|A single dose of 40 mg Humira in 0.8 mL in a pre-filled syringe
15937950|NCT03357926|Diagnostic Test|24 hour Holter ECG Monitoring|24 hour Holter ECG Monitoring
15937951|NCT03357913|Other|Lung transplantation|To estimate the incidence of non-respiratory co-morbidities after lung transplantation between 2004 and 2014 in the cohort of patients with cystic fibrosis grafted in the Rhône-Alpes region
15937952|NCT03357900|Device|Automated titration of propofol and remifentanil|Calculation of Consumption of propofol and remifentanil
15937953|NCT03357887|Other|Analysis of cerebrospinal fluid and serum|Analysis of biomarkers in patient biological samples
15937954|NCT03357874|Drug|Clopidogrel|600 mg loading dose of clopidogrel as pretreatment followed by 75 mg daily for 12 months (52 weeks).
15937955|NCT03357874|Drug|Ticagrelor|patients will receive a 180 mg loading dose as pretreatment of PCI followed by 90 mg bi-daily for 12 months (52 weeks).
15937956|NCT03357835|Other|Trauma Decision System|At the time of application, color codes indicating the urgency of the patients will be given according to the demographic data of the patients, the type of trauma and the vital signs were directed by the software program. As a result of the software program's direction, patients will be coded as green-yellow-orange-red area and patient care will be made in accordance with these codes.
15937957|NCT03357822|Drug|Pegylated interferon|180ug Pegylated interferon is injected subcutaneously once a week
15937958|NCT03357822|Drug|Entecavir|0.5mg entecavir is orally taken every day
15937959|NCT03357822|Drug|Tenofovir disoproxil fumarate|300mg tenofovir is orally taken every day
15937960|NCT03357809|Procedure|Endoscopic mucosal resection|"Mucosectomy performed at day 1. Endoscopic mucosal resection (EMR) and or endoscopic submucosal dissection (ESD), is at least 3 cm long. The mucosal resection is carried out along the side of the small curvature of the stomach, in order to preserve a valve of the cardia at the level of the large curvature of the stomach.
~A coloured solution is injected into the submucosa following markers. The correct submucosal injection is confirmed by the lifting of the mucosal surface. A submucosal dissection is carried out using the dual knife. The mucosectomy is repeatedly performed until the mucosal zone is completely resected. The choice of the resection technique will depend on the anatomy of the patient."
15937961|NCT03357796|Drug|LY03005|80 mg, oral tablets, single dose
15937962|NCT03357796|Drug|Pristiq|50 mg, oral tablets, single dose
15937963|NCT03357783|Other|Macroscopic deciduosis|Deciduosis is a benign lesion during pregnancy that is not correlated with obstetrical complications. Our study has shown that this physiological phenomenon is more frequent that originally thought, being present in 10% of the Cesarean sections, and is associated with abdominal pain during pregnancy.
15937964|NCT03357770|Drug|mesenchymal stem cells|we will enroll three groups of patients, and they will be therapized by high, medium, and low-dose cytotoxic respectively to evaluate the dose-limiting toxicity (DLT) and establish the maximum tolerated dose (MTD). Dose and cell concentration selection will be based on previous literature [5]. The low-dose is 1 × 10^7cells / 3mL, the medium-dose is 5 × 10^7cells / 3mL and the high dose is 1 × 10^8cells / 3mL
15937965|NCT03357757|Drug|Valproic Acid|The target serum level for VPA will be between 75 and 100 mcg/mL checked every 2 weeks for the first 6 cycles.
15937966|NCT03357757|Biological|Avelumab|10 mg/kg IV
15937967|NCT03357744|Other|distress barometer|not applicable, observational study
15937968|NCT03357731|Drug|HNO Donor|Infusion
15937969|NCT03357731|Drug|Nitroglycerin (NTG)|Infusion
15937974|NCT03357705|Procedure|alveolar ridge preservation with bovine collagen|after tooth extraction
15937975|NCT03357692|Procedure|all on four implant rehabilitation|implant insertion after piezoelectric site preparation for trans-sinusal implants
15937976|NCT03357679|Procedure|Tracheal intubation|Intubation of the trachea with endotracheal tube
15937977|NCT03357679|Device|Glidescope assisted tracheal intubation|With the use of the Glidescope video laryngoscope, the trachea will be intubated with the endotracheal tube
15937978|NCT03357679|Device|Bed up head elevated tracheal intubation|Use of the Macintosh laryngoscope blade size 3
15937979|NCT03357666|Drug|HUDC_VT(Glucose 200mg/Sodium chloride 200mg)|Vaginal administration, two tablets once a day for 7 days
15937980|NCT03357666|Drug|HUDC_VT (Glucose 400mg/Sodium chloride 200mg)|Vaginal administration, two tablets once a day for 7 days
15937981|NCT03357666|Drug|HUDC_VT (Glucose 400mg)|Vaginal administration, two tablets once a day for 7 days
15937982|NCT03357666|Drug|HUDC_VT (Sodium chloride 200mg)|Vaginal administration, two tablets once a day for 7 days
15937983|NCT03357666|Drug|Placebo|Vaginal administration, two tablets once a day for 7 days
15937984|NCT03357653|Drug|Losartan group|Losartan 50 mg daily
15937985|NCT03357653|Drug|Placebo group|Placebo 1 pill daily
15937986|NCT03357640|Drug|combined oral contraceptive pills|one package of oral contraception (Cilest containing norgestimate 250 microgram + ethinyl estradiol 35 microgram)
15937987|NCT03357627|Drug|TAK-659|TAK-659 tablets.
15937988|NCT03357627|Drug|Venetoclax|Venetoclax tablets.
15937989|NCT03357614|Drug|Sulopenem|Antibiotic therapy for complicated UTI
15937990|NCT03357614|Drug|Sulopenem-Etzadroxil/Probenecid|Antibiotic therapy for complicated UTI
15937991|NCT03357614|Drug|Ertapenem|Antibiotic therapy for complicated UTI
15937992|NCT03357614|Drug|Ciprofloxacin|Antibiotic therapy for complicated UTI
15937993|NCT03357614|Drug|Amoxicillin-clavulanate|Antibiotic therapy for complicated UTI
15937994|NCT03357601|Behavioral|HIIT|The participant will perform HIIT where they will warm up for 3 minutes at 30% maximum heart rate (MHR), followed by 20 seconds of high intensity interval exercise at an all out intensity separated by 2 minutes of active recovery at 30% MHR. The interval will be repeated six times. Once completing all six intervals, participants will cool down for 3 minutes. This training program will be performed three times per week for five weeks.
15937995|NCT03357601|Behavioral|MCEET|The participant will perform MCEET, where they will warm up for 3 minutes at 30% maximum heart rate (MHR), followed by 14 minutes of moderate, continuous endurance exercise at 70% MHR. Participants will cool down for 3 minutes. This training program will be performed three times per week for five weeks.
15937996|NCT03357588|Other|Intensified monitoring|Intensified virological monitoring during first-line ART with viral load monitoring at month 6 of ART and 3-monthly thereafter, followed-up consecutively by point-of-care qualitative drug level testing and drug resistance testing in case of a viral load >1000 copies/mL, during first-line antiretroviral treatment (ART) for HIV-1 infection as prescribed by South African national guidelines.
15937997|NCT03357588|Other|Standard of care monitoring|Standard-of-care virological monitoring during first-line ART as described by WHO and South African National Department of Health ART guidelines, consisting of viral load monitoring at month 6 and 12 of ART and annually thereafter, followed-up by a repeat measurement within 3 months after a viral load >1000 copies/mL, during first-line antiretroviral treatment (ART) for HIV-1 infection as prescribed by South African national guidelines.
15937998|NCT03357575|Biological|Mesenchymal Stem Cells from adipose|inject mesenchymal Stem Cells from adipose
15937999|NCT03357575|Biological|Hyaluronic Acid|inject hyaluronic acid
15938000|NCT03357562|Device|lung MRI|lung MRI without contrast injection
15938001|NCT03357549|Other|Brief Motivational Intervention|The Brief Motivational Intervention is an intervention that use strategies are typical of patient-centered interventions. These strategies will help the interviewer to listen, to elicit important information, and to build rapport with the patient and should be used throughout the intervention. The four strategies are Open-Ended Questions, Affirmations, Reflections and Summaries. The objective of de BMI is to increase the client motivation to adopt healthy initiatives, and to increase their self-efficacy to reach their own objectives.
15938002|NCT03357549|Other|Breastfeeding education|It's a common educational intervention about breastfeeding. The women will receive the information by a leaflet with information about breastfeeding and community resources and they will receive verbal information during 20-30 minutes to resolve their doubts.
15938003|NCT03357536|Procedure|Human biological samples|"Blood sample
~Skin biopsy
~Saliva"
15938004|NCT03357523|Device|Omnilux new-U (Red LED)|The left wrist (including area of radial artery) will be illuminated with the Omnilux new-U (Red LED) light source, while the right wrist will not be illuminated
15938005|NCT03357523|Device|Omnilux new-U (Near infrared LED)|The left wrist (including area of radial artery) will be illuminated with the Omnilux new-U (Near infrared LED) light source, while the right wrist will not be illuminated
15938006|NCT03357523|Device|RESPeRATE|The subjects will be guided by a digital metronome to breath at 15, 10, and 6 breaths/min for 2 minutes each using the metronome function of the device RESPeRATE (InterCure, Israel) that guides breathing using musical tones played at selectable rhythm
15938007|NCT03357523|Device|Heating bag|Applying a standard 10X13 [cm] heating bag on the surface of the hand at 43-45 degree Celsius for 10 seconds
15938008|NCT03357497|Other|Very early mobilization|The patient will be mobilized by a physiotherapist in our postoperative care unit. The intervention uses the SOMS protocol.
15938009|NCT03357484|Procedure|Leukocyte- and platelet rich fibrin|Prior to surgery, two 9 ml glass-coated tubes (Intra-Spin, Intra-Lock International, Boca Raton, USA) of patient venous blood were collected. Tubes were transferred to a centrifuge (Andreas Hettich GmbH & Co.KG, Tuttlingen, Germany) and processed for 12 minutes at 2800 rpm to prepare L-PRF.
15938010|NCT03357484|Procedure|Blood clot|Natural blood clot formed within extraction socket
15938011|NCT03357471|Drug|e-Device|"Active Substance: Certolizumab Pegol
~Pharmaceutical form: Solution for injection
~Route of administration: subcutaneous injection by e-Device"
15938048|NCT03357159|Drug|Cyclophosphamide|In the first phase escalated doses of post-transplant cyclophosphamide up to a maximal dose of 50 mg/kg , the second phase will use the MTD cyclophosphamide dose identified in the first phase.
15974623|NCT03077724|Drug|Placebos|Olive Oil capsules
15938012|NCT03357458|Behavioral|Family Integrated Care|FICare is a dynamic psycho-educational intervention. The goal of FICare is a change in culture and practice that permits, encourages and supports parents in their parenting role while their infant is receiving health care in a Level II NICU. Underpinned by adult learning and change theories, FICare empowers parents to build their knowledge, skill and confidence so that the family is well-prepared to care for their infant long before discharge.
15938013|NCT03357445|Other|Avantage Reload cup|Patients receiving the Avantage Reload acetabular cup in total hip arthroplasty
15938014|NCT03357432|Other|gelatin, collagen, gummy dose|The study is aimed at determining if the same dose of gelatin, hydrolyzed collagen (administered in a beverage form) or a mixture gelatin/hydrolyzed collagen (administered in a gummy form) with a standard dose of vitamin C (50 mg) has a similar effect a marker of collagen synthesis (PINP). In a randomized, crossover design subjects consume 3 different nutritional supplements: (a) 15 of gelatin, (b) 15 hydrolyzed collagen (administered in a beverage form) or (c) 15 g of gelatin/hydrolyzed collagen mixture all with a standard dose of vitamin C (50 mg) 1 hour prior to exercise stimulus (6 minutes of jump rope). A baseline assessment with only the jump rope and no intervention will also be conducted prior to the interventions. Each intervention will be separated by a >24 hr washout. Following completion of exercise, subjects will remain in the lab in a rested state for the subsequent 4 hours. After 4 hours blood samples will be collected. Blood samples will be used for PINP analysis.
15938015|NCT03357419|Drug|Cephalexin|"The subjects will be randomized, at the operation day, to one of two treatment groups:
~group 1: prophylactic antibiotic
~group 2: placebo oral capsule
~Sealed envelopes, numbered according to the randomization dose, containing the drug or placebo will be prepared in advance and provided to the patient following randomization.
~Each patient will be given the randomized drug on admission, 30-60 minutes before the surgery, by the nurses."
15938016|NCT03357419|Drug|Placebo oral capsule|"The subjects will be randomized, at the operation day, to one of two treatment groups:
~group 1: prophylactic antibiotic
~group 2: placebo
~Sealed envelopes, numbered according to the randomization dose, containing the drug or placebo will be prepared in advance and provided to the patient following randomization.
~Each patient will be given the randomized drug on admission, 30-60 minutes before the surgery, by the nurses."
15938017|NCT03357406|Procedure|ultrasound implant site preparation|piezoelectric bone surgery will be used to create implant bone ostectomy
15938018|NCT03357406|Procedure|conventional implant site preparation|twist drills will be used to create implant bone ostectomy
15938019|NCT03357393|Drug|Midazolam|Midazolam is givenas sedation to the Control arm.
15938020|NCT03357393|Drug|Propofol-Lipuro|Propofol is given as sedation to both intervention arms.
15938021|NCT03357393|Drug|morphine-scopolamine|Given as premedication for the Control arm and one of the interventions arms.
15938022|NCT03357393|Drug|Glycopyrrolate|Given as premedication for one of the intervention arms..
15938023|NCT03357380|Drug|Semaglutide|Subcutaneously (under the skin) once-daily. Will be increased more or less every 4 weeks. It is expected that from week 16 until week 72 The participants take the maximum planned dose (0.4 mg) of study medicine.
15938024|NCT03357380|Drug|Placebo|Subcutaneously (under the skin) once-daily. Will be increased more or less every 4 weeks. It is expected that from week 16 until week 72 The participants take the maximum planned dose (0.4 mg) of study medicine.
15938025|NCT03357367|Device|TiVi system|"Device: TiVi system A galvanic current (0.1 mA) will be applied between 2 patches on the forearm of patient and protocol was repeated at 4 minutes.
~Microvascular response to current application (CIV) will be recorded by TiVi system 10 minutes later.
~Measurement of the value of skin blood flow (by TiVi system) at the stimulated area as compare to a non stimulated adjacent skin value taken as a reference Usual treatment will be recorded"
15938026|NCT03357354|Behavioral|collective workshop|diet, sports games, food budget, feeling of satiety and hunger, self-image
15938027|NCT03357341|Device|Mobile spirometer|Mobile spirometer will be used to measure FEV1 values weekly.
15938028|NCT03357341|Device|Device sensor|Sensors will be attached to rescue and maintenance inhalers to measure use of rescue medication and maintenance therapy.
15938029|NCT03357341|Drug|Salbutamol|Salbutamol MDI will be given as a rescue medication to be used on an as needed basis in this study.
15938030|NCT03357341|Device|Activity monitor|Subjects will be required to wear activity monitors daily to record their physical activity.
15938031|NCT03357341|Other|electronic diary card|Electronic diary card will be completed daily by subjects in COPD cohort.
15938032|NCT03357341|Other|CAT|Subjects will be required to complete CAT monthly.
15938033|NCT03357341|Other|ACT|Subjects will be required to complete ACT monthly.
15938034|NCT03357328|Other|Therapy light room|See group description
15938035|NCT03357328|Other|Standard light|See group description
15938036|NCT03357315|Biological|Mix vaccine|Each treatment: 0.5 ml /week, Subcutaneous injection of the deltoid muscle
15938037|NCT03357289|Biological|Mix vaccine|Each treatment: 0.5 ml /week, Subcutaneous injection of the deltoid muscle
15938038|NCT03357276|Biological|Mix vaccine|Each treatment: 0.5 ml /week, Subcutaneous injection of the deltoid muscle
15938039|NCT03357263|Biological|GC3114|High-dose Quadrivalent influenza vaccine
15938040|NCT03357263|Biological|GCFLU Quadrivalent|Quadrivalent influenza vaccine
15938041|NCT03357237|Other|medical device|"patients will be assigned, following an external randomization, to two groups:
~Intervention or experimental group: treatment regimen with oral rehydration solution and xyloglucan
~Control or reference group: treatment regimen with oral rehydration solution and placebo"
15938042|NCT03357224|Drug|Atezolizumab|Patients will receive atezolizumab 1200 mg IV Q3w for 1 year.
15938043|NCT03357185|Procedure|Femoral eversion|"The purpose of this database is to compile the data of patients followed at the René Dubos Hospital Center with symptomatic lower extremity arterial disease (AOMI) (Rutherford 2 to 5) who were operated on by the femoral tripod eversion technique.
~The database will include data on the operation, possible complications, clinical course of patients and medical and surgical follow-up."
15938044|NCT03357172|Biological|Blood Sample|Additional blood sample before graft, D0, D7, D15, D21, D30, D60, D90, D180, Y1, Y2
15938045|NCT03357172|Biological|Bone marrow aspiration|Additional bone marrow aspiration before graft, D30, D90, Y1
15938046|NCT03357172|Biological|Blood sample|Before donation
15938047|NCT03357172|Biological|Allogeneic hematopoietic stem cell sample|Allogeneic hematopoietic stem cell sample
15938049|NCT03357159|Drug|anti-human T-lymphocyte immunoglobulin (ATLG)|15mg/kg total (5mg/kg day) on days -3 to -1 pre transplantation
15938050|NCT03357146|Device|Optical coherence tomography angiography|OCTA scans per built-in device protocol
15938051|NCT03357133|Drug|Tirofiban|Tirofiban Injection after the alteplase intravenous thrombolysis
15938052|NCT03357133|Drug|Alteplase|Only alteplase intravenous thrombolysis
15938053|NCT03357120|Other|Follow-up after neoadjuvant chemotherapy|"Sequential plasma samples for ctDNA mutations analysis will be taken during the post-surgery visit (within 2-5 weeks after surgery) and every 6 months (+/- 1 month) thereafter for 5 years. In case of relapse patients will be proposed to participate to an optional research program with a blood test for ctDNA assessment and biopsies from a metastasis (when these biopsies are clinically indicated). Next Generation Sequencing (NGS) analysis will be performed on post-neoadjuvant chemotherapy residual tumor tissue samples. The mutations identified by NGS in residual tumor will be tracked in ctDNA using personalized digital PCR (dPCR) or by an NGS technique whose bioinformatics pipeline is adapted to the analysis of ctDNA.
~In case of relapse patients will be proposed to participate to an optional research program with a blood test for ctDNA assessment and biopsies from a metastasis (when these biopsies are clinically indicated)."
15938054|NCT03357107|Procedure|Transoral robotic surgery (TORS)|All patients underwent primary tumour resection with transoral robotic surgery (TORS) using the daVinci robot (Intuitive Surgical, Sunnyvale CA)
15938055|NCT03357081|Drug|CEUS or Contrast enhanced Ultrasound|Real time contrast enhanced ultrasound with Lumason. CEUS or Contrast enhanced Ultrasound
15938056|NCT03357068|Procedure|Control|Control side will receive only perforations on recipient site, which is the conventional technique for bone blocks graft.
15938057|NCT03357068|Procedure|Acid|Test side will receive treatment with citric acid (10%) for 30s at bone block surface and recipient site
15938058|NCT03357055|Drug|Ketamine|IV infusion of 0.25mg/kg of ketamine over 10 minutes before pneumatic tourniquet inflation. Throughout procedure patient will receive 0.25mg/kg of ketamine infusion.
15938059|NCT03357055|Drug|Normal saline|Control group will receive an intravenous (IV) infusion of 10 ml of normal saline in a 10 ml syringe over 10 minutes starting 10 minutes before pneumatic tourniquet inflation. Throughout the procedure, patients will receive 10ml/hour normal saline infusion until the end of operation
15938060|NCT03357042|Other|Aerobic exercise and balance retraining|Aerobic and balance exercises that gradually progress in intensity over the course of 8 weeks.
15938061|NCT03357042|Other|Standard of care|Normal concussion treatment; physical and cognitive rest
15938062|NCT03357029|Device|GammaCore Device|GammaCore will be administered using a handheld device the size of a mobile phone, which consists of a battery powered portable stimulator with a digital control user interface that controls the stimulation amplitude and two steel contact electrodes.
15938063|NCT03357029|Device|Sham Device|Sham device will be administered using a handheld device the size of a mobile phone, which consists of a battery powered portable stimulator with a digital control user interface that controls the stimulation amplitude and two steel contact electrodes. The sham device is identical in appearance, weight, visual and audible feedback, and user application and control but did not deliver electrical stimulations.
15938064|NCT03357016|Other|Training programs|High Intensity Interval Training program (HIIT) vs. Moderate Intensity Continuous Training program (MICT) vs. High Intensity Interval Training program + Resistance Training program (HIIT+RT)
15938065|NCT03357003|Other|Observational study|Comparison between O-desmethyltramadol/tramadol ratio and tramadol clinical efficiency and tolerance
15938066|NCT03356990|Dietary Supplement|Resistant Starch|"Dietary supplement will be taken every day for total of 2 weeks. Each participant will be take half the dose (one bag) of Hi-Maze 260 or High RS Gummy Chews in the morning and the other half dose (one bag) in the evening."
15938067|NCT03356977|Drug|Crisaborole ointment 2%|Applied BID
15938068|NCT03356964|Drug|follicle stimulating hormone|Follicle stimulating hormone( will be chosen according to ovarian reserve parameters in the study group the dosage will be reduced in the control group it will remain unchanged
15938069|NCT03356951|Procedure|TAR through anterior approach and subtalar fusion|Simultaneous total ankle replacement through anterior approach and subtalar fusion
15938070|NCT03356951|Procedure|TAR through lateral approach and subtalar fusion|Simultaneous total ankle replacement through lateral approach and subtalar fusion
15938071|NCT03356938|Behavioral|Sleep restriction|Restricted sleep to 5 hours / night for 5 days prior to sleep laboratory examination
15938072|NCT03356938|Behavioral|Sleep deprivation|Sleep deprivation during first night of sleep laboratory examination
15938073|NCT03356925|Diagnostic Test|Xpert Ultra Point of Care testing|The intervention is the point of care Xpert Ultra TB diagnostic compared to the standard of care centralised TB testing at a centralised facility
15938074|NCT03356912|Drug|Cabazitaxel|"Cabazitaxel drug products should be administered only by intravenous route.
~Prednison should be administered by oral route"
15938075|NCT03356912|Drug|Prednisone|Prednisone should be administred by oral route
15938076|NCT03356899|Drug|Low dose bupivacaine 0.5% (8mg)|8 mg hyperbaric bupivacaine with added 25 µg fentanyl to form a total volume of 2.1 ml
15938077|NCT03356899|Drug|High dose bupivacaine 0.5% (10mg)|10 mg hyperbaric bupivacaine with added 25 µg fentanyl to form a total volume of 2.5
15938078|NCT03356886|Procedure|Spinal Manipulative Technique|1) The application of a global low-amplitude and high-speed manipulation at the upper thoracic region between T1 and T5 levels in the dorsal decubitus position and 2) Techniques of post-anterior central mobilization applied for 30 seconds with an average of 30 repetitions in each lumbar vertebra, from L5 to L1, using grade II joint mobilization (patients positioned in the ventral decubitus position).
15938079|NCT03356886|Behavioral|Pain Neuroscience Education|All participants in the PNE + SMT group will initially receive a workshop on PNE in which different concepts of pain neuroscience and pain reconceptualization will be discussed and a power-point presentation with metaphors and animated videos on the topic will be employed. The PNE program will be held in 2 sessions of 40 minutes each. The topics of the intervention program will be divided into four thematic topics according to Explain Pain concepts.
15938080|NCT03356873|Drug|Vitamin D|Vitamin D supplementation
15938081|NCT03356873|Other|Placebo|Placebo
15938082|NCT03356860|Drug|Paclitaxel|80mg/m2 IV weekly from week 1 to week12
15938083|NCT03356860|Drug|Epirubicin|90 mg/m2 IV Q 2 weeks from week 14 to week 20
15938084|NCT03356860|Drug|Cyclophosphamide|600 mg/m2 IV Q 2 weeks from week 14 to week 20
15938085|NCT03356860|Drug|Durvalumab|Durvalumab 1500 mg IV at week 14 and 18
15938086|NCT03356847|Device|Fitting of ocular implant|Removal of natural lens and replacement with a SISA monofocal intraocular implant
15938087|NCT03356834|Drug|Tenofovir alafenamide(TAF)|25 mg tablet administered orally once daily
15938088|NCT03356834|Drug|Tenofovir disoproxil fumarate(TDF)|300 mg tablet administered orally once daily
15938089|NCT03356821|Biological|Mesenchymal Stem Cells|One dose of 50x10^6 bone marrow-derived allogeneic MSCs via the nasal route as soon as possible after confirmation of the stroke (in the middle cerebral artery), but within the first week of onset of presenting clinical symptoms. Within 30 minutes after cleaning the nose with saline, using standard procedures operative at the Neonatal Intensive Care Unit, the MSC will be delivered.
15938090|NCT03356808|Biological|Lung cancer-specific T cells|1 infusion, for 1x10^6~1x10^7 cells/kg via IV
15938091|NCT03356795|Biological|Cervical cancer-specific CAR-T cells|1 infusion, for 1x10^6~1x10^7 cells/kg via IV
15938092|NCT03356782|Biological|Sarcoma-specific CAR-T cells|1 infusion, for 1x10^6~1x10^7 cells/kg via IV
15938093|NCT03356769|Drug|Aspirin|low-dose of aspirin, 5mg/Kg/d, once every day, 25mg per tablets
15938094|NCT03356769|Drug|AED|maintain the dosages and the drugs throughout the 3-month observation time
15938095|NCT03356769|Drug|Placebo|placebo, 5mg/Kg/d, once every day, 25mg per tablets
15938096|NCT03356756|Diagnostic Test|simultaneous combined 18F-FDG PET and cardiac MRI imaging|Patients will undergo a research study performed with an integrated whole-body PET/MRI imaging system designed for simultaneous PET and MRI acquisition, immediately after standard of care PET/CT exam.
15938097|NCT03356743|Device|Spectrum Analysis|The ultrasound probe will be placed on the lung surface in several different directions to obtain the cross section with maximum diameter. Three spectral parameters including midband-fit (dB), intercept (dB), and slope (dB/MHz) will be calculated and compared between the tumor and the lung.
15938098|NCT03356730|Drug|Vitamin D|"Only patients with vitamin D deficiency / deficiency will be included in the study. Randomly, they will be divided into two groups. This group will receive vitamin D supplementation.
~Vitamin D3 - cholecalciferol, oral suspension in drops, will be prescribed as follows:
~• 5,000 IU / day - 10 drops per day for two months."
15938099|NCT03356730|Other|Placebo|"Only patients with vitamin D deficiency / deficiency will be included in the study. Randomly, they will be divided into two groups. This control group will receive placebo.
~Placebo (olive oil mint flavor), oral suspension in drops, will be prescribed as follows:
~• 10 drops per day for two months."
15938100|NCT03356717|Behavioral|educational intervention with observer tool|To assess if the use of an observer tool by observers during high fidelity simulation improves learning outcomes
15938101|NCT03356717|Behavioral|educational intervention|without observer tool
15938102|NCT03356704|Other|no intervention|Observational study
15938103|NCT03356691|Other|Complementary Spiritist Therapy|"Complementary Spiritist Therapy:
~Prayer: for 1 to 2 minutes.
~Spiritual education: reading and commentary of the Gospel according to Spiritism, about 7 minutes.
~Spiritist passe, for 2-min.
~Fluid therapy."
15938104|NCT03356691|Other|Prayer|Individuals will receive prayer during 1 to 2 minutes.
15938105|NCT03356691|Other|"Spiritist passe"|"Individuals will receive Spiritist passe during 5 to 10 minutes."
15938106|NCT03356691|Other|laying on of hands with intent to heal|Individuals will receive laying on of hands with intent to heal during 5 to 10 minutes.
15938107|NCT03356691|Other|Fluid therapy.|Individuals will receive fluid therapy.
15938108|NCT03356691|Other|No-fluid therapy.|Individuals will receive no-fluid therapy.
15938109|NCT03356678|Drug|Pralatrexate|"Patients treated with pralatrexate due to relapse or refractory disease after primary and/or salvage treatment. Relapse following an autologous stem cell transplant allowed.
~Patients treated with pralatrexate 30mg/m2 once a week for 6 weeks as part of a 7-week cycle. However, modified dose and/or schedule allowed."
15938110|NCT03356665|Diagnostic Test|Rapid diagnostic test (RDT)|The 4 rapid diagnostic tests (RDT) will be carried out on fresh blood from clinical suspects. Only those subjects that are positive in at least 1 RDT will 1) undergo tests on DBS (immune trypanolysis, ELISA and DNA detection); 2) undergo parasitological confirmation (reference standard) at inclusion.
15938111|NCT03356665|Diagnostic Test|Serological and molecular tests on DBS|Serological and molecular reference tests on dried blood spots (DBS) are carried out on RDT positive clinical suspects, which also undergo parasitological examination at inclusion (reference standard). If at least one of the serological or molecular reference tests on dried blood spots is positive, parasitological examination is repeated 3 and 6 months after inclusion. The combined results of parasitological examinations (at inclusion and if applicable at 3 and 6 months) serve as reference standard
15938113|NCT03356639|Drug|ASP6981|Oral
15938114|NCT03356639|Drug|Placebo|Oral
15938115|NCT03356626|Device|ULTRACISION Harmonic Scalpel|to use ULTRACISION Harmonic Scalpel when performing gastrectomy
15938116|NCT03356626|Device|Ligasure Maryland|to use Ligasure Maryland when performing gastrectomy
15938117|NCT03356626|Device|Thunderbeat|to use Thunderbeat when performing gastrectomy
15938118|NCT03356613|Other|Focus group|An researcher in psychology will lead focus group on research views for paramedical staff
15938119|NCT03356613|Other|test of the Geni tool|The GenI tool built on paramedic's view will be tested.
15938190|NCT03355963|Biological|Botulinum toxin type A 50 units|The treatment group B: received a single IC injection of BTX-A 50 units one day after the penile Doppler/trimix test.
15938191|NCT03355963|Biological|Botulinum toxin type A 100 units|The treatment group C: received a single IC injection of BTX-A 100 units one day after the penile Doppler/trimix test.
15938120|NCT03356600|Combination Product|Apatinib plus radiotherapy|"Apatinib:
~Within 1 week before radiotherapy, the dose of Apatinib were 500mg/daily .During radiotherapy,the dose of Apatinib were 250mg/daily.
~After radiotherapy, if the subject did not have a level 3 or above adverse reaction, investigators consider increasing doses to 500mg.
~Radiotherapy:
~The subjects with 1 to 4 metastases receive stereotactic radiosurgery or stereotactic radiation therapy ,and the subjects with more than 4 metastases receive stereotactic radiosurgery plus whole-brain radiation therapy"
15938121|NCT03356587|Drug|Abemaciclib|Patients will be instructed to take Abemaciclib orally at a dose of 200mg bid with a glass of water twice daily, in a fasting state or with a light fat-free meal, and as close as possible to the same time each day
15938122|NCT03356574|Procedure|Single-ventricle palliation surgery|Single-ventricle palliation surgery
15938123|NCT03356561|Biological|Ad26.ZIKV.001 5*10^10 vp|Participants will receive Ad26.ZIKV.001 at a dose of 5*10^10 vp via IM route.
15938124|NCT03356561|Biological|Ad26.ZIKV.001 1*10^11 vp|Participants will receive Ad26.ZIKV.001 at a dose of 1*10^11 vp via IM route.
15938125|NCT03356561|Biological|Placebo|Participants will receive placebo via IM route.
15938126|NCT03356509|Behavioral|Exercise|Exercise will be performed on a stationary bicycle ergometer.
15938127|NCT03356496|Device|AirLife 4000 cc incentive spirometry device|Incentive spirometry device provides improved lung expansion and respiratory muscle strength
15938128|NCT03356483|Drug|Psilocybin (0.25mg/kg)|Psilocybin is a naturally occurring hallucinogenic ingredient found in some varieties of mushrooms that can be produced synthetically. It is considered to be a serotonergic psychedelic.
15938129|NCT03356483|Drug|Niacin (250mg)|A medication used to treat high cholesterol, triglyceride levels, and niacin deficiency.
15938130|NCT03356470|Other|F-FDG PET/CT|F-FLT PET uses a thymidine analogue that accumulates in proliferating tissue. Proliferating tissue could include malignant lesions or immune cells. In this study, FLT PET/CT will be utilized as a molecular imaging tool to detect immune activation after administration of immune checkpoint blockade with pembrolizumab or nivolumab.
15938131|NCT03356457|Drug|Dichloroacetate|Dichloroacetate is an isoform-unspecific inhibitor of four regulatory pyruvate dehydrogenase kinases, which are able to reduce entry of substrates into mitochondria by reducing the conversion of pyruvate to acetyl-CoA. Drug will be administered to subjects with sever hypoglycemia as well as healthy non-diabetic subjects.
15938132|NCT03356457|Drug|Placebo oral capsule|A Placebo oral capsule identical in shape and color to those with active ingredient.
15938133|NCT03356444|Drug|Abiraterone Acetate|Abiraterone Acetate: orally, 1000mg, qd, plus with prednisone orally, 5mg, bid. Course of treatment: Stop the treatment until biochemical, clinical or radiographic progression occurs.
15938134|NCT03356444|Drug|Docetaxel|"Docetaxel: intravenously, 75 mg/m^2, over 1 h every 3 weeks, plus with prednisone, orally, 10 mg, qd.
~Course of treatment: Stop the treatment until biochemical, clinical or radiographic progression occurs. If no progression, stop until 10 cycles of traetment"
15938135|NCT03356431|Other|Supervised group exercise|"Quadriceps muscle isometric contraction in sitting position 1 set of 3-3 reps × 1 min hold.
~Isotonic quadriceps contraction with resistance band 3 sets of 10 reps x 1min hold.
~Isotonic hamstring contraction with resistance band 3 sets of 10 reps x 1min hold.
~Sit to stand exercise during 1 min.
~Dynamic stepping exercise (walking up and down one step/stair during 1 min).
~Standing calf stretch 3 x 20 sec.
~Standing quadriceps stretching 3 x 20 sec.
~Supine hamstring stretching 3 x 20 sec."
15938136|NCT03356431|Other|Home-based exercise|"Quadriceps muscle isometric contraction in sitting position 1 set of 3-3 reps × 1 min hold.
~Isotonic quadriceps contraction with resistance band 3 sets of 10 reps x 1min hold.
~Isotonic hamstring contraction with resistance band 3 sets of 10 reps x 1min hold.
~Sit to stand exercise during 1 min.
~Dynamic stepping exercise (walking up and down one step/stair during 1 min).
~Standing calf stretch 3 x 20 sec.
~Standing quadriceps stretching 3 x 20 sec.
~Supine hamstring stretching 3 x 20 sec."
15938137|NCT03356418|Other|WBV exercise group|The intervention will consist of a half-squat isometric whole-body vibration exercise with the platform configured at a frequency of 40 Hz and peak-to-peak amplitude of 4 mm. The sessions will be held 2 times a week, consisting of 4 sets of 1 and a half minutes of exercise on the platform. Rest intervals of 1 minute between sets will be respected.
15938138|NCT03356418|Other|Sham WBV exercise group|The intervention will consist of as half-squat isometric exercise , but the platform will remain off at all sessions. A device will be attached to the side of the platform in order to produce a sound, similar to the sound produced by the vibrating platform when it is in operation.
15938139|NCT03356392|Other|telephone call d90|telephone call on day 90 to assess the primary outcome (mRs d90)
15938140|NCT03356379|Diagnostic Test|Transcutaneous oximetry|Measurement of TcpO2 on calves and chests. Calculation of the DROP index (decrease from rest of oxygen pressure)on both calves
15938141|NCT03356366|Other|MRI 3T|Magnetic Resonance Imaging 3 Tesla
15938142|NCT03356366|Other|MRI 1,5T|Magnetic Resonance Imaging 1,5 Tesla
15938143|NCT03356366|Other|MRI 7T|Magnetic Resonance Imaging 7 Tesla
15938144|NCT03356353|Drug|Sildenafil Citrate|20 mg tablets
15938145|NCT03356327|Drug|Actitan F|A molecolar complex of Tannins and Flavonoids used for acute diarrhea in children
15938146|NCT03356327|Drug|Standard Oral Rehydration|Standard oral rehydration as suggested by ESPGHAN guidelines
15938147|NCT03356314|Other|MRI between 30-35 GA|MRI between 30-35 GA
15938148|NCT03356314|Other|Pediatric surgeon meeting|Pediatric surgeon meeting
15938149|NCT03356314|Other|Postnatal abdominal ultrasound, barium enema and upper gastrointestinal|Postnatal abdominal ultrasound, barium enema and upper gastrointestinal
15938150|NCT03356314|Other|+/- prophylactic surgery|+/- prophylactic surgery
15938151|NCT03356301|Device|Cardiac MRI|Non injected cardiac MRI exam
15938152|NCT03356301|Device|Applanation tonometry|Applanation tonometry and ECG
15938153|NCT03356275|Behavioral|Mindfulness for Resilience in Illness: Support for Parents|Mobile application focusing on emotional coping skills for parents of children and adolescents with chronic pain. Components of the module include: library of mindfulness meditations/relaxations; peer support videos; and psychoeducational information related to pain, stress, and mindfulness.
15938192|NCT03355950|Procedure|Lichtenstein Repair|Well defined Lichtenstein Repair for inguinal hernias
15938193|NCT03355950|Procedure|TEP Repair|Laparoscopic totally extraperitoneal repair for inguianal hernias
15938154|NCT03356249|Diagnostic Test|Next-Generation Sequencing|In 500 patients with suspected or proven sepsis or septic shock (according to the Sepsis-3 definitions), patients´ characteristics and routine blood parameters will be determined at sepsis onset as well as 72 hours afterwards. At the same time points, 2 sets of blood cultures and one blood tube for Next-Generation Sequencing (NGS)-diagnostics will be collected. An evaluation of outcome will be performed at 28 days after sepsis onset.
15938155|NCT03356223|Drug|Abemaciclib|"400mg/day with 2 doses of 200mg 12-hour apart For each 28-day cycle, a total of 56 doses of study drug will be dispensed.
~Route of administration : oral
~Duration of treatment until the patient experiences an unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent."
15938156|NCT03356210|Behavioral|Neurofeedback|The intervention will consist of 20 sessions of symptom-based NF tailored to the individual patient. Training will be conducted using the Othmer method of NF from EEGinfo, comprising bipolar, infra-low frequency training, with the inclusion of synchrony and alfa-/theta training as needed.
15938157|NCT03356184|Device|The Rhea Vital Sign Vigilance Device Group|The RHEA device and Philips Patient Monitor MX400 are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.
15938158|NCT03356184|Device|The Earlysense System Device Group|The reference device Earlysense 2.0 system(vital sign monitoring system) and Philips Patient Monitor MX400 are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.
15938159|NCT03356171|Procedure|Cardiac Coherence|"10 sessions of HRV-BF (45mn) weekly over 12 weeks. HRV-BF is a cognitive behavioural therapy consisting on stress management training based on breathing. We use the SYMBIOLINE PC software to record the heart rate variability biofeedback, with an infrared plethysmograph sensor. The sensor is put on the finger, and the patient's HRV pattern is displayed in real time.
~24 APA sessions (1.5h) bi-weekly over 12 weeks. Each session includes aerobic exercises (walk, step) and resistant exercises (muscular reinforcement). This program is built on previous cancer studies to make it effective."
15938160|NCT03356171|Procedure|Adapted Physical Activity|- 24 APA sessions (1.5h) bi-weekly over 12 weeks. Each session includes aerobic exercises (walk, step) and resistant exercises (muscular reinforcement). This program is built on previous cancer studies to make it effective.
15938161|NCT03356158|Biological|CPGJ602|Injection, q.w., 20 mg: 100 ml
15938162|NCT03356158|Biological|Cetuximab|Injection, q.w., 20 mg: 100 ml
15938165|NCT03356132|Device|Silimed® Textured Silicone Gel-Filled Breast Implant|Women undergoing primary and secondary breast augmentation using Silimed® Textured Silicone Gel-Filled Breast Implant.
15938166|NCT03356132|Device|Silimed® Polyurethane Foam Covered Silicone Gel-Filled Breast Implant|Women undergoing primary and secondary breast augmentation using Silimed® silicone gel-filled breast implants with polyurethane foam covered surface.
15938167|NCT03356119|Device|RemovAid device|The contraceptive implants of the subjects in this arm are removed by the new IMD.
15938168|NCT03356106|Device|Continuous positive airway pressure (CPAP)|A non-invasive positive pressure device that is used for the treatment of obstructive sleep apnea by splinting the collapsed upper airway during sleep
15938169|NCT03356093|Other|complete questionnaire|Patients were asked to complete a questionnaire at baseline, and week 1, 2, 3, 4, 5 and 6 after starting of radiotherapy.
15938170|NCT03356080|Drug|Decitabine|Decitabine,iv,0.1-0.2mg/kg, Day1-Day3 per week,up to 3 weeks
15938171|NCT03356080|Drug|Cytarabine|cytarabine, iv,15mg/m2 q12h, Day1-Day10
15938172|NCT03356080|Drug|All-transretinoic acid|All-transretinoic acid, 45mg/d Day4-Day6;15mg/d Day7-Day20
15938173|NCT03356080|Drug|G-CSF|G-CSF 300ug,sc,Day 0 until CR is achieved
15938174|NCT03356067|Procedure|Gastric endoscopic peroral pyloromyotomy|"G-POEM is, in principle, adaptation of POEM (per-oral endoscopic myotomy) in the stomach. The procedure consists of:
~Mucosal incision at the greater curvature 3-5 cm from the pylorus
~Submucosal tunnelling
~Finding pyloric sphincter
~Myotomy (2-3 cm) of the pyloric muscle
~Incision closure (endoclips or suture device)"
15938175|NCT03356067|Procedure|Esophago-gastro-duodenoscopy|Standard endoscopic examination of the upper GI tract with flexible endoscope
15938176|NCT03356054|Combination Product|R-DHAP|3 cycles q 3 weeks
15938177|NCT03356054|Drug|Brentuximab Vedotin|3 cycles q 3 weeks added to R-DHAP
15938178|NCT03356041|Other|Diabetic patients with neuropathy|Lifestyle modification will be assessed using summary of diabetes self-care activity
15938179|NCT03356028|Behavioral|Child and adolescent psychiatry and Epidemiology|psychosocial risk assessment questionnaire, structured diagnostic interview, pedopsychiatric questionnaire
15938180|NCT03356028|Other|salivary biological collection|Saliva sampling will be done using a specific kit
15938181|NCT03356028|Behavioral|qualitative analysis of the discourse|two semi-structured interviews, the first with the teenager alone, the second with the lone parents
15938182|NCT03356015|Drug|4L Polyethylene Glycol|4L group received double-dose PEG at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes.
15938183|NCT03356015|Drug|3L Polyethylene Glycol|3L group were instructed to drink 1L PEG at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes
15938184|NCT03356002|Device|C-Scan System|"Each subject will ingest the capsule within 30 days prior to colonoscopy. The results of the C-Scan review will be compared to the findings of colonoscopy.
~To establish the efficacy of C-Scan Capsule System and FIT in detecting patients with polypoid lesions ≥ 10mm, compared with Optical Colonoscopy
~To evaluate the safety of the C-Scan Capsule System procedure"
15938185|NCT03355989|Other|Conditional Cash Transfer|Conditional cash transfer provided via mobile airtime and easypaisa along with SMS reminders to increase immunization coverage and timeliness
15938186|NCT03355989|Other|SMS Reminder|Three SMS reminders for immunization provided before, at and after the due date respectively
15938187|NCT03355976|Drug|Nivolumab|240mg flat dose every 2 weeks
15938188|NCT03355976|Drug|Ipilimumab|Ipilimumab 1mg/kg every 6 weeks
15938189|NCT03355963|Other|saline injection|The control group: received an IC 1 ml saline injection one day after the penile Doppler/trimix test.
15938194|NCT03355937|Procedure|Sperm Chip|Sperm selection using by conventional or with sperm chip
15938196|NCT03355859|Biological|JWCAR029|Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JWCAR029. During JWCAR029 production, subjects will receive a conditioning chemotherapy regimen of cyclophosphamide and fludarabine for the purpose of lymphocytes depletion. After lymphodepletion, subjects will receive one dose treatment with JWCAR029 by intravenous (IV) injection.
15938197|NCT03355846|Drug|Centella|after meals twice a day for 15 days
15938198|NCT03355846|Drug|Proctocella|after hygiene treatment for 4 weeks;
15938199|NCT03355846|Drug|Flavonil® cps|after meals twice a day for 15 days
15938200|NCT03355846|Drug|Flavonil® Cream|"treatment for 4 weeks;
~."
15938201|NCT03355846|Drug|Rectalgan Mousse|for 4 weeks
15938202|NCT03355820|Procedure|Blood sampling for antibody determination|In order to assess the persistence of immune responses seven to eight years after the last vaccine dose against HPV-16/18, a blood sample (~5 mL) will be taken from all the subjects, at Day 1.
15938203|NCT03355807|Drug|Magnesium|The magnesium group (group Mg, n _ 40) received an additional infusion of MgSO4
15938204|NCT03355794|Drug|ribociclib|Oral capsule or liquid formula
15938205|NCT03355794|Drug|Everolimus|Oral tablets or dispersible tablets
15938206|NCT03355781|Device|magnetic resonance imaging (MRI)|brain imaging : structural anatomy, emotional congruence, anatomic connectivity, functional connectivity
15938207|NCT03355781|Procedure|Blood sample|27,5 ml of blood sample : genetic analysis and biobank
15938208|NCT03355781|Other|Clinical psychiatric evaluation|Global Assessment Scale(GAS),Mini International Neuropsychiatric Interview(MINI),Positive and Negative Symptoms Scale(PANSS),Family Interview for Genetic Studies(FIGS),Calgary Depression Scale for Schizophrenia(CDSS),extrapyramidal side effects evaluation or Simpson-Angus scale evaluation(ESRS),Apathy Evaluation Scale(AES-C),State-Trait Anxiety Inventory(STAI),Beck Depression Inventory(BDI-13),Eysenck Personality Questionnaire-Revised(EPQ-R),Assessment of Schizotypal Personality(SPQ),Emotion Regulation Questionnaire(ERQ),Emotional Reactivity Scale(ERS),Toronto Alexithymia Scale(TAS-20),social anhedonia scale(SAS),Childhood Trauma Questionnaire(CTQ),Clinical-administered Post Traumatic Stress Disorder Scale(CAPS),Wechsler Adult Intelligence Scale(WAIS-III),Trail Making Test(TMT),Pen and paper visuospatial working memory(DOT-test),impulsivity test(GoStop),Stroop test,National Adult Reading Test(NART),Wechsler Adult Intelligence Scale(WAIS-III),Facial Emotion Recognition task(FER)
15938209|NCT03355768|Drug|Romidepsin|Intravenous administration on a 28 day cycle
15938210|NCT03355768|Drug|Pralatrexate|Intravenous administration on a 28 day cycle
15938211|NCT03355755|Device|EksoGT with SmartAssist software|Intervention will consist of exercise using the EksoGT exoskeleton for supported walking. The EksoGT is a powered motorized orthosis intended to enable individuals who are experiencing muscular or neurological conditions affecting their lower extremities to perform ambulatory functions such as gait training.
15938212|NCT03355742|Device|XIENCE|Subjects who received XIENCE family stent systems will be included.
15938213|NCT03355742|Drug|DAPT|1-month clear subjects will receive 1 month of P2Y12 inhibitor and 12 months of aspirin after index procedure.
15938214|NCT03355716|Drug|bupivacaine|Bupivacaine 25 ml (0.25%)
15938215|NCT03355716|Drug|morphine|Morphine (3.0 mg)
15938216|NCT03355716|Drug|fentanyl|fentanyl (30.0 Mc)
15938217|NCT03355716|Drug|Ketamine:|ketamine (0.5 mg/kg).
15938218|NCT03355677|Procedure|Case finding Clinic|Case finding clinic - participants will be reviewed by a respiratory specialist team. Full respiratory history will be taken and physical examination will be preformed. The participant will then complete 3 quality of life and functionality questionnaires the MRC dyspnoea score and the COPD diagnostic questionnaire. They will then be asked to perform FeNO CO and spirometry measurements.
15938219|NCT03355677|Procedure|At Risk Case Clinics|Complex Case Clinic participants will be reviewed by a respiratory specialist team. Full respiratory history will be taken and physical examination will be preformed. The participant will then complete 6 quality of life and functionality questionnaires . They will then be asked to perform FeNO CO and spirometry measurements. Participants inhaler technique will be checked and any errors corrected. Smoking cessation advice and support will be given if necessary. Each participant will be given an individualised self management plan.
15938220|NCT03355677|Other|Usual Care|The control surgeries selected by the HHRA will continue with usual care.
15938221|NCT03355664|Drug|ACT|Artemether-lumefantrine (20/120 mg) as a fixed dose combination twice daily for 3 days according to weight plus low dose primaquine at hour 24
15938222|NCT03355664|Drug|TACT|Artemether-lumefantrine (20/120 mg) as a fixed dose combination twice daily for 3 days according to weight plus Amodiaquine (150mg) twice daily for 3 days according to weight plus low dose primaquine at hour 24
15938223|NCT03355651|Dietary Supplement|PROGEN|Dietary supplement based on plasma proteins, hydrolyzed collagen, a complex of Hyaluronic Acid - Chondroitin Sulfate (HC-15), and vitamin C
15938224|NCT03355638|Drug|Aflibercept Injection [Eylea]|patients received monthly 0.5 mg aflibercept intravitreal injections for 3 months, after which monthly injections were administered pro re nata
15938225|NCT03355638|Drug|Pranoprofen Eyedrops|Patients were given a bottle of eyedrops for self-administration of 0.1% pranoprofen (Pranoflog, Sifi SpA, Aci Sant'Antonio, CT, Italy). Pranoprofen dosage was 1 drop in the study eye, 3 times a day, over the 12-month study period
15938226|NCT03355638|Drug|Omega-3 Supplementation|Ppatients were given daily tablets of Omega-3 supplementation provided free of charge by the company (Azyr Mega; Sifi SpA, Aci Sant'Antonio, CT, Italy).
15938227|NCT03355612|Drug|Apatinib|Apatinib: 500 mg, qd, po, last 180 days
15938228|NCT03355612|Drug|XELOX|Capecitabine:1000 mg/m2 bid d1-14 q3w, Oxaliplatin:130 mg/m2 d1 q3w
15938229|NCT03355599|Other|3d camera|3 D camera and associated software that introduces measurement and monitoring of wounds as a specific intervention
15938230|NCT03355586|Combination Product|Electromagnetic navigation|Electromagnetic navigation combined with use of radial EBUS probe and Rapid On Site Evaluation of Histology for diagnosis of peripheral pulmonary nodules.Controlled by cone beam CT.
15938232|NCT03355560|Drug|Nivolumab|Nivolumab 480 mg IV infusion
15938264|NCT03355287|Other|Traditionally Threshed Teff (TTT)|The intervention will take place for 7 months in Debre Zeit where the the arm will be fed injera based on teff that are threshed traditionally
15975190|NCT03073200|Drug|Etanercept|Administered SC
15938233|NCT03355547|Other|questionnaire about the severity of their symptoms of upper respiratory tract infection|Before the operation, the researcher interviews the parents of the pediatric patients to check whether they have the upper respiratory tract infection and asks them to fill out a questionnaire about the severity of their symptoms. The questionnaire consists of 8 types of symptom about upper respiratory infections and each symptom was checked from 0 to 3 according to severity by their patients.
15938234|NCT03355534|Drug|Intravenous dexmedetomidine|drug is intravenously infused to patients
15938235|NCT03355534|Drug|nasal dexmedetomidine|drug is nasally given to patients
15938236|NCT03355534|Drug|intravenous saline|saline is given to patients intravenously
15938237|NCT03355534|Drug|nasal saline|normal saline is given to patients nasally
15938238|NCT03355521|Other|Nordic Walking|Nordic walking Training the total period of training was composed by 9-week of walking with poles, two sessions per week. The cycles were divided into four microcycles composed of three training sessions. Each training session took 60 min. Free walking aerobics training was used during the training period. These exercises were performed alternating volume and intensity. The training session was divided into three stages: (a) stretching, joint mobility, and heating; (b) main part (FW); (c) return to the calm and ultimate stretching.
15938239|NCT03355521|Other|Free Walking|Free walking Training The total period of training was composed by 9-week of walking without poles, two sessions per week. The cycles were divided into four microcycles composed of three training sessions. Each training session took 60 min. Free walking aerobics training was used during the training period. These exercises were performed alternating volume and intensity. The training session was divided into three stages: (a) stretching, joint mobility, and heating; (b) main part (FW); (c) return to the calm and ultimate stretching.
15938240|NCT03355508|Device|pucture in the arteriovenous fistula|"The compression time will be measured with a stopwatch so that it is objective and accurate, although the compression times range from minute to minute.
~An initial 2-week observation phase (phase 1) will establish a reference time for each patient using the most common puncture technique in the department: bevel up.
~We will evaluate the patient's reference time by counting the time of compression using a stopwatch for 2 weeks (ie 6 sessions) and we will take an average.
~A draw will determine for each patient the order in which the direction of the needles will be used.
~After this determination of the reference time, the patient will enter two successive phases where it will be punctured bevel up (phase 2) and then down (phase 3) or vice versa following the draw."
15938241|NCT03355495|Procedure|Colonoscopy - Position Change|Colonoscopy is the gold standard for detecting precancerous lesions. We are proposing that changing positions will provide better visualization for detecting such lesions. We will test our intervention of patients positioned in the Right Lateral Decubitus Position to the gold standard of Left Lateral Decubitus Positioning, hypothesizing better visualization in the right lateral decubitus position.
15938242|NCT03355482|Drug|Methylprednisolone|160mg IM at baseline
15938243|NCT03355482|Drug|Placebos|IM saline injection at baseline
15938244|NCT03355469|Drug|Low Intensity Exercise + Metformin|Low Intensity exercise (LoEx) measured by a percentage of maximal heart rate in combination with metformin.
15938245|NCT03355469|Drug|High Intensity Exercise + Metformin|High Intensity exercise (HiEx) measured by a percentage of maximal heart rate in combination with metformin.
15938246|NCT03355469|Drug|Low Intensity Exercise + Placebo|Low Intensity exercise (LoEx) measured by a percentage of maximal heart rate in combination with placebo.
15938247|NCT03355469|Drug|High Intensity Exercise + Placebo|High Intensity exercise (HiEx) measured by a percentage of maximal heart rate in combination with placebo.
15938248|NCT03355456|Procedure|Radiofrequency ablation|Ablation procedure to eliminate atrial fibrillation
15938249|NCT03355443|Procedure|Retroflexion|Retroflexion technique in colonoscopy means turning the colonoscope tip 180 degree in order to look backward in the colon and rectum.
15938250|NCT03355443|Procedure|Re-examination|Re-examination in colonoscopy means examining the cecum and ascending colon twice in the routine fashion.
15938251|NCT03355430|Procedure|combined corneal wavefront-guided transepithelial photorefractive keratectomy (tPRK)|After at least 1 month (average 2.7 ± 1.1 months; range 1 to 4 months), all patients were scheduled for combined corneal wavefront-guided tPRK and accelerated CXL treatment. tPRK between the corneal ring segments was performed using an excimer laser (Amaris 1050 Excimer Laser platform; Schwind eye-tech-solutions GmbH and Co KG, Kleinostheim, Germany).
15938252|NCT03355430|Procedure|accelerated corneal collagen cross-linking (CXL)|After at least 1 month (average 2.7 ± 1.1 months; range 1 to 4 months), all patients were scheduled for combined corneal wavefront-guided tPRK and accelerated CXL treatment. tPRK between the corneal ring segments was performed using an excimer laser (Amaris 1050 Excimer Laser platform; Schwind eye-tech-solutions GmbH and Co KG, Kleinostheim, Germany).
15938253|NCT03355417|Other|OT-SI|Occupational therapy using a sensory integration approach (OT-SI) 3x per week for 10 weeks. A typical session will be 1 hour (total of 3 hours per week).
15938254|NCT03355404|Other|standing patient|patient goes standing to the surgery room
15938255|NCT03355378|Procedure|gum chewing|chewing gum orally for 30 minutes
15938256|NCT03355365|Biological|Intrathecal MSC-NP injection|MSC-NPs represent a neural subpopulation of MSCs from bone marrow with reduced pluripotency and minimized risk of ectopic differentiation, thus are likely to be more suitable for CNS delivery. Importantly, characterization of MSC-NPs demonstrated their immunoregulatory and trophic properties, and MSC-NPs derived from MS and non-MS patients alike were therapeutically viable.
15938257|NCT03355365|Other|Intrathecal saline injection|Placebo
15938258|NCT03355352|Drug|Sufentanil|Sufentail sublingual 15ug nanopills
15938259|NCT03355339|Device|Binasal occlusion|Binasal occlusion glasses
15938260|NCT03355339|Device|No binasal occlusion|Non-occluded glasses
15938261|NCT03355326|Drug|Glycerin Suppository|Glycerin suppository is given once daily beginning after conditions described are met and continued until discontinue conditions are met.
15938262|NCT03355313|Radiation|Low level Light therapy|Laser will be administered for 10 seconds on four intraoral points and four extraoral points in the region of the parotid glands bilaterally as well as one intraoral point and one extraoral point in the regions of the submandibular and sublingual glands.
15938263|NCT03355300|Drug|Cannabidiol Oral Solution|An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
15976543|NCT03063047|Other|PD21872AA|A 100s size menthol cigarette.
15938265|NCT03355287|Other|Lab Threshed Teff (LTT)|The intervention will take place for 7 months in Debre Zeit where this arm will be fed injera from teff that is threshed using a modern thresher.
15938266|NCT03355287|Other|Fortified Lab Threshed Teff (FTT)|The intervention will take place for 7 months in Debre Zeit where this arm will be fed injera from teff that is threshed using a modern thresher. In addition, they will receive Ferrous sulfate drops
15938267|NCT03355274|Diagnostic Test|Transcutaneous Oximetry|"The examination of transcutaneous Oximetry dynamic measurement with palmar face of both forearms during two consecutive maneuvers known as the candlestick (hands up)."
15938268|NCT03355274|Diagnostic Test|Photopletysmography|Maneuvers are repeted with the photoplestysmography sensors and in front of a Kinect camera.
15938269|NCT03355274|Other|Questionnaires of Quality of Life (QoL)|Each subject complete 2 QoL questionnaires : Sf-12 (Short Form 12) and DASH (Disabilities of the Arm, Shoulder and Hand).
15938270|NCT03355261|Procedure|complete remission (CR) group|According to the RECIST 1.1, 32 patients were allocated into the complete remission (CR) group based on their responses to neoadjuvant chemotherapy (NAC).
15938271|NCT03355261|Procedure|partial remission (PR) group|According to the RECIST 1.1, 61 patients were allocated into the partial remission (PR) group based on their responses to neoadjuvant chemotherapy (NAC).
15938272|NCT03355261|Procedure|stable disease (SD) group|According to the RECIST 1.1, 12 patients were allocated into the stable disease (SD) group based on their responses to neoadjuvant chemotherapy (NAC).
15938273|NCT03355261|Procedure|progressive disease (PD) group|According to the RECIST 1.1, 5 patients were allocated into the progressive disease (PD) group based on their responses to neoadjuvant chemotherapy (NAC).
15938274|NCT03355248|Other|Oxycodone Acetaminophen|Decrease in opioid prescribing for post-operative cesarean pain management
15938275|NCT03355222|Behavioral|Promotion of chicken eggs|Community is provided with chickens and young children are to receive one egg a day; selected mothers will consume eggshell.
15938276|NCT03355209|Drug|ZX008 0.2 or 0.8 mg/kg/day|ZX008 drug product is an oral aqueous solution of fenfluramine hydrochloride. The product is sugar free and is intended to be compatible with a Ketogenic Diet.
15938277|NCT03355209|Drug|Matching Placebo|Placebo will be administered twice a day (BID) in equally divided doses.
15938278|NCT03355196|Drug|LRX712|Ascending single dose on Day 1
15938279|NCT03355196|Drug|Placebo|Ascending single dose on Day 1
15938280|NCT03355183|Other|Isokinetics|Isokinetics, or accommodating resistance, is a form of exercise where a person provides a maximum muscle contraction against a resistance or lever arm, (isokinetic dynamometer) at a fixed speed through a given range of motion. This type of muscle action can be done either concentrically or eccentrically at the given joint.
15938281|NCT03355170|Combination Product|Lansoprazole/Domperidone|Experimental
15938282|NCT03355170|Drug|Lansoprazole|Active comparator
15938283|NCT03355157|Drug|Palbociclib / Chemotherapy (capecitabine, epirubicin, paclitaxel, vinorelbine) / Endocrine therapy (exemestane, fulvestrant, letrozole, tamoxifen)|Drug intervention
15938284|NCT03355144|Dietary Supplement|Daily Supplementation with Coffee|"At the beginning of study week 2 (study day 8), two coffee machines (one Nespresso Inissia and one Hamilton Beach 46205 12 Cup Programmable Coffee Maker) will be installed in the resident work rooms at each site.
~Subjects will be provided with free coffee beans, milk, cream, sugar and sweetener"
15938285|NCT03355131|Behavioral|Adapted NASA's Mission X program|8 Weeks Adapted National Aeronautics and Space Administration's (NASA's) Mission X (MX) program
15938286|NCT03355118|Other|General anaesthesia and major surgery|The effect of general anaesthesia and surgery on oxygen transport and how it relates to outcome
15938287|NCT03355105|Other|Objective adjustment of the MI/E exsuflation pressure and evaluation of cough effort|The exsufflation pressures will be progressively increased starting from -20 cmH2O with 10 cmH2O increments up. 3 coughing operations will be realised for each level, until obtention of 10% of AUC decrease or a PCF collapse of at least 10% over the last 2 levels and without exceeding -70 cmH2O. The selected landing will be the one allowing the largest PCF without presence of collapse. An intermediate bearing between 2 bearings may be tested in order to approach an optimum adjustment threshold less than 5 cmH2O.
15938288|NCT03355105|Other|Subjective adjustment of the MI/E exsuflation pressure and evaluation of cough effort|"The exsufflation pressures will be gradually increased from -20 cmH2O, with 10 cmH2O increments up to a maximum of -70 cmH2O. The selected level will be the one selected both by the patient and the clinician therapist and considered as making it possible to obtain the most effective cough according to the return of the patient."
15938289|NCT03355092|Device|vBloc Therapy|The vBloc device will be placed using a laparoscopic procedure. The participants will be followed according to standard clinical practice and vBloc therapy protocol under the supervision of study surgeons. . Pre-operative testing will be conducted per surgeon's evaluation. Participants will receive weight management education according to the vBloc Therapy protocol.
15938290|NCT03355079|Drug|SmofKabiven® E|In the intervention arm, SmofKabiven® E, with or without addition of Suppliven®, Vitalipid® Adult and/or Soluvit®, will be administered in addition to standard of care oral nutrition as per dietary counseling, whereas in the control arm, oral nutrition as per dietary counseling is the primary nutritional support.
15938291|NCT03355066|Drug|SM08502|SM08502 tablets to be administered orally.
15938292|NCT03355053|Drug|Dexmedetomidine|See description of study arms
15938293|NCT03355040|Other|induction of labour|induction of labour
15938294|NCT03355027|Drug|Alirocumab 150 MG/ML|Dosing to be performed by subcutaneous injection in clinic
15938295|NCT03355027|Drug|Ezetimibe 10Mg Tablet|Patients will be instructed to take once daily at night.
15938296|NCT03355027|Drug|Atorvastatin 40Mg Tablet|Patients will be instructed to take once daily at night. Atorvastatin will be the preferred statin option for those with eGFR < 60 ml/min/1.73m2. Patient may be required to complete a 4 week run-in period on a statin prior to entering the study (dependent on eligibility)
15938297|NCT03355027|Drug|Atorvastatin 80Mg Tablet|Patients will be instructed to take once daily at night. Atorvastatin will be the preferred statin option for those with eGFR < 60 ml/min/1.73m2. Patient may be required to complete a 4 week run-in period on a statin prior to entering the study (dependent on eligibility)
15938427|NCT03354026|Drug|AICH-without PXZY|AICH-2(herbal medicine without Hirudo, Tabanus) (6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days
15938298|NCT03355027|Drug|Rosuvastatin 20Mg Tablet|Patients will be instructed to take once daily at night. Rosuvastatin only to be prescribed if atorvastatin and simvastatin are not previously tolerated. Patient may be required to complete a 4 week run-in period on a statin prior to entering the study (dependent on eligibility)
15938299|NCT03355027|Drug|Rosuvastatin 40Mg Tablet|Patients will be instructed to take once daily at night. Rosuvastatin only to be prescribed if atorvastatin and simvastatin are not previously tolerated. Patient may be required to complete a 4 week run-in period on a statin prior to entering the study (dependent on eligibility)
15938300|NCT03355027|Drug|Simvastatin 80mg|Patients will be instructed to take once daily at night. Patient may be required to complete a 4 week run-in period on a statin prior to entering the study (dependent on eligibility)
15938301|NCT03355014|Drug|Combination of gemigliptin/metformin HCl sustained release 50/1000mg|Gemigliptin/Metformin HCl extended release 25/500mg 2tablets
15938302|NCT03355014|Drug|Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg|Zemiglo 50mg 1 tablet Glucophage XR 2 tablets
15938303|NCT03355001|Device|Monosyn® Quick|"Mucosal sutures in the facial and oral
~Dermal sutures, particularly in pediatrics
~Episiotomy
~Circumcision"
15938304|NCT03354988|Other|Physical exercise group|For the exercise group, systematic physical activity programs consisting of range-of-motion exercises with gentle compression, extension and flexion of all joints of both bilateral upper extremities; including the shoulder, elbow, and wrist and lower extremities; including the hip, knee and ankle, with a total of 12 joints. Each activity was about 10 min a day and was carried out 5 times per week for 4 weeks. This program was started after 1 week of birth. Physical activity continued until discharge from hospital
15938305|NCT03354988|Other|Control group|Other routine care activities such as bathing (every day) and kangaroo care (30 minutes/day), will be done for both the control
15938306|NCT03354975|Behavioral|Experiential Training|Participants in the experiential training will be provided with information about using exposure therapy to treat patients with anxiety via lecture-style teaching. Then, they will themselves undergo a one-session phobia treatment for spiders.
15938307|NCT03354975|Behavioral|Training-As-Usual|The training-as-usual condition will incorporate passive and active learning components. The first half of the training will include lecture-style teaching about using exposure therapy to treat patients with anxiety. The second half of training will incorporate active learning components (e.g., role plays) to reinforce concepts discussed in the first half of training.
15938308|NCT03354962|Combination Product|Nivolumab + Ipilimumab|Nivolumab + Ipilimumab alone (standard dosage regimen)
15938309|NCT03354962|Combination Product|Combined treatment schema|SBRT (recommended optimal dose) with Nivolumab + Ipilimumab (standard dosage regimen)
15938310|NCT03354949|Other|Measurement of sitting postural control of the adult (MCPAA)|"The Adult Seated Postural Control Measure 2.0 (MCPAA 2.0) is a clinical evaluation tool for sitting postural control of adult clients using a locomotion aid. It thus allows the evaluation of the two variables inherent to the postural control sit, the alignment of body segments and the influence between movement and posture.
~It can also be used to evaluate the changes in seated postural control due to changes over time or to an adaptation of the sitting posture.
~Assessment of wheelchair pain in the spine and ischia by a self-evaluation scale (EVA).
~the speed of propulsion by a wheelchair."
15938311|NCT03354936|Biological|Blood sample|Blood samples will be collected to constitute cell bank, plasma bank, serum bank, DNA bank in order to meet the objectives of this substudy and possibly for complementary research
15938312|NCT03354923|Behavioral|PEERS intervention|PEERS is a 14-week manualized social skills treatment program that targets the friendship skills of adolescents with ASD. In the Israeli adaptation of PEERS, two meeting were extended. An adolescents group will be held concurrently with the parents group in different rooms. Both groups will begin the session with homework review, followed by a didactic social skills lesson, utilizing the teaching methods of modeling and role-playing. In order to practice the newly learned social skills,a behavioral rehearsal interaction will be assigned in the adolescents group. Finally,Socialization homework assignments designed to address further mastery and generalization of newly learned skills within the natural social environment will be assigned too.
15938313|NCT03354910|Behavioral|House Call|60 to 90 minute home based educational intervention which will be administered by a health educator.
15938314|NCT03354910|Behavioral|Peer Mentorship|A National Kidney Foundation Peer Mentor will be assigned to the participant to provide contact and support to study participants.
15938315|NCT03354897|Drug|Torasemide 5Mg Tablet|16 weeks treatment
15938316|NCT03354884|Drug|cabozantinib|cabozantinib 60 mg orally once daily
15938317|NCT03354858|Procedure|Follicular flushing|Repeated follicle flushing up to 5 times using a double lumen needle for oocyte recovery
15938318|NCT03354845|Other|Deprescribing intervention|Pharmacists assessed the appropriateness of target symptomatic medications and potential for discontinuation. After discussion with pharmacists and consideration of patients' and caregivers' preferences regarding discontinuation or dose reduction, doctors would deprescribe these symptomatic medications. Symptom recurrence, adverse drug withdrawal events (ADWEs), and the need for drug re-initiation or initiation of new symptomatic control medications after deprescribing were monitored and documented in the 1st, 2nd and 6th weeks.
15938319|NCT03354832|Other|Foetal death|A midwife is in charge to interview the mother during the month following the lost of her infant.
15938320|NCT03354832|Other|New-born death|A midwife is in charge to interview the mother during the month following the lost of her infant.
15938321|NCT03354832|Other|Birth control for foetal death|A midwife is in charge to interview the mother during her hospital stay
15938322|NCT03354832|Other|Birth control for new-born death|A midwife is in charge to interview the mother during her hospital stay
15938323|NCT03354819|Behavioral|Modified MBCT|"Compared with the original protocol of Mindfulness-based Cognitive Therapy (Segal et al., 2002), the modified MBCT protocol in this pilot study has the following changes:
~Outline:
~Session 1 Awareness and automatic pilot:
~Session 2 Living in our head
~Session 3 Gathering the scattered mind
~Session 4 Recognizing aversion & allowing
~Session 5 Thoughts are not facts
~Session 6 Take care of myself
~Session 7 Maintaining and extending new learning"
15938363|NCT03354520|Behavioral|Standard Videos|Patients in the control arm will also receive an iPad, providing access to standard online OSA health information (e.g., National Sleep Foundation) in an equivalent dose as in the intervention arm using pre-selected automatic alerts to access the website
15938324|NCT03354819|Behavioral|SIRE on dementia|"The SIRE program includes routine education sessions on dementia care, caregiver skills training, and group sharing on caregiving tasks.
~Outline:
~Overview of dementia
~Pharmacological and non-pharmacological treatment of dementia
~BPSD in dementia care
~Person center care
~Advance planning in people with dementia
~Principle of mindfulness
~Non-pharmacological intervention on stress reduction"
15938325|NCT03354806|Procedure|Continuous peripheral nerve blocks|6 weeks-ropivacaine treatment delivered by continuous peripheral nerve blocks Transcutaneous oxygen measurement is assessed on day 2, week 3 and week 6 under atmospheric and hyperbaric conditions
15938326|NCT03354806|Procedure|Analgesic treatment|6 weeks-analgesic treatment according to WHO's pain relief ladder Transcutaneous oxygen measurement is assessed on day 2, week 3 and week 6 under atmospheric and hyperbaric conditions
15938327|NCT03354793|Other|Survey on first pregnancy after endometriosis diagnosis|Obstetric complications were noted
15938328|NCT03354793|Other|Survey on first pregnancy|Obstetric complications were noted
15938329|NCT03354780|Other|Survey on first pregnancy after endometriosis diagnosis|rate of miscarriage was noted
15938330|NCT03354780|Other|Survey on first pregnancy|rate of miscarriage was noted
15938331|NCT03354767|Procedure|Aortic and aortic valve surgery|
15938332|NCT03354754|Drug|LYS228|LYS228 IV infusion every 6 hours
15938333|NCT03354754|Drug|Standard of care therapy|IV infusion of standard of care antibiotics
15938334|NCT03354741|Other|laser therapy|stimulation of the acupuncture point P6 by laser therapy
15938335|NCT03354728|Other|Laboratory Biomarker Analysis|Correlative studies
15938336|NCT03354728|Biological|Multi-peptide CMV-Modified Vaccinia Ankara Vaccine|Given IM
15938337|NCT03354715|Device|Rapid prototyping Denture base|The introduction of rapid prototyping (RP)Stereo lithography (SLA) technology, which mainly depends on addition of layers of materials which would be polymerized using a light curing unit. It consists of a bath of photo polymerized liquid and ultraviolet unit for curing these layers, that would bond to each other till forming the full object. SLA has many advantage as high accuracy, high mechanical strength, smooth surface finish with close tolerance and fine details printing, but it has some limitation as it is only limited Material, in addition to the high material and equipment cost.
15938338|NCT03354715|Device|Heat Cured Conventional Complete Denture|it is the main treatment for most of completely edentoulous Cases
15938339|NCT03354702|Other|Aerobic|Aerobic exercise Patients performs 8 sessions of aerobic exercise (walking / running),with monitoring and 8 sessions without monitoring totaling 16 sessions and patients have medical appointment with psychiatrist and make psychotherapy sessions.
15938340|NCT03354702|Other|Stretching|Stretching Patients performs 8 sessions of stretching, with monitoring and 8 sessions without monitoring totaling 16 sessions and patients have medical appointment with psychiatrist and make psychotherapy sessions.
15938341|NCT03354689|Radiation|Scintigraphy|Scintigraphy
15938342|NCT03354676|Other|MetS+|Data processing from Patient Medical Files
15938343|NCT03354676|Other|MetS-|Data processing from Patient Medical Files
15938344|NCT03354663|Device|TactiCath SE|Ablation to achieve pulmonary vein isolation.
15938345|NCT03354650|Diagnostic Test|blood culture|blood culture to determine causative organisms of neonatal sepsis
15938346|NCT03354637|Drug|ATI-50002 high dose|Topical solution
15938347|NCT03354637|Drug|ATI-50002 low dose|Topical solution
15938348|NCT03354637|Drug|Placebo|Topical solution
15938349|NCT03354624|Drug|Sterile solutions of recombinant human nerve growth factor (NGF)|The intramuscular injections of NGF cause muscle soreness.
15938350|NCT03354611|Radiation|Contrast Enhanced Cone Beam Breast CT Scan|"Pre-contrast scan
~Begin contrast injection (and saline chaser)
~Post-contrast Scan. Start time of post-contrast CE-CBBCT scan is 90-200 seconds after start of injection, depending on method of contrast delivery (bolus vs hand injection)"
15938351|NCT03354611|Drug|Contrast Dye, Iodinated|"1.5-2ml/kg body weight (100 ml maximum) of a low osmolar, nonionic, 300-350 mgI/ml iodinated contrast agent, will be injected at a rate of ~2.0 ml/s, for a total injection time of 30-60 seconds (for a 50 kg subject). This will be immediately followed by a saline chaser from 20 to 40 ml at ~2 ml/s (20 seconds) to maximize dynamic enhancement."
15938352|NCT03354598|Drug|Sulopenem-Etzadroxil/Probenecid|Treatment of uncomplicated urinary tract infection
15938353|NCT03354598|Drug|Ciprofloxacin|Treatment of uncomplicated urinary tract infection
15938354|NCT03354585|Behavioral|Meditation training|A well-validated brief mindfulness-based mental training regimen [20 min/session(s)] will be used to teach patients to independently practice mindfulness. Participants will be asked to close their eyes acknowledge distracting thoughts and feelings.
15938355|NCT03354585|Behavioral|Meditatin training|A well-validated brief meditation-based mental training regimen [20 min/session(s)] will be used to teach patients to independently practice mindfulness. Participants will be asked to close their eyes acknowledge distracting thoughts and feelings.
15938356|NCT03354585|Behavioral|Book Listening Control|Study volunteers will listen to The Natural History and Antiquities of Selborne throughout the intervention.
15938357|NCT03354572|Drug|Acetyl cysteine|acetyl cysteine 150 mg/kg prior to surgery
15938358|NCT03354572|Drug|Placebos|saline 0.9% prior to surgery
15938359|NCT03354546|Diagnostic Test|Frailty index|A frailty index composed of variables from health administrative data that cover multi-system health issues. Deficits will be coded as present or absent, and the number of deficits present will be divided by the total number of deficits present to provide an overall score between 0-1.
15938360|NCT03354533|Drug|L-fucose|Oral ORL-1F
15938361|NCT03354520|Behavioral|Tailored Videos|web-based OSA messages (videos featuring role models and coaching advice using motivational enhancement) addressing OSA barriers within a health literacy framework--to decrease cognitive load and render messages understandable and actionable. OSA messages were tailored based on focus group data in the previous study (group tailoring).
15938362|NCT03354520|Behavioral|OSA Treatment|Web-based platform delivering messages promoting OSA self-efficacy. . All patients will view the introductory video, followed by the video cluster: Sleep, Health, and Well-Being; Sleep-Heart Health; Lifestyle Changes; and Sleep Hygiene.
15938364|NCT03354507|Dietary Supplement|Sodium bicarbonate|Sodium bicarbonate. See arms.
15938365|NCT03354494|Drug|Desogestrel (DSG) and Corifolitropin (FSH-CTP) Alfa|
15938366|NCT03354481|Behavioral|Arithmetic facts solving|The experiment will contain several tasks. The main one will be a computerized task on arithmetic facts where participants will have to solve simple additions. There will also be three additional tasks: a processing speed task where the participant will have to tell the orientation of an arrow as fast as possible, a visuo-spatial task where the participant will have to reproduce a tapping block sequence and an arithmetic task where the participant will try to solve a maximum of operations in a limited time.
15938367|NCT03354468|Behavioral|fall prevention program|fall prevention program in orthopedic department, consisting of 1) Seven examples of risk factors which might cause falls (diseases and medications, movement, cognitive behavior, vision, continence, nutrition, and the room and surroundings), 2) Methods to detect the risk factors, and 3) Measures to avoid falls or protect the patient in case of a fall.
15938368|NCT03354455|Device|Repetitive transcranial magnetic stimulation|"Frequency: 1 Hz., Pulse shape: biphasic, Duration: 30 minutes (1800 pulses).
~Neuronavigation: MRI-guided and robot-assisted neuronavigation using Localite software and an Axilum robot."
15938369|NCT03354442|Device|Modified Fixed Mandibular Retractor Appliance|All patients with Class III malocclusion will be treated using the Modified Fixed Mandibular Retractor Appliance
15938370|NCT03354429|Drug|Ticagrelor|Ticagrelor arm: Day 1, loading dose of ticagrelor followed by daily maintenance dose until Day 30.
15938371|NCT03354429|Drug|Placebo|Placebo arm: Day 1, loading dose of placebo followed by placebo daily maintenance dose until Day 30.
15938372|NCT03354390|Biological|cell infusion|This is a single-arm, phase 1 trial of HERV-E TCR transduced CD8+/CD34+ T cells in HLA-A*11:01 positive patients with metastatic ccRCC. The study is planned based on a Phase 1 3+3 dose escalation design. The maximum tolerated dose (MTD) is defined as the highest dose at which 0 or 1 patient in six has experienced a dose limiting toxicity (DLT). Patients with evaluable advanced/metastatic ccRCC will be recruited in up to 4 dose levels.
15938373|NCT03354377|Behavioral|Dietary Intervention Meetings|Participants will attend classes once per week for the first 6 months, bi-weekly for the next 6 months; then once a month for the last 12 months.
15938374|NCT03354377|Behavioral|Physical Activity|Participants will be given the following exercise recommendations: strength training twice per week and ≥75 min of vigorous or ≥150 min of moderate PA per week and will be provided with accelerometers.
15938375|NCT03354377|Behavioral|Podcasts/Mailings|Participants with receive additional support delivered remotely months 13-24 in the form of audio podcasts and email newsletters.
15938376|NCT03354364|Dietary Supplement|Pea hull fiber|Snacks containing 15 g/day of ground pea hulls.
15938377|NCT03354364|Dietary Supplement|Control|Snacks without added fiber.
15938378|NCT03354351|Behavioral|Stepped-care model|The intervention proposed in this study is a stepped-care model (comprising 3 steps) integrating cognitive-behavioural therapy or trauma-focused therapy and emotion-focused therapy that involves matching individuals to the most appropriate level of care, based on their specific needs . When patients do not show improvement they move to higher, more intensive levels of care.
15938379|NCT03354338|Drug|Amoxicillin|Intensive Periodontal treatment; Pre-medication with 2 gr of oral Amoxicillin 1 hour before treatment
15938380|NCT03354338|Other|Placebo|Intensive Periodontal treatment; Pre-medication with 2 gr of Placebo 1 hour before treatment
15938381|NCT03354325|Behavioral|Scheduled PCP follow-up|Parents of children randomized to scheduled follow up will be instructed to follow up with their primary care physician within 4 days of discharge regardless of improvement and/or symptom resolution. Research coordinators will verify that the child has a scheduled follow up appointment prior to discharge.
15938382|NCT03354325|Behavioral|As needed PCP follow-up|At the time of hospital discharge, parents will be instructed that the child does not need to automatically follow up with his/her primary care physician. Rather, the child should follow up on an as needed basis: if the child does not improve or if new concerns arise.
15938383|NCT03354312|Drug|Lidocaine Hydrochloride 1% Gel|Cylinder vials with 1.7 g gel containing 34 mg lidocaine (1 g gel contains 20 mg lidocaine) will be used. Application of the gel into the periodontal pockets or the sulcus according to summary of product characteristics (SmPC). A total dose of 40 mg lidocaine should not be exceeded.
15938384|NCT03354312|Drug|Articaine hydrochloride/epinephrine (adrenaline) hydrochloride|Cylinder vials with 1.7 ml solution for injection containing 68 mg articaine and 0.0102 mg epinephrine (1 ml contains 40 mg articaine and 0.006 mg epinephrine) will be used. Infiltration anesthesia for the upper jaw and infiltration or nerve block anesthesia for the lower jaw with articaine solution for injection according to SmPC. Adults can be treated with up to 7 mg articaine per kg of body weight per treatment session.
15938385|NCT03354299|Dietary Supplement|coconut milk|50 cc of coconut milk supplementation plus 25 gram sugar (pudding) was given to cirrhosis patients as late night snack
15938386|NCT03354286|Behavioral|Developmental & Technological Demands|Education and training related to use of CGM in this age group
15938387|NCT03354286|Behavioral|Distress Reduction|Education and training on reducing distress
15938388|NCT03354286|Behavioral|Nutrition, Set Point, & C:I Ratio|Education and training on how to use the HCL system to dose for different kinds of foods to improve glycemic control
15938389|NCT03354286|Behavioral|Hypoglycemia management|Education and training on reducing worries of hypoglycemia
15938390|NCT03354286|Behavioral|Minimal Intervention|Minimal intervention to simulate standard care - serves as the control group
15938391|NCT03354273|Drug|PET MPI|Flurpiridaz (18F) Injection. All subjects will receive 2 IV boluses of Flurpiridaz (18F) Injection in a large peripheral vein: 1 at rest and 1 during stress. The dosages of Flurpiridaz (18F) Injection administered at rest and during stress conditions will not exceed a total of 14 mCi (520 MBq) for an individual subject.
15938392|NCT03354273|Drug|SPECT MPI|SPECT imaging must use 99mTc-based myocardial tracers. SPECT agents utilised for the purposes of this clinical study will be administered as per American Society of Nuclear Cardiology or European Association of Cardiovascular Imaging standards, where applicable. All patients will undergo SPECT MPI.
15938393|NCT03354273|Drug|Pharmacological stress agents|Pharmacologic stress agents will be restricted to the following 3 agents, as permitted by local marketing authorisations and availability: adenosine, dipyridamole, and regadenoson. Administration will be through an IV line.
15938394|NCT03354260|Other|Personalized adapted oral diet and nutritional education|Optimized personalized oral nutrition in ICU and nutritional follow up with therapeutic educational after exit of ICU
15938395|NCT03354247|Behavioral|Lifestyle Intervention|Participants randomized to the Lifestyle Intervention will receive an intensive, state-of-the-art weight loss intervention based on a Mediterranean diet and physical activity. The intervention will focus on changing both eating and exercise habits with a goal of producing a 7-10% weight loss within the first 6 months and then maintaining this weight loss. Participants will be evaluate using validated questionnaires and adherence scores to assess food intake and physical activity, and will then be closely followed during the intervention period.
15938396|NCT03354234|Other|Head up tilt (HUT)|Model of -Gz: HUT up to 75 degrees (maximum)
15938397|NCT03354234|Other|Lower body negative pressure (LBNP)|Model of -Gz: LBNP down to -100 mmHg (maximum)
15938398|NCT03354234|Other|Head down tilt (HDT)|Model of +Gz: HDT down to -30 degrees (maximum)
15938399|NCT03354234|Device|Tilt table|Range of tilt angles: -45° to +80°, rate of tilt changes: up to 45°/s
15938400|NCT03354234|Device|LBNP chamber|Range of generated underpressure: 0 to -100 mmHg, rate of underpressure changes: up to 20 mmHg/s
15938401|NCT03354221|Device|Cytosponge|Patients undergoing the six food elimination diet will be monitored during the initial elimination period at 2, 4 and 6 weeks with swallowing the cytosponge. This is a ten minute procedure in the office. The cytosponge will be sent to the lab for histology reading of the eosinophilic count.
15938402|NCT03354221|Other|Diet|During the initial 6 week elimination period, participants will eliminate the 6 most common food allergens from their diet (fish, nuts, eggs, soy, wheat, dairy). Participants will return for the cytosponge during this time at 2, 4 and 6 weeks of elimination.
15938403|NCT03354221|Other|EEsAI Pro|This is a short questionnaire to assess the participants swallowing. This will be completed at baseline and during each cytosponge visit during the initial elimination period (2, 4, 6 weeks).
15938404|NCT03354221|Other|Likert Scoring Scale|"This is a short questionnaire for patients to compare their experiences swallowing the cytosponge versus completing an upper endoscopy. The scale is rated from worst experience to best experience."
15938405|NCT03354208|Other|blood sampling|small volume blood sampling, according to local laws, is not categorized as intervention (observational study)
15938406|NCT03354195|Procedure|Unicompartmental knee arthroplasty with the Mako Robotic Arm-assisted system.|All patients will receive the RESTORIS MCK (Multicompartmental Knee) Implant System, which is approved for use in unicompartmental knee arthroplasty with the Mako Robotic Arm-assisted system. The femoral component is constructed from cobalt chrome (CoCr) and the tibial component is constructed from an ultra-high molecular weight polyethylene (UHMWPE) insert and titanium (Ti) baseplate. UKA will be facilitated with MAKO Robotic-Arm Assisted Surgery, which has been shown in prior studies to lower pain and result in more accurate implant placement than manual UKA in a randomized controlled trial.(15)
15938407|NCT03354182|Procedure|Open flap surgery|Elevation of a flap in order to access the treated furcation
15938408|NCT03354182|Device|Bio-oss collagen|Biomaterial for periodontal surgery
15938409|NCT03354182|Device|Bio-gide|Biomaterial for periodontal surgery
15938410|NCT03354169|Behavioral|Eating Condition|Participants will be randomly assigned to eat per the prescribed eating condition for 8 weeks during eating condition 1. They will complete the alternate eating condition for 8 weeks during eating condition 2.
15938411|NCT03354156|Drug|statin treatment|The patients with elevated LDL receive statin treatment in the context of normal patient care (so this is NOT an intervention of the study)
15938412|NCT03354143|Drug|Standard Care|Calcium channel blocker (CCB, amlodipine), angiotensin II receptor blocker (ARB, losartan), and other antihypertensive drugs will be used to reduce 24-hour SBP ≤ 130 mmHg.
15938413|NCT03354143|Drug|Intensive Treatment|Calcium channel blocker (CCB, amlodipine), angiotensin II receptor blocker (ARB, losartan), and other antihypertensive drugs will be used to reduce 24-hour SBP ≤ 120 mmHg.
15938414|NCT03354130|Other|Processed meat dietary intervention|Randomized cross-over dietary intervention with 5 different diets
15938415|NCT03354117|Drug|Ulipristal Acetate 30 MG Oral Tablet|Each study participant will receive one dose of the study medication (ulipristal acetate 30mg plus meloxicam 15mg) at peak fertility in the treatment cycle.
15938416|NCT03354104|Device|The tunnel technique for root coverage with Emdogain|The tunnel technique for root coverage with Emdogain
15938417|NCT03354104|Device|The tunnel technique for root coverage without Emdogain|The tunnel technique for root coverage without Emdogain
15938418|NCT03354091|Device|FitBit Flex 2|Participants in the intervention Group will wear the FitBit Flex 2 for Three months.
15938419|NCT03354078|Procedure|interrupted sutures|The way of closing subcutaneous tissue either by interrupted
15938420|NCT03354078|Procedure|continous sutures|The way of closure of subcutanous tissue is by continous sutures
15938421|NCT03354065|Dietary Supplement|TIME OF FEEDING|Liquid ( Re Feeding 8 h ) OR Enteral Feeding ( re feeding 48 h)
15938422|NCT03354052|Device|Real-rTMS + Gloreha device|The real rTMS will be delivered using a 8-shaped coil placed over the primary motor cortex (M1). The resting motor threshold (RMT) will be assessed at the place of the first dorsal interosseous (FDI) contralateral to the stimulated cortex. RMT of the FDI will be determined as the lowest strength of TMS needed to elicit 5 or more electromyographic responses ≥50 μV within 10 trials. Stimulation will be applied with frequency 10 Hz and intensity of 90% of RMT. Every session will last 15 minutes and includes 3000 pulses (30 trains of 10 seconds, following intertrain interval of 20 seconds). Rehabilitation programme will last 30 minutes and will be delivered using Gloreha® device, a proprioceptive stimulator under visual feedback. All the subjects enrolled will receive treatments for 2 weeks, 5 days per week.
15938423|NCT03354052|Device|Sham-rTMS + Gloreha device|The sham rTMS will be delivered using a sham stimulator. All procedures will be performed as for the real treatment. Rehabilitation programme will last 30 minutes and will be delivered using Gloreha® device, a proprioceptive stimulator under visual feedback. All the subjects enrolled will receive treatments for 2 weeks, 5 days per week.
15938424|NCT03354039|Drug|Tamoxifen|DMD patients randomised to verum will receive 20 mg (0.6mg/kg) of Tamoxifen daily. Treatment will be given for the total period of 48 weeks.
15938425|NCT03354039|Drug|Matching placebo|Patients randomised to placebo will be administered matching placebo. Treatment will be given for the total period of 48 weeks.
15938426|NCT03354026|Drug|AICH-PXZY|8herbals (with 2 herbals of Activating blood stagnation and expelling blood stasis herbs) one dose, bid, for 10 days
15976544|NCT03063034|Other|PD21864AA|A king size menthol cigarette.
15938428|NCT03354026|Drug|AICH-placebo|The placebo is made up of Starch, bitter taste and cyclodextrin
15938429|NCT03354013|Procedure|AOA|100% ICSI-AOA will be performed in the group with less than 6 mature oocytes; 50% ICSI/50% ICSI-AOA will be performed when 6 or more mature oocytes are retrieved
15938430|NCT03354013|Diagnostic Test|Genetic screening|Patients will donate a saliva sample. Genetic screening will take place for PLCzeta (male) and Dux4 (male and female). Also other possible genes involved in embryo development could be tested.
15938431|NCT03354013|Diagnostic Test|Calcium pattern analysis|Male patients will donate a sperm sample. Calcium pattern analysis will take place by injecting the patients' sperm into mouse and/or human (in vitro matured) oocytes (research-donated control oocytes). This will estimate the sperm capability to induce calcium oscillations in the oocyte.
15938432|NCT03354000|Behavioral|Take-home online training|We randomized patients to receive a link to access the online tutorial on their own. Participants in the take-home arm were given a paper handout with a link to the training materials and an outline of the steps for accessing the training curriculum.
15938433|NCT03354000|Behavioral|In-person online training|For participants randomized to the in-person training arm, a trained research assistant prompted participants to log into the learning platform and guided them in accessing the training materials for portal features that were of interest to them. The staff member provided further explanation or clarification if participants had questions about the training material.
15938434|NCT03353987|Behavioral|Cognitive training|"Procedure
~A therapist will go through the daily routine of the participants at home before starting the intervention
~Selections of exercise items based on familiar items/ activities at home
~Given a memory logbook with list of household items, names and numbers and newspaper cuttings from the previous week
~Taught on how to perform the exercises
~Perform at least one hour per day
~Both spatial and visual memory strategies will be used for memory training: simple mnemonics, associations, visualisations, rhymes
~Advised to follow-up with the therapist to review on the progress and compliance of exercises weekly
~The difficulty of the exercise will be adjusted weekly
~List of exercises:
~Memorizing a set of lists, household items, names and numbers
~Summarising the contents of newspaper cuttings within a set of time
~Searching and listing sets of words from newspaper cuttings"
15938435|NCT03353974|Device|Video game therapy|Video game therapy will be delivered with a commercial video game console (X-Box 360 Kinect, Microsoft, Inc., Redmond, WA).
15938436|NCT03353974|Device|Balance platform therapy|Balance/rebalancing, postural stability and weight-shifting exercises with and without visual feedback will be administered using a balance platform (Biodex Medical Systems, Inc., Shirley, NY).
15938437|NCT03353961|Behavioral|Emotion regulation individual therapy|The emotion regulation individual therapy is delivered via an internet platform and includes therapist contact several times per week via the platform.
15938438|NCT03353961|Behavioral|Treatment as usual|Treatment as usual as provided in the community.
15938439|NCT03353948|Drug|MET|In the MET group metformin was initiated at a dose of 500 mg once per day and increased by 500 mg every 3 days up to 1000 mg BID per os for 12 weeks. After 1 month IVF was done.
15938440|NCT03353948|Drug|COMBI|In the COMBI group the initial dose of MET was 500 mg for at least 2 wk and gradually increased to a final dose of 1000 mg BID. Liraglutide 1.2 mg QD s.c. was added after first two weeks of monotherapy with MET. After 1 month IVF was done.
15938441|NCT03353935|Other|Validated questionnaires|Patients were administered pre- and post-operatively the three validated questionnaires ((FSFI, ICIQ-UI short form Italian, NBD score) investigating sexual, urinary, and fecal function, respectively.
15938442|NCT03353922|Drug|Cyclobenzaprine 10 Mg Oral Tablet|cyclobenzaprine 10 mg tablets
15938443|NCT03353922|Drug|Placebo Oral Tablet|sugar pill
15938444|NCT03353909|Device|new crosslinked hyaluronan gel|At the end of the dilatation and curettage, new crosslinked hyaluronan gel was applied to the uterine cavity.
15938445|NCT03353896|Device|Wear novoTTF-200A|Wear novoTTF-200A device
15938446|NCT03353896|Procedure|Quality-of-Life Assessment|Ancillary studies
15938447|NCT03353883|Drug|Triptorelin SR|GnRH agonist depot( Decapeptyl) will be taken in the previous mid luteal cycle in group A and the first day in group B
15938448|NCT03353870|Other|qualitative interview|individual qualitative interview
15938449|NCT03353857|Drug|levonorgestrel/ Microlut|In Period 1, 0.03 mg single dose administered as 1x0.03 mg tablet on Study Day 1, In Period 2, 0.03 mg single dose administered as 1x0.03 mg tablet on Study Day 15 In Period 3, 0.03 mg single dose administered as 1x0.03 mg tablet at Study Day 26
15938450|NCT03353857|Drug|Norethindrone/ Noriday|In Period 1, 0.35 mg single dose administered as 1x0.35 mg tablet on Study Day 1, In Period 2, 0.35 mg single dose administered as 1x0.35 mg tablet on Study Day 15 In Period 3, 0.35 mg single dose administered as 1x0.35 mg tablet at Study Day 26
15938451|NCT03353857|Drug|Desogestrel/ Cerazette|In Period 1, 0.075 mg single dose administered as 1x0.075 mg tablet on Study Day 1, In Period 2, 0.075 mg single dose administered as 1x0.075 mg tablet on Study Day 15 In Period 3, 0.075 mg single dose administered as 1x0.075 mg tablet at Study Day 26
15938452|NCT03353857|Drug|Dienogest/ Visanne|In Period 1, 2 mg single dose administered as 1x2 mg tablet on Study Day 1, In Period 2, 2 mg single dose administered as 1x2 mg tablet on Study Day 15 In Period 3, 2 mg single dose administered as 1x2 mg tablet at Study Day 26
15938453|NCT03353857|Drug|Drospirenone, Ethinylestradiol/ Yasmin|In Period 1, 3 mg drospirenone, 0.03 mg ethinylestradiol single dose administered as 1x3mg drospirenone, 0.03 mg ethinylestradiol tablet on Study Day 1, In Period 2, 3 mg drospirenone, 0.03 mg ethinylestradiol single dose administered as 1x3mg drospirenone, 0.03 mg ethinylestradiol tablet on Study Day 15, In Period 3, 3 mg drospirenone, 0.03 mg ethinylestradiol single dose administered as 1x3mg drospirenone, 0.03 mg ethinylestradiol tablet on Study Day 26,
15938454|NCT03353857|Drug|Midazolam/ Midazolam-ratiopharm|In Period 1, 1 mg single dose administered as 1x0.5 ml oral solution on Study Day 1, In Period 2, 1 mg single dose administered as 1x0.5 ml oral solution on Study Day 15 In Period 3, 1 mg single dose administered as 1x0.5 ml oral solution at Study Day 26
15938455|NCT03353857|Drug|Rifampicin|In period 2, 10 mg (suspension, 0.5 ml) for 11 days at 10 mg/day In period 3, 600 mg (film-coated tablets) for 11 days at 600 mg/day
15938456|NCT03353844|Behavioral|Intradialytic exercise|intradialytic exercise which start and finish in first hour of hemodiafiltration session
15938457|NCT03353831|Drug|Bevacizumab|Bevacizumab will be administered by intravenouse route at a dose of 10mg/kg q14 during the treatment period
15938458|NCT03353831|Drug|Atezolizumab|Atezolizumab will be administered by intravenous route at a dose of 840 mg q14 during the treatment period
15938459|NCT03353831|Drug|Chemotherapy|Chemotherapy (Paclitaxel or PLD) will be administered by intravenous route at different doses during the treatment period q28
15938460|NCT03353831|Drug|Placebos|Placebo will be administered by intravenous route q14 during the treatment period
15938461|NCT03353818|Behavioral|Golf|A free golf course and free membership for one year in a golf club will be given to participants.
15938462|NCT03353818|Behavioral|No intervention|Patients acting as controls will not be restricted in any ways.
15938463|NCT03353805|Behavioral|questionnaire|questionnaire
15938464|NCT03353792|Device|CL/AP system|CL/AP system enabled insulin pump/CGM combination
15938465|NCT03353792|Device|usual diabetic care|usual diabetic care (insulin pump therapy) along with CGM recording
15938466|NCT03353766|Device|Early crossbite correction with Q-H Device|Crossbite treatment in deciduous dentition with Quad-Helix appliance
15938467|NCT03353753|Drug|DCC-2618|Oral KIT/PDGFRA kinase inhibitor
15938468|NCT03353753|Drug|Placebo Oral Tablet|Placebo
15938470|NCT03353727|Other|Orthoptic rehabilitation|Orthoptic rehabilitation using innovative mechanisms (eye tracker and tactile device) for low vision people
15938471|NCT03353714|Other|Pudendal block|Pudendal block with normal saline (for control group) and bupivacaine (for intervention group)
15938472|NCT03353701|Behavioral|Contingency Management (CM)|A reinforcement delivery method that involves financial incentive to participants for sustained alcohol abstinence. CM will start after the participants complete the baseline measures and last for at least 30 days and up to 90 days.
15938473|NCT03353688|Device|Boston Scientific Vercise PC IPG with directional DBS lead|Deep brain stimulation
15938474|NCT03353675|Biological|TG4010|1 dose (1x1E+08) Subcutaneous injection/week over 6 weeks then 1 dose/3 weeks
15938475|NCT03353675|Drug|Chemotherapy|"Pemetrexed/Cisplatin or Carboplatin
~Pemetrexed maintenance"
15938476|NCT03353675|Drug|Nivolumab|360 mg IV administration every 3 weeks
15938477|NCT03353662|Other|Women of Gamo Gofa|The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the women of Gamo Gofa between 15-49 years by measuring hemoglobin (Hb), plasma ferritin (PF), soluble transferrin receptor (sTfR), C-reactive protocol (CRP), alpha-1-acid glycoprotein (AGP), plasma Zn (PZn), plasma retinol and retinol binding protein (RBP), respectively.
15938478|NCT03353662|Other|Children of Gamo Gofa|The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the children of Gamo Gofa between 6-59 months by measuring hemoglobin (Hb), plasma ferritin (PF), soluble transferrin receptor (sTfR), C-reactive protocol (CRP), alpha-1-acid glycoprotein (AGP), plasma Zn (PZn), plasma retinol and retinol binding protein (RBP), respectively.
15938479|NCT03353662|Other|Women of West Gojjam|The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the women of West Gojjam between 15-49 years by measuring hemoglobin (Hb), plasma ferritin (PF), soluble transferrin receptor (sTfR), C-reactive protocol (CRP), alpha-1-acid glycoprotein (AGP), plasma Zn (PZn), plasma retinol and retinol binding protein (RBP), respectively.
15938480|NCT03353662|Other|Children of West Gojjam|The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the children of West Gojjam between the age of 6-59 months by measuring hemoglobin (Hb), plasma ferritin (PF), soluble transferrin receptor (sTfR), C-reactive protocol (CRP), alpha-1-acid glycoprotein (AGP), plasma Zn (PZn), plasma retinol and retinol binding protein (RBP), respectively.
15938481|NCT03353662|Other|Women of Kamashi|The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the women of Kamashi between 15-49 years by measuring hemoglobin (Hb), plasma ferritin (PF), soluble transferrin receptor (sTfR), C-reactive protocol (CRP), alpha-1-acid glycoprotein (AGP), plasma Zn (PZn), plasma retinol and retinol binding protein (RBP), respectively.
15938482|NCT03353662|Other|Children of Kamashi|The prevalence of Fe, Zn and vitamin A deficiency will be assessed in the children of Kamashi between 6-59 months by measuring hemoglobin (Hb), plasma ferritin (PF), soluble transferrin receptor (sTfR), C-reactive protocol (CRP), alpha-1-acid glycoprotein (AGP), plasma Zn (PZn), plasma retinol and retinol binding protein (RBP), respectively.
15938483|NCT03353649|Behavioral|Now vs. Later Cue|"As we collect data from all participants, we will include manipulations (or motivating operations) meant to modulate putative targets within the self-regulation domain in each clinical group - to assess the extent to which we can shift self-regulatory function both in desired and undesired directions. More specifically, subjects will see a now cue instructing them to think of immediately using/consuming that stimulus or a later cue instruction them to think about the long-term consequences of using/consuming that stimulus. The latter cue is intended to down-regulate desire to use/consume the stimulus, and this down-regulation is measured by a subsequent probe asking subjects the degree to which they want to use/consume that stimulus."
15938484|NCT03353649|Device|fMRI|Subjects will complete the tasks inside a functional magnetic resonance imaging device, allowing us to measure brain activity that while completing each task.
15938485|NCT03353636|Dietary Supplement|Magnesium|150mg elemental magnesium
15938486|NCT03353636|Dietary Supplement|Placebo|Rice flour
15938487|NCT03353623|Device|Serious Game|"Serious Game (SG) refers to the use of immersive virtual environments and wearable haptic devices during the treatment. Two SG were specifically developed to allow a playful training of different, targeted Upper Limb (UL) movement based on typical rehabilitation exercises (reach-to-grasp, linear path tracking, hand orientation). The child interacts directly with a virtual environment through haptic feedback provided to his/her fingertips. In particular, moneybox game focused on pincer grasp and reaching tasks with pronation/supination od the hand while marble labyrinth game focused on pointing and tracking movements requiring both eye-hand and upper limb inter-joint coordination."
15938513|NCT03353363|Drug|Bupivacaine|After patients receive their spinal anesthetic and as the Pfannenstiel incision is being closed, an equal volume (20ml, administered via two 10ml syringes) of bupivacaine 0.5% plain will be infiltrated into the wound by the obstetrician team in a standardized fashion.
15938577|NCT03352765|Drug|bendamustine|bendamustine 160 mg/m2 intravenously on days -3 and -2
15938831|NCT03350620|Drug|NVK-002 Concentration 2|Study medication will be administered, once daily (QD)
15938488|NCT03353623|Other|Conventional Therapy|Conventional therapy (CONV) refers to the neurocognitive rehabilitation approach, with the purpose of improving pointing, tracking, reaching and grasping, and pronation/supination of the forearm. The therapeutic sessions were performed with the exception of the visual channel to ensure that the child focused his/her attention on tactile/kinesthetic information to complete the task. In particular, five different tasks have been proposed during the sessions: 1) recognize trajectories; 2) arm proprioception; 3) object manipulation; 4) recognize surfaces; 5) forearm orientation.
15938489|NCT03353597|Biological|Plasma Transfusion|All subjects will receive monthly, 2-unit transfusions of young healthy male donor plasma for total of 6 treatments. The plasma will be administered at a transfusion services facility in a manner consistent with generally accepted and standard guidelines for plasma transfusions.
15938490|NCT03353584|Other|Virtual Reality Therapy|The VR intervention consists of an interactive audio and visual underwater experience designed to serve as a calming distraction activity. The VR software (Kind VR® Aqua) was developed by KindVR specifically for the purpose of pain distraction in a hospital setting.
15938491|NCT03353571|Device|"C3 UMBRELLA CATHETER"|The C3 is an alternative method to facilitate bladder drainage in the study population which are using either a foley catheter or Clean Intermittent Catheter technique to drain the bladder.
15938492|NCT03353558|Device|Actigraph|The watch will measure sleep parameters like quality of sleep, time to fall asleep, number of awakenings during night, length of deep sleep.
15938493|NCT03353519|Other|Primary care model|"Specifically, the intervention will comprise the following components:
~Structured review of patient needs;
~A self-management programme (MLAS) for stroke survivors and their carers;
~A direct point of contact for stroke survivors and carers at the GP surgery;
~Optimised communication between General Practice staff and specialist services;
~Service mapping for stroke related needs;
~Training for General Practice staff."
15938494|NCT03353506|Biological|LFMT|Lyophilized fecal microbiota transplant
15938495|NCT03353506|Biological|LSFF|Lyophilized sterile fecal filtrate
15938496|NCT03353493|Behavioral|MBCT|Mindfulness-Based Cognitive Therapy (MBCT) is an 8 week manualised group intervention. MBCT will be delivered according to the manual by Segal, Williams & Teasdale (2013).
15938497|NCT03353493|Other|TAU|Treatment as usual (TAU)
15938498|NCT03353480|Drug|Azithromycin Tablet manufactured in China|250 mg Azithromycin Tablet manufactured in China
15938499|NCT03353480|Drug|Azithromycin Tablet manufactured in US|250 mg Azithromycin Tablet manufactured in US
15938500|NCT03353467|Procedure|Endoscopic surgery|Endoscopic nasopharyngectomy included endoscopic resection, with or without posterior pedicle nasal mucoperiosteal flap resurfacing the nasopharyngeal defects.
15938501|NCT03353467|Radiation|Intensity-modulated radiotherapy|All of the patients were received irradiation by IMRT. The target volumes were delineated according to a previously described institutional treatment protocol, which is in accordance with the International Commission on Radiation Units and Measurements reports 50 and 62.
15938502|NCT03353454|Drug|Maralixibat|Maralixibat oral solution (up to 600 mcg/kg) orally twice daily for 26 weeks.
15938503|NCT03353454|Drug|Placebo|Placebo matching to maralixibat orally twice daily for 26 weeks.
15938504|NCT03353441|Dietary Supplement|Microencapsulated Sublingual Glycine (MSG)|Glycine (MSG) tablet
15938505|NCT03353441|Dietary Supplement|Placebo|Lactose tablet manufactured to mimic Glycine (MSG) tablet
15938506|NCT03353428|Biological|LC-CTLs|2 to 4 infusions, once a week, for 1x10^5~4x10^6 CTLs/kg via IV, chest or tumor injection each time
15938507|NCT03353415|Device|Dexcom continuous glucose monitor|The CGM will monitor sensor glucose levels in all participants. During the first two weeks of the study, participants will be masked to the sensor glucose levels and will need to use other methods, such as a blood sample from a finger stick, to check their blood sugar. During the second two weeks, participants will be able to see the sensor glucose levels displayed from the CGM. Participants will be instructed to use this information to treat low glucose levels before symptoms or severely low glucose levels develop.
15938508|NCT03353402|Procedure|Fecal Microbiota Transplant (FMT)|Patients with metastatic melanoma who responded to immunotherapy will serve as the fecal implant donors. The tested fecal implant will be used for two different products. The first part of the tested stool will be mixed with a saline solution, strained and infused into your bowel using colonoscopy. The second part of the tested stool will be packed into capsules. These stool capsules are at the size of standard drug-containing capsules and can be swallowed in a standard manner. Stool capsules are a common method of FMT and has been used worldwide for several years. After the colonoscopy, you will be asked to swallow the capsules. Swallowing the capsules will be conducted at the clinic, and does not require any additional procedures.
15938509|NCT03353389|Other|No AKI|Subjects will be allocated into this group if they did not acquire Acute Kidney Injury during admission.
15938510|NCT03353389|Other|CA-AKI|"CA-AKI is defined by any patient who developed AKI (as per definition below) within 48 hours of hospital admission.
~Definition of AKI:
~i. An increase in serum creatinine of 0.3 mg/dl (26.5 μmol/l) within 48 hours OR ii. An increase in serum creatinine to more or equal to 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days
~Definition for baseline creatinine:
~i. The baseline creatinine level is defined as the creatinine level at or within 7 days before the hospital admission, OR ii. at the hospital admission OR iii. the lowest creatinine (excluding the post dialysis creatinine if dialysis is initiated) during the index hospitalisation for those whose baseline creatinine were unknown."
15938511|NCT03353389|Other|HA-AKI|"HA-AKI is defined by any patient who developed AKI (as per definition below) after 48 hours of hospital admission.
~Definition of AKI:
~i. An increase in serum creatinine of 0.3 mg/dl (26.5 μmol/l) within 48 hours OR ii. An increase in serum creatinine to more or equal to 1.5 times baseline, which is known or presumed to have occurred within the prior 7 days
~Definition for baseline creatinine:
~i. The baseline creatinine level is defined as the creatinine level at or within 7 days before the hospital admission, OR ii. at the hospital admission OR iii. the lowest creatinine (excluding the post dialysis creatinine if dialysis is initiated) during the index hospitalisation for those whose baseline creatinine were unknown."
15938512|NCT03353376|Behavioral|group care with Empowerment model|Patients with type 2 and type 1 diabetes were followed in a tertiary outpatient clinic with group appointment
15938549|NCT03353012|Drug|Levonorgestrel Drug Implant|Levonorgestrel 75 mg (2 rods) are implanted at inner arm of participant.
15938832|NCT03350620|Drug|Placebo|Vehicle (placebo) will be administered, once daily (QD)
15938514|NCT03353363|Drug|Liposomal bupivacaine|After patients receive their spinal anesthetic and as the Pfannenstiel incision is being closed, an equal volume (20ml, administered via two 10ml syringes) of one liposomal bupivacaine will be infiltrated into the wound by the obstetrician team in a standardized fashion.
15938515|NCT03353363|Drug|Placebos|After patients receive their spinal anesthetic and as the Pfannenstiel incision is being closed, an equal volume (20ml, administered via two 10ml syringes) of normal saline will be infiltrated into the wound by the obstetrician team in a standardized fashion.
15938516|NCT03353350|Drug|efpeglenatide (SAR439977)|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous"
15938517|NCT03353350|Drug|placebo|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous"
15938518|NCT03353337|Behavioral|aerobic exercise|Cycling at the intensity of 50%-70% of maximum heart rate (220-age) for 30 mins per day, 4 days per week, last for 1 months.
15938519|NCT03353337|Behavioral|Placebo controlled group|General intensity activities of recreation therapy, including Handicraft manufacture, reading activity, singing entertainment, walking.
15938520|NCT03353324|Drug|intravitreal injection of bevacizumab|under gone 3 intravitreal injection of bevacizumab monthly and examine monthly for Visual acuity and central macular thickness, if in month four or more the CMT is more than 250 micrometer and the visual acuity is less than 8/10 the injection is repeatet and follow up in this manner is continued until 9 months.
15938521|NCT03353324|Radiation|intravitreal injection of bevacizumab+ targeted laser|"patients in this group undergone laser photocoagulation of retinal non perfused areas based on FAG wide field imaging .
~After 9 month follow up the outcomes such as Vusal acuity, Central macular thickness, intraocular pressure, neovascular formation are compared"
15938522|NCT03353298|Drug|Allopurinol 300 mg|Allopurinol oral tablets 300 mg given to participants once daily for 9 months
15938523|NCT03353298|Drug|Placebo Oral Tablet|placebo oral tablets given to participants once daily for 9 months
15938524|NCT03353285|Procedure|intracytoplasmic sperm injection (ICSI)|All eggs will be fertilized by ICSI
15938525|NCT03353272|Behavioral|Patient Engagement Education and Restructuring of Cognitions|This protocol, informed by principles of CBT, involves three components: 1) engagement, 2) education and 3) cognitive restructuring and behavioral activation. A health coach who is responsible for engaging patients, educating them about pain modulatory mechanisms, and reinforcing cognitive and behavioral coping skills, will deliver the PEERC protocol.
15938526|NCT03353259|Combination Product|Tranexamic acid and Tocilizumab|The first intervention is Tranexamic acid, The second intervention is Tocilizumab
15938527|NCT03353246|Device|InfraScanner 2000™|The Infrascanner is a portable screening device that uses Near-Infrared (NIR) technology to screen patients for intracranial bleeding, identifying those who would most benefit from immediate referral to a CT scan and neurosurgical intervention.
15938528|NCT03353233|Drug|Ropivacaine|Local anesthetic (numbing drug)
15938529|NCT03353233|Procedure|Interspace Between the Popliteal Artery and Capsule of the Knee (iPACK) Block|An ultrasound guided nerve block using a numbing medication called ropivacaine that numbs the nerves to the back of the knee.
15938530|NCT03353233|Drug|Saline|An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.
15938531|NCT03353220|Drug|Belviq|Belviq is an oral drug
15938532|NCT03353220|Drug|Placebo|The placebo is made to mimic Belviq, but does not contain any active drug
15938533|NCT03353181|Device|Endoscopic scissors|Application of endoscopic cutting technique following endoscopic nasobiliary drainage in the treatment of malignant hilar biliary strictures.
15938534|NCT03353181|Device|Biliary stent|Standard placement of biliary stent
15938535|NCT03353155|Behavioral|Usual Care|
15938536|NCT03353155|Behavioral|CareHub|
15938537|NCT03353142|Other|Equal Breathing|"Blood pressure recorded at baseline, immediately pre- and post-trial
~Maximum Tolerable Breathing Ratio: Test run to determine the maximum tolerable time for inhalation and exhalation.
~PRESSURE TOLERANCE: Pressure algometer device used to determine pain pressure tolerance. It will be applied to the first dorsal interosseous and deltoid, and pain pressure tolerance will be measured and recorded. Pressure will be applied at 1kg per second until the patient indicates that the pressure has become painful. Pain pressure tolerance will be performed 3 times at each anatomical location and an average will be determined for each location.
~TRIAL: Participants will begin 5 minutes of Equal Breathing at their maximum tolerable equal breathing ratio that was previously determined. Immediately after 5 minutes of breathing, the pain pressure tolerance will be measured using pressure algometry"
15938538|NCT03353116|Procedure|the mandible first|the mandible osteotomy is going to be done and fixed first
15938539|NCT03353116|Procedure|the maxilla first|the maxilla osteotomy is going to be done and fixed first
15938540|NCT03353103|Drug|Sodium fluoride F-18 PET imaging|prior to surgical endarterectomy each patient will undergo sodium fluoride F-18 PET imaging
15938541|NCT03353077|Device|Radiation: Diffusing Alpha Radiation Emitters Therapy (DaRT)|An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.
15938542|NCT03353064|Other|Vivify|A telemedicine kit will (Vivify) which will obtain daily biometrics (vital signs) and care plans. These are all monitored by the Pulmonary team remotely via an online portal. The telemedicine system has a set-up for alerts whenever there are clinical concerns (vital signs out of parameters), or non-use of the Non-invasive positive pressure ventilation (NIPPV). This system allows for video conferencing between the Pulmonary team (physician, respiratory therapist, nurse) to troubleshoot issues, and increase NIPPV compliance.
15938543|NCT03353064|Other|EMS|Emergency medical service scheduled home visits for face to face troubleshooting of the NIPPV, environmental check and end-tidal CO2.
15938544|NCT03353051|Other|Observational study|Observational study
15938545|NCT03353038|Device|3D printed pillbox|The research team interviewed the participant about their habits, routines, preferences, medications, and skills and abilities. Based on the interview, the research team designed and printed a customized 3D printed pillbox.
15938546|NCT03353025|Procedure|transsphenoidal surgery treatment|transsphenoidal surgery treatment
15938547|NCT03353025|Drug|dopamine agonist treatment|Minimum effective dose of dopamine agonist，bromocriptine，treat prolactinona
15938548|NCT03353012|Drug|Etonogestrel Drug Implant|Etonogestrel 68 mg (single rod) is implanted at inner arm of participant.
15938550|NCT03352999|Procedure|Fast track access to vaECMO|"ROHCA must be witnessed with onset of bystander CPR and an immediate call to Emergency Dispatch. Furthermore, to minimize any loss of time, all qualified geographical locations are directly incorporated in the regulation software of the center for medical emergency control.
~Patients suitable for vaECMO implantation were identified as early as possible by the Medical Dispatcher at the Emergency Call Dispatch Center.
~Bystanders pursued CPR until Mobile Intensive Care Unit (MICU) arrival. OHCA was considered refractory after 10 min of CPR initiating the transport by MICU to the hospital such that the vaECMO intervention could be performed. The resuscitation was pursued during the transfer to hospital. An automated chest compression device was used in order to minimize interruption periods.
~The intensivists and cardiac surgeons stood ready to implant the vaECMO surgically in the catheterization laboratory where a percutaneous coronary intervention was subsequently performed."
15938551|NCT03352986|Biological|biological analysis|biological analysis will be performed in the 6 groups of patients
15938552|NCT03352986|Other|peripheral arterial tonometry|peripheral arterial tonometry will be performed in the 6 groups of patients
15938553|NCT03352973|Other|active tDCS on the dlPFC|During active tDCS session, participants will perform the regulation of craving (ROC) and emotion regulation (ER) tasks. In the ROC task, participants will downregulate and upregulate craving elicited by gaming pictures using cognitive reappraisal. In the ER task, participants will downregulate and upregulate aversive feelings by negative pictures using cognitive reappraisal. After the active tDCS session, participants will complete a cognitive task assessing inhibitory control of attentional bias, in which participants will perform a number classification task with gaming pictures and non-gaming pictures being distractors. During the task, reaction times (RTs) wil be recorded.
15938554|NCT03352973|Other|sham tDCS on the dlPFC|During the sham tDCS session, participants will perform the regulation of craving (ROC) and emotion regulation (ER) tasks. In the ROC task, participants will downregulate and upregulate craving elicited by gaming pictures using cognitive reappraisal. In the ER task, participants will downregulate and upregulate aversive feelings by negative pictures using cognitive reappraisal. After the sham tDCS session, participants will complete a cognitive task assessing inhibitory control of attentional bias, in which participants will perform a number classification task with gaming pictures and non-gaming pictures being distractors. During the task, reaction times (RTs) wil be recorded.
15938555|NCT03352947|Drug|Dabrafenib|150mg Dabrafenib twice daily day 1-21 of 28 day cycle in intermittent arm Day 1-28 of 28 day cycle in continuous arm
15938556|NCT03352947|Drug|Trametinib|Trametinib 2mg once daily Day 1-14 of a 28 day cycle in intermittent arm Day 1-28 of a 28 day cycle in the continuous arm
15938557|NCT03352934|Drug|Avelumab|Avelumab will be administered as intravenous infusion at 10 mg/kg once every two weeks until documented disease progression (PD), unacceptable toxicity, or any criterion for treatment withdrawal are met.
15938558|NCT03352921|Other|clinical pilates exercises|servikal, deep flexor muscles, posture exercsises
15938559|NCT03352921|Other|home exercises program|stretching, strengthening, and posture exercises to reduce functional disability, to relieve the pain and to provide postural straightening.
15938560|NCT03352895|Dietary Supplement|resveratrol|Grape seed extract 100mg Microcrystalline Cellulose 90mg Magnesium Stearate 2mg Gelatin 100mg
15938561|NCT03352895|Dietary Supplement|Placebo|The gel contains a mixture of glucose and maltodextrin - a complex carbohydrate - along with fat and a trace of protein.
15938562|NCT03352882|Diagnostic Test|Ultrasound|Hepatic ultrasound using gray scale, color Doppler, and spectral Doppler imaging to evaluate hepatic vein and portal vein patency, direction and velocity of flow respectively. ARFI will be performed in the right hepatic lobe. Three measurements of stiffness (m/s) will be performed and the mean value recorded.
15938563|NCT03352869|Drug|Exenatide|Use Exenatide for 3 months to treat PCOS
15938564|NCT03352869|Drug|Metformin|Use Metformin for 3 months to treat PCOS
15938565|NCT03352856|Other|Barley starch|Highly purified barley starch
15938566|NCT03352856|Other|Maize starch|Maize starch
15938567|NCT03352843|Drug|Primaquine|All patients will be administered with a single low-dose of primaquine in addition to standard artemether-lumefantrine regimen, and then followed-up for 28 days for clinical and laboratory assessment to assess safety and efficacy.
15938568|NCT03352830|Behavioral|RANAS Behavior Change Intervention|The Risks, Attitudes, Norms, Abilities, and Self-Regulation (RANAS) Model is a health behavior change intervention, which has been successfully used in the area of water, sanitation, and hygiene. It draws from numerous health behavior theories, including the Theory of Planned Behavior, the Health Action Process, and the Health Belief Model. The model posits that the five factor blocks (risks, attitudes, norms, abilities, and self-regulation) that must be aligned toward the new behavior in order to influence change. A series of activities target each block accordingly.
15938569|NCT03352830|Other|Infrastructural Intervention - Direct Delivery|Product demand is influenced, in part, by accessibility. Investigators are testing the degree to which this is true for liquefied petroleum gas (LPG) by establishing a direct delivery system for communities randomized to this treatment arm. Individuals in these communities are able to contact a 'delivery agent', contracted by the Kintampo Health Research Centre, who will: 1) retrieve their cylinder, 2) refill with LPG, and 3) return to the participant. The cost of delivery is free to the participant (paid by the study), but the participant is expected to fully pay for their own LPG.
15938570|NCT03352817|Other|Cardiac rehabilitation|A questionnaire and an information sheet are provided. The questionnaire had to be completed anonymously and individually by the patient, to avoid any influence.
15938571|NCT03352804|Other|Screening of MDR Bacteriae|questionnaire will be filled by every patient
15938572|NCT03352791|Behavioral|DSM-H Hospice Edition performance improvement program|Patients in the performance improvement group will receive care from a care team who has received the DSM-H Hospice Edition performance improvement program
15938573|NCT03352791|Behavioral|Usual Care|control will receive usual care from a care team who has not received the performance improvement program.
15938576|NCT03352765|Drug|rituximab|rituximab 375 mg/m2 on days -11 and -4, The second dose of rituximab (day -4) is administered 7 days after the first dose (day -11), +/- 1 day. Rituximab may be administered by a local oncologist. If the participant has a CD20 negative tumor, rituximab can be omitted from the conditioning regimen.
15938578|NCT03352765|Drug|melphalan|melphalan 140 mg/m2 intravenously on day -1 before the reinfusion of autologous stem cells on day 0.
15938579|NCT03352765|Procedure|Autologous Stem Cell Transplantation (ASCT)|reinfusion of autologous stem cells on day 0.
15938580|NCT03352752|Device|HTC Vive|Wearing VR helmet before operation
15938581|NCT03352752|Other|Without HTC Vive|Wearing a blindfold before operation
15938582|NCT03352739|Device|DBS of the fornix, power on|"DBS of bilateral columns of the fornix is performed, with the power of the device on since the 1st month after the implantation. Observations will start at the time when the device is turning on .
~DBS system includes:
~Pins G102 Implantable Neurostimulator; Pins L301 DBS Electrode； Pins E202 DBS extension lead"
15938583|NCT03352739|Device|DBS of the NbM, power on|"DBS of bilateral NbMs is performed, with the power of the device on since the 1st month after the implantation. Observations will start at the time when the device is turning on .
~DBS system includes:
~Pins G102 Implantable Neurostimulator; Pins L301 DBS Electrode； Pins E202 DBS extension lead"
15938584|NCT03352739|Device|DBS of the fornix, power off|"DBS of bilateral columns of the fornix is performed, the power of the device is going to keep off during the first 7 months after the implantation. Observations will start after 1 month of the implantation.
~DBS system includes:
~Pins G102 Implantable Neurostimulator; Pins L301 DBS Electrode； Pins E202 DBS extension lead"
15938585|NCT03352739|Device|DBS of the NbM, power off|"DBS of bilateral NbMs is performed, the power of the device is going to keep off during the first 7 months after the implantation. Observations will start after 1 month of the implantation.
~DBS system includes:
~Pins G102 Implantable Neurostimulator; Pins L301 DBS Electrode； Pins E202 DBS extension lead"
15938586|NCT03352726|Drug|DBV712 IHRP|DBV712 Solution for Skin Prick Test
15938587|NCT03352713|Behavioral|Laddr|"Laddr is an integrated, personalized, web-based self-regulation assessment and behavior change system. It integrates tools that have been shown to be effective for a wide array of behavioral phenomena ranging from substance use and abuse, mental health, risk-taking, chronic pain management, medication adherence, diet, exercise, diabetes and other chronic disease management, and smoking. The organizational structure, functionality and content within Laddr's system centrally embrace these fundamental aspects of behavior change; thus, the Laddr platform is not diagnosis-specific but rather enables integrated care for any combination of individuals' goals, needs, and preferences."
15938588|NCT03352700|Drug|3L PEG|Group A patients (n = 300) used only 3L PEG before colonoscopy.
15938589|NCT03352700|Drug|3L PEG+Dyclonine Hydrochloride Mucilage|Patients in group B (n = 300) were additionally advised to Dyclonine Hydrochloride Mucilage plus 3 L PEG
15938590|NCT03352687|Procedure|anterior SSAX|block of the suprascapular nerve block for shoulder surgery by anterior way
15938591|NCT03352687|Procedure|posterior SSAX|block of the suprascapular nerve block for shoulder surgery by posterior way
15938592|NCT03352674|Drug|Insulin Glargine Ezelin|Insulin Glargine (Ezelin) once daily at individually adjusted dose
15938593|NCT03352674|Drug|Insulin Glargine Pen Injector [Lantus]|Insulin Glargine (Lantus) once daily at individually adjusted dose
15938594|NCT03352661|Other|Collect retrospectively data|Collect retrospectively data
15938595|NCT03352622|Other|CASES|Patients with RA with methotrexate therapy and inhibitors of tumor necrosis factor alpha (TNFα) infliximab, etanercept, adalimumab; That present problems of effectiveness.
15938596|NCT03352622|Other|CONTROLS|Patients with RA with methotrexate therapy inhibitors of tumor necrosis factor alpha (TNFα) infliximab, etanercept, adalimumab; No problems of effectiveness
15938597|NCT03352609|Device|Active rTMS with MagVenture MagPro double blind rTMS system|5 sessions of rTMS delivered with MagPro (MagVenture) double blind rTMS system delivered at 110% of resting motor threshold with 3000 pulses of 10hz stimulation (5s on, 10s off) per session.
15938598|NCT03352609|Device|Sham rTMS|Double blind MagPro system delivers sham condition by mimicking rTMS sound and delivering skin stimulus via TENS pads
15938599|NCT03352596|Other|low frutose diet|
15938600|NCT03352583|Dietary Supplement|Protein|40g calcium caseinate
15938601|NCT03352570|Device|COLOVAC|The intervention consists in the placement of the Colovac device, during the colorectal surgery, Once the colorectal anastomosis has been completed as per standard care and the water-thightness of the anastomosis has been verified.
15938602|NCT03352557|Drug|BIIB092|Administered as specified in treatment arm.
15938603|NCT03352557|Drug|Placebo|Administered as specified in treatment arm.
15938604|NCT03352544|Behavioral|Exercise|Exercise training for 12 weeks (aerobic and resistance training trice a week)
15938605|NCT03352531|Biological|AK-105|Anti-PD-1 monoclonal antibody; Subjects will receive AK105 by intravenous administration.
15938606|NCT03352518|Device|WM3.4NR|The investigational medical device will collect spectral raman data from tissue.
15938607|NCT03352492|Procedure|Superior laser peripheral iridotomy|Iridotomy placement between 11:00 and 1:00 o'clock
15938608|NCT03352492|Procedure|Temporal laser peripheral iridotomy|Iridotomy placement at 3:00 or 9:00 o'clock
15938609|NCT03352479|Other|Opioid Return|Calculate the percentage of prescribed to returned opioids
15938610|NCT03352466|Biological|NasoShield|NasoShield is an adenovirus-vectored anthrax vaccine.
15938611|NCT03352466|Biological|BioThrax|Commercially available anthrax vaccine
15938612|NCT03352466|Other|Placebo|Normal saline
15938613|NCT03352453|Drug|Rapastinel|Rapastinel pre-filled syringes for weekly IV injections.
15938614|NCT03352453|Drug|Placebo|Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
15938615|NCT03352440|Device|Cerebral Palsy - Kinect|Group with Cerebral Palsy that will perform the task on Kinect
15938616|NCT03352440|Device|Cerebral Palsy - Touchscreen|Group with Cerebral Palsy that will perform the task on Touchscreen
15938617|NCT03352440|Device|Control Group - Kinect|Group with typical development that will perform the task on Kinect
15938618|NCT03352440|Device|Control Group - Touchscreen|Group with typical development that will perform the task on Touchscreen
15938619|NCT03352427|Drug|Dasatinib|60 mg/m2 orally twice daily
15938620|NCT03352427|Drug|Everolimus|3.0 mg/m2, with titration of dosing after first cycle to keep trough level of 5-15 ug/ml
15938621|NCT03352414|Drug|Alvimopan|alvimopan pill
15938622|NCT03352414|Drug|Placebo|placebo pill
15938833|NCT03350607|Other|Non interventional study|Non interventional study (collect of data)
15938623|NCT03352401|Other|Ultrasouund assessment of gastric contents|A qualitative and quantitative ultrasound evaluationof the stomach will be performed when the patient arrives in the pre-anesthesia room. The examination will be held in the right lateral decubitus with a low frequency convex ultrasound probe.
15938624|NCT03352388|Dietary Supplement|Dairy- and berry-based snacks|High-protein dairy-based products and energy-enriched berry products for three months
15938625|NCT03352375|Device|Orotracheally intubation|Interventions used for airway safety and ventilation during surgical procedures
15938626|NCT03352375|Device|Laryngeal Mask Airway|Interventions used for airway safety and ventilation during surgical procedures
15938627|NCT03352362|Drug|ibuprofen (caldolor 10 mg / kg)|Dilution caldolor 10 mg / kg in Hartmann solution to 50 mL - 100 mL and intravenous injection for 30 minutes immediately after induction of anesthesia
15938628|NCT03352362|Drug|propacetamol (denogan 30 mg / kg)|Dilution denogan 30 mg / kg in the dissolved solution to a total of 10 ml and intravenous injection for 10 minutes after the main surgical procedure end
15938629|NCT03352362|Drug|ibuprofen + propacetamol|Dilution caldolor 10 mg / kg in Hartmann solution to 50 mL - 100 mL and intravenous injection for 30 minutes immediately after induction of anesthesia Dilution denogan 30 mg / kg in the dissolved solution to a total of 10 ml and intravenous injection for 10 minutes after the main surgical procedure end
15938630|NCT03352349|Drug|Terlipressinum|If the PVP is over 12 mmHg after hepatectomy, 1mg of Terlipressinum was given to patients intravenously. If the portal vein pressure is decreased by 1 mmHg, then 2mg of Terlipressinum was continuously given every day in the next 4 days after liver resection.
15938631|NCT03352323|Drug|Oxymetazoline|RLD
15938632|NCT03352310|Biological|autologous umbilical cord blood (UCB)|autologous UCB transfusion to the newborn infants presence of HIE and/or anemia within 48 hours after the birth
15938633|NCT03352310|Procedure|standard care|standard care procedure to the newborn infants presence of HIE and/or anemia
15938634|NCT03352297|Biological|Unfiltered Nanofat Graft|Nanofat created from microfat, skipping the filtration step. Intradermal and subdermal injections in post burn scars on the face.
15938635|NCT03352284|Device|Straumann Pure Ceramic Implant|The surgical technique begins with the lift of a vestibular mucoperiosteal flap respecting the papillae of the adjacent teeth. After the alveolar bone is exposed, the sequence of drilling and placement of the intra-bone fixation are carried out. In case of fenestrations or dehiscence, they are treated by xenograft and collagen-absorbable membrane. Once the implant is placed, a healing cap or provisional prosthesis is placed depending on the torque achieved. Finally, the flap is replaced and sutured.
15938636|NCT03352271|Procedure|Individualized Incremental hemodialysis|Individualized Incremental hemodialysis program (twice/week, once/week, once/10days or less frequent) will be provided to incident ESRD patients according to their symptom presentation, clinical examination, investigations and daily urine volume measurement.
15938637|NCT03352271|Procedure|Conventional thrice weekly hemodialysis|Thrice weekly hemodialysis program, the current standard of care for all patients, as a control
15938638|NCT03352258|Radiation|Low dose radiotherapy|10 Gy in 5 fractions of 2 Gy on 5 consecutive days
15938639|NCT03352245|Behavioral|Prescribed Activity|Educational session at enrollment, increase subject communication via tailored electronic messaging, and use of a wrist-bound device (FitBit Flex 2)
15938640|NCT03352232|Combination Product|HBOT and OMT|Hyperbaric oxygen therapy (HBOT) is defined as breathing 100% oxygen at increased atmospheric pressure. Osteopathic manipulative therapy (OMT) is used for myriad ailments including contractures, pain, spasticity. Patients in intervention arms will receive hyperbaric oxygen therapy at 2ATM (atmospheres) for 90minutes daily for up to 6weeks. In addition, they will receive osteopathic manipulative therapies twice a week during the same treatment phase.
15938641|NCT03352219|Behavioral|Reality Check|
15938642|NCT03352219|Behavioral|Physical Activity Attention Control|
15938643|NCT03352206|Drug|2 drug dose - DA|Lymphatic Filariasis Mass Drug Administration (MDA) with the currently used standard of care combination drug therapy of diethylcarbamazine and albendazole (DA)
15938644|NCT03352206|Drug|3 drug dose - IDA|Lymphatic Filariasis Mass Drug Administration (MDA) with triple drug therapy of ivermectin, diethylcarbamazine, and albendazole (IDA)
15938645|NCT03352193|Dietary Supplement|Wheat spaghetti|Wheat oral immunotherapy
15938646|NCT03352180|Procedure|arthroscopic reapir of subscapularis tendon|arthroscopic reapir of massive rotator cuff tears involving the subscapularis.
15938647|NCT03352180|Procedure|arthroscopic debridement of subscapularis tendon|arthroscopic debridement of massive rotator cuff tears involving the subscapularis.
15938648|NCT03352154|Diagnostic Test|P300 - Auditory long latency potential|Perform the P300 exams.
15938649|NCT03352141|Device|The ZELTIQ System|The CoolSculpting machine will be used to perform the treatments.
15938650|NCT03352128|Dietary Supplement|Creatine|Participants will have to supplement themselves with creatine for 7 days (20g/day).
15938651|NCT03352128|Dietary Supplement|Calcium lactate|Participants will have to supplement themselves with calcium lactate for 7 days (elemental calcium: 0.780g/day).
15938652|NCT03352115|Drug|Prednisolone|5 day course of oral prednisolone
15938653|NCT03352115|Drug|Placebos|Placebo syrup
15938654|NCT03352102|Procedure|Electrical stimulation|Neuromuscular electrical stimulation therapy was performed
15938655|NCT03352076|Drug|Vaginal Danazol|Proof of mechanism study to establish intraperitoneal and serum concentrations of Danazol
15938656|NCT03352076|Drug|Oral Danatrol|Proof of mechanism study to establish intraperitoneal and serum concentrations of Danazol
15938657|NCT03352063|Behavioral|Prolonged sitting with exercise|Subjects will commit to sitting more than 11 hours per day and taking less than 5000 steps per day while participating in exercise training.
15938658|NCT03352063|Behavioral|Active walking with exercise.|Subjects will commit to sitting less than 5 hours per day and taking more than 10000 steps per day while participating in exercise training.
15938659|NCT03352050|Dietary Supplement|mushroom|
15938660|NCT03352050|Other|ground beef|
15938661|NCT03352037|Diagnostic Test|PET scan|Patients with known pancreatic cystic lesions requiring MR imaging for lesion characterization for clinical evaluation will be recruited to undergo 18F-FDG PET/MR imaging after written informed consent.
15939277|NCT03347123|Drug|Lirilumab|Lirilumab at the protocol-specified dose and schedule.
15938662|NCT03352024|Other|Relational care|Relational care is combined with a cutaneous anesthesia (Transcutaneous device(plan) of lidocaïne-pilocaïne (EMLA®))
15938663|NCT03352024|Other|Hypno-analgesia|Hypno-analgesia is combined with a cutaneous anesthesia (Transcutaneous device(plan) of lidocaïne-pilocaïne (EMLA®))
15938664|NCT03352011|Behavioral|Primary Care Brief Mindfulness Training|Primary Care Brief Mindfulness Training consists of four 90-minute group classes that teach sitting meditation, body scan, moving meditation, gentle yoga, and group discussion on topics such as non-judging, patience, trust, non-striving, acceptance, and letting go.
15938665|NCT03352011|Behavioral|PTSD Psychoeducational Class|"The PTSD Psychoeducational Class is designed to provide a supportive environment for learning about PTSD-related issues and to help Veterans determine what recovery strategies will be most helpful for them. Session themes include Civilian Readjustment and PTSD, Trust, Safety, and Healing and Treatment Strategies."
15938666|NCT03351998|Drug|Lipitor 20Mg Tablet|20 mg/day pills.
15938667|NCT03351998|Drug|Lipitor 80Mg Tablet|80 mg/day pills.
15938668|NCT03351998|Drug|Placebo Oral Tablet|Matching placebo pill.
15938669|NCT03351985|Device|quantitative electroencephalogram (qEEG)|the patients receive the quantitative electroencephalogram (qEEG) monitoring within 1 hour when they admitted to ICU
15938670|NCT03351972|Drug|Klean Prep|Participants randomised to use polyethylene glycol will follow either routine guidance of taking the bowel prep the night before their capsule endoscopy or receive guidance that they should split their dose between the night before and the morning of the procedure
15938671|NCT03351972|Other|Clear liquids only|Participants randomised to clear liquids only will receive guidance to only drink clear liquids before their procedure
15938672|NCT03351959|Radiation|neo-adjuvant treatment|long-course radio-chemoradiation; short-course radiation with immediate/delayed surgery
15938673|NCT03351946|Procedure|ZEEP|Zero positive end-expiratory pressure (ZEEP) during emergence preoxygenation and awakening.
15938674|NCT03351946|Procedure|PEEP|Positive end-expiratory pressure remains during emergence preoxygenation and awakening and until the study subject is extubated.
15938675|NCT03351933|Biological|Immune Globulin (Human)|A single 0.2 mL/kg IM injection of Immune Globulin (Human) (GamaSTAN) was administered in healthy subjects.
15938676|NCT03351920|Other|mechanical ventilation|All patients who need an invasive or non invasive mechanical ventilation, initiated in Prehospital or IntraHospital Emergency Department by an emergency Physician
15938677|NCT03351894|Procedure|Femtosecond laser assisted cataract surgery|Ziemer Z8 femtosecond laser assisted cataract surgery
15938678|NCT03351894|Procedure|Conventional phacoemulsification|conventional phacoemulsification with infinity phaco
15938679|NCT03351881|Other|Description of Organ Donation Policy|Participants will read about an organ donation policy type (opt-out, opt-in, or opt-neutral) and rate what they think or feel about it.
15938680|NCT03351868|Genetic|Gene-modified autologous stem cells|Infusion for 5x10^6~1x10^7 per kilogram of body weight of gene-modified cells; or more infusions depending on the circumstances
15938681|NCT03351855|Biological|HPV-CTLs|2 to 4 infusions, once a week, for 1x10^5~4x10^6 CTLs/kg by IV each time
15938682|NCT03351842|Drug|cis Platinum/Carboplatin, Pemetrexed Disodium|Intravenous inject Pemetrexed Disodium for Injection over 10 minutes, waiting for at least 30 minutes, then followed by cis Platinum/ Carboplatin over 2 hours
15938683|NCT03351842|Procedure|Undergo surgery|Therapeutic conventional surgery, R0 resection
15938684|NCT03351829|Genetic|Gene-modified autologous stem cells|1 infusion for 5x10^6~1x10^7 gene-modified cells; or more infusions depending on the circumstances
15938685|NCT03351816|Procedure|Ablation of atrial fibrillation|Pulmonary vein isolation by radiofrequency or cryoablation.
15938686|NCT03351816|Procedure|Cardioversion|External electric shock delivery under general anesthesia.
15938687|NCT03351803|Other|BFOR Digital Health solution/Web Portal|A digital health solution with Internet-based participant recruitment and ascertainment is a mechanism for distributing access to genetic testing to populations who might not otherwise have access. For this project, LifeLink will build a private web-portal designed by the PI's of the study as described in this protocol, including the wireframes that are in the appendices, that will enable secure contact between study participants and the participating commercial laboratory (Quest Diagnostics) and BFOR researchers, as well as facilitate contacts between study participants and their primary care providers and/or a list of BFOR study centers and BFOR providers.
15938688|NCT03351790|Other|Questionniare only|A pre-procedure questionnaire will be completed by all participants
15938689|NCT03351777|Drug|PR022|Topical Gel
15938690|NCT03351764|Device|Sham TMS|Subjects receive sham TMS via a coil designed to produce the clicking sound of active TMS without delivering the magnetic field to the brain.
15938691|NCT03351764|Device|TMS|non-invasive transcranial magnetic stimulation is used to temporarily modulation ongoing cortical activity
15938692|NCT03351751|Drug|Placebo|Placebo
15938693|NCT03351751|Drug|PF-06372865|PF-06372865
15938694|NCT03351738|Drug|MEDI5884|Participants will receive SC dose of MEDI5884 50 mg or 100 mg or 200 mg or 350 mg or 500 mg on Days 1, 31, and 61.
15938695|NCT03351738|Drug|Placebo|Participants will receive SC dose of placebo (volume matched to MEDI5884) on Days 1, 31, and 61.
15938696|NCT03351725|Device|peripheral venous catheter (PVC)|No intervention is made only in situ swab from the PVC
15938697|NCT03351712|Behavioral|ACT-Based Intervention and Activity Tracker WITH Feedback|Combining ACT and Behavioral Change
15938698|NCT03351712|Behavioral|Gold Standard Intervention + Activity Tracker WITHOUT Feedback|Medical Rehabilitation, Motivational Support and Psycho-Education
15938699|NCT03351712|Behavioral|Gold Standard Intervention and Activity Tracker WITH Feedback|Behavioral Change Condition - Activity Tracker
15938700|NCT03351712|Behavioral|ACT-Based Intervention and Activity Tracker WITHOUT Feedback|ACT-Based Intervention Standalone
15938701|NCT03351699|Drug|MK-4250|MK-4250 tablets for oral administration
15938702|NCT03351686|Drug|Tranexamic Acid|Tranexamic acid (Kepron, Amoun, Egypt) was given slowly intravenously over 10 minutes just before the skin incision of elective cesarean section to group A. Tranexamic acid injection was prepared by diluting 1g (10 mL) tranexamic acid into 20 ml of 5% glucose.
15938703|NCT03351673|Diagnostic Test|endometrial volume 2D TVS|calculation the endometrial volume using 2D ultrasound and correlation the results with the pathological findings of endometrial biopsy
15938704|NCT03351660|Diagnostic Test|connected ECG|Cardiosecur allows the realization of a 15 or 22 leads ECG with only 4 electrodes connected to a tablet with an automatic interpretation function
15938705|NCT03351647|Biological|Evaluation of biological predictive factors of clinical response to ustekinumab|The clinical response is defined as a decrease in the Crohn's Disease Activity Index (CDAI) score ≥ 100 points or a decrease in the HBI score ≥ 3 points.
15938706|NCT03351634|Device|Implantation of ACT balloon, Uromedica (Irvine, CA, USA) periurethrally at the bladder neck|The ACT system is a permanent implant designed for the correction of incontinence in patients.
15938707|NCT03351608|Drug|Sugammadex 2 mg/kg|For moderate NMB reversal, a single i.v. bolus of sugammadex (2 mg/kg) will be given after final dose of neuromuscular blocking agent (NMBA; rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
15938708|NCT03351608|Drug|Sugammadex 4 mg/kg|For deep NMB reversal, a single i.v. bolus of sugammadex (4 mg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of detection of a target of 1 to 2 post-tetanic counts and no response to TOF stimulations (TOF=0).
15938709|NCT03351608|Drug|Neostigmine + Glycopyrrolate|For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg/kg; up to 5 mg maximum dose) as well as glycopyrrolate (10 μg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
15938710|NCT03351608|Drug|Neostigmine + Atropine|For moderate NMB reversal, a single i.v. bolus containing both neostigmine (50 μg/kg; up to 5 mg maximum dose) as well as atropine (20 μg/kg) will be given after final dose of NMBA (rocuronium or vecuronium) and within 2 minutes of the reappearance of a second twitch (T2) in response to TOF stimulations.
15938711|NCT03351582|Behavioral|Grief and Communication Family Intervention|This intervention is an integrative approach which uses techniques from systemic family therapy as well as cognitive behavioral therapy.
15938712|NCT03351569|Drug|Intravenous immunoglobulin|Intravenous drip.
15938713|NCT03351556|Behavioral|Active Arm 1|Participants in this arm will receive the standard HIV primary care services according to Tanzania's National Guidelines for the Management of HIV and AIDS plus the opportunity to earn 10,000 TZS/month conditional on visit attendance.
15938714|NCT03351556|Behavioral|Active Arm 2|Participants in this arm will receive the standard HIV primary care services according to Tanzania's National Guidelines for the Management of HIV and AIDS plus the opportunity to earn 22,500 TZS/month conditional on visit attendance.
15938715|NCT03351543|Biological|microbial inoculate|volunteers will regularly receive microbial inoculate that they do not use orally
15938716|NCT03351517|Drug|Tapentadol 100 MG|100 mg of oral extended release tapentadol will be given to the patients undergoing total knee replacement surgery on spinal anesthesia to evaluate its efficacy in the management of post-operative pain.
15938717|NCT03351517|Drug|Placebo Oral Tablet|A matching placebo will be given to the patients undergoing total knee replacement surgery on spinal anesthesia to evaluate its efficacy in the management of post-operative pain.
15938718|NCT03351504|Other|Solar lighting system|consisting of a solar panel, rechargeable lead acid battery, charge controller, wiring and switches to 4 lighting points fitted with LED bulbs. This system will include a two-year service warranty.
15938719|NCT03351478|Drug|Sotagliflozin|Sotagliflozin 400 mg was administered as two tablets, once daily before the first meal of the day.
15938720|NCT03351478|Drug|Empagliflozin|Empagliflozin 25 mg capsule was administered, once daily before the first meal of the day.
15938721|NCT03351478|Drug|Placebo|Placebo was administered as two tablets (identical to sotagliflozin in appearance), once daily before the first meal of the day.
15938722|NCT03351478|Drug|Placebo|Placebo was administered as one capsule (identical to the empagliflozin capsule in appearance), once daily before the first meal of the day.
15938723|NCT03351465|Behavioral|Coordinated Anxiety Learning and Management|The intervention for this study, CALM Tools for Living-Il, is a computer-assisted cognitive behavioral therapy for anxiety and depression that guides both the patient and CALM specialist. It is a reformulation of CALM Tools for Living42 that directly incorporates our previously optional modules for depression into the main program. The computerized internet format is designed to retain the fidelity of CBT when delivered by novice clinicians. The program is intended to be delivered in 6 to 8 sessions, although flexibility is allowed.
15938724|NCT03351452|Device|real anodal transcranial direct current stimulation|The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used.
15938725|NCT03351452|Device|real transcranial alternating current stimulation|The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used.
15938726|NCT03351452|Device|sham transcranial electric current stimulation|The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used.
15938727|NCT03351439|Drug|Zopiclone|Group 2 - Zopiclone 7.5 mg orally, nightly for 7 days
15938728|NCT03351439|Drug|Gabapentin|Group 3 - Gabapentin 600 mg orally, 1 hour pre-operatively and 600 mg orally, 8 hours post-operatively
15938729|NCT03351439|Drug|Celebrex|Group 4 - Celebrex 400 mg PO, 1 hour pre-operatively
15938730|NCT03351439|Drug|Percocet|Standard of Care
15938731|NCT03351439|Drug|Naprosyn|Standard of Care
15938732|NCT03351426|Device|Transcranial Direct Current Stimulation (tDCS)|Transcranial Direct Current Stimulation (tDCS) is a noninvasive form of neuromodulation that uses constant, low-intensity direct current delivered via electrodes that are placed on the head.
15938733|NCT03351413|Other|LIVE-LiFE to Prevent Falls Among Older Fallers|"LIVE-LiFE Intervention: Individually tailored program at the participant's home spaced across 12 weeks including:
~Home safety assessment and risk reduction strategies; incorporating strength and balance training into daily habits vision screening and referral; and education about fear of falling and falls
~Home repairs, modifications, and low cost assistive devices to address unsafe home environments increasing fall risk
~Medication review and feedback concerning medications with increased fall risk
~Measurement intervals: Baseline, 4 months, 8 months (with $25 gift card given at each visit for your time)"
15938734|NCT03351400|Biological|Stem cells administered to participants|Patients in this arm will receive intracoronary infusion of 1,000,000 autologous c-kit positive cardiac stem cells.
15938828|NCT03350633|Drug|Tocilizumab Injection|Tocilizumab Injection will be intravenously administered with a dose of 8 mg/kg every 4 weeks.
15938735|NCT03351387|Combination Product|SPY Intra-operative Angiography|The SPY Intra-operative Angiography Fluorescent Imaging System consists of an imaging head equipped with a charged coupled device (CCD) camera, a laser light source and a distance sensor. The imaging head is attached to an articulating arm on a mobile cart containing the central processing unit, keyboard, monitor, and mouse. SPY is used in tandem with indocyanine green (ICG), a water-soluble tricarbocyanine dye. Once the camera is in place, 5 cc of diluted ICG is pushed through an IV line and is flushed immediately; simultaneously the room lights must be dimmed. Perfusion images will be recorded then the SPY system will be removed from the operating room.
15938736|NCT03351374|Other|Software|multi-module system of web software tools
15938737|NCT03351361|Drug|Nivolumab + Ipilimumab|Nivolumab dosed intravenously over 30 minutes at 240 mg every 2 weeks combined with Ipilimumab dosed intravenously over 30 minutes at 1 mg/kg every 6 weeks until disease progression, unacceptable toxicity, or other reasons specified in the protocol.
15938738|NCT03351361|Drug|Chemotherapy|Doublet of chemotherapy according to standard of care carboplatin (AUC 5) with a dose that will be capped to 700 mg and pemetrexed (500 mg/m²) over 4 to 6 hours every three weeks (restricted to non-squamous histology) or carboplatin (AUC 6) with a dose that will be capped to 700 mg and paclitaxel (90 mg/m²) D1 D8 D15 over 4 to 6 hours every 4 weeks, with a maximum of 4 cycles of carboplatin based doublet, and the possibility to use maintenance with pemetrexed.
15938742|NCT03351335|Device|Microfocused ultrasound with visualization|All subjects will receive an Ultherapy® treatment at dual depth using the 4-4.5mm and 7-3.0mm transducers. Treatments will be provided to the lower face, submental (under the chin) and neck area.
15938743|NCT03351322|Drug|ENERGI-F701|ENERGI-F701 are applied for treatment of hair loss.
15938744|NCT03351322|Drug|Regaine|Regaine are applied for treatment of hair loss.
15938745|NCT03351309|Behavioral|Telephone-based Cognitive Behavioral Therapy (CBT)|Four session telephone CBT protocol.
15938746|NCT03351296|Drug|LV5FU2|LV5FU2 (Folinic Acid D, L 400 mg/m² day 1, 5FU 400 mg/m² IV bolus, 5FU 2400 mg/m² 48 hours continuous infusion)
15938747|NCT03351296|Drug|Streptozocin|streptozotocin 800 mg/m² day 1 every 14 days
15938748|NCT03351296|Drug|Capecitabine|Capecitabine 750 mg/m² twice daily, days 1-14
15938749|NCT03351296|Drug|Temozolomide|temozolomide 200 mg/m² once daily, days 10-14, every 28 days
15938750|NCT03351296|Drug|Bevacizumab|bevacizumab 5 mg/kg every 14 days
15938751|NCT03351283|Other|Severe sodium restriction|Patients will be assigned to a diet with sodium restriction of two grams.
15938752|NCT03351283|Other|Moderate sodium restriction|Patients will be assigned to a diet with sodium restriction of three grams.
15938753|NCT03351270|Other|Standardized strength, respiratory and motor function assessments|Standardized assessments will be adjusted by the age, the ambulant status and the respiratory status of the patient. The visit frequency will also be adjusted according to the age and to the time spent in the study varying between quarterly to yearly.
15938754|NCT03351257|Other|observation of surface patterns and colors of polyps|examination of the surface patterns and colors of polyps using Linked color imaging and white-light
15938755|NCT03351244|Drug|BI 409306|28 week treatment period
15938756|NCT03351244|Drug|Placebo|28 week treatment period
15938757|NCT03351231|Drug|BMS-986242|Specified dose on specified days
15938758|NCT03351231|Biological|Nivolumab|Specified dose on specified days
15938759|NCT03351218|Behavioral|Behavioral testing - computerized tasks|Cognitive behavioral testing and cerebral MRI
15938760|NCT03351205|Device|disposable balloon uterine stent|The disposable balloon uterine stent is heart-shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to Foley catheter.
15938761|NCT03351205|Procedure|dried biological amnion graft|"Uterine application of dried biological amnion graft following hysteroscopic adhesiolysis.
~Other Name: Human amnion membrane"
15938762|NCT03351205|Drug|estradiol valerate tablets+dydrogesterone tablets|oral estradiol valerate tablets+dydrogesterone tablets
15938763|NCT03351179|Combination Product|clinical characteristics, previous history, laboratory bio-markers, echocardiographic measurements, angiographic findings,clinical outcomes|The differences of data(clinical characteristics, history, laboratory biomarkers, echocardiographic measurements, angiographic characteristics and clinical outcomes) in two groups were conducted. The differences between two groups were compared (clinical characteristics, history, laboratory biomarkers, echocardiographic measurements, angiographic characteristics and clinical outcomes) in two groups were compared, and then found the risk factors. Following,the incidence of clinical outcomes and mortality were compared. Then, univariate logistic regression and multivariate logistic regression analysis adjusted for significant risk factors were performed to find out the independent predictive factors. Finally, the ROC was constructed, and the area was evaluated to assess the predicted probability of regression model.
15938764|NCT03351166|Drug|Molidustat (BAY85-3934)|Starting dose of molidustat once daily (OD) will be titrated based on the subject's Hb (Hemoglobin) response
15938765|NCT03351153|Radiation|X-ray|In the X-ray group, the changes in femoral head height were measured with X-ray in an anteroposterior position of the pelvis (healthy and affected sides of the hip) at preoperative 1 week
15938766|NCT03351153|Radiation|CT|In the CT group, changes of femoral head height were measured with CT scan on bilateral hips (healthy side and affected side) at preoperative 1 week
15938767|NCT03351153|Other|specimen|In the specimen group, femoral head on the affected side was resected during surgery and directly measured with a ruler and vernier caliper.
15938829|NCT03350633|Drug|Azathioprine|Azathioprine will be orally given at a dose of 2-3 mg/kg/d
15938768|NCT03351140|Other|Qualitative Interviews|Subjects will participate in a qualitative interview lasting up to 90 minutes. The interviews will include a concept elicitation component to explore details of the subject's perceived disease condition, functional limitations and impacts on daily life and health-related quality-of-life (HRQoL). In addition, a card sorting exercise will be used to evaluate the relevance and comprehension of PROMIS Physical Function items.
15938769|NCT03351140|Other|PROMIS Physical Function Items|PROMIS Physical Function Items is a set of self-report measurement tools. The latest version of PROMIS Physical Function Items contains 165 items for self-assessment. PROMIS Physical Function Cancer Item Bank contains a subset of 45 items relevant to cancer subjects. Subjects will complete half of the PROMIS Physical Function Items during their enrollment visit and the other half of items prior to their interview.
15938770|NCT03351127|Radiation|Carotid ultrasound examination|Carotid pulse wave velocity of all participants were measured by ultrafast ultrasound imaging technology using SuperSonic Imagine's Aixplorer ultrasound system.
15938771|NCT03351114|Drug|Crisaborole|Apply Crisaborole 2% ointment to affected skin twice per day.
15938772|NCT03351101|Device|Senofilcon C|Senofilcon C Contact Lens
15938773|NCT03351101|Device|Samfilcon A|Samfilcon A Contact Lens
15938774|NCT03351088|Procedure|DVC ligation|Ligation of the dorsal vascular complex during robot-assisted radical prostatectomy
15938775|NCT03351075|Other|Standard physical therapy program|"Mobilisations, stretching, scar tissue treatment and exercises
~Start immediately after surgery, sessions are individual and take 30 minutes
~Intensive phase (4 months): 1-2x/week
~Maintenance phase (8 months, 3 sessions): 6, 8 and 12 months post-surgery"
15938776|NCT03351075|Other|Modern educational program|"This modern neuroscience educational approach is suited to explain more complex issues associated with pain such as the involvement of peripheral and central mechanisms, neuroplasticity and pain behaviour.
~Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
~3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery"
15938777|NCT03351075|Other|Traditional biomedical educational program|"Traditional educational interventions are applied according to the biomedical model. This means that the patient's pain experience is explained from a tissue (injured versus healthy tissue) and biomechanics perspective
~Sessions are individual and take 30 minutes, in addition to the standard physical therapy sessions
~3 sessions during week 1-2, 3 booster sessions at 6, 8 and 12 months post-surgery"
15938778|NCT03351062|Drug|Tamoxifen|Patients will be given 10mg Tamoxifen twice a day.
15938779|NCT03351062|Drug|Toremifene|Patients will be given 60mg Toremifene once a day.
15938780|NCT03351049|Device|LAL|Reactive support surface with a low air loss feature
15938781|NCT03351049|Device|Non-LAL|Reactive support surface without a low air loss feature
15938782|NCT03351023|Other|no intervention-this was an observational study|
15938783|NCT03351010|Behavioral|Mindfulness training program|The mindfulness training program is a self-awareness mindfulness training program by performing the 15-position hand movement series
15938784|NCT03351010|Device|Cancer pain educational program|A cancer pain education program by using Videos and personalized face-to-face techniques
15938785|NCT03350997|Behavioral|Trial 2 Exercise|During the exercise session, subjects will exercise at 65% of VO2peak. One hour after the exercise session, participants will eat a standardized dinner which will NOT include the energy expended from their exercise session (- 350 kcal).
15938786|NCT03350997|Behavioral|Trial 1 Exercise|During the exercise session, subjects will use a mouthpiece and nose clip (which will allow all of their expired air to pass through the metabolic cart for analysis of oxygen consumption and carbon dioxide production) for ~5 min at the beginning, middle and toward the end of exercise to verify they are exercising at 65% of VO2peak. This will allow us to accurately measure energy expenditure (kcal) during exercise. One hour after the exercise session, participants will eat a standardized dinner which includes the energy expended from their exercise session (+ 350 kcal).
15938787|NCT03350984|Drug|NPH insulin|NPH insulin twice daily, 2/3 in the morning and 1/3 in the night. A correctional dose of lispro insulin will be given for any blood glucose >180 mg/dL.
15938788|NCT03350984|Drug|Glargine and Lispro insulin|Half of the total Glargine and Lispro insulin dose will be given as glargine once daily, either in the morning or in the evening, depending on when the patient was enrolled. The other half of the total daily insulin dose was given as Lispro; doses were divided equally between breakfast, lunch, and dinner.
15938789|NCT03350971|Other|Virtual reality training|training with Wii games, ergometer exercise, ambulation, standing exercises
15938790|NCT03350971|Other|Control|chest physical therapy exercises
15938791|NCT03350958|Dietary Supplement|Alginate Bread|100g Alginate Bread, toasted with 20g of butter.
15938792|NCT03350958|Other|Control Bread|100g standard White Bread (control), toasted with 20g of butter.
15938793|NCT03350945|Procedure|Device: tumor localization|At present, three dominant methods can be available to locate tumor: preoperative endoscopic clip placement, intraoperative endoscopy and endoscopic tattooing
15938794|NCT03350932|Behavioral|Sensory imagination about foods|In both groups, children will be presented with pictures of items. In the control group, the pictures will represent landscapes at different seasons. In the experimental group, the pictures will represent a variety of foods. In the experimental group, based on the pictures representing a variety of foods, children will have to perform a food sensory imagination task before choosing the portion size of a food.
15938795|NCT03350919|Device|Training in the blind field|A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the blind field. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks.
15938824|NCT03350672|Drug|FTC/TAF|Participants in cohorts 1a&b will be administered FTC/TAF for 1 to 7 consecutive days and then be followed clinically for 6 to 14 days. Cohort 2 will participate in a 1 time blood and urine collection.
15938825|NCT03350659|Drug|Midodrine|Midodrine single 5mg/day
15938826|NCT03350659|Drug|Atomoxetine|Atomoxetine single 18mg/day
15938827|NCT03350646|Other|Volume of medium during embryo transfer|
15938796|NCT03350919|Device|Training in the intact field|A computer software and chin-rest necessary to perform visual training will be loaned to each patient to use at home. They will perform one to two daily training sessions in their home, consisting of 200-300 trials each. The visual task performed repetitively will involve discriminating the direction of motion of a small cloud of dots located at a pre-determined location in the intact field of vision. The computer program will automatically create a record of patient performance during each home training session. They will train daily (about 40-60 minutes total), 5 to 7 days per week, for at least 24 weeks.
15938797|NCT03350906|Drug|n3-PUFA|participants will be instructed to swallow 2 softgels twice per day with meals (morning and evening) for a total of 4 softgels per day. The DHA/EPA softgels will each contain ~465mg of EPA and ~375mg of DHA for a total daily dosage of 3.4g/day. Additionally, each capsule will contain SCI's proprietary Advance Lipid TechnologiesTM (ALTTM) containing the surfactants polysorbate 80, NF (~381 mg) and poloxamer 237, NF (~8.8 mg).
15938798|NCT03350906|Drug|Placebo|Patients in this group will be supplemented with placebo capsules containing soybean oil. Participants will be instructed to swallow 2 placebo soft gels twice per day with meals (morning and evening) for a total of 4 soft gels per day. The duration of the intervention will be 6 months.
15938799|NCT03350893|Combination Product|Emulsion base with probiotics|Water、Polyglyceryl-3/ Methylglucose Distearate、Triethyl Hexanoin、Macadamia Ternifolia Seed Oil、Propanediol、PEG/PPG/Polybutylene Glycol-8/5/3 Glycerin、Cetyl Alcohol、Myristyl Myristate、Glycerin、Glycosyl Trehalose/Hydrogenated Starch Hydrolysate、Rice Ferment Filtrate(Sake)、Saccharomyces/Daylily Flower Ferment Filtrate、Bis-PEG/PPG-20/5 PEG/PPG-20/5Dimethicone、Methoxy PEG/PPG-25/4 Dimethicone、Caprylic/Capric Triglyceride、Sodium Polyacrylate、Phenoxyethanol、o-Cymen-5-ol、Xanthan Gum、Potassium Hydroxide, Heat-killed L. plantarum powders (1x10^9 cells/ g-cream)
15938800|NCT03350893|Other|Emulsion base|Water、Polyglyceryl-3/ Methylglucose Distearate、Triethyl Hexanoin、Macadamia Ternifolia Seed Oil、Propanediol、PEG/PPG/Polybutylene Glycol-8/5/3 Glycerin、Cetyl Alcohol、Myristyl Myristate、Glycerin、Glycosyl Trehalose/Hydrogenated Starch Hydrolysate、Rice Ferment Filtrate(Sake)、Saccharomyces/Daylily Flower Ferment Filtrate、Bis-PEG/PPG-20/5 PEG/PPG-20/5Dimethicone、Methoxy PEG/PPG-25/4 Dimethicone、Caprylic/Capric Triglyceride、Sodium Polyacrylate、Phenoxyethanol、o-Cymen-5-ol、Xanthan Gum、Potassium Hydroxide
15938801|NCT03350880|Other|Flexibility training|Flexibility training was carried out over a period of six weeks, with two sessions per week, totaling 12 sessions.
15938802|NCT03350867|Other|Personalized Insole Group|Personalized Insole Group
15938803|NCT03350867|Other|Placebo Group|Placebo Group
15938804|NCT03350854|Behavioral|Patient Preference in Treatment Decision Making|The roles are divided into two active roles, a collaborative (or shared) role, and two passive roles in the Patient Preference scale questionnaire. Once the questionnaire is administered, the patient will then proceed to original surgical appointment. The provider is informed of the patient's preferred role and has a discussion with them patient about this in the intervention group, but not in the control group.
15938805|NCT03350841|Procedure|Platelet rich plasma PRP|blood sample is collected to prepare platelet rich plasma injected in the canal
15938806|NCT03350841|Procedure|root canal treatment|conventional root canal treatment and obturation with guttapercha
15938810|NCT03350802|Diagnostic Test|procalcitonin test|All patients enrolled in this cohort undergo procalcitonin test in addition to basic microbiological test.
15938811|NCT03350789|Device|Real acupuncture|manual acupuncture(0.25mm diameter x 40mm length, stainless steel, Dongbangacupuncture Inc., Korea) (unilateral GB30) + electroacupuncture(0.25mm diameter x 40mm length, stainless steel, Dongbangacupuncture Inc., Korea) (unilateral EX-B2 (L4 & L5), BL25, BL23, BL40, GB34), twice a week, for 4 weeks, common approaches for the treatment of chronic sciatica used by doctors of Korean medicine in Korea today
15938812|NCT03350789|Device|Sham acupuncture|sham acupuncture without skin penetration(0.25mm diameter x 40mm length, stainless steel, Acuprime, UK) (unilateral GB30) + placebo electroacupuncture (0.25mm diameter x 40mm length, stainless steel, Dongbangacupuncture Inc., Korea) without electrical stimulation (unilateral EX-B2, BL25, BL23, BL40, GB34), twice a week, for 4 weeks
15938813|NCT03350776|Behavioral|Care coordination|Care coordination and associated emerging occupations by comparing theoretical expected outcomes to professionals, patients and caregivers representations
15938814|NCT03350763|Device|Tannenbaum 10 Fr biliary stent|Tannenbaum 10 Fr biliary stent
15938815|NCT03350763|Device|Self-expandable metallic biliary stent|ie WallFlex biliary RX
15938816|NCT03350750|Device|programmable CSF shunt valve|Brain shunt surgery using a programmable CSF shunt valve
15938817|NCT03350737|Other|Physical rehabilitation|Standard treadmill exercise session
15938818|NCT03350737|Drug|Heparin|Heparin i.v.
15938819|NCT03350737|Other|Placebo|Sodium Chloride 0.9% i.v.
15938820|NCT03350724|Device|episil wound dressing|Episil is a wound dressing material intended for the management of pain and relief of pain by adhering to the mucosal surface of the mouth, soothing oral lesions of various etiologies. episil is an oromucosal liquid that transforms in situ to a bioadhesive oromucosal gel by uptake of small amounts of aqueous fluid.
15938821|NCT03350724|Device|PeriAcryl90 wound dressing|PeriAcryl90 is a cyanoacrylate wound dressing.
15938822|NCT03350711|Other|Microbiota Enrichment Program (MEP)|"Registry participants will provide demographic and medical information and may take part in general screening procedures to facilitate enrolling into an appropriate FMT study.
~Once determined to be eligible for study entry, study-specific screening procedures may include:
~Health history and physical examination
~Urinalysis
~Urine or serum pregnancy test
~Blood tests for Hepatitis B, Hepatitis C, HIV, chemistry panel (which includes liver function, kidney function), complete blood count with differential, platelet count, partial thromboplastin time (PTT), international normalized ratio (INR)
~Electrocardiogram (EKG or ECG)
~Stool studies
~Participants will be re-screened every 6 months and will remain in follow-up indefinitely or until they are rendered ineligible, participate in a MEP study, or withdraw consent to be included in the database."
15938823|NCT03350698|Biological|Gardasil-9|3 vaccine series
15938830|NCT03350620|Drug|NVK-002 Concentration 1|Study medication will be administered, once daily (QD)
15938834|NCT03350594|Behavioral|Systemic Family Therapy|Patient will have 10 sessions of Systemic Family Therapy during 12 months with his/her family.
15938835|NCT03350594|Behavioral|Multiple Family Therapy|Patient and his/fer family will have 10 sessions of Multiple Family Therapy during 12 months.
15938836|NCT03350581|Procedure|FAM 3D map group|Radiofrequency catheter ablation using the 3D map which is constructed by FAM alone.
15938837|NCT03350581|Procedure|FAM-CT 3D map group|Radiofrequency catheter ablation using the 3D map which is constructed by the integration of the FAM with CT or MRI.
15938838|NCT03350568|Other|Total dietary NEAC assessed at baseline|
15938839|NCT03350555|Device|Additioned Endoscopy|To evaluate the use of additioned endoscopy in ERCP treatment.
15938840|NCT03350542|Device|SYNERGY 48 mm|A drug eluting coronary stent system
15938841|NCT03350529|Device|MRI guided transurethral HIFU ablation of prostatic tissue|The technology is developed to ablate targeted benign and malignant prostate tissue through transurethrally inserted probe that transmit ultrasound energy under MRI guidance and control. The therapeutic endpoint of this method is thermal coagulation of prostate tissue.
15938842|NCT03350516|Dietary Supplement|Daily 500 mg elemental calcium as calcium carbonate|Pregnant women in this arm will be provided and counselled to take three tablets, one containing 500 mg elemental calcium as calcium carbonate and 2 placebo supplements daily (total of 500 mg daily). The supplements in India will also contain 83.3 IU each of vitamin D3, for a total of 250 IU daily. No vitamin D3 will be given in Tanzania.
15938843|NCT03350516|Dietary Supplement|Daily1500 mg elemental calcium as calcium carbonate|Pregnant women in this arm will be provided and counselled to take three tablets each containing 500 mg elemental calcium as calcium carbonate daily (total of 1500 mg daily) as currently recommended by the World Health Organization. The supplements in India will also contain 83.3 IU each of vitamin D3, for a total of 250 IU daily. No vitamin D3 will be given in Tanzania.
15938844|NCT03350503|Device|AcrySof IQ Toric A-code IOL|Intended to provide visual acuity, including astigmatism correction, over the lifetime of the cataract patient
15938845|NCT03350503|Procedure|Cataract surgery|Removal of cataractous lens and implantation of IOL
15938846|NCT03350490|Device|Cancer ablation|Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound.
15938847|NCT03350490|Drug|Life information rehabilitation therapy|Each treatment: one bottle solution each day, consecutive 3 months, oral administration
15938848|NCT03350477|Device|Cancer ablation|Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound.
15938849|NCT03350477|Drug|Life information rehabilitation therapy|Each treatment: one bottle solution each day, consecutive 3 months, oral administration
15938850|NCT03350464|Device|Repetitive Transcranial Magnetic Stimulation|Transcranial magnetic stimulation (TMS) is a non-invasive method that uses electromagnetic induction to produce electric currents in the cortex that are strong enough to depolarise neurons sufficiently to trigger action potentials. It is an outpatient based procedure that when used in conjunction with a neuro-navigation system, specific cortical areas can be targeted for greater accuracy and efficacy. In clinical studies, TMS is delivered as trains of pulses (repetitive TMS, rTMS) to prolong its effects. While the exact mechanism of TMS-induced analgesia is unknown, it is thought to regulate the activity of the complex cortical and subcortical networks involved in the processing of painful signals and possibly strengthening the endogenous descending pain modulation system
15938851|NCT03350451|Drug|Lumasiran|Multiple doses of lumasiran by subcutaneous (sc) injection
15938852|NCT03350399|Diagnostic Test|placenta growth factor|estimation level of derum placenta growth factor
15938853|NCT03350386|Drug|FYU-981|Single administration
15938854|NCT03350386|Drug|Oxaprozin|Repeated administration
15938855|NCT03350373|Drug|FYU-981|Single administration of FYU-981 under Fasted and fed conditions in the morning.
15938856|NCT03350360|Behavioral|Attention Control Training|Attention control training teaches participants that the emotional salience of cues (i.e., threatening or neutral) is not related to successful completion of the computerized response task, and thus, teaches participants to ignore irrelevant threat-related contingencies (Badura-Brack et al., 2015).
15938857|NCT03350360|Behavioral|Comparison Task|Neutral- neutral stimuli prior to response task
15938858|NCT03350347|Drug|Molidustat (BAY85-3934)|Starting dose of 25 mg or 50 mg molidustat once daily (OD) will be titrated based on the subject's Hb response
15938859|NCT03350347|Drug|Darbepoetin alfa|Starting dose and frequency of darbepoetin alfa are based on previous ESA. The dose will be titrated based on the subject's Hb response
15938860|NCT03350334|Drug|Duloxetine|Peri-operative Duloxetine administration
15938861|NCT03350334|Drug|placebo|Placebo administration
15938862|NCT03350321|Drug|Molidustat (BAY85-3934)|Starting dose of molidustat once daily (OD) will be titrated based on the subject's Hb (Hemoglobin) response
15938863|NCT03350321|Drug|Darbepoetin alfa|Starting dose of darbepoetin alfa once every 2 weeks will be titrated based on the subject's Hb (Hemoglobin) response
15938864|NCT03350308|Other|hemodialysis|The main objective is to establish a statistical predictive model of the risk of intradialytic hypotension during hemodialysis (HD) or hemodiafiltration (HDF) sessions based on the measurement of residual blood volume and excess extracellular hydration
15938865|NCT03350295|Drug|Nifurtimox (Lampit, BAYA2502)|Oral Intake of 4 x 30 mg nifurtimox tablets for treatment A-C; Oral Intake of 1 x 30 mg nifurtimox tablets for treatment D Oral intake of 1 x 120 mg nifurtimox tablet for treatment E
15938866|NCT03350282|Dietary Supplement|GAA-creatine|
15938867|NCT03350282|Dietary Supplement|Creatine|
15938868|NCT03350269|Other|Information provision|Kidney transplant recipients are informed that their donors may be eligible for lost wage reimbursement
15938869|NCT03350256|Device|Stimulation will be delivered at with different microdosing setting to identify the optimal parameter values for each patient.|BurstDR spinal cord stimulation will be delivered with different ON/OFF periods to identify the best setting for each patients.
15938870|NCT03350243|Other|CCENT Intervention|"Acceptance and Commitment Therapy approach: engaging families through structured individual or group sessions within the NICU and continue this support once discharged.
~Care coordination: supporting providers in clear communication when liaising across various levels of care as well as supporting families in system and resource navigation.
~Anticipatory guidance: proactive education targeting normal challenges in caring for a child who required intensive care support."
15938871|NCT03350217|Drug|Eleview|If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
15938872|NCT03350217|Drug|Hetastarch|If a lesion in the colon is found to fit the description listed in the protocol, the subject will be randomized to Eleview or Hetastarch as the injectate solution for the procedure. The injectate solution is used, as needed, to aid in the resection of the target lesion.
15938873|NCT03350204|Procedure|Meniscectomy|This will be to see what occurs in both kinetics and kinematics after you have a surgery and how this links on to osteoarthritis
15938874|NCT03350204|Other|Helathy control comparison|This group will be used to get a baseline for normal and natural walking, running and other several tasks which will be used as a comparison for the meniscus injury group.
15938875|NCT03350191|Drug|SAR425899|"Pharmaceutical form: Solution for injection
~Route of administration: Subcutaneous"
15938876|NCT03350191|Drug|[68Ga] Ga-DO3A-VS-Cys40-Tuna-2 (glucagon receptor tracer)|"Pharmaceutical form: Solution for injection
~Route of administration: Subcutaneous"
15938877|NCT03350191|Drug|[68Ga] Ga-DO3A-VS-Cys40-Exendin-4 (GLP-1 receptor tracer)|"Pharmaceutical form: Solution for injection
~Route of administration: Subcutaneous"
15938878|NCT03350178|Drug|fecal microbiota transfer|transfer of fecal microbiota from healthy donor to the patients
15938879|NCT03350165|Drug|K-877|0.2mg tablet
15938880|NCT03350165|Drug|Placebo|K-877 matching placebo tablet
15938881|NCT03350139|Device|gamma knife radiosurgery|The surgical procedure consists of a very partial radiation of the brain with a stereotactic precision performed in current practice
15938882|NCT03350126|Drug|Ipilimumab 200 MG in 40 ML Injection|"Induction therapy (12 weeks):
~Nivolumab 3mg/kg intravenously (IV) over 60 minutes and Ipilimumab 1mg/kg (IV) over 90 minutes Q3W"
15938883|NCT03350126|Drug|Nivolumab 10 MG/ML|"Induction therapy (12 weeks) :
~Nivolumab 3mg/kg intravenously (IV) over 60 minutes and Ipilimumab 1mg/kg (IV) over 90 minutes Q3W
~Maintenance therapy (40 weeks):
~Nivolumab monotherapy IV over 60 minutes Q2W until iRECIST progression or if no PD for one year."
15938884|NCT03350113|Device|Blood sampling for analysis|Blood Sampling for Analysis
15938885|NCT03350100|Dietary Supplement|Acute effect of two Saudi cultivars of date fruit on mood and cognitive performance|Acute effect of two Saudi cultivars of date fruit on mood and cognitive performance at baseline, 45 post-dose, 90 min post-dose and 135 min post-dose
15938886|NCT03350087|Device|intermittent theta burst stimulation|"In intermittent theta burst stimulation pattern (iTBS) will intermittently give a 2 s train of TBS every 10s repeated 2 times for a total of 40 times (low pulse: 1200 pulses in total)
~Other Names:
~intermittent theta burst stimulation"
15938887|NCT03350087|Device|continuous theta burst stimulation|"In continuous burst stimulation pattern (cTBS) will intermittently give a cTBS treatment consists of a continuous train of TBS for 40 seconds repeated for 2 times(low pulse: 1200 pulses in total).
~Other Names:
~continuous burst stimulation"
15938888|NCT03350087|Device|iTBS+cTBS group|In iTBS+cTBS pattern, continuous cTBS will be followed by intermittent iTBS (low pulse; 1200 pulses in total)
15938889|NCT03350087|Device|sham theta burst stimulation|"In sham burst stimulation pattern (sham TBS) will intermittently give a sham TBS treatment consists of a continuous train of TBS for 40 seconds(almost no pulse: 1200 pulses in total).
~Other Names:
~sham theta burst stimulation"
15938890|NCT03350087|Device|VCT|"The UE VCT programs were conducted three times per week, for 12 weeks. Each UE VCT session involved upper limb cycling training followed by UE training in addition to home program. The cycling program consisted of a warm-up exercise, twenty repetitions of hand push-up movements in the sitting position, UE cycling, and a cool-down exercise. The warm-up and cool-down exercises involved stretching and relaxing the head, neck, and the upper and lower body.
~Other Names:
~The upper extremity programs virtual cycling training program"
15938891|NCT03350087|Device|VCT+optimal rTMS group|In VCT+optimal rTMS group, VCT will be combined with optimal rTMS, which has the best outcome in phase 1.
15938892|NCT03350061|Device|SENSY|The sensory feedback will be delivered by SENSY with or without the leg prosthesis. Benefits connected to the stimulation of sensory nerves will be assessed.
15938893|NCT03350048|Diagnostic Test|Trans-Dot point-of-care test|"Training set participants will be recruited and receive investigations for TB. Blood samples will also be collected from them for performance of ELISAs and laboratory-based TransDot tests. These blood samples will be drawn at baseline, week 8 and week 24 at end of treatment for confirmed TB cases and at baseline for non-TB cases.
~Test set participants will be recruited and receive investigations for TB. A POC TransDot test will be performed on fingerprick blood at baseline, and at week 8 and week 24 in participants on TB treatment, as well as a laboratory based TransDot test on serum at baseline. The week 8 and week 24 TransDot tests will be used to investigate the test's utility as an indicator of treatment response."
15938894|NCT03350035|Drug|IV Ganaxolone active|IV
15938895|NCT03350035|Drug|IV Placebo, non-active|IV
15938896|NCT03350022|Procedure|Sham Feeding|Sham feeding will be offered to participants.
15938897|NCT03349996|Device|LifeStream Peripheral Stent Graft System|Patients will be treated with the LifeStream Peripheral Stent Graft System
15938898|NCT03349983|Biological|MVA-BN-Brachyury/ FPV-Brachyury|Two priming doses of MVA-BN-Brachyury followed by boost doses of FPV-Brachyury monthly for 6 months
15938899|NCT03349957|Drug|Transarterial chemoembolization using TANDEM and idarubicin|Transarterial chemoembolization using TANDEM and idarubicin
15938900|NCT03349944|Behavioral|Training|The duration of the training intervention is 10 weeks of either moderate exercise og high intensity interval training.
15938901|NCT03349931|Diagnostic Test|DNA extraction and detection of Aspergillus fumigatus in serum samples|Performances diagnostic test of the real-time PCR ADEMTECH kit of DNA extraction and detection of Aspergillus fumigatus in serum samples in patients at high-risk for invasive aspergillosis (IA).
15938902|NCT03349918|Behavioral|Mobile Health Monitoring|Use of mobile health application to monitor blood pressure and mood.
15938903|NCT03349905|Procedure|fresh transfer|"Women randomized in the non experimental group will have:
~Antagonist stimulation protocol
~Ovarian triggering using a single injection of rhCG (Ovitrelle®; Serono, France)
~All of their embryo kept in prolonged culture
~A fresh single embryo transfer at blastocyst stage (on day 5 or 6 according to blastocyst stage)
~Supernumerary blastocysts cryopreserved"
15938904|NCT03349905|Procedure|Deferred-frozen embryo transfer|"Women randomized in the experimental group will have:
~Antagonist stimulation protocol
~Ovarian triggering using a single injection of 0.2 mg of GnRH agonist triptorelin (Decapeptyl® Ipsen France)
~All of their embryo cryopreserved at the blastocyst stage after prolonged embryo culture.
~A frozen-thawed single embryo transfer at blastocyst stage, is planned 3-11 weeks after cryopreservation"
15938905|NCT03349892|Radiation|Stereotactic Ablative Radiotherapy (SABR)|A single fraction of radiation is delivered using a clinical radiotherapy system capable of stereotactic radiotherapy to the chest, with on-board image guided radiotherapy capabilities, respiratory motion management, and Intensity Modulated Radiotherapy Treatment (IMRT) planning.
15938906|NCT03349866|Drug|apatinib|apatinib：250mg qd po
15938907|NCT03349866|Drug|Capecitabine|1000mg/m2 bid d1-14
15938908|NCT03349866|Drug|Oxaliplatin|130 mg/m2 Ivgtt d1 q3w
15938909|NCT03349866|Radiation|Radiotherapy|45Gy/25f （1.8Gy/f/d，5 f/w）
15938910|NCT03349840|Drug|Insulin Degludec U100|Patients on any basal insulin including insulin glargine will be randomised and converted to basal degludec insulin
15938911|NCT03349840|Drug|Insulin Glargine|Patients on any basal insulin including insulin glargine will be randomised and either glargine will be continued or will beconverted to basal glargine insulin
15938912|NCT03349827|Procedure|exploratory laparoscopy or laparotomy|Exploratory laparoscopy or laparotomy, for PCI score or radical gastrectomy and cytoreductive surgery
15938913|NCT03349827|Procedure|HIPEC|Normal saline 3000ml-4000ml, Docetaxel 50mg/m2, Lobaplatin 50mg/m2, 43°C, 60min.
15938914|NCT03349827|Drug|Systemic chemotherapy|Oxaliplatin: 130mg/m2, day 1. S1: 60mg, twice daily, day 1 to day 14. S1:60mg twice daily for two weeks, and then suspend for one week
15938915|NCT03349827|Drug|Apatinib|500mg, once daily, day 1 to day 21.
15938916|NCT03349814|Procedure|Diagnostic laparoscopy without appendectomy|A diagnostic laparoscopy where the appendix is not found to be inflamed, and therefore is not removed.
15938917|NCT03349814|Procedure|Diagnostic laparoscopy with appendectomy|A diagnostic laparoscopy where the appendix seems inflamed, and therefore is removed
15938918|NCT03349801|Other|No intervention|According to clinical practice.
15938919|NCT03349788|Procedure|LCA-nP|The group underwent lapaoroscopic radical rectectomy without preserving left colic artery.
15938920|NCT03349788|Procedure|LCA-P|The group underwent lapaoroscopic radical rectectomy with preserving left colic artery.
15938921|NCT03349775|Drug|Metformin|One capsule by mouth twice a day, followed by an increase to two capsules by mouth twice a day for a total of 3 months
15938922|NCT03349775|Drug|Placebo|One capsule by mouth twice a day, followed by an increase to two capsules by mouth twice a day for a total of 3 months
15938923|NCT03349749|Device|LiDCOplus haemodynamic monitor|Patients in study group receive intravenous fluid bolus as part of standard fluid resuscitation. Fluid responsiveness (i.e. improvement in cardiac output) is estimated using both standard clinical parameters and by LiDCOplus haemodynamic monitor (with the clinician initially blinded to the latter) before a final decision about fluid responsiveness is made.
15938924|NCT03349736|Other|Pelvic Floor Muscle Training|All the women will receive information and instruction/guidance exercise individually and in groups on PFMT on the first day of their visit. Following this, the women are advised to perform daily PFMT at home which includes 10 sec hold X 10 times X 3 sets. Women will record their home PFMT using an exercise diary. During the follow-up, women will attend the PFMT in a group or individual led by a Physiotherapists (to motivate and to ensure women are performing the PFMT correctly). Exercise diary will be collected in every follow up so that the information is retained even if the women discontinued or deviate from intervention protocols.
15938925|NCT03349723|Drug|BI 1265162|Single rising dose groups
15938926|NCT03349723|Drug|Placebo|Single rising dose groups
15938927|NCT03349710|Biological|Nivolumab|Specified dose on specified day
15938928|NCT03349710|Drug|Cetuximab|Specified dose on specified day
15938929|NCT03349710|Drug|Cisplatin|Specified dose on specified day
15938930|NCT03349710|Radiation|Radiotherapy|Specified dose on specified day
15938931|NCT03349697|Dietary Supplement|Phyllantus amarus|
15938932|NCT03349697|Other|Placebo|
15938933|NCT03349684|Drug|Acarbose|Uptitrated in the treatment phase from 50 mg per day for 1 week, followed by 100 mg per day for another week, and 150 mg per day for the rest 14 weeks, oral, with the first mouthful of main meal
15938934|NCT03349684|Drug|Metformin|500 mg 3 times daily, oral, with the first mouthful of main meal
15938935|NCT03349684|Drug|Placebo|Acarbose matching placebo, oral
15938936|NCT03349671|Procedure|ultrasound|A 3D volume of the uterus will be acquired by transabdominal sonography. The sweep angle was set at 85º and the probe will be kept perpendicular to the placental plate. The placenta will be examined and the size of the volume box will be adapted in such a way that the placenta fitted into it completely. The volume will then stored for later offline analysis.
15938937|NCT03349658|Other|general anesthesia|effect of general anesthesia on transcranial regional cerebral oxygen saturation
15938938|NCT03349658|Other|spinal anesthesia|effect of spinal anesthesia on transcranial regional cerebral oxygen saturation
15938939|NCT03349645|Biological|Ampion|Ampion (<5 kilodalton (kDa) ultrafiltrate of 5% Human Serum Albumin (HSA), solution, 4 mL
15938940|NCT03349632|Device|verofilcon A contact lenses|Investigational spherical silicone hydrogel contact lenses for daily disposable wear
15938941|NCT03349632|Device|senofilcon A contact lenses|Commercially available spherical silicone hydrogel contact lenses for daily disposable wear
15938942|NCT03349632|Device|stenfilcon A contact lenses|Commercially available spherical silicone hydrogel contact lenses for daily disposable wear
15938943|NCT03349632|Device|etafilcon A contact lenses|Commercially available spherical silicone hydrogel contact lenses for daily disposable wear
15938944|NCT03349619|Drug|Resveratrol plus Carboxymethyl-β-Glucan|Patients in this arm will receive Resveratrol plus Carboxymethyl-β-Glucan, two sprays (100µL/spray) per nostril three times/day for 4 weeks
15938945|NCT03349619|Drug|Placebo|Patients in this arm will receive nasal saline solution 0.9%, two sprays per nostril, three times/day for 4 weeks
15938946|NCT03349606|Drug|d-amphetamine|oral d- amphetamine 0.5 mg/kg is used to stimulate dopamine release in the brain
15938947|NCT03349606|Radiation|[C-11]FLB 457|PET radiotracer
15938948|NCT03349593|Diagnostic Test|Echocardiography|Preoperative transthoracic echocardiography
15938949|NCT03349580|Behavioral|The training group|The training group performed rehabilitation program twice per week over 9 weeks. The group commenced rehabilitation 3 weeks after the surgery. During the phase one training (week 1 to week 5), the isometric exercises were preformed on the trunk extension, flexion and lateral flexion muscles. During the phase 2 (week 6 to week 9), the exercises were performed on the strength machines and duration of the exercises were maintained and prolonged to 30 seconds. The leg adduction and hip extension exercises were added. The patients were instructed to perform abdominal bracing (IAP) and maintain the neutral position of their lumbar spine before and during the exercises.
15938950|NCT03349567|Behavioral|Audit-and-feedback|We will monitor the antimicrobial-prescribing of providers in the experimental arm. Our study team will meet with providers in the experimental arm to provide guidance on optimal antimicrobial-prescribing. We will provide personalized feedback to providers in the experimental arm once every quarter.
15938951|NCT03349554|Other|body-scan meditation|15 minutes audio-guided body-scan meditation
15938952|NCT03349554|Diagnostic Test|Psychological evaluation|"NPI (Neuropsychiatric symptoms Inventory) - PAS (Parkinson's disease Anxiety Screening Questionnaire) - VAS measuring pain, anxiety and discomfort Before and after body-scan meditation"
15938953|NCT03349541|Other|Complex Care Curriculum|"A well-established approach to curriculum development was utilized to develop competency-based objectives aligned with the Canadian CanMEDS Physician Competency Framework, identify appropriate educational strategies and design relevant evaluations."
15938954|NCT03349528|Biological|Probiotic Supplement|Probiotic supplement 1 tablet by mouth daily
15938955|NCT03349528|Biological|Inert Compound|Probiotic identical placebo 1 tablet by mouth daily
15938956|NCT03349515|Drug|Provodine-Iodine Solution|Group A will receive three drops of povidone-iodine ophthalmic solution in each eye, with the right eye to receive the drops first. The eye drops will be administered by the study anesthesiologist. After application of either solution to the eyes of the patient, any change in ventilation can be detected and timed by observation of the capnography (end-tidal carbon dioxide) and direct observation of the chest wall with use of the iPhone stopwatch feature again. The capnograph is a standard monitor of respiration used during the administration of general anesthesia. Data collected at this time will include whether or not there was a change in respiration, what this change in respiration was, if assisted ventilation was required, how long assisted ventilation was required (if applicable), HR, BP, RR, SaO2 , ETCO2, InspSevo, and ExpSevo. This study intervention and data collection will take less than 5 minutes.
15938957|NCT03349515|Drug|Group B will receive three drops in each eye of ophthalmic balanced salt solution.|Group B will receive three drops in each eye of ophthalmic balanced salt solution. The eye drops will be administered by the study anesthesiologist. After application of either solution to the eyes of the patient, any change in ventilation can be detected and timed by observation of the capnography (end-tidal carbon dioxide) and direct observation of the chest wall with use of the iPhone stopwatch feature again. The capnograph is a standard monitor of respiration used during the administration of general anesthesia. Data collected at this time will include whether or not there was a change in respiration, what this change in respiration was, if assisted ventilation was required, how long assisted ventilation was required (if applicable), HR, BP, RR, SaO2 , ETCO2, InspSevo, and ExpSevo. This study intervention and data collection will take less than 5 minutes
15938958|NCT03349502|Drug|MG4101|Administration of study drug (MG4101) for the patients with refractory or relapsed acute myeloid leukemia (Single arm)
15938959|NCT03349489|Other|Exercise 1|Participants will be admitted at the research center at 14:00. At 14:30, participant's insulin basal rate will be reduced by 80%. At 16:00, participants will perform a 60-minute exercise on a stationary bicycle at 60% of their maximal cardiorespiratory capacity (VO2 max). During the exercise period, muscle oxygenation and muscle oxygen extraction will be measure by near infrared spectroscopy. Glucose levels will be measured every 10 minutes during the exercise period. At 17:30, the participant will be discharged.
15938960|NCT03349489|Other|Exercise 2|Participants will be admitted at the research center at 14:00. At 15:20, participant's insulin basal rate will be reduced by 80%. At 16:00, participants will perform a 60-minute exercise on a stationary bicycle at 60% of their maximal cardiorespiratory capacity (VO2 max). During the exercise period, muscle oxygenation and muscle oxygen extraction will be measure by near infrared spectroscopy. Glucose levels will be measured every 10 minutes during the exercise period. At 17:30, the participant will be discharged.
15938961|NCT03349489|Device|Dexcom G4 Platinum|The Dexcom G4 Platinum will be used to measure continuous glucose levels.
15938962|NCT03349489|Drug|Insulin|Participant's usual fast-acting insulin analog will be used.
15938963|NCT03349489|Device|Insulin pump|Participant's insulin pump will be used to infuse insulin.
15938964|NCT03349476|Device|MFAM|"Specifically, the mFAM Workstation accesses stored data of recorded electronic heart activity that has been obtained by conventional electrophysiological methods, using multi-electrode catheters placed in the heart (data inputs) for collection. Using proprietary software algorithms, the mFAM Workstation analyzes these data inputs and generates 3D anatomical structure.
~mFAM improves on the FAM functionality by applying a model-based approach for reconstruction of left atrial chamber anatomy"
15938965|NCT03349463|Drug|Fluciclovine F18|All study participants will receive 10 mCi of 18F-Fluciclovine (Axumin) one time administered through injection through the catheter into participant's arm immediately before PET/CT scan.
15938966|NCT03349450|Biological|DPX-Survivac|DPX-Survivac Priming dose of 0.5ml on Study days 7 and 28. DPX-Survivac Booster dose of 0.1ml on Study days 84, 140, 196, 252, 308, and 364.
15938967|NCT03349450|Biological|Pembrolizumab|Pembrolizumab 200mg administered intravenously every 3 weeks, commencing on study day 7 to a total of 18 infusions
15938968|NCT03349450|Drug|Cyclophosphamide 50mg|Cyclophosphamide 50mg twice daily by mouth, administered 7 days on / 7 days off, stating at study day 0, until study day 384
15938969|NCT03349437|Device|Vitabreath Device|The VitaBreath device is designed for non-continuous use only and typical device use is expected to be for 2-3 minutes. The device should only be operated for less than 10 minutes at a time. After such time, the device should be turned off for at least 30 minutes
15938970|NCT03349437|Other|Pursed Lip Breathing|Pursed lip breathing (PLB) is the standard of care and will be used as the control condition comparator.
15939042|NCT03348943|Behavioral|Right hemiparesis, left upper limb|Individuals with right hemiparesis Cerebral Palsy that will perform the tasks with the non-affected upper limb.
15938971|NCT03349424|Drug|Somatostatin|Patients in the Stilamin group will be continuous intravenous infusion with the somatostatin (Stilamin®) of 250μg/h, beginning within 3 hours (Visit 1) after the operation and lasting for 120 hours (each subject will receive the Stilamin of 30mg in total), and other postoperative conventional treatment protocol remain unchanged.
15938972|NCT03349411|Diagnostic Test|Confusion Assessment Method|This test is used for delirium assessment. The CAM consists of a series of questions, measuring attention (digits forward and backwards, days of the week and months of the year backwards), orientation (person, place, time), memory (immediate and delayed recall of 3 concrete nouns); and probing for any sleep, perceptual, or thinking disturbances. It was designed to incorporate DSM-III criteria for delirium.
15938973|NCT03349411|Diagnostic Test|Behavioral Inattention Test|This test is used for neglect assessment. The BIT consists of 6 tasks: figure and shape copying; line, star, and letter cancellation, and representational drawing. Such tasks were shown to be appropriate in patients within 48 hours of stroke onset. Scoring of each test will include proportion of error responses on each test or deviation from midpoint on line bisection. Figure and shape copying and representational drawing will be scored based on each item completed.
15938974|NCT03349411|Diagnostic Test|Magnetic Resonance Imaging|Structural, functional and diffusion weighted scans will be obtained or acquired, depending on the cohort. Subacute sample participants will undergo a research MRI scan, whereas acute sample participants will allow the release of their clinical MRI scans.
15938975|NCT03349411|Diagnostic Test|Florida Mental Status Examination|This test is used for mental status assessment, and it will be conducted in our subacute sample only. The FMSE tests memory, attention, language, visuospatial processing, and executive function. It will help to establish patients' mental status profile, including any deficits.
15938976|NCT03349411|Diagnostic Test|Montreal Cognitive Assessment|MoCA is a brief cognitive screening tool for individuals with mild cognitive impairment and will be used in the acute sample.
15938977|NCT03349411|Diagnostic Test|Geriatric Depression Scale|Because depression has been previously associated with delirium, patients will be evaluated for depression with the GDS. The GDS is a self-report measure consisting of 30 yes/no questions to measure depression in the elderly. It will be used as a covariate in data analysis.
15938978|NCT03349411|Diagnostic Test|Kessler Foundation Neglect Assessment Process|This is a 10-category scale for spatial neglect based on observation of activities of daily living (e.g., eating, dressing, grooming, gaze orientation). Thee test is based on the Catherine Bergego Scale (CBS) and administered via the standardized KF-Neglect Assessment Process developed within our program.
15938979|NCT03349398|Procedure|Uncut Roux-en-Y reconstruction|Uncut Roux-en-Y Reconstruction All surgical procedures will be performed by the single surgery team ,which is leaded by professor Wang Quan. Uncut Roux-en-Y construction will be used in this group.
15938980|NCT03349398|Procedure|Roux-en-Y reconstruction|Roux-en-Y Reconstruction All surgical procedures will be performed by the single surgery team ,which is leaded by professor Wang Quan. Roux-en-Y construction will be used in this group.
15938981|NCT03349372|Procedure|Hematopoietic stem cell transplantation|Hematopoietic stem cell transplantation
15938982|NCT03349359|Drug|HIV antiretroviral therapy|HIV patients are receiving an antiretroviral therapy according to the physician's discretion and the availability of drugs
15938983|NCT03349346|Drug|Idelalisib|Tablet (s) or dispersible tablets for suspension administered orally twice daily
15938984|NCT03349346|Drug|Rituximab|375 mg/m^2 administered intravenously
15938985|NCT03349346|Drug|Ifosfamide|3 mg/m^2 administered intravenously
15938986|NCT03349346|Drug|Carboplatin|635 mg/m^2 administered intravenously
15938987|NCT03349346|Drug|Etoposide|100 mg/m^2 administered intravenously
15938988|NCT03349333|Drug|pralatrexate|Pralatrexate will be administered at a dose of 30 mg/m2/week for 6 weeks followed by 1 week of rest in a 7-week cycle. Pralatrexate administration occurs once a week during week 1 through week 6 of each cycle.
15938989|NCT03349333|Dietary Supplement|Vitamin B12 and folic acid|The eligible subjects will receive vitamin supplementation at screening phase, at least 10 days prior to pralatrexate administration on cycle 1, dose 1. Vitamin supplementation will consist of vitamin B12 1 mg intramuscular (IM) q 8-10 weeks and folic acid 1.2mg by mouth (PO) once a day (QD). Once pralatrexate is permanently discontinued, vitamin supplementation should continue at least 1 month after the last pralatrexate dose, or longer at the discretion of the investigator.
15938990|NCT03349307|Device|Thin Convex Probe Endobronchial Ultrasound (TCP-EBUS)|Patients scheduled for a lobectomy will be recruited to this study and approached for informed consent. At the time of surgery, once the lobe has been removed, the TCP-EBUS will be inserted through a bronchial stamp for brief operability evaluations and image acquisition. Once this data has been captured standard of care will continue.
15938991|NCT03349281|Drug|Pevonedistat|Administered each cycle on days 1, 3 and 5.
15938992|NCT03349281|Drug|Vincristine|Administered each cycle on days 2, 9, 16 and 23.
15938993|NCT03349281|Drug|Dexamethasone|Taken orally each cycle on days 2 through 15.
15938994|NCT03349281|Drug|PEG-asparaginase|Administered via intramuscular injection (IM) each cycle on days 9 and 23.
15938995|NCT03349281|Drug|Doxorubicin|Administered via IV each cycle on day 2.
15938996|NCT03349281|Drug|Cytarabine|Administered to all subjects via IT injection on day 1; and on days 9, 16, and 23 to CNS positive subjects.
15938997|NCT03349281|Drug|Methotrexate|Administered via IT injection to CNS negative subjects on day 16; and to CNS positive subjects on days 9, 16 and 23.
15938998|NCT03349281|Drug|Hydrocortisone|Administered via IT injection to CNS positive subjects on days 9, 16, and 23.
15938999|NCT03349268|Device|Pulsed xenon ultraviolet (PX-UV) Device|"Two Detroit Medical Center (DMC) acute-care hospitals are being proposed for this project, Sinai-Grace Hospital (SGH) and Detroit Receiving Hospital (DRH). SGH is a 383-bed hospital, and DRH is a 248-bed hospital. The study will be conducted in eight hospital units in SGH and eight hospital units in DRH, including two medical intensive care units (ICUs), two surgical ICUs and 12 non-ICU medical-surgical wards. The 16 study units include a total of 379 beds.
~Devices will be deployed on these study units with the sham and intervention devices split evenly between SGH and DRH. Within each study site, the types of devices (PX-UV vs sham) will be assigned randomly to the units in Phase 1 and then switched in Phase 2."
15939043|NCT03348943|Behavioral|Left hemiparesis, left upper limb|Individuals with left hemiparesis Cerebral Palsy that will perform the tasks with the affected upper limb.
15939000|NCT03349268|Device|Sham Device|"Two Detroit Medical Center (DMC) acute-care hospitals are being proposed for this project, Sinai-Grace Hospital (SGH) and Detroit Receiving Hospital (DRH). SGH is a 383-bed hospital, and DRH is a 248-bed hospital. The study will be conducted in eight hospital units in SGH and eight hospital units in DRH, including two medical intensive care units (ICUs), two surgical ICUs and 12 non-ICU medical-surgical wards. The 16 study units include a total of 379 beds.
~Devices will be deployed on these study units with the sham and intervention devices split evenly between SGH and DRH. Within each study site, the types of devices (PX-UV vs sham) will be assigned randomly to the units in Phase 1 and then switched in Phase 2."
15939001|NCT03349255|Biological|autologous ET1402L1-CART cells|Autologous T cells transduced with lentivirus encoding an anti-AFP (ET1402L1)-CAR expression construct
15939002|NCT03349216|Procedure|Intravenous Regional Anesthesia|in this research patients will receive intravenous regional anesthesia as infusion of mini dose (that is 1.5 mg/kg ) lidocaine 0.5% and immediately after procedure their torniquettes (A.T.S. 2000, Zimmer, Inc., Bloomfield, CN) will be deflated (hence named Rapid MiniBier's block). the pain score will be assessed by NRS system before during and after the procedure.
15939003|NCT03349216|Drug|Systemic Analgesia|in this group the patients will receive ketamine 1-2 mg/kg IV slow ( Bioniche,Ireland Ketamine Hydrochloride 500mg/10cc)and titrated to effect. again here the pain score will be assessed before procedure and after the procedure every 5 minutes until 30 minutes by NRS ( Numerical Rating Score)
15939004|NCT03349203|Drug|Icotinib|Patients with EGFR-mutant stage IIIB or oligometastasis Non-small Cell Lung Cancer which can be potentially radical treated by surgery are arranged to receive Icotinib with a dose of 125 mg three times per day by mouth for 8 weeks as neoadjuvant therapy before surgery and 2 years as adjuvant therapy or till progressive disease or unaccepted toxicity.
15939005|NCT03349190|Drug|ULIPRISTAL ACETATE|Ulipristal Acetate (Esmya) administrated for fibroids indication before surgery and IVF/ICSI procedure(retrospective study)
15939006|NCT03349177|Drug|Epirubicin|100mg/m2
15939007|NCT03349177|Drug|Fluorouracil|500mg/m2
15939008|NCT03349177|Drug|Docetaxel|75mg/m2(TC), 100mg/m2(EC-T)
15939009|NCT03349177|Drug|Cyclophosphamide|500mg/m2(FEC), 600mg/m2(EC-T and TC)
15939010|NCT03349164|Diagnostic Test|acute PE survivors|Patients from this group will be assessed by cardiologist, echocardiography and VQ scanning
15939011|NCT03349151|Behavioral|Early feeding|Feeding on postoperative 2nd hour on return to the ward
15939012|NCT03349151|Behavioral|On- Demand feeding|Feeding whenever the patient asks for on return to the ward
15939013|NCT03349138|Device|Conventional Therapy|
15939014|NCT03349138|Device|Robotic Glove|
15939015|NCT03349138|Device|Electrical Stimulation|
15939016|NCT03349125|Behavioral|Collar On|
15939017|NCT03349125|Behavioral|Collar Off|
15939018|NCT03349112|Behavioral|4% Lidocaine Spray|2% Viscous Lidocaine is applied to the nares as standard of care. In this intervention, 4% lidocaine spray is applied additionally.
15939019|NCT03349112|Behavioral|2% Viscous Lidocaine|2% Viscous Lidocaine is applied to the nares as standard of care. This intervention is considered as the control group.
15939020|NCT03349099|Device|Cook Flexor|ureteral access sheath
15939021|NCT03349099|Device|Boston Scientific Navigator|ureteral access sheath
15939022|NCT03349086|Behavioral|Voice Exercise|Voice exercise will consist of sustained pitches and pitch glides on a variety of different vocal facilitators.
15939023|NCT03349073|Drug|T-1101 (Tosylate)|T-1101 (Tosylate) powder in bottle
15939024|NCT03349060|Drug|PF-04965842 100 mg|PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 12 weeks
15939025|NCT03349060|Drug|PF-04965842 200 mg|PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 12 weeks
15939026|NCT03349060|Drug|Placebo|Placebo, administered as two tablets to be taken orally once daily for 12 weeks
15939027|NCT03349047|Behavioral|Behavioral intervention group|Patients will hold the peanut or tree nut in a cup and will be asked to touch the nut with their finger.
15939028|NCT03349047|Behavioral|Education|The group will be educated about what can occur with contact with or being in proximity of peanuts or tree nuts.
15939029|NCT03349034|Drug|Ropivicaine|Patients will be randomized to receive a local continuous infusion of 6 ml/hr of 0.2% Ropivacaine via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
15939030|NCT03349034|Drug|Local Saline Infusion|Patients will be randomized to receive a local continuous infusion of 6 ml/hr of 0.9% normal saline via On-Q infusion pump, at the donor site, for the first 48 hours of the postoperative period.
15939031|NCT03349021|Device|Bougiecap|Treatment of esophagel Stenosis by Bougiecap
15939032|NCT03349008|Drug|Entecavir|Glycyrrhizin for the treatment of patients with chronic hepatitis B combined with entecavir-based
15939033|NCT03349008|Drug|Magnesium Isoglycyrrhizinate|Magnesium Isoglycyrrhizinate Injection treat for two weeks with entecavir-based
15939034|NCT03349008|Drug|Diammonium Glycyrrhizinate|Diammonium Glycyrrhizinate for oral after Magnesium Isoglycyrrhizinate Injection treatment with entecavir-based
15939035|NCT03349008|Drug|Magnesium Isoglycyrrhizinate Placebo|Magnesium Isoglycyrrhizinate Injection Placebo
15939036|NCT03349008|Drug|Diammonium Glycyrrhizinate Placebo|Diammonium Glycyrrhizinate Enteric-coated Capsules Placebo
15939038|NCT03348982|Behavioral|Jogging program|The intervention is a 12-week jogging program consisting of 24 sessions (two sessions per week, 30 min per session).
15939039|NCT03348969|Drug|Mitomycin c|Neoadjuvant Mitomycin C
15939040|NCT03348956|Diagnostic Test|EPR Oximetry|Subjects will have up to five EPR oximetry readings at each study visit. Subjects will place the foot with the paramagnetic ink injection between the two magnets of the EPR device. Continuous scans will be acquired for 10 minutes while the subject breathes room air, 10 minutes while the subject breathes enriched 100% oxygen, and 10 minutes while breathing room air again.
15939041|NCT03348943|Behavioral|Right hemiparesis, right upper limb.|Individuals with right hemiparesis Cerebral Palsy that will perform the tasks with the affected upper limb.
15939167|NCT03347981|Device|IOL implantation active comparator|Implantation of trifocal IOL POD F consisting of hydrophilic material
15939044|NCT03348943|Behavioral|Left hemiparesis, right upper limb|Individuals with left hemiparesis Cerebral Palsy that will perform the tasks with the non-affected upper limb.
15939045|NCT03348930|Drug|Tolcapone 200 MG|All eligible study subjects will go through a 2-week treatment phase during which they will begin tolcapone at 100mg twice a day.
15939046|NCT03348917|Drug|7.5% Povidone-Iodine [PVP-I]|Betadine® 7.5% skin cleanser (PVP-I 7.5%)
15939047|NCT03348917|Drug|4% chlorhexidine skin cleanser|Unity antiseptic hand wash (no alcohol)
15939048|NCT03348917|Drug|Plain non antibacterial soap|Guardian gel hand wash (not medicated),
15939049|NCT03348904|Drug|Nivolumab|Nivolumab administered intravenously at the protocol-defined dose every 3 weeks.
15939050|NCT03348904|Drug|Epacadostat|Epacadostat administered orally at the protocol-defined dose twice daily.
15939051|NCT03348904|Drug|Placebo|Matching placebo for epacadostat administered orally twice daily.
15939052|NCT03348904|Drug|Carboplatin|Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
15939053|NCT03348904|Drug|Cisplatin|Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
15939054|NCT03348904|Drug|Gemcitabine|Gemcitabine administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
15939055|NCT03348904|Drug|Paclitaxel|Paclitaxel administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles.
15939056|NCT03348904|Drug|Pemetrexed|Pemetrexed administered intravenously at the protocol-defined dose every 3 weeks for up to 4 cycles. Optional continuation maintenance every 3 weeks, if eligible.
15939057|NCT03348891|Other|Tumor biopsy specimens and blood samples|Tumor biopsy specimens (if feasible) and blood samples will be collected at Baseline, Week 6 Day 1 (blood sample only) and Week 12 Day 1.
15939058|NCT03348878|Other|assessment of drug compliance|assessment of drug compliance using electronic monitoring devices (2 months duration)
15939059|NCT03348865|Behavioral|Fertility Life Counselling Aid (FeLiCiA)|The FeLiCiA study is a pilot randomised control trial study of an intervention that uses cognitive behavioral therapy (CBT) method to provide counselling for infertility patients within low resource settings. this intervention is designed for management of the psychological problems associated with having infertility. It is based on the Thinking Healthy Programme by WHO.
15939060|NCT03348852|Device|Transcranial direct current stimulation|Device: Transcranial direct current stimulation Transcranial direct current stimulation over the motor cortex.
15939061|NCT03348839|Device|NeLLY service|Telesurveillance and therapeutic support
15939062|NCT03348826|Drug|Sodium Bicarbonate 8.4% Solution for Injection|3 mL injection into line with up to 2 injections administered
15939063|NCT03348826|Drug|Alteplase Injectable Solution|2 mL injection into line with up to 2 injections administered
15939064|NCT03348813|Behavioral|HIV/STI Prevention Intervention|The targeted HIV/STI risk reduction intervention was delivered with groups of up to 8 participants through 8, 45-minute modules equally divided over 2 days (4 modules per session). It was designed to enhance participants' knowledge and ability to reduce their risk of HIV/STIs. Grounded in both social/behavioral and cognitive theories, the intervention includes psychoeducation, and was intended to enhance participants' HIV/STI prevention knowledge, attitudes, beliefs and skills in a manner relevant to Black adolescents.
15939065|NCT03348813|Behavioral|General Health Control Intervention|"The original Promoting Health among Teens (PHAT) Project was designed to increase knowledge and motivation regarding healthful dietary practices, aerobic exercise, and breast and testicular self-examination, and to discourage cigarette smoking. The 8-hour, 2-session PHAT intervention was shortened to mirror the Project GOLD HIV/STI risk reduction curriculum. This was done to control for the Hawthorne effect and reduce the likelihood that effects of the HIV/STI risk reduction intervention can be attributed to its nonspecific features, including special attention. From an ethical standpoint, adolescents in both conditions received a valuable and engaging health-risk-reduction intervention as opposed to usual care."
15939066|NCT03348800|Procedure|Dental anesthesia|A tooth extraction will be performed
15939067|NCT03348787|Behavioral|Behavioral and Cognitive Therapies|"Group intervention of 6 weekly sessions of one hour and 30 minutes based on the psychoeducational therapeutic principles and CBT type 3 wave Accept Voices applied to HAV"
15939068|NCT03348761|Device|rTMS group|
15939069|NCT03348748|Other|Laboratory Biomarker Analysis|Correlative studies
15939070|NCT03348748|Other|Quality-of-Life Assessment|Ancillary studies
15939071|NCT03348748|Drug|Stereotactic Body Radiation Therapy|Undergo lowest-dose of SBRT
15939072|NCT03348748|Drug|Stereotactic Body Radiation Therapy|Undergo lowest- or higher-dose of SBRT
15939073|NCT03348748|Drug|Stereotactic Body Radiation Therapy|Undergo highest-dose of SBRT
15939074|NCT03348748|Procedure|Thoracic Surgical Procedure|Undergo thoracic surgery
15939075|NCT03348735|Drug|Lidocaine patch 5%|Application of Lidocaine 5% patch for 12 hours.
15939076|NCT03348735|Drug|Capsaicin 8% Patch|Application of Capsaicin 8% patch for
15939077|NCT03348735|Drug|Pregabalin|Oral treatment with pregabalin (75mg capsules) will be used at optimized doses to best match clinical practice in Europe.
15939078|NCT03348722|Other|Active surveillance|PSA testing (every 3 months, then every 6 after 30 months), clinical visit and DRE every 6 months, prostate biopsy after 1, 4 and 7 years
15939079|NCT03348722|Procedure|Radical prostatectomy|Radical prostatectomy (open, laparoscopic or robotic)
15939080|NCT03348722|Radiation|Radiotherapy|External radical radiotherapy or brachitherapy
15939081|NCT03348722|Procedure|Other radical treatments|High intensity focal ultrasound, cryotherapy, others
15939082|NCT03348709|Dietary Supplement|Isoosmolar|48 hours, 800 ml per 24 hours
15939083|NCT03348709|Dietary Supplement|Hyperosmolar|48 hours, 800 ml per 24 hours
15939084|NCT03348696|Drug|Dexamethasone tapering dose|dexamethasone standard of care pre-medication + dexamethasone tapering dose
15939085|NCT03348696|Drug|Dexamethasone physician choice|Dexamethasone standard of care pre-medication + dexamethasone physician choice
15939086|NCT03348683|Drug|Propranolol|After induction is started with Foley or misoprostol placement, 30 minutes will pass before administration of the one-time study medication, IV Propanolol.
15939087|NCT03348683|Drug|Placebo|After induction is started with Foley or misoprostol placement, 30 minutes will pass before administration of IV Saline
15939279|NCT03347097|Drug|TIL|
15939088|NCT03348670|Biological|COVID-19 Therapeutic Biologics - Spike-GM-CSF Protein Lactated Ringer's Injection|"Intradermic Injection, ID
~COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection"
15939089|NCT03348657|Other|Music Session|Three to four times a week, volunteer musicians came to the geriatric assessment unit and would provide music sessions (duration of about 60 minutes) to the patients who volunteered to attend.
15939090|NCT03348644|Dietary Supplement|Phosphate tablets.|
15939091|NCT03348644|Dietary Supplement|High cheese intake.|
15939092|NCT03348644|Dietary Supplement|High milk intake.|
15939095|NCT03348618|Biological|IVIG|Intravenous immunoglobulin
15939096|NCT03348605|Device|Phantom Stimulator, Cort X Sensorics, Spaichingen, Germany|"This system consists of a pressure sensing insole connected to regular TENS-Electrode patches which are applied to the receptive fields of the patients (evoking the sensation of heel and forefoot). The individually adjusted stimulation intensity on the systems regulatory box through a socked screw is set at the beginning of the testing phase, and not changed anymore.
~The current is applied to mimic the roll-off-sensation while walking. This is done by locating two sets of electrodes on the receptive fields representing the heel and the ball of the foot respectively. Now the current is applied in an alternating manner coordinated with the walking of the participant. The coordination is made able through the pressure sensing insole."
15939097|NCT03348592|Dietary Supplement|Oligofructose-enriched inulin (p-inulin)|
15939098|NCT03348592|Other|No treatment|Patients do not take a supplement during the first 8 weeks or the last 8 weeks of the study.
15939099|NCT03348579|Other|Guidelines publication and application|Passing recommendations on using the guidelines in the intensive care units
15939100|NCT03348579|Other|Targeted experience feedback|"Targeted experience feedback: On top of the standard training, the centers receive an analysis of the evolution of the practices of their center and the future of their patients between phases 1 and 2, as well as these same values for the data set. The centers are then called to conduct a meeting to determine their priority improvement points based on this audi"
15939101|NCT03348566|Other|fish|fish intkae
15939102|NCT03348553|Dietary Supplement|control group|no supplements given for 16 weeks, after 4 week washout of all supplements and dietetic products
15939103|NCT03348553|Dietary Supplement|Omega2|2 capsules of JP+® Omega/d for 16 weeks, after 4 week washout of all supplements and dietetic products
15939104|NCT03348553|Dietary Supplement|Omega4|4 capsules of JP+® Omega/d for 16 weeks, after 4 week washout of all supplements and dietetic products
15939105|NCT03348553|Dietary Supplement|Omega2+OGV|2 capsules of JP+® Omega/d plus 2 capsules each of an encapsulated fruit, vegetable and berry-juice concentrate (6 capsules) for 16 weeks, after 4 week washout of all supplements and dietetic products
15939106|NCT03348540|Behavioral|Attention Control Training|Attention control training teaches participants that the emotional salience of cues (i.e., threatening or neutral) is not related to successful completion of the computerized response task, and thus, teaches participants to ignore irrelevant threat-related contingencies (Badura-Brack et al., 2015).
15939107|NCT03348540|Behavioral|Comparison Task|Neutral- neutral stimuli prior to response task
15939108|NCT03348527|Drug|2-Hydroxyflutamide Depot|Liproca® Depot is a depot formulation containing a bioresorbable, controlled-release,formulation of the nonsteroidal antiandrogen 2-hydroxyflutamide
15939109|NCT03348514|Drug|CPX-POM|CPX-POM
15939110|NCT03348501|Other|survey for long-term follow-up of the disease|patients will be regularly asked about their state of health (occurrence of a major health event that required hospitalization, for example ...), and about their living conditions (alcohol and tobacco consumption, socio-economic environment). Questionnaires of quality of life and satisfaction related to care will also be offered at regular intervals to better know the impact of their disease on their daily lives and their perception of their care.
15939111|NCT03348488|Procedure|Ultrafiltration dose|Fixed high volume of ultrafiltration over an hour during dialysis
15939112|NCT03348475|Behavioral|Binge Focused Therapy (BFT) Intervention|The intervention, Binge Focused Therapy, is a 3-session, 8-week, non-expert guided self-help program. Participants will attend sessions at Week 1, Week 2, and Week 8 at the Nova Scotia Health Authority Eating Disorder Clinic. Each session will be approximately 2 hours in length.
15939113|NCT03348462|Drug|ethosomal preparation of anthralin|once daily with short contact topical application
15939114|NCT03348462|Drug|liposomal preparation of anthralin|once daily with short contact topical application
15939115|NCT03348449|Other|Collection of data|Outcome of patients will be collected from charts to evaluate primary and secondary objectives
15939116|NCT03348436|Procedure|radiofrequency ablation|
15939117|NCT03348423|Drug|DEX-IN|IN Dexmedetomidine + IV placebo
15939118|NCT03348423|Drug|Fentanyl|IN Placebo + IV Fentanyl
15939119|NCT03348423|Drug|Placebo|IN Placebo + IV Placebo
15939120|NCT03348410|Behavioral|Motivational interviewing|Motivational interviewing with insurance officer
15939121|NCT03348397|Procedure|right ventricular outflow tract reconstruction with contegra|Contegra pulmonary valved conduit is an animal jugular vein that contains a valve with three leaflets that are similar to a human heart valve.
15939122|NCT03348397|Procedure|right ventricular outflow tract reconstruction with pulmonary homograft|cryopreserved pulmonary homografts
15939123|NCT03348384|Radiation|[C-11]|Radiolabel
15939124|NCT03348384|Drug|NOP-1A|Tracer
15939125|NCT03348371|Other|Ethanol|The intervention is two different administrationforms of ethanol, orally and i.v.
15939126|NCT03348358|Behavioral|quiet music|playing quiet music during labor
15939127|NCT03348358|Behavioral|Rhythmic music|playing rhythmic music during labor
15939128|NCT03348358|Behavioral|control|No music during labor
15939129|NCT03348345|Behavioral|Eat Breathe Thrive|Eat Breathe Thrive (EBT) program which was designed to increase positive body image, awareness, self-regulation, and mindful eating habits. This program aims to achieve these things through psychoeducation of cultural influences of beauty standards, the basic neuropsychological systems in the body and how they affect eating habits, creating a community within the group members for support, and finally through the practice of yoga.
15939168|NCT03347968|Biological|MEDI0382|All participants will receive MEDI0382
15939130|NCT03348332|Behavioral|Exercise pregnant women|A supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 10 to 39) was conducted. Each session consisted of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training. Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60 of maximal heart rate. All subjects wore a heart rate (HR) monitor during the training sessions to control the intensity.
15939131|NCT03348319|Other|radiation|Scanning cadaver organs
15939132|NCT03348306|Device|MRI|Brain and cardiac MRI in one time with gadolinium injection.
15939133|NCT03348306|Biological|Blood sample collection|A blood sampling is also collected for hematocrit measure.
15939134|NCT03348293|Procedure|3D printing|Scope of tumor resection was simulated according to the MR imaging data. After meticulous design, we created the personalized porous biodegradable scaffold and printed by 3D printer, using porous PCL biomaterials. During operation, the biodegradable scaffold was implanted into the defective cavity after tumor resection.
15939135|NCT03348280|Diagnostic Test|Blood draw|Blood will be drawn to isolate monocytes after 2 weeks off of blood pressure lowering medications.
15939136|NCT03348267|Dietary Supplement|Milk protein isolate|Milk protein isolate in a powder form consisted of 80% casein and 20% whey protein. 20g were diluted into 500 ml water
15939137|NCT03348267|Dietary Supplement|Placebo|500 mL drink that contained water (375 mL), sugar-free cordial (125 mL) and 2 g of low-calorie glucose/dextrose powder.
15939138|NCT03348254|Drug|Single shot antibiotic prophylaxis|single shot preoperative antibiotic prophylaxis
15939139|NCT03348254|Drug|Multiple shot antibiotic prophylaxis|Multiple shot perioperative antibiotic prophylaxis
15939140|NCT03348241|Drug|Gum Arabic|Gum acacia, also known as Gum Arabic is exuded from acacia trees; mainly from Acacia Senegal (gum Hashab or Kordofan gum) which was used in this study.
15939141|NCT03348241|Drug|Chemotherapy|Patients of control group and study group (Gum Arabic group) received chemotherapy according to type and stage of cancer.
15939142|NCT03348241|Behavioral|Lifestyle counseling|Lifestyle counseling pertaining to the optimal nutrition and daily routine for oral hygiene.
15939143|NCT03348228|Dietary Supplement|Hydroxycitrate (HCA)|Hydroxycitrate supplements are available over the counter and are primarily promoted as a weight loss supplement. Each subject will be given 42 capsules of Swanson super citrimax (hydroxycitrate) Details of the product are provided above. The subjects will be asked to take the capsules over a seven period (6 capsules per day).
15939144|NCT03348215|Other|Enhanced Treadmill Training|6 week programme of treadmill training with addition of an immersive environment (virtual reality projection), body weight support, orthotics and functional electrical stimulation
15939145|NCT03348189|Other|Pulse Oximeter|Pulse Oximeter
15939146|NCT03348176|Other|Vegetable exposure|Repeated exposure to variety of vegetables
15939147|NCT03348176|Behavioral|VIPP-Feeding Infants|Promoting responsive feeding practices
15939148|NCT03348176|Other|Control|Phone calls with mother about development of child, no advice on complementary feeding
15939149|NCT03348163|Drug|B/FTC/TAF|B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
15939150|NCT03348163|Drug|Current ART|Comparator arm. Participant continues open label entry ART.
15939151|NCT03348150|Procedure|Cytoreductive surgery + Gastrecomy|Complete cytoreduction followed by a (sub)total gastric resection with D2 lymphadenectomy.
15939152|NCT03348150|Drug|Hyperthermic Intraperitoneal Chemotherapy (HIPEC)|HIPEC: perfusion with oxaliplatin (460mg/m2 ) (42 °C) followed by docetaxel (50mg/m2 ) (37°C)
15939153|NCT03348137|Other|Questionnaire Administration|Ancillary studies
15939154|NCT03348124|Behavioral|"Children - what does it involve?"|"Thirteen educational lessons based on the conversational material Toolkit will be delivered in the classroom at school, two lessons per theme. The themes consists of: 1) a card game: What i wish 2) Time 3) Money 4) Skills 5) Relations 6) Housing. The material is prepared and same for all schools. This intervention will be given 1-2 lessons per week over a period of 8-14 weeks. During this period the students also care for the RCB simulator during three days and nights, but with a break for day care for the simulator which was between 7 am and 5 pm when the students were in school. All students will practice handling the simulator to be familiar with all types of needs: to rock, change diaper, feed and burp and were taught the skills of head support, techniques to avoid rough handling."
15939155|NCT03348111|Device|Air-polishing device|Air abrasion using the Air-Flow Master Piezon® with erythritol and Chlorhexidine powders on implants presenting clinical and radiographic signs of mucositis and peri-implantitis along with renewal of local oral hygiene instructions in order to reduce the inflammation locally
15939156|NCT03348098|Drug|Apatinib|500 mg, po, qd. 12weeks
15939157|NCT03348098|Drug|Paclitaxel|drug: Paclitaxel ,80mg/m2, d1, Once a week , A total of 12 weeks; 3 weeks as a cycle
15939158|NCT03348085|Other|No intervention|No intervention.
15939159|NCT03348072|Procedure|Cardiac surgery|Cardiac surgery
15939160|NCT03348059|Drug|Direct-acting antiviral therapy|HCV patients received direct-acting antiviral treatment for 12 or 24 weeks
15939161|NCT03348046|Drug|Biosimilar Infliximab|A vial containing powder for concentrate for solution for infusion. Each vial contains: Infliximab 100 mg
15939162|NCT03348033|Biological|Chronic Myeloid Leukemia + NK cell|Patients with chronic phase chronic myeloid leukemia who lost response to the second line of treatment with tyrosine kinase inhibitor with indication of bone marrow transplantation or refractory. Infusion of autologous natural killer cells, expanded in the laboratory, after chemotherapeutic conditioning.
15939163|NCT03348020|Procedure|Blood Donation|Subjects will donate blood within ~1 month after their baseline clinical trial. Subjects will report to the Substrate Metabolism Laboratory between 24 and 72 hours following blood donation. A finger-stick will be performed for the measurement of hemoglobin concentration.
15939164|NCT03348007|Other|Taking two kinds of mineral water|1.5L of low-mineral water (Vittel Bonne Source, control group) or 1L of Hépar + 0.5L of low-mineral water (Hépar group).
15939165|NCT03347994|Drug|Minnelide|Minnelide therapy may be administered for up to 12 cycles of 28 days are planned. If patients are receiving clinical benefit, treatment can continue beyond 12 cycles.
15939166|NCT03347981|Device|IOL implantation experimental|Implantation of trifocal IOL POD F GF consisting of hydrophobic material
15939169|NCT03347968|Drug|Warfarin|All participants will receive Warfarin
15939171|NCT03347955|Procedure|Neural implantation group|Cultured mesencephalic tissue from four embryos was implanted into the putamen bilaterally for those receiving the implant
15939172|NCT03347955|Procedure|Sham surgery|Steel frame affixed to head and four burr holes drilled into forehead of sham surgery patients
15939173|NCT03347942|Behavioral|Intervention group|Wait at least 20 minutes after finishing the first portion of meals previously considered sufficient by the individual before serving again if he or she feels the need. The intervention time will be monitored by the participants themselves, who will be instructed by the researcher when the methodology to be performed.
15939174|NCT03347942|Other|Control group|The control group will also serve the dish of the form, but can serve additional portion without waiting.
15939175|NCT03347929|Drug|Naproxen 500 Mg|10 days treatment with Naproxen 500 mg twice daily
15939176|NCT03347929|Drug|Placebo|10 days treatment with Placebo1 tablet twice daily
15939177|NCT03347916|Drug|Strawberry juice as (placebo)|Patients received strawberry juice 5 ml volume, one hour before induction.
15939178|NCT03347916|Drug|Gabapentin Oral Solution [Neurontin]|Patients received gabapentin (Neurontin oral solution 250 mg/ml, Pfizer, USA) 5 mg/kg mixed with strawberry juice to constitute 5 ml volume, one hour before induction.
15939179|NCT03347890|Drug|Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml or Placebo|Patients will be evaluated at baseline and at 16-week (end of study) after daily subcutaneous injections of Saxenda® (liraglutide 3.0 mg) or Placebo by pen injector.
15939180|NCT03347877|Procedure|autologous osteo-periosteal cylinder graft transplantation|Autologous osteo-periosteal cylinder graft transplantation is a novel treatment for Hepple V osteochondral lesions of the talus.
15939181|NCT03347877|Procedure|autologous osteochondral graft transplantation|Autologous osteochondral graft transplantation is the most common treatment for Hepple V osteochondral lesions of the talus.
15939182|NCT03347877|Device|autologous osteo-periosteal cylinder graft|Autologous osteo-periosteal cylinder graft is taken from ilium.
15939183|NCT03347864|Drug|68Ga-NOTA-RM26|1.85 MBq per kilogram body weight of 68Ga-NOTA-RM26 were injected into the patients before the PET/CT scans
15939184|NCT03347851|Other|MRI|Enrolled patients will complete a non-contrast cardiac MRI
15939185|NCT03347851|Other|Transthoracic echocardiography exam|Enrolled patients will complete a transthoracic echocardiography exam.
15939186|NCT03347838|Drug|Nivolumab|Nivolumab is a human monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
15939187|NCT03347825|Procedure|Robotic-assisted lobectomy using da Vinci Surgical System|Robotic-assisted lobectomy
15939188|NCT03347825|Procedure|VATS (video assisted thoracic surgery)|VATS (video assisted thoracic surgery)
15939189|NCT03347825|Procedure|Open lobectomy|Open lobectomy
15939190|NCT03347812|Procedure|Endovascular Aortic Repair|Without surgery to expose the lesion directly, minimal invasive treatment for the aortic arch lesion under the guidance of imaging equipment is performed through the blood vessel with a tiny wound of a few centimeters, in our research, including chimney, branch stent-grafts and fenestration techniques.
15939191|NCT03347812|Procedure|Total Arch Replacement|A kind of open surgery is performed for the replacement of total aortic arch.
15939192|NCT03347786|Drug|Verapamil|Intra-arterial delivery of verapamil following mechanical thrombectomy procedure
15939193|NCT03347773|Dietary Supplement|ReGen 18%|ReGen 18% is a kind of oral nutritional supplement, designed for patients under regular hemodialysis. One can of ReGen 18% contains 237ml, 425 Kcal, 19.1g protein, 22.7g lipid and 37.9g carbohydrate.
15939194|NCT03347760|Drug|DOTATOC-68Ga PET initial|DOTATOC is a tracer of high affinity for the type 2 somatostatin receptors and is used for imaging of tumours which are expressing them, including endocrine tumours
15939195|NCT03347760|Drug|DOTATOC-68Ga PET at 6 months|DOTATOC is a tracer of high affinity for the type 2 somatostatin receptors and is used for imaging of tumours which are expressing them, including endocrine tumours
15939196|NCT03347760|Biological|blood sample|blood tests will be carried out during the control visit to ensure that biological parameters are normalized
15939197|NCT03347747|Other|Study Photography + Personal & Medical History Collection|3D facial images taken and complete a detailed study questionnaire
15939198|NCT03347734|Behavioral|Eye exercises group|"20 times hot water, 20 times cold water washing face in the morning and evening.
~Palming; 2 hands are rubbed together and warmed up, and the eyes are closed, and 8 digits are drawn with eyes in darkness.
~20 blinks
~Looking at a clock in a circular shape, from 12 to 6, from 6 to 12, from 3 to 9, from 9 to 3, from 2 to 8, from 8 to 2, oblique from 10 to 4, from 4 to 10, and turning the eyes starting from 12 clockwise and counterclockwise. At the end of the exercises, 2-3 minutes of light massage around the eyes and on sunny days, sunbathing was recommended by closing the eyes for 3-5 minutes and swinging to the left and right."
15939199|NCT03347734|Behavioral|Convergence exercise group|"Close eyes for 15 s,
~Focus on a point 1 to 1.5 ft away for 10 s,
~Close eyes for 5 s,
~Focus on a point 20 ft away for 10 s,
~Close eyes for 5 s,
~Focus on a point 1 to 1.5 ft away for 10 s,
~Blink for 5 s,
~Close eyes for 5 s."
15939200|NCT03347734|Behavioral|Oculomotor Exercise Group (OMEG)|"The saccadic eye movement exercise included moving the eyes horizontally between two stationary targets while keeping the head still.
~The smooth pursuit exercise included moving the target horizontally and tracking it with the eyes while keeping the head still.
~The adaptation X1 exercise included moving the head horizontally while keeping the stationary target in focus.
~The adaptation X2 exercise included moving the head and target in opposite directions horizontally while tracking the target with the eyes."
15939201|NCT03347721|Drug|lidocaine gel|2% lidocaine jelly, injected into the urethra
15939202|NCT03347721|Drug|Lubricant Gel|Lubricating gel
15939203|NCT03347708|Biological|IDCT|Discogenic Cells + Sodium Hyaluronate Vehicle
15939204|NCT03347708|Drug|Saline Solution|Sodium Chloride Solution
15939205|NCT03347708|Drug|Sodium Hyaluronate|Sodium Hyaluronate Vehicle
15939208|NCT03347682|Other|Satisfaction with Prosthesis -SATPRO|questionnaire 1
15939209|NCT03347682|Other|Nottingham Health Profile-NHP|questionnaire 2
15939210|NCT03347682|Other|Prosthesis donning and doffing questionnaire|questionnaire 3
15939211|NCT03347669|Device|Sudoscan®|Sudoscan® is a new device that provides rapid, non-invasive and reproducible quantitative assessment of sweat function. It makes it possible to measure the ability of the sweat glands to release chloride ions in response to electrochemical activation and thus to detect the presence of a neuropathy with small fibers. This new device therefore makes it possible to detect an SFN in a much simpler and faster way than the technique of ophthalmology, or biopsy. Sudoscan® has been tested to assess the neuropathies of small nerve fibers in several diseases, in particular diabetes, chemotherapy-induced polyneuropathy, familial amyloid polyneuropathy or Fabry disease. The interest of Sudoscan® lies in the fact that this device is non-invasive and rapid. Its diagnostic value has been compared with other neurophysiological tests.
15939212|NCT03347643|Device|tDCS with real stimulation|tDCS is a non-invasive brain stimulation. Real stimulation includes 2mA current for 20 minutes per session. Two sessions a day for 5 consecutive days (Total: 10 sessions) will be applied.
15939213|NCT03347643|Device|tDCS with sham stimulation|Sham stimulation includes 0mA current for 20 minutes per session. Two sessions a day for 5 consecutive days (Total: 10 sessions) will be applied.
15939214|NCT03347630|Diagnostic Test|MRI|Thoraco-abominal MRI
15939215|NCT03347617|Drug|Ferumoxytol|Given IV
15939216|NCT03347617|Other|Laboratory Biomarker Analysis|Correlative studies
15939217|NCT03347617|Procedure|Magnetic Resonance Imaging|Undergo ferumoxytol MRI
15939218|NCT03347617|Biological|Pembrolizumab|Given IV
15939219|NCT03347604|Diagnostic Test|Supine spirometry, MIPs and MEPs|We are going to test spirometry while in supine position , and also test respiratory muscles by measuring the maximum inspiratory and maximum expiratory efforts made by patients.
15939220|NCT03347591|Genetic|WES|136 bleeding related OMIM (Online Mendelian Inheritance in Man)-proved genes involved in haemostasis will be selected from Whole Exome Sequencing (WES)
15939221|NCT03347591|Diagnostic Test|Several assays|Patients will be approached by their own treating physician. Data will be collected through questionnaires, a clinical interview, a blood and saliva sample obtained from each participant, and thorough review of electronic patient records. All procedures are study related. In case a physician visit with the treating physician is already planned, or in case a venepuncture for regular diagnostics or treatment is already planned, this can be combined with the study procedures to prevent an extra visit.
15939222|NCT03347578|Diagnostic Test|Ultrasonography|Diaphragmatic ultrasound was performed to investigate diaphragmatic function after thoracic surgery
15939223|NCT03347552|Behavioral|HOME|"Prior to discharge from the inpatient unit, the HOME program provider or another member of the research team, will meet individually with the Veteran to provide further information regarding the HOME program intervention. Efforts are made to schedule the initial phone call and home visit that occur during the first week after discharge. Following the home visit, the HOME provider may continue to have weekly contact with the Veteran via the telephone or in person until he or she is disenrolled following engagement in outpatient care. Engaged in care is defined as attendance at two individual outpatient mental health appointments or engagement in equivalent or elevated care as determined by the PI. All clinical contacts with the Veteran may include the following: suicide risk assessment, review and modification of the Veteran's safety plan, review and modification of the discharge plan, involvement of the Veteran's support system, and facilitation of engagement in outpatient care."
15939224|NCT03347539|Device|Nexplaon|This study is an exploratory study of user reasons for Nexplanon implant and removal, and NOT a study on the efficacy or safety of Nexplanon. Nexplanon has already been FDA approved and its efficacy and safety studied.
15939225|NCT03347526|Drug|Cosyntropin Injectable Suspension, 1 mg/mL|Injectable
15939226|NCT03347526|Drug|Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin|Injectable + oral solution
15939227|NCT03347526|Drug|Vigabatrin|oral
15939228|NCT03347513|Drug|triple attack therapy|eradication of H-pylori using triple attack therapy.
15939229|NCT03347513|Drug|Ferrous(II)-glycine-sulphate complex 567.7 mg capsules|Iron therapy will be given to both groups twice daily for one month.
15939230|NCT03347500|Other|use of patient-derived biological samples|We will use biological samples that are routinely collected as waste material from patients undergoing prosthetic surgery at IRCCS Istituto Ortopedico Galeazzi. Peripheral blood will be also collected from patients during the pre-surgery visit and during the post-surgery hospitalization coinciding with routine blood sample collection.
15939231|NCT03347487|Procedure|Deep brain stimuation system implantation|All subjects will receive bilateral surgical implantation of DBS system.The Medtronic DBS 3389 electrode is utilized in this study. The DBS system includes a dual-channel neurostimulator kit, lead kit, extension kit, clinician-operated wireless programmer, test stimulator, and patient controller.
15939232|NCT03347474|Procedure|Bilateral surgical implantation of DBS system to NAc|The Medtronic, PINS and SceneRay DBS device will be utilized in the present study.
15939233|NCT03347461|Drug|Otiprio|Otiprio is a single-dose, physician-administered, sustained-exposure otic fluoroquinolone antibacterial for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement surgery. Otoprio (6% ciprofloxacin, 60 mg/mL) will be administered through the tube lumen by the otolaryngologist immediately after tympanostomy surgery.
15939234|NCT03347461|Drug|Ciprodex|Ciprodex is a combined antibiotic and steroid ear drop used to treat otitis media with tympanostomy tubes. Four drops of Ciprodex (0.14mL) instilled by the otolaryngologist into the affected ear immediately after tympanostomy surgery. Each mL of Ciprodex contains ciprofloxacin hydrochloride 0.3 % (equivalent to 3 mg ciprofloxacin base) and dexamethasone 0.1 % equivalent to 1 mg dexamethasone
15939280|NCT03347097|Drug|PD1-TIL|
15939235|NCT03347435|Genetic|genetic tests for CYP2C19*2, CYP2C19*17 and ABCB1 3435|The CYP2C19*2 (10q24.1-q24.3; rs4244285), CYP2C19*17 (10q24.1-q24.3; rs12248560) and ABCB1 3435 (7q21.1; rs1045642) genetic variants will be genotyped using an ST Q3 system. The conventional genotyping methods so far used for diagnostic purposes will not be used in this study because appropriate labs may not be readily available and the processing time is prohibitive. Q3 is a compact platform enabling the classical laboratory analysis of DNA by means of real-time PCR. The Q3 has been designed as a low entry-cost, portable, point-of-care instrument for foolproof use by unskilled personnel. Antiplatelet therapy will be choose on the basis of clinical and genetic algorithm.
15939236|NCT03347435|Other|clinical algorithm|Antiplatelet therapy will be choose on the basis of clinical algorithm alone
15939237|NCT03347422|Drug|sutimlimab (BIVV009)|Pharmaceutical form:solution for injection Route of administration: intravenous(i.v.)
15939238|NCT03347422|Drug|placebo|Pharmaceutical form:solution for injection Route of administration: intravenous(i.v.)
15939239|NCT03347409|Other|Changes in preoperative care|Optimization of relevant medical uncontrolled situations, avoid fasting, avoid bowel preparation, avoid premedications, nutritional assessment, stop smoking, stop alcohol and appropriate counselling
15939240|NCT03347409|Other|Changes in intraoperative care|Blended anesthesia is mostly carried out using Total Intra Venous Anesthesia (TIVA) with loco regional analgesia, in particular Thoracic Epidural Anesthesia (TEA) in open surgery and spinal morphine or Transversus Abdominis Plane (TAP) block or quadratus lumborum block for laparoscopic surgical approach, associated to NSAIDs or acetaminophen; control of deep neuromuscular blocking with Train-of-four (TOF) stimulation avoiding residual paralysis. Multimodal prevention of PONV (according to preoperative assessment of Apfel Score) with a combination of multiple antiemetic drugs.
15939241|NCT03347409|Other|Changes in postoperative care|Postoperative pain control is obtained with opioid sparing strategies, in order to avoid Post Operative Ileus (POI) and PONV. According to the type of surgery TEA, TAP block , quadratus lumborum block or IT morphine is preferred. Patient is proposed to start drinking clear fluid 4 hours after surgery and to start eating the evening of the surgery, with the introduction of a normal free diet within 24 hours after surgery. It is proposed to chew gum three times daily for at least 15 minutes and eventually to use laxatives to promote a faster bowel function. Early mobilization is started from the evening of surgery.
15939242|NCT03347396|Drug|Sutimlimab|Sutimlimab will be administered as IV infusion.
15939243|NCT03347383|Device|Combination therapy DCB + stent|Patients will be treated with the Luminor DCB and iVolution stent
15939244|NCT03347370|Drug|SC Peginterferon beta-1a|All participants will be treated with their current SC interferon beta medication according to the Fachinformation (German equivalent to summary of product characteristics [SmPC]).
15939245|NCT03347370|Drug|SC interferon beta-1a|All participants will be treated with their current SC interferon beta medication according to the Fachinformation (German equivalent to summary of product characteristics [SmPC]).
15939246|NCT03347370|Drug|SC interferon beta-1b|All participants will be treated with their current SC interferon beta medication according to the Fachinformation (German equivalent to summary of product.
15939247|NCT03347357|Drug|Tacrolimus|Tacrolimus was administered orally at a dose of 0.05 mg/kg/dose twice daily (bid) for children with nephrotic syndrome.
15939248|NCT03347344|Drug|Riluzole|50 mg will be administered (per os) twice a day
15939249|NCT03347344|Drug|Placebo|50 mg will be administered (per os) twice a day
15939250|NCT03347331|Drug|[18F]F13640|"Radiotracer injection and PET scan acquisition of 90 min:
~*150 Mbq + 1 MBq/Kg of [18F]F13640 at t=0 min
~Arterial Blood Sampling during the 90min acquisition"
15939251|NCT03347331|Drug|[18F]F13640|2 Radiotracer injections and PET scan acquisition of 90 min distant from 1 to 3 weeks: For each exam: 150 MBq + 1 MBq/kg of [18F]F13640 at t=0 min
15939252|NCT03347305|Behavioral|automated DP|Energy expenditure measurement
15939253|NCT03347305|Behavioral|Calorimetric chamber|The main objective is to compare DE and its variations according to the conditions (rest, sleep, meals, physical activity) in patients treated with automated DP compared to controls, in a calorimetric chamber
15939254|NCT03347292|Drug|Regorafenib(Stivarga, BAY73-4506)|Regorafenib 80mg/120mg/160mg q.d., 3 weeks on / 1 week off + pembrolizumab 200mg i.v. every 3 weeks
15939255|NCT03347292|Drug|Pembrolizumab|200 mg i.v.(Intravenous(ly)) every 3 weeks (Q3W). This dose will not be escalated or deescalated and the dosing schedule will not be changed
15939256|NCT03347279|Biological|Experimental: Tezepelumab|Tezepelumab subcutaneous injection
15939257|NCT03347279|Other|Placebo|Placebo subcutaneous injection
15939258|NCT03347266|Drug|VVZ-149 injections|•VVZ-149 injection
15939259|NCT03347266|Drug|Placebo|water for injection
15939260|NCT03347240|Procedure|Brain Lesioning|Stereotactic radiofrequency lesioning of the pallidum or thalamus
15939261|NCT03347240|Procedure|Combined anterior and posterior lumbosacral rhizotomy|Combined anterior and posterior lumbosacral rhizotomy
15939262|NCT03347240|Device|Deep brain stimulation|Bilateral DBS
15939263|NCT03347240|Device|Intra-thecal baclofen infusion|Intra-thecal Baclofen infusion
15939264|NCT03347227|Procedure|Catheter ablation|Wide area circumferential catheter ablation for pulmonary vein isolation of persistent atrial fibrillation
15939265|NCT03347201|Device|HMS Plus|Subjects randomized to the intervention group will have their dose of Heparin and Protamine calculated by the HMS Plus.
15939266|NCT03347188|Drug|Fremanezumab|Fremanezumab will be administered per dose and schedule specified in the arm.
15939267|NCT03347188|Drug|Placebo|Placebo matching to fremanezumab will be administered per schedule specified in the arm.
15939268|NCT03347175|Procedure|Volume controlled ventilation|Volume controlled ventilation mode
15939269|NCT03347175|Procedure|Pressure controlled ventilation|Pressure controlled ventilation
15939270|NCT03347175|Procedure|CPAP mode|CPAP mode only
15939271|NCT03347149|Device|Alarm Advisor Software|Providing advice on alarm limits as part of routine medical care
15939272|NCT03347136|Device|CPAP|
15939273|NCT03347136|Device|NIPPV|
15939274|NCT03347123|Drug|Epacadostat|Phase 1: Epacadostat at the protocol-defined dose twice daily. Phase 2: Epacadostat at the recommended dose from Phase 1.
15939275|NCT03347123|Drug|Nivolumab|Nivolumab at the protocol-specified dose and schedule.
15939276|NCT03347123|Drug|Ipilimumab|Ipilimumab at the protocol-specified dose and schedule.
15939281|NCT03347084|Device|Excitation|Administration of LIFUP, a method of deep brain stimulation, according to excitation paradigms using the following parameters: Tone Burst Duration = 50ms; Pulse Repetition Frequency = 10Hz; ISPTA = 720 mW/cm2. Four treatments of thirty seconds each, with two-minute intervals between treatment (20 minutes, approximately)
15939282|NCT03347084|Device|Inhibition|Administration of LIFUP, a method of deep brain stimulation, according to inhibition paradigms using the following parameters: Tone Burst Duration = 50ms and Pulse Repetition Frequency = 10Hz. Four treatments of thirty seconds each, with two-minute intervals between treatment (20 minutes, approximately)
15939283|NCT03347071|Behavioral|Prevention Course Group|The undergraduate prevention course is structured around Eat Breathe Thrive Program curriculum. The course aims to teach somatic practices, provide healthy tools for emotional regulation, allow for the creation of community-based networks of support, foster a sense of meaning and purpose through service activities, and practice these learned skills through yoga.
15939284|NCT03347058|Other|Supportive programming|Access to a suite of resources, including digital tools, person-to-person support, and educational resources
15939285|NCT03347045|Combination Product|Trimodal Prehab & ERP|"1-hr daily exercise will be completed a total of 5d/week, of which 2 of these sessions are completed through a community fitness center. Following these sessions, the participant will consume a high-protein oral supplement.
~Additionally, during the program, participants will be given the option of attending a stress-reduction group and will receive a take-home anxiety-reduction program. They will have access to a physiotherapist, kinesiologist, registered dietitian, and physician throughout the program.
~The total length of this program is 8-weeks and is timed to occur in the waiting period between the consent for surgery and operation date."
15939286|NCT03347045|Other|No Prehab; ERP Alone|1-hr daily exercise with a self-completed home-exercise program. The participant will be given nutritional education material and a take-home anxiety-reduction program. They will be responsible for maintaining a journal of their activity.
15939287|NCT03347032|Procedure|Remote ischemic preconditioning|Serial inflations and deflations as detailed in the arm/group descriptions
15939288|NCT03347032|Procedure|Control|Serial inflations and deflations as detailed in the arm/group descriptions
15939289|NCT03347019|Other|Accelerated rehabilitation|advances in arthroscopic surgery have resulted in biomechanically stronger repairs that might allow for accelerated rehabilitation protocols and hence faster return to daily living activities and scapular control
15939290|NCT03347019|Other|Delayed rehabilitation|Patients were not allowed to start rehabilitation programme first three weeks after surgery.
15939291|NCT03347006|Dietary Supplement|SPM Active|"Supplement or placebo will be administered orally between 9 am to 9:30 am.
~Each participant will give a baseline blood sample then they will be given one of the randomly allocated three doses of fish oil supplement, or a matching placebo in one of 8 study groups [this will be on a 1:1:1:1:1:1:1:1 ratio]. Blood will be collected again at 2h, 4h, 6h and 24h after supplementation/placebo, 12ml per time interval."
15939292|NCT03346993|Drug|Bupivacaine Hydrochloride 5 MG/ML|Ultrasound guided infraclavicular brachial plexus block with warmed bupivacaine
15939293|NCT03346980|Diagnostic Test|Esophagogastroduodenoscopy|All patients will be evaluated with both standard HD gastroscope and side-viewing duodenoscope; the latter to ensure proper visualization of the major papilla.
15939294|NCT03346967|Combination Product|adipose-derived mesenchymal stem cells|Collect adipose-derived mesenchymal stem cells from the patients. Adipose-derived mesenchymal stem cells will be isolated, expanded and characterized in vitro under the GMP- grade procedure
15939295|NCT03346954|Other|[11C]-Methionine PET/MRI|Implementation [11C]-Methionine PET/MRI performed for each patient in one place (department of nuclear medicine of the Hospices Civils de Lyon). The [11C]-Methionine PET/MRI will be performed after a pituitary MRI and before a transsphenoidal surgery.
15939296|NCT03346941|Drug|DAA treatment|Direct-acting antiviral-based treatment
15939297|NCT03346928|Procedure|Head and neck reconstruction|Head and neck free flap reconstruction
15939298|NCT03346915|Behavioral|WoW and BNI|The Text/web based health information technology system, WoW, will provide educational resources for participants and their families to learn more about HPV vaccination and cervical cancer screening. WoW will be tailored to the participant and will be based on the participant's cancer screening and HPV vaccine health needs; It will then send custom text messages based their concerns and will remind them to schedule and attend their doctor's appointment. The brief negotiated interview will encourage and empower participants to have positive behavioral changes in regards to their health.
15939299|NCT03346902|Drug|EB-001|Injection of EB-001 into area of scarring (forehead)
15939300|NCT03346902|Drug|0.9% Sodium Chloride Injection|Injection of Saline into area of scarring (forehead)
15939301|NCT03346876|Procedure|Nuss surgery|surgical correction for pectus excacatum
15939302|NCT03346850|Device|Nasogastric tube (NGT) feeding|A nasogastric tube goes from the nose to the stomach.
15939303|NCT03346850|Device|Nasoduodenal tube (NDT) feeding|A nasoduodenal tube goes from the nose to the duodenum.
15939304|NCT03346837|Drug|BMS-986205|BMS-986205
15939305|NCT03346837|Drug|Itraconazole|Oral solution
15939306|NCT03346837|Drug|Rifampin|Tablet
15939307|NCT03346811|Drug|Icotinib|Patients with plasma EGFR mutation-positive are arranged to receive icotinib with a dose of 125 mg three times per day, till progressive disease or unaccepted toxicity
15939308|NCT03346798|Behavioral|Food Photography|Participants will engage in food photography on their smart phones while eating
15939309|NCT03346798|Behavioral|Non-Food Photography|Participants will engage in non-food photography on their smart phones while eating
15939310|NCT03346798|Behavioral|No Phone Use|Participants will not use their smart phones while eating
15939311|NCT03346785|Behavioral|Food Photography|Participants will engage in food photography on their smart phones while eating
15939312|NCT03346785|Behavioral|Non-Food Photography|Participants will engage in non-food photography on their smart phones while eating
15939313|NCT03346785|Behavioral|No Phone Use|Participants will not use their smart phones while eating
15939314|NCT03346772|Biological|Influenza vaccination|Adults will receive one intramuscular dose of seasonal quadrivalent inactivated influenza vaccine, as indicated for standard of care.
15939315|NCT03346759|Device|Tampon A|24 Tampax Pearl Regular Tampons for use during a single menstrual period.
15976545|NCT03063034|Other|PD21864AB|A king size menthol cigarette.
15939316|NCT03346759|Device|Tampon B|24 Playtex Gentle Glide 360 Regular Tampons for use during a single menstrual period.
15939317|NCT03346746|Dietary Supplement|Low Glycaemic Diet|This intervention was a diet that provided participants with three meals with a low GI value. These meals were breakfast (9am), lunch (midday) and a snack (3pm).
15939318|NCT03346746|Dietary Supplement|High Glycaemic Diet|This intervention was a diet that provided participants with three meals with a high GI value. These meals were breakfast (9am), lunch (midday) and a snack (3pm).
15939319|NCT03346733|Dietary Supplement|Psyllium Fibre|Viscous soluble psyllium fibre
15939320|NCT03346720|Other|Semi-structured interviews|These interviews will be conducted following an interview guide. Interviews will be conducted in English or Thai at a place convenient and familiar to the interviewee. It is estimated that each interview will last between 45 minutes to an hour.
15939321|NCT03346720|Other|Focus group discussions (FGDs)|These will be conducted following an interview guide. FGDs will be conducted in English or Thai. In addition, a note taker will be present to take notes. FGDs will take place at a place convenient and familiar to the participants. It is estimated that each FGD will last between 1 to 1.5 hours. FGDs will typically consist of homogenous groups e.g. study nurses.
15939322|NCT03346707|Device|10.5 Tesla|10.5Tesla MR scan
15939323|NCT03346694|Device|Standard Island Dressing|participant randomized to control group before end of surgery to be applied on cardiovascular heart surgical sternal incision.
15939324|NCT03346694|Device|Prevena Negative Pressure wound dressing|participant randomized to dressing before end of surgery to be applied on cardiovascular heart surgical sternal incision.
15939325|NCT03346694|Device|Mepilex Border Post-Op Ag|Participant randomized to dressing before end of surgery to be applied on cardiovascular heart surgical sternal incision
15939326|NCT03346681|Drug|N-acetyl cysteine|The procedure involved would be the administration of N-acetylcysteine via nebulization, which would be administered to the patient by respiratory therapy in the dosage of 2 mL 20% solution acetylcysteine (or 4 mL of 10% solution) along with inhaled albuterol via endotracheal tube every six hours for 72 hours total. The control arm will have saline administered with the albuterol every six hours. Both arms will have additional bronchodilators administered as indicated clinically (bronchospasm, COPD, peak airway pressure elevation, etc.).
15939327|NCT03346668|Drug|Topical gabapentin|topical gabapentin 6% solution
15939328|NCT03346642|Drug|Decitabine|Decitabine is an investigational (experimental) drug that works by depleting DNA methyltransferase 1 (DNMT1), which can increase tumor antigens and histocompatibility leukocyte antigen (HLA) expression, enhances antigen processing, promotes T cell infiltration, and boosts effector T cell function.
15939329|NCT03346642|Drug|GVD chemotherapy|GVD regimen is a chemotherapy regimen consisted by Gemcitabine, Vinorelbine and Doxorubicine. Patients will be administrated with Gemcitabine 0.8 g/m2, Vinorelbine 30mg and Doxorubicin 20mg/m2 intravenously infusion.
15939330|NCT03346642|Drug|SHR-1210|SHR-1210 is a humanized anti-PD-1 monoclonal antibody.
15939331|NCT03346629|Drug|Mifepristone + Misoprostol|A single dose of 200 mg mifepristone (one tablet) to be taken orally either at home or at the hospital, followed 24-48 hours later with 400mcg misoprostol (buccal) at home. The participant will return to the hospital one to two hours after taking the initial dose of misoprostol to receive repeated doses of 400 mcg misoprostol until the abortion occurs.
15939332|NCT03346616|Other|Texting Group|See above in arm/group description
15939333|NCT03346616|Other|Non Texting Group|See above in arm/group description
15939334|NCT03346603|Other|urine culture and susceptibility testing|All patients will have a urine culture and susceptibility test ordered per standard care. Results of tests will identify which patients have antimicrobial-resistant organisms.
15939335|NCT03346590|Behavioral|Energy metabolism of patients suffering from RA|Energy metabolism of patients suffering from RA
15939336|NCT03346577|Device|stent or balloon|Endovascular treatment with stent or balloon according to current practice
15939337|NCT03346564|Behavioral|Ritual training program|Ritual training program including education and demonstration
15939338|NCT03346564|Behavioral|Routine care|
15939339|NCT03346551|Behavioral|"Evaluation of the quality attachment : Adult Attachment Narratives and CaMir scale"|"Evaluation of the quality attachment : Adult Attachment Narratives and CaMir scale"
15939340|NCT03346551|Behavioral|"Evaluation of the self-defining memories : Specific Questionnaire during an interview"|"Evaluation of the self-defining memories : Specific Questionnaire during an interview"
15939341|NCT03346538|Drug|Continuous infusion high-dose MCI-186|intravenous injection
15939342|NCT03346538|Drug|Continuous infusion low-dose MCI-186|intravenous injection
15939343|NCT03346538|Drug|Continuous infusion placebo|intravenous injection
15939344|NCT03346538|Drug|Approved dosing regimen MCI-186|intravenous injection
15939345|NCT03346538|Drug|Approved dosing regimen placebo|intravenous injection
15939346|NCT03346525|Drug|intramuscular benzathine penicillin G (BPG) prophylaxis|Intramuscular BPG prophylaxis (600,000 IU for children <30kg, 1.2 million IU for children ≥30kg), every 28 days.
15939347|NCT03346512|Procedure|Cardiac surgery|Cardiac surgery
15939348|NCT03346499|Biological|NK cells and IL-2|Natural Killer Cells
15939349|NCT03346486|Other|Control diet|Regular diet
15939350|NCT03346486|Other|Intervention diet|Brainfood dietary regime planned to be optimal for metabolism and cognitive function; having focus on regular meal frequency (breakfast, lunch and afternoon snack) and well-balanced light lunch at work according to the so-called plate model and optimized recipes- will be provided.
15939351|NCT03346460|Other|Tongue Scraping|Tongue scraping will be performed by the same operator in all patients. Posterior-anterior movements will be performed with the scraper over the lingual dorsum, followed by cleaning the scraper with a gauze. This procedure will be performed ten times in each patient, in order to standardize the mechanical removal of the tongue coating.
15939385|NCT03346174|Other|AAD|In this controlled trial with intra-subject design infants will be studied using multichannel intraluminal impedance pH (pH-MII) monitoring , during which they receive one 20 min session of AAD . The number of reflux episodes (RE) is the outcome measure. The results obtained during and 20 min after the intervention will be compared to a period of 20 min before treatment ( control ).
15939652|NCT03344250|Drug|Weekly EGFR BATs following SOC RT/TMZ|Standard of care: 6 weeks of RT and TMZ Experimental: 8 weekly doses of EGFR BATs following SOC RT and TMZ
15939352|NCT03346460|Radiation|aPDT|One session of aPDT will be performed with the photosensitizer (PS) urucum manipulated at a concentration of 20% (Fórmula e Ação®) in spray, to be applied in sufficient quantity to cover the middle third and back of the tongue (5 sprinkles) for 5 minutes for incubation. The excess will be removed with a sucker in order to keep the surface wet with the PS itself, without using water. Six points with a distance of 1 cm between them will be irradiated, considering the halo of light scattering and effectiveness of aPDT. The apparatus shall be precalibrated at wavelength 440-480nm for 60 seconds per point, irradiance of 450mW/cm and the light shall be irradiated so that a halo of 2cm diameter is formed per point.
15939353|NCT03346460|Radiation|Tongue scraper and aPDT|Tongue scraping will be performed by the same operator in all patients. Posterior-anterior movements will be performed with the scraper over the lingual dorsum, followed by cleaning the scraper with a gauze. This procedure will be performed ten times in each patient, in order to standardize the mechanical removal of the tongue coating. After, one session of aPDT will be performed with the photosensitizer (PS) urucum manipulated at a concentration of 20% (Fórmula e Ação®) in spray, to be applied in sufficient quantity to cover the middle third and back of the tongue (5 sprinkles) for 5 minutes for incubation. Six points with a distance of 1 cm between them will be irradiated, considering the halo of light scattering and effectiveness of aPDT. The apparatus shall be precalibrated at wavelength 440-480nm for 60 seconds per point, irradiance of 450mW/cm and the light shall be irradiated so that a halo of 2cm diameter is formed per point.
15939354|NCT03346447|Other|Artificial Fecal Enzyme|Artificial Fecal enzyme Trypsin/Chymotrypsin mixture
15939355|NCT03346434|Drug|Dupilumab|Solution for injection, subcutaneous (SC)
15939356|NCT03346434|Drug|Matching placebo|Solution for injection, subcutaneous (SC)
15939357|NCT03346421|Behavioral|diet and physical activity|
15939358|NCT03346408|Behavioral|Questionnaire|patient (self-questionnaire) and algologist physician (questionnaire)
15939359|NCT03346395|Behavioral|Problem solving based intervention|Problem solving based intervention
15939360|NCT03346395|Behavioral|Care as usual|Medical treatment, or behavioral therapy or a coordination of behavioral therapy and medical treatment. Meeting with a rehabilitation coordinator.
15939361|NCT03346369|Drug|Lanthanum Carbonate|Treatment with Lanthanum Carbonate 3 x 250 mg/day with meals during a first 14-day treatment period. Subsequently, treatment with Lanthanum Carbonate 3 x 500 mg/day with meals during a second 14-day treatment period
15939362|NCT03346356|Behavioral|Teenagers as cross-age SHCP teachers for younger youth|Implementation of the SHCP using teenagers as cross-age teachers for younger youth
15939363|NCT03346343|Device|Non-invasive forced airway oscillometry|This is a non-invasive device will measure lung function in spontaneously breathing infants. Infants will have a cushioned mask placed on his/her face and the device will take measurements as the infant breathes normally.
15939364|NCT03346330|Drug|TRK-750|TRK-750 capsule
15939365|NCT03346330|Drug|Placebo|Placebo capsule
15939366|NCT03346317|Device|disposable balloon uterine stent|The disposable balloon uterine stent is heart-shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to Foley catheter.
15939367|NCT03346317|Procedure|dried biological amnion graft|Uterine application of amnion membrane following hysteroscopic adhesiolysis. Other Name: Human amnion membrane
15939368|NCT03346317|Drug|estradiol valerate tablets+dydrogesterone tablets|oral estradiol valerate tablets+dydrogesterone tablets
15939369|NCT03346304|Other|Photodynamic Therapy (PDT)|Photodynamic Therapy (PDT) using photosensitiser drug Fotolon
15939370|NCT03346291|Behavioral|counseling|individual, weekly, smoking cessation counseling + over-the-counter nicotine patch
15939371|NCT03346278|Behavioral|Text Messaging Intervention|After completing baseline procedures, study staff will activate the intervention in the participant's profile on the text messaging platform if the participant was randomized to the intervention. The text messaging platform will deliver messages by an automated algorithm. Participants will receive 4 messages per week for 6 months.
15939372|NCT03346265|Other|Treatment A combined exercise program and gait training with sensory cues|Treatment A consisted in a combined exercise program of 40 min duration RMP
15939373|NCT03346265|Other|Treatment B Conventional physiotherapy|Conventional physiotherapy was composed of 4 sections of exercises, chiefly oriented to different body structures appropriate to movement (International Classification of Functioning, Disability and Health code)
15939374|NCT03346252|Drug|Botulinum Toxin type A|"All the participants meeting the inclusion criteria will be seen for a total of 4 visits and 3 phone interviews. Participants will complete a set of self-reporting questionnaires, assessing the disability associated with Headaches Attributed to TMD, and other pain-related TMD diagnoses, the impact of headaches on the quality of life, and psychosocial distress questionnaires.
~In addition, they will undergo 3 cycles of treatment, each 12 weeks apart."
15939375|NCT03346239|Behavioral|Gaze Contingent Music Reward Therapy|Feedback according to participants' viewing patterns, in order to modify their attention.
15939376|NCT03346239|Drug|Escitalopram|10-20 mg of Escitalopram
15939377|NCT03346239|Behavioral|Waitlist|Participants will wait for 12 weeks while in touch with the clinic, then receive GC-MRT for 8 weeks.
15939378|NCT03346226|Drug|Dexmedetomidine Hydrochloride|Dexmedetomidine is given to patients during spinal anesthesia at the dose of 0.5 μg/kg，adjusted the dose to keep BIS between 70-80 until 30 minutes before the end of surgery
15939379|NCT03346226|Drug|Propofol|Propofol is given with an initial ratio of 2-10mg/kg/h, when the operation starts，adjust the propofol's dose to keep BIS between 70-80 before the end of surgery
15939380|NCT03346213|Drug|MonoFer|Anaemic patients undergoing major surgery who would routinely be receiving intravenous iron 'MonoFer' will get this as part of routine care. They will then have a CPET repeated at least 10 days afterwards.
15939381|NCT03346200|Drug|Tamoxifen Oral Tablet|Randomised dose of tamoxifen 1 pill/day for 180 days
15939382|NCT03346200|Drug|Placebo Oral Tablet|Randomised dose of tamoxifen 1 pill/day for 180 days
15939383|NCT03346187|Drug|Active Comparator(Atorvastatin Calcium Trihydrate+Fenofibrate)|Lipitor(Atorvastatin Calcium Trihydrate 20mg/tablet) + Lipidil supra(Fenofibrate 160mg/tablet)
15939384|NCT03346187|Drug|Test drug(CKD-337)|CKD-337(Atorvastatin calcium trihydrate 20mg+choline fenofibrate 178.8mg/capsule)
15939548|NCT03345043|Biological|VAL-339851|Escalating dose levels
15939549|NCT03345043|Other|Placebo|Saline
15939386|NCT03346174|Other|BAAD|In this controlled trial with intra-subject design infants will be studied using multichannel intraluminal impedance pH (pH-MII) monitoring , during which they receive one 20 min session of BAAD . The number of reflux episodes (RE) is the outcome measure. The results obtained during and 20 min after the intervention will be compared to a period of 20 min before treatment ( control ).
15939387|NCT03346161|Other|"Usual care American Society of Plastic Surgeons booklet Breast Reconstruction"|-Booklet from the American Society of Plastic Surgeons about how to choose a breast reconstruction surgeon, what to expect during surgery, what is breast reconstruction, risks of breast reconstruction, recovery, costs, and questions to ask surgeon about breast reconstruction
15939388|NCT03346161|Other|Decision tool|-Interactive web based tool. Provides detail about breast reconstruction, asks participant questions about health and medications to personalize risks for breast reconstruction outcome. The tool also goes into pros/cons of breast reconstruction, talks about differences between types of reconstruction, helps people weigh when to have reconstruction (immediate vs. delayed), shows participants representative photos of breast reconstruction outcomes, and assesses patients' knowledge and preferences
15939389|NCT03346161|Other|Usual Care Group - Outcome Measures|"Section 1 Knowledge (primary outcome) - set of multiple choice questions about breast reconstruction, implants, flap surgeries, and side effects
~Section 2 Decisional Conflict Scale - 4 questions with yes/no answers dealing with participant's certainty about surgery (it total score less than 4, indicates higher decisional conflict)
~Section 3 Patient Activation Measures: 3 yes/no questions about participant's knowledge and trust of healthcare provider, sources of info about breast reconstruction, and different options available
~Section 4 Breast Reconstruction Decision Quality Instrument: 18 multiple choice questions about thought and processes that went into deciding about breast reconstruction
~Section 5 BREAST-Q: 3 questions about the breast reconstruction consultation appoint answers range from 0=no effort to 9=every effort."
15939390|NCT03346161|Other|Decision Group - Outcome Measures|"Section 1 Knowledge and Values Clarification Questions - set of multiple choice questions about the participants feelings on breast reconstruction, implants, flap surgeries, and side effects
~Section 2 Decisional Conflict SURE measure - 4 questions with yes/no answers dealing with participant's conflicts on surgery (if total score less than 4, indicates higher clinical significant decisional conflict)
~Section 3 Patient Activation Measures: 3 yes/no questions about participant's knowledge and trust of healthcare provider, sources of info about breast reconstruction, and different options available
~Section 4 Breast Reconstruction Decision Quality Instrument: 18 multiple choice questions about thought and processes that went into deciding about breast reconstruction (for those who have a clinical visit)
~Section 5 BREAST-Q: 3 questions about the breast reconstruction consultation appointment answers range from 0=no effort to 9=every effort (for those who have a clinical visit)."
15939391|NCT03346161|Other|Demographic and Background Questions|"Asks 15 questions
~Age, education, ethnicity, race, combined household income, zip code, disease stage, (3) questions about health insurance, (4) questions about participant's ability to work with numbers, heath literacy, health insurance status, and (1) question on if participant spoke to another provider about breast reconstruction decision"
15939392|NCT03346135|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo standard of care ASCT with a conditioning regimen of melphalan
15939393|NCT03346135|Biological|Daratumumab|Given IV
15939394|NCT03346135|Other|Laboratory Biomarker Analysis|Correlative studies
15939395|NCT03346135|Drug|Melphalan|Undergo standard of care ASCT with a conditioning regimen of melphalan
15939396|NCT03346122|Drug|JNJ-64991524 Dose Level 1|Participants will receive JNJ-64991524 at a Dose Level 1 in SAD Part 1 of study.
15939397|NCT03346122|Drug|JNJ-64991524 Dose Level 2|Participants will receive JNJ-64991524 at a Dose Level 2 in SAD Part 1 of study.
15939398|NCT03346122|Drug|JNJ-64991524 Dose Level 3|Participants will receive JNJ-64991524 at a Dose Level 3 in SAD Part 1 of study.
15939399|NCT03346122|Drug|JNJ-64991524 Dose Level 4|Participants will receive JNJ-64991524 at a Dose Level 4 in SAD Part 1 of study.
15939400|NCT03346122|Drug|JNJ-64991524 Dose Level 5|Participants will receive JNJ-64991524 at a dose of Dose Level 5 in SAD Part 1 of study.
15939401|NCT03346122|Drug|JNJ-64991524 Dose Level 6|Participants will receive JNJ-64991524 at a Dose Level 6 in SAD Part 1 and MAD part 2 of study.
15939402|NCT03346122|Drug|Placebo|Participants will receive matching placebo in all cohorts on Day 1 in Part 1 and Part 2 of the study.
15939403|NCT03346122|Drug|JNJ-64991524 Dose Level 7|Participants will receive JNJ-64991524 at a dose of Dose Level 7 in MAD Part 2 of study for 14 days.
15939404|NCT03346122|Drug|JNJ-64991524 Dose Level 8|Participants will receive JNJ-64991524 at a Dose Level 8 in MAD Part 2 of study for 14 days.
15939405|NCT03346122|Drug|JNJ-64991524 Dose Level 9|Participants will receive JNJ-64991524 at a Dose Level 9 in MAD Part 2 of study for 14 days.
15939406|NCT03346109|Radiation|medial group retropharyngeal node（MRLN） sparing|Patients in MRLN sparing group will not routinely receive MRLN irradiation; while patients in MRLN prophylactic irradiation group will always receive MRLN irradiation to 56Gy/33Fr.
15939407|NCT03346096|Drug|Thiotepa|fixed dose 5mg/kg on days -7-6
15939408|NCT03346083|Drug|Betrixaban|Factor Xa
15939409|NCT03346070|Drug|Sugammadex 2 mg/kg ABW|"Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Sugammadex (2 mg/kg by ABW) for reversal of moderate NMB.
~Moderate NMB is defined as the reappearance of a second twitch (T2) in response to TOF stimulations."
15939410|NCT03346070|Drug|Sugammadex 2 mg/kg IBW|"Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Sugammadex (2 mg/kg by IBW) for reversal of moderate NMB.
~Moderate NMB is defined as the reappearance of T2 in response to TOF stimulations."
15939411|NCT03346070|Drug|Sugammadex 4 mg/kg ABW|"Following administration of NMBA (Rocuronium or Vecuronium) to achieve deep NMB, participants received a single i.v. bolus of Sugammadex (4 mg/kg by ABW) for reversal of deep NMB.
~Deep NMB is defined as no response to TOF stimulations (TOF=0) and a detection target of 1-2 post-tetanic counts (PTCs)."
15939412|NCT03346070|Drug|Sugammadex 4 mg/kg IBW|"Following administration of NMBA (Rocuronium or Vecuronium) to achieve deep NMB, participants will receive a single i.v. bolus of Sugammadex (4 mg/kg by IBW) for reversal of deep NMB.
~Deep NMB is defined as no response to TOF stimulations (TOF=0) and a detection target of 1-2 post-tetanic counts (PTCs)."
15939550|NCT03345004|Biological|GAD-alum|Alhydrogel®-formulated recombinant human glutamic acid decarboxylase (rhGAD)
15939413|NCT03346070|Drug|Neostigmine + Glycopyrrolate|"Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Neostigmine (50 µg/kg; 5 mg maximum) and Glycopyrrolate (10 µg/kg; 1 mg maximum), dosed according to participant ABW for reversal of moderate NMB.
~Moderate NMB is defined as the reappearance of T2 in response to TOF stimulations."
15939414|NCT03346070|Drug|Rocuronium or Vecuronium|To achieve NMB, participants received steroidal NMBA Rocuronium Bromide or Vecuronium Bromide administered via i.v. infusion and dosed according to participant ABW. NMBAs were concomitant medications used per label as adjunct to general anesthesia.
15939415|NCT03346057|Drug|Sugammadex 2 mg/kg|Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Sugammadex 2 mg/kg for reversal of moderate NMB. Moderate block is a level of NMB in which peripheral nerve stimulation elicits one to four muscle twitches.
15939416|NCT03346057|Drug|Sugammadex 4 mg/kg|Following administration of NMBA (Rocuronium or Vecuronium) to achieve deep NMB, participants received a single i.v. bolus of Sugammadex 4 mg/kg for reversal of deep NMB. Deep block is a level of NMB in which peripheral nerve stimulation elicits no muscle twitches and high-frequency muscle stimulation elicits minimal levels of muscle contraction.
15939417|NCT03346057|Drug|Sugammadex 16 mg/kg|Following administration of NMBA (Rocuronium) to achieve deep NMB, participants received a single i.v. bolus of Sugammadex 16 mg/kg for reversal of deep NMB. Deep block is a level of NMB in which peripheral nerve stimulation elicits no muscle twitches and high-frequency muscle stimulation elicits minimal levels of muscle contraction.
15939418|NCT03346057|Drug|Neostigmine + Glycopyrrolate|Following administration of NMBA (Rocuronium or Vecuronium) to achieve moderate NMB, participants received a single i.v. bolus of Neostigmine (50 μg/kg; 5 mg maximum) and Glycopyrrolate (10 μg/kg; 1 mg maximum) for reversal of moderate NMB. Moderate block is a level of NMB in which peripheral nerve stimulation elicits one to four muscle twitches.
15939419|NCT03346057|Drug|Rocuronium|To achieve NMB, participants received steroidal NMBA Rocuronium Bromide administered via IV infusion and dosed according to participant body weight. NMBAs were concomitant medications used per label and at Investigator's discretion as an adjunct to general anesthesia.
15939420|NCT03346057|Drug|Vecuronium|To achieve NMB, participants received steroidal NMBA Vecuronium Bromide administered via IV infusion and dosed according to participant body weight. NMBAs were concomitant medications used per label and at Investigator's discretion as an adjunct to general anesthesia.
15939421|NCT03346044|Device|Carpentier-Edwards SAV bioprostheses|Performance of these bioprostheses
15939422|NCT03346044|Device|Medtronic Mosaic bioprostheses|
15939423|NCT03346031|Procedure|music therapy|patients will listen to music with an MP3 headset
15939424|NCT03346018|Diagnostic Test|Analysis of aqueous humor and plasma samples|"The collected samples will be analyzed as follow:
~Determination of the concentration of various cytokines, chemokines and groeth factors in aqueous humor and in the plasma.
~Analysis of the mononuclear cells ( T helper lymphocytes CD3+ and CD4+, T cytotoxic lymphocytes CD3+ CD8+, B lymphocytes CD19+, Natural killer lymphocytes CD56+ and CD3- and monocytes CD14+) present in the aqueous humor by cytofluorimetry.
~Evaluation of the presence of anti-human HSP70 antibodies in plasma samples by Western blot immunoprecipitation assays.
~Whenever possible (adequate number of cells), in vitro stimulation of mononuclear cells presence in aqueous humor with epitopes from tuberculosis mycobacterium antigens and the analysis of cytokines production in the supernatants."
15939425|NCT03346005|Device|Aeonose|An electronic nose device is an artificial olfactory system that analyses volate organic compounds (VOCs) in exhaled breath. The AeonoseTM is a handheld device of 650 gram. A nose clip will be used to prevent the entry of non-filtered air and patients will be instructed to enclose the mouthpiece with their mouth at all times. A measurement cycle lasts for about 15 minutes, of which 5 minutes of in-and exhalation by the patient takes place.
15939426|NCT03345992|Drug|Clarithromycin|Clarithromycin two vials of lyophilised powder for reconstitution as solution for IV administration per patient, once daily, for four consecutive days.
15939427|NCT03345992|Drug|Water for injection|Water for injection 20 ml will be administered, diluted in D/W 5%, IV, once daily for four consecutive days
15939428|NCT03345979|Combination Product|Aripiprazole Lauroxil|Intramuscular injection; study drug provided using a pre-filled syringe
15939429|NCT03345979|Drug|Paliperidone Palmitate|Intramuscular injection
15939430|NCT03345966|Diagnostic Test|Bmi-1 antibody|B-lymphoma Moloney murine leukemia virus insertion region-1
15939431|NCT03345953|Drug|BP 1.4979|Double blind versus placebo
15939432|NCT03345953|Drug|Placebo|Double blind versus placebo
15939433|NCT03345940|Drug|Fingolimod|Fingolimod is a currently approved oral DMT for the treatment of relapsing remitting MS. It modulates sphingosine-1 phosphate receptors.
15939434|NCT03345940|Drug|Dimethyl Fumarate|Dimethyl Fumarate is a currently approved oral DMT for the treatment of relapsing remitting MS. The mode of action comprises immunomodulatory effects and an activation of nuclear (erythroid-derived 2) related factor mediated antioxidative response pathways leading to additional cytoprotective effects.
15939435|NCT03345927|Other|no intervention|no intervention
15939436|NCT03345914|Drug|Dupilumab|"Pharmaceutical form: Solution for injection in pre-filled syringe;
~Route of administration: Subcutaneous (SC)"
15939437|NCT03345914|Drug|Matching Placebo|"Pharmaceutical form: Solution for injection;
~Route of administration: Subcutaneous (SC)"
15939438|NCT03345914|Other|Background Treatment: Topical Corticosteroids|All participants are required to initiate treatment with a medium potency TCS using a standardized regimen. It is recommended that participants use triamcinolone acetonide 0.1% cream, fluocinolone acetonide 0.025% cream, or clobetasone butyrate 0.05%.
15939439|NCT03345914|Other|Background Treatment: Moisturizers|All participants should apply moisturizers throughout the study. All types of moisturizers are permitted, but participants may not initiate treatment with prescription moisturizers. Participants may continue using stable doses of such moisturizers if initiated before the screening visit.
15939440|NCT03345901|Drug|Pemafibrate|0.2 mg orally BID - twice daily
15939441|NCT03345901|Drug|Placebo|orally BID - twice daily
15939442|NCT03345888|Other|predictive power of end-tidal carbon dioxide|end-tidal carbon dioxide predicts resuscitation outcomes
15939551|NCT03345004|Dietary Supplement|Vitamin D|Oil suspension of Vitamin D
15939552|NCT03345004|Biological|Placebo for Diamyd (GAD-alum)|Alhydrogel® only
15939443|NCT03345875|Diagnostic Test|HPV self collection, followed by visual assessment of the cervix for treatment (VAT) and treatment|Women who test HPV positive are offered visual assessment for treatment, with treatment method (cryotherapy, LEEP, or biopsy) based on visual assessment findings.
15939444|NCT03345862|Behavioral|non-pharmacological multicomponent|Following the proposal of Nicholson & Shellman, (2013) collected in its CARELINK program, an intervention is proposed that includes: 6 sessions at home [30-60 minutes] for 16 weeks (1 fortnightly session) and 5 telephone sessions [20 min.] That will be intercalated (in the 16 weeks) depending on the particular characteristics of each person. The first visit, aimed at defining objectives and creating a relationship of trust for future visits.
15939445|NCT03345849|Drug|Upadacitinib|Oral; Tablet
15939446|NCT03345849|Drug|Placebo for Upadacitinib|Oral; Tablet
15939447|NCT03345836|Other|Matching placebo for upadacitinib|Oral; Tablet
15939448|NCT03345836|Drug|upadacitinib|Oral; Tablet
15939449|NCT03345823|Drug|Upadacitinib|Oral; Tablet
15939450|NCT03345823|Drug|Placebo for Upadacitinib|Oral; Tablet
15939451|NCT03345810|Drug|Durvalumab|Induction: (1125 mg) cycle Q3W Maintenance: (1500 mg) cycle Q4W
15939452|NCT03345810|Drug|Vinorelbine|(30 mg/m2 D1 + D8 as infusion) cycle Q3W
15939453|NCT03345810|Drug|Gemcitabine|(1000 mg/m2 D1 + D8 as infusion) cycle Q3W
15939454|NCT03345810|Drug|nab-Paclitaxel|(100 mg/m2 intravenous infusion over 30 minutes on D1, D8) cycle Q3W
15939455|NCT03345810|Drug|Carboplatin|(AUC = 5 mg•min/mL on Day 1) cycle Q3W
15939456|NCT03345797|Drug|Testosterone Nasal Gel [Natesto]|nasal gel containing 4.5% w/w testosterone
15939460|NCT03345771|Combination Product|Antimicrobial Barrier Dressing|Ionic Silver is a soft, nonwoven pad or ribbon that features the gelling benefits of Hydrofiber technology plus antimicrobial ionic silver.
15939461|NCT03345771|Device|Negative Pressure Wound Therapy (NPWT)|PICO provides suction known as negative Pressure wound Therapy (NPWT) which draws out excess fluid from a wound and protects the injured area from getting dirty to ultimately help promote healing. PICO consists of an nPwT pump connected to an absorbent gentle adhesive dressing
15939462|NCT03345758|Other|outcome|telephone to patients to finish SF-36 (the MOS item short from health survey,SF-36)，EQ-5D(EuroQol-5 Dimensions,EQ-5D)， AMT-4（Abbreviated Mental Test-4,AMT-4）and MMSE（Mini-mental State Examination,MMSE） to make assessments of their physical and mental health, cognitive function and social adaptation after discharge
15939463|NCT03345745|Diagnostic Test|salivary samples|Salivary Hs-CRP, Fetuin-A and S100A12 levels and salivary flow rates were evaluated at baseline and a month after the treatments
15939464|NCT03345732|Diagnostic Test|ICG and SPY system for wound complications|
15939465|NCT03345719|Diagnostic Test|3D Cone-Beam Imaging|
15939466|NCT03345706|Procedure|Selective cerebral hypothermia|Subjects will be transferred to ICU for the 12-hour selective cerebral hypothermia procedure. Cooling will be initiated and targeted to reach ipsilateral nasal temperature of 27±2°C for 12 hours, followed by controlled rewarming.
15939467|NCT03345706|Procedure|Regular hypothermia|Subjects will be transferred to ICU for the 12-hour selective cerebral hypothermia procedure. Subjects will receive systemic hypothermia via ECMO at 33.5±0.5°C (33-34°C) for 48 hours at the same time.
15939468|NCT03345693|Device|MoTrack Therapy|A software that runs on a tablet or computer that reads information from a Universal Serial Bus external sensor and instructs patients in their exercises, giving patients feedback as necessary, and recording patient progress and activity.
15939469|NCT03345680|Other|Referred to a specific hospital for treatment|To King Saud University Dental College, treatment will be provided free of charge to the referred participants.
15939470|NCT03345667|Drug|lucentis|Use of lucentis and other anti-vegf in patients with diabetic retinopathy
15939471|NCT03345654|Other|Toolset-directed hearing aid fit|In the toolset-directed arm, audiogram, age and working memory capacity will be measured and the clinician will then use a touchpad application (an implementation of our individualized prediction programs) to guide hearing aid parameter choices.
15939472|NCT03345654|Other|Standard-of-care hearing aid fit|In the standard-of-care fit, working memory capacity will not be measured and no touchpad application will be used. The clinician will select the hearing aid signal processing parameters based on his/her own knowledge and clinical experience
15939473|NCT03345641|Other|describe precocious maternal impressions when confronting the premature birth of her infant|
15939474|NCT03345628|Drug|Sedatives|sedated group received sedative drugs to tolerated intubation and ventilation
15939475|NCT03345615|Diagnostic Test|30-day ambulatory cardiac event monitor|SpiderFlash® 30-day ambulatory cardiac event monitoring will be worn upon discharge.
15939476|NCT03345602|Diagnostic Test|serum S100B protein assay measurement|serum S100B protein assay measurement within the 3 hours after head trauma
15939477|NCT03345589|Drug|18-22mg/kg/d Ursodeoxycholic|18-22mg/kg/d Ursodeoxycholic
15939478|NCT03345589|Drug|13-15mg/kg/d Ursodeoxycholic|13-15mg/kg/d Ursodeoxycholic
15939479|NCT03345576|Device|Testosterone and LPWS|Twelve patients will undergo 1 year of supervised training examining the effects of testosterone replacement therapy (TRT) and long pulse width stimulation (LPWS) in persons with denervated spinal cord injury.
15939480|NCT03345576|Drug|Testosterone and standard NMES|Twelve patients will undergo 1 year of supervised training examining the effects of testosterone replacement therapy (TRT) and standard surface neuromuscular electrical stimulation (NMES) in persons with denervated spinal cord injury.
15939481|NCT03345563|Behavioral|Body Mind Training (BMT)|"Participants will practice BMT under the instruction of a BMT instructor. There will be 24 sessions. Each session will last 60 minutes and will occur twice a week for 12 weeks. Each session will include both light physical exercise and mind training.
~Sessions will be supplemented with home-based practice using an instructional DVD and handouts. Participants will be instructed to practice at least 30 minutes a day (at least 3 days per week) throughout the intervention and post-intervention period."
15939553|NCT03345004|Dietary Supplement|Placebo for Vitamin D|Placebo oil suspension for Vitamin D
15939653|NCT03344224|Diagnostic Test|laboratory test|laboratory test
15939654|NCT03344211|Drug|Enzalutamide|Given PO
15939482|NCT03345563|Behavioral|Body Training (BT):|Participants will practice BT under the instruction of a BT instructor. There will be 24 sessions. Each session will last 60 minutes and will occur twice a week for 12 weeks. Sessions will be supplemented with home-based practice using an instructional DVD and handouts. Participants will be instructed to practice at least 30 minutes a day (at least 3 days per week) throughout the intervention and post-intervention period.
15939483|NCT03345563|Behavioral|Usual Care (UC)|Participants in the usual care arm will receive care as normal and will not attend classes but will complete the same assessments as participants in the BMT and BT classes.
15939484|NCT03345550|Drug|Omega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA & 100 mg EPA)) or placebo capsules.|Participants will be randomized to receive fish oil 1000 mg (contains 500 mg DHA & 100 mg EPA) or placebo capsules.
15939485|NCT03345550|Drug|Placebo - Cap|Participants will be randomized to receive fish oil 1000 mg (contains 500 mg DHA & 100 mg EPA) or placebo capsules (olive oil capsules that look identical to the intervention DHA+EPA).
15939486|NCT03345537|Other|Non interventional study|Non interventional study - only data collected and one blood sample additional
15939487|NCT03345524|Other|Peer-Buddy System|"2-4 30-minute in person sessions with Peer Buddy (2 before and 2 after receiving CPAP)
~Standard of care CPAP educational training
~8-10 phone conversations with Peer Buddy over 3 month period
~Subsequent 3 months use of phone system to contact Peer Buddy as needed"
15939488|NCT03345524|Other|Usual Care|"Standard of care CPAP educational training
~Educational Brochures and DVD videos mailed to participants (12 times)"
15939489|NCT03345511|Procedure|Ultrasound Guided Caudal Block|Using an external ultrasound probe, the investigators guided a 18 gauge epidural needle into the caudal space and injected a local anesthetic solution consisting in bupivacaine 0.25%, lidocaine 1% and dexamethasone 8mg in the caudal space.
15939490|NCT03345498|Drug|Entecavir|Entecavir is the antiviral drug of choice recommended for hepatitis B virus treatment in presence of decompensated cirrhosis
15939491|NCT03345485|Drug|Tinostamustine (EDO-S101)|The study is designed as an open label, Phase 1/2 trial of single agent EDO-S101. The Phase 1 portion of the study is designed to define the MTD by evaluating toxicities during dose escalation until MAD. The Phase 2 portion of the study is designed to evaluate ORR and SD that persists for at least 4 months of the RP2D.
15939492|NCT03345472|Device|Spinal Cord Stimulation System|Implanted neurostimulation system (neurostimulator and leads) with high dose stimulation parameters.
15939493|NCT03345459|Other|ICare Prevent (internet-based treatment for depression in college students)|ICare Prevent (internet-based treatment for depression in college students): 7 weekly sessions and 1 booster session. Each session requires about 30-45 minutes to complete. All sessions are accessed online, and it is a guided treatment (i.e., each patient provided an eCoach).
15939494|NCT03345446|Diagnostic Test|Cardiac MRI|Cardiac MRI is a test that allows us to look at how the heart muscle works and the amount of scar tissue in your heart. Screening questions will be asked to make sure that patients are not pregnant, and that they have kidney function tests to confirm that IV contrast used (gadolinium) during the MRI is safe for them.
15939495|NCT03345433|Behavioral|interactive group drumming sessions|interactive group drumming sessions
15939496|NCT03345420|Radiation|Hypofractionated Radiation Therapy|Undergo hypofractionated radiation therapy
15939497|NCT03345407|Drug|Placebo ELLIPTA|Placebo will be administered via oral inhalation route once daily in the morning.
15939498|NCT03345407|Drug|Nemiralisib ELLIPTA 50 µg|Nemiralisib is a potent and highly selective inhaled PI3Kd inhibitor being developed as an anti-inflammatory for the treatment of inflammatory airways disease. Nemiralisib 50 µg will be administered as a dry powder inhaler via oral inhalation route. In addition, subjects will receive SOC therapy for the index acute moderate or severe exacerbation of COPD.
15939499|NCT03345407|Drug|Nemiralisib ELLIPTA 100 µg|Nemiralisib is a potent and highly selective inhaled PI3Kd inhibitor being developed as an anti-inflammatory for the treatment of inflammatory airways disease. Nemiralisib 100 µg will be administered as a dry powder inhaler via oral inhalation route. In addition, subjects will receive SOC therapy for the index acute moderate or severe exacerbation of COPD.
15939500|NCT03345407|Drug|Nemiralisib ELLIPTA 250 µg|Nemiralisib is a potent and highly selective inhaled PI3Kd inhibitor being developed as an anti-inflammatory for the treatment of inflammatory airways disease. Nemiralisib 250 µg will be administered as a dry powder inhaler via oral inhalation route. In addition, subjects will receive SOC therapy for the index acute moderate or severe exacerbation of COPD.
15939501|NCT03345407|Drug|Nemiralisib ELLIPTA 500 µg|Nemiralisib is a potent and highly selective inhaled PI3Kd inhibitor being developed as an anti-inflammatory for the treatment of inflammatory airways disease. Nemiralisib 500 µg will be administered as a dry powder inhaler via oral inhalation route. In addition, subjects will receive SOC therapy for the index acute moderate or severe exacerbation of COPD.
15939502|NCT03345407|Drug|Nemiralisib ELLIPTA 750 µg|Nemiralisib is a potent and highly selective inhaled PI3Kd inhibitor being developed as an anti-inflammatory for the treatment of inflammatory airways disease. Nemiralisib 750 µg will be administered as a dry powder inhaler via oral inhalation route. In addition, subjects will receive SOC therapy for the index acute moderate or severe exacerbation of COPD.
15939503|NCT03345407|Drug|Albuterol (Salbutamol) MDI or nebules|Albuterol (Salbutamol) MDI or nebules will be provided to all subjects as a rescue medication.
15939504|NCT03345407|Drug|Standard of care therapy|SoC therapy for the index exacerbation is defined as treatment with oral/systemic corticosteroid (prednisone 40 mg/day or equivalent) for 5 days and antibiotic for 7 days. Subjects will receive SoC as prescribed by the Investigator or medically qualified designee. The dose and/or duration of prednisone and/or the antibiotic can be modified according to the Investigator's/medically qualified designee's judgment or according to local country/institution practice.
15939505|NCT03345394|Behavioral|Contingency Management|Participants will receive vouchers with monetary value for submitting crack cocaine negative urine samples
15939506|NCT03345394|Behavioral|Standard treatment|Participants will receive the standard treatment offered at Unidade Recomeço Helvétia treatment program
15939507|NCT03345381|Other|SKY + ASTM + usual care|Sudarshan Kriya Yoga (SKY) followed by Automatic Self Transcending Meditation (ASTM) involves breathing exercise followed by meditation.
15939508|NCT03345381|Other|Usual care|Treatment as usual
15939580|NCT03344731|Device|Non-invasive brain stimulation|Transcranial Magnetic Stimulation (TMS)
15939655|NCT03344211|Other|Laboratory Biomarker Analysis|Correlative studies
15939509|NCT03345368|Device|rTMS|Patients will be stimulated in the dorso lateral frontal cortex. First, the motor threshold will be determined for each patient. To induce currents to the left primary sensory-motor cortex hand area (M1/S1) the coil will be placed over the scalp oriented at 45 ° from the mid-sagittal plane while subjects will sit comfortably on a chair. The coil will be systematically moved in this area until a contraction of the abductor will be identified. Motor evoked potentials (MEPs). MEPs will be registered with surface electrodes on the left hand abductor pollicis muscle using the same Magstim equipment. Then the parameters will be adjusted for the stimulation as was described before.
15939510|NCT03345368|Device|sham rTMS|As well as the rTMS group, the motor threshold of each patient will be determined. They will experience a similar rTMS session with the difference that they not will be stimulated.
15939511|NCT03345368|Other|Diet|This intervention will be applied to both groups, rTMS and sham group, as a combined therapy. The diet is low in carbohydrates, like sugary foods, pasta and bread. Instead, patients eat food with protein, natural fats and vegetables.
15939512|NCT03345355|Diagnostic Test|Imaging|Coronal oblique T1, Coronal oblique and axial STIR, Coronal oblique T1 Dixon, Coronal oblique and Axial T2 Dixon and T1 Dixon post Gadolinium
15939513|NCT03345342|Drug|PP6M|Participants will receive intramuscular injection of PP6M.
15939514|NCT03345342|Drug|PP3M 350 mg eq.|Participants will receive intramuscular injection of PP3M 350 mg eq.
15939515|NCT03345342|Drug|PP3M 525 mg eq.|Participants will receive intramuscular injection of PP3M 525 mg eq.
15939516|NCT03345342|Drug|PP1M|Participants will receive intramuscular injection of PP1M 50 to 150 mg eq.
15939517|NCT03345342|Other|Placebo|Participants will receive matching placebo.
15939518|NCT03345316|Drug|FFI-1010|Intravenous single dosing
15939519|NCT03345303|Drug|Bortezomib|Bortezomib Injectable Solution
15939520|NCT03345290|Device|PET with a cerebral step|Positron Emission Tomography with a cerebral step before to carry out the standard Position Emission Tomography
15939521|NCT03345290|Device|Central blood pressure measurement|Central blood pressure measurement
15939522|NCT03345290|Other|Neurocognitive tests|Mini Mental State Examination, MMSE, Mini International Neuropsychiatric Interview MINI and Frontal Assessment Batery FAB
15939523|NCT03345277|Other|Continuous Temperature monitoring|Residents in a long term care facility will wear a thermometer continuously for 3 months, measuring their body temperature
15939524|NCT03345264|Behavioral|Online, interactive self-help program|Participants will receive access to the program, which provides: In-depth information specific to cancer sites and treatments, guidance on medical options for cancer-related sex or fertility problems, personalized goal-setting with progress tracking and relapse prevention, self-help exercises on overcoming sexual, relationship, and dating problems, videos of survivors' stories, and video vignettes with actors.
15939525|NCT03345251|Device|Hydrotubation|
15939526|NCT03345238|Procedure|Deep Dry Needling|Deep Dry Needling in the upper trapezious muscle is an invasive technique of Physical Therapy.
15939527|NCT03345225|Device|SureFire Infusion System|Surefire is a modified microcatheter with an expandable cone at its tip to prevent retrograde reflux of flow and change flow dynamics downstream.
15939528|NCT03345225|Device|Standard Endhole Microcatheter|A Microcatheter with a single hole at the end for a infusion.
15939529|NCT03345212|Other|Exercise training|The rehabilitation program comprises interval ergometer training, dumbbell training, respiratory therapy, mental training and guided walks for 5-7 times/week.
15939530|NCT03345199|Other|Inspiratory Muscle Trainer (IMT)|During the 10-week training period, participants will perform exercises using a Threshold Inspiratory Muscle Trainer (IMT) at 3 sets of 15 repetitions per day. The initial resistance of the IMT unit will be at 30% of participants' maximum inspiratory pressure (MIP). Resistance for the IMT unit will be increased progressively and adjusted weekly by a licensed physical therapist based on participant's MIP at baseline, Borg perceived rate of exertion, and symptoms.
15939531|NCT03345186|Other|nurse led plus standard of care|structured nurse led patient management programme: Patient education will be done by a specialised nurse and nurse consultations and phone calls will be done.
15939532|NCT03345173|Drug|CI-581-a|Two infusions in the context of naltrexone induction protocol.
15939533|NCT03345173|Drug|CI-581-b|Two infusions in the context of naltrexone induction protocol.
15939535|NCT03345147|Other|High Vitamin A intake|Total Vitamin A stores will be assessed by isotopic measurement, 13C-Retinol will be given to the subject and blood wil be drawn on Day 4 to assess the isotopic dilution in the plasma. Other biochemical indicators will be assessed too, along with Dietary assessment (Food Frequency, 24 hours recalls).
15939536|NCT03345147|Other|Normal Vitamin A intake|Total Vitamin A stores will be assessed by isotopic measurement, 13C-Retinol will be given to the subject and blood wil be drawn on Day 4 to assess the isotopic dilution in the plasma. Other biochemical indicators will be assessed too, along with Dietary assessment (Food Frequency, 24 hours recalls).
15939537|NCT03345134|Drug|MK-3475 and BCG|combination treatment with MK-3475 and BCG after endoscopic ablation
15939538|NCT03345108|Device|Denture Adhesive Cream (Conventional Application)|The adhesive cream will be extruded from a pre-dosed syringe. 1.6 g of adhesive per treatment will be applied to each participant's dentures. This dose will be split as 1.00±0.05g for the maxillary and 0.60±0.05g for the mandibular dentures.
15939539|NCT03345108|Device|Denture Adhesive (Continuous Strip Application)|The adhesive cream will be extruded from a pre-dosed syringe. 1.6 g of adhesive per treatment will be applied to each participant's dentures. This dose will be split as 1.00±0.05 g for the maxillary and 0.60±0.05 g for the mandibular dentures.
15939540|NCT03345108|Other|No Adhesive|No adhesive applied.
15939541|NCT03345095|Drug|Marizomib|Intravenous administration of Marizomib
15939542|NCT03345095|Drug|Temozolomide|Oral Administration of Temozolomide
15939543|NCT03345095|Radiation|radiotherapy|60 Gy in 30 fractions over 6 weeks
15939544|NCT03345082|Biological|OPT-302|Intravitreal injection
15939545|NCT03345082|Biological|ranibizumab|Intravitreal injection
15939546|NCT03345082|Other|sham intravitreal injection|Sham (mock) intravitreal injection
15939547|NCT03345056|Procedure|vitrectomy with planned foveal detachment|23 gauge vitrectomy, posterior hyaloid detachment, internal limiting membrane peeling , sub-macular BSS injection using 38 gauge canula
15939558|NCT03344965|Drug|Olaparib|olaparib tablets bid daily continuously on a 21 day cycle until progression, intolerable toxicity, consent withdrawn, patient noncompliance or death.
15939559|NCT03344952|Drug|Botulinum toxin type A|Repeated injections to hypertonic muscles
15939560|NCT03344952|Other|Physical therapy|3 weeks intensive program 1 week -10 days after BoNT-A injections
15939561|NCT03344926|Behavioral|ACTsmart|"Participant receive ACT treatment via a smart phone application, including psychologist support via a message function within the application.
~Treatment content is divided into four modules:
~education about pain behaviors, exposure and acceptance and commitment therapy
~education about pain physiology
~exercises on changing behaviors, acceptance, mindfulness, defusion and exposure
~value based exposure in the participant's daily life"
15939562|NCT03344913|Behavioral|Walking|walking 30 minutes per day, three days/week for 6 weeks with a member of study team.
15939563|NCT03344887|Other|RBC Transfusion from male donor|Patients requiring an RBC transfusion for the treatment of anemia will receive products from a male donor at initial and any subsequent hospitalizations during the trial period.
15939564|NCT03344887|Other|RBC Transfusion from female donor|Patients requiring an RBC transfusion for the treatment of anemia will receive products from a female donor at initial and any subsequent hospitalizations during the trial period.
15939565|NCT03344874|Device|Stethee®|Stethee® is a new wireless digital stethoscope.
15939566|NCT03344874|Device|3MTM Littmann® Classic IIITM|3MTM Littmann® Classic IIITM is the conventional stethoscope.
15939567|NCT03344861|Drug|Porfimer Sodium|Porfimer sodium (Photofrin®) will be injected intravenously at a dose of 2 mg/kg.
15939568|NCT03344861|Device|Fiber optic|After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). An optical fiber diffuser length matching the tumor length will be placed in the lesion or adjacent to the lesion under fluoroscopy guidance. After the placement of the optical fiber, the laser light will be applied at a dose of 200 J/cm of diffuser length.
15939569|NCT03344848|Device|Orion Visual Cortical Prosthesis System|The Orion Visual Cortical Prosthesis System is intended to stimulate the medial surface of the occipital lobe in the visual cortex to induce visual perception in blind individuals.
15939570|NCT03344835|Other|No intervention|
15939571|NCT03344822|Diagnostic Test|68Ga-PSMA-11|radioactive tracer for PET-CT (68Ga-PSMA-11)
15939572|NCT03344822|Diagnostic Test|18F-Choline PET-CT|radioactive tracer for PET-CT (18F-Choline PET-CT)
15939573|NCT03344796|Behavioral|Goal attainment|After reviewing daily UV exposure in the prior 10 days, participants will be randomized to structured (select strategies from a list of 7 items) or unstructured (submit a free text description of a strategy) goal attainment.
15939574|NCT03344783|Other|PUFA and R-TFA|PUFA and R-TFA exposure were assessed mainly from maternal dietary, blood sample or breast milk. Exposure period was restricted to early life. Dietary PUFA and R-TFA were measured by food-frequency questionnaire (FFQ) or diet history questionnaire (DHQ). The profile of PUFA and R-TFA in the blood sample and breast milk were examined by using gas chromatography
15939575|NCT03344770|Device|Active rESWT|5,000 pulses of rESWT, with 0.16mJ/mm2 of energy at a frequency of 20Hz once a week for three weeks.
15939576|NCT03344770|Device|Sham rESWT|5,000 pulses of rESWT, with 0.0 mJ/mm2 of energy at a frequency of 20Hz once a week for three weeks.
15939577|NCT03344757|Behavioral|Cultural CBSM|The Culturally Adapted Cognitive Behavioral Stress Management (C-CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own. The delivery of C-CBSM places a greater emphasis on salient sociocultural determinants of symptom burden and Health Related Quality of Life (HRQoL) in Hispanics (e.g., fatalistic attitudes, family interdependence, perceived discrimination, machismo).
15939578|NCT03344757|Behavioral|Standard CBSM|The standard Cognitive Behavioral Stress Management (CBSM) Intervention is a 10 weekly in-person group program. Each session will last about 90 minutes. The meetings will give facts on stress, coping with difficult events, managing anger, social support and stress reactions. Participants will also receive information on how to practice relaxation on their own.
15939579|NCT03344731|Behavioral|Cognitive evaluation|Cognitive task
15939581|NCT03344705|Biological|IM19 CAR-T|All patients will be treated with fludarabine and cyclophosphamide for 3 days. Two days later, Cells Expressing an Anti-CD19 Chimeric Antigen Receptor will be infused.
15939582|NCT03344705|Drug|Fludarabine|Two days before cell infusion,all patients will be treated with fludarabine for 3 days
15939583|NCT03344705|Drug|Cyclophosphamide|Two days before cell infusion,all patients will be treated with cyclophosphamide for 3 days
15939584|NCT03344692|Drug|Alirocumab|prefilled pen containing 75 mg of Praluent (Alirocumab) in 1 ml of solution
15939585|NCT03344692|Other|Placebo|prefilled pen containing 1 ml of solution without Praluent
15939586|NCT03344679|Drug|Bupivacaine 0.25%|Bupivacaine 0.25% for PECS block
15939587|NCT03344679|Drug|Adenosine 12mg|Adenosine 12 mg for PECS block
15939588|NCT03344679|Drug|Magnesium Sulphate 500 mg|Magnesium sulphate 500 mg for PECS block
15939593|NCT03344653|Device|Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System|Medtronic Resolute Onyx Zotarolimus-Eluting Coronary Stent System Treatment Followed by 1 month DAPT
15939594|NCT03344653|Device|Biosensors BioFreedom BA9 Drug Coated Coronary Stent|Biosensors BioFreedom BA9 Drug Coated Coronary Stent Followed by 1 month DAPT
15939595|NCT03344640|Drug|secukinumab|AIN457 300 mg subcutaneously for 12 weeks
15939596|NCT03344640|Other|Placebo|Placebo to match AIN457 subcutaneously for 12 weeks
15939597|NCT03344627|Drug|Meropenem standard dose|"Empirical with 1 g meropenem intravenous infusion in 30 minutes then 1 g intravenous infusion in 3 hours every 8 hours.
~Dosage is adjusted in case of renal dysfunction. Duration of therapy is varied regarding source(s) of infection."
15939598|NCT03344627|Drug|Meropenem high dose|"Empirical with 2 g meropenem intravenous infusion in 30 minutes then 2 g intravenous infusion in 3 hours every 8 hours.
~Dosage is adjusted in case of renal dysfunction. Duration of therapy is varied regarding source(s) of infection"
15939599|NCT03344614|Drug|raltitrexed combined with apatinib|raltitrexed, 3 mg/㎡, ivgtt, d1, apatinib 500 mg, QD po, d1-21, Every 3 weeks for 1 cycles
15939600|NCT03344601|Behavioral|physical activity|The program will consist of 18 face-to-face coaching sessions (~1 hour) over 12 months. The timing of these sessions will be decided between participant and coach. A coaching manual will be used to provide a structured approach to coaching sessions, focussing on physical activity engagement (specifically aerobic and strengthening exercise) and adherence to exercise. The intervention will take place in the participant's home or in a rehabilitation facility at the research site. Each participant will be provided with a choice of exercise equipment options (e.g. exercise bike, weights, therabands), gym membership or use of online exercise resources. Participants will develop physical activity goals that will be monitored and adjusted throughout the program. Physical activity diaries will be completed to record the amount and type of physical activity involvement. Wearable activity monitors will also be used to facilitate/monitor physical activity and sedentary behaviours.
15939601|NCT03344588|Procedure|artery preserving varicocelectomy|During sub-inguinal varicocelectomy, testicular arteries will be spared with aid of by intraoperative Doppler US (VTI intraoperative Doppler system 20 MHz). The arteries will be carefully dissected by a micro-dissector, separated over a vessel loupe, and then the remaining veins will be ligated using vicryl 3/0.
15939602|NCT03344588|Procedure|artery ligation varicocelectomy|During sub-inguinal varicocelectomy, all vascular channels will be ligated without identifying or sparing the internal spermatic arteries.
15939603|NCT03344575|Procedure|Conventional defect closure|Laparoscopic suturing of the defect prior to placing an intraperitoneal Onlay Mesh
15939604|NCT03344575|Procedure|Peritoneal bridging|Laparoscopic closure of the defect by using a peritoneal flap prior to placing an intraperitoneal Onlay Mesh
15939605|NCT03344562|Device|CES|Patients will receive cranial electrical stimulation once a day for 20 minutes over 7 days. They will be allowed to increase the stimulation level on Day 2. A wrist worn actigraph will record sleep. Patients may elect to receive standard of care sleep medication if not satisfied with sleep.
15939606|NCT03344562|Device|CES|Patient will receive sham electrical stimulation once a day for 20 minutes over 7 days.
15939607|NCT03344549|Behavioral|Renal nutrition teleconsultation|Renal Nutritional teleconsultation for patients with diabetic kidney disease without dialysis, monthly for 4 months.
15939608|NCT03344549|Behavioral|Face-to-face consultation of renal nutrition|Face-to-face consultation of renal nutrition for patients with diabetic kidney disease without dialysis, monthly for 4 months.
15939609|NCT03344536|Drug|Fulvestrant|Fulvestrant will be administered according to its approved dose of 500 mg intramuscularly on days 1, 15, 29 and then every 28 days (+/-3 days) thereafter.
15939610|NCT03344536|Drug|Debio 1347|Debio 1347 will be administered orally daily (1 cycle is 28 days) and the dose of Debio 1347 could be deescalated.
15939611|NCT03344523|Drug|Iron protein succinylate oral solution|Iron protein succinylate oral solution
15939612|NCT03344523|Other|standard treatment|standard treatment
15939656|NCT03344211|Radiation|Radium Ra 223 Dichloride|Given IV
15939613|NCT03344510|Device|Kinetic Anesthesia Device|A vibrating device held to the skin in close proximity to the lidocaine injection, intended to diminish discomfort by the gate control theory of pain
15939614|NCT03344510|Other|Control|One injection will be administered without the kinetic anesthesia device.
15939615|NCT03344497|Other|VC Group|VC (Conventional Consultation/Video) Group
15939616|NCT03344484|Other|Surgical approach|Comparison of 2 surgical approaches used to treat degenerative spondylolisthesis via one- and two-level fusion
15939617|NCT03344471|Other|Passation of questionnaires|Specific questionnaires (Perinatal PTSD Questionnaire evaluating the Post-Traumatic Stress Disorder) and (NEO-FFI evaluating personality)
15939618|NCT03344458|Drug|TransCon hGH|Once weekly subcutaneous injection of TransCon hGH
15939619|NCT03344445|Other|video-assisted pre anesthesia explain|Anesthesiologist will visit all study patients, and only the experimental group will read the video.
15939620|NCT03344432|Diagnostic Test|with intraocular pressure high|Measurement of intraocular pressure The measurement will be made with a electronic minimum contact tonometer for measuring intraocular pressure immediately before the placement of the invasive catheter for measurement of intracranial pressure.
15939621|NCT03344432|Diagnostic Test|without intraocular pressure high|Measurement of intraocular pressure The measurement will be made with a electronic minimum contact tonometer for measuring intraocular pressure immediately before the placement of the invasive catheter for measurement of intracranial pressure.
15939622|NCT03344419|Drug|CI-581a|Medication infusion intravenously over 1 hour.
15939623|NCT03344419|Drug|CI-581b|Medication infusion intravenously over 1 hour.
15939624|NCT03344419|Behavioral|Motivational Enhancement Therapy (MET)|Manualized one on one therapy aimed at mobilizing motivation for change and for goals.
15939625|NCT03344419|Behavioral|Mindfulness Based Relapse Prevention|Manualized one on one therapy aimed at mindfulness-based behavioral modification and the cultivation of relapse prevention skils.
15939626|NCT03344406|Other|Telephonic interviews|Qualitative concept elicitation telephone interviews will be conducted in subjects with asthma.
15939627|NCT03344406|Other|E-RS: COPD|E-RS questionnaire will directly measure respiratory symptom severity.
15939628|NCT03344406|Other|Supplemental asthma items|Supplemental asthma items will include one question on wheeze and an item on breathlessness with activities to evaluate shortness of breath associated with strenuous activities.
15939629|NCT03344406|Other|Daily diary|Subjects will complete a daily diary including the E-RS: COPD and supplemental asthma items for 7 days.
15939630|NCT03344406|Other|Sociodemographic questionnaire|Sociodemographic questionnaire will capture subject's demographic characteristics, including age, gender, and the highest level of educational attainment.
15939631|NCT03344406|Other|Clinical questionnaire|Clinical questionnaire will capture subject's clinical characteristics including the number of asthma exacerbations in the past 12 months, absenteeism due to asthma in the past month, and the presence of comorbid conditions.
15939632|NCT03344393|Drug|Ketamine Hydrochloride|intravenous ketamine infusion intraoperatively
15939633|NCT03344393|Drug|Normal saline|intravenous normal saline infusion intraoperatively
15939634|NCT03344367|Biological|JWCAR029|Subjects will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JWCAR029. During JWCAR029 production, subjects will receive a conditioning chemotherapy regimen of cyclophosphamide and fludarabine for the purpose of lymphocytes depletion. After lymphodepletion, subjects will receive one dose treatment with JWCAR029 by intravenous (IV) injection.
15939635|NCT03344354|Device|Biogel 1|All study surgical gloves will be used during surgical procedures.
15939636|NCT03344354|Device|Ansell|All study surgical gloves will be used during surgical procedures.
15939637|NCT03344354|Device|Cardinal|All study surgical gloves will be used during surgical procedures.
15939638|NCT03344354|Device|Biogel 2|All study surgical gloves will be used during surgical procedures.
15939639|NCT03344354|Device|Medline|All study surgical gloves will be used during surgical procedures.
15939640|NCT03344341|Drug|Dapagliflozin|Starting dose of dapagliflozin is 5 mg once daily, taken orally in the morning, before or after breakfast. From the third week,the dose can be increased to 10 mg once daily, and last to the end of the study.
15939641|NCT03344341|Drug|Acarbose|Acarbose was started from 50 mg once a day at dinner during the first week and titrated up to 50 mg twice a day at lunch and dinner in the second week, 50 mg three times a day at three meals in the third week, and 100 mg three times a day till the end of the study.
15939642|NCT03344328|Drug|Bortezomib|The algorithm (computer query) will identify all patients who received bortezomib-based chemotherapy for the multiple myeloma indication between 2008 and 2016. All the questionnaires used are validated in the scientific literature.
15939643|NCT03344315|Device|experimental: collagen matrix|Mucograft collagen matrix combined with coronal advanced flap
15939644|NCT03344315|Other|Active Comparator: autologous connective tissue graft|Soft tissue harvesting from patient palate with coronal advanced flap
15939645|NCT03344302|Drug|Oxytocin|intravenous infusion of oxytocin 30 units over 5 minutes diluted into 500 mL of normal 0.9% sodium chloride
15939646|NCT03344289|Diagnostic Test|Colonoscopy|Participants will be randomized towards colonoscopy withdrawal with either LCI or HD-WLE
15939647|NCT03344276|Diagnostic Test|Neurocognitive Assessments|Patients will undergo carotid artery stenting for 50-70% carotid artery stenosis. Prior to surgery patients will undergo a battery of neurocogntive assessments 1 month and 2 months prior to surgery.
15939648|NCT03344276|Diagnostic Test|Measurements of inflammatory biomarkers|Patients will undergo carotid artery stenting for 50-70% carotid artery stenosis. After surgery, patients will undergo blood draws to measure for inflammatory biomarkers.
15939649|NCT03344276|Procedure|Carotid Artery Stenting|Patients will undergo carotid artery stenting for 50-70% carotid artery stenosis.
15939650|NCT03344263|Diagnostic Test|tests of attentional performance|tests of attentional performance before and after 6 months of continuous positive airways pressure
15939651|NCT03344250|Drug|EGFR BATs with TMZ following SOC RT/TMZ|Standard of care: 6 weeks of RT and TMZ and 6 cycles of TMZ (150-200 mg/m2) on days 1-5 of each 28 day cycle Experimental: EGFR BATs 2 and 3 weeks after completing RT, and then on day 21 of each cycle of TMZ.
15939844|NCT03342664|Device|Artemis + Medical Management|Subject will receive best MM in addition to the MIS procedure with Artemis.
15939657|NCT03344198|Behavioral|Circuit Training exercise & Modified Mediterranean diet|Participants will receive circuit training program and a modified Mediterranean diet program. Educational sessions, serving size training, and portion containers will be provided. Participants will also receive individualized support throughout the 6 week intervention.
15939658|NCT03344185|Dietary Supplement|Low Glycaemic Diet|This intervention consisted of three low GI meals.
15939659|NCT03344185|Dietary Supplement|High Glycaemic Diet|This intervention consisted of three meals, all with a high GI value.
15939660|NCT03344172|Drug|Gemcitabine, Nab-Paclitaxel, hydroxychloroquine and Avelumab|Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery Day 1 of Cycle 3: avelumab (10mg/kg)
15939661|NCT03344172|Drug|Gemcitabine, Nab-Paclitaxel, and hydroxychloroquine|Days 1, 8, 15 of Cycles 1 and 2: gemcitabine (1000mg/m^2) and nab-paclitaxel (125mg/m^2) Beginning on Day 8 of Cycle 1: hydroxychloroquine (600mg/BID) daily until day of surgery
15939662|NCT03344159|Drug|Spironolactone|Spironolactone 12.5mg daily up to a maximum dose of 50 mg daily if tolerated for a total duration of 12 weeks.
15939663|NCT03344159|Drug|Placebo|Placebo daily for a total of duration of 12 weeks
15939664|NCT03344159|Radiation|PET/CT Scan: Two PET scans using 1. C-11 HED and 2. N-13 Ammonia or rubidium-82|At baseline and 12 weeks, all participants will undergo rest perfusion PET imaging according to standard protocols with either 82-Rb or N-13 NH3, followed by C-11 HED PET.
15939665|NCT03344159|Diagnostic Test|Cardiac MRI (Gadolinium enhanced)|At baseline and 12 weeks all participants will undergo cMR to assess RV function and structure. We will acquire precontrast T2 and native T1 maps, and post gadolinium T1 maps.
15939666|NCT03344146|Behavioral|Medication intake reminders|Acoustic and visual alarm at predefined DOAC-intake timepoints.
15939667|NCT03344146|Behavioral|Pillbox use and counselling|All patients will be counselled based on their previous electronically recorded adherence data and will be given a multicompartment pillbox für daily use
15939668|NCT03344133|Behavioral|Exercise|4-week moderate intensity exercise programme
15939669|NCT03344120|Other|Administration of USSQ Symptoms questionnaire after stent positioning|Administration of USSQ Symptoms questionnaire to patients with two different type of stents after ureteroscopy
15939670|NCT03344107|Other|USSQ questionnaire administration after RIRS.|USSQ symptoms questionnaire administration after RIRS
15939671|NCT03344094|Drug|ocrelizumab|FDA-approved MS drugs
15939672|NCT03344068|Radiation|Radiotherapy|Intensity Modulated Radiation Therapy, Dose: GTVnx 6810cGy/30Fr, GTVnd 6400-6600cGy/30Fr, CTV1 6000cGy, CTV2 5400cGy.
15939673|NCT03344068|Drug|Chemotherapy|Nedaplatin 80mg/m2 d1+5-fluouracil 500mg/m2 d2-5, every 3 weeks; a total of 2-3 cycles.
15939674|NCT03344068|Dietary Supplement|Nutren® Optimum|Nutren® Optimum, 7 scoops each time, three times a day, at begin of radiotherapy
15939675|NCT03344055|Device|Endocuff Vision (ECV) second generation|"Colonoscopy performed with the use of Endocuff Vision (ECV) second generation at the tip of the scope"
15939676|NCT03344042|Drug|Fentanyl|100mcg Fentanyl
15939677|NCT03344042|Drug|Sufentanil|10mcg sufentanil
15939678|NCT03344029|Biological|SP Shz TIV|0.5 mL, intramuscular into the deltoid muscle, single injection on Day 0
15939679|NCT03344029|Biological|Hualan TIV|0.5 mL, intramuscular into the deltoid muscle, single injection on Day 0
15939680|NCT03344016|Other|Contact by clinical center|Patients will be acitvely contacted by the clinical center for follow-up procedure
15939681|NCT03344003|Drug|Wilate or Nuwiq|Wilate or Nuwiq administered via intravenous injection
15939682|NCT03343990|Procedure|Interlocking multi-twisted wires in sternal closure|One of many ways in cloure of sternal give more stabilization. At least 6 wires have to be passed. The wirs should run around the sternum in the intercostals spaces except in the manubrium where it has to be passed through the bone . Adjacent wires on the surgeon's side are wrapped around each other. The wires on the surgeon's side are then pulled towards the assistant so that the sternum is re-approximated. Alternatively the surgeon can also pull the wires at the assistant's side towards himself or herself approximating the sternum. Adjacent wires on the assistant's side are then wrapped around each other. The wrapped wires on both sides are then wrapped around each other The wrapped wires are then twisted around with a twister, closing the sternum tightly and the ends of the are burried
15939683|NCT03343990|Procedure|Eight Figure techniqe in sternal closure|The figure-eight closure is described as faster, simpler, and more reliable than its trans-sternal counterpart; with only oblique forces sutures are less likely to loosen or fracture the sternum. The advantage of figure-eight closure is that it allows oblique and horizontal angle of shearing forces instead of direct perpendicular forces. Thus these wires are less likely to loosen or fracture
15939684|NCT03343977|Drug|docetaxel 50mg/m2|50 mg/m2 of docetaxel will be given on day 1 every 14 days
15939685|NCT03343977|Drug|docetaxel 75mg/m2|75 mg/m2 of docetaxel will be given on day 1 every 21 days
15939686|NCT03343964|Diagnostic Test|Amplitude-integrated electroencephalography|Amplitude-integrated EEG (aEEG) is a compressed form of real-time conventional EEG monitoring that will be added to cEEG monitoring.
15939687|NCT03343951|Other|Examination|"Patients will be examined twice the same day by an extended scope physiotherapist (ESP) and an orthopaedic surgeon (OS) in random order. They will independently and blinded to each other's opinion register
~diagnosis and treatment plan (including need for further diagnostic examinations - i.e. imaging)
~if the patient needs a new appointment at the shoulder clinic
~if they under usual conditions would discuss their results with the opposite health professional before deciding diagnosis and treatment plan.
~After the individual examinations the ESP and OS discuss their results and come to an agreement (common decision) regarding the patient's diagnosis, treatment plan and need of a new appointment. Patients will be informed only of the common decision of the ESP and OS."
15939688|NCT03343938|Other|Embryo handling in a closed station|Embryo handling is performed inside a closed station with a controlled environment: 6% CO2 and 37 degrees.
15939689|NCT03343912|Drug|Estriol 0.400 mg/day and Trimegestone 0.06 mg/day|Vaginal ring with a nominal delivery rate of 0.400 mg/d estriol (E3) and 0.06 mg/d trimegestone (TMG), vaginal application
15939690|NCT03343912|Drug|Estriol 0.300 mg/day and Trimegestone 0.12 mg/day|Vaginal ring with a nominal delivery rate of 0.300 mg/d estriol (E3) and 0.12 mg/d trimegestone (TMG), vaginal application
15939883|NCT03342417|Biological|Ipilimumab|Ipilimumab 1 mg/kg administered by IV infusion over 30 minutes.
15939691|NCT03343912|Drug|Estriol 0.200 mg/day and Trimegestone 0.18 mg/day|Vaginal ring with a nominal delivery rate of 0.200 mg/d estriol (E3) and 0.18 mg/d trimegestone (TMG), vaginal application
15939692|NCT03343873|Drug|Midazolam|Midazolam was administered intravenously at a dose of 0.1 mg / kg followed by continuous intravenous injection at 0.03 mg / kg / h and maintained until the course of the scan.
15939693|NCT03343873|Drug|Propofol|Propofol group 1mg / kg intravenous injection, followed by 2mg / kg / h continuous intravenous injection, and maintained to the scanning process;
15939694|NCT03343873|Drug|Dexmedetomidine|Dexmedetomidine group with total amount of 1μg / kg, infusion time 15min, followed by 0.6μg / kg / h, and maintained to the scanning process;
15939695|NCT03343860|Procedure|AT case 1.1|"In the case of AT at the time of ablation :
~In the case of sinus rhythm restoration, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Inducibility will be tested but no ablation will be carried out and a DCC post AT mapping will be performed if necessary. The procedure will end up after these steps."
15939696|NCT03343860|Procedure|AT case 2.1|"In the case of AT at the time of ablation :
~In the case of sinus rhythm restoration, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Then inducibility will be tested and all inducible AT will be mapped and ablated (max 5 consecutive AT)"
15939697|NCT03343860|Procedure|AT case 1.2|"In the case of AT at the time of ablation :
~In the case of termination to another AT, a DCC will be performed. Thereafter, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Inducibility will be tested but no ablation will be carried out and a DCC post AT mapping will be performed if necessary. The procedure will end up after these steps."
15939698|NCT03343860|Procedure|AT case 1.3|"In the case of AT at the time of ablation :
~In the case of AF deterioration, a DCC will be performed. Thereafter, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Inducibility will be tested but no ablation will be carried out and a DCC post AT mapping will be performed if necessary. The procedure will end up after these steps"
15939699|NCT03343860|Procedure|AT case 1.4|"In the case of AT at the time of ablation :
~In the case of no AT termination, a DCC will be performed. Thereafter, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Inducibility will be tested but no ablation will be carried out and a DCC post AT mapping will be performed if necessary. The procedure will end up after these steps."
15939700|NCT03343860|Procedure|AT case 2.2|"In the case of AT at the time of ablation :
~In the case of termination to another AT, ablation of the subsequent AT will be performed until sinus rhythm restoration. Thereafter, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Then inducibility will be tested and all inducible AT will be mapped and ablated (max 5 consecutive AT)"
15939701|NCT03343860|Procedure|AT case 2.3|"In the case of AT at the time of ablation :
~In the case of AF deterioration, a DCC will be performed. Thereafter, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Then inducibility will be tested and all inducible AT will be mapped and ablated (max 5 consecutive AT)"
15939702|NCT03343860|Procedure|AT case 2.4|"In the case of AT at the time of ablation :
~In the case of no AT termination, a DCC will be performed. Thereafter, PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. Then inducibility will be tested and all inducible AT will be mapped and ablated (max 5 consecutive AT)"
15939703|NCT03343860|Procedure|SR Case 1|"In the case of SR at the time of ablation:
~PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. The CTI line will be performed in all patients with a ECG showing a typical counterclockwise flutter. Inducibility will be tested but no ablation will be carried out and a DCC post AT mapping will be performed if necessary. The procedure will end up after these steps."
15939704|NCT03343860|Procedure|SR Case 2|"In the case of SR at the time of ablation:
~PV will be re-isolated if necessary and lines (CTI, roof and mitral) already blocked during the first procedure will be re-blocked if necessary. The CTI line will be performed in all patients with a ECG showing a typical counterclockwise flutter. Then inducibility will be tested and all inducible AT will be mapped and ablated (max 10 consecutive AT)"
15939705|NCT03343847|Biological|Romiplostim|This trial is designed to study romiplostim for the treatment of chemotherapy-induced thrombocytopenia (CIT) in patients receiving chemotherapy for the treatment of lymphoma.
15939706|NCT03343847|Other|Placebo|Placebo Comparator
15939708|NCT03343821|Other|Balance and daily life questionnaire|Patients complete questionnaire
15939709|NCT03343808|Procedure|cooled radiofrequency ablation of genicular nerves|Cooled RF consists of creating an injury in the nerve trough a high frequency flow. Unlike conventional RF, in cooled RF through a closed circuit where intravenous flows, we can create an injury for a longer period of time, at a lower temperature (standard RFA 90º C, cooled RFA 60º C) and within an area 8 times larger. As the lesion is spherical, and larger (about 10-12 mm in diameter), the chances of neurolysis of the nerve increase.
15939710|NCT03343795|Drug|oral progesterone|daily
15939711|NCT03343795|Drug|intramuscular progesterone|every week
15939712|NCT03343782|Combination Product|Expanded autologous bone marrow-derived mesenchymal stem cell|Collect bone marrow from lilac crest using local anaesthetic and syringe collection. Mesenchymal stem cell will be isolated, expanded and characterized in vitro under the GMP- grade procedure
15939713|NCT03343769|Other|BERG scale|Complete the BERG balance scale
15939714|NCT03343769|Other|Functional tests|timed up and go, Mini motor test, retropulsion test
15939715|NCT03343769|Other|Measurement of balance on a force platform|4 trials of 30 seconds x 2 conditions (eyes open; eyes closed)
15939716|NCT03343769|Other|Measurement of maximal moment of the plantar flexor and dorsiflexor muscles|5-second repetitions
15939717|NCT03343769|Other|Measurement of the moment of the plantar flexors and dorsiflexors corresponding to RMS activity during balance measurements|3 10-second repetitions
15939718|NCT03343743|Other|Oligomineral water|Patients were instructed to drink at least 2 L/day of a hypotonic, oligomineral water low in sodium and minerals (fixed residue at 180°C <200 mg/L) for at least 12 months
15939719|NCT03343730|Diagnostic Test|Non-mydriatic color fundus photography with the RetinaVue camera|This hand-held device allows the primary care physician to capture an image of the patient's retina and transmit the image to a board-certified ophthalmologist for interpretation.
15939720|NCT03343730|Diagnostic Test|Referral for dilated eye exam with an eye care professional|All patients will be given a referral to an eye care professional for a routine, dilated, diabetic eye exam.
15939721|NCT03343717|Other|Rehabilitation|physical therapy exercise
15939722|NCT03343717|Other|Chest physical therapy|chest physical therapy exercise
15939723|NCT03343704|Drug|Idarucizumab|Intravenous
15939724|NCT03343691|Diagnostic Test|Screening Population|Blood samples taken from screening population
15939725|NCT03343691|Diagnostic Test|Breast Cancer Population|Blood samples taken from Breast Cancer population
15939726|NCT03343678|Drug|Venetoclax|Venetoclax given alone and then in combination with BI 836826
15939727|NCT03343678|Drug|BI 836826|Venetoclax given in combination with BI 836826
15939728|NCT03343665|Drug|Nivolumab 40 mg in 4 ml Injection|40 mg by intravenous (IV) infusion on day 1 Duration of cycle 14 days
15939729|NCT03343652|Drug|Nivolumab|3 mg/kg IV infusion on day 1,14 up to 3 cycles
15939730|NCT03343652|Drug|Bendamustine Hydrochloride|90 mg/kg IV infusion on day 1 up to 3 cycles
15939731|NCT03343639|Drug|5 mg Serlopitant Tablets|Serlopitant Tablets
15939732|NCT03343639|Drug|Matching Placebo Tablets|Placebo Tablets
15939733|NCT03343626|Drug|Placebo|PIZV placebo-matching saline solution.
15939734|NCT03343626|Biological|PIZV|Purified inactivated Zika virus vaccine with aluminum hydroxide adjuvant.
15939735|NCT03343613|Drug|LY3381916|IDO-1 inhibitor administered orally
15939736|NCT03343613|Drug|LY3300054|PD-L1 inhibitor administered IV
15939737|NCT03343600|Drug|Imatinib|Imatinib 100 mg/tablet, 2 tablets daily
15939738|NCT03343600|Drug|Placebo|Placebos 2 tablets daily
15939739|NCT03343587|Drug|LY3375880 IV|administered IV
15939740|NCT03343587|Drug|LY3375880 SC|administered SC
15939741|NCT03343587|Drug|Placebo IV|administered IV
15939742|NCT03343587|Drug|Placebo SC|administered SC
15939743|NCT03343574|Other|Abdominal Strengthening Exercise|Abdominal strengthening exercises involve the muscles of the abdomen. These exercises are to be done in different positions like lying down (recumbent) position, sitting and standing positions. The person performing the exercise contracts the abdominal muscles for a predetermined number of times (up to 10 times), holds the contracted position for up to 10 seconds and then releases the contraction to relax and return to the original state. These exercises are done for three times everyday.
15939744|NCT03343561|Behavioral|Nutrition Advice|Intervention diet for 8 weeks for intervention group. Detailed 30 mins consultation in week 1 (provided by dietitian) and 15 min consultation (provided by RA) in week 4 to enhance subject adherence to the diet for intervention group. Control group subjects will receive 1 detailed 30 mins nutrition consultation from dietitian after the study.
15939745|NCT03343548|Drug|magnesium sulfate|2cc of magnesium sulfate ( 50%) will be administered epidurally
15939746|NCT03343548|Drug|normal saline|2cc of normal saline will be administered epidurally
15939747|NCT03343535|Device|OCS Lung Preservation|OCS Lung Preservation
15939748|NCT03343522|Behavioral|Exercise|A multimodal exercise training program (aerobic, strength and flexibility exercises) for 6 months (60-min sessions performed 3 times/week with moderate intensity).
15939749|NCT03343509|Drug|Metronidazole Oral|Oral Metronidazole
15939750|NCT03343509|Drug|Metronidazole Ointment|Metronidazole Ointment
15939751|NCT03343509|Drug|Placebo Oral Tablet|Placebo Tablet
15939752|NCT03343509|Drug|Placebo Ointment|Placebo Ointment
15939753|NCT03343496|Procedure|Awake fiberoptic intubation (AFOI)|With forty patients (ASA I~II, aged 18~75, simulating cervical instability injury) recruited to be operated on under general anesthesia, two experienced anesthesiologists performed the whole procedures within the study. Pre anesthetic interview was taken to illustrate the procedures of tracheal intubation to the patients. The simplified method consisted of three parts: conscious sedation, regional anesthesia and intubation. The time of AFOI, rate of one-time intubation success, hemodynamic parameters, pulse oxygen saturation (SpO2), rate of amnesia of the intubation, patients' satisfaction, and relative complications were recorded accordingly.
15939754|NCT03343483|Behavioral|Volunteering|"Volunteers provide non-medical caregiving for frail seniors-care receivers-to help them maintain their independence and improve their well-being. Friendly visiting is the primary service provided. Structured, intensive training is provided prior to placement. The target expectation is of interactions in person and/or by telephone for at least 16 hours per month. On-going training (booster sessions) as well as volunteer support groups, and educational activities are provided. Participants not interested in serving as peer companions are allowed other volunteer options as long as the activities are deemed 'social' by the volunteer coordinator and are options routinely provided as part of the AmeriCorps Senior RSVP Program. COVID update: due to physical distancing requirements, volunteer placements have transitioned to remote friendly calling/letter writing or activities that can be conducted with physical distancing, such as delivery for Meals on Wheels."
15939755|NCT03343483|Behavioral|Life Review|Subjects will complete a self-guided life review exercise over 12 months. Subjects will complete one section of the life review (with the self-help book) each month and send 'assignments' once per month to an email 'counselor' who will respond with supportive comments within three days.
15939756|NCT03343457|Behavioral|Cognitive therapy|
15939757|NCT03343444|Drug|12 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)|Single Tablet (Sofosbuvir 400mg/Ledipasvir 90mg) daily for 12 weeks
15939758|NCT03343444|Drug|8 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)|Single Tablet (Sofosbuvir 400mg/Ledipasvir 90mg) daily for 8 weeks
15939759|NCT03343431|Drug|Anti-HBV antiviral prophylaxis|Tenofovir disoproxil fumarate (TDF), one 300 mg tablet once a day from 28 weeks' gestation through two months postpartum
15940178|NCT03340116|Procedure|Burn surgery|Burn surgery including wound debridement, skin grafting
15939760|NCT03343418|Drug|Desmopressin|Desmopressin is to be administered as an intravenous infusion after discontinuation of cardiopulmonary bypass and administration of protamine. Subjects are to be given desmopressin 0,3 microgram.kg-1. After desmopressin infusion, bleeding treatment will follow the predefined standardized treatment regimen.
15939761|NCT03343418|Drug|Placebo|0.9% saline is to be administered as an intravenous infusion after discontinuation of cardiopulmonary bypass and administration of protamine. Patients randomized to the control group will receive the infusion of 100 milliliters (mL) 0.9% saline (SF0,9%). After 0.9% saline infusion, bleeding treatment will follow the predefined standardized treatment regimen.
15939762|NCT03343405|Behavioral|Online Mind/Body Program for Fertility|The Mind/Body intervention involves (1) reducing physical symptoms of stress, (2) enhancing lifestyle behaviors related to fertility, (4) self-nurturing and coping skills, and (5) relaxation methods.
15939763|NCT03343392|Drug|acetam/ketoro tromet group|One hour before in-office bleaching patients received either the acetaminophen 750 mg (Paracetamol 750 mg, Bioativa compounding pharmacy) and ketorolac tromethamine oral 10 mg (Toragesic® 10 mg, EMS Sigma Farma). The operator administered the first dose of drug 1 h before the protocol, and extra doses were administered every 8 h for 48 h to keep a safe maximum daily dosage of 4000 mg of acetaminophen and 40 mg of ketorolac tromethamine.
15939764|NCT03343392|Drug|Placebo group|One hour before in-office bleaching patients received either placebo,The operator administered the first dose of drug 1 h before the protocol, and extra doses were administered every 8 h for 48 h.
15939765|NCT03343379|Other|Core stability tests|A test battery comprised of field tests to evaluate core stability
15939766|NCT03343366|Drug|Metronidazole|Systemic AAT would contain Metronidazole (MET) 400 mg x 3 for 10 days
15939767|NCT03343366|Procedure|Scaling Root Planing|SRP will be performed using ultrasonic scaling device at medium intensity. In addition to ultrasonic scalar, hand instrumentation (using sharpened and sterilized curettes) may also be used if required to smoothen certain irregular areas of root surface until the surfaces are smooth.
15939768|NCT03343366|Behavioral|Oral Hygiene Instructions|OHI would include brushing teeth using soft bristles toothbrush and fluoridated toothpaste twice daily (morning after breakfast and night before sleeping) using Modified Bass Technique.
15939769|NCT03343353|Other|LED (Light Emission Diode)|LED light application in cutaneous lesions from the graft donor area (scalp) in patients who are victims of burns
15939770|NCT03343340|Other|Early CRRT|Continous Renal Replacement Therapy
15939771|NCT03343340|Other|Late CRRT|Continous Renal Replacement Therapy
15939772|NCT03343340|Other|Standard Medical Therapy|Standard Medical Therapy
15939773|NCT03343327|Drug|Chronocort®|Single dose of 20mg Chronocort® administered in one treatment period
15939774|NCT03343327|Drug|Cortef®|Single dose of 20mg Cortef® administered in one treatment period
15939775|NCT03343301|Combination Product|FPA144 + mFOLFOX6|Dose escalation of FPA144 to identify recommended dose in combination with mFOLFOX6
15939776|NCT03343288|Device|Silver doped hydroxyapatite coated implants|In this study, CE marked, domestic manufactured standard orthopedic implants will be used in 30 patients after silver ceramic coating with electrospray method. These patients will be tasted for the evaluation of liver and kidney functions and blood and urine silver levels in addition to routine tests such as full blood, complete biochemistry, C-reactive protein, erythrocyte sedimentation rate required in the normal diagnosis and treatment processes, and will be monitored for at least 12 months.
15939777|NCT03343275|Combination Product|Lit control pHDown|Patients within the experimental arm will receive dietary supplement Lit-control®pH Down to help them keep their urinary pH in the adequate levels, being these considered as the preventive ones to avoid stent calcification (pH<6.2) being the 3 capsule per day indication. On the other hand, the control arm will receive a placebo product with similar organoleptic qualities and the same posology characteristics. Both arms wil use Lit-Control® pH Meter device to keep self- control of the urinary pH; also, both will receive the same hygienic-dietary indications about the care of the stent.
15939778|NCT03343262|Device|ta-VNS|The transcutaneous vagus nerve stimulation (taVNS) at auricular concha is a typical representative of TCM modernization. The taVNS regulates the autonomic nervous system, which shows a good therapeutic effect for the treatment of IGT.
15939779|NCT03343262|Other|Electro-acupuncture|one of the most common acupuncture methods, selecting acupoints based on traditional Chinese medicine theory. It exerts the function to regulate qi and blood circulation and balance Yang and Yin energy inside body.
15939780|NCT03343249|Behavioral|Smart Phone Based Smoking Cessation|The Samsung Galaxy Light Smart phone uses the Android 4.2 operating system. The phone has a 4.0 inch (480x800-pixel resolution) touch screen display, a built in microphone, earphone jack, audio speaker, and a rechargeable battery with 12.5 hours of talk time. The phone has 4G and is Wi-Fi and GPS capable. Participants navigate through the EMA program and enter data simply by touching the screen, similar to a pen-and-paper questionnaire. Thus, computer/typing skills are not required. Participants have the ability to call and receive calls from research staff through the smart phone free of charge. All phones will be equipped with Global Positioning Systems (GPS) capability. The smart phones are also equipped with a Secure Digital card to store data as it is collected.
15939782|NCT03343223|Behavioral|Intervention Group|"The goal of this research study is to evaluate the preliminary impact of a public-health-partnered tele-pharmacist model for pre-exposure prophylaxis (PrEP) delivery in a rural state (TelePrEP). In brief, PrEP involves daily use of a medication (i.e. Truvada) to prevent HIV infection among people at risk for infection due to sexual exposure or needle sharing."
15939783|NCT03343210|Diagnostic Test|quality of life and pain measurement .|comparison of quality of life measurement in residents with cancer and in cancer-free residents, by a geriatric consultations'nurse
15939784|NCT03343197|Drug|AG-120|Prior to surgery subjects will receive AG-120 administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects without residual disease following surgery will have the option to receive treatment for up to a year, until disease progression or unacceptable toxicity, whichever occurs first. Subjects with residual disease following surgery will have the option to receive treatment, until disease progression or unacceptable toxicity.
15976791|NCT03061058|Drug|Cisplatin|intraperitoneal
15939785|NCT03343197|Drug|AG881|Prior to surgery subjects will receive AG-881 administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects without residual disease following surgery will have the option to receive treatment for up to a year, until disease progression or unacceptable toxicity, whichever occurs first. Subjects with residual disease following surgery will have the option to receive treatment, until disease progression or unacceptable toxicity.
15939786|NCT03343184|Procedure|SEE Strategy and Incremental Restoration|37% phosphoric acid will be applied during 30 seconds, only in enamel in 50 teeth. This acid will be removed using water, the cavity will be air-dried, and then, the adhesive will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and photoactivated during 10 seconds with Light Emission Diode (LED) light. Then, the Filtek Z350XT composite will be used in increments of no more than 2 mm, using the incremental restoration technique, and each increment will be photoactivated for 40 seconds.
15939787|NCT03343184|Procedure|SEE Strategy and Bulk Fill Restoration|37% phosphoric acid will be applied during 30 seconds, only in enamel in 50 teeth. This acid will be removed using water, the cavity will be air-dried, and then, the adhesive will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and photoactivated during 10 seconds with Light Emission Diode (LED) light. Then, the Filtek Bulk Fill composite will be used in increments of 4 mm, using the bulk restoration technique, and photoactivated for 40 seconds.
15939788|NCT03343184|Procedure|SET Strategy and Incremental Restoration|no conditioning, the adhesive system will be used in 50 teeth, according to the manufacturer's instructions, in the self-etching mode. The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and photoactivated during 10 seconds with Light Emission Diode (LED) light. Then, the Filtek Z350XT composite will be used in increments of no more than 2 mm, using the incremental restoration technique, and each increment will be photoactivated for 40 seconds.
15939789|NCT03343184|Procedure|SET Strategy and Bulk Fill Restoration|no conditioning, the adhesive system will be used in 50 teeth, according to the manufacturer's instructions, in the self-etching mode. The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and photoactivated during 10 seconds with Light Emission Diode (LED) light. Then, the Filtek Bulk Fill composite will be used in increments of 4 mm, using the bulk restoration technique, and photoactivated for 40 seconds.
15939790|NCT03343145|Biological|Leucostim 5µg/kg/day|5µg/kg/day (based on actual body weight) Leucostim®, subcutaneously, once a day, for up to 14 days or until the target ANC of 10,000/mm3 following the expected chemotherapy-induced ANC nadir
15939791|NCT03343145|Biological|Neupogen 5µg/kg/day|5µg/kg/day (based on actual body weight) Neupogen®, subcutaneously, once a day, for up to 14 days or until the target ANC of 10,000/mm3 following the expected chemotherapy-induced ANC nadir
15939792|NCT03343132|Behavioral|Standard locomotor therapy|Typical clinical therapy.
15939793|NCT03343106|Behavioral|ACT plus ERP|16 twice-weekly sessions of 120-minute individual psychotherapy consisting of Acceptance and Commitment Therapy plus Exposure and Response Prevention (ACT plus ERP).
15939794|NCT03343106|Behavioral|ERP alone|16 twice-weekly sessions of 120-minute individual psychotherapy consisting of Exposure and Response Prevention (ERP alone) monotherapy.
15939795|NCT03343093|Behavioral|Restore Rehabilitation Program|Multi-component, structured, biopsychosocial, online interactive program to address the sexual and urinary effects of prostate cancer treatment
15939796|NCT03343093|Behavioral|Control|usual care, surveys every 3 months
15939797|NCT03343080|Drug|1.8% lidocaine plus 0.76% sodium bicarbonate|At the time of intubation, the endotracheal tube cuff will be inflated with a solution containing 1.8% lidocaine plus 0.76% sodium bicarbonate until loss of air leak at a positive pressure of 20 cm of water. This solution will remain in situ through the duration of cardiac surgery, transportation to the intensive care unit, and continued to the time of extubation.
15939798|NCT03343080|Other|Air|At the time of intubation, the endotracheal tube cuff will be inflated with air until loss of air leak at a positive pressure of 20 cm of water. The air will remain in situ through the duration of cardiac surgery, transportation to the intensive care unit, and continued to the time of extubation.
15939799|NCT03343067|Drug|elagolix|Tablets
15939800|NCT03343067|Drug|estradiol/norethindrone acetate (E2/NETA)|Capsules
15939801|NCT03343054|Drug|talazoparib|Talazoparib will be administered orally on a continuous basis. Talazoparib may be taken with or without food. Each cycle will consist of 28 days.
15939802|NCT03343041|Dietary Supplement|low-carbohydrate nutrition|low-carbohydrate enteral nutrition
15939803|NCT03343041|Dietary Supplement|Standard enteral nutrition|standard enteral nutrition
15939804|NCT03343028|Other|Psychotherapy|
15939805|NCT03343015|Procedure|complete dentures|therapy with maxilla and mandible dentures
15939806|NCT03343002|Drug|fentanyl at 10-15 min before end of surgery|Label 2 syringe is filled with 1mcg/kg of fentanyl, label 1 syringe is filled with same amount of saline solution. If the surgeon notifies the anesthesiologist 10-15 minutes before the end of the operation, the syringe drug labeled 1 will be administered intravenously(that is, normal saline ). At the end of the surgery, the syringe drug labeled 2 is administered intravenously((that is, 1mcg/kg of fentanyl)
15939807|NCT03343002|Drug|fentanyl at end of surgery|Label 2 syringe is filled with 1mcg/kg of fentanyl, label 1 syringe is filled with same amount of saline solution. If the surgeon notifies the anesthesiologist 10-15 minutes before the end of the operation, the syringe drug labeled 1 will be administered intravenously(that is, normal saline ). At the end of the surgery, the syringe drug labeled 2 is administered intravenously((that is, 1mcg/kg of fentanyl)
15939808|NCT03342989|Behavioral|Speed of Processing Training|This intervention is based on computer-administered tasks that are used to evaluate Useful Field of View test, which measures discrimination between visually presented stimuli in the presence of distractors
15939809|NCT03342989|Behavioral|Internet-Based Contact Control|This intervention provides social contact and mentally stimulating activities that do not target speed of processing
15939810|NCT03342976|Other|My-AHA platform|ICT strategy for early detection of frailties
15939811|NCT03342963|Drug|ASC-01|Aripiprazole 3 mg/sertraline 100 mg combination drug
15939812|NCT03342963|Drug|Aripiprazole and sertraline|Aripiprazole 3 mg and sertraline 100 mg
15939816|NCT03342924|Other|Flanker Test and physical fitness test|Socioeconomic status was determined using a trichotomous index. Inbody was used to assess body composition. To assess physical fitness, certain field tests were implemented using devices to quantify precise actions of physicality. Cognitive control was assessed using a computer-based Flanker Task.
15939817|NCT03342911|Drug|Paclitaxel|Given IV
15939818|NCT03342911|Drug|Carboplatin|Given IV
15939819|NCT03342911|Biological|Nivolumab|Given IV
15939820|NCT03342898|Biological|YF-17D|YF-17D SC injection.
15939821|NCT03342898|Biological|TDV|TDV SC injection.
15939822|NCT03342898|Drug|Placebo|Normal Saline (0.9% NaCl) SC injection.
15939823|NCT03342885|Behavioral|Specific sleep ergonomics guidance|Participants receive a detailed instruction in sleep ergonomics. Participants are instructed to maintain either side lying or supine sleeping posture, depending on which is less painful. Neutral position of spine supported by specific placement of body pillow. Changing of posture during sleep is prevented. The participants are recommended to replace their mattress if they feel that it is too hard or too soft. Instruction is given by a physiotherapist during one personal therapy session and the participants also receive a printed instruction.
15939824|NCT03342885|Behavioral|General sleep ergonomics guidance|Participants are instructed find most comfortable sleeping posture by personal preference and to avoid painful posture. The participants are recommended to replace their mattress if they feel that it is too hard or too soft. Instruction is given by a physiotherapist during one personal therapy session and the participants also receive a printed instruction.
15939825|NCT03342872|Behavioral|Core Training: FBS System Mapping and MTFS-I Installation|Core Training will be a blended strategy wherein multiple interventions targeting multiple agency roles are combined to help ASU treatment providers increase their FBS quality. Core Training will be conducted with administrators, supervisors, data managers, and clinical staff. It will contain two 3-hour sessions focusing on FBS System Mapping and MTFS-I Installation. FBS System Mapping will focus on process mapping of existing site policies and practices for assessing family functioning at intake, educating families about intervention strategies and activities, including family members in treatment sessions, and hiring and supporting clinicians trained in and routinely delivering FBS. MTFS-Installation will focus on introducing MTFS-I components and integrating principles of DDDM.
15939826|NCT03342872|Behavioral|Core Training & Facilitation: FBS System Mapping and MTFS-I Installation plus monthly on-site meetings|Facilitation will consist of monthly on-site meetings to review progress toward FBS improvements, discuss MTFS-I feedback reports and online resource use, and provide intensive technical assistance for progressing toward site-selected FBS improvement goals. Meetings will involve a subset of site-delegated participants from Core Training sessions to serve as a local change team (quality improvement team). The efficacy of facilitation-guided change teams has been established. Although there are several models for creating change teams, at least three features are common: (1) members represent multiple organizational roles (supervisors, data managers, line staff); (2) focus on data-driven decisions; and (3) use of external expert advisors.
15939827|NCT03342859|Drug|Vilaprisan, BAY1002670|Daily single oral doses of 2 mg vilaprisan over 8-12 weeks
15939828|NCT03342859|Drug|Ulipristal|Daily single oral doses of 5 mg ulipristal over 8-12 weeks
15939829|NCT03342846|Device|rTMS|the first group received 20 Hz and the 2nd group received 1 Hz rTMS daily for 10 days 5 sessions every week on M1.
15939830|NCT03342833|Device|Blood flow restriction|Occlusion of venous flow between bouts of HIIT training exercise
15939831|NCT03342820|Procedure|Muscle fatigue|Isokinetic quadriceps muscle fatigue of the paretic lower limb
15939832|NCT03342807|Drug|Insulin|Insulin infusion for subjects in Group Insulin.
15939833|NCT03342807|Device|Aphesis|Aphesis for subjects in Group Aphesis.
15939834|NCT03342794|Procedure|cataract surgery|To diagnose the preexisting posterior capsule defects in congenital cataracts after the cataracts are removed by surgery and observe the characteristics
15939835|NCT03342781|Device|high flow nasal oxygen therapy|Oxygen therapy using a high-flow nasal cannula (HFNC) is a high-flow oxygen delivery system that enhances the efficiency of respiration by using high flow rates to clear dead space and provide fresh oxygen. This system supplies oxygen at a high flow rate through a loose nasal cannula.
15939836|NCT03342781|Device|Diffuser oxygen mask|diffuser mask is a low-flow delivery system, which is capable of delivering up to 90% of the fraction of inspired oxygen (FiO2) with low CO2 retention. In this system, the FiO2 can be adjusted by modifying the flow velocity to deliver the quantity of oxygen that the patient requires. Oxygen is supplied to the patient in a jet that flows from a device mounted on the oxygen mask. This ensures that a high concentration of oxygen is provided at a low flow rate.
15939837|NCT03342768|Other|Smartphone-based messages|"For the TID arm, the messages' contents include the tobacco industry's (TI's) anti-smoking campaigns that made smoking more grown-up and more appealing to youth; the TI's role in smoking in movies; etc.
~For the sugar sweetened beverage (SSB) arm, the messages' contents include the disease conditions linked to SSBs, and the interference of sugar industry in scientific research."
15939838|NCT03342742|Behavioral|Weight Loss|Weight loss behavioral intervention via one of two strategies.
15939839|NCT03342729|Behavioral|Intervention|Participants receive the AMP 10-week program immediately
15939840|NCT03342729|Behavioral|Control|Participants will not received the AMP 10-week program immediately, rather will wait 3-months
15939841|NCT03342703|Diagnostic Test|Ultrasound|Patients will undergo a standard liver US protocol for approximately 15 minutes.
15939842|NCT03342690|Drug|Eplerenone|"In adults, usually, administer the initial dose of 25 mg once daily according to the patient's serum potassium level and conditions, increase dosage up to 50 mg once daily after 4 week; patients with moderate renal impairment should start with 25 mg every other day and the maximum dosage should be 25 mg once daily.
~Also, dose should be reduced or interrupted according to serum potassium level and patient's conditions."
15939843|NCT03342677|Diagnostic Test|Primovist MRI|Utility of Gd-EOB-DTPA (Primovist) enhanced Liver MRI in HCC detection and characterization in cirrhotic patients will be studied.
15940329|NCT03338868|Other|Body composition|evaluated by Bodystat®1500 Bio-impedance Analyzer
15939845|NCT03342664|Other|Best Medical Management Alone (MM)|Subject will receive best MM for ICH as determined by stroke physician following AHA/ESO guidelines.
15939846|NCT03342651|Other|Vitamin D|Vitamin D, general anesthesia, respiratory complications
15939847|NCT03342638|Drug|Cyclophosphamide|Potent immunosuppressive agent; an alkylating agent
15939848|NCT03342638|Drug|Mesna|Medication used to decrease the risk of hemorrhagic cystitis prophylaxis
15939849|NCT03342638|Drug|rATG|A predominantly lymphocyte-specific immunosuppressive agent which contains antibodies specific to the antigens commonly found on the surface of T cells
15939850|NCT03342638|Drug|Methylprednisolone|Steroid
15939851|NCT03342638|Drug|G-CSF|Granulocyte-colony stimulating factor; a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream
15939852|NCT03342638|Biological|IVIg|Sterile, purified immunoglobulin G (IgG) products manufactured from pooled human plasma and typically contain more than 95% unmodified IgG, which has intact Fc-dependent effector functions and only trace amounts of immunoglobulin A (IgA) or immunoglobulin M (IgM).
15939853|NCT03342638|Biological|Autologous Stem Cells|Infusion of participant's own stem cells
15939854|NCT03342625|Device|High Instensity Focused Ultrasound|High Intensity Focused Ultrasound guided by MRI
15939855|NCT03342612|Procedure|Brain Magnetic Resonance Imaging (MRI)|
15939856|NCT03342599|Dietary Supplement|Alpha Lipoic Acid Supplement|Alpha lipoic acid ingestion (600mg/daily) for 8 weeks with no change in lifestyle.
15939857|NCT03342599|Dietary Supplement|Placebo|Cellulose fiber ingestion (600mg/daily) for 8 weeks with no change in lifestyle.
15939863|NCT03342573|Drug|Cosentyx|Cosentyx 300 mg SQ week 0-4, then every q4 weeks for a total of 28 weeks.
15939864|NCT03342560|Device|Sonographic SWE measurements with 4 different ultrasound systems|Sonographic Shear wave elastography will be performed to quantify liver fibrosis
15939865|NCT03342547|Procedure|Duodenal biopsy|Two duodenal biopsy samples will be collected from each participant
15939866|NCT03342547|Procedure|Saliva|Saliva (1-2 mL) will be collected from each participant for secretor status testing
15939867|NCT03342534|Device|DC-stimulator (Neuroconn, Germany)|A current of 2 mA will be applied for 20 minutes, 3 times per week during 2 weeks, except for the sham tDCS arm.
15939868|NCT03342521|Diagnostic Test|optical coherence tomography and VerifyNow|optical coherence tomography Imaging P2Y12 and Aspirin reaction units quantification by the VerifyNow
15939869|NCT03342508|Device|Fetal Pillow|see arm description
15939870|NCT03342495|Other|Patient Navigator|Social worker/Patient Navigator will be assigned to follow youth in adult care for up to 24 months to assist youth adapt and attach to adult delivered healthcare
15939871|NCT03342495|Other|Usual Care|Whatever processes are in place in a variety of clinics to support transfer from pediatric to adult care in the pediatric clinics
15939872|NCT03342482|Other|Low-glutamate diet|The dietary intervention consists of a one-month low-glutamate diet, followed by a randomized crossover challenge with MSG and placebo to measure return of symptoms.
15939873|NCT03342469|Other|Artificial Food Coloring|225mg mixed powdered Artificial Food Coloring (AFC)
15939874|NCT03342469|Other|Placebo|Placebo chocolate cookies
15939875|NCT03342456|Drug|Doxycycline Hyclate Enteric-Coated Capsules|group 1,0.1g*10 capsules/box, produced by Yung Shin Pharm.Ind.(Kunshan) Co.,Ltd.
15939876|NCT03342456|Drug|Amoxicillin Capsules|group 2,0.5g*24 capsules/box, produced by United Laboratories（Zhuhai）
15939877|NCT03342456|Drug|Ilaprazole Enteric-Coated Tablets|group 1 and group 2,5mg*6 capsules/box, produced by Livzon Pharmaceutical Group Inc
15939878|NCT03342456|Drug|Furazolidone Tablets|group 1 and group 2,0.1g*100 tablets/bottle,produced by Shanxi Yunpeng Pharmaceutical co.,Ltd.
15939879|NCT03342456|Drug|Potassium Citrate Tablets|group 1 and group 2,110mg*40 tablets/bottle,produced by Livzon Pharmaceutical Group Inc
15939880|NCT03342443|Drug|Memantine|Patients receive memantine with a dosage of 5 microgram at 8 am daily for one week (Week 1), then 5 microgram at 8 am and 5 microgram at 5 pm for one week (Week 2), then 10 microgram at 8 am and 5 microgram at 5 pm for one week (Week 3), then 10 microgram at 8 am and 10 microgram at 5 pm for 21 weeks (Week 4-24), in the absence of unacceptable toxicity or severe deterioration.
15939881|NCT03342443|Drug|Placebo|Patients receive placebo with a dosage of one halfpill at 8 am daily for one week (Week 1), then one halfpillat 8 am andone half pill at 5 pm for one week (Week 2), then one pillat 8 am and one half pill at 5 pm for one week (Week 3), then one pill at 8 am and one pill at 5 pm for 21 weeks (Week 4-24), in the absence of unacceptable toxicity or severe deterioration.
15939882|NCT03342417|Biological|Nivolumab|Nivolumab 240 mg administered by IV infusion over 30 minutes
15939884|NCT03342404|Drug|Luspatercept|Subjects will start with luspatercept at 1 mg/kg dose level every 3 weeks and can be dose escalated up to 1.25 mg/kg.
15939885|NCT03342404|Other|Placebo|Placebo, Subcutaneous, every 21 days
15939886|NCT03342404|Other|Best Supportive Care (BSC)|Best Supportive Care (BSC)
15939887|NCT03342391|Other|Transnasal esophagoscopy|single food antigen introduction OR removal of topical swallowed steroid therapy followed by surveillance utilizing TNE
15939888|NCT03342378|Radiation|Intensity modulated radiotherapy (IMRT)|Intensity modulated radiotherapy (IMRT) will be delivered over 6.5 weeks in 33 daily fractions. Treatments will be initiated on Monday or Tuesday. Missed treatments will be compensated for by delivering an additional BID treatment during the week given at least 6 hours apart OR treating on the Saturday of that week, OR adding to the end of treatment. Gross disease will receive 70 Gy in 2.12 Gy fractions, areas at high-risk for subclinical disease will receive 60 Gy in 1.82 Gy fractions, and areas at low-risk for harboring subclinical disease will receive 56 Gy in 1.70 Gy fractions.
15939889|NCT03342378|Diagnostic Test|PET-MRI|All imaging data will be acquired using a 3.0T PET-MRI scanner with a standard bore size of 60 cm. Patients will be placed in standard non-ferrous head and neck immobilization devices during PET-MRI to simulate their anticipated positioning during subsequent CT simulation and treatment. A head and neck PET-MRI study will be performed with scan sequences tailored for the site of interest. The PET-MRI exam will take approximately 90 minutes to complete.
15939890|NCT03342365|Diagnostic Test|Evaluation of microbial translocation and microbiota|Blood test from catheter already in place to determine microbial translocation and stool sample taken for microbiota analysis
15939891|NCT03342352|Drug|Nivolumab|Nivolumab administered intravenously at the protocol-defined dose every 3 weeks.
15939892|NCT03342352|Drug|Epacadostat|Epacadostat administered orally at the protocol-defined dose twice daily.
15939893|NCT03342352|Drug|Placebo|Matching placebo for epacadostat administered orally twice daily.
15939894|NCT03342352|Drug|Carboplatin|Carboplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
15939895|NCT03342352|Drug|Cisplatin|Cisplatin administered intravenously at the protocol-defined dose every 3 weeks for 6 cycles.
15939896|NCT03342352|Drug|Cetuximab|Cetuximab administered intravenously at the protocol-defined dose weekly.
15939897|NCT03342352|Drug|5-Fluorouracil|5-Fluorouracil administered intravenously at the protocol-defined dose on Days 1-4 for 6 cycles.
15939898|NCT03342339|Other|cognitive examination|mini mental test of Parkinson, Hospital Anxiety and Depression Scale, 5 words by Dubois, fast test frontal assessment, Trail Making Test
15939899|NCT03342339|Other|viewing of video|viewing during 5 minutes scale of differential emotions and Positive and Negative Affect Scale
15939900|NCT03342339|Other|Iowa Gambling Task|Test of Iowa Gambling Task
15939901|NCT03342326|Other|Exposure to familiar songs|3 conditions : a) Words and Music (sing condition), b) Words only (spoken condition) and c) Music only (instrumental condition) After each song : rate the popularity of the song on a scale of 1 to 5.
15939902|NCT03342326|Other|Music Experience Questionnaire|questions about the past music training
15939903|NCT03342326|Other|Implicit tasks memory|"2 tests : a) Completion of trigrams : freely complete the first 3 letters of a word.
~b) lexical decision : judge whether an audibly presented sound sequence is a word existing in the French language or not."
15939904|NCT03342326|Other|Questionnaires|Mini Mental State Examination, 5 words by Dubois and fluence verbal test
15939905|NCT03342313|Other|Food - Sandwich|Sandwich as a breakfast for testing chewing activities.
15939906|NCT03342300|Drug|pegylated liposomal doxorubicin|Several efforts have been made to improve the toxicity profile of conventional anthracyclines, including the use of liposomal encapsulation technology,such as pegylated liposomal doxorubicin.
15939907|NCT03342300|Drug|pirarubicin|Another effort has been made to improve the toxicity profile of conventional anthracyclines is the development of novel anthracycline analogs,such as pirarubicin.
15939908|NCT03342287|Other|questionnaires|Questionnaires rating IBS symptoms, constipation, anxiety and depression
15939909|NCT03342287|Other|cognitive evaluation|Administration of online cognitive battery
15939910|NCT03342287|Other|Blood|Measurement of cytokines/inflammatory biomarkers
15939911|NCT03342287|Other|Fecal sample|Measurement of the gut microbiome
15939912|NCT03342274|Behavioral|Lifestyle Program|Participants will receive group weight loss sessions addressing healthy eating, exercise, and weight loss principles adapted from the Diabetes Prevention Program delivered by Community Health Workers.
15939913|NCT03342274|Other|Usual Care|Usual care consists of chronic disease management through medication delivery and monitoring of weight, blood pressure, and blood glucose by Community Health Workers.
15939914|NCT03342261|Drug|DAA treatment|Patients were treated with direct-acting antiviral (DAA) treatment for 12 or 24 weeks
15939915|NCT03342248|Other|access to the social network|The development of a social network via a digital platform for carers of patients suffering from severe mental illness and study of the impact of its use on the health status of caregivers
15939916|NCT03342235|Procedure|Photorefractive Keratectomy (PRK)|Subjects randomized to refractive surgery will be referred to one of six study surgical centers (surgical centers are listed in Appendix B) to have photorefractive keratectomy (PRK) in the affected eye within 60 days after randomization.
15939917|NCT03342235|Other|Patching 2 hours per day|Patching prescribed 2 hours per day with continued refractive correction (with spectacles and/or contact lenses) as able.
15939918|NCT03342235|Device|Excimer Laser System|Excimer Laser System for use in photorefractive keratectomy.
15939919|NCT03342222|Device|Interference Screws|tibial fixation for ACL reconstruction
15939948|NCT03341988|Drug|Ombitasvir-Paritaprevir-Ritonavir Tab 12.5-75-50 milligram|To asses curability of( Ombitasvir ,Paritaprevir,Ritonavir) in ch HCV infected patients in those with CKD vs ESRD 2- Also assess duration of sustained viral response,treatment, relapse or failure of therapy in CKD vs ESRD
15939949|NCT03341975|Behavioral|SexHealth|To enhance and test our ED SexHealth intervention that provides risk reduction counseling and point-of-care services as well as connections to sustainable, non-episodic sources of care.
15940378|NCT03338543|Device|PENS|percutaneous electrical nerve stimulation
15939920|NCT03342209|Device|Fisher&Paykel AIRVO™ 2 High Flow Nasal Cannula Therapy|"A high flow nasal cannula will be implemented to the CO-poisoned patients. In the meantime, intravenous access and cardiac monitorization will have been establishing. When the high flow nasal cannula becomes ready, the first venous blood sample will be taken and the treatment will be started without any delay. The gas flow rate will be started at the rate of 30 liters per minute and will be increased to the max flow rate which patient can tolerate and FiO2 of 1.0. If the first COHb level is lesser than 10%, the patient will be excluded and will receive standard emergency care.
~The blood sample will be drawn from existing IV access every 10 minutes until the COHb levels become %50 or lesser of the initial level.
~Once the COHb level becomes 50% of initial measurement, following blood samples will be taken in every 30 minutes."
15939921|NCT03342196|Drug|Melphalan|"Alkylating agent which is a derivative of mechlorethamine that inhibits DNA and RNA synthesis via formation of carbonium ions; cross-links strands of DNA; acts on both resting and rapidly dividing tumor cells.
~Melphalan may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash."
15939922|NCT03342196|Drug|Thiotepa|"Thiotepa is an alkylating agent which produces cross-linking of DNA strands leading to inhibition of DNA, RNA, and protein synthesis; thiotepa is cell-cycle independent.
~Thiotepa may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. It may cause damage to the GI tract causing mouth sores, nausea, vomiting, and diarrhea. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash."
15939923|NCT03342196|Drug|Fludarabine|"Fludarabine is an antineoplastic fluorinated nucleoside analog and inhibits DNA synthesis through inhibition of polymoerase alpha after incorporation into DNA.
~Fludarabine may cause a lowering of the white blood cell or platelet counts, leading to an increased risk of infection and frequent bruising or bleeding. Other side effects may include loss of appetite, liver abnormalities, hair loss, swelling, fatigue, sleepiness, skin rash, and lower limb weakness."
15939924|NCT03342196|Drug|Keratinocyte Growth Factor (KGF)|"Chemoprotective Agent.Recombinant keratinocyte growth factor (KGF) produced in E. coli. KGF binds to the KGF receptor resulting in proliferation, differentiation and migration of epithelial cells in multiple tissues, including (but not limited to) the tongue, buccal mucosa, esophagus, and salivary gland.
~Palifermin may cause rash, itching, redness, or discoloration of the skin. It may cause edema, an increase in pancreatic enzymes. It may cause arthralgias. It may cause tongue discoloration or tongue edema."
15939925|NCT03342183|Other|Intervention Arm|RIPC stimulus will be applied prior to the first intervention visit, using a previously validated (for cardiac protection in HD patients) standard dose (four cycles of cuff inflation to the lower limb of the patient and inflating at 200mmHg for five minutes, with five minutes' deflation).
15939926|NCT03342183|Other|Control Arm|Sham procedure in which the blood pressure cuff will be applied to the lower limb and inflated to 40mmHg for five minutes and deflated for five minutes with the cycle repeated a total of four times prior to dialysis. To be administered on a monthly basis from the baseline visit to the year 1 visit.
15939927|NCT03342170|Genetic|G20210A prothrombin gene mutation and Factor 5 Leiden mutation|blood sample
15939928|NCT03342157|Drug|senna/docusate|Stimulant laxative
15939929|NCT03342131|Other|Circulating wnt 2 and wnt 4 concentration|"Blood (150 each group) is obtained into ethylenediaminetetraacetic acid（EDTA） tubes from all subjects via antecubital venepuncture to explore circulating wnt 2 and wnt 4 concentration by ELISA. Continuous wnt2 and wnt4 concentration are measured in all patients with STEMI at 0 , 7days and 12 months after admission. Other patients with acute syndrome system are measured Wnt 2 and wnt4 only once within 24h after admission.
~Wnt2 and wnt4 concentration in Control group will be measured only once with 24h after admission."
15939930|NCT03342118|Drug|Phloroglucin(Flospan®)|The experimental group was taken with Phloroglucin(Flospan®) before endoscopy.
15939931|NCT03342118|Drug|Normal saline|The control group was treated with normal saline before endoscopy
15939932|NCT03342105|Procedure|Cettum|The treatment will be applied in 8 sessions, 2 times per week for 4 weeks. Moxibustion will be provided at 11 standard acupuncture points: EX-HN3, and both EX-HN8, LI20, LI4, GB2, ST36. A specifically designed device, Cettum (20X28X18mm) manufactured by K-medical Co.(Korea), will be used to treat patients in this group. The expected total time of each treatment session will be 15 min.
15939933|NCT03342105|Procedure|Acupuncture|The treatment will be applied in 8 sessions, 2 times per week for 4 weeks. Acupuncture will be provided at same points in the Cettum group. Sterile stainless steel disposable acupuncture needles (0.25X30mm, DongBang Acupuncture Inc, Korea) will be used to treat patients in this group. The needles will be kept in place for 15 min.
15939934|NCT03342092|Other|Questionnaire|Questionnaires distributed to the families 15 days before child's medical consultation + anthropometric measures and data collected from the personal interview with school nurse
15939935|NCT03342079|Drug|Local Anesthetics,Topical|topical anesthetic
15939936|NCT03342079|Drug|Nitrous Oxide|inhaled nitrous oxide
15939937|NCT03342079|Drug|Placebos|placebo topical anesthetic
15939938|NCT03342066|Diagnostic Test|reproducability of caries risk assessment|reproducability of caries risk assessment CAMBRA verses cariogram
15939939|NCT03342053|Drug|RO7234292 (RG6042)|Intrathecal injection
15939940|NCT03342040|Procedure|Laparoscopic ventral hernia repair with TAP block|Transverse abdominis plane block is given under ultrasound guidance during laparoscopic ventral hernia surgery
15939941|NCT03342040|Procedure|Laparoscopic ventral hernia repair without TAP block|No block administered during Laparoscopic ventral hernia surgery
15939942|NCT03342027|Drug|Bupropion|medication for smoking cessation
15939943|NCT03342027|Behavioral|Positively smoke free|an 8 session, tailored behavioral intervention for treating tobacco dependence
15939944|NCT03342027|Other|Brief advice to quit smoking|Standardized brief advice to quit smoking (standard of care)
15939945|NCT03342014|Device|Ultrasound|3DPD and UAD acquisitions (10 min)
15939946|NCT03342014|Biological|Blood sample collection|A blood sampling (20 mL) is collected for biomarker analysis (PAPP-A and PlGF) and biological collection.
15939947|NCT03342001|Drug|Calcitonin|calcitonin nasal spray
15940032|NCT03341325|Other|animal-assisted activity|a live animal (small dog and/or rabbit)
15939952|NCT03341949|Biological|Recurring blood sample|An additional tube will be collected for the assay of CD146s as part of the research
15939953|NCT03341936|Drug|Nivolumab|Nivolumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells
15939954|NCT03341936|Drug|Lirilumab|Lirilumab is a type of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells
15939955|NCT03341923|Device|Delefilcon A multifocal contact lenses|Silicone hydrogel multifocal contact lenses for daily disposable wear
15939956|NCT03341923|Device|Etafilcon A multifocal contact lenses|Hydrogel multifocal contact lenses for daily disposable wear
15939957|NCT03341910|Drug|DFD-03 Lotion, 0.1%|DFD-03 Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute.
15939958|NCT03341910|Drug|Tazorac Cream, 0.1%|Tazorac Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight.
15939959|NCT03341910|Drug|DFD-03 Vehicle Lotion 0%|Vehicle Lotion will be applied to the face (avoiding areas around the eyes and mouth) twice daily, approximately 12 hours apart, and washed off after 1 minute.
15939960|NCT03341910|Drug|Tazorac Vehicle Cream 0%|Vehicle Cream will be applied to the face (avoiding areas around the eyes and mouth) once daily in the evening and left on overnight.
15939961|NCT03341897|Procedure|endovasculer embolization of varicocele|"Step 1: Vascular Access
~Access can be achieved via the internal jugular or femoral veins. Step 2: Left Renal Vein Injection Step 3: Left Spermatic Vein Catheterization Step 4: Spermatic Vein Occlusion Step 5: Right Spermatic Venography POSTPROCEDURE CARE
~The patient is kept in bed for 1 hour postprocedure. The patient is advised to take anti-inflammatory agents as needed and to avoid any activity involving the Valsalva maneuver, such as lifting, vigorous, or hitting type sports for 3 full days beginning the day after the proce¬dure. Most patients report a minor dull ache in the back or groin lasting < 2 to 5 days. Fewer than 5% of patients will develop more severe pain lasting up to 14 days, requiring oral analgesics and anti-inflammatory agents and avoidance of vigorous exercise."
15939962|NCT03341884|Drug|Ipatasertib|A single oral dose of 100 mg ipatasertib will be administered.
15939963|NCT03341858|Other|no intervention-strictly observational|
15939964|NCT03341845|Drug|Axitinib|axitinib in combination with avelumab
15939965|NCT03341845|Drug|Avelumab|axitinib in combination with avelumab
15939966|NCT03341832|Drug|NVP-1203|oral dose for 7 days
15939967|NCT03341832|Drug|NVP-1203-R|oral dose for 7 days
15939968|NCT03341832|Drug|NVP-1203 placebo|oral dose for 7 days
15939969|NCT03341832|Drug|NVP-1203-R placebo|oral dose for 7 days
15939970|NCT03341819|Procedure|Total knee arthroplasty|A surgical procedure in which parts of the knee joint are replaced with artificial parts (prostheses)
15939971|NCT03341819|Procedure|Urinary Catheterization|Urinary catheterization is a latex, polyurethane, or silicone tube known as a urinary catheter is inserted into a patient's bladder via the urethra. Catheterization allows the patient's urine to drain freely from the bladder for collection.
15939972|NCT03341806|Drug|Avelumab|Avelumab will be administered intravenously every 2 weeks at a dose of 10 mg/kg for 2 cycles
15939973|NCT03341806|Combination Product|MRI-guided LITT therapy|(Part B) prior to receiving Avelumab 10 mg/kg every 2 weeks + LITT
15939974|NCT03341793|Diagnostic Test|Muscle biopsy and blood test|Characterize the changes in muscle secretion induced by bariatric surgery and determine their role in improving the insulin sensitivity of skeletal muscle and insulin secretion by B cell responsible for the remission of diabetes mellitus.
15939975|NCT03341780|Procedure|amblyopia therapy|Any of the following amblyopia training activities may be employed during patching: board games, card games, coloring in O's, comic books, craft projects, crossword puzzles, dot-to-dot patterns, drawing, hammering nails, jacks, jigsaw puzzles, lego and other blocks, marbles, mazes, peg-board activities, perceptual materials, pickup sticks, reading, sewing, shooting games, stringing beads, throwing or hitting games, tracing, and video or computer games.
15939976|NCT03341767|Drug|Clofazimine|50 or 100 mg micronized Clofazimine suspended in an oil-wax base in a gelatin capsule
15939977|NCT03341767|Drug|Placebo|Oil-wax in gelatin capsule
15939978|NCT03341754|Biological|D/ChAd63-CA|Priming Component (DNA) = NMRC-M3V-D-PfCA (D-CA) Vaccine Boosting Component = ChAd63-PfCA
15939979|NCT03341754|Biological|D/ChAd63-CAT|Priming Component (DNA) = NMRC-M3V-D-PfCAT (D-CAT) Boosting Component = ChAd63-PfCAT
15939980|NCT03341754|Other|Infectivity Control (IC) Group|Subjects will be exposed to bites of 5 Anopheles stephensi mosquitoes carrying infectious Pf sporozoites within a controlled clinical environment.
15939981|NCT03341741|Drug|Tobramycin Powder|TOBI®Podhaler 2 x 112 mg daily for 2 x 28 days (on/off);
15939982|NCT03341741|Drug|Colistin|Colistin solution 2 x daily 1 Mega continuously
15939983|NCT03341728|Behavioral|Optical flow perturbations|Continuous mediolateral (i.e., side-to-side) 20-minute perturbations of optical flow that elicit the visual perception of lateral imbalance via virtual reality during treadmill walking.
15939984|NCT03341728|Behavioral|Normal walking|Usual treadmill walking without optical flow perturbations
15939985|NCT03341715|Drug|Mavoglurant (AFQ056)|2-100mg tablets of Mavoglurant will be administered on the morning of 1 of the 2 experimental days by an RN or the physician investigator.
15939986|NCT03341715|Other|Placebo|Two matching tablets of placebo will be administered on the morning of 1 of the 2 experimental days by an RN or the physician investigator.
15939987|NCT03341702|Other|penintetiary's incident reports collection|collection of clinical and penitentiary 's data
15939988|NCT03341689|Drug|High Dose Psilocybin|0.143 mg/kg psilocybin capsule
15939989|NCT03341689|Drug|Low Dose Psilocybin|0.0143 mg/kg psilocybin capsule
15939990|NCT03341689|Drug|Placebo|microcrystalline cellulose capsule
15939991|NCT03341676|Drug|Dexamethasone|Dexamethasone 3.3 mg/mL solution for injection
15939992|NCT03341676|Drug|Placebo|Sodium Chloride 0.9% w/v solution for injection
15939993|NCT03341663|Combination Product|Coronary angiography,Canadian Cardiovascular Society angina pectoris classification for the severity of angina and electronic Von Frey instrument for testing the degree of acupoint sensitization|All the interventions were tested for only once
15940033|NCT03341325|Other|control activity|a stuffed toy animal
15940034|NCT03341312|Biological|LY900014|Administered SC
15939994|NCT03341650|Behavioral|High Pasta|Participants received a personalised diet program considering their food preferences and eating behaviour, based on the Italian guidelines for a healthy and Mediterranean diet and were encouraged to maintain their habitual consumption of pasta (at least 5 times/week). To encourage participants to prepare healthy meals by using high-quality ingredients, participants were provided with a recipe book and dietary guidelines and recommendations.
15939995|NCT03341650|Behavioral|Low Pasta|Participants received a personalised diet program considering their food preferences and eating behaviour, based on the Italian guidelines for a healthy and Mediterranean diet and were encouraged to maintain their habitual consumption of pasta (no more than 3 times/week). To encourage participants to prepare healthy meals by using high-quality ingredients, participants were provided with a recipe book and dietary guidelines and recommendations.
15939996|NCT03341637|Biological|Tetravalent Dengue Vaccine (TDV)|TDV subcutaneous injection
15939997|NCT03341637|Biological|Placebo|Normal Saline (0.9% NaCl) subcutaneous injection
15939998|NCT03341624|Procedure|cataract surgery cataract extraction and intraocular implantation|
15939999|NCT03341611|Behavioral|Neuro-imaging during behavioral decision-making task|All participants will make simple decisions while in a scanner.
15940000|NCT03341598|Procedure|CAF|Periodontal surgical technique to treat gingival recessions.
15940001|NCT03341598|Procedure|R|Restorative procedure to treat tooth structure loss.
15940002|NCT03341598|Procedure|MC|Xenogenous graft placed in the surgical site.
15940003|NCT03341585|Other|expiration lente prolongée|l'Expiration Lente Prolongée (ELPr) is a passive technique to enhance the expiration used in infants, obtained by a slow and increasing manual thoraco-abdominal pression applied at the end of a spontaneous expiration till the residual volume. The aim is to obtain a bigger expired volume compared to a normal expiration and drain the mucus out of the airways (Postiaux 2003). This technique has been invented by Guy Postiaux and is used in the Chest Physiotherapy (CPT).
15940004|NCT03341572|Other|5,10 and 15cmH2O positive end expiratory pressure|every patients undergo 5,10 and 15cmH2O positive end expiratory pressure,and observe the central venous pressure of the mentioned points
15940005|NCT03341559|Device|Spatial Frequency Domain Imaging (SFDI)|Observational study to measure perfusion in lower extremities for prediction of both healing and formation of diabetic foot ulcers using Reflect RS
15940006|NCT03341546|Other|A single measurement of the patient's abdominal depth|A single measurement of the patient's anterior-posterior abdominal depth
15940007|NCT03341533|Procedure|Ice packs plus usual post-op analgesia|A 9 inch by 12 inch zip lock bag filled with ice chips, placed inside a cotton pillow case, placed directly on the abdomen. Ice chips will be replaced as they thaw. Monitoring of surgical sites, skin integrity, and comfort with ice pack in place by nursing per current procedural guidelines.
15940008|NCT03341533|Other|Usual post-op analgesia|Standard post-operative analgesia orders will be followed.
15940009|NCT03341520|Drug|Obinutuzumab Injection [Gazyva]|7x 1000mg flat dose
15940010|NCT03341520|Radiation|Low dose radiation Therapy (LDRT)|2 x 2 Gy
15940011|NCT03341507|Device|classical laryngoscopy|the laryngoscopy with the McIntosh laryngoscope performed prior the use of rigid tube and the Cormack-Lehane glottis visualisation noted.
15940012|NCT03341507|Device|rigid tube for laryngoscopy|the view of glottis achieved with the rigid tub for laryngoscopy and tracheal intubation with an elastic gum bougie performed
15940013|NCT03341494|Drug|Thalidomide|Gefitinib 250mg Thalidomide 200 MG
15940014|NCT03341481|Other|Femaltiker|Patient had taken twice a day the product
15940015|NCT03341481|Other|Placebo|Patient had taken twice a day the placebo
15940016|NCT03341468|Device|Urethral catheter immobilization|"Subjects assigned to the control group will undergo radical prostatectomy with placement and securing of the urethral catheter per the standard of care. The catheter will be secured to the leg using cloth tape. Subjects will also be given an elastic leg strap that they may use following discharge, as is routine. Subjects will attend routine follow up appointments with their surgeon for removal of the urethral catheter and void trial.
~Subjects will be asked to fill out a symptom-based questionnaire prior to leaving the office. This will conclude their participation in the study."
15940017|NCT03341455|Behavioral|Capacity building to support families affected by IPV & substance misuse|Training targeted groups (mothers, fathers, preschool teachers, community officers managing preschools) separately with the aim to identify and support high-risk families early enough to arrest the cycle of violence that results in children themselves becoming victims and perpetrators of such violence.
15940018|NCT03341442|Procedure|No hip precautions|No hip precautions practiced after THA surgery
15940019|NCT03341429|Drug|Liraglutide Pen Injector [Saxenda]|Daily injection of GLP-1 agonist (liraglutide 3.0 mg) for obese patients presenting poor weight loss (<20%) after bariatric surgery and suboptimal GLP-1 levels.
15940020|NCT03341429|Drug|Placebo|Daily subcutaneous injection
15940021|NCT03341416|Device|deep brain stimulation on stimulation - active|bilateral deep brain stimulation reaching the dentate nucleus turned ON - phase active
15940022|NCT03341416|Device|deep brain stimulation off stimulation - sham|bilateral deep brain stimulation reaching the dentate nucleus turned OFF - phase sham
15940023|NCT03341403|Dietary Supplement|Probiotical®|"Probiotical is composed of: Lactobacillus, Bifidobacterium et Streptococcus thermophilus, 18 billion of bacteria per pill."
15940024|NCT03341403|Other|Placebo|pills containing placebo
15940025|NCT03341390|Drug|Aspirin|1 x 325 mg tablet of aspirin administered once daily
15940026|NCT03341390|Drug|BMS-986177|200 mg of BMS-986177 administered twice daily
15940027|NCT03341390|Drug|Placebo|200 mg of Placebo administered twice daily
15940028|NCT03341364|Behavioral|ACT-based group therapy|6 group therapy sessions over 6 weeks (one session à 2 hours weekly), plus one follow-up session 6 weeks after last session. The sessions are lead by a psychologist and a social worker. Each session containing discussions, experimental exercises and home-work assignment.
15940029|NCT03341364|Behavioral|ACT individual treatment|3-12 individual therapy sessions over 3-16 weeks, plus one follow-up session 6 weeks after last session, lead by a clinical psychologist. Each session containing discussion, experimental exercises and home-work assignment.
15940030|NCT03341351|Other|Instructional video|Instructional video using the modified beef tongue model
15940031|NCT03341351|Other|Instructional workshop|Instructional workshop using the modified beef tongue model.
15940039|NCT03341273|Drug|Azithromycin|Azithromycin is an azalide antibiotic and is derived from erythromycin used to treat many different types of infections caused by bacteria, such as respiratory infections.
15940040|NCT03341273|Other|Placebo|Placebo will be a matching capsule the same size, weight, and color as the capsules containing Azithromycin tablets.
15940041|NCT03341273|Device|VIDAS B.R.A.H.M.S Procalcitonin Test (PCT)|The VIDAS B.R.A.H.M.S PCT is an automated test for use on the VIDAS instruments for the determination of human procalcitonin in human serum or plasma using the Enzyme-Linked Fluorescent Assay (ELFA) technique.
15940042|NCT03341260|Drug|Diclofenac Potassium 50mg Tab.|A 50 mg tablet of the medication to be taken one hour before initiation of endodontic treatment.
15940043|NCT03341260|Drug|Placebo|A placebo will be taken one hour before initiation of endodontic treatment.
15940044|NCT03341234|Drug|Bupivacaine|30 ml %0,25 bupivacaine
15940045|NCT03341234|Drug|Saline|2 ml saline subcutaneously
15940046|NCT03341234|Device|Ultrasound|Ultrasound guided block
15940047|NCT03341208|Diagnostic Test|Cardiac Magnetic Resonance Imaging|Cardiac MRI will be performed before and after subject has undergone catheter directed therapy
15940048|NCT03341195|Behavioral|SMS messages and automated calls|The intervention consists of SMS and automated calls based messages
15940049|NCT03341182|Procedure|Fluoroscopically Guided Lumbar Transforaminal Epidural Injections|Lay the subject down on the stomach and hold the pillow on the stomach. The skin of the injection area is sterilized by aseptic method and covered with aseptic pouch. After confirming the level of he vertebrae around the C-arm and aligning the anteroposterior view of the endplate of the vertebral body, rotate the C-arm 20~30 degrees diagonally in the direction to be performed. After confirming the best Scotty dog view, confirm the final target point at 6 o'clock directly below the pedicle. At this position, the skin point is marked on the skin. And then both groups proceed in parallel with the beam direction of the transducer with the tunnel view technique until the needle reaches the back of the vertebral body at the level of the spinal nerve roots. At this time group A uses a mirror and group B dose not. The final reach of the target point (ideal depth) is confirmed through the anterior and posterior views and lateral views.
15940050|NCT03341182|Procedure|conventional manner|A portable mirror is located at the side of surgical table and used in this procedure.
15940051|NCT03341169|Drug|N(2)-L-Alanine L-Glutamine dipeptide|:Intravenous infusion of N (2) -L-alanyl-L-glutamine(mixed with normal saline, ratio 1:1) at the dose of 0.25g/kg(body weight) for 8 hours before induction of anesthesia(rate=2.5*weight/8 ml/h) and administration another 0.25g/kg(body weight) of N (2) -L-alanyl-L-glutamine(mixed with 8.5% amino acid solution, ratio 1:5) into the central vein for 10 hours after induction of anesthesia(rate=0.75*weight ml/h)
15940052|NCT03341169|Drug|placebo (0.9% NaCl (normal saline))|Intravenous infusion of 0.9% NaCl for 8 hours before induction of anesthesia(rate=2.5*weight/8 ml/h) and administration 0.9% NaCl into the central vein for 10 hours after induction of anesthesia(rate=0.75*weight ml/h)
15940053|NCT03341156|Drug|Kcentra|Kcentra will be administered in 2 divided doses; Pre-bypass (5-10 units/kg based on body weight and preoperative INR and post-protamine based of the pre-bypass dose and the preoperative INR; daily maximum dose not to exceed 5000 IU (50 IU/kg)
15940054|NCT03341156|Drug|Frozen Plasma Product, Human|If the patient is randomized to receive standard transfusion they will receive 2 U of fresh frozen plasma intravenously before cardiopulmonary bypass and then up to 4-8 U of plasma added to the cardiopulmonary bypass reservoir during rewarming.
15940055|NCT03341143|Drug|Fecal Microbiota Transplant with Pembrolizumab|"FMT is a procedure in which fecal matter or stool is collected from a tested donor, mixed with a saline or other solution, strained and infused into the colon by doing a colonoscopy. The FMT consists of introducing normal bacterial flora contained in stool collected from a donor into your small intestine. In this case, the donor is patient with advanced melanoma who has been treated with a PD-1 inhibitor (nivolumab or pembrolizumab) and has been rendered disease-free as a result. The FMT will be performed on Cycle 1 Day 1.
~Pembrolizumab, 200mg, through an IV over 30 minutes on Cycle 1 Day 1 (same day as the FMT, and then again on Day 1 of each 21-day cycle for an additional 3 cycles (Cycles 2 - 4)."
15940056|NCT03341130|Device|Mandibular Repositioning Splint|The Morning Repositioner is a hands-free bite deprogrammer designed to help return the patient's jaw back to its pre-treatment centric position.
15940057|NCT03341130|Device|Mandibular Advancement Oral Appliance|Mandibular Advancement Oral Appliances are dental splints used to keep the jaw in an advanced position, opening the upper airway during sleep.
15940058|NCT03341117|Drug|Acetylsalicylic acid|Acetylsalicylic acid 300 mg per capsule
15940059|NCT03341117|Drug|Calcined magnesia|Calcined magnesia 300 mg per capsule
15940060|NCT03341104|Drug|Bupivacaine liposome|Replace bupivacaine with bupivacaine liposome
15940061|NCT03341091|Other|Tai-chi group|The Tai-chi group received a 16-week 10-step simplified Tai-chi training programme in which additional measures were implemented to enhance participants' engagement.
15940062|NCT03341078|Drug|Ibudilast|Ibudilast capsules will be orally ingested twice daily for 6 weeks.
15940063|NCT03341078|Drug|Placebo Oral Tablet|Placebo capsules will be orally ingested twice daily for 6 weeks.
15940064|NCT03341065|Device|exoskeleton type robot|
15940065|NCT03341065|Device|end-effector type robot|
15940066|NCT03341052|Other|Normal Diet|The normal diet will consist of the participants' normal eating habits, and will be tracked by a food log. The participants will be on their normal diet during week 1 and week 3.
15940067|NCT03341052|Other|High Fat Diet|The high fat diet will consist of 2700 kcal, 100g total fat (33%), 300mg cholesterol, 350g carbohydrates (52%), and 100g protein (15%). The participants will be on this diet during week 2.
15940068|NCT03341052|Other|Low Fat Diet|The low fat diet will consist of 1200 kcal, 26g fat (20%), 78mg cholesterol, 150g carbohydrates (50%), and 100g protein (30%). The participants will be on this diet during week 4.
15940069|NCT03341026|Other|Metronom CGM device|Patient receives three Metronom CGM devices on day 1. On day 1, 4, 7 and 14, a hypo- or hyperglycaemic experiment will start according to allocation by randomizer.
15940070|NCT03341026|Other|Metronom CGM device|Patient receives three Metronom CGM devices on day 1. On day 1, 7, 10 and 14, a hypo- or hyperglycaemic experiment will start according to allocation by randomizer.
15940071|NCT03341013|Drug|MEDI0382 Formulation 2|Sequence 1 Period 1 and Sequence 2 Period 2.
15940072|NCT03341013|Drug|MEDI0382 Formulation 3|Sequence 1 Period 2 and Sequence 2 Period 1
15940073|NCT03341000|Device|DISCSS Device|This pilot feasibility study will explore and help determine optimal settings and configuration of the DISCSS™ System with patients that have completed a percutaneous trial with a commercially available SCS trial system.
15940074|NCT03340987|Procedure|vestibular incision subperiosteal tunnel access|vertical vestibular incision will be made down to the periosteum followed by creating a tunnel without reflecting the interdental papilla. Then a free gingival graft will be optained from the palate and de-epithelialized extraorally. The connective tissue graft will then be applied through the tunnel and the gingival margin will be sutured and the sutures will be fixed to the tooth surface by flowable composite. Then the vestibular incision will be sutured.
15940075|NCT03340987|Procedure|Coronally advanced flap|Two horizontal incisions will be made mesial and distal to the recession area followed by two oblique incisions extended to the alveolar mucosa and a full-split thickness flap will be elevated. De-epithelialization will be done to receive the connective tissue graft obtained from the palate by de-epithelializing a free gingival graft. Then the flap will be advanced coronally aand sutured without tension
15940076|NCT03340974|Drug|Avasopasem (GC4419)|90 mg Avasopasem (GC4419) per day daily (60 min IV infusion, prior to SBRT), concurrent with daily fractions of SBRT to assigned dose level, administered Monday - Friday over one week.
15940077|NCT03340974|Drug|Placebo|Placebo daily (60 min IV infusion, prior to SBRT), concurrent with daily fractions of SBRT to assigned dose level, administered Monday - Friday over one week.
15940078|NCT03340974|Radiation|Stereotactic Radiation Therapy (SBRT)|Dose-finding will be done using the sequentially adaptive phase I-II Late onset Efficacy-Toxicity (LO-ET) trade-off-based design.
15940079|NCT03340961|Drug|DFD-29 Extended Release Capsules (40 mg)|Oral Treatment
15940080|NCT03340961|Drug|DFD-29 Extended Release Capsules (20 mg)|Oral Treatment
15940081|NCT03340961|Drug|Oraycea® (doxycycline) Capsules|Oral Treatment
15940082|NCT03340961|Drug|Placebo Capsules|Oral Treatment
15940083|NCT03340948|Behavioral|Mindfulness Based Stress Reduction (MBSR)|An 8-week course in mindfulness meditation, yoga training and weekly group support in the form of weekly 2,5 hour meetings at the hospital.
15940084|NCT03340935|Other|Fasting mimicking diet|Fasting Mimicking Diet (or FMD) consists in a 5-day plant-based, low-calorie (600 Kcal on day 1, followed by 300 KCal/day on days 2 to 5), low-protein, low carbohydrate diet
15940085|NCT03340922|Device|Automatic annotation of LAT (WF-method)|Automatic annotation of LAT during PVC activation mapping. Acquisition of points will be automatically performed using the Wavefront (WF) annotation tool integrated into CARTO navigation system.
15940086|NCT03340922|Device|Manual annotation of LAT (M-method)|Conventional, manual annotation of LAT during PVC activation mapping. Acquisition of points will be performed using the CARTO navigation system by an expert electrophysiologist.
15940087|NCT03340909|Drug|Prednisolone|Prednisolone tablets initiated at 40 mg for three days, after which it will be phased out within 6 weeks after start
15940088|NCT03340909|Other|Placebo|Placebo tablets initiated at 40 mg for three days, after which it will be phased out within 6 weeks after start
15940089|NCT03340896|Drug|Docetaxel|Docetaxel 75 mg / m² administered on day 1 of each cycle every 3 weeks as an intravenous (IV) infusion of one hour followed by cisplatin 75 mg / m² administered on day 1 hour infusion followed by 5-FU, 750 mg / m² / day administered in continuous infusion from D1 to D5 (or 120 hours)
15940090|NCT03340896|Drug|Cisplatin|Cisplatin: 75 mg/m² for experimental arm and 100mg/m² for comparator arm administered on day 1 of each cycle every 3 weeks as an intravenous (IV) infusion.
15940091|NCT03340896|Drug|Fluorouracil|5-FU, 750 mg / m² / day administered in continuous infusion from D1 to D5 (or 120 hours)
15940092|NCT03340896|Radiation|radiotherapy|Radiotherapy : 70Gy (2Gy/day) for 7 weeks.
15940093|NCT03340883|Biological|BION-1301|a solution for intravenous (IV) administration, diluted and administered Q2W
15940094|NCT03340870|Drug|Sonazoid™|Single Dose of Sonazoid™ lipid-stabilised aqueous suspension of perfluorobutane (PFB) gas microbubbles.
15940095|NCT03340857|Other|Intelligent electric bicycle (VELIS) sessions|Oncology patients will participate in intelligent electric bicycle (VELIS) sessions twice a week for 6 weeks after their release from a rehabilitation and recuperative care facility
15940098|NCT03340831|Device|Continuous Glucose Monitoring (CGM)|Use of CGM to compare incidence of diabetes events compared to use of a blood glucose meter (BGM)
15940099|NCT03340818|Other|Bone Marrow Concentrate|Bone marrow concentrate is bone marrow harvested from the iliac crest and minimally processed in a centrifuge. It is then injected into the suspected painful disc (s) using fluoroscopic guidance
15940100|NCT03340818|Other|Placebo|Injection of normal saline dorsal to the transverse process after sham bone marrow aspiration
15940101|NCT03340805|Drug|Lactated Ringer|"LR is a sterile, nonpyrogenic balanced solution used for fluid and electrolyte replenishment via intravenous or intraosseous administration. Each 100 mL of LR contains 600 mg sodium chloride (NaCl), 310 mg of sodium lactate (C3H5NaO3), 30 mg of potassium chloride (KCl), and 20 mg of calcium chloride (CaCl2 · 2H20) with an approximate potential of hydrogen (pH) of 6.5 (6.0 to 7.5)."
15940102|NCT03340805|Drug|Normal saline|"Normal saline solution is an unbalanced crystalloid solution containing 154 mEq/L of sodium and 154 milliequivalent (mEq/L) of chloride."
15940103|NCT03340792|Device|Ambulation training utilizing an exoskeleton robot|Participants undergo 40 hours of ambulation training utilizing an exosksleton robot within 3 months.
15940179|NCT03340116|Diagnostic Test|Measurement of RBC volume, plasma volume, and total blood volume using Daxor BVA-100|Measurement of RBC volume, plasma volume, and total blood volume using Daxor BVA-100
15940181|NCT03340103|Drug|Placebo|Placebo solution with unique excipients (Demineralised water, potassium sorbate, xanthan gum, citric acid)
15940104|NCT03340779|Drug|Norepinephrine|After obtention of a mean arterial pressure (MAP) of 65 mmHg with infusion of norepinephrine, patients with cardiogenic shock receive for 3 hours either increasing doses of norepinephrine (with a maximal MAP of 85 mmHg) or dobutamine. There is a wash-out phase of 30 minutes (decrease of norepinephrine dose or weaning of dobutamine). The third phase of the study is the administration of the comparator treatment during 3 hours. After the 6.5 hours of the study, the hemodynamic management is up to the physician.
15940105|NCT03340766|Drug|Blinatumomab|"Up to 2 cycles of Blinatumomab may be given, where cycle 1 lasts 8 weeks, and cycle 2 lasts 28 days. The treatment is given as a continuous intravenous infusion. The dosing given is dependent on the cohort, and is as follows:
~Cohort Ia: 9 microgram/day for 7 days followed by 28 microgram/day for the remainder of each cycle.
~Cohort IIa: 9 microgram/day for 7 days followed by 28 microgram/day for 7 days followed by 56 microgram/day for the remainder of each cycle.
~Cohort IIIa: 9 microgram/day for 7 days followed by 28 microgram/day for 7 days followed by 112 microgram/day for the remainder of each cycle.
~The Maximum Tolerated Dose identified through this cohort design will then be tested in the expansion cohort."
15940106|NCT03340766|Drug|Pembrolizumab|"One cycle of Pembrolizumab is a 200 milligrams intravenous injection lasting 30 minutes. One cycle will be given every 3 weeks until disease progression, or for a maximum of 35 cycles.
~Treatment start is dependent on the cohort:
~Cohort Ia: Study day 15 (where blinatumomab treatment started on study day 1) Cohort IIa, IIIa: Study day 19 (where blinatumomab treatment stated on study day 1)"
15940107|NCT03340753|Drug|KBP-5074 mineralocorticoid receptor antagonist|KBP-5074 (0.5 mg or 1.0 mg) in either capsule or tablet formulation, single dose, in a 2-period crossover design with a 2-week washout/follow-up period
15940108|NCT03340740|Drug|Cetirizine Hydrochloride 1 MG/ML|Cetirizine oral suspension
15940109|NCT03340740|Drug|Placebo - Concentrate|Similar-appearing liquid to cetirizine oral suspension
15940110|NCT03340727|Drug|Caffeine Citrate|The study intervention is caffeine citrate given once daily at 10 mg/kg/day. It is given orally, before hospital discharge and 28 days after discharge.
15940111|NCT03340727|Drug|Placebo|The study intervention is placebo given once daily at a volume equivalent to 10 mg/kg of caffeine citrate. It is given orally, before hospital discharge and 28 days after discharge.
15940112|NCT03340714|Device|Monitoring Device|Wear ADAMM
15940113|NCT03340701|Drug|vaginal progesterone suppository|200mg vaginal suppository micronized progesterone
15940114|NCT03340688|Procedure|Cervical cerclage|Cervical cerclage indicated by short cervix ≤15mm
15940115|NCT03340675|Drug|Ifetroban|Weight based, once daily oral ifetroban
15940116|NCT03340675|Drug|Placebo|Matching oral placebo
15940117|NCT03340662|Drug|CC-122|CC-122
15940118|NCT03340662|Drug|Itraconazole|CYP3A Inhibitor
15940119|NCT03340662|Drug|Fluvoxamine|CYP1A2 Inhibitor
15940120|NCT03340662|Drug|Rifampin|CYP3A Inducer
15940121|NCT03340649|Other|taking peripheral blood|taking peripheral blood of no more than 3ml
15940122|NCT03340623|Device|Venous coupler|A coupler can be used to perform a venous anastomosis. It is a double ring with pins on only one of its 2 faces. The technique consists in clamping the two veins, estimating the intima-to-intimal diameter of the vessels, choosing the coupler of the appropriate size, sliding the vein in the ring and evers the edges of the vessel to fix them on the pins, redo the same thing for the other vein and finally bring the two vessels together in order to clip them together.
15940123|NCT03340610|Drug|Alflibercept|Intravitreal Injection
15940124|NCT03340597|Drug|F901318|F901318 tablet
15940125|NCT03340584|Other|the Nine Castle Net Format Taping|The intervention group received traditional rehabilitation and Taping throughout all rehabilitation period.The taping including a Nine Castle Net Format of taping in both side of surgery knee.We will exchange the new taping for every two days， for a week.Traditional rehabilitation included occupational therapy and physical therapy, patients took part in the traditional rehabilitation training for 30 minutes each day, for a week.
15940126|NCT03340584|Other|traditional rehabilitation|traditional rehabilitation included occupational therapy and physical therapy, patients took part in the traditional rehabilitation training for 30 minutes each day, for a week.
15940127|NCT03340558|Biological|Atezolizumab|Atezolizumab is a fully humanized, engineered monoclonal antibody of IgG1 isotype against the protein programmed cell death-ligand 1.
15940128|NCT03340558|Drug|Cobimetinib|MEK inhibitor
15940129|NCT03340545|Other|Custom Magnetic Resonance Elastography Device|Magnetic Resonance Elastography is an imaging method to measure mechanical properties of tissues.
15940130|NCT03340532|Other|THE INFORMATION + APPEARANCE VIDEO|THE INFORMATION + APPEARANCE VIDEO which will include the full information video, along with an additional embedded video segment emphasizing negative appearance consequences of UV exposure.
15940131|NCT03340532|Other|Information SunSmart video|The INFORMATION SunSmart video providing basic information about UV risks, including secondary skin cancer and the benefits of SP, as well as specific SP recommendations and steps to integrate SP as part of routine self-care for the healthy cancer survivor
15940132|NCT03340532|Other|Sleep hygiene video|Contain information on better sleep hygiene
15940133|NCT03340519|Device|MR Imaging|Novel MR imaging will be performed to provide bowel anatomic and functional data
15940136|NCT03340493|Drug|Tenecteplase|Tenecteplase 0.25mg/kg and 0.4mg/kg are being used
15940137|NCT03340480|Drug|NVP-1402|Oral
15940138|NCT03340467|Device|CGM patch|Patient receives four CGM patches.
15940139|NCT03340454|Other|Test-and-treat EHR-CHW intervention|a health systems-level intervention using electronic health record (EHR)-based tools to facilitate H. pylori test-and-treat strategies
15940140|NCT03340454|Other|Usual care of EHR-only intervention|a community-engaged culturally and linguistically adapted CHW-led patient navigation program we are currently pilot testing for feasibility and acceptability.
15940141|NCT03340441|Device|Prizma|sensor unit with mobile application installed on smartphone
15940180|NCT03340103|Dietary Supplement|LUTEIN ofta 0,5 gocce|LUTEIN ofta 0,5 gocce, containing a solution of 5% Lutein and 2,5% Zeaxanthin with excipients (Corn starch, glucose, potassium sorbate, xanthan gum, citric acid)
15940319|NCT03338959|Biological|Pembrolizumab|Given IV
15940142|NCT03340428|Behavioral|Transition Community Adherence Club (TCAC)|A behavioral intervention targeting stigma and care challenges through care delivery, social capital through a group setting, improved job prospects through referrals and training, and substance use through referrals. Participants assigned to this group will meet at least every month in a group of 5-15 members for approximately 2 hours. During the meeting there will be facilitated group discussion, an interactive curriculum including life skills, economic skills, HIV and health, and disclosure and stigma. Individual health screening and distribution of prepackaged medications conclude the session. Individual referrals for specific services (e.g. mental health or substance use management) will be available.
15940143|NCT03340415|Other|Accelerated Rehabilitation plan|early weight bearing after surgery
15940144|NCT03340402|Radiation|Accelerated Partial Breast Irradiation|Proton radiation
15940145|NCT03340402|Device|AlignRT|AlignRTTM uses infrared imaging to capture the 3D data of the patient's position to ensure accuracy of treatment delivery
15940146|NCT03340389|Procedure|a ray-tracing aberrometry|The Dysfunctional Lens Index is obtained by a ray-tracing aberrometry
15940147|NCT03340376|Drug|Atezolizumab|atezolizumab
15940148|NCT03340376|Drug|Doxorubicin|Doxorubicin
15940149|NCT03340363|Behavioral|environmental change|"Offer kid-friendly, low-cost recipes in a prominent, high-traffic location.
~Offer healthy default ingredients (bundled ingredients promoted with recipes).
~Promote recipe ingredients with prominently displayed signage and images.
~Promote recipes in multiple locations throughout the store."
15940150|NCT03340363|Behavioral|messaging|Short, behavioral messages sent to participants via text message or email each week to promote the in-store environmental changes
15940151|NCT03340350|Drug|Minocycline|Minocycline capsule
15940152|NCT03340337|Device|Neo-Russian|"Subjects will receive Neo-Russian electrical stimulation with three reps (5 sec work x 120 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured. They will be asked how uncomfortable the stimulation was, using Visual Analogue Scale (VAS).
~One week later, subjects will receive a fatigue protocol that consists in 21 reps (5 sec work x 5 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured for each contraction."
15940153|NCT03340337|Device|Aussie|"Subjects will receive Aussie electrical stimulation with three reps (5 sec work x 120 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured. They will be asked how uncomfortable the stimulation was, using Visual Analogue Scale (VAS).
~One week later, subjects will receive a fatigue protocol that consists in 21 reps (5 sec work x 5 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured for each contraction."
15940154|NCT03340337|Device|RBS|"Subjects will receive RBS electrical stimulation with three reps (5 sec work x 120 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured. They will be asked how uncomfortable the stimulation was, using Visual Analogue Scale (VAS).
~One week later, subjects will receive a fatigue protocol that consists in 21 reps (5 sec work x 5 sec rest), and the Maximal Electrical Induced Contraction (MEIC) will be measured for each contraction."
15940155|NCT03340324|Biological|V-Endo|V-Endo is a tableted immunotherapeutic derived from hydrolyzed, heat-inactivated, pooled blood from women with endometriosis
15940156|NCT03340311|Device|iHealth Wireless Smart Gluco- Monitoring System (BG5)|Over the course of 8 weeks, participants collected serum glucose logs (SGL) for 4 weeks using usual care followed by SGL's log for 4 weeks using Bluetooth-enabled glucometers and the iGluco application.
15940157|NCT03340298|Dietary Supplement|fiber|the intervention of different sources of dietary fibers
15940158|NCT03340285|Dietary Supplement|AkP06|first 2 weeks: Placebo + Diet then 4 weeks AkP06 two tablet/day before meals + Diet
15940159|NCT03340285|Dietary Supplement|Placebo|first 2 weeks: Placebo + Diet then 4 weeks placebo two tablet/day before meals + Diet
15940160|NCT03340259|Procedure|Exposure(s) of interest: enterostomy|Newborn infants with congenital malformations of the gastrointestinal tract, necrotizing enterocolitis, and spontaneous intestinal perforation commonly require surgery and enterostomy. In these infants samples of the enterostomy effluent will be collected and DNA extracted for microbiota identification.
15940161|NCT03340246|Procedure|Delayed sclerotherapy|See arm descriptions
15940162|NCT03340246|Procedure|Immediate phlebectomy|See arm description
15940163|NCT03340233|Diagnostic Test|MRI (cardiac) off-label use gadolinium contrast (IND exempt)|Clinical MRI
15940164|NCT03340233|Diagnostic Test|MRI (cardiac)|MRI without contrast
15940165|NCT03340220|Drug|XPF-008|Capsule filled with XEN1101
15940166|NCT03340220|Drug|Microcrystalline Cellulose|Placebo capsule
15940167|NCT03340207|Device|Pneumaglide|The device is designed to facilitate intubation and reduce the time to intubation. It works with traditional glidescope to make the process of intubation easier. In this study patients scheduled for surgery and intubation, will be randomized to two groups. The intervention group will be intubated with the help of the pneumaglide. Yet, the other group will receive standard intubation. We aim to evaluate the efficacy of the Pneumaglide to improve the ease of intubation in unskilled clinicians and skilled clinicians during difficult and routine intubations
15940168|NCT03340194|Radiation|Radiography|Radiography of the hand and feet (face incident) the day of the inclusion
15940169|NCT03340194|Procedure|Veinous punction|Blood sample to analysis VEGF, endothelin 1, endostatin and P/GF, (ELISA method)
15940170|NCT03340181|Other|RIPC|4 cycles of 5-min ischemia(using a blood pressure cuff inflated to 40mmHg over the patient's basic blood pressure) and 5-min repercussion are done on an upper limb before skin incision.
15940171|NCT03340168|Other|Bisphenol-S|Oral and dermal exposure in volunteers
15940172|NCT03340155|Other|Photo(chemo)therapy|Treatment with photo(chemo)therapy, including UVB, UVA, PUVA and photopheresis
15940173|NCT03340142|Device|VIVO™|Diagnose the area of a PVC or VT onset
15940174|NCT03340129|Drug|Ipilimumab|Ipilimumab 3mg per kg every 3 weeks for 4 doses
15940175|NCT03340129|Drug|Nivolumab|Nivolumab 1mg/kg every 3 weeks for 4 doses, then 480mg every 4 weeks.
15940176|NCT03340129|Radiation|Stereotactic Radiotherapy|The first dose of immunotherapy Must be given prior to the start of radiotherapy. One fraction at between 16 to 22 Gy or 24 to 30 Gy hypofractionated for larger lesions.
15940177|NCT03340129|Other|Salvage therapy|Any form of salvage therapy (surgery or radiotherapy) for intracranial disease progression, further disease control at any site, symptom control or treatment of cerebral haemorrhage or cerebral radionecrosis.
15940182|NCT03340090|Device|Medical Device Hemopatch-PEG-coated collagen patch|Two pieces of PEG-coated collagen patch Hemopatch will be applied in one patient. One piece to improve hemostasis in the bed of LIMA harvesting and second piece of Hemopatch will be placed beneath the sternum.
15940183|NCT03340077|Other|Medicines Optimisation Review toolkit|The Review tool consist of two items. 'My Clinic companion' and 'MOR consultation form'. 'My clinic companion' (see appendix 1) is a patient-orientated questionnaire that promotes self-review of medications and adherence and will facilitate the pharmacist consultation. The 'MOR consultation form' (see appendix 2), is designed to aid a structured patient consultation using available information from local databases, GP medication histories as well as that obtained directly from the patient. The form also identifies key care providers involved in the patient case, including prior consent to contact with information if required.
15940184|NCT03340077|Other|Standard of Care|Pharmacist review of ART medications
15940185|NCT03340064|Drug|Levetiracetam|levetiracetam dry syrup 50% for oral administration and levetiracetam solution for infusion (100 mg/mL)
15940186|NCT03340051|Behavioral|Episodic Future Thinking (EFT)|EFT participants will generate positive future events they are looking forward to and that could happen at different future time points (e.g., in 2 weeks, 1 month, 6 months, 1 year). Participants will be instructed to use and think about their episodic cues as they make decisions.
15940187|NCT03340051|Behavioral|Episodic Recent Thinking (ERT)|ERT participants will list positive recent events (events that have already happened) that they enjoyed that occurred at different past time points (e.g., 12 hours ago, 24 hours ago, a week ago). Participants will be instructed to use and think about their episodic cues as they make decisions.
15940188|NCT03340038|Other|Non-ICU Specialty ward|
15940189|NCT03340025|Device|PICO Single Use Negative Pressure Wound Therapy System|Class II negative pressure wound therapy powered suction pump
15940190|NCT03340025|Device|xeroform gauze|traditional surgical dressing of xeroform gauze and padding
15940191|NCT03340012|Device|GTR + radiation-sterilize allogenic bone graft|Guided tissue regeneration of intrabony defects with collagen membrane (Bio-Gide® Perio, Geistlich Biomaterials) and radiation-sterilized allogenic bone graft from the Central Tissue Bank in Warsaw
15940192|NCT03340012|Device|GTR + xenogenic graft|Guided tissue regeneration of intrabony defects with collagen membrane (Bio-Gide® Perio, Geistlich Biomaterials) and xenogenic graft (Bio-Oss®, Geistlich Biomaterials)
15940193|NCT03339999|Drug|AGN-242428|AGN-242428 administered as an oral capsule(s) once daily.
15940194|NCT03339999|Drug|Placebo|Placebo administered as an oral capsule(s) once daily.
15940195|NCT03339986|Behavioral|Reduction or Replacement|
15940196|NCT03339973|Biological|allo-APZ2-PAOD|Suspension of ABCB5-positive mesenchymal stem cells in pre-filled syringe
15940197|NCT03339973|Drug|Placebo|Solution for injection in pre-filled syringe
15940198|NCT03339960|Other|Ergonomic measurement|Ergonomic measurement of the surgeon and assistant
15940199|NCT03339947|Other|Questionnaire|
15940200|NCT03339921|Drug|Botulinum toxin injections for chronic compartment syndrome|Botulinum toxin will be injected in the upper and lower portion of the affected area with a syringe
15940201|NCT03339921|Procedure|surgical fasciotomy for chronic compartment syndrome|linear incisions will be made into the affected compartment releasing the underlying fascial layer, reducing the pressure of the compartment
15940202|NCT03339908|Device|Thalamotomy by gamma Knife radiosurgery|The surgical procedure consists of a very partial radiation of the brain with stereotaxic precision
15940203|NCT03339895|Other|pvı-guided|pvı- guided total amount of crystalloid volume of fluid infused during colorectal surgery pvı-guided(according to pvi value) fluid infused during whole procedure 2 ml/kg/h infusion during surgery If PVI value <%13 and if MAP>65mmHg continue with 2 ml/kg/h cristalloid infusion If PVI value <%13 and if MAP>65mmHg 5 mcg efedrin intravenous bolus till MAP>65 mmHg If PVI value >%13 and MAP>65 mmHg infuse 250 ml Gelofusine bolus up to PVI value lowers to %13 every 5 minute If PVI value >%13 and MAP <65 mmHg infuse 250 ml Gelofusine bolus and 5 mcg efedrin intravenous up to PVI value lowers to %13
15940204|NCT03339895|Other|traditional-guided|traditional-guided total amount of crystalloid volume of fluid infused during colorectal surgery traditional-guided fluid infused during whole procedure 4-8 ml/kg/h infusion during surgery If MAP <65 mmHg or <30%of basal value, infuse 250 ml Gelofusine bolus and 5 mcg efedrin If MAP>65 mmHg no intervention
15940205|NCT03339882|Drug|Remifemin|Remifemin 0.2g po bid*12 weeks at the beginning of the LHRH-a treatment
15940206|NCT03339869|Other|Blood sample|The blood samples will be taken from the patient's bed and then sent to the clinical pharmacology laboratory of Prof. Blin (DRC, Bat F, Timone Hospital).
15940207|NCT03339856|Device|Selective retina therapy|"The selective retina therapy (SRT) is a laser treatment to the retina using the R:GEN device (Lutronic, Goyang-si, South Korea).
~Laser energy began at 80 µJ and was increased in 5-10 µJ intervals until the optimal energy delivery was confirmed by the RFD system. Following confirmation, the optimal laser energy was applied to fluorescein leakages. If the energy was indeed optimal at leakage points, laser shots were administered around the leakages. If the energy was not optimal at the leakage points, laser energy was again increased in 5-10 µJ increments until optimal energy delivery."
15940208|NCT03339843|Drug|Abemaciclib|Subjects will receive 200 mg of abemaciclib orally, two times a day, during cycles of 28 days each. An early FDG-PET/CT will be performed at cycle 1 day 14 to search for any new lesions.
15940209|NCT03339817|Diagnostic Test|Polysomnography|During polysomnographia and functional pulmonary testing, signs of diaphragmatic dysfunction responsible for respiratory disorders will be searched.
15940210|NCT03339804|Other|Chemotherapy|In chemoteraphy session, doxorubicin (60 mg/m2) and cyclophosphamide (600mg/m2) were administred in 45 min
15940211|NCT03339791|Procedure|Sleeve Gastrectomy|Laparoscopic Sleeve Gastrectomy. Technique: complete mobilization of the greater curvature and gastric fundus up to the angle of Hiss; stapling beginning at 3 to 4 cm away from the pylorus; bougie size 32 French; oversuture of the staple line; hiatoplasty in selected cases; routine drainage of the abdominal cavity
15940212|NCT03339791|Procedure|Gastric Bypass|Laparoscopic Gastric Bypass. Technique: Pouch size 30 to 40 ml, biliopancreatic limb 70 to 100 cm, alimentary limb 100 to 120 cm, antecolic, routine closure of the mesenterial defects, routine drainage of the abdominal cavity
15940320|NCT03338959|Radiation|Radiation Therapy|Undergo radiation therapy
15940321|NCT03338946|Device|CIED interrogation|CareLink Express interrogation
15940213|NCT03339765|Behavioral|Strong Together serious game|The Strong Together serious game program is an interactive, immersive education program in which participants quickly learn the behaviors of self-advocacy and the potential consequences of self-advocating or not. Participants will receive weekly game sessions to play at home for three months.
15940214|NCT03339752|Drug|Rosuvastatin|10 mg tablet
15940215|NCT03339752|Drug|ACT-541468|25 mg hard capsule
15940216|NCT03339739|Other|Isometric mandibular exercises|daily video guided three-minutes routine in 21 days (days of OC consumption) of soft clenching over three millimeters silicone bars bilaterally on molars
15940217|NCT03339739|Other|Isotonic mandibular exercises|daily video guided three-minutes routine in 21 days (days of OC consumption) of isotonic dynamic contraction over calibrated cloth pegs on central incisors
15940218|NCT03339739|Behavioral|Counseling group|subjects included in this group get an education brochure about the disorder and receive no further interventions
15940219|NCT03339726|Drug|New Formulation Phenylephrine HCl|2 doses of one tablet 12 hours apart
15940220|NCT03339726|Drug|Marketed Phenylephrine HCl|4 doses of one capsule 4 hours apart
15940221|NCT03339726|Drug|Placebo|4 doses of placebo capsule and tablet taken 4 hours apart
15940222|NCT03339713|Biological|Ad26.RSV.preF|Ad26.RSV.preF will be administered as intramuscular injection at a dose of 1*10^11 vp.
15940223|NCT03339713|Biological|Fluarix|Fluarix will be administered as intramuscular injection.
15940224|NCT03339713|Biological|Placebo|Placebo will be administered as intramuscular injection of sterile 0.9 percent (%) saline for injection.
15940225|NCT03339700|Drug|Gemcitabine|4800mg/m2, intravenous (IV), divided 4 days, 1200mg/m2/day, during days -5 to -2
15940226|NCT03339700|Drug|Busulfan|12mg/kg, Oral, divided in 4 days, 3mg/kg/day Oral, during days -7 to -4.
15940227|NCT03339700|Drug|Cyclophosphamide|80mg/kg, intravenous (IV), divided in 2 days, 40mg/kg/day IV, during days -3 and -2.
15940228|NCT03339700|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Bone Marrow HSC (allogeneic HSCT) transfusion, day 0
15940229|NCT03339687|Behavioral|Experimental Mindset Induction|"This induction of a psychological state was extensively studied in cognitive science. Gollwitzer & Keller (2016, p.3): The deliberative mindset is evoked by asking participants to (a) name an unresolved, important personal problem that is causing rumination but for which they have not made a decision yet and (b) reflect on whether to take action or not. Further, to enhance the depth of reflection, participants are requested to list positive and negative, short- and long-term consequences of both deciding to act and not to act; indicating the probability of the occurrence of each of these consequences is required.
~The implemental mindset is evoked by asking participants to think of a personal project for which they have already made the decision to act but did not initiate any action yet. Subsequently, participants are asked to list the steps necessary for successful goal attainment and to plan out in detail when, where, and how they intend to act on each of these steps."
15940230|NCT03339674|Behavioral|Psychoeducational Group Intervention on Alcohol Drinking Related to Stress|Manualized and standardized psychotherapeutic group intervention with three sessions of 60 min duration each which are to be delivered in a one-week period.
15940231|NCT03339674|Behavioral|Cognitive Training|Manualized and standardized psychotherapeutic group intervention with three sessions of 60 min duration each which are to be delivered in a one-week period.
15940232|NCT03339661|Drug|Group 1_No proph treatment|After the curative treatment of CMV infection until a negative CMV ADNemia, secondary prophylaxis with valganciclovir will be established based on the results of γδ T cells immunomonitoring. In this group, expansion of γδ T cell at the end curative treatment was detected, so secondary prophylaxis will not be started.
15940233|NCT03339661|Drug|Group 2A_Proph treatment and γδ T cell expansion|After the curative treatment of CMV infection until a negative CMV ADNemia, secondary prophylaxis with valganciclovir will be established based on the results of γδ T cells immunomonitoring. In this group, γδ T cell expansion will not be detected, so secondary prophylaxis will be initiated in continue during 3 months maximum. The occurrence of γδ T cells expansion during or at the end of secondary prophylaxis will define the group 2A.
15940234|NCT03339661|Drug|Group 2B_Proph treatment and no γδ T cell expansion|After the curative treatment of CMV infection until a negative CMV ADNemia, secondary prophylaxis with valganciclovir will be established based on the results of γδ T cells immunomonitoring. In this group, γδ T cell expansion will not be detected, so secondary prophylaxis will be initiated in continue during 3 months maximum. Patients who still not had γδ T cells expansion during or at the end of secondary prophylaxis will compose the group 2B.
15940235|NCT03339648|Behavioral|Professional Development Enhancement|Professional development for SROs enhanced by content concerning trauma-informed care, cultural competency, restorative justice, and social-emotional learning.
15940236|NCT03339635|Drug|Androgel (Testosterone gel)|Patients will be randomized to treatment with transdermal testosterone gel (Androgel) once daily during 20 weeks, followed by 20 weeks of active Androgel treatment in all participants.
15940237|NCT03339635|Drug|Placebo gel|Patients will be randomized to treatment with transdermal placebo gel once daily during 20 weeks, followed by 20 weeks of active Androgel treatment in all participants.
15940238|NCT03339622|Combination Product|PPP001|1 pellet smoked three times a day with titanium pipe (280 mg dried cannabis pellet - 9% THC / 2% CBD per pellet)
15940239|NCT03339622|Combination Product|placebo|1 pellet smoked three times a day with titanium pipe (280 mg dried cannabis pellet - 0% THC / 0.6% CBD per pellet)
15940240|NCT03339609|Diagnostic Test|Uroflow|Isolated uroflow measurement
15940241|NCT03339609|Diagnostic Test|Uroflow/EMG|Uroflow measurement with superficial EMG testing of the pelvic floor
15940242|NCT03339609|Diagnostic Test|US|Ultrasound of post void residual urine
15940243|NCT03339596|Drug|Erythropoietin|40.000 IU/ml Erythropoietin (Epoetin alpha; Eprex) diluted with 100 ml saline (0.9% NaCl) is administered 4 times as intravenous infusions over 15 minutes.
15940244|NCT03339596|Drug|Saline|1 ml NaCl is administered 4 times as intravenous infusions over 15 minutes
15940322|NCT03338933|Behavioral|magnetic resonance imaging (MRI)|All subjects will undergo a baseline MRI and subjects in both alcohol groups (alcohol use disorder and combined alcohol and nicotine use disorder) will undergo a followup MRI 3 months after baseline.
15940323|NCT03338920|Drug|sumatriptan nasal powder|nasal powder administered via nosepiece
15940324|NCT03338920|Drug|Placebo|lactose monohydrate powder administered via nosepiece
15940245|NCT03339583|Behavioral|Brief behavioral therapy|"program included a question-and-answer part; a didactic presentation of sleep regulation mechanisms; the review of causes of onset and chronification of illness; an examination of patient's sleep log; explanation of sleep restriction method and prescription of individual regimen of sleep; explanation of stimulus control method; sleep hygiene education; discussion of relaxation techniques. Participants were supplied with 32 minute audio recording Relaxation and refreshment session for insomnia created for this study by Dr. A.Tabidze with verbal relaxing instructions with quiet musical composition behind it. Participants were instructed to listen to this recording in headphones each day for 2-week BBT-I period after laying into bed and turning the light off."
15940246|NCT03339583|Drug|Zopiclone|zopiclone intake in a dose of 7,5 mg 30 minutes before bedtime for two weeks
15940247|NCT03339557|Device|NexGen|Comparing two conventional designs and one novel design
15940248|NCT03339557|Device|Persona|Comparing two conventional designs and one novel design
15940249|NCT03339557|Device|PFC|Comparing two conventional designs and one novel design
15940250|NCT03339544|Drug|Celebrex premedication|celebrex (celecoxib) 200mg is a non-steroidal anti-infalmmatory drug with selective COX-2 inhibition.
15940251|NCT03339544|Drug|Placebo|placebo is given as a tablet before initiation of endodontic treatment
15940252|NCT03339531|Radiation|2D radiotherapy|
15940253|NCT03339518|Behavioral|BRIM3 educational intervention|Breast Cancer risk education and counseling
15940254|NCT03339518|Behavioral|Wait List|Booklet at the end of study
15940255|NCT03339505|Dietary Supplement|Salovum|Dietary supplement with high concentration of anti-secretory factor
15940256|NCT03339505|Dietary Supplement|Placebo|Placebo for Salovum
15940257|NCT03339492|Device|RCStim Model 1114|Active device emits PEMF signal; placebo/control device does not emit PEMF signal
15940258|NCT03339479|Diagnostic Test|dielectric property test|Test the dielectric property of resected lung nodules/mass through a touching probe after the lung tissue with nodules/mass has been resected and cut open, which usually takes only 1-5 minutes.
15940259|NCT03339479|Diagnostic Test|frozen pathological examination|And after the dielectric property test, the lung tissue will be sent for frozen pathological examination.
15940260|NCT03339479|Diagnostic Test|final pathological examination|All of the lung nodules/mass will be diagnosed by final pathological examination and recognized as the final diagnosis after surgery.
15940261|NCT03339466|Device|Inspiratory muscle therapy|6 weeks of inspiratory muscle therapy
15940262|NCT03339453|Drug|Nasal Glucagon|Administered nasally
15940263|NCT03339453|Drug|Intramuscular Glucagon|Administered IM
15940264|NCT03339440|Behavioral|Hearts & Parks|The Hearts & Parks intervention will be looking to evaluate how different types of physical activity and nutrition education and support (in addition to normal clinical care) through attendance and participation in the Duke Healthy Lifestyles/Bull City Fit clinic/community program, affect children's health. The investigators will be looking at changes in BMI, physical activity, nutrition and overall health.
15940265|NCT03339427|Other|vitamin D|different doses of vitamin D supplementation
15940266|NCT03339427|Other|control|control group
15940267|NCT03339414|Other|collect blood|collect blood at different time point
15940268|NCT03339401|Other|Standard of Care|Local institutional standard of care (SoC) (i.e., investigator-assigned therapy) for the treatment of adenovirus infection in high-risk pediatric allogeneic hematopoietic cell transplant (HCT) recipients.
15940269|NCT03339401|Drug|Brincidofovir|Brincidofovir (BCV) for the treatment of adenovirus infection in high-risk pediatric allogeneic hematopoietic cell transplant (HCT) recipients.
15940270|NCT03339375|Device|esophageal Doppler|Goal directed fluid therapy using dynamic parameters from esophageal Doppler
15940271|NCT03339362|Procedure|Active Procedure|"If they pass the diagnostic injection with a 50% or more in pain reduction, they are randomised to receive either the active procedure or sham procedure.
~Active: 4 X-ray guided intra-articular lumbar facet-joint injections via a spinal needle at 2 bilateral lumbar levels using 0.5ml bupivacaine + 20mg methylprednisolone per joint"
15940272|NCT03339362|Procedure|Sham procedure|"If they pass the diagnostic injection with a 50% or more in pain reduction, they are randomised to receive either the active procedure or sham procedure.
~Sham: 4 X-ray guided peri-articular injections via a spinal needle at 2 bilateral lumbar levels using 0.5ml of 0.9% sodium chloride per joint."
15940273|NCT03339349|Drug|Enoxaparin|Enrolled patients will receive real-time monitoring of peak and trough steady state anti-Xa levels. Out-of-range patients will receive real time dose adjustment of Enoxaparin using a clinical protocol developed with our inpatient pharmacists.
15940274|NCT03339336|Drug|BIIB074|Administered as specified in the treatment arm.
15940275|NCT03339336|Drug|Placebo|Administered as specified in the treatment arm.
15940276|NCT03339323|Other|Exercise|TKA patients do the exercise intervention
15940277|NCT03339310|Device|Optimizer Smart System with 2-leads|The Optimizer Smart System with 2-leads delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Implanted subjects receive five non-contiguous one-hour periods of CCM signals per day.
15940278|NCT03339297|Drug|Defibrotide|6.25 mg/kg via 2-hour IV infusion every 6 hours
15940279|NCT03339297|Drug|Standard of Care|Administered according to local institutional guidelines, physician preference, and patient need.
15940280|NCT03339284|Drug|Dexamethasone sodium phosphate|Dexamethasone injection
15940281|NCT03339284|Drug|Ropivacaine Hydrocloride|Ropivacaine injection
15940282|NCT03339284|Drug|Sodium Chloride 9mg/mL|Sodium Chloride injection
15940283|NCT03339271|Behavioral|Technology-Enhanced Support|The study nurse will meet with the caregiver daily until patient is discharged from the hospital. The caregiver will take home an iPad upon discharge, and will have an initial video chat with the study nurse within 24-48 hours of hospital discharge and weekly for 8 weeks after that.
15940284|NCT03339271|Behavioral|Usual Care Support|The patient's doctor and nurses with input from the Palliative Care service will help the caregiver make a plan for discharge of the patient, and for taking care of the patient upon discharge. Someone from the study team will call the caregiver once a month for the duration of the study after the patient discharges from the hospital.
15940325|NCT03338907|Drug|Oxycarbon (5% CO2+ 95% O2)|Oxycarbon will be administered by mechanical ventilation
15940326|NCT03338894|Behavioral|Yoga|1 Hour yoga class
15940285|NCT03339258|Drug|Doxazosin Mesylate, Extended Release|Doxazosin is FDA-approved for the treatment of hypertension and urinary outflow problems associated with benign prostatic hyperplasia. The immediate-release formulation is approved for use from 1mg up to 16mg. Based on drug company information and Micromedex, the SFVA pharmacy on-line reference resource for drug information, the only contraindication to use of doxazosin is hypersensitivity to doxazosin, its contents, or other quinazolines (e.g. prazosin, terazosin).
15940286|NCT03339258|Drug|Placebo|Placebo, or inactive pill.
15940287|NCT03339245|Other|Fructose Solution (75 Grams)|Fructose given in divided doses at breakfast and dinner.
15940288|NCT03339245|Other|Glucose Solution (75 grams)|Glucose given in divided doses at breakfast and dinner.
15940289|NCT03339232|Dietary Supplement|BCAA Supplement|Each teaspoon contains 1788 mg of BCAA and participants will take 7 teaspoons (12.5 grams of BCAA) per day divided into three separate servings. Each teaspoon contains L-leucine, isoleucine and valine in a 2:1:1 ratio.
15940290|NCT03339232|Other|Physical Activity|Supervised low impact aerobic physical activity for one hour each week.
15940291|NCT03339219|Drug|Cabozantinib|Cabozantinib tablets
15940292|NCT03339206|Behavioral|Constituent message with FDA and quitline|Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect. This arm will also include an FDA logo, and information about the benefits of quitting smoking and the quitline. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order. Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication. Design of these messages was developed by our team.
15940293|NCT03339206|Behavioral|Constituent message without FDA and quitline|Messages about the chemical constituents of cigarette smoke will include text about chemicals in cigarette smoke and health effects of the chemicals, and an image of a person related to the health effect. This arm is identical to the arm above, except that it does not include FDA source or quit information. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order. Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication. Design of these messages was developed by our team.
15940294|NCT03339206|Behavioral|Littering message (Control)|Messages about littering cigarettes will include text designed to discourage people from littering their cigarette butts, and an image related to the message. Each condition has 5 messages that will be repeated 3 times in a counterbalanced order. Study investigators used text developed by investigators associated with our Center for Regulatory Research on Tobacco Communication. Design of these messages was developed by our team.
15940295|NCT03339193|Device|Left atrial appendage closure|Percutaneous insertion of a Watchman FLX left atrial appendage closure device under general anesthesia with transesophageal echo guidance.
15940296|NCT03339167|Dietary Supplement|Metabolic availability of lysine in millet|Four levels of lysine intakes will be provided by the reference protein drinks, 3 levels of lysine from millet and 1 level from millet with lentils.
15940297|NCT03339154|Other|Dietary Intakes|Four levels of methionine intakes will be provided by the reference protein drinks, 3 levels of methionine from chickpeas and 3 levels from chickpeas with rice.
15940301|NCT03339115|Device|Cardiovalve Transfemoral Mitral Valve|The Cardiovalve Transfemoral Mitral Valve System is intended for use symptomatic patients with severe mitral regurgitation who are at elevated risk for surgical mitral valve repair or replacement and who are anatomically eligible for transfemoral mitral valve replacement with transseptal access to the left atrium.
15940302|NCT03339076|Device|"M3 MINI CATHETER"|"Participants in the study are using either a foley catheter or Clean Intermittent Catheter devices to facilitate bladder drainage. The study is an alternative method of facilitating bladder drainage with the M3 Mini Catheter."
15940303|NCT03339050|Behavioral|Health for Hearts United|The intervention was framed around three conceptual components (awareness building, clinical learning, and efficacy development), and four types of programming (church-initiated, joint programming, standard programming (culturally tailored post cards and newsletters), and data collection health promotion (generic materials, clinical sessions with an Registered Dietitian). Key messages were identified for the intervention including eating better, moving around more, reducing stress, and taking charge of your health.
15940304|NCT03339037|Device|Hyperbaric oxygen therapy|60 HBOT sessions at 2 ATA 100% oxygen
15940305|NCT03339037|Device|Normobaric air SHAM|60 sessions at 1 ATA 21% oxygen (air)
15940306|NCT03339024|Drug|intranasal oxytocin spray|6 insufflations (24 IU of oxytocin total) given twice daily, day 1-3. 2 insufflations (8 IU of oxytocin total) as needed, max thrice daily, day 3-30 Day 30 - 12 months: No further oxytocin treatment, i.e. treatment-as-usual.
15940307|NCT03339024|Other|intranasal spray without oxytocin|6 insufflations (24 IU of placebo total) given twice daily, day 1-3. 2 insufflations (8 IU of placebo total) as needed, max thrice daily, day 3-30 Day 30 - 12 months: No further oxytocin treatment, i.e. treatment-as-usual.
15940308|NCT03339011|Behavioral|Motivational SMS text message|Motivational text messages delivered to the participants' mobile phones. The text messages contain motivational text and advice on physical activity.
15940309|NCT03338998|Drug|BAF312 solution|Solution for intravenous (IV) infusion - 4.5mg/4.5mL
15940310|NCT03338998|Drug|Matching Placebo for BAF312 solution|Solution for intravenous (IV) infusion - 0mg/4.5mL matching placebo
15940311|NCT03338998|Drug|BAF312 tablet|2 mg film-coated tablet
15940312|NCT03338998|Drug|Matching Placebo for BAF312 tablet|0 mg film-coated tablet matching placebo
15940313|NCT03338985|Genetic|Genetic analysis|Genetic analysis of the samples taken during the surgery (hysterectomy or curettage resection) using CGH array technique.
15940314|NCT03338972|Biological|Autologous Anti-BCMA-CAR-expressing CD4+/CD8+ T-lymphocytes FCARH143|Given IV
15940315|NCT03338972|Drug|Cyclophosphamide|Given IV
15940316|NCT03338972|Drug|Fludarabine|Given IV
15940317|NCT03338972|Other|Laboratory Biomarker Analysis|Correlative studies
15940318|NCT03338972|Procedure|Leukapheresis|Undergo leukapheresis
15940330|NCT03338868|Other|Physical activity level|assessed by the International Physical Activity Questionnaire-7
15940331|NCT03338868|Other|Musculoskeletal pain intensity|evaluated with Visual Analog Scale
15940332|NCT03338868|Other|Quality of life|assessed by the Nottingham Health Profile
15940333|NCT03338868|Other|Psychological Well-Being|assessed by the Hospital Anxiety and Depression Scale
15940334|NCT03338868|Diagnostic Test|Blood tests|Blood tests included serum glucose, triglyceride, high-density lipoprotein cholesterol (HDL-C), and uric acid levels. Blood samples were collected from the patients after one night of fasting.
15940335|NCT03338855|Drug|Dapagliflozin|"The study consist of 5 weeks treatment period 1, 6-8 weeks wash-out period and 5 weeks treatment period 2.
~The patient will be administered dapagliflozin 10 mg during Period 1 or Period 2."
15940336|NCT03338842|Device|Distractor and Lower limb VR|In the first phase (A), subjects will receive the Distraction VR treatment during 5, 6, or 7 one-hour-long sessions occurring twice weekly. After the A phase, the remaining sessions (B phase) will consist of Lower-Limb VR treatment. This number includes a mean of 6 (range 5-7) phase A sessions and mean of 11 (range 10-12) phase B sessions.
15940337|NCT03338829|Behavioral|Positive incentive|Compensation is paid for each glucose test completed
15940338|NCT03338829|Behavioral|Loss aversion|Fixed compensation is offered to patients and they can earn a range of compensation at the completion of pregnancy depending on overall glucose testing adherence
15940339|NCT03338816|Drug|Givosiran|Givosiran by SC
15940340|NCT03338816|Drug|Placebo|Matching placebo (normal saline [0.9% NaCl]) by SC
15940341|NCT03338803|Drug|Linagliptin|drug
15940342|NCT03338790|Biological|nivolumab|Specified dose on specified days
15940343|NCT03338790|Drug|docetaxel|Specified dose on specified days
15940344|NCT03338790|Drug|enzalutamide|Specified dose on specified days
15940345|NCT03338790|Drug|rucaparib|Specified dose on specified days
15940346|NCT03338790|Drug|prednisone|Specified dose on specified days
15940347|NCT03338777|Biological|Suicide plus immunogene therapy|"Intra and peritumoral infiltrates with multiple injections of 0.1 ml/cm2 or 0.2 ml/cm3 of lipoplexes bearing the HSVtk suicide gene (1: 1; 1 mg/ml, according to tumor size), co-administered with GCV (12.5 mg/ml). Patients start with a minimum of 0.5 ml and at the 3rd week, the maximum dose is scaled according to the tumor size up to 2 ml maximum.
~Treated simultaneously with a subcutaneous vaccine produced with:
~Formolized allogeneic tumor extracts and,
~Lipoplexes carrying hIL-2 and hGM-CSF genes (0.5 mg each)."
15940348|NCT03338764|Drug|SM-1|SM-1 3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam self-administered as needed to promote sleep
15940349|NCT03338764|Drug|Placebo|Identical in appearance to SM-1 and has the same excipients, but no active ingredients or delayed-release coating materials, self-administered as needed to promote sleep
15940350|NCT03338751|Diagnostic Test|cognitive testing with HAD (PockeTalker) First|tablet, loaded with REDCap will generate a random number that determines the order of test administration with the HAD first or second.
15940351|NCT03338751|Diagnostic Test|Cognitive testing without HAD First|tablet, loaded with REDCap will generate a random number that determines the order of test administration with the HAD first or second.
15940352|NCT03338738|Diagnostic Test|Stool culture ans swab|"Patients with ESBL enterobacteria, antibiotic pressure are patients with ESBL positive result diagnosed by stool culture and a rectal swab.
~The intervention correspond to addition of 4 stool samples (or 4 rectal swabs in the absence of stool emission) and a blood sample."
15940353|NCT03338725|Other|Clinical pharmacy model|Patients who are being monitored by a clinical pharmacy model
15940354|NCT03338699|Device|ShangRing|Topical anesthesia based, no-flip ShangRing circumcision.
15940355|NCT03338699|Device|Mogen clamp|Mogen clamp circumcision
15940356|NCT03338686|Procedure|Free Gingival Graft (FGG)|Free Gingival Graft (FGG) was performed on all study sites in this arm.
15940357|NCT03338686|Procedure|Connective Tissue Graft followed by Laser Gingivoplasty|Connective Tissue Graft followed by Laser Gingivoplasty one month later on all study sites in this arm.
15940358|NCT03338673|Device|tDCS|tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function
15940359|NCT03338673|Other|BrainHQ|BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
15940360|NCT03338660|Biological|Infusion of Platelets|Platelets will be stored using novel, FDA approved, technique. Subjects will receive infusion of platelets stored by novel technique, routine storage, and placebo (saline).
15940361|NCT03338660|Biological|Infusion of Platelets|Platelets will be stored using the routine platelet storage method. Subjects will receive infusion of platelets stored by routine storage method.
15940362|NCT03338660|Biological|Placebo|Subjects will receive infusion placebo (saline).
15940363|NCT03338647|Drug|DEB|Infusion of DEB or doxorubin/lipiodol through catheter in the hepatic artery
15940364|NCT03338647|Radiation|SBRT|High precision radiation therapy to the liver tumor(s)
15940365|NCT03338621|Drug|Pretomanid|200 mg tablets
15940366|NCT03338621|Drug|Bedaquiline|100 mg tablets
15940367|NCT03338621|Drug|Moxifloxacin|400 mg tablets
15940368|NCT03338621|Drug|Pyrazinamide|500 mg tablets
15940369|NCT03338621|Drug|HRZE|isoniazid 75 mg plus rifampicin 150 mg plus pyrazinamide 400 mg plus ethambutol 275 mg combination tablets
15940370|NCT03338621|Drug|HR|isoniazid 75 mg plus rifampicin 150 mg combination tablets
15940371|NCT03338608|Procedure|Anterior Cervical Decompression and Fusion|Patients will receive the anterior cervical decompression and fusion as part of their standard of care. They will be randomized to either receive the vertical or transverse platysma incision.
15940372|NCT03338608|Procedure|Vertical Platysma Incision|A vertical platysma Incision will be used for the anterior cervical decompression and fusion surgical procedure
15940373|NCT03338608|Procedure|Transverse Platysma Incision|A transverse platysma incision will be used for the anterior cervical decompression and fusion surgical procedure
15940374|NCT03338569|Drug|Vitamin C|Continuous infusion of vitamin C
15940375|NCT03338569|Drug|Placebo|Placebo designed to mimic intervention
15940376|NCT03338556|Drug|PrEP-001|
15940377|NCT03338556|Other|Placebo|
15940380|NCT03338530|Behavioral|Comprehensive School-Based Intervention|School staff administered the 5 components during the school year. Social Skills Groups were conducted 2-3x/wk. for a total of 60-90 min./wk.; each group contained 3-6 students with social impairments. The Individual Daily Note was administered across the school day to reinforce new skills and reduce problem symptoms. Students' performance on targets was linked to home rewards. Mind Reading computer instruction targeting emotion recognition skills was conducted 3x/wk. for a total of 60 min./wk. Therapeutic Activities were conducted 2x/wk. for a total of 40-60 min./wk.; these cooperative activities were designed to practice targeted skills. Parent Training was conducted 1x/month for 60-90 min./session in order to increase home-school communication and integrate the CSBI across settings.
15940381|NCT03338517|Other|Helium Neon Laser|
15940382|NCT03338504|Diagnostic Test|Invasive coronary angiography|Where patients are fit, coronary angiography will be performed via the femoral or radial artery with 6F arterial catheters. In patients with one or more stenoses in a major epicardial vessel, a coronary pressure guidewire (PressureWire™ Aeris™, St. Jude Medical, St. Paul, Minnesota) will be used to determine distal coronary pressure and the fractional flow reserve (FFR) calculated at maximal adenosine-induced (intravenous 140 μg/kg/min) hyperaemia. Optical coherence tomography (OCT) will be performed in all three coronary vessels using a Dragonfly® coronary imaging catheter (Abbott Diagnostics, Abbott Park, Illinois) with pullback at 20 mm/s to identify features consistent with vulnerable plaque or recent plaque rupture.(16) If there is evidence of inducible myocardial ischaemia due to coronary artery stenosis, revascularisation with percutaneous coronary intervention may be considered if in the patients best interests.
15940383|NCT03338504|Radiation|CT coronary angiography|CT coronary angiography will be performed using a 128 multidetector row CT. Patients with a heart rate exceeding 65 beats/min will receive oral beta-blockade 1 hour before computed tomography. Additional intravenous beta blockers will be given depending on heart rate at the time of imaging. All patients will receive sublingual glyceryl trinitrate (300 μg) immediately prior to dual cardiac and respiratory-gated computed tomography imaging of the coronary arteries. The investigators will quantify total plaque burden using CT calcium scoring. A bolus of 80-100 mL of contrast will be injected intravenously at 5 mL/s. An assessment of the functional consequences of coronary artery stenosis will be made using the computed tomography fractional flow reserve (CT-FFR) technique, using the HeartFlow platform.
15940384|NCT03338504|Diagnostic Test|Cardiac MRI|Cardiovascular magnetic resonance (CMR) will be performed using a 3T scanner. The MRI scan will consist of localisers, axial and coronal HASTE images, standard breath-held and ECG-gated cine sequences. Short-axis cine images will be obtained for the assessment of left ventricle function and volumes. Left ventricle volumes, mass and ejection fraction will be assessed using dedicated software and values indexed to body surface area. Breath-held, ECG-gated T2 mapping sequences of the myocardium will be performed in the short-axis as a marker of myocardial inflammation. T1-weighted imaging of the coronary arteries will be performed to look for evidence of recent intraplaque thrombus or haemorrhage. The late gadolinium enhancement and T2 mapping techniques will identify regions of new or old myocardial infarction as well as other patterns of injury. Where there are no contraindications, stress MRI will be performed using intravenous Regadenoson.
15940385|NCT03338491|Behavioral|Induction of Implemental Mindset|"This induction of a psychological state was extensively studied in basic cognitive science. Gollwitzer & Keller (2016, p.3): The implemental mindset is evoked by asking participants to think of a personal project for which they have already made the decision to act but did not initiate any action yet. Subsequently, participants are asked to list the steps necessary for successful goal attainment and to plan out in detail when, where, and how they intend to act on each of these steps."
15940386|NCT03338491|Behavioral|Induction of Deliberative Mindset|"This induction of a psychological state was extensively studied in basic cognitive science. Gollwitzer & Keller (2016, p.3): The deliberative mindset is evoked by asking participants to (a) name an unresolved, important personal problem that is causing rumination but for which they have not made a decision yet and (b) reflect on whether to take action or not. Further, to enhance the depth of reflection, participants are requested to list a number of positive and negative, short- and long-term consequences of both deciding to act and deciding not to act; indicating the probability of the occurrence of each of these consequences is required."
15940387|NCT03338478|Diagnostic Test|Wii Balance Board|Participants will stand on the Wii Balance Board with eyes open, eyes closed, one two feet, and then standing on one leg at each study visit.
15940388|NCT03338465|Device|Duolith SD1, STORZ Medical, Switzerland with F-SW applicator|The procedure will be performed with the patient in lateral positioning of the decubitus. The treatment area will be prepared with a coupling ultrasound gel to minimize the loss of shockwave energy at the interface between the tip of the applicator and the skin. The inline ultrasonic guide will be used to concentrate the shockwaves on the pain area in the trochanteric region. No local anesthesia will be applied.
15940389|NCT03338452|Behavioral|Low energy ketogenic diet|Low energy ketogenic diet lasting 12 weeks with a previous preparation period including detailed instructions during classes and individual counselling by a dietitian. Participants were provided with a list of suitable foods with very low carbohydrate content. Furthermore, the subjects shared cooking recipes and links to helpful webpages. They were free to follow a KD according to their personal preferences but limit their carbohydrate intake to 5-10 % of total energy from carbohydrates, but derive at least 70 % of total energy from fat.
15940390|NCT03338439|Device|CSII|This retrospective, observational trial will evaluate 104 diabetic patients with prior treatment with MDI initiating CSII therapy compared to 109 diabetic patients continuing MDI.
15940391|NCT03338426|Drug|Fimasartan 120mg|Fimasartan 120mg will be administrated once daily for 8 weeks treatment period
15940392|NCT03338426|Drug|Atorvastatin 40mg|Atorvastatin 40mg will be administrated once daily for 8 weeks treatment period
15940393|NCT03338426|Drug|Placebo for Fimasartan 120mg|Placebo for Fimasartan 120mg will be administrated once daily for 8 weeks treatment period
15940394|NCT03338426|Drug|Placebo for Atorvastatin 40mg|Placebo for Atorvastatin 40mg will be administrated once daily for 8 weeks treatment period
15940395|NCT03338413|Behavioral|Goal Management Training|9 GMT modules will be administered in 9X2 hour sessions (ten groups). Manualized intervention; metacognitive strategies for improving attention and problem solving.
15940438|NCT03337997|Procedure|Irreversible Electroporation|Open Irreversible Electroporation by ultrasound guidance for tumors under 3 cm in diameter. Goal is to obtain an Amp rise of 12 or more
15940578|NCT03337048|Device|SpeediCath|SpeediCath is a standard intermittent catheter that is on the market.
15940396|NCT03338413|Behavioral|Computerized Cognitive Training|9 modules will be administered in 9x1 hour session (ten groups). Computerized Cognitive Training using commercially available web-based platforms based on neuroplasticity, developed to target skills such as attention, memory, speed of processing and executive functioning. Homework assignment between sessions.
15940397|NCT03338400|Drug|Dexamethasone|Patients will be randomized to Dexamethasone arm will receive 8mg (2ml) of Dexamethasone at the time of induction.
15940398|NCT03338400|Drug|Normal saline|Patients randomized to normal saline will receive 2ml of Normal saline at the time of induction.
15940399|NCT03338387|Drug|Acipimox|Acipimox
15940400|NCT03338387|Drug|Placebo|Placebo Other Names: Placebo (for Olbetam)
15940401|NCT03338374|Device|Biventricular pacemaker|All subjects will receive a biventricular pacemaker at implantation. Programming will initially be to dual-chamber, dual-function rate-responsive pacing for 12 weeks; following reassessment, device will be reprogrammed to biventricular pacing for a further 12 weeks. Optional study extension: if incremental benefit is shown for biventricular pacing above dual chamber, the mechanism will be sought using echocardiographic evidence and the devices will be optimised according to this mechanism of action to see whether further benefit can be achieved.
15940402|NCT03338361|Behavioral|active approach avoidance training and sham visual probe training|patients receive active AAT training and sham VPT training
15940403|NCT03338361|Behavioral|sham approach avoidance training and active visual probe training|patients receive sham AAT training and active VPT training
15940404|NCT03338361|Behavioral|active approach avoidance training and active visual probe training|patients receive active AAT training and active VPT training
15940405|NCT03338361|Behavioral|sham approach avoidance training and sham visual probe training|patients receive sham AAT training and sham VPT training
15940406|NCT03338348|Drug|Vosaroxin|Cycle 1-8: Dose Level 0: 70mg/m², Dose Level -1: 50mg/m², Dose Level -2: 40mg/m², IV over ten minutes, d 1+4 .
15940407|NCT03338348|Drug|Azacitidine|"Cycle 1-8 Azacitidine: 75 mg/m²/d subcutaneously, d 1-7;
~Maintenance with single agent azacitidine at 75 mg/m²/d on days 1-7 until relapse or progression."
15940408|NCT03338335|Drug|prolonged DAPT|Dual antiplatelet therapy will be prescribed for more than 12 months
15940409|NCT03338322|Device|Twisted file adaptive|Endodontic files that are used in preparation of root canals with adaptive motion
15940410|NCT03338322|Device|Reciproc|Endodontic files that are used in root canal preparation with reciprocation motion
15940411|NCT03338309|Other|Instantaneous wave-free ratio measurement|Instantaneous wave-free ratio measurement in order to evaluate functional significance of epicardial stenosis
15940412|NCT03338296|Drug|lorcaserin hydrochloride XR|oral tablet
15940413|NCT03338296|Drug|Placebo|oral tablet
15940414|NCT03338283|Other|Electromassage|Electro-massage that will be performed by a specialist physiotherapist with more than 8 years of experience We use ENDOMED 482 (Enraf Nonius, Spain) for the elecro-massage. the current parameters are: frequency shift at 4000 Hz IFC, 100 Hz AMF in CV mode. We will gradually raise the current intensity until reaching a high level, but not so high as to cause pain or discomfort, nor evident muscle contraction, although a gentle vibration is allowed. The electro-massage was performed on the musculature of the shoulder and neck.
15940415|NCT03338283|Other|Conservatory treatment|The control protocol will combine: (a) thermotherapy with infrared application; (b) active, self-assisted and isometric shoulder exercises, including Codman's pendulum exercises; (c) manual therapy, always in a pain-free range of movement; and (d) ultrasound in pulsatile mode over the acromium and scapulohumeral area.
15940416|NCT03338270|Diagnostic Test|MRI|MRI sequence without intravenous contrast
15940417|NCT03338257|Behavioral|Husky Reads Intervention|The Husky Reads curriculum now includes a series of 10 lessons designed to introduce preschool-age children to MyPlate while improving fruit and vegetable literacy. Each lesson includes reading at least one children's book, an activity or game, and food tasting to complement learning objectives related to MyPlate and fruit/vegetable literacy. Undergraduate students enrolled in the Husky Reads service- learning course at UConn or college students participating in the paid summer internship program deliver the preschool lessons. Each team of 2-3 undergraduate students is assigned 2-3 early care classrooms to visit and deliver Husky Reads lessons to on a weekly basis.
15940418|NCT03338244|Drug|Azithromycin|Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months
15940419|NCT03338244|Drug|Placebo|Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo suspension every 6 months
15940420|NCT03338218|Drug|Volulyte 6%|Solution for infusion
15940421|NCT03338218|Drug|Ionolyte|Solution for infusion
15940422|NCT03338205|Drug|Ketamine|1 mg/kg ketamine bolus IV
15940423|NCT03338192|Other|QST|All participants will undergo quantitative sensory testing for assessment of endogenous pain modulation using painful heat, mechanical, and cold stimuli in a laboratory session lasting approximately 1 hour.
15940424|NCT03338179|Behavioral|Judgement of learning evaluation|The hardware consists of two lists of 30 pairs of French words, each pair of words being composed of a word index and a target word (names of concrete objects). Among the 60 word pairs, 30 are strongly associated items (or easy items, the other 30 being weakly associated or difficult items.
15940425|NCT03338166|Other|LDH serum level|Blood sample to measure LDH as a predictor of Hepatocellular carcinoma treatment outcome
15940426|NCT03338127|Diagnostic Test|renal function test|2 ml blood sample to be investigated for renal function test
15940427|NCT03338114|Drug|FLX-787-ODT (orally disintigrating tablet)|Oral Disintegrating Tablet
15940428|NCT03338075|Radiation|fractionated stereotactic radiotherapy|The regular prescription doses were 52 Gy in 13 fractions or 52.5 Gy in 15 fractions.
15940429|NCT03338062|Diagnostic Test|Hepatobiliary Iminodiacetic Acid (HIDA) scan|HIDA scan was used as the planning scan for SBRT.
15940430|NCT03338049|Device|Veran System|Electromagnetic navigation bronchoscopy and electromagnetic navigation transthoracic needle aspiration
15940431|NCT03338036|Device|Heart Rate Variability Biofeedback|HRV biofeedback constitutes initial training with the android device and application, and HRV training performed at home. This training will occur twice daily, and each session will take five minutes.
15940432|NCT03338036|Device|Neurofeedback|LORETA Z-Score neurofeedback training will occur three times per week with a trained study investigator.
15940439|NCT03337971|Dietary Supplement|PLACEBO|A food-grade proprietary product containing corn starch in powder form, flavoured and instantised to be dissolved in water. Supplied by Dairygold Ingredients, Mitchelstown, Co Cork, Ireland
15940440|NCT03337971|Dietary Supplement|MBPM|A food-grade proprietary product containing per 100g; milk protein (46.4%), carbohydrate (40.6%), fat (0.7%), Vitamin D (2ug); calcium (1840mg) in powder form, flavoured and instantised to be dissolved in water. Supplied by Dairygold Ingredients, Mitchelstown, Co Cork, Ireland
15940441|NCT03337958|Device|Ventilatory re-education|The first day of intervention consisted primarily in ventilatory re-education. During the realization of the technique he was videotaped with a Tablet so that later the patient could be seen and on the video to be able to give him the guidelines for the correction. On the second and third day of the intervention, ventilation re-education was performed and the inhalation technique was subsequently trained.
15940442|NCT03337945|Drug|"Basel phenotyping cocktail capsule"|"Oral intake of Basel phenotyping cocktail capsule and pharmacokinetics (PK) sampling"
15940443|NCT03337932|Drug|Doxycycline 100 milligram Oral Tablet bid, 7 days|Patients will receive doxycycline for 7 days.
15940444|NCT03337932|Drug|Doxycycline 100 milligram Oral Tablet bid, 14 days|Patients will receive doxycycline for 14 days.
15940445|NCT03337932|Drug|Controls without a history of lyme disease.|No intervention.
15940446|NCT03337919|Drug|Nivolumab|Up to 8 cycles of nivolumab
15940447|NCT03337906|Other|Observation|
15940448|NCT03337893|Diagnostic Test|blood pressure|it will be done both right and left arms
15940449|NCT03337880|Other|instrumental delivery|the birth was assisted with an extractor.
15940450|NCT03337867|Device|Magstim Super Rapid2 System|Intermittent theta-burst-stimulation (iTBS) protocol
15940451|NCT03337867|Device|Magstim Super Rapid2 System|Sham stimulation
15940452|NCT03337841|Drug|Pembrolizumab|Each subject will receive administration of pembrolizumab 200mg IV once only before curative treatment such as hepatic resection or radiofrequency ablation, and will receive curative treatment after administration of pembrolizumab. After curative treatment, each subject will receive pembrolizumab 200mg IV every 3 weeks. Treatment will continue until tumor recurrence, occurrence of an unacceptable adverse event, or the 16th treatment with pembrolizumab.( The setting of 16 times administration is the period of adjuvant therapy of this trial is 12 month(=48weeks), administration of pembrolizumab is Q3W, so 16 times administration comes to 48 weeks.)
15940453|NCT03337828|Other|Alcohol-free beer with regular composition|Subjects are provided with 2 alcohol-free beers with regular carbohydrates composition per day and healthy diet counselling during 10 weeks.
15940454|NCT03337828|Other|Alcohol-free beer with modified composition|Subjects are provided with 2 alcohol-free beers with modified carbohydrates composition per day and healthy diet counselling during 10 weeks.
15940455|NCT03337815|Drug|Treatment of MTX and TwHF placebo|Methotrexate: 10-15mg per week according to patient's weight, oral, for 24 weeks.Tripterygium wilfordii Hook F（TwHF）placebo：20mg,3 times a day, oral, for 24 weeks.
15940456|NCT03337815|Drug|Treatment of TwHF and MTX placebo|Tripterygium wilfordii Hook F（TwHF)：20mg,3 times a day, oral, for 24 weeks.Methotrexate (MTX)placebo: 10-15mg per week according to patient's weight, oral, for 24 weeks.
15940457|NCT03337802|Behavioral|mediterranean diet|The Mediterranean diet (MD) is highly regarded as a healthy balanced diet. It is distinguished by a beneficial fatty acid profile that is rich in both monounsaturated and polyunsaturated fatty acids, high levels of polyphenols and other antioxidants, high intake of fiber and other low glycemic carbohydrates, and relatively greater vegetable than animal protein intake. Specifically, olive oil, assorted fruits, vegetables, cereals, legumes, and nuts; moderate consumption of fish, poultry, and red wine; and a lower intake of dairy products, red meat, processed meat and sweets characterize the traditional MD.
15940458|NCT03337789|Dietary Supplement|Polygonatum sibiricum|Polygonatum sibiricum 800mg, 30-60 minutes before sleep, once a day for 4 weeks
15940459|NCT03337789|Dietary Supplement|Placebo|Placebo 800mg, 30-60 minutes before sleep, once a day for 4 weeks
15940460|NCT03337776|Other|WhatsApp message|WhatsApp message will be sent to invite subjects to participate in CRC screening
15940461|NCT03337776|Other|Telephone call|Telephone call will be made to invite subjects to participate in CRC screening
15940462|NCT03337750|Behavioral|Web-PE Therapy|Ten 60-minute psychotherapy sessions over 8 weeks, focused on gradually confronting distressing trauma-related memories and reminders. Web-PE is an internet-based version of prolonged exposure (PE) for posttraumatic stress disorder (PTSD).
15940463|NCT03337737|Dietary Supplement|Extreme Endurance|Study will compare (in a crossover) placebo vs dietary supplement Extreme Endurance.
15940464|NCT03337737|Other|Placebo|
15940465|NCT03337724|Drug|Ipatasertib|Ipatasertib, 400 milligrams (mg), administered orally once a day (QD) on Days 1-21 of each 28-day cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
15940466|NCT03337724|Drug|Paclitaxel|Paclitaxel, 80 mg/square meter (m^2), administered intravenously (IV) on Days 1, 8, and 15 of each 28-day cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
15940467|NCT03337724|Drug|Placebo|Matching placebo, administered orally QD on Days 1-21 of each 28-day cycle until disease progression, intolerable toxicity, elective withdrawal from the study, or study completion or termination.
15940468|NCT03337698|Drug|Atezolizumab|Atezolizumab is administered by IV on Day 1 of each 21 day cycle or on Days 1 and 15 of each 28 day cycle.
15940469|NCT03337698|Drug|Cobimetinib|Cobimetinib is administered orally on Days 1-21 of a 28 day cycle.
15940470|NCT03337698|Drug|RO6958688|"Cycle 1:
~RO6958688 is administered by IV infusion on Days 1, 8, and 15 of a 21 day cycle at increasing dosage.
~Subsequent cycles:
~RO6958688 is administered by IV infusion on Days 1, 8, and 15 of a 21 day cycle."
15940471|NCT03337698|Drug|Docetaxel|Docetaxel is administered by IV on Day 1 of each 21 day cycle.
15940472|NCT03337698|Drug|CPI-444|CPI-444 is administered orally twice daily on Days 1- 21, of a 21 day cycle.
15940473|NCT03337698|Drug|Pemetrexed|Pemetrexed is administered by IV on Day 1 of a 21 day cycle.
15940474|NCT03337698|Drug|Carboplatin|Carboplatin is administered by IV on day 1 of the first 4 or 6 cycles out of a 21 day cycle.
15940475|NCT03337698|Drug|Gemcitabine|Gemcitabine is administered by IV on Days 1 and 8 of the first 4 or 6 cycles out of a 21 day cycle.
15940570|NCT03337087|Other|Laboratory Biomarker Analysis|Correlative studies
15940476|NCT03337698|Drug|Linagliptin|Linagliptin is administered orally once daily on Days 1 to 21 out of a 21 day cycle.
15940477|NCT03337698|Drug|Tocilizumab|Tocilizumab is administered for the management of cytokine-release syndrome in the RO6958688-containing arms.
15940478|NCT03337698|Drug|Ipatasertib|Ipatasertib will be administered orally once a day on Days 1-21 of each 28-day cycle.
15940479|NCT03337698|Drug|Bevacizumab|Bevacizumab is administered by IV on Day 1 of each 21-day cycle.
15940480|NCT03337698|Drug|Sacituzumab Govitecan|Sacituzumab Govitecan is administered by IV on Day 1 and 8 of each 21-day cycle.
15940481|NCT03337698|Other|Radiation|Radiotherapy up to 21 days
15940482|NCT03337698|Drug|Evolocumab|Evolocumab is administered subcutaneously at a dose of 140 mg on Days 1 and 15 of each 28-day cycle.
15940483|NCT03337672|Drug|Dexmedetomidine|Intravenous dexmedetomidine 0.3mcg/kg is slowly infused at 5 minutes before the end of surgery
15940484|NCT03337672|Drug|Midazolam|Intravenous dexmedetomidine 0.03mg/kg is slowly infused at 5 minutes before the end of surgery
15940485|NCT03337659|Other|Family Integrated Care|FICare is a dynamic psycho-educational intervention. The goal of FICare is a change in culture and practice that permits, encourages and supports parents in their parenting role while their infant is receiving health care in a Level II NICU. Underpinned by adult learning and change theories, FICare empowers parents to build their knowledge, skill and confidence so that the family is well-prepared to care for their infant long before discharge.
15940486|NCT03337646|Drug|Lisdexamfetamine Dimesylate|Medication to treat ADHD
15940487|NCT03337633|Behavioral|Menu design|Participants were given 5 minutes to order a hypothetical meal from the assigned test menu by circling all items they wanted to order.
15940488|NCT03337620|Device|Tx360|Tx360 used to deliver active and placebo drug interventions to SPG.
15940489|NCT03337607|Device|rESWT|"rESWT will be performed as follows:
~Four rESWT sessions
~One rESWT session per week
~4 × 1000 radial extracorporeal shock waves (rESWs) per session (1000 rESWs each applied to the left and the right paravertebral muscles above L3 to S1 using the 36-mm applicator, plus 1000 rESWs each applied to the left and the right sacroiliac joint using the 15-mm convex applicator, in prone position of the patient.
~rESWs applied at 15 Hz
~Air pressure of the rESWT device gradually increased during the first 200 rESWs each until the maximum discomfort the patient can tolerate will be reached, followed by 800 rESWs at this air pressure / energy flux density.
~No application of local anaesthetics"
15940490|NCT03337607|Drug|Celecoxib|1 x 200 mg per day for moderate pain (Numerical Rating Scale score 4-6 on an 11-point scale where 0 indicates no pain and 10 indicates worst imaginable pain), or 2 x 200 mg per day (Numerical Rating Scale 7-10), respectively, for four weeks
15940491|NCT03337607|Drug|Eperisone|3 x 50 mg per day for four weeks
15940492|NCT03337594|Drug|Pre-operative MRI with Dotarem|Dotarem® (gadoterate meglumine - Guerbet)
15940493|NCT03337594|Drug|Pre-operative MRI with MultiHance|MultiHance® (gadobenate dimeglumine - Bracco)
15940494|NCT03337594|Procedure|Surgery|Cardiac surgery
15940495|NCT03337581|Drug|Dexmedetomidine|see arms
15940496|NCT03337568|Procedure|allogeneic hematopoietic cell transplantation|perform allogeneic hematopoietic cell transplantation (HCT) using conditioning regimen of busulfan, fludarabine, and antithymocyte globulin
15940497|NCT03337555|Device|McGrath|McGrath videolaryngoscope
15940498|NCT03337555|Device|Pentax|Pentax videolaryngoscope
15940499|NCT03337555|Device|Macintosh|Macintosh direct laryngoscope
15940500|NCT03337542|Biological|AR101|AR101
15940501|NCT03337529|Other|Vitamin C|200 mg Vitamin C will be given on daily basis for 8 weeks
15940502|NCT03337529|Other|Placebo|200 mg placebo will be given on daily basis for 8 weeks
15940503|NCT03337516|Biological|Blood sampling|Blood sampling in order to assess cytarabine pharmacokinetics
15940504|NCT03337516|Genetic|Genetic analysis|Genetic analysis in order to determine genetic polyporphism of Deoxycytidine Kinase and Cytidine Deaminase
15940505|NCT03337503|Drug|THC and CDB in a 1 to 1 ratio|capsule containing cannabis oil
15940506|NCT03337503|Drug|Experimental: THC and CBD in a 1 to 2 ratio|capsule containing cannabis oil
15940507|NCT03337503|Drug|High CBD with trace THC oil|capsule containing cannabis oil
15940508|NCT03337503|Other|placebo|carrier oil capsule
15940509|NCT03337490|Drug|Ivermectin 0.5% Topical Application Lotion|Subjects on Test Product will receive a single dose, 117g, during the study to be applied at baseline.
15940510|NCT03337490|Drug|Ivermectin 0.5% Topical Application Lotion [SKLICE]|Subjects on Reference Product will receive a single dose, 117g, during the study to be applied at baseline.
15940511|NCT03337490|Drug|Placebo 0% Lotion|Subjects on Placebo will receive a single dose, 117g, during the study to be applied at baseline.
15940512|NCT03337477|Drug|Placebo|Suspension administered orally for a treatment period of 24h. 2 sachets administered up to three times over 10h (at 0, 4 and 10h).
15940513|NCT03337477|Drug|Sodium Zirconium Cyclosilicate(ZS)|Suspension administered orally for a treatment period of 24h. Single dose contains 2 sachets of ZS 5g. 10g administered up to three times over 10h (at 0, 4 and 10h).
15940514|NCT03337477|Drug|Insulin|Insulin 0.1 units/kg administered as a bolus or for up to 30 minutes.
15940515|NCT03337477|Drug|Glucose|Glucose 25g administered IV <15 minutes before the insulin.
15940516|NCT03337477|Drug|Insulin|Insulin 0.1 units/kg administered as a bolus or for up to 30 minutes.
15940517|NCT03337477|Drug|Glucose|Glucose 25g administered IV <15 minutes before the insulin.
15940518|NCT03337464|Other|cycling exercise|5 x 3 minute bouts of cycling exercise separated by 3 minute rest periods
15940519|NCT03337451|Drug|OPN-305|Patients will receive study drug every 4 weeks
15940520|NCT03337438|Other|Personalized Feedback Intervention with Values|The PFI with values will include information commonly included in personalized feedback interventions for alcohol use, such as norms information and drinking profile, as well as feedback on three of the assessed values that are highly important to the participant.
15940521|NCT03337438|Other|Personalized Feedback Intervention Traditional|This PFI will include information on drinking profile, norms, behavioral strategies used while drinking, and practical costs related to drinking reframed as monetary values and caloric values.
15940571|NCT03337087|Drug|Leucovorin Calcium|Given IV
15940572|NCT03337087|Drug|Liposomal Irinotecan|Given IV
15940522|NCT03337425|Behavioral|Psychoeducational group therapy|The group-based psychoeducational program consists of 10 sessions, run over 10 consecutive weeks. Each session consist of a lecture, given by a recruited expert on the topic of the session (20 minutes) with a following discussion of the topic (45 minutes), facilitated by the course leader. All sessions are organized and led by the course leader, which also includes keeping structure in time, discussion and closing of the session. Psychoeducation comes in addition to standard treatment (ADHD treatment as usual).
15940523|NCT03337425|Behavioral|Waiting list|Waiting list and standard treatment (ADHD treatment as usual)
15940524|NCT03337425|Other|Standard treatment|Standard treatment consists of diagnostic assessment of ADHD and comorbidity, as well as treatment with medication. In addition, some patients receive cognitive behavioral therapy, although this is not systematically given to every patient. If needed, patients are also offered assistance with regard to economy, housing, education and work. As well as contact with family and network.
15940525|NCT03337412|Other|Adapted physical activity|"Patients will be asked to complete questionnaires about their physical activity, diet and quality of life prior to hospital care.For an evaluation of the chronological evolution of their physical activity, they will be invited to complete the Physical Activity Questionnaire GPAQ 2.0 every 2 months, for the duration of the Research.At 6 months during a telephone contact and at 12 months, during a consultation, the food and quality of life questionnaires will also have to be informed. The evolution of weight, body mass index and metabolic biological factors will also be collected.
~Employees will benefit from a life-health awareness program, accompanied by an APA educator, they are offered the opportunity to participate in physical activity workshops on a regular basis (12 workshops minimum over 6 months), adapted to their abilities and personalized.They will be invited to fill, from their home or on the website Fleury Michon, the same type of questionnaire"
15940526|NCT03337399|Other|Stepped PC|"Palliative Care is involvement of a team of clinicians that specialize in lessening (or palliating) many of these distressing physical and emotional symptoms and in helping patients and their family cope with a serious illness improves patients' and their loved ones' experience with their cancer"
15940527|NCT03337399|Other|Early Integrated PC|"Palliative Care is involvement of a team of clinicians that specialize in lessening (or palliating) many of these distressing physical and emotional symptoms and in helping patients and their family cope with a serious illness improves patients' and their loved ones' experience with their cancer"
15940528|NCT03337386|Diagnostic Test|inferior vena cava collapsibility|inferior vena cava diameters is obtained in the supine position with a convex probe .The probe is placed in the subxiphoid region or the right anterior midaxillary plane.The sagittal section of IVC is imaged. M-mode probe is used to identify the measurement of minimum and maximum venous dimensions over the respiratory cycle using the 3.5-5 MHz phased array probe. To standardize the measurements, measuring of the IVC diameter is performed at 2 cm caudal of the junction point of the right atrium and IVC. The difference between the maximum (D max) and minimum (D min)diameters of the target vein is normalized according to the standard formula to yield the collapsibility index (CI).
15940529|NCT03337386|Diagnostic Test|subclavian vein collapsibility|Right SCV diameters is checked in the supine position using a high frequency linear array probe (6-13 MHz) and M-mode. To standardize the measurements, the probe is placed beneath the proximal part of the middle part of the clavicle perpendicular to long-axis of the SCV to obtain the best cross-sectional view of the vien. After the target vein is localized , the dynamic diameter change is recorded using M-mode to identify and measure the minimum and maximum venous diameters.To calculate SCV collapsibility index, the standard formula is used.
15940530|NCT03337386|Diagnostic Test|central venous pressure|ultrasound guided 7.5-F central venous catheter is introduced via right internal jugular vein under local analgesia with 2% lidocaine for measuring the CVP.
15940531|NCT03337373|Drug|cisatracurium|A single dose of 0.2 mg/kg intravenous bolus cisatracurium will be administered and blood samples will be taken before and at least 7 occasions post dose (at 1, 5, 10, 12, 15, 20, 30, and/or 60 minutes after a single bolus).
15940532|NCT03337360|Dietary Supplement|Impryl|Food supplement with betaine, cystine, zinc, niacin, folic acid (5MTHF-glucosamine), Vitamin B12 (cobalamin), Vitamin B6, Vitamin B2 (riboflavin)
15940533|NCT03337360|Other|Placebo|Inactive ingredients, placebo
15940534|NCT03337347|Device|CTC/DTC count|The presence of CTCs/DTCs in the peripheral blood and/or bone marrow may identify colorectal cancer patients with high risk of disease recurrence who may benefit from adjuvant therapy.
15940535|NCT03337334|Device|tACS at tremor frequency|tACS applied between the stimulation electrodes at tremor frequency
15940536|NCT03337308|Combination Product|Bempedoic Acid + Ezetimibe Fixed-Dose Combination|bempedoic acid + ezetimibe FDC 180 mg/10 mg tablet
15940537|NCT03337308|Drug|Bempedoic Acid|bempedoic acid 180 mg tablet
15940538|NCT03337308|Drug|Ezetimibe|ezetimibe 10 mg overencapsulated tablet
15940539|NCT03337308|Drug|Placebos|placebo tablet or capsule to match bempedoic acid + ezetimibe fixed-dose combination (FDC) 180 mg/10 mg tablet, or bempedoic acid 180 mg tablet, or ezetimibe 10 mg capsule
15940540|NCT03337282|Procedure|Protocolized general anesthesia|Induction and maintenance of general anesthesia, post-operative analgesia with protocolized drugs and doses. Maintenance of MAP +/- 20% of baseline with vasopressors as needed.
15940541|NCT03337269|Other|Educational video|Approximately 7 minute video on the HPV vaccine
15940542|NCT03337269|Other|Educational handout|One page handout on the HPV vaccine
15940543|NCT03337269|Other|Control|Control
15940544|NCT03337256|Diagnostic Test|GI bleeding score|"Risk factor Score component value Age (years) 15-29 -2 30-44 -1.5 45-59 0 60-74 1.5
~75 2.5 Haemoglobin(g/L)
~10.0 0 <9.9 2 Systolic blood pressure (mmHg)
~110 0 90-109 1.5 <90 2.5 Pulse (beats per min) <100 0
~100 1.5 Creatinine (mmol/L) <200 0
~200 3.5 Number of blood transfusion 0 0
~1 1.5
~2 2 Presenting symptom Melaena -1.5 Drug treatment Acid blcoking drug 1.5 anticoagulant 3 Endoscopy findings Clean-based ulcer -2 SRH or blood in stomach 4 Varices 5"
15940573|NCT03337087|Drug|Rucaparib|Given PO
15940574|NCT03337074|Other|Questionnaire, semen sample, fasting blood sample|Participants are asked to complete a questionnaire and provide a semen sample and fasting blood sample.
15940575|NCT03337074|Other|Questionnaire|Participants are asked to complete a questionnaire.
15940576|NCT03337074|Other|Questionnaire, fasting blood sample|Participants are asked to complete a questionnaire and provide a fasting blood sample.
15940577|NCT03337061|Other|Mindfulness Meditation|Mindfulness Meditation delivered through a mobile application
15940545|NCT03337243|Procedure|HAM and HUMCWJ Injections|SURGENEX SurForce® (1cc) allograft placental based tissue matrix, will be injected using a 22 gauge, 2-inch needle. The injection site (medial, lateral, patellar) will be determined based on the side with the most joint space from the findings of the most recent x-rays. The Physician will insert the needle fully into the joint space and begin to expel the fluid. He will achieve a continuous injection flow as he withdraws the needle back out of joint space. Immediately following the SURGENEX SurForce® injection, an injection of Predictive Biotech CORECYTE(TM) (1 cc) allograft umbilical cord-derived Warton's Jelly tissue matrix will be administered. This will be done using the exact same protocol as the SURGENEX SurForce® injection.
15940546|NCT03337230|Behavioral|Physical Activity|Fitbit Activity Monitor and IPAQ to give level of physical activity. Participants will be provided with education about physical activity recommendations and will be encouraged to set goals for improvement.
15940547|NCT03337230|Behavioral|Diet|National Cancer Institute's ASA24 web-based dietary assessment tool to determine intake. Participants will be provided with education about healthy diets and will be encouraged to set goals for making enduring changes to dietary intake.
15940548|NCT03337230|Behavioral|Social Support|Social support will be determined via self report scale measure and objective collection of social media communications. Each participant will be contacted through social media regularly with dietary and physical activity information and asked to support other participants via encouragement and sharing of information.
15940549|NCT03337217|Procedure|Position during colonoscopy|Position during colonoscopy
15940550|NCT03337204|Behavioral|Technology-assisted self-monitoring|Participants receive a Fitbit Zip, an iPad Mini tablet device, training on how to use the Fitbit and iPad, and are asked to complete brief surveys each night on their activity engagement that day (for two 7-day periods).
15940551|NCT03337204|Behavioral|Workshop and Peer Mentoring|Participants receive a 3-hour Engaged4Life Workshop (psychoeducation + goal setting) and one-on-one peer mentoring via phone 2X/week for 3 weeks.
15940552|NCT03337191|Drug|Levobupivacaine|% 0,125 levobupivacaine
15940553|NCT03337191|Drug|Morphine Sulfate|10 mq/kg morphine sulfate
15940554|NCT03337191|Device|Ultrasound|Ultrasound guided caudal block
15940555|NCT03337178|Behavioral|Blinded Fitbit|Fitbit is worn for 3 months post-operatively with no activity feedback or step goals
15940556|NCT03337178|Behavioral|Fitbit|Fitbit is worn for 3 months post-operatively with feedback and step goals
15940557|NCT03337165|Biological|tolerogenic dendritic cells|dose-escalation
15940558|NCT03337152|Drug|primaquine|Participants receive primaquine for 14 days at 0.5 mg/Kg. Drug administration will be directly observed.
15940559|NCT03337152|Drug|chloroquine + primaquine|Participants will receive chloroquine for 3 days concomitant with primaquine for 14 days at 0.5 mg/Kg. Drug administration will be directly observed.
15940560|NCT03337139|Behavioral|Gold Standard Behavior Therapy for Weight Loss|Group-based behavioral treatment for weight loss, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session). Participants will be asked to utilize digital monitoring devices for physical activity, weight, and diet. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.
15940561|NCT03337139|Behavioral|Standard Remote Behavior Therapy for Weight Loss|Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by participant self-report. Coaches will not have access to the digital data that participants provide on physical activity, weight, and diet monitoring devices.
15940562|NCT03337139|Behavioral|Digital Data Sharing Behavior Therapy for Weight Loss|Individual, monthly, brief phone calls with coach and weekly text messages. The content of these calls and messages will be determined by the digital data that has been shared with the coach from physical activity, weight, and diet monitoring devices.
15940563|NCT03337126|Drug|Metronidazole Tablet|Comparator Drug
15940564|NCT03337113|Other|Working Memory Training|The Working Memory Training condition: This condition will include 30 sessions across 4 weeks (10 remote sessions prior to initiation of the rTMS stimulation, and 20 lab sessions on rTMS stimulation days). Participants will complete three distinct WM tasks in each session: a visuospatial WM task, a backward digit span task, and a letter span task. In the training condition, the difficulty level of all three WM tasks will be automatically adjusted on a trial-by-trial basis. An identical protocol and software have demonstrated efficacy in increasing WM capacity, and this improvement in WM predicts reduction in addictive behavior.
15940565|NCT03337113|Other|Sham Working Memory Training|In the Sham WMT condition, the difficulty level of the WM tasks will not be adjusted; instead it will remain at the initial easy level throughout each task (i.e., three items in each sequence). All other aspects of the condition are identical to the active WMT condition.
15940566|NCT03337113|Device|repetitive Transcranial Magnetic Stimulation|"The rTMS Condition: rTMS will be delivered with a Magstim Rapid2 system using Magstim Air Film Coils. rTMS pulses will be delivered at 10 Hz (100% resting motor threshold, RMT) in 40, 5 second trains, with 15 second inter-train interval, for a total of 2000 pulses per session. Active or sham rTMS will be applied over the left DLPFC; corresponding with the standard F3 location on scalp (F3=left frontal lobe, location #3 for electrode placement using international 10-20 system for scalp measurements). Five consecutive daily sessions will occur on two consecutive weeks, for a total of 10 sessions. RMT, defined as the amount of energy required to induce movement in the contralateral abducer pollicis brevis in at least 50% of stimulations, will be assessed on first day of application."
15940567|NCT03337113|Device|Sham repetitive Transcranial Magnetic Stimulation|Sham rTMS will be identical to active treatment, with the exception that mu-metal plates attached to the sham coil block the magnetic field while providing a sensation of stimulation.
15940568|NCT03337100|Behavioral|Co-Dispensing|"Implementation of a naloxone co-dispensing pharmacy program.
~The intent of this program is to provide patients prescribed chronic opioid therapy naloxone under the terms of a standing order for potential opioid overdose reversal. Prior to implementing the program, a naloxone standing order will be implemented and pharmacy operational staff will provide training to pharmacy staff about the standing order and a naloxone co-dispensing protocol. Under a co-dispensing protocol, pharmacy staff members will identify opioid prescriptions meeting criteria for co-dispensing, prepare naloxone fills, offer patients naloxone, and provide counseling on its use."
15940569|NCT03337087|Drug|Fluorouracil|Given IV
15940579|NCT03337035|Drug|intranasal oxytocin|4-24 IU per day, dosage gradually increases
15940580|NCT03337035|Dietary Supplement|oral probiotics|200 million cfu per day
15940581|NCT03337035|Dietary Supplement|oral placebo|2 pills per day
15940582|NCT03337022|Drug|CC-90006|CC-90006
15940583|NCT03337022|Other|Placebo|Placebo
15940584|NCT03337009|Behavioral|Naloxone Navigator (NN)|Patients prescribed chronic opioid therapy will be identified and recruited to enroll in the study. Patients randomized to receive the web-based animated video (Naloxone Navigator) will be sent a link to the video after enrollment. The web-based, animated video provides education on what is an opioid overdose, how to prevent it, how to recognize an overdose, and how to respond with naloxone. This video also encourages patients to pick up naloxone from a pharmacy under a standing order.
15940585|NCT03336996|Biological|stem cell transplantation|the motor nerve fiber damaged patient receive a treatment course stem cell transplantation after the hematoma removal.
15940586|NCT03336996|Procedure|BOLD-fMRI drived DTI scanning|All patients should be receive cranial BOLD-fMRI drived DTI scanning scanning separately before the transplant and after the transplant 0, 1, 3, 6 and 12 months.
15940587|NCT03336983|Drug|Zoledronic Acid|Prostate cancer patients with hormone sensitive metastatic bone disease will be treated with LHRH-A + Enzalutamide in the presence or absence of Zoledronic Acid
15940588|NCT03336983|Drug|Enzalutamide|Patients from both arms will be treated with LHRH-A + Enzalutamide
15940589|NCT03336970|Other|EDTA|
15940590|NCT03336970|Other|NaOCl|
15940591|NCT03336970|Other|CHX|
15940592|NCT03336970|Other|Calcium hydroxide|
15940593|NCT03336957|Procedure|periodontal treatment|non-surgical periodontal therapy (NPT) consisted of scaling, root planning, and oral hygiene instruction
15940594|NCT03336931|Diagnostic Test|Molecular profiling and drug testing|"Laboratory analysis including:
~A. Tumour molecular profiling: targeted whole exon variant analysis, whole genome (DNA) and transcriptome (RNA) sequencing, methylation analysis, proteomics analysis, immunohistochemistry B. In vitro high-throughput drug sensitivity testing C. In vivo drug testing using patient-derived xenograft (PDX) models D. Liquid biopsies
~Multi-disciplinary Tumour Board case discussion
~Recommendation of personalised therapy"
15940595|NCT03336918|Drug|Lithium|"Open-label lithium treatment for Bipolar Disorder Subjects
~Healthy Controls only repeat testing - no intervention"
15940596|NCT03336905|Other|Physical activity program and prevention after cancer|Providing a supervised and non-supervised physical activity program for adolescent and Young adult with cancer and improve awareness on cancer prevention recommendations (second cancer risk, healthy lifestyles...)
15940597|NCT03336892|Behavioral|Mental Health Care Coordination|Enhanced usual care with written mental health resources and system navigation information in addition to individualized mental health care coordination by a dedicated specially trained mental health care coordinator.
15940598|NCT03336879|Device|Repetitive Transcranial Magnetic Stimulation|Repetitive Transcranial Magnetic Stimulation (rTMS) is a non-invasive brain stimulation technique. The investigators will use a MagPro R30 with the Cool-B80 figure-of-eight coil (MagVenture, Falun, Denmark).
15940599|NCT03336866|Drug|Placebo|Normal saline
15940600|NCT03336866|Drug|IXT-m200|IXT-m200 is an anti-methamphetamine monoclonal antibody
15940601|NCT03336853|Device|HybenX|"The material was introduced inside the root canal using the pre-dosed syringe for 20 seconds with a sterile paper point with and up and down movement up to the working length.
~Finally, the canal was rinsed with sterile water using a syringe with a side-vented 30 G needle 1 mm shorter than the working length.
~A second sterile paper point was introduced in the root canal, up to the working length, for 10 seconds to detect the presence of blood and the millimeters of blood inside the root canal was measured again according the previous criteria."
15940602|NCT03336853|Other|Placebo control|"The root canal was irrigated with sterile saline water with a syringe and a side-vented 30G needle activated for 20 seconds with a sterile paper point with and up and down movement up to the working length to ensure a flow of irrigant solution throughout the canal.
~Finally, the canal was rinsed with sterile water using a syringe with a side-vented 30 G needle 1 mm shorter than the working length. A second sterile paper point was introduced in the root canal, up to the working length, for 10 seconds to detect the presence of blood and the millimeters of blood inside the root canal was measured again according the previous criteria."
15940603|NCT03336840|Drug|Metformin tablets|0.5g (1 pill) of Metformin tablets administered three times a day orally before meal
15940604|NCT03336840|Drug|ProMetS probiotics powder|4g (2 strips) of ProMetS probiotics powder administered orally every night
15940605|NCT03336840|Drug|1. Metformin tablets; 2. ProMetS probiotics powder|"0.5g (1 pill) of Metformin tablets administered three times a day orally before meal;
~4g (2 strips) of ProMetS probiotics powder administered orally every night"
15940606|NCT03336827|Behavioral|Cognitive-Behavioral Group Therapy and Hypnosis|The intervention consists in a pre-group interview and eight 2,5 h-session extended over 4 months. The intervention is based on cognitive-behavioral group therapy and hypnosis. To promote use of hypnosis at home, patients will receive audiorecordings of the hypnosis exercises. Starting immediately after the pre-group interview, the group will receive 3 app prompts a day promoting self-awareness and modulation of internal states, orientation of attention toward positive stimuli and inviting them to increase physical activity. Patients will be given a patient manual to promote an active approach to changes.
15940607|NCT03336827|Behavioral|Cognitive-Behavioral Group Therapy and Hypnosis|The intervention consists in a pre-group interview and eight 2,5 h-session extended over 4 months. The intervention is based on cognitive-behavioral group therapy and hypnosis. To promote use of hypnosis at home, patients will receive audiorecordings of the hypnosis exercises. Starting immediately after the pre-group interview, the group will receive 3 app prompts a day promoting self-awareness and modulation of internal states, orientation of attention toward positive stimuli and inviting them to increase physical activity. Patients will be given a patient manual to promote an active approach to changes.
15940608|NCT03336814|Drug|Terlipressin|Administration of terlipressine
15940609|NCT03336814|Other|Placebo|Administration of placebo
15940610|NCT03336801|Procedure|Back Surgery|All patients undergo basic back surgery.
15940611|NCT03336801|Drug|Propofol|Anesthesia on propofol alone.
15940612|NCT03336801|Drug|Sevoflurane|Anesthesia on sevoflurane alone.
15941857|NCT03327740|Drug|DTG based ARV regimen with ABC|ARV regimens containing DTG and ABC
15940613|NCT03336788|Device|Transcranial Magnetic Stimulation (TMS - ) MagPro®|20 sessions navigated with Conventional Transcranial Magnetic Stimulation
15940614|NCT03336788|Device|virtual reality for displaying interactive virtual environments|20 sessions navigated with virtual reality
15940615|NCT03336775|Procedure|acupuncture|Acupuncture for 30 minutes per day for up to 20 sessions (over 4 weeks).
15940616|NCT03336762|Diagnostic Test|Intra spinal pressure monitoring|Sub dural pressure monitoring using a FDA approved intracranial pressure monitor
15940617|NCT03336762|Diagnostic Test|Intra spinal microdialysis monitoring|Sub arachnoid microdialysis monitoring using a FDA approved hepatic microdialysis catheter
15940618|NCT03336749|Behavioral|Sensory group|The sensory re-learning consists of touch detection practice, i.e., touch discrimination to identify different materials, shapes, textures, weights and temperatures, proprioception and tactile object recognition in combination with task-specific training.
15940619|NCT03336749|Other|Control group|Traditional task-specific training
15940620|NCT03336736|Diagnostic Test|Exercise|"The study design will be a prospective cross-sectional observational project, with no intervention.
~Data on a participant's physical activity levels, physical fitness and quality of life will be collected using physical testing and questionnaires."
15940621|NCT03336723|Device|Dental Implant|Place a two piece zirconia dental implant on a healed ridge. At baseline, two month and crown placement take fluid samples with adsorbent paper in the per- implant crevicular fluid. At t2 and t3 repeat sample taken
15940622|NCT03336697|Diagnostic Test|Nasal swab|a nasal swab will be performed by a trained physician by gently passing of a cotton swab in the nasal passage to get samples from middle meatus. This will be performed under guide of nasal anterior endoscopy to visualize the location of sampling. The cotton swab heads will be placed in sterile tubes and frozen at -80°C until DNA extraction.
15940623|NCT03336684|Behavioral|Patient education|Rheumatoid arthritis patients will be provided with disease education literature
15940624|NCT03336671|Procedure|Endoscopic Sinus surgery|Endoscopic sinus surgery would be tailored to abnormal findings in the CT scan, as is the standard of care. Radiologists typically examine sinonasal disease of the sinuses, and they would also be requested to comment on the patency of the osteo-meatal unit, as this is a component of the Lund-McKay score. The Lund-McKay score is an objective radiologic grade of the severity of sinusitis. If there is sinus thickening, or narrowing of the OMU, endoscopic sinus surgery would be tailored to this using either balloon sinuplasty or traditional antrostomy. Patient undergoing endoscopic sinus surgery will likely have at least a maxillary antrostomy and anterior ethmoidectomy performed, with frontal sinusotomy, posterior ethmoidectomy, and sphenoidotomy performed depending on CT or endoscopy findings.
15940625|NCT03336671|Procedure|Adenoidectomy|Adenoidectomy performed, routine, as a singular procedure not combined with any sinus surgery.
15940626|NCT03336645|Drug|SHP615|SHP615 oromucosal solution will be administered as a single age-specific dose (2.5, 5, 7.5 and 10 mg).
15940627|NCT03336632|Drug|Chidamide|20 mg orally, twice weekly from D-7 to D+14
15940628|NCT03336632|Drug|Cyclophosphamide|50 mg/Kg intravenously D+3, +4
15940629|NCT03336632|Drug|cyclosporine A|3 mg/Kg intravenously then orally from D+5 to D+100 if no acute graft-versus-host disease
15940630|NCT03336619|Drug|Nitazoxanide|Nitazoxanide 600 mg administered orally twice daily for five days
15940631|NCT03336619|Drug|Placebo|Placebo administered orally twice daily for five days
15940632|NCT03336606|Drug|MEDI0562|Surgical resection of tumor
15940633|NCT03336593|Biological|Quadrivalent Influenza Vaccine|1 or 2 doses of Quadrivalent Influenza Vaccine depends on age
15940634|NCT03336593|Biological|Trivalent Influenza Vaccine|1 dose of Trivalent Influenza Vaccine
15940635|NCT03336580|Drug|PRX004|"PRX004 (0.1, 0.3, 1, 3, 10, and 30 mg/kg) IV every 28 days
~PRX004 IV every 28 days at RP2D(s)
~PRX004 IV every 28 days at RP2D(s)"
15940636|NCT03336567|Other|Telephonic interview|Subjects with cancer and Oncologists will undergo a semi-structured one-to-one telephonic interview for up to 90 and 60 minutes respectively.
15940637|NCT03336541|Drug|Ketamine|Ketamine (0.5 mg/kg in 100 ml normal saline) will be administered by intravenous infusion in 40 minutes after childbirth during cesarean delivery.
15940638|NCT03336541|Drug|Placebo|Placebo (100 ml normal saline) will be administered by intravenous infusion in 40 minutes after childbirth during cesarean delivery.
15940639|NCT03336528|Drug|Degludec|Degludec is a long-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus. Patients will be treated with bolus regimen given half of total daily dose (TDD) as basal once daily and half as aspart divided in three equal doses before meals. Patients with poor oral intake or with medical instruction to withhold oral intake (NPO) will receive the basal dose, but prandial dose will be held. Insulin dose will be adjusted daily to maintain a fasting and pre-dinner BG between 100 mg/dl and 180 mg/dl.
15940640|NCT03336528|Drug|Glargine|Glargine is a long-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus. Patients will be treated with bolus regimen given half of total daily dose (TDD) as basal once daily and half as aspart divided in three equal doses before meals. Patients with poor oral intake or with medical instruction to withhold oral intake (NPO) will receive the basal dose, but prandial dose will be held. Insulin dose will be adjusted daily to maintain a fasting and pre-dinner BG between 100 mg/dl and 180 mg/dl.
15940641|NCT03336528|Drug|Aspart|Aspart insulin will be given in three equally divided doses before each meal. To prevent hypoglycemia, if a subject is not able to eat, aspart insulin dose will be held.
15940642|NCT03336528|Drug|Degludec post-discharge|Patients with an HbA1c between 7.5% and 10% will be discharged on preadmission oral antidiabetic agents plus degludec once daily. Patients with an admission A1C ≥ 10% will be discharged on basal bolus regimen with degludec and aspart insulin before meals.
15940643|NCT03336528|Drug|Glargine U100 post-discharge|Patients with an admission A1C ≥ 10% will be discharged on basal bolus regimen with glargine and aspart insulin before meals.
15940644|NCT03336515|Device|Group C-Postural device activated|General recommendation not sleeping in supine position and the postural device activated (intervention group).
15940645|NCT03336515|Device|Group B-Postural device no activated|General recommendation not sleeping in supine position and the postural device without any activation (placebo)
15940646|NCT03336515|Behavioral|Group A-General Recommendation|General recommendation not sleeping in supine position
15976792|NCT03061058|Drug|Irinotecan|intraperitoneal and/or intravenous
15940647|NCT03336502|Drug|Posaconazole|Posaconazole 18 mg/mL IV solution; posaconazole 40 mg/mL oral suspension
15940648|NCT03336476|Device|Videolaryngoscopy|Patients will be intubated with the video laryngoscope
15940649|NCT03336476|Device|Direct laryngoscopy|Patients will be intubated with the direct laryngoscope
15940650|NCT03336450|Drug|SHP615|SHP615 oromucosal solution will be administered as a single age-specific dose (2.5, 5, 7.5 and 10 mg).
15940651|NCT03336450|Drug|MHOS/SHP615|MHOS/SHP615
15940652|NCT03336437|Drug|Estradiol vaginal ring|Estradiol 2mg vaginal ring
15940653|NCT03336437|Other|Placebo vaginal ring|Silicone vaginal ring without any active estradiol
15940654|NCT03336424|Diagnostic Test|Non-invasive investigations|Ultrasound, blood tests, urine analysis and culture, uroflowmetry
15940655|NCT03336424|Diagnostic Test|Invasive investigations|Cystomanometry, pressure flow study, EMG
15940656|NCT03336411|Behavioral|mHealth|Behavioral weight loss intervention using behavioral counseling focusing on physical activity and a one-size-fits-all, calorie-restricted, diet.
15940657|NCT03336411|Behavioral|Personalized mHealth|Behavioral weight loss intervention with personalized dietary recommendations based on machine learning algorithm that integrates gut microbiota, dietary intake, physical activity and various blood parameters to predict postprandial glycemic response.
15940658|NCT03336398|Drug|Ketamine Hydrochloride in saline|0.5 mg/kg IV of ketamine hydrochloride in saline will be administered with one of the MRS Scan
15940659|NCT03336398|Drug|Saline|Saline will be administered with the other MRS scan
15940660|NCT03336385|Dietary Supplement|Naxus|Non-digestible polysaccharides arabinoxylan (Naxus)
15940661|NCT03336385|Dietary Supplement|Oatwell|Non-digestible polysaccharides oat beta-glucan (Oatwell)
15940662|NCT03336385|Dietary Supplement|Placebo|Maltodextrin as placebo
15940663|NCT03336372|Drug|Picato|Picato 0.05% or 0.015% topical gel applied nightly for 3 consecutive nights
15940664|NCT03336359|Diagnostic Test|Tandem colonoscopy|Different image enhanced endoscopy systems
15940665|NCT03336346|Drug|dolutegravir|HIV integrase strand transfer inhibitor used in combination ART
15940666|NCT03336346|Device|ENG implant|Reversible contraception implant
15940667|NCT03336346|Drug|Efavirenz|non-nucleoside reverse transcriptase inhibitor used in combination ART
15940668|NCT03336333|Drug|Zanubrutinib|Administered as two 80-mg capsules by mouth twice a day (160 mg twice a day)
15940669|NCT03336333|Drug|Bendamustine|Administered intravenously (IV) at a dose of 90 mg/m2/day on the first 2 days of each cycle for 6 cycles.
15940670|NCT03336333|Drug|Rituximab|Administered intravenously (IV) at a dose of 375 mg/m2 on day 0 of cycle 1, and at a dose of 500 mg/m2 on day 1 of cycles 2 to 6.
15940671|NCT03336333|Drug|Venetoclax|400mg tablets administered orally once daily.
15940672|NCT03336320|Device|ICT Multidomain Intervention Training|Intervention composed of cognitive training (reasoning and memory training), nutritional counselling (advices to raise awareness about the importance of promoting a diversified and balanced diet), and physical exercises (program and monitoring of progression). The access of control group to the website will be limited to general information about eMIND study and links to the website of health authorities regarding to the healthy ageing topics.
15940673|NCT03336307|Other|Rehabilitation program|"all patients received a rehabilitation program planned according to the European Physiotherapy guideline for Parkinson's disease and focus on:
~endurance, strength, flexibility and balance with functional practice for all H/Y stage
~endurance also for H/Y stage 1,
~motor learning principles and cue functional for H/Y stage 2-3
~external cues and self-instruction strategies and attention H/Y for stage 2-3 The rehabilitative program comprised 60-minute sessions a day (3d/wk)."
15940674|NCT03336294|Radiation|SRM P31|All the volunteers involved in the CAMUS study will perform during the SRM P31 a quadricipital physical task at 70% 1-RM.
15940675|NCT03336281|Drug|Ustekinumab|All participants will receive ustekinumab at study entry. Ustekinumab will not be provided by the sponsor. The treatment decision must have been taken by the investigator prior to, and independently of the participant's inclusion into the study following the standard clinical practice. Only data available from a participant's source medical records will be collected.
15940676|NCT03336268|Behavioral|POINT|A recovery coach meets patients in the ED after they have been revived from an overdose to offer a range of services including an assessment of high-risk behaviors, Hep C/HIV testing, harm reduction counseling, and treatment referrals with follow-up to either a medication assisted treatment (MAT) provider, detoxification services, or an inpatient treatment setting. Patients are offered a take-home naloxone kit and assistance with Medicaid enrollment. Close collaboration with the local community mental health provider ensures POINT patients have their first assessment for MAT within 1-2 business days of ED discharge. Also, recovery coaches offer to accompany patients to intake appointments or criminal justice and child welfare meetings as part of the standard care they deliver.
15940677|NCT03336255|Behavioral|South Asian Healthy Lifestyle Initiative (SAHELI)|Culturally tailored lifestyle intervention for South Asians.
15940678|NCT03336242|Drug|Cannabidiol Oral Solution|An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
15940679|NCT03336229|Behavioral|Exercise intervention|Graduated walking programme, strengthening exercises and respiratory muscle training.
15940680|NCT03336216|Biological|Cabiralizumab|specified dose on specified days
15940681|NCT03336216|Drug|Nab-paclitaxel|specified does on specified days
15940682|NCT03336216|Drug|Onivyde|specified dose on specified days
15940683|NCT03336216|Biological|Nivolumab|specified dose on specified days
15940684|NCT03336216|Drug|Fluorouracil|specified dose on specified days
15940685|NCT03336216|Drug|Gemcitabine|specified dose on specified days
15940686|NCT03336216|Drug|Oxaliplatin|specified dose on specified day
15940687|NCT03336216|Drug|Leucovorin|Specified dose on specified days
15940688|NCT03336216|Drug|Irinotecan Hydrochloride|Specified dose on specified days
15940689|NCT03336203|Drug|Febuxostat 80 MG Oral Tablet or Allopurinol 300 MG Oral Tablet|treatment either with allopurinol or febuxostat
15940690|NCT03336190|Behavioral|avatar-based training|Interaction with an avatar-based module to practice skills learned during the toolkit training
15940761|NCT03335670|Drug|[68Ga]Pentixafor|68Ga Pentixafor is a radiolabeled cyclic pentapeptide with high affinity for CXCR4 receptor
15940691|NCT03336177|Other|Semi-structured face to face interviews.|Patients will be interviewed by open-ended questions face to face concerning their past experiences. The recorded interview will be transcribed and analyzed by psychodynamic and semio-pragmatic approach.
15940692|NCT03336164|Behavioral|Front-of-pack labelling Nutri-Score|Introduction of the Nutri-Score front-of-pack nutrition label on shelf display tags for every food and beverage sold in the university restaurant
15940693|NCT03336151|Behavioral|Front-of-pack labelling Nutri-Score|Introduction of the Nutri-Score front-of-pack nutrition label on shelf display tags for every food and beverage sold in the cafeteria
15940694|NCT03336138|Other|AMA (Assistance for ambulatory patients)|telephone follow-up modality
15940695|NCT03336125|Dietary Supplement|Vitamin D|Vitamin D (40µg/day) will be compared with placebo
15940696|NCT03336125|Dietary Supplement|Placebo|120 mg olive oil
15940697|NCT03336112|Behavioral|Internet-delivered cognitive behavioral therapy (I-CBT)|The intervention (I-CBT) will consist of 5 weeks of Internet-delivered cognitive behavioral therapy using three main parts. The first is psychoeducation that aims to educate the patients about chest pain and other causes than the cardiac ones. The other part concerns avoidance and exposure. This includes exposing the patients to physical activities that patients perceive as a threat to the heart. The third part contains awareness (mindfulness) training to teach the patients to have contact with the present moment despite chest pain and not trying to avoid it.
15940698|NCT03336112|Other|Information program|Information program delivered by the Internet during 5 weeks.
15940699|NCT03336099|Other|Spa Treatment|"Bath with immersion shower
~Overall shower, penetrating shower
~Multiple local application cataplasm
~Single local application cataplasm
~Inhalation or collective steam bath
~Individual physiotherapy technique"
15940700|NCT03336086|Combination Product|weight loss program|A low calorie diet+ Orlistat+ Soluble Fiber+ Physical activity
15940701|NCT03336073|Drug|Carfilzomib|carfilzomib at a dose of 70 mg/m2 (20 mg/m2 only in the first infusion) intravenously (iv) on days 1, 8, and 15
15940702|NCT03336073|Drug|Dexamethasone|dexamethasone oral at a dose of 20 mg (10 mg for patients >75 years) days 1, 2, 8, 9, 15 and 16
15940703|NCT03336073|Drug|cyclophosphamide|cyclophosphamide at a dose of 300 mg/m2 iv on days 1, 8 and 15
15940704|NCT03336060|Diagnostic Test|Cortical Correlates of Jump Landing Task|The study participants perform counter-movement jumps (CMJ, flight time approximately 500 ms) followed by single leg landings. While under an anticipated condition, the individuals receive the visual information (presented on a screen) on which leg/ foot (left, right) they are required to land before self-initiated CMJs, the individuals will receive this information under the non-anticipated condition only after take-off (approximately 400 ms before ground contact).
15940705|NCT03336047|Behavioral|personal activity intelligence|"Participants randomized to the PAI intervention will receive a Mio Slice fitness bracelet and asked to install the Mio Pai 2.0 app on their smart phone. This tracks their fitness score based on the PAI algorithm where the goal is to maintain 100 PAI points a week. PAI is earned incrementally based on time spent in three different heart rate zones, low, medium and high intensity. PAI is recorded every day and added to the weekly total and the PAI earned on the same day the previous week is deleted (on Tuesday, the PAI earned the previous Tuesday will disappear).
~Participants will be encouraged to maintain 100 PAI during the 8 weeks intervention by telephone messages (sms)."
15940706|NCT03336047|Behavioral|10,000 steps daily|Participants randomized to the 10,000 step intervention will receive a fit bit zip step counter and asked to obtain 10.000 steps per day. Participants will be encouraged to obtain 10.000 steps per day by telephone messages (sms).
15940707|NCT03336021|Other|FAS program|Intervention households are farmers who will receive a forward contract through the FAS program; in addition, they may receive other support such as extension, seeds, etc.
15940708|NCT03336008|Other|no intervention|No intervention but clinical assessement for all recruited subjects
15940709|NCT03335982|Procedure|transendoscopic enteral tubing in mid-gut|A TET tube was inserted into mid-gut through the nasal orifice and fixed on the pylorus wall by one tiny titanium endoscopic clip under anesthesia.
15940710|NCT03335969|Device|colon irrigation|Study is to compare bowel movement patterns before and after colon irrigation.
15940711|NCT03335956|Drug|CORT125281, 40mg, fasted|CORT125281 is supplied as capsules for oral dosing
15940712|NCT03335956|Drug|Prednisone 25mg, fasted|"Challenge Agent, Dose and Route of Administration:
~Standard release 25 mg tablets, orally administered"
15940713|NCT03335956|Drug|Placebo oral capsule, fasted|"Reference Therapy, Dose and Route of Administration:
~Placebo capsule, orally administered"
15940714|NCT03335956|Drug|Pioglitazone 15mg Tablet|"Probe Substrate, Dose and Route of Administration:
~15 Mg tablet, orally administered"
15940715|NCT03335956|Drug|Placebo oral capsule, fed|"Reference Therapy, Dose and Route of Administration:
~Placebo capsule, orally administered"
15940716|NCT03335956|Drug|Prednisone 25mg, fed|"Challenge Agent, Dose and Route of Administration:
~Standard release 25 mg tablets, orally administered"
15940717|NCT03335956|Drug|CORT125281, 120mg, fasted|CORT125281 is supplied as capsules for oral dosing
15940718|NCT03335956|Drug|CORT125281, 360mg, fasted|CORT125281 is supplied as capsules for oral dosing
15940719|NCT03335956|Drug|CORT125281, 720mg, fasted|CORT125281 is supplied as capsules for oral dosing
15940720|NCT03335956|Drug|CORT125281, 360mg, fed|CORT125281 is supplied as capsules for oral dosing
15940721|NCT03335956|Drug|CORT125281, 360mg|CORT125281 is supplied as capsules for oral dosing twice, 12 hours apart, fasted (morning) and after evening meal
15940722|NCT03335956|Drug|CORT125281, 120mg|CORT125281 is supplied as capsules for oral dosing once daily
15940723|NCT03335956|Drug|CORT125281, 180mg|CORT125281 is supplied as capsules for oral dosing twice daily
15940724|NCT03335956|Drug|CORT125281, 240mg|CORT125281 is supplied as capsules for oral dosing twice daily
15940725|NCT03335956|Drug|CORT125281, 360mg|CORT125281 is supplied as capsules for oral dosing once daily
15940726|NCT03335956|Drug|Placebo oral capsule|"Reference Therapy, Dose and Route of Administration:
~Placebo capsule, orally administered twice, 12 hours apart, fasted (morning) and after evening meal"
15940727|NCT03335956|Drug|Placebo oral capsule|"Reference Therapy, Dose and Route of Administration:
~Placebo capsule, orally administered, twice daily"
15940728|NCT03335956|Drug|Placebo oral capsule|"Reference Therapy, Dose and Route of Administration:
~Placebo capsule, orally administered, once daily"
15940729|NCT03335943|Drug|CDA-2 (Cell Differentiation Agent 2)|CDA-2 will be given intravenously, with 200 ml each day for 14 consecutive days in every four weeks (one cycle). The treatment will be repeated at least for 3 cycles.
15940730|NCT03335930|Behavioral|a 12-week moderate-intensity exercise training|a 12-week, aerobic, moderate-intensity exercise training
15940731|NCT03335917|Other|Hypoxia|Participants will be exposed to hypoxia by reducing barometric pressure or by reducing oxygen concentration
15940732|NCT03335917|Other|Exercise|Graded cycling exercise to volitional fatigue
15940733|NCT03335904|Other|Hyperoxic Hypercapnic Ventilatory Response Test|End-tidal PO2 will be clamped at 300 mmHg while end-tidal PCO2 will be increased in three minutes stages from baseline to +2, +4, and +6 mmHg.
15940734|NCT03335904|Other|Hypoxic Hypercapnic Ventilatory Response Test|End-tidal PO2 will be clamped at normoxic levels while end-tidal PCO2 will be increased in three minutes stages from baseline to +2, +4, and +6 mmHg.
15940735|NCT03335904|Other|Repeated Hypoxic Apneas|Six hypoxic apnea cycles will be performed. One apneic cycle involves breathing 2-3 breaths of 100% Nitrogen and breath-holding for 20s followed by room air breathing.
15940736|NCT03335904|Other|Hypoxic Sleep Study|Participants will be instrumented with a sleep monitoring system and will sleep in a normobaric hypoxic chamber with a fraction of inspired oxygen of 13.5%.
15940737|NCT03335904|Drug|Losartan|Losartan, 50mg, BID
15940738|NCT03335904|Drug|Placebo|Placebo, 50mg, BID
15940739|NCT03335891|Procedure|Core Stabilization Exercises|Volunteers received an asthma education program and trained for diaphragmatic, pursed lip breathing exercises as well as participated in the core stabilization exercises program.
15940740|NCT03335891|Procedure|Control|Volunteers received an asthma education program and trained for diaphragmatic andpursed lip breathing exercises
15940741|NCT03335852|Drug|Abicipar pegol|Abicipar pegol 2 mg administered to the study eye by intravitreal injection
15940742|NCT03335839|Drug|tissue plasminogen activator|Recombinant tPA is a fibrin-specific 2nd generation plasminogen activator and thrombolytic drug.
15940743|NCT03335839|Other|Saline|Placebo
15940744|NCT03335826|Procedure|Combined epidural-general anesthesia|Combined epidural-general anesthesia and postoperative epidural analgesia.
15940745|NCT03335826|Procedure|General anesthesia|General anesthesia and postoperative intravenous analgesia.
15940746|NCT03335813|Device|Endoesophageal Brachytherapy|Balloon repositioning, multichannel brachytherapy applicator which has 6 channels instead of 3-tubes which will be used to deliver localized radiation
15940747|NCT03335800|Device|Apple Heart Study App|The Apple Heart Study app is a mobile medical app that analyzes pulse rate data. The app identifies episodes of irregular heart rhythms consistent with atrial fibrillation and other arrhythmias.
15940748|NCT03335787|Other|Intervention|Kinesio Tape apply to peroneal muscles in supine position starting from the peroneal muscle origin with using muscle activation technique by a certified KT1 and KT2 practitioner. Then ligament technique which will go through around ankle starting from medial and lateral metatarsophalangeal joints in order to improve ankle stability. Taping will be applied one week later and two weeks later prior to first application.
15940749|NCT03335787|Other|Control|Any sham taping was not applied to the control group in order to prevent the sensory stimulant effect of taping. In order to achieve patients' blinding both groups participant will sign a same consent but control group will be called for taping a month later after study data collection completed.
15940750|NCT03335774|Drug|Hydrocortisone Acetate Suppository, 25 mg|One (1) Hydrocortisone Acetate Suppository, 25 mg is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).
15940751|NCT03335774|Drug|Placebo (Vehicle) Suppository|One (1) Placebo (Vehicle) Suppository is inserted into the anal canal twice daily (morning and evening) for 2 weeks (14 days).
15940752|NCT03335761|Device|InterStim Therapy|Device Programming
15940753|NCT03335748|Other|Cognitive training Cogmed program|Cognitive training Cogmed program
15940754|NCT03335735|Behavioral|Loss-framed text message|Participants in the intervention group will receive loss-framed text messages related to drinking and driving on days during the week with a higher likelihood of alcohol consumption (Thursday-Saturday). Loss aversion refers to people's tendency to prefer avoiding losses to acquiring equivalent gains: it's better to not lose $5 than to find $5, so the content of the messages will be related to loss of personal freedom, loss of money, and loss of future employment opportunities due to Driving Under the Influence (DUI) convictions.
15940755|NCT03335735|Behavioral|Gain-Framed text message|Participants in the intervention group will receive gain-framed text messages related to drinking and driving on days during the week with a higher likelihood of alcohol consumption (Thursday-Saturday). Gain-framed messages have been shown to have a positive effect on preventative healthcare and include content framed in a manner that the participant gains something from taking preventative action. Message content will be related to saving lives, gaining control, and making loved ones happy.
15940756|NCT03335722|Behavioral|Metronome-timed speech|Reading, narrative, and conversational speech tasks will be completed on each of the five intervention days. Metronome- timed speech will be practiced during these tasks, at near-normal (comfortable) speech rate for each participant. Each intervention session will be 40 minutes in duration.
15940757|NCT03335722|Device|Active tDCS|1-mA tDCS with the anode (5 x 7 cm) placed over the left frontal cortex and the cathode (5 x 7 cm) placed symmetrically over the right frontal cortex. tDCS will be delivered using a direct current (DC) stimulator in 'study-mode' for 20 minutes. The current is ramped up to 1 mA over the first 15 seconds of stimulation and maintained at this level for remainder of the 20-minute stimulation session.
15940758|NCT03335722|Device|Sham tDCS|Sham stimulation will be delivered using a DC-stimulator in 'study-mode' for 20 minutes. Participants will receive sham stimulation with the anode and cathode electrodes placed over the left and right frontal cortex as in the active arm. For sham stimulation, the current is ramped up over 15 seconds, maintained for 15 seconds at 1 mA and ramped down over 15 seconds at the start of stimulation and is then followed by brief (3ms) pulses every 55 seconds for the remainder of the 20-minute stimulation session.
15940759|NCT03335709|Behavioral|ADL intervention|Overall, an adaptational approach is being applied. The intervention sessions include changes related to the person, the environment and/or the occupation.
15940760|NCT03335683|Drug|Lenidase|drug per os twice day for 7 days, or for 10 days
15941858|NCT03327740|Drug|DTG based ARV regimen without ABC|DTG based ARV regimens that do not contain ABC
15940762|NCT03335657|Other|CBPT|The CBPT program focuses on a patient-oriented cognitive-behavioral self-management approach to improve physical function and reduce pain, through reductions in pain catastrophizing and fear of movement and increases in self-efficacy.
15940763|NCT03335657|Other|Education Treatment|Participants receiving the education control arm are receiving a placebo intervention to control for the attention of the interventionist. They will receive standardized educational material addressing recovery from orthopaedic trauma.
15940764|NCT03335631|Behavioral|Exercise|Moderate intensity mixed-modality exercise 4-5 days per week, with a target of 60 minutes per session.
15940765|NCT03335618|Other|Activity Monitoring and Symptom Coaching|Triggered check-ins by study personnel to keep participants on track to meet fitness goals
15940766|NCT03335618|Other|Passive Activity Monitoring|Passive step tracking without check-ins
15940767|NCT03335579|Combination Product|inhalation or propofol ,epidural or general anesthesia, remifentanil or sufentanil|Different combination of opioids and anesthetics
15940768|NCT03335566|Drug|Sonazoid™|Single Dose of Sonazoid™ 0.12 µL MB/kg as I.V. injection.
15940769|NCT03335566|Drug|SonoVue®|Single Dose of SonoVue® 2.4 mL as I.V. injection.
15940770|NCT03335553|Drug|BMS-986235|Specified dose on specified days
15940771|NCT03335553|Other|Placebo|Specified dose on specified days
15940772|NCT03335540|Biological|Nivolumab|Specified dose on specified day
15940773|NCT03335540|Biological|Relatlimab|Specified dose on specified day
15940774|NCT03335540|Biological|Cabiralizumab|Specified dose on specified day
15940775|NCT03335540|Biological|Ipilimumab|Specified dose on specified day
15940776|NCT03335540|Drug|IDO1 Inhibitor|Specified dose on specified day
15940777|NCT03335540|Radiation|Radiation Therapy|Specified dose on specified day
15940778|NCT03335527|Drug|Dexmedetomidine|Dexmedetomidine is administered as a continuous intravenous infusion at a rate of 0.1-0.2 ug/kg/h (0.025-0.05 ml/kg/h) from study recruitment in the ICU during mechanical ventilation, for no more than 72 hours.
15940779|NCT03335527|Drug|Placebo (normal saline)|Placebo (normal saline) is administered as a continuous intravenous infusion at a rate of 0.025-0.05 ml/kg/h from study recruitment in the ICU during mechanical ventilation, for no more than 72 hours.
15940780|NCT03335514|Diagnostic Test|expression of GALNT4|Blood is obtained into ethylenediaminetetraacetic acid（EDTA） tubes from all subjects via antecubital venepuncture and the total RNA was extracted from blood.Realtime PCR was performed to measure the expression of GALNT4.
15940781|NCT03335501|Device|Insulin pump|The participant's insulin pump will be used to infuse insulin
15940782|NCT03335501|Device|Continuous glucose monitoring system|The Dexcom G4 Platinum will be used to measure glucose levels
15940783|NCT03335501|Other|11-hour intervention with the single-hormone artificial pancreas|"Subjects will be admitted at IRCM at 9:30. An intravenous catheter will be inserted into an arm or a hand vein for blood sampling purposes. A cartridge containing rapid-acting Aspart or faster acting Aspart will be placed in the insulin pump. Closed-loop strategy will start at 10:00 until 21:00. A glucose sensor reading will be entered manually into the computer every 10 minutes. The computer will generate a recommendation for the basal rates of insulin delivery. Pumps' parameters will then be changed manually to implement the computer generated recommendations.
~At 12:00, a lunch meal will be served. An insulin bolus will be given 15 minutes before the meal. At 17:00, a dinner meal will be served. As recommended, an insulin bolus will be given at the time of the meal. Each subject will ingest the same meals during both visits.
~Venous blood samples will be obtained for the measurement of plasma glucose and insulin concentrations. Blood samples will be taken every 20 minutes."
15940784|NCT03335488|Drug|RAVICTI|RAVICTI, Oral Liquid Product 17.5 mL maximum total daily dose
15940785|NCT03335488|Drug|NaPBA|"NaPBA in patients weighing < 20 Kg - 600 mg/Kg, maximum total daily dose
~NaPBA in patients weighing > 20 Kg - 13 g/m2, maximum total daily dose"
15940786|NCT03335475|Behavioral|Physical Activity Lifestyle Intervention|Coaches work with participants on three elements of behaviors change: (1) changing attitudes towards physical activity; (2) increase perceptions of other people's approval of physical activity for the participants; (3) increase perceptions of control over being physically active. These elements will be delivered using a non-judgmental stance accompanied by promoting appropriate goal-setting.
15940787|NCT03335475|Behavioral|Physical Activity Monitoring|A physical activity monitor (Fitbit) will be provided to both groups.
15940788|NCT03335462|Other|Paravertebral injections|Paravertebral injections will be performed in the thoraco-lumbar plexus area under CT guidance
15940789|NCT03335462|Other|CT scan|CT scan will be performed as the needles are kept in their position after injecting the contrast
15940790|NCT03335449|Other|Protective ventilation group|Application of a protective ventilation strategy in order to improve gas exchange and respiratory mechanics during Robotic surgery in deep Trendelenburg position.
15940791|NCT03335436|Drug|Gabapentin|Participants will receive Gabapentin 600 mg by mouth one hour prior to scheduled cesarean delivery and 400 mg by mouth every 8 hours post delivery
15940792|NCT03335436|Drug|Placebo|Participants will receive Placebo with similar appearance to gabapentin by mouth one hour prior to scheduled cesarean delivery and by mouth every 8 hours post delivery
15940793|NCT03335423|Drug|Oral metformin|The study was designed as a randomized, cross-over trial with a washout period of at least 1 week between the phases. Metformin was given both orally and through an intravenous route to be able to determine the absolute bioavailability of metformin. Metformin was given alone and together with codeine to investigate a potential interaction between the drugs. Lactate was measured as a proxy for metformin effect on the intestinal mucosa, both after oral and intravenous metformin
15940794|NCT03335423|Drug|Intravenous metformin|The study was designed as a randomized, cross-over trial with a washout period of at least 1 week between the phases. Metformin was given both orally and through an intravenous route to be able to determine the absolute bioavailability of metformin. Metformin was given alone and together with codeine to investigate a potential interaction between the drugs. Lactate was measured as a proxy for metformin effect on the intestinal mucosa, both after oral and intravenous metformin
15940820|NCT03335241|Drug|Pegylated liposomal doxorubicin|Pegylated liposomal doxorubicin 50mg/m2 iv every 4 weeks
15940795|NCT03335423|Drug|Oral codeine and oral metformin|The study was designed as a randomized, cross-over trial with a washout period of at least 1 week between the phases. Metformin was given both orally and through an intravenous route to be able to determine the absolute bioavailability of metformin. Metformin was given alone and together with codeine to investigate a potential interaction between the drugs. Lactate was measured as a proxy for metformin effect on the intestinal mucosa, both after oral and intravenous metformin
15940796|NCT03335423|Drug|Oral codeine and intravenous metformin|The study was designed as a randomized, cross-over trial with a washout period of at least 1 week between the phases. Metformin was given both orally and through an intravenous route to be able to determine the absolute bioavailability of metformin. Metformin was given alone and together with codeine to investigate a potential interaction between the drugs. Lactate was measured as a proxy for metformin effect on the intestinal mucosa, both after oral and intravenous metformin
15940797|NCT03335410|Other|Non- interventional|Non- interventional
15940798|NCT03335397|Device|M-learning application|Mobile application with interactive contents available for android platform and Apple's operating system.
15940799|NCT03335397|Other|Traditional learning process|Traditional content available in university library.
15940800|NCT03335384|Diagnostic Test|Esophageal Balloon|Small flexible catheter with deflated balloon at distal end to be inserted into the esophagus through the nose
15940801|NCT03335384|Diagnostic Test|Gastric Balloon|Small flexible catheter with deflated balloon at distal end to be inserted into the stomach through the nose
15940802|NCT03335384|Diagnostic Test|Nasal Pressure Transducer|Pressure transducer inserted into nasal plug
15940803|NCT03335371|Drug|TTP399|Phase 1: Participants will receive TTP399 administered orally up to 1200 mg taken once daily for 7 days
15940804|NCT03335371|Drug|TTP399|Phase 2: Participants will receive TTP399 administered orally 800 mg taken once daily for 12 weeks
15940805|NCT03335371|Drug|Placebo Oral Tablet|Phase 2: Participants will receive Placebo oral tablets for 12 weeks
15940806|NCT03335358|Behavioral|Dyadic (couples-based) positive psychology intervention|Self-administered behavioral intervention in which participants complete at least 2 activities alone and 2 together each week for 8 weeks. Positive psychology activities include expressing gratitude, practicing acts of kindness, fostering relationships, working toward a goal, focusing on the positive, spirituality, and savoring.
15940807|NCT03335345|Other|maintaining calorie intake|Maintaining enteral caloric intake at the same rate. No aspiration in the gastric tube.
15940808|NCT03335345|Other|maximum gastric vacuity|stopping enteral feeding at least 6 hours before extubation. Suction in the gastric tube (if its caliber permits) continuously for 6 hours before extubation
15940809|NCT03335332|Behavioral|High intensity exercise|The exercise groups will receive identical exercise prescription for the first two months of the intervention, after which the HIE group will incorporate HIIT in their exercise regimen. The reason for this approach is to include a period of general conditioning and progressively increase intensity prior to submitting volunteers to HIE. This approach considers participant safety as arrhythmias may be uncovered during the first two months of MIE training. It will also improve participant compliance by increasing exercise self-efficacy and confidence prior to commencing HIIT.
15940810|NCT03335332|Behavioral|Moderate intensity exercise|A training program will be developed individually for each subject with the goal of increasing duration and intensity consistent with exercise training principles. Workouts will vary with respect to mode (walk, cycle) and duration (30 - 60 minutes). Each subject will be assigned an exercise physiologist and a heart rate monitor so that each session can be tracked and recorded. The first few exercise training sessions in both exercise groups (MIE and HIE) will supervised at our hospital based fitness centre until the subject is confident to complete the training independently.
15940811|NCT03335319|Other|Periodized Exercise Training Regime|MCT 1st: 20 min on an ergometer; at Anaerobic Threshold (AT) 1 or, if the AT could not be adequately determined, 50-60% of the Heart Rate Reserve (HRR), Borg Rating of Perceived Exertion (RPE) equivalent 9-11. MCT 2nd: 20 minutes; 60-70%HRR, RPE 12-13. HIIT 1st: 4 interval training periods of 2 minutes (AT2 intensity or 80-90%HRR, RPE 15-17) and 4 active pauses of 2 minutes (below AT 1 or 40-50%HRR, RPE 6-9) between interval training periods. HIIT 2nd: same intervals as in 1st HIIT different intensities: high intensity interval above AT2 intensity or > 90%HRR, RPE 17-19 and active pauses at AT 1 or 50-60%HRR, RPE 9-11. Resistance training adaptation: 2 sets of 15-20 repetitions 50% 1RM; Hypertrophy: 2 sets 8-12 repetitions at 60% 1RM; Maximal Strength: 2 sets of 6-8 repetitions at 80% 1RM.
15940812|NCT03335319|Other|Non Periodized Exercise Training Regime|To ensure that total training loads were similar in both groups despite differences in intensity, it will be used the training impulses (TRIMP) method from Edwards for the aerobic component and the volume load method for the RT component. All sessions will include 10 minutes of warm up and cool down standardized for both groups. By design, the non periodized group involves an identical total training volume and time commitment but differed regarding metabolic stress induced by the linear periodized group. All patients will be monitored with a HR monitor during the execution of the exercise session in order to achieve the HR training. Blood pressure will be assessed before and after completing each session. If necessary, the blood pressure will be measured during the ET session.
15940813|NCT03335293|Drug|100 mcg Epinephrine|This study will evaluate the optimal dose of epinephrine as an adjunct to spinal doses of 1.6 mL hyperbaric bupivacaine + 20 mcg preservative free fentanyl + 150 mcg preservative-free morphine.
15940814|NCT03335293|Other|normal saline|placebo comparator
15940815|NCT03335293|Drug|200 mcg Epinephrine|This study will evaluate the optimal dose of epinephrine as an adjunct to spinal doses of 1.6 mL hyperbaric bupivacaine + 20 mcg preservative free fentanyl + 150 mcg preservative-free morphine.
15940816|NCT03335280|Drug|68Ga-citrate PET/MR|Study participants will undergo the 68Ga-citrate PET/MR imaging after all screening and baseline assessments have been completed. Patient shall begin imaging between 120 and 360 minutes after the injection of the radiopharmaceutical. Coverage for the scan will extend from the patient's vertex to the neck. The entire imaging study will take roughly 90 minutes.
15940817|NCT03335267|Drug|CPX-351|Cytarabine:Daunorubicin Liposome Injection
15940818|NCT03335254|Drug|TSX-011|TSX-011 are capsules with Testosterone Undecanoate (prodrug for androgen testosterone) as the primary ingredient.
15940819|NCT03335241|Drug|Fludarabine and Pegylated liposomal doxorubicin|"Fludarabine 25mg/m2 iv on days d1-d3 of each 4-week cycle
~Pegylated liposomal doxorubicin 30mg/m2 iv every 4 weeks"
15940822|NCT03335215|Other|cognitive remediation|The innovative nature of this program is that it integrates both neuropsychological psychoeducation, the principles of reeducation of altered cognitive functions and the setting in addictological context benefiting from the interactions of the group situation. Thus, during the three months of REMED management, six modules corresponding to six altered cognitive domains that may have an impact on the maintenance of the therapeutic contract will be offered to patients. The REMED group will benefit from cognitive remediation of episodic memory disorders, executive and attentional functions, and the theory of the mind integrating psychoeducation, training and systematic situations related to an alcoholic context. The different procedures of neuropsychological management (facilitation, use of preserved capacities and compensation) will help to integrate the concepts and addictological strategies necessary to maintain the therapeutic contract taking into account cognitive impairments.
15940823|NCT03335202|Diagnostic Test|analysis of microbiome|microbial profiling by next generation sequencing
15940824|NCT03335189|Device|ASyMS-Can|Data reported by the participants will be sent to a secure, encrypted clinical central server hosting the risk-alerting algorithms. The web interfaces will provide a clinical portal for the nurses to screen and follow any alerts being triggered, as well as review patient-specific information. Based on these back-end computations, participants will receive automated self-care notifications on their mobile phones. If incoming symptom reports indicate severe adverse effects a designated clinic nurse will receive an 'amber alert', or 'red alert', that will require response within 30 minutes. Nurses will handle alerts during business hours (9 am to 5 pm). After-hour alerts will be sent to the oncologist or nursing supervisor on call as per usual care. Patients will be instructed that clinicians will not receive alerts during the evening hours or night and instructed to follow usual practice of contacting their family physician, or oncologist on call, or call 911, as required.
15940825|NCT03335176|Behavioral|Endurance ad Resistance Training Exercise|Patients received a 6-week tele-supervised rehabilitation with 3 exercise sessions per week
15940826|NCT03335163|Drug|Topiramate|"Topiramate - Participants will undergo a 6 week titrated regimen of oral topiramate to reach a maximum dose of 400mg per day:
~Week 1 - topiramate PO 25mg daily Week 2 - topiramate PO 25mg twice daily Week 3 - topiramate PO 50mg twice daily Week 4 - topiramate PO 100mg twice daily Week 5 - topiramate PO 150mg twice daily Week 6 - topiramate PO 200mg twice daily"
15940827|NCT03335150|Behavioral|CogSMART-PD|Cognitive Rehabilitation for persons with PD-MCI
15940828|NCT03335150|Behavioral|Supportive Care|Support Group for persons with PD-MCI
15940829|NCT03335137|Diagnostic Test|Drug Level Monitoring|Free (unbound) drug concentration 1 hour, 4 hours and 7.5 hours after primary load of piperacillin/tazobactam on day 1 and day 3 after admission
15940830|NCT03335124|Drug|Vitamin C|Vitamin C: Vitamin C will be applied as per instructions described in arm/group descriptions.
15940831|NCT03335124|Drug|Hydrocortisone|Hydrocortisone: Hydrocortisone will be applied as per instructions described in arm/group descriptions.
15940832|NCT03335124|Drug|Thiamine|Intravenous thiamine will be applied as per instructions described in arm/group descriptions.
15940833|NCT03335124|Drug|0.9% Sodium Chloride Injection|0.9 % Sodium Chloride will be applied as placebo as per instructions described in arm/group descriptions.
15940834|NCT03335111|Other|Remote Ischemic Conditioning Equipment|BAIPC is admistrated by 5 cycles extremities ischemia (5-minute blood-pressure cuff inflation up to 50 mmHg higher than baseline, followed by 5-minute cuff deflation) for one week.
15940835|NCT03335111|Procedure|Intravenous blood collection|Nurses will collect 5 ml intravenous blood with anticoagulant and 5ml total blood at 0d, 1d and 7-10d respectively. The blood samples will be stored for laboratory assay. The blood samples only use in this trial.
15940836|NCT03335098|Drug|Bortezomib|Six 4-week cycles
15940837|NCT03335085|Drug|Oxytocin|
15940838|NCT03335085|Other|Placebo|
15940839|NCT03335072|Drug|Azithromycin|Mass Drug Administration
15940840|NCT03335059|Combination Product|Synergo® RITE + MMC|Subjects will receive a series of induction followed by a series of maintenance bladder instillations of Synergo® RITE + MMC
15940841|NCT03335046|Behavioral|Home Visit|The intervention will consist of a series of home visitations to chronically absent students with co-morbid asthma. These visits will consist of a home environment evaluation, medication adherence and knowledge assessment, distribution of home environmental allergen reduction items such as mattress and pillow encasements, as well as review and reinforcement of any asthma action plans or care plans provided by patient's primary care physicians or medical home.
15940842|NCT03335046|Behavioral|Standard Care|Standard care will refer to the procedures carried out by the school district to address students with chronic absenteeism. This includes parent-teacher and parent-school administrator meetings and communications and may also include home visits carried out by classroom teachers or student support center staff.
15940843|NCT03335033|Combination Product|Contrast-enhanced ultrasound|Subjects will receive a low mechanical index (0.17-0.20) imaging during ultrasound contrast agent intravenous infusion. Real-time cine-loop including longitudinal and transverse images obtained at least 3 seconds before and 5 minutes after the appearance of the contrast effect in the lumen of the carotid artery will be acquired and digitally stored for offline analysis. Also use of a 3D ultrasound transducer to evaluate the feasibility of using US images with contrast to assess the residual diameter of the diseased vessel. Specifically, two 3D acquisitions of each lesion would be obtained after contrast has been injected.
15940844|NCT03335033|Device|Shear Wave Elastography|Shear wave elastography will be performed with the General Electric Logiq E9 scanner acquiring images of each plaque in the longitudinal and transverse imaging planes. In each plane 10 measurements will be made and the in-phase/quadrature (IQ) data will be saved for further analysis. The plaque area in the imaging plane will be user-defined to extract the wave velocity values for a ROI analysis.
15940845|NCT03335033|Device|Ultrasound Examination|A standard carotid US examination using Duplex imaging will performed using a linear array transducer to obtain longitudinal and transverse images. All ultrasound measurements will be made by a trained registered vascular technologist. Severity of stenosis of the plaque will be measured based on established protocol and guidelines.
15940870|NCT03334799|Device|sacroiliac belt|standing and walking with the belt on and with the belt off
15940871|NCT03334786|Drug|FLX-787-ODT|Oral Disintegrating Tablet
15940872|NCT03334773|Behavioral|Nutrition education|
15940910|NCT03334565|Device|High efficiency air filtration systems|Subjects were exposed to high-efficiency filtered air.
15940846|NCT03335020|Device|Shear Wave Elastography|The subject will be asked to lay on a hospital bed for ultrasound imaging of the arteries. The subject will have an automatic blood pressure cuff put on to measure blood pressure. The subject will also have a three-lead ECG taken during the experiment. The artery will be visualized using ultrasound imaging, and the depth of the arterial wall will be noted. The focal depth on the device will be set to measure shear wave propagation in the walls of the artery. Measurements will be made at multiple locations along the artery's length and at different phases of the cardiac cycle determined by ECG gating. Either or both the Verasonics or GE Logiq systems will be used for measurements. Measurements made with these systems use acoustic output within the FDA regulatory limits of diagnostic imaging.
15940847|NCT03335020|Device|Pulse Wave Imaging|Researchers will use the Verasonics device to acquire data for measurement of wave velocity in the tissue of interest (arterial walls and surrounding tissue) due to the pressure pulse from ejection of blood by the heart into the systemic circulation. Using ECG gating we can regulate the timing of the individual acquisitions. In each acquisition, high frame rate ultrasound imaging is used to acquire data to measure the motion of the propagating waves. Multiple measurements on different heartbeats are made with varying delays to obtain measurements throughout the heart cycle assuming at that the behavior during consecutive heartbeats is similar. Multiple measurements will be made in a given artery and multiple locations in the arterial wall.
15940848|NCT03335020|Drug|Contrast-Enhanced Ultrasound|Will be done using Lumason (Bracco Diagnostics, Inc) administered intravenously via slow hand infusion. Real-time contrast-enhanced carotid cine-loop (longitudinal and short axis) images obtained at least 3 seconds before and 5 minutes after the appearance of the contrast effect in the lumen of the determined artery will be acquired and digitally stored for off line analysis. Up to two vials will be used for a study.
15940849|NCT03335020|Other|Strain Imaging|Measurements will be performed offline on the workstation using Echo PAC software (GE Healthcare Inc., Princeton, NJ). The media-adventitia interface of the arterial wall will be manually traced from a still frame image. The circumferential and radial strain curves will be automatically obtained. Measurements of the peak radial and circumferential strain, strain rate will be obtained. If arterial plaque is identified: A region of interest will be placed at the plaque in 3 different regions: 2 shoulder regions and the fibrous cap top, the measurement results of the peak longitudinal, radial and circumferential strain, strain rate will be acquired by the software.
15940850|NCT03335020|Device|3-D Volume Ultrasound|When generating a 3D volume the ultrasound data can be collected in 4 common ways. Freehand, which involves tilting the probe and capturing a series of ultrasound images and recording the transducer orientation for each slice. Mechanically, where the internal linear probe tilt is handled by a motor inside the probe. Using an endoprobe, which generates the volume by inserting a probe and then removing the transducer in a controlled manner. The fourth technology is the matrix array transducer that uses beam steering to sample points throughout a pyramid shaped volume
15940851|NCT03335007|Drug|Aceclofenac|Aceclofenac 100 mg tablet given one hour before starting the root canal treatment
15940852|NCT03335007|Other|Placebo|Placebo tablet given one hour before starting the root canal treatment
15940853|NCT03334994|Procedure|Intervention group:(Group B) connective tissue graft combined with immediate implant.|Patients will be treated with connective tissue graft combined with immediate implant.
15940854|NCT03334981|Procedure|Concentrations in Meconium of Buprenorphine and Methadone|buprenorphine or methadone concentration measurement
15940855|NCT03334955|Procedure|Laparoscopic ovarian drilling|A specially designed monopolar electrocautery probe was used to penetrate the ovarian capsule at 4 points, with the aid of a short burst of monopolar diathermy. The probe (which has a distal stainless steel needle measuring 10 mm in length and 2 mm in diameter) was applied to the surface of the ovary at a right angle to avoid slippage and to minimize surface damage. A monopolar coagulating current at a 40 W power setting was used. The needle was pushed through the ovarian capsule for about 4 mm depth into the ovarian tissue and electricity was activated for 4 seconds.
15940856|NCT03334942|Behavioral|Child and Family Traumatic Stress Intervention|The Child and Family Traumatic Stress Intervention (CFTSI) is a 5-8 session intervention, initiated within 60 days of trauma exposure for youth reporting acute PTSS. CFTSI is designed for children age 7 and older, and requires the involvement of a caregiver who knows the child well enough to report changes in the child's behavior and symptoms. CFTSI targets modifiable risk and protective factors during the early post-trauma period to promote recovery and reduce PTSS via caregiver-child communication and cognitive and emotional processing. CFTSI uses skill modules (e.g., sleep disturbance, intrusive thoughts, anxiety) to teach effective strategies to decrease a child's PTSS. Coping and communication skills are taught and practiced in caregiver-child sessions and in the home.
15940857|NCT03334929|Device|Virtual Reality headset|The participants in this group would wear Virtual Reality headset called Oculus Gear VR during their trigger point injections.
15940858|NCT03334916|Drug|YMC026|YMC026 20mL TID
15940859|NCT03334916|Drug|Placebo|Placebo 20mL TID
15940860|NCT03334903|Drug|Gabapentin|600 mg gabapentin before and after surgery. 300 mg gabapentin for approx. 5 weeks after surgery.
15940861|NCT03334890|Diagnostic Test|plasma mSEPT9 level|the plasma level of methylated SEPT9
15940862|NCT03334877|Diagnostic Test|β -human chorionic gonadotropin|Cervico vaginal fluid sampling was undertaken for qualitative assessment of β -human chorionic gonadotropin (β-hCG) and fetal fibronectin(fFN) at 24 weeks of gestation.
15940863|NCT03334851|Drug|PF-06835375|Intravenous (IV) or subcutaneous (SC) administration. Subjects will receive one or two doses. Doses will be ascending and determined by emerging data.
15940864|NCT03334851|Drug|Placebo|Matching placebo for PF-06835375 IV or SC. Subjects will receive one or two doses.
15940865|NCT03334838|Drug|Nifurtimox (Lampit, BAYA2502)|Oral Intake of 4 x 30 mg nufurtimox tablets for treatment A-D; Oral Intake of 8 x 30 mg nufurtimox tablets for treatment E.
15940866|NCT03334825|Other|Enhanced housing placement assistance|assistance in the rapid (fast-track) acquisition of permanent housing; and participation in a 12-month support services program designed to prevent PLWHA from relapsing into homelessness, with services focused on increasing clients' capacity to live independently and maintain housing stability
15940867|NCT03334825|Other|Standard housing placement assistance|standard connections to services and housing programs offered by HASA, HOPWA, or Ryan White
15940868|NCT03334812|Biological|LNA043|LNA043 Single dose
15940869|NCT03334812|Biological|placebo to LNA043|placebo to LNA043 single dose
15940873|NCT03334760|Other|Danish National Birth Cohort|DNBC is a nationwide cohort study of pregnant women and their offspring. The women were enrolled early during pregnancy between 1996 and 2002. They provided information on exposures during and after pregnancy by means of four computer-assisted telephone interviews in gestational weeks 12 and 30 and post-partum when the child was 6 and 18 months old.
15940874|NCT03334747|Drug|KAE609|Exploration of different doses of KAE609 to establish safety profile.
15940875|NCT03334747|Drug|Coartem|Control Arm
15940876|NCT03334734|Drug|PBTZ169|Once a day for 14 days
15940877|NCT03334734|Drug|Isoniazid|Once a day for 14 days
15940878|NCT03334721|Drug|Gabapentin|5 day trial of gabapentin with titration to 1,200mg
15940879|NCT03334721|Drug|Placebo Oral Capsule|5 day trial of matched placebo
15940880|NCT03334708|Diagnostic Test|Blood Draw|"If clinically safe, up to approximately 50ml of blood will be drawn, not to exceed the following criteria:
~Patients and controls weighing 50kg or more
~For draw amounts up to 50mL, there is no required hemoglobin threshold.
~For amounts exceeding 50mL, patients who meet standard blood banking criteria (e.g., hemoglobin values within normal limits and minimum weight of 50kg) may give as much as a full unit of blood (500mL) at one time or in divided fractions over a 56 day/eight week period.
~Patients and controls weighing < 50kg
~For patients whose hemoglobin is below normal limits but at least 7.0 gm/dL, no more than a total of 50 ml of blood or 5 ml/kg, whichever is less, may be collected per 56 day/eight week period, but no more than approximately 2 ml/kg of blood at any one time."
15940881|NCT03334708|Diagnostic Test|Tumor Tissue Collection|Tumor tissue will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere
15940882|NCT03334708|Diagnostic Test|Cyst Fluid|Cyst fluid will be obtained by already planned biopsy, either at Memorial Sloan Kettering Cancer Center or elsewhere
15940883|NCT03334695|Biological|Ad26.RSV.preF|Ad26.RSV.preF will be administered as intramuscular injection at a dose of 1*10^11 vp in single-use vials.
15940884|NCT03334695|Drug|Placebo|Placebo will be administered as sterile 0.9% saline for injection.
15940885|NCT03334682|Drug|spironolactone|Dispensation of spironolactone at each visit according to the arm description described above.
15940886|NCT03334682|Drug|Doxycycline|Dispensation of doxycycline then placebo, at each visit according to the arm description described above.
15940887|NCT03334669|Behavioral|Parents Connect for Healthy Living (PConnect)|Parents Connect for Healthy Living (PConnect) parent curriculum: This 10-week program (20 hours total) engages Head Start parents in a wide range of topics related to health and empowerment and is designed to foster a safe, open forum through which parents can connect with other parents and mobilize resources to support their family's health; NOTE: The PConnect program was not implemented in 2019-2020 due to the coronavirus pandemic. In 2020-2021, PConnect was implemented virtually; these are pilot data and not part of the main trial.
15940888|NCT03334669|Behavioral|Enhanced Nutrition Support|Enhanced Nutrition Support: Existing nutrition resources within Head Start (e.g., Biannual child health letters) are expanded and improved to ensure parents are aware of their child's weight status and are linked with age-appropriate weight management services if their child has overweight or obesity. NOTE: Enhanced nutrition support was not implemented in spring 2020 due to the pandemic. In 2020-2021, it was moved to a virtual format in what will be a pilot virtual trial.
15940889|NCT03334669|Behavioral|Media Resources|Media Resources: Print and online resources that employ consistent messaging to reach parents and ensure that behavior change messages are accessible to families. NOTE: Due to the pandemic, media resources were not shared in spring 2020. They were implemented in virtual format in 2020-2021 in a pilot virtual trial.
15940890|NCT03334656|Biological|biological dressing|to test a biological dressing on the wound healing of the split-thickness skin graft donor site
15940891|NCT03334656|Other|Paraffin gauze dressing|standard intervention : Paraffin gauze dressing on the wound healing
15940892|NCT03334643|Dietary Supplement|Fiber mix|Participants will test white bread or fiber mix over a span of 2 weeks. During each testing block, each food will be tested twice over two consecutive days. There are 4 testing blocks in total (one for white bread and three for fiber mix).
15940893|NCT03334630|Device|DiamondTemp Ablation catheter|a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
15940894|NCT03334630|Device|TactiCath Quartz Ablation catheter|a pulmonary vein isolation procedure will be performed using radiofrequency ablation catheter
15940895|NCT03334617|Drug|Durvalumab|Durvalumab given IV at 1500 mg Q4W ±2 days
15940896|NCT03334617|Drug|AZD9150|AZD9150 given IV at 200mg every other day of a 1-week lead-in period followed by QW
15940897|NCT03334617|Drug|AZD6738|AZD6738 given orally at 240mg twice daily in Cycle 0 Days 1-7, followed by 7 days on treatment in each cycle between Days 22-28
15940898|NCT03334617|Drug|Vistusertib|Vistusertib (AZD2014) given orally at a dose of 125 mg BD on an intermittent dosing schedule of 2 days on, 5 days off
15940899|NCT03334617|Drug|Olaparib|Olaparib (AZD2281) given orally at 300 mg BD
15940900|NCT03334617|Drug|Oleclumab|Oleclumab given at dose level 1 for 2 cycles and then dose level 2 thereafter
15940901|NCT03334617|Drug|trastuzumab deruxtecan|Durvalumab given IV at 1120mg Q3W ±2 days for Module 6 only & trastuzumab deruxtecan given at 5.4 mg/kg via IV infusion Q3W ±2 days
15940902|NCT03334617|Drug|cediranib|cediranib given orally at 20 mg tablets on an intermittent schedule (5 days on, 2 days off), starting on C1D1
15940903|NCT03334617|Drug|AZD6738 (ceralasertib)|AZD6738 given at 240 mg twice daily for 14 days on treatment in each 28-day cycle, between Days 1 and 14.
15940904|NCT03334617|Drug|AZD6738 (ceralasertib)|AZD6738 given orally at 240mg twice daily for 14 days in each 28 day cycle (starting from Cycle 1) between Days 15-28
15940905|NCT03334604|Dietary Supplement|Multispecies probiotic|Multispecies probiotic consisting of Bifidobacterium bifidum W23, Bifidobacterium lactis W51, Lactobacillus acidophilus W37, Lactobacillus acidophilus W55, Lactobacillus paracasei W20, Lactobacillus plantarum W62, Lactobacillus rhamnosus W71 and Lactobacillus salivarius W24 at a dose of 5x10^9 Colony Forming Units (CFU), twice daily, orally.
15940906|NCT03334604|Other|Placebo|Placebo identical in taste, smell and color to the multispecies probiotic.
15940907|NCT03334591|Drug|Apatinib|Apatinib 500mg with Docetaxel 60mg/m2
15940908|NCT03334578|Drug|Gastrografin|Gastrografin group
15940909|NCT03334565|Device|Low efficiency air filtration systems|Subjects were exposed to low-efficiency filtered air.
15940911|NCT03334565|Device|Air filtration systems without filters (sham)|Subjects were exposed to unfiltered air.
15940912|NCT03334539|Biological|HL036 ophthalmic solution|HL036 ophthalmic solution
15940913|NCT03334539|Other|Placebo vehicle solution|Placebo vehicle solution
15940914|NCT03334526|Other|physical training|workout on treadmill requiring the muscles of the lower limbs mostly in concentric (ascent) or eccentric (downhill)
15940915|NCT03334526|Other|mental training|The task to imagine for the training group will be an abduction of the thumb
15940916|NCT03334526|Other|electrical stimulation|electrical stimulation of the muscles
15940917|NCT03334513|Drug|Bevacizumab|intravitreal injection of bevacizumab
15940918|NCT03334513|Drug|Ranibizumab|intravitreal injection of ranibizumab
15940919|NCT03334500|Device|[18F]FluorThanatrace|Fluorine-18 labeled FluorThanatrace [18F]FTT can be synthesized with high specific activity so the quantity of mass injected with the radiopharmaceutical is < 10 μg.
15940920|NCT03334500|Drug|Poly(ADP Ribose) Polymerase 1|Poly(ADP-ribose) polymerase (PARP) is a family of enzymes involved in base excision repair (the repair of DNA single-strand breaks) and alternative end joining (repair of DNA double-strand breaks). The molecular basis of PARP1 inhibitor function may depend on the dual roles of PARP1 as a modulator of gene transcription in addition to DNA damage repair 3.
15940921|NCT03334487|Drug|Dexamethasone|Oral
15940922|NCT03334487|Drug|Rovalpituzumab tesirine|Intravenous
15940923|NCT03334461|Combination Product|Exposure to oral antiseptics or enamel remineralisation agent|
15940924|NCT03334448|Drug|LY900014-U200|Administered SC
15940925|NCT03334448|Drug|LY900014-U100|Administered SC
15940926|NCT03334435|Drug|Baricitinib|Administered orally
15940927|NCT03334435|Drug|Placebo|Administered orally
15940928|NCT03334422|Drug|Baricitinib|Administered orally
15940929|NCT03334422|Drug|Placebo|Administered orally
15940930|NCT03334409|Drug|Ascorbic Acid|Given IV
15940931|NCT03334409|Drug|Pazopanib Hydrochloride|Given PO
15940932|NCT03334396|Drug|Baricitinib|Administered orally.
15940933|NCT03334396|Drug|Placebo|Administered orally.
15940934|NCT03334383|Device|Sponge|Compressed cellulose sponge for use in laparoscopic surgery to retract the intestines from the surgical field.
15940935|NCT03334357|Other|PAR|
15940936|NCT03334357|Other|HIIT|
15940937|NCT03334357|Other|WB-EMS|
15940938|NCT03334344|Device|Ceevra Reveal|VR models generated using Ceevra Reveal are viewed by surgeons in connection with the case in addition to source CT/MR image.
15940939|NCT03334331|Other|Six-minute step test|Volunteers will be instructed to go up and down one step for six minutes
15940940|NCT03334331|Other|Six-minute walk test|Volunteers will walk the longest distance possible by performing turns in a 30 meter corridor for six minutes
15940941|NCT03334318|Other|Mean blood glucose|Mean of blood glucose values measures by continuous glucose monitoring from week 80 to week 164 of the PERL trial.
15940942|NCT03334318|Other|Blood glucose CV|Coefficient of variation of blood glucose values measures by continuous glucose monitoring from week 80 to week 164 of the PERL trial.
15940943|NCT03334318|Other|% time 70-180 mg/dL|Percent of time with blood glucose in the 70-180 mg/dL range as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.
15940944|NCT03334318|Other|% time below 54 mg/dL|Percent of time with blood glucose below 54 mg/dL as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.
15940945|NCT03334318|Other|% time above 180 mg/dL|Percent of time with blood glucose above 180 mg/dL as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.
15940946|NCT03334318|Other|% time above 250 mg/dL|Percent of time with blood glucose above 250 mg/dL as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.
15940947|NCT03334318|Other|MAGE (Mean amplitude of glucose excursions)|Mean amplitude of glucose excursions as measured by continuous glucose monitoring as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.
15940948|NCT03334318|Other|LBGI (Low Blood Glucose Index)|Low blood glucose index as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.
15940949|NCT03334318|Other|HBGI (High Blood Glucose Index)|High blood glucose index as measured by continuous glucose monitoring from week 80 to week 164 of the PERL trial.
15940950|NCT03334318|Drug|Allopurinol|Oral allopurinol tablets administered in the PERL Clinical Trial
15940951|NCT03334318|Drug|Placebo|Oral placebo tablets administered in the PERL Clinical Trial
15940952|NCT03334305|Biological|TTRNA-DC vaccines with GM-CSF|After chemoradiation subjects will receive the first cycle of dose-intensified TMZ followed by three biweekly TTRNA-DC vaccines with GM-CSF. Monthly DC vaccines will be given during TMZ Cycles 2-5 for Groups A and B and 48-96 hours after completion of TMZ Cycle 6 Day 21 for Group A and 12-36 hours after HSCs for Group B. All subjects will receive an additional two bi-weekly vaccines during Cycle 6 for a total of 10 DC vaccines. All DC vaccines will be embedded with GM-CSF (150 µg per injection) and given intradermal.
15940953|NCT03334305|Drug|Dose-intensified TMZ|After chemoradiation, subjects will receive the first cycle of dose-intensified TMZ followed by three biweekly TTRNA-DC vaccines with GM-CSF. All subjects will have an additional five cycles of dose-intensified TMZ (for a total of 6 Cycles) with concurrent monthly DC vaccinations.
15940954|NCT03334305|Biological|Autologous Hematopoietic Stem cells (HSCs)|Prior to chemoradiation, enrolled subjects will undergo a mobilized leukapheresis for collection of PBSCs and PBMCs for generation of DCs. One group will receive recommended dose of > 2 x 106 CD34+ HSCs/kg. Subjects enrolled in Group B will receive HSCs during TMZ Cycle 6 before receiving DC vaccine and T-cell infusion.
15940955|NCT03334305|Biological|TTRNA-xALT|During TMZ Cycle 6 and with DC vaccine #8, an infusion of T-cells will be administered to all subjects.
15940956|NCT03334305|Drug|Td vaccine|A full Td booster vaccine will be administered IM at Vaccine #1 to all subjects, and vaccine site pretreatment will be administered to all subjects prior to Vaccine#3, #6, and #8.
15940957|NCT03334279|Other|Cigarette smokers|frequent cigarette smoking for not less than 5 years
15940958|NCT03334279|Other|Simultaneous cigarette and cannabis smokers|frequent cigarette and cannabis smoking for not less than 5 years
15940983|NCT03334084|Drug|ARGX-113|intravenous or subcutaneous administration
15940959|NCT03334266|Behavioral|Family Spirit Nurture (FSN)|The FSN home-visiting module consists of 36 60-minute lessons delivered by trained local FHCs, from 28 weeks gestation to 18 months postpartum. The lessons focus on three key content domains: 1) promotion of optimal breastfeeding, complementary and responsive feeding across early childhood; 2) promotion of healthy infant/toddler diet and physical activity, as well as reduced screen time and sedentary lifestyle; and 3) promotion of maternal psychosocial well-being, optimization of healthy food/beverage availability and identification/creation of safe play spaces in the home environment.
15940960|NCT03334266|Other|Injury Prevention Education (IPE)|The control group will receive Injury Prevention Education (IPE). The IPE home-visiting module consists of 8 30-minute lessons delivered by trained local Family Health Liaisons (FHL), from 28 weeks gestation to 18 months postpartum. Injury prevention lessons focus on injury prevention topics relevant to the participating communities, including: motor vehicle safety for mothers and children; preventing scald burns; fire safety; child-proofing a home; preventing falls; preventing poisonings; and preventing animal bites.
15940961|NCT03334266|Other|Optimized Standard Care (OSC)|OSC will be available to both in the FSN intervention and control groups. OSC consists of transportation assistance to prenatal and well-baby clinic visits as recommended by the Indian Health Service (IHS) and American Academy of Pediatrics (AAP) and rescue services through linkages to community agencies as needed.
15940964|NCT03334240|Drug|CLS003|CLS003
15940965|NCT03334240|Drug|Vehicle|Vehicle
15940966|NCT03334227|Device|High-Flow nasal cannula (HFNC)|The patient will receive HFNC adjusted for SatO2 > 92% and with, at least, 30 liters of total flow.
15940967|NCT03334214|Drug|IONIS DGAT2Rx|Single Dose of DGAT2Rx administered subcutaneously once weekly for 13 weeks
15940968|NCT03334214|Drug|Placebo|Saline 0.9%
15940971|NCT03334188|Behavioral|Patient engagement materials|The intervention is a brief, animated video designed to engage and activate patients around their HFrEF medication prescribing, as well as a HFrEF medication checklist.
15940972|NCT03334188|Behavioral|No Intervention--Usual Care|Control for intervention--patient receives care as usual from provider to contrast against intervention arm.
15940973|NCT03334175|Drug|Walnuts|1 ounce of individually wrapped, raw walnuts to be consumed daily replacing a high-refined carbohydrate food.
15940974|NCT03334162|Behavioral|Sensorimotor training|"Supervised training sessions will last for about 20 to 30 minutes in total, including a child-specific warm-up and cool-down. The children will be asked to maintain balance in a previously acquired short-foot-position, knees slightly flexed (30°), without shoes. Training will consist of 5 playful balance exercises, chosen from a standardized pool of exercises according to the child's age, with increasing difficulty (5 degrees of difficulty - e.g. by reducing the base of support, or dual task exercises - per exercise depending on the age group) in order to allow for individual, optimal progression. Each of the 5 exercises will contain of 5 repetitions for 10sec. allowing for a 20sec. rest in between each set and a 1min rest between each exercise in order to avoid neural fatigue. Children will be given a training manual and diary to train at home after the study. Guardians will be instructed in order to be able to assist their children"
15940975|NCT03334149|Other|Self-Monitoring of Blood Pressure|"BUMP 1: Women randomised to the self-monitoring arm will be asked to measure blood pressures at least three times a week. They will perform two readings with a one minute interval and will be asked to act on the second reading if it falls outside their normal range thresholds described in their instructions, and aided by the tele monitoring system.
~BUMP 2: Women randomised to the self-monitoring arm will be asked to measure blood pressures daily. They will perform two readings with a one minute interval and will be asked to act on the second reading if it falls outside their normal range thresholds described in their instructions, aided by a tele monitoring system."
15940976|NCT03334136|Drug|25-Hydroxyvitamin D|Capsules containing 20 000 IU 25-hydroxyvitamin D given orally: five capsules the first day and thereafter one capsule every week for 4 months (average daily dose approximately 3.000 IU)
15940977|NCT03334136|Drug|Placebo oral capsule|Five capsules the first day and thereafter one capsule every week for 4 months.
15940978|NCT03334123|Other|Functional training and cycling|"First 8 weeks: patients will perform 20 minutes of functional training before their dialysis procedure. The exercise program will be run by kinesiologists, who will also teach patients how to perform exercises on their own at home. During intradialysis cycling 3 times weekly participants will cycle on adapted ergometer. Participants will start with 10 - 15 minutes of cycling and then gradually increase time and intensity up to 45 minutes of duration.
~Second phase of 8 weeks: participants will no longer perform functional training before dialysis but will be motivated, monitored and advised to perform functional exercise at home on non-dialysis days for 20-30 minutes and continue with cycling sessions during the dialysis procedures three times weekly."
15940979|NCT03334123|Other|Cycling|"First 8 weeks: cycling on an adapted ergometer during dialysis; starting with 10 - 15 minutes of cycling and then gradually increasing time and intensity up to 45 minutes of duration.
~Second 8 weeks: continue with cycling at the target duration and intensity during dialysis."
15940980|NCT03334110|Procedure|A method of operation: LIMA-GSV-SCVBG|On the experimental group,We treat patients with the operation of LIMA-GSV composited Y graft and anastomose the GSV with selective coronary vein
15940981|NCT03334110|Procedure|BIMA-SCVBG|On the other group, We treat patients with the operation of bilateral internal mammary artery composited LIMA-Right Mammary Artery（RIMA） y graft and anastomose the Right Mammary Artery(RIMA) with selective coronary vein.
15940982|NCT03334097|Other|Prenatal education|"Education intervention will consist of a total of six sessions one week apart, with two hours of duration each one. The sessions that are exclusively oriented towards preparation for childbirth are session 1 and session 2. The content of each session is:
~St. Birth: Start of childbirth, Symptoms and Signs, Delivery schedules, Phases of childbirth, Normal childbirth, Other circumstances (Obstetrical pathology / previous pathology, Induction of labor, Instrumental birth, Caesarean section).
~nd:methods for relieving birth pain: Alternative Methods of Pain Relief, Pharmacological analgesia, Regional analgesia. Local and regional anesthesia, General anesthesia, breathing training and accompaniment during childbirth-
~rd: Puerperium.
~rd :Breastfeeding
~rd : Newborn care
~rd :Positive parenting."
15940984|NCT03334071|Behavioral|Exercise|"High intensity interspersed with short periods of exercise at a moderate intensity (aerobic interval training). We will also include resistance training in each session.
~The supervised in-hospital exercise training sessions will last <1 hour, exercise training intensities will be individually tailored to each CPET. Exercise training will involve repeated exercise bouts of 3 minutes at a moderate exercise intensity (80%AT) followed by 2 minutes of exercise at a high intensity (50%Δ) for a predetermined amount of time.
~The home-based training programme will involve stair climbing (where possible) and brisk walking to achieve heart rates commensurate with those achieved during the in-hospital exercise training sessions."
15940985|NCT03334058|Drug|ARGX-113|human IgG1-derived Fc fragment that binds to human neonatal Fc receptor (FcRn)
15940986|NCT03334045|Radiation|PET/MR scans|Observations of glucose metabolism and dopamine binding potential
15940987|NCT03334032|Other|Inpatient treatment for Anorexia nervosa|Nutritional rehabilitation in a clinic with specialized eating disorder service
15940988|NCT03334019|Other|blood test|Data collected on general population, farmers and veterinarians though questionnaires and blood samples.
15940989|NCT03334006|Drug|Pentaglobin®|Standard of Care + Pentaglobin®
15940990|NCT03333993|Other|Pilates Exercise|The Mat Pilates exercise will be performed twice a week and the duration of the sessions will be 60 minutes, consisting of 5 minutes of warm-up exercises, 50 minutes of strengthening exercises followed by 5 minutes of relaxation and stretching.
15940991|NCT03333993|Other|Home exercises|Exercises for upper limbs according to the institutional routine.
15940992|NCT03333954|Device|PRIMA|"The PRIMA Bionic Vision System is a device for treatment of patients who have lost their sight through outer retinal degenerative conditions of the eye such as atrophic dry age related macular degeneration.
~The PRIMA System is designed to provide partial restoration of the patient's visual function through electrical stimulation of the retinal neurons by a sub-retinally implanted stimulator that replace part of the degenerate photoreceptors"
15940993|NCT03333941|Device|ReCell® Autologous Cell Harvesting Device|RES (Regenerative Epithelial Suspension) derived from the use of the ReCell® device will be applied over skin grafts meshed more widely than conventional autografting.
15940994|NCT03333928|Drug|HTD1801|HTD1801 tablets, 250mg
15940995|NCT03333928|Drug|Placebo|tablets manufactured to mimic HTD1801 tablets
15940996|NCT03333915|Drug|Pamiparib|Pamiparib is provided as oral capsules，Three dose levels will be evaluated as 20mg, 40mg, 60mg separately， twice a day in phase I and will be used with single dose based on RP2D in phase II.
15940997|NCT03333902|Procedure|QLB|QLB, quadratus lumborum block.
15940998|NCT03333902|Procedure|Intravenous patient controlled analgesia (PCA)|Intravenous patient controlled analgesia (PCA) pump was used to supply additional analgesia and removed 48 h post-operationally.
15940999|NCT03333889|Other|Vita Enamic hybrid crown|hybrid ceramic material in the form of mesoblocks where the ceramic block is attached to a ti base .The whole assembly is screw retained superstructure.
15941000|NCT03333889|Other|emax hybrid crown|high srength glass ceramic that can be milled in sections up to 1mm .
15941001|NCT03333876|Device|Nasal Dilator|Mute is a pair of nasal dilators that fit snugly in the nose of the snorer dilating the nostrils to help reduce or eliminate snoring. This is an over-the-counter (OTC) product and is cleared by FDA for use in the United States. The introduction video for Mute is located at http://mutesnoring.com/how-to-use/.
15941002|NCT03333876|Device|Mandibular Advancement|"For purposes of this trial, we will be using an investigational myTAP V, which is not available for commercial use. The changes from the released product are: a vertical offset (+3mm) has been added to the design of the adjustment post and mechanism to improve overall comfort.
~myTAPTM is a mandibular advancement device used for snoring relief. The product requires a prescription and is cleared by FDA for use in the United States."
15941003|NCT03333876|Device|Positional Therapy|Sleep Positional Trainer (SPT) is a small device worn around the chest with an ergonomic band that continuously monitors the sleep position of the snorer. When the snorer is supine, it emits a gentle vibration to remind them to turn to the side to help reduce or eliminate their snoring.
15941004|NCT03333863|Other|descriptive study which reviewed the data of patients hospitalized with positive bacterial cultures|A retrospective, descriptive study was conducted at shengjing hospital of China Medical University between 2015- 2017. Data regarding bacterial culture isolates, antimicrobial susceptibility spectrum, and the general data of patients with fever or suspicion of sepsis were collected.
15941005|NCT03333850|Device|Visual feedback of physical activity|A monitor (tablet) will display the level of physical activity during hospitalisation. The monitor will be placed at the bedside (table).
15941006|NCT03333850|Device|No feedback of physical activity|There will be no visual feedback of the physical activity (no monitor placed at the bedside (table)).
15941007|NCT03333850|Device|Measurement of physical activity|A pair of accelerometers placed on the chest and on the thigh will measure the physical activity level during hospitalisation. The measurement is made continuously and stored on a secure web-server.
15941008|NCT03333837|Behavioral|Dance Group|Active imagination refers to working with imagery and is crucial in improvisatory practice. Verbal auditory cues are used to create movement scenarios that cue or activate the motor imagination. Variability means the improvisational method does not aim to learn a specific movement pattern and habituate to it. Cues are delivered quickly, one after another. Within an average of two minutes, tasks requiring quicker decision-making are introduced. Pacing is the rate at which new movement prompts are presented. Quick changes in pace avoid defaulting to habitual responses, thereby facilitating new movement options. Participants cannot rely on copying another, memory, or anticipation to address the motor problem.
15941009|NCT03333837|Behavioral|Non-Group Dance|The caregiver will be asked to stay in the area while the subject is dancing. A video camera will be affixed in an upper corner of the room to record individual dance sessions. This recording will yield data that a trained student or staff member can view and code to document movement fidelity (e.g., that the person has responded to the dance prompts and for the purpose of comparing the amount of quality of movements that occur in individual vs. group dance settings). For the first two sessions, study staff would observe the full dance session from outside the room to be sure that instruction was clear and adherence was attained, and that no safety issues arise.
15941069|NCT03333408|Drug|Postoperative Oral Antibiotics (Clindamycin or Augmentin)|Patients will receive postoperative oral antibiotics (Clindamycin or Augmentin) for 10-14 days upon discharge.
15941010|NCT03333837|Behavioral|Social Group|The social group will consist of improvisational party games to foster curiosity and playfulness, use imagery, and encourage non-judgment. Games that may be used include 'Balderdash', 'Wise and Otherwise', 'Charades', 'Pictionary', and 'Tell Me A Story' cards. These games will also use the same core strategies as the dance group. Games will be varied within an hour-long session to incorporate pacing and variability into the social group, akin to the dance group. The social group will occur 2x/week for 1 hour each time and be led by the same instructors who lead the Dance Group, to control for effects of personality of the group leader.
15941011|NCT03333837|Behavioral|No Contact|The condition of not receiving an intervention can have ethical implications and reduce retention rates. Therefore, these participants will be invited to join in a weekly community improvisational dance class after they complete the study, for as many sessions as they would like.
15941012|NCT03333824|Drug|CYP1A2 (caffeine)|In Part A, Period 1, patients will be administered a 3 drug cocktail of caffeine, omeprazole and midazolam on Day -8 followed by a washout period of at least 7 but no more than 14 days. In Part A, Period 2, AZD1775 capsules will be administered orally, 225 mg bid, until steady state for 2.5 days (total of 5 doses) and administered together with the cocktail on the morning of Day 3.
15941013|NCT03333824|Drug|CYP2C19 (omeprazole)|In Part A, Period 1, patients will be administered a 3 drug cocktail of caffeine, omeprazole and midazolam on Day -8 followed by a washout period of at least 7 but no more than 14 days. In Part A, Period 2, AZD1775 capsules will be administered orally, 225 mg bid, until steady state for 2.5 days (total of 5 doses) and administered together with the cocktail on the morning of Day 3.
15941014|NCT03333824|Drug|CYP3A (midazolam)|In Part A, Period 1, patients will be administered a 3 drug cocktail of caffeine, omeprazole and midazolam on Day -8 followed by a washout period of at least 7 but no more than 14 days. In Part A, Period 2, AZD1775 capsules will be administered orally, 225 mg bid, until steady state for 2.5 days (total of 5 doses) and administered together with the cocktail on the morning of Day 3.
15941015|NCT03333824|Drug|Kytril (granisetron)|Patients should be administered Kytril (granisetron) 1 mg orally, under fasted conditions (-2 to 2 hours away from meals), 30 minutes prior to administration of the AZD1775 capsules with a small amount of water.
15941016|NCT03333824|Drug|Wee-1 kinase inhibitor AZD1775|Multiple doses of 225 mg AZD1775, (3 x 75 mg, printed capsules) administered orally. The drug class of AZD1775 is Wee-1 kinase inhibitor.
15941017|NCT03333798|Behavioral|Cognitive-Behavioral Intervention|"A Cognitive-Behavioral intervention will be delivered by psychologists with LPCWs support. LPCWs who will be under the supervision and guidance of psychologists.
~Volunteers will receive 11 weekly sessions of which six will be provided by psychologists and five by LPCWs.
~The Cognitive-Behavioral component will be delivered through a set modules that will cover the following components:
~The Cognitive-Behavioral model
~Tackling traumatic events
~Cognitive reprocessing
~Relaxation techniques
~Prevention of revictimization
~Behavioral reactivation for the start of a new life The intervention will be given within the health system and volunteers will be seen if necessary by an interdisciplinary team including social workers, general physicians and psychiatrists."
15941018|NCT03333798|Behavioral|Standard psychosocial care|"The active control group will receive standard psychosocial care for intimate partner violence, provided by the participating health centers. Standard care is delivered by psychologists, social workers, general physicians and psychiatrists. Additionally, patients receive extramural support which includes telephone calls or domiciliary visits from a variety of health professionals (doctors, nurses, social workers and nursing assistants).
~Psychology consultations typically occur every four weeks in each health center. Psychologists use a variety of approaches according to their personal preferences, including humanist, psychoanalytic, psychodynamic and cognitive-behavioral approaches. At the end of the intervention psychologists will be asked which approach or approaches they used."
15941019|NCT03333785|Behavioral|eOncoNote|"Diagnosis phase: The patient's nurse navigator will initiate an eOncoNote to the patient's PCP, inviting them to send any questions related to the patient's diagnostic process. The nurse navigator will initiate case closure after the diagnostic process has been completed (case will be open up to 4 months).
~Treatment phase: The patient's medical or radiation oncologist will initiate an eOncoNote to the patient's PCP inviting them to ask questions related to the patient's cancer treatment and/or request information related to the patient's co-morbidities. The oncologist will initiate case closure after the treatment has been completed.
~Survivorship phase: The patient's registered nurse within the Wellness Beyond Cancer Program will send an eOncoNote invitation to the patient's PCP inviting them to ask any questions as the patient transitions back to their care. The nurse will initiate case closure after one year."
15941020|NCT03333772|Behavioral|REAL-T Intervention|Individualized lifestyle intervention conducted via internet-based videoconferencing and incorporating the following topics: Diabetes knowledge; access to healthcare; communication with healthcare providers; incorporation of diabetes self-care tasks within daily habits and routines; social support; and emotional well-being. Participants will have approximately 6-10 sessions lasting about one hour each, over a 3-month period.
15941021|NCT03333759|Device|Alma - Harmony XL Laser|The Erbium YAG laser at a 2940nm wavelength is used for ablative laser resurfacing as well as treating acne scars.
15941022|NCT03333746|Other|Laboratory Biomarker Analysis|Correlative studies
15941023|NCT03333746|Drug|Lenalidomide|Given PO
15941024|NCT03333746|Biological|Nivolumab|Given IV
15941025|NCT03333746|Other|Pharmacological Study|Correlative studies
15941026|NCT03333733|Behavioral|HENRY|"HENRY is an 8-week programme delivered in Children's Centres, aiming to provide parents with skills and knowledge to support healthy lifestyles in preschool children and their families. It is currently delivered in ~ 35 local areas across England and Wales by trained health and community practitioners. Training includes:
~Centre Level Training: to equip staff with knowledge and skills to promote and provide healthy nutrition within early years settings and support parents to provide healthy family lifestyles and nutrition for their families. The theoretical underpinning combines proven models of behaviour change including the Family Partnership Model, motivational interviewing and solution-focused support.
~Practitioner Level Training: to deliver the 8-week HENRY programme, which aims to build parents' skills, knowledge and confidence to change old habits and provide healthier nutrition for their young children."
15941112|NCT03333109|Other|Placebo|Matching placebo in pre-filled syringe administered subcutaneously
15941336|NCT03331523|Drug|Placebo|Placebo of Calcipotriene/ betamethasone dipropionate topical suspension, 0.005%/0.064% (Glenmark Pharmaceuticals Ltd.)
15941027|NCT03333720|Dietary Supplement|Phenylalanine-free protein substitute tablets|Thirty eligible PKU patients (≥ 8 years), identified as current tablet users, will be recruited to this study. Patients will firstly observe a 7-day baseline period. During baseline, patients will continue with their existing diet and protein substitute prescription before receiving Phenylalanine-free protein subsitute tablets daily for 28 days in addition to appropriate nutritional management.
15941028|NCT03333707|Behavioral|Pacifica App|The app contains several activities which are digital implementations of standard psychotherapy practices. Users may select which app elements they would like to use, and when. These app elements include relaxation and meditation activities, tools to examine your thoughts or self-talk, goal setting lists, and mood and health ratings. The app also has a peer support community where users can communicate with others who are having similar experiences. There is no minimum requirement for amount of time spent on any given activity, or in the app in total. The commercially available app has a feature to connect users to their existing healthcare providers, but this feature will not be available to study participants. Study participants may continue to see their existing providers.
15941029|NCT03333694|Drug|Cutaneous Cream application|Cutaneous Cream application twice daily with experimental (CLL442)
15941030|NCT03333694|Drug|Placebo Cutaneous Cream application|Cutaneous Cream application twice daily with placebo
15941031|NCT03333681|Biological|Autologous mesenchymal stem cells|A single intravenous administration of autologous bone marrow derived mesenchymal stem cells(1000000 to 2000000 cells/Kg)
15941032|NCT03333668|Drug|Lisdexamfetamine dimesylate|Lisdexamfetamine dimesylate (30mg for smaller, 50mg for larger boys) tablet
15941033|NCT03333668|Drug|Guanfacine Extended Release Oral Tablet|Guanfacine Extended Release (0.05mg/kg) tablet
15941034|NCT03333668|Drug|Placebo|Vitamin C (10mg) tablet
15941036|NCT03333642|Procedure|Duodenal Ileal Interposition with Sleeve Gastrectomy|Laparoscopic or open Duodenal Ileal Interposition with Sleeve Gastrectomy
15941037|NCT03333629|Behavioral|Enhanced early detection|standardized screening
15941038|NCT03333616|Drug|Ipilimumab|is an immunotherapy medication that stimulates the immune system to fight cancer cells throughout the body.
15941039|NCT03333616|Drug|Nivolumab|Nivolumab binds to and blocks the activation of PD-1. This results in the activation of T-cells and cell-mediated immune responses against tumor cells
15941040|NCT03333603|Drug|esomeprazole|esomeprazole 40mg /tab oral Day1-Day14 then 40mg/2 tab oral Day15-Day56
15941041|NCT03333590|Biological|rAAVrh74.MCK.GALGT2|Adeno-associated virus serotype rh74 carrying the GALGT2 gene under the control of a MCK promoter (rAAVrh74.MCK.GALGT2) will be delivered one time to each of the lower limbs through the femoral artery using an intravascular limb infusion technique (ILI)
15941042|NCT03333577|Device|SoundArc|non-surgical attachment method for wearing a bone conduction hearing system
15941043|NCT03333564|Dietary Supplement|VD3|50,000 IU VD3 / week for 8 weeks
15941044|NCT03333564|Dietary Supplement|Omega3-FA|300 mg of omega3-FA once daily for 8 weeks
15941045|NCT03333564|Dietary Supplement|VD3 and Omega-3FA|50,000 IU VD3 / week for 8 weeks and 300 mg of omega-3FA once daily for 8 weeks
15941046|NCT03333564|Other|Control|No intervention was given
15941047|NCT03333551|Drug|F18 Florbetapir (amyvid) cardiac PET/CT imaging|Patients with cardiac amyloidosis (AL) undergoing planned plasma cell directed chemotherapy will have F-18 florbetapir (amyvid) cardiac PET/CT imaging prior to starting chemotherapy and six months after onset of treatment.
15941048|NCT03333538|Biological|GamEvac-Lyo (component A)|Biological: GamEvac-Lyo (vaccine) vaccination, single administration, component A
15941049|NCT03333538|Other|Placebo|Placebo vaccination
15941050|NCT03333538|Biological|GamEvac-Lyo (component B)|Biological: GamEvac-Lyo (vaccine) vaccination, single administration, component B
15941051|NCT03333538|Biological|GamEvac-Lyo|Biological: GamEvac-Lyo (vaccine) vaccination, therapeutic scheme: the sequential introduction of components A and b with an interval of 21 days
15941052|NCT03333525|Other|Calculation of insulin dosages for different meals|Calculation of insulin dosages For CARB counting meals using insulin-carbohydrate ratio for dosing mealtime boluses. For fat protein counting meal ICR and additionally fat-protein unit were used for dosing of mealtime boluses.
15941053|NCT03333512|Behavioral|Nap|Looking at the difference between continuous sleep opportunities and split-sleep opportunities.
15941054|NCT03333499|Drug|YanXinShi placebo pills|participants will take matched 1800 mg YXS placebo pills TID in addition to the optimal combination drug treatment of heart failure
15941055|NCT03333499|Drug|YanXinShi pills|participants will take 1800 mg YXS pills TID in addition to the optimal combination drug treatment of heart failure
15941056|NCT03333499|Drug|Trimetazidine pills|participants will take 20mg Trimetazidine pills TID in addition to the optimal combination drug treatment of heart failure
15941057|NCT03333499|Drug|YanXinShi and Trimetazidine pills|participants will take 1800 mg YXS and 20 mg Trimetazidine pills TID in addition to the optimal combination drug treatment of heart failure
15941058|NCT03333486|Drug|Cyclophosphamide|Given IV
15941059|NCT03333486|Drug|Fludarabine Phosphate|Given IV
15941060|NCT03333486|Other|Laboratory Biomarker Analysis|Correlative studies
15941061|NCT03333486|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo PBSCT
15941062|NCT03333486|Radiation|Total-Body Irradiation|Undergo TBI
15941063|NCT03333473|Behavioral|PPFP Clinical and Counseling Skills|Facilities will receive whole-site orientations on PPFP basics and skills Through training of trainers, followed by classroom and model-based and clinical-based practice, providers will receive training in PPDP counseling and service provision.
15941064|NCT03333473|Behavioral|Facility-Level Leadership Management and Governance Training|The intervention will strengthen leadership management and governance practices required to help managers establish PPFP services at the facility level.
15941065|NCT03333460|Device|Repetitive Transcranial Magnetic Stimulation|rTMS is a non-invasive brain stimulation technique. The investigators will use a MagPro R30 with the Cool-B80 figure-of-eight coil (MagVenture, Falun, Denmark).
15941066|NCT03333447|Other|MRI|
15941067|NCT03333434|Device|Carbon Ankle Seven spring (A7 - Otto Bock, Germany)|
15941068|NCT03333434|Device|Hinged AFO|
15941196|NCT03332576|Drug|Cyclophosphamide|PO BID
15941070|NCT03333395|Drug|Nebulized heparin and salbutamol|HS Group medications (study group) (30 patients) which was prepared by adding Heparin 25000 IU in 5ml (5 ampoules of Heparin Sodium 5000 I.U/ML, Nile company for Pharmaceuticals and Chemical Industries-A.R.E.) to Salbutamol 5mg/2.5ml Nebulizer Solution (one Ventolin nebule containing a preservative-free solution of Salbutamol Sulphate BP 2.5mg, GlaxoSmithKline Inc.)
15941071|NCT03333395|Drug|Nebulized salbutamol|S Group medications (control group) (30 patients) which was prepared by adding Salbutamol 5mg/2.5ml Nebulizer Solution + Na cl 0.9% 5ml.
15941072|NCT03333382|Device|Plastic biliary stent|Plastic biliary stent which functions largely as a wick to siphon bile flow from the site of anastomotic leak.
15941073|NCT03333382|Device|FCSEMS|FCSEMS has a relatively larger expansile diameter and membrane coating to provide an actual seal at site of anastomotic leak.
15941074|NCT03333369|Drug|200 mg levodopa/50 mg benserazide|
15941075|NCT03333369|Drug|Dextrose|
15941076|NCT03333356|Radiation|pelvic radiotherapy|adjuvant pelvic radiotherapy consisting of 28 x 1.8 Gy fractions (total dose of 50.4 Gy), 5 days per week, 1 fraction / day (duration of RT is 38 days).
15941077|NCT03333343|Drug|EGF816|Study Drug
15941078|NCT03333343|Drug|trametinib|Study Drug
15941079|NCT03333343|Drug|ribociclib|Study Drug
15941080|NCT03333343|Drug|LXH254|Study Drug
15941081|NCT03333343|Drug|INC280|Study Drug
15941082|NCT03333343|Drug|gefitinib|Study Drug
15941083|NCT03333330|Drug|Visipaque 320 and SonoVue|"Intervention is related to the administration of contrast agents:
~Iodixanol, 320 mg of iodine per millilitre, Visipaque 320 (GE Healthcare, Milwaukee, WI, USA) for contrast-enahnced CTA, Sodium hexafluoride (SonoVue, Bracco Imaging, Milan, Italy) for CEUS"
15941084|NCT03333317|Drug|Lumicitabine|Participants will receive oral administration of lumicitabine.
15941085|NCT03333317|Drug|Placebo|Participants will receive oral administration of matching placebo.
15941086|NCT03333304|Diagnostic Test|Procalcitonin measurement|Discontinuation of antimicrobials according to Procalcitonin Kinetics
15941087|NCT03333291|Dietary Supplement|fecal suspension|helathy donor fecal suspension administered by duodenal scope
15941088|NCT03333278|Drug|Vitamin C|Ascorbic acid 1.5g every 6 hours i.v. while in ICU, until shock resolution for a maximum of ten days
15941089|NCT03333278|Drug|Thiamine|Thiamine 200mg every 12 hours i.v. while in ICU, until shock resolution for a maximum of ten days
15941090|NCT03333278|Drug|Hydrocortisone,|Hydrocortisone 50mg every 6 hours i.v while in ICU, until shock resolution or for a maximum of 7 days, then tapered or stopped.
15941091|NCT03333265|Drug|100mg Berberine hydrochloride|patients take the Berberine hydrochloride 100mg tablet by mouth, 2 times a day with 6 months
15941092|NCT03333265|Drug|300mg Berberine hydrochloride|patients take the Berberine hydrochloride 300mg tablet by mouth, 2 times a day with 6 months
15941093|NCT03333265|Drug|Placebo Oral Tablet|patients take mmic Berberine hydrochloride tablet by mouth, 2 times a day with 6 months
15941094|NCT03333252|Behavioral|Intervention Condition|Caregivers will access caregiving related information. Care Recipients will access cognitive training program
15941095|NCT03333252|Behavioral|Control Condition|Caregivers will access Nutrition and Health Promotion material. Care Recipients will access words and card games
15941096|NCT03333239|Behavioral|psychodynamic psychotherapy|the intervention follows the published in german manual: Psychoanalytische Behandlung von Kindern und Jugendlichen mit Angststörungen und Depressionen: Behandlungsmanual (Baumeister-Duru, Hofmann, Timmermann & Wulf, 2013)
15941097|NCT03333239|Behavioral|cognitive behavioral psychotherapy|the interventions follow the published in german manuals: Depression (Ihle, Groen, Walter, Esser, & Petermann, 2012) and Soziale Ängste und Leistungsängste (Büch, Döpfner, & Petermann, 2015)
15941098|NCT03333239|Behavioral|psychodynamic family intervention|the intervention follows an adapted version of the manual: Chimp´s - Children of mentally ill parents (Wiegand-Gefe, Halverscheid, & Plass, 2011)
15941099|NCT03333226|Procedure|Axillary Reverse Mapping (ARM)|ARM lymph node preservation versus removal
15941100|NCT03333213|Other|Gua Sha|
15941101|NCT03333200|Other|Palliative Care|Collecting information about the natural progression of these diseases
15941102|NCT03333200|Biological|Hematopoetic Stem Cell Transplantation|Following patients who have received HSCT as part of their clinical care.
15941103|NCT03333187|Procedure|Allogeneic stem cell transplantation|
15941104|NCT03333187|Drug|Ruxolitinib continuous therapy|
15941105|NCT03333174|Diagnostic Test|Cardiorespiratory monitoring|The investigators will use high resolution physiologic monitoring of Heart Rate, Respiratory Rate, Pulse oximetry, (and near-infrared monitoring as well as microcapnography in selected infants) to evaluate control of breathing (apnea, bradycardia, desaturations)
15941106|NCT03333161|Diagnostic Test|Cardiorespiratory monitoring|We will use high resolution physiologic monitoring of Heart Rate, Respiratory Rate, Pulse oximetry, (and near-infrared monitoring as well as microcapnography in selected infants) to evaluate control of breathing (apnea, bradycardia, desaturations).
15941107|NCT03333148|Drug|Nestle IMPACT Immunonutrition|Along with standard of care nutritional therapy patients (n=146) will be asked to consume 3 cartons/day for 14 days of Nestle IMPACT Advanced Recovery Immunonutrition.
15941108|NCT03333148|Other|Arm B- Standard of Care|No intervention standard of care nutrition (n=146).
15941109|NCT03333135|Device|Pulsed Electromagnetic Field|Therapy based on Biological Electromagnetic (BEM) microbial wave technology of the Pulsed Electromagnetic Field Therapy (PEMF). The device provides micro-magnetic emissions to the center of the palm (Laogong acupoint). While participating in the study, the subjects will undertake 2 sessions of therapy every day (1 session in the morning and evening). Each session will involve using the device on the Laogong acupoint for 16-min (8-min for left and 8-min for right hand).
15941110|NCT03333135|Device|Pulsed Electromagnetic Field Sham|The device will function and be used exactly the same as the real PEMF device except when turned on and performing a treatment it will not produce an micro-magnetic emissions. The device will be used on the center of the palm (Laogong acupoint) of each hand. While participating in the study, the subjects will undertake 2 sessions of therapy every day (1 session in the morning and evening). Each session will involve using the device on the Laogong acupoint for 16-min (8-min for left and 8-min for right hand).
15941111|NCT03333109|Biological|Erenumab|70 mg/mL pre-filled syringe administered subcutaneously
15941113|NCT03333096|Device|Ocusweep test battery|"Ocusweep test battery to measure vision, visual system and cognitive performance including attention
~(Comparison of Ocusweep system to conventional neuropsychological test methods)
~(With the help of Ocusweep tests, information is obtained about the functioning of the whole visual system - from the ability of the eye to see to the efficiency of the brain to process visual information and the accuracy of eye movements)"
15941114|NCT03333096|Diagnostic Test|Neuropsychological test battery|Conventional neuropsychological test battery to measure executive functioning, attention, visuoconstructive abilities and processing speed
15941115|NCT03333083|Drug|Raltegravir|Raltegravir (1200 mg once a day)
15941116|NCT03333083|Drug|Lamivudine|Lamivudine (300 mg once a day)
15941117|NCT03333070|Dietary Supplement|probiotic - Lactobacillus reuteri|The treated arm will receive 5 drops per day for 48 weeks
15941118|NCT03333070|Other|placebo - with no active ingredient|The control arm will receive 5 drops per day for 48 weeks
15941119|NCT03333057|Drug|NOV03|Perfluorohexyloctane
15941120|NCT03333057|Drug|Placebo|Saline solution (0.9% sodium chloride solution)
15941121|NCT03333044|Behavioral|Community Health Worker (CHW)-led health|Patients contacted a maximum of 10 times over 2 weeks to attend diabetes management sessions led by community health workers. Enrolled patients attend 5 Monthly group sessions led by a CHW held at the clinic
15941122|NCT03333044|Behavioral|HIT-enabled|During one on one visit, CHWs will assess social needs of patients using mobile technology. CHWs will give referral sources to patients generated by mobile app, and they will track through mobile app.
15941123|NCT03333044|Behavioral|Physician enabled care coordination|Forms on patient goal setting and referrals made are uploaded into EHR to physician
15941124|NCT03333031|Drug|HS-196|HS-196 will be administered intravenously as a single dose
15941125|NCT03333018|Drug|Aclidinium bromide|Administered as monotherapy, prescribed as recorded in the database.
15941126|NCT03333018|Drug|Aclidinium bromide/formoterol|Administered in combination with formoterol fumarate (concomitant or as a fixed-dose combination), prescribed as recorded in the database.
15941127|NCT03333018|Drug|Other COPD medication|"Other COPD medication including:
~tiotropium; other long-acting anticholinergic (LAMAs; lycopyrronium bromide, umeclidinium); LABA (formoterol, salmeterol, indacaterol); LABA/ICS (formoterol/budesonide, formoterol/beclometasone, formoterol/mometasone, formoterol/fluticasone, salmeterol/fluticasone propionate, and vilanterol/fluticasone); LAMA/LABA (approved or under regulatory review or in development; glycopyrrolate/formoterol, glycopyrronium/indacaterol, tiotropium/olodaterol, umeclidinium/vilanterol), prescribed as recorded in the database."
15941128|NCT03333005|Drug|APX001 with Standard of Care anti-fungal agent|safety assessment
15941129|NCT03332992|Behavioral|Viral changes|Telephone script language provided pre-questions regarding the fact that influenza viruses change each year
15941130|NCT03332992|Behavioral|Protect others|Telephone script language provided pre-questions emphasizing the need to protect vulnerable others
15941131|NCT03332992|Behavioral|General intentions|Question language asking about general interest in getting influenza vaccination
15941132|NCT03332992|Behavioral|Behavioral intentions|Question language asking individual to make specific plans to be vaccinated
15941133|NCT03332992|Behavioral|Accountability|Question language asking individual whether their care team can learn about their vaccination intentions
15941134|NCT03332966|Diagnostic Test|Psychiatric questionnaires|"Participants will fill in the following questionnaires as part of routine intake assessments:
~Generalised Anxiety Disorder Assessment (GAD-7); Mini-Social Phobia Inventory; Beck Depression Inventory 21A; Pittsburgh Sleep Quality Index; Insomnia Severity Index; Youth Experiences and Health Questionnaire; Adolescent Dissociative Experiences Scale (abbr.); Adolescent Peer Relations Instrument (APRI-B + cyberbullying, abbr.); Adolescent Trauma and Dissociation Scale (abbr.); Alcohol Use Disorders Identification Test; Alcohol, Smoking and Substance Involvement Screening Test - Lite (extended); Nicotine Questionnaire incl. Heavy Smoking Index; Internet Addiction Test (abbr.); European School Survey Project on Alcohol and Other Drugs 2015 Social Media Use and Computer Gaming; McMaster Family Assessment Device - General Functioning positive items; Multidimensional Scale of Perceived Social Support; Brief Resilience Scale; The Short Warwick-Edinburgh Mental Well-Being Scale"
15941135|NCT03332966|Diagnostic Test|Semi-structured psychiatric interview|Kiddie Schedule for Affective Disorders and Schizophrenia, version K-SADS-PL 2013.
15941136|NCT03332953|Other|E-cigarettes with varying concentrations of nicotine & flavor|Subjects will be asked to vape various e-cigarettes containing e-liquids at three concentrations of nicotine and sweet flavor (9 stimuli per subject).
15941137|NCT03332940|Drug|Tc 99M Sulfur Colloid|Sulfur colloid is a radiotracer that is indicated for imaging areas of functional reticuloendothelial cells in the liver, spleen, and bone marrow.
15941138|NCT03332940|Drug|Tc99m-tilmanocept|Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
15941139|NCT03332927|Other|Egg based breakfast foods|Two eggs/day, 6 days per week provided as breakfast foods such as burrito-type roll-up, egg sandwich and omelet.
15941140|NCT03332927|Other|Non-egg based breakfast foods|Non-egg based control foods provided as breakfast foods 6 days per week such as waffles, ready-to-eat cereal, fruits and cheeses.
15941141|NCT03332914|Device|Microcurrent therapy|The microcurrent therapy will be applied with electrodes that are fixed around the knee. The two electrodes of channel A will be placed at the inner and outer side of the knee that is most affected by pain. The two electrodes of channel B will be placed above and below the patella. An apparatus with CE certificate will be used.
15941142|NCT03332901|Other|this is an observational study, no intervention required|this is an observational study, no intervention required
15941143|NCT03332888|Drug|Rituximab|Rituximab will be studied in patients with HFrEF, and verify the patients safety.
15941144|NCT03332875|Behavioral|OurRelationship Online Program|OurRelationship.com is an online program designed to improve distressed romantic relationships.
15941145|NCT03332862|Procedure|catheter ablation|catheter ablation for atrial fibrillation treatment
15941146|NCT03332849|Biological|HM12470|HM12470 is a long-acting insulin analogue
15941147|NCT03332836|Biological|HM12460A|HM12460A is a long-acting insulin
15941334|NCT03331523|Drug|Calcipotriene/Betamethasone Dipropionate|Topical suspension 0.005%/0.064% (Glenmark Pharmaceuticals Ltd)
15941483|NCT03330457|Drug|Betrixaban 80 mg PO QD|fXa inhibitor
15941148|NCT03332823|Behavioral|SME Ambassadors training & program|"Two train-the-ambassador workshops: to train the ambassadors on positive thinking and understanding of adult mental health problem (in particular the mixed anxiety and depressive disorder) and mental well-being.
~The trained SME ambassadors will provide voluntary services and promote mental well-being messages to vulnerable groups, such as ex-mental illness people, new arrivals, etc."
15941149|NCT03332810|Behavioral|SME family based physical activity|"One train-the-trainer workshop: to train the service providers from 8-15 NGO service units on the concept of SME, ways of conducting mental well-being activities and knowledge of adult mental health problem (in particular the mixed anxiety and depressive disorder).
~Two SME family-based physical activities held by each NGO service unit: to organize enjoyable activities according to the needs of individual district as well as to promote positive psychology under the theme of SME. All these activities are organized by the NGO service providers in collaboration with District Healthy City Committee."
15941150|NCT03332810|Behavioral|Gathering activity|- Gathering activities will be held for control groups. However, SME concept or techniques will not be introduced during the activity. Physical activity will not be used as the intervention method.
15941151|NCT03332797|Drug|GDC-9545|GDC-9545 will be administered orally, once daily, on Days 1-28 of each 28-day cycle, until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
15941152|NCT03332797|Drug|Palbociclib|Palbociclib will be administered orally, once daily, at the label-recommended dose of 125 mg on Days 1-21 of each 28-day cycle, until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
15941153|NCT03332797|Drug|LHRH Agonist|The LHRH agonist will be administered by injection once every 4 weeks on Day 1 of each 28-day cycle, according to the label. The investigator will choose the appropriate LHRH agonist approved for use in breast cancer.
15941154|NCT03332784|Drug|TAK-925|TAK-925 Intravenous Infusion
15941155|NCT03332784|Drug|Placebo|TAK-925 Placebo Intravenous Infusion
15941156|NCT03332771|Drug|Sotagliflozin (SAR439954)|"Pharmaceutical form: tablet
~Route of administration: oral"
15941157|NCT03332771|Drug|Glimepiride|"Pharmaceutical form: capsule
~Route of administration: oral"
15941158|NCT03332771|Drug|Metformin|"Pharmaceutical form: tablet
~Route of administration: oral"
15941159|NCT03332771|Drug|Placebo|"Pharmaceutical form: tablet
~Route of administration: oral"
15941160|NCT03332771|Drug|Placebo|"Pharmaceutical form: capsule
~Route of administration: oral"
15941161|NCT03332758|Procedure|Pars plana vitrectomy|Standard of care treatment for retinal detachment, macular hole, or epiretinal membrane.
15941162|NCT03332758|Procedure|External drainage|Standard of care treatment for retinal detachment.
15941163|NCT03332732|Drug|VNRX-5133|β-lactamase inhibitor
15941164|NCT03332732|Drug|VNRX-5022|Approved β-lactam antibiotic
15941165|NCT03332732|Drug|Metronidazole|Approved antibiotic and antiprotozoal medication
15941166|NCT03332732|Drug|Placebo|Placebo (matching VNRX-5133 + VNRX-5022)
15941167|NCT03332719|Biological|Etanercept|
15941168|NCT03332719|Drug|Methotrexate|
15941169|NCT03332706|Other|observation|after the subjects are included into the groups,they are asked to do a questionaire.Then,we just observe the outcomes of pregnancy
15941170|NCT03332693|Other|Exercise|Leg weight raising
15941171|NCT03332693|Other|No exercise|Volunteers will not participate in exercise
15941172|NCT03332680|Biological|EmbryoGlue® (laboratory culture medium)|Embryos placed in this medium prior to transfer
15941173|NCT03332680|Biological|Standard control medium|Embryos placed in this medium prior to transfer
15941174|NCT03332667|Radiation|131I-MIBG|Patients will receive 131I-MIBG on day 1. 131I-MIBG dose will be based on the dose level assigned at the time of patient registration
15941175|NCT03332667|Drug|Ch14.18 Monoclonal Antibody|Dinutuximab is given intravenously on days 8-11 and 29-32 of therapy. Dinutuximab dose will be based on the dose level assigned at the time of patient registration.
15941176|NCT03332667|Drug|Vorinostat|Vorinostat will be given on day 0-13. Vorinostat dose will be based on the dose level assigned at the time of patient registration.
15941177|NCT03332654|Other|Determine prevalence of stress urinary incontinence|
15941178|NCT03332641|Dietary Supplement|Citron peel extract|Citron peel extract for 12 weeks
15941179|NCT03332641|Dietary Supplement|Placebo|Placebo for 12 weeks
15941180|NCT03332628|Device|Microneedle patch|Each patch contains 50 microneedles.
15941181|NCT03332615|Behavioral|Motivational Interviewing|Clinicians in the intervention arm will be taught Motivational Interviewing via a coaching model in which a didactic session is followed by feedback through review of clinicians' audio-recorded encounters.
15941182|NCT03332615|Behavioral|Wait-list control|After consent, clinicians in the wait-list control arm will complete a survey to self-assess their motivational interviewing skills and burnout.
15941183|NCT03332602|Dietary Supplement|free FeSO4|Testmeal with free FeSO4
15941184|NCT03332602|Dietary Supplement|free FeSO4 and empty microspheres|Testmeal with free FeSO4 and empty micropsheres
15941185|NCT03332602|Dietary Supplement|free FeSO4 and hylauronic acid|Testmeal with free FeSO4 and hyaluronic acid
15941186|NCT03332602|Dietary Supplement|free FeSO4 and eudragit polymer|Testmeal with free FeSO4 and eudragit polymer
15941187|NCT03332602|Dietary Supplement|encapsulated FeSO4 3.2%|Testmeal with encapsulated FeSO4 with 3.2% Fe loading
15941188|NCT03332602|Dietary Supplement|encapsulated FeSO4 20%|Testmeal with encapsulated FeSO4 with 20% Fe loading
15941189|NCT03332602|Dietary Supplement|encapsulated FeSO4 3.2%, encapsulated Vitamin A|Testmeal with encapsulated FeSO4 with 3.2% Fe loading, and encapsulated Vitamin A
15941190|NCT03332602|Dietary Supplement|encapsulated FeSO4 3.2%, encapsulated Vitamin A, free Folic Acid|Testmeal with encapsulated FeSO4 with 3.2% Fe loading, and encapsulated Vitamin A, with free folic acid.
15941191|NCT03332602|Dietary Supplement|FeSO4 embedded in Hyaluronic acid|Testmeal with FeSO4 embedded in Hyaluronic acid
15941192|NCT03332589|Drug|E6201|E6201 for Injection formulated in cyclodextrin for IV administration
15941193|NCT03332589|Drug|E6201 plus dabrafenib|E6201 for Injection formulated in cyclodextrin for IV administration plus oral dabrafenib capsules
15941194|NCT03332576|Biological|DPX-Survivac|SubQ injection
15941195|NCT03332576|Biological|DPX-Survivac(Aqueous)|SubQ injection
15941197|NCT03332563|Behavioral|Cognitive-behavioral intervention for chronic pain|WebMAP is a technology-based cognitive-behavioral intervention program that teaches relaxation skills, pain coping strategies and parent behavioral and communication techniques to youth with chronic pain and their parents.
15941198|NCT03332550|Procedure|Laparoscopic lavage|Operation with laparoscopic lavage for perforated diverticulitis Hinchey 3
15941199|NCT03332550|Procedure|Colon resection|Operation with colon resection for perforated diverticulitis Hinchey 4
15941200|NCT03332537|Behavioral|Personalized IBS Pain SM|
15941201|NCT03332524|Drug|SP160412 Ibuprofen 400 mg and Chlorpheniramine maleate 4 mg|2 Ibuprofen and capsules Chlorpheniramine maleate 3 time per day for 72 hours
15941202|NCT03332524|Drug|2 capsules Ibuprofen and 1 placebo|Ibuprofen and placebo
15941203|NCT03332524|Drug|capsule Chlorpheniramine 4mg and 1 Placebo|Chlorpheniramine 4mg and one capsule Placebo 3/72days
15941204|NCT03332511|Drug|Nilotinib|Nilotinib 300mg twice-daily
15941205|NCT03332498|Drug|Pembrolizumab|200 milligrams of pembrolizumab will be given through an IV (intravenously) for about thirty minutes. Pembrolizumab is an anti-PD1 that functions by inhibiting checkpoint inhibition and reversing T cell suppression.
15941206|NCT03332498|Drug|Ibrutinib|Ibrutinib oral capsules every day starting on cycle 1, day 1. Ibrutinib is primarily a BTK inhibitor which has been approved for the treatment of several hematologic malignancies.
15941207|NCT03332485|Drug|ECP Colon Prep Kit|ECP Colon Prep Kit
15941208|NCT03332485|Drug|MoviPrep®|MoviPrep®
15941209|NCT03332472|Other|Telemedicine group|
15941210|NCT03332472|Other|Conventional group|
15941211|NCT03332459|Drug|Lumicitabine|Participants who received lumicitabine in a feeding Phase 2 study (64041575RSV2004) will be observed in this study.
15941212|NCT03332459|Drug|Placebo|Participants who received placebo in a feeding Phase 2 study (64041575RSV2004) will be observed in this study.
15941213|NCT03332446|Other|cold water immersion|10 min at 12-15°C
15941214|NCT03332433|Device|High-flow nasal cannula oxygenation|Oxygen is supplied with a high-flow nasal cannula oxygenation device，the flow is up to 60L/min
15941215|NCT03332381|Behavioral|Attention training technique|Attention training involves modifying metacognitive control and enhancing attention flexibility so that people can refrain from responding to intrusions with extended processing.
15941216|NCT03332381|Behavioral|Mindful self-compassion|Self-compassion involves not avoiding painful or distressing feelings. Instead these experiences are held in awareness with kindness, understanding, and a sense of shared humanity.
15941217|NCT03332368|Other|Traditional Chinese medicine|Chinese medicine has a long history of prevention and treatment of breast cancer, the effect is obvious. Chinese medicine its mechanism of action is from the whole, adjust the body yin and yang, blood, viscera function balance, emphasizing the combination of governance and external treatment of the combination of thinking, according to different clinical syndromes, using syndrome differentiation.
15941218|NCT03332355|Drug|PAC-1 Compound|PAC-1 in combination with temozolomide (Component 2): after the MTD is established for single agent PAC-1 in Component 1, a modified-Fibonacci dose-escalation 3+3 design starts in Component 2, at a PAC-1 dose one level lower than the MTD of PAC-1 established in the single agent PAC-1 component (i.e., Component 1). PAC-1 will be taken in the morning on days 1-21 in each 28 day cycle. Temozolomide 150 mg/m2 dose is given for the 5 days starting at day 8 of cycle 1 in cohorts of 3-6 patients. The combination cohort that reaches MTD will expanded to at least 9 patients, similar to the PAC-1 alone cohort at MTD.
15941219|NCT03332342|Other|Eye wash|Research subjects will perform a wash of their ocular surface with phosphate buffered saline
15941220|NCT03332329|Drug|Entecavir|Entecavir is used for 96 weeks
15941221|NCT03332329|Drug|Granulocyte Macrophage Colony Stimulating Factor|Granulocyte-macrophage colony stimulating factor is used intermittently from baseline to week 16 and from 60 to week 84
15941222|NCT03332329|Drug|Y peginterferon alfa-2b|Y peginterferon alfa-2b is used for 96 weeks
15941223|NCT03332329|Drug|HBV vaccine|60ug HBV vaccine is used every four week for 24 weeks
15941224|NCT03332316|Drug|Dexamethasone Sodium Phosphate|Dexamethasone injection
15941225|NCT03332316|Drug|Ropivacaine Hydrochloride Inj 2 mg/ml|Ropivacaine injection
15941226|NCT03332316|Drug|Sodium Chloride 9mg/mL|Sodium Chloride injection
15941227|NCT03332303|Drug|Estrace® Cream|Brand Product
15941228|NCT03332303|Drug|Estradiol Vaginal Cream|Generic formulation of the brand product
15941229|NCT03332303|Drug|Vehicle Cream|Has no active ingredient
15941230|NCT03332290|Behavioral|sport practice|the intervention was a training course lasting 10 days. It included 10 days of sports practice. For divers, diving was carried out using air at a maximum depth of 40-meters, with a maximum of one dives a day. For the multisport group (the non-divers), the course included kayaking, mountain climbing or hiking with a maximum of two activities a day.
15941231|NCT03332264|Device|SeQuent Please OTW|Dilatation of occluded or highly stenosed vessel with paclitaxel-coated balloon catheter
15941232|NCT03332264|Device|Eluvia Vascular Stent System|Dilatation of occluded or highly stenosed vessel with paclitaxel-coated stent
15941233|NCT03332264|Device|Nitinol stent|Dilatation of occluded or highly stenosed vessel with uncoated bare nitinol stent
15941234|NCT03332251|Device|Posture Correction Girdle|Participants will be invited to undergo a fitting session of posture correction girdle. After the fitting, participants will join a 6-month wear trial of the posture correction girdle. Participants are required to wear the girdle for 8 hours a day and the compliance will be recorded by a logbook daily. Participants will be invited to undergo assessments before the wear trial, after the trial of 3 months, and after the trial of 6 months. The measure outcomes of the assessment include 1) ultrasound scanning image, 2) 3D body scan, 3) electromyography signal, 4) garment pressure, and 5) questionnaire.
15941235|NCT03332238|Device|Autologous Stomal Vascular Fraction Material|Autologous Stomal Vascular Fraction Material Prepared from the Tissue Genesis® Icellator Cell Isolation System™
15941236|NCT03332238|Device|Ringer's solution|Ringer's solution
15941237|NCT03332225|Drug|Anakinra|Treatment with anakinra
15941238|NCT03332225|Drug|Recombinant human interferon-gamma|Treatment with recombinant human interferon-gamma
15941239|NCT03332225|Drug|Placebo|Treatment with Placebo
15941240|NCT03332212|Drug|Empagliflozin|12 weeks
15941241|NCT03332212|Drug|Placebo|12 Weeks
15941242|NCT03332199|Other|Psycho-educational intervention|The total program, consisting of three intervention sessions, was given over a period of 3 weeks. The one face-to-face session of an-hour's duration was provided within a week of the chemotherapy cycle following recruitment. Two booster sessions of 20-30 minutes were then conducted by phone at one-week intervals after the first intervention session.
15941243|NCT03332186|Drug|BMS-986231|Intravenous infusion administration
15941244|NCT03332173|Drug|BGB-3111|BGB-3111 160 mg twice daily(BID) (in 80 mg white opaque capsules) administered orally
15941245|NCT03332160|Device|Flexitouch head and neck lymphedema treatment system|Pneumatic compression device cleared for use by medical professionals and patients who are under medical supervision, for the treatment of many conditions such as: lymphedema; primary lymphedema; post mastectomy edema; edema following trauma and sports injuries; post immobilization edema; venous insufficiency; reducing wound healing time; treatment and assistance in healing stasis dermatitis, venous stasis ulcers, or arterial and diabetic leg ulcers. The Flexitouch system and garments for head and neck are intended for use by medical professionals and patients who are under medical supervision for the treatment of head and neck lymphedema.
15941246|NCT03332160|Other|Standard home lymphedema care|May include daily self manual lymphatic drainage, exercise, skin care, compression garments (as appropriate).
15941247|NCT03332147|Device|Investigational Group|The RHEA device and Philips Patient Monitor MX400 are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.
15941248|NCT03332147|Device|reference group-Earlysense system|The reference device Earlysense 2.0 system(vital sign monitoring system) and Philips Patient Monitor MX400 are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.
15941249|NCT03332134|Behavioral|Intimate Partner Violence (IPV) Prevention Intervention|The IPV intervention consists of six sessions. Each session will cover one of 6 major modules to enhance transformation of motivation: 1) You, Me, and Us: Spending Meaningful Time Together, 2) I'm a Champion: I Can't Be Broken and I don't Accept Defeat! 3) Building Communication and conflict management strategies, and 4) Empowerment of the Couple: Planning Ahead, 5) Sexual communication and the sexual relationships, and 6) A Lens into Domestic Violence. The sessions will be audio-recorded and include a combination of didactics, interactive discussions, media use, and role play. The expected durations of session 1, 2-6, and the 3-month follow-up are 120 minutes, and 60-90 minutes, respectively.
15941250|NCT03332121|Biological|B001|4 times intravenous injection totally,dosing at Day1,Day35,Day56,Day77
15941251|NCT03332108|Other|EpxBreastfeeding|"We developed an algorithm using the Epharmix platform, an automated toll-free phone and text message-based system that can programmatically query patients via their personal phones and subsequently collect response data, allowing clinically-relevant responses to trigger alerts to designated healthcare providers. The intervention for breastfeeding, hereafter referred to as EpxBreastfeeding, was built using significant clinical and patient input to only ask the most clinically-relevant questions for breastfeeding in a multiple-choice manner, such as In the past [x] days, have you fed your baby 1) breast milk only, 2) breast milk and formula or 3) formula only?. These communications elicit patient-reports of breastfeeding at intervals of interest for the provider, which is, on average, every 2 days in the first three weeks postpartum and every 5 days subsequently. All data is filtered by clinician-designed algorithms to stratify patients into categories."
15941252|NCT03332108|Other|Baby book survey|"We developed a baby book template that will be given to mothers allowing them to make note of dates related to their child's development during the first year. Examples include: When was baby's first appointment with his/her pediatrician? When did you add formula into baby's feeding? When did you start feeding baby only formula? When did you introduce solid food into baby's diet? When did baby first smile? When did you start reading to baby? What was the first book you read to baby? Whe"
15941253|NCT03332095|Drug|Doravirine (DOR)|100 mg of DOR administered orally
15941254|NCT03332095|Drug|Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF)|DOR/3TC/TDF administered orally as a fixed-dose combination (as a tablet, 100 mg/300 mg/300 mg, or as oral granules provided in three capsules that each contain 33.6 mg/100 mg/100 mg) once daily
15941255|NCT03332095|Drug|Antiretroviral (ARV) medications|Participants in Cohort 1 will be taking a combination of dolutegravir (DTG) or raltegravir (RAL) plus two nucleoside reverse transcriptase inhibitors (NRTIs). The ARV drugs will be prescribed by participants' own health care providers and will not be provided by the study.
15941256|NCT03332082|Procedure|Tooth positioner|Orthodontic Tooth positioners treatment have been used in the Orthodontic Industry for many years. These positioners are used for small minor movements to complete the final smile. These positioners are made from a biocompatible and FDA approved clear silicone material after the teeth have been set to the final position.
15941257|NCT03332069|Device|Modulated electro-hyperthermia|Modulated electro-hyperthermia device used is the EHY 2000 by Oncotherm GmbH
15941258|NCT03332069|Radiation|External beam radiation|
15941259|NCT03332069|Drug|Cisplatin|
15941260|NCT03332069|Radiation|Brachytherapy|High Dose Rate
15941261|NCT03332056|Drug|Belladonna and Opium|
15941262|NCT03332056|Other|Placebo suppository|
15941263|NCT03332043|Device|HIRREM|HIRREM (Brain State Technologies, Scottsdale, AZ) is a closed-loop, allostatic, acoustic stimulation neurotechnology that uses software-guided algorithmic analysis to identify and translate selected brain frequencies into audible tones of varying pitch and timing, to support real-time self-optimization of brain activity.
15941264|NCT03332043|Other|Ambient Nature Sounds|Digitally recordings of various ambient nature sounds such as a stream, waterfall, ocean waves, or rainfall, are provided via ear buds.
15941265|NCT03332030|Diagnostic Test|Collection of Stem Cells|One time collection of a 20 ml blood sample
15941266|NCT03332017|Drug|Zanubrutinib|BGB-3111 will be administered as two 80-mg capsules by mouth twice a day (160 mg twice a day)
15941267|NCT03332017|Drug|Obinutuzumab|Obinutuzumab will be administered 1,000 mg intravenously on days 1, 8, and 15 of cycle 1, then 1,000 mg on day 1 of cycles 2 to 6, then 1,000 mg every 8 weeks. 1 cycle = 28 days.
15941268|NCT03332004|Drug|Indocyanine Green|0.25 mg /(kg BW) Indocyanine Green PULSION® - PULSION Medical Systems were administered intravenously
15941269|NCT03331991|Biological|influenza vaccine|exposure to influenza vaccine
15941335|NCT03331523|Drug|Taclonex®|Calcipotriene/ betamethasone dipropionate topical suspension, 0.005%/0.064% (LEO Pharma Inc.)
15941484|NCT03330457|Biological|Andexanet alfa (infusion IV)|fXa inhibitor antidote
15941270|NCT03331978|Behavioral|Rise - Treatment Education|Rise consists of a one-month intensive intervention (with three core 60-minute counseling sessions at weeks 1, 2, and 4) followed by two booster sessions (at weeks 12 and 20). If participants show nonadherence during booster sessions, they are offered up to four additional booster sessions (i.e., extra booster sessions if <85% of prescribed doses were taken in the past month). Thus, participants receive three core sessions in the first month, followed by 2-6 booster sessions over the next four months.
15941271|NCT03331965|Drug|Metoclopramide 5 MG/ML Injectable Solution|A one-time dose of promotility agent (metoclopramide 10 mg in 10 mL saline IV) will be administered at the time of GJ placement.
15941272|NCT03331965|Drug|Saline|A one-time dose of a placebo (10 mL saline IV) will be administered at the time of GJ placement.
15941273|NCT03331952|Other|Prospective study|To identify and characterise patients with culture proven invasive pneumococcal disease or probable bacterial meningitis over the first three years after PCV13 introduction in Cambodia in January 2015.
15941274|NCT03331952|Other|Prospective study|To identify and characterise patients hospitalised with clinical and/or radiologic pneumonia over the first three years after PCV13 introduction in Cambodia in January 2015
15941275|NCT03331952|Other|Cross-sectional surveys|Three annual surveys, enrolling 450 children each year, will be done to identify and characterise pneumococcal nasopharyngeal colonisation in AHC out-patient department (OPD) attendees
15941276|NCT03331939|Other|no stimulation|Vagal nerve stimulator will be set to no stimulation
15941277|NCT03331939|Other|beta (25-30 Hz)|Vagal nerve stimulator will be set to beta (25-30 Hz)
15941278|NCT03331939|Other|Theta (5 Hz)|Vagal nerve stimulator will be set to beta (5 Hz)
15941279|NCT03331926|Drug|Xiapex|Follow-up of effect of treatment
15941280|NCT03331913|Drug|Botulinum Toxin type A (intradermal / submucosal injection at pain area)|Comparison of two different treatment methods of Botulinum Toxin type A for the treatment of trigeminal neuralgia
15941281|NCT03331913|Drug|Botulinum Toxin type A (intra-masseter injection on the ipsilateral of pain involved)|Comparison of two different treatment methods of Botulinum Toxin type A for the treatment of trigeminal neuralgia
15941282|NCT03331900|Drug|COR388|Administered as oral capsule
15941283|NCT03331900|Drug|Placebo|Administered as oral capsule
15941284|NCT03331887|Procedure|E-max CAD endocrown|endocrown used to restore endodontically treated teeth with E-max CAD endocrowns
15941285|NCT03331887|Procedure|E-max CAd crowns retained with fiber reinforced composite post|fiber reinforced composite post need to restore endodontically treated tooth with E-max crown
15941286|NCT03331874|Diagnostic Test|Reflectance Confocal Microscopy|In-vivo microscope
15941287|NCT03331861|Drug|Metformin hydrochloride|Metformin starting at 500mg twice a day and increasing to 1000mg twice a day for a total of 6 months
15941288|NCT03331861|Drug|Placebo|Similar dosing regime as active comparator
15941289|NCT03331848|Drug|Placebo oral capsule|BID
15941290|NCT03331848|Drug|PXT002331 - 20mg|Oral
15941291|NCT03331835|Biological|Brodalumab|Brodalumab is a recombinant fully human monoclonal immunoglobulin IgG2-antibody that binds with high affinity to human interleukin 17 receptor A (IL-17RA).> Blocking IL-17RA inhibits IL-17 cytokine-induced responses and results in reduced or normalised inflammation of the skin in subjects with psoriasis.
15941292|NCT03331835|Drug|Fumaric acid esters|Fumaric acid esters have been used to treat psoriasis since 1959. Systemic therapy with fumaric acid esters is based on an established dosing scheme with a gradual increase to improve tolerability, especially with regards to gastrointestinal side effects.
15941293|NCT03331822|Other|Bright Light|high illuminance white lights positioned at each nursing station throughout the hallway to generate a uniform exposure of approximately 1,000-3,000 lux. To achieve this illuminance, a Day*Light Classic Light will be positioned at each nursing station in the ICU hallway.
15941294|NCT03331809|Procedure|Two-handed jaw thrust|The assistant applied two-handed jaw thrust when intubating with double-lumen tube endotracheal tube.
15941295|NCT03331809|Procedure|Conventional intubation|The attending anesthesiologist provided intubation with double-lumen tube endotracheal tube without two-handed jaw thrust.
15941296|NCT03331796|Device|Active rTMS (Bilateral DLPFC)|TMS Stimulation Parameters for the active DLPFC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
15941297|NCT03331796|Device|Active rTMS (Bilateral LPC)|TMS Stimulation Parameters for the active LPC rTMS intervention group will be: 10 Hz, 4-second train duration and 11-second inter-train interval. During each session, 2,000 pulses will be applied for each hemisphere (for a total of 4,000 pulses per session). Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
15941298|NCT03331796|Device|Placebo rTMS (Inactive)|For the Placebo rTMS (Inactive) group, the participant will wear scalp electrodes through which a low voltage, low electric current (2-20mA at no more than 100V) is passed to mimic the sensation of receiving actual rTMS. Participants will receive 20 sessions (1 or 2 sessions per day, M-F).
15941299|NCT03331783|Other|Standard hydrocolloid adhesive patch|This patch is made of a standard hydrocolloid adhesive
15941300|NCT03331783|Other|LT-2|This patch is made of a new adhesive
15941301|NCT03331783|Other|LT-21|This patch is made of a new adhesive
15941302|NCT03331783|Other|33-20|This patch is made of a new adhesive
15941303|NCT03331770|Drug|Latanoprost Ophthalmic Product|Multidose bottle, preserved with potassium sorbate, that can be stored at room temperature up to 30°C during all shelf life, the emulsion does not require shaking before use
15941304|NCT03331757|Other|Glucose as reference food|Eleven subjects (male: 2, female: 9) consumed 50g glucose diluted in 300ml water, tested three times, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
15941305|NCT03331757|Other|Fir honey|Eleven subjects (male: 2, female: 9) consumed 50g available carbohydrates of fir honey diluted in 300ml water, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
15941306|NCT03331757|Other|Heather honey|Eleven subjects (male: 2, female: 9) consumed 50g available carbohydrates of heather honey diluted in 300ml water, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
15941307|NCT03331757|Other|Citrus honey|Eleven subjects (male: 2, female: 9) consumed 50g available carbohydrates of citrus honey diluted in 300ml water, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
15941308|NCT03331757|Other|Pine honey|Eleven subjects (male: 2, female: 9) consumed 50g available carbohydrates of pine honey diluted in 300ml water, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
15941309|NCT03331757|Other|Thyme honey|Eleven subjects (male: 2, female: 9) consumed 50g available carbohydrates of thyme honey diluted in 300ml water, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
15941310|NCT03331757|Other|Chestnut honey|Eleven subjects (male: 2, female: 9) consumed 50g available carbohydrates of chestnut honey diluted in 300ml water, tested once, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
15941311|NCT03331731|Drug|pembrolizumab|Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
15941312|NCT03331718|Drug|PGA felt reinforcement|During pancreaticojejunostomy, 1) a 0.3 mm thick PGA felt (Neoveil®, Gunze, Japan) is pasted on the ventral side and the dorsal side of pancreatic parenchyma, through which suture between pancreatic parenchyma and jejunum is performed. 2) Before abdominal closure (after completion of all reconstruction, after washing in the abdominal cavity), a 0.15 mm thick PGA felt is further covered around the anastomotic site and fibrin glue is sprayed.
15941313|NCT03331705|Device|Uro-C (Use of new cystoscope)|Diagnostic cystoscopic procedure of the urethra and bladder
15941314|NCT03331692|Other|monitoring of the proper level of general anesthesia|The monitoring of the adequate level of general anesthesia was performed both clinically and instrumentally.
15941315|NCT03331679|Behavioral|HIIT|2 Weeks of High Intensity Interval Training on a Cycle ergometer
15941316|NCT03331666|Drug|Evolocumab|140 mg every 14 days A monoclonal antibody designed for the treatment of hyperlipidemia
15941317|NCT03331653|Other|Dry Needling and Ischemic Compression at the Trigger Point|The intervention consist on dry needling in the active trigger point, and next, do ischemic compression in the same point.
15941318|NCT03331653|Other|Dry Needling and Ischemic Compression at 1.5 centimeters from the Trigger Point|The intervention consist on dry needling at 1.5 centimeters from the active trigger point, and next, do ischemic compression in the same point.
15941319|NCT03331640|Drug|OFF|"OFF:
~5-FU 2000 mg/m2 as 24 hour infusion + Na folinic acid 200 mg/m2 on D1, 8, 15, 22 Oxaliplatin 85 mg/m2 on D8, 22 3 weeks rest after D22; Cycle q42d"
15941320|NCT03331640|Drug|FOLFIRI Protocol|Irinotecan 180 mg /m2 5-FU 400 mg/m2 (bolus) + 2400 mg/m2 as 46 hour infusion Na folinic acid 200 mg/m2 Cycle q2w
15941321|NCT03331627|Drug|STR001-IT and STR001-ER|STR001-IT intrataympanic injection and STR001-ER tablet
15941322|NCT03331614|Device|Flowaid FA-100 SCCD|The SCCD is a contained external non invasive electric muscle pump. The device attaches to the rear of the calf with 4 electrodes.
15941323|NCT03331601|Drug|68GaNOTA-Anti-HER2 VHH1|Injection of the radiopharmaceutical and PET/CT 90 min post injection
15941324|NCT03331588|Procedure|Subxiphoid uniportal VATS|Patients were placed in a supine position, and the operating table was manipulated as needed to elevate the appropriate side of the body for surgery. The surgical procedures followed principles of pulmonary resections
15941325|NCT03331588|Procedure|Intercostal uniportal VATS|The surgical procedures followed principles of pulmonary resections
15941326|NCT03331575|Radiation|Arm1 (Hypofractionated radiotherapy)|hypofractionated RT（PTV-G60.5Gy/22Fx, 2.75Gy/Fx; PTV-C 49.5Gy/22Fx, 2.25Gy/Fx）, with concurrent chemotherapy : Cisplatin(20 mg/m2 d1) Docetaxel (20 mg/m2 d1),weekly, 6 cycles )
15941327|NCT03331562|Drug|Pembrolizumab|pembrolizumab solution for infusion
15941328|NCT03331562|Drug|paricalcitol|Paricalcitol solution for injection
15941329|NCT03331562|Drug|placebo|normal saline solution for injection
15941330|NCT03331536|Procedure|Roux en Y Gastric Bypass Pre-menopausal|The investigator aims to determine changes in skeletal health after Roux en Y Gastric Bypass in pre-menopausal women. Dual-energy x-ray absorptiometry (DXA) will be used to assess bone mineral density (BMD), including assessment for fracture risk (FRAX). Trabecular Bone Score (TBS) software will be used to adjust FRAX scores for bone microstructure and an enhanced fracture risk probability. Biochemical markers of bone metabolism and calcium homeostasis including serum bone alkaline phosphatase (BALP), osteocalcin, type 1 procollagen (P1NP), c-terminal telopeptide (CTX), calcium, albumin, parathyroid hormone (PTH), and 25-OH vitamin D will be assayed.
15941331|NCT03331536|Procedure|Roux en Y Gastric Bypass Post-menopausal|The investigator aims to determine changes in skeletal health after Roux en Y Gastric Bypass in post-menopausal women. Dual-energy x-ray absorptiometry (DXA) will be used to assess bone mineral density (BMD), including assessment for fracture risk (FRAX). Trabecular Bone Score (TBS) software will be used to adjust FRAX scores for bone microstructure and an enhanced fracture risk probability. Biochemical markers of bone metabolism and calcium homeostasis including serum bone alkaline phosphatase (BALP), osteocalcin, type 1 procollagen (P1NP), c-terminal telopeptide (CTX), calcium, albumin, parathyroid hormone (PTH), and 25-OH vitamin D will be assayed.
15941332|NCT03331536|Procedure|Sleeve Gastrectomy Pre-menopausal|The investigator aims to determine changes in skeletal health after Sleeve Gastrectomy in pre-menopausal women. Dual-energy x-ray absorptiometry (DXA) will be used to assess bone mineral density (BMD), including assessment for fracture risk (FRAX). Trabecular Bone Score (TBS) software will be used to adjust FRAX scores for bone microstructure and an enhanced fracture risk probability. Biochemical markers of bone metabolism and calcium homeostasis including serum bone alkaline phosphatase (BALP), osteocalcin, type 1 procollagen (P1NP), c-terminal telopeptide (CTX), calcium, albumin, parathyroid hormone (PTH), and 25-OH vitamin D will be assayed.
15941333|NCT03331536|Procedure|Sleeve Gastrectomy Post-menopausal|The investigator aims to determine changes in skeletal health after Sleeve Gastrectomy in post-menopausal women. Dual-energy x-ray absorptiometry (DXA) will be used to assess bone mineral density (BMD), including assessment for fracture risk (FRAX). Trabecular Bone Score (TBS) software will be used to adjust FRAX scores for bone microstructure and an enhanced fracture risk probability. Biochemical markers of bone metabolism and calcium homeostasis including serum bone alkaline phosphatase (BALP), osteocalcin, type 1 procollagen (P1NP), c-terminal telopeptide (CTX), calcium, albumin, parathyroid hormone (PTH), and 25-OH vitamin D will be assayed.
15941337|NCT03331510|Other|Strength testing before and after arthroscopic Latarjet|After patients, based on the ISI-Score, were assigned to treat their shoulder instability with an arthroscopic Latarjet procedure, they are eligible for this study. Strength of different involved muscles, as well as ROM will be measured before and at several time points after surgery.
15941338|NCT03331497|Procedure|Tonsillotomy|About 2/3 of the palatine tonsil tissue is removed with coplator or bipolar knife.
15941339|NCT03331484|Drug|Ticagrelor|Ticagrelor 90 mg twice daily
15941340|NCT03331484|Drug|Rivaroxaban|Rivaroxaban 15 mg once daily (10mg for patients with moderate renal impairment, creatinine clearance: 30-50 mL/min by the Cockcoft Gault method)
15941341|NCT03331471|Procedure|alveolar recruitment maneuver|applying alveolar recruitment maneuver using the anesthesia machine
15941342|NCT03331471|Procedure|conventional ventilation|conventional ventilation using the anesthesia machine
15941343|NCT03331458|Behavioral|exrecise intervention|Subjects will undergo pre-intervention measures, complete a daily physical activity diary, and post-intervention measures
15941344|NCT03331445|Drug|Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation|Inhaled Nitric Oxide 160ppm balance air
15941345|NCT03331432|Dietary Supplement|Tauroursodeoxycholic acid|Taking tauroursodeoxycholic acid (1750 mg/day) capsules for 4 weeks.
15941346|NCT03331432|Dietary Supplement|Placebo|Taking daily placebo capsules for 4 weeks.
15941347|NCT03331419|Behavioral|Exercise test|30 sec of knee squats followed by a six minute walk test repeated on consecutive days.
15941348|NCT03331406|Other|Physical Activity Program|12-weeks in length, and includes moderate-intensity aerobic, strength, flexibility, and balance training.
15941349|NCT03331393|Other|Non-interventional|Non-interventional
15941354|NCT03331367|Procedure|Blood draw|Patients in all four study arms will provide a blood sample to evaluate the immune response to prostate cancer treatment.
15941355|NCT03331367|Procedure|Urine sample|Patients in all four study arms will provide a urine sample to evaluate the immune response to prostate cancer treatment.
15941356|NCT03331354|Behavioral|Distant vocational learning|use of hybrid distance learning to facilitate successful employment outcomes
15941357|NCT03331354|Other|Basic vocational services|self-help manual
15941363|NCT03331328|Device|MonaLisa Touch|MonaLisa Touch is a fractional CO2 laser that has been specially designed with the DEKA pulse to stimulate vaginal tissue. It is delivered in a very precise manner and results in the synthesis of collagen and stratification of the vaginal epithelium with improvement of the vaginal pH and moisturization of the vaginal tissue due to increased blood flow and turgidity of the ground substance from the synthesis of the proteoglycans, hyaluronic acid and collagen.
15941364|NCT03331315|Drug|Celecoxib|
15941365|NCT03331315|Drug|Ketorolac|
15941366|NCT03331302|Drug|Hyperpolarized Xenon-129 MRI (Experimental)|MRI ventilation scan of the lung with inhaled contrast agent (hyperpolarized Xenon-129)
15941367|NCT03331302|Drug|Radioactive Xenon-133 scintigraphy (Active Comparator)|Radioactive ventilation scintigraphy of the lung with inhaled radioactive contrast agent (Xenon-133)
15941368|NCT03331289|Drug|Placebo|Placebo will be administered to 20 subjects after a 3 hour tracer equilibration period
15941369|NCT03331289|Drug|Exenatide|Exenatide will be administered to 20 subjects after a 3 hour tracer equilibration period
15941370|NCT03331289|Drug|Dapagliflozin|Dapagliflozin will be administered to 20 subjects after a 3 hour tracer equilibration period
15941371|NCT03331289|Drug|Exenatide and Dapagliflozin|Exenatide and Dapagliflozin will be administered to 20 subjects after a 3 hour tracer equilibration period
15941372|NCT03331276|Other|BBN|BBN to be feed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks.
15941373|NCT03331276|Other|Brand|Brand to be feed as the sole source of nutrition for 16 weeks to healthy term infants for 16 weeks.
15941374|NCT03331263|Drug|Chlorhexidine Gluconate|2% CHG
15941375|NCT03331250|Drug|Eribulin|It may work by preventing the cancer cells from dividing and eventually cause the tumor cells to die
15941376|NCT03331237|Procedure|scalene block|scalene block using 5ml of ropivacaine
15941377|NCT03331237|Procedure|ISO block|ISO block is a combined block of suprascapular nerve and brachial plexus cords using a single puncture
15941378|NCT03331224|Device|OTSC|OTSC placement
15941379|NCT03331224|Device|Endoscopic Standard therapy (combining two methods)|endoscopic standard therapy (two methods, e.g. clip and injection)
15941380|NCT03331211|Drug|TKIs|Dasatinib combined with Chematherapy
15941381|NCT03331198|Biological|JCAR017 (lisocabtagene maraleucel)|Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants will receive venetoclax as bridging anticancer therapy on a weekly ramp up dosing schedule until stopping one day prior to lymphodepletion. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection, and the day after infusion venetoclax will be re-initiated.
15941382|NCT03331198|Biological|JCAR017 (lisocabtagene maraleucel) + ibrutinib|Participants eligible for this cohort should be receiving ibrutinib at the time of screening. For participants who previously discontinued ibrutinib, ibrutinib will be started as soon as possible after eligibility is confirmed. Ibrutinib treatment will continue for up to 90 days after JCAR017 infusion (or longer for participants who are receiving benefit from ibrutinib). Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive bridging chemotherapy for disease control. Upon successful generation of JCAR017 product, participants will receive treatment with JCAR017 therapy. Each cycle will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection.
15941383|NCT03331198|Biological|JCAR017 (lisocabtagene maraleucel) + venetoclax|Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants will receive venetoclax as bridging anticancer therapy on a weekly ramp up dosing schedule until stopping one day prior to lymphodepletion. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection, and the day after infusion venetoclax will be re-initiated.
15941384|NCT03331185|Biological|Freeze Dried Bone Allograft|Human derived bone particles used in oral and periodontal grafting procedures
15941385|NCT03331185|Biological|L-PRF clot|L-PRF is a second-generation platelet rich plasma obtained from autologous blood and contains several different growth factors, platelets and leucocytes in a complex fibrin matrix to accelerate the healing of soft and hard tissues.
15941386|NCT03331172|Device|Echopulse|Echopulse is a real-time US-guided High-intensity focused ultrasound (HIFU) system, the HIFU session is a noninvasive procedure that involves application of a focused high-energy ultrasound beam for thermal tissue ablation inside the targeted zone, with minimal effect on the surrounding tissue
15941387|NCT03331159|Device|NanoBone|Cage was filled with nanocrystalline hydroxyapatite embedded in a silica gel matrix
15941388|NCT03331159|Device|Homologous Bone|Cage was filled with homologous bone
15941389|NCT03331146|Drug|Saline|A placebo (saline infusion) will be administered after induction of general anesthesia.
15941390|NCT03331146|Drug|Sodium Nitrite|Sodium nitrite infusion at a 267 mcg/kg/hr. will start after induction of general anesthesia via a dedicated IV line for 6 hrs.
15941391|NCT03331133|Other|No intervention|
15941392|NCT03331120|Device|ambulatory mirror image functional re-training through wearing 3D adjustable cervicothoracic Posture Corrective Orthotic(CTPCO)|Ambulatory a mirror image functional re-training This way of functional training will deliver via the use of adjustable cervicothoracic orthosis with the patient walking at approximately 2-3 miles per hour on a standard, motorized treadmill. The brace will reverse the abnormal posture according to the 3D posture analysis data. To facilitate tissue remodeling by reverse posture training, this called mirror image exercise.then the ambulatory exercises by using treadmill will be performed while the patient's mirror image posture will be held by the adjustable orthosis, ambulatory exercises for 20 minutes by using treadmill Based on Harrison et al and Hawes et al., approach, this program will be repeated 3 Times /week for 10 weeks.
15941393|NCT03331094|Procedure|Surgery with graft|arthrodesis with autologous bone graft and using pedicular ilio-sacred EUROS ® screw
15941394|NCT03331094|Procedure|surgery without graft|arthrodesis without bone graft using pedicular ilio-sacred EUROS ® screw
15941395|NCT03331081|Other|Bladder Training|The patient will participate in a class in which the physiotherapist will provide the following information: on the anatomy and function of the MAP, using figures; on bladder function; guidelines on the positioning and voiding habits and the definition and main risk factors responsible for urinary incontinence. The bladder training will consist of a program of time micturition to increase bladder capacity and the interval between urinations. Urge suppression strategies will be targeted, and include distraction, relaxation, breathing, and MAP contraction (quick flicks).
15941396|NCT03331081|Other|TMAP|There will be 36 monthly series of home training (totaling at the end of the 3 months of treatment 108 series) performed 3x / week, 3x / day. The training protocol consists of three daily TMAP series. One series consists of 8 maximum voluntary contractions, with maintenance of the contraction of 6 to 10 seconds (type I muscle fibers), with twice the rest time between contractions, followed by three to five rapid contractions (muscle fibers type II ). The protocol will total 24 contractions of MAP per day performed, which will be divided in the morning (8 contractions), late (8 contractions) and night (8 contractions).
15941397|NCT03331081|Other|Bladder Training + TMAP|Will perform the exercises of the bladder training group and the TMAP in an associated way.
15941398|NCT03331068|Behavioral|online questionnaire of MAX-PC|Scale measuring of the anxiety specific of prostate cancer, French version.
15941399|NCT03331055|Device|PENS|percutaneous electrical nerve stimulation
15941400|NCT03331055|Device|TENS|transcutaneous electrical nerve stimulation
15941401|NCT03331042|Drug|SM-1|3-drug combination product containing 50-mg diphenhydramine, 5-mg delayed-release zolpidem and 0.5-mg delayed-release lorazepam.
15941402|NCT03331042|Drug|D+Z|2-drug combination comparator product containing 50-mg diphenhydramine and 5-mg delayed-release zolpidem.
15941403|NCT03331042|Drug|D+L|2-drug combination comparator product containing 50-mg diphenhydramine and 0.5-mg delayed-release lorazepam.
15941404|NCT03331042|Drug|Placebo|Identical in appearance to SM-1, D+Z and D+L and has the same excipients, but no diphenhydramine, zolpidem, lorazepam or delayed-release coating materials.
15941405|NCT03331029|Device|transesophageal investigation|Comparison of 3D ultrasound with transesophageal echocardiography
15941406|NCT03331016|Behavioral|Heart to Heart Training|Training for foster and kinship caregivers on sexual health and how to effectively communicate with and monitor youth in their care, with the aim of reducing unintended pregnancies and sexually transmitted infections in this youth population.
15941407|NCT03331003|Device|low level light therapy|iRestore low-level light therapy on androgenetic alopecia
15941408|NCT03331003|Device|non-LLLT wavelength group|A LED light device is non-curative for the patients.
15941409|NCT03330990|Drug|Entrectinib|600 mg oral capsule (fasted and fed)
15941410|NCT03330990|Drug|Midazolam Hydrochloride|2 mg oral syrup (fasted)
15941411|NCT03330977|Device|Compression garments|"Patients will wear the compression garments since 4 months after inclusion in order to have a comparison before and after use.
~Usual practice would give to the patient the compression garments at inclusion."
15941412|NCT03330964|Other|electro-acupuncture|Electroacupuncture was administrated immediately after completion of oxaliplatin infusion,once a day for 3 days,30 minutes each time.
15941413|NCT03330938|Behavioral|CBI and Resilience|A combination of CBI techniques (Behavioural activation with positive reinforcement, Deep breathing and muscle relaxation, Cognitive restructuring) + Resilience strengthening (Identifying resilient strengths and potentialities, plus Imagination and projection into the future).
15941414|NCT03330938|Behavioral|Cognitive-behavioral Intervention|Only CBI techniques (Behavioural activation with positive reinforcement, Deep breathing and muscle relaxation, Cognitive restructuring).
15941415|NCT03330925|Device|ElastiMed's SACS|A wearable medical device that improve circulation using smart materials
15941416|NCT03330912|Device|Neutral seat height|Seat height set relative to participant's leg length with neutral set at the measured lower leg length
15941417|NCT03330912|Device|Very low seat height|"Seat height set relative to participant's leg length, 2 below the measured lower leg length"
15941418|NCT03330912|Device|Low seat height|"Seat height set relative to participant's leg length, 1 below the measured lower leg length"
15941419|NCT03330912|Device|Very high seat height|"Seat height set relative to participant's leg length, 2 above the measured lower leg length"
15941420|NCT03330912|Device|High seat height|"Seat height set relative to participant's leg length, 1 above the measured lower leg length"
15941421|NCT03330899|Biological|H7N9 antigen + adjuvant IB160|H7N9 monovalent (fragmented and inactivated)
15941422|NCT03330899|Biological|H7N9 antigen + adjuvant SE|H7N9 monovalent (fragmented and inactivated)
15941423|NCT03330899|Biological|H7N9 antigen without adjuvant|H7N9 monovalent (fragmented and inactivated)
15941424|NCT03330899|Biological|Placebo (PBS)|Placebo (Phosphate Buffered Saline -PBS)
15941425|NCT03330886|Drug|Atezolizumab|Atezolizumab will be administered via IV at a 1200-mg dose over 60 minutes every 3 weeks (to be reduced to 30 minutes every 3 weeks if the first dose is tolerated).
15941426|NCT03330873|Device|disposable balloon uterine stent|The disposable balloon uterine stent is heart-shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to Foley catheter
15941427|NCT03330873|Device|Foley catheter|Foley catheter can partly separate the sides of uterus wall.
15941428|NCT03330860|Other|Twelve clips regarding maternal and neonatal health topics|Twelve clips regarding maternal and neonatal health topics, designed with mixed 2D and 3D elements, each one about 45 seconds long (prepared based on the best available evidence and validated by clinical experts).
15941429|NCT03330860|Other|Control Clip|Control clip with 2D elements about 45 seconds long, containing information on prenatal control and presented in conventional format (narration, static images and on screen text).
15941430|NCT03330847|Drug|Olaparib Continuous (28-Day cycle) 300 mg BD.|Two (2) 150 mg olaparib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water (approximately 250 mL).
15941431|NCT03330847|Drug|Ceralasertib 160 mg OD + olaparib continuous 300 mg BD (28-day cycle).|Patients will be administered Ceralasertib OD at 160 mg from Day 1 to Day 7 (inclusive) of every 28-day cycle.
15941432|NCT03330847|Drug|Adavosertib 150 mg BD + olaparib 200 mg BD (21-day cycle).|Patients will be administered adavosertib BD at 150mg from Day 1 to Day 3 and Day 8 to Day 10.
15941433|NCT03330834|Biological|CAR-T cells to treat advanced lung cancer|"Drug: fludarabine. On days -4 through -2, fludarabine (25mg/m2) will be infused for 3 consecutive days; Drug: cyclophosphamide. On days -4 through -2, cyclophosphamide (250mg/m2) will be infused for 3 consecutive days.
~Patients will receive the above chemotherapy for lymphocyte-depletion followed by PD-L1 CAR-T cells."
15941439|NCT03330808|Other|Epidural anesthesia|After anesthesia induction, epidural catheter is inserted into lumbar epidural in epidural with general anesthesia group. A 10 ml of 0.2% ropivacaine should be given in epidural space via a catheter when anastomosis of free flap is finished in epidural with general anesthesia group.
15941440|NCT03330795|Biological|CD3/CD19 neg allogeneic BMT|Negative selection for CD3/CD19 will be performed on a CliniMACS® depletion device within 36 hours of collection and given at time no less than 8 weeks post lung transplant.
15941441|NCT03330782|Drug|Remifentanil|Remifentanil was infused at predetermined effect-site concentration prior to propofol infusion (initial concentration: 3.0 ng/ml) in elderly patients (65-80 years)
15941442|NCT03330782|Drug|Remifentanil|Remifentanil was infused at predetermined effect-site concentration prior to propofol infusion (initial concentration: 3.0 ng/ml) in adult patients (20-60 years)
15941443|NCT03330769|Drug|New course of treatment|Prescription of new course of NSAIDs (monotherapy), steroid intra-articular injections (monotherapy), conventional DMARDs, biologic DMARDs, including switches or dose augmentations, indicated by the treating rheumatologist according to usual clinical practice.
15941444|NCT03330756|Procedure|laparoscopic Roux-en-Y gastric bypass|laparoscopic Roux-en-Y gastric bypass with a 50 cm biliary limb and a 150 cm alimentary limb
15941445|NCT03330756|Procedure|laparoscopic Mini gastric bypass|laparoscopic Mini gastric bypass with a gastrojejunostomy at 200 centimeters measured from the ligament of Treitz
15941446|NCT03330743|Behavioral|Parent Mentor with Standard Education|Parent mentors will provide coaching based on the current guidelines around diet and physical activity
15941447|NCT03330743|Behavioral|Parent Mentor with Positive Deviance|Parent mentors will provide coaching based on findings from the positive deviance study
15941448|NCT03330730|Other|IsereADOM service package|Objects connected to patients' homes (thermometer, weight scale, tensiometer +/- oximeter, glucose meter or pedometer), Digital liaison booklet, Sentinel referent, Motivational coaching
15941449|NCT03330717|Procedure|General anesthesia|Patients will undergo oncologic breast surgery on general anesthesia.
15941450|NCT03330717|Procedure|Hypnosis sedation|Patients will undergo oncologic breast surgery on hypnosis sedation.
15941451|NCT03330717|Procedure|General anesthesia with preoperative session of hypnosis|Patients will undergo surgery on general anesthesia but will have a preoperative session of hypnosis relaxation.
15941452|NCT03330704|Drug|3% Sodium Chloride|3% sodium chloride will be infused into patients for the treatment or prevention of raised intracranial pressure
15941453|NCT03330704|Drug|23.4% Sodium Chloride|23.4% sodium chloride will be infused into patients for the treatment or prevention of raised intracranial pressure
15941454|NCT03330704|Drug|8.4% Sodium Bicarbonate|8.4% sodium bicarbonate will be infused into patients for the treatment or prevention of raised intracranial pressure
15941455|NCT03330691|Biological|Patient-derived CD19- and CD22 specific CAR|Patient-derived CD19-specific CAR also expressing an HER2t and CD22-specific CAR T-cells also expressing an EGFRt
15941456|NCT03330678|Dietary Supplement|Probiotic (VSL#3)|Each subject provided morning stool and venous blood ubes) specimens at three time-points, i.e. at baseline (before probiotic administration), after probiotic administration (VSL#3®, one capsule twice a day) for 4 weeks, and at 4 weeks after stopping the probiotic intake. Each capsule contained approximately 112.5 billion live freeze-dried bacteria (a mixture of eight species -- Streptococcus thermophilus, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, and Lactobacillus delbrueckii), which had been stored at 2-4ºC till ingestion.
15941457|NCT03330665|Behavioral|Meditation|Meditate 3 times a week using headspace app
15941458|NCT03330639|Other|Capsaicin|Capsaicin is a homeopathic medication and there for this drug is not subject to the requirements of the FDA.
15941459|NCT03330639|Other|Placebo|This group will receive the saline placebo solution.
15941460|NCT03330626|Device|InBody group|As one of representative BIVA, it provides the patients' fluid status with more objective data such as TBW, ECW, ICW, etc.
15941461|NCT03330626|Other|IO group|Fluid removal are guided by intake-output balance.
15941462|NCT03330613|Diagnostic Test|PAEDS|pediatric emergency delirium scale
15941463|NCT03330613|Procedure|TIVA|Total intravenous anesthesia with propofol
15941464|NCT03330613|Procedure|Inhalational anesthesia|Inhalational (volatile) anesthesia with sevoflurane
15941465|NCT03330600|Behavioral|aquatic physicotherapy|Aquatic physiotherapy will be performed in a bathtub with water heated to a temperature around 37º C and environment with adequate temperature and luminosity. Kinesiotherapy will begin with smooth sliding movements in the aquatic environment, still in flexor restraint, allowing the child to adapt to the temperature of the new environment; joint mobilizations will be initiated on the shoulders and hips followed by stretching of the accessory muscles of the breath, spine erector, flexor and extensors of shoulder, elbow, hip, knee and ankle. The sessions will last 10 minutes and may be interrupted if the child shows signs of discomfort such as cyanosis, increased respiratory rate, bronchoaspiration or does not adapt to the environment, ie, remain crying for more than 5 minutes.
15941466|NCT03330600|Behavioral|immersion|The immersion will be performed in a bathtub with water heated to a temperature around 37º C and environment with adequate temperature and luminosity. The therapy will begin with smooth sliding movements in the aquatic environment, still in flexor restraint, allowing the child to adapt to the temperature of the new environment. The sessions will last 10 minutes and may be interrupted if the child shows signs of discomfort such as cyanosis, increased respiratory rate, bronchoaspiration or does not adapt to the environment, ie, remain crying for more than 5 minutes.
15941467|NCT03330561|Drug|PRS-343|PRS-343
15941468|NCT03330548|Behavioral|TeleMOVE!|Active comparator- telehealth treatment program for weight management and health promotion
15941469|NCT03330548|Behavioral|Culinary Rx|Experimental Arm- An online instructional cooking and nutrition course to promote a whole-foods, plant-based lifestyle.
15941470|NCT03330535|Behavioral|Reminders once a week|Participants in this group will receive active oral hygiene reminders through text messaging once a week.
15941471|NCT03330535|Behavioral|Verbal oral hygiene instructions|Participants in this group will receive verbal oral hygiene instructions during their regular orthodontic visits every 4 weeks.
15941472|NCT03330535|Behavioral|Reminders three times a week|Participants in this group will receive active oral hygiene reminders through text messaging three times a week.
15941473|NCT03330535|Behavioral|Daily reminders|Participants in this group will receive active oral hygiene reminders through text messaging on a daily basis.
15941474|NCT03330522|Other|Love, Sex, & Choices video series|Love, Sex, and Choices was written and scripted by the study team and underwent pilot testing in the target population. The series was divided into 15-to-20 minute episodes that were streamed weekly. The principles of reducing HIV risk were communicated through the characters and high risk situations. The lead characters model how women become more powerful, meaning more aware of themselves as worthy of respect, making choices intentionally, feeling free to pursue their intentions, and involving themselves in creating change. This process leads to higher power sex scripts in the characters, meaning pursuing intentional choices and health promoting behaviors. The lead characters model open communication about HIV testing with a resistant partner, and initiating condom use.
15941475|NCT03330522|Other|Messages in text|"The comparison group received 12 weekly HIV health promotion written messages over the smartphone. The messages were based on prevailing CDC recommendations and the theoretical framework. An example is: Sexual health means respecting your own rights and feelings. Feeling pressured to have sex means limiting your choices and your freedom to love safely. …. If he doesn't like you being you, it may be time to walk. Other messages provided instructions on the correct condom use and the importance of HIV testing. The 12 messages were reviewed by ten African American and Latina undergraduate nursing students for ease of comprehension."
15941476|NCT03330509|Other|SPARK intervention|An integrated model of care (SPARK care) in which the palliative care team co-rounds with the medical oncology team, supporting them in their delivery of basic palliative care, seamlessly stepping in and out to deliver specialist palliative care directly to patients when needed.
15941477|NCT03330496|Other|Pain Measurement|Measurement of infant responses (behavioral and physiological) during a painful procedure.
15941478|NCT03330470|Behavioral|exercise|participants will be subjected to 3 months supervised exercise intervention
15941479|NCT03330470|Dietary Supplement|carnosine supplementation|participants will be instructed to take carnosine 2 times daily
15941480|NCT03330470|Behavioral|stretching|participants will be subjected to 3 months supervised stretching program
15941481|NCT03330470|Dietary Supplement|supplementation with placebo|participants will be instructed to take placebo 2 times daily
15941482|NCT03330457|Biological|Andexanet alfa (bolus)|fXa inhibitor antidote
15941485|NCT03330444|Procedure|Endometrial biopsy and endometrial fluid collection|On the same day that the EB for ERA is indicated, in day 5 of a HRT cycle with 5 days of progesterone, according to the common clinical practice, a sample of EF will be aspirated immediately prior to EB for ERA. This EF sample will be used for the non-invasive diagnosis of the microbiome, also a small portion of the endometrial tissue obtained for the endometrial receptivity diagnosis by ERA will be used as a control for the study of the endometrial microbiome. Those patients with a receptive endometrium will continue their ART according to the standard clinical protocol. Those patients with non-receptive endometrium will follow the recommendation derived of the ERA test for the election of the day for a second EB sample, in which the collection of EF sample will be repeated. Finally, the receptivity and microbiome results in EF will be correlated with that on the endometrial tissue, and with the reproductive outcomes of these patients after the embryo transfer.
15941486|NCT03330431|Behavioral|Progressive Muscle Relaxation (PMR)|"All groups undergo a PMR session, but they differ regarding the treatment before the PMR session. Two groups watch a video before undergoing PMR, the control group reads a text before undergoing PMR.
~Progressive muscle relaxation (PMR) is a technique for learning to monitor and control the state of muscular tension. It was developed by American physician Edmund Jacobson in the early 1920s.
~The technique involves learning to monitor tension in each specific muscle group in the body by deliberately inducing tension in each group. This tension is then released, with attention paid to the contrast between tension and relaxation."
15941487|NCT03330418|Biological|Placebo|Starting with the forty-ninth dose,the trial went into the open phase. All participants were treated with the test drugs.
15941488|NCT03330418|Biological|RC18 160 mg|In the Phase B,the researchers can adjust the dose of RC18 according to the subjects' willingness and recurrence, but the maximum dose of single dose should not exceed 320g.
15941489|NCT03330405|Drug|Avelumab Phase 1b|Avelumab
15941490|NCT03330405|Drug|Talazoparib Phase 1b|Talazoparib
15941491|NCT03330405|Drug|Avelumab Phase 2|The dose will be determined after the overall available data (including safety and preliminary anti tumor activity) emerging from the Phase 1b portion of the study have been evaluated.
15941492|NCT03330405|Drug|Talazoparib Phase 2|The dose will be determined after the overall available data (including safety and preliminary anti tumor activity) emerging from the Phase 1b portion of the study have been evaluated.
15941493|NCT03330392|Dietary Supplement|AGP|take two tablets per day (500 mg/day) for 8 weeks
15941494|NCT03330392|Dietary Supplement|Placebo|take two tablets per day (500 mg/day) for 8 weeks
15941495|NCT03330379|Device|Tracoe Smart CuffmanagerTM|In patients randomly assigned to the continuous adjustment strategy, in addition to standard care, the Tracoe Smart CuffmanagerTM will be connected to the tracheal cuff. Within the 2 days following the inclusion, all the intermittent Pcuff measurements will be collected as well as the incidence of Pcuff manual adjustments
15941496|NCT03330366|Dietary Supplement|Allium hookeri extract|take two capsules per day (486 mg/day) for 8 weeks
15941497|NCT03330366|Dietary Supplement|Placebo|take two capsules per day
15941498|NCT03330353|Diagnostic Test|Pupillometry|Use of pupillometry to assess melanopsin-light pathway in patients with neurodegenerative diseases
15941499|NCT03330340|Procedure|Percutaneous Vertebroplasty|The procedure takes place under sterile conditions. Local anesthesia is administered from skin to the periosteum of the targeted pedicle. Polymethylmethacrylate bone cement (Mendec Spine; Tecres SPA, Sommacampagna, Italy) is injected under continuous fluoroscopic imaging guidance using 1.0 ml syringes and 13 Gauge bone biopsy needles by bilateral procedures. The amount of injected cement in each treated vertebral body and any cement leakage is recorded.
15941500|NCT03330327|Biological|HM12470|HM12470 is a long-acting insulin analogue
15941501|NCT03330314|Biological|HM12460A|HM12460A is a long-acting insulin
15941502|NCT03330301|Other|D-tect|"This study is based on a unique Danish social experiment that took place during a well-defined period between 1937 and December 1985, when it was mandatory to fortify all margarine with vitamin D (1.25 μg/100 g). This well-defined vitamin D fortification period makes it possible to investigate the impact of fetal exposure to extra vitamin D from food fortification on the risk of developing diseases later on. This study is possible due not only to the well-defined adjacent time window but also to the complete registration of every citizen via a civil registration number. This number can be linked, on an individual level, to Danish birth, patient and medical registries; social and ethnic registries; and clinical and other large databases
~Case-cohort study: vitamin D measurements from dried blood spots and the risk of diseases later on"
15941503|NCT03330288|Drug|Theraflex, BAY 874017|The first three weeks which do have a different posology (3 capsules a day) according to the label should be entered as a distinct period to the treatment period with a recommended posology of 2 capsules a day
15941504|NCT03330275|Device|Investigational Contact Lens|JJVC senofilcon A-based contact lens with new UV-blocker
15941505|NCT03330275|Device|Commercial ACUVUE OASYS|senofilcon A
15941506|NCT03330275|Device|Commercial ACUVUE OASYS and Spectacles|Senofilcon A and Spectacles
15941507|NCT03330262|Device|BALCAP prosthesis|The noninvasive BALCAP prosthesis offers uses six degrees-of-freedom (6-DOF) sensing to detect postural imbalance and actuate low-amplitude vibrotactile cues directly to the head to provide the wearer with feedback concerning head tilt in the pitch and roll plane.
15941508|NCT03330249|Drug|Split Cisplatin|25 mg/m2/day IV infusion at D1 to D4, at D22 to D25, at D43 to D46 during the radiotherapy.
15941509|NCT03330249|Drug|Cisplatin|100 mg/m2/day IV infusion at D1, D22 and D43 during the radiotherapy.
15941510|NCT03330249|Radiation|Radiotherapy|70 Gy in 35 fractions of 2 Gy in non-operated patients and 66 Gy in 33 fractions in post-operative.
15941511|NCT03330236|Device|"Anesthetic depth management"|The propofol and remifentanil infusion rates will be adjusted to maintain the spectral edge frequency (SEF) value at 10-15 and the patient state index (PSI) value at 25-50 based on the SedLine EEG Brain Function Monitoring.
15941512|NCT03330223|Device|Clopidogrel group;Ticagrelor group|A total of 60 patients with ESRD and under dual-antiplatelet treatmen for at least 5 days will be enrolled and divided into the Clopidogrel group (clopidogrel 75mg qd;aspirin 100mg qd, n=30) and the Ticagrelor group (ticagrelor 90mg bid; aspirin 100mg qd, n=30). All included patients will receive haemodialysis by two different types of dialysis membrane.Platelet aggregation of venous blood from all patients will be detected by LTA and VerifyNow immediately before and after haemodialysis.
15941513|NCT03330210|Procedure|3D printing|Manufacturing and use of a model printed in 3D
15941514|NCT03330197|Biological|Ad-RTS-hIL-12|2.0 x 10^11 viral particles (vp) per injection, one intratumoral injection of Ad-RTS-hIL-12
15941515|NCT03330197|Drug|Oral Veledimex - Arm 1 (Pediatric Brain Tumor)|1 dose level (10mg/day) 15 oral daily doses of veledimex
15941516|NCT03330197|Drug|Oral Veledimex - Arm 2 (DIPG)|2 dose levels (10mg/day, 20mg/day) 14 oral daily doses of veledimex
15941517|NCT03330184|Drug|Berberine Hydrochloride group|
15941518|NCT03330184|Drug|Bifidobacterium group|
15941519|NCT03330184|Drug|Berberine Hydrochloride and Bifidobacterium group|
15941520|NCT03330184|Drug|placebo|
15941521|NCT03330171|Biological|Measles vaccine|All participants will receive measles vaccine at 6 and 12 months of age, according to the South African immunization schedule. All study vaccines are currently licensed in South Africa and will be administered according to their approved dosages, formulations and indications.
15941522|NCT03330171|Biological|Hepatitis-A vaccine|Half of the participants (n=135) will receive hepatitis-A vaccine at 18 months of age.
15941523|NCT03330171|Biological|Varicella vaccine|Half of the participants (n=135) will receive varicella vaccine at 18 months of age.
15941524|NCT03330158|Device|ASTS|Implantation of a motorized spinal distraction rod
15941525|NCT03330145|Behavioral|Scales, questionnaires and inventory|Children will complete scales, questionnaires and inventory at 3 months post-loss and only 2 scales at 6 and 12 month post-loss
15941526|NCT03330132|Biological|Standard inactivated influenza vaccine (NH formulation)|0.5mL FluQuadri®, Sanofi Pasteur, containing 60μg antigen - 15μg for each influenza strain included - with strains recommended by the WHO for the northern hemisphere formulation.
15941527|NCT03330132|Biological|MF 59 adjuvanted inactivated influenza vaccine (NH formulation)|0.5mL FLUAD(TM), Seqirus containing 45μg antigen; 15μg for each influenza strain included and MF59C.1 adjuvant (MF59®) with strains recommended by the WHO for the northern hemisphere formulation.
15941528|NCT03330132|Biological|High-dose inactivated influenza vaccine (NH formulation)|0.5mL Fluzone® High-Dose, Sanofi Pasteur containing 180μg antigen; 60μg for each influenza strain included with strains recommended by the WHO for the northern hemisphere formulation.
15941529|NCT03330132|Biological|Recombinant hemagglutinin inactivated influenza vaccine (NH formulation)|0.5mL Flublok®, Protein Sciences Corporation containing 180μg antigen, 45μg for each influenza strain included with strains recommended by the WHO for the northern hemisphere formulation.
15941530|NCT03330119|Drug|Alternate Management|With the alternate management protocol, the pre-operative order set is the same, with the addition of a single preoperative dose of acetaminophen 1 g IV x1, gabapentin 600 mg PO x1, and ondansetron 8 mg IV x1. Post-operatively, patients receive the same ketorolac 30mg x 9 doses every 6 hours, as well as acetaminophen 975 mg every 6 hours, both given standing. These two are timed so the patient is receiving one of the two medications every 3 hours during their inpatient stay. After 9 doses of ketorolac, the patient receives 600mg of ibuprofen PO, also given standing, instead of the ketorolac. If the patient requires narcotics, they may receive them on an as needed basis. IV fluids are running at 80 cc/ hour. Patients are encouraged to ambulate, including the evening of the surgery, have their foley catheter removed 12 hours post-operatively, and can have a regular diet immediately.
15941531|NCT03330119|Drug|Control|The regular Lankenau cesarean section order set includes routine vital signs, labs, IV fluids, and fetal heart monitoring. Post standard cesarean section orders include IV fluids running at 125 cc/ hour, along with routine post-partum care. In terms of pain control, most patients receive 9 doses of 30mg of IV ketorolac every 6 hours, along with hydromorphone, oxycodone/acetaminophen, or a hydromorphone PCA, per patient or attending request.
15941532|NCT03330106|Drug|Pevonedistat|Pevonedistat intravenous infusion.
15941533|NCT03330106|Drug|Docetaxel|Docetaxel intravenous infusion.
15941534|NCT03330106|Drug|Carboplatin|Carboplatin intravenous infusion.
15941535|NCT03330106|Drug|Paclitaxel|Paclitaxel intravenous infusion.
15941536|NCT03330093|Behavioral|Sleep Health in Preschoolers|In-person, family-based behavioral intervention
15941537|NCT03330093|Behavioral|Health and Safety Intervention|In-person, family-based behavioral intervention
15941538|NCT03330067|Device|Cold and dry CO2 pneumoperitoneum|In this arm, patients undergo pneumoperitoneum by the insufflation of cold (19-21°C) and nonhumidified (0%) CO2.
15941539|NCT03330067|Device|Warm and humidified CO2 pneumoperitoneum|In this arm, patients undergo pneumoperitoneum by the insufflation of warmed (95° F) and humidified (95% relative humidity) CO2, using a Lexion Insuflow device.
15941540|NCT03330054|Device|fundoscope|Fundoscope for eye examination
15941541|NCT03330041|Device|Fast absorbing gut suture|Fast absorbing surgical gut suture is a strand of collagenous material
15941542|NCT03330028|Drug|Dexamethasone|10 mg by vein approximately 60 minutes before Paclitaxel.
15941543|NCT03330028|Drug|Diphenhydramine|50 mg by vein approximately 60 minutes before Paclitaxel.
15941544|NCT03330028|Drug|Famotidine|20 mg by vein approximately 60 minutes before Paclitaxel.
15941545|NCT03330028|Drug|Mitomycin C|Mitomycin C 30 mg in 3-7 liters of infusate administered using a rolling pump with hyperthermia for approximately 60 minutes through 3 to 4 small incisions in abdomen.
15941546|NCT03330028|Drug|Cisplatin|Cisplatin 200 mg in 3-7 liters of infusate administered using a rolling pump with hyperthermia for approximately 60 minutes through 3 to 4 small incisions in abdomen.
15941547|NCT03330028|Drug|Paclitaxel|"Starting dose of Paclitaxel is 20 mg/m2 in 3-7 liters of infusate administered using a rolling pump with hyperthermia for approximately 60 minutes through 3 to 4 small incisions in abdomen.
~Dose-escalation scheme of Paclitaxel is in increments of 5 mg/m2."
15941548|NCT03330002|Device|CE-marked MANTA vascular closure device (VCD)|Compile real word data on MANTA VCD.
15941549|NCT03329989|Biological|Collagenase Clostridium Histolyticum|During 3 treatment visits 12 injections will be given per treatment area
15941550|NCT03329976|Other|measurement of visual acuity|complete ophthalmologic examination of a macular SD-OCT, a fundus of eye, evaluation of the vision of contrasts (Pelli-Robson test) and quantification of metamorphopsies (M-Charts);
15941551|NCT03329963|Behavioral|Healthy Lifestyle Intervention|Participants in the this group will receive group educational sessions that focus on diet, exercise, and social support once a month throughout the study. The sessions will provide an opportunity for participants to discuss issues related to living with obesity and aging.Participants will also attend regular scheduled clinic visits for assessment of outcomes.
15941552|NCT03329963|Behavioral|Lifestyle Intervention|"The lifestyle modification will be achieved by group behavior therapy sessions designed to have older adults acquire positive weight-control skills/attitudes, and practice weight-maintenance skills.Participants will attend weekly group sessions (10-15 persons), which will last ~75-90 minutes. Visit frequency will be decreased to every 2 wks. from 6 to 12 mos. to prevent treatment fatigue. A balanced diet will be prescribed to provide a deficit of 500-750 kcal/day from daily energy requirement.
~The exercise sessions are of ~90 min duration (~15 min warm-up of flexibility exercise, followed by ~30 min of aerobic exercise, and after a brief rest period, ~30 min of resistance training, and finally ~15 min balance exercise) conducted three times weekly supervised at our exercise facility for one year. Aerobic exercises consist of treadmill, stationary cycling, and stair climbing."
15941553|NCT03329950|Drug|CDX-1140|CDX-1140 will be administered every 4 weeks in Parts 1, 2 and 4, and every 3 weeks in Part 3.
15941554|NCT03329950|Drug|CDX-301|CDX-301 will be injected once a day for five days before Cycles 1 and 2.
15941555|NCT03329950|Drug|Pembrolizumab|Pembrolizumab will be administered every 3 weeks.
15941556|NCT03329950|Drug|Chemotherapy|Gemcitabine and Nab-paclitaxel will be administered on Day 1, Day 8 and Day 15 of each 4 week Cycle.
15941557|NCT03329937|Drug|Niraparib|Niraparib is a potent, orally active, highly selective poly adenosine diphosphate ([ADP]-ribose) polymerase 1 (PARP1) and PARP2 inhibitor. It will be supplied as 100 mg capsules and will be administered at starting dose of 200 mg PO daily throughout 28 days for 2 cycles (each cycle is 28 days), with the potential for an additional 4 cycles (maximum total of 6 cycles) at the assigned dose and schedule.
15941558|NCT03329924|Other|Activity level measurement by accelerometer|Eligible patients will wear an accelerometer to measure activity levels while in the ICU.
15941559|NCT03329911|Drug|EU Avastin®|100 mg/4 mL
15941560|NCT03329911|Drug|BAT1706|100 mg/4 mL
15941561|NCT03329911|Drug|Paclitaxel|200 mg/m²
15941562|NCT03329911|Drug|carboplatin|target area under the curve [AUC] 6 mg/mL•minute
15941563|NCT03329898|Procedure|dried biological amnion graft|dried biological amnion graft. The amnion grafts were spread on the balloon end of disposable balloon uterine stent .
15941564|NCT03329898|Device|disposable balloon uterine stent|the disposable balloon uterine stent is heart-shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus.
15941565|NCT03329898|Drug|estradiol valerate tablets|oral estradiol valerate tablets, which can promote endometrial growth after operation.
15941566|NCT03329898|Drug|dydrogesterone Tablets|oral dydrogesterone Tablets
15941567|NCT03329885|Drug|BMS-986251|Escalating oral dose
15941568|NCT03329885|Other|Placebo|Escalating oral dose
15941569|NCT03329872|Other|Data collection|data collection about symptoms without any specific clinical or biological intervention
15941570|NCT03329859|Procedure|High resolution standardized laparoscopic cholecystectomy|High resolution standardized laparoscopic cholecystectomy
15941571|NCT03329846|Drug|BMS-986205|specified dose on specified day
15941572|NCT03329846|Biological|Nivolumab|Specified dose on specified day
15941573|NCT03329846|Drug|Placebo|Specified dose on specified day
15941574|NCT03329833|Behavioral|Motivational Interviewing|Motivational interviewing will consist of weekly phone calls for two months, bi-weekly phone calls for two months, and monthly phone calls for two months.
15941575|NCT03329833|Behavioral|Web-based application|Web-based application participants will be asked to log activity at least on a daily basis.
15941576|NCT03329807|Device|Transcranial Magnetic Stimulation|The subjects were seated in a comfortable chair with head and arm rests. Focal TMS of the somatosensory cortex was performed with a 70-mm figure-8 coil attached to magnetic stimulator stimulation parameters : frequency of 10Hz on the injured hemisphere by stroke; 1500 pulses with an intensity of 120% of MT 10 sessions of rTMS, one per day, always before conventional sensory therapy. rTMS it will be applied for about 20 minutes, five days per week.
15941577|NCT03329807|Behavioral|conventional sensory therapy|Behavioral: conventional sensory therapy All patients will receive the same protocol of Sensory Therapy that will consist of the behavioral methods of Active Sensory Reeducation, Mirror Therapy and passive method that will consist in the administration of electric current by TENS (sensitive threshold). Participants will be instructed not to perform active muscular contraction during Interventions. The protocol it will be applied for about 60 minutes, five days per week.
15941578|NCT03329781|Dietary Supplement|BCM-95|Consuming 1 capsule of BCM-95 per day.
15941579|NCT03329781|Dietary Supplement|Placebo|Consuming 1 placebo capsule per day
15941580|NCT03329755|Other|Dedicated and coordinated e-follow-up during the treatment period|"Completion of questionnaires using an electronic tool
~Telephone follow-up between the nurse and the patient
~Completion of the Quality of Life Questionnaire Core 30 (QLQ-C30)"
15941581|NCT03329755|Other|Standard follow-up during the treatment period|- Completion of the Quality of Life Questionnaire Core 30 (QLQ-C30)
15941582|NCT03329742|Other|Low protein diet|Patients on this arm will receive a prescribed diet (including all food and recommendations for beverages) that contains 10% protein to begin eating 1 week prior to treatment with sipuleucel-T and throughout treatment (i.e. diet will last approximately 49 days).
15941583|NCT03329742|Other|Control protein diet|Patients on this arm will receive a prescribed diet (including all food and recommendations for beverages) that contains 20% protein to begin eating 1 week prior to treatment with sipuleucel-T and throughout treatment (i.e. diet will last approximately 49 days).
15941584|NCT03329729|Other|Rosuvastatin|Hyperlipidemic patients treated with rosuvastatin
15941585|NCT03329716|Other|Brace weaning|For AIS patients who have been wearing Boston brace and attend clinic consultation where the decision for brace weaning is made, then weaning protocol of either arm will be prescribed
15941586|NCT03329703|Behavioral|Project UPLIFT|A group, telephone-based intervention for depression that uses techniques from mindfulness-based therapy and cognitive therapy. The intervention consists of 8 sessions occurring at the same time and day every week.
15941587|NCT03329690|Drug|DS-8201a|DS-8201a is comprised of an antibody component conjoined to a drug component in a lyophilized powder, which is made into solution for intravenous administration.
15941588|NCT03329690|Drug|Physician's Choice|"Either:
~Irinotecan monotherapy (Starting dosage and usage is 150 mg/m2 biweekly, with dose reduction permitted)
~Paclitaxel monotherapy (Starting dosage and usage is 80 mg/m2 weekly, with dose reduction permitted)"
15941589|NCT03329677|Other|Transference-focused Psychotherapy (TFP)|Participants receive 18 months of bi-weekly TFP. Each sessions lasts 50 minutes. During sessions, a therapist employs assorted psychodynamic techniques tailored specially for symptoms and relational difficulties associated with BPD. A participant processes interpersonal experiences with her therapist in sessions alongside her therapist and gains therapeutic insight into her problematic ways of relating to her self and others.
15941590|NCT03329664|Biological|Cytokine-induced killer cell|Immune-cell therapy with CIK cells
15941591|NCT03329664|Other|Chemotherapy AND/OR Radiation Therapy|Routine treatments for colon cancer patients according to their stage
15941592|NCT03329651|Drug|Metformin treatment|"Daily treatment with metformin tablets for 24 days according to the following scheme:
~Day 1-4: Metformin tablet 500 mg x 2 Day 5-8: Metformin tablet 1000 + 500 mg Day 9-24: Metformin tablet 1000 mg x 2"
15941593|NCT03329651|Drug|Placebo treatment|"Daily treatment with placebo tablets for 24 days according to the following scheme:
~Day 1-4: Placebo tablet 500 mg x 2 Day 5-8: Placebo tablet 1000 + 500 mg Day 9-24: Placebo tablet 1000 mg x 2"
15941594|NCT03329638|Drug|DE-127 Ophthalmic Solution low dose|Low dose of DE-127 Ophthalmic Solution dosed once daily for 12 months
15941595|NCT03329638|Drug|DE-127 Ophthalmic Solution medium dose|Medium dose of DE-127 Ophthalmic Solution dosed once daily for 12 months
15941596|NCT03329638|Drug|DE-127 Ophthalmic Solution high dose|High dose of DE-127 Ophthalmic Solution dosed once daily for 12 months
15941597|NCT03329638|Drug|Placebo Ophthalmic Solution|Placebo Ophthalmic Solution dosed once daily for 12 months
15941598|NCT03329625|Behavioral|Pathways Triple P|Pathways Triple was developed by Matt Sanders and is a behavioral parent training intervention designed to treat child behavior problems and prevent child maltreatment.
15941599|NCT03329625|Behavioral|Services as Usual|Families received family centered services and other parenting interventions as deemed appropriate by the child welfare case manager.
15941600|NCT03329612|Procedure|Remote Ischemic Preconditioning|Serial inflations and deflations as detailed in the arm/group descriptions.
15941601|NCT03329599|Drug|Polycap|Assigned to a polypill containing 2/3 antihypertensives, a moderate/high-intensity statin and Aspirin to be taken orally, once daily in the form of a hard capsule
15941602|NCT03329586|Other|High-intensity training|6-month individualized home- and group-based training program with the goal to cycle the Mont Ventoux in France
15941603|NCT03329573|Drug|Paroxetine IR tablets A|Paroxetine IR tablets A will be the investigational drug. These are film coated tablets with unit dose strength of 20 milligrams (mg) and will be administered via oral route. These tablets will be manufactured in GSKT.
15941604|NCT03329573|Drug|Paroxetine IR tablets B|Paroxetine IR tablets B will be the reference drug. These are film coated tablets with unit dose strength of 20 mg and will be administered via oral route. These tablets will be manufactured in Mississauga.
15941605|NCT03329560|Biological|Oral fecal microbiota transplantation|All subjects will receive one dose per week for 6 weeks (6 total doses) of PRIM-DJ2727 oral capsules containing lyophilized microbiota product derived from 150 grams of healthy donor stool.
15941606|NCT03329547|Drug|Cefixime test capsule|"SKF101804/cefixime test capsule will be given with a single dose of 400 mg administered orally along with 240 mL of water. It will be available as a dark purple head and off white body locking type capsule with GSK' printed on cap and 400MG printed on body of capsule."
15941607|NCT03329547|Drug|Cefixime reference capsule|"Cefixime reference capsule will be given with a single dose of 400 mg administered orally along with 240 mL of water. It will be available as red/orange hard gelatin size 0 capsule with Cefspan 400 mg printed on body of capsule."
15941608|NCT03329534|Other|Gluten free diet|A month long gluten free diet
15941609|NCT03329521|Other|Multi-component quality improvement intervention|Patients in 13 of the 26 CKD programs will receive a quality improvement intervention or usual care. The intervention has four main components: (1) local quality improvement teams and administrative support; (2) tailored education and resources for staff, patients, and living kidney donor candidates; (3) support from kidney transplant recipients and living kidney donors; and (4) program-level performance reports and oversight by program leaders.
15941610|NCT03329508|Drug|P2B001|Fixed dose once daily combination capsule of pramipexole and rasagiline
15941611|NCT03329508|Drug|Rasagiline|Rasagiline oral capsule
15941612|NCT03329508|Drug|Pramipexole|Pramipexole low dose oral capsule
15941613|NCT03329508|Drug|Pramipexole ER|Pramipexole ER titrated to optimal dose
15941614|NCT03329495|Procedure|SMA-orientated right hemicoloectomy|Laparoscopic right hemicoloectomy for right colon cancer with a medial-to-lateral approach orientated by SMA. The left boundary of resection is the left side of SMA, and artery sheath is not necessarily being opened.
15941615|NCT03329495|Procedure|SMV-orientated right hemicoloectomy|Laparoscopic right hemicoloectomy for right colon cancer with a medial-to-lateral approach orientated by SMV. The left boundary of resection is the left side of SMV, and SMA is not exposed.
15941616|NCT03329482|Other|PULSE ULTRASOUND|For group A, The PUS group received pulse mode of ultrasound (sonoplus 490s), with frequency of 1MHZ and intensity of 1.5w/cm according to Ebadi et al 10). Grey's formula was used to estimate the duration of ultrasound (US) for each patient 21). The average local exposure time was one minute and the effective radiating area of the transducer head was 5 cm2. For a patient with an area of low back pain of 40 cm2, the required total treatment time was: 1 min × (40 cm2/5 cm2) = 8 minutes. US was applied using slow circular movements, with the transducer head placed over the painful paravertebral low back region and Lofnac gel used as coupling medium.
15941617|NCT03329482|Other|KNEADING MASSAGE|Kneading massage was done with the two hands maintaining a slow circular compression of soft tissues against underlying bone. Pressure was applied as the hands moved proximally, continuously maintaining a contact with the skin, according to Goat22). Lofnac gel was used as a coupling medium for the massage. This was done for an approximately ten and 12 minutes.
15941618|NCT03329469|Device|Toshiba CT-FFR|Patients receiving CCTA to diagnose acute chest pain or unstable angina will receive CT-FFR to estimate rate of blood flow through the coronary arteries. The rate of flow will be compared to the rate found on Invasive FFR (the gold standard) if the subject receives invasive FFR.
15941619|NCT03329456|Drug|Ropivacaine|Minimum effective volume
15941620|NCT03329443|Drug|Spironolactone|each patient will receive 200 mg of spironolactone as per his/her angiography premedications
15941687|NCT03329040|Other|No Intervention.|No intervention.
15941621|NCT03329443|Drug|Placebo Oral Tablet|Each patient will receive a placebo tablet as per his/her angiography premedications
15941622|NCT03329430|Other|Foot orthoses|Customized foot orthoses
15941623|NCT03329417|Other|task-oriented training|Motor training targeted to goals that are relevant to the functional needs of the patient
15941624|NCT03329404|Device|Mirasol Red Blood Cells (MIR RBCs)|Mirasol Red Blood Cells (MIR RBCs) derived from Mirasol-treated WB; WB will be Mirasol treated, centfifuged and leukoreduced and the derived RBCs will be stored before transfusion for up to 21 days and transfused according to the patient's transfusion schedule.
15941625|NCT03329404|Device|Reference Red Blood Cells (REF RBCs)|Reference Red Blood Cells (REF RBCs) will be acquired from routine use inventory and transfused according to the patient's transfusion schedule.
15941626|NCT03329391|Behavioral|Nurse-led cognitive-behavioral-based group intervention|The intervention focused on the following topics of symptom awareness(i.e. provision of literacy in depression and stress), stress management, lifestyle restructuring and emotional self-care. These topics have been integrated as four major domains for discussions in the eight-weekly sessions. Each session starts with open discussion for participants' daily concerns to activate group dynamics, followed by second part of domain-oriented discussions, and then the third part of session review and homework reminder.
15941637|NCT03329352|Device|F&P Full-Face Mask|The F&P full-face mask will serve as the participant's primary PAP therapy mask for the duration of the trial period (from Visit 2 to Visit 3). For participants taking part in the study extension, they will be using the trial full-face mask as their primary PAP therapy mask for 6 months after Visit 3.
15941638|NCT03329339|Procedure|1 L PEG with ascorbic acid with prepackaged, low residue diet|Participants who were allocated to the 2 L PEG with ascorbic acid (PEGA) group took 250 ml of PEG with ascorbic acid at 15-min intervals, completing 1 L of the PEG with ascorbic acid protocol at 8:00 PM on the day prior to the procedure. The remaining 1 L of the PEG with ascorbic acid solution was administered in the same manner at 6:00 AM on the day of the procedure. Participants assigned to the 1 L PEG with ascorbic acid with PLD (PLD) group consumed a prepackaged, low residue diet (ZeroCol, Korea Medical Food Inc., Seoul, Korea) which consisted of a breakfast, lunch and dinner, the day prior to colonoscopy. The Participants took 1 L PEG with ascorbic acid solution at 6:00 AM on the day of the colonoscopy in the same way as described above. All of the subjects ingested 500 mL of water for every 1 L of 1 L PEG with ascorbic acid solution consumed. The Participants completed all of the administrations at least 2 hours before the colonoscopy.
15941639|NCT03329326|Other|Functional tests and self-reported questionnaires|In this observational study no intervention is initiated. Patients included are only assessed with the non-invasive tests described earlier.
15941640|NCT03329313|Drug|Lowering sodium concentration dialysate|Concentration of sodium in dialysate at 140 mmol/l
15941641|NCT03329313|Drug|Highing sodium concentration dialysate|Concentration of sodium in dialysate at 145 mmol/l
15941642|NCT03329300|Behavioral|Family-based Behavioral Treatment (FBT)|Family-based behavioral treatment (FBT) involves working with children and caregivers to modify diet and physical activity using behavioral strategies such as problem solving, goal setting, and self-monitoring. Children and caregivers will meet in group format on a weekly basis for 6 months. There will be 24 group session total, covering a variety of topics including nutrition, physical activity, and other aspects of health and wellness.
15941643|NCT03329287|Behavioral|SCBT|SCBT, one hour per session.
15941644|NCT03329287|Drug|SSRIs and/or SNRIs|SSRIs and/or SNRIs at a recommended dosage.
15941645|NCT03329287|Behavioral|Psychological Placebo|Supportive and relaxation therapy, one our per session.
15941646|NCT03329261|Drug|Clopidogrel|COPIGREL® - clopidogrel dosed at 75 mg per tablet
15941647|NCT03329248|Biological|ALT-803|Recombinant human super agonist interleukin-15 (IL-15) complex
15941648|NCT03329248|Biological|ETBX-011|Ad5 [E1-, E2b-]-CEA
15941649|NCT03329248|Biological|GI-4000|Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins
15941650|NCT03329248|Biological|haNK for infusion|NK-92 [CD16.158V, ER IL-2]
15941651|NCT03329248|Biological|avelumab|Recombinant human anti-PD-L1 IgG1 monoclonal antibody
15941652|NCT03329248|Biological|bevacizumab|Recombinant human anti-VEGF IgG1 monoclonal
15941653|NCT03329248|Drug|Capecitabine|5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine
15941654|NCT03329248|Drug|Cyclophosphamide|2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
15941655|NCT03329248|Drug|Fluorouracil|5-fluoro-2,4 (1H,3H)-pyrimidinedione
15941656|NCT03329248|Drug|Leucovorin|L-Glutamic acid, N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-, calcium salt
15941657|NCT03329248|Drug|nab-Paclitaxel|Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin
15941658|NCT03329248|Drug|lovaza|Omega-3-acid ethyl esters
15941659|NCT03329248|Drug|Oxaliplatin|cis-[(1 R,2 R)-1,2-cyclohexanediamine-N,N'] [oxalato(2-)- O,O'] platinum
15941660|NCT03329248|Procedure|SBRT|Stereotactic Body Radiation Therapy
15941661|NCT03329235|Drug|PRP|platelet rich plasma
15941662|NCT03329235|Drug|HA|hyaluronic acid
15941764|NCT03328507|Drug|PEG Control|Polyethylene glycol-based bowel preparation
15941663|NCT03329222|Other|Specific hydrolysed proteins|An infant formula which contains specific hydrolysed proteins with a fat blend, prebiotics mixture, starch and reduced lactose
15941664|NCT03329222|Other|Standard cow's milk with prebiotics mixture|Standard cow's milk with prebiotics mixture
15941665|NCT03329209|Drug|Vedolizumab|Vedolizumab intravenous infusion.
15941666|NCT03329196|Drug|MT-6548|Oral tablet
15941667|NCT03329196|Drug|Darbepoetin alfa|Subcutaneous
15941668|NCT03329183|Drug|Irinotecan|High-dose FOLFIRI regimen (Irinotecan 260mg/m2 2h, leucovorin 400mg/m2, 5- fluorouracil 400mg/m2 , 5- fluorouracil 2400 mg/m2 46h, 14 days per course)
15941669|NCT03329170|Behavioral|educational intervention using motivational interviewing|A dental hygienist will offer the families verbal and written information regarding oral health and its importance in children with CHD at the cardiac ward, when child is <12 months. At 6, 12 and 18 months of age, oral health behaviour is assessed via internet, the parents of the child will be sent written information regarding oral health, a tooth brush and a 1000ppm Fluoride tooth paste, after which the dental hygienist will call the parents of the child, to provide additional counselling regarding oral health and its importance in children with CHD. The counselling will be done by motivational interviewing. The themes discussed will be the parents' concerns regarding main points in the written information from the cardiac ward: oral home care, eating habits and dental contact.
15941670|NCT03329157|Other|Rebuilding Bridges|Psychosocial intervention to help veterans re-engage with family members called Rebuilding Bridges, developed for this project.
15941671|NCT03329144|Behavioral|Cognitive Behavioural Therapy|The transdiagnostic CBT-based curriculum is based on the extensive clinical experience of the research team with young women and those struggling with perinatal mental disorders. The team also has significant expertise delivering CBT for depression and anxiety (including perinatal variants) in groups. The manual was developed by the research team and is based on the state-of-the-art in resilience and CBT interventions in adolescents and young adults (e.g., the Penn Resiliency Program (60), Treatment for Adolescent Depression Study (61)). After it was developed, it was subjected to further scrutiny by public health nurses and STRIVE staff, who have extensive experience working with young mothers.
15941672|NCT03329131|Device|Cryotherapy|An Elasto gel™ frozen (4°C) glove and sock
15941673|NCT03329118|Drug|SHR3824, Simvastatin|two 20mg tablets of simvastatin once daily on Day 1 followed by one 10mg tablet of SHR3824 once daily on Day 4,5,6,7,followed by two 20mg tablets of simvastatin and one 10mg tablet of SHR3824 on Day 8.
15941674|NCT03329105|Other|Sea Salt Mouth Rinse|Rinsing mouth with a tablespoon of sea salt mouth rinse without any dilution, for 30 seconds, once in the morning and once before bed, in addition to Standardized Oral Health Practices.
15941675|NCT03329105|Other|Standardized Oral Health Practices|Brushing teeth for two minutes using the modified Bass technique, twice per day with the provided dentifrice, and flossing once daily using the spool method
15941680|NCT03329079|Behavioral|Mobile Technology Plus|The intervention group MT+ will receive the premium-version mobile phone app with social comparison group, behavior change text messaging, and daily self-weighing via Wi-Fi scale.
15941681|NCT03329079|Behavioral|Mobile Technology|The comparison group MT will receive the basic-version mobile phone app only to self monitor eating, activity, and weight.
15941682|NCT03329066|Behavioral|MAST - Managing Asthma & Sleep in Teens|This behavioral intervention will teach teenagers asthma self-care strategies and sleep hygiene.
15941683|NCT03329066|Behavioral|ASMA - Asthma Self-Management for Adol|This behavioral intervention focuses only on asthma care.
15941684|NCT03329066|Behavioral|Information & Referral Control Group|Students learn basic information about asthma and sleep, as well as other health topics relevant to teenagers.
15941685|NCT03329053|Behavioral|The EAPC Exercise Prescription (EXPERT) Tool|"During the 30-minute long consultation subjects will receive standard, usual-cardio-care lifestyle, hypertension and cardiovascular instructions, except recommendations for physical activities. This domain will be consulted exclusively through the digital training and decision support tool.
~The EXPERT tool is an interactive digital training and decision support system for optimized exercise prescription in cardiovascular disease patients. The EXPERT tool was designed to provide optimized exercise prescription based on detailed overview of patient´s diagnosis, prognostics, complications and medication."
15941686|NCT03329053|Behavioral|Standard Cardio-Care Lifestyle Counselling|During the 30-minute long consultation subjects will receive standard, usual-cardio-care lifestyle, hypertension and cardiovascular instructions also in the domain of recommendations for physical activities. The exercise prescription process during consultation will be constructed in accordance with published guidelines and recommendations for secondary prevention of cardiovascular diseases.
15941688|NCT03329027|Device|Vibrating Capsule|Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
15941689|NCT03329027|Device|Sham capsule|Patients will receive vibrating capsule for 8 weeks of treatment (5 capsules/week)
15941690|NCT03329014|Drug|Remimazolam|For induction and maintenance of sedation
15941691|NCT03329014|Drug|Placebo|Control arm
15941692|NCT03329001|Drug|Niraparib Tablet|Niraparib tablet formulation
15941693|NCT03329001|Drug|Niraparib Capsule|Niraparib capsule formulation
15941694|NCT03328988|Procedure|QLB|bilateral single shot block, placed under ultrasound control between the thoracolumbar fascial structures close to the quadratus lumborum muscle
15941695|NCT03328975|Drug|Dexamethasone|The overall purpose of this study is to evaluate the effect of a corticosteroid shoulder injection on glucose levels in insulin-dependent diabetic men and women.
15941696|NCT03328975|Other|Placebo|the placebo group will not receive the corticosteroid medication in their injection to treat the inflammation and pain in their shoulder. Instead, they will receive an injection of 5 mL lidocaine only.
15941697|NCT03328962|Behavioral|Structured smoking cessation counselling based on motivational interviewing (MI) and adapted for the cancer setting eventually combined with provision of smoking cessation medication|structured smoking cessation counselling based on MI and adapted for the cancer setting eventually combined with provision of smoking cessation medication
15941698|NCT03328949|Device|IVL Coronary Lithotripsy System|The coronary intravascular lithotripsy catheter is similar to other balloon devices that are routinely used during angioplasty procedures; however, it has electrodes inside the balloon which are designed to deliver energy to crack the calcified blockage using lithotripsy (acoustic energy).
15941699|NCT03328936|Other|Laboratory Biomarker Analysis|Correlative studies
15941700|NCT03328936|Drug|Melphalan Hydrochloride|Given personalized dose IV for predicted 3-day duration of severe neutropenia
15941701|NCT03328936|Drug|Melphalan Hydrochloride|Given personalized dose IV for predicted 5-day duration of severe neutropenia
15941702|NCT03328936|Other|Pharmacological Study|Correlative studies
15941703|NCT03328923|Dietary Supplement|500mg brown seaweed powder|
15941704|NCT03328923|Dietary Supplement|Placebo|
15941705|NCT03328910|Device|SPI monitor (GE Healthcare, Helsinki, Finland)|The SPI is derived from pulse rate and pulse wave amplitude measured with photoplethysmography, obtained from the CARESCAPE B650 monitor (GE Healthcare, Finland) with a scale from 1 to 100.
15941706|NCT03328897|Drug|Omalizumab|injection of 150mg or 300 mg
15941707|NCT03328897|Drug|Placebo|Injection of placebo
15941708|NCT03328884|Drug|Irinotecan Hydrochloride|"nal-IRI (nanoliposomal irinotecan, also known as MM-398 and PEP02) is irinotecan hydrochloride, (also known as CPT-11) a topoisomerase 1 inhibitor, encapsulated in a liposome drug delivery system.
~nal-IRI will be administered with a fixed dose of 60 mg/m2 on D1 of a 14-day cycle in monotherapy."
15941709|NCT03328871|Device|Fractional CO2 Laser|Fractional Carbon Dioxide Laser will be treated once every three months for 2 times.
15941710|NCT03328871|Procedure|Nanofat grafting|Nanofat grafting will be applied once every three months for 2 times.
15941711|NCT03328871|Procedure|Platelet-rich plasma (PRP) Injection|PRP Injection will be applied once a month for 6 times.
15941712|NCT03328858|Other|Ketogenic Diet|Once tolerance to the diet has been assessed, participants will be placed in the ketogenic diet, followed-up every three months until the one year completion.
15941713|NCT03328845|Drug|Toujeo SoloStar|
15941714|NCT03328845|Drug|Tresiba|
15941715|NCT03328845|Drug|Humalog Kwikpen|
15941716|NCT03328845|Drug|NovoRapid|
15941717|NCT03328845|Drug|Apidra|
15941718|NCT03328832|Drug|Topical tranexamic acid|Intraarticular application of tranexamic acid 3g in 60 ml normal saline into knee joint after closure of the joint capsule
15941719|NCT03328832|Drug|Floseal®|Floseal® (Hemostatic matrix, 10ml, Baxter) was applied on potential bleeding sites: the femoral insertion of the posterior cruciate ligament, the lateral genicular artery after resection of the meniscus, the posterior capsule of the knee joint, the bony surfaces not covered by the implant as well as the pinholes (femur and tibia). The entire content of a 10 mL vial containing the active product (Floseal®) was used. The HM remained in place for 3 minutes and was then gently rinsed from the knee as recommended by the manufacturer (Baxter)
15941720|NCT03328832|Drug|rivaroxaban (10mg)|Oral rivaroxaban (10mg) QD on PostOp Day 1 to 14.
15941721|NCT03328819|Other|Acupuncture|Acupuncture is a form of alternative medicine in which thin needles are inserted into the body. It is a key component of traditional Chinese medicine (TCM). TCM theory and practice are not based upon scientific knowledge, and acupuncture is a pseudoscience. There are a diverse range of acupuncture theories based on different philosophies, and techniques vary depending on the country. The method used in TCM is likely the most widespread in the US. It is most often used for pain relief, though it is also used for a wide range of other conditions.
15941722|NCT03328793|Behavioral|Mood Assessment|Prior to and after the session, the patients will be asked to fill a VAMS (Visual Analog Mood Scale).
15941723|NCT03328793|Behavioral|Emotion Assessment|During the sessions, the patients will be videotaped and the videotapes will be reviewed by 2 independent research assistants. With the use of the Observed Emotional Rating Scale (OERS), the research assistants will be able to assess the patients's emotions at the beginning and at the end of the session (they will analyse the first 10 and the last 10 minutes of the sessions).
15941724|NCT03328793|Behavioral|Communication Assessment|During the sessions, the patients will be videotaped and the videotapes will be reviewed by 2 independent research assistants. With the use of the CODEM Scale, the research assistants will be able to assess the patients's emotions at the beginning and at the end of the session (they will analyse the first 10 and the last 10 minutes of the sessions).
15941725|NCT03328793|Other|Mobility assessment|If deemed to be safe, the patients will undergo a gait speed assessment as well as a TUG (timed-up-and-go) prior to and after the sessions
15941726|NCT03328793|Other|Music Intervention|The participants will listen to a 30 minute live music sessions which will be given by musicians (who is a volunteer)
15941727|NCT03328793|Other|Documentary watching|The patients will watch a documentary for 30 minutes in the presence of a volunteer
15941728|NCT03328780|Device|Hemocue and Rad-67 measurement|Measurement of the hemoglobin level
15941765|NCT03328494|Drug|BOS172722|Oral capsules
15941729|NCT03328767|Behavioral|Early activity and Mobilisation intervention|The early activity and mobilisation intervention is comprised of exercises based on a reproducible, physiological approach using both strength and functional activities
15941730|NCT03328754|Device|Powerscope placed bilaterally for class II correction|Powerscope placed bilaterally for class II correction
15941731|NCT03328754|Device|Group 2 Forsus|Forsus placed bilaterally for class II correction
15941732|NCT03328741|Behavioral|Online Osteoarthritis treatment|6 week online-program
15941733|NCT03328741|Behavioral|Face-to-face osteoarthritis treatment|3 months face-to-face program
15941734|NCT03328728|Device|Cellular Matrix / A-CP HA Kit|Treatment with a single intra-articular injection in the knee of Cellular Matrix / A-CP HA Kit; Cellular Matrix / A-CP HA Kit is designed for the safe, rapid and extemporaneous preparation of a cellular matrix of autologous PRP combined with HA. The Cellular Matrix / A-CP HA Kit is a single-use medical device including hematology tubes (A-CP HA tube), designed for blood collection and PRP/HA preparation after 5 min centrifugation. This tube contains a non-crosslinked hyaluronic acid (MW 1550 kDa) solution, a gel acting as a cell separator, and a sodium citrate acting as an anticoagulant. During centrifugation, the separator gel moves to form a barrier that separates red blood cells from other blood components. The HA, which migrates to the top of the gradient during centrifugation, can be mixed with PRP in order to give rise to a ready-to-use PRP/HA preparation.
15941735|NCT03328728|Device|Synvisc-One|Treatment with a single intra-articular injection in the knee of Synvisc-One; Synvisc-One (hylan G-F 20) is a sterile, nonpyrogenic, elastoviscous fluid containing hylans. Hylans are derivatives of hyaluronans (sodium salt of hyaluronic acid). Hylan A has an average molecular weight of 6,000,000 daltons and hylan B is a hydrated gel. Hylan G-F 20 contains hylan A and hylan B (8.0 mg per ml) in buffered physiological sodium chloride solution.
15941736|NCT03328715|Device|intraoperative OCT|before and after surgery intraoperative OCT is performed
15941737|NCT03328715|Device|stand-alone OCT|before and after surgery stand-alone OCT is performed
15941738|NCT03328702|Device|Continuous Positive Airway Pressure|Apex XT Fit CPAP Machine
15941739|NCT03328689|Other|Physical activity program|This arm will begin with PT assessment. Following this, participants will meet with a specialist who will design an individualized physical activity program. Classes will include warm up, 40 minutes of individualized exercises and a cool down that will include back pain specific exercises including core strengthening. The first 4 weeks of exercise will include a 30-minute education program. Education comprise information on back pain, efficient use of the back during daily activities, self-management, self-efficacy and pain neurophysiology. Classes will run for a 12-week period. Participants will be encouraged to attend the exercise facility at least 3 times a week. An activity monitor will be provided to all participants. We will use group classes to facilitate the development of social support.
15941740|NCT03328689|Other|Control group standard care|"Participants from the control group will receive usual care which will often include recommendation to keep activity, home exercise programs and advice to engage in physical activity.
~Participants in the control group will also receive and activity monitor for collection of physical activity data. This activity monitor may also be used for positive feedback and activity reinforcement"
15941741|NCT03328676|Drug|Cannabis|Patients will receive study medication as drops applied under the tongue 3 times a day - morning, noon and evening, at a minimum of 4hr apart between administrations.
15941742|NCT03328676|Drug|Placebo oil|Patients will receive study medication as drops applied under the tongue 3 times a day - morning, noon and evening, at a minimum of 4hr apart between administrations.
15941743|NCT03328663|Other|CARE|Promote effective coping and reduce caregiving burden.
15941744|NCT03328663|Other|Standard Transplant Care|Standard cared administered by the hospital.
15941745|NCT03328637|Behavioral|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) consisting of weekly 12 sessions will focus on moderated and controlled use of smartphone instead of abstinence model.
15941746|NCT03328624|Device|Deep Vein Thrombosis (DVT) Cuff|Recovery Force's DVT II Cuff
15941747|NCT03328611|Device|Hip and Knee Joint Replacement|Hip and Knee Joint Replacement
15941748|NCT03328598|Behavioral|Positive psychology therapy group|This program is developed from a foreign group program based on positive psychology. The positive psychology therapy lasts 8 weeks, and has a group intervention in each week. The themes of each week are start-up, time gift, positive mind, three good things, a thankful heart, life train, active service, end-up.
15941749|NCT03328598|Behavioral|Resilience promotion therapy group|The other one is developed from research team's previous research results. The resilience promotion therapy lasts 8 weeks, and also has a group intervention in each week. The themes of each week are start-up, mutual help, trust in yourself, thanksgiving feedback, care for yourself, emotional management, end-up.
15941750|NCT03328598|Other|Controlled routine activity|Conventional community activities is viewed as an active comparator for controlled group.
15941751|NCT03328585|Behavioral|CBT-I in person|6 weeks of CBT-I in person, one 1-hour long session per week
15941752|NCT03328585|Behavioral|CBT-I via Telemedicine|6 weeks of CBT-I via telemedicine, one 1-hour long session per week
15941753|NCT03328585|Other|No intervention|Patients in this arm will receive no intervention but will receive CBT-I treatment after conclusion of the study
15941754|NCT03328572|Other|E-max Endocrown|Endocrown preparation
15941755|NCT03328572|Other|Cerasmart Endocrown|Endocrown preparation
15941756|NCT03328559|Diagnostic Test|ISET® - Isolation by Size of Tumor cells|early stage bronchial cancer patient will have a blood collection
15941757|NCT03328559|Diagnostic Test|ISET® - Isolation by Size of Tumor cells|advanced stage bronchial cancer patient will have a blood collection
15941758|NCT03328546|Other|Dietary intake|Dietary intake converted into dietary pattern scores.
15941759|NCT03328533|Drug|Phenylephrine|Phenylephrine variable infusion with a starting rate of 0.75 mcg/Kg/min.
15941760|NCT03328533|Drug|Norepinephrine|Norepinephrine bitartrate variable infusion with a starting rate of 0.1 mcg/Kg/min (equivalent to norepinephrine base of 0.05 mcg/Kg/min).
15941761|NCT03328533|Drug|Bupivacaine|Bupivacaine will be injected in the subarachnoid space with a dose of 10 mg.
15941762|NCT03328520|Behavioral|WILD 5 Wellness Intervention|"Behaviors in 6 areas of wellness: Sleep, Social Connectedness, Exercise, Nutrition, Mindfulness and HERO (Happiness, Enthusiasm, Resilience, Optimism)"
15941763|NCT03328507|Drug|BLI4900|BLI4900 Bowel Preparation
15941767|NCT03328481|Procedure|Loss-of-resistance Quadratus lumborum block|"ِA blunted 22-G, 11 mm, short-bevel facet needle will be introduced in the paravertebral line at the level of L3 or L4, in 30-45 degree to the skin directing it laterally. Once the skin barrier is breached, the needle will be withdrawn back so that the tip lies just under the skin. The needle will be advanced through the posterior thoracolumbar fascia and a first fast pop sensation will be felt when the needle pierced it. With further advancement of the needle, a second deep pop will be felt after it pierces the middle thoracolumbar fascia. At this point, the needle will be in the plane of the quadratus lumborum block type II. After careful aspiration, the 30 mLs of local anaesthetic will be injected. The needle will be visualized by the ultrasound by another physician to ensure safety."
15941768|NCT03328481|Procedure|Ultrasound-guided Quadratus lumborum block|A broadband (5-8 MHz) convex transducer will be placed transversely in the abdominal flank above the iliac crest to identify the external oblique, internal oblique, transversus abdominis muscles and aponeurosis. Then the external oblique muscle will be followed posteriorly until its posterior border is visualized (hook sign), and the posterior aspect of the Quadratus lumborum muscle is confirmed. A 22-G, 11-mm, short-bevel facet needle will be advanced under direct ultrasound visualization in-plane from anterolateral to postero-medial. Then the 30 ml of local anesthetic (bupivacaine 0.25 %) will be injected into the lumbar inter-facial triangle (LIFT) behind the quadratus lumborum muscle using hydro-dissection.
15941769|NCT03328481|Procedure|General anesthesia|Patients will receive 2 mg of midazolam and 8 mg of dexamethasone IV; then, they will be transferred to the operating room to receive a standard general anesthetic. Perioperative monitoring will include ECG, non-invasive arterial blood pressure, and pulse oximetry (SpO2) and end-tidal carbon dioxide. Anesthesia will be induced by propofol 1.5-2.5 mg/kg, atracurium 0.5 mg/kg, and fentanyl 2 mcg/kg to facilitate the insertion of an endotracheal tube. Anesthesia will be maintained by isoflurane 1-2% end-tidal concentration to maintain systolic arterial blood pressure and heart rate within + 20% of the baseline values. Ventilation will be adjusted to maintain normocapnia.
15941770|NCT03328468|Other|Breathing Exercise|Breathing exercise for stroke patients
15941771|NCT03328455|Behavioral|Active training|Perceptual training is task-related.
15941772|NCT03328455|Behavioral|Passive training|Training is not task-related.
15941773|NCT03328442|Procedure|VISTA Technique|VISTA with PRF membrane includes Treatment of recession class I and II using autologous PRF membrane
15941774|NCT03328442|Procedure|modified coronally advanced flap|modified coronally advanced flap with PRF membrane for Treatment of recession class I and II
15941775|NCT03328429|Other|Excision|Bartholin gland will be excised
15941776|NCT03328429|Other|Marsupialization|Bartholin gland will be marsupialised
15941777|NCT03328416|Device|Augmented Reality|The neurointerventional radiologist will have imaging information projected on a headset in addition to on the conventional monitors that hang from the procedure suite ceiling.
15941778|NCT03328403|Device|Aspiration First|Use aspiration system (mainly Penumbra) first, other devices would be used if the first device failed to open the occluded vessel satisfactorily, depending on clinical situation and the involved interventionists' preferences.
15941779|NCT03328403|Device|Stent retriever first|Use one of the stent retrievers (Trevo / Solitaire) first, other devices would be used if the first device failed to open the occluded vessel satisfactorily, depending on clinical situation and the involved interventionists' preferences.
15941780|NCT03328390|Other|Quadratus lumborum block|15 ml of 0.5% isobaric bupivacaine + 10 ml saline + 50 micro gram dexmedetomidine + epinephrine (1:100,000) for each side.
15941781|NCT03328390|Other|Transversus abdominis plane block|15 ml of 0.5% isobaric bupivacaine + 10 ml of saline + 50 micro gram dexmedetomidine + epinephrine (1:100,000) for each side.
15941782|NCT03328377|Diagnostic Test|Metagenomic analysis of gut microbiota|All patients have rectal swaps/fecal samples subjected to metagenomic analysis
15941783|NCT03328364|Drug|enzalutamide|oral
15941784|NCT03328364|Drug|docetaxel|intravenous infusion
15941785|NCT03328351|Other|manual therapy|"Manual therapy: One of the following techniques was used for the treatment group based on the patients' response (i.e centralization and reduction of symptoms).
~Cervical postero-anterior vertebral mobilization glides:
~a central posteranterior (PA) or unilateral PA oscillatory pressure of grade III on the patient's most symptomatic level for 2 minute and 3 sets .
~Cervical lateral vertebral glides :at grade III for 1 minute and 3 sets.
~Strengthening Exercises:
~for deep neck flexor muscles for 10 seconds and repeating it for 10 times."
15941786|NCT03328351|Other|Superficial soft tissue massage|"1. Superficial soft tissue massage: The researcher applied a superficial effleurage massage without moving the deeper tissue for 2 minutes for 3 sets
~Strengthening Exercises:
~for deep neck flexor muscles for 10 seconds and repeating it for 10 times"
15941787|NCT03328325|Biological|Influenza Virus Quadrivalent Inactivated Vaccine|A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 [H1N1] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) IVR-186, B/Maryland/15/2016 NYMC BX-69A, (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.
15941788|NCT03328325|Biological|Influenza Virus Quadrivalent Inactivated Vaccine|A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes and 2 influenza B subtypes: A/Singapore/GP1908/2015 (H1N1) IVR-180 (an A/Michigan/45/2015 [H1N1] pdm09-like virus), A/Singapore/INFIMH-16-0019/2016 (H3N2) NIB-104, B/Maryland/15/2016 NYMC BX-69A (a B/Colorado/06/2017-like virus), and B/Phuket/3073/2013.
15941789|NCT03328312|Drug|Sugammadex|Time period from administration of the reversal agent to recovery of TOFR >0.9
15941790|NCT03328312|Drug|neostigmine+atropine|Number and time of bradycardic episodes (HR<60 bpm) as well as that of tachycardic episodes (HR>100 bpm) before tracheal extubation
15941791|NCT03328312|Drug|neostigmine+atropine+sugammadex|4. Time of extubation
15941792|NCT03328299|Drug|Dexmedetomidine|20 ml of 0.5 % bupivacaine plus dexmedetomidine 1 μg•kg-1
15941793|NCT03328299|Drug|bupivacaine|20 ml of 0.5 % bupivacaine
15941794|NCT03328286|Behavioral|Weekly group meeting w/psychotherapist|Introduce a Psychotherapist in a work Integration program to further support Young adults in Job search and at the same time offering psychotherapeutic counselling. The participants will have a weekly meeting lasting 1.5 hour and additionally the can have 5 private counselling sessions with the psychotherapist if they wish
15941795|NCT03328273|Drug|Ceralasertib|An ATP competitive, orally bioavailable inhibitor of the Serine/Threonine protein kinase Ataxia Telangiectasia and Rad3 related (ATR).
15941796|NCT03328273|Drug|Acalabrutinib|An experimental anti-cancer drug and Bruton's tyrosine kinase (BTK) inhibitor.
15941797|NCT03328260|Device|HIFU|Transvaginal high intensity focused ultrasound to ablate uterine myoma
15941798|NCT03328247|Other|ASICA digital app|Participants in the intervention arm will be trained to use ASICA (in addition to completing routine follow-up) and participants within the control arm will continue to attend their usual structured melanoma follow-up only. The hypothesis is that the ASICA intervention will increase TSSE practice in those affected by melanoma without affecting psychological well-being and lead to earlier detection of recurrent and new primary melanoma.
15941799|NCT03328234|Radiation|SIB-IMRT|Patients receive radiotherapy once daily, 5 days a week for an average of 5.5 weeks. Radiotherapy is delivered to achieve a prophylactic dosage of 50.4Gy to PTV and 59.92Gy to PGTV in 28 fractions, respectively.
15941800|NCT03328234|Drug|Paclitaxel|45-50mg/m2, once a week, concurrent with radiotherapy for 5-6weeks
15941801|NCT03328234|Drug|Platinum-Based Drug|Nedaplatin or Lobaplatin or Cisplatin, 20-25mg/m2, once a week, concurrent with radiotherapy for 5-6weeks
15941802|NCT03328234|Drug|Paclitaxel|135-150mg/m2 on day1,every 3 weeks, 2 cycles, 1 month after completion of radiotherapy
15941803|NCT03328234|Drug|Platinum-Based Drug|Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin,50mg on day1 ),every 3 weeks, 2 cycles, 1 month after completion of radiotherapy
15941804|NCT03328234|Other|Involved Field Irradiation (IFI)|CTV was defined as GTV with a 3.0-5.0 cm craniocaudal margin and a 0.6-0.8 cm lateral margin and GTVnd with a 0.5-1.0 cm margin.
15941805|NCT03328208|Other|Comfort Talk® app|Test app
15941806|NCT03328208|Other|White Noise app|White Noise app built to mimic appearance of Comfort Talk® test app
15941807|NCT03328195|Device|Neuro RX Gamma synchronous|Twenty minute treatment, six days per week for 12 weeks
15941808|NCT03328195|Device|Sham|Twenty minutes, six days per week for 12 weeks with sham device
15941809|NCT03328195|Device|Neuro RX Gamma asynchronous|Twenty minutes, six days per week for 12 weeks with sham device
15941810|NCT03328182|Device|New oral endotracheal tube holder|The single arm study product is designed to hold a standard or subglottic ET tube.
15941811|NCT03328169|Behavioral|Mindfulness-Based Therapy|Participants are taught relaxation and mindfulness techniques to practice. They also learn about various alternative medicine modalities to which they can apply mindfulness with the target of reducing insomnia. The group meets weekly for 2 hours for a duration of 9 weeks.
15941812|NCT03328169|Behavioral|Cognitive Behavioral Therapy for Insomnia|A licensed psychologist is delivering Cognitive Behavioral Therapy for Insomnia to women for 90-120 minutes weekly for nine weeks. The Cognitive Behavioral Therapy for Insomnia protocol is well documented in published literature.
15941813|NCT03328143|Drug|Lavender (Lavandula angustifolia)|Lavender (Lavandula angustifolia) is an essential oil.
15941814|NCT03328130|Biological|AAV2/5-hPDE6B|Subretinal administration in one eye
15941815|NCT03328117|Drug|Imatinib|Over-encapsulated 100 mg imatinib mesilate tablets
15941816|NCT03328117|Drug|Placebo oral capsule|Matching placebo oral capsule
15941817|NCT03328104|Drug|Everolimus|Given once daily orally via mouth or NG tube beginning at Dose Level (DL) 1 (4 mg/m2/day). Depending on safety and tolerability, dose levels will be escalated to DL2 (5 mg/m2/day). There is also a dose level de-escalation to DL0 (3 mg/m2/day) if toxicity is noted at DL1. Begins at Day 1 through 28.
15941818|NCT03328104|Drug|Nelarabine|650 mg/m2 IV daily x Day 1-5
15941819|NCT03328104|Drug|Cyclophosphamide|440 mg/m2 IV x Day 1-5
15941820|NCT03328104|Drug|Etoposide|100 mg/m2 IV x Day 1-5
15941821|NCT03328091|Other|Traditional pre-test genetic counseling|Participant meets with a genetic counselor at the Center for Cancer Genetics and Prevention and traditional pre-test cancer genetic counseling is provided
15941822|NCT03328091|Other|Pre-test video education|The video is designed to mirror the educational components of a traditional genetic counseling visit
15941823|NCT03328078|Drug|CA-4948|CA-4948 (formulated for oral administration for QD or BID dosing)
15941824|NCT03328078|Drug|ibrutinib|560 mg QD of oral ibrutinib (or 420 mg QD for WM/LPL and CLL/SLL)
15941825|NCT03328065|Other|Interviews|Semi-directed interviews, recorded and transcribed for analysis
15941826|NCT03328065|Other|Questionnaires|economic and psycho-social questionnaires
15941827|NCT03328052|Device|MYnd Analytics PEER Online directed antidepressant therapy|"PEER Online is similar to a standard QEEG in that it uses QEEG output variables, but differs from a standard QEEG in that it references the QEEG to a normative and then symptomatic database. By comparing a given patient's QEEG to a database of QEEGs of subjects who have tried and responded to a specific medication, PEER Online can provide useful information regarding the response of neuro-physiologically similar patients to a wide number of medications. PEER Online may thus have the advantage of providing physicians with useful information as to medication outcomes before a medication regime is started. It has also been used to help select the medication that best matches the QEEG brainwave pattern, regardless of symptom clusters, currently used for diagnostic nomenclature. Patients will receive anti-depressant therapy guide by the results of the PEER Online algorithm."
15941828|NCT03328052|Other|Conventional antidepressant therapy|Anti-depressant therapy chosen based on physician best judgement.
15941829|NCT03328039|Device|Garmin wearable device|Physiological data capture only
15941830|NCT03328026|Biological|SV-BR-1-GM|SV-BR-1-GM inoculation intradermally in 4 sites on the upper back (x2) and thighs (x2).
15941831|NCT03328026|Biological|INCMGA00012|INCMGA00012 will be given 375 mg intravenously either ~2 or ~4 days after SV-BR-1-GM inoculation for up to 24 infusions. Cycles will be every 3 weeks.
15941832|NCT03328026|Drug|Low dose cyclophosphamide|Pretreatment with low dose cyclophosphamide 2-3 days prior to SV-BR-1-GM inoculation.
15941833|NCT03328026|Biological|Interferon Inoculation|Post-inoculation low dose Interferon-alpha-2b into the vaccination sites ~2 and ~4 days after SV-BR-1-GM inoculation.
15941834|NCT03328026|Drug|Epacadostat 600 mg BID|Epacadostat 600 mg twice daily given orally
15941835|NCT03328000|Radiation|CTU and MR urethrography|computed tomographic and Magnetic Resonance Urethrography.
15941859|NCT03327740|Drug|RAL or EGV based ARV regimens with ABC|RAL or EGV based regimens containing ABC
15941836|NCT03327987|Biological|standard of care influenza vaccine|The standard of care annual 2017-2018 influenza vaccine will be used for this study.
15941837|NCT03327974|Other|DEPASSE Apllication|"Application DEPASSE in depressed patients. This application was developed by the laboratory SERVIER, by a scientific committee of psychologists and psychiatrists: Pr. Courtet, Dr Rimlinger and Pr. Swendsen.
~Depasse is available for all on the App store and on Googleplay.
~This application has several interests:
~- The first is the daily monitoring of the symptoms allowing a regular evaluation throught smileys simulating a scale from 1 to 5. The 10 parameters evaluated are: mood, dark ideas, sleep, stress, concentration, social activities, energy, pleasure, motivation and libido.
~There is the possibility to generate a graph representing the evolution of these parameters.
~Tips adapted to the actual mood are provided related to the dysfunctional parameters."
15941838|NCT03327961|Device|scaffold|implantation of scaffold (eg Magmaris, Desolve, Others)
15941839|NCT03327948|Device|Axonics Sacral Neuromodulation System (SNM) System|Axonics Sacral Neuromodulation System (SNM) System
15941840|NCT03327935|Dietary Supplement|Nutrition|150 Faroese surgical patients randomized to one of the following three arms 1) oral nutritional supplements and advice, 2) oral nutritional supplements and training exercise and 3) Standard hospital procedure. Primary outcome is loss of lean body mass
15941841|NCT03327922|Device|Vicryl absorbable suture|Vicryl absorbable suture is a synthetic sterile surgical suture made up of a copolymer
15941842|NCT03327909|Behavioral|TAKE vs. HOLD|All participants will be told to take once daily antihypertensive medications at night. Timing of other antihypertensive medication administration will differ depending on whether the participant is randomized to the TAKE or HOLD arm.
15941843|NCT03327896|Other|Charlson score and Community Social Deprivation|This is an observational study of the association of clinical comorbidity and neighborhood social deprivation characteristics with healthcare performance assessment.
15941844|NCT03327857|Biological|Neihulizumab (AbGn-168H)|"Single dose phase: Patients will receive single dose of Neihulizumab at 3, 6, 9, or 12 mg/kg based on the escalation criteria.
~Multiple dose phase: Parients will receive the first dose of Neihulizumab at 6 mg/kg followed by weekly doses of 4 mg/kg Neihulizumab for 3 weeks (6-4-4-4 regimen)."
15941847|NCT03327831|Drug|Aminolevulinic Acid|Topical application followed by activation by ambient sunlight
15941848|NCT03327818|Procedure|hysterectomy|
15941849|NCT03327818|Procedure|uterine conservative study|
15941850|NCT03327805|Dietary Supplement|Choline|Participants will consume 1000 mg (2x500 mg) of choline bitartrate (over-the-counter supplement) for 14 consecutive days. At baseline, some participants will also be randomly assigned to consume 1000 mg of choline bitartrate the evening before the third testing session to study its acute effects.
15941851|NCT03327805|Dietary Supplement|Placebo|Participants will consume 1000 mg (2x500 mg) of placebo for 14 consecutive days. At baseline, some participants will also be randomly assigned to consume 1000 mg of placebo the evening before the third testing session to study its acute effects.
15941852|NCT03327792|Drug|Mavoglurant|200 mg Mavoglurant
15941853|NCT03327792|Drug|Placebo|Placebo
15941854|NCT03327766|Diagnostic Test|4-Measurment of serum 25(OH)D3 using Vidas by ELFA meathod.|A specialized test of the 25(OH)D serum level was conducted and the blood samples were collected in the months of November to April. The winter months were chosen intentionally in order to limit the impact of the sun light upon 25(OH)D serum level.The test VIDAS® 25 OH Vitamin D Total was used-enzyme immunoassay with highly fluorescent measurement ELFA. According to the reference values of this method the 25(OH)D < 20 ng/ml serum levels are considered as deficiency and the serum levels between 20 - 30ng/ml are defined as insufficiency. It's sufficient if the level of 25(OH)D is 30 to 100 ng/ml.
15941855|NCT03327753|Behavioral|Motor control exercises|The first stage of the treatment involves assessment of symptoms and implementation of a retraining program designed to improve activity of muscles assessed to have poor control and reducing activity of any muscle identified to be overactive. Participants are taught how to contract these muscles independently from the superficial trunk muscles and progress until the patient are able to maintain isolated contractions of the target muscles. During this stage exercises for breathing control, posture of spine and lower limb and movement are performed. The second stage of the treatment involved the progression of the exercises towards more functional activities. Throughout this process the recruitment of the trunk muscles, posture, movement pattern and breathing are assessed and corrected.
15941856|NCT03327753|Behavioral|Graded activity|The program is based on activities that each patient identify as problematic and that they cannot perform or have difficulty performing because of their back pain. The activities in the program are progressed in a time-contingent manner from the baseline assessed ability to a target goal set jointly by patient and therapist. Patients receive daily quotas and are instructed to only perform the agreed amount, even when they feel they are capable of doing more. Cognitive-behavioural principles are used to help patients overcome the natural anxiety associated with pain and activities. Physiotherapists use positive reinforcement, explain pain mechanisms and addressed negative behaviours and pain-related anxiety. A plan for managing relapses is developed between therapists and patients.
15941860|NCT03327740|Drug|RAL or EGV based regimens without ABC|RAL or EGV based ARV regimens that do not contain ABC
15941861|NCT03327740|Drug|Any other DTG based ARV regimen as monotherapy|Any other DTG based ARV regimens including DTG as monotherapy or two-drug regimens.
15941862|NCT03327727|Drug|Investigational Agent: VL-2397|VL-2397
15941863|NCT03327727|Drug|Standard treatment: Voriconazole, Isavuconazole, or Liposomal amphotericin B|Voriconazole, Isavuconazole, or Liposomal amphotericin B
15941864|NCT03327714|Behavioral|Mindfulness and compassion|
15941865|NCT03327701|Drug|Benralizumab|Subjects will receive benralizumab 30 mg (subcutaneous) every 4 weeks for three doses followed by a fourth dose 8 weeks later.
15941866|NCT03327688|Diagnostic Test|Point-of-care ultrasound|Point-of-care ultrasound performed by an emergency physician
15941867|NCT03327675|Other|68Ga-PSMA (HBED-CC) PET|68Ga-PSMA PET/MR
15941868|NCT03327662|Other|Active CTC Assessment|CTC Counts used to guide treatment switch
15941869|NCT03327649|Device|low level transcutaneous vagus nerve stimulation|Stimulation of the auricular branch of the vagus nerve
15941870|NCT03327636|Device|Echopulse|This is a machine to apply high intensity focused ultrasound to ablation the target zone. In this study, we would apply it to the papillary thyroid microcarcinoma.
15941871|NCT03327610|Other|VC-CMV20|Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV). The inspiratory flow was set at 20Lpm and the tidal volume was increased in steps of 200mL until the peak airway pressure of 40cmH2O was achieved. After achieving the target pressure, this ventilatory regimen lasted 15 minutes. Positive end expiratory pressure and the inspired oxygen fraction were not modified.
15941872|NCT03327610|Other|VC-CMV50|Application of a ventilator hyperinflation intervention with Volume Control Continuous Mandatory Ventilation (VC-CMV). The inspiratory flow was set at 50Lpm and the tidal volume was increased in steps of 200mL until the peak airway pressure of 40cmH2O was achieved. After achieving the target pressure, this ventilatory regimen lasted 15 minutes. Positive end expiratory pressure and the inspired oxygen fraction were not modified.
15941873|NCT03327610|Other|PC-CMV1|Application of a ventilator hyperinflation intervention with Pressure Control Continuous Mandatory Ventilation (PC-CMV1). The inspiratory time was set at 1 second and the pressure control was increased until a peak pressure of 40cmH2O was achieved. After achieving the target pressure, this ventilatory regimen lasted 15 minutes. Positive end expiratory pressure and the inspired oxygen fraction were not modified.
15941874|NCT03327610|Other|PC-CMV3|Application of a ventilator hyperinflation intervention with Pressure Control Continuous Mandatory Ventilation (PC-CMV1). The inspiratory time was set at 3 seconds and the pressure control was increased until a peak pressure of 40cmH2O was achieved. After achieving the target pressure, this ventilatory regimen lasted 15 minutes. Positive end expiratory pressure and the inspired oxygen fraction were not modified.
15941875|NCT03327610|Other|PSV10|Application of a ventilator hyperinflation intervention with Pressure Support Ventilation (PSV). The cycling off was set at 10% of peak inspiratory flow and the pressure support was increased until a peak pressure of 40cmH2O was achieved. After achieving the target pressure, this ventilatory regimen lasted 15 minutes. Positive end expiratory pressure and the inspired oxygen fraction were not modified.
15941876|NCT03327610|Other|PSV25|Application of a ventilator hyperinflation intervention with Pressure Support Ventilation (PSV). The cycling off was set at 25% of peak inspiratory flow and the pressure support was increased until a peak pressure of 40cmH2O was achieved. After achieving the target pressure, this ventilatory regimen lasted 15 minutes. Positive end expiratory pressure and the inspired oxygen fraction were not modified.
15941877|NCT03327597|Other|Clinical follow-up 1|Participants receive routine care outside the bounds of the trial. No further work-up.
15941878|NCT03327597|Other|Mental Health and Quality of Life questionnaire|Participants receive a Mental Health and Quality of Life questionnaire that will be answered electronically on the study website (www.blodskimun.is)
15941879|NCT03327597|Other|Standard follow-up or treatment.|Participants previously diagnosed as having MGUS or participants that have multiple myeloma or other lymphoproliferative diseases will receive standard clinical follow-up and treatment.
15941880|NCT03327597|Other|Clinical follow-up 2|Standard clinical follow-up according to International Myeloma Working Group (IMWG) guidelines.
15941881|NCT03327597|Other|Clinical follow-up 3|Intensive clinical follow-up with regular clinical assessment, laboratory testing and radiology imaging.
15941882|NCT03327597|Other|Clinical follow-up control|Control clinical visit
15941883|NCT03327584|Procedure|Arthrocentesis|Athrocentesis
15941884|NCT03327558|Drug|Apriso 0.375G ER CAP|ER capsule
15941885|NCT03327558|Drug|APRISO 375 mg extended-release capsules|375 mg extended-release capsules
15941886|NCT03327545|Device|Neural mobilization|Neural mobilization on the right side of the craniocervical region for a total of 12 minutes.
15941887|NCT03327545|Device|Soft tissue techniques and Stretching|Soft tissue techniques and Stretching on the right side of the craniocervical region for a total of 12 minutes
15941888|NCT03327545|Device|Control group|Did not receive any treatment.
15941889|NCT03327532|Procedure|Clinical examination centered on congestion|Clinical examination centered on congestion will be performed within 72 hours of admission and before discharge from hospital
15941890|NCT03327532|Procedure|Cardio-pulmonary and peritoneal ultrasound|Cardio-pulmonary and peritoneal ultrasound will be performed within 72 hours of admission and before discharge from hospital
15941891|NCT03327532|Biological|Blood sample retrieved for biological assessment and biobanking|Blood sample collection will be performed within 72 hours of admission and before discharge from hospital
15941892|NCT03327532|Other|Telephone interview|Telephone interview will be performed 3 months after discharge from hospital
15941893|NCT03327532|Biological|Urinary sample retrieved for biological assessment and biobanking|Urinary sample collection will be performed within 72 hours of admission and before discharge from hospital
15941894|NCT03327519|Behavioral|SHUTi|Sleep Healthy Using the Internet (SHUTi) is a self-guided, automated, interactive, and tailored web-based program modeled on the primary tenets of CBT-I: sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention.
15941921|NCT03327220|Device|iovera°|The iovera° device applies cold to a target nerve to cause a temporary peripheral nerve block based on a process called Wallerian degeneration (2nd degree axonotmesis) without disrupting connective nerve tissue.
15941895|NCT03327519|Behavioral|Emmi|The Emmi® program for insomnia contains educational information on physiological controls of sleep, sleep hygiene practices, healthy sleep behaviors (e.g., reduce time in bed, get up at the same time every day, go to bed only if sleepy, and do not stay in bed unless asleep), and sleep medications; assesses self-efficacy, and; allows patients to set individual goals.
15941896|NCT03327506|Drug|Alprazolam 0.5 mg|alprazolam 0,5 mg the eve and the morning of the surgery versus a preoperative hypnosis session
15941897|NCT03327493|Diagnostic Test|Biological|"We will assess in all patients under ECLS for the treatment of a cardiogenic shock at day 0 (ECLS initiation) day 3 and day ECLS weaning :
~Biological assessment:
~Adrenoreceptors α1, α2, β1, β2, β3 on monocytes and lymphocytes T helper by flow cytometry
~Lymphocytes Th1/Th2 pattern by flow cytometry
~Cytokines on plasma : Interleukin (IL) 4, IL 12, TNF α, INF γ , IL1, IL6, IL10
~Clinical assessment:
~Hemodynamic parameters
~Cumulated doses of catecholamines
~Cardiac output variation measured by echocardiography during a standardized weaning procedure of ECLS at a constant mean arterial pressure (only on day 3 and Day ECLS weaning)"
15941898|NCT03327480|Other|orthosis|Group 1: neoprebe CMC orthosis Group2: thermoplastic CMC orthosis
15941899|NCT03327467|Biological|Cord Blood Infusion|IV infusion of umbilical cord infusion (sibling or autologous)
15941900|NCT03327454|Biological|Benepali|Administered as specified in the treatment arm.
15941901|NCT03327441|Other|Almonds|Almonds will be provided as 15% energy
15941902|NCT03327441|Other|Omelette|Omelettes will be provided as 15% energy
15941903|NCT03327402|Drug|SHP465|SHP465 capsule will be administered at a dose of 6.25 mg, orally once daily for 4 weeks. SHP465 is comprised of sulfate salts of dextroamphetamine and amphetamine, with dextroamphetamine saccharate and amphetamine aspartate monohydrate, which provide a composite enantiomer ratio of 3:1 d-amphetamine to l-amphetamine.
15941904|NCT03327389|Drug|Dexmedetomidine|dexmedetomidine was infused at a rate of 0.4 μg/kg/h starting immediately after anesthetic induction and continued until skin closure.
15941905|NCT03327389|Drug|placebo|0.9% NaCl was infused at a rate of 0.4 μg/kg/h starting immediately after anesthetic induction and continued until skin closure
15941906|NCT03327376|Device|ultrasound-screening|Daily ultrasound-screening for CVC-related thrombosis (DUCT) by compression ultrasound and color doppler ultrasound.
15941907|NCT03327363|Device|Feedback using ICT based monitoring system|In experimental group, the subjects the check their lung function using self FEV1 monitoring device (microlife PF-200). They send the information to central monitoring system(EDC systems). In case of decreased FEV1 compared with own average FEV1, the ICT based monitoring system send the feedback message to the subject and medical staffs.
15941908|NCT03327350|Device|WATCHMAN transplantation|WATCHMAN Left Atrial Appendage System is a novel device designed to prevent the embolization of thrombi that may form in the LAA. It is hypothesized that it may prevent ischemic stroke and systemic
15941909|NCT03327350|Drug|Oral anticoagulant drugs|This group will take oral anticoagulant drugs(warfarin or the new oral anticoagulant drugs like Dabigatran ).For patients taking warfarin,international normalizedratio (INR) monitoring wil be performed at least every 2 weeks for 6 months and at least monthly thereafter, targeting an INR between 2 and 3. Followup visits occurred twice annually after the first year,with neurological assessments at 12 months and yearly thereafter or whenever a neurological event is suspected.
15941910|NCT03327337|Procedure|Arthroscopic Assisted Balloon Tibioplasty|Under arthroscopy, the balloon supports the articular surface, with additional bone graft and necessary internal fixation
15941911|NCT03327324|Diagnostic Test|Sleep Using Mentored Behavioral and Environmental Restructuring|SLUMBER is a non-pharmacological intervention program, delivered by providing mentoring to facility staff who work directly with residents. SLUMBER focuses on detecting sleep-disruptive factors including: nighttime noise and patient behaviors associated with poor sleep quality; disruptions caused by nighttime caregiving; daytime inactivity; and limited light exposure. In this model, staff-delivered interventions to improve these factors improve sleep quality thereby creating opportunities to test the impact of improving sleep quality (measured by actigraphy) on mood (depression and anxiety), pain, cognitive function, functional ability, and observed activity levels.
15941912|NCT03327311|Device|Bellafill|Bellafill injected into site of pre-planned surgery (i.e., mini-abdominoplasty or redundant abdominal tissue removal) at two depths (dermis & deep dermis).
15941913|NCT03327298|Procedure|pedicle screw fixation|One hundred forty four screws were placed in the lumbosacral pedicles of 32 patients using free hand technique depending on direct visualization of the pedicles, roots, and intervertebral disc ( IVD) after doing full laminectomy, then postoperative CT was done for evaluation of pedicle violation.
15941914|NCT03327285|Biological|C-CAR011|CBM.CD19-targeted chimeric antigen receptor T cells(C-CAR011)
15941915|NCT03327272|Drug|Methylprednisolone|Injection of 80mg Depomedrol injectable suspension at surgical site prior to incision closure
15941916|NCT03327272|Drug|Saline|Administration of saline at surgical site prior to incision closure
15941917|NCT03327259|Behavioral|Activity Planning|The therapist will work with the participant to select a challenging, yet rewarding or value-driven activity that he/she can engage in 5x and monitor daily over the upcoming week.
15941918|NCT03327259|Behavioral|Therapist Guided Activity Practice|The therapist will work with the participant to plan and carry out a brief in-vivo version of their goal/target activity. The therapist will guide the participant through the activity for approximately 15 minutes.
15941919|NCT03327246|Device|Connecare self managment system|The CONNECARE SMS will rely on a hybrid solution that, besides being autonomous (the patient may use the SMS to monitor and access to her/his data and information), has also a collaborative component (through the interaction with the SACM) to allow participation by clinicians and to provide feedback to them. In so doing, the patient may control her/his activity, receiving recommendations to improve the treatment and to be encouraged in following it.
15941920|NCT03327233|Device|Connecare self managment system|The CONNECARE SMS will rely on a hybrid solution that, besides being autonomous (the patient may use the SMS to monitor and access to her/his data and information), has also a collaborative component (through the interaction with the SACM) to allow participation by clinicians and to provide feedback to them. In so doing, the patient may control her/his activity, receiving recommendations to improve the treatment and to be encouraged in following it.
15941922|NCT03327207|Other|Non Interventional|Non Interventional
15942685|NCT03321227|Other|Yogurt|A serving of full fat yogurt that is isocaloric to the 2 whole eggs
15941923|NCT03327194|Device|ADHEAR Audio Processor|"ADHEAR Audio Processoris a non-invasive bone conduction hearing device which is retained on the patient's head with an adhesive adapter that is placed behind the auricle.
~The ADHEAR Audio Processor transmits sounds to the mastoid by vibrating on the skull and stimulates the inner ear without any previous surgery.
~ADHEAR Audio Processor is classified as a Class lla medical device and ADHEAR Adhesive Adapter is classified as a Class I medical device.
~The ADHEAR Audio Processor has the CE mark."
15941924|NCT03327181|Dietary Supplement|short chain fatty acid tracers|stable tracer infusion of acetate, propionate, and butyrate
15941925|NCT03327168|Drug|Adenosine|Intravenous infusion of adenosine (0.14 mg/kg) is administered for 5 minutes during PET/CT scan.
15941926|NCT03327168|Other|Cold exposure|Controlled cold exposure is performed before and during PET/CT scan.
15941927|NCT03327155|Drug|Tenofovir disoproxil fumarate (TDF)/emtricitabine (FTC)|One tablet, containing 300mg of TDF and 200mg of FTC once daily with food.
15941928|NCT03327142|Diagnostic Test|Endoscopic Ultrasound-Guided FNA|Endoscopic Ultrasound Guided Fine Needle Aspiration of Puncture of Adrenal Glands
15941929|NCT03327129|Procedure|fMRI|An fMRI scan will be conducted to collect neuroimaging data. The scanning session will consist of a structural MRI, followed by resting state and task-based functional MRI protocol.
15941930|NCT03327116|Drug|Methotrexate|oral, 15 mg per week, 24 weeks
15941931|NCT03327103|Behavioral|CHAMPION|An interactive mHealth decision aid that includes immediate and over time quality of life (QL) graphical summaries for advanced prostate cancer patients to enhance informed, shared decision making and will also be used to assess the CPNs' role in the decision-making process.
15941932|NCT03327090|Other|Kinesio Tape original brand (Kinesio® Tex GoldTM finger print, black, Georgia, Albuquerque).|Kinesio Tape: An elastic therapeutic tape, which mimics the skin's thickness. It is a cotton, porous fabric and acrylic adhesive, which is non-medicated and free of latex. The Kinesio Tape is applied in a specific manner to enhance muscle function, increase circulation, decrease pain and improve proprioception.
15941933|NCT03327077|Other|Live Preferential Music|Trained musicians will play live preferential music to ED patients who consent to participate.
15941934|NCT03327064|Drug|UAB30|9cUAB30 promotes homodimer and heterodimer formation with retinoic acid receptors (RARs), and was shown to inhibit breast tumor development in the N-methyl-N-nitrosourea (MNU)-induced rat mammary gland carcinoma model. The compound has also shown efficacy in rodent models of skin cancer. Dose administration will be 160mg daily for 28 days.
15941935|NCT03327064|Drug|Placebo|This matches the UAB30 in appearance. Frequency of dosing will be daily for 28 days.
15941936|NCT03327051|Drug|Omeprazole|Proton pump inhibitor (PPI) that suppresses gastric acid secretion
15941937|NCT03327051|Dietary Supplement|VSL #3|Probiotics
15941938|NCT03327051|Drug|Placebo|Placebo to match omeprazole
15941939|NCT03327038|Behavioral|Web-Based Cognitive Behavioral Therapy|Patients will receive access to a 5-week web-based CBT program entitled 'Mood Gym'. The program is derived from traditional, therapist-directed cognitive behavioral therapy. The program consists of 5 modules, and patients will asked to complete 1 module per week over, during weeks 2-6 over their intervention period.
15941940|NCT03327038|Other|Short Questionnaires|Patients will receive emails to complete bi-weekly, web-based questionnaires at weeks 2, 4, and 6 of their intervention period. The short questionnaires will ask to patients to self-report their Depression (PHQ-9) and Anxiety (GAD-7) symptoms; along with their Crohn's Disease activity (PRO-2) or Ulcerative Colitis Disease Activity (MAYO-6).
15941941|NCT03327038|Behavioral|Nurse Monitoring|Patient responses to the short questionnaires will be monitored by an IBD advanced practice nurse. The IBD nurse will determine if there are elevations in anxiety, depression, and disease activity over the intervention period. Based on patient responses to the short questionnaires, the nurse will follow-up with patients via email or telephone to address patient symptoms. If there are clinically important changes in the patients' disease activity the nurse may also arrange for the patients to receive expedited outpatient follow-up with their gastroenterologist.
15941942|NCT03327038|Other|Detailed Questionnaires|Patients will complete a detailed questionnaires at enrollment (i.e. week 1 of enrollment) and also at post-intervention (i.e. week 8 of enrollment). The enrollment questionnaire will query the patients Ulcerative Colitis Disease Activity (MAYO-6) or Crohn's Disease Activity (PRO-2); Quality of Life (SIBDQ); and Patient Satisfaction with Health Care in IBD (CACHE). The post-intervention questionnaire will query the same information as the enrollment questionnaire but will also ask patients to self-report their depression (PHQ-9) and anxiety (GAD-7) symptoms.Quality of Life will be measured using the 10 item Short Inflammatory Bowel Disease Questionnaire (SIBDQ), which has a total score range of 10 to 70, with higher scores indicating better quality of life. Patient Satisfaction with Health Care in IBD will be measured using the 32 item CACHE Questionnaire, which scores from 0 -least satisfaction to 100-highest satisfaction.
15941943|NCT03327038|Other|Screening Form|Patients will complete a screening form at routine IBD outpatient visits to Mount Sinai Hospital to self-report their depression and generalized anxiety symptoms. Their depression symptoms will be reported on the 9-item Patient Health Questionnaire (PHQ-9), which has a total score ranging from 0 to 27, with scores of 5, 10, 15 and 20 representing cut points for mild, moderate, moderately severe, and severe depression. Their generalized anxiety symptoms will be reported on the 7-item Generalized Anxiety Disorder Questionnaire (GAD-7), which has a total score ranging from 0 to 21, with scores of 5, 10, and 15 representing cut points for mild, moderate, and severe anxiety. Patients who self-report scores of moderate depression AND/OR moderate anxiety will be eligible to participate in this study.
15941944|NCT03327025|Behavioral|Health education counseling|Health education counseling
15941945|NCT03327012|Drug|Treatment of Panlongqi Tablet|Panlongqi Tablet:1.2g,3times a day, oral, for 4 weeks.
15941946|NCT03327012|Drug|Treatment of Panlongqi placebo|Panlongqi placebo:1.2g,3times a day, oral, for 4 weeks.
15941947|NCT03326999|Drug|Obturator nerve regional block|Obturator nerve regional block involves the injection of a local anesthetic called bupivacaine into the upper thigh.
15941948|NCT03326999|Drug|Adductor canal regional block|Adductor canal regional block, which involves injecting numbing medication in the thigh region for pain control.
15941949|NCT03326999|Drug|Saline|Saline as placebo comparator
15941950|NCT03326986|Drug|MK-7252|1 mg/mL or 20 mg/mL of powder for oral suspension administered with a water volume that brings the total ingested volume to approximately 240 mL
15942806|NCT03320330|Other|Pharmacological Study|Correlative studies
15941951|NCT03326986|Drug|Placebo|Placebo powder for oral suspension administered with a water volume that brings the total ingested volume to approximately 240 mL
15941952|NCT03326973|Behavioral|EuroQoL EQ-5D-3L|Overall QOL
15941953|NCT03326973|Behavioral|EORTC QLQ-C30|General symptoms; physical, role, emotional, cognitive, and social functioning scales; fatigue, nausea/vomiting , and pain scales
15941954|NCT03326973|Other|PRO-CTCAE|Additional potential immune-specific symptoms
15941955|NCT03326973|Behavioral|Fatigue severity score questionnaire|Fatigue severity
15941956|NCT03326973|Behavioral|The COST|Financial toxicity; satisfaction with ability to work
15941957|NCT03326973|Behavioral|Physician information|Details on outside health providers
15941958|NCT03326960|Drug|Sevoflurane|Anesthesia maintenance with sevoflurane guided by Narcrotrend index monitoring.
15941959|NCT03326960|Drug|Propofol|Anesthesia maintenance with propofol guided by Narcrotrend index monitoring.
15941960|NCT03326960|Drug|Desflurane|Anesthesia maintenance with desflurane guided by Narcrotrend index monitoring.
15941961|NCT03326947|Drug|docetaxel, cisplatin and 5-fluorouracil|"Drug: TPF induction chemotherapy TPF induction chemotherapy: 2 cycles; docetaxel(75mg/m^2), cisplatin(75 mg/m^2), 5-Fu(750 mg/m^2/day) for 5 days; 16 days later, the 2nd cycle. 2 weeks later, surgery.
~Surgery: radical resection and full neck dissection with reconstruction. Radiotherapy: 4-6 weeks after surgery, 1.8-2Gy/day, 5 days/week for 6 weeks, and totally 54-60Gy, for high risk factors, concurrent chemotherapy with cisplatin of 80mg/m2.
~Other Names:
~TPF protocol group Procedure/Surgery: surgery In the TPF group,surgery was performed at least 2 weeks after completion of induction chemotherapy.Surgery group includes radical resection of the primary lesion and full neck dissection(functional or radical) with proper reconstruction(pedicle or free flap) were performed.
~Radiation: radiotherapy"
15941962|NCT03326934|Dietary Supplement|Dark chocolate|Trader Joe's 72% Cacao Dark Chocolate bar, 47g, 34g cacao, total flavanols: 316.3 mg.
15941963|NCT03326934|Dietary Supplement|Milk Chocolate|Trader Joe's Crispy Rice Milk Chocolate bar: 40g, 12.4g milk chocolate cocoa; total flavanols: 40 mg.
15941964|NCT03326921|Biological|CD8+ and CD4+ Donor Memory T-cells-expressing HA1-Specific TCR|Given IV
15941965|NCT03326921|Drug|Fludarabine|Given IV
15941966|NCT03326921|Other|Laboratory Biomarker Analysis|Correlative studies
15941967|NCT03326908|Device|Spectral Domain Optical Coherence Tomography|Five SD-OCTs will be performed with various conditions of enlightenment.
15941968|NCT03326895|Device|Left-sided colon resection|Left-sided colon resection with powered stapler
15941969|NCT03326882|Device|Endotracheal intubation|
15941970|NCT03326869|Device|Raindrop Near Vision Inlay|The Raindrop Near Vision Inlay was approved by the US FDA in June of 2016 for the improvement of near vision in presbyopic emmetropes. Raindrop is a clear device made of a hydrogel material and resembles a microscopic contact lens; it is the first implantable device that changes the shape of the cornea to correct the refractive errors that cause near vision problems.
15941971|NCT03326856|Biological|botulinum toxin, Type A|topical liniment
15941972|NCT03326856|Biological|Vehicle|Vehicle Formulation
15941973|NCT03326843|Drug|Avatrombopag 60 mg|Oral avatrombopag administered once daily for 5 days prior to procedure.
15941974|NCT03326830|Device|High-flow nasal oxygen|oxygen therapy will be delivered through a dedicated system, the Airvo2™ (Fisher&Paykel, New-Zealand).
15941975|NCT03326830|Device|Standard oxygen therapy|Oxygen therapy will be delivered using standard devices such as nasal canula or face mask with or without rebreathing bag
15941976|NCT03326817|Other|Control Group|Patients receive standard care
15941977|NCT03326817|Device|Soft Robotic Glove Group|This group will receive standard care and soft robotic therapy (continuous passive motion device developed by National University of Singapore).
15941979|NCT03326791|Drug|Acetylsalicylic acid|Trombyl 160 mg once daily
15941980|NCT03326791|Drug|Placebo Oral Tablet|Placebo one tablet daily
15941981|NCT03326778|Procedure|AVR and CABG|Combined AVR with CABG
15941982|NCT03326765|Other|Questionnaires|"Epworth sleepiness scale
~Pittsburgh sleep quality Index (PSQI)
~EQ-5D Adults
~Pediatric Daytime Sleepiness scale (PDSS)
~Sleep disturbance Scale for Children (SDSC
~EQ-5D Children
~Sleaping diary"
15941983|NCT03326765|Procedure|electroencephalogram (EEG)|is an electrophysiological monitoring method to record electrical activity of the brain
15941984|NCT03326765|Procedure|polysomnography|type of sleep study, is a multi-parametric test used in the study of sleep and as a diagnostic tool in sleep medicine
15941985|NCT03326765|Procedure|Actigraphy|type of sleep study based on bracelet around the wrist
15941986|NCT03326752|Drug|DV281|- Dose Escalation will be the preliminary dose finding phase of the study. Subjects will be enrolled to available Dosing Cohorts.
15941987|NCT03326752|Device|Breath Actuated Nebulizer|Breath-actuated, electronic system designed to aerosolize liquid medication.
15941988|NCT03326752|Drug|DV281 (RP2D)|- Dose Expansion will be enrolled into 4 groups based on NSCLC characteristics.
15941989|NCT03326752|Drug|Approved Anti-PD-1 Inhibitor|FDA approved Anti-PD-1 Inhibitor
15941990|NCT03326739|Procedure|Arterial Line Placement|arterial line placement
15941991|NCT03326726|Drug|2% CHG|Chlorhexidine Gluconate
15941992|NCT03326713|Behavioral|Telephone Counseling & Navigation (TCN)|A health coach will conduct a 15-30 minute telephone counseling session with participants. Prior to the telephone session, participants will receive the same brochure that the TP arm receives. After the phone call, participants will receive a tailored follow-up letter which will include images tailored to the individual's age, self-identified ethnicity, and family composition.
15941993|NCT03326713|Behavioral|Mailed Targeted Print (TP)|Participants will be mailed an educational brochure within two weeks of completing the baseline survey that addresses important evidence-based theoretical targets: CGRA guideline (knowledge), threat appraisal (to validate or raise risk perceptions, HBOC seriousness), response efficacy (benefits and expectations about CGRA), self-efficacy messages (CGRA resources, insurance reimbursement, and assistance for those with financial challenges) and possible actions to take (make an appointment and discuss with provider). Both the targeted print and tailored intervention materials were developed using formative community engaged research methods.
15976793|NCT03061058|Drug|Pemetrexed|intraperitoneal and/or intravenous
15941994|NCT03326713|Other|Usual Care (UC)|A usual care arm is included to assess CGRA uptake in the absence of intervention as well as priming from the surveys for the primary outcome analysis.
15941995|NCT03326700|Procedure|Inguinal Hernia Repair|Inguinal hernia repair is surgery to repair a hernia in the groin. A hernia is tissue that bulges out of a weak spot in the abdominal wall. The intestine may bulge out through this weakened area. During surgery to repair the hernia, the bulging tissue is pushed back in. The abdominal wall is strengthened and supported with sutures (stitches), and sometimes mesh. This repair can be done with open or laparoscopic surgery.
15941996|NCT03326687|Behavioral|Treatment ABAB|Participants will perform the phases in the ABAB order.
15941997|NCT03326687|Behavioral|Treatment BABA|Participants will perform the phases in the BABA order.
15941998|NCT03326674|Drug|Tesetaxel and Capecitabine|Tesetaxel plus reduced dose of Capecitabine
15941999|NCT03326674|Drug|Capecitabine|Capecitabine alone at approved dose
15942000|NCT03326661|Procedure|Aspiration|Needle aspiration of pus from the peritonsilar abscess
15942001|NCT03326661|Procedure|Tonsillectomy a chaud|Removal of tonsil(s) due to peritonsillar abscess
15942002|NCT03326661|Drug|Penicillin V + metronidazol (Penicillin allergy: Clindamycin alone)|patients treated with aspiration will receive antibiotic treatment
15942003|NCT03326648|Other|Strength training|Heavy load strength training performed twice a week for 10 weeks.
15942004|NCT03326648|Dietary Supplement|Protein supplementation|Dietary protein supplement (protein-enriched milk with 0,2 % fat). 0,33 l each day for 10 weeks.
15942005|NCT03326635|Other|Frailty in elderly (≥70 y) patients in ICU|Determine the prevalence of frailty in elderly patients (≥ 70 year old) in a group of French ICUs. The frailty is measured by a score (Fried score) at the admission of the patient
15942006|NCT03326622|Other|standard care|A standard care program based on American Academy of Neurology guidelines (Range Of Motion (ROM) exercises, gait and balance training )at home or another rehabilitation units without intensity control.
15942007|NCT03326622|Other|moderate exercise|A moderate exercise protocol two times per week in a treadmill in the lower range of the training zone determined by Cardiopulmonary Exercise Testing, monitored by continuous pulse oximetry evaluation.
15942008|NCT03326609|Drug|Ropivacaine|Perineural injection using a peripheral nerve block catheter and a constant infusion rate (10mL/h)
15942009|NCT03326596|Drug|Tranexamic Acid 1000 mg/10ml normal saline infusion|Infusion of Tranexamic Acid (Cyklokapron) to all consented women with the delivery of the anterior shoulder of the infant
15942010|NCT03326583|Drug|Patiromer|Patiromer will be orally self-administered by participants.
15942011|NCT03326570|Behavioral|Medical Data Collection|Medical information collected after bronchoscopy for up to 2 years.
15942012|NCT03326557|Procedure|Membrane Sweeping versus Transcervical Foley Catheter for Induction of Labour in Women with Previous Caesarean Delivery|Subjects undergoing induction of labour (IOL) will be randomly assigned to two interventional arms (Group 1: membrane sweeping or Group 2: transcervical Foley catheter insertion). Before IOL, modified Bishop score will be assessed for cervical favourability. After 24 hours of IOL, improvement of modified Bishop score will be reassessed. If the cervix is favourable, amniotomy will be performed followed by augmentation with intravenous oxytocin. If the cervix is still unfavourable and amniotomy is impossible, membrane sweeping will be continued for one more day in Group 1 whereas conservative management will be undertaken for one day in Group 2. Suitability for amniotomy will be reassessed on the next day. After amniotomy, subsequent intrapartum management will be based on the hospital protocol. If amniotomy is still impossible after 2 days of IOL, the ward Obstetrician will discuss with women regarding option of Caesarean section.
15942013|NCT03326544|Other|Saphenous nerve block group|Patients will receive ultrasound-guided intervention treatment with a sub-sartorial approach for a saphenous nerve block with 8 mL of bupivacaine 0.5% plus dexamethasone 4 mg
15942014|NCT03326544|Other|Platelet rich plasma group|Patients will receive intra-articular ultrasound-guided injection of 5 mL of autologous Platelet rich plasma
15942015|NCT03326531|Other|Not applicable for this study|Not applicable for this study
15942016|NCT03326518|Diagnostic Test|Lumentin® 44|Contrast agent
15942017|NCT03326518|Diagnostic Test|Diluted Omnipaque®|Contrast agent
15942018|NCT03326518|Diagnostic Test|Movprep®|Contrast agent
15942019|NCT03326505|Biological|Umbilical cord derived Mesenchymal Stem Cells|Allogenic umbilical cord derived stem cells which are to be injected intrathecally as a treatment option for consenting MS patients
15942020|NCT03326505|Other|Supervised physical therapy|A combined physical therapy program of Balance, strengthening and endurance exercises
15942021|NCT03326492|Drug|Antivenom serum Inoserp Pan-Africa® injection|Participation to the study does not change usual follow-up of patients. All medical procedures will be performed and products will be used in a routine manner. Antivenom serum Inoserp Pan-Africa® injection will be decided according to the clinical evaluation of the patient.
15942022|NCT03326479|Diagnostic Test|Caris Molecular Intelligence Profile|A comprehensive biomarker testing
15942023|NCT03326453|Device|Mini dental implant|titanium mini dental implant which diameter less than 3 mm
15942024|NCT03326440|Other|VERT system|3D images of radiotherapy planning and administration using the VERT (Virtual Environment Radiotherapy) system is shown either prior to Radiotherapy (study arm) or post Radiotherapy (control arm)
15942025|NCT03326427|Behavioral|Skill Training Group of the Dialectical Behavior Therapy|A 12 session version of the Skill Training Group of the Dialectical Behavior Therapy, adapted for treatment of ADHD.
15942026|NCT03326427|Other|Treatment as Usual|Conventional protocol using only medication (including drug adherence).
15942027|NCT03326414|Procedure|Constant PEEP - low tidal volume|The respirator is set according to study protocol
15942028|NCT03326414|Procedure|Constant PEEP - high tidal volume|The respirator is set according to study protocol
15942029|NCT03326414|Procedure|constant tidal volume - low PEEP|The respirator is set according to study protocol
15942030|NCT03326414|Procedure|constant tidal volume - high PEEP|The respirator is set according to study protocol
15942031|NCT03326388|Drug|Selumetinib|Selumetinib Intermittent Dosing
15942032|NCT03326375|Radiation|SBRT|Maximum dose : 60Gray (Gy) Fraction : 2 to 5
15942033|NCT03326362|Other|Resistance training|Comparison between high and low intensities trainings described in arms
15976794|NCT03061058|Drug|S1|oral
15942034|NCT03326349|Other|Guttmann, NeuroPersonalTrainer|Guttmann NeuroPersonalTrainer (GNPT) is a telerehabilitation platform. GNPT consists of a set of computerized cognitive exercises covering different cognitive functions and subfunctions. Every task has been specifically based on cognitive paradigms to address specific cognitive subfunction. The rehabilitation process starts by assigning a patient to a therapist responsible for the treatment. The therapist has then to perform the initial neuropsychological assessment, consisting of a set of validated tests used to attention, memory and executive functions prior to the treatment. The results of these tests will be stored in GNPT system. Then, the cognitive profile is calculated using these results, and taking into account the patient's age and study level. Using this profile, the program assigns a set of computerized tasks to a certain day, configuring the input parameters of each task in order to personalize treatments.
15942035|NCT03326349|Other|Ictus.online|"An online domain which provides a daily session of one hour of duration. Each session consists of four ten-minute videos. After each video, the participant must complete a three-question quiz about the contents of the video (for example, What animal appears in in the video?). The difficulty level is minimal, and does not vary depending on the execution of the participant."
15942036|NCT03326336|Combination Product|Gene therapy: GS030-DP AND Medical device: GS030-MD|GS030-Drug Product (GS030-DP) - Recombinant adeno-associated viral vector, derived from serotype 2 (rAAV2.7m8), containing the optimized channelrhodopsin ChrimsonR-tdTomato gene under the control of the ubiquitous CAG promoter (rAAV2.7m8-CAG-ChrimsonR-tdTomato) GS030-Medical Device (GS030-MD) - Visual Interface Stimulating Glasses (that amplify the external visual stimulus to the optogenetically engineered retina)
15942037|NCT03326323|Procedure|Acute Normovolemic Hemodilution|Collection and reinfusion of a patients own blood during coronary artery bypass graft surgery.
15942038|NCT03326310|Drug|Azacitidine|"Patients will receive azacitidine 75 mg/m2 as a subcutaneous injection on days 1-7. The dose of azacitidine 75 mg/m2 will remain unchanged, unless a dose reduction is required based on toxicities (dose level -1 = selumetinib 50 mg PO twice daily and azacitidine 50 mg/m2).
~Subjects will continue on this schedule in cycles of 28 days duration in the absence of disease progression"
15942039|NCT03326310|Drug|Selumetinib|"Patients will receive selumetinib administered by mouth on days 8-21. The starting dose cohort (dose level 1) will receive selumetinib 50 mg PO twice daily on days 8-21. Subsequent planned doses include selumetinib 75 mg PO twice daily (dose level 2) and selumetinib 100 mg PO twice daily (dose level 3). Subsequent dose levels will only be given once the prior dose level has shown acceptable safety.
~Subjects will continue on this schedule in cycles of 28 days duration in the absence of disease progression."
15942040|NCT03326297|Other|Osteopathy manual therapy|Technique for the treatment of parasympathetic innervation, Techniques for the treatment of sympathetic innervation of the digestive system, Functional visceral techniques.
15942041|NCT03326297|Behavioral|Measures to support and education to the family|Pedagogical intervention in parents and health education
15942042|NCT03326284|Other|15 g protein hypocaloric|Following a 5 day hypocaloric diet one group of 10 women will ingest 15 g of protein
15942043|NCT03326284|Other|35 g protein hypocaloric|Following a 5 day hypocaloric diet one group of 10 women will ingest 35 g of protein
15942044|NCT03326284|Other|60 g protein hypocaloric|Following a 5 day hypocaloric diet one group of 10 women will ingest 60 g of protein
15942045|NCT03326284|Other|35 g protein energy balance|Following a 5 day energy balanced diet one group of 10 women will ingest 35 g of protein
15942046|NCT03326271|Procedure|Exeter stem|Patients treated with an total or hemiarthroplasty using a Exeter stem for a displaced femoral neck fracture
15942047|NCT03326271|Procedure|Lubinus SP2 stem|Patients treated with an total or hemiarthroplasty using a SP2stem for a displaced femoral neck fracture
15942048|NCT03326258|Drug|Glembatumumab Vedotin|Given IV
15942049|NCT03326258|Biological|Ipilimumab|Given IV
15942050|NCT03326258|Other|Laboratory Biomarker Analysis|Correlative studies
15942051|NCT03326258|Biological|Nivolumab|Given IV
15942052|NCT03326258|Other|Pharmacological Study|Correlative studies
15942053|NCT03326245|Drug|Oral Methylphenidate followed by IV placebo|Oral MP (60 mg) will be given 30 minutes prior to bolus [11C]raclopride injection followed by iv placebo (PL) given 30 minutes post bolus injection of [11C]raclopride.
15942054|NCT03326245|Drug|Oral placebo followed by IV Methylphenidate|Oral PL will be given 30 minutes prior to bolus [11C]raclopride injection followed by iv MP (0.25 mg/kg) given 30 minutes post bolus injection of [11C]raclopride.
15942055|NCT03326245|Drug|Oral Placebo followed by IV Placebo|Oral PL will be given 30 minutes prior to bolus [11C]raclopride injection followed by iv PL given 30 minutes post bolus injection of [11C]raclopride.
15942056|NCT03326232|Device|Continuous glucose monitoring|The blinded CGM group will be using the Medtronic iPro2 system (Enlite sensor + iPro2 transmitter). The real-time CGM group will be using the 530g system (inactivated 530g insulin pump (no insulin used, only used as display for CGM), Enlite sensor, MiniLink transmitter)
15942057|NCT03326219|Procedure|Clarivein|The Clarivein technique uses mechanical damage to the endothelium of the vein wall through a rotating tip of the catheter. At the same time a sclerosans is injected, causing occlusion of the vein. No heating is used in this technique .
15942058|NCT03326206|Other|COPE Program|The COPE Program is a programmatic model that is designed to support to providers, Community Health Representatives, and patients/family members. Patients are referred to the COPE Program under program auspices. COPE referral and participation is part of routine care at all service units in Navajo Area Indian Health Services, and enrollment is not influenced by study participation. Patients receive the same health care services in the same manner and intensity, whether or not they are not enrolled in this observational study.
15942059|NCT03326193|Drug|Niraparib|Niraparib will be administered orally once a day continuously throughout each 21 day cycle. The starting dose of niraparib will be based on the participant's Baseline actual body weight or platelet count. Participants with a Baseline actual body weight of greater than equal to (>=) 77 kg and Baseline platelet count of >=150,000/ microliter (μL) will take 300 mg/day (3X100mg) at each dose administration. Participants with a Baseline actual body weight of less than (<) 77 kg and/or Baseline platelet count of <150,000/μL will take 200 mg (2X100 mg) at each dose administration.
15942149|NCT03325491|Dietary Supplement|Placebo|Alternate unilateral resistance and aerobic exercise training will also be performed 5 times per week for 6 weeks.
15942510|NCT03322670|Other|Signs of CAP and a negative chest X-Ray|"collection of clinical examination data
~telephone contact on day 28"
15942060|NCT03326193|Biological|Bevacizumab|Maintenance bevacizumab 15 mg/kg will be administered via a 30-minute IV infusion on Day 1 of every 21-day cycle in the absence of progressive disease (PD), unacceptable toxicity, participant withdrawal, Investigator's decision, or death. Bevacizumab will be administered for up to 10 months during the maintenance phase or up to a total of 15 months inclusive of approximately 5 months of bevacizumab received with chemotherapy.
15942061|NCT03326180|Drug|Liposomal bupivacaine|266mg/20ml vial of EXPAREL
15942062|NCT03326180|Drug|Bupivacaine hydrochloride|100mg/20ml 0.5% bupivacaine hydrochloride. Branded or generic, must be plain (cannot contain adrenaline/epinephrine)
15942063|NCT03326167|Other|Myocardial Perfusion Imaging by Single Photon Emission Computed Tomography (MPI SPECT)|Evaluation of the improvement of the sensitivity, in tri-truncular patients, provided by the estimation of the coronal reserve by territory, during the realization of a myocardial perfusion tomoscintigraphy on CZT camera dedicated to cardiology (Discovery NM 530 ).
15942064|NCT03326154|Other|No intervention, observational|Observation
15942065|NCT03326141|Behavioral|Otago Exercise Program|The program has been adapted for groups and includes 5 flexibility movements (e.g., back extension and ankle, head, neck, trunk movements), 5 leg strengthening exercises (knee extensor, knee flexor, hip abductor, ankle plantar flexes, ankle dorsiflexes), 12 balance movements (knee bends, backwards walking, walking and turning, sideways walking, tandem stance, tandem walk, one leg stand, heel walking, toe walking, heel-toe walking backwards, sit to stand, stair walking), and a walking plan. The number, intensity and duration of movements are individualized according to preference and ability and they are gradually progressed.
15942066|NCT03326141|Device|Physical activity monitors (e.g., Fitbit)|We will use Fitbit Charge 2 (or an equivalent). Features essential for this research include built-in accelerometers that accurately measure steps and physical activity (PA) duration.Participants will have a brief orientation to these during baseline data collection and have the opportunity to return demonstrate. In addition, RAs will be available to help participants troubleshoot, as needed, via telephone and in person, after intervention meetings. Intervention meetings include discussions about the PAMs, but topics vary according to assigned study condition.
15942067|NCT03326141|Behavioral|Interpersonal Behavior Change Strategies|The interpersonal content will include facilitated discussed about including PA into social routines, identifying and problem-solving social and environmental barriers to PA, social support for exercise, and friendly social comparisons about practicing PA outside the small group setting and interpreting/ sharing data.
15942068|NCT03326141|Behavioral|Intrapersonal Behavior Change Strategies|The intrapersonal content will include encouragement and guidance to identify baseline PA patterns, develop and refine personally meaningful goals and plans, identify and problem solve personal barriers to staying physically active, integrate PA into personal routines, and monitor goal outcomes
15942069|NCT03326141|Other|Information about Health and Wellness|Information about health and wellness varies in dose, according to time spent in each condition that addresses behavior change. Topics in condition 1 include sleep, vaccinations, supplements, fall risk factors, memory, hearing and pain guided by information for older adults available on the NIA and CDC websites. Topics in conditions 2 and 3 include fall risk factors and sleep. Topics in condition 4 include fall risk factors.
15942070|NCT03326128|Drug|Bupropion hydrochloride extended release|Antidepressant that is also effective in smoking cessation
15942071|NCT03326115|Behavioral|Peer Visitation Program|The Amputee Coalition's Peer Visitation Program (PVP) trains amputee peer supporters to properly navigate a new or less-experienced amputee through the process of rehabilitation. Peer support plays an important role, following the amputation of a limb, by allowing patients to meet other amputees and discuss lifestyle changes post-amputation. Subjects randomized to the PVP group will receive the intervention (visitation by a Certified Peer Visitor) immediately at amputation. Subjects randomized to the non-PVP group will not receive CPV visits immediately at amputation. Rather, they will receive delayed PVP intervention beginning 60 days after amputation and lasting a total of 60 days (or at 120 days post-amputation).
15942072|NCT03326102|Drug|DHP107|DHP107 200mg/m2 orally twice daily on Days 1, 8 and 15 every 28 days
15942073|NCT03326102|Drug|IV Paclitaxel|IV Paclitaxel 80 mg/m2 QW (3 weeks on/1 week off)
15942074|NCT03326089|Procedure|Pulmonary rehabilitation|Endurance training for 30 minutes, 3 times/week for 2 months followed by resistance training
15942075|NCT03326076|Diagnostic Test|Donor-derived cell-free DNA (AlloSure®)|Patients will receive donor-derived cell-free DNA testing for surveillance and for-cause. The planned surveillance will occur at months 1, 2, 3, 4, 6, 9, and 12 post-transplant and quarterly in year 2 and year 3.
15942076|NCT03326076|Other|Standard care|Current standard methods for monitoring of renal allograft recipients for rejection (e.g. donor-specific antibodies, serum creatinine, proteinuria, renal allograft biopsy)
15942077|NCT03326076|Diagnostic Test|Peripheral blood gene expression profiling (AlloMap Kidney)|Patients will receive peripheral blood gene expression profiling testing for surveillance and for-cause. The planned surveillance will occur at months 1, 2, 3, 4, 6, 9, and 12 post-transplant and quarterly in year 2 and year 3.
15942078|NCT03326076|Diagnostic Test|Analytic platform (IBox)|Patients will receive IBox testing for surveillance and for-cause. The planned surveillance will occur at months 1, 2, 3, 4, 6, 9, and 12 post-transplant and quarterly in year 2 and year 3.
15942079|NCT03326063|Drug|Ifetroban|4-week, double-blind, placebo-controlled parallel-design trial of oral ifetroban (a TP receptor antagonist) in patients with AERD
15942080|NCT03326063|Drug|Placebo|4-week, double-blind, placebo-controlled parallel-design trial of oral ifetroban (a TP receptor antagonist) in patients with AERD
15942081|NCT03326050|Drug|Gemifloxacin|Gemifloxacin 320Mg Oral Tablet once daily
15942082|NCT03326050|Drug|Ciprofloxacin|cipro 750 tablet twice daily
15942083|NCT03326050|Drug|Rifampicin|Rifampicin 150Mg Capsule twice daily
15942084|NCT03326037|Genetic|Genotyping of the NPHS2 variant rs61747728|Genotyping of the NPHS2 variant rs61747728 will be performed by Real-time TaqMan Allelic Discrimination Assay (Life technologies, CA, USA) according to standard manufacturer protocols. Allelic discrimination analysis will be performed and analyzed using ABI 7500 Fast Real-time PCR system SDS software (Life technologies, CA, USA)
15942182|NCT03325283|Device|ProtEmbo Cerebral Protection System|A catheter-based embolic deflection device will be positioned in the arch of the aorta to prevent debris liberated during the TAVR procedure from entering the three major vessels of the aortic arch.
15942511|NCT03322657|Drug|Neostigmine|Neostigmine injection
15942085|NCT03326011|Device|Samsung Hip Assist v1|All subjects receive gait training 3 times per week for 8 weeks for 24 training sessions. Each session is directed by a licensed physical therapist and lasted 60 min including rest period of 10 min. Brain activity and gait assessment is performed at visits 0 (baseline), 24 (post-test), and at 3 months (follow-up) after training.
15942086|NCT03325998|Device|Samsung Hip Assist v1|All subjects receive gait training 3 times per week for 8 weeks for 24 training sessions. Each session is directed by a licensed physical therapist and lasted 60 min including rest period of 10 min. Brain activity and gait assessment is performed at visits 0 (baseline), 24 (post-test), and at 3 months (follow-up) after training.
15942087|NCT03325985|Behavioral|Nurse-led telephonic case management|Telephonic meetings with a palliative care nurse. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
15942088|NCT03325985|Behavioral|Facilitated,outpatient specialty palliative care|In-person palliative care visits with a palliative care provider. Palliative care is specialized medical care focused on providing a personalized layer of support dedicated to helping patients and their families cope with a serious illness.
15942089|NCT03325972|Drug|Dexmedetomidine|The drug will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
15942090|NCT03325972|Other|Placebo Saline|Placebo will be administered with a loading dose of 0.5 mcg/kg given over 20 min followed by an infusion at 0.6 mcg/kg/hr. The infusion will be stopped during closure of the fascia.
15942091|NCT03325959|Device|Hyperbaric oxygen therapy|60 HBOT sessions at 2 ATA 100% oxygen
15942092|NCT03325959|Drug|Cymbalta / lyrica|one of the two medications currently licensed for the treatment of FMS in Israel, i.e. Cymbalta and Lyrica.
15942093|NCT03325959|Device|Crossover Hyperbaric oxygen therapy|60 HBOT sessions at 2 ATA 100% oxygen after crossover
15942094|NCT03325946|Behavioral|ACQUIRE Therapy|Intensive therapy services combined with operant conditioning during treatment delivered by trained OT or PTs
15942095|NCT03325933|Other|High Load/Low Rep Resistance Training|Participants will be prescribed High Load/Low Rep resistance training.
15942096|NCT03325933|Other|Low Load/High Rep Resistance Training|Participants will be prescribed Low Load/High Rep resistance training.
15942097|NCT03325920|Device|DIABRUX|All participants receive an individually fabricated diagnostic plate, viz the DIABRUX, for the upper or lower jaw to be worn for five consecutive nights. After use a newly developed analyzing software quantifies the abrasion on the diagnostic plate, thus resulting in a score, viz the Pixel score. This represents a quantitative measure of sleep bruxism activity.
15942098|NCT03325907|Device|navigational template|The navigational template was created based on computed tomography data using three-dimensional technology.
15942099|NCT03325894|Drug|SHP465|SHP465 capsule will be administered in a dose of 6.25 mg orally once daily for 360 days.
15942100|NCT03325881|Drug|SHP465|SHP465 capsule 6.25 mg orally once daily for 4 weeks
15942101|NCT03325881|Drug|Placebo|Placebo matching to SHP465 capsule orally once daily for 4 weeks
15942102|NCT03325868|Drug|Ulipristal Acetate|Ulipristal 5mg daily by mouth for 12 weeks
15942103|NCT03325855|Other|None - Observational|None - Observational
15942105|NCT03325816|Drug|Nivolumab|Nivolumab is administered intravenously
15942106|NCT03325816|Radiation|177Lu-DOTA0-Tyr3-Octreotate|"177Lu-DOTA0-Tyr3-Octreotate will be administered every 8 weeks. The first dose of 177Lu-DOTA0-Tyr3-Octreotate will be given two weeks after the first administration of nivolumab. Each dose is infused over 30 minutes. On the day of 177Lu-DOTA0-Tyr3-Octreotate infusion, an intravenous bolus of anti-emetics will be given (suggested options: ondansetron (8 mg), granisetron (3 mg), or tropisetron (5 mg)). Administration of 177Lu-DOTA0-Tyr3-Octreotate may be given one day earlier or delayed up to 1 week due to holidays, inclement weather, conflicts, or similar reasons.
~Concurrent amino acids are given with each dose of 177Lu-DOTA0-Tyr3-Octreotate since co-infusion of amino acids leads to a significant reduction (47%) in the mean radiation dose to the kidneys. The amino acid solution and 177Lu-DOTA0-Tyr3-Octreotate are administered in parallel by peripheral vein infusion"
15942107|NCT03325803|Drug|lidocaine/prilocaine (5%) application|For AFL pre-treatment, lidocaine/prilocaine (5%) cream (EMLA; Astra Pharmaceuticals, LP, Westborough, MA, USA) was applied to the treatment area under occlusion for 30 min
15942108|NCT03325803|Device|2940-nm Er:YAG AFL pretreatment|After the anaesthetic cream was removed, AFL therapy was performed using a 2940-nm Er:YAG AFL (Joule; Sciton Inc., Palo Alto, CA, USA) at 150 µm ablation depth, level 1 coagulation, 22% treatment density and a single pulse
15942109|NCT03325803|Drug|MAL application|Immediately after AFL treatment, an approximately 1- mm-thick layer of MAL (Metvix, PhotoCure ASA, Oslo, Norway) was applied to the lesion and on 5 mm of surrounding normal tissue. Incubation time is 3 hours
15942110|NCT03325803|Other|Measurements of the fluorescence intensity|After 3 hours of application with MAL, saline wash was performed and fluorescence imaging analysis was performed with ultraviolet examination light (model 31602,356 nm; Burton Medical Products Crop.) at 10 cm height above the base of each lesion. The red fluorescence (610 nm-700 nm) was separated and extracted by Matlab program and then used to measure the amount of 633 nm fluorescence of protoporphyrin IX.
15942111|NCT03325803|Device|irradiation with red light-emitting diode lamp|After incubation for 3 hours, the dressing and cream were removed, and the area was cleansed with saline. The area was irradiated with a red light-emitting diode lamp (Aktilite CL 128; PhotoCure ASA, Oslo, Norway) with peak emission at 632 nm, placed 5 cm away from the skin surface, and a total light dose of 37 J/cm-2. All patients wore protective goggles during illumination.
15942112|NCT03325790|Drug|200mg SPI-1005 BID|Active: low dose
15942113|NCT03325790|Drug|400mg SPI-1005 BID|Active: high dose
15942114|NCT03325790|Other|Placebo|Placebo Comparator
15942183|NCT03325270|Dietary Supplement|labeled ferrous fumarate|labeled iron as Ferrous Fumarate
15942184|NCT03325270|Dietary Supplement|labeled ferrous fumarate + prebiotics|labeled iron as Ferrous Fumarate + galacto-oligosaccharides
15942185|NCT03325270|Dietary Supplement|labeled ferrous sulfate + prebiotics|labeled iron as Ferrous Sulfate + galacto-oligosaccharides
15942512|NCT03322657|Drug|Glycopyrrolate|Glycopyrrolate injection
15942513|NCT03322657|Drug|Sugammadex|Sugammadex injection
15942115|NCT03325777|Behavioral|Approach Bias Retraining|The Approach Avoidance Task (AAT) used for this experiment is an implicit, computerized paradigm in which participants respond to visually presented pictures on a computer screen displaying either 1) smoking-related images or 2) positive images, by pulling a joystick either towards their body (approach movement) or pushing it away from their body (avoidance movement). By pulling the joystick towards their body, the picture grows in size; by pushing the joystick away, the picture shrinks and then disappears from the screen. Participants are instructed to pull upon seeing an image tilted to the right and to push upon seeing a left-tilt image, while ignoring the image content and responding as quickly and as accurately as possible.
15942116|NCT03325777|Behavioral|SHAM Training|SHAM Training
15942117|NCT03325764|Other|functional assessment|assessment of functional capacity, habitual physical, cardiorespiratory fitness, muscle power and postural stability and gait parameters
15942118|NCT03325751|Diagnostic Test|Visual field testing|Standard Automated Perimetry using a perimeter is one of the most commonly used techniques for measuring perceived visual ability of a subject. For a given eye, it provides quantitative measurements of visual function represented as a 2D spatial visual field map. It is of great clinical importance for diagnosing and monitoring glaucoma and detecting neurological conditions.
15942119|NCT03325725|Device|NewBreez LD intra-laryngeal implant|NewBreez LD intra-laryngeal implantation
15942120|NCT03325712|Drug|BI 705564|Film-coated tablet
15942121|NCT03325712|Drug|Placebo|Film-coated tablet
15942122|NCT03325699|Device|SMART4MD Health Application|"SMART4MD is a general health application which has been adapted specifically for people with mild dementia through a structured process. The application is intended to be used daily at home, mainly by the participants themselves, with the help of their informal carers. The application is optimized for tablet devices running on Android operating system (OS). Participants will be provided with a tablet with the SMART4MD health application.
~The core functionalities of the application are based on reminders (medication, appointments with healthcare providers), brain supporting activities (clock, calendar, brain games, photos) and optional status and health information sharing with family and informal carers (including daily feeling status, specific health problems, and quality of life). An important feature of SMART4MD is its personalization facility: main users (PWD and informal carers) will be able to switch off/on various features and information sharing possibilities."
15942123|NCT03325686|Dietary Supplement|vitamin D supplement|D; received 50,000 IU of vitamin D supplement weekly
15942124|NCT03325686|Other|Placebo|placebo
15942125|NCT03325673|Device|TrueTear|TrueTear Device (Intranasal Tear Neurostimulator) was used intranasally on CL wear days; it was also used on non-CL wear days if the participant chose. The number of applications was determined by participant.
15942126|NCT03325673|Device|TrueTear Sham Control|TrueTear sham device, which is not electrically active and has limited tip insertion depth, was used intranasally on CL wear days; it was also used on non-CL wear days if participant chose. The number of applications was determined by participant.
15942127|NCT03325660|Other|whole body vibration|pelvic floor exercises
15942128|NCT03325647|Drug|Testosterone Cypionate 200 Milligram/Milliliter Injectable Solution|Subjects in one arm will be randomized to receive testosterone cypionate 200 mg/ml intramuscularly every 4 weeks for a total of three doses after visit 1, and receive placebo injectable saline for the same duration starting at visit 2. Subjects in the other arm will be randomized to receive placebo injectable saline every 4 weeks for a total of 3 doses after visit 1, and testosterone cypionate 200 mg/ml intramuscularly for the same duration starting at visit 2.
15942129|NCT03325647|Drug|Placebo injectable saline|Subjects in one arm will be randomized to receive testosterone cypionate 200 mg/ml intramuscularly every 4 weeks for a total of three doses after visit 1, and receive placebo injectable saline for the same duration starting at visit 2. Subjects in the other arm will be randomized to receive placebo injectable saline every 4 weeks for a total of 3 doses after visit 1, and testosterone cypionate 200 mg/ml intramuscularly for the same duration starting at visit 2.
15942130|NCT03325634|Other|Laboratory Biomarker Analysis|Correlative studies
15942131|NCT03325634|Other|Quality-of-Life Assessment|Ancillary studies
15942132|NCT03325634|Other|Questionnaire Administration|Ancillary studies
15942133|NCT03325634|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15942134|NCT03325621|Biological|PRS-080#022-DP|Biological/Vaccine: PRS-080#022-DP Hepcidin antagonism to mobilize iron and to treat anemia
15942135|NCT03325621|Biological|PRS-080-Placebo#001|Placebo Comparator
15942136|NCT03325608|Other|POISED Care|Using information collected, a propose plan of care and tailored interventions to the patients. Patients will understand natural history, and the prognosis of dementia; care protocols will be implemented.
15942137|NCT03325608|Other|Usual Care|Usual care group will not receive the POISED structured assessment, attention to chronic disease management, or RCA related to the ED visit.
15942138|NCT03325595|Drug|AEF0117|0.2, 0.6, 2, or 6mg of AEF0117
15942139|NCT03325595|Drug|Placebo|Matching capsule placebo
15942140|NCT03325569|Diagnostic Test|oral glucose tolerance test|GLP1 response to oral glucose load during oral glucose tolerance test was assessed.
15942141|NCT03325556|Drug|Placebo|Placebo, tablets, once daily by mouth
15942142|NCT03325556|Drug|Pimavanserin 34 mg|Pimavanserin 34 mg total daily dose, tablets, once daily by mouth
15942143|NCT03325556|Drug|Pimavanserin 20 mg|Pimavanserin 20 mg total daily dose, tablets, once daily by mouth
15942144|NCT03325543|Other|Verbal instruction and Vaginal palpation|The experimental group will receive verbal instructions on the anatomy and function of PFMs associated with the use of body awareness techniques and vaginal palpation to learn the correct PFMs contraction. The control group will receive only verbal instructions on the anatomy and function of PFMs associated with the use of body awareness techniques.
15942145|NCT03325530|Behavioral|Focus Group with Participants|Focus groups with leaders (18+) to investigate tolerance to healthy initiatives
15942146|NCT03325504|Biological|Cultured Mesenchymal Stem Cells|Cultured Mesenchymal Stem Cells obtained from expanded bone marrow
15942147|NCT03325504|Procedure|Autologous iliac crest graft|Autologous iliac crest grafting
15942148|NCT03325491|Dietary Supplement|Acipimox|Acipimox plus exercise training: Oral supplement containing Acipimox 250mgs as the active ingredient in blinded label tablet form.
15942230|NCT03324932|Drug|Denosumab Injection|AI intake + denosumab injection per 6 months VS only AI intake
15942150|NCT03325478|Other|"Over the phone interviews on the BCI Stay in Contact"|"This study used phone call interviews on a BCI Stay in Contact, 6 months after suicide attempt behavior.The questionnaire used for the interview of included suicide attempters was pilot tested to assess acceptability and feasibility of the study. It included 24 questions, which were based on literature's data.They covered seeking care and help items and assess the subjective quality appreciation of medical care in the PED and on the BCI.Closed-ended and multiple-choice questions were mixed. Included patients were informed that the questionnaire was anonymous and that seeking their views and feedbacks would help adjusting the implementation of follow-up interventions closer to their needs.The baseline interviews were conducted on the phone, on weekdays, during a mean time of 10 to 15minutes by a trained resident in psychiatry as the only interviewer."
15942151|NCT03325465|Drug|Pembrolizumab|Patients will receive pembrolizumab alone or pembrolizumab in combination with epacadostat. Pembrolizumab will be administered at 200 mg IV every 3 weeks for up to 3 doses for no longer than 8 weeks prior to surgery. After surgery, patients will continue pembrolizumab plus epacadostat every 3 weeks for 12 months.
15942152|NCT03325465|Drug|Epacadostat|Patients will receive epacadostat in combination with pembrolizumab. Epacadostat will be administered orally at a dose of 100 mg twice a day starting on day 1 for the duration of pembrolizumab treatment. Patients will continue on this combination for no longer than 8 weeks prior to surgery. After surgery, patients will continue pembrolizumab plus epacadostat every 3 weeks for 12 months.
15942153|NCT03325452|Biological|venous lactate|value of venous lactate
15942154|NCT03325439|Drug|Brivaracetam (BRV) intravenous (iv)|"Exploratory Cohort:
~Subjects will be dosed with BRV (0.5 mg/kg twice daily (bid)) according to the sites standard procedures. Treatment with 1 or more of the following antiepileptic drugs (AEDs): phenobarbital (PB), midazolam (MDZ), phenytoin (PHT), levetiracetam (LEV), or lidocaine (LDC) (first-line, second-line, or subsequent treatment) will continue in parallel with BRV treatment.
~Confirmatory Cohort:
~For subjects who enter the Confirmatory Cohorts, for the strength of BRV 1 mg/kg bid (2 mg/kg/day) has been determined based on the Pharmacokinetic (PK) findings of the Exploratory Cohort. Based on further monitoring of PK and safety findings dosing may be adjusted as new data are available. Administration of BRV is proposed as approximately 15-minute intravenous (iv) infusions. Treatment with previous antiepileptic drugs is permitted to continue if the subject is on a stable dose from 1 hour prior to initiation of the BRV treatment."
15942155|NCT03325439|Drug|Brivaracetam (BRV) oral|Subjects can switch from intravenous (iv) to oral brivaracetam (BRV) at any time during the BRV Extension Period
15942156|NCT03325426|Device|FitBit|Daily use of physical activity tracker coupled with biweekly provider telemonitoring and feedback for 6 months
15942157|NCT03325413|Behavioral|Systematic inclusion of family members|Systematic inclusion of family members/ reference person in the perioperative process
15942158|NCT03325413|Behavioral|Preoperative information|Detailed preoperative information about delirium prevention and procedures
15942159|NCT03325413|Behavioral|Physical and breathing exercises|Preoperative execution of physical and breathing exercises if necessary
15942160|NCT03325413|Dietary Supplement|Dietary supplements|Dietary supplements if necessary
15942161|NCT03325413|Other|Evaluation of long-term medication|Avoidance of unsuitable drugs for elderly if possible
15942162|NCT03325413|Procedure|Regional anesthesia|Regional anesthesia whenever possible
15942163|NCT03325413|Other|Personal aids|Personal orientation aids until anesthesia induction
15942164|NCT03325413|Device|Temperature management|Perioperative warming
15942165|NCT03325413|Device|Neurmonitoring|Using Bispectral index (BIS) to measure the depth of anesthesia
15942166|NCT03325413|Procedure|Pain catheter|A pain catheter will be used as postoperative pain therapy if possible
15942167|NCT03325400|Other|Toothpaste non-fluoride and fluoride|"Participants have used toothpaste for four months. The first two months they used non-fluoride toothpaste, after which, for the next two months, they used toothpaste containing fluoride of the same manufacturer and similar composition. The tested kinds of toothpaste were applied twice a day, in the morning and evening, for three minutes in the amount of 1 g (≈2 cm).
~Participants have used toothpaste for four months. The first two months they used non-fluoride toothpaste, after which, for the next two months, they used toothpaste containing fluoride of the same manufacturer and similar composition. The tested kinds of toothpaste were applied twice a day, in the morning and evening, for three minutes in the amount of 1 g (≈2 cm). Contemporary, participants did not use other agents for oral hygiene such as mouthwash or topical fluoridation."
15942168|NCT03325387|Drug|LY3305677|Administered SC
15942169|NCT03325387|Drug|Placebo|Administered SC
15942170|NCT03325374|Other|Questionnaires and examination|Patients with in the BLB patients study will have interview and questionnaire carried out.
15942171|NCT03325361|Other|Tube drain insertion|A de-Pezzer catheter was placed transanally after the creation of the anastomosis, secured to the buttocks, and connected to a urine bag to allow monitoring the amount and the color of the drainage. The catheter was removed on the 3rd day postoperative if the volume collected was insignificant.
15942172|NCT03325348|Drug|Nifedipine 10 mg|Nifedipine 10mg oral tablet with 1 ml 0.9% n/saline will be given to patients every 15 min uptil one hour
15942173|NCT03325348|Drug|Labetalol|IV labetalol 20 mg & mint tablet will be given to patients every 15 min until one hour
15942174|NCT03325335|Drug|Midazolam premedication|Patients in Group P received midazolam (0.05 mg/kg, intramuscular injection) 30 minutes before induction of general anesthesia.
15942175|NCT03325335|Drug|Remifentanil infusion|Target controlled infusion of remifentanil (4ng/ml) was used for induction of anesthesia based on the pharmacological models of Minto. After intubation, remifentanil (2 ng/ml) was infused until incision time. (Both groups)
15942176|NCT03325335|Drug|Propofol infusion|Target controlled infusion of propofol (4.0 μg/ml) was used for induction of anesthesia based on the pharmacological models of Marsh. After intubation, propofol (3.0μg/ml) was infused until incision time. (Both groups)
15942177|NCT03325322|Dietary Supplement|Fisetin|Flavonoid family
15942178|NCT03325322|Drug|Placebo oral capsule|Placebo
15942179|NCT03325309|Other|Home-based cycling|A single outpatient supervised session followed by a 3-month home-based cycling program tailored to patients' preferences
15942180|NCT03325296|Drug|LEO 124249|Ointment containing LEO 124249
15942181|NCT03325296|Other|Ointment vehicle|Ointment without active ingredients
15976836|NCT03060798|Drug|Desflurane|general anesthesia using desflurane.
15942186|NCT03325257|Other|Routine care|This study is an observational one - there is no change to the routine care. Patients received the Nivolumab independently of the study. Only data will be collected during this project.
15942187|NCT03325244|Other|EEG monitor|sleep patterns will be monitored using EEG monitor
15942188|NCT03325244|Other|FitBit|activity levels will be monitored
15942189|NCT03325231|Other|Reconstructive surgery following bladder removal.|Investigating patient experience of bladder reconstructions.
15942190|NCT03325205|Other|Anodal tDCS|Anodal Transcranial direct current stimulation (tDCS) is a non- invasive brain stimulation technique. Low intensity current (1-2 mA) is induced to increase excitability, stimulate plasticity and enhance cognitive functions.
15942191|NCT03325205|Other|Sham tDCS|The electrodes are placed over the same areas as in the anodal tDCS condition. Participants will receive sham tDCS instead of anodal tDCS
15942192|NCT03325192|Drug|Rapid pleurodesis protocol|"The pleural space will be evacuated completely through the newly placed IPC
~20mL of 10% iodopovidone and 80mL of normal saline will be instilled into the pleural space
~The patient will be transferred to the recovery unit
~Two hours after instillation the pleural space will be drained
~After recovery from anesthesia and complete drainage of the pleurodesis mix, the subject will be discharged
~Subjects will be asked to drain their effusion on a daily basis for the next 7 days and then on an every other day basis."
15942193|NCT03325192|Other|Placebo|"The pleural space will be evacuated completely through the newly placed IPC
~Only placebo (normal saline) will be instilled into the pleural space
~The patient will be transferred to the recovery unit
~Two hours after instillation the pleural space will be drained
~After recovery from anesthesia and complete drainage of the pleurodesis mix, the subject will be discharged
~Subjects will be asked to drain their effusion on a daily basis for the next 7 days and then on an every other day basis."
15942194|NCT03325179|Other|Thread-embedding Therapy|
15942195|NCT03325166|Drug|Ferumoxytol|Given IV
15942196|NCT03325166|Other|Laboratory Biomarker Analysis|Correlative studies
15942197|NCT03325166|Procedure|Magnetic Resonance Imaging|Undergo MRI
15942198|NCT03325166|Biological|Pembrolizumab|Given IV
15942199|NCT03325127|Drug|radium Ra 223 dichloride (Xofigo, BAY88-8223)|Radium-223, 55kBq (1.49 microcurie) per kg body weight given at 4 week intervals for 6 injections
15942200|NCT03325127|Drug|Zytiga|Abiraterone 1000 mg per day orally
15942201|NCT03325127|Drug|Xtandi|Enzalutamide 160 mg per day orally
15942202|NCT03325114|Drug|Chlorthalidone|Chlorthalidone 12.5-5 mg by mouth daily for 4 weeks
15942203|NCT03325101|Procedure|Cryosurgery|Undergo cryosurgery
15942204|NCT03325101|Biological|Pembrolizumab|Given IV
15942205|NCT03325101|Procedure|Pheresis|Undergo apheresis
15942206|NCT03325101|Biological|Therapeutic Autologous Dendritic Cells|Given IT
15942207|NCT03325088|Procedure|Bronchial endoscopy|Bronchial endoscopy will be performed after clinical examination and pulmonary function tests
15942208|NCT03325088|Procedure|Bronchial biopsies|5 biopsies will be done and analysed at the end of recruiting to assess monomeric GTP Rac1 protein expression and activity on bronchial biopsies
15942209|NCT03325088|Procedure|Bronchial alveolar enema|For participants who had signed ancillary research consent
15942210|NCT03325075|Biological|VAL-181388|Escalating dose levels
15942211|NCT03325075|Other|Placebo|Saline
15942212|NCT03325062|Behavioral|MOVE|The MOVE program emphasizes movement pattern retraining in conjunction with contemporary rehabilitation. More specifically, the MOVE program promotes symmetry in functional knee motion and loading without postural compensation. Intervention uses pressure-sensing shoe insoles to deliver real-time visual biofeedback during activity performance.
15942213|NCT03325062|Behavioral|Control|The contemporary progressive rehabilitation program consists of progressive resistive exercise to key lower extremity muscle groups, knee range of motion exercise, weight-bearing exercise, as well as education on symptom management strategies.
15942214|NCT03325049|Behavioral|The health-promoting conversations|The health-promoting conversations
15942215|NCT03325049|Other|Usual Care|Usual Care
15942216|NCT03325036|Diagnostic Test|Serum levels of immunologic profiles|Serum levels of immunologic profiles before and after chemoradiotherapy
15942217|NCT03325023|Dietary Supplement|Dietary and life style modification and probiotic Sanprobi Super Formula|Sanprobi Super Formula consisting of: Bifidobacterium lactis, Lactobacillus acidophilus, Lactobacillus paracasei, Lactobacillus plantarum, Lactobacillus salivarius, Lactobacillus lactis, Fructooligosacharide, Inulin.
15942218|NCT03325023|Other|Placebo|Placebo
15942219|NCT03325010|Drug|Valbenazine|vesicular monoamine transporter 2 (VMAT2) inhibitor
15942220|NCT03325010|Drug|Placebo oral capsule|non-active dosage form
15942221|NCT03324997|Drug|Restylane Silk|Restylane Silk is a temporary hyaluronic acid filler currently approved for the lips and fine lines around the mouth.
15942222|NCT03324997|Drug|Saline|Saline as placebo
15942223|NCT03324997|Device|Optical Coherence Tomography|An FDA-cleared non-invasive imaging device
15942224|NCT03324984|Drug|1% chloroprocaine|In 2018, 1% Chloroprocaine was approved by the FDA for spinal anesthesia use.
15942225|NCT03324984|Drug|0.75% bupivacaine|Bupivacaine is used on label
15942226|NCT03324971|Other|Medications review|"Medications review. Elimination of all unnecessary prescription to cut down the number of medications to the least possible number.
~This is in line with the best practice guidelines."
15942227|NCT03324958|Device|Virtual reality Helmet|The virtual reality helmet will be installed by a radiotherapist or a radiotherapy manipulator, just before the intra vaginal applicator. The virtual reality headset will be connected to a dedicated computer. The virtual reality program will run for 10 minutes which will cover the entire procedure for setting up the brachytherapy device. In order to optimize the distractive potential of virtual reality, four different virtual reality programs will be offered to patients during each brachytherapy fraction. These programs will be contemplative so as not to compromise the immobility of the patients during the installation of the brachytherapy applicator.
15942228|NCT03324958|Other|No Virtual Reality Helmet|The radiotherapists can freely dialogue with the patients during the brachytherapy applicator' seating up, as in current practice.
15942229|NCT03324945|Behavioral|Neurocognitive assessments|Baseline and post-chemotherapy neurocognitive testing. A sequentially-assigned subset of participants also receive baseline and post-chemotherapy neuroimaging (FMRI)
15942231|NCT03324919|Behavioral|HRQL|Intervention of patient centered care situation and health-related quality of life of patients with Psoriasis, Urticaria or Lupus erythematodes from non-urban practices vs urban practises. Identification of relevant health-related quality of life parameters of these patients.
15942232|NCT03324906|Device|tDCS|The anode will be placed in the left side of DLPFC (F3) of the International Electrode Placement System 10-20 and cathode will be placed in the same region of the contralateral cortex, corresponding to the area F4. The stimulation current will be 2mA (for individuals aged 14-35 years) and 1mA (for individuals aged 11 to 13 years, maintaining this intensity until the end of the stimulation), will last for thirty seconds, and the ramp will exit fifteen seconds. The stimulation will last for up to 20 minutes, for a total of 10 sessions, one a day for twice a week with a weekend break.
15942233|NCT03324893|Diagnostic Test|[F-18]-FCH PET/MRI|Subjects will undergo the [F-18]-FCH PET/MRI within three months prior to scheduled parathyroidectomy.
15942234|NCT03324880|Biological|rhPTH(1-84)|rhPTH(1-84) 25, 50, 75, and 100 mcg QD SC injection will be administered
15942235|NCT03324880|Biological|Placebo|Placebo QD SC injection will be administered
15942236|NCT03324867|Drug|Regular insulin|40 IU of Humulin-R to be administered via nose using metered nasal dispenser prior to surgery, and up to 7 days after surgery.
15942237|NCT03324867|Drug|Normal Saline Flush, 0.9% Injectable Solution|Placebo: Normal Saline to be administered via nose using metered nasal dispenser prior to surgery, and up to 7 days after surgery
15942238|NCT03324854|Procedure|Rives technique|Open ventral hernia repair followed by the placement of the mesh.
15942239|NCT03324854|Procedure|Drainage|Placement of active-close drainage in surgical site.
15942240|NCT03324854|Drug|Prophylactic|Prophylactic antibiotic 1gm of cefalotin was administered 30 minutes before the incisión.
15942241|NCT03324841|Diagnostic Test|Caris MI Profiling|Customized comprehensive biomarker testing
15942242|NCT03324828|Drug|Hydroxyzine|Hydroxyzine solution
15942243|NCT03324828|Other|Clowns intervention|Clowns intervention
15942244|NCT03324815|Drug|Morphine|Pain Treatment
15942245|NCT03324815|Drug|Methadone|Pain Treatment
15942246|NCT03324802|Radiation|Hypofractionated Radiation Therapy|Undergo hypofractionated radiation therapy
15942247|NCT03324802|Other|Quality-of-Life Assessment|Ancillary studies
15942248|NCT03324802|Radiation|Radiation Therapy|hypofractionated radiation therapy
15942249|NCT03324789|Other|Single Implant Partial Over-denture|Single Implant Retained Partial Over-denture will be as follows; two rests on principle abutments and lingual plate major connector, single implant in the symphyseal region.
15942250|NCT03324789|Other|Conventional Partial Denture|patients will receive conventional partial denture with double Aker clasp on mandibular second premolar and first molar, with no indirect retention and lingual plate as major connector .
15942251|NCT03324776|Drug|Afrezza Inhalant Product|Mealtime Ultra-Rapid Acting Insulin
15942252|NCT03324763|Other|stool sampling|A stool sample will be collected to perform the H. pylori antigen test
15942253|NCT03324737|Device|Interactive Smartphone App|"There are six main components to the APP.
~Goal Setting: personalizes diet, activity, and weight loss goals for patients based on their starting point.
~Food choices and recommendations: App has an automated and immediate recommendation of foods if the choice selected from food database is not optimal. It has a calorie and nutrients tracker to enable patients to track their food intake.
~Activity and steps tracker: App has a pedometer to count physical activity and steps to enable patients to track their progress towards goals.
~Interactive video lessons: App has video lessons pushed weekly to the patient according to her needs. The videos encompass aspects of diet, lifestyle and behavior management.
~Healthcare Professionals Support: App has a chat channel to enable interaction between participants and healthcare professionals."
15942254|NCT03324724|Behavioral|Integrative cognitive-affective therapy for adolescents (ICAT-A)|Participants will receive a 21-session individual psychotherapy approach with 4 phases. In addition, there will be 7-13 additional conjoint parent sessions.
15942255|NCT03324711|Diagnostic Test|"Antillanisée Mini Mental State Examination (MMSEa)"|"Antillanisée version of the Mini Mental State Examination (MMSEa), is a version adaptated to the French West Indies creole culture."
15942256|NCT03324685|Drug|BIIB074|BIIB074 is administered as specified in the treatment arm.
15942257|NCT03324685|Drug|OC (ethinyl estradiol and levonorgestrel)|OC is administered as specified in the treatment arm.
15942258|NCT03324672|Procedure|TRIGGER|only TRIGGER point will be included for the manual therapy
15942259|NCT03324672|Procedure|TRIGGER+CURETAPE|TRIGGER point will be included for the manual therapy with kinesio-taping
15942260|NCT03324659|Behavioral|Exercise and Meditation|The Exercise and Meditation group will listen to recorded meditations (15 minutes) that are based on mindfulness. They will then walk on a treadmill for 30 minutes at a moderate intensity. The intervention is completed five days per week for four weeks.
15942261|NCT03324659|Behavioral|Control|The Control group will listen to a recorded audio book for 15 minutes, They will then sit quietly for 30 minutes. The intervention is completed five days per week for four weeks.
15942262|NCT03324620|Other|Specific program functional and respiratory rehabilitation|It is a question of introducing a small program of physical activation pre-transplantation of hematopoietic progenitors, to continue developing it during the hospitalization and to use the functional measurements as a measure of its impact, as well as the different quality of life questionnaires.
15942263|NCT03324607|Drug|hyperpolarized 129Xe gas MRI|There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi. Images obtained using 129Xe MRI will be compared with standard lung function tests that are used routinely in the clinic, 6 minute walk test that assesses walking ability and several questionnaires that assess shortness of breath and life quality.
15942264|NCT03324607|Drug|Bevespi Aerosphere|There will be MRI imaging before the treatment with Bevespi and another one 2 weeks after use Bevespi.
15942295|NCT03324386|Behavioral|Experimental: Individual Orientation|This approach may be individual orientation with by an embracement strategy (relational strategies) may be making 7 nursing visits at 20-day intervals, for 4 month.
15942296|NCT03324386|Behavioral|Experimental: VLE for Distance Learning|Experimental: This approach may be associated with the use of educational technology (E-Care of Hypertension) in a virtual learning environment(VLE) for distance learning (DL) consultation with the health professional and making 7 nursing visits at 20-day intervals, for 4 months
15942265|NCT03324594|Device|(1) WONDALEAF-CAP, (2) WONDALEAF-ON-MEN, (3) durex-TOGETHER (active comparator)|"WONDALEAF-ON-MEN (WLM) is a polyurethane pouch with outstretching adhesive shield. The pouch covers the penis in man user; while the adhesive shield covers the groin regions to provide extra protection for the couples. The pouch is equivalent to marketed polyurethane male; while the adhesive shield is equivalent to marketed polyurethane wound dressing. WLM integrally joined with an adhesive wound dressing, both made of the same polyurethane material.
~WONDALEAF-CAP (WLC) is a miniature form of WLM: the pouch covers glans penis and the adhesive shield wraps around the shaft of the penis only, thereby emulating the configuration of a donned regular condom on the penis. Because of the adhesive coating, WLC overcomes the problems of slippage when the penis is flaccid.
~The durex-TOGETHER serves as the active comparator in this study. It is a transparent natural rubber latex male condom which is commercially available."
15942269|NCT03324568|Behavioral|Parent Education Videos|Participants will receive educational videos describing behavioral techniques to improve parent and child eating behavior.
15942270|NCT03324568|Behavioral|Educational Handout|Participants will receive educational handouts describing behavioral techniques to improve parent and child eating behavior.
15942271|NCT03324555|Drug|ORIC-101|Oral suspension
15942272|NCT03324542|Drug|Aflibercept [Eylea]|Anti-vascular endothelial growth factor (VEGF)
15942273|NCT03324529|Device|Tako Breath|Device guided breathing. A medical device with a computerized control unit, a breathing sensor and a set of earphones with audio-prompts to guide breathing at a slow rate (<10 breaths/min) with prolonged exhalation.
15942274|NCT03324516|Procedure|Re-Suspension of the temporal muscle after a craniotomy.|The temporal muscle cuff will be used to re-suspend the temporal muscle after a traditional craniotomy.
15942275|NCT03324516|Procedure|Traditional re-suspension of the temporal muscle|The temporal muscle will be re-suspended to the bone plate that is used to fixate the temporal bone that is removed for the craniotomy.
15942276|NCT03324503|Drug|Glucocorticoid (prednisone or prednisolone)|≥ 30 mg/day prednisone or prednisolone taken orally as per local clinical practice of sarcoidosis initial induction therapy
15942277|NCT03324490|Procedure|Thoracic Spinal Anesthesia|"Spinal anesthesia will be performed for patients of the TSA group at the T7-T8 intervertebral space, using a 27 G pencil point needle with an introducer (Braun Melsungen, Melsungen, Germany).
~When correct placement is confirmed by the free flow of clear CSF, 1.5 ml of hyperbaric Bupivacaine 0.5% (7.5 mg) in addition to 0.5 ml Fentanyl (25 μg) & 5 μg dexmedetomidine will be injected."
15942278|NCT03324490|Procedure|Thoracic Epidural Anesthesia|"Epidural anesthesia will be performed for patients of the TEA group at the T7-T8 intervertebral space, using the Prefix Custom Epidural Anesthesia Tray with an 18 G Tuohy epidural needle & a 20 G epidural catheter.
~Patients will initially receive 5-10 ml of a mixed preparation of 0.5% isobaric Bupivacaine with 2 μg Fentanyl per ml volume as a bolus dose via the epidural catheter, this will be followed by a continuous infusion of 5-10 ml/hr started 1 hour after the bolus dose & continued throughout the procedure."
15942279|NCT03324490|Drug|Bupivacaine 0.5% (hyperbaric)|Neuro-axially injected
15942280|NCT03324490|Drug|Bupivacaine 0.5% (isobaric)|Neuro-axially injected
15942281|NCT03324490|Drug|Fentanyl|Neuro-axially injected
15942282|NCT03324490|Drug|Dexmedetomidine|Neuro-axially injected
15942283|NCT03324477|Drug|hypertonic saline 3%|hypertonic saline 3% is a type of crystalloid solutions with osmolarity higher than that of plasma
15942284|NCT03324464|Behavioral|Central Executive Training: Working Memory|Computerized working memory training
15942285|NCT03324464|Behavioral|Central Executive Training: Inhibitory Control|Computerized inhibitory control training
15942286|NCT03324451|Behavioral|TTM Intervention for Insulin Initiation|The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management. Different intervention strategies are applied to patients according to their stages of change.
15942287|NCT03324451|Behavioral|Usual care|Regular patient education on insulin injection at the control arm hospital.
15942288|NCT03324438|Behavioral|Home Telehealth T1D C2oYoT1-HR|1) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.
15942289|NCT03324438|Behavioral|Personalized Behavioral Health|1) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.
15942290|NCT03324438|Behavioral|Personalized Adherence Feedback|1) assessment of physical and behavioral health characteristics associated with high-risk status; 2) delivery of home telehealth that incorporates: 2a) medical and behavioral health care delivered with the endocrinologist and behavioral health specialist working together with high-risk youth; 2b) personalized intervention to improve T1D adherence and T1D clinical health outcomes; 2c) personalized intervention to improve mental health comorbidities and T1D clinical health outcomes; and 3) an underused methodological approach for optimizing intervention components to be delivered at point of care.
15942291|NCT03324425|Drug|Simvastatin 80mg|Participants will receive simvastatin 80 mg by mouth daily at bedtime
15942292|NCT03324412|Drug|Treatment of MTX|Methotrexate: 10-15mg per week according to patient's weight, oral, for 24 weeks.Tripterygium wilfordii Hook F（TwHF）placebo：20mg， 3 times a day, oral, for 24 weeks.
15942293|NCT03324412|Drug|Treatment of MTX and TwHF|Methotrexate : 10-15mg per week according to patient's weight, oral, for 24 weeks.Tripterygium wilfordii Hook F（TwHF）：20mg， 3 times a day, oral, for 24 weeks.
15942294|NCT03324399|Dietary Supplement|probiotic|a proprietary probiotic formulation
15942297|NCT03324386|Behavioral|Experimental: E-blended Lerarning|This approach may be associated with the use of educational technology (E-Care of Hypertension) in the blended e-learning mode associated with face-to-face with the health professional and making 7 nursing visits at 20-day intervals, for 4 months
15942298|NCT03324386|Other|Conventional Therapy - Control Group|This approach may be individual orientation with conventional therapy may be making 2 nursing visits at baseline and 1 after 120 days,
15942299|NCT03324373|Drug|Lenvatinib|Lenvatinib is a receptor tyrosine kinase (RTK) inhibitor that inhibits the kinase activities of vascular endothelial growth factor (VEGF) receptors VEGFR1 (FLT1), VEGFR2 (KDR), and VEGFR3 (FLT4). Lenvatinib also inhibits other RTKs that have been implicated in pathogenic angiogenesis, tumor growth, and cancer progression in addition to their normal cellular functions, including fibroblast growth factor (FGF) receptors FGFR1, 2, 3, and 4; the platelet derived growth factor receptor alpha (PDGFRα), KIT, and RET.
15942300|NCT03324373|Drug|Everolimus|Everolimus is an inhibitor of mammalian target of rapamycin (mTOR), a serine-threonine kinase, downstream of the PI3K/AKT pathway. The mTOR pathway is dysregulated in several human cancers. Everolimus binds to an intracellular protein, FKBP-12, resulting in an inhibitory complex formation (mTORC1) and thus inhibition of mTOR kinase activity. Everolimus reduced the activity of S6 ribosomal protein kinase (S6K1) and eukaryotic elongation factor 4E-binding protein (4E-BP1), downstream effectors of mTOR, involved in protein synthesis. In addition, everolimus inhibited the expression of hypoxia-inducible factor (e.g., HIF-1) and reduced the expression of vascular endothelial growth factor (VEGF). Inhibition of mTOR by everolimus has been shown to reduce cell proliferation, angiogenesis, and glucose uptake in in vitro and/or in vivo studies.
15942301|NCT03324373|Procedure|Partial or Radical Cytoreductive Nephrectomy|"Surgical removal of a kidney.
~After completion of 8 weeks of therapy and restaging, investigators will require 2 weeks wash out period. The patients will be evaluated by urology oncology team and appropriate surgery will be planned. This includes partial nephrectomy and radical nephrectomy."
15942302|NCT03324360|Drug|Hyperpolarized 13C-Pyruvate|MRI with Hyperpolarized 13C-Pyruvate Injection
15942303|NCT03324347|Procedure|Therapydog|Presence of a therapydog during a clinical examination in a dental clinic
15942304|NCT03324334|Diagnostic Test|Thyroid antibodies|Thyroid antibodies: Antithyroperoxidase(Anti-TPO), Anti-thyroglobulin (anti-TG) to detect graves disease in study and control groups
15942305|NCT03324334|Diagnostic Test|Thyroid sonography|Thyroid sonography to detect anatomical changes in thyroid
15942306|NCT03324321|Other|Hypocapnia via Hyperventilation Protocol|90 seconds of hyperventilation using a metronome to lower levels of -5mmHg and -10mmHg below baseline EtCO2
15942307|NCT03324308|Diagnostic Test|Computed Tomography Angiography|This will be a prospective study comparing the low-dose dynamic vs. static CTP combined with the CTA for detecting hemodynamically significant coronary artery stenosis. Patients will have two 18-20 gauge intravenous lines placed for contrast administration. The following image sequences will be completed: coronary calcium scan (non-contrast), rest coronary arterial imaging (with 4-5 mL/sec intravenous ISOVUE-370 infusion), stress myocardial perfusion imaging 20 minutes after rest acquisition imaging (blood pressure will be checked then an infusion of adenosine will be started for a total of 5 minutes; after 5 minutes of adenosine infusion, CT perfusion imaging will be performed during a 4-5 mL/sec ISOVUE-370 infusion). Total estimated radiation dose: 10.551 mSv.
15942308|NCT03324295|Diagnostic Test|cortical cataract|Blood urea
15942309|NCT03324282|Drug|Avelumab|Combination of Gemcitabin-Cisplatin and avelumab given for 6 cycles (each cycle is 21 days)
15942310|NCT03324282|Drug|GC|Combination of Gemcitabin-Cisplatin given for 6 cycles (each cycle is 21 days)
15942311|NCT03324269|Device|NOL|"After tracheal intubation, a Tetanus test (60 mAmp,100 Hz) is done during 30 sec at remifentanil level Ce of 4 ng/ml (with starting NOL value <10). According to the NOL response: increment of 1 ng/ml of RemiCe if NOL gradient ≥ 20 / decrement of 1 ng/ml of remifentanil Ce NOL gradient < 10. During the testing period propofol Ce is fixed at the concentration associated with BIS levels between 45-60 during the first calibration.
~Upon the incision and 2 minutes after skin incision, Propofol TCI (Schnider model) is adjusted to BIS between 45-60 and remifentanil Ce at which the variation of NOL index variation is less than10 units at a NOL starting value <10. MAP (mean arterial pressure), HR (heart rhythm) and NIBP (non-invasive blood pressure) will be measured.
~The formula derived from the calibration phase will be tested during a single tetanic stimulation at remifentanil Ce of 4 ng/ml during the validation phase."
15942312|NCT03324256|Other|energy drink|16 oz cold commercially-available energy drink
15942313|NCT03324256|Other|caffeinated drink|16oz cold commercially-available caffeinated drink
15942314|NCT03324256|Other|Energy gum|2 pieces of commercially-available energy gum
15942315|NCT03324256|Other|placebo gum|2 pieces of commercially-available placebo gum
15942316|NCT03324256|Other|Control drink|16oz cold control drink
15942317|NCT03324256|Other|Total sleep deprivation|24-hour total sleep deprivation prior to consumption of energy drink and placebo gum
15942318|NCT03324243|Drug|Crenolanib|66.7 mg/m2 three times a day (TID)
15942319|NCT03324243|Drug|Fludarabine|30 mg/m2/day, intravenous infusions over 30 mins.
15942320|NCT03324243|Drug|Cytarabine|2000 mg/m2/day, intravenous infusions over 1-3 hours.
15942321|NCT03324217|Other|Mental Practise|They made a mental task to produce a neurophysiological activation of the brain areas related to the planning and execution of voluntary movement in a manner that resembles how the action is performed in reality in combination with real exercises.
15942322|NCT03324204|Other|Neuromuscular Training|Each session lasted 30 minutes and consisted of three sets of exercises with 20-30 repetitions. Emphasis was placed on proper knee alignment during exercise. Most of the women exhibited excessive medial rotation and adduction of the femur, resulting in knee valgus, although knee varus was also observed. The women were instructed how to correct their abnormalities using mirrors as visual feedback. All exercises were completed without pain. If the exercises were too easy, the level of difficulty was increased individually in accordance with the rehabilitation protocol
15942323|NCT03324204|Other|Extracorporeal Shock Wave Therapy (ESWT)|ESWT will be applied to the iliotibial band and tensor fascia latae muscle with the following parameters: pressure - 4.5 bar, emission frequency -8 Hz, number of pulses per dose -2,500 per session
15942324|NCT03324191|Dietary Supplement|Placebo|Placebo will be matched for flavour, odour, and colour, to a tea beverage, without any active ingredient (tea extract).
15942325|NCT03324191|Dietary Supplement|Tea beverage|Tea beverage
15942326|NCT03324191|Dietary Supplement|Tea extract (medium concentration)|Tea extract (medium concentration) will be matched for flavour, odour, and colour, to a tea beverage, with a medium concentration of tea extract.
15942327|NCT03324191|Dietary Supplement|Tea extract (high concentration)|Tea extract (medium concentration) will be matched for flavour, odour, and colour, to a tea beverage, with a high concentration of tea extract.
15942328|NCT03324191|Dietary Supplement|High fat liquid meal challenge|"A dairy based standard study meal challenge providing 40 g dietary fat and less than 2 g carbohydrate or 1.2 g protein.
~For the tracer test subpopulation (n=15) the test meal will also contain 300 mg [1,1,1-13C3] tripalmitin to trace the incorporation of dietary lipid into plasma fatty acids."
15942329|NCT03324178|Behavioral|Neurofeedback training|Sixteen 30-minute sessions of neurofeedback training over four weeks: 7 x 3-minute blocks of training flanked by a 3-minute resting state block with eyes-open.
15942330|NCT03324178|Behavioral|Video game|Sixteen 30-minute sessions of video game playing over four weeks: 7 x 3-minute blocks flanked by a 3-minute seated relaxation.
15942331|NCT03324165|Other|Proposed Algorithm|Proposed algorithm that uses Alvarado Score to guide CT utilization
15942332|NCT03324152|Other|High-intensity interval training (HIIT) - myositis|12-weeks of 3 days/week HIIT. 6 sets of 30-60 seconds on 85-100% of maximal heart rate performed on a stationary bike followed by resistance training on 10 voluntary repetition maximum.
15942333|NCT03324152|Other|Standard low-intensity home exercise|12 weeks of 5 days/week low-intensity resistance home exercise in combination with outdoor walks of 20 minutes.
15942334|NCT03324152|Other|High-intensity interval training (HIIT) - healthy|12-weeks of 3 days/week HIIT. 6 sets of 30-60 seconds on 85-100% of maximal heart rate performed on a stationary bike followed by resistance training on 10 voluntary repetition maximum.
15942335|NCT03324139|Drug|Low molecular weight heparin|Patients included in this study group will receive 3,500 IU / 0.2 ml / day of Bemiparina sc, from inclusion to delivery (estimated median of 5-6 weeks, with a maximum of 13 weeks).
15942336|NCT03324139|Drug|Placebos|Patients included in this study group will placebo (same presentation as the active drug), from inclusion to delivery (estimated median of 5-6 weeks, with a maximum of 13 weeks).
15942337|NCT03324113|Drug|SAR408701|"Pharmaceutical form: solution for infusion
~Route of administration: intravenous"
15942338|NCT03324113|Drug|dexamethasone|"Pharmaceutical form: solution for eye drop
~Route of administration: eye drop"
15942339|NCT03324113|Drug|naphazoline|"Pharmaceutical form: solution for eye drop
~Route of administration: eye drop"
15942340|NCT03324113|Drug|diphenhydramine|"Pharmaceutical form: tablet
~Route of administration: oral"
15942341|NCT03324087|Diagnostic Test|HRQoL|use SF-36 and ITP-PAQ questionnaires to assess the HRQoL in patients with ITP in the real world, and analyze the influencing factors of HRQoL so as to provide a sufficient basis for clinical decision making.
15942342|NCT03324061|Drug|Fulvestrant for Injectable Suspension|Test drug is administered as a single 5mL intramuscular injection in the right or left dorsogluteal muscle area
15942343|NCT03324061|Drug|Faslodex (Reference)|Reference drug is administered as two 5mL intramuscular injections, one in each of the right and left dorsogluteal muscle areas
15942344|NCT03324048|Other|relaxation session|"During relaxation session, patients anxious will have three electrodes for save heart rate variability and a sensor for save value of the partial pressure of carbon dioxide.
~Before and after relaxation session, patient evaluates his anxiety by visual analogue scale (VAS) and State-Trait Anxiety Inventory (STAI-Y)."
15942345|NCT03324035|Drug|Amitriptyline|Administer amitriptyline on flexible doses variating from 25mg to 75mg, with backup of tramadol, and evaluate the reduction of the pain based on the Brief Pain Inventory Questionnaire.
15942346|NCT03324035|Drug|Placebo oral capsule|Administer amitriptyline on flexible doses variating from 1 to 3 capsules, with backup of tramadol, and evaluate the reduction of the pain based on the Brief Pain Inventory Questionnaire.
15942347|NCT03324035|Drug|Tramadol|"Administer to both arms on as needed scheme, to a maximum of 150mg/day."
15942348|NCT03324009|Diagnostic Test|2-stage screen|Pap smear is currently the standard of care for cervical cancer screening in Botswana. In this study, participants will undergo HPV DNA testing at the time of Pap smear collection. If HPV DNA test is positive, they will be referred for colposcopy. Patients who have an HPV negative test but positive Pap smear will be referred for colposcopy per Botswana cervical cancer screening guidelines.
15942349|NCT03323996|Other|Semi-Structured interviews|individual semi-structured interviews
15942350|NCT03323983|Other|data collection|data collection
15942351|NCT03323970|Other|semi-structured interviews|individual semi-structured interviews
15942352|NCT03323957|Diagnostic Test|nutritional screening tool|screening of disease associated malnutrition in sick infants
15942353|NCT03323944|Biological|huCART-meso cells|Intravenous administration or local delivery of lentiviral transduced huCART-meso cells.
15942354|NCT03323931|Behavioral|(2) robot--enhanced intervention|The tasks included in the treatment follow a structured behavioral approach, called the discrete trial training (DTT). The learning process is guided by the robotic agent (Softbank Robotics Nao robot). All activities follow a gameplay scenario and they take place at a table, which in the case of joint attention and turn taking tasks incorporates a large touchscreen. Each behavior presented to the child is preceded by instructions and followed by a contingent reinforcement. The contingent reinforcement and prompting are used to train each targeted behavior/action. The behaviors are presented over multiple and successive trials and explicit prompting is giving when the child doesn't succeed to accomplish the targeted behavior. Each action is repeated three times. For every child, the intervention for each ability starts from the level determined in the first two sessions, but as the child's performance improves, the task moves to a more complex level.
15942389|NCT03323658|Other|Questionnaire Administration|Ancillary studies
15942415|NCT03323450|Behavioral|CogMed®|"It consists of 25 training sessions which can all be completed online and at home. Each session lasts 30-45 minutes. They must have a computer at home compatible with the CogMed® program.
~Brief neuropsychological evaluations will be conducted at 4 time points (these assessments are standard of care):
~Baseline before the participant is introduced to the CogMed® training program
~Within 2 weeks of completion of the CogMed® program
~At 3 months of completion of the CogMed® program to establish maintenance of gains
~At 6 months of completion of the CogMed® program to establish longer-term maintenance of gains"
15942616|NCT03321799|Device|Sterile Antimicrobial Dressings|Control group, current hospital standard.
15942355|NCT03323931|Behavioral|(1) discrete trial training / cognitive-behavior therapy|The tasks included in the treatment follow a structured behavioral approach, called the discrete trial training (DTT). The learning process is guided by an interaction partner (human), under the supervision of the therapist. All activities follow a gameplay scenario and they take place at a table, which in the case of joint attention and turn taking tasks incorporates a large touchscreen. Each behavior presented to the child is preceded by instructions and followed by a contingent reinforcement. The contingent reinforcement and prompting are used to train each targeted behavior/action. The behaviors are presented over multiple and successive trials and explicit prompting is giving when the child doesn't succeed to accomplish the targeted behavior. Each action is repeated three times. For every child, the intervention for each ability starts from the level determined in the first two sessions, but as the child's performance improves, the task moves to a more complex level.
15942356|NCT03323918|Other|ImPACT|Teaching parents to train social communicative skills as outlined in arm description.
15942357|NCT03323918|Other|TAU|TAU can include targeting eating and sleeping problems, adaptive skills, or other goals.
15942358|NCT03323905|Device|Symphony MRI guided High Intensity Focused Ultrasound (HIFU)|The use of the MRI-HIFU for the ablation of leiomyomas
15942359|NCT03323892|Other|second masturbation|Husbands will be asked to produce a second sperm sample in the masturbatorium
15942360|NCT03323879|Radiation|LDR/HDR|Focal LDR to dominant lesion with whole gland 19 Gy HDR
15942361|NCT03323866|Drug|Budesonide 0.5 MG/ML|2 cc nebule of budesonide in 240 cc of saline water (Sinus Rinse) once daily
15942362|NCT03323866|Drug|Mometasone nasal spray|Mometasone 50 mcg/spray 2 sprays twice daily
15942363|NCT03323853|Behavioral|Computerized Assessment and Referral System (CARS) Self-Assessment Screener|Subjects will take the CARS-SA Screener.
15942364|NCT03323853|Behavioral|CARS-SA Summary Results|Subjects will be evaluated by emergency care providers using the CARS-SA Summary Results Report.
15942365|NCT03323840|Other|Incentivized Care|Patients will receive a $10 gift card for every blood pressure measurement (up to 2 times/month)
15942366|NCT03323814|Device|Slow-wave optimization|employing sensory stimulation to enhance slow waves
15942368|NCT03323775|Diagnostic Test|Suprathreshold stimulation|Intraoperatively, radiofrequency needles will be placed on specific nerves targeted using parallel needle placement technique under image guidance. These nerves will have identified by the diagnostic injections carried out previously. The nerves will be located using 50 Hz sensory stimulation. The targeted medial branches (dorsal ramus in the case of L5) will be stimulated using suprathreshold stimulation (up to three times the sensory detection threshold) to identify the pain referral area. Motor stimulation of 2 Hz will be used to identify the multifidus muscle as well as to evaluate the close proximity to major spinal nerve to improve the safety of the procedure.
15942369|NCT03323762|Device|Remote Ischaemic Conditioning (RIC)|The CellAegis auto RIC (automated blood pressure cuff) will be placed on the upper arm and inflated to 200 mmHg for 5 minutes followed by 5 minutes of deflation. The programmed cycle is repeated 4 times in total, summing up to a total treatment length of 35 minutes
15942370|NCT03323749|Combination Product|elamipretide|40 mg of elamipretide administered as once daily 0.5 mL subcutaneous injections for 24 weeks using the elamipretide delivery system
15942371|NCT03323749|Combination Product|placebo comparator|40 mg of placebo administered as once daily 0.5 mL subcutaneous injections for 24 weeks using the elamipretide delivery system
15942372|NCT03323749|Combination Product|elamipretide open label treatment|40 mg of elamipretide administered as once daily 0.5 mL subcutaneous injections for up to 144 weeks using the elamipretide delivery system
15942373|NCT03323736|Combination Product|Iontophoresis & tube placement|Subjects will receive active Tymbion iontophoresis and will have tubes placed in-office using the Tube Delivery System in all ears indicated for tube placement.
15942374|NCT03323736|Device|Tube placement|Subjects will have tubes placed in the OR using the Tube Delivery System in all ears indicated for tube placement.
15942375|NCT03323723|Device|SUI Device|Pessary SUI device
15942376|NCT03323710|Drug|Propranolol|Propranolol will be administered orally at a starting dose of 40 mg (one tablet) two times a day (total daily dose of 80 mg). In case of acceptable safety profile, the dose may be increased to 80 mg (two tablets) two times a day (total daily dose of 160 mg) or farther to 80 mg (two tablets) three times a day (total daily dose of 240 mg).
15942377|NCT03323710|Drug|Sunitinib|Sunitinib will be administered orally at a starting dose of 50 mg once daily, for 4 consecutive weeks, followed by a 2-week rest period (schedule 4/2) to comprise a complete cycle of 6 weeks.The schedule may be changed to 2 weeks on / 1 week off (schedule 2/1) and a daily dose may be reduced to 37.5 mg or 25 mg to decrease the level of toxic side effects.
15942378|NCT03323697|Other|SZ-05|2.5g a day (3 capsules twice a day)
15942379|NCT03323697|Drug|Escitalopram Pill|10 mg capsule plus 5 placebo capsules
15942380|NCT03323684|Other|Quadratus lumborum block Group (QL)|20 mL of 0.375% isobaric bupivacaine for each side deposited at the posterior aspect of the quadratus lumborum muscle (QLB type 2) using ultrasound after induction of general anesthesia and 15 minutes before start of surgery
15942381|NCT03323684|Other|Transversus abdominis plane Group (TAP)|20 mL of 0.375% isobaric bupivacaine for each side using ultrasound after induction of general anesthesia and 15 minutes before start of surgery
15942382|NCT03323684|Other|Control group (C)|No intervention will be done
15942383|NCT03323684|Drug|Paracetamol infusion|Paracetamol infusion (15 mg.kg) will be given by intravenous infusion after induction of general anesthesia.
15942384|NCT03323684|Drug|Ketorolac analgesia|In PACU Ketorolac 30 mg ampoule will be given by intravenous infusion to all cases and then every 8 hours.
15942385|NCT03323684|Drug|fentanyl|With induction of general anaesthesia, fentanyl (1 microgram.kg) will be given. Intraoperatively, Fentanyl boluses (0.5 microgram.kg) will be given in case of increase in intraoperative mean arterial blood pressure or heart rate of more than 20% of baseline for longer than 5 minutes. Postoperatively, Fentanyl boluses (20 micrograms) will be given if VAS is more than 3 and it might be repeated after 30 minutes until VAS is ≤ 3.
15942386|NCT03323671|Drug|preemptive mefenamic acid|preemptive analgesia before menstrual pain
15942387|NCT03323671|Drug|mefenamic acid|mefenamic acid given only during menstruation
15942388|NCT03323658|Drug|Bexarotene|Given topically
15942390|NCT03323632|Device|MyndMove|During a MyndMove therapy session, the patient is instructed to attempt to execute a task voluntarily. As the patient is attempting to perform the designated task, specific muscles in the arm are stimulated to generate contractions that produce the desired movement. After a brief interval of the patient attempting to initiate a movement the therapist activates the MyndMove stimulation protocol, which generates bursts of short electrical pulses, using surface electrodes, to produce muscle contractions enabling the patient to complete the desired/instructed task. Proper sequencing of the muscle contractions as per the MyndMove protocols are tailored to achieve a wide range of reaching and grasping functions. The technique stimulates non-damaged pathways of the central nervous system.
15942391|NCT03323619|Procedure|anesthesia type|No intervention. General anesthesia or local anesthesia with sedation are decided by the physicien according to his usual practice
15942392|NCT03323606|Behavioral|Gambling Internet Intervention|The gambling Internet intervention consists of a new online version of self-change tools that have previously been translated successfully into an online form and shown to have a significant impact on gambling in three trials. A major focus of this intervention is to provide individuals with clear and concise behavioral and cognitive strategies for meeting the goal of reducing or quitting gambling.
15942393|NCT03323606|Behavioral|Check Your Drinking|A brief online intervention designed to provide personalized normative feedback aimed at motivating reductions in drinking
15942394|NCT03323593|Drug|Dexmedetomidine|blood is sampled for quantification of plasma concentration after intravenous, intranasal by atomisation and intranasal by drops.
15942395|NCT03323580|Other|SVV-based GDFT|Target SVV will be titrated with fluid bolus, and thus individual amount varied depending on the SVV value at that time. Maintenance of oxygenation, hemoglobin, blood glucose, core temperature and hemodynamics, such as minimal cardiac indices, mean arterial pressure and heart rate, will be applied according to the same standard for each patient.
15942396|NCT03323580|Other|traditional fluid therapy|Fluid therapy will be done without goal-directed SVV . Maintenance of oxygenation, hemoglobin, blood glucose, core temperature and hemodynamics, such as minimal cardiac indices, mean arterial pressure and heart rate, will be applied according to the same standard for each patient.
15942397|NCT03323567|Drug|MD Muscle GUNA collagen|intramusclular injections of MD Muscle collagen
15942398|NCT03323567|Drug|Lidocaine 2% Injectable Solution|intramuscular Lidocaine 2% injection
15942399|NCT03323567|Drug|Saline Solution, Hypertonic|intramuscular Saline injection
15942400|NCT03323554|Device|Ustrap®|Patients will receive Ustrap® under general or loco-regional anaesthesia, by perineal approach.
15942401|NCT03323554|Device|AMS 800®|Patients will receive AMS 800® under general or loco-regional anaesthesia. Small openings are made near the scrotum and below the abdomen to insert an inflatable cuff, a pump and a small balloon (pressure regulating balloon).
15942402|NCT03323541|Drug|Filgrastim Prefilled Syringe [Zarzio®]|Daily subcutaneous injection of Zarxio post ASCT, from day 5 until bone marrow recovery (neutrophils >1 giga/l)
15942403|NCT03323528|Drug|Benzalkonium Chloride-Benzocaine Topical|Dorithricin = tyrothricin, benzalkonium chloride, benzocaine
15942404|NCT03323528|Drug|Placebo Oral Tablet|"Placebo Oral Tablet = a lozenge with matched appearance and the same excipients as Active Comparator Dorithricin lozenge.
~Intervention: Patients are instructed to administer at home 1 lozenge at intervals of 2 hours (±15 minutes) up to a maximum of 8 lozenges per day."
15942405|NCT03323502|Behavioral|ACP Specialist Program|New structured role with responsibility for ACP
15942406|NCT03323489|Radiation|Celiac Plexus Radiosurgery|patients will receive a single radiation treatment of 25 Gy directed towards the celiac surgery, and at the physician's discretion also abutting tumor
15942407|NCT03323476|Other|Discontinuation (or not initiation) of Immunosuppressive Therapy|Discontinuation (or not initiation) of Immunosuppressive Therapy
15942408|NCT03323476|Drug|Maintenance (or initiation) of immunosuppressive treatment: Imurel®, Mabthera®,Cellcept®, Cortancyl®|Maintenance (or initiation) of Immunosuppressive Therapy: Imurel®, Mabthera®,Cellcept®, Cortancyl®
15942416|NCT03323437|Drug|Risperidone|Participants will meet with a study doctor physician once per week (about 3 times total) to monitor progress and side-effects of risperidone, which includes taking 4 assessments each time. After 4 weeks of taking Risperidone, participant will be assessed and scanned with the MRI/MRS scanner again.
15942417|NCT03323424|Radiation|Systemic treatment + Stereotactic Body Radio-Therapy (SBRT)|"According to the usual practice, patients will receive their systemic treatment, composed of :
~Taxane + trastuzumab +pertuzumab for metastatic breast cancers;
~FOLFOX or FOLFIRI + cetuximab for metastatic colorectal cancers;
~5FU-Platine + cetuximab for metastatic head and neck cancers; for six cycles and a maintenance of the targeted therapy until progression or unacceptable toxicity.
~If progression occurs before the 6th cycles, patients could receive a different line of treatment, according to the usual practice.
~In addition to the systemic treatment, patients randomized into this experimental group will receive a SBRT of 45Gy in 3 fractions for hepatic and pulmonary metastasis, 27Gy in 3 fractions for bone metastasis and 33 Gy in 3 fractions for intra-cranial metastasis."
15942418|NCT03323424|Other|Systemic treatment|"According to the usual practice, patients will receive their systemic treatment, composed of :
~Taxane + trastuzumab +pertuzumab for metastatic breast cancers;
~FOLFOX or FOLFIRI + cetuximab for metastatic colorectal cancers;
~5FU-Platine + cetuximab for metastatic head and neck cancers; for six cycles and a maintenance of the targeted therapy until progression or unacceptable toxicity.
~If progression occurs before the 6th cycles, patients could receive a different line of treatment, according to the usual practice."
15942419|NCT03323411|Behavioral|Advance Care Treatment Plan|subjects in experimental group are taught information on dementia mechanical ventilation tube feeding and cardiopulmonary resuscitation
15942420|NCT03323398|Biological|mRNA-2416|mRNA encoding human OX40L
15942421|NCT03323398|Biological|Durvalumab|PD-L1 inhibitor
15942422|NCT03323385|Drug|N1539|Once Daily
15942423|NCT03323385|Drug|Placebo|Once Daily
15942424|NCT03323372|Drug|3% potassium nitrate and 0.25% sodium fluoride|
15942425|NCT03323372|Drug|5% potassium nitrate and 2% sodium fluoride|
15942426|NCT03323359|Device|Hemopatch|Hemopatch is applied upon the verification made by the surgeon of the presence of an appropriate target bleeding site in the hepatic parenchyma. At the time point of application a stopwatch starts simultaneously. Time to hemostasis is defined as the time required to obtain successful haemostasis in a single bleeding site. At 3 minutes the inspection will be made and, if haemostasis is not achieved, the treatment is considered failed and the Principal Investigator and/or his delegates is allowed to use additional haemostatic measures.The time to haemostasis will be recorded in the patient's medical record and in the electronic Case Report Form. The bleeding site will be observed for 1 additional minute at the end of the haemostatic procedure and, of the surgery to confirm the haemostasis.
15942427|NCT03323359|Procedure|Common Surgical Techniques|Patients undergoing liver resection for any underlying disease and with resectable mass. The list of the underlying diseases is the following (but might not be limited to): Hepatocellular carcinoma, Hilar cholangiocarcinoma, Adrenal cancer metastasis, Breast cancer metastasis, Colorectal cancer metastasis, Ovarian cancer metastasis, Biliary carcinoma, Hemangioma, Hepatic adenoma, Focal nodular hyperplasia, Unilocular hydatid cyst, Multilocular, hydatid cyst.
15942428|NCT03323346|Drug|Disulfiram|"Patients will take one pill of disulfiram (Antabus) daily at a dose of 400 mg continually during the treatment phase (from day 0 till End of treatment Visit). In case of intolerance, lower dose up to 200 mg per day is allowed.
~Copper supplementation will be given separately from disulfiram; in the morning with patients´breakfast. Patients will take one pill of copper dietary supplement (for instance Copper Star, STARLIFE) corresponding to 2 mg of elementary copper."
15942429|NCT03323333|Behavioral|psychosocial counseling|A problem-solving and psychosocial skill-building intervention.
15942430|NCT03323307|Device|OCT imaging|imaging of retina using OCT device
15942431|NCT03323281|Other|Neuropsychological assessments|Maintenance of approximately 1h30 with a neuropsychologist or a physician trained in neuropsychological assessments in Diabetic Type 1 or Type 2 with foot wound hospitalization and Diabetic Type 1 or Type 2 without a foot wound or antecedent Of foot wound (podological risk grade 0 to 2, including foot of Charcot)
15942432|NCT03323268|Device|PetCO2 monitoring|CO2 analyzer on ventilator expiratory lane. On-line, continuous, and noninvasive monitor. Routine use in anesthesia and intensive care units.
15942433|NCT03323255|Device|repeated transcranial magnetic stimulation continuous theta-burst stimulation|cTBS
15942434|NCT03323255|Device|SHAM repeated transcranial magnetic stimulation|SHAM stimulation
15942435|NCT03323242|Device|LigaSure|The dissection of the small blood vessels and the connective tissue in the hepatoduodenal ligament is carried out with LigaSure
15942436|NCT03323242|Device|Harmonic Ultrasonic dissector|The dissection of the small blood vessels and the connective tissue in the hepatoduodenal ligament is carried out with Harmonic Ultrasonic dissector
15942437|NCT03323229|Diagnostic Test|Enhanced communications & ultrasound|Paramedics will perform standardised point-of-care ultrasound scan protocols (specific to the patient's symptom set) and record a short (<1 minute) video summarising the patient's condition and current management. These will be transmitted via satellite to consultants at the receiving hospital before the ambulance leaves the incident scene. The emergency department consultants will provide support and advice on continuing patient management via standard ambulance communications systems while it is en route to the hospital.
15942438|NCT03323216|Diagnostic Test|6-minute walk test|"The 6-minute walk test is a functional test established in the clinic to assess the performance of a patient. The patient walks continuously for 6 minutes without interruption as far as possible. Breaks, speed changes and running are allowed.
~Test is performed prior the CRT implantation and 6 months after the CRT implantation."
15942439|NCT03323216|Diagnostic Test|Study specific questionnaire|"Study specific questionnaire
~The questionnaire is performed prior the CRT implantation and 6 months after the CRT implantation."
15942440|NCT03323216|Procedure|Blood collection|"Blood collection during surgery:
~coronary sinus
~arterial
~peripheral venous
~Blood collection 6 months after surgery:
~- peripheral venous"
15942441|NCT03323203|Device|FORE-SIGHT Elite, CASMED, Inc., Branford, Connecticut, USA|Tissue oxygenation was monitored using a tissue oximeter based on near-infrared spectroscopy (FORE-SIGHT Elite, CASMED, Inc., Branford, Connecticut, USA). The oximeter had four cables with each cable connected to an adhesive probe.
15942442|NCT03323190|Behavioral|Inpatient COPD education|
15942443|NCT03323177|Dietary Supplement|Gender specific nutritional standardized formula|Patients will continue to consume the study formula until final height: gender specific powder added to water containing about 25% of recommended DRI for calories, high protein (25% of calories) and multi vitamin and mineral (255-100%) of DRI for recommended daily allowance (RDA) or adequate intake
15942444|NCT03323177|Other|Follow-up only|Patients who are reluctant to continue to consume the study formula will come to follow-up visits only without any intervention until final height is reached
15942445|NCT03323164|Drug|Timolol Maleate|Instillation of one drop in each eye, one-time. Obtaining of OCT angiography scans after 2 hours of instillation.
15942446|NCT03323164|Drug|Brimonidine Tartrate|Instillation of one drop in each eye, one-time. Obtaining of OCT angiography scans after 2 hours of instillation.
15942447|NCT03323151|Drug|Ixazomib|Ixazomib 3 mg by mouth on days 1, 8 and 15 by mouth days 1-28 of a 28 day cycle. Dose may be de-escalated (Ixazomib 3 mg) or escalated (Ixazomib 4 mg) dependent on dose-limiting toxicities.
15942448|NCT03323151|Drug|Ixazomib|Ixazomib 4 mg by mouth on days 1, 8 and 15 of a 28 day cycle until progression or unacceptable toxicity.
15942449|NCT03323151|Drug|Ibrutinib|Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle. Dose may be de-escalated (Ibrutinib 420 mg) or escalated (Ibrutinib 560 mg) dependent on dose-limiting toxicities.
15942450|NCT03323151|Drug|Ibrutinib|Ibrutinib 560 mg by mouth days 1-28 of a 28 day cycle until progression or unacceptable toxicity.
15942451|NCT03323138|Procedure|Ex-PRESS and phacoemulsification|
15942452|NCT03323125|Other|Self-Assessment Questionnaire|Self-assessment questionnaire with sun exposition, sun protection, vitiligo severity and vitiligo outbreaks, will be suggested to patient during medical consultation.
15942453|NCT03323112|Biological|influenza vaccine|Vaccine for prevention of influenza. Vaccines change by influenza season.
15942454|NCT03323099|Behavioral|N-of-1|Participants in the N-of-1 arm will use the Eureka mobile application and AliveCor device to tracking their AF episode frequency and severity and execute at least one N-of-1 trial with the goal of identifying and better controlling their AF triggers.
15942455|NCT03323099|Behavioral|Data Tracking|Participants in the data tracking arm will use the Eureka app and AliveCor device to record daily AF frequency and severity and daily AliveCor readings for a period of 10 weeks.
15942456|NCT03323086|Behavioral|Brief Intervention (BI) with Technology Extender|One, 45-60 minute BI, followed by three months of access to technology extenders
15942457|NCT03323086|Other|Brochure|Brochures provided one time
15942458|NCT03323073|Other|Resting state fMRI|One single fMRI which is used to characterize a uni or a bipolar major depressive episode (MDE).
15942459|NCT03323060|Device|Transanal endoscopic surgical procedure|Resection of tumors or lesions
15942460|NCT03323047|Drug|Acetaminophen|Oral acetaminophen (15 mg/kg) 1 hr pre-operatively
15942461|NCT03323047|Drug|Low-dose Dexamethasone|Intravenous low-dose dexamethasone (0.15 mg/kg, max. 8 mg) immediately after induction of anesthesia
15942462|NCT03323047|Drug|Placebo Oral Tablet|Oral placebo 1 hr pre-operatively
15942463|NCT03323047|Drug|High-Dose Dexamethasone|Intravenous high-dose dexamethasone (0.5 mg/kg, max. 10 mg) immediately after induction of anesthesia
15942464|NCT03323034|Drug|Irinotecan|Given IV
15942465|NCT03323034|Drug|Pevonedistat|Given IV
15942466|NCT03323034|Drug|Temozolomide|Given PO
15942467|NCT03323021|Other|Dehydrated human amnion/chorion membrane|dehydrated human amnion/chorion membrane
15942468|NCT03323021|Other|Standard of Care|Standard of Care
15942469|NCT03323008|Other|Prototype|Usability testing and System Usability Scale
15942470|NCT03322995|Drug|First-line Chemotherapy|The first-line therapy will be 5-fluorouracil, leucovorin, irinotecan, and oxaliplatin (FOLFIRINOX) or best available standard of care.
15942471|NCT03322995|Drug|Second-line Chemotherapy|Second line therapies will be multi-agent and contain gemcitabine. Molecular profiling data from the initial endoscopic ultrasound (EUS)/ fine needle aspirate (FNA) biopsy may be used at the discretion of the treating physician.
15942472|NCT03322995|Radiation|Chemoradiation|50.4 Gy in 28 fractions.
15942473|NCT03322982|Behavioral|Low-fat diet|less than 20% calories from fat daily
15942474|NCT03322969|Drug|Paclitaxel/DDP|receiving the modified chemotherapy
15942475|NCT03322969|Drug|XELOX/SOX|receiving the original chemotherapy
15942476|NCT03322956|Other|Physioterapy intervention|"In the experimental group (EGR), the 4MTOR® treatment method will be used for LBP. This 4MTOR® uses the following steps in a decision tree: T1 Testing (Physiotherapeutic examination), T2 Triggering (Manual Techniques), T3 Taping (Elastic Tape) and T4 Training (medical rehabilitation exercises).
~The participants in the SGR received a sham multimodal physiotherapeutic intervention as control intervention, in which Sham technique were applied. The interventions consisted of combining Sham manual interventions, elastic tapes according to Kaze32 and Evidence Based Practice Therapy (Appendix III). The protocol in the SGR follows the similar steps: Testing, Taping, Triggering and Training like the 4MTOR®."
15942477|NCT03322930|Diagnostic Test|Rod sensitivity|diagnostic test for rod loss in central retina
15942478|NCT03322917|Biological|PRP autologous|Autologous platelet rich plasma: 1 drop / 6 times a day during 6 weeks
15942479|NCT03322904|Diagnostic Test|iris photography|"The LF (0.04-0.15 Hz) and HF (0.16-0.4 Hz) ratings were recorded for 24 hours (day and night average) by Holter recording system
~Photographs of both irises of the healthy volunteers were taken . An image software program was used to draw circular limits over the iris exterior circle (IEC), coloretta circle (CC), and pupil circle (PC) on digital photographs. The areas between the circles were measured. The likelihood that the IRIS ratio was equal to the LF/HF ratio was calculated using the formula [IEC-PC¬] - [CC-PC] / [CC-PC]."
15942480|NCT03322891|Other|Educational Supplement|Participants will receive education about prostate cancer and treatments using models and props during a face-to-face interview. During the interview, participants will also be asked about medical terms and treatments regarding prostate cancer. The interview will last 45 to 60 minutes.
15942481|NCT03322891|Other|Standard Practice Education|Participants will receive traditional standard of care education regarding prostate cancer treatments and side effects provided by their physician.
15942482|NCT03322878|Drug|Magnesium SO4|The intravenous solutions (magnesium 10% for group IV or saline 0.9% for group CA and P) will be started then caudal block will be performed by the same anesthetist. Under complete aseptic conditions a caudal puncture with 5 cm short beveled 22 G caudal needle will be used in the lateral decubitus position. After identifying the space using the loss of resistance technique with saline, the study solutions will be injected slowly with repetitive intermittent aspiration.
15942509|NCT03322670|Other|Patients with partial participation|- collection of clinical examination data
15942483|NCT03322865|Drug|Obinutuzumab|"Induction:
~Cycle 1 (28 days cycle): Obinutuzumab (OBINUTUZUMAB) 1000mg i.v. fixed dose day 1,8,15*
~*In the case of suspected increased risk of severe IRR, the dose of obinutuzumab may be 100 mg intravenously on day 1 in cycle 1, 900 mg on day 2.
~Cycle 2-6 (28 days cycle): Obinutuzumab (OBINUTUZUMAB) 1000mg i.v. fixed dose day 1 Maintenance
~Start 8 weeks after the last induction cycle for patients at least achieving a partial response after induction:
~Obinutuzumab (OBINUTUZUMAB) 1000mg i.v. fixed dose day 1 every 8 weeks for a maximum of 12 infusions unless progression or study drug - related intolerable toxicity"
15942484|NCT03322852|Other|Vascularization indices observation|The mid-luteal endometrial thickness and volume, uterine vascularization indices of uterine artery pulsatility index and resistance index, endometrial and subendometrial vascularization index, flow index, and vascularization flow index, and serum estradiol and progesterone levels were calculated in spontaneous then stimulated cycles in the same group of infertile patients
15942485|NCT03322839|Behavioral|Multifaceted implementation strategies|The school-management will participate in a one-day training aimed at providing knowledge and skills related the recommendations of the guideline for the prevention of common mental disorders at the workplace.In addition every intervention school will form an implementation team that is responsible for the implementation of the guideline. The implementation team will comprise of approximately 3-5 individuals with experience in the field of social and organizational work environment, for example school-management and occupational health and safety representative. The implementation teams will participate in 4-5 workshops aimed at supporting the implementation process. Intervention schools within the same municipality will participate in the same workshop in order to promote peer-support.
15942486|NCT03322839|Behavioral|Single implementation strategy|The school-management will participate in a one-day training aimed at providing knowledge and skills related to the recommendations of the guideline for the prevention of common mental disorders at the workplace
15942487|NCT03322826|Procedure|systematic sampling of the lymph-node|Systematic Sampling of lymph nodes
15942488|NCT03322826|Procedure|lymphadenectomy|Routine lymph nodes dissection in lung cancer
15942489|NCT03322813|Device|ExAblate 4000 - Type 2|Using ExAblate Model 4000 Type-2 to temporarily disrupt the blood brain barrier in non-enhancing suspected infiltrating glioma undergoing resection
15942490|NCT03322800|Drug|AK0529|Active Substance: AK0529, Pharmaceutical Form: Capsule, Route of Administration: Oral
15942491|NCT03322800|Other|Placebo|Active Substance: Placebo, Pharmaceutical Form: Capsule, Route of Administration: Oral
15942492|NCT03322787|Device|HFO|Training will be done using the HFO device. Air-flow will set at the highest value tolerated by the patients, until a maximum value of 60 l/min permitted and FiO2 set during the run-in. The HFO will be administered using the AIRVO2® (Fisher&Paykel- NewZealand). Afterwards, the oxygen flow provided into the system will be progressively increased until the pre-fixed FiO2 will be reached, as displayed by the AIRVO2 monitor.
15942493|NCT03322774|Behavioral|digital Cognitive Behavioral Therapy for Insomnia|"Cognitive Behavioral Therapy for Insomnia administered online through the Sleepio program. Treatment utilizes sleep restriction, stimulus control, and cognitive therapy. Treatment is administered through 6 weekly, hour-long online video sessions with an animated figure called The Prof, which delivers the treatment."
15942494|NCT03322774|Behavioral|face-to-face Cognitive Behavioral Therapy for Insomnia|Cognitive Behavioral Therapy for Insomnia administered by experienced staff trained in behavioral sleep medicine. Treatment utilizes sleep restriction, stimulus control, and cognitive therapy. Treatment is administered through 6 weekly, hour-long face-to-face sessions with an experienced staff member trained in behavioral sleep medicine.
15942495|NCT03322774|Behavioral|Sleep Hygiene Education Control|Participants are provided with information about good sleep hygiene through 6 weekly emails. Participants practice good sleep hygiene as part of their sleep routine. In Step 1, sleep hygiene control will be exclusively online. In Step 2, sleep hygiene control includes an in-person, face-to-face component.
15942496|NCT03322761|Combination Product|Systematic exercise training|Combination of standard medical treatment and systematic early exercise training in persons with MS.
15942497|NCT03322761|Behavioral|Educational program|Informations regarding health benefits of physical activity and exercise.
15942498|NCT03322748|Other|Usual physical therapy+ strengthening of lower limbs muscles|Experimental group will perform usual physical therapy plus 3 series of isometric contractions of ankle plantarflexor and Hamstring muscles bilaterally, each lasting 5 seconds.
15942499|NCT03322748|Other|Usual physical therapy|Usual physical therapy
15942500|NCT03322735|Drug|Fludarabine|25-30mg/m2/day IV for 3 days
15942501|NCT03322735|Drug|Cyclophosphamide|cyclophosphamide 0.6-0.8g/m2/day IV for 2 days
15942502|NCT03322735|Biological|BCMA CAR-T|BCMA CAR-T cells will be administered after completion of the chemotherapy.
15942503|NCT03322709|Procedure|kidney transplant|Transplantation of a kidney either by open surgery or robotic assisted laparoscopic surgery.
15942504|NCT03322683|Procedure|Physiotherapy treatment with physium device.|This group will treated five times with the analgesic program of physium therapy. Each maneuver was performed once per session by slow and progressive. The whole procedure lasted no more than 45 minutes.
15942505|NCT03322683|Procedure|Conventional physiotherapy treatmen|The PT group will treated during two weeks (ten days/week) with ultrasound therapy (US), transcutaneous electric nerve stimulation (TENS) and massage, in this order. Ultrasound will applied in pulse mode at an intensity of 1 megahertz for 10 minutes in the sub-occipital region and the vicinity of the trapezius muscles. TENS will applied with a pulse duration of 250 microseconds at a frequency of 80 Hertz for 20 minutes in the sub-occipital region and the trapezoids. Deep massage was applied at a slow speed for 20 minutes using sliding neutral creams. Massage therapy included gliding and kneading techniques applied over trapezius (upper, lower and middle fibers), splenius capitis and levator scapulae muscles with a therapeutic intention.
15942506|NCT03322670|Other|Signs of CAP and a positive chest X-Ray|"collection of clinical examination data
~biological and bacteriological examinations (blood, urine, sputum, nasopharyngeal)
~self-reported questionnaires on duration of symptoms and restriction of activity
~telephone contact on day 28 and day 90 if hospitalized before day 28"
15942507|NCT03322670|Other|Patients directly hospitalized|"collection of clinical examination data
~telephone contact on day 28 and retrieval of hospitalization report
~telephone contact on day 90"
15942508|NCT03322670|Diagnostic Test|Control patients|- bacteriological examinations (urine)
15942514|NCT03322644|Behavioral|Internet-based CBT intervention|The Internet-delivered Pancreatitis Pain Course consists of 5 lessons: 1) introduction, education, and symptom identification, 2) thought monitoring and challenging, 3) controlled breathing and pleasant activity scheduling, 4) activity pacing, and 5) relapse prevention and goal setting. Participants aim to complete one online lesson weekly for 5 weeks, and have up to 2 months to complete the course. Each lesson has a homework assignment to encourage participants to practice and apply skills. A coach who is part of the Seattle Children's Research Institute study team will make weekly contact with participants in the intervention arm through telephone or secure e-mail, for a period of between 10-15 minutes to encourage participants to work through the Course and apply the skills.
15942515|NCT03322631|Drug|Tirzepatide|Administered SC.
15942516|NCT03322631|Drug|Placebo|Administered SC.
15942517|NCT03322618|Biological|blood samples|7 tubes of 6 ml (42 ml of blood )
15942518|NCT03322592|Diagnostic Test|Rapid on-site evaluation (ROSE)|On-site evaluation of the acquired samples will be performed by pathologist
15942519|NCT03322592|Diagnostic Test|Histologic evaluation|Samples collected in the EUS-FNB without ROSE will be processed as histologic samples
15942520|NCT03322579|Device|Balloon dilatation Eustachian tuboplasty|Eustachian tuboplasty by balloon dilation involves the recanalization of the cartilaginous portion of the ET via the nasopharynx with a balloon catheter. This catheter is inflated to multiple atmospheres of pressure for a short amount of time and then removed.
15942521|NCT03322566|Drug|Pembrolizumab|Pembrolizumab administered intravenously every 3 weeks.
15942522|NCT03322566|Drug|Epacadostat|Epacadostat administered orally twice daily.
15942523|NCT03322566|Drug|Platinum-based chemotherapy|Investigator selected one of the following regimens: pemetrexed + cisplatin, pemetrexed + carboplatin, or paclitaxel + carboplatin, depending on histology.
15942524|NCT03322566|Drug|Placebo|Matching placebo administered orally twice daily.
15942525|NCT03322553|Device|GERD-X|Endoscopic full-thickness plication will be performed using the GERDX® system. All procedures will be performed under general anesthesia. Savary-guidewire will be placed into the stomach using a gastroscope. The GERDX® system will be introduced over the guidewire into the stomach and retroflexed. The GE junction will be visualized using another slim endoscope passed through a channel present in the GERD-X device. According to study protocol, at least 2 pretied transmural pledgeted sutures will be deployed to achieve a tight closure of gastro-esophageal junction around the GERD-X device.
15942526|NCT03322540|Drug|Pembrolizumab|Pembrolizumab administered intravenously every 3 weeks.
15942527|NCT03322540|Drug|Epacadostat|Epacadostat administered orally twice daily.
15942528|NCT03322540|Drug|Placebo|Matching placebo administered orally twice daily.
15942529|NCT03322514|Dietary Supplement|Inulin-Propionate Esters|Inulin (β(2-1) linked polymer of fructose) carrier with an ester linked to propionate (propionate ester). Thus, propionate is only released when the carrier molecule inulin is fermented by colon microflora.
15942530|NCT03322514|Dietary Supplement|Inulin|Inulin
15942531|NCT03322501|Behavioral|Provider Advice, Framed Messaging|The purpose of the study is to determine if an Ask, Advise, Connect (AAC) intervention model benefits tobacco control outcomes for pediatric primary care providers (pPCP's) and their young patients.
15942532|NCT03322488|Procedure|Fistulodesis|"Fistulodesis comprises the following treatment steps:
~Curettage and/or brushing of the fistula tract
~Mini-excision of the inner (endoanal) fistula opening
~Flushing of fistula tract with acetylcysteine (Concentration: 100mg/ml, max. dosage: 20ml)
~Flushing/ filling of fistula tract with doxycycline (Concentration: 20mg/ml, max. dosage: 10ml)
~Filling the fistula tract with fibrin-glue (Evicel®). The maximum amount of Evicel® injected will be 20 ml of the combined product.
~Surgical closure of inner (endoanal) fistula opening using a Z-suture (Vicryl 3.0)
~Surgical closure of the outer fistula opening using a Z-suture (Vicryl 3.0)
~Metronidazole and ciprofloxacin will be used at 500mg two times per day for 10 days after the intervention (baseline)."
15942533|NCT03322475|Device|PiQo4 laser system|The PiQo4 laser system
15942534|NCT03322462|Drug|Flortaucipir F18|370 megabecquerel (MBq) IV single-dose
15942535|NCT03322462|Procedure|Brain PET Scan|positron emission tomography (PET) scan of the brain
15942536|NCT03322449|Other|Animal Diet|during one week participants will receive food products enriched in animal products and with high content of fat and protein
15942537|NCT03322449|Other|Plant Diet|during one week participants will receive plant products enriched in fiber and complex carbohydrates
15942538|NCT03322436|Diagnostic Test|HeartLinc kit|Samples are collected and analyzed afterwards
15942539|NCT03322423|Device|Multifocal Contact Lens 1|Dailies Total 1 Multifocal Contact Lens
15942540|NCT03322423|Device|Multifocal Contact Lens 2|Biotrue ONEday for Presbyopia Contact Lenses
15942541|NCT03322423|Device|Spherical Contact Lens 2|BioTrue ONEDay Spherical
15942542|NCT03322410|Biological|modified Peritoneal Equilibration test|"Peritoneal permeability status determined by modified Peritoneal Equilibration test with complete drainage at 60 minutes as described for Twardowsky
~High : D/P creatinine>0,8; D/D0 glucose<0,25
~High average : 0,65< D/P creatinine <0,8; 0,25< D/D0 glucose <0,38
~Low average : 0,5< D/P creatinine <0,65; 0,39< D/D0 glucose < 0,48
~Low  : D/P creatinine<0,5 ; D/D0 glucose>0,49."
15942543|NCT03322397|Behavioral|Self-Focused Acts of Kindness Intervention|Participants engage in positive behaviors by completing acts of kindness for themselves three times per week. These acts should require effort and be outside of an individual's normal routine.
15942544|NCT03322397|Behavioral|Other-Focused Acts of Kindness Intervention|Participants engage in positive behaviors by completing acts of kindness for others three times per week. These acts should require effort and be outside of an individual's normal routine.
15942545|NCT03322397|Behavioral|Daily Reports|Participants will report their daily activities three times per week. Aside from reporting at the end of the day, no changes should be made to the individual's normal routine.
15942546|NCT03322384|Drug|epacadostat|Epacadostat will be administered orally, in pill form, twice daily until disease progression.
15942547|NCT03322384|Drug|SD-101|Four milligrams of SD-101 will be delivered into the treatment lesion by intralesional injection on days 1, 8, 15, 22, and 29.
15942548|NCT03322384|Radiation|Radiotherapy|Radiotherapy will be delivered to the treatment lesion during the first week of ERS therapy.
15942678|NCT03321253|Device|Nd: YAG laser posterior capsulotomy|Nd: YAG laser posterior capsulotomy
15942549|NCT03322371|Device|2-lead limited electroencephalography recording|The EEG recording device will be placed in conjunction with the standard formal polysomnography (PSG). The EEG device will remain in place as long as PSG leads are connected to the subject and PSG machine.
15942550|NCT03322358|Other|Naps|"After a baseline period, participants in this condition will be provided with the opportunity to nap in a quiet comfortable nap cabin in the study office for 30 minutes each afternoon on all work days."
15942551|NCT03322358|Device|Home sleep aids|After a baseline period, participants in this condition will be provided with a set of home sleep aids (e.g. earplugs, eyeshades, a basic mattress, sheets, and pillow, etc) to take home with them if they wish. These sleep aids and their proper use are described to the participants and they are encouraged to use them if they find them helpful.
15942552|NCT03322358|Other|Sleep incentives|After a baseline period, participants in this condition will be provided with a small payment for each additional minute of sleep over their mean nighttime sleep in the baseline period.
15942553|NCT03322319|Procedure|Tissue biopsies|"It is commonly accepted that the diagnosis of cardiac amyloidosis may be based on presence of characteristic cardiac abnormalities in echography, associated with the detection of bi-refractive appearance deposits in polarized light after congo red staining of a biopsy fragment.
~Usually a biopsy of the abdominal fat or salivary glands can suffice. More rarely, in case of persistent doubt (eg negativity of congo red despite a characteristic appearance, which may occur in 20 to 30% of cases), it will be necessary to perform an endomyocardial biopsy (EMB)."
15942554|NCT03322306|Genetic|Genechip screening kit|10 ml blood for genetic screening by specific genetic screening kit
15942555|NCT03322293|Drug|Aminolevulinic Acid Topical 20% Topical Solution|PDT involves the topical application of aminolevulinic acid (ALA), or one of its derivatives, as a photosensitizing agent. Subjects will receive ALA in all treatment arms (A, B, and C).
15942556|NCT03322293|Device|BLU-U blue light phototherapy illuminator|Depending on the treatment arm, subjects will either receive BLU-U exposure or not. Treatment arms A and B have BLU-U exposure and treatment arm C does not.
15942559|NCT03322267|Drug|Pembrolizumab|Cisplatin (30 mg/m2, QW, 2 cycles) and radiotherapy (18-26 Gy/10-13 fractions) as adjuvant chemoradiotherapy, followed by pembrolizumab (200mg, Q3W, 18 cycles)
15942560|NCT03322254|Other|respiratory pathogen panel|lab testing for respiratory pathogens
15942561|NCT03322241|Other|overall wellness|Wellness lab testing
15942562|NCT03322228|Other|Music Therapy|Music therapy is tailored to subject preference. Examples are active music-making, supportive listening, and includes opportunities for legacy building to decrease caregiver distress and promote self-care.
15942563|NCT03322215|Drug|Palbociclib|75-125 mg capsule orally once daily for 21 consecutive Days followed by 7 Days of treatment.
15942564|NCT03322215|Drug|Fulvestrant|500 mg intramuscularly Days 1 and 15 of cycle 1, and then on Day 1 of each subsequent 28-days cycle.
15942565|NCT03322215|Drug|Capecitabine|Oral tablet 500 - 1,250 mg/m2 twice Daily, for 2 weeks followed by 1 week of rest.
15942566|NCT03322202|Behavioral|Motivational Interviewing|Motivational Interviewing is a communication style that is intended to give patients the tools to reach goals through their own desires and actions.
15942567|NCT03322189|Genetic|pharmacogenomic|Standard Operating Procedures on Pharmacogenomic testing and changes made to specific SOP
15942568|NCT03322176|Other|Genetic testing|LYNCH genetic testing
15942569|NCT03322163|Other|Exposure is maternal iodine|The exposure is preconception maternal iodine status There is no intervention in this observational study
15942570|NCT03322150|Drug|Atropine|Atropine injection (0.01 mg/kg, max 0.5 mg) 3 minutes before spinal anesthesia
15942571|NCT03322150|Drug|Glycopyrrolate|Glycopyrrolate (0.00 4mg/kg, max 0.2 mg) 3 minutes before spinal anesthesia
15942572|NCT03322137|Drug|SNA-120|Pegcantratinib ointment
15942573|NCT03322137|Drug|Vehicle|Placebo ointment to mimic Pegcantratinib ointment
15942574|NCT03322124|Drug|Octenidinedihydrochlorid|Mouth rinsing of the oral cavity with Octenidinehydrochlorid vs.Placebo over a period of 5 days
15942575|NCT03322124|Other|Placebo|Mouth rinsing of the oral cavity with Octenidinehydrochlorid vs.Placebo over a period of 5 days
15942576|NCT03322111|Diagnostic Test|measurement of the cyclofusion|Measurement of the maximal cyclofusion competence with a dynamic 3-D Random-Dot Landolt-C stimulus
15942577|NCT03322098|Drug|Atropine|Atropine injection (0.01 mg/kg, max 0.5 mg) within 3 minutes before spinal anesthesia
15942578|NCT03322098|Drug|Glycopyrrolate|Glycopyrrolate (0.00 4mg/kg, max 0.2 mg) within 3 minutes before spinal anesthesia
15942579|NCT03322085|Procedure|radiofrequency ablation or cryoballoon|Patients in radiofrequency ablation group receive circumferential pulmonary vein isolation,and no additional ablation is performed in the extrapulmonary sites unless the patient is diagnosed with atrial flutter before the operation. And Cryoablation is performed using a single cryoballoon. The diameter of the cryoballoon is determined as 28 mm or 23 mm according to pulmonary venography results.
15942580|NCT03322072|Device|Real-Time Position Transponder Beacons|The anchored lung tracking beacons are passive electromagnetic transponder beacons which are placed immediately adjacent to a lung tumor using a bronchoscope. Three beacons will be placed in the small airways of the lung adjacent to the target tumor (within 3 cm of the tumor). Each beacon measures 2 mm in diameter and 8 mm in length and consists of a miniature electrical circuit that is encapsulated in a biocompatible glass capsule. Each beacon has an affixed five-legged anchoring system which expands to 5mm diameter once deployed. The Calypso transponder beacon is placed endobronchially using the working channel of a bronchoscope. Navigational bronchoscopy can be used to pre-plan the optimal location for each beacon to be placed within the airways by using a pre-bronchoscopy CT scan.
15942581|NCT03322059|Behavioral|Experimental|Participants will receive a fitbit and lifestyle counseling to increase steps. Weekly newsletter for first 6 weeks, bi-weekly for remaining weeks with behavioral content designed to increase physical activity (e.g., barriers, SMART goals). They will also receive a donation to a cancer charity of their choice if they meet daily step goals.
15942679|NCT03321240|Procedure|visual and quantitative SEEG signal analysis|signal SEEG analysis
15942582|NCT03322059|Behavioral|Control|Participants will receive a fitbit and lifestyle counseling to increase steps. Weekly newsletter for first 6 weeks, bi-weekly for remaining weeks with behavioral content designed to increase physical activity (e.g., barriers, SMART goals).
15942583|NCT03322046|Behavioral|Lifestyle Program|4 elements: 1) Laboratory test results with diagnostic report describing results, 2) Lifestyle plan generated in online portal with personalized nutritional information based on combination of laboratory results and personal preferences, 3) online or smartphone food journaling application, 4) telephone based lifestyle coaching with Registered Dietitian.
15942584|NCT03322033|Device|Valiant PS-IDE Stent Graft|Medtronic Valiant PS-IDE Stent Graft System with the Captivia Delivery System
15942585|NCT03322020|Radiation|Cyberknife boost 18 Gy|pelvis IMRT dose of 44 Gy/20 fx followed by Cyberknife boost 18 Gy/3 fx
15942586|NCT03322020|Radiation|Cyberknife boost 21 Gy|pelvis IMRT dose of 44 Gy/20 fx followed by Cyberknife boost 21 Gy/3 fx
15942587|NCT03321994|Device|stereotaxic unit, navigation|CT-guided needle guidance using stereotaxic unit, navigation
15942588|NCT03321994|Device|conventional biopsy technique|CT-guided needle guidance using conventional biopsy technique
15942589|NCT03321981|Drug|MCLA-128|full length IgG1 bispecific antibody targeting HER2 and HER3
15942590|NCT03321981|Drug|Trastuzumab|humanised IgG1 monoclonal antibody
15942591|NCT03321981|Drug|Vinorelbine|antineoplastic drug of vinca alkaloid family
15942592|NCT03321981|Drug|Endocrine therapy|same endocrine therapy is administered as the last line of endocrine therapy
15942593|NCT03321968|Biological|Quadrivalent VLP Influenza Vaccine|30 µg/strain Quadrivalent VLP Influenza Vaccine
15942594|NCT03321955|Drug|Ziconotide 100 MCG(microgram)/ML Intrathecal Solution|Initial dose at time of the implant will be 1.2 mcg/day with dose increases of no more the .4 mcg/day planned for 3, 6, 8, 9, 10, 12 weeks and 4, 5, 6 and 12 months.
15942595|NCT03321955|Diagnostic Test|Quantitative sensory testing|Quantitative sensory testing will be done using different types of sensory stimulation to objectively quantify sensation and pain tolerance. VonFrey fibers of various widths are used to detect sensation, a Neuropen pin prick iutilized to detect pain, along with a tuning fork to measure vibrationand a pressure guage to measure pressure felt on the skin. Cold/hot sensation is tested with Medoc Pathway system to quantitatively measure the temperature felt by patients to be done at baseline, 6 months and 12 months,
15942596|NCT03321955|Diagnostic Test|Serum markers: Interleukin-1, Interleukin-6, and tumor necrosis factor|Increases in these biomarkers indicate nerve pain as they are released from macrophages in patients with damaged nerves.
15942597|NCT03321942|Drug|Treatment group|Adipose tissue-derived mesenchymal stem cells were used to treat patients with chronic renal failure on the basis of conventional treatment.
15942598|NCT03321942|Drug|Control group|Conventional treatment were used to treat patients with chronic renal failure.
15942599|NCT03321929|Combination Product|LUM Imaging System|LUM015 will be administered 2 to 6 hours prior to surgery. All subjects will have intraoperative imaging using the LUM imaging device.
15942600|NCT03321916|Device|577-nm PASCAL laser|The Topcon/Endpoint Management System™ is a cleared medical device commonly used in the treatment of ocular disorders.
15942601|NCT03321903|Device|Carlo Erba Ink Injection|Carlo Erba India ink is used in this study as a paramagnetic oxygen sensor that is injected into tissue, and which, when measured using EPR Oximetry, can provide sensitive, repeated, and direct measurements of tissue oxygen. Each study participant will receive at least one ink injection of 20-50µL of Carlo Erba India Ink. The ink injection will occur within 5mm of the body surface (i.e., skin or mucosa), and may be injected into tumor, postsurgical field of radiation, and/or adjacent normal tissue. Carlo Erba Ink is an aqueous suspension composed of charcoal powder, water for injection, and a suspending agent. Carlo Erba is the name of the manufacturer that supplies the charcoal.
15942602|NCT03321903|Other|EPR Oximetry Measurement|An oximetry measurement visit consists of ~ 30 minutes of continuous scans of tissue oxygen in vivo, using an oxygen sensor (i.e., India ink) injected into the tumor that is noninvasively scanned using EPR oximetry. Scans, converted into measurements of pO2, characterize the current tumor oxygen level at: (1) 'steady state' (while breathing room air), 2) response to hyperoxygenation therapy (inhaling oxygen-enriched air for 10 min), and 3) response to resuming inhaling room air. EPR measurements are repeated noninvasively throughout radiation or chemotherapy, to examine changes. The minimum number of visits depends on the patient's cohort; all may have additional measurements. If the ink injection is not surgically removed, EPR oximetry measurements can be repeated indefinitely.
15942603|NCT03321890|Drug|Chidamide|Oral, each taking 30 mg (6 tablets), medication twice a week, 30 minutes after breakfast
15942604|NCT03321890|Drug|prednisone|oral, 20mg / day,after breakfast
15942605|NCT03321890|Drug|Cyclophosphamide|oral, 50mg / day,after lunch
15942606|NCT03321890|Drug|etoposide|oral, 50mg / day,after dinner
15942607|NCT03321890|Drug|Methotrexate|oral, 10mg / times, once a week,after breakfast
15942608|NCT03321877|Drug|Change to dose of patient's regular medication|Dose reduction of the drug each patient was already taking
15942609|NCT03321864|Procedure|Transrectal ultrasound scan of prostate|Additional transrectal ultrasound whilst already under GA for transperineal biopsy.
15942610|NCT03321851|Device|V-sensor device user|Participants use device to detect the 5 vital signs (Blood Pressure, Pulse, Respiration, SpO2, Temperature).
15942611|NCT03321838|Behavioral|accommodative/vergence therapy|Accommodative/vergence therapy (60 minutes per visit, one time per week, 12-14 weeks) and home reinforcement (15 minutes each time, five times per week, 12-14 weeks) will be provided to patients of treatment group. These therapy includes accommodative, vergence and anti-suppression technique. No drug is used during the whole therapy process.
15942612|NCT03321825|Device|Belotero® Volume Lidocaine|Mode of application: subdermal injection
15942613|NCT03321812|Procedure|decalcification bone scaffold|Decalcification bone scaffold is a tissue engineering acellular matrix scaffold with the closest biomechanics and structure of normal cartilage.
15942614|NCT03321812|Procedure|microfracture|Microfracture is the surgical option for conventional treatment of cartilage defects.
15942615|NCT03321799|Device|Negative Pressure Wound Therapy (NPWT)|A computer randomization system will be used on the day of surgery to allocate patients to either the conventional or NPWT dressing. Due to the nature of this study, blinding of patients and surgeons to their allocated cohort will not be possible.
15942617|NCT03321786|Other|The University of Pennsylvania Smell Identification Test (UPSIT)|"This standardized test, the most widely used olfactory test in the world, is derived from basic psychological test measurement theory and focuses on the comparative ability of subjects to identify odorants at the suprathreshold level. The UPSIT consists of four envelope-sized booklets, each containing ten scratch and sniff odorants embedded in 10- 50-µm polymer microcapsules positioned on brown strips at the bottom of the pages of the booklets."
15942618|NCT03321773|Drug|triple therapy plus bismuth therapy|pantoprazole 40mg twice daily for 14 days, amoxicillin 1g twice daily for 14 days, clarithromycin 500mg twice daily for 14 days, bismuth subcitrate 240mg twice daily for 14 days.
15942619|NCT03321773|Drug|reverse hybrid therapy|(pantoprazole 40mg twice daily for 7 days, amoxicillin 1 g twice dailyfor 7 days, clarithromycin 500 mg twice daily for 7 days, and metronidazole 500 mg twice daily for 7 days) followed by (pantoprazole 40mg twice daily for 7 days and amoxicillin 1 g twice daily for 7 days)
15942620|NCT03321760|Radiation|Stereotactic Ablative Radiation Therapy (SABR)|SABR will be delivered to the primary disease and hilar (N1) node over 5 fractions.Reductions may be made to the hilar (N1) node according to a 3+3 design during the run-in period.
15942622|NCT03321734|Drug|Caffeine|Infants will be started on oral caffeine base at 5 mg/kg/day. At 36 weeks + 0 days PMA drug dose will be increased to 5 mg/kg BID (total daily dose 10 mg/kg). Dose will be weight-adjusted weekly until NICU (neonatal intensive care unit) discharge. After discharge, all new doses will be calculated from the last weight recorded prior to discharge. The research pharmacy will prepare a bulk oral solution with active drug (caffeine base). While in the hospital, a daily 24-hour supply will be prepared and dispensed. For home administration of study drug, the research pharmacy at each clinical site will prepare and dispense a sufficient quantity of caffeine base solution for outpatient treatment up to 42 weeks + 6 days.
15942623|NCT03321734|Drug|Placebos|SyrSpend SF Unflavored will be used as the placebo for the control group infants. The volume of the placebo will match the volume of the study drug.
15942624|NCT03321721|Procedure|Suture for wound repair|Repair of wound with suture
15942625|NCT03321721|Device|Suture for wound repair|Repair of wound with suture
15942626|NCT03321682|Other|Functional Training|Exercises performed in circuit, using weights, elastic bands, suspension tapes, cones and on unstable surfaces.
15942627|NCT03321682|Other|Strength Training|Exercises carried out using weights and involving the main muscle groups.
15942628|NCT03321669|Procedure|Capsule endoscopy|Ingestion of capsule endoscopy for the diagnosis of small bowel lesions
15942629|NCT03321656|Drug|Tacrolimus|0.1-0.2 mg/kg/day orally divided into two doses every 12 hours orally
15942630|NCT03321656|Drug|Envarsus XR|0.07-0.14 mg/kg/day every morning orally
15942631|NCT03321643|Drug|Atezolizumab|Given IV
15942632|NCT03321643|Drug|Gemcitabine|Given IV
15942633|NCT03321643|Other|Laboratory Biomarker Analysis|Correlative studies
15942634|NCT03321643|Drug|Oxaliplatin|Given IV
15942635|NCT03321643|Biological|Rituximab|Given IV
15942636|NCT03321630|Drug|Lenvatinib|Lenvatinib 20 mg orally each day on days 1-7
15942637|NCT03321630|Drug|Pembrolizumab|Pembrolizumab 200mg intravenously, to be initiated on day 8, and continued every 3 weeks, in combination with daily lenvatinib 20 mg
15942638|NCT03321617|Drug|Pomaglumetad methionil|metabotropic glutamate 2/3 receptor (mGlu2/3R) agonist
15942639|NCT03321565|Other|Behavioral counseling and optional meal replacement program|Medical assessment and medical supervision of weight loss Measurements of metabolism and body composition Individualized exercise programs Personal training Support group meetings Individual psychotherapy A variety of nutritional plans including meal replacement options Nutrition education Long-term weight maintenance and relapse prevention programs
15942640|NCT03321552|Procedure|Percutaneous deep vein arterialization|Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
15942641|NCT03321552|Device|LimFlow System|Creation of an arterio-venous fistula in the below-the-knee vasculature using the LimFlow System endovascular, minimally invasive approach
15942642|NCT03321539|Drug|CCRT+GP|Patients receive concurrent cisplatin 100mg/m2 every 21days for three cycles during Intensity modulated-radiotherapy (IMRT) followed by adjuvant gemcitabine (1000mg/m2 on day 1 and day 8) and cisplatin (80mg/m2 on day 1) every 21 days for three cycles 4 weeks after radiotherapy.
15942643|NCT03321539|Drug|CCRT+PF|Patients receive concurrent cisplatin 100mg/m2 every 21 days for three cycles during Intensity modulated-radiotherapy (IMRT) followed by adjuvant cisplatin (80mg/m2 on day 1) and 5-fluorouracil (1000mg/m2 civ 96h) every 28 days for three cycles 4 weeks after radiotherapy.
15942644|NCT03321526|Drug|JNJ-42847922|Participants will receive JNJ-42847922 capsule orally.
15942645|NCT03321526|Drug|Placebo Matching to JNJ-42847922|Participants will receive placebo capsule matching to JNJ-42847922 orally.
15942646|NCT03321526|Drug|Quetiapine XR|Participants will receive quetiapine XR capsule orally.
15942647|NCT03321526|Drug|Placebo Matching to Quetiapine XR|Participants will receive placebo capsule matching to quetiapine XR orally.
15942648|NCT03321526|Drug|Selective Serotonin Reuptake Inhibitor (SSRI)|Participants will receive SSRI antidepressant (such as, citalopram, escitalopram, fluvoxamine, fluoxetine, paroxetine, sertraline, vilazodone or vortioxetine) as a part of background therapy (at the same dose, without change, every day and at approximately the same time as prior to entering the study) throughout the screening, double-blind, and follow-up phases (approximately up to Week 26).
15942649|NCT03321526|Drug|Serotonin-Norepinephrine Reuptake Inhibitor (SNRI)|Participants will receive SNRI antidepressant (such as duloxetine, milnacipran, levomilnacipran, venlafaxine, desvenlafaxine) as a part of background therapy (at the same dose, without change, every day and at approximately the same time as prior to entering the study) throughout the screening, double-blind, and follow-up phases (approximately up to Week 26).
15942680|NCT03321240|Procedure|Resective epilepsy surgery procedure|Surgical removal of the epileptogenic brain area
15942681|NCT03321227|Other|Snack skipping|No snack provided
15942682|NCT03321227|Other|Whole eggs|2 whole large eggs scrambled, provided as a snack
15942683|NCT03321227|Other|Egg whites|2 egg whites scrambled, provided as a snack
15942684|NCT03321227|Other|Egg yolks|2 egg yolks scrambled, provided as a snack
15942650|NCT03321513|Drug|intravitreous aflibercept|"Intravitreous aflibercept injection is made by Regeneron Pharmaceuticals, Inc. and is approved by the FDA for the treatment of neovascular age-related macular degeneration, macular edema due to central retinal vein occlusion, macular edema due to branch retinal vein occlusion, diabetic macular edema, and diabetic retinopathy in eyes with diabetic macular edema.
~Study eyes assigned to receive aflibercept will receive a dose of 2.0 mg in 0.05 cc. Aflibercept will be obtained commercially by the clinical site. The physical, chemical, and pharmaceutical properties and formulation of aflibercept are provided in the Package Insert.
~Intravitreous Injection Technique The injection is preceded by a povidone iodine prep of the conjunctiva. In general, topical antibiotics in the pre-, peri-, or post-injection period should not be used.
~The injection will be performed using sterile technique"
15942651|NCT03321513|Drug|Bevacizumab + Deferred Aflibercept Group|"Bevacizumab is made by Genentech, Inc. and is approved by the FDA for the treatment of metastatic colorectal cancer as well as the treatment of non-squamous non-small cell lung cancer, glioblastoma, and metastatic renal cell carcinoma.
~Study eyes assigned to receive bevacizumab will receive a dose of 1.25 mg provided by a single compounding pharmacy identified by the Network and distributed by the Network. The volume of the injections will be 0.05 cc.
~Intravitreous injection technique: The injection is preceded by a povidone iodine prep of the conjunctiva. In general, topical antibiotics in the pre-, peri-, or post-injection period should not be used.
~The injection will be performed using a sterile technique."
15942652|NCT03321500|Other|Versacryl soft liner|Versacryl has been used to construct different parts of complete and partial dentures . It can be used as thermo-elastic liner which consistency can be controlled to tailor the reline to each individual case, by adding or subtracting drops of liquid B, as explained in the directions for use. The reline can be re-adapted repeatedly, even by the patient if necessary.
15942653|NCT03321500|Other|Silicone-based soft liner|gold standard for denture relining material
15942654|NCT03321487|Device|Blood-Brain Barrier opening with MRgFUS|ExAblate Transcranial MR-guided Focused Ultrasound to temporarily open the Blood-Brain Barrier
15942655|NCT03321474|Procedure|modified gull wing preparation|"preparation is the inciso - proximal extension of porcelain laminates veneer margin more palatally.
~The preparation finished at the gingival margin and extended towards the papilla to finish the interproximal elbow preparation."
15942656|NCT03321461|Drug|TMTP1|Fluorescent sites will be removed
15942657|NCT03321461|Drug|ICG|Fluorescent sites will be removed
15942658|NCT03321448|Drug|TMTP1-ICG|Detection of SLN
15942659|NCT03321448|Drug|ICG|Detection of SLN
15942660|NCT03321435|Other|placenta previa patient|women had placenta previa either major or minor degree
15942661|NCT03321435|Other|normal women|those women had not placenta previa
15942662|NCT03321422|Other|No intervention Observational study|follow up of the function of the hip after lateral shelf acetabuloplasty by harris hip score and WOMAC score
15942663|NCT03321409|Diagnostic Test|The general population|After recruiting participants, collecting the baseline data, the SSS-CN and PHQ-15 will be carried out. Then validating the reliability, validity of the SSS-CN will be compared with the PHQ-15.
15942664|NCT03321409|Diagnostic Test|Patients with suspected CAD|In patients with suspected CAD, after recruiting participants, collecting the baseline data, the SSS-CN and PHQ-15 will be carried out before undergo coronary angiography. Then the prevalence of somatic symptoms will be investigated.
15942665|NCT03321396|Device|sodium alginate mixed with calcium lactate|"The product is used in Endoscopic submucosal dissection which is accomplished by steps listed as follows: lesion marking, submucosal injection, mucosal incision, submucosal dissection, then en-bloc resection. It's a new submucosal injection regimen, sodium alginate mixed with calcium lactate, which turned to calcium-alginate gel, we called it as Gut Guarding Gel."
15942666|NCT03321370|Diagnostic Test|Continuous electrocorticography post severe traumatic brain injury requiring neurosurgical intervention|Continuous electrocorticography via subdural electrode strips for 1 to 3 weeks in the neuro intensive care unit following traumatic brain injury
15942667|NCT03321357|Diagnostic Test|five-repetition sit-to-stand test|"An armless chair with a hard seat was stabilised by placing it against a wall. Seated participants were asked to come forward on the chair seat until the feet were flat on the floor and to fold their upper limbs across the chest. Participants were then instructed to stand up all the way and sit down once without using the upper limbs. For those unable to complete the initial manoeuvre or who required assistance, the test was terminated. If successful on the initial sit to stand, participants were then asked to stand up all the way and sit down landing firmly, as fast as possible, five times without using the arms. Timing with a stopwatch was started on the command 'go' and stopped at the end of the completed fifth stand; the time taken was recorded as the participant's score.
~(1) Jones et al."
15942668|NCT03321344|Device|Focused Ultrasound Thermal ablation|Focused Ultrasound Thermal ablation of the Medial Nerve Branch
15942669|NCT03321331|Combination Product|Lark (JITAI)|Lark works as a just-in-time adaptive intervention (JITAI), providing interactive counseling through a chat-style interface. The app prompts users to self-monitor, set goals, review them, provides feedback, and social support.
15942670|NCT03321331|Combination Product|MyFitnessPal (no JITAI)|MyFitnessPal (MFP) is a calorie counting app, which relies on user input for food tracking, but automatically tracks activity through the phone or through integrations with wearable devices. This app provides allows to set weight and caloric goals, review them and to receive feedback, but it has limited social support, a feature that is generally lacking in calorie-counting apps.
15942671|NCT03321318|Drug|AK-R215|Investigational product is prescribed to all ofrandomized subjects
15942672|NCT03321318|Drug|Bazedoxifene 20 mg|Investigational product is prescribed to all of randomized subjects
15942673|NCT03321318|Drug|Cholecalciferol 800IU|Investigational product is prescribed to all of randomized subjects
15942674|NCT03321292|Drug|L-arginine 1000 mg and Acetylesalicylic acid75mg|l-arginine 1000mg capsule will be given every 8 hours till delivery and acetylesalicylic acid75mg tablet once starting of diagnosis till birth.
15942675|NCT03321292|Drug|acetylsalicylic acid 75 mg|acetylsalicylic acid 75 mg will be given orally once daily for group B starting of diagnosis till birth.
15942676|NCT03321279|Behavioral|Social Incentive|Participants in the intervention arm will receive social incentives as part of the intervention. See arm descriptions for more detail.
15942677|NCT03321266|Device|Cook Biodesign® Fistula Plug|The Cook Biodesign® Fistula Plug is for implantation to reinforce soft tissue for repair of Anorectal fistulas.
15942686|NCT03321214|Other|Gluten Sensor Dose-Finding Intervention|"Nima is a small portable sensor that detects gluten in a small amount of liquid and solid foods in about three minutes. Nima combines an electronic sensor with antibody-based detection in a disposable capsule. Nima displays a smiley face if the food or beverage is < 20 ppm or a wheat icon for > 20 ppm (low or high gluten).
~Each of the 30 participants will receive a Nima along with 3 months of disposable capsules. At the baseline visit, research staff will provide participants with the Nima and capsules and review instructions on how to properly use the device with all participants."
15942687|NCT03321201|Procedure|Cauterization|To ensure the stability of the graft during cuttings, four sealing wraps will be installed, which will be removed after cauterisation is completed. Autograft and conjunctiva will be approximated by surgical forceps and will be cauterized using a bipolar cutter (Erbe ICC 50) with a force 1-3 / 20. Forceps will be released slowly to prevent elevation of the graft. The same procedure will be performed 10 times until graft is well firmed. Graft stability will be checked up with a sponge and additional cauterization will be preformed if needed.
15942688|NCT03321201|Procedure|Fibrin glue|Fiber adhesive (Tissel 1 mL kit4-iu) will be prepared according to manufacturer's instructions. Preparation time will be approximately 10-15 min per kit. Once mixed the fibrin glue is usable up to 4 h. For the purpose of the study preparation of the fibrin glue will be performed by a nurse.
15942689|NCT03321188|Procedure|HIPEC|HIPEC with cisplatin
15942690|NCT03321188|Drug|Carboplatin|Adjuvant IV chemotherapy
15942691|NCT03321188|Drug|Paclitaxel|Adjuvant IV chemotherapy
15942692|NCT03321175|Other|subcutaneous saline irrigation|200 cc saline irrigation
15942693|NCT03321162|Diagnostic Test|scan protocol|Scanning strategy is based on multiple scans. Essentially one CT scan of the patient (usually with a scan appliance). Another CT scan of the model or scan appliance may be required (double scan technique). Such a second CT scan can be replaced by optical scanning of the model and scan appliance (triple scan technique).
15942694|NCT03321149|Other|RiseTx|Participants were given access to the RiseTx application, as well as given a Jawbone, a wrist-worn device that can assess activity patterns throughout the day and provide sensory alerts to stand after prolonged sitting (i.e., ≥30 minutes of sedentary time). The intervention consisted of five phases following initial data collection that comprised of self-regulatory strategies to reduce sitting time and self-monitoring of step counts.
15942695|NCT03321136|Drug|LSD|0.025 mg LSD per os, single dose
15942696|NCT03321136|Drug|LSD|0.05 mg LSD per os, single dose
15942697|NCT03321136|Drug|LSD|0.1 mg LSD per os, single dose
15942698|NCT03321136|Drug|LSD|0.2 mg LSD per os, single dose
15942699|NCT03321136|Drug|LSD|0.2 mg LSD plus 40 mg ketanserin per os, single doses each
15942700|NCT03321136|Drug|Placebo|Capsules containing mannitol looking identical to the other drugs.
15942701|NCT03321123|Drug|MB-CART19.1|Miltenyi Biotec has established a semi-automated manufacturing process that can be made available to academic settings for systematic exploration of CAR strategies in advanced clinical studies. Closed-system operation, improved robustness, simplified work flows, and reduced labor intensity, while maintaining strict adherence to regulatory guidelines, allows for decentralized manufacturing. In this study, we will explore autologous 2nd generation CD19 CAR T cell products in patients with relapsed and refractory disease incurable with standard therapies.
15942702|NCT03321110|Other|Placebo|Placebo (dextrin)
15942703|NCT03321110|Dietary Supplement|Coenzyme Q10|150 mg or 300 mg
15942704|NCT03321097|Device|condensed RT group|"BoNT-A injections Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide.
~Training procedures There are total 24 training sessions following one week after injection. Participants in the condensed practice group will receive 4 sessions per week, for 6 weeks.
~During each practice session, participants first receive 40 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 40 minutes of transition-to-task practice."
15942705|NCT03321097|Device|distributed RT group|"BoNT-A injections Botox brand BoNT-A Purified Neurotoxin Complex, (Allergan Pharmaceuticals, Irvine, CA) will be prepared by diluting lyophilized toxin with 0.9% saline to a concentration of 33-100 U/ml. depending on the size of the target muscle. Location of the targeted muscle will be confirmed by using echo guide.
~Training procedures There are total 24 training sessions following one week after injection. Participants in the condensed practice group will receive 2 sessions per week, for 12 weeks.
~During each practice session, participants first receive 40 minutes of repetitive RT with the InMotion 3.0 robot (Interactive Motion Technologies Inc., Watertown, MA), followed by 40 minutes of transition-to-task practice."
15942706|NCT03321084|Other|MatPliates|The MatPilates program was specialized developed for this trial, in which all exercises belong to contemporaneous Pilates style. Each session has 60 minutes of duration, divided in three blocs (stretching, exercise and relaxation), with mean of 10, 40 and 10 minutes respectively (VIEIRA et al., 2016). Each exercise will be performed in one series of 10 to 15 repetitions and will be modified accordingly the patient need.
15942707|NCT03321084|Other|Control|Will not be submitted to any physical intervention. It continues in your daily life with only phone monitoring.
15942708|NCT03321071|Behavioral|Healthy Summer Learners|"Physical Activity Component. The physical activity component of Healthy Summer Learners is designed to engage children in moderate-to-vigorous physical activity (MVPA) for at least 50% of the time. With 3 hours each day dedicated to physical activity, this translates into children accumulating 90 minutes of MVPA daily. This is 30 minutes above the 60 minutes of MVPA each day recommended by the Physical Activity Guidelines for Americans.
~Nutrition Component. The nutrition component of Healthy Summer Learners is designed to provide healthy snacks and meals and nutrition education via standardized pre-existing curricula.
~Food/Beverage Guidelines. Meals will follow the USDA Nutrition Standards for the National School Lunch and School Breakfast Programs.
~Academic Component. The academic component will consist of existing, effective academic programs focused on Math and Reading."
15942709|NCT03321071|Behavioral|21st Century Summer Learning Center|Children in this condition will attend a 21st Century Summer Learning Program.
15942710|NCT03321058|Behavioral|Assessment|Assessment of patients' medication organisation and comprehension of generics
15942807|NCT03320317|Other|Learning session 1|Learn form international report, Explain key interventions, Explain BIC methodology, Retrospective patient record analysis, Team measures
15942711|NCT03321045|Drug|[89Zr]-Df-Trastuzumab|[89Zr]-Df-Trastuzumab will be administered intravenously. The administered dose will be 2 mCi at the time of injection. The amount of injected drug is 5 mg of Trastuzumab.
15942712|NCT03321045|Diagnostic Test|PET/MRI Imaging|5-6 days post injection the patients will undergo PET/MRI imaging.
15942713|NCT03321032|Device|Polymer-free amphilimus-eluting stents|Cre8 Evo coronary stent system (CID, Saluggia, Italy)
15942714|NCT03321032|Device|Biolinx Polymer-based zotarolimus-eluting stents|Resolute Onyx coronary stent system (Medtronic, Minneapolis, Minnesota, US)
15942715|NCT03321019|Drug|Capsaicin|Participants will inhale aerosolized capsaicin with the goal of this inducing cough and an urge-to-cough.
15942716|NCT03321019|Device|Resistive respiratory loads|Participants will breath through a mouthpiece. Every 3-5 breaths in, a respiratory load will be applied. Participants will be asked to rate the magnitude of the load.
15942717|NCT03321019|Other|Event-related evoked potential using electroencephalography (EEG).|The study team will use EEG time-locked to a respiratory occlusion to measure the brain's response to respiratory sensation.
15942718|NCT03321019|Procedure|Fluoroscopic swallow evaluation|Participants will swallow various consistencies of barium under fluoroscopy (moving-picture x-ray) in order to assess swallowing safety and efficiency.
15942719|NCT03321006|Device|Phonak Audeo B-R 90 hearing aid device (Active)|Hearing aids will be the latest Audeo B-R 90 devices manufactured by Phonak. Full amplification hearing aids will have their gain determined by audiometric profile as per standard clinical practice
15942720|NCT03321006|Drug|Duloxetine or escitalopram|We opted to allow two potential medication choices so that study participation could be offered to individuals who had previously taken one medication and either not responded or not tolerated it. After 4 weeks if subjects do not meet remission criteria (HRSD≤10), the dose of study medication will be increased to escitalopram 20mg or duloxetine 60mg for the remaining 8 weeks of the study.
15942721|NCT03321006|Device|Audeo B-R 90 hearing aid device (Sham)|Hearing aids will be the latest Audeo B-R 90 devices manufactured by Phonak. Low amplification hearing aids will be programmed to a hearing threshold of 10dB across all frequencies
15942722|NCT03320993|Other|Mixed meal with different macronutrient composition|A mixed meal with identical amount of carbohydrates but different content of protein, fat and alcohol will be given
15942723|NCT03320980|Procedure|RALPPS|RALPPS: split-in-situ resection with radio-frequency ablation (RFA) instead of liver partition on the first stage and major liver resection on the second stage
15942724|NCT03320980|Procedure|portal vein embolization + major liver resection|PVE on the first stage and major liver resection on the second stage
15942725|NCT03320967|Diagnostic Test|Copeptin in plasma|Copeptin will be measured in EDTA-Plasma. Samples will be stored for batch analyses later.
15942726|NCT03320954|Behavioral|Anomia treatment|Phase II participants will attend two-hour, group intervention sessions one day per week for eight weeks. Participants will engage in multiple word game activities throughout each intervention session. Games will include Facts in Five, Anomia, Boggle, and Bananagrams as well as variations on these, as appropriate.
15942727|NCT03320941|Drug|LIK066|LIK066 will be supplied in different doses as tablets to be taken orally daily.
15942728|NCT03320941|Drug|Placebo|Placebo will be supplied as tablets to be taken daily orally.
15942729|NCT03320928|Other|Photochemotherapy|Retrospective evaluation of treatment outcome and risk for pulmonary mortality and relapse incidence
15942730|NCT03320915|Drug|Cholecalciferol|Cholecalciferol 5mg (200,000 IU) up to maximum of three times during 1 year follow-up period according to measured 25(OH)D3 level.
15942731|NCT03320902|Behavioral|Sudden death counselling|"The Sudden Death Counselling with included relatives at 1 month (+/-15 days) after the eventafter the event will be at the Europeen Georges Pompidou hospital in Paris.
~The purpose of this Sudden Death Counselling is to provide to family members of sudden death victims information, support, referral and follow-up services relating to sudden death and their grief, if needed.
~The bereaved people will tell their experience. The Sudden Death Counselling would help them to integrate life's losses by companioning them.
~Cardiologist and psychologists will be present to listen to their pain and try to bring comfort by answering to their questionings."
15942732|NCT03320889|Other|Educational Intervention|Patients will be randomized to a group that receives the pamphlets only and a group that receives the pamphlets and has an expert educator review that pamphlets with them and answer questions.
15942733|NCT03320876|Drug|filgotinib|one filgotinib oral tablet once daily.
15942734|NCT03320863|Device|Enso device|An active Enso device that delivers neuromodulation therapy.
15942735|NCT03320850|Drug|OnabotulinumtoxinA and Hydrogel admixture|BOTOX® (onabotulinumtoxinA) and Hydrogel admixture administered as a single intravesical instillation
15942736|NCT03320850|Drug|Placebo and Hydrogel admixture|Placebo and Hydrogel admixture administered as a single intravesical instillation
15942737|NCT03320837|Dietary Supplement|Infant formula|Breast milk substitute containing synbiotics
15942738|NCT03320837|Other|Breast milk|Breast milk
15942739|NCT03320824|Device|New Dermal Filler|hyaluronic acid
15942740|NCT03320824|Device|Device: FDA Approved Dermal Filler|hyaluronic acid
15942741|NCT03320811|Other|Data record|
15942742|NCT03320798|Other|Data record|
15942743|NCT03320772|Drug|TMVP1-ICG|Detection of SLN
15942744|NCT03320772|Drug|ICG|Detection of SLN
15942745|NCT03320759|Behavioral|Occupational therapy rehabilitation|Participants in the experimental arm will receive occupational therapy that is individualized to each participant's needs from week 4 post-decompression surgery until week 12.
15942746|NCT03320746|Device|Polar Loop 2 activity tracker|"The participants were instructed to aim to reach the daily activity goal, initially set at stage 1 as per the goals set by the trackers' manufacturer. The daily activity goal was based on user's typical daily activities, gender and age. The stage 1 daily activity goal corresponded to ~1h/day of jogging or ~2h/day of walking or ~7h/day household activities or a combination of these activities. The tracker gave an inactivity alert as a vibration and text it's time to move on the screen of the tracker if the user has been still for 55 minutes."
15942808|NCT03320317|Other|Learning session 2|Feedback report, Share (inter)national best practices, Discussion, set priorities, teaching and improvement, Retrospective patient record analysis
15942874|NCT03319732|Drug|Arbaclofen|Arbaclofen is the active R enantiomer of baclofen.
15942747|NCT03320733|Diagnostic Test|Dual energy CT scan with subtraction imaging|"The single source V2R kmAS dual energy CT system has several theoretical advantages compared, such as perfectly matched X-ray paths and the possibility of performing dual-energy processing using projection data.
~Subtraction imaging is an accurate deformable registration algorithm that allows creation of iodine maps from matched pre- and post-contrast acquisitions. This algorithm can be applied to both single and dual energy CT."
15942748|NCT03320720|Other|Home Treatment|Patients with acute mental illness in need of inpatient care are treated at their houses by a mobile and multiprofessional care team if their health condition permits.
15942749|NCT03320720|Other|Treatment-as-usual|Patients with acute mental illness in need of inpatient care are treated in a psychiatric clinic.
15942750|NCT03320707|Drug|Daratumumab|Single SC dose of daratumumab will be administered in each of 8 dose cohorts.
15942751|NCT03320707|Drug|Placebo|Placebo liquid will be administered as SC dose in each of first 7 dose cohorts.
15942752|NCT03320707|Drug|rHuPH20|Participants in Cohort 8 will receive single SC dose of rHuPH20 as a part of daratumumab formulation.
15942753|NCT03320694|Drug|Metformin|metformin 500mg twice daily & increased until 2500mg till normoglycemia was achieved and was continued till delivery
15942754|NCT03320694|Drug|Insulin|The insulin group was given 3 S/C injections of regular insulin & one intermediate acting injection at night till normoglycemia was achieved and was continued till delivery
15942755|NCT03320681|Device|Electrical Stimulation|Percutaneous electrical nerve stimulation
15942756|NCT03320681|Other|Dry Needling Stimulation|Percutaneous nerve stimulation
15942757|NCT03320668|Other|Otago Exercise Program (OEP)|"A nurse/physiotherapist supported by an instructor-trained professional will give Otago Exercise Program (OEP) education to 10-people groups in 5 sessions (1st, 2nd, 4th and 8th week and one reinforcement session after 6 months). Telephone calls to participants will be made during non-training months (following a predefined telephonic interview protocol) to follow up. The OEP reduces the number of falls and fall-related injuries, improving balance and strength, confidence in performing everyday activities without falling. Whilst it has been shown to be effective in 4 controlled trials in New Zealand, it has not been tested in a primary care setting in Spain for feasibility, impact, acceptability and cost-effectiveness."
15942758|NCT03320655|Other|Combined Aerobic Training|The subjects will perform in ST part, always only 1 set in the 6 machines early mentioned. During the first and second week they will do 12 repetitions at 40% - 50% of 1 RM. In the third and fourth week progress to 10 repetitions at 60%-70% of 1 RM, and in the second and third month, 8 repetitions at 70%-80% of 1 RM. In the AT part the HIIT protocol is based on a ratio 2 min : 1 min. Consisted of 10 interval training periods (2 min of high intensity at 85% - 90% of heart rate reserve (HRreser) and 9 pauses (1 min in passive pause) between interval training periods. During the first week of training will start with a continuous training, in the second week will start with 5 intervals of HIIT, and in the second and third months they are doing the 10 stages of HIIT.
15942759|NCT03320655|Other|Combined Strength Training|During the first and second week subjects will perform 1 sets with 12 repetitions at 40% - 50% of 1 RM in the 6 machines mentioned before. In the third and fourth week strength exercises progress to 2 sets of 10 repetitions, at 60%-70% of 1 RM, and in the second and third month consists of 3 sets at 8 repetitions, at 70%-80% of 1 RM. . In the AT part the HIIT protocol is based on a ratio 2 min : 1 min. Consisted of of 5 interval training periods (2 min of high intensity: 85% - 90% of HRreser) and 4 pauses (1 min in passive pause) between interval training periods. During the first week of training will start with a continuous training, in the second week will start with 3 intervals of HIIT, and after the third/fourth week they are doing the 5 stages of HIIT.
15942760|NCT03320642|Drug|Itacitinib|Itacitinib administered orally once daily at the protocol-defined dose.
15942761|NCT03320642|Drug|Calcineurin inhibitor|The CNI-based prophylaxis regimen will be identified by the investigator before the subject's enrollment and will consist of the combination of tacrolimus/methotrexate, cyclosporine A/mycophenolate mofetil or tacrolimus plus post-treatment cyclophosphamide. Antithymocyte globulin may be included at the treating investigator's discretion with the tacrolimus/methotrexate or cyclosporine A/mycophenolate mofetil combinations.
15942762|NCT03320629|Combination Product|apatinib S-1 radiotherapy|apatinib 500mg qd po S-1 40-60mg/time bid po d1-14 q3w radiotherapy 50-60Gy/25-30times until disease progression or intolerable toxicity or patients withdrawal of consent
15942763|NCT03320629|Combination Product|S-1 radiotherapy|S-1 40-60mg/time bid po d1-14 q3w radiotherapy 50-60Gy/25-30times until disease progression or intolerable toxicity or patients withdrawal of consent
15942764|NCT03320616|Drug|EYP001a|Oral EYP001a capsules - 100 mg strength
15942765|NCT03320603|Other|Expert eCRF|An expert eCRF will be used to guide physicians during the management of patients treated with Vitamin K Agonist or Direct Oral Anticoagulant admitted in emergency units for severe bleeding.
15942766|NCT03320603|Other|Prothrombin Complex Concentrate|Prothrombin Complex Concentrate given as standard of care
15942767|NCT03320590|Diagnostic Test|Time Lapse (material to observe embryonic development)|The embryonic kinetics are recorded by Time lapse Primovision™ (Vitrolife). These kinetic parameters are analysed and annotated by only one person with expertise in this technology.
15942768|NCT03320577|Behavioral|Class instruction of breathing exercises|Pranayama Breathing exercises practiced at least 5 times a week and log practice times
15942769|NCT03320577|Behavioral|DVD instruction of breathing exercises|Pranayama Breathing exercises practiced at least 5 times a week and log practice times
15942770|NCT03320577|Behavioral|Control|Log dinner times
15942771|NCT03320564|Diagnostic Test|F-18 FDG PET|Repeat scan performed by specially trained staff to reduce risk of repeat infiltration.
15942772|NCT03320551|Behavioral|Immersion program|Evaluate the impact of an already established one week long lifestyle immersion program sponsored by Whole Foods, Inc for their employees on anthropomorphic, clinical labs such as lipid levels, blood sugar and other markers of nutrition, quality of life and activity levels at baseline, at the end of the program and at 3 and 6 months
15942773|NCT03320538|Other|Hou Gu Mi Xi|Hou Gu Mi Xi is an oatmeal-liked, solid food (dry or dissolved eating).
15942774|NCT03320538|Other|Placebo|The placebo is as same as Hou Gu Mi Xi in respect of color, taste, and smell.
15942775|NCT03320538|Drug|Rabeprazole|Rabeprazole is produced by Shanghai Xinyi Pharmaceutical Corp. Ltd.
15942776|NCT03320525|Dietary Supplement|T-ChOS|T-ChOS 600 mg (two capsules, each 300 mg) daily in the morning 30 minutes before food.
15942777|NCT03320512|Behavioral|P3|P3 is an interactive smartphone app that utilizes social networking and game-based mechanics to improve PrEP adherence and persistence in PrEP care. The participant will install P3 on their phone, receive a guided tour of the app and a reminder card with the research coordinator's phone number and email address and instructed to contact the research coordinator immediately to report difficulties with any app components or to report any problems with their phone or phone service. A help link is embedded within the app that directly links to study staff if assistance is needed. P3 arm participants will have 24-hour access to all features of P3.
15942778|NCT03320512|Behavioral|P3+|In P3+, participants receive all of P3 and the ability to text in the app with an adherence counselor, using Next Step Counseling (NSC). NSC is an interactive, client-centered motivational intervention to improve PrEP adherence. Key components of NSC include: review experiences with adherence, exploration of adherence facilitators and barriers, identification of adherence needs, identification of strategies to meet needs, and development of an adherence action plan. Participants will install P3+ on their phone. The adherence counselor feature will be unlocked for those in the P3+ arm. P3+ participants will have 24-hour access to all features of P3+.
15942779|NCT03320512|Behavioral|Control|Control participants will receive the standard of care for receiving a prescription for PrEP.
15942780|NCT03320499|Procedure|echo doppler at the bed|we practise the echo doppler at the patient 's bed
15942781|NCT03320499|Procedure|echo doppler in the vascular exploration platform|as usual , practising echo doppler in the medical platform
15942782|NCT03320486|Drug|Dapaconazole|Application of 1 to 3 grams, depending on the lesion extension, per affected foot.
15942783|NCT03320486|Drug|Ketoconazole|Application of 1 to 3 grams, depending on the lesion extension, per affected foot.
15942784|NCT03320473|Device|IC-8 IOL|The AcuFocus IC-8 intraocular lens (IC-8 IOL) is a one-piece hydrophobic acrylic posterior chamber IOL into which a circular mask with a small 1.36 mm central aperture has been embedded. The IOL mask works by extending the depth of focus and its design is based on the KAMRA corneal inlay, which operates under the principle of small aperture optics.
15942785|NCT03320460|Drug|Propionate clobetasol gel 0.05%|Patients will be treated with Propionate clobetasol gel 0.05% for 30 consecutive days and with placebo laser twice a week. Patients will be instructed to apply the propionate clobetasol gel 0.05% in the entire lesion three times/days. To prevent oral candidiasis, patients will use micostatin solution (Nystatin oral suspension 100,000 USP/ml) once a day during 4 weeks.
15942786|NCT03320460|Device|Photobiomodulation|Patients will be treated with localized PBM with a diode laser with continuous wave (laser λ = 660 nm; power 100mW;radiant energy: 177J/cm2; 5-s exposure time per point and 0.5J of energy per point) applied directly to the surrounding oral mucosa and to the center of OLP, always by the same operator, twice a week for 4 weeks, totaling 8 session. The number of points will be variable according to the lesion size. The output power of the laser equipment will be evaluated using a power meter (Laser Check; MMOptics LTDA, São Paulo, Brazil) before treatment to confirm the effective mean power as well as the doses applied during the procedure.
15942787|NCT03320460|Other|Placebo gel|Placebo gel for 30 consecutive days to mask the treatment
15942788|NCT03320460|Other|Placebo Photobiomodulation|Laser device will be positioned over the lesion but will be switched off to mask the treatment.
15942789|NCT03320447|Drug|lidocaine-prilocaine 5% cream application|The lesions were then cleansed with saline gauze, and a lidocaine-prilocaine 5% cream (EMLA®; Astra Pharmaceuticals, LP, Westborough, MA, USA) was applied to the treatment area for 30 min under occlusion
15942790|NCT03320447|Device|2940-nm Er:YAG AFL pretreatment|After the anesthetic cream was removed, AFL was performed using a 2940-nm Er:YAG AFL (Joule; Sciton, Inc., Palo Alto, CA, USA) with a 500 µm ablation depth, level 1 coagulation, 22% treatment density, and a single pulse
15942791|NCT03320447|Drug|methyl-aminolevulinate application|Immediately after the AFL, a 1-mm thick layer of methyl-aminolevulinate (16% Metvix® cream; PhotoCure ASA, Oslo, Norway) was applied to the lesion and to 5 mm of the surrounding healthy tissue. The area was covered with an occlusive dressing (Tegaderm; 3M, Co., Saint Paul, MN, USA) for 3 h, after which the remaining cream was removed with saline gauze, and the red fluorescence of porphyrins was visualized with Wood's light.
15942792|NCT03320447|Device|Illuminating using red light-emitting diode lamps|Each treatment area was then separately illuminated using red light-emitting diode lamps (Aktilite CL128; Galderma S.A., Bruchsal, Germany) with peak emission at 632 nm and a total light dose of 37 J/cm2. Areas scheduled to receive MAL-PDT received the second treatment 7 days later. During the illumination, patients were asked to evaluate pain intensity using an 11-point visual analog scale.
15942793|NCT03320434|Drug|PRT-2761 0.5%|Six drops in each eye over a 17 day period.
15942794|NCT03320434|Drug|PRT-2761 1%|Six drops in each eye over a 17 day period.
15942795|NCT03320434|Drug|Patanol|Six drops in each eye over a 17 day period.
15942796|NCT03320434|Drug|Pred-forte|Four drops in each eye over a 3 day period.
15942797|NCT03320434|Drug|PRT-2761 0%|Six drops in each eye over a 17 day period.
15942798|NCT03320421|Radiation|Radiation therapy|"Radiation to the whole breast: 43.5 Gy in 15 fractions in 3 weeks. Simultaneous radiation to the surgical cavity: 49.5 Gy in 15 fractions in 3 weeks.
~Intensity modulated radiation treatment is used."
15942799|NCT03320395|Device|Small bowel RFA treatment|"The samples will be spread and fixed using needles. The prototype RFA-SB ablation catheter will be applied by the PI as follows to each section of duodenum, jejunum and ileum.
~The treating paddle of the prototype RFA-SB catheter will be pushed on the small bowel mucosa exerting the same pressure that would be applied endoscopically.
~12 J/cm2 will be applied every time with a 20 second interval between applications to simulate clinical practice.
~There will be two single applications to two separate specimen sites. There will be two double applications to two separate specimen sites. There will be two triple applications to two separate specimen sites. There will be two quadruple applications to two separate specimen sites."
15942800|NCT03320382|Device|Multiple breath washout testing|Multiple breath washout testing will be completed on different devices over time
15942801|NCT03320369|Other|Elemental Diet Therapy|Elemental diet is a formula composed of amino-acids, carbohydrates, and lipids that is 100% nutritionally complete
15942802|NCT03320356|Other|the French version of the Oxford Shoulder Score|
15942803|NCT03320343|Other|MRI|3D morphological MRI and diffusion tensor imaging
15942804|NCT03320330|Other|Laboratory Biomarker Analysis|Correlative studies
15942805|NCT03320330|Biological|Pepinemab|Given IV
15942809|NCT03320317|Other|Learning session 3|Feedback report, Share best practices, Discussion, set priorities, teaching and improvement, Retrospective patient record analysis, Team measures
15942810|NCT03320317|Other|Learning session 4|Feedback report, Best practice symposium
15942811|NCT03320304|Device|Vagal Nerve Simulation (VNS) Therapy|A VNS Therapy System used for vagus nerve stimulation and consisting of an implantable VNS Therapy generator, lead, and external programming system.
15942812|NCT03320291|Device|Regjoint|Implant of poly-L / D-lactide (Regjoints®) in the treatment of trapezo-metacarpal osteoarthritis
15942813|NCT03320265|Drug|PC-mAb|Monthly treatment for 3 months (4 administrations)
15942814|NCT03320265|Drug|Placebo|Monthly treatment for 3 months (4 administrations)
15942815|NCT03320252|Device|Endurant Chimney Graft Technique|Medtronic Endurant II and Endurant IIs Stent Graft Systems and balloon-expandable covered stent graft systems approved for use in the renal arteries. These devices will be utilized in a chimney graft configuration.
15942816|NCT03320239|Behavioral|HIV risk assessment and tailored suggestions|The intervention contains: HIV risk investigation, tailored suggestions and free HIV testing link
15942817|NCT03320239|Behavioral|HIV risk behavior assessment|It only contains HIV risk behavior assessment and routine education
15942818|NCT03320239|Behavioral|placebo control|It only contains HIV/AIDS knowledge assessment and routine education
15942819|NCT03320226|Dietary Supplement|Probiotic 10 (Nature's Bounty)|The Probiotic 10 (Nature's Bounty) that contains 20 billion live cultures of Lactobacillus plantarum 299v (Lp299v®), Lactobacillus bulgaricus Lb-87, Lactobacillus paracasei DSM 13434, Lactobacillus plantarum DSM 15312, Lactobacillus salivarius Ls-33, Lactobacillus brevis Lbr-35, Lactobacillus acidophilus La-14, Bifidobacterium lactis Bl-04, Lactobacillus paracasei Lpc-37, Lactobacillus casei Lc-11, which are under Lactobacillus and Bifidobacterium.
15942820|NCT03320200|Other|CNS-focused treatment|The CNS-focused treatment will last for 10 weeks, conducted in 60-minute sessions on a weekly basis. In addition, participants in this group will complete a home treatment program for 30 minutes, five times a week.
15942821|NCT03320200|Other|Standard Care Treatment|The standard physiotherapy group will receive a 10-session treatment program that will include one corticosteroid infiltration provided in the early acute stage followed by a multimodal physiotherapy program including analgesic modalities (e.g. TENS, cryotherapy) and exercise and manual therapy techniques addressing the specific mobility deficits of each patient. This program also include a home treatment based on conventional physiotherapy that involves a training load comparable to that in the CNS-focused group.
15942822|NCT03320187|Drug|Nitroderm TTS|Transdermal nitroglycerin 5mg skin patch
15942823|NCT03320187|Drug|Dinoprostone|Dinoprostone 3gm vaginal tablet will be used as the study method of labor induction
15942824|NCT03320174|Drug|Tafenoquine|Tafenoquine 200mg
15942825|NCT03320174|Other|Placebo|Placebo
15942826|NCT03320148|Behavioral|Physiotherapist-led primary care model for back pain|"Assessment and screening: taking a history; screening for red flags, comorbidities, and risk factors of ongoing pain and disability; physical examination
~Brief individualized intervention at the first visit: effective communication, cognitive reassurance, a few exercises, and advice/strategies to stay active.
~Health services navigation: PT assistance with navigating healthcare services based on the assessment findings. First, red-flags requiring emergency or urgent referrals. Next, comorbid conditions that would benefit from care from other healthcare providers. Finally, referral to PT (if appropriate).
~Providing additional physiotherapy care to people with an unmet need: Additional physiotherapy care will be provided to patients who have an identified need for physiotherapy but no physiotherapy coverage through private or government health insurance plans."
15942827|NCT03320148|Other|Usual care|The physician led primary care intervention will be unstandardized to best reflect standard clinical practice in Canada.
15942828|NCT03320135|Procedure|Enamel matrix derivative proteins|Open flap debridement to enamel matrix derivative to treat proximal furcation involvements.
15942829|NCT03320135|Procedure|Open Flap debridement|Open flap debridement will be performed to decontaminate the proximal furcation involvements.
15942830|NCT03320122|Other|Telemedicine|Medical direction will be provided to MTUs through a video-based conferencing unit. Each telemedicine unit includes a Rubbermaid medical grade cart with a Polycom RealPresence 500 Series high-resolution video-conferencing unit flat screen to display video. Each cart also comes with an Uninterrupted Power Supply (UPS) to make the unit mobile if needed or to properly shut it down in the event of power failure.
15942831|NCT03320122|Other|In-Person Pediatric Physiatrist|UC Davis pediatric physiatrists will drive out to the school-based MTUs to provide medical direction in person.
15942832|NCT03320122|Other|In-Person Non-Pediatric Physiatrist|A contracted physician (i.e., a non pediatric physiatrist) would provide medical direction in person.
15942833|NCT03320109|Other|Vitamin D|
15942834|NCT03320096|Device|Microfocused ultrasound with visualization|Subjects will receive 2 treatments (day 1 and day 30), each at a 3.0mm depth and 0.30 Joule of energy. Treatment will be delivered in a 3*4 grid, 12 treatment squares, delivering 60 lines of treatment per square, i.e., 720 lines per axilla in each treatment (1440 lines total per treatment.)
15942835|NCT03320083|Behavioral|Educational care derived from POSSUMS|Intervention group were offered a sleep education session on healthy practices for parent-baby sleep which included information on sleep needs, sleep hygiene, training in strategies to remove obstacles that get in the way of healthy sleep. Information were provided to guide the parent in forming an action plan based on cued care which included aligning the circadian clock with real time, removing the obstacles that get in the way of healthy sleep, physical activity, mindfulness, and relaxation techniques for mothers derived from the POSSUMS approach. However, we could not use Acceptance and Commitment Therapy, because none of the investigators had sufficient training on ACT at the time the study was conducted.
15942838|NCT03320057|Drug|Mifepristone|Patients will receive Mifeprex® (mifepristone) by pharmacy rather than standard care at clinic visit
15942839|NCT03320057|Other|Training on mifepristone dispensing|Pharmacists were offered a training on medication abortion and mifepristone dispensing
15942840|NCT03320031|Drug|Linagliptin|Take linagliptin 5mg a day.
15942841|NCT03320031|Drug|Humalog Mix 75/25|Administer subcutaneous premixed insulin twice a day.
15942842|NCT03320018|Drug|Hydrogen|Hydrogen will be infused into bags of normal saline solution and administered intravenously, or infused into water for the patient to drink, as the patient's condition permits. This will be administered q 8 hours for 3 days.
15942843|NCT03320018|Drug|Minocycline|"Minocycline 200 mg will be mixed with normal saline and given by i.v. administration, or provided as capsules for the patient to swallow, q 24 hours for 5 days.
~Once patients regain the ability to swallow capsules, minocycline will be given orally in capsule form (2 capsules of 100 mg each), administered once daily for the remainder of the 5 day period."
15942844|NCT03320018|Other|Placebo Hydrogen|Normal saline solution or water will be administered i.v. or p.o. respectively, in place of hydrogen solution.
15942845|NCT03320018|Other|Placebo Minocycline|Normal saline solution or placebo capsule will be administered i.v. or p.o. respectively, in place of minocycline.
15942846|NCT03320005|Other|Resistance training group|Resistive exercises for legs and arms
15942847|NCT03319992|Device|Upper Arm Rehabilitation Light Exoskeleton (RH-LEXOS)|RH-LEXOS is a robotic exoskeleton device to support the rehabilitation of stroke patients. This system is conceived for the force assistance, integrated in a Virtual Reality system that allows implementing rehabilitative exercises highly interactive and engaging for the patients. Passive, assisted and active mobilization of upper arm is provided through the use of the exoskeleton robotic device within high intensive, repetitive, task-oriented exercises and an objective and reliable mean for monitoring patients' progress.
15942848|NCT03319953|Drug|TAK-041|TAK-041 suspension
15942849|NCT03319953|Drug|Placebo|TAK-041 placebo-matching suspension
15942850|NCT03319953|Drug|Second Generation Antipsychotics (SGA)|Second generation antipsychotics included risperidone, paliperidone, iloperidone, quetiapine, olanzapine, ziprasidone, asenapine and lurasidone.
15942851|NCT03319940|Drug|AMG 757|AMG 757 is a Half Life Extended (HLE) Bispecific T cell engager (BiTE®) targeting delta-like protein 3 (DLL3)
15942852|NCT03319940|Drug|Pembrolizumab|Pembrolizumab is a potent humanized IgG4 monoclonal antibody (mAb) with high specificity of binding to the PD-1 receptor, thus inhibiting its interaction with PD-L1 and PD-L2
15942853|NCT03319940|Drug|CRS Mitigation Strategies|Subjects will be treated with one of the CRS mitigation strategies.
15942854|NCT03319927|Behavioral|IPM educational workshop and consultation|The interventions include a baseline assessment conducted by a research assistant and objective measures of pesticide exposure (center dust samples, children's silicone wristbands), review of assessment by the nurse child care health consultant, goal setting with the director, educational workshop, 7 monthly consultation visits, and post-intervention review of goals and post-assessment findings (conducted by research assistant and objective measures of pesticide exposure).
15942855|NCT03319901|Drug|Venetoclax|"Venetoclax is an inhibitor of Bcl-2. Bcl-2 is critical for keeping cancer cells alive.
~By inhibiting Bcl-2, venetoclax promotes cancer cell death."
15942856|NCT03319901|Drug|Standard Chemotherapy|Standard treatment of chemotherapy is administered
15942857|NCT03319888|Device|CPAP|continuous positive pressure in the airway
15942858|NCT03319888|Other|conservative treatment|conservative treatment group with lifestyle modifications
15942859|NCT03319875|Device|Epiduroscopic Laser Discectomy|Caudal epidural space after passing through sacral hiatus
15942860|NCT03319862|Procedure|Inferior pédicule gynaecomastia|Inferior pédicule gynaecomastia
15942861|NCT03319849|Combination Product|NT-501|Surgery to receive one NT-501 device implant.
15942862|NCT03319849|Procedure|Sham|Non-penetrating sham procedure to mimic implant procedure.
15942863|NCT03319823|Drug|Thiazide Treatment Group|"Thiazide Treatment Group: Non-diabetics with sleep systolic blood pressure of 125-139 mm Hg and awake systolic blood pressure <160 mm Hg Participants will be treated with Indapamide 0.625mg once a day After 4 weeks of treatment, the investigators will monitor chemistries/electrolytes with a fingerstick point of care device and repeat ambulatory blood pressure monitoring the investigators will repeat ambulatory blood pressure monitoring at 4, 8, and 12 weeks after treatment initiation.
~If sleep systolic blood pressure is < 120 mm Hg, the investigators will continue treatment"
15942864|NCT03319823|Drug|Intensified Thiazide Treatment Group|At 4 weeks of therapy, individuals initially assigned to the Thiazide treatment group whose ambulatory blood pressure recheck showed a sleep systolic blood pressure >120 mm Hg, the investigators will intensify their blood pressure medications by adding on Telmisartan 40 mg and Amlodipine 5 mg. In two week intervals, labs and ambulatory blood pressure will be measured. If the systolic blood pressure >120, then the doses of Telmisartan and Amlodipine will be up-titrated until the sleep systolic blood pressure is <120.
15942865|NCT03319823|Drug|Combination Medication Treatment Group|"Combination Medication Treatment Group: Diabetics or sleep systolic blood pressure of ≥ 140 mm Hg, or awake systolic blood pressure of ≥ 160 mm Hg
~Participants will be treated with starting doses of a long acting blood pressure regimen of Telmisartan 40 mg and Amlodipine 5 mg daily
~After 2 weeks, the investigators will monitor chemistries/electrolytes with a fingerstick point of care device and repeat ambulatory blood pressure monitoring
~If sleep systolic blood pressure is < 120 mm Hg, the investigators will continue treatment and repeat ambulatory blood pressure again in another 2 weeks to assess reproducibility
~If sleep systolic blood pressure is > 120 mm Hg, the investigators will increase Telmisartan dose to 80 mg and the Amlodipine dose to 10 mg. Ambulatory blood pressure monitoring will be checked again after 2 weeks of therapy to verify efficacy."
15942866|NCT03319810|Biological|Octagam 10%|FDA approved human normal immunoglobulin solution ready for intravenous administration
15942867|NCT03319797|Drug|NOVOCART® Inject plus|Treatment with NOVOCART® Inject plus (Autologous chondrocyte implantation)
15942868|NCT03319784|Drug|Ketorolac|Patients assigned to Toradol group will receive a single dose of 60mg of Ketorolac (Toradol) mixed with 8mL of 1% lidocaine with epinephrine 1:100,000.
15942869|NCT03319784|Drug|Triamcinolone Acetonide|Patients assigned to Steroid group will receive 80mg of Triamcinolone Acetonide (Kenalog) mixed with 8mL of 1% lidocaine with epinephrine 1:100,000.
15942870|NCT03319771|Behavioral|Treadmill Walking Exercise Training|12-weeks of supervised, progressive treadmill walking exercise training
15942871|NCT03319771|Behavioral|Stretching-and-toning Exercise Training|12-weeks of supervised, stretching-and-toning exercise training
15942872|NCT03319758|Procedure|buccal bone augmentation|Subjects in need of one implant replacing tooth to be removed in the maxilla within region 13-23 are included. At least 15 patients are recruited.
15942873|NCT03319745|Biological|Pembrolizumab|Given IV
15942875|NCT03319719|Device|Belotero® Balance with integral lidocaine|Mode of application: intradermal injection. Maximum treatment volume: 3 mL per nasolabial fold over two Treatment sessions.
15942876|NCT03319719|Device|Belotero® Balance|Mode of application: intradermal injection. Maximum treatment volume: 3 mL per nasolabial fold over two Treatment sessions.
15942877|NCT03319706|Drug|Torrent's Olmesartan Medoxomil Tablets 40 mg|
15942878|NCT03319706|Drug|Daiichi Sankyo Inc's Benicar Tablets 40 mg|
15942879|NCT03319693|Genetic|Somatic Genetic|NGS analysis
15942880|NCT03319680|Other|Citrate dialysate|Compare the effect of citrate dialysate with acetate dialysate
15942881|NCT03319667|Drug|Isatuximab SAR650984|"Pharmaceutical form: Solution for infusion
~Route of administration: Intravenous (IV)"
15942882|NCT03319667|Drug|Bortezomib|"Pharmaceutical form: Lyophilized powder for injection
~Route of administration: Intravenous/Subcutaneous"
15942883|NCT03319667|Drug|Lenalidomide|"Pharmaceutical form: Capsules
~Route of administration: Oral"
15942884|NCT03319667|Drug|Dexamethasone|"Pharmaceutical form: Tablets, ampoules or vials for injection
~Route of administration: Oral/Intravenous"
15942885|NCT03319667|Drug|Acetaminophen (paracetamol) or equivalent|"Pharmaceutical form: Tablets
~Route of administration: Oral"
15942886|NCT03319667|Drug|Ranitidine or equivalent|"Pharmaceutical form: Solution for injection
~Route of administration: Intravenous"
15942887|NCT03319667|Drug|Diphenhydramine or equivalent|"Pharmaceutical form: Solution for injection
~Route of administration: Intravenous"
15942888|NCT03319654|Diagnostic Test|DNA fragmentation by TUNEL assay|Direct DNA fragmentation testing with terminal deoxyuridine nick end labeling (TUNEL) assay.
15942889|NCT03319641|Diagnostic Test|PSMA-PET/CT scan|perform a PSMA-PET/CT scan in patients with locally advanced, recurrent and/or metastastic ACC or SDC
15942890|NCT03319628|Drug|upifitamab rilsodotin|"XMT-1536 will be administered once every 28 days until disease progression, unacceptable toxicity, or either the patient or study physician determines it is in the best interest of the patient to discontinue participation in the study.
~For sites participating in the sub-study, patients with platinum -resistant ovarian cancer will have the option to enroll in this sub-study to evaluate potential changes in the QTc interval following administration of XMT-1536"
15942891|NCT03319615|Behavioral|Dietary energy restriction|
15942892|NCT03319602|Device|Double trunk mask add above a nasal canulae|oxygenation only with nostril prongs
15942893|NCT03319589|Dietary Supplement|Supplement|locally prepared biscuit with low sugar content (less than 10% weight) designed to facilitate growth and cognitive development
15942894|NCT03319576|Other|Feeding at 4 hours|Patients will be fed 4 hours after their gastrostomy tube placement procedure.
15942895|NCT03319563|Drug|Local anesthetic-epinephrine|"Bupivacaine 0.5% (Astra Zeneca) 2 mg/Kg.
~Lidocaine 5 mg/Kg.
~Epinephrine 5 mcg/ml of the total volume.
~Add normal saline to a total volume of 100 ml/10 cm of the wound length."
15942896|NCT03319563|Drug|Saline|normal saline 100 ml/10 cm of the wound length
15942897|NCT03319550|Dietary Supplement|Casein|see experimental description
15942898|NCT03319550|Dietary Supplement|Whey|see experimental description
15942899|NCT03319550|Dietary Supplement|Leucine-enriched whey|see experimental description
15942900|NCT03319537|Drug|pevonedistat|Pevonedistat will be administered as an IV infusion at a dose of 50 mg/m2 days 1, 3, and 5 of a 21-day cycle.Treatment will be administered as an outpatient.
15942901|NCT03319537|Drug|Pemetrexed and cisplatin|Pemetrexed, 500 mg/m2 and cisplatin, 75 mg/m2, will be given at fixed doses on day 1 of each cycle.
15942902|NCT03319511|Other|spinal group|plain bupivacaine 0.5%,1.5 ml plus dexmedetomidine 5 μg. once injection.
15942903|NCT03319511|Other|paravertebral group|plain bupivacaine 0.5%, 0.3 ml (1.5 mg)/kg plus dexmedetomidine 0.5 μg /kg divided between the T2 and T4 levels.
15942904|NCT03319498|Other|Peppermint Oil Vapor|"2ml of the oil will be placed in the urine collection hat that fits into the bowl of the toilet. Participants will then sit on the toilet in normal fashion, exposing their perineum to the vapor of the oil. The perineum will NOT come into contact with the oil directly - only the vapor from the oil will contact the perineum."
15942905|NCT03319498|Other|Mineral Oil Vapor|"2ml of the mineral oil will be placed in the urine collection hat that fits into the bowl of the toilet. Participants will then sit on the toilet in normal fashion, exposing their perineum to the vapor of the oil. The perineum will NOT come into contact with the oil directly - only the vapor from the oil will contact the perineum."
15942906|NCT03319485|Device|ExAblate Pallidotomy|ExAblate Pallidotomy for Parkinson's Disease
15942907|NCT03319485|Device|Sham ExAblate Pallidotomy|ExAblate MRgFUS Sham Procedure
15942908|NCT03319459|Drug|FATE-NK100|FATE-NK100 is a donor-derived NK cell product comprised of ex vivo activated effector cells with enhanced anti-tumor activity
15942909|NCT03319459|Drug|Cetuximab|Epidermal growth factor receptor inhibitor antineoplastic agent
15942910|NCT03319459|Drug|Trastuzumab|HER2/neu receptor inhibitor
15942911|NCT03319433|Device|Perfusion Index|Use of non-invasive pulse oximeter to determine perfusion index
15942912|NCT03319420|Drug|LO2A eye drops|Sodium hyaluronate
15942913|NCT03319420|Drug|Systane Ultra UD|Active Ingredients; Polyethylene Glycol Propylene Glycol
15942914|NCT03319407|Device|EPAD monitoring system|EPAD system will be used as part of routine care
15942915|NCT03319394|Behavioral|The First Twenty|The First Twenty workouts were part of an online training program that provided resistance and endurance exercises, nutritional information, and mental performance guidance. The intervention, created by firefighters for firefighters, was a 10-week periodized program with workouts increasing in frequency and intensity each week.
15942916|NCT03319394|Behavioral|Comparison|Documentation of having previously taken or concurrent enrollment in a 1 credit hour fitness class offered through the community college. HPER 240, Lifetime Fitness, introduced the student to basic fitness principles, physical activity and the relationship to a healthy lifestyle. The course was graded based on an initial assessment/orientation and participation; the student was required to log hours at the community college gym. This course was waived at the discretion of the Fire Academy Director if the student proved they had an active gym membership at a local gym facility.
15942917|NCT03319381|Behavioral|Following new SOPs|The new SOPs comprised early whole-body CT, damage control surgery, and the use of goal-directed coagulation management and are based on the ATLS® concept, which was the strictly followed protocol before implementation of the new SOPs
15942918|NCT03319368|Other|Targeted gown and glove use|Gown and glove use for high risk care activities in high risk residents
15942919|NCT03319355|Behavioral|cognitive behavioral therapy|exercise therapy
15942920|NCT03319342|Behavioral|Behavioral Intervention|Perform acts of kindness to others
15942921|NCT03319342|Behavioral|Behavioral Intervention|Perform acts of kindness to self
15942922|NCT03319342|Behavioral|Behavioral Intervention|Perform self-kindness meditation
15942923|NCT03319342|Behavioral|Behavioral Intervention|Keep track of daily activities
15942924|NCT03319342|Other|Questionnaire Administration|Ancillary studies
15942925|NCT03319329|Device|Indirect Calorimetry|REE measurements were using IC (Cosmed, Quark RMR 2.0, Indirect Calorimetry Lab, Italy). A standard protocol for conducting the measurement was followed (Schlein & Coulter, 2014);(P. Singer & Singer, 2016); (Taku Oshima et al., 2016). Before each measurement, the metabolic monitor was allowed to warm up for 30 min, and then gas and flowmeter calibrations were performed by an experienced dietitian or healthcare professional. The REE was recorded after a 30 min non-fasting steady state according to RMR protocol and manufacturer instructions.
15942926|NCT03319316|Drug|Durvalumab|Combination of durvalumab + tremelimumab treatment
15942927|NCT03319316|Drug|Tremelimumab|Combination of durvalumab + tremelimumab treatment
15942928|NCT03319290|Genetic|BRCA1 and BRCA2|Genetic breast and ovarian cancer testing
15942929|NCT03319277|Other|Decreased opiate prescription|The experimental group will receive 5 tablets of oxycodone 5mg at time of discharge with a paper backup prescription for an additional 10 tablets.
15942930|NCT03319277|Other|Routine opiate prescription|The comparator group will receive 28 tablets of oxycodone 5mg at time of discharge.
15942931|NCT03319264|Other|Dynamometry exam|Prehension strength of the main hand will be assessed thanks to dynamometry, in order to evaluate patient's muscular strength
15942932|NCT03319264|Other|Walking test|A 4 metres walking test will be performed to assess patient's walking speed
15942933|NCT03319264|Radiation|DXA measurement|DXA measurement will be performed to assess patient's body composition
15942934|NCT03319264|Other|SARQOL questionnaire|Patient's quality of life will be assessed thanks to the SARQOL questionnaire
15942935|NCT03319264|Behavioral|Life habits Questionnaire|Life habits Questionnaire
15942936|NCT03319238|Other|ketamine|The aim of this study is to evaluate the safety of use, benefits and risks of repeated use of ketamine for each patient with chronic pain in different structures of pain management.
15942937|NCT03319212|Device|senofilcon A contact lenses|Senofilcon A Daily Disposable Contact Lenses
15942938|NCT03319199|Dietary Supplement|"SLIM WATER"|2 grams of L- CARNITINE and 150 mg MAGNESIUM for a duration of 16 weeks
15942939|NCT03319199|Other|Placebo - water|for a duration of 16 weeks
15942940|NCT03319186|Procedure|EDIT Management|"EDIT management
~Volumetric Pleural MRI for pre-aspiration pleural cavity volume
~Large volume pleural aspiration with recording of intra-pleural pressure during aspiration
~Volumetric Pleural MRI for post-aspiration pleural cavity volume
~Computation of PEL250, defined as the rolling average of pleural elastance over the preceding 250ml aspirated.
~MaxPEL250 ≥ 14.5 cm H2O/L: allocated to 1st-line IPC MaxPEL250 < 14.5 cm H2O/L: allocated to 1st-line TP
~EDIT-directed 1st-line treatment to be delivered within 24 hours; if insufficient residual pleural fluid to allow standard Seldinger insertion technique then Boutin-type needle used for pneumothorax induction and guide wire insertion."
15942941|NCT03319186|Procedure|Chest drain and talc pleurodesis|Intercostal chest drain insertion and talc slurry instillation according to British Thoracic Society guidelines
15942942|NCT03319173|Behavioral|Dietary intervention|"Subjects in the experimental group will receive clinically regulated meal plans designed to facilitate prolonged benign dietary ketosis (BDK) in order to regulate glucose with restored insulin sensitivity focused at reversing the impaired capacity to switch between fat and carbohydrate oxidation.
~Subjects in the control group will follow the their current dietary protocol (Standard American Diet-SAD)."
15942943|NCT03319160|Device|Defibrillation|Wearable Cardioverter Defibrillator
15942944|NCT03319147|Dietary Supplement|Active|4g of essential amino acids
15942945|NCT03319147|Dietary Supplement|Placebo|4g of maltdextrin
15942946|NCT03319134|Device|active anodal HD-tDCS|1) active anodal HD-tDCS with memory task
15942947|NCT03319134|Device|sham HD-tDCS|2) sham HD-tDCS with memory task
15942948|NCT03319134|Device|active cathodal HD-tDCS|3) active cathodal HD-tDCS with memory task
15942949|NCT03319121|Drug|Empirical therapy group|Receive extended release lansoprazole (Dexlansoprazole, Takeda Pharmaceuticals, Japan) 60 mg daily for 2 weeks.
15942950|NCT03319121|Drug|Guided therapy group|Receive Dexlansoprazole 30 mg daily for GERD, 60 mg daily for GERD with erosive esophagitis for 8 weeks and Theophylline SR 250 mg daily for functional chest pain for 4 weeks.
15942951|NCT03319108|Other|Exercise|Pulmonary Rehabilitation Program for 8 weeks
15942952|NCT03319095|Device|Intravaginal Electrical Nerve Stimulation|The Intervention group will receive Intravaginal Electrical Nerve Stimulation using Quark® Dualpex equipment, once per week during 8 weeks. The selected current will be biphasic, and the stimulation parameters will be: 50 Hz frequency, pulse width of 200 microseconds, contraction time (Ton) of 5 seconds, relaxation time (Toff) of 10 seconds, intensity of current defined according to the sensitivity (tolerance) of the patient, and total stimulation time of 20 minutes once a week delivered by an experienced Physiotherapist. In the last 10 minutes of each electrical nerve stimulation session women will be requested to perform voluntary PFM contractions along with the contractions induced by the electrical stimulation. Women will not be instructed to perform any aditional exercise or therapy at home.
15942953|NCT03319082|Combination Product|Corneal Collagen Cross-linking|Photrexa Viscous (riboflavin 5'-phosphate in 20% dextran ophthalmic solution), Photrexa (riboflavin 5'-phosphate ophthalmic solution), and the KXL System (UV Irradiation).
15942954|NCT03319069|Radiation|Hypofractionated radiotherapy|"Hypofractionated radiotherapy 43,5 GY/15 fractions (f)/3ws. to chest wall and supraclavicular nodal region.
~."
15942955|NCT03319069|Radiation|Conventional fractionated radiotherapy|50 Gray(GY)/ 25f/5 weeks(5w) to chest wall and supraclavicular nodal region
15942956|NCT03319056|Other|Air purifier|active- or sham-mode air purifier used in 6 classrooms in a school with a crossover design
15942998|NCT03318705|Device|RS3000Adv|Nidek RS3000Adv device to be used to take images which will allow measurement of vascularization in participants
15942957|NCT03319043|Drug|Chanqin granules|All patients enrolled in the research are treated with Budesonide + Formoterol Fumarate dry powder (160/4.5ug bid) for inhalation. Patients in treatment group are given additional Chanqin granules 10g three times a day; and analogous for the controlled group.
15942958|NCT03319017|Procedure|Multiple-trauma patients|"The blood samples of the patients who agreed on this research are obtained in order to check their inflammatory response factor, and then their medical records are checked to find their initial ABGA result, lactate, C-reactive protein(CRP) known as initial inflammatory response, and procalcitonin.
~A patient's whole blood is collected in the tube with ethylene diaminetetracetic acid (EDTA) treatment. A modified method of Boyum's technique is applied so as to separate polymorphonuclear neutrophils. The separated polymorphonuclear neutrophils is collected so as to check apoptosis. And then, in the separated plasma, interleukin(IL)-6 and tumor necrosis factor(TNF)-α are measured, and its correlation with oxygen saturation will be analyzed."
15942959|NCT03319004|Device|apply phase lag entropy sensor|apply phase lag entropy sensor as well as bispectral index sensor on forehead during the sedation using propofol
15942960|NCT03318991|Procedure|Laser prostatectomy|Patients with symptomatic benign prostate obstruction (BPO) will be assigned under randomisation to treat with GreenLight laser or thulium laser.
15942961|NCT03318978|Drug|[14C]-benzo[a]pyrene|Oral micro-dose range (25, 50, 100 and 250 ng)
15942962|NCT03318952|Drug|lidocaine|A buccal infiltration injection followed by 2-3 interpapillary injections and possibly more if needed of 2% lidocaine with 1:100,000 epinephrine will be administered.
15942963|NCT03318952|Drug|articaine|A single buccal infiltration injection of 4% articaine with 1:100,000 epinephrine will be administered
15942964|NCT03318939|Drug|Poziotinib|"The poziotinib drug substance is a hydrochloride salt of poziotinib and is formulated as a tablet for oral administration.
~Cohorts 1-3: 16 mg QD
~Cohort 4: 8 mg BID
~Cohort 5: randomized to 8 mg BID or 6 mg BID or 10 mg QD
~Cohorts 6 and 7: 8 mg BID"
15942965|NCT03318913|Other|Placebo|5g of the sucralose administered as white plastic capsules
15942966|NCT03318913|Other|Fish protein hydrolysates|5g of the FPH dissolving in 100 mL of water
15942972|NCT03318887|Drug|Sofosbuvir/daclatasvir with or without ribavirin|Direct-acting antiviral treatment for hepatitis C virus infection
15942973|NCT03318874|Device|Blephasteam|Steam delivery goggles, once daily
15942974|NCT03318874|Device|THERA°PEARL Eye Mask|Heat delivery device, delivering heat to the eyelids, once daily
15942975|NCT03318874|Drug|Hylo-comod|Tear substitute containing hyaluronic acid, four times daily
15942979|NCT03318848|Other|Video during simulation|The intervention group simulated the bed bath while watching the video, under the supervision of the tutor
15942980|NCT03318835|Drug|Thalidomide combined with R-CHOP|rituximab 375 mg/m2,ivgtt D1 cyclophosphamide 750 mg/m2 iv D2 vincristine 1.4 mg/m2 [capped at 2.0 mg], iv D2 doxorubicin 50 mg/m2 iv D2 prednisone 100 mg/m2 per day PO D2-6 Thalidomide 200mg PO QN D1-21
15942981|NCT03318835|Drug|R-CHOP|rituximab 375 mg/m2,ivgtt D1 cyclophosphamide 750 mg/m2 iv D2 vincristine 1.4 mg/m2 [capped at 2.0 mg], iv D2 doxorubicin 50 mg/m2 iv D2 prednisone 100 mg/m2 per day PO D2-6
15942982|NCT03318822|Device|Q-Collar|An externally-worn medical device that applies mild jugular compression
15942983|NCT03318809|Drug|AMG 986|tablets for oral administration
15942984|NCT03318796|Device|Coronary Artery Stenting|Interventional coronary artery stent placement in De novo bifurcation lesions of the MB & SB
15942985|NCT03318783|Drug|GSK2256294|GSK2256294 will be administered in a single dose once daily enteral for a duration of 10 days.
15942986|NCT03318783|Drug|Placebo|Placebo will be administered in a single dose once daily enteral for a duration of 10 days.
15942987|NCT03318770|Drug|Dasatinib and blinatumomab|Patients treated frontline with the sequential administration of dasatinib and the bispecific monoclonal antibody blinatumomab according to the protocol LAL2116
15942988|NCT03318757|Drug|Bupivacaine Extended Release Liposome Injection|Bupivacaine Extended Release Liposome Injection (Exparel TM) 133 mg diluted in 10ml of normal saline (13.3 mg/ml) will be injected with a 25 gauge needle directly into the gingiva surrounding the surgical site at the conclusion of surgery.
15942989|NCT03318757|Drug|Bupivacaine HCl|10ml of Bupivacaine HCl 0.5% will be injected with a 25 gauge needle directly into the gingiva surrounding the surgical site at the conclusion of surgery.
15942990|NCT03318744|Drug|Aspirin|Aspirin is one of the most widely used antithrombotic agents to prevent recurrent ischemic stroke for patients with prior symptomatic ischemic stroke.
15942991|NCT03318744|Drug|Placebo Oral Tablet|Placebo resembling aspirin tablet will be be given to participants in control arm.
15942992|NCT03318731|Other|Sugar Pill|Taken orally in capsule form
15942993|NCT03318731|Dietary Supplement|Fenugreek Extract, Low Dose|Taken orally in capsule form
15942994|NCT03318731|Dietary Supplement|Fenugreek Extract, High Dose|Taken orally in capsule form
15942995|NCT03318718|Drug|Anesthesia with non-depolarizing NMBA Rocuronium|Non- depolarizing NMBA Rocuronium will be used until full paraspinal muscle Relaxation. Muscle relaxation during surgery will be performed using intraoperative boli intermediate duration non-depolarizing NMBA, rocuronium (0.3 mg/kg) until good surgical conditions are achieved.
15942996|NCT03318718|Diagnostic Test|TOF measurement|TOF (Train-of-four) measurements will be performed at baseline 5 minutes after induction after the effect of succinylcholine will have run off. Moreover, TOF measurements will be performed 5 minutes after each rocuronium bolus
15942997|NCT03318718|Diagnostic Test|MEP measurement|MEPs (motor evoked potentials) are routinely obtained after intubation and before surgery, then every 10min during the critical preparation and closing phases of surgery and every 5min during the correction phase. In addition MEPs will be measured after the administration of the NMBA rocuronium. Baseline values for amplitudes and latencies are obtained directly prior to the start of the correction phase of the surgery.
15943032|NCT03318419|Drug|G-CSF|300ug d0-14
15942999|NCT03318692|Procedure|spondylodesis|Dorsal instrumentation with transpedicular screws (spondylodesis)
15943000|NCT03318692|Procedure|CT|CT of operated area is performed within 7 days of surgery
15943001|NCT03318679|Other|No intervention is planned.|None is planned
15943004|NCT03318640|Behavioral|Mindfulness|Patient will have 8 sessions (1h30) of mindfulness based on Kabat-Zinn program during one month
15943005|NCT03318627|Device|Sterile Spring Scale|Measuring intraoperative tension of tendon of rotator cuff tear
15943006|NCT03318614|Dietary Supplement|Probiotics M-63|B. infantis M63 (2.5 x 109 cfu/g per sachet) was given to Probiotics M-63 group for three months.
15943007|NCT03318614|Other|Control group|No probiotic intervention was given to the control group for three months.
15943008|NCT03318601|Procedure|Blood taking|"Blood taking in 2 times :
~J0 : 15 mL
~J14 : 5 mL 20 mL in total volume"
15943009|NCT03318588|Procedure|Vitrectomy|Pars plana vitrectomy
15943010|NCT03318575|Device|autoRIC|Automated Remote Ischemic Conditioning
15943011|NCT03318575|Device|autoRIC Sham|Automated Remote Ischemic Conditioning Sham
15943012|NCT03318562|Drug|eFT508|200 mg eFT508 dosed BID for 3 week cycles
15943013|NCT03318549|Diagnostic Test|Visual Performance tests|The overall goal of this proposal is to improve our understanding of functional disability in glaucoma by using virtual reality tests to investigate objective performance during simulated daily life activities.
15943014|NCT03318549|Device|Brain-computer interface for assessment of multifocal steady-state visual evoked potentials|The brain-computer interface (BCI) device consists of a modified virtual reality goggle integrated with wireless no-prep electroencephalogram (EEG). The portable BCI is able to objectively measure multifocal steadystate visual evoked potentials in response to brain stimulation through presentation of visual stimuli in the goggle.
15943015|NCT03318536|Drug|Granisetron Hydrochloride|Patients received Granisetron.
15943016|NCT03318536|Drug|No Granisetron|Patients who did not receive Granisetron.
15943017|NCT03318523|Drug|Placebo|Administered as specified in the treatment arm
15943018|NCT03318523|Drug|BIIB054|Administered as specified in the treatment arm.
15943019|NCT03318510|Device|Laser Speckle Flowgraphy|A commercially available LSFG system (LSFG-NAVI; Softcare Co., Ltd., Fukuoka, Japan) will be used in the present study. The LSFG device consists of a fundus camera equipped with a diode laser with a wavelength if 830 nm and charge-coupled device.
15943020|NCT03318497|Drug|3'-deoxy-3'-[F-18] fluorothymidine: [F-18]FLT|Given IV The experimental 18F-FLT-PET/CT is required to be completed before initiation of chemotherapy. Labs and correlative radiology, as directed per clinical care, are required within 30 days prior to 18F-FLT-PET/CT; and 18F-FDG-PET/CT is required within 30 days before the 18F-FLT-PET/CT. Follow-up will comprise 24 months of standard practice treatment and follow up.
15943021|NCT03318497|Procedure|Computed Tomography|Undergo PET/CT
15943022|NCT03318497|Procedure|Positron Emission Tomography|Undergo PET/CT
15943023|NCT03318497|Other|Laboratory Biomarker Analysis|Correlative studies
15943024|NCT03318484|Drug|Optimal Medical Care|Aspirin 100mg once a day, Atorvastatin 20mg once a day and Antihypertensive Agents if necessary.
15943025|NCT03318484|Combination Product|Sonodynamic therapy|SDT treatment is the combination of sonosensitizer administration and target atherosclerotic lesions ultrasound exposure. Sinoporphyrin sodium (DVDMS) as sonosensitizer, is dissolved in 0.9% sodium solution for following skin test and intravenous injection. 0.01mg/ml DVDMS solution (0.1ml) is prepared for skin test followed by 0.04 mg/ml DVDMS solution intravenous injection (0.2mg/kg). The target atherosclerotic lesions are marked on the corresponding skin with ultrasound guidance and underwent ultrasound exposure after 4 hours incubation. The therapeutic ultrasonic transducer is fixed to the marked skin site for 15min of each lesion. Ultrasound parameters included intensity of 1.8W/cm2 for femoral lesions, resonance frequency: 1.0 MHz and duty factor: 30%.
15943026|NCT03318471|Drug|MgSo4|50 mg/kg MgSo4 in 100 ml 0.9 sodium Chloride 15 minutes prior to anesthesia induction over 15 minutes
15943027|NCT03318471|Drug|0.9% NaCl|100 ml 0.9% NaCl 15 minutes prior to anesthesia induction over 15 minutes
15943028|NCT03318458|Other|Pilates|The duration of the intervention is 12 weeks, with 2 sessions per week of Pilates. Each session lasts approximately 1 hour and is structured in three parts: initial warm-up, which reviews the basic principles of the Pilates Method (centralization, concentration, movement control, breathing, movement precision and fluency) of 10 minutes duration, a 40-45 minute Pilates session and finally 10 minutes of guided relaxation. No complement was used (magic rings, fitball, elastic bands, etc.) during classes
15943029|NCT03318445|Drug|Rucaparib|All participants will take rucaparib by mouth
15943030|NCT03318445|Drug|Irinotecan|Patients in the dose escalation phase, and patients in the dose expansion phase who have received prior PARP inhibitor therapy, will be given irinotecan by in combination with rucaparib.
15943031|NCT03318419|Drug|Cladribine|5mg/㎡ d1-5
15943035|NCT03318406|Device|Bronchoscopic thermal vapor ablation|Bronchoscopic vapor delivery to airway segment(s) targeted for treatment
15943036|NCT03318393|Drug|Bivalirudin|Continuous infusion
15943037|NCT03318393|Drug|Unfractionated heparin|Continuous infusion
15943039|NCT03318367|Other|Educational Intervention|Complete virtual reality education module
15943040|NCT03318354|Drug|Torrent's Olmesartan Medoxomil Tablets 40 mg|
15943041|NCT03318354|Drug|Daiichi Sankyo Inc's Benicar Tablets 40 mg|
15943042|NCT03318341|Device|Real Stimulation|The device applies wrist vibration at a subthreshold (imperceptible) level.
15943043|NCT03318341|Device|Sham Stimulation|The device applies no vibration.
15943044|NCT03318328|Other|survey|
15943045|NCT03318315|Drug|AS03|AS03 oil-in-water emulsion adjuvant.
15943046|NCT03318315|Biological|Inactivated influenza H7N9 vaccine|Monovalent 2017 H7N9 inactivated influenza vaccine
15943047|NCT03318315|Biological|Influenza Virus Quadrivalent Inactivated Vaccine|A seasonal quadrivalent inactivated influenza vaccine (IIV4), prepared from influenza viruses propagated in embryonated chicken eggs, protecting against 2 influenza A subtypes (H1N1 and H3N2) and 2 influenza B subtypes (B Yamata lineage and B Victoria lineage).
15943048|NCT03318315|Other|Phosphate Buffered Saline (PBS) diluent|Diluent for Adjuvanted 2017 Monovalent Inactivated Influenza A/H7N9 vaccine (2017 H7N9IIV)
15943049|NCT03318302|Other|Survey|Survey of the adult population in Israel
15943050|NCT03318289|Behavioral|Ving Tsun|The VT training regimen is designed to improve reactive balance control, lower extremity muscle strength and balance confidence in the elderly. It comprises 9 VT sticking-hand drills that must be practised with a partner. Participants will be trained to respond rapidly to upper body perturbations and to maintain body balance. Those joined the VT training group will attend a one-hour supervised VT training session at an elderly community centre 2 times per week for 12 weeks.
15943051|NCT03318276|Drug|SID142|SID142 is administrated to patients with PAD for 12 weeks
15943052|NCT03318276|Drug|Rinexin® Tab|Rinexin® Tab is administrated to patients with PAD for 12 weeks
15943053|NCT03318263|Diagnostic Test|next-generation sequencing (NGS)|ESR1, PI3KCA and AKT extensive exon sequencing will be performed using NGS (Miseq Illumina) at the Biopathology department, Institut de Cancérologie de Lorraine (ISO15189 certified lab). Samples taken at baseline (t0), at progression (tp) and 3 months before progression (tp-3) will be systematically analyzed. The intermediate samples will be stored and kept for additional studies. Follow up assessment will be performed according to prescriber's directions.
15943054|NCT03318250|Device|Dorsal Root Ganglion Stimulation|During the Dorsal Root Ganglion implant , SCS leads will be implanted using a TransGrade Dorsal Root Ganglion Technique. Antibiotic prophylaxis is performed prior to surgery for both trial and permanent implant phase. Using the technique lead placement will be performed through a small skin incision under local anaesthesia supplemented by conscious sedation. The leads will be placed along the DRG to obtain stimulation coverage over as much of the pain area as possible. After the leads have been implanted, x-ray or fluoroscopy images will be taken to record the final lead locations. Once intervention is completed participants will assigned either DRG-LF and Burst3D device programme.
15943055|NCT03318224|Other|none (observational study)|only assessments via questionnaires, no interventions
15943056|NCT03318211|Drug|Magnesium Sulfate|Intravenous ampules of MgSo4 was given to only to control group after delivery
15943057|NCT03318198|Other|Enhanged Attending Supervision|Attendings were randomized at the start of the study to begin in the enhanced supervision arm where they attended resident work rounds. They then crossed over to the control arm where they did not attend work rounds. The outcomes were assessed between the two periods during which the attending participated in the study; attending work rounds vs. not attending work rounds.
15943058|NCT03318198|Other|Standard of Care|Attendings participated directly in new patient rounds but did not see patients previously known to the team with the residents.
15943059|NCT03318185|Procedure|gasless single-port laparoscopic surgery|The single-port laparoscopic surgery is performed when the maneuvering room is provided by external suspension system.
15943060|NCT03318185|Procedure|conventional laparoscopic surgery|The multi-port laparoscopic surgery is performed when the belly is inflated with carbon dioxide to provide maneuvering room.
15943061|NCT03318172|Device|Spinal Cord Stimulator|Implantation of spinal cord stimulator in patients included in the study and divided in conventional and high density stimulation groups
15943062|NCT03318159|Drug|Posaconazole|"Dosing of posaconazole Posaconazole tablet 300 mg twice daily on day 1; Maintenance dose: 300 mg once daily on day 2 and thereafter. Treatment period: 4 weeks
~*if posaconazole tablet intolerance: posaconazole suspension 200mg tid"
15943063|NCT03318146|Device|drug delivery system|The EXP-LP sustained released formula inserted into a small punctual plug. The plug is designed to release the drug over a period of up to 6 months in a slow release profile.
15943064|NCT03318146|Drug|XALATAN®|one drop in the affected eye(s) once daily in the evening
15943065|NCT03318133|Procedure|anesthesia|in this study, we plan to make a prospective, multicenter, randomized controlled clinical trial to compare the effects of general anesthesia with endotracheal intubation and ultrasound-guided combined lumbar plexus and sacral plexus block with sedative anesthesia on the prognosis of elderly patients with hip fracture to clarify the clinical value of combined lumbar plexus and sacral plexus block with sedative anesthesia in elderly patients with hip fracture.
15943066|NCT03318120|Behavioral|Progressive Resistance Training|Participants will perform required resistance training exercises at regular intervals for a period of up to 3 years. They will be tested at a baseline visit, then every 6 months for a total of at least 5 visits. During these visits, they will be asked to complete the following: questionnaires about quality of life and depression, tests to measure strength and motor function, tests to measure cognition, an orientation session to learn a precision griping task, structural and functional MRI scans of the brain, measurement of brain waves using a non-invasive technique called electroencephalography (EEG) and muscle activity using electromyography (EMG), measurement of brain function with TMS, pregnancy test (if applicable).
15943067|NCT03318107|Device|Transvaginal probe using photoacoustic and ultrasound imaging|-Four optical wavelengths of 730nm, 780nm, 800 nm, and 830 nm will be used to acquire data
15943068|NCT03318094|Drug|Phentolamine|Intrabrachial phentolamine will be given on the blocked day
15943069|NCT03318094|Other|Saline|Intrabrachial saline will be given this day
15943070|NCT03318094|Drug|Sodium Nitroprusside|Intrabrachial sodium nitroprusside will be given this day to compare with phentolamine
15943071|NCT03318081|Behavioral|cognitive function rehabilitation and bias modification|cognitive rehabilitation focus on the deficits executive funcitin and elevated cognitive bias
15943072|NCT03318068|Other|Yoga Intervention|The yoga intervention will consist of a combination of yoga postures, gentle stretches, breathing techniques and relaxation. The sessions will be delivered one-on-one and will be adapted to accommodate the patients each day.
15943073|NCT03318042|Other|Walnuts|The group consumed a daily serving of walnuts (30 g) or 200 mL pomegranate juice for 3 days and provided a sample of urine as well as a swab specimen from the inner cheek
15943074|NCT03318042|Other|Pomegranate juice|Those volunteers who were allergic to nuts consumed 200 mL pomegranate juice daily for 3 days and provided a sample of urine as well as a swab specimen from the inner cheek
15943075|NCT03318029|Dietary Supplement|Vitamin D supplementation|Vitamin D supplementation of 600 IU daily for 12 weeks
15943076|NCT03318029|Dietary Supplement|Placebo|rice flour with no vitamin D
15943077|NCT03318016|Drug|Cyclophosphamide|"ATO at a fixed dose of 0.15 mg/kg/d IV followed by Cyclophosphamide on day 4 as a single IV dose along with Mesna (in subjects receiving >1000mg/m2 Cy) and hydration for a maximum of 6 doses in the following dose escalation schema:
~Cohort -1 (3-6 subjects, if needed): Cyclophosphamide 500 mg/m2
~Cohort 1 (3-6 subjects): Cyclophosphamide 1000 mg/m2
~Cohort 2 (3-6 subjects): Cyclophosphamide 2000 mg/m2
~Cohort 3 (3-6 subjects): Cyclophosphamide 3000 mg/m2
~Cohort 4 (3 subjects): Cyclophosphamide 4000 mg/m2"
15943078|NCT03318003|Device|Auto-PAP|Women will be using the Auto-PAP device nightly from randomization to end of pregnancy
15943079|NCT03317990|Procedure|NeuroSAFE procedure|When the prostate is removed from within the patient as it is disconnected from its attachments. The specimen will then be painted (right=blue, left =black) by the operating surgeon and delivered expediently to the pathologist who will perform frozen section analysis of the painted areas. The pathologist will remove the pre-painted surface of the gland (which had been in contact with the neurovascular bundles) using a sharp blade. The tissue sample will be snap frozen and embedded in OCT. If a positive margin is reported by the pathologist, the entire neurovascular bundle on the affected side will be removed and sent for formal pathological examination.
15943080|NCT03317990|Procedure|Standard RARP|Patients will undergo the standard intervention - RARP without NeuroSAFE Frozen section analysis
15943081|NCT03317977|Behavioral|Reach for Control|In Phase 1 (weeks 1-4), the CHW conducts an initial intake and then completes a comprehensive functional analysis (FA) of behavior to determine the causes of poor asthma management for each youth regarding asthma management. In Phase 2 (weeks 5-20) is a treatment phase and consists of a combination of mandatory cognitive-behavioral skills training (CBST) modules (received by all families) and flexible CBST modules chosen and individualized based on the results of the Phase 1 FA. This includes but not limited to In-vivo Asthma Skills Training, Improving Family Communication and Behavioral Contracting. Phase 3 (weeks 21-24) involves termination planning and relapse prevention
15943082|NCT03317977|Behavioral|MATCH|Managing Asthma Through Case Management in Home (MATCH) is the current intervention provided by WCHAP to youth with poorly controlled asthma and their families.
15943083|NCT03317964|Other|Saliva sample|Extract sample of saliva only once
15943084|NCT03317951|Other|Novel integrated care concept (NICC)|Integrated care concept including, e.g., call center, guideline therapy, tablet and medical devices
15943085|NCT03317951|Other|Standard care|Guideline therapy according to the guidelines of the European Society of Cardiology (ESC).
15943086|NCT03317938|Device|Fecobionics|Fecobionics is a new device for studying defecation
15943087|NCT03317925|Procedure|Renal Transplantation|Kidney transplantation and biomarkers that can identify injury after transplant.
15943088|NCT03317912|Drug|Lidocaïne 2%|Continuous infusion during per and postoperative periods
15943089|NCT03317912|Drug|Placebo (for Lidocaïne)|Continuous infusion during per and postoperative periods
15943090|NCT03317899|Procedure|Hematopoietic Cell Transplantation|Undergo auto HSCT
15943091|NCT03317899|Drug|Tbo-filgrastim|Given subcutaneously
15943092|NCT03317899|Other|Laboratory Biomarker Analysis|Correlative Studies
15943093|NCT03317886|Procedure|pancreaticoduodenectomy|pancreaticoduodenectomy for pancreatic ductal adenocarcinoma
15943094|NCT03317873|Dietary Supplement|Testmeal A|The tesmeal A is is plain rice, with a seaweed sauce, fortified with labelled iron as stable iron isotope as ferrous sulfate
15943095|NCT03317873|Dietary Supplement|Testmeal B|The tesmeal B is plain rice, with a seaweed sauce, fortified with labelled iron as stable iron isotope as ferrous sulfate
15943096|NCT03317860|Device|Sham tDCS|"Sham tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand. tDCS is a form of noninvasive brain stimulation. Electrodes will be placed on the scalp but in the sham condition they will not deliver direct current (2mA). Sham tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand.
~Repetitive task-specific practice (RTP). Participants will practice using their paretic arm/hand to complete functional movements during the 30 minute train"
15943097|NCT03317860|Device|Active tDCS|"Sham tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand. tDCS is a form of noninvasive brain stimulation. Electrodes will be placed on the scalp but in the sham condition they will not deliver direct current (2mA). Sham tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand.
~Repetitive task-specific practice (RTP). Participants will practice using their paretic arm/hand to complete functional movements during the 30 minute train"
15943098|NCT03317847|Drug|Bromfenac 0.09 % Ophthalmic Solution|Patients will self-administer 1 drop of Bromfenac twice daily to the affected eye beginning 1 day after cataract surgery and then continuing through the first 14 days of the postoperative period.
15943099|NCT03317847|Drug|Dexamethasone 0.1% ophthalmic suspension|Patients will self-administer 1 drop of Dexamethasone to the study eye beginning 1 day after cataract surgery 4 times daily during the first postoperative week and 2 times daily in the second postoperative week.
15943100|NCT03317834|Device|Navio ™ Robotic-assisted Surgical System|Total Knee Replacement
15943101|NCT03317808|Diagnostic Test|Different exercise|Evaluating the difference between Heavy slow resistance and traditional exercise, based on the SPADI score.
15943102|NCT03317795|Drug|Levonorgestrel IUS|LNG-IUS was FDA-approved for the treatment of heavy menstrual bleeding in 2009 and previously for contraception in 2000. The LNG-IUS is a T-shaped device with a polyethylene body containing a hormone reservoir, holding a total of 52 mg of levonorgestrel. LNG-IUS initially releases 20 micrograms of the progestin per day, which decreases to less than half that amount after 5 years of use. The levonorgestrel causes stromal pseudodecidualization, decreases endometrial thickness, and lowers uterine vascular density.
15943103|NCT03317795|Drug|Tranexamic Acid|Tranexamic Acid was FDA-approved for the treatment of heavy menstrual bleeding in 2009. Tranexamic Acid is a plasminogen-activator inhibitor that blocks fibrinolysis and reduces plasmin activity. A special formulation was designed for the treatment of heavy menstrual bleeding that reduces gastrointestinal side effects, brand name Lysteda which will be prescribed as 1300 mg to be taken three times per day for up to 5 days of the menstrual period.
15943104|NCT03317782|Device|NoL index|The NoL/PMD-200 (Medasense Biometrics Ltd, Ramat Yishai, Israel) is a multi-parameter index (0-100) that incorporates heart rate, heart rate variability (0.15-0.4 Hz band power), plethysmograph wave amplitude, skin conductance level, number of skin conductance fluctuations (NSCF), and their time derivatives9 using a non-linear regression technique. A higher index indicates higher nociception, and an index <20 indicates adequate analgesia.
15943105|NCT03317769|Other|Computerized Plasticity-Based Adaptive Cognitive Training|Training on computerized exercises that targets social cognition for 2 hours per week.
15943106|NCT03317769|Other|Commercially available computerized training|Training on computerized, casual video games for 2 hours per week.
15943107|NCT03317769|Other|Optimized social skills training|Group-video calls with Specialist for 1 hour per week where participants can interact with Specialist individually or as a group. Specialist will provide guidance, support and feedback, and send links and articles about information and topics discussed during the video calls.
15943108|NCT03317769|Other|Unstructured support group sessions|Unstructured support group-video calls for 1 hour per week. The Specialist will not engage with participants (eg. providing participants with links to articles and additional support) or provide guidance for the group discussion.
15943109|NCT03317756|Other|Patient Educational Intervention|Patients will view 5-6 videos that will help them with pre-identified patient barriers to achieving RA low disease activity
15943110|NCT03317756|Other|Patient Control|Patients will receive an attention control
15943111|NCT03317743|Drug|NOV140101 (IDX-1197)|The dose levels will be escalated following a 3+3 dose escalation scheme.
15943112|NCT03317730|Drug|Xtampza ER|Xtampza ER is a wax microsphere formulation of oxycodone that results in a nearly identical pharmacokinetic profile regardless of whether the capsule is intact when ingested or if ingested via enteral feeding tube as opposed to by mouth.
15943113|NCT03317717|Drug|Meditoxin|injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses
15943114|NCT03317717|Drug|Botox|injection of MEDITOXIN into EDB muscle of one foot and BOTOX into the same muscle of contralateral foot in equal doses
15943115|NCT03317704|Behavioral|Speed endurance training|Speed endurance training
15943116|NCT03317691|Diagnostic Test|electrocardiogram diagnosed by artificial intelligence|According to coronary angiogram results, the accuracy of STEMI patients' electrocardiogram diagnosis by artificial intelligence was evaluated.
15943117|NCT03317678|Dietary Supplement|BioKefir|BKP BioKefir (Lifeway Foods) is a lactose-free fermented milk product containing 12 different bacteria provided in a drink.
15943118|NCT03317678|Dietary Supplement|Non-fermented milk|A non-fermented milk drink.
15943119|NCT03317665|Device|Mesh for hernia repair|Permacol, Parietex, Progrip, Strattice Perforated, and Surgimend.
15943120|NCT03317652|Other|Hyperventilation|The subject is instructed to hyperventilate for 6 min to provoke a 0.7-1.2 kPa reduction in PaCO2, and the evaluation is repeated if the reduction in PaCO2 is not within this interval. The order of hyperventilation and 6% CO2 breathing is randomized.
15943121|NCT03317652|Other|6% CO2 breathing|The subject breathes a mixture of 6% CO2 (with 21% O2 and 73% N2) from a bag and a face mask for 6 minutes. The order of hyperventilation and 6% CO2 breathing is randomized.
15943122|NCT03317652|Drug|Infusion of sodium nitroprusside|Using incremental intravenous infusion of sodium nitroprusside MAP is reduced by 20% (15%-25%) and then by 40% (35%-45%, MAP minimally at 50 mmHg).
15943123|NCT03317639|Behavioral|Behaviour Change Wheel model guided intervention|Interventions are developed on a psychological model, the Behaviour Change Wheel (BCW) .The fundamental of BCW consists of three essential elements: capability, motivation, and opportunity. Improving individual's capability, providing motivation, and increasing opportunities are goals of behaviour change intervention. To achieve the goals, 9 intervention components have been proposed in the BCW framework, and 6 components will be used in current study.
15943124|NCT03317626|Diagnostic Test|Cold Stimulus (ice) Test|Standard of care epidural will be inserted. The study procedure will be to use a cold stimulus (ice) to assess the subjects for hypesthesia the dermatomes of the lower abdomen at 15 minutes and if necessary at 30 minutes after the epidural is inserted. Hypesthesia to cold will be taken a sign of successful lumbar epidural block.
15943125|NCT03317613|Drug|Qutenza|Patients suffering from neuropathic pain will receive patch of capsaicin (qutenza) on the painful zones. Three months after the first application, patients will be allowed to receive another patch if necessary. They will be able to receive one every three months. They will be followed in the study during one year after the first patch application.
15943126|NCT03317600|Device|Lidocaine|Intervention is a nerve block with Lidocaine 2% with Adrenaline.
15943127|NCT03317600|Drug|Placebo|"Intervention is a placebo nerve block with isotonic saline"
15943128|NCT03317587|Behavioral|INSPIRE|Eight week program of weekly group sessions with homework assignments addressing beauty ideals, establishing a healthy relationship with food and exercise, and tolerating and managing uncomfortable emotions. Participants will complete questionnaires are separate time points (one week before the program, one week after the program, and 1 month after the program) to evaluate the impact of the program on various behavioral and psychological outcomes.
15943129|NCT03317574|Drug|botulinum toxin type A|24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas
15943130|NCT03317574|Drug|botulinum toxin type A|24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas
15943131|NCT03317548|Diagnostic Test|progesterone|according progesterone level to decide fresh or frozen embryo transfer
15943132|NCT03317548|Diagnostic Test|day 3 embryo|according day 3 embryo to decide fresh or frozen embryo transfer
15943133|NCT03317535|Procedure|General anesthesia|Patients will be injected with propofol, remifentanil and muscular relaxant with controlled ventilation.
15943134|NCT03317535|Procedure|Local anesthesia/concious sedation|Patients will be injected with propofol and remifentanil.
15943135|NCT03317535|Procedure|Spontaneous breath|Patients will be kept spontaneous breath.
15943136|NCT03317535|Procedure|Controlled ventilation|Patient will be kept with controlled ventilation.
15943137|NCT03317509|Procedure|repetitive transcranial magnetic (rTMS)|Real rTMS high frequency stimulation (25 HZ), with intensity of 80% of resting motor threshold detected from the hand motor area, with total 2000 pulses for each hemisphere for 10 consecutive sessions totally over period of 10 days. Sham rTMS is the same pulse as the first group but with the coil placed perpendicular to the scalp.
15943138|NCT03317496|Drug|Avelumab 800 mg in combination with pemetrexed / carboplatin|Avelumab Pemetrexed Carboplatin
15943139|NCT03317496|Drug|Avelumab 800 mg in combination with gemcitabine / cisplatin.|Avelumab Gemcitabine Cisplatin
15943140|NCT03317496|Drug|Avelumab 1200 mg in combination with pemetrexed/carboplatin|Avelumab Pemetrexed Carboplatin
15943141|NCT03317496|Drug|Avelumab 1200 mg in combination with gemcitabine/cisplatin|Avelumab Gemcitabine Cisplatin
15943142|NCT03317470|Other|Basic needs survey|-11 questions about food security, housing personal safety, neighborhood safety, childcare, and transportation
15943143|NCT03317470|Behavioral|Life Navigator|"The life navigator will contact women identified with unmet basic needs within two business days of completing the baseline survey.
~The life navigator in our study will: (1) identify and assess women's needs; (2) jointly generate solutions to address the needs; (3) develop plans to carry out the solutions, including; (4) help prioritize among multiple needs; (5) identify community resources that could help solve the problem; (6) determine eligibility for services; (7) help women access available resources by scheduling appointments and provide appointment reminders; (8) prepare women to interact with service agencies and/or act as an advocate on their behalf; (9) provide instrumental support such as arranging transportation; (10) actively intervene to resolve barriers to basic needs solutions; (11) oversee follow-up of problem solving actions; and (12) review progress made towards resolving unmet basic needs and adapt solutions accordingly."
15943144|NCT03317470|Other|Follow-up survey|-5 questions about the acceptability of the basic needs survey
15943145|NCT03317470|Other|Follow-up survey (phase II participants only)|-7 questions about the effectiveness of the life navigator
15943146|NCT03317457|Biological|Durvalumab and Tremelimumab|immun checkpoint inhibitor
15943147|NCT03317457|Drug|Doxorubicin|Anthracycline
15943148|NCT03317444|Drug|TRC101|Oral suspension
15943149|NCT03317444|Drug|Placebo|Oral suspension
15943150|NCT03317431|Other|mechanical ventilation|mechanical ventilation protocol: tidal volume 6-8 ml/kg, positive end-expiratory pressure 5 cmH2O, oxygen concentration 40%; respiratory rate 10-15/min, inspiratory/expiratory ratio 1:1.5.
15943151|NCT03317418|Other|ATR-FTIR Spectrophotometry|Spectrometry imaging
15943152|NCT03317405|Drug|Endoxifen Hydrochloride|Apply to the skin
15943153|NCT03317405|Other|Placebo Administration|Apply to the skin
15943154|NCT03317405|Other|Questionnaire Administration|Ancillary studies
15943158|NCT03317379|Behavioral|Peer mentorship|Weekly meetings with a recovered peer mentor once per week. Dyads discuss eating disorder symptoms and how to overcome them.
15943159|NCT03317379|Behavioral|Social support mentorship|Weekly meetings with a social support mentor who has not personally struggled with an eating disorder, once per week. Dyads engage in activities unrelated to the eating disorder (e.g., a movie, a community event, volunteer work).
15943160|NCT03317379|Behavioral|Recovery Record use with mentor|Recovery Record is a smart phone or web-based application designed to provide recovery support to eating disorder patients. Includes a number of features aimed to promote recovery, such as a meal tracking, prompts for completing meals/snacks, tracking for additional symptoms such as stress and mood, motivational messages, information about coping strategies, and capacity to share logged data with clinicians and mentors.
15943161|NCT03317366|Drug|ARQ 092|Open-label expanded access for ARQ 092 capsules
15943162|NCT03317353|Device|Vestibular rehabil.: CDP|Vestibular rehabilitation, ten sessions
15943163|NCT03317353|Device|Vestibular rehabil.: optokinetic stimuli|Vestibular rehabilitation, ten sessions
15943164|NCT03317353|Other|Vestibular rehabil.: home exercises|Exercises performed twice a day for two weeks. Approximate duration of each session: 15 minutes
15943165|NCT03317340|Other|Background Sounds|Background music or sound of running water
15943166|NCT03317327|Drug|Nivolumab|Nivolumab is a humanized antibody used in cancer immunotherapy.
15943167|NCT03317327|Radiation|Radiotherapy (RT)|Radiotherapy (RT) will be given to a total dose of 60 Gy (1,5 Gy fractions twice daily) for a total period of 4 weeks
15943168|NCT03317314|Diagnostic Test|Lung Biopsy during LVAD Implantation|Lung Biopsy during LVAD Implantation
15943169|NCT03317301|Drug|HL151|2 times a day(Day, Night), 2 weeks of treatment / Day: HL151 (1Tab)+Talion Tab (Placebo)(1Tab), Night: HL151 (Placebo)(1Tab)+Talion Tab (Placebo)(1Tab)
15943170|NCT03317301|Drug|Talion Tab|2 times a day(Day, Night), 2 weeks of treatment / Day: HL151 (Placebo)(1Tab)+Talion Tab (1Tab), Night: HL151 (Placebo)(1Tab)+Talion Tab (1Tab)
15943171|NCT03317288|Device|Dabir Air overlay|The Dabir Air overlay is a low profile alternating pressure overlay that is designed to place on top of mattress and operation room table.
15943172|NCT03317275|Device|18F-Fluoride-PET/MRI|facet joint injection guided by the anatomical localization of causative structures by PET/MRI compared to standard assessment techniques.
15943173|NCT03317275|Procedure|facet injection|facet joint local anesthetic and corticosteroid injection according to the 18F-Fluoride-PET/MRI result or based on current standard clinical practise (MRI and clinical correlation) respectively
15943174|NCT03317275|Other|pain assessment by VAS|VAS questionnaire immediately before the facet joint injection, at 15 minutes, 1 day, 1 week and 1 month after the injection, as performed routinely in our institution.
15943175|NCT03317249|Diagnostic Test|ECG|12-lead electrocardiogram
15943176|NCT03317249|Diagnostic Test|heart rate monitor|24-hour heart rate monitor used to calculate mean heart rate and heart rate variability
15943177|NCT03317249|Diagnostic Test|Autonomic Nervous System (ANS) Activity|"Heart Rate Variability (HRV) and Baroreflex sensitivity (BRS):
~Resting and exercise HRV and BRS calculated from ECG, Dundee Step test and blood pressure measurements."
15943178|NCT03317249|Diagnostic Test|Haemodynamic variables|Cardiac output (CO), stroke volume (SV) and systematic vascular resistance (SVR) will be assessed and calculated using a non-invasive, inert gas re-breathing technique whereby expired gases will be sampled and analysed alongside and blood pressure measurements.
15943179|NCT03317249|Other|Echocardiogram|optional (for non-IST participants only)
15943180|NCT03317236|Drug|Quetiapine|A fixed 50 mg exteded release formulation.
15943182|NCT03317210|Drug|iron sucrose (200 mg VENOFER®)|According to hemoglobin level at the start of the therapy, the women were either treated with intravenous iron and rhEPO or with intravenous iron only twice weekly.
15943183|NCT03317210|Drug|recombinant human erythropoietin (10,000 U EPREX®)|According to hemoglobin level at the start of the therapy, the women were treated with rhEPO twice weekly.
15943184|NCT03317197|Drug|Control Group|Using Epinephrine(1 mg/cardiopulmonary resuscitation(CPR) cycle) only
15943185|NCT03317197|Drug|Experimental Group 1|Using Epinephrine(1 mg/cardiopulmonary resuscitation(CPR) cycle) and Vasopressin(20 international unit(IU)/cardiopulmonary resuscitation(CPR) cycle)
15943186|NCT03317197|Drug|Experimental Group 2|Using Epinephrine(1 mg/cardiopulmonary resuscitation(CPR) cycle) and Steroid(Methylprednisolone, 40 mg at first cycle)
15943187|NCT03317197|Drug|Experimental Group 3|Using Epinephrine(1 mg/cardiopulmonary resuscitation(CPR) cycle), Vasopressin(20 international unit(IU)/cardiopulmonary resuscitation(CPR) cycle) and Steroid(Methylprednisolone, 40 mg at first cycle)
15943188|NCT03317184|Procedure|Periumbilical incision|A periumbilical incision is made at the abdominal midline for hand-assisted laparoscopic donor nephrectomy.
15943189|NCT03317184|Procedure|Pfannenstiel incision|Pfannenstiel incision is made as a slightly curved horizontal line just above the pubic symphysis for hand-assisted laparoscopic donor nephrectomy.
15943190|NCT03317171|Dietary Supplement|Flavonoids, DHA, EPA|oral administration
15943191|NCT03317171|Dietary Supplement|placebo compound|oral administration
15943192|NCT03317158|Drug|Durvalumab|Durvalumab 1120 mg intravenously Day 1 every 21 days x 8 cycles.
15943193|NCT03317158|Radiation|External Beam Radiotherapy (EBRT)|EBRT 6 Gy x 3; Cycle 1 Day 1, 3, and 5
15943194|NCT03317158|Biological|Bacillus Calmette-Guérin (BCG)|"Dose level 0 (starting dose) = Full-dose
~Dose level-1 = 1/3rd-dose BCG. Dose level -1 is expected to be utilized during the phase II portion of the study due to the ongoing and persistent shortage of BCG in the US."
15943195|NCT03317145|Device|Neuromuscular electrostimulation (NMES) device|A mobile peroneal nerve stimulator
15943196|NCT03317145|Device|Intermittent pneumatic compression (IPC) device|A foot pump or foot compression device
15943197|NCT03317132|Behavioral|IPS|One year of IPS Support
15943198|NCT03317119|Other|Laboratory Biomarker Analysis|Correlative studies
15943199|NCT03317119|Drug|Trametinib|Given PO
15943200|NCT03317119|Drug|Trifluridine and Tipiracil Hydrochloride|Given PO
15943201|NCT03317093|Drug|Ceftobiprole Medocaril|1 single intravenous dose of 500 mg of Mabelio (Ceftobiprole Medocaril) perfused for 2 hours at D0
15943202|NCT03317093|Other|Blood samples and cerebrospinal fluid|Before and immediately before the end of the perfusion and then at 0.5h, 1h, 3h, 6h, 12h and 24h.
15943203|NCT03317067|Drug|Dexmedetomidine|The 4D trial is an investigator-initiated, prospective, multicenter, randomized, double-blinded, two-arm trial, randomizing 300 non-intubated ICU patients with diagnosis of agitated delirium to receive dexmedetomidine or placebo as a cure
15943204|NCT03317067|Other|Placebo|The 4D trial is an investigator-initiated, prospective, multicenter, randomized, double-blinded, two-arm trial, randomizing 300 non-intubated ICU patients with diagnosis of agitated delirium to receive dexmedetomidine or placebo as a cure
15943205|NCT03317041|Other|Capacitive-resistive electric transfer (Tecar) therapy|The Tecar treatment group will receive 45 minutes of Tecar therapy treatment. Subjects will lay down with the face down and two metallic plaques situated under each quadriceps muscle all over all the treatment. The treatment will start with the automatic capacitive energy transfer for 10-min where the capacitive plaque is situated on the sole of each foot with an elastic band. After that, the capacitive plaque will be pulled out. Then, the resistive electrode will be moved longitudinally through different muscles with massage lotion during 15-min per each lower extremity. The treatment will conclude with the automatic capacitive energy transfer for 10-min and the capacitive plaque situated on the sole of each foot with an elastic band.
15943206|NCT03317028|Drug|CS02 tablet and placebo tablet|Subjects receive CS02 tablet or placebo tablet BID daily with a stable dose of metformin monotherapy of ≥ 1500 mg/day for 12 weeks treatment.
15943207|NCT03317015|Drug|triamcinolone XRG5029|"Pharmaceutical form: spray solution
~Route of administration: nasal"
15943208|NCT03317015|Drug|fluticasone|"Pharmaceutical form: spray solution
~Route of administration: nasal"
15943209|NCT03317002|Drug|AZD5718|Oral dose of AZD5718 (tablet)
15943210|NCT03317002|Drug|AZD5718|Oral dose of AZD5718 (tablet)
15943211|NCT03317002|Drug|Placebo|Matching placebo (tablet)
15943212|NCT03316976|Drug|Dexlansoprazole|Dexlansoprazole delayed-release capsule.
15943213|NCT03316963|Drug|Neostigmine Methylsulfate|After the patient demonstrates snoring and obstruction collapse, the patient will receive the study medication (neostigmine methylsulfate 1mg/mL) into the soft palate with co-administration of intravenous glycopyrrolate 0.2mg. At each of 5 injection sites on the soft palate , 0.5 mL (0.5mg) of neostigmine methylsulfate will be administered, yielding a total of 2.5mg (2.5mL) of neostigmine methylsulfate. The medication will be administered using five 1 mL syringes filled with 0.5 mL neostigmine each. Following administration of neostigmine, the patient will be observed for an additional 4 minutes to examine both vibration and sound emanating from the soft palate. The anticipated time under sedation will be 14 minutes.
15943309|NCT03316157|Behavioral|Physical Exercise|Patients will receive an individualised exercise regimen consisting of 60 minutes aerobic and 3x resistance elements per week
15943214|NCT03316950|Device|IntraGen RF|IntraGen is a radiofrequency vaginal rejuvenation device FDA approved for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The hand piece is a disposable monopolar applicator that is used to apply energy internally and externally.
15943215|NCT03316950|Device|DiVA|DiVA device utilizes a hybrid fractional laser technology in a wand hand piece. The hand piece is covered by a single use strengthened quartz dilator that allows the hand piece to rotate and provide treatment in a uniform manner.
15943216|NCT03316937|Procedure|Types of scalers|Scaling
15943217|NCT03316924|Procedure|Foreskin resection|During the pediatric surgery consultation, the doctor will decide between Foreskin resection, orchidopexie or inguinal hernia repair.
15943218|NCT03316911|Behavioral|MKit|MKit is a web-based application that uses a life-skills approach to address healthy relationships and sexual violence. It includes 14 tiles which incorporate information, goal setting, and resources.
15943219|NCT03316898|Drug|AGN-242071|AGN-242071 capsules administered once daily to patients receiving donepezil 10 mg with or without memantine as prescribed per standard of care.
15943220|NCT03316898|Drug|Placebo|Placebo capsules once daily to patients receiving donepezil 10 mg with or without memantine as prescribed per standard of care.
15943221|NCT03316898|Drug|Donepezil|Donepezil 10 mg as prescribed by the physician as per standard of care.
15943222|NCT03316898|Drug|Memantine|Memantine as prescribed by the physician as per standard of care.
15943223|NCT03316885|Device|Clareon® IOL|Foldable, single-piece posterior chamber IOL intended for long-term use over the lifetime of the cataract patient. This device is CE-marked (European Conformity) in the countries with participating Investigators.
15943224|NCT03316872|Drug|Pembrolizumab|Pembrolizumab is a humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
15943225|NCT03316872|Radiation|Stereotactic Body Radiotherapy (SBRT)|SBRT involves delivery of high doses of radiation therapy in smaller fractions
15943226|NCT03316859|Drug|Naloxegol 25 MG|Naloxegol 25 mg administered 1 hour pre-operatively
15943227|NCT03316859|Other|Placebo pill|Placebo pill administered 1 hour pre-operatively
15943228|NCT03316846|Behavioral|Internet-Delivered Cognitive Behavioral Therapy|
15943229|NCT03316833|Device|Resolute Onyx|Percutaneous coronary revascularization of patients with unprotected left main coronary artery disease up to intermediate anatomical complexity (defined by a SYNTAX score <33), must be performed with the exclusive use of drug-eluting stents of the Resolute Onyx TM family
15943230|NCT03316820|Drug|K0706|Study treatment with water after an overnight fast
15943231|NCT03316820|Drug|K0706|Study treatment with water after food
15943232|NCT03316807|Biological|60 µg dose hepatitis B vaccine|three-dose, 60 µg per dose
15943233|NCT03316807|Biological|20 µg dose hepatitis B vaccine|three-dose, 20 µg per dose
15943234|NCT03316794|Drug|SC-005|intravenous
15943235|NCT03316781|Drug|HLX03|80 mg SC at Week 0, 40 mg SC at Week 1, and 40 mg every other week thereafter.
15943236|NCT03316781|Drug|adalimumab|80 mg SC at Week 0, 40 mg SC at Week 1, and 40 mg every other week thereafter.
15943237|NCT03316755|Behavioral|Exposure|Exposure to pamphlet
15943238|NCT03316742|Combination Product|Intervention 1|Intervention 1 includes providing participants with a high fiber food product, protein source, high intensity sweetener and adult multivitamin.
15943239|NCT03316742|Combination Product|Intervention 2|Intervention 2 includes providing participants with an alternative dietary fiber source, milk protein, high intensitysweetener and adult multivitamin.
15943240|NCT03316729|Drug|DS-9231|DS-9231 in saline solution for intravenous infusion
15943241|NCT03316729|Drug|Placebo|Placebo is matching saline solution for intravenous infusion
15943242|NCT03316716|Procedure|active warming|Women randomised to the intervention group will be administrated warm IV fluids (39°C) consisting of Hartman's solution with the use of the theatre's Hotline™ device. The Hotline™ device is set to 39°C in which the Hartman's solution bags will be infused to the women peri-operatively.
15943243|NCT03316703|Procedure|Conventional open surgery|"Surgical treatment will be performed by stabilizing the fractured vertebral segment (proximal vertebra and vertebra distal to fractured vertebra and fractured vertebra) by means of a 6.5 mm or 6.5 mm diameter polyaxial pedicle screw system. In the fractured proximal and distal vertebrae to the vertebrae, screws will be used up to the vertebral body and fractured vertebra will use shorter screws that do not penetrate the vertebral body. In the fractured vertebra, single or bilateral pedicle screw will be used according to the degree of involvement of the pedicle of the fractured vertebra.
~The vertebral fixation system will be applied through the conventional open approach (group A)."
15943244|NCT03316703|Procedure|Minimally invasive percutaneous surgery|"Surgical treatment will be performed by stabilizing the fractured vertebral segment (proximal vertebra and vertebra distal to fractured vertebra and fractured vertebra) by means of a 6.5 mm or 6.5 mm diameter polyaxial pedicle screw system. In the fractured proximal and distal vertebrae to the vertebrae, screws will be used up to the vertebral body and fractured vertebra will use shorter screws that do not penetrate the vertebral body. In the fractured vertebra, single or bilateral pedicle screw will be used according to the degree of involvement of the pedicle of the fractured vertebra.
~The vertebral fixation system will be applied through the minimally invasive percutaneous approach (group B) according to allocation after randomization."
15943245|NCT03316690|Drug|Metformin treatment|"Daily treatment with metformin tablets for 101 days according to the following scheme:
~Day 1-4: Metformin tablet 500 mg x 2 Day 5-8: Metformin tablet 1000 + 500 mg Day 9-101: Metformin tablet 1000 mg x 2"
15943246|NCT03316690|Drug|Placebo treatment|"Daily treatment with placebo tablets for 101 days according to the following scheme:
~Day 1-4: Placebo tablet 500 mg x 2 Day 5-8: Placebo tablet 1000 + 500 mg Day 9-101: Placebo tablet 1000 mg x 2"
15943247|NCT03316690|Behavioral|Physical training|Twelve weeks of supervised physical training (4 times per week, 45 min per session, mean intensity at 70% of maximal oxygen consumption rate)
15943310|NCT03316144|Biological|Toripalimab|Dose escalation study evaluating three dose levels (1, 3 and 10 mg/kg) of JS001. Subjects will be assigned to a dose schedule in the order of study entry.
15943421|NCT03315338|Drug|CORT118335, 150mg|CORT118335 is supplied as a suspension for oral dosing
15943422|NCT03315338|Drug|CORT118335, 1500mg|CORT118335 is supplied as a suspension for oral dosing
15943248|NCT03316677|Procedure|Intraoperative testing of colorectal anastomoses|"Insert a Foley catheter through the anus into the rectum.
~Insufflate the Foley balloon with 5 cc of air.
~Air tight leak test with saline and insufflating air: fill the pelvic space with 500 CC of warm saline
~Insufflate air into the rectum up to a pressure of 35 mmH2o as measured by external manometer
~Remove the saline from the pelvic space.
~Inject diluted dye (methylene blue) in to the rectum up to a pressure of 35 mmH2o measured by external manometer
~Remove the methylene blue from rectum.
~NB the above procedures are standard practice for assessing the quality of colorectal anastomoses during colorectal surgery.
~The purpose of the study is to compare these standard methods of evaluation to determinant which method is superior"
15943249|NCT03316677|Procedure|Stapled colorectal anastomoses|After the resection we do the stapled colorectal anastomosis with a standard circular stapler as part of the regular procedure
15943250|NCT03316664|Behavioral|Integrated Neurocognitive Therapy (INT)|Information already included in arm/group description.
15943251|NCT03316664|Behavioral|Integrated Psychological Therapy (IPT)|Information already included in arm/group description.
15943252|NCT03316664|Other|COGPACK|Information already included in arm/group description.
15943253|NCT03316651|Drug|GM-CSF|"After the patients were randomly divided into two groups, they will receive whole lung lavage (WLL), and then one of the two groups with continue the next step as follows:
~Induction period: The time of beginning is 1 week after whole lung lavage, aerosolized GM-CSF was given for 7 days (150ug bid), and then the durg was stopped for 7 days, the 2 weeks was designed as a cycle, a total of 6 cycles (3 months) were known as the induction period.
~Maintenance period: maintenance period came up after the induction period. The dose of aerosolized GM-CSF was reduced to 150ug/d for three times a week, and then the durg was stopped for 7 days, the 2 weeks was designed as a cycle and maintenance period lasted for 9 months."
15943254|NCT03316638|Drug|W0101 - Cohort A1|Administered once every 2 weeks
15943255|NCT03316638|Drug|W0101 - Cohort A2|Administered every 3 weeks
15943256|NCT03316638|Drug|W0101 - Expansion Phase|Administered according to the recommended dose for expansion
15943257|NCT03316625|Diagnostic Test|Bone densitometry measurement|Bone Densitometry and measurement of body composition
15943258|NCT03316612|Dietary Supplement|Vaccinium Myrtillus L. extract|Twice a day, 2 tablets each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.
15943259|NCT03316612|Dietary Supplement|Placebo|Twice a day, 2 tablets each time. Do not take any other medicine, traditional Chinese medicine, or dietary supplements.
15943260|NCT03316599|Drug|Gemcitabine|Gemcitabine is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells.
15943261|NCT03316599|Drug|Nab-paclitaxel|Nab-paclitaxel is a chemotherapy agent. Chemotherapy agents are medicines that kill cancer cells
15943262|NCT03316599|Drug|Ficlatuzumab|It is selective recombinant humanized hepatocyte growth factor (HGF) inhibitory immunoglobulin G subclass 1 monoclonal antibody which blocks the MET tyrosine kinase receptor.
15943263|NCT03316586|Drug|Nivolumab|Nivolumab is an experimental antibody drug that may make the immune response more active against cancer.
15943264|NCT03316586|Drug|Cabozantinib|Cabozantinib may help to shrink or stabilize breast cancer
15943265|NCT03316573|Drug|Pembrolizumab|The study drug is an antibody that targets a molecule called PD-1. Blocking PD-1 allow the immune system to attack the cancer more effectively.
15943266|NCT03316560|Biological|rAAV2tYF-GRK1-RPGR|Adeno-associated virus vector expressing a human RPGR gene
15943267|NCT03316547|Other|SENSE Program|Specific amounts of auditory, tactile, vestibular, kinesthetic, and visual exposure conducted daily through hospitalization. This includes specifically timed and set amounts of reading/talking/singing, cycled lighting, skin-to-skin (kangaroo) care or gentle human touch, rocking, and therapeutic exercises [passive range of motion (PROM), gentle stretching]. The intervention plan is intended to be implemented by parents when available, and by surrogates when the parents are unable to be present in the hospital. Specific amounts and timing of interventions will be tailored to the current medical status and age of each infant.
15943268|NCT03316534|Drug|Aspirin|Aspirin (100 mg once a day)
15943269|NCT03316521|Drug|AMY-101|AMY-101 is a selective inhibitor of complement activation, which binds to the complement component C3.
15943270|NCT03316495|Behavioral|PAMPHLET|EXPOSURE TO PAMPHLETS
15943271|NCT03316482|Drug|Leuplin DPS 11.25mg|Leuplin DPS 11.25mg s.c. every 12 weeks
15943272|NCT03316469|Drug|Clomiphene Citrate|100 mg daily will be provided to the subjects to be taken for 5 days starting from day 2 of their spontaneous periods
15943273|NCT03316469|Diagnostic Test|Follicular growth|Follicular growth assessment by TVU will be performed at day 12 of the menstrual period.
15943274|NCT03316456|Diagnostic Test|Observational: Stool Sample Collection|"Observational: Stool Sample Collection
~- Samples will be collected on the day of the first dose of chemotherapy, then subsequently every Monday, Wednesday, Friday until Day 28 of chemotherapy, death, or discharge from the hospital, whichever occurs sooner."
15943275|NCT03316456|Diagnostic Test|Observational: Blood Sample Collection|"Observational: Blood Sample Collection
~- Samples will be collected on the day of the first dose of chemotherapy, then subsequently every Monday, Wednesday, Friday until Day 28 of chemotherapy, death, or discharge from the hospital, whichever occurs sooner."
15943276|NCT03316456|Diagnostic Test|Observational: Urine Sample Collection|"Observational: Urine Sample Collection
~- Samples will be collected on the day of the first dose of chemotherapy, then subsequently every Monday, Wednesday, Friday until Day 28 of chemotherapy, death, or discharge from the hospital, whichever occurs sooner."
15943277|NCT03316443|Device|Glidescope|"The patient will be intubated by suitable sized tube (in males 8 mm and in females 7.5 mm internal diameter).
~For endotracheal intubation with glidescope, size 3 blade will be used in all of the cases. Glidoscope will be advanced gently in the oral cavity (in the midline) and walked down the tongue. The scope will be further advanced into the vallecula and gentle lifting force will be applied for visualization of the glottis. Endotracheal tube will be loaded on specific rigid stylet with 60 degree bent and will be advanced into the trachea by the same operator.
~Systolic, diastolic, mean arterial blood pressure and heart rate will be recorded at the following time points: T1: before anesthesia, T2: after induction and immediately before intubation, T3: immediate after completion of intubation, T4: after 1 minute of intubation, T5: after 2 minutes of intubation, T6: after 3 minutes of intubation, T7: after 5 minutes of intubation, T8: after 10 minutes of intubation."
15977355|NCT03056885|Other|Conventional One-Lung Ventilation|Vt 10 ml/kg
15943278|NCT03316443|Device|Macintosh|The patient will be intubated by suitable sized tube (in males 8 mm and in females 7.5 mm internal diameter). In Macintosh group we will use a blade size 3 at first. The laryngoscope will be advanced in patient mouth displacing the tongue laterally till the laryngoscope reach the vallecula and then gentle lifting will be applied till visualization of the laryngeal inlet then the tube will be advanced.Systolic, diastolic, mean arterial blood pressure and heart rate will be recorded at the following time points: T1: before anesthesia, T2: after induction and immediately before intubation, T3: immediate after completion of intubation, T4: after 1 minute of intubation, T5: after 2 minutes of intubation, T6: after 3 minutes of intubation, T7: after 5 minutes of intubation, T8: after 10 minutes of intubation.Maximal arterial blood pressure and heart rate changes will be recorded
15943279|NCT03316430|Other|Podocyturia quantification|Podocyturia quantification at first planned prenatal care visit before 16 weeks of gestation
15943280|NCT03316417|Other|Renal Tolerance to Immunotherapy|The main objective is to describe the renal tolerance of these innovative therapies within a population homogeneous of patients.
15943281|NCT03316391|Other|Dosage of urinary podocyturia|Dosage of urinary podocyturia at admission, delivery and post-partum visit
15943282|NCT03316378|Drug|Ropivacaine injection|single dose, subcutaneous injection
15943283|NCT03316365|Other|Rhythmic Auditory Stimulation (RAS)|The experimental group (continuous treatment) trained daily with Rhythmic Auditory Stimulation (RAS) for 24 weeks. The control group (intermittent treatment) trained with RAS for 8 weeks, discontinued training for 8 weeks, and resumed training with RAS for 8 weeks. During treatment subjects walked for 30 minutes in a home-based environment with metronome-click embedded music downloaded to an MP3 player and listened to either free-field or via headphones. For the first 8 weeks subjects had 3 metronome rates available to choose from: 100, 105, and 110% of internal usual cadence. During the second 8 weeks available rates were 105, 110 and 115%; and during the last 8 weeks 110, 115, 120%. The control group started their last training segment at 105, 110, and 115%, but could request a change to the faster rates if comfortable.
15943284|NCT03316352|Procedure|Ultrasound-assisted paramedian technique spinal anesthesia|Ultrasound-assisted paramedian technique will be used. A preprocedural ultrasound scan will be performed, and skin marking for spinal entry site will be done using ultrasound scan. Spinal anesthesia will be done according to skin marking using ultrasound, via paramedian approach.
15943285|NCT03316352|Procedure|Landmark-guided paramedian technique spinal anesthesia|Landmark-guided paramedian technique will be used. Spinal anesthesia will be done using conventional landmark-guided paramedian technique.
15943286|NCT03316352|Device|Ultrasound|A preprocedural ultrasound scan will be done using Portable Echocardiography system (Vivid-i, GE healthcare) with 4C-RS convex probe (2.0-5.5 MHz Frequency range).
15943287|NCT03316352|Drug|0.5% heavy bupivacaine|During spinal anesthesia, 0.5% heavy bupivacaine will be administered into intrathecal space. The dose of local anesthetic injected for spinal anesthesia will be at the discretion of the attending anesthesiologist. The dose range of intrathecal bupivacaine will be between 12 and 16 mg.
15943288|NCT03316339|Drug|Dexmedetomidine|Opioid-free anesthesia
15943289|NCT03316339|Drug|Remifentanil|Opioid anesthesia
15943290|NCT03316326|Drug|Tegafur-gimeracil-oteracil potassium|40 mg bid, D1-14
15943291|NCT03316326|Drug|Oxaliplatin|85 mg/m2, D1
15943292|NCT03316326|Drug|Irinotecan|150 mg/m2, D8
15943293|NCT03316313|Diagnostic Test|Hepatitis C Antibody|Patients who received a blood test to screen for the Hepatitis C virus.
15943294|NCT03316300|Combination Product|NT-501|Surgery to receive one NT-501 device implant.
15943295|NCT03316300|Procedure|Sham|Non-penetrating sham procedure to mimic implant procedure.
15943296|NCT03316287|Device|Hearing aid|Smart hearing aid to allow collection of real time hearing aid usage data
15943297|NCT03316287|Device|Mobile phone|Mobile phone linked with the hearing aids to allow users to change the device settings and perform additional listening tests
15943298|NCT03316287|Device|Sensor|Wearable biosensor for the collection of physiological data
15943299|NCT03316274|Drug|Intra-lesional injection of nivolumab|10mg in 1 mL injection into a KS lesion in the skin, every 2 weeks
15943300|NCT03316248|Other|visual feedback|in the study group, subjects were applied for example prosthetic weight bearing exercises in front of the mirror. They watched their reflected image while doing exercises.
15943301|NCT03316248|Other|usual prosthetic rehabilitation|prosthetic weight bearing and balance exercises were applied to the control group for 9 sessions.
15943302|NCT03316222|Drug|GNS561|Escalating doses to be administered 3 times a week.
15943303|NCT03316196|Behavioral|COGENT COGNITIVE TRAINING|Computer-administered cognitive training program. COGENT is a modified working memory capacity task designed to train cognitive functioning. COGENT was designed to contain high interference across trials. By requiring repeated practice with utilization of interference control across trials, COGENT is thought to enhance plasticity of cognitive systems and improve performance. That is, training is based on the premise that learning-based neural changes will occur via repeated exposure to a task demanding cognitive control resources
15943304|NCT03316196|Behavioral|Non training computer condition|The non-training condition requires participants to complete a similar computer task for the same length of time. The non-training is a modified working memory capacity task designed to be inert. The non-training condition was designed to contain relatively less interference demands across trials. Participants are required to remember the same total number of items as in COGENT (i.e., storage requirements were equivalent), but the task contains relatively less interference inherent in the task.
15943305|NCT03316183|Other|Perioperative and postoperative management|Cerebral oximetry informed perioperative management
15943306|NCT03316170|Behavioral|Social Support|A brief phone consultation (10-15 minutes via phone) about free or low-cost resources that may help them address unmet social support needs, and a written directory of a range of social support resources delivered via mail.
15943307|NCT03316170|Drug|NRT Sampling|"A brief phone consult (10-15 minutes via phone) germane to smoking cessation akin to brief advice, a written summary of the benefits of smoking cessation, evidence-based approaches to quit, and the basics of nicotine replacement therapy (NRT) delivered via mail, and a free, 2-week supply of nicotine patches and lozenges delivered via mail."
15943308|NCT03316157|Dietary Supplement|ProSure|Patients will take 2x 220mL nutritional supplements per day for 8 weeks and be given dietary advice to optimise their nutrition
15943311|NCT03316131|Drug|Verinurad|Randomized patients will receive orally once daily fixed dose of verinurad in 2 treatment sequences AB or BA for 7 consecutive days. Treatment A: verinurad + febuxostat + dapagliflozin; Treatment B: verinurad + febuxostat + placebo
15943312|NCT03316131|Drug|Febuxostat|Randomized patients will receive orally once daily fixed dose of febuxostat in 2 treatment sequences AB or BA for 7 consecutive days. Treatment A: verinurad + febuxostat + dapagliflozin; Treatment B: verinurad + febuxostat + placebo
15943313|NCT03316131|Drug|Dapagliflozin|Randomized patients will receive orally once daily fixed dose of dapagliflozin in 2 treatment sequences AB or BA for 7 consecutive days. Treatment A: verinurad + febuxostat + dapagliflozin; Treatment B: verinurad + febuxostat + placebo
15943314|NCT03316131|Other|Dapagliflozin matched placebo|Randomized patients will receive orally once daily fixed dose of dapagliflozin matched placebo in 2 treatment sequences AB or BA for 7 consecutive days. Treatment A: verinurad + febuxostat + dapagliflozin; Treatment B: verinurad + febuxostat + placebo
15943315|NCT03316118|Drug|bupivacaine|Group 1 will receive genicular nerve block using bupivacaine
15943316|NCT03316118|Drug|saline|Group 2 will receive genicular nerve block using normal saline
15943317|NCT03316105|Device|Elira Investigational TENS device|TENS unit placed on skin will deliver electric stimulation to abdominal area.
15943318|NCT03316092|Diagnostic Test|optical coherence tomography|screening and monitoring all patients who are to use or have been using oral Hydroxychloroquine
15943319|NCT03316079|Other|Chest physiotherapy techniques|Respiratory manual CPT
15943320|NCT03316079|Device|Mechanical insufflation-exsufflation|CPT + MI-E (4 series of 5 inspiratory-expiratory cycles at +/- 40 cmH2O, 3 seconds of inspiratory time, 2 seconds of expiratory time and 1 second pause between cycles).
15943321|NCT03316066|Procedure|stellate ganglion block with ropivacaine 0.2% 5 mL|Each patient will undergo two stellate ganglion blocks and receive both volumes of local anesthetics in random order. The stellate ganglion blocks will be separated by 3 weeks in order to assure that no residual effects from the previous block will influence the results.
15943322|NCT03316066|Procedure|stellate ganglion block wit ropivacaine 0.2% 2 mL|Each patient will undergo two stellate ganglion blocks and receive both volumes of local anesthetics in random order. The stellate ganglion blocks will be separated by 3 weeks in order to assure that no residual effects from the previous block will influence the results.
15943323|NCT03316053|Other|Tissue sample for genetic testing|Tissue sample to be obtained during routine endoscopy
15943324|NCT03316040|Behavioral|JIC|"The Join In Circuit on HIV, love and sexuality is a mobile learning system on the core topics of reproductive health and HIV and AIDS, targeting young people. JIC works with person-to-person communication in order to give an opportunity for discussion and for providing information in an open, engaging atmosphere. The JIC uses interactive exercises, pictorial aids and edutainment strategies to promote behavior change among young people aged 15 years and older."
15943325|NCT03316014|Other|Adverse drug reaction|description of the adverse drug reactions (ADR) and the drugs involved in pediatrics
15943326|NCT03316001|Other|Review of multidetector row computed tomography scans|multidetector row computed tomography scans
15943327|NCT03315988|Other|Adoption of a vegan diet|Adoption of a vegan diet The participants of this study wil be asked to adopt a vegan diet under the supervision of a Registered Dietitian.
15943328|NCT03315975|Biological|Inactivated influenza vaccine|One dose of quadrivalent inactivated influenza vaccine
15943329|NCT03315962|Behavioral|SPIRIT Intervention|The intervention will include implementing a teaching collaborative among group of DHOs and TB Supervisors, enabling text messaging between DHOs and front line providers, and establishing a report collaborative where DHOs will receive feedback on the performance of their district in administering IPT compared to other districts.
15943330|NCT03315949|Drug|Polyethylene Glycol (PEG)|Different method for bowel cleansing using same bowel cleanser. Same-day dose group : 4L PEG will be ingested on the day of colonoscopy Spli-dose group : 2L PEG will be ingested 1 day before colonoscopy, remaining 2L PEG will be ingested on the day of colonoscopy
15943331|NCT03315936|Drug|BI 894416|Oral solution
15943332|NCT03315936|Drug|Placebo|Oral solution
15943333|NCT03315936|Drug|BI 894416 (treatment X and Z)|Tablet
15943334|NCT03315936|Drug|BI 894416 (treatment Y)|Oral solution
15943335|NCT03315923|Drug|Rituximab|Patients will receive 1 g of rituximab (two vials of Zytux 500 mg/50 ml) in 500 cc normal saline serum through intravenous infusion as one treatment cycle. This cycle will be repeated every 6 months. Along with rituximab, patients will receive 100 mg of methylprednisolone, 10 mg of chlorpheniramine, and 500 mg of acetaminophen. Before each cycle, patients will be evaluated regarding complete blood count (CBC)-diff, blood urea nitrogen (BUN), Cr, and liver function tests.
15943336|NCT03315923|Drug|Glatiramer Acetate|Patients will receive 40 mg of glatiramer acetate three times per week through subcutaneous injection. Patients will undergo electrocardiography before starting the treatment to find any abnormal finding. Also, lab tests will be checked for them prior to the treatment, including CBC-diff, BUN, Cr, and liver function tests.
15943342|NCT03315897|Drug|Erythropoietin|40.000 IU/ml Erythropoietin (Epoetin alpha; Eprex) diluted with 100 ml saline (0.9% NaCl) is administered 12 times as intravenous infusions over 15 minutes.
15943343|NCT03315897|Drug|Saline|1 ml NaCl is administered 4 times as intravenous infusions over 15 minutes
15943377|NCT03315598|Procedure|Electroacupuncture|lectroacupuncture is a form of acupuncture where a small electric current is passed between pairs of acupuncture needles. According to some acupuncturists, this practice augments the use of regular acupuncture, can restore health and well-being, and is particularly good for treating pain.
15943378|NCT03315585|Device|steep pulse device|Applying the steep pulse to treat the patients with Prostate cancer
15943423|NCT03315338|Drug|Placebo oral capsule|Placebo capsules, orally administered
15943424|NCT03315338|Drug|CORT118335, dose to be determined|CORT118335 is supplied as suspension for oral dosing
15943344|NCT03315884|Procedure|Iliac segment recanalization and stenting Iliac segment Common Femoral Artery (CFA)|"Retrograde femoral access. Brachial access. Standard endovascular access is performed under local anesthesia and affected arterial segment is visualized. Stenosis or artery occlusion is passed with hydrophilic guide. In case of occlusion transluminal or subintimal (often mixed) artery recanalization is performed. To maximize the preservation of the affected artery initial patency, occlusion recanalization is performed by ante-and retrograde accesses. Then stenosis or occlusion predilation is performed with balloon catheter (balloon catheter diameter is smaller than the affected artery diameter for 1-2 mm). After control angiography stent is installed in the aorta-iliac area throughout the lesion (lesion diameter corresponds to the stenotic arteries diameter). In aorta-iliac zone balloon-expandable and self-expandable stents are used."
15943345|NCT03315884|Procedure|Iliac segment recanalization, stenting and plastic Common Femoral Artery (CFA) patch|Standard access to the CFA is performed. Outflow ways and CFA capability for reconstruction are determined. The puncture of the general CFA (retrograde) is performed and the introducer 7Fr. is set. Recanalization of iliac artery occlusion. It is necessary to cross the iliac occlusion in a retrograde fashion first and secure aortic inflow before making the arteriotomy. An ipsilateral, a contralateral and a brachial approaches are used depending on the clinical situation. If the retrograde access to the aorta failed, you use the antegrade crossing of the iliac occlusion with no intention to reenter the lumen in the CFA. After the recanalization and balloon angioplasty of iliac artery we completed the procedure with endarterectomy of CFA, patch closure and iliac stenting. The preference is to perform endarterectomy and patch before iliac stenting because it can be difficult to access the true lumen in a difficult CFA lesion. Controlling angiography were performed. Closing approach.
15943346|NCT03315871|Biological|PROSTVAC-V|Recombinant vaccinia virus vector vaccine of the genus Orthopoxvirus. Administered by subcutaneous injection.
15943347|NCT03315871|Biological|PROSTVAC-F|Recombinant fowlpox virus vector vaccine of the genus Avipoxvirus. Administered by subcutaneous injection.
15943348|NCT03315871|Drug|MSB0011359C (M7824)|Fully human bi-functional fusion protein that combines IgG1 anti-PD-L1 and TGFbetaRII as a monoclonal antibody. Administered via IV infusion over 1 hour.
15943349|NCT03315871|Biological|CV301|Recombinant vaccinia virus vaccine of the genus Avipoxvirus. Administered subcutaneously.
15943350|NCT03315845|Other|Palpation of bony landmarks for neuraxial anaesthesia.|"Manual palpation of anterior and posterior iliac crests; lumbar spinous processes; scapulae; and sacral cornua.
~Ultrasound of neuraxial anatomy to assess depth to epidural space."
15943351|NCT03315832|Drug|Valsartan|The active treatment is valsartan, an orally active, potent, and specific angiotensin II receptor antagonist. The treatment will be initiated (80 mg, daily) at 5±4 days following aortic valve intervention. The dose will be increased at 160 mg daily 13±2 days after aortic valve intervention and, if well tolerated, for the remaining period of the study.
15943352|NCT03315832|Drug|Placebo Oral Tablet|The comparative treatment will be a placebo; tablets of valsartan and placebo have a similar appearance and administration mode. Patient in the control group will receive a placebo using the same protocol as the valsartan group.
15943353|NCT03315819|Procedure|Bankart repair|Arthroscopic repair of anterior capsulo-labral lesions using the Bankart technique.
15943354|NCT03315819|Procedure|Immobilization interne rotation|Immobilisation in rotation Internal (Dujarrier) 3 weeks then rehabilitation
15943355|NCT03315806|Other|Beetroot juice|140 mL of beetroot juice cointaning approximately 9 mmol of nitrate
15943356|NCT03315806|Other|Placebo|140 mL of beetroot juice isent of nitrate
15943357|NCT03315793|Drug|Duloxetine Hydrochloride|Administered orally
15943358|NCT03315793|Drug|Placebo|Administered orally
15943359|NCT03315780|Drug|Dulaglutide|Administered SC
15943360|NCT03315780|Drug|Placebo|Administered SC
15943361|NCT03315767|Diagnostic Test|ARFI-elastography and portal vein flow measurement|Liver and spleen-elastography assessed by ARFI-technique and the portal vein flow value-assessment by ultrasound investigation.
15943362|NCT03315767|Diagnostic Test|HVPG-measurement|Evaluation of Portal Hypertension by HVPG-measurement
15943363|NCT03315754|Drug|TOOKAD Soluble 4 mg/kg|Vascular targeted photodynamic therapy using TOOKAD Soluble
15943364|NCT03315741|Drug|Pirfenidone 267 MG [Esbriet]|Tolerability of drug
15943365|NCT03315728|Other|Quality Improvement Strategy|Quality improvement strategy The 18 month Quality Improvement Strategy includes 3 months preparation, 12 months intervention, 3 months local knowledge translation. The intervention includes Readiness Consultations to assist in understanding available resources to address and adopt diabetes and chronic disease prevention and care strategies. Community teams receive a series of 3 workshops (in-person/virtual) followed by action periods where the team carry out and evaluate PDSAs they develop to improve diabetes care. Coaching is provided by Western during the 3-4 month action periods. FNDSS is a webbased secure community portal system for communities to develop a diabetes registry/surveillance system and generate reports and plan QI initiatives.
15943366|NCT03315702|Other|mechanical ventilation|mechanical ventilation protocol: tidal volume 6-8 ml/kg, positive end-expiratory pressure 5 cm H2O, oxygen concentration 40%; respiratory rate 10-15/min, inspiratory/expiratory ratio 1:1.5.
15943367|NCT03315689|Drug|Vehicle|Vehicle Topical Solution
15943368|NCT03315689|Drug|ATI-50002|ATI-50002 Topical Solution
15943369|NCT03315676|Drug|Oral Bonoprazan|To examine the efficacy of oral Bonoprazan in patients with NSAIDs-induced Erosions and/or Ulcers
15943370|NCT03315676|Drug|Oral Esomeprazol|To examine the efficacy of oral Esomeprazol in patients with NSAIDs-induced Erosions and/or Ulcers
15943371|NCT03315663|Other|Sweetch App & DBWS|Usual care for prediabetes management, Sweetch app, weight monitoring via digital body weight scale (DBWS).
15943372|NCT03315663|Other|Sweetch App Alone|Usual care for prediabetes management, Sweetch app alone.
15943373|NCT03315637|Procedure|Fetoscopic repair of spina bifida|Fetoscopic intrauterine repair of open spina bifida
15943374|NCT03315624|Device|Dialyzer|Three hemodiafiltration sessions assigned to one type of dialyzer FX Coral 600, FX 600 and FX CorDiax 600
15943375|NCT03315611|Drug|'Eucerin AtopiControl Lotion' (for the body)|Treatment with Eucerin AtopiControl Lotion
15943376|NCT03315611|Other|Allergen challenge chamber|Exposure to Dactylis glomerata pollen in an environmental challenge chamber
15943420|NCT03315338|Drug|CORT118335, 900mg|CORT118335 is supplied as a suspension for oral dosing
15943379|NCT03315572|Other|Interviewer administered version of ease of use items|The adult ease of use items will be modified to incorporate language appropriate for pediatric subjects. The interview will be administered by trained clinic-staff for subjects aged 5 to 7 years and those aged 8 to 11 years having difficulty in reading.
15943380|NCT03315572|Other|Self-administered version of ease of use items|The interview will be self-administered by subjects aged 8 to 11 years.
15943381|NCT03315572|Other|Caregiver version of ease of use items|Caregivers will be asked questions regarding their observations and experiences while their child was using ELLIPTA inhaler.
15943382|NCT03315559|Drug|[14C]-GSK2269557 IV infusion|The [14C]-GSK2269557 solution will be available in dosing strength of 10 µg, administered as single dose IV infusion over 15 minutes. It will be prepared by dissolving a hemisuccinate salt (GSK2269557T) in normal saline.
15943383|NCT03315559|Drug|GSK2269557 via DPI|GSK2269557 DPI will be available with dosing strength of 1000 µg, administered as oral inhalation intended to inhale twice. It will be prepared by blending GSK2269557 hemisuccinate salt (GSK2269557H) with lactose and magnesium stearate.
15943384|NCT03315559|Drug|[14C]-GSK2269557 oral solution|The [14C]-GSK2269557 solution will be available with dosing strength of 800 µg, administered as single dose orally. It will be prepared by dissolving [14C]-GSK2269557 hemisuccinate salt (GSK2269557T) in water.
15943385|NCT03315546|Radiation|radiotherapy delivery in deep-inspiration|Radiotherapy delivery i deep-inspiration versus free-breathing
15943386|NCT03315533|Drug|Duloxetine 30 milligrams (MG)|Once a patient's history and screening results have been cleared by a physician investigator, the participant will be randomized by the study site investigational drug services (IDS) to receive duloxetine (30mg or 60mg) vs. placebo
15943387|NCT03315533|Drug|Duloxetine 60 milligrams (MG)|Once a patient's history and screening results have been cleared by a physician investigator, the participant will be randomized by the study site investigational drug services (IDS) to receive duloxetine (30mg or 60mg) vs. placebo
15943388|NCT03315533|Drug|Placebo Oral Tablet|Once a patient's history and screening results have been cleared by a physician investigator, the participant will be randomized by the study site investigational drug services (IDS) to receive duloxetine (30mg or 60mg) vs. placebo
15943389|NCT03315520|Drug|Bendamustine|"BeEAC conditioning regimen:
~bendamustine 200 mg/м2 D-6 - D-5; cytarabine 400 mg/м2 D-4 - D-1; etoposide 400 mg/м2 D-4 - D-1; cyclophosphamide 140 mg/м2 totally, divided in 4 days (D-4 - D-1)"
15943390|NCT03315507|Drug|PB1046 Subcutaneous Injection|Eight weekly doses of PB1046.
15943391|NCT03315494|Drug|SKI-O-703 capsule|SKI-O-703 200 mg capsule with no inactive excipients.
15943392|NCT03315494|Drug|Placebo capsule|Placebo 180 mg capsule filled with microcrystalline cellulose.
15943393|NCT03315481|Procedure|SAX catheter insertion|Suture-method catheter inserted in the short axis of the adductor canal
15943394|NCT03315481|Procedure|LAX catheter insertion|Suture-method catheter inserted in the long axis of the adductor canal
15943395|NCT03315455|Drug|Emicizumab|Emicizumab will be administered via subcutaneous (SC) injection, as described for each treatment arm.
15943396|NCT03315442|Other|Caffeine versus Energy Drink|Caffeine group consumed 200mg of caffeine one time, while the energy drink group consumed 1 16 ounces of energy drink.
15943397|NCT03315429|Diagnostic Test|stress echocardiography|stress testing of patients with functional mitral regurgitation
15943398|NCT03315416|Other|Speech Sound Assessment|Formal standardised speech sound assessment typically used as part of standard NHS care by Speech and language Therapists
15943399|NCT03315403|Diagnostic Test|LytA targeted quantitative polymerase chain reaction (qPCR)|LytA qPCR and cultures will be performed on samples of the upper respiratory tract (nasopahrynx, oropharynx, saliva, sputum if available)
15943400|NCT03315390|Other|"Narrative Exposure Therapy-oriented intervention"|Narrative Exposure Therapy (NET) in an Primary-care adapted Version in 3 sessions (S) 6 weeks (S1), 8 weeks (S2) and 12 weeks (S3) after baseline data collection at T0.
15943401|NCT03315390|Other|improved treatment as usual (iTAU)|improved standard primary care for PTSD according to Guidelines, customized to patients' needs and symptoms during 3 consultations between T0 and T1
15943402|NCT03315377|Procedure|Lunate-Capitate Fusion (LCF)|Operation with lunate-capitate-fusion (LCF)
15943403|NCT03315377|Procedure|Four Corner Fusion (4CF)|Operation with four-corner-fusion (4CF)
15943404|NCT03315364|Drug|Oral paclitaxel|Oral administration on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent
15943405|NCT03315364|Drug|Paclitaxel injection|Premedication, intravenous infusion on D1, D8 and D15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent
15943406|NCT03315351|Procedure|Brachytherapy|"Before it starts, a consultation will be done to collect patient's informations and disease history, a clinical exam will be done and an evaluation of radio-chemotherapy toxicity will be realized.
~The brachytherapy include a pulsating flow treatment driven by RMI and CT-scan"
15943407|NCT03315351|Other|PET-scan|"The patient will undergo 2 PET-scan during the clinical trial:
~the first one is additional to the brachytherapy
~the second one is realized 4 months after the brachytherapy"
15943408|NCT03315338|Drug|CORT118335, 25 mg|CORT118335 is supplied as capsules for oral dosing
15943409|NCT03315338|Drug|Prednisone Oral Tablet|"Challenge Agent, Dose and Route of Administration:
~Standard release 1x20mg and 1x5mg (25mg total) dose, orally administered."
15943410|NCT03315338|Drug|Glucose|75 g in 300 mL solution, orally administered
15943411|NCT03315338|Drug|Placebo oral suspension|"Reference Therapy, Dose and Route of Administration:
~Placebo suspension, orally administered."
15943412|NCT03315338|Drug|CORT118335, 75mg|CORT118335 is supplied as capsules for oral dosing
15943413|NCT03315338|Drug|CORT118335, 225mg|CORT118335 is supplied as capsules for oral dosing
15943414|NCT03315338|Drug|CORT118335, 675mg|CORT118335 is supplied as capsules for oral dosing
15943415|NCT03315338|Drug|CORT118335, 600mg|CORT118335 is supplied as capsules for oral dosing
15943416|NCT03315338|Drug|CORT118335, 630mg|CORT118335 is supplied as capsules for oral dosing
15943417|NCT03315338|Drug|CORT118335, 375mg|CORT118335 is supplied as capsules for oral dosing
15943418|NCT03315338|Drug|CORT118335, 100mg|CORT118335 is supplied as a suspension for oral dosing
15943419|NCT03315338|Drug|CORT118335, 300mg|CORT118335 is supplied as a suspension for oral dosing
15943425|NCT03315325|Biological|Human kisspeptin-10 (metastin 45-54)|Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany) is a potent HPG-axis stimulator and control reproduction.
15943426|NCT03315312|Drug|Fluoride Varnishes|Fluoride varnish is randomly applied on randomly selected first permanent molar. This study uses a natural clinical setting, where clinicians use methods and procedures that are routinely applied in public dental clinics.
15943427|NCT03315312|Drug|Fissure Sealants|Resin-based fissure sealant is applied on contra-lateral first permanent molar and each child serves as its own control. This study uses a natural clinical setting, where clinicians use methods and procedures that are routinely applied in public dental clinics.
15943428|NCT03315299|Drug|ASP2215|Subject will take ASP2215 by mouth daily for 28 day cycles
15943429|NCT03315286|Device|SHADE Ultraviolet Sensor|Patients will wear device for 6 months in addition to their own method of photo-protection.
15943430|NCT03315286|Behavioral|Standard of care counseling|Patients will use their own method of photo-protection
15943431|NCT03315273|Other|Test battery to measure the motor imagery ability|Participants will perform 3 different tests to measure the motor imagery ability
15943432|NCT03315260|Drug|Radium-223 dichloride (Xofigo, BAY88-8223)|Ra-223 is a radiopharmaceutical with an indication to treat Castration Resistant Prostate Cancer (approved indication in Japan)
15943433|NCT03315247|Behavioral|Telephone-Based CBT|The Tele-CBT sessions focus on introducing the cognitive behavioural model of overeating and obesity, scheduling healthy meals and snacks at regular time intervals and recording consumption using food records, scheduling pleasurable alternative activities to overeating, identifying and planning for difficult eating scenarios, and reducing vulnerability to overeating by solving problems and challenging negative thoughts. Participants are expected to complete CBT homework between sessions, such as completing food records, engaging in pleasurable and self-care activities, and completing a variety of worksheets.
15943434|NCT03315234|Genetic|SNPs associated with CAD|Genotyping will be carried out by Real-Time PCR
15943435|NCT03315221|Other|Test product|HMF with added lipids - Intervention group
15943436|NCT03315221|Other|Control product|Commercially available HMF (without lipids) - control group
15943437|NCT03315208|Behavioral|Unified Protocol (UP)|The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) is an evidence-based psychological intervention designed to be applied across anxiety, depressive, and other disorders in which emotion dysregulation is central. The UP targets shared temperamental vulnerabilities to emotional disorders through emotion-focused CBT strategies.
15943438|NCT03315208|Other|Treatment as Usual (TAU)|Treatment as Usual consists of some combination of group therapy, individual therapy, and/or psychopharmacology appointments at an existing comprehensive outpatient program for adolescents and young adults with substance use disorders.
15943439|NCT03315195|Dietary Supplement|Oral nutritional supplement (ONS)|ONS supplement by 500 kcal/day for 14 days
15943440|NCT03315182|Biological|rAAV9.CMV.hNAGLU|Adeno-associated virus serotype 9 carrying the human NAGLU gene under the control of a CMV enhancer/promoter (rAAV9.CMV.hNAGLU) will be delivered one-time through a venous catheter inserted into a peripheral limb vein.
15943441|NCT03315169|Other|External dressing|Application of external dressing whilst perianal abscess cavity heals.
15943442|NCT03315169|Other|Packing of perianal abscess cavity|Internal packing of perianal abscess cavity - standard treatment.
15943443|NCT03315156|Diagnostic Test|Electrogustometery|Taste assessment using EGM
15943444|NCT03315143|Drug|Sotagliflozin (SAR439954)|"Pharmaceutical form: tablet
~Route of administration: oral"
15943445|NCT03315143|Drug|Placebo|"Pharmaceutical form: tablet
~Route of administration: oral"
15943446|NCT03315130|Drug|zilucoplan (RA101495)|Daily subcutaneous (SC) injection
15943447|NCT03315130|Drug|Placebo|Daily subcutaneous (SC) injection
15943448|NCT03315104|Biological|FLU-IGIV|Single dose, sterile liquid formulation for IV administration.
15943449|NCT03315104|Other|Placebo for FLU-IGIV|Single dose, normal saline solution for IV administration.
15943450|NCT03315091|Drug|Treatment A - AZD1775 administered under fasted conditions|Premedication with Kytril (granisetron) 1 mg intravenously or Zofran (ondansetron) 8 mg intravenously within 30 to 40 minutes prior to administration of the AZD1775 capsules. Single dose 300 mg AZD1775, (3 x 100 mg, printed capsules) administered orally under fasted conditions. The drug class of AZD1775 is Wee-1 kinase inhibitor.
15943451|NCT03315091|Drug|Treatment B - AZD1775 administered under fed conditions.|"Premedication with Kytril (granisetron) 1 mg intravenously or Zofran (ondansetron) 8 mg intravenously within 30 to 40 minutes prior to administration of the AZD1775 capsules.
~Single dose 300 mg AZD1775, (3 x 100 mg, printed capsules) administered orally under fed conditions.
~The drug class of AZD1775 is Wee-1 kinase inhibitor."
15943452|NCT03315078|Biological|CD34+ HSCs transduced with the lentivirus vector, VSV-G pseudotyped CL20-4i-EF1α-hγc-OPT|Administered by intravenous (IV) infusion
15943453|NCT03315078|Drug|Palifermin|Administered by IV infusion at a dose of 60 mg/kg/day
15943454|NCT03315078|Drug|Busulfan|Administered by IV infusion at a dose of approximately 3 mg/kg per day
15943455|NCT03315065|Drug|Perfluorinated Gas/Oxygen Mixture|19-Fluorine (19F) MRI of the lungs with 21%/79% Oxygen/Perfluorinated Gas, ≤ 25 liters, gas and Mixture of 30% perfluoropropane and 70% oxygen to measure perfusion single visit, < 1 hour
15943456|NCT03315052|Drug|Budesonide|Oral steroid with high first-pass metabolism in liver
15943457|NCT03315052|Drug|Tacrolimus（FK506）|Calcineurin immunosuppressant
15943458|NCT03315052|Drug|Mycophenolate Mofetil|Immunosupressant
15943459|NCT03315052|Drug|Prednisone|Immunosuppresant
15943460|NCT03315039|Drug|Liposomal Annamycin|2-hour intravenous infusion liposomal annamycin daily for 3 consecutive days followed by 18 days off study drug (i.e., one treatment cycle = 21 days).
15943461|NCT03315026|Drug|Siltuximab|Siltuximab at 11mg/kg will be administered as a 1-hour infusion on day -7 and day +21 (+/-2) after stem cell infusion.
15943462|NCT03315026|Behavioral|The M.D. Anderson Symptom Inventory (MDASI)|assessments will be conducted at baseline (day -10 +/-3), day -2 (+/-1), , day +7 (+/-1 ), and day 30 (+/-3).
15943463|NCT03315013|Procedure|SLATE II|The SLATE II algorithm is a series of questions and procedures that allow a study clinician to determine if antiretroviral therapy for HIV can be started immediately (same-day) or if additional care or services are needed before ART initiation.
15943464|NCT03315000|Drug|Vilanterol and Fluticasone Furoate|Same as vilanterol arm description
15943465|NCT03315000|Drug|Fluticasone Furoate|Same as fluticasone arm description
15943466|NCT03315000|Drug|Placebos|Same as placebo arm description
15943467|NCT03314987|Dietary Supplement|L-carnosine|a naturally occurring di-peptide
15943468|NCT03314987|Other|placebo|an identically appearing supplement
15943469|NCT03314974|Biological|HSCT with TBI Regimen|Day -5 to -2: Total Body Irradiation Day 0: Hematopoietic Stem Cell Transplantation Day +3 to +4: Cyclophosphamide Day +5: Tacrolimus from day +5 until taper day +100 (day +60 for peds if no acute or chronic GVHD present) Day +5: Mycophenolate mofetil through day +35 or 7 days after engraftment, whichever day is later, if no acute GVHD
15943470|NCT03314974|Biological|HSCT with Non-TBI Regimen|Day -5 to Day -2: Busulfan and Fludaribine Day 0: Hematopoietic Stem Cell Transplantation Day +3 to +4: Cyclophosphamide Day +5: Tacrolimus from day +5 until taper day +100 (day +60 for peds if no acute or chronic GVHD present) Day +5: Mycophenolate mofetil through day +35 or 7 days after engraftment, whichever day is later, if no acute GVHD
15943471|NCT03314935|Drug|INCB001158|Phase 1: INCB001158 administered orally twice daily at the protocol-defined dose. Phase 2: INCB001158 administered orally twice daily at the recommended dose from Phase 1.
15943472|NCT03314935|Drug|Oxaliplatin|Oxaliplatin administered intravenously at the protocol-defined dose and schedule.
15943473|NCT03314935|Drug|Leucovorin|Leucovorin at the protocol-defined dose and regimen.
15943474|NCT03314935|Drug|5-Fluorouracil|5-Fluorouracil at the protocol-defined dose and regimen.
15943475|NCT03314935|Drug|Gemcitabine|Gemcitabine at the protocol-defined dose and regimen.
15943476|NCT03314935|Drug|Cisplatin|Cisplatin at the protocol-defined dose and regimen.
15943477|NCT03314935|Drug|Paclitaxel|Paclitaxel at the protocol-defined dose and regimen.
15943478|NCT03314922|Drug|Parsaclisib|Parsaclisib administered orally once daily for 8 weeks at the protocol-defined dose, followed by a once-weekly regimen at the same dose.
15943479|NCT03314909|Procedure|Hemodialysis|Participants in this group will be catheterize in the internal jugular vein and connect to a hemodialysis machine.
15943480|NCT03314909|Procedure|Hemoperfusion|Participants in this group will be catheterize in the internal jugular vein and connect to a hemoperfusion machine.
15943481|NCT03314909|Procedure|HP-HD|Participants in this group will be catheterize in the internal jugular vein and connect to a hemoperfusion machine and then a hemodialysis machine for one course.
15943482|NCT03314896|Procedure|Laparoscopic surgery|
15943483|NCT03314883|Diagnostic Test|D-US ARF|Diaphragm ultrasound evaluation in acute hypoxic - hypercapnic respiratory failure (ARF) patients undergoing non invasive ventilation, with regard to thickening (%) and excursion (millimeters)
15943484|NCT03314870|Genetic|Genetic signature|To identify molecular signatures of EMT / immune status by using the random forest algorithm. The best signature will be measured by RT-qPCR and/or CATS-RNASeq technics.
15943485|NCT03314857|Device|SAPIEN XT THV with the NovaFlex+ delivery system|Edwards SAPIEN XT™ Transcatheter Heart Valve along with NovaFlex+ delivery system
15943486|NCT03314818|Device|Ultrasound 3D Imaging|"Carotid artery ultrasound will be used to:
~Determine plaque presence and plaque burden Presence of stenosis
~Additionally, Carotid Intima-Media Thickness (IMT) will be measured and aortic diameter will be measured by abdominal aortic ultrasound scanning.
~Ultrasound of the Abdominal Aorta will be used to determine the presence and severity of stenosis or aneurism."
15943487|NCT03314805|Drug|Astragalus polysaccharides 500 mg|PG2 (500 mg in 500 ml saline), 3 days via i.v. infusion per chemotherapy cycle
15943488|NCT03314805|Drug|Placebo|500 ml saline, 3 days via i.v. infusion per chemotherapy cycle
15943489|NCT03314805|Procedure|EC Chemotherapy|Epirubicin plus Cyclophosphamide every 21 days
15943490|NCT03314792|Drug|Tapentadol|"Palexia depot 50 mg® (tapentadol depot 50 mg): Administered by the patient as oral premedication 1 hour before scheduled start of surgery. Palexia depot is repeated once after 12 hours.
~Palexia 50 mg® (tapentadol 50 mg): Administered as oral rescue medicine. First possible administration in postoperative ward when the patient is awake and available for oral medication. Maximum 4 tablets/24-hour study period. Minimum 1 hour 15 minutes between tablets. The patient is instructed to take 1 tablet if pain is increasing and the minimum period since last tablet is exceeded."
15943491|NCT03314792|Drug|Oxycodone|"OxyContin 10 mg® (oxycodone extended-release 10 mg): Administered by the patient as oral premedication 1 hour before scheduled start of surgery. OxyContin is repeated once after 12 hours.
~OxyNorm 10 mg® (oxycodone immediate-release 10 mg): Administered as oral rescue medicine. First possible administration in postoperative ward when the patient is awake and available for oral medication. Maximum 4 capsules/24-hour study period. Minimum 1 hour 15 minutes between capsules. The patient is instructed to take 1 tablet if pain is increasing and the minimum period since last tablet is exceeded."
15943492|NCT03314766|Device|IC-8 IOL|Patients previously implanted with an IC-8 IOL contralaterally or bilaterally will be evaluated for their long-term visual functions and overall satisfaction at least 12 months post-implantation
15943493|NCT03314753|Other|No interventions - retrospective data collection|No new patients will be enrolled within this project; only retrospective data will be collected on performed re-ablations within the FIRE AND ICE Trial
15943494|NCT03314740|Drug|Paclitaxel|Comparator active compound
15943495|NCT03314740|Drug|Cediranib|Experimental compound
15943496|NCT03314740|Drug|Olaparib|Experimental compound
15943497|NCT03314727|Other|High salt (NaCl) intake|Participants are asked to consume two high sodium-containing soups while monitoring their serum osmolarity levels
15943498|NCT03314714|Procedure|Acute bout of endurance exercise|Individuals will undergo an acute bout of endurance exercise for 90 min at 75% of maximal oxygen uptake.
15943499|NCT03314701|Device|Biphasic Intermittent Positive Airway Pressure (BIPAP)|"Following endotracheal intubation BIPAP mode will be started with:
~Inspiratory positive airway pressure [IPAP] at 20 cmH2O
~Expiratory positive airway pressure [EPAP] at 5 cmH2O
~PRESSURE SUPPORT is difference between these two pressures [IPAP]- [EPAP]
~Mandatory pressure will be delivered at rate of 10-12/min. To produce an end tidal carbon dioxide partial pressure in the range of 35-40 mmHg hypercapnia will not be allowed"
15943500|NCT03314701|Device|Airway Pressure Release Ventilation (APRV)|"high airway pressure (Phigh) will be set at 20 cmH2O
~low airway pressure ( Plow) will be set at 5 cmH2O
~the release phase setting will be adjusted to terminate the peak expiratory flow rate to ≥ 50%; release frequency of 10-12 cycles/min
~T high at 4.5-6 seconds
~T low at 0.5 to 0.8 second"
15943501|NCT03314688|Behavioral|Dietary/Physical Activity intervention|Motivational counseling to follow established dietary and exercise guidelines.
15943502|NCT03314688|Behavioral|Usual Care|Standard follow-up care and educational materials. Lifestyle counseling offered at the conclusion of the trial.
15943503|NCT03314675|Device|BIOTRONIK CRT-D|Pre-specified follow-up and measurements
15943504|NCT03314662|Biological|MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV)|The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for quadrivalent vaccines.
15943505|NCT03314662|Biological|Licensed MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine (aTIV-1)|The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines.
15943506|NCT03314662|Biological|MF59-adjuvanted Trivalent Subunit Inactivated Egg-derived Influenza Vaccine Containing the Alternate B Strain (aTIV-2)|The strain composition is that recommended by the World Health Organization for the 2017-2018 Northern Hemisphere influenza season (WHO, 2017) for trivalent vaccines except the B strain present in this vaccine is the second/alternate B strain recommended for inclusion in quadrivalent vaccines (ie, Alternate B strain).
15943507|NCT03314649|Other|Observational study|Lavage of the Peritoneal Cavity
15943508|NCT03314636|Drug|Carfilzomib|See in arm description
15943509|NCT03314636|Drug|Lenalidomide|See in arm description
15943510|NCT03314636|Device|PET-CT|See in arm description
15943511|NCT03314636|Drug|Dexamethasone|See in arm description
15943512|NCT03314623|Behavioral|Weight bearing as tolerated|If fracture is deemed stable the subjects will be allowed to weight bear immediately after surgery.
15943513|NCT03314610|Other|Gait speed|No intervention, only propose water and wait for need to void
15943514|NCT03314597|Other|Balance exercise|Patients in the balance exercise group received a personalized exercise program developed by an expert physiotherapist. There was no predefined duration for each item of the set of exercises, but all patients underwent an overall 45 min period training per day according to the same schedule. This schedule was based on the Otago Exercise Program and Practice Guidelines for the treatment of Parkinson's disease. Patients did not wear shoes for balance training. All exercises were performed without upper-limb support and with the supervision of a physiotherapist.
15943515|NCT03314597|Other|Mobile platform exercise|Patients entered the mobile platform and put on a security harness (no weight unloading), which they wore during the entire session on the platform training. The arms were free to move, but they were asked not to reach out for support. Each patient underwent 45 minutes of training (resting periods included), in which from 6 to 8 perturbation patterns were administered, each one lasting about 4 minutes. During training, the platform moved in the antero-posterior, latero-lateral and diagonal (45 deg) direction with respect to the body. The periodic platform displacement was 10 cm, regardless of the frequency, which could range from 0.3 to 0.6 Hz. Patients stood with eyes open and closed and feet together or 20 cm apart depending on the perturbation subtype.
15943516|NCT03314584|Device|Transcranial Magnetic Stimulation|Active-repetitive transcranial magnetic stimulation (rTMS) at the left motor cortex.
15943517|NCT03314584|Device|Sham Transcranial Magnetic Stimulation|Sham rTMS will consist of the same parameters as active, however, the subject will not receive the actual magnetic stimulation to the left motor cortex due to the use of a double sided Active/Sham coil used specifically for research studies.
15943518|NCT03314571|Other|analgesia for labor|A prospective database to study the determinants of labor pain and the resulting maternal non satisfaction.
15943519|NCT03314558|Other|pulmonary rehabilitation|a pulmonary rehabilitation program of 30 sessions, (3X1h/ week), will be followed by the COPD patients
15943520|NCT03314545|Procedure|laminate veneer with coronal post|laminate veneer with coronal post
15943521|NCT03314545|Procedure|post,core and crown|post,core and crown
15943522|NCT03314532|Procedure|TILA-TACE|After femoral artery catheterization, 5-Fr angiography catheters will be used for complete radiography of the celiac artery, the hepatic artery proper, left and right hepatic arteries and their branches, and 2.8-Fr micro-catheters will be used for complete radiography of the tumor's nutrient arteries. Lipiodol-epirubicin emulsions and 5% sodium bicarbonate injection solutions will be used for perfusion of chemotherapy drugs. Different sizes of embolic microspheres will be used alternatively for chemoembolization.
15943523|NCT03314519|Diagnostic Test|Lung ultrasonography by experienced anaesthesiologist|Use ultrasound image of lung at upper and lower lobe to detect lung collapse and compare grading of lung collapse by surgeon as gold standard
15943524|NCT03314519|Diagnostic Test|Fiberoptic bronchoscopy for double lumen tube's position|Use fiberoptic bronchoscope via double lumen tube to detect optimum position of double lumen tube and record grading of lung collapse by surgeon as gold standard
15943525|NCT03314506|Other|Exercise|Subjects will exercise on a treadmill for 1 hour at a moderate intensity (approximately 70% of their predicted VO2peak).
15943526|NCT03314493|Drug|Spironolactone 25Mg Tablet|Patients with coronary calcium score > 30 were treated with spironolactone for 12 months
15943527|NCT03314480|Diagnostic Test|Standardized physical examination|Standarized physical examination dedicated to assess a potential fracture in the maxillofacial or mandibular region.
15943528|NCT03314467|Diagnostic Test|polysomnography|"classical polysomnography
~non invasive measurement of blood pressure
~blood test: determination of HbA1c, glucose, C-peptide, hemoglobin, white blood cell count, trombocytes"
15943529|NCT03314454|Drug|Beer|Common brands beer with similar calorie (125-150) and alcohol level (approximately 4.5% ABV)
15943530|NCT03314454|Device|Videotaped drinking session|Video-assisted alcohol topography to explore its utility as an indicator of alcohol use disorder
15943531|NCT03314441|Behavioral|Yoga|4 yoga lessons with and instructors on a 3 months period. Patients are asked to exercise yoga daily for 5 to 30 minutes.
15943565|NCT03314168|Other|Combined training|Resistance exercises performed with different volumes (i.e. one-single set and multiple-sets) and 20-25 minutes of aerobic exercise will be performed twice a week, during 12 weeks.
15943566|NCT03314168|Other|Control group|The usual care will be recommended to avoid systematic physical exercise for 3 months and will receive general clinical recommendations such as nutritional intake and lifestyle issues in their respective hospital.
15943835|NCT03312114|Drug|Avelumab|Avelumab* (MSB0010718C; anti-PD-L1 is a fully human anti-PD- L1 IgG1 antibody)
15943532|NCT03314428|Behavioral|Gait retraining|Over a 4-week period, runners will be asked to increase their step rate to reduce knee loading during running. Specifically, they will have to increase their preferred step rate by 10% during weekly laboratory running sessions as well as during habitual running training. In the laboratory, runners will be provided with live visual/auditory biofeedback on step rate and asked to target a specific value representing 110% or preferred step rate. During their individual running sessions, runners will be wearing a GPS-enabled watch that will provide feedback on live step rate, and they will be asked to maintain the same value as in the laboratory.
15943533|NCT03314415|Device|Aldebaraan Nao H25|The Aldebaraan Nao H25 is a humanoid robot with the capability to interact with people through small movements, gestures, and speech. It does not physically touch the participant at any time.
15943534|NCT03314402|Drug|Jaktinib Dihydrochloride Monohydrate|Active Substance
15943535|NCT03314402|Drug|placebo|Placebo
15943536|NCT03314389|Device|Cochet bonnet esthesiometer|Cochet bonnet esthesiometer- To examine sensation
15943537|NCT03314376|Device|Prehabilitation program|"The intervention will be an 6-week program of individualized physiotherapy strength and muscular endurance with aerobic training, led by physiotherapists in groups of 8-10 participants. Each program will be individualized based on the evaluations of muscular strength and endurance as well as determination of aerobic-anaerobic zone transition described in previous studies In sessions of one hour 3 times a week. Each session will consist of 30 minutes of exercises performed on land followed by 20 minutes of continuous running in treadmill.
~In week 1 and 2 participants carry out 3 sets of 15 repetitions (reps) to become familiar with the exercises. From week 3 onwards participants will perform 4 sets of 10 reps. If the participant can do more than 12 reps, weight will be increased. All exercises are conducted supervised to ensure proper technique and adequate progression."
15943538|NCT03314363|Diagnostic Test|blood gas analysis under citrate predilution|blood gas analysis of blood on different sample points and dialysis fluid
15943539|NCT03314363|Device|filter replacement|Using local protocol: stop and disconnect CRRT, replace filter and reconnect and restart CRRT.
15943540|NCT03314363|Device|IC|monitor patients during the whole study period with indirect calorimetry
15943541|NCT03314363|Drug|NaCl predilution|Replace citrate predilution with NaCl
15943542|NCT03314363|Diagnostic Test|blood gas analysis under NaCl predilution|repeat blood gas analysis of blood on different sample points and dialysis fluid
15943543|NCT03314363|Drug|double ultrafiltration|double the ultrafiltration fluid by augmenting post dilution fluid and keeping ultrafiltration at the same rate.
15943544|NCT03314363|Diagnostic Test|blood gas analysis under citrate predilution and double ultrafiltration rate|repeat blood gas analysis of blood on different sample points and dialysis fluid
15943545|NCT03314363|Dietary Supplement|pause and restart nutritional therapy|pause parenteral and enteral nutrition before indirect calorimetry is performed. and restart after first blood analysis for vitamine status
15943546|NCT03314363|Diagnostic Test|evolution of vitamin and trace elements|blood analysis for vitamin and trace elements. Perform this blood analysis after restart of CRRT but before restart of nutritional therapy, 30 minutes after restart of nutritional therapy and 24h after restart of nutritional therapy.
15943547|NCT03314337|Device|Pancreatic stent: PSOF COOK®|After removing the distal pancreas, PSOF COOK will be place in the main pancreatic duct
15943548|NCT03314324|Drug|ODM-201|ODM-201: 600 mg (2 x 300 mg tablets) twice daily with food equivalent to a total daily dose of 1200 mg. ODM-201 should be taken at similar times day, approximately 12 hours between doses.
15943549|NCT03314324|Drug|Enzalutamide|Enzalutamide: 160 mg/day (4 x 40 mg tablets) taken once a day preferably with food, preferably in the evening (Enzalutamide can generally be given with or without food, but in the present trial, it is preferable that it is given with food, to be consistent with ODM-201 intake).
15943550|NCT03314311|Behavioral|Rehabilitation programme|The RESTORE trial is a 12 week multi-disciplinary intervention involving exercise, nutrition advice and education sessions
15943551|NCT03314298|Drug|testosterone anastrozole|subcutaneous testosterone and anastrozole
15943552|NCT03314285|Other|Sleep Quality|Sleep quality to be measured by the Pittsburgh Sleep Quality Scale.
15943553|NCT03314272|Device|Space Glucose Control|Development of a closed loop control system via Space Glucose Control that automatically infuses insulin on the basis of an automated algorithm, which integrates a continuous glucose signal, could help overcome these obstacles and permit strict glycemic control without increasing the workload.
15943554|NCT03314259|Drug|Tamsulosin|Tamsulosin is a alpha blocker and has a good safety profile that has been used extensively in Urological patients. Potential safety issues would include a minimal risk of orthostatic hypotension and hypersensitivity reaction to tamsulosin in our study population
15943555|NCT03314259|Drug|Placebo Oral Tablet|placebo is a tablet made to mimic tamsulosin tablet with same size and colour with no active ingredient
15943556|NCT03314246|Other|FAST|Fasting Algorithm for Singaporeans with Type 2 Diabetes
15943557|NCT03314246|Other|Standard of care|Standard of care
15943558|NCT03314233|Procedure|DING|"Immediately after birth, the infant will be placed on a Lifestart trolley with an intact umbilical cord, intubated, and ventilated with the Children's Hospital of Philadelphia (CHOP) gentle ventilation protocol."
15943559|NCT03314220|Behavioral|preoperative preparation|Participants in the experimental group received standard care plus our newly developed, multicomponent family-centered preoperative preparation program. This program included the following: (1) a tour of the preoperative area and recovery room; (2) a 4-min cartoon video entitled 'I am not afraid of surgery,' which was tailored to the child; this video included 29 scenes that depicted a boy's surgical journey with a particular emphasis on strategies for addressing postoperative pain; and (3) familiarization with medical equipment such as name badges, disposable hair caps, anesthetic masks, EKG leads, and pulse oximeters, which were placed on a doll, to help children understand the surgical instruments and promote better cooperation at the time of anesthesia induction.
15943560|NCT03314194|Other|Plant Based Diet|Plant Based Diet for 4 Days Compared to Habitual Diet
15943561|NCT03314181|Drug|Dexamethasone|Infusion; Intravenous (IV), or Tablet; Oral
15943562|NCT03314181|Drug|Daratumumab|Injection; Subcutaneous (preferred), Infusion; Intravenous (IV)
15943563|NCT03314181|Drug|Venetoclax|Tablet; Oral
15943564|NCT03314181|Drug|Bortezomib|Injection; Subcutaneous (preferred), Infusion; Intravenous (IV)
15943568|NCT03314142|Other|Glucose as reference food|Ten subjects (male: 7, female: 3) consumed 50g glucose diluted in 250ml water, tested three times, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
15943569|NCT03314142|Other|White bread as reference food|Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from white bread along with 250ml water, tested twice, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120min.
15943570|NCT03314142|Other|Bread enriched with coarse wheat bran|Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from bread enriched with coarse wheat bran along with 250ml water, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
15943571|NCT03314142|Other|Bread enriched with fine wheat bran|Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from bread enriched with fine wheat bran (obtained by milling of the coarse bran) along with 250ml water, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
15943572|NCT03314142|Other|Bread enriched with fine wheat bran and carob seed flour|Ten subjects (male: 7, female: 3) consumed 50g available carbohydrates from bread enriched with fine wheat bran (obtained by milling of the coarse bran) in which 10% of the flour was substituted with carob seed flour (CSFB) along with 250ml water, tested once, in different weeks, within 5-10min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
15943573|NCT03314129|Behavioral|UltimEyes|A computer program developed to improve contrast sensitivity and visual acuity.
15943574|NCT03314129|Behavioral|Contour Integration Training|A computerized program to improve contour integration (a form of perceptual organization).
15943575|NCT03314129|Behavioral|UltimEyes + Contour Integration Training|The combination of UltimEyes and Contour Integration Training
15943576|NCT03314129|Behavioral|MyBrainSolutions|A computer program consisting of exercises to improve cognition (attention, memory, planning) and to facilitate goal setting.
15943577|NCT03314116|Other|Guidance on auditory protection|by video or medic
15943578|NCT03314103|Biological|One shot of the varicella-zoster virus vaccine|One shot of the live attenuated varicella-zoster virus vaccine (with live virus >=4.3 LgPFU per dose)
15943579|NCT03314103|Biological|one shot of placebo|one shot of placebo with no live virus
15943580|NCT03314090|Drug|Silicone Gels|silicone gel (Dermatix Ultra, Menarini, Singapore) was applied twice per day. The amount used being similar in size to a grain of rice.
15943581|NCT03314077|Other|GOLD 2017|Standard COPD management according to GOLD 2017, and control the quality of management in one-year follow-up.
15943582|NCT03314064|Drug|Dolutegravir 50 mg|DTG is an integrase inhibitor that has been developed for ART of HIV-infection in combination with other antiretrovirals. DTG will be available as 50 mg tablets to be administered once daily.
15943583|NCT03314025|Drug|Tamsulosin Hydrochloride 0.4 MG|Peri-operative therapy of Tamsulosin Hydrochloride 0.4 milligrams daily for a total of 7 days.
15943584|NCT03314025|Drug|Placebo oral capsule|Peri-operative therapy of a Placebo oral capsule daily for a total of 7 days.
15943585|NCT03314025|Device|Foley catheter|Every patient with a post-operative urinary retention will have a foley catheter, as standard of care.
15943586|NCT03314012|Device|Catheter-Based Carotid Body Ablation|The Cibiem Transvenous Ultrasound System (CTUS) is a catheter based device delivering ultrasound energy to ablate the carotid body. The procedure is done via a percutaneous insertion of the CTUS and advancement through the femoral vein to the jugular vein in subjects with difficult to control hypertension. The procedure duration is expected to range between 60 to 90 minutes and is performed under fluoroscopic and ultrasound image guidance.
15943587|NCT03313999|Device|Lymphedema Indentometer|The subject will sit down. The machine will be placed over their extremity/affected region. They will then be told the machine will be activated. They may or may not feel the machine touch them. A small pressure will be applied to the skin surface for 4 seconds. The computer will record the skin elasticity as change in resistance to compression over time during these 4 seconds. The entire procedure will take about a minute or less, after which the standard of care visit with the physical therapist will continue.
15943588|NCT03313973|Procedure|with self stretching same muscle|with self stretching
15943589|NCT03313973|Procedure|with self stretching of forearm muscles|without self stretching
15943590|NCT03313960|Drug|"Afrezza plus One Drop | Premium"|"Participants in this group will receive insulin inhalation, prescribed by their physician, and will also receive One Drop | Premium (i.e., One Drop | Experts in-app coaching from a Certified Diabetes Educator (CDE) along with One Drop | Chrome Bluetooth-connected blood glucose meter that uploads results into the One Drop | Mobile app and 150 test strips per month for three months)."
15943591|NCT03313960|Other|"One Drop | Premium"|"Participants in this group will receive One Drop | Premium (i.e., One Drop | Experts in-app CDE coaching with the One Drop | Chrome Bluetooth-connected blood glucose meter that uploads results into the One Drop | Mobile app and 150 test strips per month for three months)."
15943592|NCT03313947|Procedure|Ultrasound|Ultrasound to measure hyo-mental distance, neutral (Frankfort) position, maximal extended neck position to calculate ratio, width of the tongue between the lingual arteries, and tonsillar size (bilateral).
15943593|NCT03313947|Other|Questionnaire|"The following 6 questions will be asked during the preoperative visit:
~While sleeping, does your child snore more than half the time?
~While sleeping, does your child always snore?
~Have you ever seen your child stop breathing during the night?
~Does your child occasionally wet the bed?
~Did your child stop growing at a normal rate at any time since birth?
~Is your child overweight"
15943594|NCT03313934|Combination Product|Hyaluronic Acid Filler and Platelet Rich Fibrin (PRF)|The use of Restylane-L to volumize the tear trough has been well documented. Combining Restylane-L with Platelet Rich Fibrin (PRF) will be studied to evaluate if PRF enhances the volumization and skin quality of the treated areas.
15943642|NCT03313635|Diagnostic Test|Men presenting with low-T|Evaluation of prealbumin levels.
15943595|NCT03313934|Combination Product|Hyaluronic Acid Filler and Saline|This intervention will use saline as a control to compare with PRF when mixed with hyaluronic acid fillers. Saline will dilute the HA filler in the same way PRF will, however saline as no growth factors or properties that will enhance treatment.
15943596|NCT03313921|Diagnostic Test|Online Manifest Refraction|"The online manifest refraction is performed with a web-based application and consists of an assessment of visual acuity, an assessment of spherical refractive error, and an assessment of cylinder refractive error. The software is a class 1 CE-approved medical device.
~The automated refraction is measured with a regular office-based autorefractor device; TOPCON RM-8000."
15943597|NCT03313908|Procedure|detection of the tumor lesion|non palpable tumor detection with indocyanine green fluorescence and radioactive seed localization
15943598|NCT03313895|Behavioral|ACT|ACT stands for combined aerobic exercise and cognitive training.
15943599|NCT03313895|Behavioral|Cycling Only|Cycling on a recumbent stationary cycle
15943600|NCT03313895|Behavioral|Cognitive Training Only|Engage in cognitive training on a computer
15943601|NCT03313895|Behavioral|Stretching and Mental Stimulating Activities|Stretching exercises and mental stimulating activities on a computer
15943602|NCT03313882|Other|no intervention is involved|
15943603|NCT03313869|Dietary Supplement|XXS-2A + Omega-3 + Vitamin E + Selenium|Micronutrient cocktail supplementation with 560,7 mg/ day of polyphenols (3 pills/day), 2,1 g/day of omega-3 fatty-acids (3 pills/day), 168 mg/day of vitamin E and 80µg/day of selenium (1 pill/day)
15943604|NCT03313869|Dietary Supplement|control diet|habitual diet to be followed
15943605|NCT03313856|Drug|Guazuma Ulmifolia plus Tecoma Stans|Guazuma ulmifolia (313.6 mg) -Tecoma stans (86.4 mg) = 400 mg per capsule
15943606|NCT03313856|Drug|Calcinaned magnesia|Calcined magnesia 400 mg per capsule
15943607|NCT03313830|Dietary Supplement|Whey Protein Hydrolysate (WPH)|Subjects will ingest WPH on one occasion.
15943608|NCT03313830|Dietary Supplement|Intact Whey Protein (WHEY)|Subject will ingest WHEY on another occasion.
15943609|NCT03313817|Device|Additional MRI sequences|"Patients will be hospitalized for suspicion of CRAO. An optimized MRI will be performed with specific sequences: 3D T1 MSDE (Motion Sensitized Driven Equilibrium) dark blood; 3D Optimized diffusion centered on the optic nerves; 3D PD T1 after injection. A consultation of ophthalmology and a control MRI will be carried out one month after the CRAO. Again, specific sequences will be added: 3D T1 MSDE (Motion Sensitized Driven Equilibrium) dark blood; 3D Optimized diffusion centered on the optic nerves; DTI (Diffusion Tensor Imaging); 3D PD T1 after injection."
15943610|NCT03313804|Drug|Immune checkpoint inhibitor|Standard of care immune checkpoint inhibitor
15943611|NCT03313804|Radiation|Radiation Therapy|Stereotactic Body Radiation Therapy OR Fractionated radiation therapy
15943612|NCT03313791|Dietary Supplement|Whey protein concentrate|see arm description
15943613|NCT03313791|Dietary Supplement|Yoghurt|see arm description
15943614|NCT03313791|Dietary Supplement|50%whey-50% casein (Standard)|see arm description
15943615|NCT03313791|Dietary Supplement|50%whey-50% casein (Alternative)|see arm description
15943616|NCT03313791|Dietary Supplement|Micellar Casein Isolate- WPH|see arm description
15943617|NCT03313791|Dietary Supplement|Micellar Casein Isolate - Na-caseinate|see arm description
15943618|NCT03313791|Dietary Supplement|Micellar Casein Isolate|see arm description
15943619|NCT03313791|Dietary Supplement|UHT milk|see arm description
15943620|NCT03313791|Dietary Supplement|Recombined milk|see arm description
15943621|NCT03313791|Dietary Supplement|Recombined 50%whey milk|see arm description
15943622|NCT03313791|Dietary Supplement|Ca-caseinate|see arm description
15943623|NCT03313791|Dietary Supplement|Milk protein isolate|see arm description
15943624|NCT03313778|Biological|mRNA-4157|Personalized cancer vaccine, IM injection
15943625|NCT03313778|Biological|Pembrolizumab|Intravenous infusion
15943626|NCT03313765|Behavioral|Motivational interviewing (MI)|Brief MI intervention
15943627|NCT03313765|Other|Standard-of-care|Standard-of-care education and counseling
15943628|NCT03313752|Drug|Dapagliflozin 10Mg Tab|Dapagliflozin, will be administered according to the approved posology and to the approved dose as stated by Local Health Indication and by the Drug Brochure
15943629|NCT03313752|Other|Placebo|placebo
15943630|NCT03313739|Other|An Educational Program|An educational program was designed for self-care during menopause using teach back method.
15943631|NCT03313726|Drug|GnRH antagonist|Administration of GnRh antagonist after baseline PSMA-PET at day 0 and then repeated PSMA-PET scans at day 7, day 14 and day 28 to define the timeframe of the SUV-max.
15943632|NCT03313726|Drug|GnRH antagonist|Administration of GnRh-antagonist after baseline PSMA-PET at day 0 and then repeated scan at day in which SUV-max was observed in the Arm A (day 7, day 14 or day 28). Then robot assisted radical prostatectomy and lymphadenectomy are performed to verify the finding.
15943633|NCT03313713|Dietary Supplement|Beta-glucans|Placebo consumption at breakfast (3 g per day)
15943634|NCT03313713|Dietary Supplement|Placebo|Placebo consumption at breakfast (3 g per day)
15943635|NCT03313700|Procedure|Robotic Distal Gastrectomy|After exclusion of T4b, bulky lymph nodes, or distant metastasis case, robotic distal gastrectomy will be performed in the experimental group.
15943636|NCT03313700|Procedure|Laparoscopic Distal Gastrectomy|After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic distal gastrectomy will be performed in the comparator group.
15943637|NCT03313674|Device|Bright Light Therapy|Light box that emits light at 10,000 lux or higher and has been demonstrated to regulate circadian rhythm that is aberrant in the SAD population
15943638|NCT03313661|Drug|Cabergoline|cabergoline 0.5 mg twice weekly within 2 hrs of awakening plus gliclazide
15943639|NCT03313661|Drug|Gliclazide|gliclazide (60-120 mg)
15943640|NCT03313648|Procedure|Laparoscopic Hepatectomy|180 patients with recurrent HCC with recurrent nodular diameters of less than 5 cm and up to three nodules were randomly divided into LH (n=90) and RFA groups (n=90). Outcomes were monitored and evaluated during the 5-year follow-up period.
15943641|NCT03313648|Procedure|Radiofrequency Ablation|180 patients with recurrent HCC with recurrent nodular diameters of less than 5 cm and up to three nodules were randomly divided into LH (n=90) and RFA groups (n=90). Outcomes were monitored and evaluated during the 5-year follow-up period.
15943643|NCT03313622|Behavioral|Beads Task|Participants will be asked to make a series of decisions that involve combining information about the value and probability of potential rewards. Subjects will sit in front of a computer monitor and place their hand over a box with orange and blue button that they will be asked to press based on their idea of which one will be the majority in a jar full of orange and blue beads. This task should take 15-20 minutes to complete, not including EEG setup.
15943644|NCT03313622|Behavioral|PROVOC Tasks|Three tasks will be developed collaboratively with the participant and independent evaluator that involve the participant being exposed to triggers that are considered by him/her impossible to confront without ritualizing. There will also be a similar process involving objects that should not cause any distress to be used as a control. Sessions will be videotaped with AFAR system concurrent to recording of LFPs from VS and scalp EEG.
15943645|NCT03313609|Behavioral|Investigating Burnout in Intensive Care in Middle Incoming Turkey|single-group studies
15943646|NCT03313596|Drug|ADV-Tk|The first ADV-TK dose was administered during the operation; 1.0×10(12) viral particles of ADV-TK in 100 mL of 0.9% saline were injected into peritoneum tissues around the liver. The second and third ADV-TK dose was administered 60 days and 90 days after LT; 1.0×10(12) viral particles of ADV-TK in 100 mL of 0.9% saline were injected into the celiac artery (60 mL) and the superior mesenteric artery (40 mL) via femoral-artery puncture.
15943647|NCT03313596|Procedure|LT|Orthotopic LT and subsequent immunosuppression therapy
15943648|NCT03313583|Procedure|Transfusion of blood products|
15943649|NCT03313557|Drug|Wee-1 kinase inhibitor AZD1775|Patients will receive AZD1775 300 mg orally once daily. Days 1 to 5 and 8 to 12 of a 21 day cycle (ie, 5 days on and 2 days off for Weeks 1 and 2 of a 21-day cycle). All patients must receive a serotonin receptor 3 (5-HT3) antagonist, ondansetron (Zofran) 8 mg orally/IV or granisetron (Kytril) 1 mg orally/IV prior to each dose of AZD1775. Dexamethasone 4 mg orally/IV will be given with each AZD1775 dose at a minimum on the first day of dosing of AZD1775 of every 5 day dosing period, unless contraindicated or not well-tolerated.
15943650|NCT03313544|Drug|Nivolumab|NIVOLUMAB
15943651|NCT03313544|Device|MRI|Cardiac MRI 6 MONTHS
15943652|NCT03313544|Biological|BLOOD SAMPLES|biological (BNP and troponin)
15943653|NCT03313544|Device|trans-thoracic echocardiography|1, 3 and 6 months
15943654|NCT03313531|Diagnostic Test|Thrombin Generation Assay|Inter lab variation and level of agreement will be determined
15943655|NCT03313531|Drug|Treatment with recombinant coagulation factor|To obtain a wide range of thrombingeneration levels, one person (Treated HA person) will recieve one injection of Advate and one injection of Adynovate respectively
15943656|NCT03313518|Device|tDCS|15 patients received real anodal tDCS for 20 minutes daily for 10 consecutive days.
15943657|NCT03313518|Device|Sham tDCS|15 patients received sham anodal tDCS for 20 minutes daily for 10 consecutive days.
15943658|NCT03313505|Biological|S100B protein dosage|S100B protein dosage will be carried out, by a blood sample, on the earliest after admission and before 3th hour following brain injury S100B protein dosage will be left to the assessment of the emergency physician in charge of the patient
15943659|NCT03313505|Other|Brain CT scan|No injected brain CT-scan, regardless of the time between the brain injury and the arrival in the emergency unit. Realization of CT-scan will be left to the assessment of the emergency physician in charge of the patient
15943660|NCT03313492|Behavioral|UV4.me2|"UV4.me2 is an enhanced version of the original UV4.me web intervention and features the many of the same educational material and interactive components. New features/strategies for reach, effectiveness, and implementation include:
~A mobile version of the site
~Incentives in the form of clickable coupons and links to free samples for sun protection products (e.g., sunscreen)
~Behavioral tracking and feedback, where users can set goals, track their progress, and receive tailored feedback"
15943661|NCT03313492|Behavioral|UV4.me|Original version of the UV4.me website, which offers education and tailored responses to interactive quizzes about current sun protective behaviors and barriers to engaging in sun protective behaviors.
15943662|NCT03313492|Behavioral|E-Pamphlet|"A free non-interactive e-pamphlet (Skin Cancer Prevention and Early Detection from the American Cancer Society). Includes information on skin cancer risk and prevention."
15943663|NCT03313479|Drug|Dexmedetomidine|Dexmedetomidine will be given with GS
15943664|NCT03313466|Behavioral|Internet cognitive behavioral therapy for insomnia (iCBTI)|An internet-based program for providing individually tailored CBTI based on participant responses to questions and performance on weekly guided sleep strategies.
15943665|NCT03313466|Behavioral|Class in sleeping well and improving insomnia|A group education session providing advice on healthy sleep habits and ways to improve common forms of insomnia.
15943666|NCT03313453|Device|PuriCare (HEPA Air Cleaner)|The active comparator group is a group that uses machines that have the same functions as those on the market. In intervention group, two air-cleaners will be activated, one in the living room (covers 91 m2) and the other in the bedroom (covers 58 m2). The air cleaner will be operated continuously for 6 weeks. Inside the air cleaner, a device for measuring the quality of the indoor air is built in. It will be used to compare indoor air quality before and after air cleaner operation. In order to maintain the double-blind setting, a label for 'prohibition of opening' will be attached to the joint of the outer case, and a sticker to cover the air quality measurement display part built in the air cleaner itself will be attached.
15943667|NCT03313453|Device|Mock device of PuriCare|The Control group operates the air-cleaner with the same appearance as the experiment group. However, all the filters including HEPA filter will not be inserted in this group (mockup devices). Two mockup air-cleaners will be activated, one in the living room (covers 91 m2) and the other in the bedroom (covers 58 m2). The mockup devices will be operated continuously for 6 weeks. Same as active comparator group, a device for measuring the quality of the indoor air is built in the mockup air cleaner. It will be used to compare indoor air quality before and after air cleaner operation. In order to maintain the double-blind setting, a label for 'prohibition of opening' will be attached to the joint of the outer case, and a sticker to cover the air quality measurement display part built in the air cleaner itself will be attached.
15943668|NCT03313440|Other|High wheat fiber|Daily increased fiber intake by 18-22 grams/day. Products are provided in boxes that must be consumed each day during the intervention.
15943669|NCT03313440|Other|Low fiber|Control low fiber intervention. Products are provided in boxes that must be consumed each day during the intervention.
15943946|NCT03311243|Drug|Chemical plaque control|
15943670|NCT03313427|Other|Physical Therapy Early Intervention|"At the UCIN:
~Parental education to empower them on motor development and parent-infant relationship. Consisted on 6 sessions during the first weeks at the NICU.
~Tactile and kinaesthetic stimulation managed by parents. 2 times a day, 15 minutes each, during 10 days.
~At home:
~Psychomotor Development Program for the baby; comprised of different exercises, in different phases, depending on child maturation stage. Started after hospital discharge until 2 months corrected age."
15943671|NCT03313427|Other|Usual Care|NICU usual care
15943672|NCT03313414|Drug|Sofosbuvir/Velpatasvir Treatment for 14 days|14 day therapy with Sofosbuvir/Velpatasvir
15943673|NCT03313401|Drug|Aflibercept|Intravitreal aflibercept injection
15943674|NCT03313401|Device|Specular microscopy|Specular microscopy measurement after intravitreal aflibercept injection
15943675|NCT03313388|Dietary Supplement|Drink|Beverage to be consumed
15943676|NCT03313375|Other|Continuous Exercise|Subjects will be asked to perform a 45 min exercise bout. 10 minutes will be a warmup (at a work rate associated with 50% heart rate max), 30 minutes at a wattage that elicits 75-80% heart rate max, and a 5 minute cool down period, returning them to approximately 50% heart rate max.
15943677|NCT03313375|Other|Aerobic Interval Exercise|Subjects will be asked to complete a 43 minute exercise session. To warm up, subjects will cycle at a work rate associated with 50% HRmax for 10 minutes. Wattage will then increase and subjects will do four 4-minute intervals at a work rate associated with 90%-95% HRmax, separated by 3 minutes of active recovery at a work rate associated with 50% HRmax. Subjects will be given a 5-minute cool-down period at a work rate associated with 50% HRmax.
15943678|NCT03313362|Device|SPEAC System|Seizure Monitoring and Alerting System
15943679|NCT03313362|Device|video EEG|The Video EEG Monitoring Test (VEEG) is a high specialized form of an EEG test in where the patient is continuosly monitored by using a video recorder. This allows doctors to observe brainwaves activity during the time a seizure or spell is occurring.
15943680|NCT03313349|Behavioral|Psychotherapy: 1. cognitive therapy 2.family intervention|Psychotherapy delivered by trained psychologist for the student and the student´s parents
15943681|NCT03313336|Drug|EMLA test patch|EMLA® Test Patch containing the active ingredients lidocaine base 25 mg/g and prilocaine base 25 mg/g in an oil-in-water emulsion saturating the absorbent cellulose disc. The source of cellulose for the cellulose disc will be provided from a new supplier in this test patch.
15943682|NCT03313336|Drug|EMLA current reference patch|EMLA current Reference Patch, containing the active ingredients lidocaine base 25 mg/g and prilocaine base 25 mg/g in an oil-in-water emulsion saturating the absorbent cellulose disc.
15943683|NCT03313336|Drug|Placebo Patch|Placebo Patch, based on the EMLA Test Patch (incorporating the absorbent cellulose disc with cellulose from the current supplier), where the absorbent disc will be saturated with a placebo oil-in-water emulsion, where the eutectic mixture of lidocaine and prilocaine is replaced with fractionated coconut oil and chlorhexidine digluconate 20%, with identical appearance to the active EMLA patches.
15943684|NCT03313323|Biological|89Zirconium-labeled ipilimumab|Metastatic melanoma patients, who are treated with ipilimumab (3 mg/kg), will be infused with 89Zr-labeled ipilimumab within 2 hours after injection of the first and second standard ipilimumab doses. Peripheral blood mononuclear cells (PBMCs) will be collected for immunomonitoring.
15943685|NCT03313310|Behavioral|Employment Intervention|Participants will complete 4 workshop sessions in groups of 6-12. The workshop curriculum was based on the pre-existing iFOUR program, and tailored based on feedback from a Community Advisory Board (CAB), Focus Groups, and In Depth Interviews.
15943686|NCT03313297|Drug|AZD4017|AZD4017 is a novel orally bioavailable small molecule inhibitor of 11β-HSD1 enzyme activity. It is potent and highly selective in vitro and in vivo. The half maximal inhibitory concentration (IC50) for inhibition of 11β-HSD1 activity (cortisone to cortisol conversion) is 2nM. AZD4017 is selective (> 2000x) for 11β-HSD1 over human recombinant 11β-HSD2 and the closely-homologous enzymes 17β-hydroxysteroid dehydrogenase 1 and 17β-hydroxysteroid dehydrogenase 3 in vitro.
15943687|NCT03313297|Drug|Placebo|Matching placebo
15943688|NCT03313284|Procedure|RMT|RMT consists of six bouts of 5-min of volitional hyperpnoea . After each RMT bout, participants will breathe room air for 5 minutes.
15943689|NCT03313284|Procedure|RMT + IH|RMT and IH consist of six bouts of 5-min of volitional hyperpnoea. After each RMT bout, participants will breathe a hypoxic gas mixture (10.5% O2 ) for 5 minutes.
15943690|NCT03313284|Procedure|Control|No intervention
15943691|NCT03313258|Device|Standard of Care Group|ZHF temperature monitor cable will be placed appropriately on the forehead by the care team under the direction of the research personnel. The research personnel will then connect this cable to a screen that is blinded to the care team but not to the research personnel.
15943692|NCT03313258|Device|Active Warming Group|ZHF temperature monitor cable will be placed appropriately on the forehead by the care team under the direction of the research personnel. The research personnel will then connect this cable to a screen that is un-blinded to everyone so healthcare practitioners will be able to visually detect continuous temperature readings from the ZHF monitor.
15943693|NCT03313245|Other|No Intervention/Observational Study|No Intervention/Observational Study
15943694|NCT03313232|Other|ROAT with oxidized R-limonene at 1%, 0.3% and 0.1%|A twice daily repeated open application test (ROAT) study for up to three weeks of exposure to oxidized R-limonene at 1%, 0.3% and 0.1% concentrations
15943695|NCT03313232|Other|ROAT with oxidized R-limonene at 1%|A twice daily repeated open application test (ROAT) study for up to three weeks of exposure to oxidized R-limonene at a 1% concentration
15943696|NCT03313219|Drug|Gentuximab Injection|Gentuximab Injection (Recombinant anti-VEGFR2 human-mouse chimeric monoclonal antibody injection)
15943697|NCT03313206|Drug|Pembrolizumab|"Neo-adjuvant therapy :
~Anti-PD1 antibody will be used (pembrolizumab, Merck®) intravenously at a dose of 200 mg every 3 weeks. The patient will receive 4 injections maximum over 12 weeks. According to the investigator's opinion, the 4th injection might be cancelled in order to perform surgery from week 10 and not after week 13.
~Tumor response will be assessed 2 weeks after the last injection both clinically and radiologically (by CT-scan and MRI).
~Maintenance therapy by anti-PD1 antibody (pembrolizumab, Merck®) will be then used intravenously at a dose of 200 mg every 3 weeks for a maximum period of one year, starting one month after the end of radiotherapy."
15943801|NCT03312413|Drug|Normal Saline|Normal saline 0.5 mL·h-1 will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery
15943698|NCT03313206|Procedure|Surgery|Surgery will be performed (endoscopically if possible) 3 weeks after the last injection, at the earliest week 10 and at the latest at week 13 and will be completed by radiotherapy using IMRT technology according to the International and European Rhinologic Societies guidelines.
15943699|NCT03313206|Radiation|IMRT|Surgery will be performed (endoscopically if possible) 3 weeks after the last injection, at the earliest week 10 and at the latest at week 13 and will be completed by radiotherapy using IMRT technology according to the International and European Rhinologic Societies guidelines.
15943700|NCT03313193|Other|Acupressure for Children in Treatment for a Childhood Cancer|This study will describe the benefits and risks of an acupressure intervention to decrease nausea/vomiting and other treatment-related symptoms compared to a control group receiving usual care. Children in Arm A will receive usual symptom management care + acupressure 5 days/week for ~20 treatments. Parents will be taught how to provide acupressure as well. Children in Arm B will receive usual care alone.
15943702|NCT03313167|Other|Non-interventional|Non-interventional
15943703|NCT03313154|Other|Neuropsychiatric screening|"Psychiatric diagnosis through:
~clinical interview
~the Advanced Neuropsychiatric Tools and Assessment Schedule (ANTAS), based on the SCID-I-NP (Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders-Non Patient Version);
~HAM-D (Hamilton Scale for Depression);
~PHQ-9 (Patient's Health Questionnaire-9 items);
~MDQ (Mood Disorders Questionnaire);
~YMRS (Young Mania Rating Scale);
~ASRM (Altman Self Rating Mania scale);
~BRIAN (Biological Rhythms Interview of Assessment in Neuropsychiatry).
~Assessment of Quality of Life:
~SF-12 (Short Form Health Survey-12 items).
~Neuropsychological screening:
~l) Addenbrooke's Cognitive Examination (ACE-R)."
15943704|NCT03313141|Diagnostic Test|Ultrasound|Volitional and non volitional respiratory tasks
15943705|NCT03313128|Other|Sanitation|Improved sanitation facility
15943706|NCT03313115|Behavioral|Sleep/Wake Protocol|"Day RN observes if completed per pt: no caffeine after 3 pm, encourage activities to prevent napping (chart % day spent napping), Lights on blinds/door open, Reasonable effort for some noise in room, Eye glasses hearing aids applied, Chair position/mobility at least 2x30 minutes.
~Night RN observe if completed per pt: Appropriate pain control, Optimize room temp, Warm bath before 2200, TV off by 2200, Prevent extra alarms after 2200, Close room curtain by 2200, Dim room lights by 2200, Family out by 2200, Door half/fully closed after 2200, # RN interruptions after 2200, Offer eye mask/ear plugs, Meds administered for sleep (dilaudid, fentanyl oxycodone, haldol, quetiapine, propofol, melatonin, or other), Dim hallway lights by 2200, Nurses station quiet"
15943707|NCT03313102|Biological|blood samples|sample of 16 blood tubes
15943708|NCT03313089|Behavioral|"Papas más nutritivas (PSAN)"|"Activities of the project Papas más nutritivas"
15943709|NCT03313076|Drug|Omega-3 fatty acids (fish oil)|4 capsules comprising approximately 2 grams of Eicosapentaenoic acid/Docosahexaenoic acid (EPA/DHA) in a 3:2 ratio (this will require a total dose of 4 grams of fish oil). This will be administered daily, by mouth for 6 weeks
15943710|NCT03313076|Drug|Vitamin D3 (cholecalciferol)|1 capsule containing 2000 IU of Vitamin D3. This will be administered daily, by mouth for 6 weeks following enrollment.
15943711|NCT03313076|Drug|Vitamin D3 (cholecalciferol) placebo|1 capsule containing inert substance. This will be administered daily, by mouth for 6 weeks following enrollment.
15943712|NCT03313076|Drug|Omega-3 fatty acid placebo|4g of corn/soy oil blend in 4 softgels. This will be administered daily, by mouth for 6 weeks following enrollment.
15943713|NCT03313050|Biological|Multivalent|Pneumococcal conjugate vaccine
15943714|NCT03313050|Biological|Tdap|Tetanus, diphtheria, acellular pertussis vaccine
15943715|NCT03313050|Biological|polysaccharide|23-valent pneumococcal polysaccharide vaccine
15943716|NCT03313037|Biological|Multivalent|Pneumococcal conjugate vaccine
15943717|NCT03313037|Biological|Prevnar 13|Pneumococcal conjugate vaccine
15943718|NCT03313037|Biological|PPSV23|Pneumococcal polysaccharide vaccine
15943719|NCT03313037|Other|Saline|Placebo
15943720|NCT03313011|Diagnostic Test|Testing protocol for the study|All patients will see a Neurologist for a neuro exam and consult, see a Speech Pathologist for assessment of speech and language skills, see the Study Coordinator for neuropsych testing (brief tests of thinking, memory, visual spatial skills, etc), undergo an MRI of the brain and a DaTscan of the brain.
15943721|NCT03312998|Radiation|Xrays|Plain x-rays anteroposterior and lateral views to determine system failure
15943722|NCT03312985|Procedure|ACAF surgery|The main surgical procedures include discectomy of the involved levels, thinning of the anterior part of the involved vertebrae, intervertebral cages, anterior plate and screws installation, bilateral osteotomies of the vertebrae, and antedisplacement of the vertebrae-OPLL complex
15943723|NCT03312985|Procedure|ACCF surgery|Removal of the vertebral body，exposed ossification of the posterior longitudinal ligament，and then removed
15943724|NCT03312972|Radiation|HDR Brachytherapy|HDR Brachytherapy implant, deliver 1 to 2 fractions, Up to 30 Gray (Gy) to target lesion
15943725|NCT03312959|Drug|hyperbaric bupvacaine in Peribulbar block|hyperbaric bupivacaine in Peribulbar block will be injected in the posterior segment surgery
15943726|NCT03312959|Drug|isobaric bupvacaine in Peribulbar block|isobaric bupivacaine in Peribulbar block will be injected in the posterior segment surgery
15943727|NCT03312946|Device|Modellata|treatment such as the Modellata electromedical device (Ibramed), in the abdomen, flanks, thigh posterior, inner thigh and buttocks.
15943728|NCT03312920|Device|active anodal tDCS|active anodal tDCS with memory task
15943729|NCT03312920|Device|sham tDCS|sham tDCS with memory task
15943730|NCT03312920|Device|active cathodal tDCS|active cathodal tDCS with memory task
15943731|NCT03312907|Drug|Belimumab|Belimumab will be administered as SC injection once weekly via autoinjector in thigh or abdomen
15943732|NCT03312907|Drug|Rituximab|Rituximab will be administered as IV infusion of 1000mg at Week 4 and Week 6
15943733|NCT03312907|Drug|Rituximab-placebo|Saline will be administered as IV infusions at Week 4 and Week 6
15943734|NCT03312907|Drug|Standard therapy (Including Immunosuppressants)|Standard therapy will contain stable SLE medications including immunosuppressant to be administered from baseline through Week 104.
15943800|NCT03312413|Drug|Dexmedetomidine Hydrochloride|Dexmedetomidine Hydrochloride 0.2 μg·kg-1·h-will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery
15943735|NCT03312907|Drug|Standard therapy (Excluding Immunosuppressants)|Standard therapy excluding Immunosuppressant will contain anti-malarials, NSAIDs, and/or corticosteroids with presdnisone dose equivalent to <= 5 mg/day will administered by subjects in Arm A and B through Week 104.
15943736|NCT03312907|Drug|Steroid Taper|Steroid taper will include prednisone doses equivalent to =< 5 mg/day in all Arms through Week 104.
15943737|NCT03312894|Drug|TAK-653|TAK-653 tablets
15943738|NCT03312894|Drug|Placebo|Placebo-matching tablets
15943739|NCT03312881|Diagnostic Test|quantitative sensory testing|multiple modality testing of generalized and localized changes in somatosensory perception
15943740|NCT03312881|Diagnostic Test|neuroimaging|magnetic resonance imaging (MRI)
15943741|NCT03312881|Other|Patient Reported Outcome Measures|neuropathic pain screening tool; validated questionnaires
15943742|NCT03312868|Radiation|SBRT|Stereotactic Body Radiotherapy
15943743|NCT03312855|Drug|Revacept 80 mg|single dose, intravenous application of 80 mg Revacept
15943744|NCT03312855|Drug|Revacept 160 mg|single dose, intravenous application of 180 mg Revacept
15943745|NCT03312855|Drug|Placebo|single dose, intravenous application of Placebo solution
15943746|NCT03312842|Drug|CS1001|"In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme.
~In the dose expansion part, patients will be assigned to different groups based on their tumor type."
15943747|NCT03312816|Other|cookies enriched with POP|Cookies
15943748|NCT03312803|Procedure|Mini autogenous skin graft|mini-autogenous skin grafts and skin homograft versus autogenous skin grafts for covering post burn wounds in children.
15943749|NCT03312790|Device|Tasks|Augmented reality device Real condition
15943750|NCT03312777|Drug|Omnitram|Omnitram tablets overencapsulated
15943751|NCT03312777|Drug|Tramadol|Tramadol tablet overencapsulated
15943752|NCT03312777|Drug|Placebo|Microcrystalline powder overencapsulated
15943753|NCT03312764|Behavioral|Online diabetes prevention program|Digital delivery of Intensive behavioral counseling for diabetes prevention and healthy lifestyle management. Recipients have access to online curriculum, a live health coach, group-based communication forums, and connected technology to track weight and physical activity.
15943754|NCT03312764|Behavioral|Standard Care|One-on-one or small group sessions with a dietitian or a trained health professional to advise on physical activity, healthful nutrition and risk reduction for diabetes.
15943755|NCT03312751|Drug|Emapalumab|Emapalumab will be administered by intravenous infusion, twice weekly.
15943756|NCT03312738|Drug|Everolimus|Everolimus was formulated as tablets of 5-mg strength and was packaged into blister packs . Everolimus (two 5 mg tablets daily) are administered in a blinded manner on their respective treatment arms by continuous oral daily dosing.
15943757|NCT03312738|Drug|Exemestane|Exemestane 25 mg orally daily.
15943758|NCT03312738|Drug|Everolimus Placebo|Placebo was formulated to be indistinguishable from the everolimus tablets. Matching placebo (two tablets daily) are administered in a blinded manner on their respective treatment arms by continuous oral daily dosing.
15943759|NCT03312725|Device|WEB aneurysm embolization system|The WEB aneurysm embolization system is a class III device and consists of an implantable embolization device attached to a delivery device. The WEB is a mesh composed of single layers of braided nitinol tubes with platinum cores. The braids are held together by proximal and distal platinum/iridium radiopaque markers.
15943760|NCT03312712|Radiation|PET/CT scan|"PET/CT will be performed at Cambridge University Hospital's PET-CT unit, Cambridge.
~Participants in Part A of the study (sarcoidosis and HVs) will receive one PET/CT scan. A Cine-CT scan will be performed immediately prior to the 18F-FDG PET/CT scan. Settings for the CT scans will be determined by clinical protocols, radiation dose will be kept as low as reasonably practicable (ALARP) consistent with UK legislation.
~After 6 hours of fasting and if blood glucose concentration is ≤11mmol/L participants will proceed to undergo an 18FDG PET/CT scan.
~18F-FDG will be administered intravenously at a dose of approximately 200 MBq.
~Positron emission scanning will involve a 60-minute dynamic acquisition from the lungs."
15943761|NCT03312712|Other|LPS Challenge|In Part B, eight healthy volunteers will undergo an LPS challenge whereby each participant is injected with the challenge agent, Lipopolysaccharide (LPS), to invoke temporary mild lung inflammation. Each participant will have a PET/CT scan before and after the administration of LPS and the images will be assessed to determine whether these methods are able to detect true lung inflammation.
15943762|NCT03312712|Other|Saline Challenge|In Part B, four healthy volunteers will undergo a saline challenge as outlined above for the LPS challenge. Pre- and post-challenge scans will provide control data for the study.
15943763|NCT03312712|Diagnostic Test|Blood and urine sampling|For women whose post-menopausal status and/or pregnancy status is uncertain at screening, a blood sample will be collected to test for pregnancy and menopausal status (hormone profiling) before enrolling them on to the study. If pregnancy status is still uncertain at study visits, participants will have a urine pregnancy test before undergoing any PET/CT scans to ensure it is safe for them to continue in the study.
15943764|NCT03312699|Biological|Fluzone® quadrivalent|IIV4 vaccine will be administered as a 0.5 mL dose, with a sterile, disposable syringe and needle by intramuscular (IM) injection into the deltoid muscle.
15943765|NCT03312699|Biological|Fluzone High Dose|High Dose IIV3 vaccine will be administered as a 0.5 mL dose, with a sterile, disposable syringe and needle by IM injection into the deltoid muscle.
15943766|NCT03312699|Biological|Fluad|Fluad vaccine will be administered as a 0.5 mL dose, with a sterile, disposable syringe and needle by IM injection into the deltoid muscle.
15943767|NCT03312699|Biological|Vaqta|Vaqta vaccine will be administered as a 1 mL dose, with a sterile, disposable syringe and needle by IM injection into the deltoid muscle.
15943768|NCT03312699|Biological|Typhim Vi|Typhim Vi vaccine will be administered as a 0.5 mL dose, with a sterile, disposable syringe and needle by IM injection into the deltoid muscle.
15943769|NCT03312699|Biological|Vivotif|One capsule is to be swallowed approximately 1 hour before a meal with a cold or luke-warm [temperature not to exceed body temperature, e.g., 37 °C (98.6 °F)] drink on alternate days, e.g., days 1, 3, 5 and 7.
15943770|NCT03312686|Diagnostic Test|endoflip|Resolution of esophageal eosinophilia by a 2-month course of high dose PPI in patients will lead to improvement in esophageal distensibility, and thus should produce improvement in dysphagia symptoms.
15977356|NCT03056885|Other|Protective One-lung ventilation|Vt 5 ml/kg
15943771|NCT03312673|Other|Interview and tests of drawing.|The intervention will take place with patients followed for asthma at the Croix Rousse hospital. Patients agreeing to participate in the study will come to the hospital for one hour and a half. They will answer questionnaires and tests of drawing. Results Restitution Session (optional) is proposed to patients within the next 4 weeks during a routine consultation.
15943772|NCT03312660|Dietary Supplement|Prebiotic group|Fermented dairy product with galacto-oligosaccharides (GOS), kefiran and other metabolites resulting from the fermentation with kefir granules.
15943773|NCT03312660|Dietary Supplement|Placebo group|Beverage with color, flavor and nutritional composition similar to the fermented dairy product but not containing the prebiotic components.
15943774|NCT03312634|Drug|Palovarotene|Palovarotene will be taken orally once daily at approximately the same time each day following a meal.
15943775|NCT03312621|Behavioral|Health Care Transition Care Coordination|These services included 1) a face-to-face systematic review of the readiness assessment with the participant/caregiver 2) a status assessment of ongoing healthcare transition planning and preparation; 3) monthly phone calls with the participant/caregiver to update and fill gaps in the healthcare transition action plan.
15943776|NCT03312608|Diagnostic Test|Navigated transcranial magnetic stimulation|
15943777|NCT03312595|Device|Restrata TM Wound Matrix|The RestrataTM Wound Matrix is a sterile, single use device intended for use in local management of wounds
15943778|NCT03312582|Drug|1% local metformin gel|After providing manual debridement in deep peri-implant probing depths, 1% metformin gel will be applied.
15943779|NCT03312582|Procedure|Placebo|
15943780|NCT03312569|Procedure|Right Colectomy with Intracorporeal Anastomosis|With the patient under general anesthesia, pneumoperitoneum is achieved by a method of choice of the operating surgeon. Port Placement is completed as per the standard of care. Dissection is performed and the ileocolic vessels are identified. The right mesocolon is mobilized and the ileal mesentery is divided. The transverse colon and ileum are then divided with the stapler. Next, attention is turned to constructing the anastomosis. For this purpose, the terminal ileum and the transverse colon stump are brought together. A colotomy and ileostomy is created to form a common channel. The common enterotomy is then closed as per the surgeon's standard of care. The specimen is extracted through an off-midline incision (muscle splitting transverse incision, Pfannenstiel).
15943781|NCT03312569|Procedure|Right Colectomy with Extracorporeal Anastomosis|With the patient under general anesthesia, pneumoperitoneum is achieved by a method of choice of the operating surgeon. Port Placement is completed as per the standard of care. Dissection is performed and the ileocolic vessels are identified. Intracorporeal devascularization may be performed at the surgeon's discretion. The gastrocolic ligament is taken down and the hepatic flexure is mobilized. After complete mobilization of the right colon, the midline incision is extended to serve as the extraction site. The specimen is delivered through the midline extraction incision and the anastomosis is conducted in a standard open technique. The two cut ends of the bowels are aligned for extracorporeal anastomosis.
15943782|NCT03312556|Device|continuous positive airway pressure (CPAP)|Continuous positive airway pressure(CPAP) will be applied during the night starting from 20:00. CPAP level will be determined during an acute CPAP trial.
15943783|NCT03312556|Drug|Placebo|Placebo pill or patch. Single dose
15943784|NCT03312543|Device|Active Mask|A facial cleanser will be used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF will be applied full-face. For the first 12 weeks of the study, the active light therapy mask will be used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage will be discontinued.
15943785|NCT03312543|Device|Sham Mask|A facial cleanser will be used twice daily (morning and evening). In the morning after washing, the moisturizer with SPF will be applied full-face. For the first 12 weeks of the study, the sham light therapy mask will be used for 10 minutes in the evening after washing/drying the face. For the second 12 weeks of the study, mask usage will be discontinued.
15943786|NCT03312530|Drug|Cobimetinib|Cobimetinib will be administered as per the schedule specified in the respective arm.
15943787|NCT03312530|Drug|Venetoclax|Venetoclax will be administered as per the schedule specified in the respective arm.
15943788|NCT03312530|Drug|Atezolizumab|Atezolizumab will be administered as per the schedule specified in the respective arm.
15943789|NCT03312517|Drug|Suvorexant 10 mg|Subject will receive suvorexant 10mg
15943790|NCT03312517|Drug|Suvorexant 20 mg|Subject will receive suvorexant 20mg
15943791|NCT03312517|Drug|Placebo oral capsule|Subject will receive placebo.
15943792|NCT03312504|Other|Neuromuscular training program|This is a 15-minute warm-up program designed to be implemented at the beginning of junior high school physical education classes. This warm-up is comprised of 15 components; nine of which are aerobic exercises (forward running, forward run with skipping, forward run with knee lifts, forward run with heel kicks, sideways shuffles, zigzag running, forward running with intermittent stops, speed runs, and squat/skate jumps), and six of which are balance/strengthening exercises (front plank, side plank, nordic hamstring exercise, lunges, balancing on the wobble board, and balancing on foam balance pads).
15943793|NCT03312504|Other|Standard-of-practice Warm-up (Control)|This is a 15-minute warm-up program designed to be implemented at the beginning of junior high school physical education classes. This warm-up is comprised of 16 components; seven of which are aerobic exercises (forward running, forward running with arm swings, side shuffling, lunging, skipping, arm running with arm swings, and cool-down running), and nine of which are static stretching exercises (standing quadriceps, standing hamstrings, standing calf, standing groin, rotating ankle, lunges, standing shoulder, standing triceps, standing neck).
15943794|NCT03312478|Drug|Blood draw for insulin auto-anti body tests*|"Pharmaceutical form: N/A
~Route of administration: N/A"
15943795|NCT03312465|Device|AS Domelock System|Hemi or Total Shoulder Arthroplasty
15943796|NCT03312452|Device|Hospira plum pump|The Hospira plum pump enables the clinician to program a specific volume of intravenous fluid and define a period of time over which to administer this fluid.
15943797|NCT03312452|Device|Gravity drip device|Study subjects assigned to this group will receive intravenous fluid via a gravity drip device during their surgery.
15943798|NCT03312439|Behavioral|Given advice|Based on results of testing the participants will be give advice with the general aim to decrease the future risk of non-communicable disease by increasing physical activity,
15943799|NCT03312426|Drug|BMS-986205|Single dose, 100 mg administered at Day 1 and at Day 15.
15943802|NCT03312413|Drug|Dexmedetomidine Hydrochloride|Dexmedetomidine Hydrochloride 0.5 μg·kg-1·h-1 will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery
15943803|NCT03312413|Drug|Dexmedetomidine Hydrochloride|Dexmedetomidine Hydrochloride 0.7 μg·kg-1·h-1 will be administered to participants by intravenous infusion from incision to 20-30 minutes before the end of surgery
15943804|NCT03312400|Drug|Danazol|"Adult: 200 mg daily versus 400 mg daily.
~Pediatric: 4 mg/kg/day divided in twice daily dose (max 400 mg daily) for 6 months or 2 mg/kg/day divided in twice daily dose (max 200 mg daily) for 6 months."
15943805|NCT03312387|Other|Exercise|Aerobic exercise performed 3/d per week during intervention
15943806|NCT03312387|Dietary Supplement|Essential Amino Acids|Mixture of 10g of essential amino acids ingested throughout intervention
15943807|NCT03312387|Dietary Supplement|Placebo|10g of maltodextrin ingested throughout intervention
15943808|NCT03312361|Drug|15% oxygen|Participants will inhale 15% oxygen for 2 hours to see how it affects them.
15943809|NCT03312348|Device|Infrared imaging|Infrared image image acquisition of study participants
15943810|NCT03312335|Drug|Low-dose Aldesleukin (Proleukin®)|Subcutaneous injection of 1.5 million international units (MIU) of Aldesleukin (Proleukin®, Interleukin-2) once daily in 5-day courses every three weeks for a total of 4 cycles.
15943811|NCT03312322|Other|High-frequency transcutaneous electrical nerve stimulation|"4 self adhesive surface electrodes are positioned by pair at the L3-L4 level, laterally.
~Stimulation is setted at rest, 10min before constant workload testing. During this period, intensity is increased every 3minutes to the maximum tolerated by the patient (pain threshold). Thereafter, intensity is not increased anymore during the test.
~It is explained to the patient that he might or no experience the electrical stimulation sensation.
~Current characteristics : 100Hertz, 100ms, bidirectional. Constant workload testing : 60-70rpm ; 75% Wpic ; up to exhaustion or rpm < 60 during more than 10s."
15943812|NCT03312322|Other|Low-frequency transcutaneous electrical nerve stimulation|"4 self adhesive surface electrodes are positioned by pair at the L3-L4 level, laterally.
~Stimulation is setted at rest, 10min before constant workload testing. During this period, intensity is increased every 3minutes to the maximum tolerated by the patient (pain threshold). Thereafter, intensity is not increased anymore during the test.
~It is explained to the patient that he might or no experience the electrical stimulation sensation.
~Current characteristics : 4Hertz, 100ms, bidirectional. Constant workload testing : 60-70rpm ; 75% Wpic ; up to exhaustion or rpm < 60 during more than 10s."
15943813|NCT03312322|Other|Sham transcutaneous electrical nerve stimulation|The procedure is the same as high-frequency transcutaneous electrical stimulation but intensity is progressively setted back to 1mA (over a 45sec period) after every increment so that constant workload testing is performed with 1mA.
15943814|NCT03312309|Procedure|personal embryo transfer|"According to the histological dating of endometrium of natural/hormone replacement cycle in control group, to explore the effectiveness of intervention by advanced or delayed personal embryo transfer .
~The establishment of standard control group: Frozen embryo transfer patients according to the inclusion and exclusion criteria were evaluated for histological dating by endometrial biopsy on 7 days after ovulation/P+7. After routine time transfer in the frozen embryo transfer cycle, the standard of histological dating were determined according to the pregnancy outcome of the FET cycle .
~pET in RIF patients was delayed one(ovulation +4/P+4, OV/P+4) / two days(OV/P+3) or advanced one day(OV/P+9). Day 5 blastocysts were transferred with this strategy in natural cycles."
15943815|NCT03312283|Drug|lucentis|intravitreal injection of 0.5 mg (0.05 ml), Q4W, continuous administration for 3 times (D1, D29, D57)
15943816|NCT03312283|Drug|QL1205|intravitreal injection of 0.5 mg (0.05 ml), Q4W, continuous administration for 3 times (D1, D29, D57)
15943817|NCT03312270|Behavioral|Multimodality information comprehension|Evaluate various aspects of multimodality presentation of materials through text-to-speech systems used by people with aphasia.
15943818|NCT03312257|Combination Product|Multifocal D +2.50 add & 0.01% atropine|Biofinity Multifocal D +2.50 add is a monthly disposable contact lens commercially available from CooperVision; 0.01% atropine is low-dose atropine compounded by local pharmacy.
15943819|NCT03312244|Drug|Pyridostigmine Bromide|Pyridostigmine 180mg/day p.o.
15943820|NCT03312244|Drug|Placebo|Placebo
15943821|NCT03312231|Drug|AS03|Oil-in-water emulsion based adjuvant system.
15943822|NCT03312231|Biological|Inactivated influenza H7N9 vaccine|Monovalent 2017 H7N9 inactivated influenza vaccine
15943823|NCT03312231|Other|Phosphate Buffered Saline (PBS) diluent|Diluent for 2017 Monovalent Inactivated Influenza A/H7N9 virus vaccine (2017 H7N9 IIV)
15943824|NCT03312218|Behavioral|Spaced educational intervention|A spaced educational intervention will be provided to participants
15943825|NCT03312205|Biological|Autologous CAR-T cells|Patients will be drawn 50-100 ml blood to obtain enough peripheral blood mononuclear cells (PBMC) for CAR-T manufacturing. The T cells will be purified from the PBMC, transduced with CAR lentiviral vector, expanded in vitro and then frozen for future administration. Chemotherapy will then be given. Following tumor burden reassessment, CAR-T cells will be infused.
15943826|NCT03312192|Device|Interbody Cage|Anterior cervical discectomy and fusion with interbody cage placement
15943827|NCT03312192|Device|Interbody Cage and Anterior Plating|Anterior cervical discectomy and fusion with interbody cage placement and anterior plating
15943828|NCT03312179|Device|PCI and DES stenting|Percutaneous coronary intervention (PCI) and direct stenting (DES) of culprit lesion vessel.
15943829|NCT03312179|Drug|Incretins|Patients treated before study enrollment by incretin drugs (6 months drugs exposure)
15943830|NCT03312166|Device|Compression device|"interventions on patient are :
~surgical excision of ear lobe keloid
~application of compression device on sutured skin"
15943831|NCT03312153|Drug|Neem|A natural irrigant solution act as anti-inflammatory and anti bacterial
15943832|NCT03312153|Drug|2.5% sodium hypochlorite|anti bacterial root canal irrigant solution
15943833|NCT03312140|Drug|Choline Chloride|
15943834|NCT03312127|Device|ILIAC ENDOPROSTHESIS GORE EXCLUDER|Set up of GORE ® Excluder Iliac Branch Endoprosthesis in endovascular barring of complex aneurysms without distal neck. In the immediate post-operating follow-up visit and at the 3 months visit and the 12 months visit after surgery, an ultra-sound scan, a tomodensitometric exam and a walking test on a treadmill with oximetric gluteal region exploration will systematically be performed.
15980062|NCT03036293|Drug|Placebo|Tablet for oral use.
15943836|NCT03312101|Other|exercise program|functional exercises consisting of a therapeutic exercise program based on concentric strengthening the gluteal muscles (maximus, medius and minimus) , the tensor fasciae latae muscle and the pyramidal muscle; ischiotibial muscle stretching ; and empowerment in eccentric and stretching of the gastrocnemius muscle, soleus muscle, tibialis posterior muscle and flexor of the big toe muscle,
15943837|NCT03312088|Device|Freedom Knee PCK Components|Total Knee Revision
15943838|NCT03312075|Other|Sputum and blood samples|The cystic fibrosis patient will have a first series of sputum as well as a blood sample. On the same day of consultation, a second expectoration will be performed as far as possible.
15943839|NCT03312062|Other|Foam Rolling Exercise|Foam rolling exercise will be performed actively. Participants will use a foam roller for exercise. They will position the foam roller on the chair. Afterwards, they will use their body weights to rub the elbow area (biceps brachii muscle) with this foam. There will be 2 sets and each set will be 1 minute. Single set contains 10 repetitions in 1 minute with 30 seconds resting period between sets.
15943840|NCT03312036|Device|Coupled plasma filtration and adsorption (CPFA)|"Patients affected by acute or acute on chronic liver failure are enrolled to undergo CPFA extracorporeal treatments and the standard medical therapy to recover their basal liver function or as a bridge to liver transplantation"
15943841|NCT03312023|Drug|Ledipasvir 90 MG / Sofosbuvir 400 MG Oral Tablet [Harvoni]|1 pill once daily for 12 weeks for Group A
15943842|NCT03312023|Drug|Sofosbuvir 400 MG [Sovaldi]|1 pill once daily for 12 weeks for Group C
15943843|NCT03312023|Drug|Ledipasvir 90 MG|1 pill once daily for 12 weeks for Group D
15943844|NCT03312010|Device|Spinal Cord Stimulator HF|A needle and catheter is carefully inserted near your spinal column. The stimulator is then placed through the catheter close to your spinal column. The proximal end of the stimulator is then sutured underneath the skin of your back to the fascia to prevent migration.
15943845|NCT03312010|Device|Spinal Cord Stimulator Sham|A needle and catheter is carefully inserted near your spinal column. The stimulator is then placed through the catheter close to your spinal column. The proximal end of the stimulator is then sutured underneath the skin of your back to the fascia to prevent migration.
15943846|NCT03311997|Procedure|Surgical reattachment of hamstring tendons|operatively reattachment of the tendons using suture anchor
15943847|NCT03311984|Diagnostic Test|anti Xa level|monitoring the anti-Xa level according to LMWH emploing
15943848|NCT03311971|Device|Virtual reality glasses|Patients will be treated with virtual glasses
15943849|NCT03311971|Device|No VR glasses|Patients will not use VR glasses
15943850|NCT03311958|Drug|Nivolumab, IV, 240 mg|Patients would be given an infusion of 240 mg nivolumab over 30 min
15943851|NCT03311945|Drug|Raltegravir|Raltegravir (1200 mg QD)
15943852|NCT03311945|Drug|Lamivudine|Lamivudine (300 mg QD)
15943853|NCT03311932|Drug|Infacort®|Immediate release multiparticulate formulation (granules) of hydrocortisone
15943854|NCT03311932|Drug|Cortef®|Immediate release hydrocortisone tablets
15943855|NCT03311906|Drug|0.8% Hyaluronic Acid|Application of 0.8% hyaluronic acid after scaling and root planing
15943856|NCT03311906|Procedure|Scaling and Root Planing|Scaling of the teeth using hand and ultrasonic scalers followed by planing of the root with curettes
15943857|NCT03311893|Procedure|natural orifice surgery|evaluation of the awareness of the use of transvaginal, transoral and transcranial approach in surgical excision and the difference between the health staff and the pathology
15943858|NCT03311880|Behavioral|Cognitive remediation|Participants will be taught compensatory strategies for subjective cognitive impairment in addition to learning about lifestyle modifications that are known to be beneficial on cognition.
15943859|NCT03311867|Other|Ethibond Suture|Cerclage placement with ethibond
15943860|NCT03311867|Other|Prolene Suture|Cerclage placement with prolene
15943861|NCT03311854|Drug|Emapalumab|Emapalumab will be administered at the initial dose of 6 mg/kg by intravenous infusion. Emapalumab treatment will be continued at the dose of 3 mg/kg, every 3 days until study day 15, and then twice-a-week for an additional 2 weeks, i.e. until study day 28.
15943862|NCT03311841|Drug|Midazolam oral solution|Midazolam hydrochloride 10 μg (1 mL of 10 μg/mL oral solution), administered orally as part of a microdose cocktail
15943863|NCT03311841|Drug|Dabigatran and pitavastatin oral solution|375/10 μg dabigatran etexilate and pitavastatin (1 mL of 375/10 μg/mL oral solution), administered orally as part of a microdose cocktail
15943864|NCT03311841|Drug|Atorvastatin and rosuvastatin oral solution|100/50 μg atorvastatin and rosuvastatin (2 mL of 50/25 μg/mL oral solution), administered orally as part of a microdose cocktail
15943865|NCT03311841|Drug|Rifampin|Rifampin 600 mg single dose (two 300 mg capsules) administered orally
15943866|NCT03311828|Biological|Daratumumab|Given IV
15943867|NCT03311828|Drug|Imaging Agent|Given Copper 64Cu-DOTA-daratumumab IV
15943868|NCT03311828|Procedure|Positron Emission Tomography|Undergo PET
15943869|NCT03311828|Other|Pharmacological Study|Correlative studies
15943870|NCT03311815|Diagnostic Test|NGS techniques|Using NGS techniques we will detect the recurrently mutated genes in AML to establish the biological role of each mutation
15943871|NCT03311789|Drug|PD-1 inhibitor + Gemcitabine + Cisplatin|Gemcitabine: 1000mg/m2 on day 1 and 5 every 3 weeks. Cisplatin: 75mg/m2 on day 1 every 3 weeks. PD-1 inhibitor: Nivolumab 3mg/kg, or SHR-1210 200mg.
15943872|NCT03311763|Behavioral|EIM Fitness Practitioners|Exercise is Medicine Practitioners will facilitate peer groups that attend twice-weekly exercise classes for 8 weeks, with clinical monitoring and advise regarding increasing physical activity.
15943873|NCT03311763|Behavioral|Counseling and wearable device|Brief exercise counseling session and provision of a wearable fitness tracking device to promote physical activity.
15943874|NCT03311750|Drug|Panitumumab|6 mg/Kg will be administered intravenous over 1 hour on Day 1 every 2 weeks or 9 mg/Kg every 3 weeks.
15943875|NCT03311737|Combination Product|general anesthesia|The investigators used general anesthesia preoperatively in uniportal VATS lung surgery
15943876|NCT03311737|Combination Product|epidural anesthesia|The investigators used general anesthesia combined with epidural anesthesia preoperatively in uniportal VATS lung surgery
15943877|NCT03311724|Drug|Tirzepatide|Administered SC
15943878|NCT03311724|Drug|Placebo|Administered SC
15943979|NCT03310957|Drug|ladiratuzumab vedotin|Into the vein (IV; intravenously)
15943879|NCT03311711|Behavioral|SPIRIT-in person|The SPIRIT-in person intervention adapted for dementia will include one session and will be conducted in a private room at the clinic. SPIRIT is a structured psychoeducational intervention, targeting both patient and surrogate. The SPIRIT intervention assists patients in clarifying their end-of-life preferences and helps surrogates understand the patient's wishes and prepare for the surrogate role. The intervention is expected to last 45-60 minutes.
15943880|NCT03311711|Behavioral|SPIRIT-remote|The SPIRIT-remote intervention adapted for dementia will include one session and will be conducted through teleconference. SPIRIT is a structured psychoeducational intervention, targeting both patient and surrogate. The SPIRIT intervention assists patients in clarifying their end-of-life preferences and helps surrogates understand the patient's wishes and prepare for the surrogate role. The intervention is expected to last 45-60 minutes.
15943881|NCT03311711|Behavioral|Usual care|Participants will receive the usual care that is provided through the clinic they receive care through. This may include completing advanced directives, referral to a support group, or referral to a social worker for further discussion about end of life issues.
15943882|NCT03311698|Behavioral|Nutrition-sensitive intervention|Nutrition-sensitive intervention using behavior change communication on home gardening, diet, nutrition, WASH, and women's empowerment.
15943883|NCT03311685|Device|vaginal tactile imager|Patients will undergo elasticity assessment with vaginal tactile imaging the be once before surgical repair and twice after surgery in a 3 month interval.
15943884|NCT03311672|Drug|[18F]F-Ara-G|Administered after two cycles of immunotherapy +/- stereotactic radiation therapy as part of the PET/CT scan.
15943885|NCT03311672|Drug|Pembrolizumab|All study participants will receive pembrolizumab every 3 weeks, for 2 cycles.
15943886|NCT03311672|Radiation|PET/CT scan|Scan will be done after two cycles of immunotherapy +/- stereotactic radiation therapy.
15943887|NCT03311659|Biological|Boostrix|One dose administered intramuscularly in the deltoid muscle of the non-dominant arm in dTap group.
15943888|NCT03311646|Other|Normal nicotine content cigarettes (NNC, Baseline)|Participants will exclusively smoke research cigarettes that have a normal nicotine content for five days/four nights while staying in a hotel.
15943889|NCT03311646|Other|Very low nicotine content (VLNC)|Participants will exclusively smoke research cigarettes that have a very low nicotine content for five days/four nights while staying in a hotel.
15943890|NCT03311633|Procedure|Percutaneous pinning time|Percutaneous pinning time will be compared in two groups: 3 versus 6 weeks.
15943891|NCT03311620|Procedure|Endobronchial ultrasound (EBUS) transbronchial needle aspirate (TBNA)|Biopsy samples will be collected from patients scheduled to undergo EBUS TBNA using 19g and 22g needles
15943892|NCT03311607|Drug|AmBisome|A total dose of 15 mg/kg AmBisome given in doses of 3 mg/kg in a biweekly dosing schedule
15943893|NCT03311594|Drug|Low Alcohol|Low Alcohol Consumption
15943894|NCT03311594|Drug|Moderate Alcohol|Moderate Alcohol Consumption
15943895|NCT03311594|Drug|Placebo Alcohol|Placebo Alcohol Consumption
15943896|NCT03311594|Other|Pain Induction|10% capsaicin solution placed on forearm and heat induction
15943897|NCT03311594|Other|No Pain Induction|Water placed on forearm
15943898|NCT03311581|Drug|Propofol|Propofol works by increasing GABA-mediated inhibitory tone in the CNS. Propofol decreases the rate of dissociation of the GABA from the receptor, thereby increasing the duration of the GABA-activated opening of the chloride channel with resulting hyperpolarization of cell membranes.
15943899|NCT03311581|Device|Sevoflurane|sevoflurane inhalation 2~4%
15943900|NCT03311568|Device|ultrasound for microcirculatory assessment|"Ultrasound for microcirculatory assessment Repeated measurements within study participants for analysis of variance and explorative analyses of ultrasound signals, to identify most suitable parameters to describe microcirculatory alterations in critical disease, especially in sepsis.
~Analyse blood flow velocities in several depths and from several vessels of different sizes simultaneously
~US registration repeated within each study participant consecutively on seven different regions of the body surface."
15943905|NCT03311542|Biological|pembrolizumab|Each participant will receive pembrolizumab every 21 days for up to 12 month or until confirmed disease progression on MRI or CT, unacceptable toxicity, confirmed.positive pregnancy test or withdrawal of consent.
15943906|NCT03311529|Behavioral|Applied Relaxation|10 training sessions (90 min. each) in Applied Relaxation (group format)
15943907|NCT03311516|Other|New functional insulin therapy|the patient receives the dietary devices and the instructions for the adaptation of the insulin bolus dose according to a new FIT
15943908|NCT03311516|Other|functional insulin therapy|the patient receives the dietary devices and the instructions for the adaptation of the insulin bolus dose according to FIT
15943909|NCT03311503|Biological|autologous CD34+ cell transduced with G2SCID vector|single infusion of autologous CD34+ cells transduced with the self-inactivating (SIN) lentiviral vector G2SCID
15943947|NCT03311230|Behavioral|Supportive social incentive|A family member or friend will be used as a support person in this study, to receive updates and support the participant in their progress.
15943948|NCT03311230|Behavioral|Competitive social incentive|Participants in this intervention will be competing against each other in the game.
15943949|NCT03311230|Behavioral|Collaborative social incentive|Participants in this intervention will be working with each other in the game.
15943950|NCT03311217|Behavioral|Healthy retail strategies|
15943980|NCT03310957|Drug|Pembrolizumab|IV infusion every 3 weeks
15943910|NCT03311490|Device|Spraino|"Participants allocated to the intervention group will use Spraino® as a measure to prevent future lateral ankle sprains during all on-court practice sessions and matches. Spraino® is an adhesive polytetrafluoroethylene (PTFE or Teflon) patch. It is developed with the intent of minimizing lateral shoe- surface friction whenever initial contact is carried out in an inverted position of the ankle joint. Each Spraino® PTFE patch has a minimum durability of 20 hours use and will be provided by the trial sponsor, Spraino® ApS. The participants allocated to the intervention group will receive four pairs of the Spraino® patches via postal service or by hand delivery on a monthly basis, or upon request if material is worn out prematurely during the 52-week trial period."
15943911|NCT03311477|Drug|ABBV-399|Intravenous infusion
15943912|NCT03311464|Drug|adalimumab|Study drug will be administered subcutaneously.
15943913|NCT03311451|Device|C2 CryoBalloon 180° Ablation System|The C2 CryoBalloon 180° Ablation System is a cryosurgical device with a nitrous oxide cooled balloon probe that is compatible with upper gastrointestinal therapeutic endoscopes.
15943914|NCT03311438|Other|Oral health intervention program|Intervention: All parents were encouraged to brush their children's teeth twice a day, with adjusted amount of fluoride toothpaste according to age. Additional fluoride tablets with dose according to age were recommended from two years of age. The children's parents were given written information about the importance and benefits of optimal oral hygiene and explaining the link to infective endocarditis. A pamphlet, lift the lip program, with instruction of looking for early signs of tooth decay, how to intervene and contact local Public Dental Service (PDS) clinic. Dietary advice was also given. The child's responsible dentist or dental hygienist at the local PDS was contacted with information about the project and the findings from examination.
15943915|NCT03311425|Drug|Methylprednisolone|Application of 40mg Depomedrol (methylprednisolone acetate) suspension into the retropharyngeal space prior to incision closure
15943916|NCT03311425|Drug|Dexamethasone|Administration of 10mg Dexamethasone IV intraoperatively
15943917|NCT03311412|Drug|Sym021|Sym021 is a humanized antibody that binds PD-1 with sub-nanomolar affinity and blocks binding of the inhibitory ligands PD-L1 and PD-L2, thus releasing PD-1-mediated inhibition of the immune response.
15943918|NCT03311412|Drug|Sym022|Sym022 is a recombinant, fully human antibody that binds LAG-3 and blocks the LAG-3/major histocompatibility complex class II (MHC-II) interaction, thus allowing for increased T-cell proliferation and cytokine production.
15943919|NCT03311412|Drug|Sym023|Sym023 is a recombinant, fully human antibody that binds TIM-3 and induces activation of immune cells.
15943920|NCT03311399|Other|SSI Screening Tool used in home visits by CHWs|Individuals in Arm 1 will be visited at home by the sCHW who will administer the optimized SSI protocol via the mHealth device. Following the screening, the sCHWs will use the cell phone to photograph the surgical wound and record the GPS location of the visit.
15943921|NCT03311399|Other|SSI Screening Tool used via phone call follow-up|Individuals in Arm 2 will be phoned by the sCHW who will administer the SSI protocol over the phone.
15943922|NCT03311386|Drug|Actilyse|thrombolytic therapy
15943923|NCT03311373|Drug|Regimen A|2 inhalations BGF MDI; no spacer device; no oral charcoal - reference formulation/total systemic exposure
15943924|NCT03311373|Drug|Regimen B|2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; no oral charcoal - test formulation/total systemic exposure
15943925|NCT03311373|Drug|Regimen C|2 inhalations BGF MDI; no spacer device; with oral charcoal - reference formulation/lung exposure
15943926|NCT03311373|Drug|Regimen D|2 inhalations BGF MDI; AeroChamber Plus Flow-Vu spacer device; with oral charcoal - test formulation/lung exposure
15943927|NCT03311360|Device|drug-coated balloon|Orchid and Dahlia DCB
15943928|NCT03311360|Device|bare metal stent|any type of bare metal stent
15943929|NCT03311347|Other|+Gz accelerations and positive pressure breathing|
15943930|NCT03311334|Drug|DSP-7888 Dosing Emulsion|DSP-7888 Dosing Emulsion will be administered intradermally (ID) every 7 days until cycle 3, and then every 14 days for combination with Nivolumab arm or every 21 days for combination with Pembrolizumab arm.
15943931|NCT03311334|Drug|Nivolumab|Nivolumab will be administered in the approved dose and schedule starting on Day 29 of the study.
15943932|NCT03311334|Drug|Pembrolizumab|Pembrolizumab will be administered in the approved dose and schedule starting on Day 22 of the study.
15943933|NCT03311321|Dietary Supplement|Vitamin K2 (menaquinone-7; 360-mcg/d)|four 90-mcg vitamin K2 (menaquinone-7) softgel capsules per day for 8 weeks
15943934|NCT03311321|Dietary Supplement|Placebo-Control|four placebo softgel capsules per day for 8 weeks containing no vitamin K2 (menaquinone-7)
15943935|NCT03311308|Drug|Pembrolizumab Injection [Keytruda]|200mg, IV, every three weeks, up to two years; After the first three doses, dosing can be changed to 400mg IV every 6 weeks, at the treating physician's discretion.
15943936|NCT03311308|Drug|Metformin|500 mg, by mouth, twice a day for nine weeks.
15943937|NCT03311295|Device|ARTO System|The ARTO System directly reshapes the mitral annulus promoting leaflet coaptation and amelioration of regurgitation.
15943938|NCT03311282|Device|infants bottles|"angled/inclined teat that remains full of milk throughout the feeding to prevent the risk of air ingestion, gassy colic, hiccups and regurgitation and to keep the infant's neck in the right position;
~extra-large, soft and rounded base to ensure maximum simulation of the maternal breast and a wide latch on for a correct suckling motion
~flexors at the base to enhance elasticity and flexibility of the teat"
15943939|NCT03311282|Device|Infants Bottles|"large, rounded and soft teat to ensure maximum simulation of the maternal breast and a wide latch on for a correct suckling motion
~non-inclined shape of the teat ideal from 4 months onwards, when the colic episodes have subsided and infant has more control of the neck.
~flexors at the base to enhance elasticity and flexibility of the teat"
15943940|NCT03311282|Device|Infants Bottles|"teat with less rounded base to guarantee tighter lip support, which helps the sucking motion.
~flexors at the base to enhance elasticity and flexibility of the teat"
15943941|NCT03311269|Device|ClariVein RES|ClariVein system
15943942|NCT03311269|Drug|Sodium Tetradecyl Sulfate 1% Injection|Sodium Tetradecyl Sulfate STS 1% Injection
15943943|NCT03311269|Drug|Sodium Tetradecyl Sulfate 3% Injection|Sodium Tetradecyl Sulfate 3% Injection
15943944|NCT03311256|Diagnostic Test|Tissue Transit Time|Determination of Tissue Transit Time as a prognostic and diagnostic factor
15943945|NCT03311243|Procedure|Non surgical periodontal therapy|
15943951|NCT03311204|Device|BlephEx|BlephEx is an instrument that contains a hand piece used to spin a medical grade micro-sponge along the edge of eyelids and lashes that helps in removing scurf and debris from eyelids and helps in exfoliating the lids. A new micro-sponge will be used for every subject to avoid cross-contamination. This procedure lasts for 6-8 mins.
15943952|NCT03311204|Other|Lid Hygenix|Foam-based hypoallergenic cleanser used to clean eyelid margins is used as a control intervention for the study.
15943953|NCT03311191|Device|Measurement of skin oxygenation and oxygen consumption|Oxygenation properties will be measured using a transparent paint-on bandage formulation that consists of New-Skin liquid bandage, an oxygen-sensing metallo-porphyrin exhibiting bright red phosphorescence, and the green-fluorescing reference dye fluorescein.
15943954|NCT03311178|Drug|Dobutamine|Infants who meet the definition of poor perfusion state will be treated at the discretion of the responsible physician following the standard local policies. The interventions will be dobutamine from a new neonatal formulation developed for NeoCirc and/or other treatments (including any other cardiovascular drug or volume replacement with normal saline).
15943955|NCT03311165|Other|no intervention|no intervention was given
15943956|NCT03311152|Diagnostic Test|"Epi proColon 2.0 CE test from Epigenomics, Inc (Berlin, Germany)"|The mSEPT9 assay consists of DNA extraction from plasma, bisulfite conversion of DNA, purification of bis-DNA, and real-time PCR.
15943957|NCT03311139|Drug|Antithrombotic agents|Antiplatelets and anticoagulants purchased 4 months before and within 7 days after the index date
15943958|NCT03311126|Drug|Bendamustine|Bendamustine is a chemotherapeutic agent that has dual functional properties of both an alkylating agent and a nitrogen mustard. Through these unique cytostatic properties, bendamustine is able to inhibit DNA transcription, replication, and repair. Bendamustine is approved in the U.S. for treatment of CLL and for indolent B cell NHLs progressing during or within 6 months of rituximab or a rituximab - containing regimen.
15943959|NCT03311126|Drug|Obinutuzumab|Obinutuzumab is a glycoengineered, humanized, type II anti-CD20 mAb.
15943960|NCT03311113|Other|Drug adherence questionnaire|Adherence to oral antibiotic therapy will be assessed by means of a questionnaire adapted from the French standardized self-assessment questionnaire of Girerd et al. This questionnaire has six questions, each question being associated with a score. Patient's drug adherence is classified into three groups based on the total score: of high, moderate and poor adherence. The questionnaire will be carried by a phone call to the patient.
15943961|NCT03311100|Other|immunohistochemistry assay|biomarkers expression
15943962|NCT03311074|Biological|Strimvelis|Strimvelis is a gene therapy that aims to restore ADA function in hematopoietic cell lineages and prevent the immunological manifestations. Strimvelis is a cluster of differentiation (CD) 34+ cell enriched dispersion of human bone marrow derived hematopoietic stem cells for infusion which have been transduced with a retroviral vector containing the human ADA gene.
15943963|NCT03311061|Other|DREAMS Curriculum|Teen Pregnancy Prevention Curriculum as described in arm/group description.
15943964|NCT03311048|Other|Nasal swab|Nasal swab was collect to upper airways inflammation evaluation.
15943965|NCT03311048|Other|Questionnaires|Clinical profile and respiratory symptoms employees' evaluation were performed using specific questionnaires (European Community Respiratory Health Survey for occupational diseases evaluation (ECRHS), (adapted by Ribeiro et al, 2007) and the International Study of Asthma and Allergies in Childhood (ISAAC) - Asthma module, previously translated and validated.
15943966|NCT03311035|Procedure|Seton|The identification of the primary tract of the fistula and the placement of the thread can be performed in one single step. a non-absorbable, braided thread is inserted . After excision of the external opening and the extrasphincteric parts of the fistula, the thread is grasped and is pulled out of the anus .The thread is cut in two parts. The mucosa is incised over the muscular bridge . One thread is tied snugly around the muscle; the other is tied loosely .The snugly tied seton has to be replaced after 14 days to provide appropriate tension to cut slowly trough the muscle. This can easily be achieved with the second loosely tied seton . A new thread is folded in the middle and connected to the opened sling of the loose seton using a special knot shown in.The old thread is removed and in the same maneuver two new setons are placed. Again, one thread is tied snugly around the remaining portion of the sphincter muscle; the other is tied loosely .
15943967|NCT03311035|Procedure|LIFT technique|The internal opening was identified . The intersphincteric plane was entered via a curvilinear incision corresponding to the site of the internal opening at the intersphincteric groove. The intersphincteric plane was developed by meticulous scissor and diathermy dissection up to the tract. Once identified, a small, right-angled clamp was hooked underneath or a tape passed round it. the tract was then transfixed close to the internal sphincter with 2/0 polyglactin suture . Saline was gently injected through the external opening to confirm that the tract was no longer patent and it was then divided distal to the point of ligation . After light traction, a segment of the distal tract was excised and, if needed, any defect in the external sphincter was closed. The intersphincteric incision wound was re-approximated loosely with interrupted 2/0 Vicryl. Partial core-out of the fistula tract was performed from the external opening to the external sphincter.
15943968|NCT03311022|Drug|Nefopam Hydrochloride 30mg Tablets|
15943969|NCT03311022|Drug|Acupan® 30mg Tablets|
15943970|NCT03311009|Drug|GLPG1972 cohort 1|GLPG1972 dose 1 provided as oral tablets q.d.
15943971|NCT03311009|Drug|GLPG1972 cohort 2|GLPG1972 dose 2 provided as oral tablets q.d.
15943972|NCT03311009|Drug|GLPG1972 cohort 3|GLPG1972 dose 3 provided as oral tablets q.d.
15943973|NCT03311009|Drug|Placebo|Matching placebo provided as oral tablets q.d.
15943974|NCT03310996|Other|Transcranial direct current stimulation|tDCS is an established research tool for non-invasive modulation of neuroplasticity. It has shown promise as a neurorehabilitation tool and demonstrated positive effects in various clinical conditions such as Alzheimer's, stroke, childhood psychosis, epilepsy and dystonias. tDCS uses low-intensity DC currents to modulate spontaneous neuronal network activity by altering the resting membrane potential.
15943975|NCT03310983|Dietary Supplement|Docosahexaenoic acid|The main study, ADORE, includes providing DHA to participants during pregnancy. No intervention is included as part of this study.
15943976|NCT03310970|Drug|Lidocaine patch 5%|Each subject will wear three Lidocaine patches for 12 hours.
15943977|NCT03310970|Drug|Lidocaine Hydrochloride|Each subject will receive a dose of 0.5 mg/kg intravenously over a period of 5 minutes.
15943978|NCT03310970|Drug|Lidoderm 5 % Topical Patch|Each subject will wear three Lidoderm® patches for 12 hours.
15943981|NCT03310944|Drug|sotagliflozin (SAR439954)|"Pharmaceutical form: tablets
~Route of administration: oral"
15943982|NCT03310918|Other|Palliative Care|Specialized medical care for people with serious illness. This type of care is focused on providing relief from the symptoms and stress of a serious illness. The goal is to improve quality of life for both the patient and the family
15943983|NCT03310918|Other|Standard Leukemia care|Standard care per the hospital guideline
15943984|NCT03310905|Drug|Immunosuppressive Agents|Standard immunosuppression therapy following an isolated abdominal wall transplant.
15943985|NCT03310905|Procedure|Abdominal Wall Transplant|Transplant of abdominal wall alone or in combination with another solid organ transplant.
15943986|NCT03310892|Behavioral|Generic message|Generic message
15943987|NCT03310892|Behavioral|Tailored message|Tailored message
15943988|NCT03310879|Drug|Abemaciclib|Abemaciclib is a cyclin-dependent kinase (CDK) inhibitor. CDK inhibitors work to stop cell growth.
15943989|NCT03310866|Device|fiberoptic, airway|classic fiberoptic bronchoscope, fenstrated airway
15943990|NCT03310866|Device|fiberoptic, Machintosh|oral fiberoptic brochoscopic, Machintosh laryngoscope
15943991|NCT03310853|Dietary Supplement|Probiotic|Dosing regimen of one capsule daily for a maximum of 18 weeks
15943992|NCT03310853|Other|Placebo|Dosing regimen of one capsule daily for a maximum of 18 weeks
15943993|NCT03310840|Other|others|others
15943994|NCT03310827|Behavioral|Personalized Nutrition|Diet plan based on nutrition-related gene test results
15943995|NCT03310814|Other|Personalized nutrition|Receives individualized nutrition information
15943996|NCT03310801|Procedure|ACP or Watchman|Left atrial appnedage occlusion using ACP or Watchman
15943997|NCT03310775|Behavioral|Parent-assisted social skills training program for young adult with ASD|The subjects will participate in the treatment program weekly for a total of 16 weeks. The final visit will be made at the point four months after the completion of treatment to see long-term effects.
15943998|NCT03310762|Other|Alma Sana Bracelet|Every time a child receives a vaccine, vaccinators will hole punchers to perforate shapes denoting the particular vaccine a child has received.
15943999|NCT03310762|Other|Simple Silicon Bracelet|Every time a child receives a vaccine, vaccinators will hole punchers to perforate shapes denoting the particular vaccine a child has received.
15944000|NCT03310749|Drug|Gemigliptin|A 7-day treatment period with gemigliptin 50 mg q.d., followed by a 5-day washout period; a 7 day treatment period with metformin 1000 mg twice a day followed by a 5-day washout period and a final 7-day treatment period with gemigliptin 50 mg q.d. + metformin 1000 mg twice a day
15944001|NCT03310749|Drug|Gemigliptin 50 mg q.d. + metformin 1000 mg twice a day|A 7-day treatment period with gemigliptin 50 mg q.d. + metformin 1000 mg twice a day followed by a 5-day washout period; a 7-day treatment period with gemigliptin 50 mg q.d. followed by a 5-day washout period and a final 7-day treatment period with metformin 1000 mg twice a day
15944002|NCT03310749|Drug|Metformin|A 7-day treatment period with 1000 mg metformin twice a day followed by a 5-day washout period; a 7-day treatment period with gemigliptin 50 mg q.d.+ metformin 1000 mg twice a day followed by a 5-day washout period and a final 7-day treatment period with gemigliptin 50 mg q.d.
15944003|NCT03310736|Diagnostic Test|Intrinsic Hepcidin IDx™ Test|ILS scientists developed the bioanalytical method for quantitation of human serum hepcidin using a Beckman FX automated liquid handling platform. The method uses a competitive ELISA format that has a proprietary sensitive and specific monoclonal antibody to hepcidin that captures native hepcidin in a sample. During the reaction a competition between a synthetic, bioactive, biotinylated hepcidin tracer and native hepcidin occurs. Bound biotinylated tracer is detected with a streptavidin-HRP conjugate and TMB substrate. Quantitation is based on an eight-point standard curve using validated, synthetic hepcidin calibrators. The standard curve and the hepcidin concentrations of patients samples are calculated using 4-parameter logistic curve fitting (Prism; Graphpad, Inc., La Jolla, CA). Serum hepcidin concentrations are expressed in ng/ml serum.
15944004|NCT03310723|Device|Face Mask preoxygenation|Standard face mask preoxygenation.
15944005|NCT03310723|Device|OptiFlow preoxygenation|Preoxygenation using transnasal humidified rapid insufflation ventilatory exchange (THRIVE).
15944006|NCT03310710|Device|Viabahn BX stent|Viabahn BX stent graft used as the branch device with a fenestrated EVAR graft
15944009|NCT03310671|Procedure|Echocardiogram|"Conventional transthoracic echocardiogram by an echocardiographer trained to perform and centered on aortic valve
~Pick up from:
~Mean transvalvular pressure gradient
~Aortic valve
~Aortic valve opening area
~Aortic valve opening area adjusted for body mass index
~Bicuspid or tricuspid aorta
~Thickness of the upper valve> 3 mm"
15944010|NCT03310658|Device|Zip-Stitch Soft Tissue Closure System|The novel Zip-Stitch System employed a laparoscopic applicator, a series of bio-absorbable clips, and an application procedure to close the vaginal cuff during otherwise standard of care total laparoscopic hysterectomy.
15944011|NCT03310645|Drug|BAY1817080|4 different doses over the course of study
15944012|NCT03310645|Drug|Matching Placebo|Matching placebo for BAY
15944013|NCT03310632|Drug|Antroquinonol|Antroquinonol: 100 mg and corn oil 100 mg encapsulated in a gelatin capsule administered orally. Dose will be selected(200mg TID or 300mg TID with SOC) after phase I, then follow up the best dose for 40 Patients for the efficacy.
15944014|NCT03310619|Biological|JCAR017|Gene modified autologous T cells
15944015|NCT03310619|Drug|Durvalumab|Anti-PD-L1
15944016|NCT03310619|Drug|CC-122|Pleiotropic Pathway Modifier
15944017|NCT03310619|Drug|Ibrutinib|Ibrutinib
15944018|NCT03310619|Drug|CC-220|CC-220
15944019|NCT03310619|Drug|Relatlimab|Relatlimab
15944020|NCT03310619|Drug|Nivolumab|Nivolumab
15944021|NCT03310619|Drug|CC-99282|CC-99282
15944097|NCT03310034|Dietary Supplement|Control|Control product containing amino-acid mixture resembling whey-protein not containing the NAD+-precursors nicotinic acid, nicotinamide, and tryptophan. To be taken for 31 days.
15944022|NCT03310606|Other|Dosage of serum and peritoneal of the B lactam used for antibiotic treatment|Dosage of serum and peritoneal of the B lactam used B lactam concerning are : CEFTRIAXONE, CEFOTAXIME, PIPERACILLINE/TAZOBACTAM, IMIPENEM
15944023|NCT03310593|Drug|Cannabidiol|Cannabidiol as active intervention.
15944024|NCT03310593|Drug|Placebo|Placebo intervention.
15944025|NCT03310580|Drug|AR-13324 Ophthalmic Solution 0.02%|Administered to each eye, once daily (QD) in the evening (PM) for 28 days
15944026|NCT03310580|Drug|AR-13324 Ophthalmic Solution 0.04%|Administered to each eye, once daily (QD) in the evening (PM) for 28 days
15944027|NCT03310580|Drug|AR-13324 Ophthalmic Solution Placebo|Administered to each eye, once daily (QD) in the evening (PM) for 28 days
15944028|NCT03310567|Drug|Epacadostat + pembrolizumab|Each patient would be administered epacadostat orally twice a day and pembroluzimab by infusion once in a cycle of 21 days
15944029|NCT03310554|Procedure|26cm suspended overlength biliary stents|The test group will be placed 26cm suspended overlength biliary stents in introhepatic bile duct in ERCP
15944030|NCT03310554|Procedure|30cm suspended overlength biliary stents|The test group will be placed 30cm suspended overlength biliary stents in introhepatic bile duct in ERCP
15944031|NCT03310554|Procedure|ordinary plastic biliary stents|The control group will be placed ordinary plastic biliary stents in bile duct in ERCP
15944032|NCT03310541|Drug|AZD5363|AZD5363 400mg PO twice daily for 4 days on, 3 days off, every week
15944033|NCT03310541|Drug|Enzalutamide|Enzalutamide 160 mg PO once daily
15944034|NCT03310541|Drug|Fulvestrant|500mg IM days 1, 15, 29 (cycle 2 day 1) and then every 4 weeks
15944035|NCT03310528|Behavioral|Interview questionnaire|Complete interview questionnaire regarding the composition and timing of their most recent food intake.
15944036|NCT03310528|Procedure|Gastric ultrasound exam|Gastric ultrasound exam prior to upper GI endoscopy procedure.
15944037|NCT03310515|Behavioral|Risk reduction counseling|Subjects will receive comprehensive prevention package including HIV and safe sex counseling, provision of condoms and water-based lubricant, and STI screening and referral for treatment.
15944038|NCT03310515|Other|Social harm interview|Information regarding social harms (loss of privacy, stigmatization, interference with gainful employment, and coercion) will be solicited during bi-monthly study visits after enrollment in the study and will be recorded. Subjects who report social harms will be referred to speak with a social worker and/or a study counselor.
15944039|NCT03310515|Other|Computer-Assisted Self Interviewing technique|Demographic, behavioral, and psychosocial factors associated with HIV acquisition will be assessed by CASI.
15944040|NCT03310489|Behavioral|Digitalized cognitive-behavioral intervention for anxiety|An internet-based CBT, including telephone coaching
15944041|NCT03310489|Behavioral|Psychoeducation about anxiety|Psychoeducative material about anxiety in internet
15944042|NCT03310476|Other|Potatoes|Participants will follow the same protocol for each arm with a minimum of 1-week wash-out period between arms. For each arm, fasting blood will be collected then 200 g of potato will be consumed. Postprandial blood will be collected 15, 30, 60, and 120 minutes. Subjective satiety will be assessed using Visual Analogue Scale three times, as well as 48-hour subsequent dietary intake.
15944043|NCT03310463|Drug|ETX2514SUL|Single dose of up to 1000 mg ETX2514 and 1000 mg sulbactam given by concurrent 3-hr IV infusion
15944044|NCT03310450|Other|140kms cycling|Main exposure is long distance cycling touring (TdB/NC) consists of three groups; 140kms, 100kms, and 240kms (investigator did not give any treatment/intervention, just observed the cycling touring event)
15944045|NCT03310437|Procedure|Primary PCI|Primary percutaneous coronary intervention in acute myocardial infarction patients
15944046|NCT03310424|Other|No active intervention.|No active intervention is undertaken. Collection of samples for bio-informatic analysis only
15944047|NCT03310411|Drug|Lasmiditan|Administered orally
15944048|NCT03310411|Drug|Sumatriptan|Administered orally
15944049|NCT03310411|Drug|Placebo for Lasmiditan|Administered orally
15944050|NCT03310411|Drug|Placebo for Sumatriptan|Administered orally
15944051|NCT03310398|Behavioral|NeuroImaging|standard anatomical and functional imaging
15944052|NCT03310398|Behavioral|Psychophysiological|Hear rate, Vagal Tone, Skin Conductance, and Startle Reflex Electromyogram
15944053|NCT03310385|Drug|GHX02|Herbal medicine originating from gualouhengryunhwan
15944054|NCT03310385|Drug|Placebo|Placebo tablets
15944055|NCT03310372|Radiation|Ultrafractionated brain irradiation|0.75 Gy a day, 5 times a week, for 6 weeks (total dose: 67.5 Gy)
15944056|NCT03310372|Drug|Temozolomide|75 mg/m2/day, 7 times a week, for 6 weeks (total 42 days)
15944057|NCT03310359|Dietary Supplement|Astaxanthin|The agent to be tested is astaxanthin, isolated from H. pluvialis following GMP standards. A GRAS notice (GRN000294) was accepted by the Food and Drug Administration (FDA) in January 2010. Agent is stored in capsules at room temperature.
15944058|NCT03310359|Other|Placebo|Matching placebo pill
15944059|NCT03310333|Drug|Propess® (dinoprostone)|"The inclusion begins after 12 hours of PROM for a pregnant woman who has an unfavourable cervix and no B streptococcus. The case is discussed during the obstetric staff every morning.
~If the cervix is unfavourable (cervical Bishop's score <6), the information of the study is given to the patient and the consent collected.
~An antibiotic is started at the beginning of the inclusion by amoxicillin (or clindamycin in case of allergy of amoxicillin) to prevent choroamnionitis."
15944060|NCT03310333|Device|cook cervical pipening balloon|• In dinoprostone vaginal group: the device is placed in vaginal fornix by the midwife for maximum 24 hours. If Propess ® is fallen before the first 12 hours, another one could be introduce if the cervix stayed unfavourable.
15944061|NCT03310320|Drug|AZD0284 oral solution 2.5 mg/mL|AZD0284 oral solution 2.5 mg/mL, 100 mg twice daily for for 4 weeks
15944062|NCT03310320|Drug|Placebo|Placebo for AZD0284 oral solution, twice daily for 4 weeks
15944063|NCT03310307|Drug|Vit D|50,000 IU
15944064|NCT03310307|Other|Placebo|
15944065|NCT03310294|Dietary Supplement|Placebo|one bottle of placebo (minidrink fermented with low-fat milk but without Lactobacillus rhamnosus and without FOS, and without viable bacteria 90 grams)per day at breakfast until the end of the study (V5, day 140). At each visit, subjects were dispensed a sufficient amount of minidrinks until the next visit.
15944098|NCT03310021|Biological|Andexanet alfa|fXa inhibitor antidote
15944066|NCT03310294|Dietary Supplement|Prebiotics and Probiotics|one bottle of the study product (minidrink with fermented low-fat milk added with Lactobacillus rhamnosus (Lactobacillus rhamnosus) and fructooligosaccharides (FOS),per day at breakfast until the end of the study (V5, day 140). At each visit, subjects were dispensed a sufficient amount of minidrinks until the next visit.
15944067|NCT03310281|Device|HOLD: Videogame|Videogame-like digital therapy
15944068|NCT03310268|Other|0.454% Stannous fluoride (SnF2) and 0.072% sodium fluoride (NaF): 1450 ppm fluoride in total|Participants will be instructed to apply experimental dentifrice (containing 454% SnF2 and 0.072% NaF, 1450 ppm fluoride in total), covering the full length of toothbrush head (full ribbon) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate.
15944069|NCT03310268|Other|1400 ppm fluoride as sodium monofluorophosphate (SMFP)|Participants will be instructed to apply negative control dentifrice (containing 1400 ppm fluoride as SMFP), covering the full length of toothbrush head (full ribbon) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate.
15944070|NCT03310268|Other|Stannous Chloride (SnCl2) and 0.15% NaF: 1450 ppm fluoride in total|Participants will be instructed to apply positive control dentifrice (containing SnCl2 and 0.15% NaF, 1450 ppm fluoride in total), covering the full length of toothbrush head (full ribbon) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate.
15944071|NCT03310255|Diagnostic Test|H pylori Faecal Antigen|All patients will be screened for H. pylori using fecal Ag and positive patients will do endoscopy and biopsy.
15944072|NCT03310242|Behavioral|Sunlight Exposure|"Everyday sunlight exposure around noon for 20-30 minutes for 8 weeks
~Completing a Sun Diary after sunlight exposure"
15944073|NCT03310242|Dietary Supplement|Vitamin D Supplementation|- Supplementation of vitamin D3 500 IU/day for 8 weeks
15944074|NCT03310242|Other|Placebo|- Intake of placebo for 8 weeks
15944075|NCT03310229|Radiation|plain chest x-ray|the participants will be subjected to plain chest x-ray with other tools to help diagnose pulmonary hypertension in haemodialysis patients
15944076|NCT03310216|Procedure|Order I of visual inspection|Participants in group I are provided AI visual inspection system first and EDTRS later.
15944077|NCT03310216|Procedure|Order II of visual inspection|The participants in Group II are provided EDTRS first and AI visual inspection system later.
15944078|NCT03310203|Diagnostic Test|Iron|Labelled iron
15944079|NCT03310151|Procedure|Imagined movements|Imagined wrist movements, 10-15 minutes, 4 times a day.
15944080|NCT03310138|Device|Real Transcranial Magnetic Stimulation|Transcranial magnetic stimulation (TMS) is a minimally invasive brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a figure-8 coil (lasting only microseconds) is able to focally stimulate the cortex by depolarizing superficial neurons, which induces electrical currents in the brain. TMS pulses that are delivered repetitively and rhythmically are referred to as repetitive TMS (rTMS). In this study TMS is being delivered with the MagVenture MagPro B60 coil.
15944081|NCT03310138|Device|Sham Transcranial Magnetic Stimulation|The MagVenture MagPro system has an integrated active sham that passes current through two surface electrodes placed on the skin beneath the B60 coil.
15944082|NCT03310125|Drug|Colchicine|0.5mg tablet, twice daily for 10 days
15944083|NCT03310125|Drug|Placebo|Placebo oral tablet, twice daily for 10 days
15944084|NCT03310112|Behavioral|4-week MBAT|The training is known as Mindfulness-Based Attention Training, or MBAT. The MBAT program is based on the principles of Mindfulness-Based Stress Reduction, but contextualized for military personnel using themes relevant to military life. The training content is comprised of four central themes: concentration, body awareness, open monitoring, and compassion. This content will be delivered in 4, 2-hour sessions over 4 weeks. Participants will be assigned homework mindfulness practice during the interval of course delivery as well as for the few weeks following the end of the course.
15944085|NCT03310112|Behavioral|2-week MBAT|The training is known as Mindfulness-Based Attention Training, or MBAT. The MBAT program is based on the principles of Mindfulness-Based Stress Reduction, but contextualized for military personnel using themes relevant to military life. The training content is comprised of four central themes: concentration, body awareness, open monitoring, and compassion. This content will be delivered in 4, 2-hour sessions over 2 weeks. Participants will be assigned homework mindfulness practice during the interval of course delivery as well as for the few weeks following the end of the course.
15944086|NCT03310099|Behavioral|Increasing daily unsaturated fatty acid consumption|Investigators will provide participant with detailed information about the consumption of food rich in unsaturated fatty acids (UFA) like extra-virgin olive oil, canola oil or mixed nuts, and they will provide specific recommendations based on the participant's diet. The investigators will follow up with a weekly phone call to assure that the dietary recommendations are clear and that the participants can integrate the suggestions into their daily diets.
15944087|NCT03310086|Device|Traditional fixed appliance|aligning and leveling of lower anterior teeth using traditional fixed appliance.
15944088|NCT03310086|Procedure|Corticision|Corticison, cortical bone incision without flap elevation, will be applied to the lower anterior teeth
15944089|NCT03310073|Biological|bOPV|Batch Number: 2042015
15944090|NCT03310073|Biological|Pentabio|Batch number: 5050115 The vaccine shall be given intramuscularly.
15944091|NCT03310073|Biological|IPV|The vaccine shall be given intramuscularly.
15944092|NCT03310060|Drug|Tisseel|Tisseel® (Fibrin Sealant, 4ml, Baxter) was applied on potential bleeding sites: the femoral insertion of the posterior cruciate ligament, the lateral genicular artery after resection of the meniscus, the posterior capsule of the knee joint, the bony surfaces not covered by the implant as well as the pinholes (femur and tibia). The entire content of a 4 mL vial containing the active product was used
15944093|NCT03310060|Drug|Tranexamic Acid|Drug: Tranexamic acid Intravenous application of tranexamic acid 15mg/kg in 100 ml normal saline before surgical incision and 3 hours after surgery
15944094|NCT03310047|Drug|Infusion, Lidocaine, 0.5%, 5 mL|A catheter-based perineural infusion of 5 mL Lidocaine 0.5%
15944095|NCT03310047|Drug|Infusion, Lidocaine, 0.5%, 10 mL|A catheter-based perineural infusion of 10 mL Lidocaine 0.5%
15944096|NCT03310034|Dietary Supplement|NAD-precursors|Intervention product containing the NAD+-precursors nicotinic acid, nicotinamide, and tryptophan (total of 204 NE per serving) in a whey protein source for 31 days.
15944103|NCT03310008|Biological|NKR-2 cells|The intervention will consist of an infusion of NKR-2 cells administered concurrently to a standard chemotherapy every 2 weeks (14 days) for a total of 3 infusions within 4 weeks (28 days).
15944104|NCT03309995|Device|Lozenges|The participants will be instructed to take 6 lozenges daily over the time awake, evenly distributed, allowing the lozenge to dissolve in the mouth as slowly as possible.
15944105|NCT03309995|Device|Placebo lozenges|Placebo lozenges
15944106|NCT03309982|Dietary Supplement|Plant polyphenol blend|A powder product that will be mixed into a drink and consumed immediately prior to eating a high-fat meal
15944107|NCT03309982|Other|Placebo|A powder product that will be mixed into a drink and consumed immediately prior to eating a high-fat meal
15944108|NCT03309956|Device|Holter Monitor|A Holter monitor is a battery-operated portable device that measures and records your heart's electrical activity (ECG) continuously. Patients in this study will wear the monitor for 48 hours.
15944109|NCT03309956|Device|Zio Patch|The Zio Patch is a small, adhesive, water-resistant single lead electrocardiographic monitoring device. Patients in this study will wear the patch for 48 hours.
15944110|NCT03309943|Drug|Propranolol|Participants will take one dose of Propranolol (40mg IR) on two separate occasions.
15944111|NCT03309943|Drug|Placebo|Participants will take one dose of Placebo on two separate occasions.
15944112|NCT03309930|Behavioral|Comprehension Acquired Brain Injury|For study 1 participants will be exposed to 3 conditions as stated in previous descriptions and will last 1 to 2 sessions. Study 2 will begin with 1 session with the researcher lasting about 30 minutes. Then participants will be asked to complete practice at home for about 15 minutes each day for 2 weeks using a computer/iPad. Study 2 Post Testing and Maintenance Sessions 1 and 2: approximately 60 minutes per session.
15944113|NCT03309917|Other|MAP set at 80-85 mmHg for 5 min|MAP is set at 80-85 mmHg for 5 min by infusion of noradrenaline.
15944114|NCT03309917|Other|MAP set at 70-75 mmHg for 5 min|MAP is set at 70-75 mmHg for 5 min by infusion of noradrenaline.
15944115|NCT03309917|Other|MAP set at 60-65 mmHg for 5 min|MAP is set at 60-65 mmHg for 5 min by infusion of noradrenaline.
15944116|NCT03309904|Other|Knee Control training program|10-minute training program to be performed at all team training sessions during the season.
15944117|NCT03309891|Drug|GX-H9|subcutaneous injection (weekly or twice-monthly)
15944118|NCT03309891|Drug|Genotropin|subcutaneous injection (daily)
15944119|NCT03309878|Biological|Mogamulizumab|Given IV
15944120|NCT03309878|Biological|Pembrolizumab|Given IV
15944121|NCT03309865|Dietary Supplement|semi-vegetarian diet|semi-vegetarian dietary intervention: Duration of Therapy: 14 weeks;
15944122|NCT03309865|Drug|Vedolizumab Injection|vedolizumab (300mg) IV infusions at week 0, 2, 6, 14; Duration of Therapy: 14 weeks
15944123|NCT03309839|Other|Blood collection|A sample of an additional blood tube will be taken in parallel with the blood test carried out for the treatment.
15944124|NCT03309826|Device|Positive Airway Pressure|Auto-PAP titration followed by fixed PAP treatment
15944125|NCT03309826|Device|Nasal Dilator Strip|Nightly use of nasal dilator strip
15944126|NCT03309813|Device|Transcranial ExAblate|ExAblate Thalamotomy for Chronic Trigeminal Neuropathic Pain
15944127|NCT03309813|Device|Sham Transcranial ExAblate|Sham ExAblate Thalamotomy procedure
15944128|NCT03309800|Drug|HL301|HL301: 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment
15944129|NCT03309800|Drug|HL301(Placebo)|HL301(Placebo): 2Tab/day: 1 Tablet at once, 2 times a day, 7 days of treatment
15944130|NCT03309787|Behavioral|eHealth|Intervention Description: The pilot comprises of five components listed below which provide access to specialty obesity care to rural obese adults, and enhance it with technology (telehealth and remote monitoring): Team-based care; medical plan, nurses, psychologists, dietician, Health coaching, Weekly coaching sessions , Messaging and Remote Monitoring
15944131|NCT03309774|Diagnostic Test|questionnaires|"Children with Complex Regional Pain Syndrome (CRPS) will be filled questionnaires before and after relaxation sessions. These questionnaire evaluate the quality of life and pain of child
~There will be:
~Questionnaire KIDSCREEN 52
~Visual Analogue Scale (EVA)
~Neuropathic Pain 4 (DN4)
~Pain of the child Gustave Roussy (DEGR)"
15944132|NCT03309774|Diagnostic Test|holter electrocardiogram|Children with Complex Regional Pain Syndrome (CRPS) will be have holter electrocardiogram before and after relaxation sessions.
15944133|NCT03309774|Diagnostic Test|blood pressure|Blood pressure of Children with Complex Regional Pain Syndrome (CRPS) will be measured by Nexfin monitor before and after relaxation sessions.
15944134|NCT03309774|Other|relaxation sessions|"Children with Complex Regional Pain Syndrome (CRPS) will be performed 20 relaxation sessions and 2 per week.
~During relaxation sessions children will be recorded by voice recorder. Children should describe his feelings at the preceding session.
~After every relaxation sessions children evaluate pain according to Eland Color Scale."
15944135|NCT03309761|Other|Blood test|6ml blood sample taken
15944136|NCT03309748|Procedure|Dental prophylaxis|American Dental Association, Code on Dental Procedures and Nomenclature (CDT) CDT code D1110
15944137|NCT03309748|Device|Dental prophylaxis + antimicrobial photodynamic therapy|Dental prophylaxis using American Dental Association, Code on Dental Procedures and Nomenclature (CDT) CDT code D1110 followed by two 8-minute irradiation cycles using GLO Brilliant home use whitening device (GLO ™ Science LLC, New York, USA).
15944138|NCT03309735|Drug|Micronized progesterone|Utrogestan, 200 mg orally thrice a day until acute symptoms of the threat of termination of pregnancy (scarlet discharge from the genital tract, pain in the abdomen) and then Utrogestan vaginally 200 mg twice a day and 200 mg orally once a day before bed
15944139|NCT03309735|Drug|Micronized progesterone|Utrogestan vaginally 200 mg twice a day and 200 mg orally once a day before bed
15944140|NCT03309735|Drug|Dydrogesterone|Duphaston, orally 40 mg once, then 10 mg every 8 hours until the symptoms disappear
15944141|NCT03309722|Other|biomarker study|
15944142|NCT03309709|Drug|subcutaneous progesterone|25mg daily for 7 days
15944143|NCT03309696|Device|sham tDCS and sham rTMS|Both combinations of tDCS and rTMS in this intervention are sham.
15944144|NCT03309696|Device|sham tDCS and active rTMS|tDCS in this intervention is sham and rTMS is active
15944145|NCT03309696|Device|active tDCS and active rTMS|Both combinations of tDCS and rTMS in this intervention are active
15944146|NCT03309683|Device|Olympus Quick Clip Pro - Single Use Repositionable Clips|A hemoclip will be placed after every 0,5-1,0 cm of the resected area to proximate wound edges.
15944147|NCT03309670|Other|Psychiatric future|Former young psychiatric patients are contacted to determine their psychiatric outcome.
15944148|NCT03309657|Drug|Ceftolozane/tazobactam|This is an observational pharmacokinetic study whereby patients received a single dose of ceftolozane/tazobactam and plasma and cerebrospinal fluid samples were subsequently collected and analyzed to described the pharmacokinetics.
15944149|NCT03309644|Other|Peripheral nerve blockade|Participants who receive a peripheral nerve block identified through the medical chart.
15944150|NCT03309644|Other|No peripheral nerve blockade|Participants who did not receive a peripheral nerve block identified through the medical chart.
15944151|NCT03309631|Diagnostic Test|In vitro Diagnostic|
15944152|NCT03309618|Drug|low-dose combination of fluvastatin (10 mg) and valsartan (20 mg) (low-flu/val)|
15944153|NCT03309618|Drug|placebo|
15944154|NCT03309605|Drug|ELX-02|ELX-02 is a synthetic, designer eukaryotic ribosomal specific glycoside (ERSG) optimized as a translational read-through drug
15944155|NCT03309605|Drug|Placebo|Placebo
15944156|NCT03309592|Drug|Ambrisentan Pill|Will be administered as stated in Arm/Group Descriptions
15944157|NCT03309592|Drug|Tadalafil Pill|Will be administered as stated in Arm/Group Descriptions
15944158|NCT03309579|Other|Liberal RBC Transfusion Strategy|RBC transfusion is triggered by a Hemoglobin value of ≤100g/L
15944159|NCT03309579|Other|Restrictive RBC Transfusion Strategy|Optional RBC transfusion is triggered by a Hemoglobin value of ≤80g/L
15944160|NCT03309566|Drug|Efavirenz, tenofovir disoproxil fumarate and emtricitabine|Two period administration of a formulation containing a combination of efavirenz 600 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg.
15944161|NCT03309553|Other|Current Primary Care Referral Process|Children who screen positive for hearing loss will receive the same method each school had been using previously. This process involves a letter home to the parents, either sent with the child or by mail, requesting that the parent/caregiver bring the child to village health clinic for an evaluation.
15944162|NCT03309553|Other|Telemedicine Referral Process|In villages randomized to the expedited telemedicine intervention, parents of children who screen positive will receive a phone call from the school or the clinic on the day of screening notifying them of the day and time of their child's telemedicine consultation appointment. Appointments will be made same-day or next-day, with community health aides (CHAs) who have dedicated time blocked off to perform telemedicine consults. Participating children screening positive will be transported to clinic for their appointment with adult chaperones. Parents are encouraged but not required to attend, except for children grades 2 and younger, for whom parental participation will be required. Nonparticipating children in communities assigned to the expedited telemedicine intervention arm will receive standard referral following the current school primary care referral process.
15944163|NCT03309540|Other|Physioterapy intervention|"In the experimental group (EGR), the 4MTOR® treatment method will be used for LBP. This 4MTOR® uses the following steps in a decision tree: T1 Testing (Physiotherapeutic examination), T2 Triggering (Manual Techniques), T3 Taping (Elastic Tape) and T4 Training (medical rehabilitation exercises).
~The participants in the SGR received a sham multimodal physiotherapeutic intervention as control intervention, in which Sham technique were applied. The interventions consisted of combining Sham manual interventions, elastic tapes according to Kaze32 and Evidence Based Practice Therapy (Appendix III). The protocol in the SGR follows the similar steps: Testing, Taping, Triggering and Training like the 4MTOR®."
15944164|NCT03309527|Behavioral|e-aid Cognitive Behavior Therapy|e-aid Cognitive Behavior Therapy
15944165|NCT03309527|Behavioral|e-aid Sleep Hygiene Education|e-aid Sleep Hygiene Education
15944166|NCT03309514|Biological|Intracerebral microinjections|Stereotactic delivery of cell suspension into basal ganglia structures
15944167|NCT03309501|Drug|Tong-Luo-Qu-Tong Plaster|for 14 days as two period of treatment, daily 1 time.
15944168|NCT03309501|Drug|Qi-Zheng-Xiao-Tong Plaster|for 14 days as two period of treatment, daily 1 time
15944169|NCT03309488|Diagnostic Test|Oral food challenge|Patients with suspected food allergy will undergo clinical and dietary assessments and oral food challenge. Different allergy tests will be performed, including skin prick test, specific IgE test and basophil activation test, and its diagnostic utility will be determined against the clinical gold-standard.
15944170|NCT03309475|Behavioral|SocialMIND|SocialMind is a mindfulness-based intervention including elements such as radical acceptance, decentering or meditation-techniques. It is designed to target social cognition, defined as the ability to recognize, understand and benefit from social stimuli.
15944171|NCT03309475|Behavioral|Psychoeducational multicomponent intervention|The psychoeducational multicomponent intervention addresses and discuss several aspects of great importance for persons who suffer a first episode of psychosis, such as biased perception and thinking, delusions-related anxiety or the nature of hallucinations. Its aim is to encourage patients to reflect upon their experiences from a critic perspective.
15944172|NCT03309475|Behavioral|Psychosocial treatment|Treatment as usual delivered by patient's practitioner
15944173|NCT03309475|Drug|Psychotropic treatment|Treatment as usual delivered by patient's practitioner
15944174|NCT03309462|Device|Miseq sequencer|The sequencer will be used to detect the gene mutations of the re-biopsy tissue samples and peripheral blood samples obtained from patients.
15944175|NCT03309449|Device|Syringe and needle|Intramuscular administration of simulated naloxone
15944176|NCT03309449|Device|Intranasal mucosal atomization device|Intranasal atomizer administration of simulated naloxone
15944177|NCT03309449|Device|Nasal spray|Nasal spray administration of simulated naloxone
15944178|NCT03309436|Drug|Clomiphene Citrate protocol|Take CC 100mg/d at the same time with Gn until hCG injection.
15944179|NCT03309436|Procedure|Procedure|When a dominant follicle diameter over 14mm or serum E2 over 350pg/ml, use GnRH-ant 0.25mg/d, until hCG injection.
15944213|NCT03309124|Other|Fried French fries|Prepared from frozen, matched for energy and available carbohydrate content of baked potato and salt content of white bread.
15944214|NCT03309124|Other|Meal skipping|No food given
15944215|NCT03309111|Biological|ISB 1342|ISB-1342 is CD38 x CD3 BEAT® 1.0 bispecific antibody. ISB 1342 is administered by intravenous (IV) infusion
15980407|NCT03033862|Device|Drug Eluting Stent|Drug Eluting Stent
15944180|NCT03309423|Diagnostic Test|venous to arterial conversion (v-TAC)|Venous to arterial conversion (v-TAC) is a software (Obimedical, Denmark), which can convert venous blood gas values to arterial blood gas values. The principle of the method is a mathematical transformation of VBG values to arterialized values (aVBG) by simulating the transport of blood back through the tissue. To facilitate this simulation the following physiologically relevant assumptions were made: 1) The peripheral extremity was well perfused; 2) change in base excess across the tissue sampling site was approximately zero; 3) the respiratory quotient (rate of CO2 production and O2 utilisation over capillaries) could not vary outside the range 0.7 and 1.0, and 4) the haemoglobin concentration was constant from artery to vein.
15944181|NCT03309410|Diagnostic Test|Venous to arterial conversion (v-TAC)|This was an observational study. Paired arterial blood gas and venous blood gas was drawn from each patient and compared. Venous blood gas was converted to arterial blood gas values using v-TAC.
15944182|NCT03309358|Drug|Inhaled SNSP113|A single ascending dose of inhaled SNSP113 will be administered to healthy subjects and subjects with stable cystic fibrosis.
15944183|NCT03309358|Drug|Inhaled Placebo|A single dose of inhaled placebo control will be administered to healthy subjects and subjects with stable cystic fibrosis.
15944184|NCT03309345|Other|No intervention|No intervention as this is an observational study investigates the difference between PKU ant matched healthy control in terms of energy components and dietary intake
15944185|NCT03309332|Device|AMPLATZER™ PFO Occluder|Implantation of the AMPLATZER™ PFO Occluder in the PFO
15944186|NCT03309319|Drug|Rosiglitazone|rosiglitazone is added to the primary treatment
15944187|NCT03309306|Other|Natural Environment/Stress Management|Participants will use the FoodImage app to capture data on food purchases, food waste that occurs during food preparation, food waste that is present after eating, and food waste from food purges in free-living conditions. Participants will capture baseline data for 4-7 days. After a 1-week break, participants will use the app to record food waste for approximately 4-7 days over the subsequent week. They will also receive information on stress management
15944188|NCT03309306|Behavioral|Natural Environment/Reduce Food Waste|"Participants will use the FoodImage app to capture data on food purchases, food waste that occurs during food preparation, food waste that is present after eating, and food waste from food purges in free-living conditions. Participants will use the app to record food waste for approximately 4-7 days over the subsequent week. They will also be provided with the following:
~Feedback on the amount of food waste their household created during the first week,
~A goal to reduce the next week's food waste by 20% or more, and
~Tips on how to reduce household food waste adapted from current consumer campaigns"
15944189|NCT03309293|Biological|blood samples|blood samples
15944190|NCT03309280|Other|Duration of intubation|Time between intubation in the operating room and exhumation in the Intensive Care Unit.
15944191|NCT03309280|Diagnostic Test|Evolution of the renal function|Evolution of the renal function in the next two days
15944192|NCT03309267|Procedure|Intercostal block|Intercostal block +patient controlled analgesia
15944193|NCT03309267|Procedure|Serratus anterior plane block|Serratus anterior plane block+patient controlled analgesia
15944194|NCT03309254|Other|High Glycemic Index|High Glycemic Index Food
15944195|NCT03309254|Other|Low Glycemic Index|Low Glycemic Index Food
15944196|NCT03309241|Drug|PF-06882961|Single Ascending Doses of PF-06882961 from 3mg to TBD mg.
15944197|NCT03309241|Other|Placebo|Placebo Single Dose
15944198|NCT03309228|Other|individual interviews|Semi-structured individual interviews with patients, relatives and general practitioners.
15944199|NCT03309215|Other|Experimental stimulation with nickel discs|"All participants will be exposed to 8 metal discs, 3 cm in diameter, 4 on each arm, placed on the volar side of the forearms (figure 1). Three of the metallic discs consists of >99 wt.% nickel one consist of >99wt.% Aluminium.The latter is used as a negative control. The discs will be applied under occlusion and with initial pressure and friction.
~One metallic disc with nickel, and one with aluminium, will be randomized for the earlobes on the patients with nickel allergy"
15944200|NCT03309202|Drug|PF-05221304|25 mg dose
15944201|NCT03309176|Drug|Medroxyprogesterone Acetate 10 MG|Patients in the standard arm will receive Medroxyprogesterone Acetate 10mg daily for 10 days prior to the first ovulation induction cycle and in between anovulatory cycles.
15944202|NCT03309176|Other|Stair step protocol without Medroxyprogesterone Acetate|No administration of Medroxyprogesterone Acetate prior to each cycle. Stair step method: rapidly increasing the dose of clomiphene citrate in case of no follicular response
15944203|NCT03309163|Drug|Tramadol|Patient-controlled intravenous analgesia with Tramadol
15944204|NCT03309163|Drug|Hydromorphone|Patient-controlled intravenous analgesia with Hydromorphone
15944205|NCT03309163|Drug|Ropivacaine (Epidural analgesia)|Patient-controlled epidural analgesia with Ropivacaine.
15944206|NCT03309150|Drug|M6620|Participant will either receive M6620 intravenously as a monotherapy on Day 1, 8 and 15 OR as a combination therapy on Day 2 and 9 of the study.
15944207|NCT03309150|Drug|Carboplatin|Participant will receive carboplatin intravenous infusion as a combination therapy on Day 1 of the study.
15944208|NCT03309150|Drug|Paclitaxel|Participant will receive paclitaxel intravenous infusion as a combination therapy on Day 1, 8 and 15 of the study.
15944209|NCT03309137|Device|Chlorhexidine flush|"For patients randomized to the CHG-LockTM device, attach a attach a BD Posiflush ™ 0.9% Sodium Chloride (Na Cl) 10ml syringe and a CHG-Lock™ device for each IV line that is to be locked. Follow hospital approved protocol for flush, volumes and hand hygiene.
~After a Catheter has been locked, before re-accessing the catheter for further sampling or infusions, all fluid should be aspirated from the catheter to clear the device of CHG, Heparin and the like. This should also confirm patency of the device.
~Discard the syringe and device in biohazard waste.
~Blue Cap the IV as per routine practice."
15944210|NCT03309124|Other|White bread|Toasted, with canola oil added to match for fat content of French fries (13.9 grams), as well as being matched for energy (280 kilocalories) and available carbohydrate content (33 grams) of potato treatments.
15944211|NCT03309124|Other|Baked potato with skin|Baked russet potato with canola oil added once baked to match for fat content of French fries, and also matched for the salt content of white bread (280 milligrams).
15944212|NCT03309124|Other|Mashed potatoes|Mashed potatoes prepared from frozen, with canola oil added to match for fat content of French fries, as well as being matched for energy and available carbohydrate content of the baked potato.
15944216|NCT03309098|Diagnostic Test|Ligmaster Arthrometer Assessment|Perform an anterior drawer, inversion stress test and eversion stress test on the participant with an ankle arthrometer (LigMaster Version 1.26, Sport Tech, Inc, Charlottesville, Virginia).
15944217|NCT03309085|Procedure|Repeated CT scan|CT scan of chest on different PEEP levels, 4 in total
15944218|NCT03309085|Device|CT scan|CT scan
15944219|NCT03309072|Device|tDCS|active tDCS
15944220|NCT03309072|Device|sham tDCS|sham tDCS
15944221|NCT03309059|Device|water and soap|Use of soap and water in the area and subsequent diaper placement disposable.
15944222|NCT03309059|Device|zinc oxide|Use of soap and water sanitation and application of zinc oxide.
15944223|NCT03309059|Device|Non-Irritant Barrier Film|Use of soap and water hygiene and application of Non Irritant Barrier Film.
15944224|NCT03309046|Other|REACH Individual Session|Individual telephone session with parent
15944225|NCT03309046|Other|Education Webinar|Videos with information on caregiving
15944226|NCT03309033|Procedure|Biospecimen Collection|Undergo collection of blood samples
15944227|NCT03309033|Other|Laboratory Biomarker Analysis|Correlative studies
15944228|NCT03309033|Other|Questionnaire Administration|Complete questionnaire
15944229|NCT03309020|Procedure|Cataract surgery|Cataract surgery and aqueous humor sampling.
15944230|NCT03309007|Drug|Metformin|Total daily dose titrated up to 1500 mg po q day over the course of 4 weeks and continued for a total exposure of 12 weeks.
15944231|NCT03309007|Drug|Placebo Oral Tablet|Total daily dose titrated up to 1944 mg po q day over the course of 4 weeks and continued for a total exposure of 12 weeks.
15944232|NCT03308994|Other|Delay between MS onset and introduction of first line DMT|Delay between MS onset and introduction of first line DMT : time between date of MS onset ( the first demyelinating neurological events clinically defined) and date of the introduction of the first-line oral DMT (Interferons, Glatiramer Acetate, Dimethyl Fumarate and Teriflunomide)
15944233|NCT03308994|Other|EDI|For all cases of multiple sclerosis residence's places of each patient were geolocalized with a Geographic Information System (ARCGIS 10.2) and assigned to an IRIS, IRIS (Ilots Regroupés pour l'Information Statistique) is the smallest French geographic unit for which census data are available and EDI score was calculated for each IRIS. In order to attribute a social deprivation score to the IRIS, we used the French EDI (European Deprivation Index). EDI stands as a continuous variable but EDI will be used as a categorical variable in order to increase the comparability with others studies, so EDI is distributed into quintiles calculated at the French level.
15944234|NCT03308981|Device|REThink therapeutic online game|The REThink therapeutic online game has seven levels. Each level has various degrees of complexity, which increase as the player progresses in the game. The scenario of the game was developed based on the REBT model, such that it focuses on: a. identifying the emotional and behavioral reactions; b. identifying cognitive processes; c. identifying the relation between cognitive processes and emotions and behavioral reactions; d. changing irrational cognitions into rational cognitions; e. building problem solving skills; f. building relaxation skills and g. building happiness skills.
15944235|NCT03308981|Other|REBE group|In the Rational-Emotive-Behavioral Education (REBE) group participants will follow 7 modules, structured based on the strategies practiced in each of the REThink level.
15944236|NCT03308968|Drug|Fremanezumab|Fremanezumab will be administered per dose and schedule specified in the arm.
15944237|NCT03308968|Drug|Placebo|Placebo matching to fremanezumab will be administered per schedule specified in the arm.
15944238|NCT03308955|Drug|Tramadol|400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.
15944239|NCT03308955|Procedure|Ultrasound guided Quadratus Lumborum block|Ultrasound guided Quadratus Lumborum block type II with 0.3 ml/kg % 0.25 bupivakain+400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.
15944240|NCT03308955|Procedure|Ultrasound guided placebo Quadratus Lumborum block|Ultrasound guided placebo Quadratus Lumborum block type II with 0.3 ml/kg saline % 0,9+400 mg tramadol, IV 4 mg/ mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.
15944244|NCT03308929|Device|G7 Dual Mobility hip|Total hip arthroplasty and implantation of the G7 device
15944245|NCT03308916|Diagnostic Test|transient elastography|Ultrasound elastography using shear-wave elastography to measure liver stiffness as a marker of liver fibrosis. Patients with transient elastography above 8.0 kPa selected for liver biopsy to detect advanced liver fibrosis
15944246|NCT03308916|Diagnostic Test|Enhanced liver fibrosis test|Patented, commercially available algorithm of hyaluronic acid (HA), N-terminal propeptide of collagen type 3 (P3NP) and tissue inhibitor of metalloproteinase 1 (TIMP-1)
15944247|NCT03308916|Diagnostic Test|Indirect serum markers of liver fibrosis|Diagnostic markers using combination of routine liver biochemistry: age, AST, ALT, platelet count, cholesterol, GGT
15944282|NCT03308669|Drug|Topiramate|Administered orally
15944248|NCT03308916|Diagnostic Test|Direct serum markers of liver fibrosis|Serum markers that reflect liver extracellular matrix turnover and -accumulation
15944249|NCT03308916|Diagnostic Test|LiverTRAIL|Software that contain 199 diagnostic algorithms, containing combinations of routine tests: age, AST, albumin, alkaline phosphatase, bilirubin, GGT, INR, platelet count, cholesterol and sodium, and specialist tests: transient elastography and direct serum markers of fibrosis.
15944250|NCT03308916|Diagnostic Test|Cytokeratin 18|Cytokeratin 18 from liver cell cytoskeleton; when cells undergo apoptosis, caspase-cleaved CK18 is released (M30), whereas full-length CK18 is realised during necrosis (M65)
15944251|NCT03308916|Diagnostic Test|Omics markers|Markers combining signatures of liver fibrosis and hepatic inflammation from many 'omics technologies
15944252|NCT03308903|Diagnostic Test|DEXA scan|The participant will undergo a whole-body DEXA (DEXA; GE Medical Systems, Chalfont St Giles, UK) scan, lasting approximately 5 minutes. This scan will produce body composition data, including estimates of lean body mass (LBM), appendicular lean mass (aLM) and body fat percentage (BF%).
15944253|NCT03308890|Drug|0.5mg Baraclude(entecavir)|0.5mg Baraclude (entecavir) QD for 6 months after cessation of TDF.
15944254|NCT03308890|Drug|0.5mg Baraclude(entecavir)|0.5mg Baraclude (entecavir) QD for 12 month after cessation of TDF.
15944255|NCT03308877|Behavioral|BMI|Four 45-minute, brief motivational sessions for substance use
15944256|NCT03308877|Behavioral|Stadard Care (SC)|Standard procedures at pretrial program + assessement
15944257|NCT03308864|Behavioral|Interpersonal Psychotherapy for Adolescents|Experimental: Interpersonal Psychotherapy for Adolescents (IPT-A) IPT-A is a manualized intervention for depression that targets adolescents' interpersonal context and social supports as mechanisms of change. It will be provided in accordance with the treatment manual by Child and Adolescent Outpatient Service clinicians over the course of 12-16 50-minute sessions.
15944258|NCT03308864|Behavioral|Treatment as usual|Treatment as usual will consist of the standard care for adolescent depressive symptoms at CAOS. TAU is not manualized; it is consistent with care typically provided in community settings. Therapists establish a working alliance, are empathetic, reflect expressed affect, and discuss options for coping with concerns as initiated by the adolescent.
15944259|NCT03308851|Procedure|Piezocorticision|The piezocorticision is a procedure that aims to accelerate the movement of teeth during an orthodontic treatment. It consists of a local anaesthesia followed by an incision of the buccal mucosa and an incision in the alveolar bone with a piezotome.
15944260|NCT03308851|Procedure|Osteoperforation|The osteoperforation is a procedure that aims to accelerate the movement of teeth during orthodontic treatment. It consists of a local anaesthesia followed by perforations of the buccal mucosa and alveolar bone using a specific osteoperforation tool.
15944261|NCT03308825|Biological|Fluzone Quadrivalent vaccine|0.25 mL, Intramuscular
15944262|NCT03308825|Biological|Fluzone Quadrivalent vaccine|0.5 mL, Intramuscular
15944263|NCT03308825|Biological|Fluzone High-Dose vaccine|0.5 mL, Intramuscular
15944264|NCT03308812|Behavioral|Health360x|Participants will view an orientation video which will include information on how to access the program from home and other internet access sites, how to use their activity monitor and sphygmomanometers, introduction to the curriculum, quizzes and discussion boards. Participants will be encouraged to upload their data at least once a week and to access the curriculum as often as desired. Technological and customer service support related to use of the application will be available 24 hours by phone.
15944265|NCT03308812|Behavioral|Health Coach|Participants will be contacted by the health coach in the first week of the study to review their initial self-management behavioral goals and approaches. Follow up calls will occur each week for the first month, biweekly for the second and third months, and then once per month for the remainder of the study (months 4-6).
15944266|NCT03308799|Drug|MC2-01 cream|MC2-01 (calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%) cream
15944267|NCT03308799|Drug|Cal/BDP combination|calcipotriene/betamethasone dipropionate, w/w 0.005%/0.064%
15944268|NCT03308799|Drug|Cream vehicle|Vehicle Cream
15944269|NCT03308786|Drug|Recombinant Interleukin-2|Subcutaneous recombinant interleukin-2 (rIL2), 5 MIU twice daily for five consecutive days every 8 weeks for 8 weeks
15944270|NCT03308773|Other|Lifestyle modification in routine care of patients|Diabetes Prevention Program Lifestyle recommendations and non-investigational pharmacotherapy in routine care of patients
15944271|NCT03308760|Other|Questionnaire|Interview concerning the post-operative rehabilitation programme and a functional analysis using the American Orthopaedic Foot and Ankle Society questionnaire
15944272|NCT03308760|Other|Static stabilometry|on a force plate, in a double- then single-foot stance, with the eyes open and then closed
15944273|NCT03308760|Other|Isokinetic test|Isokinetic test of the flexors/extensors and invertors/evertors of the ankle
15944274|NCT03308747|Dietary Supplement|Instantized Whey Protein Isolate|0,4 g of whey protein isolate/kg body weight will be ingested as a bolus of 250 ml immediately after the resistance exercise bout.
15944275|NCT03308734|Behavioral|Reduced-Exertion High-Intensity Interval Training|The 6-week REHIT protocol will involve 3 training sessions a week. Each session will include 10 minutes of unloaded pedalling using a cycle ergometer. Volunteers will be asked to increase to their maximal pedal frequency possible for 1-2 seconds prior to applying a resistance of 5 % of pre-training body weight for the Wingate sprint. The sprints will take place at 2 minutes and at 6 minutes. Sprint duration will be increased from 10 seconds in the first week to 15 seconds in the second and third weeks and finally 20 seconds in the remaining weeks. Patients will receive strong verbal encouragement during the sprints after which the resistance will be removed.
15944276|NCT03308721|Drug|NNC9204-1177 A 1.0 mg/mL|"Participants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks.
~Dose gradually increased to 6000 μg."
15944277|NCT03308721|Drug|PLACEBO|Participants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks.
15944278|NCT03308708|Drug|Norepinephrine infusion|Norepinephrine infusion (5miclml) is immediately started after spinal anesthesia. Rate starts at 30 ml/h and modified according to hemodynamic state
15944279|NCT03308682|Drug|177Lu-DOTA-EB-TATE|The patients were intravenously injected with single dose 0.50GBq-0.70GBq (13.5-18.9 mCi) of 177Lu-DOTA-EB-TATE and monitored at 2, 24, 72, 120 and 168 hours post-injection.
15944280|NCT03308669|Drug|Lasmiditan|Administered orally
15944281|NCT03308669|Drug|Placebo|Administered orally
15944283|NCT03308656|Other|uterocervical angle|uterocervical angle is the angle between lower segment of uterus and cervix
15944284|NCT03308643|Drug|Oxytocin|Patients will receive intravenous oxytocin infusion just before the surgery after the induction of general anesthesia.
15944285|NCT03308643|Other|saline|Patients will receive intravenous normal saline infusion just before the surgery after the induction of general anesthesia.
15944286|NCT03308630|Behavioral|Yoga based Energy Alignment and Mantra|"Yoga intervention was based on the concept that there is not just a physical body, but a subtle energy body can be bound with residue of stress, unprocessed emotions, and excess mental energy. Using Yoga based practices combined with Mantra chants, Music and energy alignments poses, stress induced pain can be alleviated."
15944287|NCT03308604|Drug|Polysiloxane Gd-Chelates based nanoparticles (AGuIX)|"Three intravenous injections of AGuIX will be delivered.
~The first injection of AGuIX will be delivered intravenously the 1st day and the 11th day of EBRT. The first injection will be preceded with an MRI (unenhanced T1 and T2 sequences) then followed with another MRI performed 4 hours later, to monitor tumor uptake.
~Irradiation will be performed after the second MRI.
~The second injection will be followed by an MRI 4 hours later.
~The third injection will be delivered intravenously the day of the brachytherapy procedure. Intravenous hydration will be performed during all brachytherapy courses to ensure AGuIX clearance.
~Up to three dose levels may be explored: 20mg/kg (level -1), 30 mg/kg (level 1) and 50 mg/kg (level 2). The starting dose level will be 30mg/kg."
15944288|NCT03308604|Radiation|External beam radiotherapy (EBRT)|to the pelvis, with intensity modulated technique: 45 Gy in 5 weeks, with integrated boost to 55 - 57.5 Gy in case of macroscopic lymph node metastases
15944289|NCT03308604|Radiation|Uterovaginal brachytherapy|15 Gy (maximal interval between EBRT and brachytherapy: 14 days).
15944290|NCT03308604|Drug|Chemotherapy (cisplatin)|Concomitant weekly intravenous cisplatin 40 mg/m2 will be delivered (total 5 cycles).
15944291|NCT03308591|Drug|NACT|Platin based chemotherapy
15944292|NCT03308591|Procedure|RT+PLND|radical hysterectomy+pelvic lymphadenectomy
15944293|NCT03308591|Drug|Adjuvant chemotherapy|Platin based chemotherapy
15944294|NCT03308578|Drug|Atorvastatin|Subjects randomized to this arm will receive 40 mg capsules, once daily dose for the first 4 weeks followed by 2X40mg capsules, once daily dose for remaining 5 months of the study
15944295|NCT03308578|Drug|Placebo oral capsule|Subjects randomized to this arm will receive placebo capsules, once daily dose for the first 4 weeks followed by 2X40mg capsules, once daily dose for remaining 5 months of the study
15944296|NCT03308565|Biological|Autologous, Adipose derived Mesenchymal Stem Cells|The mesenchymal stem cells will be collected and expanded from the subjects adipose tissue.
15944297|NCT03308552|Radiation|SIB-IMRT|PTV:50.4Gy/28f, PGTV:59.92Gy/28f
15944298|NCT03308552|Drug|Paclitaxel|45-50 mg/m2, once a week, concurrent with radiotherapy for 5-6weeks
15944299|NCT03308552|Drug|Platinum-Based Drug|Nedaplatin or Lobaplatin or Cisplatin, 20-25mg/m2, once a week, concurrent with radiotherapy for 5-6weeks
15944300|NCT03308552|Drug|Paclitaxel|150mg/m2 on day1,every 3 weeks, 4 cycles, 1-3 months after completion of radiotherapy
15944301|NCT03308552|Drug|Platinum-Based Drug|Nedaplatin or Lobaplatin or Cisplatin, 50-80mg/m2 on day1 (Lobaplatin 50mg on day 1),every 3 weeks, 4 cycles, 1 month after completion of radiotherapy
15944302|NCT03308539|Radiation|echocardiography and cardiac magnetic resonance|transthoracic echocardiography and magnetic resonance imaging of the heart
15944303|NCT03308500|Behavioral|High-intensity intermittent games|The intervention will last for 12-weeks, each group included participation in twice-week 40 minutes exercise sessions. In HIIG children took part in 5 games per session; 2 velocity games and 3 small-sided games (such 3 vs 3 and 4 vs 4). This session included 4 minutes games and 2 minutes recovery. In MIG children took part in 5 games per session. This session included 4 minutes games and 3 minutes recovery.
15944304|NCT03308500|Behavioral|Moderate intensity games|The intervention will last for 12-weeks, each group included participation in twice-week 40 minutes exercise sessions. In MIG children took part in 5 games per session. This session included 4 minutes games and 3 minutes recovery.
15944305|NCT03308487|Dietary Supplement|vitamin D3 (1000 IU)|
15944306|NCT03308487|Dietary Supplement|Vitamin D3 (2000 IU)|
15944307|NCT03308474|Other|Routine care as per site standard.|Physician's choice according to patient's needs.
15944308|NCT03308461|Drug|Fecal Microbiota suspension|The prepared microbiota suspension was infused into mid-gut.
15944309|NCT03308448|Drug|Recombinant human erythropoietin|Intravenous administration of recombinant human erythropoietin (4000 u/vial) with different dosage for each group
15944310|NCT03308435|Diagnostic Test|Geriatric assessment|the assessment includes functional tests (hand grip strength, SPPB (Short Physical Performance Battery)) and questionaires Euro-QoL 5D, LUTS, GDS, ADL, iADL, dietary recall).
15944311|NCT03308435|Diagnostic Test|Psychiatric assessment|Psychiatric assessments includes HAMD-17 as well as Beck depression inventory, hospital anxiety and depression scale, SF36, PTSS-10
15944312|NCT03308435|Diagnostic Test|Inflammatory assessment|analysis will include arginase, ADMA, SDMA, homoarginine, aminoacids + metabolites, tryptophan, kynurenine, kynurenine acid, cortisol, ACTH, Metanephrine, myeloperoxidase,
15944313|NCT03308435|Diagnostic Test|Cardiological assessment|ECG, echocardiography
15944314|NCT03308422|Behavioral|parental representations|parental representations of the impact of the use of screens on their preschool children health and development
15944315|NCT03308409|Other|Low-intensity extracorporeal shock wave therapy (Li-ESWT)|Low-intensity shock waves are acoustic wavelengths which are transmitted continuously at a frequency between 16 and 20 megahertz for under 10 microseconds. They generate a pressure pulse and transport energy as they propagate through a medium. Three different methods can be used to generate this type of wave: electro-hydraulics, electro-magnetics and piezoelectricity. Regardless of the method, when the shock waves are applied to an organ they interact with the deep tissue. This causes stress and small mechanical traumas, activating the release of angiogenic factors which induce new vascularization of the affected tissue, thereby improving blood flow.
15944316|NCT03308396|Drug|Guadecitabine|Days 1-5 Dose 0: 60 mg/m^2 Dose -1: 45 mg/m^2
15944317|NCT03308396|Drug|Durvalumab|Day 8 Durvalumab (1500 mg IV)
15944318|NCT03308383|Other|DOING TRANSTHORACIC ECHOCARDIOGRAM|TRANSTHORACIC ECHOCARDIOGRAM WILL BE DONE IN THE PARTICIPANTS WHICH IS NON-INVASIVE
15944798|NCT03304561|Other|Traditional rehabilitation|traditional ACL rehabilitation program
15944319|NCT03308370|Biological|Platelet rich plasma|10 ml of blood will be drawn from the patients on an anticoagulant then it will be centrifuged to get platelet rich plasma that will be injected in the melasma lesions of the patients after its activation with calcium chloride.
15944320|NCT03308357|Diagnostic Test|Drug assays to measure infliximab|See protocol
15944321|NCT03308344|Behavioral|Mindfulness training|The present MT program includes topics related to mindfulness, emotion regulation, and connection. It will be delivered in short, weekly sessions.
15944322|NCT03308331|Other|Tobacco smoking and nicotine patch|Tobacco smoking at each participant's regular cigarette. Over-the-counter nicotine patch use
15944323|NCT03308318|Procedure|The supratemporalis approach|The incision differs according to specific fracture sites. It can be a hockey stick-shaped incision, hemicoronal incision, and full coronal incision. The first layer of dissection was just under the superficial temporalis fascia.Then, approximately at the level of 3-5cm above the zygomatic arch, our modified incision was carried through the deep temporalis fascia.Next, the superficial fat pad was encountered and retracted anteriorly, which was in close contact of the temporal muscle. Finally, a flap that included skin, subcutaneous tissue, the superficial temporal fascia, the areolar fat tissue, the deep temporalis fascia and the superficial temporal fat was reflected as a whole anteriorly, fully exposing the temporal muscle and zygomatic arch.
15944324|NCT03308292|Other|Exercise|Aerobic exercise program
15944325|NCT03308279|Diagnostic Test|Ultrasound|Ultrasound and Anthropometric meassures
15944326|NCT03308266|Diagnostic Test|electromyography|
15944327|NCT03308253|Device|Stimulan Rapid Cure|Calcium sulfate dissolvable beads
15944328|NCT03308253|Drug|Vancomycin|0.5 g Vancomycin per patient
15944329|NCT03308253|Drug|Tobramycin|120 mg tobramycin per patient
15944330|NCT03308253|Other|Standard of Care|Standard of care provided at Hamilton General Hospital consisting of dressings for the wound.
15944331|NCT03308240|Behavioral|Magic Therapy|As described in the arm description
15944332|NCT03308214|Drug|Imipenem|Imipenem 1.0 q 8h
15944333|NCT03308201|Drug|Hemay022+exemestane|"Part one: Hemay022 tablets will be taken orally once daily in doses of 200mg, 300mg,400mg or 500mg for 28 days in combination with exemestane.
~Part two: Hemay022 tablets combination with exemestane."
15944334|NCT03308201|Drug|Hemay022+letrozole|Part two: Hemay022 combination with letrozole.
15944335|NCT03308201|Drug|Hemay022+ fulvestrant|Part two: Hemay022 combination with fulvestrant.
15944336|NCT03308188|Behavioral|E-health program|The Goalistics Chronic Pain Management Program, referred to as the E-health program in EMPOWER, was developed from cognitive, behavioral, interpersonal, and self-management interventions with demonstrated efficacy in traditional face-to-face or group settings. It is patient-centered, having been developed based on substantial input from people with chronic pain and chronic pain professionals.
15944337|NCT03308175|Device|flat fixed anterior bite plane|It causes unlocking mandible from deep bite in growing females
15944338|NCT03308175|Device|modified inclined fixed anterior bite plane|It causes unlocking mandible from deep bite in growing females plus putting the mandible in a more forward position
15944339|NCT03308162|Behavioral|Cognitive behavioral experiential group therapy|The Kickstart Health Program is a Cognitive-Behavioral Experiential Therapy (CBET) that is administered via a person-centered group therapy format. Participants receive multiple therapeutic components that include psychoeducation, cognitive behavioral therapy, motivational interviewing, mindfulness, and acceptance and commitment therapy. Participants will also meditate and exercise in the group.
15944340|NCT03308149|Drug|infiltration with triamcinolone and bupivacaine|facet joint infiltration
15944341|NCT03308136|Procedure|1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer.|1) In group A, 1ml of local anesthetics (1% Lidocaine) were injected into the subcutaneous layer.
15944342|NCT03308136|Procedure|1ml of a local anesthetics (1% idocaine) are first injected into the subcutaneous layer, followed by 3~4ml of local anesthetics to the muscle layer along the expected needle pathway.|2) In group B, 1ml of a local anesthetics (1% Lidocaine) are first injected into the subcutaneous layer, followed by 3~4ml of local anesthetics to the muscle layer along the expected needle pathway.
15944343|NCT03308136|Drug|1% Lidocaine|1% Lidocaine
15944344|NCT03308123|Other|Observational study, not interventional|Not an intervention study
15944345|NCT03308110|Drug|PF-06650833|Two formulations of PF-006650833
15944346|NCT03308097|Behavioral|PrEP Mobile Messaging Intervention|See group description
15944347|NCT03308097|Behavioral|Enhanced Standard of Care|See group description
15944348|NCT03308084|Drug|Methylprednisolone|Application of 80mg Depomedrol (methylprednisolone acetate) suspension into the transforaminal space prior to incision closure
15944349|NCT03308084|Drug|Dexamethasone|Administration of 10mg Dexamethasone IV intraoperatively
15944350|NCT03308071|Behavioral|Hypnosis|Hypnotic induction, relaxation, and guided imagery specific to perioperative symptoms will be administered.
15944351|NCT03308058|Behavioral|Breastfeeding computer education|Breastfeeding computer education
15944352|NCT03308045|Biological|pEYS606|pEYS606 is a DNA plasmid solution administered by electrotransfection into the ciliary muscle
15944353|NCT03308032|Behavioral|Intervention|SDL intervention employs a comprehensive engagement design that includes seven innovative strategies: 1) customization of content of the training curriculum to fit individual learner's needs; 2) tailoring the length of trainings by using short video clips to allow caregivers flexibility in completing the curriculum; 3) using an instructional format (SCHOLAR) designed to maximize active learning during each training lesson; 4) progress tracking to help the learner stay focused and motivated; 5) a recommendation algorithm that facilitates the learner's transition from one training topic to the next; 6) behavioral economics-based messages, to re-engage the learner if he/she stops participating
15944354|NCT03308032|Behavioral|Control|Participants in the control group will be invited to a comparable online training course consisting of all of our training video clips, without the interactive engagement design features. These represent standard video training based on evidence-based content.
15944408|NCT03307681|Other|White bread|Toasted, with canola oil added to match for fat content of French fries (13.9 grams), as well as being matched for energy (280 kilocalories) and available carbohydrate content (33 grams) of potato treatments.
15944505|NCT03306914|Other|Hydroxyethylstarch resuscitation|Hydroxyethyl starch 6% is used as the intra-operative colloid
15944355|NCT03308019|Device|Photodynamic therapy|In groups 1 and 2, aPDT was performed after SRP. The protocol for aPDT is described elsewhere. Briefly, using a blunt needle, 0.005% of Methylene blue was applied into the periodontal pocket and left in place for 10 seconds. The dye was then irradiated with a diode laser (670 nanometers) at 150 milliwatts. In each dye filled periodontal pocket, laser irradiation was performed for one minute using a flexible tip. In the present study, aPDT was performed once, at baseline, by a trained dentist.
15944356|NCT03308019|Procedure|Scaling and root planing (SRP)|In both groups, SRP was performed in one session under local anesthesia using handheld Gracey curettes No. 5/6. One trained dental hygienist blinded to the study groups and subgroups made 9 to 10 strokes in a vertical (apico-coronal) direction and the inclination between scaler tips and roots was maintained as zero. When the curved explorer indicated a smooth and hard dental surface, SRP was judged as completed. In all individuals, SRP was done in one session without any assigned time limit for completion.
15944357|NCT03308006|Biological|Stem cells|Participants will be exposed to e abdominal liposuction procedure under local anesthesia for stem cells harvesting. Stem cells will be separated from fat cells in the adipose tissue then activated in Tissue Culture Lab at Research Center- Jeddah. The activated stem cells will be injected into the knee joint via 22G spinal needle. The intra-articular stem cells injections will be performed under Ultrasound guidance at the theater under spinal anesthesia. Each patient will receive 1.0× 108 stem cells in 3 mL of normal saline.
15944358|NCT03307993|Drug|Idalopirdine|Idalopirdine 60-120 mg daily dose
15944359|NCT03307980|Biological|PF-06838435 (formerly SPK-9001)|Gene Therapy: A novel, bioengineered adeno-associated viral vector carrying human factor IX variant
15944360|NCT03307967|Behavioral|SBIRT-PM|SBIRT-PM involves an initial telephone-delivered session followed by up to three calls to Veterans in a 12-week period to support Veteran engagement in multi-modal non-pharmacological pain care and to motivate those who misuse substances to change this problematic behavior. SBIRT-PM also includes coordination between the SBIRT-PM clinicians and the PACT nurse case manager after the initial session to support these patient outcomes.
15944361|NCT03307954|Device|Ekso Therapy (Exoskeleton Suit)|
15944362|NCT03307954|Other|Usual Physiotherapy|
15944363|NCT03307941|Drug|Monalizumab|Monalizumab (IPH2201) is given at the recommended dose of 10 mg/kg, intravenously (infusion during 60 minutes) every two weeks
15944364|NCT03307941|Drug|Oxaliplatin|A total of 4 cycles of FOLFOX is administrated every 2 weeks with one cycle 15 days prior to the radiotherapy and 3 cycles during the radiotherapy whatever the level
15944365|NCT03307941|Drug|5-Fluorouracil|A total of 4 cycles of FOLFOX is administrated every 2 weeks with one cycle 15 days prior to the radiotherapy and 3 cycles during the radiotherapy whatever the level
15944366|NCT03307941|Radiation|Metabolic|Radiation therapy must start the first day of FOLFOX chemotherapy. Radiation is given once daily for 5 consecutive days; on the days that the patient receives chemotherapy (and monalizumab when applicable), chemotherapy (and monalizumab) should be given prior to radiotherapy.
15944367|NCT03307941|Other|Metabolic|18-FDG-PET scan will be performed just before the beginning of radio-chemotherapy (D10-D14) and will be blinded for investigators and patients. Another 18-FDG-PET will be performed before surgery (surgery Day-5 to surgery Day -1) to exclude metastatic evolution
15944368|NCT03307941|Procedure|Surgery|Surgery is performed preferably 8 weeks after the completion of the radio-chemotherapy, and it should not be performed less than one week after the last dose of monalizumab
15944369|NCT03307928|Diagnostic Test|Cardiopulmonary Exercise Test Protocol|The CPET was performed in a cycle ergometer with electromagnetic braking using an Inbrasport (Inbrasport, Porto Alegre, Rio Grande do Sul, Brazil). Following a 5-min warm-up against no resistance (0 W), the work rate was increased using a ramp protocol (5-10 W.min-1) until maximum exercise tolerance. Verbal encouragements were given during the CPET to ensure maximal effort.
15944370|NCT03307928|Diagnostic Test|Polysomnography Assessment|The polysomnography assessment was carried out during an entire night of sleep in the participant's residence with no use of sedatives. The variables were monitored by an Embletta portable respiratory monitor (Embla, Embletta® Gold, EUA), previously validated, and in agreement with manufacturer's instructions. The Embletta monitor was capable to monitor continuously the pulse oximetry, to detect respiratory efforts, to measure the airflow, and to record snoring episodes. Additionally, HR was continually measured by the analysis of pulse waves by oximetry. Finally, brain and muscle activities were monitored by electrodes and oxygen desaturation (O2D) was defined as the amount of reduction in O2S in 4%/h.
15944375|NCT03307902|Biological|Imiquimod + ID HBVv|Imiquimod ointment + intradermal 10μg Sci-B-Vac vaccine
15944376|NCT03307902|Biological|Aqueous + ID HBVv|Aqueous ointment + intradermal 10μg Sci-B-Vac vaccine
15944377|NCT03307902|Biological|Imiquimod + IM HBVv|Imiquimod ointment + intramuscular 10μg Sci-B-Vac vaccine
15944378|NCT03307876|Other|autologous PPP injection|autologous platelet poor plasma (PPP) injection taken from the participants own blood is injected in to all patients.
15944379|NCT03307863|Drug|Carbamazepine-Implant|Women with epilepsy using carbamazepine for at least 3 months will have an etonogestrel-releasing implant inserted
15944380|NCT03307863|Drug|Topiramate-Implant|Women with epilepsy using carbamazepine for at least 3 months will have an etonogestrel-releasing implant inserted
15944381|NCT03307863|Drug|Implant|Women without epilepsy and not using an anti-epileptic drug will have an etonogestrel-releasing implant inserted
15944409|NCT03307681|Other|Baked potato with skin|Baked russet potato with canola oil added once baked to match for fat content of French fries, and also matched for the salt content of white bread (280 milligrams).
15944506|NCT03306914|Drug|Albumin 5%|Infusion of Albumin 5% intra-operatively
15944382|NCT03307850|Other|Observation During Exercise and Stress|"Patients with type 1 diabetes (T1D) on an insulin pump will be studied for 5 weeks in the outpatient setting performing their normal activities, to include their normal diet and exercise, while assessing the amount of type of exercise performed, and emotional stress levels, using stress sensor, questionnaires and salivary cortisol levels.
~Subjects at the William Sansum Diabetes Center will perform graded exercise on a treadmill for up to 45 minutes with all activity and stress monitors running, achieving 30 and 60% calculated heart rate reserve, once during the study. Subjects at Mayo Clinic will perform a graded exercise test on a treadmill to determine V02max and ensure stable cardiac status, once during the study."
15944383|NCT03307837|Drug|CA-008|Local administration during surgery
15944384|NCT03307837|Drug|Placebo|Local administration during surgery
15944385|NCT03307824|Device|Synthetic glue IfabondTM|Use of the synthetic glue IfabondTM
15944386|NCT03307824|Procedure|Glue-Free Suture Technique|Suture Technique
15944387|NCT03307811|Other|22 gauge needle liver biopsy|EUS will be performed. Specimens obtained from each pass will be placed in a separate biopsy jar. If the third pass does not result in sufficient diagnostic material, a 19 G will be used. A maximum of 3 passes will be made using the alternate needle. The total number of passes with the 22 G needle and the 19 G needle is 6. Data will be collected about the procedure and the performance of the needles for each procedure.
15944388|NCT03307785|Drug|Niraparib|Niraparib is a potent, orally active PARP1 and PARP2 inhibitor being developed as a treatment for patients with tumors that harbor defects in the homologous recombination DNA repair pathway or that are driven by PARP-mediated transcription factors.
15944389|NCT03307785|Drug|TSR-042|TSR-042 is a humanized monoclonal antibody that binds with high affinity to PD-1 resulting in inhibition of binding to programmed death receptor ligands 1 and 2 (PD-L1 and PD-L2).
15944390|NCT03307785|Drug|Carboplatin-Paclitaxel|Carboplatin in combination with paclitaxel is a chemotherapy treatment that has been shown to be efficacious against a variety of different tumor types, including non-small cell lung cancer [NSCLC], ovarian cancer, endometrial cancer, and head and neck cancer.
15944391|NCT03307785|Drug|Bevacizumab|Bevacizumab is a chemotherapy treatment that has been shown to be efficacious against a variety of different cancer types, including colon cancer, lung cancer, glioblastoma, and renal-cell carcinoma. Bevacizumab is in the angiogenesis inhibitor and monoclonal antibody families of medication. It works by slowing the growth of new blood vessels.
15944392|NCT03307785|Drug|TSR-022|"TSR-022 is a monoclonal antibody against TIM-3 (also called HAVCR2), an immune checkpoint receptor. Immune checkpoint proteins are molecules that help to regulate the immune system so it does not mistakenly attack healthy cells. However, they can also keep immune cells from recognizing and killing cancer cells.
~TIM-3 is found on the surface of certain T-cells, including tumor-infiltrating T-cells, that have left the bloodstream and migrated into the tumor environment. By binding to and blocking TIM-3, TRS-022 allows for T-cells to become activated so as to enhance T-cell-mediated attacks on tumors. These attacks reduce their growth."
15944393|NCT03307785|Drug|Carboplatin-Pemetrexed|Pemetrexed and platinum therapy in combination with pembrolizumab (anti-PD-1 antibody) has proven to be efficacious in a first line setting for nonsquamous NSCLC patients
15944394|NCT03307785|Drug|Carboplatin-Nab-Paclitaxel|Nab-paclitaxel is a formulation of paclitaxel that is indicated for locally advanced or metastatic NSCLC, as first-line treatment in combination with carboplatin in patients who are not candidates for curative surgery or radiation therapy. Nab-paclitaxel has shown increased ORR and time to progression in metastatic breast cancer compared with solvent-based paclitaxel and has shown antitumor activity and improved ORR compared with solvent-based paclitaxel as first-line therapy in patients with NSCLC.
15944395|NCT03307772|Dietary Supplement|Probiotics|
15944396|NCT03307772|Dietary Supplement|Prebiotics|
15944397|NCT03307772|Dietary Supplement|Prebiotics and Probiotics|
15944398|NCT03307772|Dietary Supplement|Placebo|
15944399|NCT03307759|Drug|Pembrolizumab|Pembrolizumab
15944400|NCT03307759|Radiation|Radiotherapy (SABR)|Radiotherapy
15944401|NCT03307746|Drug|Varlilumab|"Rituximab is a so-called direct-targeting mAb, which binds to the CD20 molecule on the surface of normal and malignant B cells. The mAb then engages immune effectors cells, such as macrophages, through Fc:Fc gamma receptor interaction, leading to tumour cell killing by antibody directed cellular cytotoxicity and/or phagocytosis (ADCC/ADCP).
~Varlilumab (1F5, CDX-1127) is a recombinant and fully human IgG1kappa mAb that binds to human CD27 with high affinity (62). As far as we are aware, it is the only anti-CD27 mAb in clinical development. Once bound, varlilumab blocks CD70 binding to CD27."
15944402|NCT03307733|Behavioral|walking and behavour change techniques|a Fitbit pedometer with individualised step targets and partaking in a closed Facebook group
15944403|NCT03307720|Drug|Gonadotropin Releasing Hormone Agonists (GNRH-A)|Administration of a gonadotropin releasing hormone agonist (GnRH-a) (0,2 ml) subcutaneously, 36 hours before ovum pick-up in IVF treatments.
15944404|NCT03307720|Drug|Human chorionic gonadotropin|Administration of Human chorionic gonadotropin (HCG) 250 IU subcutaneously , 36 hours before ovum pick-up in IVF treatments.
15944405|NCT03307694|Diagnostic Test|Ultrasound|All ultrasound images will be acquired by an in-house ultrasound technologist using a Verasonics Vantage (Verasonics Inc., Kirkland, Washington, USA) ultrasound system. During imaging, the technologist will position the Verasonics transducer, under b-mode guidance, in planes overlying the thyroid nodules approximating those obtained during previous clinical ultrasound scans.
15944406|NCT03307694|Diagnostic Test|Shear wave elasticity imaging|"Shear wave elasticity imaging (SWEI) is obtained during the standard ultrasound session. The generation of shear wave images consists of two important steps called pushing and tracking. First, in the pushing mode, a long focused ultrasound beam is transmitted to perturb tissue, generating ultrasonic shear waves in tissue that propagate perpendicular to the direction of pushing. In the tracking mode, shear wave propagation is observed and recorded. Because the speed of shear waves is a function of Young's modulus, these data reveal information about the stiffness of underlying biological tissue."
15944407|NCT03307694|Diagnostic Test|Multi-angle compound shear wave elasticity imaging|The multi-angle compound SWEI (MAC-SWEI) algorithm, which generates shear images based on multiple angled push beams, has the potential to generate more accurate shear wave images in the context of thyroid imaging. To assess the MAC-SWEI technique, shear wave images will be used to generate estimates of the relative stiffness of lesions via their normalized Young's modulus.
15944410|NCT03307681|Other|Mashed potato served hot|Mashed potatoes prepared from frozen, with canola oil added to match for fat content of French fries, as well as being matched for energy and available carbohydrate content of the baked potato.
15944411|NCT03307681|Other|Fried French fries|Prepared from frozen, matched for energy and available carbohydrate content of baked potato and salt content of white bread.
15944412|NCT03307681|Other|Meal skipping|No food given
15944413|NCT03307668|Device|CaReSR-1S|CaReSR-1S is a sterile, ready for use round implant based on a dense matrix of native Collagen type I.
15944414|NCT03307668|Device|Microfracture|Microfracture is an articular cartilage repair surgical technique that works by creating tiny fractures in the underlying bone. This causes new cartilage to develop from a so-called super-clot.
15944415|NCT03307655|Other|Control (fertile semen donors)|"The sperm will be capacitated in the presence and absence of follicular fluid (FF). In a first set of experiments, the FF will be supplemented with L-Arginine and the NOS inhibitor L-NAME. In another set of experiments the same supplementations to the capacitation medium will be examined, but without using FF.
~Changes in NOS expression, protein nitrosylation, PKA activity, tyrosine phosphorylation and tyrosine nitration in sperm will be determined."
15944416|NCT03307655|Other|Patients (subfertile men)|"The sperm will be capacitated in the presence and absence of follicular fluid (FF). In a first set of experiments, the FF will be supplemented with L-Arginine and the NOS inhibitor L-NAME. In another set of experiments the same supplementations to the capacitation medium will be examined, but without using FF.
~Changes in NOS expression, protein nitrosylation, PKA activity, tyrosine phosphorylation and tyrosine nitration in sperm will be determined."
15944417|NCT03307642|Other|Text message notification|Three text messages will be sent to 50% of the parents, scheduled around the standard methods of communication
15944418|NCT03307629|Drug|NOX66|NOX66 delivered as rectal suppository.
15944419|NCT03307629|Radiation|Irradiation Therapy|Radiation per selected tumour lesion.
15944420|NCT03307616|Biological|Ipilimumab|Given IV
15944421|NCT03307616|Biological|Nivolumab|Given IV
15944422|NCT03307616|Radiation|Radiation Therapy|Undergo radiation therapy
15944423|NCT03307603|Radiation|yttrium-90 radioembolization|Yttrium-90 will be given as biocompatible resin-based microspheres and will be introduced to the tumor(s) on one side of the liver through a catheter placed in the right or left hepatic artery. The dose of radiation will be determined by a radiologist and will be based on body surface area and tumor burden.
15944424|NCT03307603|Drug|Phase Ib - nivolumab|240 mg intravenously
15944425|NCT03307603|Drug|Phase II - nivolumab|nivolumab will be administered as determined during the phase Ib portion of the study. Nivolumab will be administered on an every 2 week basis for a total of 48 weeks or until disease progression, unacceptable toxicity or discontinuation due to patient/physician preference.
15944426|NCT03307590|Drug|Dexmedetomidine|Caudal block by dexmedetomidine and bupivavaine
15944427|NCT03307590|Drug|Bupivacaine|Caudal block by bupivavaine alone
15944428|NCT03307577|Drug|UHE-101 Cream|Topical cream containing investigational drug at a concentration of 1%
15944429|NCT03307577|Other|Vehicle Cream|Topical cream containing no drug (i.e., placebo)
15944430|NCT03307564|Device|TraceIT tissue marker injection|The TraceIT injection will be performed during the endoscopic fiducial placement which is the standard of care. CTs to serially confirm TraceIT positioning will be performed on the same day during patient visits for their middle (2nd or 3rd fraction) and last (5th fraction) radiation therapy treatments.
15944431|NCT03307551|Drug|Propofol|Propofol delivery will be controlled using automated closed loop anaesthesia delivery system which will control propofol delivery rate to consistent anaesthetic depth (BIS-50) feedback from the patient (CLADS group)
15944432|NCT03307551|Drug|Propofol|Propofol delivery will be controlled using infusion pumps which will be manually controlled to deliver propofol to maintain consistent anaesthetic depth (BIS-50). (Manual group)
15944433|NCT03307538|Radiation|Stereotactic body radiation therapy|15 fractions of 3-4,5 Gy (risk-adapted)
15944434|NCT03307512|Drug|inhaled human insulin|Dance 501 (Human Insulin Inhalation Solution and Inhaler) will be administered by inhalation
15944435|NCT03307512|Drug|Insulin Lispro (Humalog U-100)|Insulin Lispro (Humalog U-100) will be administered by subcutaneous injection
15944436|NCT03307499|Other|NeoPatch|NeoPatch as an adjunct to foot and ankle tendon revision/repair surgery
15944437|NCT03307473|Behavioral|E6BIKE|During 3 months in a the geographic area of Clermont-Ferrand (France), new e-bike buyers and renters are invited to take part in VELONAPS study before starting to use their e-bike
15944438|NCT03307460|Drug|68Ga-NOTA-AE105|PET/MRI scan
15944439|NCT03307447|Drug|Secukinumab|Secukinumab 300 mg subcutaneous injection
15944440|NCT03307434|Other|Athletics Injury Prevention Program|The Athletics Injury Prevention Program (AIPP) will be performed by experimental group twice a week. The AIPP is composed of 8 exercises including core stability, balance, pelvic stabilization, stretching and strengthening of the Achilles tendon and hamstrings.
15944441|NCT03307434|Other|regular training|The regular training will be performed by control group according to the standard practice.
15944442|NCT03307421|Other|debriefing without instructor|"The randomization will focus on the allocation of the debriefing method: group without instructor versus group with instructor (AI). It will be stratified by center and performed before the first simulation session. The randomization will be carried out by the clinical methodology center of the Besançon University Hospital.
~The sequence of scenarios for each binomial will also be determined by randomization."
15944443|NCT03307421|Other|debriefing with instructor|The randomization will focus on the allocation of the debriefing method: group without instructor versus group with instructor (AI). It will be stratified by center and performed before the first simulation session. The randomization will be carried out by the clinical methodology center of the Besançon University Hospital.
15944444|NCT03307408|Other|blood collection|Standard routine practice clinico-biological data will be collected
15944445|NCT03307395|Procedure|Middel Meningeal Artery Embolization|Blood supply to the subdural hematoma via the middle meningeal artery is interrupted.
15944481|NCT03307083|Other|Check list FOR (Foundation for Oral Rehabilitation)|the surgeon uses this check list during the pre surgery consultation
15944507|NCT03306914|Drug|Hydroxyethylstarch 6%|Infusion of Hydroxyethylstarch 6% intra-operatively
15980642|NCT03032159|Behavioral|Text2Breathe Study Group|
15944446|NCT03307382|Device|SpyGlass DS Cholangioscopy|SpyGlass DS Cholangioscopy includes a 10 French diameter single use digital cholangioscope and a light source with the digital sensor. During ERCP with cholangioscopic exam, the cholangioscope would be first inserted through the working channel of the duodenoscope and subsequently passed into the bile duct for direct visualization of the bile duct mucosa. The visual impression (VI) of the biliary stricture will be assessed. Tissue acquisition of the biliary stricture will be performed by cholangioscopy directed biopsy (CDBx), and conventional brush cytology with or without intraductal biopsy.
15944447|NCT03307356|Other|Uterine Transplant|Transplant of a uterus from a donor, deceased or living
15944448|NCT03307343|Behavioral|Intervention|The intervention will be delivered by trained research staff who are exercise physiologists or behavioral lifestyle counselors. This target reflects a recent expert statement concluding that desk-based workers should reduce workday sedentary behavior by 2-4 hr (by increasing standing and movement). The approach will combine: behavioral strategies (self-monitoring, goal setting, problem solving, social support, stimulus control), environment modification (sit-stand attachment), and proximal (activity prompter) and distal (text messages) external prompts. The initial in-person session will occur at the participant's office location. During months 2 and 3, one-on-one in-person meetings will occur at the research lab. Telephone intervention contacts will occur in the 3rd week of months 1-3.
15944449|NCT03307278|Biological|House dust mite|As a stimulant to induce inflammasome activation
15944450|NCT03307265|Device|Personalized weighted jacket|Patients in this group will wear a jacket with weights (1,5 to 2% of the total body mass) strategically placed in order to correct their imbalance.
15944451|NCT03307265|Device|Control jacket|Patients in this group will wear a jacket with weights (200 grams maximum) evenly distributed.
15944452|NCT03307252|Drug|Digoxin|Tablet
15944453|NCT03307252|Drug|Furosemide|Oral solution
15944454|NCT03307252|Drug|Metformin|Oral solution
15944455|NCT03307252|Drug|Rosuvastatin|Film-coated tablet
15944456|NCT03307252|Drug|Verapamil|Film-coated tablet
15944457|NCT03307252|Drug|Rifampin|Film-coated tablet
15944458|NCT03307252|Drug|Cimetidine|Tablet
15944459|NCT03307252|Drug|Probenecid|Tablet
15944460|NCT03307239|Other|cold application|"We manufactured two ice packs (17 × 12 cm) with a combined weight of 600 g. The ice packs were inserted into adjustable wraps made in our hospital so that they can be fixed next to the skin on each side of the chest tube in patients awaiting CTR. The combined contact area of the ice packs was approximately 25 cm in diameter around the chest tube.
~For patients of the experimental group, they were received 15-minutes cold application."
15944461|NCT03307239|Other|tap water packs application|"We manufactured two tap water packs (17 × 12 cm) with a combined weight of 600 g. The tap water packs were inserted into adjustable wraps made in our hospital so that they can be fixed next to the skin on each side of the chest tube in patients awaiting CTR. The combined contact area of the tap water packs was approximately 25 cm in diameter around the chest tube.
~For patients of the sham group, they were received 15-minutes tap water application."
15944462|NCT03307226|Behavioral|Youth Development Accounts (YDA)|Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development Financial workshops on asset-building, saving and investing in Income Generating Activities (IGAs) Behavioral: Youth Development Accounts (YDA)
15944463|NCT03307226|Behavioral|YDA + Multiple Family Groups (MFG)|Youth Development Accounts (YDA) with 1:1 incentive match rate to be used for education and microenterprise development 12 Financial Management workshops on asset-building, saving and investing in Income Generating Activities (IGAs) 18 Multiple Family Groups sessions focused on strengthening family relationships and mental health
15944464|NCT03307213|Device|BioFreedom™ CoCr Biolimus A9™ stent|Stent implantation
15944465|NCT03307213|Device|BioFreedom™ SS Biolimus A9™ stent|Stent implantation
15944466|NCT03307187|Behavioral|GLB Adapted for Individuals with Impaired Mobility|The 12-month Group Lifestyle Balance program, Adapted for individuals with Impaired Mobility (GLB-AIM) promotes 5% - 7% weight loss by reducing calories and increasing energy expenditure to 150 minutes of weekly activity. The 23 GLB-AIM sessions were delivered through monthly in-person and teleconference calls. Participants were encouraged to self-monitor daily caloric/fat intake and physical activity using materials to accurately measure daily calories and exercise, which included a food scale, measuring cups and spoons and a loaned Garmin vívofit® activity tracker and heart rate monitor. Participants shared their logs with lifestyle coaches over the 13 core sessions and lifestyle coaches provided positive reinforcement, feedback, and problem solving techniques as needed.
15944467|NCT03307174|Drug|Bupivacaine|
15944468|NCT03307174|Drug|Fentanyl|
15944469|NCT03307161|Other|osteopathic manual therapy|Investigators board certified in osteopathic manual therapy will use their hands in a non-invasive manner to improve dystonia symptoms
15944470|NCT03307148|Drug|ATRA|Administered orally on D1-15 of each 28 day cycle.
15944471|NCT03307148|Drug|Gemcitabine|Intravenous Infusion on D1,8 and 15 of each 28 day cycle.
15944472|NCT03307148|Drug|Nab-paclitaxel|Intravenous Infusion on D1,8 and 15 of each 28 day cycle.
15944473|NCT03307135|Device|single assessment with the MSPMI|Manually applied stretch with the MSPMI installed on the foot and shank at 3 different velocities on 2 positions (knee flexed and extended)
15944474|NCT03307135|Device|double assessment with the MSPMI with 7 days of interval|Manually applied stretch with the MSPMI installed on the foot and shank at 3 different velocities on 2 positions (knee flexed and extended)
15944475|NCT03307135|Device|double assessment with the MSPMI before and after treatment|Manually applied stretch with the MSPMI installed on the foot and shank at 3 different velocities on 2 positions (knee flexed and extended)
15944476|NCT03307122|Other|Routine Infant Formula 1|Routine infant formula with probiotic
15944477|NCT03307122|Other|Routine Infant Formula 2|Routine infant formula with probiotic and prebiotic
15944478|NCT03307109|Other|Quality of life|Patients will complete two EQ-5D-5L and EQ-5D-3L quality of life questionnaires and will complete an analog visual scale during each of their follow-up visits to the Infectious and Tropical Diseases Department of Croix-Rousse hospital. No visits will be added to complete the questionnaires.
15944479|NCT03307096|Procedure|Microperc surgery|Parents are treated by Microperc Percutaneous Nephrolithotomy
15944480|NCT03307096|Procedure|FURS|Parents are treated by FURS
15944482|NCT03307070|Behavioral|Cognitive Behavioral Therapy for individuals with TBI|Cognitive Behavioral Therapy for depression that has been adapted for a population who has experienced a moderate to severe Traumatic Brain Injury. This is a 12 week long treatment for depression with weekly visits that challenges negative thoughts and behaviors. This version has been specifically developed for the study to account for specific cognitive needs of individuals who have experienced a moderate to severe TBI.
15944483|NCT03307070|Other|Waitlist Control|Participants will be randomized to a waitlist. They will attend biweekly study sessions for 12 weeks to track progress, but will receive their treatment as usual.
15944484|NCT03307057|Behavioral|Social Communication Growth Charts (SCGC)|The Social Communication Growth Charts (SCGC) is a web-based tool that parents can access to teach them the social communication milestones that are developing from 6 to 24 months of age. The SCGC has an explore function with hundreds of video clips illustrating 80 social communication milestones and a support video that has narration explaining how the parent in the video is supporting the child's development. The SCGC also has a charting function that parents can use by answering questions about their child's social communication milestones and then view charts in 5 developmental domains. Parents in the SCGC condition are also invited to a bi-weekly online Guided Tour to join other parents in a group meeting, like a book club, as they go through the SCGC.
15944485|NCT03307057|Behavioral|Parent-Implemented (P-I) Condition|"The Parent-Implemented (P-I) condition is based on the Early Social Interaction (ESI) model, which is an evidence-based parent-implemented intervention involving active and productive engagement for 5 hours per day, 5 days per week for toddlers with ASD. ESI teaches parents how to support their child's social communication, language, play and behaviors in everyday routines, activities, and places.
~Weekly home sessions with a family navigator include:
~developing the visit agenda
~intervention implementation including: guided/caregiver practice, feedback and problem solving
~planning for parent implementation between sessions
~Families can also access the Autism Navigator How-To Guide for Families (a self-guided, web-based course), the Online Guided Tour for the How-To Guide (an online group to engage families), and have the opportunity to interact with other families who suspect their child has autism through audio or video conferencing or typed chat."
15944486|NCT03307057|Behavioral|Clinician-Implemented (C-I) Condition|The Clinician-Implemented (C-I) condition is based on the core principles of empirically-supported naturalistic developmental behavioral interventions (NDBI) for infants and toddlers with or at-risk for ASD, including Early Start Denver Model (ESDM), Project ImPACT (Improving Parents As Communication Teachers), Pivotal Response Treatment (PRT), and Early Social Interaction (ESI). The goal of C-I NDBI is to use naturalistic, developmental, and behavioral strategies with infants at-risk for ASD to improve social-communication, which includes eye contact, gesture use, intentional vocalizations, and language. Parents are not actively involved in C-I NDBI intervention sessions, though they may observe and the clinician will be given information about current social-communication targets.
15944487|NCT03307044|Procedure|Laser Therapy|Undergo fractional CO2 laser therapy
15944488|NCT03307044|Other|Questionnaire Administration|Ancillary studies
15944489|NCT03307031|Other|High Volume Group|Performed four weekly session, during 10 weeks with 45 to 55 minutes per session.
15944490|NCT03307031|Other|Low Volume Group|Performed only twice a week, during 10 weeks with 45 to 55 minutes per session.
15944491|NCT03307031|Other|Control Group|Did not exercise, during 10 weeks.
15944492|NCT03307018|Procedure|Postoperative systematic bronchial aspiration.|Postoperative flexible bronchoscopy and systematic bronchial aspiration.
15944493|NCT03307005|Drug|Zolpidem Tartrate|Zolpidem tartrate 5 mg capsule one per night taken for 7 nights
15944494|NCT03307005|Drug|Placebo oral capsule|Placebo capsule one per night taken for 7 nights
15944495|NCT03306992|Behavioral|Personalized Exercise Program|"The PEP intervention involves a combination of home-based exercise as well as in-patient exercise. The exercise modes will include basic transfer and calisthenics mobility, aerobic and resistance exercises and will be performed in various postures (supine, sitting, standing and walking) with variable challenges (level walking, bending, inclines, steps and squatting).
~For patients randomized to the Intervention Group (Group 1), the PEP intervention will be personalized, implemented, and modified (based on the patients AM-PAC mobility stage) by a licensed physical therapist in face-to-face, virtual, or phone meetings (~30-40 minutes). An exercise education manual, specifically developed for this study, will be used by the physical therapist to educate the patients on all aspects of starting and maintaining the exercise intervention."
15944496|NCT03306979|Drug|N Acetylcysteine|Patients will be randomized to receive N Acetylcysteine (NAC) (four 600 mg capsules given as 2 capsules in the morning and 2 capsules in the evening). The initial NAC dosage will be 600mg/day (one 600mg capsule in the morning) for the first week, followed by 1,200 mg/day (one 600 mg capsule in the morning, one 600mg capsule in the evening) for the second week, followed by 1,800 mg/day (two 600mg capsules in the morning, one 600mg capsule in the evening) for third week, followed by 2,400mg/day (two 600mg capsules in the morning, two 600mg capsules in the evening) for the following 21 weeks.
15944497|NCT03306979|Other|Placebo oral capsule|Patients will receive four placebo capsules (lactose-based filler) given as 2 capsules in the morning and 2 capsules in the evening, which will be prepared to mimic the weight of the experimental capsules.The initial placebo dosage will be 600mg/day (one 600mg capsule in the morning) for the first week, followed by 1,200 mg/day (one 600 mg capsule in the morning, one 600mg capsule in the evening) for the second week, followed by 1,800 mg/day (two 600mg capsules in the morning, one 600mg capsule in the evening) for third week, followed by 2,400mg/day (two 600mg capsules in the morning, two 600mg capsules in the evening) for the following 21 weeks.
15944498|NCT03306966|Device|Endoscopic Linear Cutter Stapler and Reloads (Frankenman)|The Single Use Endoscopic Linear Cutter Stapler and Reloads from Frankenman received CE-mark in April 2013. It is used to staple and simultaneously divide tissue from the central line.
15944499|NCT03306953|Procedure|Rectus muscle approximation|The surgeon will take sutures to approximate rectus muscles at the end of cesarean delivery.
15944500|NCT03306940|Drug|Botulinum Toxin Type A|patients were injected to the normal side with dose of 1.25 units/per site
15944501|NCT03306927|Dietary Supplement|Whole yellow pea chili|Chili containing whole yellow peas
15944502|NCT03306927|Dietary Supplement|Split yellow pea chili|Chili containing split yellow peas
15944503|NCT03306927|Dietary Supplement|Rice chili|Chili containing long grain white rice
15944504|NCT03306914|Other|Albumin resuscitation|Albumin 5% is used as the intra-operative colloid
15944508|NCT03306901|Procedure|Esophagectomy|Ivor Lewis esophagectomy or McKeown esophagectomy and systematic lymphadenectomy
15944509|NCT03306901|Drug|5-fluorouracil|3,200 ~ 4,000mg/m2 intravenously for 4 to 5 days.
15944510|NCT03306901|Drug|Cisplatin|45~60mg intravenously over 1 hour on day 1
15944511|NCT03306901|Radiation|Radiation therapy|45 Gy irradiation (5 days a week for 5 weeks)
15944512|NCT03306888|Other|Physical Activity Coaching|Physical activity coaching over 4 months
15944513|NCT03306875|Behavioral|Cognitive Training|Individuals will take part in a computer-based cognitive training program. The program is aimed at building attention, processing speed, memory, and executive function.
15944514|NCT03306862|Dietary Supplement|Whole yellow pea soup|Soup containing whole yellow peas
15944515|NCT03306862|Dietary Supplement|Split yellow pea soup|Soup containing split yellow peas
15944516|NCT03306862|Dietary Supplement|Potato soup|Soup containing potatoes
15944517|NCT03306836|Drug|Heparin Sodium|Infused with 5000 IU of Heparin Sodium
15944518|NCT03306836|Drug|Heparin Sodium|Infusion Heparin Sodium at a rate of 18 IU / kg.h
15944519|NCT03306810|Other|AG service|The AG service group is divided to two 200 patients groups: 1) with AGS 2) with AGS extended to first control in 3 months (AG- nurse may be contacted by phone). Patients are followed up up to 5 years.
15944520|NCT03306797|Other|STANDARD REHAB|"The rehabilitative standard intervention (Occupational Therapy) consists of 15 minutes of warm-up exercises plus a 20 minutes training with at least 6 exercises selected from:
~wrist
~ulnarization radialization
~prono-supination
~horizontal flexion-extension
~vertical flexion-extension hand
~grasping
~pinching
~extensors
~interosseous shoulder-elbow
~vertical flexion-extension
~push forward"
15944521|NCT03306797|Device|SONICHAND|"The intervention is similar to the standard protocol (15 minutes of warm-up plus 20 minute of training) but involves the sonification of the exercises selected from the list. The Leap Motion Controller is managed with an ad-hoc developed application that is able to associate the movements with a 4 notes arpeggio or with a modulated texture.
~With the first mode the movement produces and modulates an harmonic progression built on the consecutive grades of the major scale played as ascending and descending arpeggio with also a volume crescendo and decrescendo.
~With the second mode, the movement modulates the volume and the low-pass cutoff frequency of a synthetic texture."
15944522|NCT03306784|Other|questionnaires|questionnaires, including RAPID3 and pain catastrophizing scales
15944523|NCT03306771|Diagnostic Test|Ultrasound Duplex|The two groups will have Ultrasound Duplex before bariatric surgery, and 6,12 and 24 months post surgery
15944524|NCT03306758|Drug|Sodium Bicarbonate|Sodium Bicarbonate was given 1g tid for one month
15944525|NCT03306745|Dietary Supplement|Profertil female|"For micronutrient ingredients please see details above. PROfertil ® female is approved in Austria by the Austrian Ministry of Health and has a Free Sales Certificate."
15944526|NCT03306745|Dietary Supplement|Folic acid 400 mg|Folic acid 400 mg
15944527|NCT03306732|Drug|Thiamine hydrochloride (200mg) dissolved in 100 ml of normal saline|"After anesthesia induction
~After separation from CPB
~On the evening of the day of surgery (22:00)
~On POD 1 twice a day at 8:00 and 22:00
~On POD 2 twice a day at 8:00 and 22:00 (if patient is still in ICU)
~On POD 3 twice a day at 8:00 and 22:00 (if patient is still in ICU)"
15944528|NCT03306732|Drug|Normal saline (100ml)|"After anesthesia induction
~After separation from CPB
~On the evening of the day of surgery (22:00)
~On POD 1 twice a day at 8:00 and 22:00
~On POD 2 twice a day at 8:00 and 22:00 (if patient is still in ICU)
~On POD 3 twice a day at 8:00 and 22:00 (if patient is still in ICU)"
15944529|NCT03306719|Biological|Blood sampling|Serial blood sampling
15944533|NCT03306693|Behavioral|Emotional skills|2-hour 3 group sessions
15944534|NCT03306693|Behavioral|Relaxation and talking group|2-hour 3 group sessions
15944535|NCT03306680|Radiation|SBRT|Patients will be assigned to treatment doses using the TITE-CRM model.
15944536|NCT03306667|Drug|FYU-981|Oral single dosing
15944537|NCT03306654|Behavioral|Happify|An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction.
15944538|NCT03306641|Device|Test Contact Lens|Daily disposable contact lens
15944539|NCT03306641|Device|Nelfilcon A|Focus Dailies All Day Comfort contact lens (nelfilcon A)
15944540|NCT03306628|Other|CO2 Laser Administration|The CO2 fractional laser system will be applied at a pulse energy setting of 50 millijoules and a density of 100 spots/cm2 on one of the breast incisions (either one week after surgery or six weeks after surgery, depending on the randomization group).
15944543|NCT03306602|Device|Filtek Bulk Fill Posterior Restorative|Filtek™ Bulk Fill Posterior Restorative is a one-step bulk placement solution for fast and easy posterior resin restorations.
15944544|NCT03306602|Device|Filtek Z350 XT|Filtek Z350XT is a material for incremental layered composite resin restorations
15944545|NCT03306589|Biological|Cantharidin|5 microliter (µL) of 0.2 percent Cantharidin solution (diluted in acetone) will be applied to all subjects on forearm by topical route.
15944546|NCT03306589|Biological|Lipopolysaccharide|0.5 to 4 ng/kg body weight of LPS formulated as suspension in normal saline will be administered to randomized subjects via intravenous (IV) route in dose-escalation manner.
15944547|NCT03306589|Biological|Granulocyte-Macrophage Colony-Stimulating Factor|5 to 15 µg/kg of GM-CSF will be administered to randomized subjects via subcutaneous (SC) route in the abdominal region in dose-escalation manner.
15944577|NCT03306381|Other|Dietary intervention|Elimination of certain products.
15945716|NCT03297489|Procedure|Diagnostic Microscopy|Undergo observation via intravital microscopy
15944548|NCT03306589|Drug|Saline Solution|0.9 percent sodium chloride will be administered via IV route to all subjects at a rate of 250 mL/hour for 4 hours prior to dosing with LPS and 8 hours after dosing with LPS.
15944549|NCT03306576|Device|ELS Extra composite|One of the teeth will be restored using ELS composite. Procedures will be done under local anesthesia if necessary. The preparation and restoration of the tooth will be done according to to the guidelines for ordinary restorative techniques.
15944550|NCT03306576|Device|ELS composite|the other teeth will be restored with a ELS resin composite with ordinary restorative techniques.
15944551|NCT03306563|Diagnostic Test|Sample collection|Samples of blood, urine and saliva will be collected at up to five successive time points.
15944552|NCT03306550|Drug|salvianolate injection|The main ingredient of salvianolate injection is salvianolic acid B(SAB) which is extracted from the root of red salvia. Red salvia is used in traditional Chinese Medicine. It could promote blood circulation to removing blood stasis,which is clinically effective in treatment for cardiovascular disease.
15944553|NCT03306550|Drug|Aspirin Tablet|Anti-platelet medicine treatment and Chinese traditional medicine (TCM) promoting blood circulation to removing blood stasis is widely used in treatment for cardiovascular disease.
15944554|NCT03306537|Device|RespiraSense Respiratory Rate Monitor|RespiraSense device will be attached at the same time as the capnograph (gold standard) and both will measure simultaneously for one hour
15944555|NCT03306524|Device|SIPPV_VG_0_08|Mechanical ventilation using SIPPV-VG ventilator mode with a slope time of 0.08 seconds, inspiratory time of 0.40 seconds for 15 minutes
15944556|NCT03306524|Device|SIPPV_VG_0_16|Mechanical ventilation using SIPPV-VG ventilator mode with a slope time of 0.16seconds, inspiratory time of 0.40 seconds for 15 minutes
15944557|NCT03306524|Device|SIPPV_VG_0_24|Mechanical ventilation using SIPPV-VG ventilator mode with a slope time of 0.24 seconds, inspiratory time of 0.40 seconds for 15 minutes
15944558|NCT03306524|Device|SIPPV_VG_0_32|Mechanical ventilation using SIPPV-VG ventilator mode with a slope time of 0.32 seconds, inspiratory time of 0.40 seconds for 15 minutes
15944559|NCT03306524|Device|SIPPV_VG_0_40|Mechanical ventilation using SIPPV-VG ventilator mode with a slope time of 0.40 seconds, inspiratory time of 0.40 seconds for 15 minutes
15944560|NCT03306524|Device|PSV_VG_0_08|Mechanical ventilation using PSV-VG ventilator mode with a slope time of 0.08 seconds, maximum inspiratory time of 0.60 seconds for 15 minutes
15944561|NCT03306524|Device|PSV_VG_0_16|Mechanical ventilation using PSV-VG ventilator mode with a slope time of 0.16 seconds, maximum inspiratory time of 0.60 seconds for 15 minutes
15944562|NCT03306524|Device|PSV_VG_0_24|Mechanical ventilation using PSV-VG ventilator mode with a slope time of 0.24 seconds, maximum inspiratory time of 0.60 seconds for 15 minutes
15944563|NCT03306524|Device|PSV_VG_0_32|Mechanical ventilation using PSV-VG ventilator mode with a slope time of 0.32 seconds, maximum inspiratory time of 0.60 seconds for 15 minutes
15944564|NCT03306524|Device|PSV_VG_0_40|Mechanical ventilation using PSV-VG ventilator mode with a slope time of 0.40 seconds, maximum inspiratory time of 0.60 seconds for 15 minutes
15944565|NCT03306511|Other|Repeated-sprint test|6x30-meter sprint interspersed with 90-s rest
15944566|NCT03306498|Drug|Aminoleban (8% amino acids infusion)|Each 1000ml of AMINOLEBAN contains: Aminoacetic acid - 9.0 g L-alanine -- 7.5 g L-arginine Hydrochloride (HCl) -- 7.3 g (L-arginine equivalent) -- (6.0 g) L-cysteine HCl monohydrate -- 0.4 g (L-cysteine equivalent) -- (0.3 g) L-histidine HCl monohydrate -- 3.2 g (L-histidine equivalent)-- (2.4 g) L-isoleucine -- 9.0 g L-leucine -- 11.0 g L-Lysine HCl -- 7.6 g (L-lysine equivalent) -- (6.1 g) L-methionine -- 1.0 g L-phenylalanine -- 1.0 g L-proline -- 8.0 g L-serine -- 5.0 g L-threonine -- 4.5 g L-tryptophan -- 0.7 g L-valine -- 8.4 g Water for injection q.s -- 1000 m
15944567|NCT03306485|Other|Correlating the number of reflux episodes detected on 1-h post prandial esophageal high resolution manometry combined and those detected on ambulatory 24-h pH-impedance monitoring performed on PPI|Esophageal high resolution impedance manometry (HRIM) consists of introducing a transnasal probe to record esophageal contractility (manometry), bolus transit (impedance) but also the occurrence of reflux episodes. Ambulatory 24-h pH-impedance monitoring consists of recording the occurrence of reflux episodes by introducing a transnasal catheter into the esophagus. After inserting the transnasal HRIM probe and the pH-impedance catheter, both HRIM and 24-h pH-impedance recordings are started. The patient is instructed to eat a meal that induces reflux symptoms (the patient brings his own meal). One hour the end of the meal, the HRIM probe is removed. The patient is discharged at home and the 24-h pH-impedance monitoring is continued. The patient is coming back 24-h after catheter insertion to stop the pH-impedance recording and remove the catheter.
15944568|NCT03306472|Drug|Megestrol Acetate 40 MG|Progesterone Agonist
15944569|NCT03306472|Drug|Megestrol Acetate 160 MG|Progesterone Agonist
15944570|NCT03306472|Drug|Letrozole|Aromatase Inhibitor
15944571|NCT03306459|Diagnostic Test|SF-36 (Short Form Health Survey)|"Symptom Checklist-90-Revision (SCL-90-R): self-report questionnaire of 90 items on a 5-point Likert scale clustered in 9 primary scales (somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation and psychoticism).
~State-Trait-Anger-Expression-Inventory, version 2 (STAXI-2): self-report questionnaire of 57-items on a 4-point scale distributed in different dimensions: State-Anger, Trait-Anger Expression Anger (in-out) and Anger Control (in-out) Short Form Health Survey (SF-36), an instrument composed by 8 subscales: Physical Functioning, Physical Role Function, Bodily Pain, General Health, Vitality, Social Functioning, Emotional Role Function and Mental Health.
~Female Sexual Function Index (FSFI) a 19-item self-report measure of female sexual function providing scores on 6 domains (desire, arousal, lubrication, orgasm, satisfaction, pain) as well as a total score."
15944572|NCT03306446|Drug|Start adalimumab in monotherapy|Discontinuation of Adalimumab in patients who achieved deep remission
15944573|NCT03306433|Device|UDMA-K18 smooth surface sealant|The K18 as part of the UDMA polymer network (UDMA-K18) is hypothesized to prevent microbial attachment to the surface.
15944574|NCT03306420|Drug|M4112|All participants who received M4112 100,200,400,600 and 800 mg twice daily in 28-day cycles, starting from Day 1 of each cycle until confirmed disease progression or unacceptable toxicity (up to 15 Months).
15944575|NCT03306407|Other|Improved hand hygiene|The intervention group receives pre-travel advice with a special focus on improved hand hygiene including the use of hand gel sanitizer (Hartmann Sterillium) (bundle intervention)
15944576|NCT03306394|Drug|Trifluridine/Tipiracil hydrochloride (S95005)|
15944578|NCT03306368|Behavioral|Youth Opioid Recovery Support|"The components of the Youth Opioid Recovery Support intervention are:
~XR-NTX, home delivery of XR-NTX, the family framework approach engages and empowers families, assertive continuing care incorporates outreach, home delivery of XR-NTX, contingency management."
15944579|NCT03306355|Device|IOL implantation experimental|Implantation of trifocal IOL POD F GF consisting of hydrophobic material
15944580|NCT03306355|Device|IOL implantation active comparator|Implantation of trifocal IOL POD F consisting of hydrophilic material
15944581|NCT03306342|Device|IOL implantation experimental|Implantation of trifocal IOL POD F GF consisting of hydrophobic material
15944582|NCT03306329|Drug|DNS-7801 (low-dose)|DNS-7801 (low-dose) tablets administered once daily.
15944583|NCT03306329|Drug|DNS-7801 (high dose)|DNS-7801 (high dose) tablets administered once daily.
15944584|NCT03306329|Drug|Placebo|Placebo tablets administered once daily
15944585|NCT03306316|Dietary Supplement|Prebiotic|Prebiotic experimental group
15944586|NCT03306316|Dietary Supplement|Dextrose Control|Dextrose Control
15944587|NCT03306290|Drug|Serum dosage of antibiotic prophylaxis CEFOXITIN|"Three blood samples will be collected. These samples are specific for the research, and will be performed on the forearm opposite to the one used for Cefoxitin infusion.
~Blood sample at the start of surgery (t0): at the end of the Cefoxitin infusion (~30 min), 1 tube (5 ml) of blood will be withdrawn
~Blood sample at half way surgery (t1): 1 tube (5 ml) of blood will be withdrawn (if applicable)
~Blood sample at skin closure (t2): 1 tube (5 ml) of blood will be withdrawn"
15944588|NCT03306277|Biological|Onasemnogene Abeparvovec-xioi|Non-replicating recombinant adeno-associated virus serotype 9 (AAV9) containing the complimentary deoxyribonucleic acid (cDNA) of the human SMN gene under the control of the cytomegalovirus (CMV) enhancer/chicken-β-actin-hybrid promoter (CB). The AAV inverted terminal repeat (ITR) has been modified to promote intramolecular annealing of the transgene, thus forming a double-stranded transgene ready for transcription.
15944589|NCT03306264|Drug|ASTX727|ASTX727 is a tablet for oral administration, containing the fixed-dose combination of 100 mg cedazuridine (a cytidine deaminase inhibitor) and 35 mg decitabine, given by mouth Dailyx5 in 28-day cycles (in Cycle 1 or Cycle 2, then in Cycle 3 and beyond).
15944590|NCT03306264|Drug|Dacogen|Decitabine 20 mg/m^2 one-hour IV infusion Dailyx5 (in one 28-day cycle: either Cycle 1 or Cycle 2).
15944591|NCT03306238|Procedure|Open approach to port insertion|This involves the peritoneum being cut down, followed by the insertion of a blunt trocar under direct visualisation, gas insufflation, and insertion of the laparoscope
15944592|NCT03306238|Procedure|Closed approach to port insertion|This involves the insertion of a Veress needle (a needle equipped with a spring-loaded obturator) into the peritoneal cavity, followed by gas insufflation (act of blowing) and insertion of a trocar (a sharp, pointed instrument with a cannula used to enter the body cavity).
15944593|NCT03306212|Drug|Botulinum toxin A|
15944594|NCT03306212|Other|Occupational Therapy|
15944595|NCT03306212|Other|Intermittent serial casting|
15944596|NCT03306199|Device|Laser Atherectomy|The Turbo-Power is a laser atherectomy catheter designed for treatment of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents with adjunctive percutaneous transluminal angioplasty (PTA).
15944597|NCT03306186|Device|HemoSpec|Blood sampling for analysis
15944598|NCT03306173|Other|Commercially available cigarette|Commercially available cigarette with either ~0% or ~25% filter ventilation. Menthol flavor will be available in both types.
15944599|NCT03306160|Other|48-hour blood pressure ambulatory monitoring|at first-time dialysis after enrollment, each patient will receive brachial and central blood pressure monitoring for 48 hours using a validate and commercially available device Mobil-O-Graph (IEM, Germany).
15944600|NCT03306147|Behavioral|Pain education with follow up encounters|Patient pain review, counseling and education by pharmacists and physicians in follow up encounters
15944601|NCT03306134|Diagnostic Test|Dysphagia|"An overall assessment is going to be carry out by a multidisciplinary team during the visit.
~Swallowing assessment is going to be performed during the visit. We are going to use: (i) the Eating Assessment Tool (EAT-10), which is a short 10-item, easy to use, self-administered questionnaire [4]. Although the EAT-10 is considered to be predominantly a questionnaire on FHS, some items on HR-QoL are also included. The sum score of this 10-item questionnaire ranges from 0 to 40, and (ii) the Sydney Swallowing Questionnaire (SSQ) to clinically assess the severity of the symptoms of dysphagia, if present.
~All subjects are going to be submitted to the volume-viscosity swallow test (V- VST)"
15944602|NCT03306121|Drug|TPF+CCRT|"Patients receive paclitaxel liposome (135mg/m2 on day 1) , cisplatin (25mg/m2 on day 1-3) and 5-fluorouracil (750mg/m2 civ 120h) every three weeks for three cycles of induction chemotherapy before radiotherapy.
~Patients receive IMRT and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy (D1,D22,D43 of RT)"
15944603|NCT03306121|Drug|CCRT+ PF|"Patients receive cisplatin (80mg/m2 on day 1) and 5-fluorouracil (1000mg/m2 civ 96h) every four weeks for three cycles 4 weeks after radiotherapy.
~Patients receive IMRT and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy (D1,D22,D43 of RT)"
15944604|NCT03306108|Device|NRT|NRTratio is based on each individual electrode's ECAP threshold and can identify the intracochlear electrode array position in perimodiolar electrodes. The NRT-ratio showed a good reliability for the determination of the intracochlear electrode array position compared to the radiologic control intraoperatively Calculation of the NRT-ratio is done by dividing the arithmetic average of the t-NRT values from the apical electrodes 16 to 18 divided by the arithmetic average of the basal t-NRT from electrodes 5 to 7. With a NRT-ratio above 1.05, a high chance of a scalar change was rather likely, and a NRT-ratio below 1.05 was associated with a high chance of an electrode array position within the scala tympani.
15944605|NCT03306095|Other|Early refeeding group|Food Intake by patient with in 4 hours i.e <4 hours after the EVL procedure
15944606|NCT03306095|Other|Delayed refeeding group|Food Intake by patient after 4 hours i.e > 4 hours after the EVL procedure
15944607|NCT03306082|Other|Image-Guided Cochlear Implant Programming|Post Cochlear Implant surgery, participant will receive traditional activation and programming per routine. IGCIP will be used to offer alternative programming of the implant.
15944608|NCT03306069|Other|Control|Individualized, weight-reducing nutritional therapy and counseling, during a study period of 12 weeks
15945717|NCT03297489|Drug|Fluorescein Sodium Injection|Given IV
15944609|NCT03306069|Other|HIIT|"Procedures: Nutritional therapy (individualized, weightreducing nutritional therapy and counseling) during a study period of 12 weeks combined with supervised ergometer-based high-intensity interval training (HIIT).
~HIIT:
~2 sessions per week
~5x1 min at 80-95% HRmax
~time-effort per week: ~30 min"
15944610|NCT03306069|Other|MIIT-HR|"Procedures: Nutritional therapy (individualized, weightreducing nutritional therapy and counseling) during a study period of 12 weeks combined with supervised ergometer-based moderate-intensity interval training on the basis of HRmax (MIIT-HR).
~MIIT-HR:
~2 sessions per week
~5x1 min at 65-79% HRmax
~time-effort per week: ~30 min"
15944611|NCT03306069|Other|MIIT-LT|"Procedures: Nutritional therapy (individualized, weightreducing nutritional therapy and counseling) during a study period of 12 weeks combined with supervised ergometer-based moderate-intensity interval training on the basis of lactate threshold (MIIT-LT).
~MIIT-LT:
~2 sessions per week
~session 1: 2x4 min / session 2: 5x1 min, each at 105% LT
~time-effort per week: ~30 min"
15944612|NCT03306056|Other|Control|Individualized, weight-reducing nutritional therapy and counseling, during a study period of 12 weeks
15944613|NCT03306056|Other|Standard Strength Training|"Procedures: Nutritional therapy (individualized, weight-reducing nutritional therapy and counseling) during a study period of 12 weeks combined with a standard strength training program:
~5 strength training exercises (chest, upper/lower back, abdominals, legs)
~3 sets per exercise
~time-effort per session: ~90 min
~2 training sessions per week
~duration of exercise intervention: 12 weeks"
15944614|NCT03306056|Other|Low-volume Strength Training|"Procedures: Nutritional therapy (individualized, weight-reducing nutritional therapy and counseling) during a study period of 12 weeks combined a low-volume strength training program:
~5 strength training exercises (chest, upper/lower back, abdominals, legs)
~1 set per exercise
~time-effort per session: ~20 min
~2 training sessions per week
~duration of exercise intervention: 12 weeks"
15944615|NCT03306056|Other|Whole-Body Electromyostimulation (WB-EMS)|"Procedures: Nutritional therapy (individualized, weight-reducing nutritional therapy and counseling) during a study period of 12 weeks combined with WB-EMS:
~time-effort per session: ~20 min
~duration of exercise intervention: 12 weeks"
15944616|NCT03306043|Drug|Mepolizumab|Mepolizumab will be available as 100 mg vial for injection. Subjects will receive three 100 mg SC injections for every 4 Weeks for a total of 5 doses during 20 Week treatment period.
15944617|NCT03306030|Drug|Split dose of 4L PEG|All patients were given oral instruction for bowel preparation on the day of appointment and re-instruction through phone call on two days before scheduled colonoscopy. They were instructed to have a regular lunch and take only clear liquid or low-residual food for the dinner on the day before colonoscopy. The participants began to drink the first 2 L of PEG at 7:00-9 PM on the day before colonoscopy at a rate of 250 mL every 15 minutes. On the day of the procedure, patients took the remaining 2 L 4-6 hours before colonoscopy.
15944618|NCT03306030|Drug|Three times dose of 4L PEG|The same as mentioned above. The participants began to drink the first 1.5 L of PEG at 2:00 PM and the second 1.5L of PEG at 8:00PM on the day before colonoscopy at a rate of 250 mL every 15 minutes. On the day of the procedure, patients take the remaining 1.0 L 4-6 hours before colonoscopy.
15944619|NCT03306017|Other|Blood sampling|Three venous blood sampling before the left ventricular assist device implantation and 1 and 2 months after implantation in ambulatory patients.
15944620|NCT03306004|Other|Questionare|
15944621|NCT03305978|Device|Ultra low dose chest CT|An additional ultra low dose CT row is performed for every subject besides standard diagnostic low dose chest CT.
15944622|NCT03305978|Device|Low dose chest CT|standard diagnostic low dose chest CT
15944623|NCT03305965|Behavioral|Patient navigation|Consultations with a specifically trained oncology nurse (i.e. patient navigator), who assesses patients' needs for supportive cancer care, provides information on supportive cancer care, and guides patients through the supportive cancer care system. Consultations with the patient navigator take place at the start, halfway through, and at the end of treatment.
15944624|NCT03305952|Behavioral|CBCT|
15944625|NCT03305952|Other|TAU|
15944626|NCT03305939|Behavioral|Life style Intervention|"The intervention will include 4 face-to-face group sessions in the first 6 months, followed by remote support strategies and intensification counseling sessions when needed. Ongoing support and contact shown to be important in supporting behavior change will consist of reminders, and motivational messages for small actionable behaviors, delivered using mobile text or voice messages. Program intensification will be offered to women who fail to meet their weight goals by the 6 month time point. All phases of the program focus on self- management across 3 themes
~simple healthy eating and moderate physical activity messages;
~behavioral skills such as problem solving/goal setting/self-monitoring; and
~enhancing internal motivation, self-efficacy and self-management. The program is deliberately not prescriptive, and has a focus on sustainable behaviors and local context."
15944627|NCT03305926|Other|Conventional CVR programme|Programme in a CVR centre involving 20 sessions of reconditioning to effort, 3 times per week for roughly 7 weeks, as well as 14 sessions of therapeutic education in groups.
15944628|NCT03305926|Other|Connected CVR programme|First week in the CVR centre with 3 sessions combining reconditioning to effort, individual interviews and targeted therapeutic education, so as to define the objectives and methods of the connected CVR at home for the 6 following weeks.
15944629|NCT03305926|Other|Follow-up visit M2|Effort test and evaluation at the end of the CVR programme
15944630|NCT03305926|Other|Follow-up vsit M8|Evaluation at 8 months following the CVR programme
15944631|NCT03305913|Drug|TAS 102|TAS-102 tablet
15944632|NCT03305913|Drug|Regorafenib|Regorafenib tablet
15944633|NCT03305900|Other|No Intervention|Cross-sectional study requiring a single serum sample
15944634|NCT03305887|Device|"STRATAFIX™ Symmetric Knotless Tissue"|This devices will be used in deep and intermediate layers of barbed suture group.
15944635|NCT03305887|Device|VICRYL® PLUS|This devices will be used in deep and intermediate layers of conventional suture group.
15944636|NCT03305887|Device|"STRATAFIX Spiral sutures"|This devices will be used in intradermal layer of both barbed suture and conventional suture group.
15944637|NCT03305887|Device|DERMABOND™ Advance™ Skin Closure System|This devices will be used in skin layer of both barbed suture and conventional suture group.
15944745|NCT03304990|Other|Patients with CA or suspected risk of CA or a family Hx|Patients with Family History of Cancer, (ii) Patients with Clinical and Environmental Risk Factors for Cancer, (iii) Patients with a Suspected or Confirmed Diagnosis of Cancer.
15944638|NCT03305874|Other|Exposure to CBCIN risk score|The computer-based contrast induced nephropathy (CBCIN) risk score and associated standard hydration strategy will be displayed on a monitor in front of the treating interventional cardiologist during the entirety of the PCI case. Since this scoring system and hydration strategy are both available in the peer-reviewed literature, clinical use of these data and implementation of a CIN-avoidance strategy is not experimental; however, the display of these data to interventional cardiologists is experimental. Based on exposure to these data, the treating interventional cardiologist may use the information as clinically appropriate (i.e. it is not the basis for clinical decisions).
15944639|NCT03305861|Procedure|ThuLEP|Thulium laser enucleation of prostate
15944640|NCT03305861|Procedure|Green LEP|Greenlight laser enucleation of prostate
15944641|NCT03305848|Drug|Nitrostat 0.4Mg Sublingual Tablet|Up to 3 administrations of 0.4mg sublingual nitroglycerin tablets, dissolved in 10mL tap water, given orally in a single swallow. Each administration is separated by at least 5 minutes, and only if systolic blood pressure > 100 mmHg.
15944642|NCT03305822|Drug|LY900014|Administered SC
15944643|NCT03305822|Drug|Insulin Lispro|Administered SC
15944644|NCT03305809|Drug|LY3154207|Administered orally.
15944645|NCT03305809|Drug|Placebo|Administered orally.
15944646|NCT03305796|Radiation|Diffusion magnetic resonance imaging|Patients with suspected cholesteatoma will have diffusion magnetic resonance imaging
15944647|NCT03305783|Procedure|cholecystectomy|elective cholecystectomy performed due to gallstones, cholecystitis or other non-malignant conditions and therefore done regardless of the protocol of this study.
15944648|NCT03305770|Device|verofilcon A contact lenses|Daily disposable soft contact lenses
15944649|NCT03305770|Device|delefilcon A contact lenses|Daily disposable soft contact lenses
15944650|NCT03305757|Drug|Artiss|Application of ARTISS Glue to skin flaps after mastectomy
15944651|NCT03305757|Procedure|vicryl sutures|Flap fixation with vicryl sutures after mastectomy
15944652|NCT03305757|Procedure|Conventional|Conventional closure after mastectomy
15944653|NCT03305731|Behavioral|Activating Behavior for Lasting Engagement|Activating Behavior for Lasting Engagement (ABLE) is a behavioral intervention in which participants learn skills to schedule, self-monitor, and problem solve strategies to overcome barriers to engagement in meaningful daily life activities.
15944654|NCT03305718|Other|Meal sequence: 3C1A2B4D|Participants receive test meals in the sequence 3C1A2B4D
15944655|NCT03305718|Other|Meal sequence: 2A3D4C1B|Participants receive test meals in the sequence 2A3D4C1B
15944656|NCT03305718|Other|Meal sequence: 2D4B3A1C|Participants receive test meals in the sequence 2D4B3A1C
15944657|NCT03305718|Other|Meal sequence: 3B2C1D4A|Participants receive test meals in the sequence 3B2C1D4A
15944658|NCT03305718|Other|Meal sequence: 4C2B1A3D|Participants receive test meals in the sequence 4C2B1A3D
15944659|NCT03305718|Other|Meal sequence:1B4D3C2A|Participants receive test meals in the sequence 1B4D3C2A
15944660|NCT03305718|Other|Meal sequence:4A1C2D3B|Participants receive test meals in the sequence 4A1C2D3B
15944661|NCT03305718|Other|Meal sequence:1D3A4B2C|Participants receive test meals in the sequence 1D3A4B2C
15944662|NCT03305718|Other|Meal sequence: 4D3B2C1A|Participants receive test meals in the sequence 4D3B2C1A
15944663|NCT03305718|Other|Meal sequence: 3A4C1B2D|Participants receive test meals in the sequence 3A4C1B2D
15944664|NCT03305718|Other|Meal sequence: 1C2A3D4B|Participants receive test meals in the sequence 1C2A3D4B
15944665|NCT03305718|Other|Meal sequence: 2B1D4A3C|Participants receive test meals in the sequence 2B1D4A3C
15944666|NCT03305705|Drug|Iron Carboxymaltose|Single intravenous infusion within 20 min
15944667|NCT03305705|Drug|Sodium chloride 0.9%|Single intravenous infusion of 250 ml within 20 min
15944668|NCT03305692|Diagnostic Test|Optimization of CRT Device|Use a body surface mapping system to quantify electrical dyssynchrony or echocardiography to quantify diastolic blood flow characteristics. Program the pacemaker to maximize the benefit of the modality the subject is randomized to.
15944669|NCT03305679|Procedure|Direct provisional technique|The method of implantation will be accomplished directly.
15944670|NCT03305679|Procedure|Indirect Provisional technique|The method of implantation will be accomplished indirectly.
15944671|NCT03305666|Drug|Liposomal bupivacaine injection|A single injection of liposomal bupivacaine is administered at the time of SSRF, directly to the fracture site via VATS
15944672|NCT03305666|Drug|Bupivacaine indwelling catheter|Bupivacaine indwelling OnQ pain pump catheter is placed in the subscapular space at the time of SSRF for continuous bupivacaine infusion post op
15944673|NCT03305653|Device|Esophageal String Test (EST)|The EST is a gelatin capsule filled with a 90cm nylon string. A trailing end of the string protrudes from one end of the capsule. This end is taped to the cheek and the capsule is swallowed. As the capsule travels to the small intestine, the string inside the capsule is dislodged, leaving a string that goes from the cheek to the small intestine. The capsule dislodges from the string and the string is left in place, in the mouth, esophagus, stomach and small intestine for an hour. During this time, the string rubs against the inside of the esophagus and collects eosinophil proteins. After one hour, the string is removed through the mouth and placed in preservative to save the eosinophil proteins.
15944674|NCT03305640|Procedure|acetabular fracture surgery|acetabular fracture surgery
15944675|NCT03305627|Other|Short PAP|Perioperative antibiotic prophylaxis for 24h
15944676|NCT03305627|Other|Extended PAP|Perioperative antibiotic prophylaxis for >48h
15944677|NCT03305614|Device|tDCS|C-tDCS during the first 20 minutes of aphasia therapy, at an intensity of 1mA or sham-tDCS at an intensity of 0mA
15944678|NCT03305614|Behavioral|Aphasia therapy|Based on linguistic tests, individualized aphasia therapy will be provided
15944679|NCT03305601|Other|application on smarthphone|application on smarthphone
15944710|NCT03305328|Device|Transcranial Alternating Current Stimulation|Transcranial Alternating Current Stimulation passes a weak, 2 mA sinusoidal current through the scalp to the cortex at a specified frequency. Previous evidence suggests this exogenous sinusoidal stimulation interacts with the endogenous, cortical sinusoidal oscillatory activity, resulting in modulations of cortical oscillations. The intervention is non-invasive and virtually painless with no lasting adverse side-effects.
15944746|NCT03304977|Other|questionnaire via smartphone|questionnaire via smartphone
15945718|NCT03297489|Other|Laboratory Biomarker Analysis|Correlative studies
15944680|NCT03305588|Device|Unframed Virtual Cone|The patient will undergo stereotactic radiosurgery. Radiosurgery is a single non-surgical radiation treatment and will be done as an outpatient procedure. High-energy radiation will be delivered to a small, precise area of the patient's brain using a linear accelerator. A face mask (unframed) will be placed over the patient's face to keep their head from moving during the procedure. During the procedure, the study doctor will confirm the exact location that needs to be treated using x-rays and optical imaging cameras. The face mask will hold the patient's head to prevent it from moving and to focus the x-rays and aim them on a small area in the thalamus of the patient's brain. For most patients, the actual time on the radiosurgery treatment machine is 30 to 60 minutes. The face mask will be removed after the treatment.
15944681|NCT03305575|Drug|Chloroprocaine|"The patient will be randomly selected to receive either Chloroprocaine or Bupivacaine as the local medication for in spinal anesthesia, with a 50% chance to receive either drug.
~During the cervical cerclage procedure and in the recovery room, the patient will be checked for motor block (the ability to move feet and legs) and for sensory block(the ability to feel) using a plastic tip, every 5 minutes in the first hour, and at 10 minutes intervals afterwards until the anesthesia wears off completely. The patient will also be asked to walk and urinate after the local anesthetic wears off to ensure complete resolution of local anesthesia."
15944682|NCT03305575|Drug|Bupivacaine|"The patient will be randomly selected to receive either Chloroprocaine or Bupivacaine as the local medication for in spinal anesthesia, with a 50% chance to receive either drug.
~During the cervical cerclage procedure and in the recovery room, the patient will be checked for motor block (the ability to move feet and legs) and for sensory block(the ability to feel) using a plastic tip, every 5 minutes in the first hour, and at 10 minutes intervals afterwards until the anesthesia wears off completely. The patient will also be asked to walk and urinate after the local anesthetic wears off to ensure complete resolution of local anesthesia."
15944683|NCT03305549|Other|Conservative dialysis strategy|"Participants will receive RRT only when meeting 1 of the following indications (patterned after the AKIKI trial's delayed RRT initiation arm):
~Blood urea nitrogen >112 mg/dL (40 mmol/L)
~Serum potassium concentration >6 mmol/L
~Serum potassium concentration >5.5 mmol/L despite medical treatment (e.g., bicarbonate, glucose-insulin infusion, albuterol, diuretics, sodium polystyrene sulfonate)
~Arterial blood gas pH <7.15 in a context of pure metabolic acidosis (PaCO2 <35 mmHg) or in a context of mixed acidosis with PaCO2 50 mmHg despite medical treatment to reverse respiratory acidosis (e.g., naloxone), or in the absence of an available arterial blood gas, serum bicarbonate <12 mmol/L
~Acute pulmonary edema due to fluid overload, responsible for hypoxemia requiring oxygen flow rate >5 L/min to maintain SpO2 >95% or requiring FiO2 >50% in patients already on invasive or non-invasive mechanical ventilation and despite diuretic therapy"
15944684|NCT03305549|Other|TIW dialysis strategy|Thrice-weekly acute intermittent hemodialysis schedule.
15944685|NCT03305536|Dietary Supplement|Vitamin K2 (Menaquinone 7) + Vitamin D3|Vitamin K2 + Vitamin D3 arm will be compared with Vitamin D3 arm to slow of reverse the progression of the disease
15944686|NCT03305523|Device|Thermocautery|In the thermocautery method, a digital thermocautery device (Thermo-Med TM 802-B, Thermo Medical, Adana, Turkey) with 6 different temperature settings was used. Circumcision was performed in the same way as the surgical circumcision. Only cutting and bleeding intervention was done by using a thermocautery device. Cutting was performed by making the appropriate heat adjustment according to the age of the child and the thickness of the glans. Hemorrhage control was performed with a thermocautery device and then the skin-mucosa integrity was ensured by using a 5/0 absorbable suture
15944687|NCT03305510|Diagnostic Test|vitamin D is below 20ng/ml|
15944688|NCT03305497|Behavioral|Mobile Phone Application|110 persons will be equipped with a mobile phone application, trained in overdose prevention, and equipped with naloxone. The mobile phone app will allow persons witnessing an overdose to signal persons in the vicinity to respond with naloxone.
15944689|NCT03305484|Other|No intervention|No intervention, observation only
15944690|NCT03305471|Drug|DS-2330b PIB|DS-2330b as powder in bottle with stock solution (PIB)
15944691|NCT03305471|Drug|Placebo|Placebo matching stock solution in bottle
15944692|NCT03305471|Drug|Sevelamer|Sevelamer is a phosphate binder. It is used to decrease serum phosphate (Pi) level in people with chronic kidney disease who are on dialysis.
15944693|NCT03305471|Drug|DS-2330b Tablet|DS-2330b as tablet formulation
15944694|NCT03305458|Behavioral|TFCBT|treatment as usual
15944695|NCT03305458|Behavioral|eTFCBT|tablet-facilitated Trauma Focused Cognitive Behavioral Therapy (eTFCBT)
15944696|NCT03305445|Drug|Ipilimumab|Ipilimumab (1mg/kg)
15944697|NCT03305445|Drug|Nivolumab|Nivolumab (3mg/kg)
15944698|NCT03305432|Combination Product|sleeve + preoperative PPI|sleeve + preoperative PPI
15944699|NCT03305432|Combination Product|sleeve + preoperative Placebo|sleeve + preoperative Placebo
15944700|NCT03305419|Drug|GSK2982772 capsule|GSK2982772 will be available as size 00, white, opaque capsule containing white to almost white Solid (120 mg maximum fill per capsule). It will be administered orally with water to receive total dose of 120 mg, 240 mg or 360 mg per randomization.
15944701|NCT03305419|Drug|Placebo capsule|Placebo will be available as size 00, white, opaque capsule containing white to almost white Solid. It will be administered orally with water.
15944702|NCT03305406|Other|Focus groups|Focus groups will be conducted to gather information on clients view of a community support program focusing on healthy infant nutrition
15944703|NCT03305406|Other|Interviews|Interviews will be conducted to gather information on clients view of a community support program focusing on healthy infant nutrition
15944704|NCT03305393|Device|Adaptiv CRT|Adaptiv CRT algorithm to be programmed to ON in CRT devices of study patients at 6 month follow-up visit
15944705|NCT03305380|Other|No interventions|As this is a patient registry, there are no interventions.
15944706|NCT03305367|Dietary Supplement|Hydrolyzed pine nut oil|Randomized cros-over intervention of 3 OGTT with no oil, low dose or high dose.
15944707|NCT03305354|Behavioral|CBTI app intervention|Self-management guided use of a mobile app called the CBT-I Coach to teach sleep hygiene and enhance sleep
15944708|NCT03305354|Behavioral|Physical Activity intervention|Self-management guided motivation to increase physical activity by increasing daily step counts
15944709|NCT03305341|Biological|COVID-19 Therapeutic Biologics - Spike-GM-CSF Protein Lactated Ringer's Injection|"Intradermic Injection, ID
~COVID-19 Spike-GM-CSF Protein Lactated Ringer's Injection"
15944711|NCT03305315|Other|Measurements of jaw movement|Jaw mobility will be measured during simple movements of the mouth (opening the mouth, side-to-side and backwards-and-forwards movement of the jaw). These movements will be measured using a specific apparatus, part of which will be placed on the head like a helmet with the other part placed in the mouth and stuck to the teeth using a dental adhesive. The part in the mouth is specifically designed for this purpose. Measurements using this apparatus will take around 30 minutes.
15944712|NCT03305315|Other|Measurement of natural electrical activity of facial muscles|Natural electrical activity of the facial muscles will be measured using electrodes placed on the skin.
15944713|NCT03305302|Procedure|Sample of cancerous epithelium from the tongue|Harvesting and culture of cancerous epithelium from the surgical piece
15944714|NCT03305289|Procedure|pulsed Radiofrequency|sensory stimulation will be carried out at 50 Hz. The definitive position of the electrode will be verified by inducing paresthesia with sensory stimulation between 0.1-0.3 V in the affected painful area, then pulsed radiofrequency will be applied for 10 patients for 10 mins
15944715|NCT03305289|Procedure|thermal Radiofrequency|sensory stimulation will be carried out at 50 Hz. The definitive position of the electrode will be verified by inducing paresthesia with sensory stimulation between 0.1-0.3 V in the affected painful area, then Thermal lesion will be applied for 10 patients for 2 cycles of 90 seconds
15944716|NCT03305263|Drug|Hydroxychloroquine|One tablet a day from inclusion until end of pregnancy or gestational age 28
15944717|NCT03305263|Drug|Hydroxychloroquine placebo|One tablet a day from inclusion until end of pregnancy or gestational age 28
15944718|NCT03305250|Device|Implantable Loop Recorder|An implantable loop recorder (ILR), also known as an insertable cardiac monitor, is a small device (smaller than a AAA battery) that is inserted under the skin on the front of the chest. The ILR is inserted using local anesthetic as an out-patient procedure and lasts approximately 30 minutes. The ILR captures a continuous ECG of your heart activity, which allows doctors to detect any abnormal heart rhythms at any point. If you have the ILR, you will have the device for 3 years, after which it will be removed under local anesthetic during an out-patient procedure, again lasting approximately 30 minutes. The ILR device is completely safe and shouldn't affect your day to day living.
15944719|NCT03305237|Other|Big Breakfast|Weight loss diet (Calories fed to measured RMR) with calories distributed predominantly at breakfast (percent daily calories split between breakfast, lunch and dinner as 45-35-20%). The diet will be high protein (30% protein, 35% fat and 35% CHO) with all meals provided.
15944720|NCT03305237|Other|Big Dinner|Weight loss diet (Calories fed to measured RMR) with calories distributed predominantly at dinner (percent daily calories split between breakfast, lunch and dinner as 20-35-45%). The diet will be high protein (30% protein, 35% fat and 35% CHO) with all meals provided.
15944721|NCT03305224|Drug|Ra-223 in combination with enzalutamide|Ra-223 (55 kBq/kg i.v.) 6 injections at 4 weeks interval in combination with enzalutamide 160 mg per a day
15944722|NCT03305211|Other|sample|Participation in NephroMIC involves additional blood samples of 5 tubes (35 mL) and an additional sample of fresh urine.
15944723|NCT03305198|Biological|Capillary blood sampling from the earlobe|Sample at rest before the walking test Sample at rest 3 minutes after the end of the walking period
15944724|NCT03305185|Combination Product|Schroth SSE with Bracing|Patients in this group will be prescribed an outpatient-based Schroth exercise program, as per our preliminary study. It consists of an individualised eight-week outpatient program that includes four initial private training sessions, once every two weeks, where exercises will be taught to the patient and their caregivers. A home exercise program will be instituted thereafter and patients will be required to return for supervised sessions once every two months.
15944725|NCT03305185|Device|Bracing alone|Patients in the control group will receive standard level of care for bracing, which consists of education on general exercises for spinal movement, strengthening, and balancing. These patients will only attend study assessments with no extra physiotherapy sessions.
15944726|NCT03305172|Behavioral|Financial Incentive|Giving different structures of long term (36 weeks) financial incentives to increase physical activity
15944727|NCT03305159|Drug|Povidone-Iodine|Patients will receive povidone iodine for the surgical preparation of the vagina.
15944728|NCT03305159|Drug|4% Chlorhexidine Gluconate|Patients will receive 4% chlorhexidine gluconate for the surgical preparation of the vagina.
15944729|NCT03305146|Genetic|Molecular biology analysis of pancreatic intra-cyst fluid|"The EUS FNA will be performed according to the Francophone Club of Echo Endoscopy recommendations.
~For molecular biology technique, the samples will be processed within the UMR_S910 unit. Nucleic acids will be extracted from the intra-cystic fluid or, for post-operative patients, from a resected specimen that will be collected into a tube containing a nucleic acid stabilization solution (Allprotect Tissue reagent, Qiagen).
~The nucleic acids will be extracted and then sequenced. The sequencing technology chosen (HaloPlexHS, Agilent) allows a detection close to 1% in allelic frequency. This new technical approach that links high sensitivity and specificity is also suitable with degraded and/or low-volume ( <50ng) DNA."
15944730|NCT03305133|Other|Immunohistochemistry|The slides which allowed the large cell neuroendocrine carcinoma diagnosis will be re-read centrally.
15944731|NCT03305120|Other|pain VAS evaluation|each patient has to answer to a questionnaire about pain
15944732|NCT03305107|Other|Exercise and Chocolate Milk|High intensity interval exercise Chocolate Milk
15944733|NCT03305107|Other|Exercise and Water|High intensity interval exercise Water
15944734|NCT03305107|Other|Sitting and Chocolate Milk|Sitting Chocolate Milk
15944735|NCT03305107|Other|Sitting and Water|Sitting Water
15944736|NCT03305094|Procedure|Blood pressure cuff inflation|Cuff pressure for ischemia sham is 20 mm Hg, ischemia is 200 mm Hg and reperfusion is 0 mm Hg
15944737|NCT03305081|Device|Levonorgestrel IUD, copper IUD, etonorgestrel implant|Long-acting reversible contraception
15944738|NCT03305068|Drug|Celecoxib|
15944739|NCT03305055|Drug|ketamine|Information included in arm descriptions
15944740|NCT03305055|Drug|Fentanyl|Information included in arm descriptions
15944741|NCT03305029|Drug|SCNT-hES-RPE Cells|Pars Plana Vitrectomy and Sub-retinal Transplantation of Human Somatic cell nuclear transfer Embryonic Stem Cell Derived Retinal Pigmented Epithelial(SCNT-hES-RPE) Cells in Patients with Advanced Dry Age-related Macular Degeneration
15944742|NCT03305016|Drug|TransCon hGH|Once weekly subcutaneous injection at a starting dose of 0.24 mg/kg/week
15944743|NCT03305003|Other|Spiral notebook|
15944747|NCT03304964|Drug|FP-025 (MMP-12 inhibitor)|Treatment A: 14 oral doses of 100 mg FP-025 (n=6) or placebo (n=2) in 8 days.
15944748|NCT03304964|Drug|FP-025 (MMP-12 inhibitor)|Treatment B: 14 oral doses of 200 mg FP-025 (n=6) or placebo (n=2) in 8 days.
15944749|NCT03304964|Drug|FP-025 (MMP-12 inhibitor)|Treatment C: 14 oral doses of 400 mg FP-025 (n=6) or placebo (n=2) in 8 days.
15944750|NCT03304964|Drug|FP-025 (MMP-12 inhibitor)|Treatment D: single oral dose of 200 mg FP-025 under fasted conditions.
15944751|NCT03304964|Drug|FP-025 (MMP-12 inhibitor)|Treatment E: single oral dose of 200 mg FP-025 after intake of a high-fat, high-calorie breakfast (fed condition).
15944752|NCT03304951|Device|Sinopsys® Lacrimal Stent|The Sinopsys® Lacrimal Stent is indicated for use in creating a transcaruncular ethmoid access.
15944753|NCT03304938|Drug|Lavender Oil|The intervention group pour 3 drops of Lavender essential oil on a cotton wool then smell it rhythmic and slowly for 5 minutes at bed time for 4 weeks
15944754|NCT03304938|Drug|Placebos|The placebo group pour 3 drops of Almond oil on a cotton wool then smell it rhythmic and slowly for 5 minutes at bed time for 4 weeks
15944755|NCT03304925|Device|The ZELTIQ System|The CoolSculpting machine will be used to perform the treatments.
15944756|NCT03304912|Behavioral|PrEP Education and option to accept a PrEP prescription|Participants will receive educational information about PrEP, be offered a PrEP prescription, and those who choose to initiated PrEP will be monitored for side-effects and adherence at their follow-up visit. There is no group assignment within this study and WWID do not have to choose to initiate PrEP. Rather, the goal of this study is to understand factors that impact PrEP initiation (and engagement in the PrEP care continuum).
15944757|NCT03304899|Drug|RiaSTAP Injectable Product|"RiaSTAP, Fibrinogen Concentrate (Human) is a human blood coagulation factor indicated for the treatment of acute bleeding episodes.
~Dose (mg/kg body weight) =
~([Target level (mg/dL) - measured level (mg/dL)])/(1.7 (mg/dL per mg/kg body weight))"
15944758|NCT03304873|Drug|Retapamulin|Retapamulin is a topical antibiotic ointment. The ingredients include retapamulin and white petrolatum as the vehicle. The composition is 10mg retapamulin per 1g of ointment (1%).
15944759|NCT03304873|Drug|Placebo Ointment|The placebo that will be used is triple-purified pharmaceutical-grade petrolatum.
15944760|NCT03304860|Other|Survey|Survey with 4-7 questions about each parents' demographics and CRC screening history. Depending on answers, provided a CRC screening document and asked to discuss screening with parents, followed by a brief survey in 4 months
15944761|NCT03304847|Other|ablation|radio-frequency applications on arrhythmogenic substrate
15944762|NCT03304834|Device|ECHOPULSE|Patient are treated with the HIFU device and the physician is doing a compressive bandage.
15944765|NCT03304808|Device|Exercise Programme +device+ lubricant|"A first line treatment for the PE of a new 7 weeks exercise programme to control male orgasm using a masturbation aid device in a variation of the classical stop-start technique first introduced by Semans in 1956.
~Four exercise:
~Exercise of Masturbation that intends to raise awareness of the ejaculatory response and identify the tension on the muscles of the genital area .
~Star and Stop to identify the tension and try to reduce this tension, on the pelvic floor muscles pay special attention to the anal sphincter.
~Delay the ejaculatory response on four different occasions, by loosening the tension in the genital area and relaxing the anal sphincter not stop masturbating
~Practice the ability to delay ejaculation as in previous exercises, but this time performing hip movements similar to penetration not stop masturbating"
15944766|NCT03304808|Behavioral|Exercise Programme + lubricant|"A first line treatment for the PE of a new 7 weeks exercise programme to control male orgasm using a masturbation aid device in a variation of the classical stop-start technique first introduced by Semans in 1956.
~Four exercise:
~Exercise of Masturbation that intends to raise awareness of the ejaculatory response and identify the tension on the muscles of the genital area .
~Star and Stop to identify the tension and try to reduce this tension, on the pelvic floor muscles pay special attention to the anal sphincter.
~Delay the ejaculatory response on four different occasions, by loosening the tension in the genital area and relaxing the anal sphincter not stop masturbating
~Practice the ability to delay ejaculation as in previous exercises, but this time performing hip movements similar to penetration not stop masturbating"
15944767|NCT03304782|Other|Fitbit activity tracker|Wearable device that records the number of steps a person takes throughout the day
15944768|NCT03304769|Device|Virtual Reality|Virtual Reality Headset applied to the patient during placement of IV. Control is patient group without headset applied.
15944769|NCT03304756|Drug|CAP|cisplatin (50 mg/m2) in combination with doxorubicin (50 mg/m2) and cyclophosphamide (500 mg/m2) every 21 days and for a total of 6 cycles
15944770|NCT03304743|Diagnostic Test|Dental panoramic radiograph|"If not performed within the previous 12 months at the Centre of Dentistry, an OPG will be performed during enrolment visit.
~OPGs are routine low-dose x-rays that are often performed during dental check-ups, follow-ups or before dental treatments (e.g. extractions, implant placement, etc.), as they allow the evaluation of both bone and dental structures of both jaws, the sinus and temporo-mandibular joints."
15944771|NCT03304717|Drug|Tenofovir (TDF) and Emtricitabine (FTC)|"Tenofovir (TDF): a nucleotide reverse transcriptase inhibitor (NtRTI) an acyclic nucleotide analog of adenosine 5'-monophosphate. This is used in children as young as age 2.
~Emtricitabine (FTC): a nucleoside reverse transcriptase inhibitor (NRTI), a synthetic analog of cytidine which binds at the active site of the reverse transcriptase."
15944772|NCT03304717|Other|Placebo|Placebo for Tenofovir and Placebo for Emtricitabine
15944773|NCT03304652|Drug|Zaleplon|Sleep Aid; 10mg; Oral; Single Use
15944774|NCT03304652|Other|Natural Sleep|Natural Sleep without medication
15944775|NCT03304639|Biological|Pembrolizumab|Given IV
15944776|NCT03304639|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15944777|NCT03304626|Drug|Budesonide 3Mg Capsule|Budesonide capsule in place of prednisone (standard of care)
15944778|NCT03304626|Drug|Standard of Care Prednisone|Prednisone taper (Standard of Care)
15944779|NCT03304613|Behavioral|Web-based Cognitive Behavioral Therapy (e-CBT) Self-Management|Already noted.
15944780|NCT03304613|Behavioral|Promoting Resilience through Innovative Self-Management|Already noted.
15944781|NCT03304600|Device|Active stimulation|Patients will receive a tDCS stimulation during 30 mn with an intensity of 2 milliampere (mA).
15944782|NCT03304600|Device|Sham stimulation|Patients will receive a Sham stimulation during 30 mn
15944783|NCT03304587|Diagnostic Test|Polysomnography (PSG)|Sleep patterns will be measured by in-lab PSG following a standardized protocol. 10mm silver/silver chloride electroencephalogram (EEG) and electromyography (EMG) electrodes and 11mm silver/silver chloride electroculography (EOG) electrodes will be connected to a Nihon Kohden system, 912 model (Nihon Kohden, Irvine, CA). A standard sleep montage following the 10/20 procedure for electrode placement, left and right electrooculography referenced to the opposite mastoid and mentalis electromyography will be followed. Data will be visually scored by a polysomnographer blind to study conditions following the American Academy of Sleep Medicine (AASM) Manual.
15944784|NCT03304587|Diagnostic Test|Rectal thermistor 400 Series|Nocturnal core body temperature will be measured using a rectal thermistor 400 series manufactured by YSI (Yellow Springs, OH, USA) inserted up to a depth of 7 cm. and taped in place. The thermistor will be connected to a Model 4600 thermometer (YSI, Yellow Springs, OH, USA) that will be interfaced with the PSG via cabling. Core temperature readings will be continuously monitored and recorded every 5 minutes during the all-night sleep studies.
15944785|NCT03304587|Other|Bright blue-green light|-The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
15944786|NCT03304587|Other|Dim red light|-The cap visor-mounted device controls the distance of the light exposure, and positions the light source above eye level to target on the lower retina for better effect
15944787|NCT03304587|Diagnostic Test|Digital foot candle datalogging light meter|"On 2 random days during the 2-week bright light treatment, ambient light will be recorded continuously during waking hours using a digital foot candle datalogging light meter (Extech Instruments, Waltham, MA) Model SDL400. The 7.1 x 2.9 x 1.0 light meter (12.21 oz) has the capacity to measure up to 10,000 footcandles (accuracy: ± 4% reading). The light-weight light sensor is approximately 2 inches in diameter and comes with a clip and strap that makes it comfortable to wear just below the neck."
15944788|NCT03304587|Other|Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue|8 items with a 5-point rating scale (1=not at all to 5 =very much) measuring fatigue experience and fatigue impact. Higher scores indicate worse fatigue. PROMIS-Fatigue was developed based on rigorous methodologies. The psychometric properties have been established across chronic illnesses including cancer.
15944789|NCT03304587|Other|Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance|8 items with 5-point rating scales measuring overall sleep and sleep-related impairments. Higher scores indicate worse sleep disturbances. Validity was supported by moderate to high correlations with the existing scales, e.g. PSQI, Epworth Sleepiness Scale (ESS). The scores significantly differed participants with and without sleep disorders.
15944790|NCT03304587|Other|Patient-Reported Outcomes Measurement Information System (PROMIS)-Depression|8 items with 5-point rating scales (1=never to 5=always) measuring affective and cognitive manifestations of depressive mood. Higher scores indicate worse depression. In a sample of depressed outpatients, PROMIS-Depression showed greater reliability when compared to the CES-D and the Patient Health Questionnaire (PHQ-9). Convergent validity with the CES-D and PHQ-9 was supported by strong correlations, ranged 0.72 to 0.84
15944791|NCT03304587|Other|Patient-Reported Outcomes Measurement Information System (PROMIS)-Physical Function|8 items with 5-point rating scales measuring the individual's ability to complete daily activities. Higher scores indicate worse functioning. Validity was tested in 1,415 adults with diverse clinical conditions. The PROMIS Physical Function scores corresponded to the expected positive or negative changes in the individual's physical function.
15944792|NCT03304587|Other|Pittsburgh Sleep Quality Index (PSQI)|19 self-report items measuring sleep quality, latency, duration, efficiency, disturbance, medication use, and daytime dysfunction. Each item is rated on a 0-3 rating scale. The global PSQI score ranges 0-21, with higher scores indicating more severe sleep disturbance. A global PSQI score greater than 5 was found to have a sensitivity of 89.6% and a specificity of 86.5% in differentiating good and poor sleepers.
15944793|NCT03304587|Other|Center for Epidemiological Studies - Depression|20-item self-report instrument commonly used to measure depressive symptoms in cancer patients. Each item is rated on a 4-point rating scale (0=rarely or none of the time to 3=all of the time) describing the frequency of occurrence during the past week. Score can range from 0-60, with higher scores indicating more depressive symptoms.
15944794|NCT03304587|Other|Montreal Cognitive Assessment (MoCA)|The MoCA is highly sensitive for screening patient with mild cognitive impairment. The MoCA is a 30-point scale with 7 cognitive subtests: visuo-executive, naming, attention, language, abstraction, delayed recall, and orientation. It scores from 0 to 30, where higher scores indicate better cognition and a score below 26 indicates cognitive impairment. The MoCA is highly sensitive for screening patient with mild cognitive impairment.
15944795|NCT03304587|Other|European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire (EORTC QLQ-C30)|The EORTC QLQ-C30 consists of 30 items with a 4-point rating scale (1=not at all to 4=very much) measuring functioning, symptom intensity, and global health status/quality of life during the past week.
15944796|NCT03304587|Other|Daily Log|-A log where the participants will indicate date, wake time, sleep time answer 3 questions regarding the previous nights sleep (answers range from 1=not at all to 5=very much), have an area to indicate if naps occurred during the day, and 2 questions about fatigue & sleepiness (answers ranging from 0=no fatigue/sleepiness to 10=worst fatigue/sleepiness
15944797|NCT03304574|Behavioral|Integrated personalized feedback|Integrated personalized feedback about self-reported risk behaviors will be generated and shown to participants as they complete their baseline health risk assessment using the CheckED Yourself app. The integrated personalized feedback is based on motivational feedback strategies such as normative feedback (comparison to peer behaviors and age-based health guidelines), increasing knowledge regarding potential consequences of behaviors, and providing practical tips for changing behavior.
15980807|NCT03030859|Other|Usual Care|Undergo usual care only
15944799|NCT03304561|Other|Cross-over training|Cross-over training addition to the traditional rehabilidation
15944800|NCT03304548|Other|Telephone concept elicitation interview|All interview questions are designed to be very open-ended in order to ascertain subjects' preferences in an un-biased manner (as possible), with additional probes only being used when necessary to ensure all concepts of interest are covered. Subjects will be asked a series of broad, open-ended questions designed to encourage them to talk openly and as spontaneously as possible about their experience of taking oral treatment(s) for their PAH.
15944801|NCT03304522|Drug|VX-150|1250 mg total dose administered as 250-mg capsules orally
15944802|NCT03304522|Drug|Placebo|Matching Placebo
15944803|NCT03304509|Other|Telematic follow-up|Telematic follow-up by using a platform with videoconference
15944804|NCT03304496|Drug|Nitroglycerin 100 MCG/ML Injectable Solution|Previously described.
15944805|NCT03304496|Drug|Saline Solution|Previously described.
15944806|NCT03304483|Other|246-km running|Spartathlon 2017
15944807|NCT03304470|Drug|ATx201 2% Cream|Anhydrous Cream
15944808|NCT03304470|Drug|ATx201 Cream Vehicle|Anhydrous Cream
15944809|NCT03304457|Drug|Olanzapine|Olanzapine 10mg once daily orally for 6 weeks
15944810|NCT03304457|Drug|Lurasidone|Lurasidone 80mg once daily orally for 6 weeks
15944811|NCT03304444|Drug|Bupivacaine|bupivacaine hydrochloride used in TAP block
15944812|NCT03304444|Drug|liposomal bupivacaine|liposomal bupivacaine used in TAP block
15944813|NCT03304431|Drug|Orotracheal Lidocaine Oral Spray application|The induction of group L will be performed 5 minutes after administration of 10% topical lidocaine (Lidocaine pump spray 10% 50 ml) 160 mg (16 puffs) application
15944814|NCT03304418|Drug|Radium Ra 223 Dichloride|Radium Ra 223 dichloride will be delivered intravenously at 55 kBq/kg (1.49 mCi)/kg (+/- 10% total dose) for a total of six cycles. 1 cycle= 28 days. The first cycle will commence at study enrollment, then cycles 2-6 will commence after the completion of radiotherapies at 4 week intervals
15944815|NCT03304418|Radiation|Radiation|"All external beam radiations oligometastatic sites will commence after cycle 1 of Radium-223 but prior to cycle 2 of Radium-223. All subjects will receive Stereotactic body or hypofractionated radiation to sites of bone disease seen on imaging studies. Patients will have the primary tumor sites and 5 or fewer sites of bone-only metastasis treated with external beam radiation.
~Any of the following regimens are considered ablative, acceptable and are biologically equivalent to 60Gy EQD2:
~Single fraction: 16 Gy total at 16 Gy per fraction (SBRT)
~Three fractions: 24 Gy total at 8 Gy per fraction (SBRT)
~Five fractions: 30 Gy total at 6Gy per fraction (SBRT).When using five fractions, can reduce to 25 Gy total at 5 Gy per fraction (SBRT) or to a minimum of 20 Gy total at 4 Gy per fraction (SBRT), per treating investigator.
~Six fractions: 32.4 Gy total at 5.4Gy per fraction (Hypofractionated)"
15944816|NCT03304405|Diagnostic Test|Gait Analysis|All patients will undergo gait analysis using reflective surface markers placed at different locations on the head, trunk, upper and lower extremities, and pelvis. All patients will complete an analog pain scale, Oswestry, and SRS-22 questionnaires. These are health-related quality of life questionnaires that provide subjective assessment.
15944817|NCT03304392|Behavioral|Personalized ICBT|An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants. All clients will receive support from registered social workers, psychologists or supervised graduate students, with experience delivering ICBT, with contact depending upon group allocation. In addition to the online program, therapists, registered social workers, psychologists or supervised graduate students, with experience delivering ICBT will provide support within one business day of client emails. Amount of contact will be personalized to patients' needs.
15944818|NCT03304392|Behavioral|Standard ICBT|An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants. All clients will receive support from registered social workers, psychologists or supervised graduate students, with experience delivering ICBT, with contact depending upon group allocation. In addition to the online program, therapists, registered social workers, psychologists or supervised graduate students, with experience delivering ICBT will provide support by email only once a week. Therapist will spend approximately 15 minutes per week/per client.
15944819|NCT03304379|Drug|Fasinumab|Solution for injection in pre-filled syringe
15944820|NCT03304379|Other|Diclofenac|NSAID active comparator (capsule)
15944821|NCT03304379|Other|Celecoxib|NSAID active comparator (capsule)
15944822|NCT03304379|Drug|Matching placebo|Fasinumab-matching placebo (solution for injection in pre-filled syringe); NSAID-matching placebo (capsule)
15944823|NCT03304366|Diagnostic Test|Pentacam (scheimpflug imaging)|Corneal changes including thickness, elevations....etc
15944824|NCT03304353|Other|Self-managed protocol|"Participants will be asked to complete a heel raise standing with the forefoot on a step. The toes are maximally dorsi flexed by placing a towel underneath them. The participant is instructed to perform a heel raise to maximal plantar flexion in the ankle joint and afterwards to lower the heel to maximal dorsiflexion. Supporting oneself for balance by placing the hands on a wall or a rail is allowed.
~The participants in the self-managed group are instructed in performing the exercise with a load as heavy as possible but no higher than 8RM and for as many sets as possible every other day."
15944825|NCT03304353|Other|Predetermined protocol|"Participants will be asked to complete a heel raise standing with the forefoot on a step. The toes are maximally dorsi flexed by placing a towel underneath them. The participant is instructed to perform a heel raise to maximal plantar flexion in the ankle joint and afterwards to lower the heel to maximal dorsiflexion. Supporting oneself for balance by placing the hands on a wall or a rail is allowed.
~The participants in the predetermined group are instructed in performing the exercise at a 12RM for three sets during week 1 and 2, at a 10RM for four sets during week 3 and 4, and at an 8RM for five sets from week 5 and onwards."
15944826|NCT03304340|Device|functional electrical stimulation (FES)|Two dual-channel stimulators (MEDTRONIC Respond Select；Empi Inc) were connected with a program timer to form one stimulating unit for functional electrical stimulation (FES). FES was delivered with 0.3-ms pulses at 30 Hz, maximum tolerance intensity about 20 to 30 mA to cause visible muscle contraction.
15944827|NCT03304340|Device|transcutaneous nerve stimulation (TENS)|Transcutaneous nerve stimulation (TENS) stimulator (BioTENS, Skylark Device & Systems Co., Ltd,) was applied with 0.2 ms pulses, at 100 Hz in the constant mode within the subject'sensory level without muscle contraction, via (5 × 3.5 cm) electrodes attached to the motor points of quadriceps and tibialis anterior (TA) on the affected lower extremity.
15944828|NCT03304340|Other|standard rehabilitation (SR)|The standard rehabilitation (SR) program was a part of a regular intervention in stroke center. The activities of SR performed including neurodevelopment facilitation techniques, range of motion exercises and movement re-learning exercises etc.
15944829|NCT03304327|Behavioral|Mindfulness and Yoga Training|"Centering and Breathing- Practice begins by turning attention to the breath to help participants make the transition from the busy, doing, outward focus of daily life into the mindful, balanced, internal focus central to yoga practice.
~Practices:Breath awareness, the relaxed abdominal breath. Posture Practice-Warm up with the range-of-motion sequence to take the major joints of the body through their full range of motion.This is done lying down with the head on the floor; the head can be supported by a small, folded towel if desired.
~Practices: Knee-to-chest sequence, Arms and Shoulders, Gentle Spinal Twist, Apanasana.
~Standing Poses for Strength and Balance, to enhance function and confidence. Practices: Mountain Pose, Flying Crane Sequence, Tree Pose, Warrior 2 and Side Angle.
~Relaxation- Practice concludes with guided relaxation to quiet the mind and calm the body.
~Practices: Seated Mountain Pose, even breath, extended exhalation,Yoga Nidra."
15944830|NCT03304314|Diagnostic Test|objective chromatic multifocal pupillometer|objective chromatic multifocal pupillometer (OCMP) enables objective and accurate measurement of pupillary responses to chromatic light at different wavelengths and light intensities and at different visual field locations.
15944831|NCT03304301|Behavioral|sunlight exposure|Participants will be encouraged to reduce time spent on bed and bedroom. We will also take participants outdoors and receiving sunlight exposure (if the UV index is over 8 according to the forecast of Center Weather Bureau, the participants will be asked to stay inside) five days a week for three months
15944832|NCT03304288|Drug|Rituximab|Low-dose rituximab was used in combination with ATRA or as the monotherapy
15944833|NCT03304288|Drug|All-trans retinoic acid|ATRA was used in combination with low-dose rituximab
15944834|NCT03304275|Behavioral|Tdap|Randomized controlled trial of 2 strategies to provide adults with the Tdap vaccine
15944835|NCT03304262|Device|rTMS|Between time point M2 and M3, participant will receive 900 pulses of rTMS at 1Hz at 0.85 of M2 resting motor threshold.
15944836|NCT03304249|Behavioral|iAmHealthy Healthy Lifestyles Program|iAmHealthy is behavioral intervention focused on nutrition, behavior and physical activity that engages parents and children in treatment using mobile health (mHealth) technology. Meetings are approximately one hour. Participants will log in for 8 weekly group sessions, followed by 6 monthly sessions.
15944837|NCT03304249|Other|Newsletter|Weight loss materials delivered via a newsletter. Each newsletter will cover nutritional, exercise, and behavioral suggestions to improve the child's health. The newsletter will be sent in the mail once a month for 8 months.
15944838|NCT03304236|Device|Myelopathy Hand|Patients will undergo radiological and clinical examination at the Duchess of Kent Children Hospital. Patients will be required to put on a pair of hand gloves with 18 IMUs located on specific bony landmarks (distal phalanges of fingers, proximal phalanges of index fingers and thumbs, dorsum of the hands and bilateral wrists)
15944839|NCT03304223|Diagnostic Test|[18F]FB-IL2 PET scan|[18F]FB-IL2 PET scan procedure
15944840|NCT03304210|Drug|PIPAC with Abraxane|Albumin bound nanoparticle paclitaxel (Abraxane) will be administered intraperitoneally using the PIPAC technique. The administered dose will escalate ranging from 35 to 140 mg/m². PIPAC will be performed every 4 weeks for 3 cycles.
15944841|NCT03304197|Dietary Supplement|Hypotonic|N/A: see arm description
15944842|NCT03304197|Dietary Supplement|Isotonic|N/A: see arm description
15944843|NCT03304197|Dietary Supplement|Placebo|N/A: see arm description
15944844|NCT03304197|Other|Dehydrated|N/A: see arm description
15944845|NCT03304184|Device|Photac-fil|Application of a tooth colored filling in a non-cavitated dental lesion.
15944846|NCT03304184|Device|Biodentine|Application of a white colored filling in a non-cavitated dental lesion.
15944847|NCT03304158|Behavioral|FCHV visit|FCHVs will visit selected households 3 times a year for providing health promotion messages and measure the blood glucose
15944848|NCT03304145|Other|The Carevive CPS|The Carevive Care Planning System (CPS) was developed to overcome challenges by providing an efficient, clinically integrated solution for both psychosocial and physical symptom distress screening and management through the delivery of personalized and evidence-based care plans at the point of care. The Carevive CPS simultaneously collects and aggregates discrete data for quality reporting and improvement.
15944849|NCT03304132|Other|Classification of Oral Microbiome Using 16S rRNA gene sequence-based approach|The sequence-based approach is selected because it classifies samples by considering the entire difference (genetic distance) in 16S rRNA gene sequences among samples analyzed, unbiased by artificial details such as taxonomies, sequence length, or even quality scores.
15944850|NCT03304132|Other|Classification of Oral Microbiome Using taxonomic approach|The taxonomic approach is a complement to the sequence-based approach in that it will further identify specific taxonomic groups or species that can explain the difference found by overall analyses.
15944851|NCT03304106|Device|Commercially available cochlear implant and AI system|Use of AI technology to assist in audiologist's evaluation and programming of cochlear implant recipients
15944852|NCT03304093|Drug|Nivolumab Injection|Nivolumab 3mg/kg every 2 weeks
15944853|NCT03304080|Drug|Anastrozole|1 mg orally daily, day 1 to day 28
15944854|NCT03304080|Drug|Palbociclib|Dose I: 100 mg orally daily, day 1 to day 21, then 7 days off in a 28 day cycle (Phase 1 only) Dose II: 125 mg orally daily, day 1 to day 21, then 7 days off in a 28 day cycle
15944855|NCT03304080|Drug|Trastuzumab|8 mg/kg IV initial loading dose, followed by 6 mg/kg IV every 21 days
15944856|NCT03304080|Drug|Pertuzumab|840 mg IV followed by a maintenance dose of 420 mg IV every 21 days
15944857|NCT03304067|Behavioral|Tueo Program|The asthma management solution utilizes devices (2 to attach on the child's bed and 1 for data transmission), which collect various metrics for a tailored smartphone application experience. The smartphone application provides access to view metrics from the devices, educational and clinical context content, and an asthma coach.
15944858|NCT03304054|Drug|Amifampridine Phosphate|tablets equivalent to 10mg amifampridine, titrated to an efficacious and tolerable dose, 3 to 4 times a day
15944859|NCT03304054|Drug|Placebo Oral Tablet|tablets matching amifampridine phosphate, 3 to 4 times a day
15944948|NCT03303274|Procedure|Ipsilateral tilt|The operation table will be tilted 20 degrees right laterally.
15944860|NCT03304041|Dietary Supplement|low-FODMAPs diet|"The low-FODMAPs diet(LFD) aims to keep oligosaccharides, fructose in excess of glucose, and polyol content at less than 0.5 g each per serving based on previously published data.
~low-FODMAPs diet therapy for 3 weeks"
15944861|NCT03304041|Dietary Supplement|Traditional dietary advice|"Traditional dietary advice(TDA) will focus more on how and when to eat rather than on what foods to ingest . Patients will be instructed to regularly eat, never too much or too little, never to be hungry or too full; to eat in peace and to chew thoroughly; reduce intake of fatty, spicy food, fiber, coffee and alcohol during the intervention period
~traditional dietary advice for 3 weeks"
15944862|NCT03304028|Device|Connected Devices for 3 months|Inclusion will be proposed at a follow-up visit by the child's or adult's referring doctor. A written informed consent form will be obtained. Quality of Life and Anxiety-Depression will be collected. Then, each included patient will be equipped with CDs-spirometer, oxymeter, scale and watch during 3 months for base-line.
15944863|NCT03304028|Behavioral|Educationnal Intervention|After a first statistical analysis and interpretation (5 months), alert parameters for each patient are then fixed. An educational visit will be scheduled with patients and a personnalized action plan will be defined..
15944864|NCT03304028|Device|Connected Devices for 12 months|Each included patient will be re-equipped with CDs-spirometer, oxymeter, scale and watch during 12 months. If alerts occur, patients will be informed by email or SMS, with data transmission to the medical team who will not interfere. Patients should apply the shared action plan they learned. Quality of Life and Anxiety-Depression will be collected.
15944865|NCT03304028|Other|Interviews|At the end, semi-structured interviews will be completed to explore confidence on the CDs, impact on the doctor-patient relationship, change in the workload of medical team…etc.
15944866|NCT03304028|Behavioral|Refusal Questionnaires|Clinic staff will email all patients or parents (pediatric settings) to introduce the study. A qualitative interview with 10 patients who declined to participate in the study will be conducted to identify the reason of refusal
15944867|NCT03304015|Behavioral|Behavioral Change Communications|HERrespect is developed by Business for Social Responsibility (BSR) and Change Associates. HERproject is one of BSR's numerous initiatives for improving women's lives through enhancement of access and knowledge (BSR, 2015). The factory-based component of HERrespect will be implemented by Change Associates. The intervention group will receive training (group session), research and consultancy services to the corporate and development sectors. HERrespect proposes to use the workplace as an incubator of dialogue among men and women to tackle underlying issues which allow violence against women and girls. Workplace offers a unique platform and environment to engage women who are gaining financial independence to reduce intimate partner violence and workplace violence.
15944868|NCT03304002|Other|Breast Cancer Surgery Decision Aid|We use a standard decision aid collaboratively developed by Health Dialog and the Informed Medical Decisions Foundation
15944869|NCT03303989|Drug|Pegloticase 8 MG/ML [Krystexxa]|Participants randomized to the pegloticase + MMF arm will start two week run-in on 1) mycophenolate mofetil at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period, Mycophenolate mofetil therapy will continue for 12 weeks at the highest tolerated dose. After the 12-week combination mycophenolate mofetil and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.
15944870|NCT03303989|Drug|MMF|Participants randomized to the pegloticase + MMF arm will start two week run-in on 1) mycophenolate mofetil at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period, Mycophenolate mofetil therapy will continue for 12 weeks at the highest tolerated dose. After the 12-week combination mycophenolate mofetil and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.
15944871|NCT03303989|Drug|Placebo|Participants randomized to the pegloticase + placebo arm will start two week run-in on 1) placebo at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period. After the 12-week combination placebo and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.
15944872|NCT03303989|Drug|Pegloticase 8 MG/ML [Krystexxa]|Participants randomized to the pegloticase + placebo arm will start two week run-in on 1) placebo at 500 mg/BID or the first week, titrating dose up to 1000mg/BID for the second week of run-in prior to the first infusion; and 2) Pegloticase 8 mg IV every two weeks following 2 week run-in period. After the 12-week combination placebo and pegloticase study period, participants will continue open label pegloticase therapy for an additional three months.
15944873|NCT03303976|Biological|Bioconjugate pneumococcal vaccine|Bioconjuagte vaccine against bacterial pneumococcal infection
15944874|NCT03303976|Biological|Multivalent plain polysaccharide vaccine|Multivalent plain polysaccharide vaccine against bacterial pneumococcal infection
15944875|NCT03303963|Diagnostic Test|Deeplex test, MolBio TrueNat for 2nd line, GeneXpert 2nd line|"Improvement of the diagnosis of Multi Drug Resistant-Tuberculosis patients with culture-free approaches. We have planned to diagnose Tuberculosis resistance to 1st and 2nd line drugs through novel molecular multiplex assays (Study 1) by:
~Validating the Deeplex test and establish a network for shipment of sputum samples in ethanol to regional reference laboratories (Study 1 - phase 1)
~Validating the Molbio Truenat test as a point of care test (Study 1 - phase 2)
~Validating the Cepheid GeneXpert 2nd line cartridge at the district level (Study 1 -phase2)"
15944876|NCT03303963|Diagnostic Test|Fluorescein DiAcetate (FDA) Microscopy,GeneXpert Ct value, pre-rRNA synthesis|"Improvement of the management of Multi Drug Resistant-Tuberculosis patients with culture-free approaches. We have planned to set up alternative culture-free approaches for the monitoring of patients' response to Multi Drug Resistant-Tuberculosis treatment (Study 2), with:
~FDA microscopy
~Measurement of bacterial load by following Cycle threshold (Ct) values in GeneXpert Mycobacterium tuberculosis/Rifampicin
~Measurement of pre-rRNA synthesis"
15946200|NCT03293680|Drug|Pembrolizumab|Pembrolizumab (MK-3475) 200 mg, every 3 weeks
15944882|NCT03303924|Drug|ETX2514 and sulbactam|Each subject will receive three doses of of ETX2514 1.0 g and sulbactam 1.0 g via intravenous (IV) infusion administered every 6 hours with each drug infused over 3 hours
15944883|NCT03303911|Drug|Cytisine|film-coated tablets; depending on arm assignment, 1 or 2 tablets to be taken with 240 mL water for each dose
15944884|NCT03303898|Procedure|Blood sampling|sampling of 7 blood tubes
15944885|NCT03303859|Diagnostic Test|Bacterial vaginosis|
15944886|NCT03303846|Procedure|Magnetic Resonance Imaging|Undergo high risk breast cancer screening MRI
15944887|NCT03303846|Procedure|Biospecimen Collection|Undergo blood and tissue sample collection
15944888|NCT03303846|Other|Laboratory Biomarker Analysis|Correlative studies
15944889|NCT03303833|Other|No intervention, observational study.|
15944890|NCT03303807|Device|Extracorporeal CO2 removal (ECCO2-R) (PrismaLung®, Prismaflex ® Baxter)|A low-flow CO2 removal device (Prismalung®, Baxter) will be used with a conventional renal replacement therapy (RRT) platform (Prismaflex®, Baxter). In patients already treated with continuous RRT because of renal failure or metabolic acidosis, the HF 1400® (Baxter) set will be used to combine RRT and decarboxylation. Gas flow through the gas exchanger will be set up to 10 L/min, with an oxygen concentration from 0.21 to 1 and a blood flow of 200-400 mL/min. Patients will be ventilated with a target tidal volume of 6 ml/kg (predicted body weight) and a target plateau pressure below 30 cmH2O.
15944891|NCT03303794|Drug|Exparel|1.3 % liposomal Bupivacaine in patients undergoing total knee arthroplasty
15944892|NCT03303794|Drug|0.25% bupivacaine|0.25% bupivacaine in patients undergoing total knee arthroplasty
15944893|NCT03303781|Other|Cardiac Rehabilitation|phase II center-based cardiac rehabilitation
15944894|NCT03303768|Diagnostic Test|Ultrasound|Investigation of relevant ultrasound signs to improve the antenatal diagnosis of coarctation of the aorta by calculating the sensitivity and specificity of these different signs
15944895|NCT03303742|Other|deep chamfer|finish line marginal design of a full coverage crown preparation
15944896|NCT03303742|Other|feather edge|finish line marginal design of a full coverage crown preparation
15944897|NCT03303729|Dietary Supplement|Meat Hydrolysate|25 grams of meat hydrolysate to maximally stimulate protein synthesis.
15944898|NCT03303729|Dietary Supplement|Cluster Dextrin|75 grams of Cluster Dextrin
15944899|NCT03303729|Dietary Supplement|Placebo|75 grams of Glucose
15944900|NCT03303703|Other|RENEwS|The intervention participants will meet with a trained interventionist for five 60-minute sessions as a group (two groups of five participants each). In the sessions time will be divided between didactic presentation of material, active practicing of techniques, group work focused on case studies, and worksheets for further practice at home. Topics covered within the intervention include emotional awareness, balancing emotional and physical wellbeing, selecting and implementing emotion regulation strategies (such as situation selections, mindfulness, engagement/avoidance, reappraisal, and emotional sharing), and emotional monitoring.
15944901|NCT03303690|Procedure|Ankle Spacer (AS)|All included patients will be treated by means of surgical implantation of the Ankle Spacer prosthesis in an open manner replacing the talar side of the tibiotalar joint.
15944902|NCT03303677|Drug|Saline Nasal|topical nasal saline rinses
15944903|NCT03303677|Drug|Budesonide Nasal|saline + budesonide nasal saline irrigation
15944904|NCT03303677|Drug|Topical Antibacterial (Product)|The antibiotic would be chosen based on intra operative culture sensitives as is our standard practice. The antibiotic would be selected from Levaquin, Vancomycin, Gentamicin, Ciprofloxacin, Mupirocin, and Trimethoprim/Sulfamethoxazole
15944905|NCT03303664|Other|IMPROVE Protocol|Comprehensive pain management protocol
15944906|NCT03303651|Procedure|Opioid administration in intervention groups|Elective surgery in radical open abdominal prostatectomy. Opioid titration is guided by analgesia indices during general anesthesia in the experimental arms.
15944907|NCT03303651|Procedure|Opioid administration in control group|Elective surgery in radical open abdominal prostatectomy. Opioid titration is guided by clinical signs in the control group.
15944908|NCT03303638|Behavioral|Multi-sensory Environment|Multi-sensory environments (MSE), also known as Snoezelen® environments, are defined as behavioral environmental intervention to help people with cognitive and physical impairments reach sensory equilibrium. Typical elements within MSE include visual, auditory, tactile and olfactory stimuli, ergonomic vibro-acoustic furniture, bubble tubes, color-changing LED lighting solutions, music, fiber optics and aromatherapy.
15944909|NCT03303625|Biological|Ad26.RSV.preF (1*10^11 vp)|Participants will receive two doses of 0.5 milliliter (mL) (1*10^11 vp) via IM route on Day 1 and 29 of Ad26.RSV.preF.
15944910|NCT03303625|Biological|Ad26.RSV.preF (5*10^10 vp)|RSV seropositive participants will receive two doses of 0.25 mL (5*10^10 vp) via IM route on Day 1 and 29 of Ad26.RSV.preF.
15944911|NCT03303625|Drug|Placebo|Participants will receive either 0.5 mL (cohort 0) or 0.25 mL (cohort 1) of placebo via IM route on Day 1 and 29.
15944912|NCT03303612|Device|Pacemaker implant|Patient will be in the electrophysiology laboratory. The doctor will freeze the groin area and a medication may be given to help the patient relax. A catheter will be inserted into the groin up to the heart and the heart's electrical system will be recorded.
15944913|NCT03303612|Device|Transcutaneous cardiac monitor|"Transcutaneous cardiac patches will allow continuous electrocardiographic monitoring for a 30-day period. For the first randomized patients at the Montreal Heart Institute, Icentia was used and then was changed to a m-Health® device which allows continuous cardiac monitoring. The PocketECG from m-Health® is attached to 3 electrodes on the chest and contains a SIM card that transmits to a server located in Burlington, Ontario .The COME-TAVI coordinating center and the associated site will be informed rapidly of any events that occur . These events include:
~Ventricular fibrillation; Sustained ventricular tachycardia Any RR interval >5 sec; Third-degree AV block or Mobitz 2 AV block;"
15944914|NCT03303586|Other|Compression Stockings|We will use knee length, ready-made compression stockings at a pressure of 20-30mmHg at the ankle and if a good fit cannot be obtained, custom-made stockings will be ordered. Patients will be measured for compression stockings by a certified fitter.
15944915|NCT03303586|Other|Control|Participants will not wearing compression stockings for two weeks.
15944916|NCT03303573|Drug|recombinant human erythropoietin|Subcutaneous rhEPO injection
15945427|NCT03299621|Device|PLE (Phase Lag Entropy)|Monitoring of PLE value using the monitoring of PLEM™ device during propofol anesthesia.
15944917|NCT03303547|Diagnostic Test|MRI mapping to guide pathological sampling of extranodal tumour deposits|Radiologist to mark areas where extranodal disease is identified on MRI. The pathologist will use this to take additional samples for analysis. This will allow better pathological staging and will affect treatment decisions for patients.
15944918|NCT03303534|Dietary Supplement|ScandiShake|weight gain supplement low in protein
15944919|NCT03303521|Drug|Placebo|"Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose) .
~Single dose contains from 1 to 3 sachets of Placebo depending on dose level assigned to a patient per non-dialysis days."
15944920|NCT03303521|Drug|Sodium Zirconium Cyclosilicate (ZS)|"Suspension administered orally for a treatment period of eight weeks (4 weeks of dose adjustment, 4 weeks in stable dose) .
~Single dose contains from 1 to 3 sachets of ZS 5g depending on dose level assigned to a patient per non-dialysis days."
15944921|NCT03303508|Diagnostic Test|anti-ds DNA|venous blood samples
15944922|NCT03303495|Biological|Bevacizumab|5 mg/kg intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on day 1 of a 2-week cycle.
15944923|NCT03303495|Drug|CPT-11|180 mg/m2 intravenously administered over 90 minutes on day 1 of a 2-week cycle
15944924|NCT03303495|Drug|5-FU Bolus|400 mg/m2 intravenous bolus on day 1 of a 2-week cycle.
15944925|NCT03303495|Drug|5-FU Infusion|2400 mg/m2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle.
15944926|NCT03303495|Drug|l-LV (dl-LV)|200 (dl-LV: 400) mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle.
15944927|NCT03303482|Behavioral|Enhancing Trauma Awareness (Diane Wagenhals, MEd-Lakeside Global Institute)|The trauma awareness professional development course is delivered in a small group (up to 16 participants; 2.5 hours every other week over 12 weeks). The course provides an environment for professionals to explore in depth the complex nature of trauma, while also recognizing and emphasizing the highly sensitive nature of trauma that is essential to becoming trauma-informed. The course facilitates a heightened awareness and appreciation for trauma-related behaviors and consequences that influence relationships and systems and that persist across generations.
15944928|NCT03303469|Drug|FMISO|FMISO PET/CT imaging at baseline
15944929|NCT03303469|Drug|FMISO|FMISO PET/CT post TACE
15944930|NCT03303469|Drug|FMISO|FMISO PET/CT post SBRT
15944931|NCT03303456|Other|Mobile health application - Ginger.io|the Ginger.io is a smartphone application allowing for daily surveys assessing mood and social interactions, and weekly surveys assessing symptoms and psychosocial functioning. Collects passive movement and interaction data
15944932|NCT03303430|Diagnostic Test|MRI|Diffusion weighted imaging 24 hours after revascularisation
15944933|NCT03303417|Diagnostic Test|MRI Scan|Participants will undergo hourly MRI scans on day 3 to assess bowel fluid content
15944934|NCT03303417|Other|Kiwifruit|Kiwifruit
15944935|NCT03303417|Other|calorie-matched sugar drink|calorie-matched sugar drink
15944936|NCT03303404|Device|Ambulatory (24-hour) Blood Pressure|Unlike casual blood pressure measurements, 24-hour ambulatory blood pressure monitoring provides an insight into blood pressure changes in everyday life and an estimate of the overall blood pressure load exerted on the cardiovascular system over 24 hours. Blood pressure recordings over a 24-hour period of normal daily activity will be made using a noninvasive ambulatory monitor (Spacelabs, Redlands, WA). The ambulatory system will be calibrated against a mercury sphygmomanometer, and the cuff will be programmed to inflate automatically every 15 min from 6 AM to 11 PM and every 20 min between 11 PM and 6 AM. For each individual subject, the nighttime period will be defined as the time when the subject goes to bed at night until rising in the morning. Daytime will be defined as the remainder of the 24-hour period. Daytime and nighttime states will be monitored by an Actiwatch (Mini-MItter, Bend, OR), a watch-like device placed on the wrist that measures gross motor activity.
15944937|NCT03303391|Other|Intradialytic Blood Pressure Slope Based Ultrafiltration|Algorithmic Determination of ultrafiltration based on intradialytic blood pressure slopes calculated at the beginning of each month from the prior two weeks of dialysis treatments
15944938|NCT03303378|Drug|melatonin (Helsinn Chemical Co, Biasca, Switzerland)|"Patients will receive a total intravenous melatonin (Helsinn Chemical Co, Biasca, Switzerland) dose of 11.61 mg (aproximately 166 μg/kg). The dose will be distributed in a volume of 500 ml of an isotonic and sterile solution of 100 μM melatonin during 150 min with a drip rate of 4.2 ml/min.
~The temporal distribution of perfusion will be: 30 min previous to percutaneous revascularization and remainder doses in a subsequent 120 min (1 h during the angioplasty +60 min post-intervention)."
15944939|NCT03303378|Drug|Placebos|The temporal distribution of perfusion will be: 30 min previous to percutaneous revascularization and remainder doses in a subsequent 120 min (1 h during the angioplasty +60 min post-intervention).
15944940|NCT03303365|Radiation|stereotactic radiosurgery (SRS)|"All patients will receive a pre-treatment cranial MRI for diagnostic and treatment planning purposes.
~In Arm A, the contrast-based T1-weighted SPACE sequence is utilized for GTV definition. In Arm B, the contrast-based T1-weighted three-dimensional MPRAGE sequence is utilized for GTV definition. In both cases the GTV consists of all contrasted tissue associated with the target lesion and all additional tissue judged by an experienced physician to be part of the suspect target lesion. To the GTV a PTV margin of 1 mm is added by isotropic expansion that can be slightly modified if deemed necessary by the treating physician (e.g. intersection with adjoining OAR).
~Dose prescription to the PTV for target lesions will be as follows:
~20 Gy to the 70%-isodose (lesions < 2 cm max. diameter)
~18 Gy to the 70%-isodose (lesions 2 - 3 cm max. diameter)
~6 x 5 Gy to the conformally surrounding isodose (lesions > 3 cm max. diameter)"
15944941|NCT03303352|Procedure|EUS FNA|Patients with solid pancreatic masses fulfilling the inclusion and exclusion criteria will be randomly allocated to receive EUS FNA (endoscopic ultrasound fine needle aspiration).
15944942|NCT03303339|Drug|Onvansertib|Onvansertib orally
15944943|NCT03303339|Drug|Cytarabine|subcutaneously
15944944|NCT03303339|Drug|Decitabine|intravenously
15944945|NCT03303326|Behavioral|Immediate interview|A women's health interview that obtains information about physical, mental, and sexual health, particularly relatively private sexual health-related attitudes and experiences, as well as conflicts and stress related to sexuality.
15944946|NCT03303313|Drug|Cemdisiran|Subcutaneous (sc) injection of Cemdisiran
15944947|NCT03303287|Behavioral|School health education|School health education program in Pakistan(SHEPP): The health education program will be directed towards children, parents and teachers
15944949|NCT03303248|Behavioral|Web-based Educational Intervention|A web-based educational tool, created for patients with congenital heart disease, will be given to patients using an ipad. This additional educational tool will be used with the standard of care visit with provider.
15944950|NCT03303235|Drug|Methylergonovine|IV vs IM
15944951|NCT03303222|Diagnostic Test|breath|measurement of volatile compounds, such as TMAO in exhaled breath and blood
15944952|NCT03303209|Other|Patient-centered opioid tapering protocol|All patients who entered the study agreed to partner with their pain physician on a patient-centered opioid tapering program. The research component of the study was to observe patient response (in terms of change in MEDD and pain intensity) at month 4.
15944953|NCT03303196|Device|Bihormonal Bionic Pancreas|A 4-day inpatient admission in which subjects will wear the bihormonal pancreas. The bihormonal pancreas will be placed upon admission and there will be 1 day of run-in. This will be followed by 3 days of data collection for comparison with the data obtained from the standard of care during the control admission.
15944954|NCT03303183|Device|Standard Impression technique|Silicone impression technique
15944955|NCT03303183|Device|Direct Ear Scanner|Direct Ear Scanner to scan the ear anatomy
15944956|NCT03303170|Device|Sebacia Microparticles|Topical microparticle suspension
15944957|NCT03303170|Device|Nd:Yag Laser|Laser delivering 1064 nm wavelength light
15944958|NCT03303157|Other|no intervention|not relevant
15944959|NCT03303144|Drug|Triferic|ferric pyrophosphate citrate
15944960|NCT03303131|Other|Discharge from community-based management|Comparison of patient characteristics and treatment outcomes between two groups
15944961|NCT03303118|Other|Hypoxia|No drug or product will be used in this study. No medication will be give to the participants. No arm will be used for product administration.
15944962|NCT03303105|Drug|TEV-48125|TEV-48125 will be administered subcutaneously once every 4 weeks.
15944963|NCT03303105|Drug|TEV-48125|TEV-48125 will be administered subcutaneously once every 12 weeks.
15944964|NCT03303092|Drug|TEV-48125|TEV-48125 will be subcutaneously administered once monthly for 3 months.
15944965|NCT03303092|Drug|TEV-48125 or placebo|TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months.
15944966|NCT03303092|Drug|Placebo|Placebo will be subcutaneously administered once monthly for 3 months.
15944967|NCT03303079|Drug|TEV-48125|TEV-48125 will be subcutaneously administered once monthly for 3 months.
15944968|NCT03303079|Drug|TEV-48125 or placebo|TEV-48125 or placebo will be subcutaneously administered once monthly for 3 months.
15944969|NCT03303079|Drug|Placebo|Placebo will be subcutaneously administered once monthly for 3 months.
15944970|NCT03303066|Drug|FG-4592|Oral
15944971|NCT03303066|Drug|Placebo|Oral
15944972|NCT03303053|Drug|Cholestyramine Powder 4g|Cholestyramine powder 4g twice daily, Tablet Carbimazole 30 mg daily, Tablet propanolol 40 mg twice daily for 4 weeks
15944973|NCT03303053|Drug|Prednisolone|Tablet prednisolone 30 mg daily for week 1, 20 mg daily for week 2, 10 mg daily for week 3 and 5 mg daily for week 4, Tablet carbimazole 30 mg daily, Tablet propanolol 40 mg twice daily for 4 weeks
15944974|NCT03303053|Drug|Standard treatment|Carbimazole 30 mg daily and propanolol 40 mg twice daily for 4 weeks
15944975|NCT03303040|Other|Electrical stimulation of hemidiaphragm|Electrical impulses
15944976|NCT03303027|Device|6-0 fast absorbing gut suture|Fast absorbing surgical gut suture is a strand of collagenous material, size 6-0
15944977|NCT03303027|Device|5-0 fast absorbing gut suture|Fast absorbing surgical gut suture is a strand of collagenous material, size 5-0
15944978|NCT03303014|Device|5-0 Prolene, 5-0 Fast Absorbing Gut|The interventions are two types of sutures: 5-0 Prolene, 5-0 Fast Absorbing Gut.
15944979|NCT03303001|Procedure|Subacromial high volume infiltration|This group will receive a high volume dose of a mix of methylprednisolone (40 mg in 2 mL) plus ropivacaine at 7.5% plus simple lidocaine plus saline solution for a total of 50 mL
15944980|NCT03303001|Procedure|Subacromial conventional infiltration|This group will receive a mix of solution of 2 mL of 40 mg of methylprednisolone plus 5 ml of ropivacaine at 7.5% plus 3 mL of lidocaine simple for a total of 10 ml
15944981|NCT03302988|Other|Everted closure|Suturing technique to obtain wound eversion. Type of suturing technique at surgeon's discretion
15944982|NCT03302988|Other|Planar closure|The planar side will be closed with traditional buried simple closure and running cuticular sutures
15944983|NCT03302975|Device|Real-time visual biofeedback during treadmill running|Real-time biofeedback of braking forces during running
15944984|NCT03302962|Behavioral|Intensive Asthma Education|"One half (54) of the identified cases were randomized to receive the previously established BREATHE study educational program, emphasizing patient-centered, self management of asthma. Periodic follow-up through personal contact and surveillance of IHS RPMS or other medical provider records was conducted."
15944985|NCT03302949|Dietary Supplement|Lacprodan® DI-8090|Whey protein concentrate. 100g powder contains 392 kcal (1646 kJ), hereof 80% protein.
15944986|NCT03302936|Drug|Phenazopyridine|to be given preoperatively
15944987|NCT03302923|Behavioral|Brisk walking|Prospective randomized clinical trial with 2 intervention groups and 1 control group.
15944988|NCT03302910|Other|Short Stay Unit|Subjects will be treated for acute heart failure in the SSU and observed for improvement then, if appropriate, discharged. If not appropriate for discharge they will be admitted to inpatient.
15944989|NCT03302910|Other|Standard of Care|Subjects who come to the ER with acute heart failure who are randomized to inpatient stay.
15944990|NCT03302910|Drug|Loop Diuretics|IV loop diuretics are commonly used in AHF management
15944991|NCT03302910|Drug|Nitroglycerin|Nitroglycerin or nitrovasodilators are commonly used in AHF management
15944992|NCT03302897|Biological|LEP-F1 + GLA-SE|Investigational vaccine
15944993|NCT03302884|Other|biological sampling|Tumor and blood samples
15944994|NCT03302871|Drug|Botulinum toxin type A|
15944995|NCT03302871|Device|transcranial direct current stimulation|
15944996|NCT03302871|Other|hybrid training model of CIMT and BIT|
15944997|NCT03302871|Other|usual care|
15945110|NCT03302013|Procedure|Vanguard CR Single Cruciate Retaining Knee System|Current 'gold standard' for total knee replacement which retains Posterior Cruciate Ligament but sacrifices the Anterior Cruciate Ligament, instead providing artificial support.
15944998|NCT03302858|Device|BARRX™ Anorectal Wand|"The radiofrequency ablation (RFA) or Barrx™ Ablation System used in this protocol comprises an RFA generator (Barrx™ FLEX) and the Barrx™ Anorectal Wand. The generator and wand are cleared by the FDA for human use and the wand is specifically cleared for treatment of anal neoplasia. The present FDA indication for use statement is: The Barrx™ catheters are indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including, but not limited to, the esophagus. Indications include esophageal ulcers, Mallory-Weiss tears, arteriovenous malformations, angiomata, Barrett's esophagus, Dieulafoy lesions, angiodysplasia, gastric antral vascular ectasia, and radiation proctitis."
15944999|NCT03302845|Drug|Omeprazole 40 MG|Omeprazole 40 mg capsule
15945000|NCT03302845|Drug|Famotidine 40 mg|Famotidine 40 mg tablet
15945001|NCT03302845|Drug|Telotristat ethyl 250 mg|Telotristat ethyl 250 mg tablet
15945002|NCT03302832|Other|Physical Therapy|Physical therapy includes both the in-person and home-based interventions prescribed for each individual participant in order to maximize overall patient outcomes including: ambulation, range of motion, strength, functional activities, pain, swelling, balance, patient safety, and other items within the scope of physical therapy practice.
15945003|NCT03302832|Other|In-home Exercise Equipment|The in-home exercise component of the study will supplement physical therapy services. This exercise equipment will be utilized daily for up to 90 minutes as guided by the healthcare team
15945004|NCT03302819|Diagnostic Test|MARIA scan|The patient will have an additional MARIA scan along with conventional imaging, pathology and surgical procedures.
15945005|NCT03302806|Other|Non interventional Study|
15945006|NCT03302793|Device|BreEStim|BreEStim will applied for 10 to 20 minutes.
15945007|NCT03302793|Device|tDCS|tDCS will be applied for 20 minutes.
15945008|NCT03302793|Device|tDCS sham|
15945009|NCT03302780|Device|BreEStim|BreEStim will applied for 10 to 20 minutes.
15945010|NCT03302780|Device|tDCS active|tDCS will be applied for 20 minutes.
15945011|NCT03302780|Device|tDCS sham|
15945012|NCT03302767|Other|Psychological and Social Consultation|Psychological and Social Consultation at Baseline, during the study and at the end of follow-up
15945013|NCT03302754|Drug|Alemtuzumab|Alemtuzumab (Campath®) is a recombinant DNA-derived humanized monoclonal antibody directed against CD52. Alemtuzumab is produced in mammalian cell (Chinese hamster ovary) suspension culture in a medium containing neomycin. Neomycin is not detectable in the final product. Alemtuzumab is a sterile, clear, colorless, isotonic pH 6.8-7.4 solution for injection. Alemtuzumab is supplied in single-use clear glass ampules containing 30 mg of Alemtuzumab in 3 mL of solution. Single use vial of alemtuzumab contains 30 mg alemtuzumab, 8 mg sodium chloride, 1.44 mg dibasic sodium phosphate, 0.2 mg potassium chloride, 0.2 mg monobasic potassium phosphate, 0.1 mg polysorbate 80, and 0.0187 mg disodium edetate dihydrate.
15945014|NCT03302741|Drug|Botulinum neurotoxin (BTX)|Each patient will receive BTX injections in 2 sites. 100 units at double dilution will be injected at each site.
15945015|NCT03302741|Other|Physical Therapy|Standard physical therapy will be ordered to both groups as part of standard of care for patients after BTX injections to maximize the outcomes.
15945016|NCT03302741|Device|Standard BTX injection (ultrasound guided)|For standard injection procedures, target muscles will be visualized under ultrasound imaging which is operated by an experienced and dedicated technician. Position of needle tip within the target muscle is visualized prior to injection. Ultrasound guidance can help ensure depth of needle tip location, i.e., to make sure the needle tip is within the muscle, but it is not able to tell where it is located with reference to the innervation zones (IZs) of the entire muscle.
15945017|NCT03302741|Device|3-dimensional innervation zone (3DIZ) guided injection|Simultaneous surface EMG and intramuscular EMG measurements will be acquired from the spastic biceps of the patients. Patients will be seated comfortably on a height-adjustable chair. The arm to be tested will be secured firmly on a customized apparatus with the elbow joint at approximately 90° of flexion and the shoulder at approximately 45° of abduction and 30° of flexion. The 128-channel unipolar surface EMG signals will be recorded with 2 flexible 2-dimensional 64-channel surface electrode array. A coating fine wire electrode will be inserted into the mid-axial section of the biceps to record bipolar intramuscular EMG signals. Ultrasound scan will be performed on the biceps to identify the location of the inserted wire electrode. Patients will be asked to contract their impaired biceps to perform maximum voluntary contraction of elbow flexion against the vertical plates 3 times.
15945018|NCT03302728|Drug|Lenalidomide 15mg|At commencement of study : Lenalidomide will commence at 15 mg daily for days 1-14 of each cycle. Maximum number of cycles = 16. This is a dose finding study so doses will be adjusted depending on toxicity assessment over the course of the study. Dose may vary from 5 mg -25 mg daily depending on dose escalation results and recommendation of safety committee
15945019|NCT03302728|Drug|Brentuximab Vedotin 1.8 mg/Kg|At commencement of study : Brentuximab vedotin 1.8mg/kg IV on day 1, repeated every 21 days. Maximum number of cycles = 16. This is a dose finding study so doses will be adjusted depending on toxicity assessment over the course of the study. Dose may be either 1.2 mg/Kg q21 days or 1.8 mg/kg q21 days depending on dose escalation results and recommendation of safety committee
15945020|NCT03302715|Genetic|Mucosal tissue sampling|Mucosal tissue sampling for DNA analysis
15945021|NCT03302702|Other|Exercise program|Exercise program including breathing control, pursed-lip breathing, diaphragmatic and thoracic breathing, aerobic and strengthening training
15945022|NCT03302689|Drug|Levobupivacaine Solution|TAP-block with Levobupivacaine 0,3% - 25 ml from each side
15945023|NCT03302689|Drug|Ropivacaine Solution|TAP-block with Ropivacaine 0,3% - 25 ml from each side
15945024|NCT03302676|Dietary Supplement|Chewing gum|
15945025|NCT03302663|Diagnostic Test|MRI scan|Addition of advanced imaging sequences for fetal MRI
15945026|NCT03302650|Drug|Angiotensin II|Patients will receive angiotensin-II at a starting dose of 20 ng/Kg/min.
15945027|NCT03302650|Drug|Normal saline|Patients will receive normal saline.
15945028|NCT03302650|Drug|Norepinephrine|patients will receive norepinephrine infusion adjusted according to blood pressure
15945111|NCT03302000|Other|Early Visual Stimulation|Early visual stimulation
15945112|NCT03302000|Other|standard care|standard care
15945113|NCT03301987|Other|Therapeutic exercise|30 minutes per day of therapeutic exercise
15946321|NCT03292666|Drug|Oral Anticoagulant|Oral anticoagulants used to treat or prevent venous thromboembolism
15945029|NCT03302637|Other|16S rRNA gene sequencing assay|extraction of genomic DNA from oral samples using the Mobio DNA Isolation Kit. 16S rRNA amplicons covering variable regions V3 to V4 will be generated using primers (347F-5'GGAGGCAGCAGTRRGGAAT'-3' and 803R 5'-CTACCRGGGTATCTAATCC-3')66 incorporating adapters and a sample barcode sequence at PI's lab. Amplicons will be sequenced with the Roche 454 FLX Titanium sequencing system at the NYU genome technology center, following the manufacturer's specifications.
15945030|NCT03302611|Behavioral|Physical Activity-based Interventions|Participants will be randomized to one of two physical activity-based interventions, surf or hike therapy.
15945031|NCT03302598|Diagnostic Test|serum C-reactive protein|
15945032|NCT03302585|Drug|Vitamin D3|50,000 IU/d of oral vitamin D3 x 5 days followed by 10,000 IU/d of oral vitamin D3 x 85 days
15945033|NCT03302585|Drug|Placebo/Standard of Care Vitamin D3|50,000 IU/d of oral vitamin D3 x 5 days followed by 40,000 IU/d of oral vitamin D3 x 85 days
15945034|NCT03302572|Other|Brief information group|Patients will be given oral brief information about the existence of advance directives after resolving the reason for the visit for which they had come. This information will not last more than 3 minutes and will not be repeated on successive visits within the recruitment period. Also, an informative triptych will be given to the patient so that he can read it at home. These leaflets have been made by the regional Department of Health. They will be advised that we can extend the information or help them to do the document in the near future if they want, we will inform that we would wait for the answer 3 months. In case of interest, they can leave their information in the User Service by specifying name, telephone number and reference doctor or ask for an appointment again.
15945035|NCT03302559|Other|Retinol Complex 0.5|Retinol Complex 0.5 topically in the evening.
15945036|NCT03302559|Other|Facial cleanser|Facial cleanser in the morning and in the evening.
15945037|NCT03302559|Other|Moisturizing lotion|Fragrance free moisturizing lotion in the morning and in the evening.
15945038|NCT03302559|Other|Sunscreen|Sunscreen broad spectrum sun protection factor (SPF) 35 topically in the morning and as needed.
15945039|NCT03302559|Device|Skin Imaging|Non-invasive in vivo skin imaging will be taken with the VivoSight Dx Optical Coherence Tomography (OCT) and VivaScope 1500
15945040|NCT03302546|Procedure|Incremental hemodialysis|Patients randomized to this arm of treatment will be treated during at least 4 hours of hemodialysis twice per week
15945041|NCT03302546|Procedure|Conventional hemodialysis|Patients randomized to this arm of treatment will be treated during at least 3.5 hours of hemodialysis three times per week
15945042|NCT03302533|Procedure|Total elbow arthroplasty|Implantation of a total elbow arthroplasty after distal humerus fracture
15945043|NCT03302520|Device|NovoMax, BioAlpha Inc, Seong-nam, Korea|CaO-SiO2-P2O5-B2O3 glass ceramics spacer
15945044|NCT03302520|Device|PEEK cage|PEEK cage
15945045|NCT03302507|Procedure|BESS|Biportal endoscopic surgery
15945046|NCT03302507|Procedure|ULBD|Unilateral laminotomy bilateral decompression
15945047|NCT03302494|Device|Coherex WaveCrest® Left Atrial Appendage Occlusion System|Percutaneous left atrial appendage closure
15945048|NCT03302494|Device|Watchman® LAA Closure Device|Percutaeous left atrial appendage closure
15945049|NCT03302481|Other|liver biopsy|the biopsies will be performed under laparoscopy and taken in the lower part of the right hepatic lobe
15945050|NCT03302455|Behavioral|eCBTI|The brief eCBTI contains a one-week core course: sleep hygiene education, sleep restriction, stimulus control, relaxation audios, cognitive components, information about sleeping pills, and a brief overview. In addition, individual customized sleep restriction and stimulation control treatments were provided according to the subject's previous 2-week sleep status.
15945051|NCT03302442|Other|Non interventional study|Not applicable - Non interventional Study
15945052|NCT03302429|Other|PRF/ BCP|Platelet rich fibrin combined with biphasic calcium phosphate(experimental group)
15945053|NCT03302429|Other|Autogenous bone graft|Bone obtained from the same individual who receiving the graft
15945054|NCT03302416|Drug|Hydrocortisone|
15945055|NCT03302416|Radiation|[C-11]NOP-1A|
15945056|NCT03302403|Genetic|CAR-CD19 T cell|"Self-controlled dose escalation and classic 3+3 dose escalation will be applied."
15945057|NCT03302403|Genetic|CAR-BCMA T cell|"Self-controlled dose escalation and classic 3+3 dose escalation will be applied."
15945058|NCT03302403|Genetic|CAR-GPC3 T cell|"Self-controlled dose escalation and classic 3+3 dose escalation will be applied."
15945059|NCT03302403|Genetic|CAR-CLD18 T cell|"Self-controlled dose escalation and classic 3+3 dose escalation will be applied."
15945060|NCT03302403|Drug|Fludarabine|Fludarabine is used for lymphodepletion.
15945061|NCT03302403|Drug|Cyclophosphamide|Cyclophosphamide is used for lymphodepletion.
15945062|NCT03302390|Procedure|Shave Biopsy of Psoriasis Lesion|The investigator will take about 0.5x0.5 inch square section of skin from the psoriasis lesion. To numb the skin, the subject will receive a small injection of 0.5% lidocaine HCl 5mg/mL with 1:200,000 mcg/mL epinephrine solution as per standard shave biopsy protocol. The shaving instrument has a blade that will shave off a superficial piece of skin that is less than <3mm in thickness. After 14 days, the subject will return to make sure that the skin biopsy site has healed properly. The piece of skin that is removed will be grafted onto the back of an immunocompromised SCID mouse. An approved IACUC protocol covering this procedure will be in place prior to engraftment.
15945063|NCT03302377|Behavioral|physical activity counseling & Fitbit|Participants will receive individual counseling & guidance in goal setting, then will receive a Fitbit wrist monitor and guidance in personalizing the Fitbit features
15945064|NCT03302364|Drug|Risperidone|patients who have never received risperidone or who have received re-administration of risperidone after discontinuation of risperidone treatment
15945065|NCT03302351|Drug|Dexmedetomidine|30 patients will receive intravenous dexmedetomidine 1 mcg/kg.
15945066|NCT03302351|Drug|ketamine|31 patients will receive intravenous ketamine 0.4 mg/kg.
15945067|NCT03302351|Drug|Dexmetedomidine+Ketamine|33 patients will receive combination between intravenous dexmedetomidine 0.5mcg/kg + low dose ketamine 0.25mg/kg.
15945068|NCT03302338|Drug|SAFE group|simulated amniotic fluid 20cc/kg/day enterally for a maximum of 7 days.
15945069|NCT03302338|Drug|placebo group|distilled water 20 ml/kg/day for maximum of 7 days.
15945597|NCT03298321|Other|Effect of Vidaza treatment|The goal of this study is to evaluate the effects of azacytidine on arrhythmia and left atrium fibrosis.
15945070|NCT03302325|Procedure|research blood draws|Twenty-five mL of peripheral blood (PB) will be collected for research. Blood will be collected in EDTA tubes and used to isolate ctDNA. For each subject we will request that he/she contribute 25 mL of plasma no more frequently than every 6 weeks, and at same time of standard of care blood draws and routine clinic visit, and for no more than 3 times (including baseline and end of study).
15945071|NCT03302299|Drug|Isoniazid 300 Mg ORAL TABLET|The study intervention will include a single arm given (1) 6H: 300 mg INH daily by mouth for 6 months.
15945072|NCT03302299|Drug|Pyridoxine 25 Mg Oral Tablet|All participants will also receive 25 mg pyridoxine (vitamin B-6) daily by mouth for 6 months for the treatment duration to reduce the risk of INH-induced peripheral neuropathy.
15945073|NCT03302286|Diagnostic Test|Heart-lung machine primining solution which includes Mannitol|This study group will undergo cardiopulmonary bypass with priming solution of Ringer's acetate 1000 ml, Mannitol 200 ml, Heparin 10000 units and 80 mmol sodium.
15945074|NCT03302286|Diagnostic Test|Heart-lung machine primining solution which does not include Mannitol|This study group will undergo cardiopulmonary bypass with priming solution of Ringer's acetate 1200 ml, Heparin 10000 units and 80 mmol sodium.
15945075|NCT03302273|Other|Corneal Epithelial Stem Cell Transplant|Self-administration of formulated topical eye drops containing cadaveric epithelial stem cell-derived biologic material.
15945076|NCT03302260|Behavioral|CardioPrevent® Program|This is a 1-year, evidence-based behaviour change lifestyle program that consists of 25 contacts (in person, by phone and in groups) with a trained lifestyle counsellor to facilitate desired lifestyle behaviours within the participants' own social context.
15945077|NCT03302247|Biological|Nivolumab|Monoclonal antibody against non small cell lung cancer
15945078|NCT03302247|Drug|Nivolumab+Gemcitabine|Gemcitabine is added to the Nivolumab treatment
15945079|NCT03302234|Biological|Pembrolizumab|Administered as an intravenous (IV) infusion every 3 weeks (Q3W)
15945080|NCT03302234|Biological|Ipilimumab|Administered as an IV infusion every 6 weeks (Q6W)
15945081|NCT03302234|Other|Placebo|Normal saline solution administered as an IV infusion Q6W
15945082|NCT03302221|Drug|0.5% ropivacaine paravertebral block|The investigators designed a study to assess whether there were any blood flow indexes change during induction with doppler ultrasonography after 0.5% ropivacaine paravertebral block
15945083|NCT03302221|Drug|0.25% ropivacaine epidural block|A 4-5 ml bolus of 0.25% ropivacaine was administered 1 h after the initiation of TEB.
15945084|NCT03302221|Drug|0.5% ropivacaine local anaesthesia|local anaesthesia at the incision was induced by 0.5% ropivacaine by the surgeon just before the surgery.
15945085|NCT03302208|Drug|Pregabalin|Pregabalin capsule 150 mg oral
15945086|NCT03302208|Drug|Placebo|Placebo
15945087|NCT03302195|Drug|Heparin|Based on patient body weight (UI/kg)
15945088|NCT03302195|Procedure|cardiopulmonary bypass pump flow rate|Based on patient body weight (L/min/m2)
15945089|NCT03302182|Drug|Ritonavir for cycle1 and NORVIR for cycle 2|During the study session, healthy subjects will be administered a single dose of Ritonavir Tablet 100mg in cycle 1 and NORVIR tablet 100mg in cycle 2 .
15945090|NCT03302182|Drug|NORVIR for cycle 1 and Ritonavir for cycle 2|During the study session, healthy subjects will be administered a single dose of NORVIR Tablet 100mg in cycle 1 and Ritonavir tablet 100mg in cycle 2 .
15945091|NCT03302169|Procedure|Radical prostatectomy with posterior rhabdosphincter reconstruction|To suture the Denonvilliers fascia and bladder to the median dorsal raphe according to Rocco technique.
15945092|NCT03302169|Procedure|Radical prostatectomy without posterior rhabdosphincter reconstruction|Standard technique with a running suture to perform the urethrovesical anastomosis
15945093|NCT03302156|Drug|PSMA-based 18F-DCFPyL PET tracer|PSMA-based 18F-DCFPyL PET tracer that will be used to determine the presence or absence of cancer
15945094|NCT03302143|Procedure|Guided bone regeneration with Bovine Bone Mineral|Guided bone regeneration with Bovine Bone Mineral
15945095|NCT03302143|Procedure|Guided bone regeneration with freeze dried bone allograft|Guided bone regeneration with freeze dried bone allograft
15945096|NCT03302130|Behavioral|Mood induction (using own memories)|Subjects deliver three positive, three negative and three neutral memories 30 seconds reliving a memory - answering questions about the memory - reliving memory for 2 minutes during ASL-MRI
15945097|NCT03302130|Device|Arterial spin labeling MRI|Single PLD PCASL
15945098|NCT03302130|Device|Physiological monitoring|During MRI: heart rate, end-tidal CO2, respiratory rate and skin conductance
15945099|NCT03302117|Other|Wood smoke exposure|Healthy volunteers will exposed to filtered air alternate with wood smoke generated from incomplete wood smoke combustion to assess the local and systemic effect of theses exposures
15945100|NCT03302091|Drug|BI 1467335|28 day treatment period
15945101|NCT03302078|Drug|BI 1015550|Fed state
15945102|NCT03302078|Drug|BI 1015550|Fasted state
15945103|NCT03302065|Drug|Tiotropium|
15945104|NCT03302039|Drug|Single shot phenylephrine|A single shot of phenylephrine (1.5 mcg/Kg) will be administrated intravenously.
15945105|NCT03302039|Drug|Fixed infusion phenylephrine.|Fixed infusion of phenylephrine will be administrated at a rate of 0.75 mcg/Kg/min
15945106|NCT03302039|Drug|Variable infusion phenylephrine.|Variable infusion of phenylephrine will be administrated at a starting rate of 0.75 mcg/Kg/min.
15945107|NCT03302039|Drug|Bupivacaine|Bupivacaine will be administrated in the subarachnoid space for spinal anesthesia.
15945108|NCT03302026|Behavioral|Realtime biofeedback using fMRI|Real-time fMRI (rt-fMRI) allows for rapid analysis of brain activation while an individual is actively performing a task, and can be used to provide real-time neurofeedback to individuals during fMRI scanning. Using neurofeedback, individuals can learn to modulate activity in specific regions of the brain. We propose to use rt-fMRI neurofeedback training to help smokers consciously modulate activation in areas related to cravings and self-control in order to improve control smoking urges. Participants will complete four sessions: an intake session and 3 scanning visits. The primary outcome is the ability to resist smoking during a validated smoking lapse paradigm.
15945109|NCT03302013|Procedure|Vanguard XP Bi-cruciate Retaining Knee Replacement System|Newer design of knee replacement retaining the Anterior Cruciate Ligament as well as the Posterior Cruciate Ligament.
15945211|NCT03301207|Drug|Midazolam|Midazolam 2 mg (1 milliliter [mL]) oral solution will be taken on Study Days 3 and 24 (as a part of CYP cocktail) and on Study Day 8 (alone).
15945114|NCT03301974|Procedure|conjunctival autograft with fibrin glue|Simple pterygium excision under local anesthesia performed then closure of the bare sclera by fibrin glued conjunctival autograft in 20 eyes of 20 patients (group 1).
15945115|NCT03301974|Procedure|sutured conjunctival autograft|Simple pterygium excision under local anesthesia performed then closure of the bare sclera by sutured conjunctival autograft in 20 eyes of 20 patients (group 2).
15945116|NCT03301974|Procedure|sutureless and glue-free conjunctival autograft|Simple pterygium excision under local anesthesia performed then closure of the bare sclera by sutureless and glue free conjunctival autograft in 20 eyes of 20 patients (group 3)
15945117|NCT03301948|Other|Overfeed|Participants consume energy intakes that are 50% higher than their estimated requirements instead of consuming energy intakes equal to their estimated requirements
15945118|NCT03301948|Other|Energy Balance|Participants consume energy intakes equal to their estimated requirements instead of consuming intakes that are 50% higher than their estimated requirements
15945119|NCT03301935|Procedure|Electrophysiology testing and exercise stress testing|Each patient will perform an exercise stress test on bicycle before an invasive electrophysiological test. Both examinations will be performed according to current Clinical practice.
15945120|NCT03301922|Behavioral|Metacognitive therapy and work-focused interventions|Metacognitive therapy and work-focused interventions, up to maximum 12 sessions, with weekly session of 45-60 minute duration. The metacognitive treatment program is based on Wells' manual. The work-focused intervention is based on Lagerveld and Blonk. The interventions are run in parallel.
15945121|NCT03301922|Other|Waiting list|Waiting list
15945124|NCT03301896|Drug|LHC165|LHC165 intratumoral injection
15945125|NCT03301896|Biological|PDR001|PDR001 infusion
15945130|NCT03301870|Drug|ATx201 Gel 2%|2% active gel
15945131|NCT03301870|Drug|ATx201 Gel 4%|4% active gel
15945132|NCT03301870|Drug|Positive Control|Sodium Lauryl Sulfate 0.05% (w/v), USP in sterile, distilled Water for Injection, USP
15945133|NCT03301870|Drug|Negative Control|Water for Injection, USP
15945134|NCT03301870|Drug|ATx201 Placebo|matching placebo gel
15945135|NCT03301857|Drug|Denosumab (Cohort A)|Cohort A: 120 mg administered subcutaneously (SC) every 4 weeks (Q4W).
15945136|NCT03301844|Combination Product|Blephapad Combo|"Blephapad Combo is used to cleanse, soften, sooth and decongest inflamed eyelids and cilia.
~The combo also presents an applicator with a heatable tablet that is applied to the eyelid in order to clean and open occluded Meibomian glands, thereby allowing the production of lipids necessary for a healthy tear film. The heatable tablet is to be used prior to cleansing with Blephapad wipes."
15945137|NCT03301844|Other|Standard treatment|Standard treatment, twice daily for one month, consisting in eyelid hygiene using wet, warm gauze.
15945139|NCT03301818|Device|Vaginal tactile imager|Patients will undergo elasticity assessment with vaginal tactile imaging the be once before surgical repair and twice after during a 3 month interval.
15945140|NCT03301805|Drug|BLEX 404|"BLEX 404 Oral Liquid is administered twice daily during the Gemcitabine monotherapy period. The dose of Gemcitabine 1,000 mg/m2 IV fusion at Day 1, 8, 15 of every cycle
~28 days a cycle."
15945141|NCT03301792|Behavioral|Group prenatal care|Enrolled subjects will be randomly assigned in a 2:1 ratio to group or traditional care.
15945142|NCT03301779|Device|Hemanext Red Blood Cell Processing System|Leukoreduced red blood cell product from donors in the Investigational Product arm will be processed in the Hemanext Oxygen Reduction Bag for 3 hours and then transferred to the Hemanext Storage Bag and stored for 42 days at 1-6°C.
15945143|NCT03301766|Drug|lidocaine 5% patch|transdermal patch
15945144|NCT03301766|Drug|standard therapy|Drugs prescribed at the discretion of the treating physician (acetaminophen, NSAIDs, muscle relaxants, etc)
15945145|NCT03301766|Drug|Non-medicated patch|non-medicated patch
15945146|NCT03301740|Other|UF profiling during HD|"Experimental arm: Linear UF profiling (linearly decreasing UF rate with a UF rate starting at 1.33 times the rate that would be needed at a constant UF rate to achieve the desired post-weight; pre-programmed profile 2 on a Fresenius 2008K machine, the machine used in all participating clinics). Ultrafiltration profiling will be performed using Fresenius 2008K dialysis machines in accordance with manufacturer instructions."
15945147|NCT03301740|Other|Conventional HD|Control arm: Conventional HD (routine care) is the participant's standard HD prescription without UF profiling.
15945148|NCT03301727|Other|Cognitive-Behavioural Therapy for Insomnia (CBT-I)|Cognitive-Behavioural Therapy for Insomnia (CBT-I) is an evidence-based psycho-therapeutic intervention, combining cognitive and behavioural principles to provide psycho-education concerning contributing thoughts to sleep problem maintenance, and behavioural technique instruction to reduce sleep onset latency and promote effective sleep maintenance.
15945149|NCT03301714|Behavioral|Oral Health Education|Group-based oral health education vs Individual-based oral health education using motivational interviewing
15945150|NCT03301701|Procedure|Radical prostatectomy|Radical prostatectomy
15945151|NCT03301701|Radiation|HDR (19Gy) or SBRT (35-40Gy)|Patients will receive HDR unless judged to medically unfit to undergo HDR brachytherapy, in which case they will receive SBRT
15945152|NCT03301688|Biological|Toripalimab|To compare the different drug batch number with different process
15945276|NCT03300648|Other|Mechanical ventilation|Intubation and mechanical ventilation for a maximum of 7 days
15945153|NCT03301675|Other|Orange Juice (500 mL/d)|Nutritionists prescribed the same balanced diet for both groups keeping suffice energy to maintain the current weight, estimated from total energy expenditure (TEE) for each individual and based on individual weight. The dietary plan was composed of six meals/day: breakfast (fat-free milk and coffee; whole-grain bread with margarine, and an apple); snack 1 (250 mL OJ/ banana or other fruits and free-fat yogurt); lunch (brown rice, beans, grilled lean meat, salad, cooked vegetables); snack 2 (250 mL OJ / free-fat yogurt with oatmeal); dinner (brown rice, beans, grilled lean meat, cooked vegetables and salad); and snack 3 (salty crackers or oat cookies, tea without sugar). Body composition measurements were colected every two weeks; blood samples and dietary questionnaires, monthly.
15945154|NCT03301662|Diagnostic Test|chest and thumb- ECG|chest and thumb- ECG using the Coala Heart Monitor
15945155|NCT03301649|Drug|Generic Ivermectin Lotion 0.5%|Topical lotion, generic formulation of the brand product.
15945156|NCT03301649|Drug|Sklice® (Ivermectin) Lotion 0.5%|Topical lotion, brand product.
15945157|NCT03301649|Drug|Vehicle Lotion|Topical lotion, placebo. Has no active ingredient.
15945158|NCT03301636|Drug|Pembrolizumab|Pembrolizumab will be administered intravenously every 3 weeks starting on day 1.
15945159|NCT03301636|Drug|Nivolumab|Nivolumab will be administered intravenously every 2 weeks starting on day 1.
15945160|NCT03301636|Drug|Indoximod|Indoximod will be administered orally every 12 hours starting at Day 1
15945161|NCT03301623|Other|Clinical Decision Support|The CDS intervention will test the use of existing guideline-based EHR alerts related to the prescription of opioids. CDS alerts employ computer algorithms that account for patient characteristics and diagnoses to deliver reminders of appropriate use when a provider enters an order for a medication.
15945162|NCT03301623|Other|Patient Education and Activation Tools|"The patient education materials selected for this study: Pain Management: Which Treatment is Right for You, Preparing for Your Health Care Visit, and a video from the American Chronic Pain Association (ACPA) named A Car with Four Flat Tires, which helps to give patients a better understanding of how multi-modal treatment can be more effective than relying on one source of treatment (e.g., pain medication)."
15945163|NCT03301610|Other|Mobile Education Delivery|Patients will be provided with an iPad on admission to the post-surgical unit and will remain with the patient until discharge. The patient, independently or with the nurse, may use the program at any point during the inpatient care experience. The RN will use the iPad to engage patients in their pain management.
15945164|NCT03301610|Other|Standard Verbal and Written Education|Patients will be provided with two pamphlets on pain management on admission to the post-surgical unit. Nurses will follow-up with verbal instruction based on patient need. This will continue through hospital stay. Additional printed education materials are available through the department of patient education and verbal instruction may be tailored based on nursing assessment and patient need.
15945165|NCT03301597|Biological|NLA101|"NLA101 is a universal donor off-the-shelf ex-vivo expanded hematopoietic stem and progenitor cell (HSPC) product that is cryopreserved and ready for immediate use."
15945166|NCT03301597|Drug|Standard of Care (SOC) chemotherapy|The SOC chemotherapy regimen for each patient will be determined by local PI. Regimen must be a standard AML regimen that will result in moderate to severe myelosuppression and have curative intent.
15945167|NCT03301584|Other|Enhanced collaboration to promote patient participation|"Enhanced OT and PT collaboration: to promote patient participation. Goal setting using TLS-BasicADL protocol. Patients were encouraged to consider activities important to them to be able to perform at discharge. Adaption of goals throughout the hospital stay.
~Supporting patient self-efficacy: by challenging patients' fear of falling and encouraging progression of exercise.
~Training kit with instructions: To increase activity and encourage patients to take more responsibility for their training.
~Enhanced exercise with protocol: More intensive training of transfers, walking, balance and P-ADL was offered at least 3 times/day by OT and PT.
~Collaboration meetings: twice weekly interdisciplinary meetings plus daily OT and PT logistic meeting to schedule treatment."
15945168|NCT03301584|Other|Usual Care treatment|The control group received standard rehabilitation from occupational therapists and physiotherapists (Monday to Friday), planned individually and gradually progressed for each patient. Mobilisation was initiated within 24 hours after surgery, 7 days a week. Patients were provided with a booklet with information about the fracture, operation method, exercise regime and assistive walking and ADL aid available.
15945169|NCT03301571|Other|Change in preload and afterload|Afterload: Three levels of positive end-expiratory pressure (PEEP) will be examined post-operatively: 0 cm H20, 5 cm H2O, 10 cm H2O Preload: Trendelenburg position for 5 minutes will be investigated
15945170|NCT03301571|Other|Inspired oxygen|Following fractions of inspired O2 will be investigated: 0.5 and 1.0 for 10 minutes respectively
15945171|NCT03301571|Other|Pacemaker mode|Following pacemaker settings will be investigated: Atrioventricular pacing 10 bpm over the patients' intrinsic rhythm, atrial pacing 10 bpm over the patients' intrinsic rhythm, ventricular pacing 10 bpm over the patients' intrinsic rhythm
15945172|NCT03301558|Drug|Low dose sodium bicarbonate|1500 mg sodium bicarbonate
15945173|NCT03301558|Drug|High dose sodium bicarbonate|3000 mg sodium bicarbonate
15945174|NCT03301545|Procedure|Fast-Track to Bariatric Surgery|30 participants from the urban Indigenous community who have Type 2 diabetes and are candidates for bariatric surgery at the Centre for Metabolic and Bariatric Surgery will be randomized to the fast-track to bariatric surgery group.
15945175|NCT03301532|Drug|Triheptanoin|Dietary supplementation with triheptanoin
15945178|NCT03301493|Other|Genomic testing|Genomic profiling, indicated as assessed by the medical need and as deemed appropriate by the physician according to routine practice
15945179|NCT03301467|Drug|Avacopan|Orally administered
15945180|NCT03301467|Drug|Avacopan Matching Placebo|avacopan matching placebo
15945181|NCT03301454|Drug|pursuit of chemotherapy|Treatment with LV5FU2 (5-FU, Calcium Levofolinate) - paclitaxel, regular tumor evaluation, best supportive care Other authorized treatment : usual paclitaxel pre-treatment consisting of Dexamethasone, Chlorpheniramine and ranitidine, at 15 and 1 day before the actual paclitaxel treatment
15945277|NCT03300648|Drug|Hypertonic saline|Intravenous 3 percent hypertonic saline for a maximum of 7 days
15945182|NCT03301441|Other|questionnaire ef-ID Migraine|"All consecutive patients eligible to the study will be included within 7 days of their initial admission, and evaluated with a short questionnaire classifying them as migrainers whose status will undergo a detailed validation at 3 months by a migraine expert, and non-migrainers whose status will be validated by repeating the short questionnaire at the follow-up visit at 3 months.
~Initial multimodal imaging, done routinely in any stroke patient, will acquire the raw data necessary to calculate the mismatch ratio (MRI DWI/PWI or CT rCBF/CTP). All radiological data will be analyzed centrally after the end of the recruitment, by investigators blinded to the migraine status."
15945183|NCT03301428|Other|Retrain pain educational website|Patients in this group will be invited to consult an educational website developped for patients with chronic pain
15945184|NCT03301428|Other|Booklet|Patients in this group will be invited toread an educational booklet developped for patients with chronic pain
15945186|NCT03301402|Device|Air purifier|Air purifier with filter at automatic mode on all time
15945187|NCT03301389|Other|Cardiac magnetic resonance imaging|The cardiac imaging protocol will include pre-contrast T1, post-contrast T1, and T2 mapping images acquired of the mid ventricle with the short axis plane for the analysis of native T1, T2, and extracellular volume (ECV) values of the myocardium. It will also include cine imaging covering the whole LV myocardium in the short axis plane for a functional analysis of the LV myocardium.
15945188|NCT03301363|Device|CRT|Subjects scheduled to be implanted for CRT by a Quadripolar Pacing System
15945189|NCT03301350|Drug|Carboplatin|Carboplatin is a platinum compound alkylating agent which covalently binds to DNA; interferes with the function of DNA by producing interstrand DNA cross-links.
15945190|NCT03301350|Drug|Paclitaxel|Paclitaxel promotes microtubule assembly by enhancing the action of tubulin dimers, stabilizing existing microtubules, and inhibiting their disassembly, interfering with the late G2 mitotic phase, and inhibiting cell replication. In addition, the drug can distort mitotic spindles, resulting in the breakage of chromosomes. Paclitaxel may also suppress cell proliferation and modulate immune response.
15945191|NCT03301350|Drug|Doxorubicin|Inhibition of DNA and RNA synthesis by intercalation between DNA base pairs by inhibition of topoisomerase II and by steric obstruction. Doxorubicin intercalates at points of local uncoiling of the double helix. Although the exact mechanism is unclear, it appears that direct binding to DNA (intercalation) and inhibition of DNA repair (topoisomerase II inhibition) result in blockade of DNA and RNA synthesis and fragmentation of DNA. Doxorubicin is also a powerful iron chelator; the iron-doxorubicin complex can bind DNA and cell membranes and produce free radicals that immediately cleave the DNA and cell membranes.
15945192|NCT03301350|Drug|Cyclophosphamide|Cyclophosphamide is an alkylating agent that prevents cell division by cross-linking DNA strands and decreasing DNA synthesis. It is a cell cycle phase nonspecific agent. Cyclophosphamide also possesses potent immunosuppressive activity. Cyclophosphamide is a prodrug that must be metabolized to active metabolites in the liver.
15945193|NCT03301350|Drug|Pegfilgrastim|Pegfilgrastim provides growth factor support in a single dose. It stimulates bone marrow to create neutrophils for patients undergoing chemotherapy.
15945194|NCT03301350|Drug|Filgrastim|Filgrastim provides growth factor support in multiple doses. It stimulates bone marrow to create neutrophils for patients undergoing chemotherapy.
15945195|NCT03301337|Dietary Supplement|Meat protein absorption|Meat protein absorption when digested together with a full meal.
15945196|NCT03301324|Device|Intubation Assist Dashboard|The ZOLL X Series Intubation Assist Dashboard feature guides the operator through a three-step auscultation process to verify the proper placement of an endotracheal tube.
15945197|NCT03301311|Other|Specific Carbohydrate Diet (SCD)|Patients will be randomized to start with either a strict SCD or modified SCD. Participants will alternate between each diet in 8-week intervals for a total duration of approximately 34 weeks. Participants will complete two 8-week intervention periods on each diet.
15945198|NCT03301311|Other|Modified Specific Carbohydrate Diet (MSCD)|Patients will be randomized to start with either a strict SCD or modified SCD. Participants will alternate between each diet in 8-week intervals for a total duration of approximately 34 weeks. Participants will complete two 8-week intervention periods on each diet.
15945199|NCT03301298|Drug|SXC-2023|Oral capsule
15945200|NCT03301298|Drug|Placebo oral capsule|Placebo given as oral capsule.
15945201|NCT03301285|Drug|Zoledronic Acid|Treatment of osteoporosis
15945202|NCT03301272|Drug|Onabotulinumtoxin A Injection|Reconstituted 10 units/0.1 mL. Administered intramuscular once
15945203|NCT03301272|Other|Placebo|0.9% normal saline solution, mimicking Botox injection paradigm. Administered intramuscular once.
15945204|NCT03301259|Other|One-shape rotationary system|OneShape (MICRO-MEGA) rotary nickel-titanium use roation movement and available in two sizes N°30 - .06 rotary files. , N°25 - .06
15945205|NCT03301246|Device|Artimes Pro Low Profile Dilatation Catheter|Pre-dilation catheter for the purpose of preparing the vessel to deliver the final therapy.
15945206|NCT03301233|Drug|estradiol valerate and sildenafil|(45 women will receive clomiphene citrate (clomid 50mg ®, Sanofi aventis) 2 tab. single dose orally from the 2nd day of the cycle for 5 days with oral estradiol valerate (Cyclo-Progynova ® 2mg, white tablets, BAYER Schering Pharma), one tablet every 12 hour from 2nd day of the cycle + sildenafil (silden® 25, E.I.P.I.CO.) every 8 hour from 2nd day of the cycle till the day of trigger of ovulation).
15945207|NCT03301220|Drug|Daratumumab SC: daratumumab + rHuPH20|Participants will receive daratumumab SC injection (daratumumab 1800 mg + rHuPH20 [2000 U/mL]) once weekly for Cycles 1 and 2 (Days 1, 8, 15, and 22 of each week), every 2 weeks for Cycle 3 to Cycle 6 (Days 1 and 15), and thereafter every 4 weeks (Day 1) until 39 cycles or up to 36 months or until confirmed disease progression, unacceptable toxicity or withdrawal from the study treatment, study termination or study completion. Each cycle is 28 days in duration.
15945208|NCT03301207|Drug|Ibrutinib|Ibrutinib capsule (at dose of 420 or 560 mg) will be taken orally QD.
15945209|NCT03301207|Drug|OC: Ethinylestradiol (EE) 30 mcg and Levonorgestrel (LN) 150 mcg|Single dose of oral contraceptives (OC) (1 tablet containing 30 mcg EE and 150 mcg LN) will be taken orally on Study Days 1 and 22.
15945210|NCT03301207|Drug|Bupropion|Bupropion 75 mg tablet as a part of CYP cocktail will be taken on Study Days 3 and 24.
15945278|NCT03300635|Other|Mental distress and relaxation test|
15945279|NCT03300635|Other|Glucose tolerance test|
15945212|NCT03301194|Other|RAMP-HT|RAMP-HT was launched since October 2011 by the Hospital Authority with the support from the Food and Health Bureau. Standardized cardiovascular risk factor assessment, hypertensive complication screening and assessment on patient adherence to treatment are carried out on enrolled patients. Patients are stratified into low, medium or high risk groups according to the 10-year cardiovascular disease (CVD) risk calculated from their relevant risk factors by the Joint British Society 2005 Equation. A multidisciplinary team comprised of doctors, nurses, dieticians, physiotherapists and/or occupational therapists would then deliver individualized management targeted to the patient's risk factors according to standardized risk-stratified guidelines.
15945213|NCT03301181|Drug|BGB-3111 (Arm A)|320 mg BGB-3111 single oral dose
15945214|NCT03301181|Drug|Rifampin|600 mg rifampin once daily
15945215|NCT03301181|Drug|BGB-3111 (Arm B)|Up to 80 mg BGB-3111 single oral dose
15945216|NCT03301181|Drug|Itraconazole|200 mg itraconazole once daily
15945217|NCT03301168|Biological|BPX-501 T cells|T cells transduced with CaspaCIDe® safety switch
15945218|NCT03301168|Drug|Rimiducid|administered to inactivate BPX-501 cells in the event of GVHD
15945219|NCT03301155|Drug|Anaferon for children|Tablet for oral use.
15945220|NCT03301155|Drug|Placebo|Tablet for oral use.
15945221|NCT03301142|Procedure|Laser|The patients will be submitted to application of the Erbium Laser: YAG(yttrium aluminium garnet) 2940nm, SMOOTH mode developed by FOTONA.The vaginal canal will be accessed using a specific speculum. The 90 degree laser tip shall be used to perform 4 applications to the anterior and lateral vaginal wall at each of the 5 clock points (9,10:30,12,1:30,3 'o´-clock´), commencing at the back of the vagina, retracting in increments of 0.5cm, where 4 shots are made at each interval up to a distance 1cm short of the external opening of the urethra. After completion of this stage, the 90 degree tip shall be switched for the 360 degree tip, whereupon 4 additional applications shall be performed with 4 shots every 0.5 cm along the vaginal trajectory outlined above.
15945222|NCT03301142|Procedure|kinesiotherapy|"Patients will be guided by the physiotherapist to perform exercises to strengthen the pelvic floor muscles at home on a daily basis in the supine position with an empty bladder. It will be performed 10 repetitions of five-second contractions, the 15 three-second contractions; 20 two seconds contractions; 20 contractions of a second; 5 repetitions of strong contractions while coughing; 10 repetitions of exercise bridge associated with pelvic floor contraction and relaxation up in descending.The level of difficulty in performing the exercises will be determined in accordance with the adopted position. In .changes position should be held every four sessions."
15945223|NCT03301129|Behavioral|Smoke|See arm/group descriptions.
15945224|NCT03301116|Behavioral|Healthy Moves for Aging Well (Healthy Moves)|A safe physical activity program which consists of a brief motivational enhancement and three movements to be performed in a seated position. The intervention will be delivered by home care aides for their clients.
15945225|NCT03301116|Behavioral|Active Mind for Aging Well (Active Mind)|A word puzzle program which consists of a brief motivational enhancement and word search activities. The intervention will be delivered by home care aides for their clients.
15945226|NCT03301103|Biological|E. coli strain E1392-75-2A|After an overnight fast, subjects will be orally infected with a live, but attenuated, diarrheagenic E. coli (strain E1392-75-2A; collection NIZO food research; dose 1E10 CFU (at study day 14).
15945227|NCT03301103|Device|PTM202|PTM202 is a dietary formula containing a proprietary mixture of dried bovine colostrum and dried whole egg.
15945228|NCT03301090|Other|Placebo|Placebo
15945229|NCT03301090|Biological|REGN3048|REGN3048 is a fully monoclonal antibody (mAbs) which binds to the S protein of MERS-CoV.
15945230|NCT03301090|Biological|REGN3051|REGN3051 is a fully human monoclonal antibody (mAb) which binds to the S protein of MERS-CoV. It can reduce virus titers and ameliorate MERS-CoV-induced lung pathology when given post infection.
15945231|NCT03301077|Other|2-phase epidemiological study (screening, interviews)|first phase is the screening phase, second phase is the interview phase
15945232|NCT03301064|Behavioral|Motivational Enhancement Therapy and Strengths Based Case Management (MET/SBCM)|Key objectives of the intervention are as follows: (1) identify health and personal goals and develop discrepancies between goals and current actions, (2) provide feedback related to risks associated with the participant's drinking (e.g., driving after drinking, liver disease), (3) provide normative feedback about the participant's pattern of drinking to alcohol use in the US among Latinos in the participant's age and gender group, (4) discuss reasons for drinking (e.g., feeling isolated from family, machismo, low status employment), (5) weigh the pros and cons of drinking and reasons to reduce drinking (e.g., to better provide for the family, improving family relationships), (6) negotiate a plan for reducing drinking and/or seeking help, (7) recognize personal strengths in the process of change (e.g., religiosity, desire to provide for family), and (8) identify needed social and health services and explore potential barriers (e.g., transportation).
15945233|NCT03301064|Other|Alcohol education brochure|The alcohol education brochure will address health risks associated with alcohol use and will provide information on low-risk drinking.
15945234|NCT03301051|Biological|Quadrivalent VLP Vaccine|Single dose of a 30 µg/strain of Quadrivalent VLP Vaccine
15945235|NCT03301051|Biological|Placebo|Single dose of a Placebo
15945236|NCT03301038|Drug|Rifampin|Rifampin 5 mg/kg (max 300 mg) daily for 8 weeks, followed by rifampin 10 mg/kg (max 600 mg) daily for 8 weeks.
15945237|NCT03301025|Drug|Pregabalin|Pregabalin 150 mg capsule, one h preinduction of general anesthesia
15945238|NCT03301025|Drug|placebo|given a placebo identical capsule once one hour before anesthesia
15945239|NCT03301012|Other|Recovery support as usual|same as arm
15945240|NCT03301012|Other|Smartphone assisted relapse prevention|same as arm
15945241|NCT03300999|Dietary Supplement|ginger tea|"1. Ginger tea - Swanson Organic: 100% Certified Organic Ginger Root Tea
~• Subjects will use one tea bag (contains two grams ginger root), mix with eight ounces of boiling water, steep for three minutes, and allow it to cool to room temperature before drinking. This will be done every day for one month before their third menstruation cycle and during their third menstruation cycle."
15945242|NCT03300973|Procedure|sling surgery|transoburator vaginal tape ,inside out procedure under spinal anathesia
15945243|NCT03300960|Drug|Provera 10 mg.|One 10 mg tablet of MPA (Medroxyprogesterone acetate) is administered every 24 hours from the onset of Controlled Ovarian Stimulation (COS), until the day of triggering.
15945280|NCT03300635|Other|Exercise test|
15945244|NCT03300960|Drug|Ganirelix (GnRH antagonist)|One ampoule of Ganirelix (GnRH antagonist) a day once diameter of follicles are 14 mm diameter on average until triggering.
15945245|NCT03300947|Drug|Psilocybin 100 mcg/kg|"Psilocybin belongs to the class of hallucinogen or psychedelic drugs. It is one of the major psychoactive components in mushrooms of the Psilocybe genus (magic mushrooms)."
15945246|NCT03300947|Drug|Psilocybin 300 mcg/kg|"Psilocybin belongs to the class of hallucinogen or psychedelic drugs. It is one of the major psychoactive components in mushrooms of the Psilocybe genus (magic mushrooms)."
15945247|NCT03300947|Drug|Lorazepam 1 mg|A medication used to treat anxiety belonging to a class of drugs known as benzodiazepines, which act on the central nervous system to produce a calming effect. This drug works by enhancing the effects of a certain natural chemical in the body (GABA).
15945248|NCT03300934|Device|closed loop glucose control system|Cross over between Closed loop glucose system with DANA pump, Navigator II CGM and Cambridge AP algorithm FD2A, versus usual CSII pump treatment
15945249|NCT03300921|Drug|Paricalcitol|"Product: Paricalcitol
~Dose/Route/Regimen:
~Arm A: 50mcg IV weekly Arm B: 12mcg PO daily"
15945250|NCT03300908|Behavioral|Project ADHERE|"This is a 3-session ART medication adherence and risk reduction intervention. Participants are educated about the importance of staying healthy and taking their medication as prescribed; to discuss importance of improved immune functioning and what their viral load means; reminded that they can still infect others with HIV, and that there currently is no cure for HIV; expected to generate strategies to overcome adherence barriers; educated about sexually transmitted infections (STI)/HIV transmission modes; assisted in devising an appropriate medication adherence and risk reduction plan. Participants will report their progress and discuss challenges experienced when implementing their medication adherence and risk reduction plans while establishing short- and long-term goals."
15945251|NCT03300908|Behavioral|MACE|This one-session medication adherence intervention covers the following content: 1) a discussion on what viral load represents and what HIV does to the body; 2) referral to a provider for participants without a provider; 3) the importance of maintaining regular contact with a health care provider; and 4) benefits of being retained in care.
15945252|NCT03300895|Other|High-intensity interval training|21.5 minutes of high-intensity interval exercise at an intensity between 90-95 of HRmax (15x30 s), with recoveries at 50-60% of HRmax (14x60 s). 24 sessions, 3x weekly of walking and running outdoors on a sports field in a supervised manner.
15945253|NCT03300895|Other|Comparator: Moderate-intensity continuous exercise|30 minutes of continuous exercise at an intensity between 65-75% of HRmax. 24 sessions, 3x weekly of walking and jogging outdoors on a sports field in a supervised manner
15945254|NCT03300882|Other|Procedure|Serial blood draws. Participants will be enrolled either pre-transplant or within 45 days post-transplant and will be followed over the course of 18 months post transplant. Protocol mandated serial measurement of cytomegalovirus (CMV)-specific immune signature will occur pre-transplant (as applicable) and at post-transplant timepoint months 2, -3, -6, -9, -12 and -18.
15945255|NCT03300843|Biological|Peptide loaded dendritic cell vaccine|On days 0, 14 (+/- 5 days), 28 (+/- 5 days), and 42 (+/- 5 days). The vaccine will be administered as both an intravenous (IV) infusion and a subcutaneous (SQ) injection. The total dose will be divided equally between intravenous (IV) and SQ containing 1.0E7 to 8.0E7 cells per cycle depending upon the manufacturing yield.
15945256|NCT03300817|Other|Laboratory Biomarker Analysis|Correlative studies
15945257|NCT03300817|Biological|MUC1 Peptide-Poly-ICLC Vaccine|Given SC
15945258|NCT03300804|Drug|20-herb formulation|Two daily dosages will be investigated. The lowest dosage condition will be 17gm daily, followed by an escalation to 34gm. Participants will be treated for 8 weeks
15945259|NCT03300804|Drug|Placebo|Placebo herb formulation
15945260|NCT03300791|Other|Admitted|Readmitted patients in the next months after an episode of aute heart failure will be recruited. Controls will be selected between those who were admitted in the baseline but not readmitted in this month.
15945261|NCT03300778|Behavioral|aerobic exercise|Running at the intensity of 50%-70% of maximum heart rate (220-age) for 30 mins per day, 4 days per week, last for 3 months
15945262|NCT03300778|Behavioral|Placebo controlled group|6 sections of group activities: 3 sections of general psychological education; one section of group game, one section of group poetry reading activity, group singing entertainment.
15945263|NCT03300765|Drug|Apatinib|Apatinib will be used as induction therapy in experimental arm.
15945264|NCT03300765|Radiation|Intensity modulated radiation therapy|Intensity modulated radiation therapy will be used for patients with progression disease during induction therapy or after induction therapy.
15945265|NCT03300752|Behavioral|BREATHE Intervention|PCPs randomized to BREATHE will receive the tablet which, when the screen is advanced by the PCP, will prompt the PCP through a 7-minute, 4-step brief intervention tailored to respond to the patient's specific beliefs, and shared decision-making discussion of asthma control status and treatment.
15945266|NCT03300752|Behavioral|Control Intervention|PCP will provide discussion of healthy lifestyles.
15945267|NCT03300726|Diagnostic Test|CSF analysis|CSF analysis for tau, p-tau181, Abeta42, and CSF levels of markers of synaptic injury
15945268|NCT03300726|Radiation|Functional MRI|Functional MRI during resting state and semantic memory task activation
15945269|NCT03300713|Other|MOCITRAINING program|The program is clinical and psychometric tools for screening for interactions and postpartum psychiatric disorders. The program will expose the existing care arrangements and the different possible orientations of the families according to the identified problem.
15945270|NCT03300713|Other|usual follow-up|usual follow-up
15945271|NCT03300687|Drug|FX-322|intratympanic injection
15945272|NCT03300687|Drug|Placebo|intratympanic injection
15945273|NCT03300674|Drug|Hydromorphone|Hydromorphone intravenous infusion
15945274|NCT03300674|Drug|Lidocaine|Lidocaine intravenous infusion
15945275|NCT03300661|Behavioral|Mediterranean Style|After completion of a Food Frequency Questinnaire (FFQ) and the International Physical Activity Questionnaire (IPAQ), patients enrolled in the study undergo a personalized educational intervention by a registered dietician. During the intervention the dietician advice about the main errors in diet and physical activity (by FFQ and IPAQ) and chooses three aims in diet modification and one aim in physical activity improvement. Patients adherence is assessed by the same dietician every three months, using FFQ and IPAQ, and futher supports are provided. Total intervention lenght is twelve months.
15945288|NCT03300596|Behavioral|Brief intervention to prevent suicide attempt|A patient-centered, 3-session intervention that calls for videotaping the narrative story of a patient's suicide attempt, in his/her own words (session 1); reviewing segments of the tape to arrive at a shared understanding of the attempt and the sequence of events that led to it (session 2); and using this information, along with a homework task completed by the patient in-between sessions, in order to develop a collaborative, comprehensive written safety plan that addresses the patient's unique vulnerabilities (session 3).
15945289|NCT03300596|Behavioral|Enhanced treatment as usual|Safety procedures' control intervention. For these procedures we will share summary results of the research assessments regarding suicidal thoughts, suicidal behaviors, alcohol and drug use and related problems, and depressive symptoms with appropriate hospital clinical staff. We will also arrange to send this information, with participants' permission, to their ongoing therapist or treatment program and, if none exists, to the therapist or program to which they are being referred. In this regard, the research assessment protocol serves a dual function of helping with additional monitoring of high-risk patients in addition to providing data for the study.
15945290|NCT03300583|Behavioral|Focus groups|Focus group discussion led by the PI and facilitated by another researcher.
15945291|NCT03300583|Behavioral|Semi-structured interviews|1:1 semi-structured interviews led by the PI
15945292|NCT03300570|Drug|Dolcanatide|Given PO
15945293|NCT03300570|Other|Laboratory Biomarker Analysis|Correlative studies
15945294|NCT03300570|Other|Placebo Administration|Given PO
15945295|NCT03300570|Other|Questionnaire Administration|Ancillary studies
15945296|NCT03300557|Drug|Exemestane|Given PO
15945297|NCT03300557|Other|Laboratory Biomarker Analysis|Correlative studies
15945298|NCT03300557|Other|Pharmacokinetic Study|Correlative studies
15945299|NCT03300557|Other|Questionnaire Administration|Ancillary studies
15945300|NCT03300544|Drug|Capecitabine|Given PO
15945301|NCT03300544|Drug|Fluorouracil|Given IV
15945302|NCT03300544|Drug|Leucovorin|Given IV
15945303|NCT03300544|Drug|Oxaliplatin|Given IV
15945304|NCT03300544|Radiation|Radiation Therapy|Undergo chemoradiation
15945305|NCT03300544|Biological|Talimogene Laherparepvec|Given intralesionally
15945306|NCT03300531|Biological|Ultrasound-guided pure platelet-rich-plasma (P-PRP) injection|Blood will be drawn, and tendon will be penetrated with dry needle under ultrasound guidance. Pure platelet-rich plasma will be injected into the tendon.Once a week for three times.
15945307|NCT03300531|Biological|Ultrasound-guided platelet-rich-plasma (PRP) injection|Blood will be drawn, and tendon will be penetrated with dry needle under ultrasound guidance. Platelet-rich plasma will be injected into the tendon.Once a week for three times.
15945308|NCT03300531|Drug|Ultrasound-guided Compound betamethasone injection|Tendon will be penetrated with dry needle under ultrasound guidance. Compound betamethasone will be injected into the tendon.Once a week for three times.
15945309|NCT03300518|Drug|Follitropin Beta;MSD|Patients will start stimulation with a daily s.c. injection of follitropin beta( 300IU Puregonon;MSD) menstrual cycle day 2 or 3.
15945310|NCT03300518|Drug|Ganirelix|A daily administration of ganirelix (0.25 mg Orgalutran; MSD) was introduced when the leading follicle is near 13mm, and was repeated up to the time of hCG administration.
15945311|NCT03300518|Drug|hCG|Ovulation was triggered when the leading follicles reach 18-20mm and at least two follicles 17-18mm , HCG 10000 IU is used to trigger
15945312|NCT03300518|Drug|estradiol valerate|Estradiol valerate (progynova,Schering) daily dose of 4 mg (2 mg twice a day) was given orally, started 7 days before the presumed onset of menses and administered up to 2 days of the next menstrual cycle
15945313|NCT03300505|Drug|ARRx|Given intravenously (IV)
15945314|NCT03300505|Drug|Enzalutamide|Given by mouth (PO)
15945315|NCT03300492|Other|NK-DLI|"Application of three infusions of ex vivo expanded NK cells on days
~+10, +15 and +20 with increasing NK cell doses (1x107/kg, 1x108/kg and the remaining cells up to 1x109/kg) following haplo-HSCT. Maximal cumulative T-cell dose is fixed at <1x105/kg."
15945316|NCT03300479|Drug|Clevidipine|Intravenous antihypertensive therapy with Clevidipine for the first 24 hours in patients with nontraumatic intracerebral hemorrhage (ICH).
15945317|NCT03300479|Drug|Urapidil|We compare the therapy with Urapidil to Clevidipine for the acute phase (24 hours) in patients with ICH. We would like to show the efficacy and safety of Clevidipine in this special situation.
15945318|NCT03300466|Device|GP0045|Hyaluronic acid gel
15945319|NCT03300466|Device|Comparator|Hyaluronic acid gel
15945320|NCT03300453|Drug|rAAV2/5-hNAGLU|one-time brain intraparenchymal gene therapy dose
15945321|NCT03300440|Dietary Supplement|Probiotics and vitamin B7|Powder; Sachet to 3 g (3 g = 1 portion) in lyophilized form (7,5 x 109 CFU) Bacteria strains: Bifidobacterium bifidum W23 Bifidobacterium lactis W51 Bifidobacterium lactis W52 Lactobacillus acidophilus W22 Lactobacillus casei W56 Lactobacillus paracasei W20 Lactobacillus plantarum W62 Lactobacillus salivarius W24 Lactococcus lactis W19 125mg D-Biotin (Vitamin B7) 30 mg of Common horsetail 30 mg of Fish collagen 30 mg of Keratin Matrix: corn starch, maltodextrin, inulin, fructooligosaccharides, plant protein, enzymes
15945322|NCT03300440|Dietary Supplement|Placebo and vitamin B7|Powder; Sachet to 3 g (3 g = 1 portion) in lyophilized form 125mg D-Biotin (Vitamin B7) 30 mg of Common horsetail 30 mg of Fish collagen 30 mg of Keratin Matrix: corn starch, maltodextrin, inulin, fructooligosaccharides, plant protein, enzymes
15945323|NCT03300427|Drug|sacubitril/valsatran|sacubitril/valsatran 100 or 200 mg BID
15945324|NCT03300427|Drug|valsartan|Valsartan 80 or 160 mg BID
15945325|NCT03300427|Drug|placebo to valsartan|placebo to valsartan 80 or 160 BID
15945326|NCT03300427|Drug|placebo to sacubitril/valsartan|placebo to sacubitril/valsartan 100 or 200 mg BID
15945327|NCT03300414|Other|One time blood draw|Same as part 1
15945328|NCT03300401|Drug|Perflutren Lipid Microspheres|Receive intravenous injection just prior to ultrasound
15945329|NCT03300401|Drug|Sulfur Hexafluoride Lipid Microspheres|Receive intravenous injection just prior to ultrasound
15945330|NCT03300401|Device|Dynamic Contrast-Enhanced Ultrasound Imaging|Undergo Contrast-Enhanced Ultrasound Imaging
15945331|NCT03300401|Device|Positron Emission Tomography|Undergo PET/CT
15945332|NCT03300401|Device|Computed Tomography|Undergo CT scan
15945333|NCT03300401|Biological|Yttrium-90 (90Y)|Given IV
15945334|NCT03300388|Dietary Supplement|Omega-3 (DHA-rich dietary supplement)|Double-blind randomized placebo-controlled intervention with DHA-rich dietary supplement with or without resistance training program for 16 weeks.
15945335|NCT03300388|Dietary Supplement|Placebo (olive oil)|Double-blind randomized placebo-controlled intervention with DHA-rich dietary supplement with or without resistance training program for 16 weeks.
15945336|NCT03300388|Other|Resistance training|Double-blind randomized placebo-controlled intervention with DHA-rich dietary supplement with or without resistance training program for 16 weeks.
15945337|NCT03300375|Other|Home exercise program|Home-based, progressive exercise program using resistance bands
15945338|NCT03300375|Other|Post Op instructions|Participants will follow all instructions provided to them by their physician and care team, but will be asked to refrain from starting any new strengthening exercise protocols or begin any new physical therapies during this time.
15945339|NCT03300362|Drug|Seasonal influenza vaccine|Seasonal influenza vaccine
15945340|NCT03300362|Drug|MVA-NP+M1|Trial vaccine
15945341|NCT03300362|Drug|Sodium chloride|Saline placebo
15945342|NCT03300349|Other|Fulfillment of a preventive programme|Information about risk factors for breast cancer-related lymphedema and home-based exercise programme for shoulder
15945343|NCT03300349|Other|No fulfillment of a preventive programme|No fulfillment of the preventive programme: Information about risk factors for breast cancer-related lymphedema and home-based exercise programme for shoulder
15945344|NCT03300336|Behavioral|STRIDE|Implementation of STRIDE inpatient hospital mobility program
15945345|NCT03300323|Diagnostic Test|IV fluid challenge administration|Administration of an intravenous fluid challenge to assess for fluid responsiveness
15945346|NCT03300310|Other|nursing visit|nursing visit at patient home
15945347|NCT03300310|Other|no nursing visit|the patient take his treatment without nursing visit
15945348|NCT03300297|Other|Cervical Spine Thrust Joint Manipulation|High velocity, short amplitude thrust to the cervical spine
15945349|NCT03300297|Other|Cervical Spine Sham Manipulation|Manipulative hold position shy of end range without a thrust
15945350|NCT03300297|Other|Home Program|therapeutic exercise program and education
15945351|NCT03300297|Other|Suboccipital Release|suboccipital soft tissue mobilization
15945352|NCT03300284|Behavioral|Questionnaires|Quality of Life Questionnaires
15945353|NCT03300271|Other|Mobile application for self monitoring|Participants in this group will be introduced to use a mobile application to self record and monitor their life style behaviors. They will be also be provided education same as the control group.
15945354|NCT03300271|Other|Education|Participants in this group is provided education. Education includes information of metabolic syndrome, methods to manage lifestyle (diet, physical activity).
15945355|NCT03300271|Other|Mobile application for personal coaching|Participants in this group will be introduced to use a mobile application. Personal coaches such as dietitian, sports manager encourage to improve their life style behaviors. They will be also be provided education same as the control group.
15945356|NCT03300258|Device|Robotic therapy|"The Robotic group will use a robotic training protocol to incentivize recovery of motor control by changing task demands throughout the training period. One or more target tasks will be chosen to mimic different sub-functions of gait, including some which are not normally excited in typical cycling behavior. Also, tasks may be designed to target non-gait motions such as hip ab/adduction. The required task may be changed periodically. This therapy protocol will occupy 30 minutes of each training session. Prior to testing, EMG electrodes will be placed on the major muscles of both legs, a procedure that takes roughly 15 minutes. Another 15 minutes is for changing clothes, briefing the subject, and other ancillary study activities. The total time per training session is 1 hour."
15945357|NCT03300258|Device|Aerobic therapy|The Control group protocol is identical to that of the Robotic group, except the robotically-incentivized exercise is replaced with an aerobic exercise. This intervention emulates a commercial motorized exercise bike to improve cardiovascular unfitness contributions to gait impairment. This therapy implements assist-as-needed and constant-velocity control. The patient's target pedaling speed (e.g. 20 rev/min (to be finalized through pilot tests) and power level (set by heart rate to require approximately 50-70% of maximal oxygen uptake) are set at the beginning of each session and a motor provides assistance or resistance to compensate for the performance of the patient. The exercise will be performed in this mode for 30 minutes per training session.
15945358|NCT03300245|Radiation|Maxillofacial CT|clinical and maxillofacial CT data will be tabulated and analysed using by computer software e.g. Statistical Package for the Social Sciences (SPSS)
15945359|NCT03300232|Behavioral|Computer-based VC-CBT|Computer-based VC-CBT: Six, one-hour computerized therapy sessions delivered on an interactive computerized platform with two-session therapy blocks dedicated to each of three primary modules/goals: 1) psycho-education, 2) skills learning, and 3) individualized practice
15945360|NCT03300219|Behavioral|Cognitive Orientation to Occupational Performance|CO-OP is a top-down, task-oriented, client-centered approach that uses an iterative process of dynamic performance analysis and guided discovery to enable individuals to identify strategies that will improve performance
15945361|NCT03300206|Device|Breast Biopsy|A breast biopsy is a test that removes tissue or sometimes fluid from the suspicious area. The removed cells are examined under a microscope and further tested to check for the presence of breast cancer. A biopsy is a diagnostic procedure that can definitely determine if the suspicious area is cancerous.
15945362|NCT03300180|Behavioral|Collaborative Dementia Care Program|Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.
15945363|NCT03300180|Other|Screening Only|The patients in this group will receive screening for AD coupled with letters sent to the dyads and the primary care PCP informing them of the results of the screening
15945364|NCT03300167|Device|The Liquid Biopsy System|The Liquid Biopsy System is a single use percutaneously-delivered coronary blood sampling device designed to collect blood samples from within a target coronary artery so that the blood can be analysed.
15945426|NCT03299634|Other|printed questionnaire|For each eligible participant, a full history will be obtained according to a questionnaire followed by thorough clinical examination.
15945598|NCT03298308|Device|Cranial Electric Stimulation|Micro amperage TCDS
15945365|NCT03300154|Behavioral|Financial incentives|The study nurses will schedule an appointment with the doctor at the health center, within 4 weeks from the participant's inclusion in the study. Participants who attend the first visit at the health center will receive a direct incentive consisting of the payment of a limited amount to be determined (approximately AR $ 150-200) through a shopping voucher for the amount mentioned. Participants attending the follow-up visit at the health center within 3 months from their inclusion in the study will participate in a lottery. The lottery will offer the possibility of winning a new voucher with a probability of 1 in 3. Participants who do not attend the health center will not receive any incentive.
15945366|NCT03300154|Behavioral|Framing (SMS)|After inclusion, participants will receive weekly text messages (SMS) using a specific framing or formulation of the message, highlighting the potential benefits and positive aspects of health care. These messages will promote follow-up visits, adherence to treatment, and benefits to be gained from a follow-up visit with the physician. Messages will be sent with a frequency of two per week during the first 30 days and then 1 per week until the end of the follow-up. These messages will have no cost to participants.
15945367|NCT03300141|Other|Veridical Visual Feedback|Reaching while sitting at the Looking Glass system. The representation of arm movements will directly reflect the participants actual arm movements.
15945368|NCT03300141|Other|Augmented Visual Feedback|Reaching while sitting at the Looking Glass system. The representation of a participant's arm movements will be augmented to encourage different movement patterns and improved movement.
15945369|NCT03300141|Other|Healthy Comparative Reaching Task|Reaching while sitting at the Looking Glass system. This will occur over the course of 1 hour.
15945370|NCT03300128|Behavioral|Incredible Years - ASD|The IY-ASD intervention is designed for parents of children with autism spectrum disorder. The programs uses a mix of videos, collaborative brainstorming sessions, and role plays to deliver content on child-directed play and positive discipline practices.
15945371|NCT03300128|Other|Circle of Parents|"Circle of Parents is an open parent support group led by a parent leader. Participants are encouraged to share resources and other support both during groups, and between meetings."
15945372|NCT03300115|Drug|AC0010|After subjects prove eligible after screening and are enrolled, they are given AC0010 300 mg Bid (the two doses are advised to be administered at an interval of 12 hours), receive evaluation of safety indicators every 3 weeks, efficacy evaluation every 6 weeks until disease progression or intolerable toxicities or withdrawal from the trial. (If the investigator suspects disease progression, CT or MRI may be performed in advance; if the patient does not have disease progression, subsequent efficacy evaluation will proceed still according to the protocol).
15945373|NCT03300102|Other|Questionnaires, interviews and or tissue donation|Subjects will be asked to complete either structured questionnaires, semi-structured interviews or donate tissue. There will be some overlap, but each subject does not have to do all three interventions.
15945374|NCT03300089|Procedure|General anaesthesia|General anaesthesia
15945375|NCT03300089|Procedure|Regional anaesthesia|Regional anaesthesia
15945376|NCT03300063|Other|Low flow nocturnal oxygen|Nocturnal low-flow oxygen via nasal cannula
15945377|NCT03300050|Biological|cH8/1N1 LAIV|"Live-attenuated influenza virus vaccine (LAIV) expressing chimeric hemagglutinin (HA) with the H8 head and H1 stalk and neuraminidase (NA) subtype 1 (N1) (cH8/1N1):
~HA head, A/mallard/Sweden/24/2002 (H8N4); HA stalk, A/California/04/2009 (H1N1); NA, A/California/04/2009 (H1N1) containing the backbone of the cold-adapted/temperature sensitive of the Russian LAIV A/Leningrad/134/17/1957 (Len17 IDCDCRG46D).
~Administered intranasally as drops at a dose of 10⁷·⁵ (plus or minus ⁰·⁵) 50% egg infectious dose (EID50), formulated in a total volume of 0.5 mL sterile saline (0.25 mL per nostril)."
15945378|NCT03300050|Biological|AS03-adjuvanted cH5/1N1 IIV|"Chimeric H5 head with H1 stalk plus N1 (cH5/1N1) split virion inactivated influenza virus vaccine (IIV) plus AS03 adjuvant: HA head, A/Vietnam/1203/2004 (H5N1); HA stalk, A/California/04/2009 (H1N1); NA, A/California/04/2009 (H1N1).
~Administered intramuscularly at a dose of 15 μg of hemagglutinin in a volume of 0.5 mL of phosphate buffered saline (PBS)."
15945379|NCT03300050|Biological|cH5/1N1 IIV|"Chimeric H5 head with H1 stalk plus N1 (cH5/1N1) split virion inactivated influenza virus vaccine (IIV):
~HA head, A/Vietnam/1203/2004 (H5N1); HA stalk, A/California/04/2009 (H1N1); NA, A/California/04/2009 (H1N1).
~Administered intramuscularly at a dose of 15 μg of hemagglutinin in a volume of 0.5 mL of phosphate buffered saline (PBS)."
15945380|NCT03300050|Biological|AS03-adjuvanted cH8/1N1 IIV|"Chimeric H8 head with H1 stalk plus N1 (cH8/1N1) inactivated influenza vaccine plus AS03 adjuvant: HA head, A/mallard/Sweden/24/2002 (H8N4); HA stalk, A/California/04/2009 (H1N1); NA, A/California/04/2009 (H1N1).
~Administered intramuscularly at a dose of 15 μg of hemagglutinin in a volume of 0.5 mL of phosphate buffered saline (PBS)."
15945381|NCT03300050|Biological|Normal saline|Administered intranasally as 0.25 mL nasal drops per nostril
15945382|NCT03300050|Biological|Phosphate buffered saline (PBS)|Administered intramuscularly as 0.5 mL injection
15945383|NCT03300037|Device|Kinesthetic stimulation|The kinesthetic actuator is placed on the skin near the ear and emits vibrations.
15945384|NCT03300024|Device|Expanded polytetrafluoroethylene Graft|Group will receive any standard ePTFE graft (control) based on the surgeons' discretion. The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.
15945385|NCT03300024|Device|Bovine Carotid Artery Graft|Group will receive the BCA graft (experimental).The graft will be placed either in the arm (brachial artery to axillary vein) or forearm (brachial artery to cephalic or suitably sized vein) depending on which location works best in your particular case.
15945386|NCT03300011|Device|stent|PTCA or PCI
15945387|NCT03299998|Procedure|Maxillary and mandibular blocks|A Pajunk SonoPlex Stim needle 22G x 55 mm was used. For maxillary nerve block, needle was introduced next to the angle of the orbitae and the zygomatic ridge. The needle was sank until coming into contact of the temporal bone. It was then orientated to the controlateral nostril and sank of 1 cm. For mandibular block, needle was introduced in the pterygoid fossa under and perpendicularly to the zygomatic arch, and sank until the pterygoid process. The needle was then orientated towards controlateral orbitae and sank with neurostimulation. After a motor response at 0.6 milliampere (mA) and the disappearance of contraction at 0.3 mA, local mixture was injected. The mixing of local anesthesia was made of ropivacaine 5 mg/mL and clonidine 30 µg. Five mL were injected in every block for a total of 20 mL.
15945680|NCT03297671|Drug|RhIg prophylaxis|Two RhIg prophylaxis injections for Rh negative women
15945388|NCT03299998|Procedure|General anesthesia|Anesthesia was standardized and provided using intravenous administration of propofol and remifentanil. Patients were mechanically ventilated with a mixture of air (50/50), and desflurane or sevoflurane, or Target-controlled infusion (TCI) propofol. One to 5 mg/kg of methyl-prednisolone were administered to reduce inflammatory response.
15945389|NCT03299985|Other|Diaphragmatic myofascial release|Subjects in this arm will receive different myofascial release techniques aimed to normalize the myofascial tension of the diaphragmatic muscle
15945390|NCT03299985|Other|Sham myofascial release|Subjects in this arm will receive the same manual techniques of the diaphragmatic myofascial release group, but without the myofascial stimulus
15945391|NCT03299972|Dietary Supplement|Whey Protein|25 g whey protein supplementation twice daily (breakfast and lunch)
15945392|NCT03299972|Dietary Supplement|Control|23.75 g maltodextrin twice daily (breakfast and lunch)
15945393|NCT03299972|Other|Resistance Exercise|60 minutes of resistance exercise twice a week
15945394|NCT03299959|Device|Agili-C implant|Agili-C implant
15945395|NCT03299959|Procedure|SSOC|microfracture and/or debridement
15945396|NCT03299946|Drug|Cabozantinib|Cabozantinib (40mg) will be taken by mouth daily for 8 weeks.
15945397|NCT03299946|Drug|Nivolumab|Nivolumab 240mg intravenously every 2 weeks (days 14, 28, 42, and 56 for a total of four doses), in combination with Cabozantinib 40mg by mouth daily for 8 weeks.
15945398|NCT03299920|Other|Standardized instructions|Specific instructions related to peripheral nerve block.
15945399|NCT03299920|Other|Conventional instructions|Usual post-operative instructions.
15945400|NCT03299907|Diagnostic Test|Spirometry|
15945401|NCT03299894|Procedure|systematic calculation of qSOFA|calculation of qSOFA for each patient
15945402|NCT03299881|Device|Transcutaneous Nerve Stimulator (TENS)|The Elira wearable patch system is a RF coupled, wearable transcutaneous electrical nerve stimulator (TENS) device controlled via Bluetooth by a smart phone unit running a custom application which directs therapy from the patch within safe limits set by a clinician and also includes a weight loss diary.
15945403|NCT03299881|Behavioral|Diet & Exercise|Subjects to be instructed on a healthy 1200 calorie diet.
15945404|NCT03299868|Device|peripherally inserted central catheter (PICC)|comparisons of the safety, efficacy, and patient-perceived satisfaction between the initially routine PICC insertion group (routine PICC group) and general IV access group (general IV group)
15945405|NCT03299855|Other|Passation of neuropsychological test|Passation of MoCA and MMS tests associated with neuropsychological test
15945406|NCT03299842|Drug|ZX008 (Fenfluramine Hydrochloride)|ZX008 is supplied as an oral solution in a concentration of 2.5 mg/mL. Subjects will be titrated to an effective dose beginning with 0.2 mg/kg/day (maximum: 30 mg/day).
15945407|NCT03299829|Drug|Trientine|Trientine is a chelating agent for removing the copper from the body
15945408|NCT03299816|Behavioral|Coaching DASH group (C-DASH)|Participants assigned to the C-DASH diet advice group will be provided $30/week worth of fruits, vegetables, nuts and beans ordered through the study coach and delivered to a community location to reach a certain goal of potassium intake (months 0-4). During phase 2 of the study (months 5-12), a study coach will continue telephonic contact with the participants to set goals for following a DASH-like diet without the weekly food allowance.
15945409|NCT03299816|Behavioral|Self-Shopping DASH group (S-DASH)|Participants will be given a brochure containing information about the DASH diet which will be reviewed with a study team member. In months 1-4, participants will receive a gift card equivalent to a weekly allowance of $30 to Klein's ShopRite stores of Maryland for purchases of food and beverages of their choice. During phase two (months 5-12), they will be asked to continue following a DASH-like diet but will not receive a gift card for purchases.
15945410|NCT03299803|Behavioral|Men's Healing Pathways|Peer implemented group self management program to reduce depressive symptoms in men with physical disabilities
15945411|NCT03299790|Other|high-intensity interval exercise training (HIIT)|This program includes 24 weeks of exercise training and is divided in different phases (phase 1: week 1-2, equal to the MIT group, phase 2: week 3-6, 6 bouts of high-intensity exercise, phase 3: week 7-12, 7 bouts of high-intensity exercise, phase 4: week 13-24, 8 bouts of high-intensity exercise). The exercise training program consists of 3 exercise sessions per week (for 6 months).
15945412|NCT03299790|Other|moderate-intensity exercise training (MIT)|This program includes 24 weeks of exercise training and is not devided in phases. The exercise training program consists of 3 endurance exercise sessions per week (for 6 months). The total exercise volume equals the exercise volume of the HIIT group.
15945413|NCT03299764|Device|Pursed lip breathing ventilation|A non-invasive ventilation device mimicking the pursed lip breathing in COPD patients will be used.
15945414|NCT03299764|Device|Standard non-invasive ventilation|Standard non-invasive ventilation
15945415|NCT03299751|Biological|Diagnostic performances of biomarkers combination|"A blood sample of 400µL will be drawn at inclusion, when neonatal sepsis is suspected, at the same time of a venipuncture prescribed for standard care.
~The dosage of 11 biomarkers will be performed in a central laboratory."
15945416|NCT03299738|Biological|C-CAR011|Autologous 2nd generation CD19-directed CAR-T cells, single infusion intravenously at a target dose of 0.5-5.0 x 10^6 anti-CD19 CAR+ T cells/kg
15945417|NCT03299725|Drug|colloidal bismuth sub-citrate|colloidal bismuth sub-citrate administered as an adjunctive therapy in combination with esomeprazole, amoxicillin and metronidazole
15945418|NCT03299712|Device|ArteFill|soft tissue filler
15945419|NCT03299686|Drug|CJM112|300 mg CJM112 (Study treatment) s.c. injection received per week for the first 4 weeks, followed by once every two weeks up to Week 12 (Day 85) + standard of care treatment.
15945420|NCT03299686|Other|Placebo to CJM112|Placebo to match CJM112 + standard of care treatment
15945421|NCT03299660|Drug|Avelumab|Avelumab 10 mg/Kg every 2 weeks for 4 cycles post LCCRT
15945422|NCT03299660|Drug|5 Fluorouracil|5FU continuous infusion 225mg/m2/day during radiotherapy
15945423|NCT03299660|Drug|Capecitabine Pill|Can be administered in place of 5FU infusion. Dose = 825 mg/m2 twice a day on each day of radiotherapy
15945424|NCT03299660|Radiation|Radiotherapy|50.4 Gy in 28 fractions delivered over 5.5 weeks as 5 fractions/week
15945425|NCT03299660|Procedure|Surgical Resection|Surgical resection of tumour mass post radiotherapy and chemotherapy
15945681|NCT03297671|Device|ELDONCARD|ELDONCARD point-of-care test.
15945428|NCT03299621|Drug|Muscle Relaxant|Monitoring of PLE value using the monitoring of PLEM™ device before and after the injection of muscle relaxant that used for tracheal intubation.
15945429|NCT03299608|Diagnostic Test|Breath analysis|Spectrometric analysis of exhaled breath as screening for opportunistic respiratory infections
15945430|NCT03299595|Other|printed questionnaire|For each eligible participant, a full history will be obtained according to a questionnaire followed by thorough clinical examination.
15945431|NCT03299582|Device|Hypothermia|Healthy subjects will undergo 3 hours of hypothermia at various temperature levels.Cancer subjects will undergo 4 hours of hypothermia during every cycle of chemotherapy.
15945432|NCT03299582|Device|Cryocompression|Healthy subjects will undergo 3 hours of cryocompression. Cancer subjects will undergo a minimum duration of 2 hours and a maximum duration of up to 4 hours of cryocompression during every cycle of chemotherapy.
15945433|NCT03299556|Other|WHT|Incorporating WHT into treatment for chronic pain. WHT includes patient and provider tracking of patient-reported pain, pain management, medication usage, functionality, depression, activity and sleep (measured by 3 axis actigraph); as well as prompts to subjects to engage in self-care, including non-pharmaceutical pain management therapies consistent with MPP training.
15945434|NCT03299543|Device|LEVL (Medamonitor)|Subjects will provide duplicate breath samples to the LEVL device for analysis of breath acetone
15945435|NCT03299530|Other|patients with corneal astigmatism|The total corneal astigmatism, anterior chamber depth, will be measured by a Scheimpflug tomographer. Pupil size will be measured by itrace device and MONCV3 device. Residual astigmatism will be tested by subjective refraction.
15945436|NCT03299517|Drug|Antiarrythmic Drugs|Patient will be randomly randomized 1: 1 for the antiarrythmic drugs. If there is no reversal and there is no adverse event, a further dose of the same pre-administered medicinal product will be performed in another 30 minutes.
15945437|NCT03299517|Drug|Antiarrhythmic drugs|Patient will be randomly randomized 1: 1 for the the antiarrythmic drugs. If there is no reversal and there is no adverse event, a further dose of the same pre-administered medicinal product will be performed in another 30 minutes.
15945438|NCT03299504|Other|Exercise|5 days per week, 2.5 hours per day strength, balance and endurance training on an outpatient basis
15945439|NCT03299491|Other|MWA intervention|The MWA intervention will involve upgrading existing maternity waiting areas to ensure that essential supplies and services are available to create a comfortable environment for women to temporarily reside in and have easy access to skilled obstetric services.
15945440|NCT03299491|Other|IEC intervention|"Community and religious leaders will each attend one-day workshops designed using participatory, adult learning methods to help participants better understand the importance of maternal health care services, identify barriers to accessing care and to strategize how to promote utilization of services. Half-day workshops will conducted in subsequent years to build on shared experiences.
~Health extension workers will attend 3-day workshops to identify enablers and barriers to implementation of the safe motherhood components of the health extension program and strategize on how to engage community and religious leaders to support access to maternal health care services in their communities.
~Half-day workshops will conducted in subsequent years for each of the participant groups to build on shared experiences."
15945441|NCT03299478|Other|Will look for immune infiltration|
15945442|NCT03299465|Behavioral|Yoga|This is a single arm study and all participants will be assigned to a six-week restorative yoga intervention. Restorative yoga sessions will consist of gentle physical poses (asanas), breathing control (pranayama), and relaxation (savasana).
15945443|NCT03299452|Drug|Non Chemotherapy|Drugs screened by the Alphacait screening system will be administered in accordance with the protocol of the drug specification or the CPSC guidelines.
15945444|NCT03299452|Drug|Chemotherapy and target therapy|Drugs screened by the Alphacait screening system will be administered in accordance with the protocol of the drug specification or the CPSC guidelines.
15945445|NCT03299452|Drug|Chinese herb medicine|Drugs screened by the Alphacait screening system will be administered in accordance with the protocol of the drug specification or the CPSC guidelines.
15945446|NCT03299439|Other|acupuncture|a stimulation of the body or auricular points
15945447|NCT03299426|Biological|Vi-Typhoid Conjugate Vaccine (Vi-TCV)|Single 0.5-ml intramuscular injection
15945448|NCT03299426|Biological|Meningococcal A Conjugate Vaccine (MCV-A)|Single intramuscular injection. Children 9-11 months will receive a 5µg/0.5ml dose. Children 12 months and older will receive a 10µg/0.5 ml dose.
15945449|NCT03299413|Biological|Wharton Jelly Mesenchymal stem cells|Wharton Jelly Mesenchymal stem cells will be injected intravenously
15945450|NCT03299400|Device|Contact lens sensor|Patient will continue to wear the contact lens postoperatively for a total of 24 hours or until the patient cannot tolerate the contact lens. After removal of the contact lens sensor, the recorded profiles will be collected and visualized graphically on a computer interface.
15945451|NCT03299387|Drug|Nitrofurantoin|Participants will receive oral Nitrofurantoin 100 mg twice daily for 7 days
15945452|NCT03299387|Drug|Gentamicin|Participants will receive intravesical via catheter Gentamicin solution 25 mg in 50cc for 3 days
15945453|NCT03299374|Other|Pilates Intervention|Intervention based on Pilates principles
15945454|NCT03299374|Other|Fall prevention intervention|Intervention based on principles to prevent falls
15945455|NCT03299361|Other|Magnetic resonance image (MRI)|Diffusion tensor magnetic resonance imaging (DTI) of MRI reveals tissue microstructure based on random movements of water molecules. Here we monitored, by means of DTI, median nerve integrity in CTS patients before and after corticosteroid injection. This information may help to explain the hypothesis regarding the effect of corticosteroid to the median nerve, to identify which anatomic location of median nerve relevant to the symptom relief of CTS after corticosteroid injection, and be useful for the clinical follow-up of patients with nerve entrapments following conservative treatment.
15945456|NCT03299348|Behavioral|AgingPLUS|The program consists of 2-hour meetings for a total of 4 weeks (total of 8 hours) and discusses (a) how negative views on aging and negative age stereotypes undermine adults' health-promoting behaviors; (b) how adults can take control of their own aging; and (c) how personal goals can be achieved through more effective goal planning and action plans.
15945491|NCT03299101|Other|Prehabilitation|Prehabilitation will last 4 weeks and consist of a novel, home-based regimen of (a) aerobic conditioning; (b) strength and coordination training; (c) respiratory muscle training; and (d) nutritional coaching and supplementation.
15945457|NCT03299348|Behavioral|Active Control Group|The program consists of 2-hour meetings for a total of 4 weeks (total of 8 hours) and discusses (a) four major health conditions that affect the lives of many middle-aged and older adults (e.g., cardiovascular disease, cancer, type 2 diabetes; clinical depression); and (b) how these conditions can be managed successfully.
15945458|NCT03299335|Other|Blood collection|assay of CPK and anti-cN-1A antibodies
15945459|NCT03299322|Drug|Jia Wei Yang He granule|This is an empirical traditional Chinese medicine compound used in the treatment of asthma for a long time
15945460|NCT03299322|Drug|Jia Wei Yang He granule Placebo|Made from 1/20 doses which has certain taste, but no therapeutic effect
15945461|NCT03299309|Drug|PEP-CMV|Patients receive temozolomide (TMZ) 200 mg/m2/day x 5 days. On day 20, patients will receive a Tetanus-diphtheria pre-conditioning vaccination with Td (tetanus, diphtheria toxoid, adsorbed). Immunotherapy begins the following day, on day 21, with injection of the PEP-CMV vaccine as follows: PEP-CMV Component A mixed with Montanide ISA-51 intradermally administered half in the RIGHT groin and half in the LEFT groin.
15945462|NCT03299296|Drug|Rivaroxaban 10 Milligrams|The first group is to be on Rivaroxaban 10 mg with dosage according to the orthopedic approved regimen (10 mg once daily 6-10 hours after the surgery; recommended total duration of therapy: 12 to 14 days; The American College of Chest Physicians (ACCP) recommendation: Minimum of 10 to 14 days; extended duration of up to 35 days suggested.
15945463|NCT03299296|Drug|Enoxaparin 40 Milligrams/0.4 Milliliters Prefilled Syringe|"The other group will be administered the standard of care (SOC) enoxaparin as follows:
~Once-daily dosing: 40 mg once daily, with initial dose within 9 to 15 hours before surgery, and daily for at least 10 days (or up to 35 days postoperatively) or until risk of deep venous thrombosis (DVT) has diminished or the patient is adequately anticoagulated on warfarin. The American College of Chest Physicians recommends initiation ≥12 hours preoperatively or ≥12 hours postoperatively; extended duration of up to 35 days suggested."
15945464|NCT03299283|Diagnostic Test|BioFire test platform|Analysis of analyte stability under various conditions as measured by BioFire test platforms
15945465|NCT03299270|Other|Questionnaires|Quality of Life and Functional recovery questionnaires
15945466|NCT03299257|Drug|donepezil treatment|30-day donepezil treatment
15945467|NCT03299244|Drug|Etelcalcetide|Administered intravenously three times per week.
15945468|NCT03299244|Drug|Cinacalcet|Cinacalcet administered orally once a day.
15945469|NCT03299231|Device|OPEP Aerobika|Previous studies of OPEP device shows preliminary benefit in subjects with COPD. No serious adverse events were recorded in previous studies. The device is FDA registered.
15945470|NCT03299231|Device|OPEP Aerobika Sham device|The same OPEP device which is devoid of the nebulizer port valve to render it inactive. Used for control sham arm.
15945471|NCT03299218|Dietary Supplement|SNF (Wawamum)|A monthly ration of 30 sachets of SNF (one 50 gram sachet of Wawamum per child per day) will be provided by LHWs. Each recruited child will receive SNF on a monthly basis for the duration of 18 months during his/her age of 6-24 months.
15945472|NCT03299218|Behavioral|Social and behaviour change communication (SBCC)|SBCC messages will be delivered by LHWs in their monthly routine household visits. Male and female group sessions will be arranged on quarterly basis with the help of health committees.
15945473|NCT03299218|Other|Cash|Cash totaling 1600 rupees per month will be transferred by BISP throughout the study period.
15945474|NCT03299205|Behavioral|Exercise|The exercise intervention consists of moderate intensity aerobic exercise intervention that will include the wearing of an accelerometer (i.e. Fitbit Zip) to monitor daily activity and steps. Aerobic exercise will be conducted over 10-weeks in PLWHA +/- AUD. The programs will consist of aerobic exercise 3 days per week of moderate intensity for 30-45 minutes each session with the goal of achieving 135 minutes per week. The program will begin at low-moderate intensity and progress to higher intensity exercise after week 4 of the program. All exercise will be completed on a treadmill and supervised by study staff. Each participant will be provided with a Fitbit Zip to monitor daily activity and steps with a goal of 7000 steps per day.
15945475|NCT03299192|Behavioral|Tai Chi|Yang Style Tai Chi
15945476|NCT03299192|Behavioral|Health Education|Comprehensive Health Education relevant for Healthy Aging in Patients with Chronic Back Pain
15945477|NCT03299192|Other|Usual Medical Care|Medications, PT, Complementary and Integrative Health and other miscellaneous treatments as appropriate.
15945478|NCT03299179|Device|MRI scan|Several MRI scan modalities: MPRAGE (structural scan), arterial spin labeling (cerebral perfusion), resting state functional-MRI (fMRI, cerebral activity) and diffusion MRI (white matter diffusion and white matter tracts).
15945479|NCT03299179|Device|Physiological monitoring|During MRI: heart rate, end-tidal carbon dioxide (CO2), respiratory rate and skin conductance
15945480|NCT03299179|Biological|Blood sample|Blood sample after MRI-session: measurement of hematocrit, hemoglobin, estradiol, progesterone, follicle stimulation hormone and luteinizing hormone.
15945481|NCT03299179|Device|Blood pressure measurement|Measuring blood pressure before and after MRI-scan
15945482|NCT03299179|Device|Body temperature|Measuring body temperature before and after MRI-scan
15945483|NCT03299179|Other|Questionnaires|Questionnaires at the start of the study on lifestyle. Additionally, a questionnaire before each scan session on the actual state of the volunteer (e.g. mood, caffeine consumption, alcohol, medication, etc.)
15945484|NCT03299179|Diagnostic Test|Pregnancy test|Test for pregnancy using a pregnancy dipstick test
15945485|NCT03299166|Drug|BHV-4157|BHV-4157, 140mg capsule QD
15945486|NCT03299166|Drug|Placebo|matching capsule QD
15945487|NCT03299153|Other|barberry juice|
15945488|NCT03299140|Behavioral|Family Focused Therapy|
15945489|NCT03299127|Behavioral|imagery rescripting|"The long version of the manual contained 4,959 words, the brief version had 3,369 words. Individuals were encouraged patients to time travel to negative personal events, enter the scene and protect or comfort their younger-ego. The participant should bring the negative event to a happy end. This could also be a fictive, compassionate person and may violate the laws of physics (e.g., a person may fly). Readers were encouraged to embellish the scenes as much as possible so that it competed with the original scene. This technique was then applied to future events. For the last technique, patients were asked to seek a corresponding mood-congruent metaphor, creature or symbol; for example, a small bird that has fallen out of its nest. Using their mind's eye, these images may be transformed into something of beauty or pride."
15945490|NCT03299114|Other|Whirlpool|
15945494|NCT03299062|Diagnostic Test|Cytology and Immunohistochemistry|Determine if nasal swabs can provide an adequate sample for evaluation using cytology and immunohistochemistry for alpha-synuclein, A-beta and p-tau staining.
15945495|NCT03299049|Drug|Cabotegravir Tablets|CAB tablets are white to almost white oval shaped film coated 30 mg tablets for oral administration. CAB tablets are to be stored up to 30 degree Celsius and protected from moisture.
15945496|NCT03299049|Drug|Rilpivirine Tablets|"RPV tablets are 25 mg tablets that are off-white, round, biconvex, film-coated and debossed on one side with TMC and the other side with 25. RPV tablets should be stored at 25 degree Celsius (excursions permitted to 15 degree-30 degree Celsius) and protected from light."
15945497|NCT03299049|Drug|Cabotegravir Injectable Suspension|CAB LA injectable suspension is a sterile white to slightly pink suspension containing 200 mg/mL of GSK1265744 as free acid for administration by IM injection. CAB LA injectable suspension is to be stored at up to 30 degree Celsius and should not be freezed.
15945498|NCT03299049|Drug|Rilpivirine Injectable Suspension|RPV LA injectable suspension is a sterile white suspension containing 300 mg/mL of RPV as the free base for administration by IM injection. RPV LA injectable suspension should be kept in the outer package and stored at 2-8 degree Celsius and should not be freezed. RPV LA should also be protected from light.
15945499|NCT03299036|Device|Taiwan ACE Beads with doxorubicin|Similar with commercializing drug-eluting beads, radiologist inject Taiwan ACE Beads with doxorubicin instead of Gelfoam or polyvinyl alcohol.
15945500|NCT03299023|Other|Medibyte Portable Monitor|Patients will be provided with the portable monitor in order to measure their apnea/hypopnea index.
15945501|NCT03298997|Procedure|Ligation and Hemorrhoidopexy|"Identification through palpation and ligation of the hemorrhoidal nodules (3rd, 7th, 11th hour), using an absorbable polyglycolic acid suture (2-0, 5/8 inch needle).
~Prior to operation, the patients will be submitted to pudendal nerve block."
15945502|NCT03298997|Procedure|Ultrasound Guided Ligation of Hemorrhoidal Arteries|"Ultrasound guided identification and ligation of the hemorrhoidal arteries, using an absorbable polyglycolic acid suture (2-0, 5/8 inch needle).
~Prior to operation, the patients will be submitted to spinal anesthesia."
15945503|NCT03298984|Drug|Alvocidib|IV bolus followed by IV infusion
15945504|NCT03298984|Drug|Cytarabine|continuous infusion
15945505|NCT03298984|Drug|Daunorubicin|IV bolus
15945506|NCT03298971|Other|Questionnaires|Participants were asked to respond to the questionnaires including Hong Kong Chinese Version World Health Organization quality of life measure, abbreviated version (WHOQOL-BREF (HK)), the Chinese version of The Center for Epidemiological Studies - Depression Scale (CES-D), the Chinese version of Rosenberg self-esteem scale, and the Chinese version of the Herth Hope Index (HHI).
15945507|NCT03298958|Drug|Rapamycin|Subject will be randomized to one of the 2 arms
15945508|NCT03298958|Drug|Placebo Oral Tablet|Subject will be randomized to one of the 2 arms
15945511|NCT03298932|Procedure|Aortic valve surgery|Aortic valve surgery
15945512|NCT03298919|Behavioral|Exercise Video Games|12 weeks laboratory based exercise videogames
15945513|NCT03298919|Behavioral|Aerobic Exercise|Stationary bike and/or treadmill walking for 12 weeks
15945514|NCT03298919|Behavioral|Home exercise videogames|videogame console and active videogames
15945515|NCT03298919|Behavioral|Home Standard Exercise|Personalized physical activity promotion materials
15945516|NCT03298906|Drug|Esketamine|Participants will self-administer one intranasal spray of 14 mg esketamine at Time 0 and again 5 minutes later on Day 1, a total dose of 56 mg in Treatment Period 1 and 2.
15945517|NCT03298906|Drug|Ticlopidine|Participants will receive 250 mg ticlopidine tablets orally twice daily on Day -9 through Day 1 in Treatment Period 2.
15945518|NCT03298893|Drug|Nivolumab Injection|2 possible doses : flat dose 240 mg q2 weeks or 1mg/kg q2 weeks
15945519|NCT03298893|Drug|Cisplatin|40 mg/m2, once a week during radiotherapy
15945520|NCT03298893|Radiation|radiotherapy|"Intensity-modulated radiation therapy (including volumetric-modulated arc therapy and tomography) will be used. A dose of 45 Gy will be delivered to the pelvis in 25 fractions of 1.8 Gy using a 6-MV photon energy.
~An additional dose of 54 Gy in 25 fractions of 2.16 Gy may be delivered to invaded lymph nodes using SIB-IMRT.
~An additional lateral pelvic dose may be delivered if coverage of the target volumes is judged insufficient. The volumes, doses and techniques will be those usually used in each center."
15945521|NCT03298880|Device|Supine VM VAD|Valsalva strain delivered using VAD
15945522|NCT03298880|Device|Supine VAD manometer|supine Valsalva strain delivered using manometer
15945523|NCT03298880|Other|Modified VM VAD|modified VM using VAD
15945524|NCT03298880|Other|Modified VM Manonmeter|Postural modified position VM using manometer
15945525|NCT03298867|Biological|Teprotumumab|Teprotumumab is a fully human anti-IGF-1R mAb. Teprotumumab will be provided in single-dose 20 mL glass vials as a freeze-dried powder. Each vial of teprotumumab must be reconstituted with 10 mL of water for injection. Reconstituted teprotumumab solution must be further diluted in 0.9% (w/v) sodium chloride (NaCl) solution prior to administration. Teprotumumab will be administered in 100 mL or 250 mL infusion bags (100 mL infusion bags for doses up to 1800 mg and 250 mL infusion bags for doses > 1800 mg).
15945526|NCT03298867|Other|Placebo|Placebo will consist of normal saline (0.9% NaCl) solution and will be administered in 100 mL or 250 mL infusion bags, as would be appropriate, per weight-based dosing volumes (100 mL infusion bags for doses up to 1800 mg and 250 mL infusion bags for doses > 1800 mg).
15945527|NCT03298854|Device|99mTc-MDP SPECT/CT|Delayed whole body images, using Symbia-T-Siemens dual headed gamma camera, will be obtained 2-3 hours after injection of 15-25 mCi of Tc-99m MDP (Methylene diphosphonate) followed by SPECT images of the lumbar spine and pelvis.
15945528|NCT03298841|Device|Zeiss|"This study proposal will highlight the advanced technology features of the Zeiss Lumera surgical operating microscope which include but are not limited to:
~Stereo Coaxial Illumination for improved visualization High resolution video screen/co-observation tool to help OR staff anticipate next steps Integrated toric alignment tool Surgical microscope touch screen Cordless foot control for faster turnover between cases"
15945682|NCT03297671|Diagnostic Test|ELDONCARD Test|LHVs will perform ELDONCARD test.
15946322|NCT03292653|Drug|Sotagliflozin|Pharmaceutical form: Tablet; Route of administration: Oral
15945529|NCT03298828|Biological|CD19 CAR and PD-1 knock out engineered T-cells|A single dose of 1 x 10^6/kg CD19 CAR transduced and PD-1 knock out engineered T-cells will be given as an intravenous injection through a Hickman line or PICC line(peripherally inserted central catheter) on day 0.
15945530|NCT03298828|Biological|CD19 CAR T-cells|A single dose of 1 x 10^6/kg CD19 CAR transduced T-cells will be given as an intravenous injection through a Hickman line or PICC line(peripherally inserted central catheter) on day 0.
15945531|NCT03298815|Biological|Amniotic Fluid Eye Drops (AFED)|One drop (0.25 mL) in one eye twice daily for up to 3 months
15945532|NCT03298815|Other|Saline Solution|One drop (0.25 mL) in the other eye twice daily for up to 3 months
15945533|NCT03298802|Drug|Hydrochlorothiazide 50mg Tablet|Hydrochlorothiazide 50 mg per os once daily as soon as the subjects can tolerate sips of water after delivery and for a total of fourteen days postpartum.
15945534|NCT03298802|Drug|Placebo Tablet|Placebo per os once daily as soon as the subjects can tolerate sips of water after delivery and for a total of fourteen days postpartum
15945535|NCT03298789|Other|Activation exercise|Two series of 4 activation exercise will be included in the intervention.
15945536|NCT03298789|Other|7 series of static stretching|7 series of 4 20 seconds static stretches will be conducted.
15945537|NCT03298776|Device|I-Scan|I-Scan is a digital enhancement technique. These endoscopes already have greater definition compared to many standard endoscopes but they also utilise a 'zoom' function and digital image enhancement.
15945538|NCT03298776|Diagnostic Test|Standard endoscopy|Patients referred for standard endoscopy to receive standard of care only
15945539|NCT03298763|Genetic|MSCTRAIL|"3 doses of MSCTRAIL, administered as an intravenous 60 minutes infusion over 3 cycles, in combination with standard chemotherapy (Cisplatin/Pemetrexed).
~After 3 cycles patients will have 1-3 further treatment of pemetrexed and cisplatin without MSCTRAIL."
15945540|NCT03298763|Drug|Placebo|Placebo will be made up of the same material used to cryopreserve the ATIMP (MSCTRAIL) but will not include the active product
15945541|NCT03298750|Procedure|Resection of ovarian tissue and mechanical stimulation|"he women will undergo a surgical laparoscopy during which one of the two technique will ensue.
~One of the ovaries will be scratched ( 2 mm depth) with a knife. Simultaneously, a piece of the ovary will be preserved for further histologic analysis and research in the laboratory.
~A piece of one ovary will be resected (up to one third of the ovary's volume, without harming the other ovary.
~The resected ovarian tissue will be transferred immediately to the laboratory where the cortex will be divided from the medulla and sliced to small pieces of 1-2 square millimeters.
~These pieces will be transferred back to the operation room in order for them to be transplanted under the serosa layer of the remaining ovary.
~Any bleeding would be stopped using a stiches or hemostatic mesh (diathermy will not be used).
~Simultaneously, a piece of the ovary will be preserved for further histologic analysis and research in the laboratory."
15945542|NCT03298737|Behavioral|Covert Spatial Attention|"During behavioral sessions, subjects will sit in a dark room and view a video monitor placed at the minimum of 57 cm distance away from the subject. Staff will be present throughout all the testing to assist the subject and monitor equipment that is used for tracking their eye position. Subjects will be asked to maintain their heads in a stable position of rest in order to insure accurate tracking of their eye position. To stabilize their head, subjects will either use a chin rest in which they position their chin on a soft pad mounted in front of a video screen, or they may use a bite bar."
15945543|NCT03298724|Behavioral|Teachers and Parents as Partners|A family-school partnership intervention to improve the home-school connection, parenting and teaching strategies, and child behavior outcomes.
15945544|NCT03298698|Drug|Rituximab|Rituximab: 375 mg/m2 intravenously on day 0 and day 14 B-cells will be monitored weekly, and if no complete depletion is achieved, additional dose(s) of Rituximab will be given at a weekly interval until complete B cell depletion (maximum of 2 additional doses).
15945545|NCT03298698|Drug|Prednisone|Prednisone 1 mg/kg/day (max 80 mg/day) for 8 weeks
15945546|NCT03298685|Other|semi structured interviews for all adolescents and their parent|Before and after transition, individual semi structured interviews will be recorded by one person in the same way in all CF center. And every interview will be transcribed by an other person
15945547|NCT03298672|Drug|NDX-1017|Solution of NDX-1017 for subcutaneous injection
15945548|NCT03298672|Drug|Placebo|Placebo solution for subcutaneous injection
15945549|NCT03298659|Diagnostic Test|iFR|Treatment guided by instantaneous wave-free ratio
15945550|NCT03298659|Diagnostic Test|CMR|Treatment guided by stress perfusion CMR
15945551|NCT03298646|Drug|Lidocaine Hydrochloride|10 ml of 2% lidocaine on hysteroscopic infusion media during office hysteroscopy.
15945552|NCT03298646|Drug|Diclofenac|100 mg Diclofenac oral tablet one hour before the procedure.
15945553|NCT03298633|Other|ICSI|All patients will receive controlled ovarian hyperstimulation (COH) treatment, which is performed by standard routines at each study center. The COH treatment includes either gonadotrophin-releasing hormone agonist (GnRH-a) protocol or gonadotrophin-releasing hormone antagonist (GnRH-ant) protocol.Oocyte retrieval is scheduled for 36 (±2) after hCG injection.The retrieved cumulus oocyte complexes (COC) will be allocated to undergo routine ICSI procedure according to the result of randomization in each study site.
15945554|NCT03298633|Other|Conventional IVF|All patients will receive controlled ovarian hyperstimulation (COH) treatment, which is performed by standard routines at each study center. The COH treatment includes either gonadotrophin-releasing hormone agonist (GnRH-a) protocol or gonadotrophin-releasing hormone antagonist (GnRH-ant) protocol.Oocyte retrieval is scheduled for 36 (±2) after hCG injection.The retrieved cumulus oocyte complexes (COC) will be allocated to undergo conventional IVF procedure according to the result of randomization in each study site.
15945555|NCT03298620|Other|Electric toothbrush|
15945556|NCT03298620|Other|Control|Manual toothbrush
15945557|NCT03298607|Dietary Supplement|Placebo|2 months treatment
15945558|NCT03298607|Dietary Supplement|Serelys PMS|2 months treatment
15945559|NCT03298594|Diagnostic Test|specific cervicograph|
15945560|NCT03298581|Drug|Halobetasol Propionate|Experimental: Treatment with topical halobetasol spray 0.05% Patients will instructed o apply halobetasol spray twice daily for 28 days and not to rub over the affected area after application of spray.
15945561|NCT03298568|Dietary Supplement|DAOsin|DAOsin is a food supplement for special medical purpose for the treatment of food intolerance provoked by histamine intake.
15945562|NCT03298555|Behavioral|Mobile phone based intervention|Participants in the intervention group will receive a 6-month mobile phone based program via a mobile phone application specifically designed for this study. The program will include information, advice and strategies to promote healthy gestational weight gain.
15945563|NCT03298542|Drug|Golimumab|Participants will receive subcutaneous golimumab for 26 weeks, where doses will be based on weight and/or body surface area.
15945564|NCT03298542|Drug|Placebo|Matching placebo to golimumab.
15945565|NCT03298529|Other|glucose solution|12 healthy subjects, aged 18-65 years, after a 10 to 12-hour overnight fasting period will assume standard food, a glucose solution at 50%
15945566|NCT03298529|Other|Traditional egg pasta|12 healthy subjects, aged 18-65 years, after a 10 to 12-hour overnight fasting period will assume traditional pasta, with 8 eggs/kg flour. The serving size must contain 50 g of carbohydrates, calculated according to nutritional label
15945567|NCT03298529|Other|Pasta with eight egg whites/kg flour|12 healthy subjects, aged 18-65 years, after a 10 to 12-hour overnight fasting period will assume pasta, with eight egg whites/kg flour. The serving size must contain 50 g of carbohydrates, calculated according to nutritional label
15945568|NCT03298529|Other|Pasta with four eggs/kg flour|12 healthy subjects, aged 18-65 years, after a 10 to 12-hour overnight fasting period will assume pasta, with four egg whites/kg flour. The serving size must contain 50 g of carbohydrates, calculated according to nutritional label
15945569|NCT03298529|Other|Hyperproteic pasta (with added gluten and albumin)|12 healthy subjects, aged 18-65 years, after a 10 to 12-hour overnight fasting period will assume pasta with added gluten and albumin.The serving size must contain 50 g of carbohydrates, calculated according to nutritional label
15945570|NCT03298529|Other|Pasta with only four egg whites/kg flour|12 healthy subjects, aged 18-65 years, after a 10 to 12-hour overnight fasting period will assume pasta with four egg whites/kg flour. The serving size must contain 50 g of carbohydrates, calculated according to nutritional label
15945571|NCT03298516|Drug|DCLL9718S|DCLL9718S will be administered as per the schedule specified in the respective arm.
15945572|NCT03298516|Drug|Azacitidine|Azacitidine will be administered as per the schedule specified in the respective arm.
15945573|NCT03298503|Other|task-priority strategies|"posture-focus strategy: when performing postural-suprapostural task (dual-task), the patient mainly focus on postural task (standing/walking).
~supraposture-focus strategy: when performing postural-suprapostural task (dual-task), the patient mainly focus on suprapostural task (stabilize the tray)."
15945574|NCT03298477|Device|Nellix® System|Endovascular Abdominal Aortic Aneurysm Repair using the Nellix® System
15945575|NCT03298464|Biological|NGM313|Subcutaneous injection
15945576|NCT03298464|Drug|Pioglitazone|White to off-white round tablet
15945583|NCT03298425|Device|Treatment NMES|Muscle stimulation to reproduce an active muscle contraction. CE marked used for intended purpose.
15945584|NCT03298425|Device|Placebo NMES|TENS machine to mimic an active muscle contraction. CE marked used for intended purpose.
15945585|NCT03298412|Drug|Blinatumomab|Blinatumomab is administered as a continuous IV infusion.
15945586|NCT03298399|Biological|Autologous MSCs|Participants at dose level 1 receive four infusions of MSCs, given once per week. The first MSC infusion will be given no sooner than 4 hours after the bone marrow transplant. The total number of cells delivered to each patient will depend on their weight and assigned dose level. The maximal individual dose of MSCs any patient will receive is 2 x 10^6 cells/kg, which will be delivered via intravenous infusion. The infusion can be administered to patients in the inpatient or outpatient setting.
15945587|NCT03298399|Biological|Autologous MSCs|Participants at dose level 2 receive four infusions of MSCs, given twice per week. The first MSC infusion will be given no sooner than 4 hours after the bone marrow transplant. The total number of cells delivered to each patient will depend on their weight and assigned dose level. The maximal individual dose of MSCs any patient will receive is 2 x 10^6 cells/kg, which will be delivered via intravenous infusion. The infusion can be administered to patients in the inpatient or outpatient setting.
15945588|NCT03298399|Biological|Autologous MSCs|Participants at dose level 3 receive six infusions of MSCs, given twice per week. The first MSC infusion will be given no sooner than 4 hours after the bone marrow transplant. The total number of cells delivered to each patient will depend on their weight and assigned dose level. The maximal individual dose of MSCs any patient will receive is 2 x 10^6 cells/kg, which will be delivered via intravenous infusion. The infusion can be administered to patients in the inpatient or outpatient setting.
15945589|NCT03298386|Other|Systematic medication review with the STOPP/START tool|The STOPP / START tool includes a list of 42 substances / drug classes whose prescription could be discontinued based on specific criteria (81 STOPP criteria: Screening Tool of Older Person's Prescriptions) and a list of 34 clinical situations involving consideration of the usefulness of a new prescription (START criteria: Screening Tool to Action the Right Treatment).
15945590|NCT03298373|Drug|Placebo|Placebo capsules that look like the 11β-MNTDC capsules but with no active ingredients.
15945591|NCT03298373|Drug|11β-methyl-nortestosterone-dodecylcarbonate|11β-MNTDC doses in castor oil/benzyl benzoate capsules (100 mg each) administered in 200 mg or 400 mg doses orally.
15945592|NCT03298360|Other|Blood sample|167mL of blood in EDTA tube will be obtained on a research visit, after signature of written informed consent
15945593|NCT03298347|Drug|80mg/kg of caffeine|80mg/kg of caffeine is given to treat AOP
15945594|NCT03298347|Drug|20mg/kg of caffeine|20mg/kg of caffeine is given to treat AOP
15945595|NCT03298334|Biological|Vaginal Seeding|A gauze containing the Mother's vaginal flora will be swabbed over the face and body of the neonate shortly after cesarean delivery.
15945596|NCT03298334|Other|No Vaginal Seeding|A gauze carrying sterile saline will be swabbed over the face and body of the neonate shortly after cesarean delivery.
15945713|NCT03297502|Drug|pimecrolimus cream 1%|
15945714|NCT03297502|Drug|Elidel (pimecrolimus) cream 1%|
15945599|NCT03298295|Device|Continous Subcutaneous Insulin Infusion Catheter|Catheters will be inserted into the abdomen of each patient using aseptic technique according to the following schedule: (1) 8 days before surgery, (2) 4 days before surgery and (3) 1 day before surgery (Table 1). At each time point 2 steel (Medtronic Sure-T, 9 mm) and 2 Teflon (Medtronic Quick-set®, 9 mm) CSII catheters will be inserted into the subcutaneous abdominal tissue. In total, 12 catheters will be inserted into each patient's abdomen using only the area predefined by the plastic surgeon for removal.
15945600|NCT03298282|Other|OCT (Optical Coherence Tomography)|Coronary images by OCT and selective CTA and FFR values will be registered.
15945601|NCT03298282|Other|Coronary CTA|Coronary images by OCT and Coronary CTA and FFR values will be registered.
15945602|NCT03298282|Other|FFR|Coronary images by OCT and selective CTA and FFR values will be registered.
15945603|NCT03298269|Behavioral|Mindfulness-Oriented Recovery Enhancement|Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention led by a therapist that combines training in mindfulness, cognitive reappraisal, and savoring skills.
15945604|NCT03298269|Behavioral|Supportive Counseling|A support group led by a therapist will allow participants to express emotions, share experiences, and receive social support.
15945605|NCT03298256|Radiation|EOS X-rays|Full length, orthogonal anteroposterior and lateral X-rays will be taken simultaneously in a standardised standing position, with arms folded anteriorly in 45 degrees . All radiographs will include C7 proximally and the femoral heads distally. 3D reconstruction of the spine can be performed. X-rays will be repeated after the brace is applied, and at intervals of no fewer than 6 months until the brace is weaned off, or if surgical intervention is required. Coronal, sagittal and axial parameters will be calculated from the reconstruction. 3D vertebral wedging will be calculated in the posterofrontal, sagittal and diagonal planes at the apex, 3 superior and 3 inferior vertebrae, as described by Scherrer et al. Changes in the pre- and post-bracing and follow-up parameters can be calculated.
15945606|NCT03298243|Behavioral|Vibrotactile stimulation|Non-invasive, computer-controlled miniature tendon vibrators, similar to those used in FitBit activity monitors.
15945607|NCT03298230|Behavioral|REmotely SuPervised Exercise Training|As described in the Arms section.
15945608|NCT03298230|Behavioral|Supervised Exercise Training|As described in the Arms section.
15945609|NCT03298217|Device|Measurement of the peak tidal inspiratory flow (PTIF)|"In patients with bronchiolitis sverity mWCAS / 3-5 :
~Nasopharyngeal aspiration and comfortable placement of the infant upon admission; Clinical evaluation: respiratory rate, respiratory distress scores rating (Silverman and m-WCAS); If the patient is eligible: information and collection of parental consent; If signed parental consent obtained: progressive (on at least 10 min) withdrawal of HFNC support and maintenance if necessary of conventional oxygen therapy (maximum 1 L/min); Application of the spirometer for the recording of 20 consecutive spontaneous respiratory cycles for PTIF measurements; Respiratory support with HFNC; flow adapted to the need of the patients (equal to the measured PTIF)."
15945610|NCT03298191|Drug|Magnesium Sulfate|Those women will be given Magnesium Sulfate for tocolysis
15945611|NCT03298191|Drug|Ritodrine|Those women will be given Ritodrine for tocolysis
15945612|NCT03298191|Drug|Calcium Channel Blockers|Those women will be given Calcium Channel Blockers for tocolysis
15945613|NCT03298178|Procedure|TAVR|All patients who underwent transcatheter aortic valve replacement in Asan medical center, republic of Korea
15945614|NCT03298178|Procedure|SAVR|All patients who underwent surgical aortic valve replacement in Asan medical center, republic of Korea
15945615|NCT03298165|Device|diode laser|diode laser has antibacterial effect so can disinfect deep cavity and decrease the count of bacteria present after stepwise excavation
15945616|NCT03298152|Procedure|CERASMART Endocrown|Endocrown fixed restoration used to restore endodontically treated anterior teeth using CERASMART blocks
15945617|NCT03298152|Procedure|Emax Endocrown|Endocrown fixed restoration used to restore endodontically treated anterior teeth using Emax material
15945618|NCT03298139|Other|3 levels of gravity (1G, 1.8G, 0G).|healthy volunteers will experience 3 levels of gravity (1G, 1.8G, 0G).
15945619|NCT03298126|Procedure|TR BAND removal protocol|To assess radial artery patency after specific protocol used as already described in previous section.
15945620|NCT03298113|Device|Cavilon Advanced Skin Protectant|Applicator contains a polymeric-cyanoacrylate solution intended to cover and protect intact or damaged skin. Upon application to skin, the liquid dries rapidly to form a primary long-lasting waterproof, highly durable film barrier.
15945621|NCT03298113|Device|IAD Hospital Standard Care|Devices such as local skin protectants will be used according to the hospital IAD care regime and under consideration of the respective manufacturers' instructions for use.
15945622|NCT03298100|Other|Scoring model|Determining risk factors an calculating the risk score, recurrent vaginal bleeding 3, hypertension 2, age and endometrial thickness 1 for each
15945623|NCT03298087|Procedure|radical prostatectomy|surgical removal of the prostate
15945624|NCT03298087|Radiation|stereotactic body radiotherapy|Highly targeted radiation
15945625|NCT03298087|Drug|Leuprolide|Lowers serum testosterone
15945626|NCT03298087|Drug|apalutamide|antiandrogen
15945627|NCT03298087|Drug|abiraterone|Inhibits androgen synthesis
15945628|NCT03298074|Drug|Apatinib|Apatinib, 500mg,po qd for continuous administration
15945629|NCT03298074|Drug|Etoposide|Etoposide,100mg, PO.QD，D1-D10, Q3W
15945630|NCT03298061|Drug|Mepolizumab|Mepolizumab will be available as lyophilized powder for injection to be reconstituted with sterile water for injection, prior to use. Subjects will be dosed with mepolizumab at a dose of 300 mg which will be administered as three separate 100 mg SC injections every 4 weeks. The injections will be administered into any of the upper arm, thigh or anterior abdominal wall.
15945631|NCT03298061|Drug|Prednisolone|Subjects who require a dose of prednisolone (or equivalent) of 5 mg/day for adequate control of their EGPA will be included.
15945632|NCT03298048|Biological|Low fecal microbiota dose|receiving healthy microbiota (PRIM-DJ2727) collected from 50g stool for 2 consecutive days
15945633|NCT03298048|Biological|Mid fecal microbiota dose|receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool on the 1st day of treatment and from 50g stool on the 2nd day of the treatment
15945634|NCT03298048|Biological|High fecal microbiota dose|receiving healthy microbiota (PRIM-DJ2727) collected from 100g stool for 2 consecutive days
15945715|NCT03297502|Drug|placebo|
15945635|NCT03298035|Device|NCPAP as mode for apnea prevention|With recurrence of apneic events, infants on NCPAP will have changes made in NCPAP settings per the clinical team's discretion in attempt to prevent future apneic events. If apneic events persist despite NCPAP adjustments, clinicians may intubate based on clinical judgment.
15945636|NCT03298035|Device|NIPPV as rescue mode for apnea prevention|With recurrence of apneic events, infants will be placed on NIPPV with settings and adjustments per the clinical team's discretion. If apneic events persist despite NIPPV placement and setting adjustments, clinicians may intubate based on clinical judgment.
15945637|NCT03298022|Biological|AbGn-168H|monoclonal antibody
15945638|NCT03298009|Drug|Canagliflozin 100mg|2-week intervention
15945639|NCT03298009|Drug|Placebo oral capsule|2-week intervention
15945640|NCT03298009|Radiation|PET imaging|1 day postprandial metabolic protocol at the end of treatment: CT scan followed by dynamic and pancorporel imaging
15945641|NCT03297996|Diagnostic Test|Mobio PowerSoil DNA Isolation Kit|16S rRNA amplicons covering variable regions V3 to V4 were generated using primers (347F-5'GGAGGCAGCAGTRRGGAAT'-3' and 803R 5'-CTACCRGGGTATCTAATCC-3') incorporating Roche 454 FLX Titanium adapters (Branford, CT) and a sample barcode sequence
15945642|NCT03297983|Drug|M7583|Subject will receive either M7583 PiC or M7583 tablet formulation orally under fasted conditions in part 1 followed by M7583 tablet formulation under fed condition in part 2 of the study.
15945643|NCT03297957|Device|Hands-free goggle system|-Manufactured at Washington University
15945644|NCT03297944|Drug|Alprazolam 2mg (2ALP/PLC)|2mg alprazolam administered at night, placebo administered in the morning.
15945645|NCT03297944|Drug|Alprazolam 1mg (1ALP/PLC)|1mg alprazolam administered at night, placebo administered in the morning.
15945646|NCT03297944|Drug|Alprazolam 0.5mg (0.5ALP/PLC)|0.5mg alprazolam administered at night, placebo administered in the morning.
15945647|NCT03297944|Drug|Zolpidem 10mg (ZOL/PLC)|10mg alprazolam administered at night, placebo administered in the morning.
15945648|NCT03297944|Drug|Placebo (PLC/PLC)|Placebo administered at night, placebo administered in the morning.
15945649|NCT03297944|Drug|Alprazolam 1mg (PLC/ALC)|Placebo administered at night, 1mg alprazolam administered in the morning.
15945650|NCT03297931|Dietary Supplement|Corn Chips + Onion Dip|Non-pulse chip + non-pulse dip
15945651|NCT03297931|Dietary Supplement|Yellow pea chip + hummus|Novel pulse chip + pulse spread
15945652|NCT03297931|Dietary Supplement|Pinto bean chip + hummus|Commercial pulse chip + pulse spread
15945653|NCT03297931|Dietary Supplement|Pinto bean chip + onion dip|Commercial pulse chip + non-pulse spread
15945654|NCT03297931|Dietary Supplement|Yellow pea chip + onion dip|Novel pulse chip + non-pulse spread
15945655|NCT03297931|Dietary Supplement|Corn chips + hummus|Non-pulse chip + pulse spread
15945656|NCT03297918|Behavioral|Respiratory muscle training|The intervention is two-parted and includes weekly singing lessons in a choir, held by a professional instructor, with additional instructions for daily breathing exercise at home.
15945657|NCT03297905|Behavioral|Complementary and Integrative Therapies|Intervention time period is 3 - 6 weeks.
15945658|NCT03297905|Behavioral|Standard Rehabilitative Care|Intervention time period is 3 - 6 weeks.
15945659|NCT03297879|Drug|Exenatide or metformin hydrochloride|Exenatide was administrated with 5 μg bid for 4 weeks and 10 μg bid for 8 weeks. Metformin hydrochloride was initiated at a dose of 500 mg bid for 2 weeks, and added to 2.0 g/day for 8 weeks.
15945660|NCT03297840|Behavioral|Dialectical Behavioural Therapy (DBT)|Inpatient Dialectical Behavioural Therapy (DBT) according to Linehan.
15945661|NCT03297827|Other|Serum and Urine measurement of cytokines.|To evaluate serum cytokine levels and identifying serum inflammatory markers (serum interleukin-33, IL-37, IL-36, IL-4, IL-6, IL-10, IL-17, IL-23, IL-1, TNF, PDGF, VEGFM TNFa, ANNULIN, MMP-9, MMP-12, NFk-B levels plus metabolic products like MPO, etc and glial factors like GMF, SI000B, GM6001) in patients with acute ischemic & hemorrhagic stroke.
15945662|NCT03297814|Biological|Platelet lysate|Intramuscular injection of platelet lysate
15945663|NCT03297814|Biological|Placebo|intramuscular injection of normal saline
15945664|NCT03297801|Dietary Supplement|Fish oil supplements|Women who chose to supplement with fish oil during gestation or lactation.
15945665|NCT03297788|Radiation|SRS|"For SRS the dose prescription to the PTV will be as follows:
~20 Gy to the 70%-isodose (lesions < 2 cm max. diameter)
~18 Gy to the 70%-isodose (lesions 2 - 3 cm max. diameter)
~6 x 5 Gy to the conformally surrounding isodose (lesions > 3 cm max. diameter)"
15945666|NCT03297788|Radiation|WBRT|WBRT will be applied in 10 fractions with single doses of 3 Gy to the whole brain.
15945667|NCT03297762|Behavioral|gamification|incentives/rewards and contact between standard visits
15945668|NCT03297762|Behavioral|Use of Dexcom G5|Dexcom G5 continuous glucose monitor
15945669|NCT03297749|Other|Observational study (no intervention)|No interventions
15945670|NCT03297736|Device|3D CAD/CAM autograft prosthesis|Surgical ossicular reconstruction with the experimental autograft prosthesis created using 3D subtraction CAD/CAM.
15945671|NCT03297736|Device|Control device|Surgical ossicular reconstruction with the standard available middle ear prosthesis.
15945672|NCT03297723|Other|Therapeutic education Programm|"Intervention will include:
~an identification of educational needs and expectations,
~a bilateral agreement between patient and medical staff on the priority skills acquirement,
~a structured educational activities tailored to the patient's need.
~the making of an educational record."
15945673|NCT03297710|Other|Quality-of-Life Assessment|Ancillary studies
15945674|NCT03297710|Radiation|Radiation Therapy|Undergo radiation therapy
15945675|NCT03297710|Drug|Trifluridine/Tipiracil Hydrochloride Combination Agent TAS-102|Given PO
15945676|NCT03297697|Procedure|Tumor biopsy|Biopsy specimen can be from bone marrow, blood, or lymph node. This specimen should have a high disease load
15945677|NCT03297697|Procedure|Peripheral blood draw|-Baseline, C1D1, C1D8, C1D15, C2D1, C3D1, C4D1, C5D1, C6D1, end of treatment, 3 month follow-up (optional), 6 month follow-up, 9 month follow-up (optional), 12 month follow-up, 15 month follow-up (optional), 18 month follow-up, 21 month follow-up (optional), 24 month follow-up, and at relapse
15945678|NCT03297697|Procedure|Lymphotrack TCR clonality assay|-Assay with high sensitivity that can be performed with peripheral blood
15945679|NCT03297684|Drug|Aflibercept Injection [Eylea]|Intravitreal injection aflibercept
15945683|NCT03297658|Device|electro-acupuncture (EA)|stimulation of acupuncture points related to congenital heart surgery for comfort heart and renal health
15945684|NCT03297658|Device|sham|Micro electrodes will be placed but there will be no stimulation
15945685|NCT03297645|Behavioral|School|CHWs will ensure that families submit required health paperwork (e.g., asthma action plan, medication release form) and confirm with school nurses that children have the appropriate medications. School nurses will be given a standardized protocol to follow with clear guidelines for caring for students with asthma. The CHW assigned to the family will work with the school nurse to ensure that communication with the medical provider is occurring.
15945686|NCT03297645|Behavioral|Asthma education|CHWs will deliver evidence-based asthma education to parents and children. Content is drawn from existing asthma management programs, and adapted for families in Richmond. Between sessions, CHWs will call parents at least monthly to check in and assess family asthma management, including healthcare utilization since the last contact.
15945687|NCT03297645|Behavioral|Home environmental remediation|Healthy Homes will complete home-based environmental assessments using evidence-based protocols. Healthy Homes will provide real-time education and share information about their findings and recommendations for action. Families are provided with low-cost intervention materials (e.g., filters, pillow covers), as well as behavioral modifications to aid in the reduction of asthma triggers in the home.
15945688|NCT03297645|Behavioral|Informational mail|Family will be mailed publicly available asthma information every 3 months.
15945689|NCT03297632|Behavioral|Functional resistance exercise|Functional resistance program designed for older individuals with low muscle mass and muscle strength. The goal is to implement exercises that are possible for the participants to also perform in their home environment, through the use of basic equipment.
15945690|NCT03297619|Behavioral|Mindfulness and Acceptance Workbook for Social Anxiety and Shyness|Participants assigned to this condition will be asked to read this self-help book over an 8-week period.
15945691|NCT03297619|Behavioral|The Shyness and Social Anxiety Workbook|Participants assigned to this condition will be asked to read this self-help book over an 8-week period (with some chapters omitted).
15945692|NCT03297606|Drug|Olaparib|300mg taken twice daily
15945693|NCT03297606|Drug|Dasatinib|100mg administered orally once daily
15945694|NCT03297606|Drug|Nivolumab plus Ipilimumab|"Combination Phase - 3mg/kg nivolumab administered as an intravenous infusion over 30 minutes every 3 weeks for the first 4 doses in combination with ipilmumab 1mg/kg administered intravenously over 30 minutes, followed by the single-agent phase.
~Single-Agent Phase - 480mg nivolumab administered as an intravenous infusion over 30 minutes every 4 weeks."
15945695|NCT03297606|Drug|Axitinib|5mg orally twice daily
15945696|NCT03297606|Drug|Bosutinib|500mg orally once daily
15945697|NCT03297606|Drug|Crizotinib|250mg orally twice daily
15945698|NCT03297606|Drug|Palbociclib|125mg orally once daily for 21 consecutive days followed by 7 days off treatment to comprise a complete cycle of 28 days
15945699|NCT03297606|Drug|Sunitinib|50mg orally once daily on a schedule of 4 weeks on treatment followed by 2 weeks off
15945700|NCT03297606|Drug|Temsirolimus|25mg infused over a 30-60 minute period once a week
15945701|NCT03297606|Drug|Erlotinib|150mg orally, once daily
15945702|NCT03297606|Drug|Trastuzumab plus Pertuzumab|"Trastuzumab = 3-weekly dose schedule. The recommended initial loading dose is 8mg/kg administered as a 90-minute infusion followed by 3-weekly maintenance dose of 6mg/kg administered as 90-minute infusion.
~Pertuzumab = 840mg administered as a 60-minute intravenous infusion, followed every 3 weeks thereafter by a dose of 420mg administered over a period of 30-60 minutes."
15945703|NCT03297606|Drug|Vemurafenib plus Cobimetinib|"Vemurafenib = 960 mg orally every 12 hours.
~Cobimetinib = 60 mg orally once daily for 21 days, followed by 7 days of rest"
15945704|NCT03297606|Drug|Vismodegib|150mg taken orally, once daily
15945705|NCT03297593|Drug|nivolumab|240 mg every 2 weeks during the first 20 weeks, 480 mg every 4 weeks thereafter
15945706|NCT03297593|Drug|ipilimumab|After 2 weeks 1mg/kg every 6 weeks
15945707|NCT03297567|Behavioral|verbal guidance and a booklet|Patients allocated to the intervention group will receive verbal instruction from the researchers on the importance and benefits of movement during hospital stay, as well as what they should do to increase the level of physical activity. These patients will receive the same guidelines through a playable, easy-to-understand and inexpensive booklet developed by the researchers themselves in PowerPoint 2016 (Microsoft) in order to remedy any doubt or forgetfulness during the hospitalization period
15945708|NCT03297554|Behavioral|m-Health Intervention|Parent/child dyads attend remote counseling sessions delivered over Internet-connected device (e.g. smartphone, iPad/tablet, laptop, or desktop computer). A counselor will deliver the lesson, review progress based on the objectively measured data, and provide individualized advice and problem-solving strategies for parent and child. Families will receive weekly contact via smartphone. Each lesson will include an interactive component for parent and child related to healthy eating and active play, as well as an interactive parenting training component. Lessons are based on the family treatment methods that effectively promote child and parent weight loss that is sustained for 10 years (Epstein et al., 1990; Epstein et al., 1981).
15945709|NCT03297541|Behavioral|m-health approach|Parent/child dyads attend remote counseling sessions delivered over Internet-connected device (e.g. smartphone, iPad/tablet, laptop, or desktop computer). A counselor will deliver the lesson, review progress based on the objectively measured data, and provide individualized advice and problem-solving strategies for parent and child. Families will receive weekly contact via smartphone. Each lesson will include an interactive component for parent and child related to healthy eating and active play, as well as an interactive parenting training component. Lessons are based on the family treatment methods that effectively promote child and parent weight loss that is sustained for 10 years (Epstein et al., 1990; Epstein et al., 1981).
15945710|NCT03297528|Drug|donor lymphocyte infusion|Participants in study group receive chemotherapy and donor lymphocyte infusion based on the state of GvHD, even they have a negative result of MRD. If participants in study group have no GvHD, they will receive chemotherapy and donor lymphocyte infusion until they develop GvHD. If the participants in study group have GvHD, they will be observed. But, the participants in control group don't receive chemotherapy and donor lymphocyte infusion as long as they have a negative result of MRD, in despite of whether or not GvHD.
15945711|NCT03297515|Dietary Supplement|Madeos|Arm 1: Omega 3
15945712|NCT03297515|Dietary Supplement|Placebo|Arm 2 : Placebo
15945719|NCT03297476|Diagnostic Test|High-risk subtype detection panels|The designed detection technology were used to identify the high-risk patients cohort.
15945720|NCT03297463|Drug|Interleukin-2 & Ipilimumab (P-Ib)|"Phase Ib:
~- Ipilimumab will be administered in a 3 + 3 dose escalation design.
~The starting dose will be 0.3 mg/kg administered within 7 days of day 1 cycle 2 ALdesleukin (IL-2).
~If dose limiting autoimmune toxicities (DLTs) are not observed, the next cohort will receive 1.5 mg/kg.
~The final cohort will receive 3 mg/kg, in the event that cohort 2 does not exhibit DLTs.
~In the event of excessive toxicity in cohort 1, then a -1 dose level of 0.1 mg/kg may be evaluated in subsequent cohorts. Cohort sizes will increase to 6 patients if 1 of 3 patients in a cohort experience a DLT.
~Once the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D) is declared, no staggering of enrollment is required for accrual."
15945721|NCT03297463|Drug|Interleukin-2 & Ipilimumab (P-II)|"Phase II:
~- Interleukin-2 & Ipilimumab will be administered at the maximum tolerated dose/recommended phase 2 dose (MTD/RP2D)."
15945722|NCT03297450|Device|tDCS|C-tDCS during the first 20 minutes of aphasia therapy, at an intensity of 1mA
15945723|NCT03297450|Behavioral|Aphasia therapy|Based on linguistic tests, individualized aphasia therapy will be provided
15945724|NCT03297450|Device|Sham-tDCS|tDCS during the first 20 minutes of aphasia therapy at an intensity of 0mA (Sham)
15945725|NCT03297437|Other|Neurofeedback training|In a neurofeedback setting, brain activity is measured non-invasively, the brain imaging data is analyzed in real-time, and then feedback regarding the current level of brain activity is provided to the subject.
15945726|NCT03297424|Drug|PLX2853|tablets
15945727|NCT03297411|Procedure|Brief Temporoparietal ECT|Electroconvulsive Therapy (Brief pulse width, Temporoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.
15945728|NCT03297411|Procedure|Ultrabrief Temporoparietal ECT|Electroconvulsive Therapy (Ultrabrief pulse width, Temporoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.
15945729|NCT03297411|Procedure|Brief Frontoparietal ECT|Electroconvulsive Therapy (Brief pulse width, Frontoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.
15945730|NCT03297411|Procedure|Ultrabrief Frontoparietal ECT|Electroconvulsive Therapy (Ultrabrief pulse width, Frontoparietal) The intervention in this study is different combinations of pulse width and ECT electrode placements.
15945731|NCT03297398|Drug|Group-1 (15mg, OPK-88004)|15mg, OPK-88004
15945732|NCT03297398|Drug|Group-2 (25 mg,OPK-88004)|25 mg,OPK-88004
15945733|NCT03297398|Other|Placebo|Placebo
15945734|NCT03297385|Drug|Enzalutamide|Men with localized prostate cancer will undergo an additional set of targeted tumor biopsies and will be subsequently treated with 3 months of enzalutamide. The prostatectomy specimen will be additionally sampled, ex vivo.
15945735|NCT03297372|Device|IOL implantation|Implantation of monofocal IOL Micropure 1.2.3
15945736|NCT03297359|Biological|Dalteparin|daily subcutaneous injection of weight-adjusted dalteparin
15945737|NCT03297346|Other|Cardiac imaging and circulating biomarkers|Automated 2D-speckle-tracking echocardiography (ECHO-ST); Computed tomography coronary angiography (CT); Cardiac magnetic resonance imaging (MRI); Blood samples for circulating biomarkers measurements (BLOOD)
15945738|NCT03297333|Other|Resistance training|The resistance training group
15945739|NCT03297333|Other|Aerobic interval training|The aerobic interval training group
15945740|NCT03297320|Other|In-depth conversation about Goals of Care and ACP|In-depth conversation regarding Goals of Care and ACP by an experienced practitioner
15945741|NCT03297307|Behavioral|Presurgical Counseling|Children will attend the presurgical counseling visits with their mother
15945742|NCT03297294|Drug|EMA401|capsules, oral
15945743|NCT03297294|Drug|Placebo|Placebo to EMA401 capsules, oral
15945744|NCT03297281|Other|Maintenance of OAC in surgery of BPH by PVP.|The maintenance of AVK or DOACs treatment in the perioperative setting (without interruption of oral treatment).
15945745|NCT03297281|Other|Discontinuation of OAC in surgery of BPH by PVP.|The discontinuation of AVK or DOACs treatment with perioperative heparin relay during postoperative course.
15945746|NCT03297268|Other|Intervention with Home-Based Caregivers|We will assess whether real-time notifications of potential agitation via a wearable wrist device improves caregiver self-efficacy.
15945747|NCT03297229|Behavioral|Peer mentoring|Peers will be assigned to participants according to common socio-demographic characteristics. Each peer will be assigned up to 5 participants.
15945748|NCT03297229|Behavioral|Self-monitoring|"Along with providing patients with a BP monitor, a commitment contract will be signed, in which participants commit themselves to measure their blood pressure at home at least once a week during the 3 months of the intervention. Each participant will be given a form to weekly recording their blood pressure values."
15945749|NCT03297216|Drug|17P|Synthetic progestin
15945750|NCT03297216|Other|Placebo|Non-active placebo comparator
15945751|NCT03297203|Behavioral|Blood sample|The investigators will take two kits of blood samples for the group 1, one during the early stage of the septic shock (48 first hours of care) and one during the late stage of the disease (between the fourth and the sixth day). We'll take only one kit of blood samples for the group 2. One kit includes one EDTA tube (5 mL) and five Lithium Heparin tubes (25 mL). The immune mapping will be made by Julien Carvelli, a gold medalist resident, in the framework of a Master 2. The analyses will be made in the laboratory of immunology in the Conception Hospital (Pr Vivier's team).
15945752|NCT03297190|Behavioral|SMS|Receipt of SMS messages on nutrition and health topics
15945753|NCT03297190|Behavioral|Interpersonal Counselling|Interpersonal counselling on health and nutrition topics
15945754|NCT03297177|Procedure|Microcannula Harvest Adipose|Use Closed Syringe Microcannula Harvest Adipose, Autologous Subdermal Deposits
15945755|NCT03297177|Device|Centricyte 1000|Closed System, Digestive Isolation & Concentration of AD-cSVF
15945756|NCT03297177|Procedure|Sterile Normal Saline Infusion|Sterile Normal Saline Re-Suspension of cSVF and Delivery of AD-cSVF via IV route
15945757|NCT03297151|Dietary Supplement|CONTROL|"Food grade mixture of non-essential amino acids in powdered form, flavoured and instantised to be dissolved in water.
~Supplied by Carbery Food Ingredients Limited, Ballineen, Ireland. Product Reference Number 10955"
15946323|NCT03292653|Drug|Placebo|Pharmaceutical form: Tablet; Route of administration: Oral
15945758|NCT03297151|Dietary Supplement|Whey Protein Concentrate|"Whey protein concentrate in powdered form, flavoured and instantised to be dissolved in water.
~Supplied by Carbery Food Ingredients Limited, Ballineen, Ireland. Trade name of product is Carbelac80 Instant Product Reference Number 10431"
15945759|NCT03297151|Dietary Supplement|Whey Protein Hydrolysate|"Whey protein concentrate hydrolysate (degree of hydrolysate 27%) in powdered form, flavoured and instantised to be dissolved in water.
~Supplied by Carbery Food Ingredients Limited, Ballineen, Ireland. Product Reference Number 10468"
15945760|NCT03297138|Procedure|FiLAC laser|The technique consists in applying in a radial way to 360 ° an energy laser in the fistulous route. This energy allows a thermal destruction by coagulation of the wall of the fistula and the fabrics of granulations in a circular and regular way as well as a shrinkage of neighbouring fabrics. The repair is made by a call of macrophages and fibroblasts of neighbouring healthy fabrics so ending in a closure of the fistulous route
15945761|NCT03297125|Device|Standard Magnetic Resonance Imaging (MRI)|Standard MRI.
15945762|NCT03297125|Device|Advanced MRI.|Perfusion and diffusion MRI.
15945763|NCT03297112|Drug|Perflutren Lipid Microspheres|Given IV
15945764|NCT03297112|Procedure|Contrast-Enhanced Subharmonic Ultrasound Imaging|Undergo contrast-enhanced subharmonic ultrasound imaging
15945765|NCT03297099|Procedure|Robot-assisted Laparoscopic operation|Thirty patients with hepatolithiasis were selected and divided into robot group as described in the detailed description. Under general anesthesia, the patient was placed in a supine 30-degree reverse Trendelengburg position with both legs separating. The surgeon work on the console, and assist surgeon stand between legs. Operation began with division of liver ligaments, liver mobilization, followed by intrahepatic access to the Glissonian pedicle . A endoscopic stapler devices was used for Glissonian pedicle cutting and suture. Liver parenchyma was divided by harmonic scalpel combined with vascular stapler.
15945766|NCT03297099|Procedure|open surgery|surgery group as described in the detailed description.Open surgery was performed under general anesthesia with the patient in the supine position. Routinely, a reversed L-shape incision was performed. Operation began with division of liver ligaments, liver mobilization, followed by intrahepatic access to the Glissonian pedicle . A endoscopic stapler devices was used for Glissonian pedicle cutting and suture. Liver parenchyma was divided by harmonic scalpel combined with vascular stapler.
15945767|NCT03297086|Procedure|cataract surgery|cataract surgery with phacoemulsification and implantation of multifocal posterior chamber intraocular lens
15945768|NCT03297073|Drug|paracetamol|"Paracetamol 1000 mg will be administered 30 minutes before the end of the procedure and then every 6 hours systematically at the following times: 6h / 12h / 18h / 00h.
~The analgesic treatment after hepatectomy with paracetamol will be maintained for at least 5 days in all patients in parenteral form"
15945769|NCT03297073|Procedure|hepatic surgery|
15945770|NCT03297060|Other|SSL Implementation Strategy|Science to Service Laboratory (SSL) is an approach developed by the SAMHSA-funded Addiction Technology Transfer Centers (ATTCs) that consists of didactic training + performance feedback + leadership coaching to improve SBIRT adherence within the pediatric trauma center
15945771|NCT03297047|Device|combi cast|upper arm or forearm combi cast
15945772|NCT03297021|Drug|Ondansetron 4 MG|dose as per arm selection
15945773|NCT03297021|Drug|Ondansetron 8mg|dose as per arm selection
15945774|NCT03297008|Other|No internvetion|No intervention, this is an observational study
15945775|NCT03296995|Device|Flash glucose monitoring system|Flash glucose monitoring systems in critically ill patients may improve glycemic control and reduce glucose variability.
15945776|NCT03296982|Other|Blood drawn by direct venipuncture|Subjects will have blood sampled (12 mL/sample) a total of 8 times by direct venipuncture. Samples will be spiked with predetermined concentrations of anticoagulants, or saline sham.
15945777|NCT03296982|Drug|edoxaban|
15945778|NCT03296982|Drug|Enoxaparin|
15945779|NCT03296982|Drug|Saline sham|
15945780|NCT03296969|Procedure|cesarean section|All women underwent Pfnannenstiel incision under general or spinal anaesthesia, with a combination of sharp and blunt dissection to open the abdomen. The rectus muscles are dissected off the fascia, and the muscles are separated in the midline by pulling. Then the uterus is opened followed by fetal and placental extraction. The transverse lower uterine segment incision is closed in two layers of continuous Vicryl number 1 suture. The parietal peritoneum is closed using a continuous absorbable suture. In group (A): rectus muscle re-approximation is done by 3 interrupted sutures, but muscle is not closed in the other group. The rectus sheath is sutured using continuous absorbable sutures. Finally, skin is sutured with subcuticular sutures with Vicryl Rapide
15945781|NCT03296969|Procedure|Rectus muscle approximation|aprroximation of the lower parts of rectus abdomius muscles during cesarean section
15945782|NCT03296956|Dietary Supplement|Motherwell|The interventions involves a dietary supplement called Motherwell, at current stage, to reduce the intensity of sadness in day-5 postpartum women.
15945783|NCT03296956|Other|Placebo|Matching placebo for appearance, taste
15945784|NCT03296943|Combination Product|Essential oil|To inhale the essential oil in an air-conditioned room, the container was flipped over to soak the roll-on cap that was then rolled-on circularly at the right mid-palm of the subject at 2 centimeter in diameter for 5 cycles.
15945785|NCT03296943|Combination Product|Perfume|To inhale the perfume in an air-conditioned room, the container was flipped over to soak the roll-on cap that was then rolled-on circularly at the right mid-palm of the subject at 2 centimeter in diameter for 5 cycles.
15945786|NCT03296943|Behavioral|Cue-induced inhalants craving|Exposing individuals with a set of 12 pictures for one-minute (e.g., 5 second display per picture) every five minutes for three sets in total followed by another three sets of neutral/relaxing pictures of nature.
15945787|NCT03296930|Drug|Sofosbuvir 400 MG Oral Tablet,|Interferon free direct acting antiviral drugs used for treatment of HCV.
15945788|NCT03296930|Drug|Ombitasvir/paritaprevir/ritonavir|Interferon free direct acting antiviral drugs used for treatment of HCV.
15945789|NCT03296917|Drug|PrEP-001|A spray dried powder for intranasal administration formulated from an aqueous mixture of pre-gelatinized waxy maize starch and the drug substance delivered using a single dose nasal powder device.
15945790|NCT03296917|Drug|G-004|A spray dried pre-gelatinized waxy maize starch powder (G-001) in the single dose nasal powder device
15945791|NCT03296904|Device|CLs++|Familiarization/training with the customized combination of the CLs++ ortho-prosthesis modules
15945792|NCT03296891|Other|PoCUS Guided Resuscitation of Shock|Point-of-care ultrasound (PoCUS) will be used to guide resuscitation of the participant with shock. A PoCUS study will consist of limited echocardiography (LE) and thoracic ultrasound (TUS).
15945793|NCT03296878|Other|Own-Price Elasticity|The price of eggs will be 75%, 100%, or 125% of the reference price, but the price of other foods will remain the same.
15945794|NCT03296878|Other|Cross-Price Elasticity|The price of eggs will remain the same, but the price of other foods will be 75%, 100%, or 125% of the reference price.
15945795|NCT03296865|Device|Kinesio taping|"We applied a hypoallergenic, porous and adhesive tape of cotton (Kinesio Tex Gold) placed over Rectus Femoris muscle of the affected limb. Children were taped in accordance to Kenzo Kase's Kinesio manual. We used a facilitation technique, from muscle origin to insertion, in a Y shape. For KT condition: base of the KT strip 3cm below the anterior iliac spine, over the RF muscle until the upper edge of the patella and stretchered with 100% tension. For placebo condition: same technique without tension in the entire tape.
~We verified the immediate effect of KT/placebo. After the evaluation, KT/placebo was removed."
15945796|NCT03296852|Diagnostic Test|SONAS Ultrasound Device|To assess a baseline value, ultrasound will be transmitted following an automated protocol to increase subsequently the output voltage from 5 volts to 50 volts. At each voltage step the received signals will be acquired and stored. Once the maximum output voltage of 50 Volts has been reached an additional 10 ultrasound pulses will be transmitted and the received data acquired. The total duration of this first data acquisition is 20 seconds. Following the IV bolus injection of Lumason™, ultrasound will be transmitted and received signals acquired following the same protocol as before.
15945797|NCT03296852|Drug|Lumason|An IV line will be placed in a cubital or forearm vein. A bolus of 1.0ml of the ultrasound contrast agent (so called 'Microbubbles') Lumason™, internationally known as SonoVue (Bracco Pharmaceuticals, Italy), will be injected into the IV line, followed by a 5.0ml IV bolus injection of saline. Lumason™ has been FDA approved for cardiac applications to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. In the context of the present study Lumason™ would be used off-label.
15945798|NCT03296813|Drug|Torsemide|Loop diuretic
15945799|NCT03296813|Drug|Furosemide|Loop diuretic
15945800|NCT03296800|Drug|Bexagliflozin|Bexagliflozin 20 mg, tablet; qd
15945801|NCT03296800|Drug|Probenecid|Probenecid tablets, 500 mg; bid
15945802|NCT03296800|Drug|Rifampin|Rifampin, 600 mg (2 x 300 mg capsules); qd
15945803|NCT03296800|Drug|Verapamil|Verapamil hydrochloride tablet, 120 mg; qd
15945804|NCT03296787|Drug|TAK-954|TAK-954 intravenous infusion.
15945805|NCT03296774|Behavioral|Healthy Beyond Pregnancy|Web-based intervention grounded in behavioral economics and designed to improve adherence with postpartum care.
15945806|NCT03296774|Behavioral|Usual Care|
15945807|NCT03296748|Procedure|trans-obturator tape inside-out usingsoft tapes.|trans-obturator tape inside-out soft tapes is applied under spinal anesthesia. After the procedure, the vaginal gauze packing and Foley catheter were removed on the morning of the next day.
15945808|NCT03296748|Procedure|anterior colporraphy|
15945809|NCT03296735|Procedure|Ipsilateral tilt|The operation table will be tilted 20 degrees right laterally.
15945810|NCT03296735|Procedure|Contralateral tilt|The operation table will be tilted 20 degrees left laterally.
15945811|NCT03296722|Behavioral|The Transtheoretical Model|Intervention with the Transtheoretical Model, through group and individual sessions with topics of healthy eating habits taught by a dietician, physical activity and exercise manual taught by a physical therapist, preparation of healthy food with menu taught by graduates in gastronomy, confrontation of barriers given by a psychologist. This group had a monthly monitoring during 3 months. The food plan that was prescribed to the intervention group was with the characteristics of the DASH diet, according to the most recent international guides of the ACC and AHA, for the reduction of cardiovascular risk.
15945812|NCT03296709|Device|PPC z|Installation of a preformed pediatric zircona crown
15945813|NCT03296709|Device|PPC m|Installation of a preformed pediatric metal crown
15945814|NCT03296696|Drug|AMG 596|Drug
15945815|NCT03296696|Drug|AMG 404|Drug
15945816|NCT03296683|Device|MIRA device imaging|MIRA Device imaging for adjunctive detection of breast cancer
15945817|NCT03296670|Drug|Alprostadil|alprostadil,2ug, delivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients with CSFP
15945818|NCT03296670|Drug|Nitroglycerin|Nitroglycerin,200ug, delivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients with CSFP
15945819|NCT03296657|Drug|stannous fluoride|subjects will brush with paste twice daily for 2 weeks
15945820|NCT03296644|Device|Class II correction using PowerScope2|
15945821|NCT03296644|Device|Class II correction using Forsus|
15945822|NCT03296631|Other|collection of diapers with fresh stools|collection of diapers with fresh stools
15945823|NCT03296618|Drug|NSI-566|Dosing will consist of a one-time stereotactic, intracranial injection of a hNSC line, NSI-566, ranging from 1.2×107 cells to 8×107 cells, as tolerated.
15945824|NCT03296592|Diagnostic Test|MRI with DBSI technology|The MRI will be done with diffusion basis spectrum imaging
15945825|NCT03296579|Device|BiPAP|The patient's breathing is assisted by cycling between high and low pressures at a pre-set rate.
15945826|NCT03296579|Device|CPAP|The patient breathes against a constant pressure delivered by face mask.
15945827|NCT03296579|Drug|Ipratropium|Nebulized q6h
15945828|NCT03296579|Drug|Magnesium Sulfate|50mg/kg IV, 4 doses q6h
15945829|NCT03296579|Drug|Aminophylline|6mg/kg IV (if no progress)
15945830|NCT03296579|Drug|Standard steroid dose, hourly salbutamol, oxygen as needed|Standard common therapies for all three arms.
15945831|NCT03296566|Behavioral|Patient Liaison|An experienced colposcopy nurse will contact participants once the colposcopists complete the final colposcopy report. The colposcopy report will inform the referring provider that these patients will be informed of the results. The colposcopy nurse will provide an explanation of the colposcopy results and subsequent follow-up or treatment recommendations, be available to answer patient questions (within her scope), offer educational or support resources to patients. She will forward any patient questions beyond her scope to the patient's colposcopist who may then provide answers to the patient liaison or to the patient directly depending on the complexity and nature of the question.
15945832|NCT03296553|Drug|Valganciclovir|The experimental group will receive Valganciclovir 900 mg twice in a day before the initiation of cART until viral load of HHV-8 is undetectable.
15945833|NCT03296553|Drug|Antiretroviral Combinations|Patients will receive standard antiretroviral treatment as recommended
15945834|NCT03296540|Drug|Prasugrel (Crushed tablets)|loading dose of 6 crushed tablets 10mg Prasugrel
15945835|NCT03296540|Drug|Prasugrel (Integral tablets)|loading dose of 6 integral tablets of 10mg Prasugrel
15945836|NCT03296527|Drug|Follitropin alfa|GONAL-F dose was fixed for the first 5 stimulation days.
15945837|NCT03296527|Drug|Follitropin delta|REKOVELLE (FE 999049) was fixed throughout the stimulation period.
15945838|NCT03296514|Behavioral|MBSR|Eight week class on MBSR in addition to an orientation class and a half day retreat
15945839|NCT03296501|Biological|Cell-based therapy of autologous adipose derived regenerative cells transplanted intraspinally and intrathecally in ALS patients|3 injections of ADRC: 1 intraspinal and 2 intrathecal
15945840|NCT03296488|Drug|Nalbuphine Sebacate|intramuscular single dose of NALDEBAIN 24±12 hours before surgery.
15945841|NCT03296488|Drug|Fentanyl Citrate|Intravenous patient-controlled analgesia with fentanyl through 48 hours after surgery.
15945842|NCT03296475|Procedure|Abdominal Wall Closure Force (N).|This measurement will be recorded for both the right and left anterior rectus sheath. We will measure this force at three anatomical points 1) at the level of the umbilicus and 2) at the halfway point between the pubic symphysis and the xiphisternum and 3) at the point of maximal hernia defect width.
15945843|NCT03296462|Other|Hip external rotation exercise|Standardised HER exercise training by physiotherapist (plus video recording of exercises)
15945844|NCT03296462|Other|Pelvic floor muscle exercise|Standardised PFM exercise training by physiotherapist (plus video recording of exercises)
15945845|NCT03296449|Procedure|CPAP|A recruitment maneuver will be applied to the ventilated lung. Immediately continuous positive airway pressure, at a pressure of 2-3cmH2O will applied to the non-ventilated lung for 20 minutes by the Mallinckrodt Bronchocath Disposable CPAP system (a recognised anesthetic breathing system design for CPAP).
15945846|NCT03296449|Procedure|HFJV|A recruitment maneuver will be applied to the ventilated lung. Immediately, high-frequency jet ventilation, with a driving pressure of 0.5 atm and a respiratory rate of 100 cycles per minute will applied to the non-ventilated lung for 20 minutes using the Monsoone III Jet Ventilator (Acutronic, Hirzel, Switzerland). Monsoone III is a recognised ventilator design for HFJV.
15945847|NCT03296436|Biological|NEOX® CORD 1K®|NEOX CORD 1K is a cryopreserved human umbilical cord product derived from donated human placental tissue following healthy, live, caesarian section, full-term births after determination of donor eligibility and placenta suitability. NEOX CORD 1K is manufactured by TissueTech Inc. utilizing a proprietary CRYOTEK® process, which devitalizes the living cells but retains the natural structural and biological characteristics relevant to this tissue. NEOX CORD 1K is aseptically processed in compliance with current Good Tissue Practices (cGTP). NEOX CORD 1K of various sizes is stored in a medium of Dulbecco's Modified Eagle Medium/Glycerol (1:1) containing Amphotericin B (an anti-fungal agent). NEOX CORD 1K will be applied to completely cover the wound area and is maintained stationary with sutures or even negative pressure wound therapy after adequate sharp debridement.
15945848|NCT03296423|Biological|Vaccination|Patients discharged from hospital will be vaccinated with one intradermal injection of 0.1ml of BCG vaccine
15945849|NCT03296423|Biological|Placebo|Patients discharged from hospital will be vaccinated with one intradermal injection of 0.1ml of sodium chloride 0.9%
15945850|NCT03296410|Biological|EV71 and two measles attenuated live vaccine|infants vaccined with two dose (3.0 EU/dose) of inactivated enterovirus 71 vaccine (KMB-17) at 8 months old and 9 months old (namely interval one month). And meanwhile, they routine vaccined with two measles attenuated live vaccine at 8 months old.
15945851|NCT03296410|Biological|EV71 and attenuated Japanese encephalitis vaccine|infants vaccined with two dose (3.0 EU/dose) of inactivated enterovirus 71 vaccine (KMB-17) at 8 months old and 9 months old (namely interval one month). And meanwhile, they routine vaccined with attenuated Japanese encephalitis vaccine at 8 months old.
15945852|NCT03296410|Biological|two measles attenuated live vaccine|infants vaccined with one dose two measles attenuated live vaccine at 8 months old.
15945853|NCT03296410|Biological|live attenuated Japanese encephalitis vaccine|infants vaccined with one dose attenuated Japanese encephalitis vaccine at 8 months old.
15945854|NCT03296410|Biological|EV71 vaccine|infants vaccined with two dose (3.0 EU/dose) of inactivated enterovirus 71 vaccine (KMB-17) at 8 months old and 9 months old (namely interval one month).
15945855|NCT03296397|Biological|Vaccination with Gardasil|Vaccination with Gardasil in patients apparently cured of external genital warts
15945856|NCT03296397|Biological|Injection of Normal Saline|Injection of Normal Saline in patients apparently cured of external genital warts
15945857|NCT03296384|Other|Clinical and environmental evaluation|For schizophrenic's patients, specific assessment will be perform
15945858|NCT03296371|Procedure|Biospecimen Collection|Undergo saliva or buccal mucosa collection
15945859|NCT03296371|Other|Laboratory Biomarker Analysis|Correlative studies
15945860|NCT03296371|Other|Questionnaire Administration|Ancillary studies
15945861|NCT03296358|Drug|IV Dexamethasone|The patients would be random into 3 groups. The randomization process would already be prepared into 3 groups with a number coding by the statistician who doesn't get involve in the rest of experiment. The drugs would be in the 3 group of sealed envelopes which have 3 kinds of drug combination After the envelopes are sealed, it will be code in an order of number. Experiment 1 and Experiment 2 groups would receive IV Dexamethasone in emergency department (ED).
15945862|NCT03296358|Drug|Oral prednisolone|The patients would be random into 3 groups. The randomization process would already be prepared into 3 groups with a number coding by the statistician who doesn't get involve in the rest of experiment. The drugs would be in the 3 group of sealed envelopes which have 3 kinds of drug combination After the envelopes are sealed, it will be code in an order of number. Experiment 2 groups would receive IV Dexamethasone in ED and Oral prednisolone as home medication.
15945863|NCT03296345|Drug|Ketamine|The intervention is IV low-dose bolus ketamine as an adjuvant to standard therapy (IV opiates and NSAIDs).
15945864|NCT03296319|Device|Echocardiography|Echocardiography guided fluid administration
15946194|NCT03293706|Other|CHO Experimental 2 Digestion Resistant|mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption
15945865|NCT03296306|Drug|Treatment duration of cisplatin based chemotherapy|"GP regimen: Gemcitabine (1000 mg/m2 D1, D8), Cisplatin (60 mg/m2 D1), every 3 weeks
~GP-S regimen: Gemcitabine (1000 mg/m2 D1, D8), Cisplatin (35 mg/m2 D1,D 2 or D8), every 3 weeks
~MVAC regimen: Methotrexate (30 mg/m2 IV bolus, D1, 15, 22), Vinblastine (3 mg/m2 IV bolus, D2, 15, 22), Doxorubicin (30 mg/m2 IV bolus D2), Cisplatin (70 mg/m2 D2), every 4 weeks
~HD-MVAC with GCSF regimen: Methotrexate (30 mg/m2 IV bolus, D1), Vinblastine (3 mg/m2 IV bolus, D2), Doxorubicin (30 mg/m2 IV bolus D2), Cisplatin (70 mg/m2 D2), G-CSF (240 ug/m2 SC, D4-10), every 2 weeks"
15945866|NCT03296293|Other|PEEP at 5cmH2O|Effect of PEEP at 5cmH2O on ICP
15945867|NCT03296293|Other|PEEP at 10cmH2O|Effect of PEEP at 10cmH2O on ICP
15945868|NCT03296293|Other|PEEP at 15cmH2O|Effect of PEEP at 15cmH2O on ICP
15945869|NCT03296267|Procedure|Gastroduodenoscopy|Gastroduodenoscopy with duodenal biospies: A tube is placed via the mouth into the second part of the duodenum. Biopsy forceps is used to take duodenal biopsies.
15945870|NCT03296254|Behavioral|Sitting Mindfulness Exercises.|5 weekly sessions of 2,5 hours/session of Sitting Mindfulness Meditation
15945871|NCT03296254|Behavioral|Body Mindfulness Exercises|5 weekly sessions of 2,5 hours/session of Body Scan and Mindful Movements
15945872|NCT03296241|Device|laser|
15945873|NCT03296241|Device|sham control|
15945874|NCT03296228|Radiation|Flexibility Radiographs (supine, supine side-bend, FB)|Supine, supine side-bend, fulcrum bend
15945875|NCT03296228|Radiation|Flexibility Radiographs (awake traction)|awake traction
15945876|NCT03296228|Radiation|Flexibility Radiographs (STUGA)|supine traction under GA
15945877|NCT03296215|Other|Observational|To determine different patterns of admission and their Outcome
15945878|NCT03296189|Drug|Levobupivacaine|intraluminal injection post procedure for pain relief: alkalinised high concentration 10 mls
15945879|NCT03296189|Drug|Dexamethasone Sodium Phosphate|intraluminal injection post procedure for pain relief: alkalinised high concentration 10 mls levobupivicaine and 2mls dexamethasone
15945880|NCT03296189|Drug|Placebos|10 mls normal saline
15945881|NCT03296176|Biological|blood sample|blood sample for metabolome analyse
15945882|NCT03296163|Drug|MB02 (Bevacizumab Biosimilar Drug)|15 mg/kg IV every 3 weeks on Day 1
15945883|NCT03296163|Drug|EU-approved Avastin®|15 mg/kg IV every 3 weeks on Day 1
15945884|NCT03296163|Drug|Carboplatin|Carboplatin Area under the curve (AUC) 6 IV every 3 weeks on Day 1 for 6 cycles
15945885|NCT03296163|Drug|Paclitaxel|Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 6 cycles
15945886|NCT03296150|Behavioral|PRESTAGE|PRESTAGE educational program targets the acquisition by the patients and their caregivers of competencies in (1) a better understanding of their disease and (2) their treatment, (3) a better drug management, including both anticancer and supportive treatments, (4) maintenance of a good nutritional status, (5) general health and psychological well being and (6) physical well being. After an individual educational diagnosis, each patient will be proposed an individualized educational program consisting in 1 to 6 of these workshops. An individualized final interview - entitled educational synthesis - will assess patient's skills and satisfaction.
15945887|NCT03296137|Biological|Autologous tumor-infiltrating lymphocytes|Tumor-infiltrating lymphocytes grown ex-vivo from resected from cancer tissue and reapplied to the patient via an intravenous infusion.
15945888|NCT03296137|Drug|Ipilimumab|One treatment with ipilimumab (3 mg/kg) prior to tumor resection.
15945889|NCT03296137|Drug|Nivolumab|4 doses of nivolumab. Starting 2 days prior to TIL infusion and every 2 weeks hereafter.
15945890|NCT03296137|Drug|proleukin|2 MIE s.c. injection, after TIL infusion and continuing for 2 weeks
15945891|NCT03296137|Drug|Cyclophosphamide|2 doses (60 mg/kg) prior to TIL infusion
15945892|NCT03296137|Drug|Fludara|5 doses (25 mg/m2) prior to TIL infusion
15945893|NCT03296111|Other|Questionnaires on pain and quality of life|"Patients will be asked to complete several questionnaires about their pain and the impact on their quality of life.
~They will complete the questionnaires in the ophthalmology consultation room or at home and return it by mail (or present it at the next consultation).
~Patients will be asked to complete several questionnaires :
~Questionnaire about the characteristics of ocular neuropathic pain (7 items)
~DEQ-5 (Dry Eye Questionnaire)
~ODI (Ocular Surface Disease Index)
~BPI (Brief Pain Inventory)
~HADS (Hospital Anxiety and Depression Scale)"
15945894|NCT03296098|Drug|Ulipristal acetate|Ulipristal aceteate 5 mg oral tablets to take two tablets daily.
15945895|NCT03296085|Procedure|Exam for quantity of edema|There is no intervention
15945896|NCT03296072|Drug|0.254% w/w sodium fluoride and 5% KNO3|Dentifrice containing 0.254% w/w sodium fluoride (1150 ppm fluoride) and 5% KNO3; plus 0.25% PVM/MA copolymer and 2.5% sodium lactate. Participants will brush it on the buccal surfaces of their natural teeth for 25 timed seconds and then swish the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants will gently rinse their mouths with 15 millilitres [mL] of tap water for 10 seconds before expectorating again.
15945897|NCT03296072|Drug|0.454% w/w stannous fluoride|Dentifrice containing 0.454% w/w stannous fluoride (1100 ppm fluoride). Participants will brush it on the buccal surfaces of their natural teeth for 25 timed seconds and then swish the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants will gently rinse their mouths with 15 mL of tap water for 10 seconds before expectorating again.
15945898|NCT03296072|Drug|5% KNO3|Fluoride free placebo dentifrice containing 5% KNO3 (0 ppm fluoride), 0.25% PVM/MA copolymer and 2.5% lactate. Participants will brush it on the buccal surfaces of their natural teeth for 25 timed seconds and then swish the resulting toothpaste slurry around the mouth, without further brushing, for a timed period of 95 seconds. After expectorating the slurry, the participants will gently rinse their mouths with 15 mL of tap water for 10 seconds before expectorating again.
15945899|NCT03296059|Other|conventional treatment with RBC transfusion|Besides conventional treatment, neonates is given RBC transfusion.
15945900|NCT03296059|Other|conventional treatment|neonates is treated with conventional treatment.
15945901|NCT03296046|Biological|Blood test|30 ml
15945902|NCT03296033|Drug|Enoxaparin|The intervention is the implementation of a 36-hour time period from the last dose of treatment dose Enoxaparin to the blood sampling for anti-Xa testing.
15946611|NCT03290417|Dietary Supplement|Vitamin D|5000 IU/cap; One cap by mouth daily
15945903|NCT03296033|Drug|Enoxaparin|This is the historical control arm. 24 hours removed from their last dose (time period from the last dose of treatment dose Enoxaparin to the blood sampling for anti-Xa testing)
15945904|NCT03296020|Other|HONEY|100% Natural pure Honey, produced by EIN HAROD CO-OPERATIVE, ISRAEL
15945905|NCT03296007|Behavioral|Mindfulness Meditation|A meditative practice involving paying attention to present moment experiences and focusing on breathing sensations.
15945906|NCT03295994|Procedure|Operative|Arthroscopic rotator cuff surgery followed by physical therapy.
15945907|NCT03295994|Procedure|Non-Operative|Physical therapy (without surgery).
15945909|NCT03295968|Other|High Intensity Exercise/Ibuprofen|HIEX, with and without the inflammation inhibitor, ibuprofen, on plasma levels of IL-6 and other selective biomarkers of inflammation and appetite on food intake and subjective ratings of appetite in normal-weight boys.
15945910|NCT03295955|Drug|Amoxicillin Clavulanate|"Per-oral Amoxicillin Clavulanate Given or Non-given, after surgery"
15945911|NCT03295942|Drug|OMP-336B11|OMP-336B11 is an engineered human protein that was designed to bind to the GITR receptor on T cells and activate the immune system to recognize and eliminate cancer cells.
15945912|NCT03295916|Radiation|Stereotactic Body Radiotherapy|Five fraction SBRT (or two fraction in case of spine) to any sites of breast cancer oligometastasis using robotic radio surgery or linear accelerator based SBRT
15945913|NCT03295903|Dietary Supplement|Cannabidiol supplement|Subjects will be administered in a double-blinded, randomized and cross-over design
15945914|NCT03295890|Procedure|Dry Needing|Dry Needling
15945915|NCT03295877|Drug|RO7171009|Patients will receive RO7171009 via ITV injection.
15945916|NCT03295864|Diagnostic Test|Multifrequency tympanometry at Inclusion|Multifrequency tympanometry measurement and particularly width of conductance tympanograms at 2 kHz will be performed for both group at inclusion
15945917|NCT03295864|Diagnostic Test|Multifrequency tympanometry 6 month after surgery|Multifrequency tympanometry measurement and particularly width of conductance tympanograms at 2 kHz will be performed 6 months after surgery for Chiari type I malformation patient
15945918|NCT03295851|Drug|Ferric carboxymaltose|Patients in the intervention group will receive preoperative IV ferric carboxymaltose, given as a single dose (15 mg/kg body weight, to a maximum dose of 1000 mg) over 30 minutes.
15945919|NCT03295851|Drug|Ferrous Fumarate|Patients will be given oral iron as per current clinical protocol, which is Ferrous fumarate 200mg twice daily.
15945920|NCT03295838|Behavioral|Mentalization-based treatment|See Arm description
15945921|NCT03295825|Diagnostic Test|Biomarker|Measument of heparin-binding protein in the serum of patients
15945922|NCT03295812|Other|standard therapy|standard therapy,non-interventional study
15945923|NCT03295799|Other|Patient Self-Management|Patient will manage their own warfarin therapy.
15945924|NCT03295786|Drug|Cerebral Dopamine Neurotrophic Factor|Repeated intracerebral infusions
15945925|NCT03295786|Device|Renishaw Drug Delivery System|Stereotactically implanted device
15945926|NCT03295773|Diagnostic Test|3DRA|
15945927|NCT03295760|Drug|Q10 Coenzyme|
15945928|NCT03295747|Drug|Peppermint oil|Three doses of peppermint oil will be investigated: 180, 360, 540 mg.
15945929|NCT03295734|Behavioral|Aerobic exercise|Twice weekly centered based aerobic exercise + 3/week home-based walking
15945930|NCT03295734|Drug|Perindopril|4 mg qd titrated to 8 mg qd perindopril
15945931|NCT03295734|Drug|Losartan|50 mg qd titrated to 100 qd losartan
15945932|NCT03295734|Drug|HCTZ|12.5 mg qd titrated to 25 qd HCTZ
15945938|NCT03295708|Dietary Supplement|fish oil capsule|N-3 PUFAs is a kind of essential fatty acid,however the formation is too slow. Studies show that intakes of N-3 PUFAs is associated with MDD.It have to be got from food like deep-sea fishes. EPA and DHA are crucial for the body.Although studies have shown that reduced N-3 PUFAs were correlated with MDD, and patients with an elevated rate of N-6 PUFAs /N-3 PUFAs or a low level of DHA may be at higher odds for suicide. Trials on whether N-3 PUFAs is effective in the treatment of MDD is still controversial, which might be affected by several factors, such as dose, duration etc.. Now there is no large-scale randomized controlled clinical trial in determining the effects of N-3 PUFAs add-on in treatment of MDD.
15945939|NCT03295708|Dietary Supplement|soybean oil capsule|placebo capsule
15945940|NCT03295695|Diagnostic Test|Fluoro-D-glucose-positron Emission Tomography|2-deoxy-2-[18F]Fluoro-D-glucose-positron Emission Tomography (FDG-PET): within 2 weeks of obtaining first echocardiogram; within two weeks of obtaining follow-up echocardiogram.
15945941|NCT03295695|Biological|2-deoxy-2-[18F]fluoro-D-glucose (FDG)|"2-deoxy-2-[18F]fluoro-D-glucose (FDG) labeled autologous human erythrocytes (RBCs): Approximately 10 mls of packed human erythrocytes are collected from the patient and labeled with ≈5-10 milliCuries of commercially available United States Pharmacopeia (USP)-grade FDG (≈5-10 picograms FDG) (Vendor: Cardinal Health) under sterile conditions in a Good Manufacturing Practice (GMP)-certified laboratory.
~Synthesized RBCs: The cell suspension is manually infused via syringe through an indwelling peripheral venous catheter over the course of 1 minute, using an infusion method approved by the Moffitt Cancer Center (MCC) radiation safety officer."
15945942|NCT03295695|Diagnostic Test|Echocardiogram|Echocardiogram: prior to start of chemotherapy; post-treatment regimen.
15945943|NCT03295682|Device|Endovascular thoracoabdominal aneurysm repair|Endovascular treatment of patients with thoracoabdominal aneurysm using a multibranch stent graft tailored to the patient´s anatomy in combination with peripheral covered stents to bridge the visceral arteries
15945944|NCT03295656|Drug|Sulfur hexafluoride lipid-type A microspheres|Contrast-enhanced US imaging of the appendix
15945945|NCT03295643|Device|Mobile smoking cessation program and CO breath sensor device|Mobile smoking cessation program delivered through an app with access to a breath sensor device and coaching support.
15946195|NCT03293706|Other|CHO Experimental 3 Low Sugar|mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption
15945946|NCT03295630|Device|Accelerometer|Participants will perform a semi-structured movement protocol to investigate the ability of the Actigraph GT3X accelerometer to identify body position (lying, sitting or standing) and quantify step count.
15945947|NCT03295617|Procedure|Thoracoscopy|Thoracoscopy surgery
15945948|NCT03295604|Procedure|SCTG+EMD|Miller class I-II gingival recession defects were operated with SCTG+EMD
15945949|NCT03295604|Procedure|SCTG|Miller class I-II gingival recession defects were operated with SCTG only and
15945950|NCT03295591|Diagnostic Test|Circulating tumor cell|Circulating tumor cell enumeration and sequencing
15945951|NCT03295578|Other|Personalized feedback|"The personalized feedback report will contain a general explanation about glucose, cognition and wellbeing, healthy cut-offs and/or benchmark values, and why these measures are relevant for personal health and wellbeing. Also, a general explanation will be given about how glucose levels can be influenced.
~Also, the personalized feedback will contain the individual glucose response profiles, as well as graphs showing the wellbeing scores over time. The registered food intake will be mapped and linked to the glucose and wellbeing profiles. The results of the wellbeing questionnaire will also be shown and will be linked to the individual profiles and food intake."
15945952|NCT03295578|Other|Generic feedback|The generic feedback will contain a generic explanation about glucose, cognition wellbeing and food intake and their relationship. The generic feedback will not include personal results.
15945953|NCT03295578|Device|Continuous glucose monitoring device|This is not an intervention, but a measurement device used during the study. Added here as intervention to avoid errors in the system.
15945954|NCT03295565|Drug|Cabazitaxel|Cabazitaxel 25mg/m2 IV, once every 3 weeks
15945955|NCT03295565|Drug|Abiraterone|Abiraterone 1000mg oral, taken daily + Prednisone 5mg oral, 2 times a day
15945956|NCT03295565|Drug|Enzalutamide|Enzalutamide 160mg oral taken daily
15945957|NCT03295552|Drug|Decitabine|decitabine 7mg/m2, d1-d5, q3w
15945958|NCT03295552|Drug|Carboplatin|carboplatin AUC = 6, d6, q3w
15945959|NCT03295539|Device|'Indigo' Mechanical thrombectomy system|"Removal of acute clot from the artery causing ischaemia, using the mechanical aspiration system by Penumbra Inc called INDIGO"
15945960|NCT03295526|Procedure|Lymph nodes debulking surgery.|Radical hysterectomy and selective enlarged lymph node dissection
15945961|NCT03295513|Other|Veneered zirconia|he use of veneered zirconia is well documented in the literatures as successful restoration modality. A two Clinical performance of two different CAD/CAM-fabricated ceramic crowns revealed no chipping for veneered zirconia
15945962|NCT03295513|Other|Monolithic zirconia|Monolithic zirconia product presented a new generation of polycrystalline material by which full anatomical crowns and bridges can be produced
15945964|NCT03295487|Procedure|TVT-O|transobturator tape has been applied to all the patients in the study,and local estrogen vaginal cream is only applied to patients in group A
15945965|NCT03295474|Other|Rehabilitation using telehealth technology|"Consecutive patients with chronic respiratory disease referred for pulmonary rehabilitation are offered to participate in the protocol.
~Patients are taught to use the system during the first session of aerobic training.
~During 2 to 5 sessions of aerobic training (depending on the number of sessions needed to be autonomous), they are monitored in the pulmonary rehabilitation center with an oximeter device (Nonin 3150).
~At the end of every session, patients are asked to answer to 3 questions on a Likert scale (see outcome session).
~The therapist also ascertains wether the telemonitoring gateway successfully provided informations regarding the session.
~The study takes off on the session during which the patients are autonomous in using the telehealthcare system.
~If patients are not autonomous on the fifth session, the study also takes off."
15945966|NCT03295461|Procedure|SRP+ 10% Emblica officinalis irrigation|
15945967|NCT03295461|Procedure|SRP + 0.2% Chlorhexidine irrigation)|
15945968|NCT03295461|Procedure|SRP + 0.9% Saline irrigation|
15945969|NCT03295461|Procedure|SRP +10% E. officinalis gel application.|
15945970|NCT03295461|Procedure|SRP+ placebo gel application.|
15945971|NCT03295448|Other|Low carbohydrate diet|Diet low in carbohydrates (38%E), but higher in total and saturated fat.
15945972|NCT03295448|Other|High carbohydrate, high sugar diet|Diet high in carbohydrates (53%E) and sugars, but low in wholegrain, rye and wheat fibre.
15945973|NCT03295448|Other|High carbohydrate, low sugar diet|Diet high in carbohydrates (53%E), wholegrain, rye and wheat fibre, but low in sugars.
15945974|NCT03295435|Other|Composition of functional tooth units|"Composition of functional tooth units measured by trained oral health therapists and was categorised into 3 groups:
~Group A: Natural units only Group B: Natural & Prosthetic units present Group C: No natural units present"
15945975|NCT03295422|Procedure|RF ablation PVI alone|A series of RF applications will be delivered around both sets of pulmonary veins with complete entry and exit block obtained around the antrums of all 4 pulmonary veins.
15945976|NCT03295422|Procedure|RF ablation PVI plus LPAW|A series of RF applications will be delivered around both sets of pulmonary veins with complete entry and exit block obtained around the antrums of all 4 pulmonary veins. In addition, a roof and posterior line will be placed in the left atrium to achieve entrance and exit block on the posterior wall. Entry block will be confirmed by placing a circular mapping catheter in multiple locations along the posterior wall and confirming lack of presence of any local potentials. Exit block will be confirmed on the posterior wall with pacing at 10 amps from the ablation catheter at multiple locations within the box as well as all lines.
15945977|NCT03295409|Behavioral|Self-affirmation|Participants are asked to complete a standard questionnaire and on the last page they are asked to form a self-affirming implementation intention by copying out a sentence.
15945978|NCT03295396|Drug|ONC201|ONC201 is an oral, small molecule selective antagonist of DRD2 that induces tumor cell death.
15945979|NCT03295383|Drug|Rituximab 1g IV|Rituximab at a dose of 1000 mg will be administered by IV infusion on Day 1 and Day 15 whatever the patient's weight, with repeat maintenance rituximab (or matching placebo) administration on Day 182 and Day 197
15946612|NCT03290417|Dietary Supplement|Omega-3|720 mg/cap; one capsule by mouth 3 times per day
15945980|NCT03295383|Drug|Cyclophosphamide 50Mg Oral Tablet|"cyclophosphamide will be administered orally once daily at the following initial doses:
~patients younger than 75 years: 1.5 mg/kg/day, orally.
~patients older than 75 years: 1 mg/kg/day, orally."
15945981|NCT03295383|Drug|Placebo of Rituximab|Rituximab placebo will be administered by IV infusion on Day 1 and Day 15 whatever the patient's weight, with repeat maintenance rituximab administration on Day 182 and Day 197
15945982|NCT03295383|Drug|Placebo Oral Tablet|cyclophosphamide placebo will be administered orally once daily
15945983|NCT03295370|Procedure|Electrical Stimulation|A needle is placed near accessory spinal nerve; electrical burst stimulation for 12 minutes, 10 Hz;
15945984|NCT03295344|Other|Diaphragm ultrasonography|"Spontaneously breathing patients in the ½ seated position Heart transducer at the medio axillary position, parallel to the axis of the body, last intervertebral spaces
~US mode:
~2D = Evaluation of the pulmonary parenchyma Time-Movement (TM) = Evaluation of diaphragm muscle shortening in the apposition zone + Evaluation of diaphragm mobility in the posterior 1/3 of the diaphragm dome Tissue Doppler Imaging (TDI) = Evaluation of diaphragm mobility in the diaphragm dome Collection of different daily clinical data"
15945985|NCT03295344|Other|Tissue Doppler|Determine the threshold value for diaphragm mobility
15945986|NCT03295318|Biological|Non-adjuvanted study formulation NmCV-5|Non-adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine.
15945987|NCT03295318|Biological|Adjuvanted study formulation NmCV-5|Adjuvanted formulation of polyvalent conjugate meningococcal vaccine against serogroups A,C,Y,W&X (NmCV-5) is available as lyophilised powder of polysacchride antigens A&X conjugated to tetanus toxoid and C,Y&W conjugated to CRM protein. The diluent contains Alum as adjuvant with Normal Saline. Each antigen content is 5 micrograms per 0.5 mL dose of vaccine
15945988|NCT03295318|Biological|Menactra|Menactra is available as ready to used solution containing polysacchride antigens A,C,Y&WX conjugated to diphtheria toxoid. Each antigen content is 4 micrograms per 0.5 mL dose of vaccine.
15945989|NCT03295305|Behavioral|Action-Based Cognitive Remediation|
15945990|NCT03295305|Behavioral|Unstructured support group|
15945991|NCT03295292|Biological|Stem cells|Mixture of limbus derived corneal epithelial cells and limbus derived corneal stromal cells in a ratio of 2:1, at a concentration of 50000 cells/uL diluted in fibrin sealant
15945992|NCT03295292|Other|Vehicle|50uL of commercially available fibrin sealant (Baxter, TISEEL)
15945993|NCT03295266|Drug|MK-3866|Single IV infusion of MK-3866 150 mg administered over 30 minutes at Hour 0 on Day 1 of treatment period.
15945994|NCT03295253|Procedure|Autologous adipose tissue harvesting/grafting using Lipogems|Adipose tissue harvesting and grafting in the urethra using fat micro-fragmentation and processing device Lipogems
15945995|NCT03295240|Drug|BR-I (bendamustine, rituximab, ibrutinib)|The BR-I (bendamustine, rituximab, ibrutinib) regimen will be administered for six 28-day cycles: bendamustine (90 mg/m2; (or 70mg/m2 for dose level -1); day 1 and 2 ), rituximab (375 mg/m2; day 1), and ibrutinib one pill or four 140mg capsules (560 mg oral daily; day 1-28).
15945996|NCT03295240|Drug|VEN (Venetoclax)|The initial cycle 1 VEN (Venetoclax) dose ramp-up will be: 20 mg daily for 1 week, 50 mg daily for week 2, 100 mg daily for week 3, and 200 mg daily for week 4. Thereafter, VEN will be administered at a fixed dose level of 400 mg daily for varying durations of each 28-day cycle. Now also include a -2 dose level which has the reduced 3-day duration of Ventoclax 400 mg daily.
15945997|NCT03295227|Drug|Pembrolizumab|"Part 1: 200 mg by vein on Day 1 of every 21 day cycle.
~Part 2: Maximum tolerated dose from Part 1."
15945998|NCT03295214|Drug|Acetaminophen|Acetaminophen given for pain relief
15945999|NCT03295201|Other|Active cycle of breathing techniques (ACBT)|ACBT involves three phases (Breathing control, chest expansion exercise, and huff coughing). These phases will apply with a sequence to remove secretion. ACBT will apply 1 per a week for 6 weeks.
15946000|NCT03295201|Other|Postural Exercise|Postural exercise program will include thoracic vertebra mobilization, pectoral stretching, scapula and thoracic extensors strengthening and core stability exercises. Postural exercise program will apply 1 per a week for 6 weeks.
15946001|NCT03295188|Dietary Supplement|Plasmalogen|Treatment group takes two 0.5 mg plasmalogen capsules per day for 12 weeks.
15946002|NCT03295188|Dietary Supplement|Placebo|Placebo Group takes two placebo capsules per day for 12 weeks.
15946003|NCT03295175|Diagnostic Test|Hematoxylin-eosin and smooth muscle actin markers|"The foreskin arrives oriented in a single piece in formol to the unit of pathology, and in the pathology unit, they must:
~Measure the length, width and thickness of the specimen. The specimen should include skin and mucosa with the underlying areolar tissue.
~Examine the surfaces of the sample searching lesions, and describe them in size, appearance (warty, papillary, ulcerated), depth of invasion, and distance from the nearest cutting edge, if they are present."
15946004|NCT03295162|Drug|Melatonin 10 mg|Melatonin will be given at a total dose of 20 mg dissolved in 4 ml of distilled water via enteral route in two doses of 10 mg each(2 ml ), with a 1-hour interval. to one group together with conventional treatment
15946005|NCT03295162|Combination Product|Conventional treatment of neonatal sepsis|Conventional treatment of neonatal sepsis including antibiotics,IV fluids, Total Parenteral Nutrition,etc...
15946006|NCT03295136|Behavioral|Health Promotion Training for Women Employees|Group intervention over a one year, acquiring health promotion tools and skills, as well as leadership and project designing and implementation skills.
15946007|NCT03295123|Other|phone interview with the mother|it's a telephone survey about children's health
15946008|NCT03295110|Other|Functionalities of the Lili Smart Solution activated|Non-medical connected device (Lili Smart solution) activated : application for caregivers (web / mobile), GSM watch worn by the patient, smart sensors placed at different locations of the patient's home and a support service 24 /24 and 7/7.
15946009|NCT03295110|Other|Functionalities of the Lili Smart Solution non activated|Non-medical connected device (Lili Smart solution) with inactive functionalities : watch worn by the participants and sensors placed at home with their functionalities inactivated. Absence of the web / mobile application.
15946071|NCT03294590|Other|CWT Parent targeted text messages|For the CWT group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to child wellness.
15946010|NCT03295097|Other|Clinical Decision Support System|The system provides clinicians with patient-specific genetic information on opioid responsiveness and multi-drug interactions. This clinical decision support system should improve the clinician's ability to identify the optimal pain medication and dosage, and reduce risks associated with multi-drug treatment.
15946011|NCT03295084|Drug|Irinotecan|Dose Escalation
15946012|NCT03295084|Drug|Capecitabine|Dose Escalation
15946013|NCT03295071|Other|Patient-reported outcomes (PROs)|Patient-reported outcomes (PROs)
15946014|NCT03295058|Drug|Non ATG Conditioning regimen|50% of the patients will receive Fludarabine + cyclophosphamide (F-araA 120 mg/m2 total dose for 3 days (d-3,-2,-1) over 1 h infusion and cyclophosphamide 25 mg/kg/d (d-5 to d-2) for 4 days over 1-h infusion prior to hematopoietic cell transplantation , then post transplant cyclophosphamide dose 50 mg/kg on days +3 and +4
15946015|NCT03295058|Drug|GVHD Prophylaxis|Cyclosporine A (CsA 3 mg/kg) start day +5
15946016|NCT03295058|Procedure|Allogenic Stem Cell Transplantation|using peripheral blood stem cells
15946017|NCT03295058|Drug|ATG conditioning regimen|the other 50% of the patients will receive Cyclophosphamide + ATG
15946018|NCT03295032|Behavioral|Acceptance and Commitment Therapy (ACT)|"ACT is a psychological intervention; in this study it is being delivered as a 4-week psycho-educational group to stroke survivors and carers.
~Rather than attempting to control or ameliorate pain and suffering, ACT advocates that individuals remain open to internal private experiences (both positive and negative) and should focus on committing to a life which is congruent with their core values. Individuals learn to modify their relationship with these experiences, rather than change the experiences per se through processes such as mindfulness, acceptance and attention to values. This fundamental premise of ACT helps cultivate psychological flexibility."
15946019|NCT03295019|Device|Test Oral Spray|HA formulation of FDA listed ingredients
15946020|NCT03295019|Device|Placebo Oral Spray|Placebo formulation without the active ingredients
15946021|NCT03295006|Device|TheraSphere|Patients who had received TheraSphere
15946022|NCT03294993|Device|Ultrasound assess|The investigators designed a study to assess whether there were any blood flow indexes change before and after radial artery puncture with doppler ultrasonography
15946023|NCT03294967|Dietary Supplement|Caffeine|As in group descriptions
15946024|NCT03294967|Dietary Supplement|Vitamin E|As in group descriptions
15946025|NCT03294954|Genetic|GINAKIT Cells|"Four dose levels of GINAKIT cells will be studied. Dosing will be based on the actual number of transduced cells. All doses are per m2.
~Dose Level 1 = 3 x 10^6
~Dose Level 2 = 1 x 10^7
~Dose Level 3 = 3 x 10^7
~Dose Level 4 = 1 x 10^8"
15946026|NCT03294954|Drug|Cyclophosphamide|Cyclophosphamide (500 mg/m2/day) will be given for 2 days; given on day -4 and day -3 with GINAKIT cells given on day 0.
15946027|NCT03294954|Drug|Fludarabine|Fludarabine (30 mg/m2/day) will be given for 3 days; given on day -4, day -3 and day -2 with GINAKIT cells given on day 0.
15946028|NCT03294941|Combination Product|HepQuant SHUNT Liver Diagnostic Kit|Serial testing over 48 weeks
15946029|NCT03294928|Other|progressive increasing of PEEP level.|"four-step measurements of central artery blood pressure evaluating contour wave analysis during a progressive increasing of PEEP level First step (Baseline) Subjects spontaneously breathe in air at atmospheric pressure during applanation tonometry.
~Second step (PEEP=5 cm H2O) Applanation tonometry was performed during the application of PEEP = 5 cmH2O (Oxygen flow = 8lt.- Air flow = 10 lt.).
~Third step (PEEP= 10 cm H2O) Applanation tonometry was performed during the application of PEEP = 10 cmH2O (Oxygen flow = 15lt.- Air flow = 20 lt.).
~Fourth step (Recovery) Subjects spontaneously rebreathe air at atmospheric pressure during applanation tonometry."
15946030|NCT03294915|Dietary Supplement|Resistant Starch|Addition of 42g per day of green banana flour (10g / day resistant starch) to the usual diet of study participants
15946031|NCT03294915|Dietary Supplement|Placebo|Addition of 42g per day of mixture of guar gum, maltodextrin and cellulose to the usual diet of study participants
15946032|NCT03294902|Device|Pedra Tissue Perfusion Monitor|This study is a prospective single-centre, device observational study designed to enroll up to 60 evaluable subjects at 1 investigational site in the United Kingdom. Eligible subjects, who meet the requirements for one of the 3 distinct subject groups: (1) Critical Limb Ischaemia group, (2) Peripheral artery disease with superficial femoral arterial (SFA) or popliteal artery disease and (3) PAD-free group. Subjects who meet study eligibility criteria will be enrolled consecutively until the total number of subjects is enrolled per each group as outlined in the protocol. All subjects at the investigational site will be enrolled in the presence of a member of the Sponsor or selected designee in order to assist with the device operation and to verify that all protocol assessments are completed appropriately at baseline.
15946033|NCT03294889|Radiation|Stereotactic body radition (SBRT)|"Ultra-hypofractionated single-fraction SBRT with urethra-sparing with image-guidance and intra-fractional control motion with the Calypso® system.
~19 Gy in a single fraction to the whole prostate gland ± proximal seminal vesicles
~17 Gy in a single fraction to the urethra planning-risk volume (PRV)"
15946034|NCT03294863|Device|Embrace Scar Therapy Device|16x5-cm silicone elastomeric dressing that adheres to the skin using a pressure-sensitive silicone adhesive.
15946035|NCT03294863|Other|Standard of Care|Without the embrace Scar Therapy Device
15946036|NCT03294850|Procedure|Bariatric surgery|Subjects enrolling in the study who are undergoing bariatric surgery as part of their medical care will be studied
15946037|NCT03294850|Device|HepQuant SHUNT Dual Cholate Liver Diagnostic Kit|For the experimental group, the device will be used to monitor the effect of bariatric surgery on liver function. For the active comparator group, the device will be used for the assessment of baseline liver function.
15946038|NCT03294824|Other|blood sample|peripheral blood samples are collected
15946039|NCT03294811|Device|Telemonitoring|The telemonitoring interference in the telemonitoring arm consists of a smartphone application that helps the patient to take their medication in time and to take their blood pressure and weight on a daily basis in order to improve the medication uptitration and medication compliance.
15946040|NCT03294798|Biological|Human Serum Albumin/interferon alpha2b fusion protein|In experiemental groups, each subject will recieve 600,750,900mg once per two weeks during multiple dose period.
15946041|NCT03294798|Biological|Pegasys|In comparator group, each subject will recieve 180mcg once per week.
15946196|NCT03293706|Other|CHO Experimental 4 Maltodextrin|mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption
15946042|NCT03294785|Procedure|Chuna manual therapy|Chuna is a Korean manual therapy that has absorbed and incorporated aspects of osteopathic manipulative medicine. Chuna manual therapy utilizes spinal manipulation techniques for joint mobilization including high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement, muscle energy, and fascial techniques.
15946043|NCT03294785|Drug|Conventional medication|Conventional drugs will be prescribed in an individually-tailored, pragmatic method with reference to most frequently used treatments in patients with a primary diagnosis of cervical sprain/strain group, cervical disc disorder with radiculopathy group, or cervicalgia according to Korean Health Insurance Review and Assessment (HIRA) 2014 statistics.
15946044|NCT03294785|Procedure|Physical therapy|Physical therapy will be prescribed in an individually-tailored, pragmatic method with reference to most frequently used treatments in patients with a primary diagnosis of cervical sprain/strain group, cervical disc disorder with radiculopathy group, or cervicalgia according to Korean Health Insurance Review and Assessment (HIRA) 2014 statistics.
15946045|NCT03294772|Other|hand sanitizer|DCCs received alcohol-based hand sanitizer and a program educational.
15946046|NCT03294772|Other|liquid soap|DCCs received liquid soap and a program educational.
15946047|NCT03294759|Other|Bio ACL|Bone marrow aspirate will be centrifuged using the Arthrex Angel system to optimally concentrate the cells for implantation. The graft for the experimental groups will be wrapped with a sterile amnion matrix wrap, supplied by Arthrex
15946048|NCT03294759|Other|Control|Normal ACL reconstruction technique with either patella or hamstring autograft
15946049|NCT03294746|Other|Clinical evaluations|At study entry , 6 weeks and 6 months, enrolled patients will undergo pulmonary physiology tests, assessment of respiratory symptoms, respiratory examination, pulse oximetry, blood draws, respiratory and quality of life assessment. Data from bronchoscopy assessments will be collected, if this has been performed as part of routine care.
15946050|NCT03294746|Other|Thoracic CT|At study entry, patients will undergo thoracic CT before treatment adaptation, unless a study-quality scan* has already been performed . Thoracic CT will be repeated at 6 weeks. All images will be centrally reviewed for radiology scoring.
15946051|NCT03294733|Procedure|Ultrasound|This ultrasound machine is owned by the department of orthopaedic surgery and is capable of up to 15 MHz image definition with its linear transducer
15946052|NCT03294720|Procedure|Bio-ACL|ACL reconstruction with either hamstring or patellar autograft, wrapped in amion collagen wrap, and stem cells from bone marrow aspirate.
15946053|NCT03294720|Device|amnion wrap and BMAC|amnion collagen wrap and bone-marrow aspirate in ACL reconstruction autograft
15946054|NCT03294707|Drug|AG10 oral tablet|Active single ascending dose
15946055|NCT03294707|Drug|Placebo Oral Tablet|Placebo single dose
15946056|NCT03294694|Drug|Ribociclib|Each treatment cycle lasts 28 days. Ribociclib, 1 time per day by mouth for 21 days, followed by 1-week of rest (28-day cycle)
15946057|NCT03294694|Drug|PDR001|Each treatment cycle lasts 28 days. (PDR001) will be administered once every 28 days (by intravenous infusion) over about 30 minutes (or up to 2 hours, if necessary) for the first infusion and over about 30 minutes for all following infusions.
15946058|NCT03294694|Drug|Fulvestrant|Each treatment cycle lasts 28 days. Fulvestrant will be administered during Cycle 1 on days 1 and 15, and then on day 1 of each 28-day cycle thereafter.
15946059|NCT03294681|Device|Objective measures with CSEP|Objective measures to be conducted with Custom SoundTM EP 5 software and the CP900 series sound processor in CI532 and CI512 Cochlear Implant recipients
15946060|NCT03294668|Behavioral|KONTAKT Australia|KONTAKT is a manualized Social skills group training program designed for children and adolescents on the Autism Spectrum aimed at improving communication, social interaction skills, the severity of ASD symptoms, and the ability to empathise and adapt in a group setting. The KONTAKT participants (4-8 participants) meet face to face weekly for 16 weeks for an hour and a half in a group facilitated by two trainers.
15946061|NCT03294668|Other|Super Chef|The Super Chef is a cooking group designed for this study for adolescents on the Autism Spectrum, aimed at teaching basic cooking skills in a social environment. The Super Chef participants (4-8 participants) meet face to face weekly for 16 weeks for an hour and a half in a group facilitated by two trainers.
15946062|NCT03294655|Behavioral|Pilot Resilience Building Intervention|The intervention will include a brief one-on-one visit in which psychoeducational information on building resilience will be given via a PowerPoint presentation, which will include exercises for the participants to engage in over the following four weeks in their daily lives. After the presentation participants will also develop a personalized intervention plan where they will choose at least five areas of the American Psychological Association 10 Strategies for Building Resilience on which to specifically focus. Participants will also receive a pamphlet of abbreviated information from the PowerPoint presentation.
15946063|NCT03294642|Dietary Supplement|Potatoes|Pureed russet potatoes will be used as a carbohydrate supplement for participants during one of the three cycling challenges.
15946064|NCT03294642|Dietary Supplement|Carbohydrate Gel|Commercially available PowerBar PowerGel will be used for the carbohydrate gel condition during one of the three cycling challenges.
15946065|NCT03294642|Dietary Supplement|Water|Water will be used as a control during one of the three cycling challenges (participants will not receive any carbohydrate supplementation).
15946066|NCT03294629|Device|SensAwake™ modification|SensAwake™ is a new design based on the research of Doctor Ayappa 5 years ago. The SensAwake™ modification to the Fisher and Paykel automatically titrating positive airway pressure (APAP) device aims to sense whether the patient is awake via respiratory patterns that differentiate between sleep and wake. Upon sensing that the patient is awake the device is able to reduce positive airway pressure PAP aiming to improve patient comfort which should result in more consolidated sleep.
15946067|NCT03294616|Device|transcutaneous electroacupuncture|Weak electrical current will be generated by the device and delivered via skin surface electrodes to acupuncture points related to gastrointestinal functions
15946068|NCT03294603|Drug|CC-220|1mg [14C]-CC-220 will be administered as a single dose
15946069|NCT03294603|Radiation|[14C]|Single dose of [14C]-CC-220 will contain approximately 1.4 μCi of radioactivity
15946070|NCT03294590|Other|OHT Parent targeted text messages|For the Oral health text message (OHT) group, the parent targeted text messaging program will include two core topics and a menu of options to choose from, all of which pertain to oral health.
15946072|NCT03294577|Drug|Pegfilgrastim|PEGFILGRASTIM is a long-acting granulocyte colony-stimulating factor that stimulates the growth of neutrophils, to reduce the incidence of fever and infection in patients with certain types of cancer who are receiving chemotherapy that affects the bone marrow.
15946073|NCT03294577|Drug|Plinabulin|Plinabulin (BPI-2358) is a synthetic, low molecular weight, new chemical entity that belongs to the diketopiperazine class of compounds. Plinabulin is intended for intravenous (IV) infusion and is diluted in D5W and administered for 30 minutes (± 5 minutes).
15946074|NCT03294577|Other|D5W Placebo|Placebo 250 ml D5W to match the administration of plinabulin diluted in 250 ml D5W
15946075|NCT03294577|Drug|Docetaxel, doxorubicin, and cyclophosphamide (TAC)|Docetaxel is a type of chemotherapy medicine called an taxane. Doxorubicin is a type of chemotherapy medicine called an anthracycline. Cyclophosphamide is a type of chemotherapy medicine called an alkylating agent.
15946076|NCT03294564|Biological|Typhoid Vi Polysaccharide Vaccine|Salmonella typhi capsular polysaccharide vaccine (Typhoid Vi Polysaccharide Vaccine): Each dose of 0.5ml Salmonella typhi capsular polysaccharide vaccine (Sanofi Pasteur, SA) is formulated to contain 25μg of purified Vi polysaccharide in a colorless isotonic phosphate buffered saline (pH 7±0.3), 4.150mg of sodium chloride, 0.065mg of disodium phosphate, 0.023mg of monosodium phosphate and 0.5ml of sterile water for injection. It is indicated for use by humans aged 2 years and older for protection against typhoid fever.
15946077|NCT03294564|Biological|Placebo|The placebo injection will consist of 0.5mL of saline.
15946078|NCT03294551|Behavioral|HPV Vaccine Reminder Recall - Autodialer|Investigators will send out HPV vaccine reminder recall notices via autodialer message to the parents of adolescents 11-14 years of age who are eligible to receive a dose of the HPV vaccine per the records in the New York State Immunization Information System (NYSIIS). The investigators will be testing the effectiveness and cost effectiveness of the various modalities or reminders as compared to the standard of care control (no reminders)
15946079|NCT03294551|Behavioral|HPV Vaccine Reminder Recall - Texting|Investigators will send out HPV vaccine reminder recall notices via text message to the parents of adolescents 11-14 years of age who are eligible to receive a dose of the HPV vaccine per the records in the New York State Immunization Information System (NYSIIS). The investigators will be testing the effectiveness and cost effectiveness of the various modalities or reminders as compared to the standard of care control (no reminders)
15946080|NCT03294538|Drug|Generic Estradiol Vaginal Cream USP, 0.01%|Vaginal cream, generic formulation of the brand product.
15946081|NCT03294538|Drug|Estrace® Vaginal Cream USP, 0.01%|Vaginal cream, brand product.
15946082|NCT03294538|Drug|Vehicle Vaginal Cream|Vaginal cream, placebo. Has no active ingredient
15946083|NCT03294525|Drug|Escitalopram Pill|escitalopram 10~20mg/day
15946084|NCT03294525|Drug|Duloxetine|duloxetine 30~120mg/day
15946085|NCT03294525|Drug|Mirtazapine Pill|Mirtazapine 15~45mg/day
15946086|NCT03294525|Drug|Other Antidepressants|
15946087|NCT03294512|Behavioral|MAWDS data entry on app|Utilize the smartphone app to enter their MAWDS (Medication, Activity, Weight, Diet, Symptoms) data
15946088|NCT03294499|Other|Questionnaire|Patients will be asked to complete one off questionnaire.
15946089|NCT03294486|Drug|Combination of TG6002 and 5-flucytosine (5-FC, Ancotil®)|"Phase 1, TG6002 administered in a total volume of 250mL of saline solution (0.9 %) as three intravenous infusions at the following doses:
~Dose 1 : 5.0 log10 pfu •Dose 2 : 6.0 log10 pfu •Dose 3 : 7.0 log10 pfu •Dose 4 : 7.5 log10 pfu
~Dose 5 : 8.0 log10 pfu •Dose 6 : 8.5 log10 pfu Additional dose levels •Dose 2-1 : 5.5 log10 pfu •Dose 3-2 : 6.5 log10 pfu Phase 2a, treatment IV at the recommended Phase 2 dose 5-Flucytosine (5-FC) is provided in its commercial packaging with brand name ANCOTIL 500 mg, tablet (Ancotil®) marketed by MEDA Pharma: polypropylene tube containing 100 tablets.
~5-FC administered orally as 500 mg tablets taken 4 times per day (qid). Daily starting dose is 200 mg/kg. The daily dose will be adjusted at Day 19 following the measurement of 5-FC plasma concentration at steady state (Day 7), which should be kept below 100 mg/L."
15946090|NCT03294473|Behavioral|R/R - Autodialers|Investigators will send out flu vaccine reminder recall notices via autodialer message to the parents of children 6 months - 17 years of age who are due for the flu vaccine, per the records in the New York State Immunization Information System (NYSIIS).
15946091|NCT03294473|Behavioral|R/R - Texting|Investigators will send out flu vaccine reminder recall notices via text message to the parents of children 6 months - 17 years of age who are due for the flu vaccine, per the records in the New York State Immunization Information System (NYSIIS).
15946092|NCT03294473|Behavioral|R/R - mailed postcard|Investigators will send out flu vaccine reminder recall notices via mailed postcards to the parents of children 6 months - 17 years of age who are due for the flu vaccine, per the records in the New York State Immunization Information System (NYSIIS).
15946093|NCT03294460|Drug|Alcohol (Oral)|Oral Self-administration
15946094|NCT03294460|Drug|Alcohol (IV)|IV Self-administration
15946095|NCT03294460|Drug|Alcohol (Ethanol)|IV and Oral Self-administration
15946096|NCT03294447|Behavioral|Fall Prevention by the Occupational Therapist|The interventions included education on adaptive equipment for household activities, adaptive equipment for activities of daily living, proper footwear in all environments, proper body mechanics, position changes, home environment set up, high fall risk activities, safety awareness, low vision and home exercises programs. In addition, discussion and education occurred to improve participation in valued occupations.
15946097|NCT03294434|Other|Diffusion tensor Imaging (DTI)|Diffusion tensor Imaging (DTI) is a technique sensitive to the ordered diffusion of water along white matter tracts and can detect subtle disruption. A diffusion tensor signature method was developed that splits the tensor information into isotropic and anisotropic diffusion components. This can differentiate regions of pure tumour from invaded white matter.
15946098|NCT03294421|Procedure|combined access tympanomastoidectomy|Trans canal surgery with the use of a surgical microscope with a rigid endoscope measuring 14cm of length with 0º and 30º angulation allowing better visualization and removal of the cholesteatoma before mastoid debridement. In this surgery, mastoid debridement is conducted only if there was no full endoscopic removal of the cholesteatoma. The other procedures of this type of surgery are similar to the standard tympanomastoidectomy technique.
15946197|NCT03293693|Other|0.5 g beta-glucan|Dietary cross-over study with beta-glucan fiber
15946198|NCT03293693|Other|3.5 g beta-glucan|Dietary cross-over study with beta-glucan fiber
15946199|NCT03293693|Other|8 g beta-glucan|Dietary cross-over study with beta-glucan fiber
15946099|NCT03294421|Procedure|standard closed tympanomastoidectomy|"Supine position and general anesthesia with orotracheal intubation
~Antisepsis and placing of sterile fields
~Local anesthesia of the external auditory canal with lidocaine 2% and adrenaline 1:100. 000 UI
~Retroauricular incision
~Removal of the temporal muscle fascia
~Elevation of the surgical flap of the tympanic meatus
~Visualization and exploration of the cholesteatoma
~Exploration of the ossicular chain
~Mastoid debridement
~Conservation of the upper posterior wall of the auditory conduct
~Removal of the cholesteatoma
~Tympanoplasty with the temporal fascia
~Retroauricular suture with vycril 3.0 and mononylon 4.0"
15946100|NCT03294408|Diagnostic Test|multimodal imaging|
15946101|NCT03294395|Drug|Ertapenem 1000 MG|single dose 1000mg intramuscular injection
15946102|NCT03294395|Drug|Fosfomycin Oral Suspension|single dose 6g oral suspension
15946103|NCT03294395|Drug|Gentamicin Sulfate, Injectable|single dose 5mg/kg (maximum 400mg) intramuscular injection
15946104|NCT03294395|Drug|Ceftriaxone|single dose 500mg intramuscular injection
15946105|NCT03294382|Drug|Botulinum toxin type A|5U botulinum toxin in 0.1 mL normal saline, injected in two points at one side, 2.5U per point, local injection
15946106|NCT03294382|Drug|Placebo|0.1 mL normal saline, injected in two points at one side, 0.05 mL per point, local injection
15946107|NCT03294369|Other|Observational|This is an observational study. No specific diagnostic or therapeutic procedure will be performed due to the study.
15946108|NCT03294356|Other|FT210771|An electronic cigarette
15946109|NCT03294356|Other|FT210751|An electronic cigarette
15946110|NCT03294356|Other|6T30134157764|An electronic cigarette
15946111|NCT03294356|Other|G41A7C071|An electronic cigarette
15946112|NCT03294356|Other|M011161212|An electronic cigarette
15946113|NCT03294356|Other|FT21002|A combustible cigarette
15946114|NCT03294343|Procedure|salpingo-oophorectomy only by laparoscopy|Salpingo-oophorectomy are provided for carriers with mutation genes of BRCA1, BRCA2 (both belonging to mutation genes of hereditary breast and ovarian cancer syndrome, HBOCS) and ATM, BRIP1, RAD51, RAD51C, and RAD51D (all belonging to mutation genes of other hereditary ovarian cancer syndrome). Detailed multi-disciplinary counseling, decision-making analysis before surgeries, and long-term follow-up and health management after surgeries are provided for all participants.
15946115|NCT03294343|Procedure|salpingo-oophorectomy with hysterectomy by laparoscopy|Salpingo-oophorectomy with hysterectomy are provided for carriers with mutation genes of MLH1, MSH2, MSH6, PMS2, EPCAM (all belonging to mutation genes of Lynch syndromes) and STK11. Detailed multi-disciplinary counseling, decision-making analysis before surgeries, and long-term follow-up and health management after surgeries are provided for all participants.
15946116|NCT03294343|Other|Follow-up|Detailed multi-disciplinary counseling, decision-making analysis and long-term follow-up are provided for carriers with any mutation genes but refusal to any risk-reducing gynecologic surgeries
15946117|NCT03294330|Drug|IC-Green KIT|fluorescence lymphangiography with the use of IC-Green
15946118|NCT03294317|Device|His bundle pacing|Medtronic SelectSecure SureScan MRI model 3830 lead
15946119|NCT03294304|Drug|Nivolumab|Nivolumab will be given at a fixed dose of 360 mg IV over 30 minutes on Day 8 every 21 days for 4 cycles.
15946120|NCT03294304|Drug|Cisplatin|Cisplatin will be given at 70 mg/m2 IV over 30 minutes on Day 1 every 21 days, and based on treating physician's discretion, split-dose cisplatin can be given at 35 mg/m2 IV Day 1 and Day 8 every 21 days for 4 cycles.
15946121|NCT03294304|Drug|Gemcitabine|Gemcitabine will be given at 1000 mg/m2 IV over 30 minutes on days 1, 8, and every 21 days for 4 cycles.
15946122|NCT03294291|Procedure|Quadratus lumborum block|Postoperative pain procedure
15946123|NCT03294291|Procedure|Caudal block|Postoperative pain procedure
15946124|NCT03294278|Other|ablation plus ICD|Defibrillator, radio-frequency catheter ablation
15946125|NCT03294265|Behavioral|Peer support sessions|"Stages of mourning and motivation Patients introduce themselves, share their experience and mention a strategy on moving on to the next stage Reminder of metabolic control goals Leaders write on the board metabolic variables and ask everybody the goal values. Patients share their results and mention plans to improve them Self-care activities Leaders ask who owns a glucometer, how regularly they use it, its importance and consequences of not doing so.
~Simplified meal plan Everyone brings a snack. Leaders ask if each snack is appropriate, how everyone carries out their meal plan, barriers and possible strategies Activities to increase physical activity Everyone compares who achieves 10 thousand steps/day and who doesn't, then mention benefits of exercise"
15946126|NCT03294265|Behavioral|Reminders|"Creation of a group on WhatsApp to send leaders and patients a weekly reminder on the different areas of self-care, such as foot care, self-monitoring, adherence to meal plan, medication and exercise.
~This intervention will be applied to both groups."
15946127|NCT03294252|Drug|5-Fluorouracil|Presentation: Concentrated solution for concentrated infusion in vials containing 250 mg, 500 mg, 1 g and 5 g, in 5 ml, 10 ml, 20 ml and 100 ml respectively, providing a 50 mg / ml solution. Dosage: 400mg / m2. Administration: IV. Day of administration: between 1 h and 24 h before CIPPA.
15946128|NCT03294252|Drug|L-Folinic acid|Presentation: lyophilisate for parenteral use, dosed at 25 mg, and in the form of a solution for injection by IM or IV dosed at 25 mg / 2.5 ml. Dosage: 20mg / m2. Administration: IV. Day of administration: between 1 h and 24 h before CIPPA.
15946129|NCT03294252|Drug|Oxaliplatin|Concentrated solution for infusion dosed with 50 mg and 100 mg. Dosage: depending on the dose range assigned to inclusion (from 90mg / m2 to 300mg / m2). Administration: the solution is packaged in a syringe which is subsequently used for injection and not in a conventional bag. The product is administered in a high-pressure injector, during the PIPAC. Day of administration : J1 of PIPAC
15946130|NCT03294239|Procedure|Transurethral extraction of bladder stone(s)|Patients will have transurethral approach for management of their bladder stones. Either pneumatic or Holmium:YAG laser will be used for stone distentegration. Stone basket and/or Elics current evacuation will be used to retrieve stone fragments. Urethral catheter will be applied for 48 hours.
15946157|NCT03294031|Other|Conventional Exercise|All sessions started with a 15-minute warm-up phase based on walking performance and joint mobility exercises. It was followed by a 35-minute second phase, which included low-impact aerobics (music tempo was set at 120 beats per minute), gross motor coordination tasks and balance activities. The final 5-minute phase focused on gentle stretching exercises.
15946158|NCT03294018|Other|Recording heart rate changes|Recording heart rate changes during planned sugammadex administration.
15946131|NCT03294239|Procedure|percutaneous extraction of bladder stone(s)|Patients will have percutaneous approach for management of their bladder stones. After initial cystoscopy a Foley's urethral catheter will be fixed for continuous irrigation. Then, the bladder will be filled to capacity with normal saline. Access to the distended bladder will be obtained by 10-gauge needle in the midline 1-2 cm above the pubic bone. Once suitable placement is confirmed with return of fluid, a guide wire will be passed through the needle into the bladder. Dilatation will be done using 8-10 Fr coaxial dilators then single fascial dilator with placement of 16 Fr Amplatz sheath as a working tract. No ultrasonic or fluoroscopic guidance will be used. Stone basket will be used to extract the stone. If the stones were larger than the used sheath, disintegration will be performed with a pneumatic lithotrite. Primary skin closure of the suprapubic stab wound by one stitch will be done and the urethral catheter will remain for 48 hours.
15946132|NCT03294226|Device|AuraGain|After anesthetic induction without neuromuscular blocking agent, AuraGain is inserted.
15946133|NCT03294226|Device|I-gel|After anesthetic induction without neuromuscular blocking agent, I-gel is inserted.
15946134|NCT03294213|Device|aScope 4 Broncho|"Investigator is asked: In your memory, compare your daily bronchoscope and the aScope 4 Broncho just evaluated on patients admitted to the OR or ICU undergoing at least one bronchoscopy procedure Patients will not be asked to consent to participate in this study, as no patient data are obtained and the CE-marked aScope™ 4 Broncho is used within its intended use"
15946135|NCT03294200|Device|TriCinch Coil System implantation|Patients enrolled in this study with all eligibility criteria confirmed will be implanted with the TriCinch Coil System. This device offers a percutaneous treatment (access through the vein at the groin) to treat the leaking tricuspid valve, without the need for surgical intervention.
15946136|NCT03294187|Device|Wrist-worn wearables|See arm/group description.
15946137|NCT03294174|Drug|Ropivacaine injection|Ropivacaine administered to provide nerve block
15946138|NCT03294161|Drug|Immucillin DI4G|Immucillin DI4G was administered by topical use at 2% concentration once a day for 20 days associated with Meglumine antimoniate administered by intravenous route at a dosage of 20mg/kg/day, during 20 days.
15946139|NCT03294161|Drug|Meglumine antimoniate|Placebo for topical use once a day at the ulcer for 20 days associated with Meglumine antimoniate administered as the standard treatment for cutaneous leishmaniasis by intravenous route at a dosage of 20mg/kg/day, during 20 days.
15946140|NCT03294148|Other|Open-Label Placebo Treatment for Chronic Back Pain|Subcutaneous injection of 1ml medical grade saline into the lower back.
15946141|NCT03294148|Behavioral|Psychotherapy Treatment for Chronic Back Pain|Twice weekly 50 minute psychotherapy sessions for 4 weeks, plus an initial medical history session
15946142|NCT03294135|Biological|Encepur Adults|One dose of the vaccine can be administered at any one unscheduled visit depending on the detection of NT below 10. It will be administered intramuscularly into the non-dominant deltoid.
15946143|NCT03294122|Radiation|External beam radiotherapy for prostate cancer|Patients will receive radiotherapy for prostate cancer and possible adjuvant hormone therapies as foreseen by international guidelines. No modification of standard regimens is considered. PCa patients are treated with 78 Gy, 2Gy/fraction, in exclusive setting and with 70 Gy, 2Gr/fraction in the post-prostatectomy setting. Lymph node irradiation is performed (50 Gy, 2Gy/fraction) when indicated by risk class.
15946144|NCT03294122|Radiation|External beam radiotherapy for head and neck cancer|Patients will receive radiotherapy for head and neck cancer and possible concomitant chemotherapies as foreseen by international guidelines. No modification of standard regimens is considered. In curative setting, HNCa patients are treated at a total dose of 70 Gy, 59.4 Gy and 56.1 Gy in 33 fractions to high risk Planning Target Volume (PTV), intermediate risk and low risk PTV, respectively. In high risk post-operative setting they are treated with 66 Gy (according to histopathological features), 60 Gy and 56.1 Gy to high, intermediate and low risk PTV, respectively; while, in intermediate risk post-operative case, intermediate and low risk PTV are irradiated with 60 Gy and 54 Gy, respectively. Chemotherapy will be platinum based (weekly or 3-weekly cisplatin).
15946145|NCT03294109|Drug|Abdominal wall block with liposomal bupivicaine|Abdominal wall block with liposomal bupivicaine
15946146|NCT03294096|Dietary Supplement|Routine care + Nutritional product|Routine post-op care + Nutritional supplement by specific product
15946147|NCT03294096|Other|Routine care|Routine post-op care
15946148|NCT03294083|Biological|Pexastimogene Devacirepvec (Pexa-Vec)|Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells
15946149|NCT03294083|Biological|Cemiplimab|Cemiplimab is a monoclonal antibody to Programmed Death-1 (PD-1)
15946150|NCT03294070|Combination Product|Fimasartan plus amlodipine besylate|Fimasartan 60 mg plus amlodipine besylate 5 mg or Fimasartan plus 12.5 mg HCTZ plus one 5 mg amlodipine besylate
15946151|NCT03294057|Behavioral|Tele-coaching programs|Tele-coaching program conducted 12 times (one time for one week), and more than 20 minutes each by a trained nurse. Coaching content specifically, 1) evaluation, 2) facing and accepting the health crisis, 3) setting up new goals, 4) making decisions and plans, and 5) practice.
15946152|NCT03294057|Behavioral|ICT programs|ICT programs that include health information learning by disease and self-management based on Smart Management Strategy for Health (SMASH)
15946153|NCT03294057|Behavioral|A book about chronic disease|A Take-home book about chronic disease are provided for self-education
15946154|NCT03294044|Behavioral|ICT programs|ICT programs that include health information learning by disease and self-management based on Smart Management Strategy for Health (SMASH).
15946155|NCT03294044|Behavioral|A book about chronic disease|A Take-home book about chronic disease are provided for self-education
15946156|NCT03294031|Other|Pilates|"Warm-up exercises included Abdominal and costal breathing and Pelvic Clock. Some exercises included in the main part of the mat session were Arm arcs, Curls up, Femur arcs, Shoulder bridge, Leg circles, among others. The main part of the sitting/standing session included in standing position exercises like Standing on one leg with support, Neck rolls, Side leg lift with support and in sitting position Spine stretch 5, Elbows back with hands behind his head, Heel/knee slides, Shoulder drops, Knee folds, among others. In mat sessions, cooling exercises included in standing position Hamstring stretch and Abdominal Breathing and Rest position and in sitting/standing session Stretching and Abdominal Breathing."
15946193|NCT03293706|Other|CHO Experimental 1 Slowly Digested|mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption
15946159|NCT03294005|Diagnostic Test|Thyroid ultrasonography|Each subject had been transverse and longitudinal views of thyroid ultrasonography with high-resolution ultrasound (7-14 MHz) (HP Image Point-HS, Toshiba SSA250, GE ,Aloka SSD-1200 and Siemens S2000) that was performed by our partners - endocrinologist in all patients.
15946160|NCT03293992|Drug|0.01% RO7058584|Once daily morning administration for 7 days
15946161|NCT03293992|Drug|0.1% RO7058584|Once daily morning administration for 7 days
15946162|NCT03293992|Drug|1% RO7058584|Once daily morning administration for 7 days
15946163|NCT03293992|Drug|Matching Placebo|Once daily morning administration for 7 days
15946164|NCT03293992|Drug|Latanoprost 0.005%|Once daily morning or evening dosing
15946165|NCT03293979|Diagnostic Test|Test A i Flu A&B implemented in emergency service|Test A i Flu A&B implemented in emergency service
15946166|NCT03293940|Procedure|Cryoablation|The cryoablation procedure, a needle will be inserted and directed toward the target pain area. More than one needle may need to be used. A CT scan will be done during the procedure to help guide the needle which will be held in position by the study doctor(s) once it reaches the target area. With the needle(s) in place, the study doctor(s) will freeze the nerve over 5 minutes. A 3 minutes thaw will follow, then a second 5 minutes freeze and a final 3minute thaw. This portion of the procedure can last from 25 to 45 minutes. Once the nerve has been properly treated, the cryoablation needle(s) will be withdrawn.
15946167|NCT03293940|Procedure|Therapeutic Peripheral Nerve Block (tPNB) Injection|"During the nerve block procedure, a needle will be inserted and directed toward the target pain area. More than one needle may need to be used. A CT scan will be done during the procedure to help guide the needle which will be held in position by the study doctor(s) once it reaches the target area and anesthetic will be injected into the targeted area.
~The tPNB injection consists of 4 cc of 0.25% Bupivicaine and 1 cc of 6mg/ml betamethasone."
15946168|NCT03293927|Drug|Fentanyl|The patient will receive IV fentanyl
15946169|NCT03293927|Drug|Dexmedetomidine|The patient will receive IV dexemedetomidine
15946170|NCT03293914|Behavioral|Lifestyle Redesign|Individualized lifestyle intervention incorporating the following topics: Diabetes knowledge; access to healthcare; communication with healthcare providers; incorporation of diabetes self-care tasks within daily habits and routines; social support; and emotional well-being. Participants receive approximately 8 hours of intervention by a licensed occupational therapist with training in diabetes education, motivational interviewing and the intervention protocol.
15946171|NCT03293901|Behavioral|Exercise|Treadmill exercise for 60 minutes with load carriage (weighted vest, 30% body weight) completed three times during the 6 day kinetic period.
15946172|NCT03293875|Behavioral|Encuentro|a behavioral intervention designed to increase HIV testing rates and reduce behaviors that place individuals who use drugs at risk of contracting HIV
15946173|NCT03293862|Device|prophylactic polypropilene mesh|Placement of onlay polypropilene prophylactic mesh after midline fascial closure.
15946174|NCT03293862|Procedure|Midline Fascial Closure|midline fascial closure using uninterrupted PDS 0 suture
15946175|NCT03293862|Device|vacuum drainage system|Placement of a subcutaneous vacuum drainage system
15946176|NCT03293849|Other|Patient Navigation|The patient navigator will discuss the results and supportive care recommended interventions of the multidisciplinary team with the patient. Those interventions which are accepted by patient are initiated when possible, and referrals are made as planned. The study patient navigator will review advance directive planning with those patients who are candidates to complete an advanced directive under Mexican law, and will facilitate the resources to complete the advance directive.
15946177|NCT03293836|Procedure|Radiofrequency ablation|Radiofrequency ablation of insufficient saphenous and perforating veins using Closure Fast and Closure Stylet catheters (medtronic)
15946178|NCT03293836|Procedure|Multilayer Compressive Bandage|Individual receive multilayer compressive bandage once a week
15946179|NCT03293823|Behavioral|VSOP training|a computerized cognitive training of attention and processing speed
15946180|NCT03293823|Behavioral|MLA control|a computerized cognitive intervention of multiple mental leisure activities
15946181|NCT03293810|Other|Observational study|Post-Authorization Safety Study
15946182|NCT03293797|Behavioral|Abbreviated-Mindfulness-based Therapy|A-MBT will be delivered in group format, 120 minutes per week, for 5 consecutive weeks with 10-20 participants per group.
15946183|NCT03293784|Combination Product|Nivolumab+Ipilimumab in combination with Anti TNF-α Certolizumab|"Induction phase: Nivolumab (1mg/kg) and Ipilimumab (3 mg/kg) injected at Week 0, 3, 6, and 9 with Certolizumab injected at the dose of 400mg at weeks 0, 3, and 6, and at the dose of 200mg at week 9.
~Maintenance phase: Nivolumab (3 mg/kg) alone injected from week 12 and then every 2 weeks with Certolizumab (200 mg) injected from week 12 and then every 2 weeks."
15946184|NCT03293784|Combination Product|Nivolumab+Ipilimumab in combination with Anti TNF-α Infliximab|"Induction phase: Nivolumab (1mg/kg) and Ipilimumab 3 mg/kg injected at Week 0, 3, 6, and 9 with Infliximab (5mg/kg) injected at weeks 0, 3 and 6.
~Maintenance phase: Nivolumab (3 mg/kg) alone injected from week 12 and then every 2 weeks with Infliximab (5mg/kg) injected from week 14 and then every 8 weeks."
15946185|NCT03293771|Other|Focus group interviews|Focus group participants will be asked about their postoperative urogynecologic experience. Confidentiality will be enforced and participants will be made aware that they may opt out of answering any questions.
15946186|NCT03293771|Diagnostic Test|Questionnaire packet|Participants will be asked to complete a questionnaire packet comprised of three previously validated questionnaires and one newly created focused questionnaire. They will be asked to complete the new questionnaire again 2 weeks later. We estimate about 10 minutes will be required to complete the packet.
15946187|NCT03293745|Behavioral|Face to Face CBT-I (F2F)|CBT-I delivered in-person by the therapist.
15946188|NCT03293745|Behavioral|Telemedicine CBT-I (TM)|CBT-I delivered via American Academy of Sleep Medicine Telemedicine video conference System by the therapist.
15946189|NCT03293732|Biological|DCB07010|A protein based adjuvant originated from prokaryotic organism.
15946190|NCT03293732|Biological|HA antigens|HA antigens from three strains of influenza virus ( 7.5 μg of HA each strain).
15946191|NCT03293719|Device|BPK-S Integration UC|Primary Knee Endoprosthesis
15946192|NCT03293706|Other|CHO Control 1 and 2 Glucose|mixed in 237 ml/8 fl. oz. of a flavored non-caloric beverage; 1 time consumption
15980938|NCT03029780|Biological|Yervoy|Specified dose on specified days
15946201|NCT03293667|Other|Exploratory synovial fluid analysis|An additional blood sample (3 10 ml tubes) and an additional specific analysis to characterize subpopulations of regulating T lymphocytes infiltrating the synovium of RA patients and comparing them with those of peripheral blood.
15946202|NCT03293654|Drug|MB02|Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion.
15946203|NCT03293654|Drug|US licenced Avastin®|Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion.
15946204|NCT03293654|Drug|EU approved Avastin®|Solution for intravenous infusion, single dose of 3mg/kg, administered as 90-minute infusion.
15946205|NCT03293641|Dietary Supplement|Zinc Sulfate Tablets|Zinc Sulfate Tablets 3 times every 7 days for 6 months.
15946206|NCT03293641|Drug|Standard of Care|Folic Acid, Proguanil, Penicillin V, Hydroxyurea over 6 months
15946207|NCT03293628|Procedure|Vaginal Packing|This study will evaluate the role of vaginal packing after cervical conization as haemostasis technique
15946208|NCT03293615|Other|exploration|Difference of the following parameters in patients i) with DM, ii) with another inflammatory myopathy iii) without neuromuscular disease.
15946209|NCT03293602|Device|F-MISO PET imaging|F-MISO PET imaging will be added to the preoperative staging explorations of a patient with high risk prostate cancer candidate to radical prostatectomy. Patient will be selected during multidisciplinary meeting and urology consultation of Bordeaux and Toulouse university hospitals. Functional MRI imaging should be available before surgery. If patient consent to participate in the study, F-MISO PET imaging will be planed before prostatectomy. Results of this exam will not be considered for patient therapeutic management.
15946210|NCT03293589|Procedure|open revascularization|surgical revascularization (i.e. Bypass surgery)
15946211|NCT03293589|Procedure|endovascular revascularization|endovascular revascularization (stent, ballon angioplasty)
15946212|NCT03293576|Behavioral|Volitional Help Sheet|"This brief intervention will last around 20 minutes. The participants and the researcher will read through the list of real-life solutions the participants might find applicable to them. They will then read through the list of situations one by one. The participant will draw a coloured line between the situation and the solution which seems more appropriate to them. The volitional help sheet helps create implementation intentions, which are self-regulatory strategies taking the form of if-then plans (i.e. situation-solution plan)."
15946214|NCT03293537|Diagnostic Test|Skin conductance and Heart rate measurement|while observing selected photos the Skin conductance and heart rate will be measured.
15946215|NCT03293524|Genetic|GS010|GS010 is a recombinant adeno-associated viral vector serotype 2 (rAAV2/2) containing the wild-type ND4 gene (rAAV2/2-ND4). GS010 will be administrated via intravitreal injection containing 9E10 viral genomes in 90μL balanced salt solution (BSS) as a single baseline intravitreal injection.
15946216|NCT03293524|Drug|Placebo|The placebo is a BSS, sterile, apyrogenic solution and used for ocular surgery. The placebo will be administered via intravitreal injection in a volume of 90 μL.
15946217|NCT03293511|Drug|intranasal oxytocin|24 IU of oxytocin nasal spray will be applied to each subject.
15946218|NCT03293511|Drug|intranasal placebo|24 IU of of placebo nasal spray will be applied to each subject.
15946219|NCT03293498|Biological|NanoFlu|Vaccine
15946220|NCT03293498|Biological|Fluzone HD - Day 0|Vaccine
15946221|NCT03293498|Biological|Fluzone HD - Day 21|Vaccine
15946222|NCT03293498|Other|Saline - Day 21|Placebo
15946223|NCT03293485|Drug|Imipenem+Cilastatin/Relebactam|Imipenem+Cilastatin/Relebactam 200/100 mg to 500/250 mg, depending on renal function, 30-minute IV infusion once every 6 hours
15946224|NCT03293472|Drug|Ropivacaine|"Procedure: Continuous Epidural Anesthesia Local anesthetic injection to the cerebrospinal fluid (subarachnoid space) at the L3-L4 or L4-L5 level Drug: ropivacaine Other name: Ropimol 0.5% ropivacaine (isobaric) 4.5 ml for the patients < 160 cm tall, 5.0 ml for 161-170 cm tall, 5.5 ml for 171-180 cm tall, and 6.0 ml > 180 cm, supplementary ropivacaine bolus doses as required, followed by 0.2% ropivacaine, 1 ml/h for the postoperative period Device : The Wiley Spinal Catheter-Over-Needle System for Continuous Spinal Anesthesia 4-6 23-gauge intrathecal cannula over a 27-gauge pencil-point spinal needle"
15946225|NCT03293472|Drug|Bupivacaine|"Procedure: Continuous Epidural Anesthesia Local anesthetic injection to the subarachnoid space at the L3-L4 or L4-L5 level Drug: bupivacaine Loading dose of bupivacaine followed by 0.12% bupivacaine, 1 ml/h Other name: bupivacaine
~Device:
~The Wiley Spinal Catheter-Over-Needle System for Continuous Spinal Anesthesia 4-6 23-gauge intrathecal cannula over a 27-gauge pencil-point spinal needle"
15946226|NCT03293459|Procedure|Shunt Occlusion|Catheterization of the Porto-systemic shunt (via the left renal vein for gastro-lienorenal shunt) will be accomplished using a catheter and occlusion will be performed with balloon catheter/vascular plug. Occlusion venography is then performed to define the type of varix/varices and the anatomy of the venous drainage followed by infusion of sclerosant. The occluded balloon were inflated and remained in place for a maximum of 24 hours deflated under fluoroscopy the next day/plug is deployed and sclerosant is injected to obliterate the shunt and follow up CT is done to look for completion on the next day. Follow up CT abdomen is done periodically to look for effect on shunt and organ.
15946227|NCT03293459|Dietary Supplement|Standard Medical Treatment (SMT)|These will include diet rich in BCAA (branch chain amino acids), laxatives and rifaximin
15946228|NCT03293446|Diagnostic Test|Urinary acidification test|Urinary acidification by administration of ammonium chloride (100 mg/kg body weight, given orally) during a single-day hospital admission.
15946229|NCT03293433|Other|Blood punction|1 blood punction during the normal pathway of care of the patient. This punction will be used to perform the extraction of micro RNA.
15946230|NCT03293407|Drug|Iloprost (Ventavis, BAYQ6256)|Using Breelib device
15946231|NCT03293407|Device|Breelib nebulizer|Used for inhalation of Ventavis
15946232|NCT03293394|Device|Anodal bilateral motor cortex and cathodal spinal tDCS|10 sessions of anodal bilateral motor cortex and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks)
15946233|NCT03293394|Device|Sham bilateral motor cortex and sham spinal tDCS|10 sessions of sham bilateral motor cortex and sham spinal transcranial direct current stimulation (5 days/week for 2 weeks)
15946234|NCT03293381|Device|additional biopsies|additional biopsies
15946613|NCT03290417|Dietary Supplement|Turmeric|250mg/cap; two capsules by mouth 4 times per day
15946235|NCT03293368|Biological|Platelet rich plasma|Platelet rich plasma will be prepared from the patients own blood in the same visit using a double spin technique, then 0.5 ml of PRP will be injected per 1 cm2 of eroded oral mucosa.
15946236|NCT03293368|Drug|Triamcinolone Acetonide|0.5 ml of triamcinolone acetonide 40mg will be injected per 1 cm2 of eroded oral mucosa
15946237|NCT03293355|Behavioral|VPN|Two in-person sessions will take place one week apart for the VPN intervention targeting CHW. The intervention contents aim to utilize traditional communications tools and the latest technology to tackle challenges faced by service providers working in commune health centers and the impact of these challenges on their patients' treatment initiation, retention, and adherence. In addition, booster sessions will be offered once every month during the first three months and once every three months thereafter. The booster sessions will focus on participants' reports of their experiences, reinforcement of efforts, and continued skill building for problem solving.
15946238|NCT03293342|Behavioral|D CBT|"Intervention:
~a 3-5 session treatment of dental fear.
~Psychoeducation about anxiety
~Exploration of the individual anxiety
~Exposure to the frightening stimuli (no hiding, but actively showing in detail all components of dental treatment, preferably utilizing a mirror while doing treatment)."
15946239|NCT03293342|Combination Product|Control|"Intervention:
~Traditional treatment of dental fear common sense/ benzodiazepine"
15946240|NCT03293329|Other|Diaphragm manual therapy techniques|3 diaphragm manual therapy techniques performed by a physical therapist are employed in this experimental group during 10 minutes. The participants are situated in a seated, supine and side bending position.
15946241|NCT03293329|Other|Diaphragm mobilization through active hipopressive gymnastic exercise|Diaphragm mobilization through active hipopressive gymnastic exercise in two different postures: standing and standing bending forward.
15946242|NCT03293329|Other|Ischemic compression techniques in shoulder myofascial trigger points|Ischemic compression techniques in infraespinatus and supraespinatus myofascial trigger points during one minute each muscle. The pressure increases gradually until the individual feels a tolerable pain.
15946243|NCT03293316|Device|Transcranial Random Noise Stimulation|The transcranial random noise stimulation was delivered using a StarStim device (Neuroelectrics®, Barcelona, Spain). The electrodes were encased in a pair of saline-soaked sponges (25 cm2 ), and were secured within a Neurolectrics EEG cap over right DLPFC (F4) and right IPL (P4), according to the 10-20 international EEG system. Other details are stated under the 'intervention arm' descriptions.
15946244|NCT03293303|Behavioral|Stay Active at Home|Stay Active at Home' aims to change the behaviour of community nurses and domestic support workers by offering them an intensive training programme. Subsequently, professionals are expected to deliver goal-oriented, holistic and person-centred services focusing on supporting older adults to maintain, gain or restore their competences to engage in physical and daily activities so that they can manage their everyday life as independently as possible.
15946245|NCT03293290|Drug|PrEP|Subjects on PrEP will be followed for 1 year with quarterly assessments by trained research assistants. Study visits will take place at in New Haven and Hartford. At every scheduled visit, participants will receive a comprehensive package of preventive services, including a prescription for the next 30-day supply of TDF/FTC (with 2 refills), a symptom screen for acute HIV, risk-reduction counseling, PrEP adherence support, bleach for cleaning injection equipment, and condoms. HIV rapid testing with Orasure® will be performed quarterly; participants testing newly positive for HIV (representing seroconversions) will be followed with confirmatory testing and referred to care as needed.
15946246|NCT03293277|Drug|Intranasal Dexmedetomidine|Intranasal Dexmedetomidine
15946247|NCT03293277|Drug|Intravenous Dexmedetomidine|Intravenous Dexmedetomidine
15946248|NCT03293277|Drug|Intranasal Placebo|Intranasal Placebo
15946249|NCT03293277|Drug|Intravenous Placebo|Intravenous Placebo
15946250|NCT03293264|Behavioral|Exercise training group|"Exercise training will consist of 3 - 6 sessions per week and will cumulate in 150 min net exercise time per week. Heart rates during exercise sessions will be monitored with the aim of physical activities at moderate-intensity. Exercises will be individualized to reach the best possible improvements to the cardiovascular and musculoskeletal system. Possible disciples will include but are not limited to: cycling, rowing (ergometer), swimming, walking, nordic-walking, running, arm-cycle-ergometer or cross-trainer as well as fitness courses offered from occupational or private providers. Everyday activities which reach an effective heart rate range can account for exercise training on a home-based basis .
~Advise on complementary individual strength and coordination exercises will be added to the training program. A nutrition analyses will be completed by every subject to account for special needs of the metabolic syndrome."
15946251|NCT03293251|Procedure|Trabeculectomy with MMC|glaucoma surgeries
15946252|NCT03293238|Procedure|Joint line ultrasound|Patients will be sitting with knee bent at 90 degrees. Clinician will palpate extremity to determine if a medial or lateral approach will be made for the injection of Euflexxa into the joint space. The procedure will be aided by real time visualization utilizing ultrasound guidance.
15946253|NCT03293238|Procedure|Joint line landmark|Patients will be sitting with knee bent at 90 degrees. Clinician will palpate extremity to determine if a medial or lateral approach will be made for the injection of Euflexxa into the joint space. The procedure will not be aided by ultrasound guidance, but completed based strictly on tactile feedback from the injecting physician.
15946254|NCT03293238|Procedure|Suprapatellar ultrasound guided|Patients will be lying supine on exam table. Ultrasound will be used to capture a longitudinal view of the proximal patella and the plane between the prefemoral fat pad and suprapatellar fat pad. After the desired visualization is achieved, injection of Euflexxa will be made within the suprapatellar pouch.
15946255|NCT03293238|Procedure|Suprapatellar Landmark|Patients will be lying supine on exam table. Injecting physician will insert needle lateral to the vastus lateralis toward the suprapatellar pouch, and will inject of Euflexxa once it is believed that the needle tip is in the pouch.
15946256|NCT03293199|Procedure|Chest tube drainage|In this group, in the supine position and subsequent to prepping and draping and local anesthesia administration via lidocaine 2%, F16 or F20 (based on patients physical status) sterile plastic tube will be implemented at the level 4th or 5th intercostal space through the midaxillary line. Subsequently, the external end of the tube will be connected to water sealing bottle and water bubbles coming out will be considered as proper chest tube insertion.
15946324|NCT03292640|Drug|DFD-03 (0.1% tazarotene) Lotion|DFD-03 Lotion (0.1% tazarotene) - twice daily application
15982325|NCT03019237|Drug|anti-IgE|intranasal anti-IgE
15946257|NCT03293199|Procedure|Repetitive needle aspiration|In this group, prior to needle aspiration, patients will take the semi-supine position. Subsequent to local anesthesia via lidocaine 2%, as well as prepping and draping, G16 intravenous angiocath will be inserted through midclavicular line at the level 2nd or 3rd intercostal space. Air bubble inside the lidocaine syringe will be considered as needled entrance to pleural cavity, thus 5-10 cm of the angiocath will be import to inside of the cavity. The catheter needle will be removed and catheter will be fixed using sterile sticks. A three-way valve will be connected to external end of the catheter and a 50 ml syringe will be connected to the valve. The air suction will be performed using 50 ml syringe till end of the air suction or up to 3.5 liters of air suctioning.
15946258|NCT03293186|Combination Product|MEDICLORE|use MEDICLORE at the end of surgery as antiadhesive product
15946259|NCT03293173|Combination Product|R-CHOEP|rituximab, cyclophosphamide, doxorubicin, etoposide, vincristine, prednisone
15946260|NCT03293173|Combination Product|DA-EPOCH-R|dose-adjusted etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin, rituximab
15946261|NCT03293160|Other|Care management services|Patients who receive care management services will interact with a care manager who will take an inventory of the patient's needs (including social determinants of health such as housing) and provide guidance about available social supports and clinical resources.
15946262|NCT03293147|Other|HPLC-MS/MS-guided intervention|The HPLC-MS/MS-guided intervention consists of providing partially or totally non-adherent hypertensive patients with information on the results of their HPLC-MS/MS-based urine analysis combined with tailored targeting of the main reason(s) for the deviation from the prescribed antihypertensive treatment
15946263|NCT03293147|Other|Standard care|Standard care for hypertensive patients
15946264|NCT03293121|Behavioral|Strength and Coordination Training|Perform training exercises 3/week. Weeks 1-2: general strength (isolated muscle groups) Weeks 3-4: running-specific strength (multi-joint, upright) Weeks 5-6: power/coordination I (low amplitude/intensity) Weeks 7-8: power/coordination II (higher amplitude/intensity) Weeks 9-16: Run training. Each training session will start with a 10 minute strength & coordination warm up. Group will gradually progress from mixed run/walk for 20 minutes to a 40 minute run.
15946265|NCT03293121|Behavioral|Walking|Perform training exercises 3/week. Weeks 1-2: 30 minute walk Weeks 3-4: 35 minute walk Weeks 5-6: 40 minute walk Weeks 7-8: 45 minute walk Weeks 9-16: Run training. Each training session will start with a 10 minute walking warm up. Group will gradually progress from mixed run/walk for 20 minutes to a 40 minute run.
15946266|NCT03293108|Drug|Denosumab|Denosumab 60 mg is subcutaneously administered to osteoporotic patients at baseline, month 6 and month 12.
15946267|NCT03293108|Dietary Supplement|calcium|All women will receive daily supplements containing at least 1000 mg of elemental calcium (divided in two doses), during 18 month of the study.
15946268|NCT03293108|Dietary Supplement|vitamin D|All women will receive daily supplements containing at least 400 IU vitamin D daily during 18 month of the study.
15946269|NCT03293095|Procedure|Standard Care|The guidelines for the management according to the musculoskeletal disorder in primary care will be the treatment guidelines for the Standard Care.
15946270|NCT03293082|Device|CGM ON|The period of time when continuous glucose monitoring was used, in edition to SMBG
15946271|NCT03293082|Device|CGM OFF|The period of time when continuous glucose monitoring was not used, only SMBG
15946272|NCT03293069|Drug|Deferiprone|One 600 mg delayed-release tablets of deferiprone twice a day, for at 30 mg/kg/day
15946273|NCT03293069|Drug|Placebo Oral Tablet|the placebo twice daily morning and evening.
15946274|NCT03293056|Other|High-intensity interval Hydrogynmastics|The HIIH to PSE group during the high intensity (HI) period should remain between 16 to 18 points, while in the moderate intensity (MI) intervals around 11. The dynamic exercises will progression, in the first month will be 1 min of HI and 2 min of MI, in the second month of 1 min of HI and 1 min of MI and in the last month of 1 min of HI and 30 s of MI, until completing 30 min in total.
15946275|NCT03293056|Other|Hydrogynmastics Continuous Moderate|For the HCM group the PSE will be around 11 points during the 30 min of moderate continuous exercise. In both groups the form of intensity monitoring that will be through the PSE, in which this scale will be printed in banner form and affixed next to the physical education teacher during the classes.
15946276|NCT03293043|Device|NPV-EVLP|Lungs deemed marginal based on standard lung donor criteria that meet study eligibility will be physiologically assessed during ex-vivo perfusion. NPV-EVLP of these lungs will be performed with the addition of numerous pre-determined additives. With respect to the decision of lung utilization post-EVLP, eligibility criteria listed in the Post-NPV-EVLP section of the trial will need to be met. Lungs will also be excluded if they are deemed unsuitable based on the clinical judgment of the lung transplant surgeon.
15946277|NCT03293030|Drug|Dupilumab|Dupilumab treatment
15946278|NCT03293017|Drug|Diazepam 10 MG|If a patient's linical Institute Withdrawal Assessment (CIWA-ar) is more than 15 and did not decrease with 4 points compared to the previous score, they will be given oral diazepam to supress their symptoms, in a tablet of 10 mg.
15946279|NCT03293017|Drug|Baclofen 30mg|Baclofen 30 mg/day given over three gifts daily
15946280|NCT03293017|Drug|Baclofen 60mg|Baclofen 60 mg/day given over three gifts daily
15946281|NCT03293004|Dietary Supplement|Hydrolyzed collagen|Escalating dose of Hydrolyzed collagen
15946282|NCT03293004|Dietary Supplement|Vitamin C|Escalating dose of Vitamin C
15946283|NCT03293004|Dietary Supplement|Optimized Hydrolyzed Collagen and Vitamin C|combination of optimized doses of Hydrolyzed Collagen and Vitamin C
15946284|NCT03293004|Dietary Supplement|Gummy Placebo|Gummy placebo
15946285|NCT03292978|Dietary Supplement|probiotics intervention|The probiotics intention is provided with 4 strains of probiotics as a 2g sachet powder, dried with corn starch for 4 weeks.
15946286|NCT03292978|Dietary Supplement|non-probiotic control|The placebo is corn starch alone provided and the shape, color, flavor and taste are same with the powder of probiotics intervention.
15946287|NCT03292965|Drug|Neostigmine|Referring to the randomisation allocation program, participants allocated to group neostigmine, administrate neostigmine as reversal
15946288|NCT03292965|Drug|Sugammadex|Referring to the randomisation allocation program, participants allocated to group sugammadex, administrate sugammadex as reversal
15946289|NCT03292952|Drug|KP415 oral capsule|Daily dose
15946290|NCT03292952|Drug|Placebo oral capsule|Daily dose
15946291|NCT03292939|Diagnostic Test|A complete Doppler ﬂow assessment of the maternal and fetal circulation|A complete Doppler ﬂow assessment of the maternal and fetal circulation was conducted by an independent investigator blinded to the treatment, 48 hours after receiving 400mg of vaginal progestrone .Voluson E8 (GE Healthcare, Zipf, Austria) ultrasound machine ,equipped with a 3.5-MHz curvilinear abdominal transducer with color imaging capabilities, was used in all cases.
15946292|NCT03292926|Drug|Bupivacaine|Bupivacaine will help treat pain and sensation after ACL repair
15946293|NCT03292926|Device|Ultrasound|Ultrasound will guide anesthesiologist in performing the different nerve blocks
15946294|NCT03292926|Drug|Dexamethasone|Dexamethasone will be used to prolong block duration
15946295|NCT03292913|Behavioral|Positive Health Check|PHC is an online intervention that delivers tailored evidence-based prevention messages to HIV positive patients through a series of brief interactive videos designed to simulate a conversation with an HIV primary care provider.
15946296|NCT03292913|Behavioral|Standard of Care|Standard of care for patients with HIV (this includes standard of care practices around ART initiation, adherence and retention)
15946297|NCT03292874|Diagnostic Test|high resolution MRI (hrMRI)|high resolution MRI (hrMRI) and standard MRI (sMRI) will be obtained at baseline and again in approximately 1 year in patients on prostate cancer active surveillance.
15946303|NCT03292848|Drug|Brexpiprazole|Tablet
15946304|NCT03292835|Device|LeiProtect®|Filmogenic dressing gel
15946305|NCT03292822|Dietary Supplement|Licochalcone A|Licochalcone A is a chalconoid, a type of natural phenols. It can be isolated from root of Glycyrrhiza glabra (liquorice) or Glycyrrhiza inflata. It shows antimalarial, anticancer, antibacterial and antiviral (specifically against influenza neuraminidase) properties in vitro.
15946306|NCT03292822|Drug|Paclitaxel|chemotherapeutic drug
15946307|NCT03292809|Drug|CyclASol topical ocular, eye drops|Cyclosporine A solution in vehicle
15946308|NCT03292809|Drug|Vehicle topical ocular, eye drops|Vehicle
15946309|NCT03292796|Drug|Prostaglandins|
15946310|NCT03292783|Drug|NOV1501 (ABL001)|VEGF/DLL4 targeting bispecific antibody
15946311|NCT03292770|Device|Flushing Catheter|A catheter will be used to performed a flushing of the cervical canal with culture media.
15946312|NCT03292757|Drug|Indocyanine Green|Fluorescent dye - indocyanine green
15946313|NCT03292744|Drug|Alfacalcidol|alfacalcidol 0,5 mcg
15946314|NCT03292731|Drug|Hydroxyprogesterone 250 Mg|Pregnant subjects randomized to this study arm will receive a weekly Intramuscular injection of 250mg hydroxyprogesterone caproate injection weekly from 16 0/7 to 36 6/7 weeks or delivery which ever is first.
15946315|NCT03292731|Drug|hydroxyprogesterone 500mg|Pregnant subjects randomized to this study arm will receive a weekly Intramuscular injection of 500mg hydroxyprogesterone caproate injection weekly from 16 0/7 to 36 6/7 weeks or delivery which ever is first.
15946316|NCT03292718|Device|MyCyFAPP|use of the MycyFAPP with all its features during 6 months
15946317|NCT03292705|Behavioral|PEP|The PEP system is built on a picture-based touch-screen interface on tablet computers. PEP allows users to explore and participate in entertainment, educational, spiritual, and other recreational activities and content personalized according to their interests and preferences. It provides easy access to the Internet and communication applications, and has hundreds of modules spanning music, travel, trivia, games, and religious and inspirational domains. For instance, if music is among a person's lifelong interests, the system provides access to multiple music genres through jukebox, karaoke and therapeutic music applications that can be tailored to a particular activity and by individual interest (for instance, a preference for classic jazz). As another example, for someone who likes travel or visiting new places, the interface offers access to Google Earth, guided tours, slide shows and regional facts and history.
15946318|NCT03292705|Behavioral|CCI|VSOP training will use five training paradigms (Eye for detail, Peripheral challenge, Visual sweep, Double decision, Target tracker) that practice processing speed and attention. All exercises share visual components and focus on accuracy and fast reaction times. Participants respond either by identifying what object they see or where they see it on the screen. The training will automatically adjust the difficulty of each task based on the participant's performance, ensuring that the participants always operate near their optimal capacity. The training programs will automatically record the percentage of completion of each game and scores.
15946319|NCT03292692|Behavioral|OurRelationship|Online intervention with coach support
15946320|NCT03292679|Procedure|3D template|"A 3D-printed model of relevant portions of the patient's facial skeleton, based on patient's CT scan will be created. This model will be used to bend titanium reconstruction plates that are used to stabilize the facial fracture for subjects in the treatment group.
~Bending of the plates will be performed in the operating room during the patient's surgery. Titanium reconstruction plates are used to stabilize the fracture whether or not the individual is in the study. However, for patients that are in the treatment arm of the study, the plates are bent with the aid of the 3D-printed model as template, rather than by free-hand."
15946325|NCT03292640|Drug|DFD-03 (0% tazarotene) Lotion (Placebo)|DFD-03 Vehicle Lotion (0% tazarotene) - twice daily application
15946326|NCT03292627|Device|Portable Noninvasive Hemodynamic Monitor|A non-invasive monitor for estimating patient's heart contractility and cardiac output by the change of thoracic electrical bioimpedance.
15946327|NCT03292614|Diagnostic Test|Measurements of the postoperative refraction|"The Measurements of the postoperative refraction will be performed with the following devices:
~Autorefractor Keratometers:
~Mod. ARK-760A (NIDEK CO,LTD, Gamagõri, Japan /OCULUS, Wetzlar, Germany), Mod. ARK-560A (NIDEK CO,LTD, Gamagõri, Japan /OCULUS, Wetzlar, Germany) KR-1W (TOPCON, Willich, Germany) KR-800s (TOPCON, Willich, Germany)
~Manual Refractometer:
~Eye refractometer PR 60 or PR 50 (Rodenstock, Munich),
~Test device:
~iTrace (TraceyTechnologies, Houston, Texas, USA),
~Phoropter (Block-Optic, Model 11625B) Determination of subjective refraction for distance and near (reading distance)"
15946328|NCT03292601|Device|Cinch Smart Strap|"The study device is a small (with dimensions of 1.5 x 2 x 3/8 and weighing approximately 0.9-oz) Bluetooth-enabled and battery-powered monitor with Velcro strap that attaches to orthopaedic braces for scoliosis in place of the traditional strap and buckle. When the Velcro strap is tightened, the device measures tension in Newtons with the vector of force parallel to and away from the device, reflecting the pulling force required to keep the brace fitted on the patient."
15946329|NCT03292601|Other|Cinch Mobile App|The Cinch App allows patients and parents to track and edit treatment information, sync data from the Cinch Smart Strap, and view compliance data. The app connects via Bluetooth to the Cinch Smart Strap and allows patients and parents save and sync data from the device.
15946330|NCT03292588|Biological|Mepolizumab|"Mepolizumab administered every 4 weeks by subcutaneous injection at a dose of:
~100 mg for participants ≥12 years of age and
~40 mg for participants ages 6 to 11 years and weighing ≥40 kg.
~Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg.
~Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study."
15946331|NCT03292588|Drug|Placebo|"Placebo administered every 4 weeks by subcutaneous injection at a dose of:
~100 mg for participants ≥12 years of age and
~40 mg for participants ages 6 to 11 years and weighing ≥40 kg.
~Note: Participants 6 to 11 years of age and weighing ≥40 kg who were enrolled in the study under previous versions of the protocol and were initially assigned a 100 mg dose will have their dose reduced to 40 mg.
~Participants 11 years of age will increase to the 100 mg dose if they become age 12 years during the study."
15946332|NCT03292575|Drug|Anticoagulants|
15946333|NCT03292562|Device|Discontinue NCPAP after weaning pressures|After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2).
15946334|NCT03292562|Device|Discontinue NCPAP without weaning pressures|After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2).
15946335|NCT03292549|Procedure|Robotic partial surgery|Robotic partial surgery
15946336|NCT03292536|Drug|Merestinib|"*The merestinib does escalation timing will depend on the schedule of the other anticancer regimen*
~Subjects will receive merestinib 40mg PO Qday (dose level 1) for 2 to 4 weeks followed by 80mg PO daily (dose level 2) for 4 to 10 weeks"
15946337|NCT03292523|Other|questionnaire|Work Productivity and Activity Impairment (WPAI) Multidimensional Dyspnea Profile (MDP) Baseline Dyspnea Index (BDI), MOS-SF36, Hospital Anxiety Depression (HAD) Cognitive Failure Questionnaire (CFQ).
15946338|NCT03292510|Other|GO-OUT Group|Following a baseline assessment, eligible participants will be stratified by site, and randomly assigned to receive the 1-day educational workshop and 3-month outdoor mobility program (GO-OUT intervention). Follow-up evaluations will occur at 3, 5.5 and 12 months from baseline.
15946339|NCT03292510|Other|Workshop Group|the 1-day workshop plus reminders. Follow-up evaluations will occur at 3, 5.5 and 12 months from baseline
15946340|NCT03292497|Procedure|Treatment Algorithm|Patients will have their procedure dictated by a treatment algorithm. They will have their mitral valve replaced if the posterior leaflet tethering angle >=25 degrees, or repaired if the posterior leaflet tethering angle <25 degrees.
15946341|NCT03292497|Procedure|No Treatment Algorithm|Patients will have their valve repaired or replaced at the discretion of their surgeon.
15946342|NCT03292484|Biological|AR101|AR101
15946343|NCT03292471|Device|Transcranial Magnetic Stimulation|rTMS is a non-invasive brain stimulation technique in which a focal, time-varying magnetic field is applied to a specific brain area to induce neuronal depolarization. rTMS can be used to selectively target a given brain region with a resolution as focal as 0.5 cm3 .Typically, administering a slow (1 Hz) sequence of magnetic pulses via rTMS temporarily reduces cortical excitability in the targeted brain region.
15946344|NCT03292458|Drug|Sodium Oxybate|Alcohol challenge test and oral administration of a single dose of sodium oxybate and the matching placebo.
15946345|NCT03292445|Procedure|Immune tolerance after kidney transplant|Induction of immune tolerance after kidney and hematopoietic cell transplantation with a conditioning regimen of total lymphoid irradiation and anti-thymocyte globulin followed by immunosuppressive drugs for 18 months. Immunosuppressive drugs are stopped if stable chimerism is achieved and there is no kidney rejection.
15946346|NCT03292445|Drug|Donor blood stem cells and T cells|"Immune tolerance after kidney transplantation resulting from mixed blood cells chimerism will be induced by donor blood stem cells and T cells given to the kidney recipient. Donor cells will be collected by apheresis after mobilization of blood stem cells from bone marrow 6-8 weeks before kidney transplant. Collected cells will undergo CD34 selection to recover >10 million donor blood stem cells/kg of patient weight to be combined with up to 150 million donor T cells/kg for transfusion soon after kidney transplant. The IND for this study covers the infusion of donor blood stem cells."
15946377|NCT03292250|Drug|BYL719|Patients will be instructed to take BYL719 orally at a dose of 100 mg with a glass of water once daily, in a fasting state or with a light fat-free meal, and as close as possible to the same time each day.
15946989|NCT03287479|Procedure|Cryotop® Vitrification|An open, manual vitrification system
15946347|NCT03292432|Behavioral|TERA Intervention (TERA)|"A sequence of adherence support strategies implemented at care visits and as needed on the basis of EDM data. Components include: (1) remote education/preparation with an adherence coach conducted with VSee software (video conferencing) at site at baseline, week 4 and week 12; (2) one-way text alert at dose time when bottle has not yet been opened for that dosing window (users can disable this on request); (3) missed dose two-way outreach text asking What's the plan? which gets sent to both the participant's phone and a study phone; and (4) implementation of the coach-outreach (phone, text, remote counseling) triggered by missed doses or as a check-in to inquire about the well-being of the youth (once per week when no other contact with coach occurred the week prior)."
15946348|NCT03292432|Behavioral|Standard of Care (SOC)|Cell-phone reminders, patient-education, adherence planning (medication management), and checking-in on adherence at clinical care visits, as well as Viral load (VL) monitoring with patient feedback on VL, are used at sites. Less common, but available as a general service at some sites, on several websites, and at many pharmacies, youth may also receive text messages at dose times, for appointment reminders, and for refill reminders.
15946349|NCT03292419|Procedure|Topography-guided LASIK|LASIK surgery
15946350|NCT03292406|Drug|Placebo|Non active ingredients of CD11301
15946351|NCT03292406|Drug|CD11301 0.03%|Topical Gel
15946352|NCT03292406|Drug|CD11301 0.06%|Topical Gel
15946353|NCT03292393|Behavioral|Financial reward|In contingency management, financial rewards are contingent upon an individual changing behavior. In our study, financial incentives are contingent upon group behavioral changes.. In the intervention phase participants will be randomly assigned to one of the three treatment arms and they will receive the financial incentive that corresponds to their treatment arm. Data will be collected for four months and all participants will continue receiving a compensation for participation
15946354|NCT03292393|Behavioral|Social norms|To build social norms the study adds a group component to a contingency management model. In contingency management, financial rewards are contingent upon an individual changing behavior. Social norms are expected to emerge as a result of the designed group contingency management, monthly-facilitated meetings at a local clinic, and daily basis interaction through social media. The intervention will build social norms that improve medication adherence of each member of a group. A three-arm randomize trial is designed to test this hypothesis. Hypertensive patients will be randomly assigned to a group contingency management (GCM) arm, an individual contingency management (ICG) arm, or a control arm.
15946355|NCT03292393|Device|Home Blood Pressure Monitoring|Participants will be reminded that they will receive and learn how to use a Home Blood Pressure Monitor (HBPM) device that participant will keep for the duration of the study
15946356|NCT03292393|Device|Medication adherence assessment|Participants will be informed that they will receive and learn how to use eCap, a medication event monitoring system that participants will return after completing the study. The project nursing student will count the number of pills the participant currently has and make a record of it on the Data Collection form.The participant will provide the project nursing student with his/her antihypertension prescription records so that the dosage amount and number of pills can be recorded on the Data Collection form.
15946357|NCT03292380|Other|No intervention was included|
15946358|NCT03292367|Procedure|ldTRA|After puncture of left distal radial artery, coronary angiography and percutaneous coronary intervention, if needed, will be performed.
15946359|NCT03292354|Other|Contrast media administration|All patients will receive contrast media with a concentration of 300 mg I/mL (Iopromide 300). The flowrate and volume will be calculated with help of the different formulas belonging to the three different arms.
15946360|NCT03292341|Other|Interviews|Interviews with patients, physicians and general practitioners (GPs) to define patients' decisional needs
15946361|NCT03292341|Other|Treatmentchoice Decisional Tool|Patients and physicians navigate through Treatmentchoice Decisional Tool and think aloud while running the tool
15946362|NCT03292341|Other|Questionnaires|Patients and physicians fill out questionnaires on the usual care, Delphi study
15946363|NCT03292341|Other|Interviews with stakeholders|Interviews with stakeholders Interviews with stakeholders (patients, clinicians, nurses, GP's, patient organizations, insurance companies) to determine the barriers and facilitators to the implementation of shared decision making and the decision aid.
15946364|NCT03292328|Other|Yoga|Participants in the Yoga group will meet twice weekly for 8 weeks of classes taught by MSK yoga instructors. Each class will last for sixty minutes. In addition to these group classes, participants will utilize a home-based program on the days group classes are not held. The daily home practice will continue for four weeks after the group classes are finished.
15946365|NCT03292328|Other|Wait List Control|Participants in the WLC group will continue usual care for twelve weeks before participating in Yoga classes for eight weeks. At the end of the twelve week follow-up, these subjects will receive eight weeks of group Yoga classes and the home Yoga practice recording. At week 20, they will complete a final follow-up visit.
15946366|NCT03292315|Drug|Exenatide 2 MG Injection [Bydureon]|Once weekly injection of 2mg of Exenatide
15946367|NCT03292315|Other|No Intervention|No injection will be administered
15946368|NCT03292302|Drug|Placebo|Placebo comparator
15946369|NCT03292302|Drug|ELX-02|Synthetic aminoglycoside
15946370|NCT03292289|Procedure|Pre- and post-operative consultation|Before and between the two interventions
15946371|NCT03292289|Procedure|Stomatherapy consultation|Clinical exam. At one and six months after the 2nd intervention
15946372|NCT03292289|Procedure|Questionnaires|"QLQ-C30 and QLQ-CR29 at each time defined by the study (one month before and after the first intervention, before the 2nd intervention and at 1, 3, 6 and 12 months after the 2nd intervention)
~Stoma-QoL before and after the 2nd intervention
~LARS score at 1, 3, 6 and 12 months after the 2nd intervention"
15946373|NCT03292276|Device|Amadeo Training|"To understand the cortical modifications related to movement preparation and execution after robot-assisted training we will study the EEG modifications of cortical activity using time-frequency event-related EEG and task-related coherence (TRCoh).
~Friedman ANOVA with post-hoc t-test (corrected for multiple comparisons) will be used to assess the significance of training-induced changes in the two groups."
15946374|NCT03292263|Drug|Melphalan|iv infusion 70-100 mg/m2 on day -3, -2
15946375|NCT03292263|Drug|Nivolumab|iv infusion 100 mg on day -3, +17
15946376|NCT03292263|Procedure|Autologous Stem Cell Transplantation|peripheral blood stem cell transfusion at day 0
15946378|NCT03292250|Drug|Poziotinib|Patients will be instructed to take BYL719 orally at a dose of 12 mg once daily, in a fasting state or with a light fat-free meal, and as close as possible to the same time each day.
15946379|NCT03292250|Drug|Nintedanib|Initial dose 200 mg twice per day orally according to study protocol.
15946380|NCT03292250|Drug|Abemaciclib|Patients will be instructed to take Abemaciclib orally at a dose of 200mg bid with a glass of water twice daily, in a fasting state or with a light fat-free meal, and as close as possible to the same time each day.
15946381|NCT03292250|Drug|Durvalumab,Tremelimumab|Durvalumab: 1.5g Q4W plusTremelimumab: 75mg Q4W up to 4cycle then Durvalumab 750mg Q2W, till PD or unacceptable toxicity.
15946382|NCT03292237|Dietary Supplement|Supplemental parenteral nutrition|Supplemental parenteral nutrition OLIMEL N12E (Baxter Healthcare Corporation)
15946383|NCT03292224|Diagnostic Test|- Microscopic examination and culture of collected specimens|"Unstained wet mount with 10%-20% KOH.
~Wet mounts stained with:
~Lactophenol cotton blue.
~India ink
~Gram stain Culturing on Sabouraud´s dextrose agar ."
15946384|NCT03292211|Behavioral|early mobilization|early out-of-bed activities including supine to sit training, sit on the edge of bed without supporting, standing with hand supporting, stepping while standing etc.within three days after stroke while being monitored by medical equipment.
15946385|NCT03292211|Behavioral|early standard intervention|Conventional early in-bed activities within three days after stroke
15946386|NCT03292198|Other|20-30 mmHg compression sleeve and gauntlet|"Compression garments are Juzo Soft, circular knit. Most will be off-the-shelf sizing, but custom when necessary.
~Garment fittings will be performed by Certified Lymphedema Therapists."
15946387|NCT03292198|Other|Manual Lymphatic Drainage|"Manual Lymphatic Drainage (MLD) is a gentle skin-stretch massage that stimulates the lymphatic system and assists in creating collateral drainage pathways out of non-intact (damaged) lymphatic territories. MLD is a critical part of Complete Decongestive Therapy (CDT), which is accepted as the international standard of care in the treatment of lymphedema.
~The MLD sessions will be performed by 2 Certified Lymphedema Therapists, Megan Klote and Sarah Stolker, both trained through the Norton School of Lymphatic Therapy. The therapists have completed reliability meetings regarding MLD sequencing and techniques."
15946388|NCT03292185|Drug|insulin degludec/liraglutide|Insulin Degludec/Liraglutide combination product with 0.61 mg Liraglutide and 17 U Insulin Degludec, single dose administration under the skin in the thigh.
15946389|NCT03292185|Drug|insulin degludec|17 U Insulin Degludec, single dose administration under the skin in the thigh.
15946390|NCT03292185|Drug|liraglutide|0.6 mg Liraglutide, single dose administration under the skin in the thigh
15946391|NCT03292172|Drug|Atezolizumab|Atezolizumab will be given intravenously (IV) at a fixed dose of 1200 mg on Day 1 of each cycle, every 3 weeks.
15946392|NCT03292172|Drug|RO6870810|RO6870810 will be injected SC,at initial planned doses of 0.30, 0.45, or 0.65 mg/kg, QD for the first 14 days of a 21-day cycle.
15946393|NCT03292159|Device|Active RAVANS concurrent with arm motor training|Patient receives non-painful, sensory-level stimulation to the skin of left outer ear, where nerve endings of the auricular branch of the vagus nerve reside, while participating in arm motor training
15946394|NCT03292159|Device|Inactive RAVANS concurrent with arm motor training|Patient does not receive stimulation delivered to the skin of left outer ear while participating in arm motor training
15946395|NCT03292146|Drug|Denosumab 60 MG [Prolia]|Denosumab 60mg injection at baseline and 6 months
15946396|NCT03292146|Drug|Placebo Injection|Placebo Injection at baseline and 6 months
15946397|NCT03292146|Drug|Alendronate 70Mg Tab|Alendronate 70mg PO weekly starting at Month 12 through 24 months.
15946398|NCT03292133|Drug|EGF816|EGF816 is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplying
15946399|NCT03292133|Drug|Gefitinib|Gefitinib is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplying
15946400|NCT03292120|Other|measure of the SOFA score|The Sequential Organ Failure Assessment (SOFA) Score predicts ICU mortality based on lab results and clinical data.
15946401|NCT03292081|Device|OFDI|PCI under OFDI guidance
15946402|NCT03292081|Device|IVUS|PCI under IVUS guidance
15946403|NCT03292068|Combination Product|Acupuncture, acupressure|"Intervention group will receive usual care in combination with Pyonex-needles and Kulplåster. The control group will only receive usual care."
15946404|NCT03292068|Dietary Supplement|Timbal diet|Intervention group will receive usual care in combination Timbal diet including Protein-enriched ice cream, made with egg yolks and Cream. The control group will only receive usual care.
15946405|NCT03292068|Other|Extended telephone counseling|Intervention group will receive usual care in combination with Extended telephone counseling. The control group will only receive usual care.
15946406|NCT03292042|Behavioral|Physical health promotion program|"The program has 24 sessions. Each session has two parts:
~first part: half an hour of theoretical content, about the Metabolic syndrome, the effect of unhealthy lifestyle, toxic habits such as smoking or drinking alcohol, dietary habits or physical activity.
~Second part: 1 hour of physical activity (walk)"
15946407|NCT03292029|Diagnostic Test|T50 Calcification Inhibition Test (CIT)|Measurement of predialysis T50 CIT and fetuin-A values in serum of hemodialysis patients
15946408|NCT03292016|Drug|APL-130277|APL-130277 sublingual thin film
15946409|NCT03292016|Drug|APO-go|Subcutaneous APO-go
15946410|NCT03292016|Drug|Apokyn|Subcutaneous APOKYN
15946411|NCT03292003|Device|Journey II BCS Total Knee System|
15946412|NCT03291990|Drug|Temozolomide|5 fraction hypofractionated stereotactic radiosurgery along with standard temozolomide
15946413|NCT03291977|Drug|Fluorescéine Sodique Faure|Fluorescéine Sodique Faure given intravenously during the induction of the anesthesia, at the dose of 3mg/kg, diluted in 50mL of physiological serum, in 10 minutes.
15946414|NCT03291977|Procedure|White-light surgery|The surgery will be performed under classical conditions
15946415|NCT03291964|Diagnostic Test|Rapid Brain MRI|Children undergoing head CT for evaluation of acute head injury will also undergo rapid brain MRI with GRE sequence that is specific for blood. Their clinical care will not change at all based on the MRI.
15946454|NCT03291678|Procedure|classic laparoscopic orchiopexy|delivery of abdominal testis into scrotum without closure of the internal ring of the inguinal canal
15946455|NCT03291652|Diagnostic Test|DSA/3DRA|DSA/3DRA
15946416|NCT03291951|Behavioral|Resistance training|The intervention goal is for study participants to exercise with progressively higher weights for resistance training to achieve a 1-kg increase in lean body mass by the end of the intervention. During an in-person visit on the same day as a chemotherapy infusion session, exercise professionals will teach participants a series of exercises to be completed at home twice weekly throughout the intervention. Participants will also receive protein powder, which they will be instructed to consume with meals twice a day. During subsequent infusion sessions, the exercise professional will meet in-person with participants to evaluate their ability to increase weights, and adjust exercises appropriately. In between visits, the exercise professional will check-in with participants by phone.
15946417|NCT03291938|Drug|Oxidative Phosphorylation Inhibitor IACS-010759|Given PO
15946418|NCT03291938|Other|Pharmacodynamic Study|Correlative studies
15946419|NCT03291938|Other|Pharmacokinetic Study|Correlative studies
15946420|NCT03291925|Procedure|Selective invasive angiography based on CT/CCTA imaging.|
15946421|NCT03291925|Procedure|Procedure/Surgery: Invasive angiography|
15946422|NCT03291912|Procedure|Chuna Manual Therapy|"Unique manual therapy in traditional Korean medicine
~Mandatory techniques for neck part and selective techniques for other part (if necessary)
~Selective techniques depends on a patient's condition (judged by traditional Korean medicine doctor)"
15946423|NCT03291912|Procedure|Usual care|"Physical therapy based on traditional Korean medicine theory
~Electrical stimulation: either Meridian muscle interferential current electricity or Meridian transcutaneous electricity
~Heat stimulation: either Hot pack or Infrared lamp
~Patient education
~Physical and pathological explanation of cervicogenic dizziness
~Cause and risk factors of cervicogenic dizziness
~Functions of muscles related to cervicogenic dizziness
~Home exercising to self-manage cervicogenic dizziness"
15946424|NCT03291899|Combination Product|FOLFIRINOX|combination chemotherapy using Oxaliplatin, Irinotecan, Leucovorin and Fluorouracil, given every 15 days for a total of 12 cycles
15946425|NCT03291886|Drug|Entinostat|Given PO
15946426|NCT03291886|Drug|Entinostat(Placebo)|Given PO
15946427|NCT03291886|Drug|Exemestane|Given PO
15946428|NCT03291873|Procedure|PRK|PRK using Alcon-Wavelight Excimer Laser EX 500
15946429|NCT03291860|Procedure|Ovum retrievum|assessment of oocytes collected by ovum retrievum to evaluate the discriminatory power of the antimullerian hormone in ICSI cycles
15946430|NCT03291847|Device|fetal monitoring|Maternal fetal monitoring
15946431|NCT03291847|Drug|Buprenorphine Naloxone|Treatment for opioid use disorder
15946432|NCT03291847|Drug|Methadone|Treatment for opioid use disorder
15946433|NCT03291821|Drug|human menopausal gonadotropin|human menopausal gonadotropin subcutaneously
15946434|NCT03291821|Drug|GnRH antagonist|GnRH antagonist subcutaneously
15946435|NCT03291821|Drug|GnRH analog|GnRH analog subcutaneously
15946436|NCT03291821|Procedure|Trophectoderm biopsy|Trophectoderm biopsy is the process of removing few cells from an in vitro fertilization embryo.
15946437|NCT03291821|Diagnostic Test|MitoScore|The cells removed from an in vitro fertilization embryo during the trophectoderm biopsy will be used to assess the mitochondrial DNA content as a viability indicator in the euploid embryos.
15946438|NCT03291821|Procedure|Intracytoplasmic sperm injection|ICSI is an in vitro fertilization procedure in which a single sperm is injected directly into an oocyte.
15946439|NCT03291821|Procedure|Ovarian puncture|Egg retrieval is a simple procedure. It is performed in an operating room for safety reasons. It is performed vaginally and involves aspirating the follicular fluid through a thin needle. Embryologists then retrieve from this fluid the eggs that have matured during stimulation. It lasts for 5 to 15 minutes, and a mild sedative is administered to prevent any kind of pain during the procedure.
15946440|NCT03291821|Diagnostic Test|Preimplantation genetic test|The cells removed from an in vitro fertilization embryo during the trophectoderm biopsy will be tested for chromosomal normalcy before transferring the embryo to the uterus.
15946441|NCT03291821|Procedure|Embryo transfer|Embryo transfer refers to a step in the process of assisted reproduction in which embryos are placed into the uterus
15946442|NCT03291821|Diagnostic Test|Pregnancy test|A pregnancy test is used to determine whether a woman is pregnant.
15946443|NCT03291821|Procedure|Embryo freezing|Embryo freezing is a method for cryopreserving embryos.
15946444|NCT03291821|Procedure|Embryo thawing|Embryo thawing is the procedure to recover previously frozen embryos prior to an embryo transfer.
15946445|NCT03291808|Behavioral|Weight loss intervention|"This 6-month intervention will include restricted calorie intake and increased physical activity. Key behavioral strategies to facilitate changes in dietary habits and activity patterns will be introduced, promoted and reinforced throughout the program. Weekly group meetings in a synchronous chat (i.e., in real time) led by a facilitator will be the venue for the group process. Extensive web-based resources to support behavior changes will be offered. Group chat sessions will meet online weekly for 6 months."
15946446|NCT03291795|Other|Exercise Intervention|Study patients will undergo a program of prehabilitation exercise for 6 days per week prescribed for them by an exercise physiologist, for up to 4 weeks prior to surgery.
15946447|NCT03291782|Drug|D-0120|oral, single dose
15946448|NCT03291743|Device|Capsule endoscopy|PillCam(TM) CROHN'S CAPSULE
15946449|NCT03291730|Behavioral|Breathing and journaling exercise|May help reduce anxiety of receiving chemotherapy
15946450|NCT03291730|Other|Art-therapy|May help reduce anxiety of receiving chemotherapy
15946451|NCT03291717|Behavioral|Bridging Community Gaps Photovoice (BCGP)|Participants assigned to this group will be part of the 6-month long BCGP intervention, which involves a 12- week class that meets weekly, followed by three booster sessions - one per month in the three months following the class, and up to 24 sessions of individual support as needed throughout the 6 months provided on a weekly basis either in person or by phone. The BCGP classes follow a manualized curriculum with sessions that combine didactic information, Photovoice exercises, and group discussions to empower participants in pursuing community participation goals, all refined with input from individuals with a lived experience.
15946452|NCT03291704|Device|Thermal therapy device|Thermal therapy of blocked Meibomian glands
15946453|NCT03291678|Procedure|new laparoscopic orchiopexy|closure of the internal ring of the inguinal canal after descending of the testis to scrotum using needle percutaneous
15946990|NCT03287466|Drug|Oxygen|targeted oxygen therapy
15946456|NCT03291613|Other|Pinpoint App|Tablet app with pain assessment and communication education, and pain assessment tool.
15946457|NCT03291600|Behavioral|Virtual Psychiatric Care|Virtual psychiatric care for perinatal depression will be offered to participants, in addition to care as usual, for a 12-week period by their treating perinatal psychiatrist. Virtual care will be delivered by video-based visits through the Ontario Telemedicine Network (OTN). The treating psychiatrist may request that an intervention group participant present for in-person care at any visit, and this may include need for behavioural activation, or another health-related indication at the discretion of the treating psychiatrist.
15946458|NCT03291587|Other|Key Informant|Each site will have a coaching team: two members of our research team including an expert in tobacco cessation and an expert in lung cancer screening. Active coaching includes six, 1-1 ½ hour video exchanges among program sites and coaching teams, once every 4-6 weeks over an 8-month implementation phase. One week prior to the call, each site will be prompted with an email to inform the coaching team of any challenges associated with implementation.
15946459|NCT03291574|Procedure|Electroacupuncture|Acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu.
15946460|NCT03291574|Procedure|Sham electroacupuncture|Sham acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu.
15946461|NCT03291561|Procedure|Electroacupuncture|Acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu.
15946462|NCT03291561|Procedure|Sham electroacupuncture|Sham acupuncture at Baihui, Nei guan, bilateral Zu sanli and bilateral Tian shu.
15946463|NCT03291548|Dietary Supplement|Quinoa biscuit|2x15g biscuits per day for 28 consecutive days (4 weeks).
15946464|NCT03291548|Dietary Supplement|Control biscuit|2x15g biscuits per day for 28 consecutive days (4 weeks).
15946465|NCT03291535|Other|Connected-device|This intervention will allow patients to upload blood pressure data automatically from a blood pressure cuff into the electronic health record.
15946466|NCT03291535|Other|Usual care|This intervention will consist of usual clinical care as determined by the clinical pharmacist.
15946467|NCT03291522|Procedure|Ultrasound-guided rete testis flushing and aspiration|Ultrasound-guided rete testis flushing and aspiration is performed first. If no sperm is found, the patient can choose to do a standard of care procedure (but not required).
15946468|NCT03291509|Behavioral|Video Conference Meetings|Individual video conferencing with a health educator using an iPad.
15946469|NCT03291509|Behavioral|In-person Meetings|Individual face-to-face (FTF) meetings with a health educator.
15946470|NCT03291509|Behavioral|Enhanced Stop Light Diet|Diet composed of healthy, pre-packaged meals, balance of fruits, vegetables, and low calories snacks, and shakes. Participants and study partners will be trained to use a color coded chart which categorize foods based on the Stop Light system (green, yellow, red) to assist in meal planning, grocery shopping, decisions regarding snack foods, and compliance with the diet in special situations such as eating away from home (restaurants, parties, etc.).
15946471|NCT03291509|Behavioral|Physical Activity|Participants will be asked to complete a set amount of time of moderate-to-vigorous physical activity each week. Participants in the Computer group will be asked to attend remote exercise sessions 2 times a week.
15946472|NCT03291496|Other|Blood Collection Preterm|Blood will be collected on day 4 of life and then approximately every 3 days until 21 days of life. Thereafter, one sample will be collected weekly until discharge. For preterm neonates that have suspected sepsis an additional sample will be collected within 24-48 hours of the initial sepsis evaluation.
15946473|NCT03291496|Other|Blood Collection Term|A single 250 µl blood sample will be collected once the term neonate is >24 hours old.
15946474|NCT03291496|Other|Adult Blood collection|One Time 1 ml of whole blood collected
15946475|NCT03291483|Other|whole body vibration|whole body vibration is a mechanical stimulus characterized by oscillatory movements.Whole body vibration's potential beneficial effects occurs by transmission of mechanical and sinusoidal vibrations to the whole body through the feet.
15946476|NCT03291483|Other|plyometric training|Plyometric exercises refers to performance of stretch-shortening cycle (SSC) movements that involve a high-intensity eccentric contraction immediately after a rapid and powerful concentric contraction.
15946477|NCT03291470|Biological|TG-C|2 mL injection of allogeneic human chondrocytes expressing transforming growth factor-beta1
15946478|NCT03291470|Biological|Placebo Control|2 mL normal saline injection
15946479|NCT03291457|Drug|Tocilizumab|For intravenous (IV) tocilizumab, the recommended dosage is 8 milligrams per kilogram (mg/kg) once every 4 weeks. For subcutaneous (SC) tocilizumab, the recommended dosage is 162 milligrams (mg) once weekly. However, because of the observational nature of the study, dosing and treatment duration is at the discretion of the physician in accordance with local clinical practice and local labeling.
15946480|NCT03291457|Drug|Glucocorticoid Agent|Because of the observational nature of the study, the choice of glucocorticoid agent, as well as dosing and treatment duration, is at the discretion of the physician in accordance with local clinical practice and local labeling.
15946481|NCT03291444|Biological|Chimeric antigen receptor T cells|After pretreatment, chimeric antigen receptor T cells will be transfused.
15946482|NCT03291444|Biological|peptide specific dendritic cell|After transfusion of chimeric antigen receptor T cells, Eps8 or WT1 peptide specific dendritic cell were intradermal injected.
15946483|NCT03291431|Device|Intermittent theta burst transcranial magnetic stimulation|Participants will be randomized to active or sham iTBS conditions, and receive 20 iTBS sessions over the course of 2 weeks
15946484|NCT03291418|Drug|ATB-346 OR Placebo|Comparison of gastrointestinal effects
15946485|NCT03291418|Drug|Naproxen sodium|Comparison of gastrointestinal effects
15946486|NCT03291392|Genetic|Gene expression or biomarkers exploration|
15946487|NCT03291379|Drug|BTG-002814|BTG-002814 containing 100 mg vandetanib
15946488|NCT03291366|Drug|UCMSCC|infusion of aUCMSC and conventional therapy
15946489|NCT03291366|Drug|conventional treatment|conventional treatment
15946490|NCT03291353|Drug|pembrolizumab|200 mg IV given every three weeks
15946491|NCT03291327|Dietary Supplement|Probiotics|Lozenges for Home use
15946492|NCT03291314|Drug|Axitinib|1. Axitinib, a VEGFR-specific small molecule tyrosine kinase inhibitor (Tki) has demonstrated anti-tumor activity when evaluated as a mono-therapy and in combination with lomustine for the treatment of patients with recGB (EudraCT 2011-000900-16) [7].
15946493|NCT03291314|Drug|Avelumab|2. Avelumab (MSB00107; anti-PD-L1) is a fully human anti-PD-L1 IgG1 monoclonal antibody (mAb) that has demonstrated anti-tumor activity in several tumor types.
15946494|NCT03291301|Behavioral|Cognitive Behavioral Therapy for Insomnia|Cognitive Behavioral Therapy for Insomnia including psychoeducation, sleep restriction, stimulus control, cognitive restructuring, and relaxation.
15946495|NCT03291301|Other|Acupressure|Acupressure, a non-invasive therapy, is commonly used in Traditional Chinese Medicine
15946496|NCT03291288|Drug|Tolbutamide|Commercially available tolbutamide
15946497|NCT03291288|Drug|Midazolam|Commercially available midazolam
15946498|NCT03291288|Drug|Pexidartinib|Pexidartinib is formulated as opaque, white, 200-mg capsules
15946499|NCT03291275|Other|Follow-up for death and recurrence|All patients are followed up to determine definite date of diagnosis, recurrence and death.
15946500|NCT03291262|Other|Follow up for death and recurrence|Patients are followed up to determine the specific date of diagnosis, recurrence and death.
15946501|NCT03291249|Drug|Foralumab|Anti CD3 mAb
15946502|NCT03291249|Other|placebo|Placebo oral solution
15946503|NCT03291249|Drug|Omeprazole 20mg|Omeprazole is a proton pump inhibitor used to neutralize stomach PH
15946504|NCT03291236|Other|Follow-up for death and recurrence of patients|All patients are follow-up to determine specific date of diagnosis, recurrence and death.
15946505|NCT03291210|Other|normal inspired oxygen fraction|receives inspired oxygen fraction of 0.3
15946506|NCT03291210|Other|high inspired oxygen fraction|receives inspired oxygen fraction of 0.8
15946507|NCT03291197|Drug|Suprascapular and median nerve blocks|Ultrasound guided injection of the median and suprascapular nerve of the affected side.
15946508|NCT03291184|Device|peripheral neuromuscular monitor|Residual paralysis can only be measured by neuromuscular transmission monitoring of a peripheral nerve, typically the ulnar nerve innervating the adductor pollicis muscle.
15946509|NCT03291171|Behavioral|MyPlan 2.0|MyPlan 2.0 consists of five sessions. During these five sessions the following behaviour change techniques are used to motivate users to be more physically active or to sit less: exploring risk perceptions and perceived benefits, exploring social support, providing feedback, action planning, coping planning and monitoring.
15946510|NCT03291158|Drug|Minocycline|Subjects will be assigned into 5 cohorts of 5 subjects each, who will receive six doses of Minocin IV every 12 hours, starting on Day 1. Each dose of Minocin IV will be administered as an IV infusion over 1 hour. Subjects will be assigned to cohort based on time of bronchoalveolar lavage.
15946511|NCT03291145|Drug|Beta Blockers|With and without Beta Blockers
15946512|NCT03291145|Drug|Spironolactone|Brisk Standing before and after seven days treatment with Spironolactone
15946513|NCT03291132|Other|training camp|"The Smoke-free teens will join a 2-Day-1-Night training camp in July or August. The camp will cover a wide range of indoor, outdoor, adventure-based, experiential learning activities. Besides, the teens will be equipped with the knowledge on smoking hazards, tobacco control and smoking cessation. The teens will be taught how to deliver a brief smoking cessation intervention using the AWARD Model: By the end of the training camp, the teens should be confident and competent in delivering the brief smoking cessation intervention to smokers. The teens will then break down into groups to organize smoke-free programmes in their schools or in the community.
~All Smoke-free Teens will be invited to respond to the structured questionnaire at baseline (T1), immediately after the training camp (T2), and 3 (T3) and 6 months later (T4). Each group of teens will have to submit the written proposal and final report regarding the smoke-free programme to COSH at 3 (T3) and 6 (T4) months."
15946514|NCT03291106|Diagnostic Test|immunohistochemical staining|immunohistochemical staining for MLH1, MSH2, MSH6 and PMS2
15946515|NCT03291106|Diagnostic Test|tests of microsatellite instability|microsatellite instability in tissues of endometrial cancer
15946516|NCT03291106|Diagnostic Test|clinical criteria of Lynch syndromes|Amsterdam I or II criteria and Bethesda criteria
15946517|NCT03291106|Diagnostic Test|sequencing for mismatch repair genes|next-generation sequencing, Sanger method or qPCR for mismatch repair genes (MLH1, MSH2, MSH6, PMS2, and EPCAM)
15946518|NCT03291093|Drug|18F-Flutemetamol PET/MRI|All patients will undergo a PET/MRI of the carotids after 18F-Flutemetamol injection.
15946521|NCT03291067|Drug|MT-8554 Low dose|MT-8554 Low dose QD, oral, 12 weeks
15946522|NCT03291067|Drug|MT-8554 Medium dose|MT-8554 Medium dose QD, oral, 12 weeks
15946523|NCT03291067|Drug|MT-8554 High dose|MT-8554 High dose QD, oral, 12 weeks
15946524|NCT03291067|Drug|Placebo|Placebo QD, oral, 12 weeks
15946525|NCT03291054|Drug|Pembrolizumab|Subjects will receive pembrolizumab 200 mg (flat dose) IV every 3 weeks on day 1 of a 21 day cycle.
15946526|NCT03291054|Drug|Epacadostat|Epacadostat will be dosed at 100 mg PO twice a day (BID) daily. Doses should be taken twice daily, in the morning and evening, approximately 12 hours apart, without regard to food.Doses will be self-administered, except on Cycle 2 Day 1, when the morning dose will be given at the study site clinic. Subjects will be required to keep a pill diary that will be provided to them.
15946527|NCT03291041|Drug|Tasimelteon|capsule
15946528|NCT03291041|Drug|Placebo|capsule
15946529|NCT03291028|Biological|Immune checkpoint inhibitor targeting PD1|RCC and UC patients treated with immune checkpoint blockade
15946530|NCT03291015|Device|radiographic|using plain x ray to determind the treatment plan
15946531|NCT03291015|Device|arthroscopy|using wrist arthroscopy to determind the treatment plan
15946532|NCT03291002|Biological|CV8102|CV8102 alone
15946533|NCT03291002|Biological|CV8102 + anti-PD-1 therapy|CV8102 in combination with standard of care anti-PD-1 therapy
15946534|NCT03290976|Other|Acupuncture|"Acupuncture treatments will be patient-tailored, with the acupuncture points (acu-points) to be selected by the acupuncturist at each treatment session, in accordance with the dynamic of the patient's symptoms, concerns and expectations. At the same time, acupuncturists will be required to choose at least 5 of the following 11 acupoints, which are to be incorporated into their treatment regimen:
~Lower limb points: Liver (LIV) 3, Spleen (SP) 4, SP6, Stomach (ST) 36, Gallbladder (GB) 34, Kidney (KID) 3, LIV8, Web (Bafeng) points Upper limb points: Large Intestine (LI) 4, LI 11, LI10, Pericardium (PC) 6, Triple Warmer (TW) 3/4/5"
15946535|NCT03290976|Other|"Multi-modality (Acupuncture plus)"|"A number of additional CIM treatment modalities will be added to the acupuncture treatment in this arm of the study, in accordance with the practitioners available at each of the participating study centers. These will include one of more of the following:
~Manual-movement therapies - e.g. acupressure/reflexology, self- and caregiver-practiced acupressure
~Mind-body therapies - e.g. relaxation/imagery method, Anthroposophic music therapy The multimodal CIM treatment regimen will be re-evaluated at each session, and adapted according to the concerns and expectations of the patients, as well as the recommendation of the treating CIM practitioner."
15946536|NCT03290963|Drug|Lithium|Lithium will be dosed in units (LI level > or = 0.4 milliequivalents (mEq)/L)
15946537|NCT03290963|Drug|Placebo|Placebo tablets, dosed in units
15946538|NCT03290963|Drug|Ketamine|All subjects will receive 3 IV ketamine infusions of 0.5mg/kg, over 100 min. over 7 days.
15946539|NCT03290950|Drug|daratumumab|Cycle 1 ONLY: Daratumumab 16 mg/kg days 1, 8, 15, and 22, Cycle 2: Daratumumab 16mg/kg days 1, 8, 15, and 22; Cycles 3-6: Daratumumab 16mg/kg days 1 and 15, Cycles 7-8: Daratumumab 16mg/kg day 1; Daratumumab rate of infusion is per MSKCC guidelines.
15946540|NCT03290950|Drug|carfilzomib|Cycle 1 ONLY: Carfilzomib 20 mg/m2 per dose, days 2 and 3; Carfilzomib 36 mg/m2 per dose, days 8, 9, 15, and 16; Cycles 2-8: Carfilzomib 36 mg/m2 per dose, days 1, 2, 8, 9, 15, and 16
15946541|NCT03290950|Drug|lenalidomide|Cycle 1 ONLY: Lenalidomide 25 mg/day, days 2-21 every 28 days; Cycles 2-8: Lenalidomide 25 mg/day, days 1-21 every 28 days
15946542|NCT03290950|Drug|dexamethasone|Cycle 1 ONLY: Dexamethasone 20 mg/dose, days 2, 3, 8, 9, 15, 16, Cycles 2: Dexamethasone 20mg/dose, days 1, 2, 8, 9, 15, 16 and 22; Cycles 3-4: Dexamethasone 20mg/dose, days 1,2,8,9,15 and 16, Cycles 5- 8: Dexamethasone 10mg/dose, days 1, 2, 8, 9, 15, and 16
15946543|NCT03290950|Drug|dexamethasone|Cycle 1 ONLY: Dexamethasone 20 mg/dose, days 1, 2, 22; 40 mg/dose days 8 and 15, Cycles 2: Dexamethasone 40mg/dose, days 1, 8, 15; 20 mg/dose day 22, Cycles 3-4: Dexamethasone 40mg/dose, Days 1, 8 15, Cycles 5-8: Dexamethasone 20mg/dose, Days 1, 8, 15
15946544|NCT03290937|Biological|Cetuximab|Given IV
15946545|NCT03290937|Drug|Irinotecan Hydrochloride|Given IV
15946546|NCT03290937|Other|Pharmacodynamic Study|Correlative studies
15946547|NCT03290937|Biological|Utomilumab|Given IV
15946548|NCT03290924|Behavioral|Low dose high frequency health worker training approach|"Two 4-day training sessions for skilled birth attendants
~1-day peer practice coordinator training after first training session
~Weekly, peer-led practice sessions using MamaNatalie® and NeoNatalie™ anatomic models
~SMS reminder messages and quizzes
~Routine telephone calls between master mentors and peer practice coordinators, and between project staff and master mentors
~Health information officer training
~Data collection and use training
~Supply of simulators, newborn resuscitation equipment, and delivery sets"
15946549|NCT03290924|Behavioral|Active Comparison|Training on data collection and reporting
15946550|NCT03290898|Behavioral|High Intensity Interval Training|Training (HIIT)
15946551|NCT03290885|Combination Product|Combined contact aspiration/Stent Retriever Technique|Combined contact aspiration/SR is performed using a balloon-guide catheter (BGC). A 0.021 to 0.027 inch inner lumen microcatheter with a 0.014 to 0.016 inch micro-wire inside is introduced into a large-bore aspiration catheter and this construct is introduced into BGC. The BGC is placed into the origin of the cervical internal carotid artery (ICA). The catheter is advanced past the thrombus over the micro-wire to allow the SR deployment. The SR is deployed across the occlusion. Then the large bore distal access catheter is advanced to contact the proximal edge of the SR. The aspiration pump is connected to the large bore distal access catheter. After at least 90 sec, the SR and the large bore distal access catheter are pulled out as an unit from the BGC and the patient. Manual aspiration is also be applied to the BGC during the pull-out manoeuver which is performed after the temporary inflation of the balloon at the tip of the BGC to ensure flow arrest into the carotid
15946552|NCT03290885|Device|Stent retriever technique|"The technique used should be in accordance with the device instruction for use. A large bore balloon guide catheter has to be placed into the cervical ICA.
~A suitable delivery microcatheter is navigated over a micro-wire into the occluded major coronary artery MCA and across the occlusion. A control superselective angiogram may be used to document the extent of occlusion and thrombus. The stent retriever device is then deployed across the occlusion.
~After at least 90 seconds, removal should occur with proximal occlusion by inflation of the balloon guide catheter."
15946553|NCT03290872|Device|Carpentier Edwards Physio 2 Complete flexible mitral ring|Mitral valve Annuloplasty Ring repair using a Carpentier Edwards Physio 2 Complete flexible mitral ring
15946554|NCT03290872|Device|Simplici T Partial flexible mitral annuloplasty ring|Mitral valve Annuloplasty Ring repair using a Simplici T Partial flexible mitral annuloplasty ring
15946555|NCT03290859|Procedure|Titrate propofol monotherapy infusion to effect|Train anesthesia providers in a standardized protocol for titrating propofol infusion to effect.
15946556|NCT03290846|Drug|Secretin Human|Randomized, single-blinded secretin hydrochloride infusion.
15946557|NCT03290846|Drug|Saline Solution|Randomized, single-blinded saline infusion.
15946558|NCT03290846|Other|Cold exposure|All subjects will undergo a cold exposure PET scan.
15946559|NCT03290833|Device|Robotic|Participants will be placed in the robot and practice common hand tasks involving single finger range of motion exercise, grasping, and pinching objects.
15946560|NCT03290833|Other|Conventional therapy|An occupational therapist will provide one-on-one individualized programs focused on arm and hand function. Treatment will include function-oriented specific tasks, such as reach, grasp, transport and release of various objects between different targets.
15946561|NCT03290820|Radiation|Radiotherapy|Technique: intensity-modulated radiotherapy; Dose: GTVnx 6810cGy/30Fr, GTVnd 6400-6600cGy/30Fr, CTV1 6000cGy, CTV2 5400cGy.
15946562|NCT03290820|Drug|Concurrent chemotherapy|Nedaplatin 80mg/m2 d1+5-flurouracil 500mg/m2 d2-5, every 3 weeks; a total of 2-3 cycles.
15946563|NCT03290820|Drug|Aspirin|Daily aspirin of 75mg, from the starting date of radiotherapy.
15946564|NCT03290807|Device|SPECT/CT|Combined single photon emission computerized tomography and conventional computerized tomography (SPECT/CT) is a hybrid imaging modality, which combines a 3D bone scintigraphy (SPECT) and a conventional CT into one imaging procedure. The use of SPECT/CT offers the benefit of combined anatomical, mechanical (CT) and functional imaging (SPECT)
15946565|NCT03290794|Drug|Aflibercept (Eylea, BAY86-5321)|Intravitreal Aflibercept as prescribed by the treating Physician
15946566|NCT03290781|Drug|Ontamalimab|Participants will receive 1 milliliter (mL) of ontamalimab sterile aqueous buffered solution at an appropriate oncentration to provide an intended dose of drug (25 or 75 mg).
15946567|NCT03290781|Other|Placebo|Participants will receive 1 mL of sterile aqueous buffered solution.
15946568|NCT03290768|Device|Continuous Glucose Monitor (CGM)|Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.
15946569|NCT03290768|Device|Activity Tracker|Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.
15946570|NCT03290768|Behavioral|Coaching|Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.
15946571|NCT03290755|Behavioral|semi-directed interviews|semi-directed interviews in order to collect socio-behavioral data
15946572|NCT03290729|Procedure|wedge shape implants insertion|Narrow dental implants inserted in narrow ridges
15946573|NCT03290716|Other|SS|Replace regular salt with market available potassium-enriched salt substitute in kitchens of nursing homes.
15946574|NCT03290716|Other|SSSC|A stepwise approach to reduce salt used in the kitchen of nursing homes by controlling the supply of salt.
15946575|NCT03290703|Drug|GDC-0853|Participants will receive different formulations of GDC-0853 tablet.
15946576|NCT03290703|Drug|Rabeprazole|Participants will receive rabeprazole 20 mg twice daily (BID) for three days prior to GDC-0853 administration and a single dose coadministered with GDC-0853.
15946577|NCT03290677|Procedure|Cryoablation|This involves passing a special needle into the body (cryoprobe) to freeze tumor and kill a small part (not all) of the cancer. The immune system will respond to the damage caused by freezing part of the tumor.
15946578|NCT03290677|Procedure|Biopsy|Removing a small piece of the affected area to confirm cancer
15946579|NCT03290651|Dietary Supplement|Probiotic Natural Health Product - RepHresh Pro-B|Participants will take the probiotic or placebo daily for 90 days.
15946580|NCT03290651|Dietary Supplement|Placebo|Participants will take the probiotic or placebo daily for 90 days.
15946581|NCT03290638|Procedure|Guided Bone Regeneration (GBR)|Teeth Extraction With Bone Grafting and Membrane
15946582|NCT03290625|Drug|Dexmedetomidine Hydrochloride|Dexmedetomidine hydrochloride (PrecedexTM), presented in ampoule containing 2 mL of 100 mcg / mL solution for injection
15946583|NCT03290625|Drug|Ketamine Hydrochloride|Dextrocetamine hydrochloride (KetaminTM), presented in a 10 mL vial containing 50 mg / mL solution for injection
15946584|NCT03290612|Dietary Supplement|Vitamin C|1.5g Ascorbic Acid
15946585|NCT03290612|Other|Placebo|Inactive placebo to mimic 1.5g ascorbic acid.
15946586|NCT03290599|Other|Mini Mental and Modified Mini Mental Test|Mini Mental Test was used for literate patients and Modified mini mental test was used for illiterated patients
15946587|NCT03290586|Device|Flower Cube|single use, sterile disposable fixation construct
15946588|NCT03290573|Device|short peripheral venous catheter|short peripheral venous catheter for infusion therapy in adult patients
15946589|NCT03290560|Drug|Recombinant human tissue kallikrein|Recombinant human tissue kallikrein
15946590|NCT03290560|Other|Placebo|Placebo Comparator: Phosphate buffered saline
15946591|NCT03290547|Device|Cutera enLighten laser|Subjects will receive up to 10 laser treatments.
15946592|NCT03290534|Device|CivaSheet|implanting CivaSheet for localized radiation dose delivery
15946593|NCT03290521|Procedure|intraperitoneal washing with saline solution|intraperitoneal washing at the end of surgery
15946594|NCT03290521|Procedure|No washing|no washing
15946595|NCT03290508|Diagnostic Test|Prolaris Testing|Recently diagnosed treatment-naïve patients with early stage localized prostate cancer who undergo Prolaris testing
15946596|NCT03290495|Drug|ketamine|ketamine hydrochloride 250microgram/ ml for iv injection after 30 minutes of stable isoflurane anesthesia
15946597|NCT03290495|Drug|saline|a similar volume of normal saline 0.9% for intravenous injection instead of ketamine will be given to the control group. this because the attending anesthesiologist will be blinded to the study drugs and aim according to the study proposal.
15946598|NCT03290482|Diagnostic Test|Barium Esophagram|Fast for 4 hours prior to the Esophagram (upper GI x-ray). You will drink a liquid that has barium or another contrast agent in it. The radiologist will use the X-ray machine to look at your upper GI tract while you drink the contrast liquid. The x-ray exam should take between 10-15 minutes.
15946599|NCT03290482|Device|EsophaCap|Subjects will swallow the EsophaCap, which has a string attached, 10 minutes later it has devolved in the stomach. The PI will pull the string to remove the EsophaCap. We will send the sponge for cytology assessing the histologic results of eosinophils per high power field (phf)
15946600|NCT03290482|Diagnostic Test|Physical Examination and Questionnaires|Complete the modified Mayo dysphagia Questionnaire (MDQ) and the Eosinophilic Esophagitis Activity Index (EEsAI) at time of physical exam visit with PI.
15946601|NCT03290469|Other|clinical whole genome sequencing (cWGS)|Clinical Whole Genome Sequencing (cWGS) consists of the sequencing, analysis and interpretation of subjects samples and a return of the result to the ordering physician.
15946602|NCT03290456|Drug|Prednisone 5mg/day extended of 12 additional months|Prednisone 5mg/day orally during 12 Month + 1 mg/week tapering until 0mg.
15946603|NCT03290456|Drug|Placebo 5mg/day extended of 12 additionnal months.|1mg/week orally tapering Prednisone until Month 1 + Placebo orally 5mg/day until Month 13
15946604|NCT03290443|Drug|Enasidenib|100 mg enasidenib (CC-90007)
15946605|NCT03290430|Behavioral|Group Counseling|8 sessions over 4 weeks. Lasting 1-2 hours each
15946606|NCT03290430|Behavioral|Individual Counseling|8 in person sessions over 4 weeks. Lasting 30-45 minutes each
15946607|NCT03290430|Behavioral|Phone Counseling|8 phone sessions over 4 weeks. Lasting 30-45 minutes each
15946608|NCT03290430|Behavioral|Video Counseling|8 video call sessions over 4 weeks. Lasting 30-45 minutes each
15946609|NCT03290430|Behavioral|Texting support|Texts with smoking cessation support throughout the program
15946610|NCT03290430|Drug|Nicotine Replacement Therapy|Participants will receive up to 8 weeks of over-the-counter nicotine replacement therapy
15946614|NCT03290391|Other|Rapid ART initiation|The infectionist will streamline the approval with the ultimate goal of starting participants on ART while they are still hospitalized at the City Addiction Hospital.
15946615|NCT03290391|Drug|Pharmacotherapy for opioid use disorder|Thirteen months of naltrexone treatment for opioid use disorder (injection at baseline, followed by 4 implants).
15946616|NCT03290391|Behavioral|Strengths-based HIV case management|Strengths-based case management: 10 sessions over 12 months in which a trained case manager (CM) meets individually with patients to motivate them to engage in HIV medical care by supporting the recognition of their own strengths to make positive changes in their lives and ultimately improve their HIV outcomes.
15946617|NCT03290378|Drug|Tramadol|IV; 25 mg or 50 mg, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
15946618|NCT03290378|Other|Placebo|IV; Placebo, given at Hours 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, and 44
15946619|NCT03290365|Drug|platelet rich plasma + Hyaluronic acid|Platelet rich plasma (PRP) and Hyaluronic acid (HA) are beneficial for patients with osteoarthritis of knee.
15946620|NCT03290365|Drug|platelet rich plasma + normal saline|The normal salin as the placebo intervention was injection control group.
15946621|NCT03290352|Other|Questionnaire|Patients who enrolled in the study were asked to respond to the University of Washington Quality of Life Questionnaire one week before undergoing free flap reconstruction.
15946622|NCT03290339|Procedure|hysterectomy|laparoscopic hysterectomy and vaginal hysterectomy
15946623|NCT03290326|Device|Transcranial Alternating Current Stimulation (tACS)|tACS will be applied at a frequency of 40Hz and targeting the area of maximal tracer uptake on amyloid PET imaging using an individualized multielectrode design to maximize the induced electrical current to the target region.
15946624|NCT03290313|Drug|shu gan yi yang capsule|Patients who did not use any antidepressants were given normal clinical medication； Patients who have been treated with antidepressants have been treated for more than 1 month and have reached a therapeutic dose without having to adjust the drug and dose within 2 months.In the original treatment on the basis of the same type of load to the clinical trial medication
15946625|NCT03290313|Drug|shu gan yi yang capsule simulation agent|Patients who did not use any antidepressants were given normal clinical medication； Patients who have been treated with antidepressants have been treated for more than 1 month and have reached a therapeutic dose without having to adjust the drug and dose within 2 months.In the original treatment on the basis of the same type of load to the clinical trial medication
15946626|NCT03290313|Other|Supportive psychotherapy|Each patient was given cognitive behavioral adjustment and supportive psychotherapy during the clinical trial
15946627|NCT03290300|Device|Vivaer Stylus|Previous nasal obstruction treatment with the Aerin Medical Vivaer Stylus
15946630|NCT03290274|Device|Deep brain stimulation (fornix)|Deep brain stimulation at fornix
15946631|NCT03290274|Device|Deep brain stimulation (Basal nucleus of Meynert)|Deep brain stimulation AT Basal nucleus of Meynert
15946632|NCT03290261|Other|Hypnosis|3 hypnosis sessions performed at 4 - 6 weeks apart
15946633|NCT03290248|Biological|B244 suspension|B244 suspension in 30ml/bottle
15946634|NCT03290248|Biological|Vehicle|Vehicle, 30ml/bottle
15946635|NCT03290235|Drug|PEG-somatropin|Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/kit
15946636|NCT03290222|Other|TRACK questionnaire|TRACK questionnaire consists of five questions, scored 0-20, to be made to caregivers of children with asthma or recurrent respiratory symptoms, regarding respiratory symptoms, nocturnal awakenings and limitation of daily activities in the last four weeks, use of bronchodilators in the last three months and systemic corticosteroids in the last year
15946637|NCT03290209|Procedure|Laparoscopic D1 Lymphadenectomy|After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic D1 Lymphadenectomy will be performed in the experimental group.
15946638|NCT03290209|Procedure|Laparoscopic D2 Lymphadenectomy|After exclusion of T4b, bulky lymph nodes, or distant metastasis case, laparoscopic D2 Lymphadenectomy will be performed in the comparator group.
15946639|NCT03290196|Drug|EXPAREL 1.3 % in 20 ML Injection|EXPAREL single shot dose given as an analgesia for arthroscopic rotator cuff repair surgery.
15946640|NCT03290183|Device|Confocal laser endomicroscopy|Real-time microscopic imaging technique
15946641|NCT03290170|Procedure|Measured Resection|Bony landmarks are used to set femoral component rotation.
15946642|NCT03290170|Procedure|Gap Balancing|Relies on ligament releases prior to bone cuts.
15946643|NCT03290157|Device|ColoprAPP|Additional downloaded SPA for reminding the crucial steps of colonoscopy preparation
15946644|NCT03290131|Drug|Arbaclofen|Arbaclofen is the active R enantiomer of baclofen.
15946645|NCT03290131|Drug|Placebo|Placebo comparator
15946646|NCT03290118|Other|Nutrition Rating System - Traffic Light|Behavioural: Nutrition Rating Systems (shown on the online survey and the mobile app) provide consumers with an interpretation of the healthfulness of a food or beverage, by indicating the levels (low=green, moderate=amber, high=red) of sodium, saturated fat and sugar in a product based on modified Food Standards Australia New Zealand (FSANZ) criteria.
15946647|NCT03290118|Other|Nutrition Rating System - Health Star|Behavioural: Nutrition Rating Systems (shown on the online survey and the mobile app) provide consumers with an interpretation of the healthfulness of a food or beverage product by indicating the number of stars awarded to a product, from 0.5 to 5 stars, based on modified Food Standards Australia New Zealand (FSANZ) nutrient profiling criteria.
15946744|NCT03289429|Other|intravenous placebo|100 mL of isotonic saline (to be infused over 2 hours) twelve hours preoperatively, within the first hour of ICU arrival, and on the 2nd and 3rd postoperative days.
15946745|NCT03289429|Other|tablets placebo|Placebo tablets: twelve hours preoperatively, two hours preoperatively, and on the 2nd, 3rd, 4th and 5th postoperative days.
15946648|NCT03290118|Other|Nutrition Rating System - Warning Label|"Behavioural: Nutrition Rating Systems (shown on the online survey and the mobile app) provide consumers with an interpretation of the healthfulness of a food or beverage product by indicating with a warning label products that are high in sodium, saturated fat and sugar, based on a percent daily value (%DV) greater than 15% for individual products and 30% for combination dishes."
15946649|NCT03290118|Device|Smartphone application FoodFlip Device®|This is embedded within each condition to inform and educate consumers about the labelling condition/intervention to which they are randomized. All participants are assigned to an app task to view 20 products and see the 'rating' these products would get according to their condition.
15946650|NCT03290092|Drug|Taselisib (GDC0032)|The first six participants cohort receive a starting dose of 1mg once daily of taselisib during four weeks.
15946651|NCT03290092|Drug|Taselisib (GDC0032)|The starting dose of the second cohort of 24 patients is 2 mg once daily. This dose may be adjusted down according to the pharmacokinetic data or tolerability data derived from the first cohort.
15946652|NCT03290079|Drug|Pembrolizumab|200 mg Pembrolizumab by IV on Day 1 of each 3 week cycle.
15946653|NCT03290079|Drug|Lenvatinib|20 mg Lenvatinib by mouth every day of each 3 week cycle
15946654|NCT03290066|Device|kinesiotape|For the Kinesio taping group, a piece of Kinesio tape 5 cm in width and 7-8 cm in length will be applied right from below the navel and will reach to where the pubic hair begins, and another piece of tape 10 cm in length will be applied to make a cross shape with the first piece. A tape of 20cm in length will be placed horizontally to the lower back.
15946655|NCT03290066|Other|Usual care|Participants will note the usual self-care used to relief pain (NSAIDs, heat, massage therapy.....).
15946656|NCT03290053|Drug|SonoVue|SonoVue-infusion over 1 hour
15946657|NCT03290053|Drug|Sodium chloride|Placebo
15946658|NCT03290053|Procedure|Transcranial Ultrasound|Transcranial ultrasound aimed at the blockage
15946659|NCT03290053|Procedure|Sham Transcranial Ultrasound|Placebo - machine is attached, but not active
15946660|NCT03290027|Drug|DFD-03|DFD-03 Lotion
15946661|NCT03290027|Other|Placebo Comparator|Vehicle (tazarotene 0%) Lotion
15946662|NCT03290014|Diagnostic Test|polysomnography|Monitoring of brain activity and respiratory variables during sleep
15946663|NCT03290014|Diagnostic Test|Actigraphy|monitoring daily physical activity for 7 days
15946664|NCT03290014|Diagnostic Test|Osler test|Evaluation of subjects´ ability to remain awake
15946665|NCT03289988|Other|blood sampling|NK activity and gene panel expression analysis based on blood test (5cc blood sampling)
15946666|NCT03289975|Other|pulmonary ultrasound|Collect the aeration profile for each lung quadrant: profile A, profile B1, profile B2, profile C. Calculate the aeration score from O to 36 (LUS (Lung ultrasound) score).
15946667|NCT03289962|Drug|Autogene cevumeran|Autogene cevumeran will be administered by intravenous (IV) infusion, in 21-day cycles.
15946668|NCT03289962|Drug|Atezolizumab|Atezolizumab will be administered by IV infusion on Day 1 of every 21-day cycle.
15946669|NCT03289949|Drug|Psilocybine|Oral dose of psilocybine.
15946670|NCT03289949|Drug|Ketanserin|Oral dose of ketanserin.
15946671|NCT03289936|Device|NIPPV|Non invasive ventilation technique in which PIP and PEEP administration is not synchronized with newborn's respiratory efforts
15946672|NCT03289936|Device|SNIPPV|Non invasive ventilation technique in which PIP and PEEP administration is synchronized with newborn's respiratory efforts through an algorithm based on flow detection
15946678|NCT03289910|Drug|Carboplatin|Given IV
15946679|NCT03289910|Drug|Topotecan|Given IV
15946680|NCT03289910|Drug|Topotecan Hydrochloride|Given IV
15946681|NCT03289910|Drug|Veliparib|Given PO
15946682|NCT03289897|Diagnostic Test|LiverMultiScan|LiverMultiScan is an imaging technique which is able to identify early liver disease.
15946683|NCT03289884|Other|MRI scan (not involving ionising radiation)|The MRI study will be conducted by a trained MR radiographer, supervised by the nominated researcher
15946684|NCT03289884|Other|Ultrasound scan (not involving ionising radiation)|The US scan will be conducted by a nominated researcher
15946685|NCT03289884|Other|Ex vivo MRI scan of cyst fluid sample|The MRI study will be conducted by a trained MR radiographer, supervised by the nominated researcher
15946686|NCT03289884|Other|Aspiration of cyst fluid|For patients undergoing surgery/radiologically guided aspiration the aspiration will be performed by a surgeon (at the Royal Free Hospital) or radiologist
15946687|NCT03289884|Other|Blood test for confirmation of serum IgG levels consistent with hydatid infection|The blood sample will be drawn by a member of the clinical team
15946688|NCT03289871|Device|Excilor|
15946689|NCT03289871|Drug|Loceryl 5%|
15946690|NCT03289858|Drug|Exparel|Subcutaneous injection at conclusion of surgical fixation of hip fracture
15946691|NCT03289858|Drug|Sodium Chloride|Saline Injection
15946692|NCT03289845|Device|BHX implant (Bone anchored hearing system)|Bone anchored hearing system for hearing rehabilitation
15946693|NCT03289832|Dietary Supplement|Crucera-SGS|Crucera-SGS is a commercially available dietary supplement. The active ingredient is glucoraphanin, a phytochemical from broccoli and it is prepared as a simple extract of broccoli seeds. Glucoraphanin is converted to sulforaphane by bacteria in the human intestines. Crucera-SGS is formulated by Thorne Research Inc. into gel-caps that make it much more convenient to deliver than having subjects eat broccoli every day.
15946694|NCT03289832|Dietary Supplement|Meriva 500-SF|Meriva-SF is a commercially available dietary supplement. The active ingredient is curcumin, a phytochemical from the spice, turmeric, and it is prepared as a simple extract of this plant, formulated with lipids which aid in its absorption and metabolism. Meriva-SF is formulated by Thorne Research Inc. into gel-caps that make it much more convenient to deliver than having subjects eat turmeric powder every day.
15947028|NCT03287206|Biological|blood samples from children|CGH array, Fragile-X syndrome screening, DI459 panel, WES
15946695|NCT03289819|Drug|Pembrolizumab|All patients will receive 12 cycles of weekly nab-paclitaxel intravenous (i.v.) 125 mg/m² body surface area (BSA) in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w; followed by 4 cycles of epirubicin i.v. 90 mg/m² BSA and cyclophosphamide i.v. 600 mg/m² BSA, q3w in combination with 4 cycles of pembrolizumab i.v. 200 mg/kg q3w. After the 25th patient has started trial treatment, all further included patients will receive 1 cycle of pembrolizumab i.v. 200 mg q3w monotherapy followed by 12 cycles of weekly nab-paclitaxel intravenous (i.v.) 125 mg/m² body surface area (BSA) in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w; followed by 4 cycles of epirubicin i.v. 90 mg/m² BSA and cyclophosphamide i.v. 600 mg/m² BSA, q3w in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w.
15946696|NCT03289819|Drug|nab-paclitaxel|All patients will receive 12 cycles of weekly nab-paclitaxel intravenous (i.v.) 125 mg/m² body surface area (BSA) in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w; followed by 4 cycles of epirubicin i.v. 90 mg/m² BSA and cyclophosphamide i.v. 600 mg/m² BSA, q3w in combination with 4 cycles of pembrolizumab i.v. 200 mg/kg q3w.
15946697|NCT03289819|Drug|Epirubicin|All patients will receive 12 cycles of weekly nab-paclitaxel intravenous (i.v.) 125 mg/m² body surface area (BSA) in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w; followed by 4 cycles of epirubicin i.v. 90 mg/m² BSA and cyclophosphamide i.v. 600 mg/m² BSA, q3w in combination with 4 cycles of pembrolizumab i.v. 200 mg/kg q3w.
15946698|NCT03289819|Drug|Cyclophosphamide|All patients will receive 12 cycles of weekly nab-paclitaxel intravenous (i.v.) 125 mg/m² body surface area (BSA) in combination with 4 cycles of pembrolizumab i.v. 200 mg q3w; followed by 4 cycles of epirubicin i.v. 90 mg/m² BSA and cyclophosphamide i.v. 600 mg/m² BSA, q3w in combination with 4 cycles of pembrolizumab i.v. 200 mg/kg q3w.
15946699|NCT03289806|Procedure|Samples of fibroblasts from Tenon's capsule|
15946700|NCT03289793|Other|Neurofeedback training|"Children in group A will receive BCI-based training implemented through original P300-based controlled games.
~They will attend 30 1-hour long training sessions at a pace of 2 sessions per week.
~Each session includes: installation of the child, the EEG system and an eye-tracking system, a 5-minutes relaxation phase, a short EEG recording at rest, a brief reminder of the instructions, 30 minutes of training by playing video games and finally a time for the child to wash her/his hair.
~Moreover, 4 neuropsychological sessions will complement the 30 training sessions. During these sessions neuropsychological tests and quality of life questionnaires will be answered."
15946701|NCT03289793|Other|Active Sham control|"Children in group B will receive a training that is not based on brain activity, but in a blind fashion. They will attend 30 1-hour long training sessions at a pace of 2 sessions per week.
~Each session includes: installation of the child, setting up the EEG and eye-tracking systems, a 5-minutes relaxation phase, short EEG recording at rest, a brief reminder of the instructions, 30 minutes of video game based training and finally a time for the child to wash her/his hair.
~Besides, 4 neuropsychological sessions will complement the 30 training sessions. During these sessions neuropsychological tests and quality of life questionnaires will be performed."
15946702|NCT03289793|Other|Baseline control group|The children included in this group will not receive any training. They only take part to the 4 neuropsychological sessions. Like others, they will attend 1 neuropsychological session every two months over six months.
15946703|NCT03289767|Other|Curved-tube|"Connecting both ends of the endotracheal tube (O shape) for 5-min and releasing it provides additional anterior angle temporarily."
15946704|NCT03289754|Device|iPoly XE tibial insert with ConforMIS iTotal KRS|The implants are constructed to conform to the surface of the patient's femoral condyle and proximal tibia, replacing the damaged cartilage with a smooth articulating surface. The femoral component and tibial tray are manufactured from cobalt chromium molybdenum alloy. The tibial insert and patellar component are manufactured from ultra-high molecular weight polyethylene.
15946705|NCT03289741|Drug|Octreotide|Patients will receive three monthly injections every 28 (+/- 3) days. Octreotide LAR for 3 injections followed by lanreotide for 3 injections
15946706|NCT03289741|Drug|LAR Lanreotide|Patients will receive three monthly injections every 28 (+/- 3) days. Lanreotide for 3 injections followed by octreotide LAR for 3 injections
15946707|NCT03289741|Behavioral|Questionnaires|Baseline questionnaire, Post-treatment questionnaire (after the first 3 injections), Preference questionnaire and Pain Score Diary.
15946708|NCT03289728|Other|Stress single photon emission CT (SPECT) or Stress ultrasound with dobutamine (DSE)|"Stress single photon emission CT (SPECT) or Stress ultrasound with dobutamine (DSE), performed using standard protocol.
~Patients with ≥ moderate ischemia observed by SPECT (≥ 10% of the myocardium or transient ischaemic dilatation or reduced post-stress ejection fraction (EF)) or abnormal movements of the myocardial walls observed during a stress echocardiogram (≥ 3/17 segments) will benefit from coronary angiography. Depending on the results of coronary angiography and on the coronary anatomy and other clinical and para-clinical considerations (territory of myocardial ischemia) revascularisation will be performed (REVASC). Patients with < moderate ischemia will receive medical treatment only (MT)."
15946709|NCT03289728|Procedure|Cornorary angioplasty|Participants randomized to the SCA group, will benefit from a coronary angiography within 24 to 72 hours after the diagnosis of NSTEMI; without any preliminary ischemia imaging.
15946710|NCT03289715|Device|On Demand Humidification system Mark 2|The on demand humidification humidifier is set up to alternate between periods of humidification and no humidification totaling 6 periods of 30 minutes duration each. Thus, the test will consist of 3 cycles of disabled humidification and enabled humidification. Each cycle will be with a different humidification setting to assess which setting is most comfortable. In the second phase, the patient will be treated with the dose they had the best experience with in the first test.
15946711|NCT03289702|Drug|CORETOX®|upper limb will be injected and evaluated in the study. Maximun injection dose is 360U.
15946712|NCT03289702|Drug|BOTOX®|upper limb will be injected and evaluated in the study. Maximun injection dose is 360U.
15946713|NCT03289689|Device|Whole-body vibration (WBV)|Whole-body vibration (WBV) is a novel neuromuscular therapeutic intervention that has recently been developed since in the mid-1960s. Hagbart and Eklund showed in human experiments that a reflex muscle contraction can result as a consequence of applying vibrations to the muscular-tendon system. The subjects stand on a platform that generates stochastic vibrations at a frequency between 1-12.5 Hz.
15946746|NCT03289416|Combination Product|Pure PRP II|The Pure PRP II system will be used to collect and concentrate blood into platelet rich plasma that will be injected into the knee.
15982326|NCT03019237|Other|intranasal allergen|intranasal allergen
15946714|NCT03289676|Combination Product|Storytelling Narrative Intervention|"In the first phase, three sections of a video, each for 5-7 minutes will be produced by Star story tellers who are eloquent and have authentic personal experiences of quitting smoking. Participants who receive 8-weekly 30-minute cessation counseling sessions along with NRT are randomly assigned to watch either the smoking cessation video or attention-control video of women taking about their HIV infection."
15946715|NCT03289663|Drug|synergistic combination of insecticides|third generation insecticide -treated bednets
15946716|NCT03289663|Drug|Pyrethroids|Conventional insecticide
15946717|NCT03289650|Drug|Tacrolimus|immunosuppressive agent tacrolimus, given twice-daily
15946718|NCT03289650|Drug|Tacrolimus Extended Release Oral Tablet [Envarsus]|immunosuppressive agent extended-release tacrolimus, given once daily
15946719|NCT03289637|Dietary Supplement|Vitamin D|Vitamin D intervention tested against placebo in a population with heart failure and a 25-OH-vitamin D level<50nmol/L at screening
15946720|NCT03289624|Behavioral|SHARE-CC|"Each of the 6 SHARE-CC sessions are structured similarly, starting with the dyad reviewing goals of the session, the CG & PWCC meeting jointly or separately with the SHARE-CC Counselor around session-specific material, & ending with a review of material, addressing questions, & previewing the next session. Sessions titles are: Communication & Health Education; Care Values; Care Preferences; Family, Friends, & Community Resources; Taking care of yourself-taking care of each other; & Take Action Now.
~The SHARE plan will be developed throughout the sessions and reflects the consensus achieved because of participating in SHARE-CC. It is intended to ensure that the PWCC's values & preferences are supported when decisions have to be in the future."
15946721|NCT03289611|Biological|sFlt-1 / PlGF ratio|"Ambulatory management if sFlt-1 / PlGF ratio is below 38
~usual management if sFlt-1/PlGF is between 38 and 85.
~If the ratio is > 85, monitoring will be intensified and patient hospitalization will be continued"
15946722|NCT03289598|Behavioral|A rehabilitation process involving collaborative goal setting with a case manager about managing own food and meals|"The intervention consists of two parts:
~Education of the health care staff with three day's education focusing of aspects of food, meals and nutrition to old people.
~The individual participants in the intervention group will be participating in a rehabilitation process involving collaborative goal setting with a case manager. All the case managers have a background as registered dietician and will before start of the intervention be trained in managing a rehabilitation process with focus on meals and food. The training will consist of three days of education in, respectively, areas in relation to rehabilitation and the role as a care manager. Specific topics include; assessment of functional abilities in relation to meals and food; goal setting by means of GAS (Goal Attainment Scaling), ethical considerations and communication."
15946723|NCT03289559|Drug|GnRH antagonist|
15946724|NCT03289559|Drug|Aromatase Inhibitors|
15946725|NCT03289559|Drug|Testosterone gel|
15946726|NCT03289546|Behavioral|Mindfulness training|"The mindfulness training protocol will include the following basic components of traditional mindfulness-based stress reduction training: 1) training in awareness of sensations (body scan); 2) training in the awareness of the sensations of breathing; 3) training in directing the attention to simple activities of daily life, and in recognizing when the attention is no longer focused on a specific object of attention; and 4) training in 'open awareness'."
15946727|NCT03289546|Behavioral|Aerobic training|Exercise sessions will be led by CPR- and exercise-certified YMCA instructors and supervised by the senior research assistant. Sessions will consist of 10 minutes of warm-up, 40 minutes of aerobic exercise (walking on a treadmill), 10 minutes of cool down and stretching. Participants will receive heart monitors at the beginning of the study and will be trained by the senior research assistant to exercise targeting heart rates at 65-75% of the age predicted max heart rate or at an intensity of 12-13 in the Borg scale of the rate of perceived exertion.
15946728|NCT03289533|Drug|Avelumab (MSB0010718C)|Patients will receive avelumab 10 mg/kg Q2W in combination with axitinib 5 mg BID.
15946729|NCT03289533|Drug|Axitinib (AG-013736)|Patients will receive avelumab 10 mg/kg Q2W in combination with axitinib 5 mg BID.
15946730|NCT03289520|Drug|Clopidogrel|
15946731|NCT03289520|Drug|Placebo|
15946732|NCT03289507|Dietary Supplement|Treatment1|Longvida Capsule formulation A
15946733|NCT03289507|Dietary Supplement|Treatment2|Longvida Capsule formulation B
15946734|NCT03289507|Dietary Supplement|Treatment3|Curcuma longa extract of Rhizomes
15946735|NCT03289494|Other|Balanced diet high in Slowly Digestible Starch|The carbohydrate present in the diet high in Slowly Digestible Starch were selected according to the general recommendations made for diabetics and according to their SDS content. The diet will be consumed during one week.
15946736|NCT03289494|Other|Balanced diet low in Slowly Digestible Starch|The carbohydrate present in the diet low in Slowly Digestible Starch were selected according to the general recommendations made for diabetics and according to their SDS content. The diet will be consumed during one week.
15946737|NCT03289481|Dietary Supplement|Active lozenge|nitric oxide generating lozenge
15946738|NCT03289481|Drug|Placebo|placebo tablet
15946739|NCT03289468|Diagnostic Test|Voluson E8 (GE Medical Systems, USA), Minimally Invasive Endometrium Sampler|The endometrial thickness, basic characteristics information and endometrial blood flow energy index, endometrial vascularization index, blood flow index are detected by color power Doppler and the energy histogram of endometrium is obtained using a Voluson E8 (GE Medical Systems, USA) ultrasound system. The specimen of uterine cytology and endometrial tissue are obtained through minimally invasive endometrium sampler, which are diagnosed by pathology.
15946740|NCT03289455|Biological|AUTO3 (CD19/22 CAR T cells|Following preconditioning with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with 1 to 5.0 x 10⁶/kg CD19/CD22 Chimeric Antigen Receptor (CAR) positive T cells as a single or split dose.
15946741|NCT03289442|Procedure|supine position|patients were positioned on their supine position to receive colonoscopy insertion
15946742|NCT03289429|Drug|Atorvastatin|Atorvastatin in a dose of 80 mgs, twelve hours preoperatively, two hours preoperatively, and on the 2nd, 3rd, 4th and 5th postoperative days.
15946743|NCT03289429|Drug|Magnesium Sulfate|Magnesium sulfate: ( 3 grams dissolved in 100 mL of isotonic saline to be infused over 2 hours) twelve hours preoperatively, within the first hour of ICU arrival, and on the 2nd and 3rd postoperative days.
15946869|NCT03288441|Drug|Hold|Hold antithrombotic therapy
15947029|NCT03287206|Biological|blood samples from parents|secondary controls for children's analyses
15946747|NCT03289416|Combination Product|PureBMC|The PureBMC system will be used to collect and concentrate bone marrow aspirate into bone marrow concentrate that will be injected into the knee.
15946748|NCT03289403|Drug|Immunomodulatory|"Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D before ICSI cycle.
~Moreover, patients will receive a treatment course of immunomodulatory drugs for 3 -6 months before ICSI cycle:
~Prednisnlone 40mg for 2 weeks to be lowered gradually till become 5mg after 6 weeks and to be continued
~Hydroxychloroquine according to body weight, patients who develop hypersensitivity will be shifted to Azathioprin.
~Immunoglobulins will be used in cases not responding to treatment."
15946749|NCT03289403|Drug|Thyroxine|"Patients will receive thyroxine , low dose aspirin , low dose selenium, Calcium and vitamin D before ICSI cycle.
~Patients will not receive immunomodulatory drugs"
15946750|NCT03289390|Drug|Acetaminophen|Acetaminophen given at discretion of medical team for PDA treatment. Research team to evaluate pre and post laboratory values and echocardiograms.
15946751|NCT03289377|Behavioral|RDAD Training|An interactive processes of lecture, role-play, and discussion, APNs will have the opportunity to dissect all phases of RDAD to insure they understand the objectives, can enact the program, and feel confident they can problem-solve situations that arise. APNs will receive materials to insure they are knowledgeable about ADRD symptoms, behavior management techniques, and exercise safety.
15946752|NCT03289364|Device|Penguin Cold Caps|Patients will wear Penguin Cold Cap scalp cooling device prior to each chemotherapy administration, during administration, and for four hours following administration.
15946753|NCT03289351|Drug|piperacillin-tazobactam|Single drug therapy
15946754|NCT03289338|Drug|Zoledronic Acid|Zoledronic acid 5mg intravenous once a month for 3 months
15946755|NCT03289338|Drug|Methylprednisolone|Methylprednisolone 1gm intravenous once a month for 3 months
15946756|NCT03289338|Drug|Placebos|Normal saline intravenous once a month for 3 months
15946757|NCT03289325|Drug|dexmedetomidine hydrochloride for injection|"Before anesthesia, dexmedetomidine hydrochloride for injection (200 ug/2 ml) will be diluted with normal saline to 50 ml (final dexmedetomidine concentration 4 ug/ml).
~Before anesthesia induction, a loading dose will be administered by intravenous infusion at a rate of [0.9*kg] ml/h for 10 minutes (i.e., dexmedetomidine 0.6 ug/kg in 10 minutes), followed by continuous infusion at a rate of [0.1*kg] ml/h (i.e., dexmedetomidine at a rate of 0.4 ug/kg/h) until the end of surgery.
~After surgery, the infusion rate will be decreased to [0.025*kg] ml/h (i.e., dexmedetomidine at a rate of 0.1 ug/kg/h) and continued until the end of mechanical ventilation."
15946758|NCT03289325|Drug|0.9% sodium chloride for injection|"Before anesthesia, 0.9% sodium chloride for injection 50 ml will be prepared.
~Before anesthesia induction, a loading dose will be administered by intravenous infusion at a rate of [0.9*kg] ml/h for 10 minutes, followed by continuous infusion at a rate of [0.1*kg] ml/h until the end of surgery.
~After surgery, the infusion rate will be decreased to [0.025*kg] ml/h and continued until the end of mechanical ventilation."
15946759|NCT03289299|Drug|Carfilzomib|56 mg/m2 IV given on days 1, 8, and 15 of each cycle during induction and consolidation phases of the study.
15946760|NCT03289299|Drug|Lenalidomide|"25 mg po given on days 1-21 of each cycle during the induction and consolidation phases.
~10 mg po given on days 1-21 of each cycle during the maintenance phase."
15946761|NCT03289299|Drug|Daratumumab|16 mg/kg IV given on days 1, 8, 15, and 22 of cycles 1-2; days 1 and 15 of cycles 3-6; day 1 of cycle 7-12; Day 1 of odd cycles for cycles 13-24.
15946762|NCT03289299|Drug|Dexamethasone|40 mg oral given on days 1, 8, 15, and 22 of cycles 1-6 20 mg oral given on days 1, 8, 15, and 22 of cycles 7-12
15946763|NCT03289286|Other|Dedicated and coordinated e-follow-up.|"In pre- and post-surgery:
~Completion of questionnaires using an electronic tool,
~Telephone follow-up if necessary between the nurse and the patient."
15946765|NCT03289260|Drug|Imiquimod 5% cream|Patients receive topical Imiquimod therapy for 12 weeks.
15946766|NCT03289260|Drug|Placebo cream|Patients receive topical Doritin therapy for 12 weeks
15946767|NCT03289260|Procedure|Fulguration|Surgical Excision and Fulguration of condyloma
15946768|NCT03289247|Device|tissue adhesive (Leukosan®)|Tissue ahaesive
15946769|NCT03289234|Drug|MCI-186|30 mg of edaravone will be administered intravenously over 60 minutes
15946770|NCT03289221|Diagnostic Test|Anal Manometry|"A suppository will be used to clean the rectum 3 to 4 hours prior to the examination. And the pressures of rest and voluntary contraction of the anal sphincter will be evaluated, as well as the behavior of the pubortal muscle during the evacuation maneuver. Retinal inhibitory reflex (RIRA), sensitivity and rectal capacity will also be evaluated.
~Questionnaires that evaluate the pre and post HIFU anal physiology will also be applied at the time of manometry."
15946771|NCT03289208|Drug|MCI-186|30 mg of edaravone will be administered intravenously over 60 minutes.
15946772|NCT03289195|Procedure|MRI Biopsy|Patient will undergo percutaneous MR guided biopsy by study Breast Radiologist within 0-60 days of completing NAC.
15946773|NCT03289182|Drug|MabThera|Participants will be administered MabThera 1400 mg (NHL) or 1600 mg (CLL) at the discretion of the physician in accordance with local clinical practice and local labeling.
15946774|NCT03289169|Drug|MEDITOXIN®|20U of Meditoxin® is injected to two places on the corrugators muscle for each eye and one place on the procerus muscle, total of 5 sites.
15946775|NCT03289156|Behavioral|Arousal Reappraisal|Brief readings educating about the stress response and usefulness of arousal reappraisal.
15946776|NCT03289156|Behavioral|Exercise|Three 5-minute bouts of exercise at increasing intensities (65%, 75%, and 85%) with 5-15 minute breaks in-between for recovery.
15946777|NCT03289143|Drug|Semorinemab|Participants will receive Semorinemab intravenously (IV).
15946778|NCT03289143|Drug|Placebo|Matching placebo doses of Semorinemab given intravenously (IV).
15946779|NCT03289143|Drug|[18F]GTP1|[18F]GTP1 will be administered as a solution for intravenous (IV) use, as part of positron emission tomography (PET) imaging.
15946780|NCT03289117|Device|Novel gel installation device procedure|Catheter change with novel device Each subject will undergo catheter change with novel gel instillation device
15946781|NCT03289117|Device|Standard procedure|Catheter change with standard procedure Each subject will undergo catheter change with standard procedure
15947030|NCT03287193|Biological|Blood sample|for patient and its parents
15946782|NCT03289104|Device|Steel Wires|Control: Steel wires (device) are selected for sternal closure after surgery. Currently, most patients who have a sternotomy during cardiac surgery have their sternum closed with steel wires.
15946783|NCT03289104|Device|ZipFix Sternal Closure System|Treatment: ZipFix system (device) are selected for sternal closure after surgery. These plastic cables can also be used to close the sternum during bypass surgery.
15946784|NCT03289091|Behavioral|water-based continuous aerobic training|Participants who will be randomized for the continuous aerobic training group will carry out exercises with no interval for exercise change. Intensity will be increased every mesocycle. In the first mesocycle (weeks 1-4), participants will carry out three 4-minute series of each exercise whose intensity corresponds to the Rating of Perceived Exertion (RPE) 13. In the second mesocycle (weeks 5-8), participants will perform four 3-minute series of each exercise corresponding to RPE 14. In the third mesocycle, participants will perform six 2-minute series of each exercise at intensity corresponding to RPE 15 from weeks 9-10, whereas intensity corresponding to RPE 16 will be experienced from weeks 11-12.
15946785|NCT03289091|Behavioral|water-based interval aerobic training|Participants who will be randomized for interval aerobic training group will carry out exercises which associate effort phases, at higher intensity and recovery phases, at lower intensity, with no interval for exercise change. Intensity will be increased every mesocycle. The first mesocycle (weeks 1-4) comprises three 4-minute series of each exercise whose intensity corresponds to the RPE 16 for 2 minutes and RPE 11 for 2 minutes. The second mesocycle (weeks 5-8) includes four 3-minute series of each exercise whose intensity corresponds to the RPE 17 for 1.5 minutes and RPE 11 for 2 minutes. The third mesocycle (weeks 9-12) comprises six 2-minute series of each exercise whose intensity corresponds to the RPE 18 for 1 minute and RPE 11 for 1 minute.
15946786|NCT03289078|Other|Spa Treatment|The spa treatments will be realised daily 6 days a week and during 18 days. The care will be provided is : Swimming pool of mobilization by physical therapist (20 minutes daily, Cataplasms (10 minutes daily), Shower in the jet (10 minutes daily), Shower under affusion (10 minutes daily)
15946787|NCT03289052|Device|Restylane Volyme|Subcutis injection
15946790|NCT03289026|Drug|Aripiprazole|Doses were flexibly titrated to between 10 and 30 mg once daily based on the individual needs of the patient as determined by the investigator.
15946791|NCT03289013|Other|Standard adhesive 1|This strip consists of a standard hydrocolloid adhesive found in ostomy devices
15946792|NCT03289013|Other|Standard adhesive 2|This strip consists of a standard hydrocolloid adhesive found in ostomy devices
15946793|NCT03289013|Other|LT-2|Newly developed adhesive
15946794|NCT03289013|Other|LT-21|Newly developed adhesive
15946795|NCT03289013|Other|LT-25|Newly developed adhesive
15946796|NCT03289013|Other|33-20|Newly developed adhesive
15946797|NCT03289000|Device|iTotal Posterior Stabilized (PS) Knee Replacement System|Patient-specific posterior stabilized total knee replacement and patient specific surgical jigs
15946798|NCT03288987|Drug|Bevacizumab + FOLFIRI-3|Bevacizumab 5 mg/kg will be administered at day 1 every 2 weeks. Initially, it will be administered as a 90-min infusion. If the first infusion is well tolerated, the second will be delivered as a 60-min infusion, and if the 60-min infusion is well tolerated, all subsequent infusions will be given over 30 minutes. FOLFIRI-3 regimen consists of irinotecan 100 mg/m2 over 1 hour at day 1, leucovorin 400 mg/m2 at day 1 followed by a 46 hour 5-FU continuous infusion (2000 mg/m2) and irinotecan 100 mg/m2 over 1 hour on day 3 will administer. Induction treatment was administrated every 2 weeks until disease progression, unacceptable toxicities, surgical intervention, or withdrawal of consent.
15946799|NCT03288974|Drug|POMALYST® (Pomalidomide)|The recommended starting dose of POMALYST is 4 mg once daily taken orally on Days 1 to 21 of repeated 28-day cycles. The recommended dose of dexamethasone is 40 mg orally once daily on Days 1, 8, 15 and 22 of each 28-day treatment cycle
15946800|NCT03288948|Other|Binocular games for treatment of amblyopia|playing binocular games on a tablet platform 1 hour per day 5 days per week with reduced contrast for the fellow eye and high contrast for the amblyopic eye
15946801|NCT03288935|Behavioral|TICM|The TICM will be designed to include the seven domains of trauma-informed care articulated by SAMHSA (2014): 1) early screening and comprehensive assessment; 2) consumer driven care and services; 3) trauma-informed, responsive and educated workforce; 4) emerging and evidence-informed best practices; 5) safe and secure environments; 6) trauma-informed community partnerships; and 7) a performance monitoring system. The trained agency case managers and staff will provide the TICM to 50 newly resettled refugees during their regular R&P service period (i.e., 60 days).
15946802|NCT03288935|Behavioral|TICO|The community-based TICO will be based on the Im's CHW that comprises 8 sessions (2 hour per session), co-facilitated by trained refugee peer mentors and community service providers. The TICO sessions will include interactive sessions on healthy eating, healthy body and healthy mind, acculturation & resettlement stress, understanding trauma and stress, healthy coping, helping others, and community building.
15946803|NCT03288922|Procedure|Limited BF OL-HDF with SHF|"The new modality Limited BF OL-HDF with SHF were performed using Fresenius 5008 hemodiafiltration machine. The prescribed blood flow rate was 300 ml/min and the total dialysis fluid flow rate was 800 ml/min which included pre-filter substitution rate of 150 ml/min. The super high-flux dialyzer was PES-17Dα from Nipro Corporation, Japan which contains 1.7 m2 hollow fiber polyethersulfone membrane (ultrafiltration coefficient 80 ml/h/mmHg; urea clearance 267 ml/min, Qb 300 ml/min and Qd 500ml/min). The patients were received this treatment thrice-a-week for 2 week before entering the wash-out period and crossover to another arm."
15946804|NCT03288922|Procedure|High-efficiency OL-HDF|"The controlled modality High-efficiency OL-HDF were performed using Fresenius 5008 hemodiafiltration machine. The prescribed blood flow rate was 400 ml/min and the total dialysis fluid flow rate was 800 ml/min which included post-filter substitution rate of 100 ml/min. The standard high-flux dialyzer that was used was HF80s from Fresenius Medical Care, Germany contains 1.8 m2 hollow fiber polysulfone membrane (ultrafiltration coefficient 55 ml/h/mmHg; urea clearance 248 ml/min, Qb 300ml/min and Qd 500 ml/min). The patients were received this treatment thrice-a-week for 2 week before entering the wash-out period and crossover to another arm."
15946805|NCT03288909|Other|MRI|
15946806|NCT03288896|Behavioral|Alerta Alcohol|The intervention consists of preventive messages about the benefits of not consuming alcohol, reducing the positive attitudes and encouraging the negative attitudes towards alcohol drinking and binge drinking, as well as social influence and self-efficacy, by personalized feedback. Skills and action plans are encouraged to help the student to reject binge drinking. This information is presented through different tailored messages. Moreover, four avatars (two males and two females), which can be chosen as part of the story development. This story consists of a short story about the alcohol consumption by adolescents.The stories take place in three different scenarios (at home, at celebrations and in public places).
15946807|NCT03288883|Device|Photothermal Non-ablative Erbium:YAG-laser|Laser treatment of the vagina for GSM
15946808|NCT03288883|Device|Fractional Microablative CO2-laser|Laser treatment of the vagina for GSM
15946809|NCT03288870|Drug|BCD-100|monoclonal antibody to PD-1 receptor
15946810|NCT03288870|Drug|Docetaxel|Chemotherapy drug (taxane)
15946811|NCT03288857|Device|NeilMed Naspira|NeilMed Naspira is a nasal-oral aspirator
15946812|NCT03288844|Procedure|Ophthalmologic examinations|epithelial defects assessment by fluorescein staining; superficial corneal neo-vascularization assessment; ocular tonometry; slit lamp examination; conjunctival (both bulbar and limbal) inflammation assessment; corneal sensitivity; central cornea involvement (for opacity or central CNV); Best-Corrected Visual Acuity; evaluation of symptoms.
15946813|NCT03288844|Other|Digital pictures|Digital pictures 2D to be taken at each visit
15946814|NCT03288844|Other|QoL Questionnaires|Quality of Life (NEI VFQ 25 and EQ-5D-3L/Y) questionnaires will be submitted at each visit
15946815|NCT03288831|Dietary Supplement|Gluten|Six grams of gluten will be mixed with water and Tang flavoring. Subjects will drink the mixture one time.
15946816|NCT03288831|Dietary Supplement|Placebo|Subjects will drink a mixture of rice water and Tang flavoring one time.
15946817|NCT03288818|Drug|Mechlorethamine Hydrochloride Gel|Given topically
15946818|NCT03288818|Procedure|Total Skin Electron Beam Radiation Therapy|Undergo low dose (TSEBT) Total Skin Electron Beam Therapy
15946819|NCT03288792|Device|RI8 device imaging|RI8 Device imaging for adjunctive detection of breast cancer
15946820|NCT03288779|Device|Theta Burst Stimulation|Transcranial magnetic stimulation with theta burst stimulation
15946822|NCT03288753|Other|Satisfaction questionnaire|Participants have to complete a satisfaction questionnaire on the Neuro 1 or 2 processor.
15946823|NCT03288753|Behavioral|Speech intelligibility in quiet|The speech material corresponds to the lists of Lafon designed for cochlear implant patients. Each lists contains 17 monosyllabic words. Speech comprehension is evaluated by the percentage of correct words and the percentage of correct phonemes. Speech signals are presented at 65 dB SPL. 2 lists of 17 words are presented. At visit 1, the participants wear the sound processor Neuro 1. At visits 2 and 3, the participants wear the Neuro 2.
15946824|NCT03288753|Behavioral|Speech intelligibility in noise|The speech material corresponds to the lists of Lafon designed for cochlear implant patients. Each lists contains 17 monosyllabic words. Speech comprehension is evaluated by the percentage of correct words and the percentage of correct phonemes. Speech signals are presented at 65 dB SPL. 2 lists of 17 words are presented. The noise corresponds to a cocktail party presented at +10 dB SNR (Speech on Noise Ratio). At visit 1, the participants wear the sound processor Neuro 1. At visits 2 and 3, the participants wear the Neuro 2.
15946825|NCT03288753|Behavioral|VRB (Vocale Rapide dans le Bruit)|Speech intelligibility in noise measured with the test VRB (Vocale Rapide dans le Bruit, French version of the Quick Sin). This test measures the SNR (Signal to Noise Ratio) at which the listeners understand half of the words of a sentence correctly. The outcome measure is in dB. 3 lists are presented. Speech signals are presented at 60 dB SPL.
15946826|NCT03288740|Drug|Semaglutide 0.5 mg|A dose of 0.25 mg semaglutide gradually increased to 0.5 mg injected subcutaneously (under the skin) once weekly for 13 weeks.
15946827|NCT03288740|Drug|Placebo (semaglutide 0.5 mg)|A dose of 0.25 mg semaglutide placebo gradually increased to 0.5 mg injected subcutaneously (under the skin) once weekly for 13 weeks.
15946828|NCT03288740|Drug|Semaglutide 1.0 mg|A dose of 0.25 mg semaglutide gradually increased to 1.0 mg injected subcutaneously (under the skin) once weekly for 13 weeks.
15946829|NCT03288740|Drug|Placebo (semaglutide 1.0 mg)|A dose of 0.25 mg semaglutide placebo gradually increased to 1.0 mg injected subcutaneously (under the skin) once weekly for 13 weeks.
15946830|NCT03288727|Other|interviews with a psychologist|an interview with a psychologist / sociologist will take place after completion of the on-site questionnaires to find out the reasons for their choice of accessing their secondary data and their experiences with the secondary data reported.
15946831|NCT03288714|Device|Synchronized Transcranial Magnetic Stimulation (sTMS)|sTMS delivers brain stimulation via a continuous magnetic field created by the device and set to the individual patient's intrinsic alpha frequency (IAF).
15946832|NCT03288714|Device|Sham Stimulation|Sham stimulation is designed to look, sound and feel like the investigational device, but does not deliver magnetic stimulation to the brain.
15946833|NCT03288701|Device|Seca medical Body Composition Analyser 515|Comparison of reduction of whole body water and body weight in patients with decompensated heart failure under forced diuretic treatment
15946870|NCT03288441|Drug|Prophylactic dose antithrombotic|Reduction in antithrombotic medication dose to prophylactic dose (without changing type)
15946871|NCT03288441|Drug|Change antithrombotic Drug|Change in type of antithrombotic therapy
15946872|NCT03288441|Biological|Change platelet transfusion threshold|Increase or reduce platelet transfusion threshold
15946873|NCT03288441|Drug|Full dose antithrombotics|Continue full dose antithrombotic therapy
15946834|NCT03288688|Other|Exercise program and education|"The exercise program comprises warm-ups, exercises and cool-downs and aims to improve recruitment, strength and endurance of postural muscle groups that are key to the work of a musician. Basic activation exercises progress to dynamic and resisted exercises as well as functional musical movements. There is a series of six exercises of increasing difficulty for each of the following bodily regions: hips, back, neck, shoulders and abdominals.
~Topics to be discussed in the educational presentation and e-mails include healthy practice habits, activity dosage, the importance of physical activity, how the body adapts to workload and physical stressors, and instructions pertaining to the exercise program."
15946835|NCT03288675|Device|aiTBS|In the active aiTBS arm, the patients will receive 100 cycli of thetaburst trains of 2s, separated by an inter-train-interval of 6 seconds, delivered on the left dorsolateral prefrontal cortex (DLPFC; i.e. 3000 pulses per session). On each stimulation day, a given patient will receive 5 sessions with a between-session interval of 15 minutes. The treatment protocol of in total 20 aiTBS sessions will be spread over 4 days (i.e. 60.000 pulses in total). The sham coil has been specifically developed to mimic the real one.
15946836|NCT03288675|Behavioral|CCT|By training working memory processing, the CCT aims at modulating similar prefrontal cortex regions as being stimulated previously by aiTBS, namely the DLPFC. thereby possibly stabilizing clinical effects of aiTBS over time. In total 20 sessions of CCT vs. control training (of approximately 25 minutes per session), will be spread over a period of 4 weeks.
15946837|NCT03288675|Drug|SSRI|All patients will be prescribed antidepressant medication (SSRI) again when starting the CCT (vs. control training).
15946838|NCT03288662|Other|CT and histopathological classification|Cross-sectional descriptive study on 53 patients with diagnosed of thymoma by CT and had postoperative histopathology results as thymic epithelial tumors. Base on the characteristics in Chest CT scan in each postoperative histopathology results.
15946839|NCT03288636|Drug|Danoprevir|Danoprevir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23
15946840|NCT03288636|Drug|Ritonavir|Ritonavir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23
15946841|NCT03288636|Drug|Ravidasvir|Ravidasvir tablet administered orally 200mg QD on day 1, 13 - 23
15946842|NCT03288636|Drug|Placebo|Placebo
15946843|NCT03288623|Dietary Supplement|Dark Chocolate (85% cocoa)|Dark chocolate (85% cocoa) in tablet
15946844|NCT03288623|Dietary Supplement|White/Milk chocolate (<35% cocoa)|white or milk chocolate (<35% cocoa) in tablet
15946845|NCT03288610|Diagnostic Test|Preoperative copeptin level|Measure of plasmatic copeptin from preoperative samples retained in a biorepository. Physicians are blinded to the result.
15946846|NCT03288597|Radiation|68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NET|At the beginning of the treatment with SSA, after 6 months, 12 months, or chemotherapy, after 3 months or progression receive 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT
15946847|NCT03288597|Radiation|68Ga-DOTANOC PET/CT and 18F-FDG PET/CT in NEC|At the beginning of the treatment with chemotherapy 4-6 cycles or progression receive 68Ga-DOTANOC PET/CT and 18F-FDG PET/CT
15946848|NCT03288584|Drug|Tocilizumab (Actemra®)|Inhibition of Interleukin-6 activity by tocilizumab (Actemra®) 150mg od, sc injection
15946849|NCT03288584|Drug|Other biological agent|Other biological agent (TNFa inhibitor, abatacept, rituximab, IL-1Ra)
15946850|NCT03288584|Drug|Corticosteroid and non-biological agents.|Enhanced treatment with corticosteroid and non-biological agents.
15946851|NCT03288571|Biological|Wharton Jelly Mesenchymal stem cells|Wharton Jelly Mesenchymal stem cells will be injected in the renal parenchyma
15946852|NCT03288558|Other|A comprehensive perioperative mechanical ventilation strategy|"1) Intervention group.
~Recruitment maneuvers (doubling the tidal volumes for 10 consecutive breaths) every 30min and after every time mechanical ventilation is stopped for surgical reasons, suctioning occurs or the breathing circuit is disconnected
~Mechanical ventilation will be continued during CPB (PEEP 5 cm H2O, respiratory rate 8/min, Tidal Volume 6 ml/kg PBW, FiO2 21%
~Avoidance of lung de-recruitment during patient's transfer (use of PEEP via PEEP valves, endotracheal tube clamps during disconnection from the breathing circuit)
~Avoidance of disconnection from respiratory circuit during respiratory secretions suctioning (applying closed suction circuits)
~For the remaining aspects the mechanical ventilation settings will be the same as in the control group.
~Tidal volume 6ml/kg PBW PEEP 5cm H20 FiO2 to target SatO2 of 92-97% Discontinuation of mechanical ventilation during cardiopulmonary bypass"
15946853|NCT03288545|Drug|enfortumab vedotin (EV)|Intravenous (IV) infusion on days 1 and 8 every 21 days
15946854|NCT03288545|Drug|pembrolizumab|IV infusion on day 1 every 21 days
15946855|NCT03288545|Drug|cisplatin|IV infusion on day 1 every 21 days
15946856|NCT03288545|Drug|carboplatin|IV infusion on day 1 every 21 days
15946857|NCT03288545|Drug|gemcitabine|IV infusion on days 1 and 8 every 21 days
15946858|NCT03288532|Drug|Durvalumab|controlled infusion via an infusion pump into a peripheral or central vein
15946859|NCT03288532|Drug|Tremelimumab|controlled infusion via an infusion pump into a peripheral or central vein
15946860|NCT03288506|Behavioral|Google Hangout (VC) group|Feasibility and acceptability of online peer support groups for adults with depression. Groups will be delivered using video-conferencing technology (Google Hangouts).
15946861|NCT03288493|Biological|P-BCMA-101 CAR-T cells|"P-BCMA-101 is an autologous, principally Tscm, CAR-T cell product (also called called a CARTyrin T cell product) targeting the myeloma selective protein BCMA. P-BCMA-101 cells are produced using a non-viral vector carrying the gene for an anti-BCMA Centyrin-based (small, fully human binding domain, designed to increase T cell persistence and decrease exhaustion) chimeric antigen receptor (CAR). Secondary to the large carrying capacity of the non-viral vector, P-BCMA-101 cells carry two additional genes, a selection gene used to manufacture a purified product and a safety switch gene to allow the cells to be eliminated if desired. Rimiducid (safety switch activator) may be administered as indicated."
15946862|NCT03288493|Drug|Rimiducid|Rimiducid (safety switch activator) may be administered as indicated.
15946863|NCT03288480|Drug|PT-112|This is a single arm study
15946864|NCT03288467|Procedure|Root canal treatment with 5% NaOCl|
15946865|NCT03288467|Procedure|Root canal treatment with 1% NaOCl|
15946866|NCT03288454|Drug|Ciraparantag|Ciraparantag (administered over 10 minutes)
15946867|NCT03288454|Drug|Placebo|Saline for injection
15946868|NCT03288454|Drug|Apixaban|Apixaban 10mg given twice daily (q12h)
15946874|NCT03288441|Device|Mechanical measures|Mechanical measures to reduce thrombotic risk including: IVC filter insertion, Intermittent Pneumatic Compression (IPC), Removal of Central venous catheter
15946875|NCT03288441|Drug|Intermediate dose antithrombotic|Reduction in antithrombotic medication dose to prophylactic dose (without changing type). Intermediate dose in between prophylactic and full dose
15946876|NCT03288428|Drug|Nalbuphine|patient controlled analgesia with Nalbuphine
15946877|NCT03288428|Drug|Morphine|patient controlled analgesia with Morphine
15946878|NCT03288402|Other|ongoing fasted state, intake of caffeine containing beverages or 5-item English breakfast|effects of ongoing fasted state; or intake caffeine containing beverages; or 5-item English breakfast on plasma CgA measurements, in series blood tests every 30 min over 180 min
15946879|NCT03288389|Dietary Supplement|NTFactor Lipids®|Membrane Lipid Replacement with NTFactor Lipids wafers
15946880|NCT03288389|Dietary Supplement|Placebo|Placebo wafers
15946882|NCT03288350|Drug|mDCF + Avelumab|Patients will receive neoadjuvant therapy consisting of 4 cycles of avelumab added to the modified chemotherapy regimen of docetaxel, cisplatin, 5-fluorouracil (mDCF), followed by surgery and assessment of pathologic response. Then they will receive 4 cycles of adjuvant therapy of mDCF and avelumab.
15946883|NCT03288324|Drug|Tofacitinib|Tofacitinib 5 mg twice daily
15946884|NCT03288311|Other|Protocolized post-extubation respiratory support|Qualifying patients undergoing extubation in an ICU bed randomized to post-extubation respiratory support will receive either non-invasive ventilation or high flow nasal cannula (as determined by a prespecified protocol and applied by a respiratory therapist) from the time of extubation until 5AM the following morning
15946885|NCT03288311|Other|Usual Care|Qualifying patients undergoing extubation in an ICU bed randomized to usual care will receive standard-of-care treatment, which may include post-extubation respiratory support at the discretion of their clinical team.
15946886|NCT03288298|Drug|luteolin|flavonoid natural extract
15946887|NCT03288298|Drug|nano-luteolin|nanoparticles of luteolin
15946888|NCT03288272|Radiation|Whole Brain Radiotherapy|Radiotherapy of the whole brain
15946889|NCT03288272|Other|Best Supportive Care|Best Supportive Care including nutrition, pain medication, steroids as needed
15946890|NCT03288259|Procedure|transnasal endoscopy|Transnasal endoscopy without sedation with ultra-thin endoscopes in patients who are candidates for bariatric surgery
15946891|NCT03288259|Drug|Local Anesthetics,Topical|Will be carried out topical anesthesia of the pharynx with lidocaine spray (10%) 6 puffs and instillation of nasal vasoconstrictor 4 drops.
15946892|NCT03288246|Diagnostic Test|point-of-care viral load test|A point-of-care viral load test returns viral load test results within 90 minutes.
15946893|NCT03288233|Diagnostic Test|Breath carbon monoxide measurement|Participants will be asked to breath in designed breathing circuits or hold their breath for short period of time and then their breath samples will be collected in special bags and the carbon monoxide and carbon dioxide will be measured with electrochemical techniques.
15946894|NCT03288194|Behavioral|Problem-Solving Treatment|
15946895|NCT03288194|Behavioral|Time Management|
15946896|NCT03288181|Device|Muscle Stretch|The splint will be applied to the affected leg as per the protocol for 30 minutes per day, 5 days per week for 4 weeks.
15946897|NCT03288155|Dietary Supplement|Cocoa|Participants will receive either a high flavonoid cocoa or a low flavonoid placebo cocoa.
15946898|NCT03288142|Other|Lark HTN Pro|The intervention group will have the HPCP installed on their iOS device during their initial office visit (screening/baseline) and will successfully take a reading from their HBMD
15946899|NCT03288129|Drug|Perampanel|film-coated tablets
15946900|NCT03288116|Diagnostic Test|Scheimplug imaging and contrast and sensitivity test|examination of the patients using the schemiplug imaging with evaluation of keratometric parametres ,pachymetric parametres ,elevation parameters.
15946901|NCT03288103|Drug|Norditropin|Single dose of daily growth hormone regimen. Dose will be 50 micrograms/kg/day.
15946902|NCT03288090|Other|FSS: Fatigue Severity Scale|Fatigue scale with 9 items rated from 1 to 7, assessing physical fatigue, fatigue in the psychosocial environment and fatigue in general (3 items in each category).
15946903|NCT03288090|Other|Neuropsychological evaluation battery|A standardized French neuropsychological battery for the cognitive evaluation of stroke patients.
15946904|NCT03288090|Other|Other functional scores|Rankin Score, Instrumental Activities of Daily Living (IADL) Score, Rivermead Mobility Index (RMI) scale, Hospital Anxiety Depression scale (HAD) scale for depression / anxiety, Stroke Specific Quality of Life scale for quality of life, Quality Index of Pittsburgh Sleep (PSQI), Vertical Analog Visual Scale for Pain and Vertical Digital Visual Scale
15946905|NCT03288077|Other|Tryptophan|Beverage including tryptophan
15946906|NCT03288064|Dietary Supplement|Corinthian currant|Supplementation of 1.5 g CHO/kg BW in the form of Corinthian currant prior to exercise
15946907|NCT03288064|Dietary Supplement|Glucose drink|Supplementation of 1.5 g CHO/kg BW in the form of glucose drink prior to exercise
15946908|NCT03288064|Dietary Supplement|Water ingestion|Supplementation of 7ml/kg BW prior to exercise
15946909|NCT03288051|Other|Fluid management|Primary fluid admission: 1 mL/bodyweight kg/ hour crystalloid. If Pulse pressure variation is lower than 10%; 250 mL/15 min of colloid or crystalloid is administered depending on randomization.
15946910|NCT03288051|Drug|Norepinephrine|Norepinephrine is administered if Mean arterial pressure drops below 65 mmHg. Mean arterial pressure must be maintained above 65 mmHg. Norepinephrine is titrated accordingly.
15946911|NCT03288051|Drug|Dobutamine|Dobutamine is administered if Cardiac index drops below 2.5 L/min/m2. Cardiac index must be maintained above 2.5 L/min/m2. Dobutamine is titrated accordingly.
15946912|NCT03288038|Drug|Rosuvastatin|
15946913|NCT03288038|Drug|Ezetimibe|
15946914|NCT03288025|Behavioral|Nutrition and Exercise|5 times a week exercise training and biweekly diet counseling for 12 weeks.
15946915|NCT03287999|Diagnostic Test|Thrombophilia screen|Thrombophilia screen (including antithrombin activity (AT:Ac), protein S antigen (PS:free), protein C activity (PC:Ac) , genetic analysis for FV Leiden and Prothrombin 3'UTR mutations and screening for lupus anticoagulant.
15982327|NCT03019237|Other|intranasal saline|intranasal placebo
15946916|NCT03287999|Diagnostic Test|Initiation pathway analysis|Evaluation of inter-individual variability in regulation of TF.VIIa.Xa.TFPI complex (tissue factor, activated Factor VII, activated factor X, tissue factor pathway inhibitor)
15946917|NCT03287986|Other|MRI|Structural and functional sequences
15946918|NCT03287973|Behavioral|Lifestyle modification|A caloric reduction of 10-20% in daily energy intake from the patient's usual diet (i.e. a deficit ≥ 200 calories per day) will be set as the general initial goal, which will be adjusted subsequently based on changes in body weight with target body mass index (BMI) towards 23 kg/m2.
15946919|NCT03287973|Device|Continuous positive airway pressure (CPAP)|Patients randomized into the continuous positive airway pressure (CPAP) group in each arm will be interviewed by the physician on duty and invited to start autoCPAP treatment for 6 months. They will be offered a CPAP education package. Patients will then commence autoCPAP treatment for 6 months at home.
15946920|NCT03287960|Drug|setmelanotide|Once daily subcutaneous injection
15946921|NCT03287960|Drug|Placebo|During the double blind placebo withdrawal period, patients will receive RM-493 or placebo at variable times over an 8 week period
15946922|NCT03287947|Drug|nintedanib|Oral nintedanib, taken twice daily
15946923|NCT03287934|Device|selective laser sintered stent|after planning and virtual implant placement, a guide will be designed and the STL file will be send to prototyping center for printing the guide with selective laser sintering technique. during the surgical procedure , the target tooth will be atraumatic extracted, the stent is adapted in its place then implant drilling and placement will be done.
15946924|NCT03287934|Device|digital light processing(dlp)|after planning and virtual implant placement, a guide will be designed and the STL file will be send to prototyping center for printing the guide with digital light processing technique. during the surgical procedure , the target tooth will be atraumatic extracted, the stent is adapted in its place then implant drilling and placement will be done.
15946925|NCT03287921|Drug|mono bronchodilatation|within indication according to current GOLD recommendation
15946926|NCT03287921|Drug|dual bronchodilatation|within indication according to current GOLD recommendation
15946927|NCT03287908|Drug|AMG 701|Subjects will receive IV infusions of AMG 701.
15946928|NCT03287908|Drug|Pomalidomide|Subjects will receive oral capsules of pomalidomide.
15946929|NCT03287908|Drug|Dexamethasone|Subjects will receive IV injections or oral dexamethasone.
15946930|NCT03287895|Behavioral|Decision Support|A two-part intervention to help patients make better decisions about CPR
15946931|NCT03287882|Dietary Supplement|Multiple micronutrients (UNIMMAP composition)|The intervention is an oral tablet containing 15 different vitamins and minerals at the UNIMMAP composition (includes 30 mg iron, 400 μg folic acid, 15 mg zinc, 2 mg copper, 65 μg selenium, 800 μg RE vitamin A, 1.4 mg vitamin B1, 1.4 mg vitamin B2, 18 mg niacin, 1.9 mg vitamin B6, 2.6 μg vitamin B12, 70 mg vitamin C, 5 μg vitamin D, 10 mg vitamin E and 150 μg iodine). Each tablet is small (approximately 10 mm diameter) and has been procured using the UNICEF supply catalogue. A single MMN supplementation dose will consist of a single tablet.
15946932|NCT03287882|Behavioral|Life skills based education|The life skills based education will be provided bi-monthly in the format of a group session throughout the preconception period. Three topic areas related to empowerment have been prioritized, including preventing early marriage; personal and menstrual hygiene practices; and the importance of nutrition to good health. Integrated within these topics will be messages related to the importance of continuing one's education, mental health, gender norms and equality, decision making, advocacy, resiliency, participation, communication skills, facing challenges, agency, conflict resolution, and the prevention of violence.
15946933|NCT03287869|Drug|Brexpiprazole|Brexpiprazole tablets
15946934|NCT03287856|Device|Transcatheter Aortic Valve Implantation (TAVI)|Implantation of the ALLEGRA Transcatheter Heart Valve in failing surgical bioprosthesis
15946935|NCT03287843|Procedure|Total mesorectal excision before 56 days (4-8 weeks)|Low anterior resection or abdominoperineal resection
15946936|NCT03287843|Procedure|Total mesorectal excision after 56 days (8-12 weeks)|Low anterior resection or abdominoperineal resection
15946937|NCT03287830|Behavioral|Text message influenza vaccine reminders|Text message reminders for second dose of influenza vaccination
15946938|NCT03287817|Biological|AUTO3|Following preconditioning with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with doses from 50 x 10⁶ to 900 x 10⁶ CD19/ CD22 Chimeric Antigen Receptor (CAR) positive T cells followed by limited duration of anti-PD1 antibody (pembrolizumab).
15946939|NCT03287804|Biological|AUTO2|"AUTO2 (APRIL CAR T Cells) Following preconditioning with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with doses from 15 x 10⁶ to 350 x 10⁶ APRIL CAR T Cells.
~Following Phase 2 dose determination patients will be treated with selected dose of APRIL CAR T Cells"
15946940|NCT03287791|Drug|Generic Azelaic Acid Foam|Topical foam, generic formulation of the brand product.
15946941|NCT03287791|Drug|Finacea® (Azelaic Acid) Foam|Topical foam, brand product.
15946942|NCT03287791|Drug|Vehicle Foam|Topical foam, placebo. Has no active ingredient.
15946943|NCT03287791|Other|Cleanser|A mild cleanser provided to participants, so they can wash their face prior to applying the study drug.
15946944|NCT03287791|Other|Sunscreen|Sunscreen provided to participants, so they can apply it to their face when outdoors.
15946945|NCT03287791|Other|Towel|A soft towel provided to participants, so they can pat their face dry after washing and prior to applying the study drug.
15946946|NCT03287791|Other|Moisturizing Lotion|Moisturizing lotion provided to participants, so they can apply it to their face, as needed.
15946947|NCT03287778|Dietary Supplement|Pyridoxine|Max dose of 400 mg QD PO
15946948|NCT03287778|Dietary Supplement|Placebo|Matching placebos will be administered.
15946949|NCT03287765|Drug|18F-AV-1451|Participants will receive a single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807. For those who cannot tolerate the full exam, participants will receive single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807.
15946952|NCT03287739|Behavioral|Assessment of behavioral biometric impairments|Assessment of behavioral biometric impairments
15946953|NCT03287726|Dietary Supplement|probiotics|NYCOPRO, a multistrain probiotic (7 strains of Lactobacilli and Bifidobacteria) sold in the Norwegian pharmacies. 2 capsules/day (one with lunch and one with dinner). 2 text messages daily as a reminder. Follow up meeting at ObeCe (St. Olavs hospital) every month with a research nurse, for weighing, blood pressure measurement and collection of probiotics dose for the following month.
15946954|NCT03287726|Dietary Supplement|placebo|Placebo 2 capsules/day (one with lunch and one with dinner). 2 text messages daily as a reminder. Follow up meeting at ObeCe (St. Olavs hospital) every month with a research nurse, for weighing, blood pressure measurement and collection of probiotics dose for the following month.
15946955|NCT03287713|Drug|oxygen therapy|conventional nasal prongs vs nasal high flow oxygen during Pulmonary Rehabilitation in Interstitial Lung Disease.
15946956|NCT03287700|Other|No intervention|No intervention will be administered to any group in this observational study.
15946957|NCT03287687|Drug|Carbon dioxide gas for insufflation|Carbon dioxide gas use for insufflation during endoscopy instead of air
15946958|NCT03287687|Drug|Air|Air is the standard of practice and will be used in the control arm
15946959|NCT03287674|Drug|Cyclophosphamide|Cyclophosphamide 60 mg/kg is administered i.v. on day -7 and day -6.
15946960|NCT03287674|Drug|Fludarabine|Fludarabine 25 mg/m2 is administered on day -5 to day -1.
15946961|NCT03287674|Biological|TIL infusion|The maximum number of expanded TILs are infused over 30-45 minutes on day 0.
15946962|NCT03287674|Drug|Interleukin-2|Interleukin-2 is administered as a daily low-dose subcutaneous injection of 2 MIU for a total of 14 days.
15946963|NCT03287674|Drug|Ipilimumab|One dose of Ipilimumab 3 mg/kg is administered 14 days prior to surgical removal of tumor tissue for TIL expansion.
15946964|NCT03287674|Drug|Nivolumab|Nivolumab 3 mg/kg is administered on day -2 before TIL infusion and every 2 weeks for a total of 4 doses.
15946965|NCT03287661|Behavioral|Acceptance-based Behavioural Therapy|The treatment program is an eight module (8-week) ABBT for chronic pain. The online treatment material is administered via the WebCAPSI Therapy program. This online program allows participants to progress through the treatment modules at their own pace. Each module is designed to cover a specific component of ABBT and will facilitate understanding of the components through audio files, veteran, military and RCMP-specific vignettes, text-based material, and homework exercises/assignments. Each module is designed to be completed in 60 minutes or less. On the completion of each module, and facilitated through the WebCAPSI Therapy program, the participants are asked to complete a homework exercise to which they answer questions previously encountered throughout the module. The principle therapist responds to each homework exercise within 24-hours of its online submission.
15946966|NCT03287648|Diagnostic Test|optical coherence tomography and blue-fundus autofluorescence|Simultaneous infra-red and optical coherence tomography (cube and radial pattern) centered on the fovea Simultaneous fundus autofluorescence and optical coherence tomography (radial pattern) centered on the fovea
15946967|NCT03287635|Drug|Corticotropin 80Unit/Ml Repository Injection|H.P. Acthar Gel (repository corticotropin injection) is an adrenocorticotropic hormone (ACTH) analogue used for: Treatment during an exacerbation or as maintenance therapy in selected cases of systemic lupus erythematosus.
15946968|NCT03287622|Behavioral|Educational Intervention|This intervention provides scenario-tailored opioid risk message feedback immediately following interactive analgesic decision-making exercises.
15946969|NCT03287622|Behavioral|Nudge|Behavioral Nudge in this study is a simple, take-home kit (ziplock baggy of used coffee grounds) to be used to dispose of left-over prescription opioids
15946970|NCT03287609|Drug|Evolocumab 140 mg/mL|Three injections with pre-filled auto-injector pen at day 1 and at week 4.
15946971|NCT03287609|Drug|Placebo|Three injections with pre-filled auto-injector pen at day 1 and at week 4.
15946972|NCT03287596|Device|MRI ZTE2 sequence|feasibility of ZTE 2 sequence to quantitatively assess normal and pathological spondyloarthropathy
15946973|NCT03287583|Behavioral|SBIRT for Gambing|The SBIRT intervention uses a brief gambling screening assessment to determine whether or not a participant is at risk for problem gambling. This is followed by a structured short brief intervention to assist people in better understanding their risk for gambling and what they can do to limit that risk.
15946974|NCT03287583|Other|Enhanced Control|Participants randomized to the enhanced control condition will receive a handout with gambling resources.
15946975|NCT03287570|Device|Cettum|The treatment is applied twice a week for 15 minutes for 6 weeks (12 sessions). 6 points (ST36, ST35, EX-LE4, SP9, SP10, ST34) are used for all the patients assigned to this group and investigator can be added up to 2 points depending on the patient condition. Electric moxibustion, Cettum (20X28X18mm) manufactured by K-medical Co.(Korea) is used.
15946976|NCT03287570|Procedure|Traditional indirect moxibustion|The treatment is applied twice a week for 6 weeks (12 sessions). 6 points (ST36, ST35, EX-LE4, SP9, SP10, ST34) are used for all the patients assigned to this group and investigator can be added up to 2 points depending on the patient condition. Traditional indirect moxibustion, Taekeukttum manufactured by Haenglim Seowon Medical Co.(China) is used. A total of three moxibustion cones are applied indirectly to each point per treatment session.
15946977|NCT03287570|Other|Usual care|The patients in this group maintain the usual treatment and self-care.
15946978|NCT03287544|Other|Combined rehabilitation|Linguistic training as well as communication training.
15946979|NCT03287544|Other|Linguistic rehabilitation|Rehabilitation only focused on linguistic processes.
15946980|NCT03287531|Other|conventional therapy|Exercise therapeutic Ultrasound
15946981|NCT03287531|Other|low level laser therapy|LLLT with the appropriate parameters (904 nm, 8 j/cm2, 250mw) for duration of 20 min with repletion of three treatment sessions per week.
15946982|NCT03287518|Dietary Supplement|WAK2017|WAK2017 is a solution with following active ingredients: Aged Garlic Extract. One (1) ml IP should be taken with breakfast and one (1) ml with supper every day
15946983|NCT03287518|Dietary Supplement|Placebo|One (1) ml IP should be taken with breakfast and one (1) ml with supper every day
15946984|NCT03287505|Drug|Aripiprazole IM Depot|administration of Aripiprazole IM Depot formulation at doses of 300 and 400mg once in patients with schizophrenia.
15946985|NCT03287492|Other|Informational Intervention|Receive QPS
15946986|NCT03287492|Other|Informational Intervention|Receive GIS
15946987|NCT03287492|Other|Questionnaire Administration|Ancillary studies
15946988|NCT03287479|Procedure|Gavi® Vitrification|A closed, semi-automated vitrification system
15946991|NCT03287453|Other|Educational Intervention|View an inflatable colon interactive exhibit, PowerPoint presentation, flip books, and flipcharts
15946992|NCT03287453|Other|Survey Administration|Ancillary studies
15946993|NCT03287440|Behavioral|COPD Wellness|This is low-intensity pulmonary rehabilitation that incorporates exercise, nutrition, patient education, and a support group class.
15946994|NCT03287440|Behavioral|Health Advocate|The Zuckerberg San Francisco General (ZSFG) Hospital Health Advocates program links social needs screening with a tiered referral and linkage process to appropriate resources
15946995|NCT03287427|Drug|TetMYB Vaccine|Weekly intra-dermal injections of either 0.1mg, 0.5mg or 1.0mg on day 1 for week 1 to week 6.
15946996|NCT03287427|Drug|BGB-A317|3 weekly IV injections of 200mg commencing from Week 4.
15946999|NCT03287401|Device|Electroencephalography|Patients electroencephalogram will be recorded
15947000|NCT03287388|Procedure|No Rocuronium|Phase 1: The patient will undergo a routine MRI-abdomen without neuromuscular blockade: TOF ratio =1.
15947001|NCT03287388|Drug|Rocuronium (moderate NMB)|Phase 2: Rocuronium will be titrated to a moderate NMB (TOF 1-3), monitored by TOF-watch. When an adequate moderate NMB is achieved, the patient will undergo a second MRI-abdomen.
15947002|NCT03287388|Drug|Rocuronium (deep NMB)|Phase 3: The patient receives a bolus of 1.2 mg/kg rocuronium (adjusted to ideal body weight), to assure a deep or intense NMB (PTC 0-1). Then the patient will undergo the final, third MRI scan of the abdomen.
15947003|NCT03287375|Drug|PIPAC|
15947004|NCT03287362|Behavioral|schema therapy|The intervention consists of a seven-week program of schema therapy, which is a further development of cognitive behavioral therapy, designed in a three-phase combined group and single session concept
15947005|NCT03287362|Behavioral|cognitive behavioral therapy|The intervention consists of a seven-week program of cognitive behavioral therapy, which is the current gold standard of treatment
15947006|NCT03287362|Behavioral|individualized supportive therapy|The intervention consists of a seven-week program of individualized supportive therapy, including different therapeutic offers from the clinic and a high frequency of physician contacts.
15947007|NCT03287349|Other|Blood draw|Two 12.5 mL blood draws
15947008|NCT03287349|Other|Photograph|Photograph of severe reaction, will be anonymized
15947009|NCT03287349|Diagnostic Test|Autoimmune testing|Autoimmune testing in patients without prior testing
15947010|NCT03287336|Drug|Tranexamic Acid|Tranexamic acid dosage (5 mg/kg, 10 mg/kg and 15 mg/kg) administered in a dose escalating fashion by cohort with the lowest dose first.
15947011|NCT03287323|Other|Proactive Palliative Care|In the intervention part of the study, enrolled patients will be offered a set of different palliative care interventions, including symptom management, advance care planning, palliative physiotherapy, social and spiritual support, communication with patients and caregivers, in addition to standard intensive care.
15947012|NCT03287310|Drug|GSK3511294|GSK3511294 will be available as a clear or opalescent, colorless or yellow to brown solution for injection at unit dose strength of 150 milligrams per milliliter (mg/mL). GSK3511294 will be diluted in 0.9% weight by volume (w/v) sodium chloride to achieve the desired concentration for administration. GSK3511294 will be administered by SC injection.
15947013|NCT03287310|Drug|Placebo|Matching Placebo will consist of 0.9% w/v sodium chloride which will be administered by the SC route.
15947014|NCT03287310|Drug|Salbutamol/albuterol|Salbutamol/albuterol will be supplied to all subjects for use as rescue medication during the study.
15947015|NCT03287297|Diagnostic Test|OGTT & HBA1c|oral glucose tolerance test & HBA1c: by measuring glycated hemoglobin
15947016|NCT03287284|Device|Active Low Level Laser Therapy|Active application of Low Level Laser Therapy with a dose of 240 Joules
15947017|NCT03287284|Behavioral|Resistance Training|Resistance Training
15947018|NCT03287284|Device|Placebo Low Level Laser Therapy|Placebo application of Low Level Laser Therapy
15947019|NCT03287271|Drug|VS-6063|"Phase 1:
~First 3 patient cohort: VS-6063 200 mg PO twice daily
~IF TOLERATED, Second 3 patient cohort: VS-6063 400 mg PO twice daily,
~Phase 2:
~VS-6063 400 mg PO twice daily of a 28 day cycle until disease progression or unacceptable toxicity."
15947020|NCT03287271|Drug|Paclitaxel|"Phase 1:
~First 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
~IF TOLERATED, Second 3 patient cohort: paclitaxel 80 mg/m2 infused IV continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle.
~Phase 2:
~Paclitaxel 80 mg/m2 infused continuously over 1 hour on days 1, 8, and 15 of a 28 day cycle until disease progression or unacceptable toxicity."
15947021|NCT03287271|Drug|Carboplatin|"Phase 1:
~First 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
~IF TOLERATED, Second 3 patient cohort: carboplatin (AUC of 5 mg/mL/min) IV infused continuously over 1 hour on day 1 of a 28 day cycle.
~Phase 2: carboplatin (AUC of 5 mg/mL/min) infused continuously over 1 hour on day 1 of a 28 day cycle until disease progression or unacceptable toxicity."
15947022|NCT03287258|Other|3 program|The participants will receive 3 programs.The educational pelvic floor dysfunction prevention program, pelvic floor muscle exercise program and perineal massage program will be educated by an investigator during the participant visit 4 weeks before her due date
15947023|NCT03287258|Other|one program|The participants will receive one program. That is the educational pelvic floor dysfunction prevention program.The instructions of the program will be given by an investigator once during the participant visit 4 weeks before her due date.
15947025|NCT03287232|Drug|Placebo Vaginal Insert|Daily administration of a placebo vaginal insert.
15947026|NCT03287232|Drug|Prasterone 6.5 mg (0.50%) Vaginal Insert|Daily administration of a 6.5 mg (0.50%) prasterone vaginal insert.
15947027|NCT03287219|Drug|Methylene Blue MMX 25 mg modified release tablets|Methylene Blue MMX 25 mg modified release tablets administered with a full dose regimen of a 4-L PEG-based bowel cleansing preparation.
15947031|NCT03287193|Genetic|high-throughput sequencing|exome or whole genome sequencing
15947032|NCT03287180|Behavioral|Adolescent Community Reinforcement Approach (A-CRA)|The A-CRA is a modified version of the Community Reinforcement Approach for adolescents and transitional age youth. The A-CRA treatment protocol consists of nineteen procedures designed to promote positive behavior change directed towards prosocial activities and engagement in the individual's community. A community can include but is not limited to: social and peer activities, family interaction, and work or school environments. Some of the highlighted procedures include relapse prevention, sobriety sampling, problem solving, and communication skills. There are also combined parent/and or couples relationship sessions with the young adult. In the current study, 12-weeks of A-CRA treatment will be provided to the intervention group.
15947033|NCT03287180|Other|Combination of buprenorphine/naloxone 4/1|Buprenorphine is a partial agonist at mu-opioid receptor, an antagonist at kappa-opioid receptor. Naloxone is an antagonist at the mu-opioid receptor. Buprenorphine/naloxone requires the use of an induction to avoid the risk of withdrawal. Participants are instructed not to use opioids for at least 10 hours prior to first dose. Once symptoms of withdrawal score a minimum of 7 on the Clinical Opiate Withdrawal Scale (COWS), the first dose of 4/1 mg will be given. Participants will be monitored for an hour. An additional 4/1 mg dose can be provided to a dose that suppresses withdrawal effects. The physician then provides a prescription for 8/2-16/4 mg for Day 2. Doses can be adjusted with a maximum of total 24/6 mg/day. The target daily dose is 16/4 mg.
15947034|NCT03287167|Drug|1 month DAPT|Subjects will continue DAPT with clopidogrel and Aspirin (ASA) up to 1 month, after which patients will be given ASA and placebo in next 5 months and then continue on monotherapy with ASA only, unless contraindications for ASA emerge.
15947035|NCT03287167|Drug|6 months DAPT|Subjects will continue DAPT with clopidogrel and Aspirin (ASA) up to 6 months, after which patients will continue on monotherapy with ASA only, unless contraindications for ASA emerge.
15947036|NCT03287154|Device|Active tDCS stimulations|20 min, 2mA
15947037|NCT03287154|Device|Sham tDCS|20 min, Sham
15947038|NCT03287141|Diagnostic Test|Shuttle walk test|A shuttle walk test was performed without any previous intervention.
15947039|NCT03287141|Device|Noninvasive ventilation (Bi-pap)|After 30 minutes of the mentioned intervention, the subject performed a shuttle walk test.
15947040|NCT03287141|Device|Noninvasive ventilation (CPAP)|After 30 minutes of the mentioned intervention, the subject performed a shuttle walk test.
15947041|NCT03287128|Drug|Gemtuzumab Ozogamicin (GO)|patients included in a compassionate patient named program with GO
15947042|NCT03287115|Other|Broccoli consumption|All subjects will eat broccoli on day 11
15947043|NCT03287102|Procedure|Macular hole surgery|Vitrectomy, temporal inverted or complete ILM peeling and gas tamponade
15947044|NCT03287089|Drug|Nitrofurantoin 100 MG|Patients will receive nitrofurantoin 100mg twice daily by mouth for 5 days
15947045|NCT03287089|Drug|Placebo Oral Tablet|Matching placebo
15947046|NCT03287076|Drug|Exenatide Injection|5μg subcutaneously twice daily for five days, commencing within 9 hours of symptom onset
15947047|NCT03287063|Other|Tumor Biopsy|Stereotactic biopsies will be performed prior to resection.
15947048|NCT03287050|Drug|Pembrolizumab|200 mg IV q 21 days
15947049|NCT03287050|Radiation|SBRT|Stereotactic body radiation therapy (SBRT) that will commence not later than the initiation of the second cycle of pembrolizumab. SBRT dose and fractionation will be at the discretion of the treating radiation oncologist, and will be selected to respect the normal tissue tolerance of adjacent organs at risk.
15947050|NCT03287037|Device|tDCS over DLPFC|We applied tDCS over dorsolateral prefrontal cortex (DLPFC) for these depressed patients. Direct current (DC) generated by a DC stimulator (Eldith DC stimulator: www. neuroconn.de/dc-stimulator_plus_en/) was bilaterally delivered through a pair of saline-soaked surface sponge electrodes (35 cm2). The anodal electrode was placed over the left dorsolateral prefrontal cortex (F3, International EEG System 10-20) and cathode electrode over F4. Stimulation was applied at an intensity of 2 mA for 20 min, twice-daily on 5 consecutive weekdays. The twice daily sessions were separated by at least 3 hours. All patients were maintained on their treatment throughout the study period.
15947051|NCT03287024|Device|BeGrow Stent System|All enrolled subjects will undergo primary stenting of the target lesion by placement of the BeGrow Stent System
15947052|NCT03287011|Other|Shoplaq toothpaste|"ACTIVE INGREDIENT Sodium Monofluorophosphate 1000 PPM INGREDIENTS Precipitated Calcium Carbonate, Sorbitol, Glycerin, Precipitated Silica, Sodium Carboxy Methyl Cellulose, Sodium Benzoate, DM Water, Colour CI-45410, Holy Basil Oil, Neem Oil, Citrus Oil, Thymol Oi, Clove Oil, Piper Betel Leaf Oil, Tea Tree Oil, Eucalyptus Oil, Peppermint Oil, Spearmint Oil.
~Dye containing tooth paste for disclosing plaque and efficient brushing for better oral health."
15947053|NCT03287011|Other|Colgate toothpaste|fluoridated
15947054|NCT03286972|Device|PET/MRI|Participants will be placed in standard non-ferrous head and neck immobilization devices during PET/MRI (to simulate their anticipated positioning during subsequent CT simulation and treatment). A head/neck PET/MRI (standard bore size, 60 cm) will be performed
15947055|NCT03286959|Procedure|PCR with calcium hydroxide|
15947056|NCT03286959|Procedure|PCR with RMGIC|
15947057|NCT03286959|Procedure|PCR with direct composite|
15947058|NCT03286946|Procedure|block with Blunt-type block needle.|Under fluoroscopic guidance, cervical transforaminal epidural injections were performed using 22 gauge blunt needle. The needle position was confirmed using biplanar fluoroscopy and 2 ml of nonionic contrast media was injected to detect intravascular injection.
15947059|NCT03286946|Procedure|block with sharp-type block needle.|Under fluoroscopic guidance, cervical transforaminal epidural injections were performed using 22 gauge sharp needle. The needle position was confirmed using biplanar fluoroscopy and 2 ml of nonionic contrast media was injected to detect intravascular injection.
15947060|NCT03286933|Behavioral|yoga|75 minute weekly group yoga classes for 8 weeks. Home program online.
15947061|NCT03286920|Dietary Supplement|Oral nutrition supplement|As for patients in oral nutrition supplement group, in addition to oral natural die, the participants shall receive oral enteral supplement providing 750-1500kcal/d.
15947062|NCT03286920|Dietary Supplement|Tube feeding nutrition supplement|As for patients in tube feeding group, in addition to oral natural die, the participants shall receive Tube feeding nutrition supplement providing 750-1500kcal/d.
15947301|NCT03284957|Drug|Amcenestrant|"Pharmaceutical form: capsule
~Route of administration: oral"
15947063|NCT03286907|Behavioral|Online videos|Watch two online short health promotion videos (five minutes each), complete a self-administered online exercise and receive reminders at month 1, 2, 4, 6 & 8.
15947064|NCT03286907|Behavioral|Online videos and MI|Watch two online short health promotion videos (five minutes each), complete a self-administered online exercise, receive 15 minutes motivational interviewing through telephone and reminders at month 1, 2, 4, 6, & 8.
15947065|NCT03286907|Behavioral|Control group|Receive online health communication messages about prevalence of some common mental health problems among MSM and introduction of stress reduction exercises
15947066|NCT03286881|Other|Brief individual psychotherapy|"Individual brief psychological intervention by adaptation of the Guide NICE Common Mental Health Disorders (ISBN 978-1-84936-585-7) and the unified protocol for the trasndiagnostic treatment of the emotional disorders of Barlow (Boisseau, Farchione, Fairholme, Ellard, y Barlow, 2010). This intervention is provided by clinical psychologist in secondary care."
15947067|NCT03286881|Other|Brief group psychotherapy|"Group brief psychological intervention by adaptation of the Guide NICE Common Mental Health Disorders (ISBN 978-1-84936-585-7) and the unified protocol for the trasndiagnostic treatment of the emotional disorders of Barlow (Boisseau, Farchione, Fairholme, Ellard, y Barlow, 2010). This intervention is provided by clinical psychologist in primary care."
15947068|NCT03286881|Other|Combined intervention|Traditional psychotherapy and medication provided by a clinical psychologist and a psychiatrist in secondary care.
15947069|NCT03286881|Other|Minimum psychological intervention|Psychoeducation and bibliotherapy provided by a trained general practitioner in primary care.
15947070|NCT03286881|Other|Usual treatment|Medication provided by a general practitioner.
15947071|NCT03286868|Procedure|Total Knee Arthroplasty|Total Knee Arthroplasty
15947072|NCT03286868|Device|Total Knee Arthroplasty with Verasense sensor|Total Knee Arthroplasty with Verasense sensor
15947073|NCT03286855|Device|Vibrating Mesh Nebuliser|The Aerogen Ultra vibrating mesh nebuliser is an approved 13 485 class II medical device (CE marked) nebuliser licenced for the delivery of physician-prescribed medications for inhalation which are approved for use with a general purpose nebuliser. It has been shown in previous laboratory and clinical studies to have superior drug delivery to standard jet nebulisers.
15947074|NCT03286855|Device|Standard Hospital Care|"The standard hospital care refers to the nebuliser in clinical use currently throughout Beaumont Hospital and used for the administration of nebulised medications. This is the Hudson micromist small volume nebuliser."
15947075|NCT03286842|Drug|Olaparib|Patients will be administered olaparib orally, twice daily at 300 mg. Two (2) 150 mg olaparib tablets should be taken at the same time each morning and evening of every day, approximately 12 hours apart.
15947076|NCT03286829|Drug|"Tesomet High dose in fasted condition"|To evaluate the PK profile and relative bioavailability of a single dose of the Tesomet fixed-dose combination (FDC) tablet and co-administration of tesofensine plus commercial metoprolol.
15947077|NCT03286829|Drug|"Tesomet Low dose in fasted condition"|To evaluate the PK profile and relative bioavailability of a single dose of the Tesomet fixed-dose combination (FDC) tablet and co-administration of tesofensine plus commercial metoprolol.
15947078|NCT03286829|Drug|Comperator 1 mg tesofensine, 25 mg commercial IR metoprolol, 75 mg commercial ER metoprolol, fasted condition.|To evaluate the PK profile and relative bioavailability of a single dose of the Tesomet fixed-dose combination (FDC) tablet and co-administration of tesofensine plus commercial metoprolol.
15947079|NCT03286829|Drug|"Tesomet High dose in fed condition"|To evaluate the PK profile and relative bioavailability of a single dose of the Tesomet fixed-dose combination (FDC) tablet and co-administration of tesofensine plus commercial metoprolol.
15947080|NCT03286816|Drug|SodiumChloride|
15947081|NCT03286816|Drug|Sodium Lactate|
15947082|NCT03286803|Biological|Inactivated Poliovirus vaccine|we will administer either full dose (0.5ml) or fractional dose (0.1ml) of inactivated poliovirus vaccine
15947083|NCT03286790|Other|Data collection on pneumonia events|
15947084|NCT03286777|Dietary Supplement|Placebo|Mannitol and silicon dioxide capsules
15947085|NCT03286777|Dietary Supplement|Native 6-prenylnaringenin|250 mg native 6-PN plus mannitol and silicon dioxide capsules
15947086|NCT03286777|Dietary Supplement|Micellar 6-prenylnaringenin|250 mg 6-PN in a micellar formulation with Tween-80 as adjuvant capsules
15947087|NCT03286764|Other|Peppermint Oil|
15947088|NCT03286764|Other|Distilled water|Distilled water spray as a placebo during Colonoscopy
15947089|NCT03286751|Drug|LY900014|Administered SC
15947090|NCT03286751|Drug|Insulin Lispro|Administered SC
15947091|NCT03286738|Drug|FOLFIRI, target agent|"Irinotecan (Camtop Injection®, CJ HealthCare Corp.), Leucovorin, 5-Fluorouracil and Bevacizumab
~Irinotecan (Camtop Injection®, CJ HealthCare Corp.), Leucovorin, 5-Fluorouracil and Cetuximab"
15947092|NCT03286725|Behavioral|Physical Education (PE) Programme|"A programme of activities for PE lessons has been developed by Oxford Brookes University (in collaboration with Oxfordshire Sport and Physical Activity) to try to optimise the benefit of PE for brain function. Staff from Oxford Brookes University will train PE teachers to deliver this programme.
~The Intervention involves roughly 20 minutes of prescribed activities per week, to be delivered within school PE lessons."
15947093|NCT03286712|Drug|Renogen|Administration of erythropietin alpha to see the effect on the hemoglobin level and vascular reactivity
15947094|NCT03286699|Behavioral|Dietary Intervention|The behavioral weight loss intervention strategies will not be limited to, self-monitoring, goal setting, problem solving, mastery skills, social support, and relapse prevention. Participants will receive a standard behavioral weight control program, delivered on a one-on-one basis. They will attend in-person sessions (~30-45 minutes) with time to: distribute intervention materials, interact with the participant, identify participants that need additional support, and conduct the intervention. Each in-person visit focuses on a specific behavioral topic related to weight loss to address eating behaviors. Subjects will also participate in phone calls with the interventionist (~10 minutes). Depending on the week, subjects will have between 10 and 45 minutes of total intervention contact.
15947136|NCT03286413|Procedure|microwave ablation|Microwave ablation and cryoablation are both thermal ablation techniques for minimally invasive treatment of breast tumor. They are performed percutaneously by ultrasound guidance.The tumor can be completely killed without injurying adjacent tissue.
15947302|NCT03284957|Drug|Palbociclib|"Pharmaceutical form: capsule
~Route of administration: oral"
15947095|NCT03286699|Behavioral|Physical Activity Intervention|The behavioral weight loss intervention strategies will not be limited to, self-monitoring, goal setting, problem solving, mastery skills, social support, and relapse prevention. Participants will receive a standard behavioral weight control program, delivered on a one-on-one basis. They will attend in-person sessions (~30-45 minutes) with time to: distribute intervention materials, interact with the participant, identify participants that need additional support, and conduct the intervention. Each in-person visit focuses on a specific behavioral topic related to weight loss to address physical activity behaviors. Subjects will also participate in phone calls with the interventionist (~10 minutes). Depending on the week, subjects will have 10 to 45 minutes of total intervention contact.
15947096|NCT03286686|Behavioral|point targets|In the experiences 1 and 2, the participant needs to point different visual targets (LED) in the dark.
15947097|NCT03286686|Behavioral|tactile stimulation|In the experience 3, a tactile stimulation is applied to the middle finger of the 2 hands. The participant needs to indicate into a microphone when he feels the stimulation.
15947098|NCT03286686|Behavioral|visual images|Target dots or visual images are presented on a computer screen. The participant is required to point to the targets or to react as soon as possible by pressing a response button when they are detected.
15947099|NCT03286673|Dietary Supplement|calcium phosphate|
15947100|NCT03286673|Dietary Supplement|Tricalcium Phosphate|
15947101|NCT03286673|Dietary Supplement|Calcium carbonate|
15947102|NCT03286673|Dietary Supplement|Placebo|
15947103|NCT03286660|Diagnostic Test|Chair Rise Tests and short questionnaire|"Exercises consist on a Chair Rise Tests and short questionnaire It is a functional test evaluating the number of chair rise over a given time and / or frequency.
~This test is combined with a questionnaire to collect quantitative and qualitative information:
~dyspnea and muscular fatigue at rest before the start of the test and at the end of the exercise
~Saturation at rest, and at the end of the exercise
~the number of total a chair rise"
15947104|NCT03286647|Procedure|Oral hygiene instruction|the participants will receive instructions to perform a satisfatory oral hygiene
15947105|NCT03286634|Drug|Daunorubicin|Given IV
15947106|NCT03286634|Drug|Prednisolone|Given PO or IV
15947107|NCT03286634|Drug|Vincristine|Given IV
15947108|NCT03286634|Drug|Epirubicin|Given IV
15947109|NCT03286634|Drug|E-coli L-asparaginase|Given IM or IV
15947110|NCT03286634|Drug|6-Mercaptopurine|Given PO
15947111|NCT03286634|Drug|Methotrexate|Given IV, PO or IT
15947112|NCT03286634|Drug|Hydrocortisone|Given IT
15947113|NCT03286634|Drug|Cytarabine|Given IV, IT or SC
15947114|NCT03286634|Drug|Cyclophosphamide|Given IV
15947115|NCT03286621|Other|Administration of five eye-tracking paradigms|All subjects will undergo the battery of five eye-tracking paradigms to determine potential markers for autism.
15947116|NCT03286608|Other|observational study (no intervention)|Statistical association between adherence to a pattern of polyphenol intake and the risk to develop dementia and Alzheimer's disease over 12 years
15947117|NCT03286595|Other|Mobi mHealth app|"Mobile application (i.e. the app) that patients interact with via their smartphone to collect daily and weekly survey information. Data is visualized on a clinician-facing Dashboard, which can be used to inform treatment."
15947118|NCT03286582|Drug|AC-203 1% Topical Ointment|AC-203 1% ointment BID (twice daily)
15947119|NCT03286582|Drug|Clobetasol 0.05% Topical Ointment|Clobetasol 0.05% Topical Ointment BID
15947120|NCT03286569|Device|Upper arch Wilson quadhelex appliance|Upper arch Wilson quadhelex appliance
15947121|NCT03286556|Drug|Autoantibody Reductive Therapy|TPE x 9, rituximab x 2, IVIG x 4. See arm/group descriptions for additional details.
15947122|NCT03286556|Drug|Treatment as Usual (TAU)|Antibiotics and steroids
15947123|NCT03286543|Device|SPRINT Beta System|"The SPRINT Beta System is an Investigational Device which delivers mild electrical stimulation to nerves in the leg that underwent lead placement. The SPRINT Beta System includes a small wire (called a Lead) that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Beta Stimulator)."
15947124|NCT03286530|Drug|Ruxolitinib|"Patients who fulfill eligibility criteria will be entered into the trial to receive Ruxolitinib.
~After the screening procedures confirm participation in the research study. The participant will be given a drug diary. The participant will be asked to document information in the drug diary about the study treatment."
15947125|NCT03286517|Biological|Kisspeptin-10 (metastin 45-54, Calbiochem, Darmstadt, Germany)|A neurohormone
15947126|NCT03286504|Behavioral|FANMI - Cohort Care|FANMI includes receiving integrated clinical care, group counseling, and social activities in a single session by the same provider to simplify care and strengthen relationships between peers and providers. FANMI groups consist of 5-10 adolescents meeting once per month.
15947127|NCT03286491|Diagnostic Test|Further cardiac imaging|Study patients will be reviewed whether they will have coronary interventions in 30 days
15947128|NCT03286478|Behavioral|Mindfulness|Mindfulness-based body image intervention to be delivered 1 lesson per week for 5 weeks (5 x 45 minute lessons), by trained school teachers.
15947129|NCT03286478|Behavioral|Dissonance|Dissonance-based body image intervention to be delivered 1 lesson per week for 5 weeks (5 x 45 minute lessons), by trained school teachers.
15947130|NCT03286478|Behavioral|Dove Confident Me|Dove Confident Me body image intervention to be delivered 1 lesson per week for 5 weeks (5 x 45 minute lessons), by trained school teachers.
15947131|NCT03286465|Device|Pediatric phlebotomy tubes|Use of pediatric size tubes for diagnostic blood collection.
15947132|NCT03286465|Device|Adult phlebotomy tubes|Use of adult size tubes for diagnostic blood collection.
15947133|NCT03286452|Device|PuraPly™ Antimicrobial Wound Matrix|PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds.
15947134|NCT03286439|Other|there will be offered a follow up visit|The investigators will offer the patients a follow up visit 3 and 12 months after discharge from the hospital.
15947135|NCT03286426|Diagnostic Test|Vision/Eye screening|The back of each eye will be imaged with Pictor. Visual acuity and color vision will be checked if patient able to cooperate with exam.
15947235|NCT03285542|Device|DERMABOND|DERMABOND PRINEO (Ethicon, Johnson and Johnson, Somerville, New Jersey)
15947137|NCT03286400|Device|CTAG Device with ACTIVE CONTROL|Intent to treat with the CTAG Device with ACTIVE CONTROL in the treatment of aortic diseases as part of routine clinical practice.
15947138|NCT03286387|Other|Functional brain imaging without any contrast agent|"During the fMRI protocol, the subject will perform the retrieval tasks while whole-brain activity will be recorded using Echo Planar Imaging (EPI) that measures the Blood Oxygen Level Dependent (BOLD) signal (2x2x2 isotropic voxels, Echo Time (TE) = 30 ms, Repetition Time (TR) = 2.5 sec). The functional session will be subdivided into several parts (Runs, duration: 10-15 min). Together with the functional data, the protocol will include a structural scan (T1 weighted, 1x1x1 mm voxels; duration 5-7 min) and a field mapping sequence (duration: 1 min)."
15947139|NCT03286374|Behavioral|Occupational rehabilitation|"The participants in the occupational rehabilitation program get both practical and theoretical intervention in groups. Four main interventions; cognitive therapy, physical activity, diets and training in work-oriented approach. The rehabilitation stay is as followed:
~Four weeks with an institutional stay at Muritunet (BL)
~Follow-up;
~Eight weeks, telephone contact between therapist at Muritunet and the participant.
~16 weeks, video conference on SKYPE between all the participants and a therapist. Lecture on diets.
~28 weeks, Follow-up at Muritunet. Central themes that day is education, conversation, physical test, and forms. (T1)
~40 weeks, telephone contact between therapist at Muritunet and the participant.
~52 weeks, Follow-up at Muritunet. Central themes that day is education, conversation, physical test, and forms. (T2)"
15947140|NCT03286361|Device|BeGraft Peripheral Plus Stent Graft System|Patients will be treated with the BeGraft Peripheral Plus Stent Graft System
15947141|NCT03286335|Radiation|Proton Radiation|Radiation treatment
15947142|NCT03286322|Other|manuel therapy cervical spine|the manuel therapy in physiotherapy is focused on the cervival spine
15947143|NCT03286322|Other|control group|the manuel therapy in physiotherapy is classic and not focused on the cervival spine
15947144|NCT03286309|Device|soft robot hand system|subjects will wear the soft robot hand system and receive 60 minutes (including preparation time) hand exercise.
15947145|NCT03286296|Biological|LZM009,recombinant humanized anti-PD-1 monoclonal antibody for injection|LZM009 doses of 1, 3, and 10 mg/kg will be administrated intravenously on day 1 and 29 and every 3 weeks thereafter until disease progression or intolerable toxicity, withdrawal of consent, or end of study
15947146|NCT03286283|Device|J-Plasma|Dermal resurfacing procedure with J-Plasma.
15947147|NCT03286257|Behavioral|Exercise Intervention|A partially supervised 16-week moderate intensity exercise intervention consisting of 3-5 sessions per week.
15947148|NCT03286244|Drug|CM082 plus paclitaxel|"CM082 treatment: A treatment cycle is defined as 28 days. Oral CM082 tablets was given once daily for 3 weeks followed by 1-week break with escalating dose (100 mg, 150 mg and 200mg).
~Drug: Paclitaxel Paclitaxel 80 mg/m2 will be administrated by intravenous injection on days 1, 8, 15 of a 28-day cycle for no more than 6 cycles."
15947149|NCT03286231|Diagnostic Test|CT imaging|Contrast-enhanced CT imaging of the pelvis in prone and jackknife positions
15947150|NCT03286218|Drug|Lasmiditan|Administered orally
15947151|NCT03286218|Drug|Alprazolam|Administered orally
15947152|NCT03286218|Drug|Placebo|Administered orally
15947153|NCT03286205|Drug|IV iron|IV iron infusion based on weekly or every 3 week dosage.
15947154|NCT03286192|Behavioral|compassion cultivation training|Eight 2-hour group sessions that provide a structured and systematic way of cultivating daily-life skills needed to strengthen qualities of compassion, empathy, and kindness for oneself and others.
15947155|NCT03286179|Other|modified HEART score and/or Emergency Department Assessment of Chest pain Risk Score (EDACS)|Provision of estimated risk for major cardiac events at 60 days based on the modified HEART and/or EDACS, using KPNC specific estimates derived from an internal validation study
15947156|NCT03286153|Other|Ideal Body Weight First|Randomized to receive 50 U/kg (+/- 20%) of the factor product participants routinely use based on ideal body weight. For participants age 12-19, ideal weight is calculated using the McLaren method. For participants age 20 and over, ideal weight is calculated using the following equation: [50kg + (2.3kg*every inch over 5 feet)].
15947157|NCT03286153|Other|Actual Body Weight First|Randomized to receive 50 U/kg (+/- 20%) of the factor product participants routinely use based on actual body weight.
15947158|NCT03286140|Procedure|Early endovenous ablation|
15947159|NCT03286140|Procedure|Delayed endovenous intervention|
15947160|NCT03286127|Other|specialized palliative care|specialized palliative care provided in different settings
15947161|NCT03286114|Drug|Pembrolizumab|200mg IV every 21 days
15947162|NCT03286101|Drug|0.5% Ivermectin lotion|The intervention is composed of a single application of the 0.5% ivermectin lotion.
15947163|NCT03286101|Drug|Vehicle|The intervention is composed of a single application of the vehicle control.
15947167|NCT03286075|Device|tDCS Anode session|"The aim of this unique anode tDCS session is to study the possibility of enhancing emotional processing, attentional resources and physiological responses in healthy subjects.
~The arm will be compared to the other 2, enabling us to compare different tDCS stimulation modes.
~Stimulation will be performed using a tDCS stimulator (Neuroconn or Neuroelectric tDCS stimulator) with two 7×5 cm (35 cm2) sponge electrodes soaked in a saline solution (0.9% NaCl) Anode will be placed over the left dorsolateral prefrontal cortex (F3 according to the international EEG system) and cathode over the right dorsolateral prefrontal cortex (F4 according to the international EEG system)."
15947168|NCT03286075|Device|tDCS Cathode session|"The aim of this unique cathode tDCS session is to study the possibility of inhibiting or altering emotional processing, attentional resources and physiological responses in healthy subjects.
~This arm will be compared to the other 2, enabling us to compare different tDCS stimulation modes.
~Stimulation will be performed using a tDCS stimulator (Neuroconn or Neuroelectric tDCS stimulator) with two 7×5 cm (35 cm2) sponge electrodes soaked in a saline solution (0.9% NaCl) Cathode will be placed over the left dorsolateral prefrontal cortex (F3 according to the international EEG system) and anode over the right dorsolateral prefrontal cortex (F4 according to the international EEG system)."
15947236|NCT03285542|Device|Staples|staples for skin closure
15947169|NCT03286075|Device|tDCS Placebo session|"This arm will help compare the effects of stimulation versus no stimulation on emotional processing, attentional resources and physiological responses.
~Stimulation will be performed using a tDCS stimulator (Neuroconn or Neuroelectric tDCS stimulator) with two 7×5 cm (35 cm2) sponge electrodes soaked in a saline solution (0.9% NaCl) Anode will be placed over the left dorsolateral prefrontal cortex (F3 according to the international EEG system) and cathode over the right dorsolateral prefrontal cortex (F4 according to the international EEG system)"
15947170|NCT03286062|Combination Product|Agent VM110 and laproscopic infra-red probe|Patients with evidence of persistent or recurrent ovarian/ pancreatic cancer would be injected with escalating dose of VM110 24 hr prior to laproscopic surgery to collect biopsy sample in white light and by visualizing the cancerous mass using the laproscopic infra red probe
15947171|NCT03286036|Other|biomarkers|This is an observational study, there is no intervention
15947172|NCT03286023|Radiation|stereotactic radiotherapy|stereotactic radiotherapy for brain metastases
15947173|NCT03286010|Behavioral|Women@Heart Program|The Women@Heart program is taught by trained peer leaders. Session content is focused on: emotional support (sharing your story, road to recovery, exploration of feelings, coping with changes, emotional management, coping with distress, effective communication, empowerment); informational support (self care behaviours, risk factor education and management, health care system and community resource navigation); and appraisal support (goal setting, action planning, problem solving, relapse prevention). In total there are 12-biweekly sessions offered over a 24-week period.
15947174|NCT03285997|Biological|GC3110A|A single 0.5mL dose intramuscular injection
15947175|NCT03285997|Biological|GCFLU Pre-filled syringe inj.|A single 0.25mL dose intramuscular injection
15947176|NCT03285984|Other|67% Sodium Bicarbonate with 6 herbs plus 923parts per million (ppm) Sodium Fluoride|Toothpaste containing 67 percent (%) Sodium Bicarbonate with 6 herbs plus 923parts per million (ppm) Sodium Fluoride
15947177|NCT03285984|Other|67% Sodium Bicarbonate without herbs plus 923 ppm Sodium Fluoride|Toothpaste containing 67% Sodium Bicarbonate without herbs plus 923 ppm Sodium Fluoride
15947178|NCT03285984|Other|62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923 ppm Sodium|Whitening Toothpaste containing 62% Sodium Bicarbonate with 6 herbs and 5% w/w silica plus 923 ppm Sodium
15947179|NCT03285984|Other|0% Sodium Bicarbonate without herbs plus 923ppm Sodium Fluoride|Toothpaste containing 0% Sodium Bicarbonate without herbs plus 923ppm Sodium Fluoride
15947180|NCT03285971|Other|Electronic CPP pager alert|Anesthesia providers will receive a pager alert when CPP decreases beow 60 mmHG (median value over 5-minute epochs)
15947181|NCT03285958|Behavioral|STEPS Intervention|Participants in the STEPS (Seniors Tracking Exercise for Pain Self-management) intervention will receive a commercially-available, wearable physical activity monitor. They will be asked to wear this monitor during waking hours for 6 weeks, reporting their daily step count every evening. The way in which participants report steps will change every 2 weeks. For the first 4 weeks of the study, participants will report via Interactive Voice Response (IVR) calls for 2 weeks and SMS text messages for 2 weeks. For the final two week period, research staff will help participants to set up the monitor to automatically send daily step counts to STEPS project staff. This can be done through a smartphone, tablet, or computer.
15947182|NCT03285945|Drug|PET3|Prednisolone 60 mg daily for 3 days
15947183|NCT03285945|Drug|PET10|Prednisolone 60 mg daily for 10 days
15947184|NCT03285932|Radiation|post-operative stereotactic radiosurgery (SRS)|"For radiosurgery, patients will be immobilized. Treatment planning including the MRI and planning CT should be performed 1 -2 weeks before SRT and treatment finished at latest 3-4 weeks after surgery. Planning should be as close to SRT as possible.
~Organs at risk such as the brain stem, optic nerves, chiasm and spinal cord will be contoured. The Clinical Target Volume 1 (CTV1) will be defined as the resection cavity based on MRI and CT including T1 contrast enhanced changes around the resection cavity. The Clinical Target Volume 2 (CTV2) will be defined as a 3mm margin added to CTV1 by isotropic expansion and slightly adjusted as deemed appropriated by the experienced contouring physician. The Planning Target Volume (PTV) will be an additional margin of 1mm added to CTV2 by isotropic expansion.
~Treatment planning will be performed using Accuray's Multiplan or subsequent approved treatment planning systems for Cyberknife."
15947185|NCT03285932|Radiation|Whole brain radiotherapy (WBRT)|"For WBRT, an individual head fixation mask is manufactured for each patient, and treatment planning is performed as virtual simulation or 3D-conformal RT planning based on CT-imaging. The portals include the whole brain with special focus as including the skull base areas and lamina cribrosa. For low infratentorial lesions, the treatment volume may include the whole brain down to the second cervical vertbra.
~RT will be applied with two portals (e.g. 87°and 273°) using a 6 MeV linear accelerator.
~For WBRT, a total dose of 30 Gy in 3 Gy fractions will be applied."
15947186|NCT03285919|Device|Balance Assessment Robot (BAR™)|"The BAR™ has got six degrees of freedom (DOF) that interface to the pelvis of a walking subject. Five DOFs (translation of pelvis in sagittal, lateral and vertical directions; pelvic rotation and pelvic list) are actuated and admittance-controlled, providing transparent haptic interaction with negligible power transfer; the remaining DOF (pelvic tilt) is passive. The BAR™ is capable of delivering perturbations in the directions forward/backward and left/right, but for the purpose of this study only outward perturbations in the frontal plane were considered."
15947187|NCT03285906|Drug|Apatinib|Targeted therapy Apatinib：500 mg，po，qd
15947188|NCT03285893|Other|oral cell DNA adducts|oral cells will be collected, DNA isolated, and analyzed for adducts
15947189|NCT03285880|Behavioral|Napping|Children nap during the nap opportunity
15947190|NCT03285867|Procedure|TACE|transcatheter arterial chemoembolization
15947191|NCT03285854|Diagnostic Test|Collection of blood, urine and stool samples|Collection of blood, urine and stool samples, diet diary and bone scans
15947192|NCT03285841|Device|OCT-AFI|Both groups will be imaged with the OCT-AFI device. Imaging will not influence standard of care biospies, treatment and procedures.
15947237|NCT03285529|Device|STRATIFIX|STRATIFIX symmetric PDS Plus; Stratifix knotless suture
15947238|NCT03285529|Device|VICRYL|Vicryl #1
15947298|NCT03285009|Other|Training intervention|"Based on the baseline screening, which is part of the normal prevention routine within the school, all athletes are given individual advice with regard to points of attention within training. For example: those athletes with reduced balance, will get more balance training.
~Intervention is individual as said and will be guided and supervised by the physical trainer and medical staff of the school."
15947193|NCT03285828|Behavioral|motivationnal interviewing training|"The students received three four-hour sessions of basic motivationnal interviewing training :
~Viewing and commenting on video clips illustrating motivational and non-motivational doctor-patient interactions.
~Lectures and the distribution of memory aids.
~Practical exercises: making reflections, asking open questions; exploring ambivalence; dealing with resistance; expressing empathy, summarising.
~Role-playing, based on several situations, each involving two students. The investigators deliberately chose a non-medical situation (conflict between a mother and a student asking her for pocket money to go out for fun, the day before a university examination) for the first situation. All the other situations concerned changes to healthier behaviour in a medical setting, but with a goal different from that used for the first or the second simulated interview before motivationnal interviewing training."
15947194|NCT03285815|Device|Proton Therapy|
15947195|NCT03285802|Drug|Letrozole|Letrozole 2.5mg will be taken daily q 30 days
15947196|NCT03285802|Drug|Everolimus|Everolimus 10mg daily q 28 days
15947197|NCT03285789|Other|Passing tests in dyslexics with reduced eva|"Visual attention span : the subject see a 5 letters strings during 200 ms and he has to report it orally whatever the order Visual search : the subject has to find a target among distractors (24 or 48) in different conditions of stimuli (conjunction feature or separable feature) and different conditions of view (full view or reduced view with the moving window paradigm) Elementary visuo spatial perception: the subject passes 6 visuo spatial tests to judge his visuo spatial abilities.
~All of these tests will be made during an unique visit of 1h30."
15947198|NCT03285789|Other|Passing tests in controls|"Visual attention span : the subject see a 5 letters strings during 200 ms and he has to report it verbally whatever the order Visual search : the subject has to find a target among distractors (24 or 48) in different conditions of stimuli (conjunction feature or separable feature) and different conditions of view (full view or reduced view with the moving window paradigm) Elementary visuo spatial perception: the subject passes 6 visuo spatial test to judge his visuo spatial abilities.
~test de l'alouette : reading test during 3 minutes, we note the number of word read and the errors. We obtain lexical age.
~All of these tests will be made during an unique visit of 1h30."
15947199|NCT03285763|Drug|Atezolizumab|Participants will receive 1200 milligrams (mg) of atezolizumab administered by intravenous infusion on Day 1 of every 3-week cycle until Investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first).
15947200|NCT03285737|Dietary Supplement|Whey|Supplement provided twice daily in 30g doses
15947201|NCT03285737|Dietary Supplement|Collagen|Supplement provided twice daily in 30g doses
15947202|NCT03285724|Device|Harpoon Artificial ePTFE Chords|The Harpoon Medical Transapical device is intended to be used to reduce the degree of degenerative mitral regurgitation by delivering and anchoring one or more ePTFE cords to the affected mitral valve leaflet(s) via a small left thoracotomy on the beating heart in patients with anterior, bi-leaflet or posterior prolapse.
15947203|NCT03285711|Drug|Filgotinib|200 mg tablet administered orally once daily
15947204|NCT03285711|Drug|Lanraplenib|30 mg tablet administered orally once daily
15947205|NCT03285711|Drug|Filgotinib placebo|Tablet administered orally once daily
15947206|NCT03285711|Drug|Lanraplenib placebo|Tablet administered orally once daily
15947207|NCT03285698|Device|DermACELL®|DermACELL® is a bilayer wound matrix made out of human tissue and is applied to the wound in standard of care fashion.
15947208|NCT03285698|Device|Integra®|Integra® is a bilayer wound matrix made out of bovine tissue and is applied to the wound in standard of care fashion.
15947209|NCT03285685|Device|active tDCS|Duration: 20 minutes; Intensity: 2 mA; Placement: anodal over left M1 and cathodal over supraorbital contralateral area
15947210|NCT03285685|Device|active tDCS|Duration: 20 minutes; Intensity: 2 mA; Placement: anodal over left DLPFC and cathodal over supraorbital contralateral area.
15947211|NCT03285685|Device|sham tDCS|The procedure is the same as for active tDCS anodal over left M1 and cathodal over supraorbital contralateral area, but the in the placebo tDCS the stimulation is non-active / sham.
15947212|NCT03285672|Drug|FP-101|Dose 1
15947213|NCT03285672|Drug|Placebo Comparator|Dose 1
15947214|NCT03285659|Other|Intervention: INDI Implementation|Implementation of a collaborative care model in the context of primary care to manage depression
15947215|NCT03285646|Drug|Fasinumab|Subcutaneous (SC) every 4 weeks (Q4W)
15947216|NCT03285646|Drug|Placebo|Subcutaneous (SC) every 4 weeks (Q4W)
15947217|NCT03285633|Behavioral|Cognitive Behavioral Mutli-Symptom management(CBT)|Learn to manage distress, fatigue, and/or pain via (Cognitive Behavioral Multi-Symptom management (CBT) four one hour sessions.
15947218|NCT03285620|Drug|AL-034|Participants will receive single oral dose of AL-034 under fed or fasted conditions in part 1 and part 2
15947219|NCT03285620|Drug|Placebo|Participants will receive single oral dose of matching placebo (oral solution) under fed or fasted conditions in part 1 and part 2.
15947220|NCT03285607|Biological|MCS110|-MCS110 is an IgG1/κ humanized monoclonal antibody directed against human macrophage colony stimulating factor
15947221|NCT03285607|Drug|Doxorubicin|-Standard of care
15947222|NCT03285607|Drug|Cyclophosphamide|-Standard of care
15947223|NCT03285607|Drug|Paclitaxel|-Standard of care
15947224|NCT03285607|Procedure|Bone marrow aspirate|-Time of enrollment and at time of surgery
15947225|NCT03285607|Procedure|Peripheral blood samples|-Time of enrollment and at time of surgery
15947226|NCT03285607|Procedure|Tumor tissue|-Time of enrollment and at time of surgery
15947227|NCT03285594|Drug|Sotagliflozin|"Pharmaceutical form: Tablet
~Route of administration: Oral"
15947228|NCT03285594|Drug|Insulin glargine (HOE901)|"Pharmaceutical form: Solution
~Route of administration: Subcutaneous"
15947229|NCT03285594|Drug|Placebo|"Pharmaceutical form: Tablet
~Route of administration: Oral"
15947230|NCT03285594|Drug|Oral Antidiabetes Drugs (OADs)|OADs (including metformin) as prescribed by the investigator as per local labeling.
15947231|NCT03285581|Device|arm-1|Subject(s) will receive 2 RF treatments
15947232|NCT03285568|Drug|Palbociclib|Observe patients receiving palbociclib for dose adjustment and lab monitoring
15947233|NCT03285555|Device|STRATIFIX|STRATIFIX symmetric PDS Plus; Stratifix knotless suture
15947234|NCT03285555|Device|VICRYL|Vicryl #1
15947239|NCT03285516|Behavioral|Safety Aid Reduction Treatment|START includes many of the key elements found in empirically supported treatments for emotional disorders including a) psychoeducation regarding the nature of distress and b) exposure to internal sensations and external situations that are connected to one's distress response via identification and reduction in safety aids. Safety aids discussed in the current protocol include cognitive avoidance, situational avoidance, checking behaviors, reassurance seeking, avoidance of bodily sensations, companions, and use of alcohol and other substances.
15947240|NCT03285503|Drug|Aripiprazole IM Depot|administration of Aripiprazole IM Depot formulation at doses of 400 mg for 5 times in patients with schizophrenia.
15947241|NCT03285490|Drug|KX2-391 Ointment 1%|Dose: 1% (250 mg single-use packets); Dosage form: Ointment; Route of administration: Topical
15947242|NCT03285490|Drug|Placebo|Dosage form: Ointment; Route of administration: Topical
15947243|NCT03285477|Drug|Placebo|Vehicle Ointment was used in participants with Clinically typical AK on the face or scalp.
15947244|NCT03285477|Drug|KX2-391 Ointment 1%|The experimental drug, KX2-391 Ointment 1% was used in participants with Clinically typical AK on the face or scalp.
15947245|NCT03285464|Other|Triplanar Rotary Resistance|Trunk group will strengthen the hip using the trunk as a lever to access the hip. The hip group will use femur as the lever to strengthen the hip.
15947246|NCT03285451|Diagnostic Test|submental ultrasonography|Submental ultrasound, the noninvasive and convenient tool, has been widely applied to measure the tongue base thickness in patients with obstructive sleep apnea, so as to predict the severity and relationship with upper airway collapse.
15947247|NCT03285438|Drug|Reduced dose of DOAC|The patient will receive apixaban 2.5 mg twice daily or rivaroxaban 10 mg once daily during a mean follow-up period of 24 months (12 to 48 months)
15947248|NCT03285438|Drug|Full dose of DOAC|The patient will receive apixaban 5 mg twice daily or Rivaroxaban 20 mg once daily during a mean follow-up period of 24 months (12 to 48 months)
15947249|NCT03285425|Other|Natural history|Parent interview
15947252|NCT03285386|Behavioral|Priming exercise|"All participants will perform a bout of high-intensity priming exercise for 6 minutes, 10 minutes prior to undertaking an exhaustive exercise test on four separate occasions."
15947253|NCT03285386|Behavioral|Control Exercise|All participants will perform 3 minutes of baseline cycling prior to undertaking an exhaustive exercise test on four separate occasions.
15947254|NCT03285373|Drug|NOAC|New Oral Anticoagulant
15947255|NCT03285360|Combination Product|Sylc|a dry powder (calcium sodium phosphosilicate), based on NovaMin powder. Bottle of small and coarse particles will be used for the treatment
15947256|NCT03285360|Combination Product|fluoride varnish (Bifluorid 10)|It is a rapid- drying suspension of equal amounts of sodium fluoride and calcium fluoride.
15947257|NCT03285347|Device|Computer-based cognitive training|Computer-based cognitive programmes are computer programmes designed as games with the aim of training patients in certain cognitive domains.
15947258|NCT03285334|Device|XP-endo Shaper|mechanical preparation in a 3D manner using Xp-endo Shaper
15947259|NCT03285334|Device|iRace files|rotary mechanical preparation
15947260|NCT03285321|Drug|Nivolumab|480mg
15947261|NCT03285321|Drug|Nivolumab|3mg/kg
15947262|NCT03285321|Drug|Ipilimumab|1mg/kg
15947263|NCT03285308|Drug|Placebo|Placebo injected subcutaneously twice daily.
15947264|NCT03285308|Drug|Relamorelin|Relamorelin 10 micrograms (μg) injected subcutaneously twice daily.
15947265|NCT03285295|Device|Alinity s HBsAg and Alinity s HBsAg Confirmatory Assay|For all donor specimens with investigational Alinity s HBsAg and Alinity s HBsAg Confirmatory results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.
15947266|NCT03285295|Device|Alinity s HTLV I/II Assay|For all donor specimens with investigational Alinity s HTLV I/II results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.
15947267|NCT03285295|Device|Alinity s Anti-HCV Assay|For all donor specimens with investigational Alinity s Anti-HCV results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.
15947268|NCT03285295|Device|Alinity s HIV Ag/Ab Combo Assay|For all donor specimens with investigational Alinity s HIV Ag/Ab Combo results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.
15947269|NCT03285295|Device|Alinity s Anti-HBc Assay|For all donor specimens with investigational Alinity s Anti-HBc results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.
15947270|NCT03285295|Device|Alinity s Chagas Assay|For all donor specimens with investigational Alinity s Chagas results that are discordant with final status after supplemental testing, an attempt will be made to obtain a follow-up whole blood specimen approximately 4 to 6 weeks after initial donation for further analysis.
15947271|NCT03285282|Procedure|Thoracolumber interfascial plane block|Thoracolumber interfascial plane block versus placebo
15947272|NCT03285269|Diagnostic Test|Ultrasound Protocol|Ultrasound of the inferior vena cava, heart and lungs.
15947273|NCT03285269|Device|Bioreactance|Bioreactance assessment using Cheetah Bioreactance Device (FDA Approved). Bioreactance is a non-invasive measure of cardiac output.
15947274|NCT03285269|Procedure|Passive Leg Raise|A passive leg raise involves placing the patient supine and raising the legs to simulate an intravenous fluid bolus.
15947299|NCT03284996|Device|Doppler ultrasonography|Examination of the whole cases & controls by doppler ultrasound to measure renal resistive index.
15947303|NCT03284957|Drug|Alpelisib|"Pharmaceutical form: tablet
~Route of administration: oral"
15947304|NCT03284957|Drug|Everolimus|Pharmaceutical form: tablet
15947275|NCT03285256|Behavioral|Experimental memory training|The experimental memory training will be implemented as a computer program that uses state-of-the-art immersive technology to simulate prospective memory in everyday life in which one must remember to carry out tasks throughout the day, while engaging in current ongoing activity. Participants are asked to imagine they have a work-at-home job (ongoing activity), which is an independent program (CogMed QM) designed to train working memory, but that they also need to remember to carry out a number of tasks throughout the day. Using a touch screen, participants will need to touch objects in the simulated environment to appropriately interact with these stimuli according to their pre-assigned tasks.
15947276|NCT03285256|Behavioral|Comparator memory training 1|The first comparator memory training intervention will utilize the same overall structure and immersive computer environment as the experimental memory intervention, but will not challenge the same aspects of cognition.
15947277|NCT03285256|Behavioral|Comparator memory training 2|The second comparator memory training intervention will utilize the same overall structure and immersive computer environment as the experimental memory intervention, but will not challenge the same aspects of cognition.
15947278|NCT03285243|Device|Monochromatic blue light|Exposure to monochromatic light for the first 30 minutes in the recovery period after anesthesia to assess incidence of emergence delirium as noted by the PAED scale
15947279|NCT03285217|Dietary Supplement|Ensure Plus Advance|Supplements, labeled only with the name of the participant and his/her identification number, will be provided to the participants in the Translational Research Unit of the Miguel Servet Hospital. Every 2 weeks, changes in body composition, in particular in fat and muscle, will be assessed by bioelectrical impedance analysis (BIA). Likewise they will be asked about compliance and their diets will be controlled by a nutritionist. Fresh stool samples, urine and blood will be collected pre- and post treatment. An extensive bloodwork will be performed at the Clinical Biochemistry Service at the Miguel Servet Hospital (plasma HMB, total cholesterol, triglycerides, LDL&HDL-cholesterol, free fatty acids, glucose, insulin, β-hydroxybutyrate, hs-CRP, and liver transaminases (AST, ALT, GGT).
15947280|NCT03285217|Dietary Supplement|Ensure High Protein|Supplements, labeled only with the name of the participant and his/her identification number, will be provided to the participants in the Translational Research Unit of the Miguel Servet Hospital. Every 2 weeks, changes in body composition, in particular in fat and muscle, will be assessed by bioelectrical impedance analysis (BIA). Likewise they will be asked about compliance and their diets will be controlled by a nutritionist. Fresh stool samples, urine and blood will be collected pre- and post treatment. An extensive bloodwork will be performed at the Clinical Biochemistry Service at the Miguel Servet Hospital (plasma HMB, total cholesterol, triglycerides, LDL&HDL-cholesterol, free fatty acids, glucose, insulin, β-hydroxybutyrate, hs-CRP, and liver transaminases (AST, ALT, GGT).
15947281|NCT03285191|Other|Numerical rating scale|Following the concept elicitation interview, participants will be presented with a list of typical RA symptoms and asked to rank how bothersome each symptom is and how important it would be to improve with treatment on a 1-5 numerical rating scale (NRS).
15947282|NCT03285191|Other|Real-time data capture app|Real time data capture app is a smart-phone or web-based application which will allow the subjects to provide responses about their experience of HOA in real-time via varying video, audio, photographic and text forms using a study-specific application on their own smart device. Up to ten of the thirty interview participants can participate in the app sub study, which is voluntary.
15947283|NCT03285178|Drug|IW-1701|Oral Tablet
15947284|NCT03285178|Drug|Placebo|Oral Tablet
15947285|NCT03285165|Drug|0.2-0.7 mcg/kg/h dexmedetomedine infusion.|patients will receive dexmedetomidine 0.2-0.7 mcg/kg/h infusion for 24h.
15947286|NCT03285165|Drug|10-70 mcg/kg/h propofol infusion.|Patients will receive 10-70 mcg/kg/h propofol infusion for 24h.
15947287|NCT03285152|Other|Ketogenic Diet (KD)|specially-formulated very low carbohydrate meals (KD)
15947288|NCT03285152|Other|Standard Diet (SD)|counseling on maintaining adequate nutritional intake from a normal diet (SD)
15947289|NCT03285139|Behavioral|Cognitive Behavioural Therapy|Cognitive Behavioral Therapy 9 weekly 2-hour group CBT sessions delivered by trained lay peers.
15947290|NCT03285113|Device|GiMer Medical MN 1000 External Stimulator|Trial stimulator to generate pulsed ultrahigh frequency (>200KHz) electrical stimulation, delivered via lead around DRG, in treating pain. Similar with current market available Spinal Cord Stimulators but with a higher stimulation frequency (hundred KHz) range.
15947291|NCT03285100|Diagnostic Test|Venipuncture|"Approximately 6 months after discontinuation of VKAs one additional venipuncture will be performed for determination of dp-ucMGP and desmosine.
~At baseline two additional blood collection tubes will be drawn for determination of dp-ucMGP, desmosine and VKORC1 polymorphisms. Since this is during one of the last regular International Normalized Ratio (INR) testing at the anticoagulation clinic, no additional venipuncture has to be performed at this moment."
15947292|NCT03285087|Drug|DEX 0.2 μg/kg/h.|DEX 0.2 μg/kg/h. The dose will be increased in 0.1 μg/kg/h increments to achieve target Richmond Agitation Sedation Scale (RASS) levels of -2 to zero and with a maximum dose of 1.4 μg/kg/h for 24 hours.
15947293|NCT03285074|Other|No intervention|No intervention
15947294|NCT03285061|Device|Deterra Drug Deactivation System|A portable bag that will neutralize and dissolve excess medication, rendering it completely unusable and safe for landfill disposal. The system meets FDA and DEA standards for at home disposal systems.
15947295|NCT03285048|Behavioral|Cognitive Remediation Therapy|Brain HQ is a computer based cognitive training that uses hierarchical adaptive technology to provide challenging and demanding training that is not too frustrating or discouraging. Training includes auditory and visual sensory training, memory and executive function exercises. The Bridging group is based on similar training programs that focus on self-regulation training, problem focused cognitive behavior therapy and compensatory cognitive strategies.
15947296|NCT03285035|Device|Administration of questionaires to patients receiving an upper endoscopy with cryotherapy in addition to chemotherapy for esophageal cancer palliation.|Upper endoscopy with cryotherapy using liquid nitrogen.
15947297|NCT03285022|Procedure|Partial caries removel techniques|Removel of all superfacial dentin and leaving the inner affectted dentin
15947300|NCT03284983|Other|Suture spacing for wound closure|The wound was divided in half and sutures were spaced 5mm or 10mm apart depending on side. The sutures were removed at 2-week follow-up appointment and photographs were taken. The Patient and Observer Scar Assessment Scale (POSAS) was then performed by both patient and physician.
15947306|NCT03284944|Device|Small-Volume|"Small-volume (2 - 3 mL soft-draw Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes."
15947307|NCT03284944|Device|Standard-Volume|Standard-volume (4 - 6 mL Vacutainer tubes, Beckton Dickinson) ethylenediaminetetraacetic acid (EDTA), lithium-heparin, citrate, fluoride and silica tubes.
15947308|NCT03284931|Drug|SAGE-217 high dose|high dose
15947309|NCT03284931|Drug|Placebo|placebo
15947310|NCT03284931|Drug|SAGE-217 low dose|low dose
15947311|NCT03284918|Dietary Supplement|Plant stanol ester|
15947312|NCT03284918|Dietary Supplement|Placebo|
15947313|NCT03284905|Dietary Supplement|Probiotic supplement|Capsule containing freeze dried probiotic bacteria together with maize starch
15947314|NCT03284905|Dietary Supplement|Placebo supplement|Capsule containing maize starch
15947315|NCT03284892|Behavioral|PED care|A once daily, 7-day PED Care intervention on reducing time to resume oral intake, rates of penetration and intervention at 10 days postextubation, and incidences of 30-day aspiration pneumonia in adult patients with prolonged intubation (≥48 hours)
15947316|NCT03284892|Diagnostic Test|FEES test|Using FEES to see if participants have any aspiration or penetration and the level of it.
15947317|NCT03284892|Other|usual care|usual care means the original care given by the ward the participants stay.
15947318|NCT03284866|Other|Laboratory Biomarker Analysis|Correlative studies
15947319|NCT03284866|Biological|Recombinant Human Papillomavirus Nonavalent Vaccine|Given IM
15947320|NCT03284866|Other|Saline|Given IM
15947321|NCT03284853|Drug|Netarsudil/Latanoprost 0.02%/0.005%|Topical sterile ophthalmic solution
15947322|NCT03284853|Drug|GANFORT®|Topical sterile ophthalmic solution
15947323|NCT03284840|Diagnostic Test|Assessement of nutritional status|Nutritional status for vitamin D, folic acid, vitamin B12 and iron.
15947324|NCT03284840|Diagnostic Test|Thyroid size|Thyroid size by ultrasound.
15947327|NCT03284814|Dietary Supplement|Single dose intervention with Standard product (SP)|hard capsules, 100 mg
15947328|NCT03284814|Dietary Supplement|Single dose intervention with Comparative product (CP)|soft-gel capsules, 100 mg
15947329|NCT03284814|Dietary Supplement|Single dose intervention with Investigational product (IP)|syrup, 100 mg
15947330|NCT03284814|Dietary Supplement|Multiple dose intervention with Standard product (SP)|hard capsules, 100 mg - 14 days
15947331|NCT03284814|Dietary Supplement|Multiple dose intervention with Comparative product (CP)|soft-gel capsules, 100 mg - 14 days
15947332|NCT03284814|Dietary Supplement|Multiple dose intervention with Investigational product (IP)|syrup, 100 mg - 14 days
15947333|NCT03284801|Other|management of acute disseminating encephalomyelitis|clinical audit on management of acute disseminating encephalomyelitis
15947334|NCT03284788|Behavioral|ABT Weight Loss Intervention|This includes 15 sessions that are each 90 minutes in length. Intervention sessions will be weekly for the first 2 months, bi-weekly for the next 2 months, and monthly for the last 2 months.
15947335|NCT03284775|Device|Intraoperative ultrasound|Patients will undergo transsphenoidal surgery in the usual manner except that an intraoperative ultrasound device will be available for use to better visualise the tumour and surrounding neurovascular structures.
15947336|NCT03284762|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Rivaroxaban is a direct Factor Xa inhibitor. In this non-interventional setting, the prescription and dosing scheme is up to the treatment physician, however, the recommended dosing scheme is 20mg/day (once daily) or 15 mg/day (once daily) in patients with reduced renal function
15947337|NCT03284749|Other|Copper impregnated wound dressing|Copper impregnated wound dressing
15947338|NCT03284749|Other|Normal wound dressing|Normal wound dressing
15947339|NCT03284749|Other|Copper impregnated maternity pads|Copper impregnated maternity pads
15947340|NCT03284749|Other|Normal maternity pads|Normal maternity pads
15947341|NCT03284736|Procedure|Resorbable membrane|
15947342|NCT03284736|Procedure|periapical surgery without membrane|after removing pathology and retro-filling the tooth /teeth wit MTA the defect area is left as it is and flap is closed without resorbable membrane.
15947343|NCT03284723|Drug|PF-06804103|Dose Escalation Part - 1A Dose Expansion Part - 2A
15947344|NCT03284723|Drug|PF-06804103 + Palbociclib +Letrozole|Dose Escalation - Part 1B Dose Expansion - Part 2B
15947345|NCT03284710|Biological|ALVAC-HIV (vCP2438)|Expresses the gene products ZM96 gp120 (clade C strain) linked to the sequences encoding the HIV-1 transmembrane (TM) anchor sequence of gp41 (28 amino acids clade B LAI strain) and gag and pro (clade B LAI strain); formulated as a lyophilized vaccine for injection at a viral titer ≥ 1 × 10^6 cell culture infectious dose (CCID)50 and < 1 × 10^8 CCID50 (nominal dose of 10^7 CCID50) and reconstituted with 1mL of sterile sodium chloride solution (NaCl 0.4%) for intramuscular (IM) injection as a single dose
15947346|NCT03284710|Biological|Bivalent Subtype C gp120/MF59|Consists of 2 subtype C recombinant monomeric proteins, TV1.C gp120 Env and 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant (an oil-in-water emulsion); delivered as a 0.5 mL IM injection
15947347|NCT03284710|Biological|Bivalent Subtype C gp120 admixed with Al(OH)3 Suspension|Consists of 2 subtype C recombinant monomeric proteins, TV1.C gp120 Env and 1086.C gp120 Env, each at a dose of 100 mcg, admixed with Aluminum Hydroxide Suspension (~625 mcg aluminum content); delivered as a 0.5 mL IM injection
15947348|NCT03284710|Biological|Bivalent Subtype C gp120|Consists of 2 subtype C recombinant monomeric proteins, TV1.C gp120 Env and 1086.C gp120 Env, each at a dose of 100 mcg, mixed with sodium chloride for injection, 0.9%; delivered as a 0.5 mL IM injection
15947349|NCT03284697|Procedure|Direct Pulp Capping with Ca(OH)2|Calcium hydroxide powder was mixed with saline and placed over the exposed pulp tissue. The cavities were then restored with resin modified GIC liner followed by composite restoration.
15947350|NCT03284697|Procedure|Direct Pulp Capping With MTA|MTA was mixed using1:3 water/ powder ratio and applied to exposure site. Then cotton pellets soaked in normal saline was placed over MTA and cavity was sealed provisionally with IRM. After 24 hours, the patient was recalled and the cavity was restored with resin modified GIC liner followed by composite restoration.
15982492|NCT03018210|Procedure|Surgical repair of the rotator cuff|
15947351|NCT03284684|Other|Blood test|plasma concentration of circulating DNA of specific genes
15947352|NCT03284671|Other|bifocal stimulation with tDCS|Patients will receive an active Treatment with tDCS (10 sessions of 30 mn with an intensity of 2 mA)
15947353|NCT03284645|Drug|Tenofovir Disoproxil Fumarate (TDF) 300 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mg|Fixed-dose combination of 300 mg TDF, 300 mg 3TC and 600 mg EFV taken once daily.
15947354|NCT03284645|Drug|Abacavir (ABC) 600 mg + Lamivudine (3TC) 300 mg + Efavirenz (EFV) 600 mg|Fixed-dose combination of 600 mg ABC, 300 mg 3TC and 600 mg EFV taken once daily.
15947355|NCT03284645|Drug|Zidovudine (AZT) 300 mg + Lamivudine (3TC) 150 mg twice daily + Efavirenz (EFV) 600 mg once daily|Fixed-dose combination of 300 mg AZT and 150 mg 3TC taken twice daily, plus 600 mg EFV taken once daily.
15947356|NCT03284619|Device|Magnetic resonance imager linear accelerator|The MR linear accelerator (MRL) integrates a radiotherapy accelerator and a diagnostic quality 1.5T MRI, enabling soft-tissue visualization during the actual radiation delivery for improved targeting. This enables on-line treatment optimization for precise radiation delivery. Better visualization of the tumour targets and the surrounding healthy tissues, at the exact moment of treatment, makes it possible to adapt the dose to the actual anatomy while optimally sparing normal tissues.
15947357|NCT03284606|Device|TAPING|Taping in conjunction with common rehabilitation for hemiplegic patients
15947358|NCT03284606|Procedure|Common rehabilitation|Common rehabilitation for hemiplegic patients
15947359|NCT03284593|Drug|intensive chemotherapy|
15947360|NCT03284593|Drug|Azacitidine|
15947361|NCT03284580|Other|Ergonomic intervention|An ergonomic intervention program focused to caregivers, including recommendation about how they should help themself and the patients activities at home.
15947362|NCT03284580|Other|Postural plus kinesiotherapy intervention program|An ergonomic intervention program focused to caregivers, including recommendation about how they should help themself and the patients activities at home.
15947363|NCT03284580|Other|Control or conservative intervention|A control or conservative intervention, including general information about stroke disease for the caregivers of these patients
15947364|NCT03284567|Behavioral|Football fitness|"The training will consist of 30 min of warm-up exercises (running, dribbling, passing, shooting, balance and muscle strength exercises), followed by 2 x 15 minutes of 4-7 a-side games.
~Training will take place on a natural grass pitch. In adverse weather conditions (i.e., < 5°C or heavy rain) training will be performed indoors"
15947365|NCT03284554|Dietary Supplement|Encapsulated nutrients|Amino acid + Lipid; Probiotic bacteria
15947366|NCT03284554|Dietary Supplement|Non-encapsulated nutrients|Amino acid + Lipid; Probiotic bacteria
15947367|NCT03284554|Dietary Supplement|Placebo|Nutrient not expected to stimulate release of GLP-1 and PYY
15947368|NCT03284541|Behavioral|2GETHER|Communication skills, coping skills, problem-solving, acceptance, HIV prevention
15947369|NCT03284541|Behavioral|Existing Public Health Practice|HIV testing, medication adherence, HIV risk reduction
15947370|NCT03284528|Other|hypothermia therapy|newborn infants with hypoxic-ischaemic encephalopathy are cooled for 72 hours with a target temperature of 33-34°C (whole body cooling).
15947371|NCT03284515|Biological|Vaccination with a pertussis containing vaccine|Vaccination with a pertussis containing vaccine
15947372|NCT03284502|Drug|HM95573, cobimetinib|Regimen: twice daily (BID), continuous dosing for HM95573, once daily (QD) 21 days, 7 days off for cobimetinib
15947373|NCT03284502|Drug|HM95573, cetuximab|Regimen: twice daily (BID), continuous dosing for HM95573
15947374|NCT03284502|Drug|HM95573, cobimetinib|Regimen: Recommended dose (RD) and schedule selected based on the data of safety, tolerability, pharmacokinetics, and anti-tumor activity tested in Stage 1
15947375|NCT03284502|Drug|HM95573, cetuximab|Regimen: Expansion dose of HM95573 selected based on the data of safety and tolerability tested in Stage 1b
15947376|NCT03284489|Other|Collection of medical datas from ICU patients|Collection of medical datas from ICU patients with pancreatitis on a secured electronic database
15947377|NCT03284476|Other|Collection of medical data from ICU patients|Medical data collected on a electronic secured data base
15947378|NCT03284463|Drug|Glibenclamide|Glibenclamide is administered with a loading dose of 1.25 mg within 10 hours of stroke onset, orally or through gastric tube, followed by 0.625 mg every 8 hour for 5 days.
15947379|NCT03284463|Drug|Placebo|Placebo is administered with a loading dose of 1.25 mg within 10 hours of stroke onset, orally or through gastric tube, followed by 0.625 mg every 8 hour for 5 days.
15947380|NCT03284450|Other|DPFT|The DPFT described previously (Redding et al., 2009) involves the repetition of a 'dance phrase' representative of contemporary dance, with each phrase separated by a 2 minute rest period. For the present study the originally described test was extended; the adapted protocol involved 10 x 1 minute movement phrases, each separated by 2 minutes rest.
15947381|NCT03284450|Other|SSRS|The SSRS (Howatson & Milak, 2009) involved 15 x 30 m sprints with a rapid 10 m deceleration phase, with each sprint departing every 65 seconds.
15947382|NCT03284437|Behavioral|Early Cognitive Training|Choose level of activity (e.g., coloring, holding objects) based on occupational therapist assessment.
15947383|NCT03284424|Biological|Pembrolizumab|IV infusion
15947384|NCT03284411|Device|Spinal Cord Stimulation|Programming
15947385|NCT03284385|Drug|Adavosertib|Given PO
15947386|NCT03284372|Behavioral|Text Message Only|The intervention group (n=25, randomly selected from the base cohort) will receive informational and socially supportive text messages during a 10-week intervention. Investigators will deploy the intervention using the Way to Health platform, which automates outgoing messages and feedback. Many of the messages will be sent to all Intervention 1 participants, to assure consistency of the intervention. A subset will be tailored to address participants' specific allergies. At 10 unannounced check-ins, we will send text messages asking participants in the intervention and control groups if they are carrying their epinephrine.
15947387|NCT03284372|Behavioral|Text message + Incentive 1|Among base cohort members not exposed to the text message only intervention (#1), we will randomly select a new intervention group (n=50) to receive text message reminders plus Incentive 1. At each of 10 unannounced check-ins, if unsuccessful in documenting epinephrine-carrying, participants will lose part of their incentive. The remainder of the Cohort (control) will receive text reminders.
15947461|NCT03283800|Other|Normal compression stocking|Normal compression stocking without copper
15947388|NCT03284359|Behavioral|Pre-Consent Nudge Bundle|The pre-consent nudge bundle survey was developed by the study team and incorporates several behavioral interventions into a bundle of 5 types of nudges: (i) injunctive norms; (ii) descriptive norms; (iii) duty of reciprocity; (iv) self-prophecy; and (v) foot-in-the-door. Injunctive norms involve the perception of what behavior is acceptable, while descriptive norms highlight what behaviors others are engaging in. The duty of reciprocity is the sense that one should repeat pro-social behavior for which they have benefited from. The foot-in-the-door nudge involves asking a participant to perform a small request which has a high consent rate followed by a larger request. The bundle consists of six questions and one statement.
15947389|NCT03284346|Behavioral|Exercise Intervention|Undergo CARE
15947390|NCT03284346|Behavioral|Exercise Intervention|Undergo standard stretching program
15947391|NCT03284346|Other|Laboratory Biomarker Analysis|Correlative studies
15947392|NCT03284346|Device|Monitoring Device|Receive Polar heart rate monitor
15947393|NCT03284346|Other|Quality-of-Life Assessment|Ancillary studies
15947394|NCT03284346|Other|Questionnaire Administration|Ancillary studies
15947395|NCT03284333|Device|other|no arm
15947396|NCT03284307|Drug|Dexmedetomidine|20 participants will be administered Dexmedetomidine.
15947397|NCT03284307|Drug|Ketamine|20 participants will be administered Ketamine.
15947398|NCT03284307|Drug|Propofol|20 participants will be administered Propofol.
15947399|NCT03284307|Drug|Midazolam|20 participants will be administered Midazolam.
15947400|NCT03284294|Drug|Cholecalciferol|cholecalciferol 2000 IU oral daily for 8 weeks
15947401|NCT03284294|Drug|Placebo|Oral placebo daily for 8 weeks
15947402|NCT03284281|Device|Tragus stimulator|Tragus nerve stimulation for at least 8 hours per day for 1 week post discharge.
15947403|NCT03284281|Device|Sham Tragus stimulator|No stimulation will be performed
15947404|NCT03284268|Genetic|VCN-01|VCN-01 intravitreal injection
15947405|NCT03284255|Device|study group|study group in which patient will accept the treatment of Bioresorbable Coronary Stent
15947406|NCT03284255|Device|control group|control group in which patient will accept the treatment of Drug Eluting Stent of Abbott's XIENCE PRIME™ or XIENCE V®
15947407|NCT03284242|Procedure|Apheresis|Collect white blood cells to isolate Treg cells for expansion. Once the blood cells are collected the cells will be cultured in the laboratory and will be expanded. After approximately 3 weeks in culture, the cells will have increased in number and be ready for the autologous Treg cell infusion.
15947408|NCT03284229|Device|Excimer Laser Coronary Atherectomy|Excimer Laser Coronary Atherectomy (ELCA ®) uses the high energy, monochromatic light beam to alter or dissolve (vaporize) the plaque without damaging the surrounding tissue. Fiber-optic catheters are used to deliver this light beam. For endovascular applications, Xenon Chloride excimer laser is used and its fiber-optic catheter has multiple small fibers, rather than just a few large fibers, in order to be flexible enough to navigate in the arterial tree.
15947409|NCT03284216|Procedure|Steady-state hyperglycemia|"Experimental diabetic like steady-state hyperglycemia will be induced via a continuous-rate intravenous glucose infusion."
15947410|NCT03284216|Procedure|Fluctuating hyperglycemia|"Experimental diabetic like fluctuating hyperglycemia will be induced via repeated intravenous glucose injections."
15947411|NCT03284216|Behavioral|Exercise|Moderate-intensity exercise bout (45-minutes of cycling at 70% of their heart rate max) at T=4.5 hours
15947412|NCT03284203|Device|SpiroPD|At the time of their initial study visit, study participants will be given a SpiroPD device for use at home following instruction in the hospital or clinic. Patient adherence to daily testing over one-month will be monitored using real-time capture Wi-Fi-data from the SpiroPD data portal.
15947413|NCT03284190|Procedure|Surgery|Surgery
15947414|NCT03284177|Drug|Calcium (13C)Carbonate|C13-CAC breath test containing Calcium (13C) Carbonate was performed twice under fasting conditions.
15947415|NCT03284177|Drug|Gastric acid inhibitors|Gastric acid inhibitor was orally administrated once daily for 4weeks after first C13-CAC breath test.
15947416|NCT03284177|Other|Gastric pH monitoring|Gastric pH monitoring was performed once under fasting condition.
15947417|NCT03284164|Drug|Tenofovir Exalidex (TXL)|Drug: Tenofovir Exalidex (TXL)
15947418|NCT03284151|Radiation|Cyberknife|
15947419|NCT03284138|Device|rTMS treatment|patient will be treated with 10 sessions in 5 days with low frequency (1Hz) of Repetitive Transcranial Magnetic Stimulation (rTMS)
15947420|NCT03284138|Device|placebo treatment|patient will be treated with 10 sessions in 5 days with low frequency (1Hz) of Sham-controlled
15947421|NCT03284125|Other|Swallowing disorders evaluation|Self-administered questionnaires and non-invasive clinics tests
15947422|NCT03284112|Behavioral|Old SCHOOL Hip-Hop|"A school-based intervention called Old S.C.H.O.O.L. Hip-Hop (OSHH) or Seniors Can Have Optimal aging and Ongoing Longevity, to educate 4th and 5th grade students (ages 9-11y) about key dementia signs and symptoms, basic pathophysiology of Alzheimer disease, and the importance of early recognition, care-seeking behavior, and preventative measures (lifelong healthy lifestyle decisions). The intervention is delivered in a classroom or school auditorium setting, using an innovative, modular, multimedia program and home-based activities, to increase parental and family dementia literacy."
15947423|NCT03284112|Behavioral|My Plate|"The program selected for the control arm, My Plate, will address nutrition, physical activity, and obesity education. This program was selected because nutrition, physical activity, and wellness programs are now being incorporated into New York City public school curriculums as part of a legislative directive. Trained facilitators will conduct My Plate as an entry point for the USDA's My Plate nutrition program. Students will learn about My Plate across the 3-day one-hour-a-day program."
15947424|NCT03284099|Drug|ACEi, ARB|To take the ACEis or ARBs before bedtime instead of in the morning
15947425|NCT03284086|Diagnostic Test|upper-body double-poling|An incremental peak test to exhaustion and four 5-min submaximal stages were performed in the upper-body double-poling mode.
15947426|NCT03284086|Diagnostic Test|arm crank ergometry|An incremental peak test to exhaustion and four 5-min submaximal stages were performed in the arm crank ergometry mode.
15947427|NCT03284073|Procedure|Uterus transplantation|Transplantation of the uterus from a live donor and IVF treatment
15947462|NCT03283787|Device|MicroMatrix® and Cytal™ Wound Matrix 2-Layer|MicroMatrix® and Cytal™ Wound Matrix 2-Layer
15982754|NCT03016338|Drug|Niraparib|200 or 300 mg daily PO, for 21 day cycle
15947428|NCT03284060|Behavioral|Cognitive remediation program|"Cognitive remediation program is a set of reeducation techniques and aims at restoring or compensating altered cognitive functions such as memory, attentional or executive functions, and social cognition. Therapists help individuals develop new information processing strategies designed to meet their needs and wishes. Specific therapeutic sessions are designed to generalize such strategies to everyday situations to reduce the impact of cognitive deficits on daily life. Thus, social cognitive training therapy helps the development of personal strategies specifically adapted to preserve skills and reduce the difficulties.
~16 sessions (45 min) of cognitive remediation with the therapist are proposed, each session is composed of three parts:
~pen and paper tasks focusing on specific emotion recognition component (20 min),
~computerized tasks focusing on the same process (20 min),
~a proposal of a home-based task (during 20 min)."
15947429|NCT03284047|Drug|Botulinum toxin type A|Participants will be randomized to one of three botulinum toxin type A doses.
15947430|NCT03284034|Device|CoolCurve|The right and left sides of the upper back fat will be randomly assigned to receive Cryolypolysis (CoolCurve + Advantage applicator) 35 minutes session, 3 sessions 30 days apart.
15947431|NCT03284034|Drug|ATX-101|The right and left sides of the upper back fat will be randomly assigned to receive The right and left sides of the upper back fat will be randomly assigned to receive ATX-101 (deoxycholic acid) injections, 3 sessions, 30 days apart.
15947432|NCT03284021|Device|Fractional erbium-glass 1550 nm laser|The fractional erbium-glass 1550 nm laser will be applied to the previously 100 cm2 determined area of the scalp with the following parameters: 5-10 mm tip, 5-10 mJ, pulse energy 500-1500 MTZ/cm2 density, one to twopasses, static mode.
15947433|NCT03284008|Other|Manual manoeuver + stretching|Patients in experimental group will receive, after AWS diagnose, a manual manoeuver to snap the cord, follow by a demonstration and education of the exercise to be made at home.
15947434|NCT03284008|Other|stretching exercise|Patients in control group will receive, after AWS diagnose, just a demonstration and education of the exercise to be made at home.
15947435|NCT03283995|Other|Cardiac Volume Monitoring VolumeView|hemodynamic measure
15947436|NCT03283995|Device|echocardiography|hemodynamic measure
15947437|NCT03283982|Device|Robotic Ventral Hernia Repair with IPOM|Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the da Vinci robotic platform
15947438|NCT03283982|Device|Laparoscopic Ventral Hernia Repair with IPOM|Minimally invasive ventral hernia repair with intraperitoneal mesh placement, using the laparoscopic platform
15947439|NCT03283969|Other|Freeze Dried Strawberry Powder|Study participants will be randomized to receive either the freeze dried strawberry powder or the control powder first. They will be instructed to consume 39g of the powder, mixed in water, every day for 4 weeks.
15947440|NCT03283969|Other|Isocaloric powder|Isocaloric powder
15947441|NCT03283956|Device|Patient records|Retrospective analysis of medical records of all patients who underwent DC Bead TACE at National Taiwan University Hospital, National Cheng Kung University Hospital, and Taichung Veterans General Hospital from 2010-2017/7
15947442|NCT03283943|Radiation|Focal radiotherapy|Focal sensitizing radiotherapy will be given at a starting dose level of 24 Gray (6 Gy X 4 fractions), and may be escalated to 32 Gy (8Gy X4 fractions).
15947443|NCT03283943|Drug|Durvalumab|Durvalumab 1500 mg IV every 28 days
15947444|NCT03283930|Behavioral|Active Attention Bias Modification Training|Computer-based attention bias modification training administered at weekly CBT session aimed at re-training attentional biases
15947445|NCT03283930|Behavioral|Placebo Attention Bias Modification Training|Placebo version of a computer-based attention bias modification training administered at weekly CBT session thought to not influence attentional biases
15947446|NCT03283917|Biological|Daratumumab|Given IV
15947447|NCT03283917|Drug|Dexamethasone|Given IV or PO
15947448|NCT03283917|Drug|Ixazomib|Given PO
15947449|NCT03283904|Other|Multicomponent physical activity intervention|School-based multicomponent intervention
15947450|NCT03283891|Other|Educational intervention - humanistic nursing practice|"Four educational sessions:
~Acquisition of core concepts of caring practice (I)
~Acquisition of core concepts of caring practice (II)
~Search for meaning: Influencing hope in persons through humanistic practice
~Enacting different caring attitudes and behaviours in an intermediary simulation exercise with actor"
15947451|NCT03283878|Drug|Cefazolin|"Cefazolin will be administered intravenously within less than 60 minutes prior to skin incision in elective TKA for Group 1.
~Cefazolin will be administered intravenously within less than 60 minutes prior to skin incision in elective TKA. In addition, two weight based doses of cefazolin will be administered within 24 hours postoperatively for Group 2."
15947452|NCT03283865|Diagnostic Test|Ultrasound guidance for caudal block|The attending anesthesiologist will perform or instruct the placement of a caudal block according to their standard of practice. At the time of administration of local anesthetic into the caudal space, the study collaborator (SC) will ultrasound the caudal space keeping the provider placing the block blinded to the imaging. The provider placing the block will inject 0.5mL of preservative free saline. The provider will then be asked to state if they are correctly in the caudal space or not. If the provider feels they are not in the caudal space, they will re-do the procedure. If the provider fails to identify incorrect location and this is noted by ultrasound, the SC will inform the provider to re-do the procedure
15947453|NCT03283852|Genetic|blood sample|search for genetic mutations
15947454|NCT03283839|Diagnostic Test|Posturography|Evaluation of postural control and of orientation function
15947455|NCT03283826|Biological|ATA188|ATA188 is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ progressive multiple sclerosis.
15947456|NCT03283826|Drug|Placebo|Placebo matching to ATA188
15947457|NCT03283813|Dietary Supplement|Zinc|In this active Group there will be a supplementation with Zinc (5 mg), Myo-inositol (2000 mg) and GOS (Galacto-oligosaccharides) of Pisum sativum (1000 mg)
15947458|NCT03283813|Drug|Placebos|In this placebo Group there will be a supplementation with a product placebo equal to the active product with GOS (Galacto-oligosaccharides) of Pisum sativum(1000 mg) but without Zinc and Myo-inositol.
15947459|NCT03283813|Drug|Myoinositol|In this active Group there will be a supplementation with Zinc (5 mg), Myo-inositol (2000 mg) and GOS (Galacto-oligosaccharides) of Pisum sativum (1000 mg)
15947460|NCT03283800|Other|Copper impregnated compression stocking|Copper impregnated compression stocking
15947463|NCT03283787|Device|MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT|MicroMatrix® and Cytal™ Wound Matrix 2-Layer plus NPWT
15947464|NCT03283787|Device|Negative Pressure Wound Therapy|Negative Pressure Wound Therapy
15947465|NCT03283774|Other|current clinical practice|quality management (data registration, drug prescription, diagnostic and clinical tests ...), in primary care of patients with diabetes mellitus
15947466|NCT03283761|Drug|Nab-paclitaxel 150 mg/m^2|Stage I (N=12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15
15947467|NCT03283761|Drug|Oxaliplatin 85 mg/m^2|Stage I (N= 12), on day 1 and day 15 Stage II (N= 25), on day 1 and day 15
15947468|NCT03283761|Drug|5-FU 1200 mg/m^2 x 2 D|Stage I (N= 12), on day 1 and day 15-16 Stage II (N= 25),on day 1 and day 15-16
15947469|NCT03283761|Drug|Leucovorin 400 mg/m^2|Stage I (N= 12),on day 1 and day 15 Stage II (N= 25), on day 1 and day 15
15947470|NCT03283748|Device|Wearable sensors|Wearable sensors will be given to the participants to be worn and movement data will be collected
15947471|NCT03283735|Behavioral|Elderly Enablement|The information given in this group will result from the knowledge obtained in previous phase of the study in the shape of small leaflets and other information materials to be made according to the best practice, to be given and remembered at scheduled times to the intervention group
15947472|NCT03283722|Device|Profile 3D™ and CG Future® annuloplasty system|Patients suffering from mitral valve disease and indicated for a mitral valve repair procedure with Profile 3D™ and CG Future® annuloplasty system as part of standard of care, in accordance with the product label indications (instructions for use), contraindications, and warnings
15947473|NCT03283709|Device|Full-contour monolithic zirconia abutment crowns|Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from monolithic multi-layered zirconia
15947474|NCT03283709|Device|Conventional abutment crowns|Subjects with RPD abutment teeth that require surveyed crowns will have them fabricated from noble or high noble metals, veneered with feldspathic porcelain
15947475|NCT03283696|Drug|Olaratumab|Administered IV
15947476|NCT03283696|Drug|Doxorubicin|Administered IV
15947477|NCT03283696|Drug|Ifosfamide|Administered IV
15947478|NCT03283696|Drug|Mesna|Administered per standard of care
15947479|NCT03283670|Drug|Nitrous Oxide 25%|Nitrous oxide, an odorless, colorless gas typically used as an induction agent for general anesthesia or for dental sedation, is a known N-methyl-D-aspartate (NMDA) antagonist. It will be given at a concentration of 25% nitrous oxide/50% oxygen/25% nitrogen.
15947480|NCT03283670|Drug|Nitrous Oxide 50%|Nitrous oxide, an odorless, colorless gas typically used as an induction agent for general anesthesia or for dental sedation, is a known N-methyl-D-aspartate (NMDA) antagonist. It will be given at a concentration of 50% nitrous oxide/50% oxygen.
15947481|NCT03283670|Drug|Placebo Gas|Placebo gas given at 50% nitrogen [inert]/50% oxygen.
15947482|NCT03283657|Behavioral|DiRECT|DiRECT participants will meet with a medical assistant (MA) before a routinely scheduled office and formulate a preliminary treatment plan for T2D prevention. Participants will attend their scheduled physician visit, during which they may make a definitive treatment plan to initiate metformin and/or ILI.
15947483|NCT03283657|Behavioral|Usual care (UC)|Standard care with routine medical care.
15947484|NCT03283631|Biological|EGFRvIII-CARs|Gamma-retroviral MSGV1 139 scFv EGFRvIII CAR gene-modified T cells
15947485|NCT03283618|Behavioral|Video Conferencing Group|
15947486|NCT03283605|Radiation|SBRT|SBRT to 2-5 oligometastases will be administered between Cycle 2 and 3 of durvalumab and tremelimumab. All SBRT will be completed within a 3-week period.
15947487|NCT03283605|Drug|Durvalumab|Durvalumab (1500 mg IV q4weeks) for 4 cycles in combination with tremelimumab. Then, durvalumab alone until confirmed disease progression, death, unacceptable toxicity, withdrawal of consent, or other discontinuation criteria met.
15947488|NCT03283605|Drug|Tremelimumab|Tremelimumab (75mg IV q4weeks) for 4 cycles in combination with Durvalumab.
15947489|NCT03283592|Other|Rank-Heat Plot|provides a visual presentation of treatment hierarchy across multiple outcomes
15947490|NCT03283592|Other|SUCRA Plot|provides a visual presentation of treatment ranking for a single outcome.
15947491|NCT03283566|Drug|Hydroxychloroquine|Subjects will receive a pre-transplant 200 mg daily dose of HCQ 30 days before TPAIT and will continue on the drug for 3 months after surgery.
15947492|NCT03283566|Drug|Placebo|Subjects will receive a pre-transplant placebo 30 days before TPAIT and will continue on the placebo for 3 months after surgery.
15947493|NCT03283553|Other|Checklist, MyChart, OpenNotes|1) Patient-family agenda-setting checklist, 2) Facilitated proxy registration for MyChart, and 3) Education on access to doctor's electronic visit notes.
15947494|NCT03283553|Other|Usual Care|Routine medical oncology care
15947495|NCT03283540|Procedure|TaTME|Low anterior resection of the rectum entails a sharp dissection circumferentially around the mesorectum in an avascular plane between the visceral and parietal layers of the endopelvic fascia in what is known as Total Mesorectal Excision. This dissection can be achieved transanally starting down in the pelvis and going up in what is known as Transanal Total Mesorectal Excision
15947496|NCT03283540|Procedure|TME|Low anterior resection of the rectum entails a sharp dissection circumferentially around the mesorectum in an avascular plane between the visceral and parietal layers of the endopelvic fascia in what is known as Total Mesorectal Excision. This surgery can also be done via an up-to-down approach beginning high in the abdomen and going low in the pelvis to achieve dissection around the mesorectum.
15947497|NCT03283514|Other|Complete denture|questionnaire
15947498|NCT03283501|Procedure|PCI after TAVI|Any patient undergoing PCI after TAVI, irrespective of clinical indications and irrespective of whether planned or not at the time of TAVI
15947499|NCT03283488|Drug|Mirtazapine|Tablets of 15mg mirtazapine will be used according to randomization. At the first visit, patients will be instructed to take one tablet at night for better tolerability. From the second week, if there is good tolerance, they will take two tablets at night until the end of the study.
15947500|NCT03283488|Drug|Megestrol|Tablets of 160mg megestrol will be used according to randomization. At the first visit, patients will be instructed to take one tablet at night for better tolerability. From the second week, if there is good tolerance, they will take two tablets at night until the end of the study.
15947605|NCT03282669|Drug|Intravenous hydromorphone|Intravenous hydromorphone administered via IV in the post operative area.
15947501|NCT03283475|Procedure|thigh lift|liposuction-assisted medial avulsion thighplasty enables technically refined contouring of the thigh and the possible preservation of the local microvasculature, which results in reduced complication rates
15947502|NCT03283462|Dietary Supplement|AMAZ-02|AMAZ-02 containing softgels
15947503|NCT03283462|Dietary Supplement|Placebo|Placebo containing softgels
15947504|NCT03283449|Drug|18F-AV-1451|
15947505|NCT03283449|Device|PET|PET scanner for brain imaging
15947506|NCT03283436|Drug|Bupivacaine Hydrochloride 0.25% Injection Solution|10 mL of 0.25% bupivacaine hydrochloride (2.5 mg/mL = 25 mg)
15947507|NCT03283423|Device|Image-guided Lymphadanectomy in AMIGO|Image guided laparoscopic lymph node biopsy
15947508|NCT03283410|Drug|Propofol|Propofol plasmatic concentration (Marsh)
15947509|NCT03283397|Drug|EK-12|10 mg metenkefalin acetate + 2 mg tridecactide acetate in 2 mL 0.9 % NaCl solution.
15947510|NCT03283397|Drug|INF beta-1a|Active substance is INF beta-1a, 44 mcg in 0.5 mL solution
15947511|NCT03283384|Drug|Letrozole|Letrozole 2.5 mg daily.
15947512|NCT03283384|Drug|Chemotherapy|Dose dense AC-T chemotherapy: consisting of 4 cycles of AC (doxorubicin and cyclophosphamide at a dose of 60 and 600 mg/m² as an i.v. bolus, respectively) 2-weekly, plus G-CSF (6 mg once per cycle) 24-48 hr after chemotherapy, followed by cycles of T (4 cycles docetaxel 100 mg/m² 3-weekly or 12 cycles paclitaxel 80 mg/m2 weekly).
15947513|NCT03283384|Drug|Ribociclib plus letrozole|Ribociclib 600 mg/day (days 1-21, q4 weeks) plus letrozole 2.5 mg daily (days 1-28, q4 weeks).
15947514|NCT03283371|Drug|Natalizumab|As specified in the treatment arm.
15947515|NCT03283371|Other|Placebo|As specified in treatment arms.
15947516|NCT03283358|Behavioral|Person-centered follow up|
15947517|NCT03283345|Procedure|modified radical mastectomy|systemic responses to trauma are compared with evaluating inflammatory cytokine levels between premenopausal and postmenopausal patient groups with different estrogen levels who underwent modified radical mastectomy.
15947518|NCT03283332|Other|No intervention|
15947519|NCT03283319|Biological|3.75 ug Panblok H7|0.5 mL recombinant Panblok H7 influenza vaccine antigen 15 ug/mL.
15947520|NCT03283319|Biological|7.5 ug Panblok H7|Mix 0.5 mL recombinant Panblok H7 influenza vaccine antigen 30 ug/mL.
15947521|NCT03283319|Biological|15 ug Panblok H7|Mix 0.5 mL recombinant Panblok H7 influenza vaccine antigen 60 ug/mL.
15947522|NCT03283319|Biological|MF59|0.5 mL MF59 (39 mg squalene/mL ) adjuvant.
15947523|NCT03283319|Biological|AS03|0.5 mL AS03 (42.4 mg squalene/mL ) adjuvant.
15947524|NCT03283293|Radiation|Target Volume Delineation after NACT|The gross tumor volumes of the primary site and the neck nodes (GTVnx and GTVnd) were delineated in accordance with the head and neck magnetic resonance imaging (MRI) and endoscopy, which obtained two weeks after the last cycle of NACT. The first clinical target volume (CTV1) was defined as the GTVnx plus a 5-10mm margin (2 to 3mm margin posteriorly) to encompass the high-risk sites of microscopic extension, the whole nasopharynx, and the location and extent of the primary tumor before NACT. The second clinical target volume (CTV2) was defined as the CTV1 plus a 5-10mm margin (2 to 3mm margin posteriorly) to encompass the low-risk sites of microscopic extension, the level of the lymph node located before NACT, and the elective neck area. The prescribed dose to GTVnx, GTVnd, CTV1 and CTV2 were 68Gy/30f, 62-66Gy/30f, 60Gy/30f and 54Gy/30f, respectively.
15947525|NCT03283280|Other|Ever X Posterior|Resin composite restoration can be made as a direct onlay
15947526|NCT03283267|Drug|Sodium Zirconium Cyclosilicate (ZS)|Sodium zirconium cyclosilicate (ZS) is a non-absorbed, inorganic crystalline compound that selectively captures potassium ions in exchange for sodium and hydrogen ions in the gastrointestinal tract after oral administration.
15947527|NCT03283254|Behavioral|Practical Resources for Effective Postpartum Parenting|A preventive psychotherapy intervention for Postpartum Depression
15947528|NCT03283254|Behavioral|Enhanced Treatment As Usual|Psychoeducation about Postpartum Depression, referral to treatment in the community, clinical monitoring
15947529|NCT03283241|Device|Zolidd One ExHex|"Subject will be treated/implanted at visit 2, one of the implants will be chosen as the index implantand will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24."
15947530|NCT03283241|Device|One ExHex|"Subject will be treated/implanted at visit 2, one of the implants will be chosen as the index implantand will be followed together with other implants (maximum 6 implant per subject) at week 8,12 and month 12 and 24."
15947531|NCT03283228|Diagnostic Test|Cd11b and Cd56 markers|The expression of CD11b and CD56 in newly diadnosed cases of AML
15947532|NCT03283215|Diagnostic Test|complete blood count , electrolytes|it is a labarotory test to assess hemoglobin white blood count plate let
15947533|NCT03283202|Drug|Avadomide (CC-122)|Avadomide (CC-122) by mouth at the assigned dose in Ph 1 starting on Day 1 for 5 consecutive days per week, followed by 2 days without avadomide (CC-122) administration (5/7) for the first two weeks of a 21-day treatment cycle. If the highest proposed dose level to be explored in Phase 1 is applied, the dosing regimen will be 5/7 days for all 3 weeks of each 21-day treatment cycle.
15947534|NCT03283202|Drug|Rituximab|Rituxan 375 mg/m2 on Day 1 by intravenous (IV) infusion of a 21-day treatment cycle for up to a total of 6 cycles
15947535|NCT03283202|Drug|Cyclophosphamide 750mg/m2 by IV infusion|Cyclophosphamide 750mg/m2 on Day 1 by IV infusion of a 21-day treatment cycle for up to a total of 6 cycles
15947536|NCT03283202|Drug|Vincristine|Vincristine 1.4 mg/m2 (maximum of 2.0 mg total) on Day 1 by IV bolus on Day 1 of a 21-day treatment cycle for up to a total of 6 cycles
15947537|NCT03283202|Drug|Prednisone|Prednisone 100 mg PO on Days 1 through 5 of each 21-day treatment or 100mg IV on Day 1 is also acceptable for up to a total of 6 cycles
15947538|NCT03283189|Other|Group discussions|The focus group discussions will be conducted in a private room in the maternity of the women. They will last approximately 2 hours and will be led by an interviewer using an interview grid. All interviews will be audio-recorded.
15947539|NCT03283176|Diagnostic Test|Vitamin B12 and Folic Acid|Vitamin B12 and Folic Acid measurement by ELISA technique
15947540|NCT03283163|Behavioral|Exercise Testing and Training|Each study group will perform a baseline maximum load exercise test which will inform the individualized exercise prescription for the participant. Based on a progressive methodology, the participant will engage in 12 weeks of exercise of their choice (walking, running, cycling or swimming) with the goal of working towards a maximum heart rate range of 80% between weeks 6 and 12 of the study.
15947541|NCT03283150|Drug|Remifentanil|Remifentanyl will be administered for 10 -15 minutes before initiating the MER phase and the patient will be allow to wake up and the BIS values to normalize to awake level for the MER.
15947542|NCT03283150|Drug|Propofol|Propofol will be administered for 10 -15 minutes before initiating the MER phase and the patient will be allow to wake up and the BIS values to normalize to awake level for the MER.
15947543|NCT03283150|Drug|Dexmedetomidine|Dexmedetomidine will be administered for 10 -15 minutes before initiating the MER phase and the patient will be allow to wake up and the BIS values to normalize to awake level for the MER.
15947544|NCT03283137|Drug|TGR-1202|TGR-1202 will be given at a dose of 600mg (dose level 1) or 800mg (dose level 2). If the dose of 600mg is tolerated in the first cohort, then the dose will be increased to 800mg which is the only and final dose escalation. If the dose of 600mg is not tolerated, then the dose will be decreased to 400mg daily.
15947545|NCT03283137|Drug|Pembrolizumab|Pembrolizumab will be given at 200 mg every 3 weeks. The dose will not be adjusted throughout the course of the study.
15947546|NCT03283124|Procedure|pelvic floor reconstructive surgery|transvaginal mesh implantation for pelvic organ prolapse
15947547|NCT03283111|Biological|autologous stem cell transplantation|autologous stem cell transplantation
15947548|NCT03283098|Drug|Etelcalcetide|Etelcalcetide was supplied as a sterile, preservative-free, aqueous solution in a single-use 3 mL glass vial.
15947549|NCT03283098|Drug|Placebo|Placebo supplied to match active intervention.
15947550|NCT03283085|Drug|25 mg Ontamalimab|Ontamalimab sterile aqueous buffered solution will be administered in dose of 25 mg subcutaneously.
15947551|NCT03283085|Drug|75 mg Ontamalimab|Ontamalimab sterile aqueous buffered solution will be administered in dose of 75 mg subcutaneously.
15947552|NCT03283072|Device|Hypoxicator|Repeated bouts of hypoxia/normoxia
15947553|NCT03283059|Drug|Octohydroaminoacridine Succinate|Octohydroaminoacridine Succinate Tablet:4mg P.O. tid
15947554|NCT03283059|Drug|Aricept|Aricept 5mg/day, P.O.
15947555|NCT03283059|Drug|Placebos|Placebo Tablet: P.O. tid
15947556|NCT03283046|Drug|Nivolumab|"Dose Escalation Phase Starting Dose: Nivolumab 1 mg/kg by vein over 60 minutes every 3 weeks for 4 doses, followed by Nivolumab 240 mg by vein every 2 weeks until disease progression or unacceptable toxicity on Days 1 and 15 each cycle.
~Dose Expansion Phase Starting Dose: Maximum tolerated dose (MTD) from Dose Escalation Phase.
~Maintenance: Nivolumab 240 mg by vein every 2 weeks until disease progression or unacceptable toxicity on Days 1 and 15 each cycle."
15947557|NCT03283046|Drug|Lenalidomide|"Dose Escalation and Dose Expansion Dose: Lenalidomide 25 mg by mouth on Days 1- 14 in 21 day cycles and Days 1-21 in 28 day cycles.
~Maintenance: Lenalidomide 10 mg by mouth on Days 1-21."
15947558|NCT03283046|Drug|Dexamethasone|Dose Escalation and Dose Expansion Dose: Dexamethasone 40 mg by mouth on Days 1,8,15 in 21 day cycles and 1,8,15 and 22 in 28 day cycles
15947559|NCT03283046|Drug|Ipilimumab|"Dose Escalation and Dose Expansion Dose: Ipilimumab 1 mg/kg by vein over 90 minutes every 3 weeks for 4 doses.
~Maintenance: If there is evidence of disease progression, Ipilimumab reintroduced at 3 mg/kg every 3 weeks for 4 doses. (Nivolumab dose in Combination determined by the phase 1 portion)."
15947562|NCT03283020|Drug|RemifentanilMNTX|Remifentanil infusion TCI 3 ng/ml, Methylnaltrexone injection 0.3 mg/kg
15947563|NCT03283020|Drug|PlaceboMNTX|Placebo (NaCl 0.9%) TCI infusion, Methylnaltrexone injection 0.3 mg/kg
15947564|NCT03283007|Drug|Nintedanib|Eligible LTx recipients with BOS receive Nintedanib treatment at a dose of 150 mg twice daily (bid) for 6 months
15947565|NCT03283007|Drug|Placebo|Eligible LTx recipients with BOS receive Nintedanib 150 mg BID matching placebo treatment for 6 months
15947566|NCT03282994|Device|Dermal Cooling System|Cryotherapy
15947567|NCT03282981|Drug|Timolol|Topical application of Timolol on non-healing diabetic foot ulcers
15947568|NCT03282981|Drug|Non biologically active gel|Topical application of non biologically active gel (Hydrogel- standard of care) on non-healing diabetic foot ulcers
15947569|NCT03282968|Device|REWIRE|First, the patient will play the Fruit Catcher (weight transfer) game on the 3rd level for 3 minutes, followed by 3 minutes of rest. Next, the patient will play the Horse Runner (squats) on the 3rd level for 3 minutes, followed by 3 minutes of rest. In the end, the patient will play the Animal Hurdler (standing on one leg) on the 3rd level for 3 minutes. During the games, the patient will be standing on the Wii Balance Board, holding to a firm support if necessary. During the rest periods, the patients will be sitting. A physiotherapist will be present throughout the exercise for safety and help if requested.
15947570|NCT03282968|Other|Balance exercises|The patient will first practice balance transfer for 3 minutes (standing by a ladder, holding position on each leg for 3 seconds), followed by 3 minutes of rest. Next, the patient will be performing squats for 3 minutes, followed by 3 minutes of rest. In the end, the patient will practice alternatively lifting lower limbs (like stepping on a footstool) for 3 minutes. During the rest periods, the patients will be sitting. A physiotherapist will be present throughout the exercise for safety and help if requested.
15947573|NCT03282942|Other|Strength training group|"Individuals in the strength training group will perform exercises based on exercises with free weights and equipment, for upper and lower limbs with a weekly frequency of three times for twelve weeks. The periodization will start with 2 sets, 15 - 20 repetitions, passive rest of 120 seconds, exercises performed alternating by segments and the intensity of 50% of maximum repetition. After twelve weeks the periodization will be finished with 3 sets, 8-12 repetitions, passive rest of 120 seconds, exercises performed alternated by segments and the intensity of 70% of maximum repetition.
~The following exercises will compose the strength training protocol:
~Squatting
~Leg press
~Knee Extension
~Knee Flexion
~Supine Challenge
~High Pull
~Elbow flexion
~Extension of elbows
~Development
~Abdominal"
15947574|NCT03282942|Other|Aerobic Training Group|Individuals in the aerobic training group will perform aerobic treadmill exercise three times a week for twelve weeks. The training prescription will be performed through the percentage of maximum oxygen consumption with intensity in 60% to 80% with an average duration of 50 minutes of continuous exercise.
15947575|NCT03282929|Device|Part 1|A single dose of 500 μg epinephrine (0.5 mL Suprarenin®) will be administered i.m. and s.c. by using a needle and a syringe in randomized order
15947576|NCT03282929|Device|Part 2 Group 1|300 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)
15947577|NCT03282929|Drug|Part 2 group 2|500 μg epinephrine auto-injector (Emerade, Bausch and Lomb, 23 mm needle length)
15947578|NCT03282929|Device|Part 2 group 3|300 μg epinephrine auto-injector (Fastjekt, MEDA Pharma, 16 mm needle length)
15947579|NCT03282929|Device|Part 2 Group 4|300 μg epinephrine auto-injector (Jext, Alk-Abelló, 15 mm needle length)
15947580|NCT03282916|Drug|Valacyclovir|Valacyclovir hydrochloride 500g caplet
15947581|NCT03282916|Drug|Placebo|Placebo sugar pill 500mg caplet
15947582|NCT03282890|Other|CHRP-BB|The CHRP-BB intervention is a theory-based, manual-guided, HIV risk reduction and PrEP adherence intervention. It is an integrated evidence-based intervention that uses a coping skills training approach to primary prevention and is delivered in a small group modality by two trained intervention facilitators using a motivational enhancement therapeutic style to address high risk drug- and sex-related HIV risk behaviors and PrEP adherence. Importantly, the CHRP-BB intervention includes specific behavioral and mHealth strategies designed and tested to accommodate difficulties stemming from moderate to severe neuro-cognitive impairment (NCI).
15947583|NCT03282877|Behavioral|iCST web-application|The iCST web-application will be delivered by a carer in regular contact with the person with dementia (family carer, a close friend, or a volunteer befriender) for 1.5 hours a week. It is up to the carer to distribute the time in a matter that is convenient to them (e.g. two long sessions of 45 minutes or 3 shorter sessions of 30 minutes). Participants will be asked to use the web-application for a duration of 11 weeks at their homes. Each session will consist of structured cognitive stimulation aided by the use of multimedia. After completing each session, participants will be guided to a new screen on the web-application in which they will be asked to briefly reflect on the session and provide us with feedback.
15947584|NCT03282864|Device|Bedroom air filtered by an air filtration device to remove airborne pollutants|The air in the bedroom of study subjects in the active comparator arm was processed by an air filtration device which pulled air through a pre-filter, a high efficiency particular air (HEPA) filter and an active carbon filter continuously. The air in the bedroom of subjects in the placebo arm was processed by a placebo air filtration device that looked identical to the real air filtration device but did not possess the HEPA filter and the active carbon filter. Each subject was assigned to the active comparator arm and the placebo arm in a randomized order with a two-week washout period scheduled in-between. The subjects, their guardians and the study staff that assessed the health indicators of the subjects were blinded to this order till the end of the study.
15947585|NCT03282851|Drug|MSB11456|Subjects will receive a single injection of MSB11456 on Day 1.
15947586|NCT03282851|Drug|US-licensed Actemra|Subjects will receive a single injection of US-licensed actemra on Day 1.
15947587|NCT03282851|Drug|EU-approved RoActemra|Subjects will receive a single injection of EU-approved RoActemra on Day 1.
15947588|NCT03282838|Drug|DFN-15 (fasted)|DFN-15 administered to fasted subjects
15947589|NCT03282838|Drug|DFN-15 (fed)|DFN-15 administered to fed subjects
15947590|NCT03282838|Drug|Comparator Celebrex® (fed)|Comparator (Celebrex®) administered to fed subjects
15947591|NCT03282825|Drug|Decitabine|"The subjects will be sequential administered with Decitabine and paclitaxel 80mg/m2 by IV(intravenous) infusion.
~Decitabine is starting dose of 15mg/m2 on 1D, 8D, 22D, 28D of a 28day cycle. Paclitaxel 80mg/m2 will be dosed in combination therapy with Decitabine on 8D, 22D, 28D of a 28day cycle."
15947592|NCT03282825|Drug|Paclitaxel|"The subjects will be sequential administered with Decitabine and paclitaxel 80mg/m2 by IV(intravenous) infusion.
~Decitabine is starting dose of 15mg/m2 on 1D, 8D, 22D, 28D of a 28day cycle. Paclitaxel 80mg/m2 will be dosed in combination therapy with Decitabine on 8D, 22D, 28D of a 28day cycle."
15947593|NCT03282799|Drug|etonogestrel implant|The etonogestrel implant is an contraceptive implant that is placed into the upper arm.
15947594|NCT03282786|Other|carbon dioxide insufflation during colonoscopy|Use of Carbon dioxide instead of air insufflation
15947595|NCT03282773|Device|Deferred stent implantation|Primary angiography and pretreatment including balloon dilatation and thrombus aspiration, second generation drug-eluting stents are implanted 4-10 days after restoration of blood flow in left main coronary artery in a secondary PCI.
15947596|NCT03282773|Device|Immediate stent implantation|Primary angiography and pretreatment including balloon dilatation and thrombus aspiration, second generation drug-eluting stents are implanted immediately after restoration of blood flow in left main coronary artery in a secondary PCI.
15947597|NCT03282760|Biological|Human Neural Stem Cells|Allogenic human Neural Stem Cells (hNSCs) in four different dosages (5, 10, 16 or 24 millions). hNSCs are produced by the Laboratorio Cellule Staminali of Terni according to GMP guidelines and are obtained from brain specimens of several fetal human donors from spontaneous miscarriages occurred after the 8th week after conception.
15947598|NCT03282747|Behavioral|no intervention|no intervention
15947599|NCT03282734|Other|Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.)|Home-based exercise program with smart rehabilitation system ((Uincare®, D-gate Co.) for more than 30 minutes per a day for 4 weeks
15947600|NCT03282734|Other|Conventional home rehabilitation exercise|Conventional home rehabilitation exercise for more than 30 minutes per a day for 4 weeks
15947601|NCT03282721|Procedure|precise location of commissure|
15947602|NCT03282708|Other|Fresh stool collection|"One sample collection of spontaneously produced fresh stool (of an approximate size of 3 green beans).
~Data collection with self-administered questionnaire"
15947603|NCT03282682|Procedure|Strength training|The participants perform strength training sessions two times per week for 12 weeks. Each training session include 5-minute general dynamic warm-up followed by progressive strength training with exercises for the entire body. The strength exercises are performed with free weights and on machines. The training program consist of 6 exercises for upper and lower body at an intensity of 60-80% (8 - 12RM: the load that induces technique failure in eight or twelve repetitions) of one-repetition maximum and takes approximately 60 minutes. The exercises performed are: leg press, split squats, bench press, knee extension, knee flexion, seated cable rows, seated cable pull downs, dumbbell bench press, incline dumbbell bench press.
15947604|NCT03282669|Drug|Intrathecal Morphine|Intrathecal Morphine administered in the operating room.
15947606|NCT03282656|Biological|single infusion of autologous bone marrow derived CD34+ HSC cells transduced with the lentiviral vector containing a short-hairpin RNA targeting BCL11a|single infusion of autologous bone marrow derived CD34+ HSC cells transduced with the lentiviral vector containing a short-hairpin RNA targeting BCL11a
15947607|NCT03282643|Drug|Rivaroxaban 10 MG|Rivaroxaban pill 10mg qd, day1 and day2 after femoral venepuncture
15947608|NCT03282643|Drug|Rivaroxaban 20 MG|Rivaroxaban pill 10mg bid, day1 and day2 after femoral venepuncture
15947609|NCT03282643|Drug|Low-molecular-weight heparin|0.4 ml once daily, before femoral venepuncture(day1) and the following day (day 2)
15947610|NCT03282630|Procedure|Sphenopalatine ganglion acupuncture|"active sphenopalatine ganglion acupuncture The acupuncture point was selected in the sphenopalatine ganglion (unilateral side). The acupuncture needle was inserted from the lower border of the zygomatic arch, slightly posterior to the suture protuberance between the zygomatic process
~sham sphenopalatine ganglion acupuncture The acupuncture point was selected same to the sphenopalatine ganglion. But the needle was inserted at the selected acupuncture site to a depth of only 2-3cm, and the procedure of rotating, twirling and thrusting the needle was repeated, in order to blind the subject to the sham treatment."
15947611|NCT03282617|Biological|CD137L-DC-EBV-VAX|Patients will receive CD137L-DC-EBV-VAX at a dose of approximately 5-50 millioncells every 2 weeks, for a total of 5-7 times.
15947612|NCT03282591|Drug|5 mg Serlopitant Tablets|Serlopitant Tablets
15947613|NCT03282591|Drug|Matching Placebo Tablets|Placebo Tablets
15947614|NCT03282578|Device|Sternalock 360 sternal plating system|The SternaLock 360 system is a band and plating system designed to improve sternal stability. 3 bands surround the sternum to oppose the bones (like wires), but an additional 3 plate system prevents anterior posterior displacement and provides a rigid fixation.
15947615|NCT03282578|Device|Sternal Wires|"Stainless steel wires are applied in a figure of 8 configuration to close the sternum"
15947616|NCT03282565|Other|Functional Resistance Training|A brace/cuff/exercise band will be strapped to the leg and apply resistance across the knee while subjects walk on a treadmill.
15947617|NCT03282565|Other|Control|A brace/cuff/exercise band will be strapped to the leg and will not apply resistance across the knee while subjects walk on a treadmill.
15947618|NCT03282552|Device|Nasal Cannula High Flow Oxygen|Nasal Cannula High Flow Oxygenation will be implemented at these study groups . (1st study group, and 2nd study group)
15947619|NCT03282539|Device|LAMS|EUS-guided transmural drainage of pancreatic fluid collections with lumen apposing metal stents
15947620|NCT03282539|Device|LAMS + pigtail|EUS-guided transmural drainage of pancreatic fluid collections with lumen apposing metal stents and a coaxial double pigtail stent
15947621|NCT03282526|Diagnostic Test|Whole body plethysmography|Whole body plethysmography : measure lung volumes Spirometry : to assess severity of chronic obstructive pulmonary disease also reversibility testing
15947622|NCT03282513|Drug|AG-120 (Ivosidenib)|Single 500 mg dose of AG-120 (Ivosidenib).
15947623|NCT03282500|Behavioral|Mindfulness Based Cognitive Therapy|The Mindfulness Based Cognitive Therapy (MBCT) intervention promotes self-regulation of emotions and behaviors within an accepting and non-judgmental therapeutic environment. During this interactive, multisensory program, participants will learn strategies to help manage their emotions and thoughts and help them to develop greater insight into the influence these experiences have on their behaviors. Participants will engage in brief at home exercises to enhance their learning of these new skills.
15947624|NCT03282487|Drug|Modified release hydrocortisone|Patients will switch from their usual conventional immediate release hydrocortisone to daily dose equivalent of modified release hydrocortisone (Plenadren®)
15947625|NCT03282474|Drug|Sofosbuvir|Sofosbuvir 400 MG Oral Tablet [Sovaldi]
15947626|NCT03282461|Drug|ABY-029|A sample size of 6-12 patients in this open label, single center, clinical trial of ABY-029. Administration will occur as a single intravenous injection to subjects with operable head and neck cancer approximately 1-3 hours prior to surgery.
15947627|NCT03282448|Behavioral|family therapy|The family-based intervention is informed by Dialectical Behavior Therapy Skills Training for Adolescents (Rathus & Miller, 2014).
15947628|NCT03282435|Biological|CIK cells with PD-1 blocking|CIK cellular therapy with PD-1 blocking
15947629|NCT03282435|Other|standard lung cancer treament|standard non-small cell lung cancer treatment: surgery, chemotherapy
15947630|NCT03282435|Biological|CIK cells without PD-1 blocking|CIK cellular therapy without PD-1 blocking
15947631|NCT03282422|Device|Home-based protocol in specific tasks|The home-based protocol in specific tasks will be an individualized protocol designed for the child according to the results of the baseline assessment and will require active participation. It is a program that is integrated into the daily routines of the child. A study investigator will tell the family the procedure to follow.
15947632|NCT03282422|Device|Upper-limb splint|In the case that treatment with splint is also received, a researcher of this study will take measurements of the hand and will provide the appropriate splint. The intensity of the application will be 5 days a week from monday to friday, for 6 hours a day, for a period of 6 weeks.
15947633|NCT03282396|Drug|Ibrutinib|Given PO
15947634|NCT03282370|Biological|JEVAX|JEVAX - VABIOTECH Vietnam Liquid form Subcutaneous injection 0.5ml/dose, 2 doses, 28-34 days interval
15947635|NCT03282370|Biological|JECEVAX|JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 28-34 days
15947636|NCT03282357|Device|Radiesse injectable implant (dermal filler)|Subdermal injection.
15947637|NCT03282357|Device|Restylane injectable implant (dermal filler)|Subdermal injection
15947638|NCT03282344|Drug|NKTR-214|0.006mg/kg IV on day 1 and every 3 weeks thereafter will be an intravenous (IV) infusion administered over 30 (±5) minutes every 3 weeks.
15947639|NCT03282344|Drug|Nivolumab|360mg (flat dose) IV infusion administered over 30 (±5) minutes every 3 weeks.
15947640|NCT03282331|Procedure|Standard oxygenation|Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation
15947641|NCT03282331|Procedure|High flow nasal oxygenation|Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation
15947642|NCT03282331|Procedure|noninvasive ventilation|Electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : Comparison of Standard Oxygenation, High Flow Nasal Oxygen Therapy, and NonInvasive Ventilation
15947643|NCT03282318|Drug|ASP6294|Participants will receive 320 mg ASP6294 subcutaneous injection at 4-week intervals at baseline (Day 1/Week 0), Week 4 and Week 8.
15947644|NCT03282318|Drug|Placebo|Participants will receive placebo to match 320 mg ASP6294 subcutaneous injection at 4-week intervals at baseline (Day 1/Week 0), Week 4 and Week 8.
15947645|NCT03282292|Procedure|Internal jugular vein CVC insertion|Double lumen CVC insertion in the internal jugular vein
15947646|NCT03282279|Procedure|TVOR|Ultrasound guided transvaginal oocyte retrieval (TVOR) in deep sedation for IVF.
15947649|NCT03282240|Biological|QIV-HD|0.7 mL-dose was administered intramuscularly (IM) into the upper arm area.
15947650|NCT03282240|Biological|Licensed TIV-HD1|0.5 mL-dose was administered IM into the upper arm area.
15947651|NCT03282240|Biological|Investigational TIV-HD2|0.5 mL-dose was administered IM into the upper arm area.
15947652|NCT03282227|Drug|M207 Microneedle System|M207 Microneedle System 3.8 mg
15947653|NCT03282214|Behavioral|Self-management energy conservation|"The experimental group will receive four sessions approximately every three weeks with the PI. These sessions will correspond to the cycles of chemotherapy they will receive, with the first two sessions being during cycle 1, and sessions 3 and 4 being during cycles 2 and 3 of chemotherapy, respectively. The women will be instructed on how to assess their activity patterns by making a list prioritizing their usual activities. The journal and priority list (a to do list) provide the basis for the second session. In this session, the participant will learn to create a plan for managing valued activities to minimize the amount of energy used, to report the fatigue experienced during and after an activity done in the journal and will learn strategies to manage fatigue and optimize activity. In the third session, the participant will evaluate and revise their individualized plan. In addition, the participant will be instructed to wear a pedometer to record objective physical activity."
15947654|NCT03282201|Other|Transfusion|Transfusion of red blood cells, fresh frozen plasma, platelets
15947655|NCT03282188|Biological|Reolysin|Reolysin® is a proprietary isolate of Reovirus Type 3 Dearing, a non-enveloped human reovirus with a genome that consists of 10 segments of double-stranded RNA. The human reovirus possesses an innate ability to replicate specifically in transformed cells possessing an activated Ras signalling pathway, a situation often found in malignant cells. Reovirus has been shown to reach and target melanoma cancer cells.
15947656|NCT03282188|Drug|GM-CSF|GM-CSF is a recombinant human granulocyte-macrophage colony stimulating factor (rhu GM-CSF) produced by recombinant DNA technology in a yeast (S. cerevisiae) expression system. GM-CSF is a hematopoietic growth factor which stimulates proliferation and differentiation of hematopoietic progenitor cells. GM-CSF is a key cytokine in the differentiation of dendritic cells. It has been used as an immune adjuvant in therapeutic vaccines in pre-clinical and clinical studies, administered as cytokine released from gene-transduced tumour or stromal cells or as recombinant protein. At low doses GM-CSF may enhance migration and differentiation of dendritic cells to local antigen presentation, and is a potent adjuvant to generate specific systemic anti-tumour efficacy.
15947657|NCT03282175|Other|Exercise|Exercise session consisted of general warm-up of 10 min, followed by 35-40 min of resistance exercises (chair squats, band seated: biceps curl, seated row, knee extension, leg press and hip abduction; standing behind the chair: knee flexion, and calf rise), and general cool down of 10 min.
15947658|NCT03282175|Other|Training|Each training session consisted of general warm-up of 10 min, followed by 35-40 min of resistance exercises (chair squats, band seated: biceps curl, seated row, knee extension, leg press and hip abduction; standing behind the chair: knee flexion, and calf rise), and general cool down of 10 min.
15947659|NCT03282175|Other|Control group|The control group did not receive any treatment.
15947660|NCT03282162|Drug|intranasal oxytocin|Each subject will be assigned to intranasal administration of oxytocin (24 IU).
15947661|NCT03282162|Drug|intranasal placebo|An identical amount of intranasal administration of placebo will be assigned to each subject.
15947662|NCT03282149|Biological|XT-150|IL-10 transgene DNA plasmid injected into the knee synovial capsule
15947663|NCT03282136|Drug|Incretin Effect|The patients will receive incretins therapy.
15947664|NCT03282136|Device|Cardiac Resynchronization therapy defibrillator device|The patients will receive a Cardiac Resynchronization therapy defibrillator device
15947665|NCT03282123|Drug|MDMA|80 to 120 mg MDMA
15947666|NCT03282123|Behavioral|Therapy|Non-directive therapy conducted during MDMA-assisted therapy session
15947667|NCT03282110|Device|ta-VNS|The transcutaneous vagus nerve stimulation (taVNS) at auricular concha is a typical representative of TCM modernization. The taVNS regulates the autonomic nervous system, which shows a good therapeutic effect for the treatment of depression.
15947668|NCT03282110|Other|Electro-acupuncture|one of the most common acupuncture methods, selecting acupoints based on traditional Chinese medicine theory. It exerts the function to regulate qi and blood circulation and balance Yang and Yin energy inside body.
15947669|NCT03282110|Drug|Citalopram|Citalopram is an antidepressant drug of the selective serotonin reuptake inhibitor (SSRI) class.It has U.S. Food and Drug Administration approval to treat major depression.
15947670|NCT03282097|Behavioral|DECAD decision aid|A mammography decision aid that will help caregivers of patients with Alzheimer's make decisions about stopping or continuing breast cancer screening.
15947671|NCT03282097|Other|Home safety guide|The home safety guide provides tips about important actions older adults can take to prevent falls, poisoning, and bathroom hazards and protection against abuse, fire and other related hazards.
15947672|NCT03282084|Diagnostic Test|EGD with biopsy|Stop PPI and schedule for EGD with biopsy and Wireless pH capsule testing for 7-10 days later. Consider gastric emptying scan or high resolution esophageal manometry
15947673|NCT03282084|Diagnostic Test|EGD and impedance-pH study on PPI|Continue PPI and schedule EGD and Impedance-pH study on PPI. Consider gastric emptying scan or high resolution esophageal manometry
15947674|NCT03282071|Behavioral|Joyful Parenting Intervention|"Two-session interactive talks for parents to promote praise & appreciation, positive thinking, enjoyable parenting (mind) and knowledge of adult mental health problem (in particular the mixed anxiety and depressive disorder) and mental well-being.
~One family gathering activity (e.g. outdoor / visit / family indoor gathering) to promote and practise quality family communication (enjoyment and sharing)."
15947675|NCT03282058|Device|Silastic Stent|The silastic stent is a splint made of silicone.
15947676|NCT03282045|Drug|Lysobact Complete Sprey|Inhaling spray
15947677|NCT03282045|Drug|Tantum Verde® Spray|Inhaling spray
15947678|NCT03282045|Drug|Pharyngal® Oromucosal Spray|Inhaling spray
15947679|NCT03282045|Drug|Placebo|Inhaling spray
15947680|NCT03282032|Other|One-lung ventilation|"The patient undergoing thoracic surgery is intubated with double lumen tube after induction of general anesthesia with propofol and remifentanil.
~In the intervention group, 5 cycles of one-lung ventilation preconditioning (2-min of one-lung ventilation and 2-min of two-lung ventilation for 1 cycle) is performed before surgical incision. One-lung ventilation is done at dependent lung with FiO2 100% and tidal volume 6 ml kg-1. Two-lung ventilation is done with FiO2 50%, tidal volume 8 ml kg-1."
15947681|NCT03282019|Device|High-flow nasal cannula therapy|Subjects will receive nocturnal high-flow nasal cannula therapy with the myAIRVO2®, in addition to their current Home oxygen therapy (HOT). The myAIRVO2® is used for at least 4 hours per day with flow rates in the range 30-40 L/min. The investigator can adjust the nocturnal oxygen flow rates to keep SpO2 88-92% stably. If the subjects report discomfort, the investigator can adjust the flow rates in the range at least 20 L/min.
15947682|NCT03282019|Device|Home oxygen therapy (HOT)|All subjects will continue their current Home oxygen therapy (HOT) which kept original usage conditions at the time of enrollment throughout the entire duration of the study regardless of treatment arm assignment.
15947683|NCT03282006|Drug|pivmecillinam|Oral treatment of bacteremic pyelonephritis following standard initial parenteral treatment
15947684|NCT03281993|Other|CPAP AT|If the investigators observe rapid desaturation defined as a decline in O2 saturation below 85%; the CPAP apnea test (CPAP-AT) test was aborted.
15947685|NCT03281980|Other|Psychosocial stimulation (PS)|"i) Unconditional Cash Transfer(UCT)/ Maternity Allowance: MoWCA, GoB provides maternity allowance of taka 500 ($6.25) for each mother up to two years in each month.
~ii) Health Education Awareness Program: All mothers receive health education training by designated LNGOs/CBOs
~iii) Psychosocial stimulation: The participants will receive fortnightly sessions at home."
15947686|NCT03281980|Other|Government Intervention (UCT+HE)|fgbfgjhgykghilk
15947687|NCT03281967|Device|Minimally Invasive Ponto Surgery|Minimally Invasive Ponto surgery is used for hearing rehabilitation using Ponto Wide Implant in patients indicated and counselled for Bone Anchored Hearing System.
15947688|NCT03281954|Drug|Placebo|"Following randomization, patients will receive Paclitaxel 80 mg/m2 IV weekly x 12 doses + Carboplatin AUC of 5 IV Day 1 every 3 weeks for 4 cycles + placebo IV Day 1 every 3 weeks for 4 doses.
~Followed 2-3 weeks later by Doxorubicin (A) 60 mg/m2 IV + cyclophosphamide (C) 600 mg/m2 IV Day 1 every 2 or 3 weeks for 4 cycles OR Epirubicin (E) 90 mg/m2 IV + cyclophosphamide (C) 600 mg/m2 IV Day 1 every 2 or 3 weeks for 4 cycles.
~+ placebo IV Day 1 every 3 weeks for 3 to 4 doses depending on AC/EC schedule used.
~Approximately 3-4 weeks later: Surgery (Lumpectomy or mastectomy and axillary staging), followed by placebo IV Day 1 every 3 weeks after surgery until 1 year after the first dose."
15947689|NCT03281954|Drug|Atezolizumab|"Following randomization, patients will receive Paclitaxel 80 mg/m2 IV weekly x 12 doses + Carboplatin AUC of 5 IV Day 1 every 3 weeks for 4 cycles + Atezolizumab 1200 mg Day 1 every 3 weeks for 4 doses.
~Followed 2-3 weeks later by Doxorubicin (A) 60 mg/m2 IV + cyclophosphamide (C) 600 mg/m2 IV Day 1 every 2 or 3 weeks for 4 cycles OR Epirubicin (E) 90 mg/m2 IV + cyclophosphamide (C) 600 mg/m2 IV Day 1 every 2 or 3 weeks for 4 cycles.
~+ Atezolizumab 1200 mg Day 1 every 3 weeks for 3 to 4 doses depending on AC/EC schedule used.
~Approximately 3-4 weeks later: Surgery (Lumpectomy or mastectomy and axillary staging), followed by Atezolizumab 1200 mg Day 1 every 3 weeks after surgery until 1 year after the first dose."
15947690|NCT03281941|Other|Inhaled capsaicin cough challenge|
15947691|NCT03281928|Dietary Supplement|Sodium and Potassium Citrate|Sodium and potassium citrate levels will be altered in diet and renal mineral handling will be measured as compared to placebo.
15947692|NCT03281928|Dietary Supplement|Placebo|Sodium without Potassium Citrate
15947693|NCT03281915|Procedure|High inguinal Varicocelectomy|Semen parameters after high inguinal varicocelectomy will be collected
15947694|NCT03281915|Procedure|Subinguinal varicocelectomy|Semen parameters after subinguinal Varicocelectomy will be collected
15947695|NCT03281902|Procedure|Biopsy|Undergo tumor biopsy
15947696|NCT03281902|Procedure|Biospecimen Collection|Undergo collection of blood, urine, stool, and saliva
15947697|NCT03281902|Other|Laboratory Biomarker Analysis|Correlative studies
15947698|NCT03281889|Radiation|Proton Beam|precision radiation that reduce the negative effects radiation has on the surrounding non-cancerous growing and developing tissue
15947699|NCT03281876|Biological|NTHi Mcat investigational vaccine (GSK3277511A)|Two doses administered intramuscularly at Day 1 and Day 61 in the deltoid region of the non-dominant arm.
15947700|NCT03281876|Biological|Placebo|Two doses administered intramuscularly at Day 1 and Day 61 in the deltoid region of the non-dominant arm.
15947701|NCT03281863|Diagnostic Test|C reactive protein, anti streptolysin o antibody test ,erythrocyte sedimentation rate|Throat culture to detect the causative organism
15947702|NCT03281837|Device|HYMOVIS plus Physical Exercise Program (PEP)|1 injection of intra-articular (IA) hyaluronan (HA), Hymovis 24mg/3ml, injection per week for 2 weeks combined with at least 8 weeks of Physical Exercise Program (PEP)
15947703|NCT03281837|Other|Physical Exercise Program (PEP) alone|Physical Exercise Program (PEP) alone for at least 8 weeks
15947704|NCT03281824|Biological|ALT-P7 (HM2-MMAE)|Antibody-Drug Conjugate
15947705|NCT03281811|Drug|Aminolevulinic Acid Hydrochloride|Given topically
15947706|NCT03281811|Drug|Photodynamic Therapy|Undergo PDT
15947707|NCT03281811|Other|Quality-of-Life Assessment|Ancillary studies
15947708|NCT03281811|Radiation|Radiation Therapy|Undergo RT
15983806|NCT03009032|Dietary Supplement|Placebo|Lactose
15947709|NCT03281798|Device|Karl Storz Semi-Rigid TTTS Fetoscopy Instrument Set|2.0 mm fetoscopy or flexible ureteroscope
15947710|NCT03281785|Other|Pressure controlled mandatory ventilation mode (P-CMV)|Pressure controlled mandatory ventilation mode (P-CMV)
15947711|NCT03281785|Other|Pressure synchronized intermittent mandatory ventilation|Pressure synchronized intermittent mandatory ventilation
15947712|NCT03281785|Other|Pressure support mode (PS)|Pressure support mode (PS)
15947713|NCT03281772|Other|Clinical Decision Software - provider portal|As noted in Arms
15947714|NCT03281772|Other|Clinical Decision Software - patient portal|As noted in Arms
15947715|NCT03281759|Device|Transcranial LED Therapy (Active coil helmet)|The patients will undergo 18 sessions of repetitive transcranial LED stimulation.
15947716|NCT03281759|Device|Transcranial LED Therapy (Inactive coil helmet)|The patients assigned to this group will undergo 18 sessions of transcranial LED but with an inactive coil, which will not generate LED emissions, only a similar red light color.
15947717|NCT03281746|Procedure|Dental Procedure|Undergo dental examination
15947718|NCT03281746|Other|Educational Intervention (prevention education)|Receive prevention education
15947719|NCT03281746|Other|Interview|Ancillary studies
15947720|NCT03281746|Other|Survey Administration|Ancillary studies
15947721|NCT03281746|Other|Educational Intervention (one-on one education)|Receive one-on-one education
15947722|NCT03281720|Procedure|TAD|the same intervention as listed in the arm description
15947723|NCT03281707|Procedure|NIRS|NIRS devices patch will be applied on patients' head in order to measure the cerebral saturation of each cerebral emisphere
15947724|NCT03281707|Other|DO2i|Oxygen delivery standardized to the body surface area will be calculate in order to optimize tissue perfusion
15947725|NCT03281694|Drug|Placebo|placebo skin patch and placebo oral solution
15947726|NCT03281694|Drug|Nicotine|nicotine skin patch (7 mg/24 hrs) and placebo oral solution
15947727|NCT03281694|Drug|AVL-3288|placebo skin patch and AVL-3288 oral solution (3 mg)
15947728|NCT03281694|Drug|Nicotine + AVL-3288|nicotine skin patch (7 mg/24 hrs) and AVL-3288 oral solution (3 mg)
15947729|NCT03281681|Drug|VAL-083, Dianhydrogalactitol|VAL-083 given by intravenous infusion with a starting dose of 60 mg/m2 once weekly. If this regimen is well tolerated for at least three sequential weekly treatments the patient's dose may be escalated to 67 mg/m2 i.v. If the 67 mg/m2 dose is well tolerated for at least three sequential weekly treatments the patient's dose may be escalated to 75 mg/m2 i.v. once weekly for the remainder of the study. Dosing will be conducted once per week for a total of 16 weeks.
15947730|NCT03281668|Behavioral|High intensity interval training (HIIT)|Each training session for High Intensity Interval Training will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.
15947731|NCT03281655|Drug|Visnadine, prenylflavonoids and bovine colostrum|15 days, 1 application per day, with a vaginal cream containing visnadine, prenylflavonoids and bovine colostrum.
15947732|NCT03281642|Other|Tobacco management|Training of healthcare teams for tobacco management by trained nurses. The intervention will consist of 3 minimum interviews, about 30 minutes each.
15947733|NCT03281629|Device|Active TMS stimulation|Multiple trains of active transcranial magnetic stimulation in a day, for multiple days.
15947734|NCT03281629|Device|Sham TMS stimulation|Multiple trains of sham transcranial magnetic stimulation in a day, for multiple days.
15947735|NCT03281616|Behavioral|Diet|Individually tailored diets; 30% caloric reduction according to daily energy requirements measured by indirect calorimetry
15947736|NCT03281603|Device|CAD/CAM complete denture|complete denture will be designed by computer aided designing (CAD) and manufactured by computer aided manufacturing(CAM) utilizing Milling and 3D printing techniques
15947737|NCT03281577|Drug|TAK-954|TAK-954 IV infusion.
15947738|NCT03281577|Drug|Placebo|TAK-954 placebo-matching IV infusion.
15947739|NCT03281564|Other|Quality of life after Essure® removal|Questionnaire to assess the quality of life 1, 3, 6 and 12 months after laparoscopic removal of Essure® device
15947740|NCT03281551|Drug|PZ01 CAR-T cells|Chimeric antigen receptor (CAR) T cells targeting CD19 will be evaluated for safety and efficacy in patients with relapsed/ refractory B-cell Acute Lymphoblastic Leukemia/B cell Lymphoma. The CAR consists of a CD19 targeting antibody scFv with two intracellular signaling domains derived from CD3 zeta and 4-1BB. Autologous T cells will be gene-engineered with the CAR gene using a lentivirus vector. Prior to T cell infusion, the patients will be subjected to preconditioning treatment. After T cell infusion, the patients will be evaluated for 24 months for adverse reactions, persistence of CAR T cells and efficacy.
15947741|NCT03281538|Drug|CR845|IV CR845 0.5 mcg/kg administered after each dialysis session (3 times/week)
15947742|NCT03281499|Other|da Vinci Surgical System Model IS4000|tailored radiotherapy regimen following transoral robotic surgery
15947743|NCT03281486|Device|HA formulation Oral Spray|It is an HA formulation of FDA listed ingredients
15947744|NCT03281486|Device|Placebo|Placebo formulation without the active ingredients
15947745|NCT03281473|Other|Strategy 1|PEEP titration according to transpulmonary-end-expiratory pressure
15947746|NCT03281473|Other|Strategy 2|PEEP titration according to chest wall elastance measurement
15947747|NCT03281460|Device|laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation|laparoscopic myomectomy or hysterectomy with More-cell-Safe AMI bag morcellation
15947748|NCT03281460|Procedure|laparoscopic myomectomy or hysterectomy without any morcellation bag|laparoscopic myomectomy or hysterectomy without any morcellation bag
15947749|NCT03281447|Other|Nurse navigation|
15947750|NCT03281447|Other|Current care coordination|
15947751|NCT03281434|Dietary Supplement|Collagen peptide|Low leucine content protein supplement to be consumed twice daily
15947752|NCT03281434|Dietary Supplement|Whey protein isolate|High quality protein (DIAAS score), high leucine supplement, to be consumed twice daily
15947753|NCT03281421|Other|Manual Therapy|The manual therapy intervention, through the technique of mobilization with movement in the ankle joint (following the specific sense direction of the group), will be performed in a protocol that consists of four sets of five repetitions, with rest time between series of one minute.
15947822|NCT03280771|Combination Product|Control group soap|A colourful, translucent bar or soap with the toy alongside it
15947754|NCT03281395|Procedure|Rapid ventricular pacing (RVP)|Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short period of time during dissection of the aneurysm. RVP results in an adequate fall in blood pressure which presents as an on-off phenomenon. RVP technique facilitates the dissection and manipulation of cerebral aneurysms and arteriovenous malformations and can be lifesaving in the case of an intraoperative bleeding or rupture.
15947755|NCT03281395|Procedure|No rapid ventricular pacing|
15947756|NCT03281382|Biological|Ad5-yCD/mutTKSR39rep-hIL12|Oncolytic adenovirus expressing two suicide genes and human IL-12
15947757|NCT03281369|Drug|5-Fluorouracil (5-FU)|5-FU 2400 milligrams per square meter (mg/m^2) by continuous intravenous (IV) infusion over 46 hours on Days 1 and 2 and Days 15 and 16 of every 28-day cycle.
15947758|NCT03281369|Drug|Leucovorin|Leucovorin: 100 mg/m^2 IV over 2 hours on Days 1 and 15 of every 28-day cycle.
15947759|NCT03281369|Drug|Oxaliplatin|Oxaliplatin: 100 mg/m^2 administered by IV infusion over 2 hours on Days 1 and 15 of every 28-day cycle.
15947760|NCT03281369|Drug|Atezolizumab|Atezolizumab: 840 mg by IV infusion on Days 1 and 15 of every 28-day cycle.
15947761|NCT03281369|Drug|Cobimetinib|Cobimetinib: 60 mg by mouth once a day on Days 1-21 of every 28-day cycle
15947762|NCT03281369|Biological|Ramucirumab|Ramucirumab: 8 mg/kg administered by IV infusion over 60 minutes on Days 1 and 15 of every 28-day cycle.
15947763|NCT03281369|Drug|Paclitaxel|Paclitaxel: 80 mg/m^2 administered by IV infusion on Days 1, 8, and 15 of every 28-day cycle.
15947764|NCT03281369|Biological|PEGylated recombinant human hyaluronidase (PEGPH20)|PEGPH20: 3 micrograms per kilogram (mcg/kg) administered by IV infusion on Days 1, 8, and 15 of every 21-day cycle.
15947765|NCT03281369|Drug|BL-8040|BL-8040: 1.25 mg/kg administered by subcutaneous (SC) injection on Days 1-5 during the 5-day priming period prior to Cycle 1; 1.25 mg/kg administered by SC injection three times a week (Days 1, 3, 5, 8, 10, 12, 15, 17, and 19 of every 21-day cycle).
15947766|NCT03281369|Drug|Linagliptin|Linagliptin: 5 mg orally once a day of every 21-day cycle.
15947767|NCT03281369|Drug|Atezolizumab|Atezolizumab: 1200 mg administered by IV infusion on Day 1 of every 21-day cycle
15947768|NCT03281369|Drug|Cobimetinib|Cobimetinib: 40 or 60 mg (depending on the recommended dose determined during the safety run-in phase) by mouth once a day on Days 1-21 of every 28-day cycle.
15947769|NCT03281369|Drug|Cisplatin|Cisplatin: 80 mg/m^2 administered by IV infusion on Day 1 of each 21 day cycle. Treatment will be capped after 6 doses.
15947770|NCT03281369|Drug|Tiragolumab|Tiragolumab: 600 mg administered by IV infusion on Day 1 of every 21 day cycle.
15947771|NCT03281369|Drug|5-Fluorouracil (5-FU)|5-FU 800 mg/m^2 administerd by IV infusion on Days 1-5 of each 21 day cycle.
15947772|NCT03281356|Behavioral|Intervention Group|Participants will receive a total of 8 text messages during a 4 week period.
15947773|NCT03281343|Behavioral|Motivational Interviewing & Patient Navigator|The specific content, structure, and implementation approach for MI-NAV will be guided by IDIs conducted during Phase 1 and Phase 2. Our initial plan is to deliver MI-NAV in two waves. The first wave will be aimed at promoting uptake of PrEP at the prison, through the use of motivational interviewing. The second wave will be aimed at linking at-risk women to community-based PrEP care upon release from incarceration, by utilizing a patient navigator approach.
15947774|NCT03281343|Behavioral|Standard of Care (SOC)|SOC will consist of a pamphlet regarding PrEP during incarceration, an offer of PrEP while incarcerated, and referral to community-based PrEP care upon release.
15947775|NCT03281330|Behavioral|auditory cues and music during walking|the effect of different conditions of auditory cueing and music on walking quality and perceived fatigue in persons with multiple sclerosis compared to healthy controls
15947776|NCT03281304|Drug|CP-690,500 5 mg|CP-690,550 5 mg tablet BID
15947777|NCT03281304|Drug|CP-690,550 10 mg|CP-690,550 10 mg tablet BID
15947778|NCT03281278|Other|standard treatment|standard medical treatment
15947779|NCT03281265|Other|standard treatment|
15947780|NCT03281239|Diagnostic Test|Laser doppler, blood tests, and holter ECG|"Diagnostic tests :
~laser doppler
~blood tests
~Holter ECG. No drug and no placebo were used in this arm."
15947781|NCT03281226|Drug|RIPE (2m) and RI (4m)|Rifampicin 150mg + isoniazid 75mg + pyrazinamide 400mg + ethambutol 275mg (oral combined fixed dose tablet according to the weight) for 2 months and a continuation with rifampicin 150mg and isoniazid 75mg (oral combined fixed dose tablet according to the weight) for 4 months
15947782|NCT03281226|Drug|RIPE+NAC (2m) and RI (4m)|Rifampicin 150 mg + isoniazid 75 mg + pyrazinamide 400 mg + ethambutol 275mg (oral combined fixed dose tablet according to the weight) plus oral N-acetylcysteine (NAC) 1200 mg (600mg twice daily) for 2 months and a continuation with rifampicin 150mg and isoniazid 75mg (oral combined fixed dose tablet according to the weight) for 4 months
15947783|NCT03281213|Other|Thoracotomy|
15947784|NCT03281200|Drug|L - Antineoplastic and immunomodulating agents|L - Antineoplastic and immunomodulating agents
15947785|NCT03281200|Drug|L01 - Antineoplastic agents|L01 - Antineoplastic agents
15947786|NCT03281200|Drug|L01X - Other antineoplastic agents|L01X - Other antineoplastic agents
15947787|NCT03281200|Drug|L01XE - Protein kinase inhibitors|L01XE - Protein kinase inhibitors
15947788|NCT03281200|Drug|L01XE31 - Nintedanib|L01XE31 - Nintedanib
15947789|NCT03281187|Drug|Nasotestt 5 mg|The 114 participants randomized to this arm must administer one packet of testosterone 5 mg nasal gel (Nasotestt) in each nostril 3 times a day for 60 days.
15947790|NCT03281187|Drug|Androgel 50 mg|The 114 participants randomized to this arm must administer one packet of testosterone 50 mg topic gel (Androgel) applied once daily to skin of shoulders for 60 days.
15947791|NCT03281187|Other|Nasotestt Placebo|The participants randomized to this arm must administer one packet of placebo testosterone nasal gel (Nasotestt Placebo) in each nostril 3 times a day in addition to an active drug for 60 days.
15947792|NCT03281187|Other|Androgel Placebo|The participants randomized to this arm must administer one packet of placebo testosterone topic gel (Androgel Placebo) applied once daily to skin of shoulders in addition to an active drug for 60 days.
15947823|NCT03280758|Behavioral|Muscle Strengthening exercises|Participants will be required to participate in resistance training 3 hours per week.
15947824|NCT03280745|Drug|Hypertonic saline|At admission to the ICU patients will receive 5ml/kg body weight of 7.3% NaCl by infusion pump over 60 minutes.
15947895|NCT03280290|Biological|blood|assessment pre-donation of hematopoietic stem cells (blood sample)
15947793|NCT03281161|Behavioral|Sun Safe Workplaces Program|A follow-up analysis of sun safe practices by employees and an economic evaluation of the SSW intervention was conducted with the work-sites who received occupational sun protection policy promotion materials in the prior trial. The analysis of sun safety practices of employees was done by preparing the protocols and measures for surveying employees and front-line supervisors by online and paper methods. The economic evaluation was a retrospective collection of cost information from the prior project ledgers and an in depth interview with the key contact manager at each work-site. No additional treatment was provided and the groups were evaluated based on their prior condition assignment.
15947794|NCT03281161|Behavioral|Attention Control|A follow-up analysis of sun safe practices by employees and an economic evaluation of the SSW intervention was conducted with the work-sites who received occupational sun protection practice promotion materials in the prior trial. The analysis of sun safety practices of employees was done by preparing the protocols and measures for surveying employees and front-line supervisors by online and paper methods. The economic evaluation was a retrospective collection of cost information from the prior project ledgers and an in depth interview with the key contact manager at each work-site. No additional treatment was provided and the groups were evaluated based on their prior condition assignment.
15947795|NCT03281148|Device|Computer guided implant insertion group|Implants will be immediately inserted in fresh extraction sockets using CAD/CAM guides
15947796|NCT03281148|Device|Free hand implant insertion group|Implants will be immediately inserted in fresh extraction sockets using free hand technique
15947797|NCT03281135|Other|HPV testing|Clusters randomly allocated to this arm of the study will be sensitized to be showed up in nearby health posts for self sampling with Evalyn brush for HPV testing.
15947798|NCT03281122|Drug|Placebo|Specified dose on specified days
15947799|NCT03281122|Drug|BMS-986224|Specified dose on specified days
15947800|NCT03281109|Diagnostic Test|diagnosis|diagnosis with ELISA
15947801|NCT03281096|Drug|Berberine hydrochloride|patients take the Berberine hydrochloride 300mg tablet by mouth, 2 times a day with 3 years.
15947802|NCT03281096|Drug|Placebo|pill manufactured to mmic Berberine hydrochloride 100mg tablet
15947803|NCT03281083|Drug|Levothyroxine Sodium|
15947804|NCT03281057|Behavioral|CRAFT|CRAFT is a counseling/therapist to concern significant others to get their loved one, with an alcohol use disorder, into treatment
15947805|NCT03281044|Drug|Fecal microbiota capsules|Patients will receive FMT capsules DE containing the fecal microbiota drug substance within a gelatin capsule shell. The drug substance is fecal microbiota from a single donor.
15947806|NCT03281044|Drug|Placebo oral capsule|The control condition is a placebo FMT capsule. The FMT placebo capsule is identical in appearance to active capsules, but does not contain human feces, the active pharmaceutical ingredient. Placebo capsules will contain an autoclaved solution of glycerol and saline, contained in an identical gelatin capsule as the active product, including the same enteric polymer coating
15947807|NCT03281031|Procedure|Additional MRI Examination|MRI will be performed using a short protocol within 6 hours from CT and with blinding from CT results
15947808|NCT03281018|Behavioral|Caregiver Accompaniment Time (CAT) + preoperative hypnosis session|The hypnosis session is performed by a nurse trained in medical hypnosis; this interview lasts approximately one hour and is carried out 5 to 15 days before the hospitalisation. During the hypnosis session, the patient is free to choose what issues she wants to address. The patient will then go from a state of ordinary consciousness to a modified state of consciousness. This state will allow her to activate her own resources to handle difficulties, especially anxiety. Using a post-hypnotic suggestion, the patient will be able to revisit her work at any time she needs
15947809|NCT03280979|Drug|rescue regimen|In the rescue regimen , we administer MTX in an eight-day treatment regimen consisting of four administrations of TX given at 1 mg/kg I.M. every other day with folinic acid 0.1 mg/kg I.M,. given on intervening days.
15947810|NCT03280979|Drug|high dose methotrxate|In the high dose MTX protocol, the patients will receive 100 mg/m2 intravenous (IV) MTX bolus followed by 200 mg/m2IV MTX infused over 12 hours followed by folinic acid
15947811|NCT03280953|Diagnostic Test|Assessing fluid responsiveness by PWTT value|PWTT value will be analysed to find the cutoff values compared by esophageal doppler and pulse pressure variation.
15947812|NCT03280927|Drug|Jublia®|Jublia® topical solution
15947813|NCT03280914|Device|Auto-CPAP|Automatic Continuous Positive Airway Pressure treatment is the first-line treatment of obstructive sleep apnea
15947814|NCT03280901|Other|HD, Magnetic Resonance Imaging (MRI) scans|HD, Magnetic Resonance Imaging (MRI) scans using a specifically designed unit able to perform MRI scanning during HD sessions
15947815|NCT03280875|Other|pedalling exercises|pedalling exercises on a bicycle ergometer
15947816|NCT03280862|Device|Implantation of a Cardiac Resynchronisation Therapy (CRT) pacing device with or without Implanted Cardioverter Defibrillator|Implantation of CRT-P/-D device
15947817|NCT03280849|Other|Implant of bilaminar chitosan scaffold|The patient underwent endoscopic endonasal transsphenoidal surgery for resection of the sellar lesion, under the direct visualization, the lesion appeared redish and soft with moderately bleeding, a sample was taken for pathology and the remaining is extracted without complications, then the scaffold is implanted in the site of the bone defect in the sphenoid sinus, due to its moldable nature, it was easily set, covering the entire extension of the defect, a fat graft was set in the sphenoid sinus covering the bilaminar chitosan membrane, then fibrin sealant was used for hemostatic control and a nasal packing was set in both nostrils for finalize the procedure.
15947818|NCT03280836|Behavioral|Exercise|"All participants randomized to the intervention group will be asked to keep an exercise log with the date, time, average heart rate obtained from a heart rate monitor, duration of workout and stretching, and any comments regarding the workout. Participants will be instructed to bring workout logs to infusion sessions for review. Participants will also wear a Polar Heart Rate monitor (US model RS400, Polar Electro Inc., Lake Success, NY) during exercise to monitor exercise intensity.
~The aerobic exercise intervention will work toward the target of 75 minutes physical activity per week at 60%-85% of baseline VO2max."
15947819|NCT03280810|Other|Movement group|Experimental group : patients with schizophrenia who realise psycho-corporal training once a week, during 1 hour and a half for a period of two months
15947820|NCT03280797|Procedure|Blood sample|2ml blood taken into TruCulture tube
15947821|NCT03280771|Combination Product|Hope Soap|HOPE SOAP© is a colourful, translucent bar of soap with a toy embedded in its centre.
15947825|NCT03280745|Drug|0.9% saline|At admission to the ICU patients will receive 5ml/kg body weight of 0.9% NaCl by infusion pump over 60 minutes.
15947826|NCT03280732|Device|Lung Ultrasound|A Mindray-DC-T6 ultrasound machine equipped with a linear probe with frequencies ranging from 7.5 to 12 MHz will be use. LUS examination will consist of both longitudinal and transversal sections according to the methodology described by Copetti and colleagues.
15947827|NCT03280719|Device|Prone Radiotherapy|Prone positioning for regional nodal irradiation using the crawl breast couch.
15947828|NCT03280719|Radiation|Acceleration|Accelerated irradiation in 5 fractions over 12 days with simultaneously integrated boost
15947829|NCT03280719|Device|Supine Radiotherapy|Supine positioning for regional nodal irradiation using breastboard.
15947830|NCT03280719|Radiation|Hypofractionation|Moderate hypofractionation in 15 fractions over 3 weeks with simultaneously integrated boost
15947831|NCT03280706|Dietary Supplement|Maltodextrin|Maltodextrin 50g in water 500ml
15947832|NCT03280706|Dietary Supplement|Orange Juice|Orange juice 480ml + 20ml of water
15947833|NCT03280706|Dietary Supplement|Coffee with milk|Coffee with milk (330 ml of milk + 220 of water)
15947834|NCT03280693|Diagnostic Test|Diagnostic test|Body balance was assessed using Berg Balance Scale (BBS), while BMD of the lumbar spine was measured by dual energy X-ray absorptiometry (DEXA) scan.
15947835|NCT03280680|Other|Female+male group sessions|Female and male group member received separate group session on sexual and reproductive health and rights, gender, violence against women and girls, consent and choice, conflict resolution etc. Each group received 13 sessions of 2 hours over 20 months. Community mobilization and service provision for sexual and reproductive and violence against women were also provided.
15947836|NCT03280680|Other|Female group sessions|Only female group member received separate group session on sexual and reproductive health and rights, gender, violence against women and girls, consent and choice, conflict resolution etc. Each group received 13 sessions of 2 hours over 20 months. Community mobilization and service provision for sexual and reproductive and violence against women were also provided.
15947837|NCT03280680|Other|No group sessions|Community mobilization and service provision for sexual and reproductive and violence against women were also provided.
15947838|NCT03280667|Drug|Pembrolizumab plus denosumab|Pembrolizumab 200 mg IV every 3 weeks plus denosumab 120 mg SC on day 1, 8, 22 and then every 3 weeks with daily oral calcium and vitamin D
15947839|NCT03280654|Other|overactive bladder|Association between groups and over active bladder symptoms
15947840|NCT03280641|Drug|Dabigatran Etexilate 110mg|Dabigatran Etexilate 110mg, BID
15947841|NCT03280641|Drug|Warfarin Sodium|Target INR:1.6-3.0
15947842|NCT03280628|Procedure|Absorbable Sutures|The patient's doctor will close the patient's laceration with absorbable sutures.
15947843|NCT03280628|Procedure|Steri-Strips|The patient's doctor will close the patient's laceration with Steri-Strips.
15947844|NCT03280628|Procedure|Dermabond|The patient's doctor will close the patient's laceration with Dermabond.
15947845|NCT03280615|Dietary Supplement|Omega 3 fatty acids|Omega 3 fatty acids will be provided in a dose of 3.7 g/day, that should be enough to rise red blood cell levels of eicosapentanoic and docosahexanoic acids
15947846|NCT03280615|Dietary Supplement|Corn oil|Corn oil will be the placebo comparator for omega 3 fatty acids supplement
15947847|NCT03280602|Procedure|Tension band wiring (TBW)|2 x K-wire fixation (1.6 mm) and wire cerclage.
15947848|NCT03280602|Procedure|Plate fixation|Olecranon fractures in this arm are fixed with Synthes´ VA-LCP Olecranon Plates 2.7/3.5.
15947849|NCT03280589|Other|Sheetali/Sheekari Pranayama|Most pranayama involves (1) sitting quietly, (2) deep breathing (completely filling and emptying the lungs, at a slow/comfortable pace, with awareness), and (3) a specific mouth, tongue, lip and/or body shape, theorized to enhance the effects of the practice. Practitioners of pranayama modulate the cycles of inspiration and expiration, in a way that is theorized to achieve influence over autonomic functions such as heart rate, heart rate variability (HRV), and baroreflex [6]. For example, the manipulation of the tongue and face during Sheetali and Sheetkari pranayama is intended to stimulate parasympathetic nervous system activity and inhibit the sympathetic nervous system.
15947850|NCT03280589|Other|Sitting Quietly|Participant breaths in their natural way with out instruction
15947851|NCT03280589|Other|Deep breathing|Participant is required to pay attention to each breath
15947860|NCT03280550|Drug|Omalizumab|Participants received omalizumab as a subcutaneous injection once every 2 weeks (q2w) or once every 4 weeks (q4w). The dose (from 75 mg up to 600 mg) and dosing frequency (q2w or q4w) was determined by serum total IgE level and body weight using the study-drug dosing table.
15947861|NCT03280550|Drug|Placebo|Participants received matching placebo as a subcutaneous injection once every 2 weeks or once every 4 weeks. The dose and dosing frequency was determined by serum total IgE level and body weight using the study-drug dosing table.
15947890|NCT03280316|Procedure|surgery|patients with SVMs receive surgery
15947891|NCT03280316|Procedure|sacral neuromodulation|sacral neuromodulation (SNM) with InterStimTM
15947862|NCT03280537|Drug|Omalizumab|Participants received omalizumab as a subcutaneous injection once every 2 weeks (q2w) or once every 4 weeks (q4w). The dose (from 75 mg up to 600 mg) and dosing frequency (q2w or q4w) was determined by serum total IgE level and body weight using the study-drug dosing table.
15947863|NCT03280537|Drug|Placebo|Participants received matching placebo as a subcutaneous injection once every 2 weeks or once every 4 weeks. The dose and dosing frequency was determined by serum total IgE level and body weight using the study-drug dosing table.
15947864|NCT03280524|Other|reflexology|
15947865|NCT03280524|Other|self-care guidelines with feet|
15947866|NCT03280511|Drug|PIPAC|PIPAC is performed during a standard laparoscopy with a capnoperitoneum of 12 mmHg. During PIPAC, oxaliplatin 92 mg/m2 in 150 ml dextrose will be intraperitoneally nebulized at a rate of 0.5 ml/s with a maximum pressure of 200 PSI. The intraperitoneal air will be evacuated after 30 minutes of simple diffusion
15947867|NCT03280498|Procedure|Intubation|elective surgeries under general anesthesia with endotracheal entubation formula or USG asisted
15947868|NCT03280485|Other|no intervention|no intervention validation of guidelines via database
15947869|NCT03280472|Behavioral|Cognitive Bias Modification|"CBM training. For those in the CBM condition, participants will complete a task. In this task, they will read ambiguous, two- to four-sentence social-related scenarios on the computer. The final word in the scenario will have a missing letter. Participants will type the missing letter. Participants will also be asked to answer a Yes/No comprehension question about the scenario. The missing letter will resolve the ambiguity of the scenario in a positive way, intended to train participants to have more positively-biased interpretations of ambiguous social information"
15947870|NCT03280472|Behavioral|Symptom tracking|Participants will track their symptoms
15947871|NCT03280459|Procedure|robot-assisted cystectomy|Removal of urinary bladder in oncologic or functional setting using a assistance of a operation robotic for laparoscopy
15947872|NCT03280446|Device|Intragen fractional radiofrequency with NeuViVa|The Transcutaneous Fractional Radiofrequency Device (TFRF) is a minimal risk device that is currently cleared by the FDA K142833.The device uses a non-invasive, transepithelial treatment probe to elevate epithelial tissue temperatures to 40-45 oC for the purpose of promoting tissue contracture. Real-time tissue impedance monitoring will be carried out using the treatment probe.
15947873|NCT03280433|Other|Aortic valve replacement|
15947874|NCT03280420|Procedure|Early catheter removal|"Patients will receive selective alpha blocker ( tamsulosin 0.4mg ) once daily and the catheter will be removed after 3 days.
~After catheter removal, patients will be allowed to void and will be discharged home who will have a successful void more than 200 cc of urine. Patients who will fail to void will be re-catheterized and will be prepared for prostatectomy."
15947875|NCT03280420|Procedure|Late catheter removal|"Patients will receive selective alpha blocker ( tamsulosin 0.4mg ) once daily and the catheter will be removed after 7 days.
~After catheter removal, patients will be allowed to void and will be discharged home who will have a successful void more than 200 cc of urine. Patients who will fail to void will be re-catheterized and will be prepared for prostatectomy."
15947876|NCT03280407|Drug|Capecitabine|Radio-chemotherapy with 50.4 Gy in 28 fractions to tumor and regional lymph nodes concomitantly with capecitabine 825 mg/m2 b.i.d
15947877|NCT03280407|Drug|FOLFOX regimen (oxaliplatin/leucovorin/5FU)|Six cycles: Oxaliplatin 85 mg/m2 day 1, leucovorin 400 mg/m2 day 1, 5FU 400 mg/m2 bolus day 1 and 5FU 2400 mg/ m2 over 46-48 hours day 1-3, repeated every two weeks.
15947878|NCT03280407|Drug|CAPOX (oxaliplatin/capecitabine)|Four cycles: Oxaliplatin 130 mg/m2 day 1 and capecitabine 1000 mg/m2 b.i.d. days 1-14, repeated every 3 weeks.
15947879|NCT03280394|Diagnostic Test|Liquid Biopsy|Assessing whether plasma cell free DNA improves the accuracy of early prediction of cure in mature B-cell tumor patients and whether it represents an accessible source of tumor DNA for the sensitive identification of genetic biomarkers that, at disease presentation, refine the diagnostic workup in mature B-cell tumor patients and, upon treatment, early identify the emergence of resistance mutations.
15947880|NCT03280381|Other|Nifty feeding cup|The 40 mL Nifty Feeding Cup features an extended reservoir off the lip of the cup that holds a small bolus of milk, ensuring efficient delivery of milk, is made of a durable, soft, silicone material that protects the infant's mouth from injury, has embossed measurements help with tracking volume and intake of milk, is ergonomically designed for frequent use and to enhance finger and wrist control of milk flow and is made from a quick-drying, ultraviolet radiation-resistant, durable, affordable silicone that can be boiled for sterilization. Mothers can directly express into the cup, reducing possible cross-contamination from other containers.
15947881|NCT03280381|Other|Generic medicine cup|The generic cup that will be used in this study is a small medicine cup 30 ml in size.Small medicine cups are manufactured by a variety of manufacturers and are commonly used in health facilities to feed breastmilk to infants who are having breastfeeding difficulties. The cups are generally translucent, calibrated with a variety of measurements including 2.5-30 mL.
15947882|NCT03280368|Other|Bloodtest|
15947883|NCT03280368|Other|Questionnaires|
15947884|NCT03280355|Behavioral|Singing training|"Each session will contain technical instruction in order to achieve better respiratory control and primary muscular strength, and with focus on techniques for efficient expiration. Sessions will also focus on musical content and interpretation as well as interaction, the social aspects and joy of singing together.
~Prior to the trial all singing teachers will participate in a 2 days' workshop, where they will be instructed in sufficient methodology and didactics, and will obtain profound knowledge about the disease pathology and related physiology."
15947885|NCT03280355|Behavioral|Physical Training|"Physical Training (golden standard training activity in pulmonary rehabilitation) - usual care - is the active comparator in the trial.
~The programme is based on the national guidelines for pulmonary rehabilitation, and consists of supervised warm-ups, aerobic exercises, workout (strength), and breathing exercises.
~Physical Training is conducted by the local physiotherapists in the local health centres."
15947886|NCT03280342|Drug|IR-TPM (Topamax)|XR-TPM (Trokendi XR)
15947887|NCT03280342|Drug|XR-TPM (Trokendi XR)|XR-TPM (Trokendi XR)
15947888|NCT03280329|Other|Generalized Music therapy|Patients will receive broadcasted music via speakers in their room from 7am to 11pm, from admission to discharge
15947889|NCT03280329|Other|Personalized Music therapy|Patients will receive music via earphones after specific music therapist advice, for 2 hours per day, from admission to discharge
15983807|NCT03009019|Drug|DFN-15 Active|
15947896|NCT03280277|Procedure|Contrast-enhanced Magnetic Resonance Imaging|Undergo ferumoxytol-enhanced MRI
15947897|NCT03280277|Drug|Ferumoxytol|Given IV
15947898|NCT03280264|Drug|KHK7580|oral administration
15947899|NCT03280251|Drug|Methylphenidate|Methylphenidate (capsules of Ritaline LP 10) encapsulated, 0,3 mg per kg per day during 6 weeks
15947900|NCT03280251|Drug|Placebo|Placebo, identical capsules to encapsulated MPH, number of capsules per day identical to MPH during 6 weeks
15947901|NCT03280251|Other|CogniPlus software|Structured cognitive training with CogniPlus software, twice per week during 6 weeks
15947902|NCT03280251|Other|Pseudo cognitive training|Pseudo cognitive training with 45 minutes documentary videos and 15 minutes quiz, twice per week during 6 weeks
15947903|NCT03280238|Diagnostic Test|Measurement of pupil dilation and analgesia nociception index|painful electrical stimuli of various intensities were administered to the subjects after which changes in pupil diameter and analgesia nociception index were measured
15947904|NCT03280225|Other|External facilitation|"Facilitation is an evidence-based implementation strategy to support sites that have difficulty implementing innovative programs. Facilitation is a multi-faceted process of interactive problem solving and support that occurs in the context of a recognized need for improvement and a supportive interpersonal relationship (Powell et al., 2015). Facilitation has been used nationally across VA to implement a number of different clinical interventions. The current project will examine this minimally intensive version of implementation facilitation, virtual external facilitation."
15947905|NCT03280212|Drug|Tranexamic Acid 500 MG|Tranexamic Acid 500mg oral tablets.
15947906|NCT03280199|Other|simulation types|Different types of simulation interfaces and image acquisitions
15947907|NCT03280186|Procedure|surgery|The minimally invasive surgical treatment methods and new techniques will be adopted such as spinal superselective angiography, preoperative embolization, intraoperative electrophysiological monitoring, intraoperative angiography, etc.
15947908|NCT03280173|Drug|tafamidis|bioavailability study
15947909|NCT03280160|Drug|Ibrutinib 140 MG Oral Capsule [Imbruvica]|"Ibrutinib will be administered orally 420 mg (3 x 140 mg capsules) once daily on a continuous schedule on an outpatient basis until disease progression or unacceptable toxicity.
~After 12 cycles of ibrutinib, patients that do not achieve a complete response (CR) will be treated with the combination of ibrutinib and ofatumumab. Patients in CR after 12 cycles of ibrutinib will continue with ibrutinib alone.
~Ofatumumab will be administered by IV infusion, 300mg on Day 1 and 1,000 mg on Day 8 of cycle 13, followed by 5 monthly infusions of 1,000 mg (Day 1 of subsequent 28-day cycles for cycles C14, C15, C16, C17, and C18).
~A treatment cycle will be defined as lasting 28 days"
15947910|NCT03280147|Drug|7-day course of antibiotics|"Subjects in the 7-day course of antibiotics arm of the study will receive no further antibiotics after randomization as they would have already received 7 days of sensitive antibiotics before randomization. The choice of antibiotics would be guided by the blood culture and sensitivity report. Thus, subjects in this arm of the study could get a variety of antibiotics, depending on the sensitivity reports. Hence, names of specific antibiotics and/or their brand names have not been mentioned."
15947911|NCT03280147|Drug|14-day course of antibiotics|"Subjects in the 14-day course of antibiotics arm of the study will receive 7 more days of antibiotics after randomization as they would have already received 7 days of sensitive antibiotics before randomization. The choice of antibiotics would be guided by the blood culture and sensitivity report. Thus, subjects in this arm of the study could get a variety of antibiotics, depending on the sensitivity reports. Hence, names of specific antibiotics and/or their brand names have not been mentioned."
15947912|NCT03280134|Procedure|axillary lymph node dissection (ALND)|If the patients had predictive nSLN+, need further axillary lymph node dissection.
15947913|NCT03280121|Device|EsophyX ZR transoral device|TIF
15947914|NCT03280108|Device|AcrySof IQ PanOptix Multifocal IOL|AcrySof IQ PanOptix Multifocal IOL Model TFNT00 for near, intermediate, and distance vision
15947915|NCT03280108|Device|AcrySof Monofocal IOL|AcrySof Monofocal IOL Model SN60AT for single vision
15947916|NCT03280095|Drug|co-codamol 15mg/500mg capsule|
15947917|NCT03280095|Drug|co-codamol 30mg/500mg tablet|
15947918|NCT03280082|Other|MUAC Program|All children admitted to the PB program will receive standard care according to the national Protocol and that of MSF, including preventive and therapeutic care at admission as well as hospital care in case of clinical complications. There will be no change in the Protocol for the hospital care to the CRENI (Center of Intensive Nutritional Rehabilitation). RUTF (Ready-to-Use therapeutic food) will be distributed on a weekly basis according to the dosage of RUTF in the national protocol.
15947919|NCT03280082|Other|Standard Program|All children admitted to the standard program will receive standard care according to national and MSF protocols, including preventive and therapeutic care on admission as well as hospital care in case of clinical complications. RUTF will be distributed on a weekly basis according to the dosage of RUTF in the national protocol.
15947920|NCT03280069|Device|THERMIeyes® 20 RF System|The masked evaluating physician will be blinded as to which eye is treated. The evaluation on all visits will be performed on both eyes by the masked physician who will not know which eye has been treated with the THERMIeyes® 20 RF System. The treating technician will be aware of the treated eye so as to ensure all treatments are performed to the same eye.
15947921|NCT03280056|Biological|NurOwn® (MSC-NTF cells)|Autologous transplantation of bone marrow derived mesenchymal stem cells propagated ex vivo and induced to secrete neurotrophic factors
15947922|NCT03280056|Other|Placebo|Placebo
15947923|NCT03280056|Other|Bone Marrow aspiration|Bone Marrow aspiration
15947924|NCT03280043|Procedure|Hematoma|Hematoma requiring return to operating room.
15947925|NCT03280030|Drug|Midostaurin|Midostaurin 50 mg [two 25 mg capsules] will be administered twice per day by mouth on day 8-21 during induction and consolidation phase; then continuously during continuation phase
15947926|NCT03280030|Drug|Placebo|Placebo two capsules will be administered twice per day by mouth on day 8-21 during induction and consolidation phase ; then continuously during continuation phase.
15947927|NCT03280017|Drug|Ketamine|intravenous ketamine 0.2 mg/kg/hr (concentration 1 mg/ml)
15947928|NCT03280017|Drug|Normal saline|normal saline infusion
15947929|NCT03280004|Drug|Moxifloxacin Hydrochloride and Sodium Chloride Injection|Moxifloxacin group will be given Moxifloxacin Hydrochloride and Sodium Chloride Injection and β-lactams group will be given β-lactam antibiotics for injection +/- Azithromycin for Injection.
15947933|NCT03279965|Diagnostic Test|MRI|MRI of lungs, paranasal sinuses and liver in addition to established clinical examinations (lung CT, pulmonary function testing)
15947934|NCT03279952|Drug|CNS Stimulant|Participants will be stabilized by any FDA approved CNS stimulant medication during open label trial.
15947935|NCT03279939|Device|OCT Angiography|OCT Angiography offers clinicians a non-invasive three-dimensional visualization of vasculature in the retina and choroid. The visualization of perfused vasculature in a three-dimensional layout, offers clinicians an aid in the identification of retinal and choroidal pathologies such as retinal ischemia, microaneurysms, retinal neovascularization and choroidal neovascular membranes.
15947936|NCT03279939|Device|Color Fundus Photography|Non-contact white light photography.
15947937|NCT03279939|Device|Fluorescein Angiography|An imaging procedure where dye is injected into a vein and images are taken of the back of the eye to visualize the perfusion of retinal vessels in two dimensional images.
15947938|NCT03279939|Device|Indocyaine Green Angiography|An imaging procedure where dye is injected into a vein and images are taken of the back of the eye to visualize the perfusion of choroidal vessels in two dimensional images.
15947939|NCT03279926|Behavioral|PLAY|Activity trackers + curriculum information
15947940|NCT03279926|Behavioral|PLAY Parents|Enhanced parental engagement
15947941|NCT03279926|Behavioral|PLAY Teachers|Enhanced teacher engagement with active living initiates for the teachers
15947942|NCT03279913|Device|EEG-neurofeedback training in association with TMS.|EEG-neurofeedback training in association with TMS.
15947943|NCT03279887|Diagnostic Test|Lung Ultrasound|
15947944|NCT03279874|Other|Interviews|Semi-structured one-on-one interviews
15947945|NCT03279861|Drug|Entresto|First line therapy in Entresto arm
15947946|NCT03279861|Drug|Valsartan|"First line therapy in usual meds arm"
15947947|NCT03279835|Other|Classic evaluation of neurocognitive functions|Symbol Digit Modalities Test (SDMT)
15947948|NCT03279835|Other|New evaluation of neurocognitive functions|Cognitive Speed Computerized Test (CSCT)
15947949|NCT03279822|Other|not any intervention|not any intervention
15947950|NCT03279809|Drug|Aspirin|Aspirin medication (100mg daily) after biliary stent insertion for malignant obstruction
15947951|NCT03279809|Drug|Placebo|Case with placebo medication for 6 months after stenting
15947952|NCT03279796|Biological|Autologous adipose-derived MSCs|The dose of adipose-derived mesenchymal stem cells was related to body weight, and 1 × 10 ^ 6 cells were a unit. One unit of adipose-derived mesenchymal stem cells was injected every 10 kg of body weight and injected once a week for three times.
15947953|NCT03279796|Drug|Compound betamethasone|1ml dexamethasone mixed with 0.5-2ml of saline to achieve the same injection volume with the cell suspension (which contains betamethasone dipropionate 5mg and betamethasone sodium phosphate 2mg) ), once a week for three times.
15947954|NCT03279783|Device|LCI (Linked color imaging)|Colonoscope withdrawal was performed in the right colon evaluating the mucosa using LCI (Linked color imaging)
15947955|NCT03279757|Drug|AHES 5 minutes|Topical application of AHES with 5 minutes application time After 5 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density
15947956|NCT03279757|Drug|AHES 15 minutes|Topical application of AHES with 15 minutes application time After 15 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density
15947957|NCT03279757|Drug|AHES 25 minutes|Topical application of AHES with 25 minutes application time After 25 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density
15947958|NCT03279757|Drug|LTC 5 minutes|Topical application of LTC with 5 minutes application time After 5 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density
15947959|NCT03279757|Drug|LTC 15 minutes|Topical application of LTC with 15 minutes application time After 15 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density
15947960|NCT03279757|Drug|LTC 25 minutes|Topical application of LTC with 25 minutes application time After 25 minutes: pain stimulus with the fractional CO2 laser, 50 mJ, 5% density
15947961|NCT03279757|Device|fractional CO2 laser, 50 mJ, 5% density|Pain stimulus with the fractional CO2 laser, 50 mJ, 5% density
15947962|NCT03279744|Drug|Radion™-pdt|The Radion™-pdt will be applied topically to the lesion. The Radion™-pdt applied dosage is about 0.1 mL/cm^2 and properly cover the entire lesion.
15947963|NCT03279731|Drug|Liraglutide (Saxenda) 6Mg/Ml Inj Pen 3Ml|subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). Matching the recommended dosage and administration guidelines of the FDA-approved labeling for the use of liraglutide (Saxenda), the medication will be initiated at 0.6 mg daily for 1 week, and then increased by 0.6 mg/day in weekly intervals until a dose of 3.0 mg/day is achieved.
15947964|NCT03279731|Drug|Placebo|subcutaneous injection, pre-filled, multi-dose pen that delivers doses of 0.6 mg, 1.2 mg, 1.8 mg, 2.4 mg, or 3 mg (6 mg/mL, 3 mL). It is designed to be identical to the pen used for liraglutide (Saxenda). Placebo product inactive ingredients: disodium phosphate dihydrate, 1.42 mg; propylene glycol, 14 mg; phenol, 5.5 mg; and water for injection
15947966|NCT03279705|Device|Water jet channel|The separate water jet channel was used for infusing water.
15947967|NCT03279705|Device|Accessory channel|The accessory channel was used for infusing and/or suctioning water
15947968|NCT03279692|Drug|Pembrolizumab|pembrolizumab binds to PD-1, an inhibitory signaling receptor expressed on the surface of activated T cells, and blocks the binding to and activation of PD-1 by its ligands, which results in the activation of T-cell-mediated immune responses against tumor cells
15947969|NCT03279679|Procedure|costoclavicular infraclavicular block|Infraclavicular brachial plexus block will be performed through new costoclavicular space approach under realtime ultrasound guidance with 0.5% ropivacaine
15947970|NCT03279679|Procedure|paracoracoid infraclavicular block|Infraclavicular brachial plexus block will be performed through traditional paracoracoid approach under realtime ultrasound guidance with 0.5% ropivacaine
15947971|NCT03279679|Device|Ultrasound|All the nerve blocks will be performed under realtime ultrasound guidance
15947972|NCT03279679|Drug|Ropivacaine|0.5% ropivacaine will be used for the brachial plexus block in both groups.
15947973|NCT03279666|Other|Tenaculum replacement|Tenaculum replacement during colposcopic biopsy
15948036|NCT03279237|Drug|5-Fluorouracil|May help shrink tumor before surgery.
15947974|NCT03279653|Procedure|SleeveGastrectomy|Preoperative enzyme test before and after sleeve gastrectomy. Sleeve Gastrectomy will be performed. Preoperative (in one month) and Postoperative (after 3 months) pancreatic enzyme sufficiency (with steatocrit or fecal elastase) will be compared.
15947975|NCT03279640|Device|rTMS on ipsilesional M1|
15947976|NCT03279640|Device|tDCS on contralesional M1|
15947977|NCT03279627|Other|Diabetes Management Questionnaire|Patients will be asked questions regarding their understanding of instructions for home diabetes management within 48 hours of hospital discharge. At 1 and 3 months, participants will be contacted to obtain information regarding ER visits or hospital readmissions.
15947978|NCT03279614|Drug|SOX|OXA：130mg/m2 ，iv drip for 180min d1, S-1 40-60mg p.o. bid d1-14, q3W
15947979|NCT03279601|Drug|Capecitabine, Dacarbazine|Capecitabine: 1000mg/m2 ，p.o. bid d1-14 q4W Dacarbazine: 200mg/m2 ，iv drip,d1-5 q4W
15947980|NCT03279601|Drug|Capecitabine, Temozolomide|Capecitabine: 1000mg/m2 ，p.o. bid d1-14 q4W, Temozolomide: 200mg/m2 ，p.o. bid d10-14 q4W,
15947981|NCT03279588|Diagnostic Test|Bedside Ultrasound|Patients presenting to the Emergency Department with abdominal pain suspected of acute diverticulitis are evaluated with standard care by an Emergency Physician (tutor); at the time the tutor requests an imaging test performed by Radiologist (CT scan or US scan), he notifies another physicians skilled in bedside abdominal US (ultrasonographer), who evaluates the patient and performs the US scan. Ultrasonographer after completation of US and knowing blood samples results fills in a standardized form reporting the diagnostic hypotesis, the need for additional work-up (if deemed necessary), and the disposition of the patient. The standardized form completed by the ultrasonographer will be compared with the actual management of the patient.
15947982|NCT03279575|Behavioral|Night Shift|Physicians in this arm of the trial will be asked to play Night Shift, an adventure video game, for two hours.
15947983|NCT03279575|Behavioral|Graveyard Shift|Physicians in this arm of the trial will be asked to play Graveyard Shift, a puzzle video game, for two hours.
15947984|NCT03279575|Behavioral|Educational program|Physicians in this arm of the trial will be asked to use myATLS, an app designed by the American College of Surgeons to serve as an adjunct to the ATLS course, and Trauma Life Support MCQ Review, an app designed to help students prepare for the ATLS exam. They will be asked to spend at least two hours on the combined tasks.
15947985|NCT03279575|Behavioral|Control|Physicians in this arm will serve as a no-contact control group.
15947986|NCT03279562|Drug|Nalmefene|Educational and behaviorally oriented drug counseling
15947987|NCT03279549|Procedure|Routine dressing change|Through regular dressing changes to clean the wound, reduce bacterial growth in the wound and protect the wound. In recent years, nano-silver ion gel and dressings are widely used in burns, which effectively reduced the risk of wound infection and beneficial for wound healing. This technique is widely used in clinic.
15947988|NCT03279549|Procedure|Limited debridement & Acellular dermal matrix dressing|"In the removal of necrotic dermis in the rather not deep principle, as far as possible not damage the normal dermal tissue and skin accessories. This could improve circulation of wounds and improve wound healing. The xenogeneic acellular dermal matrix dressing has a better protective effect on burn wound after debridement. After covering, the wound will remain alive for about two weeks, providing a good microenvironment for wound repair."
15947989|NCT03279549|Procedure|Limited debridement & Epidermal cell spraying|"In the removal of necrotic dermis in the rather not deep principle, as far as possible not damage the normal dermal tissue and skin accessories. This could improve circulation of wounds and improve wound healing. Epidermal cell spraying technology is a brand new method to rapidly collect epidermal cells from patients themselves and then used on their wounds. The recipient site is 40-80 times than the donor site."
15947990|NCT03279549|Procedure|Limited debridement & Basic fibroblast growth factor|"In the removal of necrotic dermis in the rather not deep principle, as far as possible not damage the normal dermal tissue and skin accessories. This could improve circulation of wounds and improve wound healing. BFGF is a kind of polypeptide capable of promoting the growth of fibroblasts, and it also promotes the proliferation, differentiation and migration of epidermal cells. Studies have shown that bFGF could significantly improve the healing of burn wounds."
15947991|NCT03279536|Combination Product|Oral lactoferrin|Oral lactoferrin 120 mg twice /day and it's based on fast dissolving through direct swallowing per oral route with fruits flavor taste.
15947992|NCT03279536|Combination Product|TDI of LMW iron dextran|Total Dose Infusion of LMW iron dextran up to 20mg/kg body weight is infused intravenously
15947993|NCT03279523|Drug|F 18 T807|Participants will receive a single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807. For those who cannot tolerate the full exam, participants will receive single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807.
15947994|NCT03279510|Device|hearing aids|Subjects are fit with hearing aids.
15947995|NCT03279497|Behavioral|Health game|Participants allocated to the Health game intervention group get to use the health game during the four week intervention period and participants are allowed to use it on their free time.
15947996|NCT03279497|Behavioral|Sport and fitness application|Participants allocated to the Sport and fitness application intervention group get to use the sport and fitness application during the four week intervention period and participants are allowed to use it on their free time.
15947997|NCT03279484|Device|NAVIGO 4LV lead implant|All patients will be attempted to implant or implanted with NAVIGO 4LV lead
15947998|NCT03279471|Drug|Sertraline|Participants start at 12.5 mg and are increased by 12.5/day every two weeks for 14-16 weeks based on their tolerability to the medication. Dosing is capped at 125mg/day.
15947999|NCT03279471|Behavioral|CBT/BIACA|Participants receive 16 weeks of BIACA therapy.
15948000|NCT03279471|Drug|Placebo|Participants are given a placebo capsule with an administration schedule matching that of the sertraline subjects.
15948001|NCT03279458|Device|Linshom Respiratory Monitoring Device|Volunteers will breathe through a continuous positive airway pressure (CPAP) face mask fitted wth the Linshom device. The volunteers will be instructed to breathe normal through the CPAP mask on room air. The excursions of the thermistor tracings (from valley to peak) will be recorded by the Linshom device and displayed continuously on a laptop monitor in a waveform. The tidal volume will also be measured by the ventilator and the data downloaded in a Compact Flash card.
15948002|NCT03279445|Genetic|Genetic testing|Two tubes of blood samples for genetic testing.
15948037|NCT03279237|Drug|Paclitaxel|Paclitaxel may stop cancer cells from growing and spreading.
15948003|NCT03279419|Diagnostic Test|Thermal imaging|Use of thermal imaging camera to capture images of peripheral vasculature (hands).
15948004|NCT03279406|Device|Percutaneous Left Atrial Appendage Occlusion|Percutaneous left atrial appendage occlusion in routine care for patients with atrial fibrillation
15948005|NCT03279393|Drug|fluorodeoxyglucose (FDG)-PET/MRI|Innovative PET combined with magnetic resonance imaging (PET/MRI) to simultaneously study the hematopoietic system, the artery wall, and the brain's fear system, which comprises the amygdala and anterior cingulate cortex (ACC)
15948006|NCT03279380|Other|SNP|Screening 150 endurance, 150 power athletes, and 200 healthy control individuals for genetic variant associated to sport performance.
15948007|NCT03279380|Other|High Intensity Interval Training (HIIT)|The subgroup (n = 40) of the athletes will participate in the acute exercises (HIIT Training). In order to investigate the acute effects of the exercise the concentration of circulating myokines will be measured (before, post-exercise and 2 h post-exercise). All participants will visit the laboratory at least three times, scheduled 96 h apart. Exercise will be carried out on the cycling ergometer with simultaneous monitoring of physiological responses. Participants will be asked to follow the prescribed diet regime and not to perform any physical activities / trainings the day before measurements. Baseline measurements will include the V̇o 2 peak test. Then the participants will be randomly divided into two groups. The specific acute exercises will be accomplish in the next two visits.
15948008|NCT03279380|Other|Low Intensity Continuous Training|The subgroup (n = 40) of the athletes will participate in the acute exercises (LIT Continuous Training). In order to investigate the acute effects of the exercise the concentration of circulating myokines will be measured (before, post-exercise and 2 h post-exercise). All participants will visit the laboratory three times, scheduled 96 h apart. Exercise will be carried out on the cycling ergometer with simultaneous monitoring of physiological responses. Participants will be asked to follow the prescribed diet regime and not to perform any physical activities / trainings the day before measurements. Baseline measurements will include the V̇o 2 peak test. Then the participants will be randomly divided into two groups. The specific acute exercises will be accomplish in the next two visits.
15948009|NCT03279367|Diagnostic Test|Objective speech response detection|Changes in brain activity when a speech stimulus is presented will be measured using electro-encephalography (EEG)
15948010|NCT03279354|Behavioral|Family Move app intervention|All the recruited parent-child pairs will be randomized after baseline assessment by an independent statistician using computer randomization tool to either the FAMILY MOVE app intervention group or the HK FitNuts app control group with a 1:1 allocation ratio. Although both groups receive a stand-alone app, the apps have distinct design features: use of competition and point elements (FAMILY MOVE app) or use of traditional demonstration elements (HK FitNuts app). After both groups have completed the 8-week intervention study and follow up measurements at 1 month, 6 months and 12 months after intervention, the control group will receive the same FAMILY MOVE app. Outcome assessments will be conducted by a trained interviewer blinded to the subject group allocation.
15948011|NCT03279354|Behavioral|"HK FitNuts app intervention"|"The parent-child pairs in the control group will be given a link to download the HK FitNuts app which was developed by Hong Kong Association of Sports Medicine and Sports Science, Department of Orthopaedics & Traumatology of the Chinese University of Hong Kong and Hong Kong Dietitians Association to promote healthy lifestyle in Hong Kong. The app includes short video clips demonstrating basic individual exercise moves and provides other textual information related to PA. However, it does not have push notification function. In order to ensure that the intervention and control group will receive equal attention from our research team, we shall send a text about HK FitNuts and general exercise information to participants in the control group three times per week. Same as participants in the intervention group, the control group will also be asked to provide their weekly app usage and PA pattern by completing an online log at the end of each intervention week."
15948012|NCT03279341|Drug|polyethylene glycol|osmotic laxative
15948013|NCT03279341|Drug|Bisacodyl|stimulant laxative
15948014|NCT03279341|Drug|Prucalopride|prokinetic
15948015|NCT03279328|Drug|Topical Steroid Ointment|Based on randomization, the subject will either apply Topical Steroid Ointment, Vaseline or skin barrier repair moisturizer to one side of the face for seven days.
15948016|NCT03279328|Other|Vaseline|Based on randomization, the subject will either apply Topical Steroid Ointment, Vaseline or skin barrier repair moisturizer to one side of the face for seven days.
15948017|NCT03279328|Drug|Skin Barrier Moisturier|Based on randomization, the subject will either apply Topical Steroid Ointment, Vaseline or skin barrier repair moisturizer to one side of the face for seven days.
15948018|NCT03279315|Dietary Supplement|iodized table salt, non-iodized table salt|During the first 3 weeks, the diet was provided with non-iodized salt, while the diet with iodized salt was only offered in the last week.
15948019|NCT03279302|Drug|Glepaglutide|Solution for injection
15948020|NCT03279289|Drug|Aflibercept|4 mg/kg administered intravenous infusion on day 1
15948021|NCT03279289|Drug|Irinotecan|180 mg/m2 intravenous infusion
15948022|NCT03279289|Drug|folinic acid (dl racemic)|400 mg/m2 intravenous infusion
15948023|NCT03279289|Drug|5Fluorouracil|400 mg/m2 intravenous bolus
15948024|NCT03279289|Drug|5-FU|2400 mg/m2 continuous intravenous infusion over 46 hours
15948025|NCT03279276|Procedure|Total Hip Arthroplasty|"The usual procedures of the department: Moore incision and insertion of uncemented joints (exceed with vitamin E enriched polyethylene liner and 32 or 36 mm head). Cyclokaprone is administered peroperatively (bleeding-reducing), antibiotics and thrombosis prophylaxis. Follow the usual rehabilitation regimes, fast track, incl. Use of crutches and must support within the pain limit, possibly with crutches the first 4 weeks after surgery, then full load.
~By default, postoperative X-ray and RSA recordings will be performed on the 1st or 2nd postoperative day. The surgery will be performed by specialist physicians in orthopedic surgery associated with the hip arthroplasty sector."
15948026|NCT03279263|Drug|MLR-1023|MLR-1023 Tablets
15948027|NCT03279263|Other|Placebo|Matching Placebo Tablets
15948028|NCT03279250|Drug|Abiraterone Acetate|Given PO
15948029|NCT03279250|Drug|Apalutamide|Given PO
15948030|NCT03279250|Biological|Gonadotropin-releasing Hormone Analog|Given IM
15948031|NCT03279250|Drug|Prednisone|Given PO
15948032|NCT03279250|Procedure|Radical Prostatectomy|Undergo radical prostatectomy
15948033|NCT03279237|Drug|Irinotecan|May help shrink tumor before surgery.
15948039|NCT03279237|Drug|Carboplatin|Carboplatin may stop cancer cells from growing.
15948040|NCT03279224|Biological|Allogenic FMT|"Fifty (50) g of screened donor feces will be weighed and homogenized with 30 mL of sterile 0.9 N NaCl + 10% glycerol using a sterile 330 micron micro-filter-separated double-compartment polyethylene bag in the Stomacher® Paddle Blender.
~2.The volume of fecal filtrate corresponding to fifty (50) g of donor stools will be transferred into a 50 mL Falcon tube with screw top and frozen at -80oC.
~3. For colonoscopy administration, three (3) Falcon tubes of thawed FMT concentrated will be diluted to a total volume of 300 mL with 0.9N NaCl and will be transported to the endoscopy suite. In the endoscopy suite, the FMT product will be packaged into 6 x 50 ml syringes for patient delivery by colonoscopy."
15948041|NCT03279224|Biological|Autologous FMT|"1. Fifty (50) g of the participant's feces will be weighed and homogenized with 30 mL of sterile 0.9 N NaCl + 10% glycerol using a sterile 330 micron micro-filter-separated double-compartment polyethylene bag in the Stomacher® Paddle Blender.
~3.The volume of fecal filtrate corresponding to fifty (50) g of participant's stools will be transferred into a 50 mL Falcon tube with screw top and frozen at -80oC.
~3. For colonoscopy administration, three (3) Falcon tubes of thawed FMT concentrated will be diluted to a total volume of 300 mL with 0.9N NaCl and will be transported to the endoscopy suite. In the endoscopy suite, the FMT product will be packaged into 6 x 50 ml syringes for patient delivery by colonoscopy."
15948042|NCT03279211|Other|Whey Protein Isolate 894 Fonterra|30 g of protein powder diluted in water
15948043|NCT03279211|Other|Zein Sigma-Aldrich W555025|30 g of protein powder diluted in water
15948044|NCT03279211|Other|Protein-free test-meal|No protein included in the drink made of water and flavour/sugar
15948045|NCT03279198|Behavioral|TIWeb|Intervention: TIWeb program is interactive and tailored to the participant's individual beliefs and demographics. Individuals receiving the TIWeb will be given information that allows them to call and receive an FOBT kit in the mail or schedule an appropriate CRC test and/or mammogram.
15948046|NCT03279198|Behavioral|CSC|Intervention: CSC - a telephone counseling call during which the participant is given the opportunity to complete CRC screening (FOBT or a colonoscopy) and/or mammography screening.The CSC included tailored counseling as well as the ability to schedule BC and CRC screening tests.
15948047|NCT03279198|Behavioral|UC|Intervention: The usual care group received usual care that varies dependent upon the practice setting.
15948048|NCT03279198|Behavioral|TIWeb+CSC|Intervention: TIWeb + CSC ((Tailored web intervetion+Cancer screening) group receive a mailed TIWeb, which is followed in four weeks by a CSC with the same opportunity to receive FOBT kits or schedule a colonoscopy and/or mammogram. The nurse counselor, knowing the participant is a good candidate for screening tests, will be trained to schedule CRC or BC screening appointments or to mail FOBT kits to individuals in the intervention groups even if they have not had a recent clinic visit.
15948049|NCT03279172|Procedure|direct laryngoscope|procedure entubatıon
15948050|NCT03279172|Procedure|videolaryngoscope|
15948051|NCT03279159|Other|Jaluronius CS cream short term evaluation|Short term evaluation to investigate the hydrating activity of a single application of the study product on the forearms (volar surface) after repeated stripping procedure,measured immediately after stripping execution (T0i), 1,8 and 24 hour/s after product application (T1h, T8h and T24h).
15948052|NCT03279159|Other|Jaluronius CS cream long term evaluation|Long term evaluation to investigate the hydrating activity of the repeated application of the study product on the face (twice a day, for an uninterrupted period of 8 weeks), measured at basal visit (T0) and after 4 and 8 week-treatment (T4, T8)
15948053|NCT03279146|Drug|Tenofovir exalidex (TXL)|Oral formulations
15948054|NCT03279133|Drug|Ledipasvir 90mg/Sofosubvir 400mg|Ledipasvir 90mg/Sofosubvir 400mg (LDV/SOF) FDC is to be administered once daily with or without food for12 weeks.
15948055|NCT03279120|Drug|TFV/LNG IVR|Used for 90 days (Continuous or Interrupted)
15948056|NCT03279120|Drug|Placebo|Used for 90 days (Continuous or Interrupted)
15948057|NCT03279107|Other|Soluble corn fiber|soluble corn fiber
15948058|NCT03279107|Other|maltodextrin|maltodextrin
15948059|NCT03279094|Biological|Hematopoietic stem cell transplantation|Haploidentical stem cell transplantation with pre-transplant immunosuppressive therapy
15948060|NCT03279081|Drug|Cx601|Cx601 eASCs intralesional injection.
15948061|NCT03279081|Other|Placebo|Cx601 placebo-matching eASCs intralesional injection.
15948062|NCT03279068|Other|Teaching and EFM Paper|Data will be collected for patients receiving EFM without pattern interpretation as the first phase of the study, as this is the current practice at Ayder Hospital. Then, the second phase will involve a week of teaching sessions regarding interpretation and management of EFM as per ACOG and FIGO guidelines. For the third phase of this study, paper will be provided for the use of EFM with pattern interpretation for all patients receiving EFM.
15948063|NCT03279055|Behavioral|SHUTi|Sleep Healthy Using the Internet (SHUTi) is a publicly available insomnia intervention program. It focuses on 5 treatment components that form the core of CBT-I: sleep restriction, stimulus control, cognitive restructuring, sleep behaviors, and relapse prevention.
15948064|NCT03279042|Procedure|Flapless corticotomy surgical intervention will be conducted|Piezocision will be used to perform the procedure
15948065|NCT03279042|Procedure|Traditional corticotomy|Here the surgery involves elevation of flaps and then conducting the surgical intervention using piezo-surgery cutting saws.
15948066|NCT03279029|Biological|blood samples|blood samples
15948067|NCT03279029|Biological|biopsy|biopsy of aortic valve
15948068|NCT03279003|Device|LED light|An exposure to LED light will be carried out twice a week until improvement, maximum 8 weeks.
15948069|NCT03278990|Behavioral|Value Affirmation and Future Selves Combination|Following the questionnaire, participants will complete a 10- to 15-minute writing exercise. In the control condition, they will be given a list of values, select two that are least important to them, then write about why those values might be important to others. Next, they will write a short letter to themselves in 2 weeks. In the treatment condition, they will be given a list of values, select two that are important to them, then write for about why those values are important to them and how they have played a role in their life. They will then write a short letter to themselves twenty years in the future.
15948070|NCT03278990|Behavioral|Control writing exercise|In this sham comparator, participants will also write, however, the content of the writing exercise is different. Participants write for five minutes about what they did that day. Next, for five minutes, they write a letter to themselves next week.
15948071|NCT03278977|Biological|Blood sample for specific analyzes|"Standard management of ALTE
~Hospitalization in pediatric intensive care unit or pediatric emergencies
~Etiologic research
~Blood volume, 2.5mL in PaxGene® tube, for specific analyzes (M2R, AchE)"
15948072|NCT03278964|Procedure|Orbital decompression|
15948073|NCT03278951|Behavioral|Video Conferencing Group|
15948074|NCT03278951|Behavioral|In Person Group|
15948075|NCT03278938|Drug|bupropion|FDA approved drug for treating depression
15948076|NCT03278938|Drug|citalopram|FDA approved treatment for depression
15948077|NCT03278925|Drug|Defined Green Tea Catechin Extract|Given PO
15948078|NCT03278925|Other|Laboratory Biomarker Analysis|Correlative studies
15948079|NCT03278925|Other|Pharmacological Study|Correlative studies
15948080|NCT03278925|Other|Questionnaire Administration|Ancillary studies
15948081|NCT03278886|Drug|Low dose naltrexone|4.5 mg of low dose naltrexone taken once daily for 8 weeks
15948082|NCT03278886|Drug|Nalmefene|18 mg of nalmefene taken once daily for 8 weeks
15948083|NCT03278873|Biological|either AAV - CNGB3 or AAV - CNGA3|Comparison of different dosages of either AAV - CNGB3 or AAV - CNGA3
15948084|NCT03278860|Drug|intranasal oxytocin|24 IU of oxytocin nasal spray will be applied to each subject.
15948085|NCT03278860|Drug|intranasal placebo|an identical amount of placebo nasal spray will be applied to each subject.
15948086|NCT03278860|Drug|intranasal oxytocin|24 IU of oxytocin nasal spray will be applied to each subject.
15948087|NCT03278860|Drug|intranasal placebo|an identical amount of placebo nasal spray will be applied to each subject.
15948088|NCT03278847|Dietary Supplement|Received enteral (milk) feeds during therapeutic hypothermia|"In the enteral component of nutrition, the health technology to be assessed is the gradual introduction of enteral (milk) feeds during therapeutic hypothermia:
~Included in this is any type of milk (e.g. expressed maternal breast milk, expressed donor breast milk and artificial formula)
~This health technology includes different routes of administering enteral feeds such as nasogastric tube (gavage feeding) and bottle
~This health technology also includes different rates of increasing enteral feeds (for example by 15ml/kg/day, by 30ml/kg/day or faster)"
15948089|NCT03278847|Dietary Supplement|Enteral (milk) feeds withheld during therapeutic hypothermia|Withholding enteral feeds (keeping a baby nil per os) for the duration of hypothermia.
15948090|NCT03278847|Dietary Supplement|Received parenteral nutrition during therapeutic hypothermia|"In the parenteral component, the health technology being assessed is administration of parenteral nutrition during therapeutic hypothermia:
~Included in this are different compositions of parenteral nutrition (for example standard, pre-prepared bags of nutrition and individually tailored parenteral nutrition)
~This health technology includes different routes of administration of parenteral nutrition such as via a peripheral intravenous cannula, percutaneous central venous catheter ('long line') or umbilical venous catheter.
~This health technology also includes different volumes of parenteral nutrition (e.g. 40ml/kg/day, 60ml/kg/day or greater)."
15948091|NCT03278847|Dietary Supplement|Did not receive parenteral nutrition during therapeutic hypothermia|Received standard intravenous fluids (10% dextrose with additional electrolytes added where required) for the duration of hypothermia.
15948092|NCT03278834|Device|Neuromuscular muscle stimulation machine- Strength Setting|Muscle stimulation to strength skeletal muscle
15948093|NCT03278834|Device|Neuromuscular muscle stimulation machine - TENS Setting|Muscle stimulation to mimic the intervention but without the strength gains.
15948096|NCT03278808|Drug|Chloroquine-Azithromycin (CQ/AZ)|Chloroquine-Azithromycin (CQ/AZ); Chloroquine (CQ) 300mg and 2g of azithromycin (AZ) given orally
15948097|NCT03278808|Drug|Chloroquine (CQ)|Chloroquine (CQ); 300 mg of CQ only given orally
15948098|NCT03278808|Drug|atovaquone-proguanil (Malarone®)|All subjects will participate in the Controlled Human Malaria Infection (CHMI) and will be required to stay at a hotel for evaluation for a maximum of 14 nights starting 7 days after the challenge. A standard dose of atovaquone-proguanil (Malarone®) will be administered to all symptomatic parasitemic subjects under directly observed treatment.
15948099|NCT03278795|Procedure|pressure support ventilation mode|PSV is the sole mode of mechanical ventilation and will be used as a weaning mode in mechanically ventilated chronic obstructive pulmonary disease patients,In PSV weaning group , PS(pressure support) will be adjusted at 8 cmH2O until 2-h successful spontaneous breathing trial parameters according to ERS(European Respiratory Society) guidelines will be achieved and then patient will ex-tubated.
15948100|NCT03278795|Procedure|volume support ventilation mode|"VSV mode could be viewed as PRVC for spontaneous breathing as it delivers a variable pressure to meet a target VT. VSV will be used as a weaning mode in mechanically ventilated chronic obstructive pulmonary disease patients,In VSV weaning group ,VT(tidal volume ) will be adjusted at 6 ml/ Kg until 2-h successful spontaneous breathing trial parameters according to ERS guidelines will be achieved and then patient will ex-tubated."
15948101|NCT03278782|Biological|Pembrolizumab|Given IV
15948102|NCT03278782|Drug|Romidepsin|Given IV
15948103|NCT03278769|Procedure|Lung protective ventilator settings|Positive end-expiratory pressure 12, Tidal volume 6 milliliter/kilogram predicted body weight
15948104|NCT03278756|Behavioral|Cognitive control training|10 sessions of an adaptive paced auditory serial addition task, each lasting 15 minutes, over the course of two weeks.
15948105|NCT03278756|Behavioral|Active control training|10 sessions of an low cognitive load task, each lasting 15 minutes, over the course of two weeks.
15948106|NCT03278743|Other|Cognitive performance and cognitive decline|Assess the global and domain specific (memory, speed and attention) cognitive function at baseline and over 5 years in the high vs. low/moderate tea consumption groups
15948107|NCT03278730|Drug|Para-Tyrosine supplementation|Patients will recieve the study drug during their stay at the ICU, but for a maximum of 7 days. The study drug is 3x2 gramms of para-Tyrosine, which will be dispensed and administered in a form of oral suspension via a nasogastric tube.
15948146|NCT03278444|Drug|Trimetazidine hydrochloride|Trimetazidine hydrochloride tablets 20mg/tablet, 40mg, twice a day.
15948108|NCT03278730|Drug|Placebo solution|Patients will recieveplacebo during their stay at the ICU, but for a maximum of 7 days. The study drug is 3x2 gramms of placebo, which will be dispensed and administered in a form of oral suspension via a nasogastric tube.
15948111|NCT03278704|Other|RE only|8 weeks of supervised training. Three times weekly with no more than two non-consecutive days without exercise.
15948112|NCT03278704|Other|RE + HIIT|8 weeks of supervised training. Three times weekly with no more than two non-consecutive days without exercise. Concurrent training: RE followed by HIIT within the same session.
15948113|NCT03278691|Drug|Saline|1 ml saline IV Q6H
15948114|NCT03278691|Drug|Ketorolac|15 mg (15 mg/ml) IV Q6H
15948115|NCT03278665|Drug|4SC-202 in combination with Pembrolizumab|4SC-202 in combination with Pembrolizumab
15948116|NCT03278652|Other|Consumption of drugs for analgesic use|"Regular assessment of pain
~Drug data will be collected (name, dosage, route of administration, time of delivery)"
15948117|NCT03278639|Behavioral|Rhythmic Auditory Stimulation|Training will be directed to ameliorate gait and balance
15948118|NCT03278639|Behavioral|Kinesiology|Training will be directed to ameliorate gait and balance
15948119|NCT03278626|Drug|Nivolimumab+Carboplatin/paclitaxel+Radiation|In the phase I portion of the study, up to six patients will be treated (radiation will be 50.4 Gy (1.8 Gy/fraction × 28 fractions)) and then observed for 28 days (following last day of treatment (Day 64)).
15948120|NCT03278613|Device|ES-130|"The ES-130 device will be used for the indication of Posterior Tibial Nerve Stimulation for the treatment of fecal incontinence using the FDA-approved protocol for treatment of urge urinary incontinence (UUI) in the PFDN NOTABLe study. There is no PTNS device cleared by the FDA for the indication of FI treatment; therefore, this is considered an investigational device."
15948121|NCT03278600|Genetic|tissue-of-origin (ORIGIN-PanCA○R) profiling|90-gene assay to predict the primary tumor site
15948122|NCT03278587|Other|Community-based screening program|In communities randomized to receive the screening program, all adults aged 50 and older will be eligible to receive screening for ocular disease. Screening assessments include visual acuity, refraction, intra-ocular pressure, fundus photography, and anterior segment photography. Participants meeting criteria for referral based on screening assessments will be referred to the nearest eye care center or eye hospital for further evaluation.
15948123|NCT03278587|Other|Cataract camp program|In communities randomized to receive the cataract camp program, all adults aged 50 and older will be eligible to participate in a routine cataract camp run by Bharatpur Eye Hospital. Trained ophthalmic personnel and assistants will perform case detection for cataract via visual acuity, pen light exam, and indirect ophthalmoscope exam per Bharatpur Eye Hospital's standard cataract camp program. Participants with cataracts will be referred to the nearest eye care center or eye hospital for further evaluation.
15948124|NCT03278587|Other|Community health worker program|In communities randomized to receive the community health worker program, all adults aged 50 and older will be eligible to participate. Existing community health workers will be trained to perform case detection for cataract via visual acuity assessment. Participants with cataracts will be referred to the nearest eye care center or eye hospital for further evaluation.
15948125|NCT03278574|Procedure|Mitral valve repair|Mitral valve repair with standard technique: resection of prolapsed leaflet and/or artificial neochordae implantation
15948126|NCT03278574|Device|Ring annuloplasty with posterior band|Mitral valve annuloplasty using Cardiamed (Penza, Russia) flexible posterior annuloplasty band
15948127|NCT03278574|Device|Ring annuloplasty with complete ring|Mitral valve annuloplasty using Cardiamed (Penza, Russia) complete semirigid ring
15948128|NCT03278561|Procedure|Sputum induction|Sputum induction according to the ERS protocol
15948129|NCT03278561|Procedure|Blood sample|A blood sample of 100ml will be taken.
15948130|NCT03278548|Drug|Volulyte 6%|Solution for infusion
15948131|NCT03278548|Drug|Ionolyte|Solution for infusion
15948132|NCT03278535|Diagnostic Test|CAREN-based gait analysis|subjects only walk at CAREN at different speed
15948133|NCT03278522|Drug|Ramosetron|Intravenous ramosetron 0.6mg is given to the patients at the induction of anesthesia, or at the end of surgery
15948134|NCT03278509|Drug|Metoprolol Succinate|Eligible patients randomized to active treatment will receive long-term oral beta-blockade (metoprolol succinate or bisoprolol).
15948135|NCT03278509|Drug|Bisoprolol|Please see the section above.
15948136|NCT03278496|Behavioral|Recovery Housing plus Counseling|Participants receive 3 months of abstinence-contingent program-supported rent payment in community recovery housing. They also receive intensive outpatient counseling (both individual and group) focused on relapse prevention skills training, goal setting, employment seeking and recreational activities.
15948137|NCT03278496|Behavioral|Usual Care Referral|Participants are referred to an outpatient program of their choosing with an appointment made for them.
15948138|NCT03278496|Behavioral|Recovery Housing Only|Participant may receive up to 3 months of abstinence-contingent rent payment in community recovery housing but is not invited to participate in intensive counseling.
15948139|NCT03278483|Drug|Isoniazid 300 mg Oral Tablet|Isoniazid tablets 300mg daily plus pyridoxine 50mg daily
15948140|NCT03278483|Drug|Rifampin 600 mg Oral Tablet|Rifampin capsules 600mg daily
15948141|NCT03278470|Drug|HL237|Experimental
15948142|NCT03278470|Drug|Placebo Oral Tablet|placebo with same properties except for active ingredient
15948143|NCT03278457|Diagnostic Test|Positron Emission Tomography|Positron Emission Tomography
15948144|NCT03278444|Other|Basic drugs therapy of HCC|Basic drugs include: 1. Molecular targeted drugs for HCC：apatinib; 2. Antiviral drugs (ETV or TDF) should be given to patients who were infected with HBV or HCV; 3. Patients with liver dysfunction should be treated with conventional hepatoprotective agents drugs (including glycyrrhizin, reduced glutathione, vitamin C，etc); 4. Patients with ascites symptoms should be treated with furosemide and spironolactone according to the urine volume, and they also should be treated with proton pump inhibitors in the prevention of gastrointestinal bleeding; 5. Other basic diseases were treated routinely.
15948145|NCT03278444|Drug|Arginine hydrochloride|Arginine hydrochloride injection 5g/dose; 40g/d; ivgtt; sustained medication for 24 days; drug withdrawal for 4 days.
15948147|NCT03278431|Drug|Albendazole|Albendazole (400 mg) from Janssen, donated by the World Health Organization
15948148|NCT03278431|Drug|Pyrantel Pamoate|Pyrantel pamoate (20 mg/kg), will be purchased by the World Health Organization
15948149|NCT03278431|Drug|Oxantel Pamoate|Oxantel pamoate (20mg/kg) will be produced by the University of Basel
15948150|NCT03278431|Drug|Mebendazole|Mebendazole (500 mg) from GlaxoSmithKline, donated by the World Health Organization
15948151|NCT03278418|Procedure|Tricuspid Valve Repair|It will be performed according to the surgeon preference
15948152|NCT03278418|Procedure|Left-sided valve surgery|It will be performed according to the surgeon preference
15948153|NCT03278405|Drug|Avelumab|Avelumab will be administered intravenously as an infusion, at a dose of 10 milligram per kilogram once every 2 weeks, until occurence of progressive disease, unacceptable toxicity, or any of the other criteria for withdrawal listed in the protocol .
15948154|NCT03278392|Behavioral|Trier Social Stress Test|Task instructions provided to subject (5mins), subject prepares speech on their strengths and weaknesses (5 mins), subject delivers speech before a stern evaluative committee while being video-taped (5 mins), subject completes a mental arithmetic challenge task before the evaluative committee with critiques if errors are made (5mins).
15948155|NCT03278392|Behavioral|Placebo Non-stress task|Subject engages in a friendly conversation about a neutral or happy topic (e.g. recent holiday, favorite past-times) for 15 minutes with a familiar research staff member.
15948156|NCT03278379|Drug|Avelumab|Avelumab will be administered intravenously as an infusion, at a dose of 10 milligram per kilogram once every 2 weeks, until occurence of progressive disease, unacceptable toxicity, or any of the other criteria for withdrawal listed in the protocol .
15948157|NCT03278366|Behavioral|Dancing|Participants in the intervention group will participate in daily dance activities with their teacher by following along with a video created by the dance researchers at Skidmore College. Teachers will be specifically asked to utilize the movement phrases just prior to administering any formal assessment activity within their classroom (tempo may be chosen at teacher's discretion). Furthermore, teachers may choose to utilize the dance phrases as 'brain breaks' at any point throughout their school day.
15948158|NCT03278353|Other|Exercise|"A prescription of progressive rehabilitation exercises designed to strengthen weakened muscle groups and stretch joint movements that demonstrate range of motion limitations will be provided as a home program. Treatment is based on clinical presentation and identification of impairments by the treating clinician. Participants will be seen for 3 visits over 6 weeks and a final visit 1 year post-surgery for those electing to undergo surgery.
~The interventions will consist of progressive exercise (PE) in two phases with general instruction guidelines. The assigned program will be tailored per each participant's clinical presentation and progressed based on response to exercise load. The researcher will instruct, review and supervise each program initially and, at follow-up visits; as well as monitor progress, re-enforce treatment strategies and modify the respective program accordingly. Each participant will receive a home program manual as well as a program log."
15948159|NCT03278353|Other|Manual Therapy|Hip joint and spine manual therapy techniques applied toward the impairments of the subject.
15948160|NCT03278340|Behavioral|Sun Safe Workplaces - Technology|After randomization, program staff will contact managers at the recruited employer and schedule the initial web-enabled visit in the first 6 months. Follow-up meetings will be scheduled as needed to discuss policy adoption, and managers will schedule employee education using the SSW-T online training. Staff will follow-up with managers through Month 34 (Wave 1) or Month 46 (Wave 2). Electronic materials will be published on KB's state-of-the-art web server for employers to access and use.
15948161|NCT03278340|Behavioral|Sun Safe Workplaces -In Person|After randomization, program staff will contact managers the recruited employer and schedule the initial in-person visit in the first 6 months. Follow-up meetings will be scheduled as needed to discuss policy adoption; managers will schedule employee education with SSW-IP project staff. Printed materials will be sent to SSW-IP employers 3 times during the intervention. Staff will follow-up with managers through Month 34 (Wave 1) or Month 46 (Wave 2).
15948162|NCT03278327|Procedure|Complete endoscopic resection at Day 1 and months 2, 4, 6 8 and month 10.|Endoscopic resection treatment
15948163|NCT03278327|Device|Endoscopic resection at month 2 and month 4|"System of endoscopic resection of the mucous hurts which can take several forms according to the technical necessities.
~The device the most used in this case is the system COOK Medical Duett of Laboratories.
~The duration of the treatment will be the same duration as the classic endoscopic resection, that is 30 in 60 minutes.
~The resection will be preceded by injection of physiological salt solution tinged with carmine indigo in the sub-mucous membrane."
15948164|NCT03278314|Drug|tezacaftor/ivacaftor|orally administered TEZ/IVA combination therapy
15948165|NCT03278301|Device|Robotic-assisted PCI|The CorPath GRX is intended for use in the remote delivery and manipulation of guidewires and rapid exchange balloon/stent catheters, and remote manipulation of guide catheters during percutaneous coronary intervention (PCI) procedures.
15948166|NCT03278288|Device|WellWe-Intervention group|Participants (families) allocated to the intervention group get to use WellWe-app before entering to health visit to assess the current situation of their wellbeing and utilizing these results during the health visit. The access to WellWe-app is permitted throughout the data collection period. Participants (PHNs) randomized to the intervention group get standardized two hour WellWe-training, WellWe-handbook and full access to the WellWe-app during the data collection period.
15948167|NCT03278275|Drug|One injection of 68Ga-NOTA-AE105|One injection of 68Ga-NORA-AE105
15948168|NCT03278275|Device|PET/CT|Following injection of 68Ga-NOTA-AE105 the participants will be subjected to whole body PET/CT
15948169|NCT03278262|Drug|Aflibercept (Eylea, BAY86-5321)|Treatment-naïve eyes with neovascularization AMD (Age-related Macular Degeneration), with the indication to be treated with Aflibercept. One and/or two eyes per patient.
15948170|NCT03278249|Other|Modified Atkins Ketogenic Diet|Less than 20 grams of carbohydrates per day
15948171|NCT03278236|Behavioral|TRF|Participants will be instructed to consume their habitual diet within a self-selected 10 hour period every day.
15948172|NCT03278223|Device|Test solution|A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-2.
15948173|NCT03278223|Device|Control solution|A Multi-purpose soft contact lens care solution containing polyaminopropyl biguanide, polyquaternium-1.
15948351|NCT03276871|Device|Balloon Dissection|Creation of extraperitoneal space with aid of the disposable Spacemaker balloon dissector
15948174|NCT03278197|Other|Interviews|Interviews with patients, physicians and general practitioners (GPs) to define patients' decisional needs.
15948175|NCT03278197|Other|Treatmentchoice Decisional Tool|Patients and physicians navigate through Treatmentchoice Decisional Tool and think aloud while running the tool
15948176|NCT03278197|Other|Questionnaires|Patients and physicians fill out questionnaires on the usual care, Delphi study
15948177|NCT03278197|Other|Interviews with stakeholders|Interviews with stakeholders (patients, clinicians, nurses, GP's, patient organizations, insurance companies) to determine the barriers and facilitators to the implementation of shared decision making and the decision aid.
15948178|NCT03278184|Device|tDCS sham motor cortex|the intervention 25 participants will be subjected to spine surgery then participants will be subjected to sham stimulation targeting left motor cortex area using the transcranial direct current stimulation device for 30 seconds then stop for 20 minutes.
15948179|NCT03278184|Device|active prefrontal cortex stimulation|the intervention 25 participants will be subjected to spine surgery then participants will be subjected to an active stimulation targeting left dorsolateral prefrontal cortex area using the transcranial direct current stimulation device with a current intensity of 2 mA for 20 min
15948180|NCT03278184|Device|active motor cortex stimulation|the intervention 25 participants will be subjected to spine surgery then participants will be subjected to an active stimulation targeting left motor cortex area using the transcranial direct current stimulation device with a current intensity of 2 mA for 20 min
15948181|NCT03278171|Behavioral|Impact Event Scale Revisited|Evaluating the ability of the Impact Event Scale -Revisited within 8 days following the intensive care unit exit to predict a post-traumatic stress disorder at 3 months (Impact Event Scale -Revisited score strictly greater than 34)
15948182|NCT03278158|Drug|Placebo|Subjects in the placebo arm will receive a single oral tablet containing no active drug.
15948183|NCT03278158|Drug|XEN-D0501, 1 mg/tablet|Subjects in this arm will receive a single oral tablet of XEN-D0501, 1 mg/tablet
15948184|NCT03278158|Drug|XEN-D0501, 2 mg/tablet|Subjects in this arm will receive a single oral tablet of XEN-D0501, 2 mg/tablet
15948185|NCT03278158|Drug|XEN-D0501, 4 mg/tablet|Subjects in this arm will receive a single oral tablet of XEN-D0501, 4 mg/tablet
15948186|NCT03278158|Drug|XEN-D0501, 8 mg/tablet|Subjects in this arm will receive a single oral tablet of XEN-D0501, 8 mg/tablet
15948187|NCT03278145|Genetic|Genetic analyses|Patients treated at the Institute of Hematology and Pediatric Oncology (IHOPe), a department of Prof. Y. Bertrand, for acute leukemia (LA) at the time of diagnosis initial, or relapse, after obtaining signed parental consent. The same patients will benefit from a new sample at the time of their remission balance. Analyses for this research will be made from bone marrow aspiration samples performed for diagnosis and treatment of these patients. The medical team will investigate whether RDs, in particular DCC, are expressed in acute leukemia cells at the time of diagnosis or relapse and then in these patients at the time of the remission balance. This research will be both qualitative and quantitative. Next, investigators will characterize the existence and then the level of expression of the ligand specific for DCC, Netrin-1, in these same leukemic cells, at the time of diagnosis / relapse and remission.
15948188|NCT03278132|Biological|EV71 vaccine|Two doses vaccination of EV71vaccine (Intramuscular injection, 0.5ml) with a schedule of 0, 28 days.
15948189|NCT03278119|Diagnostic Test|PET Scan and nocturnal polysomnography|Amyloid PET scans will be used to assess amyloid burden in the brain, and nocturnal polysomnography will be used to assess sleep and cardiopulmonary variables
15948192|NCT03278080|Other|Road-tracking test|Driving with simulator program for SDLP measurement
15948193|NCT03278080|Other|Car-following test|Driving with simulator program for DCV measurement
15948194|NCT03278080|Other|Harsh-braking test|Driving with simulator program for BRT measurement
15948195|NCT03278067|Other|Enhanced vaccine safety surveillance|Routinely collected primary care data from up to ten general practices to support passive surveillance. Additionally, this passive surveillance will be enhanced by the use of a customized card-based ADR reporting system.
15948196|NCT03278054|Other|Root Canal Treatment with hand instruments|Root canal treatment was performed with K files.
15948197|NCT03278054|Other|Root canal treatment with Protaper instruments|Root canals were enlarged with S1 S2 F1F2 F2 Protaper instruments
15948198|NCT03278054|Other|Root canal treatment with hybrid instrumentation|Root canal were enlarged with combination of a combination of ProTaper Universal instruments to shape the coronal and middle thirds and Hyflex CM to prepare the apical third
15948199|NCT03278041|Procedure|Submental flap for palatal reconstruction|"Under General Anesthesia the tumor in the maxilla will be resected (partial maxillectomy) with a safety margin, then the defect will be reconstructed immediately by :
~Submental artery flap : from submental area with 1 cm distance from inferior mandibular border in paddle shape.
~1st step will be identify the facial artery and vein,
~2nd step dissection and extend toward midline in subplatsmal plane. The flap contains submental artery and vein.
~3rd step creating submucous tunnel between vestibular border of post maxillectomy defect and to extraoral incision .
~The flap will be through the oral cavity and will be anchored to the intact remaining hard plate with bone sutures by 2-0 vicryl® suture."
15948200|NCT03278041|Device|maxillary obturator|immediate surgical obturator
15948201|NCT03278028|Drug|A-101 Topical Solution|A-101 Topical Solution
15948202|NCT03278028|Drug|A-101 Vehicle Solution|A-101 Vehicle Solution
15948203|NCT03278015|Drug|Nab-paclitaxel plus Gemcitabine|Nanoparticle albumin-bound paclitaxel is given at 100mg/m2 intravenously over 30 minutes in combination with Gemcitabine 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.
15948204|NCT03278015|Drug|Gemcitabine monotherapy|Gemcitabine is given at 1000mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.
15948205|NCT03278015|Drug|S-1 monotherapy|S-1 is orally administered (40-60 mg according to the body surface, Bid) on day 1-14 of each 21-days cycle. Number of cycle: 6 cycles.
15948206|NCT03277976|Device|PVI using ThermoCool® SmartTouch® Catheter|PVI using RFA, using ThermoCool® SmartTouch® Catheter (Biosense Webster Inc., CA, US), guided by Ablation Index
15948302|NCT03277287|Radiation|Fractional CO2 laser|Fractional CO2 laser will be applied in cleft lip scar to assess and evaluate the later appearance of the scar
15948207|NCT03277976|Device|PVI using ThermoCool® SmartTouch SF® Catheter|PVI using RFA, using ThermoCool® SmartTouch SF® Catheter (Biosense Webster Inc., CA, US), guided by Ablation Index
15948208|NCT03277963|Device|Pain perception tests (mechanical : VON FREY ELECTRONIQUE or electrical stimulus : PAIN MATCHER®)|From a basal level causing no particular sensation, the mechanical or electrical stimulus is applied with a constant increasing rate of progression.
15948209|NCT03277950|Other|Virtual reality with feedback|Individuals with stroke play game with correction of movement.
15948210|NCT03277950|Other|Virtual reality without feedback|Individuals with stroke play game without correction of movement.
15948211|NCT03277950|Other|Healthy|Healthy do not play game
15948212|NCT03277937|Procedure|angiography in EUS-injection of coils + CYA|Doppler imaging will be used to allow direct visualization of the varices flow. The gastric vessels will be followed from the cardia to the proximal part of the esophagus, to detect the feeding vessel (FV). Once the FV has been found, a 19-gauge EUS-FNA will be used to access the vessel. An angiography will be performed using 5-10 ml of water-soluble contrast under fluoroscopy, to ensure intravascular location and study varix flow direction. Finally, patients will be treated by EUS-deployment of coils followed by CYA injection. The coils will be delivered into the vessel through the FNA needle, using the stylet as a pusher. The 2-Octyl-CYA will be used. It will be injected always after the coils deployment and then 1 mL of saline solution will be used to flush the glue completely.
15948213|NCT03277924|Drug|Sunitinib 37.5 MG, Sunitinib 25 MG [Sutent]|Treatment will continue until disease progression, development of unacceptable toxicity, non-compliance, withdrawal of consent by the patient or investigator decision.
15948214|NCT03277924|Drug|Nivolumab 100 MG/10 ML [Opdivo]|Treatment will continue until disease progression, development of unacceptable toxicity, non-compliance, withdrawal of consent by the patient or investigator decision.
15948215|NCT03277898|Behavioral|Aerobic Exercise|Three weekly moderate-vigorous intensity supervised aerobic exercise training for the duration of adjuvant chemotherapy. Home-based exercise will also be introduced in week 3 of the intervention.
15948216|NCT03277898|Behavioral|Usual Care (Wait-list Control)|Three weekly moderate-vigorous intensity supervised aerobic exercise training starting upon adjuvant chemotherapy completion. Home-based exercise will also be introduced in week 3 of the intervention.
15948217|NCT03277885|Other|chronic pain|work related chronic pain
15948218|NCT03277872|Device|Laryngoscopy with GlideScope (GVL) Blade|"st Laryngoscopy with GVL Blade
~nd Laryngoscopy with MAC Blade
~rd Laryngoscopy and ETT insertion with either GVL or MAC Blade according to 2nd randomization"
15948219|NCT03277872|Device|Laryngoscopy with MacIntosh (MAC) Blade|"st Laryngoscopy with MAC Blade
~nd Laryngoscopy with GVL Blade
~rd Laryngoscopy and ETT insertion with either GVL or MAC Blade according to 2nd randomization"
15948220|NCT03277859|Behavioral|SAA-TBI|Yoga twice a week for 75 minutes for 8 weeks
15948221|NCT03277846|Device|Nexalin Based Trans-Cranial Electrical Stimulation|The Nexalin device, FDA clearance (501K=K024377, Classification: Stimulator, Cranial Electrotherapy: CFR 882. 5800: U.S. Patent #6904322B2), produces a square waveform that provides trans-cranial electrical stimulation to the brain delivered at a frequency of 77.5 Hz at 0 to 4 mA peak current.
15948222|NCT03277833|Dietary Supplement|Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day)|Gynostemma Pentaphyllum(Dungkulcha) Extract(400mg/day), parallel design
15948223|NCT03277833|Dietary Supplement|Placebo|Placebo, parallel design
15948224|NCT03277820|Dietary Supplement|Probactiol Mini|6 droplets of Probactiol Mini contain 1 billion bacteria (Lactobacillus rhamnosus GG and Bifidobacterium lactis BB-12)
15948225|NCT03277794|Behavioral|HOP-C|Service provision will be provided by Loft and Covenant House for the transitional case management component, the peer component will be supported through Sketch Arts, and the mental health component will be provided by a post-doctoral fellow clinical psychologist and a mindfulness therapist from the Centre for Mindfulness Studies, supervised by Dr. Sean Kidd.
15948226|NCT03277794|Behavioral|Transitional Case Management Only|Participants in this arm will be provided with a transition-focused community support worker who will assist in areas ranging from general support and encouragement to assistance in navigating relevant systems. They will have weekly contacts with participants by phone, informal contact via text and email, and at least twice per month will visit the participant where they are residing. It is expected that all participants will engage a community support worker. The transitional case manager hired into this role will be highly experienced in case management for youth.
15948227|NCT03277781|Other|Screening|Screening for AAA
15948228|NCT03277768|Device|Resonance Raman Spectroscopy (RRS)|Pre and post-ductal RRS measurements will be obtained daily for a maximum of 14 data collection times in infants with and without PDAs.
15948229|NCT03277755|Drug|AL-335 800 mg|Participants will receive AL-335 800 mg (2 tablets of 400 mg AL-335) single oral dose on Day 1 of part 1 and in combination as AL-335 + ODV + SMV once daily orally from Day 1 to 14 of part 2.
15948230|NCT03277755|Drug|ODV 25 mg|Participants will receive ODV 25 mg (1 tablet of 25 mg ODV) single oral dose on Day 8 of part 1 and in combination as AL-335 + ODV + SMV once daily orally from Day 1 to 14 of part 2.
15948231|NCT03277755|Drug|SMV 75 mg|Participants will receive SMV 75 mg in combination as AL-335 + ODV + SMV once daily orally from Day 1 to 14 of part 2.
15948232|NCT03277742|Behavioral|Community intervention|Training of patients, health personnel and community health workers. Bidirectional screening. Monitoring blood glucose levels. Home visits. Medical referral. DOTS.
15948233|NCT03277742|Drug|Standard of care|DOTS plus standard DM2 care
15948234|NCT03277729|Biological|Chimeric Antigen Receptor T-Cell Therapy|Given CD20 CAR T cell IV
15948235|NCT03277729|Drug|Cyclophosphamide|Given IV
15948236|NCT03277729|Other|Laboratory Biomarker Analysis|Correlative studies
15948237|NCT03277729|Procedure|Leukapheresis|Undergo leukapheresis
15948238|NCT03277729|Drug|Fludarabine Phosphate|Given IV
15948303|NCT03277274|Drug|TAK-954|TAK-954 intravenous infusion.
15948304|NCT03277261|Biological|Ublituximab|Subjects will be randomized in a [1:1] ratio to receive either ublituximab/oral placebo on specified days or teriflunomide/IV placebo (14 mg, OD starting on Week 1 Day 1)
15948305|NCT03277261|Drug|Teriflunomide|Subjects will be randomized in a [1:1] ratio to receive either ublituximab/oral placebo on specified days or teriflunomide/IV placebo (14 mg, OD starting on Week 1 Day 1)
15948352|NCT03276858|Drug|CRN00808|Investigational drug
15948239|NCT03277716|Procedure|TACE|TACE: With the patient under local anesthesia, a 5F French catheter was introduced into the abdominal aorta via the femoral artery using the Seldinger technique. Hepatic arterial angiography was performed using fluoroscopy to guide the catheter into the celiac and superior mesenteric arteries. Then, the feeding arteries, tumor, and vascular anatomy surrounding the tumor were identified. Subsequently, a microcatheter was super-selectively inserted into the feeding arteries. Then, a mixture solution containing chemotherapeutic agents and embolic agents were infused into the artery according to the size and blood supply of the tumors.
15948240|NCT03277716|Procedure|MWA|MWA: All patients were instructed to fast from all foods for 12 hours preoperatively. During the procedure, a CT scan was used to locate the liver tumors, and to design the optimal puncture needle route. Routine disinfection and local anesthesia was applied around the puncture point, and a 16-gauge microwave antenna was gradually inserted into the tumor along the pre-determined angle. Settings of the MWA parameters depended on the manufacturer's recommendation and our experience.
15948241|NCT03277716|Device|MWA system|MWA system is a kind of medical treatment instrument to restrain and kill tumor based on microwave heating technique and biology heating effect theory.
15948242|NCT03277716|Drug|Chemoembolization|Chemotherapeutic drugs: adriamycin，epirubicin and pirarubicin. Embolic agent: lipiodol and embolic microspherea The mixture solution containing chemotherapeutic drugs and embolic agent were infused into the artery according to by the number and size of the lesions, liver and kidney function of the patient, and blood supply of the tumors.
15948243|NCT03277703|Biological|Influenza vaccine|"The primary aim of this study is to assess the immunogenicity of booster dose influenza vaccine strategy in patients with rheumatologic diseases and IBD who are receiving immunosuppressive therapies.
~Secondary aims of this study include assessment of the safety and clinical efficacy, of booster dose influenza vaccine in the prevention of influenza-like illnesses (ILI) in this patient population"
15948244|NCT03277690|Drug|Levoketoconazole|"During the double-blind Withdrawal Phase, patients will receive up to 1200 mg levoketoconazole daily.
~During the double-blind Restoration Phase, patients will receive levoketoconazole plus placebo."
15948245|NCT03277690|Drug|Placebo|"During the double-blind Withdrawal Phase, patients will receive placebo tablets.
~During the double-blind Restoration Phase, patients will receive placebo plus levoketoconazole."
15948246|NCT03277677|Drug|Normal saline|for resuscitation in sepsis patients
15948247|NCT03277677|Drug|Ringer's Acetate|for resuscitation in sepsis patients
15948248|NCT03277664|Behavioral|intervention group|"All the device-monitored adherence data from the previous week were downloaded from the background database and calculated by a qualified asthma nurse. Through free IMS (WeChat; Tencent, Shenzhen, CHN) available on mobile, the nurse offered feedback to the caregivers weekly according to the adherence rate and reminded them to keep taking the ICS. Caregivers were asked monthly Has our child inhaled the medicine according to the doctor's instructions? and How about the frequency? by telephone."
15948249|NCT03277651|Diagnostic Test|hemodynamics tests|Hemodynamics tests for intrahepatic blood flow by colour doppler ultrasound
15948250|NCT03277638|Drug|Pembrolizumab at 7 days prior|Pembrolizumab injections 7 days before surgery
15948251|NCT03277638|Drug|Pembrolizumab at 14 days post|Pembrolizumab injections 14 days after surgery
15948252|NCT03277638|Drug|Pembrolizumab at 35 days post|Pembrolizumab injections 35 days after surgery
15948253|NCT03277638|Procedure|Laser Interstitial Thermotherapy|surgical procedure to heat hard to reach tumors with a laser beam
15948254|NCT03277625|Procedure|modified omega-shaped single-loop|A double-layer, end-to-side, duct-to-mucosa PJ using interrupted polydioxanone 5-0 suture (PDS II, Ethicon, Somerville, USA) for the outer layer and interrupted polypropylene 5-0 suture (Prolene, Ethicon, USA) for the inner layer is the standard technique during PD at our Institution. For the modified omega-shaped single-Loop reconstruction the loop between PJ and HJ is left intentionally longer at about 25-30 cm and an additional side-to-side jejunojejunal anastomosis is performed at the lowest point between the afferent and efferent loops of the HJ This intestinal anastomosis is done in a double-layer continuous PDS 5-0 suture technique. Neither sealants, nor stents are being applied at the PJ. In cases of thin walled and tiny hepatic ducts, the HJ is splinted using an externally diverted T-tube.
15948255|NCT03277599|Drug|IV patient-controlled analgesia (PCA) tramadol|Tramadol infusion (PCA): 400 mg tramadol, IV 4 mg/mL tramadol solution into 100 mL normal saline; PCA settings: 0.3 mg/kg bolus, 10 mg Demand dose and 20 min lock out interval, six-hour limit infusion to attain 100 mg. Maximum daily dose was set at 400 mg.
15948256|NCT03277599|Drug|ultrasound guided superficial cervical plexus block|ultrasound guided superficial cervical plexus blockage with 10 ml % 0.25 bupivacaine
15948257|NCT03277599|Drug|ultrasound guided Great Auricular nerve block|ultrasound guided Great Auricular nerve blockage with 5 ml % 0.25 bupivacaine +IV patient-controlled analgesia (PCA) tramadol
15948258|NCT03277586|Drug|Probio'Stick|Probiotic supplement containing Lactobacillus helveticus and Bifidobacterium longum
15948259|NCT03277586|Drug|Placebo|Identically formulated and packaged inactive substance
15948260|NCT03277573|Drug|Salsalate|Salsalate is a non-acetylated dimer of salicylic acid, and is classified as a non-steroidal anti-inflammatory drug (NSAID). Salsalate has been commercially available in the US as a prescription drug for the relief of the signs and symptoms of rheumatoid arthritis, osteoarthritis, and related rheumatic disorder for decades.
15948261|NCT03277573|Drug|Placebo|Inactive ingredient
15948262|NCT03277560|Other|No Intervention as it is an observational study|No Intervention as it is an observational study
15948263|NCT03277534|Other|Electrical stimulation|sensory electrical stimulation was applied prior to upper limb functional training
15948264|NCT03277534|Other|Sham electrical stimulation|electrodes were placed on the same location as the Electrical stimulation condition, but no electric current was applied
15948265|NCT03277521|Other|Intermittent theta burst stimulation|Intermittent theta burst stimulation (iTBS) is a non-invasive brain stimulation technique that can increase corticomotor excitability.
15948306|NCT03277248|Biological|Ublituximab|Subjects will be randomized in a [1:1] ratio to receive either ublituximab/ oral placebo on specfied days or teriflunomide/ IV placebo (14mg, once daily starting on Week1 Day1)
15948307|NCT03277248|Drug|Teriflunomide|Subjects will be randomized in a [1:1] ratio to receive either ublituximab/ oral placebo on specfied days or teriflunomide/ IV placebo (14mg, once daily starting on Week1 Day1)
15948353|NCT03276858|Drug|Placebo Oral Solution|Placebo
15948266|NCT03277508|Device|BCI Robot Assisted Hand Therapy|"18 sessions (3 times per week for a total of 6 weeks) of 1.5 hours each training (60 minutes of BCI Robot and 30 minutes of the standard hand therapy).
~Session 1-3. Peg game: Lateral movement of gears/cups Session 4-6. Moving cups onto a shelf: Elevation process for the arm, small cups to be used.
~Session 7-9. Carrying of basket: Heavier load to be used, patient to hold the basket by the handles at the side, not by its base.
~Session 10-12. Opening bottle + pouring into a cup: Training of ADL Session 13-15. Eating: Use of a modified spoon to train ADL Session 16-18. Box and blocks: Precise index finger and thumb control"
15948267|NCT03277508|Device|CPM Robot Assisted Hand Therapy|18 sessions (3 times per week for a total of 6 weeks) of 1.5 hours each training (60 minutes of Passive Robot and 30 minutes of the standard hand therapy).The procedure will include the following: Session 1-18: Continuous passive motion
15948268|NCT03277495|Behavioral|Brief behavioral counseling|Staff will engage in behavioral counseling to identify strategies for reducing combustible cigarette use. All participants in the trial receive this intervention
15948269|NCT03277495|Other|Nicotine present in the SREC device and refills|Nicotine is present in the liquid in the SREC device and all refills. Two-thirds of the sample will receive nicotine in their SREC; one-third will not (placebo)
15948270|NCT03277482|Drug|Durvalumab|Durvalumab is given by intravenous infusion every 4 weeks for a maximum of 13 doses over 52 weeks. One cycle is defined as every 4 weeks. Each infusion will take approximately 1 hour.
15948271|NCT03277482|Drug|Tremelimumab|Tremelimumab is given by intravenous infusion every 4 weeks for a maximum of 4 doses over 16 weeks. One cycle is defined as every 4 weeks. If receiving both durvalumab and tremelimumab for the first 4 cycles, they will be given on the same day. Each infusion will take approximately 1 hour
15948272|NCT03277482|Radiation|Radiation Therapy|Radiation treatment will begin on the same day as the first immunotherapy infusion or on the following day. The radiation treatment course is either 1 day or 5 days.
15948273|NCT03277469|Device|MRI|Medical imaging technique used in radiology to form pictures of the anatomy and the physiological processes of the body
15948274|NCT03277469|Radiation|Brachytherapy|Radiation therapy that is delivered by inserting radioactive sources directly into a tumor
15948275|NCT03277469|Device|MRI Tracker|The MR tracking device consists of a series of radiofrequency (RF) microcoils that are embedded into brachytherapy catheter stylet. The RF microcoils allows for accurate spatial localization of an individual brachytherapy catheter.
15948276|NCT03277456|Biological|MVA-NP+M1|Intramuscular injection of novel vaccine
15948277|NCT03277443|Procedure|Computer guided surgery|Preoperative surgical simulation and immediate postoperative evaluation will be carried out using Multi Slice CT scan.Craniofacial images from 3D computerized tomography (3D-CT scan) can be used to create a 3D model, which can in turn be used for 3D Cephalometry measurements and surgical simulation.The process of 3D-model contains mounting of 3D virtual models in a 3D virtual articulator; and repositioning of 3D virtual models according to the STO then Fabrication of a 3D virtual intermediate surgical wafer; and materialization of the surgical wafer using a stereolithographic technique. The 3D model can produce actual movement of surgical cuts and movement of segments accordingly
15948278|NCT03277443|Procedure|Conventional model surgery|preparation for orthognathic surgery which involves diagnosis with 2D cephalometric radiograph, face-bow transfer and model surgery on plaster dental cast, and fabrication of intermediate and final occlusal splint.
15948279|NCT03277443|Device|2D cephalometric radiograph|2D cephalometric radiograph
15948280|NCT03277443|Device|3D computerized tomography|3D computerized tomography
15948281|NCT03277430|Procedure|Live donor uterus transplantation|Transplantation of uterus from a living donor.
15948282|NCT03277430|Procedure|Deceased donor uterus transplantation|Transplantation of uterus from a deceased brain-dead donor.
15948283|NCT03277430|Drug|Tacrolimus|Maintenance immunosuppression in UTx recipient will be reduced to tacrolimus monotherapy to minimalize fetal compromise.
15948284|NCT03277417|Other|Echocardiography|Imaging of fetal heart and amniotic fluid
15948285|NCT03277404|Procedure|Root canal treatment with smear layer removal|Canal were irrigated with Naocl and EDTA to remove smear layer
15948286|NCT03277404|Procedure|Root canal treatment without smear layer removal|only sodium hypochlorite was used for irrigation
15948287|NCT03277391|Procedure|Serratus anterior plane block|SPB realized under ultrasound guidance. Infiltration of local anesthetic (bolus then infusion through a multi-holed catheter) is realized under the serratus anterior muscle at a level situated around the 5th to 6th intercostal space on the anterior axillary lign, in order to anesthetize the cutaneous lateral branches of the intercostal nerves, with a first ropivacaine 0,375% bolus (0,4ml/kg), followed by an infusion of ropivacaine 0,2% at a 10ml/hr rate, through a multi-holed catheter, for a duration of 24 hours.
15948288|NCT03277391|Device|patient-controlled analgesia|Each patient controls his analgesia with an IV bolus of 2mg of morphine every 10 minutes if needed, with a maximum of 20mg every 4 hours.
15948289|NCT03277378|Device|lead placement followed by BurstDR stimulation|lead placement followed by BurstDR stimulation
15948290|NCT03277365|Other|Receive genetic risk information|Risk scores are provided by ResearchKit app.
15948291|NCT03277352|Drug|INCAGN01876|In Phase 1 subjects will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose and schedule according to cohort and treatment group enrollment. In Phase 2, subjects will be administered IV study drug at the recommended dose from Phase 1.
15948292|NCT03277352|Drug|Epacadostat|Epacadostat will be self-administered orally at the protocol-defined dose.
15948293|NCT03277352|Drug|Pembrolizumab|Pembrolizumab will be administered IV at the protocol-defined dose.
15948294|NCT03277339|Drug|Paroxetine|Deroxat® (20 mg/day) 3 week; can be increase on week 2 until 50 mg.
15948295|NCT03277339|Other|Thermal cure|Thermal cure is realized for 3 weeks
15948296|NCT03277326|Procedure|ISB|ISB block with 0.5% ropivicaine 15mls ( 45mg )
15948297|NCT03277326|Procedure|aSSB|aSSB block with 0.5% ropivicaine 15mls ( 45mg )
15948298|NCT03277326|Procedure|pSSB|pSSB block with 0.5% ropivicaine 15mls ( 45mg )
15948299|NCT03277313|Biological|HYQVIA|Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (IGI, 10% with rHuPH20)
15948300|NCT03277313|Biological|GAMMAGARD LIQUID|GAMMAGARD LIQUID IGI (Human), 10% Solution
15948301|NCT03277300|Dietary Supplement|dietary supplement|good dietary supplement for critically ill patients
15983808|NCT03009019|Other|DFN-15 Placebo|
15948308|NCT03277235|Behavioral|Resilience model-based total care plan|12-week care plan with 5 times face-to-face intervention and weekly phone call follow-up to increase the protective factors (positive thinking. problem-solving, finding meaning, and social connection) and decrease the risk factors (disease-related distress and defense coping) of resilience
15948309|NCT03277222|Biological|IN insulin|IN insulin twice daily taken after breakfast and again after dinner using the nasal delivery device.
15948310|NCT03277222|Biological|Sterile Saline placebo|Sterile Saline placebo twice daily taken after breakfast and again after dinner using the nasal delivery device.
15948311|NCT03277209|Drug|Plerixafor|Plerixafor will be administered via IV as a continuous 7 day intravenous infusion starting at a dose of 20 ug/kg/hr and subsequent dose levels of 40, 80 and 120 ug/kg/hr
15948312|NCT03277196|Drug|Ivacaftor|Ivacaftor will be administered every 12 hours (q12h) from Day 1 through the morning dose of the Week 96 Visit.
15948313|NCT03277183|Drug|Low dose erythropoietin|Subjects randomized to this arm will receive low-dose of EPO administered thrice weekly
15948314|NCT03277183|Drug|High dose erythropoietin|Subjects randomized to this arm will receive the same cumulative dose of EPO administered as a high-dose of EPO every 2 weeks
15948315|NCT03277170|Drug|Montelukast Oral Granules|Montelukast granules, 30 mg, mixed with applesauce
15948316|NCT03277157|Dietary Supplement|B. lactis B94|A probiotic dose of 15 billion per capsule.
15948317|NCT03277157|Dietary Supplement|Placebo|Placebo capsule
15948318|NCT03277144|Device|TST-TriStaple(3lines stapler)Technology|Duodenal stump closed using a Tristaple ( three-lines linear stapler) device
15948319|NCT03277144|Other|other conventional techniques|Duodenal stump closed using other conventional techniques entailing manual suture or mechanical devices with only two lines of sutures.
15948320|NCT03277131|Device|DURAFIBER Ag|DURAFIBER Ag is a commercially available absorbent, non-woven, silver-containing antimicrobial dressing
15948321|NCT03277118|Device|Wireless Wearable Device|Wireless Wearable Device will be placed on the wrist of the patient prior to extubation in the ICU to record patient activity in terms of steps and sleep quality.
15948322|NCT03277105|Drug|Dara SC|Participants will receive a fixed dose of Dara SC as 1800 mg daratumumab with rHuPH20 2000 U/mL, once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study.
15948323|NCT03277105|Drug|Dara IV|Participants will receive Dara IV 16 mg/kg once weekly in Cycle 1 and 2, every 2 weeks in Cycle 3 to 6, every 4 weeks in Cycle 7 and thereafter until disease progression, unacceptable toxicity or the end of study.
15948324|NCT03277092|Device|VeinViewer®|Near-infrared (NIR) technology consists on light-emitting diodes placed underneath the hand, that makes vessels visible by projecting the processed image in a green light directly on to the puncture site
15948325|NCT03277092|Procedure|Usual care|The blood drawing is performed traditionally
15948326|NCT03277079|Drug|statin + ezetimibe|Combination of two drugs
15948327|NCT03277079|Drug|statin + ezetimibe + Nutraceuticals|Combination of two grus plus nutraceuticals
15948328|NCT03277066|Drug|Diclofenac Sodium Active Topical Patch 1|HP-5000 Active Topical Patch 1 were applied on subjects with Osteoarthritis of the knee(s)
15948329|NCT03277066|Drug|Diclofenac Sodium Active Topical Patch 2|HP-5000 Active Topical Patch 2 were applied on subjects with Osteoarthritis of the knee(s)
15948330|NCT03277066|Drug|Placebo patch|Topical placebo patches were applied on subjects with Osteoarthritis of the knee(s)
15948331|NCT03277053|Device|Mobile application|A mobile application designed specifically for colorectal patients treated within an enhanced recovery pathway. Contains information, guidelines, questionnaires and feedback
15948332|NCT03277053|Other|Control.|Patient receive an ipad with no application.
15948333|NCT03277040|Other|CSA membership|Bi-weekly fresh food delivery
15948334|NCT03277027|Other|interventional study|The participants wear a monitoring equipment (Actigraph) for a week. And parents do Child Health Questionnaire Parent Form 50 (CHQ-PF50), and Korean Parenting Stress Index-Short Form (K-PSI-SF)
15948335|NCT03277001|Drug|Rivaroxaban|Rivaroxaban, po. 10mg/day（CrCl≥ 50 ml/min）or 5 mg /day (CrCl ≥ 30 and < 50 ml/min) po.
15948336|NCT03277001|Drug|Enoxaparin|Enoxaparin 40mg IH
15948337|NCT03276988|Drug|Period 1 GX-30, Period 2 THYROGEN®|Part B - Sequence A. GX-30 0.9mg will be administered at Day 1 and Day 2 in Period 1. After wash-out period of 2 to 3 weeks, THYROGEN® 0.9mg will be administered in Period 2.
15948338|NCT03276988|Drug|Period 1 THYROGEN®, Period 2 GX-30|Part B - Sequence B. THYROGEN® 0.9mg will be administered at Day 1 and Day 2 in Period 1. After wash-out period of 2 to 3 weeks, GX-30 0.9mg will be administered in Period 2.
15948339|NCT03276975|Drug|TISSEEL|TISSEEL is a fibrin sealant indicated for use as an adjunct to hemostasis in adult and pediatric patients (>1 month of age) undergoing surgery when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. TISSEEL is effective in heparinized patients
15948340|NCT03276962|Biological|RTS,S/AS01E (Full dose)|Subjects will receive intramuscular injection of RTS,S/AS01E (full dose: 0.5 ml).
15948341|NCT03276962|Biological|RTS,S/AS01E (1/5th dose)|Subjects will receive intramuscular injection of RTS,S/AS01E (1/5th dose: 0.1 ml).
15948342|NCT03276962|Biological|Rabies vaccine|Subjects will receive intramuscular injection of rabies vaccine (0.1 ml).
15948343|NCT03276949|Device|Blood glucose measurement|Device used to measure blood glucose levels
15948344|NCT03276936|Drug|FMX103 1.5%|FMX103 1.5% minocycline foam
15948345|NCT03276910|Drug|EPREX|6 doses at 50 IU/kg or 20 IU/kg in subcutaneous use
15948346|NCT03276910|Drug|sodium chloride AGUETTANT 0.9%|6 injections at 1ml in subcutaneous use
15948347|NCT03276897|Other|Nutriage SPF 30 day cream and Nutriage night cream (Difa Cooper S.p.a, Italy)|A fixed quantity of both cosmetic products was applied for an uninterrupted period of 3 months, on the face included the submental area (day cream at the morning and the night cream at the evening), preferentially always at the same hour, with a mild massage
15948348|NCT03276884|Other|Experimental Infant Formula|amino acid-based infant formula powder
15948349|NCT03276884|Other|Control Infant Formula|amino acid-based infant formula powder
15948350|NCT03276871|Procedure|Telescopic Dissection|Creation of extraperitoneal space with blunt dissection using the laparoscopic probe
15948354|NCT03276858|Drug|Midazolam oral solution|Midazolam as part of the drug-drug interaction arm of the study
15948355|NCT03276858|Drug|Placebo oral capsule|Placebo
15948356|NCT03276845|Diagnostic Test|Ultrasound of the breast|Multiparametric ultrasound of the breast including elastography, color/power Doppler, contrast agent application and 3D sonography.
15948357|NCT03276832|Drug|Imiquimod|Applied cutaneously
15948358|NCT03276832|Other|Laboratory Biomarker Analysis|Correlative studies
15948359|NCT03276832|Biological|Pembrolizumab|Given IV
15948360|NCT03276819|Procedure|Samples collection|OPML biopsy or resection, biopsy of normal oral mucosa, surgical specimen of HNSCC, saliva samples, buccal brushes, blood samples
15948361|NCT03276819|Behavioral|Psychological and Sociological evaluation|Cohort B ....
15948362|NCT03276819|Behavioral|Intensive and sustained smoking cessation program|Evaluation of efficacy of the smoking cessation program (intensive and sustained versus minimal)
15948363|NCT03276819|Behavioral|Tobacco and alcohol status follow-up|Evaluation of the tobacco and alcohol status all along the study (questionnaires)
15948364|NCT03276806|Behavioral|tobacco dependence/smoking cessation counseling|Standard of care tobacco dependence/smoking cessation counseling offered to all smokers at Boston Medical Center.
15948365|NCT03276806|Behavioral|SDM|SDM is three-fold to: 1) conduct a tailored discussion on tradeoffs of LDCT screening, consistent with CMS requirements for SDM using a decision aid; 2) directly connect interested patients to LDCT screening; 3) to empower and motivate patients to quit smoking within the LDCT screening context.
15948366|NCT03276806|Other|Decision Aid|The decision aid is a 4-page paper format with the following features: 1) LDCT screening harms and benefits information, written in plain language and using pictographs, easily understood by those with low health literacy; 2) prompts to clarify patient values and preferences and to stimulate discussion about trade-offs; 3) clear quit smoking messaging and resources (1-800-QUIT-NOW).
15948367|NCT03276806|Other|LDCT brochure|A informational brochure developed by the BMC screening program about low dose CT screening for lung cancer.
15948368|NCT03276793|Other|MRI scan|Patients will undergo an MRI scan
15948369|NCT03276793|Behavioral|Behavioral testing|Patients will complete a series of cognitive tasks
15948370|NCT03276780|Behavioral|Counseling|Both groups receive smoking cessation counseling although one is focused on medication adherence and addressing barriers to adherence while the other is focused on standard behavioral strategies to quit smoking
15948371|NCT03276780|Drug|combination NRT|Both groups will receive combination NRT to help with smoking cessation
15948372|NCT03276767|Other|Endre|"The online intervention, Endre, a digital smoking cessation counsellor that communicates with the user primarily through interactive web-sessions. Intervention content is tailored based on user input and individual usage pattern. Up to 14 unique sessions is assigned to the users during the study period, one each day. If a user does not start a session by noon on the second day a reminder will be sendt."
15948373|NCT03276741|Dietary Supplement|gastric soft/bland diet|Patients in the experimental group will have a gastric soft/bland diet available.
15948374|NCT03276728|Drug|AMG 986 IV Dose Level A or matching Placebo|Single dose Healthy Volunteers
15948375|NCT03276728|Drug|AMG 986 IV Dose Level B or matching Placebo|Single dose Healthy Volunteers
15948376|NCT03276728|Drug|AMG 986 IV Dose Level C or matching placebo|Single dose Healthy Volunteers
15948377|NCT03276728|Drug|AMG 986 IV Dose Level D or matching placebo|Single dose Healthy Volunteers
15948378|NCT03276728|Drug|AMG 986 IV Dose Level E or matching Placebo|Single dose Healthy Volunteers
15948379|NCT03276728|Drug|AMG 986 IV Dose Level F or matching Placebo|Multiple daily dose Healthy Volunteers
15948380|NCT03276728|Drug|AMG 986 IV Dose Level G or matching Placebo|Multiple daily dose Healthy Volunteers
15948381|NCT03276728|Drug|AMG 986 Oral Dose Level A or matching Placebo|Single dose Healthy Volunteer
15948382|NCT03276728|Drug|AMG 986 Oral Dose Level B or matching Placebo|Single dose Healthy Volunteer
15948383|NCT03276728|Drug|AMG 986 Oral Dose Level C or matching Placebo|Single dose Healthy Volunteer
15948384|NCT03276728|Drug|AMG 986 Oral Dose Level D or matching Placebo|Single dose Healthy Volunteers
15948385|NCT03276728|Drug|AMG 986 Oral Dose Level E or matching Placebo|Single dose Healthy Volunteers
15948386|NCT03276728|Drug|AMG 986 Oral Dose Level F or matching Placebo|Single dose Healthy Volunteers
15948387|NCT03276728|Drug|AMG 986 Oral Dose Level A or matching Placebo|Multiple daily dose Healthy Volunteers
15948388|NCT03276728|Drug|AMG 986 Oral Dose Level B or matching Placebo|Multiple daily dose Healthy Volunteers
15948389|NCT03276728|Drug|AMG 986 Oral Dose Level C or matching Placebo|Multiple daily dose Healthy Volunteers
15948390|NCT03276728|Drug|AMG 986 Oral Dose Level D or matching Placebo|Multiple daily dose Healthy Volunteers
15948391|NCT03276728|Drug|AMG 986 Oral Dose Level E or matching Placebo|Multiple daily dose Healthy Volunteers
15948392|NCT03276728|Drug|AMG 986 Oral Dose Level F or matching Placebo|Multiple daily dose Healthy Volunteers
15948393|NCT03276728|Drug|AMG 986 Oral Dose Regimen or matching placebo - R|Multiple daily dose - Patients with heart failure and reduced ejection fraction
15948394|NCT03276728|Drug|AMG 986 Oral Dose Regimen or matching placebo - P|Multiple daily dose - Patients with heart failure and preserved ejection fraction
15948395|NCT03276702|Procedure|Re-biopsy|For those participants who agree, a biopsy of their tumor to obtain tissue for genetic analysis will be done at the time of relapse or disease progression.
15948396|NCT03276702|Other|Questionnaire|Parents or patients will be asked to complete a questionnaire to assess the impact and perception of an optional/research only biopsy. A second questionnaire will be administered approximately 4-8 weeks after biopsy to assess decisional regret.
15948397|NCT03276689|Drug|Duloxetine|The patients will take duloxetine for 8 weeks.
15948398|NCT03276689|Drug|Pregabaline|The patients will take pregabaline for 8 weeks.
15948399|NCT03276689|Other|Placebo|The patients will take placebo for 8 weeks.
15948466|NCT03276104|Procedure|IOL exchange|Intraocular lens exchange with retropupillary iris-claw lens
15948507|NCT03275766|Other|SMA inhibitory|1 Hz stimulation of preSMA/SMA (15 sessions/3weeks, 1500 stimuli per session, stimulation intensity 100% of the individual active motor threshold; in total 22500 stimuli
15948400|NCT03276676|Drug|Multi-tracer PET exams of [18F]FLT and [18F]Fluciclovine|Multi-tracer PET exams of [18F]FLT and [18F]Fluciclovine will be acquired in each patient at up to three time points: (1) prior to any tumor-directed therapy, either prior to surgery or immediately after surgery providing a complete surgical resection was not performed and confirmed by a post-operative contrast MRI scan where residual tumor > 1.0 cm in diameter was present and prior to any tumor-directed therapy; (2) at the conclusions of the initial (~6-8 weeks) chemoradiotherapy; and (3) patients with MRI-documented possible recurrence/progression versus treatment effect (pseudoprogression) within 6 months from the time of completion of chemoradiation.
15948401|NCT03276663|Other|Formula feeding regimen|The feeding regimen consists of an existing commercial starter formula followed by a new follow-up formula
15948402|NCT03276650|Other|data collection|biological, administrative, clinical, outcome date
15948403|NCT03276637|Genetic|Whole exome sequencing|Whole exome sequencing at 125x coverage (i.e., at least 125 sequencing reads covering each position within the exome region of interest) performed at the Laboratory of Molecular Medicine's Clinical Laboratory Improvement Amendments (CLIA) certified laboratory on 75 enrolled individuals
15948404|NCT03276624|Procedure|CABG|surgical revascularization of stenosed coranary arteries using arterial and venous grafts.
15948405|NCT03276611|Other|echocardiograghy|transthoracic echocardiograghy
15948406|NCT03276598|Drug|Amlodipine|Treatment for four weeks. Dose: 5 mg o.d.
15948407|NCT03276598|Drug|Bisoprolol|Treatment for four weeks. Dose: 5 mg o.d.
15948408|NCT03276598|Drug|Hydrochlorothiazide|Treatment for four weeks. Dose: 25 mg o.d.
15948409|NCT03276598|Drug|Losartan|Treatment for four weeks. Dose: 50 mg o.d.
15948410|NCT03276598|Drug|Placebo|Treatment for four weeks. Dose: 1 tablet per day.
15948411|NCT03276572|Drug|225Ac-J591|225Ac-J591 (13.3 KBq/Kg - 93.3 KBq/Kg or 0.36 uCi/Kg - 2.52 uCi/Kg) on day 1
15948412|NCT03276559|Behavioral|EMPOWER|"EMPOWER is a manualized treatment delivered based in cognitive behavioral and acceptance and commitment therapies delivered by a trained mental health professional that utilizes breathing and grounding exercises, mindfulness meditation, psychoeducation, imaginal dialogue with the patient, and coping rehearsal techniques.
~The total amount of time EMPOWER intervention is about 90 minutes, about 15 minutes each module. It can either be administered in one session or many sessions to accommodate the dynamic nature of ICU, and has two booster follow-up calls (roughly 45 minutes each) in the month following initial treatment."
15948413|NCT03276559|Other|Enhanced Usual Care|Enhanced usual care consists of standard ICU psychosocial support for caregivers like social work, chaplaincy, or palliative care team visits as charted in the patient's medical record. Participants assigned to EUC will also receive a general information guide for caregivers as well as a site-specific list of caregiver resources.
15948414|NCT03276546|Behavioral|shared decision-making tool (SHARE-D)|questionnaire
15948415|NCT03276533|Drug|Saline|Participants in the group CON were received normal saline infusion until 30 min before the end of the operation.Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), at the end of the operation (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4)
15948416|NCT03276533|Drug|Lidocaine|Participants in the group LIDO received lidocaine infusion (1.5 mg/kg loading, 1.5 mg/kg/h infusion)until 30 min before the end of the operation.Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), at the end of the operation (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4)
15948417|NCT03276533|Drug|Dexmedetomidine|Participants in the group DEX received dexmedetomidine infusion (0.5 µg/kg loading, 0.4 µg/kg/h infusion) until 30 min before the end of the operation. Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), at the end of the operation (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4)
15948418|NCT03276533|Drug|Lidocaine plus Dexmedetomidine|Participants in the group LIDO+DEX were received lidocaine (1.5 mg/kg loading, 1.5 mg/kg/h infusion) and dexmedetomidine infusion (0.5 μg/kg loading, 0.4 μg/kg/h infusion) until 30 min before the end of the operation, respectively. Interleukin-6 and tumor necrosis factor-α levels in serum were measured at different time points: before administration of drugs (T1), at the end of the operation (T2), postoperative 2 hour (T3) and postoperative 24 hour (T4)
15948419|NCT03276520|Diagnostic Test|ethyl glucuronide|alcohol urine screening with ethyl glucuronide
15948420|NCT03276520|Diagnostic Test|ethanol|alcohol urine screening with ethanol
15948421|NCT03276507|Diagnostic Test|Pulmonary function studies|
15948422|NCT03276507|Diagnostic Test|Echocardiogram|
15948423|NCT03276507|Diagnostic Test|Electrocardiogram|
15948424|NCT03276507|Diagnostic Test|Chest radiography|
15948425|NCT03276507|Diagnostic Test|Blood test|
15948426|NCT03276507|Behavioral|Quality of life questionnaire|
15948427|NCT03276494|Device|Intraosseous|Intraosseous administration of hypertonic saline
15948428|NCT03276494|Drug|Hypertonic saline|Intraosseous administration of hypertonic saline
15948429|NCT03276481|Diagnostic Test|Oral microbiota assessment|Whole mouth microbiota will be assessed by having participants swish in their mouth 10 ml of sterile water for 30 sec and then expectorate in a sterile container. Specimens will be immediately placed on wet ice and transferred to the laboratory for processing or for storage at -80° C until they are ready to be prepared for sequencing.
15948430|NCT03276481|Diagnostic Test|Comprehensive chemical gustometry|Chemical gustometry assessments will be performed by a trained clinician on the study team, including a Registered Dietitian, Physician's Assistant, or Research Nurse. The test solutions and gradients will be formulated in house using sterile water and the following constituents: Sweet taste; 0.05, 0.1, and 0.2 g/ml sucrose, sour taste; 0.05, 0.09, and 0.165 g/ml citric acid, salty taste; 0.016, 0.04, and 0.1 g/ml NaCl and bitter taste; 0.0004, 0.0009, and 0.0024g/ml quinine-HCl. Umami will be tested with MSG at 25, 50, and 75 mM.
15948467|NCT03276091|Behavioral|Colofit+ intervention|Personnalized phone call, done by the medical student in the name of Adémas-69, organized cancers screening in the Rhône area association. This is a motivational call to encourage patients with an immunochemical fecal test positive, to realized their colonoscopy.
15948468|NCT03276078|Drug|Aclidinium Bromide/Formoterol Fumarate 400/12μg BID|Aclidinium bromide/formoterol fumarate 400/12μg administered by inhalation via the Genuair® multidose dry powder inhaler, twice daily (morning and evening) for 5 days
15948431|NCT03276481|Diagnostic Test|Measurement of salivary flow|Both stimulated and un-stimulated salivation will be assessed by saliva collection in pre-weighed plastic containers. Participants will be seated with their back at a 90 degree angle and asked to swallow everything in their mouth. They will then be asked not to swallow and spit the accumulated saliva in the plastic container every 30 seconds for two minutes (unstimulated flow). For measurement of stimulated saliva, we will follow the same procedure except that after the initial swallow, participants will have their tongue swabbed twice with a cotton swab dipped in ascorbic acid solution or lemon juice.
15948432|NCT03276481|Behavioral|Surveys assessing taste disturbances|Surveys will be administered and examine taste disturbances pre and post HCT.
15948433|NCT03276468|Drug|Atezolizumab|1200 mg on day 2 of each 21-day cycle during 18 months (24 cycles)
15948434|NCT03276468|Drug|Obinutuzumab|1000 mg on day 1, day 8 and day 15 of cycle 1 and each day 1 from cycle 2 to cycle 8
15948435|NCT03276468|Drug|Venetoclax|800 mg/d from day 8 of cycle 1, every day during 18 months. For MZL patients wiht lymphocytes>5 g/l : 50 mg/day: week 1 100mg/day: week 2 200mg/day: week 3 400mg/day: week 4 800mg/day: from week 5
15948436|NCT03276455|Genetic|Autologous CD34+ cells genetically modified|Autologous hematopoietic stem cell transduced with lentiviral vector encoding the therapeutic beta-globin gene. The target dose in the transduced product is 3x10^6 cells/Kg CD34+ cells, with a minimum dose of 2 x 10^6/Kg and a maximum dose of 20 x 10^6/Kg, depending on the yield of cells. The product will be injected intraosseously following intravenous BU ±Flu ±Cy.
15948437|NCT03276442|Other|Low-fat dietary intervention|Low-fat diet (5-7 days) preceding extended wakefulness under standardized conditions
15948438|NCT03276442|Other|High-fat dietary intervention|High-fat diet (5-7 days) preceding extended wakefulness under standardized conditions
15948439|NCT03276403|Device|PiCCO Catheter|The PiCCO Catheter is an investigational device intended to measure lung water content in individuals requiring advanced haemodynamic monitoring. The device system is to be used only in accordance with the approved Investigational Plan on subjects who have signed an informed consent form. Device use is limited to the approved study investigators.
15948440|NCT03276390|Behavioral|Hispanic Kidney Transplant Program (HKTP)|The HKTP entails culturally targeted education in Spanish about transplantation, outreach to dialysis patients by bicultural health care providers.
15948441|NCT03276364|Diagnostic Test|Ultrasound|Point-of-care ultrasound examination by pulmonary and critical care fellow
15948444|NCT03276338|Behavioral|HOLA|To increase condom use and HIV testing
15948445|NCT03276325|Drug|Placebo-nalbuphine|Epidural injection of normal saline followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5%
15948446|NCT03276325|Drug|Dexamethasone-nalbuphine|Epidural injection of dexamethasone followed with intrathecal injection of 0.6 mg nalbuphine in conjunction with 4 ml of hyperbaric bupivacaine 0.5%
15948447|NCT03276312|Device|Lipogems|Lipogems® is an innovative system that, starting from minimum quantities of autologous lipoaspirate, provides, with a minimal manipulation, a micro-fragmented and non-expanded adipose tissue product
15948448|NCT03276299|Other|six minute walking test|six minute walking test
15948449|NCT03276299|Other|six minute walking test|six minute walking test with encouragement
15948450|NCT03276286|Device|Nativis Voyager|Nativis Voyager treatment combined with standard of care radiotherapy and temozolomide
15948451|NCT03276273|Device|recording of Bispectral Index|recording of Bispectral Index
15948452|NCT03276260|Device|PMD-200|Patient will be connected to PMD-200 by finger-probe before induction of anesthesia or sedation. Recording will continue during surgery until extubation or awakening. Recording will be initiated again as soon as the patient arrives to the PACU until discharge to the surgical ward or home.
15948453|NCT03276247|Other|observation|observation
15948454|NCT03276221|Behavioral|Abstinence|Cannabis users randomized to this condition will be enrolled in a contingency management intervention for 30 days of cannabis abstinence.
15948455|NCT03276208|Other|Prenatal Massage|We will utilize moderate pressure Swedish massage (SM) that utilizes long slow strokes known as effleurage and kneading strokes known as petrissage. A specific routine will be performed on each participant with focus on low back, upper back, shoulders, and neck musculature. Consistent moderate pressure, which is lighter than deep tissue massage but deeper than brush strokes, will be used.
15948456|NCT03276208|Other|Mindfulness|The intervention and control group will be enrolled in the Craving to Quit® program, a 21-day mindfulness-based program delivered via a smartphone application (https://www.cravingtoquit.com/). This program uses a mindfulness-based approach to train people to recognize and be aware of their tobacco cravings. The program includes videos, online exercises to complete, and a virtual support community.
15948457|NCT03276182|Device|Lipiview 2|Tear film lipid layer thickness and meibomian gland dropout were measured by LipiView interferometer (TearScience Inc, Morrisville, NC)
15948458|NCT03276169|Procedure|Left atrial appendage closure|Left atrial appendage closure is performed using a single endocardial plug devices guided by fluoroscopic guidance and transesophageal echocardiography
15948459|NCT03276169|Procedure|Radiofrequency ablation|Each patient with persistent AF receives circumferential pulmonary vein isolation under the 3D electro-anatomical mapping system , and no additional ablation is performed in the extrapulmonary sites unless the patient is diagnosed with atrial flutter before the operation.
15948460|NCT03276169|Procedure|LAAC combined with radiofrequency ablation group|Each patient received the same group of patients with simple radiofrequency ablation radiofrequency ablation treatment at the same time, the transcatheter occlusion of left atrial appendage opening
15948461|NCT03276156|Drug|Apatinib plus S-1|Drug:Apatinib (425 mg/d) + S-1 (80mg to 120 mg);Drug:Apatinib (500 mg/d) + S-1 (80mg to 120 mg);Drug:Apatinib (675mg/d) + S-1 (80mg to 120 mg);Drug:Apatinib (750 mg/d) + S-1 (80mg to 120 mg);
15948462|NCT03276143|Drug|Enoxaparin|40 mg enoxaparin administered as subcutaneous injection once daily
15948463|NCT03276143|Drug|Apixaban|2.5 mg apixaban administered as tablet orally twice daily
15948464|NCT03276143|Drug|BAY1213790|Single dose of BAY1213790 administered as intravenous infusion
15948465|NCT03276104|Procedure|IOL repositioning|Intraocular lens repositioning by scleral suturing
15948469|NCT03276065|Device|Laser depilation|Fitzpatrick skin type classification will be assessed during the initial visit. The Fitzpatrick skin type classification is based on the level of pigmentation of the skin and its response to ultraviolet light (See Appendix). It will be used to select the best laser to perform hair removal for each patient. The laser treatment group will consist of an 810 nm (for Fitzpatrick skin types I-IV) or Nd:YAG (for Fitzpatrick skin types V-VI) 28 joule application at auto pulse duration for 400 ms. A cooling platform and application of 7% lidocaine/ 7% tetracaine cream, applied 45 minutes prior to treatment, will minimize any discomfort associated with the heat of the laser treatments.
15948470|NCT03276065|Other|Standard of care hair depilation|Patients and families in the standard of care group will be taught hair removal techniques and asked to perform either chemical or mechanical depilation as needed to keep the area hair-free. Patients will be given supplies for six months of hair removal.
15948471|NCT03276052|Drug|Aclidinium Bromide 200 μg|Aclidinium Bromide 200 μg BID inhalation powder. One oral inhalation via Genuair® dry powder inhaler (DPI)
15948472|NCT03276052|Drug|Aclidinium Bromide 400 μg|Aclidinium Bromide 400 μg BID inhalation powder. One oral inhalation via Genuair® dry powder inhaler (DPI)
15948473|NCT03276052|Drug|Aclidinium Bromide 800 μg|Aclidinium Bromide 400 μg BID inhalation powder. Two oral inhalations via Genuair® dry powder inhaler (DPI)
15948474|NCT03276039|Diagnostic Test|plasma pentraxin-3|Plasma pentraxin-3 was measured using ELISA
15948475|NCT03276026|Drug|Sugammadex|Sugammadex is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.
15948476|NCT03276026|Drug|Neostigmine|Neostigmine is used for the reversal of neuromuscular block in surgery that requires deep blockade to facilitate surgical procedures.
15948477|NCT03276013|Drug|Pembrolizumab|pembrolizumab in combination with doxorubicin
15948478|NCT03276000|Procedure|office hysteroscopy|A rigid 30 4-mm hysteroscope (Karl Storz Endoscopy) will be used without anaesthesia or analgesia 3 hours after administration of misoprostol. The uterine cavity will be distended with normal saline solution at a pressure of 100-120 mm Hg. The vaginoscopic ''no touch'' technique was followed; no speculum or tenaculum was used.
15948479|NCT03275987|Behavioral|Mammography direct mail coupled with a financial incentive|The intervention groups received innovative and persuasive direct mail materials coupled with an incentive for using their Medicaid benefit to get screened.
15948480|NCT03275987|Behavioral|Usual care|Group received usual care, and direct mail 15 months after treatment group received intervention.
15948481|NCT03275987|Behavioral|Colonoscopy direct mail coupled with a financial incentive|The intervention groups received innovative and persuasive direct mail materials coupled with an incentive for using their Medicaid benefit to get screened.
15948482|NCT03275974|Biological|Carbon C 11 Glutamine|Given by IV
15948483|NCT03275974|Biological|Fluorine F 18 L-glutamate Derivative BAY94-9392|Given by IV
15948484|NCT03275974|Procedure|Positron Emission Tomography|Undergo PET scan
15948485|NCT03275974|Procedure|Blood Draw|Undergo venous blood draws
15948486|NCT03275961|Behavioral|Stress Management and Resiliency Training|Subjects will undergo an 8 week behavioral program. Treatment will consist of weekly group therapy sessions in small groups with core practices to apply the principles of SMART.
15948487|NCT03275948|Other|whole grain|whole grain rye
15948488|NCT03275948|Other|reference|white wheat bread
15948489|NCT03275922|Drug|Placebo ZNS|Placebo Zolmitriptan Nasal Spray
15948490|NCT03275922|Drug|ZNS|Zolmitriptan Nasal Spray
15948491|NCT03275909|Behavioral|Integrated Psychological Therapy|The psychological treatment includes 50 sessions of integrated psychological therapy focused on attentional skills, social perception skills, verbal communication skills, social skills and interpersonal problems solving skills and 10 sessions of specific emotional management therapy , designed for this research. and based on the contents developed by Hodel, Kern and Brenner
15948492|NCT03275896|Other|Descemet Membrane Transplantation|The diseased host Descemet membrane will first be stripped, as per a standard Descemet Stripping Automated Endothelial Keratoplasty surgery. A cadaveric, acellular Descemet membrane graft will then be harvested and transplanted onto the host.
15948493|NCT03275883|Procedure|Aortohepatic Conduit|Placement of an interposition graft between hepatic artery and aorta during liver transplantation
15948494|NCT03275870|Drug|Hydroxychloroquine|Treatment of patients with hidradenitis suppurativa with hydroxychloroquine 200mg BID for 6 months
15948495|NCT03275857|Drug|Cisplatin|Weekly IV
15948496|NCT03275844|Procedure|Physical activity assessment|Assessment of Moderate-to-vigorous physical activity
15948499|NCT03275818|Drug|nab paclitaxel|Subjects in the DT cohort will receive a maximum of three cycles. Subjects in the DSRCT and ES cohort will receive unlimited cycles until disease progression, the subject begins a new anticancer treatment, withdrawal of parent/guardian/subject consent/assent, parent/guardian/subject refusal, physician decision, toxicity that cannot be managed by dose delay or dose reduction alone or the study ends for any reason
15948500|NCT03275805|Other|Duration of Pavlik Harness treatment|The only intervention that varies from standard of care (12 weeks of treatment) will be the duration of bracing (for the treatment to normalization arm). Patients in both arms will have identical follow up protocols and imaging to closely monitor hip morphology.
15948501|NCT03275805|Other|12 week standard of care|The intervention for this arm will be standard treatment for this pathology.
15948502|NCT03275792|Drug|D5-0.9%NS|Admission for intravascular volume expansion
15948503|NCT03275792|Drug|Routine home oral rehydration|Routine oral fluids as is given at home to all children with acute diarrheal disease
15948504|NCT03275779|Behavioral|Low Frequency Condition|Young, untrained participants complete 7 days of habitual physical activity followed by a 7 day period where participants complete a single bout of unilateral resistance exercise.
15948505|NCT03275779|Behavioral|High Frequency Condition|Young, untrained participants complete 7 days of habitual physical activity followed by a 7 day period where participants complete the same total volume of resistance exercise as the low frequency condition as five smaller bouts of unilateral resistance exercise.
15948506|NCT03275766|Other|DLPFC facilitatory|15 Hz stimulation of left dorsolateral prefrontal cortex (DLPFC)(15 sessions/3weeks, 1500 stimuli per session, stimulation intensity 100% of the individual active motor threshold; in total 22500 stimuli
15948508|NCT03275766|Other|SMA facilitatory|Three pulses of stimulation at 50 Hz of preSMA/SMA, repeated every 200 ms. 2 s trains are repeated every 10 s for a total of 190 s (600 pulses, 200 seconds). intensity 80% of individual active motor threshold; in total 9000 stimuli
15948509|NCT03275766|Other|sham TMS|Determination of active motor threshold and subsequent stimulation with the placebo coil, with the same sounds but without effects. 15 sessions in three weeks, duration of 20 mins per session
15948510|NCT03275753|Other|Visual Function Tests|All subjects will undergo a battery of visual function tests
15948511|NCT03275740|Drug|PF-06755347 intravenous|Single doses of PF-06755347 will be administered intravenously dose levels 1, 2, 3, 4, 5, and 6.
15948512|NCT03275740|Drug|Placebo intravenous|Placebo comparator
15948513|NCT03275740|Drug|PF-06755347 subcutaneous|single doses of PF-06755347 will be administered subcutaneously at dose levels of SC1, SC2, SC3, SC4, and SC5.
15948514|NCT03275740|Drug|Placebo subcutaneous|placebo comparator
15948515|NCT03275727|Behavioral|iACT-BC|A Guided INternet-delivered Individually-tailored ACT-influenced Cognitive Behavioural INtervention to ImprOVe Psychosocial Outcomes in Breast Cancer Survivors
15948516|NCT03275714|Device|Smartphone APP|Participants use the BiP-App for 6 months. The app continuously records data on light and motion sensors, as well as Global Positioning System (GPS) and mood surveys.
15948517|NCT03275701|Drug|Triumeq|Open Label, Switch to Triumeq (ABC/DTG/3TC)
15948518|NCT03275688|Diagnostic Test|Breath Analysis|Breath will be analyzed in all three groups using gas chromatography mass spectrometry.
15948519|NCT03275675|Drug|Oral anticancer medications|All the oral medications for cancer treatment (hormonal, cytotoxic and targeted therapies)
15948520|NCT03275662|Behavioral|Dietary Fiber|
15948521|NCT03275662|Behavioral|Fermented Foods|
15948522|NCT03275649|Other|Help-seeking for non-motor symptoms|Brief, self-paced, online individually tailored intervention using LifeGuide software. Includes information, videos and exercises.
15948523|NCT03275636|Biological|Peripheral blood stem cells|Hematopoietic stem cell transplantation with PBSC
15948524|NCT03275623|Drug|Antibiotic|Those randomized for treatment will be prescribed the most commonly used antibiotic for urinary tract infections in pregnancy. This includes: Nitrofurantoin, Cephalexin, and Amoxicillin. It is unsure which antibiotic the participant will receive but a majority of the time it will be one of the above named antibiotic. The choice will be determined by the physician, but will accommodate participants' prior medication history and adverse events.
15948525|NCT03275623|Other|Standard Prenatal Care|Continued surveillance of urinary cultures
15948526|NCT03275610|Genetic|Blood sample|5 mL of blood withdrawn from patients with history of pulmonary embolism post total hip arthroplasty or total joint arthroplasty
15948527|NCT03275597|Drug|Durvalumab|Durvalumab is an FDA-approved immunotherapy for cancer. Durvalumab is a human monoclonal antibody (mAb) of the immunoglobulin G (IgG) 1 kappa subclass that inhibits binding of PD-L1 and is being developed by AstraZeneca/MedImmune for use in the treatment of cancer.
15948528|NCT03275597|Drug|Tremelimumab|Tremelimumab is a monoclonal antibody against CTLA-4. It is an IgG 2 kappa isotype mAb directed against the cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) also known as CD152 (cluster of differentiation 152). This is an immunomodulatory therapy (IMT) that is being developed by AstraZeneca for use in the treatment of cancer.
15948529|NCT03275597|Radiation|Stereotactic Body Radiotherapy|SBRT is a highly conformal approach to the delivery of radiation therapy, maximizing radiation dose to the tumor while minimizing dose to nearby normal tissues.
15948530|NCT03275584|Drug|N-13 ammonia intravenous injection|"Participants will receive two injections of N-13 ammonia, once at rest and once at stress before undergoing positron emission tomography myocardial perfusion imaging"
15948531|NCT03275571|Behavioral|cCBT intervention|During each 30 minutes sessions, the participants will learn key concepts on depression, then will apply them to the program's main character who suffers from depression, and then will apply those techniques to their own personal challenges.
15948532|NCT03275558|Drug|Axitinib 1 MG|"Pharmaceutical composition of Axitinib 5MG +Sunitinib 5MG + Pazopanib 5MG in the liquid form of a nasal spray NST-4-G.
~Subjects take a nasal spray BID at a single dose in each nostril (approximately at the same time of day) for 7 weeks or unacceptable toxicity or other adverse events."
15948533|NCT03275558|Drug|Sunitinib 5 MG|Pharmaceutical composition of Axitinib 5MG +Sunitinib 5MG + Pazopanib 5MG in the liquid form of a nasal spray NST-4-G.
15948534|NCT03275558|Drug|Pazopanib 5 MG|Pharmaceutical composition of Axitinib 5MG +Sunitinib 5MG + Pazopanib 5MG in the liquid form of a nasal spray NST-4-G.
15948535|NCT03275545|Other|No intervention|No intervention is being examined in this study
15948536|NCT03275519|Other|Randomization to not receive prophylactic antibiotics after surgery.|No antibiotics were ordered after surgery.
15948537|NCT03275519|Other|Randomization to receive prophylactic antibiotics after surgery|In general, the antibiotic given is a combination sulfamethoxazole/ trimethoprim oral suspension (2-3 mg trimethoprim/kg by mouth once a day); or if indicated, nitrofurantoin (1mg/kg by mouth once daily). All subjects did not receive intraoperative antibiotics.
15948538|NCT03275506|Drug|Pembrolizumab Injectable Product - Chemotherapy - Bevacizumab|Pembrolizumab 200 mg then carboplatin (AUC5 or 6) and paclitaxel (175mg/m²), +/- bevacizumab (15 mg/kg Q3W)
15948539|NCT03275506|Drug|Chemotherapy - Bevacizumab|Carboplatin (AUC5 or 6) and paclitaxel (175mg/m²), +/- bevacizumab (15 mg/kg Q3W)
15948540|NCT03275493|Biological|Humanized CD19 CAR-T cells|Express a Second Generation 4-1BB:humanized CD19 CAR-T cells
15948541|NCT03275493|Biological|Humanized CD19 CAR-T cells with CRS suppression technology|Express a Second Generation 4-1BB:humanized CD19 CAR-T cells with CRS suppression technology
15948542|NCT03275467|Other|Faecal microbiota transfer (FMT)|Suspended stool from a healthy donor
15948543|NCT03275454|Drug|BIVV009 6.5 grams|Participants who weigh less than 75 kilogram (kg) will receive fixed doses of 6.5 grams of BIVV009.
15948544|NCT03275454|Drug|BIVV009 7.5 grams|Participants who weigh 75 kg or more will receive fixed doses of 7.5 grams of BIVV009.
15948545|NCT03275441|Diagnostic Test|Electroretinography|An additional electroretinogram performed after 10 minutes of dark adaptation.
15948546|NCT03275428|Device|transnasal humidified rapid-insufflation ventilator exchange|high flow nasal cannula with humidified oxygen
15948653|NCT03274648|Dietary Supplement|Habitual diet|Patients follow the habitual diet
15948547|NCT03275415|Drug|budesonide|Intra-tracheal instillation of a combination of budesonide/surfactant in preterm infants with RDS to prevent BPD
15948548|NCT03275415|Drug|Saline|Intra-tracheal instillation of a combination of saline/surfactant in preterm infants with RDS to prevent BPD
15948549|NCT03275402|Biological|131I-omburtamab|Murine IgG1 monoclonal antibody radiolabeled with iodine-131
15948550|NCT03275389|Biological|D-SUIV cH8/1N1+AS03|1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH8/1N1 with Adjuvant System 03 (AS03) was administered intramuscularly (IM) in the deltoid region of non-dominant arm.
15948551|NCT03275389|Biological|D-SUIV cH5/1N1+AS03|1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH5/1N1 with Adjuvant System 03 (AS03) was administered IM in the deltoid region of non-dominant arm.
15948552|NCT03275389|Biological|D-SUIV cH11/1N1+AS03|1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH11/1N1 with Adjuvant System 03 (AS03) was administered IM in the deltoid region of non-dominant arm.
15948553|NCT03275389|Biological|D-SUIV cH8/1N1+AS01|1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH8/1N1 with Adjuvant System 01 (AS01) was administered IM in the deltoid region of non-dominant arm.
15948554|NCT03275389|Biological|D-SUIV cH5/1N1+AS01|1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH5/1N1 with Adjuvant System 01 (AS01) was administered IM in the deltoid region of non-dominant arm.
15948555|NCT03275389|Biological|D-SUIV cH11/1N1+AS01|1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH11/1N1 with Adjuvant System 01 (AS01) was administered IM in the deltoid region of non-dominant arm.
15948556|NCT03275389|Biological|D-SUIV cH8/1N1|1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH8/1N1 without adjuvant was administered IM in the deltoid region of non-dominant arm.
15948557|NCT03275389|Biological|D-SUIV cH5/1N1|1 Primary dose or 1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH5/1N1 without adjuvant was administered IM in the deltoid region of non-dominant arm.
15948558|NCT03275389|Biological|D-SUIV cH11/1N1|1 Booster dose of Supraseasonal Universal Influenza Vaccine (Flu D-SUIV), chimeric strain cH11/1N1 without adjuvant was administered IM in the deltoid region of non-dominant arm.
15948559|NCT03275389|Biological|Placebo|1 dose of Phosphate Buffered Saline (PBS) was administered IM in the deltoid region of non-dominant arm.
15948560|NCT03275389|Biological|Fluarix Quadrivalent|1 Primary dose and 1 Booster dose was administered IM in the deltoid region of non-dominant arm.
15948561|NCT03275376|Drug|Atorvastatin 10mg|Atorvastatin or placebo will be administered according to randomized allocations.
15948562|NCT03275376|Drug|Placebo Oral Tablet|Atorvastatin or placebo will be administered according to randomized allocations.
15948563|NCT03275363|Diagnostic Test|Neurocognitive battery|"Cognitive impairment status (SCD, MCI, dementia), HK-MoCA, Clinical Dementia Rating (CDR sum of squares), Geriatric Depression Scale (GDS-15), Neuropsychiatric Index (NPI), Barthel Index, Lawton's IADL, Life-Space Assessment, Mini-Nutrition Assessment (MNA), Quality of Life for Alzheimer's Disease (QoL-AD, patient and carer parts), frailty status (FRAIL scale), handgrip strength, walking speed, exercise status, sleep quality, Charlson comorbidity index (CCI, age-adjusted).
~NACC: Story recall, Benson's complex figure copy, colour trail test (black & white), verbal fluency, digit forward and backward span."
15948564|NCT03275363|Diagnostic Test|MRI|MRI: T1, T2, FLAIR, SWI, DTI, fMRI, ASL, MRS, for selected patients
15948565|NCT03275363|Biological|Blood tests|Stored samples (unanalysed): serum, plasma, buffy coat (PBMC); also processed for microvesicles and exosome analysis
15948566|NCT03275363|Diagnostic Test|EEG with event-related potential (ERP)|128-channel EEG with ERP for Go/NoGo and Prospective Memory (PM) tasks for selected patients
15948567|NCT03275363|Diagnostic Test|Amyloid PET CT|F18 Flutametamol PET CT for selected patients
15948568|NCT03275350|Drug|Naltrexone Injectable Suspension|Six monthly injections of extended-release naltrexone
15948569|NCT03275350|Other|Treatment as usual|Standard treatment for opioid use disorder provided at each HIV clinic
15948570|NCT03275337|Device|Transcranial Direct Current Stimulation|tDCS is a non-invasive form of neuromodulation in which direct current is administered placed over a brain region of interest to induce physiological changes such as inhibition or excitation over that region.
15948571|NCT03275324|Device|Capnostream20p|Observational study of patients connected to the Capnostream20p monitor.
15948572|NCT03275285|Drug|isatuximab SAR650984|"Pharmaceutical form: solution for infusion
~Route of administration: intravenous"
15948573|NCT03275285|Drug|carfilzomib|"Pharmaceutical form: solution for infusion
~Route of administration: intravenous"
15948574|NCT03275285|Drug|dexamethasone|"Pharmaceutical form: tablets or solution for infusion
~Route of administration: oral or intravenous"
15948575|NCT03275272|Diagnostic Test|level of IGF-1 in infants|Measurment of blood level of IGF-1 in infants
15948576|NCT03275259|Device|THORK Shock Wave® (Extracorporeal shock waves)|Treatment with extracorporeal shock waves: energy between 100 and 180mJ, frequency of 15Hz and 6000 shots in abdomen, glutes and thigh Back and flanks 3000 shots with radial applicator and 15mm tip. The treatment is performed twice a week for 1 hour and 30 minutes each session.
15948577|NCT03275246|Device|X-PSI Knee System|Patients are operated with X-PSI Knee System guides
15948578|NCT03275220|Diagnostic Test|2D Echocardiography and 3D Echocardiography|Imaging of right ventricle by 2d echocardiography and 3D echocardiography to assess right ventricular function accurately
15948579|NCT03275207|Drug|saline|an equal volume of saline
15948580|NCT03275207|Drug|dexmedetomidine|dexmedetomidine, 0.5ug/kg/h by intravenous infusion, intraoperative
15948581|NCT03275194|Procedure|HIPEC|Following complete cytoreductive surgery without any evidence of residual disease, the patient will be randomized either HIPEC (intervention) or no-HIPEC (control) in the operative Room. If the arm HIPEC is obtained, then a HIPEC procedure with cisplatin and doxorubicin will be performed. If no-HIPEC (control arm) is assigned then the surgical procedure will be finished.
15948582|NCT03275181|Diagnostic Test|Transthoracic Echocardiography|Non-invasive assessment of left ventricle structure and function
15948583|NCT03275181|Diagnostic Test|Arterial blood pressure|Continuously monitored for 5-30 minutes via finger photoplethysmography
15948584|NCT03275181|Diagnostic Test|Submaximal Exercise|Incremental exercise test to 85% predicted maximal heart rate on a recumbent cycle ergometer
15948585|NCT03275168|Behavioral|Intervention|Sexual partners will receive dyadic counseling and support for condom negotiation after receipt of individual evidence based HIV/STI prevention intervention (Sister-to-Sister (female) and Focus on the Future (male).
15948586|NCT03275168|Behavioral|Individual evidence-based STI/HIV prevention intervention|Sexual partners will receive individual evidence-based HIV/STI prevention counseling without partner debrief and/or practice negotiating condom use.
15948587|NCT03275142|Device|Icare tonometer|Icare tonometry effects of keratometry readings, topography, and corneal staining to demonstrate that the Icare tonometer does not alter subsequent evaluation or testing. This would allow IOP testing to be performed by technical staff at any time during the examination process without affecting subsequent tests. A total of fifteen patients at each of four sites will be evaluated using Icare tonometers provided by Icare USA. The investigator will be masked as to which eye will undergo Icare tonometry. Both the study eye and the control eye will undergo pre-tonometry and post-tonometry testing; Keratometry readings, IOL master, Topography via Pentacam, and corneal staining with fluorescein using the Oxford scoring scale.
15948588|NCT03275129|Diagnostic Test|Ultrasound assessment of heart and lungs|Patients will receive an ultrasound assessment of their heart and lungs.
15948589|NCT03275116|Drug|Tiotropium 'Respimat' 5 mcg|Once daily single bronchodilation
15948590|NCT03275116|Drug|Aclidinium Bromide/Formoterol Fumarate 340/12 mcg|Twice daily dual bronchodilation
15948593|NCT03275090|Drug|Smoflipid ®|
15948594|NCT03275077|Device|Thromboelastography|A viscoelastic test of coagulation
15948595|NCT03275064|Biological|LNA043|LNA043 intra-articular injection
15948596|NCT03275064|Other|Placebo|Placebo intra-articular injection
15948597|NCT03275051|Other|Safety and Efficacy assessments|Safety and efficacy assessment of OTL-300 in subjects with transfusion dependent beta-thalassemia will be performed.
15948598|NCT03275038|Behavioral|Tai-Chi exercise|Behavioral: Tai-Chi exercise
15948599|NCT03275038|Behavioral|Aerobic exercise|Behavioral: Aerobic exercise
15948600|NCT03275025|Drug|YRA-1909 low dose|A low dose of YRA-1909; daily oral intake for 12 weeks
15948601|NCT03275025|Drug|YRA-1909 mid dose|A mid dose of YRA-1909; daily oral intake for 12 weeks
15948602|NCT03275025|Drug|YRA-1909 high dose|A high dose of YRA-1909; daily oral intake for 12 weeks
15948603|NCT03275025|Drug|Placebo|Matching placebo dosing with daily oral intake for 12 weeks
15948604|NCT03275012|Drug|Gabapentin + Morphine|"Gabapentin: liquid oral formulation (syrup) - 75 mg/ml-three times daily. The starting dose during the optimization period will be defined according to 2 weight groups (5-15kg and >15kg). Dose will be scaled at Day 1,3,5,14,and 21 according to a specific schedule. Maintenance dosing will be scheduled in accordance to the body weight.
~Morphine: background therapy as oral, liquid and solid formulations. Patients with BW≤30kg :liquid oral formulation four times daily throughout the whole treatment period. Patients with BM>30kg : immediate release solid and/or liquid oral formulation four times daily during titration phase and an extended release solid oral formulation twice daily during the maintenance period."
15948605|NCT03275012|Drug|Placebo + Morphine|Placebo liquid oral formulation. Morphine: background therapy as oral, liquid and solid formulations. Patients with BW≤30kg :liquid oral formulation four times daily throughout the whole treatment period. Patients with BM>30kg : immediate release solid and/or liquid oral formulation four times daily during titration phase and an extended release solid oral formulation twice daily during the maintenance period.
15948606|NCT03274999|Device|TrueTear™ Application|Intranasal and extranasal application of TrueTear™ device for approximately 3 minutes at Day 0 and Day 14.
15948607|NCT03274986|Device|ACRYSOF® IQ Extended Depth of Focus IOL|Implantable IOL intending to extend the depth of focus and provide continuous functional vision from distance to near while maintaining distance vision and a visual disturbance profile comparable to a monofocal IOL.
15948608|NCT03274986|Device|ACRYSOF® IQ Monofocal IOL|Monofocal IOL implanted for long-term use over the lifetime of the pseudophakic subject
15948609|NCT03274986|Procedure|Cataract surgery|IOL bilateral implantation
15948610|NCT03274973|Drug|Zomacton|Injection
15948611|NCT03274960|Combination Product|Griess,|Experimental: Griess, Culture and antibiotic Griess reagents, sulfanilamide and NED added in urine sample for 20 minutes, urine culture using blood agar for 24 hours and treatment with antibiotic every trimester for up to 7 days.
15948612|NCT03274947|Device|Cerebellar TMS|Cerebellar transcranial magnetic stimulation
15948613|NCT03274947|Device|Sham cerebellar TMS|Sham cerebellar transcranial magnetic stimulation
15948614|NCT03274934|Behavioral|Experimental: face-to-face and online support group:|5-week intervention according to Acceptance and Commitment Therapy principles with the web-and mobile-based Youth COMPASS program, face-to-face support (2 meetings) and weekly online mobile support and feedback from the individually assigned coach (one third of the participants is randomly assigned to this group)
15948615|NCT03274934|Behavioral|Experimental: only online support group:|5-week intervention according to ACT principles with the web-and mobile-based Youth COMPASS program, no face-to-face support, weekly mobile online support and feedback from the individually assigned coach (one third of the participants is randomly assigned to this group)
15948616|NCT03274934|Behavioral|Control|Control group, no intervention, school counseling as usual. (one third of the participants is randomly assigned to this group)
15948617|NCT03274921|Diagnostic Test|Biological determination|Evaluation of plasma accumulation of the 10 retention solutes with CV complications in CKD patients
15948618|NCT03274908|Other|regular medical treatment|regular medical treatment
15948619|NCT03274895|Drug|PHMB 0.08%|16 drops in a day for 5 days,8 drops in a day for 7 days,6 drops in a day for 7 days and 4 drops in a day up to clinical resolution
15948620|NCT03274895|Drug|Propamidine 0.1%|16 drops in a day for 5 days,8 drops in a day for 7 days,6 drops in a day for 7 days and 4 drops in a day up to clinical resolution
15948621|NCT03274895|Drug|placebo|16 drops in a day for 5 days,8 drops in a day for 7 days,6 drops in a day for 7 days and 4 drops in a day up to clinical resolution
15948622|NCT03274895|Drug|PHMB 0.02%|16 drops in a day for 5 days,8 drops in a day for 7 days,6 drops in a day for 7 days and 4 drops in a day up to clinical resolution
15948623|NCT03274882|Drug|S95005|The treatment is given in open manner. It was administered until unacceptable toxicity according to the investigator, disease progression or patient withdrawal. If a patient discontinues study treatment for reasons other than radiologic disease progression (e.g., intolerable side effects), the patient was followed for tumour response until radiologic disease progression or initiation of new anticancer therapy (whichever occurs first).
15948624|NCT03274869|Other|No intervention|No intervention
15948625|NCT03274856|Drug|GLWL-01|Oral administration of 3 capsules, twice a day
15948626|NCT03274856|Drug|Placebo|Oral administration of 3 capsules, twice a day
15948627|NCT03274843|Other|Activity of everyday life|Kitchen workshop
15948628|NCT03274830|Device|aneXys|150 patients with the aneXys cup
15948629|NCT03274817|Drug|Escitalopram Pill|Subjects randomized to group A will receive Lexapro (escitalopram), in an initial, baseline dosage of 5 mg daily.
15948630|NCT03274817|Drug|Venlafaxine Pill|Subjects randomized to group B will receive Effexor XR (venlafaxine extended release capsules), in an initial baseline dosage of 37.5 mg daily.
15948631|NCT03274817|Drug|Placebo Oral Tablet|Subjects randomized to group C will receive placebo tablets, which will be matched to the Lexapro and the Effexor XR as far as possible, and will also be administered on a once daily schedule at baseline.
15948632|NCT03274804|Biological|Pembrolizumab|Eligible subjects will receive pembrolizumab beginning on Day 1 of each 3-week dosing cycle (d1, qd22)
15948633|NCT03274804|Drug|Maraviroc|Maraviroc will be administered perorally on day 1 to 21 of each cycle (d1-21; qd22)
15948634|NCT03274791|Diagnostic Test|Analysis of induced sputum|"Induced sputum was collected and analysed in the three arms (Healthy subjects, Never smokers with COPD and smokers with COPD) The volume of the sputum sample, was treated with an equal volume of 0.1% dithiothreitol. The samples were then vortexed and placed in a shaking water bath at 37°C for 15 min to ensure complete homogeneisation. The suspensions were centrifuged at 400× g and the sputum supernatant stored at -80°C until cytokines analysis. The cell pellet was resuspended in 0.5% bovine serum albumin in phosphate buffered saline and cytospin were made by putting 100 µL of the cell suspension in the funnels.
~Slides for differential cell counts were stained with May-Grünwald Giemsa."
15948635|NCT03274791|Diagnostic Test|Lung Function test|"All the subjects underwent pulmonary function tests (Healthy subjects, Never smokers with COPD and smokers with COPD).
~Pulmonary function parameters were measured using a portable spirometer (Easy One ndd. Medizintechnik; Zurich, Switzerland) according to the ATS criteria (American Thoracic Society). Reversibility test was performed 15 min after inhalation of 400 µg of Salbutamol (Ventolin, GlaxoSmithKline, Middlesex, UK). All spirometry data were graded for quality and only tests that met high quality scores were used for the final analysis."
15948636|NCT03274791|Diagnostic Test|Enzyme-linked Immunosorbent Assay|"IL-8 and TNF-α were measured in the sputum supernatant of all the subjects (Healthy subjects, Never smokers with COPD and smokers with COPD).
~Commercially available kits were used to detect IL-8 (Human IL-8 Immuno-Biological Laboratories ELISA Kit) and TNF-α (Human TNF-alpha Sigma-Aldrich ELISA Kit) concentrations in the sputum supernatants. The absorbance was measured at 450 nm. The lower limits detection were 2 pg/mL for IL-8 and 5 pg/mL for TNF-α. The intra assay coefficients of variability were 8.7% for IL-8 and 7.7% for TNF- α."
15948637|NCT03274778|Drug|Ruxolitinib 20 MG|tablets
15948638|NCT03274765|Diagnostic Test|Dosage of oestradiol|"The study is based on a concept using capillary blood tests using lateral flow by migration on membrane similarly to a pregnancy test, patented by a french company (NGBiotech).
~This study is therefore a feasibility study of a rapid test for oestradiol dosage during monitoring of ovarian stimulation."
15948639|NCT03274752|Drug|Paroxetine|Paroxetine (Deroxat) will be administered in a dosage of 20mg q.d. per os continuously for 12 weeks after primary PCI. In week 13, Paroxetine (Deroxat) will be administered in a dosage of 10mg q.d. per os.
15948640|NCT03274752|Drug|Placebo oral capsule|Placebo will be given q.d. per os continuously for 12 weeks after primary PCI. In addition, a placebo will be given q.d. per os in week 13 as well.
15948641|NCT03274713|Device|Electro-acupuncture|"Patients in this group will be treated by use of 6-7 local acupuncture points (ST34, ST35, ST36, EX-LE2, EX-LE5, GB33, GB34, SP9, SP10, LR7, LR8 and Ashi) and 2-3 distal points (GB31, GB36, GB39, GB41, ST40, ST41, LR3, BL60, SP6 and KI3). Needles will be stimulated manually for 10 seconds to achieve De Qi sensation and an electrical apparatus (HANS-200A acupoint nerve stimulator, Nanjing Jisheng Medical Co., Ltd. production, wave of 2/100Hz) will be then connected to the needles with alligator clips to stimulate the needles in pairs ST36-SP9/GB34 and ST34-SP10. The stimulus intensity will be increased until the patient reports a strong but comfortable intensity."
15948642|NCT03274713|Device|Manual acupuncture|Participants in the group have the same schedule as the electro-acupuncture group except that the electrical apparatus has working power indicator and sound without actual current output.
15948643|NCT03274700|Drug|Tamsulosin.|Patients who will receive tamsulosin as a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration.
15948644|NCT03274700|Drug|Placebo.|Patients who will receive as placebo a treatment for lower ureteric stones from (10-15)mm up to 8 weeks duration.
15948645|NCT03274687|Radiation|Hypofractionated Radiation Therapy|Undergo hypofractionated radiation therapy
15948646|NCT03274687|Other|Laboratory Biomarker Analysis|Correlative studies
15948647|NCT03274687|Other|Quality-of-Life Assessment|Ancillary studies
15948648|NCT03274687|Radiation|Radiation Therapy|Undergo conventional radiation therapy
15948649|NCT03274674|Other|I-PRF|Venous blood will be taken from the patient every session and I-PRF will be created in the centrifuge.I-PRF injected on one side of bilateral thin gingival thickness.Microneedle application plus I-PRF injected on the other side in patients with bilateral region with thin gingival phenotype.Apply once a week and one month after the end of the injections, the patient will be called to the control.
15948650|NCT03274661|Drug|Pembrolizumab 200 mg Q3W|Pembrolizumab 200 mg Intravenous Infusion every 3 weeks administered on Day 1 of each 3 week cycle
15948651|NCT03274648|Dietary Supplement|Oral butyrate|Patients follow the habitual diet supplemented with 2.4g/day of oral butyrate
15948652|NCT03274648|Dietary Supplement|Vegetarian diet|Patients follow a vegetarian diet containing inulin and resistant starch-rich foods, including no meat and fish, but containing eggs and dairy products
15948654|NCT03274635|Behavioral|Desk-based pedaling device and pedaling incentives provided|Varying types of incentives, equivalent in monetary value, will be randomly assigned across the 6 arms to promote regular desk-based pedaling. A free desk-based pedaling device will be provided. Effects on amount of desk-based pedaling and work productivity will be evaluated.
15948655|NCT03274622|Behavioral|Impact Parent Training|
15948656|NCT03274622|Behavioral|No Impact|
15948657|NCT03274609|Combination Product|Augmented fluoroscopy|Augmented fluoroscopy based virtual navigation combined with use of radial EBUS probe and Rapid On Site Evaluation of Histology for diagnosis of peripheral pulmonary nodules.Controlled by cone beam CT.
15948658|NCT03274596|Drug|Vitamin E|
15948659|NCT03274596|Drug|Placebo|
15948660|NCT03274583|Diagnostic Test|Smartphone seismographic recording|A short recording of heart rhythm using a smartphone.
15948661|NCT03274557|Procedure|RFM|
15948662|NCT03274544|Other|PROLUNG|"Chinese herbal medicine formula PROLUNG with individual herbs of the formula are listed as follows (weight in granule preparation):
~Huang Qi (Radix Astragali Membranaceus): 2 g
~Dan Shen (Radix Salviae Miltiorrhizae): 1 g
~Jiang Huang (Rhizoma Curcumae Longae): 1 g
~Yin Xing (Semen Gingko Bilobae): 1 g
~Mai Men Dong (Tuber Ophiopogonis Japonoci): 1 g
~Bai He (Bulbus Lilii): 1g
~Jin Yin Hua (Flos Lonicerae Japonicae): 1 g
~Zi Su Ye (Folium Perillae Frutescentis): 1 g
~Yin Yang Huo (Herba Epimedii): 1g"
15948663|NCT03274531|Behavioral|Referral of hypertensive patients to the attending physician|Immediate referral to the treating physician in case of elevated automated office blood pressure measurements
15948664|NCT03274518|Device|Expanded Hemodialysis|"Intervention: Conversion from conventional HD to expanded hemodialysis por 1 month.
~High cutoff with high retention onset dialyzers allow clearance of middle molecules, without reducing significantly serum concentration of albumin. It allows higher convective clearance in comparison to conventional hemodialysis, but it is unknown if such clearance is similar to online hemodiafiltration. Therefore, the aim of the present intervention is to compare this dialyzer with online hemodiafiltration"
15948665|NCT03274518|Device|Online Hemodiafiltration|"Intervention: Conversion from conventional HD to online Hemodiafiltration por 1 month.
~Online hemodiafiltration has been associated with lower incidence of intradialytic hypotension in comparison to conventional hemodialysis."
15948666|NCT03274505|Other|Questionnaires|"Questionnaires about excessive daytime sleepiness (Epworth scale), insomnia (Severity of Insomnia Scale), Restless Legs Syndrome, Chronotype (Horne and Ostberg questionnaire), Sleep apnoea syndrome (Berlin questionnaire)
~Clinical evaluation
~Routine neuropsychological evaluation (for stroke patients)
~Routine Polysomnography for patients with high suspicion of sleep apnoea syndrome (SOS score (Epworth + Berlin) > 10)"
15948667|NCT03274492|Drug|Polatuzumab Vedotin|Polatuzumab vedotin IV infusion will be administered as per the schedule specified in the respective arm.
15948668|NCT03274492|Drug|Rituximab|Rituximab IV infusion will be administered as per the schedule specified in the respective arm.
15948669|NCT03274492|Drug|Cyclophosphamide|Cyclophosphamide IV infusion will be administered as per the schedule specified in the respective arm.
15948670|NCT03274492|Drug|Doxorubicin|Doxorubicin IV infusion will be administered as per the schedule specified in the respective arm.
15948671|NCT03274492|Drug|Vincristine|Vincristine IV infusion will be administered as per the schedule specified in the respective arm.
15948672|NCT03274492|Drug|Vincristine Placebo|Placebo matching to vincristine will be administered as per the schedule specified in the respective arm.
15948673|NCT03274492|Drug|Prednisone|Prednisone PO will be administered as per the schedule specified in the respective arm.
15948674|NCT03274492|Drug|Polatuzumab vedotin Placebo|Placebo matching to polatuzumab vedotin will be administered as per the schedule specified in the respective arm.
15948675|NCT03274479|Drug|PBF-1129|PBF-1129 once a day by oral administration
15948676|NCT03274466|Device|Closed Incision Negative Pressure Therapy (ciNPT)|Closed Incision Negative Pressure Therapy applied through a foam bolster with a wicking interface fabric that includes 0.019% ionic silver at 125 mmHg of negative pressure for 5-7 days.
15948677|NCT03274466|Device|Standard of Care Dressing|A standard silver-impregnated dressing applied to a closed surgical incision for 5-7 days post-operatively.
15948678|NCT03274453|Drug|Ketamine|0.12 mg/kg/hr of ketamine post surgery
15948679|NCT03274453|Drug|Saline|Saline will be administered at the same rate as the ketamine infusion.
15948680|NCT03274440|Drug|Cannabis|"THC and CBD are cannabinoids which are found naturally in the marijuana plant. Both act on the brain's endocannabinoid system, which has been hypothesized to play a role in OCD."
15948681|NCT03274440|Other|Placebo|Placebo control group, not receiving THC or CBD.
15948682|NCT03274427|Device|Basic drugs therapy of HCC by TACE|Basic drugs include: 1. Molecular targeted drugs for HCC：apatinib; 2. Antiviral drugs (ETV or TDF) should be given to patients who were infected with HBV or HCV; 3. Patients with liver dysfunction should be treated with conventional hepatoprotective agents drugs (including glycyrrhizin, reduced glutathione, vitamin C，etc); 4. Patients with ascites symptoms should be treated with furosemide and spironolactone according to the urine volume, and they also should be treated with proton pump inhibitors in the prevention of gastrointestinal bleeding; 5. Other basic diseases were treated routinely.
15948683|NCT03274427|Drug|Arginine hydrochloride|Arginine hydrochloride injection 5g/dose; 40g/d; ivgtt; sustained medication for 24 days; drug withdrawal for 4 days.
15948684|NCT03274427|Drug|Trimetazidine hydrochloride|Trimetazidine hydrochloride, 20mg/tablet, 40mg, twice a day.
15948685|NCT03274414|Drug|Cisplatin|Cisplatin should be administered on day 1 (+/- 3 days) of the start of radiotherapy and then every 3 weeks (unless there is a delay for safety concerns such as neutropenia) for a total of 3 cycles. 100 mg/m^2 (dose reductions after the first cycle allowed for toxicity)
15948686|NCT03274414|Radiation|Adjuvant Proton Radiotherapy|"Proton therapy treatment will follow the National Cancer Institute's Guidelines for the Use of Proton Radiation Therapy in NCI-Sponsored Cooperative Group Trials. Proton therapy techniques may include passively scattered or scanning or pencil beam technology."
15948687|NCT03274414|Procedure|Endoscopic Resection|In brief, an endoscope is used and two surgeons perform the intervention in a binostril manner. Tumor is generally resected with an emphasis on identification of the attachments in the paranasal sinuses, nasal cavity, or skull base.
15948718|NCT03274206|Drug|Placebo|BLS-ILB-E710c-placebo
15983842|NCT03008746|Other|water used for oral wash|
15948688|NCT03274414|Drug|cisplatin and etoposide|If the final surgical pathology report shows SNUC, at the discretion of the treating medical oncologist, the patient will receive an addition of etoposide chemotherapy to cisplatin chemotherapy. The dose of cisplatin will be decresed from 100 mg/m2 to 60 mg/m2. Cisplatin should be administered on days 1-2, 21-22 and 42-43 at a dose of 60 mg/m2 and Etoposide should be administered at days 1-3, 21-23, and 42-44 at a dose of 120 mg/m2.
15948689|NCT03274401|Device|Zenicor intermittent ECG device|At least two weeks of screening twice daily for atrial fibrillation using intermittent ECG recordings, and prolonged use of OAC-therapy if atrial fibrillation is detected
15948690|NCT03274388|Procedure|nutritional therapy|protein-rich nutritional therapy and counseling, during study period of 12 weeks
15948691|NCT03274388|Procedure|WB-EMS combined with nutritional therapy|protein-rich nutritional therapy and counseling plus whole body electromyostimulation exercise training, twice a week for 20 min., during study period of 12 weeks
15948692|NCT03274375|Drug|IA session|10 IA sessions performed in 28 days maximum, using TherasorbTM adsorbers which contain sheep derived polyvalent antihuman-immunoglobulin coupled to SepharoseTM CL-4B.
15948693|NCT03274375|Drug|Rituximab|"Concomitantly, Rituximab will be given each week for 4 weeks (one injection by week +/- 3 days):
~at least 1 day before each IA session
~the last injection will occur after the last session IA (minimum one day after)"
15948694|NCT03274362|Behavioral|Headspace Mindfulness App|Participants will be given instructions on how to download Headspace on an electronic device and will be provided a free 3-month access code. The app contains a series of ten step-wise 10-minute video sessions that guide the user through mindfulness training. Upon completion of these sessions, additional content will be accessible, including sessions on health (depression, self-esteem, anxiety, sleep, and pregnancy), relationships (kindness, generosity, relationships, change, appreciation, and acceptance) and performance (creativity, focus, happiness, and balance). The frequency and duration of usage will be in accordance to the instructions of the app.
15948695|NCT03274349|Procedure|whole body electromyostimulation exercise|whole body electromyostimulation exercise training twice a week for 20 min each, bipolar, 85 Hz, intermittent pulse/pause, pulse width 350 µsec
15948696|NCT03274349|Procedure|protein-rich nutrition therapy|protein-rich nutrition therapy with an objective of reaching 1,2 to 1,5 g protein/kg body weight and day
15948697|NCT03274336|Behavioral|questionnaire|questionnaire post preanesthetic interview
15948698|NCT03274336|Behavioral|face-to-face interview|Group A = face-to-face interview
15948699|NCT03274336|Behavioral|brochure|after reading a brochure a face to face interview will take place
15948700|NCT03274336|Behavioral|movie|after seeing a film about the procedure a face-to-face interview will take place
15948701|NCT03274323|Device|iStent and travoprost or latanoprost|2 iStents will be inserted and patients will be started on travoprost or latanoprost following the procedure
15948702|NCT03274323|Procedure|Trabeculectomy|Standard trabeculectomy
15948703|NCT03274310|Behavioral|Educational text messages|Educational text message about ways to decrease household transmission of influenza and other respiratory infections
15948704|NCT03274297|Drug|EVRA patch (NGMN+EE) (Treatment A) (Reference)|A single transdermal contraceptive patch of EVRA (NGMN + EE) containing 6 milligram (mg) of the progestin NGMN and 600 microgram (mcg) of the EE will be applied to the buttock (right or left) of participants on Day 1 of each treatment period and is removed 7 days after patch application, ie, on Day 8.
15948705|NCT03274297|Drug|HMW PIB patch (NGMN+EE) (Treatment B) (Test)|A single transdermal contraceptive HMW PIB (NGMN + EE) patch containing 6 mg of the progestin NGMN and 600 mcg of the EE will be applied to the buttock (right or left) of participants on Day 1 of each treatment period and is removed 7 days after patch application, ie, on Day 8.
15948706|NCT03274284|Combination Product|chemoradiation|chemoradiation in case of T1G3 BC after BCG failure.
15948707|NCT03274271|Behavioral|Action planning|Action planning is the behaviour change technique used to make users specify their goal (what they are going to do, when, where, ...).
15948708|NCT03274271|Behavioral|Coping planning|Coping planning is the behaviour change technique used to make users think about possible hindrances and according solutions when trying to reach their goal.
15948709|NCT03274271|Behavioral|Self-monitoring|Self-monitoring is the behaviour change technique used to make users keep track of their goal.
15948710|NCT03274271|Behavioral|Feedback and tips|In this intervention, users receive tailored feedback on their current health behaviour and tips and tricks to reach their goals. This tips and tricks include the behaviour change technique 'eliciting social support'.
15948711|NCT03274258|Biological|Ipilimumab|Given IV
15948712|NCT03274258|Biological|Nivolumab|Given IV
15948713|NCT03274245|Behavioral|Intervention Package|"Community Level:
~Palla: songs and skits to increase knowledge of and motivation for latrine use, pit emptying, safe feces disposal;
~Transect Walk: village walk to identify and mark feces in community;
~Community meetings: sex-segregated meetings with village members to decide on an action plan to increase community cleanliness/reduce open defecation;
~Wall painting: village map noting households that use latrines always.
~Sub-Community level:
~Mothers meeting: For caregivers with children under age 5, to provide knowledge of and hardware for safe child feces disposal.
~Household Level:
~Household visits: to those with latrines to motivate use;
~Latrine repairs: for households with non-functional latrines to make functional."
15948714|NCT03274245|Other|Qualitative Research|"For villages receiving the intervention package, investigators will engage community members through qualitative interviews to gain their perception of the intervention, what they thought of the intervention activities, what information they recall, what aspects they enjoyed or disliked, if they had barriers to attendance or participation.
~For the three villages not receiving the intervention, investigators will conduct qualitative interviews to determine additional barriers and determinants of latrine use to identify other potential intervention strategies."
15948715|NCT03274232|Device|SUNEKOS ® 200|micro-injections of the study product were performed by a specialized dermatologist, bilaterally on the face (zygomatic protuberance, nostril's angle, inferior margin of tragus, lip marionette lines, mandibular angle) of female volunteers aged 45-65 years, with photoaging of mild/moderate grade
15948716|NCT03274219|Biological|bb21217|autologous T cells transduced ex-vivo with anti-BCMA CAR lentiviral vector encoding the chimeric antigen receptor (CAR) targeted to human BCMA, suspended in cryopreservative solution
15948717|NCT03274206|Biological|BLS-ILB-E710c|BLS-ILB-E710c 250mg/capsule
15948719|NCT03274193|Behavioral|Yoga training program|The hatha yoga program will be led by an experienced yoga instructor. Each 60 minutes session will consist of 10 minutes of breathing exercises (pranayama), 40 minutes of yoga pose practice (asana), and 10 minutes of supine meditation/relaxation (savasana). Yoga props, such as blocks and belts, will be used in accordance to each participant's particular body type and needs to help he/she achieve precise yoga postures safely and comfortably. The yoga poses are chosen for providing a restorative session and based on their purported relationship to restorative effects. Participants will be instructed to maintain their concentration and breath control at all times during the yoga session.
15948720|NCT03274180|Other|Nursing consultation|travel preventive consultation was performed by nurse
15948721|NCT03274167|Drug|Gabapentin 300mg|
15948722|NCT03274167|Drug|Placebo oral capsule|
15948723|NCT03274154|Dietary Supplement|Pre-Hyaluron 465 Innēov|Food supplement consisting og a tablet and a capsule, composed with a precursor of HA (glucosamine) and an enzymatic co-factor of HA synthesis (manganese)
15948724|NCT03274141|Other|Non-Interventional|Non-Interventional
15948725|NCT03274128|Radiation|Radon therapeutic baths and inhalations|The natural water with low mineralized content plays a major therapeutic role with the parameters of Rn 303,1-441,5 Bq/l. In the treatment rooms (inhalation, cabins with baths and swimming pool) measurement of alpha radiation was 184,4-450,0 MeV. The measurements were analyzed every 3 months at the Institute of Occupational Medicine in the Department of Radiation Protection in Lodz, Poland. Among the types of treatments used in the therapy there was: comprehensive radon bath - with the temperature of 37 °C, duration 15 min., the treatments were performed every 2nd day, whereas radon inhalations lasted 15 min. with the temp. 37 °C- treatments were performed every 2nd day from Monday to Friday. Baths and inhalations were performed interchangeably and the total number of radon treatments during one stay was 15.
15948726|NCT03274128|Procedure|Kinesiotherapy|It is the therapeutic treatment of disease by passive and active muscular movements (as by massage) and of exercise. It is the core element of physiotherapy/physical therapy. Kinesiotherapy - duration of 30-45 min,
15948727|NCT03274115|Device|BLI (Blue Laser Imaging)|Switch from white light to BLI (Blue Laser Imaging) to predict the histology of colonic polyps
15948728|NCT03274102|Biological|Concomitant administration of EV71 vaccine with EPI vaccines|"The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.； the recombinant hepatitis B vaccine was manufactured by Shenzhen Kangtai Biological Products Co., Ltd; the Group A meningococcal polysaccharide vaccine was manufactured by Wuhan Institute of Biological Products Co., Ltd.
~The primary vaccination schedule of hepatitis B vaccine includes 3 doses with a schedule of 0,1,6 month, and subjects only receive 3rd vaccination in this study; the primary vaccination schedule of Group A meningococcal polysaccharide vaccine includes 2 doses with 3 months interval between doses, and subjects only receive 1st vaccination in this study"
15948729|NCT03274102|Biological|Single injection of EPI vaccine|"The recombinant hepatitis B vaccine was manufactured by Shenzhen Kangtai Biological Products Co., Ltd; the Group A meningococcal polysaccharide vaccine was manufactured by Wuhan Institute of Biological Products Co., Ltd.
~The primary vaccination schedule of hepatitis B vaccine includes 3 doses with a schedule of 0,1,6 month, and subjects only receive 3rd vaccination in this study; the primary vaccination schedule of Group A meningococcal polysaccharide vaccine includes 2 doses with 3 months interval between doses, and subjects only receive 1st vaccination in this study"
15948730|NCT03274102|Biological|EV71 Vaccine only|The investigated EV17 vaccine was manufactured by Sinovac Biotech Co., Ltd.
15948731|NCT03274089|Device|Kiosk intervention group|"SEEK automates the management of patients with stable well-controlled chronic disease. SEEK has the following capabilities:
~Collects patient information using patient-specific identification
~Prompts the user for answers to screening questions for acute conditions
~Measures relevant physiological parameters: blood pressure, height, weight; and calculates body mass index
~Triages patients based on responses to screening questions, physiological parameters and blood test results
~Provides recommendations to the patient on the care plan, self management and lifestyle choices"
15948732|NCT03274076|Drug|Tofacitinib|Oral medication tofacitinib 5 mg twice a day for 24 weeks.
15948733|NCT03274076|Drug|Placebo Oral Tablet|Oral Placebo 5 mg twice a day for 24 weeks
15948734|NCT03274063|Other|Supported self-management|Participants will be supplied with urate self-testing kits. Participants will have a mobile phone application installed which will prompt the participant to perform urate self-testing, enable the clinical research team to advise on escalation of urate lowering therapy, and collect quality of life data .
15948735|NCT03274063|Other|Usual care|Participants will have a mobile phone application installed which will allow the research team to collect quality of life data.
15948736|NCT03274037|Diagnostic Test|Device for mechanical excitation by pressure waves|"The IRM elastography technique, proven and patented in 2010 by the IR4M (Orsay, France), consists in characterizing by IRM induced waves in the human body in order to determine the mechanical properties Of the target organ.
~The mechanical waves will be induced by pressure waves guided at the mouth of the subject elongated in the MRI and consisting of a function generator at a frequency between 5 Hz and 500 Hz, linear amplifier , An electromechanical transducer, a waveguide whose length is adapted to the chosen excitation frequency, an antibacterial filter and a disposable mouthpiece
~The MRI imager Achieva 1.5 T MRI (Philips Healthcare, Best, the Netherlands) and the SIGNA Architect GEM 3.0T (GE medical systems, LLC, USA) system will be used to measure brain tissue displacement fields."
15948737|NCT03274024|Device|Ahmed Glaucoma Implant|Conjunctival Flap Scleral Exposure Insertion of Episcleral Plate Priming of the tube prior to AC entrance Insertion of Tube into the Anterior Chamber Suturing tube Coverage of tube
15948738|NCT03274024|Procedure|Trabeculectomy with Mitomycin C|Conjunctival Flap Mitomycin C Application Scleral Flap Paracentesis Excision of Limbal Tissue Peripheral Iridectomy Scleral Flap Closure Conjunctival Flap Closure
15948739|NCT03274011|Drug|Apatinib|Apatinib is a small-molecule tyrosine kinase inhibitor (TKI) that highly selectively binds to and strongly inhibits vascular en-dothelial growth factor receptor 2 (VEGFR-2), with a decrease in VEGF-mediated endothelial cell migration, proliferation, and tumor microvascular density. Previous data showed that apatinib treatment significantly improved OS and PFS with an acceptable safety profile in patients with advanced gastric cancer refractory to two or more lines of prior chemotherapy. Our study will observe the efficacy and safety of Apatinib for recurrent or metastatic esophageal squamous cell carcinoma: A phase II, prospective, single-arm, multicenter trial.
15948740|NCT03273985|Other|Dry needling|Trigger point deep dry needling
15948741|NCT03273985|Other|Ischemic compression|Trigger point ischemic compression
15948742|NCT03273972|Other|Written Informed Consent|To be completed prior to conducting any study related procedures
15948743|NCT03273972|Other|Inclusion/Exclusion check|Eligibility check
15948744|NCT03273972|Other|Full Clinical Chemistry and Haematology Bloods|Participant required to fast for at least 6-8 hoursprior to visit. (Clear, non-caffeinated fluids are allowed)
15948745|NCT03273972|Other|Serum sample for systemic markers and lipid sub-fractions|Serum samples may be stored for later analysis.
15948746|NCT03273972|Other|Pregnancy Test|If applicable for women of child bearing potential
15948747|NCT03273972|Other|12 Lead ECG|participant resting supine
15948748|NCT03273972|Other|Blood Pressure and Heart Rate|Measured in the seated position after 5 minutes rest
15948749|NCT03273972|Other|Arterial Stiffness|Measure of functional and structural changes which accompanies cardiovascular disease
15948750|NCT03273972|Other|Central Haemodynamics|Measure of functional and structural changes which accompanies cardiovascular disease
15948751|NCT03273972|Other|Carotid Intima Media Thickness|Measurements will be repeated three times, and the average of the median values will be recorded
15948752|NCT03273972|Other|Forearm blood flow studies|Assess and determine vascular function, which can interrogate endothelium dependent and independent mechanisms of nitric oxide bioavailability
15948753|NCT03273972|Other|Concomitant medication check|Review of medication taken by the participant
15948754|NCT03273972|Other|Medication compliance check (Pill count)|Ensure prescribed statin has been taken
15948755|NCT03273972|Other|Physical examination|Check overall health
15948756|NCT03273972|Other|Medical history|Review of volunteers medial history
15948757|NCT03273972|Other|AE/SAE review & reporting|Monitor safety from the point of consent
15948758|NCT03273972|Drug|Dosing|To be performed at the end of the visit following completion all other study visits
15948759|NCT03273959|Other|Exercise protocol|Protocol of exercises performed in hospital admission in children and adolescents with cystic fibrosis in the exacerbation phase.
15948760|NCT03273946|Drug|Fluticasone propionate|Fluticasone propionate is an inhaled corticosteroid to be used via a pediatric spacer device with a face mask for prophylactic treatment of asthma.
15948761|NCT03273933|Device|DragONE|The DragONE application for iOS and Android, developed in collaboration with the Institute for Educational Technologies of the National Research Council of Palermo, allow children to daily fill electronically the C-ACT questionnaire and the symptom diary card.
15948762|NCT03273933|Device|SmartOne|A little portable spirometer connected to DragONE allows daily PEF monitoring.
15948763|NCT03273920|Procedure|Robotic distal gastrectomy with D2 nodal dissection|After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, robotic distal gastrectomy with D2 lymph node dissection will be performed with curative treated intent.The type of reconstruction will be determined by the surgeon's experience and preference. The reconstruction can be carried out by extracorporeal or intracorporeal anastomosis.
15948764|NCT03273920|Procedure|Laparoscopic distal gastrectomy with D2 nodal dissection|After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, laparoscopic distal gastrectomy with D2 lymph node dissection will be performed with curative treated intent.The type of reconstruction will be determined by the surgeon's experience and preference. The reconstruction can be carried out by extracorporeal or intracorporeal anastomosis.
15948765|NCT03273907|Device|CyPass Micro-Stent implanted with CyPass 241-S applier|CyPass System (Model 241-S) consists of the CyPass Micro-Stent contained in a loading device (loader) and the CyPass applier.The CyPass Micro-Stent is an implantable medical device intended for long term use.
15948766|NCT03273894|Diagnostic Test|Coagulation testing|"body temperature before the intervention
~body temperature during the intervention including the way of measuring, each 15 minutes
~body temperature at the end of surgery, signs of the patient's heat discomfort
~body temperature during resting time in the postanesthesia care
~standard coagulation tests + EXTEM, FIBTEM, NATEM - after anesthesia induction
~blood sampling for standard coagulation tests (prior to the end of the surgical intervention) + EXTEM, FIBTEM, NATEM.
~if body temperature is below 34°C, two sets of ROTEM tests are run: one at patient's body temperature, following by another one at a standard temperature (37°C)."
15948767|NCT03273881|Drug|glucose solution and Insulin|"Women in group 1, will receive intravenous saline solution boosted with 5% glucose combined with 8 units of insulin at a rate of 125mL/h. The desirable intrapartum glucose level will be 70 to 100 mg/dL. Glucose levels will be checked hourly.
~Glucose level between 100-140 mg/dL will be treated with additional intravenous insulin, 1 units/hour.
~Glucose level between 141-160 mg/dL will be treated with intravenous insulin, 2 units/hour. Additionally, the 5% glucose solution will be substitute with lactated Ringer's solution.
~Glucose level between 161-200 mg/dL will be treated with intravenous insulin, 4 units/hour.
~Glucose level above 200 mg/dL will be treated with intravenous insulin, 6 units/hour."
15948768|NCT03273881|Drug|glucose solution only|Women in group 2, will receive intravenous saline solution boosted with 5% glucose only, at a rate of 125mL/h. Women in this group will be treated similar to group 1 if glucose levels crossed over 100 mg/dL.
15948769|NCT03273868|Other|High velocity low amplitude manipulation|The researcher manually applies a preload force on the T5/T6 level followed by a single posterior to anterior thrust.
15948770|NCT03273868|Other|Sham manipulation|The researcher manually applies a preload force on the right scapula followed by a single lateral thrust.
15948775|NCT03273816|Behavioral|sessions of sophrology|10 sessions of sophrology in preparation for the intervention 5 weeks before this one.
15948776|NCT03273803|Diagnostic Test|Heart sound recording using smartphone application|Heart sound recording and analysis using android smartphones (Samsung Galaxy S5, Galaxy S6, and LG G3)
15948777|NCT03273790|Other|Non-interventional|Non-interventional
15948778|NCT03273777|Procedure|Drawing of an incision line|Drawing of an incision line prior to skin incision at cesarean section
15948781|NCT03273738|Diagnostic Test|folate level measurement|the level of folate measured in plasma with homocysteine
15948782|NCT03273738|Diagnostic Test|B12|B12 measurement in blood
15948783|NCT03273725|Other|Dental examination including taking a saliva sample.|The main focus of the dental examination is enamel defects and caries. Saliva samples (stimulated) will also be taken.
15948784|NCT03273712|Radiation|90Y-DOTA tyr3-Octreotide|90Y-DOTATOC is a radiopharmaceutical that will be used as a treatment for both children and adults with neuroendrocrine and other somatostatin receptor positive tumors.
15948785|NCT03273712|Diagnostic Test|68Ga-DOTATOC PET Positron Emission Tomography (PET) whole body scan|68Ga-DOTATOC is a radiopharmaceutical used in PET scans to identify tumors as it can adhere to Somatostatin Receptors.
15948786|NCT03273712|Drug|Amino Acids|This is a solution of amino acids that will decrease the amount of 90Y-DOTATOC that recirculates through the body after injection, therefore decreasing the radiation dose to the kidneys.
15948787|NCT03273699|Device|Mindfulness|Clients will use a consumer grade EEG device that provides guided mindfulness home practices
15948788|NCT03273686|Procedure|Discharge the NG tube during the surgery|Discharge the NG tube during the surgery.
15948789|NCT03273673|Other|Biofeedback Intervention|Visual and Tactile Biofeedback
15948790|NCT03273660|Device|Aliaxin (new trademark - IBSA Farmaceutici Italia S.r.l.)|"First treatment was performed during baseline visit, after the basal evaluations planned by the study procedure.
~0.5-1.1 ml of Aliaxin (new trademark) for emi-face was injected by needle (25-27 G) and/or cannula (25 G, 40 mm).
~A touch-up treatment (0.5-1.1 ml of Aliaxin new trademark for subject) was performed after 3-4 weeks (T1) in order to treat possible asymmetry."
15948791|NCT03273647|Radiation|radiation|"A total dose of 40Gy will be delivered in 20 fractions at 2.0Gy/fraction, 5 fractions per week in 4 weeks.
~The CTV encompassed the bilateral supraclavicular region, all mediastinal lymph nodes, the anastomosis site, and the left gastric and Celiac nodes."
15948792|NCT03273634|Drug|Lansoprazole Pill|once daily at night time
15948793|NCT03273634|Drug|Placebo|Placebo
15948794|NCT03273621|Procedure|Bariatic surgery|One of two different types of surgery: sleeve gastrectomy and Roux-en-Y gastric by-pass.
15948795|NCT03273595|Drug|Lapatinib|
15948796|NCT03273595|Biological|Trastuzumab|
15948797|NCT03273595|Drug|Paclitaxel|
15948798|NCT03273595|Drug|Epirubicin|
15948799|NCT03273595|Drug|Cyclophosphamide|
15948800|NCT03273569|Procedure|PDI-UC protocol|Preplacental delivery intervention for uterine conservation protocol starts after delivery of the fetus during Cesarean delivery and consists of delayed cord clamping, intramyometrial injection of vasopressin, subdecidual injection of saline, ligation of the uterine arteries, multiple 8 compression sutures, followed by delivery of the placenta, application of pressure and interrupted sutures if needed
15948801|NCT03273556|Device|Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.) with Lidocaine 0.3%|"The injective treatment was performed, during T0 visit after the basal evaluations, mono-laterally on nasolabial fold,(right or left face side in according to a previously defined randomisation list).
~A quantity of Aliaxin® Ev (up to a maximum of 0.5 ml) with Lidocaine 0.3% was injected on the nasolabial fold to achieve the aesthetic correction of the skin defect."
15948802|NCT03273556|Device|Aliaxin® EV Essential Volume (IBSA Farmaceutici Italia S.r.l.)|"The injective treatment was performed on the contralateral nasolabial fold during T0 visit, after the basal evaluations .
~A quantity of Aliaxin® Ev up to a maximum of 0.5 ml was injected on the nasolabial fold to achieve the aesthetic correction of the skin defect."
15948803|NCT03273543|Device|Restylane® Defyne|hyaluronic acid filler injection
15948804|NCT03273530|Other|Integrated Supported Employment|vocational assessment followed by job placement and on-going work-related social skills revision and reinforcement
15948805|NCT03273517|Procedure|Elective surgery|Elective surgery in children aged 0-15 years ASA I and II
15948806|NCT03273504|Other|Actapil Corpo Spray (SHEDIR PHARMA Srl - Italy)|The study product will be applied twice a day (at morning and at evening) for an interrupted period of 3 months, on the right or left leg (tibialis area) according to a randomisation list.
15948807|NCT03273504|Other|Placebo|The placebo product will be applied twice a day (at morning and at evening) for an interrupted period of 3 months, on the controlateral leg (tibialis area) right or left leg according to a randomisation list.
15948808|NCT03273491|Behavioral|daily self-weighing|Participants are provided with a wifi-enabled scale and asked to weigh themselves daily, first thing in the morning.
15948809|NCT03273491|Behavioral|daily temperature-taking|Participants are provided with a wifi-enabled thermometer and asked to take their temperature daily, first thing in the morning.
15948810|NCT03273478|Device|Endovascular treatment of bifurcation aneurysm with pCONUS2|"Patients suffering from a bifurcation aneurysm will be treated endovascularly with the pCONUS2 device.
~The patients do not face any additional risks by participating in the study as the treatment does not differ from the standard of care in any way.
~The patients will only be enrolled in the study if they give their written consent.
~If they do not wish to participate in the observational study or if they wish to withdraw from it at a later date, they will not have any disadvantages."
15948811|NCT03273465|Other|Fecal transplantation|Fecal transplantation administered orally via frozen capsules.
15948812|NCT03273452|Drug|Chidamide|Chidamide will be given orally 30mg,biw, along with PET regimen (prednisone 100mg,po,qd,d1-5; etoposide 100mg,po,qd,d1-5; thalidomide 100mg,po,qn,d1-14;)
15983843|NCT03008746|Other|sputum|
15948813|NCT03273439|Device|repetitive TMS|Prior to each TMS administration, motor threshold was determined by stimulating the left motor strip with the lowest possible energy to produce, within 10 stimuli, at least 5 evoked potentials Z0.05 . In active rTMS, 10 Hz stimulations over left DLPFC occurred at a power of 110% of motor threshold (MT) for 5-s intervals with 30-s intertrain interval. 30 trains were administered each day (MondayFriday) for 4 consecutive weeks (total stimuli=30,000).
15948814|NCT03273439|Device|Sham rTMS|Sham rTMS, without stimulation
15948815|NCT03273426|Procedure|Minimally-invasive biopsy|Intervention (core needle biopsy (14G) or vacuum-assisted biopsy(10G)) for complete clinical response (cCR) or near-cCR predicted by MRI.
15948816|NCT03273426|Procedure|wide excision|Surgical wide excision of the biopsied area.
15948817|NCT03273413|Drug|Pravastatin|Anti-inflammatory, anti-oxidative stress, and anti-proliferative therapy
15948818|NCT03273413|Drug|Placebo|Inactive tablet
15948819|NCT03273400|Other|Lumbar Mobilisations|Please see arm (intervention) description
15948820|NCT03273387|Drug|Trimetazidine|The participant will received trimetazidine 35 mg bid for 3 months on top of their regular PAH specific therapy.
15948821|NCT03273387|Drug|Placebo oral capsule|The participant will received placebo oral capsule bid for 3 months on top of their regular PAH specific therapy.
15948822|NCT03273374|Device|Intraoperative radiation therapy (IORT)|IORT with 50 kV x-ray will be delivered during surgery as a single dose of 10 Gy at 5 millimeter depths of the tumor bed, followed by gemcitabine chemotherapy (1000 mg/m2) every 4 weeks for a total of 6 cycles
15948823|NCT03273361|Behavioral|Compact Cycling Device|Participants pedaled a compact cycling device while simultaneously working at a desk.
15948824|NCT03273348|Procedure|Oncoplastic breast surgery|, Skin sparing mastectomy and immediate breast reconstruction will be conducted to all women included in the study, transverse rectus abdominis musculocutaneous flap recostruction and latissimus dorsi myocutaneous pedicle-flap with and without implant
15948825|NCT03273335|Device|Millipore biomarker assay plate|Millipore biomarker assay plate CSF cytokine assays as well as CSF flow cytometry
15948826|NCT03273322|Drug|Rivaroxaban 10 mg qd|10mg qd
15948827|NCT03273322|Drug|Rivaroxaban 15 mg qd|15mg qd
15948828|NCT03273322|Drug|DAPT|Aspirin 75 mg qd + Clopidogrel 75 mg qd
15948829|NCT03273309|Other|Vibratory Perineal Stimulus|Vibratory perineal stimulus will be applied in patients randomized to this group through an intravaginal probe which emits vibratory pulses, with the device fixed in the following parameters:on time = 8 seconds, off time = 16 seconds, total time = 20 minutes. The intervention time will be 6 weeks, with sessions held once a week.
15948830|NCT03273309|Other|Transvaginal Electrical Stimulation|The transvaginal electrical stimulation will be applied in patients randomized to this group through an intravaginal probe which emits electrical pulses, with the device fixed in the following parameters: frequency = 50 Hz, pulse width = 300ms,on time = 8 seconds, off time = 16 seconds, total time = 20 minutes. The intervention time will be 6 weeks, with sessions held once a week.
15948831|NCT03273296|Drug|Amoxicillin|Amoxicillin (po) 500 mg x 3 per day for 3 days.
15948832|NCT03273296|Drug|Azithromycin|Azithromycin (po) 500 mg x 1 on day 1, 250 mg x 1 on day 2, and 250 mg x 1 on day 3.
15948833|NCT03273296|Drug|Vancomycin|Vancomycin (po) 125 mg x 4 per day for 3 days.
15948834|NCT03273283|Behavioral|Brief Intervention|Patient's received a brief intervention on alcohol use based on motivational techniques, and a referral to treatment when indicated.
15948835|NCT03273270|Radiation|transcranial magnetic stimulation|transcranial magnetic stimulation
15948836|NCT03273257|Drug|Riociguat|"Riociguat will be initiated at 1 mg tid. The dosage will be increased by 0.5 mg at 2 week intervals based on tolerability as assessed by systolic blood pressure up to a maximum dose of 2.5 mg tid.
~Downtitration to 0.5 mg tid is foreseen for patients with low optimal tolerability."
15948837|NCT03273257|Drug|Placebo|Placebo will be given analogue to riociguat with matching tablets.
15948838|NCT03273257|Procedure|Pulmonary endarterectomy|PEA will be performed at the end of medical treatment (Day 90)
15948839|NCT03273244|Device|NeuroSense monitoring and ANI monitoring|From the start of palliative sedation, monitoring of EEG with NeuroSense device (WAVcns: Wavelet Anesthetic Value of the Central Nervous System) and ANI-monitoring (Analgesia Nociception Index) will be initiated.
15948840|NCT03273231|Drug|Ketamine|Ketamine is administered intravenously with a loading dose of 0.25 mg/kg at 5 minutes before surgery, followed by an infusion rate of 0.05 mg/kg/h to the end of surgery.
15948841|NCT03273231|Drug|Saline|0.9% saline solution
15948842|NCT03273218|Device|Tiger catheter|
15948843|NCT03273218|Device|Judkins catheter|
15948844|NCT03273205|Device|Anodal tDCS|This group gets a real stimulation
15948845|NCT03273205|Device|Sham tDCS|This group gets a sham stimulation
15948846|NCT03273192|Drug|Adalimumab|A single 40-mg dose of Adalimumab is administered subcutaneously to all the subjects.
15948847|NCT03273166|Device|INVSENSOR00001|This is a non-randomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers.
15948848|NCT03273166|Device|Control SpHb sensor|This is a non-randomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers.
15948849|NCT03273166|Procedure|Hemodilution|This is a non-randomized single arm study wherein all subjects are enrolled into the experimental arm and receive both the INVSENSOR00001 sensor and the control sensor simultaneously on different fingers while undergoing a hemodilution procedure.
15948850|NCT03273153|Drug|Cobimetinib|Cobimetinib 60 mg tablets orally once daily on a 21 days on, 7 days off schedule.
15948851|NCT03273153|Drug|Atezolizumab|Atezolizumab 840 mg as IV infusion once in every 2 weeks.
15948852|NCT03273153|Drug|Pembrolizumab|Pembrolizumab 200 mg as IV infusion once in every 3 weeks.
15948903|NCT03272737|Device|Basal blood flow and vasodilatory capacity - Flow mediated dilation (FMD)|Images of the brachial artery will be recorded by a two-dimensional ultrasonography device with a spectral Doppler and linear transducer (Ultra-0122, Philips, The Netherlands).
15948904|NCT03272737|Diagnostic Test|Quality of Life EuroQol-5 Domain|This questionnaire is used to estimate the quality of life in participants before and after the study.
15948853|NCT03273140|Device|Gamification Diabetes Education Program (GDEP)|"Diabetic application focuses on diabetes management and consists of two gamelets and consist of story-telling, case scenarios with the integration of problem-based decision-making and solving skills in diabetes management. These scenarios created are familiar to the patients and nurses - to make the games more interactive and realistic to the players (participants). Immediate feedback will be given after they select their decision. The visual reward will appear after attaining one score for each correct question. Participants can easily access and play the games several times till contents are reinforced and knowledge is retained or at their own comfort level. This game mechanics aim to motivate and assist patients to achieve their desired result and self-efficacy behaviors. It addresses the deficits from the current literature review, by aiming to be up-to-date, reliable with new updated scenarios and platform."
15948854|NCT03273127|Drug|Abediterol|A β2-adrenoceptor agonists, produce smooth muscle relaxation in the airways and improves lung function.
15948855|NCT03273127|Drug|Placebo|Abediterol matching placebo without any pharmacological activity.
15948856|NCT03273114|Behavioral|Cognitive Functional Therapy|"There will be four main components in the intervention, following the protocol used by O'Keefe et al. (2015):
~The cognitive component will focus on on the multidimensional nature of persistent pain about individual beliefs, and how emotions and behaviors (movement and lifestyle) can reinforce a vicious cycle of pain and disability.
~Specific Functional training is designed to normalize maladaptive or provocative movement and posture.
~Functional integration directed to activities of daily life that are avoided by the patient (rolling in bed, sitting, sitting to standing, walking, bending and lifting)
~Patients will be advised to gradually increase physical activity based on their preference, also focusing on sleep hygiene, stress, and management strategies"
15948857|NCT03273114|Other|Core Training Exercise and Manual Therapy|According to the pragmatic clinical decision of the physiotherapist responsible for this intervention arm, participants allocated to the comparison group will be treated with active exercises will involve contractions of abdominal and back muscles in different functional positions, as well as joint mobilization or manipulation techniques applied to the lower back or pélvis, when necessary. Most patients in this group will receive exercises to perform at home, but not related to CFT.
15948858|NCT03273101|Device|Mechanical assisted sit-to-stand training group|Mechanical assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions
15948859|NCT03273101|Other|Manual assisted sit-to-stand training group|Manual assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions
15948860|NCT03273088|Drug|Etanercept|A single dose of etanercept (25mg/0.5ml prefilled syringe) was administered subcutaneously to healthy subjects.
15948861|NCT03273075|Drug|Cangrelor|The intervention comprises add-on Cangrelor infusion (administration in compliance with manufacturer instructions) in addition to and after administration of standard P2Y12-blocker (prasugrel or ticagrelor) therapy.
15948862|NCT03273075|Drug|Placebo|The intervention comprises add-on placebo infusion (0.9% NaCl) in addition to and after administration of standard P2Y12-blocker (prasugrel or ticagrelor) therapy as placebo comparator
15948863|NCT03273075|Drug|Prasugrel|The intervention comprises the standard P2Y12-blocker prasugrel therapy if not contraindicated.
15948864|NCT03273075|Drug|Ticagrelor|The intervention comprises the standard P2Y12-blocker ticagrelor therapy if prasugrel is contraindicated and no contraindication to ticagrelor is present.
15948865|NCT03273062|Drug|Tolcapone 200 MG|Tolcapone 200 MG TID
15948866|NCT03273062|Other|Placebo|Placebo, TID Placebo will be in capsules that are identical in appearance to intervention drug, Tolcapone.
15948867|NCT03273036|Drug|40 mg Triamcinolone acetate 1 cc|40 mg Triamcinolone acetate 1 cc
15948868|NCT03273036|Drug|Placebos|no injected agent
15948870|NCT03273010|Procedure|Free gingival graft|Free gingival graft was harvested from palatal donor site
15948871|NCT03273010|Procedure|Cyanoacrylate application|Periacyrl was applied on palatal wounds
15948872|NCT03272984|Procedure|ERAS group|ERAS is the name of a procedure. Patients in this group need receive the ERAS procedure instead of one drug.
15948873|NCT03272984|Procedure|SC group|Patients were managed in accordance with SC programs during the perioperative period. SC programs were used daily in our center and were still routinely used in most of the other hospitals in China.
15948874|NCT03272971|Device|Radio-frequency Ablation|The intervention consists of a bronchoscopic approach to ablate lung tumors with radiofrequency.
15948875|NCT03272945|Procedure|Linked-color imaging|Linked-color imaging colonoscopy
15948876|NCT03272932|Other|No intervention|No intervention
15948877|NCT03272919|Other|Arm 1: Investigational INF|INF utilizes three holds or positions, which widens tiny openings in arteries surrounding nerves and improves blood flow to targeted nerves. The improved blood flow in these nerves stimulates healing and reduces or even stops nerve pain.
15948878|NCT03272919|Other|Arm 2: standardized muscle stretching and strength|subjects will receive a standardized program of muscle stretching and strengthening exercise under the supervision of treating physical therapist.
15948879|NCT03272906|Device|Anodal transcranial direct current stimulation|2 mA of A-tDCS stimulation is induced between two 5 cm x 7 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 2 mA occurs over 30 seconds to allow participants to habituate to the tingling sensation. A-tDCS stimulation will be active only in the first 20 minutes of the 60-minute treatment session.
15948880|NCT03272906|Device|Sham transcranial direct current stimulation|2 mA of A-tDCS stimulation is induced between two 5 cm x 7 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 2 mA occurs over 30 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition.
15948881|NCT03272906|Behavioral|Speech-language therapy|Therapy tasks will be determined by the clinician on an individualized basis and will not be affected by this research protocol. The only difference between the clinical therapy that is normally provided in the clinic and this research paradigm is the application of tDCS electrodes during therapy. Therapist is blinded to stimulation type.
15948967|NCT03272425|Drug|allopurinol 300 mg|Comparator 2
15948882|NCT03272893|Behavioral|Acceptance and Commitment Therapy|The main component in the treatment is exposure to symptoms and feared situations. The iACT program is adapted from the evidence based face-to-face treatment at the Behavioral Medicine unit at Karolinska University Hospital. The iACT program has a different structure but is equal in content to face-to-face treatment, and is to be completed within ten weeks. Participants receive texts, audio files, movies and exercises and have online contact with their psychologist via an internet platform or a smart phone application. The treatment aims to encourage valued behaviors in the presence of inner discomfort.
15948883|NCT03272880|Behavioral|Arts-Based Programming|This feasibility study includes educational components and an experiential components which are assessed with pre- and post-tests. The topics of these components include: Introduction to the Arts and Health; Music, Well-Being, and Resilience; Movement and Physical Activity; Art and Well-Being; Theater and Socialization; Art Appreciation and a Healthy Brain; and Summary/Integration of the Arts into Daily Lives. The impact of this program will be assessed with qualitative follow-up interviews.
15948884|NCT03272867|Dietary Supplement|ProManna|
15948885|NCT03272854|Other|No intervention performed, the study is observational|
15948886|NCT03272828|Device|Nobel Biocare titanium dental implants|See above
15948887|NCT03272815|Device|Percussion Device (PD)|A laboratory prototype of the Percussion Device (PD) has been designed and built; laboratory data collection software, signal analysis and classification algorithms have been developed. It has been designed to detect a pneumothorax.
15948888|NCT03272815|Device|Ultrasound (US)|The SonoSite hand help portable ultrasound device.
15948889|NCT03272802|Drug|Edaravone|Edaravone is a free radical scavenger. this drug showed desirable effects like slowing decline of physical function by 33 percent in previous studies.
15948890|NCT03272802|Drug|Riluzole|Riluzole is a treatment option for amyotrophic lateral sclerosis. The occurrence of ventilator-dependence or tracheostomy is delayed in selected patients who treated with this drug.
15948891|NCT03272789|Other|Interviews with coach|For Interviews : done at Day 0 and at 1, 2, 3, 6 and 12 months. Questionnaires : given at Day 0, and at 3, 6 and 12 months.
15948892|NCT03272776|Device|Protector Laryngeal Mask airway|Evaluate the time of insertion, performance, security and insertion success rate of the Protector Laryngeal Mask in patients under general anasthesia.
15948893|NCT03272763|Device|F&P Toffee mask|Trial Full-Face mask which comes with three seal sizes and two headgear sizes.
15948894|NCT03272750|Dietary Supplement|Bioscalin® new formulation with Galeopsis Segetum|Total duration of the study was 4 months; each subject, took by mouth two capsules/die of placebo at breakfast and one tablet/die of study product at lunch for the first 3 months of the trial.
15948895|NCT03272750|Dietary Supplement|Reference product|Total duration of the study was 4 months; each subject, took by mouth two capsules/die of reference product at breakfast and one tablet/die of placebo at lunch for the first 3 months of the trial.
15948896|NCT03272750|Dietary Supplement|Placebo|Total duration of the study was 4 months; each subject, took by mouth two capsules/die of placebo at breakfast and one tablet/die of placebo at lunch for the first 3 months of the trial.
15948897|NCT03272737|Procedure|1RM Test|The dynamic force of the lower limb muscles will be evaluated by the maximal repetition of knee extension and leg press exercise, according to the protocol presented in a previous study [37]. The elderly will perform a warm up consisting of 1 series with 10 unloaded repetitions. After the warm up, the mass to be lifted will be progressively increased until the maximum load that can be lifted is reached, with a maximum limit of 5 attempts and a 3 to 5 minutes interval between them. The test will be conducted by a physical education professional who will verbally encourage participants throughout these steps and perform the load adjustment at week 5 and 10 (Radaelli, 2014).
15948898|NCT03272737|Procedure|Speed gait test|To measure the gait speed of participants they will walk 4.6 metres and the time needed to cover this distance is measured. The mean of three attempts is recorded and divided by the distance. The participants included must achieve in the walking test an average of < 0.,9 m/s (Guralnik, 1994).
15948899|NCT03272737|Device|Venous occlusion plethysmography protocol|A mercury-filled silastic tube, connected to a low-pressure transducer and a plethysmograph (D.E. Hokanson), will be placed around the largest circumference of the calf region. One cuff will be placed around the ankle and another around the thigh. The ankle cuff will be inflated to a supra-systolic pressure 30 seconds before starting the measurements. At 15-second intervals, the cuff around the thigh will be inflated above the venous pressure for a period of seven to eight seconds. Increased tension in the silastic tube reflects an increase in leg volume and vasodilation. The signal of the muscle blood flow wave will be recorded on a polygraph and analysed every minute, averaging three records per minute. The protocol will be performed during 5 minutes of rest, 3 minutes isometric exercise and 2 minutes of recovery (Bahia, 2006).
15948900|NCT03272737|Device|Measurement of Arterial Stiffness - Pulse Wave Analysis and Velocity|"Arterial stiffness will be estimated from the carotid-femoral aortic pulse wave velocity [33]. Carotid-femoral aortic pulse waves will be recorded by tonometry (SphygmoCor, AtCor Medical, Australia). At the same time, an electrocardiogram will be obtained to calculate the wave transit time. Two distances will be measured: the recording point of the carotid artery and the sternal furcula (distance 1) and the sternal furcula and the recording point in the femoral artery (distance 2). The distance travelled by the pulse wave will be calculated as distance 2 - distance 1. The carotid-femoral aortic pulse wave velocity will be calculated as: carotid-femoral aortic pulse wave velocity = ¼ * distance travelled by the pulse wave (m) / transit time(s)."
15948901|NCT03272737|Device|Isometric handgrip exercise protocol|In a supine position, the maximal voluntary handgrip force will be determined as the highest force in 3 consecutive attempts using a Jamar hydraulic palmar dynamometer (Asimow Engineering, CAL, USA). For activation of the central command, mechanoreceptors and muscular metaboreceptors the individual will perform, after 5 minutes of rest (baseline records), 3 minutes of exercise at 30% MVC. This manoeuvre isolates the activation of muscle metaboreceptors, observing the selective activation of these. After the isometric handgrip exercise, 2 minutes of recovery will be performed. Throughout the protocol muscle blood flow, blood pressure and heart rate will be recorded.
15948902|NCT03272737|Device|Vasodilatory capacity|The vasodilatory capacity will be calculated as the percentage of increase of the diameter of the brachial artery and femoral post occlusion in relation to its basal values.
15949025|NCT03272087|Device|Thoracoscopy|50 % of patients will have performed af medical thoracoscopy (pleuroscopy)
15983844|NCT03008746|Other|oral wash|
15948905|NCT03272737|Other|Anthropometric Assessment|Anthropometric measurements will be made before and after the training program following the standardization of the International Society for Anthropometric Assessments. The body mass will be measured with an accuracy of 0.1 kg (Filizola). The stature will be obtained by means of the stadiometer with an accuracy of 0.5 cm. The BMI will be calculated as body mass divided by height squared. The circumference of the quadriceps will be measured with a tape measure (Seca) with a precision of 0.1 cm.
15948906|NCT03272711|Drug|Vortioxetine 10 mg|
15948907|NCT03272711|Behavioral|Cognitive training program|Online training program, 30 minutes a day, 5 times a week
15948908|NCT03272698|Drug|Ketamine|IV Ketamine 0.50 mg/kg
15948909|NCT03272698|Procedure|ECT|ECT with unilateral or bilateral electrode placement and monitoring of seizure threshold by the half-age method
15948910|NCT03272685|Drug|Very Low Nicotine Content Cigarettes|0.4 mg/g nicotine; 9 mg tar
15948911|NCT03272685|Drug|Normal Nicotine Content Cigarettes|15.8 mg/g nicotine; 9 mg tar
15948912|NCT03272672|Other|Össür Unloading Knee Brace|"During the braced walking condition, a valgus unloader brace (Össür Unloader One®, Össur Americas, Orange County, CA) will be fitted by a certified athletic trainer per manufacturer instructions to the dominant limb while the participant is seated with knee flexed to approximately 80°.
~The brace will be maximally adjusted to unload the medial compartment."
15948913|NCT03272659|Drug|Cysview|250 mL enema containing 1.6 mmol of hexaminolevulinate
15948914|NCT03272646|Procedure|surgery|gastric resection or total gastrectomy
15948915|NCT03272633|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Receive IHC
15948916|NCT03272633|Biological|Irradiated Allogeneic Cells|Correlative studies
15948917|NCT03272607|Other|Deprescribing opportunities|An electronic intervention that identifies potentially inappropriate medications (PIMs) and generates instructions for safe discontinuation, which is presented to the treating physician for their consideration.
15948918|NCT03272594|Other|Breastfeeding|Infants will be placed in skin-to-skin contact with their mother at least five minutes prior to heel lance to allow time to settle and initiate breastfeeding. Breastfeeding position will be determined based on individual maternal preference in order to optimize feeding as well as to facilitate ease of access to the infant's foot for blood collection, while also attempting to minimize disruption of continuous EEG, heart rate, oxygen saturation, and video recording. Active breastfeeding will be facilitated to ensure it takes place for a minimum of two minutes prior to heel lance, and will continue until the procedure is completed.
15948919|NCT03272594|Drug|24% oral sucrose|Administration of 24 percent oral sucrose will occur two minutes prior to the heel lance. Non-nutritive sucking will be offered using a gloved finger or pacifier (based on parental preference) immediately following administration of the complete 24 percent oral sucrose dose.
15948920|NCT03272581|Other|Functional Training|Functional training has been defined as emphasizing multiple muscle and joint activities, combining upper and lower body movements, and utilizing more of the body in each movement. The primary goal of functional training is to transfer improvement achieve in one movement to enhancing the performance of another movement by affecting the entire neuromuscular system.
15948921|NCT03272568|Drug|Recombinant FVIII Fc fusion product Eloctate|Subjects will get FVIII activity corrected from the baseline level to 100-150% with Eloctate on the first day of menstruation at the beginning of the study interventional phase. The first dose of the drug will be given in the clinics via slow injection into a vein (infusion). A short assessment of pharmacokinetics (PK) (4 time-points blood draw: 15 min, 2 hours, 4 hours, 20 hours after the infusion) will be performed to assist with subsequent dosing. 2 total doses of Eloctate likely to be given on day 1 and 3 of menstrual period. The subject will then receive three additional PK-adjusted monthly doses of Eloctate (with no less than 21 days interval).
15948922|NCT03272568|Drug|Recombinant FIX Fc fusion product Alprolix|Subjects will get FIX activity corrected from the baseline level to 100-150% with Alprolix on the first day of menstruation at the beginning of the study interventional phase. The first dose of the drug will be given in the clinics via slow injection into a vein (infusion). A short assessment of pharmacokinetics (PK) (4 time-points blood draw: 15 min, 4 hours, 48 hours, 72 hours after the infusion) will be performed (by home nursing or local lab) to assist with subsequent dosing. Single dose of Alprolix likely to be given on day 1 of menstrual period. The subject will then receive three additional PK-adjusted monthly doses of Alprolix (with no less than 21 days interval).
15948923|NCT03272568|Device|Patient-operated diagnostic device for anemia AnemoCheck.|Each AnemoCheck test kit enables patients to check hemoglobin levels by pricking their finger to draw 5 μL of blood into a capillary tube, inserting that tube into a larger tube with a pre-filled chemical solution, mixing, waiting one minute, and assessing the color change of the solution using a reference color scale card included with the kit. The test is able to subjectively differentiate low, medium and high levels of hemoglobin to diagnose anemia at home. Study participants are taught to perform a hemoglobin check every other day using Anemocheck during 2 consecutive menstrual cycles. In addition they will have hemoglobin level obtained locally (LabCorp) drawn within 4-6 hours for comparison and correlation.
15948924|NCT03272555|Other|WILD 5 Wellness Interventions|Students enrolled in the study will be asked to complete activities in five wellness elements including exercise, mindfulness, sleep, social connectedness and nutrition for 30 days.
15948925|NCT03272542|Dietary Supplement|Prebiotic: soluble corn fiber|prebiotic
15948926|NCT03272542|Dietary Supplement|Placebo: maltodextrin|placebo
15948927|NCT03272529|Other|Patient-specific simulated rehearsals|Using 3-D printing and polymer technology, the investigators' team will construct patient-specific simulated hydrogel models designed from patients' imaging, incorporating the necessary anatomy, physiology, and pathology specific to each patient. These models will be constructed at the Simulation Innovation laboratory within the Department of Urology, University of Rochester. The process involves importing DICOM files of patient participants C.T. scans into 3D processing software, creating virtual models of kidney parenchyma incorporating the kidney, urinary system, stone and abdominal wall. Surgical phantoms are then created using 3D printing and polymer hydrogels, to recreate the entire procedure.
15948968|NCT03272412|Diagnostic Test|Analysis of serum Progesterone in blood sample|Levels of progesterone will be determined on the day of embryo transfer in patients undergoing artificial endometrial preparation cycles.
15948969|NCT03272399|Other|Diet/nutrition intervention|The intervention will be administered through food products rather than dietary supplements
15948928|NCT03272529|Other|Idealized simulated rehearsals|Using 3D printing and polymer technology, the investigators' team will construct a validated generic simulated hydrogel model with a complex kidney stone, incorporating the necessary anatomy, physiology and pathology. These models will be constructed at the Simulation Innovation laboratory within the department of urology at the University of Rochester. Generic models incorporating the kidney, PCS, staghorn stone, abdominal wall, and other relevant anatomical elements (bowel, perinephric fat, solid organs and bony structures) will be constructed. Participants in his group will complete the simulation replicating all steps of the procedure of this ideal training case that is not specific to a particular patient.
15948929|NCT03272529|Other|Standard simulation|Participants recruited to this cohort will only have completed the standard prerequisite simulation training similar to the two other groups (didactic lecture, hands-on simulation training to proficiency and live case observation), that represents the current standard of care. No further simulation would be conducted in participants of this group in addition to the standard.
15948930|NCT03272516|Behavioral|Mindfulness based cognitive therapy (MBCT)|Mindfulness Based Cognitive Therapy (MBCT). This group receives 8 weeks of MBCT in addition to usual treatment (TAU). The MBCT consists of weekly group sessions of 2,5 hours, where participants receive cognitive therapy as well as mindfulness meditation. This group is also assigned homework, according to the MBCT protocol.
15948931|NCT03272516|Other|Treatment as usual (TAU)|Usual treatment prescribed by each physician, specifically interview therapy, cognitive therapy, antidepressants and/or anxiolytics as well as a mixture of all of the above.
15948932|NCT03272503|Drug|Pimozide 2mg/day (current) or 4 mg/day (study initiation)|Pimozide 2mg tablets will be taken once daily.
15948933|NCT03272503|Drug|Placebo Oral Tablet|Identical matching placebo lactose tablets
15948934|NCT03272490|Procedure|Medartis|Surgery using the medartis implant
15948935|NCT03272490|Procedure|Synthes|Surgery using the Synthes implant
15948936|NCT03272477|Drug|Perjeta Injectable Product|Single dose of 840mg (loading dose) day1 cycle 1, 420mg at day1 of each subsequent cycle, every 3 weeks. (The latter cycle is called cycle of treatment and is to be given 4 times in the neoadjuvant phase and 14 times in the adjuvant therapy phase.)
15948937|NCT03272477|Drug|Herceptin|Single dose of 8mg/kg (loading dose) day1 cycle 1; 6mg/kg at day1 of each subsequent cycle body weight every 3 weeks. (This is called cycle of treatment and is to be given four times in the neoadjuvant phase and 14 times in the adjuvant therapy phase.)
15948938|NCT03272477|Drug|Tamoxifen|20 mg per day for a total of 40 weeks in the adjuvant therapy phase.
15948939|NCT03272477|Drug|Paclitaxel|80mg/sqm, day one of each cycle, every week. This is called a cycle of treatment and is to be given for 12 weeks in neoadjuvant therapy phase.
15948940|NCT03272477|Drug|Epirubicin|12 weeks (4cycles) of max. 90mg/sqm in adjuvant therapy phase
15948941|NCT03272477|Drug|Cyclophosphamide|12 weeks (4cycles) of 600 mg/sqm i.v. on day 1+8 or 12 weeks (4cycles) of 500 mg/sqm i.v. on day 1 in adjuvant therapy phase
15948942|NCT03272477|Drug|Anastrozole|1mg per day for a total of 40 weeks in adjuvant therapy phase
15948943|NCT03272477|Drug|Letrozole|2,5 mg/day for a total of 40 weeks in adjuvant therapy phase
15948944|NCT03272477|Drug|Exemestane|25mg/day for a total of 40 weeks in adjuvant therapy phase
15948945|NCT03272477|Drug|Leuprorelin acetate|One injection of 3,75mg every month or 4 weeks in pre-menopausal women treated with aromatase inhibitors Anastrozole or Letrozole or Exemestane, for a total of 40 weeks in the adjuvant therapy phase.
15948946|NCT03272477|Drug|Goserelin|3,6mg every 28 days or 4 weeks in pre-menopausal women treated with aromatase inhibitors Anastrozole or Letrozole or Exemestane, for a total of 40 weeks in the adjuvant therapy phase.
15948947|NCT03272477|Drug|Anastrozole|1mg per day for 12 weeks in neoadjuvant therapy phase; 1mg per day for a total of 40 weeks max. in adjuvant therapy phase
15948948|NCT03272477|Drug|Letrozole|2,5 mg per day for 12 weeks in neoadjuvant therapy phase; 2,5 mg perday for a total of 40 weeks max. in adjuvant therapy phase
15948949|NCT03272477|Drug|Exemestane|25mg/day for 12 weeks in neoadjuvant therapy phase; 25mg/day for a total of 40 weeks max. in adjuvant therapy phase
15948950|NCT03272477|Drug|Paclitaxel|80mg/sqm, day one of each cycle, every week. This is called a cycle of treatment an is to be given for 12 weeks in the adjuvant phase
15948951|NCT03272477|Drug|Tamoxifen|20mg per day (given over 12 weeks in the neoadjuvant therapy phase and over 40 weeks max. in the adjuvant therapy phase.
15948952|NCT03272477|Drug|Leuporelin acetate|One injection of 3,75mg every month or 4 weeks in pre-menopausal women treated with aromatase inhibitors Anastrozole or Letrozole or Exemestane (given over 12 weeks in the neoadjuvant therapy phase and over 40 weeks max. in the adjuvant therapy phase).
15948953|NCT03272477|Drug|Goserelin|3,5mg every 28 days or 4 weeks in pre-menopausal women treated with aromatase inhibitors Anastrozole or Letrozole or Exemestane (given over 12 weeks in the neoadjuvant therapy phase and over 40 weeks max. in the adjuvant therapy phase).
15948954|NCT03272477|Diagnostic Test|Biopsy|Core biopsy at screening (outside of protocol), at week 4 after randomization, (at week 14 in addition if neoadjuvant phase is prolonged)
15948955|NCT03272477|Procedure|Surgery|Surgery at week 14 after randomization (or later, if neoadjuvant phase is prolonged)
15948956|NCT03272464|Drug|Trametinib|Trametinib may work by binding to your cancer cells to inhibit the cancer cells' signals to decrease cell growth.
15948957|NCT03272464|Drug|Dabrafenib|Dabrafenib may work by stopping your cancer cells from duplicating.
15948958|NCT03272464|Drug|INCB039110|Itacitinib may work by stopping your tumor cells from living and growing.
15948959|NCT03272451|Procedure|culprit vessel intervention|ECG guided immediate culprit vessel intervention using a single transradial guiding catheter such as MAC or JL 3.5
15948960|NCT03272451|Procedure|traditional approach|single diagnostic catheter for complete coronary angiography and guiding catheter selection for PCI
15948961|NCT03272438|Device|Accelerometer|Participants use an accelerometer to monitor their steps activity
15948962|NCT03272438|Behavioral|Step goal|Participants are given a daily step goal to aim for
15948963|NCT03272438|Behavioral|Consistent contexts|Participants plan to take steps in contexts that are similar from day to day
15948964|NCT03272438|Behavioral|Inconsistent contexts|Participants plan to take steps in contexts that vary from day to day
15948965|NCT03272425|Drug|lesinurad/allopurinol 200/300 FDC tablets|Test Drug
15948966|NCT03272425|Drug|lesinurad 200 mg|Comparator 1
15948973|NCT03272347|Drug|Islatravir|Islatravir at 0.25 mg, 0.75 mg or 2.25 mg is orally administered QD in capsule form for up to 52 weeks. After Week 60 a selected open label dose may be administered.
15948974|NCT03272347|Drug|Placebo to Islatravir|Placebo to islatravir is orally administered QD in capsule form for up to 52 weeks
15948975|NCT03272347|Drug|Doravirine|Doravirine 100 mg is orally administered QD in tablet form for up to 144 weeks
15948976|NCT03272347|Drug|Placebo to Doravirine|Placebo to Doravirine is orally administered QD in tablet form for up to 52 weeks
15948977|NCT03272347|Drug|Lamivudine|Lamivudine 300 mg is orally administered QD in tablet form for up to 52 weeks
15948978|NCT03272347|Drug|Placebo to Lamivudine|Placebo to Lamivudine is orally administered QD in tablet form for up to 52 weeks
15948979|NCT03272347|Drug|Doravirine, Tenofovir, Lamivudine|Doravirine, Tenofovir, Lamivudine consisting of 100 mg Doravirine + 300 mg Lamivudine + 300 mg tenofovir disoproxil fumarate is orally administered QD in tablet form for up to 144 weeks.
15948980|NCT03272347|Drug|Placebo to Doravirine, Tenofovir, Lamivudine|Placebo to Doravirine, Tenofovir, Lamivudine is orally administered QD in tablet form for up to 52 weeks
15948981|NCT03272347|Drug|Doravirine/Islatravir|Fixed dose combination of islatravir 0.75 mg/doravirine 100 mg orally administered QD in tablet form for 48 weeks
15948982|NCT03272334|Drug|HER2 BATs with Pembrolizumab|8 infusions of HER2 BATs with 1-3 infusions of Pembrolizumab
15948983|NCT03272321|Drug|Oxytocin|Syntocinon nasal spray
15948984|NCT03272321|Drug|Placebo|Placebo nasal spray
15948985|NCT03272295|Other|Reference cigarette|The reference product is based on a commercially-available king-size cigarette design (length 83 mm, circumference 24.6 mm) with a single segment cellulose acetate filter and tobacco blend recipe without ingredients.
15948986|NCT03272295|Other|Cigarette with carob bean extract|Based on reference cigarette with added ingredient
15948987|NCT03272295|Other|Cigarette with cocoa powder|Based on reference cigarette with added ingredient
15948988|NCT03272295|Other|Cigarette with fenugreek extract|Based on reference cigarette with added ingredient
15948989|NCT03272295|Other|Cigarette with fig juice|Based on reference cigarette with added ingredient
15948990|NCT03272295|Other|Cigarette with glycerol|Based on reference cigarette with added ingredient
15948991|NCT03272295|Other|Cigarette with guaiacol|Based on reference cigarette with added ingredient
15948992|NCT03272295|Other|Cigarette with liquorice extract powder|Based on reference cigarette with added ingredient
15948993|NCT03272295|Other|Cigarette plus I-menthol|Based on reference cigarette with added ingredient
15948994|NCT03272295|Other|Cigarette with propylene glycol|Based on reference cigarette with added ingredient
15948995|NCT03272295|Other|Cigarette with sorbitol|Based on reference cigarette with added ingredient
15948996|NCT03272295|Other|Cigarette with multiple ingredients|Based on reference cigarette plus propylene glycol, glycerol, liquorice extract powder, cocoa powder, carob bean extract, fig juice concentrate, maltol, guaiacol, geraniol, fenugreek extract.
15948997|NCT03272269|Drug|IMCY-0098|Small synthetic peptide for SC admin. Solvent: alum hydroxide
15948998|NCT03272269|Other|Placebo|Solvent: alum hydroxide
15948999|NCT03272256|Drug|IM156|Sequential 3+3 design.
15949000|NCT03272243|Procedure|short segment posterior spine fixation|
15949001|NCT03272243|Procedure|long segment posterior spine fixation|
15949002|NCT03272230|Behavioral|ECOCAPTURE|45 minutes observational session for tracking goal directed behavior into a waiting room equipped with video and sensor-based data acquisition system
15949003|NCT03272230|Behavioral|Cognitive and Behavioral experimental tasks|Cognitive and Behavioral experimental tasks to explore additional frontal cognitive and behavioral dimensions and functions
15949004|NCT03272230|Diagnostic Test|Neuropsychological assessment|MMS / MADRS / EBI / NART / Mini-SEA / BREF / HAD / MATTIS / HAYLING / STROOP / STARKSTEIN / DAS
15949005|NCT03272230|Behavioral|ICM_APATHY_TASKS|Apathy experimental task
15949006|NCT03272230|Other|MRI|T1 MRI / T2 MRI / Resting state fMRI / Multi-shell diffusion-weighted MRI
15949007|NCT03272230|Biological|Neurohormonal mechanisms|Hormonal dosage / Diabetic dosage / Ionogramme dosage / Inflammatory dosage / Hepatic dosage / Lipidic dosage / Thyroid dosage
15949008|NCT03272230|Diagnostic Test|Supplementary Neuropsychological Assessment - Parkinson's Disease|ACDD / QUIP / BIS-11 / ECMP / QUIP-RS
15949009|NCT03272217|Drug|Atezolizumab|Atezolizumab 1200 mg (flat dose) IV every 21 days
15949010|NCT03272217|Drug|Bevacizumab|Bevacizumab 15 mg/kg IV every 21 days
15949011|NCT03272204|Behavioral|No pubic hair|Natural pubic hair to fully removed pubic hair
15949012|NCT03272204|Behavioral|Pubic Hair|Removed pubic hair to natural pubic hair
15949013|NCT03272191|Procedure|Liposuction and stem cell implantation|The adipose tissue specimen will be collected mainly from the patient's abdomen using a liposuction cannula. The adipose tissue may be collected from other areas if necessary The adipose tissue is transferred to the laboratory for separation of the adipose tissue-derived stem cells, which are then transferred to an injection/infusion catheter for delivery into the akinetic myocardial scar in the region of a previous infarct
15949014|NCT03272178|Device|Depuy total knee implant|patients from Dr Nunley's clinic will get a Depuy implant
15949015|NCT03272178|Device|Triathlon total knee implant|patients from Dr Barrack's clinic will get a Triathlon implant
15949016|NCT03272165|Drug|MEDI1341|Intravenous infusion over 60 minutes
15949017|NCT03272165|Drug|Placebo|Intravenous infusion over 60 minutes
15949018|NCT03272152|Genetic|Genome-wide DNA methylation|Genome-wide DNA methylation was determined using the Infinium Human Methylation 850K BeadChip.
15949019|NCT03272139|Drug|Bupivacaine|Anesthetic that will help treat pain and sensation after shoulder arthroscopy
15949020|NCT03272139|Device|Ultrasound|Ultrasound will help guide the anesthesiologist in performing the different nerve blocks
15949021|NCT03272126|Drug|Vitamin D|vitamin D given as bolus versus daily dosing
15949022|NCT03272126|Drug|Placebo|identical looking as vitamin D
15949023|NCT03272113|Behavioral|SKIP-IT|A theory-based intervention using narrative, images and embedded behaviour change techniques, delivered via text-messaging.
15949024|NCT03272100|Procedure|flap|after flap incision , the sinus cavity was opened and then the membrane raised up
15949026|NCT03272087|Device|VATS (thoracoscopy)|50 % of patients will have performed a VATS (video-assisted thoracic surgery) thoracoscopy
15949027|NCT03272074|Other|Egg and egg white|Participants will consume either one large eggs or equivalent amount of egg white (3/4 cups) for 12 weeks. Participants will maintain their regular diet and physical activities.
15949028|NCT03272061|Other|Aerobic-based exercise program|Aerobic-based exercise will be carried out on a cycling ergometer three times a week for 30 minutes at 70% of the maximal workload. Every two weeks, the maximal workload will be reassessed, and training loads will be readjusted accordingly. Fully supervised training sessions will be performed with three-to-four study participants at a time. Subjects should maintain their body weight during the intervention period.
15949029|NCT03272048|Behavioral|Lethal Means Counseling|Lethal means counseling is broadly defined as clinician-initiated discussions that encourage an individual at risk for suicide to safely store his or her firearms. Examples in this domain include applying a gun lock, separating the gun from its ammunition, dismantling the firearm and keeping its components locked and/or separated, or safely transferring the firearm to a trusted loved one, friend, or police station until risk abates (Bryan, Stone, & Rudd, 2011; Jin, Khazem, & Anestis, 2016). Further, given that recent purchasers of firearms are at markedly increased risk of death by suicide (Wintemute, Parham, Beaumont, Wright, & Drake, 1999), anticipatory counseling on firearm safety should also be considered for at-risk individuals who do not report currently owning or having access to a firearm, but who report prior firearm ownership/access or intentions of obtaining a firearm in the future (Harvard T.H. Chan School of Public Health, 2017).
15949030|NCT03272009|Drug|EYP001a|Capsules administered orally. Number of morning and evening capsules depending on treatment arm
15949031|NCT03272009|Drug|Placebo|Placebo capsules for oral administration, identical in appearance to the EYP001a capsules
15949032|NCT03272009|Drug|Entecavir|Tablets administered orally
15949033|NCT03272009|Drug|peg-interferon alfa-2a|Ready-to-Use pre-filled syringes for subcutaneous injection
15949034|NCT03271996|Procedure|Primary closure|Asymmetric skin incision and total excision of the lesion with monopolar scalpel. Accurate hemostasis, creation of a cutaneous-subcutaneous flap, primary closure with non-absorbable sutures, optional aspiration drainage.
15949035|NCT03271996|Procedure|Fistulectomy|Evaluation of the cavity using a 0.5-1 mm metal probe which will be inserted into the skin orifice. Excision of the skin around the orifice and debridement/excision of the cavity by monopolar scalpel or Trephines
15949036|NCT03271983|Drug|Metronidazole gel 1|RLD gel
15949037|NCT03271983|Drug|Metronidazole gel 2|generic gel
15949038|NCT03271983|Drug|Metronidazole cream|generic cream
15949039|NCT03271957|Procedure|Manual rotation|Rotation of the fetal head to an anterior position at time of fuel dilation that is part of routine care
15949040|NCT03271944|Device|CO2 Laser Treatment|Fractional handpiece with CO2 laser: Fractional Ablative laser Treatment of Vulvovaginal Atrophy
15949041|NCT03271931|Behavioral|Active choice|EHR alert prompting cardiologists to make an active choice to prescribe a statin or not.
15949042|NCT03271931|Behavioral|Passive choice|EHR passive alert to cardiologists about prescribing a statin
15949043|NCT03271918|Drug|Cabergoline|
15949044|NCT03271905|Drug|salbutamol sulfate and ipratropium bromide|Nebulization with salbutamol sulfate and ipratropium bromide during mechanical ventilation.
15949045|NCT03271905|Device|Mesh nebulization|Nebulization with Mesh device.
15949046|NCT03271879|Drug|Empagliflozin at a dose of 10 mg/day|Comparing empagliflozin versus placebo on the ventricular arrhythmia burden. This study encompass 4 periods for each study subject: screening period of 8 weeks, first treatment period of 8 weeks, washout period of 4 weeks and a second treatment period of 8 weeks in a cross-over design
15949047|NCT03271866|Drug|metformin|metformin 1500mg per day
15949048|NCT03271853|Device|Sentinel BreastScan II|The SBS II will automate the recording of thermal data used in the Therma-Scan manual thermology protocol by utilizing a thermal camera sensitive to changes in breast temperature. The SBS II system uses a very sensitive thermography camera that detects and visually displays heat patterns that naturally emanate from the breast. SBS II captures this data digitally for subsequent analysis by Therma-Scan.
15949049|NCT03271827|Device|Apnoeic oxygenation|3 L/min of oxygen by nasal cannula during as apnoeic oxygenation during airway management.
15949050|NCT03271814|Biological|LPS|0.6 by/kg LPS single dose iv
15949051|NCT03271814|Other|Placebo|Sterile Water
15949052|NCT03271801|Behavioral|child health education|10, 60-minute sessions with a family-based obesity treatment program implemented for the first 40-minutes of each session followed by 20 minutes of education about a child health topic.
15949053|NCT03271801|Behavioral|skills training|10, 60-minute sessions with a family-based obesity treatment program implemented for the first 40-minutes of each session followed by 20 minutes of experiential learning about stimulus control strategies (portion size, energy density, variety).
15949054|NCT03271788|Other|Mindfulness, MBSR|Participants (stroke patients and one of their closest relatives) will conduct an MBSR Course in Phase B
15949055|NCT03271775|Other|physical therapy program (group)|Exercises group transmitted by physical therapist (Up to four participant in each group).
15949056|NCT03271775|Other|physical therapy program (computerized exercises)|Remote exercises program accompanied by a physical therapist guidance
15949057|NCT03271762|Device|percutaneous mitral valve repair with MITRACLIP NT, MITRACLIP NTR/XTR, MITRACLIP G4NT/XT, MITRACLIP G4NTW/XTW|percutaneous mitral valve repair Percutaneous MitraClip Device Implantation
15949058|NCT03271762|Procedure|cardiac surgery|mitral valve repair or mitral valve remplacement
15949059|NCT03271749|Other|PROSM guidelines for preoperative, anesthesia and postoperative care for lung resections|The PROSM guidelines is described previously in study description
15949060|NCT03271736|Behavioral|Stepping-in-place exercise with external auditory cues|The stepping-in-place exercise includes 10-session training. In each session, subjects are asked for stepping for 50 steps. In auditory cued condition, the cued frequency is set at 110% of the usual walking cadence. While in non-cued condition, we ask the subjects to step according to their own internal rhythm.
15949061|NCT03271736|Device|Transcranial magnetic stimulation (TMS)|TMS is used to assess the cortical excitability of the motor cortex. The stimulation intensity is set at 130% of the motor threshold in single-pulse condition. In paired-pulse condition, the first stimulus is set at 80% of the motor threshold and the second stimulus is set at 130% of the motor threshold.
15949063|NCT03271710|Device|peripheral balloon angioplasty|Percutaneous transluminal angioplasty (PTA) of the lower extremities
15949064|NCT03271697|Drug|Astragalus Membranaceus|This research is trying to see if AM can enhance the clinical prognosis for spontaneous aneurysm ruptured subarachnoid hemorrhage patients.
15949065|NCT03271697|Drug|Placebo|as a comparator comparing with AM group
15949066|NCT03271684|Other|self-management|one session of up to one-hour per week over a six-week period in addition to their usual rehabilitation. During each session strategies will be used to promote specific behaviors that exemplify the hallmarks of self-management. These behaviors include enabling patients to work out ways of taking control of their daily lives by setting small targets, recording their progress and problem-solving. The content of the sessions is determined by the patient and their personal goals rather than being professionally directed
15949067|NCT03271684|Other|Control|Participants will receive usual rehabilitation treatment, they will also be given a booklet with education program and exercises they can perform at home.
15949068|NCT03271671|Other|NAVA during Non invasive ventilation|NIV during respiratory failure
15949069|NCT03271671|Other|PSV during Non invasive ventilation|PSV during respiratory failure
15949070|NCT03271658|Behavioral|Web based life support patient decision aid|The web-based life support decision aid (eLSDA) was adapted from a print-based decision aid. The eLSDA includes information on the pros and cons of both life support and comfort care. The eLSDA lays out the decision about life support for an individual patient/family in a logical stepwise fashion to permit discussion, ask questions, and permit reflection on each step. At the end of the eLSDA, unmet decision-making needs are identified to seek support from the healthcare team.
15949071|NCT03271658|Behavioral|Decision coaching|During the interactive process of using the eLSDA, the study nurse provides decision coaching for patient/family, specifically a facilitated values clarification exercise.
15949072|NCT03271645|Behavioral|Space from Depression|The structure and content of the programme modules follow evidence-based principles of CBT for the treatment of depression and anxiety (NICE, 2006, 2011, 2014). The treatment comprises cognitive, emotional and behavioural components. The treatment is delivered on a Web 2.0 platform using media-rich interactive content. Each module is structured in an identical way and incorporates introductory quizzes, videos, informational content, interactive activities, as well as homework suggestions and summaries. In addition, personal stories and accounts from other clients are incorporated into the presentation of the material.
15949073|NCT03271645|Behavioral|Space from Anxiety|The structure and content of the programme modules follow evidence-based principles of CBT for the treatment of depression and anxiety (NICE, 2006, 2011, 2014). The treatment comprises cognitive, emotional and behavioural components. The treatment is delivered on a Web 2.0 platform using media-rich interactive content. Each module is structured in an identical way and incorporates introductory quizzes, videos, informational content, interactive activities, as well as homework suggestions and summaries. In addition, personal stories and accounts from other clients are incorporated into the presentation of the material.
15949074|NCT03271645|Behavioral|Space from Stress|The structure and content of the programme modules follow evidence-based principles of CBT for the treatment of depression and anxiety (NICE, 2006, 2011, 2014).The treatment is delivered on a Web 2.0 platform using media-rich interactive content. Each module is structured in an identical way and incorporates introductory quizzes, videos, informational content, interactive activities, as well as homework suggestions and summaries. In addition, personal stories and accounts from other clients are incorporated into the presentation of the material.
15949075|NCT03271645|Behavioral|Face-to-face counselling|Face-to-face counselling
15949076|NCT03271632|Biological|CAR T cells|Infusion of multi-CAR T cells
15949077|NCT03271619|Other|Surface current measurement|Measurement of surface current between electrodes placed on the chest wall during defibrillation
15949078|NCT03271606|Combination Product|ERAS|The investigators mainly used enhanced measures perioperatively in mediastinal surgery as these used in other surgery
15949079|NCT03271606|Combination Product|Traditional measures|The investigators mainly used traditional measures perioperatively in mediastinal surgery as these used in other surgery
15949080|NCT03271593|Other|No intervention|No intervention
15949081|NCT03271580|Diagnostic Test|Finger prick test for HbA1c measurement|HbA1c measurement with finger prick method
15949082|NCT03271580|Procedure|Punch Biopsy|Wound site will be anaesthetized, by punch biopsy tissue will be collected, wound site will be monitored for bleeding(if bleeding Cautery will be used to stop bleeding).
15949083|NCT03271580|Other|Vac Sponge Collection|NPWT sponge which is discarded as biological waste, will be collected for wound macrophage isolation
15949084|NCT03271580|Other|Ankle Brachial Index|Blood pressure test
15949085|NCT03271567|Diagnostic Test|Nanodisk-MS assay|Nanodisk-MS assay is a recently reported novel assay for quantitative detection of various MTB antigen peptides, using nanotechnology and mass spectrometry that showed remarkable sensitivity and specificity in diagnosing active pulmonary and extrapulmonary TB. This assay detected MTB-specific antigens, CFP-10 and ESAT-6, in patients' serum samples.
15949087|NCT03271541|Drug|Bitopertin|Bitopertin will be administered orally once daily at doses up to 120 milligrams (mg).
15949088|NCT03271528|Drug|Lacosamide|Lacosamide titration was done to a target dose of 300mg. Participants took 100 mg of lacosamide once on day 1, 100 mg twice per day from day 2 through day 6 (200 mg daily total), on day 7 the lacosamide dose was increased to 150 mg twice daily (300 mg daily total), and on day 8 the participant took one dose of 150 mg.
15949089|NCT03271528|Drug|Placebo oral capsule|Participants took a placebo oral capsule once on day 1, twice per day from day 2 to day 7, and once on day 8.
15949090|NCT03271515|Biological|anti-CD19 anti-CD20 Bispecific CAR-T|patients accept transfusion of anti-CD19 anti-CD20 Bispecific CAR-T cells.
15949091|NCT03271502|Procedure|Total intravenous anesthesia|Total intravenous anesthesia with propofol and remifentanil
15949092|NCT03271502|Procedure|Inhalation anesthesia|Inhalation anesthesia with sevoflurane and remifentanil
15949093|NCT03271489|Other|Elagolix Placebo|Tablets
15949094|NCT03271489|Drug|E2/NETA|Capsules
15949095|NCT03271489|Other|E2/NETA Placebo|Capsules
15949096|NCT03271489|Drug|Elagolix|Tablets
15949097|NCT03271476|Behavioral|EMDR psychotherapy|Visit 0 : patient inclusion (questionnaires and interview) Visit 1 : anamnesis Visit 2 : patient supporting Visit 3 : EMDR psychotherapy care Visit 4 : EMDR psychotherapy care Visit 5 : EMDR psychotherapy care and questionnaires Visit 6 : EMDR psychotherapy care Visit 7 : EMDR psychotherapy care Visit 8 : EMDR psychotherapy care ans questionnaires Visit 9 (one month after) : semi-directive interview and data recovery (questionnaires)
15949098|NCT03271463|Behavioral|Selective Control Assessment of Lower Extremity (SCALE)|Inter- and intra-rater reliability Validity: correlation analysis with Fugl-Meyer Assessment - Lower Extremity Component (FMA-LE) and 10 meter walk test (see below)
15949099|NCT03271450|Drug|Dabigatran: extended treatment (e.g at least 90 days)|90 days
15949100|NCT03271450|Drug|Dabigatran: extended treatment (e.g at least 180 days)|180 days
15949101|NCT03271450|Drug|Dabigatran: extended treatment (e.g at least 270 days)|270 days
15949102|NCT03271450|Drug|Apixaban: extended treatment (e.g at least 90 days)|90 days
15949103|NCT03271450|Drug|Apixaban: extended treatment (e.g at least 180 days)|180 days
15949104|NCT03271450|Drug|Apixaban: extended treatment (e.g at least 270 days)|270 days
15949105|NCT03271450|Drug|Rivaroxaban: extended treatment (e.g at least 90 days)|90 days
15949106|NCT03271450|Drug|Rivaroxaban: extended treatment (e.g at least 180 days)|180 days
15949107|NCT03271450|Drug|Rivaroxaban: extended treatment (e.g at least 270 days)|270 days
15949108|NCT03271450|Drug|Edoxaban: extended treatment (e.g at least 90 days)|90 days
15949109|NCT03271450|Drug|Edoxaban: extended treatment (e.g at least 180 days)|180 days
15949110|NCT03271450|Drug|Edoxaban: extended treatment (e.g at least 270 days)|270 days
15949111|NCT03271450|Drug|Warfarin: extended treatment (e.g at least 90 days)|90 days
15949112|NCT03271450|Drug|Warfarin: extended treatment (e.g at least 180 days)|180 days
15949113|NCT03271450|Drug|Warfarin: extended treatment (e.g at least 270 days)|270 days
15949114|NCT03271437|Behavioral|PC-based Flash|Progressive counting with Flash technique
15949115|NCT03271437|Behavioral|EMDR-based Flash|Eye movement desensitization and reprocessing with Flash technique
15949116|NCT03271424|Diagnostic Test|Oraquick HIV Self Test - Choice|This is an oral swab in home HIV test.
15949117|NCT03271424|Diagnostic Test|Atomo HIV Self Test - Choice|This is a blood finger prick in home HIV test.
15949118|NCT03271424|Diagnostic Test|Oraquick HIV Self Test and Atomo HIV Self Test - Both|This is an oral swab in home HIV test and this is a blood finger prick in home HIV test.
15949119|NCT03271411|Behavioral|EMDR-based Flash technique|Initial EMDR session (with Flash technique) of up to three hours; about one week later, follow-up session of up to one hour
15949120|NCT03271411|Behavioral|PC-based Flash technique|Initial PC session (with Flash technique) of up to three hours; about one week later, follow-up session of up to one hour
15949121|NCT03271398|Behavioral|EMDR|Eye movement desensitization and reprocessing (intensive format)
15949122|NCT03271398|Behavioral|PC|Progressive counting (intensive format)
15949123|NCT03271385|Diagnostic Test|evaluated by the predetermined differentiating formula|After recruiting patients, collecting the baseline data, a CMR scan will be carried out and post-processed, a predetermined differentiating formula (including left ventricular morphology, ejection fraction, presence of late gadolinium enhancement, T1 value and strain data) will be used to produce a cardiac values, which is to be input into our differentiating flow.
15949124|NCT03271372|Drug|Avelumab|Given IV
15949125|NCT03271372|Other|Peripheral Blood Collection|Correlative studies
15949126|NCT03271372|Other|Placebo|Given IV
15949127|NCT03271359|Behavioral|EMDR|Initial EMDR session of up to three hours; about one week later, follow-up session of up to one hour
15949128|NCT03271359|Behavioral|PC|Initial PC session of up to three hours; about one week later, follow-up session of up to one hour
15949129|NCT03271346|Behavioral|intensive trauma-focused therapy|
15949130|NCT03271333|Other|lung function tests|Patients hospitalized realise a Resting pulmonary function tests (PFT) which include the assessment of ventilatory capacity: spirometry (forced expiratory flows and mobilisable volumes)
15949131|NCT03271320|Other|appearance scales|appearance scales : AVS; ASWAP; DAS 59
15949132|NCT03271307|Behavioral|Optimized PITC|Providers will receive training on the importance of HIV testing and their role in testing as part of OPD care and morning HIV testing will be offered. Providers will receive job aids on the importance of referring patients for HIV testing, and the study team will conduct regular monitoring and evaluation on PITC implementation.
15949133|NCT03271307|Diagnostic Test|Facility HIVST|HIVST will be carried out in a group setting among patients in the waiting area of OPD clinics. Eligible clients will receive education about HIV testing and a demonstration of how to use and interpret results of a self-test kit will occur in the group setting. Participants will use the HIVST kit in a group setting and will be given private settings (private room or booth) to interpret their results. Participants will disclose their results to their OPD provider if they choose. Routine linkage to confirmatory testing and ART initiation will be conducted.
15949134|NCT03271307|Diagnostic Test|Index HIVST|HIVST demonstration and distribution will be provided to HIV-positive clients in participating facilities to distribute to their partners. Partners who have a reactive HIVST test result, or are unable or unwilling to use HIVST, will be asked to present at the health facility for routine HIV testing. Routine linkage to confirmatory testing and ART initiation will be conducted.
15949135|NCT03271294|Device|Exair Transvaginal Mesh|Exair transvaginal mesh system for the treatment of pelvic organ prolapse
15949136|NCT03271281|Drug|One injection of 68Ga-NODAGA-E[c(RGDyK)]2|One injection of 68Ga-NODAGA-E[c(RGDyK)]2
15949137|NCT03271281|Device|PET/CT|Following injection of 68Ga-NODAGA-E[c(RGDyK)]2 the patients will be subjected to whole body PET/CT
15949138|NCT03271255|Drug|Apatinib Mesylate Tablets|Apatinib combination with FOLFIRI regimen as the second-line chemotherapy for mCRC
15949139|NCT03271255|Drug|Bevacizumab Injection|Bevacizumab combination with FOLFIRI regimen as the second-line chemotherapy for mCRC
15949170|NCT03271034|Dietary Supplement|Mediterranean diet|Participants will lose weight by utilizing a low caloric diet and meeting with a study dietitian weekly for ~4 months.
15949171|NCT03271021|Drug|FMX101|FMX101, 4% minocycline foam
15949172|NCT03271021|Drug|Vehicle Foam|Vehicle Foam
15949140|NCT03271242|Other|Systematic implementation support|Implementation support is offered by implementation trainers visiting each clinical unit every two weeks for 6 months and then monthly for 12 months. Support is given only for the practice randomly assigned to support. The aim is to engage leaders and clinicians in identifying and overcoming implementation barriers, and in building systems to support and sustain implementation. Implementation trainers from all sites are trained together and meet every 2-3 month with leaders of the implementation training for supervision, mutual discussion, and exchange of experiences. At the start of the implementation, leaders and clinicians were also invited to a workshop on the practice they have been randomly assigned to receive support for. Toolkits are made available on a website.
15949141|NCT03271242|Other|No implementation support|No implementation support is offered to clinical units for the practice randomly assigned to no implementation support, of the two practices (of the four practices in the project) that unit has chosen to implement.
15949142|NCT03271229|Biological|Concentrated Bone Marrow Aspirate (BMAC)|Participants will have a knee injected with BMAC stem cells harvested from the iliac crest
15949143|NCT03271229|Biological|Platelet-Rich Plasma (PRP)|Participants will have a knee injected with Platelet-Rich Plasma (PRP) obtained from a venous whole blood draw from the antecubital vein.
15949144|NCT03271216|Device|No intervention|no intervention
15949145|NCT03271203|Other|Michigan Hand Outcomes Questionnaire|The MHQ is a self-report measure that assesses the function of the hand(s) and/or wrist(s). The MHQ contains six distinct scales including overall hand function, activities of daily living, pain, work performance, aesthetics and subject satisfaction with hand function. In the pain scale, high scores indicate greater pain, while in the other five scales, high scores denote better hand performance.
15949146|NCT03271203|Other|Real-time data capture app|Real time data capture app is a smart-phone or web-based application which will allow the subjects to provide responses about their experience of HOA in real-time via varying video, audio, photographic and text forms.
15949147|NCT03271190|Behavioral|ENGAGE SPANISH/MUSIC|Cognitive strategies to improve attention and memory skills (21 hours), leisure activities (music lessons or Spanish lessons) (27 hours), selected videogames to practice variable attention strategies (4 hours in class + about 10 hours at home). Total of 24 2-hour in class sessions over 4 months. The training will be delivered to small groups of 5 to 8 participants by a trained therapist for formal sessions and a professional music or Spanish teacher for leisure sessions.
15949148|NCT03271190|Behavioral|ENGAGE DISCOVERY|Educational content about brain and healthy aging (21 hours), leisure activities (watching documentaries followed by group discussion and debate) (27 hours), selected non-stimulating videogames (4 hours in class + about 10 hours at home). Total of 24 2-hour in class sessions over 4 months. The training will be delivered to small groups of 5 to 8 participants by the same trained therapist as in the ENGAGE arm.
15949149|NCT03271177|Device|7F sheathless Guide Catheter|Transradial PCI will be performed with a 7F sheathless Guide Catheter
15949150|NCT03271177|Device|6F Sheath/Guide Catheter Combination|Transradial PCI will be performed with a 6F Sheath/Guide Catheter Combination
15949151|NCT03271164|Device|FBPM10 System|Application of the FBPM10 membrane followed by illumination with a multi-Light Emitting Diode (LED) lamp.
15949152|NCT03271164|Other|Massages with vitamin E cream|The other breast will be treated with wound massages with vitamin E cream.
15949153|NCT03271151|Drug|Cymbalta|"Duloxetine (Cymbalta) is a serotonin and norepinephrine dual reuptake inhibitor (SNRI) that is an effective treatment for painful diabetic neuropathy. It is approved for major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathy, fibromyalgia, and chronic musculoskeletal pain"
15949154|NCT03271151|Other|Placebo|Placebo to compare outcomes against Duloxetine
15949155|NCT03271138|Dietary Supplement|Bifidobacterium infantis NLS super strain (Natren LIFE START®2)|2 capsules, 3 times per day, for daily total of 12x10^9 CFU Bifidobacterium infantis NLS super strain
15949156|NCT03271138|Other|Placebo|2 capsules, 3 times per day, containing rice flour, hydroxypropyl and methylcellulose
15949157|NCT03271125|Behavioral|Treadmill|Participants in the experimental group received supervised treadmill training, 4-5 sessions per week. The treatment protocol was aimed at improving participants' resistance, walking velocity, balance and cognitive functions during motor and cognitive (dual) tasks. The treadmill training was carried out without body weight support but if needed the participants were attached to a safety harness.
15949158|NCT03271125|Behavioral|Resistance|Participants in the control group were treated with Resistance exercises, 4-5 sessions per week. The treatment protocol was aimed at improving strength in muscles involved in walking (hip abductors, quadriceps, plantar flexors, dorsal flexors) according to current guidelines from the American College of Sports Medicine (2009). Three sets of 10 repetitions were performed bilaterally with appropriate weights for each exercise
15949159|NCT03271112|Other|Exercise program|Measurement of physical performance before and after the 12 wks-exercice program
15949160|NCT03271099|Other|Navigator|Patient Navigation services will be provided to try to eliminate barriers in pursuing survivorship surveillance
15949161|NCT03271086|Behavioral|The StressEraser|The StressEraser is a handheld biofeedback device that measures heart rate variability (HRV). Heart rate increases during inspiration and decreases during expiration. The HRV, depicted on a miniature screen, essentially represents respirations. The investigator's prior study demonstrated that the device is easily mastered and acceptable to children above 6 years of age.
15949162|NCT03271086|Behavioral|Breathe2Relax|Breathe2Relax is a free mobile app, developed by the Dept. of Defense's National Center for Telehealth and Technology to help veterans with PTSD and others use breathing practice for stress management. This application guides users in relaxation breathing and is available for both android and iOS phones. It is adapted for children 6 years and up. For instance, the cycles can be shortened for children, there is a selection of quiet music and the user can choose backgrounds for personalization.
15949163|NCT03271086|Behavioral|Reminder text messages|Weekly texts will be sent out to parents in the technology-enhanced relaxation breathing group to as reminders to practice the daily relaxation breathing with their child.
15949164|NCT03271073|Drug|Apatinib|Apatinib,500mg,qd,po,d1-21;S1,40mg,bid,d1-14;every 21days a cycle
15949165|NCT03271060|Procedure|Posterior lumbar interbody fusion|Lumbar fusion by screws and inter vertebral cage
15949166|NCT03271060|Procedure|Inter transverse bone grafting|Inter transverse process bone grafting by bone graft from illiac crest or other sites
15949167|NCT03271047|Drug|binimetinib|Orally, twice daily.
15949173|NCT03271008|Device|Direct laryngoscopy|During the induction of general anaesthesia, the first attempt to achieve a secured airway is carried out using a size 4 (or size 3 if necessary) Macintosh blade direct laryngoscope.
15949174|NCT03271008|Device|Vividtrac videolaryngoscope|During the induction of general anaesthesia, the first attempt to achieve a secured airway is carried out using a Vividtrac videolaryngoscope connected to a tablet or smartphone.
15949175|NCT03271008|Device|KingVision videolaryngoscope|During the induction of general anaesthesia, the first attempt to achieve a secured airway is carried out using a KingVision videolaryngoscope.
15949176|NCT03270995|Behavioral|Cognitive Existential Therapy Group 1|Six group sessions of two hour each using a cognitive-existential group approach
15949177|NCT03270995|Behavioral|Supportive Therapy Group 2|Six group session of two hour each using a supportive group approach.
15949178|NCT03270982|Device|Comprehensive SRS Replacement|This system consist of a proximal humeral replacement, distal humeral replacement, or total humeral replacement.
15949179|NCT03270969|Drug|Tenofovir Disoproxil Fumarate/Emtricitabine|Participants will receive daily TDF/FTC for 14 days
15949180|NCT03270956|Biological|Renal Autologous Cell Therapy™ (REACT)|Autologous selected renal cells (SRC)
15949181|NCT03270943|Behavioral|MFY|Mindful Self-Compassion course for teens
15949182|NCT03270943|Behavioral|HLG|Healthy Lifestyles course for teens
15949183|NCT03270930|Procedure|Emergency laparotomy|All patients in study underwent emergency laparotomy within 24 hours of presentation after adequate resuscitation of minimum 1 hour.
15949184|NCT03270917|Procedure|Parenchymal preserving postero-superior liver segment resection|Parenchymal preserving liver segment resection of one or two of the postero-superior liver segments (4A, 7 or 8).
15949185|NCT03270904|Device|Moleculight i:X™ fluorescence imaging|Moleculight i:X™ is a hand held device that emits violet blue light. By controlling distance from the wound and ambient light, Moleculight i:X™ identifies bacteria above a pre-determined concentration by identifying natural fluorescence in the bacteria cell wall.
15949187|NCT03270878|Drug|Glasdegib Oral Tablet|Subjects will receive a single 100 mg oral tablet of glasdegib under fasted conditions, either in study period 1 or 2, depending on randomization.
15949188|NCT03270878|Drug|Glasdegib IV infusion|Subjects will receive a 50 mg IV infusion of glasdegib over approximately 1.25 hours, in the fasted state, in either period 1 or 2 based on randomization.
15949189|NCT03270865|Device|PAF (Positioning And Fixation device)|"Up to 60 Subjects will be evaluating for positioning accuracy and comfort by comparing different methods utilizing the PAF device. Some methods of positioning will be applied and compare for each usability factor X, Y, Z location, and fixation.
~The patient will be evaluated before pupil dilation. VA and ophthalmic diagnoses will be recorded.
~Pupil position will be recorded using 3 commercial off the shelf cameras when the subject is performing simple ergonomic tasks while looking at a screen presenting images. Each testing session will be limited 20 min long. Subjects will be able to rest within the testing session if required. Total session time per patient will not exceed 30 minutes."
15949190|NCT03270852|Device|Enhanced reality|"This prototype is developed by investigators for the first time so that it have no trademark or manufacturer name yet.
~The patient sits facing the horizontal desk with the ER therapy device, and then raises the wrist joint to the fixed base. The hand, wrist, and distal forearm to be treated are positioned below the ER medical camera so that the wrist is visible on the screen. Fix the wrist and wrist joint using Velcro. When treating the distal forearm, detach the wrist fixing Velcro."
15949191|NCT03270852|Other|No Enhanced reality|Identical rehabilitation without enhanced reality
15949192|NCT03270839|Drug|Bonine 25Mg Chewable Tablet|Motion sickness drug
15949193|NCT03270839|Drug|Kwells|Motion sickness drug
15949194|NCT03270839|Drug|Placebo Oral Tablet|No active substance in the tablet
15949195|NCT03270813|Behavioral|Relaxation training plus RAGE-Control|RAGE-Control is a biofeedback videogame in which players shoot at enemies while avoiding allies. The player's baseline heart rate is taken before the game and entered into the computer. During the game, the player wears a heart rate monitor, and if the player's heart rate rises above baseline, they are unable to shoot. The player must use relaxation skills to decrease their heart rate below the baseline before they can resume play. Participants will undergo relaxation training during each of 6 sessions, and then practice the skills they learned while playing the RAGE-Control videogame.
15949196|NCT03270813|Behavioral|Relaxation training plus Sham Videogame|The Sham videogame is a videogame in which players shoot at enemies while avoiding allies. The player wears a heart rate monitor during the game, but the heart rate does not affect the functioning of the game in any way. Participants will undergo relaxation training during each of 6 sessions, and then practice the skills they learned while playing the Sham videogame.
15949197|NCT03270800|Biological|CTA control|Sublingual and intradernal application of a mucosal adjuvance, drug product is not yet on the market.
15949198|NCT03270800|Biological|IMX101 vaccine|Sublingual and intradermal application of a vaccine, drug product is not yet on the market.
15949199|NCT03270787|Drug|Placebo|Drug: Placebo Placebo,10pills,tid,treat 1 weeks.
15949200|NCT03270787|Drug|Compound danshen dripping pills|Drug: Compound danshen dripping pills Compound danshen dripping pills,10pills,tid,treat 1 weeks.
15949201|NCT03270748|Drug|GvHD prophylaxis|Cyclophosphamide 50 mg/kg intravenously day+3 and +4 (total dose:100 mg/kg).
15949202|NCT03270735|Drug|Snake venom thrombin (Treatment)|Snake venom thrombin
15949203|NCT03270735|Drug|Placebo|No snake venom thrombin
15949204|NCT03270722|Device|FLIP topography|During upper endoscopy, the FLIP topography balloon will be advanced into the esophagus and inflated, providing additional information about the distensibility of the esophagus. This generally takes about 5 extra minutes and no complications have been reported. Theoretical complications include bleeding, infection, risk with extra anesthesia time, and putting a hole in the esophagus.
15949495|NCT03268291|Other|Standard outpatient observation|Outpatient management according to Ministry of health standards
15949205|NCT03270722|Procedure|Upper Endoscopy|A standard upper endoscopy will also be done in all patients. A small scope will be passed via the mouth to examine the esophagus, stomach, and first part of the small intestine. The risks of this procedure include the risks associated with anesthesia, a small risk of bleeding, infection, and a very small risk of putting a hole in the gastrointestinal tract.
15949206|NCT03270709|Drug|Vitamin D3 450,000 IU orally|Study subjects will receive 2 tablets of vitamin D3 for a total of 450,000 IU by mouth.
15949207|NCT03270696|Drug|administration of propofol and rocuronium|compare the tidal volume applied from starting facemask ventilation under 15cmH2O of PCV for 1 minute according to administrating propofol and rocuronium simultaneously, or ordinally
15949208|NCT03270657|Device|IPG; RC+S|We will measure the effects of varying stimulation parameters on the neural activity in subjects with Parkinson's disease (PD).
15949209|NCT03270644|Drug|Lasmiditan|Administered orally
15949210|NCT03270644|Drug|Propranolol|Administered orally
15949211|NCT03270631|Other|FM and MCE|Treatments (FM and MCE) are given individually and as in a normal clinical physical therapy setting.
15949212|NCT03270631|Other|FM and sham-MCE|Treatments (FM) are given individually and as in a normal clinical physical therapy setting. Sham-MCE is general exercises.
15949213|NCT03270631|Other|MCE and sham-FM|Treatments (FM and MCE) are given individually and as in a normal clinical physical therapy setting. Sham-FM is similar to trigger point treatment with treated points randomized.
15949214|NCT03270631|Other|Sham-MCE and sham-FM|Sham-FM is similar to trigger point treatment with treated points randomized. Sham-MCE is general exercises.
15949215|NCT03270618|Device|CAD/CAM Surgical Template|The templates were designed based on virtual planning and manufactured using three-dimensional printing technique. The template is designed to assist the surgeon to perform the osteotomy and predrill the screw holes to guide the distractor position.
15949216|NCT03270605|Procedure|Myomectomy|Surgical removal of uterine fibroid
15949217|NCT03270592|Other|Service dog|Use of a individualized certified service dog
15949218|NCT03270579|Drug|[18F]JNJ-64511070|An IV injection of 185 MBq [18F]JNJ-64511070 will be administered.
15949219|NCT03270566|Device|Domestic ion-exchange water softener|Ion-exchange water softeners exchange calcium and magnesium, amongst other divalent cations, for monovalent sodium cations using a polystyrene resin. The sodium ions come from sodium chloride (common salt). The salt needs to be topped up every 3-4 weeks and sufficient quantities of block salt will be supplied to participants. The water softener used in this study does not require electricity and has two cylinders of resin which are used alternately. A control valve alternates the flow between the two cylinders and ensures a constant supply of regenerated resin. Ion-exchange water softeners typically reduce downstream water hardness to close to zero.
15949220|NCT03270553|Drug|plazomicin|single intravenous dose
15949221|NCT03270553|Drug|metformin|single oral dose
15949224|NCT03270514|Drug|Exparel Injectable Product|Liposomal bupivacaine 20 cc (226 mg) + Bupivacaine Hydrochloride 0.25% 40 cc (100 mg) + made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
15949225|NCT03270514|Drug|Bupivacaine Hydrochloride|Bupivacaine 0.25% 2 mg/kg not to exceed 150 mg - made up to made up to calculated volume with normal saline solution based on the length of the incision and number of chest tubes (20 cc per tube + 20cc per inch of incision)
15949226|NCT03270501|Drug|Golimumab|"Axial spondyloarthritis patients who don't have a good treatment response on 2 NSAIDs, will be treated with golimumab. After remission, the therapy will be stopped.
~All patients will undergo a ileocoloscopy at baseline and, if positive, at time of remission."
15949227|NCT03270488|Other|Laser|Laser (power of 3.0w).
15949228|NCT03270488|Other|Placebo|Laser (power 0,0w)
15949229|NCT03270475|Other|exercise training|subjects complete 4-5 weeks of training
15949230|NCT03270462|Drug|Envarsus XR|Pilot study documenting the neurotoxic side effects including tremors in patients with stable graft who are receiving Tacrolimus (Envarsus XR) following kidney transplantation. Standardized questionnaire will be used to document these symptoms.
15949231|NCT03270449|Other|Multidisciplinary intervention|10 week multidisciplinary education and exercise
15949232|NCT03270436|Behavioral|Wholeness, Oneness, Righteousness, Deliverance Diabetes Prevention Program|Faith based diabetes curriculum that teaches participants to connect faith and health.
15949233|NCT03270436|Behavioral|Partnership for Improving Lifestyle Intervention Diabetes Prevention Program|Family and community based diabetes prevention curriculum that teaches participants to engage their social support to have a healthy weight.
15949234|NCT03270423|Device|PathMate2|To improve self-regulation of overweight adolescents and subsequently their weight status, we tested, whether a biofeedback relaxation exercise decreases stress and whether relaxation services as well as sensor data integration implemented in a novel Smartphone App supported intervention have effects on stress, physical activity and weight outcomes. During the intensive phase of 6 months, patients of the intervention group (IG) are equipped with a smartphone and a specially designed chat App with game character, which encourages them through a virtual coach to achieve daily activity, healty lifestyle or relaxation challenges and earn virtual rewards, to increase adherance to the health information system.
15949235|NCT03270423|Device|PathMateS|Overweight or obese adolescents of the treatment as-usual group (CG) have monthly visits on site during the intensive phase. Counseling for physical activity, healthy eating and lifestyle as well as psychosocial wellbeing is provided by a pediatrician.
15949236|NCT03270410|Other|Data collection|"After parental information and collection of their non-opposition, the data of the daily cardio-respiratory recordings of the newborns hospitalized in the units of Neonatology are collected and analyzed.
~At the same time, a video recording is set up. This video recording does not modify the care provided for the child, the organization of the day with nursing and parental care."
15949237|NCT03270397|Behavioral|"Academic course The group- theory and practice"|"Active participation in the course The group- theory and practice."
15949458|NCT03268629|Behavioral|CBT-I|The CBT-I program was delivered to groups of 10-15 individuals over the course of eight, weekly, 2-hour sessions, for a total of 16 contact hours.
15949238|NCT03270384|Device|Urotronic Drug Coated Balloon (DCB)|The Urotronic Drug Coated Balloon (DCB) is a guidewire compatible catheter with a tapered atraumatic tip. The distal end of the catheter has an inflatable balloon coated with a proprietary coating containing the drug paclitaxel that facilitates the drug's transfer to the urethral wall upon inflation.
15949239|NCT03270371|Device|Medium cut off dialysis|Hemodialysis
15949240|NCT03270371|Device|Standard High Flux Dialyzer|Hemodialysis
15949241|NCT03270358|Procedure|Blood sampling in arterioveinous fistula without stenosis|"Plasmatic osteopontin level (ng/ml) collected in the patient's arteriovenous fistula.
~Blood sampling in arterioveinous fistula right before a dialysis session"
15949242|NCT03270358|Procedure|Blood sampling in arterioveinous fistula with stenosis|Blood sampling in arterioveinous fistula right before the surgery for stenosis of the fistula
15949243|NCT03270332|Drug|Albuterol|inhalation of 270μg albuterol through a spacer
15949244|NCT03270332|Drug|Placebo|inhalation of placebo through a spacer
15949245|NCT03270293|Device|Profhilo|
15949246|NCT03270280|Drug|Nigella Sativa Oil|The individuals will apply 55 drops of Nigella sativa Oil on gingivae twice daily for two weeks
15949247|NCT03270280|Drug|Normal saline|The individuals will apply 55 drops of Normal saline on gingivae twice daily for two weeks
15949248|NCT03270267|Other|Questionnaires|
15949249|NCT03270254|Device|light activated dye photodynamic therapy (PDT)|light activated dye photodynamic therapy-PDT to periodontal pockets
15949250|NCT03270241|Device|Phototherapy (NB-UVB) via the 3 Series PC & SP phototherapy cabinet|This is an investigator-initiated, single-blinded, ascending dose study of NB-UVB treatment for Vitiligo in adults of 3 treatments for one week. It is designed to measure the molecular changes and re-pigmentation in affected and normal skin of participants with Vitiligo and normal skin in healthy participants.
15949251|NCT03270228|Other|Nonspecific pleuritis after VATS thoracoscopy|Patients with a pleural effusion with unknown origin after a VATS thoracoscopy is classified as nonspecific pleuritis.
15949252|NCT03270215|Procedure|Computed tomography|The diagnostic power to discriminate malignant from nonmalignant causes of e pleural effusion
15949253|NCT03270202|Behavioral|PAI group|"physical activity defined as 100 weekly PAI during 1 year
~smartphone application and a user-friendly activity wristband (Mio PAI Slice)"
15949254|NCT03270202|Behavioral|Usual care|Participants will be informed about, and encouraged to be active according to current recommendations for physical activity from the health authorities.
15949255|NCT03270189|Device|prism glasses|orthoptic treatment by wearing prisms when writing
15949258|NCT03270163|Diagnostic Test|Transcutaneous electrical stimulation|"The following tests and measurements will be carried out on the patient within 3 days of inclusion and again between the 4th and 6th day after inclusion and upon awakening:
~three simple electrical stimulations,
~three electrical doublets at the frequency of 100Hz
~For each type of electrical stimulation, the stimulations will be carried out 3 times and reproduced at 1 hour intervals."
15949259|NCT03270163|Diagnostic Test|Magnetic stimulation|"The following tests and measurements will be carried out on the patient within 3 days of inclusion and again between the 4th and 6th day after inclusion and upon awakening:
~three simple magnetic stimulations,
~three magnetic doublets at the frequency of 100Hz
~For each type of magnetic stimulation, the stimulations will be carried out 3 times and reproduced at 1 hour intervals."
15949260|NCT03270163|Diagnostic Test|ultrasound measurement|The ultrasound measurement of the thickness of the quadriceps muscle will be carried out on the patient within 3 days of inclusion and again between the 4th and 6th day after inclusion and upon awakening.
15949261|NCT03270150|Device|BTL-899|BTL-899
15949262|NCT03270137|Device|repetitive transcranial magnetic stimulation- IDLPFC|Repetitive transcranial magnetic stimulation (rTMS) at 5Hz administered over left dorsolateral prefrontal cortex (lDLPFC). Repetitive transcranial magnetic stimulation (rTMS) at 5Hz administered over left dorsolateral prefrontal cortex (lDLPFC) compared to six regions protocol, divided in two sub-conditions: day 1 (Broca area, Wernicke area and lDLPFC) alternated by day 2 (left and right parietal association cortex, and right dorsolateral prefrontal cortex [rDLPFC]). Main outcomes will be evaluated at ending of 15 rTMS sessions and 4 weeks after.
15949263|NCT03270137|Device|repetitive transcranial magnetic stimulation - Six regions|Repetitive transcranial magnetic stimulation (rTMS) at 5Hz administered on six regions protocol, divided in two sub-conditions: day 1 (Broca area, Wernicke area and lDLPFC) alternated by day 2 (left and right parietal association cortex, and right dorsolateral prefrontal cortex [rDLPFC]). Main outcomes will be evaluated at ending of 15 rTMS sessions and 4 weeks after.
15949264|NCT03270124|Behavioral|Daily Activity Goal|Patients are given a tailored daily activity goal in terms of steps per day for which to aim.
15949265|NCT03270124|Behavioral|Resistance Exercises|Patients will instructed to perform 3 different resistance exercises targeting muscles pertinent to activities of daily living on 6 out of 7 days a week.
15949266|NCT03270124|Behavioral|Daily Activity Recording|A Fitbit will be worn by all participants to record daily activity.
15949267|NCT03270111|Behavioral|Supervised Exercise|Participants will take part in supervised exercise activities two times per week at a YMCA. Length of the activity will be increased during participation in study. Participants will start at 40 minutes per week and work their way up to 120 minutes per week.
15949268|NCT03270111|Behavioral|Home-based Exercise|Aerobic exercise activities to be completed at home. Participants will be asked to start out doing 60 minutes at home and work up to 180 minutes of purposeful aerobic home exercise per week.
15949269|NCT03270111|Behavioral|Reduced Energy Diet|Diet is a nutritionally balanced, reduced energy diet recommended by the Academy of Nutrition and Dietetics.
15949270|NCT03270111|Behavioral|Group Phone Calls|Sessions are weekly months 1-3 and every other week months 4-6. The calls will discuss lifestyle changes specific to participants and cover the effects of diet, physical activity, and weight on breast cancer risk, as well as body image and emotional eating.
15949271|NCT03270098|Behavioral|Aerobic Exercise|Trainer-led one hour aerobic exercise sessions, three times per week, over 12 weeks.
15949272|NCT03270098|Behavioral|Stretching and Toning Exercise|Trainer-led one hour stretching-and-toning exercise sessions, three times per week, over 12 weeks.
15949488|NCT03268382|Drug|APR-246|Intravenous infusion
15949273|NCT03270085|Drug|Colesevelam|Colesevelam (Welchol) is approved by the Food and Drug Administration (FDA) for the treatment of high blood cholesterol levels and to treat type 2 diabetes however, Colesevelam is not approved for the use proposed in this study and is considered investigational.
15949274|NCT03270085|Other|Placebo|A placebo looks exactly like the study drug, but it contains no active ingredient. This is used to learn if the effects seen in research participants are truly from the study drug.
15949278|NCT03270046|Procedure|Water enema|Addition of water enema in standard PEG preparation in participants scheduled for CRC screening.
15949279|NCT03270033|Drug|Dexamethasone|0.4 millilitres (mL) of 10 milligram per mL sterile, preservative free solution diluted in 50 or 100mL of normal saline and administered once, over approximately 15 minutes, in the immediate preoperative period.
15949280|NCT03270033|Drug|Dexmedetomidine|0.5 millilitres (mL) of 100 microgram per mL sterile, preservative free solution diluted in 50 or 100mL of normal saline and administered once, over approximately 15 minutes, in the immediate preoperative period.
15949281|NCT03270020|Drug|Denosumab 70 MG/ML [Xgeva]|As already described in arm description
15949282|NCT03270007|Drug|Vinorelbine|different from primary chemotherapy(containing anthracycline or paclitaxel)
15949283|NCT03269994|Drug|Cefoxitin|Participants will receive one dose of cefoxitin within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time.
15949284|NCT03269994|Drug|Piperacillin-tazobactam|Participants will receive one dose of piperacillin-tazobactam within 1 hour of incision time, redosed every 2-4 hours in the operating room until closure of the incision, and discontinued within 24 hours after anesthesia end time.
15949285|NCT03269981|Radiation|Whole breast irradiation|Radiotherapy to the whole breast alone.
15949286|NCT03269981|Radiation|Whole breast and nodal irradiation|Radiotherapy to the whole breast and regional lymph nodes.
15949287|NCT03269968|Device|Negative pressure wound therapy (PREVENA Incision Management Therapy System)|After cesarean delivery, women in the intervention group will receive PREVENA Incision Management Therapy System.
15949288|NCT03269968|Device|Standard dressing|After cesarean delivery, women in the intervention group will receive standard dressing.
15949289|NCT03269955|Drug|Fibrinogen/thrombin-coated collagen patch|Tachosil® is cut in half and applied to the front and back of the pancreaticojejunostomy respectively, and fibrin glue is applied on it
15949290|NCT03269942|Procedure|Endovascular Flow-Diversion|Implantation of flow-diverter in treatment of complex aneurysms of anterior circulation.
15949291|NCT03269942|Procedure|Cerebral Revascularization|Cerebral revascularization with trapping of aneurysm in treatment of complex aneurysms of anterior circulation.
15949292|NCT03269929|Other|Music therapy|Subjects listened to music for 30 minutes before undergoing brachytherapy with spinal anesthesia
15949293|NCT03269929|Drug|Midazolam|Subjects received intravenous midazolam 0,02 mg/kgBW injection before undergoing brachytherapy with spinal anesthesia
15949294|NCT03269916|Other|Anti Mueller hormone|used to assess ovarian reserve parameters
15949295|NCT03269916|Other|Estrogen|used to assess ovarian reserve parameters
15949296|NCT03269916|Other|Follicle-Stimulating Hormone|used to assess ovarian reserve parameters
15949297|NCT03269916|Other|Antral alveolar cell count|used to assess ovarian reserve parameters
15949298|NCT03269903|Device|HILZO esophageal stent|A fully covered esophageal self-expandable metal stent for malignant dysphagia
15949299|NCT03269890|Procedure|Capsule and cutaneous blocks|7.5 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml for both blocks once before surgery per side
15949300|NCT03269890|Procedure|US-intermediate cervical plexus block|15 mL of 0.5% bupivacaine + Epinephrine 5 ug/ ml once before surgery per side.
15949301|NCT03269864|Procedure|perforator flaps|40 patients with post traumatic skin defect at leg and foot will be managed by perforator flaps, 20 with pedicled perforator flaps and other 20 with free perforator flaps
15949302|NCT03269851|Radiation|computed tomography|ct will be done to detect radiological risk factors for neurological deficits after thoracolumbar fractures
15949303|NCT03269838|Diagnostic Test|ECG|Primary Percutaneous coronary intervention
15949304|NCT03269812|Procedure|laparoscopic assisted pull-through oeration|Under general anesthesia and insertion of ports for laparoscopic instruments, laparoscopic assisted mobilization of sigmoid colon and dissection till pelvis and removal of a ganglionic segment of colon and laparoscopic assisted pull through of colon then colo-anal anastomosis will be done,
15949305|NCT03269799|Drug|Vitamin C 500 MG Oral Capsule|non surgical periodontal treatment+vitamin C 500 mg/day for 2 months
15949306|NCT03269799|Other|placebo|non surgical periodontal treatment+placebo for 2 months
15949307|NCT03269786|Diagnostic Test|Liver function tests (ALT,AST,ALBUMIN,BILIRUBIN,INR,PC,CBC)|Liver function tests will be assessed after endoscopic varisceal treatment for 6 monthes
15949308|NCT03269786|Device|biannual ultrasonography|portal vein diameter , portal vein velocity and flow direction, volume flow in portal vein , congetive index, spleen size.will be assessed after endoscopic varisceal treatment by using biannual ultrasonography for 6 monthes
15949309|NCT03269773|Biological|FURESTEM-AD Inj.|"0.3mL of the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions) as a single dose (total 1.5 mL).
~Treatment group: FURESTEM-AD® inj. 5.0 X 107 cells/1.5 mL"
15949310|NCT03269773|Other|Placebo|0.3mL of the following study drug is injected respectively into both upper arms, both thighs, and abdomen (total of 5 regions) as a single dose (total 1.5mL)
15949311|NCT03269760|Drug|Zolpidem|Addition of both non-pharmacologic nursing directed sleeping hygiene practices with pharmacologic zolpidem to improve sleep latency
15949312|NCT03269747|Drug|Prednisone|2 tablets of Prednisone 20 Mg in the morning
15949313|NCT03269747|Drug|Placebo|2 Placebo tablets in the morning
15949314|NCT03269721|Behavioral|Neuropsychological Assessment|Assessments include: Paper and pencil computerized measures of Memory, Language, Visuospatial Function, Executive Functioning-Processing Speed, and Attention
15949315|NCT03269721|Procedure|Spirometry|Pre and post bronchodilator spirometry will be administered according to the American Thoracic Society (ATS) guidelines.
15949316|NCT03269721|Procedure|Arterial Blood Gas|Radial artery blood sample will be collected to measure gas exchange hemoglobin; arterial oxygen and carbon dioxide will be examined as potential covariates.
15949317|NCT03269721|Procedure|Diffusion Capacity of the Lung for Carbon Monoxide|For measurement of gas exchange in the lung. DLCO adjusted for hemoglobin will be the primary variable of interest and will be examined as a potential covariate.
15949318|NCT03269721|Diagnostic Test|6 Minute Walk Test|Distance walked in 6 minutes will be the primary outcome.
15949319|NCT03269721|Procedure|Systemic Vascular Measures|Carotid artery ultrasound, pulse wave velocity, brachial artery endothelium-dependent flow mediated dilation and endothelium-independent dilation will be measured.
15949320|NCT03269721|Biological|Blood Biomarkers|High sensitivity C-reactive protein (hs-CRP), and fibrinogen will be used as indicators of systemic inflammation, complete blood count with differential (CBC with diff) will be obtained to rule out acute infection as a cause of inflammation.
15949321|NCT03269721|Behavioral|Symptom Questionnaire Measures|M.I.N.I Screen 7.0.0, Beck Depression Inventory-II (DBI-II), State Trait Anxiety Inventory (STAI), COPD Assessment Test (CAT), St. George's Respiratory Questionnaire (SGRQ), MMRC Dyspnea Scale (MMRC), Berlin Questionnaire
15949322|NCT03269721|Procedure|Brain MRI|Primary neuroimaging outcomes of interest are white matter structural integrity
15949323|NCT03269708|Behavioral|Education regarding telomere length|Teaching concepts of cellular aging and telomere length
15949324|NCT03269695|Drug|PF-06687234|SC QW
15949325|NCT03269695|Drug|Placebo|SC QW
15949326|NCT03269682|Device|3D PD T1 MRI sequence|After MRI has been performed (about 5 minutes of additional time compared to the usual sequences), a double reading of the MRI will be performed by two radiologists (1 experienced and 1 junior).
15949327|NCT03269669|Drug|Bendamustine Hydrochloride|Given IV
15949328|NCT03269669|Drug|Cyclophosphamide|Given IV
15949329|NCT03269669|Drug|Doxorubicin Hydrochloride|Given IV
15949330|NCT03269669|Drug|Lenalidomide|Given PO
15949331|NCT03269669|Biological|Obinutuzumab|Given IV
15949332|NCT03269669|Drug|Prednisone|Given PO
15949333|NCT03269669|Drug|Umbralisib|Given PO
15949334|NCT03269669|Drug|Vincristine Sulfate|Given IV
15949335|NCT03269643|Device|Investigational Group|The RHEA device and Philips Patient Monitor MX400 are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.
15949336|NCT03269643|Device|Reference group|The reference device Earlysense 2.0 system(vital sign monitoring system) and Philips Patient Monitor MX400 are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.
15949337|NCT03269630|Other|No intervention. Biospecimen collection only|Biospecimen collection
15949338|NCT03269617|Dietary Supplement|Bacteriophage mixture|Four bacteriophage strains: LH01-Myoviridae, LL5-Siphoviridae, T4D-Myoviridae, and LL12-Myoviridae.
15949339|NCT03269617|Other|Placebo Control|Placebo control capsule consisting of rice maltodextrin
15949340|NCT03269604|Procedure|Prophylactic antibiotic during five days previous to the procedure|Prophylactic antibiotic during five days previous to the procedure.
15949341|NCT03269604|Procedure|Prophylactic antibiotic during three days previous to the procedure|Prophylactic antibiotic during three days previous to the procedure.
15949342|NCT03269604|Procedure|Only a single dose of Prophylactic antibiotic|This group will receive a single dose of antibiotic 90 ± 20 minutes prior to the start of the surgical procedure (incision)
15949343|NCT03269591|Device|Pulsed electromagnetic field|EASY Qs portable (by ASA, Italy)
15949344|NCT03269591|Drug|diclofenac tablets|drugs
15949345|NCT03269591|Diagnostic Test|Visual analogue scale|a graphic rating scale
15949346|NCT03269591|Diagnostic Test|Progesterone blood level|blood test
15949347|NCT03269591|Diagnostic Test|Menstrual symptom questionnaire|questionnaire
15949348|NCT03269565|Biological|BCD-100|Anti-PD-1 monoclonal antibody
15949349|NCT03269552|Drug|Carfilzomib|Given IV
15949350|NCT03269552|Other|Laboratory Biomarker Analysis|Correlative studies
15949351|NCT03269552|Biological|Rituximab|Given IV
15949352|NCT03269539|Other|MRI Imaging|
15949353|NCT03269526|Drug|EGFR BATs after standard of care chemo|Subjects will receive one dose of standard of care chemotherapy prior to twice weekly or weekly infusions of EGFR BATs for 4 weeks.
15949354|NCT03269513|Behavioral|Physical Exercise|The sessions will last two hours (one hour of physical exercise and the second time divided into nutritional counseling, postural, psychological and oral) with a frequency of three times a week.
15949355|NCT03269500|Other|use of nutrition education tools|"Use of different nutrition education tools :
~General advice: feeding seniors
~Oral supplementation: instructions for use
~Information about enriched food
~Food modified in texture: chopped masticatory disorders, chopped swallowing disorders, co-mingled
~How should I drink? : With stimulus, texture syrup / nectar, velvety texture, texture compote / cream
~Recipe booklets for people to easily eat (chewing disorders) or recipe with molded texture (swallowing disorders)"
15949356|NCT03269474|Procedure|Experimental Group|Subjects with EB diagnosis
15949357|NCT03269461|Device|Angiography and Optical Coherence Tomography evaluations|coronary stent implantation followed by Angiography and Optical Coherence Tomography evaluations
15949358|NCT03269448|Diagnostic Test|Peripheral venous blood sampling|Blood collected from peripheral venous (extremities) and central venous (central catheter) for blood gas analyses
15949359|NCT03269435|Procedure|Greater occipital nerve block with bupivacaine|This is a type of peripheral nerve block. 3cc of 0.5% bupivacaine will be injected adjacent to the greater occipital nerve block blaterally
15949360|NCT03269435|Drug|Metoclopramide|Metoclopramide 10mg IV will be administered over 15 minutes
15949361|NCT03269422|Radiation|MR-based image-guided, intensity-modulated radiotherapy|Patients will receive a standard dose of 8 Gy/fraction for five fractions for a total dose of 40 Gy to the prostate with a simultaneously delivered boost of 9 Gy for five fractions (clinically non-standard dose of 45 Gy total) to a single dominant lesion with a maximum dimension of at least 0.5 cm as determined on pre-treatment diagnostic T2 MRI imaging.
15949362|NCT03269409|Other|Lactated Ringers|Approximately 5 mls of lactated ringers will be injected after decompression into the hip that does not receive adipose derived regenerative cells.
15949489|NCT03268382|Drug|Pegylated Liposomal Doxorubicin Hydrochloride (PLD)|Intravenous infusion
15949363|NCT03269409|Device|The Celution 800/GP System (Cytori Therapeutics)|The Celution 800/GP System will be used for the preparation of adipose derived regenerative cells from lipoaspirate. The adipose derived regenerative cells will then be transplanted into the hip, post decompression.
15949364|NCT03269409|Biological|Adipose Derived Regenerative Cells (ADRC)|Subjects in this arm will have Adipose Derived Regenerative Cells (ADRC)harvested through autologous liposuction and processed outside the body using The Celution 800/GP System (Cytori Therapeutics) before having approximately 5 mls. of ADRCs transplanted into the femoral head after standard of care hip decompression.
15949365|NCT03269396|Procedure|Larynx Allograft Transplantation|This study is a prospective clinical trial designed to assess the efficacy and safety of laryngeal transplantation. A total of 10 patients will be enrolled over a five-year timeframe. Study length is 5 years.
15949366|NCT03269383|Drug|Bupivacaine|Patients will receive a stellate ganglion block using 10 ml of 0.5% bupivacaine
15949367|NCT03269383|Other|Saline|Patients will receive a stellate ganglion block using 10 ml of 0.9% saline
15949368|NCT03269370|Behavioral|Anchors Away|Modular Cognitive Behavioral Therapy delivered through a mobile app.
15949369|NCT03269370|Behavioral|Parent Enhanced Anchors Away|Modular Cognitive Behavioral Therapy delivered through a mobile app. Extra modules will focus specifically on parenting skills relevant to having an anxious child.
15949370|NCT03269370|Behavioral|Self-Help E-Book|"Parents will read Helping Your Anxious Child: A Step-by-Step Guide (Rapee, Wignall, Spence, Lyneham, & Cobham, 2008)"
15949371|NCT03269357|Other|LARC forward structured contraceptive counselling|Training of health care providers (HCPs), use of information material and counselling tools
15949372|NCT03269344|Drug|Gabapentin|Gabapentin is an anticonvulsant and has been used to manage neuropathic pain and is FDA-approved for the treatment of post-herpetic neuralgia and partial onset seizures
15949373|NCT03269344|Drug|Placebo Oral Capsule|Placebo
15949374|NCT03269331|Behavioral|CTEP EBP Immersion|36 continuing ed credits, virtual library access, collaboration with expert mentors
15949375|NCT03269318|Drug|Montelukast or Salmeterol or Theophylline or Steroid|Medication will be patient specific according to their current medication, clinical symptoms and genotype. It will be from a choice of; leukotriene receptor antagonist (montelukast), long-acting beta2 agonist (salmeterol), theophylline or increase dose of inhaled steroid.
15949376|NCT03269279|Drug|Mifepristone|Medication used in conjunction with misoprostol for abortion
15949377|NCT03269279|Drug|Misoprostol|Medication used in conjunction with mifepristone for abortion
15949378|NCT03269266|Diagnostic Test|Scrub Typhus RDT Test|"A transfer pipette or loop will be used to transfer 10 µL of whole blood from a finger prick to the sample pad area on the scrub typhus test strip and the test will be performed on site according to the manufacturer's instructions. Tests will be read by two independent readers and results recorded as positive, negative or invalid.
~In patients with a skin eschar a sterile surgical blade will be used to gently scrape the surface of the eschar. Scrapings will be stored in a cryotube containing 95% ethanol and stored at -80°C for future analysis (PCR genotyping ± whole genome sequencing) to confirm the presence of Orientia tsutsugamushi."
15949379|NCT03269240|Behavioral|Acquisition of Knowledge and clinical skills|LDHF is a novel training approach that is being compared to the traditional training approach
15949380|NCT03269240|Other|Onsite training|Participants are training at their health facilities
15949381|NCT03269240|Other|Off-site training|Participants from different health facilities are gathered together in a central location for training, away from their workplaces
15949382|NCT03269227|Radiation|Accelerated hypofractionation with Tomotherapy|"Tomotherapy TPS will be used for treatment plannings. Patient' set-up daily control through Tomo-image (CT megavoltage) immediately before each sitting of all the patients.
~Prescription doses:
~Prescription dose to the target: 30 Gy in 5 daily fraction (at the reference isodose 60-70%) with an internal increasing inhomogenous dose of up to 37.5 Gy-40 Gy for GTV.
~Steroids (methylprednisolone 4 mg daily) should be used from day 1 of radiotherapy to day + 30 after the end of the treatment."
15949383|NCT03269214|Drug|Topical Phenytoin 5%|Patients received topical Phenytoin 5%+ Tetracycline after necrotic bone debridement .
15949384|NCT03269175|Other|Brain MRI|Brain MRI will be performed
15949385|NCT03269175|Other|Blood sampling|Blood samples will be taken
15949386|NCT03269162|Drug|Jinfukang Koufuye|30ml per time, tid, po (d6-21, q21)
15949387|NCT03269162|Drug|Docetaxel|75mg/m2,ivgtt 30mins, d1
15949388|NCT03269162|Drug|Pemetrexed|500mg/m2, ivgtt 30mins, d1
15949389|NCT03269162|Drug|Cisplatin|75mg/m2, ivgtt >2h, d1
15949390|NCT03269149|Other|Adapted Tango Dance|20 improvisational, 90-minute adapted tango dance sessions over a 12-week period. Classes begin with a 20-minute standing warm-up followed by partnering and rhythmic exercises. Next, novel step elements are introduced and participants will be taught how to combine the new steps with previously learned steps via improvisation. Caregivers will dance with each other or undergraduate /graduate student volunteers. Music will be played throughout classes and artistic expression, i.e., attention to aesthetics, and improvisation, will be encouraged.
15949391|NCT03269149|Behavioral|Educational lectures|Participants will take part in at least 20 educational lectures offered twice per week over 12 weeks. Classes will also be 1.5 hours long and will involve lecture, partnered and group learning and extensive Q&A will be encouraged.
15949396|NCT03269123|Device|Pressop 1|A pressure device attached to the spectacles which mimics a sensory trick (geste Antagoniste)
15949397|NCT03269110|Diagnostic Test|SRS 2, CBCL, BRIEF-P|This study does not involve an intervention.
15949398|NCT03269084|Other|No intervention. DIPP is an observational study.|
15949490|NCT03268369|Radiation|MRI of the brain|to eliminate a structural intra-cerebral lesion
15949491|NCT03268369|Radiation|PET scan [18F]F-A-85380|exam performed after iv injection of 200 MBq [18F]F-A-85380
15949399|NCT03269071|Drug|human fetal-derived Neural Stem Cells (hNSCs)|"The Drug Product (DP) can be classified as an ATIMP belonging to the class of Cell Therapy Medicinal Products (EU law). The ATIMP consists of human fetal-derived Neural Stem Cells (hNSCs) re-suspended in their final formulation medium as defined in the Investigational Medical Product Dossier (IMPD).
~For dosage indications, see specific Treatment Cohorts (TC), from A to D.
~The product will be administered intrathecally through lumbar puncture."
15949400|NCT03269058|Drug|Dapagliflozin|Dapagliflozin 10 mg daily per os
15949401|NCT03269058|Drug|Placebos|Placebo of Dapagliflozin per day per os
15949402|NCT03269045|Drug|ORL-1B|Oral ORL-1B
15949405|NCT03269019|Diagnostic Test|HIT with thrombosis|Testing thrombin-antithrombin complex, d-dimer, fibrin degradation products and Thrombelastograghy.
15949406|NCT03269006|Device|Inesfly Paint|"Inesfly 5AIGRNG TM paint contain Alphacypermethrin 0.7%; D-Allethin 1.0% and Pyriproxyphen (0.063%).
~Others intervention such as IRS, ITN and IDWLcontain Delthamethrin"
15949407|NCT03269006|Device|IDWL (1m)|Install durable wall lining up to one meter from the floor of the intervention room containing deltamethrin to kill immature stage and as well as adult sand flies
15949408|NCT03269006|Device|ITN (KO-Tab 123)|Impregnation of existing bed net by the insecticide tablet, K-O Tab 1-2-3 containing deltamethrin
15949409|NCT03269006|Device|IRS (Delthamethrin)|Indoor residual spraying with Delthamethrin in the living rooms
15949410|NCT03268993|Dietary Supplement|Avmacol|Avmacol is a dietary supplement available over the counter
15949411|NCT03268980|Other|Questionnaire Hospital Staff group|One-page questionnaire with 15 questions about tobacco habits
15949412|NCT03268980|Other|Questionnaire students and patients group|One-page questionnaire with 17 questions about tobacco habits
15949413|NCT03268967|Behavioral|Structured admission procedure|A structured ICU admission was inspired by principles of Crisis Resource Management and simulation training of ICU staff members. The Principles of Crisis Resource Management consisted of a treatment manual, a learning video, clear precise communication tool based on Identification-Situation-Background-Analysis-Recommendations (ISBAR) and Closed loop, actions cards, and ABCDE-evaluation of the patient including debriefing, and training in the simulation environment.
15949414|NCT03268954|Drug|Azacitidine|Azacitidine intravenous or subcutaneous formulation.
15949415|NCT03268954|Drug|Pevonedistat|Pevonedistat intravenous infusion.
15949416|NCT03268941|Drug|TAK-906 Maleate|TAK-906 Maleate Capsules
15949417|NCT03268941|Drug|Metaclopramide|Metaclopramide Tablets
15949418|NCT03268941|Drug|TAK-906 Maleate Placebo|TAK-906 placebo-matching Capsules
15949419|NCT03268928|Behavioral|Story Starters Intervention|Shared reading intervention
15949420|NCT03268928|Behavioral|Wait-list Control|Wait-list control
15949421|NCT03268915|Diagnostic Test|3 minutes sit-to-stand test|3 minutes sit-to-stand test, 1 minute sit-to-stand test, 6 minutes walk test will be performed 2 times for each patients 3 minutes sit-to-stand test with oxygen uptake measurement will be performed one time for each patient
15949422|NCT03268902|Drug|Azithromycin Oral Liquid Product|Azithromycin 20 mg/kg administered by study personnel at 6, 9, 12 and 15 months
15949423|NCT03268902|Drug|Nitazoxanide Oral Suspension|Nitazoxanide 100 mg given twice daily for 3 days at 12 and 15 months
15949424|NCT03268902|Dietary Supplement|Nicotinamide|"Mothers in the nicotinamide arm will be given nicotinamide 250 mg daily from delivery through 6 months post-partum in capsule form.
~Children in the nicotinamide arm will be given 100 mg/d in powder form between 6 and 18 months of age"
15949425|NCT03268902|Drug|Placebos|"Contain inert excipients only. Azithromycin placebo 20 mg/kg administered by study personnel at 6, 9, 12 and 15 months. Nitazoxanide placebo 100 mg given twice daily for 3 days at 12 and 15 months.
~Mothers in the nicotinamide placebo arm will be given placebo 250 mg daily from delivery through 6 months post-partum in capsule form.
~Children in the nicotinamide placebo arm will be given 100 mg/d of placebo in powder form between 6 and 18 months of age"
15949426|NCT03268889|Drug|Chidamide|Chidamide is given to the patients in this study along with CHOP regimen, to access the efficacy and safety in this cohort of PTCL patients. The dosage of the above regimen is as follows: Chidamide, 30mg,po,biw; Cyclophosphamide 750mg/m2, ivgtt, d1; Epirubicin 70mg/ m2, ivgtt, d1; Vincristine 3mg/ m2, ivgtt, d1; Prednisone 100mg/ m2, po, d1-5.
15949427|NCT03268863|Device|Virtual Reality|Google Cardboard virtual reality headset
15949428|NCT03268863|Other|Cold Pressor|A cold ice water bath for use in pain/discomfort simulation
15949429|NCT03268850|Other|Standard of Care|All patients participating in the study will continue to receive usual care. Kidney transplant (KT) candidates are advised that live donor kidney transplantation (LDKT) is their best treatment option and are encouraged to initiate living donor (LD) discussions with family members and friends.
15949430|NCT03268850|Behavioral|Wage Reimbursement A|"Enrolled KT candidates will be informed that, in addition to the National Living Donor Assistance Center (NLDAC) program, their LD may be eligible to receive reimbursement for wages lost during the donation recovery period - up to a certain amount, based on randomization. They will be given information describing the LW program, eligibility criteria, and application process to share with potential LDs. At the time of study enrollment, KT candidates will consent to the LD nurse coordinator informing all of their potential LDs about the study and the potential for reimbursement of LD lost wages.
~Reimbursement will occur for those LDs who file an application, provide the required documentation, and meet eligibility criteria."
15949492|NCT03268369|Radiation|PET scan [18F]FDG|exam performed after iv injection of 200 MBq [18F]FDG
15949493|NCT03268343|Drug|Cytisine|Cytisine 1.5 mg Film-Coated Tablets
15949494|NCT03268304|Other|VR-based training including AO and MI|Virtual Reality-based training intervention including Action Observation and Motor Imagery using the YouGrabber® training device
15949431|NCT03268850|Behavioral|Wage Reimbursement B|"Enrolled KT candidates will be informed that, in addition to the National Living Donor Assistance Center (NLDAC) program, their LD may be eligible to receive reimbursement for wages lost during the donation recovery period - up to a certain amount (different from LW-A), based on randomization. They will be given information describing the LW program, eligibility criteria, and application process to share with potential LDs. At the time of study enrollment, KT candidates will consent to the LD nurse coordinator informing all of their potential LDs about the study and the potential for reimbursement of LD lost wages.
~Reimbursement will occur for those LDs who file an application, provide the required documentation, and meet eligibility criteria."
15949432|NCT03268837|Device|Programmed Intermittent Bolus|The Smith CADD(R)-Solis Ambulatory Infusion Pump will be used to provide programmed intermittent bolus for the interscalene block.
15949433|NCT03268837|Device|Continuous Infusion|The Smith CADD(R)-Solis Ambulatory Infusion Pump will be used to provide continuous infusion for the interscalene block.
15949434|NCT03268824|Device|Electroencephalogram (EEG)|Intracerebral electroencephalogram (EEG) will be analysed to quantify the intensity of epileptic discharge (the epileptogenicity index) on each electrode contact (only for children with focal epilepsy).
15949435|NCT03268824|Device|Diffusion Tensor imaging|We will perform Diffusion Tensor imaging in order to relate tractography measures to seizure recordings. Loss of connectivity (or disconnections) will be determined with diffusion tractography for each brain region. Then we will correlate the degree of epileptogenicity with the number of disconnections.
15949436|NCT03268824|Other|Language assessment|The language assessment will be adapted to the age of the child, with a predominant neuropsychological component.
15949437|NCT03268811|Drug|Teduglutide|Teduglutide 0.05 mg/kg SC injection will be administered once daily into 1 of the 4 quadrants of the abdomen or either thigh or arm.
15949438|NCT03268811|Device|Syringe|Teduglutide will be administered using a syringe. Syringe is approved for use in Japan by pharmaceuticals and medical devices agency (PMDA).
15949439|NCT03268811|Device|Needle|Teduglutide will be administered using needle. Needle is approved for use in Japan by PMDA.
15949440|NCT03268811|Device|Vial Adapter for Device|Vial adapter for device is approved for use in Japan by PMDA.
15949441|NCT03268798|Device|Unilateral wrist extension training|Participants will join a five-week training protocol with 3 sessions per week. During each session, 5 sets 5 maximal wrist extension training will be performed on participants less affected side.
15949442|NCT03268785|Diagnostic Test|Intraoperative identification method|After needle pucture of suspicious nodes, Diff-quik staining was used to distinct lymph nodes and parathyroid glands. PTH test assay was used for parathyroid identification. Postoperative HE staining were applied as golden standard.
15949443|NCT03268772|Drug|PLD and IFO|PLD 30 mg/m2, d1, plus IFO 1.8 g/m2, d1-5
15949444|NCT03268759|Other|fMRI|Observation of neural markers of reward processing
15949445|NCT03268746|Device|AcrySof IQ PanOptix Multifocal IOL|AcrySof IQ PanOptix Multifocal IOL Model TFNT00 for near, intermediate, and distance vision intended for long-term use over the lifetime of the cataract subject
15949446|NCT03268733|Drug|Folic Acid|Tablet 5 mg
15949447|NCT03268720|Other|FODMAP low diet|2 week FODMAP low diet
15949448|NCT03268720|Other|gluten-free diet|2 week gluten-free diet
15949449|NCT03268707|Device|Telemetric smartphone application|Structured follow up with a telemetric smartphone application
15949450|NCT03268707|Other|Conventional follow up|Conventional follow up at physician practice
15949451|NCT03268694|Behavioral|Working Memory Task|"Sternberg Task Items, which can be visually presented alphabets, shapes or numbers or sound tones presented through speakers, will be presented to the participant. The participant will need to maintain the presented items in their memory and indicate, when a single probe item is presented, whether the probe item was present in the immediately preceding list by pressing a key on the keyboard.
~N-Back Task Items are presented continuously sequentially and participants are instructed to indicate whether items are repeated n items before by pressing a key on the keyboard. The task is divided into blocks of 0,1,2,3 -back trials based on the 'n'. For example in the 2 - back task, the participant has to indicate if the item presented 2 items before matches the current item. Similar to the previous task, the items can be presented visually or auditorily."
15949452|NCT03268694|Behavioral|Reward Learning Task|Two abstract visual stimuli are presented on the screen and participant is asked to choose one. Unknown to the participant, each stimulus is associated with distinct probabilities of virtual reward such that one stimulus is associated with net gain while the other is associated with net loss. The participant's goal is to maximize the reward. Once the participant identifies the stimulus associated with net gain, the reward probabilities are reversed. This process is repeated 5 times.
15949453|NCT03268694|Behavioral|Facial Emotion Recognition Task|On a given trial, participants will be presented with images of two faces side-by-side. The faces will either match in terms of emotion category (e.g., 2 anger faces) or not (e.g., an anger face and a fear face). Faces presented together will always be of the same gender but different identities. Participants will be asked to determine whether the two faces presented depict the same emotion category.
15949454|NCT03268668|Other|Collection of thrombus that is responsible for stroke and blood sample|"A blood sample (venous or arterial) of 10 ml will be made, on ethylene Diamine Tetra-Acetic (EDTA) tube (5 ml) and citrate (5 ml).Thrombus resulting from thrombectomy will be collected at the end of the procedure. The samples will be transferred to a biobank. Treatment efficacy, etiology and prognosis of patients will be assessed using the following criteria :
~A) TOAST score (etiology) B) TICI score (status of final recanalization) C) Extravasation of contrast agent on post-intervention CT (rupture of the blood-brain barrier :yes/no) D) Symptomatic haemorrhagic transformation corresponding to an increase > 4 of the NIHSS score due to a haemorrhagic transformation identified on brain imaging 24 hours after stroke E) Decreased NIHSS score by 8 points or NIHSS score = 0 24 hours after stroke (improved neurological status: yes/no) F) Modified RANKIN score (mRS) measured at 3 months evaluating neurological prognosis"
15949455|NCT03268655|Dietary Supplement|Ginger extract|2000 mg ginger extract daily for 6 weeks, plus 6 weeks washout
15949456|NCT03268655|Other|Placebo|2000 mg ginger extract daily for 6 weeks, plus 6 weeks washout
15949457|NCT03268629|Behavioral|Mindfulness-Based Joyful Sleep|"The proposed Mindfulness-Based Joyful Sleep program will be conducted weekly, 2 hours per session, 8 sessions, group-based program in mindfulness."
15983848|NCT03008720|Device|Functional electrical stimulation (FES)|
15949459|NCT03268616|Device|inspiratory threshold load device and NPPV|"before experiment ,every subject use a flanged mouthpiece attached to a manually operated occlusion valve in order to measure maximal inspiratory pressure (MIP)at functional residual capacity .
~healthy subjects:increase the pressure in a water-sealed inspiratory threshold loading device in order to increase the neural respiratory drive.
~COPD patients:increase the pressure in a non-invasive positive pressure ventilation in order to decrease the neural respiratory drive"
15949460|NCT03268603|Drug|Autologous Adipose-derived Mesenchymal Stromal Cells|The investigational product consists of autologous adipose-derived Mesenchymal Stromal Cells (MSCs), suspended in 5-10 mL Lactated Ringer's. The MSC are provided in a sterile syringe labelled with appropriate patient and product identifiers ready for intrathecal injection.
15949461|NCT03268590|Drug|Oxygen|Persons will undergo MRI, EEG, and complete computerized cognitive testing in baseline room air. Persons will then breathe 100% pure oxygen and undergo MRI, EEG, and complete computerized cognitive testing. Persons will serve as their own controls.
15949462|NCT03268577|Other|Internet-Based Intervention|Complete ASA24
15949463|NCT03268577|Other|Internet-Based Intervention|Complete ACT24 reporting
15949464|NCT03268577|Device|Monitoring Device|Wear accelerometer and inclinometer physical activity monitors
15949465|NCT03268577|Other|Questionnaire Administration|Ancillary studies
15949466|NCT03268564|Behavioral|HIVST-online promotion|"Health promotion for those who are not users of previous HIVST-online services (i.e. not re-testers):
~Viewing a promotion video and a demonstration video
~Brief motivational interviewing through telephone
~Visiting the HIVST-online webpage
~Receiving a free self-testing kit and follow-up reminders
~Health promotion for re-testers:
~Viewing a promotion video and a demonstration video
~Visiting the HIVST-online webpage
~Receiving a free self-testing kit and follow-up reminders"
15949467|NCT03268525|Drug|Marcaine 0.5 % Injectable Solution|Local infiltration by Marcaine 0.5% Injectable Solution prior to incision
15949468|NCT03268525|Drug|Sodium Chloride 0.9%|Local infiltration by Sodium Chloride 0.9% prior to incision
15949469|NCT03268512|Other|L-PRF|"Platelet concentrates are produced from a small peripheral blood sample, which is immediately centrifuged without any anticoagulant. Coagulation starts during the centrifugation, and three layers are obtained: red blood corpuscles (RBCs) at the bottom of the tube, platelet-poor plasma (PPP) on the top and an intermediate layer called buffy coat where most platelets and leucocytes are concentrated. L-PRF has potential advantages, namely: it creates a bioactive construct that stimulates the local environment for differentiation and proliferation of stem and progenitor cells and it acts as an immune regulation node with inflammation control abilities, such as slow continuous release of growth factors over a period of 7-14 days."
15949470|NCT03268512|Other|A-PRF|"Platelet concentrates are produced from a small peripheral blood sample, which is immediately centrifuged without any anticoagulant. Coagulation starts during the centrifugation, and three layers are obtained: red blood corpuscles (RBCs) at the bottom of the tube, platelet-poor plasma (PPP) on the top and an intermediate layer called buffy coat where most platelets and leucocytes are concentrated. L-PRF has potential advantages, namely: it creates a bioactive construct that stimulates the local environment for differentiation and proliferation of stem and progenitor cells and it acts as an immune regulation node with inflammation control abilities, such as slow continuous release of growth factors over a period of 7-14 days."
15949471|NCT03268499|Drug|Cisplatin|The procedure of TACE is the same irrespective of which regimen is used.
15949472|NCT03268473|Other|Non-surgical periodontal therapy|Experimental: Non-surgical periodontal therapy (scaling and root planing) and supportive periodontal therapy
15949473|NCT03268473|Other|Delayed non-surgical periodontal therapy|Delayed non-surgical periodontal therapy (scaling and root planing) after the 3 month visit
15949474|NCT03268460|Diagnostic Test|Arterial blood gases|blood PH, HCO3
15949475|NCT03268460|Diagnostic Test|Blood anion gap|(Na+) - (Cl- + HCO3-)
15949476|NCT03268460|Diagnostic Test|serum electrolytes|Na+ , K+ , Cl- and calcium
15949477|NCT03268460|Diagnostic Test|renal function test|blood urea and serum creatinine
15949478|NCT03268460|Diagnostic Test|urine analysis|urine PH, specific gravity, aminoaciduria, glycosuria, phospaturia and 24 hr urine calcium
15949479|NCT03268447|Dietary Supplement|Lactobacillus plantarum P8|This project aims to study the benefits of probiotics namely Lactobacillus plantarum P8 for brain health benefits primarily to alleviate stress, among adults in Malaysia aged from 18-60 years.
15949480|NCT03268447|Dietary Supplement|Placebo|This project aims to study the benefits of probiotics namely Lactobacillus plantarum P8 for brain health benefits primarily to alleviate stress, among adults in Malaysia aged from 18-60 years.
15949481|NCT03268434|Behavioral|D-MCT|Metacognitive Training for Depression (D-MCT), 8 sessions (60min); once a week over a period of 8 weeks. Metacognitive Training for depression (D-MCT) is a low-threshold, easy to administer group intervention. It aims at the reduction of depressive symptoms by changing cognitive biases; not only biases targeted in cognitive behavioral therapy but also those identified by basic research.
15949482|NCT03268434|Behavioral|Cognitive remediation|A computerized cognitive remediation program that covers several cognitive domains, such as attention, visuomotor skills, and Memory. The difficulty level adapts automatically to the performance level of each patient. At the end of each session, the patient receives individual feedback on his or her performance; 8 sessions (60min), once a week over a period of 8 weeks
15949483|NCT03268421|Behavioral|Fibromyalgia Integrative Training for Teens|This intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols.
15949484|NCT03268421|Behavioral|Cognitive Behavioral Therapy|This intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols.
15949485|NCT03268421|Behavioral|Graded Aerobic Exercise|This intervention will consist of 16 in-person group-based sessions held twice per week over 8 weeks. Sessions last 90 minutes and will be led jointly by a psychologist/therapist and exercise trainer using manualized protocols.
15949486|NCT03268408|Behavioral|Baby Newsletter|eight newsletters sent home to newborns' parents with advices and recommendations on child care and development
15949487|NCT03268395|Diagnostic Test|Arterial Blood Gas and Transcutaneous CO2 Monitor|Each patient will receive both an arterial blood gas and a transcutaneous CO2 monitor test.
15949496|NCT03268291|Behavioral|"Communicational program Trust"|"The developed program is based on the experience of international research studies and includes the following sections:
~daily seminars with patients going to be discharged about the benefits of adherence to therapy; distribution of printed materials; service for the regular informing of the patients which is motivating to remain adherence to medications by automated contact management systems (SMS, e-mail), as well as calls from contact center operators; questioning of participants of the program for general adherence to therapy, reasons for refusal, change of therapy / drug, complaints and other. The questioning is carried out through telephone interviewing by contact center operators and automatic collection of electronic forms through aggregator services."
15949497|NCT03268278|Drug|Buprenorphine|Buprenorphine plus local anesthetic
15949498|NCT03268278|Drug|Sterile saline|Placebo 1,8 ml
15949499|NCT03268278|Drug|lidocaine, epinephrine (Local anesthetic)|2% lidocaine 1:100,000 epinephrine
15949500|NCT03268239|Device|Additional MRI sequences|"Due to the participation in the study, the following sequences are added to the imaging protocol:
~3D T1 GRE after injection (Gradient-Recalled Echo)
~3D T1 TSE before injection (Turbo Spin Echo)
~3D fGATIR PSIR after injection (fast Gray Matter Acquisition T1 Inversion Recovery Phase-Sensitive Inversion Recovery)
~Sequences will be performed in a random order to avoid the bias induced by different time intervals between injection and acquisition."
15949501|NCT03268226|Drug|Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium|An inhaled dose of CHF 5993 pMDI 100+6+12.5 μg twice a day (Total daily dose: BDP 400 μg / FF 24 μg / GB 50 μg)
15949502|NCT03268213|Biological|Fecal Microbial Transplantation|"Fecal microbial transplant is offered as treatment option to eligible patients. Donors selected by the patients will be screened by questionnaire and by blood and stool tests for potential transmissible pathogens.
~The stool filtrate will be administered in the ileum and/or cecum via colonoscopy"
15949503|NCT03268200|Other|segmental reexamination|segmental reexamination during colonoscopy
15949504|NCT03268187|Device|Biofeedback|The skin conductance of the patient is measured and fed back to the patient via screen.
15949505|NCT03268187|Behavioral|Self-Alert Training|Self-Alert Training
15949506|NCT03268187|Behavioral|Relaxation Training|Relaxation Training
15949507|NCT03268174|Other|AO+Mist|"Subjects receive 2 bottles of product at the Baseline visit for left and right side application. One bottle will contain Placebo only, the other bottle will contain AO+Mist.
~Label on each bottle will indicate the arm the product is to be applied to. Subjects will be instructed in the use of the spray bottle and asked to self-administer the Test Product as follows:
~LEFT arm where skin is affected: 4 pumps of Spray which is labeled accordingly must be applied twice-a-day to the area on the arm affected by AD- once in the morning and once in the evening for 30 days.
~RIGHT arm where skin is affected: 4pumps of Spray which is labeled accordingly must be applied twice-a-day to the area on the arm affected by AD- once in the morning and once in the evening for 30 days."
15949508|NCT03268174|Other|Placebo|"Subjects receive 2 bottles of product at the Baseline visit for left and right side application. One bottle will contain Placebo only, the other bottle will contain AO+Mist.
~Label on each bottle will indicate the arm the product is to be applied to. Subjects will be instructed in the use of the spray bottle and asked to self-administer the Test Product as follows:
~LEFT arm where skin is affected: 4 pumps of Spray which is labeled accordingly must be applied twice-a-day to the area on the arm affected by AD- once in the morning and once in the evening for 30 days.
~RIGHT arm where skin is affected: 4pumps of Spray which is labeled accordingly must be applied twice-a-day to the area on the arm affected by AD- once in the morning and once in the evening for 30 days."
15949509|NCT03268161|Diagnostic Test|Mutational analysis of clonal B cells|"Mutational analysis based on medullary or blood samples stored in a bio-bank during routine lymphocyte phenotyping.
~Mutations affecting MYD88 (MYD88 L265P mutation), CXCR4 (Whim-like CXCR4 mutation) loci are sought."
15949510|NCT03268148|Device|LaserPen|low level laser is used before heel-lancing for newborn screening
15949511|NCT03268135|Diagnostic Test|measurement of RNAs|
15949512|NCT03268122|Other|Standard Contact Isolation|With regards to MRSA and VRE, the wearing of gowns and gloves will be required for all staff entering a patient room if the patent has an infection or colonization with MRSA or VRE or a recent history (within 90 days) of either
15949513|NCT03268122|Other|Targeted Contact Isolation|"With regards to MRSA and VRE, the wearing of gowns and gloves will be required for all staff entering a patient room if the patient has an active, highly-transmissible infection with MRSA and/or VRE.
~A highly-transmissible infection is defined as one with uncontained secretions or excretions (diarrhea, vomiting, or open draining wounds) or pneumonia."
15949514|NCT03268109|Other|assessment of cognitive impairment|Measure of Global Deficit Score
15949515|NCT03268096|Device|Cerebral MRI and Optical Coherence Tomography|Clinical and paraclinical assessment (cerebral MRI and Optical Coherence Tomography) will be carried out on the same day. Paraclinical evaluation consists in the realization of additional MRI sequences in order to obtain more precise information on brain lesions (unconventional parameters). An optical coherence tomography will also be performed for both eyes to describe the thickness of the different layers of the retina.
15949519|NCT03268070|Device|Repetitive TMS over contralateral premotor cortex.|Repetitive Transcranial magnetic stimulation (rTMS) will be applied over contralateral premotor cortex during motor training. TMS uses magnetism to excite neurons near the surface of the brain. Frequency of rTMS: 0.1 Hz; time of rTMS: 50 milliseconds before the onset of movement-related electromyography (EMG); device: Super Rapid 2 Transcranial Magnetic Stimulator.
15949520|NCT03268070|Device|Repetitive TMS over ipsilateral premotor cortex.|Repetitive Transcranial magnetic stimulation (rTMS) will be applied over ipsilateral premotor cortex during motor training. TMS uses magnetism to excite neurons near the surface of the brain. Frequency of rTMS: 0.1 Hz; time of rTMS: 50 milliseconds before the onset of movement-related electromyography (EMG); device: Super Rapid 2 Transcranial Magnetic Stimulator.
15949551|NCT03267875|Procedure|Blood Test|draw out 2 blood tubes from a patient
15949625|NCT03267368|Behavioral|Comprehensive Care Program|Pulmonary rehabilitation and smoking cessation
15949521|NCT03268070|Device|Repetitive TMS over contralateral primary motor cortex.|Repetitive Transcranial magnetic stimulation (rTMS) will be applied over contralateral primary motor cortex during motor training. TMS uses magnetism to excite neurons near the surface of the brain.Frequency of rTMS: 0.1 Hz; time of rTMS: 50 milliseconds before the onset of movement-related electromyography (EMG); device: Super Rapid 2 Transcranial Magnetic Stimulator.
15949522|NCT03268070|Device|Sham Repetitive TMS over contralateral premotor cortex.|Sham rTMS will be applied over contralateral premotor cortex. TMS uses magnetism to excite neurons near the surface of the brain. Frequency of rTMS: 0.1 Hz; time of rTMS: 50 milliseconds before the onset of movement-related electromyography (EMG); device: Super Rapid 2 Transcranial Magnetic Stimulator.
15949523|NCT03268070|Device|Single TMS over extensor carpi ulnaris spot of motor cortex|Single-pulse TMS will be applied over the extensor carpi ulnaris (ECU) hotspot of primary motor cortex (M1) during motor training.TMS uses magnetism to excite neurons near the surface of the brain. TMS pulses will be applied at different strengths (30%-80% maximum stimulator output) and record subsequent activity of the ECU muscle using electromyography (EMG).
15949524|NCT03268057|Drug|VX15/2503 + avelumab|Dose escalation will begin at 5 mg/kg of VX15/2503 and will increase up to 20 mg/kg with a constant dose of avelumab at 10 mg/kg. A recommended phase II dose of VX15/2503 will be determined and then utilized in the expansion phase with 10 mg/kg of avelumab.
15949525|NCT03268044|Other|Hospital admission and surgery|Hospital admission and noncardiac surgery
15949526|NCT03268031|Diagnostic Test|Visual field and OCT tests|Visual field test and OCT are commonly used essential tests to make accurate diagnosis of glaucoma. Algorithms to classify Visual field and OCT tests would both be developed and verified.
15949527|NCT03268018|Device|Laser induced pressure wave calcium modification|A calcium atherectomy and modification solution in patients with balloon resistant calcified lesions in infrainguinal disease. The intent is to both debulk and modify the vessel to restore blood flow, improve vessel compliance and drive better outcomes
15949528|NCT03268005|Drug|Faster-acting insulin aspart|Faster aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.
15949529|NCT03268005|Drug|Insulin aspart|Insulin aspart given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.
15949530|NCT03268005|Drug|Insulin degludec|Insulin degludec given subcutaneously (s.c., under the skin) once a day for 16 weeks. Dose individually adjusted.
15949531|NCT03268005|Drug|Metformin|Only participants who took metformin before the study should take metformin tablets, same dose as before the study
15949532|NCT03267992|Behavioral|COPD Co-Pilot AIR App|App. For COPD symptoms after Coil procedure
15949533|NCT03267979|Other|Video-pupillometer|Video-pupillometer will be performed. In this study data will be collected and analyzed.
15949534|NCT03267979|Other|Electrocardiogram|Electrocardiogram will be performed. In this study data will be collected and analyzed.
15949535|NCT03267966|Diagnostic Test|Leeds Pathology Protocol (LEEPP)|LEEPP includes: 1) multicolor inking; 2) axial slicing; 3) circumferential margin; 4) 1-mm clearance
15949536|NCT03267953|Behavioral|My Health CheckUp Online Stress Management Program|Self-contained, web-based, stress management program developed by team of health care professionals, designed to encourage patients to learn evidence-based cognitive and behavioural strategies to effectively manage stress. Health risk appraisals include evidence-based recommendations to address risks. Stress management modules include education about the impact of stress, self-monitoring through a stress diary, and using four key strategies: physical activity, deep breathing and relaxation, problem-solving/addressing negative thoughts, and sleep hygiene. Through the modules, patients will learn new stress management strategies and have an opportunity to practice these, track their progress, and obtain feedback via the website. To facilitate self-monitoring of stress levels and tracking of strategies such as physical activity, tracking tools can be used on mobile devices.
15949537|NCT03267953|Behavioral|Lay telephone coaching|The goal of telephone coaching will be to provide brief encouragement on how to use the modules; however, no formal therapy will be provided. Sessions will range between 10-15 minutes. Each coach session will follow the process outlined by the GROW model, which stands for Goal, Reality, Options/Obstacles, and Will/Way forward. The sessions will start with the coach and participant agreeing on the topics for discussion and desired outcomes (goal). Then, coaches will explore the use of the intervention over the previous week, guide participants through the modules, identify barriers to using these modules, offer advice to overcome these barriers, and provide positive reinforcement. The development of an action plan for the following week will conclude each session. The short Perceived Stress Scale will be used at the end of each session to monitor progress. A script will guide the lay coach through each call.
15949538|NCT03267953|Behavioral|Motivational interviewing (telephone)|Sessions will range from 30 to 45 minutes. The goal of MI is to strengthen patients' motivation and confidence for adopting the stress management strategies suggested. The MI practitioner's interventions are based on the four processes of MI: Engaging, Focusing, Evoking, and Planning.
15949539|NCT03267940|Drug|PEGPH20|PEGPH20 will be administered as per the schedule specified in the respective arms.
15949540|NCT03267940|Drug|CIS|CIS will be administered as per the schedule specified in the respective arms.
15949541|NCT03267940|Drug|GEM|GEM will be administered as per the schedule specified in the respective arms.
15949542|NCT03267940|Drug|Atezolizumab|Atezolizumab will be administered as per the schedule specified in the respective arms.
15949543|NCT03267927|Device|Rapid palatal expansion|Fixation of rapid palatal expansion from day 0 to day 60
15949544|NCT03267927|Device|MGA™ system|Use of a mandibular advancement Appliance during the night from day 60 to day 180 (end of treatment from day 120 if Angle Class I is obtained)
15949545|NCT03267927|Device|Yoobreath™ system|Use of a device allowing sleep in a semi-seated position during the night from day 15 to day 180 (end of treatment from day 120 if Angle Class I is obtained)
15949546|NCT03267914|Other|Tray|Control intervention Patients will use the custom-made tray to apply the fluoride locally to the teeth and wear for 5 minutes each day.
15949547|NCT03267914|Other|Brush|Patients will brush with the fluoride for 2 minutes each day.
15949548|NCT03267901|Other|food|45 g of walnut / iso-caloric white bread
15949549|NCT03267888|Biological|Pembrolizumab|Given 200 mg/kg IV.
15949550|NCT03267888|Radiation|Radiation Therapy|Patients will receive radiotherapy (8 Gy/1 fx) to an extra-osseous site and/or any bony site containing myeloma deposit.
15949552|NCT03267862|Other|there was no intervention|patients were observed during routine care on separate times when their eye pressure was different on one day from another.
15949553|NCT03267849|Other|wearing swimming goggles or having laser suturelysis|Two images will be compared in each subject at two different eye pressures with the higher pressure having been produced by the interventions
15949554|NCT03267836|Drug|Avelumab|-10mg/kg IV
15949555|NCT03267836|Radiation|Proton Therapy|-Proton therapy will start concurrently with the first dose of avelumab (up to 3 days before or after is permissible) and will be administered once daily during weekdays (Monday through Friday).
15949556|NCT03267836|Procedure|Surgery|-Standard of care
15949557|NCT03267823|Diagnostic Test|International Normal Ratio (INR)|Blood test for INR using laboratory and point of care methods
15949558|NCT03267810|Device|TENS|TENS 7000
15949559|NCT03267810|Other|Sham TENS|Inactive electrodes
15949560|NCT03267797|Other|Peripheral Blood Monouclear Cell|Blood samples (20 mL) were taken from individual patients at the time of ovulation induction. Then PBMC were isolated and cultured (20-30 million cells) 48 hour at the presence of hCG (10IU/ml daily). Afterward,15-20 million PBMCs in 500 microlitres PBS were injected into the uterine cavity two days before embryo transfer (ET) using ET catheter.
15949561|NCT03267797|Other|Phosphate Baffer Saline|Only 500 microlitres PBS will be injected into the uterine cavity, instead of PBMCs, two days before embryo transfer (ET) using ET catheter.
15949562|NCT03267784|Biological|allo-APZ2-DFU|Suspension of ABCB5-positive mesenchymal stem cells
15949563|NCT03267771|Drug|Progesterone Suppositories Vaginal|progesterone vaginal suppository
15949564|NCT03267771|Drug|Dydrogesterone Oral Tablet|oral progesterone drug
15949565|NCT03267771|Device|doppler ultrasound|pulsed doppler ultrasound
15949566|NCT03267758|Dietary Supplement|Goodbelly first|Consumption of 1 serving of Goodbelly probiotic daily for 6 weeks. This is followed by 6 weeks of placebo.
15949567|NCT03267758|Dietary Supplement|Placebo first|Consumption of 1 serving of probiotic placebo daily for 6 weeks. of 1 serving of Goodbelly probiotic daily for 6 weeks.
15949568|NCT03267745|Dietary Supplement|Amino Acid|23.7 g amino acid 3 times daily for 28 days
15949569|NCT03267745|Device|Breg Brace single-leg immobilization|7 days of single leg immobilization; randomized to leg; knee brace will be worn in a fixed flexion position at 140°.
15949570|NCT03267745|Other|Placebo|Excipient-matched placebo 3 times daily for 28 days
15949571|NCT03267732|Biological|Pegilodecakin|Pegilodecakin Alone
15949572|NCT03267719|Device|laser therapy|Transvaginal erbium-laser treatment
15949573|NCT03267706|Other|Palliative Care Comprehensive Tool|Clinicians assigned to the newly developed Palliative Care Comprehensive Tool will be trained during a 1 hour period on the application of the tool; Including rationale for tool development, objective of the tool and demonstration of the tool in action
15949574|NCT03267693|Diagnostic Test|Gastric and oropharyngeal PH|measurement of gastric and oropharyngeal PH and their relation to respiratory and gastrointestinal complication in mechanically ventilated patients
15949575|NCT03267680|Drug|Cyclophosphamide|Given IV
15949576|NCT03267680|Drug|Indomethacin|Given PO
15949577|NCT03267680|Biological|IRX-2|Given via submucosal injection or SC
15949578|NCT03267680|Other|Laboratory Biomarker Analysis|Correlative studies
15949579|NCT03267680|Dietary Supplement|Multivitamin|Given zinc-containing multivitamin PO
15949580|NCT03267680|Drug|Omeprazole|Given PO
15949581|NCT03267680|Other|Placebo|Given via submucosal injections or SC
15949582|NCT03267680|Procedure|Therapeutic Conventional Surgery|Undergo surgical resection
15949583|NCT03267667|Diagnostic Test|2D Echocardiography and cardiac MRI|imaging of right ventricle by both modalities to assess right ventricle function accurately
15949584|NCT03267654|Drug|gefitinib combined with chemotherapy|"Gefitinib 250mg, p.o., q.d., continuous regimens on an empty stomach or after meal for 2 hours until disease progression, intolerable toxicity or patient withdraw ICF.
~Pemetrexed (500mg/m²day 1 intravenously) plus carboplatin (AUC=5,day 1,intravenously) every 21 days. Every 3 weeks is a chemotherapy cycle, and 4 chemotherapy cycles is maximum limit."
15949585|NCT03267654|Drug|gefitinib combined with apatinib|"gefitinib 250mg, p.o., q.d., continuous regimens on an empty stomach or after meal for 2 hours.
~Apatinib 250mg, p.o., q.d. per 21 days. until disease progression, intolerable toxicity, patient withdraw ICF or death."
15949586|NCT03267654|Drug|gefitinib single agent|Patients received Gefitinib 250mg q.d. orally until disease progression, intolerable toxicity or death.
15949587|NCT03267628|Procedure|Intrathecal morphine as well as local anaesthetic in Blocks|A Quadratus lumborum type 2 block will be performed under ultrasound with 25 ml 0.375% ropivacaine deposited posterior to the quadratus lumborum muscle. 150mcg morphine will be added to the spinal anaesthetic.
15949588|NCT03267628|Procedure|Intrathecal morphine as well as saline in Block|150mcg morphine will be added to the spinal anaesthetic. 25 ml saline will be used on each side during a quadratus lumborum type 2 block.
15949589|NCT03267628|Procedure|Saline intrathecal as well as saline in Blocks|0.3 ml saline will be added to the spinal anaesthetic. 25 ml saline will be used on each side during a quadratus lumborum type 2 block.
15949590|NCT03267628|Procedure|Saline intrathecal as well as local anaesthetic in Blocks|0.3 ml saline will be added to the spinal anaesthetic. A Quadratus lumborum type 2 block will be performed under ultrasound with 25 ml 0.375% ropivacaine deposited posterior to the quadratus lumborum muscle.
15949591|NCT03267602|Device|CPAP|"If following patients are suffering from sleep apnea and agree to receive treatment,
~older than 18 years, AHI> 15 and present obvious symptoms or
~less than 18 years, AHI still> 5 after tonsillectomy and present obvious symptoms.
~Investigators will process CPAP treatment for 3 months, and do neuropsychological assessment and sleep examination after treatment for 6 months."
15949592|NCT03267589|Drug|Durvalumab, Tremelilumab, MEDI 9447, MEDI 0562|Three different combination are being tested. Each cohort has different combination
15949593|NCT03267576|Drug|Canagliflozin 300 mg|Participants will receive canagliflozin 300 mg oral tablet once-daily for 28 days.
15949594|NCT03267576|Drug|Sitagliptin 100 mg|Participants will receive sitagliptin 100 mg oral tablet once-daily for 28 days.
15949595|NCT03267576|Drug|Metformin|Participants will receive metformin at a stable dose of >= 1500 mg/day throughout the study including the washout period between each intervention.
15949596|NCT03267563|Behavioral|EIAU|Enhanced implementation as usual consists of initial training and problem-solving plus planning for sustainment,
15949597|NCT03267563|Behavioral|LICF|"Enhanced implementation plus low intensity will have received initial training and problem-solving plus planning for sustainment and after that every 3 months will receive one clinical and one operational telephone booster meeting."
15949598|NCT03267563|Behavioral|HICF|Enhanced implementation plus high intensity will receive will receive everything that the clinics in LICF receive, but at a higher intensity.
15949599|NCT03267550|Device|SceneRay wireless and remote DBS system|Implement therapeutic programming in patients with network coverage at home
15949600|NCT03267537|Behavioral|Telemedicine CBT-I|Will be administered in a manner similar to the conventional CBT-I arm except that the patient would not be required to make office visits
15949601|NCT03267537|Behavioral|Conventional office-based CBT-I|Conventional office-based CBT-I
15949602|NCT03267524|Behavioral|Exercise Intervention|Receive Walking for Recovery from Surgery prehabilitation intervention
15949603|NCT03267524|Other|Quality-of-Life Assessment|Ancillary studies
15949604|NCT03267524|Other|Survey Administration|Ancillary studies
15949605|NCT03267511|Drug|5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica|Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 0.5% spherical silica and brush twice daily (morning and evening) for one timed minute (in their usual manner).
15949606|NCT03267511|Drug|5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP|Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 1% spherical silica and 5% STP and brush twice daily (morning and evening) for one timed minute (in their usual manner).
15949607|NCT03267511|Drug|5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica|Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2542% NaF dentifrice with 6% abrasive silica and brush twice daily (morning and evening) for one timed minute (in their usual manner).
15949608|NCT03267511|Drug|5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP|Participants will be instructed to apply a full brush head of their dentifrice containing 5% KNO3 / 0.2543% NaF dentifrice with 16% abrasive silica and 5% STP and brush twice daily (morning and evening) for one timed minute (in their usual manner).
15949609|NCT03267498|Drug|Nivolumab|Dosage 240mg of Nivolumab will be given intravenously over 60 minutes, every 14 days.
15949610|NCT03267498|Drug|Cisplatin|Dosage 40 mg/m2 of cisplatin will be given intravenously over 30-60 minutes, every 7 days.
15949611|NCT03267498|Radiation|Radiation Therapy|2.12 Gy/fraction x 33 fractions of radiation therapy will be given, daily Monday - Friday
15949612|NCT03267485|Device|real time PCR|Real Time PCR is based on the detection of the fluorescence produced by a reporter molecule which increases, as the reaction proceeds. These fluorescent reporter molecules include dyes that bind to the double-stranded DNA or sequence specific probes . Moreover, there is no need for the post PCR processing which saves the resources and the time. .
15949613|NCT03267459|Device|Dynamic contrast-enhanced MRI|Dynamic contrast-enhanced perfusion sequences added to MRI examination performed at the beginning of intra arterial chemotherapy.
15949614|NCT03267446|Device|3D Doppler Ultrasound|3D volumes will be obtained in automatic sweeps using a motorized curved-array transducer while the women held their breath. In order to interpret the data consistently, the settings of power, On Voluson E10; GE Medical Systems)
15949615|NCT03267433|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo HCT
15949616|NCT03267433|Other|Laboratory Biomarker Analysis|Correlative studies
15949617|NCT03267433|Biological|Rituximab|Given IV
15949618|NCT03267420|Diagnostic Test|BpTRU First, Unattended Omron Second|"Visit 1: The participants will have the oscillometric device, BpTRU applied to their arm with the higher blood pressure. This will allow assessment with the commonest used Canadian device, which provides an average after 5 unattended readings. This assessment will be followed by the participant wearing a 24 hour ambulatory blood pressure monitor (ABPM) for 24 hours.
~Visit 2: Upon returning the 24 hour ABPM device, the patient will have their blood pressure measured with an unattended Omron second. The Omron HEM 907XL will be applied to the same arm that the BpTRU was applied to in the first visit. There will be 5 minutes of quiet rest (participant alone) and three readings subsequently while the patient is still alone with the average blood pressure measurement being noted."
15949619|NCT03267420|Diagnostic Test|Unattended Omron First, BpTRU Second|"Visit 1: The participants will have the Omron HEM 907XL will be applied to their arm with the higher blood pressure. There will be 5 minutes of quiet rest (participant alone) and three readings subsequently while the patient is still alone with the average blood pressure measurement being noted.This assessment will be followed by the participant wearing a 24 hour ambulatory blood pressure monitor (ABPM) for 24 hours.
~Visit 2: Upon returning the 24 hour ABPM device, the participants will have the oscillometric device, BpTRU applied to the same arm that the Omron HEM 907 XL was applied to in the first visit. This will allow assessment with the commonest used Canadian device, which provides an average after 5 unattended blood pressure readings."
15949620|NCT03267420|Diagnostic Test|Partially Attended Omron First, Unattended Omron Second|"Visit 1: The participant will have the Omron HEM 907 XL applied to the arm with the higher blood pressure. There will be five minutes of quiet rest (patient alone) and three reading subsequently, but with the nurse entering the room (i.e., partially attended), with the average being noted. This assessment will be followed by the participant wearing a 24 hour ambulatory blood pressure monitor (ABPM) for 24 hours.
~Visit 2: Upon returning 24 hour ABPM device, the participant will have the Omron HEM 907 XL applied to same arm that was used during the first visit. There will be five minutes of quiet rest (patient alone) and three readings subsequently (patient still alone) with the average blood pressure measurement being noted."
15949621|NCT03267407|Other|Preemptive high-dose Fluconazole|Patients with advanced HIV diseases are screened for Cryptococcal Antigen using LFA CrAg tests. Then patients with CrAg positivity and without meningitis are given preemptive high-dose fluconazole to prevent the development of cryptococcal meningitis, which is one of the leading cause of death among immunocompromized patients.
15949622|NCT03267381|Other|Blood draw (before surgery)|Blood will be drawn before surgery
15949623|NCT03267381|Other|Blood draw (every 3 months)|Blood will be drawn every 3 months
15949624|NCT03267381|Other|Blood draw (at diagnosis)|Blood will be drawn at time of diagnosis
15983849|NCT03008720|Device|Sham stimulation|
15949627|NCT03267342|Behavioral|One-on-one financial counseling|Clients will be given access to one-on-one financial counseling, provided by trained peer specialists, initially working under the guidance of the project director. The Consumer Financial Protection Bureau's Your Money, Your Goals: Financial Empowerment Toolkit for Social Services Programs (21) will be used as a reference during counseling sessions, with a view to developing a manual based on clients' existing experiences and coping strategies, such that the desired behavior change is manageable, realistic, and based on real-life possibilities rather than idealized circumstances which may be far from the reality of people's lives. Counseling will in all cases be responsive to clients' particular needs and concerns, rather than following a predetermined sequence.
15949628|NCT03267342|Behavioral|Peer support group|Support groups, facilitated by peer specialists and guided initially by the project director, will be offered for clients interested in specific financial issues such as budgeting, managing benefits, wise spending, planning and saving. The peer support groups will focus on enabling clients to share their own experiences with finances.
15949629|NCT03267342|Behavioral|Supported access to mainstream banking services|Interested clients will be helped to open bank accounts at banks of their choice, and to manage associated tools such as Automatic Teller Machine (ATM) cards and online bill pay. Clients will also be advised regarding use of non-bank financial products such as prepaid cards and check cashers. Representatives from both bank and non-bank providers will be invited to come in and talk with clients about the services they offer, and clients will also be invited to visit the facilities to be guided around the available services.
15949630|NCT03267342|Behavioral|A matched savings account|Clients will have the option of joining a savings club, which will combine group meetings, facilitated by a peer specialist under the initial guidance of the project director, and regular savings deposits towards specified goals. Clients will be offered a limited savings match as an incentive to achieve their savings goal (for example, the savings club will offer a 50% match on any money saved within a specified time period towards a specific goal, up to a maximum of a $100 match).
15949631|NCT03267329|Drug|Duowell®|telmisartan 80mg/rosuvastatin 10mg for ASCVD risk=5%~7.5% or telmisartan 80mg/rosuvastatin 20mg for ASCVD risk≥7.5%
15949632|NCT03267329|Drug|Telmisartan|telmisartan 80mg
15949633|NCT03267316|Biological|CAN04|A fully humanized monoclonal immunoglobulin G1 (IgG1) antibody (hmAb) in aqueous solution administered by i.v. infusion.
15949634|NCT03267316|Drug|Cisplatin|Standard of care treatment
15949635|NCT03267316|Drug|Gemcitabine|Standard of care treatment
15949636|NCT03267316|Drug|Nab-paclitaxel|Standard of care treatment
15949637|NCT03267303|Drug|TS-091 5mg|Orally taken once daily for 3 weeks
15949638|NCT03267303|Drug|TS-091 10mg|Orally taken once daily for 3 weeks
15949639|NCT03267303|Drug|Placebo|Orally taken once daily for 3 weeks
15949640|NCT03267290|Diagnostic Test|Sonazoid- CEUS, CEMRI, CECT|Sonazoid- CEUS+CEMRI in a characterization of HCC, in comparison with CECT+CEMRI.
15949642|NCT03267264|Device|BD Nano™ vs Nucleus|"Subjects will be randomized to
~Nucleus pen needle for the first 15-day period, or current pen needle (BD Nano™) for the second 15-day period or
~subject's current pen needle (BD Nano™) for the first 15-day period, Nucleus pen needle for the second 15-day period"
15949643|NCT03267264|Device|NovoFine® vs Nucleus|"Subjects will be randomized to
~Nucleus pen needle for the first 15-day period, or current pen needle (NovoFine®) for the second 15-day period or
~subject's current pen needle (NovoFine®) for the first 15-day period, Nucleus pen needle for the second 15-day period"
15949644|NCT03267264|Device|NovoTwist®/NovoFine® Plus vs Nucleus|"Subjects will be randomized to
~Nucleus pen needle for the first 15-day period, or current pen needle (NovoTwist®/NovoFine Plus®) for the second 15-day period or
~subject's current pen needle (NovoTwis®t/NovoFine® Plus) for the first 15-day period, Nucleus pen needle for the second 15-day period"
15949645|NCT03267264|Device|Other Commercially Available Pen Needles (Unifine® Pentips®/Mylife Clickfine®) vs Nucleus|"Subjects will be randomized to
~Nucleus pen needle for the first 15-day period, or current pen needle (Other Commercially Available Pen Needles) for the second 15-day period or
~subject's current pen needle (Other Commercially Available Pen Needles) for the first 15-day period, Nucleus pen needle for the second 15-day period"
15949646|NCT03267251|Other|Vacteens Web app for mobile devices|The Web app provides parents of young adolescent girls (ages 11-14) accurate information about HPV Vaccination, and a number of tools to aid informed decision making.
15949647|NCT03267251|Other|Standard Usual and Customary HPV Information - CDC pamphlet|The usual communication about HPV Vaccination in clinics is for parents to be issued the CDC pamphlet on HPV Vaccination.
15949648|NCT03267238|Biological|Fecal Microbial Transplantation|Fecal Microbial Transplantation via will be offered to eligible Crohn's patient
15949649|NCT03267212|Device|Non-invasive ventilation(NIV)|The ventilator will be set in spontaneous mode with a ramp to reach a minimal pressure of 12 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.
15949650|NCT03267212|Device|Sham Non-invasive ventilation(NIV)|The ventilator will be set in spontaneous mode with a ramp to reach a maximal pressure of 5 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.
15949651|NCT03267212|Other|Functional Electrical Stimulation Row Training (FESRT)|FESRT couples volitional arm and electrically controlled leg exercise to allow whole body exercise training
15949652|NCT03267199|Drug|Thrombolytic|Thrombolytic therapy
15949653|NCT03267199|Procedure|Primary PCI|Primary percutaneous coronary intervention
15949654|NCT03267199|Diagnostic Test|Complete blood count|Blood sample for complete blood count
15949655|NCT03267199|Diagnostic Test|Platelet function test|Blood sample for platelet function test
15949656|NCT03267199|Diagnostic Test|ECG|Electrocardiogram
15949657|NCT03267186|Drug|Ibrutinib|Given PO
15949658|NCT03267186|Other|Laboratory Biomarker Analysis|Correlative studies
15949659|NCT03267173|Drug|Chimeric antigen receptor T cell|Evaluate the efficacy and safety of targeted Mesothelin/PSCA/CEA/HER2/MUC1/, EGFRvIII and other chimeric antigen receptor engineered T cell immunotherapy in the treatment of pancreatic cancer.
15949660|NCT03267160|Diagnostic Test|Hemodynamic parameters|Pulse contour cardiac output monitored heart contractility, end-diastolic volume parameters, and lung water parameters.
15949661|NCT03267147|Other|no intervention is given|no intervention is given
15949662|NCT03267121|Drug|Apatinib Mesylate Tablets|500 mg qd.p.o. every day for 21 days as a cycle
15949663|NCT03267121|Drug|Tegafur Gimeracil Oteracil Potassium Capsules|25mg/㎡ bid p.o. every day for 14 days as a cycle
15949664|NCT03267108|Combination Product|INOpulse®|Subjects will be treated by means of an INOpulse® device using an INOpulse® nasal cannula.
15949665|NCT03267108|Combination Product|Placebo|Subjects will be treated by means of an INOpulse® device using an INOpulse® nasal cannula.
15949666|NCT03267108|Combination Product|Open Label Extension|Subjects will be treated by means of an INOpulse® device using an INOpulse® nasal cannula.
15949667|NCT03267095|Behavioral|music therapy sessions .|In this intervention songs compose by the therapist will be use for the study. The songs included the target word .The target words will be selecte from functional vocabularies that typically developing 3years old children can use effectively in everyday interactions.The general criteria for vocabulary words included: names of familiar objects and persons, functional action words such as words for social control , and emotional words . Inherent musical structures structures and organized musical patterns in the songs will be provide .The patients will reflect on the music therapy activity as singing the song together.
15949668|NCT03267082|Other|Laparoscopic management of perforated appendicitis|"Insertion of Ports
~Exposure of the Appendix
~peritoneal toilet and aspiration of pus after abdominal exposure
~Isolation of Mesoappendicular Artery
~Clipping and Dividing of the Artery
~Application of 3 x Endoloops
~Division of the Appendix
~Retrieval of the Appendix in an Endobag"
15949669|NCT03267069|Other|survey|surveys will be administered at inclusion and follow-ups
15949670|NCT03267056|Device|drug eluting balloon catheter (trade name: Orchid)|use drug eluting balloon catheter(trade name: Orchid) to inflate the stenosis or occlusion in superficial femoral artery(SFA) and/or popliteal artery
15949671|NCT03267043|Behavioral|Family Nurture Intervention (FNI)|Subjects will be guided by the nursing staff through an enhanced program of mother/infant interactions, which include skin-to-skin holding.
15949672|NCT03267043|Behavioral|Standard Care|Established routine care provided on the NICU floor by specially trained health care professionals.
15949673|NCT03267030|Drug|GRASPA|Administration of 1-7 doses of 150 IU/kg IV infusion. (every 2 weeks for a maximum of 4 doses and every 6 weeks for maximum 3 doses).
15949674|NCT03267017|Other|posture changes|Following induction of general anesthesia and initiation of positive pressure ventilation, patients will be tilted 15 degrees head up for 5 minutes with positive end expiratory pressure of 8 cm H2O, and then 15 degrees head down for 5 minutes with positive end expiratory pressure of 3 cm H2O
15949675|NCT03267004|Device|Dietary Assessment of Meal A using images taken by Sony Smarteyeglass|"Participant will be wearing Sony Smarteyeglass to record digital images while eating meal A in the laboratory
~Meal A:
~Turkey and Provolone Cheese Sandwich [whole wheat bread 52g(female & male), Turkey 70g(female) & 133g(male), Provolone cheese 23g(female & male), tomato 50g(female & male), lettuce 45g(female & male)]; Chicken and wild rice [chicken 98g(female & male), wild rice 71g(female) & 107g(male)]; chocolate chips cookies [44g(female) & 60.5g(male)]; potato chips [39g(female) & 52g(male)]."
15949676|NCT03267004|Device|Dietary Assessment of Meal B using Images taken by Sony Smarteyeglass|"Participant will be wearing Sony Smarteyeglass to record digital images while eating meal B in the laboratory
~Meal B:
~Ham & Cheddar cheese wrap [Tortilla 45g(female & male), Ham deli 76g(female) & 103g(male), cheddar cheese 21g(female) & 32g(male), Spring Mix 36g(female & male), Fat Free ranch dressing 29g(female & male)]; Pasta with broccoli and Alfredo sauce [Pasta 91g(female) & 121g(male), Broccoli 66g(female & male), Alfredo sauce 38g(female) & 50g(male)]; Chocolate Ice-cream [107g(female), 138g(male)]; Red seedless grapes [365g (female), 471g(male)]."
15949677|NCT03266991|Drug|Rifapentine|Treatment with weekly rifapentine and isoniazid as Directly Observed Therapy in 12 weeks
15949678|NCT03266991|Drug|Isoniazid|Treatment with daily isoniazid in 6 months
15949679|NCT03266965|Drug|Carbidopa|All subjects will receive a fixed dose of 50mg of Lodosyn twice daily.
15949680|NCT03266965|Dietary Supplement|L-Histidine|Sequential Dose Escalation of 250mg to 500mg to 1000mg twice daily.
15949681|NCT03266939|Drug|Lorcaserin|10 mg acute administration of lorcasein
15949682|NCT03266939|Drug|Placebo Oral Tablet|Placebo
15949683|NCT03266926|Drug|Bupivacaine|0.25% Bupivacaine with epinephrine will be applied to vaginal packing that is placed post vaginal reconstruction surgery.
15949684|NCT03266926|Drug|Premarin Vaginal cream|A Premarin vaginal cream will be used to coat the vaginal pack, prior to insertion in patients post vaginal reconstruction surgery.
15949685|NCT03266913|Drug|Probiotic|Probiotics drop
15949686|NCT03266900|Procedure|re-TURBT|2nd bladder biopsy within 4-6 weeks of initial biopsy
15949687|NCT03266900|Drug|6 weeks BCG instillation|standard 6 weeks of BCG induction
15949688|NCT03266861|Diagnostic Test|Exercise oximetry|Sample at rest before the walking test Sample at rest 3 minutes after the end of the walking period
15949689|NCT03266848|Diagnostic Test|Quantitative Magnetic Resonance Imaging|Radiological diagnosis
15949690|NCT03266835|Device|SoundBite™ Crossing System - Peripheral|SoundBite™ Crossing System consisting of the SoundBite™ Console and SoundBite™ Active Wire 18. The Investigator may use the SoundBite™ Active Wire during the procedure to cross the proximal aspect and/or to cross multiple lesions.
15949691|NCT03266822|Other|No intervention|Observational study
15949692|NCT03266796|Behavioral|goal setting process|goal setting process during the first consultation
15949693|NCT03266783|Drug|Apixaban|Refer to Apixaban group
15949694|NCT03266783|Drug|Rivaroxaban|Refer to Rivaroxaban group
15949695|NCT03266770|Device|RELIEF Stent|The RELIEF stent will be placed under cystoscopy. The stent with pusher will be placed over the guidewire and inserted. The pusher will be positioned, the guidewire will be removed, and the pusher will be retracted. The position of the stent will be confirmed by x-ray (C-arm).
15949696|NCT03266744|Diagnostic Test|Computerised Tomography|
15949697|NCT03266744|Diagnostic Test|Whole Body Magnetic Resonance Imaging|
15949698|NCT03266744|Diagnostic Test|Bone scan|
15949699|NCT03266731|Drug|Aspirin|evaluates the safety and efficacy of clopidogrel and aspirin as an alternative treatment in patients not eligible for recombinant tissue plasminogen activator or any other acute reperfusion therapy with acute ischemic stroke (AIS) and transient ischemic attack (TIA) within 24 hours of symptoms onset
15949936|NCT03264781|Drug|Cyclofem|Intramuscularly injection 0.5 ml of Cyclofem or placebo
15949700|NCT03266718|Behavioral|Physical Activity Intervention|To develop and test a couple-based physical activity intervention among cancer survivors and their partners
15949701|NCT03266705|Drug|tafamidis|bioequivalence study
15949702|NCT03266692|Biological|ACTR087|Autologous T cell product
15949703|NCT03266692|Biological|SEA-BCMA|B-cell maturation antigen (BCMA)-directed antibody
15949704|NCT03266679|Other|Metacognitive Reflection and Insight Therapy - Adapted|The intervention involves the following elements: setting an agenda, developing a therapeutic relationship, therapist transparency and insertion of therapist's mind, analysis of narrative episodes, problem definition, stimulating self-reflection and understanding of others, stimulating mastery, reflecting on therapeutic relationship, and client assessment of outcomes.
15949705|NCT03266666|Behavioral|WellnessRX Lifestyle Change Classes|Lifestyle change classes on nutrition, physical activity, and stress management.
15949706|NCT03266666|Other|Thrive Market Grocery Credits (4x$25 each)|Thrive Market is an online grocery service available nationwide. Participants will be provided with up to $100 on grocery credits.
15949707|NCT03266653|Drug|cytotoxic t-lymphocytes|EBV specific CTLs will be generated from HLA related matched and mismatched donors in a GMP facility and administered to the patient with refractory CTLs.
15949708|NCT03266640|Drug|viral specific cytotoxic t-lymphocytes|CMV specific CTLs will be collected from HLA matched or mismatched donors and manufactured in a GMP facility and administered to patients with refractory CMV infection.
15949709|NCT03266627|Drug|cytotoxic t-lymphocytes|adenovirus specific cytotoxic t-lymphocytes will be collected and manufactured from HLA matched related or HLA mis-matched related donors and administered to eligible patients with refractory adenovirus or PID.
15949710|NCT03266614|Behavioral|Recovery 4 Us|R4US is a social media program aimed at the enhancement of community participation and overall recovery of individuals with psychiatric disabilities.
15949711|NCT03266601|Drug|Recombinant Human Interferon α-2b Spray|Recombinant human interferon α-2b spray (trade name Jeferon, specifications: 1 million U/support, 10mL/support or 2 million U/support, 20mL/support, 2-8 ℃ dark storage and transportation), 1 million U/day, used for 3 days, observed to the 4th day (until the 96th hour).
15949712|NCT03266601|Drug|Ribavirin|Ribavirin Spray, spray once every 4-5 hours, 1-2 times a spray, used for 3 days, observed to the 4th day(until the 96th hour ).
15949713|NCT03266588|Drug|Rimegepant|75 mg oral tablet
15949714|NCT03266575|Behavioral|Pulmonary Rehabilitation Exercise|Participants will undergo Pulmonary Rehabilitation exercise. Participants will perform endurance (treadmill or cycle ergometer), strength (weight resistance) and flexibility training twice a week for a period of an hour per session
15949715|NCT03266575|Behavioral|Home Based Exercise|Participants will undergo Home based exercise program consisting of strength and conditioning. Participants will perform REST for 10 minutes daily, increasing to 20 minutes daily, after the second week, in their home environment. The total duration of the intervention will be 12 weeks. Participants will be provided with pedometers, REST video and binder, with instructions on how to perform exercises, and resistance bands.
15949716|NCT03266562|Diagnostic Test|F-18 FES|Evaluate uptake of F-18 FES in breast tissue
15949717|NCT03266562|Diagnostic Test|F-18 FDG|Evaluate uptake of F-18 FDG in breast tissue
15949718|NCT03266549|Procedure|botulinum toxin augmented surgery|unilateral recess-resect procedure, or bilateral rectus muscle recession plus intraoperative injection of 2.5 to 5 units of botulinum toxin A into the recessed muscle.
15949719|NCT03266549|Procedure|conventional surgery|unilateral recess-resect procedure, bilateral rectus muscle recession, or 3 horizontal rectus muscle surgery according to the type of strabismus and the presence or absence of deep amblyopia. The standard correction tables will be used as a guide for the amount of muscle recession and, or resection.
15949720|NCT03266536|Behavioral|Western diet|Western diet for 7 days: the meals in this Western diet will be provided by the Clinical Research and Trials Unit (CRTU) after participants meet with the nutrition staff (to discuss food preferences, how to obtain the meals). The meals will reflect a typical Western diet: a low fiber, high sugar diet with weight maintenance calories with < 10 grams fiber per day, and a typical US macronutrient calorie distribution of 50% carbs, 35% fat and 15% protein, with no alcohol. At least 50% of carbohydrates will be provided as simple sugars.
15949721|NCT03266523|Other|Natural images in imaging waiting rooms|Standard environment for hospital imaging waiting rooms
15949722|NCT03266510|Other|Inspiratory muscle strength training|Subjects will perform inspiratory muscle strength training for 6 weeks.
15949723|NCT03266510|Other|Sham training|Subjects will perform sham training for 6 weeks.
15949724|NCT03266484|Dietary Supplement|Probiotic Mixture|The probiotic supplement contains 8 different strains of bacteria and participants will be dosed in two dosages per a total of 40 billion bacteria daily.
15949725|NCT03266484|Dietary Supplement|Placebo|A placebo which is identical to the probiotic mixture. Participants will be dosed in two dosages daily.
15949726|NCT03266471|Diagnostic Test|Baseline blood sample|Blood sample for cytokine measurements and genetics.
15949727|NCT03266471|Diagnostic Test|Baseline intestinal biopsies|Up to 20 additional biopsies will be obtained at the time of standard of care colonoscopy. It is not felt that additional biopsies substantially increases the risk of a colonoscopy. Cytokine measurements will be performed on the tissue collected.
15949728|NCT03266471|Other|Crohn's disease activity index (CDAI)|To determine response, a Crohn's Disease Activity Index (CDAI) score will be obtained at time point 1 and time point 2 in all enrolled CD patients. The CDAI is a well validated symptom index for CD which assesses 8 factors including stool frequency, abdominal pain, general well being, CD complications, HCT, and deviation from ideal body weight.
15949729|NCT03266471|Diagnostic Test|Post treatment blood sample|Blood sample for cytokine measurements after patients have been on therapy for at least 6 weeks but no more than 52 weeks.
15949730|NCT03266471|Diagnostic Test|Post treatment intestinal biopsies|Up to 20 additional biopsies will be obtained at the time of standard of care colonoscopy at least 6 weeks but no more than 52 weeks after initiation of therapy. It is not felt that additional biopsies substantially increases the risk of a colonoscopy. Cytokine measurements will be performed on the tissue collected.
15949731|NCT03266471|Diagnostic Test|Baseline stool sample|Stool sample for inflammatory markers or microbiome analysis.
15949732|NCT03266471|Diagnostic Test|Post treatment stool sample|Stool sample for inflammatory markers or microbiome analysis.
15949733|NCT03266458|Procedure|Primary percutaneous coronary intervention|Urgent percutaneous coronary intervention for ST- elevation myocardial infarction patients.
15949734|NCT03266445|Drug|buprenorphine/naloxone|The intervention will be to either continue taking buprenorphine/naloxone or to have the medication reduced perioperatively.
15949735|NCT03266432|Other|blood samples|three blood samples : first one pre intervention and the other two blood samples post-intervention
15949736|NCT03266419|Drug|Deep NMB using rocuronium|"Drug: rocuronium
~Bolus dose: 0.7 mg/kg
~Continuous infusion : 0.8-1.2 mg/kg/h for maintaining deep NMB (post tetanic count 1-2) during operation."
15949737|NCT03266419|Drug|Moderate NMB using rocuronium|"Drug: rocuronium
~Bolus dose: none
~Continuous infusion: 0.2-0.6 mg/kg/h for maintaining moderate NMB (train of four 1-2) during operation."
15949738|NCT03266406|Drug|Hyaluronidase|4ml of retrobulbar LA with addition of 15IU/ml hyaluronidase to 2% lidocaine
15949739|NCT03266393|Drug|Envarsus XR|Once daily sustained-release tacrolimus
15949740|NCT03266393|Drug|Tacrolimus|Twice daily immediate-release tacrolimus
15949741|NCT03266380|Diagnostic Test|observational|All patients do an emergency brain computed tomography scan. Intracranial hypertension is treated with mannitol with or without a craniotomy. A third generation cephalosporin (ceftriaxone) and metronidazole are administered as antibiotic prophylaxis for accompanying wound injuries (skin and soft tissue). VAP preventive strategies that are performed in the ICU include daily interruption of sedation and a readiness to extubate assessment, early facilitation of mobility, elevating the head of the bed to 30- 45 degree, change of the ventilator circuit if visibly soiled or malfunctioning, stress ulcer prophylaxis, residual gastric volume monitoring, early parenteral nutrition, and deep venous thrombosis prophylaxis. An infusion of midazolam and propofol is to be used for sedation.
15949742|NCT03266367|Diagnostic Test|Neutrophil gelatinase-associated lipocalin (NAGL)|Serum level of Neutrophil gelatinase-associated lipocalin (NAGL) using the enzyme linked immunosorbent assay kits (ELISA)
15949743|NCT03266354|Procedure|specular microscopy before and after Artisan PIOL|specular microscopy will be performed before and after implantation of the rigid Artisan iris-fixated pIOL to analyze the change in corneal endothelial cell count
15949744|NCT03266341|Diagnostic Test|Cultures|Take different samples anddetection of anaerobes on enriched blood agar and other selective anaerobic cultures
15949745|NCT03266328|Procedure|Primary Percutaneous Coronary Intervention (PPCI)|Percutaneous Coronary Intervention in patients of acute myocardial infarction diagnosed using ECG findings
15949746|NCT03266315|Biological|FloraBaby|1 sachet will be added to a minimum of 1 mL of brest milk, sterile water or formula (in formula fed babies) once a day
15949747|NCT03266315|Other|Placebo|1 sachet will be added to a minimum of 1 mL of brest milk, sterile water or formula (in formula fed babies) once a day
15949748|NCT03266302|Device|hemoadsorber for removal of cytokines|Use of the hemoadsorber during cardiac surgery with CPB. Hemoadsorber is integrated into the CPB circuit according to manufacturer's recommendation.
15949749|NCT03266276|Other|PSOPC pathway approach|"The intervention will use a standardized PSOPC pathway approach, prompted follow up with patients and documentation.
~Additionally, clinicians will be prompted to document conversations about response to emotional or physical ESAS symptom scores, symptom management plan (self/education/monitoring/medication), illness understanding; and, if necessary, an offer of PSO/PC referral."
15949750|NCT03266263|Device|automatic computer-led feedback|automated feedback software for CPR quality, including compression depth, rate, recoil, hands-off time, and ventilation volume
15949751|NCT03266263|Other|instructor-led feedback|feedback for CPR quality by instructors
15949752|NCT03266250|Procedure|spinal anesthesia|Transthoracic echocardiography of inferior vena cava before spinal anesthesia
15949753|NCT03266237|Drug|Vaxigrip®|To describe the humoral immune response to Vaxigrip (IM) vaccination at Day 0 (baseline) and Day 28 according to the age and frailty status at baseline (i.e. in each study group) for each Influenza strain.
15949754|NCT03266211|Other|Questionnaire Patients|Patient will have to answer a quiz which is about their vaccination against tetanus.
15949755|NCT03266211|Other|Questionnaire General practitioner|General practitioner will have to answer a quiz which is about their medical practice concerning vaccination against tetanus.
15949756|NCT03266198|Other|No intervention|No intervention
15949757|NCT03266185|Other|Shorter PICT|Shorter post-infusion cooling time
15949758|NCT03266172|Drug|GSK2982772 Modified Release|GSK2982772 MR will be available as prototype MR minitablet in capsules with unit dose strength of 60 mg in Part A. In Part B, GSK2982772 MR minitablet in capsules with unit dose strength of 15, 30 or 60 mg will be administered by subjects for Days 1 to 3. In Part C, GSK2982772 MR tablet with unit dose strength of 240, 360 or 480 mg will be administered by subjects. GSK2982772 MR will be administered orally with 240 mL of water.
15949759|NCT03266172|Drug|GSK2982772 Immediate Release|In part A, GSK2982772 IR tablet will be available with unit dose strength of 30 mg and the total dose administered by subjects will be 120 mg (4 tablets of dose strength 30 mg) orally with 240 mL of water. In part C, GSK2982772 IR tablet will be available with unit dose strength of 30 mg and the total dose administered by subjects will be 240 mg (8 tablets of dose strength 30 mg) orally with 240 mL of water.
15949760|NCT03266159|Drug|GSK525762 Besylate tablets|GSK525762 Besylate film coated tablets will be available as a 20 mg tablet strength, yellowish pink in color, round and biconvex with no markings. It will be administered with 240mL of liquid.
15949761|NCT03266159|Drug|Trametinib tablets|"Trametinib film coated tablets will be available as 0.5 mg and 2 mg dose strengths. Trametinib 0.5 mg will be yellow colored, modified oval, biconvex, tablets with 'GS' debossed on one face and 'TFC' on the opposing face.
~Trametinib 2 mg will be pink colored, round, biconvex tablets with 'GS' debossed on one face and 'HMJ' on the opposing face. Doses will be taken at least 1 hour before or at least 2 hours after a meal."
15949762|NCT03266146|Drug|36 Weeks Methylprednisolone|Participants in 36 weeks of glucocorticoid treatment group will receive methylprednisolone, 48mg/d for the 1st week, 32mg/d for the 2nd week, 24mg/d for the next two weeks, followed by 16mg/d for 20 weeks and reduction in doses of methylprednisolone by 4 mg per 4 weeks until drug withdrawal. Participants in 36 weeks of glucocorticoid treatment group also will receive standard treatment including reduced glutathione, glycyrrhizin, ademetionine, alprostadil, or ursodeoxycholic acid (UDCA).The total treatment duration will be 36 weeks. Follow-up duration is 24 weeks.
15950289|NCT03262103|Biological|Intramuscular (IM) Poly ICLC|1 mg IM twice weekly (weeks 3-6)
15949763|NCT03266146|Drug|48 weeks Methylprednisolone|Participants in 48 weeks of glucocorticoid treatment group will receive methylprednisolone, 48mg/d for the 1st week, 32mg/d for the 2nd week, 24mg/d for the next two weeks, followed by 16mg/d for 32 weeks and reduction in doses of methylprednisolone by 4 mg per 4 weeks until drug withdrawal. Participants in 36 weeks of glucocorticoid treatment group also will receive standard treatment including reduced glutathione, glycyrrhizin, ademetionine, alprostadil, or ursodeoxycholic acid (UDCA).The total treatment duration will be 48 weeks. Follow-up duration is 24 weeks.
15949764|NCT03266133|Behavioral|Sleep Education for Pregnancy|Sleep education specific to pregnancy
15949765|NCT03266120|Other|Art|Participants will receive a hands-on art activities intervention consisting of two art activities sessions each week lasting approximately 60 minutes each in duration for four weeks for a total of eight sessions. Art activities will include hand papermaking, image transfer, visual storytelling, linocut printmaking, paper batik, mixed media collage, and sensation drawing based activities. Participants will complete sets of self-report psychometric assessments before, during, and following the art intervention. Heart rate and blood pressure will be monitored before, during, and following completion of the art intervention.
15949766|NCT03266120|Other|Gardening|Participants will receive a hands-on gardening intervention consisting of two gardening sessions each week lasting approximately 60 minutes each in duration for four weeks, for a total of eight sessions. Gardening activities will include planting seeds, bulbs and tubers, transplanting seedlings, vegetative propagation and sight, smell, taste and touch sensory based activities. Participants will complete sets of self-report psychometric assessments before, during, and following the gardening intervention. Heart rate and blood pressure will be monitored before, during, and following completion of the gardening intervention.
15949767|NCT03266107|Device|Intracept|Radiofrequency ablation of the basivertebral nerve using the Intracept System
15949768|NCT03266094|Device|BiZact™: A bipolar instrument for tonsillectomies|A bipolar electrosurgical device that employs RF energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger.
15949769|NCT03266081|Drug|0.75% bupivacaine|topical anesthetic
15949770|NCT03266068|Genetic|DNA Analysis of Blood Sample|DNA analysis of the genes possibly involved in IBS.
15949771|NCT03266068|Procedure|Flexible sigmoidoscopy with colonic biopsies|Endoscopy of the subject's lower colon in which biopsies of the lining of the colon will be taken.
15949772|NCT03266068|Procedure|Small bowel and colonic gastrointestinal permeability|A validated scintigraphic method to measure gastric, small bowel and colonic transit will be used.
15949773|NCT03266068|Diagnostic Test|Stool sample analysis|Stool samples will be used to extract supernatants. These supernatants will be studied in using chamber set-up to determine barrier effects on T84 monolayers.
15949774|NCT03266055|Dietary Supplement|50 g of blueberry powder, taken daily for 8 weeks|Subjects will consume blueberry powder during 8 weeks to test the possible effects of blueberries on gut microbiota composition and on metabolic syndrome parameters.
15949775|NCT03266055|Dietary Supplement|50g of placebo blueberry powder, taken daily for 8 weeks|Subjects will consume blueberry placebo powder to test if there is a significant difference on the impact on gut microbiota composition and metabolic syndrome parameters between this treatment and the active treatment (blueberry powder).
15949776|NCT03266029|Device|Cordio App|
15949777|NCT03266016|Other|Computerized Ventilator Protocol|Computerized Decision Support System which recommends changes to ventilator settings to promote physiologic levels of patient effort of breathing.
15949778|NCT03266016|Diagnostic Test|Esophageal Manometry|Esophageal Manometry Catheter to measure effort of breathing an transpulmonary pressure
15949779|NCT03266016|Diagnostic Test|Respiratory Inductance Plethysmography (RIP)|RIP bands to measure thoraco-abdominal synchrony during spontaneous breathing trials
15949780|NCT03266016|Diagnostic Test|Diaphragm Ultrasound|Daily measurement of diaphragm thickness and diaphragm contractile activity
15949781|NCT03266016|Diagnostic Test|Maximal Inspiratory Pressure|Prior to Spontaneous breathing trials, measurement of airway and esophageal maximal inspiratory pressure during airway occlusion
15949782|NCT03266003|Other|Electronic DOT|"Electronic DOT is the use of electronic communication methods to observe patients swallow anti-TB drugs and monitor for medication side effects. This study will use two variations of electronic communication methods, referred to as electronic directly observed therapy or eDOT. This includes: (1) eDOT conducted live in which TB program staff interact with patients via a computer or phone application as they ingest their medication (eDOT-live), and (2) eDOT conducted using time stamped, recorded videos in which TB program staff log into an electronic system and review videos recorded by patients in order to verify that patients ingested their medication doses as scheduled (eDOT-recorded)."
15949783|NCT03266003|Other|In-person DOT|A trained person is in the physical presence of patients as anti-TB drugs are ingested.
15949784|NCT03265990|Procedure|ligasure haemroidectomy|In ligasure group,After the haemorrhoids are prolapsed out from the anal canal with an artery forceps,Ligasure haemorrhoidectomy will be performed by applying the ligasure forceps close to the edge of each pile.Repeated applications of the device will be performed and excision will be continued into the anal canal,lifting the pile from the internal anal sphincter,to the level of the vascular pedicle,which will be finally divided.
15949785|NCT03265990|Procedure|Conventional haemorrhoidectomy|"According to the Ferguson technique
~Manual anal sphincter stretching up to 4 fingers
~Delivery of hemorrhoidal masses with artery forceps,one being applied at the base of haemorrhoid,the other at the apex.
~skin incision at the base of haemorrhoids and submucosal dissection to lift the haemorrhoid mass off the internal sphincter.
~After this the haemorrhoid pedicle will be transfixed and the mucosal edges of the defect will be opposed."
15949786|NCT03265977|Biological|H56:IC31|The H56 antigen is a fusion protein created from 3 Mtb antigens: antigen 85B (Ag85B), ESAT-6, and Rv2660c.
15949787|NCT03265977|Other|Placebo|Normal saline
15949788|NCT03265964|Drug|Uridine|Uridine is the active treatment in this clinical trial.
15949789|NCT03265964|Drug|Placebo|Pill placebo is the inactive treatment comparator in this clinical trial.
15949790|NCT03265951|Drug|Ramelteon|8 mg once daily administered within 30 minutes of bedtime
15949791|NCT03265951|Other|Usual Care|education brochure about sleep hygiene
15949896|NCT03265119|Drug|AEVI-001|Oral doses of 100 mg, 200 mg or 400 mg of AEVI-001 will be administered twice daily during the treatment period.
15949792|NCT03265938|Device|Indirect Laryngoscopy|The attending anesthesiologist will perform video laryngoscopy with the C-MAC D video laryngoscope and with the GlideScope AVL video laryngoscope and grade the view of the larynx obtained with each laryngoscope.
15949793|NCT03265899|Drug|Oxytocin|40 IU; 5 puffs balanced across nostrils, at an inter-puff interval of 30 seconds
15949794|NCT03265899|Drug|Placebo|Placebo nasal spray, 5 puffs balanced across nostrils, at an inter-puff interval of 30 seconds
15949795|NCT03265886|Drug|Warm bupivacaine at (37°c)|Bupivacaine 0.5%, 30 mL, warmed to 37◦C for 20 minutes. The empty syringes and needles, in their packaging, will be held at the same temperature before initiating the block.
15949796|NCT03265886|Drug|Bupivacaine at operating room temperature (23°c)|Bupivacaine 0.5%, 30 ml held in crash shelf of the operating room temperature at 23◦C. The empty syringes and needles will be held in the same temperature before use.
15949797|NCT03265873|Other|Systematic consideration of the advice of the ENT surgeon in the determination of the radiotherapy target volumes in head and neck cancers.|The contouring of the different target volumes will be first performed by the radiotherapists. During the Head and Neck Tumor Board, the volumes initially determined by the radiotherapists will be analyzed jointly by the radiotherapists and the patient's ENT surgeon to carry out, if necessary, modifications, taking into account clinical observations, intraoperative findings (if any) and endoscopy findings. Concordance parameters will be calculated in a second time with the determined volumes (in particular, index of concordance, coefficient of similarity).
15949798|NCT03265860|Device|IntraVoxel Incoherent Motion sequence|The IVIM diffusion sequence with a duration of 2 minutes is added to the imaging protocol.
15949799|NCT03265847|Behavioral|Culturally-tailored Safety Planning|The intervention will provide safety planning/referrals tailored to the DA
15949800|NCT03265834|Other|< 10 days of antibiotics|Antibiotic duration
15949801|NCT03265834|Other|28 days of antibiotics|Antibiotic duration
15949802|NCT03265821|Procedure|Healing after treatment|
15949803|NCT03265808|Drug|allogeneic human mesenchymal stem cells (allo-hMSCs)|Single administration of allogeneic hMSCs: 100 x 106 (100 million) allo-hMSCs of cells delivered via a single peripheral intravenous infusion.
15949804|NCT03265808|Drug|Placebo|Placebo administration consisting of 1% human albumin serum in Plasma-Lyte A delivered via a single peripheral intravenous infusion.
15949805|NCT03265795|Device|Poly Ether Ether Ketone PSI (patient specific implant).|reconstruction of the bone and the original volume of maxillary sinus accurately (in terms of clinical and radiographic parameters).
15949806|NCT03265782|Drug|ibuprofen|drug was adminstred with a loading dose 10 mg/kg/day followed by 5 mg/kg/day in 2 doses with 24 hrs apart for 3 days
15949807|NCT03265782|Drug|paracetamol|drug was administred for 3 consequetive days in a dosev 15 mg/kg/dose every 6 hrs and follow up echo was done after 3 days
15949808|NCT03265769|Other|radial access site|radial route
15949809|NCT03265769|Other|femoral access site|femoral route
15949810|NCT03265756|Device|Multimometer|A device for measuring respiration rate, temperature, heart rate and the degree of blood oxygenation of children
15949811|NCT03265743|Other|Self-report Written Questionnaire|Informations are gathered through a self-report written questionnaire, completed by the patients or their parents.
15949812|NCT03265717|Biological|INVAC-1|Patients are treated by INVAC-1 for 6 cycles at 4-week intervals
15949813|NCT03265704|Other|AGA - Control group|Data processing from Patient Medical Files
15949814|NCT03265704|Other|SGA - Control group|Data processing from Patient Medical Files
15949815|NCT03265704|Other|AGA-PIH Study group|Monitoring PIH-related changes in the newborn
15949816|NCT03265704|Other|SGA-PIH Study group|Monitoring PIH-related changes in the newborn
15949817|NCT03265691|Other|Early detection and treatment of hyponatremia|In the experimental group, hyponatremia will be diagnosed and treated early. Therefore, the researchers will review the patients' sodium levels at admission and throughout their stay.
15949818|NCT03265691|Other|No Intervention (SOC)|Usual pattern of work will be performed in all patients who enter in Hospital.
15949819|NCT03265665|Behavioral|ACTION Intervention|The intervention is based on the Women's Lifestyle Physical Activity Program, a culturally sensitive lifestyle physical activity intervention for African American (AA) women. There are 2 phases to the intervention: Adoptive (24 weeks) and Maintenance (12 weeks). 3 motivational/reminder texts will be made each week during the adoption phase. 5 Group sessions(adoptive): Participants will be given individualized step goals, watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking. 1 Group session (maintenance): watch a short DVD featuring AA women demonstrating skills and sharing experiences of engaging in walking, reinforce barriers and facilitators to walking. An interventionist will lead a discussion on role-modeling and encouraging problem solving. Each intervention group will have 10 women with 1 interventionist. Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks.
15949820|NCT03265665|Other|Enhanced usual care|"Participants will attend 1 two hour asthma education/physical activity session at community location near them. Participants will review basic asthma topics in a didactic session and will include exercising with asthma and exercise-induced asthma. Participants will be given Fitbit and provided instructions on how to use it. Participants may receive 2 newsletters with information on asthma and reminder texts regarding data collection visits.
~Data will be collected at 3 time points: baseline, 24-weeks and 36-weeks."
15949821|NCT03265652|Device|Intense Pulsed Light (IPL) therapy|Intense pulsed light therapy is a non-invasive and non-laser light treatment that is FDA-approved for various conditions in dermatology. Subjects will receive a total of 4 treatments over the course of the study, at intervals of 2 weeks. Each treatment will include applications on 10-15 IPL pulses in the malar region and close to the lower eyelids, followed by meibomian gland expression. Meibomian gland expression will be implemented by squeezing the meibomian glands with the aid of two Q-tips positioned on either side of the meibomian glands, or with a meibomian gland expressor forceps.
15949822|NCT03265652|Device|Sham therapy|Subjects will receive a total of 4 treatments over the course of the study, at intervals of 2 weeks. Each treatment will include a sham application of IPL on 10-15 locations in the malar region and close to the lower eyelids, followed by meibomian gland expression. Meibomian gland expression will be implemented by squeezing the meibomian glands with the aid of two Q-tips positioned on either side of the meibomian glands, or with a meibomian gland expressor forceps.
15949823|NCT03265639|Dietary Supplement|P-inulin|
15949824|NCT03265626|Behavioral|Intervention 1: Comprehensive preventive intervention|aims to implement the existing evidence and policy documents Advocacy workshop to politicians, Community mobilization, Awareness creation on women,training community representative, Husband participation
15949825|NCT03265626|Behavioral|Intervention 2: Awareness creation and community mobilization|Advocacy politicians, Community mobilization, Awareness creation to women, Training community representative
15949826|NCT03265626|Other|available standard care|The standard care will be maintained but no other additional intevvenion designed by this study
15949827|NCT03265613|Biological|adipose-derived multipotent mesenchymal stem cells|AD-MSCs(adipose-derived multipotent mesenchymal stem cells) were infused intravenously at a dose of 0.5 million cells/kg.
15949828|NCT03265600|Behavioral|Mindfulness Training for Primary Care|MTPC is a referral-based, insurance-reimbursable 8-week program that can be delivered as group psychotherapy by Patient-Centered Medical Home-integrated behavioral clinicians or as an 8-week primary care group visit delivered by a primary care provider. MTPC groups are 2 hours long for 8 weeks with a 7-hour weekend day of silent practice. MTPC emphasizes mindfulness-oriented skills for self-regulation, self-management of chronic illness, and health behavior change. All participants complete an action planning protocol during Week 7.
15949829|NCT03265600|Behavioral|60-minute Introduction to Mindfulness|Participants in the low-dose comparator arm receive a 60-minute introduction to mindfulness. Participants are introduced to the definition(s) of mindfulness, brief mindfulness practices, discussion, and an orientation to an 8-week mindfulness group. They are also given a list of leading community, online, print, and smartphone mindfulness resources.
15949830|NCT03265587|Other|No intervention|No intervention
15949831|NCT03265574|Drug|Enalapril|Enalapril is an Angiotensin Converting Enzyme (ACE) inhibitor which supresses the reninangiotensin-aldosterone system resulting in increased plasma renin activity and decreased aldosterone secretion
15949832|NCT03265561|Device|Bone allograft|All patients will undergo the same surgical procedure consisting of open surgery, more debridement of infected and devitalized tissue, as well as corresponding bone resection. For the identification of the microorganism, biopsies will be performed by puncture guided by CAT and / or fluoroscopy, and culture and antibiogram will be performed in case of not obtaining enough material for this, at the time of the surgery samples will be sent to perform the same procedure. We will use the appropriate antibiotics, according to infecting microorganism and result of antibiogram. We will include patients with infections with gram positive and negative microorganisms only. This patients will go stabilized with bone allograft only.
15949833|NCT03265561|Device|Bone auto and allograft group|All patients will undergo the same surgical procedure consisting of open surgery, more debridement of infected and devitalized tissue, as well as corresponding bone resection. For the identification of the microorganism, biopsies will be performed by puncture guided by CAT and / or fluoroscopy, and culture and antibiogram will be performed in case of not obtaining enough material for this, at the time of the surgery samples will be sent to perform the same procedure. We will use the appropriate antibiotics, according to infecting microorganism and result of antibiogram. We will include patients with infections with gram positive and negative microorganisms only. This patients will go stabilized with bone autograft plus bone allograft
15949834|NCT03265548|Device|Video Laryngoscope|The use of video laryngoscopy
15949835|NCT03265535|Diagnostic Test|Single-Scan Two-Injection Protocol|Single-Scan Two-Injection Protocol
15949836|NCT03265522|Behavioral|"ThinkMed resource at baseline"|"The ThinkMed resource contains an information booklet, recipe books, menu plan cards, shopping list cards and goal setting cards. Participants will receive this resource on one occasion at baseline."
15949837|NCT03265522|Behavioral|Standard Care Control|"Participants will continue with the standard care provided by their physician. Participants will receive the ThinkMed resource after their final 6 month study visit (i.e. delayed intervention)."
15949838|NCT03265522|Behavioral|"ThinkMed resource (staged)"|"This group of participants will receive the ThinkMed resource at monthly intervals for 5 months accompanied by telephone feedback from the research dietitian"
15949839|NCT03265509|Dietary Supplement|glutamine supplementation|30 g/day glutamine supplementation for three months
15949840|NCT03265509|Dietary Supplement|fantomalt supplementation|30 g/day fantomalt supplementation for three months
15949847|NCT03265483|Dietary Supplement|Magnesium glycinate|Oral administration of magnesium glycinate daily for 12 weeks
15949848|NCT03265483|Dietary Supplement|Placebo|Oral administration of identical-appearing placebo daily for 12 weeks
15949849|NCT03265470|Drug|Dexmedetomidine|Patients will receive Loading dose of dexmedetomidine (0.8μg/kg) over 20 minutes, followed by intravenous infusion (0.4μg/kg/h) during intra-operative period till end of procedure.
15949850|NCT03265470|Drug|Fentanyl|Patients will receive Loading dose of fentanyl (1μg/kg), followed by intravenous infusion (1μg/kg/h) during intra-operative period till end of procedure.
15949851|NCT03265457|Other|Specular microscopy|Comparison between corneal Endothelial count in patients with pseudoexfoliation syndrome and age matched group
15949852|NCT03265444|Biological|CS10BR05|The single injection of CS10BR05 Inj. in the carotid artery; Step 1 dose : 3.0x105cells/kg; Step 2 dose : 6.0x105cells/kg; Step 3 dose : 9.0x105cells/kg; The duration of follow up study following the single dose of CS10BR05 is 28 days.
15949853|NCT03265431|Drug|18F-TPP|Imaging with 18-F-TPP (18F-BFPET)
15949854|NCT03265418|Device|BioXmark liquid fiducial markers|Before the start of the treatment planning during an extra sigmoidoscopy after enema preparation, 4 liquid marker spots will be placed 1 cm from the tumor; two in the in the cranial and two in the caudal direction of the tumor (4 markers in total per patient).
15949855|NCT03265418|Other|Imaging|"As part of standard patient set-up directly before each radiotherapy treatment, kV cone-beam CTs will be acquired. Treatment positioning will be based on the regular clinical decision protocols for treatment of rectal cancer and not on the markers. During treatment potential fiducial movement will be assessed using an externally positioned ultra-sound probe, positioned against the abdominal or perineal skin of the patients depending on de position of the tumor/fiducials in the rectum. For patients in this study 2 orthogonal kV images will be made immediately after each radiation using the electronic portal imaging (EPI) device.
~As part of standard clinical practice an MR of the rectum will be made for response evaluation 6-8 weeks after the end of neo-adjuvant chemo-radiotherapy."
15949856|NCT03265418|Procedure|surgery or wait-and-see|"As part of standard clinical practice patients whose tumor has not responded completely will be operated on 8-12 weeks after the end of neoadjuvant chemo-radiotherapy. Patients with a complete response will be follow-upped according to the wait-and-see protocol."
15949857|NCT03265405|Drug|Low dose prednisolone|An initial dose of 20 mg/day will be administered for 8 weeks, followed by 15 mg/day for 8 weeks, 10 mg/day for 4 weeks, and 5 mg/day for 4 weeks, after which the drug will be discontinued.
15949858|NCT03265405|Drug|Medium dose prednisolone|An initial dose of 40 mg/day will be administered for 4 weeks, followed by 30 mg/day for 4 weeks, 20 mg/day for 4 weeks, 15 mg/day for 4 weeks, 10 mg/day for 4 weeks, and 5 mg/day for 4 weeks, after which the drug will be discontinued.
15949859|NCT03265392|Other|Bread|Serving of wheat bread providing 50 g of carbohydrates
15949860|NCT03265392|Other|Water|250 mL of water
15949861|NCT03265392|Other|Lemon juice|250 mL of lemon juice
15949862|NCT03265392|Other|Tea|250 mL of tea
15949863|NCT03265392|Other|Peas|20 peas
15949864|NCT03265379|Other|FACT-B and Brief Pain Inventory|Quality of Life Questionnaires
15949865|NCT03265366|Device|MRI|It will be performed on a 1.5-Tesla MR scanner (MAGNETOM Avanto, Siemens Healthcare, Erlangen, Germany), without injection or inhalation of contrast agent.
15949866|NCT03265366|Device|CT scan (standard reference)|It will be performed on a 16 (Sensation 16, Siemens®) or 64 channels (Definition 64, Siemens®), without contrast agent injection.
15949867|NCT03265353|Other|Moderate Potassium/Low Sodium Diet|7 days of the prescribed diet
15949868|NCT03265353|Other|Moderate Potassium/High Sodium Diet|7 days of the prescribed diet
15949869|NCT03265353|Other|High Potassium/High Sodium Diet|7 days of the prescribed diet
15949870|NCT03265340|Device|dTMS|
15949871|NCT03265327|Dietary Supplement|Oral supplement containing omega-3 and omega-6|An oral supplement containing omega-3 and omega-6
15949872|NCT03265327|Dietary Supplement|Oral supplement containing coconut and olive oil|An oral supplement containing coconut oil and olive oil
15949873|NCT03265314|Behavioral|LeadHer|The 30-hour curriculum is delivered for five hours per week, either split over multiple after school sessions or one five-hour-long session conducted at AFG headquarters or a community-based partner site.
15949874|NCT03265314|Behavioral|Sassy Science|The 30-hour curriculum is delivered for five hours per week, either split over multiple after school sessions or one five-hour-long session conducted at AFG headquarters or a community-based partner site.
15949875|NCT03265301|Procedure|Hysteroscopy|Includes Video set up, mini-hysteroscope system, continuous inflow and outflow, rod lens or fiber optic lens Zero to 30 degree angle and mechanical instruments (Scissors,Graspers , Cup biopsy forceps and bipolar instruments)
15949876|NCT03265301|Procedure|Office hysteroscopy|will be done in out patient clinic without anesthesia
15949877|NCT03265301|Procedure|Conventional hysteroscopy|will be done in operative room under general anesthesia
15949878|NCT03265288|Drug|LAU-7b|LAU-7b will be administered orally once-a-day with the first meal of the day as cycles of 21 days on, 7 days off, for a total of 6 planned cycles.
15949879|NCT03265288|Drug|Placebo oral capsule|Placebo will be administered orally once-a-day with the first meal of the day as cycles of 21 days on, 7 days off, for a total of 6 planned cycles.
15949880|NCT03265275|Other|Fast track patient pathway|Prehospital services establish a working diagnosis of hip fracture and initiate first line treatment. In the emergency department a specially trained nurse triages the patient. Patients without signs of other acute disease or trauma and who have not previously been operated in the same hip are directly transported to the x-ray suite. The x-rays are reviewed by the radiographer and in case of an obvious fracture of the hip the patient is transported directly to the orthopedic ward where the patient is received by a nurse and seen by an orthopedic surgeon. The pathway includes standard procedures for blood sampling, pain relief, including a fascia iliaca compartment block, intravenous fluids, transfusion triggers, management of anticoagulants and premedication. The pathway puts focus on prevention of pressure sores, a short preoperative fasting period and early mobilization. Screening tools are used to assess for delirium, nutritional status and fall risk.
15949881|NCT03265262|Diagnostic Test|The basophil activation test (BAT)|Single sample: 5 mL of venous blood
15949882|NCT03265249|Device|BRIDGE device|an externally placed, FDA-cleared device that delivers percutaneous electrical stimulation with alternating frequencies to branches of cranial nerves (V, VII, IX, and X) through the external ear via a field effect
15949883|NCT03265236|Diagnostic Test|Anti - modified citrullinate vimentin|patients with early and late RA
15949884|NCT03265223|Drug|0.2% ropivacaine|Intraperitoneal instillation versus intraincisional infiltration
15949885|NCT03265210|Behavioral|RELIEF|A 9-week behavioral intervention for primary care designed to reduce depression and pain-related disability.
15949886|NCT03265197|Drug|Intra-tympanic injection of drugs|Intratympanic injection of combined lidocaine and dexamethasone in treatment of tinnitus
15949887|NCT03265197|Other|Data management of intratympanic drugs|intervention by statistical analysis of Intratympanic injection of combined lidocaine and dexamethasone in treatment of tinnitus
15949888|NCT03265184|Dietary Supplement|green coffee extract|Patients in treatment group take 400 mg GCE supplements twice a day for tow month
15949889|NCT03265171|Biological|Plasminogen (Human)|
15949890|NCT03265145|Drug|Stiolto Respimat|Duration - 12 months
15949891|NCT03265145|Drug|ICS (Inhaled Corticosteroid) (Triple therapy)|Duration - 12 months
15949892|NCT03265145|Drug|LABA (Long-Acting Beta Agonist) (Triple therapy)|Duration - 12 months
15949893|NCT03265145|Drug|LAMA (Long-Acting Muscarinic Antagonist) (Triple therapy)|Duration - 12 months
15949897|NCT03265119|Drug|Placebo|Oral doses of 100 mg, 200 mg or 400 mg of Placebo will be administered twice daily during the treatment period.
15949898|NCT03265106|Biological|BinD19|Autologous T cells purified from the peripheral blood mononuclear cells of subjects, transduced with TCR- ζ/4-1BB lentiviral vector, expanded in vitro and then frozen for future administration.
15949899|NCT03265093|Other|Platelet Rich Fibrin Injection|Venous blood will be taken from the patient every session and I-PRF will be created in the centrifuge. I- prf will be injected on one side and corticosteroid will be injected on the other side in patients with bilateral oral lichen planus. Once a week in the first month after treatment and one time at the end of the second month, the patient will be called to the control.
15949900|NCT03265093|Drug|Corticosteroid|Corticosteroid injection
15949901|NCT03265080|Biological|ADXS-NEO|Biopsy, blood draws, CT scans, trial product administration
15949902|NCT03265067|Device|autoRIC|Application of the autoRIC device
15949903|NCT03265054|Biological|Analysis of plasma samples|Measuring microparticles (MPs) in Human Plasma Samples
15949904|NCT03265041|Diagnostic Test|multi-slice CT coronary angiography and coronary angiography|multi-slice CT coronary angiography to evaluate graft number and patency validated by coronary angiography
15949905|NCT03265028|Behavioral|TRACE e-learning|The TRACE e-learning (www.acutecough.org) is an educational web-based module including communication training for physicians, and includes patient booklets to be used interactively during the consultation.
15949906|NCT03265015|Behavioral|Habit Override Practice|"Computerized brain training to provide practice in overriding avoidance habits."
15949907|NCT03265015|Other|Transcranial Magnetic Stimulation|Non-invasive method for temporary, focal stimulation of brain areas.
15949908|NCT03265002|Dietary Supplement|Placebo|Ingestion of 500ml water with 50ml lemon juice and 20g dextrose
15949909|NCT03265002|Dietary Supplement|Inulin|Ingestion of 500ml water with 50ml lemon juice and 20g inulin
15949910|NCT03265002|Dietary Supplement|Psyllium|Ingestion of 500ml water with 50ml lemon juice and 20g psyllium
15949911|NCT03265002|Dietary Supplement|Inulin and psyllium|Ingestion of 500ml water with 50ml lemon juice and 20g inulin and 20g psyllium
15949912|NCT03264989|Drug|crizanlizumab|SEG101 (crizanlizumab) drug at a dose of 5.0 mg/kg (or 7.5 mg/kg for exploratory group) by IV infusion
15949913|NCT03264976|Diagnostic Test|hematological examination, ophthalmic examination|Hematological examination includes biochemical examination, routine coagulation test, HbA1c, C reactive protein (CRP)；Ophthalmic examination includes the basic situation and clinical diagnosis of eyes, ETDRS visual acuity chart score, intraocular pressure, OCT examination, OCTA examination, fundus photos, Optos wide angle fundus imaging.
15949914|NCT03264963|Other|Smart phone game play|Voice controlled smart phone game play 15 minutes daily and recording sounds of sleep environment 2 night per week for 12 weeks
15949915|NCT03264963|Other|Control|Recording of sleep environment 2 nights per week for 12 weeks
15949916|NCT03264950|Diagnostic Test|Elastography|"an ultrasound exam after selecting the best acoustic window, a region of interest (ROI) is placed in an area of the liver perpendicular to the liver capsule, taking care not to include large vasculature or biliary structures.
~Similarly an acoustic window will be selected for the pancreas as well"
15949917|NCT03264937|Behavioral|Social-software management|Using Wechat application, a social platform, to manage warfarin therapy in patients with mechanical valve replacement.
15949918|NCT03264924|Behavioral|IPAIR|Motivational interview training
15949919|NCT03264911|Drug|Amoxicillin or Placebo|Children will be randomized to either 6 days of amoxicilline or 6 days of placebo treatment
15949920|NCT03264898|Device|Fecal immunochemical test (FIT)|FIT is a type of fecal occult blood test that uses antibodies to hemoglobin to detect blood in stool.
15949921|NCT03264885|Other|Incentive Care|ICS is a novel intervention that incorporates patient education, social support, and financial assistance to assist individuals.
15949922|NCT03264872|Behavioral|Peer-Enhanced Motivational Interviewing|Target clients in this Peer-Enhanced Motivational Interviewing arm will receive separate one-hour Motivational Interviewing (MI) sessions, in which the therapist reviews the target clients substance use behaviors in a non-confrontational manner, listens empathetically, and reinforces any client statements indicating a desire the change. In this arm, the therapist also presents the target client's peer with data about the extent of the target client's substance use, builds the peer's motivation to help their friend, and teaches the peer communication sills they can use to influence the target client's substance use behaviors.
15949923|NCT03264872|Other|Waitlist Control|After the 12 week follow up period, if subjects in the Waitlist Control group desire to receive the Peer-Enhanced Motivational Interviewing intervention, that will be made available to them.
15949924|NCT03264859|Diagnostic Test|NGAL levels early and post STEMI|NGAL levels early and post ST elevation MI (STEMI)
15949925|NCT03264846|Diagnostic Test|Collection of Serum and Saliva Samples|Whole saliva samples were obtained via expectorating into polypropylene tubes venous blood were obtained from the antecubital vein via the standard venipuncture method.
15949926|NCT03264833|Other|TempTraq|no intervention
15949927|NCT03264820|Device|Laser Doppler|- Laser measurements at the level of each finger at 47 °C and at ambient temperature
15949928|NCT03264820|Device|Laser speckle|- Laser measurements at the forearm
15949929|NCT03264820|Behavioral|pain evaluation|Visual scale assesment pain
15949930|NCT03264820|Other|Blood pressure and heart rate|Measurement of blood pressure and heart rate
15949931|NCT03264807|Procedure|D2 lymphadenectomy|Subtotal gastrectomy with D2 lymphadenectomy (lymph node #1, #3, #4sb, #4d, #5, #6, #7, #8a, #9, #11p, #12a) is conventional surgery in patients with advanced gastric cancer such as T3N+ or T4N+ stage.
15949932|NCT03264807|Procedure|D2 and #14v lymphadenectomy|Subtotal gastrectomy with D2 (lymph node #1, #3, #4sb, #4d, #5, #6, #7, #8a, #9, #11p, #12a) and #14v lymphadenectomy is experimental surgery in patients with advanced gastric cancer such as T3N+ or T4N+ stage.
15949933|NCT03264794|Drug|Gefitinib Tab （CTTQ），First medication；Gefitinib Tab （CTTQ），From the 8th day of trial|Gefitinib Tab （CTTQ），First medication,250mg；
15949934|NCT03264794|Drug|Gefitinib tablets (Yi Ruisha），First medication|Gefitinib tablets (Yi Ruisha），First medication,250mg；
15949935|NCT03264794|Drug|Gefitinib Tab 250 MG（CTTQ），From the 8th day of trial.|From the 8th day of the experiment, two groups of subjects were treated with Gefitinib（CTTQ）
15949937|NCT03264768|Device|endobronchial valves|A ambulatory diagnostic bronchoscopy under general anesthesia will evaluate the presence or absence of collateral ventilation . The targeted lobar airway is temporarily occluded by means of a balloon catheter, which blocks inspiratory flow but allows expiratory flow, in order to assess whether the air flow gradually declines to zero, meaning absence of collateral ventilation. Only in case collateral ventilation is excluded, a therapeutic bronchoscopy will be scheduled to insert the one-directional endobronchial valves in the targeted lobar airways. We will only perform a unilateral intervention during which we will treat one or maximal two lobes at one side.
15949938|NCT03264768|Behavioral|physical activity tele coaching|3 month physical activity tele coaching intervention consisting of a project tailored smartphone application in combination with a step counter providing direct feedback.
15949939|NCT03264768|Procedure|Lung volume reduction surgery (LVRS)|Patients not eligible for endoscopic lung volume reduction (or non responders of this intervention) can be referred for surgical lung volume reduction. With this procedure, the most emphysematous parts of the lungs will be surgically removed.
15949940|NCT03264755|Device|Repetitive transcranial magnetic stimulation|Repetitive transcranial magnetic stimulation for cortical excitability in smokers and non smokers
15949941|NCT03264742|Other|Ghrelin|The patients are assigned within the scope of the admission according to emergency to the treatment and clarification on the Stroke Unit of the KSW. There the patients are enclosed in the study and are examined according to the draught on the Stroke Unit within the scope of the complex treatment. The inclusion of the patients occurs after clarification and in the consent of the patients. In the morning after the admission day the decrease of the first blood test occurs within the scope of the blood sample as a matter of routine to be carried out for the Ghrelinbestimmung. Also 48 H occurs after the first withdrawal and 3 months after the stroke a blood sample to the regulation of Ghrelin.
15949942|NCT03264729|Other|Isometric exercise|The isometric exercise is performed standing with the forefoot on a step. The participant is instructed to stand still with the ankle joint in neutral and hold this position. Supporting oneself for balance by placing the hands on a wall or a rail is allowed. The participant performs 5 sets of 45-second isometric holds. The load used is the heaviest possible load that the participant is able to withstand for 1 minute. As with the isotonic exercise, if the participant's body weight is inadequate the participant is fitted with a backpack with books and/or weights.
15949943|NCT03264729|Other|Isotonic exercise|"The isotonic exercise is performed standing with the forefoot on a step. The toes are maximally dorsi-flexed by placing a towel underneath them. The participant is instructed to perform a heel-raise to a maximal plantar flexion in the ankle joint, and afterwards to lower the heel to maximal dorsi flexion. Supporting oneself for balance by placing the hands on a wall or a rail is allowed. The participant performs 4 sets of 8 repetitions with a load of 8RM. The contraction time is 3s concentric, 2s isometric and 3s eccentric and will be guided by a metronome.
~If the participant's body weight is inadequate to reach sufficient loading during the exercises the participant is fitted with a backpack with books and/or weights."
15949944|NCT03264729|Other|Walking|The walking will be performed barefoot and the participant will be instructed in walking at a pace similar to the pace they would use when walking around in their home. The duration of the walking session will be four minutes to match the duration during the exercises.
15949945|NCT03264716|Device|HepaSphere TACE (transarterial chemoembolization)|100 mg doxorubicin will be loaded onto the HepaSphere Microspheres and delivered via microcatheter.
15949946|NCT03264677|Combination Product|Group 1|NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Kiwi Water Gel
15949947|NCT03264677|Combination Product|Group 2|NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Water Gel
15949948|NCT03264677|Combination Product|Group 3|NTG Hydro Boost Gelee Milk Cleanser + NTG Hydro Boost Extra Dry Emulsion
15949951|NCT03264651|Drug|enobosarm|Oral combination therapy of enobosarm and anastrozole
15949952|NCT03264638|Drug|Dingkundan|Dingkundan 7g capsule by mouth, twice daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles
15949953|NCT03264638|Drug|Dingkundan & Diane-35|Dingkundan 7g capsule by mouth, twice daily, and Diane-35 one pill by mouth, once daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles
15949954|NCT03264638|Drug|Diane-35|Diane-35 one pill by mouth,once daily, beginning on Day 5 of menstrual cycle for 21 consecutive days followed by a 7-day interval without medication; for three cycles
15949955|NCT03264625|Drug|Cholecalciferol (2000iu qd)|Patients will receive oral Cholecalciferol (2000IU qd) apart from routine therapy for PD
15949956|NCT03264625|Other|Routine therapy for PD|Patients randomized to the placebo group will receive routine therapy for PD.
15949957|NCT03264612|Behavioral|Aerobic exercise|"Females in group I were instructed to engage into swimming exercise 30 minutes daily, 3 times weekly for 3 months. Exercise was ceased on the first 3 days of menstrual cycle then resumed afterwards.
~The exercise included three stages: warming up, swimming and cooling down."
15949958|NCT03264599|Device|transabdominal ultrasound|2D trans abdominal ultrasound was done during the first stage of labor. If fetal position is occiput anterior and fetal presentation is vertex, two dimensional sagittal picture of the fetal head and upper spine was acquired and stored in the ultrasound machine. On this image, the offline measurement of the angle formed by a line tangential to the occipital bone and a line tangential to the first vertebral body of the cervical spine (occiput-spine angle) will be performed to quantify the degree of fetal head flexion in respect to the trunk
15949959|NCT03264586|Drug|Lidocaine-prilocaine cream|"5gm dose of cream applied to the intact surface of the perineum and area covered with an occlusive dressing to facilitate penetration
~- EMLA cream was applied, 1 hour before the expected time of birth."
15949960|NCT03264586|Drug|mepivacaine infiltration group|"10 ml of 1% mepivacaine solution was injected slowly when the fetal head was crowned with frequent aspiration to avoid intravascular injection.
~In the mepivacaine group, if an episiotomy was indicated, it was performed after infiltration of perineal tissue with 10 ml of 1% mepivacaine solution.
~The suture procedure was delayed 10 minutes after the injection of the aneathetic"
15949999|NCT03264287|Procedure|1 time per week therapeutic frequency|Participants will receive acupuncture, moving cupping and ear-tapping procedure 1 time per week over the 6 weeks period.
15950000|NCT03264274|Drug|Aflibercept|Antiangiogenic
15949961|NCT03264586|Procedure|mediolateral episiotomy|"Episiotomy repair a loose, continous, non locking suture to close the vaginal mucosa and the muscular layer of the perineum using vicryl Number zero (0).
~At the end of the vaginal mucosal repair care is taken to align the edges of the episiotomy wound
~At the point where perineal skin begins; the suture is then passed beneath the vaginal mucosa, and repair of perineal muscle begins. The deep layer of muscles is closed first, ensuring no dead space one left behind
~The skin was closed with the same continuous suture to approximate the subcutinuous tissue."
15949962|NCT03264573|Biological|Stem cell|after scar revision PRP is injected intradermally, also adipose derived mesenchymal stem cells
15949963|NCT03264573|Device|MSCs|manual separation of platelets rich plasma and undifferentiated mesenchymal stem cells
15949964|NCT03264560|Behavioral|Telepsychiatry|A total of 6 synchronous or asynchronous telepsychiatry interventions conducted via telecommunications done at baseline, 1 month, 2 months, 3 months, 6 months, and 12 months.
15949965|NCT03264547|Drug|Pertuzumab|Every 3 weeks
15949966|NCT03264547|Drug|Trastuzumab|Every 3 weeks
15949967|NCT03264547|Drug|Docetaxel|Every 3 weeks
15949968|NCT03264547|Drug|Paclitaxel|Every week
15949969|NCT03264547|Drug|Eribulin|Administered for 2 weeks and is then stopped to be administered for 1 week
15949970|NCT03264534|Procedure|limbal relaxing incisions|Manually performed surgical procedure
15949971|NCT03264534|Procedure|astigmatic keratotomy|femtosecond laser guided surgical procedure
15949972|NCT03264521|Other|Surveys|Web surveys about experiences with chronic low back pain, demographics, coding qualitative text.
15949975|NCT03264495|Other|Weight the food served minus the left-overs|
15949976|NCT03264482|Procedure|M-TURP|endoscopic resection of the prostatic adenoma
15949977|NCT03264482|Procedure|THUVAP|vaporization of prostatic adenoma via THULIUM laser
15949978|NCT03264456|Diagnostic Test|[18F] Fluciclovine PET/MRI|[18F] fluciclovine PET/MRI
15949979|NCT03264456|Drug|[18F] fluciclovine|[18F] fluciclovine
15949980|NCT03264443|Behavioral|Health education|Weekly group lectures (1h each) giving information on patient's best practices to manage hypertension.
15949981|NCT03264443|Behavioral|Combined training|Combined training (aerobic and strength exercises), in moderate intensities (perceived exertion controlled) performed 3x/week (1h) duration with a education component (10') based on the contents of the health intervention.
15949982|NCT03264430|Drug|Ketamine|an antagonist of the NMDA receptor
15949983|NCT03264430|Drug|bupivacaine|local anaesthetic
15949986|NCT03264378|Behavioral|Physical Exercise Intervention|The 12-week physical exercise intervention will be delivered by trained community health workers (CHW) who are supervised by nurses. The CHW will visit the patient's home-3 sessions per week for the first 2 weeks, followed by weekly visits for 6 weeks, and then weekly telephone support for 4 weeks-to instruct the family caregiver and the patient in the exercise routine. Each session includes physical activities designed to promote gentle stretching, strength, balance, flexibility, and endurance, with a progressive schedule (i.e., the total length of time increases from 10 minutes up to 30 minutes maximum) and its intensity adjusted based on the participant's level of fitness.
15949987|NCT03264365|Behavioral|Intervention|"Intervention (plus standard care)
~Patients photographs during the ICU-stay,
~Written information about life after ICU
~First consultation face-to-face in hospital setting at three months after ICU
~Visit ICU and photographs given
~Consultations as needed"
15949988|NCT03264352|Drug|Allisartan Isoproxil|Allisartan Isoproxil 240mg daily will be used to lower BP to below 120 mm Hg systolic.
15949989|NCT03264352|Drug|Amlodipine 5mg|Amlodipine 5mg daily will be added to Allisartan Isoproxil and afterwards increased to 10mg daily, if necessary to reach the blood pressure goal (below 120 mm Hg systolic).
15949990|NCT03264352|Other|Standard treatment by current guideline|No BP-lowering medications are used until BP becomes ≥ 140 mm Hg systolic and/or 90 mm Hg diastolic. Medications are determined by investigators in lines with recommendations by current Chinese guidelines to decrease BP to lower than 140 mm Hg systolic and to lower than 90 mm Hg diastolic.
15949991|NCT03264339|Behavioral|Small Step Program|The Small Step intervention program has three alternating treatment foci (Hand use, Mobility, Communication) divided into five different steps, each lasting for 6 weeks (in total 30 weeks).
15949992|NCT03264326|Other|Blood Flow Restriction Training|Delfi Personalized Tourniquet System occludes 80% venous pressure during lower extremity exercise.
15949993|NCT03264326|Other|Sham Blood Flow Restriction Training|Delfi Personalized Tourniquet System occlude 20 mmHG venous pressure during lower extremity exercise as a sham treatment.
15949994|NCT03264326|Other|Eccentric Exercise|Subjects perform eccentric calf lowering off a step for 90 repetitions twice daily.
15949995|NCT03264313|Device|Deep Transcranial Magnetic Stimulation|Patients undergoing of Deep Transcranial Magnetic Mtimulation (dTMS) for smoking cessation
15949996|NCT03264300|Other|MRI|MRI scans to include: scout images, transmitter tuning, shimming, slice prescription - 5 min; conventional structural MRI; T1-weighted anatomic MRI scan - 7 min; and, T2-weighted anatomic MRI scan - 5 min. Advanced MRI to include: Diffusion Weighted MRI (DW-MRI) - 7 min; Chemical Exchange Saturation Transfer (CEST) - 9 min; Dynamic Susceptibility Contrast / Dynamic Contrast Enhanced MRI - 8 min; and, other advanced imaging, as needed, to be determined. Post-contrast conventional MRI to include T1-weighted anatomic MRI scan - 7 min. Repeat within 1 month.
15949997|NCT03264300|Other|MRI|MRI scans to include: scout images, transmitter tuning, shimming, slice prescription - 5 min. Conventional structural MRI to include: T1-weighted anatomic MRI scan - 7 min; and, T2-weighted anatomic MRI scan - 5 min. Serial DSC-MRI: staged injections of Gd-based contrast and Ferumoxytol - 20 min. Post-contrast conventional MRI: T1-weighted anatomic MRI scan - 7 min.
15949998|NCT03264287|Procedure|3 times per week therapeutic frequency|Participants will receive acupuncture, moving cupping and ear-tapping procedure 3 times per week over the 6 weeks period.
15950001|NCT03264274|Procedure|Dynamic Contrast Enhanced Ultrasound|DCE-US (a technique using differential liver blood flow assessments using microbubble) will be performed at baseline, Week 2 and 8 of treatment.
15950002|NCT03264261|Device|robotic training|robotic training, 3 times/week for 6 weeks
15950003|NCT03264261|Device|treadmill training|treadmill training only, 3 times/week for 6 weeks
15950004|NCT03264248|Device|E-Scale|Daily bodyweight system used under legs of bed
15950005|NCT03264235|Device|Keeogo|"Keeogo is a computer-controlled lower extremity motorized orthosis worn over the user's hips and legs. The controller box contains sensors that supply information about the kinematics and the kinetics of the user's lower extremities and includes software that recognizes the user's mobility intentions. The system is powered by a lithium-polymer battery. The leg brace assembly is mainly comprised of the actuator, the electronic boards, hip joint, and soft goods (cuffs, belts) for affixing the assembly to the user's legs. The waist belt comes in various sizes adapted to each wearer, and adds additional support of the device on the user.
~Keeogo does not initiate any movement but waits for the user's lead. Once the user makes the first move, Keeogo assists according to the activity. The individual must be able to initiate and terminate steps."
15950006|NCT03264235|Other|Traditional Stair Training|Individuals will participate in traditional stair training physical therapy for the same duration of time as Group 1.
15950007|NCT03264222|Other|Security screening procedure|Screening procedure with security device (model QPS 100)
15950008|NCT03264209|Behavioral|Smart After-Care (Mobile health)|Patients in intervention group will be provided with Smart After-Care Service including intervention for physical activity (aerobic exercise at least 90 or 150 minutes every week for 12 weeks depending on patients' aerobic fitness by monitoring with smartband and strengthening exercise at least 2 times a week for 12 weeks), information for prostate cancer and adequate life style, and smartband that can connect to the smartphone. Case management consists confirmation of hospital visit date, checking the adverse effect and treatment compliance.
15950009|NCT03264196|Procedure|Open Reduction and Internal Fixation|Surgical treatment of fracture
15950010|NCT03264183|Diagnostic Test|Transesophageal Echocardiography|TEE measures of right ventricular function
15950011|NCT03264183|Diagnostic Test|Transthoracic Echocardiography|TTE measures of right ventricular function
15950012|NCT03264170|Diagnostic Test|Prediction of pregnancy outcome|The intervention group will receive the individualised prediction of their pregnancy (as a percentage). The prediction is calculated by a validated, accurate mathematical model using specific background information and ultrasound data for each participant.
15950013|NCT03264157|Drug|HRIG|A 20 IU/kg dose of BPL HRIG will be given on Day 0 via IM injection.
15950014|NCT03264157|Drug|HyperRAB|A 20 IU/kg dose of Comparator HRIG will be given on Day 0 via IM injection.
15950015|NCT03264157|Biological|RabAvert|A 1.0 ml dose of active vaccine (2.5 IU/ml) will be given IM on 5 occasions: on Days 0, 3, 7, 14, and 28.
15950016|NCT03264144|Behavioral|Social norms campaign|Intervention messages will mainly highlight the prevalence of Hong Kong adolescents who do not smoke cigarettes and have no intention to smoke cigarettes. The messages will be conveyed to students through posters, table tents, flyers and an online banner. Posters will be posted at prominent places in schools, table tents will be placed in school canteens, flyers will be distributed to students, and the online banner will be placed at the school website. The intervention will last for 2 months.
15950017|NCT03264131|Drug|Brentuximab Vedotin|Brentuximab Vedotin will be given at 1.8 mg/kg IV over approximately 30 minutes on D1 every 21 days for 2-6 cycles. Responders (CR, PR or SD) who are not eligible for bone marrow transplant (BMT) and have CD30-positive ATLL will continue maintenance therapy with BV alone (1.8 mg/kg IV for approximately 30 minutes, every 21 days).
15950018|NCT03264131|Drug|CHEP|"Cyclophosphamide- 750 mg/m^2 IV over approximately 1 hour on D1 every 21 days for 2-6 cycles
~Doxorubicin- 50 mg/m^2 IV over approximately 3-5 minutes on D1 every 21 days for 2-6 cycles.
~Etoposide - 100 mg/m^2 IV over approximately 1 hour each day for 3 days every 21 days for 2-6 cycles.
~Prednisone - 100 mg, orally once daily for 5 days every 21 days for 2-6 cycles."
15950019|NCT03264118|Procedure|Scaling and root planing|Furcation treatment by scaling and root planing
15950020|NCT03264118|Drug|Toluidine Blue O|Antimicrobial photodynamic therapy with toluidine blue O (10mg/ml) and red laser.
15950021|NCT03264105|Other|Hydroxyapatite Nanofiber reinforced flowable composite|retention rate evaluation of Hydroxyapatite Nanofiber reinforced flowable composite
15950022|NCT03264105|Other|conventional resin-based flowable composite|retention rate evaluation of conventional resin-based flowable composite
15950023|NCT03264092|Procedure|Endoscopic ultrasound guided fine needle biopsy|Using the echoendoscope the lesion is identified and the needle is inserted in it to obtain a biopsy also under sonographic guidance
15950024|NCT03264079|Drug|Bardoxolone methyl capsules 10 mg|One 10 mg capsule of bardoxolone methyl administered on Study Day 1 (Period 1) of the trial and one 10 mg capsule of bardoxolone methyl administered on Study Day 18 (Period 2) of the trial
15950025|NCT03264079|Drug|Itraconazole capsules 100 mg|Two 100 mg capsules of itraconazole administered once daily during Study Days 15 - 27 (Period 2) of the trial
15950026|NCT03264066|Drug|Cobimetinib|Participants will receive cobimetinib 60 mg (3 tablets of 20 mg each) orally once a day on Days 1-21 of each 28-day cycle.
15950027|NCT03264066|Drug|Atezolizumab|Atezolizumab will be given at a fixed dose of 840 mg by intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle.
15950028|NCT03264066|Drug|Atezolizumab Cohort 7|Only for participants in cohort 7, the first dose of atezolizumab of 840 mg will be given by IV infusion on Day 15 of Cycle 1; thereafter, they will receive atezolizumab 840 mg IV infusion Q2W on Days 1 and 15 of Cycle 2 and all subsequent cycles.
15950029|NCT03264053|Device|Socket shield|Socket shield is the Removal of the lingual portion of the anterior root thus retaining the lingual portion
15950030|NCT03264053|Procedure|Conventional immediate implantation|Conventional immediate implantation
15950031|NCT03264027|Drug|Carbon dioxide|Carbon dioxide will be used as an insufflating gas during argon fulguration of the dilatated anastomosis.
15950032|NCT03264027|Drug|Ambient air|Ambient air will be used as an insufflating gas during argon fulguration of the dilatated anastomosis.
15950145|NCT03263260|Device|implant|coronary stent implantation
15950146|NCT03263247|Behavioral|Memory Training|
15950147|NCT03263247|Behavioral|Psychoeducation|
15950148|NCT03263247|Behavioral|Alphabet search|
15950033|NCT03264027|Drug|Argon fulguration|The dilatated anastomosis from the gastric bypass surgery will be reduced in diameter using fulguration with argon. Patient in both groups will be placed in the left lateral decubitus position, with anesthesia being performed exclusively using propofol; adequate cardiopulmonary monitoring will be carried out during the entire procedure. After sedation, endoscopy will be performed with an Olympus CV-180 endoscope (Olympus, Tokyo, Japan) and analysis and measurement of the anastomosis will be achieved using Raptor foreign body forceps (Endoscopy Group US, Inc., Mentor - Ohio, USA). The images will be transferred to an Olympus EvisExera II processor connected to a computer with the ZScan 5 program (Goiânia, GO, Brazil).
15950034|NCT03264001|Behavioral|Negative energy balance|20% and 40% reduction of daily energy needs for weight maintenance
15950035|NCT03263988|Device|ConCardiac|All patients receive a piezocapacitative-interlayer-technology hemodynamic measurement by ConCardiac device (SectorCon GmbH, Berlin, Germany).
15950036|NCT03263975|Other|Gatorade or Enterade|Commercially available oral rehydration therapies
15950037|NCT03263962|Drug|Canrenone|Evaluation of canrenone therapy in patients with CHF
15950038|NCT03263949|Other|Diagnostic|For the analysis of myocardial function, conventional 2D echocardiography and tissue doppler will be used. For the evaluation of myocardial mechanics, 2D speckle tracking, strain, strain rate and mechanical dispersion will be obtained.
15950039|NCT03263936|Drug|Decitabine|Dose Level #0: 5 mg/m2 Dose Level #1: 7.5 mg/m2 Dose Level #2: 10 mg/m2 Dose Level #3: 15 mg/m2 Dose Level #4: 20 mg/m2 given IV over __ hour on days 1 through 5
15950040|NCT03263936|Drug|Vorinostat|Age <18: 180 mg/m2/day once daily PO. Age≥18: 200 mg twice daily PO.
15950041|NCT03263936|Drug|Filgrastim (G-CSF)|Given on days 5 until evidence of ANC recovery (>500/µL)5µg/kg/dose IV or SQ (starting at hour 0)
15950042|NCT03263936|Drug|Fludarabine|30 mg/m2/day IV over 30 minutes (starting at Hour 0 - Immediately after G-CSF)
15950043|NCT03263936|Drug|Cytarabine|2000 mg/m2/day (Starting at Hour 0.5),IV over 3 hours, days 6-10
15950044|NCT03263923|Behavioral|Cognitive behavioral intervention and journaling|Cognitive behavioral skills training and 4 weeks of online journaling
15950045|NCT03263923|Behavioral|Reflective journaling|"Reflective journaling training and 4 weeks of online journaling
~Training in reflective journaling and 4 weeks of online journaling"
15950046|NCT03263910|Drug|NPO-11|20 ml NPO-11
15950047|NCT03263910|Drug|Placebo|20 ml NPO-11(Placebo)
15950048|NCT03263897|Device|insufflation|mobile interface driven insufflation of the ear canal
15950049|NCT03263897|Device|placebo insufflation|mobile interface driven placebo insufflation of the ear canal
15950050|NCT03263884|Device|Repetitive trancranial magnetic stimulation (rTMS) group|Repetitive trancranial magnetic stimulation is applied on the dorsolateral prefrontal cortex. The protocol consists on 20 minutes of 10Hz stimulation, 5 seconds on, 10 seconds off, at 110% RMT, for a total of 4000 pulses.
15950051|NCT03263884|Device|Sham group|A sham coil is used to mimic the clicking sound of the trancranial magnetic coil and skin stimulation.
15950052|NCT03263871|Dietary Supplement|PTM202|PTM202 given twice daily for 30 days.
15950053|NCT03263871|Dietary Supplement|micro-nutrient sprinkles|Micro-nutrient sprinkles will be given twice daily for 30 days.
15950054|NCT03263858|Device|Stent|Implantation of coronary stent in de novo coronary artery lesions
15950055|NCT03263832|Diagnostic Test|Antibiofilmogramme|An Antibiofilmogramme (BioFilm Control) evaluates the capacity of a series of antibiotics to inhibit the growth of bacterial biofilms for a given bacterial isolate.
15950056|NCT03263819|Diagnostic Test|Oral glucose tolerance test|75 grams of glucose
15950057|NCT03263806|Diagnostic Test|CTFFR-Guided Group Management|Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results will be communicated to the provider who will use CTFFR interpretation to guide care pathway.
15950058|NCT03263806|Diagnostic Test|SOC Group Management|Patients will receive standard of care CT on enrollment which will be analyzed by CTFFR. Results are NOT communicated to the provider who will dictate patient management according to their own clinical judgment
15950059|NCT03263793|Behavioral|Choral (group) singing therapy sessions|Choral (group) singing therapy sessions will be conducted once weekly and daily home practice exercises will be assigned. All vocal exercises are based on principles that have been successful in other intensive Parkinson Disease vocal exercise programs.
15950060|NCT03263780|Drug|18F-Fluciclovine|Imaging (comparing standard and experimental high resolution diffusion-weighted imaging [DWI] MRI with 18F-Fluciclovine)
15950061|NCT03263767|Drug|Fludarabine|30 mg/m² Intravenous 5 days from Day-6 to Day-2
15950062|NCT03263767|Drug|Clofarabine|30 mg/m² Intravenous 5 days from Day-6 to Day-2
15950063|NCT03263767|Radiation|Full body irradiation|2 grays at Day-1
15950064|NCT03263767|Drug|Cyclophosphamide|14 mg/kg intravenous 2 days at Day - 6 and day -5
15950065|NCT03263767|Drug|Cyclophosphamide|50 mg/kg intravenous 2 days at day +3 and day +4
15950066|NCT03263767|Other|stem cell transplantation|at D0 intraveinous Depending on donor : the stem cells will be extracted from blood (CD34+) or from bone marrow (CD34+ and nuclear cells)
15950067|NCT03263767|Other|nuclear cells|CD3+ cells if needed after transplantation
15950068|NCT03263767|Drug|Thymoglobulin Injectable Product|At day -2 2.5 mg/kg for patients inclued after 14 dec 2020
15950069|NCT03263754|Behavioral|Pocket Medic|10 short digital films utilising self-determination theory aiming to increase patient self-management
15950070|NCT03263754|Behavioral|Pulmonary Rehabilitation|PR follows National Institute for Clinical Excellence guidelines delivering 14 sessions over 7 weeks utilising a multidisciplinary approach
15950071|NCT03263741|Drug|Paclitaxel + S-1 + Oxaliplatin|"Paclitaxel: 135 mg/m2, iv, 3h, at D1. S-1: S-1: 40mg twice daily for patients with a body surface area (BSA) < 1.25 m2, 50mg twice daily for patients with a BSA of 1.25 m2 to < 1.5 m2, 60mg twice daily for patients with a BSA of ≥ 1.5 m2 for two weeks, and then suspend for one week.
~Oxaliplatin: 85 mg/m2, iv, 2h, at D1."
15950072|NCT03263728|Diagnostic Test|Cardiac Magnetic Resonance|Screening of asymptomatic of high risk type 2 diabetic mellitus patients with stress cardiac magnetic resonance
15950073|NCT03263715|Drug|Tocilizumab Prefilled Syringe [Actemra]|Weekly administration of Tocilizumab 162 mg subcutaneous from Baseline to Week 16.
15950074|NCT03263715|Drug|Placebos|Weekly administration of Placebo subcutaneous from Baseline to Week 16.
15950075|NCT03263715|Drug|Glucocorticoids|Rapidly tapered Glucocorticoid treatment. 20 mg/day of prednisone at randomization and a pre-specified taper regimen will be followed over 11 weeks: Week 0: 20 mg Week 1: 17,5 mg Week 2: 15 mg Week 3: 12,5 mg Week 4: 10 mg Week 5: 9 mg Week 6: 7 mg Week 7: 5 mg Week 8: 4 mg Week 9: 2 mg Week 10: 1 mg Week 11: 0 mg
15950076|NCT03263702|Device|Computational Mapping Algorithm|This software enables high resolution temporospatial mapping of atria for the identification of drivers of AF. CMA receives data from standard of care, commercially available 3D Mapping Systems (St. Jude Ensite System) and catheters and processes the data in a unique way. Electrogram and anatomy data are fed from the commercially available 3D Mapping System to an adjacent laptop computer, via an Ethernet connection, that is running CMA. CMA then processes the electrogram data and generates a map of where the potential AF driver domains are located and superimposes those potential AF driver domain targets onto the 3D geometry of the anatomy (provided by the 3D mapping system).
15950077|NCT03263689|Drug|Intrathecal morphine|ITM group were given 100 micrograms of preservative-free morphine in addition to the local anaesthesia (plain hyperbaric bupivacaine 10mgs) intrathecally during the spinal anaesthesia
15950078|NCT03263676|Device|Icon resuable underwear|Reusable incontinence underwear
15950079|NCT03263676|Device|Disposable pad|Standard market disposable pad
15950080|NCT03263663|Drug|targeted substance according to the avatar model|individualized second line treatment
15950081|NCT03263650|Drug|Cabazitaxel|25mg/m2 administered intravenously over 60 minutes on day 1 of cycles 1-6; given before carboplatin.
15950082|NCT03263650|Drug|Carboplatin|AUC 4 administered intravenously over 60 minutes on day 1 of cycles 1-6
15950083|NCT03263650|Drug|Prednisone 5Mg|5 mg administered by mouth twice daily on days 1-21 of cycles 1-6.
15950084|NCT03263650|Drug|Olaparib|Administered by mouth twice daily at a dose of 300 mg by mouth twice daily, dispensed on Day 1 of cycle 7 to participants randomized to receive olaparib maintenance and every 21 days thereafter until the participant completes the study, withdraws from the study or the closure of the study.
15950086|NCT03263624|Device|fractional carbon dioxide laser|One hand of each patient will receive three sessions of fractional carbon dioxide laser at four- week interval.
15950087|NCT03263624|Drug|Tazarotene Cream 0.1%|tazarotene cream 0.1% once daily
15950088|NCT03263611|Drug|Placebo|single intradiscal injection
15950089|NCT03263611|Drug|AMG0103|single intradiscal injection
15950090|NCT03263585|Device|Spinal orthosis Spinomed|
15950091|NCT03263585|Other|Equipment training|
15950092|NCT03263572|Biological|Blinatumomab|Given IV
15950093|NCT03263572|Drug|Cytarabine|Given intrathecally via spinal tap
15950094|NCT03263572|Drug|Methotrexate|Given intrathecally via spinal tap
15950095|NCT03263572|Drug|Ponatinib|Given PO
15950104|NCT03263546|Behavioral|Internet-delivered cognitive behavioral therapy (ICBT)|"Participants will receive internet-delivered CBT with therapist support for 16 weeks. The treatment consists of 14 online chapters with interactive features as videos and illustrations. The treatment has the main focus on exposure with ritual prevention. The children and parents have regular contact with a personal assigned therapist via written text messages in the platform.
~Participants that are classified as non-responders at 3 months follow-up will receive face-to-face CBT of up to 12 sessions over 12 weeks."
15950105|NCT03263546|Behavioral|Cognitive behavioral therapy (CBT)|"Participants in the gold standard group will receive 14 individual face-to-face CBT sessions over 16 weeks. The treatment is based on current evidence based recommendations for OCD, and focuses on exposure with ritual prevention.
~Participants that are classified as non-responders at 3 months follow-up will receive additional face-to-face CBT of up to 12 sessions over 12 weeks."
15950106|NCT03263533|Drug|Vorinostat Oral Capsule Group 1|Following the initial washout and first 4-week period of the trial, all patients will enter a second 1-week washout. After the washout, all patients will then enter a second 4 week alternate treatment (vorinostat or placebo). During the vorinostat sequence, doses will be increased over the first 2 weeks in each phase of the crossover study, starting by 100 mg per day, and increasing to 200 mg by week 2 and 300 mg per day at the start of week 3 until the end of week 4.
15950107|NCT03263533|Drug|Vorinostat Oral Capsule Group 2|Following the initial washout and first 4-week period of the trial, all patients will enter a second 1-week washout. After the washout, all patients will then enter a second 4 week alternate treatment (vorinostat or placebo). During the vorinostat sequence, doses will be increased over the first 2 weeks in each phase of the crossover study, starting by 100 mg per day, and increasing to 200 mg by week 2 and 300 mg per day at the start of week 3 until the end of week 4.
15950108|NCT03263520|Drug|Nandrolone Decanoate|Drug administration
15950109|NCT03263520|Drug|Dexamethasone|Drug administration
15950110|NCT03263507|Drug|Placebo|Saline .9%
15950111|NCT03263507|Drug|IONIS-PKK-LRx|IONIS-PKK-LRx administered subcutaneously
15950112|NCT03263494|Device|Continuous Glucose Monitor (CGM)|Participants randomized to the CGM Group will receive a Dexcom CGM device and be instructed on how to utilize the CGM data in real time for diabetes management.
15950172|NCT03263039|Drug|Pembrolizumab|Pembrolizumab 200 mg Q3W
15950173|NCT03263026|Drug|Enzastaurin Hydrochloride|R-CHOP + Enzastaurin (Kinenza®) 125 mg
15950113|NCT03263481|Drug|Human Secretin for injection 16 mcg|Intravenous injection of human secretin for injection (16 mcg) will be administered over one minute. Pancreatic juice will be collected intraductally by continuous aspiration in 5-minute intervals for 30 minutes. Six samples will be collected at 5, 10, 15, 20, 25 and 30 minutes after secretin administration.
15950114|NCT03263468|Procedure|Same sitting PCI with complete revascularization|revascualrization of the non IRA (infarct related artery) of > 2.0 mm by coronary angioplasty/stenting at the time of primary PCI
15950115|NCT03263468|Procedure|Staged PCI with complete revsacularization >48 hours pf primary PCI|revascualrization of the non IRA (infarct related artery) of > 2.0 mm by coronary angioplasty/stenting >48 hours to 45 days post primary PCI
15950116|NCT03263455|Other|Kinesio taping group|"The tape in the KT group will be applied with paper-off tension, which means applying the tape directly to the skin as it comes off the paper backing (approximately with 15% to 25% of available tension). KinesioTape will be applied over the SCM dystonic muscle by means of 2 I-strips: the first strip will be placed on the medial (sternal) head and the second will be applied on the lateral (clavicular) head of the SCM muscle. KinesioTape was applied from the mastoid bone to the clavicle (rostrocaudal direction) with the SCM placed in a position of maximum stretching."
15950117|NCT03263455|Other|Sham Taping|"Patients in the ST group, smaller I-strips of KinesioTape will be used and they will be applied, with no tension and without stretching the muscles, perpendicularly to the muscle belly (starting from the middle and progressing to each side) over the same dystonic muscles as in the experimental group. Although the specific therapeutic elements of KinesioTaping (ie, longitudinal stretch, start and ending point tape application) will be removed"
15950120|NCT03263429|Drug|Glutaminase Inhibitor CB-839|Given by mouth
15950121|NCT03263429|Biological|Panitumumab|Given by vein
15950122|NCT03263429|Drug|Irinotecan Hydrochloride (phase I only)|Given by vein
15950123|NCT03263429|Other|Laboratory Biomarker Analysis|Correlative studies
15950124|NCT03263429|Other|Pharmacological Study|Correlative studies
15950125|NCT03263429|Device|Imaging with 11C-Glutamine PET/CT scans and 18F-FSPG PET/CT scans|During phase II at baseline and day 28 of cycle 1
15950126|NCT03263416|Other|Dedicated and coordinated follow-up|"Coordinated follow-up performed by a dedicated nurse with consultations (before treatment initiation and during treatment) and a telephone follow-up during treatment period
~Pharmaceutical conciliation before treatment initiation made by the Center Pharmacist
~Completion of QLQ-C30 and GIRERD questionnaires"
15950127|NCT03263416|Other|Standard follow-up|- Completion of QLQ-C30 and GIRERD questionnaires
15950128|NCT03263403|Biological|Ingovax ACWY|The pharmaceutical company in Bangladesh is now currently marketing meningococcal vaccine of Yuxi Walvax Biotechnology Co. Ltd which is filled finish by Incepta Vaccines Ltd. This fill finish meningococcal vaccine is already registered and licensed in Bangladesh. However, at present, no locally produced meningococcal vaccine is available in Bangladesh. Once this clinical trial is completed, it will then proceed for registration and licensure in Bangladesh. Ingovax ACWY is a freeze-dried preparation of the group-specific polysaccharide antigens from Neisseria meningitidis Group A, Group C, Group Y and Group W135. When reconstituted, the vaccine is a clear, colorless sterile solution for subcutaneous use.
15950129|NCT03263403|Biological|Quadri Meningo|Meningococcal polysaccharide vaccine Quadri Meningo vaccine manufactured by BiO-MeD Private Limited. Quadri Meningo [Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined] is a freeze-dried preparation of the Group-specific polysaccharide antigens from Neisseria meningitidis, Group A, Group C, Group Y, and Group W-135. After reconstitution with diluent, the vaccine is a clear colourless liquid.
15950130|NCT03263390|Procedure|Bariatric Surgery|Sleeve gastrectomy or Roux-en-Y Gastric Bypass
15950131|NCT03263390|Drug|Anti Obesity Drugs|Response to FDA approved anti obesity medications
15950132|NCT03263377|Dietary Supplement|The school feeding intervention|The baseline study will be conducted using a cluster randomized study design in which schools represent clusters. Seven schools will be randomly selected from each of 7 Upazilas out of 10 that have been selected for intervention. The school feeding intervention consists of a daily snack in the form of a fortified biscuit that provides 300 kcal per single 75 gm packet (approximately 15% of daily calorie requirements), and a range of micronutrients contributing to about 75% of the daily requirement of vitamin A, folate, iron, iodine, zinc and magnesium.
15950133|NCT03263351|Behavioral|Cognitive-behavioral therapy group|Psychoeducation on depression; cognitive restructuring of negative thoughts; engagement in pleasant activities; healthy rewards; stress and coping.
15950134|NCT03263351|Behavioral|Health education group|Didactic health knowledge about interpersonal violence; basic nutrition guidance; sun safety; depression and signs of suicide; gang violence; substance use.
15950135|NCT03263338|Behavioral|Mobile Sleep and Growth Study|The intervention is designed to test if sleep tips delivered by text messages can aid with reaching time in bed targets. And if additional motivational text messages can further aide with reaching time in bed targets.
15950136|NCT03263325|Other|Discarded urine sample|Collection of discarded urine during surgery and following surgery
15950137|NCT03263312|Behavioral|Exercise|Exercise training all patients enrolled.
15950138|NCT03263299|Drug|cabergoline|Cabergoline was administered in a dose of 1 mg/week in two divided doses which was terminated after embryo transfer
15950139|NCT03263299|Drug|Aspirin|Aspirin was administered in daily dose of 80 mg initiated at the start of down-regulation with luteal leuprolide
15950140|NCT03263299|Drug|GnRH agonist|Microdose flare-up regimen. The patient received diluted doses of the GnRH agonist leuprolide acetate 40 µg, given subcutaneously twice daily. Two days later, stimulation is initiated by intramuscular (IM) injections of HMG (Merional, IBSA, Germany) in a dose of 300 IU/day.
15950141|NCT03263286|Device|HandSOME|Participants use the HandSOME orthosis daily for 8 weeks.
15950142|NCT03263273|Drug|1% Topical Minocycline Gel|Treating Papulopustular Rosacea while monitoring for safety and efficacy of the active intervention
15950143|NCT03263273|Drug|3% Topical Minocycline Gel|Treating Papulopustular Rosacea while monitoring for safety and efficacy of the active intervention
15950144|NCT03263273|Other|Topical Vehicle Gel|Treating Papulopustular Rosacea while monitoring for safety and efficacy of the vehicle intervention
15950149|NCT03263234|Other|8 weeks of circadian adjusted LED-based lighting (CALED)|The luminaires are installed before the beginning of either the control or the intervention period. During the control period (8 weeks) the luminaires have normal light. During the intervention period (8 weeks) the luminaires have CALED. Cromaviso will calibrate CALED to mimic circadian rhythm according to the latest knowledge about the light phase-response curve for elderly.
15950150|NCT03263221|Procedure|reduction and fixation|Surgical procedures, as plating, Proximal Femoral Nail , Dynemic Hip screw and others procedures according to needed for each types
15950151|NCT03263208|Drug|Cyclophosphamide|patients will receive a standard pre-conditioning regime with cyclophosphamide 0.6-0.8g/m2/day IV for 2 days(Day-5 to day-4).
15950152|NCT03263208|Drug|Fludarabine|Fludarabine 25-30mg/m2/day IV for 3 days(Day-5 to day-3).
15950153|NCT03263208|Biological|CD19 CAR-T|CD19 CAR-T cells will be administered after completion of the chemotherapy.
15950154|NCT03263182|Behavioral|Introduction of the Safe Childbirth Checklist|"Adaptation of the SCC tool to Zambia: In order to produce a tool that is fully relevant to the Zambian context, a team of clinical experts from the MOH adapted the language of the SCC.
~Training of trainers on the SCC by international experts: Ariadne Labs has designed a training-of-trainers (TOT) for coach training to support quality improvement initiatives, including the implementation of the WHO SCC. Members of the district mentorship team for Nchelenge District will receive this type of TOT training.
~Following the TOT session, the district mentorship team will conduct facility-level training for health workers on using the SCC. Within target facilities, all public sector health workers will be invited to participate in the training.
~Mentorship and support to facility-level health workers on using the SCC: The district mentorship team will carry out coaching and support visits to health facilities following the initial SCC training."
15950155|NCT03263169|Behavioral|Community-based personalized care|volunteer support, health technology, interprofessional care, social network linkage
15950156|NCT03263156|Behavioral|Sleep hygiene practices and behavioural intervention|The first session will involve the provision of sleep-related psycho-education (e.g. sleep hygiene practices) and specific strategies to tackle problematic sleep-related behaviours, as well as collaborative goal setting and development of management plan tailored to the child's sleep problem for the next two weeks. The second session will involve a review of the sleep diary and a reinforcement of learned strategies, and focus on problem-solving to tackle any issues that have emerged from implementing the behavioural strategies at home. A follow-up phone call will be made two weeks later to provide parents with an opportunity to ask any further questions and to consolidate learned strategies and further troubleshoot.
15950157|NCT03263143|Other|Palliative Care|Palliative Care Consultation within 24 to 48 hours after admission
15950158|NCT03263130|Other|As above: diagnosis: COPD, Emphysema, Asthma-COPD Overlap|
15950162|NCT03263104|Dietary Supplement|Lactobacillus plantarum ECGC 13110402|Lactobacillus plantarum ECGC 13110402
15950163|NCT03263104|Dietary Supplement|Maltodextrin|
15950164|NCT03263091|Drug|FG-4592|Oral
15950165|NCT03263091|Drug|Placebo|Oral
15950166|NCT03263078|Drug|Propofol|Anesthesia was introduced by intravenous administration of 2ug/kg Fentanyl, 1mg‧kg-1 Lidocaine, 1-2mg‧kg-1 Propofol and 0.8-1.2mg‧kg-1 Rocuronium. After the endotracheal tube was inserted, anesthesia was maintained with TIVA using Target-controlled infusion(TCI) system (Orchestra® Base Primea; Fresenius Kabi, Germany) based on the pharmacokinetics model proposed by Schnider et al. with a target effect-site concentration of 3.0~5.0mcg‧ml-1. We set up routine hemodynamic monitoring including electrocardiography, oximetry, NIBP, as well as PiCCO-Technology and cerebral oximetry.
15950167|NCT03263078|Drug|Sevoflurane|Anesthesia was introduced by intravenous administration of 2ug/kg Fentanyl, 1mg‧kg-1 Lidocaine, 1-2mg‧kg-1 Propofol and 0.8-1.2mg‧kg-1 Rocuronium. After the endotracheal tube was inserted, anesthesia was maintained with inhalation anesthetic (50% O2/Air with Sevoflurane 2%). We set up routine hemodynamic monitoring including electrocardiography, oximetry, NIBP, as well as PiCCO-Technology and cerebral oximetry.
15950168|NCT03263065|Dietary Supplement|Bran|220g rice pudding meal with raspberry jam with added bran flakes
15950169|NCT03263065|Dietary Supplement|Nopal|220g rice pudding meal with raspberry jam with added nopal flakes
15950170|NCT03263065|Dietary Supplement|Psyllium|220g rice pudding meal with raspberry jam with added psyllium flakes
15950171|NCT03263052|Drug|Tacrolimus XR (Envarsus)|Elderly patients (age 60 or older) on tacrolimus experiencing neurological AEs (tremor, insomnia, vertigo, photophobia, mood disturbances, or headache) presumably from tacrolimus immediate-release or tacrolimus XL will be converted to Envarsus. This conversion will be based on the Envarsus package insert which is a 20% reduction in total daily dose and is taken once a day. The conversion from Astagraf to Envarsus will be a 36% reduction.
15950179|NCT03262948|Drug|nab-paclitaxel|albumin-bound paclitaxel is 260 mg/m2 intravenously over 30 minutes on Days 1 of each 21-day cycle cycle immediately after albumin-bound paclitaxel
15950180|NCT03262948|Drug|Paclitaxel|paclitaxel is 175 mg/m2 intravenously over 3 hours on Days 1 of each 21-day cycle cycle immediately after paclitaxel
15950181|NCT03262948|Drug|Carboplatin|carboplatin is administered on Day 1 of each 21-day，followed by paclitaxel or nab-paclitaxel
15950182|NCT03262935|Drug|(vic-)trastuzumab duocarmazine|Intravenous SYD985, Q3W
15950183|NCT03262935|Drug|Physician's choice|See drug label
15950184|NCT03262909|Device|GelrinC|Patients will undergo GelrinC implantation.
15950185|NCT03262909|Other|Microfracture historical control arm|Patients undergo an arthroscopy for evaluation purposes, followed by lesion debridement, and a standard microfracture procedure.
15950186|NCT03262857|Drug|use of magnesium sulfate with lidocaine in inferior alveolar nerve block|
15950187|NCT03262844|Behavioral|Conservative treatment|The conservative treatment group will be given diet and nursing guidance, then the drug treatment or physiotherapy will be given according to the conditions of patients. Patients with bladder dysfunction will be guided to perform routine intermittent catheterization with help of their parents.
15950188|NCT03262844|Procedure|Capsule surgery|"In the multiple segments of the spine, articular facet joint and intervertebral disc will be resected to achieve the effect of decompression.
~Specific surgical segments, osteotomy range, decompression degree of each patient needs to be designed individually."
15950189|NCT03262831|Other|Yoga|The yoga practice, Gentle Hatha and Restorative Yoga, will be based on protocols that have been found to decease fatigue and weight gain by helping the participant gain insight in recognizing stress responses and ways to relax
15950190|NCT03262831|Procedure|Blood draw|"Baseline and end of treatment
~To evaluate change in inflammatory markers (CRP, IL-6, and TNF)"
15950191|NCT03262831|Behavioral|FACT-G questionnaire|"7 statements that other people with breast cancer have said are important, the patient is to circle or mark one number per line to indicate the response as it applies in the last 7 days
~Answers range from 0=not at all to 4=very much"
15950192|NCT03262831|Procedure|Weight measurement|-Weight will be taken at baseline, on day 1 of each cycle, and the end of treatment
15950193|NCT03262831|Behavioral|Recent Physical Activity Questionnaire|-To assess physical activity, the RPAQ will be completed at baseline and at the end of treatment.
15950194|NCT03262831|Behavioral|NHANES Food Questionnaire|-To assess diet, the NHANES Food Questionnaire will be completed at baseline and at the end of treatment.
15950195|NCT03262818|Device|Transvaginal ultrasound|-Will be performed by US technologists at Washington University School of Medicine and read by Dr. Cary Siegel or Dr. Kathryn Robinson
15950196|NCT03262818|Device|Ultrasound/Photoacoustic imaging|-The light illumination for the photoacoustic imaging system is provided by a wavelength-tunable Ti:Sapphire laser (LOTIS TII), optically pumped by an Nd:YAG laser (LOTIS TII) at 532 nm wavelength.
15950197|NCT03262805|Dietary Supplement|Lanconone|. Lanconone® is a joint pain supplement containing natural herbs such as Shyonak, Ashwagandha, Shunthi, Guggul, Chopchini, Rasna and Shallaki in therapeutic quantities and documented in the ancient scriptures as pain relievers.
15950198|NCT03262805|Other|Placebo|Microcrystalline cellulose
15950199|NCT03262792|Dietary Supplement|Placebo|Microcrystalline cellulose
15950200|NCT03262792|Dietary Supplement|Andrographis Paniculata|Andrographis Paniculata 150 mg
15950201|NCT03262792|Dietary Supplement|Andrographis Paniculata|Andrographis Paniculata 300 mg
15950202|NCT03262779|Biological|combination nivolumab and ipilimumab|Combination therapy with nivolumab 3 mg/kg administered intravenously (IV) every 2 weeks, with ipilimumab 1 mg/kg administered IV every 6 weeks.
15950203|NCT03262766|Other|Acute Intermittent Hypoxia (AIH)|This will consist of up to 90 seconds of 9-10% O2 (FiO2 0.09), alternating with up to 90 seconds of 21% O2 (normoxic air FiO2 0.21). The delivery of hypoxia and normoxic air mixtures will be repeated up to 18 times per session each, for a total of up to 45 minutes.
15950204|NCT03262766|Behavioral|Upper extremity training|Subjects will receive 45 minutes of task-specific, high repetition upper extremity training, given using an upper-limb robotic rehabilitation device, the Armeo Spring®. Armeo Spring is a gravity support system based on an ergonomic arm exoskeleton with integrated springs. It cradles the entire arm, from shoulder to the hand, and counterbalances the weight of the user's arm. Therefore, it enhances any residual function and neuromuscular control, and assists in active movement across a large 3-D workspace. The Armeo software contains an extensive library of game-like movement exercises supported by a virtual-reality training environment that displays the functional task along with immediate performance feedback.
15950205|NCT03262766|Other|Sham Acute intermittent hypoxia|This will consist of up to 90 seconds of 21% O2 (FiO2 0.21), alternating with up to 90 seconds of 21% O2 (normoxic air FiO2 0.21). The delivery of alternating normoxic air will be repeated up to 18 times per session each, for a total of up to 45 minutes.
15950206|NCT03262753|Procedure|Surgery|Primary end-to-end surgical treatment of coarctation of the aorta
15950207|NCT03262753|Procedure|Balloon dilation|Primary balloon dilation treatment of coarctation of the aorta
15950208|NCT03262753|Procedure|Stent|Primary stent dilation treatment of coarctation of the aorta
15950209|NCT03262740|Drug|BMS-986195|Oral administration of specified dose on specified days
15950210|NCT03262740|Drug|Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 μg ethinyl estradiol)|Oral Contraceptive
15950211|NCT03262727|Drug|BMS-986165|Oral administration of specified dose on specified days
15950212|NCT03262727|Drug|Loestrin 1.5/30 (1.5 mg norethindrone acetate/30 μg ethinyl estradiol)|Oral Contraceptive
15950213|NCT03262714|Other|Dance|Participants randomized to the dance group will take part in a dance intervention programme for 8 weeks, including 3 sessions per week, each lasting 60 min. Dance classes will be performed in group in a dance studio, including a variety of rhythms such as salsa, jazz and aerobics. The dance session wil include a warm up of 15 min (posture, join mobility and dance technique), a main part of 40 min (learning of specific choreographies and practice of moves across the floor), and a cool down of 5 min (muscle stretching and relaxation).
15950290|NCT03262103|Procedure|Radical Prostatectomy|as per standard care
15950291|NCT03262090|Drug|0.2ug/kg dexmedetomidine|subjects were randomly assigned to receive 0.2ug/kg intravenous dexmedetomidine before skin incision
15983895|NCT03008369|Other|Laboratory Biomarker Analysis|Correlative studies
15950214|NCT03262714|Other|Walking|Participants randomized to the walking group will take part in a walking intervention programme for 8 weeks, including 3 sessions per week, each lasting 60 min. The walking session will include a warm up of 10 min (posture and join mobility), a main part of 40 min (walking on a treadmill with a heart rate corresponding to 60% of VO2peak), and a cool down of 10 min (muscle stretching and relaxation).
15950215|NCT03262714|Other|Stretching|Participants randomized to the control group will take part in stretching classes, once a week, each lasting 60 min, also for 8 weeks. Stretching exercises for large muscle groups will be performed standing or in a match, holding the positions for a maximum of 10 s. There will be no music playing during the session.
15950216|NCT03262701|Drug|Hydrogen Peroxide Gel, 13 weeks|13 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.
15950217|NCT03262701|Drug|Hydrogen Peroxide Gel, 26 weeks|26 weeks of twice-daily use of custom tray application of 1.7% peroxide gel as an adjunct to scaling and root planing in the treatment of chronic periodontitis.
15950218|NCT03262701|Other|Scaling and Root planing group|Subjects will receive the standard of care which is conventional non-surgical therapy for chronic periodontitis without custom tray application of 1.7% peroxide gel
15950219|NCT03262688|Drug|Bupivacaine HCl collagen-matrix implant|Placement of the bupivacaine collagen-matrix in the surgical site
15950220|NCT03262688|Drug|Bupivacaine HCl infiltration|Infiltration of the surgical site
15950221|NCT03262662|Drug|Varenicline|oral varenicline tablets
15950222|NCT03262662|Behavioral|Brief smoking cessation counseling|~10-minute individual counseling at each of 6 clinic visits
15950223|NCT03262636|Drug|Indocyanine Green|Indocyanine Green
15950224|NCT03262623|Other|Radial nerve block|A nerve stimulator will be used to localize the radial nerve. Then radial block will be performed. At this point 3-5 ml of the anesthetic mixture is injected. Each 10 ml of the anesthetic mixture contained: 3ml lidocaine 2%, 3ml lidocaine 2% with epinephrine, 1:2000,000, 3ml bupivicaine 0.5% and 1ml clonidine 150 µg/ml.
15950225|NCT03262623|Other|Placebo|A nerve stimulator will be used to localize the radial nerve. Then radial block will be performed containing normal saline
15950226|NCT03262610|Drug|Setmelanotide|daily subcutaneous injection
15950227|NCT03262597|Other|enterade|Subjects will consume enterade, which is an amino acid-based oral rehydration solution.
15950228|NCT03262597|Other|Pedialyte|Subjects will consume Pedialyte
15950229|NCT03262597|Other|Gatorade|Subjects will consume Gatorade
15950230|NCT03262597|Other|Water|Subjects will consume water as the control beverage
15950231|NCT03262571|Diagnostic Test|Lung ultrasound|Duretic therapy is then optimized according to the presence and severity of B-lines in group A.
15950232|NCT03262558|Other|No intervention|Patients will undergo standard clinical routine practice in this indication
15950233|NCT03262545|Drug|apatinib|Patients in experimental group will take 500mg apatinib daily orally，and patients in control group will take placebo
15950234|NCT03262545|Drug|Placebos|Physical properties of placebos are consistent with apatinib
15950235|NCT03262532|Other|Web-base simulator|Training manipulation of TEE using a Web-based simulator
15950236|NCT03262532|Other|No web-base simulator|Training manipulation of TEE with out a web-base simulator
15950237|NCT03262519|Diagnostic Test|Computer based neurocognitive testing|Iowa Gambling Task, The Balloon Task, Intertemporal choices task, Cognitive Reflection Test, Physiological and self-reported measures of OSA/sleep related symptoms, General health and physiological measures.
15950238|NCT03262506|Other|Computerized cognitive training|The cognitive training program consists of a set of computerized exercises designed to improve the speed and accuracy of auditory information processing while engaging neuromodulatory systems involved in attention and reward. These exercises continuously adjust the difficulty level to user performance to maintain an approximately 85% rate of correct responses. Trials with correct responses are rewarded with points and animations.
15950239|NCT03262493|Device|Interventional Group|Use of the feeding tube attachment device (FTAD).
15950240|NCT03262480|Other|stroke volume optimization|"Hemodynamic variables including stroke volume (SV), stroke volume variation (SVV), stroke volume index (SVI), cardiac output (COP), cardiac index (CI), systemic vascular resistance (SVR), systemic vascular resistance index (SVRI), thoracic fluid content (TFC), corrected flow time (FTC), index of contractility (ICON), systolic time ratio (STR), oxygen delivery (DO2) and oxygen delivery index (DO2I) will be measured by Cardiac output non-invasive monitor (ICONTM, OSYPKA medical cardiotronic GMBH, Elixir, Germany). Heart rate (HR), mean arterial blood pressure (MAP), central venous pressure (CVP) and arterial oxygen saturation (Sao2) will be measured using HP monitor.
~If mean arterial blood pressure(MAP) drops below 65 mmHg despite achievement of SVopt and CVPmax in both groups, a bolus dose of 5 mg ephedrine will be given and repeated as needed .Norepinephrine will be given for persistent hypotension.Dobutamine 5 mic/kg/min will be started if cardiac index less than 2.5 l/m2."
15950241|NCT03262467|Procedure|Aneurysmorrhaphy with or without external porous prosthesis (Provena©, BBraun)|In patients with aneurysm of native vascular access indicated for surgical treatment, aneurysmorrhaphy with or without external porous prosthesis (Provena©, BBraun) wil be performed.
15950242|NCT03262454|Drug|Atezolizumab|Patients undergo hypofractionated radiation therapy with 24 Gy over 4 fractions in days 1-4 of 1st cycle of atezolimumab and receive Atezolizumab 1200 mg fixed dose via intravenous on day 1 of each 3-week cycle until disease progression or unacceptable toxicity occurs.
15950243|NCT03262441|Drug|Mycophenolate Mofetil 500Mg Tab|500 mg once daily for one week. If tolerating the drug, then initiate twice daily for 22 months
15950244|NCT03262428|Other|Semi-structured interviews|Patients, caregivers and health care professionals involved in self-management support will be sought via patient organizations and professional organizations in the region. Study information materials will be provided to these organizations for dissemination to their members, providing also contact details of the study team for interested individuals to register their interest and provide basic eligibility and screening information. Selected participants will be invited to take part in a face-to-face or telephone interview about (supporting) self-management. Data collection will consist of semi-structured interviews conducted either face-to-face or by telephone.
15950292|NCT03262090|Drug|0.4ug/kg dexmedetomidine|subjects were randomly assigned to receive 0.4ug/kg intravenous dexmedetomidine before skin incision
15983896|NCT03008369|Drug|Lenvatinib|Given PO
15950245|NCT03262415|Device|LabPatch Continuous Glucose Monitoring (CGM)|"The patch device that will be applied to subjects' arms in this study is about 3 inches in length and one inch in width, with adhesive tape on the sides.
~The LabPatch circuit chip lies on the underside of the bandage. The circuit is in the form of a small chip (approximately 15.7 mm [0.618] x 15.7 mm [0.618]) placed in contact with the skin. The chip has a telescopic micropipette which draws interstitial fluid to be analyzed for glucose levels. The chip is also able to measure skin temperature to ensure appropriate skin contact.
~A wire that connects the chip to a laptop that continuously captures glucose data."
15950246|NCT03262402|Procedure|Basic periodontal treatment|Basic periodontal treatment consists of scaling and root planing performed with manual curettes or ultrasonic instruments.
15950247|NCT03262389|Drug|Fludeoxyglucose PET CT|Route of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi).
15950248|NCT03262389|Drug|Sodium Acetate C11 PET CT|Route of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq).
15950249|NCT03262389|Drug|Fludeoxyglucose PET MRI|Route of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi).
15950250|NCT03262389|Drug|Sodium Acetate C11 PET MRI|Route of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq).
15950251|NCT03262376|Dietary Supplement|Minerals + Vitamins|A mineral and vitamin tablet
15950252|NCT03262376|Dietary Supplement|Botanical A|Botanical extract administered in capsule form
15950253|NCT03262376|Dietary Supplement|Botanical B|Botanical extract administered in capsule form
15950254|NCT03262376|Other|Placebo|Cellulose crystalline tablet
15950255|NCT03262363|Combination Product|Curcumin/NFE2L2 A>G|The administration will be orally and the patient will be instructed to take two capsules per day for one week, one in the morning 15 minutes before breakfast and another at night 15 minutes before dinner, accompanied by a cup of 240 mL of pure water. It will be indicated to continue with their usual medical treatment.
15950256|NCT03262363|Combination Product|Placebo/NFE2L2 A>G|The administration will be orally and the patient will be instructed to take two capsules for 24 weeks, one in the morning 15 minutes before breakfast and another in the evening 15 minutes before dinner, accompanied by a 240 mL cup of pure water. They will be advised to continue their usual medical treatment.
15950257|NCT03262350|Behavioral|Yoga|The yoga classes will be adapted to all levels of experience, mobility, and body size. Specific breathing techniques and body positive language will be incorporated into a body-positive yoga training done by Ms. Lisa Diers, RDN, E-RYT, YACEP. Less focus will be placed on precision of the poses, instead focus will be on body feelings, except where physically dangerous. Thus, the overall focus will be on listening to one's own body. List of messages will be carefully designed to be related to eating and weight, but to not be directly discussed. Ms. Diers will travel to Delaware to lead the intervention training for yoga instructors prior to the study taking place.
15950258|NCT03262337|Other|none, this is an observational study|none, this is an observational study
15950259|NCT03262324|Other|VAS-FA Turkish version|Self-reported outcome questionnaires
15950260|NCT03262311|Other|Hypoxia marker|Single oral dose of pimonidazole 500 mg/m2
15950261|NCT03262298|Biological|Anti-CD22-CAR-transduced T cells|a single dose of Anti-CD22-CAR-transduced T cells will be infusion after preconditioning.
15950262|NCT03262285|Procedure|phacoemulsification|removal of cataract using ultrasound waves
15950263|NCT03262285|Procedure|extracapsular cataract extraction|removal of cataract using surgical corneal incision
15950264|NCT03262272|Device|VIE A Hemodialyzer|polysulfon membrane coated with vitamin E
15950265|NCT03262272|Device|Rexsys 27H hemodialyzer|polyethersulfon membrane with large surface area : 2,7m²
15950266|NCT03262272|Device|Leoceed 21HX hemodialyzer|polyslfon membrane with gamma sterilization
15950267|NCT03262272|Device|Polypure 22S+ hemodialyzer|polysulfon membrane with steam sterilization
15950268|NCT03262259|Behavioral|GSDG multi-component intervention|Multi-component intervention, including screening and brief intervention, other evidence-based interventions, and novel or partially tested interventions that warrant further evaluation.
15950269|NCT03262246|Other|medical report consultation|investigators consult medical report concerning patient identified for cerebral amyloid angiopathy
15950270|NCT03262233|Combination Product|nicotine|
15950271|NCT03262233|Other|placebo|
15950272|NCT03262220|Radiation|Volumetric Arc Therapy (VMAT)|Total Marrow Irradiation: 12 Gy in 3 fractions of 4 Gy on 3 consecutive days with a concomitant simultaneous integrated boost (SIB) of 4.5 Gy x 3 fractions delivered to active bone marrow (ABM).
15950273|NCT03262207|Other|Extraction genomic DNA|
15950274|NCT03262207|Other|Analysis of methylation profiles of numerous GSI and TE|
15950275|NCT03262207|Other|Analysis of methylation for the whole genome (sub-population of 15 samples from group 1)|
15950276|NCT03262207|Other|Method of protein detection by immunostaining and flow cytometry|
15950277|NCT03262181|Other|Isometric Exercise|5 sets of 45-seconds quadriceps contraction, each followed by 2-minutes of rest.
15950278|NCT03262181|Other|Sham Transcutaneous Electrical Nerve Stimulation|5 sets of 45-seconds intervals without quadriceps contraction, each followed by 2-minutes of rest.
15950279|NCT03262168|Other|Exercise Programme|Complete background demographics, Sniff Nasal Inspiratory Pressure (study group one only), grip strength, muscle strength, PHQ-9 and GAD-7 questionnaires.
15950280|NCT03262155|Biological|Blood test|
15950281|NCT03262142|Drug|Piperacillin/tazobactam|Intravenous Piperacillin/tazobactam three times daily
15950282|NCT03262142|Drug|Ciprofloxacin|Oral Ciprofloxacin twice daily
15950283|NCT03262116|Drug|Humalog|Subjects will participate in one week of wearing the insulin only bionic pancreas using humalog as the rapid acting insulin.
15950284|NCT03262116|Drug|Novolog|Subjects will participate in one week of wearing the insulin only bionic pancreas using novolog as the rapid acting insulin.
15950285|NCT03262116|Drug|BC222 insulin lispro|Subjects will participate in one week of wearing the insulin only bionic pancreas using BC222 insulin lispro as the rapid acting insulin.
15950286|NCT03262116|Device|Bionic Pancreas|The insulin-only bionic pancreas will be used in all three arms of the study
15950287|NCT03262103|Biological|Intratumoral (IT) Poly ICLC 0.5 mg|0.5 mg IT once/week (week 1)
15950288|NCT03262103|Biological|Intratumoral (IT) Poly ICLC 1.0 mg|1.0 mg IT once/week (week 1)
15950293|NCT03262090|Drug|0.6ug/kg dexmedetomidine|subjects were randomly assigned to receive 0.6ug/kg intravenous dexmedetomidine before skin incision
15950294|NCT03262090|Drug|0.8ug/kg dexmedetomidine|subjects were randomly assigned to receive 0.8ug/kg intravenous dexmedetomidine before skin incision
15950295|NCT03262090|Drug|1.0ug/kg dexmedetomidine|subjects were randomly assigned to receive 1.0ug/kg intravenous dexmedetomidine before skin incision
15950296|NCT03262077|Drug|Methylene Blue|Irradiation with low-level laser for 1, 3, and 5 min
15950297|NCT03262077|Drug|Methylene Blue Oral Product|Irradiation with low-level laser for 1, 3, and 5 min
15950298|NCT03262064|Combination Product|Pulmonary function tests,Bronchiectasis severity index score|"Pulmonary function tests: including spirometry, DLCO, and lung volumes. Sputum investigations: The following investigations will be performed on fresh sputum samples; gram stains and culture, smear and culture for mycobacteria and fungi and antibiotic sensitivity tests Bronchoscopy: Bronchoscopy with bronchoalveolar lavage will be used to obtain specimens for staining and culture to identify type of colonization.
~Radiology: All patients will have a chest radiograph (PA and lateral) and high-resolution computed tomography (HRCT) scan.
~Bronchiectasis severity index score parameters FACED Score"
15950299|NCT03262051|Diagnostic Test|CYP phenotyping|Phenotyping using a simplified version of the Geneva cocktail
15950300|NCT03262038|Drug|Ondansetron|This arm will receive (in a blinded fashion) 0.1 mg/kg of Ondansetron IV made up to 5 mLs intra-operatively and Ondansetron IV 0.1 mg/kg made up to 5 mLs every 6 hours for 24 hours postoperatively.
15950301|NCT03262038|Drug|Placebo Comparator|This arm will receive (in a blinded fashion) a volume-matched placebo intraoperatively as well as IV every 6 hrs for 24 hours postoperatively.
15950302|NCT03262025|Procedure|Operated|Patients were either managed conservatively or underwent emergency laparotomy
15950303|NCT03262012|Drug|BGF MDI (PT010)|Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol, BGF MDI, PT010
15950304|NCT03262012|Drug|GFF MDI (PT003)|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol, GFF MDI, PT003
15950305|NCT03262012|Drug|BFF MDI (PT009)|Budesonide and Formoterol Fumarate Inhalation Aerosol, BFF MDI, PT009
15950306|NCT03262012|Drug|Symbicort® Turbohaler® Inhalation Powder|Budesonide and Formoterol Fumarate Inhalation Powder, Symbicort® Turbohaler® Inhalation Powder, Symbicort Turbohaler
15950307|NCT03261999|Drug|Leuprolide Mesylate|Subcutaneous injection of 25mg Leuprolide Mesylate
15950308|NCT03261986|Radiation|Radiostereometric Analysis|RSA exams of the operative hip are received post-op day 1, and at 6 weeks, 3 months, 6 months, 1 year and 2 years following surgery
15950309|NCT03261986|Procedure|total hip arthroplasty with RSA bead implantation|Patients receive RSA beads inserted into the bone surrounding the Trident II implant.
15950310|NCT03261973|Device|DV8|DV8 esophageal deviation tool
15950311|NCT03261960|Drug|BLI4700|Oral bowel preparation
15950312|NCT03261960|Drug|Magnesium bowel preparation|Oral bowel preparation
15950313|NCT03261947|Drug|TAK-931|TAK-931 hard gelatin capsules
15950314|NCT03261934|Other|No intervention|No intervention
15950315|NCT03261921|Drug|Dexamethasone|Dexamethasone is used peri -operatively mainly to prevent nausea and vomiting. Also epidural administration of dexamethasone prolong the postoperative analgesia and reduce analgesic needs
15950316|NCT03261921|Drug|Dexmedetomidine|Dexmedetomidine is an alpha 2 agonist which has sedative ,analgesic, opioid sparing effect and was proved to prolong the duration of postoperative analgesia when added to local anesthetics
15950317|NCT03261921|Drug|Bupivacaine|local anesthetic agent
15950318|NCT03261908|Genetic|detection of genotype|detection of genotype by next generation sequencing
15950319|NCT03261895|Behavioral|Nurse-led Integrative health and wellness programme|Participants in the intervention group will go through a eight-session structured education programme. The education programme was designed by incorporating the evidences of diabetes care from the western medicine and the philosophy of traditional Chinese medicine.
15950320|NCT03261882|Other|Nativity|Mexican-American children were subdivided into two groups based on their country of birth. Mexican-American children who were not born in the U.S. were considered foreign-born and those born in the U.S. were U.S.-born.
15950321|NCT03261869|Other|Cold application|
15950322|NCT03261843|Biological|autologous platelet rich plasma|adding autologous platelet rich plasma to the bone graft harvested from the patient
15950323|NCT03261843|Procedure|posterior lumbar interbody fusion without autologous platelet rich plasma|performing posterior lumbar interbody fusion without using platelet rich plasma
15950324|NCT03261830|Drug|Cefazolin|Primary intervention
15950325|NCT03261830|Drug|Clindamycin|For use in Pre-operateive Antibiotics arm in cases of documented allergy to primary intervention.
15950326|NCT03261830|Drug|Saline|Placebo Intervention
15950327|NCT03261817|Behavioral|Physical activity (APA)|"2 sessions a week of 1 hour during 16 weeks. APA exercises by web will be aerobic type associated with muscle toning program; Activities will combine relaxation techniques, body expression and muscle relaxation (yoga, stretching, relaxation, step etc ...).
~The intensity of the activities will be individualized for each participant according to his/her physical condition"
15950328|NCT03261817|Behavioral|Health Education program (HE)|2 sessions a week of 1 hour during 16 weeks HE by web will be delivered and was composed of information on the main mental disorders, the benefits of physical activity, healthy lifestyle (dietary balance, sleep cycle, stress management), alcohol, drug, tobacco and cardiovascular risk factors
15950329|NCT03261804|Behavioral|relation between vaginal douching and vaginal infection|personal hygiene including performing external or Internal vaginal douching, how she is performing this douching (by hand, water, jet, pump), how frequent and why they perform this internal vaginal douche.
15950330|NCT03261791|Drug|Apatinib|Apatinib mesylate tablets 500 mg po qd.
15950331|NCT03261778|Device|Acromion 2.0 Brace|Acromion 2.0 Brace will be worn for 6 weeks instead of the conventional Mitella sling
15950332|NCT03261765|Other|Assessment of adhesions|Modified Nair scoring system
15950333|NCT03261752|Diagnostic Test|blood sample|Total genomic DNA will be extracted DNA extraction kit using a QIAamp DNA Blood Mini kit .Genetic analysis of both SPG20 &STK31 by RTPCR.
15950334|NCT03261739|Biological|RYI-018|Anti-CB1 monoclonal antibody
15950335|NCT03261739|Biological|Placebo|Placebo
15983897|NCT03008369|Other|Quality-of-Life Assessment|Ancillary studies
15950336|NCT03261726|Device|MedEl Test Electrode Placer|This study uses a sterile dummy (i.e., not working) cochlear implant electrode inserted at the time of tumor removal to keep the inner ear from scarring or filling with bone. The significance of this to you is that if you ever become eligible for a cochlear implant sometime after surgery, it may be possible to remove the dummy and insert a functioning cochlear implant.
15950337|NCT03261713|Device|Virtual reality|Virtual reality training is provided using Jintronix Rehabilitation software. A Kinect camera captures the movements of the participant using infrared technology and allows them to control an avatar, which interacts with an activity. Several games and activities are available to train standing balance (ex. slalom skiing), reaching (ex. planting seeds/harvesting tomatoes), stepping (ex. whack-a-mole), gentle strengthening (ex. knee extensions) and aerobic exercises (ex. marching on the spot). Game and activity difficulty can be increased by requiring more repetitions, or greater speed, distance and/or accuracy. Specific games and activities, and their parameters are customized for each participant. The exercise plan is performed 5 times a week for 6 weeks for 30 minutes at each session.
15950338|NCT03261713|Device|Control|Participants in the control group are provided with an iPad which contains a selection of apps suited for memory (ex. memory card game), cognition (Sudoku, cross-word), visual tracking (word search) and fine motor skills (ex. writing, whack-a-mole). Participants are instructed to perform their exercise plan 5 times a week for 6 weeks for 30 minutes at each session.
15950339|NCT03261700|Behavioral|RISE|This provider- administered brief- counseling intervention program will increase Women Veteran's self- efficacy in addressing violence in their current or past relationships. The variable length (up to six- session) modular-based intervention aims at providing resources for WVs in the relevant domains of: 1) safety planning, 2) education on health effects of IPV and red flags, 3) improving coping and self- care, 4) enhancing social support, 5) making difficult decisions, and 5) connecting with resources.
15950340|NCT03261700|Other|Information and referral condition|Participants randomized to this arm will receive a brochure-based intervention, consisting of education, support and problem solving, safety planning as well as resources and referrals to address an array of health and social issues associated with IPV (including in VA and the community).
15950341|NCT03261687|Other|water based exercise|
15950342|NCT03261687|Other|land based exercise|
15950343|NCT03261687|Behavioral|advice|general advice given to all subjects
15950344|NCT03261674|Behavioral|CBT-I|Cognitive Behavioral Therapy for Insomnia (CBT-I)
15950345|NCT03261674|Behavioral|ABT-I|Arousal-Based Therapy for Insomnia (ABT-I)
15950346|NCT03261661|Behavioral|Reading|Students are taught the processes involved in hearing, seeing, and feeling sounds as well as differences between sounds in words. New knowledge is built on previous knowledge in a step-by-step manner. Sounds build to letter-sound relationships to reading of words and syllables. Students learn the connection between reading of words (decoding) and writing/spelling words (encoding) building from simple words to multisyllabic words to text reading with fluency and understanding.
15950347|NCT03261661|Behavioral|Mindset|Blended learning program with online and teacher-directed activities related to how the brain functions, learns, and remembers, and how it changes in a physical way when we exercise it. Instruction in how students are in control of their brain and its development, and how to apply this to their schoolwork with practical strategies for tackling academic challenges.
15950348|NCT03261661|Behavioral|Reading Embedded with Mindset|Mindset training explicitly linked to the reading content through lesson openers, feedback prompts, and self-monitoring of mindset during reading work.
15950349|NCT03261661|Behavioral|Business as Usual|Reading interventions already provided to students with reading difficulties as per typical procedures at the participating school
15950350|NCT03261648|Other|State-Trait-Anxiety Inventory (Forme Y) questionnaire|after admission in the emergency department, patient and his partner will completed STAI Y questionnaire.
15950351|NCT03261648|Other|pain level scale|as usual caregiver will ask to the patient to evaluated his pain level with a scale of one to ten
15950352|NCT03261635|Drug|Ranibizumab Injection|patients received monthly 0.5 mg ranibizumab intravitreal injections for 3 months, after which monthly injections were administered pro re nata
15950353|NCT03261635|Drug|Indomethacin|patients self-administered one drop of indomethacin 0.5% eye drops three times a day for 12 months
15950354|NCT03261622|Device|Sacral nerve stimulation at different stimulation amplitudes|Exploring the effect of different stimulation amplitude in a randomized study
15950355|NCT03261609|Other|preterm birth|The study compares young adult subjects born premature (< 29 weeks) versus term (-> 37 weeks)
15950356|NCT03261596|Drug|Mebendazole|Participants will be randomized using a 1:1 ratio to one of the two arms. Study participants eligible for treatment will be randomly assigned to one of the two treatment arms using a computer-generated stratified block randomization code.
15950357|NCT03261583|Other|Thoracis Surgery - Common care|Observational study. It is only a matter of collecting clinical data.
15950358|NCT03261570|Drug|Pyridostigmine|60mg by mouth
15950359|NCT03261570|Drug|Digoxin|0.5 (500mcg) by mouth
15950360|NCT03261570|Drug|Placebo|Lactulose 50mg by mouth
15950361|NCT03261557|Behavioral|CBT + SST|"It will consist of 1 individual sessions and 15 weekly periodicity group sessions distributed in 3 modules: cognitive skills module, which includes the basic principles of CBT for psychosis; Social skills module, which includes the usual strategies in HHSS training; and problem solving module.
~All patients will receive pharmacological treatment and will be followed up by their referral psychiatrist habitual."
15950362|NCT03261557|Behavioral|Psychoeducation, habits and healthy lifestyle|"Patients randomized to the control treatment will receive the same number of Individual and group sessions, with the same periodicity and format: 1 individual sessions and 15 weekly periodicity group sessions distributed in 3 modules: psychoeducation, habits and healthy lifestyle.
~All patients will receive pharmacological treatment and will be followed up by their referral psychiatrist habitual."
15950363|NCT03261544|Procedure|Proximal Femur Replacement|The purpose of this study is to assess the functional outcomes in patients undergoing proximal femur resection and reconstruction with an endoprosthesis, based on the abductor muscle repair technique.
15950364|NCT03261531|Device|Transcutaneous electrical nerve stimulation (TENS)|Participants will be treated before and after two meals of the day with T6 dermatomal electrical stimulation delivered by a TENS unit.
15950551|NCT03259906|Other|DASH score|Questionnaire asking about Disability of Arm, Shoulder and Hand
15950365|NCT03261518|Procedure|inferior vena cava ultrasound|Place the patient in the supine position. The degree of elevation of the head of the bed has not been shown to make a significant difference in measurements. The diameter of the IVC for calculation of the caval index should be measured 2 cm from where it enters the right atrium .An alternative way to visualize respiratory variation is to use M-mode, with the beam overlying the IVC 2 cm from the right atrium.The inspiratory and expiratory diameter can then be measured on the M-mode image, at the smallest and largest locations, respectively.
15950366|NCT03261505|Device|Acupuncture|Patients will watch a video of themselves receiving acupuncture or a control video or receive real or sham acupuncture treatment.
15950367|NCT03261492|Behavioral|Physical Activity|SAGE curriculum is a garden-based PA and nutrition educational program for early care and education centers.
15950368|NCT03261492|Behavioral|Child Safety Attention Comparison|The goal of this comparison group is to provide centers with an engaging, useful, carefully sequenced, and easy-to-deliver curriculum so that randomization to this group does not influence attrition or reach and serves as a placebo (unlikely to affect outcomes of interest).
15950369|NCT03261479|Diagnostic Test|Thermal image|We will take a non-invasive thermal image with the FLIR ONE thermal imaging camera that attaches to a study-designated iPhone.
15950370|NCT03261466|Drug|Bifidobacterium breve BR03 and Bifidobacterium breve B632|
15950371|NCT03261466|Drug|Placebos|
15950372|NCT03261453|Device|Active Elipse Device|Intervention Device
15950373|NCT03261453|Device|Elipse Sham Device|Control Device
15950374|NCT03261427|Drug|Lyrica 150Mg Capsule|150 mg oral administered (BID)
15950375|NCT03261427|Drug|YNP-1807 330Mg Tablet|330 mg oral administered (QD)
15950376|NCT03261414|Procedure|Hypnosis|A short preanesthetic hypnosis before induction of anesthesia
15950377|NCT03261414|Procedure|usual care|Standard care before induction of anesthesia
15950378|NCT03261401|Drug|M5717|Subjects will receive single ascending oral dose of M5717 after at least 8 hours of fasting together with water on Day 1, followed by a 4-hour post-dose fast
15950379|NCT03261401|Drug|M5717|Subjects will receive multiple ascending oral doses of M5717 after an overnight fast of at least 8 hours once daily for 3 days, followed by a 4-hour post-dose fast
15950380|NCT03261401|Drug|Placebo|Subjects will receive placebo matched to M5717
15950381|NCT03261401|Drug|M5717|Subjects will receive single ascending oral dose of M5717 from Part A or as applicable multiple ascending oral doses of M5717 from Part B after at least 8 hours of fasting together with water on Day 1, followed by a 4-hour post-dose fast
15950382|NCT03261388|Behavioral|Activity-Based Locomotor Exercise Program (ABLE)|The ABLE program is an intensive locomotor based intervention that is offered at the Golden Valley Courage Kenny Rehabilitation Institute.
15950383|NCT03261375|Device|Renal Denervation System|A renal denervation system with a 6 electrodes-on-net structure catheter
15950384|NCT03261375|Drug|Antihypertensive Agents|Calcium channel blocker，Diuretic
15950385|NCT03261375|Device|Sham Procedure|Catheterization without renal denervation
15950386|NCT03261362|Dietary Supplement|Branched-chain amino acids reduced intake|
15950387|NCT03261349|Drug|Ledipasvir and sofosbuvir|To assess whether Harvoni® (ledipasvir and sofosbuvir) could eradicate HCV and lead to durable complete remission of these lymphomas.
15950388|NCT03261336|Drug|Calcitriol, Ketoconazole, Hydrocortisone|Calcitriol (0.5 mcg caplets) given in escalating doses, orally QD X3 consecutive days every week Ketoconazole, 200 mg tablets, 2 tablets orally TID Hydrocortisone 20mg AM, 10mg PM orally starting in the evening before the first dose of Calcitriol
15950389|NCT03261323|Procedure|Immediate Breast Reconstruction|Only implant based surgeries will be considered in this study. The patient will be followed for at least 1 year after the last reconstruction surgery. Reconstruction will be attempted immediately after mastectomy.
15950390|NCT03261323|Procedure|Delayed Breast Reconstruction|Risk reduction strategies on smoking, weight, and chronic disease control will be offered. The individual risk will be recalculated every three months. Delayed breast reconstruction will be offered when core cancer therapies (mastectomy, chemotherapy and radiation) are complete. Only implant based surgeries will be considered in this study. The patient will be followed for at least 1 year after the last reconstruction surgery.
15950391|NCT03261323|Other|Breast-Q questionnaire|Developed out of Memorial Sloan-Kettering Institute for Cancer Research, this questionnaire is designed to create a patient-reported outcome measure to provide quantifiable information about the impact and effectiveness of breast surgery. In this study it will be used for quality of life assessment
15950392|NCT03261310|Drug|Acetaminophen or Placebo|"Study subject will receive either 1000mg of acetaminophen in 100ml own diluent, or 100ml of saline during their intra-operative period and an order will be placed in their chart/Essentris order for No acetaminophen for 6 hours post operatively."
15950393|NCT03261284|Drug|Dabigatran Etexilate 150 MG [Pradaxa]|Dabigatran Etexilate 150mg,bid
15950394|NCT03261284|Drug|Warfarin Pill|Add warfarin dose according to INR values.
15950395|NCT03261271|Behavioral|Weight Loss Program|Program involves one-on-one coaching, diet meal plan, and physical activity plan.
15950396|NCT03261271|Behavioral|Standardized educational flyer|"The American Institute for Cancer Research handout Nutrition and the Cancer Survivor will be provided to participants."
15950397|NCT03261271|Behavioral|Weight Maintenance Program|Post-surgery program involves group support sessions, phone check-ins, and diet and exercise monitoring.
15950398|NCT03261258|Other|Questionnaire|
15950399|NCT03261219|Device|Intrapulmonary Percussive ventilation|mode of airway clearance using mouthpiece and alternating air currents applied directly to the airway
15950400|NCT03261219|Device|Chest Physiotherapy Vest (Incourage)|mode of airway clearance using external vibratory vest
15950401|NCT03261206|Other|5-ASA Withdrawal|Withdrawal of 5-ASA therapy
15950402|NCT03261193|Drug|ITM + Sham QLB|Sham subcutaneous non-anesthetic infiltration with saline
15950403|NCT03261193|Drug|ITM + Bupivacaine QLB|QL plane block with local anesthesia
15950404|NCT03261180|Other|Best Practice|Receive regular diet
15950405|NCT03261180|Other|Laboratory Biomarker Analysis|Correlative studies
15950406|NCT03261180|Dietary Supplement|Nutritional Intervention|Receive Nestle Impact AR
15950552|NCT03259906|Procedure|X-ray|postoperative x-rays at 6 weeks, 3, 6 and 12 months
15950407|NCT03261167|Drug|Botulinum toxin A (GSK1358820)|GSK1358820 is sterile, purified type A botulinum neurotoxin complex. GSK1358820 injection will contain botulinum toxin A (100 units), sodium chloride (0.9 milligrams [mg]), and human serum albumin (0.5 mg). It will be available with doses of 400 units and 240 units.
15950408|NCT03261167|Drug|Placebo|Placebo injection will contain sodium chloride (0.9 mg).
15950409|NCT03261141|Combination Product|(PV-RQOL),(APA) ,Acoustic analysis|"severity and character of dysphonia (measured by Auditory Perceptual Assessment using a modified GRBAS scale which gives scores as regard the degree and severity of dysphonia and its character.
~Acoustic Analysis of voice : which is Computerized Speech Laboratory analysis of voice that gives the following measures jitter (%), shimmer (dB), and harmonic to noise ratio (H/N).
~the degree of social ,emotional ,functional and physical disturbance ,if present in those children with voice disorders by application of The Arabic Pediatric Voice Related Quality of Life (PV-RQOL)."
15950410|NCT03261128|Other|Self-questionnaire|Filling of a self-questionnaire before each chemotherapy cure
15950411|NCT03261115|Procedure|No topical anesthesia|Lack of use of topical anesthesia application prior to infiltration injection intra-orally
15950412|NCT03261102|Biological|Adalimumab|
15950413|NCT03261076|Behavioral|Strategies Enhancing Reading in Older Underperf. Students|Strategies for Enhancing Reading in Older Underperf. Students (SERIOUS) combines two scientific, research based intervention programs, each meeting specific need of youth in detention: (1) Stevenson Reading Program, manualized and uniquely suited to students with phonological awareness, attention, and memory difficulties that may impact reading; and (2) Dr. Sharon Vaughn's well-documented, validated program, explicitly designed for older, severely reading-impaired students. SERIOUS also includes: (3) metacognitive strategies for self-regulated learning, and (4) A gamified extension of the intervention on a SmartPhone, designed to reinforce word-level skills (e.g., decoding, automaticity, and vocabulary), and including features efficacious for learning.
15950414|NCT03261063|Device|Evera MRI ICD System|Subjects are implanted with Evera MRI ICD System and exposed to MRI environment per study requirements
15950415|NCT03261050|Behavioral|Counter Attitudinal Therapy|8 weekly 60 minute sessions of dissonance-based treatment wherein women with any eating disorder complete verbal, written, and behavioral activities.
15950416|NCT03261050|Behavioral|Interpersonal Therapy|8 weekly 60 minute sessions of interpersonal-based treatment wherein women with an eating disorder complete verbal, written, and behavioral activities.
15950417|NCT03261037|Other|Spirometry|Daily spirometry will be conducted by the participant at home using the study kit provided. Spirometry assessments (FVC) will be conducted at approximately the same time each day with the participant in a seated position. Additionally, site spirometry will also be performed during pre-diagnosis assessment period, on the day of diagnosis, post-diagnosis assessment period, and at end of study.
15950418|NCT03261037|Other|Accelerometry|Daily physical functional capacity assessments (e.g., steps per day, calorie expenditure) will be measured on an ongoing basis using the accelerometry device provided.
15950419|NCT03261037|Other|6MWT|The 6MWT will be performed only at sites where a formalized process is available and the test can be performed under safe conditions, during pre-diagnosis assessment period, on the day of diagnosis, post-diagnosis assessment period, and at end of study.
15950420|NCT03261024|Device|Friction mechanics|Nickel Titanium will be extended from the hook between the lateral incisors and canines to the first molar bands, to allow frictional en-masse retraction of anterior segment.
15950421|NCT03261024|Device|Frictionless mechanics|T-loops retraction arch will be placed distal to the upper canines and cinched distal to the first molar bands, to allow frictionless en-masse retraction of anterior segment.
15950422|NCT03261011|Biological|AK-104|Subjects will receive AK104 by intravenous administration.
15950423|NCT03260998|Diagnostic Test|electrocardiogram|measurment of QT dispersion and corrected QT and other electrocardiogram changes
15950424|NCT03260985|Other|Feedback Report|A report of the data from the comprehensive neuroscience assessment is provided to the patient's care team.
15950425|NCT03260972|Drug|Chloroprocaine Hcl 2% Inj|20 mls of Chloroprocaine Hcl 2% Inj (1 vial containing 400mg/20 mls of chloroprocaine) will be instilled into the abdomen prior to fascia closure.
15950426|NCT03260972|Drug|Normal saline|20 mls of normal saline will be instilled into the abdomen prior to fascia closure.
15950427|NCT03260959|Behavioral|Interview by hierarchical evocation's Method|Interview to describe the experience of the man during the announcement of a pregnancy that it is expected or not.
15950428|NCT03260946|Other|Complementary medicine use|The prevalence of complementary medicine use
15950429|NCT03260933|Other|No intervention given. This is a qualitative interview study|This is a qualitative interview study
15950430|NCT03260920|Drug|Syntocinon|Intranasal Oxytocin
15950431|NCT03260907|Procedure|Electroacupuncture|The treatment is to be applied twice a week for acupuncture points(unilaterally at CV3, CV4, GV20 and bilaterally at KI3, SP6), used for all the patients assigned to this group. Disposable, sterilized, filiform acupuncture needles manufactured is to be used. An electric acupuncture device (CellMac STN-110, Stratek Co, Republic of Korea) will be connected to the CV3-CV4, KI3-SP6 acupoints and deliver stimulation with a 2-Hz frequency, asymmetric bimodal pulse, continuous wave mode, maximum intensity below the threshold (7.6~13.9mA).
15950432|NCT03260907|Procedure|Acupuncture|The treatment is to be applied twice a week for acupuncture points(unilaterally at CV3, CV4, GV20 and bilaterally at KI3, SP6), used for all the patients assigned to this group. Disposable, sterilized, filiform acupuncture needles manufactured is to be used.
15950433|NCT03260894|Drug|Pembrolizumab|Pembrolizumab 200 mg administered intravenously every 3 weeks.
15950434|NCT03260894|Drug|Epacadostat|Epacadostat 100 mg administered orally twice daily.
15950435|NCT03260894|Drug|Sunitinib|Sunitinib 50 mg administered orally once daily; 4 weeks on, 2 weeks off for 6-wk cycle.
15950436|NCT03260894|Drug|Pazopanib|Pazopanib 800 mg administered orally once daily.
15950437|NCT03260881|Drug|Liraglutide Pen Injector [Victoza]|Study subjects will be randomized in two groups of 20 patients to receive additional liraglutide, (L-group) or to remain on current treatment or placebo (D-group).
15950438|NCT03260881|Drug|matching liraglutide-placebo pre-filled pens|Study subjects will be randomized in two groups of 20 patients to receive additional liraglutide, (L-group) or to remain on current treatment or placebo (D-group).
15950553|NCT03259906|Procedure|posterior osteosynthesis|Osteosynthesis using a posterior plate
15950439|NCT03260868|Drug|Insulin glargine, 300 units per milliliter (U/mL)|Self-administered subcutaneous injection using prefilled pen once daily for 24 weeks. Dose titration to achieve fasting self-monitoring of plasma glucose (SMPG) level between 80 and 130 milligram per deciliter (mg/dL).
15950440|NCT03260868|Drug|Background therapy: Rapid Acting meal time insulin analogs (Humalog, Novolog or Apidra)|Subcutaneous injection.
15950441|NCT03260855|Other|Questionnaires/Scales|Scale of Fear of Cancer Recurrence Inventory, Hospital Anxiety and Depression Scale, Evaluation of stress and life quality.
15950442|NCT03260855|Other|Human blood sample|The intervention is based on blood test.
15950443|NCT03260842|Diagnostic Test|Bio-Specimen Collection|Collection of bio-specimens and observation over time.
15950444|NCT03260829|Drug|vitamin C|25 IU of vitamin C injected intraepidermally for 6-8 visits till eruption achieved
15950445|NCT03260816|Behavioral|Internet-delivered Parent-Child Interaction Therapy (I-PCIT)|Families assigned to the Internet-delivered Parent-Child Interaction Therapy (I-PCIT) group will receive Internet-delivered weekly sessions of a short-term parent-training intervention emphasizing positive attention, consistency, problem-solving, and communication. Using videoconferencing, webcams, and wireless Bluetooth earpieces, I-PCIT therapists provide in-the-moment feedback to parents during live parent-child interactions.
15950446|NCT03260816|Other|Referrals as Usual (RAU)|Families assigned to RAU will participate in services referred by their Early Steps team, as per usual care.
15950447|NCT03260803|Drug|Oligopin|Oligopin ,150 mg ,once daily, 12 week
15950448|NCT03260803|Drug|Placebo|Placebo,150 mg ,once daily, 12 week
15950449|NCT03260790|Biological|PCV13|Single 0.5 ml dose of PCV13 administered via intramuscular injection
15950450|NCT03260790|Biological|PPSV23|Single 0.5 ml dose of PPSV23 administered via intramuscularly or subcutaneously
15950451|NCT03260777|Device|Trichoscopy|Trichoscopy (hair and scalp dermoscopy) is a noninvasive diagnostic tool that allows the recognition of morphologic structures not visible by the naked eye Structures which may be visualized by trichoscopy include hair shafts of different types, the number of hairs in one pilosebaceous unit, hair follicle openings (dots), the peri and interfollicular areas and the vasculature.
15950452|NCT03260764|Device|short term Multifocal Contact Lenses|wearing Multifocal Contact Lenses for one week
15950453|NCT03260764|Device|short term Bifocal Spectacles|wearing Bifocal Spectacles for one week
15950454|NCT03260764|Device|long term Multifocal Contact Lenses|wearing Multifocal Contact Lenses for one year
15950455|NCT03260764|Device|long term Bifocal Spectacles|wearing Bifocal Spectacles for one year
15950456|NCT03260751|Dietary Supplement|Zingiber officinale Roscoe extract 200 mg|2 cap/day, 800 mg/cap for 12 weeks
15950457|NCT03260751|Dietary Supplement|Placebo|Placebo for 12 weeks
15950458|NCT03260738|Device|Rehabilitation program with Poppy robot|Patient with a chronic low back pain. Usual 3 hours rehabilitation daily program, 5 days a week, 3 weeks. Among those 3 hours, patients receive 30 minutes of physical exercises dedicated to mobility of the spine supervised by robot Poppy.
15950459|NCT03260738|Other|Usual rehabilitation program|Patient with a chronic low back pain. Usual 3 hours rehabilitation daily program, 5 days a week, 3 weeks.
15950460|NCT03260725|Behavioral|Parent-Child Interaction Therapy (PCIT)|PCIT is a short-term intervention that incorporates principles of play therapy into behavioral parent training, drawing on attachment and social learning theories to emphasize positive attention, consistency, problem solving, and communication. Treatment is delivered in the clinic.
15950461|NCT03260725|Behavioral|Internet-delivered PCIT (I-PCIT)|I-PCIT is a short-term intervention that incorporates principles of play therapy into behavioral parent training, drawing on attachment and social learning theories to emphasize positive attention, consistency, problem solving, and communication. Treatment is delivered to families in their own home in real-time via videoconferencing over the Internet by a remote therapist.
15950462|NCT03260712|Drug|Pembrolizumab|The dose of pembrolizumab in this trial is 200 mg Q3W.
15950463|NCT03260712|Drug|Cisplatin|25mg/m2 cisplatin on days 1 and 8 of a 21 day cycle
15950464|NCT03260712|Drug|Gemcitabine|1000mg/m2 gemcitabine on days 1 and 8 of a 21 day cycle
15950465|NCT03260699|Device|OCSI Rehabilitator brace|Guardian Brace features the innovative Rehabilitator™ line of gait correcting, leg strengthening braces. Rehabilitator™ Knee Braces are clinically proven to reduce UNBRACED pain, strengthen the affected leg, and significantly improve function after only 90 days of brace wear.
15950466|NCT03260686|Other|experimental|video guide for upper limb exercise
15950467|NCT03260673|Other|specular microscope|The corneal endothelial cell density, variation in endothelial cell size (CV), percentage of hexagonal cells, and central corneal thickness(CCT) were recorded at baseline and at 3 months postoperatively.
15950468|NCT03260660|Device|Magnetic Resonance Elastography|The investigators plan to prospectively assess the agreement of liver stiffness measurements obtained using standard of care MR elastography techniques vs. MR elastography with varying amounts of imaging acceleration using compressed sensing in adult volunteers
15950469|NCT03260647|Other|Management algorithm for Malignant Bowel Obstruction|a proposed management algorithm for MBO has been developed to provide a pathway that safeguards quality and continuity of care for patients under a multidisciplinary team. It will engage key-stakeholders and foster an inter-professional approach. It incorporates an in-patient management algorithm and a novel nursing-led ambulatory management algorithm to supplement patient's medical management
15950470|NCT03260634|Drug|Voriconazole|
15950471|NCT03260621|Diagnostic Test|stress CMR|additional stress CMR to the established clinical diagnostics
15950472|NCT03260608|Behavioral|Telesupport|In the intervention will be carried out eight weekly phone calls of psychoeducation and support on the disease of the relatives approaching different themes.
15950473|NCT03260595|Drug|Crisaborole ointment 2%|Crisaborole ointment 2%
15950474|NCT03260595|Drug|Vehicle|Vehicle
15950510|NCT03260283|Drug|Pethidine hydrochloride|In Group I patients will be administered with low dose of pethidine hydrochloride (0.4 mgkg-1) diluted into normal saline up to 2 ml of total volume in order to perform subarachnoid anesthesia for urologic operations
15950511|NCT03260283|Drug|Ropivacaine HCl Inj 7.5 MG/ML|In Group II patients will be administered with 2 ml of ropivacaine (0.75%)
15950512|NCT03260283|Drug|Fentanyl|15 mcg of fentanyl will be added to the solution in order to perform subarachnoid anesthesia for urologic operations
15950475|NCT03260582|Other|LifePod®|The software is a web-based application designed to support persons adhering to lifestyle advice and medication. The patient can log information about lifestyle (i.e. diet, exercise, and smoking), measurements (i.e. weight, pulse and blood pressure), symptoms and medication and can review data in graphs displaying registered values in relation to recommended targets. The software provides positive feedback on healthy choices and gives general recommendations on exercise training, physical activity and healthy diet. Reminders are generated in the case of decreasing registrations. Finally, short text messages (SMS) will be sent out 2-3 times a week with tips on healthy lifestyle.
15950476|NCT03260569|Drug|Inhaled Nitric Oxide|Patients randomized to this arm will receive inhaled nitric oxide 20 parts per million.
15950477|NCT03260569|Drug|Placebo|Nitrogen plus oxygen
15950478|NCT03260556|Drug|Pirfenidone|Increasing doses
15950479|NCT03260556|Drug|Placebos|Increasing doses
15950480|NCT03260543|Dietary Supplement|fermented ginseng powder|tablets (2 tablets/day, 125 mg & 500 mg/day) for 12 weeks.
15950481|NCT03260543|Dietary Supplement|Placebo|Placebo for 12 weeks.
15950482|NCT03260530|Other|Locomotor evaluation|collection of parameters associated with walking and balance in patients with their usual prosthesis and then equipped with the new prosthesis
15950483|NCT03260530|Other|Questionnaires|Houghton's scale, PPA-LCI, ABC, QEP, SF-12, SAT-PRO, ESAT
15950484|NCT03260517|Device|Medtronic Coronary Drug-Coated Balloon Catheter|Medtronic Paclitaxel Coronary Drug-Coated Balloon Percutaneous transluminal coronary angioplasty
15950485|NCT03260504|Biological|Aldesleukin|Given SC or IV
15950486|NCT03260504|Biological|Pembrolizumab|Given IV
15950488|NCT03260478|Procedure|Red Blood Cells Transfusion|Transfusion of packed red blood cells unit(s).
15950489|NCT03260465|Device|seleXys PC|Total hip arthroplasty using the seleXys PC cup
15950490|NCT03260465|Device|RM|Total hip arthroplasty using the RM cup
15950491|NCT03260452|Procedure|Abdominal subcutaneous biopsies and Blood test|Abdominal subcutaneous biopsies and blood test for each volunteer.
15950492|NCT03260439|Drug|Tramadol|Children receive 0.1% BPV non-adrenalinated 0.5% / kg on each side with tramadol 2mg / Kg (G1: GroupBT ). Postoperativ analgesia was assessed by: the modified OPS scale at waking (H0), 1st (H1), 2nd (H2), and 24th (H24) PO hour at home, by the number of analgesic The hospital and home, and by the time of the first demand analgesic.
15950493|NCT03260439|Drug|Placebo|Children receive 0.1% BPV non-adrenalinated 0.5% / kg on each side with saline serum at the same volume (G2: Group B or control). Postoperativ analgesia was assessed by: the modified OPS scale at waking (H0), 1st (H1), 2nd (H2), and 24th (H24) PO hour at home, by the number of analgesic The hospital and home, and by the time of the first demand analgesic.
15950494|NCT03260426|Dietary Supplement|Clear Liquids|Clear liquids on postoperative day zero immediately upon return to the floor and subsequent days' advancement of enteral diet to regular diet is as per discretion of the attending physician.
15950495|NCT03260426|Dietary Supplement|Regular Solid|Regular diet from postoperative day zero immediately upon return to floor and onwards
15950496|NCT03260426|Device|Abstats|Intestinal rate measured by Abstats™ in patients offered immediate solid versus clear liquids after colorectal surgery
15950497|NCT03260400|Device|a bipolar percutaneous intramuscular electromyography electrode|The device, a bipolar percutaneous intramuscular electromyography electrode, is intended for use in upper-limb amputation patients who have received the regenerative peripheral nerve interface surgical procedure, in order to enable the use of advanced prosthetic arms and hands.
15950498|NCT03260387|Procedure|TPIAT|The entire pancreas is removed to treat the pain of chronic pancreatitis, and the islets are infused back into the patient to reduce diabetes risk after surgery.
15950499|NCT03260374|Device|Electric compound action potential|The electrically evoked compound action potentials, which are closely related to the electrically evoked brainstem responses, would also show a similar correlation with the behavioral threshold. Determining threshold levels requires subjective responses to a series of sophisticated psychophysical percepts. This is often difficult for cochlear implant patients. However, the neural response telemetry system renders possible the measurement of the compound action potential threshold .
15950500|NCT03260374|Device|electric stapedial reflex threshold|electric stapedial reflex threshold measurements are performed using the same software platform and electrical stimulus utilized for fitting the cochlear implant . Thus, stimulus parameters, including pulse duration and repetition rate, can be identical to those used to obtain behavioral judgments for psychophysical levels
15950501|NCT03260374|Device|electric auditory brain stem response|For most implant recipients , even the first introduction of electric stimulation from a cochlear implant evokes activity in the auditory brainstem , which can be measured as clear electric auditory brain stem response waveforms . Therefore the electric auditory brain stem response test can be used in the functional evaluation of the auditory system between the time of initial implant activation and after chronic cochlear implant use
15950502|NCT03260361|Other|Hypnosis, kinesitherapy, MEOPA|classical intervention
15950503|NCT03260361|Other|Usual practice|Usual practice with treatments and physio
15950504|NCT03260335|Behavioral|Anxiety management strategy|Anxiety management strategy as per standard care plan
15950505|NCT03260322|Drug|ASP8374|intravenous
15950506|NCT03260322|Drug|Pembrolizumab|intravenous
15950507|NCT03260309|Procedure|Semi-closed loop infusion system tactic.|"Semi -closed loop infusion system tactic.Use volume loading test twice (before surgery and 12hrs postoperatively). Computer provides advisory hypotension treatment algorithm. Computer provides advisory anemia treatment algorithm. Programmed iv fluid and blood infusions system ,,Belmont Rapid Infuser and programmable syringe pump for adrenaline infusion."
15950508|NCT03260309|Procedure|Routine infusion therapy tactic|Routine re-hydration bolus before surgery. Routine treatment of hypotension. Routine treatment of anemia.
15950509|NCT03260296|Other|self-administered structured questionnaire|"Data will be collected by self-administered structured questionnaire. The aim of the study and the way of filling the questionnaire will be explained to the students, and then he/she fills the questionnaire by him/her self.
~The questionnaire will assess smartphones addiction and some of its associated factors and its health consequences"
15950513|NCT03260270|Diagnostic Test|color doppler ultrasound|All patients are going to be examined by color Doppler ultrasound and the high risk patients are going to be examined by direct MDCT venography .
15950514|NCT03260257|Other|Neurofeedback|Neurofeedback (NFB) will be administered to improve gamma band response. NFBs effects will be measured on gamma coherence and working memory.
15950515|NCT03260244|Procedure|cardiac mapping and radiofrequency ablation procedure|"It is a minimally invasive procedure which can be performed using either general or conscious sedation. During catheter ablation, catheters (narrow, flexible tubes) are inserted into a blood vessel, often through a site in the groin (upper thigh) or neck, and guided through the vein until they reach the heart. Small electrodes on the tip of the catheters stimulate and record the heart's activity. This test, called an electrophysiology study (EPS), allows the doctor to pinpoint the exact location of the short circuit. Another word for pinpointing the exact location of the short circuit is 'mapping', for which precision is a key requirement to maximize a successful outcome.
~Once the location is confirmed, the short circuit is either destroyed (to reopen the electrical pathway) or blocked (to prevent it from sending faulty signals to the rest of the heart)."
15950516|NCT03260231|Dietary Supplement|Milled seed mix|Dietary intervention with or without seed mix
15950517|NCT03260205|Drug|Placebo|Placebo matching to SPD489 (Lisdexamfetamine dimesylate) capsule for 6 weeks.
15950518|NCT03260205|Drug|SPD489 (Lisdexamfetamine dimesylate)|SPD489 capsule in a 5:5:5:5:6 ratio to 5, 10, 20, 30 mg orally once daily for 6 weeks.
15950519|NCT03260205|Drug|SPD489|SPD489
15950520|NCT03260179|Drug|AL3810|Fasting，oral ，4w on or 3w on/1w off
15950521|NCT03260179|Drug|AL3810|Fasting，oral ，4w on or 3w on/1w off
15950522|NCT03260179|Drug|AL3810|Fasting，oral ，4w on or 3w on/1w off
15950523|NCT03260166|Drug|nicotinamide|Drug: nicotinamide; Pharmaceutical form: tablet; Route of administration: oral
15950524|NCT03260153|Drug|Deproteinised Calf Blood Serum Injection|
15950525|NCT03260153|Drug|Placebo (Sodium Chloride)|
15950526|NCT03260140|Behavioral|behavioral lifestyle intervention|The investigators will provide participants with the behavioral lifestyle intervention
15950527|NCT03260127|Behavioral|Computerized executive function training plus CPT (CEFT-CPT)|Participants randomized to the CEFT-CPT arm will receive 6 weeks of computerized executive function training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)
15950528|NCT03260127|Behavioral|Word game training plus CPT (WT-CPT)|Participants randomized to the WT-CPT arm will receive 6 weeks of computerized word game training and then 6 weeks of standard Cognitive Processing Therapy for PTSD (total of 12 sessions)
15950529|NCT03260114|Other|Personal Activity Intelligence|Participants randomized to the PAI eHealth program will be given a Mio Slice wristband (http://www.mioglobal.com/pai/), to measure the heart rate for calculating PAI. A weekly PAI of 100 can be achieved by a combination of different exercise intensities and the participants will, at any time, get information from the device (Mio Slice) (and the PAI App if they chose to use that as well) regarding how many minutes at specified heart rates is needed to achieve the weekly goal of 100 PAI. Participants will receive automatic feedback on a daily basis, and data will be automatically recorded on a secured server.
15950530|NCT03260101|Other|non intervational|Subjects who completed ApoGraft-01 study (through 180 days post-transplantation) and have signed informed consent for this follow-up study will be eligible to enroll. Subject will attend 4 in-clinic visits, once every 6 months up to 2 years post transplantation, and will undergo the following evaluations: acute and chronic graft versus host disease (GvHD) assessments, survival status (overall, relapse-free), disease status (disease relapse/recurrence)
15950531|NCT03260088|Diagnostic Test|Immunoglobulin G4|IgG4 will be purified from pleural fluids by diethylaminoethyl (DEAE)-cellulose ion exchange nephlometry
15950532|NCT03260075|Other|cat|Cat living at the ward
15950533|NCT03260062|Behavioral|Parent-Child Early Approaches to Raising Language Skills|The PEARLS intervention will teach parents evidence-based language strategies and sensitive parenting (e.g., warmth, respect for autonomy, linguistic stimulation) to promote language development in young deaf children with cochlear implants (CI).
15950534|NCT03260062|Other|Standard Care Speech therapy|Families will participate in auditory-verbal therapy, which is the standard speech therapy with children with hearing loss.
15950535|NCT03260049|Procedure|pars plana vitrectomy|pars plana vitrectomy
15950536|NCT03260023|Biological|TG4001|PhIb: Dose escalation PhII: Established RP2D for TG4001
15950537|NCT03260023|Drug|Avelumab|Anti PD-L1
15950538|NCT03260010|Drug|Fosfomycin|Infectofos 5 g
15950539|NCT03259997|Dietary Supplement|Probiotic supplement|Probiotic supplement
15950540|NCT03259997|Dietary Supplement|Placebo|Placebo
15950541|NCT03259971|Dietary Supplement|Probiotic-Lactobacillus plantarum PS128|Probiotic supplement of Lactobacillus plantarum PS128 , 1 tablet , twice a day , 12 hrs apart, lasting 2 months for Tic disorders and 4 months for Rett syndrome
15950542|NCT03259971|Dietary Supplement|Placebo|placebo , 1 tablet , twice a day , 12 hrs apart, lasting 2 months for Tic disorders and 4 months for Rett syndrome
15950543|NCT03259958|Drug|Donepezil TDS|Donepezil Hydrochloride Transdermal Delivery System
15950544|NCT03259958|Drug|Aricept|Aricept Tablet
15950545|NCT03259945|Other|Data collection|demographic and clinical data
15950546|NCT03259945|Other|Review of ECGs|nature and frequency of proven conduction disorders
15950547|NCT03259932|Other|no physical activity|no physical activity
15950548|NCT03259932|Other|physical activity|Rehabilitation program will start 4 weeks after discharge from acute care (S4), for a duration of 8 weeks (3 sessions / week). Physical training will include aerobic exercises 30-60 minutes at 50-80% of HRmax, associated with muscle building exercises in circuit training (20 min), and balance and flexibility exercises.
15950549|NCT03259919|Drug|Metformin|Metformin 850 mg x 1 per day for the first week, and 850 mg x 2 per day for the rest of the study period.. Orally. From inclusion (before gestational week 8) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study. In addition 1 mg tablet of folate and one daily multivitamin tablet.
15950550|NCT03259919|Drug|Placebo|Placebo, 2 tablets x 1 daily for the first week, and 2 tablets x 2 for the rest of the study period.Orally. From inclusion (that is before gestational week 12) to delivery. Verbal and written diet and lifestyle advices at inclusion to the study. In addition 1 mg tablet of folate and one daily multivitamin tablet.
15950554|NCT03259906|Procedure|Anterior osteosynthesis|Osteosynthesis using an anterior plate
15950555|NCT03259893|Other|AliveCor mobile ECG cardiac monitor|AliveCor mobile ECG cardiac monitor is capable of providing real-time heart telemetry using a smart phone. Participants will be instructed to transmit rhythm data twice weekly and during symptomatic AF.
15950556|NCT03259893|Behavioral|AF Program|The AF program includes a bundle of sub-interventions that target specific AF risk factors including hypertension, obesity, physical inactivity, sleep hygiene, and smoking. Participants randomized to the intervention group 2 will undergo counseling by the nurse and guided through the structured, goal-directed AF program. Each participant will receive an AliveCor cardiac monitor which is capable of providing real-time heart telemetry using a smart phone.
15950557|NCT03259893|Other|Standard of care|Guideline-directed medical therapy according to clinical standard practice at Boston Medical Center.
15950558|NCT03259867|Drug|Opdivo Injectable Product or Keytruda Injectable Product|a PD-1 immune check inhibitor per Investigator decision
15950559|NCT03259867|Combination Product|Trans-arterial tirapazamine embolization|Embolization with Lipiodol and Gelfoam
15950560|NCT03259854|Device|non invasive mechanical ventilation in pediatrics|use of non invasive mechanical ventilation in pediatrics after successful weaning from invasive mechanical ventilation
15950561|NCT03259854|Device|oxygen mask|use of oxygen mask after successful weaning from invasive mechanical ventilation
15950562|NCT03259841|Other|Ultrasound assessment of gastric contet|Ultrasound assessment of gastric content is performed in fasted patient undergoing cholecystectomy.
15950563|NCT03259828|Radiation|Adjuvant image-guided radiotherapy|Image-guided adjuvant radiotherapy to the sigmoid colon surgical tumor bed and pelvic regional lymph nodes: 45-50.4 Gy in 1.8 Gy/fraction
15950564|NCT03259815|Procedure|P.I.O.S.|Physiologically-Guided Incremental Optimisation Strategy
15950565|NCT03259815|Diagnostic Test|Pre and post-PCI coronary physiology measurements|Pre and post-PCI coronary physiology measurements will be performed but not disclosed to the operator
15950566|NCT03259789|Drug|Bexagliflozin tablets, 20 mg|Each subject will receive bexagliflozin, 20 mg once daily for the duration of the study.
15950567|NCT03259789|Drug|Bexagliflozin tablets, placebo|Each subject will receive placebo (inactive tablet) once daily for the duration of the study.
15950568|NCT03259789|Drug|Bexagliflozin tablets, 20 mg|Each subject will receive bexagliflozin, 20 mg once daily for the duration of the study.
15950569|NCT03259776|Other|Qualitative interviews and questionnaire survey|Qualitative interviews and questionnaire survey
15950572|NCT03259750|Other|Foot and Ankle Ability Measure Turkish version (FAAM-T) questionnaire|Self reported outcome instrument
15950573|NCT03259711|Drug|Hormonal therapies L02 in the ATC classification|Hormonal therapies L02 in the ATC classification
15950577|NCT03259685|Other|710 ml of regular soft drinks, taken daily for 10 weeks|Subjects will consume regular soft drinks to test if there is a significant difference on the impact on gut microbiota composition and metabolic syndrome parameters between this treatment and the active treatments (diet and stevia beverages).
15950578|NCT03259685|Other|710 ml of diet soft drinks, taken daily for 10 weeks|Subjects will consume diet soft drinks during 10 weeks to test the possible effects of aspartame/acesulfame-K sweetened beverages on gut microbiota composition and on metabolic syndrome parameters.
15950579|NCT03259685|Other|710 ml of stevia-sweetened soft drinks, taken daily for 10 weeks|Subjects will consume soft drinks containing stevia during 10 weeks to test the possible effects of steviol glycosides sweetened beverages on gut microbiota composition and on metabolic syndrome parameters.
15950580|NCT03259672|Drug|Sevoflurane|Sevoflurane was used as a maintenance anesthetic agent.
15950581|NCT03259672|Drug|Desflurane|Desflurane was used as a maintenance anesthetic agent.
15950582|NCT03259659|Other|ECG recording, inflammatory cytokines, microbiota, ulcerative colitis disease activity index|In this study, an electrocardiogram signal will be recorded for 30 min in the fasting state, and blood samples for inflammatory cytokines analysis (7 ml) will be taken at the end of the ECG recording; fecal samples will be taken on the experimental day before the study. In addition, ulcerative colitis disease activity index will be assessed using the Mayo scoring system.
15950583|NCT03259646|Behavioral|Universal Education|Clinic provider/staff training on implementing universal education into clinical practice to: 1.) provide all women information about IPV/SA, harm reduction, and available safety resources; 2) provide trauma-informed counseling to women who disclose IPV/SA; includes access to the myPlan safety decision aid to develop a tailored safety action plan; 3) provide warm referrals in partnership with local domestic violence and sexual assault (DV/SA) advocacy agencies; 4) integrate documentation and quality improvement templates and measures into clinical settings.
15950584|NCT03259633|Drug|Selumetinib|open-label, single-arm, multicenter intermediate access protocol
15950585|NCT03259620|Drug|CLS006|Furosemide Topical Gel
15950586|NCT03259620|Drug|CLS006 Vehicle|Vehicle Topical Gel
15950587|NCT03259607|Drug|Nicorette Extra Mint 2 mg Gum|A single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.
15984395|NCT03005002|Biological|Tremelimumab|Given IV
15950588|NCT03259607|Drug|Nicorette Mint 2 mg Gum|A single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.
15950589|NCT03259607|Drug|Nicorette Extra Mint 4mg Gum|A single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.
15950590|NCT03259607|Drug|Nicorette Mint 4 mg Gum|A single dose of one nicotine gum will be placed on the tongue to be chewed every 2 seconds for 30 minutes.
15950591|NCT03259594|Procedure|Laparoscopic deroofing|The classic treatment of patients with simple renal cysts is deroofing, which can be performed by open surgery or laparoscopy. Laparoscopic deroofing is an effective minimally invasive approach and has gained popularity.
15950592|NCT03259594|Drug|100 g of amino acids supplementation|intravenous supplementation with 100 g of amino acids 2 day before laparoscopic deroofing.
15950593|NCT03259581|Combination Product|Transarterial chemoembolization|Delivery of lipiodol, chemotherapy (Deoxyrubicin), and particles (embosphere particles) to the arteries feeding hepatocellular carcinoma. While both chemotherapy and particles are delivered this is a single procedure in which the chemotherapy is delivered followed immediately by particles.
15950594|NCT03259568|Device|Repetitive TMS|1-10 Hertz rTMS will be administered
15950595|NCT03259555|Drug|Brexpiprazole|Brexpiprazole was administered orally with flexible dosing from 2 to 4 mg/day; titrated to a maximum of 4 mg/day for 3 weeks.
15950596|NCT03259555|Drug|Placebo|Administered orally daily for 3 weeks.
15950597|NCT03259542|Drug|Mifepristone 300 MG|mifepristone 300 MG (4 tablets) orally for a total of 1200 mg a day for 14 days; then mifepristone 300 mg (3 tablets) orally for a total of 900 mg a day for 28 days
15950598|NCT03259542|Drug|Itraconazole 100 MG|itraconazole 100 MG (2 capsules) orally for a total of 200 MG for the last 14 days of mifepristone dosing
15950599|NCT03259529|Drug|Bendamustine hydrochloride|70 mg/m2 by intravenous (IV) infusion for up to 2 cycles
15950600|NCT03259529|Drug|Gemcitabine 500 mg|500 mg/m2 by intravenous (IV) infusion on day 1,8,15 for up to 2 cycles
15950601|NCT03259529|Drug|Gemcitabine 700 mg|700 mg/m2 by intravenous (IV) infusion on day 1,8,15 for up to 2 cycles
15950602|NCT03259529|Drug|Gemcitabine 1000 mg|1000 mg/m2 by intravenous (IV) infusion on day 1,8,15 for up to 2 cycles
15950603|NCT03259529|Drug|Nivolumab|1 mg/kg by intravenous (IV) infusion on day 1,15 for up to 2 cycles
15950604|NCT03259529|Drug|Rituximab|375 mg/m2 by intravenous (IV) infusion on day 0 for up to 2 cycles
15950605|NCT03259516|Drug|Nivolumab|1 mg/kg by vein on Days 1 and 15 of a 28 day cycle
15950606|NCT03259516|Drug|Azacitidine|75 mg/m2 subcutaneously on Days 1-7 of a 28 day cycle
15950607|NCT03259516|Drug|Fludarabine|25 mg/m2 by vein on Days 1, 2 and 3 of a 28 day cycle. Dose reduction to 15 mg/m2 is permitted in cases of grade 4 hematological toxicity after first cycle.
15950608|NCT03259516|Drug|Cyclophosphamide|300 mg/m2 by vein on Days 1, 2 and 3 of a 28 day cycle.
15950609|NCT03259516|Drug|Cytarabine|10 mg/m2 subcutaneously two times a day on Days 1-10 of a 28 day cycle
15950610|NCT03259516|Drug|all trans retinoic acid|45 mg/m2 per os daily during the whole course of treatment
15950611|NCT03259516|Drug|Sildenafil|20 mg per os three times a day during the whole course of treatment
15950612|NCT03259516|Drug|Melphalan|2 mg per os daily during the whole course of treatment
15950613|NCT03259503|Drug|Busulfan|Given IV
15950614|NCT03259503|Drug|Gemcitabine|Given IV
15950615|NCT03259503|Drug|Melphalan|Given IV
15950616|NCT03259503|Drug|Olaparib|Given PO
15950617|NCT03259503|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo peripheral blood stem cell transplant
15950618|NCT03259503|Other|Pharmacokinetic Study|Correlative studies
15950619|NCT03259503|Biological|Rituximab|Given IV
15950620|NCT03259503|Drug|Vorinostat|Given PO
15950621|NCT03259490|Drug|Empagliflozin/linagliptin/metformin HCl|Once daily
15950622|NCT03259490|Drug|Empagliflozin|Once daily
15950623|NCT03259490|Drug|Linagliptin|Once daily
15950624|NCT03259490|Drug|Metformin HCl|Once daily
15950625|NCT03259477|Procedure|precise segmental renal arterial clamping|Precise segmental renal artery clamping eliminates global renal ischemia by performing highly selective clamping of single or multiple segmental arteries.
15950626|NCT03259477|Procedure|laparoscopic partial nephrectomy|Laparoscopic partial nephrectomy (LPN) has been widely adopted as a minimally invasive nephron-sparing surgery for clinical T1 renal cell carcinoma(RCC).
15950627|NCT03259464|Drug|BI 685509|3 sequential dose groups
15950628|NCT03259464|Drug|Placebo|3 sequential dose groups
15950629|NCT03259451|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|
15950630|NCT03259438|Behavioral|Qigong|Qigong is a form of gentle mind-body movement that originates in China and has traditionally been used for healing purposes. It has been reported to improve energy levels, as well as strength and endurance and mental clarity and equanimity. This study will assess how a 10-week qigong intervention compares to an exercise-nutrition intervention in improving fatigue and vitality in female cancer survivors. On a secondary level, we will asses changes in underlying brain, heart, and peripheral dynamics that occur as a result of the qigong practice to develop a mechanistic understanding of qigong's efficacy.
15950631|NCT03259438|Behavioral|Healthy Living (CHIP + Pre-Train)|The Healthy Living active comparator intervention includes two components: plant based nutrition counseling via the Comprehensive Health Improvement Program (CHIP) and core strengthening exercises and light aerobic activity via the Pre-Train exercise program.
15950634|NCT03259412|Dietary Supplement|Fish Oil|Fish Oil Capsule
15950635|NCT03259412|Dietary Supplement|Placebo|Olive Oil capsule manufactured to mimic fish oil capsule
15950636|NCT03259399|Genetic|detection of genotype|detection of genotype by next generation sequencing
15950637|NCT03259386|Device|Microelectrode array|Microelectrode array implanted in area of amputation of either transradial or transhumeral amputees. This device is not designed to collect data on safety and effectiveness but rather, the device is a tool to assist in the sensory and motor properties of peripheral nerve stump fibers in amputees and is considered basic physiological research. This study was determined to be IDE exempt by the FDA; the study is considered basic physiological research.
15950638|NCT03259373|Behavioral|Early Intervention|"Letters to patients that (1) explain to the patient that he or she appears to have AF, characterize the risk of stroke, and emphasize that although there may be a medical reason, the patient does not seem to be on an anticoagulant and (2) encourage the patient to discuss this with his or her provider to ask if he or she might benefit from OAC therapy to prevent stroke.
~Early intervention letters to providers explain this project, the nature of the problem, and identify a list of the provider's patients who have been contacted, as the provider and patient letters will be sent at approximately the same time; describe evidence and guidelines regarding oral anticoagulation."
15950639|NCT03259373|Behavioral|Delayed Intervention|Delayed intervention letters to patients' providers, where they may be identified, that explain this project, the nature of the problem, and identify a list of their patients who are flagged as at risk for stroke and have not been treated with an oral anticoagulant; describe evidence and guidelines regarding oral anticoagulation.
15950640|NCT03259360|Behavioral|POP:|90 days of Facebook messaging, weekly live sessions targeting tobacco use and tailored to sexual and gender minority young adults
15950641|NCT03259360|Behavioral|TSP:|90 days of Facebook messaging, weekly live sessions targeting tobacco use
15950642|NCT03259347|Behavioral|Group-based Therapy|Young women with body dissatisfaction will be randomized to one of two conditions: 1) an educational-support group condition; or 2) a counter-attitudinal therapy condition. We will test if a brief dissonance-based eating disorder prevention program produces intervention effects when delivered to participants with sub-threshold and threshold eating disorders.
15950643|NCT03259334|Drug|Ontamalimab|Participants will receive 1 mL of SHP647 sterile aqueous buffered solution at an appropriate concentration to provide the intended dose of drug (25 or 75 mg).
15950644|NCT03259334|Other|Placebo|Participants will receive 1 mL of sterile aqueous buffered solution.
15950645|NCT03259308|Drug|Ontamalimab|Participants will receive 1 mL of ontamalimab sterile aqueous buffered solution at an appropriate concentration to provide the intended dose of drug (25 or 75 mg).
15950646|NCT03259308|Drug|Placebo|Participants will receive 1 mL of sterile aqueous buffered solution.
15950647|NCT03259295|Device|Digiclamp (Skin tag removal initial)|Skin tag will be assessed for size, location, and overall appearance. After assessment that the skin tag is not infected or possibly malignant, the site will be photographed, prepped with an antimicrobial solution, anesthetized, and removed using the Digiclamp. A bandaid will be applied to the site.
15950648|NCT03259295|Device|Digiclamp (Skin tag removal follow-up)|Site of skin tag removal will be photographed to document lesion recurrence and presence of scar tissue or hyperpigmentation. Subjects will be asked to complete a brief survey about their satisfaction with the use of Digiclamp.
15950649|NCT03259282|Biological|Analysis of gamma globulin|Electrophoresis of proteins
15950650|NCT03259269|Other|This is a non-intervention observational study|No applicable intervention; this is a secondary data analysis observational study.
15950651|NCT03259256|Procedure|Allogeneic transplantation of intrahepatic islet|Allogeneic transplantation of intrahepatic islet is one of the effective methods for diabetic therapy
15950652|NCT03259243|Drug|Bupivacaine Hydrochloride|0.5 Bupivacaine hydrochloride were port site infiltration preincision and preclosure injection
15950653|NCT03259230|Other|Blood Draws|
15950654|NCT03259230|Other|Data Collection|
15950655|NCT03259217|Drug|Stem Cell Product|Adipose tissue derived mesenchymal stem cell seeded in Curcumin loaded chitosan nanoparticles into collagen-alginate
15950656|NCT03259204|Device|Adjuvant IPC|This IPC-system delivers sequential circumferential compression. The IPC device is mobile and should therefore not restrict patient mobilization, but can be taken off if the patient wants to mobilize independently.
15950657|NCT03259191|Procedure|anti-reflux mucosectomy|Anti-reflux mucosectomy (ARMS) may be a new therapy for refractory gastroesophageal reflux disease (RGERD). The aim of the present study is to explore the safety and efficacy of ARMS.
15950658|NCT03259165|Drug|Nitrates|"For patients randomized to the Nitrate intense arm, the treatment protocol will be initiated and continued until there is a decrease in B-lines to ≤ 15 or 6 hours of care has been delivered, whichever comes first.
~Treatment protocol:
~IV furosemide (unless already given) (All patients receive at minimum 20 mg IV furosemide or equivalent)
~SL nitroglycerin (400 ucg) will be given every 5 minutes, a total of three times. (May be repeated) (Held if SBP decreases to < 120 mmHg)
~Reassessment every 2 hours. If LUS B-lines >15, repeat step 2. If < 15, stop algorithm."
15950659|NCT03259165|Drug|Loop Diuretics|"For patients randomized to the Diuretic intense arm, the treatment protocol will be initiated and continued until there is a decrease in B-lines to ≤ 15 or 6 hours of care has been delivered, whichever comes first.
~Treatment protocol:
~Patients receive 1 inch topical nitropaste
~IV Loop diuretic dose = patients total oral dose (max dose of 200 mg IV)
~Reassessment every 2 hours. If LUS B-lines >15, repeat step 2. If < 15, stop algorithm."
15950660|NCT03259152|Drug|Denosumab|Denosumab (trade names Prolia and Xgeva) is a human monoclonal antibody for the treatment of osteoporosis, treatment-induced bone loss, metastases to bone, and giant cell tumor of bone.Denosumab is a RANKL inhibitor, which works by preventing the development of osteoclasts which are cells that break down bone.
15950661|NCT03259139|Behavioral|Video games and violence|Participants will be randomly assigned to play a video game which contains either (1) no violent content, (2) violent content with swords, or (3) violent content with guns. The game, rated E, is age appropriate and modded to include guns in the appropriate condition.
15950662|NCT03259126|Device|SCUT|Two different home made curtains were attached to the angiographic table
15950663|NCT03259113|Device|Insertable cardiac monitor|Insertable cardiac monitor (SJM Confirm Rx) subcutaneously.
15950664|NCT03259100|Other|all the data collection have done by CDC.|In this study there was no intervention, just simple data collection via CDC.
15950665|NCT03259087|Drug|MK-3866|Single IV infusion of 200 mg administered over 30 minutes (±5 minutes) on Day 1 of each treatment period.
15950666|NCT03259074|Biological|Secukinumab|Eligible subjects are randomized to one of three treatment arms in a 1:1:1 ratio
15950667|NCT03259074|Biological|GP2017 (adalimumab biosimilar)|Eligible subjects are randomized to one of three treatment arms in a 1:1:1 ratio
15950668|NCT03259061|Device|Flexible fiberoptic nasopharyngoscopy|"Flexible fiberoptic nasopharyngoscopy (FFN) allows direct transnasal observation of the anatomy and dynamic activity of the velopharyngeal sphincter. Such observations can be recorded for permanent documentation by coupling FFN to a video camera with simultaneous audio recording. Numerous published reports discuss the advantages of FFN as a clinical method for evaluating velopharyngeal function during speech (10).
~Cephalometric analysis, is the clinical application of cephalometry. It is analysis of the dental and skeletal relationships of a human skull and is frequently used by dentists, orthodontists, and oral and maxillofacial surgeons as a treatment planning tool.
~Cephalometric analysis can also be applied for assessing the velopharyngeal structure and function. More specifically, velopharyngeal function in terms of its shape and mobility was analyzed quantitatively on the basis of cephalometric principle"
15950669|NCT03259048|Diagnostic Test|Abdominal ultrasound|Abdominal ultrasound will be used in the diagnosis of acute abdomen in pediatric group.
15950670|NCT03259035|Drug|Folfox Protocol|6 cycles of q2weekly FOLFOX, or
15950671|NCT03259035|Drug|Capox|4 cycles of q3weekly CAPOX
15950672|NCT03258996|Procedure|Modified vestibular incision subperiosteal tunnel access|"Single vertical mucosal incision, in the middel of the area to be treated, from which we began to lift a mucoperiosteal flap in a single plane.
~With a micro-scalpel intrasulcular incisions are made extending to the base of the papillas.
~Preparation of a tunnel in the same plane. Take a connective tissue graft on the same side of the palate. The connective graft is inserted through the vertical incision prepared with the aid of the suture.
~All is stabilized by means of suspensory sutures of coronal traction on each point of contact.
~Finally the vertical incision made is sutured."
15950673|NCT03258996|Procedure|Coronally advanced flap|"Oblique submarginal incisions in both interdental areas of each recession, which continue with the intrasulcular incision, one tooth extending on each side of the teeth to be treated.
~A partial-total-partial thickness flap is elevated in the coronal-apical direction.
~A vestibular mucosal dissection is performed to eliminate muscle tension. The remnant tissue of the anatomical interdental papillas is desepithelized. Take a CTG on the same side of the palate. The connective tissue graft is stabilized with resorbable suture over the recessions with suspensory sutures on the teeth.
~Finally, suspensory sutures with non-resorbable sutures are also used to achieve an accurate adaptation of the vestibular flap over the exposed root and stabilize each surgical papilla over each desepithelized interdental area."
15950674|NCT03258983|Other|Alpha-linolenic acid|Exposure to dietary intake of alpha-linolenic acid (ALA) will be assessed using a detailed food frequency questionaire filled in by participants included in the Diet, Cancer and Health cohort at baseline. Exposure to adipose tissue content of ALA will be determined by gas chromatography in all incident cases and in subcohort of 3500 participants randomly drawn from the total cohort.
15950675|NCT03258970|Other|Observational cohort study|taking vitamin supplements
15950676|NCT03258957|Other|Fresh Milk|Mothers will be asked to provide at least 1 feed of fresh milk (i.e. within 4 hours of milk expression) per day, other time, feed frozen milk
15950677|NCT03258944|Other|Breath-Stacking|Participants will be seated, with their elbows resting on the table, holding the face mask attached to a T-tube and a one-way valve. They will be instructed to inspire and force the expiration inside the mask. The training will be conducted three times a week for a period of four weeks, totaling twelve sessions. The breath-stacking application protocol will consist of three three-minute series, with a three-minute recovery interval between each series, obtaining a total time of fifteen minutes in each session.
15950678|NCT03258931|Drug|Crenolanib|Crenolanib will be administered orally
15950679|NCT03258931|Drug|Midostaurin|Midostaurin will be administered orally
15950680|NCT03258931|Drug|Cytarabine|100 mg/m² IV continuous infusion over 24 hours
15950681|NCT03258931|Drug|Duanorubicin|90 mg/m2 IV
15950682|NCT03258918|Behavioral|Low-Carbohydrate Diabetes Prevention Program|LC-DPP participants will be instructed to follow ad-libitum very low-carbohydrate, ketogenic diet, which restricts carbohydrate intake (not including fiber) to 20-35 grams per day with the goal of achieving nutritional ketosis. Participants will be encouraged to eat a normal amount of protein (roughly 80-120 grams per day) and to derive the remaining calories from fat. Allowable foods include: meats, fish, poultry, eggs, cheese, seeds, nuts, leafy greens, non-starchy vegetables, and some fruits.
15950683|NCT03258905|Behavioral|Grounding enhanced app|A mobile app that uses the Seeking Safety grounding chapter content, enhanced with features designed to create strong engagement and interactivity
15950684|NCT03258905|Behavioral|Grounding text-only app|A mobile app that uses the Seeking Safety grounding chapter content in text format only
15950685|NCT03258892|Other|Educational Intervention|Receive STG
15950686|NCT03258892|Other|Quality-of-Life Assessment|Ancillary studies
15950687|NCT03258892|Other|Survey Administration|Ancillary studies
15950688|NCT03258879|Procedure|Modified CSE|MCSE group: 1 ml of 0.25% bupivacaine will be injected intrathecally
15950689|NCT03258879|Procedure|Dural puncture epidural|DPE group: Dural puncture performed, but no medication will be injected intrathecally.
15950690|NCT03258866|Drug|Rituximab|given with a fixed dose of 100 mg administered as an intravenous infusion weekly (on day 1, 8, 15 and 22)
15950691|NCT03258866|Drug|Rituximab|given with a single dose of 375mg/m2
15950692|NCT03258853|Device|Bionic Pancreas|Bionic pancreas system: The bionic pancreas is an autonomous, self-learning system that requires only the subject's weight for initialization, and then autonomously adapts insulin dosing to maintain glycemic control. The bionic pancreas uses continuous glucose monitoring as input to the controller. The bionic pancreas can be used in a bi-hormonal configuration, administering both insulin and glucagon as well as an insulin only setting.
15950693|NCT03258853|Other|Usual Care|Subjects will remain on home insulin regimen (either insulin pump or injectable insulin). Subjects in usual care will wear a study CGM even if in typical care does not include CGM use.
15950694|NCT03258840|Dietary Supplement|EPA Supplement|EPA supplement, 4 × 500 mg softgel daily (2 g per day), 2 times a day, for 8 weeks.
15950695|NCT03258840|Dietary Supplement|EPA Placebo|EPA- placebo softgel (Containing 2 g edible paraffin oil), 4 × 500 mg softgel daily, 2 times a day, for 8 weeks.
15950696|NCT03258827|Procedure|Exercise with a towel|Exercise program composes with warm-up, strengthening exercise, cold-down, 60 minutes/time, 3 times/week. A towel is an important tool for exercise. Total duration of the program is 3 months.
15950697|NCT03258827|Procedure|Home-based exercise|Home-based program focuses on walking activity at fast speed, 3 times/week, 60 minutes/times. The total duration is 3 months.
15950698|NCT03258814|Behavioral|Active Supervised Training (AST)|The active supervised and standardized training consisted of 24 units of exercise within 20 weeks performed in certified training centers and was focused on back fitness, core strengthening and patient engagement to treat back pain and functional impairment.
15950699|NCT03258814|Behavioral|Standard of Care (SOC) Physiotherapy|Standard of care physiotherapy as used in this study included active as well as passive training and massages according to the physiotherapist discretion.
15950700|NCT03258788|Procedure|Biopsy and blood samples|"Archival tumour biopsies will be analysed for baseline PD-L1 expression. Some participants will have a biopsy before radiotherapy if the archival biopsy is not suitable.
~Participants will be required to undergo an additional mandatory biopsy of the irradiated site during the second week. Patients must have completed at least 1 week of the planned treatment before taking the biopsy.
~Participants will also be asked for consent to donate 50ml blood pre biopsy (at baseline and week 2) and at the end of radiotherapy; as well as 10ml blood before #2 radiotherapy and weekly throughout treatment."
15950701|NCT03258775|Other|water intake|After an overnight fast participants' RMR will be measured by indirect calorimetry for 30 minutes after which either a low (250ml) or high (500ml) dose of water will be consumed followed by an additional 90 minutes of indirect calorimetry. The test day will be repeated after 7-10 days with the second dose of water. The order in which the dose of water will be consumed will be randomized
15950702|NCT03258762|Drug|Pyrimethamine|Pyrimethamine will be available as 25 mg tablets. Subjects will be orally administered two pyrimethamine tablets on Day 1 in a fasted condition with 240 mL of water.
15950703|NCT03258762|Drug|Calcium folinate|Calcium folinate will be available as 5 mg tablets. Subjects will be orally administered three calcium folinate tablets on Day 1 along with pyrimethamine followed by once daily administration of calcium folinate until Day 8. Each administration will be with 240 mL water.
15950704|NCT03258749|Drug|Tiotropium|inhaled Tiotropium(18μg, qd)
15950705|NCT03258749|Drug|Formoterol|inhaled formoterol(4.5μg, bid)
15950706|NCT03258736|Procedure|inguinal hernia surgery|repair of inguinal hernia
15950707|NCT03258723|Behavioral|Lifestyle Intervention|"The lifestyle intervention consists of a series of workshops adapted from the East Harlem Partnerships for Diabetes Prevention that discuss diabetes prevention, finding and affording healthy foods, label reading, physical activity, planning a healthy plate, making traditional foods healthy and portion control.
~The newly launched East Harlem Diabetes Prevention (EHDP) project's mobile app, iHEED will be used by intervention participants to help reinforce the content they learn during the workshop series."
15950708|NCT03258723|Drug|Metformin|At 6 months, intervention participants who have not been able to lose weight or bring their HbA1c below the high risk range of 6% (determined by point-of-care testing) will have Metformin prescribed by their provider. Metformin will be prescribed at 500mg twice a day. If no change is seen at 12 months follow up, the dose will be increased to 850mg twice a day.
15950709|NCT03258710|Drug|Tenofovir Disoproxil Fumarate|Tenofovir Disoproxil Fumarate is a nucleos(t)ide analogue that inhibits HBV growth. All subjects will receive one tablet of TDF 300 mg once daily orally for 96 weeks.
15950710|NCT03258697|Drug|Levobupivacaine Hydrochloride|Different way of LevoBupivacaine injection
15950711|NCT03258684|Drug|Hydrocortisone, Vitamin C, and Thiamine|Intervention
15950712|NCT03258684|Other|Normal saline|Placebo
15950713|NCT03258671|Drug|EGFR-TK Inhibitor|·EGFR-TKI：gefitinib will be administered 250mg/d ivgtt qd; icotinib will be administered 150mg/d ivgtt tid;
15950714|NCT03258671|Radiation|Intensity Modulated Radiation Therapy|"High dose group：DTGTV=70Gy；
~first course radiotherapy：40Gy/20f/4w（DTPTV：36Gy/20f/4w）,2Gy/f/d；
~late course radiotherapy：1.5Gy/f、2f/d、interval≥6 hs、DTGTV=30Gy（DTPTV=27Gy）。
~Low dose group：DTGTV=50Gy;
~first course radiotherapy：32Gy/16f/3w（DTPTV为28.8Gy/16f/3w），2Gy/f/d；
~late course radiotherapy：1.5Gy/f、2f/d、interval≥6小时、DTGTV为18Gy（DTPTV为16.2Gy）。"
15950715|NCT03258658|Biological|Autologous Engineered Urethral Construct|urethral construct
15950716|NCT03258645|Drug|Dabigatran|Oral anticoagulant (NOAC) thrombin inhibitor
15950717|NCT03258632|Behavioral|Drinking Options - Motivate, Shared Decisions, Telemonitor (DO-MoST)|Patients will attend one 50-minute individual session with a Decision Coach (a trained clinical provider, e.g., MSW). Patients in DO-MoST will also attend 6 biweekly 15-minute telephone sessions from the same Decision Coach.
15950718|NCT03258619|Biological|Aldosterone / renin dosage|Plasma levels of aldosterone and renin
15950719|NCT03258619|Biological|Natriuresis|natriuresis levels
15950722|NCT03258580|Device|Medoc thermal stimulator|Heat pain stimulation for substudy 1
15950723|NCT03258580|Device|Electric shock stimulator|Electric pain stimulation for substudy 1
15950724|NCT03258580|Device|Cold water bath|Cold pain stimulation for substudy 1
15950725|NCT03258580|Behavioral|Pain assessment performance feedback|Participants in substudy 3's Feedback Group will be informed about their performance after every trial when making judgments about other people's pain.
15950726|NCT03258567|Biological|Nivolumab|Nivolumab, 480 mg IV every 4 weeks for up to 2 years in subjects with responding disease with clinical benefit if they are tolerating treatment
15950733|NCT03258541|Device|TraceIT®|This pilot study wishes to investigate feasibility and efficacy of the injected hydrogel spacers TraceIT® in sparing vagina/prostate in the treatment of rectal cancer patients.
15950734|NCT03258541|Radiation|Volumetric Arc Therapy (VMAT)|VMAT - fractionation Schedule : 1.8 Gy per fraction, one fraction per day, 5 fractions per week for the elective PTV and 2 Gy per fraction, one fraction per day, 5 fractions per week for the PTV-boost using a simultaneous integrated boost technique.
15950735|NCT03258541|Procedure|Surgery|Low anterior resection of the rectum: 8-10 weeks post-radiotherapy
15950736|NCT03258528|Behavioral|positioning|Positioning neonates for 6 hours either in right lateral position or supine position
15950737|NCT03258515|Drug|AZD6094 200 mg|A potent and selective small molecule mesenchymal epithelial transition (MET) kinase inhibitor with significant antitumor activity.
15950738|NCT03258515|Other|Placebo|AZD6094 matching placebo without any pharmacological activity.
15950739|NCT03258515|Drug|Moxifloxacin|A fluoroquinolone broad-spectrum antibiotic, produces a mild, but reproducible increase in QT interval corrected (QTc) in healthy normal participants at time to reach maximum concentration (tmax - approximately 2 hours (0.5 to 4 hours)). This effect is close to the ECG interval measured from the onset of the QRS complex (onset of the QRS complex to the J point) to the offset of the T wave (QT)/QTc effect that represents the threshold of regulatory concern, around 5 ms mean QTc interval prolongation.
15950740|NCT03258502|Drug|RV521|RV521 drug in capsules
15950741|NCT03258502|Drug|Placebo|Placebo in capsules
15950742|NCT03258489|Device|Transcutaneous nervous electric stimulation (TENS)|TENS (Frequency 10 Hz or 100Hz /duration 200μs, Endophasys nms 0501® model, KLD Biosystems, Amparo, SP, Brazil) will be applied with intensity between 1 to 60 mA and the current will be adjusted every 5 minutes at the sensory threshold level muscle contraction or according to the tolerance to the stimulus informed by the volunteers. TENS will be applied in bilateral paravertebral region of C7 to T4 or long the brachial plexus and sciatic plexus.
15950743|NCT03258489|Device|Interferential electrical stimulation (IES)|The IES (Endophasys nms 0501®, KLD Biosystems, Amparo, SP, Brazil) will be applied in continuous mode with biphasic pulses. Bipolar electrodes with slope of 1/5/1. The rest of the parameters will be set to 4000 Hz, AMF of 100 Hz and the AMF variation of 25 Hz. The effect of the current will be adjusted by the intensity, it should produce paresthesia stimuli, without pain and below the motor threshold. Adhesive electrodes (MultiStick®, Axelgaard Manufacturing CO, Ltd, Fallbrook, CA, USA) will be housed in the paravertebral region, between C7 (Channel 1) and T4 (Channel 2). (SANTOS et al., 2013)
15950744|NCT03258489|Device|TENS and IES Placebo|Same protocol without electrical output.
15950745|NCT03258476|Drug|Guanfacine Extended Release|Intuniv (guanfacine) is a prescription medicine used to treat attention deficit hyperactivity disorder (ADHD) in children who are at least 6 years old. An open-label trail of guanfacine extended release (GXR 1-4 mg/daily; Intuniv™) suggested benefits in improving behavioral and emotional regulation in children and adolescents with symptoms of traumatic stress. However, to date no controlled clinical trial has been completed assessing the effects of GXR on traumatic stress symptoms in youths
15950746|NCT03258476|Behavioral|Mindfulness Skills Therapy|Mindfulness is a therapy for anxiety and stress. Mindfulness forms of therapy involve regulation of attention, maintaining it in immediate experience, regardless of the valence and desirability of the experience. To reduce anxiety, Mindfulness encourages observing and accepting anxiety-related thoughts
15950747|NCT03258476|Drug|Placebo|Placebo oral capsule
15950748|NCT03258463|Other|Change in Texas Law|The change in Texan laws occurring from July 2013-January 2014
15950749|NCT03258450|Behavioral|Psycho-behavioural intervention arm (PBI)|The first session introduces the rationale of the intervention and is designed to encourage participants to recognize the autonomous role they can play in their health and well-being. Patients will be trained on breathing as a relaxation technique. The second session focuses on building behavioural skills to manage common symptoms for colorectal cancer patients. The third session focuses on cognitive strategies to address worries and existential distress. The last session focuses on maximizing social support and applying skills learned so far in dealing with loved ones. Participants will be provided an MP3 player that contains the relaxation exercise recording and a folder with summaries of the session content.
15950750|NCT03258437|Dietary Supplement|DA-9401|
15950751|NCT03258437|Dietary Supplement|Placebo|Placebo for 12 weeks.
15950752|NCT03258424|Drug|PTI-428|PTI-428 or placebo will be given QD for 14 days.
15950753|NCT03258424|Drug|Placebo|PTI-428 or placebo will be given QD for 14 days.
15950754|NCT03258411|Device|Rapid Expansion of palatal suture|
15950755|NCT03258398|Drug|eFT508|eFT508 will be taken orally (PO) twice a day (bid).
15950756|NCT03258398|Drug|Avelumab|Avelumab 10 mg/kg will be administered intravenously (IV) on Day 1 and once every 2 weeks (q2wk) thereafter
15950757|NCT03258385|Dietary Supplement|Vitamin B12 fortified UHT milk|Daily intake of 200 mL of UHT milk fortified with 100 µg vitamin B12
15950758|NCT03258385|Dietary Supplement|Plain UHT milk|Daily intake of 200 mL of plain UHT milk
15950759|NCT03258372|Drug|Mifepristone|Period 1: mifepristone 300 MG (1 tablet) for a total of 300 MG on Day 1 in Cohort 1; and mifepristone 300 MG (5 tablets) for a total of 1500 MG in Cohort 2; then Period 2: rifampin 300 MG (2 capsules) for a total of 600 MG daily for 14 days for both cohorts; then Period 3: mifepristone 300 MG (1 tablet) for a total of 300 MG on Day 1 in Cohort 1; and mifepristone 300 MG (5 tablets) for a total of 1500 MG in Cohort 2
15950760|NCT03258359|Biological|PACTN|To treat patients with MDS who have failed treatment with hypomethylating agents or have relapsed after treatment with hypomethylating agents or have declined hypomethylating therapy.
15950761|NCT03258346|Other|Inertial Load Cycling Training|Each session of training will require a total of 15 min with the total time actually exercising of only 60-120 sec. The first week will consist of performing 15 'sprints' on the ILE, beginning each sprint with 56 sec of rest. During week 2-5, subjects will rest 41 sec between sprints, completing 20 bouts. Finally, during weeks 6-10, subjects will take 26 s rest between sprints and complete 30 bouts).
15950762|NCT03258346|Dietary Supplement|Pomegranate Juice|Subjects will consume 8oz of pomegranate juice daily for duration of study.
15950763|NCT03258346|Dietary Supplement|Placebo|Subjects will consume 8oz of pomegranate juice daily, that has had the polyphenols removed.
15950826|NCT03257839|Device|Automated Whole Breast Ultrasound|Bilateral breast ultrasound performed as an adjunct to mammography.
15950764|NCT03258333|Procedure|aortic valve replacement|Standart AVR using stented stented bioprosthesis aortic valve reconstruction using autologus pericardium
15950765|NCT03258320|Drug|Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin|As preoperative neoadjuvant chemotherapy, drugss including Cabazitaxel, Docetaxel, Mitoxantrone or Satraplatin (CDMS) will be administered as a single agent performed 45 days before surgery：Cabazitaxel 25 mg/m2, Docetaxel 35 mg/m2, Mitoxantrone 4 mg/m2 or Satraplatin 80 mg/m2, through intravenous (IV) or oral (Satraplatin) administration. IV or oral administration once every 7 days, totally 4 cycles. There is a 17-day interval between the last dose and surgery.
15950766|NCT03258307|Other|Preoperative level|Blood sample
15950767|NCT03258294|Drug|Melatonin(Circadin®)|
15950768|NCT03258294|Drug|Placebo Oral Tablet|
15950769|NCT03258281|Drug|Evolocumab|Patients will receive evolocumab 420 mg administered subcutaneously
15950770|NCT03258281|Drug|Placebo|Patients will receive placebo administered subcutaneously
15950771|NCT03258268|Device|Standard of Care with EASY DSS|"The EASY DSS is a software tool designed to process and analyze data to facilitate individualized treatment suggestions for type 2 diabetes patients.
~Patients will receive standard of care with a board certified physician with EASY DSS.
~The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone."
15950772|NCT03258268|Other|Standard of Care without EASY DSS|"Patients will receive standard of care with a board certified physician without EASY DSS.
~The choice of treatment will be made by the investigator. In the investigational arm this will be based on the clinical judgment of the investigator supplemented with support from the EASY DSS and in the control arm this will be based on the clinical judgment of the investigator alone."
15950773|NCT03258255|Procedure|penil or pudendal nerve block in circumcision|regional analgesia methods during the circumsion nerve stimulator guided pudendal block performed by anesthesiologist/ penil block performed by surgeon before circumcision
15950774|NCT03258242|Drug|Keluo Xin capsule|four capsules at a time, three times a day, taken orally and consecutively for 24 weeks or 48 weeks.
15950775|NCT03258242|Drug|Placebo oral capsule|four placebo capsules at a time, three times a day, taken orally and consecutively for 24 weeks or 48 weeks.
15950776|NCT03258229|Dietary Supplement|Angelica gigas N. extract|capsules(2cap/d, 1,000mg/d) for 8 weeks.
15950777|NCT03258229|Dietary Supplement|Placebo|Placebo for 8 weeks
15950778|NCT03258216|Diagnostic Test|panendoscopy|panendoscopy
15950779|NCT03258216|Diagnostic Test|tongue image|capture tongue images by Automatic Tongue Diagnosis System
15950780|NCT03258203|Other|Preventing Overweight Using Novel Dietary Strategies|The study tests the effectiveness for weight loss and weight maintenance of four diets differing in macronutrient composition: moderate in fat (40% energy) with two different protein levels (15% and 25%), and low in fat (20% energy), also with 15% and 25% protein levels.
15950781|NCT03258190|Drug|Lime Powder Regimen|LPR and placebo were randomly given to subjects for 6 months
15950782|NCT03258177|Other|Virtual Visit|Participants will be given information about how to enroll in virtual care. Participants will use their own camera-enabled device with internet connection to see and speak to the medical professional in real-time and complete the virtual follow-up visit.
15950783|NCT03258164|Biological|ASC enriched lipofilling|Fat grafts enriched with ex vivo expanded ASC
15950784|NCT03258164|Biological|Standard Lipofilling|Non-ASC enriched fat grafts
15950785|NCT03258151|Genetic|detection of genotype|detection of genotype by next generation sequencing
15950786|NCT03258138|Behavioral|Health and wellness learning sessions|The health and wellness learning sessions provide a platform for concepts from a variety of health behaviour theories and CBT to be combined with evidence- and practice-based recommendations for healthy lifestyles. They provide the basis for participants' development of an individualized action plan. The sessions will last one hour and participants will receive them in a group setting, 18 times throughout the duration of the program. Specifically, the sessions will be delivered during weeks: 1-8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48.
15950787|NCT03258138|Behavioral|Brainstorming group sessions|The brainstorming group sessions allow for facilitated discussions where individuals explore barriers and facilitators to achieving their goals and provide an interpersonal component to the program through the building of social interactions. Participants will also receive help in finding community programs to support healthy lifestyles. These sessions will last one hour and participants will receive them in a group setting, 30 times throughout the duration of the program. Specifically, these sessions will be delivered during weeks: 9-11, 13-15, 17-19, 21-23, 25-27, 29-31, 33-35, 37-39, 41-43, 45-47.
15950788|NCT03258138|Behavioral|Individual sessions with a multidisciplinary health team|Monthly individual sessions with a family physician trained in medical CBT, a dietician and a physical therapist help individuals tailor their action plans and recommendations to their particular circumstances and provide supports based on their needs. The initial session will last 3 hours and occur at baseline. The follow-up sessions will last 1 hour.
15950789|NCT03258138|Behavioral|Health goal development|Participants in both arms will develop health goals. Several components of these goals will be measured throughout the study, including the stage of change, self-efficacy and actual goal achievement. In the more intensive program arm, participants will develop health goals and learn about how to meet those goals through the group and individual sessions. In the less intensive program arm, participants will receive support in developing health goals from a research assistant trained in theories of health behaviour and in goal setting at baseline, 3 months, 6 months, 9 months and 12 months. The initial goal setting session will be provided within a time period of 2 hours, and the follow-up sessions will be provided within one hour time periods.
15950790|NCT03258138|Behavioral|Physical activity and nutrition journals|Participants in both arm will be asked to maintain a physical activity journal and a nutrition journal for a week each every three months. These journals help participants reflect on current behaviours and areas for change.
15950823|NCT03257852|Other|Methotrexate therapy|MTX must have been continuously orally administered for at least 90 days prior to screening, with stable dosage for at least 28 days prior to screening, and will be continuously administered with the same dosage throughout the study period.
15950824|NCT03257839|Device|Routine Full-Field Digital Mammography|Routine screening mammography exam, CC + MLO views.
15984490|NCT03004339|Drug|Taclonex® Ointment|
15950791|NCT03258125|Genetic|real time PCR (rPCR)|A villus tissue (2.5 cm * 2.5 cm * 2.5 cm) will be cut off immediately from the center of placenta, avoiding the area of infarction, bleeding or calcification. After being washed with normal saline, the tissue will be preserved in liquid nitro¬gen at once for subsequent detection of miR-452 and MMP-9 expression by real time PCR (r-PCR). During this procedure total RNA will be extracted including miR-452 and mRNA of MMP-9. Then by reverse transcriptase RNA will be converted into DNA which will be amplification during the PCR, i.e. in real-time, and not at its end, as in conventional PCR. Expression of miR-452 and MMP-9 will be estimated and correlated with each other.
15950792|NCT03258112|Procedure|Radiofrequency cardiac catheter ablation|procedure used for ablation of ventricular arrhythmia using catheters introduced to target sites percutaneously through venous or arterial systems using radiofrequency power
15950793|NCT03258099|Genetic|detection of genotype|detection of genotype by next generation sequencing
15950794|NCT03258086|Diagnostic Test|blood sample test|blood sample will be taken from all diabetic children for assessment of vitamin D level
15950795|NCT03258073|Other|Medical simulation using scenario execution|Each team of students will be exposed to simulation two times in a semester totaling to four times a year. In a scenario execution, participants are placed in a simulated experience of a medical emergency. Participants are required to respond and their reactions are observed by the investigators. After the experience, participants will have a debriefing session to learn from their experience of handling this emergency.
15950796|NCT03258060|Procedure|Temporary pacing study|
15950797|NCT03258060|Radiation|Body Surface Mapping|
15950798|NCT03258047|Combination Product|CAR-T|CAR-T is a novel technique for cancer treatent, it includes procedures of modifying patients' T cells outside the body and re-transfuse these cells back into the human body to fight against the cancer cells.
15950799|NCT03258034|Drug|SPA|S1/Paclitaxel chemotherapy plus Apatinib S1:60mg twice daily(after the breakfast and supper) for two weeks, and then suspend for one week Paclitaxel:150mg/m2,iv, 3h, at day1 Apatinib:425mg once daily
15950800|NCT03258021|Device|TTFields|Tumor treating fields (TTFields) help slow down or stop glioblastoma cancer cells from dividing by disrupting dividing mechanism of cancer cells leading to apoptosis. TTFields are low-intensity, intermediate frequency, alternating electric fields delivered continuously through adhesive patches, called transducer arrays, to the area of the brain where the GBM tumor is located. These transducer arrays are applied to the scalp and are connected to the wearable and portable device. TTFields are approved for the treatment of newly diagnosed and recurrent GBM.
15950801|NCT03258008|Drug|Utomilumab|Utomilumab given by vein on Cycle 1 Day 1. Cycle 1-2 100 mg, Cycle 3-12 50 mg until progressive disease, toxicity, or 1 yr.
15950802|NCT03258008|Biological|ISA101b|ISA101b 100 mcg/peptide given subcutaneously every 4 weeks x 3 doses beginning cycle 1 day 1.
15950803|NCT03257995|Drug|Indacaterol maleate|150 μg via Concept1 device
15950804|NCT03257995|Drug|Indacaterol acetate|150 μg via Concept1 device
15950805|NCT03257995|Drug|Placebo|Capsule containing no active ingredients delivered via Concept1 device
15950806|NCT03257982|Procedure|BCI-FES hand therapy|BCI-FES rehabilitation therapy of the upper limb
15950809|NCT03257956|Device|Investigational Group|The RHEA device and Philips Patient Monitor MX400 are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.
15950810|NCT03257956|Device|reference group|The reference device Earlysense 2.0 system(vital sign monitoring system) and Philips Patient Monitor MX400 are used to monitor the heart rate (HR) and respiratory rate (RR) of participants.
15950811|NCT03257943|Drug|Ivermectin Lotion, 0.5%|Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.)
15950812|NCT03257943|Drug|SKLICE (ivermectin) Lotion, 0.5%|SKLICE (ivermectin) Lotion, 0.5% (Arbor Pharmaceuticals, LLC)
15950813|NCT03257943|Drug|Vehicle of the Test product|Vehicle for Ivermectin Lotion, 0.5% (Taro Pharmaceuticals Inc.)
15950814|NCT03257930|Drug|ethanol injection|inject ethanol in cystic thyroid nodule and follow up until complete recovery
15950815|NCT03257917|Other|Understanding value in Metastatic Breast Cancer|The overall objective of this project is to gain knowledge about out-of-pocket (OOP) expenses and lost opportunity costs among metastatic breast cancer (MBC) patients. To achieve this objective, MBC patients will be asked to participate in a short, 37-question survey asking questions about the financial burden, OOP expenses, and opportunity costs related to their cancer care.
15950816|NCT03257904|Procedure|intracranial pressure monitoring|measurement of intracranial pressure
15950817|NCT03257891|Drug|Cabazitaxel|Cabazitaxel will be administered every 21 days
15950818|NCT03257878|Other|validated Korean version of the SF36 and EQ-5D|"This is an observational prospective study. SF36 consists of 36 questions that measure patient's HRQoL in 8 domains: physical functioning (PF), role-physical (RP), bodily pain (BP), general health (GH) that represent the physical HRQoL, vitality (VT), social functioning (SF), role-emotional (RE), and mental health (MH) that represent the mental HRQoL. Each domain is scored from 0 (worst health status) to 100 (best health status). The scores of these domains are summarized into the physical component score (PCS) and mental component score (MCS).
~The EQ-5D questionnaire is made up for 2 components; health state description and evaluation. In description part, health status is measured in terms of 5 dimensions (5D); mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. In evaluation part, the respondents evaluate their overall health status using the visual analogue scale (EQ-VAS)."
15950819|NCT03257865|Drug|Brexpiprazole|Brexpiprazole was administered orally with flexible dosing from 2 to 4 mg/day; titrated to a maximum of 4 mg/day for 3 weeks.
15950820|NCT03257865|Drug|Placebo|Administered orally daily for 3 weeks.
15950821|NCT03257852|Drug|ASP5094|intravenously administration
15950822|NCT03257852|Drug|Placebo|intravenously administration
15950825|NCT03257839|Device|Routine Digital Breast Tomosynthesis|Routine screening tomosynthesis exam, CC + MLO views.
15984664|NCT03003247|Drug|IDP-120 Gel|IDP-120 Gel is a combination product
15950827|NCT03257826|Device|kirschner wire|retrograde percutaneous kirschner wire was applied to stabilize the tibia.
15950828|NCT03257813|Drug|PRO-122|1 drop every 12 hours for 30 days of alternating treatment with 30 days
15950829|NCT03257813|Drug|Krytantek Ofteno®|1 drop every 12 hours for 30 days of alternating treatment with 30 days
15950830|NCT03257800|Drug|Ketamine|Ketamine 0,5mg.kg-¹was injected intravenously one minute prior propofol 3mg.kg-¹ and one minute before LMA insertion in Ketamine-propofol group
15950831|NCT03257800|Drug|placebo|The control group which received intravenously the same volume with normal saline one minute prior propofol 3mg.kg-¹ and 1 min before LMA insertion in propofol group
15950832|NCT03257787|Other|new adhesive strip|This is a strip made of a newly developed adhesive
15950833|NCT03257774|Other|Adhesive strip A|Strip consisting of a newly developed adhesive
15950834|NCT03257774|Other|Adhesive strip B|Strip consisting of a newly developed adhesive
15950835|NCT03257774|Other|Adhesive strip C|Strip consisting of a newly developed adhesive
15950836|NCT03257761|Biological|Durvalumab|Given IV
15950837|NCT03257761|Drug|Guadecitabine|Given SC
15950838|NCT03257748|Radiation|Laser Therapy|The groups will be submitted to 12 sessions of phototherapy held twice a week for six weeks, during which only the researcher in charge of programming the phototherapy device will be aware of which treatment is being employed. However, the programmer will not participate in the execution of the treatments, evaluations or data analysis.
15950839|NCT03257748|Radiation|LED therapy|The groups will be submitted to 12 sessions of phototherapy held twice a week for six weeks, during which only the researcher in charge of programming the phototherapy device will be aware of which treatment is being employed. However, the programmer will not participate in the execution of the treatments, evaluations or data analysis.
15950840|NCT03257735|Diagnostic Test|next-generation sequencing|"Patients' cerebrospinal fluid, blood and tumor tissue were collected within 3 days before treatment at diagnosis.
~Patients' cerebrospinal fluid and blood were extracted at the time of first evaluation of efficacy after treatment (TKI began after 1 month or chemotherapy after 2 cycles).
~Patients' cerebrospinal fluid and blood were extracted at first time of tumor progression，and re-biopsy of tumor tissue was done as much as possible.
~All the samples were tested by next-generation sequencing."
15950841|NCT03257722|Drug|Pembrolizumab|Anti PD-1 immunotherapeutic agent, which blocks a protective mechanism on cancer cells to allow the immune system to destroy cancer cells. Administered intravenously (IV).
15950842|NCT03257722|Drug|Idelalisib|Phosphatidylinositol 3-kinase (PI3K) inhibitor which promotes anti-tumor immune response. Administered orally (PO).
15950843|NCT03257709|Procedure|Arthroscopic acetabular labral repair|Acetabular labral tear will be identified and reattached using suture anchors until a stable repair is achieved. If evidence of FAI is present ie: a cam or pincer lesion is identified then this will be treated with osteochondroplasty (cam) or acetabular rim recession (pincer).
15950844|NCT03257709|Procedure|Arthroscopic acetabular labral resection|The acetabular labral tear will be identified and its' limits defined. The torn portion of labrum will be resected to a stable edge. As with arm 1 there will be treatment of FAI if identified.
15950845|NCT03257696|Diagnostic Test|Close-ended questionnaire|"Yes/no questionnaire used in order to identify reliable respondent and unreliable respondent"
15950846|NCT03257683|Drug|Ranolazine|Study group will receive additional therapeutic dosing of drug.
15950847|NCT03257670|Drug|4% Topical Lidocaine Gel|This group will be given 4% topical lidocaine gel to take home. The patient will apply the 4% lidocaine gel to the outside and opening of the vagina for 3 minutes before vaginal penetration. The patient will continue using the numbing gel prior to vaginal penetration for the extent of the study (3 months).
15950848|NCT03257670|Device|CO2RE fractional laser therapy|This group will undergo vaginal CO2 laser therapy for a total of three (3) treatments with one month between treatments.
15950849|NCT03257657|Behavioral|Observation Group participants|Women in the observation group will receive usual WIC care, plus the opportunity to meet with a WIC Registered Dietitian (RD) at the 12 week visit. Written WIC materials on lifestyle recommendations will also be given to all observation group participants at the baseline visit. The Investigators will connect with the participant prior to the 12 week visit to make an appointment to meet with the WIC RD at that time.
15950850|NCT03257657|Behavioral|Lifestyle group participants|Women in this group will receive typical WIC care plus the below described activities. The intervention will last 12 weeks.
15950851|NCT03257644|Drug|Ruxolitinib phosphate cream|Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment.
15950852|NCT03257631|Drug|Pomalidomide|: Subjects will be administered pomalidomide on Days 1 to 21, followed by a 7-day rest period, of each 28-day treatment cycle and will continue treatment for up to 24 cycles or until disease progression, withdrawal of consent/assent or unresolved toxicities as described in the protocol.
15950853|NCT03257631|Drug|Pomalidomide|Pomalidomide will be provided as gelatin capsules and as an oral suspension. The starting dose will be 2.6 mg/m²/day, administered on Days 1 to 21, followed by a 7-day rest period, of each 28-day treatment cycle.
15950854|NCT03257618|Drug|Temozolomide|"Treatment with TMZ will be given orally according to standard practices. The therapeutic schedule will be left at the investigator's discretion.
~Patients will be followed every 3 months during the treatment period, at the end of the treatment with TMZ, 6 months after the end of TMZ, and then annually until tumor progression."
15950855|NCT03257618|Other|QoL, neurocognitive and psycholpathological assessment|This assessment will be performed at baseline, at 6 months, 12 months, 18 months, at the end of the treatment with TMZ, 6 months after the end of TMZ
15950856|NCT03257592|Drug|[11C]DPA-713|[11C]DPA-713 PET imaging
15950857|NCT03257579|Other|90 Day Supply|Policy Change implementing a 90 day standardized discharge prescription form with 3 repeats for all cardiac medications available on all wards where MI patients are managed at Hamilton Health Sciences sites
15950858|NCT03257579|Behavioral|Education|Education Alone provided at St. Joseph's Hospital and Niagara Health System
15950859|NCT03257553|Diagnostic Test|fecal calprotectin , doppler and ultrasound|faecal sample for measurement of calprotectin level ultrasound and doppler
15950860|NCT03257540|Device|Small Bone Intramedullary Nail|Patients undergoing a Lapidus Arthrodesis procedure for hallux valgus correction who are receiving a Phantom Small Bone Intramedullary nail will begin weight-bearing at 2 weeks and follow a pre-determined post-operative protocol.
15950861|NCT03257527|Behavioral|ENHANCE group|The ENHANCE program includes an initial 3-month treatment of 12 weekly sessions (including an introductory session, a final session, and 10 content sessions) followed by a 3-month maintenance phase intervention with bi-weekly sessions. Over the course of the program, participants will learn about 10 evidenced-based principles of happiness and how these principles can be applied effectively in their lives. At the final session, participants will receive feedback outlining the happiness principles and activities that fit them best, and will then be asked to work on creating a plan for integrating those principles into their daily lives.
15950862|NCT03257527|Behavioral|MBSR group|"The MBSR program is based on the self-help workbook entitled, A Mindfulness-Based Stress Reduction Workbook. This workbook is authored by Drs. Bob Stahl and Elisha Goldstein - who are both certified MBSR trainers. The workbook is written to help everyday people learn how to replace stress-promoting habits with mindfully-based ones to improve overall well-being. The workbook begins by providing a thorough introduction to the basic tenets of mindfulness, and improving well-being through the use of mindfulness-based skills. The workbook outlines, in detail, several skills-based exercises for practicing mindfulness across different aspects of a person's life. The MBSR group will be provided with a recommended weekly schedule for the initial 3-month treatment and a list of additional resources to be completed over the 3-month maintenance phase."
15950863|NCT03257514|Drug|alpha lipoic acid drug (thioctic acid acid)|Alpha lipoic acid has anti-inflammatory, antioxidant effects and plays a role in wound healing process.
15950864|NCT03257514|Drug|Placebo Oral Tablet|placebo oral drug have the same shape of thiotacid tablet
15950865|NCT03257501|Device|FreeStyle Libre Flash Glucose Monitoring System|Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System and will receive no treatment except for safety purposes.
15950866|NCT03257488|Device|type IV portable monitoring (Somnocheck micro Weinmann)|Somnocheck micro Weinmann: a screening device for sleep disorders assessment. Somnocheck 2 Weinmann: a diagnostic device for obstructive sleep apnea.
15950867|NCT03257475|Radiation|Brachytherapy|Intracavitary irradiation starts at the end of the external beam radiation using image-guided CT/SIM.CT/SIM (transverse axis) is done to complete 3/2D treatment planning. Measurement VRL, PIBS and PIBS ± 2cm, R-V were recorded; Brachytherapy plan: Point A: 24-30Gy/4-5f, or 21-28Gy/3-4f HR-CTV: ≥85Gy, IR-CTV 65Gy dose records
15950868|NCT03257462|Drug|SPR001|SPR001 Capsules
15950869|NCT03257449|Dietary Supplement|Viscous Fibre|Meta-analysis of Randomized Controlled Trials
15950870|NCT03257436|Device|CRT-D|Left Ventricular MultiSite Pacing
15950871|NCT03257423|Drug|Ertapenem followed by levofloxacin and metronidazole|Ertapenem 1 g i.v. daily for either 2 days (MAPPAC + APPAC II patients) or 3 days (MAPPAC + APPAC III) followed by p.o. levofloxacin 500 mg x 1 + metronidazole 500 mg x 3 for either 5 days (APPAC II + MAPPAC) or 4 days (APPAC III + MAPPAC)
15950872|NCT03257423|Drug|Moxifloxacin|Moxifloxacin 400 mg once a day for seven days (APPAC II + MAPPAC)
15950873|NCT03257423|Procedure|Appendectomy|Primarily laparoscopic appendectomy for either complicated acute appendicitis or uncomplicated acute appendicitis (refusing to participate in APPAC II or III trials or recurrent acute appendicitis).
15950874|NCT03257423|Other|Placebo|Placebo i.v. once a day for three days (APPAC III + MAPPAC) followed by placebo capsules three times a day for four days.
15950875|NCT03257410|Device|Theranova 400 dialyzer|Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
15950876|NCT03257410|Device|Elisio-17H dialyzer|Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study.
15950877|NCT03257397|Device|theta-burst stimulation (TBS) using a MagPro X1000|iTBS over left and cTBS over right dorsolateral prefrontal cortex for a period of three weeks. iTBS: 3-pulse 50 Hz bursts will be given every 200ms (at 5 Hz) in 2-second trains with an inter-train interval of 8 seconds. cTBS: 3-pulse 50 Hz bursts will be given every 200ms (at 5 Hz) in a single 40s train; one session will comprise left iTBS and right cTBS. There will be two sessions daily with 60 min in between sessions
15950878|NCT03257397|Device|theta-burst stimulation (TBS) using a MagPro X1000|iTBS over left and right dorsolateral prefrontal cortex for a period of three weeks. iTBS consists of 3-pulse 50 Hz bursts which will be given every 200ms (at 5 Hz) in 2-second trains with an inter-train interval of 8 seconds. One session will comprise left and right iTBS. There will be two sessions daily with 60 min in between sessions
15950879|NCT03257384|Other|Black box recording of surgery|Time delays will be recorded from the moment the patient is draped and enters the operating room to the moment they exit the operating room.
15950880|NCT03257358|Drug|Fingolimod|Commercially available 0.5mg hard capsules, taken orally once per day
15950881|NCT03257332|Procedure|Low Anterior Resection for Rectum Cancer|Subjects should have received curative surgery for rectal cancer (low anterior resection) with/with-out adjuvant (radiation/chemo) therapy.
15950882|NCT03257319|Drug|inhaled titration of morphine chlorhydrate|Patient in arm A will receive 1 to 3 titration
15950883|NCT03257319|Drug|IV placebo|Patient in arm A will receive 1 to 6 injection
15950884|NCT03257319|Device|Inhaled placebo|Patient in arm B will receive 1 to 3 titration
15950885|NCT03257319|Drug|IV titration of morphine chlorhydrate|Patient in arm BA will receive 1 to 6 injection
15950886|NCT03257306|Procedure|ureteral double-J stent removal using magnet|Double-J ureteric stent removed using magnet
15950887|NCT03257306|Procedure|ureteral double-J stent removal using cystoscopy|Double-J ureteric stent removed using cystoscopy
15950888|NCT03257293|Behavioral|Modified Cystoscopy|The objective of this study is to examine whether a non-pharmacologic modification in procedure of cystoscopies improves patient perception of pain and discomfort.
15950889|NCT03257293|Behavioral|Routine Cystoscopy|Routine cystoscopy as done as part of routine clinical practice
15950890|NCT03257280|Other|Early oral nutrition|An early oral nutrition with supplements and increased progressively according to an established schedule, start 48 hours after total gastrectomy.
15950891|NCT03257267|Drug|Cemiplimab|Intravenous (IV) administration every 3 weeks (Q3W)
15951034|NCT03256162|Drug|Midazolam|A sub-anaesthetic dose of midazolam will be administered in four infusions, each one week apart.
15951035|NCT03256149|Drug|Dexamethasone|
15951036|NCT03256149|Drug|Placebo|Normal saline (IV placebo)
15950892|NCT03257267|Drug|Investigator Choice (IC) Chemotherapy|"IC chemotherapy options include:
~Antifolate: Pemetrexed
~Topoisomerase 1 inhibitor: Topotecan or Irinotecan
~Nucleoside analogue: Gemcitabine
~Vinca alkaloid: Vinorelbine
~The only chemotherapy treatments allowed in the control arm are any of the 5 drugs that are listed as IC options above."
15950893|NCT03257254|Drug|Varithena|Administration procedures and volume are per standard of care, full prescribing information, and instructions for use.
15950894|NCT03257241|Drug|A arm (DA-90)|After confirming the diagnosis, assuming the inclusion criteria and exclusion criteria are respected, the patients are randomized to one of two standard induction treatment protocols (A arm: DA-90 vs B arm: DAC). After completing induction I, an early bone marrow assessment is performed on day 14 from the beginning of the treatment (+ day 7 after finishing chemotherapy) using the cytological method and MRD is assessed by the immunophenotyping method. Therapeutic decision is taken on the basis of the cytological assessment. Patients, in whom the percentage of blasts in the bone marrow on day 14 is > 10%, receive early induction II from day 16. An Immunophenotype test is a complementary examination.
15950895|NCT03257241|Drug|B arm (DAC)|After confirming the diagnosis, assuming the inclusion criteria and exclusion criteria are respected, the patients are randomized to one of two standard induction treatment protocols (A arm: DA-90 vs B arm: DAC). After completing induction I, an early bone marrow assessment is performed on day 14 from the beginning of the treatment (+ day 7 after finishing chemotherapy) using the cytological method and MRD is assessed by the immunophenotyping method. Therapeutic decision is taken on the basis of the cytological assessment. Patients, in whom the percentage of blasts in the bone marrow on day 14 is > 10%, receive early induction II from day 16. An Immunophenotype test is a complementary examination.
15950896|NCT03257241|Drug|A arm (CLAG-M)|"Patients who do not achieve CR after two courses of induction therapy or patients with relapsed leukemia are eligible for emergency treatment (salvage) according to the CLAG- M or FLAG-IDA protocol."
15950897|NCT03257241|Drug|B arm (FLAG-IDA)|"Patients who do not achieve CR after two courses of induction therapy or patients with relapsed leukemia are eligible for emergency treatment (salvage) according to the CLAG- M or FLAG-IDA protocol."
15950898|NCT03257228|Genetic|comparative semiquantitative immunohistochemistry|
15950899|NCT03257215|Drug|Stoss vitamin D|A single 1.5 mL dose containing 150,000 IU cholecalciferol (100,000 IU/mL) administered on Day 1 (Solution in Olive Oil B.P. )
15950900|NCT03257215|Drug|Daily vitamin D|Daily 0.2 mL dose containing 1000 IU cholecalciferol administered from Day 1 to 90
15950901|NCT03257215|Drug|Stoss placebo|A single 1.5 mL dose administered on Day 1
15950902|NCT03257215|Drug|Daily placebo|A once daily 0.2 mL dose administered from Day 1 to 90
15950903|NCT03257202|Drug|Clindamycin 1% Gel|topical clindamycin
15950904|NCT03257202|Drug|Benzoyl peroxide 5% gel|topical benzoyl peroxide
15950905|NCT03257202|Drug|BenzaClin 5%-1% Topical Gel|Topical clindamycin and benzoyl peroxide together
15950906|NCT03257189|Device|Physiological signal monitor|Wireless remote monitoring system intended for use by researchers and healthcare professionals for continuous collection of physiological data in home and healthcare settings.
15950907|NCT03257189|Device|Heart rate and heart rate variability comparison device|FDA cleared reference device that monitors heart rate and heart rate variability in subjects
15950908|NCT03257189|Device|Respiration rate comparison device|FDA cleared reference device that monitors respiration rate in subjects
15950909|NCT03257189|Other|Activity classification|Visual annotation of subject posture and other activities used for reference
15950910|NCT03257176|Behavioral|Stepping Stones and Creating Futures|21 session intervention, comprising of 10 Stepping Stones sessions focused on gender, relationships and communication. 11 Creating Futures sessions focused on livelihoods.
15950911|NCT03257163|Drug|Capecitabine|Given PO
15950912|NCT03257163|Other|Laboratory Biomarker Analysis|Correlative studies
15950913|NCT03257163|Biological|Pembrolizumab|Given IV
15950914|NCT03257163|Radiation|Radiation Therapy|Undergo radiation therapy
15950915|NCT03257150|Procedure|Irreversible Electroporation|Irreversible electroporation (IRE) is a process that uses the NanoKnife system to sent electrical currents to a cancer tumor which will disrupt the tumor cell and therefore causing the cell to die. Eligible patients will undergo in situ IRE performed via laparotomy surgery.
15950916|NCT03257150|Device|NanoKnife System|A system consisting of electrode probes connected to a machine. The probes will be surgically placed around the tumor.
15950917|NCT03257137|Other|Diet Quality|Diets matched for calorie intake and macronutrient distribution but differing by overall diet quality will be provided in a random order, cross-over design study.
15950918|NCT03257124|Drug|AZD9291|AZD9291 160mg per oral daily (1 cycle of 28 days)
15950919|NCT03257111|Other|activity monitors|activity monitors are worn on the wrist, much like a watch. Data from the activity monitors will be downloaded once a week and at discharge. Normal hospital and therapy activities will not be altered.
15950920|NCT03257098|Biological|allo-APZ2-CVU|Suspension of ABCB5-positive mesenchymal stem cells
15950921|NCT03257085|Other|Low-carbohydrate, high-fat|Participants following low-carbohydrate, high-fat diet for 8 weeks.
15950922|NCT03257085|Other|High-carbohydrate, moderate-fat|Participants following high-carbohydrate, moderate-fat diet (UK dietary guidelines) for 8 weeks.
15950923|NCT03257072|Biological|50 Necator americanus L3 larvae|1x50 Necator americanus L3 larvae
15950924|NCT03257072|Biological|100 Necator americanus L3 larvae|2x50 Necator americanus L3 larvae
15950925|NCT03257072|Biological|150 Necator americanus L3 larvae|3x50 Necator americanus L3 larvae
15950926|NCT03257059|Other|Breakfast|Glutinous rice (75 grams of available carbohydrate)
15950927|NCT03257059|Other|No Breakfast|No food to be served in the morning
15950928|NCT03257046|Drug|ITI-214|Oral
15950929|NCT03257046|Other|Placebo|Oral
15950930|NCT03257033|Drug|Gemcitabine|Chemotherapy
15950931|NCT03257033|Drug|nab-paclitaxel|Chemotherapy
15950932|NCT03257033|Device|RenovoCath|Intra-arterial catheter
15951037|NCT03256136|Drug|Carboplatin|Chemotherapy
15951038|NCT03256136|Drug|Nivolumab|will allow the body's immune system to work against tumor cells
15951039|NCT03256136|Drug|pemetrexed|Chemo therapy
15951040|NCT03256136|Drug|Ipilimumab|will allow the body's immune system to work against tumor cells
15950933|NCT03257020|Diagnostic Test|SD-OCT|SD-OCT was performed to all subjects to measure BMO-MRW and RNFL thickness by trained glaucoma specialist. It takes about 5 to 10 minutes. The foveal location was manually detected with a live B-scan, followed by defining BMO center. A radial pattern containing 24 angular, equidistant, high-resolution 15° B-scans centered on the BMO was used to compute the neuroretinal rim parameters. The BMO points and ILM were identified and marked in each B-scan with automated software (Glaucoma Module Premium Edition, version 6.0; Heidelberg Engineering). After radial scan completed, 3 consecutive circumpapillary B-scans were followed to measure RNFL thickness at diameter of 3.5, 4.1 and 4.7mm. BMO-MRW and RNFL thickness was automatically computed globally and sectorally.
15950934|NCT03257007|Behavioral|Mindfulness|The Mindfulness intervention sessions are designed to cultivate present-moment awareness in everyday life to facilitate adaptive and non-reactive relating to thoughts, feelings, and bodily sensations. Participants will be provided with 10-20 minute audio recordings of each of 5 mindfulness practices covered in class, recorded in the facilitator's voice. Participants will be encouraged to practice mindfulness at home 10-20 minutes per day, 6 days per week. Participants will be provided with weekly diaries on which to record type and amount of home practice of mindfulness skills.
15950935|NCT03256994|Device|Yttrium-90 loaded SIR-Spheres microspheres|Selective internal radiation therapy (SIRT), also called radioembolisation (RE), with SIR-Spheres microspheres is an endovascular procedure, included within the interventional oncologic technologies to treat primary and secondary liver tumours. Using a microcatheter, a precise dose of resin microspheres is released in the hepatic artery, where they are carried into the arterioles and selectively lodge in the tumour microvasculature. The microspheres are loaded with the radioactive yttrium-90, a high-energy beta-emitting isotope with a half-life of 64.1 hours. SIR-Spheres microspheres are manufactured by Sirtex Medical.
15950936|NCT03256994|Behavioral|QLQ-C30 with HCC module|In order to measure the palliative aspect of RE with SIR-Spheres microspheres, CIRT-FR will incorporate a quality-of-life questionnaire. CIRT-FR will be using EORTC's QLQ-C30 with HCC Module to measure changes in the quality of life of the patient. The quality-of-life questionnaire will be offered to the patient before the treatment, shortly after the treatment (as soon as possible) and at every follow-up. Filling out the quality-of-life questionnaire is entirely voluntary for the patient
15950937|NCT03256981|Radiation|SBRT|SBRT dose and fractionation dependent on site of metastasis and proximity to critical normal tissues.
15950938|NCT03256981|Drug|TKI|Continued background TKI alone
15950939|NCT03256968|Drug|Ataluren|ataluren
15950940|NCT03256955|Device|Tof cuff|The Tof Cuff will be installed on one arm. After anesthesia induction the Tof Cuff will be calibrated and continuos monitoring of the neuromuscular block started until complete recovery of neuromuscular block.
15950941|NCT03256955|Device|Tof Watch SX|The Tof Watch SX will be installed on the opposite arm to the Tof Cuff. After anesthesia induction the Tof Watch SX will be calibrated and continuos monitoring of the neuromuscular block started until complete recovery of neuromuscular block.
15950942|NCT03256942|Device|Etermis 4®|Etermis 4® is a sterile non-pyrogenic physiological gel made of reticulated hyaluronic acid (HA) of non-animal origin.
15950943|NCT03256929|Behavioral|Personalized Diet-driven microbiota|Based on the results of the individual microbiota profile, the investigators will formulate a specific diet aiming to enrich the distinct microbiota with organisms correlated to better mental health. The dietitian will visit each participant twice a month.
15950944|NCT03256929|Behavioral|General information on nutrition and health|General information on nutrition and health. The dietitian will visit each participant twice a month.
15950945|NCT03256916|Drug|Nelfinavir|Nelfinavir (HIV protease inhibitor) targets proteasome and inhibits AKT phosphorylation and plays an important role in radiosensitization of tumour cells.Nelfinavir will be given to the patient orally with food, because the bioavailability increases under the influence of food.
15950946|NCT03256916|Drug|Cisplatin|Cisplatin will be administered on a weekly basis with a dose of 40 mg/m2 by IV infusion over a period of 1 hour 2-4 hours prior to start of EBRT. Patient will be premedicated with I.V Ondansetron to prevent emesis. Pre chemotherapy and post chemotherapy, patient will be administered IV fluids for effective renal clearance of cisplatin.
15950947|NCT03256916|Radiation|Pelvic EBRT and Brachytherapy|Pelvic EBRT will delivered by standard 4 field technique using 6MV/15 MV photon beams. Prior to delivery of radiation, patients will be simulated by CT simulator for planning the beam arrangements. Total dose of pelvic EBRT will be 46Gy/23 #/4.5 weeks. The prescribed dose will be specified according to ICRU 50 guidelines. All patients will be treated with 3D conformal external radiation with target delineation and multileaf collimator leaf shaping.
15950948|NCT03256903|Drug|Methoxyflurane|Up to two inhalers containing 3 mL methoxyflurane. Treatment duration: 1 administration in 1 day.
15950949|NCT03256903|Drug|Standard of care|Any kind of analgesia, administered by any route for emergency relief of moderate to severe pain in conscious adult patients with trauma and associated pain
15950950|NCT03256890|Behavioral|MB-BP Intervention|MB-BP customizes Mindfulness-Based Stress Reduction (MBSR) to participants with hypertension. It consists of nine 2.5-hour weekly group sessions and a 7.5-hour one-day session. Content includes education on hypertension risk factors, hypertension health effects, and specific mindfulness modules focused on awareness of BP determinants such as diet, physical activity, anti-hypertensive medication adherence, alcohol consumption, and stress reactivity. Students learn a range of mindfulness skills including body scan exercises, meditation and yoga. Homework consists of practicing skills for ≥45 min/day, 6 days/week. Participants are given a home BP monitor. Participants with uncontrolled hypertension are offered to have their physicians notified, if not already overseen for uncontrolled hypertension; those without a physician are worked with to provide access within health insurance constraints.
15950951|NCT03256890|Other|Enhanced Usual Care Control|"Control group participants receive an educational brochure from American Heart Association entitled Understanding and Controlling Your High Blood Pressure Brochure (product code 50-1639). Every participant is provided with a validated home blood pressure monitor (Omron, Model PB786N), that as an evidence-based approach to lower blood pressure, would be considered enhanced usual care at this time. All participants who have uncontrolled hypertension (blood pressure >140/90 mmHg) will be offered to have their physicians notified, if not already being overseen for uncontrolled hypertension. For participants with uncontrolled hypertension who do not have a physician, we work participants to provide access within constraints of their health insurance."
15951326|NCT03253978|Radiation|Stereotatic Radiotherapy|SABR to prostate / seminal nodes
15950952|NCT03256864|Drug|Tacrolimus and Everolimus|"In the TAC and EVR BID arm, everolimus will be initiated at a dose of 1.0 mg BID within 24 h of randomization with the dose adjusted from day 5 onward to maintain trough (C0) concentration in the range 3-8 ng/mL. Tacrolimus will be initiated at a dose of 0.15 mg/kg BID and then taper to 0.10 mg/kg BID to maintain trough (C0) concentration in the range 2.5-5 ng/mL.
~In the TAC and EVR QD arm, everolimus will be initiated at a dose of 2.0 mg QD within 24 h of randomization with the dose adjusted from day 5 onward to maintain trough (C0) concentration in the range 3-8 ng/mL. Tacrolimus will be initiated at a dose of 0.1-0.2 mg/kg/day QD to maintain trough (C0) concentration in the range 2.5-5 ng/mL."
15950953|NCT03256851|Behavioral|Telephone-Delivered Exercise Therapy|"A combination of aerobic and resistance training has been shown to be most effective for reducing fatigue in persons with MS.
~Aerobic training will consist of: 30 minutes of either cycling, treadmill walking or overground walking, 2x/week. Participants will be given a wrist-worn pedometer with heart-rate monitor to track their heart rate during training. Participants will be progressed to reach 60-70% of their maximal heart rate during aerobic training over the course of the study.
~Strength training will consist of hip extension, hip flexion, hip abduction, knee extension and knee flexion movements with resistance bands performed 3x/week.
~This home exercise program will be paired with a 1x/week telephone call with an investigator."
15950954|NCT03256851|Behavioral|In-Person Delivered Exercise Therapy|"A combination of aerobic and resistance training has been shown to be most effective for reducing fatigue in persons with MS.
~Aerobic training will consist of: 30 minutes of either cycling, treadmill walking or overground walking, 2x/week. Participants will be given a wrist-worn pedometer with heart-rate monitor to track their heart rate during training. Participants will be progressed to reach 60-70% of their maximal heart rate during aerobic training over the course of the study.
~Strength training will consist of hip extension, hip flexion, hip abduction, knee extension and knee flexion movements with resistance bands performed 3x/week.
~This home exercise program will be paired with a 1x/week visit to the laboratory to work with a physical therapist or trained team member."
15950955|NCT03256838|Drug|Ferric Citrate|Ferric citrate will be provided as a 500mg capsule. All intervention doses will be based on serum phosphorus levels.
15950956|NCT03256825|Diagnostic Test|Rapid diagnostics alone|Urine samples present at the laboratory at opening on weekdays will be screened using urine flow cytometry and microscopy of centrifuged gram stained urine. Samples found positive for significant mono microbial bacteriuria will be investigated further by using direct automated phenotypic identification and antimicrobial susceptibility determination.
15950957|NCT03256825|Other|Real-time antimicrobial stewardship decision support|"A clinical microbiologist will be give RADS by phone to a designated clinician with the aim of:
~Switch to active treatment if non-working empirical treatment
~De-escalate broad spectrum empiric treatment when feasible
~Promote early intravenous to per oral switch
~Shorten treatment duration"
15950958|NCT03256812|Device|ICT-based ECG monitoring|Continuous monitoring will begin from the time of participation in the trial in the ICT-based centralized monitoring group. 24-hr Holter monitoring will be implemented at the 3-, 6-, and 12-month follow-ups in this group, as in the Holter monitoring group. If heart rate drops below 40 beats/min or increases above 120 beats/min on ECG during ICT-based ECG home monitoring, the participant will be notified first through an alarm function.
15950959|NCT03256812|Device|Holter monitoring|24-hr Holter monitoring will be implemented at the 3-, 6-, and 12-month follow-ups
15950960|NCT03256799|Drug|Ivacaftor/Ataluren|Both drugs were given in combination for 48 week study period
15950961|NCT03256786|Behavioral|Prewarming using forced air warmer, warmed intravenous fluid|Combined modality active warming consisting of preoperative 15 min of surface warming using a forced air warmer before spinal anesthesia and coloading of warmed intravenous fluid in active warming group
15950962|NCT03256760|Biological|Endotoxin|Endotoxin
15950963|NCT03256760|Biological|Placebo|Placebo
15950964|NCT03256747|Device|NMES|NMES will be placed at the knee extensors. Stimulation frequency will be 20 Hz. Pulse width will be 0.5 milliseconds and the contraction time will be 10 seconds (TON: 10s) with a 5-second rest interval (TOFF: 5s). Total time application will be 60 minutes. Intensity will be adjusted individually, taking into account the patient's ability to promote the full knee extension and comfort during contractions.
15950965|NCT03256747|Device|NMES-placebo|NMES-placebo will be placed at the knee extensors. Stimulation frequency will be 20 Hz. Pulse width will be 0.5 milliseconds and the contraction time will be 10 seconds (TON: 10s) with a 5-second rest interval (TOFF: 5s). Total time of application will be 60 minutes. Intensity will be adjusted with minimal intensity, utilized to provide a sensory stimulus, but insufficient to elicit a tetanic muscular contraction.
15950966|NCT03256734|Other|Policy intervention|Incentive payment for physicians
15950967|NCT03256721|Drug|Apatinib/docetaxel/pemetrexed|Participants are randomly assigned to treatment group or control group
15950968|NCT03256721|Drug|docetaxel/pemetrexed|Participants are randomly assigned to treatment group or control group
15950969|NCT03256708|Dietary Supplement|Prolardii|Prolardii: 2 capsules per day for 12 to 15 days
15950970|NCT03256708|Dietary Supplement|Placebo|Inactive ingredients
15950971|NCT03256695|Drug|Albuterol sulfate (ABS)|ABS will be administered via eMDPI as per the dose and schedule specified in the arm.
15950972|NCT03256682|Behavioral|Stress management counseling|stress management counseling based on CBT and relaxation
15950973|NCT03256669|Procedure|umbilical incision|exploration through umbilical incision
15950974|NCT03256656|Other|electrical stimulation (non painful) of the lower urinary tract to determine the current perception threshold and record sensory evoked potentials|
15950975|NCT03256643|Behavioral|Exercise|Exercise intervention will consist of 8 exercise classes and exercises at home. A booklet will be given to each person that has a description and photograph of each exercise that designed to work on core strength and balance.
15950976|NCT03256643|Behavioral|Delayed Exercise|People will be tested up to 40 weeks after beginning the intervention.
15950977|NCT03256643|Behavioral|Exercise and enrichment|Exercise and enrichment will consist of the same exercise program described for the exercise intervention. The enrichment protocol consisting of cultural educational program will take place during the exercises and breaks for this group.
15951076|NCT03255876|Dietary Supplement|Enriched pomegranate juice|Pure pomegranate juice enriched with grape seed and apple peel extract (200 ml) to be consumed with 109 g of bread
15984665|NCT03003247|Drug|IDP 120 Component A Gel|Monad of Component A
15950978|NCT03256617|Other|Cognitive reassurance training|The 2-day training program includes 3 sessions that will consist of interactive didactic lectures, solving case studies and role-playing activities. The first session uses lecture and cases to present models of pain and disability, evidence based predictors of disability and delayed recovery and evidence based interventions for patients with low back pain. The second session uses role playing and case studies help the providers to 1) develop skills in identifying maladaptive beliefs about pain in patients with low back pain and 2) develop the skills to address diagnostic uncertainty and negative pain beliefs and 3) develop skills to educate patients with low back pain. The third session will use role playing and case studies to refine the provider' skills in providing cognitive reassurance to patients with low back pain.
15950979|NCT03256604|Diagnostic Test|left-over sputum|Totally 467 samples were gathered from different clinics, and the diagnostic procedures and the therapeutic approaches were completely unknown to the study group. The coded samples were stored at 4-8°C and analyzed within 72 hours of sampling using the sputum strip test. From April to June 2016, a physician and the study nurse reviewed the journals. The age, sex, length of stay on ward, the clinical symptoms, the blood and sputum cultures and PCR along with the results, the X-rays, the antibiotic therapy, CRB-65 and the ultimate diagnosis code (ICD-10) were documented in Excel-files.
15950980|NCT03256591|Other|HBB facilitators with simulation training|HBB training from facilitators with simulation skills. Standard HBB facilitators do not have simulation skills
15950981|NCT03256578|Device|New Life Box Respiratory Function Monitor|The intervention is the use of a visible New Life Box Respiratory Function Monitor display in infants born between 24 and 27 6/7 weeks gestation receiving PPV for resuscitation after birth.
15950982|NCT03256565|Diagnostic Test|Q-tip test|A Q-Tip lubricated with anesthetic gel is inserted into the urethra, woman is then asked to cough and strain, and the angle of the Q-tip rotates is recorded.
15950983|NCT03256552|Drug|Glycopyrronium MDI 28.8 micrograms|Glycopyrronium MDI 28.8 micrograms
15950984|NCT03256552|Drug|Glycopyrronium MDI 14.4 micrograms|Glycopyrronium MDI 14.4 micrograms
15950985|NCT03256552|Drug|Glycopyrronium MDI 7.2 micrograms|Glycopyrronium MDI 7.2 micrograms
15950986|NCT03256552|Drug|Placebo MDI|Placebo Inhalation Aerosol
15950987|NCT03256539|Behavioral|Sleep intervention|Behavioral sleep intervention program
15950988|NCT03256539|Behavioral|Placebo intervention|Quasi-desensitization intervention for insomnia (which does not include any of the active components of CBT-I but implemented in the same frequency and duration)
15950989|NCT03256526|Drug|Placebo|0 mg
15950990|NCT03256526|Drug|PF-06835919 Low Dose|75 mg once daily
15950991|NCT03256526|Drug|PF-06835919 High Dose|300 mg once daily
15950992|NCT03256513|Other|model controlling|control blood pressure by statistical l model with anticipate lowest peri-procedure risk
15950993|NCT03256513|Other|conventional controlling|control blood pressure by conventional strategy
15950994|NCT03256500|Device|Transcranial Direct Current Stimulation|One half of the subjects will receive sham and the other half will receive tDCS. The Soterix Medical 1x1 line of low-intensity tDCS stimulators which we plan to use is designed to generate low levels of direct current current between one anode and one cathode placed on the body. The current enters the body through the positive electrode, the anode exits the body through the negative electrode, the cathode. The accessories provided with the device allow for simple and comfortable positioning of the electrodes on the body.
15950995|NCT03256487|Drug|Buprenorphine|buprenorphine 0.3mg IV
15950996|NCT03256487|Drug|Morphine Sulfate|morphine 0.1 mg/kg IV (max 8mg per dose)
15950997|NCT03256474|Other|Multimodal Therapy|Drugs, external applications like chest wraps, inhalations
15950998|NCT03256461|Behavioral|Lactate clearance 10% target group|Participants receive the protocolized resuscitation to achieve the goal of 10-percent lactate clearance every two hours within the initial six hours of treatment.
15950999|NCT03256461|Behavioral|Lactate clearance 20% target group|Participants receive the protocolized resuscitation to achieve the goal of 20-percent lactate clearance every two hours within the initial six hours of treatment.
15951000|NCT03256461|Behavioral|Standard EGDT group|Participants receive the strategy of early goal-directed treatment of sepsis fluid resuscitation.
15951001|NCT03256435|Behavioral|RAMP PrEP initiation, adherence, and retention intervention|The intervention arm will receive facilitated strengths-based case management (SBCM)-delivered by trained interventionists-to help navigate the PrEP medical care system and support the participant and health care staff in meeting the challenges faced with obtaining PrEP medication (e.g., overcoming insurance barriers or barriers with co-pays). This also includes facilitated integration into the PrEP clinic and obtaining monthly PrEP prescription refills.
15951002|NCT03256422|Drug|Treatment discontinuation|"• Receiving tritherapy. Allowed treatment drugs are :
~nucleoside analogs : tenofovir (TDF ou TAF), emtricitabine, abacavir, lamivudine
~protease inhibitors : lopinavir/r, darunavir/r ou atazanavir/r
~non nucleoside reverse transcriptase inhibitors : efavirenz, rilpivirine ou etravirine
~integrase inhibitors : dolutegravir, elvitegravir/cobicistat ou raltegravir"
15951003|NCT03256409|Other|Adherence mold and yeast and mesophyll aerobe|Adherence mold and yeast and mesophyll aerobe to BOD and BJOD Microbial populations have been controlled in the saliva at initial time and adherence at 30 - 180 days after the overdentures in the mouth. The saliva sample was obtained from the patient in a sterile sputum collection bottle through a sterile solution. The overdenture samples were extracted and processed for analysis. Each sample was submerged in ¼ sterile Ringer and subjected to vigorous ultrasound shaking. From each of the microbial suspensions, successive dilutions were made to determine the total number of viable microorganisms present. Total count of mold and yeast and total count of mesophyll aerobe were performed.
15951004|NCT03256409|Other|Surface Roughness (Ra)|The surface roughness of BOD and BJOD was determined with the rugosimeter the Mitutoyo Surfest SJ-301® (Mitutoyo Corporation Inc., Kanagawa, Japan), through a displacement force of 4mN and of the tray to 0.5 mm/s and back to 1 mm/s (Murtra and Arcís,1999). The roughness profile Ra was evaluated and determined in microns (ųm) through five readings for each of the samples in the study respectively.
15951005|NCT03256396|Procedure|PEEP setting based on esophageal pressure measured|PEEP is set on the basis of esophageal pressure measurement with the aim to maintain transpulmonary pressure during expiration between 0 and 5 cmH2O
15951006|NCT03256383|Device|Lead testing|Fingerstick
15951327|NCT03253965|Other|Metronome Normal|Steps are timed with the beat of the metronome set to the subject's cadence
15951007|NCT03256370|Procedure|milk collection|"Parents of breast-fed infant from general pediatric clinic and allergy clinic of King Chulalongkorn Memorial Hospital were approached for informed about the research and ask to join this project
~After completed informed consent, demographic data was collected and filled in case record form
~Milk of mother in both allergic and control groups were collected 60 ml then transferred to freeze at -80oc to for human milk oligosaccharide analysis
~Method of human milk oligosaccharide analysis :
~Ultra High Pressure Liquid Chromatography(UHPLC) with fluorescence method
~High-Performance Anion-Exchange Chromatography with Pulsed Amperometric Detection (HPAEC-PAD) method"
15951008|NCT03256357|Behavioral|Constraint-induced movement therapy|In a 2-week day camp model children receive constraint- induced movement therapy for six hours a day, for 9 out of 11 consecutive days. All children wear a tailor made hand splint on the unaffected upper limb for 6 hours per day while performing unimanual exercises individually or in a group based on shaping and repetitive practice.
15951009|NCT03256357|Behavioral|Action observation training|Action observation training consists of 15 sessions of 1 hour. Children watch 3 minute video clips of unimanual goal-directed actions followed by 3 minutes of execution of the actions.
15951010|NCT03256357|Behavioral|Placebo observation training|Placebo observation training consists of 15 sessions of 1 hour. Children perform the same actions as the AOT training after watching computer games without biological movements.
15951011|NCT03256344|Biological|Talimogene Laherparepvec|Virally based anti-cancer immunotherapy given by direct injection into tumors.
15951012|NCT03256344|Biological|Atezolizumab|A monoclonal antibody given by intravenous injection.
15951013|NCT03256331|Drug|BEL-X-HG|"This study will be carried out in 2 parts:
~A sequential Dose Escalation Part of four doses following a 3 + 3 design where dose escalation will be made based on DLT, for a single cycle (28 days) of BEL-X-HG treatment
~A Dose Extension Part of up to 5 cycles (28 days each) at the same dose level (starting dose) of BEL-X-HG treatment
~Escalating dose levels of BEL-X-HG in 5 study cohorts and one modified dose will be as follows:
~Cohort 1: Dose level 1 - 0.5 g/day (0.25 g, bid)
~Cohort 2: Dose level 2 - 1.0 g/day (0.5 g, bid)
~Cohort 3: Dose level 3 - 2.0 g/day (1.0 g, bid)
~Cohort 4: Dose level 4 - 4.0 g/day (2.0 g, bid) Modified dose level Cohort 5: Dose level 5 - 1.5 g/day (0.75g bid) This re-escalation is allowed only when dose de-escalates from Dose level 3 to Dose level 2, and 1 DLT in 6 evaluable subjects of Dose level 2."
15951014|NCT03256318|Other|No intervention|No intervention; surveys/questionnaires only
15951015|NCT03256305|Device|"personalized rTMS+drug treatment"|High frequency（10HZ）stimulation of brain regions corresponding to lesion, low-frequency （1HZ）stimulation of the contralateral brain, intensity=90%MT（motor thresholds). Each sequence is 20 times, duration is 10 seconds, each sequence spaced 60s, 20 sequences per day, 1 times a day ,total times is 15. Taking paroxetine 2 weeks, Take 20 mg a day.
15951016|NCT03256305|Device|Traditional rTMS +drug treatment|Traditional rTMS treatment protocol parameters: localization of left DLPFC: frequency=10 Hz; localization of right DLPFC: frequency=1 Hz, intensity=90%MT, Each sequence is 20 times, duration is 10 seconds, each sequence spaced 60s, 20 sequences per day,1 times a day,total times is 15. Taking paroxetine 2 weeks, Take 20 mg a day.
15951017|NCT03256292|Drug|Testosterone replacement|Testosterone replacement therapy
15951018|NCT03256292|Behavioral|lifestyle|lifestyle intervention consisting of diet and increased physical activity
15951019|NCT03256279|Device|".014 NiTi heat-activated archwire"|".014 NiTi heat-activated archwire In the lower arch during the first three months of the orthodonci treatment"
15951020|NCT03256279|Device|".014 NiTi Superelastic archwire"|".014 NiTi superelastic archwireIn the lower arch during the first three months of the orthodonci treatment"
15951021|NCT03256253|Drug|Pregabalin|pregabalin up to 600 mg/day
15951022|NCT03256240|Other|side-to-side functional end anastomosis|type of anastomosis
15951023|NCT03256240|Other|Kono-S analstomosis|antimesenteric anastomosis
15951024|NCT03256227|Behavioral|Family Supported Prolonged Exposure|The investigators propose to bring a family member into early educational sessions of PE, one of the most researched and efficacious treatments for PTSD, to increase family support for PE adherence. Strategies for how to engage with families are drawn from existing evidence-based approaches, including Motivational Interviewing and Behavioral Couples Therapy.
15951025|NCT03256227|Behavioral|Standard Prolonged Exposure|Standard Prolonged Exposure for PTSD as delivered in routine VA care.
15951026|NCT03256214|Procedure|Closed suction system|In mechanically ventilated patients, intratracheal secretions were aspirated with closed suction systems to compare the pulmonary and cardiovascular parameters (Peak Pressure, Resistance, and Pressure Plateau, Heart Rate and Mean, Diastolic, and Systolic Pressures) with open suction system.
15951027|NCT03256214|Procedure|Open suction system|In mechanically ventilated patients, intratracheal secretions were aspirated with open suction systems to compare the pulmonary and cardiovascular parameters (Peak Pressure, Resistance, and Pressure Plateau, Heart Rate and Mean, Diastolic, and Systolic Pressures) with closed suction system.
15951028|NCT03256201|Behavioral|Nutritional Counseling|Patients in both arms receive a single counseling session with a licensed dietician to determine individual protein goal for body weight and current dietary intake. Goal is then met through protein supplementation (provided) if needed beyond dietary intake. For the last 5 days, all participants switch to Impact Advanced Recovery® (provided), as standard care at our facility.
15951029|NCT03256201|Behavioral|Standard Exercise|Patients receive a single instruction session with a physical therapist, for training in moderate intensity (using Rate of Perceived Exertion) exercise including cardiovascular endurance, flexibility, and AROM of upper and lower body. If no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs.
15951030|NCT03256201|Behavioral|Enhanced Exercise|Patients receive a single instruction session with a physical therapist, for training in moderate intensity (using Rate of Perceived Exertion) exercise including cardiovascular endurance, flexibility, and resistance exercise for upper and lower body. If no other preferred mode of endurance training, a home ergometer is provided for use with arms and/or legs.
15951031|NCT03256188|Behavioral|Active classroom|30 minutes of moderate-to-vigorous physical activity
15951032|NCT03256175|Procedure|Percutaneous Coronary Intervention|PCI technique (e.g. pre-dilatation vs. direct stenting and stent choice) was left to operator discretion. Stent post dilatation was permitted as per individual operator practice
15951033|NCT03256162|Drug|Ketamine|A sub-anaesthetic dose of ketamine will be administered in four infusions, each one week apart.
15951041|NCT03256123|Dietary Supplement|red palm shortening group|Biscuits made of red palm shortening will be distributed to the subjects given four days a week on schooling days for a duration of 6 months. The biscuits for each subject will contain ~200 kcal with 10 g of red palm shortening/day (630 µg RE/day). This biscuit would be given four days a week on schooling days for a duration of 6 months. On average in a week, subject is expected to receive 630 µg RE of vitamin A/day. This would fulfill ~70% of the RNI of vitamin A for children aged 7-11 years old.
15951042|NCT03256123|Dietary Supplement|palm shortening group|Biscuits made of palm shortening (control group) will be distributed to the subjects given four days a week on schooling days for a duration of 6 months. The palm shortening biscuits contain corresponding fatty acids as red palm shortening group.
15951043|NCT03256110|Behavioral|Improving Communication about Serious Illness-AI/AN|A one-page summary of patient-specific preferences, barriers and facilitators for engaging in patient-provider communication about advance care planning, provided to patient and provider prior to a clinical encounter with prompts for initiating and/or improving the quality of communication about advance care planning.
15951047|NCT03256084|Procedure|Blood and tumor samples|Blood and tumor samples
15951048|NCT03256071|Drug|Decitabine plus Modified BUCY|"Decitabine:20 mg/m²/day on day -14 to -10;
~Modified BUCY:
~Sibling:semustine 250 mg/m²/day on day -9;cytarabine 2 g/m²/day on day -8；busulfan 3.2mg/kg/day on day -7 to -5;cyclophosphamide 1.8g/m²/day on day -4 to -3.
~Unrelated:semustine 250 mg/m²/day on day -10;cytarabine 2 g/m²/day on day -9 to -8；busulfan 3.2mg/kg/day on day -7 to -5;cyclophosphamide 1.8g/m²/day on day -4 to -3.
~Haploidentical:semustine 250 mg/m²/day on day -10;cytarabine 4 g/m²/day on day -9 to -8；busulfan 3.2mg/kg/day on day -7 to -5;cyclophosphamide 1.8g/m²/day on day -4 to -3."
15951049|NCT03256071|Drug|Modified BUCY|"Sibling:semustine 250 mg/m²/day on day -9;cytarabine 2 g/m²/day on day -8；busulfan 3.2mg/kg/day on day -7 to -5;cyclophosphamide 1.8g/m²/day on day -4 to -3.
~Unrelated:semustine 250 mg/m²/day on day -10;cytarabine 2 g/m²/day on day -9 to -8；busulfan 3.2mg/kg/day on day -7 to -5;cyclophosphamide 1.8g/m²/day on day -4 to -3.
~Haploidentical:semustine 250 mg/m²/day on day -10;cytarabine 4 g/m²/day on day -9 to -8；busulfan 3.2mg/kg/day on day -7 to -5;cyclophosphamide 1.8g/m²/day on day -4 to -3."
15951050|NCT03256058|Procedure|Reinflation after early deflation|the tourniquet would be inflated immediately before incision and deflated after the use of the cement , and 10 minutes later (after the hardening of the cement) , reinflate the tourniquet and deflate at the end of the operation. The total time of tourniquet inflation is controlled within 90 minutes.
15951051|NCT03256058|Procedure|Control|The tourniquet would be inflated immediately before incision and deflated at the end of the operation. The inflation of tourniquet should not last more than 90 minutes.
15951052|NCT03256045|Drug|Carfilzomib|Given IV
15951053|NCT03256045|Other|Chemosensitivity Assay|Undergo in vitro chemosensitivity testing
15951054|NCT03256045|Drug|Dexamethasone|Given PO
15951055|NCT03256045|Other|Laboratory Biomarker Analysis|Correlative studies
15951056|NCT03256045|Drug|Panobinostat|Given PO
15951057|NCT03256019|Procedure|Endotracheal Intubation|Insertion of endotracheal tube into the trachea and supply oxygen using the Ambu-bagging during cardiopulmonary resuscitation
15951058|NCT03256006|Other|Blood sample|Blood sample to study per and post effort evolution markers of systemic inflammation
15951059|NCT03255993|Drug|SPH3127 50mg|SPH3127 50mg
15951060|NCT03255993|Drug|SPH3127 100mg|SPH3127 100mg
15951061|NCT03255993|Drug|Placebo matching to SPH3127 50mg|Placebo matching to SPH3127 50mg
15951062|NCT03255993|Drug|Placebo matching to SPH3127 100mg|Placebo matching to SPH3127 100mg
15951063|NCT03255980|Device|Xonrid® gel|Water based gel for the management of toxicity skin symptoms induced by Radiotherapy
15951064|NCT03255980|Other|Standard of Care|Standard of care suggested by MASCC' Skyn Toxicity Study Group guidelines
15951065|NCT03255967|Behavioral|DSM-H|Multi-modal quality improvement program for improving the quality of care provided to PWD-informal caregiver dyads through HHC
15951066|NCT03255967|Behavioral|Standard of Care|Subjects receive care through usual home healthcare assignment process.
15951067|NCT03255954|Other|Interpersonal Counseling for University Counseling Centers|Interpersonal Counseling (IPC) is a brief version of Interpersonal Psychotherapy (IPT). IPC synthesizes the fundamental IPT principles into 3-6 sessions. Individuals receiving IPC are initially assessed for symptoms of depression, and then encouraged to identify interpersonal problem areas which may be contributing to their presenting symptoms.
15951068|NCT03255941|Drug|DMPA|The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use DMPA.
15951069|NCT03255941|Drug|Sayana Press|The safety and effectiveness of provision of injectable contraception will be compared between providers' screening and counseling for eligibility to use Sayana Press
15951070|NCT03255928|Diagnostic Test|PAS assay, TGT|Evaluation of platelet function
15951071|NCT03255915|Drug|Tenofovir Disoproxil Fumarate (TDF)-Emtricitabine (FTC)|TDF-FTC pod-IVR designed to deliver TDF at a target rate of 1 mg d-1 and FTC at a target rate of 2 mg d-1.
15951072|NCT03255915|Other|Placebo|A placebo pod-IVR containing microcrystalline cellulose pods.
15951073|NCT03255902|Behavioral|Parenting classes|Parenting Classes:The Incredible Years curriculum
15951074|NCT03255889|Drug|Glyceryl Tridecanoate|Glyceryl Tridecanoate (GT) is the triglyceride form of decanoic acid (DA), a C10 fatty acid. GT belongs to the class of medium chain triglycerides (MCT), which has been accepted as a Generally Recognized As Safe food product by FDA. Decanoic acid, also known as capric acid, occurs naturally in coconut oil (8 - 10%) and palm kernel oil (4%).
15951075|NCT03255889|Other|Placebo|Sunflower oil emulsion of equal calories.
15951328|NCT03253965|Other|Metronome Slow|Steps are timed with the beat of the metronome set to 85% of the subject's cadence
15951077|NCT03255876|Dietary Supplement|Placebo beverage|Beverage containing the same type and amount of carbohydrates as pomegranate juice and similar flavor (200 ml) to be consumed with 109 g of bread
15951078|NCT03255863|Other|Questionnaire|Patient Self reported questionnaire filled in.
15951079|NCT03255837|Device|Transcranial direct current stimulation (tDCS)|Transcranial Direct Current Stimulation (tDCS, a form of non-invasive brain stimulation) on the left dorsolateral prefrontal cortex (DLPFC)
15951080|NCT03255824|Drug|Dexmedetomidine and Midazolam|Administration of Dexmedetomidine and Midazolam for sedation during third molar surgery.
15951081|NCT03255824|Drug|Propofol, Midazolam, and Fentanyl|Administration of Propofol, Midazolam, and Fentanyl for sedation during third molar surgery.
15951082|NCT03255811|Drug|apatinib|Apatinib mesylate tablets treatment and to maintain the actual benefit in progression free survival.
15951083|NCT03255798|Device|G2 and G3|Two iStent inject devices and one iStent supra device
15951084|NCT03255785|Device|Cataract surgery plus one iStent and one iStent Supra implanted|Cataract surgery via phacoemulsfication plus one iStent and one iStent supra
15951085|NCT03255772|Diagnostic Test|Magnetocardiography|Study subjects will be placed within a magnetic shielding apparatus. Noninvasive sensors placed over the subject's torso will acquire magnetic field fluctuations generated by cardiac activity, which will then be analyzed for evidence of myocardial ischemia.
15951086|NCT03255759|Diagnostic Test|Multiplex molecular diagnostic assay|To assess the added value and acceptability of a multiplexed molecular diagnostic assay in the identification of pathogens in patients presenting with bacteremia at hospitals in LMICs, and to assess health care providers' satisfaction with the assay.
15951087|NCT03255746|Behavioral|Sleep Enhancement|This regimen combines education and behavioral skills to enable prolonging sleep in chronically sleep deprived subjects so as to better meet participant's sleep needs. This intervention emphasizes plain language communication of cognitive behavioral therapy strategies for initiating and maintaining health behavior change, primarily through using brief action plans (time-limited, personally relevant, behavioral goal setting with confidence), and collaborative problem-solving. Coaching will be provided to modify daily routines and adhere to sleep hygiene practices to allow for extended time in bed.
15951088|NCT03255746|Behavioral|Health Education|This is a placebo/attention control condition. Participants will receive health education based on NIH information. Number, duration, and frequency of sessions will be identical to those administered to the intervention group.
15951089|NCT03255733|Device|Intense Therapeutic Ultrasound Treatment|
15951090|NCT03255707|Device|eye patch|Occluding the better seeing eye for a given number of hours daily
15951091|NCT03255707|Device|dichoptic treatment|dichoptic treatment in the form of playing a video game (Lazy Eye Blocks ®) while wearing a red/green goggle.
15951092|NCT03255694|Drug|PEG-somatropin|After the first stage (52 weeks) of Phase II clinical trial, the initial medication dose of this extension period is 0.2 mg/kg weight/week of PEG-rhGH for high dose group, low dose group and negative control group, and it is adjusted in accordance with yearly height velocity (HV) and IGF-1 SDS of each visit. The maximum dose shall not exceed 0.4 mg/kg weight/week.
15951093|NCT03255681|Procedure|PRP injections into nasojugal folds|"A topical anesthetic consisting of 4% Lidocaine (Topicaine) will be placed in the treatment zone prior to injections for no less than 20 minutes per manufactures recommendations.
~11ml of whole blood will be drawn from the patient via venous aspiration into the Eclipse collection tube. The blood then is centrifuged into three basic components: red blood cells, PRP and platelet-poor plasma. The PRP component is collected via manufactures recommendation, drawn into sterile syringes, and prepared for injection into the patient. 0.1cc of 10% CaCl2 per 1ml of PRP will be added and mixed into the PRP solution for injections on one side of the face.
~Injections will be completed using Softfil micro-cannulas inserted via a small puncture through the patients' skin to dissect into the subcutaneous plane"
15951094|NCT03255655|Device|Intense Therapeutic Ultrasound Treatment - ITU|
15951095|NCT03255642|Drug|Melatonin 2mg|4 weeks of 2mg prolonged release melatonin (Circadin)
15951096|NCT03255642|Drug|ClonazePAM 0.5 MG|4 weeks of 0.5mg clonazepam (Rivotril)
15951097|NCT03255629|Drug|glucagon|novel, stable non-aqueous glucagon formulation provided by Xeris Pharmaceuticals
15951098|NCT03255629|Device|Closed loop glucagon pump|a novel closed-loop glucagon system (CLG) incorporating a novel, stable non-aqueous glucagon formulation together with an infusion pump system (Omnipod) guided by real-time continuous glucose monitoring (Dexcom) that is triggered by a hypoglycemia alert algorithm.
15951099|NCT03255616|Other|mechanical stimulation|mechanical non-painful low- and high pressure stimuli to thoracolumbar segments of healthy subjects and low back pain patients
15951100|NCT03255616|Other|vibrotactile stimulation|non-painful vibrotactile stimulation within a frequency range between 20-150Hz to thoracolumbar segments of healthy subjects and low back pain patients
15951101|NCT03255603|Other|Resistant Starch Type 4 Supplementation|Ten participants will supplement their normal dietary intake with RS4 daily for four consecutive weeks, with each week the amount of RS4 provided being increased (10 g, 20 g, 35 g and 50 g/day).
15951102|NCT03255603|Other|Resistant Starch Type 4 Supplementation|Ten participants will supplement their normal dietary intake with RS4 daily for four consecutive weeks, with each week the amount of RS4 provided being increased (10 g, 20 g, 35 g and 50 g/day).
15951103|NCT03255603|Other|Resistant Starch Type 4 Supplementation|Ten participants will supplement their normal dietary intake with RS4 daily for four consecutive weeks, with each week the amount of RS4 provided being increased (10 g, 20 g, 35 g and 50 g/day).
15951104|NCT03255603|Other|Digestible Starch Supplementation|Ten participants will supplement their normal dietary intake with digestible starch daily for four consecutive weeks, with each week the amount of starch provided being increased.
15951105|NCT03255590|Device|Real tDCS|Anodal Non-invasive brain stimulation to stimulate motor-associated areas in the brain
15951106|NCT03255590|Device|Sham tDCS|Sham Non-invasive brain stimulation to stimulate motor-associated areas in the brain
15951107|NCT03255590|Behavioral|Configuration task|Training the impaired hand on a configuration task
15951108|NCT03255577|Procedure|Sentinel Lymph Node Biopsy (SLNB)|Sentinel Lymph Node Biopsy Patients with locally advanced breast cancer will undergo SLNB with dual tracer mapping followed by completion axillary lymph node dissection.
15951329|NCT03253965|Other|Metronome Fast|Steps are timed with the beat of the metronome set to 115% of the subject's cadence
15951109|NCT03255564|Other|feacal calprotectin concentration|"Intervention - To monitor the impact of cardiac surgery and enteral feeding on gut inflammation, biomarkers (faecal Calprotectin) will be measured 24-48hrs after surgery and 24-48hrs after enteral feed commences. Additionally, infants that are diagnosed with NEC will have calprotectin levels measured.
~Faecal calprotectin - 50-100mg of faeces will be collected in plastic containers from infant's nappies. Samples will then be homogenised by shaking, and supernatants and then sent to laboratories for immediate analysis."
15951110|NCT03255551|Drug|Amosartan|amosartan is a combination of amlodipine, which is a calcium channel blocker (CCB), and rozatan, an angiotensin II receptor antagonist (ARB), and is an antihypertensive agent
15951111|NCT03255538|Other|DFM: Mean pressure|Deep friction massage as described by Dr. James Cyriax, performed with the mean pressure previously obtained in a baseline assessment.
15951112|NCT03255538|Other|DFM: Mean pressure - 25%|Deep friction massage as described by Dr. James Cyriax, performed with the mean pressure previously obtained in a baseline assessment decremented by 25%.
15951113|NCT03255538|Other|DFM: Mean pressure + 25%|Deep friction massage as described by Dr. James Cyriax, performed with the mean pressure previously obtained in a baseline assessment incremented by 25%.
15951114|NCT03255525|Other|Deep friction massage P50|Deep friction massage as described by Dr. James Cyriax, applied with the mean pressure (P50)
15951115|NCT03255525|Other|Deep friction massage P25|Deep friction massage as described by Dr. James Cyriax, applied with the percentile 25 of the mean pressure (P25)
15951116|NCT03255525|Other|Deep friction massage P75|Deep friction massage as described by Dr. James Cyriax, applied with the percentile 75 of the mean pressure (P75)
15951117|NCT03255512|Drug|Vericiguat (BAY1021189) + isosorbite mononitrate|"ISMN up-titration with 30 mg / 60 mg, about 7 days each, prior to start of vericiguat administration
~Starting dose of 2.5 mg taken orally once daily with food, on a background of standard of care. Dose will be up-titrated to 5 mg and to 10 mg:
~2.5 mg vericiguat for about 14 days followed by 5 mg vericiguat for about 14 days followed by 10 mg vericiguat for about 14 days
~60 mg ISMN od on each day of vericiguat administration, taken 1 hour prior to vericiguat (in-house days) or together with vericiguat (out-patient days)"
15951118|NCT03255512|Drug|Placebo + isosorbite mononitrate (ISMN)|"ISMN up-titration with 30 mg / 60 mg, about 7 days each, prior to start of placebo administration
~Placebo for about 14 days, once daily
~60 mg ISMN od on each day of placebo administration, taken 1 hour prior to placebo (in-house days) or together with placebo (out-patient days)"
15951119|NCT03255499|Behavioral|Exercise|Exercise
15951120|NCT03255499|Behavioral|Cognitive|Cognitive
15951121|NCT03255499|Behavioral|Active control|Active control, including a blend of computer games, board games, quizzes, trivia
15951122|NCT03255486|Biological|Blood sample|"Blood samples will be taken by venipuncture during the initial assessment (4 tubes of 5 ml at diagnosis and 3 tubes of 5 ml to the following) These blood tests will be repeated after the first course, at the end of neoadjuvant chemotherapy and after surgery and will be carried out jointly to levies motivated by the balance sheet or the treatment of CS to avoid additional puncture.
~These samples will allow us to study the profiles of circulating tumor DNA, and miRNA tumor proteins (proteomics study)."
15951123|NCT03255473|Drug|Dexamethasone|All subject ID numbers will be randomly assigned to the dexamethasone or the prednisone arm of the trial prior to the initiation of the study.
15951124|NCT03255473|Drug|Prednisone|All subject ID numbers will be randomly assigned to the dexamethasone or the prednisone arm of the trial prior to the initiation of the study.
15951125|NCT03255447|Device|Immunoadsorption|Fresenius Globaffin
15951126|NCT03255434|Drug|Oxaliplatin|Simplified FOLFOX 4 regimen: Association of Oxaliplatin (85 mg/m² ) + simplified LV5FU2 Length of a cycle : 2 days Interval between 2 cycles : 2 weeks (D1=D15) Expected number of cycles: 12
15951127|NCT03255434|Drug|Oxaliplatin LBM|Simplified FOLFOX 4 regimen: Association of Oxaliplatin (LBM) + simplified LV5FU2
15951128|NCT03255421|Other|Pressure measurement|Observational study No intervention, only fragmenting the emptying of the bladder
15951129|NCT03255408|Drug|Drug Lowering Cerebral Blood Flow (CBF) and Normoxia Sleep|The study participants will take Cerebral Blood Flow (CBF) lowering drug and sleep under Normoxia Exposure
15951130|NCT03255408|Drug|Drug Lowering CBF and Intermittent Hypoxia Sleep|The study participants will take Cerebral Blood Flow (CBF) lowering drug and sleep under Intermittent Hypoxia (IH) Exposure
15951131|NCT03255408|Drug|Placebo and Normoxia Sleep|The study participants will take Placebo and sleep under Normoxia Exposure
15951132|NCT03255408|Drug|Placebo and Intermittent Hypoxia Sleep|The study participants will take Placebo and sleep under Intermittent Hypoxia (IH) Exposure
15951133|NCT03255395|Device|Magnetic resonance-guided focused ultrasound|Ten amputees wil recieve a magnetic resonance-guided focused ultrasound treatment aimed at ablating neuromas, which are believe to contribute to their phantom / residual limb pain
15951134|NCT03255382|Drug|Fumaderm|Fumaderm tablet administered orally
15951135|NCT03255382|Drug|risankizumab|Risankizumab administered by subcutaneous (SC) injection
15951136|NCT03255369|Other|Child exposed Zika virus proved|There will be applied Bayley Teste 3rd edition
15951137|NCT03255356|Other|Survey|An anonymised questionnaire will be answered for each includable consecutive patient after verifying the absence of exclusion criteria.
15951138|NCT03255343|Device|IMDENDRIM|In situ and intra tumoral injection of non removal nanodevice IMDENDRIM
15951139|NCT03255330|Drug|Gabapentin|Gabapentin will be given approximately 3 months until no chronic neuropathic pain is present
15951140|NCT03255330|Drug|Metamizol|Standardized treatment
15951141|NCT03255330|Drug|Tramadol|Standardized treatment
15951142|NCT03255317|Behavioral|Reinforcers|Memes/Gifs: Immediately after completing their daily ecological momentary assessment using the app, each participant is randomized to receive an inspirational or funny meme or gif that is displayed within the app. Life Insights: Immediately after completing both daily active tasks using the app, each participant is randomized to unlock a life insight. Life insights track data provided by the participant, are stored in a virtual library within the app, and are regularly updated with recent data points.
15951247|NCT03254550|Other|PrEP Promotion Package|A PrEP promotion package will be developed to test if this will change uptake, acceptance, retention and PrEP knowledge
15951248|NCT03254537|Dietary Supplement|Mediterranean Organic|Traditional Mediterranean diet comprised of organic ingredients
15951143|NCT03255317|Behavioral|Notifications|Reminder Push Notifications: All participants receive a push notification reminder from the app at 6pm (the time at which data collection opens) to complete their daily data collection activities. Each day, each participant will be randomized to receive either a generic reminder or a reminder that contains more detailed information (e.g., about upcoming incentives). Inspirational Push Notifications: Each day, each participant will be randomized to receive a push notification at 4pm that contains inspirational song lyrics or celebrity quotes.
15951144|NCT03255304|Behavioral|health mindest|groups be confronted with health aspects of food items
15951145|NCT03255304|Behavioral|palatability mindset|groups be confronted with palatability aspects of food items
15951146|NCT03255291|Behavioral|Risk Assessment App|The App provides participants with personalized risk results for colon cancer, breast cancer (women), heart disease, diabetes, and stroke.
15951147|NCT03255291|Behavioral|Audio Recording - Sleep|-Participants imagine themselves improving sleep hygiene
15951148|NCT03255291|Other|Surveys|Assesses information comprehension, intentions, perceived risk and severity worry, self- efficacy, response efficacy, affect, race, education, age, numeracy, graph literacy, and exercise and sleep behaviors.
15951149|NCT03255291|Behavioral|Audio Recording - Exercise|Participants imagine themselves improving exercise
15951150|NCT03255291|Other|Text message reminders|-Reminders to practice mental imagery
15951151|NCT03255291|Other|Text Message Survey|-Assesses exercise behavior, intentions, actions plans, self-efficacy, affect, imagery vividness, and practice.
15951152|NCT03255278|Biological|Single GamTBvac vaccination (0.25 dose)|Single administration of the decreased dose of vaccine (0.25 of regular dose) to evaluate the safety.
15951153|NCT03255278|Biological|Placebo administration|Single administration of the placebo (0.5 ml) to a placebo safety study group (Arm 2).
15951154|NCT03255278|Biological|Double GamTBvac vaccination (0.25 dose)|Double sequential administration of the decreased dose of vaccine (0.25 of regular dose) to evaluate the immunogenicity.
15951155|NCT03255278|Biological|Double GamTBvac vaccination (0.5 dose)|Double sequential administration of the mean dose of vaccine (0.5 of regular dose) to evaluate the immunogenicity.
15951156|NCT03255278|Biological|Double GamTBvac vaccination (1.0 dose)|Double sequential administration of the regular dose of vaccine to evaluate the immunogenicity.
15951157|NCT03255265|Other|no interventions|no interventions
15951158|NCT03255252|Drug|Cisplatin injection|Weekly cisplatin (40 mg/m²) will be administered during radiotherapy. At least 3 cycles of cisplatin should be performed according to the hematological and renal functions but not mandatory.
15951159|NCT03255252|Combination Product|radiotherapy|A total dose of 45Gy in 25 fractions to the PTV is considered standard but simultaneous integrated boost or two steps boost to specific volumes (positive lymph nodes for example) are accepted and left to the investigator's discretion).
15951160|NCT03255239|Procedure|Ventral hernia repair|Hernia repair is a surgical procedure to return an organ that protrudes through a weak area of muscle to its original position.
15951161|NCT03255226|Drug|Tolvaptan|Tolvaptan 1% granules or tolvaptan 15 mg tablet with water once daily.
15951162|NCT03255213|Other|Lingual Muscle Training|Lingual Muscle Training using the Iowa Oral Performance Instrument (OIPI) device
15951163|NCT03255200|Device|ReActiv8 Implantable Stimulation System|Implantable electrical stimulation system.
15951164|NCT03255187|Dietary Supplement|Fish oil supplementation|Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in fish oil group are assigned to receive 2.5 g/day in divided doses. Each capsule contains 60% n-3 PUFA [24% docosahexanoic acid (C22:6 n-3 DHA) and 36% eicosapentaenoic acid (C20:5 n-3 EPA)].
15951165|NCT03255187|Dietary Supplement|Sunflower seed oil supplementation|Participants of this randomized double-blind placebo-controlled trial include 70 healthy Chinese adults. The investigators randomly assign participants to two parallel groups at baseline using a random-number table. Compliance is determined by directly observed supplement intake. Participants in sunflower seed oil group receive 2.5 g/day in divided doses, and the capsules are identical as the fish oil capsules.
15951166|NCT03255174|Biological|EVARREST® Fibrin Sealant Patch|EVARREST Fibrin Sealant Patch is a sterile, bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component.
15951167|NCT03255161|Behavioral|community health worker-audiologist communication education and support group|A 5-week educational program on hearing loss, communication strategies, and peer support facilitated by community health workers supervised by an audiologist.
15951168|NCT03255148|Drug|Oxytocin|Syntocinon nasal spray
15951169|NCT03255148|Drug|Placebo|Placebo nasal spray
15951170|NCT03255135|Device|HIFU|High intensity focused ultrasound prostate cancer therapy guided by biopsy specimens and multiparametric prostate magnetic resonance using Focal One, Edap TMS, France device.
15951171|NCT03255122|Behavioral|I-CALM|Families receiving I-CALM will immediately receive a videoconferencing-based, Internet-delivered format of an evidence-based CBT treatment for early child social anxiety disorder (Coaching Approach behavior and Leading by Modeling, or the CALM Program; Puliafico, Comer, & Albano, 2013) in which therapists and families meet in real-time via videoconferencing and parent-child interactions are broadcast from the family's home via a webcam while therapists provide bug-in-the-ear coaching from a remote site. Parents are taught and guided in how to coach their young anxious child to engage in brave, approach behavior.
15951172|NCT03255122|Behavioral|Delayed I-CALM|Families receiving Delayed I-CALM will participate in a waitlist period, and then will complete the I-CALM treatment program.
15951173|NCT03255096|Drug|RO6870810|RO6870810 subcutaneously (SC) at dose of 0.30, 0.45, or 0.65 milligram per kilogram (mg/kg) on Days 1-14 of 21-day cycles.
15951174|NCT03255096|Drug|Venetoclax|Venetoclax tablets orally at dose of 400 mg once daily (QD) continuously for 21 days.
15951175|NCT03255096|Drug|Rituximab|Rituximab intravenously (IV) at dose of 375 mg/m^2 weekly during the first 21-day cycle (C1) and on day 1 of each cycle thereafter.
15951176|NCT03255083|Drug|DS-1205c|DS-1205c 200 mg capsule
15951177|NCT03255083|Drug|Osimertinib|Osimertinib 80 mg tablet
15951178|NCT03255070|Drug|ARX788|An antibody drug conjugate
15951179|NCT03255057|Device|Hemolung Respiratory Assist System|Treatment with a medical device called the Hemolung RAS. The Hemolung RAS includes three components: the Hemolung Controller, the Hemolung Cartridge, and the Hemolung Catheter. The intervention is use of the Hemolung RAS to provide partial lung support for acute hypercapnic lung failure by filtering carbon dioxide from venous blood using a central venous catheter through which venous blood is pumped at flows of 350-550 milliliters per minute to and from an external circuit containing a hollow fiber membrane blood gas exchanger (with heparin-coated fibers) integrated with a centrifugal pump.
15951180|NCT03255057|Device|Invasive mechanical ventilation|Lung support for acute lung failure applied with a mechanical ventilation device that uses positive pressure to mechanically inflate the lungs and facilitate exhalation via an endotracheal tube or tracheotomy.
15951181|NCT03255044|Drug|Atorvastatin|Atorvastatin administered as well as standard heart failure therapy
15951182|NCT03255044|Drug|Rosuvastatin|Rosuvastatin administered as well as standard heart failure therapy
15951183|NCT03255044|Other|guideline directed therapy|standard heart failure therapy
15951184|NCT03255031|Other|Ketogenic Diet (KD) / Standard American (SA) Snacks and Shakes|Ketogenic Diet (KD) / Standard American (SA) Meals and Shakes: Participants will be randomized to a meal plan of either a ketogenic diet (KD) or standard American (SA) diet at the time they sign the consent (day 1 or 2 of admission). For each meal at breakfast, lunch and dinner, the diets will consist of SA meal (carbohydrate rich) or KD meal depending on treatment randomization. Compliance tests are done twice a week with a blood test measuring ketone levels. To ensure that the diet is double blind in both the outpatient and inpatient phases, solid snacks are always ketogenic and shakes are either KD or SA.
15951185|NCT03255018|Biological|Pembrolizumab|Administered intravenously (IV) at a fixed dose of 200 mg every 3 weeks until disease progression or unacceptable toxicity; treatment may continue indefinitely if clinical benefit with options for treatment interruption if responding disease and re-treatment upon relapse.
15951186|NCT03255005|Device|Endomina|Endoscopic sleeve reduction
15951187|NCT03255005|Behavioral|Diet|Multidisciplinary follow-up
15951188|NCT03254992|Device|ASD - Abstract task|Experimental group using Kinect with more virtual activity.
15951189|NCT03254992|Device|ASD - Tangible task|Experimental group using Keyboard with more real activity.
15951190|NCT03254992|Device|TD - Abstract task|Control group using Kinect with more virtual activity.
15951191|NCT03254992|Device|TD - Tangible task|Control group using Keyboard with more real activity.
15951192|NCT03254979|Behavioral|Healthy lifestyle prescription|"3 actions for the prevention of DM2 in the clinical setting are recommended:
~A screening strategy for people with impaired glucose regulation or high risk of developing DM2, with the following recommendations: screening for DM2 within the strategy of opportunistic screening for CV risk factors in population ≥45 years Or ≥30 years in the presence of a previous risk factor (eg, hypertension); Screening for DM2 based on the presence of a BMI ≥25 in the population aged 40-70 years; Or, risk screening for DM2-FINDRISC in a population of 45-70 years.
~With those identified at high risk, perform a structured program of intensive intervention focused on the prescription of personalized plans on lifestyle modification (low calorie and low fat diet, and at least 150 minutes of physical exercise per week).
~A follow-up intervention component to maintain the motivation of those interviewed, with more frequent contacts initially, with at least annual review visits."
15951193|NCT03254966|Drug|SHR0302|Oral tablets
15951194|NCT03254966|Drug|Placebo|Oral tablets
15951195|NCT03254953|Behavioral|self-monitoring of body weight|- weigh daily for 3 months and track their weight using the MyFitnessPal mobile app
15951196|NCT03254953|Behavioral|self-monitoring of diet|"track their diet (food and drinks) daily using the MyFitnessPal mobile app
~when they are asked to track diet will vary based on the arm"
15951197|NCT03254953|Behavioral|weekly personalized feedback + lessons + action plans|- these are additional evidence-based intervention components
15951198|NCT03254940|Behavioral|Charge|Text messaging-based study to determine effect of different components on weight loss.
15951199|NCT03254927|Drug|CDX-3379 and cetuximab|Dose: 12 mg/kg CDX-3379 once every 3 weeks in combination with 400 mg/m2 cetuximab on the first day followed by weekly doses of 250 mg/m2 cetuximab.
15951200|NCT03254914|Procedure|Home Blood Pressure|Measure Home Blood Pressure
15951201|NCT03254901|Other|Screening test by Oraquick test|The OraQuick assay uses an indirect immunoassay method to detect hepatitis C antibodies in oral fluid or blood
15951202|NCT03254875|Behavioral|Individually tailored nurse navigation|The intervention consists of systematic report of symptoms to the nurse and up to six individual, manual-based, face-to-face or telephone nurse navigator sessions depending on individual needs.
15951203|NCT03254862|Procedure|CSS/AsynS|16 sessions of training over a 4 week period consisting of repeated intermittent electrical stimulation (300ms On and 700ms Off stimulation) for 10 - 30 minutes. Conventional synchronous stimulation (CSS) on one leg; Asynchronous Sequential Stimulation (ASynS) on the other leg
15951204|NCT03254862|Procedure|CSS/AsynR|16 sessions of training over a 4 week period consisting of repeated intermittent electrical stimulation (300ms On and 700ms Off stimulation) for 10 - 30 minutes. Conventional synchronous stimulation (CSS) on one leg; Asynchronous Random Stimulation (ASynR) on the other leg.
15951205|NCT03254849|Drug|Empagliflozin|1 tablet
15951206|NCT03254849|Drug|Hydrochlorothiazide 25 mg|1 tablet
15951207|NCT03254836|Other|Standard of care|Elective radical surgery for adenocarcinoma.
15951208|NCT03254810|Biological|SYN060|a single subcutaneous 0.57 mg/kg dose of SYN060
15951209|NCT03254810|Biological|Adalimumab North American source|a single subcutaneous 0.57 mg/kg dose of adalimumab (Humira®) reference product from North American source
15951210|NCT03254810|Biological|Adalimumab European source|a single subcutaneous 0.57 mg/kg dose of adalimumab (Humira®) reference product from European source
15951249|NCT03254537|Dietary Supplement|Mediterranean conventional|Traditional Mediterranean diet comprised of conventional ingredients
15951250|NCT03254524|Other|Statewide Planning and Research Cooperative System Database|The Statewide Planning and Research Cooperative System (SPARCS) is a comprehensive data reporting system created to collect information on discharges from hospitals. SPARCS currently collects patient level detail on patient characteristics, diagnoses and treatments, services, and charges for every hospital discharge, ambulatory surgery patient, and emergency department admission in New York State.
15951211|NCT03254797|Other|Stepping training with feedback|Subjects stand in a step standing position with placing one leg on the load cells of the device and the other leg at the posterolateral direction to the trained leg outside the load cells, look at the displayed section which will be positioned at their eye level. Then subjects will be instructed to shift/take their body-weight onto the trained leg until the green zone of the displayed section is lightened. When the subjects can take a proper level of their body-weight onto the trained leg, the beep sound will be alarmed to trigger the subjects and therapist that the subjects can step the other leg forward to the marker. Then they have to do the same when steps the leg backward.
15951212|NCT03254797|Other|Stepping training without feedback|Subjects stand in a step standing position with placing one leg on the load cells of the device and the other leg at the posterolateral direction to the trained leg outside the load cells. Then subjects will be instructed to shift/take their body-weight onto the trained leg as most as they can. If the subjects can take a proper level of their body-weight onto the trained leg, the subjects can step the other leg forward to the marker. Then they have to do the same when steps the leg backward.
15951213|NCT03254784|Drug|BMS-986165 Capsule|Oral capsule
15951214|NCT03254784|Drug|BMS-986165 Tablet|Oral tablet
15951215|NCT03254771|Other|Decision aid|Decision aids are tools that enables to promote and facilitate patients' involvement in medical decisions concerning their health
15951216|NCT03254758|Biological|Mesenchymal stem cell|"Phase1 The dose of AD-MSCs are escalated from low to mid and high step by step. Each administration is one time via intravenous infusion for one hour.
~Phase2 The recommended dose of ADR-001 is administrated once a week 4 times. The administration route and time is same method with Phase 1."
15951217|NCT03254745|Other|Pharmacist led pharmaceutical care|The intervention in the study will be a pharmacist's intervention that will be provided to rheumatoid arthritis patients in order to improve their treatment outcomes. It will be in the form of a single (1) session by pharmacist (face-to-face) followed by written material for use at home. The pharmacist will look at the patient's baseline data and provide counseling. The venue for counseling will be the hospitals.
15951218|NCT03254732|Drug|ADI PEG20|ADI is a recombinant protein cloned from M. hominis and produced in E. coli, and conjugated with PEG of 20,000 mw. Thus ADI-PEG 20 is an arginine degrading enzyme, ADI, coupled to PEG.
15951219|NCT03254732|Drug|Pembrolizumab|Pembrolizumab is a PD-1 blocking antibody indicated in the USA for the treatment.
15951220|NCT03254719|Other|Study assessments|All participants will be asked to complete study assessments at baseline visit, and weeks 3, 5, 7, and 10. Study participants will receive spinal manipulation and appropriate adjunctive therapies provided by doctors of chiropractic.
15951221|NCT03254706|Other|Peak etch-and-rinse (P1)|Application Mode - Peak Adhesive system applied according to the manufacturer's instructions.
15951222|NCT03254706|Other|Peak applied for double time(P2X)|Application Mode - Peak Adhesive system applied according to the manufacturer's instructions, but for the double time.
15951223|NCT03254706|Other|Single Link etch-and-rinse (SL1)|Application Mode - Single Link Adhesive system applied according to the manufacturer's instructions.
15951224|NCT03254706|Other|Single Link double time (SL2X)|Application Mode - Single Link Adhesive system applied according to the manufacturer's instructions, but for the double time.
15951225|NCT03254693|Combination Product|1-step self-etch approach (SE)|Application mode - Do not use etchan. According to the manufacturer's instructions.
15951226|NCT03254693|Combination Product|selective enamel etching (SEE)|Application mode - Etch only on enamel for 15 s. Rinse for 15s. Air dry to remove excess water.According to the manufacturer's instructions.
15951227|NCT03254693|Other|1-step self-etch for double time (SE2X)|Application mode - Do not use etchan. According to the manufacturer's instructions, but for the double time (20 s) in the each application.
15951228|NCT03254693|Other|1-step self-etch additional layer (SE1+)|Application mode - Do not use etchan. According to the manufacturer's instructions, but apply tree times.
15951229|NCT03254680|Dietary Supplement|Turmeric|Twenty patients will be enrolled and treated with a stable dose of orally administered turmeric oil daily for 3 months.
15951230|NCT03254667|Biological|Brodalumab|Brodalumab
15951231|NCT03254667|Drug|Comparator Drug (non-biologic IL-17 inhibitors)|Comparator subjects treated with non-biologic IL-17 inhibitors
15951232|NCT03254654|Drug|Vinorelbine|Experimental: 20 mg/m2, D6, D13, D20 Active Comparator: 25 mg/m2, D1, D8, D15
15951233|NCT03254654|Drug|Apatinib|250 mg/d, D1-5, D8-12, D15-19. The starting dose will be 250mg/d in the first cycle, if tolerable, 500 mg/d will be administered from the cycle 2.
15951234|NCT03254641|Drug|human chorionic gonadotropin|5000 IE times one
15951235|NCT03254628|Other|Helping Mothers Survive - Bleeding After Birth training|One-day training in postpartum hemorrhage prevention and treatment; this includes instruction to provide oxytocin within one minute of birth to prevent postpartum hemorrhage.
15951236|NCT03254628|Other|Helping Babies Breathe|One-day training in neonatal asphyxia management; this includes routine care for the newborn, such as drying and stimulation immediately after birth, and resuscitation of asphyxiated newborns using a bag & mask device.
15951237|NCT03254628|Behavioral|Mentor|A birth attendant in the facility is designated as a clinical mentor and encouraged to lead simulator-based practice sessions in the facility after training day.
15951238|NCT03254628|Behavioral|Phone|District trainers telephone clinical mentors and encourage them to lead practice sessions.
15951239|NCT03254628|Drug|oxytocin and misoprostol|This study did not provide uterotonic drugs except in the case of stock out where locally purchased oxytocin and misoprostol were provided only as back up.
15951240|NCT03254628|Device|Newborn bag and mask|All facilities were supplied with at least 1 bag and mask for newborn resuscitation. This bag and mask was used for training, practice, and clinical care
15951241|NCT03254615|Behavioral|"I Prefer Plain Water"|The students will receive four educational sessions of approximately 1 hour. These sessions will be given every 2 weeks, and some will be supervised by a nutritionist.
15951242|NCT03254602|Device|Intense Therapeutic Ultrasound Treatment|
15951243|NCT03254589|Drug|Methotrexate|See arm descriptions
15951244|NCT03254589|Drug|Sulfasalazine|See arm description
15951245|NCT03254589|Drug|Other DMARDs|See arm
15951246|NCT03254576|Other|Functional MRI|
15951324|NCT03254004|Drug|Pembrolizumab|pembrolizumab 200 mg every 3 weeks till 1 year or disease recurrence or intolerable toxicity.
15951251|NCT03254511|Drug|Enoxaparin Sodium 40 MG/0.2 ML Subcutaneous Injectable|Patients are going to receive subcutaneouse Enoxaparin (40 mg daily).
15951252|NCT03254511|Radiation|Radiotherapy|Patients will be treated with 3D conformal radiotherapy. The median treatment dose will be 50.40 Gy in 25 to 32 fractions.
15951253|NCT03254511|Drug|Chemotherapeutic Combinations|Patients are going to receive weekly chemotherapy (paclitaxel [50 mg/m2] plus carboplatin [area under the carve=2]).
15951254|NCT03254498|Device|Endocuff|It is a randomised back to back study to compare cap and Endocuff to detect adenoma in colonoscopic examination
15951255|NCT03254498|Device|cap assisted colonoscopy (CAC)|cap assisted colonoscopy (CAC)
15951256|NCT03254485|Drug|IW-1973|Oral Tablet
15951257|NCT03254485|Drug|Placebo Oral Tablet|Oral Tablet
15951258|NCT03254472|Diagnostic Test|Measured concentrations of biomarkers|
15951259|NCT03254459|Drug|Buprenorphine Sublingual Spray|0.5 mg Sublingual Spray
15951260|NCT03254459|Drug|Morphine|4 mg Intravenous Injection
15951261|NCT03254459|Drug|Oxycodone Hydrochloride|10 mg tablet
15951262|NCT03254459|Drug|Zofran|4 mg oral disintegrating tablet (ODT) or IV injection given at the investigator's discretion for nausea
15951263|NCT03254446|Drug|TRC150094|TRC150094 Tablet 45 mg
15951264|NCT03254446|Drug|Placebo|Matching Placebo Tablet
15951265|NCT03254433|Behavioral|BAS+|The goal of the BAS+ is to maintain a level of overall reward after cessation by structuring and enhancing opportunities for reinforcement to: (1) ensure that not smoking is as reinforcing as smoking; and (2) prevent an over-reliance on food as a substitute reinforcer for smoking so that PCWG does not precipitate smoking relapse.
15951266|NCT03254433|Behavioral|SC|Overeating and weight gain are common concerns reported during smoking cessation treatment. Per convention, SC will address these concerns through standard recommendations to consume low-calorie snack foods, drink water, eat nutritious meals, and exercise, but will not include skills to shape the use of these suggestions.
15951267|NCT03254420|Device|Calypso beacon implant|Calypso beacon implant before radiotherapy
15951268|NCT03254420|Radiation|moderate hypofractionation Radiotherapy|moderate hypofractionation Radiotherapy
15951269|NCT03254407|Other|Screening medical record|Communicating possible IV/PO switch to prescriber by phone or e-note in medical record
15951270|NCT03254394|Drug|Lidocaine Hydrochloride|"Intravenous lidocaine will be dosed as a brief 1 mg/kg infusion (based on Ideal Body Weight (IBW)) over 10 minutes, followed by a 0.04 mg/kg/min infusion over additional 120 minutes, resulting in a total dose of 5.8 mg/kg IBW.
~If this dose is tolerable in four consecutive sessions of mFOLFOX6 in six or more of the eight patients in the tolerability phase, we will initiate the randomized efficacy pilot study."
15951271|NCT03254394|Drug|Placebo|Dextrose 5% in water will be administered as active comparator.
15951272|NCT03254394|Drug|FOLFOX regimen|"Each cycle (repeated every 14 days):
~Oxaliplatin 85mg/m2 IV over 2h, Leucovorin 400 mg/m2 IV over 2h, 5-FU 400mg/m2 IV bolus, followed by a 1200mg/m2/day continuous infusion for 2 days."
15951273|NCT03254381|Behavioral|Resistance Training|Six months of thrice-weekly resistance training that will gradually progress in intensity. Each training session will be 60 minutes (10 minutes of warm-up, 40 minutes of training, and 10 minutes of cool-down). Classes will be group classes, with up to five participants in each.
15951274|NCT03254381|Behavioral|Balance and Tone Training|Six months of thrice-weekly stretching and relaxation exercises. Each session will be 60 minutes. Classes will be group classes, with up to five participants in each.
15951275|NCT03254368|Drug|ZGN-1061|ZGN-1061 is a methionine aminopeptidase 2 inhibitor
15951276|NCT03254368|Drug|Placebo|Placebo has the same excipients and appearance as ZGN-1061
15951277|NCT03254355|Procedure|Multimodal physiotherapy|12 weeks of weekly physiotherapy treatments including education segment, electrical stimulation and PFM exercises consisting of strength, endurance and coordination exercises accompanied by biofeedback
15951278|NCT03254329|Other|Assessment of human milk nutrient composition|Observational study to measure nutrients in human milk during lactation and their relationship to maternal and infant nutritional status.
15951279|NCT03254303|Other|Difficulty of catheterization in group 60 s|
15951280|NCT03254303|Other|Difficulty of catheterization in group 90 s|
15951281|NCT03254303|Other|Difficulty of catheterization in group 120 s|
15951282|NCT03254290|Biological|NeoMTA|A new formulation of MTA was developed in which bismuth oxide was omitted.
15951283|NCT03254290|Biological|Formocresol|Control group
15951284|NCT03254277|Drug|3BNC117-LS|Intravenous infusion of 3BNC117-LS
15951285|NCT03254277|Drug|Placebo|Placebo
15951286|NCT03254264|Behavioral|Early Start Denver Model|"ESDM is a comprehensive relational, developmental and behavioral intervention. It's described in a manual for professional (Rogers et al, 2010).
~Children receive ESDM at minimum 12H per week by trained therapist. Therapist work in collaboration with parents (at home) and preschool or nursery."
15951287|NCT03254264|Behavioral|'as-usual' intervention|a control group receiving typical heterogeneous 'as-usual' intervention proposed by professionals and public services over the same period.
15951288|NCT03254251|Behavioral|Stair climbing|Stair climbing (SC) training was 12 weeks of progressive SC program. Each training session consisted of a general warm-up (5 min: slow and fast skipping, stretching) followed by the SC training and was supervised by experienced personnel. The program began with two bouts of stair climbing four days a week in weeks 1 and 2, increasing by one climb a day every three weeks. By the last three weeks (10-12) of the study, all subjects were completing 5 climbs four days a week. During each climb participants ascended 12 flights (192 steps) divided into 3 sets of 4 flights, with a 2 min rest period between each set. There was a 5 min rest period between climbs that allowed the participants to reach the ground floor using an elevator. Subjects in the non-exercising control group did not participate in a supervised exercise program for the duration of the study.
15951289|NCT03254238|Other|Monitoring prEscriptiondruG Abuse using DOctor Shopping bEhavior|development and identification of systems and tools able to detect earlier misuse phenomenon
15951290|NCT03254225|Behavioral|Resistance training|Resistance training performed three times at week for 16 weeks, in 8 exercises for the main muscles, the protocol of 3 sets of 10 repetitions with intensity of 50% of 1 maximum repetition (MR).
15951325|NCT03253991|Device|MRgFUS treatment|ExAblate Transcranial MRgFUS Thalamotomy Treatment of Medication Refractory Essential Tremor Subjects
15951291|NCT03254212|Device|Titration of nocturnal oxygen needs to prevent desaturations|Oximetry recordings will be performed using a Pulse Oximeter. Two O2 titration sessions will be conducted at home in random order one week apart. One will consist of a stepwise night-to-night increase in O2 flow for up to 4 nights with supplemental O2, each at flow rates of 1L/min, 2L/min, 3L/min and 4L/min, respectively. During the other titration session, an automatic O2 delivery system will be used for 4 consecutive nights with O2 flow allowed to vary from 0 to 4 L/min with a 95 ± 2% SpO2 target. At the end of the titration periods, oxygen concentrators will be set at the lowest flow rate (1L/min to 4L/min) that maintained oxyhemoglobin saturation to > 90% (Tsat90%) for ≥ 98% of the estimated sleep period and reduced the oxygen desaturation index 3% (ODI3) to < 5/hour according to conventional O2 titration. If these targets are not reached, the lowest flow rate will be selected that minimizes the ODI3. These procedures will be repeated at week 5 and 11.
15951292|NCT03254199|Drug|FLX-787-ODT (orally disintegrating tablet)|FLX-787-ODT taken three times daily for 28 days
15951293|NCT03254199|Drug|Placebo ODT|Placebo ODT taken three times daily for 28 days
15951294|NCT03254186|Drug|Propranolol Hydrochloride|Propranolol is started 10 mg tablet twice per day per oral, two week up-titration to reach a total dose of 20mg per oral four times per day over the first two weeks, then will remain on a stable dose for six weeks.
15951295|NCT03254186|Drug|Placebo Oral Tablet|Identical placebo is started one tablet twice per day per oral, increase over the first two weeks to reach one tablet four times per day, then will remain on this dose for six weeks.
15951296|NCT03254173|Drug|Mirtazapine 30 mg oral tablets|Mirtazapine 30 mg oral tablets ( Remeron 30 mg oral tablets) , half tablet before sleep for 8 weeks
15951297|NCT03254173|Drug|Placebo oral tablets|Placebo oral tablets , half tablet daily before sleep for 8 weeks
15951298|NCT03254160|Drug|DNS-3379|DNS-3379
15951299|NCT03254160|Drug|Placebo|Placebo
15951300|NCT03254147|Drug|warfarin|warfarin
15951301|NCT03254147|Drug|dabigatran|Non-vitamin K dependent oral anti-coagulants (NOACs)
15951302|NCT03254147|Drug|Apixaban|Non-vitamin K dependent oral anti-coagulants (NOACs)
15951303|NCT03254147|Drug|Edoxaban|Non-vitamin K dependent oral anti-coagulants (NOACs)
15951304|NCT03254147|Drug|Rivaroxaban|Non-vitamin K dependent oral anti-coagulants (NOACs)
15951305|NCT03254134|Drug|Warfarin|patients treated with warfarin
15951306|NCT03254134|Drug|Dabigatran|patients treated with Dabigatran
15951307|NCT03254108|Drug|OPC-61815 injection 2mg|Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 2 mg.
15951308|NCT03254108|Drug|OPC-61815 injection 4mg|Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 4 mg.
15951309|NCT03254108|Drug|OPC-61815 injection 8mg|Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 8 mg.
15951310|NCT03254108|Drug|OPC-61815 injection 16mg|Once daily for 5 days placebo tablet will be orally administered, followed immediately by intravenous administration of OPC-61815 at 16 mg.
15951311|NCT03254108|Drug|Tolvaptan tablet 15mg|Once daily for 5 days tolvaptan 15-mg tablet will be orally administered, followed immediately by 1-hour intravenous administration of placebo.
15951312|NCT03254082|Other|Glycemic response of F-1000|The intervention was to determine if different flours elicit similar or different (change from baseline) 2 hour glucose responses (e.g., similar to glycemic index) after eating.
15951313|NCT03254082|Other|Glycemic response to sumac sorghum flour|The intervention was to determine the two hour change from baseline glucose responses (e.g., similar to glycemic index) after consuming sumac sorghum flour as a gruel.
15951314|NCT03254082|Other|Glycemic response to MMR sorghum flour|The intervention was to determine the two hour change from baseline glucose responses (e.g., similar to glycemic index) after consuming MMR sorghum flour as a gruel.
15951315|NCT03254082|Other|Glycemic response to wheat flour|The intervention was to determine the two hour change from baseline glucose responses (e.g., similar to glycemic index) after consuming wheat flour as a gruel.
15951316|NCT03254082|Other|Glycemic response to sucrose|The intervention was to determine the two hour change from baseline glucose responses (e.g., similar to glycemic index) after consuming sugar (dissolved in water)
15951317|NCT03254069|Device|Stainless Steel Crowns|SSCs were placed on children's primary molars, and bite force was registered prior to the study, and periodically after the study.
15951318|NCT03254056|Procedure|Conventional technique|Conventional technique: In this group; S-retractors will be used to visualize the fascia and a single interrupted stitch will be placed using 0-vicryl suture.
15951319|NCT03254056|Procedure|Berci technique|Berci group: In this group; the fascial incision will be closed with the fascial closure device, (Berci Fascial Closure instrument) using 1 interrupted stitch with 0-vicryl suture.
15951320|NCT03254043|Behavioral|Take-home Dosing Procedures|Within-subject evaluation across 2 phases with a final choice condition
15951321|NCT03254030|Other|Colonic inspection|Participants who are randomised to undergo the intervention will have the colonic mucosa examined during inspection and withdrawal phase of examination
15951322|NCT03254017|Procedure|Bilateral surgical implantation of DBS system to Habeluna|The SceneRay DBS device utilized in the present study is a double-channel device designed and manufactured by Suzhou Scene-Ray Medical Co., Ltd. The DBS system includes a dual-channel neurostimulator kit, lead kit, extension kit, clinician-operated wireless programmer, test stimulator, and patient controller. The lead (diameter =1.27 mm) contains four stimulating contacts made of platinumiridium alloy. The length of each contact is 1.5 mm, and interval spaces are 0.5 mm. This device shares the same basic principles utilized by Medtronic products, with unique wireless programming and electrode fixing designs. The amplitude (0-10 V), pulse width (60-960 ms), and frequency (1-1,600 Hz) can be programmed, and different frequencies may be utilized in the left and right hemispheres using this type of dual-channel IPG.
15951323|NCT03254017|Other|Follow-up Period|The researchers will remotely program the DBS biweekly after opening the stimulator and face to face test the patients' cognitive function every half year. Montgomery-Asberg Depression Rating Scale will be tested biweekly until the Programmed parameter has stable therapeutic efficacy and then tested after 3 months, 6 months, 9 months and 12 months.The other neuropsychological scales will be test on 3 months, 6 months, 9 months and 12 months.
15984666|NCT03003247|Drug|IDP 120 Component B Gel|Monad of Component B
15951330|NCT03253965|Other|Music Normal|Steps are timed with the beat of the music by a rhythm consistent with the subject's cadence
15951331|NCT03253965|Other|Music Slow|Steps are timed with the beat of the music by a rhythm consistent with 85% of the subject's cadence
15951332|NCT03253965|Other|Music Fast|Steps are timed with the beat of the music by a rhythm consistent with 115% of the subject's cadence
15951333|NCT03253965|Other|No Auditory cueing|Steps are not timed with any auditory cue.
15951334|NCT03253939|Procedure|Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure|Cytoreductive surgery combined with hyperthermic intraperitoneal chemotherapy procedure
15951335|NCT03253939|Procedure|Cytoreductive surgery alone|Exclusively Cytoreductive surgery approach
15951336|NCT03253926|Drug|Lorcaserin|Lorcaserin 10mg BID
15951337|NCT03253926|Drug|Placebo|Placebo capsule BID
15951338|NCT03253926|Drug|Marijuana|Smoked marijuana cigarette
15951339|NCT03253913|Drug|Sirolimus|Patients will be on a stable dose of sirolimus prior to enrolling and will continue that throughout the study.
15951340|NCT03253913|Drug|Resveratrol|Escalating doses of resveratrol will be given throughout the study. Patients will start at 250mg daily for 8 weeks, followed by 500mg daily for 8 weeks, and 500mg BID for the last 8 weeks.
15951341|NCT03253900|Device|Stable rowing simulator|a standard stable/fixed rowing simulator
15951342|NCT03253900|Device|Slides based rowing simulator|a slides based rowing simulator, i.e. horizontal plane unstable
15951343|NCT03253900|Device|Tilt board based rowing simulator|a tilt board based rowing simulator; i.e. frontal plane unstable
15951344|NCT03253887|Drug|Ethanol-lock|This group received daily alcohol 70% (ethanol-lock) received intraluminal ethanol at a volume sufficient to fill the catheter lumen, ranged from 0.1 to 0.3 ml, with the volume being previously established. ELT was maintained for two full hours in each catheter lumen, with the lumen remaining locked during this period. The same procedure was then carried out with the other lumen. Prior to and following ELT, flushing was performed using 5-10 ml of 0.9% saline solution.
15951345|NCT03253874|Behavioral|No Pre-Op Testing for Cataract Surgeries|Supported by the American Board of Internal Medicine's Choosing Wisely™ campaign to reduce low value care , the interventions aims to reduce pre-operative visits and testing for patients undergoing cataract surgeries.
15951346|NCT03253861|Other|No intervention|No intervention
15951347|NCT03253848|Other|Best Practice|Discussion between doctors and APL expert
15951348|NCT03253848|Other|Laboratory Biomarker Analysis|Correlative studies
15951349|NCT03253848|Procedure|Supportive Care|Receive simplified guidelines and support
15951350|NCT03253835|Diagnostic Test|Single Group Assignment|
15951351|NCT03253822|Other|Decision aid|The DA is an online tool. The web-based design opens up possibilities to feature more advanced functions, e.g. questions for the participant during the process, and a summary of answers at the end. The DA is tailored to lower educational attainment citizens, and is designed to embrace different information needs in the target population, ranging from a desire to receive a clear recommendation and a minimum of information to the desire to receive full information and make a personalized choice.
15951352|NCT03253809|Device|Biotronik Vision Guidewire|The apical, mid ventricular and basal sites within the anterior,posterior and lateral coronary sinus branch veins will be paced.
15951353|NCT03253796|Biological|Golimumab QM: Period 1 (OL)|OL monthly injections of active golimumab 50 mg or 100 mg (two 50 mg injections) from Month 0 to Month 9 (Period 1, run-in)
15951354|NCT03253796|Biological|Golimumab QM: Period 2 (DB)|"DB monthly injections of active golimumab 50 mg or 100 mg (two 50 mg injections) for 12 months, or until flare (Period 2, full treatment)"
15951355|NCT03253796|Biological|Golimumab Q2M: Period 2 (DB)|"DB monthly injections of golimumab 50 mg or 100 mg (two 50 mg injections), alternating with placebo, for 12 months, or until flare (Period 2, reduced treatment)"
15951356|NCT03253796|Other|Placebo QM: Period 2 (DB)|"DB monthly injections of placebo for golimumab for 12 months, or until flare (Period 2, treatment withdrawal)"
15951357|NCT03253796|Biological|Golimumab QM: Period 2 (OL)|"OL golimumab 50 mg or 100 mg (two 50 mg injections) for 12 months (Period 2, full treatment re-started after flare)"
15951358|NCT03253783|Behavioral|Pulse|
15951359|NCT03253770|Device|SIMMAX2|Digital cognitive aid or paper cognitive aid during the management of a cardiac arrest in the recovery room or in the delivery room.
15951360|NCT03253757|Other|This study is non-interventional.|This study is non-interventional.
15951361|NCT03253744|Drug|18F-DCFPyL|Subjects will receive 18F-DCFPyL at baseline and 6 months after radiation. The maximum amount of injected active drug will be less than 4.02 micrograms. The target administered activity will be 6-6.5 mCi.
15951362|NCT03253744|Radiation|Tumor Irradiation|SBRT will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy
15951363|NCT03253744|Radiation|Prostate radiation + tumor boost irradiation|SBRT will be delivered to areas of recurrent prostate cancer identified on imaging and biopsy; and a reduced dose will be delivered to the entire prostate
15951364|NCT03253679|Drug|Adavosertib|Given PO
15951365|NCT03253666|Other|Nutrient Intake|Dietary nutrient intake (such as folate) and supplemental nutrient intake (such as folic acid)
15951366|NCT03253653|Device|Waterpipe smoking|In a repeated measures design, 50 adult male and female exclusive WP tobacco smokers will smoke WP tobacco weekly over a 3-week study period with 3 WP smoking practices as follows: 1) using room temperature water in the WP jar, 2) adding ice cubes to the water in the WP jar, and 3) using a charcoal-free electronic WP head to heat the tobacco. Six Spot first morning urine samples will be provided by participants. Two urine samples per each of the 3 smoking sessions. Urine samples will be provided on the day of the WP tobacco smoking session and the following day. Physiological measures will be taken at Baseline during the office visit and before and after each of the 3 WP tobacco smoking sessions.
15951367|NCT03253640|Other|Exposure|Healthcare associated infection (HAI)
15951368|NCT03253627|Behavioral|Health Enhancement Program|The HEP control, which was developed to serve as an active control to MBSR, will receive manualized health education from experts in physical activity, functional movement, music therapy, and nutrition-without mindfulness instruction-using similar modalities to MBSR training for a matched schedule.
15951401|NCT03253328|Drug|Active Arm N-acetyl cysteine (NAC)|N-acetyl cysteine (NAC) 1200mg twice a day for 6 days post-amputation
15984667|NCT03003247|Drug|IDP 120 Vehicle Gel|Vehicle
15951369|NCT03253627|Behavioral|Mindfulness-Based Stress Reduction|The MBSR group will receive training from a certified instructor during a group-based, 2.5-hour manualized educational activity weekly for eight weeks. Activities include body scans, gentle stretching, yoga, and mindful awareness. Participants will be asked to complete daily 45-minute, audio-guided mindfulness activities and a one-day weekend retreat to reinforce learning.
15951370|NCT03253614|Diagnostic Test|Audiometry|Extended high-frequency (EHF; 9-16 kHz) audiometry
15951371|NCT03253614|Diagnostic Test|Urine biomarkers for renal tubular function|Kidney Injury Molecule-1
15951372|NCT03253614|Diagnostic Test|Blood pressure|Blood pressure right arm, measured With standard Methods 3 times
15951373|NCT03253601|Behavioral|Strategy Training|Strategy training is a form of meta-cognitive instruction that trains individuals with stroke-related cognitive impairments to identify and prioritize problematic daily activities, identify the barriers impeding performance, generate and evaluate their own strategies to address barriers, and apply these skills through iterative practice.
15951374|NCT03253588|Procedure|laparoscopic salpingotomy or salpingostomy|A 3-port technique (2 x 5-mm and 1 x 10-mm trocars) was implemented. A diluted solution of vasopressin (20IU in 100 mL saline solution) was initially injected into the mesosalpinx of the affected tube, followed by a linear incision which allowed the removal of the gestational tissue. In case of a ruptured tubal pregnancy, the ectopic mass was evacuated directly from the ruptured site using a combination of forceps and suction device. The tubal lumen was either closed with a single-layer of continuous absorbable suture (salpingotomy) or left to heal by secondary intention (salpingostomy).
15951375|NCT03253575|Diagnostic Test|CANscript|CANscript is a predictive test that supports informed selection of cancer therapeutics for each individual patient. CANscript has the potential to predict the response of the patient under evaluation to either single-agent cancer therapeutics or combination therapeutic regimens. This is accomplished by using fresh tumor tissue from the patient in plates coated with a specific set of tumor matrix proteins (TMP). Further, patient derived autologous ligands are added to the culture. Angiogenic factors are added to maintain tumor vasculature along with autologous immune cells. In essence, CANscript recapitulates the tumor microenvironment.
15951376|NCT03253562|Drug|Metformin Pill|a biguanide used as an insulin sensitizer for patients suffering from type 2 diabetes mellitus
15951377|NCT03253562|Drug|Vildagliptin 50 mg|Dpp4i antihyperglycemic drug used for treatment of type 2 diabetes mellitus
15951378|NCT03253549|Device|SMArTVIEW|Remote automated, continuous monitoring in hospital after cardiac or vascular surgery, followed by 30-day at home monitoring, daily nurse video visits and a self-management training program.
15951379|NCT03253536|Other|observational|none (observational study)
15951380|NCT03253523|Procedure|Occipital neurolysis|Surgical occipital nerve decompression
15951381|NCT03253510|Other|Poly-amide|New denture base material that exhibit high flexibility, physical strength, heat and chemical resistance and the exceedingly rare allergy response
15951382|NCT03253510|Other|Poly-methyl methacrylate|Gold standard denture base material
15951383|NCT03253497|Drug|Chlorobenzene Liquid|before induction will be used for oropharynx
15951384|NCT03253484|Radiation|NAFL-treatment|non ablative fractional laser 15 40 nm promoting wound healing and reduction of scar formation
15951385|NCT03253471|Drug|AL-611|AL-611 tablets
15951386|NCT03253471|Drug|Placebo|Placebo to Match AL-611
15951387|NCT03253458|Device|Confocal Laser Endomicroscopy|Transperineal confocal laser endomicroscopy or optical coherence tomography measurements. Probe will be placed guided by ultrasound, similar procedure as transperineal template guided mapping biopsies.
15951388|NCT03253445|Behavioral|Acceptance and commitment therapy|All participants are given a brief educational talk on encouraging quitting smoking (about 5 mins) and a self-help leaflet on smoking cessation. Ten sessions of face-to-face ACT individually will additionally be provided by trained therapists on a weekly basis. Each session will last about 20-30 minutes. The therapy is guided by ACT smoking cessation protocols based on relevant literature (Gifford et al 2004, 2011; Bricker, 2010).
15951389|NCT03253445|Other|Control|All participants are given a brief educational talk on encouraging quitting smoking (about 5 mins) and a self-help leaflet on smoking cessation. Ten sessions of face-to-face Social Support will additionally be provided on a weekly basis. Each session will last about 5 minutes.
15951390|NCT03253432|Other|Genetic testing|Targeted next-generation sequencing for familial hypercholesterolemia causative mutations
15951391|NCT03253419|Other|Home for Life mobile application|Utilize home application to provide the participant with an understanding and recommendations to potentially decrease home hazards that may lead to risk of falls in their home.
15951392|NCT03253406|Behavioral|Polar M400 + Facebook Group (PM400+FG)|Throughout the intervention period experimental group participants will be asked to read and try to implement the twice-weekly physical activity- and nutrition-related health tips posted to the group's Facebook page. Additionally, experimental group participants will be asked to track all physical activity with the Polar M400 smartwatch and use this information to set physical activity-related goals conducive to improved health.
15951393|NCT03253406|Behavioral|Facebook Only Group (FG)|Throughout the intervention period comparison group participants will be asked to read and try to implement the twice-weekly physical activity- and nutrition-related health tips posted to the group's Facebook page.
15951394|NCT03253393|Device|Smart Touch Technology|hioxifilcon A contact lens in Smart Touch Technology Flat Pack (hydrogel) asmofilcon A contact lens in Smart Touch Technology Flat Pack (silicone hydrogel)
15951395|NCT03253393|Device|Conventional lens packaging|hioxifilcon A contact lens in conventional lens packaging (hydrogel) asmofilcon A contact lens in conventional lens packaging (silicone hydrogel)
15951396|NCT03253380|Other|Early Rehabilitation Program In Critically Ill Chronic Obstructed Airway Disease patients|Early rehabilitation of MV patients in the respiratory ICU
15951397|NCT03253367|Other|Blood is obtained, mostly during routine venipuncture|
15951398|NCT03253354|Device|repetitive magnetic stimulation|Neurostimulation
15951399|NCT03253341|Behavioral|Smart Aging Program|Comprehensive lifestyle and fitness program designed to improve the health of older adults. The Smart Aging Program represents a package consisting of a dedicated health coach, mobile monitoring, specialized curriculum, and exercise opportunities.
15951400|NCT03253341|Behavioral|Educational Materials|Current standard of care. Includes education materials covering benefits of a healthy lifestyle.
15951402|NCT03253328|Drug|Placebo Arm|Placebo 1/2 normal saline infusion twice a day for 6 days post-amputation
15951403|NCT03253289|Drug|Meclizine Oral Tablet|All subjects will receive 50 mg of meclizine taken orally, twice a day (daily dose 100 mg) for 28 (up to 35) days.
15951404|NCT03253276|Drug|Obeticholic acid|Placebo-controlled
15951405|NCT03253276|Drug|Placebos|
15951406|NCT03253263|Drug|SHP607|Participants will receive intravenous infusion of SHP607 at doses of 250 mcg/kg/24 hours and 400 mcg/kg/24 hours from birth up to PMA 29 weeks + 6 days.
15951407|NCT03253250|Drug|ETV；TDF；ADV|NAs
15951408|NCT03253250|Drug|Peginterferon Alfa-2a|peginterferon
15951409|NCT03253237|Device|continuous glucose monitoring (CGM)|A CGM device is to be set and take of by the GP. Before the study start all GPs will have a short education on CGM device by the diabetologist who use CGM on a daily base. Study period is seven days and includes screening before study entry and two visits. On Day 1, after screening and signing the informed consent, the CGM device is applied. Patient is instructed to keep a 7 day diary with four daily standard home blood glucose monitoring (SHBGM) along with the data on eating, physical exercise, drugs. Bayer's Contour® glucometer is used for the SHBGM. On Day 7, CGM device is took of and the data from iPro2 is uploaded to PC. At the end, each patient fill a short query on satisfaction while wearing CGM.
15951410|NCT03253224|Drug|Magnesium Sulfate|Magnesium group receives magnesium sulfate (50 mg/kg) in 100 mL of normal saline over 15 min during induction of anesthesia, followed by a continuous magnesium sulfate infusion (15 mg/kg/h) until the end of surgery.
15951411|NCT03253224|Drug|Normal saline|Normal saline group receives the same volume of normal saline, administered according to the same method as in the magnesium group.
15951412|NCT03253198|Drug|Saline|A preoperative interscalene brachial plexus single-shot block using 25 ml of 0.5% Ropivicaine plus saline injection postoperative
15951413|NCT03253198|Drug|Bupivacaine liposome|an interscalene brachial plexus single shot block preoperatively (25 ml of 0.5% ropivicaine) + Postoperative Infiltration of local anesthetic/analgesic (20 cc Bupivacaine extended-release liposome injection (Exparel) + Diluted in 20cc of Saline into the capsule, subscapularis, deltoid, pectoralis major and subcutaneous tissues)
15951414|NCT03253185|Drug|SC-007|intravenous
15951415|NCT03253172|Dietary Supplement|Potassium Chloride|Two potassium supplements with varying anions.
15951416|NCT03253172|Dietary Supplement|Potassium Citrate|Potassium Citrate
15951417|NCT03253172|Dietary Supplement|Placebo|Placebo
15951418|NCT03253159|Behavioral|Hypnosis|The conversational hypnosis (10-15 min) is standardized and performed just before intravenous general anesthesia induction in the operative room.
15951419|NCT03253146|Diagnostic Test|VIM detection|VIM expression in serum and lymphocytes detection
15951420|NCT03253133|Drug|Oxaliplatin|"Dose levels of Oxaliplatin:
~4 dose levels of Oxaliplatin (85, 100, 130 and 160 mg/m²) are planned. 1 dose level is planned (-1 : 70 mg/m²) if DLT is reached at level 1
~Table 1: Dose levels
~Dose Level Dose (mg/m²) Number of patients DL -1 70 mg 3-6 DL 1 * 85 mg 3-6 DL 2 100 mg 3-6 DL 3 130 mg 3-6 DL 4 160 mg 3-6
~* Start level"
15951421|NCT03253133|Drug|LV5FU or Folfiri|Association of chemotherapy by LV5FU or Folfiri according pratician choice
15951422|NCT03253133|Drug|Oxycodone|Oxycodone
15951423|NCT03253120|Other|Water|Patient/ Healthy volunteer will drink 5dl of Water
15951424|NCT03253107|Drug|Chemotherapy|"Institutinal standard chemotherapy as first line
~: XP (xeloda + cisplantin) or Xelox (xeloda+oxaliplitan) +/- Herceptin"
15951425|NCT03253094|Drug|Fluconazole|Oral Antifungal comparator
15951426|NCT03253094|Drug|SCY-078|Investigational Antifungal
15951427|NCT03253081|Behavioral|PARENT focused intervention|The group will comprise 3 to 4 parents and will focus on psychoeducation and support/well-being for the parent. Sessions will include a 20-minute welcome and supportive discussion where parents can provide updates on their week and seek advice and support from the group, followed by a 45-minute interactive education session focused on the principles of JASPER, and close with a 20-minute Mindfulness session. The Mindfulness session will be led by a certified expert.
15951428|NCT03253081|Behavioral|CHILD focused intervention|The session will be divided into 30-minute segments and include two 30-minute individualized 1-on-1 sessions with a trained interventionist. One of these two sessions will involve the parent in hands-on training while the other will be interventionist-led while the parent observes. The remaining 30-minutes will include a snack for the child and time for the parent to discuss and ask questions of the interventionist regarding the session content.
15951429|NCT03253068|Drug|Pembrolizumab plus amurubicin|Pembrolizumab 200mg/body plus amurubicin 40mg/m2, intravenous, every 3 weeks
15951430|NCT03253055|Radiation|DEXA|Dual energy X-ray absorptiometry (DEXA): a total of two scans will be performed, one for the assessment of whole body bone mineral density and body composition, and the other scan is performed to specifically assess fracture risk by scanning the hip and femoral head. Effective exposure doses for these scans are ~8uSv and ~4uSv respectively.
15951431|NCT03253055|Radiation|pQCT|A total of one scan will be performed on the non-dominant Tibia, the effective exposure dose will be between 1.5-1.8uSV.
15951432|NCT03253055|Other|Lifestyle Questionnaire|Participants are required to record their lifestyle, diet (5-day self reported), physical activity (IPAQ questionnaire), injury and illness incidence.
15951433|NCT03253055|Other|Aerobic Fitness|Aerobic fitness will be tested using a VO2 max exercise protocol using a stationary cycle ergometer, the participants will be expected to perform this to maximal effort or exhaustion.
15951434|NCT03253055|Other|Muscular Strength|Muscular strength of the knee extensor and handgrip muscles will be determined using an Isokinetic Dynamometer and a handgrip dynamometer respectively.
15951435|NCT03253055|Biological|Blood draw and finger prick test|15ml of whole blood will be collected for the measurement of fasting serum 25(OH)D levels, parathyroid hormone, C-terminal telopeptide (CTX) and full blood count
15951436|NCT03253055|Other|Muscular Power|Muscular power will be determined using an optical measurement system consisting of a transmitting and receiving bar to determine jump height through the interpretation of jump flight of the participant (reported in cm). The equipment used is an Optojump.
15951513|NCT03252496|Radiation|Ultrasound Assessment of the Inferior Vena Cava|The inferior vena cava largest and smallest diameters will be measured proximal to the opening of the hepatic veins in the longitudinal axis with the M-mode using a 8-2 MHz curved array ultrasound probe placed longitudinally in the subcostal region
15951437|NCT03253042|Other|WBV exercise program|The intervention will consist of a 8-week whole-body vibration exercise program with the platform configured at a frequency of 40 Hz and peak-to-peak amplitude of 4 mm. The sessions will be held 2 times a week, consisting of 4 sets of 1 and a half minutes of exercise on the platform. Rest intervals of 1 minute between sets will be respected.
15951438|NCT03253042|Other|Sham WBV exercise program|The intervention will consist of a 8-week exercise program, but the platform will remain off at all sessions. A device will be attached to the side of the platform in order to produce a sound, similar to the sound produced by the vibrating platform when it is in operation.
15951439|NCT03253029|Dietary Supplement|Pure Encapsulations Branched Chain Amino Acid powder|
15951440|NCT03253029|Dietary Supplement|control group (no BCAAs provided)|
15951441|NCT03253016|Diagnostic Test|vaginal swab -microbiome test and blood test for cytokines|vaginal microbiome test and blood test for cytokines repeated during pregnancy in the 3 arms
15951442|NCT03253003|Device|Line extension of the Phonak Audéo B product family|The line extension of Phonak Audéo B product family will be fitted to the participants individual hearing loss.
15951443|NCT03252990|Diagnostic Test|PET-MRI|Additional 18F-choline PET-MRI examination
15951444|NCT03252990|Procedure|Optical Coherence Tomography|Additional optical coherence tomography (OCT) examination (during the already planned routine PCI procedure)
15951445|NCT03252977|Other|Tailored regimen of IV PCA according to pain sensitivity|In tailored group, fentanyl dosage in IV PCA will be determined according to preoperative pain sensitivity. In control, group, fentanyl dosage in IV PCA will be determined without consideration of patient's pain sensitivity.
15951446|NCT03252977|Other|Regimen of IV PCA without considering pain sensitivity|In control group, regimen of IV PCA will be determined without consideration about patient's pain sensitivity.
15951447|NCT03252964|Device|Continuous Glucose Monitor (CGM)|Subjects will use a CGM to develop an understanding of how their behaviors influence their glucose levels.
15951448|NCT03252964|Device|Activity Tracker|Subjects will use the activity tracker, in combination with a continuous glucose monitor (CGM), to develop an understanding of how their activity levels affect their glucose levels.
15951449|NCT03252964|Behavioral|Coaching|Coaches will help subjects understand the readings from the CGMs and how they are affected by diet choices, use of diabetes medications, etc. Coaches and subjects will have weekly conversations about CGM data and behaviors that affect CGM readings. Coaching will occur via telephone, text messaging, and automated text messaging.
15951450|NCT03252951|Behavioral|Eccentric Training|Different Anal Sphincter Exercise Types for muscle hypertrophy
15951451|NCT03252951|Behavioral|Concentric Training|Different Anal Sphincter Exercise Types for muscle hypertrophy
15951452|NCT03252951|Behavioral|Isometric Training|Different Anal Sphincter Exercise Types for muscle hypertrophy
15951453|NCT03252951|Behavioral|Biofeedback|Standard of Care Biofeedback Training
15951454|NCT03252938|Drug|IMP321|LAG-3Ig fusion protein, highly potent activator of antigen presenting cells
15951455|NCT03252938|Drug|Avelumab|Avelumab i.v.
15951456|NCT03252925|Drug|N-Acetylcysteine|50mg/Kg.d, oral
15951457|NCT03252925|Drug|Placebo Oral Tablet|50mg/Kg.d, oral
15951458|NCT03252912|Biological|blood samples|Two EDTA tubes (5 mL) and two dried tubes (5mL) will be will be taken the same day as the first lumbar .
15951459|NCT03252899|Other|Survey therapists|A survey was conducted among therapists on upper limb treatment after stroke.
15951460|NCT03252899|Other|Survey patients|A survey was conducted among stroke survivors on upper limb treatment after stroke.
15951461|NCT03252886|Procedure|Endotracheal Intubation|Insertion of endotracheal tube into the trachea and supply oxygen using the Ambu-bagging during cardiopulmonary resuscitation
15951462|NCT03252860|Other|Observation of compliance with the World Health Organisation Surgical Safety Checklist|Observation of use and compliance with the surgical safety checklist and associated perioperative surgical outcomes
15951464|NCT03252834|Diagnostic Test|Genetic variants of TRPV1, TRPM2, TRPA1 and ORAI|Genetic variants of TRPV1, TRPM2, TRPA1 and ORAI1 will be analyzed. Quantitative Sensory Test, QST, will be used to determined if there is abnormal thermal sensation.
15951465|NCT03252821|Behavioral|High-intensity interval training|High-intensity interval training sessions will be conducted on cycle ergometers or treadmill with heart rate measured throughout each session.
15951466|NCT03252821|Behavioral|Resistance training|Resistance exercise will be performed on eight exercises targeting major muscle groups at 60% to 85% of their estimated one-repetition maximum (1RM).
15951467|NCT03252808|Biological|TBI-1401(HF10)|1x10^6 or 1x10^7 TCID50/mL TBI-1401(HF10) administered by intratumoral injection at 2-week intervals. Patients may continue to receive the injections for up to 1 year if eligible for injection.
15951468|NCT03252808|Drug|Gemcitabine|1000 mg/m^2 Gemcitabine administered by intravenous infusion at weekly for 3 weeks followed by a week of rest.
15951469|NCT03252808|Drug|Nab-paclitaxel|125 mg/m^2 Nab-paclitaxel administered by intravenous infusion at weekly for 3 weeks followed by a week of rest.
15951470|NCT03252808|Drug|TS-1|TS-1 (40-60 mg per body surface area) administered by oral at twice daily for 4 weeks followed by 2 weeks of rest.
15951471|NCT03252795|Procedure|uterus transplantation|transplantation of a uterus from a deceased donor
15951472|NCT03252782|Device|Herbst Appliance|Acrylic Splint Herbst Appliance
15951473|NCT03252782|Device|Distal Jet Appliance|Anterior Median Palate Implant Borne Distal Jet Appliance
15951474|NCT03252769|Other|Self-sampling|
15951475|NCT03252756|Other|Placebo|600mg Saline (PO) for 4 weeks, immediately followed by 1200mg Saline/ day (PO) for an additional 4 weeks (8 total weeks).
15951476|NCT03252756|Drug|Phytocannabinoid cannabidiol (CBD)|600mg CBD (PO) for 4 weeks, immediately followed by 1200mg CBD/ day (PO) for an additional 4 weeks (8 total weeks).
15951514|NCT03252496|Drug|250 mL Colloid over 5 minutes|6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 250 mL will be administered over 5 minutes starting immediately after intrathecal injection
15951515|NCT03252496|Drug|250 mL Crystalloid over 5 minutes|Ringer acetate 250 mL will be administered over 5 minutes starting immediately after intrathecal injection
15951753|NCT03250572|Diagnostic Test|serum ferritin|serum samples and ferritin ELISA test
15951477|NCT03252743|Behavioral|Exposure-based internet-delivered CBT|"The main target in treatment is exposure for abdominal symptoms by reducing avoidance and provoking symptoms. Participants are encouraged to gradually increase the difficulty by combining multiple challenges.
~The parents are taught how to reduce the risk for reinforcement of children's symptom behavior, and to support their child to complete the treatment.
~All treatment content is delivered over the internet, containing texts, videos, audio-files and examples. The modules are unlocked sequentially as participants worked their way through the treatment.
~Therapist support consists primarily of encouragement of any progress made in the treatment and support to find individual exercises."
15951478|NCT03252730|Other|WO 4260 Cosmetic Product for Topical Use|Application on the hair scalp at least once a day over four weeks
15951479|NCT03252717|Biological|Blood sample|"Pre-treatment blood samples will be collected for downstream analyses:
~Three 6 ml EDTA samples for proteomic and genomic work package
~One 6 ml dry sample for auto-antibodies analysis in the immunology work package
~Two 4 ml EDTA samples for DNA extraction in the immunology work package
~Two 2.5 ml PAX Gene sample for RNA extraction in the immunology work package and the non-irradiated control in the genomic work package"
15951480|NCT03252704|Other|resistant starch (high fiber muffin top)|Muffin top contained 11 g of fiber per portion
15951481|NCT03252704|Other|control (low fiber muffin top)|Muffin top contained 1 g of fiber per portion
15951482|NCT03252678|Other|a book and videos about ACP|A book and three videos about advanced care planning are provided for self-education
15951483|NCT03252678|Other|a book and videos about pain control|A book and three videos about pain control for cancer patients are provided for self-education
15951484|NCT03252665|Drug|Alprostadil|alprostadil,2ug, dilivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients
15951485|NCT03252665|Drug|Nicorandil|Nicorandil,2mg, dilivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients
15951486|NCT03252665|Drug|Nitroglycerin|Nitroglycerin,200ug, dilivered by targeted perfusion catheter in the culprit vessel after PCI in STEMI patients
15951487|NCT03252652|Radiation|vascular duplex ultrasound imaging|Duplex ultrasound is a non-invasive evaluation of blood flow through cranial arteries and veins.
15951488|NCT03252639|Procedure|EVT for RAS & PBV acquisition protocol for target kidneys|
15951489|NCT03252626|Drug|Alprostadil|"Alprostadil injection USP for intravascular infusion contains 500 micrograms Alprostadil, more commonly known as prostaglandin E1. Vasodilation, inhibition of platelet aggregation are among the most notable of these effects.
~2ml Alprostadil injection added into 10ml 0.9% saline."
15951490|NCT03252626|Drug|Normal saline|2ml normal saline injection added into 10ml 0.9% saline.
15951491|NCT03252600|Drug|Cyclophosphamide|Given IV
15951492|NCT03252600|Drug|Dexamethasone|Given IV
15951493|NCT03252600|Biological|Elotuzumab|Given IV
15951494|NCT03252600|Other|Laboratory Biomarker Analysis|Correlative studies
15951495|NCT03252600|Drug|Lenalidomide|Given PO
15951496|NCT03252600|Other|Pharmacological Study|Correlative studies
15951497|NCT03252587|Drug|BMS-986165|Specified dose on specified days
15951498|NCT03252587|Other|Placebo|Specified dose on specified days
15951499|NCT03252574|Other|A|AIR+ Smart Mask Only
15951500|NCT03252574|Other|B|AIR+ Smart Mask with micro-ventilator
15951501|NCT03252561|Procedure|Ultrasound guided Transversus Abdominis Plane (TAP) bock|Ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
15951502|NCT03252561|Procedure|Local anaesthetic infiltration of laparoscopic port sites|Laparoscopic port sites will be infiltrated with a total of 20 mls 0.5% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
15951503|NCT03252535|Biological|Cellavita HD lower dose|The participants will receive a total of 9 intravenous administrations of 1x10^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
15951504|NCT03252535|Biological|Cellavita HD higher dose|The participants will receive a total of 9 intravenous administrations of 2x10^6 cells/weight range divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
15951505|NCT03252535|Other|Placebo|The participants will receive a total of 9 intravenous administrations of placebo divided into three administrations per cycle. Each administration will occur every 30 days and cycles every 120 days (total of 3 cycles).
15951506|NCT03252522|Combination Product|Broad Spectrum Micronutrients|60% of participants will take 3-4 capsules of broad spectrum micronutrients three times per day for eight weeks. Following the initial 8 weeks (of the RCT), all participants will have the option to participate in an open label extension, during which time the child would take the active micronutrient treatment for 8 weeks
15951507|NCT03252522|Dietary Supplement|Placebo|40% of participants will take 3-4 capsules of inactive placebo three times per day for eight weeks.
15951508|NCT03252509|Procedure|Percutaneous radiologic gastrostomy|Percutaneous radiologic gastrostomy: Under conscious sedation and local analgesia, the ultrasound is performed to determine abdominal structures. The stomach is distended using room air through a nasogastric catheter or a 5 French (Fr) catheter. Gastropexy is performed under fluoroscopic guidance. The stomach is accessed using a 18 gauge (G) needle. Guidewire is advanced to the stomach. Progressive tract dilatations until the size of the gastrostomy tube is achieved. The catheter is advanced through the peel-away sheath. The catheter's balloon is inflated with 10ml of distilled water. Iodine contrast is injected to confirm position. After the procedure, the patient is observed for 3 hours. If there are no complications, the patient is discharged.
15951509|NCT03252496|Procedure|Spinal Anesthesia|Performed at the L3-L4 or L4-L5 interspace using 27- or 25-gauge spinal needle
15951510|NCT03252496|Drug|Intrathecal Bupivacaine|Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space
15951511|NCT03252496|Drug|Intrathecal Fentanyl|Fentanyl 15 μg will be administered in the subarachnoid space
15951512|NCT03252496|Procedure|Cesarean Delivery|Lower segment cesarean section using the Pfannenstiel incision
15951516|NCT03252496|Drug|500 mL Crystalloid over 55 minutes|Ringer acetate 500 mL will be administered over 55 minutes following colloid or crystalloid administration
15951791|NCT03250338|Drug|Fludarabine|FLAG-Ida regimen
15951517|NCT03252496|Drug|250 mL Colloid over 60 minutes|After 60 minutes of intrathecal injection, 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 250 mL will be administered over 60 minutes
15951518|NCT03252496|Drug|250 mL Crystalloid over 60 minutes|After 60 minutes of intrathecal injection, Ringer acetate 250 mL will be administered over 60 minutes
15951519|NCT03252496|Drug|Intravenous Ephedrine|Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 120, 110, and 90 mmHg, respectively.
15951520|NCT03252496|Drug|Intravenous Syntocinon|Immediately after delivery, syntocinon 10 IU will be added to the running crystalloid solution
15951521|NCT03252483|Other|Bundled HCV/HIV Screening|Participants were randomized to a bundled HIV/HCV test group (intervention) to evaluate whether integrating HIV and HCV rapid screening would adversely impact HIV test acceptance.
15951522|NCT03252483|Other|HIV Screening|Participants were randomized to an HIV-only screening group as a control comparator.
15951523|NCT03252470|Procedure|Laparoscopic Roux-en-y Gastric Bypass Surgery|Laparoscopic Roux-en-y Gastric Bypass Surgery
15951524|NCT03252457|Drug|Decitabine|given intravenously at a dose of 3.5mg/m2/d for 4 consecutive days as a cycle and repeated every 2 weeks for 3cycles
15951525|NCT03252457|Drug|Dexamethasone|given 40mg/d for 4 consecutive days as a cycle , If platelet count remained below 30 × 109/L or there were bleeding symptoms by day 10, an additional cycle of dexamethasone was given.
15951526|NCT03252444|Other|Conscious control|Conscious control of the scapula is important and can correct neuromuscular coordination as well as strength deficits. The strategy in learning control of scapula into normal orientation can be facilitated by manual guides and/or external cues
15951527|NCT03252444|Other|Conscious control+biofeedback|In electromyography (EMG) biofeedback training, electronic equipment is used to reveal instantaneously certain physiological events.
15951528|NCT03252431|Drug|F-627|single dose pre-filled syringe
15951529|NCT03252431|Drug|Neulasta|single dose pre-filled syringe
15951530|NCT03252418|Drug|Ascorbic Acid 500 MG|ascorbic acid is vitamin that can cause gingival depigmentation
15951531|NCT03252418|Device|diode laser|diode laser is soft tissue laser case photothermolysis of melanoctes
15951532|NCT03252405|Device|mask ventilation|before intravenous induction, mask application is made. then intravenous cannulation and induction
15951533|NCT03252405|Device|intravenous cannulation|induction is applied by using intravenous cannulation
15951534|NCT03252379|Procedure|hepaticojejunostomy|"Under general intubation anesthesia, a generous right subcostal incision is performed and could be extended on demand upward to the xiphoid process and/or to the left subcostal area. Thorough dissection and adhesiolysis is performed to reach the CBD and prepare the unaffected proximal part for anastomosis. The Roux jejunal loop is prepared and passed retrocolic to reach the porta hepatis.
~Then, the hepaticojejunostomy is done via end to side anastomosis using interrupted sutures of polyglactin of 3-0 or 4-0 size. The anastomosis is done 10-15 cm away from the free distal end of the Roux jejunum loop to allow anastomosis without tension to the stomach. A biliary stent may be optionally placed according to operative circumstances and is brought out through the anterior abdominal wall."
15951535|NCT03252379|Procedure|modified hepaticojejunostomy with subcutaneous access loop|"In the subcutaneous access loop, the same steps are done for performing roux-en-Y hepaticojejunostomy.
~The closed free end of roux loop is passed through the anterior abdominal wall in the right subcostal area and then fixed to the wall in a subcutaneous position using 3/0 polyglactin sutures. The limb between the hepaticojejunal anastomosis and the subcutaneous fixation should be short and straight.
~Four Ligaclips are used to mark the jejunal loop by clipping the sutures holding the access loop in place."
15951536|NCT03252379|Procedure|modified hepaticojejunostomy with gastric access loop|"In the gastric access loop, the same steps are done for performing roux-en-Y hepaticojejunostomy.The end of the Roux jejunal loop taken up for hepaticojejunostomy is not closed but is anastomosed to the anterior wall of the gastric antrum near the pyloric orifice.
~All the enterogastrostomies and enteroenterostomies were in the form of single-layer continuous sutures of polyglactin of 3-0 size. An intraperitoneal drain was left in the hepatorenal pouch before closing the incision."
15951537|NCT03252366|Device|GELFOAM|"Three line mucoperiosteal pyramidal flap will be reflected in the posterior maxillary edentulous area to expose the lateral wall of the maxilla.
~A diamond bur will be used to make a rectangular osteotomy.
~The membrane will be carefully elevated from the lateral wall and floor of maxillary sinus with simultaneous implant placement.
~Implant stability will be measured by osteal device
~implant will be inserted with gelfoam (absorbable gelatin) for augmentation• The flap will then be copiously irrigated with saline in preparation for closure.
~The flap will then be closed using interrupted 4/0 resorbable sutures."
15951538|NCT03252366|Device|xenograft|"Three line mucoperiosteal pyramidal flap will be reflected in the posterior maxillary edentulous area to expose the lateral wall of the maxilla.
~A diamond bur will be used to make a rectangular osteotomy.
~The membrane will be carefully elevated from the lateral wall and floor of maxillary sinus with simultaneous implant placement.
~Implant stability will be measured by osteal device
~implants will be inserted with xenograft for augmentation.• The flap will then be copiously irrigated with saline in preparation for closure.
~The flap will then be closed using interrupted 4/0 resorbable sutures."
15951539|NCT03252353|Drug|octreotide capsules|octreotide capsules 40 mg/day, 60 mg/day, 80 mg/day (individual dose titration)
15951540|NCT03252353|Drug|Matching placebo|Matching placebo capsules
15951541|NCT03252340|Drug|ADSTEM Inj.|"ADSTEM Inj. 1.0x10^8 mesenchymal stem cells as an intravenous infusion once in Phase I clinical trial.
~ADSTEM Inj. 3.0x10^8 mesenchymal stem cells as an intravenous infusion once in Phase I clinical trial."
15951542|NCT03252327|Other|Multiple Sensory Integrations|breast milk odor, oral expressed breast milk, heartbeat sounds, nonnutritive sucking.
15951543|NCT03252314|Device|Second-generation hydrogel coils|Hydrogel coils 90% by length
15951544|NCT03252301|Device|PMD 200|finger sensor which estimate objectively the pain level
15951545|NCT03252288|Behavioral|Reminders|Text of phone-call based reminders to mobile phones
15951546|NCT03252288|Behavioral|Conditional financial transfers|Full amount paid if visit occurs within 1 week of the scheduled visit; partial amount is paid if visit occurs >1 week but within 4 weeks of the scheduled visit
15951547|NCT03252275|Other|Peer learning|Peer learning plus HBB and ECEB
15951548|NCT03252262|Other|Vitalize 360|A comprehensive geriatric assessment system and wellness coaching program.
15951549|NCT03252249|Other|3 months dual anti-platelet therapy|Patients with acute coronary syndrome will be randomised to 3 months dual anti-platelet therapy.
15951550|NCT03252249|Other|12 months dual anti-platelet therapy|Patients with acute coronary syndrome will be randomised to 12 months dual anti-platelet therapy.
15951551|NCT03252236|Behavioral|Tai Chi|Modified 12-form Yang style Tai Chi.
15951552|NCT03252236|Behavioral|Conventional exercise|Conventional exercises included mobilization, stretching, muscle strengthening, and walking training.
15951553|NCT03252223|Drug|Recombinant Follicle Stimulating Hormone|A modified dose-response study will be done using recombinant FSH (r-FSH), injected sc for 3 days at any one dose. r-FSH will be administered at weight-adjusted doses equivalent to 37.5, 75, and 150 IU based on an average weight of 70 kg, which approximates the weight of the average woman in the United States according to the Centers for Disease Control. Therefore, the actual dose of r-FSH will be 0.53 IU/kg for the 37.5 dose group. Accordingly, r-FSH will be repeated at doses of 1.1 IU/kg and 2.2 IU/kg that are equivalent to 75 and 150 IU for a 70 kg subject. Each FSH stimulation test will be assigned randomly and be separated by an interval of 8 weeks.
15951554|NCT03252210|Procedure|Preoperative Stereoscopic Localization|1.Confirm the nodule's location and measure the distance between the nodule and anatomic landmarks from the CT scan. 2.According to the results of the first step，confirm the needle puncture site of the chest wall. 3.After general anesthesia and Patient positioning are completed, the needle is then inserted via the needle puncture site .
15951555|NCT03252197|Device|UGIJVC with needle guide device|Study subjects assigned to each group were trained in ultrasound guided internal jugular venous cannulation (UGIJVC) in separate spaces. On each session, subjects were educated about UGIJVC for 30 minutes, and the instructor who was in charge of session, consisted of experienced physicians who had 50 or more UGIJVC success experiences without a supervisor in clinical field. The instructors explained the anatomical structure and the principles of UGIJVC and then demonstrated the procedures directly to the subjects using phantom. After that, all subjects were instructed to perform hands on practice for 30 minutes. In case group, the instructor trained subjects using device. On the other hand in control group, UGIVJC was demonstrated as a conventional method of approaching the target vessel while confirming the needle tip on the ultrasound screen in real time without a device.
15951556|NCT03252197|Device|UGIJVC without needle guide device|participants who are tested performance for ultrasound guided cannulation using conventional method.
15951557|NCT03252184|Device|Low level laser therapy - 1|In the phase 1, the low level laser therapy will be performed with the Fluence device (HTM, Brasil) and the probe from the same manufacturer. For the interventions in groups G1, G2 and G3 (photobiomodulation) will be used, respectively, the energy doses of 18J, 36J and 54J. A 658nm wavelength with an output power of 10mW will be used. Group 4 intervention (placebo photobiomodulation) will be performed with the application of the device turned off. Each intervention will be performed in one day, with an interval of two days between each intervention. Photobiomodulation will be performed on the region of the radial and ulnar arteries of the left arm of each individual. The laser probe will be placed in direct contact with the skin.
15951558|NCT03252184|Device|Low level laser therapy - 2|In the phase 2, the low level laser therapy will be performed with the Thor DD2 (London, UK) and the cluster probe from the same manufacturer. For the interventions in groups G1 and G2 (photobiomodulation) will be used, respectively, the energy doses of 30J and 60J. A 810nm wavelength and an output power of 200mW will be used. Group 3 intervention (placebo photobiomodulation) will be performed with the application of the device turned off. Each intervention will be performed in one day, with an interval of two days between each intervention. Photobiomodulation will be performed on the region of the radial and ulnar arteries of the left arm of each individual. The laser probe will be placed in direct contact with the skin.
15951559|NCT03252184|Device|Low level laser therapy - 3|In the phase 3, the low level laser therapy will be performed with the Thor DD2 (London, UK) and the cluster probe from the same manufacturer. For the interventions in groups G1 and G2 (photobiomodulation) will be used, respectively, the energy doses of 30J and 60J. A 810nm wavelength and an output power of 200mW will be used. Each intervention will be performed in one day, with an interval of two days between each intervention. Photobiomodulation will be performed on the region of the radial and ulnar arteries of the left arm of each individual. The laser probe will be placed in direct contact with the skin.
15951560|NCT03252171|Biological|CAR-T cell immunotherapy|This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at GD2 antigen.
15951561|NCT03252158|Behavioral|Availability of healthier vs. less healthy foods|"Altering the number of slots containing (a) healthier and (b) less healthy foods or beverages in hospital vending machines.
~Changes follow a 2-step process whereby decreases are implemented in a separate study period prior to increases in the contrasting group. Following a 4-week baseline period, all vending machines will be standardised to have 75% healthier drinks and/or 25% healthier snacks (study period 1). Vending machines will be randomly allocated to the order in which they: (1) decrease less healthy foods and increase healthier foods or (2) decrease healthier foods and increase less healthy foods (study periods 2&3 and 5&6). After each decrease-increase pair, machines will return to the standardised 75% healthier drinks / 25% healthier snacks (study periods 4 and 7)."
15951562|NCT03252145|Device|PhysioTouch|The PhysioTouch is a hand-held device that administers negative pressure under the treatment head, and gently pulls the underlying skin and subcutaneous tissue into the suction cup. This suction produces a stretch to the skin and in the subcutaneous tissue space. This action is thought to facilitate lymphatic flow from the interstitium into the lymphatic vessels, and mobilizes the superficial fascia.
15951563|NCT03252145|Other|Manual Lymph Drainage (MLD)|MLD is a practitioner-applied manual massage technique designed to decrease limb volume in patients with lymphedema by enhancing movement of lymph fluid, resulting in reductions in interstitial fluid.
15951564|NCT03252132|Other|12-week resistance training|Training will consist of a minimum of 5 supervised training sessions every 2 weeks and each session will be approximately 60 minutes in duration. Patients will be performing resistance training consisting of at least 3 exercises affecting the largest muscle groups of the body, training the most basic movement patterns that work the entire body as a coordinated system. Patients will train according to a linear progressive model with a slow increase in weight every training session focusing on the flexors, extensors of the ankle and knee and on flexors, extensors and abductors of the hip.
15951565|NCT03252119|Device|High flow humidified oxygen therapy|application of high flow humidified oxygen therapy at 2l/kg/min
15951792|NCT03250338|Drug|Idarubicin|FLAG-Ida regimen
15951566|NCT03252106|Procedure|Contour augmentation with implant placement|Contour augmentation with implant placement
15951567|NCT03252093|Drug|Angiotensin-(1-7)|Subcutaneous injection of 200 mcg/kg/day
15951568|NCT03252093|Drug|Placebo for Angiotensin-(1-7)|Subcutaneous injection of Placebo
15951569|NCT03252080|Behavioral|short-term intensive education|The patients of both groups are given the education classes once a week in the first month (total 4 times), 5 hours per class. The education classes are taught by a dedicated team of diabetes specialist doctors and nurses, with the contents including a basic understanding of diabetes, diabetic diet, exercise, drug treatments and blood glucose monitoring.
15951570|NCT03252080|Behavioral|Holistic management|The specialist nurses talk individually with the patients for 10-15 min per week. The nurses ask the patients about their results of self-blood glucose monitoring, help them find the reasons of poor blood glucose control as well as answer the patient's questions.
15951571|NCT03252067|Drug|azithromycin eyedrop|Tear samples will be collected using the strips.
15951572|NCT03252054|Diagnostic Test|Screening for memory disorders, attention disorders, and malnutrition|Screening for memory disorders, attention disorders, and malnutrition, using Six-Item Screener, Months of the Year Backwards Test, and NRS-2002 and MNA-SF, respectively.
15951573|NCT03252041|Device|MRI|Magnetic Resonance imaging modalities and sequences in pelvic congestion syndrome
15951574|NCT03252015|Drug|Probe Drug Cocktail|Administered orally
15951575|NCT03252015|Drug|Lasmiditan|Administered orally
15951576|NCT03252015|Drug|Placebo|Administered orally
15951577|NCT03252002|Drug|BAY1101042|Single oral dose of 10 mg, 20 mg, 30 mg, 40 mg, 50 mg or optionally 5 mg BAY 1101042 (given as 5 mg MR tablets) or corresponding placebo followed by once daily dosing for 7 days
15951578|NCT03252002|Drug|Placebo|Single dose on Day 1 (00d) and once daily for 7 days from Day 3 (02d) until Day 9 (08d)
15951579|NCT03251976|Behavioral|video|informational video
15951580|NCT03251976|Behavioral|usual care|usual physician counseling on end of life care
15951581|NCT03251963|Drug|Fixed Dose Enoxaparin|Eligible patients will be administered 40 mg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.
15951582|NCT03251963|Drug|Variable Dose Enoxaparin|Eligible patients will be administered 0.5 mg/kg enoxaparin daily and will have steady state peak and trough anti-Xa levels drawn after the third enoxaparin dose. For patients in-range (levels 0.3-0.5IUmL), no intervention will be undertaken. For patients out of range, enoxaparin dose will be adjusted according to an established dose adjustment algorithm. Repeat levels will be checked after the third administration of the new dose.
15951583|NCT03251950|Behavioral|healthy eating and gardening|15 week healthy eating and gardening intervention for children aged 3-5 years; 15 week online parenting intervention to promote healthy eating; Menu change in early childhood center to promote healthy eating
15951584|NCT03251937|Device|Spectra WaveWriter SCS System|Multiple modalities of stimulation therapy
15951585|NCT03251924|Drug|BMS-986226|specified dose on specified days
15951586|NCT03251924|Biological|Nivolumab|specified dose on specified days
15951587|NCT03251924|Biological|Ipilimumab|specified dose on specified days
15951588|NCT03251924|Biological|Tetanus Vaccine|specified dose on specified days
15951589|NCT03251911|Drug|Ivacaftor (VX-770)|of Ivacaftor (VX-770) for the Treatment of Chronic Bronchitis with CFTR Dysfunction
15951590|NCT03251885|Other|swabs|Two swabs will be taken at each screen: one from the vagina and the other from the rectum for vaginal and rectal assessment of maternal colonization
15951591|NCT03251872|Drug|Olaparib|Olaparib tablets
15951592|NCT03251859|Drug|Ticagrelor 90 mg|Ticagrelor 90 mg twice daily
15951593|NCT03251859|Drug|Ticagrelor 60 mg|Ticagrelor 60 mg daily
15951594|NCT03251846|Device|Pops! One personalized mobile platform|Enrolled subjects will be given a POPS! Device (meter, lancet/test strips, and software app) to use for 6 months. Primary outcomes will be measured at baseline and 6-month follow-up.
15951595|NCT03251820|Drug|corticosteroid|Each patient will be subjected to a one month course of steroids and then re-evaluated
15951596|NCT03251807|Device|Twin-block|Functional treatment will be achieved using the Twinblock appliance
15951597|NCT03251807|Other|LIPUS (Low-intensity pulsed ultrasound)|Functional treatment will be combined with LIPUS (Low-intensity pulsed ultrasound )
15951598|NCT03251794|Diagnostic Test|three dimensional ultrasound|evaluation of the suprarenal glands
15951599|NCT03251794|Diagnostic Test|color Doppler|Doppler evaluation of the suprarenal artery
15951600|NCT03251781|Other|Pulmonary Rehabilitation|Pulmonary rehabilitation program (PRP) was conducted according to the guidelines of the American Thoracic Society/European Respiratory Society (Nici et al., 2006; Spruit et al., 2013). Physical training was conducted over 24 sessions supervised, three times a week. The program included aerobic training in treadmill (with 30 min load determined by the dyspnea sensation - 4 to 6 on the modified Borg scale) and localized training for upper limbs with free weights or elastic bands (movements performed based on the proprioceptive neuromuscular facilitation diagonals, performed in two series, lasting two minutes each) and lower limbs (quadriceps and triceps sural) with free weights and/or in the bodybuilding station.
15951601|NCT03251768|Drug|rHSA-GCSF 2.4mg|Human Serum Albumin GCSF 2.4mg at day 3 and day 7
15951602|NCT03251768|Drug|GCSF|GCSF 5 mcg/kg/day
15951603|NCT03251755|Behavioral|Yoga|Exercise promotion using Chinese Yoga
15951604|NCT03251742|Device|Hayek RTX ventilator|Negative pressure ventilation in Fontan patients.
15951605|NCT03251729|Procedure|Cervical cerclage|Transvaginal cervical cerclage placed between 18 0/7 - 23 6/7 weeks
15951606|NCT03251729|Drug|Vaginal progesterone|Vaginal progesterone 200mg suppository or 90mg gel nightly from randomization until 36 weeks
15951607|NCT03251716|Drug|berberine|berberine 300mg TID add-on for berberine adjunctive group
15951641|NCT03251469|Drug|Normal Saline, 100mg, iv, Singe dose|Normal Saline, 100mg, administered intravenously, preoperatively in single dose
15951751|NCT03250585|Diagnostic Test|Exhaled Breath Condensate (EBC)|Serial EBC samples will be collected within 48 hours of acute chest syndrome (ACS) diagnosis and at 2 week follow up
15951608|NCT03251703|Procedure|Ultrasound-Guided Suprascapular Pulsed Radiofrequency .|The ultrasound-Guided Suprascapular Pulsed Radiofrequency was administered under operating room conditions while the patient was monitored in a sitting position.An ultrasound-guided 22 G 5-mm active-tip 100-mm radiofrequency needle (SC-K; Top Neuropole, Tokyo, Japan) was pushed forward towards the suprascapular notch until it passed the transverse scapular ligament using an in-plane approach.
15951609|NCT03251690|Drug|Tenofovir/Emtricitabine/Rilpivirine|Tenofovir/Emtricitabine/Rilpivirine to compare the non-inferiority of efficacy and adverse effects to Tenofovir/Emtricitabine/Efavirenz in patients with virological suppression
15951610|NCT03251690|Drug|Tenofovir/Emtricitabine/Efavirenz|as a active comparator
15951611|NCT03251677|Procedure|Surgical procedure, Hysterectomy|Surgical removal of the uterus
15951612|NCT03251664|Dietary Supplement|Food groups consumed|
15951613|NCT03251651|Drug|Propofol|Propofol is infused continuously via the target-controlled infusion device (Orchestra®, Fresenius vial, Brezins, France), and the effect-site concentration is maintained within 0.5-2.0 μg/ml.
15951614|NCT03251651|Drug|Dexmedetomidine|Dexmedetomidine is diluted with 0.9% saline to make a concentration of 4 μg/ml. As a loading dose, 1 μg/kg dexmedetomidine is administered over a 10-min period, which is then administered continuously at 0.1-0.5 μg/kg/h.
15951615|NCT03251625|Drug|Probiotic Formula Capsule|
15951616|NCT03251612|Drug|Based on sensitivity analysis|"5FU, infusional
~Capecitabine
~Oxaliplatin (FOLFOX)
~Irinotecan (FOLFIRI)
~FOLFOXIRI (triplet)
~Bevacizumab
~Panitumumab
~Cetuximab
~Regorafenib
~Tas-102
~Ramucirumab
~Aflibercept
~Pembrolizumab
~Nivolumab
~Vinorelbine and capecitabine
~Sorafenib
~Gemcitabine and capecitabine
~Olaparib
~Epirubicin"
15951617|NCT03251599|Drug|Glyceryl trinitrate 0.2|These patients will receive glyceryl trinitrate infusion at a rate of 0.2 mcg/kg/min throughout the rewarming period of cardiopulmonary bypass, which usually lasts for 30-45 minutes.
15951618|NCT03251599|Drug|Glyceryl trinitrate 0.5|These patients will receive glyceryl trinitrate infusion at a rate of 0.5 mcg/kg/min throughout the rewarming period of cardiopulmonary bypass, which usually lasts for 30-45 minutes.
15951619|NCT03251586|Diagnostic Test|oVEMP - infra-orbital electrode montage|oVEMPs are short latency (~10 ms) stimulus-synchronized extra-ocular muscle reflexes produced in response to appropriate stimuli. The response is believed to originate from excitation of the utricular macula with the subsequent neural response relayed to the brain by the superior portion of the vestibular nerve. Changes in the electrical field of the contralateral inferior oblique muscle can be recorded by an electrode placed at the infra-ocular midline of the lower lid while having the subject gaze upward. The conventional electrode montage, the infra-orbital electrode montage, has the active electrode placed directly inferior to the eye and the reference electrode placed 2-3 cm below the active on the cheek. This electrode montage may result in reference contamination, which will cause an artificially reduced amplitude response, as a portion of the response can be measured by the reference electrode.
15951620|NCT03251586|Diagnostic Test|oVEMP - belly-tendon electrode montage|oVEMPs are short latency (~10 ms) stimulus-synchronized extra-ocular muscle reflexes produced in response to appropriate stimuli. The response is believed to originate from excitation of the utricular macula with the subsequent neural response relayed to the brain by the superior portion of the vestibular nerve. Changes in the electrical field of the contralateral inferior oblique muscle can be recorded by an electrode placed at the infra-ocular midline of the lower lid while having the subject gaze upward. The belly-tendon electrode montage consists of an active electrode placed laterally to the midline of the lower eyelid and a reference electrode placed on the inner canthus. This reference location is believed to be electrically neutral, and should therefore result in larger amplitude responses as the response would not be subject to reference contamination.
15951621|NCT03251573|Other|cognitive impairment|one are of patients were exposed to cognitive impairment
15951622|NCT03251560|Drug|Fuke Qianjin capsule|Fuke Qianjin capsule 0.8g pills by mouth, three times daily
15951623|NCT03251560|Drug|Placebo oral capsule|Placebo oral capsule 0.8g pill by mouth, three times daily
15951624|NCT03251547|Drug|NovoSeven|To survey retrospectively the treatment indications, clinical outcome, transfusion need and changes in coagulation profiles of non-haemophiliac patients who had received rFVIIa during massive bleeding
15951625|NCT03251534|Procedure|Centromedullary nailing|
15951626|NCT03251521|Other|pain rating during injection with botulinum toxin|The pain intensity was rated verbally on a numeric scale. The pain was rated after each phase of injection
15951627|NCT03251508|Drug|Peanut OIT|Participants will be given increasing doses of the peanut flour as peanut oral immunotherapy (OIT) with increasing doses every 2 weeks over a period of 3 months up to a 300 mg target dose. This 300 mg peanut OIT maintenance dose is then continued daily for 3 months. Participants will then introduce dietary peanut of approximately 300 mg of peanut protein and continue daily ingestion for an additional 6 months.
15951628|NCT03251495|Drug|Vaxchora|Vaxchora is a live attenuated cholera vaccine that provides immunity against V. cholerae serogroup O1. Participants will receive one single oral dose of 100 mL.
15951629|NCT03251482|Drug|JNJ-64179375 0.3 mg/kg|JNJ-64179375 0.3 milligram per kilogram (mg/kg) intravenous (IV) infusion as a single dose on Day 1.
15951630|NCT03251482|Drug|JNJ-64179375 0.6 mg/kg|JNJ-64179375 0.6 mg/kg IV infusion as a single dose on Day 1.
15951631|NCT03251482|Drug|JNJ-64179375 1.2 mg/kg|JNJ-64179375 1.2 mg/kg IV infusion as a single dose on Day 1.
15951632|NCT03251482|Drug|JNJ-64179375 (Dose to be Determined)|JNJ-64179375 IV infusion (Dose to be determined) as a single dose on Day 1.
15951633|NCT03251482|Drug|JNJ-64179375 A mg/kg|JNJ-64179375 Dose A mg/kg IV as a single dose on Day 1.
15951634|NCT03251482|Drug|JNJ-64179375 B mg/kg|JNJ-64179375 Dose B mg/kg IV as a single dose on Day 1.
15951635|NCT03251482|Drug|JNJ-64179375 C mg/kg|JNJ-64179375 Dose C mg/kg IV as a single dose on Day 1.
15951636|NCT03251482|Drug|JNJ-64179375 D mg/kg|JNJ-64179375 Dose D mg/kg IV as a single dose on Day 1.
15951637|NCT03251482|Drug|Placebo JNJ-64179375|Matching JNJ-64179375 placebo (normal saline) administered as IV infusion as a single dose on Day 1.
15951638|NCT03251482|Drug|Apixaban placebo|Matching apixaban placebo administered orally twice a day for 10 to 14 days.
15951639|NCT03251482|Drug|Apixaban 2.5 mg|Apixaban 2.5 mg administered orally twice a day for 10 to 14 days.
15951640|NCT03251469|Drug|Tranexamic Acid 15mg/kg , iv, Single Dose|Tranexamic Acid 15mg/kg , administered intravenously, preoperatively, in a single dose
15951642|NCT03251456|Other|Tertiary care|"Inform the parents that there are abnormalities after eye disease screening of their children, and the program of tertiary care for visual developmental disorders
~The children will be receiving the appropriate therapy in tertiary care and follow-up according to the clinical guidelines
~Six months after receiving the screening report, all the parents will be interviewed by telephone, or visiting if necessary."
15951643|NCT03251456|Other|Usual Care|"Inform the parents that there are abnormalities after eye disease screening of their children
~Inform the parents that they should take their children to the hospital for further consultation
~Six months after the receiving the screening report, all the parents will be interviewed by telephone, or visiting if necessary."
15951644|NCT03251443|Drug|Apatinib|500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops.
15951645|NCT03251430|Procedure|gastrectomy|Distal gastrectomy, Total gastrectomy
15951646|NCT03251417|Drug|Irinotecan|Irinotecan 150mg/m2, repeated very 2 weeks for 3 to 6 cycles.
15951647|NCT03251417|Drug|Apatinib|Apatinib 500 mg oral take, daily
15951648|NCT03251404|Other|Injury prevention exercise programs|The two intervention programs contain exercises aiming to increase lower extremity strength, core stability, balance and neuromuscular function.
15951649|NCT03251391|Other|Cardiac Rehabilitation Program|"Program will involve 36 sessions. These will be scheduled as 3 sessions per week. If you cannot complete 3 sessions per week the 36 sessions could be spread out over 6 months.
~Each session will last between 30-60 minutes. Sessions will involve aerobic activity, diet/nutritional counseling, and smoking cessation information."
15951650|NCT03251391|Other|Conventional Therapy|Participants will be asked to complete tests and questionnaires that would normally be done for their condition.
15951651|NCT03251378|Drug|Fruquintinib (HMPL-013)|Fruquintinib is a small molecule tyrosine kinase inhibitor (TKI) that targets VEGFR-1, -2, and -3, with a novel chemical structure which belongs to the quinazoline class.
15951652|NCT03251365|Drug|HIPEC-gemcitabine|• Group II.After a R0 cytoreductive surgery, HIPEC is performed with gemcitabine, 120mg / m2 for 30' + adjuvant treatment with iv gemcitabine , 1000 mg / m2 for at least 4 cycles
15951653|NCT03251339|Drug|MSB11455|Participants received a single subcutaneous injection of MSB11455 6 milligram (mg) per (/) 0.6 milliliter (mL) on Day 1 in morning of treatment period 1 (28 Days) and 2 (28 Days). Period 1 and Period 2 are separated by a washout period of 35 Days.
15951654|NCT03251339|Drug|US-Neulasta|Participants received a single subcutaneous injection of US-Neulasta 6 mg/0.6 mL on Day 1 in morning of treatment period 1 and 2. Period 1 and Period 2 are separated by a washout period of 35 Days.
15951655|NCT03251326|Drug|Nabilone|Nabilone capsules (4 mg)
15951656|NCT03251326|Drug|Cannabis|Cigarettes (0.0 and 5.6% THC)
15951657|NCT03251326|Drug|Propranolol|Propranolol capsules (40mg)
15951658|NCT03251326|Drug|Placebo|Placebo capsules
15951659|NCT03251313|Combination Product|JS001 120mg+GP|In this arm, JS001 120mg will be given at d1; Gem 1000mg/m2 d2,9; DDP(cisplatin) 75mg/m2 d2
15951660|NCT03251313|Combination Product|JS001 240mg+GP|In this arm, JS001 240mg will be given at d1; Gem 1000mg/m2 d2,9; DDP 75mg/m2 d2
15951661|NCT03251313|Combination Product|JS001 480mg+GP|In this arm, JS001 480mg will be given at d1; Gem 1000mg/m2 d2,9; DDP 75mg/m2 d2
15951662|NCT03251313|Combination Product|GP followed by JS001|In this arm,Patients receive 6 cycles of GP without JS001 and then receive JS001 maintenance therapy for up to approximately 2 years. JS001 will be given at RP2D.
15951663|NCT03251300|Drug|daytime dosing of mirabegron|All OAB female patients will receive daytime dosing (08:00 AM) of mirabegron
15951664|NCT03251300|Drug|nighttime dosing of mirabegron|All OAB female patients will receive nighttime dosing (08:00 PM) of mirabegron
15951665|NCT03251287|Drug|Sodium Nitrate|Single dose of 14mmol oral inorganic sodium nitrate
15951666|NCT03251287|Drug|Placebo|Single dose of oral matching placebo
15951667|NCT03251287|Diagnostic Test|Phosphorous Magnetic Resonance Spectroscopy|On the first visit day of this arm, participants will be lie inside an MRI scanner to take pictures of the heart. The thigh muscle will then be imaged before, during, and after kicking exercises.
15951668|NCT03251287|Diagnostic Test|Exercise Stress Transthoracic Echocardiogram|On the second visit day of this arm, participants will be asked to lie, semi-erect, on an exercise bed for up to 90 minutes. The echocardiogram will be performed at rest and during peak exercise. The exercise will be in the form of a pedal bike. The exercise levels will be worked out from an upright bicycle exercise test completed by the participants prior to randomization.
15951669|NCT03251274|Other|machine bathing|machine bathing 20-min duration at evening
15951670|NCT03251274|Other|traditional bathing|traditional bathing
15951671|NCT03251261|Device|illumigene CMV assay, illumipro-10|CMV assay for detection of CMV
15951672|NCT03251248|Drug|MSB11455|Subjects will receive MSB11455 either on Period 1 Day 1 or Period 2 Day 1.
15951673|NCT03251248|Drug|Neulasta|Subjects will receive Neulasta either on Period 1 Day 1 or Period 2 Day 1.
15951674|NCT03251235|Behavioral|Cognitive Behaviour Therapy|
15951675|NCT03251222|Drug|Dexmedetomidine|Intranasal aplication of dexmedetomidine
15951676|NCT03251222|Other|Placebo - Concentrate|Intranasal aplication of 0.9% NaCl
15951677|NCT03251209|Other|Physical practice|Physical Practice: reproduce through the motor execution (4 distinct tasks: stacking cubes, opposition of fingers with precision gripping, passing water from one glass to another, sequencing of bottles), the activities assisted in the video (5 minutes / task).
15951678|NCT03251209|Other|Mental practice|Mental practice: think about the tasks watched in the videotherapy (4 distinct tasks: stacking cubes, opposition of fingers with precision gripping, passing water from one glass to another, sequencing of bottles) for 5 minutes / task.
15951679|NCT03251209|Other|Videotherapy|Videotherapy, being 2 minutes per task (4 distinct tasks: stacking cubes, opposition of fingers with precision gripping, passing water from one glass to another, sequencing of bottles)
15951680|NCT03251196|Other|No Intervention, and Observational Study|Observational Study
15951714|NCT03250910|Drug|Sofosbuvir and Velpatasvir|All patients received a generic version of VEL/SOF fixed-dose combination (Sofosvel®, VEL/SOF 100/400 mg film coated tablet, Beacon Pharmaceuticals Ltd. Mymensingh, Bangladesh) 1 tablet per day for 12 weeks.
15951752|NCT03250585|Diagnostic Test|Plasma Sample|Serial plasma samples will be collected within 48 hours of acute chest syndrome (ACS) diagnosis and at 2 week follow up
15951681|NCT03251183|Diagnostic Test|Comprehensive Cardiovascular magnetic resonance (CMR)|Cardiovascular magnetic resonance (CMR) provides non-invasive, radiation-free and in-depth evaluation of myocardial structure and function. In addition to established tools for assessment of cardiac volume, mass, function and regional myocardial scar with late Gadolinium enhancement (LGE), several novel quantitative CMR parameters will be assessed including T1-mapping or fully quantitative perfusion Imaging.
15951682|NCT03251183|Diagnostic Test|Blood sampling|Blood samples will eventually be analysed for markers related to heart failure (BNP/NT)-pro-BNP, myocardial inflammation and fibrosis (cytokine profiling, Galectin-3, Procollagen Type I and III, hsCRP). Whole blood will be frozen for DNA isolation and genome analysis. Peripheral blood mononuclear cells will be isolated by Ficoll in a subset of patients and will be used for RNA isolation allowing RNA-seq or reverse transcription (RT) - polymerase chain reaction (PCR) analysis.
15951683|NCT03251183|Diagnostic Test|TTE (EchoErgo)|Measurements will include cavity dimensions, flow velocities, myocardial motion velocity and strain as well as for change of parameters during ergometric stress.
15951684|NCT03251183|Diagnostic Test|Invasive pressure-volume (PV) Loops|Multiple parameters (including EDPVR, ESPVR, dp/dt min, Tau, Ea) will be derived from the various PV loop assessments and additional relevant parameters will be calculated. Right ventricular and pulmonary pressures including pulmonary vascular resistance will be measured with Swan-Ganz catheters using right venous femoral approach.
15951685|NCT03251183|Diagnostic Test|Left ventricular (LV) biopsy|"A set of myocardial biopsies for each patient will be stained with Masson Trichrome for qualitative and quantitative assessment of the collagen volume fraction; fat droplets will be identified by red oil staining, Congo Red for amyloid immunohistology will be used to determine total leukocytes (CD45), T-cells (CD3) and monocytes/macrophages (CD68).
~A second set of biopsies will be frozen immediately and stored at -80°. Western blot analysis will be performed to determine alterations at the myofilament level including titin isoform composition and phosphorylation status."
15951686|NCT03251170|Drug|Ketamine|Patients will receive :1 mg/Kg ketamine for induction of anesthesia
15951687|NCT03251170|Drug|Fentanyl|Patients will receive :2.5 mcg/Kg fentanyl for induction of anesthesia
15951688|NCT03251170|Drug|Midazolam|Patients will receive 0.05 mg/Kg midazolam
15951689|NCT03251157|Other|Dietary intake of various nutrients, foods and biocompounds|Participants answered a self-administered FFQ, in which they reported the usual frequency of intake of a list of 250 food items
15951690|NCT03251144|Drug|Switch to E/C/FTC/TAF daily|"If the participant is on an antiretroviral regimen other than Elvitegravir (ELV)/cobicistat CO)/emtricitabine (FTC)/tenofovir (TDF)] (E/C/FTC/TDF) then the participant will be asked to switch to E/C/FTC/TDF for up to 6 months. This will allow for future switch (after these 6 months) from E/C/FTC/TDF 1 tablet once daily to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/FTC/TAF) 1 tablet once daily for a period of 12 months.
~b) If the participant is on E/C/FTC/TDF 1 tablet once daily then the participant will be asked to switch from /C/FTC/TDF 1 tablet once daily to /C/FTC/TAF 1 tablet once daily for a period of 12 months."
15951691|NCT03251131|Other|Restrictive fluid management|Daily fluid input is restricted to drugs and nutrition. Fluid boluses and blood products can be given if clinically indicated. Matching fluid output to fluid input whenever possible using diuretics if needed, and additionally, if clinically necessary and plausible, commencing renal replacement therapy. If renal replacement therapy is not deemed clinically desirable, acceptance of a less than targeted fluid balance.
15951692|NCT03251105|Device|supraglottic airway intubation|
15951693|NCT03251092|Drug|PTI-808|Active
15951694|NCT03251092|Drug|Placebo|Placebo
15951695|NCT03251092|Drug|PTI-428|Active
15951696|NCT03251092|Drug|PTI-801|Active
15951697|NCT03251066|Other|Proponent Nasal Spray|The medical device consists of a Saline solution containing sodium propionate which is administered as single dose
15951698|NCT03251053|Device|Electronic cigarette use|Replacement of tobacco smoking with electronic cigarette vaping
15951699|NCT03251053|Other|Control regular cigarette smokers|
15951700|NCT03251040|Device|Autologous activated fibrin sealant|Application of fibrin sealant
15951701|NCT03251027|Radiation|Intensity-Modulated Radiation Therapy|Undergo IM-SRT
15951702|NCT03251027|Other|Quality-of-Life|Ancillary studies
15951703|NCT03251014|Other|YSS|Intervention providing steamed whole YSS (~265 g/day, 3 days/week) for eight weeks
15951704|NCT03251014|Other|Salmon|Intervention providing steamed salmon fillet (~246 g/day, 3 days/week) for eight weeks
15951705|NCT03251001|Procedure|Control|Free epithelized gingival graft, harvested from palate, was grafted in a site with lack of keratinized gingiva
15951706|NCT03251001|Device|Acellular Dermal Matrix|Acellular Dermal Matrix was grafted in a site with lack of keratinized gingiva, in substitution of an autogenous graft from patient palate
15951707|NCT03250988|Diagnostic Test|Neurological Examination|The subject will undergo elements of the neurological examination during which the movement disorders neurologist will look specifically for the presence of spasticity. If spasticity is found to be present during the examination, the neurologist will rate the severity of the spasticity in all affected limbs and record whether they would recommend treatment for spasticity, and if so, which treatment(s) they believe would be beneficial for the subject.
15951710|NCT03250962|Drug|SHR-1210|SHR-1210 is a humanized anti-PD-1 monoclonal antibody.
15951711|NCT03250962|Drug|Decitabine|Decitabine is an investigational (experimental) drug that works by depleting DNA methyltransferase 1 (DNMT1), which can increase tumor antigens and HLA expression, enhances antigen processing, promotes T cell infiltration, and boosts effector T cell function.
15951712|NCT03250949|Procedure|implant site over drilling protocol|"Osteotomy preparations for the loose fit group will be identical to those of the tight fit group until final drill, which will be 0.2mm wider than the diameter of the implant.
~osteotomy site of the implant is wider by 0.2mm than the implant diameter"
15951713|NCT03250923|Drug|silver citrate complex and acemannan|Oral rinse solution with each dose containing 100μg silver citrate complex and 40mg acemannan
15951715|NCT03250910|Drug|Ribavirin|Patients with decompensated cirrhosis (Child-Pugh B or C), received weight-based ribavirin (RBV)(Robatrol®, 200 mg capsule, Genovate Biotechnology Co. Ltd., Hsinchu, Taiwan; 1,200 mg per day if the body weight ≥ 75 kg; 1,000 mg per day if the body weight < 75 mg) for 12 weeks.
15951716|NCT03250871|Other|Hypnosis|Hypnosis will be supervised by a nurse trained by the French Institute of Hypnosis.
15951717|NCT03250871|Other|Placebo|Placebo consists in non-hypnotic relaxation suggestions and in hearing white noise through headphones
15951718|NCT03250858|Behavioral|Personalised advice|Provision of online personalised advice on dietary intake, weight and physical activity levels. Personalised recommendations for improved food choice based on adherence to an 11-item modified US Alternative Healthy Eating Index (m-AHEI), for weight based on ideal BMI range and for physical activity based on the Baecke questionnaire/results.
15951719|NCT03250858|Behavioral|Non-personalised advice|Provision of online non-personalised advice on dietary intake, weight and physical activity levels. Non-personalized dietary advice for improved food choice based on standard population health guidelines.
15951720|NCT03250832|Drug|TSR-033|TSR-033 is a humanized monoclonal antibody immunoglobulin (Ig) G4.
15951721|NCT03250832|Drug|Dostarlimab|Dostarlimab (previously referred to as TSR-042) is an IgG4 antibody.
15951722|NCT03250832|Drug|mFOLFOX6|mFOLFOX6 is combination of folinic acid (FOL)/leucovorin, 5-fluorouracil and oxaliplatin (OX) which acts as systemic cytotoxic agent.
15951723|NCT03250832|Drug|FOLFIRI|FOLFIRI is combination of folinic acid (FOL)/leucovorin, 5-fluorouracil and irinotecan (IRI) which acts as systemic cytotoxic agent.
15951724|NCT03250832|Drug|Bevacizumab|Bevacizumab is a humanized monoclonal IgG1 antibody that targets vascular endothelial growth factor (VEGF)-A to inhibit angiogenesis.
15951725|NCT03250819|Other|SNP analysis|The collected blood samples will be used to investigate the occurrence of SNPs (single nucleotide polymorphisms) in both study groups
15951726|NCT03250793|Device|Physiologic study measuring work of breathing which can be estimated by the esophageal and trans-diaphragmatic pressure-time product obtained by an esophageal transducer|While the patient is under respiratory assistance on the SERVO-I respirator, he will be included in the study and one esophageal transducer of 2,3 mm of diameter will be inserted through the mouth / nose in addition to NAVA's naso / Oro-Gastric tube( Edi Catheter, 6Fr, 49 cm, PHT free 5 pcs / pkg or Catheter Edi, 6Fr, 50 cm, PHT free 5 pcs / pkg). Measurements will be performed using the esophageal transducer under two conditions: 2 hours in conventional ventilation (pressure controlled), 2 hours in NAVA ventilation and then again 2 hours in conventional ventilation (PC) for a total duration of 6 hours.The parameters of conventional ventilation will be left free at the choice of the neonatologist and will be identical between the two periods of conventional ventilation. The initial NAVA level will be defined by the neonatologist using pre-visualization curves. All signals will be recorded via an amplification and acquisition system. Values will be averaged over 100 cycles.
15951727|NCT03250780|Procedure|indigo-carmine 0.2% using a spray catheter|
15951728|NCT03250780|Procedure|0.03% using a foot pump|
15951729|NCT03250767|Device|Integra Titan Modular Shoulder System 2.5|Primary Shoulder Joint Replacement
15951730|NCT03250754|Device|Electroacupuncture|Needles on the extremities were stimulated by electro-stimulation device applied by a biphasic pulse generator apparatus at a frequency of pulses alternated between 2 Hz and 100 Hz and the maximum tolerable intensity.
15951731|NCT03250741|Drug|Rotigotine transdermal patch|Rotigotine transdermal patches 4mg/24hr
15951732|NCT03250741|Other|Placebo|Placebo transdermal patches of the same size as for Rotigotine transdermal patches
15951733|NCT03250728|Biological|Peripheral blood puncture|"Endothelial progenitor cells will be isolated from peripheral blood by density gradient and cultured in 10%FBS EGM2 medium
~On the EPCs we will study:
~the endothelial permeability
~the protein C system"
15951734|NCT03250715|Other|Low Level Laser Therapy|For application of the LLLT in the quadriceps muscle the patient will be in dorsal decubitus, with the legs extended and will be defined by the palpation of the muscle belts six points of application: two points in the distal region of the vastus medialis muscle, two points of the distal region of the vastus lateral muscle and two points of the central region of the rectus femoris muscle. For the application of LLLT in the gastrocnemius muscle the patient will remain in the supine position, but will be oriented to keep the hips and knees flexed at 90º and 45º respectively. Two application points will be defined, one in the lateral ventricle and the other in the medial ventricle, but both in the distal region of the muscle.
15951735|NCT03250689|Drug|Danirixin|Danirixin will be available as 35 mg oval shaped, white film coated HBr embossed tablets.
15951736|NCT03250689|Drug|Placebo|Placebo will be available as oval shaped, white film coated tablets.
15951737|NCT03250689|Drug|Rescue medication|Subjects may continue to use rescue medication(s) anytime during the study. The following rescue medications may be used: short acting beta agonists, short acting muscarinic antagonists, or short acting combination bronchodilators.
15951738|NCT03250689|Drug|Inhaled COPD maintenance medication|Subjects may continue to use inhaled COPD maintenance medication(s) during the study, at the discretion of the GSK Medical Monitor and/or Investigator. The following maintenance medications may be used: long acting bronchodilator medications (e.g. long-acting muscarinic antagonist [LAMA], long-acting beta-agonist [LABA]) and long-acting bronchodilator combination therapies (e.g. LAMA/LABA) and long-acting bronchodilator/inhaled corticosteroid steroid combination (ICS) therapies (e.g. LABA/ICS, LAMA/LABA/ICS)
15951739|NCT03250676|Drug|H3B-6545|Oral capsules by mouth once daily
15951740|NCT03250663|Behavioral|Online Treatment response|Electronic treatment response survey to track use of study medication, EUCRISA (crisaborole) ointment 2%.
15951741|NCT03250663|Drug|EUCRISA|Participants are given EUCRISA (crisaborole) ointment 2%.
15951742|NCT03250650|Device|TTNS|Transcutaneous tibial electric stimulation
15951743|NCT03250650|Device|ES+TTNS|Transvaginal electric stimulation
15951744|NCT03250637|Other|Observational|Information on diet, lifestyle, weight, height, medical treatment, environmental exposures, and other socio-economic factors were collected at enrolment using questionnaires and interviews
15951745|NCT03250624|Drug|CD 5024 0.3% cream|Up to 4g daily, once a day, 7 days a week for 6 weeks
15951746|NCT03250624|Drug|CD 5024 cream placebo|Up to 4g daily, once a day, 7 days a week for 6 weeks
15951747|NCT03250611|Procedure|Occipital Condyle Screw|Occipito-Cervical Screw-Rod Fixation Technique
15951754|NCT03250559|Procedure|Percutaneous nephrolithotomy|Endoscopic kidney stone extraction technique.
15951755|NCT03250546|Procedure|transplant from a haplo-identical donor|The transplant procedures will be similar in the 2 groups beside the origin of cells
15951756|NCT03250546|Procedure|transplant from a non related donor|The transplant procedures will be similar in the 2 groups beside the origin of cells
15951757|NCT03250533|Device|Light emitting diodes (LED)|The light-emitting diode (LED) device consists of a soft 15 x 15 cm blanket, which allows the body segment curvature of the cutaneous lesion to be monitored. The LEDs are fixed equidistant to obtain uniform irradiation over the entire ulcer. The wound site will be surrounded by a PVC film (polyvinyl chloride), to avoid contamination, for posterior positioning of the LED device, applying light directly and perpendicularly, with energy density of 6 J / cm². All LEDs will be calibrated prior to the start of applications in the Laboratory of Photobiophysics of the Faculty of Sciences and Letters of Ribeirão Preto, University of São Paulo, in which the wavelengths will be checked, the angle of radiation, power and power density.
15951758|NCT03250533|Device|Fixed diphasic current|The electrical stimulation treatment will be performed with the fixed diphasic current of the Dualpex 071 equipment (Quark®, Piracicaba, SP, Brazil), with the monopolar technique, 100 Hz, maximum intensity of 1 mA / cm² of lesion for 10 minutes. Autoclave sterilized aluminum electrodes will be used, one on the lesion (negative pole) and the other transversal to the segment (positive pole). The size of the electrode will be proportional to the extension of the lesion, having as a means of contact between the electrode and the ulcer, sterile gauze moistened with 0.9% saline solution.
15951759|NCT03250520|Drug|Platinum acetylacetonate (1% wt) supported by sol-gel technology functionalized titania|Sol-gel process Pt(acac)2- F-TiO2 nanostructured material with antitumoral activity used as an alternative in the treatment of cancer tumors. The biocatalysts were prepared by the sol-gel route using the complex Pt(acac)2.
15951760|NCT03250507|Drug|Bupivacaine|0.25% bupivacaine for TAP block
15951761|NCT03250507|Drug|Liposomal bupivacaine|Exparel for TAP block
15951762|NCT03250507|Drug|Saline|Saline for TAP block that will be mixed with liposomal bupivacaine to bring the liposomal bupivacaine group to 60 mL total volume.
15951763|NCT03250494|Drug|Dulox capsule (60mg)|each patient received Dulox capsule (60mg) orally with sips of water 2 hours preoperatively and 100 ml 0.9% sodium chloride solution (NS) intravenous infusion (IVI) over 15 min
15951764|NCT03250494|Drug|combined Dulox capsule (60 mg) orally and Dex 0.1mg/kg diluted in 100 ml 0.9% NS IVI|each patient received combined Dulox capsule (60 mg) orally with sips of water and Dex 0.1mg/kg diluted in 100 ml 0.9% NS IVI over 15 min, 2 hours preoperatively
15951765|NCT03250494|Drug|a placebo capsule identical to Dulox capsule and 100 ml 0.9% NS IVI over 15 min, as a placebo for dexamethasone|each patient received a placebo capsule identical to Dulox capsule and 100 ml 0.9% NS IVI over 15 min, as a placebo for dexamethasone 2 hours preoperatively.
15951766|NCT03250481|Drug|Propofol|Sedation targeted to RASS -3-0 or RI 20-40
15951767|NCT03250468|Behavioral|CBT-I|Each weekly session will focus on several psychological and behavioural techniques that include sleep restriction, relaxation strategies, cognitive therapy, stimulus control therapy, and education about proper sleep hygiene.
15951768|NCT03250455|Diagnostic Test|CTA CTP|CT Angiography myocardial CT Perfusion
15951769|NCT03250455|Diagnostic Test|CTA|CT Angiography
15951770|NCT03250442|Device|PrevenaTM Device|The PrevenaTM Incision Management System covers and protects the incision from external contamination, while negative pressure removes fluid and infectious material from the surgical incision.
15951771|NCT03250442|Other|Standard Dry Dressing|These are customary dry dressings.
15951772|NCT03250429|Procedure|Sinus surgery|Standard Clinical Sinus Surgery
15951773|NCT03250403|Drug|PRP injection|peri-neural injection of platelet rich plasma
15951774|NCT03250403|Other|traditional medical treatment|traditional medical treatment
15951775|NCT03250390|Device|Collection of volatile organic compounds during exhalation|"The volatile organic compounds (VOCs) are collected in sorbents at rest and at the end of exhalation according to the concentration of carbon dioxide using ReCIVA breath sampler.
~The identification of the VOCs will be done by chromatography (Gas Chromatography Mass Spectrometry GC-MS)"
15951776|NCT03250377|Drug|Brivaracetam|"Pharmaceutical form: Film-coated tablet
~Concentration: 25 mg and 50 mg
~Route of administration: Oral use"
15951777|NCT03250364|Device|Multilayer bandage|See arm/group descriptions
15951778|NCT03250364|Device|Double compression bandage|See arm/group descriptions
15951779|NCT03250364|Device|Cohesive bandage|See arm/group descriptions
15951780|NCT03250364|Device|Adhesive compression bandage|See arm/group descriptions
15951781|NCT03250364|Device|Kinesiotaping bandage|See arm/group descriptions
15951782|NCT03250364|Other|Manual lymphatic drainage (MLD) + Intermittent Pneumatic Compression|"MLD using a modification of the strokes described by Leduc will be applied to lymphedema resorption. It will be included resorption maneuver in the oedematous areas of the affected limb, in cranial to caudal direction, since the physiotherapist seeing a change in the tissue qualities of the oedema. Then, the subjects will be received thirty minutes of Intermittent Pneumatic Compression (EureducTM) with a pression of 40 mmHg."
15951783|NCT03250364|Other|Upper limb exercises|After the bandage will be put, proprioceptive neuromuscular facilitation exercises without resistance in two diagonal in asymmetrical reciprocal patterns with the affected limb will be taught. The first diagonal into flexion from hitch hike to swat fly, and into extension from swat fly to hitch hike, and the second diagonal from hand in opposite pocket to carry tray, and into extension from carry tray to hand in opposite pocket. These exercises must be done at home two times per day, ten repetitions each exercise.
15951784|NCT03250364|Behavioral|Educational strategy|Instructions about lymphatic system anatomy and pato-physiology, the prevention and identification of possible lymphedema complication or infection, how to use and exercise this arm, avoidance of trauma, injury, an excess of heat and arm constriction.
15951785|NCT03250351|Other|Neurodynamic techniques|See arm/group descriptions
15951786|NCT03250351|Other|Early physical therapy plus educational strategy|See arm/group descriptions
15951787|NCT03250338|Drug|Crenolanib|Crenolanib will be administered orally
15951788|NCT03250338|Drug|Cytarabine|"HAM regimen
~FLAG-Ida"
15951789|NCT03250338|Drug|Mitoxantrone|HAM regimen
15951790|NCT03250338|Drug|Placebo Oral Tablet|Placebo will be administered orally
15951794|NCT03250325|Biological|TBI-1301|Split dose of TBI-1301 is administered intravenously for 2 days following cyclophosphamide pre-treatment.
15951795|NCT03250325|Drug|Cyclophosphamide|Cyclophosphamide (750mg/m2/day x 2 days Intravenous (IV)) is administered as pre-treatment medication of TBI-1301.
15951796|NCT03250312|Other|The Osteopathic Manipulation|The types of OMT techniques used will include muscle energy, articular, or high velocity-low amplitude (HVLA) as indicated by the physical findings and will be at the discretion of the treating physician. Additional techniques such as still, counter strain, facilitated positional release, balanced ligamentous tension, and cranial techniques may also be used at the discretion of the treating physician. The treatment will conclude with 2 minutes of pedal lymphatic pumping
15951797|NCT03250299|Drug|Microtubule-Targeted Agent BAL101553|Given PO
15951798|NCT03250299|Radiation|Radiation Therapy|Undergo radiation therapy
15951799|NCT03250299|Other|Laboratory Biomarker Analysis|Correlative studies
15951800|NCT03250299|Other|Pharmacological Study|Correlative studies
15951801|NCT03250286|Device|EUS|"Endoscopic ultrasound (EUS) is performed with radial scanning echo endoscope (Olympus GF UE260) by four endosonographers.
~EUS examination is performed first, and if there is choledocholith, ERCP is performed."
15951802|NCT03250286|Device|ERCP|"Endoscopic retrograde cholangiopancreatography (ERCP) is performed with duodenoscope (Olympus JF-260V or TJF-260V) by four endoscopists.
~In the EUS-ERCP group, ERCP is used to remove bile duct stones diagnosed via EUS. Therefore, only ERCP is performed in patients with choledocholithiasis in EUS.
~In the ERCP group, diagnosis and treatment of bile duct stones are performed with ERCP."
15951803|NCT03250273|Drug|Entinostat|Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle).
15951804|NCT03250273|Drug|Nivolumab|After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).
15951805|NCT03250273|Drug|Entinostat|Entinostat (5mg) will be administered starting with 2 lead-in doses at 14 and 7 days before the first dose of nivolumab in combination with entinostat. After the lead-in dose, entinostat will be administered once a week (days 1, 8, 15, and 21 of each treatment cycle).
15951806|NCT03250273|Drug|Nivolumab|After both lead-in doses of entinostat, nivolumab (240 mg) will be administered every 2 weeks (day 1 and day 15 of a cycle).
15951807|NCT03250260|Other|3-dimensional photograph with simulation|The viewing of a 3-dimensional simulation is classed as an intervention as it strays from the normal pre-operative preparation.
15951808|NCT03250260|Other|Viewing of a 2-dimensional photographic library|The viewing of a 2-dimensional photograph library is classed as an intervention as it strays from the normal pre-operative preparation.
15951809|NCT03250247|Device|Stents|"US-guided puncture of vein, fluoroscopic monitoring of catheter/guidewire manipulations, baseline venogram of CFV through infrarenal IVC.
~Iliac vein should be pre-dilated to at least 12 mm. Bare, self-expanding stents made of elgiloy or nitinol legally marketed in the US for any indication and that are at least 12 mm in diameter should be used to recanalize the entire diseased segment of vein.
~The use of devices > 14 mm is highly recommended for the iliac vein and dilated to at least 14 mm, unless compelling patient factors dictates dilatation to a smaller diameter.
~Balloon angioplasty of inflow veins.
~After successful iliac vein recanalization, patients who continue to be symptomatic beyond 2 weeks follow-up and who have valvular reflux in GSV, accessory GSV, anterolateral thigh circumflex, and/or SSV should be offered endovenous ablation.
~Any FDA-approved method may be used including radiofrequency or laser ablation, sclerotherapy or pharmacomechanical ablation."
15951810|NCT03250234|Other|Adequate Carbohydrate|During the 3-hr recovery period after glycogen depletion participants will consume a carbohydrate (1 g/kg/hr) beverage For the day participants will consume a diet of 6.0 g/kg/d carbohydrate following glycogen depletion
15951811|NCT03250234|Other|Low Carbohydrate|"During the 3-hr recovery period after glycogen depletion participants will consume a nutrient free beverage.
~For the day participants will consume a diet of 1.2 g/kg/d carbohydrate following glycogen depletion"
15951812|NCT03250221|Device|barbed sutures|Use of the barbed sutures for robotic or laparoscopic myomectomy
15951813|NCT03250221|Device|Vicryl@ suture|Use of Vicryl@ suture for robotic or laparoscopic myomectomy
15951814|NCT03250208|Dietary Supplement|Probiotic|Participants randomized to the intervention group will receive Women's Fem Dophilus ® by Jarrow Formulas.
15951815|NCT03250208|Other|Placebo|Participants randomized to the control group will receive a placebo containing no active ingredients
15951816|NCT03250195|Diagnostic Test|PET/MRI|PET/MRI scan
15951817|NCT03250182|Drug|PT010|PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations per use as instructed per the protocol.
15951818|NCT03250169|Drug|Alemtuzumab|Licensed dose
15951819|NCT03250156|Behavioral|MBAT with proctored practice|The training program is known as Mindfulness-Based Attention Training, or MBAT. The MBAT program is based on the principles of Mindfulness-Based Stress Reduction, but contextualized for military personnel using themes relevant to military life. The training content is comprised four central themes: concentration, body awareness, open monitoring, and compassion. Participants will have proctored practice and complete the assigned, out-of-class mindfulness exercises during the duty day as party of their physical training.
15951820|NCT03250156|Behavioral|MBAT with non-proctored practice|The training program is known as Mindfulness-Based Attention Training, or MBAT. The MBAT program is based on the principles of Mindfulness-Based Stress Reduction, but contextualized for military personnel using themes relevant to military life. The training content is comprised four central themes: concentration, body awareness, open monitoring, and compassion.Participants will not have proctored practice and will complete the assigned, out-of-class mindfulness exercises on their own.
15951821|NCT03250143|Drug|cyclosporine vs azathioprine|Group A cyclosporine 3mg/kg/day and group B azathioprine 1mg/kg/day
15951822|NCT03250130|Behavioral|hypnosis|The patient achieve self-hypnosis sessions in these chemotherapy treatments
15951823|NCT03250117|Drug|Ropinirole oral product|oral immediate-release ropinirole
15951824|NCT03250117|Drug|Ropinirole Implant|ropinirole hydrochloride/ethylene vinyl acetate
15951921|NCT03249402|Drug|Ethinyl Estradiol + Levonorgestrel|Participants will receive one OC tablet containing EE 0.03 mg and LN 0.15 mg once daily on Days 1 to 21 in cycles 1 and 2.
15951825|NCT03250104|Other|Infection Control|The infection control bundle will include staff training, hand hygiene programs, disinfection measures, and contact isolation. Physicians will be discouraged to prescribe proton pump inhibitors (PPIs) where not explicitly needed. The intervention bundle will be defined based on current literature. For implementation, the investigator will adapt the bundle to specific local needs, discuss with the responsible department heads and ward staff, perform training and disseminate standards of care.
15951826|NCT03250104|Other|Antibiotic Stewardship|"Antibiotic stewards will develop local standards of procedure based on the provided training and guidelines. They will then train the responsible staff and disseminate guidelines as best suited for the local work environment, e.g. as pocket cards, posters, or electronically. Point-prevalence investigations and antibiotic visits will assure adherence to guidelines."
15951827|NCT03250091|Procedure|Upper endoscopy with biopsies|Upper endoscopy with proper biopsy work-up will be used for identification and stratification of gastric lesions as well as acquisition of biopsies for histopathological examination, including H.pylori detection
15951828|NCT03250091|Procedure|Plasma/serum sampling|Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination, serum biomarkers
15951829|NCT03250091|Procedure|Biopsies for gastric microbiota|During upper endoscopy biopsies for gastric microbiota analysis will be obtained
15951830|NCT03250091|Procedure|Faecal sample acquisition|Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
15951831|NCT03250078|Diagnostic Test|MRI/MRCP|An MRI/MRCP plus IV gadolinium contrast with high resolution imaging of the pancreas will be performed annually
15951832|NCT03250065|Device|Application of prototype sensor to a standard endotracheal tube|During anaesthesia the device under study, a prototype saturation sensor will be applied to a standard endotracheal tube that ventilates the patient as normal.
15951833|NCT03250052|Drug|(fimasartan or linagliptin) x 7days|Part A: fimasartan, Part B: linagliptin
15951834|NCT03250052|Drug|(fimasartan and linagliptin) x 7days|Part A & Part B: Co-administration of fimasartan and linagliptin
15951835|NCT03250039|Drug|PF-04965842|14C labeled PF-04965842
15951836|NCT03250039|Drug|Absolute Bioavailability|Oral dose of unlabeled PF-04965842 and an IV dose of 14C labeled PF- 04965842
15951837|NCT03250026|Behavioral|Workplace convergence dialogue|Work place contact as a convergence dialogue between the employer and employee with the Rehab Coordinator as a guide
15951838|NCT03250026|Behavioral|Care Manager|Regular contact Care Manager during around 12 weeks
15951839|NCT03250013|Drug|ADHD medications|
15951840|NCT03249987|Other|bladder diary|electronic diary to be completed for 3 days before crossover onto paper diary for 3 days
15951841|NCT03249974|Device|Enlite sensor communicating with Minimed 640G pump|Children (5 to 18 years) with type 1 diabetes mellitus treated with an insulin pump and wearing a FreeStyle Flash Libre glucosesensor will switch to the Enlite sensor communicating with Minimed 640G pump
15951842|NCT03249961|Device|Sham TDCS|Placebo stimulation is applied to the left motor cortex while participants perform a motor task in the right hand. During the motor task, participants use their right hand to pinch a force transducer that controls an on-screen cursor to navigate between a start position and a sequence of 5 other positions to the right.
15951843|NCT03249961|Device|Anodal TDCS|Excitatory stimulation is applied to the left motor cortex while participants perform a motor task in the right hand. During the motor task, participants use their right hand to pinch a force transducer that controls an on-screen cursor to navigate between a start position and a sequence of 5 other positions to the right.
15951844|NCT03249961|Device|Transcranial Magnetic Stimulation (TMS)|Participants will receive Transcranial Magnetic Stimulation (TMS) to allow research investigators to determine the location of the left motor cortex.
15951845|NCT03249948|Procedure|Vector change defibrillation|Defibrillation using pad placement in anterior-posterior position.
15951846|NCT03249948|Procedure|Double-sequential defibrillation|Defibrillation using two defibrillators, one with pad placement in anterior-posterior position, and the other with pad placement in anterior-anterior position, delivering two rapid sequential shocks.
15951847|NCT03249935|Drug|Azithromycin|Azithromycin 1 gm PO single dose given as directly observed
15951848|NCT03249922|Device|Spinal Cord Stimulation|Implantation of a spinal cord stimulator for the control of axial back or neuropathic pain.
15951849|NCT03249909|Device|Exufiber Ag+|gelling fibre dressing with silver
15951850|NCT03249909|Device|Exufiber|gelling fibre without silver
15951851|NCT03249909|Device|Aquacel Ag Extra|gelling fibre with silver
15951852|NCT03249896|Behavioral|Habits-GDM mobile app|The intervention is a self-administered mobile app designed for GDM. It targets behavioural change by providing personalised GDM management program which consists of three main elements: lessons, tracking and coaching/feedback. Lessons contains 12 interactive modules which provide patient education on GDM. Each lesson will take approximately 10-20 minutes. Information on SMBG (linked to the Aina or Aina Mini device), weight (linked to the Bluetooth weighing scale), physical activity (physical activity tracking function in the app), and food (equipped with common local food using the Singapore food database) can be tracked and displayed visually. An interactive messaging platform is used for coaching. Generic and customised automated messages are sent from a virtual lifestyle coach to encourage and motivate patients towards healthy behaviour beneficial for GDM.
15951853|NCT03249883|Device|SACH prosthetic foot, 1M10 prosthetic foot|"In the SACH first group - the amputees will wear the SACH feet for three weeks and then switch to 1M10 feet for another three weeks.
~In the 1M10 first group - the amputees will wear the 1M10 feet for three weeks and then switch to SACH feet for another three weeks."
15951854|NCT03249870|Drug|Inotuzumab ozogamicin (INO)|"INO schedule of administration is as follows:
~First induction course: 0.8 mg/m² on day 1, 0.5 mg/m² on day 8, and 0.5 mg/m² on day 15
~Second induction course: 0.5 mg/m² on day 1, and 0.5 mg/m² on day 8"
15951855|NCT03249857|Behavioral|cognitive tasks + IQ + MINI|"Patients will perform different tasks:
~cognitive tasks : reaction time (Alert TEA, Zimmermann and Fimm, 2005) + Edinburgh laterality questionnaire (Oldfield,1971) + hamilton and young's scale (Tohen et al., 2009) + Montreal Cognitive Assessment (MoCA) (Nasreddine et al., 2005) + experimental task (approach/ avoidance and affordance task).
~Intelligence Quotient (IQ) test (PM38, Raven, 1960)
~Mini International Neuropsychiatric Interview (MINI, Van Vliet et al., 2006)"
15952140|NCT03247712|Procedure|Surgical Resection|Surgical Resection of Tumor
15951856|NCT03249857|Behavioral|cognitive tasks|Healthy volunteers will perform only the cognitive tasks = reaction time alert TEA, Zimmermann and Fimm, 2005 + Edinburgh laterality questionnaire (Oldfield, 1971) + experimental task (approach/ avoidance and affordance task).
15951857|NCT03249844|Drug|Methylprednisolone + prednisolone|"The experimental intervention consists of 5 consecutive days Methylprednisolone at a daily single intravenous dose of 20 mg/kg body-weight (max 1 g/day) followed by a 4-week course of tapering Prednisolone given at a daily single oral dose in the morning:
~week 1 and 2, oral Prednisolone 1 mg/kg/day (max 40 mg/day), ,
~week 3 and 4, oral Prednisolone 0,5 mg/kg/day (max 20 mg/day),"
15951858|NCT03249831|Drug|Cyclophosphamide|Orally daily
15951859|NCT03249831|Drug|Pentostatin|Intravenous
15951860|NCT03249831|Drug|Rabbit anti-thymocyte globulin|Intravenous
15951861|NCT03249831|Drug|Tacrolimus|Initially IV. If patient tolerates, convert to oral.
15951862|NCT03249831|Drug|Mycophenolate mofetil|IV or oral
15951863|NCT03249831|Biological|CD4+ T-cell-depleted Haploidentical Hematopoietic Transplant|Infusion
15951864|NCT03249818|Device|HITT device|Device scans the fovea of the eye to measure fixation. Patients will then be asked to track the fixation target across an area the size of a playing card, with the device tracking the participant's fixation throughout.
15951865|NCT03249805|Device|Steenbeek Foot Abduction Brace (SFAB)|The FAB will be equipped with discretely hidden sensors; subjects and their families will not be aware of the actual function of the sensor in order to avoid increased compliance due to the sensor. Sensors work on the principle of force-sensing resistor material whose resistance changes when a force or pressure is applied. Force-sensing resistors consist of a conductive polymer, which changes resistance in a predictable manner following application of force to its surface. On the top of braces sole we have fixed force resistive sensor (FSR), which changes resistance whenever force is applied. Threshold of detection is 30-40 gram. The changes of resistance is detected by using micro-controller.
15951866|NCT03249805|Device|MiracleFeet Foot Abduction Brace (mFAB)|Sensors in the mFAB will measure whether the shoe is on, the foot is in contact with the sole of the shoe and the shoes are clipped into the bar. Sensors work on the principle of force-sensing resistor material whose resistance changes when a force or pressure is applied. Force-sensing resistors consist of a conductive polymer, which changes resistance in a predictable manner following application of force to its surface. On the top of braces sole we have fixed force resistive sensor (FSR), which changes resistance whenever force is applied. Threshold of detection is 30-40 gram. The changes of resistance is detected by using micro-controller.
15951867|NCT03249792|Drug|MK-2118 (IT)|IT injection
15951868|NCT03249792|Drug|MK-2118 (SC)|SC injection
15951869|NCT03249792|Biological|Pembrolizumab|IV infusion
15951870|NCT03249779|Device|Scrambler|Scrambler Therapy is a specific form of electrical stimulation which has also been utilized in chronic neurogenic pain11. This modality of therapy differs from TENS in that the goal is to mediate the patient's perception of pain, rather than masking the peripheral pain signal. The results of this modality of treatment may be longer-lasting than TENS, presumably via reduction in central signal generation. Scrambler therapy works through C fibers to retrain the peripheral sensation in the area being treated. Further description of this technology is available at: International Patent PCT/IT2007/000647 and U.S. Patent No. 8,380,317. Literature search does not yield prior studies regarding efficacy of Scrambler therapy in treating RLS
15951871|NCT03249766|Other|Observational|Observational study
15951872|NCT03249753|Drug|SPH3127 200mg Panel A|Participants who are in panel A will receive a single dose of a SPH3127 tablets 200mg when limosis, then fast 4h after dosing, and 72 hours later participants take the second dose of SPH3127 200mg after a high-fat breakfast.
15951873|NCT03249753|Drug|SPH3127 200mg Panel B|Participants who are in panel B will receive a single dose of a SPH3127 tablets 200mg after a high-fat breakfast, then 72 hours later participants take the second dose of SPH3127 200mg when limosis.
15951874|NCT03249740|Drug|GB-102|Intravitreal injection of GB-102
15951875|NCT03249740|Drug|Aflibercept|Intravitreal injection of Aflibercept.
15951876|NCT03249727|Diagnostic Test|IVDD for NK cell activity in whole blood|Once subject has been scheduled for a colonoscopy by the institution (up to 4 weeks prior to procedure), the subject will perform a FIT at home and an NK Vue test (one sample of one mL of blood) at the institution, prior to the day of colonoscopy.
15951877|NCT03249714|Drug|Ofatumumab|Provided in pre-filled syringes for subcutaneous injection (s.c.) administration containing 20 mg ofatumumab (50 mg/mL, 0.4 mL content)
15951878|NCT03249714|Drug|Matching placebo of ofatumumab|Matching placebo in pre-filled syringes
15951879|NCT03249701|Device|Transcutaneous Electrical Acupoint Stimulation|The intervention will be administered by electrical acupoint machine, the brand is Great Wall.
15951880|NCT03249701|Device|Electroacupuncture|The intervention will be administered by electrical acupoint machine, the brand is Great Wall.
15951881|NCT03249701|Device|sham Transcutaneous Electrical Acupoint Stimulation|The intervention will be administered by transcutaneous electrical acupoint machine, even no truly actualized.
15951882|NCT03249688|Other|Regular health advice|Routine healthy lifestyle counseling
15951883|NCT03249688|Behavioral|Multidomain lifestyle|Nutritional guidance, exercise, cognitive training, vascular risk monitoring
15951884|NCT03249688|Dietary Supplement|Medical food|Medical food product (Fortasyn Connect)
15951885|NCT03249662|Procedure|bupivacaine 200 mg|bupivacaine 200 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration
15951886|NCT03249662|Drug|bupivacaine 100 mg|bupivacaine 100 mg ketorolac 30 mg epinephrine 400 mcg add NSS to 80 ml divided to two syringes for bilateral periarticular infiltration
15951887|NCT03249649|Behavioral|Comprehensive Healthcare Needs Assessment|Questionnaire focused on existing healthcare communication, treatment and services plus community needs in those three areas.
15951888|NCT03249636|Diagnostic Test|Flow cytometric analysis|Level of expression of the markers and the correlation between the markers with each other and with the clinical presentation and impact on patients with ALL.
15951920|NCT03249428|Device|Improved Quality of Life of low-income Canadians that smoke tobacco and other substances|Assess effectiveness, safety and tolerability of electronic-cigarettes (e-cigs) with nicotine or Nicotine Replacement Therapy (NRT) with individual counseling for tobacco cessation.
15952141|NCT03247712|Radiation|Radiation (5 days)|8Gy x 5 (Mon-Fri) GTV+3mm
15951889|NCT03249623|Device|Beacon Caresystem|The core of the system is a set of physiological models including pulmonary gas exchange, acid-base chemistry, lung mechanics, and respiratory drive. The Beacon Caresystem tunes these models to the individual patient such that they describe accurately current measurements. Once tuned, the models are used by the system to simulate the effects of changing ventilator settings. The results of these simulations are then used calculate the clinical benefit of changing ventilator settings by balancing the competing goals of mechanical ventilation.
15951890|NCT03249610|Behavioral|Lifestyle intervention|Intervention Trial with Multi-Component Lifestyle Intervention for reduction of body weight and cardio-metabolic risk factors
15951891|NCT03249597|Diagnostic Test|Blood test: Glukos, SuPAR, Laktat and HBP|"Four blood tests described in the section Biospecimen Description are analyzed within the main study; Glukos, SuPAR, Laktat and HBP."
15951892|NCT03249584|Device|OsteoCool™ RF Ablation|The OsteoCool™ RF Ablation system is indicated in the United States (US), Europe (EUR) and Canada (CAN) for patients with metastatic malignant lesions in a vertebral body, painful metastatic lesions involving bone (in the US, patients with metastatic lesions involving the bone must have failed or were not candidates for standard therapy) and benign bone tumors such as osteoid osteomas.
15951893|NCT03249571|Dietary Supplement|Flavonoid supplement|2-weeks ingestion of flavonoid supplement
15951894|NCT03249571|Dietary Supplement|Placebo|2-week ingestion of placebo supplement
15951895|NCT03249558|Drug|Morphine|Subjects will be randomized into one of the treatment groups and will follow the assigned medication schedule for 10 weeks. Quantitative Sensory Testing (QST) will be performed on the subjects to compare pain threshold, pain tolerance, and wind up.
15951896|NCT03249558|Drug|Duloxetine|Subjects will be randomized into one of the treatment groups and will follow the assigned medication schedule for 10 weeks. Quantitative Sensory Testing (QST) will be performed on the subjects to compare pain threshold, pain tolerance, and wind up.
15951897|NCT03249558|Drug|Placebo|Subjects will be randomized into one of the treatment groups and will follow the assigned medication schedule for 10 weeks. Quantitative Sensory Testing (QST) will be performed on the subjects to compare pain threshold, pain tolerance, and wind up.
15951898|NCT03249532|Device|standard hemodialysis|hemodialysis with high-flux dialyzer; prescription of dialysate temperature: 36.5 degrees Celsius; convection volume: not applicable
15951899|NCT03249532|Device|cool hemodialysis|hemodialysis with high-flux dialyzer; prescription of dialysate temperature: 35.5 degrees Celsius; convection volume: not applicable
15951900|NCT03249532|Device|low volume hemodiafiltration|hemodiafiltration; prescription of dialysate temperature: 36.5 degrees celsius prescription of convection volume: 15 L
15951901|NCT03249532|Device|high volume hemodiafiltration|hemodiafiltration; prescription of dialysate temperature: 36.5 degrees celsius prescription of convection volume: 25 L
15951902|NCT03249519|Radiation|Radiation|50.4 Gy
15951903|NCT03249519|Radiation|brachytherapy|35-40 Gy
15951904|NCT03249519|Drug|Cisplatin|weekly 40 mg/m^2 (6cycles)
15951905|NCT03249519|Other|Hyperthermia|10 times
15951906|NCT03249506|Drug|Canagliflozin|Participants who received canagliflozin as a part of routine clinical practice and met new user criteria, will be included in SGLT2i new user group.
15951907|NCT03249506|Drug|Empagliflozin|Participants who received empagliflozin as a part of routine clinical practice and met new user criteria, will be included in SGLT2i new user group.
15951908|NCT03249506|Drug|Dapagliflozin|Participants who received dapagliflozin as a part of routine clinical practice and met new user criteria, will be included in SGLT2i new user group.
15951909|NCT03249506|Drug|Dipeptidyl Peptidase-4 Inhibitor (DPP-4)|Participants who received a DPP-4 as a part of routine clinical practice and met new user criteria, will be included in non-SGLT2i new users group.
15951910|NCT03249506|Drug|Glucagon-Like Peptide-1 Agonist (GLP-1)|Participants who received a GLP-1 as a part of routine clinical practice and met new user criteria, will be included in non-SGLT2i new users group.
15951911|NCT03249506|Drug|Thiazolidinedione (TZD)|Participants who received a TZD as a part of routine clinical practice and met new user criteria, will be included in non-SGLT2i new users group.
15951912|NCT03249506|Drug|Sulfonylureas|Participants who received a sulfonylureas as a part of routine clinical practice and met new user criteria, will be included in non-SGLT2i new users group.
15951913|NCT03249506|Drug|Insulin|Participants who received a insulin as a part of routine clinical practice and met new user criteria, will be included in non-SGLT2i new users group.
15951914|NCT03249493|Other|Blood sample on DBS|"We will take 5 mL of whole blood at ART initiation, 6, 12 and 24 months of follow up after ART initiation. Blood will be transferred on DBS cards.
~HIV Viral Load measurements will be done and HIV Drug Resistance measurements will be performed in case of 2 consecutive VL results > 1000 cp/mL"
15951915|NCT03249480|Biological|PEG-somatropin|30IU/10 mg/3ml/kit, 0.1-0.2mg /kg/w, once per day for 26 weeks.
15951916|NCT03249454|Device|Anodal tsDCS|During Anodal tsDCS intervention the positive end of the battery will be connected to the electrode on participant's back and negative end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.
15951917|NCT03249454|Device|Cathodal tsDCS|During Cathodal tsDCS intervention the negative end of the battery will be connected to the electrode on participant's back and positive end of the battery will be connected to the electrode on participant's shoulder. The battery will be turned on for 15 minutes, and the stimulation strength will be adjusted a couple of times per tolerance level.
15951918|NCT03249454|Device|Sham tsDCS|During Sham tsDCS intervention, battery will be turned off and no current will pass through the electrodes.
15951919|NCT03249441|Behavioral|Compassion-focused therapy|"Session-by-session summary of CFT:
~Week 1: Understanding your relationship with food Week 2: Making sense of overeating Week 3: The Compassionate Mind/ Preparing your mind for compassion Week 4: Developing the skill of self-compassion Week 5: Why we overeat - a Compassionate approach Week 6: Understanding your current eating pattern Week 7: Motivating yourself to change Week 8: Determining what your body needs Week 9: Towards a new way of eating Week 10: Compassionate letter writing and developing a compassionate focus on eating.
~__________________________________________________________________________"
15951922|NCT03249402|Drug|JNJ-42847922|Participants will receive 40 mg of JNJ-42847922 once daily on Days 14 to 21 in cycle 2.
15951923|NCT03249389|Biological|Blood sample|patients will have a blood sample of 20 ml (4 x 5ml) for inclusion, the J1 of each course and at the end of treatment
15951924|NCT03249376|Drug|Lumateperone|Lumateperone (ITI-007 60 mg)
15951925|NCT03249376|Other|Placebo|Placebo
15951926|NCT03249363|Procedure|Group A - Pulsed PVP-I Irrigation|
15951927|NCT03249350|Behavioral|Standard Contingency Management (CM)|"CM utilizes behavior modification & cognitive behavioral strategies to target adolescent substance use. Protocol components are as follows: (a) The provider introduces CM to the youth and caregiver and engages them in the intervention; (b) The provider conducts Antecedent-Behavior-Consequence (ABC) assessments of the youth's AOD use with the youth and caregiver; (c) Based on the results of the ABC assessments, self-management planning and drug refusal skills training are implemented by the provider in collaboration with the youth and caregiver; (d) Concurrently, a point and level system contract is established with the family, which provides the youth with rewards/privileges for negative drug and alcohol tests and disincentives (e.g., extra chores) for positive tests. Until continued abstinence is achieved, components b through d are repeated; (e) The provider collaborates with the family to develop plans for sustaining long-term abstinence. Typical duration of CM is 12-16 weeks."
15951928|NCT03249350|Behavioral|Enhanced Contingency Management (CM+)|The CM+ protocol adds the behavioral assessment and teaching system from Parent Management Training Oregon (PMTO) to standard CM to enhance parent's skill acquisition more intensely. PMTO's behavioral assessment and teaching system uses three processes to bring about changes in parenting: daily parent reports on youth behavior, anti-coercive problem-solving, and structured learning and in vivo practice of new parenting techniques.
15951929|NCT03249337|Drug|Ripasudil hydrochloride hydrate 0.4% ophthalmic solution|"the ophthalmic solution will be administered three or six per times per day in the eye designated as the Study Eye upon study enrollment"
15951930|NCT03249324|Behavioral|Positive-Gain Counseling (PGC)|Positive-gain-based health promotion interventions capitalize on the basic human desire to maintain consistency between one's words and actions for beneficial outcomes. Participants will be asked to discuss potential adverse effects of obesity, an unhealthy diet, and sedentary behavior, as well as the benefits of maintaining a physically fit body, eating a healthy diet, and regular physical activity. They will also discuss the costs and benefits as they apply to developing children. Theoretically, discussing and reviewing these perspectives will make the mothers more apt to make healthier lifestyle choices in the future. Women randomized to the positive-gains counseling (PGC) group will have PGC sessions once during each trimester and at 2 weeks, 2 months, 4 months and 6 months postpartum. PGC participants will also receive prenatal care in accordance with the VA/DoD Guideline for the Management of Pregnancy.
15951931|NCT03249324|Other|Usual Care|Women in the usual care (UC) group will receive prenatal care in accordance with the VA/DoD Guideline for the Management of Pregnancy. This entails regular clinic visits, routine blood and urine screening tests, and anticipatory guidance. Routine well-child care appointments will take place at 2-3 days, 2 weeks, 2 months, 4 months, 6 months, 9 months and 12 months after birth. During routine well-child visits, height, weight, and vital signs are measured, developmental milestones are reviewed, and a thorough physical examination is performed. Age-appropriate immunizations are provided as is parental anticipatory guidance, including the importance of breastfeeding. Participants enrolled in the UC group will receive anticipatory guidance from their primary care provider in the usual fashion. Providers will deliver this anticipatory guidance with no external cues or counseling provided by the research team.
15951932|NCT03249311|Drug|Levomilnacipran|Escalating doses of 40 to 120mg/day every 7 days (+/- 1 day) throughout a 20-26 day period.
15951933|NCT03249311|Drug|Duloxetine|Escalating doses of 40 to 120mg/day every 7 days (+/- 1 day) throughout a 20-26 day period.
15951934|NCT03249311|Drug|Placebos|Escalating doses of 40 to 120mg/day every 7 days (+/- 1 day) throughout a 20-26 day period.
15951935|NCT03249298|Drug|Sterofundin (Bolus of crystalloids)|Bolus of 250 ml crystaloids infused regarding the measures
15951936|NCT03249298|Drug|Voluven (Bolus of colloids)|Bolus of 250 ml colloids infused regarding the measures
15951937|NCT03249285|Drug|Peri|Perindopril 4 mg /day, orally with titration to 8 mg/day after 1 month if BP (Blood pressure) is not controlled
15951938|NCT03249285|Drug|HCTZ|Hydrochlorothiazide 12, 5 mg day, orally with titration to 25 mg/day after 1 month if BP is not controlled
15951939|NCT03249272|Drug|Regadenoson|Microvascular disease will be considered present if regional perfusion defects are observed or global perfusion reserve is reduced. For the assessment of microvascular disease, the adenosine and regadenoson groups will be combined, as the medications are considered interchangeable.
15951940|NCT03249272|Drug|Adenosine|Microvascular disease will be considered present if regional perfusion defects are observed or global perfusion reserve is reduced. For the assessment of microvascular disease, the adenosine and regadenoson groups will be combined, as the medications are considered interchangeable.
15951941|NCT03249259|Drug|Choline alfoscerate|Treatment duration is 6 months and can be extended to 12 months with participant's agreement.
15951942|NCT03249259|Drug|Placebo|Treatment duration is 6 months and can be extended to 12 months with participant's agreement.
15951943|NCT03249246|Other|No intervention|
15951944|NCT03249233|Device|ZenLens™|The ZenLens™ semi-scleral lenses are manufactured by Alden Optic Laboratories Inc., Lancaster, NY. They will be made in Boston XO material.
15951945|NCT03249233|Device|Zen™ RC|The Zen™ RC semi-scleral lenses are manufactured by Alden Optic Laboratories Inc., Lancaster, NY. They will be made in Boston XO material.
15951946|NCT03249220|Device|Placement of the CBMS Probe|Patients will be treated according to standard care in place at the investigation site, when intra-ventricular drainage is needed. Patients will receive the new multifunctional device (CBMS Probe) instead of the single function device generally used. Drainage will be performed by routine standards. Temperature, intracranial pressure and cerebral blood flow will be recorded. Treatment decision will be made by the neurointensive care specialist based on standard care.
15951947|NCT03249207|Drug|IL-1Ra|Doses to be administered subcutaneously (SC) twice daily (12 hourly) starting within 72 hours of ictus (onset of symptoms) for a maximum of 21 days from ictus (or sooner if discharged from neurosurgical centre).
15951948|NCT03249207|Drug|IL-1Ra Placebo|Doses to be administered subcutaneously (SC) twice daily (12 hourly) starting within 72 hours of ictus (onset of symptoms) for a maximum of 21 days from ictus (or sooner if discharged from neurosurgical centre).
15951949|NCT03249194|Drug|Direct acting Anti-Viral Therapy using Epclusa or Zepatier|All patients will receive one 'on-call' dose of SOFOSBUVIR/VELPATASVIR (Epclusa, Gilead) immediately prior to transplant and one dose on post-operative Day 1 post-transplant. Patients who develop detectable HCV viremia will be initiated on Direct Acting Anti-viral (DAA) therapy between 2-4 weeks post-transplant. Patients with GT1 will be treated with ELBASVIR/GRAZOPREVIR (Zepatier, Merck) and those with GT2 or 3 will be treated with SOFOSBUVIR/VELPATASVIR (Epclusa, Gilead) based upon donor genotyping results
15951950|NCT03249181|Drug|Dolutegravir|Patients randomized to the study drug will be commenced on an antiretroviral regimen comprising DTG 50mg once daily in combination with 2 NRTIs
15951951|NCT03249181|Drug|Standard of Care (EFV + 2 NRTI backbone)|Patients randomized to receive standard of care will receive the currently used antiretroviral regimens in keeping with national policy.
15951952|NCT03249168|Drug|Duloxetine 60mg|tablet
15951953|NCT03249168|Drug|Placebo|Tablet
15951954|NCT03249155|Behavioral|AO - plus sonification|patients re-learn 8 motor gestures watching video-clips showing an actor performing the same gestures, and then tried to repeat the gesture. Each video-clip is composed by images and sounds of the gestures. The sound of gestures is obtained with the sonification technique, by transforming kinematic data (velocity) recorded during the execution of gesture, into pitch variations (for an example see: bit.ly/sonif_example)
15951955|NCT03249155|Behavioral|CUE - visual and auditory|patients re-learned 8 motor gestures practicing a traditional protocol combining visual and auditory cues
15951956|NCT03249142|Drug|ARM A Durvalumab/chemotherapy association|"NEO-ADJUVANT Cycle 1 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV alone (day1), every 3 weeks Cycle 2 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV + durvalumab 1125 mg IV (day1) Cycle 3 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV + durvalumab 1125 mg IV (day1)
~ADJUVANT :
~If complete surgical resection at interval debulking surgery : 3 cycles of durvalumab 1125 mg IV + carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV at day1, every 3 weeks.
~If residual tumor at interval debulking surgery : the tremelimumab 75 mg IV will be added to the durvalumab-chemotherapy combination at day 1 of cycle 2 before a salvage surgery. Durvalumab 1125 mg IV (with one cycle of tremelimumab 75 mg IV post S3) will be pursued in maintenance treatment, up to 1 year or until disease progression, unacceptable toxicity or patient withdrawn."
15951957|NCT03249142|Drug|ARM B Durvalumab/Tremelimumab/chemotherapy association|"NEO-ADJUVANT Cycle 1 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV alone (day1), every 3 weeks Cycle 2 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV + durvalumab 1125 mg IV + tremelimumab 75 mg IV (day1) Cycle 3 : carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV + durvalumab 1125 mg IV (day1)
~ADJUVANT :
~If complete surgical resection at interval debulking surgery : 3 cycles of durvalumab 1125 mg IV + carboplatin AUC 5 IV + paclitaxel 175 mg/m² IV at day1, every 3 weeks.
~If residual tumor at interval debulking surgery : patients will be treated according to investigator choice."
15951958|NCT03249116|Other|animal-assisted intervention|Interaction with a therapy dog
15951959|NCT03249116|Other|active control|Interaction with a stuffed dog
15951960|NCT03249103|Drug|NYX-2925|NYX-2925 is a novel small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
15951961|NCT03249103|Drug|Placebo oral capsule|Matching placebo capsules.
15951962|NCT03249090|Other|Patient Self-Reporting of Symptoms|"At baseline, CRAs will train patients to self-report symptoms and physical functioning weekly for up to a year, with a choice to do so online or via an automated telephone system. Whenever a concerning symptom is reported, an automated email alert notification will be sent to the site CRA. The CRA will forward the alert to the responsible clinical nurse (or other covering clinician) and CC the site's Nurse Champion. Within 72 hours, the CRA will document what action(s), if any, were taken by the nurse in response to the alert (entered by the CRA into a form in the PRO-Core system). A symptom report will be printed/generated by the site CRA whenever the patient has a clinic visit and will be given to the oncologist and nurse caring for the patient."
15951963|NCT03249090|Other|Usual Care Delivery|Patients receive routine cancer care delivery with no additional systematic monitoring of symptoms
15951964|NCT03249077|Behavioral|Digital DPP|The online DPP program is 12 months in duration with 16 core sessions delivered over 16-26 weeks and 6 maintenance sessions delivered over 6 months.
15951965|NCT03249077|Behavioral|In-person DPP|The in-person DPP program is 12 months and consists of weekly sessions for the first 6 months and monthly sessions for the remaining 6 months.
15951966|NCT03249077|Other|DPP not enrolled|Access to usual care services without restrictions.
15951967|NCT03249064|Diagnostic Test|CD 91 levels|
15951968|NCT03249064|Diagnostic Test|Tregs|
15951969|NCT03249051|Other|Indirect Calorimetry|Energy need is being determined using indirect Calorimetry
15951970|NCT03249038|Other|Measurement of external blood loss|
15951971|NCT03249038|Diagnostic Test|Serum Hemoglobin concentration|
15951972|NCT03249025|Drug|Lidocaine|Initial dose of 5.0 mg/kg (based on actual weight, up to maximum dose 600 mg) over 45-60 minutes, followed by increases of 0.5 mg/kg each infusion based on tolerability of side effects, to a maximum total dose of 600 mg. The initial and subsequent dose may be increased or decreased by 20% based on patient comorbidities, age and previous experience
15951973|NCT03249025|Drug|Ketamine|initial dose of 0.25 mg/kg (based on actual weight) over 45-60 minutes (rounded to nearest 5 mg), increased by 10mg each infusion based on tolerability of side effects. The initial and subsequent dose may be increased or decreased by 20% based on patient comorbidities, age and previous experience
15951974|NCT03249012|Other|Empiric use of Calcium Carbonate and Calcitriol|Empiric calcium carbonate and calcitriol repletion
15951975|NCT03249012|Other|PTH based Calcium Carbonate and Calcitriol repletion|PTH based treatment
15951976|NCT03248999|Diagnostic Test|rectal swab|stool samples by rectal swab
15951977|NCT03248986|Other|Dry needling|Dry needling of the spastic muscles of the affected arm through DNHS®.
15951978|NCT03248973|Drug|Ampicillin Injection|Ampicillin injection 2 g q4h for 3 weeks
15951979|NCT03248960|Diagnostic Test|iTreat Flu A+B Test|The iTreat Flu A+B Test is a rapid in vitro diagnostic test for the detection of influenza A or influenza B in nasal swab samples. The iTreat Flu A+B Test is designed to be simple to use and generates a result within 15 minutes.
15951980|NCT03248960|Diagnostic Test|ellume.lab Flu A+B Test|The ellume.lab Flu A+B Test is an in vitro diagnostic test intended to be used at point-of-care for the detection of influenza A or influenza B in nasal swab samples. The ellume.lab Flu A+B Test generates a result within 10 minutes.
15951981|NCT03248960|Diagnostic Test|Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)|Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) is a molecular diagnostic technique for the detection and identification of influenza viruses, both for clinical samples and isolates. The reverse transcriptase polymerase chain reaction (RT-PCR) allows template viral RNA to be reverse transcribed producing complementary DNA (cDNA) which can then be amplified and detected.
15951982|NCT03248960|Diagnostic Test|Viral culture|Nasopharyngeal samples will be inoculated into appropriate culture media for influenza viral culture. In this test, the virus is actually grown and further identified in the laboratory as influenza A or B.
15951983|NCT03248947|Drug|buprenorphine/naloxone|To relieve opioid withdrawal symptoms and craving, buprenorphine/naloxone will be prescribed by the study-physician and dispensed by the study-pharmacist on a monthly basis. The median expected dose is 16 mg daily, though adjustment by the study physician may be needed due to increased withdrawal and craving from previous study visits. Medication will be provided in the form of a sublingual film.
15951984|NCT03248947|Other|Pharmacist-administered buprenorphine/naloxone maintenance care|Following buprenorphine/naloxone induction/stabilization with the physician, participants with opioid use disorder will be transferred to the care of pharmacists for the maintenance phase of treatment. Maintenance visits will occur monthly with the pharmacist at the pharmacy location for six months. Buprenorphine/naloxone will be dispensed by the pharmacist at the monthly study visits following participant assessment, communication with the physician, and prescription form the physician.
15951985|NCT03248934|Other|Patient Self-Administered Diagnostic Exam|Participants will complete a patient self-administered diagnostic exam. A physician will be available to monitor the patient and record findings but will not physically assist the participants.
15951986|NCT03248934|Other|Clinician-Performed Diagnostic Exam|A clinician-performed diagnostic exam will be completed on the patients.
15951987|NCT03248921|Procedure|cardiac surgery|cardiac surgery including non-emergency, elective coronary artery bypass grafting surgery with or without valve surgery, aortic or mitral valve surgery
15951988|NCT03248908|Diagnostic Test|Pupillary dilation reflex|Perioperative pupillary dilation reflex assessment is executed every 10 minutes from start sedation until extubation in patients allocated to study arm Intervention 1 and Intervention 3
15951989|NCT03248908|Other|Standard of care|Perioperative opioid administration based on the attending anesthesiologist decision (mainly including assessment of heart rate, blood pressure, and limb movement)
15951990|NCT03248895|Device|Mobile Direct Observation of Therapy (MDOT)|Patients who are enrolled in the study will be randomised into two groups (I-med or D-med) to receive Mobile Direct Observation of Therapy (MDOT). Participants or parents/guardians of participants will be asked to capture a DOT video twice daily (morning and evening) on their mobile devices of ICS use by the patient. In the I-med group, participants will be asked to upload daily video recordings via the internet to a repository for a 6 week period at the start of the study. Participants in the D-med group will be free from DOT for the first 6 weeks of the study and will be asked to carry out their usual therapy management. After that, DOT as described above will be applied for the next 6 weeks.
15951991|NCT03248882|Drug|Placebo|Placebo
15951992|NCT03248882|Drug|PF-05221304|PF-05221304, Experimental Drug
15951993|NCT03248869|Other|Current Daily Survey|need description
15951994|NCT03248869|Other|Mobile Health App|Participants recruited, consented and enrolled via the AMHA and complete assessments using the app
15951995|NCT03248856|Drug|Triamcinolone Acetonide|Intratympanic administration
15951996|NCT03248843|Drug|KN035|Four cohorts dosed at 1.0 mg/kg, 2.5 mg/kg, 5.0 mg/kg, and 10 mg/kg weekly. All cohorts are administered by subcutaneous injection (SC).
15951997|NCT03248830|Device|radical-7 pulse co-oximeter|Radical-7 pulse co-oximter will be applied to the patient through a special probe attached the the patient digit to measure blood hemoglobin
15951998|NCT03248817|Drug|single shot phenylephrine|a single shot of phenylephrine (1.5 mcg/Kg) will be administrated intravenously
15951999|NCT03248817|Drug|fixed infusion phenylephrine|fixed infusion of phenylephrine will be administrated at a rate of 0.75 mcg/Kg/min.
15952000|NCT03248817|Drug|variable infusion phenylephrine|Variable infusion of phenylephrine will be administrated at a starting rate of 0.75 mcg/Kg/min.
15952001|NCT03248817|Drug|Bupivacaine|Bupivacaine will be administrated in the subarachnoid space for spinal anesthesia
15952002|NCT03248804|Behavioral|Soy group|
15952003|NCT03248804|Behavioral|Non-soy group|
15952004|NCT03248791|Drug|Phenylephrine|Phenylephrine variable infusion with a starting rate of 0.75 mcg/Kg/min.
15952005|NCT03248791|Drug|Norepinephrine|Norepinephrine variable infusion with a starting rate of 0.1 mcg/Kg/min.
15952006|NCT03248791|Drug|Bupivacaine|Bupivacaine will be injected in the subarachnoid space with a dose of 10 mg
15952007|NCT03248778|Behavioral|disclosure-support counseling intervention|The intervention will include three components: (a) assessment; (b) decision-making and support; and (c) disclosure, planning, and action. The individualized assessment comprehensively will consider the family's history, experiences with disclosure, communication skills, coping resources, and factors likely to affect disclosure (e.g., familial, psychological, social, cultural, and medical issues). The second component of decision-making and support focused on developing communication skills and strategies, with role-play and practice outside of the sessions as necessary. Costs and benefits of disclosure were considered along with the range of disclosure options. Materials, including a pros and cons chart of disclosure and a disclosure continuum worksheet, were used to stimulate discussions of possible plans and consequences. In the third component, parents were encouraged to formulate and practice a disclosure plan for later use.
15952008|NCT03248765|Other|post-surgical opioid use measured at 1 day and 1 week.|"Evaluation of intra-hospital perioperative opioid administration (including intraoperative opioids and Patient Controlled Analgesia (PCA) use). This endpoint is calculated as the total amount of morphine equivalents administered intraoperatively and in the first 24 hours after the end surgery (measured on postoperative day 1).
~2) Opioid utilization after discharge from hospital (prescription refills and pills count at subsequent hospital visits). This endpoint is calculated as the total amount of morphine equivalents consumed in the first week after the surgery (measured at 1 week after surgery by electronic questionnaire and verified by direct pill count performed on occasion of the patient's postsurgical visit )."
15952078|NCT03248245|Other|TAU|Ordinary practices related to interprofessional team collaboration
15952009|NCT03248752|Behavioral|Fitbit use and reports|Participants will receive a Fitbit device to be used for the duration of the study. Participants will engage with the Fitbit and application and receive Weekly Progress Reports from Fitbit.
15952010|NCT03248752|Behavioral|Partner engagement|Participants will be connected with their partner in the Fitbit app and therefore have the ability to access their partner's progress. Participants' Weekly Progress Reports will be automatically forwarded to their partner. Participants will engage in a weekly discussion on the topic of their Weekly Progress Reports.
15952011|NCT03248739|Device|Clear Bactiseal 'large' catheter (EVD)|Antibiotic-impregnated 'large' catheter (inner diameter 1.9 mm, outer diameter 3.4 mm)
15952012|NCT03248739|Device|Orange Bactiseal 'small' catheter (EVD)|Antibiotic-impregnated 'small' catheter (inner diameter 1.5 mm, outer diameter 3 mm)
15952013|NCT03248726|Drug|Polyethylene glycol and bisacodyl|Intervention: Take 3 tablets (15mg) of stimulant laxatives Dulcolax® (bisacodyl) at 10pm the day before examination. Take two pack of osmotic laxative Klean-prep® powder (Polyethylene glycol) mixed with 2000ml water at 5am on the morning of examination.
15952014|NCT03248726|Drug|Split-dose polyethylene glycol|Take two pack of Klean-prep® powder mixed with 2000ml water at 6pm before the day of examination, and take another two pack of osmotic laxative Klean-prep® powder mixed with 2000ml water at 5am on the examination day.
15952015|NCT03248713|Drug|Mifepristone|Mifepristone 600mg 2 tablets will be compared to the placebo
15952016|NCT03248713|Drug|Placebo|Placebo sugar 2 tablets will be compared to mifepristone
15952017|NCT03248700|Other|Vitamin A tracer|A stable isotope tracer of vitamin A was given orally.
15952018|NCT03248687|Other|Follow up|The intervention will be method of follow up.
15952019|NCT03248674|Diagnostic Test|CT FFR|CT FFR calculated the fractional flow reserve based on the data derived for a regular coronary CT angiography. Computation is based on development of an anatomic model of the epicardial coronary arteries for each case and calculating the maximum coronary flow during maximal hyperaemia based on a mathematical model incorporating fluid dynamics. These post-processing steps require quantification of the patient-specific myocardial mass as this allows for an estimation of the baseline coronary blood flow.
15952020|NCT03248661|Behavioral|Now I'm Telling You|Messages will be sent trough Facebook, Twitter, Instagram, e-mail, texting or other electronic/social media specified by study volunteers.
15952021|NCT03248648|Drug|Neostigmine|patient receive 0.5mg/dose neostigmine +18ml 0.25%bupivacaine in a total volume of 20 ml.
15952022|NCT03248648|Drug|ketamine|patient receive 0.5 mg/kg ketamine+18ml 0.25%bupivacaine in a total volume of 20 ml.
15952023|NCT03248609|Other|Milano grapes|Milano grapes to test post-prandial glycemic response
15952024|NCT03248609|Other|Table grapes|Table grapes to test post-prandial glycemic response
15952025|NCT03248609|Other|Grape juice|Grape juice to test post-prandial glycemic response
15952026|NCT03248609|Other|Glucose beverage|Standardized glucose beverage to test post-prandial glycemic response
15952027|NCT03248583|Other|Default option|"The default option is a behavioral economics construct that refers to the option a consumer selects if no active choice is made (e.g. opt-out 401K plans, which significantly increase enrollment, compared to active sign up).
~Participants in the default condition were presented with a pre-filled online shopping cart containing a combination of groceries that meet macro- and micronutrient requirements for their gender and age, and told that they are free to delete, add, and exchange any item they wish to finalize their selections."
15952028|NCT03248583|Other|Psychoeducation|"Participants in the psychoeducation condition were instructed to read a brief psychoeducational brochure adapted from materials currently utilized by the New York State Office of Temporary and Disability Assistance (Eat Smart New York)."
15952029|NCT03248583|Other|Incentive|Participants in the incentive condition were informed that they will receive a gift card to a major retailer of their choice if they select groceries that meet recommended nutritional guidelines for macro- and micronutrient requirements. Participants were given examples of macro- and micronutrients to ensure that the instructions were clear.
15952030|NCT03248570|Drug|Pembrolizumab|All subjects will receive pembrolizumab 200mg IV every 3 weeks until disease progression or unacceptable toxicity.
15952031|NCT03248570|Drug|Chemotherapy|At time of progression, all subjects will also have the option of receiving taxane-based chemotherapy followed by repeat pembrolizumab for those who have a clinical response to chemotherapy. Chemotherapy regimen will be at the discretion of the treating physician, and may consist of docetaxel or cabazitaxel with or without a platinum agent (e.g. carboplatin). A minimum of 4 cycles and a maximum of 8 cycles of chemotherapy will be given.
15952032|NCT03248557|Diagnostic Test|Spectral analysis of ventricular fibrillation tracings|Up to 5-s long ventricular fibrillation segments will be extracted after segmentation and signal codification from artifact-free tracings. Signals will be band-pass filtered between 1.5 and 40 Hz. Averaged power spectral density will be obtained at each frequency using the non-parametric Welch method for using fast Fourier transform and normalized to the peak power in the 1.5-10 Hz band for each patient. Dominant frequency, HL-PSDR (the relative power between high and low frequency bands (cut-off: 3.9 Hz)) and HL-pKR ( relative number of spectral peaks above and below the 3.9 Hz threshold with power above 40% the frequency with the highest power), along with the number of DC shocks before ROSC, will be the variables used to obtain a model-derived risk score for outcome prediction.
15952033|NCT03248544|Drug|vitamin D|Fat-soluble vitamin D injection contain of 300,000 IU vitamin D that given via intramuscular injection
15952034|NCT03248544|Other|control|No intervention
15952035|NCT03248531|Drug|Bimekizumab|Bimekizumab in different dosages (dose 1 and 2).
15952036|NCT03248531|Drug|Adalimumab|Adalimumab in different dosages (dose 1, 2 and 3).
15952037|NCT03248531|Other|Placebo|Placebo will be provided matching Bimekizumab.
15952038|NCT03248518|Behavioral|Usual Care|Information booklet on fatigue which represents usual care in almost all UK rheumatology centres
15952039|NCT03248518|Behavioral|Cognitive behavioural approach|A talking therapy which explicitly aims to replace unhelpful beliefs and behaviours through the application of patient-centred strategies and behavioural activities
15952040|NCT03248518|Behavioral|Personalised Exercise Programme|PEP is a graded exposure behaviour therapy which aims to gradually optimise patients levels of physical activity with view to modifying their altered perception of effort and ultimately reduce the severity and impact of fatigue.
15984810|NCT03002090|Dietary Supplement|Placebo Untrained|No intervention
15952041|NCT03248505|Device|Conventional TENS|Transcutaneous Electrical Nerve Stimulation (frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude) with two electrodes in each side of the lumbar spinal.
15952042|NCT03248505|Device|Burst TENS|Burst-modulated TENS with carrier frequency of 100 Hz, burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude.
15952043|NCT03248505|Other|Cryotherapy|1,5 Kg of crushed ice pack on lumbar spine.
15952044|NCT03248505|Device|Burst TENS + Cryotherapy|Burst-modulated TENS with carrier frequency of 100 Hz, burst-modulated at 4Hz, pulse duration of 200 micro-seconds and motor-level amplitude plus 1,5 Kg of crushed ice pack on lumbar spine.
15952045|NCT03248505|Device|Conventional TENS + Cryotherapy|Transcutaneous Electrical Nerve Stimulation (frequency of 100 Hz, pulse duration of 100 micro-seconds and sensory-level amplitude) plus s 1,5 Kg of crushed ice pack on lumbar spine.
15952046|NCT03248505|Other|Placebo TENS|TENS device turned on, but with zero amplitude.
15952048|NCT03248479|Drug|Magrolimab|Administered intravenously
15952049|NCT03248479|Drug|Azacitidine|Administered according to region-specific drug labeling either subcutaneously or intravenously
15952050|NCT03248466|Biological|PRG combined with BMMSCs transplantation|PRG combined with BMMSCs transplantation
15952051|NCT03248453|Other|CoPS|The COPS is an automated and objective computer-based program which generate a score/number after the colonoscope has reached the cecum. The participants are able to compare the score with experts.
15952052|NCT03248440|Drug|SUN-131 1.5% TDS|SUN-131 1.5% TDS will be worn for 14 days
15952053|NCT03248440|Drug|Placebo TDS|No active substance; Placebo TDS will be worn each day for 14 days
15952054|NCT03248427|Drug|Ribociclib|Ribociclib flat-fixed dose of 600 mg daily (three 200-mg capsules), days 1 to 21 of a 28-days cycle.
15952055|NCT03248427|Drug|Letrozole 2.5mg|Daily continuous
15952056|NCT03248427|Drug|Doxorubicin|60 mg/m2 as a continuous IV perfusion
15952057|NCT03248427|Drug|Cyclophosphamide|600 MG/M2 in a 30 minutes IV infusion
15952058|NCT03248427|Drug|Paclitaxel|80 mg/m2, in one hour IV infusion
15952059|NCT03248414|Dietary Supplement|Lactobacillus sakei|1 pack contained 5 x 109 cfu
15952060|NCT03248401|Drug|Cilostazol|Cilostazol 200 mg/day
15952061|NCT03248401|Drug|Aspirin|Aspirin 100 mg/day
15952062|NCT03248388|Device|Argus II Eyeglasses|The Argus II Eyeglasses (retinal prosthesis) can restore rudimentary forms of vision to patients with bare light-perception vision. Using the prosthesis, patients can identify obstacles, handles, switches, eating utensils and demonstrate improved navigation when used in conjunction with other ambulation-assist tools. Current limits in the resolution of the device prevent useful reading or face recognition.
15952063|NCT03248388|Device|ORCAM|ORCAM is a commercially-available eyeglass-mounted visual pattern recognition system capable of converting photographs of text to speech. It is comprised of a camera, a small belt-worn computer, pattern recognition software and a small audio transducer. ORCAM can acquire the image of a sheet of paper and read the text to the user through a small speaker adjacent to the ear. In addition, ORCAM can be trained to recognize faces and speak the name of the individual to the user. ORCAM can also be used to recognize everyday products after being programmed.
15952064|NCT03248375|Radiation|Radiation Segmentectomy|The administration of radioactivity in a branch of an artery of the liver
15952065|NCT03248362|Device|Transcutaneous posterior tibial nerve stimulation|12 session programme (a total of 6 hours) is delivered in 30 minute sessions twice weekly over a 6 week period of tibial nerve stimulation
15952066|NCT03248362|Device|Sham stimulation|12 session programme (a total of 6 hours) is delivered in 30 minute sessions twice weekly over a 6 week period of of the lateral sub-malleolar area
15952067|NCT03248349|Drug|Pharmacokinetics|"Blood samples are drawn for pharmacokinetic properties of antibiotics during routine care treatment
~Blood samples for relevant covariates of drug disposition (kidney function, liver enzymes, C-reactive protein (CRP), albumin)
~Whole blood is stored for DNA analysis
~Urine is drawn from catheter for more detailed estimation of glomerular filtration rate and drug metabolite analysis"
15952068|NCT03248336|Procedure|office-based vergence/accommodative therapy|one -to-one treatment by a trained therapists. The subject is asked to perform 5-6 therapy procedures during a 60 minute therapy session. The subject is also asked to perform 15 minutes per day of home-based therapy.
15952069|NCT03248323|Radiation|dyna-pbv|
15952070|NCT03248310|Behavioral|Quality of Life Assessments|Upper Limb Lymphedema (ULL-27), Lymphedema Life Impact Scale, version 2 (LLISv2), LYMQOL-Leg.
15952071|NCT03248297|Drug|Azithromycin|Azithromycin tablet
15952072|NCT03248297|Drug|Azithromycin and amoxicillin|azithromycin and amoxicillin
15952073|NCT03248297|Drug|Placebo|Placebo tablet
15952074|NCT03248284|Procedure|Tendon biopsy procedure|Two tendon biopsy specimens will be obtained from one Achilles tendon with enthesitis.
15952075|NCT03248271|Drug|Insulin Lispro|Insulin
15952076|NCT03248258|Other|Qualitative Interview or Focus group discussions|"The purpose of this study is to identify factors that influence decision-making in treatment selection and the optimal approach for sharing information about prognosis and guideline-based care.
~Secondly, to further understand patient perspective on the concept of de-escalation, in which patients reduce the amount of chemotherapy to avoid side effects and (2) consider how prognosis would impact their decision-making about reducing chemotherapy (as standard or care or within a clinical trial)."
15952077|NCT03248245|Other|LOG-model|"Besides the LOG-manual, school owners and leaders receive economic compensation and the intervention team will supervise the implementation. School-owners, school leaders and teachers will participate in dialogue-seminars at the municipal level and the school level respectively. The aim is to discuss and agree on the goal and content of the work and discuss the experiences from the implementation. The main arena for discussing and practical implementation will be in local collaborating teams or resource teams in each school. The resource teams at schools will consist of various interprofessional competences in addition to the school leader. The main method in the LOG-model is the interchange and feedback process between the discussion of measures and the execution of these measures."
15985624|NCT02995863|Device|Rigid Rocker Sole Footwear|
15952079|NCT03248206|Behavioral|lifestyle changes|Providing a home-based exercise program supervised by therapists can be an acceptable strategy with the characteristics of convenience and inexpensiveness to promote neuromuscular and functional component for the patients with diabetes mellitus.
15952080|NCT03248193|Device|Concomitant limb cryocompression and scalp cooling|"Part 1: Establishing optimal temperature for hypothermia therapy. Healthy subjects will undergo 3 hours of cryocompression various temperature levels.
~Part 2: Establishing optimal pressure for hypothermia therapy. Each subject will undergo cryocompression (fixed at the lowest tolerated temperature established in Section 1) over 3 hours. The pressure ranges to be tested are either low, medium, or high.
~Part 3: Establishing safety and tolerability of scalp hypothermia. Scalp hypothermia will be administered over 3 hours using the cooling cap attached to the cooling device.
~Part 4: Establishing safety and tolerability of concomitant therapy. Subjects will undergo simultaneous scalp hypothermia and four-limb cryocompression at the temperature and pressure established in Sections 1 and 2. The concomitant therapy will be administered over 3 hours."
15952081|NCT03248193|Device|Concomitant limb cryocompression and scalp cooling|"The study population will comprise of cancer patients scheduled to receive weekly paclitaxel chemotherapy for a maximum of 12 cycles.
~Paclitaxel will be administered as a one-hour infusion. Concomitant scalp cooling and limb cryocompression sessions comprised of a pre-cooling period (one hour), continued with paclitaxel infusion and a post-cooling period (on average 30 minutes after the end of paclitaxel infusion). Overall, hypothermia will be administered for no longer than four hours.
~Cryocompression will be administered on patients based on the lowest tolerated temperature and optimal pressure as determined in healthy subjects."
15952082|NCT03248167|Drug|Cannabidiol|600 mg daily
15952083|NCT03248167|Drug|Placebos|This project aims to determine whether cannabidiol (CBD) is effective in treating alcohol use disorder (AUD) comorbid posttraumatic stress disorder (PTSD). To address this aim, investigators will conduct a clinical trial in which CBD will be adminstred to 48 individuals with AUD comorbid with PTSD, and assess alcohol intake and PTSD symptoms. The aim is to test the hypothesis that CBD will reduce alcohol drinking in individuals with AUD comorbid with PTSD. To test this hypothesis, 48 otherwise healthy adult participants with moderate or severe AUD and PTSD will be randomized to treatment with either CBD (600 mg daily) or placebo, for a period of 6 weeks, such that both participants and study staff are blind to treatment condition.
15952084|NCT03248154|Device|Procellera|burn dressing
15952085|NCT03248141|Drug|Hemophilia B standard half-life|Benefix
15952086|NCT03248141|Drug|Hemophilia B extended half-life|Alprolix
15952087|NCT03248141|Drug|Hemophilia A standard half-life|Xyntha and other standard half-life agents
15952088|NCT03248141|Drug|Hemophilia A extended half-life|Eloctate and Adynovate
15952089|NCT03248128|Drug|FF/VI via ELLIPTA DPI|ELLIPTA DPI inhaler will contain two individual blister strips; the first strip will contain FF(50 or 100 mcg) and second strip will contain VI (25 mcg).
15952090|NCT03248128|Drug|FF via ELLIPTA DPI|ELLIPTA DPI inhaler will contain a single blister strip of FF (50 or 100 mcg).
15952091|NCT03248115|Dietary Supplement|Green tea and green coffee extract tablets|"Tablets: participants were required to take 6 green tea and 3 green coffee extract tablets daily for a period of 8 weeks. No tablets were taken during the last 4 weeks of the study. Randomly chosen tablets were analysed to quantify their polyphenol content.
~Urine collections: Several urine collections were required during the supplementation period in order have sufficient time points to estimate the plateau of the concentration of green tea and coffee polyphenols excreted in the urine to then be able to determine their bioavailability. There was a total of five 24-hour urine collections (at week 0 -before supplementation-, 2, 4, 8, and 12 -4 weeks after finishing the supplementation period).
~Completion of study documents: Participants were provided with urine collection sheets, polyphenol questionnaires, checklists to record polyphenol tablet intake, and detailed instructions."
15952092|NCT03248102|Diagnostic Test|Blowing into the mouthpiece|Blowing into the mouthpiece of diagnostic device
15952093|NCT03248089|Diagnostic Test|Guardant360|Cell-free circulating tumor DNA (cfDNA) targeted next-generation sequencing (NGS) panel.
15952094|NCT03248076|Drug|Fentanyl Citrate|1γ/Kg fentanyl
15952095|NCT03248063|Drug|Cloxacillin|"Intravenous treatment by cloxacillin, 25 to 50 mg/kg every 4 or 6 hours, without doing less than the minimum daily dose of 8 g/day and without exceeding the maximum daily dose of 12 g/day, administered as a 60-minutes infusion. This treatment will be administered for at least 7 days by intravenous route.
~Dosing regimen will be adapted in patients with chronic renal failure (glomerular filtration rate below 30ml/min/1.73m²) and in patient with impaired hepatic function associated with renal impairment whatever the level of the estimation of the glomerular filtration rate, according to SPC."
15952096|NCT03248063|Drug|Cefazolin|Intravenous treatment by cefazolin, 25 to 50 mg/kg every 8 hours (without exceeding the maximum daily dose of 6 g/day), administered as a 30-minutes infusion. This treatment will be administered for 14 days by intravenous route. Dosing regimen will be adapted in case of glomerular filtration rate between 30-50ml/min according to SPC. As currently recommended, investigators will be encouraged to use the intravenous route for the entire duration of treatment. However, in order to interfere as little as possible with usual practice in each center, the antimicrobial therapy will be let to the choice of the physician in charge of the patient after a minimum of 7 days of intravenous treatment.
15952097|NCT03248050|Behavioral|Pharmacy encouraged to promote call centre use to clients|The details of the intervention will be finalised following an intervention design workshop. The main components will be: Provision of materials with the MSZ call centre number on for pharmacy workers to give women buying MA medications to call the number for free, confidential advice on how to use the pills before they take them; incentives; monthly monitoring visits.
15952098|NCT03248037|Drug|Netarsudil|netarsudil opthalmic solution 0.02%
15952099|NCT03248037|Drug|Placebo|Placebo eye drops
15952100|NCT03248011|Other|Stretching|Lower extremity flexibility exercises will be performed
15952101|NCT03248011|Other|Strengthening|Eccentric hamstring strengthening exercises will be performed
15952102|NCT03248011|Other|Neuromuscular|Dynamic lower extremity balance and movement control exercises will be performed
15952137|NCT03247725|Other|pain app|Pain Monitor app has been developed by a multidisciplinary pain expert panel, including physicians, psychologists, and nurses. Content has been validated in a previous study and usability has been shown to be excellent.
15952138|NCT03247725|Other|Treatment as usual (medical)|Patients will be offered the usual treatment for their pain, which is not changed by study participation
15952103|NCT03247998|Drug|General Anesthesia|Patients who have had a stroke and meet the inclusion criteria for the study will receive general anesthesia during endovascular treatment. Choice of anesthetic for general anesthesia is dependent upon the patient condition and decision of the treating anesthesiologist (ketamine, propofol, fentanyl, midazolam,dexmedetomidine etc.). Induction of general anesthesia will follow standard treatment methods (Davis et al, 2012, Powers et al. 2015 Talke et al. 2015). Patient monitoring and care will proceed in accordance with standard of care guidelines. Refer to Detailed Description section for complete protocol information.
15952104|NCT03247998|Drug|Conscious Sedation with Remifentanil|Patients who have had a stroke and meet the inclusion criteria for the study will receive conscious during endovascular treatment. Sedation will be accomplished using Remifentanil: 0.01-0.06 micrograms/kilogram/minute, titrated to effect. (Janssen et al., 2016). Patient monitoring and care will proceed in accordance with standard of care guidelines. Refer to Detailed Description section for complete protocol information.
15952105|NCT03247985|Device|PROLENE Polypropylene Tacking Mesh|Prolene mesh is a polypropylene plastic mesh (10 x 15 cm) implant fixed with titanium tacks
15952106|NCT03247985|Device|ProGrip Self-fixating Mesh|"ProGrip™ self-fixating mesh is a tack-free fixation mesh for use in open & laparoscopic hernia repairs. It is composed of absorbable Monofilament Polylactic Acid micro grips on one surface integrated with a lightweight Monofilament Polyethylene Terephthalate. The micro grips act as a kind of Velcro to the soft tissue surfaces resulting in self-fixation"
15952107|NCT03247972|Drug|Evolocumab|Sixty subjects will be treated with high dose statins for 8 weeks followed by 8 weeks of high dose statin + evolocumab (420mg/4 wk) therapy.
15952108|NCT03247959|Behavioral|Video game distraction and video distraction|video game distraction and video distraction will be advocated during the extraction procedure
15952109|NCT03247946|Behavioral|upright head position|Bottle feeding of infants with their head in upward and not supine head position
15952110|NCT03247933|Device|Telemedicine: Maintenance Respiratory Rehabilitation|"Telemedicine: Maintenance Respiratory Rehabilitation. Patients will receive a personal program of maintenance respiratory rehabilitation supported by telemedicine (TeleRR).
~A personal program of Respiratory rehabilitation consists on: 20-30 minutes of static bicycle exercises + 3 series of ten repetitions from 4 different types of exercises with weights / cufflinks. 3 days a week, every week for a year.
~They will be in their homes doing the program of treatment prescribed by the physician. They will be provided with the material that is needed: 1 static bicycle, 2-weights / cufflinks, 3-device mobile (smartphone/PDA) + Pulse Oximeter.
~The patient must send the exercises every day that are scheduled training exercises once have been completed."
15952111|NCT03247920|Drug|Amoxicillin Clavulanate|Dose 75 mg/kg/day, (3dd 25 mg/kg). Concentration amoxicillin/clavulanic acid: 4:1
15952112|NCT03247920|Drug|Antibiotics|Intravenous antibiotic therapy following local protocol
15952113|NCT03247907|Device|Condition A: CPAP with No Humidification|CPAP with No Humidification with no mouth leak
15952114|NCT03247907|Device|Condition B: CPAP with No Humidification|CPAP with No Humidification with mouth leak
15952115|NCT03247907|Device|Condition C: CPAP with Cold Passover|CPAP with Cold Passover with mouth leak
15952116|NCT03247907|Device|Condition D: CPAP with Modified humidifier|CPAP with Modified humidifier with mouth leak
15952117|NCT03247907|Device|Condition E: CPAP with Ambient Tracking|CPAP with Ambient Tracking with mouth leak
15952118|NCT03247907|Device|Condition F: CPAP with Heated Humidification|CPAP with Heated Humidification at default setting with mouth leak
15952119|NCT03247907|Device|Condition G: CPAP with Heated Humidification|CPAP with Heated Humidification at max setting with mouth leak
15952120|NCT03247907|Device|Condition H: CPAP with New level humidification|CPAP with New level humidification with mouth leak
15952121|NCT03247894|Other|Data search|Patients data were searched for the patients with MS, who laboured in tertiary perinatology center in the study period
15952122|NCT03247881|Other|Nut Free Diet|Participants will consume whatever they like, as much as they like, from a pre-determined buffet with 0 g/d of mixed nuts.
15952123|NCT03247881|Other|Added Mixed Nuts Diet|Participants will consume whatever they like, as much as they like, from a pre-determined buffet which will include 2 servings (2 ounces) of mixed nuts per day (1 serving just prior to breakfast and 1 serving as an afternoon snack).
15952124|NCT03247868|Combination Product|Botulinum Toxin+SPRInt|Botulinum toxin injections in association with rehabilitative approach to cervical dystonia (SPRInt)
15952125|NCT03247855|Procedure|minimal invasive coronary artery bypass graft surgery|coronary artery bypass grafting surgery by using a minimal invasive technique
15952126|NCT03247842|Procedure|suprascapular nerve block|Sixty patients with shoulder dystocia after breast surgery will receive stellate ganglion neurolysis with supra-scapular nerve radiofrequency,
15952127|NCT03247829|Device|Hemodynamic management using CardioMEMS|Using the CardioMEMS HF system, clinicians will treat to target PA pressure ranges
15952128|NCT03247803|Device|air-Q® SP|air-Q SP placement for airway maintenance,
15952129|NCT03247803|Device|Williams Airway Intubator (WA)|WA is placed in subject's oropharynx. If the vocal cords are not in view at the end of the WA, the operator may ask an assistant to perform an airway maneuver (e.g., jaw thrust, anterior jaw lift, or lingual traction) to attempt to bring the vocal cords into view
15952130|NCT03247790|Drug|Lasmiditan|Administered orally
15952131|NCT03247777|Other|Traditional strengthening|dead lifts, bench press, wrist curls, and lat pulldowns as examples
15952132|NCT03247777|Other|Functional Strengthening|diagonal chops, one leg deadlifts, lateral plyometrics as examples
15952133|NCT03247764|Drug|SSRIs or xylaria nigripes|Patients with comorbidity of epilepsy and depression will be used SSRIs or xylaria nigripes as antidepressants after discussing with them. They will still be followed up if they don't want to use any antidepressants.
15952134|NCT03247751|Device|intraocular lens|Implant NIDEK intraocular lens after cataract surgery
15952135|NCT03247738|Drug|Cangrelor|Patients will be randomly assigned 1:1 to receive either cangrelor or matching placebo. The bolus will be administered at the same time of a 180 mg crushed ticagrelor loading dose and infusion will be continued for 2 h.
15952136|NCT03247738|Other|Placebo|Patients will be randomly assigned 1:1 to receive either cangrelor or matching placebo. The bolus will be administered at the same time of a 180 mg crushed ticagrelor loading dose and infusion will be continued for 2 h.
15952139|NCT03247712|Drug|Nivolumab|Nivolumab 240mg IV q2wks or 480mg IV q4wks
15952142|NCT03247712|Radiation|Radiation (3 days)|8Gy x 3 (Monday, Wednesday, Friday) GTV+3mm
15952143|NCT03247699|Other|"Basel phenotyping cocktail capsule"|"Oral intake of Basel phenotyping cocktail capsule and pharmacokinetics (PK) sampling"
15952144|NCT03247699|Other|"Basel phenotyping cocktail individual components"|"Oral intake of Basel phenotyping cocktail individual components and PK sampling"
15952145|NCT03247686|Drug|RSLV-132|RNase Fc fusion protein
15952146|NCT03247686|Drug|Placebo|Placebo
15952147|NCT03247673|Drug|CT-P16|CT-P16 is a biosimilar product for Avastin
15952148|NCT03247673|Drug|EU-approved Avastin|EU-approved Avastin
15952149|NCT03247673|Drug|US-licensed Avastin|US-licensed Avastin
15952150|NCT03247660|Other|PFM training|See information included in arm/group descriptions.
15952151|NCT03247660|Other|HE|See information included in arm/group descriptions.
15952152|NCT03247660|Behavioral|Educational strategy|See information included in arm/group descriptions.
15952153|NCT03247647|Behavioral|Enhanced Intervention|Participants will complete a personal values task immediately before viewing feedback from eCheckUpToGo.
15952154|NCT03247647|Behavioral|Standard Intervention|Participants will write about the food they have eaten in the last 48 hours.
15952155|NCT03247634|Behavioral|Getting Ahead in a Just-Gettin'-By World|The Getting Ahead program is a unique welldeveloped program that allows carefully guided introspection toward the crafting of tailored solutions aimed at addressing complex social determinants of health among individuals living in vulnerable populations where the achievement of health equity often seems unattainable. The important lens of health equity is a key component of this proposal and is consistent with the American Cancer Society overarching emphasis on reduction of health disparities and achievement of health equity.
15952156|NCT03247621|Behavioral|Whatsapp|
15952157|NCT03247621|Behavioral|Article|
15952158|NCT03247621|Behavioral|No Phone|
15952159|NCT03247608|Behavioral|Ambio Health Remote Monitoring|Participants in the Connected Heart Health study will complete a 24 week CarePlan including education, biometric monitoring, and communication with the health care team members. Each day the participant will receive an email from Ambio Health with a daily task list that includes a variety of activities. These tasks include uploading biometrics (weight and blood pressure), completing assessment on self-management skills (nutrition, physical activity, and medication management), accessing educational content (videos, web links, interactive quizzes), participation in challenges, and communicating with the care team and care givers.
15952160|NCT03247595|Dietary Supplement|Magnesium Citrate Capsules|36 magnesium citrate gelatin capsules
15952161|NCT03247595|Other|Polyethylene Glycol 3350|4 liters of Polyethylene Glycol for colonoscopy preparation
15952162|NCT03247595|Other|Dulcolax Tablets|4 Dulcolox Tablets
15952163|NCT03247582|Drug|Edoxaban|Edoxaban according to Package Information (Summary of Product Characteristics (SmPC)).
15952164|NCT03247569|Drug|Edoxaban|Edoxaban according to Package Information (Summary of Product Characteristics (SmPC)).
15952165|NCT03247556|Drug|Placebo|Placebo was administered once daily
15952166|NCT03247556|Drug|400mg SPN-812|400mg SPN-812 was administered once daily and compared to Placebo
15952167|NCT03247556|Drug|600mg SPN-812|600mg SPN-812 was administered once daily and compared to Placebo
15952168|NCT03247543|Drug|Placebo|Placebo was administered once daily
15952169|NCT03247543|Drug|200mg SPN-812|200mg SPN-812 was administered once daily and compared to placebo
15952170|NCT03247543|Drug|400mg SPN-812|400mg SPN-812 was administered once daily and compared to placebo
15952171|NCT03247530|Drug|Placebo|Placebo was administered once daily
15952172|NCT03247530|Drug|100mg SPN-812|100mg SPN-812 was administered once daily and compared to placebo
15952173|NCT03247530|Drug|200mg SPN-812|200mg SPN-812 was administered once daily and compared to placebo
15952174|NCT03247517|Drug|Placebo|Placebo was administered once daily
15952175|NCT03247517|Drug|200mg SPN-812|200mg SPN-812 was administered once daily and compared to placebo
15952176|NCT03247517|Drug|400mg SPN-812|400mg SPN-812 was administered once daily and compared to placebo
15952177|NCT03247491|Behavioral|Mindfulness|TAU + mindfulness applied face to face 8 sessions of 120 minutes/session Mindfulness and Compassion based intervention applied in groups of 12-15 people in traditional format. Written material and sound recordings will be offered as support elements. The estimated duration of the face to face program is two months.
15952178|NCT03247465|Other|Image Fusion|Addition of computed tomography 3D images and calcification raising to the usual fluoroscopy images.
15952179|NCT03247452|Other|One-day Low fiber diet|One-day low fiber diet before colonoscopy
15952180|NCT03247452|Other|Three-day low fiber diet|Three days low fiber diet before colonoscopy
15952181|NCT03247452|Drug|Polyethylene Glycol plus ascorbic acid|2 liters of Polyethylene Glycol plus ascorbic acid will be administered to both groups
15952182|NCT03247439|Device|Cartiva|Synthetic Cartilage Implant
15952183|NCT03247426|Other|Evaluation individuals|Sleep quality of the individuals, job satisfaction, quality of life, occupational burnout level will be evaluated.
15952184|NCT03247413|Drug|Dexamethasone 4 mg/ml|dexamethasone 4 milligram given post-ablation at each lesion site
15952185|NCT03247413|Drug|Normal saline|Placebo, normal saline administered post-ablation at each lesion site
15952186|NCT03247400|Drug|1% simvastatin-acid sodium salt ointment|1% simvastatin-acid sodium salt ointment applied onto a predefined limb
15952187|NCT03247400|Drug|1% atorvastatin calcium salt ointment|1% atorvastatin calcium salt ointment applied onto a predefined limb
15952188|NCT03247387|Device|MC10 BioStampRC|"Subjects will fill out electronic diaries on a provisioned iPhone to capture On versus Off time on a daily basis while at home. In addition, subjects will be asked to wear three actigraphy devices."
15952189|NCT03247387|Device|APDM actigraphy device|"Subjects will fill out electronic diaries on a provisioned iPhone to capture On versus Off time on a daily basis while at home. In addition, subjects will be asked to wear three actigraphy devices."
15952190|NCT03247387|Device|GENEActiv watch|"Subjects will fill out electronic diaries on a provisioned iPhone to capture On versus Off time on a daily basis while at home. In addition, subjects will be asked to wear three actigraphy devices."
15952218|NCT03247153|Diagnostic Test|Echocardiography|Imaging of the heart using ultrasound
15952191|NCT03247374|Device|"ProComp5 Infiniti Biofeedback"|"Each participant will attend 5 sessions per week for a total duration of 5 weeks. At the beginning of the bio-feedback session, a surface electrode will be applied to the mylohyoid muscle. The computer will produce visual feedback of the muscular activity on the screen. The patient will be required to swallow at a given time, with food bolus if possible, and perform maneuvers that favour swallowing strength and efficacy: they are requested to do classical maneuvers that favour swallowing efficacy that is effortful swallow, supraglottic swallow, and Masako maneuver. The experimental group will perform this training for 45 minutes."
15952192|NCT03247374|Other|Standard Speech and Language Therapy|"Each participant will attend 5 sessions per week for a total duration of 5 weeks. The patient will be required to swallow at a given time, with food bolus if possible, and perform maneuvers that favour swallowing strength and efficacy receiving verbal feedback from the speech and language therapist. They are requested to do classical maneuvers that favour swallowing efficacy that is effortful swallow, supraglottic swallow, and Masako maneuver. The control group will perform this training for 45 minutes."
15952193|NCT03247361|Other|High-intensity IMT + Aerobic/resistance exercise|High-intensity IMT
15952194|NCT03247361|Other|Low-intensity IMT + Aerobic/resistance exercise|Low-intensity IMT
15952195|NCT03247361|Other|Sham IMT + Aerobic/resistance exercise|Aerobic and resistance exercise
15952196|NCT03247348|Behavioral|ReSeT-FM intervention|The ReSeT-FM intervention focuses on behavior changes strategies aimed at reducing sedentary time and includes: education, goal setting, self-monitoring of behavior and behavioral prompts to move via an activity tracker and phone app, and feedback on behavior via weekly meetings with study coaches.
15952197|NCT03247322|Other|Pharmacist-led medication therapy using mHealth application|This cohort of participants will receive clinical pharmacist-led supplemental medication therapy monitoring and management, utilizing a smartphone-enabled mHealth application, integrated with televisits and home-based monitoring of blood pressures and glucoses (when applicable).
15952198|NCT03247309|Biological|IMA201 Product|The cell dose will be based on viable CD3+CD8+ HLA-Dextramer+ cells per body surface area (BSA) as defined by the Mosteller formula.
15952199|NCT03247309|Diagnostic Test|IMADetect®|IMADetect® is developed as a companion diagnostic to aid in selecting patients with relapsed and/or refractory solid cancers who might be eligible for enrollment in clinical trials with investigational IMA201 therapy. IMADetect® is intended for investigational use only.
15952200|NCT03247296|Drug|Sofosbuvir 400 mg, Daclatasvir, Ribavirin|No intervention made this is an observational study to monitor the already existing protocols of the facility
15952201|NCT03247283|Drug|BMS-986205|Carbon 14 tagged BMS-986205
15952202|NCT03247270|Behavioral|Intervention I|Low intensive physical exercise
15952203|NCT03247270|Behavioral|Intervention II|High intensive physical exercise
15952204|NCT03247257|Procedure|General Anesthesia|Patients will be put under general anesthesia for cholecystectomy
15952205|NCT03247257|Procedure|Epidural Anesthesia|Patients will receive Epidural Anesthesia for cholecystectomy
15952206|NCT03247244|Drug|Cannabis|THC 10%, CBD <0.5%
15952207|NCT03247244|Drug|Cannabis|THC 8.6%, CBD 8.6%
15952208|NCT03247244|Drug|Cannabis|THC 0.6%, CBD 14%
15952209|NCT03247231|Device|Endoscopic band ligation without resection|Endoscopic treatment of subepithelial tumors: autoamputation by endoscopic band ligation without resection.
15952210|NCT03247231|Procedure|SINK|To obtain sample tissue biopsies after the endoscopic band ligation without resection, performing a single-incision with a needle-knife.
15952211|NCT03247218|Drug|Memantine Hydrochloride|a low-moderate affinity, uncompetitive, NMDAR antagonist
15952212|NCT03247205|Behavioral|HipERS|This is a graduated, functionally-based exercise intervention conducted in the participant's home. The intervention incorporates verbal encouragement and positive reinforcement, role modeling, assessment of and elimination of unpleasant sensations associated with an activity, and confidence building through activity repetition. The exercise component includes 1) strengthening exercises, 2) range of motion exercises, 3) balance training, 4) functional training, such as chair rising, ambulation training, and stair climbing, 5) transfer practice, 6) adjusting walking aides, and 7) adapting and modifying environment; with a focus on lower extremity tasks in all these areas.
15952213|NCT03247192|Dietary Supplement|Whey protein-placebo|This investigation was carried out over a period of 26 weeks divided in two phases. The first phase of the study was an eight-week period (weeks 3-10), during which subjects were familiarized to RT. Phase 2, supplementation phase, the participants was randomized in three groups and started 12 weeks dedicated to supplementation plus RT (weeks 13-24). At the beginning and the end of each phase of the experiment, two weeks were allocated for evaluations (weeks 1-2, 11-12 and 25-26) consisting of anthropometric, body composition, blood samples, blood pressure, one repetition maximum tests (1RM) and dietary intake measurements
15952214|NCT03247192|Dietary Supplement|Placebo-whey protein|This investigation was carried out over a period of 26 weeks divided in two phases. The first phase of the study was an eight-week period (weeks 3-10), during which subjects were familiarized to RT. Phase 2, supplementation phase, the participants was randomized in three groups and started 12 weeks dedicated to supplementation plus RT (weeks 13-24). At the beginning and the end of each phase of the experiment, two weeks were allocated for evaluations (weeks 1-2, 11-12 and 25-26) consisting of anthropometric, body composition, blood samples, blood pressure, one repetition maximum tests (1RM) and dietary intake measurements
15952215|NCT03247192|Dietary Supplement|Placebo-placebo|This investigation was carried out over a period of 26 weeks divided in two phases. The first phase of the study was an eight-week period (weeks 3-10), during which subjects were familiarized to RT. Phase 2, supplementation phase, the participants was randomized in three groups and started 12 weeks dedicated to supplementation plus RT (weeks 13-24). At the beginning and the end of each phase of the experiment, two weeks were allocated for evaluations (weeks 1-2, 11-12 and 25-26) consisting of anthropometric, body composition, blood samples, blood pressure, one repetition maximum tests (1RM) and dietary intake measurements
15952216|NCT03247179|Other|PTSD Coach mobile application|The PTSD Coach app is publicly available for free, and draws on cognitive behavioral therapy components to help participants learn, manage, and cope with their PTSD symptoms in real time.
15952217|NCT03247166|Device|TOPS™ System|The TOPS™ System is an alternative to spinal fusion that is designed to stabilize but not fuse the effected vertebrai level to alleviate pain stemming from degenerative joints
15985625|NCT02995863|Device|Therapeutic Footwear|
15952219|NCT03247140|Drug|JLP-1401|Administration of JLP-1401(Telmisartan/Amlodipine/Rosuvastatin)
15952220|NCT03247140|Drug|Telmisartan/Amlodipine, Rosuvastatin|Administration of Temlisartan/Amlosipine(Twinsta®) and Rosuvastatin(Crestor®)
15952221|NCT03247127|Radiation|Hippocampal avoidance whole brain radiotherapy|Planning target volume(PTV) for whole brain is Whole brain parenchyma plus2mm margin excluding metastases and HA region, 30Gy in 10 fractions will be delivered to PTVwhole brain. Bilateral Hippocampus will be contoured according to Radiation Therapy Oncology Group 0933 and hippocampal avoidance region is Hippocampi + 5mm margin. According to Radiation Therapy Oncology Group 0933 trial, dose to 100% of the hippocampus could not exceed 9 Gy, and maximal hippocampal dose could not exceed 16 Gy; dose to 100% of the hippocampus exceeding 10 Gy
15952222|NCT03247114|Other|Water|Water, 300 ml at room temperature
15952223|NCT03247114|Other|Glucose|Glucose, 50 grams in 300 ml water at room temperature
15952224|NCT03247114|Other|Fructose|Fructose, 50 grams in 300 ml water at room temperature
15952225|NCT03247114|Other|Sucrose|Sucrose, 50 grams in 300 ml water at room temperature
15952226|NCT03247114|Other|Sucralose|Sucralose, 0.33 grams in 300 ml water at room temperature
15952227|NCT03247101|Drug|Miyarisan-BM (Clostridium Butyricum Miyairi)|40mg po tid x 6months
15952228|NCT03247101|Drug|Urso group|ursodoxycholic acid, 200mg po tid x 6 months
15952229|NCT03247101|Drug|Biotase group|Biotase 1# [Biodiastase 30mg + lipase 65mg + newlase 10mg]/tab po tid x 6 months
15952230|NCT03247088|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic HSCT IV
15952231|NCT03247088|Drug|Busulfan|Given IV
15952232|NCT03247088|Drug|Cyclophosphamide|Given IV
15952233|NCT03247088|Biological|Filgrastim|Given SC
15952234|NCT03247088|Drug|Fludarabine|Given IV
15952235|NCT03247088|Drug|Mycophenolate Mofetil|Given PO
15952236|NCT03247088|Drug|Sorafenib|Given PO
15952237|NCT03247088|Drug|Tacrolimus|Given PO
15952238|NCT03247075|Behavioral|Cognitive Behavior Therapy|Guided Internet-delivered CBT includes exposure training, coping techniques and cognitive components, intended to reduce social anxiety symptoms
15952239|NCT03247075|Behavioral|Support and Counseling|Guided Internet-delivered support and counseling includes educative material about social anxiety and health related issues such as physical activity, nutritious diet, sleep habits etc.
15952240|NCT03247062|Other|Quality improvement - sleep bundle|implementation of a sleep bundle
15952241|NCT03247036|Drug|IV thrombolytic (t-PA) treatment vs not|Acute Stroke Protocol
15952242|NCT03247023|Device|Implantation of Integra Cadence Total Ankle Sysyem|Primary Ankle Arthroplasty
15952243|NCT03247010|Other|Blood sampling|Blood samples are taken before each cycle of Radium 223
15952244|NCT03246997|Other|Autumn Group|The intervention is participating in a fruit and vegetable farm share for 6 months.
15952245|NCT03246997|Other|Spring Group|The intervention is participating in a fruit and vegetable farm share for 6 months.
15952246|NCT03246984|Device|VasQ|VasQ device implantation in patients with a new brachiocephalic or radiocephalic fistula creation.
15952247|NCT03246971|Drug|Wafermine™ 50 mg|Administered as needed for 12 hours
15952248|NCT03246971|Drug|Wafermine™ 75 mg|Administered as needed for 12 hours
15952249|NCT03246971|Drug|Placebos|Administered as needed for 12 hours
15952250|NCT03246971|Drug|Wafermine™ 25 mg|Administered as needed for 12 hours
15952251|NCT03246958|Drug|Nivolumab|Ipilimumab are types of immunotherapy Immunotherapy works by encouraging the body's own immune system to attack cancer cells.
15952252|NCT03246958|Drug|Ipilimumab|Nivolumab are types of immunotherapy. Immunotherapy works by encouraging the body's own immune system to attack cancer cells.
15952253|NCT03246945|Behavioral|Instructions on taking photographs provided, see methods|Parent-patient dyads were provided with written 3-step instructions on how best to take a photograph of skin conditions using a smart phone
15952254|NCT03246932|Behavioral|Peer-led psycho-education group|A structured, researcher-designed peer-led psycho-education program (6 months), comprising of 12 bi-weekly, 2-hour group sessions.
15952255|NCT03246932|Behavioral|Profession-led psycho-education group|A psychoeducation group program (12 sessions, bi-weekly).
15952256|NCT03246932|Other|Routine psychiatric care|Routine psychiatric outpatient care, or Treatment-as-usual (TAU).
15952257|NCT03246919|Drug|Oxytocin|Oxytocin is administered after delivery of the fetal anterior shoulder, rather than being administered after delivery of the placenta
15952258|NCT03246919|Drug|Placebo|Placebo will be administered after delivery of the placenta
15952259|NCT03246906|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo HCT
15952260|NCT03246906|Drug|Cyclophosphamide|Given IV
15952261|NCT03246906|Drug|Cyclosporine|Given PO
15952262|NCT03246906|Drug|Mycophenolate Mofetil|Given PO
15952263|NCT03246906|Drug|Sirolimus|Given PO
15952264|NCT03246893|Device|Noninvasive positive pressure ventilation|"Noninvasive positive pressure ventilation will apply via a face mask with initial setting as the following:
~Inspiratory pressure 6-8 cmH2O Expiratory pressure 3-5 cmH2O FiO2 30-60% Respiratory rate 12-16 per min"
15952265|NCT03246893|Device|High flow oxygen nasal cannula|"High flow oxygen nasal cannula will apply to patient via a nasal cannula with initial setting as the following:
~Temperature 37 degree celsius Flow 30 liter per min FiO2 40-60%"
15952266|NCT03246880|Drug|Tamsulosin 0.2mg|per oral for 12weeks after 2~4weeks run-in period
15952267|NCT03246880|Drug|Tadalafil 5mg|per oral for 12weeks after 2~4weeks run-in period
15952268|NCT03246867|Other|Isolytic stretching group|In modified cross body position, isolytic stretching exercises will perform five times each for 15 seconds. After each stretching patient will rest for 5 seconds. When the patient contracts the agonist muscle group with 20% muscle force, the agonist muscle group is stretched at the same time for 2-4 seconds. Afterwards active-assistive stretching is done. Evaluations will be done before and just after stretching exercise.
15952269|NCT03246867|Other|Static stretching group|In modified cross body position, active-assistive static stretching exercises will be performed 5 times each for 15 seconds. This stretching exercise is performed 5 times with 5 seconds intervals. Evaluations will be done before and just after stretching exercise.
15953676|NCT03236233|Drug|PC786 - Repeat doses|Safety and tolerability of repeat doses
15952270|NCT03246867|Other|Control group|Control group will receive no stretching. They will be handed a brochure about the stretching techniques and its role in injury prevention. Control group will be evaluated for the first time and then will be passively waited until the duration of the stretching exercise program (approximately 4-5 min). Afterwards, second evaluation will be performed.
15952271|NCT03246854|Drug|DBPR112|DBPR112 hard gelatin capsule solid dosage formulation; strength: 25 mg, 100 mg.
15952272|NCT03246841|Other|Genetic testing|A panel of 24 genes, chosen in advance by a steering committee, will be tested as the same time as the BRCA1/2 genes, at one of the usual BRCA1/2 analysis laboratories belonging to the same network and participating in the study.
15952273|NCT03246828|Other|Omission of gliclazide|Participants will stop taking gliclazide for 3 days. Data from the OGTT will be compared with that prior to stopping the medication.
15952274|NCT03246802|Radiation|HDR partial prostate brachytherapy|temporary radioactive implant
15952275|NCT03246789|Behavioral|Engage-M|Engage is a stepped care psychotherapy based on what is known about how older adults respond to depression interventions. Stepped care is a model of treatment that starts with the minimum effective therapeutic techniques first, and then based on how well people respond to treatment, additional therapeutic techniques are added until people are recovered from their depression.
15952276|NCT03246789|Behavioral|Wellness in Mind and Body|An active intervention focusing on psychoeducation and de-stigmatization of health and mental health conditions. These sessions are commonly part of senior centers programs. W-MH will offer mental health referral to a clinic or primary care physician as part of senior center procedures for clients with positive PHQ-9s.
15952277|NCT03246776|Drug|Halometasone Triclosan|Halometasone Triclosan . The study product will be applied topically twice a day (morning and evening) for 14 days of treatment
15952278|NCT03246763|Behavioral|Integrated community-healthcare childhood obesity treatment|"The intervention will include nutrition and fitness programming at a local community center. The program will be open at least two sessions per week, each session lasting at least 1 hour. The program coordinator will run the programming, which will consist of wellness activities. Each session will include at least 60 minutes of exercise and/or active play, and each session will have an additional special theme. For example, one session might include a cardio focused class, and one session might include a yoga class. The number and which sessions the participants attend each week is voluntary; clinic staff will recommend participation in as many sessions per week as possible. Participation is voluntary, and patients may opt-out at any time. Participants will be told that they can indicate to their provider or the program coordinator at any time either by phone or during the clinic appointment that they wish to opt-out of the study and its assessments."
15952279|NCT03246750|Drug|B-MAD chemotherapy|B-MAD chemotherapy
15952280|NCT03246737|Other|monitoring|
15952281|NCT03246724|Drug|Triazolam|"This will be used for oral sedation. This capsule or a microcrystalline cellulose placebo capsule will be administered depending on the randomized treatment group.
~Dose for BMI less than 35: 0.125 mg
~Dose for BMI greater than or equal to 35: 0.25 mg"
15952282|NCT03246724|Drug|Midazolam|"This will be used for intravenous sedation. This injection or sodium chloride 0.9% will be administered depending on the randomized treatment group.
~Dose for BMI less than 35: 1.0 mg
~Dose for BMI greater than or equal to 35: 2.0 mg"
15952283|NCT03246724|Drug|Microcrystalline Cellulose|"This will be used for the oral placebo. This capsule or a triazolam capsule will be administered depending on the randomized treatment group.
~Dose for BMI less than 35: 1 capsule
~Dose for BMI greater than or equal to 35: 2 capsule"
15952284|NCT03246724|Drug|Sodium chloride 0.9%|"This will be used for the intravenous placebo.This injection or midazolam will be administered depending on the randomized treatment group.
~Dose for BMI less than 35: volume to match volume of active intravenous medication
~Dose for BMI greater than or equal to 35: volume to match volume of active intravenous medication"
15952285|NCT03246711|Behavioral|Fasting|Totally or partially fasting the holy month of ramadan for muslims
15952286|NCT03246698|Other|Isolytic Stretching group|In modified cross body position, isolytic stretching exercises will perform five times each for 15 seconds. After each stretching patient will rest for 5 seconds. When the patient contracts the agonist muscle group with 20% muscle force, the agonist muscle group is stretched at the same time for 2-4 seconds. Isolytic stretching exercises will perform four times a week for four weeks. It's obligatory to receive at least 15 sessions in total. They will also receive standard physiotherapy program four times a week for four week, 15 sessions in total.
15952287|NCT03246698|Other|Static Stretching group|In modified cross body position, active-assistive static stretching exercises will be performed 5 times each for 15 seconds. This stretching exercise is performed 5 times with 5 seconds intervals. Static stretching exercises will perform four times a week for four weeks. It's obligatory to receive at least 15 sessions in total. They will also receive standard physiotherapy program four times a week for four week, 15 sessions in total.
15952288|NCT03246698|Other|Control group|They will receive only standard physiotherapy program, four times a week for four weeks, 15 sessions in total.
15952289|NCT03246685|Biological|Imprime PGG|Imprime PGG is a soluble, β-1,3/1,6 glucan isolated from the cell wall of a proprietary Saccharomyces cerevisiae yeast strain. Imprime PGG acts as a Pathogen-Associated Molecular Pattern (PAMP). Imprime will be administered at a dose of 4 mg/kg IV over a 2-hour infusion time on Days 1, 8 and 15 of each 3-week treatment cycle.
15952290|NCT03246685|Drug|Pembrolizumab|Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 protein. Pembrolizumab will be given at a fixed dose of 200 mg IV over 30 minutes on Day 1 of each 3-week treatment cycle after the Imprime infusion.
15952291|NCT03246672|Behavioral|maintenance intervention|Participants will receive calls at weeks 1, 2, 3, 4, 6, 8, 10, 12, and 14 that focus on satisfaction with outcomes of behavior change, self-monitoring, relapse planning, and social support.
15952292|NCT03246659|Drug|111In-CP04|Radiopharmaceutical preparation
15952293|NCT03246659|Drug|111In-CP04 with co-administration of gelofusine/gelaspan|Radiopharmaceutical preparation with co-administration of gelofusine/gelaspan
15952294|NCT03246646|Behavioral|Coaching|Telephone coaching was provided in a series of telephone based sessions with CSO participants
15952295|NCT03246633|Other|Perceptual Training|Participants will assess skin lesions before and after completion of an online/mobile course that has the goal of learning to triage pigmented lesions as benign or malignant. Participants will also help evaluate the usability and effectiveness of the course by completing a questionnaire after completion of the course.
15952296|NCT03246620|Drug|Olanzapine oro-dispersible 5Mg Tab|Patient allocated to this arm will be given 5 mg olanzapine oro-dispersible tablet and an encapsulated placebo tablet
15952297|NCT03246620|Drug|Haloperidol 2Mg encapsulated Tab|Patient allocated to this arm will be given 2 mg encapsulated haloperidol tablet and an oro-dispersible placebo tablet
15952298|NCT03246620|Drug|Diazepam 2Mg encapsulated Tab|Patient allocated to this arm will be given 2 mg encapsulated diazepam tablet and an oro-dispersible placebo tablet
15952299|NCT03246607|Device|MicroEye & ContinuMon|Continuous intravascular glucose monitoring using MicroEye/ContinuMon system, peripherally inserted via a peripheral venous catheter.
15952300|NCT03246594|Device|Placement of oesophageal probe for temperature measurement|The oesophagus probe is used to measure the intraluminal temperature inside the oesophagus
15952301|NCT03246594|Device|Power limitation of RF generator|no probe utilized; Limit the RF Generator Output to 25W
15952302|NCT03246581|Drug|Tiotropium|inhalation
15952305|NCT03246555|Drug|Fimasartan or Fimasartan/Hydrochlorothiazide|The treatment in this clinical study starts with fimasartan 30 mg; if blood pressure is not controlled (siSBP ≥ 140 mmHg or siDBP ≥ 90 mmHg), the dose is escalated once gradually, and then a diuretic combination is administered. The escalation of dose and administration of diuretic combination are decided after checking blood pressure 4 weeks after the administration of each investigational product.
15952306|NCT03246555|Drug|Perindopril or Perindopril/Indapamide|The treatment in this clinical study starts with penrindopril 2.5 mg; if blood pressure is not controlled (siSBP ≥ 140 mmHg or siDBP ≥ 90 mmHg), the dose is escalated once gradually, and then a diuretic combination is administered. The escalation of dose and administration of diuretic combination are decided after checking blood pressure 4 weeks after the administration of each investigational product.
15952307|NCT03246542|Diagnostic Test|shistocytes percentage|
15952308|NCT03246529|Drug|BL-8040 1.25mg/kg + G-CSF|Up to 2 SC injections of BL-8040 are anticipated during the study. Injections of G-CSF per standard of care
15952309|NCT03246529|Drug|Placebo +G-CSF|Up to 2 SC injections of Placebo are anticipated during the study. Injections of G-CSF per standard of care
15952310|NCT03246516|Other|Questionnaire|"Auto and hetero questionnaires:
~STAI Y B, State-Trait Anxiety Inventoriage
~Brief COPE
~RHHI-24, Revised Health Hardiness Inventory
~IPQ-R, Illness Perception Questionnaire"
15952311|NCT03246490|Other|All Participants|all participants will participate in the same protocol involving drinking alcohol to a .08 g% blood alcohol level
15952312|NCT03246464|Device|Orthokeratology lenses|Rigid gas permeable contact lenses
15952313|NCT03246464|Device|Single-vision spectacles|Regular single vision spectacles
15952314|NCT03246451|Drug|Placebo Oral Tablet|2-4 tablets in 14 days
15952315|NCT03246451|Drug|Metformin|1000-2000 mg in 14 days
15952316|NCT03246451|Drug|Saline|9 mg/ml saline infusion during experimental days
15952317|NCT03246451|Drug|Exendin (9-39)|Infusion of GLP-1 receptor antagonist used as a tool during experimental days
15952318|NCT03246438|Behavioral|Colonoscopy only|Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line. Subjects not scheduled after 4 weeks will receive a reminder letter to schedule colonoscopy.
15952319|NCT03246438|Behavioral|Colonoscopy outreach + mailed FIT follow-up|Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line. Subjects not scheduled after 4 weeks will receive a reminder letter to either schedule colonoscopy or to complete the enclosed mailed FIT kit.
15952320|NCT03246438|Behavioral|Colonoscopy + Mailed FIT outreach and follow-up|Subjects will receive a mailed communication describing the importance of colorectal cancer screening with the option to schedule a colonoscopy through a VIP direct scheduling phone line OR complete the enclosed mailed FIT kit. Subjects who have not completed FIT or scheduled colonoscopy within 4 weeks will be receive a reminder letter to either schedule colonoscopy or complete the mailed FIT kit previously sent.
15952323|NCT03246412|Diagnostic Test|Nevus doctor clinical decision support|The computer program analyzes dermatoscopic images. The output is an estimate of the risk of the skin lesion representing skin cancer. The decision support tool helps the doctor to assess the significance of the computer output by taking into account clinical information.
15952324|NCT03246399|Drug|SM04690|suspension formulation of SM04690, delivered via intradiscal injection (single injection)
15952325|NCT03246386|Drug|Posaconazole Injection [Noxafil] 300mg|Single dose by intravenous infusion 300mg
15952326|NCT03246386|Drug|Posaconazole Injection [Noxafil] 400mg|Single dose by intravenous infusion 400mg
15952327|NCT03246360|Drug|Modification for administration mode of cloxacillin antibiotic|"For intermittent administration, patients will benefit from cloxacillin treatment in conventional hospitalization, in accordance with national guidelines, at a dose of 150 mg / kg per day in 4 infusions, not exceeding the maximum daily dose of 12 g / day according to.
~For continuous administration the same quantity of cloxacillin 150 mg / kg per day, without exceeding the maximum daily dose of 12 g / day, will be delivered by a self-propelled syringe in twice 12 hours. Patients randomly assigned to receive continuous administration will receive a dose of cloxacillin equivalent to the dose administered 4 times daily during iterative administration using a self-pulsating syringe. For the first day of the study, this loading dose will be subtracted from the 150 mg / kg dose to be administered continuously over the remaining 23 hours of the first day of the study and never exceed 12g / day.
~Pharmacological dosages will be performed on the third and sixth day in both arms"
15952328|NCT03246347|Drug|ADT+Docetaxel+Enzalutamide|combination therapy as listed above
15985917|NCT02993523|Drug|Venetoclax|Tablet
15952329|NCT03246321|Combination Product|repetitive ePIPAC-OX|Instead of standard palliative treatment, enrolled patients receive laparoscopy-controlled electrostatic pressurised intraperitoneal aerosol chemotherapy with oxaliplatin (ePIPAC-OX) (92 mg/m2 body-surface area [BSA]) with intravenous leucovorin (20 mg/m2 BSA) and bolus 5-fluorouracil (400 mg/m2 BSA) every six weeks. Four weeks after each procedure, patients undergo clinical, radiological, and biochemical evaluation. ePIPAC-OX is repeated until clinical, radiological, or macroscopic disease progression, after which standard palliative treatment is (re)considered.
15952330|NCT03246308|Radiation|Phototherapy|Taking blood sample.
15952331|NCT03246295|Other|lifestyle intervention or insulin treatment|Firstly，the gestational diabetes mellitus（GDM） women were treated with lifestyle intervention.Those women were treated with insulin if their blood glucose was not well Controled.
15952332|NCT03246282|Device|UVL1000 Treatment Station|"Non-coherent light source administered 365 nm, 630 nm, and 530 nm at an output intensity of 0.1 mW directly into an existing intravascular 20 gauge 1.0 catheter"
15952333|NCT03246282|Drug|Normal Saline 0.9% Infusion Solution Bag|250 ml of 0.9% Sodium Chloride Solution
15952334|NCT03246282|Device|Peripheral Catheterization|"20-gauge 1.0 catheter"
15952335|NCT03246269|Diagnostic Test|MoCA|
15952336|NCT03246256|Other|Group 1|
15952337|NCT03246243|Device|nfant feeding solution|The study will record the sucking activity of the hospitalized infants over time, from their first oral sucking session including non-nutritive and nutritive sucking, until discharge, using an FDA-approved device that equips a typical bottle and nipple commonly used in the NICU with a non-invasive sensor to measure sucking activity. Each infant's nutritive and non-nutritive sucking patterns will be measured, and will comprise the 'sucking session' conducted with the bottle sensor.
15952338|NCT03246230|Biological|Hepatitis B vaccine (HBV)|Licensed pediatric HBV vaccine will be administered at birth (Day of Life 0) or delayed to Day of Life 7.
15952339|NCT03246230|Biological|Bacillus Calmette-Guérin (BCG)|Licensed BCG vaccine will be administered at birth (Day of Life 0) or delayed to Day of Life 7.
15952340|NCT03246217|Behavioral|Therapeutic Instrumental Music Performance|Participants will play a variety of instruments (acoustic and electronic) to facilitate retraining of everyday functional movements.
15952341|NCT03246217|Behavioral|Therapeutic Performance with Sensory-Enhanced Motor Imagery|Participants will listen to a metronome set to their preferred pace for previously practised movements while engaging in motor imagery.
15952342|NCT03246217|Behavioral|Therapeutic Performance with Motor Imagery|Participants will engage in motor imagery of previously practised movements.
15952343|NCT03246191|Other|blood sample collection|blood sample collection
15952344|NCT03246178|Other|MSD-HSCT|"Conditioning regimens: (A) Patients had SAA and PNH, or heavy transfusion (RBC≥25U), or failed rabbit ATG therapy, and received 0.8 mg/kg/6h busulfan (days -7 to -6), 30mg/m2/day fludarabine (days -5 to -2), 25 mg/kg/day cyclophosphamide (days -5 to -2) and 2.5 mg/kg/day r-ATG (days -5 to -2). (B) The other patients with SAA or VSAA received same procedure but without busulfan;
~Allogeneic HSC infusion: Doner BM cells were harvested to achieve a target mononuclear cell count (MNC) of 2-4 × 108 per kilogram of recipient weight. The target MNC from PB was 4-6× 108 per kilogram of recipient weight;
~Prophylaxis and treatment of GVHD: GVHD prophylaxis consisted of intravenous CSP 2-3 mg/kg/day in divided doses beginning on the day before transplantation (day -5) and the target concentration was adjusted to 150-250 ng/ml. The oral MMF dose was 20 mg/kg/day from day -1 and was tapered off after 1 months if no aGVHD was observed."
15952345|NCT03246178|Other|HFD-HSCT|"Conditioning regimens: (A) Patients had SAA and PNH, or heavy transfusion (RBC≥25U), or failed rabbit ATG therapy, and received 0.8 mg/kg/6h busulfan (days -7 to -6), 35mg/m2/day fludarabine (days -5 to -2), 25 mg/kg/day cyclophosphamide (days -5 to -2) and 2.5 mg/kg/day r-ATG (days -5 to -2). (B) The other patients with SAA or VSAA received same procedure but without busulfan;
~Allogeneic HSC infusion: Doner BM cells were harvested to achieve a target mononuclear cell count (MNC) of 2-4 × 108 per kilogram of recipient weight. The target MNC from PB was 4-6× 108 per kilogram of recipient weight;
~Prophylaxis and treatment of GVHD: GVHD prophylaxis consisted of intravenous CSP 2-3 mg/kg/day in divided doses beginning on the day before transplantation (day -5) and the target concentration was adjusted to 200-300 ng/ml. The oral MMF dose was 20 mg/kg/day from day -3 and was tapered off after 2 months if no aGVHD was observed."
15952346|NCT03246165|Procedure|Cardiac surgery|Coronary bypass, heart valve replacement
15952347|NCT03246152|Drug|Bevacizumab|Repeated intravitreal injections of Bevacizumab monthly
15952348|NCT03246139|Behavioral|Action observation, imagery & execution|The participants will be asked to observe movements through a video clip, practice motor imagery, and executing the movements that the participants observed.
15952349|NCT03246139|Behavioral|Action observation|The participants will be asked to observe videos and then practice what the participants observed.
15952350|NCT03246139|Behavioral|Control treatment|The participants will receive UE training without watching videos or imagining movements/tasks.
15952351|NCT03246126|Device|Valiant™Thoracoabdominal Stent Graft System|The Visceral Manifold System is comprised of the Thoracic Bifurcation and Visceral Manifold to treat a thoracoabdominal aortic aneurysm or TAAA. The experimental procedure to implant the stent graft will be done in an operating room and will last anywhere from four to eight hours, but may take longer.
15952352|NCT03246113|Drug|Cannabis|Cannabis cigarettes provided by NIDA that contain high levels of CBD (4.8%) and low levels of THC (3.23%). Patients will smoke one-half (1/2) to two (2) cannabis cigarettes prior to receiving chemoradiation.
15952353|NCT03246113|Drug|Temozolomide|Oral alkylating agent with demonstrated antitumor activity.
15952354|NCT03246113|Radiation|Radiation Therapy|standard fractionation radiotherapy of 60 Gy in 30 treatments with temozolomide.
15952355|NCT03246100|Behavioral|Reminders|Reminders are sent either through autodial or postcards reminding patients to get flu vaccine.
15952356|NCT03246087|Device|Acupunture|"acupuncture for plantar fasciosis
~Acupuncture will be performed and the standard of care prescribed home exercise program will be reviewed."
15952357|NCT03246087|Other|Standard of care|standard of care home exercise program
15952359|NCT03246061|Device|Intracept System|BVN ablation using radiofrequency energy
15952360|NCT03246061|Other|Standard Care|Non-surgical standard care
15985918|NCT02993523|Drug|Placebo|Tablet
15952361|NCT03246035|Behavioral|Intervention Group|For the intervention arm, a specialized heart failure nurse practitioner will contact the patient or their primary caregiver by telephone within 5 days post-discharge and send them an education packet by mail. During the telephone call, the nurse will (1) confirm the patient's scheduled follow-up appointment in cardiology, (2) provide recommendations for heart failure self-care behaviors that were found to be deficient at baseline. Patients will then be referred to a Geriatrics Assessment Team, who will provide individualized recommendations for frailty domains that were found to be deficient at baseline. The technique used to provide educational recommendations will be motivational interviewing.
15952362|NCT03246035|Other|Control Group (Standard Care)|For patients randomized to the Control Group (Standard Care), they will receive their follow-up visits, medications, diet and physical activity advice as they normally would. This is the care they would receive even if they were not enrolled in the study
15952363|NCT03246022|Other|continuous positive airway pressure|Continuous positive airway pressure (CPAP) prevents the airway collapse, avoids the occurrence of intermittent hypoxemia and arousal, is the preferred treatment for OSAS and has been widely used in clinical. The investigator would compare the effect of CPAP treatment on awake and sleep BP level at the first night and 2 weeks therapy among three groups. Moreover, whether or not the sympathetic-parasympathetic nerve balance and the renin-angiotensin-aldosterone system are different in three groups would also be evaluated.
15952364|NCT03246009|Drug|rHSA/GCSF|single injection-1.8mg
15952365|NCT03246009|Drug|rHSA/GCSF|single injection-2.1mg
15952366|NCT03246009|Drug|rHSA/GCSF|single injection-2.4mg
15952367|NCT03246009|Drug|rHSA/GCSF|multiple injection-1.8mg
15952368|NCT03246009|Drug|rHSA/GCSF|multiple injection-2.1mg
15952369|NCT03246009|Drug|rHSA/GCSF|multiple injection-2.4mg
15952370|NCT03245996|Device|AAI 40 bpm|Cardiac pacemaker of the subjects is set to AAI-mode 40 bpm in the first and second part of the study
15952371|NCT03245996|Device|AAI 60 bpm|Cardiac pacemaker of the subjects is set to AAI-mode 60 bpm in the first and second part of the study
15952372|NCT03245996|Device|AAI 90 bpm|Cardiac pacemaker of the subjects is set to AAI-mode 90 bpm in the first and second part of the study
15952373|NCT03245996|Drug|Atenolol Pill|50 or 100 mg of atenolol is administered to subjects in the second part of the study
15952374|NCT03245996|Drug|Nebivolol Pill|5 mg of nebivolol is administered to subjects in the second part of the study
15952375|NCT03245996|Drug|Ivabradine Pill|5 or 7,5 mg of ivabradine is administered to subjects in the second part of the study
15952376|NCT03245983|Behavioral|Questionnaire and interview|Cancer patients will answer questionnaires and will be interviewed by a pshychologist to assess their spirituality and quality of life toward their disease
15952377|NCT03245970|Drug|Labetalol Hydrocholoride 200 mg orally every 12 hours|Anti-hypertensive prescribed for increased cardiac output as determined by impedance cardiography
15952378|NCT03245970|Drug|Nifedipine 60 mg orally daily|Anti-hypertensive medication prescribed for increased systemic vascular resistance as determined by impedance cardiography
15952379|NCT03245970|Drug|Atenolol 25 mg daily|Anti-hypertensive prescribed for increased cardiac output with tachycardia or maternal pulse rate 110 or greater
15952380|NCT03245957|Other|Ischemic stroke|Patients with acute stage of stroke clinical picture, with ischemic, haemorrhagic or mimick stroke diagnosed using MRI or CT scan
15952381|NCT03245957|Other|Haemorrhagic stroke|Patients with acute stage of stroke clinical picture, with ischemic, haemorrhagic or mimick stroke diagnosed using MRI or CT scan
15952382|NCT03245944|Procedure|early Angioplasty|Angioplasty is a minimally invasive, endovascular procedure to widen narrowed or obstructed arteries or veins. A deflated balloon attached to a catheter (a balloon catheter) is passed over a guide-wire into the narrowed vessel and then inflated to a fixed size. The balloon forces expansion of the blood vessel and the surrounding muscular wall, allowing an improved blood flow. This is part of standard of care for immature arteriovenous fistulas. Early means pt will get the procedure at 6 weeks from time of initiation of AVFs
15952383|NCT03245944|Procedure|late Angioplasty|Angioplasty is a minimally invasive, endovascular procedure to widen narrowed or obstructed arteries or veins. A deflated balloon attached to a catheter (a balloon catheter) is passed over a guide-wire into the narrowed vessel and then inflated to a fixed size. The balloon forces expansion of the blood vessel and the surrounding muscular wall, allowing an improved blood flow. This is part of standard of care for immature arteriovenous fistulas. Late means the angioplasty is done at 3 months from time of AVF creation if still immature at that time.
15952384|NCT03245931|Other|Qualitative Interview|Complete 6 open-ended qualitative questions on patients in the HOPE program to assess basic current understanding about Hepatitis C and topics of interest that patients in the HOPE program would like to learn more about.
15952385|NCT03245918|Drug|Aprepitant Capsule 125 MG|Patients will be randomized to either the aprepitant capsule or oral suspension for the first study period, and will receive the alternate formulation during the second study period
15952386|NCT03245918|Drug|Aprepitant oral suspension 20 mg/mL|Patients will be randomized to either the aprepitant capsule or oral suspension for the first study period, and will receive the alternate formulation during the second study period
15952387|NCT03245905|Drug|Chidamide|Chidamide 30mg orally BIW. Treatment cycles are repeated every 3 weeks.The maximum duration of treatment is 2 years.
15952388|NCT03245892|Drug|Carboplatin and Paclitaxel|Paclitaxel 80mg/m2 will be administered over approximately 1 hour as an IV infusion on Days 1,8, and 15 of each 21-day cycle. Carboplatin AUC6 will be administered as approximately a 30 minute IV infusion, following paclitaxel administration on Day 1 of each 21-day cycle.
15952389|NCT03245892|Drug|Nivolumab|Nivolumab 360mg will be infused IV over approximately 30 min on Day 1 of Cycles 1-6 (to 8) of each 21 day cycle. During the maintenance phase, Nivolumab 480mg will be infused IV over approximately 30 min on day 1 of each 28 day cycle, for up to 12 months. During the maintenance period, each cycle is 4 weeks
15952390|NCT03245892|Procedure|Cytoreductive surgery|Cytoreductive surgery
15952391|NCT03245892|Drug|Ipilimumab|Ipilimumab 1mg/kg every 6 weeks x 3-6 cycles in the neoadjuvant setting (maximum 2 doses of ipilimumab)
15952462|NCT03245346|Drug|GEA|Thoracic epidural catheterization will be performed and epidural anesthesia will be maintained with 0.25% ropivacaine during surgery. General anesthesia will be maintained with inhalation (sevoflurane) and muscle relaxants will be administered when considered necessary.
15987520|NCT02981927|Other|Physical inactivity|
15952392|NCT03245879|Behavioral|Program 1|Program 1 hospitals received a basic curriculum and tools for implementation of basic antibiotic stewardship interventions. Hospitals required an indication for every antibiotic order. A daily email was sent to a designated email account when a patient had been on an antibiotic for >48 hours. Curriculum included implementing antibiotic time-outs, IV to PO conversion, indications, evaluating for bug-drug mismatches, and recommendations on when to call the Infectious Diseases (ID) hotline. A daily antibiotic stewardship check list was created. All materials were provided to all pharmacists and remained on-site. Clinicians had access to an ID telephone hotline to answer clinical questions. Pharmacy directors and hospital leadership were provided a monthly, hospital-specific, antibiotic use dashboard. All pharmacy directors and staff received a monthly newsletter.
15952393|NCT03245879|Behavioral|Program 2|Program 2 hospitals received all the interventions of Program 1. In addition, Program 2 hospitals received more intense antibiotic stewardship education. Educational topics included audit and feedback, antibiotic de-escalation, the need for antibiotics targeting anaerobic bacteria, antibiotic allergy verification, and antibiotic restrictions. Pharmacists in Program 2 hospitals reviewed patients on vancomycin, piperacillin/tazobactam, imipenem, meropenem, and cefepime. For patients receiving one of these antibiotics, pharmacists reviewed the patients' microbiology data to identify opportunities for antibiotic de-escalation, IV to PO conversion, bug-drug mismatches, and/or indications for calling the ID hotline. Program 2 hospitals also restricted daptomycin, linezolid, imipenem, meropenem, ceftaroline, tigecycline, and all mold active antifungals. In Program 2 hospitals, the local pharmacy staff pre-authorized restricted antibiotics based on defined criteria.
15952394|NCT03245879|Behavioral|Program 3|Program 3 hospitals received all the interventions of Program 1 and Program 2. In addition, pharmacists in program 3 hospitals reviewed an expanded list of antibiotics for audit and feedback. These antibiotics included: Vancomycin, piperacillin/tazobactam, imipenem, meropenem, cefepime, ertapenem, aminoglycosides, ceftriaxone, and fluoroquinolones. Program 3 hospitals implemented the same antibiotic restrictions as Program 2 but ID pharmacists controlled pre-authorization of restricted antibiotics. In addition, an ID physician reviewed pre-specified positive cultures (e.g. all positive blood cultures, cultures with highly resistant Enterobacteraciae) and contacted providers with recommendations as needed. ID physician review occurred Monday through Friday and alerts were batched daily at 6am.
15952395|NCT03245866|Other|Observational/ no intervention|
15952396|NCT03245853|Drug|Riboflavin 5'-Phosphate|Photrexa (riboflavin 5'-phosphate ophthalmic solution) 0.146%, is a yellow sterile buffered solution containing 1.46 mg/mL riboflavin 5'-phosphate, The pH of the solution is approximately 7.1 and the osmolarity is 157-177 mOsm/kg. Each 1 mL of the solution contains 1.53 mg of riboflavin 5'-phosphate sodium (equivilant to 1.20 mg [0.12%] riboflavin). Riboflavin 5'-phosphate sodium USP is a mixture of the sodium salts of riboflavin, riboflavin monophosphates, and riboflavin diphosphates. The inactive ingredients are dibasic sodium phosphate, monbasic sodium phosphate, sodium chloride, and water for injection.
15952397|NCT03245840|Drug|Budesonide oral suspension|Budesonide oral suspension (BOS) 10 mL twice daily
15952398|NCT03245827|Drug|Clomiphene|clomiphene capsule 25mg twice a week
15952399|NCT03245827|Drug|Placebo|placebo capsule 25mg twice a week
15952400|NCT03245814|Behavioral|Service Dog|A service dog trained to perform tasks that are specific to PTSD
15952401|NCT03245788|Other|Lay Navigation|Patients who are assigned to intervention will be contacted by a navigator who will explain and offer their services to the patient. Navigators focus efforts on supporting patients in self-management and in supporting non-medical needs.
15952402|NCT03245775|Behavioral|iChoose|12 bi-weekly sessions & 24 IVR calls/12 months, 24 physical activity sessions over 6 months; delivers intervention to parents and children only
15952403|NCT03245775|Behavioral|Family Connections|2 in-person sessions spaced one week apart & 10 IVR calls/6 months, promotes physical activity but does not include structured exercise sessions; delivers intervention to parents only
15952404|NCT03245762|Drug|Oxytocin|4 IU/day of oxytocin administered via nasal spray device each morning.
15952405|NCT03245762|Drug|Placebo|4 IU/day of placebo administered via nasal spray device each morning
15952406|NCT03245736|Drug|Tisotumab Vedotin|All patients in the trial will be administered tisotumab vedotin (HuMax-TF-ADC).
15952407|NCT03245723|Procedure|Pulmonary Function Testing|Subjects will undergo Spirometry and Plethysmography
15952408|NCT03245723|Procedure|Electrocardiogram|Subjects will undergo an electrocardiogram to ensure sinus rhythm
15952409|NCT03245723|Procedure|Positron Emission Tomography|Subjects will undergo positron emission tomography to detect images of the heart
15952410|NCT03245723|Procedure|Magnetic Resonance Imaging|Subjects will undergo positron magnetic resonance imaging to detect images of the heart
15952411|NCT03245710|Other|Placebos|starch
15952412|NCT03245710|Dietary Supplement|Zhibai Dihuang powder|the Traditional Chinese Medicine Formula Powder Product
15952413|NCT03245684|Diagnostic Test|assessment of inflammatory response during PSV|assessment cytokines level in BAL and plasma
15952414|NCT03245671|Drug|Kenalog Injectable Product|80 mg of Kenalog will be used.
15952415|NCT03245671|Drug|Decadron Phosphate, Injectable|15 mg of Decadron will be used.
15952416|NCT03245671|Procedure|Epidural Steroid Injection|Patient will receive epidural steroid injections of either Kenalog or Decadron.
15952417|NCT03245658|Drug|THC and CBD Mixture|Individually titrated doses on daily basis
15952419|NCT03245632|Other|Carbapenem-Resistant Klebsiella pneumoniae|no intervention, this is an obervational study.
15952463|NCT03245346|Drug|PCEA|Patient-controlled epidural analgesia (0.15% ropivacaine infusion) will be provided after surgery.
15953677|NCT03236233|Drug|Placebo - Repeat doses|Safety and tolerability of repeat doses
15952420|NCT03245619|Drug|GSK3335065|GSK3335065 is being developed as a treatment for acute pancreatitis with the intent of reducing 3-hydroxykynurenine (3HK) levels to the normal range (or lower) and maintaining them at this level. GSK3335065 is a solution and will be administered as intravenous injection and infusion with dose strength of 5 milligram (mg)/mL that may be diluted in 0.9% weight by volume (w/v) sodium chloride.
15952421|NCT03245619|Drug|Placebo|Placebo solution to match GSK3335065 will be given as intravenous injection and infusion.
15952422|NCT03245606|Procedure|Liver biopsy|Measurement of liver fibrosis
15952423|NCT03245606|Device|Abdominal MRI|Measurement of liver fibrosis
15952424|NCT03245606|Device|Transient elastography|Measurement of liver fibrosis
15952425|NCT03245593|Other|Shared-decision making process|Completion of the Ottawa Personal Decision Guide to help guide care with the support of online and printed material describing the therapeutic options available
15952426|NCT03245593|Other|standard care|Care of patients according to standard practice of managing patients with bipolar disorder
15952427|NCT03245580|Diagnostic Test|Core Liver Biopsy|Diagnostic EUS examination followed by liver biopsy to obtain core sample in benign liver disease.
15952428|NCT03245567|Other|PLM|Participants will take the PLM on the visual estimation of LVEF. They will also take a pretest, a post-test and a delayed test at 6 months.
15952429|NCT03245567|Other|Pre, post, delayed test|Participants will perform a pretest, a posttest and a delayed test at 6 months.
15952430|NCT03245554|Drug|Propranolol|0 or 1 were generated by using Random software. The patient entered the placebo group if number was 0; if the random number generated was 1, then entered the propranolol group.
15952431|NCT03245541|Drug|Durvalumab|Durvalumab will be given 750 mg, intravenously (IV) over 60 minutes (+/- 5 minutes), Q14 days beginning D1. Four doses of durvalumab will be administered on the Q14 day schedule. Subsequently Durvalumab will continue as maintenance 1500mg, intravenously (IV) over 60 minutes (+/- 5 minutes), Q28 days up to 1 year or until progression (11 doses), unacceptable toxicity or other reason. If a patient undergoes resection, they will resume durvalumab once appropriately healed from surgery (approximately 4-8 weeks) at discretion of treating medical oncologist.
15952432|NCT03245541|Radiation|Stereotactic Ablative Body Radiotherapy (SABR)|SABR delivered as 6.6 Gy/fraction x 5 fractions given within two weeks will be administered weekdays and will begin D8.
15952433|NCT03245528|Drug|LJPC-501|angiotensin II
15952434|NCT03245515|Drug|BMS-986195|specified dose on specified days
15952435|NCT03245502|Biological|Blood transfusion|The transfusion of erythrocyte suspension
15952436|NCT03245489|Drug|Pembrolizumab|200mg intravenous (IV) over 30 minutes
15952437|NCT03245489|Drug|Clopidogrel|75mg/day oral
15952438|NCT03245489|Drug|acetylsalicylic acid|81mg/day oral
15952439|NCT03245476|Other|Physical therapy focus on manual therapy and home-exercises|corticoid injection + physiotherapy with a focus on manual therapy and home-exercises
15952440|NCT03245476|Other|Physical therapy focus on education and supported home exercises|corticosteroid injection + physiotherapy with focus on education and supported home exercises
15952441|NCT03245463|Other|Educational handout|The educational handout will include information on self-management strategies.
15952442|NCT03245463|Other|Verbal script|The verbal script will include details on self-management strategies that will be reviewed with the patient.
15952443|NCT03245463|Drug|Hyaluronic Acid|All study patients are undergoing injections with hyaluronic acid prior to the administration of the teaching method. The injections are standard of care and are required as part of the inclusion criteria.
15952444|NCT03245450|Drug|Eribulin mesilate|IV infusion
15952445|NCT03245450|Drug|Irinotecan hydrochloride|IV infusion
15952446|NCT03245437|Drug|Oxytocin nasal spray|nasal spray
15952447|NCT03245437|Behavioral|Social Cognition Skills Training|Group based training in social cognition skills
15952448|NCT03245437|Behavioral|Health Management|Group-based training in mental health management
15952449|NCT03245437|Drug|Placebo nasal spray|placebo condition
15952450|NCT03245424|Drug|ivosidenib (AG-120)|Patients will receive ivosidenib 500 mg by mouth once daily on 28-day cycles
15952451|NCT03245411|Behavioral|Intervention|All participants in this group will receive the standard of care intervention provided by the RN. This includes:Education in the clinic setting,Printed information about the chemotherapy drug and chemotherapy side effects. The RN will be blinded to the arm of study to which each patient is allocated.
15952452|NCT03245398|Drug|Treatment with one of the two regimens of mebendazole|Once in the morning and once in the evening for 3 consecutive days
15952453|NCT03245385|Drug|Treatment with Halobetasol propionate 0.05% topical spray|Patients will be treated with topical halobetasol 0.05% spray applied twice daily for 14 days. Patients will be instructed not to rub over the affected area after application of spray. Each patient is expected to receive 28 doses. The maximum amount of test product applied per week will not exceed 50 g
15952456|NCT03245359|Device|Short-term ON-Q|single port, select-a-flow pump connected to saphenous nerve block catheter until medication in initial balls are depleted (usually 2-4 days)
15952457|NCT03245359|Device|Short-term ON-Q|single port, fixed flow pump connected to posterior knee catheter until medication in initial balls are depleted (usually 2-4 days)
15952458|NCT03245359|Drug|Short-term ON-Q|Bupivacaine 0.125%
15952459|NCT03245359|Device|Long-term ON-Q|single port, select-a-flow pump connected to saphenous nerve block catheter until day 7 post-operative
15952460|NCT03245359|Device|Long-term ON-Q|single port, fixed flow pump connected to posterior knee catheter until day 7 post-operative
15952461|NCT03245359|Drug|Long-term ON-Q|Bupivacaine 0.125%
15952557|NCT03244605|Drug|TCM|three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe.
15952464|NCT03245346|Drug|GA|General anesthesia will be maintained with inhalation (sevoflurane) and sufentanil infusion, and muscle relaxants will be administered when considered necessary.
15952465|NCT03245346|Drug|PCIA|Patient-controlled intravenous analgesia (1ug/ml sufentanil) will be provided after surgery.
15952466|NCT03245333|Drug|Recombinant Human Growth Hormone Injection|Stage 1：JINTOPIN AQ 0.2IU/kg/d（0.46mg/kg /wk）for 52 weeks.
15952467|NCT03245333|Drug|Recombinant Human Growth Hormone Injection|Stage 2: After completing phase 1, patients are administrated the appropriate dose of JINTOPIN AQ, the highest dose should be no more than 0.2IU/kg/d, from the 53rd weeks to the final height.
15952468|NCT03245320|Device|Integra TITAN™ Total Shoulder Generation 1.0|Total Shoulder Arthroplasty or Hemiarthroplasty
15952469|NCT03245307|Drug|Apatinib|Apatinib at a dosage of 750mg will be administered daily from day 9 of phase A
15952470|NCT03245307|Drug|Nifedipine GTIS|Nifedipine at a dosage of 30mg will be administered at day 1 and day 14 of phase A
15952471|NCT03245307|Drug|Warfarin Potassium|Nifedipine at a dosage of 3mg will be administered at day 3 and day 16 of phase A
15952472|NCT03245294|Procedure|lumbar epidural injection|the pattern of pressure decrease from ligamentum flavum to epidural space
15952473|NCT03245281|Drug|Diuretic Suspension (DS)|Stop diuretic consumption in the 48h before the follow-up visit
15952474|NCT03245281|Drug|Diuretic Increase (DI)|Double diuretics dosage in the 48h before the follow-up visit
15952475|NCT03245281|Drug|Diuretic and Medication Suspension (DMS)|Stop diuretic and MRA medication consumption in the 48h before the follow-up visit
15952476|NCT03245268|Procedure|Balloon pulmonary angioplasty|BPA is an interventional technique where a balloon catheter is used to recanalize affected segments of pulmonary arteries identified during angiography.
15952477|NCT03245255|Drug|Sonazoid|Whenever a patient undergoes cardiac catheterization, which routinely includes intracardiac pressure monitoring using a pressure catheter, as part of their standard clinical care and agrees to participate in the study, we will acquire research data. With Sonazoid infusion, SHAPE algorithm will be initiated to determine optimum acoustic pressure. Then, at the optimum acoustic pressure, SHAPE specific data will be acquired from the cardiac chambers and aorta synchronously with the pressures recorded by the catheter (as a part of the patient's standard of care). After acquiring the ultrasound imaging data, the remainder of the heart catheterization will be completed by the attending cardiologist according to the patients' standard of care.
15952478|NCT03245242|Other|Enhanced Recovery after Surgery|Enhanced Recovery After Surgery (ERAS) protocol is a multi-disciplinary program that aims to standardize care processes around the pre-, intra-, and post-operative care setting. This group will prospectively receive care under a pre-defined protocol.
15952479|NCT03245242|Other|Historical usual surgical care|"Recent historical controls will have received care under usual care that existed prior to implementation of an enhanced recovery protocol."
15952480|NCT03245229|Drug|ACT-132577|Capsule for oral administration
15952481|NCT03245229|Drug|Rosuvastatin|Tablet for oral administration
15952482|NCT03245216|Behavioral|aerobic exercise|Single-bout of moderate intensity aerobic exercise on a cycle ergometer before motor learning
15952483|NCT03245216|Behavioral|rest|Seated rest before motor learning
15952484|NCT03245216|Behavioral|motor learning|Motor learning task on a stability platform (Stabilometer). Participants try to keep the tiltable platform in an horizontal position.
15952485|NCT03245203|Procedure|FOLFIRI+beacizumab|Eligible patients received bevacizumab 5.0 mg/kg followed by irinotecan 125mg/m2 combined with LV 200mg/m2 followed by 5-FU bolus 400mg/m2,then 5-FU infusion 2.4~3.0g/m2 over a 46-h period.Those agents were given for a 2-week cycle.Treatment was administered for six cycles. LARC was reevaluated and operated after 4~8 weeks.
15952486|NCT03245203|Procedure|CRT|total dose of radiotherapy was 40~50Gy, a subdose of 1.8~2Gy for continuous 5 weeks, 5 times/week.Then,5-FU infusion 400mg/m2 combined with LV 200mg/m2 over 24 h for 4 days/week during the first and fifth weeks of radiotherapy.Whereas,Capecitabine was administered orally at a dose of 825mg/m2 twice a day for 5 days of a week. Second staging and operation were performed in the sixth week after chemoradiotherapy.
15952487|NCT03245190|Drug|Chiauranib|50mg, orally once daily
15952488|NCT03245177|Biological|Pembrolizumab|Anti-PD-1 antibody
15952489|NCT03245177|Radiation|Radiotherapy|60-66 Gy in 30-33 fractions, 2 Gy per fraction
15952490|NCT03245164|Other|Physiotherapy group exercises|Physiotherapy exercises had aerobic, balance, strength exercises with music.
15952491|NCT03245164|Other|Basketball program|Basketball education presented the techniques about playing basketball and basketball games were played.
15952492|NCT03245151|Drug|Lenvatinib|oral hard capsules containing 1 mg, 4 mg, or 10 mg lenvatinib, or an extemporaneous suspension
15952493|NCT03245151|Drug|Everolimus|2 mg, 3 mg, or 5 mg tablets for oral suspension
15952494|NCT03245138|Procedure|Endoscopic Third Ventriculostomy|patients receive an endoscopic third ventriculotomy as surgical procedure
15952495|NCT03245138|Procedure|Ventriculo-Peritoneal Shunting|patients receive an ventriculo-peritoneal shunt as surgical procedure
15952496|NCT03245125|Behavioral|High-intensity interval training|Patients warmed up for 3 min at 30% of peak oxygen consumption (VO2peak). Five 3-minute intervals at 80% of VO2peak and each interval was separated by 3-minute exercise at 40% of VO2peak. The exercise session was terminated by 3-minute cool-down at 30% of VO2peak. All subjects used a EKG and BP monitors as indicators of the assigned exercise intensity. Borg 6-to-20 scale was used to assess the rate of perceived exertion during and after each exercise session. Patients suffering unstable hemodynamic, ischemic cardiac symptoms/signs, and uncontrolled arrhythmia were instructed to immediately terminate exercise training.
15952497|NCT03245112|Drug|Eribulin Mesylate|The patients received intravenous eribulin 1.4 mg/m2 over 2-5 minutes on days 1 and 8 of every 21 days.
15952498|NCT03245099|Other|cross sectional|Electroencephalograph will be done to all patients who fulfill the inclusion criteria to detect presence of electrical discharge with in the brain.Complete blood count ,liver function test ,kidney function test ,blood glucose level and serum electrolytes will be done to selected cases according to the clinical presentation
15952558|NCT03244605|Drug|placebo|three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe，with the same color, smell，taste weight and package
15952559|NCT03244592|Drug|Minocycline|200 mg/day
15952560|NCT03244592|Drug|Sugar pill|Matched placebo
15952499|NCT03245086|Device|Transanal hemorrhoid dearterialization|The hemorrhoids are operated in their natural position and not distorted by eversion The proctoscope is fully introduced transanally to reach the lower rectum. Under Doppler guidance, six arterial signals are found circumferentially above the dentate line. The approach to make the 'dearterialization' involves the transfixation of the rectal mucosa and submucosa to entrap the artery using a suture. Mucopexy is performed after the artery ligation with the same suture used for the dearterialization. Finally, the suture is tied to fix the mucopexy.
15952500|NCT03245086|Procedure|Ferguson hemorrhoidectomy|The hemorrhoids are operated in their natural position and not distorted by eversion. A Ferguson-Hill retractor is used to expose the hemorrhoids. Dissection with scissors is directed up to the dentate line where the fibers of the sphincter muscles are exposed and only a mucosal pedicle remains attached. A Buie-Smith crushing clamp is applied to this pedicle and the hemorrhoidal mass is excised at the superior level of the clamp. The pedicle is then ligated and the crushing clamp is removed. After dissection of the intermuscular septum is complete, the margins of the wound are drawn upward into the anal canal with stitches and are secured to the pedicle by the same suture. The remainder of the wound is closed with a stitch tied at the outer extremity of the wound using the same suture.
15952501|NCT03245073|Other|Action observation therapy|The normal human movement will be recorded and than the patients will be watched them.
15952502|NCT03245073|Other|Exercise|Strengthening and stretching exercise programme focuses on hip and knee muscles
15952503|NCT03245060|Behavioral|Adapted Solution Focused Brief Therapy|Solution Focused Brief Therapy is an approach to building positive change in a person's life. It builds up a picture of a client's preferred future (or how a person would like their life to be); encourages a person to notice positive signs of change; and explores personal resources, skills and resilience. In the present project, the therapy has been adapted so that it works well with people who have a language disability.
15952504|NCT03245047|Dietary Supplement|Oral Nutritional Supplement with AN 777|Oral Nutritional Supplement with AN 777, 2 servings a day
15952505|NCT03245047|Other|Oral Nutritional Supplement|Oral Nutritional Supplement, 2 servings a day
15952506|NCT03245034|Behavioral|Auricular Acupuncture Therapy|"Acupuncture treatment will be the NADA protocol, a well-known and commonly used protocol that has previously been studied for stress relief in health care workers.In this protocol, 5, ½ needles are inserted in each auricle and retained while the group relaxes for 20 minutes. It will be conducted by two acupuncturists credentialed at NYU Lutheran (TK and AG)."
15952507|NCT03245021|Drug|Opdivo|"All patients will receive:
~Nivolumab 240mg IV q2-weekly for four cycles
~Patients in complete remission (CR):
~Nivolumab 240mg IV q2-weekly for four further cycles (8 in total)
~Patients with partial response (PR), stable disease (SD), asymptomatic or minor progressive disease (PD) post 4cycles receive:
~Nivolumab 240mg IV plus rituximab 375mg/m2 IV q2-weekly for four cycles
~Patients in CR:
~Nivolumab 240mg IV q2-weekly for four further cycles (8 in total)
~Patients with PR, SD, asymptomatic or minor PD post 4 cycles receive:
~Nivolumab 240mg IV plus rituximab 375mg/m2 IV q2-weekly for four cycles"
15952508|NCT03245008|Drug|MT-5547|Solution for injection in pre-filled syringe
15952509|NCT03245008|Drug|MT-5547-matching placebo|Solution for injection in pre-filled syringe
15952510|NCT03244995|Procedure|Mind-Body Intervention Procedure|Undergo CBMB program
15952511|NCT03244995|Other|Quality-of-Life Assessment|Ancillary studies
15952512|NCT03244995|Other|Questionnaire Administration|Ancillary studies
15952513|NCT03244982|Drug|Fluorescein Na 10% Inj 500mg|Full-dose intravenous Fluorescein Na prior to fluorescein angiography.
15952514|NCT03244982|Drug|Fluorescein Na 10% Inj 250mg|Half-dose intravenous Fluorescein Na prior to fluorescein angiography.
15952515|NCT03244956|Drug|Trametinib|2mg daily for a maximum of 6 weeks of treatment
15952516|NCT03244956|Drug|Dabrafenib|150mg twice daily
15952517|NCT03244956|Radiation|131I|5.5 GBq
15952518|NCT03244956|Drug|rhTSH|0.9mg on two consecutive days after 35 days of treatment
15952519|NCT03244943|Procedure|Non surgical periodontal Treatment|The NSPT, which consisted of subgingival debridement - scaling and root planning (SRP) under local anesthesia. On average, the treatment of the entire oral cavity was completed within four sessions (sessions of 50 minutes). The SRP was performed by one experienced periodontist (KRVV) using Gracey curettes (Hu-Friedy MFG. Co. Inc., Chicago, IL, USA), ultra-sonic devices (Bob-Cat, Dentsply/Cavitron, Long Island City, NY, USA) and, if necessary, with multilaminated drills.
15952520|NCT03244930|Drug|Plerixafor 0.12 mg/kg|Subcutaneously G-CSF 10 mg/kg for 4 days. At day four SC plerixafor 0.12 mg/kg as a single dose 11 hours prior to initiation of aphaeresis.
15952521|NCT03244917|Behavioral|TRAIN-AD|The study intervention is a multi-component training and education program targeting direct care providers and healthcare proxies for advanced dementia NH residents, intended to improve the management of urinary and lower respiratory tract infections in advanced dementia patients. There are two components to this practice intervention: 1. Provider Training, and 2. Proxy Education. Intervention components aimed at the provider include: Professionally led infection management training seminars, online infection management course, and infection management guidance algorithms. Additionally participating prescribing providers will be sent bimonthly infection management feedback reports. Proxy Education is completed by providing an infection management in Advanced Dementia booklet to proxies of patients with AD upon resident enrollment in study.
15952522|NCT03244891|Other|Increase of central volume|"Mild hypovolemia will be induced in healthy volunteers by 12 hours fasting. Three conditions will be considered for the analysis, each of them both during spontaneous breathing and positive pressure ventilation:
~baseline
~after fluid shift induced by passive head down position at 15 degrees
~after fluid challenge with Ringer acetate 15ml*kg in head down position
~A total of six steps will be considered for the analysis"
15952523|NCT03244891|Other|Ventilation mode|"Each previous step will be done in two respiratory conditions:
~spontaneous breathing
~noninvasive ventilation via facial mask in pressure support mode at 8 cmH2O above positive end expiratory pressure of 5 cmH2O, inspiratory fraction of oxygen of 0.25 In both conditions respiratory rate will be set at 18 breaths per min following a metronome"
15952524|NCT03244878|Behavioral|Thrive|A interactive computerized program using structured content of cognitive behavior therapy
15952561|NCT03244579|Behavioral|Dietary Intervention|Adjusting the quantity and quality of food intake to improve glycemic control, maternal and newborn health outcomes of women with gestational diabetes.
15987635|NCT02981069|Drug|Placebo|Placebo for Dapagliflozin
15952525|NCT03244865|Device|LaborView Electronic Fetal Monitor|"Per LaborView directions, electrode application sites will be prepared to reduce skin impedance, electrodes will be applied to the maternal abdomen and FHR data acquired for comparison with CTG data obtained through the traditional monitoring system. The comparison will be performed off-line.
~Nothing is required of the subjects. They will be non-invasively monitored for one to several hours. The information obtained will not be used for medical decision-making and there is no significant risk to the patient or her fetus."
15952526|NCT03244839|Procedure|bariatric surgery|bariatric surgery
15952527|NCT03244826|Other|Shared Care|Shared Care involves four specific strategies to allow patients to have a portion of their care locally after HCT, where clinic and laboratory visits are equally shared between the local oncologist and primary HCT team
15952528|NCT03244826|Other|Standard Care|The usual care provided by the transplant center at DFCI.
15952529|NCT03244813|Other|Personalized activity program|Targeted physical activity
15952530|NCT03244800|Drug|MEDI0382|MEDI0382 will be administered subcutaneously once daily for 49 days.
15952531|NCT03244800|Drug|Placebo|Placebo will be administered subcutaneously once daily for 49 days.
15952532|NCT03244787|Behavioral|patient navigation|Current standard of care is for PNs to work with patients from health centers who are referred by providers. Intervention patients will appear on a PN list without any referral by providers. Control high risk patients will proceed normally and will be eligible to transfer to a PN list after the 6-month study period.
15952533|NCT03244774|Drug|Apatinib|"Apatinib 250mg p.o. qd in first cohort (3 subjects). 375mg p.o. qd in second cohort (3 subjects). 500mg p.o. qd in third cohort (3 subjects). 625mg p.o. qd in forth cohort (3 subjects); 750mg p.o. qd in fifth cohort (3 subjects).
~Other Name:"
15952534|NCT03244774|Drug|POF|The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days.
15952535|NCT03244761|Procedure|The modified HFT|The HFT was modified by increasing the expiratory resistance.
15952536|NCT03244748|Procedure|Ventricular tachycardia ablation|Electrophysiologic procedure aims to ablate and terminate arrhythmia percutaneously
15952537|NCT03244735|Other|Atkins diet|A nutritional regimen characterized by high fat low carbohydrate intake.
15952538|NCT03244722|Dietary Supplement|Very-low energy Diet (VLED)|Structured, intensive dietary intervention using liquid meal replacements aimed at providing 800 kcal/day with a weight loss goal of 15% from baseline
15952539|NCT03244722|Other|Standard of care (SOC)|Standard consultation with registered dietitian to determine appropriate caloric deficit for a low calorie diet, education and advice to achieve weight loss in obese women. Standard of care for normal weight women
15952540|NCT03244709|Drug|Tocilizumab|Intravenous Tocilizumab followed by subcutaneousTocilizumab
15952541|NCT03244696|Behavioral|Step Tracking|The step tracking intervention is designed to increase physical activity through the use of self-monitoring and brief motivational materials. The motivational materials will be delivered at various points during the intervention. Participants are not required to access and read these materials, however, the hope is these materials will aid in study and goal adherence. Engagement in the intervention will be tracked by the experimenters using the behavioral data gathered by the tracker.
15952542|NCT03244696|Behavioral|Water Tracking|The water tracking intervention is designed to increase water intake, to a healthy level, through the use of self-monitoring and brief motivational materials.The motivational materials will be delivered at various points during the intervention. Participants are not required to access and read these materials, however, the hope is these materials will aid in study and goal adherence. Engagement in the intervention will be tracked by the experimenters using the behavioral data gathered by the tracker.
15952543|NCT03244683|Dietary Supplement|Ensure Surgical|Subjects randomized to the intervention arm will consume two Ensure Surgical for 5-7 days.
15952544|NCT03244683|Other|Nutrition counseling|All study subjects will be provided with nutrition counseling at the time of study enrollment.
15952545|NCT03244683|Other|Low-intensity exercise therapy|Patients randomized to the intervention arm will also be provided with verbal and written instructions for light resistance training. The exercises will be performed at home during the preoperative study period.
15952546|NCT03244670|Other|Observation study only, no specific intervention|Observation study only, no specific intervention
15952547|NCT03244657|Drug|conbercept ophthalmic injection （0.5mg）|"The target eye receives intravitreal injection of 0.5mg conbercept ophthalmic injection once every 12 weeks; if a subject meets additional drug administration criteria within 12 weeks between treatments, the subject can receive additional injection treatment"
15952548|NCT03244657|Drug|conbercept ophthalmic injection （0.5mg）|"In principle, the first administration time of the target eye uses the time determined by the assessment at end of STAR study; later, based on treatment-extension drug administration criteria, an investigator determines next visit time/treatment interval according to assessment result at each visit.When a subject's visit/treatment interval extends to 12 weeks, an additional safety visit can be arranged if an investigator considers that there is suspicious active lesion; if assessment result at the safety visit meets additional drug administration criteria, additional injection treatment can be given."
15952549|NCT03244644|Drug|RBX2660|RBX2660 is a microbiota suspension administered as an enema
15952550|NCT03244644|Drug|Placebo|Placebo is normal saline solution administered as an enema
15952551|NCT03244631|Procedure|Lumbar Plexus BLock|Peripheral nerve block
15952552|NCT03244631|Procedure|Pericapsular injection|Injection around the area undergoing surgery
15952553|NCT03244618|Device|CSSP Toothpaste|Toothpaste containing calcium silicate, sodium phosphate and sodium monofluorophosphate
15952554|NCT03244618|Device|Fluoride Toothpaste|Toothpaste containing sodium monofluorphosphate
15952555|NCT03244605|Other|Rehabilitation Training|Patients will be trained in one month after operation. Rehabilitation training include aerobic exercise training (using cycle ergometer for 7-14 times at all, once a day, 15-20 min/time and using treadmill for 7-14 times at all, once a day, 15-20 min/time according to the patient's endurance) and Liu Zi Jue lung exercises, which strengthen the lung function of the human body in Chinese traditional health culture, five times a week, 15 min/time.
15952556|NCT03244605|Other|Rehabilitation Education|General health education
15952562|NCT03244566|Diagnostic Test|positron emission tomography|patients who had esophagectomy with 3-field lymphadenectomy underwent examination of positron emission tomography prior to surgery within 2 weeks.
15952563|NCT03244553|Drug|Prucalopride|5 day treatment
15952564|NCT03244540|Procedure|TAP (transversus abdominis plane block)|ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain
15952565|NCT03244540|Procedure|QLB (quadratus lumborum block)|ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain
15952566|NCT03244540|Device|Stimuplex Ultra 360 needle|ultrasound-guided needle will be used for QLB and TAP and regional blocks
15952567|NCT03244540|Drug|Ropivacaine|0.375 % ropivacaine will be administered for both QLB and TAP (0.2 mL per kg on both sides)
15952568|NCT03244540|Drug|Paracetamol|Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day
15952569|NCT03244540|Procedure|subarachnoid anesthesia|subarachnoid anesthesia for each patients participating in the study with pencil point needle
15952570|NCT03244540|Procedure|PCA (patient controlled analgesia)|All patients will receive PCA pump with morphine (1 mg/mL, 5 minute interval, no loading dose) after transfer to PACU (post-anesthesia care unit)
15952571|NCT03244540|Drug|Metamizol|Intravenous metamizol will be used (1.0 gram), up to 4 grams per day
15952572|NCT03244540|Drug|Ketoprofen|Intravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day
15952573|NCT03244540|Drug|Bupivacaine|Subarachnoid anesthesia with spinal bupivacaine (MARCAINE SPINAL 0.5% HEAVY)
15952574|NCT03244527|Dietary Supplement|BCAA supplement|Before each exercise session (described later), the research assistant will give subjects 40g of BCAA or placebo supplement according to the treatment assignment and ask them to drink it down right away.
15952575|NCT03244527|Other|Aerobic exercise|The exercise intervention includes 24 aerobic stationary cycling sessions (30 min/session, 3 session/week, and 8 weeks). The exercise sessions proceed under the supervision and guidance of a therapist.
15952576|NCT03244514|Other|Intervention|Implementation of the cardiovascular AKI bundle (see arm description)
15952577|NCT03244501|Other|Active tSMS|A cylindrical neodymium magnet is placed above the scalp.
15952578|NCT03244501|Other|Sham tSMS|A cylindrical piece of nonferrous metal (brass). This is not attracted to magnets, and is identical in weight and appearance to active magnets.
15952579|NCT03244488|Drug|Scopolamine Injectable Product|2.5 or 5 mcg/kg of scopolamine via IV
15952580|NCT03244488|Drug|Mecamylamine Pill|10 or 20mg of mecamylamine orally
15952581|NCT03244475|Device|IASIS Micro Current Neurofeedback|The EEG interface device is the J&J Engineering I-330 C2, provided specifically for IASIS. The EEG sampling frequency is 256 Hz on each of 2 EEG acquisition channels. The feedback LIP-tES is delivered via the 4 EEG leads (A+, A-, B+, B-), with respect to the Common Neck Reference (isolated). During each session, 2 electrodes (A- and B-) are attached to the participant's left and right mastoids, while the remaining two electrodes (A+ and B+) are moved to various locations on the scalp to record EEG signals. All four (A+, A-, B+, B-) electrodes are involved in applying weak electric current pulses back to the brain (the feedback process). The feedback signal consists two types of narrow pulse trains, both with 150 mV in amplitude: A Type 1 pulse is 25 ms in duration and contains carrier waves at ~50 KHz. The repetition rate of Type 1 pulse train is fixed at 3.6 Hz; A Type 2 pulse is 120 ns in duration and contains carrier waves at ~100 MHz.
15952582|NCT03244475|Device|Nexalin|The Nexalin device, FDA clearance (501K=K024377, Classification: Stimulator, Cranial Electrotherapy: CFR 882. 5800: U.S. Patent #6904322B2), produces a waveform that provides tES to the brain delivered at a frequency of 77.5 Hz at 0 to 4 mA peak current. There is evidence that this waveform, at this frequency, results in improved clinical outcomes in terms of anxiety and pain. The specific mechanisms of action are not known, but available evidence suggests that this waveform alters the function of the hypothalamus and related structures. In particular, tES may lead to increases in levels of enkephalins and beta-endorphins in brain and CSF. Other data suggest that tES can alter endogenous levels of both substance P and serotonin. Regardless of which neuropeptide or neurotransmitter is ultimately found to be modulated by tES, it is hypothesized that repeated TES treatments over time serve to stimulate long-term neurochemical changes.
15952583|NCT03244462|Drug|BAY1834845|Single oral dose (IR [immediate release] tablets)
15952584|NCT03244462|Drug|BAY1834845|I.v. infusion of [13C6]-labeled BAY1834845
15952585|NCT03244462|Drug|Methotrexate|Single dose of commercially available MTX
15952586|NCT03244449|Other|No apply|
15952587|NCT03244436|Procedure|Surgery following catheterization|Emergency surgery following pediatric cardiac catheterization
15952588|NCT03244423|Drug|Normal saline at induction|0.5 ml/kg
15952589|NCT03244423|Drug|Normal saline infusion|1ml/kg/hr. during surgery for six hours
15952590|NCT03244423|Drug|Intravenous tranexamic acid|50 mg/kg
15952591|NCT03244423|Drug|infusion tranexamic acid|1mg/kg/hr infusionfor 6 hours
15952592|NCT03244423|Drug|topical tranexamic acid|50 mg/kg added to the normal saline 2 ml/kg into the pericardial cavity before sternal closure
15952593|NCT03244423|Drug|topical normal saline|2 ml/kg into the pericardial cavity before sternal closure
15952594|NCT03244410|Diagnostic Test|complete blood picture|complete blood picture
15952595|NCT03244397|Other|Physical therapy + educational strategy|See arm/group descriptions
15952596|NCT03244397|Behavioral|Educational strategy|See arm/group descriptions
15952597|NCT03244384|Other|Clinical Observation|Undergo observation
15952598|NCT03244384|Other|Laboratory Biomarker Analysis|Correlative studies
15952599|NCT03244384|Biological|Pembrolizumab|Given IV
15952600|NCT03244384|Other|Pharmacological Study|Correlative studies
15952601|NCT03244384|Other|Quality-of-Life Assessment|Ancillary studies
15952602|NCT03244384|Other|Questionnaire Administration|Ancillary studies
15952603|NCT03244371|Other|blood draw|4 blood draws of 25 mls of blood will be performed at 4 differents time points (before treatment, 4 weeks later, at the end of the treatment and 6 months after the end of the treatment)
15952604|NCT03244358|Drug|Epalrestat|Epalrestat 50mg tid added to standard chemotherapy treatment
15952605|NCT03244345|Behavioral|Self-measurement scale of sensitivity to stress/emotion|Patient will answer self-questionner on Depression
15953910|NCT03234296|Other|Placebo|Intravenous placebo followed by per oral placebo
15952606|NCT03244332|Other|Collecting Clinical Data|Clinical data as height, weight, mid upper arm circumference, jaundice, portal hypertension signs (ascites, splenomegaly, umbilical veinous circulation)
15952607|NCT03244332|Other|Collecting laboratory data|Laboratory data as CRP, hemogram, albumin, total and conjugated bilirubin, creatinin, urea, liver enzymes, tests of hemostasis.
15952608|NCT03244319|Drug|Edoxaban|Patients who are randomly assigned to edoxaban group will be received 60mg qd or 30mg qd (creatinine clearance 30-49ml/min, body weight <60kg or concomitant use of certain P-glycoprotein inhibitors).
15952609|NCT03244319|Drug|Warfarin|All patients who are assigned to VKA group, bridging with warfarin and UFH is mandatory until INR reach therapeutic target range (INR 2-3). Warfarin dose will be adjusted for maintain therapeutic range (INR 2-3) during follow up period.
15952610|NCT03244319|Drug|parenteral anti-coagulant (UFH)|parenteral anti-coagulant (UFH)
15952611|NCT03244306|Biological|Patient-derived CD22-specific CAR T-cells also expressing an EGFRt|Patient-derived CD22-specific chimeric antigen receptor T-cells expressing an EGFRt
15952612|NCT03244293|Other|no intervention|
15952613|NCT03244280|Drug|MOB015B|Topical formulation
15952614|NCT03244267|Behavioral|Standard Education|Participants will receive the usual verbal education and printed information provided to patients about the importance of taking aspirin to prevent thromboembolic events after orthopedic surgery, medication dosage and scheduling.
15952615|NCT03244267|Behavioral|Medication Reminder App|Participants will use a medication reminder app that is set in collaboration with the participants for times that fit into their daily lifestyle. The app will alert participants when it is time (selected by the participant) to take their medication.
15952616|NCT03244241|Drug|Insulin Degludec 100 UNT/ML [Tresiba]|Basal-bolus insulin regime
15952617|NCT03244228|Drug|HTL0016878|Oral solution
15952618|NCT03244228|Drug|Placebo - Concentrate|Matching placebo
15952619|NCT03244215|Diagnostic Test|Corneal Confocal Imaging|Retinal imaging will be ordered for all subjects in the study group. Corneal
15952620|NCT03244215|Diagnostic Test|Magnetic resonance Imaging|MRI will be ordered for all study subjects at the completion of their participation at year 1. The MRI will assess the the progression or regression of the cerebrovascular health of the study subjects.
15952621|NCT03244215|Other|Blood sample|Blood samples will be obtained to evaluate the levels of blood inflammatory biomarkers in both the subjects and control group.
15952622|NCT03244202|Other|Decision Aid Plus Counselling|The Genomics ADViSER is an decision aid designed to inform patients about genomic sequencing (GS) and aid them selecting which incidental findings they would like to receive from GS.
15952623|NCT03244202|Other|Genetic Counselling Only|Participants will learn about genomic sequencing and incidental findings by speaking directly with a genetic counsellor and select which incidental findings they would like to receive with a genetic counsellor.
15952624|NCT03244189|Behavioral|Fluid prescription|The additional amount of fluid that the participant will need to consume each day, using the smart water bottle, in order to meet the study-specified urine output. This fluid is in addition to any other sources of fluid (ex. cups of coffee, bottled sports drink) that the participant consumes each day.
15952625|NCT03244189|Behavioral|Financial incentive|Participants in the Intervention Arm who meet their fluid intake goal on randomly selected days will receive a small payment for that day.
15952626|NCT03244189|Behavioral|Structured Problem Solving|Structure Problem Solving involves interactions with health coaches to help participants develop feasible solutions to overcoming personal barriers to maintaining the prescribed fluid intake.
15952627|NCT03244176|Drug|Avelumab|"All participants will receive the following treatment:
~Induction phase Avelumab at a dose of 10 mg/kg as a 1hour intravenous (IV) infusion once every 2 weeks for 2 cycles Plus Rituximab at a dose of 375mg/m2 as an IV infusion over at least 1 hour once every 2 weeks for 2 treatments
~Then:
~RCHOP - All participants will receive RCHOP chemotherapy treatment for 6 cycles. Each cycle will last for 21 days. Rituximab, cyclophosphamide, doxorubicin, and vincristine are given on the first day of each cycle by intravenous infusion. Prednisone is given orally from Day 1 until Day 5 of each cycle.
~Then:
~Maintenance phase - All participants will receive Avelumab at a dose of 10 mg/kg as a 1hour intravenous (IV) infusion once every 2 weeks for 6 cycles."
15952628|NCT03244163|Device|Spyglass DS cholangioscope|The 1.8Fr holmium:YAG laser fiber (Lumenis, Yokneam, Israel) will be inserted into the cholangioscope's working channel for lithotripsy under direct visualization. An EHL probe may alternatively be used depending on availability. Lithotripsy is applied until fragments of the targeted stone are no longer lumen filling, and can be dispersed easily with fluid irrigation. Fragmented stones are then removed by a combination of conventional techniques. To confirm stone clearance, the Spyglass DS cholangioscope will be re-introduced, and the bile duct will be examined for residual stones from the confluence of the right and left intrahepatic ducts to the papillary opening
15952629|NCT03244163|Device|BML|Biliary sphincterotomy with/without EPBD to the size of the lower bile duct with a limit of 15mm will be performed. Stones are removed by a combination of conventional BML, extraction balloon and/or baskets, without laser lithotripsy. An occlusion cholangiogram is performed to confirm stone clearance. In cases where stone clearance is incomplete, a plastic biliary stent bridging the stone will be inserted for temporary drainage until definitive management, usually within one month.
15952630|NCT03244137|Other|Pulmonary rehabilitation|See group description.
15952631|NCT03244124|Other|Self-Etching Application Strategy|In Group SET, the adhesive system Futurabond Universal will be used in 50 teeth, according to the manufacturer's instructions, in the self-etching mode. The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and activated during 10 seconds with LED light; After applying the adhesive, the restorations will be made with composite Admira Fusion (VOCO GmbH, Germany), and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores.
15952632|NCT03244124|Other|Enamel Etching Application Strategy|In Group SEE, 37% phosphoric acid will be applied during 30 seconds, only in enamel in 50 teeth. This acid will be removed using water, the cavity will be air-dried, and then, the adhesive system Futurabond Universal will be used in 50 teeth, according to the manufacturer's instructions. The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and activated during 10 seconds with LED light; After applying the adhesive, the restorations will be made with composite Admira Fusion (VOCO GmbH, Germany), and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores.
15952633|NCT03244124|Other|Etch&Rinse Dry Application Strategy|In Group ERDry, 37% phosphoric acid will be applied during 30 seconds, only in enamel, and 15 seconds, only in dentin, in 50 teeth. This acid will be removed using water, the cavity will be air-dried, keeping dentin dry (but not overdry) and then, the adhesive system Futurabond Universal will be used in 50 teeth, according to the manufacturer's instructions. The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and activated during 10 seconds with LED light; After applying the adhesive, the restorations will be made with composite Admira Fusion (VOCO GmbH, Germany), and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores.
15952634|NCT03244124|Other|Etch&Rinse Wet Application Strategy|In Group ERWet, 37% phosphoric acid will be applied during 30 seconds, only in enamel, and 15 seconds, only in dentin, in 50 teeth. This acid will be removed using water, the cavity will be air-dried, keeping dentin wet and then, the adhesive system Futurabond Universal will be used in 50 teeth, according to the manufacturer's instructions. The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and activated during 10 seconds with LED light; After applying the adhesive, the restorations will be made with composite Admira Fusion (VOCO GmbH, Germany), and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores.
15952635|NCT03244111|Behavioral|simple memory tool|The goals may be implemented using the simple memory tool. Simple memory tool involves using materials such as checklists or diaries to assist with memory.
15952636|NCT03244098|Behavioral|Transition Assistance Program|TAP caregivers will receive an SCI caregiving guidebook, a 1-hour intervention session by an SCI clinician before hospital discharge, and four 1-hour telehealth clinic-to-home visits at 1, 2, 4, and 6 weeks after discharge by the same clinician
15952637|NCT03244085|Drug|QL-007 tablet|Patients will be enrolled in 1 of 3 cohorts (6 patients per cohort): QL 007 200 mg/day (100 mg BID), or QL 007 400 mg/day (200 mg/BID), or QL 007 600 mg QD. QL 007 will be administered orally daily over the 28 days under fasted state. Patients fast for 2h before administration and 1h after administration.
15952638|NCT03244072|Drug|Moxifloxacin|Intracameral injection
15952639|NCT03244072|Drug|Placebo|intracameral injection
15952640|NCT03244059|Biological|Belimumab|Belimumab is an anti-BLyS (B-lymphocyte stimulating factor) agent administered by infusion.
15952641|NCT03244059|Drug|Placebo|An identically appearing placebo infusion.
15952642|NCT03244046|Behavioral|Psychotherapy|The SE intervention followed the nine-step model as outlined by Peter Levine (2010) and involved gradually eliciting awareness of body sensations associated with the traumatic event. By the process of 'titration', patients were gradually encouraged to access somatic activation, feelings and body sensations as means to restore equilibrium to the autonomic nervous system and thereby alleviate hyperarousal, re-experiencing and avoidance of trauma-related experiences and thoughts.
15952643|NCT03244046|Behavioral|Physiotherapy|This treatment consisted of supervised exercises for low back pain delivered in 12 sessions and performed by physiotherapists in the center according to the European guidelines for the management of chronic low back pain (Airaksinen, et al., 2006).
15952644|NCT03244033|Other|Contextual clinical decision support|Incorporation of contextual data into EHR clinical decision support alerts
15952645|NCT03244033|Behavioral|Contextual survey|Patients complete a survey asking about red flags that could signal contextual factors relevant to their care
15952646|NCT03244020|Drug|Aspirin 325mg|Aspirin 325 mg by mouth once daily
15952647|NCT03244020|Drug|Enoxaparin 40Mg/0.4mL Prefilled Syringe|Enoxaparin 40 mg subcutaneous injection once daily
15952648|NCT03244007|Procedure|Vitrectomy|
15952649|NCT03243994|Diagnostic Test|Absorption test with D-xylose and zink|Absorption of D-xylose (25 g) and zinc (132 mg), administered as a single dose. The concentration of D-xylose and zinc was measured in peripheral blood one, two and three hours after ingestion and used as markers of absorption. Furthermore, urine was collected for five hours to determine the amount of excreted D-xylose.
15952650|NCT03243981|Device|Sciton SkinTyte (800-1800 nm) with Broadband Light Technology|This device has been used in the clinical setting to reduce cheek and submental laxity. SkinTyte delivers sequentially pulsed light (800-1200 nm, with a filter enabling focus on 590 nm) and broadband light (which can be turned on or off).
15952651|NCT03243955|Device|Verum TEAS|TENS unit with electrodes applied to acupuncture point locations
15952652|NCT03243955|Device|Sham TEAS|TENS unit with electrodes applied to non-acupuncture point locations
15952653|NCT03243942|Drug|Definity|Whenever a patient undergoes cardiac catheterization, which routinely includes intracardiac pressure monitoring using a pressure catheter, as part of their standard clinical care and agrees to participate in the study, we will acquire research data. With Definity infusion, SHAPE algorithm will be initiated to determine optimum acoustic pressure. Then, at the optimum acoustic pressure SHAPE specific data will be acquired from the cardiac chambers and aorta synchronously with the pressures recorded by the catheter (as a part of the patient's standard of care). After acquiring the ultrasound imaging data, the remainder of the heart catheterization will be completed by the attending cardiologist according to the patients' standard of care.
15952654|NCT03243929|Behavioral|Translation of District Sun Safe Policies to Schools|Translation of District Sun Safe Policies to Schools intervention was guided by Diffusion of Innovation Theory. Principals and other staff in intervention schools received 1) initial coaching meeting that guided principals through an evaluation of current sun safety practices, the selection of goals for the implementation of sun safety practices, and guidance on the use of intervention materials to support implementation of sun safety practices in the school, 2) follow-up communications from coaches including email, telephone, and virtual meetings, 3) access to media and online resources to support implementation of sun safety practices, 4) mini-grants to support changes in school sun safety practices. These components promoted implementation of the 10 policy components recommended by CDC.
15952655|NCT03243929|Behavioral|Attention Control|Schools in the control condition received three emails during the 20 month intervention period including (1) NASBE's Fit Healthy and Ready to Learn; A School Health Guide Part II: Policies to Promote Sun Safety and Prevent Skin Cancer, (2) CDC's Guidelines for Sun Safety to Prevent Skin Cancer, and (3) a link to the Surgeon General's 2014 Call to Action to Prevent Skin Cancer. This attention-control treatment will equalize schools on awareness of recommendations to implement school sun safety.
15953135|NCT03240185|Behavioral|deep breathing exercises|Patients receive education on deep breathing exercises for pain control as part of their pre-operative appointment
15952656|NCT03243916|Radiation|TACE plus Cyber knife|Patients with histologically confirmed MHCC(Massive Hepatocellular Carcinoma) will receive TACE therapy,after 1 or 2 week's recovery from hepatic insufficiency ,the targeted and staged cyber knife will be given
15952657|NCT03243903|Device|QS-M insulin-free injector|Using QS-M insulin-free injector as insulin carrier to control blood glucose of T2DM and insulin dose is prescribed.
15952658|NCT03243903|Device|conventional insulin pen|Using conventional insulin pen as insulin carrier to control blood glucose of T2DM and insulin dose is prescribed.
15952659|NCT03243890|Dietary Supplement|Menaquinone-7 720 µg/day including the recommended daily dose of vitamin D (25 µg/day).|Half of the patients are randomized to supplementation with MK-7 (720 µg/day) including the recommended daily dose of vitamin D (25 µg/day).
15952660|NCT03243890|Dietary Supplement|Placebo|Half of the patients are randomized to placebo treatment (no active treatment).
15952661|NCT03243877|Other|MammoAlert Screening Test|Plasma obtained from blood samples will be analyzed with the MammoAlert Screening Test for the presence of known breast cancer bio-markers.
15952662|NCT03243864|Drug|Ceftazidime-avibactam|Patients will be started on 2.5 gm IV every 8 hours
15952663|NCT03243851|Drug|Temozolomide+Metformin|Low dose temozolomide+metformin for 24 weeks
15952664|NCT03243851|Drug|Temozolomide+Placebo|Low dose temozolomide+placebo for 24 weeks
15952665|NCT03243838|Drug|Apatinib|docetaxel/carboplatin combined with apatinib as Neoadjuvant Treatment for Triple-Negative Breast Cancer
15952666|NCT03243825|Radiation|combination group|chemotherapy (paclitaxel/cisplatinum) and brachytherapy
15952667|NCT03243825|Drug|chemotherapy group|chemotherapy: (paclitaxel/cisplatinum)
15952668|NCT03243812|Biological|Blood sampling|Blood sampling will be performed to assess hematological and hemorheological parameters
15952669|NCT03243812|Other|Maximum Voluntary Contraction (MVC) test force|Maximum Voluntary Contraction (MVC) test force will be performed before and after a localized muscle endurance test
15952670|NCT03243812|Other|Localized muscle endurance test|Subject will perform 4 series of 20 submaximal dynamic contractions at 50% of the MVC interspaced with 1 min recovery.
15952671|NCT03243812|Other|Self-paced six-minute walk test|Self-paced six-minute walk test will be conducted according to the guidelines of the American Thoracic Society
15952672|NCT03243799|Behavioral|Group psychoeducation|Educational group sessions for patients with depression and physical comorbidities in order to improve the degree of control of their illnesses
15952673|NCT03243786|Behavioral|Lifestyle- Supportive Care|The intervention examines dietary and activity patterns, body composition, biomarkers and quality of life in breast cancer patients undergoing radiation therapy
15952674|NCT03243773|Other|Lung ultrasound|Point-of-care ultrasound exam of both lungs in 4 predefined zones.
15952675|NCT03243760|Drug|CCI15106 7.5 mg capsule|Orange capsule containing a white to off-white powder, 21.4 mg of CCI15106: Trehalose:Trileucine 35/55/10 weight by weight (w/w)
15952676|NCT03243760|Drug|Placebo|Orange capsule containing a white to off-white powder, 21.4 mg of Trehalose:Trileucine 85/15 w/w
15952677|NCT03243760|Drug|Placebo-2|Orange capsule containing a white to off-white powder, 21.4 mg of lactose. Placebo-2 to be used if unexpected safety signals are observed with the use of matching placebo.
15952678|NCT03243734|Device|trūFreeze® System spray cryotherapy|Subjects where trūFreeze® System spray cryotherapy is performed
15952679|NCT03243721|Diagnostic Test|7T MRI|A high field MRI that will take approximately one hour.
15952680|NCT03243721|Diagnostic Test|Neurocognitive testing|A series of tests to assess memory, verbal skills, and visuospatial skills.
15952681|NCT03243708|Behavioral|Risk calculator|Venous thromboembolism (VTE) risk calculator embedded in the admission order set with personalized recommendation for prophylaxis
15952682|NCT03243695|Other|Angled Abutment|virtual implants will be placed on a planning software allowing abutments to be placed at an angle to the implant. Teeth will be extracted at the surgery using periotome and implants will be placed using computer aided surgical guide. The angled abutment will be placed and a temporary crown material will be fabricated.
15952683|NCT03243695|Other|straight abutment|virtual implants will be placed on a planning software allowing abutments to be placed at straight to the implant. Teeth will be extracted at the surgery using periotome and implants will be placed using computer aided surgical guide. The straight abutment will be placed and a temporary crown material will be fabricated.
15952684|NCT03243682|Procedure|Bidirectional Shock Wave Lithotripsy|the alternating bidirectional (under and over table) approach during SWL for renal and upper lumbar ureteric stones
15952685|NCT03243682|Procedure|Standard Shock Wave Lithotripsy|the standard unidirectional approach during SWL for renal and upper lumbar ureteric stones
15952686|NCT03243669|Diagnostic Test|High-definition|High-definition colonoscopy
15952687|NCT03243669|Diagnostic Test|Virtual chromoendoscopy|Virtual chromoendoscopy
15952688|NCT03243669|Diagnostic Test|Standard|Standard colonoscopy
15952689|NCT03243656|Drug|Eltrombopag|An oral thrombopoietin receptor agonist
15952690|NCT03243643|Drug|HS-10241|HS-10241 is provided as white, film-coated,immediate release tablets containing HS-10241 at dosage strengths of 20mg/50mg/100 mg. Multiple tablets of HS-10241 will be administered daily to achieve targeted doses of HS-10241: 200 mg-1200 mg. Tablets will be orally administered with 240 ml water, once daily, 1 hour before/after a meal.
15952691|NCT03243643|Drug|Apatinib|Apatinib is provided as white, film-coated,immediate release tablets containing aptinib at dosage strengths of 250mg. Apatinib will be administered daily to achieve targeted doses of 500 mg. Tablets will be orally administered with 240 ml water, once daily, 1 hour before/after a meal.
15952692|NCT03243630|Drug|IV nicotine|Subjects in each arm will receive three infusions in a random order one hour apart. The infusions will be saline, 0.25mg/70kg and 0.5mg/70kg
15952693|NCT03243630|Drug|Menthol flavor|American e-liquids' menthol flavor used in e-cigarettes will be used as the placebo comparator
15952694|NCT03243630|Drug|green apple|green apple will be added to the menthol flavor
15952695|NCT03243630|Drug|green apple and menthol|menthol and green apple will be the active intervention
15952875|NCT03242096|Combination Product|Paclitaxel coated balloon|Predilatation of coronary ISR with POBA (balloon-to-stent ratio 1:1) followed by a paclitaxel coated balloon (SeQuent®Please balloon or SeQuent®Please NEO balloon with paclitaxel 3.0 μg/mm²) (paclitaxel 3.0 μg/mm²)
15952696|NCT03243617|Other|Placebo|"Subjects are instructed in the use of the spray bottle and asked to self-administer the Test Product as follows:
~LEFT side of the body where skin is affected: Five (5) pumps of Spray (BOTTLE LABELED: LEFT) must be applied twice-a-day to the entire area affected by KP once in the morning and once in the evening for 28 days.
~RIGHT side of the body where skin is affected: Five (5) pumps of Spray (BOTTLE LABELED: RIGHT) must be applied twice-a-day to the entire area affected by KP once in the morning and once in the evening for 28 days.
~Subjects may not wash their body with soap and water AFTER the applications"
15952697|NCT03243617|Other|AO+Mist|"Subjects are instructed in the use of the spray bottle and asked to self-administer the Test Product as follows:
~LEFT side of the body where skin is affected: Five (5) pumps of Spray (BOTTLE LABELED: LEFT) must be applied twice-a-day to the entire area affected by KP once in the morning and once in the evening for 28 days.
~RIGHT side of the body where skin is affected: Five (5) pumps of Spray (BOTTLE LABELED: RIGHT) must be applied twice-a-day to the entire area affected by KP once in the morning and once in the evening for 28 days.
~Subjects may not wash their body with soap and water AFTER the applications"
15952698|NCT03243604|Drug|L02 (sex hormones used in treatment of neoplastic diseases) and G03 (sex hormones)|Androgen-deprivation therapies including L02 (sex hormones used in treatment of neoplastic diseases), and G03 (sex hormones)
15952699|NCT03243591|Other|Livionex gel|Brushing area of mucositis with gel
15952700|NCT03243591|Other|Aquafresh gel|Aquafresh gel
15952701|NCT03243578|Other|None as this is an observational study|
15952702|NCT03243565|Biological|OM-85|OM-85 is an oral bacterial lysate of 21 different strains of 8 species and sub-species of the most common respiratory tract pathogens.
15952703|NCT03243565|Biological|Placebo|Pregelatinized starch (Starch 1500)+Mannitol+Magnesium stearate+Anhydrous propyl gallate+Sodium glutamate
15952704|NCT03243552|Drug|L-DOPA versus Placebo|Participants will be randomized in a blocked schedule to yield 1:1 L-DOPA: placebo assignment.
15952705|NCT03243552|Behavioral|Social Skills Training|ASD participants will be enrolled concurrently in a 16-week manualized, structured, group-based, social skills training program (PEERS).
15952706|NCT03243539|Procedure|Lung Protective Ventilation|Neuro lung protective ventilation for patients with acute brain injury is designed to target a normal partial pressure of arterial carbon dioxide and decrease initial tidal volumes toward a target 6 ml/kg predicted body weight PBW (range 6 to 8 ml/kg PBW)
15952707|NCT03243526|Other|fluid therapy|fluid resuscitation guided by CVP or PPV
15952708|NCT03243513|Other|Retrospective Chart Review|There is no intervention in this research. This research project is a retrospective chart review.
15952709|NCT03243500|Drug|Atracurium|5mg in 1 ml normal saline
15952710|NCT03243500|Drug|Lidocaine 2%|
15952711|NCT03243500|Drug|Bupivacaine 0.5%|
15952712|NCT03243500|Drug|hyaluronidase powder|1500 iu powder diluted in 2 vial lidocaine 20 ml resulting 37.5 IU/ml lidocaine and 93.7 / 2.5 ml lidocaine or 15.6 IU/ml of the 6 ml solution
15952713|NCT03243500|Procedure|per-caruncular peribulbar injection|The patient will lie in a supine position and the eyes are in the neutral position. The needle (25 Gauge (G), 25 mm) insertion point will be just medial to the caruncle, directly perpendicular to the face and parallel to the medial orbital wall to 15-20 mm depth. After negative aspiration the already chosen local anesthetic mixture will be injected slowly. During injection, the globe will be palpated with one finger and tension in the lids will be tested frequently, if the lids become tense or if the tension is felt to rise in the globe, the injection will be stopped. After injection, external compression with Honan balloon inflated to 20-30 mm Hg will be applied for 10 minutes and will be removed every 2 minutes to test akinesia and anesthesia
15952714|NCT03243487|Behavioral|structured adherence management program|Structured adherence management service (PAMS) program and a web-based information program designed for participants beginning positive airway pressure therapy
15952715|NCT03243487|Behavioral|Standard of care|Standard care provided at a VA Sleep Center for participants beginning positive airway pressure therapy
15952716|NCT03243461|Drug|Temozolomide + Valproic Acid|Valproic acid additionally to simultaneous radiochemotherapy with temozolomide
15952717|NCT03243435|Procedure|Native 1,5 Tesla breast MRI|
15952718|NCT03243422|Other|Successful aging education intervention|"The Successful Aging intervention will follow the protocol and materials developed for the 10 Keys™ to Healthy Aging program by the Center for Aging and Population Health Prevention Research Center at the University of Pittsburgh1. This interactive, dynamic program informs older adults about risk factors for diseases. Participants will meet individually with a health educator certified to administer the program every 2-3 weeks for a total of 4 visits over 8-10 weeks, and the session content will focus on a Key. Each session will also include a 5-10 minute active upper body extremity stretching program as used in the Lifestyle Interventions and Independence for Elders (LIFE) study. Participants will return for booster sessions semi-annually beginning at 6 months post-randomization."
15952719|NCT03243422|Other|Hearing intervention|The hearing intervention consists of fitting with hearing aids and other hearing assistive technologies plus four 1-hour comprehensive, individualized hearing rehabilitation sessions spaced over the 2-3 months post-randomization designed to provide all of the active components of the intervention. Hearing aids are instructed to be worn on a daily basis for study duration. Audiologic outcomes (e.g., hearing aid data logging, real ear measures, speech in noise, etc.) to verify the best-practices hearing intervention are gathered during study intervention visits and semi-annually beginning at 6 months post-randomization.
15952720|NCT03243396|Behavioral|Trauma-Focused Cognitive Behavioral Therapy|Eight small-group sessions, including eight children and one guardian for each child, will meet separately, with joint activities in the final three sessions. TF-CBT will be delivered via community health volunteers in the community setting, and via selected teachers in the school setting--with two lay counselors leading the child group, and one leading the guardian group. Most TF-CBT components (psychoeducation, parenting, relaxation, cognitive coping, grief specific skills) will be delivered in groups, but 2-3 individual sessions mid-group will be used for imaginal exposure (i.e., talking about/processing traumatic events).
15952721|NCT03243383|Other|DiaTOHC Program|"Patient-centered education 1a) Standardized diabetes discharge instructions and education 1b) Comprehensive discharge plan review
~Peri-discharge coordination of care
~A1c-based adjustment of diabetes therapy
~Post-discharge support"
15952876|NCT03242083|Other|quality of life questionnaire|quality of life questionnaire
15952722|NCT03243357|Procedure|TF Adaptive (First Apical Binding File)|"Procedure: TF Adaptive System NiTi (Nickel titanium) Endo File System (SybronEndo) The root canal instrumentation will be performed by the TF Adaptive features Adaptive Motion (Elements Motor).
~Procedure: Instrumentation based on protocol of First Apical Binding File The enlargement of the root canal will be performed with three files larger than the diameter of the previously established initial apical file."
15952723|NCT03243357|Procedure|TF Adaptive (Control)|"Procedure: TF Adaptive System NiTi (Nickel titanium)Endo File System The root canal instrumentation will be performed by the TF Adaptive features Adaptive Motion (Elements Motor).
~Procedure: Instrumentation based on manufacturer's protocol The enlargement of the root canal will be performed according to the manufacturer's directions."
15952724|NCT03243344|Device|Surgiflo|using device during the endonasal surgery.
15952725|NCT03243344|Device|Floseal|using device during the endonasal surgery.
15952726|NCT03243344|Device|Algosteril|using device during the endonasal surgery.
15952727|NCT03243331|Drug|Gedatolisib|Gedatolisb will be intravenously administered on Day 1, Day 8 and Day 15 of every 21 day cycle at a dose of 110 mg or 180mg depending on cohort assignment.
15952728|NCT03243331|Drug|PTK7-ADC|PTK7-ADC will be administered on Day 1 of every 21 day cycle at a dose of 1.4mg/kg or 2.8 mg/kg depending on cohort assignment.
15952729|NCT03243318|Diagnostic Test|MEPs induced by TMS|Using TMS induced MEPs over motor cortex of the affected side to predict motor recovery potentials
15952730|NCT03243305|Drug|AMPHORA|non-hormonal contraceptive vaginal gel
15952731|NCT03243292|Other|Bronchial Thermoplasty|patients had radio frequency ablation of the smooth muscle for asthma
15952732|NCT03243266|Diagnostic Test|CBC/Diff Reference Interval|Results will not be used to manage patients
15952733|NCT03243253|Other|all the data collection have done by CDC.|In this study there was no intervention, just simple data collection via CDC.
15952734|NCT03243240|Diagnostic Test|mutlidetector computed tomography|"Multidetector computed tomography angiography with 16- MSCT scanner, medical system bright speed. Our protocol will include non-enhanced scanning then perform a triphasic angiography that includes arterial, portal and venous phases to detect acute gastrointestinal bleeding.
~Images will be acquired with the following parameters slice thickness 5mm for the unenhanced phase and 1.25mm for the arterial phase and porto-venous phases"
15952735|NCT03243227|Other|Neurodynamic techniques|4 sessions of Neurodynamics treatment will be provided by and experienced physiotherapist. It will include manual therapy, median nerve gliding exercise, median nerve tension exercise. patients will continue the exercises as home exercise program during and after the treatment period.
15952736|NCT03243227|Other|Exercise therapy|AROM exercise stretching exercise strengthening exercise 4 sessions
15952737|NCT03243214|Device|TMS|Real or Sham TMS will be given to the PD-MCI patient
15952738|NCT03243214|Device|Sham-TMS|Real or Sham TMS will be given to the PD-MCI patient
15952739|NCT03243201|Drug|Colloidal silver nanoparticles|Contains 10ppm colloidal silver nanoparticles
15952740|NCT03243201|Other|Purified Water|Purified water will be given as placebo
15952741|NCT03243188|Other|Qualitative interview|Qualitative data will be obtained through semi-structured interviews with adults with cancer and palliative care needs. Patients will be invited to bring their carer to the interview. EG will conduct and transcribe up to 30 audio-recorded semi-structured interviews, which will be carried out at the patient's preferred location (either at home, over the phone, or in a pre-booked room at St Joseph's Hospice). EG will ask questions relating to sociodemographic data (recording this on the Personal Information Sheet) prior to starting the interview.
15952742|NCT03243175|Drug|Apixaban 5 MG|Apixaban 5mg x 2 during 24 months
15952743|NCT03243175|Device|left atrial appendage closure|left atrial appendage closure
15952744|NCT03243162|Behavioral|CBPT-ACLR|The CBPT-ACLR program focuses on improving sports function and return to sport. CBPT-ACLR sessions cover realistic expectations, relaxation strategies, problem-solving training, cognitive restructuring, and behavioral self-management (i.e., graded activity, goal setting, managing setbacks and symptom management plans). Each session builds upon the content of the previous session using an action plan and weekly homework is personally tailored based on patient goals. The program consists of one preoperative telephone session and six postoperative telephone sessions with a physical therapist. Each patient randomized into the CBPT-ACLR program will receive a manual to follow along with the study therapist.
15952745|NCT03243162|Other|Education|The education program focuses on postoperative ACLR recovery. Sessions address benefits of physical therapy, proper biomechanics during sports and other functional activity, importance of early exercise after surgery, and ways to promote healing. Education on stress reduction, sleep hygiene, energy management, communication with health providers, and preventing future injury are also provided. The Education program is matched to the CBPT-ACLR treatment in terms of session frequency, length and contact with the study therapist. Each patient randomized into the Education program will receive a manual to follow along with the study therapist.
15952746|NCT03243149|Device|fMRI - GE Medical System|"Recovery from PTSD symptoms has been modeled experimentally as fear extinction that depends on three interconnected brain regions that involve the amygdala where extinction memories are stored, the subcallosal/subgenual cortex within the medial PFC involved in consolidation of the extinction memory, and the hippocampus which mediates the context specificity of context specificity of extinction.
~The two MRI systems are used for human research by many faculty and research groups at Duke and UNC, Chapel Hill. The center has two research dedicated General Electric MR 750 scanners with a field strength of 3 Tesla. These systems use a combination of General Electric production pulse sequences and custom research pulse sequences that have been developed by Brain Imaging and Analysis Center faculty and other MR physicists. The scanners are used for imaging and spectroscopy."
15952747|NCT03243136|Other|Exposure of interest is food insecurity|Households were considered food insecure if any of the following conditions were met in the past 12 months: 1) a member of the household worried that there would not be enough food to eat because of a lack of money, 2) a member's food intake was reduced as a result of there not being enough food to eat, or 3) the desired variety or quality of foods was not eaten because of a lack of money. This exposure variable was operationalized as a binary variable with levels of food secure vs. food insecure.
15953065|NCT03240783|Other|Sham Injection and/or oral placebo|The sham Injection procedure is needle placement down to muscle at the designated spinal level and no injection of any fluid. The oral placebo is a gelatine capsule packed with filler.
15952748|NCT03243123|Device|Robotic passive mobilization|The intervention was performed using the Gloreha (Idrogenet, Italy) robotic system. The system consists of a soft exoskeleton similar to a glove. Passive hand joints mobilization is provided by a hydraulic system. Each patient underwent a session of 20 min passive mobilization of the paretic hand.
15952749|NCT03243110|Diagnostic Test|breathing test|Spirometry is a non-invasive means of measuring lung function: The participant is asked to take a deep breath and then exhale into the sensor as hard and as long as possible. Soft nose clips may be used to prevent air escaping through the nose. If the participant does not show a definitive diagnosis of asthma, a methacholine challenge test will be performed to elicit bronchoconstriction in participants. In methacholine challenge test, the participant breaths in standardized dose of nebulized methacholine again. Methacholine challenge test is widely accepted and standardized method for assisting the diagnosis of asthma and there will be no experimental altercation in the method methacholine challenge is performed.
15952750|NCT03243097|Device|Phase I - Standard Microphone Cros Input|Subject will be fit with the research processor plus CROS microphone and wear for a 4 week period
15952751|NCT03243097|Device|Phase II - Automatic directional microphone Cros Input|Automatic directional microphone technology will be activated in the research processor. Subjects will wear the CI+CROS configuration with directionality activated exclusively for 4-weeks.
15952752|NCT03243097|Device|Phase III - No Cros Input|Subjects will return the research processor and CROS device and wear their own processor for a 2-week period
15952753|NCT03243084|Device|XCSITE100 Stimulator Sham|The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session
15952754|NCT03243084|Device|XCSITE100 Stimulator tACS|Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied
15952755|NCT03243071|Behavioral|Tailored Website|Participants randomized to the intervention arm will have free access to a password protected interactive culturally and linguistically tailored website via a tablet device. No private identifiable data about you will be collected. Participants will receive a brief 10-minute tutorial by a trained research assistant on login procedures and use of the website.
15952756|NCT03243071|Behavioral|Standard Website|Participants randomized to the control condition will have free access to the NYU standard clinical trials website. Participants in the control condition will have access to the tailored website at the date of study completion (no later than 6 months' post-date of enrollment).
15952757|NCT03243058|Biological|ILT-101 (Aldesleukin; IL-2)|Administration of Low-Dose Interleukin-2 (ILT-101) for two years
15952758|NCT03243058|Other|Treatment-Placebo Arm|Administration of Low-Dose Interleukin-2 (ILT-101) for one year, and then placebo for the second year.
15952759|NCT03243058|Other|Placebo Arm|Participants in this group will receive a placebo injection for two years.
15952760|NCT03243045|Procedure|Renal sympathetic denervation|Transcutaneous renal sympathetic denervation
15952761|NCT03243032|Drug|Ibuprofen 600 mg|Ibuprofen 600mg given 30 minutes prior to beginning of surgery
15952762|NCT03243032|Drug|Local anesthetic Group 1|0.5% bupivacaine with 1:200,000 epinephrine as the local anesthetic for Group 1 Experimental.
15952763|NCT03243032|Drug|Placebo oral capsule|Placebo (Microcrystalline Cellulose NF (Avicel PH 105) - compounded at the University of Iowa College of Dentistry Pharmacy) given 30 minutes prior to beginning of surgery
15952764|NCT03243032|Drug|Local anesthetic Control|2% lidocaine with 1:100,000 epinephrine as the local anesthetic for Group 2 - Control
15952765|NCT03243019|Drug|rapamycin|oral administration
15952766|NCT03243019|Device|MRI|cervicofacial MRI
15952767|NCT03243019|Biological|Rapamycin dosage|Biological dosage of Rapamycin level
15952768|NCT03243006|Drug|Paracetamol|2 tablets of 500mg of paracetamol
15952769|NCT03243006|Drug|Tramadol/Paracetamol combination|2 tablets of tramadol/paracetamol combination (32.5mg/325mg)
15952770|NCT03243006|Drug|Placebo Oral Tablet|2 tablets of placebo
15952771|NCT03242993|Drug|[18F]-AzaFol|[18F]-AzaFol is a radiotracer produced at ETH Hönggerberg in a radiopharmaceutical GMP facility. The drug product is provided as sterile solution for intravenous injection in a glass vial containing 6 mL of formulated product, the maximal applicable dose being 600 MBq.
15952772|NCT03242993|Drug|folarell|"For the purpose of this study only 1 mg folic acid (corresponding to 0.2 mL Folarell®) will be injected 5 min prior to [18F]-AzaFol. Due to this low dose of a single injection of folic acid it is unlikely that adverse events would occur.
~Folarell® is a folic acid preparation for intravenous or intramuscular injection"
15952773|NCT03242980|Behavioral|Structured adherence counseling|"Patients will undergo one standardized enhanced adherence counselling session. Counselling guidelines and a brochure were specifically developed to guide the adherence counselling for individuals with unsuppressed VL. All nurses at the health centres will be trained on the counselling prior to the cross-over to the intervention. The brochure was developed by culturally adapted by social scientists and contains only 3 key messages. The brochure will be given to the patient to take home.
~Four weeks after the adherence counselling session, a SMS will be sent to the patient reminding them to take their ART. The content of the text message will be anonymous to protect disclosure and discussed/agreed upon with the patient during the adherence counselling."
15952774|NCT03242967|Drug|Vadadustat|Oral tablet
15952775|NCT03242967|Drug|Darbepoetin alfa|subcutaneous or intravenous
15952776|NCT03242954|Other|Autonomous minor consent|Consent requirement where the participant is not required to get anyone's permission to participate in the trial.
15952777|NCT03242954|Other|Adult permission required|Consent requirement where the participant is required to obtain an adult's permission to participate in the trial.
15952778|NCT03242954|Other|Parental permission required|Consent requirement where the participant is required to obtain their parent's permission to participate in the trial.
15952810|NCT03242681|Procedure|Endoscopy Assisted Probing procedure|The patency of the system will be tested by irrigation with 1 ml normal saline. A cannula was introduced via the upper or lower canaliculus as far as the lacrimal sac and fluid injected through the system from a 5 ml syringe. Nasal endoscopy and irrigation will be performed simultaneously and free flow of fluid from the lacrimal sac to the nose will confirm anatomical patency of the system
15952779|NCT03242941|Procedure|Pulmonary vein ablation|After pulmonary vein isolation, during the routine waiting time of half an hour to confirm efficacy of the ablation, the septal catheter, already in place in right atrium, will be positioned on the interatrial septum. If the patient will not be in sinus rhythm, he/she will be externally cardioverted in order to determine pacing thresholds and impedances on all septal catheter electrodes. Next, atrial fibrillation will be induced by rapid atrial pacing.AF cycle length will be determined in the left atrial appendage, during 1 minute of atrial fibrillation using ablation catheter electrodes. Subsequently, a pacing scheme will be applied and capture on decapolar recording catheters, already in place for the standard ablation procedure will be assessed as well as AF termination.
15952780|NCT03242928|Drug|AFQ056|50 mg and 100 mg tablets taken orally
15952781|NCT03242928|Drug|Placebo|Matching placebo tablets taken orally BID
15952782|NCT03242915|Drug|Pembrolizumab|200mg IV every 3 weeks
15952783|NCT03242915|Drug|Carboplatin|AUC 5 IV every 3 weeks
15952784|NCT03242915|Drug|Pemetrexed|500 mg/m^2 IV every 3 weeks
15952785|NCT03242902|Device|Light therapy intensity 1|Exposure to white light (10.000 lux) in the morning
15952786|NCT03242902|Device|Light therapy intensity 2|Exposure to white light (10-20 lux) in the morning
15952787|NCT03242889|Drug|DARA SC|Participants will receive 1800 mg daratumumab with 30,000 U (2000 U/mL) rHuPH20 SC injection once weekly for the first 8 weeks in Cycles 1 and 2 and every 2 weeks in Cycles 3 to 6 for 16 weeks and then every 4 weeks in subsequent cycles until disease progression, unacceptable toxicity, or any other reason for discontinuation.
15952788|NCT03242876|Other|Control|Control will be 109 g white bread to be consumed together with 200 mL water
15952789|NCT03242876|Other|Test|Test will be 109 g white bread to be consumed together with 3.819 g citric acid and 119 mg malic acid dissolved in 200 mL water adjusted to pH 3.2.
15952790|NCT03242863|Other|Food proportionality|Proportions of high and low energy dense foods manipulated
15952791|NCT03242850|Behavioral|Intervention Group|This group will view a video on shared reading upon enrollment, receive standard guidance on shared reading, and receive a series of text messages for a period of 6 months.
15952792|NCT03242837|Behavioral|Army Resilience Training|The Army Resilience Training consists four training sessions of 90 minutes each. Participants learn to reflect their stress management (including thinking, emotions, behavioral consequences; coping strategies) and build resilience using specific strategies.
15952793|NCT03242837|Other|Diversity Management Training|Diversity Management Training consists four training sessions of 90 minutes each. Participants learn about diversity and social awareness reflecting different situations and settings.
15952794|NCT03242824|Drug|Fluorine F 18 Fluorodopa|Contrast used in PET
15952795|NCT03242824|Radiation|Intensity-Modulated Radiation Therapy|Radiation of different intensities are aimed at the tumor from many angles. This type of radiation therapy reduces the damage to healthy tissue near the tumor
15952796|NCT03242824|Procedure|Positron Emission Tomography|imaging test
15952797|NCT03242811|Diagnostic Test|MRI scan of knee, ankle and wrist|"At the day of the intervention, the subject is informed about the study by a nurse and provides written informed consent.
~Girls must leave urine tests to rule out pregnancy. The questionnaire for the study is answered by the subject and weight and length are measured. The subject is asked to self-assess his/her puberty.
~After detailed information on how a magnetic camera examination is carried out, an examination of five selected growth zones (knee joint, ankle joint including heel leg and wrist) is performed using 1.5 Tesla magnetic camera with dedicated cartilage sequence."
15952798|NCT03242785|Other|Self-monitoring/Self-titration|"The intervention of the ADAMPA trial is not pharmacological but an intervention that modifies usual clinical practice. The intervention of self-monitoring and self-titration of the medication is composed of 3 elements:
~Education of the patient: information and training on hypertension, its risks, management, the benefits of an adequate control and the generic measures for an optimal control.
~Training for self-monitoring: Patients will be trained to perform the self-measurement of blood pressure correctly (and recording their values in the sheet enabled for this purpose)
~Training for self-titration: patients will be instructed on the target BP numbers, individualized for each patient, on the mode of action against specific figures, including self-adjustment of drug treatment."
15952799|NCT03242772|Drug|Amphetamine|Study drug will be administered in the morning. Treatment will be initiated at 1 tablet = 3.1 mg or 0 mg of mixed amphetamine. Doses will be flexibly titrated upward and may be decreased or stopped at any time.
15952800|NCT03242772|Behavioral|ESDM informed parent coaching|All participants will receive 8 weekly parent child therapy sessions will be delivered by a therapist trained in parent coaching and ESDM principles and strategies and utilizing a therapy manual,(includes coaching for behavior management and handouts).
15952801|NCT03242772|Drug|Placebo Oral Tablet|Matched placebo tablets will be administered in the morning and provided for 11 weeks . The tablets will be titrated in the same way as the active drug and may be stopped at any time.
15952802|NCT03242759|Drug|nintedanib|Drug
15952803|NCT03242759|Drug|pirfenidone|Drug
15952804|NCT03242733|Other|Ultrasound assessment of gastric contents|Ultrasound assessment of gastric contents is performed in fasted elderly patients for hip fracture surgery.
15952805|NCT03242720|Procedure|Cardiac Ablation for Atrial Fibrillation|Ablation of arrhythmia focus in the heart for atrial fibrillation
15952806|NCT03242707|Biological|Autologous adipose tissue injection|"20ml to 40ml of subcutaneous adipose tissue will be aspirated from the abdomen. Adipose tissue will be processed using the Lipogems device, a closed-loop processing device used in medical procedures involving the harvesting, concentrating and transferring of autologous adipose tissue.
~The resulting fat product will be delivered locally via ultrasound-guided, intra-articular injection."
15952807|NCT03242707|Drug|Hyaluronic Acid|Synvisc-One® is a high molecular weight sodium hyaluronate.
15952808|NCT03242694|Diagnostic Test|LA pressure, voltage map, strain, scar-map, blood sampling|invasive LA pressure monitoring, LA voltage map creation, LA strain evaluation by transthoracal echocardiography, LA scar-mapping by cardiac MRI, defining biomarkers from blood samples during atrial fibrillation and after pulmonary vein isolation in sinus rhythm
15952809|NCT03242694|Procedure|pulmonary vein isolation|pulmonary vein isolation without creating additional ablation lesions
15953066|NCT03240770|Device|VPro5 device|Use of the VPro5 device for 5 minutes a day
15954049|NCT03233230|Drug|Placebo|Participants received placebo matched to M2951 orally for 12 weeks.
15952811|NCT03242668|Procedure|VATS|General anesthesia was induced with 2.0 mg/kg of propofol, 2.0 mg/kg of fentanyl, and 1.0 mg kg/1 of rocuronium and maintained with continuous infusion 6-12mg/kg/h of propofol,injected 2.0 mg/kg of fentanyl and 0.15 mg/ kg of rocuronium every 30 minutes . All patients were intubated with a double-lumen endobronchial tube for one-lung ventilation.The VATS (Video-Assisted Thoracic Surgery) was performed.
15952812|NCT03242668|Procedure|PVB using PVC|At the end of the surgery, the upper edge of the spinous process of the thoracic vertebral body was recognized. With an epidural needle (Tuohy 22 G; Braun, Melsungen, Germany), the injection point was punctured 2 cm lateral to the midline. The paravertebral space was entered by advancing the Tuohy needle over the superior border of the transverse process. Once in the right place, the PVC was placed through the needle, checking the tip remained placed when removing the needle. The advance of the needle and the entering of the catheter into the paravertebral space were verified all the time by the surgeon using the camera. The PVC (Paravertebral Catheter ) was inserted at this point preversed at this area.
15952813|NCT03242668|Drug|PCA|PVC was inserted.Initiated dose of 0.3ml/kg of Bupivacaine Hydrochloride 1.25mg/ml and Fentanyl Citrate 2 micrograms/ml was administered then continued PCA (Perfusor space pump,Germany)with background rate 3ml/h, bolus dose 2ml was infused through PVC.
15952814|NCT03242655|Behavioral|HCV GET-Up (Group Evaluation and Treatment Uptake)|Groups will meet for 4 weekly 1-hour sessions facilitated by the PI and focused on providing education, motivation, and behavior change skills, along with an HCV medical evaluation. Patients will then be offered HCV treatment by individual provider after 4-week group evaluation and education intervention.
15952817|NCT03242629|Drug|oral chloral hydrate|Chloral hydrate syrup was available in a concentration of 100 mg×ml-1.The children assigned to receive 0.8 ml×kg-1 of chloral hydrate (80 mg×kg-1) by oral.
15952818|NCT03242629|Drug|enema chloral hydrate|Chloral hydrate syrup was available in a concentration of 100 mg×ml-1 at our hospital.The children assigned to receive 0.8 ml×kg-1 of chloral hydrate (80 mg×kg-1) by enema.
15952819|NCT03242616|Drug|Pemetrexed + Vinorelbine|"Vinorelbine (25 mg/m2, day 1 & 8)
~Pemetrexed (500 mg/m2, day 1)"
15952820|NCT03242616|Drug|Vinorelbine|Vinorelbine (25 mg/m2, day 1 & 8)
15952821|NCT03242603|Biological|Anti-GD2 in combination with NK cells|Haploidentical donor NK cells will be expanded over 10 days and infused in combination with anti-GD2. Anti-GD2 will be given as daily infusion for 5 days ; D-1, 0,+1, +2 and +3. NK cells will be infused at single dose on day 0. The patient will receive cyclophosphamide 60mg/kg on day -3 and day -2 prior to the NK cell infusion. IL- 2 will be given subcutaneously for 6 doses every alternate day starting on day -1, for NK cell survival.
15952822|NCT03242590|Drug|LPCN 1021|Oral testosterone undecanoate
15952823|NCT03242564|Device|Vevazz LED|Vevazz LED red light therapy is a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist and thighs.
15952824|NCT03242551|Drug|Chemotherapy|"AC followed by T Chemotherapy with or without trastuzumab, i.e. Epirubicin 100mg/m2 and cyclophosphamine 600mg/m2 for four cycles followed by paclitaxol 175mg/m2 for four cycles with (for patients with positive HER-2) or without Trastuzumab (loading dose of 6 mg/kg followed by 4 mg/kg every 2 weeks for four cycles), each cycle is 14 days."
15952825|NCT03242538|Behavioral|Pelvic Exercise|Hip extension and external hip rotation exercises are completed prior to daily external beam radiation treatment.
15952826|NCT03242525|Diagnostic Test|POCT and central laboratory blood analysis|In every participant blood analysis will be performed by POCT and central laboratory investigating the time advantage.
15952827|NCT03242512|Biological|TK006|Subcutaneous injection
15952828|NCT03242499|Drug|Lovastatin|Lovastatin 80mg or placebo use for 48 weeks.
15952829|NCT03242499|Drug|Placebo|placebo for 48 weeks
15952830|NCT03242486|Device|toric intraocular lens|
15952831|NCT03242473|Other|Fluid Management|The patient will remain NPO for at least the first 24 hours. The following studies will be obtained at the time of admission if not previously obtained in the ED: CMP, GGT, Amylase, Lipase, Triglycerides, CBC, and CRP, along with an abdominal ultrasound. CBC, CRP, BMP, amylase and lipase levels will be obtained at 24 and 48 hours (+/- 2 hours). SIRS status will be evaluated with vital sign checks every 4 hours and the leukocyte counts every 24 hours.
15952832|NCT03242460|Drug|Pomalidomide 4 MG|Pomalidomide 4mg Days 1-21
15952833|NCT03242460|Drug|Dexamethasone 20mg|Dexamethasone 20mg Days 1, 8, 15, 22
15952834|NCT03242460|Drug|Cyclophosphamide 400mg|Cyclophosphamide 400mg Days 1, 8, 15
15952835|NCT03242447|Behavioral|e-Practice Self-Regulation|e-PS-R utilizes 'blended learning', the combination of online and face-to-face instruction, and incorporates online videos and interactive elements that have been shown to be effective with high-risk youth. e-PS-R consists of eight 30-minute e-learning sessions for youth participants and four 30-45 minute one-on-one in-person meetings between youth and a trained facilitator.
15952836|NCT03242447|Behavioral|Video Health Group|The video for the control condition will be The Toxic Life Cycle of a Cigarette, a 17-minute video that details the negative effects that cigarettes have on the environment and on people who manufacture and use cigarettes.
15952837|NCT03242434|Other|Lactulose and Mannitol solution|Participants will receive 100 milliliter (mL) oral solution of Lactulose [5 grams (g)]/ Mannitol (2g), a non-investigational medicinal product, by oral route to measure intestinal permeability.
15952838|NCT03242434|Other|Sucralose|Participants will receive 3 capsules of Sucralose (2g), a non-investigational medicinal product, by oral route to measure intestinal permeability.
15952839|NCT03242408|Drug|LPCN 1021|Oral testosterone undecanoate
15952840|NCT03242382|Drug|Palbociclib|Treatment will continue until disease progression, development of unacceptable toxicity, non-compliance, withdrawal of consent by the patient or investigator decision
15952841|NCT03242369|Procedure|colonoscopy|100 patients undergoing colonoscopy will be prepared with split dose (2+2l) PEG. 2 liters will be drunk during 2 hours in the evening the day before colonoscopy, the second 2l during 2 hours in the day of colonoscopy finishing the dose 4- 6 hours before colonoscopy.
15953067|NCT03240770|Other|Deviation from Standard Tray Wear Time (14 Days)|Patients reduced Tray Wear Time Interval (14 Days)
15952842|NCT03242369|Procedure|colonoscopy|100 patients undergoing colonoscopy will by prepared with split dose of SS. The first bottle of SS with water (total volume 0,5l) will be drunk in the evening the day before colonoscopy during 1 hour, than another 1liter of clear fluid will be drunk. The same procedure will be repeated with the second bottle of SS finishing at least 3 hours before colonoscop
15952843|NCT03242369|Procedure|colonoscopy|100 patients undergoing colonoscopy will be prepared with split dose of PEG (1+1L) with ascorbic acid. The first 1l of solution will be drunk in the evening the day before colonoscopy, the second 1l of solution in the day of colonoscopy finishing 4-6 hours before the examination. Another 1l of clear fluid should be drunk during the cleansing process.
15952844|NCT03242369|Procedure|colonoscopy|100 patients undergoing colonoscopy will be prepared with split dose (150ml +150ml) of solution of magnesium acid and sodium picosulfate. The first dose will be drunk in the evening the day before colonoscopy, then at least 1l of another clear fluid will be drunk within a few hours, the second dose will be drunk in the day of examination finishing 4-6hours before colonoscopy and then another at least 750ml clear fluid.
15952845|NCT03242356|Other|Questionnaire to assess of the application of the current French guidelines as to fasting during labor.|"Questionnaire focuses on :
~oral intake of clear fluid during the labor
~oral intake of solid meal during the labor
~fasting duration for solid and liquids
~instruction received as to fasting during labor, nature of these instructions, and who given the instruction (midwife, nurse anesthetist, …)
~discomfort related to thirst during labor
~discomfort related to hunger during labor
~We will also record several medical data as to the course of pregnancy and delivery, analgesia technique, history and characteristics of the parturient."
15952846|NCT03242343|Device|VasQ|An external support device for AV fistula
15952847|NCT03242330|Device|Subperiosteal implant|Subperiosteal implants are placed and fitted 'onto' the jaw bone just right below the mucoperiosteum; where the post of the metal frame is in a protruding position through the mucosa holding the prosthesis that will be later fitted.
15952848|NCT03242317|Drug|Mitomycin C|The surgical procedure includes a low dose, short duration MMC treatment on the exposed stromal bed of the non-dominant eye, before the unilateral implantation of the corneal inlay. This treatment is at a concentration of 0.2 mg/mL (0.02%) applied for 10 to 30 seconds on the stromal bed as well as the stromal side of the corneal flap or pocket.
15952849|NCT03242317|Device|Raindrop Near Vision Inlay|The surgical procedure includes the unilateral implantation of the Raindrop Near Vision Inlay in the non-dominant eye for the improvement of uncorrected near vision.
15952850|NCT03242304|Other|Behavioral tests|We observed relationship between plasma levels of cortisol and neurological, cognitive, functional and emotional outcomes in patients with acute ischemic stroke.
15952851|NCT03242291|Other|Conventional resin-based flowable composite|assessment of marginal integrity of Conventional resin-based flowable composite
15952852|NCT03242291|Other|Hydroxyapatite Nanofiber reinforced flowable composite|assessment of marginal integrity of Hydroxyapatite Nanofiber reinforced flowable composite
15952853|NCT03242278|Drug|Rivaroxaban (Xarelto, BAY59-7939)|As prescribed by treating physicians
15952854|NCT03242265|Diagnostic Test|IVDD for NK cell activity in whole blood|Two samples of one mL of blood (for baseline IFN-gamma activity and for NK cell activity) and blood samples collected for C-Reactive Protein and White Blood Cell Count, taken up to 8 weeks prior to biopsy and before treatment with antibiotics.
15952855|NCT03242252|Drug|Placebo|"Placebo tablet (identical to sotagliflozin 200 mg in appearance), orally once daily.
~Route of administration: Oral"
15952856|NCT03242252|Drug|Sotagliflozin|"Sotagliflozin 200 mg, tablet, orally once daily.
~Route of administration: Oral"
15952857|NCT03242239|Biological|ALT02|
15952858|NCT03242239|Biological|EU-licensed Herceptin|
15952859|NCT03242239|Biological|US-licensed Herceptin|
15952860|NCT03242226|Device|two spectacles|single-vision spectacles for distant vision, and +3.00ADD spectacle for near vision
15952861|NCT03242226|Device|single vision spectacles|Wear single vision spectacle only
15952862|NCT03242213|Behavioral|Mobile App|The intervention in this study is a mobile health app, which provides patients with a way to track emotional wellbeing and depression symptoms, set up medication reminders, track adherence to medications, record side effects experienced, and take surveys/tests to assess cognitive symptoms and depression.
15952863|NCT03242200|Other|Mobile Health App|Mobile Health is a multi-featured app designed to enable participants to self-record and track their health and wellness. Participations will set up a profile and complete questionnaires. The app also records the amount of time and features of programs accessed.
15952864|NCT03242187|Procedure|Trans-anal total mesorectal excision(TaTME)|Trans-anal total mesorectal excision(TaTME) will be offered to patients in this group (assisted by minilaparoscopy to control the IMA and splenic flexure mobilisation)
15952865|NCT03242187|Procedure|Lap. TME|Laparoscopic total mesorectal excision(Lap.TME) starting by IMA ligation then splenic flexure mobilisation and pelvic dissection
15952866|NCT03242174|Other|Health Behavior Questionnaire Packet|Any pregnant woman offered the questionnaire at her prenatal appointment in the third trimester can complete
15952867|NCT03242161|Diagnostic Test|LabPatch-alcohol|a wearable, non-invasive biosensor Band-Aid like patch that is designed to detect real-time changes in interstitial alcohol concentrations in human subjects after they have consumed alcohol
15952868|NCT03242148|Device|Toffee Nasal Pillows Mask|Participants will be placed on this intervention for a total 14 ± 5 days from Visit 2. Participants will be using the Toffee nasal pillows mask during this treatment arm.
15952869|NCT03242122|Other|CHO Control 1 and 2 Glucose|mixed in 237 ml/8 fl oz of a flavored non-caloric beverage; 1 time consumption
15952870|NCT03242122|Other|CHO Experimental 1 Slowly Digested|mixed in 237 ml/8 fl oz of a flavored non-caloric beverage; 1 time consumption
15952871|NCT03242122|Other|CHO Experimental 2 Digestion Resistant|mixed in 237 ml/8 fl oz of a flavored non-caloric beverage; 1 time consumption
15952872|NCT03242122|Other|CHO Experimental 3 Low Sugar|mixed in 237 ml/8 fl oz of a flavored non-caloric beverage; 1 time consumption
15952873|NCT03242122|Other|CHO Experimental 4 Maltodextrin|mixed in 237 ml/8 fl oz of a flavored non-caloric beverage; 1 time consumption
15952874|NCT03242096|Combination Product|Sirolimus coated balloon|Predilatation of coronary ISR with POBA (balloon-to-stent ratio 1:1) followed by a sirolimus coated balloon (SeQuent®SCB balloon with sirolimus 4.0 μg/mm²)
15952877|NCT03242070|Other|Theory-based PP eLearning Program(T-PeP)|"Theory-based PP eLearning Program (T-PeP) was developed based on self-efficacy theory42-44 to improve older adults' use of PPs for managing their care and includes learning modules, discussion boards, and other resources. Considering variations in the types and usability of PPs used by patients nationwide, T-PeP was developed as a vendor-agnostic (not tied to a specific vendor) program."
15952878|NCT03242057|Other|NAVA|Infant will be extubated to NAVA, settings based per protocol
15952879|NCT03242057|Other|NIPPV|Infant will be extubated to NIPPV, settings detailed in protocol
15952880|NCT03242044|Procedure|Congenital diaphragmatic hernia resuscitation with an intact umbilical cord|10 infants with left or right sided congenital diaphragmatic hernia will be intubated and ventilation initiated while still attached to the placental circulation through the umbilical cord. In addition, at the same time, a nasogastric tube will be placed in the stomach to drain entrained air and secretions. After 5 minutes of resuscitation with the umbilical cord intact, the umbilical cord will be cut, infants separated from the placenta and resuscitation performed per routine neonatal resuscitation protocols. Feasibility, the optimal approach and maternal and infant tolerance to the procedure will be assessed as part of the study.
15952881|NCT03242031|Procedure|monospot panretinal photocoagulation|panretinal photocoagulation with monospot laser
15952882|NCT03242031|Procedure|multispot panretinal photocoagulation|panretinal photocoagulation with multispot laser
15952883|NCT03242018|Drug|Placebo|Placebo tablet (identical to sotagliflozin 200 mg in appearance) orally, once daily.
15952884|NCT03242018|Drug|Sotagliflozin|Sotagliflozin 200 mg, tablet, orally, once daily.
15952885|NCT03242005|Device|MiniMed® Pro-set®|Utilization of the MiniMed® Pro-set® to administer the subject's current insulin therapy.
15952886|NCT03242005|Device|MiniMed® Quick-set®|Utilization of the MiniMed® Quick-set® to administer the subject's current insulin therapy.
15952887|NCT03241992|Behavioral|MyChart Disease Specific|Subjects receive targeted IBD information and reminders as well as mood questionnaires.
15952888|NCT03241953|Procedure|Periodontal surgery|A total of forty dental implants were debrided with either ultrasonic instruments (test, n=20) or plastic scaler (control, n=20). Gingival recession depth (RD), keratinized tissue width (KTW), probing depth (PD), Gingival Index (GI) were evaluated at baseline and after 6 months. CBCT radiographs were used to evaluate peri-implant bone loss. Supportive and nonsurgical periodontal therapies were firstly consulted to reduce the inflammation, occurring due to the surgical treatments of the defects. The formation of bacterial biofilm on implant surfaces was removed by ultrasonic scaler and air polishing
15952889|NCT03241940|Biological|Chimeric Antigen Receptor T-Cell Therapy|Given CD19/CD22-CAR T cells IV
15952890|NCT03241940|Drug|Cyclophosphamide|Given IV
15952891|NCT03241940|Drug|Fludarabine Phosphate|Given IV
15952892|NCT03241940|Other|Laboratory Biomarker Analysis|Correlative studies
15952893|NCT03241940|Other|Questionnaire Administration|Ancillary studies
15952894|NCT03241927|Biological|Pembrolizumab|Day 1 of each 3 week cycle
15952895|NCT03241914|Drug|Megestrol Acetate|At a dosage of 160 mg/day
15952896|NCT03241914|Device|Levonorgestrel-releasing Intrauterine System(LNG-IUS)|levonorgestrel 52mg. It is a hormone-releasing T-shaped intrauterine system.
15952897|NCT03241901|Drug|Artemether-Lumefantrine Tab 20-120mg|Artemether-Lumefantrine Tablet 20-120mg
15952898|NCT03241901|Drug|Primaquine Phosphate 0.25 mg/kg|Primaquine Phosphate 0.25 mg/kg
15952899|NCT03241901|Other|Placebo|Aqueous solution prepared to mimic the taste of the intervention drug.
15952900|NCT03241888|Drug|Megestrol Acetate|At a dosage of 160 mg/day
15952901|NCT03241888|Device|Levonorgestrel-releasing Intrauterine System(LNG-IUS)|Active ingredient: levonorgestrel 52mg. It is a hormone-releasing T-shaped intrauterine system.
15952902|NCT03241875|Drug|Pregabalin 75mg|In this group, premedication is performed with 2 capsules of pregabalin 2 hours before anesthetic induction.
15952903|NCT03241875|Drug|Gabapentin 300mg|In this group, premedication is performed with 2 capsules of gabapentin 2 hours before anesthetic induction.
15952904|NCT03241875|Drug|Placebo oral capsule|In this group, no premedication is performed, but patients receive 2 capsules of placebo 2 hours before anesthetic induction.
15952905|NCT03241862|Device|Restylane® Silk|Restylane® Silk (Galderma Laboratories, L.P.) is a hyaluronic acid injectable filler, which is approved by the FDA for submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids.
15952906|NCT03241849|Procedure|Modified surgical technique for placenta accreta|suturing of the myometrium splitted by the placenta in cases presented by placenta accreta
15952907|NCT03241836|Diagnostic Test|trans-perineal ultrasonography|accuracy of trans perineal ultrasonography in identification of female pelvic floor dysfunction
15952908|NCT03241823|Diagnostic Test|Abdominal ultrasound .|Abdominal ultrasound for each patient before and after treatment.
15952909|NCT03241823|Diagnostic Test|Model for End-Stage Liver Disease|Model for End-Stage Liver Disease before and after treatment.
15952910|NCT03241823|Diagnostic Test|Fibro Scan.|Liver stiffness by Fibro scan before and after treatment.
15952911|NCT03241823|Diagnostic Test|Child-Turcotte-Pugh score.|Child-Turcotte-Pugh score before and after treatment
15952912|NCT03241810|Drug|Seribantumab|Seribantumab is a human monoclonal antibody that inhibits ErbB3 signalling
15952913|NCT03241810|Drug|Fulvestrant|Fulvestrant is an estrogen receptor antagonist with no agonist effects
15952914|NCT03241810|Drug|Placebo|Placebo
15952915|NCT03241797|Procedure|EUS-FNA|Once the lesion was evaluated by EUS, the echoendoscopist would select the shortest pathway, while avoiding blood vessels, to reach the lesion. Under real-time visualization, slow-pull technique and suction technique were used to punctured each lesions. The specimens were expelled onto glass slides, and then prepared for histological and cytological examinations.
15952916|NCT03241784|Biological|Autologous T-regulatory lymphocytes|intravenous administration of Autologous T-regulatory lymphocytes at a dose of 1x10 to the sixth /kg.
15952917|NCT03241784|Biological|Interleukin-2|Subcutaneous Interleukin-2 at a dose of 2x10 to the fifth IU/m2, three times a week.
15953128|NCT03240250|Procedure|VATS three-portal lobectomy and lymphoadenectomy|VATS three-portal lobectomy and lymphoadenectomy, Copenhagen approach
15953129|NCT03240237|Device|Optimizer SMART|Cardiac Contractility Modulation
15952918|NCT03241771|Behavioral|Naloxone Navigator 1.0|Patients on chronic opioid therapy will be outreached via email, mail and phone. Within 1 month of enrollment into the trial, intervention participants will receive a link to the web-based resource to view. This is designed to provide overdose education, increase opioid risk awareness, and encourage patients to obtain naloxone.
15952919|NCT03241758|Diagnostic Test|Doppler ultrasound|Basal Doppler ultrasound and Doppler ultrasound one year after radical prostatectomy
15952920|NCT03241745|Drug|Nivolumab|Nivolumab 480 mg IV once every 4 weeks
15952921|NCT03241732|Other|Anti-inflammatory Diet|Integrative diet that reduces saturated fats and carbohydrates and emphasizes proteins and omega-3 fats that help reduce inflammation and oxidative damage.
15952922|NCT03241732|Dietary Supplement|N-acetyl Cysteine|Intravenous and Oral n-acetyl cysteine
15952923|NCT03241719|Drug|IL-2|Subjects will receive vascularized composite allotransplantation (e.g. facial, hand and/or abdominal wall transplants) under conventional immune suppression. No sooner than 3 months after VCA, subjects will receive a protocol of daily recombinant IL-2 at low doses for 8 weeks.
15952924|NCT03241706|Drug|Fructose|IV fructose (1.3 mg/kg/min)
15952925|NCT03241706|Drug|Saline|Saline given as a comparison to fructose.
15952926|NCT03241706|Drug|Somatostatin|IV infusion of somatostatin (60 ng/kg/min)
15952927|NCT03241706|Drug|Insulin|IV infusion of insulin between 20-60 mU/m2/min.
15952928|NCT03241706|Drug|Glucagon|IV glucagon (0.65 ng/kg/min).
15952929|NCT03241706|Drug|Dextrose solution|IV dextrose to clamp the plasma glucose at the desired level.
15952930|NCT03241706|Drug|High Fructose|IV-fructose (6.5 mg/kg/min)
15952931|NCT03241693|Other|blended-learning in ethics|"Experimental group followed clinical practices in hospital centers during 8 months.
~In addition, an online specific syllabus about Professional Ethics was developed. It consisted of 6 themes and included topics as moral values, ethics and moral, bioethics and professional ethics, ecc. Six online related activities were created: to solve situations related to real clinical practices. Six face to face group sessions based on cooperative learning were planned in order to discuss ethical issues detected among clinical practices during 4 months. Students were divided in small groups, 4-5 participants each, and active participation techniques were used."
15952932|NCT03241693|Other|control group|"Control group followed clinical practices in hospital centers during 8 months as usual.
~In the control group, case study method was also used, thus students in control group had to create and perform a public exposition of a real clinical case about professional ethics. Cases had to be related to clinical practices in order to recognize ethical situations in the work environment. Neither online learning nor online activities were carried out."
15952933|NCT03241680|Diagnostic Test|Search of anal citology alterations|"All patients with a pathological diagnosis of CIN II and III, and in the general gynecological surgery outpatient clinic, will be selected at the outpatient clinic of Oncology Gynecology of the HCSL for a period of six months.
~Patients who meet the eligibility criteria will be clarified about the study, and only those who agree to participate will be included, by signing the informed consent form (TCLE)."
15952934|NCT03241667|Device|HemoCartridge|Our goal is to apply MEMS (microelectromechanical systems) and nanotechnology to miniaturize the bioartificial kidney (BAK) into an implantable, self-monitoring, and self-regulating renal surrogate. The implantable BAK (iBAK) is a biocompatible cartridge containing stacks of hemofilter membranes (HemoCartridge) and renal tubule cell bioreactors (BioCartridge) combined to mimic nephron function. Here, we plan to test ONLY the material being used to construct the HemoCartridge, to be sure in humans when substituted for a standard hemodialysis filter, subjects don't develop any clinical problems or side effects during several hours of blood exposure to the material. The AK material will be engineered by the study team to allow the system to be substituted in place of a standard HD filter.
15952935|NCT03241654|Procedure|flow trigger|The flow trigger will be adjust during the pressure assist ventilation.
15952936|NCT03241641|Drug|Tenofovir Alafenamide|25mg, Daily Oral
15952937|NCT03241641|Drug|Tenofovir Disoproxil Fumarate|300mg, Daily Oral
15952938|NCT03241628|Device|Dressing Glove|Viscose dressing glove
15952939|NCT03241615|Other|Dysphagia evaluation|Dysphagia evaluation is performed in a clinical setting by an eating assessment tool. Swallowing related quality of life is also assessed.
15952940|NCT03241602|Drug|Intraperitoneal lidocaine|the investigator prepares syringes 1.75 ml/kg of 0.2% lidocaine (3.5 mg/kg) or the same volume of normal saline, for intraperitoneal administration. The solution to be instillated will be splashed under the right diaphragmatic area by the surgeon and complete the procedure.
15952941|NCT03241602|Procedure|Pulmonary Recruitment|pulmonary recruitment maneuver will be done and consist of five manual pulmonary inflations with a maximum pressure of 40 cm H2O. The anestheiologist hold the fifth positive pressure inflation for approximately 5 seconds
15952942|NCT03241602|Combination Product|Combined intraperitoneal lidocaine and pulmonary recruitment maneuver|the investigator prepares syringes 1.75 ml/kg of 0.2% lidocaine (3.5 mg/kg) or the same volume of normal saline, for intraperitoneal administration. The solution to be instillated will be splashed under the right diaphragmatic area by the surgeon and complete the procedure before the recovery of the patient pulmonary recruitment maneuver will be done and consist of five manual pulmonary inflations with a maximum pressure of 40 cm H2O. The anestheiologist hold the fifth positive pressure inflation for approximately 5 seconds
15952943|NCT03241589|Other|Direct to patient facing mobile apps introduction|VA employees begin use of OCC's direct to patient facing mobile apps.
15952944|NCT03241576|Behavioral|Small portion size provision|The intervention is the small meal size participants are provided with during a lunchtime session in the laboratory.
15952945|NCT03241576|Behavioral|Large portion size provision|The intervention is the large meal size participants are provided with during a lunchtime session in the laboratory.
15952946|NCT03241563|Drug|Sodium Deoxycholate|
15952947|NCT03241563|Drug|Triamcinolone|Triamcinolone 40mg/ml
15952948|NCT03241550|Drug|isavuconazonium sulfate - intravenous|IV infusion
15952949|NCT03241550|Drug|isavuconazonium sulfate - oral|Oral
15952950|NCT03241537|Radiation|Intensity modulated radiotherapy|
15952951|NCT03241524|Other|Exercise program for pelvic muscle floor|Pelvic muscles of each participant was evaluated by PERFECT and Peritron methods in terms of strengthening as well as sexual function response using 3 questionnaires, before and after 4 and 8 weeks from the beggining of an exercise program prescribed according to individual ratings obtained in the previous evaluation.
15952952|NCT03241511|Other|Test|Briefly, treatment sessions will include oral hygiene behavioral modification and scaling and root planning (removing the bacterial biofilm and calculus below the gum line) in order to eliminate etiologic factors and control periodontal inflammation. Once the treatment sessions are completed, the patients will enter the maintenance phase and will be followed for 6 months. In this phase, the patients will receive systematic supportive periodontal treatment (tooth cleanings above the gum line with re-enforcement of oral hygiene).
15952953|NCT03241498|Other|Medicines optimisation|
15952954|NCT03241485|Drug|Intrathecal morphine|5 micrograms/kilogram of intrathecal morphine administered in the spinal space, not to exceed 1mg
15952955|NCT03241485|Drug|Placebo|Saline intrathecal given in the same manner as the intervention groups.
15952956|NCT03241472|Drug|Letrozole|oral tablets 5 mg
15952957|NCT03241472|Drug|Clomiphene Citrate plus N acetyl cystine|Clomiphene Citrate 100 mg oral tablets+ N acetyl cystiene 600 mg
15952958|NCT03241459|Device|Surmodics SurVeil DCB|Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
15952959|NCT03241459|Device|Medtronic IN.PACT Admiral DCB|Angioplasty procedure with a paclitaxel-coated, percutaneous transluminal angioplasty (PTA) balloon catheter.
15952960|NCT03241446|Drug|Tilmanocept|Intravenously administered Technetium Tc 99m tilmanocept
15952961|NCT03241433|Other|High intensity interval training|exercise by use of stationary cycles
15952962|NCT03241433|Other|Moderate intensity continuous training|exercise by use of stationary cycles
15952963|NCT03241433|Other|No Exercise|no exercise training will be given and no exercise will be added to subjects routine
15952964|NCT03241420|Device|lung clearance index (LCI)|Determine the utility and sensitivity of the lung clearance index (LCI) technique as a marker of lung injury/small airways disease in adults with chronic lung conditions compared to health adults, adjusting for age, sex, and smoking status.
15952965|NCT03241407|Other|Placebo toothpaste|During an experimental 3-week period of undisturbed mechanical plaque accumulation in the implants, implants randomly assigned to Placebo group will be submitted to a chemical plaque control (three times per day) using a placebo toothpaste.
15952966|NCT03241407|Other|triclosan/copolymer/fluoride toothpaste|During an experimental 3-week period of undisturbed mechanical plaque accumulation in the implants, implants randomly assigned to triclosan/copolymer/fluoride group will be submitted to a chemical plaque control (three times per day) using a triclosan/copolymer/fluoride toothpaste.
15952967|NCT03241381|Diagnostic Test|vitamin D serum assay study and control groups|Serum- vitamin D assay
15952968|NCT03241381|Diagnostic Test|Photometry|Serum- Hemoglobin assay
15952969|NCT03241381|Other|Russels periodontal index|Clinical examination for periodontitis
15952970|NCT03241368|Device|Capsule Endoscopy|At baseline subject will under the PillCam Crohn's Capsule Procedure
15952971|NCT03241355|Dietary Supplement|prebiotic inulin-type fructan|
15952972|NCT03241355|Dietary Supplement|Placebo maltodextrin|
15952973|NCT03241342|Drug|GTx 024|Study drug is an opaque, white to off-white, size 5, oval Softgel capsule containing the active ingredient GTx-024.
15952974|NCT03241342|Drug|Placebo|Placebo study drug is identical in appearance to the GTx-024 study drug and contains polyethylene glycol 400 but not GTx-024.
15952975|NCT03241316|Behavioral|Observational study of behaviour|As a general population survey, our study does not involve a control group. Please note that the investigators do not interview patients; we involve only healthy members of the general public who consider themselves fit to be interviewed.
15952976|NCT03241303|Drug|Acarbose|Glucobay tablets on experimental day.
15952977|NCT03241303|Drug|Placebo Oral Tablet|Placebo tablets on experimental day.
15952978|NCT03241303|Drug|Exendin (9-39)|Infusion of GLP-1 receptor antagonist as a study tool to block GLP-1 activity on experimental day.
15952979|NCT03241303|Drug|Placebo Saline|9 mg/ml placebo saline infusion on experimental day.
15952980|NCT03241277|Procedure|Non surgical periodontal treatment|Scaling and root planning that will be performed with manual curettes or ultrasonic instruments
15952981|NCT03241264|Drug|ND-L02-s0201|Specified dose on specified day
15952982|NCT03241251|Other|questionnaire|Questionnaire of psychosocial risk factors
15952983|NCT03241238|Other|Eating|Participants will have 10 minutes to eat all of the brownie and drink 6 oz of water. They will then have 20 minutes to eat as much or as little of a meal (consisting of a sandwich, grapes and chips).
15952984|NCT03241225|Behavioral|EM/PROTECT|EM/PROTECT is a behavioral intervention for depressed elder mistreatment (EM) victims designed to work in synergy with EM mistreatment resolution services that provide safety planning, support services, and links to legal services
15952985|NCT03241225|Behavioral|EM/MH|EM/MH provides individuals experiencing elder mistreatment with support services from staff trained in linking elder mistreatment victims to community mental health services.
15952986|NCT03241212|Behavioral|Texting|From baseline appointment to 6 month follow up, those participants randomly assigned to the texting intervention will receive a text message every Monday, Wednesday and Friday. Some text messages will be informational only, others will ask the participant for a response to a multiple-choice question with immediate feedback on the answer chosen.
15952987|NCT03241199|Drug|Imatinib Mesylate|a first-generation tyrosine kinase inhibitors
15952988|NCT03241186|Drug|Ipilimumab|1mg/kg
15952989|NCT03241186|Drug|Nivolumab|3mg/kg
15952990|NCT03241186|Drug|Nivolumab|480mg
15952991|NCT03241173|Drug|INCAGN01949|In Phase 1 subjects will receive INCAGN01949 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment.
15952992|NCT03241173|Drug|Nivolumab|Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.
15952993|NCT03241173|Drug|Ipilimumab|Ipilimumab will be administered IV at the protocol-defined dose according to assigned treatment group.
15952994|NCT03241173|Drug|INCAGN01949|In Phase 1 subjects will receive INCAGN01949 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, subjects will be administered IV study drug at the recommended dose from Phase 1.
15953130|NCT03240224|Device|Cancer ablation|Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound.
15953131|NCT03240224|Drug|Life information rehabilitation therapy|Each treatment: one bottle solution each day, consecutive 3 months, oral administration
15952995|NCT03241160|Other|Chewing evaluation|Chewing evaluation will be performed. An experienced physical therapist who will take a scale training session will do the chewing evaluation according to the chewing performance scale.This scale classifies chewing function on an ordinal scale with five levels between 0 and 4 based on the sequence of functional movements during chewing.
15952996|NCT03241147|Drug|Lu AF35700|Single dose, 10 mg film coated tablet
15952997|NCT03241134|Other|Dry needling|Dry needling (DN) is a myofascial treatment technique, in which a thin, solid filiform needle is inserted directly into the MTrP. During dry needling, local twitch responses (LTR) can be elicited. These are involuntary contractions of muscle fibers, leading to muscle relaxation, an increase in blood flow,recovery of the muscle metabolism and thus a reduction of pain and stiffness.
15952998|NCT03241134|Other|Sham needling|During sham needling, a solid, filiform needle is inserted in the skin surface at the trigger point location, without penetrating the fascia and muscle tissue.
15952999|NCT03241121|Behavioral|Time restricted feeding|To eat only during a self-selected window of 12 hours, with no advice on nutrition quality, quantity or caloric intake
15953000|NCT03241121|Behavioral|Regular dietary advices|Regular dietary advices by a trained dietitian or research nurse according to current nutrition guidelines
15953001|NCT03241121|Device|Eating patterns|Data collection on eating patterns via the smartphone app
15953002|NCT03241108|Drug|NI-0101|Humanized immunoglobulin gamma 1 (IgG1) kappa monoclonal antibody targeting TLR4
15953003|NCT03241108|Other|Placebo|Placebo
15953004|NCT03241095|Procedure|OMT (Osteopathic Manipulative Treatment)|The co-hort will receive OMT. Each participant will perform 10 swings golf swings to determine a baseline measure the strength of their golf swing. This co-hort will then be evaluated by the physician and be given OMT.
15953005|NCT03241095|Procedure|Sham intervention|The co-hort participants will each perform 10 swings golf swings to determine a baseline measure the strength of their golf swing. Theythen be given a sham OMT procedure.
15953006|NCT03241082|Device|ultrasound|validation of portable ultrasound to measure body composition
15953007|NCT03241069|Other|Reference position|patient is put in a 30 degree supine position during 5 minutes
15953008|NCT03241069|Other|sitting position|patient is put to a 90 degree sitting position during 1 to 2 minutes then the CO is measured
15953009|NCT03241069|Other|Valsalva maneuver|patients are asked to perform the Valsalva maneuver by executing a forced blow into a manometer for 30 seconds and the CO is calculated during this test.
15953010|NCT03241069|Other|a passive leg rising maneuver|we make a passive leg rising and we measure the cardiac output by BIOPAC system (45 degree passive leg rising was done for 1 to 2 minutes and CO was measured during the maneuver.)
15953011|NCT03241056|Behavioral|CBT for Maladaptive Beliefs about Memory|The novel intervention is a manualized 2-session cognitive behavioural therapy. Agenda elements, including psycho-education, discussion prompts, and homework exercises are standardized across participants. In session 1, participants are taught about the cognitive theory of checking, the research support behind this theory, and how it may apply to their own checking behavior. A homework exercise is introduced and practiced to test out this theory. In session 2, the homework results are reviewed. Further education is shared on the nature of memory and the relationship to checking, and a discussion regarding how this applies to the participant's checking then takes place. A second homework exercise is introduced to test this theory.
15953012|NCT03241056|Other|Treatment as Usual|Treatment as Usual (TAU) during patients' time on our waitlist in our clinic will depend on at what point they have been recruited. It may consist of a 2-session group psychoeducational intervention on anxiety, any medications prescribed by their referring physicians, and/or independent therapy/counseling they may be seeking on the side. TAU for community participants will include any treatments they are currently seeking. Information about participation in such interventions will be collected during the course of the study (at each assessment visit) in order to accurately characterize participants' TAU in the current study.
15953013|NCT03241043|Drug|Treatment 2 weeks Envarsus followed by 2 weeks Advagraf|
15953014|NCT03241043|Drug|Treatment 2 weeks Advagraf followed by 2 weeks Envarsus|
15953019|NCT03241017|Drug|Durvalumab|Immunotherapy with Durvalumab after ASCT
15953020|NCT03241004|Other|Sleep Mask|sleep mask applied for two separate 60-minute periods during anesthesia
15953021|NCT03240991|Other|Quality of life|Dermatology Life Quality Index, Angioedema Quality of Life Questionnaire, Angioedema Activity Score
15953022|NCT03240978|Behavioral|exercise intervention|A period of 12-week exercise intervention under the supervision of exercise specialists will be conducted.
15953023|NCT03240965|Diagnostic Test|FEES (flexible endoscopic evaluation of swallowing)|Endoscopical swallowing study in stroke patients only
15953024|NCT03240965|Other|Sensitivity threshold|Determining sensitivity threshold using a pudendal electrode
15953025|NCT03240965|Diagnostic Test|Taste-/smell-test|Taste-/smell-test
15953026|NCT03240965|Diagnostic Test|Neuropsychological testing|Neuropsychological testing for neglect, agnosia
15953027|NCT03240939|Drug|Dutasteride 0.5 mg|single dose
15953028|NCT03240939|Drug|Tadalafil 5 mg|single dose
15953029|NCT03240939|Drug|YY-201|single dose
15953030|NCT03240926|Device|Loop Band|Application of Loop band on radial artery of the opposite wrist that the Anesthesiologist has placed the Arterial line.
15953031|NCT03240913|Behavioral|Baseline and Follow-up Surveys|(completed online)
15953032|NCT03240913|Other|Patient Reported Outcome Measure informed Decision Aid|(PROM-DA)
15953033|NCT03240913|Other|Pamphlet|(usual care)
15953132|NCT03240211|Drug|Pembrolizumab|Pembrolizumab 200 mg IV
15953034|NCT03240900|Device|Electrical Stimulation|Electrical stimulation - a needle attached to an cathode polarity will be placed within the intercostal space near the 4th intercostal nerve. A second needle attached to the anode polarity will be inserted into the serratus anterior muscle. Both electrodes will then be attached to a Grass SD9 stimulator and the voltage and frequency of the stimulation will be titrated to the point where contraction of the intercostal muscles is palpable. It will be maintained at this level for one hour at which point the wires will be removed. This technique is part of the standard of care for peripheral nerve surgeries of the extremities and is proven to be safe in humans.
15953035|NCT03240900|Procedure|Placebo|This breast will receive no electrical stimulation; the mastectomy and reconstruction will proceed with no intervention.
15953036|NCT03240887|Behavioral|Peer Group Connection|Faculty advisors at each participating high school are trained to run the program and teach a daily leadership course to peer leaders. Eleventh and twelfth-grade peer leaders who participate in the daily leadership development class facilitate outreach sessions with their assigned group of ninth graders. PGC can be offered in either a half-year (semester) or full-year format. In either format, a minimum of 18, 45-minute outreach sessions are expected to be offered to PGC participants during the course of their ninth-grade year. Outreaches are created to facilitate the transition to high school and encourage students to attend school, set goals for themselves, and make healthy decisions.
15953037|NCT03240874|Behavioral|SweetMama Focus Groups|Focus groups will assess tool functionality, design, interpretability, and acceptability (initial reaction, attitude, and receptiveness) of SweetMama via qualitative interviewing. The group format will generate feedback on areas that may not be revealed in a one-on-one interview.
15953038|NCT03240874|Behavioral|SweetMama Individual Testing|"Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will (1) confirm that the mobile apps are functioning (not crashing) across a wide range of devices and operating systems, (2) provide basic information about app usage and user satisfaction (3) inform the development of future iterations by analyzing participant characteristics and use, and (4) collect quality assurance data that will allow the research team to refine the applications. Women will use SweetMama for 2 weeks, engage in periodic check-ins with the research assistant, and participate in a semi-structured interview upon completion of SweetMama usage."
15953039|NCT03240874|Behavioral|SweetMama Feasibility Testing - Pilot Randomized Trial|"Women will be oriented to SweetMama use on their own Android- or Apple-based phones. The goals of this phase are to collect data from diverse users that will determine acceptability, feasibility, and pilot procedures in anticipation of a fully powered randomized controlled trial. Women will use SweetMama from enrollment (early pregnancy) to up to 8 weeks postpartum, engage in periodic check-ins with the research assistant, and participate in surveys and a semi-structured interview upon completion of SweetMama usage."
15953040|NCT03240861|Other|18F-FHBG|Given IV
15953041|NCT03240861|Biological|Aldesleukin|Given SC
15953042|NCT03240861|Drug|Busulfan|Given IV
15953043|NCT03240861|Biological|Cellular Therapy|Given LV-NYESO TCR/sr39TK PBSC IV and RV-NYESO TCR PBMC IV
15953044|NCT03240861|Procedure|Computed Tomography|Undergo PET/CT
15953045|NCT03240861|Biological|Filgrastim|Given SC
15953046|NCT03240861|Drug|Fludarabine|Given IV
15953047|NCT03240861|Procedure|Leukapheresis|Undergo leukapheresis
15953048|NCT03240861|Drug|Plerixafor|Given SC
15953049|NCT03240861|Procedure|Positron Emission Tomography|Undergo PET/CT
15953050|NCT03240848|Procedure|artificial intelligent clinic|Participants in group A assigned to artificial intelligent clinic to get the initial diagnosis after the eye examinations, including images of ocular anterior segment.
15953051|NCT03240848|Procedure|normal clinic|Participants in group B assigned to normal clinic to get the initial diagnosis after the eye examinations, including images of ocular anterior segment.
15953052|NCT03240848|Procedure|experts diagnose|After making the initial diagnosis, participants went to get the final definite diagnosis from experts with more than 10 years of clinical experience.
15953053|NCT03240835|Drug|cisplatin and docetaxel|"NACt：cisplatin 75 mg/m2 intravenous infusion in day1，docetaxel 75 mg/m2 intravenous infusion in day1，both drugs are given every 3 weeks, two cycles.
~CCRT: cisplatin (100mg/m2 on day 1) every three weeks for two cycles."
15953054|NCT03240835|Radiation|IMRT|intensity modulation radiation therapy
15953055|NCT03240822|Procedure|Penile Transplant|Penile Allotransplantation
15953056|NCT03240822|Biological|Monoclonal Antibody (Humanized Anti-CD52)|
15953057|NCT03240822|Drug|Tacrolimus|
15953058|NCT03240809|Biological|Brodalumab|140 mg SC dose
15953059|NCT03240809|Biological|Brodalumab|70 mg SC dose
15953060|NCT03240796|Procedure|minimal invasive surgery and secondary IOL implantation|We decreased the size of the capsulorhexis opening to 1.0-1.5 mm in diameter and moved the location of the capsulorhexis to the peripheral area of the lens instead of the central area. A 0.9 mm phacoemulsification probe was used to remove the lens contents and/or cortical opacities. Secondary IOL implantation: implant the IOL either into the capsule bag or fix at the ciliary sulcus.
15953061|NCT03240796|Procedure|traditional cataract surgery and secondary IOL implantation|"traditional cataract surgery: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy (ACCC+ I/A + PCCC + Anti-vit).
~Secondary IOL implantation: implant the IOL either into the capsule bag or fix at the ciliary sulcus."
15953062|NCT03240783|Drug|Betamethasone OR Dexamethasone Injectable|Procedural agents. The steroid and local anaesthetic preparation will be standardized to replicate current radiology interventional practices that use either particulate or non-particulate steroids. Betamethasone Sodium Phosphate/Acetate 5.7 mg/ml Injectable is a particulate corticosteroid and is used with the local anaesthetic bupivacaine 0.5% (1ml). Dexamethasone 4mg (1ml) is a non-particulate corticosteroid and is used with the local anaesthetic lignocaine 1% (1ml).
15953063|NCT03240783|Drug|Normal Saline Flush, 0.9% Injectable Solution|Procedural agents. The local anaesthetic preparation used with the Normal Saline Flush, 0.9% Injectable Solution, will be standardized to replicate current radiology interventional practices: either local anaesthetic bupivacaine 0.5% (1ml) or local anaesthetic lignocaine 1% (1ml).
15953064|NCT03240783|Drug|Dexamethasone Oral Tablet|Dexamethasone Oral Tablet: 15 day taper dosing is: days 1-5 8mg (4mg bd) , days 6-10 4 mg (2mg bd), and days 11-15 2 mg (1mg bd). The dexamethasone is over-encapsulated in a gelatine capsule that is identical to the placebo capsule in appearance.
15953068|NCT03240757|Dietary Supplement|Breakfast|All subjects received a standard 75-g OGTT to assess eligibility for the study. The 19 subjects matching the inclusion criteria completed 2 experimental trials: resting and exercise. During the resting trial, all subjects underwent an OGTT (50-g: A) and 3 meal tolerance tests [one for each breakfast tested: B1 = milk (125ml) and cereals (30g); B2 = milk (220ml), apple (200g) and chocolate cream-filled sponge cake (30g); B3 = milk (125ml), apple (150g), bread (50g) and hazelnut chocolate cream (15g)]. In the exercise trial, 100 minutes after the glucose/meal ingestion, participants cycled for 20 min at 40% of maximum oxygen uptake.
15953069|NCT03240757|Other|exercise|aerobic exercise at 40% of VO2max, for 20 minutes
15953070|NCT03240744|Biological|Inactivated EV71 vaccine (human diploid cell, KMB-17)|3.0 EU of inactivated enterovirus 71 vaccine (KMB-17) on day 0, 28.
15953071|NCT03240731|Biological|bone marrow transplant|haploidentical bone marrow transplant
15953072|NCT03240718|Procedure|Laser treatment|CORE fractional CO2 laser treatment
15953073|NCT03240705|Behavioral|Gratitude journaling|Gratitude journaling 3 times a week during surgical rotation
15953075|NCT03240679|Device|Extracellular Matrix|ECM are composed of collagen and natural proteins that provide a re-absorbable scaffold for tissue remodeling have been investigated in preclinical as well as clinical pilot studies and found to facilitate constructive healing following EMR
15953076|NCT03240666|Other|non applicable|non applicable
15953077|NCT03240653|Other|Stratified response to Enzyme Therapy|Observational study involves review of retrospective and prospective data of participants' medical history, pathology, imaging and health questionnaires.
15953078|NCT03240640|Procedure|Inspiratory Muscle Strength Training|IMT will be performed using a variable flow resistive loading device (POWERbreathe®KH1, HaB International Ltd., Southam, UK). The device is able to store training parameters of up to 40 sessions. Most training sessions during this RCT will be performed by patients at their homes without supervision. The intervention group (strength IMT) will perform two daily sessions of 30 breaths. Measurements of Pi,max will be performed every week and training loads will be increased continuously to maintain at least 40-50% of the actual Pi,max values. Each week, one training session will be performed under supervision. Training load will be increased during this session.
15953079|NCT03240640|Procedure|Inspiratory Muscle Endurance Training|IMT will be performed using a variable flow resistive loading device (POWERbreathe®KH1, HaB International Ltd., Southam, UK). The device is able to store training parameters of up to 40 sessions. Most training sessions during this RCT will be performed by patients at their homes without supervision. The sham group (endurance IMT) will perform three daily sessions of 30 breaths and will train at a constant inspiratory load of no more than 10% of their initial Pi,max. Each week, one training session will be performed under supervision.
15953080|NCT03240627|Drug|LH-8|LH-8 cutaneous solution
15953081|NCT03240627|Drug|Placebo|Placebo cutaneous solution
15953082|NCT03240614|Device|Non-rebreather oxygen mask|This intervention will be preoxygenation using a Non-rebreather that will be placed upon the participant for preoxygenation. The oxygen flow will be set at 60 L/min and the participant will be preoxygenated for a total of 3 minutes. After 3 minutes, an ABG will be taken and labeled as Intervention A.
15953083|NCT03240614|Device|Bag-valve-mask|This intervention will be preoxygenation using a BVM apparatus for preoxygenation for 3 minutes. At the end of 3 minutes an ABG will be obtained.
15953084|NCT03240614|Device|High Flow Nasal Cannulae|This intervention will be preoxygenation using High Flow Nasal Cannulaes at an FiO2 of 100%. The oxygen flow will be set at 60 L/min and the participant will be preoxygenated for a total of 3 minutes. After the 3 minutes, an ABG will be taken and labeled as Intervention C.
15953085|NCT03240601|Device|Transcutaneous spinal cord stimulation|For tcSCS, a transcutaneous electrical nerve stimulation (TENS) unit is used. A 2 inch diameter round electrode is placed on the skin over T11/T12 (cathode), and a large butterfly electrode is placed on the skin over the umbilicus (anode). Pulse width is set to 400 microseconds at 50 Hz.
15953086|NCT03240588|Device|Neurostimulation System|Spinal cord stimulation
15953087|NCT03240575|Drug|Tiotropium|Fixed Dose Combination
15953088|NCT03240575|Drug|Olodaterol|Fixed Dose Combination
15953089|NCT03240575|Drug|Fluticasone propionate|Fixed Dose Combination
15953090|NCT03240575|Drug|Salmeterol|Fixed Dose Combination
15953091|NCT03240562|Procedure|serratus anterior plane block|before surgery :ultrasound-guided serratus anterior plane block
15953092|NCT03240562|Drug|patient controlled analgesia|two groups have same intravenous patient controlled analgesia
15953093|NCT03240549|Drug|bevacizumab|The patients in conventional group continued the previous chemotherapy,and the patients in experimental group received adding bevacizumab to previous chemotherapy regimen.
15953094|NCT03240536|Other|Choosing Wisely form|"The investigators will fax a Choosing Wisely form to ordering physicians that will include information from the Canadian Rheumatology Association Canada Choosing Wisely Guidelines. Three points will be included with some additional explanation of why these are important.
~The three guidelines included will be:
~Don't order an ANA as a screening test in patients without specific signs or symptoms of systemic lupus erythematous (SLE) or another connective tissue disorder (CTD).
~Don't routinely image patients with low back pain regardless of the duration of symptoms unless that are clinical reasons to suspect serious underlying pathology
~Don' routinely order a shoulder ultrasound as it is likely to indicate a tear in many people over the age of 50 years and will not change the initial management."
15953095|NCT03240523|Drug|Vilaprisan (BAY1002670)|Orally, 2 mg, once daily
15953096|NCT03240497|Behavioral|Cold Exposure|"The start of the training is scheduled 7 to 12 days before the endotoxemia experiment day. Subjects in this group will participate in a 4 day intensive cold exposure course (see section 5.1). On day 1, venous blood will be sampled directly after ice water immersion. On day 4, venous blood will be sampled before the training procedures on that day and after the last ice water immersion.
~After the 4 day course, subjects will continue to practice cold exposure at home using cold showers. The timing and length of this training is analogous to the time spend on training in the cold in our previous study protocol [7]."
15953097|NCT03240497|Behavioral|Strength Ventilation|The training is scheduled 2 to 6 days before the endotoxemia experiment day. Subjects in this group will receive a detailed, written instruction about the strength ventilation technique (see section 5.1). In addition, they will receive a 2 hour instruction session during which the research team will supervise the practices and clarify the instructions of needed. Subjects are instructed not to practice the learned techniques at home.
15953098|NCT03240484|Diagnostic Test|X-Ray Imaging|X-Ray imaging in the following positions: Lateral standing, lateral seated, standard standing AP pelvis and AP pelvis lying down.
15953099|NCT03240484|Other|Gait Analysis|Certain patients may be asked to participate in a motion analysis procedure at the Human Movement Laboratory at the University of Ottawa. This procedure takes approximately 1.5 hours and you will only be asked to participate in the motion analysis procedure once. Participants will change into a custom-designed tight body suit, which has reflective markers on its surface for infrared video capture. Participants will then have pairs of surface electromyography (EMG) electrodes placed on certain areas of the skin on the legs and on the back. Wearing the EMG electrodes and marker suit, participants will perform 5 trials of walking on a level walkway, walking up and down a 3-step staircase, sitting from a standing position, and standing from a seated position.
15953100|NCT03240471|Procedure|One week of plaster cast|One week of plaster cast as treatment for a non-reduced distal radius fracture.
15953101|NCT03240471|Procedure|Four-Five weeks of plaster cast|Four-Five weeks of plaster cast as treatment for a non-reduced distal radius fracture.
15953102|NCT03240458|Device|Optical Coherence Tomography|an objective non-invasive method for high-resolution cross-sectional imaging of the retina
15953103|NCT03240445|Drug|ODM-203 (Period 1)|ODM-203 400mg as tablets taken 30 minutes after food
15953104|NCT03240445|Drug|ODM-203 (Period 2)|ODM-203 400mg as tablets taken 1 hour before a light breakfast
15953105|NCT03240445|Drug|ODM-203 (Periods 3-6)|ODM- 203 400mg as tablets for oral administration or 400mg as oral dispersion either before/after food
15953106|NCT03240432|Device|Dexcom CGM|CGM group will be instructed on how to utilize the CGM data for diabetes management. Participants will be encouraged to use CGM values for making diabetes management decisions and will be provided guidelines for when to confirm with a study BGM fingerstick.
15953107|NCT03240419|Dietary Supplement|Probiotics|Bifidobacterium BB12 and Lactobacillus Rhamosus LGG (50%:50%) capsules.
15953108|NCT03240419|Dietary Supplement|Placebo|capsule manufactured to mimic probiotic capsules.
15953109|NCT03240406|Other|Multicultural Healthy Diet|An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential
15953110|NCT03240406|Other|Usual Diet plus Self-Care|Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
15953111|NCT03240393|Drug|INC280|cMET GCN ≥ 6 cMET GCN ≥ 4 and < 6 cMET mutations
15953112|NCT03240380|Behavioral|joint crisis plan|"Joint crisis plans are consensual written patient-clinic-agreements for future crisis intervention, especially for people with recurring severe mental illnesses. In case of relapse, they provide the hospital with contact information and detailed patient's preferences regarding medical, psychological and psychosocial measures. Thus JCPs aim to implement patient self-determination rights, prevent psychiatric coercion and foster self-management and recovery.
~Between the patient and the clinic represented by the attending physician a joint crisis plan is to be negotiated and agreed upon on individual basis as part of inpatient care. If possible this is to be facilitated by peer counselors or another third party. If for an in-patient the process is not completed until the end of the hospital stay it becomes part of regular outpatient aftercare."
15953113|NCT03240380|Behavioral|crisis card|"Crisis cards are credit card-sized booklets to be kept preferably always at hand. They can contain important information: persons to contact, current medication, basic treatment preferences and hints to advance directives or other existing legal documents. They may be of use in the event of a mental health crisis and help to quickly receive appropriate support.
~When the in-patient is to be released from the clinic, the attending physician and the patient together fill out a crisis card. Out-patients get their crisis cards during the next routine visit to their clinic doctor's office."
15953114|NCT03240367|Other|Coutery|Stapler line bleeding control with coutery
15953115|NCT03240354|Device|Saline cuff|Cuff of endotracheal tube inflated with saline rather than air (control)
15953116|NCT03240354|Device|Control|Cuff of endotracheal tube inflated with air
15953117|NCT03240341|Behavioral|Patient Activation Measure Questionnaire|Measure the level of patient engagement in cancer care pathway
15953118|NCT03240328|Biological|CAR-T cells|HIV-1 specific chimeric antigen receptor cells
15953119|NCT03240302|Device|ICSI petri dish|Half of the oocytes will be placed into the standard ICSI petri dish and they will be injected with sperm with normal morphology.
15953120|NCT03240302|Device|PICSI petri dish|Half of the oocytes will be placed into a PICSI petri dish (whose bottom is coated with hyaluronic acid) and the mature spermatozoa with CD44 receptors that are attached to the bottom of the dish will be injected into them.
15953121|NCT03240289|Behavioral|Texting group|Women receive text messages to aid in their diabetes self-care tasks during pregnancy; these included appointment reminders, motivational messages, and nutrition/exercise tips.
15953122|NCT03240276|Other|Standard ICSI procedure for sperm injection into oocyte|The ICSI procedure is the standard procedure of selection and injection of sperm into oocytes
15953123|NCT03240276|Device|MSOME|Selection of ultramorphologically normal spermatozoa using an inverted microscope with 6300x magnification
15953124|NCT03240276|Other|IMSI Procedure|Injection of sperm that has been selected by the MSOME method into oocytes
15953125|NCT03240263|Procedure|Inspiratory Muscle Training|"Supervised daily sessions of training including 4 sets of 6-10 breaths using a tapared flow resistive load device*. Resistance adjusted to the highest tolerable load.
~*Electronic Variable Flow Resistive Loading IMT Device/ POWERbreathe®KH1, HaB International Ltd., Southam, UK"
15953126|NCT03240263|Procedure|Endurance training|"Supervised daily sessions of training including 4 sets of 6-10 breaths using a tapared flow resistive load device*. Low training resistance adjusted to <10% maximal inspiratory pressure.
~*Electronic Variable Flow Resistive Loading IMT Device/ POWERbreathe®KH1, HaB International Ltd., Southam, UK"
15953127|NCT03240250|Procedure|VATS uni-portal lobectomy and lymphoadenectomy|VATS uni-portal lobectomy and lymphoadenectomy
15953133|NCT03240211|Drug|Pralatrexate|Pralatrexate 20 or 30 mg/m2 IV push
15953136|NCT03240159|Drug|Degarelix|"Degarelix 24mg Degarelix 16mg Degarelix 12mg
~Active Comparator:
~Down regulation of LH, during exposing in three different doses of Degarelix"
15953137|NCT03240146|Device|Pulsed Shortwave Therapy|Pulsed Shortwave Therapy device
15953138|NCT03240133|Drug|BCX7353|oral liquid formulation
15953139|NCT03240133|Drug|Placebo|oral liquid formulation to match BCX7353
15953140|NCT03240120|Drug|Dabigatran etexilate|Pradaxa 150 mg hard capsules
15953141|NCT03240120|Drug|Tinzaparin|Tinzaparin 175 iu/kg daily will be started after the diagnosis of VTE is confirmed
15953142|NCT03240107|Procedure|levator resection|"The levator aponeurosis was dissected from the upper border of the tarsal plate and conjunctiva.
~The aponeurosis was measured for the desired amount of resection and fixed to the exposed tarsal border with three point mattress sutures with 6-0 prolene then amount measured resect.
~The skin incision closed by continuous suture with 6-0 prolene."
15953143|NCT03240107|Procedure|levator tucking|"The levator aponeurosis was dissected from the upper border of the tarsal plate and conjunctiva.
~. The aponeurosis was measured for desired amount of tucking The skin incision closed by continuous suture with 7-0 prolene."
15953144|NCT03240094|Other|Nutritional telemonitoring|Participants receive a weighing scale, pedometer and television channel in order to perform self measurements and receive guidance on nutrition and physical activity. Nurses use a website in order to receive telemonitoring measurements and decide about proper follow-up. In case of risk of undernutrition, nurses provide personal advice to optimize nutritional status of the participant.
15953145|NCT03240081|Drug|50mcg estradiol cream|Use of study drug nightly applied to vulvar vestibule
15953146|NCT03240081|Drug|100mcg estradiol cream|Use of study drug nightly
15953147|NCT03240068|Drug|Angiotensin 1-7|This is a biologically active hormone of the renin-angiotensin system. It may play a beneficial role in regulation of blood pressure by dilating blood vessels and reducing inflammation.
15953148|NCT03240068|Drug|Saline|Normal saline will be used as the placebo comparator.
15953149|NCT03240055|Drug|spinal anesthesia|The spinal puncture was performed with a 25 G Sprotte needle at the L3-4 or L2-3 interspinous space. Hyperbaric bupivacaine 0.5% (3 ml) was administered into the spinal space. Hyperbaric bupivacaine is obtained through the addition of glucose 10% (1ml) to bupivacaine 0.75% (2ml). Cerebrospinal fluid aspiration (0.1 ml) was done to confirm correct needle placement before and after spinal drug administration. Whereafter the patient was turned rapidly to the supine position, sensory anesthesia height was evaluated bilaterally using a pinprick test with the sharp tip of a safety pin every 1 min until 15 min after the initiation of the spinal anesthesia, bed tilting (upwards, horizontal, or downwards) was performed until bilateral sensory anesthesia level was confirmed to remain at the T4-T6 level
15953150|NCT03240055|Other|etomidate|receive etomidate only
15953151|NCT03240042|Procedure|nasotracheal intubation|The participants either receive intubation via nasal route.
15953152|NCT03240042|Procedure|orotracheal intubation|The participants either receive intubation via oral route.
15953153|NCT03240029|Other|Questionnaires|SPP questionnaire (Self Perception Profile for Children), Systemic inventory of life quality for children (ISQV-E), Anxiety questionnaire (STAI-C), Depression questionnaire (CDI)
15953154|NCT03240016|Drug|Pembrolizumab|200mg IV D1
15953155|NCT03240016|Drug|Abraxane|100mg/m^2 D1 and D8
15953156|NCT03240003|Behavioral|GC-MRT|Group 1 will receive a 4-week (8-sessions) course of GC-MRT
15953157|NCT03240003|Behavioral|modified GC-MRT|group 3 will receive a 4-week (8-sessions) course of GC-MRT, modified
15953158|NCT03240003|Behavioral|Non-GC-MRT|Group 2 will receive a 4-week (8-sessions) course of non-GC-MRT
15953159|NCT03239990|Behavioral|Incredible Years, Parent group supported by home visiting|Parents are taught to use positive and consistent strategies in reducing child misbehavior
15953160|NCT03239977|Behavioral|Online Social Intelligence Training|The SII consists of short 5-10 minute sessions organized into 7 modules designed to raise awareness of human nature and social relationships. The approach is based on evidence that SII is best advanced through interventions that modify key social cognitions regarding social engagement and enhance efficacy expectations regarding performance in social situations.
15953161|NCT03239977|Behavioral|Attention Control (AC)|A placebo condition delivered online to both custodial grandmothers and their adolescent grandchild which presents health-related information only.
15953162|NCT03239964|Drug|Dexamethasone|the wound edges are injected once with dexamethasone. A 1 mL syringe with a 30-gauge needle is used and injection is both intradermal and subdermal. Repeated alternate punctures are used to bathe the wound edges with the drug. Approximately 0.5-1 mL of dexamethasone (4 mg/mL) in wound tissue.
15953163|NCT03239964|Other|surgical excision|total extralesional surgical excision of the keloid is performed and minimal undermining
15953164|NCT03239951|Device|iTind|temporary implant
15953165|NCT03239938|Behavioral|Modern pain neuroscience approach|The modern pain neuroscience approach includes 3 sessions (1 group and 2 individual sessions) of therapeutic pain neuroscience education followed by 15 individual sessions of dynamic and functional cognition-targeted exercise therapy and stress management techniques. In addition, participants will be instructed to perform a daily set of home exercises. The exercises will be performed in a time-contingent way. The 18 sessions will be spread over a period of 16 weeks.
15953166|NCT03239938|Behavioral|Usual care evidence-based physiotherapy|The usual care evidence-based physiotherapy includes 3 sessions (1 group and 2 individual sessions) of neck school followed by 15 individual sessions of graded and active exercise therapy focusing on strength, flexibility, endurance, and ergonomic principles. In addition, participants will be instructed to perform a daily set of home exercises. The exercises will be performed in a symptom-contingent way. The 18 sessions will be spread over a period of 16 weeks.
15953167|NCT03239925|Radiation|Electromagnetic field of cell phone in ''on'' mode.|In experimental group, participants would hold a cell phone to their left ears in their left hands, in 'on' mode, for 15 min, and that they would thus be exposed to a 900-1800 MHz magnetic field (EMW) for 15 min.
15953168|NCT03239925|Radiation|Electromagnetic field of cell phone in 'off' mode.|In control group, participants would hold a cell phone to their left ears in their left hands for 15 min in 'off' mode.
15953169|NCT03239912|Device|Twin-block appliance|Functional treatment will be achieved using the Twin-block appliance
15953170|NCT03239912|Other|Low level laser|Functional treatment will be combined with low-level laser therapy on the TMG region
15953171|NCT03239899|Drug|Pembrolizumab|Participants will receive one dose of 2mg/kg of pembrolizumab IV at week 0.
15953172|NCT03239886|Other|imatinib discontinuation|imatinib discontinuation
15953173|NCT03239873|Biological|VARIVAX® PE34 Process|Varicella virus vaccine live manufactured with a new passage extension process (PE34)
15953174|NCT03239873|Biological|VARIVAX® 2016 Commercial Process|Varicella virus vaccine live manufactured with the 2016 commercial process
15953175|NCT03239873|Biological|M-M-R II®|Measles, Mumps, and Rubella virus vaccine live
15953176|NCT03239860|Drug|GNbAC1 Monoclonal Antibody|Monthly IV
15953177|NCT03239847|Other|EndoPhys Sheath and Radial Arterial Line|
15953178|NCT03239847|Other|EndoPhys Sheath|
15953179|NCT03239834|Device|OncAlert|A noninvasive point of care salivary rinse test performed as 1) a one-time test for patients presenting with suspicion of OPMD and scheduled for biopsy and 2) a multi-administered test for patients presenting with suspicious lesions not scheduled for biopsy.
15953180|NCT03239821|Device|VIPUN Balloon Catheter 0.1 deflated|deflation balloon
15953181|NCT03239821|Drug|Codeine Phosphate|58.8 mg codeïne phosphate
15953182|NCT03239821|Drug|Placebo|Sirupus Simplex
15953183|NCT03239821|Device|VIPUN Balloon Catheter 0.1 inflated|VIPUN Balloon Catheter 0.1 inflated
15953184|NCT03239808|Procedure|Incremental haemodialysis|It consists in reducing the frequency or number of sessions per week with which patients start the HD treatment. The experimental group will start with one session/week, then the number of weekly sessions will be increased to two and later to three as per criteria for progression
15953185|NCT03239808|Procedure|Conventional haemodialysis|It is controlled through usual clinical practice, based on starting the HD treatment with three sessions per week (control group).
15953186|NCT03239795|Other|Advertisement|Advertisement by means of a poster and pamphlets in FP waiting rooms, removing all the other posters and pamphlets (except mandatory information, like opening hours, fees, etc.)
15953187|NCT03239782|Behavioral|Calorie restriction|Calorie restriction with behavioral modification and provision of one catered, reduced calorie meal a day
15953188|NCT03239769|Procedure|thyroidectomy|Thyroidectomies have different approaches. The aim of this study was to evaluate and compare the aesthetic effects of different access procedures in patients with differentiated thyroid carcinoma (DTC).
15953189|NCT03239756|Biological|TK006|Subcutaneous injection
15953190|NCT03239743|Device|Virtual Reality|Child will wear and interact with virtual reality headset while waiting for surgery.
15953191|NCT03239743|Drug|Midazolam|Child will receive Midazolam to help with pre-operative anxiety prior to surgery
15953192|NCT03239717|Other|Whey protein powder|Participants in the Control Arm will replace two-thirds of participants dietary protein intake with a commercially available whey protein powder.
15953193|NCT03239717|Other|BCAD2|Participants in the Experimental Arm will replace two-thirds of participants dietary protein intake with BCAD2 (Mead Johnson), a BCAA-free medical food.
15953194|NCT03239704|Behavioral|Telemedicine Follow-Up|Organized follow-up with an IBD advanced practice nurse at 24-48 hours, 7 days, and 30 days post-urgent care clinic appointment; to monitor the health status of patients with respect to their IBD.
15953195|NCT03239704|Other|Telemedicine Monitoring|Patients will be provided access to a smartphone application entitled: 'Health Promise'. The application will generate short questionnaires every 3 days, where patients can self-report their Crohn's disease activity as measured by the PRO-2 score or Ulcerative Colitis activity as measured by the 6-Point Mayo score, and medication adherence as measured by the MMAS-8 scale. The survey responses will be monitored by an IBD advanced practice nurse, to arrange for additional telemedicine follow-up sessions or to triage patients for an expedited appointment with a gastroenterologist.
15953196|NCT03239704|Behavioral|30 Day Comprehensive Questionnaire|Patients will complete a web-based questionnaire at 30 days following the urgent care clinic visit when they were enrolled in the study. The questionnaire will query the following: Patient Demographics; Patient Satisfaction as measured by the CACHE Questionnaire; IBD related Quality of Life as measured by the IBDQ questionnaire; and Crohn's Disease activity as measured by the PRO-2 score or Ulcerative Colitis Activity as measured by the 6-Point Mayo score.
15953197|NCT03239691|Drug|ACT-709478 for oral use|Hard gelatin capsules for oral administration formulated at strengths of 10 mg and 100 mg
15953198|NCT03239691|Drug|Placebo|Matching placebo available as matching capsules for oral administration
15953199|NCT03239678|Drug|100% Oxygen|Conventional preoxygenation with 100% oxygen
15953200|NCT03239678|Drug|30% Oxygen|preoxygenation with 30% oxygen
15953201|NCT03239678|Drug|21% Oxygen|preoxygenation with 21% oxygen
15953202|NCT03239678|Drug|40% Oxygen|preoxygenation with 40% oxygen
15953203|NCT03239678|Drug|60% Oxygen|preoxygenation with 60% oxygen
15953204|NCT03239678|Drug|80% Oxygen|preoxygenation with 80% oxygen
15953205|NCT03239665|Behavioral|Pharmacist-led Intervention (PHARM)|60 minute didactic lecture about vaccinations.
15953206|NCT03239665|Behavioral|Peer-led Intervention (PEER)|60 minute peer led small group intervention including skits and other educational material
15953207|NCT03239652|Device|Taiwan ACE Beads|Similar with conventional Transcatheter Arterial chemo-embolization, radiologist use Taiwan ACE Beads instead of Gelfoam or polyvinyl alcohol.
15953208|NCT03239639|Behavioral|Advance care planning education session|Administration of values clarification tool, elicitation of preference for treatment options, if preference for resuscitation, shown an educational video about cardiopulmonary resuscitation, summary document of values and preferences created by a facilitator to share with doctor
15953209|NCT03239639|Other|Wait list control|No intervention
15953210|NCT03239626|Radiation|POHIM-RT|postoperative adjuvant IMRT with hypofractionation (2.5 Gy/fraction, 16 fractions, once a day)
15953211|NCT03239613|Other|POHIM-CCRT|postoperative adjuvant concurrent chemotherapy with hypofractionated IMRT (2.5 Gy/fraction, 16 fractions, once a day)
15953212|NCT03239600|Drug|GSK2618960 2 mg/kg|GSK2618960 solution for injection, 100mg/mL is clear to opalescent, colorless to yellow or pale brown liquid.
15953213|NCT03239600|Drug|Placebo|Placebo solution will be administered by IV infusion.
15953214|NCT03239600|Drug|Methotrexate|MTX dose between 7.5 to 15 mg will be administered in tablet form once in a week till last dose of GSK2618960 to all subjects in Part I and Part II.
15954050|NCT03233217|Biological|QIV-HD by IM|IM, injected into the upper arm (deltoid area)
15953215|NCT03239587|Behavioral|Musical Intervention|Participants wait for 30 minutes in waiting area with a Steinway Spirio grand piano that plays 30 minutes of simulated piano music.
15953216|NCT03239587|Procedure|Blood Draws|"No Musical Intervention - Control Group: Blood drawn before, and about 30 minutes after participant stands in the waiting room without music.
~Musical Intervention Group: Blood drawn before, and about 30 minutes after in waiting room with a Steinway Spirio grand piano that plays 30 minutes of simulated piano music."
15953217|NCT03239587|Behavioral|Questionnaires|Participants complete 2 questionnaires about anxiety and stress levels. It should take about 20-30 minutes to complete.
15953218|NCT03239574|Device|MightySat|MightySat - investigational pulse oximeter that will be placed on the subject's right index finger for the duration of the study
15953219|NCT03239561|Drug|[18F]MNI-1020|Participants will receive a single intravenous bolus injection of [18F]MNI-1020 at a dose of not more than 10 millicurie (mCi), with a maximum mass dose of 10 microgram (mcg) and maximum volume of 10 milliliter (mL) at imaging visit.
15953220|NCT03239535|Biological|Mesenchymal stem cells|Intramuscular injection
15953221|NCT03239535|Biological|Normal saline|Intramuscular injection
15953222|NCT03239522|Drug|[14C]-GSK1278863 solution for IV infusion|It is a clear, colorless solution free from visible particulate matter. Participants will receive 10 mL of 5 µg/mL of [14C]-GSK1278863 IV solution (total dose: 50 µg) by IV infusion over 1 hour.
15953223|NCT03239522|Drug|[14C]-GSK1278863 oral solution|It is a clear, colorless solution. Participants will receive 125 mL of 200 µg/mL of [14C]-GSK1278863 oral solution (total dose: 25 mg).
15953224|NCT03239522|Drug|Daprodustat 6 mg oral tablet|It is a 9.0 millimeter (mm) round, white film coated tablet.
15953225|NCT03239509|Procedure|bioprosthesis implantation between 2000-2015|Implantation of a bioprosthesis in aortic position with cardiopulmonary bypass
15953226|NCT03239509|Procedure|mechanical prosthesis implantation between 2000-2015|Implantation of a mechanical prosthesis in aortic position with cardiopulmonary bypass
15953227|NCT03239496|Biological|IPV|Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
15953228|NCT03239496|Biological|f-IPV|Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
15953231|NCT03239470|Biological|Cohort 1: 1.0 x 10^8 PolyTregs|Each participant will receive a target cell dose of 1.0 x 10^8 polyclonal Tregs.
15953232|NCT03239470|Biological|Cohort 2: 2.5x10^8 PolyTregs|Each participant will receive a target cell dose of 2.5x10^8 polyclonal Tregs.
15953233|NCT03239457|Biological|Heberprot P|75 µg vials administered at the rate of a vial 3 times per week (Sunday Tuesday, Thursday) by intralesional and perilesional route.For this, the reconstitution and dilution of the vial will be carried out with 5 mL of water for injection. The administrations will be kept up to 8 weeks of treatment or until there is achieved granulation of the 100 % of the lesion.
15953234|NCT03239444|Device|Intracardiac echocardiography imaging|Wide visualization of the the heart anatomy and additional devices used during atrial fibrillation ablation procedures.
15953235|NCT03239431|Other|asthmatic exacerbation|evaluate the risk factors, frequency and nature of asthma exacerbations
15953236|NCT03239418|Device|Neuromuscular electrical stimulation|A low level electrical current is applied to the muscle that control eyelid function through small electrodes applied to the skin over the target muscles. Treatment is applied daily for 5 consecutive days and exercises for eyelid function are performed in conjunction with the stimulation.
15953237|NCT03239418|Device|Sham neuromuscular electrical stimulation|Electrodes are applied to the skin over the target muscles and patient perform the exercises for eyelid function for 5 consecutive days just as in the experimental group, However participants do not receive the electrical stimulation. Due to the low intensity of the stimulation all participants regardless of group allocation are told they may or may not feel the electrical stimulation.
15953238|NCT03239405|Device|Suction callibrated system|One-step suction callibrated SG system
15953239|NCT03239392|Drug|BNZ132-1-40|Injectable PEGylated peptide antagonist that binds to the common gamma chain (γc) signaling receptor for the cytokines interleukin (IL)-2, IL-9, and IL-15
15953240|NCT03239379|Drug|BNZ132-1-40|Injectable peptide antagonist of IL-2, IL-9 and IL-15
15953241|NCT03239379|Drug|Placebo|Normal Saline
15953242|NCT03239366|Other|BioK+ 100% probiotic|The active BioK+ product will include the 3 strains of Lactobacillus: L. acidophilus CL1285®, L. casei LBC80R® and L. rhamnosus CLR2®, representing the bacteria found in Bio-K+ probiotic capsules 50B®;
15953243|NCT03239366|Other|Placebo|The placebo product will NOT include the 3 strains of Lactobacillus: L. acidophilus CL1285®, L. casei LBC80R® and L. rhamnosus CLR2®, representing the bacteria found in Bio-K+ probiotic capsules 50B®;
15953244|NCT03239353|Drug|Entecavir|Study drug (entecavir or placebo) will be administered with 240 mL of water following an overnight fast (no food or drink, except water, for at least 10 hours). Subjects will be required to fast (no food or beverages other than water) until after collection of the 4-hour blood draw.
15953246|NCT03239327|Drug|Misoprostol|
15953247|NCT03239314|Drug|Saline Solution|Injected in the adductor canal
15953248|NCT03239314|Drug|Dexamethasone|Injected in the adductor canal
15953249|NCT03239301|Procedure|Conventional Rehabilitation|Conventional rehabilitation program consisted range of motion (ROM) exercises, balance and coordination training, progressive resistive exercises, posture training, gait training, and occupational therapy as much as the patients tolerated. Conventional rehabilitation was tailored to the patient considering his requires and expectancies.
15953288|NCT03239054|Behavioral|Physical activity|pregnancy prescription for physical activity as part of prenatal care can increase healthy exercise behaviors during pregnancy
15953289|NCT03239054|Behavioral|Control group|Information will be given as part of standard care
15953290|NCT03239041|Behavioral|Social navigation team|Social navigation team
15953291|NCT03239028|Behavioral|Observational|
15953250|NCT03239301|Procedure|Robotic REhabilitation|The Armeo Spring HocomAG Inc. (Volketswil, Switzerland) device was used in robot assisted upper limb rehabilitation program. Assistive component of the robotic arm was adjusted in accordance with motor level of each patient. Variety and difficulty of games were chosen according to the ability and functional status of the patients. Variety and difficulty level of the games were modified according to progress of patients by the same physiotherapist.
15953251|NCT03239288|Other|Control digestible carbohydrate|Single serving of control product
15953252|NCT03239288|Other|Test resistant starch type 4|Single serving of test product
15953253|NCT03239275|Procedure|Biocreative therapy|
15953254|NCT03239262|Procedure|Concomitant Mapping and Radiofrequency Ablation|"Mapping of GP around the orifice of pulmonary veins was performed, together with their radiofrequency ablation. In the area of right-side pulmonary veins, the procedure was performed prior to initiation of extracorporeal circulation. In case of the left-side PVs; the procedure was performed after initiation of extracorporeal circulation. Part of this procedure was also a decision and ablation of the ligament of Marshall.
~GP mapping was performed using high-frequency stimulation (1000 beats min-¹, potential 18V, pulse width 1.5ms). The indication for GP ablation was a doubling in the R-R interval in the sinus rhythm, or ventricular rate slowing of more that 50% associated with a decrease of blood pressure>20mmHg in patients with AF. In case of a positive response, radiofrequency ablation of the ganglia was performed following switching of the pen at the console. This procedure was repeated until the activity of the ganglia has disappeared."
15953255|NCT03239262|Procedure|No intervention|No intervention was performed in patients without ganglionated plexi.
15953256|NCT03239249|Other|IKO-model|A systematic model for drop-out prevention.
15953257|NCT03239249|Other|Treatment as usual|Schools randomized to control group (22) work as previously with school dropout
15953258|NCT03239236|Procedure|Rapid sequence induction t-RSI|Preoxygenation via face mask, no ventilation with no PEEP until intubation
15953259|NCT03239236|Procedure|Rapid sequence induction m-RSI-PEEP|Preoxygenation via facemask with PEEP of 10 mbar. PEEP will be continued until intubation.
15953260|NCT03239236|Procedure|Rapid sequence induction m-RSI-vent|Preoxygenation via facemask with 10 mbar PEEP and 8 mbar pressure support. Backup frequency set at 10/min. Ventilation via anesthetic machine until intubation.
15953261|NCT03239236|Procedure|m-RSI-vent-cric|Preoxygenation via facemask with 10 mbar PEEP and 8 mbar pressure support. Backup frequency set at 10/min. Ventilation via anesthetic machine until intubation.
15953262|NCT03239236|Procedure|Cricoid Pressure|Cricoid Pressure will be applied during RSI until laryngoscopy
15953263|NCT03239236|Drug|Anesthetics|Induction agents will be administered as quick boluses (Propofol 2,5mg/kg total body weight, max 350mg, Fentanyl 250mcg, Rocuronium 1,2mg/kg ideal body weight).
15953264|NCT03239236|Diagnostic Test|Aspiration of gastric air via nasogastric tube|A nasogastric tube will be inserted at the beginning of laparoscopy and the air from the stomach will be aspirated with a syringe. The amount of air will be measured in ml.
15953265|NCT03239236|Diagnostic Test|Impression of gastric inflation at laparoscopy.|The impression of gastric inflation at laparoscopy. At the beginning of laparoscopy, images of the stomach will be recorded.
15953266|NCT03239236|Diagnostic Test|Arterial blood gas|Arterial blood gases will we drawn at different time points to investigate oxygenation during the procedure. Blood gases will be taken before pre-oxygenation, before anesthesia induction, before laryngoscopy, immediately after intubation when the cuff of the tracheal tube is inflated.
15953267|NCT03239223|Drug|ABI-1968|Topical ABI-1968 Cream or Placebo with 4 doses administered up to 4 Cohorts
15953268|NCT03239210|Drug|Ondansetron|5-HT3 (serotonin receptor type 3) antagonist commonly used to treat nausea and vomiting
15953269|NCT03239210|Drug|Placebo|placebo equivalent
15953270|NCT03239184|Device|Cancer ablation|Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound
15953271|NCT03239184|Drug|Life information rehabilitation therapy|Each treatment: one bottle solution each day, consecutive 3 months, oral administration
15953272|NCT03239171|Device|Cancer ablation|Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound.
15953273|NCT03239171|Drug|Life information rehabilitation therapy|Each treatment: one bottle solution each day, consecutive 3 months, oral administration
15953274|NCT03239158|Device|Cancer ablation|Tumors bigger than 2 cm are fit for ablation therapy, percutaneously under CT scan or ultrasound.
15953275|NCT03239158|Drug|Life information rehabilitation therapy|Each treatment: one bottle solution each day, consecutive 3 months, oral administration
15953276|NCT03239145|Drug|Pembrolizumab|Pembrolizumab is designed to augment the natural ability of the immune system to recognize and target cancer cells
15953277|NCT03239145|Drug|Trebananib|AMG386 is a drug that may kill tumor cells and blocks blood vessels that supply the tumor with nutrients and oxygen
15953278|NCT03239132|Behavioral|Breath-based meditation|The experimental group will receive 4 group sessions of breath-based meditation over 4 weeks.
15953279|NCT03239132|Behavioral|Meditation educational materials|Meditation educational materials
15953280|NCT03239119|Biological|rE-4 5 mcg|Placebo Lead In (5 mcg) for 4 weeks / rE-4 5 mcg for 4 weeks / rE-4 5 mcg for 26 weeks - All are subcutaneously injected twice daily
15953281|NCT03239119|Biological|rE-4 10 mcg|Placebo Lead In (5 mcg) for 4 weeks / rE-4 5 mcg for 4 weeks / rE-4 10 mcg for 26 weeks - All are subcutaneously injected twice daily
15953282|NCT03239119|Biological|Placebo 5 mcg|Placebo Lead In (5 mcg) for 4 weeks / Placebo 5 mcg for 4 weeks / Placebo 5 mcg for 26 weeks - All are subcutaneously injected twice daily
15953283|NCT03239119|Biological|Placebo 10 mcg|Placebo Lead In (5 mcg) for 4 weeks / Placebo 5 mcg for 4 weeks / Placebo 10 mcg for 26 weeks - All are subcutaneously injected twice daily
15953284|NCT03239106|Drug|Apremilast|Apremilast 30 mg BID daily
15953285|NCT03239093|Other|No intervention|Observational study using official data from the Federal Office of Statistics
15953286|NCT03239080|Drug|Denosumab|Subcutaneous injections of denosumab 60mg will be given in 4 doses at each visit (at baseline, 6, 12 and 18 months).
15953287|NCT03239080|Other|Placebo|Subcutaneous injections of placebo (0.9% Sodium Chloride solution) will be given in 4 doses at each visit (at baseline, 6, 12 and 18 months).
15953292|NCT03239015|Drug|Gefitinib|Gefitinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.
15953293|NCT03239015|Drug|Erlotinib|Erlotinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.
15953294|NCT03239015|Drug|Afatinib|Afatinib is an FDA/CFDA approved targeted drugs used for EGFR mutation based on NGS results.
15953295|NCT03239015|Drug|Trastuzumab|Trastuzumab is an FDA/CFDA approved targeted drugs used for Her2 amplification based on NGS results.
15953296|NCT03239015|Drug|Oxazolidine|Oxazolidine is an FDA/CFDA approved targeted drugs used for ALK or ROS-1 or MET fusion based on NGS results.
15953297|NCT03239015|Drug|Olaparib|Olaparib is an FDA/CFDA approved targeted drugs used for BRCA1/2 mutation based on NGS results.
15953298|NCT03239015|Drug|Everolimus|Everolimus is an FDA/CFDA approved targeted drugs used for mTOR or PI3KCA mutation based on NGS results.
15953299|NCT03239015|Drug|Cabozantinib|Cabozantinib is an FDA/CFDA approved targeted drugs used for RET mutation based on NGS results.
15953300|NCT03239015|Drug|Vemurafenib|Vemurafenib is an FDA/CFDA approved targeted drugs used for BRAF mutation based on NGS results.
15953301|NCT03239015|Drug|Dabrafenib|Dabrafenib is an FDA/CFDA approved targeted drugs used for BRAF mutation based on NGS results.
15953302|NCT03239015|Drug|Palbociclib|Palbociclib is an FDA/CFDA approved targeted drugs used for CDK4/6 mutation or amplification based on NGS results.
15953303|NCT03238989|Other|monitoring changes in clinical symptoms, pulmonary function, and chest radiography|For patients with interstitial lung disease, the investigators regularly monitor changes in clinical symptoms, pulmonary function, and chest radiography after basic questionnaire on symptoms, lifestyle, depression, and quality of life.
15953304|NCT03238976|Other|Nature sounds|Nature sounds will be played for patients in the nature sounds exposure group.
15953305|NCT03238963|Drug|BI 1467335|Once daily
15953306|NCT03238963|Drug|Placebo|Once daily
15953307|NCT03238950|Other|Porcine model|participants to conduct training on porcine model
15953308|NCT03238950|Other|Synthetic model|participants to conduct training on synthetic model
15953309|NCT03238937|Device|Phrenic nerve stimulator|Implantation of phrenic nerve stimulator
15953310|NCT03238924|Drug|Oxytocin|40 IU oxytocin nasal spray, self-administered
15953311|NCT03238924|Drug|Placebos|Saline nasal spray, self-administered
15953312|NCT03238911|Drug|Iron isomaltoside/ferric derisomaltose|"Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.
~The dose of iron isomaltoside/ferric derisomaltose for the individual subject was a single IV infusion of 1000 mg (10 mL containing 1000 mg iron isomaltoside/ferric derisomaltose diluted in 100 mL 0.9 % sodium chloride), given over approximately 20 minutes (50 mg iron/min) at baseline (cumulative dose: 1000 mg)."
15953313|NCT03238911|Drug|Ferric carboxymaltose|"Ferric carboxymaltose (Injectafer®; 50 mg/mL) was the comparator in this trial.
~Ferric carboxymaltose was administered as 750 mg, infused over at least 15 minutes at baseline and on day 7 (cumulative dose: 1500 mg)."
15953314|NCT03238898|Drug|Botulinum toxin type A|"botulinum toxin type A injections
~Botulinum toxin type A (100 or 30 units) was injected for each side into the gastrocnemious or the small flexor foot muscles, respectively, according to the predominance of leg or foot cramps."
15953315|NCT03238898|Other|Normal saline|"Normal saline injections
~The same dosage as the active group, but with normal saline alone were injected into the gastrocnemious or the small flexor foot muscles, respectively, according to the predominance of leg or foot cramps."
15953316|NCT03238885|Diagnostic Test|pelvic MR examination|All patients will take pelvic MR examination within 1 week before CRT and within 1 week before surgery.Pre- and post-CRT MRI examinations will be performed using a 3.0 T unit (Discovery 750) using an 8-channel phased array body coil in the supine position. To reduce colonic motility, 20mg of scopolamine butylbromide will be injected intramuscularly 30 min before MRI.
15953317|NCT03238872|Behavioral|Cognitive Behavioural Therapy|
15953318|NCT03238872|Other|Treatment as usual|
15953319|NCT03238859|Device|Real cTBS|This will be delivered with the Magventure Magpro system; 3600 pulses with the active sham coil (double blinded using the USB key)
15953320|NCT03238859|Device|Sham cTBS|This will be delivered with the sham Magventure Magpro system; 3600 pulses with the active sham coil (double blinded using the USB key)
15953321|NCT03238846|Other|Three month dispensing of ART in CARGs|Patients enrolled in the three-month ART dispensing arm will receive a 90-day supply of ART in CARGs from their provider for the duration of the study. Each CARG will consist of 6-12 stable patients on ART and will meet in the community and select a group member to collect their ART at the facility every 3 months. Patients can have unscheduled clinic visits when unwell. Viral loads for the group will be collected at 12 and 24 months at the facility.
15953322|NCT03238846|Other|Six month dispensing of ART in CARGs|Patients enrolled in the three-month ART dispensing arm will receive a 90-day supply of ART in CARGs from their provider for the duration of the study. Each CARG will consist of 6-12 stable patients on ART and will meet in the community and select a group member to collect their ART at the facility every 6 months. Patients can have unscheduled clinic visits when unwell. Viral loads for the group will be collected at 12 and 24 months at the facility.
15953323|NCT03238833|Other|luteal ovarian stimulation|In the in vitro fertilization cycle, controlled ovarian stimulation was started since the luteal phase.
15953324|NCT03238833|Other|follicular ovarian stimulation|In the in vitro fertilization cycle, controlled ovarian stimulation was started since the follicular phase.
15953325|NCT03238820|Procedure|Robotic gastric gastrointestinal stromal tumors resection|Robotic gastric gastrointestinal stromal tumors resection
15953326|NCT03238807|Drug|Human Chorionic Gonadotropin|500 IU of human Chorionic Gonadotropin
15953327|NCT03238794|Procedure|Roux-En-Y Gastric Bypass|Food will be consumed as directed by their doctor as standard of care. A food log will be completed the week before visits 3 and 5.
15953328|NCT03238794|Other|Low-calorie Diet|Food will be consumed as Week one will be liquid 400 to 500 kcal/day, weeks 2,3, and 4 will consist of 500-600 kcal/day of pureed food, weeks 5-8 will consist of 600-800 kcal/day of mechanical-soft food, weeks 9-12 will consist of 800 to 1000 kcal/day of soft foods, and the remainder of the study participants will be given 1000 to 1200 kcal/day of regular food.
15953329|NCT03238781|Drug|Placebo|Placebo was presented in identical containers, stored/packaged the same as AMG 301. All injections were administered within 30 minutes on treatment days.
15953471|NCT03237806|Drug|Deep sedated|Midazolam intravenous continusly infusion, Deep sedated (Ramsay 5)
15953330|NCT03238781|Drug|AMG 301|AMG 301 was packaged in 5 mL clear glass vials containing 1 mL of 70 mg/mL of AMG 301. All injections were administered within 30 minutes on treatment days.
15953331|NCT03238768|Other|Enhanced Intravenous Nutrition|Increased macronutrients for first 7 days
15953332|NCT03238768|Other|Standard Intravenous Nutrition|Standard macronutrients for first 7 days
15953333|NCT03238755|Other|Cardiac MRI/MRS|whole blood, plasma, and serum
15953334|NCT03238742|Drug|Xuebijing Injection|100ml Xuebijing Injection every 12 hours for 5 days
15953335|NCT03238742|Drug|normal saline|200ml normal saline every 12 hours for 5 days
15953336|NCT03238729|Behavioral|Heart Failure Education and Management App|Patients will be provided with an app on a smartphone that provides a daily checklist with items like reminders for logging weight and food, as well as educational components about heart failure and it's management.
15953337|NCT03238729|Behavioral|Heart Failure Literature|Patients will be provided standard literature about heart failure and the management of heart failure.
15953338|NCT03238716|Other|Electric DN|Dry needling with electric stimulation to the erector spine and paraspinal muscles in the lumbar / sacral region and tibialis anterior / posterior. Dry needling with electric stimulation of peri-neural tissue associated with lumbar / sacral nerve roots, pudendal nerve and posterior tibial nerve. 8-12 treatment sessions over 6 weeks.
15953339|NCT03238716|Other|NM Re-ed|"sEMG targeting type I slow-twitch fibers and type II fast-twitch fibers. Type I fibers maintain continuous muscle activity over prolonged periods of time; therefore, training of type I fibers will be achieved through endurance and repetition training of the pelvic floor muscles. Type II fibers are recruited during sudden increases in intra-abdominal pressure, and these fibers will be recruited with The Knack training. The Knack is a term created to use rhythm or timing to the pelvic floor. Neuromuscular re-education will be performed during the first treatment, but it will be performed as needed on subsequent treatments."
15953340|NCT03238716|Other|Exercise|Impairment-specific strength training, which may include transversus abdominis (TrA), gluteus maximus/medius/minimus and/or hip abductor/adductor muscle training. Treadmill, riding the recumbent bike at > 2 METs and/or stair climbing. Exercise training will be performed 7-11 treatment sessions over 6 weeks (following treatment 1).
15953341|NCT03238703|Drug|Anastrozole|Given PO
15953342|NCT03238703|Drug|Exemestane|Given PO
15953343|NCT03238703|Other|Laboratory Biomarker Analysis|Correlative studies
15953344|NCT03238703|Drug|Letrozole|Given PO
15953345|NCT03238703|Other|Quality-of-Life Assessment|Ancillary studies
15953346|NCT03238703|Other|Questionnaire Administration|Ancillary studies
15953347|NCT03238703|Drug|Tamoxifen Citrate|Given PO
15953348|NCT03238703|Drug|Toremifene Citrate|Given PO
15953349|NCT03238690|Device|Controlled Cardiac Reloading through LVAD Speed Adjustment|LVAD speed is reduced at a fixed rate according to the particular LVAD device model implanted. LVAD speed reduction adjustments will be performed at visits occurring every 2 - 3 weeks, up to a total of 8 visits. Reduction of LVAD speed will continue until the soonest of: minimum operating setting as recommended in the LVAD Operator's manual is reached; the minimum setting tolerated by the subject is reached; the subject completes 8 visits; or until the subject receives a heart transplant.
15953350|NCT03238677|Behavioral|Speech Motor Chaining without Biofeedback|These procedures target sound sequences (consonant-vowel, consonant-consonant, or vowel-consonant). Sessions begin with Pre-practice to elicit the target sounds, with verbal cueing and shaping strategies. The Practice component then includes chaining that is response-contingent. Participants practice in blocks of 6 consecutive trials beginning at the syllable level. If 5/6 are correct, the participant advances to monosyllabic word practice, then multisyllabic word practice, phrase practice, and sentence practice (with the target syllable embedded within each level of complexity). If fewer than 5/6 trials are correct, a different syllable with the target sound pattern is practiced next. Verbal feedback is faded from 5 of 6 trials at the syllable level to only 3 of 6 trials at the sentence level. For more description, see http://speechproductionlab.syr.edu/Resources%20for%20Researchers.html
15953351|NCT03238677|Behavioral|Biofeedback|Real-time images of the tongue are made available using ultrasound placed beneath the chin. Participants practice speech movements and can be cued to modify their tongue shape or position to achieve clearer speech. Practice structure is similar to the Speech Motor Chaining procedures, but with the addition of a visual reference.
15953352|NCT03238677|Behavioral|Distributed Practice|2 sessions per week for 10 weeks
15953353|NCT03238677|Behavioral|Massed --> Distributed Practice|Week 1: 10 hours of treatment Week 2: 3 hours of treatment Week 3: 3 hours of treatment Week 4: 2 hours of treatment Week 5: 2 hours of treatment
15953354|NCT03238664|Procedure|Biopsy|Undergo biopsy of bladder tumor
15953355|NCT03238664|Device|High-Intensity Focused Ultrasound Ablation|Undergo laparoscopic HIFU
15953356|NCT03238664|Other|Laboratory Biomarker Analysis|Correlative studies
15953357|NCT03238664|Procedure|Radical Cystectomy|Undergo RARC
15953358|NCT03238664|Device|Ultrasonography|Undergo CEUS
15953359|NCT03238651|Drug|TAK-659|TAK-659 Tablets.
15953360|NCT03238638|Drug|Pembrolizumab|Both cohorts will receive pembrolizumab at a flat dose of 200mg every 3 weeks.
15953361|NCT03238638|Drug|epacadostat|Both cohorts will receive epacadostat. Patients in cohort 1 will take 300mg of epacadostat by mouth twice per day. Cohort 2 will take 300mg of epacadostat every 6 weeks.
15953362|NCT03238625|Drug|Lidocaine and sodium bicarbonate|Lidocaine and sodium bicarbonate ratio 3:1
15953363|NCT03238625|Drug|Lidocaine and sodium bicarbonate|Lidocaine and sodium bicarbonate ratio 9:1
15953364|NCT03238625|Drug|Lidocaine|Lidocaine injection
15953365|NCT03238625|Drug|Sodium cloride 0.9%|Placebo
15953366|NCT03238612|Drug|FFA, clarithromycin, oseltamivir|2-day course of triple combination of clarithromycin 500mg, flufenamic acid 200mg and oseltamivir 75mg twice daily followed by oseltamivir 75mg twice daily for 3 days
15953367|NCT03238612|Drug|Oseltamivir alone|2-day course of oseltamivir 75mg plus placebo capsules twice daily followed by oseltamivir 75mg twice daily for 3 days as control
15953368|NCT03238599|Behavioral|Pedometer-based activity monitoring after ASCT|Measurement of physical daily activity using a digital step counter (Pedometer-based activity monitoring) and assessment of patient well-being using a web-based patient reported tool.
15953369|NCT03238586|Behavioral|WELL Program|
15953370|NCT03238560|Drug|Montelukast Chewable Tablet|Montelukast treatment was used at a dosage of 5mg/day once daily
15953371|NCT03238547|Diagnostic Test|semi-quantitative urine albumin-to-creatinine ratio test|measurement of urine albumin-to-creatinine ratio using URiSCAN 2ACR, a semi-quantitative urine albumin-to-creatinine ratio test
15953372|NCT03238547|Diagnostic Test|standard quantitative spot urine albumin-to-creatinine ratio|measurement of urine albumin-to-creatinine ratio using a standard turbidimetric immunoassay
15953373|NCT03238534|Device|Neobianacid®|Oral administrations of Neobianacid® (30' after meals and on demand)
15953374|NCT03238534|Drug|Omeprazole 20mg|Daily administration Omeprazole 20mg (per os, 30' before breakfast).
15953375|NCT03238534|Other|Neobianacid® placebo|Oral administrations of Neobianacid® placebo (30' after meals and on demand)
15953376|NCT03238534|Other|Omeprazole placebo|Daily administration Omeprazole placebo (per os, 30' before breakfast).
15953377|NCT03238521|Procedure|Spinal osteosynthesis with classical pedicle finder|Posterior thoracic and lumbar osteosynthesis with classical pedicle finder
15953378|NCT03238521|Procedure|Spinal osteosynthesis with pedicle finder with impedancemetry|Posterior thoracic and lumbar osteosynthesis with pedicle finder with impedancemetry
15953379|NCT03238508|Procedure|Deferred stenting|Previously described
15953380|NCT03238495|Drug|Taxotere, Carboplatin, Herceptin + Pertuzumab|TCH+P chemotherapy every 3 weeks for 6 cycles: Taxotere 75mg/m2, Carboplatin AUC 6, Herceptin 6mg/kg (first cycle loading dose of 8mg/kg), Pertuzumab 420mg (first cycle loading does of 840mg)
15953381|NCT03238495|Drug|Metformin|TCH+P chemotherapy every 3 weeks for 6 cycles. Metformin 850 mg daily during the first cycle, then 850 mg twice daily for the remaining 5 cycles.
15953382|NCT03238482|Drug|salmeterol-fluticasone|Seretide Diskus 50/250 µg/dose
15953383|NCT03238482|Drug|salmeterol-fluticasone|Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product E
15953384|NCT03238482|Drug|salmeterol-fluticasone|Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product F
15953385|NCT03238482|Drug|salmeterol-fluticasone|Salmeterol/fluticasone Easyhaler 50/250 µg/dose, product G
15953386|NCT03238469|Device|Microwave ablation|A one-sided (either right or left axillary area) single MWA treatment using a miraDry system. The miraDry device has a microwave output frequency of 5.8 GHz and microwave energy level settings ranging from 1 to 5, corresponding with a delivery time in seconds between 2.40 sec and 3.00 sec. For this study standard 5 (i.e. 3.00 sec) is set as treatment setting.
15953387|NCT03238456|Behavioral|Motivating Pacifika Against Cigarettes and Tobacco|"Participants received one encouraging text message per day prior to their quit date. During the intervention, they received daily text messages with decreasing frequency per week. Participants were also able to craft personal text messages. On-demand text messages were optional and could be requested by texting key words to the program hotline.
~The online MPACT program allowed participants to access eight educational modules and a forum where they could communicate with other participants. The modules focused on different aspects of quitting smoking, such as how to deal with withdrawal symptoms, triggers of tobacco use, and stress. Participants were limited to one module per day in order to increase the duration of exposure to the program. Upon completion, participants no longer received text messages but they were still able to access the educational modules, forum, and on-demand text messages."
15953388|NCT03238430|Drug|intrathecal morphine|A single intrathecal injection of 300 micrograms of Morphine preoperatively, just before induction.
15953389|NCT03238430|Drug|Morphine PCA|a postoperative Morphine PCA
15953390|NCT03238430|Drug|Ropivacaine infiltration|Ropivacaine 2mg / ml at the rate of 8ml per hour via a multiperforated catheter with connector after bolus of 20 ml
15953391|NCT03238417|Other|Evidence-Based Quality Improvement|Multilevel research-clinical partnership approach to supporting local strategic planning, priority setting, skill building and engagement in addressing targeted healthcare delivery problems. Launched at participating VA facilities through advance key stakeholder interviews, in-person site visits, data review (e.g., structure and environment of care, gender disparities in quality and patient experience), QI education/training, technical support (e.g., QI project and measures development), additional formative feedback from the evaluation (e.g., provider/survey measure summaries), external and internal practice facilitation, and across-EBQI site collaboration calls. Local leadership, EBQI champions and QI teams develop and implement innovation projects aimed at improving prioritized quality targets related to women Veterans' health and healthcare needs as well as facility-level structural changes needed to improve compliance with VA guidelines.
15953392|NCT03238404|Procedure|NAC group|NAC is the name of a procedure. NAC doesn't mean different interventions are used. Patients in this group need receive this NAC procedure instead of one drug before the gastrectomy and ERAS. The program consists of an intravenous injection of 130 mg/m2 oxaliplatin on day 1, followed by oral administration of 50 mg tegafur gimerac (the name of an anticarcinogen) twice daily on days 1-14, every 3 weeks.
15953393|NCT03238404|Procedure|Surgery alone group|Patients will not receive neoadjuvant chemotherapy and they will undergo the gastrectomy and ERAS alone.
15953394|NCT03238391|Procedure|Ischemic preconditioning|It is mentioned before in arm/group descriptions
15953395|NCT03238378|Radiation|Brachytherapy|Brachytherapy d 1-5(6)
15953396|NCT03238378|Other|Hyperthermia|Hyperthermia d 2 + 5
15953397|NCT03238365|Biological|Nivolumab|Given IV
15953398|NCT03238365|Drug|Tadalafil|Given orally
15953399|NCT03238365|Procedure|Therapeutic Conventional Surgery|Undergo surgery
15953400|NCT03238352|Device|Potassium oxalate|Oral rinse containing 1.5 percent (%) KOX and 0 ppm fluoride
15953401|NCT03238352|Drug|Sodium fluoride|Oral rinse containing 0.02% weight by weight (w/w) sodium fluoride (NaF)
15953402|NCT03238352|Other|Placebo|Oral rinse containing 0% KOX and 0 ppm fluoride
15953404|NCT03238313|Behavioral|Plan A|
15953405|NCT03238313|Behavioral|Toxic Life Cycle of a Cigarette|Video
15953406|NCT03238300|Drug|N-Acetylcysteine|N-Acetylcysteine pill.
15953407|NCT03238300|Drug|Placebo Oral Capsule|Sugar pill to mimic.
15953408|NCT03238287|Device|Mechanical chest compression|In the application of advanced cardiac life support, chest compression is done with mechanical chest compression device. rSO2 measurements are used to detect the impact of the compression on brain perfusion. The application is performed in accordance with the recommendations on advanced cardiac life support in the current guidelines.
15953409|NCT03238287|Other|Manuel chest compression|In the application of advanced cardiac life support, chest compression is done with hands. rSO2 measurements are used to detect the impact of the compression on brain perfusion. The application is performed in accordance with the recommendations on advanced cardiac life support in the current guidelines
15953410|NCT03238274|Device|Sofia 2 Lyme FIA testing|IVD testing of whole blood or serum/plasma to aid in the detection of anti-B. burgdorferi IgG / IgM antibody
15953411|NCT03238261|Radiation|Chemotherapy and concomitant radiotherapy|Radiotherapy (teletherapy + high or low rate brachytherapy)
15953412|NCT03238248|Drug|Azacitidine Subcutaneous Injection or Intravenous Infusion|75 mg/m2
15953413|NCT03238248|Drug|Pevonedistat Infusion|20 mg/m2
15953414|NCT03238248|Procedure|Bone Marrow Biopsy & Aspirate|Removal of a small piece of bone and bone marrow by inserting a needle into hip bone.
15953415|NCT03238235|Drug|givinostat|suspension of givinostat (10 mg/mL)
15953416|NCT03238235|Drug|placebo|suspension manufactured to mimic givinostat
15953417|NCT03238222|Behavioral|MOSAIC|MOSAIC comprises 2 x 60-minute individual face-to-face consultations (weeks 1 & 2) and 2 x 20-minute follow-up telephone calls (weeks 6 & 12) delivered at a convenient time and location of participant's choice (local NHS Trust or participant's home). All sessions are delivered by a trained Band 6/7 physiotherapist. All participants randomized to receive MOSAIC will be provided with a pedometer and a patient manual which will include information on intermittent claudication, risk factors, walking guidelines, goal setting, problem solving and action planning worksheets and a walking diary.
15953418|NCT03238209|Diagnostic Test|Exercise testing|The test consisted of a steady-state resting period of 3 min followed by 1 min of unloaded pedaling at 60 cycles/min for each individual; the exercise load was increased by 10 W each min until the test had to be stopped because symptoms prevented further exercise. After test results were recorded, EMGdi,es and each surface inspiratory EMG of maximal exercise capacity were analysed.
15953419|NCT03238196|Drug|Erdafitinib|4mg - 8mg
15953420|NCT03238196|Drug|Palbociclib|125 mg
15953421|NCT03238196|Drug|Fulvestrant|500 mg
15953422|NCT03238183|Drug|dextrose|compare the therapeutic effects of hyaluronic acid combined dextrose injections with hyaluronic acid injections only to patients with knee osteoarthritis
15953423|NCT03238183|Device|hyaluronic acid|compare the therapeutic effects of hyaluronic acid combined dextrose injections with hyaluronic acid injections only to patients with knee osteoarthritis
15953424|NCT03238170|Device|MRI scan|MRI scan using the Siemens Aera® (Siemens AG Healthcare, Erlangen, Germany) on the same day as their treatment planning CT scan
15953425|NCT03238157|Drug|Fluocinolone Acetonide (FA) implant|Fluocinolone Acetonide (FA) implant is designed to release FA at an initial rate of approximately 0.6 g/d, decreasing over the first month to a steady rate of 0.3 to 0.4 g/d with a duration of approximately 30 months.
15953426|NCT03238144|Other|MRF scan|MRF with or without dynamic contrast-enhanced MRI scans.
15953427|NCT03238131|Drug|Ivermectin|Participants are either given Ivermectin alone or Ivermectin in combination with Albendazole
15953428|NCT03238131|Drug|Albendazole|Albendazole will be given to participants in Arm 2 and 3 in combination with Ivermectin at varying time points.
15953429|NCT03238118|Other|Attention bias modification training|"Participants will complete the assigned attention-training task three times a week for two weeks (six sessions), yielding 960 trials. Each session consists of three parts: evaluating the individual baseline, training and testing. Participants will also be required to complete a self-report assessment before and after each session. Participants will be evaluated at baseline, the end of week 1 and at the end of week 2 by blind investigators.
~Psychoeducation Participants will receive psychoeducation once a week for two weeks. Participants will also be required to complete a self-report assessment before and after each session of psychoeducation. Participants will be evaluated at baseline, the end of week 1 and at the end of week 2 by blind investigators."
15953430|NCT03238118|Other|Attention Control Training|"Attention Control Training Participants will complete the assigned attention-training task three times a week for two weeks (six sessions), yielding 960 trials. Each session consists of three parts: evaluating the individual baseline, training and testing. Participants will also be required to complete a self-report assessment before and after each session. Participants will be evaluated at baseline, the end of week 1 and at the end of week 2 by blind investigators.
~Psychoeducation Participants will receive psychoeducation once a week for two weeks. Participants will also be required to complete a self-report assessment before and after each session of psychoeducation. Participants will be evaluated at baseline, the end of week 1 and at the end of week 2 by blind investigators."
15953431|NCT03238118|Other|Psychoeducation|Participants will receive psychoeducation once a week for two weeks. Participants will also be required to complete a self-report assessment before and after each session of psychoeducation. Participants will be evaluated at baseline, the end of week 1 and at the end of week 2.
15953432|NCT03238105|Drug|Thioglycolic Acid|Monthly sessions for 3 months with progressive increase of the duration of contact time of the drug with the skin, 3, 6 and 9 minutes.
15953433|NCT03238105|Device|Intense Pulsed Light|Monthly sessions for 3 months.
15953434|NCT03238092|Drug|Testosterone|testosterone gel daily during the late luteal phase.
15953435|NCT03238092|Drug|Estradiol|oral estradiol during the late luteal phase.
15953436|NCT03238079|Biological|10% IGIV|300-900 mg/kg
15953437|NCT03238066|Radiation|Brachytherapy|HDR/PDR brachytherapy
15953438|NCT03238066|Other|Hyperthermia|Interstitial hyperthermia
15953439|NCT03238053|Procedure|Vaginal laser treatment|Fractional CO 2 laser system (SmartXide 2 V 2 LR,DEKA, Florence, Italy), using the following setting: dot power 30 watt, dwell time 1000 μ s, dot spacing 1000 μ m and the smart stack parameter from 1 to 3. The laser beam is provided using a vaginal probe, which is gently inserted up to the top of the vaginal canal and subsequently withdrawn and rotated in order to provide a complete treatment of the vaginal wall. At the level of the vaginal introitus, the dot power is decreased to 20 watt 27 . A treatment cycle includes three laser applications (every 4 weeks). The procedure is performed in the outpatient clinic and does not require any specific preparation (e.g. analgesia/anesthesia).
15953472|NCT03237806|Drug|Light sedated|Midazolam intravenous continusly infusion, Light sedated (Ramsay 3)
15953508|NCT03237546|Procedure|Anesthetic regimen including SB or no block|Group receiving general anesthesia alone
15953509|NCT03237533|Drug|Dexamethasone|Dexamethasone will be applied locally on the lesion
15953440|NCT03238053|Device|sham|Fractional CO 2 laser system (SmartXide 2 V 2 LR,DEKA, Florence, Italy), using the following setting: dot power 30 watt, dwell time 1000 μ s, dot spacing 1000 μ m and the smart stack parameter from 1 to 3. The laser beam is provided using a vaginal probe, which is gently inserted up to the top of the vaginal canal and subsequently withdrawn and rotated in order to provide a complete treatment of the vaginal wall. At the level of the vaginal introitus, the dot power is decreased to 20 watt 27 . A treatment cycle includes three laser applications (every 4 weeks). The procedure is performed in the outpatient clinic and does not require any specific preparation (e.g. analgesia/anesthesia).
15953441|NCT03238053|Device|laser system|FractionalCO 2 laser system (SmartXide 2 V 2 LR,DEKA, Florence, Italy), using the following setting: dot power 30 watt, dwell time 1000 μ s, dot spacing 1000 μ m and the smart stack parameter from 1 to 3. The laser beam is provided using a vaginal probe, which is gently inserted up to the top of the vaginal canal and subsequently withdrawn and rotated in order to provide a complete treatment of the vaginal wall. At the level of the vaginal introitus, the dot power is decreased to 20 watt 27 . A treatment cycle includes three laser applications (every 4 weeks). The procedure is performed in the outpatient clinic and does not require any specific preparation (e.g. analgesia/anesthesia).
15953442|NCT03238040|Other|None, observational study|Observational study, no interventions
15953443|NCT03238027|Drug|SNDX-6352|Humanized IgG4 mAb that blocks colony stimulating factor 1 receptor (CSF-1R)
15953444|NCT03238027|Drug|Durvalumab|Durvalumab (MEDI4736) is a humanized IgG1 kappa mAb that blocks the interaction of PD-L1 with PD-1 CD80 (B7.1) molecules
15953445|NCT03238014|Device|Noninvasive positive pressure ventilation|Noninvasive positive pressure ventilation used assist/control mode treat severe stable chronic obstructive pulmonary disease.
15953446|NCT03238001|Device|DCTclock|DCTclock is a quick and non-invasive test that measures cognitive function based on a computerized algorithmic analysis of the entire drawing process and output of a well-established cognitive assessment called The Clock Drawing Test (CDT).
15953447|NCT03237988|Drug|CPI-444 Capsules|100mg Capsule
15953448|NCT03237988|Drug|CPI-444 Tablets|100mg Tablets
15953449|NCT03237975|Behavioral|Be the Expert for Your Own (BEYO)|"The BEYO program is structured adopting solution focused therapy (SFT). The basic principles for SFT are focusing on positive change and establishing groups driven by goals rather than problems. Solutions are generated through searching for strengths, skills, resources that working in clients' lives.
~The common flow for structured sessions contains 7 steps: 1) Health education; 2) Discuss self-care experience and identify deficit; 3) Describe exceptions; 4) Identify the strengths; 5) Miracle question and scaling; 6) Establish the solution; 7) Action plan."
15953450|NCT03237975|Other|Routine health education|The control group will receive routine health education.
15953451|NCT03237962|Device|High Flow Nasal Cannula|High Flow Nasal Cannula (HFNC) is an oxygen device that increases oxygenation and washes out CO2 within the dead space, it was also clinically used to correct hypoxemia, hypercapnia and respiratory failure.By providing flow rate that is similar to or higher than the patient's inspiratory flow, HFNC is able to provide ventilatory support. To produce stable oxygen concentration, HFNC entrains less air in order to reach the preset value.
15953452|NCT03237962|Device|Nasal Cannula|Nasal cannula is an oxygen therapy device that has been commonly used as treatment for patients with hypoxemia. With the adjustable flow of 1-6Lpm, the concentration of the oxygen differs as the breathing pattern of the patient changes.
15953453|NCT03237949|Behavioral|Phone counseling|Four telephone counseling sessions using a motivational interviewing approach
15953454|NCT03237949|Behavioral|Text message|30 messages (2 per day) and patients unwilling to quit 16 (2 per day). The messages follows the self efficacy theory. The messages follows the self efficacy theory.
15953455|NCT03237936|Drug|1mg/mL ciclosporin|IKERVIS® (1mg/ml ciclosporin) eye drops administered once daily following 3 months of treatment
15953456|NCT03237923|Device|EasySense device|Implementation of EasySense device during hospitalization and daily post-discharge for thirty days.
15953457|NCT03237910|Diagnostic Test|AMSA|A non-invasive and real time VF (Amplitude Spectrum Area) AMSA analysis is performed during chest compression pauses for delivery of 2 ventilations, from the ECG acquired from the conventional defibrillatory pads
15953458|NCT03237910|Procedure|Defibrillation|delivery of the defibrillation is attempted to terminate VF either based on AMSA value (in the AMSA-CPR arm) or every 2-min CPR cycle as recommended by current guidelines (in the Standard-CPR arm)
15953459|NCT03237910|Procedure|CPR|chest compressions and ventilations at a rate of 30:2
15953460|NCT03237897|Behavioral|Preoperative education class|The preoperative enhanced recovery after surgery education class will be offered twice a week in coordination with anesthesia preoperative appointments to minimize inconvenience for patients. Patients will need to attend only one class. All participants will be offered the class. This class will be one hour in duration and will be taught by a surgical advanced care practitioner familiar with the details of colorectal surgery. The class will include detailed information about preoperative care, intraoperative care, and postoperative care.
15953461|NCT03237897|Behavioral|Pedometer|A pedometer will be affixed to patients in the immediate postoperative period and removed at time of discharge
15953462|NCT03237871|Behavioral|Text-message survey and informational text messages|Participants will complete a text-messaged survey each week for 5 weeks assessing economic and sexual risk behaviors. Participants will also receive 3 informational text messages each week for 5 weeks on HIV prevention and economic empowerment.
15953465|NCT03237845|Drug|Rimegepant|75 mg tablet QD
15953466|NCT03237845|Drug|Placebo|Placebo tablet to match rimegepant dose QD
15953467|NCT03237832|Drug|ARN-6039|Ascending doses per Cohort
15953468|NCT03237832|Other|Placebo|Placebo to match ARN-6039
15953473|NCT03237793|Procedure|Fluorosed Group|A single episode of laser therapy with without potassium nitrate (RA Thermoseal*) desensitising agent application was administered to the patients, A group only with desensitising paste and A group with desensitising paste and laser treatment depending on the study group they were assigned
15953474|NCT03237793|Procedure|Non Flourosed Group|A single episode of laser† therapy with or without potassium nitrate (RA Thermoseal*) desensitising agent application was administered to the patients, depending on the study group they were assignedGROUP 2B: Patients with healthy non fluorosed teeth receiving diode laser treatment$. (n=15)GROUP 2C: Patients with healthy non fluorosed teeth receiving diode laser + desensitising agent (potassium nitrate- RA thermoseal**) treatment.
15953478|NCT03237767|Other|MIE|"The moderate intensity exercise (MIE) condition will begin and end with an appropriate warm-up (3 minutes at 20 W) and cool-down (2 minutes at 20 W), respectively. Throughout all exercising procedures, participants will maintain a pedal cadence of 60-80 rpm, with the average being noted and kept consistent between trials. Additionally, verbal encouragement will be given depending on the participant's preference, and kept consistent between visits.
~The MIE bout will be in coherence with the physical activity guidelines for people with CF (150 min/week of moderate to vigorous physical activity). For the MIE, participants will cycle for approximately 30 minutes at 90% of their gas exchange threshold."
15953479|NCT03237767|Other|HIIE|"The high-intensity interval exercise (HIIE) condition will begin and end with an appropriate warm-up (3 minutes at 20 W) and cool-down (2 minutes at 20 W), respectively. Throughout all exercising procedures, participants will maintain a pedal cadence of 60-80 rpm, with the average being noted and kept consistent between trials. Additionally, verbal encouragement will be given depending on the participant's preference, and kept consistent between visits.
~The HIIE will be matched for the projected work done during the MIE. The HIIE protocol has been extrapolated from recent reports which have shown improvements in glycaemic control and vascular endothelial function. Specifically, participants will cycle at 90% of their peak power output for 60 seconds, followed by 60 seconds of active recovery."
15953480|NCT03237754|Device|tDCS device from neuroConn|weak electrical direct current stimulation
15953481|NCT03237741|Drug|Reference capsule GDC-0134|Oral administration of a single dose of 200 milligrams (mg) GDC-0134 reference capsule administered as two 100 mg capsules.
15953482|NCT03237741|Drug|Prototype capsule GDC-0134|Oral administration of a single dose of 200 mg GDC-0134 prototype capsule administered as one 200 mg capsule.
15953483|NCT03237741|Drug|rabeprazole|Oral administration of 20 mg rabeprazole once daily on Days -3, -2 and -1 as well as on Day 1 two hours prior to each administration of GDC-0134 during Period 4.
15953484|NCT03237728|Drug|0.06mg/kg,KB|0.06mg/kg,Q8h,Day1-Day7
15953485|NCT03237728|Drug|0.12mg/kg,KB|0.12mg/kg,Q8h,Day1-Day7
15953486|NCT03237728|Drug|0.24mg/,KB|0.24mg/kg,Q8h,Day1-Day7
15953487|NCT03237728|Drug|Placebos|Placebos,Q8h,Day1-Day7
15953488|NCT03237715|Other|Assessment of unbound bilirubin levels|Collection of residual blood for measurement of unbound bilirubin
15953489|NCT03237702|Dietary Supplement|Multi-Carotenoids|All participants in the second stage will receive multi-carotenoids 30 mg qd for 8 weeks.
15953490|NCT03237689|Drug|Hydrocortisone|Low dose hydrocortisone (10mg)
15953491|NCT03237689|Drug|Placebo Oral Tablet|capsules of starch 1500 powder
15953492|NCT03237676|Other|Structured cognitive rehabilitation therapy|A computer-based cognitive rehabilitation therapy Therapy frequency is one hour session per week for three months.
15953493|NCT03237676|Other|Patient-centred cognitive therapy|"Application of existing cognitive therapy at University Malaya Medical Centre, Malaysia. It is a patient-centred therapy approach over a period of three months, which include therapy session on symptoms management and coping strategies.
~Clinical and treatment review are provided as part of routine outpatient rehabilitation clinic review."
15953494|NCT03237663|Biological|The oral O1 / O139 cholera vaccine (enteric capsules)|
15953495|NCT03237637|Drug|oral propranolol|oral propranolol 1-2mg/kg/day as crushed tablets in two divided doses
15953496|NCT03237637|Drug|oral atenolol|oral atenolol 0.5-1mg/kg/day as crushed tablets in a single dose
15953497|NCT03237624|Device|Functional Chitosan Chewing Gum|Chitosan and chitosan-related preparations have been shown to have some antimicrobial properties, possibly in the disruption of bacterial colonization. It is thought that as a component of a functional chewing gum this will supplement in the removal of daily build up of dental plaque on tooth surfaces.
15953498|NCT03237624|Device|Control Chewing Gum|Control chewing gum device does not have food additive chitosan in its composition.
15953499|NCT03237624|Behavioral|Oral hygiene measures|Patients will be given instructions on how to brush and floss routinely (twice per day)
15953500|NCT03237611|Drug|Aprepitant 125 mg|Patient scheduled for the first cycle of carboplatin-based chemotherapy will be offered to receive low doses of aprepitant (125mg of oral aprepitant) or 115mg of fosaprepitant intravenously for prevention of chemotherapy-induced nausea and vomiting
15953501|NCT03237611|Drug|Fosaprepitant 115 MG|Patient scheduled for the first cycle of carboplatin-based chemotherapy will be offered to receive low doses of aprepitant (125mg of oral aprepitant) or 115mg of fosaprepitant intravenously for prevention of chemotherapy-induced nausea and vomiting
15953502|NCT03237611|Drug|Dexamethasone|Dexamethasone will be given as a part of standard CINV prophylaxis for patients receiving carboplatin-based chemotherapy, dosed at 20mg on day 1 of chemotherapy
15953503|NCT03237611|Drug|Ondansetron 16 MG|Ondansetron will be given as a part of standard CINV prophylaxis for patients receiving carboplatin-based chemotherapy, dosed at 16mg on day 1 of chemotherapy
15953504|NCT03237585|Behavioral|Rural response system (RRS) intervention to reduce violence against women|The Rural Response System which uses the strategy of trained community members known as Community-based action team, COMBAT to undertake awareness-raising on gender-based violence as well as providing support to victims of violence to access justice and other relevant services.
15953505|NCT03237572|Drug|Pembrolizumab|Pembrolizumab (200 mg)
15953506|NCT03237572|Device|High-intensity focused ultrasound (HIFU)|Ablation will target 50% of the tumor, up to 3 cubic centimeters
15953507|NCT03237546|Procedure|Anesthetic regimen including SB|Group receiving general anesthesia with the serratus block
15953510|NCT03237520|Other|Virtual Reality Therapy|VRT software and device is developed in collaboration with IIT Delhi using Kinect system. Kinect- motion sensor and computer set up is required. VRT (CIMT in a virtual environment)will be provided for 2 hours at every visit(twice weekly for first 4 weeks, once a week for next 4 weeks). VRT will be provided only during scheduled visits with the same principle as mCIMT. Functional activities like repetition of the tasks and shaping will be performed with the affected hand using VRT and CIMT while the unaffected arm is restrained
15953511|NCT03237520|Other|mCIMT|Modified constraint induced movement therapy will be provided to all children according to predefined protocol.
15953512|NCT03237507|Drug|S-1|40-60mg/m^2 bid, days 1-14, oral，every 3 weeks.
15953513|NCT03237507|Drug|oxaliplatin|100mg/m^2 days 1，intravenous infusion, every 3 weeks.
15953514|NCT03237507|Device|Hyperthermic Intraperitoneal|hyperthermic intraperitoneal chemoperfusion
15953515|NCT03237507|Drug|Paclitaxel|intraperitoneal perfusion
15953521|NCT03237468|Other|Neck strengthening exercise to prevent concussion|Neck strengthening exercise to prevent concussion in student athletes.
15953522|NCT03237455|Diagnostic Test|Thoracic spine x-rays+whole spine MRI|PA radiographs of the thoracic spine and MRI of the whole spine and sacroiliac joints
15953523|NCT03237455|Diagnostic Test|blood tests|blood chemistry including total cholesterol, LDL HDL, CBC, HbA1C, fasting glucose, TG, and insulin levels, HLA-B27, 2 vials of frozen serum for future studies.
15953524|NCT03237455|Other|constitutional and demographic data collection|demographics, concomitant diseases (in particular type 2 DM, hypertension, hyperlipidemia) concomitant medications, height and weight (BMI), waist circumference
15953525|NCT03237442|Biological|human umbilical cord mesenchymal stem cells|human UC-MSCs: 0.2ml(about 2*10^6 cells) subconjunctival injection
15953526|NCT03237442|Biological|placebo|Saline injection
15953527|NCT03237429|Diagnostic Test|bioimpedance spectroscopy|"Bioimpedance spectroscopy-The technique involves attaching electrodes to the patient's forearm and ipsilateral ankle, with the patient in a supine position. The BCM measures the body resistance and reactance to electrical currents of 50 discrete frequencies, ranging between 5 and 1000 kHz. Based on a fluid model using these resistances, the extracellular water (ECW), the intracellular water (ICW) and the total body water (TBW) are calculated. These volumes are then used to determine the amount of fluid.
~Carotid-femoral pulse wave velocity-will be determined by arterial applanation tonometry using the Sphygmocor system by sequentially recording ECG-gated carotid and femoral artery waveforms.. Pulse wave signals will be recorded by tonometers positioned at the base of the right common carotid artery and over the right femoral artery."
15953528|NCT03237416|Drug|Dabigatran etexilate|In Period 1, Day 1 a single dose of 75 mg will be administered after breakfast In Period 2, Day 3 a single dose of 75 mg will be administered prior to breakfast In Period 2, Day 9 a single dose of 75 mg will be administered after breakfast
15953529|NCT03237416|Drug|Midazolam|In Period 1, Day 1 a single dose of 1 mg will be administered after breakfast In Period 2, Day 9 a single dose of 1 mg will be administered after breakfast
15953530|NCT03237416|Drug|BAY1841788 (darolutamide)|In Period 2, Days 1-11 600 mg twice a day (as 2 x 300 mg tablets) will be administered after breakfast
15953531|NCT03237403|Other|observational study|observational study between clinical criteria collected at SAMU regulation centre call and hospital orientation
15953532|NCT03237390|Drug|Gemcitabine Hydrochloride|Given IV
15953533|NCT03237390|Other|Laboratory Biomarker Analysis|Correlative studies
15953534|NCT03237390|Other|Pharmacological Study|Correlative studies
15953535|NCT03237390|Drug|Ribociclib|Given PO
15953536|NCT03237377|Drug|Durvalumab|1500mg via IV infusion every 4 weeks for up to 3 doses/cycles
15953537|NCT03237377|Drug|Tremelimumab|75mg via IV infusion every 4 weeks
15953538|NCT03237377|Radiation|Thoracic Radiation|5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction
15953539|NCT03237364|Diagnostic Test|Perfluorinated Gas/Oxygen Mixture|19-Fluorine (19F) MRI of the lungs with 21%/79% Oxygen/Perfluorinated Gas, ≤ 25 liters, gas, single visit, < 1 hour
15953540|NCT03237351|Device|Fluid therapy|Conventional therapy group: conventional arterial blood pressure monitoring. Low value of PPV group and high value of PPV group:pulse pressure variation monitoring with arterial blood pressure monitoring.
15953541|NCT03237338|Procedure|ture acupuncture|"ture acupuncture at the Magical-door, Si-shen-cong, Shen-ting, Local-cave acupoints, three times per week and last for 6 weeks"
15953542|NCT03237338|Procedure|sham acupuncture|"Sham acupuncture at the Magical-door, Si-shen-cong, Shen-ting, Local-cave acupoints, three times per week and last for 6 weeks"
15953543|NCT03237325|Drug|SGX942|1.5 mg/mL SGX942 administered as a 4 minute IV infusion, twice per week starting within 3 days after initiating radiation therapy and continuing through 2 weeks after radiation therapy ends.
15953544|NCT03237325|Drug|Placebo|Placebo is 0.9% sodium chloride (normal saline). The treatment preparation, frequency and duration of therapy are identical to that of the active drug.
15953545|NCT03237312|Procedure|Laparoscopic ovarian drilling|The electric current used was set at 40 Watts. The power was activated just before touching the ovary, and then the needle electrode was held against the antimesenteric surface of the ovary for 4 seconds until penetration of the ovarian capsule. Four or eight puncture points were made through the ovarian capsule of each ovary according to the study protocol. The ovaries were cooled in the pool of the Ringer's lactate after each cauterization both to minimize adhesion formation and to prevent heat trauma to the adjacent viscera. Complete hemostasis was ensured. At the end of the procedure, the ovaries were copiously rinsed with Ringer's lactate (Aqua-purator, Storz, Germany). An amount about 200 ml of heparinized Ringers lactate (5000 IU/1000 ml) was left in the pelvis to avoid postoperative adhesions.
15953546|NCT03237312|Biological|Antimullerian hormone|"In patients with Antimullerian hormone between 4-8 ng/ml 4 punctures in each ovary were performed.
~In patients with Antimullerian hormone above 8 ng/ml 8 punctures in each ovary were performed."
15953673|NCT03236246|Drug|KRX-0502|Oral ferric citrate with meals
15987885|NCT02979145|Other|No intervention involved|
15953547|NCT03237299|Other|Collection of data|Collection of data on clinical, bacteriological and computed tomography data concerning the case, which will be needed by the adjudication committee and for defining the index date.
15953548|NCT03237299|Other|No collection of data|The interviewer will note sociodemographic characteristics (age, weight, sex), symptoms and their evolution, and all drug intakes of the patient during the month before the index date.
15953549|NCT03237286|Drug|Intravenous ketamine|Intravenous ketamine is given at a subanesthetic dose, which previous research suggests is safe and efficacious for rapid relief from depression.
15953550|NCT03237286|Behavioral|Computer-based Cognitive Training|"Computer-based Cognitive Training will be delivered following intravenous ketamine to test whether learning during a post-ketamine window of opportunity might extend relief from depression."
15953551|NCT03237273|Other|HEAD-US scoring system|HEAD-US scoring system - Ultrasound scan performed by a non-imaging specialist to assess for joint bleed or damage
15953552|NCT03237260|Drug|Vedolizumab|Initiation: 300 mg at week 0, 2 and 6. Maintenance: Every 8 weeks after the sixth week at a fixed dose of 300 mg
15953553|NCT03237234|Other|Motor Skill Training|Motor skill training will consist of activities that will be performed while standing to promote upright control (the toe-tapping activity will be performed while seated). Participants will perform each of the 6 different activities for one minute each, until 4 cycles of the circuit have been completed (approximately 25 minutes total). Motor training activities will be performed at an intensity of 40-59% of heart rate reserve (HRR). Toe tapping will provide the opportunity for scheduled rest. During MT, all participants will wear a heart rate monitor to ensure that the optimal HR range is achieved. HRR will be calculated from resting and peak heart rate measures obtained during baseline testing via administration of a graded-exercise test.
15953554|NCT03237234|Device|Transcranial direct current stimulation (tDCS)|The tDCS electrode placement is based on procedures shown to improve gait and balance in a single session when used in combination with gait training activities. tDCS electrodes can simultaneously activate the bilateral leg motor areas when placed at the midline of the scalp slightly anterior to the vertex (anode) and at the inion (cathode), with a current intensity of 2mA. The tDCS device is lightweight, and can be worn in a backpack during the MT activities. As reported previously, participants in the MT-only group will receive sham tDCS to maintain analogous study procedures.
15953555|NCT03237221|Drug|Treat patient according to Global Initiative for Asthma (GINA) guideline|Treat patient according to Global Initiative for Asthma (GINA) guideline
15953556|NCT03237208|Device|TENS|Transcutaneous electrical nerve stimulation (TENS) treatment will be activated.
15953557|NCT03237208|Device|placebo group|Transcutaneous electrical nerve stimulation treatment will not be activated.
15953558|NCT03237195|Other|additional soft tissue in neck dissections|Evaluation of submission of additional soft tissue in neck dissections for head and neck squamous cell carcinomas
15953559|NCT03237182|Drug|Individualized TB treatment with multiple drugs|"Patients with drug-resistant TB will receive a combination of any of the following drugs based on whole genome sequencing:
~rifampicin, rifabutin, isoniazid, high dose isoniazid, pyrazinamide, ethambutol, levofloxacin, moxifloxacin, ofloxacin, gatifloxacin, amikacin, capreomycin, kanamycin, streptomycin, ethionamide, prothionamide, cycloserine, terizidone, pretomanid, linezolid, sutezolid, clofazimine, bedaquiline, delaminid, para-aminosalicylic acid, imipenem/cilastatin, meropenem, amoxicillin/clavulanate, clarithromycin, azithromycin and thioacetazone"
15953560|NCT03237182|Drug|Standardized TB treatment with multiple drugs|"Patients with drug-resistant TB with receive a combination of any of the following drugs based on South African Department of Health guidelines:
~rifampicin, rifabutin, isoniazid, high dose isoniazid, pyrazinamide, ethambutol, levofloxacin, moxifloxacin, ofloxacin, gatifloxacin, amikacin, capreomycin, kanamycin, streptomycin, ethionamide, prothionamide, cycloserine, terizidone, pretomanid, linezolid, sutezolid, clofazimine, bedaquiline, delaminid, para-aminosalicylic acid, imipenem/cilastatin, meropenem, amoxicillin/clavulanate, clarithromycin, azithromycin and thioacetazone"
15953561|NCT03237156|Drug|TAK-906|TAK-906 capsules.
15953562|NCT03237156|Drug|TAK-906 Placebo|Placebo capsules.
15953563|NCT03237130|Procedure|preoperative enhanced chest CT examination|Each patient will receive preoperative enhanced chest CT examination, and their CT images will be used for analysis
15953564|NCT03237117|Biological|Growth Hormone (GH)|to evaluate the effect of GH administration in the donated oocyte recipient program among women with RIF (repeated implantation failure)
15953565|NCT03237104|Other|Immediate PT|Athletes will perform phase I (neutral spine) of the program and progress to phase II (functional motion) as able without an increase in pain and without compensations noted in function. The athlete will be assessed at each session to determine if they meet the criteria to begin the next step of functional progression program. Once the athlete has met the criteria of phase II, they will progress into the final phase of the functional progression program for return to sport activity. As these athletes progress through the third phase, and are able to meet the return to sport criteria, they will be released to return to sport. Athletes will not be released to return to sport prior to their first physician follow-up visit at 4 weeks.
15953566|NCT03237091|Other|bihemispheric transcranial pulsed current stimulation (tPCS)|Two sets of sponge electrodes (one set placed on each side of the head) will be placed on the participant's head. The transcranial electrical stimulator will apply unidirectional, positive pulses of current separated by brief interpulse intervals to the scalp via the sponges for 30 minutes.
15953567|NCT03237091|Other|unihemispheric transcranial pulsed current stimulation (tPCS)|One set of sponge electrodes will be placed on the participant's head. The transcranial electrical stimulator will apply unidirectional, positive pulses of current separated by brief interpulse intervals to the scalp via the sponges for 30 minutes.
15953568|NCT03237091|Other|bihemispheric transcranial direct current stimulation (tDCS)|Two sets of sponge electrodes (one set placed on each side of the head) will be placed on the participant's head. The transcranial electrical stimulator will apply continuous, direct current to the scalp via the sponges for 30 minutes.
15953569|NCT03237091|Other|unihemispheric transcranial direct current stimulation (tDCS)|One set of sponge electrodes will be placed on the participant's head. The transcranial electrical stimulator will apply continuous, direct current to the scalp via the sponges for 30 minutes.
15953570|NCT03237091|Other|sham-control|Sponge electrodes will be placed on the participant's head. The transcranial electrical stimulator will apply stimulation to the scalp via the sponges for 1-2 minutes. The stimulator will then be turned off.
15953571|NCT03237078|Dietary Supplement|Lactobacillus plantarum PS128|Each PS 128 capsule contains 300 mg of probiotics. PS128 will be provided 300 mg twice, in the morning and in the afternoon, daily.
15953572|NCT03237065|Drug|Iron isomaltoside/ferric derisomaltose|"Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.
~The dose of iron isomaltoside/ferric derisomaltose for the individual subject was a single IV infusion of 1000 mg (10 mL containing 1000 mg iron isomaltoside/ferric derisomaltose diluted in 100 mL 0.9 % sodium chloride), given over approximately 20 minutes (50 mg iron/min) at baseline (cumulative dose: 1000 mg)."
15953573|NCT03237065|Drug|Ferric carboxymaltose|Ferric carboxymaltose (Injectafer®; 50 mg/mL) was the comparator in this trial. The dose of ferric carboxymaltose for the individual subject was 750 mg, infused over at least 15 minutes at baseline and on day 7 (cumulative dose: 1500 mg).
15953574|NCT03237052|Other|model|a model that has been established in advance.
15953575|NCT03237052|Other|non-model|real-world psychiatrist decision
15953576|NCT03237039|Radiation|X-ray examination|Radiological examination of frontal and lateral planes, simultaneously acquired with low dose X-ray system (EOS system, France) in one single exposition. The evaluation of the radiographic images will be performed by an orthopedic physician.Image processing will be performed by a biomedical engineer through sterEOS proprietary software and will provide the anatomical parameters needed to classify the sagittal profile.
15953577|NCT03237039|Other|fall-risk assessment|This evaluation will be performed after the radiographic scan, in the same day. The fall-risk assessment test will be performed by a biomedical engineer through OAK device (OAK, Khymeia, Italy). The OAK device integrates two force plates and sensory elastic straps applied to pelvis and limbs. This test, which takes approximately twenty minutes, accounts eight consecutive postural equilibrium exercises and provide the automatic detection of subject's postural parameters. At the end of the test, the fall-risk rating is automatically assigned.
15953578|NCT03237039|Other|gait cycle analysis|This assessment will be performed in the same session of fall-risk evaluation. The gait cycle analysis, which takes approximately forty minutes, will be executed by a biomedical engineer. Adhesive passive reflective markers will be placed on the skin according to a protocol suitable to characterize the alignment of lower limbs and trunk. The markers trajectories during walk will be recorded by an eight cameras optoelectronic system (BTS smart-D, Italy). A force platform (Kistler, Switzerland) placed in the middle of the pathway will detect the forces exchanged with the ground. The data analysis will provide the kinematic and kinetic descriptive parameters of gait cycle.
15953579|NCT03237026|Other|No intervention required|No intervention required
15953580|NCT03237013|Behavioral|Facial Morphing Intervention|Participants assigned to this condition were exposed to facial morphing technology that displays the progression of facial-ageing up to 72years, both with and without damage from UV exposure.
15953581|NCT03237013|Behavioral|Mindfulness Intervention|Participants assigned to this condition engaged in a self-guided mindfulness intervention audio tape. This intervention instructed participants to pay attention to the present moment, with a non-judgemental stance. For example, participants were instructed to notice their breath, thoughts, feelings, physical sensations, and to internally describe them, without passing judgement
15953582|NCT03237000|Drug|MgSO4|"Magnesium sulphate was administered by continuous intravenous infusion according to our hospital protocol as follows:
~Loading dose: 4-6 gm of magnesium sulphate diluted in 100 mL of IV fluid administered over 15-20 min.
~Maintenance dose: 2 gm/hr in 100 mL of IV infusion to be continued for 24 hours after delivery."
15953583|NCT03236987|Drug|Clarithromycin 1000 MG|The patient will be received for at least 12 months, a daily antibiotic treatment who is a combination of Clarithromycin, Ethambutol and Rifampicin.
15953584|NCT03236987|Drug|Azithromycin 250 mg|The patient will be received for at least 12 months, a daily antibiotic treatment who is a combination of Azithromycin, Ethambutol and Rifampicin.
15953585|NCT03236987|Drug|Rifampicin|The patient will be received for at least 12 months, a dailty antibiotic treatment who is a combination of Azithromycin or Clarithromycin (according to the randomisation), Ethambutol and Rifampicin.
15953586|NCT03236987|Drug|Ethambutol|The patient will be received for at least 12 months, a dailty antibiotic treatment who is a combination of Azithromycin or Clarithromycin (according to the randomisation), Ethambutol and Rifampicin.
15953587|NCT03236974|Drug|Standard Arm - Fulvestrant|500 mg Fulvestrant administered as two consecutive 5 ml intramuscular injections on Day 1, one in each buttock
15953588|NCT03236974|Drug|AZD9496|Administered at 250 mg bd orally for 5-14 days commencing on Day 1, and continuing up to the day of biopsy
15953589|NCT03236961|Drug|Ertapenem|I.v. ertapenem 1 g for 2 days followed by p.o. levofloxacin 500 mg x1 and metronidazole 500 mg x 3 for 5 days
15953590|NCT03236961|Drug|Moxifloxacin|P.o. moxifloxacin 400 mg x1 for 7 days
15953591|NCT03236948|Behavioral|Women for Women International Intervention|
15953592|NCT03236935|Drug|L-NMMA|pan-nitric oxide synthase inhibitor
15953593|NCT03236935|Drug|Pembrolizumab|PD-1 inhibitor
15953594|NCT03236922|Procedure|Pubococcygeus sling|The pubococcygeus muscles is dissected from the vaginal side walls and approximated at the midline just below the urethra.
15953595|NCT03236922|Procedure|Rectus fascia sling|Rectus fascia is dissected out cephalad to the pubic symphysis and tunneled beneath the urethra.
15953596|NCT03236909|Device|MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System|Subjects will be implanted with the MED-EL SYNCHRONY/SYNCHRONY PIN Cochlear Implant System with +FLEX28 or +FLEXSOFT electrode arrays. Subjects will be fit with the SONNETEAS (ear-level) and/or RONDO (single-unit) external audio processors.
15953597|NCT03236896|Behavioral|Exercise|Strength training exercises for older adults. All subjects will complete questionnaire (MENQOL Scale),hot flash diary and wear the fitbit flex for duration of study.
15953598|NCT03236896|Behavioral|No exercise|All subjects will complete questionnaire (MENQOL Scale),hot flash diary and wear the fitbit flex for duration of study.
15953599|NCT03236883|Drug|Gemcitabine|Chemotherapy: Gemcitabine is administered Intravenous injection once a week，at a dose of 1000 mg/m2, for 3consecutive weeks,followed by a 7-days rest,repeated every 4weeks,three times in all.
15953600|NCT03236883|Other|GPBSC|immunotherapy :GPBSC were collected from donor .Cells were infused to the patients in 4 week,at a dose of (2-3)*10^8/kg,once a month,repeated every 4weeks,three times in all.
15953674|NCT03236233|Drug|PC786 - Single doses|Safety and tolerability of single doses
15988088|NCT02977416|Other|anti-TNFα|
15953601|NCT03236857|Drug|chemotherapy|Dexamethasone and/or vincristine and/or pegasparaginase OR cytarabine and/or etoposide and/or pegasparaginase; tyrosine kinase inhibitor; cytarabine OR azacitidine OR decitabine; rituximab and/or dexamethasone and/or vincristine; cyclophosphamide and/or topotecan
15953602|NCT03236857|Drug|venetoclax|Oral tablet for participants; Tablet for oral suspension (participants who cannot swallow a tablet)
15953603|NCT03236844|Drug|Gantenerumab|Gantenerumab HCLF manufactured by either G3 or G4 process will be administered on Day 1 (in the abdomen).
15953604|NCT03236831|Other|Clinical Recommendations|"The investigators will provide clinical recommendations to the subject's primary care provider. These will be in regards to the following:
~Avoidance of potentially nephrotoxic medications.
~Optimizing volume status (avoidance of volume overload or depletion)
~Optimizing electrolytes and acid-base status
~Minimizing IV contrast exposure when appropriate
~Treating severe anemia
~Optimization of hemodynamics (Mean arterial BP>65mmHg)"
15953605|NCT03236818|Drug|ERA and PDE-5I (Sildenafil, Tadalafil, Bosentan, Macitentan)|Combination of an ERA and PDE-5I (Sildenafil, Tadalafil, Bosentan, Macitentan)
15953606|NCT03236805|Drug|Ketamine|Initial bolus of 20 mg (around 0.3 mg per kg) followed by bolus of 10 mg every 5 minutes as reported by the recommandations of experts of the french society of urgency care
15953607|NCT03236805|Drug|Morphine|Bolus of 2 mg (patient with weight under 60 kgs) or bolus of 3 mg (patient with weight above 60 kgs) every 5 minutes as reported by the recommandations of experts of the french society of urgency care
15953608|NCT03236792|Drug|Ixazomib|3 mg or 4mg of Ixazomib will be taken orally on days 1, 8, and 15 of a 28-day cycle
15953609|NCT03236792|Drug|Cyclophosphamide|300, 400, or 500 mg of oral Cyclophosphamide on days 1, 8, and 15 of a 28-day cycle
15953610|NCT03236792|Drug|Dexamethasone|20 mg of oral Dexamethasone on days 1, 8, 15, 22 in a 28-day cycle
15953611|NCT03236779|Other|dry needling|The electrotherapy equipment used (Enruf) produces a continuous galvanic current through the cathode (modified electrosurgical scalpel with the needle) while the patient holds the anode (handheld electrode) (42). Once the needle have reach the relevant treatment area, a continuous current of 3 pulses at an intensity of 3 1.5 mA for 5 seconds conveyed to the muscle will be applied.
15953612|NCT03236766|Other|Citizens' panels|This study is exploratory in nature, designed to capture lay Pacific Islanders' thoughts and beliefs about existing service engagement approaches. Therefore, there are no study arms to list.
15953613|NCT03236753|Procedure|Thread-embedding Acupuncture (TEA)|"The acupoints and size of TEA are as follows:
~Both EX-B2 of herniated intervertebral disc level, its upper level and its lower level (6 acupoints): perpendicular insertion, 4cm
~Both BL24: transverse insertion toward L1 level along the erector muscle of spine, 6cm
~Both BL25: transverse insertion toward iliac crest, 4cm
~Both BL26: transverse insertion toward L1 level along the erector muscle of spine, 6cm
~Both BL26: oblique insertion toward iliolumbar ligament, 6cm
~Both EX-B7: oblique insertion toward gluteus medius muscle, 6cm
~Both BL28: oblique insertion toward sacroiliac ligament, 6cm
~Both GB30: perpendicular insertion, 6cm
~Symptomatic side GB34, BL57 and ST36: oblique insertion toward foot, 4cm"
15953614|NCT03236753|Procedure|Sham Thread-embedding Acupuncture (STEA)|All procedure of STEA group, including acupoints and size of TEA will be same as that of TEA group. However, thread-removed TEA will be used for STEA group instead of normal TEA, and removing procedure of thread will be performed aseptic and secretly for patient-blinding and prevention of infection.
15953615|NCT03236740|Drug|Ethinyl Estradiol-cyprosterone acetate|Ethinyl Estradiol-cyprosterone acetate in the form of OCPs will be taken cyclically by the participants.
15953616|NCT03236740|Drug|Metformin Hydrochloride|Metformin Hydrochoride in the form of 500 mg tablets will be taken twice daily by participants.
15953617|NCT03236727|Drug|Dexmedetomidine|Changes of both amplitude and latency of SSEPs during dexmedetomidine infusion.
15953618|NCT03236701|Other|Egg White replacement|Nutritional intervention: the meat or fish of two meals will be replaced twice a week with an equivalent amount (in protein content) of egg white.
15953619|NCT03236662|Drug|(-)-Epicatechin|
15953620|NCT03236649|Drug|Icaritin|600mg/time, 6 capsules/time(6×100mg/capsule), 2 times/day(30 minutes after breakfast, lunch and dinner), take orally, continuous administration until reach the standard of termination.
15953621|NCT03236649|Drug|Sorafenib Tosylate Tablets|400mg/time, 2 tablets/time(2×200mg/tablet), 2times/day(Fasting), take orally, continuous administration until reach the standard of termination.
15953622|NCT03236636|Drug|Icaritin|Icaritin：600mg/time, 6 capsules/time(6×100mg/capsule), 2 times/day(30 minutes after breakfast, lunch and dinner), take orally, continuous administration until reach the standard of termination.
15953623|NCT03236636|Drug|HUACHANSU PIAN|HUACHANSU PIAN:Take orally 4 tablets/time(0.3g/tablet), 3 times/day(30 minutes after breakfast, lunch and dinner), continuous administration until reach the standard of termination.
15953624|NCT03236623|Other|Menthol Popsicle|The menthol popsicle composed of 0.05% menthol, 0.05% saccharin, 30ml ultrafiltered water and 2% cereal alcohol. The popsicle will have a support that will assist the patient in the administration of the intervention, giving him autonomy and safety in the application of the intervention.
15953625|NCT03236610|Drug|tenofovir monotherapy|switching to tenofovir monotherapy
15953626|NCT03236610|Drug|tenofovir plus entecavir combination|continuing tenofovir plus entecavir
15953627|NCT03236597|Other|Treadmill desk|A standing height desk with a treadmill attached.
15953628|NCT03236584|Drug|lamivudine plus adefovir combination|continuing lamivudine plus adefovir
15953629|NCT03236584|Drug|Tenofovir Disoproxil Fumarate|switching to tenofovir
15953630|NCT03236571|Device|Rehabilitation program|The rehabilitation program will consist of a Personalized Training Program and a muscle building program.
15953631|NCT03236558|Procedure|Blood collection|Ten cc of peripheral blood will be taken from patients and healthy controls as soon as possible after T1D diagnosis of the former.
15953632|NCT03236545|Other|No to Low Endogenous Estrogen|Ganirelix acetate (Antagon) will be used to prevent endogenous production of ovarian hormones in young women. Ganirelix is derived from native GnRH, and acts by competitively blocking GnRH receptors on the pituitary and subsequent pathways. Thus, administration of the GnRH antagonist (GnRHant) suppresses steroidogenesis, leading to low or undetectable serum estrogen and progesterone concentrations, which occurs within two days of initiation of administration (Oberye, Mannaerts, Huisman & Timmer, 1999; Oberye, Mannaerts, Kleijn, & Timmer, 1999).
15953675|NCT03236233|Drug|Placebo - Single doses|Safety and tolerability of single doses
15953633|NCT03236545|Other|Estradiol|Short term estradiol administration elicits changes in vascular function in women, and 0.1mg/day patch is the upper recommended limit for hormone therapy in women (Wenner, Taylor, & Stachenfeld, 2011; Moreau, Hildreth, Meditz, Deane & Kohrt, 2012).
15953634|NCT03236532|Dietary Supplement|Glutamine and exercise|
15953635|NCT03236532|Dietary Supplement|Maltodextrin and exercise|
15953636|NCT03236506|Drug|Zepatier Pill|Drugs will be given to participants to treat hepatitis C infection
15953637|NCT03236506|Behavioral|Psychological intervention|"Participants randomised to fortnightly pick-up with psychological intervention will have an interview with the study nurse designed to aid their compliance with the drug regimen. During the intervention participants will be guided by their trial nurse in the completion of a personalised booklet, Hepatitis C and Me. The booklet uses the principles of node-link mapping to structure the intervention."
15953638|NCT03236506|Drug|Sofosbuvir Pill|Drugs will be given along with Zepatier to participants to treat genotype 3hepatitis C infection
15953639|NCT03236493|Drug|PF-06700841|PF-06700841 will be administered as tablet
15953640|NCT03236493|Drug|Placebo|Matching placebo will be administered as tablet
15953641|NCT03236467|Behavioral|Progressive Exercise Training|Designed to ease primarily sedentary individuals into exercise training, increasing in intensity up to 80% of maximum Heart Rate Range over time.
15953642|NCT03236454|Device|DC-Stimulator MC, NeuroConn|20 minutes of 2 mA anodal stimulation; Electrode placement: left dorsolateral prefrontal cortex (F3, EEG 10/20 system), return electrode at the right upper arm.
15953643|NCT03236441|Device|RIPC|Remote ischemic preconditioning
15953644|NCT03236441|Device|Sham-RIPC|Control
15953645|NCT03236428|Drug|Daratumumab|Daratumumab is a drug that may kill or stop cancer cells from growing through a variety of mechanisms by attaching to the CD38 molecule
15953646|NCT03236415|Device|Xience Drug Eluting Stent|Patients will undergo insertion of a drug eluting stent with assessment of strut coverage using optical coherence tomography at 4 to 6 weeks after implantation.
15953647|NCT03236415|Device|ABSORB Bioresorbable Vascular Scaffold|Patients will undergo insertion of a bioresorbable vascular scaffold with assessment of strut coverage using optical coherence tomography at 4 to 6 weeks after implantation.
15953648|NCT03236389|Device|Q Collar|measuring changes in brain during MRI while wearing the Q collar
15953649|NCT03236376|Other|additional sensorimotor therapy for the upper limb|The intervention will consist of additional physiotherapy for the upper limb after stroke consisting of sensory discrimination training and sensorimotor training.
15953650|NCT03236376|Other|additional motor therapy for the upper limb after stroke|The intervention will consist of additional physiotherapy for the upper limb after stroke consisting of cognitive-attention based training and motor training
15953651|NCT03236363|Behavioral|MOVI-da10! active breaks|MOVI-da10! active breaks, is a physical activity intervention that consists on two daily physical activity breaks of 10 minutes of duration (intensity: 4-6 METs, Heart rate ≥150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children
15953652|NCT03236363|Behavioral|MOVI-da10! integrated physical activity|MOVI-da10! integrated lessons, is a physical activity intervention that consists on two daily cognitive demanding physical activity breaks of 10 minutes of duration (intensity: 2-3 METs, Heart rate <150 bpm). It is aimed to enhance physical activity, motor skills and cognition among 5 years old children
15953653|NCT03236350|Device|Active autoRIC® (CRIC Treatment)|The active autoRIC® Device is programmed to go through a preset protocol of inflation and deflation cycles every session. The sessions will be repeated daily for 28 days.
15953654|NCT03236350|Device|Sham Control autoRIC® (Sham Control)|The Sham Control autoRIC® Device is visually identical to the active autoRIC® Device but the simulated protocol applied comprises of vibrations of the device but no inflation of the cuff every session. The sham device provides the same sound and vibration as that of the pump inflating and the same LED indicators on the Active Unit. The sessions will be repeated daily for 28 days.
15953655|NCT03236337|Behavioral|MOVI intervention|MOVI-da Fit! is a multidimensional intervention that consists on: a) 4h/week of a standardized recreative, non-competitive physical activity extracurricular program; and b) informative sessions to parents and teachers about how schoolchildren can became more active. It is aimed to enhance physical fitness, motor skills, physical activity time and active behaviours among 9-to-11 years old children.
15953656|NCT03236324|Device|ultrasound-guided nerve block|Transversalis fascia plane (TFP) block, ultrasound-guided
15953657|NCT03236324|Drug|Saline|20 mL 0.9% saline administered on each side as bilateral TFP blocks
15953658|NCT03236324|Drug|Bupivacaine-epinephrine|20 mL bupivacaine 0.25% with epinephrine 2.5 mcg/mL to a maximum of 2.5mg/kg administered on each side as bilateral TFP blocks
15953659|NCT03236311|Drug|SAR407899|Pharmaceutical form: Capsule Route of administration: Oral
15953660|NCT03236311|Drug|Placebo|Pharmaceutical form: Capsule Route of administration: Oral
15953661|NCT03236311|Drug|Adenosine|Pharmaceutical form: Solution for injection Route of administration: Intravenous
15953662|NCT03236311|Drug|Regadenoson|Pharmaceutical form: Solution for injection Route of administration: Intravenous
15953663|NCT03236311|Drug|13N-ammonia|Pharmaceutical form: Solution for injection Route of administration: Intravenous
15953664|NCT03236311|Drug|82Rubidium|Pharmaceutical form: Solution for injection Route of administration: Intravenous
15953665|NCT03236298|Device|CADD-Solis Ambulatory Infusion System|The CADD-Solis pump will administer programmed intermittent boluses of 0.0625% Bupivacaine plus fentanyl 2mcg/ml.
15953666|NCT03236285|Behavioral|High-intensity interval exercise training in the fed state|High-intensity interval exercise training in the fed state
15953667|NCT03236285|Behavioral|Continous exercise training in the fed state|Continous exercise training in the fed state
15953668|NCT03236285|Behavioral|High-intensity interval exercise training in the fasting state|High-intensity interval exercise training in the fasting state
15953669|NCT03236285|Behavioral|Continous exercise training in the fasting state|Continous exercise training in the fasting state
15953670|NCT03236259|Dietary Supplement|Brainport high dose|berry extract, high dose. Daily ingestion of capsule
15953671|NCT03236259|Dietary Supplement|Brainport low dose|Berry extract, low dose. Daily ingestion of capsule
15953672|NCT03236259|Dietary Supplement|Placebo|Maltodextrin. Daily ingestion of capsule
15953678|NCT03236220|Drug|N-acetyl-L-cysteine|Acute leukemia patients with complete remission, whose bone marrow endothelial cells were less than 0.1% detected before haploidentical hematopoietic stem cell transplantation, receive N-acetyl-L-cysteine (NAC) (orally at dosages of 400mg 3 times per day). NAC treatment begins from 14 days pre-allotransplant to 2 months after-allotransplant continuously in the absence of disease progression or unacceptable toxicity.
15953679|NCT03236207|Other|Test extensively hydrolyzed formula|extensively hydrolyzed formula with HMOs
15953680|NCT03236207|Other|Control extensively hydrolyzed formula|extensively hydrolyzed formula without HMOs
15953681|NCT03236181|Other|SFA|High saturated fatty acid/SFA oil source
15953682|NCT03236181|Other|MUFA|High monounsaturated fatty acid/MUFA oil source
15953683|NCT03236181|Other|PUFA|High polyunsaturated fatty acid (linoleic)/PUFA oil source
15953684|NCT03236181|Other|LCn3|High polyunsaturated fatty acid (omega-3)/LCn3 oil source
15953685|NCT03236168|Drug|Ivermectin|A single weight based dose of ivermectin
15953686|NCT03236168|Drug|Permethrin 5%|Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated
15953687|NCT03236168|Drug|Malathion Shampoo 0.5%|Permethrin cream is used in conjunction with Malathion shampoo when ivermectin is contra-indicated
15953688|NCT03236155|Drug|opioid pain pills|patient will receive their pain pill prescription
15953689|NCT03236142|Procedure|SIPS Operation|The SIPS modification of the DS operation entails one less division of the small intestine and one less anastomosis, thereby reducing the time of the procedure.
15953690|NCT03236142|Procedure|Standard Duodenal Switch Operation|
15953691|NCT03236129|Procedure|T-reg depleted DLI|The patients in the experimental arm benefit of a DLI depleted from regulatory T lymphocytes
15953692|NCT03236129|Procedure|Standard DLI|The patients in this arm benefit of a standard DLI.
15953693|NCT03236116|Other|Almonds|Participants will consume almonds everyday for 6 months.
15953694|NCT03236116|Other|Control (no nuts)|Participants will not be permited to consume any nuts for 6 months.
15953695|NCT03236103|Other|Clinical Recommendations|"The clinical recommendations will regard the following:
~Avoidance of potentially nephrotoxic medications (e.g. NSAIDs, intravascular contrast, nephrotoxic antimicrobials)
~Optimizing volume status (avoidance of volume overload or depletion)
~Optimizing electrolytes and acid-base status
~Optimizing hemodynamics (Mean arterial BP>65mmHg)
~Assessment of kidney function with serum creatinine and/or cystatin C
~None of the suggestions will be experimental. All suggestions will be based on standard nephrology practice."
15953696|NCT03236090|Dietary Supplement|Vivomixx|Vivomixx®sachets containing 450 x 109 bacteria, 2 every 12 hours (n=25), or placebo (n=25)
15953698|NCT03236064|Drug|Polyethylene Glycols|Demonstrate more rapid and increased return of function by PEG-fusion compared to best current nerve repair techniques
15953699|NCT03236051|Procedure|Multimodal analgesia|Multimodal analgesia is the name of a procedure or program. Multimodal analgesia doesn't mean different interventions are used. Patients in this group need receive this analgesia program (procedure) instead of one analgesic drug or technology. The program consists of incision infiltration with ropivacaine, intravenous injection of parecoxib, and oral administration of oxycodone/paracetamol mixture.
15953700|NCT03236051|Procedure|PCIA analgesia|PCIA analgesia:patient-controlled intravenous analgesia with tramadol.
15953701|NCT03236038|Diagnostic Test|Labeled triolein urea breath test|"The diagnosis of EPI will be made through the combination of two diagnostic tests.
~The labeled triolein breath test will use criteria established by the manufacturer of the product (Pancreo-Kit®) Isomed pharma.
~The fecal elastase test will be performed at our own center (Bioserv Diagnostics (BS-86-01 Elastase Pancreatic ELISA) distributed by Palex Medical.) In those cases where both results are negative, it will be considered that there is no EPI. In cases where both results are positive, the diagnosis of EPI will be performed. If the results are discordant, a Sobel test or feces quantification test will be performed."
15953702|NCT03236025|Combination Product|Video+brief smoking cessation+pamphlet|The videos presented the health effects of smoking, especially emphasizing the importance of smoking cessation on pregnant women, fetuses, and newborns.
15953703|NCT03236025|Combination Product|Text-message+brief smoking cessation+pamphlet|The text -message contains the same content with the videos
15953704|NCT03236025|Other|brief smoking cessation+pamphlet|"The pamphlet showed the general information related to the smoking cessation, the brief smoking cessation only contains a sentence like You'd better quit smoking."
15953705|NCT03236012|Drug|Botulinum Toxin Type A (Botox)|Maximum dose up to 400 units given one time
15953706|NCT03235986|Drug|nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part I)|Single ascending doses of Curosurf® administered through nebulisation to neonates receiving nCPAP (Part I)
15953707|NCT03235986|Drug|nCPAP (nasal Continuous Positive Airway Pressure) + Nebulised Curosurf® (Part II)|Two doses of Curosurf® administered through nebulisation to neonates receiving nCPAP (Part II)
15953708|NCT03235986|Other|nCPAP (nasal Continuous Positive Airway Pressure) alone (Part I)|Nasal continuous positive airway pressure alone
15953709|NCT03235986|Other|nCPAP (nasal Continuous Positive Airway Pressure) alone (Part II)|nasal continuous positive airway pressure alone
15953710|NCT03235973|Drug|Fludarabine-Cladribine-Busulfan conditioning regimen|"Conditioning regimen will be performed from day -6 to day -2 and contains:
~Fludarabine 10 mg/m²/d during 5 days (day-6 to day-2).
~Cladribine during 5 days (day-6 to day-2) at one the following define dose level:
~Dose 1: 10 mg/m²/d
~Dose 2: 15 mg/m²/d
~Dose 3: 20 mg/m²/d
~Dose 4: 25 mg/m²/d
~IV busulfan will be given on day-6 using fixed dose as following:
~If age ≤ 60 years: starting dose of 130 mg/m²
~If age > 60 years: starting dose of 100 mg/m² No busulfan will be administered at day-5, allowing the pharmacokinetic (PK) analyses . Subsequent infusion of IV busulfan will be performed from day-4 to day-2 at the dose recommended by PK analyses"
15953711|NCT03235960|Device|glass-ionomer fissure sealant|The encapsulated glass-ionomer cement for fissure protection was applied onto the selected permanent molar according to the manufacturer's instruction
15953712|NCT03235947|Drug|Fosfomycin disodium|Fosfomycin disodium 4 g intravenously dissolved in 100 mL of normal saline 0.9% three times in the perioperative period of renal transplant surgery.
15988216|NCT02976519|Drug|Placebo|twice daily
15953713|NCT03235947|Drug|Trimethoprim / Sulfamethoxazole|Trimethoprim / Sulfamethoxazole (160/800 mg) orally every 24 hours during the study follow-up (7 weeks)
15953714|NCT03235947|Drug|Intravenous placebo|Normal saline 0.9% 100 mL intravenous administered three times in the perioperative period of the renal transplant, at the same times corresponding to disodium fosfomycin
15953715|NCT03235921|Drug|Nitroglycerin patch 5mg|application of the nitroglycerin patch 5 mg to each patient in nitroglycerin group
15953716|NCT03235921|Other|placebo|no drug given to the control group
15953717|NCT03235908|Other|Observation only|Observation only
15953718|NCT03235895|Other|Educational material|Educational material given as a part of CME activity as through enhanced internet method
15953719|NCT03235882|Diagnostic Test|LS-ratio|Accurately predict RDS using Lecithin/Sphingomyelin ratio (L/S ratio determined by a rapid FTIR test on fresh gastric aspirates) using retrospective analysis
15953720|NCT03235869|Drug|Durvalumab|Durvalumab 1500mg IV over 1 hour administered within 2-7 days of initiation of radiation, then every 28 days.
15953721|NCT03235869|Radiation|Radiation Therapy|Radiation to 1-3 cutaneous tumors: 20 Gy (4 Gy x 5 fractions)
15953722|NCT03235843|Device|AAIR pacing|Rate adaptive pacing using a MV sensor.
15953723|NCT03235843|Device|DDI-pacing|Rate adaptive pacing OFF
15953724|NCT03235830|Behavioral|Enhanced Standard of Care (ESoC) + Text|See above in arm/group description
15953725|NCT03235830|Behavioral|Enhanced Standard of Care (ESoC)|See above in arm/group description
15953726|NCT03235817|Other|Spontaneous ventilation|The patient will breathe spontaneously (on their own) while under general anesthesia throughout the duration of the surgery.
15953727|NCT03235817|Device|Pressure support ventilation|The patient will breathe on their own and with a little assistance from the anesthesia machine while under general anesthesia throughout the duration of the surgery.
15953728|NCT03235817|Device|Pressure control ventilation|The patient's ventilation will be completely supported by the anesthesia machine while under general anesthesia throughout the duration of the surgery.
15953729|NCT03235804|Dietary Supplement|Soy protein, honey and yogurt.|Participants will be asked to maintain their usual dietary intake and consume a nutritional supplement composed of soy protein, honey and yogurt twice daily (in two snacks) over 12 weeks. The addition of the nutritional supplement to a North American Dietary Pattern (described on the CON group diet) will result in a diet composed of, approximately, 22% of protein, 48% of carbohydrate and 30% of fat of total energy intake. The amount of protein is considered higher than the North American dietary pattern (i.e. 15%); however, still within the Acceptable Macronutrient Distribution Range (AMDR) recommended by the Dietary Guidelines for Americans (10-35%).
15953730|NCT03235778|Drug|Felbinac Trometamol Injection|Felbinac Trometamol Injection will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump
15953731|NCT03235778|Drug|Placebo|Normal saline will be infused IV as a single dose in 100 mL normal saline,in a 30-minute period using a programmable pump
15953732|NCT03235765|Diagnostic Test|MACROGEN Pan Cancer Panel (Tier 2)|This study will utilize a MACROGEN Pan Cancer Panel (Tier 2), which is a hybrid capture-based NGS assay interrogating the coding regions of 170 cancer-related genes.
15953733|NCT03235752|Drug|TJ301 300mg|TJ301 300mg IV infusion
15953734|NCT03235752|Drug|TJ301 600mg|TJ301 600mg IV infusion
15953735|NCT03235752|Drug|Placebo|Placebo IV infusion
15953736|NCT03235739|Drug|Naloxegol 25 MG|Oral Naloxegol 25 MG
15953737|NCT03235739|Drug|Placebo|matching oral placebo
15953738|NCT03235726|Drug|CCI15106|One capsule (single dose or repeat dose) of 30 mg of CCI15106 will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.
15953739|NCT03235726|Drug|Placebo|One capsule of placebo will be administered to healthy subjects and subjects with COPD via inhalation route using Monodose RS01 device. The morning dose will be taken in fasting state and for repeat dose; the evening dose will be taken at least 2 hours after food.
15953740|NCT03235700|Other|Maximal hyperemia with adenosine followed by nicorandil|IV adenosine 140 - IV adenosine 180 - IC adenosine (LCA 200/RCA 100) - IC nicorandil 2
15953741|NCT03235700|Other|Maximal hyperemia with nicorandil followed by adenosine|IC nicorandil 2 - IV adenosine 140 - IV adenosine 180 - IC adenosine (LCA 200/RCA 100)
15953742|NCT03235687|Diagnostic Test|ExoDx Prostate (IntelliScore)|ExoDx Prostate (IntelliScore) is a non-invasive, urinary 3-gene expression validated test in which the results of the assay are adjunctive to the ordering physician's clinical judgment and work-up of the patient in the determination of whether a prostate needle biopsy is necessary. The ExoDx Prostate (IntelliScore) was clinically validated to discriminate patients with higher grade prostate cancer from those with more indolent lower grade cancer and benign disease.
15953743|NCT03235674|Other|High-intensity stair climbing exercise|High intensity stair climbing exercise at a vigorous pace as measured by rating of perceived exertion.
15953744|NCT03235661|Device|BiPAP|BiPAP is used as a primary mode of ventilation in one of the preterm infants with respiratory distress syndrome
15953745|NCT03235661|Device|nCPAP|nCPAP is used as a primary mode of ventilation in another of the preterm infants with respiratory distress syndrome
15953746|NCT03235648|Procedure|cardiophrenic lymph nodes resection|surgical resection
15953747|NCT03235622|Diagnostic Test|Coronary CT angiography|Presence of coronary plaques Characteristic of coronary plaques
15953748|NCT03235609|Drug|Fentanyl|fentanyl used with propofol for sedation
15953749|NCT03235609|Drug|Ketamine|ketamine used with propofol for sedation
15953750|NCT03235596|Device|tDCS|cathodal tDCS applied over the left dorsolateral prefrontal cortex at 2mA during 15 minutes
15953751|NCT03235583|Device|MOTIONPODTM device validation|MOTIONPODTM validation in free-living conditions using gold standards, including the DLW method
15953752|NCT03235570|Drug|Pemigatinib|Pemigatinib at the protocol-defined dose administered once daily.
15953753|NCT03235544|Drug|Parsaclisib|Parsaclisib at the protocol-defined dose.
15953782|NCT03235245|Drug|Nivolumab + Ipilimumab|nivolumab 3 mg/kg q3w + ipilimumab 1 mg/kg q3w for 4 injections followed by nivolumab 480 mg IV q4w until completion of 2 years total treatment or progression.
15953783|NCT03235245|Drug|Encorafenib + Binimetinib|encorafenib 450 mg QD + binimetinib 45 mg BID orally for 12 weeks
15953754|NCT03235531|Drug|Valproate|Valproate is an anti-epileptic medication that can influence the chemical changes in the brain that result from alcohol withdrawal syndrome (AWS) via three mechanisms of action: (1) an increase in GABA activity, (2) inhibition of glutamate binding to NMDA, and (3) restoration of the balance between dopamine and acetylcholine activity. VPA may be effective in the prevention of AWS, and could serve as efficacious adjuvant to traditional benzodiazepine (BZD) therapy for AWS, both decreasing symptoms of AWS and decreasing the use of BZDs.
15953755|NCT03235531|Drug|Lorazepam|Lorazepam is a benzodiazepine used to treat symptoms of AWS. Standard of care at CAMC is monitoring by CIWA tool and administration of lorazepam according to CIWA score.
15953756|NCT03235505|Drug|Nicotine|Nicotine containing e-cigarettes + placebo-varenicline + Motivational Interview (MI)
15953757|NCT03235505|Drug|Varenicline Tartrate|Varenicline + Joytech eGo AIO electronic inhaler but without any nicotine content + MI
15953758|NCT03235505|Behavioral|Motivational Interview|Placebo-varenicline + Joytech eGo AIO electronic inhaler but without any nicotine content +MI
15953759|NCT03235492|Device|SmartAlbu|"Plan:
~Consent an individual
~Measure and record temperature, blood pressure, heart rate, height and weight
~Obtain two samples of saliva for the SmartAlbu portable salivary sensor
~Take a venous blood sample for HbA1c and
~Glycated albumin
~Obtain blood sample from a finger stick for point of care HbA1c device"
15953760|NCT03235479|Drug|Rimegepant|75 mg tablet QD
15953761|NCT03235479|Drug|Placebo|Placebo tablet to match rimegepant dose QD
15953762|NCT03235466|Behavioral|Voice Therapy|See Arm 1 & 2
15953763|NCT03235466|Behavioral|Voice Therapy and Heart Rate Variability Biofeedback|See Arm 2 & 3
15953764|NCT03235466|Behavioral|Heart Rate Variability Biofeedback|See Arm 2 & 3
15953765|NCT03235453|Other|Binary rhythm|The binary rhythm intervention will be performed using the dance modalities, Forró, Merengue and Bolero. It will occur twice a week for 12 weeks with 45 minutes of sitting.
15953766|NCT03235453|Other|Quaternary rhythm|The quaternary rhythm intervention will be performed using the modalities of dance, Tango, Salsa, Zouk. It will occur twice a week for 12 weeks with 45 minutes of sitting.
15953767|NCT03235440|Behavioral|Kids N Fitness Program|Participants will engage in a one-week weight-management summer camp consisting of different activities related to moderate-vigorous physical activity (MVPA) and healthy eating. MVPA will consist of modifiable games and activities using a variety of equipment familiar to children of this age, such as balls, hula-hoops, Frisbees, etc., in both competitive and cooperative formats that keep participants moving at all times, and emphasize a feeling of play as opposed to a feeling of exercise. Healthy eating activities are composed of varying classroom-style learning and practical application of knowledge to topics such as recommendations from the MyPlate.gov website, the different types of food groups, and caloric intake and portion sizes, among other various topics.
15953768|NCT03235414|Device|MRI|Will receive a one time research MRI (MR elastography)
15953769|NCT03235414|Diagnostic Test|Blood draw|Will receive a one time blood draw to confirm healthy liver status
15953770|NCT03235401|Other|37-items questionnaire|Patient will answer the PAH-DBoQ questionnaire
15953771|NCT03235388|Other|Audit filters|Institutional implementation of audit filters
15953772|NCT03235375|Drug|MEDI0382|MEDI0382 administered subcutaneously
15953773|NCT03235362|Drug|YHR1705|Subjects will receive multiple oral doses of YHR1705 QD for 5 consecutive days in each period.
15953774|NCT03235362|Drug|YHR1706|Subjects will receive multiple oral doses of YHR1706 QD for 5 consecutive days in each period.
15953775|NCT03235362|Drug|YHR1705+YHR1706|Subjects will receive multiple oral doses of YHR1705 + YHR1706 QD for 5 consecutive days in each period.
15953776|NCT03235349|Drug|Glecaprevir/Pibrentasvir|Coformulated tablet for oral administration
15953777|NCT03235323|Device|External Counterpulsation|ECP is a non-invasive method which consists of three sets of pneumatic cuffs attached to each of the patient's legs at the calf and lower and upper thigh. The inflation of the cuffs is triggered by a computer, and timing of the inflation is based on the R wave of the electrocardiogram. The ECP therapist adjusts the inflation and deflation timing to provide optimal blood movement per a finger plethysmogram waveform reading. This produces a retrograde flow of blood in the aorta resulting in a diastolic augmentation of blood flow and also an increase in venous return, which leads to an improved coronary perfusion pressure during diastole.
15953778|NCT03235284|Other|Exercises|A program of therapeutic exercises (GC) based on the PNF method for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes. The GC treatment program consists of the following protocols: a) protocol 1: 20 minutes diagonal exercise upper limb (flexion-abduction-external rotation and extension-abduction-internal rotation),10 minutes diagonal exercise scapula (anterior and posterior elevation) and 10 minutes of exercise for trunk extension; b) protocol 2: 20 minutes diagonal exercise lower limb (flexion-abduction-external rotation and flexion-abduction-internal rotation),10 minutes diagonal exercise pelvis (anterior and posterior depression), and 10 minutes gait cycle training
15953779|NCT03235284|Other|Nintendo Wii|"Nintendo Wii program (GW) based on the use of the NW for a period of two months, with sessions two times a week for 50 minutes (a total of 16 sessions).All treatment groups prior to perform the study interventions,stretches of upper and lower limbs for 10 minutes.
~The GW treatment program consists of the following protocols: a) protocol 1 games (Boxing and Soccer); b) protocol 2 games (Golf and running). 20 minutes for each game"
15953780|NCT03235284|Other|Exercises and Nintendo Wii|In GCW program will be performed 20 minutes GC protocol (1 or 2, used alternately between sessions a week) and 20 minutes GW protocol (1 or 2, used alternately between sessions a week), taking the time of the performed activities halved in both protocols
15953781|NCT03235271|Device|BrainPulse Device|"The BrainPulse is used on a patient's head to non-invasively detect, amplify and capture the skull motion caused by pulsatile cerebral blood flow from the cardiac cycle.
~The BrainPulse consists of a reusable headset that contains the accelerometers used to measure motion caused by pulsatile cerebral blood flow. The system is powered by a rechargeable battery pack. The headset is placed on the subject's head and outputs data to a data collector that forwards the data to the computer. Each accelerometer has an attached tip that makes contact with the subject's head through hair. The headset also includes a photoplethysmograph (PPG) that simultaneously captures the subject's heart-rate information. There is no energy delivered to the brain or subject by these highly sensitive sensors."
15953784|NCT03235232|Drug|BREMEN eye drops|1 drop in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks.
15953785|NCT03235232|Drug|Combigan®|1 drop of Combigan® in the affected eye(s), twice a day (approximately each 12 hours) for 8 weeks.
15953786|NCT03235219|Drug|JNJ-64565111|Participants will receive JNJ-64565111 subcutaneously in the abdomen on Days 1, 8, 15 and 22.
15953787|NCT03235219|Drug|Placebo|Participants will receive placebo subcutaneously in the abdomen on Days 1, 8, 15 and 22.
15953788|NCT03235206|Other|Massage Therapy|This study will compare surveys taken before the participants began their massage treatments, and after 12 one hour massages. These surveys will judge sleep quality, stress levels, and mental health during varying days in the participants work cycle. It will also compare a postural assessment and range of motion testing done before the first treatment and after the last.
15953789|NCT03235193|Other|Severe Sepsis Prediction|Upon receiving an InSight alert, healthcare provider follows standard practices in assessing possible (severe) sepsis and intervening accordingly.
15953790|NCT03235193|Other|Severe Sepsis Detection|Upon receiving information from the severe sepsis detector in the CHH electronic health record, healthcare provider follows standard practices in assessing possible (severe) sepsis and intervening accordingly.
15953791|NCT03235180|Drug|Sulfur Hexafluoride|Subjects will receive ultrasound (US) imaging of the terminal ileum without and with sulfur hexafluoride contrast at baseline, 4 week and 6 months. Subjects will receive one to two milliliters of the contrast agent.
15953792|NCT03235180|Device|Ultrasound Elastography|Subjects will receive US Imaging with the GE Logiq E9 Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast.
15953793|NCT03235180|Device|Ultrasound Vascularity|Subjects will receive US Imaging with the Verasonics Ultrasound Scanner at baseline, 4 week and 6 months without and with contrast.
15953794|NCT03235180|Device|Magnetic Resonance Enterography (MRE)|Subjects will receive MRE imaging at baseline and 6 months as part of regular clinical care.
15953795|NCT03235167|Drug|CpG DNA|CpG DNA concentrate
15953796|NCT03235167|Procedure|transcatheter arterial chemoembolization|transcatheter arterial chemoembolization (TACE) therapy for liver cancer
15953797|NCT03235167|Drug|Placebo - Concentrate|CpG DNA vehicle
15953798|NCT03235154|Drug|sofosbuvir/velpatasvir|12 week treatment with once daily sofosbuvir/velpatasvir fixed dose combination therapy. Tablets are formulated with 400mg sofosbuvir and 100mg velpatasvir in pink, diamond-shaped, film coated tablets.
15953799|NCT03235141|Drug|azithromycin eye drops by essex|azithromycin eye drops,2.5ml/25mg,by ZHUHAI ESSEX BIO-PHARMACEUTICAL),
15953800|NCT03235141|Drug|azithromycin eye drops|azithromycin eye drops,2.5ml/25mg ,by Oak Pharmaceuticals, Inc subsidiary of Akorn, Inc
15953801|NCT03235128|Diagnostic Test|‗Urine analysis ‗Urine protein quantification ‗Serum albumin ‗Lipid profile.Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood.|Specific tests Quantitation of miRNA -30a by Real-time polymerase chain reaction (Q-PCR) in peripheral blood
15953802|NCT03235115|Device|Methafilcon A IV|Contact Lens
15953803|NCT03235115|Device|Ocufilcon B|Contact Lens
15953804|NCT03235115|Device|Omafilcon A|Contact Lens
15953805|NCT03235102|Other|No treatment given|Completion of a survey
15953806|NCT03235089|Device|Test Lens|Daily disposable contact lens
15953807|NCT03235089|Device|Control Lens|Focus Dailies All Day Comfort contact lens (nelfilcon A)
15953808|NCT03235076|Drug|BAY1101042|Single oral dose of 10 mg BAY 1101042 (given as 5 mg MR tablets)
15953809|NCT03235063|Other|routinely care- no intervention|routinely care- no intervention
15953810|NCT03235050|Drug|MEDI0382 low dose|Pharmaceutical form: solution Route of administration: subcutaneous
15953811|NCT03235050|Drug|MEDI0382 mid dose|Pharmaceutical form: solution Route of administration: subcutaneous
15953812|NCT03235050|Drug|MEDI0382 high dose|Pharmaceutical form: solution Route of administration: subcutaneous
15953813|NCT03235050|Drug|Placebo|Pharmaceutical form: solution Route of administration: subcutaneous
15953814|NCT03235050|Drug|Liraglutide|Pharmaceutical form: solution Route of administration: subcutaneous
15953815|NCT03235037|Drug|Levodopa|The target dose of Sinemet is 2-10 mg per kilogram per day of levodopa. The initial dose will be determined by your weight and age and will start at a low dosage level, 1 mg per kilogram per day. The dose will be re-evaluated after the first 2 weeks and may be adjusted at each visit depending on your response to the drug.
15953816|NCT03235024|Biological|B244|B244 suspension
15953817|NCT03235024|Biological|Vehicle|Vehicle suspension
15953818|NCT03234998|Device|motor-cognitive dual-task training|Participants in the motor-cognitive dual-task training group will will receive an individually-progressed program of dual-task balance/gait training aimed at improving standing balance, sit-to-stand, and walking abilities under motor-cognitive dual-task conditions.
15953819|NCT03234998|Device|cognitive dual-task training|Participants in the cognitive dual-task training group will perform only cognitive tasks (verbal fluency tasks, calculation tasks, and visual discrimination tasks) concurrently with the balance/gait tasks.
15953820|NCT03234985|Biological|Biological analyses|Biological analyses will be realized on samples collected before induction treatment and at the end of bone marrow aplasia i.e. about day 30 to determine the nucleotide pools in peripheral blood mononuclear cells.
15953821|NCT03234972|Drug|Daratumumab|Daratumumab will be administered on Day 1 of Cycles 4-9, and then q4w thereafter.
15953822|NCT03234972|Drug|Velcade|Velcade will be administered at a dose of 1.3 mg/m^2 SC on Days 1, 4, 8 and 11 of each 21-day cycle.
15953823|NCT03234972|Drug|Dexamethasone|Dex will be administered orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11 and 12 of the first 8 Velcade treatment cycles.
15953824|NCT03234959|Device|CareToy intervention|Infants will perform goal directed activities inside the CareToy System
15953825|NCT03234959|Other|Infant Massage|Infants will received IM by their parents
15953826|NCT03234946|Behavioral|CAIPaDi|Patients are attended in 1 day by 9 specialists (endocrinologist, diabetes educators, nutritionist, psychologist, physical activity specialist, foot care and ophthalmologist). They are attended in 4 monthly visits. After the initial phase, patients come back to the Center at 1 and 2 years for evaluation and reinforcement
15953827|NCT03234933|Other|Mobility Tracker|Tracking Patient's movements and calories
15988743|NCT02972840|Drug|Placebo|Placebo comparator
15953828|NCT03234920|Dietary Supplement|BETA-HYDROXY-BETA-METHYLBUTYRATE (HMB)|1.5 g of HMB dissolved in 200 ml of fruit juice will be provided for 12 weeks twice daily
15953829|NCT03234920|Other|Placebo|The placebo will be 200 ml of fruit juice given twice daily
15953830|NCT03234907|Drug|Vedolizumab IV|Vedolizumab IV infusion
15953831|NCT03234907|Drug|Placebo|Vedolizumab placebo-matching
15953832|NCT03234894|Device|SiteSeal Endovascular|to evaluate the safety of the SiteSeal™ Endovascular Adjunctive Compression Device across a broad array of patients undergoing interventional endovascular procedures.
15953833|NCT03234881|Behavioral|MOVE!|Participants randomized to the MOVE! arm will attend 16 weeks of 60-minute weekly groups that are led by a physical therapist, dietician, and/or clinical health psychologist. Clinicians utilize materials available online and encourage the use, but do not require or provide food diaries.
15953834|NCT03234881|Behavioral|MOVE!+gshCBT|Participants randomized to the MOVE!+gshCBT arm will attend the 16 weeks of 60-minute weekly MOVE! Treatment groups, along with up to 10 individual sessions over a 3-month period. Participants will also be given a patient treatment manual to read at home, food diaries that will be expected to be completed on a daily basis, and partake in a walking program to gradually increase daily physical activity.
15953835|NCT03234868|Device|Impression procedure|Each patient will go through both type of impression during single appointment: first the digital impression and then the conventional one (to avoid residual impression materials for the optical impressions). The time necessary for each procedure will be recorded.
15953836|NCT03234868|Device|Crown manufacturing procedures|Test and control implant crowns will be screw-retained on a multi-unit abutment. The conventional crown will be made of a Zirconia framework veneered with cosmetic ceramics directly screwed on the multi-unit platform (no titanium base). The experimental crown will be made in full zirconia and designed in the TRIOS software.
15953837|NCT03234855|Device|LMD|Physician uses LMD to measure defect during procedure.
15953838|NCT03234842|Radiation|Proton Beam Therapy|59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses
15953839|NCT03234842|Radiation|Photon Radiation Therapy|59.4 Gy (RBE) in 1.8 Gy per fraction plus weekly chemotherapy at standard doses
15953840|NCT03234842|Drug|Chemotherapy|Concurrent weekly chemotherapy at standard doses
15953841|NCT03234816|Drug|Norepinephrine 0.05 mcg /Kg/min|Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia
15953842|NCT03234816|Drug|Norepinephrine 0.1 mcg /Kg/min|Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia
15953843|NCT03234816|Drug|Norepinephrine 0.15 mcg /Kg/min|Norepinephrine infusion by rate of 0.05 mcg /Kg/min after spinal anesthesia
15953844|NCT03234816|Drug|Bupivacaine|10 mg Bupivacaine intra-thecal for spinal anesthesia
15953845|NCT03234803|Other|poly-amide|new denture base material
15953846|NCT03234803|Other|poly-methyl methacrylate|gold standard for denture base materials
15953847|NCT03234790|Other|Filtered Air Exposure|Exposure to Filtered air
15953848|NCT03234790|Other|Diesel Exhaust Exposure|Diesel exposure to different concentrations at different times: 20, 50 and 150ug/m3
15953849|NCT03234777|Behavioral|Whiteboard animation video|Developed via qualitative research with parents of children with acute gastroenteritis.
15953850|NCT03234777|Behavioral|Regular video|Developed by CDC
15953851|NCT03234764|Other|Immunotherapy|
15953852|NCT03234751|Drug|Continous IV infusion of Nesiritide|Nesiritide (fhBNP) administered by continuous IV infusion during 48 hours.
15953853|NCT03234751|Drug|Hyperinsulinemic euglycemic clamp|48 hours IV infusion of nesiritide on insulin sensitivity (IS) measured by two-step hyperinsulinemic euglycemic clamp in obese nondiabetic insulin resistant subjects.
15953854|NCT03234751|Drug|Placebo|48 hours of placebo.
15953855|NCT03234738|Drug|TP-271|multiple oral doses of TP-271 or placebo, dosed once daily for 7 days, randomized 3:1, doses escalating as 0.5 mg/kg, 1.0 mg/kg, 2.0 mg/kg, 2.5 mg/kg, and 3.0 mg/kg
15953856|NCT03234738|Drug|Placebo|Placebo is sterile 0.45% saline randomized 3:1 to receive
15953857|NCT03234712|Drug|ABBV-321|Intravenous infusion
15953858|NCT03234699|Drug|Cenobamate|12.5 mg q.d.(Days 13-26), 25 mg q.d. (Days 27-40), 50 mg q.d. (Days 41-54), 100 mg q.d. (Days 55-70), 150 mg q.d. (Days 71-84), 200 mg q.d. (Days 85-110)
15953859|NCT03234699|Drug|midazolam|2 mg midazolam syrup (Days 7, 69, 105)
15953860|NCT03234699|Drug|Warfarin Pill|5 mg (Days 7 and 105)
15953861|NCT03234699|Drug|Omeprazole Pill|20 mg (Days 7 and 105)
15953862|NCT03234699|Drug|Bupropion Pill|150 mg (Days 1 and 99)
15953863|NCT03234686|Drug|Deferiprone 600mg delayed release tablets|The active substance, Deferiprone, is a member of the 3-hydroxypyrid-4-one class of iron chelators, which have a high affinity for ferric iron, binding it in a 3:1 (Deferiprone:iron) molar ratio.
15953864|NCT03234686|Drug|Placebo Oral Tablet|The placebo will mimic the Deferiprone arm in every way, except the placebo will not include the active ingredient
15953865|NCT03234673|Drug|Tacrolimus ointment|3 sessions of fractional CO2 laser one month apart Patients will start treatment Tarolimus ointment twice daily for 3 months.
15953866|NCT03234673|Drug|calcipotriol ointment|3 sessions of fractional CO2 laser one month apart Patients will start treatment Calcipotriol ointment twice daily for 3 months.
15953867|NCT03234673|Drug|NB-UVB|3 sessions of fractional CO2 laser one month apart Patients will start treatment NB-UVB phototherapy twice weekly for 3 months
15953868|NCT03234660|Drug|Dexmedetomidine Hydrochloride|dexmedetomidine 1mcg/kg loading and 0.5mcg/kg/hr continuous infusion during surgery
15953869|NCT03234660|Other|control|0.9% normal saline continuous infusion
15953870|NCT03234647|Device|Doraya catheter|Temporary deployment of the Doraya catheter in AHF patients.
15953871|NCT03234634|Procedure|endovascular thrombectomy|"Intervention description : Group 1: patients with good collateral, Group 2: patient with poor collateral
~Group 1 patients (good collateral group) will receive endovascular thrombectomy using stent retriever, aspiration catheter, or both, if femoral puncture is possible between 150 minutes and 600 minutes after last seen well.
~Group 2 patients (poor collateral group) will be randomized into endovascular thrombectomy group (2a) and best medical treatment group (2b), if femoral puncture is possible between 150 minutes and 600 minutes after last seen well."
15953872|NCT03234621|Other|ventilator setting during one-lung ventilation|providing various tidal volumes according to the groups with constant PEEP
15953874|NCT03234595|Drug|Cerebraca wafer|Eligible patients will receive Cerebraca wafer implantation with adjuvant temozolomide (TMZ) for the safety and efficacy in this study. At Phase I, the MTD will be determined by DLT. At Phase IIa, up to 12 evaluable patients will be enrolled for the efficacy and safety of Cerebraca wafer implantation. At Phase IIa, the cavity surface after tumor removal will be maximally covered by Cerebraca wafer without exceeding the MTD defined at Phase I. Patients in Phase I receive treatment as designed for Phase IIa, the data will be incorporated into Phase IIa to reduce the patient number. The overall patient number in this study is therefore between 2 to 36 evaluable patients.
15953875|NCT03234569|Procedure|sonoHSG|This procedure uses agitated saline to produce air bubbles at the time of the Sonohysterogram which optimizes fallopian tube visualization. The sonoHSG is free of radiation and use of contrast. In this study, in order to produce the air bubbles at the time of the sonohysterogram, the investigators will be using a continuous saline-air device that may produce a technically superior image. For the ultrasound images, General Electric will be supporting us by providing us the Voluson E10 and RIC5-9-D.
15953876|NCT03234556|Procedure|Biopsy of Prostate|Undergo SR-Bx
15953877|NCT03234556|Other|Laboratory Biomarker Analysis|Correlative studies
15953878|NCT03234556|Diagnostic Test|Magnetic Resonance Imaging|Undergo MRI
15953879|NCT03234556|Diagnostic Test|MRI Ultrasound Fusion Guided Biopsy|Undergo MRUS-Bx
15953880|NCT03234543|Procedure|Remote ischemic conditioning|Placement of blood pressure cuff to lower extremity in order to induce temporary and reversible ischemia.
15953881|NCT03234543|Procedure|No Remote ischemic conditioning|Placement of blood pressure cuff to lower extremity with minimal inflation without inducing ischemia.
15953882|NCT03234517|Drug|Vaginal Clindamycin Cream|Vaginal Clindamycin Cream
15953883|NCT03234517|Drug|Vaginal Probiotic|Vaginal Probiotic
15953884|NCT03234491|Device|DiAS|Diabetes Assistant (DiAS) hybrid closed loop system.
15953885|NCT03234491|Drug|Afrezza low dose|Afrezza inhaled insulin low dose.
15953886|NCT03234491|Drug|Afrezza high dose|Afrezza inhaled insulin high dose.
15953887|NCT03234478|Other|cognitive assessments|Cognitive assessments will be performed at baseline, 1 year, and 2 years, depending on subject cohort placement
15953888|NCT03234465|Biological|AG013|AG013 is made up of genetically modified (GM) bacteria called Lactococcus lactis (L. lactis). Wild type L. lactis are commonly used to produce dairy products including cheeses and milk. To make AG013, the DNA of L. lactis has been changed in the laboratory to secrete a protein called human Trefoil Factor 1 (hTFF1). hTFF1 is normally secreted in saliva and intestines. Trefoil factors have been shown to be important in protecting and healing mucosal tissues, such as the tissue in the mouth, when these tissues are damaged by cancer therapies such as chemotherapy and radiation therapy.
15953889|NCT03234465|Other|Placebo|Subjects assigned to the placebo group will receive appearance- and taste-matched placebo powder.
15953890|NCT03234452|Dietary Supplement|Lactoflorene plus|2 vials with dosing cap (10 mL) a day per os
15953891|NCT03234452|Dietary Supplement|Placebo Lactoflorene plus|2 vials with dosing cap (10 mL) a day per os
15953892|NCT03234439|Behavioral|myStrength|myStrength is a digital self-care behavioral and wellness platform
15953893|NCT03234426|Other|Perturbation|Manual perturbations were given at waist region,over the Shoulders. in following positions- sitting, kneeling, standing positions,10 perturbations were given in forward,backward,both right and left side, 6 days in a week all precautionary measures taken for the patient's safety
15953894|NCT03234426|Other|Conventional Physiotherapy Treatment|Conventional Physiotherapy treatment were given to participants included in this group for 30 mins daily for 4 weeks
15953895|NCT03234413|Drug|Botulinum toxin type A|Botulinum toxin type A
15953896|NCT03234400|Combination Product|Dapivirine Vaginal Ring, 25 mg|Vaginal Ring containing 25 mg dapivirine
15953897|NCT03234400|Combination Product|Dapivirine Vaginal Ring, 100 mg|Vaginal Ring containing 100 mg dapivirine
15953898|NCT03234400|Combination Product|Dapivirine Vaginal Ring, 200 mg|Vaginal Ring containing 200 mg dapivirine
15953899|NCT03234387|Other|No intervention - only assessments.|No intervention only a number of assessments. Participants will be assessed during a maximal cardiopulmonary exercise testing on an exercise bike during 1 visit, and before and after an oral glucose tolerance test on a following visit.
15953900|NCT03234374|Combination Product|INL-001 (bupivacaine HCl collagen implant)|3 x 100 mg INL-001 bupivacaine HCl collagen-matrix implants (total bupivacaine HCl dose 300 mg)
15953901|NCT03234374|Drug|Marcaine 0.25% infiltration|Marcaine 0.25% (bupivacaine HCl) 175 mg infiltration
15953902|NCT03234361|Dietary Supplement|High Phosphate Phase|2 capsules of sodium phosphate with 500mg/day of phosphate.
15953903|NCT03234361|Dietary Supplement|Low Phosphate Phase|2 capsules of sodium chloride.
15953904|NCT03234348|Device|Percutaneous coronary intervention|PCI + stent implantation
15953905|NCT03234335|Other|Data collection|Myeloma patients with severe renal impairment who are susceptible to undergo autologous transplantation will be followed in this study, and data related to the pathology, treatments and transplantation will be reported.
15953906|NCT03234322|Other|external validated risk prediction model|The risk prediction model will be integrated into a routine health check. The diabetes risk prediction model contains modifiable non-invasive risk factors and consists of eleven questions on age, height, waist circumference, hypertension, physical activity, smoking status, intake of whole-grain bread, intake of red meat, coffee consumption, and family history of diabetes (parents and siblings) to predict the five-year diabetes risk. The filled diabetes risk score will be used in the counseling interview with the PCP at the end of the health check as a practical guide to discuss individual tailored preventive strategies.
15953907|NCT03234309|Drug|Ferumoxytol|Given IV
15953908|NCT03234309|Procedure|Magnetic Resonance Imaging|Undergo MRI
15953909|NCT03234296|Drug|Ertapenem|Intravenous antibiotic followed by per oral antibiotics
15953911|NCT03234283|Device|IRRIS InfraRed - Red Intubation System|IRRIS will be attached to the patient's neck skin just beneath the laryngeal prominence. Tracheal intubation will be performed by using a video-laryngoscope in a standardized Fashion and by guiding the tracheal tube into the Larynx by following the visual Signal on the Screen that is caused by IRRIS. The handling of IRRIS and the Performance of tracheal Intubation will be recorded. Patients will be monitored for safety parameters and possible adverse events during the study until recovered and released from the postoperative care unit.
15953912|NCT03234270|Device|Core temperature measurements|Core temperature measurements with coretemp pill
15953913|NCT03234257|Device|UF-ultrasound|the carotid plaque stability by UF in order to improve the stroke prediction in case of asymptomatic stenosis. A UF-ultrasound approach is a non-irradiating, easily accessible, and low cost technique
15953914|NCT03234244|Drug|Bazedoxifene 20 mg|To estimate the drug-drug interaction between Bazedoxifene and combination of Bazedoxifene and Cholecalciferol, Subject will take Bazedoxifene 20mg 1 tablet one time.
15953915|NCT03234244|Drug|Cholecalciferol|To estimate the drug-drug interaction between Cholecalciferol and combination of Bazedoxifene and Cholecalciferol, Subject will take Cholecalciferol 2 tablets one time.
15953916|NCT03234244|Drug|Bazedoxifene 20mg and Cholecalciferol|For estimate the Drug-Drug Interaction, Subject will take Bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once.
15953917|NCT03234231|Behavioral|3-month supervised tooth brushing programme|One or a few dental hygienists, who are trained to teach how to brush and provide scaling, will supervise the students to brush daily in school for three months.
15953918|NCT03234231|Behavioral|oral health education talk|It is conducted by a dentist, while written materials will be delivered to the students and their carers.
15953919|NCT03234205|Device|MRI scan|"MRI standard protocol with addition of:
~a second clinical respiratory belt besides belt usually installed for clinical examination
~a second clinical electrocardiogram sensor besides sensor usually installed for clinical examination
~12 sequences during free respiration are added lasting supplementary 15 minutes
~Use of cardiac antennae usually used for cardiac MRI scans"
15953920|NCT03234192|Procedure|Therapeutic ultra sound|This group will receive standard treatment consisting of eccentric strengthening, stretch, proximal strengthening, and education in addition to therapeutic ultra sound treatment.
15953921|NCT03234192|Procedure|Astym Treatment Technique|This group will receive standard treatment consisting of eccentric strengthening, stretch, proximal strengthening, and education in addition to Astym Treatment.
15953922|NCT03234192|Procedure|Graston Treatment Technique|This group will receive standard treatment consisting of eccentric strengthening, stretch, proximal strengthening, and education in addition to Graston Treatment.
15953923|NCT03234166|Other|Non interventional study|Only data will be taken of patient's file.
15953924|NCT03234153|Drug|Durvalumab (Imfinzi)|Durvalumab 1500 mg i.v. every 4 weeks in combination with Tremelimumab 75 mg i.v. every 4 weeks for a total of 4 cycles before surgery.
15953925|NCT03234153|Drug|Tremelimumab|Tremelimumab 75 mg i.v. in combination with Durvalumab 1500 mg i.v. every 4 weeks every 4 weeks for a total of 4 cycles before surgery.
15953926|NCT03234140|Genetic|Genome Wide Association Studies|Using the Genome wide association studies (GWAS) approach on these 1,565 patients, the project plan to identify new prognostic markers. These markers will then be analyzed to decipher the impact of host genetics on somatic alterations and tumor biology, using public or matched patient data.
15953927|NCT03234140|Genetic|Single-nucleotide polymorphisms's genotyping|Analyze of the influence of single-nucleotide polymorphisms on circulating t(14;18) levels
15953928|NCT03234127|Genetic|Whole Genome Sequencing|Whole Genome Sequencing Biomarkers analyses
15953929|NCT03234114|Drug|Triple antithrombotic therapy|Including warfarin with targeted INR 2.0-3.0 (Shanghai Xinyi pharma co., LTD, China), aspirin 100 mg per day (Bayer, Germany) and clopidogrel 75 mg per day (Sanofi, France)
15953930|NCT03234114|Drug|Dual antithrombotc therapy|Including dabigatran 110 mg b.i.d. (Boehringer Ingelheim, Germany) plus ticagrelor 90 mg b.i.d. (AstraZeneca, Britain) or clopidogrel 75 mg per day (Sanofi, France)
15953931|NCT03234101|Behavioral|Low-risk lifestyle behaviours|"Low-risk lifestyle behaviours defined as:
~1) Healthy body weight (Minimum: BMI <30kg/m2 or WC of <88 in females or <92 in males); 2) Healthy diet (healthy diet, diet score with higher fruits & vegetables to Mediterranean dietary pattern); 3) Regular physical activity (20 minutes ≥ 1 time/week ); 4) Smoking cessation (never smoked to smoking cessation >12 months); 5) Moderate alcohol intake (up to 30g/day); 6) Adequate sleep (>6 hours)"
15953932|NCT03234088|Behavioral|Daily weight measured by digital scale and symptom reporting|All subjects will be provided the intervention.
15953933|NCT03234075|Other|Regional organization for promotion of renal transplantation|"Early identification of candidates for renal transplantation
~with the help of a care coordinator Inform all patients appropriately about the techniques of renal function supplementation
~delivered by expert patients and a care coordinator Assist the nephrologists in patient graft pathway
~Multidisciplinary assessment of patients in dedicated web-conferencing meetings bringing together nephrologists and transplant team ( WebRCP of kidney transplant orientation)
~Helping to carry out the pre-graft assessments of patients by a care coordinator"
15953934|NCT03234062|Other|25% Cho diet|Subjects will consume meals containing 25% of the recommended intake of Choline (137.5 mg Choline/day) for 2 weeks. On day 12 of the diet period, subjects will consume 250 mg of Cho in the form of Cho chloride-(trimethyl-d9, 9%, Cambridge Isotope Laboratories, Tewksbury, Massachusetts, (USA), as a bolus.
15953935|NCT03234062|Other|50% Cho diet|Subjects will consume meals containing 50% of the recommended intake of Choline (275 mg Choline/day) for 2 weeks. On day 12 of the diet period, subjects will consume 250 mg of Cho in the form of Cho chloride-(trimethyl-d9, 9%, Cambridge Isotope Laboratories, Tewksbury, Massachusetts, (USA), as a bolus.
15953936|NCT03234062|Other|100% Cho diet|Subjects will consume meals containing 100% of the recommended intake of Choline (550 mg Choline/day) for 2 weeks. On day 12 of the diet period, subjects will consume 250 mg of Cho in the form of Cho chloride-(trimethyl-d9, 9%, Cambridge Isotope Laboratories, Tewksbury, Massachusetts, (USA), as a bolus.
15953937|NCT03234049|Other|Checklist|The Alberta Children's Hospital Trauma Checklist was developed by the ACH Resuscitation Council Trauma Committee in response to a quality assurance review of high-acuity trauma activations. It is a cognitive aid and focuses in particular on pre-arrival preparation and a pre-departure review prior to patient transfer to diagnostic imaging or the operating room.
15953938|NCT03234036|Drug|GSK2838232 100 mg tablet|It is a white to slightly colored tablet. It will be supplied as prefilled tablets in bulk for dispensing to subjects at the site according to the treatment code.
15953939|NCT03234036|Drug|GSK2838232 50 mg capsule|It is a pink unmarked capsule. It will be supplied as prefilled capsules in bulk for dispensing to subjects at the site according to the treatment code.
15953940|NCT03234036|Drug|Ritonavir 100 mg tablets|It is a white film-coated ovaloid tablets.
15953941|NCT03234036|Drug|Placebo for GSK2838232 tablets|It is a white to slightly colored tablet. The placebo tablets supplied will not be identical to GSK2838232 tablets. It will be administered by site staff via an opaque card or paper tube.
15953942|NCT03234023|Behavioral|INTERVENTION GROUP|Offer recommendations of healthy living habits and control of pharmacy administration
15953943|NCT03234010|Other|FT21092|An electronic cigarette
15953944|NCT03234010|Other|FT21093|An electronic cigarette
15953945|NCT03234010|Other|FT21096|An electronic cigarette
15953946|NCT03234010|Other|FT21097|An electronic cigarette
15953947|NCT03233997|Other|FT21018|An electronic cigarette
15953948|NCT03233997|Other|FT21033|An electronic cigarette
15953949|NCT03233997|Other|FT21034|An electronic cigarette
15953950|NCT03233997|Other|FT21035|An electronic cigarette
15953951|NCT03233984|Behavioral|"sensibilisation program Ma maison, mon environnement santé"|The aim of this program is to spread the awarness about endocrine disruptors through workshops and presentation.
15953952|NCT03233971|Other|rPATD Questionnaire|A 5-point Likert scale questionnaire consisting of 22 questions for older adults, and 19 questions of caregivers.
15953953|NCT03233958|Behavioral|Systemic / family constellation|Systemic / family constellation integrates elements from psychodrama, family sculpture, and spontaneous dramatizations of intra- and interpersonal processes, while spatially visualizing family dynamics. Family constellations stimulate change through the following ways: 1) making visible the spatial arrangement of relationships within a conflictual system; 2) providing access to the insights of unrelated third parties regarding the sensations, feelings, and thoughts they experienced while representing family members within the constellation; and 3) making observable (from the outside) and experienceable (from within) the transformation of the problem constellation into the solution constellation [Hunger, Weinhold, Bornhäuser, Link, & Schweitzer, 2015].
15953954|NCT03233932|Drug|LeuplinⓡInj|Investigational drug(=LeuplinⓡInj)is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.
15953955|NCT03233932|Drug|CKD-841|Investigational drug(=CDK-841) is prescribed single injection dose by subcutaneous to 6 of randomized subjects once.
15953956|NCT03233919|Device|comprehensive remote ischaemic conditioning|"comprehensive remote ischaemic conditioning will be induced using an automated RIC device: Per-RIC consists of 5 cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on a lower limb. The first inflation began immediately following randomization after admission. In case 5 cycles of RIC were not fully completed when the first balloon inflation or thrombus aspiration was ready to be performed, PCI was not to be delayed.
~Post-RIC consists of 5 cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on a lower limb immediately after PPCI.
~Delayed-RIC consists of 5 cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on a lower limb once daily on 2-28 days after MI."
15953957|NCT03233906|Dietary Supplement|Chia Seeds- Salvia Hispanica|Chia seed added-10% of kcals and a no-chia control diet. 10% will be calculated using the following formula: Harris-Benedict equation multiplied by the activity factor of 1.2, 1.375, and 1.55 depending on each participant's activity level based on the information provided on the initial screening form.
15953958|NCT03233893|Other|light activated calcium silicate|"for the first group light activated calcium silicate can be easily placed by a 20 second light cure and ability to be syringed directly on to the cavity preparation and restore the cavity by composite restoration.
~for the second group using light activated calcium hydroxide is placed by placing a disposable tip securely on to the syringe then light cure for 20 seconds depending on the light cure unit and restore the cavity with composite restoration."
15953959|NCT03233880|Drug|Azithromycin 1gm|Azithromicin 1 gm oral single dose
15953960|NCT03233880|Other|PLACEBO|placebo
15953961|NCT03233854|Biological|Chimeric Antigen Receptor T-Cell Therapy|Given CD19/CD22 CAR T cells IV
15953962|NCT03233854|Drug|Cyclophosphamide|Given IV
15953963|NCT03233854|Drug|Fludarabine Phosphate|Given IV
15953964|NCT03233854|Other|Laboratory Biomarker Analysis|Correlative studies
15953965|NCT03233854|Other|Questionnaire Administration|Ancillary studies
15953966|NCT03233828|Biological|Aldesleukin|500,000 IU in 0.1mL
15953967|NCT03233828|Other|Saline|0.1 mL of sterile saline solution (0.9% m/v)
15953968|NCT03233815|Drug|Propofol|Propofol anesthesia Dose: 4-6mg/kg/h
15953969|NCT03233815|Drug|Sevoflurane|Inhaled anesthesia with sevoflurane. Dose: 1-2.5 Minimum Alveolar Concentration(MAC)
15953970|NCT03233802|Behavioral|Individualized Assess & Treatment (IATP)|See previous description
15953971|NCT03233802|Behavioral|Packaged Cognitive-Behavioral (PCBT)|See previous description
15953972|NCT03233802|Behavioral|Case Management (CaseM)|See previous description
15953973|NCT03233789|Behavioral|neurologic rehabilitation|in-patient rehabilitation of neurologic disorders
15953974|NCT03233776|Drug|Anakinra|Subjects will be treated with a daily dose of anakinra, intravenously, starting on day -2, until day +12 (day 0 is day of SCT). Predefined doses are 100 mg , 200 mg and 300 mg.
15953975|NCT03233763|Procedure|Bone Marrow Aspirate|Diagnostic Bone Marrow aspirate
15953976|NCT03233750|Behavioral|Stress Inoculation Training|see description in arm/group descriptions
15953977|NCT03233750|Behavioral|Crisis Resource Management|During each scenario, facilitators identify performance gaps in either situation awareness, leadership, communication or resource allocations. During debriefing session, these are raised with the learner and their cognitive frames are identified and corrected as necessary.
15953978|NCT03233737|Combination Product|One spray CTY-5339-A|Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredients: 14.0% Benzocaine (USP = 28 mg) and 2.0% Tetracaine Hydrochloride (USP = 4 mg). Administered in a single anesthetic spray.
15953979|NCT03233737|Device|One spray CTY-5339-CB|Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredient: 14.0% Benzocaine (USP = 28 mg). Administered in a single anesthetic spray.
15953980|NCT03233737|Device|One spray CTY-5339-P|Placebo. Metered spray bottle with ≈200 uL total spray volume. Contains no active ingredient (vehicle control).
15953984|NCT03233711|Biological|Nivolumab|Given IV
15953985|NCT03233711|Other|Patient Observation|Undergo observation
15953986|NCT03233685|Behavioral|Visual Training|The visual training will be performed 3 times a week for 40 minutes, at the end of warm up and before the technique training. The subjects will be performed a progression of exercise to improve their visual ability, their velocity of interpretation and transformation. The training will be performed with specific panels approved for visual training (S.V.T.A., Torino, Italy).
15953987|NCT03233685|Behavioral|Normal Training|Normal training routine
15953988|NCT03233672|Radiation|Hypo-fractionated postoperative IMRT-SIB|intensity-modulated radiation treatment with simultaneous integrated boost
15953989|NCT03233646|Device|Retinal Imaging|Non-invasive OCTA scan of retina
15953990|NCT03233633|Drug|Medical Marijuana|oral capsule, high ratio CBD:THC
15953991|NCT03233620|Other|Knee arthroplasty|Effectiveness of knee arthroplasty surgery.
15953992|NCT03233607|Procedure|Blood Draw|On postpartum day 1 and day 2, a sample of blood will be drawn in the morning for hemoglobin and hematocrit estimation.
15953993|NCT03233594|Other|Chiropractic Group|Participants will receive approximately 8 weeks of chiropractic care.
15953994|NCT03233594|Other|Healthy Control Group|Participants will not receive any interventions.
15953995|NCT03233581|Behavioral|Fitbit + Facebook + Coaching Group|Participants will use the FitBit device to track their physical activity (PA). Participants will receive and post messages and receive badges on the Facebook group. Weekly a research staff member will call them to provide brief health coaching. Participants will select an adult family member or friend to also receive a Fitbit during the intervention period to provide support.
15953996|NCT03233581|Behavioral|Fitbit only|Participants will receive a Fitbit device only, and will not receive health coaching, join the Facebook group, or select an adult family member or friend to receive a Fitbit to provide them with support.
15953997|NCT03233568|Diagnostic Test|Indirect calorimetry|"Indirect calorimetry will be performed by using an open-circuit calorimeter (Sensor Medics, Italy). Indirect calorimetry is the reference method for energy expenditure determination. A canopy hood covered the patient's head and expired air is extracted by a pump to be analyzed by metabolic cart sensors; flow rate is directly measured with a digital turbine flowmeter. After an overnight fast, patients will asked to lay supine in complete physical rest, not sleeping or talking for approximately 20-25 minutes, at a room temperature ranged between 22 and 24°C. The mean REE for each participant considers the last 15-20 minutes of measurements corresponding to steady state.
~Software of calorimeter will be set for minute-by-minute reading report of VO2 (Oxygen flow) and VCO2 (Carbon dioxide flow) measurement.
~Parameters obtained by Indirect Calorimetry will be the Resting Energy Expenditure and the Respiratory Quotient (RQ)"
15953998|NCT03233555|Other|Informational Intervention|Receive brochure
15953999|NCT03233555|Other|Internet-Based Intervention|Have access to EXCELS
15954000|NCT03233555|Other|Quality-of-Life Assessment|Ancillary studies
15954001|NCT03233555|Other|Questionnaire Administration|Ancillary studies
15954002|NCT03233555|Behavioral|Telephone-Based Intervention|Receive quarterly calls
15954003|NCT03233542|Behavioral|Cognitive Behaviour Therapy|Cognitive Behaviour Therapy (CBT) for diagnosed anxiety disorder (i.e. CBT for Panic Disorder in the Panic Disorder group, or other diagnosed anxiety disorders in the Anxious Control group.
15954004|NCT03233529|Drug|Crisaborole ointment 2% BID|Crisaborole ointment 2% BID for 15 days (double blind); additional 28 days (open label)
15954005|NCT03233529|Drug|Placebo ointment (vehicle)|Placebo ointment (vehicle) BID for 15 days (double blind)
15954006|NCT03233503|Diagnostic Test|Basic taste, fat sensation and texture perception|"This is an observational Sensory study methodologically similar to Astringency and bitterness perception clinicalTrials.gov identifier NCT03171402 Participants are first involved in sensory training sessions that train how they recognise between different basic tastes and differentiate perceived intensity in solutions and foods. After 6 months of training, the trained participants are involved in tasting a wide array of commonly consumed foods. At this study phase, participants will rate for the foods' taste, fat sensation perception and texture"
15954007|NCT03233490|Other|web course|Web course Help Brain Heart was conducted Before CPR training.
15954008|NCT03233490|Other|CPR training|No web course was conducted
15954009|NCT03233451|Behavioral|Psycho-behavioral intervention|The psycho-behavioral intervention included 12-week weekly guided psychological intervention (8 modules of behavioral intervention) and 24-week monthly maintenance psychological support.
15954010|NCT03233438|Drug|Dalbavancin|Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes.
15954011|NCT03233438|Drug|Usual Care|Usual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
15954012|NCT03233425|Behavioral|multiprofessional group therapy|Behavioural therapy of lifestyle including activity, family and eating habits
15954013|NCT03233412|Procedure|Control|Exertion of the cervix transformation zone
15954014|NCT03233412|Drug|Imiquimod|Application by the doctor of immunomodulatory cream on the uterine cervix 1 time per week for 12 weeks
15954015|NCT03233399|Device|Sham TMS3 stimulation|half of the subjects will receive sham stimulation first
15954016|NCT03233399|Device|rTMS of left or right angular gyrus (AG) or frontal cortex (FC)|Half of the subjects will receive active stimulation first; A subject may receive either TMS or tDCS stimulation, but not both, over the course of the sub-study.
15954017|NCT03233399|Device|Anodal tDCS of left or right AG or FC|Half of the subjects will receive active stimulation first; A subject may receive either TMS or tDCS stimulation, but not both, over the course of the sub-study.
15954018|NCT03233386|Behavioral|Mantente REAL|substance abuse prevention curriculum for adolescents
15954048|NCT03233230|Drug|M2951 50 mg BID|Participants received 50 mg of M2951 orally twice daily (BID) for 12 weeks.
15954019|NCT03233373|Device|Seek CompactPro thermal imager|A device with image/video recording capability, it is non-invasive and only relies on infrared emissions from heat sources (the patient).
15954020|NCT03233347|Drug|Brentuximab Vedotin|Given IV
15954021|NCT03233347|Drug|Dacarbazine|Given IV
15954022|NCT03233347|Drug|Doxorubicin|Given IV
15954023|NCT03233347|Other|Laboratory Biomarker Analysis|Correlative studies
15954024|NCT03233347|Biological|Nivolumab|Given IV
15954025|NCT03233347|Drug|Vinblastine|Given IV
15954026|NCT03233334|Behavioral|Purpose Project|The purpose project intervention 8-session group intervention that integrates education, support, self-reflection, and action-expectation to help people reaffirm or reconstruct self-grounded purpose after significant life events/transitions. The 8 sessions extend over 2-3 months, with 7 weekly sessions and the final session 1 month after Session 7. The intervention is structured around the 6 dimensions of flourishing (autonomy, self-acceptance, personal growth, relationships, purpose in life, external mastery), the goal of which is to help people enact behaviors that move them forward in reframing a sense of self and reaffirming or reconstructing a sense of purpose in life that helps them flourish.
15954027|NCT03233321|Other|Dry cold application|Dry cold application using ice bag (Crushed ice was filled in ice bag with ½ table spoon of salt and then covered by clean linen to prevent moisture) was placed over the injection site for about 20 minutes.
15954028|NCT03233321|Other|sub cutaneous injection (low molecular weight heparin)|sub cutaneous injection (low molecular weight heparin) has been administered on injection site
15954029|NCT03233308|Drug|Netarsudil Ophthalmic Solution 0.02%|1 drop daily (QD), in the morning (AM) Netarsudil Ophthalmic Solution 0.02% administered to one eye and Placebo comparator to the contralateral eye
15954030|NCT03233308|Other|Placebo Comparator|1 drop daily (QD), in the morning (AM) of Placebo comparator administered to one eye and Netarsudil Ophthalmic Solution 0.02% to the contralateral eye
15954031|NCT03233295|Drug|Vitamin D3 B.O.N. Injection|cholecalciferol 200,000IU
15954032|NCT03233282|Other|Electroencephalography (EEG) multi-sensor|Electrophysiological measurements of cerebral activity will be performed by multi-sensor electroencephalography (EEG), which is a non-invasive method.
15954033|NCT03233282|Other|Magnetoencephalography (MEG)|Electrophysiological measurements of brain activity will be performed by magnetoencephalography (MEG) which is a non-invasive method.
15954034|NCT03233282|Other|Behavioral Measures|The evaluation of cognitive performance will be carried out by means of behavioral measures, push-button type, handling of a mouse or a joystick.
15954035|NCT03233282|Other|Reaction time measurement|The assessment of cognitive performance will be carried out using standard behavioral measures, such as reaction time measurement.
15954036|NCT03233282|Other|Assessment of physical performance|The assessment of physical performance will be based both on bioenergetic measurements and on quantitative data collected in continuous and relative to the effort (eg instantaneous pedaling speed).
15954037|NCT03233282|Other|Electrooculogram (EOG)|In order to extract artifacts and verify the physical performances of the subjects, under the conditions of physical fatigability, peripheral electrophysiological recordings will be necessary and complementary to meet the objectives set in this study.
15954038|NCT03233282|Other|Electromyogram (EMG)|In order to extract artifacts and verify the physical performances of the subjects, under the conditions of physical fatigability, peripheral electrophysiological recordings will be necessary and complementary to meet the objectives set in this study.
15954039|NCT03233282|Other|Electrocardiogram with 3 leads|In order to extract artifacts and verify the physical performances of the subjects, under the conditions of physical fatigability, peripheral electrophysiological recordings will be necessary and complementary to meet the objectives set in this study.
15954040|NCT03233282|Other|Electrodermogram (EDG)|In order to extract artifacts and verify the physical performances of the subjects, under the conditions of physical fatigability, peripheral electrophysiological recordings will be necessary and complementary to meet the objectives set in this study.
15954041|NCT03233282|Other|Consumption of O2 (VO2)|In order to extract artifacts and verify the physical performances of the subjects, under the conditions of physical fatigability, peripheral electrophysiological recordings will be necessary and complementary to meet the objectives set in this study.
15954042|NCT03233282|Other|Production of CO2 (VCO2)|In order to extract artifacts and verify the physical performances of the subjects, under the conditions of physical fatigability, peripheral electrophysiological recordings will be necessary and complementary to meet the objectives set in this study.
15954043|NCT03233269|Behavioral|Music Therapy|During the educational music therapy intervention, member(s) of the Adult Sickle Cell Disease team will share with the patients the medical information pertinent to the appointment via a prerecorded video. The Music Therapist will then engage the patients in a music therapy intervention designed to teach and reinforce the skills and knowledge presented. These music therapy interventions may include but are not limited to original songs/rap/instrumental playing, vocal and/or instrumental improvisation, patient-contributed lyrics, mnemonics, and stress and pain reducing strategies. The music therapy interventions will be tailored to best convey the educational message.
15954044|NCT03233256|Procedure|Feasibility of measuring 2H:1H and 18O:16O in saliva and breath.|The investigators propose to demonstrate the feasibility of measuring 2H:1H and 18O:16O in saliva and breath. The natural abundances of 2H:1H and 18O:16O of urine, saliva, and breath samples will be determined from samples obtained simultaneously from 50 relatively healthy human subjects. We will also measure 2H:1H and 18O:16O enrichments in urine, saliva, and breath of 10 relatively healthy human subjects obtained after consuming a standard DLW dose and compare the estimates of TDEE using these different matrices.
15954045|NCT03233243|Drug|Rosuvastatin Oral Tablet|Patients with 18F-NaF-positive plaques will be treated with 20 mg of rosuvastatin daily for six months, except in patients who need a 55% LDL reduction to achieve recommended targets (rosuvastatin 40 mg). A second visit (visit 2) will take place eight weeks after therapy initiation to monitor for compliance and adverse events report: therapy will be discontinued if there is an elevation of creatine kinase over five times the ULN with myalgia or alanine amino-transferase three times the ULN.
15954046|NCT03233230|Drug|M2591 25 mg QD|Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 12 weeks.
15954047|NCT03233230|Drug|M2951 75 mg QD|Participants received 75 mg of M2951 orally QD for 12 weeks.
15989296|NCT02968732|Procedure|Radical Cystectomy|
15954051|NCT03233217|Biological|QIV-SD by SC|SC, injected into the upper arm (posterior region)
15954052|NCT03233217|Biological|QIV-HD by SC|SC, injection into the upper arm (posterior region)
15954057|NCT03233178|Other|Non-interventional|
15954058|NCT03233165|Procedure|Er:YAG laser|"Ablation of the lesions Device: Er:YAG laser (LightWalker AT, Fotona, Slovenia, 2013) with a non-contact X-Runner digitally controled hand-piece.
~Settings for the Er:YAG laser were as follows: pulse mode was Quantum Square Pulse (QSP), pulse energy of 120mJ, frequency of 20Hz and water sprey level was set to10ml per minute."
15954059|NCT03233165|Procedure|Er,Cr:YSGG laser|Ablation of the lesions Device: Er,Cr:YSGG laser(WaterLase iPlus, Biolase LTD, USA) using contact mode. Settings were subsequent: power 50W, frequency 50Hz and concentration ratio of air and water was 2:4.
15954060|NCT03233152|Drug|Ipilimumab (YervoyTM, 50 mg/10 mL solution)|"Ipilimumab will be administered by at the end of the neurosurgical resection procedure at a dose of injection of 10 mg (: 2 ml of YervoyTM, 50 mg/10mL vial).
~Injections will be performed manually using a 100 μ-liter dispensing syringe. Twenty needle tracks will dispense the ipilimumab solution within the brain tissue lining the resection cavity. The region suspect on preoperative MRI of the brain to be invaded by glioblastoma cells but not amenable to safe resection will be targeted by adjacent needle tracks through which up to 2 cm of depth a volume of 100 μl per needle track will be injected (: in total 20 needle tracks will be performed). This methodology has been applied previously within the context of phase III clinical trials with sitimagene ceradenovec."
15954061|NCT03233152|Drug|Nivolumab (OpdivoTM, 40 mg/4mL solution)|First administration of 10 mg of nivolumab by the intravenous route should be administered within 24 hours prior to the planned neurosurgical resection. Administrations of 10 mg nivolumab (OpdivoTM, 40 mg/4mL solution) will be by a 15 minutes intravenous infusion on days 15, 29, 43, 57, and 71 (or up to ± 3 days before or after the scheduled date if necessary).
15954062|NCT03233139|Drug|REGN2810|Patients will be administered REGN2810 as per protocol
15954063|NCT03233139|Drug|Ipilimumab|To be administered per protocol
15954064|NCT03233139|Drug|Platinum-doublet chemotherapy|To be administered per protocol
15954065|NCT03233126|Drug|KRN23|Subjects will receive subcutaneous injections of KRN23 every 2 weeks from Week 0 through Week 86
15954066|NCT03233113|Behavioral|Exposure therapy|"Exposure therapy (i.e., exposure-based cognitive behavioral therapy) for spider phobia according to condition-specific, scripted treatment manuals inspired by evidence-based exposure programs for anxiety/phobias (for both arms: Abramowitz, Deacon, & Whiteside, 20011; Antony, Craske, & Barlow, 1995) as well as the seminal account of the judicious use of safety behaviors thesis (for the experimental arm only: Rachman, Radomsky, & Shafran, 2008). Exposure and response prevention involves confronting a live spider while resisting safety-seeking behaviors; exposure with judicious safety behaviors involves strategically using safety behaviors while confronting a live spider."
15954067|NCT03233100|Other|FMT|fecal microbiota transplantation
15954068|NCT03233074|Other|Bone marrow analyses|This is a non-interventional study for the constitution of a biobank of bone marrows, in order to further investigate in vitro the cellular properties of bone marrow-isolated mesenchymal stromal cells.
15954069|NCT03233061|Diagnostic Test|cardiorespiratory fitness and daily physical activities evaluations|"The cardiopulmonary exercise testing is performed on a cycle ergometer connected to cardiovascular and respiratory software. Subjects have a facemask, which collected respiratory and metabolic variables.An incremental exercise test is performed up to exhaustion. ⩒O2 is recorded and heart rate is averaged by an electrocardiogram system.
~Cardiopulmonary exercise testing during household activities Subjects have to perform 3 everyday life household activities: ironing,cleaning floor,walking and climbing stairs.A wearable ambulatory indirect metabolic system is used with Holter mode to record cardiorespiratory measures.Subjects have to breathe through the K4b2 facemask and turbine."
15954070|NCT03233048|Device|ORBERA™ Intragastric Balloon|The balloon will be inserted into the stomach and inflated, and will remain in place for 6 months, after which the device will be removed.
15954071|NCT03233035|Drug|Ketamine|25mg of ketamine in 0.5 ml of serum saline in one pulverisation per nostril is received
15954072|NCT03233035|Drug|Placebo|0.5 mL of normal saline solution as a placebo in one pulverisation per nostril
15954073|NCT03233022|Behavioral|Happify|An online platform for conveying techniques from positive psychology, cognitive-behavioral therapy, and mindfulness-based stress reduction.
15954074|NCT03233009|Other|Experimental Daily Defense Serum A|Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).
15954075|NCT03233009|Other|Experimental Daily Defense Serum C|Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).
15954076|NCT03233009|Other|Experimental Daily Defense Serum G|Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).
15954077|NCT03233009|Other|Experimental Daily Defense Serum N|Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).
15954078|NCT03233009|Other|Saline Solution Sodium Chloride|Participants will apply 0.02mL/cm2 of product topically via semi-occlusive patches onto dorsum (Scapular region).
15954079|NCT03232996|Other|Computer game based balance and walking rehabilitation for individuals with Parkinson's Disease|All the participants will take part in an 8 week (twice per week) computer game based exercise program for dual task balance and dual task walk training. Participants will be standing in front of LED monitor. They will be asked to wear a head band which will be instrumented with motion sense mouse. Thus, hands-free head rotations will be used to interact with the computer games selected for the DT rehabilitation program. Participants will play few interactive computer games during - Normal standing (fixed surface), Standing on a compliant sponge pad and then while walking on a treadmill.
15954080|NCT03232983|Drug|LY900014 (SC)|Administered SC
15954081|NCT03232983|Drug|LY900014 (IV)|Administered IV
15954082|NCT03232970|Other|Full Plate Diet|12 weekly sessions on how to incorporate more fiber in the diet.
15954083|NCT03232957|Procedure|50 ug IT morphine|Spinal block with bupivacaine and intrathecal morphine 50 ug
15954084|NCT03232957|Procedure|100 ug IT morphine|Spinal block with bupivacaine and intrathecal morphine 100 ug
15954085|NCT03232957|Procedure|No IT morphine|Spinal block with bupivacaine and intrathecal morphine 0 ug
15954086|NCT03232957|Drug|Morphine|intrathecal morphine
15954087|NCT03232957|Drug|Bupivacaine|0.5 isobaric bupivacaine
15954088|NCT03232944|Device|Cardiac Resynchronization Therapy - MPP|The multiple point pacing feature (MPP) is designed to allow pacing from 2 LV electrodes.
15954089|NCT03232931|Behavioral|Therapist skin-to-skin Care|"Skin-to-skin (STS) holding is part of the mulitsensory intervention where the therapist will wear a clean 100% cotton T-shirt with a clean hospital gown on top of the shirt and wrap the kangaroo positioner securely over the gown. A gauze square scented with parent's skin will be used to provide olfactory stimulation. Therapist STS sessions occur with simultaneous playing of mother's voice contingent on infant pacifier sucking."
15954090|NCT03232931|Device|Contingent parent's voice exposure|The Pacifier Activated Lullaby® (PAL®) device, is a digital music delivery system that integrates a sensor, a pacifier routinely used in the NICU, and a receiver. It delivers a predetermined 10 seconds of recorded parent's voice singing lullabies upon detection of a suck that meets a preset pressure threshold. The original systems were modified for research use by decreasing the lower limit of activation thresholds for delivering the recording. Minimal effort is required to trigger the device. However, the settings ensure that regular attempts are needed to continue to receive continual presentation of the recording of mother's voice by requiring another suck after 10 seconds. The auditory stimulation with PAL will be provided when the infants are still awake (i.e., at the beginning of the session).
15954091|NCT03232931|Behavioral|Parental skin-to-skin care|The standard of care includes parental skin-to-skin care and exposure to parent's voice. During parental skin-to-skin care, infants are placed in a prone position with head positioned over the sternum, allowing transmission of breath and heart sounds to the developing ear. Deeper pressure is applied to offer support and feedback to the child's bottom. Session length is set to a minimum of 45 minutes per unit protocols.
15954092|NCT03232931|Device|Recorded parent's voice|Per standard of care, preterm infants in the NICU currently receive noncontingent recorded parents' voice during two 20 minute sessions per day. Recordings are standardized and are played through a sterilizable device (DINO-egg).
15954093|NCT03232918|Drug|Half dose Oxytocin|Patients randomized to the half dose oxytocin group will have the oxytocin infusion reduced to 50 % prior to placement of combined spinal epidural for labor analgesia
15954094|NCT03232905|Drug|PF-06651600|PF-06651600 will be administered as tablet
15954095|NCT03232905|Drug|Placebo|Matching placebo will be administered as tablet
15954096|NCT03232892|Drug|Trametinib|Trametinib 2mg, once daily, PO, 28-day cycles
15954097|NCT03232879|Behavioral|Motor Imagery|Two consecutive 30 seconds imagery tasks were performed, both based on two movements that are recorded in the Revised Movement Imagery Questionnaire (MIQ-R).
15954098|NCT03232879|Behavioral|Action Observation|Two consecutive 30 seconds imagery tasks were performed, both based on two movements that are recorded in the Revised Movement Imagery Questionnaire (MIQ-R). Before the subjects performed the mental MI practice, they were presented with a 30 seconds video that displayed the task that they ought to imagine later. A video was played prior to the first practice of imagination and after the second mental practice, a second video was shown.
15954099|NCT03232866|Other|Pilates exercise|Pilates methods exercises
15954100|NCT03232853|Other|Elearning|Elearning
15954101|NCT03232827|Behavioral|Flavored-Sweetened Waterpipe Tobacco|Pre-weighed flavored-sweetened waterpipe tobacco will be prepared.
15954102|NCT03232827|Behavioral|Unflavored-sweetened waterpipe tobacco|Pre-weighed unflavored-sweetened waterpipe tobacco will be prepared.
15954103|NCT03232827|Behavioral|Unflavored-very low sweetened waterpipe tobacco|Pre-weighed unflavored-very low sweetened waterpipe tobacco will be prepared.
15954104|NCT03232827|Behavioral|Flavored-very low sweetened waterpipe|Pre-weighed flavored-very low sweetened waterpipe tobacco will be prepared.
15954105|NCT03232814|Behavioral|Group-based walking|The walking prescription will be progressive in nature. The program will begin with participants walking for approximately 20 minutes in weeks 1-3. This will gradually increase to approximately 30 minutes in weeks 4-6. Finally, this will increase to 45-60 minutes in weeks 7-8. The program will promote walking at a moderate intensity as assessed by Borg's Rating of Perceived Exertion scale. Each session will be preceded by a brief warm-up and followed by a brief cool-down period.
15954106|NCT03232801|Behavioral|mindfulness-based multicomponent intervention|A group-based, multicomponent behavioral intervention rooted in mindfulness
15954107|NCT03232801|Behavioral|general health education group|A general health and aging education group
15954108|NCT03232788|Procedure|Bone regeneration|Autogenous bone will be placed over periodontal defect after root treatment with scaling and root planing.
15954109|NCT03232788|Device|Collagen membrane|A collagen membrane will be used to cover the autogenous bone.
15954110|NCT03232788|Device|Scaffold|A hydroxyapatite and polycaprolactone scaffolds will be used to cover the autogenous bone.
15954111|NCT03232775|Other|Treatment: Physical Exam with Visual Pedagogy and Structure|Routine physical examination participants receive visual pedagogy and reinforcement (preferred food treat).
15954112|NCT03232775|Other|Control: Physical Exam without Visual Pedagogy and Structure|Participants engage in routine physical examination without visual pedagogy and reinforcement (preferred food treat).
15954113|NCT03232762|Dietary Supplement|Refined Grains|In week one each patient will have a text message or phone call to report on her diet and the information will be recorded as an attempt to assure compliance.
15954114|NCT03232762|Dietary Supplement|Whole Grains|In week one each patient will have a text message or phone call to report on her diet and the information will be recorded as an attempt to assure compliance.
15954115|NCT03232749|Procedure|intraarticular corticosteroid injections (IACSI)|ultrasound-guided IACSI will be administered
15954116|NCT03232749|Drug|corticosteroid injections|Corticosteroid will be administered is used to treat pain and swelling that occurs with arthritis and other joint disorder
15954117|NCT03232749|Device|Ultrasound|ultrasound-guided IACSI
15954187|NCT03232099|Dietary Supplement|Red Wine consumption|After a two weeks washout period,in the intervening period with red wine, patients will receive 250 mL / day of red wine per Day, 5 days a week, for 3 weeks.
15954118|NCT03232723|Diagnostic Test|Whole-cortex MEG System (with optional EEG)|"Whole-Cortex MEG System non- invasively measures the magnetoencephalographic (MEG) signals (and, optionally, electroencephalographic EEG signals) produced by electrically active tissue of the brain. These signals are recorded by a computerized data acquisition system, displayed, and may then be interpreted by trained physicians to help localize these active areas. The location may then be correlated with anatomical information of the brain. MEG is routinely used to identify the locations of visual, auditory, somatosensory, and motor cortex in the brain."
15954119|NCT03232710|Drug|Bosiqing|Aripiprazole Orally disintegrating tablets 10mg
15954120|NCT03232710|Drug|abilify|Aripiprazol orodispersible tablets 10mg
15954121|NCT03232697|Diagnostic Test|Full version of the Montreal Cognitive Assessment|Patients or subjects will be submitted to the full version of the MOCA
15954122|NCT03232697|Diagnostic Test|5 minutes version of the Montreal Cognitive Assessment|The same patients and subjects will be submitted to the 5 minutes version of the MOCA through a phone call
15954123|NCT03232684|Diagnostic Test|Rapid on-site evaluation|On-site (endoscopy suite) evaluation, by a pathologist or a pulmonologist, of specimens retrieved from intrathoracic lymph nodes during EBUS-TBNA
15954124|NCT03232671|Diagnostic Test|MIF ELISA|Blood sample
15954125|NCT03232645|Device|Ablation procedure|Cathater ablation of pulmonary veins with the Rhythmia HDx mapping system, IntellaMap Orion mapping catheter and IntellaNav Mifi OI ablation catheter
15954126|NCT03232632|Drug|PET with 18 F-Flutemetamol|PET with 18 F-Flutemetamol (Vizamyl ®)
15954127|NCT03232619|Biological|CD19 CART|Patients will get one course of CART treatment with the dose of 0.5-5*10~6/KgBW.
15954128|NCT03232593|Drug|Atezolizumab|Participants will receive atezolizumab as per the local label and standard of care at physician's discretion.
15954129|NCT03232580|Drug|rhAnnexin V-128|All patients received a single i.v injection of 99mTc-rhAnnexin V-128 at Day 0.
15954130|NCT03232567|Biological|NasoVAX|Single ascending dose study
15954131|NCT03232554|Drug|Buxue Yimu Pills|Buxue Yimu Pills 12g pill by mouth, twice daily.
15954132|NCT03232554|Drug|Buxue Yimu Pills &Ferrous Sulfate|Buxue Yimu Pills 12g pill by mouth, twice daily and Ferrous Sulfate 0.3g tablet by mouth, three times daily
15954133|NCT03232554|Drug|Ferrous Sulfate|Ferrous Sulfate 0.3g tablet by mouth, three times daily
15954134|NCT03232541|Other|Standard care|A) Ordinary nausea treatment means receiving ordinary antiemetic medications. Within the group, the patients will be randomized to two communication types: 1) neutral communication or 2) strengthened positive communication regarding expected antiemetic effects of their treatment, using a standardized communication model.
15954135|NCT03232541|Device|Sham acupuncture|"B) Sham acupuncture is administered bilaterally to a non-acupuncture point two body-inches proximal and one body-inch radial from PC6 using the telescopic Park Sham Device. The sham-needle is blunt and glides upward into its handle instead of penetrating. Marking tubes hold the needle in place. The therapist gives an illusion of manipulating the needle by turning it three times until it touches the skin, but no specific needle sensation (deqi) will occur. Within the group, the patients will be randomized to two communication types: 1) neutral communication or 2) strengthened positive communication regarding expected antiemetic effects of their treatment, using a standardized communication model."
15954136|NCT03232541|Device|Genuine acupuncture|C) Acupuncture will be administered bilaterally to the standard antiemetic point PC6 located two body-inches proximal of the wrist crease, between the tendons of palmaris longus and flexor carpi radialis. Sharp acupuncture needles will be inserted into a depth of a half body-inch. The needles will be manipulated three times (at the start, middle and end of the treatment session) by twirling and lifting until deqi occurres. Within the group, the patients will be randomized to two communication types: 1) neutral communication or 2) strengthened positive communication regarding expected antiemetic effects of their treatment, using a standardized communication model.
15954137|NCT03232528|Other|Herb-partitioned moxibustion|Patients receive herb-partition moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks.
15954138|NCT03232528|Other|Sham herb-partitioned moxibustion|Patients receive sham herb-partition moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks.
15954139|NCT03232515|Combination Product|To estimate the dry weight of patients with chronic renal failure under hemodialysis treatment using BIVA|Using the BIVA method, excess fluid will be estimated in patients with chronic renal failure undergoing hemodialysis in order to obtain a better estimate of dry weight and thus improve the quality of life of patients.
15954140|NCT03232502|Diagnostic Test|Pharmacogenetic testing|Basic pharmacogenetic panel
15954141|NCT03232476|Device|Upper extremity voluntary loading|Subjects who are prescribed teriparatide by their healthcare provider may enroll in this study. The study intervention consists of loading one upper extremity. Subjects will be trained on how to perform the upper extremity exercises at home. Subjects will be expected to perform the exercises 3 days per week using one arm, with each session consisting of 100 loading cycles lasting a total of approximately 2 minutes each day.
15954142|NCT03232450|Drug|Aspirin|Subjects will receive 81 mg enteric coated aspirin
15954143|NCT03232450|Device|Cardiovascular Implantable Device (CIED)|All subjects will receive either a pacemaker, implantable cardioverter-defibrillator (ICD), or cardiac resynchronization therapy (CRT).
15954144|NCT03232450|Device|Gore Cardioform Septal Occluder|The Gore Cardioform Septal Occluder closes the patent foramen ovale (PFO).
15954145|NCT03232437|Device|Aina HbA1c Monitoring System|Monitoring test for quantitative determination of HbA1c
15954146|NCT03232424|Device|NovoTTF-200A|"Begins the day prior to radiotherapy start and continues until the end of temozolomide maintenance cycle #2 or until evidence of disease progression or unacceptable toxicity.
~Arrays are removed immediately prior to radiotherapy and replaced immediately thereafter."
15954147|NCT03232424|Drug|Temozolomide|"Concomitant phase:
~75 mg/m2 per day for 42 days concomitant with radiotherapy.
~Begins 1 day prior to XRT start.
~Maintenance phase:
~Begins 4 weeks after concomitant phase completion (+/- 1 week).
~Each cycle is 28 days (5 days of drug treatment followed by 23 days without).
~Cycle 1: 150 mg/m2 once daily for the first 5 days of each treatment cycle.
~Subsequent cycles: daily dose increased to 200 mg/m2, if the CTC non-hematologic toxicity for Cycle 1 is Grade ≤ 2 (except for alopecia, nausea and vomiting), absolute neutrophil count (ANC) is ≥ 1.5 x 109/L, and the platelet count is ≥ 100 x 109/L. The dose remains at 200 mg/m2 per day for the first 5 days of each subsequent cycle except if toxicity occurs."
15954148|NCT03232424|Radiation|3D conformal or intensity modulated radiation therapy (IMRT)|Radiotherapy will commence 4 weeks after the definitive surgical procedure (+/- 1 week), to a total dose of 54.0 - 60.0 Gy, delivered in 1.8 - 2.0 Gy fractions over 6 - 7 weeks. XRT target volumes will be determined utilizing all available imaging studies that best delineate extent of disease. Fusion image registration for treatment planning will be utilized as possible. Either 3D conformal or intensity modulated radiation therapy (IMRT) will be utilized.
15954149|NCT03232411|Other|Questionnaires|Participants will be asked to complete a baseline questionnaire that asks questions about their demographic information, medical history, and smoking habits when they first enroll in the study. They will also be asked to complete a follow-up questionnaire 2 years later. The questionnaires will each take about 25 minutes to complete.
15954150|NCT03232411|Other|Saliva Samples|Participants will be asked to provide a saliva sample using the saliva kit that will be mailed to them. Detailed instructions for collection will be included in the saliva collection packet.
15954151|NCT03232411|Other|Tumor Tissue|Participants will be asked for permission to obtain a sample of their tumor tissue. Participants will receive a medical release form. Once they complete it and mail it back, investigators will request a small amount of tissue collected during the participant's prostate biopsy (or during their surgery, if they had surgery) from their health care provider.
15954152|NCT03232398|Drug|Apixaban Oral Tablet [Eliquis]|Apixaban 5 mg BID for 3 months. Apixaban 2.5-mg BID doses will be used in a subset of patients with two or more of the following criteria: an age of at least 80 years, a body weight of no more than 60 kg, or a serum creatinine level of 1.5 mg per deciliter (133 μmol per liter) or more. Patients with advanced renal failure (CrCl between 15 ml/min and 29 mi/min) will also receive 2.5 mg BID.
15954153|NCT03232398|Drug|Warfarin|Dose-adjusted warfarin to achieve a target international normalized ratio (INR) of 2.0 to 3.0 for 3 months
15954154|NCT03232385|Device|MR-US Fusion Arm|Use of Clear Guide SCENERGY for MR-US fusion guidance
15954155|NCT03232385|Procedure|Renal Biopsy or Ablation|Standard of Care
15954156|NCT03232372|Device|External-Connection non-submerged Imp|Through a surgical procedure, we will implant implant whit external connection and non submerged to patients.
15954157|NCT03232372|Device|Internal Connection Submerged implants|Through a surgical procedure, we will implant implant whit internal connection and submerged to patients.
15954158|NCT03232372|Device|Internal Connection non-Submerged Impl|Through a surgical procedure, we will implant implant whit internal connection and non-submerged to patients.
15954159|NCT03232359|Diagnostic Test|immature platelets fraction|IPF-% and A-IPC using a reticulocyte detection channel CBC auto analyzer
15954160|NCT03232346|Drug|Vivitrol|Oral naltrexone induction procedure followed by Vivitrol
15954161|NCT03232346|Drug|Buprenorphine|5-week buprenorphine taper
15954162|NCT03232333|Device|Biologic wound graft|Diabetic foot ulcer will be treated by grafting with MIRODERM Biologic Wound Matrix
15954163|NCT03232320|Drug|Meditoxin|Meditoxin (Botulinum toxin type A)
15954164|NCT03232320|Drug|Placebo|Placebo (Normal saline)
15954165|NCT03232307|Drug|Dexamethasone|Given PO
15954166|NCT03232307|Drug|Ibrutinib|Given PO
15954167|NCT03232307|Drug|Lenalidomide|Given PO
15954168|NCT03232307|Biological|Rituximab|Given IV
15954169|NCT03232281|Drug|Triptorelin Pamoate PR 3-month|15mg/injection, administered as an intramuscular injection once every 12 weeks (a total of 2 injections).
15954170|NCT03232281|Drug|Triptorelin Acetate PR 1-month|3.75mg/injection, administered as an intramuscular injection once every 4 weeks (a total of 6 injections)
15954171|NCT03232268|Biological|HLA-mismatched microtransplantation|3 administrations of hematopoietic stem cells without immunosupression
15954172|NCT03232255|Other|Mouthrinse (IQP-OLP-101)|Rinse/gargle 10mL of Mouthrinse for 60 seconds after tooth brushing, twice a day.
15954173|NCT03232242|Diagnostic Test|Next-generation sequencing|To provide rapid etiological diagnosis of patients by means of next-generation sequencing.
15954174|NCT03232216|Dietary Supplement|Vitamin D3.|Vitamin D3 50.000 UI in each packet of powder for oral solution.
15954175|NCT03232216|Dietary Supplement|Placebo|Placebo of Vitamin D3 50.000 UI in each packet of powder for oral solution.
15954176|NCT03232203|Drug|STRIMVELIS|It is the Autologous cluster of differentiation (CD) 34+ enriched cell fraction that contains CD34+ cells transduced with retroviral vector that encodes for the human ADA complementary Deoxyribonucleic acid (cDNA) sequence. HCP who have previously referred a patient for STRIMVELIS treatment or a parent's/carer's child who previously received treatment with STRIMVELIS will be recruited to the study
15954177|NCT03232190|Other|Web Application|Parents receive a web application that offers information and support until the age of 2.
15954178|NCT03232177|Drug|Anagre Cap.|from 0.5mg twice a day to maximally increase total10mg in 8 weeks and maintain maximal tolerable dose to 104 weeks
15954179|NCT03232164|Drug|18F-DCFPyL PET|18F-DCFPyL PET demonstrates very high tumor-to-background and tumor specific uptake which may allow for a more sensitive and accurate method for detection of early tumor recurrence and metastatic disease as compared to current PET radiotracers and current standard-of-care imaging including 99mTc-methylene diphosphonate bone scintigraphy (bone scan), contrast-enhanced computed tomography (CT) and magnetic resonance imaging (MRI).
15954180|NCT03232151|Diagnostic Test|C-Arm Cone Beam Computed Tomography|C-ARM CBCT angiogram and CBCT perfusion imaging using prototype software (SMART-RECON) can rapidly and accurately assess the cerebral blood flow maps in the setting of decreased blood flow to the brain (ischemic cerebrovascular events). This rapid assessment would eliminate the need for the patient to be imaged in another scanner and be subsequently transported again to another room; all anatomic and physiologic imaging would occur in the angiography suite.
15954181|NCT03232138|Dietary Supplement|Sulforaphane|Sulforaphane (SF) is a naturally occurring substance (phytochemical) found in cruciferous vegetables.
15954182|NCT03232138|Drug|Placebo|Inactive ingredients
15954183|NCT03232125|Drug|Ramosetron|Randomly selected patients of the ramoseton group are given a 0.3 mg of ramosetron after induction.
15954184|NCT03232125|Drug|Normal saline|In contrast, patients in the control group are given the same volume of normal saline after induction and given a 0.3 mg of ramosetron after measurement of QTc interval.
15954185|NCT03232112|Drug|Exenatide 2 MG Injection|Subcutaneous injection once-weekly
15954186|NCT03232112|Drug|BD PosiFlush (saline)|Subcutaneous injection once-weekly
15954188|NCT03232099|Other|Period without alcohol consumption|After a two weeks washout period,in the Abstemious period, patients should not consume any kind of alcohol beverages, for 3 weeks
15954189|NCT03232086|Other|Clean Air|Each subject will be exposed to clean air for 4 hours. Subjects will exercise on a bike or treadmill. Each exercise session will consist of a 15 minute exercise interval at a level of up to 25 L/min/m2BSA followed by a 15 minute rest period.
15954190|NCT03232086|Other|PM2.5|Each subject will be exposed up to 35-50 μg/m3 PM2.5 for 4 hours. Subjects will exercise on a bike or treadmill. Each exercise session will consist of a 15 minute exercise interval at a level of up to 25 L/min/m2BSA followed by a 15 minute rest period.
15954192|NCT03232047|Device|Combined executive function and memory training|Computerized combined executive function and memory training
15954193|NCT03232034|Dietary Supplement|Calcium Citrate|1000 mg calcium as calcium citrate
15954194|NCT03232034|Dietary Supplement|Milk Mineral Supplement|Milk Minerals containing 1000 mg calcium
15954195|NCT03232034|Dietary Supplement|Whey Protein Hydrolysate|50 g whey protein hydrolysate
15954196|NCT03232021|Drug|Placebo oral capsule|Placebo oral capsule administered 1 hour prior to the surgical operation
15954197|NCT03232021|Drug|Pregabalin Oral Capsule [Lyrica] 75mg|Pregabalin Oral Capsule [Lyrica] 75 mg administered 1 hour prior to the surgical operation
15954198|NCT03232021|Drug|Pregabalin Oral Capsule [Lyrica] 150 mg|Pregabalin Oral Capsule [Lyrica] 150 mg administered 1 hour prior to the surgical operation
15954199|NCT03232008|Dietary Supplement|Canderel drink|1.4% aspartame and 0.95% acesulfame-k and 95% maltodextrin; 3g dissolved in 250ml of water
15954200|NCT03232008|Dietary Supplement|Canderel+Lyle's Golden Syrup drink|Canderel: 1.4% aspartame and 0.95% acesulfame-k and 95% maltodextrin; 3g dissolved in 250ml of water Lyle's Golden Syrup: 35 g (27g of glucose and fructose)
15954201|NCT03231995|Biological|Collection of nasopharyngeal specimen collected at D0, D1, D2 and D5.|"Analyses will be performed on nasopharyngeal specimen collected at D0, D1, D2 and D5.
~Definition and validation of nasopharyngeal microbiome biomarkers (bacterial, viral, transcriptomic signature)"
15954202|NCT03231982|Drug|Group I|Machkhan Tab. 8/5 mg + Atacan Tab. 8 mg placebo + Norvasc Tab. 5 mg placebo for 8 weeks or Machkhan Tab. 16/5 mg + Atacan Tab. 16 mg placebo + Norvasc Tab. 5 mg placebo for 8 weeks
15954203|NCT03231982|Drug|Group II|Atacan Tab. 8 mg + Norvasc Tab. 5 mg + Machkhan Tab.8/5 mg placebo for 8 weeks or Atacan Tab. 16 mg + Norvasc Tab. 5 mg + Machkhan Tab.16/5 mg placebo for 8 weeks
15954204|NCT03231969|Drug|Bilastine 0.2%|1 drop in each eye at 3 separate times during a 25 day period.
15954205|NCT03231969|Drug|Bilastine 0.4%|1 drop in each eye at 3 separate times during a 25 day period.
15954206|NCT03231969|Drug|Bilastine 0.6%|1 drop in each eye at 3 separate times during a 25 day period.
15954207|NCT03231969|Drug|Bilastine 0%|1 drop in each eye at 3 separate times during a 25 day period.
15954208|NCT03231956|Device|ClearSight™ / EV1000NI Clinical Platform|Noninvasive Hemodynamic Monitoring utilizing ClearSight TM System
15954209|NCT03231943|Drug|GSK3640254|GSK3640254 is a capsule available in 1 milligram (mg), 10 mg and 100 mg dosing strength. GSK3640254 capsule will be given via oral route during each dosing day with approximately 240 mL of water.
15954210|NCT03231943|Drug|Placebo|Placebo capsule matching to the study treatment will be given via oral route during each dosing day with approximately 240 mL of water.
15954211|NCT03231930|Device|OraQuick HCV Ab test|The OraQuick HCV point of care test involves the collection of oral fluid and provides an accurate result in approximately 20 minutes. The test involves a clinic nurse or community health worker providing pre-test counselling, then providing an oral swab to study participants, then reading the result and counselling the participant about their HCV antibody test result.
15954212|NCT03231930|Device|Xpert HCV viral load test|"The Cepheid Xpert HCV RNA test (Xpert® HCV Viral Load test) is a reverse transcriptase polymerase-based chain reaction amplification technology (RT-PCR) and provides an accurate HCV RNA load within 2 hours (105 minutes), using a serum sample.
~This test will be performed for participants who have a positive OraQuick HCV antibody result."
15954213|NCT03231917|Procedure|Water Infusion first|In this group patients will receive a colonoscopy with water infusion for mucosal inspection and then receive a colonoscopy with CO2 insufflation.
15954214|NCT03231917|Procedure|CO2 Insufflation First|In this group patients will receive a colonoscopy with CO2 insufflation for mucosal inspection and then receive a colonoscopy with water infusion .
15954215|NCT03231904|Diagnostic Test|Blood test|blood samples will be taken for maternal and fetal levels of ACTH and LIF
15954216|NCT03231878|Drug|MIN-102|MIN-102 treatment
15954217|NCT03231878|Drug|Placebos|Placebo
15954218|NCT03231865|Diagnostic Test|Non-invasive measurement of ZincProtoporphyrin IX|Within 30 seconds, a measurement is performed on the lip of a patient to determine a ZincProtoporphyrin value
15954219|NCT03231852|Other|Survey|Attitudes and Randomized Trial Questionnaire (ARTQ), Hospital Anxiety and Depression Scale, Perception Survey
15954220|NCT03231839|Behavioral|Caloric restriction|After the baseline measurements individuals underwent dietary counseling and had 6 sessions with a dietician (after, 1,4,8,12 16 and 20 weeks).
15954221|NCT03231839|Behavioral|no red meat|After the baseline measurements individuals underwent dietary counseling and had 6 sessions with a dietician (after, 1,4,8,12 16 and 20 weeks).
15954222|NCT03231839|Behavioral|Increased fiber intake|After the baseline measurements individuals underwent dietary counseling and had 6 sessions with a dietician (after, 1,4,8,12 16 and 20 weeks).
15954223|NCT03231813|Procedure|Sodium lauryl sulphate induced irritation|Sodium lauryl sulphate will be applied to specified skin sites according to randomization protocol to induce irritation. 60 uL of 2% w/v SLS will be applied to skin under occlusion by large Finn chamber for 24 hours as described in the guidelines by Standardization group of European Society of Contact Dermatitis.
15954224|NCT03231813|Other|Emollient, moisturizing cream|Commercially available topical emollient cream will be applied by each participant to treatment sites according to randomization protocol.
15954225|NCT03231800|Drug|dasotraline|dasotraline 2mg capsule once daily
15954226|NCT03231800|Drug|Placebo|Placebo capsule once daily
15954227|NCT03231787|Diagnostic Test|Platelet function assay|"Plateletworks is an in vitro diagnostic screening assay for the determination of % platelet aggregation or % platelet inhibition.
~It will be used to measure platelet function after withdrawal of the antiplatelet agent.
~If there are more than 80,000 functional platelets, the patient will be operated on within the next 24 hours."
15954228|NCT03231761|Other|Service user testimonial videos|Service users describe their personal experiences receiving care for depression or psychosis and the impact of the treatment on their quality of life
15954229|NCT03231761|Other|mhGAP didactic video|Video with a narrated slide presentation describing diagnosis and treatment of depression and psychosis
15954232|NCT03231722|Drug|Panitumumab|6 mg/kg iv over 60 minutes, day 1
15954233|NCT03231722|Drug|Irinotecan|150 mg/sqm iv over 60 minutes day 1
15954234|NCT03231722|Drug|Oxaliplatin|85 mg/sqm iv over 2 hours day 1
15954235|NCT03231722|Drug|l-leucovorin|200 mg/sqm iv over 2 hours
15954236|NCT03231722|Drug|5-fluorouracil|400 mg/sqm iv bolus, day 1 followed by 2400 mg/sqm 48 h-continuous infusion, starting on day 1;
15954237|NCT03231709|Drug|Trelagliptin|Trelagliptin tablets
15954238|NCT03231709|Drug|Alogliptin|Alogliptin tablets
15954239|NCT03231683|Drug|Esketamine|intravenous S+ketamine 0.25 mg/kg (i.v. bolus) at the beginning and 0.25 mg/kg (i.v. bolus) 20 minutes before extubation along with remifentanil according to Minto model and propofol according to Marsh model
15954240|NCT03231683|Drug|Saline|intravenous normal saline (as placebo, with similar volume) at the beginning and 20 minutes before extubation along with remifentanil according to Minto model and propofol according to Schnider model
15954241|NCT03231683|Drug|Remifentanil|Either S+ketamine or saline at the beginning and 20 minutes before extubation along with remifentanil according to Minto model and propofol according to Schnider model
15954242|NCT03231683|Drug|Propofol|Either S+ketamine or saline at the beginning and 20 minutes before extubation along with remifentanil according to Minto model and propofol according to Schnider model
15954243|NCT03231670|Procedure|Blood sampling|5ml blood will be taken in addition to standard sampling
15954244|NCT03231657|Diagnostic Test|Placental biomarkers|sFlt1 and P1GF levels and sFlt1/PlGF ratio
15954245|NCT03231631|Behavioral|Education plan and adherence to exercise|"Send text messages with motivational sense at any time of the day, every 3 or 4 days.
~They will be given the option of performing directed exercise at the cardiac rehabilitation center.
~It will be recorded in an Excel table every time that text is sent to the patient.
~At the beginning and monthly, a brochure will be sent out explaining how physical activity is performed at home in case you can not walk.
~A monthly survey will be applied where the adherence to the exercise during the previous month is measured.
~These activities will be carried out for 12 weeks. At the end of week 12, patients will be referred to the cardiac rehabilitation unit in order to perform the aerobic capacity test again."
15954246|NCT03231618|Dietary Supplement|1. Low-fat and high-carbohydrate diet; 2. High-fat and low-carbohydrate diet; 3. High-protein and low-fat diet|Every participate was provided with 3 types of diets in random order
15954247|NCT03231605|Biological|Hepatitis A Vaccine|Vaccinating two Hepatitis A Vaccines separately in 18-24 months Children based on the grouping result .
15954248|NCT03231592|Other|CSA Group|Already included in the arm descriptions.
15954249|NCT03231592|Other|Enhanced Usual Care Group|Already included in the arm descriptions.
15954250|NCT03231579|Behavioral|Carevive CPS|This intervention will focus on the use of the Carevive CPS, enabling providers to deliver evidence-based and personalized treatment care plans to their CLL patients on/starting treatment. The Carevive CPS collects electronic patient reported outcomes (ePROs) and clinical data, reported and generated by clinical staff and/or peer-reviewed evidence, and includes patient education, resources, and referrals developed by cancer clinicians and researchers.
15954251|NCT03231566|Behavioral|Pain Neuroscience Education|See arm/group description
15954252|NCT03231553|Other|MiQuit text message support programme|MiQuit is an automated, responsive text message support programme lasting 12 weeks which sends texts containing self-help smoking cessation support and advice to participants mobile phones.
15954253|NCT03231540|Dietary Supplement|Whey protein supplement|Whey protein supplement to target protein intake of 1.5 g/kg/day
15954254|NCT03231527|Procedure|coronary artery bypass grafting (CABG)|myocardial revascularization
15954255|NCT03231514|Dietary Supplement|Carbohydrate Supplement (Carb10)|2 of 4 arms will be supplemented with carbohydrate pre-workout (Carb10, Compound Solutions, Carlsbad, CA)
15954256|NCT03231514|Other|Diet|2 groups will be on a carbohydrate-based diet (% energy from carbohydrate:fat:protein, 53:24:23) and 2 groups will be on a ketogenic diet (72:5:23)
15954257|NCT03231514|Other|Exercise|All groups will participate in a standardized exercise intervention.
15954258|NCT03231501|Drug|epitinib succinate|This is a single-arm open label study. A subject would take 160 mg of the study medication (epitinib succinate) every day on a 28-day cycle, until he or she reaches disease progression or intolerability.
15954259|NCT03231488|Other|Mindfulness intervention|A 10 minute mindfulness of breath exercise
15954260|NCT03231488|Other|Control intervention (unfocused attention)|A 10 minute unfocused attention intervention - participants are asked to let their mind wander on anything that comes to mind.
15954261|NCT03231475|Drug|SPH1188-11|qd.po
15954262|NCT03231449|Other|observation of current care|The study FEVRIER (survey of hospitalizations in cardiology units in sub-Saharan Africa) aims to establish a description of sub-Saharan standard of care, in order to get a cross sectional analysis (globally and per country) and a longitudinal analysis (evolution during 5 years).
15954263|NCT03231436|Drug|Fixed dose of 12.5mg bupivacaine|Spinal anesthesia performed with 12,5mg of bupivacaine with 25mcg fentanyl for cesarean section
15954264|NCT03231436|Drug|Height-adjusted dose of bupivacaine|Spinal anesthesia performed with height-adjusted dose of bupivacaine with 25mcg fentanyl for cesarean section
15954265|NCT03231423|Other|Drainage|Using drain after operation
15954266|NCT03231397|Drug|Assess AAA rupture risk by PET-CTA scans|Assess AAA rupture risk by PET-CTA scans
15954267|NCT03231397|Drug|18F-fludeoxyglucose (FDG)|Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging
15954268|NCT03231397|Diagnostic Test|11C-PBR28|Assess AAA rupture risk by PET-CTA scans using 18F-fludeoxyglucose (FDG)and 11C-PBR28 PET-CT and contrast-enhanced CTA imaging
15954269|NCT03231384|Device|Remote ischemic conditioning|"In this study, the remote ischemic conditioning treatment was composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which was induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation.
~Doctormate, IPC-906"
15954270|NCT03231371|Drug|Adenosine|Administration of intravenous adenosine infusion over 3 minutes (0.14 ml/kg, 3mg/ml concentration, total dose).
15954271|NCT03231358|Behavioral|Our Family Our Future|Our Family Our Future is a 'selective' behavioral prevention program, designed to address HIV/STI acquisition, sexual risk behavior, and depression among adolescents (ages 14-16) in communities with high HIV prevalence and from families where adolescents and parents already exhibit mild, potentially troublesome, depressive symptoms but do not reach the threshold for further screening for a significant clinical depressive disorder. This intervention involves parent-child dyads who receive the intervention in a community setting, in a facilitated group format. The intervention is comprised of 3-hour sessions, held weekly for 3 consecutive weeks with an individual family meeting in the third or fourth week depending on family desires.
15954272|NCT03231345|Procedure|US guided IJ|IV catheter placement
15954273|NCT03231345|Device|Ultrasound|Ultrasound-guided Internal Jugular vein
15954274|NCT03231332|Other|Microbiome Diversity detection|detection of microbiome composition and detection of specific mutations in genes conferring resistance to antibiotics
15954275|NCT03231319|Procedure|Fascia iliaca compartment block with IV-PCA|1. Fascia iliaca compartment block: The injection was performed under ultrasound guidance. Surface landmark is identified on the line between anterior superior iliac spine and pubic tubercle. The injection site is at the medial one-third of the line. The needle is threaded medial to lateral and standardization of local anesthetic deposit is in the fascia plane between fascia iliaca and iliacus muscle. Anesthetic regimen: 2% xylocaine 15mL + 0.5% bupivacaine 15mL.
15954276|NCT03231319|Procedure|Femoral nerve block and lateral femoral cutaneous nerve with IV-PCA|"Femoral nerve block: The injection was performed under ultrasound guidance. Femoral nerve was identified in the femoral neurovascular bundle below or around inguinal ligament. The needle is threaded with lateral to medial approach. Local anesthetics will be deposited around the femoral nerve, the standardization of protocol is that femoral nerve should be lifted off from iliacus muscle. Anesthetic regimen: 2% xylocaine 10mL + 0.5% bupivacaine 10mL.
~Lateral femoral cutaneous nerve block: The injection was performed under ultrasound guidance. Lateral femoral cutaneous nerve was identified in the fascia plane between sartorius muscle and tensor fascia lata muscle. Anesthetic regimen: 2% xylocaine 5mL + 0.5% bupivacaine 5mL"
15954277|NCT03231319|Procedure|IV-PCA|IV-PCA was programmed and provided to the patient for optimize pain control
15954278|NCT03231306|Drug|Binimetinib|Adult subjects (18 years and older) will receive binimetinib by mouth twice daily of 45mg/dose. Pediatric subjects (1-17 years of age) are being treated on the pediatric MTD established by a phase I study (NCT02285439).
15954279|NCT03231280|Device|SB-061|delivered via intra-articular injection
15954280|NCT03231280|Other|Placebo|Placebo delivered via intra-articular injection
15954281|NCT03231254|Device|Remotely Controlled Mandibular Positioner (RCMP)|RCMP device can accurately identify patients who are likely to be successful OA candidates. With a temporary dental appliance connected to a RCMP, the mandible could be progressively, mildly and precisely protruded in only anterior-posterior dimension, under the monitor of PSG, without disturbing sleep, until obstructive apneas and hypopneas were eliminated, particularly in REM sleep while supine. Besides, RCMP device can also determine the optimal therapeutic level of mandibular protrusion during sleep.
15954282|NCT03231228|Drug|Cefazolin 1 g Infusion|1 g cefazolin infusion for pediatric surgical subjects weighing ≥25 to <60 kg
15954283|NCT03231228|Drug|Cefazolin 2 g Infusion|2 g cefazolin infusion for pediatric surgical subjects weighing at least 60 kg
15954284|NCT03231215|Drug|Dexamethasone|dexamethasone + plain Bupivacaine injected epidurally.
15954285|NCT03231202|Procedure|Embolization|"The intervention arm will perform SAE as a central embolization of the splenic artery.
~Additional peripheral embolization is left to the discretion of the interventional radiologist."
15954286|NCT03231176|Drug|Varlitinib|oral tablets, twice daily
15954287|NCT03231176|Drug|Capecitabine|oral tablets, twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles
15954288|NCT03231163|Other|No Music|Participants lie supine on a table while no music is played.
15954289|NCT03231163|Other|Relaxing Classical Music|Participants lie supine on a table while classical music is played.
15954290|NCT03231163|Other|Self-Selected Relaxing Music|Participants lie supine on a table while self-selected relaxing music is played.
15954291|NCT03231150|Procedure|Local Steroid Injection into the plantar heel|Injections consisting of 0.5 ml 0.25% bupivacaine plain, 0.5 ml dexamethasone phosphate, and 0.5 ml triamcinolone acetonide 40 mg/ml.
15954292|NCT03231150|Procedure|Ultrasound Guided Injection|Execution of the USGI will employ an actual diagnostic US machine (Voluson E8 Expert, General Electric Company, Boston, MA) and a plantarmedial approach
15954293|NCT03231150|Procedure|Anatomical Guided injection|Execution of the ATGI will employ a sham diagnostic US machine and a plantarmedial approach.
15954294|NCT03231137|Combination Product|PRGF/ATV|Atorvastatin (ATV) loaded on plasma rich in growth factor (PRGF) Derived Fibrin Scaffold
15954295|NCT03231137|Drug|ATV gel|Atorvastatin gel
15954296|NCT03231137|Biological|PRF|Platelet rich fibrin
15954297|NCT03231137|Biological|PRGF|plasma rich in growth factor
15954298|NCT03231124|Drug|LEO 32731|LEO 32731 is being developed by LEO Pharma.
15954299|NCT03231124|Drug|Placebo|Placebo contains the same excipients in the same concentration, only lacking LEO 32731
15954300|NCT03231111|Other|Preventive Multimedia Teaching Program|Preventive Multimedia Teaching Program
15954301|NCT03231085|Drug|Ferrous fumarate or ferrostrane|Young children operated with craniosynostosis and treated with EPO and ferrous fumarate or ferostrane per os or intravenous ferric carboxymaltose.
15954302|NCT03231072|Device|Electrical Impedance Tomography record|Monitoring of pleural effusion evacuation by means of EIT
15954303|NCT03231046|Device|CBCT-US Fusion Arm|Use of Clear Guide SCENERGY for CBCT-US fusion guidance
15954304|NCT03231046|Procedure|Hepatic Biopsy or Ablation|Standard of Care
15954305|NCT03231033|Drug|Pioglitazone|Participants will receive three doses of Pioglitazone, 15 mg/day for 12 weeks, 30 mg/day for 12 weeks, and 45 mg/day for 12 weeks
15954306|NCT03231020|Other|Interview|"The proposed research study uses a comparative case study methodology, utilizing multiple sources of data to deeply examine 8-10 cases, each of which is defined as parent(s) of a child (< 5 years of age) with single ventricle disease who used the mHealth application. One group of cases (4-5) will have used the mHealth application less than recommended (non-adherent to the home monitoring recommendations) or declined to use the application and returned it before the end of the interstage period. The other group of comparison cases (4-5 cases) will have used the application as recommended by the clinical team (adherent) and continued doing so through the interstage period."
15954307|NCT03231007|Other|Questionnaire|A structured questionnaire will be administered to maternity service users. Another structured questionnaire will be administered to maternity healthcare professionals, and another to Organisational Leads (e.g. Clinical Directors at each site).
15954308|NCT03230981|Device|Optical imaging of the cornea in healthy subjects|OCT vibrography and Brillouin microscopy
15954309|NCT03230968|Behavioral|Integral Action Program for Respiration|
15954310|NCT03230955|Behavioral|Psychological and psycho-educational support by phone|The intervention is based on cognitive-behavioural therapy (CBT). The intervention, in order to achieve behavioural changes, will include components based in Bandura's social learning theory and social cognitive theory (Bandura, 1986) and the transtheorical model of change (Prochaska, 1992). It has been shown that expectations and self-efficacy are behavioural predictors and that they are an effective framework for the assistance to quit smoking. This theory allows evaluating patient motivation phase and adapting the interventions according to each phase (Fiore, 2011)
15954311|NCT03230955|Other|Brief counselling session|Brief counselling session
15954312|NCT03230942|Other|Pre-operative education|Verbal and booklet about symptoms and physical conditions pos knee replacement
15954313|NCT03230942|Other|Pos-operative rehabilitation|Physical therapy treatment
15954314|NCT03230929|Device|BIS-PLE|Anesthesiologist attaches the sensors of BIS and PLEM 100 on the forehead of the patient, and adheres the neuromuscular monitoring device on the medial side of the wrist and the ipsilateral thumb to continuously monitor the state of consciousness and muscle relaxation before, during and after surgery. Reversal of muscle relaxant could be performed by intravenous injection of sugammadex 4 mg/ kg in the case of deep neuromuscular relaxation, and 2 mg / kg in the case of shallow muscle relaxation degree under neuromuscular monitoring. After then, they monitor and record the values of BIS, PLEM 100, and neuromuscular monitoring in 1 minute increments for 5 minutes.
15954315|NCT03230916|Drug|IMI/REL FDC|IMI/REL is supplied as a single fixed dose combination (FDC) vial; which is administered at a maximum dose of 15 mg/kg IMI and 15 mg/kg CIL (up to 500 mg IMI and 500 mg CIL) and 7.5 mg/kg REL (up to 250 mg REL).
15954316|NCT03230903|Other|Home telerehabilitation|Patients will receive an individualized exercise plan sent to a computer at their home. Patients will have daily access to a physical therapist and exercise physiologist.
15954317|NCT03230903|Other|Usual Care|Patients will receive a written individualized exercise plan during their baseline visit on top of their usual disease care.
15954318|NCT03230890|Device|HIRREM|HIRREM is a closed-loop, allostatic, acoustic stimulation neurotechnology intended to support auto-calibration of neural oscillations. The core technology is commercially available as a technique for relaxation. Scalp sensors monitor brain frequencies and amplitudes, and in real time, software algorithms translate specific frequencies into audible tones of varying pitch. These are reflected via earbuds in as little as 4-8 milliseconds. The in-office intervention for this study is administered as a series of up to twenty four, typically 1.5-2 hours sessions, comprised of 4-10 protocols (some eyes open, some eyes closed), lasting 6-40 minutes each, working at different scalp locations. Sessions are received over 12 days. Two sessions can be done in a half day. The intervention is received while comfortably seated in a zero gravity chair.
15954319|NCT03230864|Drug|Lu AF35700|10 mg/day, encapsulated tablets, orally
15954320|NCT03230864|Drug|Risperidone|4-6 mg/day, encapsulated tablets, orally
15954321|NCT03230864|Drug|Olanzapine|15-20 mg/day, encapsulated tablets, orally
15954322|NCT03230851|Drug|aspirin 100mg/d therapy|100mg aspirin for at least 5 days followed by aspirin 100mg/d
15954323|NCT03230851|Drug|aspirin 100mg/2d therapy|100mg aspirin for at least 5 days followed by aspirin 100mg/2d
15954324|NCT03230851|Drug|aspirin 100mg/3d therapy|100mg aspirin for at least 5 days followed by aspirin 100mg/3d
15954325|NCT03230851|Drug|aspirin 50mg bid therapy|100mg aspirin for at least 5 days followed by aspirin 50mg bid
15954326|NCT03230851|Drug|aspirin 75mg/d therapy|100mg aspirin for at least 5 days followed by aspirin 75mg/d
15954327|NCT03230851|Drug|aspirin 50mg/d therapy|100mg aspirin for at least 5 days followed by aspirin 50mg/d
15954328|NCT03230851|Drug|indobufen 100mg bid therapy|100mg aspirin for at least 5 days followed by indobufen 100mg bid
15954329|NCT03230838|Drug|Ceftolozane|Ceftolozane 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for between 7 to 14 days
15954330|NCT03230838|Drug|Tazobactam|Tazobactam 10 mg/kg (maximum 0.5 g/dose) administered IV every 8 hours for between 7 to 14 days
15954331|NCT03230838|Drug|Meropenem|Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for between 7 to 14 days. At the investigator's discretion, some participants may receive meropenem up to 30 mg/kg.
15954332|NCT03230825|Drug|Oral contraceptive|Daily oral contraceptive agent for 3 weeks (FLAME, containing 0.02 mg Ethinylestradiol and 0.075 mg Gestodene)
15954333|NCT03230825|Other|Expectant management|No intervention and a follow up visit a wewk later
15954334|NCT03230812|Drug|Carnitene (L-Carnitine or Levocarnitine)|All subjects will undergo oral Carnitene (L-Carnitine or levocarnitine) supplementation for 96 days.The total dosage of L-carnitine per day will be 2970mg. Consumption of the chewing tablets will be divided over the day. Intake of these chewing tablets will be during breakfast (990mg), lunch (990mg) and during diner (990mg). Since the chewing tablets are only available in concentrations of 330mg, participants have to consume 3 chewing tablets per meal, a total of 9 chewing tablets each day.
15954395|NCT03230370|Other|LFT|The ELEP group receives additional daily 50 mins program focusing on training of the hemiplegic lower extremity.
15954335|NCT03230799|Procedure|minimal invasive lens surgery|We decreased the size of the capsulorhexis opening to 1.0-1.5 mm in diameter. Then we moved the location of the capsulorhexis to the peripheral area of the lens instead of the central area. A 0.9 mm phacoemulsification probe was used to remove the lens contents and/or cortical opacities.
15954336|NCT03230799|Procedure|traditional cataract surgery|ACCC+ I/A + PCCC + Anti-vit: anterior continuous capsulorhexis + irrigation/aspiration + posterior capsulorhexis + anterior vitrectomy
15954337|NCT03230786|Drug|Daily injection of KBP/placebo for 12 weeks as add-on to metformin|Daily subcutaneous injection
15954338|NCT03230773|Device|Defibrillator model|Comparison of the performance of different public access defibrillators
15954339|NCT03230760|Device|acupuncture|Device: acupuncture Acupuncture is the treatment which balances qi and blood by inserting needles into the acupoints of the meridians in human body.
15954340|NCT03230734|Drug|Radium-223|Radium-223: administered at the dose of 55 kBq per kg body weight, given at 4 week intervals for 6 injections, by slow intravenous injection
15954341|NCT03230734|Drug|Docetaxel|Docetaxel: administered at the dose of 75 mg/m2 by intravenous infusion over a period of 1 hour every 3 weeks for 10 cycles. It is associated with prednisone 5 mg orally twice daily administered continuously.
15954342|NCT03230721|Procedure|Thulium-fiber laser enucleation of the prostate|A high-power (120 W) thulium fiber laser (Urolase, IPG IRE-POLUS, Russia) with wavelength of 1940 nm was used for thulium laser enucleation. In our study, we used a 600-μm laser fiber. The operations were performed at power of 60 W energy of 1.5 J and repetition rate of 40 Hz. Laser power in the verumontanum zone was decreased to 30 W and repetition rate to 20 Hz.
15954343|NCT03230721|Procedure|Monopolar enucleation of the prostate|Monopolar enucleation was performed with a high-frequency generator (50-60 Hz), a pusher-electrode, and a hook-electrode.
15954344|NCT03230721|Procedure|Ho:YAG laser enucleation of the prostate|Holmium laser enucleation of prostatic hyperplasia was performed with a 100 W laser (VersaPulse Powersuite 100, Lumenis, USA/Israel) with wavelength of 2100 nm and 550-μm fiber at the tip. The operation was performed at power of 70 W; it was decreased to 40 W when incisions were made at the verumontanum.
15954345|NCT03230708|Other|Erythrocytes derived MPs containing MTX|General conventional treatment and peritoneal drainage, additional peritoneal perfusion with erythrocytes derived MPs containing MTX
15954346|NCT03230708|Drug|convention drugs|according to usage method of drugs
15954347|NCT03230695|Device|Robotic Therapy|Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
15954348|NCT03230695|Device|Active stimulation|Active transcranial direct current stimulation will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).
15954349|NCT03230695|Device|Sham stimulation|In sham transcranial direct current stimulation, no current will be delivered through the transcranial direct current stimulation device after the first 30 seconds.
15954350|NCT03230682|Drug|antidepressant|regular one-drups treatment of selective serotonin reuptake inhibitor(SSRIs)
15954351|NCT03230669|Other|cbt4cbt|This arm receives treatment as usual and in addition are given access to an online therapy, cbt4cbt. If placed in this group, individuals are asked to use the online therapy for a minimum of 30 minutes each week for the trial duration of 8 weeks.
15954352|NCT03230656|Other|Early cognitive-communication therapy|
15954353|NCT03230643|Device|Barostim neo implantation|"The Barostim neo Implantation is a new promising treatment option for patients with advanced heart failure (HEFrEF) as it might improve cardiac and vascular function by restoring sympathovagal-balance through its effects on the autonomic nervous system.
~In this observational study, data from patients who have received the Barostim neo System as part of clinical routine will be collected and analyzed. The implantation of this new device is not part of the study."
15954354|NCT03230630|Diagnostic Test|plasma melatonin levels|
15954355|NCT03230617|Device|Mechanical ventilator|Mechanical ventilation, in the healthcare setting or home, helps patients breathe by assisting the inhalation of oxygen into the lungs and the exhalation of carbon dioxide. Depending on the patient's condition, mechanical ventilation can help support or completely control breathing.
15954356|NCT03230604|Device|Filtek Bulk Fill Composite and Tetric N Ceram Bulk Fill Composite|Restorative cavities one, two and five with material Filtek Bulk Fill Composite
15954357|NCT03230604|Device|Z 350 Xt Composite|Restorative cavities one, two and five with material Z 350 XT Composite
15954358|NCT03230591|Other|Echocardiography|LV vortex flow in Echocardiography
15954359|NCT03230578|Other|Pharmacists & women's perspectives on pharmacist prescribed hormonal contraception|The goal of this study is to identify the thoughts and perceptions of pharmacy access to hormonal contraception among rural women and pharmacists. This will be key in order to address concerns or perceived barriers in order to inform the implementation of this program.
15954360|NCT03230565|Drug|Ropivacaine|Patient will be given a continuous infusion of local anesthetic.
15954361|NCT03230565|Drug|Ropivacaine|Patient will be given a scheduled intermittent bolus of local anesthetic.
15954362|NCT03230552|Other|Instructional surgical video|An instructional surgical video shown to residents before they perform LSO surgery.
15954363|NCT03230539|Drug|Ulipristal Acetate IUS delivering Cu and 5μg|This is a proof-of-concept study utilizing a randomized dose-finding, parallel design to assess the effects of an IUS delivering Cu and 5, 20, or 40 μg of UPA over 12 weeks.
15954364|NCT03230539|Drug|Ulipristal Acetate IUS delivering Cu and 20μg|This is a proof-of-concept study utilizing a randomized dose-finding, parallel design to assess the effects of an IUS delivering Cu and 5, 20, or 40 μg of UPA over 12 weeks.
15954365|NCT03230539|Drug|Ulipristal Acetate IUS delivering Cu and 40μg|This is a proof-of-concept study utilizing a randomized dose-finding, parallel design to assess the effects of an IUS delivering Cu and 5, 20, or 40 μg of UPA over 12 weeks.
15954366|NCT03230526|Drug|[18F]DPA-714 PET scan|"One PET scan using [18F]DPA-714 is done at M2 between two [123I]FP-CIT scan (DaTscan) done at M1 and M35.
~Neuropsychological assessment is done at M0, M18 and M36"
15954396|NCT03230357|Device|PICC guided by EDUG|ECG Doppler ultrasound guidance technology (EDUG) is the combination of MST puncture and ECG technology through the use of ECG Doppler ultrasound machine and valve conduction PICC to conform the localization of EDUG technology by the study of real-world
15954367|NCT03230513|Other|Self Epley Manoeuvre|The patient has to position himself long sitting on the bed, then turn his head 45 degrees to the problematic side. When in this head position, he will rapidly lie himself supine with a pillow under his shoulders. He then turns his head 90 degrees to the opposite direction followed by turning of his body to the same side before returning to a sitting position at the edge of the bed. Each position should be kept for 30 seconds each, and the patient is required to perform 3 cycles of this manoeuvre just prior to going to bed daily for 2 weeks.
15954368|NCT03230513|Other|Brandt-Daroff Exercise|The patient has to sit at the edge of the bed, turn his head laterally 45 degrees to one side and move rapidly into the side lying position, keeping his head in the same position. He then returns upright and turns his head to the opposite direction and the same movement is repeated on the other side. Each position is held for at least 30 seconds and the patient is required to perform it for 5 repetitions, three times a day, daily for 2 weeks duration.
15954369|NCT03230500|Procedure|Computer guided implant placement|Implant will be placed immediately using computer aided surgical guide
15954370|NCT03230487|Drug|BI 1015550|Part 1 - single rising dose. Part 2 multiple rising dose
15954371|NCT03230487|Drug|Placebo|Part 1 - single rising dose. Part 2 multiple rising dose
15954372|NCT03230474|Drug|Morphine|50 patients of this group will receive 5 mg of 0.5% hyperbaric bupivacaine with 0.2 mg morphine in 0.5 ml volume plus 0.5 ml as placebo (total volume 2 mL)
15954373|NCT03230474|Drug|Morphine-Naloxone|50 patients of this group will receive 5 mg of 0.5% hyperbaric bupivacaine with 0.2 mg morphine in 0.5 ml volume plus 5ng\ kg naloxone in 0.5 ml volume (total volume 2mL).
15954374|NCT03230461|Behavioral|Compression depth|
15954375|NCT03230448|Other|questionnaire|after the inclusion patient will answer to a questionnaire about the suicidal intentionality and a second about the alcool consumption
15954376|NCT03230435|Other|Treatment settings as usual.|Treatment according to guidelines and the local instructions (psychotherapy and dietary guidance).
15954377|NCT03230422|Device|normal airway|The Time interval between the laryngoscope blade passing the teeth/gums to the announcing of the first ventilation was recorded as the time to ventilation with the Video laryngoscopy (VL) or conventional direct laryngoscopy (DL)
15954378|NCT03230422|Device|difficult airway|The Time interval between the laryngoscope blade passing the teeth/gums to the announcing of the first ventilation was recorded as the time to ventilation with the Video laryngoscopy (VL) or conventional direct laryngoscopy (DL)
15954379|NCT03230409|Behavioral|Leaflet written in the patient's/family mother tongue|At baseline visit, the parents or carers of the children and/or the young patients themselves (in the case of adolescents >12 years of age), were given a leaflet including questions and answers about the most common doubts that people have about anti-TB treatment (what to do if you forget a dose, if you vomit, if you have stomach ache, etc.). The study nurse read and reviewed the leaflet with the family. This leaflet was available in 10 different languages: Spanish and Catalan (the two official languages of the country), English, French, German, Russian, Romanian, Chinese, Urdu and Arabic.
15954380|NCT03230409|Behavioral|A follow-up telephone call|A follow-up open telephone call was made 7-10 days after the baseline visit and whenever the patient failed to attend the scheduled visits. The parents and/or patient were informed about this. This call was made to reinforce the information, answer any questions that may have arisen and insist on the importance of proper follow-up.
15954381|NCT03230409|Biological|Eidus-Hamilton Test|E-H test was performed twice, 2 weeks after the baseline visit and at the end of treatment. To prevent patients from only taking their medication occasionally, directly before their visits, they were not informed of the purpose of the urine test. This test is a rapid, simple point-of-care method to detect urinary acetyl-isoniazid, the main metabolite of isoniazid, up to 12-24 hours following isoniazid administration and is used as a surrogate marker of treatment adherence. The test consists of placing 4 drops of a 10%potassium cyanide solution and 9 drops of a 10%chloramine solution in a test tube containing 4 drops of patient urine. The result is considered positive if a deep red color develops after 1 minute. If a pink color slowly appears,this indicates that there are only traces of the metabolite. If there is no change in color, the result is considered negative and suggests no recent isoniazid intake. The sensitivity and specificity of this test have been reported to be over 99%
15954382|NCT03230409|Behavioral|A written questionnaire|The parents or carers of the children and/or the young patients themselves were asked to complete a written questionnaire about adherence to anti-TB treatment on all the follow-up visits, which was partially adapted from two validated questionnaires on adherence to chronic therapies (SMAQ compliance test, Svarstad et al., 1999; and Hermes test, Rodríguez-Chamorro et al., 2008).
15954383|NCT03230396|Dietary Supplement|Vitamingum Sport|Vitamin -supplemented chewing gum
15954384|NCT03230396|Dietary Supplement|Vitamingum Immunity|Vitamin -supplemented chewing gum
15954385|NCT03230396|Dietary Supplement|Placebo|Control chewing gum. No vitamin content.
15954386|NCT03230383|Drug|PF-06865571|Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
15954387|NCT03230383|Drug|PF-06865571|Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
15954388|NCT03230383|Drug|PF-06865571|Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
15954389|NCT03230383|Drug|PF-06865571|Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
15954390|NCT03230383|Drug|PF-06865571|Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
15954391|NCT03230383|Drug|PF-06865571|Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
15954392|NCT03230383|Drug|PF-06865571|Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.
15954393|NCT03230383|Drug|Placebo|Matching Placebo for PF-06865571 for each cohort.
15954394|NCT03230370|Other|UFT|The EUEP group receives additional daily 50 mins program focusing on training of the hemiplegic upper extremity,
15954397|NCT03230344|Procedure|open flap debridement|open flap debridement simultaneously with root canal treatment
15954398|NCT03230344|Procedure|open flap debridement|open flap debridement and delayed root canal treatment
15954399|NCT03230318|Drug|derazantinib|derazantinib will be orally administered at 300 mg once per day one hour prior to or two hours after a meal and is supplied as 100 mg capsules.
15954400|NCT03230305|Other|Ethnographic interview|"If a patient is invited to participate in the a clinical trial, inclusion's status (included or/not) will be sought.
~If included: an ethnographic interview will be held with patient (or his representant) who agreed to participate in the clinical trial, his family caregivers, his physician(s) in charge of him and the trial and, and clinical studies technician responsible for management.
~If not included, an ethnographic interview has offered to him, his caregivers, his physician(s) in charge of him and the trial and clinical studies technician responsible for management. In parallel, the reasons for non-inclusion are collected from a pre-established epidemiological questionnaire.
~If a patient is not invited to participate,an ethnographic interview will be held with his physician(s) in charge of him and the clinical trial and with clinical studies technician responsible for management.The reasons for non-invitation will be collected from an epidemiological survey multiple choices."
15954401|NCT03230292|Drug|Bimekizumab|Bimekizumab will be administered subcutaneously in 2 different doses.
15954402|NCT03230279|Procedure|Sacroiliac joint fusion|Minimally invasive SIJ fusion will be performed under general anesthesia with fluoroscopy. Using SI-LOK®, Sacroiliac Joint Fixation System, Globus Medical Inc. (Audubon, PA), this procedure involve placement of 2 to 3 implants across the SIJ to achieve stabilization and arthrodesis.
15954403|NCT03230279|Procedure|Sacroiliac joint radiofrequency ablation|Sacroiliac joint radio frequency ablation will be performed using either conventional or cooled radiofrequency ablation techniques aimed at the S1-S3 lateral branches and the L5 dorsal ramus. The choice between conventional or cooled RFN will be determined by the provider expertise.
15954404|NCT03230266|Procedure|Collection of intra-peritoneal catheters for insulin infusion|Collection of intra-peritoneal catheters for insulin infusion
15954405|NCT03230253|Behavioral|Sequential training|The participant will cycle on a stationary bike for 30 minutes, which includes a 3-min warm-up phase followed by the aerobic training components (25 minutes), then a 2-min cool-down phase. The target heart rate during the aerobic training phase will be 40 to 70% of maximal heart rate (HRmax). After cycling, the participant will engage in a 30-minute of computer-based cognitive training program using BrainHQ (Posit Science Inc., San Francisco, CA, USA). The following are the areas of training: visuospatial processing, attention, memory, language, and logical thinking.
15954406|NCT03230253|Behavioral|Dual training|The dual-task training group will cycling concurrently with the computer-based cognitive training. The training principle of cycling and cognitive training is similar to the SEQ group; however, the training intensity will be adjusted according to each participant's ability.
15954407|NCT03230253|Behavioral|Control training|The control participants will receive 60 minutes of health-related rehabilitation programs which involves non-aerobic physical exercise (e.g., muscle stretching, range of motion exercises, relaxation techniques) and unstructured cognitive related rehabilitation programs (e.g., watch health-related videos or read newspapers or magazines and then answer the content-related questions raised by the therapist).
15954408|NCT03230240|Drug|HIPEC|heated intraIP chemotherapy
15954409|NCT03230227|Drug|Bupivacaine magnesium|bupivacain 0.125% magnesium sulfate 5%) infusion in the presternum , for 48 hours
15954410|NCT03230227|Drug|Bupivacaine only|bupivacaine 0.125% infusion in the presternum , for 48 hours
15954411|NCT03230214|Diagnostic Test|PCR for bacterial translocation|samples taken from the blood and ascites of patients to search for bacterial DNA
15954412|NCT03230201|Procedure|Lymph node dissection|Lymph node dissection during radical nephroureterectomy
15954413|NCT03230188|Other|functional Magnetic Resonance Imaging (research grade)|Subjects will undergo a simulated and actual functional Magnetic Resonance Imaging scan.
15954414|NCT03230188|Other|Cognitive Function Testing (non-diagnostic)|Subjects will take non-diagnostic cognitive function tests
15954415|NCT03230188|Other|Asthma and Psychological Questionnaires (non-diagnostic)|Subjects will fill out asthma and psychological questionnaires (non-diagnostic)
15954416|NCT03230175|Biological|TTAX01|TTAX01 will be applied directly to the wound surface and retained with non-absorbable sutures. A single layer of the test article should cover the entire open surface of the wound. The material is to be applied once every 4 weeks unless the wound shows evidence of healing, in which case dosing is suspended; or, if the test article has been accidentally dislodged, it may be replaced at any time.
15954417|NCT03230175|Procedure|Surgical resection and debridement|"Perform surgical sharp debridement in the OR, to remove:
~infectious agents and biofilms (purulence),
~all debris, eschar, callus and macerated non-viable tissue from the wound base, and
~dead (suprabasal epidermis), scarred (elevated/edematous) and necrotic/macerated tissue from the wound edge.
~Surgical Resection will be performed to remove as much of the necrotic bone detected by the radiographic evidence as is appropriate."
15954418|NCT03230175|Drug|Systemic antibiotics|Six (6) weeks of systemic antibiotic therapy is required. A definitive therapy will be guided by the microbiological results based on bone biopsy.
15954419|NCT03230175|Device|Off-loading|Provide off-loading device appropriate to the location of wound with full length boot or total contact cast
15954420|NCT03230162|Drug|Sildenafil|sildenafil citrate 25 mg every 8 hours (Silden EIPICO co.) orally, starting at the diagnosis of FGR till delivery
15954421|NCT03230162|Drug|low molecular weight heparin|a single daily dose of LMWH (tinzaparin) (Innohep LEO pharmaceutical products.) subcutaneously starting at diagnosis of FGR till delivery
15954422|NCT03230149|Diagnostic Test|Measurements of the alpha-GAL enzyme activity|Blotting paper blood tests in order to highlight an enzyme deficiency for hemizygous males with DBS kits in order to detect Fabry disease, with genetic confirmation if an abnormality is detected. For women genotyping is mandatory.
15954423|NCT03230136|Other|multimodal cardioprotection strategy|Multimodal cardioprotection therapeutic strategy will include (1) remote ischemic preconditioning, (2) volatile anesthetic sevoflurane-induced preconditioning, (3) blood glucose control every 30 minutes during cardiac surgery, (4) temporary respiratory acidosis prior to the aortic cross-unclamping and (5) gradual restoration of blood flow after aortic cross-unclamping (gentle reperfusion).
15954494|NCT03229577|Behavioral|Mindfulness-Based Stress Reduction|Mindfulness program.
15954424|NCT03230136|Other|standard anesthetic procedure|standard anesthetic procedure will include: anesthesia under propofol throughout the cardiac surgery, blood glucose control every 60 minutes, arterial pH maintained at 7.40, theoric blood flow restored at the earliest after aortic cross-unclamping.
15954425|NCT03230123|Dietary Supplement|Green banana biomass|Green banana biomass will be suplemented to diet as 4.5 g per day.
15954426|NCT03230110|Diagnostic Test|WP200U home sleep study device|WP200U, is a Type III, wrist-worn, FDA-approved home sleep testing device that utilizes finger plethysmography (peripheral arterial tone, oxyhemoglobin saturation and heart rate), actigraphy (movement), acoustic decibel detection (snoring volume), and accelerometry (body position) to help diagnose sleep-related breathing disorders (including snoring), and to give information about sleep stages and position during actual sleep time.
15954427|NCT03230097|Drug|BI 409306|twice daily
15954428|NCT03230097|Drug|Placebo|twice daily
15954429|NCT03230084|Device|Urine PDG test|Urine dipstick test that detects the presence of the urinary metabolite of progesterone, PDG.
15954430|NCT03230071|Drug|TMBCZG|0.1g per pill which contains 14mg TMBCZG
15954431|NCT03230071|Other|placebo|0.1g per pill which contains 0mg TMBCZG
15954432|NCT03230058|Drug|Group 1 Natamycin 5% Suspension + voriconazole 1% eye drops; Group 2 Natamycin 5% Suspension + Vehicle eye drops|instillation of drops
15954433|NCT03230045|Device|acupoint stimulation|Acupoint Zhongfu and Zusanli are stimulated through electrodes attached on the skin
15954434|NCT03230045|Device|no treatment|electrodes are attached, but no stimulation is given
15954436|NCT03230019|Procedure|chest tube|VATS with chest tube placement
15954437|NCT03230019|Procedure|two-lumen catheterization|VATS with two-lumen catheterization long the midclavicular line, second intercostal space
15954438|NCT03230019|Device|two-lumen catheter|central venous catheter(two-lumen 7-Fr-20cm)
15954439|NCT03230006|Behavioral|Unified Protocol for Transdiagnostic Treatment of Emotional Disorders|The UP will be conducted in a standardized fashion, over 16 sessions, following the published therapist guide with minor refinements for application in the proposed comorbid population.
15954440|NCT03230006|Behavioral|Take Control|TC is a psychotherapy platform derived from the National Institute on Alcohol Abuse and Alcoholism's (NIAAA) self-help approach, Rethinking Drinking. In this study, TC, originally designed as a computerized treatment has been modified to be administered by the therapist to control for effects that may be related to patient-therapist interaction (as opposed to elements of the treatment itself). Specifically, on a weekly basis, therapists will review material from TC and offer general advice on implementation of the alcohol reduction skills in daily life.
15954441|NCT03229993|Diagnostic Test|OCT|OCT is used to assess whether PCI will be of benefit to the treatment of the borderline coronary artery lesions
15954442|NCT03229980|Drug|Cold blood cardioplegia (large volume)|Hearts will be arrested with cold blood cardioplegia, first dose (arrest dose) will be 30 ml/kg and the frequent doses every 20 min will be 15 ml/kg
15954443|NCT03229980|Drug|Cold blood cardioplegia (small volume)|Hearts will be arrested with cold blood cardioplegia first dose (arrest dose) will be 10 ml/kg and the frequent doses every 20 min will be 5 ml/kg
15954444|NCT03229967|Diagnostic Test|16S rRNA stool microbiome sequencing.|This is an observational cohort that will undergo gut microbiome sequencing.
15954445|NCT03229954|Drug|iron isomaltoside (Monofer) intravenous infusion|"The investigational drug is a newest formulation of intravenous iron. The drug, iron isomaltoside (Monofer), will be infused one single high dose with infusion time more than 30 minutes (< 1,000 mg) or 60 minutes (≥ 1,000 mg). The dosage is determined using the Ganzoni formula and divided when the calculated dose exceeds 20 mg/kg.
~If the calculated dose exceeds 1,500 mg, the patient will be excluded from trial for patient safety."
15954446|NCT03229954|Drug|Ferrous sulfate(Feroba-YOU) per oral|160 mg/day of ferrous sulfate (Feroba-YOU) will be taken per oral for 12 weeks.
15954447|NCT03229941|Procedure|Blood Transfusion|Blood Transfusion
15954448|NCT03229928|Device|MOCHA|"MOCHA phone-based application
~Event tracker button that marks the beginning and end of a behavioral event. Similar to a FOB that connects to MOCHA application via bluetooth
~Wrist based sensor (applicable only to sensor wearing participants)."
15954449|NCT03229915|Behavioral|cognitive processing therapy|Group therapy for PTSD patients
15954450|NCT03229902|Behavioral|mantra meditation|see study description
15954451|NCT03229889|Drug|Cialis 5Mg Tablet|Cialis is a PDE-5 inhibitor that has been shown to relax smooth muscle. Patients will be asked to 1 pill for 7 days prior to surgery.
15954452|NCT03229889|Drug|Flomax 0.4Mg Capsule|Tamsulosin is an alpha-blocker that has been shown to relax smooth muscle in the genitourinary system. Patients will be asked to 1 pill for 7 days prior to surgery.
15954453|NCT03229889|Combination Product|Cialis + Flomax|Cialis is a PDE-5 inhibitor that has been shown to relax smooth muscle. Tamsulosin is an alpha-blocker that has been shown to relax smooth muscle in the genitourinary system. A combination of these two drugs may increase the relaxation effects in the ureter. Patients will be asked to 1 of each pill for 7 days prior to surgery.
15954454|NCT03229889|Drug|Placebo|This is plant cell based pill that contains no active ingredient. Patients will be asked to 1 pill for 7 days prior to surgery.
15954455|NCT03229876|Biological|CD19-UCART|A conditioning therapy with cyclophosphamide and fludarabine will be conducted before CD19-UCART injection. VP16 can be added to the conditioning therapy.
15954456|NCT03229863|Other|Sweet Potatos|Plum Organics, Just Sweet Potato
15954457|NCT03229863|Other|Pears|Earth's Best, First Pears
15954458|NCT03229850|Drug|Insulin lispro|Insulin lispro will be injected into the abdomen into an area of subclinical lipohypertrophy or an area with no subclinical lipohypertrophy
15954459|NCT03229824|Device|Antiseptic occlusive dressing group|A chlorhexidine gluconate occlusive adhesive dressing (Tegaderm CHG) will be applied to the intervention drain sites and changed every seven days.
15954460|NCT03229811|Other|ESRD education + conservative kidney management and ACP education|Targeted conservative kidney management and advance care planning education delivered in person by trained healthcare providers
15954461|NCT03229798|Drug|Sumatriptan Succinate Oral Tablet|Sumatriptan succinate commercial Imitrex 100 mg tablet
15954462|NCT03229798|Combination Product|Transdermal delivery of sumatriptan succinate|Sumatriptan succinate transdermal drug delivery system
15954463|NCT03229785|Biological|Human Umbilical Cord Blood Plasma|Plasma collected from human umbilical cord blood
15954464|NCT03229772|Device|Discovery NM/CT 670 CZT Imaging Scan|At a single visit, subjects will undergo nuclear medicine scintigraphy imaging scanning on the investigational GE Discovery 670 NM/CT CZT (with CZT) device and the commercial GE Discovery 670c (without CZT).
15954465|NCT03229759|Drug|Octenidine Dihydrocloride in aqueous solution|application of investigational product
15954466|NCT03229759|Other|Vehicle Control|application of vehicle control
15954467|NCT03229759|Other|Saline Control|application of placebo
15954468|NCT03229746|Drug|Hydroxychloroquine|200mg twice daily orally for at least 12 weeks
15954469|NCT03229746|Drug|vincristine|1mg intravenous weekly for 4 weeks
15954470|NCT03229746|Drug|azathioprine|dose 100mg daily for at least 3 weeks
15954471|NCT03229733|Device|Kinect|Receive Kinect games training for 30 minutes. There are 3 sections for 1 week; the intervention period will be 8 weeks
15954472|NCT03229733|Behavioral|Traditional occupational therapy|Patients will receive individually tailored conventional training consisting of the similar movement and dose by using the traditional equipment, such as climbing bar.
15954473|NCT03229720|Device|Nibiru 3D Virtual Reality Headset|This device is a kind of head glass that obstructs the vision with a wide screen showing movies or photos. Earphones are extended from it and inserted in ears. so it obstructs the vision and audio of the surroundings.
15954474|NCT03229707|Device|Digital photography using software Photoshop|"When taking the image, a gray card is used for subsequent exposure calibration in Adobe Camera Raw (which is packaged with Photoshop).
~Images are then opened into Photoshop.
~The INFO panel must be open.
~Click on the small eyedropper in the Info panel window and click on ''Lab Color.
~Place the mouse over the center of the tooth to be measured for L value.
~Click on the HSB Color option, which stands for hue, saturation, and brightness."
15954475|NCT03229707|Device|Vita 3D master shade guide|Alpha (A)Perfectly matched Beta (B)Not perfectly matched Charlie (C)unacceptable Determent by 10 observers
15954476|NCT03229694|Drug|Tracleer 125Mg Tablet|Tracleer was administered orally at two hours before surgery and six hours after surgery.
15954477|NCT03229694|Drug|Placebo|Placebo was administered orally at two hour before surgery and six hours after surgery.
15954478|NCT03229681|Behavioral|Baduanjin exercise|"Participants in this groups received routine rehabilitation training and Baduanjin exercise. During the period of rehabilitation, physicians provides a wide range of medical, nutrition and mental health counseling, as well as rational drug-treatment. Baduanjin exercise protocol according to the Health Qigong Baduanjin Standard enacted by the General Administration of Sports in 2003. Due to the low-activity tolerance of CHF patients, we performed with a refined version of Baduanjin. Each Baduanjin exercise session lasts 45 minutes and continues twice per week for 12 weeks."
15954479|NCT03229681|Behavioral|Routine rehabilitation group|Participants in this qroup only received the routine rehabilitation training. During the period of rehabilitation, physicians provides a wide range of medical, nutrition and mental health counseling, as well as rational drug-treatment. They should also come to rehabilitation center for physical exercise,45 minutes per day，twice per week, lasts 12 weeks.
15954480|NCT03229668|Drug|Placebo oral capsule|Placebo oral capsule administered 1 hour prior to the surgical operation
15954481|NCT03229668|Drug|Pregabalin Oral Capsule [Lyrica] 75mg|Pregabalin Oral Capsule [Lyrica] 75 mg administered 1 hour prior to the surgical operation
15954482|NCT03229668|Drug|Pregabalin Oral Capsule [Lyrica] 150 mg|Pregabalin Oral Capsule [Lyrica] 150 mg administered 1 hour prior to the surgical operation
15954483|NCT03229655|Procedure|Protocol for increasing number of stents across the anastomosis|Sequential placement of straight plastic biliary stents across the duct-to-duct anastomosis without dilation or stent exchange. Multiple ERCPs will be performed with addition of a single stent at each ERCP until the final ERCP when all stents will be removed.
15954484|NCT03229642|Device|Active rTMS|The stimulator device was a Magstim super rapid magnetic stimulator (Magstim Company, Ltd., Wales, United Kingdom) with 4 booster modules equipped with a 70-mm air-cooled figure-eight-shaped coil. We performed rTMS on the left dorsolateral prefrontal cortex (DLPFC).The TMS parameters were as follows: 15Hz frequency, pulse intensity 100% of the rMT, 60 pulses per train, inter train pause of 26 sec, 40 stimulation trains, and 2400 total pulses for a total duration of 20 min. The patients received one rTMS session per day during the first five days of treatment, and then twice a week for the following three weeks, for a total of 11 rTMS sessions. The sham group was administered rTMS with the same parameters, but using a figure-of-eight sham coil.
15954485|NCT03229642|Device|Sham rTMS|The stimulator device was a Magstim super rapid magnetic stimulator (Magstim Company, Ltd., Wales, United Kingdom) with 4 booster modules equipped with a 70-mm air-cooled figure-eight-shaped coil. We performed rTMS on the left dorsolateral prefrontal cortex (DLPFC).The TMS parameters were as follows: 15Hz frequency, pulse intensity 100% of the rMT, 60 pulses per train, inter train pause of 26 sec, 40 stimulation trains, and 2400 total pulses for a total duration of 20 min. The patients received one rTMS session per day during the first five days of treatment, and then twice a week for the following three weeks, for a total of 11 rTMS sessions. The sham group was administered rTMS with the same parameters, but using a figure-of-eight sham coil.
15954486|NCT03229629|Behavioral|Behavior change communication|Weekly behavior change communication (BCC) to mothers for the duration of 16 weeks Weekly behavior change communication (BCC) to fathers for the duration of 12 weeks
15954487|NCT03229629|Other|Food Voucher (Monetary)|Monthly voucher worth 200 birr(~$10) every month for the duration of 6 month
15954488|NCT03229616|Drug|Busulfan (BU)|Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.
15954489|NCT03229616|Drug|Cyclophosphamide (CY)|Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
15954490|NCT03229616|Drug|Etoposide (VP-16)|Etoposide was administered at 15 mg/kg/day on days -3 to -2.
15954491|NCT03229603|Other|Cluster of 3000 women|An evaluation of the feasibility, reach, adoption and implementation of a cervical cancer screening program where we diagnose HPV using the GeneXpert point of care testing kit prior to VIA and cryotherapy.
15954492|NCT03229590|Procedure|Surgical dislocation|Reduction of slipped epiphysis by surgical dislocation
15954493|NCT03229577|Behavioral|Sudarshan Kriya Yoga|Yoga-based breathing program.
15954495|NCT03229577|Behavioral|Emotional Intelligence|Emotional Intelligence program.
15954496|NCT03229564|Biological|EHSG-KF|Transplantation of autologous dermo-epidermal skin substitute EHSG-KF to the experimental area
15954497|NCT03229564|Biological|STSG|Transplantation of autologous split-thickness skin graft to the control area
15954498|NCT03229551|Drug|Xylitol|Topical 5% Xylitol (wt/vol) diluted in saline nasal irrigant. Topical corticosteroid and antibiotic as directed by bacterial DNA sequencing results will be diluted in this irrigant and administered concurrently.
15954499|NCT03229551|Drug|Saline|Saline as a standard-of-care nasal irrigant. Topical corticosteroid and antibiotic as directed by bacterial DNA sequencing results will be diluted in this irrigant and administered concurrently.
15954500|NCT03229538|Drug|Methylprednisolone|IV Steroid pre-operative and intra-operative
15954501|NCT03229538|Drug|Isotonic saline|Isotonic saline pre-operative and intra-operative
15954502|NCT03229525|Behavioral|Trauma Related Expressive Writing|Participants will write about the traumatic event over the course of six sessions.
15954503|NCT03229525|Behavioral|Neutral Expressive Writing|Participants will write about a neutral event over the course of six sessions.
15954504|NCT03229512|Drug|Sildenafil|Topical 1% Sildenafil Cream
15954505|NCT03229499|Drug|Anastrozole|"Anastrozole is an aromatase inhibitor indicated for:
~adjuvant treatment of postmenopausal women with hormone receptor-positive breast cancer
~first-line treatment of postmenopausal women with hormone receptor-positive or hormone receptor unknown locally advanced or metastatic breast cancer
~treatment of advanced breast cancer in postmenopausal women with disease progression following tamoxifen therapy."
15954506|NCT03229499|Drug|Placebo Oral Tablet|matching placebo tablet
15954507|NCT03229486|Drug|Sugammadex Injection [Bridion]|Return to T2 point (two contractions) on TOF device is replied by iv 2 mg/kg sugammadex administration, contained in a blinded syringe.
15954508|NCT03229486|Drug|Neostigmine+Glycopyrronium|Return to T2 point (two contractions) on TOF device is replied by iv 0.06 mg/kg neostigmine and 0.005 mg/kg glycopyrrolate administration, contained in a blinded syringe.
15954509|NCT03229460|Other|standard low flow therapy|In the standard low flow therapy oxygen group, oxygen at a flow rate of 10 liters per minute or more.
15954510|NCT03229460|Device|high flow nasal oxygen therapy|The patient will receive high flow nasal of humidified oxygen, set between 30 to 60 l/min. The inspired fraction of oxygen (FiO2) will be adjusted in order to obtain a SpO2 >92%.
15954511|NCT03229460|Device|association of high flow nasal oxygen therapy and non invasive positive pressure ventilation|The patient will receive successively in a day NPPV and O2-HFN. The NPPV will be applied with an airway humidification achieved by using a heated humidifier and a facial mask adapted to the morphology of the patient. The settings will be adjusted as follow : an inspiratory pressure between 6 to 14 cmH2O, in order to obtain a tidal volume between 7 to 10 ml/kg of predicted weight, a positive expiratory pressure between 0 to 10 cmH2O in order to obtain a SpO2 >92% with the minimal FiO2.
15954512|NCT03229447|Behavioral|eLearning Modules|All participating courts will view two eLearning modules. Module one discusses opioid addiction and treatment; module two discusses specific concerns of criminal justice with regard to MAT and ways in which those concerns may be addressed.
15954513|NCT03229447|Behavioral|Change Team Intervention|Courts selected for the experimental condition will participate in a hands-on change team intervention to provide instrumental assistance and to reinforce the information contained in the eLearning modules.
15954514|NCT03229434|Behavioral|Mountain hiking|Compare arm description
15954515|NCT03229421|Other|Survey|18 question symptom assessment tool including non-identifying demographic information questions.
15954516|NCT03229408|Drug|Salsalate|Lean PCOS Arms: Salsalate 1.5 gm PO bid; Obese PCOS Arm: Salsalate 2.0 gm PO bid
15954517|NCT03229408|Other|Placebo|Appears identical to experimental drug
15954518|NCT03229382|Drug|Obinutuzumab|Patients, in whom all inclusion criteria have been confirmed and all exclusion criteria have been ruled out, will receive 4 intravenous infusions of obinutuzumab (GA101, Gazyvaro) at a dose of 1000 mg on Days 1, 8, 15 and 22.
15954519|NCT03229369|Procedure|Isolated anatomic ACL reconstruction|Hamstrings free grafts using a two-incision intra-articular Anterior Cruciate ligament (ACL) reconstruction technique. Both ST and gracilis will be prepared with doubled strands, a standard quadrupled graft. The femoral tunnel will be performed in outside-in manner. The tibial tunnel will be drilled in the center of the ACL tibial footprint, sparing the ACL tibial stump, when possible. ACL graft will be first fixed in the femur and then in the tibia, both with an interference screw at 30 degrees of knee flexion.
15954520|NCT03229369|Procedure|Combined Anterior Cruciate Ligament and Anterolateral Ligament reconstruction|Hamstrings free grafts using a two-incision ACL reconstruction with the addition of a gracilis prolongation for ALL reconstruction. ACL graft will exhibit a quadruple strand (tripled ST + single gracilis) and the ALL graft, a single strand with the gracilis prolongation. ALL tibial tunnel will be performed with a 5mm drill, 1cm distal to the articular level, midway from the fibular head and Gerdy Tubercle, crossing the tibia toward its anteromedial cortex, 1cm distal to the ACL tunnel. Femoral ACL and ALL tunnels are coincident and located posterior and proximal to the lateral epicondyle. Intra-articular surgery will be performed in the same manner as comparative group. Gracilis prolongation is routed through the tibial ALL tunnel and then retrieved in the anteromedial aspect of the tibia, 1cm distal to the ACL tunnel entrance. ALL is fixed in full extension and neutral rotation, tying both graft extremities with 3 knots.
15954521|NCT03229356|Other|Best Practices Advisory (BPA)|"BPA: The BPA is an Epic prompt that fires when a provider opens an encounter with a patient who is actively smoking. Providers will be asked to assess smoking cessation readiness and to refer patients to the free Maryland Quit Line if the patient is receptive. The Quit Line will receive an electronic referral with the patient's details. A Quit Line certified smoking cessation counselor will then call the patient at a later date and provide counseling. Receptive patient will receive up to four calls. They will receive counseling from a trained quit coach and be offered free access to NRT.
~Quit Line: This free telephone-based counseling service is offered to smoker in Maryland. Services offered include on-the-phone smoking cessation counseling and free nicotine replacement."
15954591|NCT03228732|Drug|Fluoxetine and DHEA|There will be two 2-day inpatient visits with 8-weeks of treatment with fluoxetine and DHEA between those visits.
15954762|NCT03227653|Drug|Efavirenz|Weight-based dosing according to the National Guidelines for the Management of HIV and AIDS
15954522|NCT03229356|Other|BPA + Enhanced Education|BPA with Quitline Referral plus 1)Consolidated educational hand out: The hand out will include a information about counseling, pharmacotherapy, and cessation referrals 2)Online modules: Providers will be directed to optional, self-paced educational modules through the Maryland HABITS program 3)Academic detailing: This will include a single session during a clinic day in which counseling experts from the MD Quit Line will visit providers in their practice setting.
15954523|NCT03229343|Other|Supportive care|supportive care, systematic and joint to pneumological consultation, monthly, starting at M0 and continuing up to M6.
15954524|NCT03229330|Procedure|Low-level Light Therapy|Low-level Light Therapy 660nm (red laser), 1 to 3 Joules, irradiation time and number of points varied.
15954525|NCT03229330|Combination Product|Conventional treatment|Topical treatment: essential fatty oil, hydrogel, papain gel, petrolatum gauze, calcium or silver alginate, zinc oxide and barrier cream; and high compression bandage SurePress
15954526|NCT03229317|Other|Plethysmography|Lung plethysmography
15954527|NCT03229291|Drug|SM04755|SM04755 is a small molecule inhibitor of the Wnt pathway.
15954528|NCT03229291|Drug|Vehicle|Same formulation as topical SM04755 solution, without SM04755 included.
15954529|NCT03229278|Drug|Enzyme Inhibitor Therapy|Given trigriluzole PO
15954530|NCT03229278|Other|Laboratory Biomarker Analysis|Correlative studies
15954531|NCT03229278|Biological|Nivolumab|Given IV
15954532|NCT03229278|Biological|Pembrolizumab|Given IV
15954533|NCT03229265|Drug|Patiromer|Patiromer (8.4 grams) will be taken daily at 3 hours after oral tacrolimus and MMF dosing by subjects commencing 3 days (± 1 day) prior to visit 1.
15954534|NCT03229252|Drug|Placebo Inhalation Solution|Normal Saline Inhalation Solution
15954535|NCT03229252|Drug|SPX-101|SPX-101 Inhalation Solution
15954536|NCT03229239|Procedure|corneal stroma implantation|During the operation,implant the corneal stroma to the diseased cornea of keratoconus.
15954537|NCT03229226|Other|Verbal versus procedural assessment|Faculty were assessed on both verbal and simulated performance of procedures.
15954538|NCT03229200|Drug|Ibrutinib|Subjects will continue with the current ibrutinib dosing regimen established in the parent ibrutinib study.
15954539|NCT03229174|Drug|Droxidopa|Droxidopa initial dose 100mg TID, titrated in increments of 100mg every 24-48 hours to symptomatic response.
15954540|NCT03229174|Drug|Placebo|Placebo (sugar pill)
15954541|NCT03229161|Behavioral|IWT-group|
15954542|NCT03229148|Procedure|General anaesthesia|Procedure in which patients are induced into an unconscious state through use of various medications so that they do not feel pain during surgery
15954543|NCT03229148|Procedure|Conscious Sedation|A drug-induced depression of consciousness during which patients respond purposefully to verbal commands, either alone or accompanied by light tactile stimulation. No interventions are required to maintain a patent airway. (From: American Society of Anesthesiologists Practice Guidelines)
15954544|NCT03229135|Device|other antibacterial agents，breathing machine|If treatment failure for patients in group A，group B，group C and group D，change dose of teicoplanin or other antibacterial agents. Mechanical ventilation was adopte.Treatment failure was defined as no improvement or worse of clinical symptoms, laboratory data, requiring change of teicoplanin therapy.
15954545|NCT03229109|Device|Spectrophon dehydration body monitor|Participants (both males and females) were assigned to physical activity (running), biosensor was attached to subject's wrist
15954546|NCT03229096|Drug|Apatinib plus XELOX|"three weeks is one cycle, 4 cycles followed by radical gastrectomy. Apatinib: 250 mg, p.o., qd, every 3 weeks for the first two cycles. if no level 3 or severer AEs happened, change apatinib to 500mg, p.o.,qd, otherwise keep 250mg in the third cycle. no apatinib in the fourth cycle.
~Capecitabine: 1000mg/m2, p.o., bid, D1-14, every 3 weeks (treatment for 2 weeks and rest 1 week).
~Oxaliplatin: 130mg/m2, i.v. over 2h, D1, every 3 weeks."
15954547|NCT03229083|Other|Carevive software|In this study, Carevive will deliver a link to subjects so that an online survey can be completed. The survey will occur weekly for the first 12 weeks of the study and will be spaced out to every other week thereafter. The questions will mostly focus on side effects from their cancer therapy, as well as a few questions about drug compliance and healthcare utilization. After completion of the survey, the subject will be given a care plan with at home self-management options for drug-related toxicities.
15954548|NCT03229070|Other|Interval effort group|Pre-surgical evaluations (Six-minute walk test, sit and lift test 30 in seconds, and Piper fatigue scale) Active phase (high load) lasting 60 seconds, followed by an active recovery phase with light / moderate load (60% of the maximum load) lasting 4 minutes. The pedaling speed should be maintained between 30-60rpm. There will be 5 cycles that will total 20 minutes of physical effort, and assessments at discharge.
15954549|NCT03229070|Other|Continuous effort group|Pre-surgical evaluations (Six-minute walk test, sit and lift test 30 in seconds, and Piper fatigue scale) Intensity used will be mild / moderate, ie 60% of the maximum load reached in the incremental test. The pedaling speed should be maintained between 30-60rpm. The execution time, from this exercise regime will be 20 minutes, and assessments at discharge.
15954550|NCT03229057|Drug|OCP + Metformin|This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
15954551|NCT03229057|Drug|OCP + Placebo|This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
15954614|NCT03228615|Other|SDM Intervention|Intervention Component A: letter to activate families; Intervention Component B: in-clinic decision support; Intervention Component C: follow-up phone call
15954552|NCT03229057|Drug|Metformin + Placebo|This will be a three-arm, double-blind, double-dummy, multicenter, prospective, randomized clinical trial comparing OCP vs. Metformin vs. OCP + Metformin on the prevalence of MetS in women with PCOS. This 6-month study will consist of a screening visit, followed by 6 study visits (Subjects will undergo 6 in person study visits and life style modification counseling regarding diet and exercise. Phone contact will be made 2 weeks after randomization and at the end of each month when there is no in person visit to ensure study compliance with medications, keeping study logs and to review side effects). No longer term follow-up is planned.
15954553|NCT03229044|Genetic|Tetranectin|Adipose tissues were obtained from the breast of breast cancer patients with 0 to 1 progression stage. The subjects were 33-51 y of age (mean = 43.6, SD = 6.2) with a BMI of 16-33 kg/m2 (mean = 21.5, SD = 4.5). Blood samples were collected after an overnight fasting. Serum was separated by centrifugation and stored at -80 ℃ until analysis. Plasma Tetranectin,triglyceride (TG), high density lipoprotein (HDL), low density lipoprotein (LDL), cholesterol, glucose and insulin were measured. And the tetranectin mRNA and protein level was measure in adipose tissue
15954554|NCT03229031|Drug|ES135|ES135 will be administered via intrathecal
15954555|NCT03229018|Diagnostic Test|Voxel size|200 μm and 300 μm Voxel Sizes
15954556|NCT03229005|Procedure|implant insertion|during surgery soft tissues will be measured
15954557|NCT03229005|Procedure|operculectomy|during second surgery soft tissues will be measured again
15954558|NCT03229005|Procedure|prosthetic rehabilitation|after three months implants will be loaded with screw retained crown
15954559|NCT03228992|Drug|Ibuprofen 400 mg|Subjects will receive 4 doses of oral ibuprofen over a 24 hour period.
15954560|NCT03228992|Other|Placebo|Subjects will receive 4 doses of placebo over a 24 hour period.
15954561|NCT03228979|Other|Structured Semi-Interactive Stroke Prevention Package|The intervention arm will receive a Structured Semi-Interactive Stroke Prevention Package including patient workbook, short messaging services and health education videos for a period of one-year in addition to standard of care as per current guidelines.
15954562|NCT03228966|Diagnostic Test|Echocardiogram|Screening echocardiogram
15954563|NCT03228953|Other|Pharmacogenomic testing|Pharmacogenomic testing is delivered to treating providers of patients with major depressive disorder
15954564|NCT03228940|Drug|RVX000222|oral, BID
15954565|NCT03228927|Other|comparison of twin A to twin B|Comparison of Twin A to Twin B
15954566|NCT03228914|Drug|Oxymetazoline|Pledgets will be soaked in 0.05% oxymetazoline solution Two pledgets with the associated medication will be placed into the nasal cavity; one along the floor of the nose and another directed towards the middle meatus.
15954567|NCT03228914|Drug|Epinephrine|Pledgets will be soaked in 1:1000 epinephrine solution Two pledgets with the associated medication will be placed into the nasal cavity; one along the floor of the nose and another directed towards the middle meatus.
15954568|NCT03228901|Drug|Oxytocin|Administration of the hormone oxytocin
15954569|NCT03228901|Drug|Placebos|
15954570|NCT03228888|Other|Administration of rhytmic acoustic stimuli for gait training|The intervention consist in 5 weeks, 20 min/day gait training assisted by rhythmic acoustic stimuli administered using a portable MP3 player
15954571|NCT03228862|Drug|Ergocalciferol|Ergocalciferol 40000, 60000 and 80000 once weekly
15954572|NCT03228849|Procedure|Suture anchor technique|Suture anchors were used to attach bony fragment. On week 6, patients were then started on physical therapy for 2 weeks.
15954573|NCT03228849|Procedure|Conservative Treatment|The injured finger was immobilized in an aluminium splint for 6 weeks. Patients were then started on physical therapy for 2 weeks.
15954574|NCT03228836|Drug|Sintilimab|Sintilimab (IBI308) 200mg IV Q3W
15954575|NCT03228823|Procedure|Radiofrequency ablation|RFA to achieve PVC suppression will be performed using standard techniques and protocols similar to those patients that do not participate in this clinical study.
15954576|NCT03228823|Drug|Amiodarone (Antiarrhythmic drug)|AAD therapy of choice is amiodarone. Amiodarone loading dose of 10 grams is recommended, followed by maintenance dose of 200-400mg daily to achieve successful PVC suppression. Alternatively, sotalol and/or propafenone could be considered at discretion of electrophysiologists (sotalol dose of at least 120mg twice daily, propafenone 150-300mg tid) if there is a significant concern of safety profile of amiodarone.
15954577|NCT03228810|Other|Blood draw|(2) 10 mL tubes will be collected
15954578|NCT03228810|Procedure|Tissue biopsy|Tissue biopsy of metastatic tissue if undergoing clinical care-directed biopsy
15954579|NCT03228797|Procedure|an ultrasound guided rectus sheath block|
15954580|NCT03228797|Procedure|multiholed catheter|gauge multiholed catheter will be inserted at the end of surgery and after the closure of the peritoneal layer at 3 to 5 cm away from the lower end of the surgical incision
15954581|NCT03228797|Procedure|an ultrasound guided rectus sheath block &multiholed catheter|a multiholed catheter will be inserted as in Group II and will receive also an ultrasound guided rectus sheath block as described for Group I.
15954582|NCT03228784|Procedure|LASIK|
15954583|NCT03228771|Drug|PRGF/ATV|Atorvastatin loaded in PRGF fibrin scaffold
15954584|NCT03228771|Drug|ATV gel|Atorvastatin loaded in methyl cellulose gel
15954585|NCT03228758|Procedure|Per Oral Endoscopic Myotomy|The Per Oral Endoscopic Myotomy procedure is the cutting of the lower esophageal sphincter. This procedure is a natural orifice transluminal endoscopic surgery (NOTES)
15954586|NCT03228745|Behavioral|Pre-operative MBSR|A MBSR program typically consists of 8 weekly 2.5 hour sessions, home practice (typically 45 minutes per day, 6 days per week), and one day retreat. During the program, participants engage in a number of mindfulness practices (e.g., body scan, mindful movement, meditation) and discussions of their experiences, with the aim enhancing awareness to moment-to-moment experiences in a non-judging and accepting manner.
15954587|NCT03228732|Drug|Placebo Oral Tablet|There will be two 2-day inpatient visits with 8-weeks of treatment with placebo between those visits.
15954588|NCT03228732|Drug|Placebo Oral Tablet|There will be two 2-day inpatient visits with 8-weeks of treatment with placebo between those visits.
15954589|NCT03228732|Drug|Fluoxetine|There will be two 2-day inpatient visits with 8-weeks of treatment with fluoxetine between those visits.
15954590|NCT03228732|Drug|DHEA|There will be two 2-day inpatient visits with 8-weeks of treatment with DHEA between those visits.
15954592|NCT03228719|Behavioral|Standardize PT after TKR with a Physical Activity Intervention|Standardized PT and a physical activity intervention. Participants will be provided a FitbitTM Zip within one week after enrolling in the study. Participants will self-track their steps/day using their FitbitTM Zip. Participants ≤ 3 weeks' post-operative TKR are expected to maintain and not increase steps/day. Beyond 3 weeks after surgery, step goals will be initiated and evaluated on a weekly basis. Progression of weekly steps/day goal will be a joint decision between the participant and physical therapist. As a guide, a 10-20% increase in steps/day until at least 6,000 steps/day is achieved. Each week the physical therapist will review the participant's steps/day goal and if at least 4 of the 7 previous days per week were at or above the prior week's steps/day goal, then next week's steps/day goal will increase. The physical therapist will discuss current steps/day with the participant using the Fitbit TM Zip and set a personalized steps/day goal each week during PT.
15954593|NCT03228719|Other|Standardized PT after TKR|Participants in the control group will receive standardized PT provided by a licensed physical therapist at UDPT using the University of Delaware's Rehabilitation Guidelines for Unilateral Total Knee Replacement. Standardized PT also includes a printed home exercise program with an exercise log that is updated weekly by a physical therapist. PT appointment times range from 45-60 minutes with appointment occurring 1-3 times a week for 6-8 weeks.
15954594|NCT03228706|Behavioral|Know Your Medicine - Take It For Health (KYM-TIFH)|The KYM-TIFH employed psychosocial, educational and behavioral approach. It was designed based on the application of multiple behavior change theories and persuasion theory as recommended by Slater (1999). The cross-theoretical framework for the message design of intervention as recommended by Slater (1999) involved theories such as Transtheoretical Model (TTM) (Prochaska & Velicer 1997), Theory of Reasoned Action (TRA) (Ajzen & Fishbein 1980), Protection Motivation Theory (PMT) (Rogers 1975), Elaboration-Likelihood Model (ELM) (Petty and Cacioppo 1986) and Social Cognitive Theory (SCT) (Bandura 1992) as in Table 2. Nonetheless, the intervention embraces the philosophy of patients' empowerment, which had found to be effective in engaging patients to produce behavioral change among diabetes patients (Anderson 1995; Anderson et al 1995). Hence, the facilitators are trained to employ a non-didactic approach in facilitating the and eliciting the learning among the group members.
15954595|NCT03228693|Procedure|Biopsy and/or triamcinolone injection|Subjects will have their blood drawn during the first study visit. Subsequently, a punch biopsy and/or triamcinolone injection will be given based on group timeline.
15954596|NCT03228693|Procedure|Excisional Biopsy|Complete excision of an earlobe keloid will be taken.
15954597|NCT03228680|Drug|Follitropin delta|Single daily subcutaneous administration through pre-filled injection pen
15954598|NCT03228680|Drug|Follitropin beta|Single daily subcutaneous injection in the abdomen
15954599|NCT03228667|Drug|N-803 + Pembrolizumab|Patients will receive 200 mg pembrolizumab as an intravenous infusion over 30 minutes every three weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.
15954600|NCT03228667|Drug|N-803 + Nivolumab|Patients will receive 240 mg nivolumab as an intravenous infusion over 30 minutes every two weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.
15954601|NCT03228667|Drug|N-803 + Atezolizumab|Patients will receive 1200 mg atezolizumab as an intravenous infusion over 60 minutes every 3 weeks; if the first infusion is tolerated, subsequent infusions may be given over 30 minutes. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.
15954602|NCT03228667|Drug|N-803 + Avelumab|Patients will receive 800 mg avelumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.
15954603|NCT03228667|Drug|N-803 + Durvalumab|Patients will receive 10 mg/kg durvalumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks.
15954604|NCT03228667|Drug|N-803 + Pembrolizumab + PD-L1 t-haNK|Patients will receive 200 mg pembrolizumab as an intravenous infusion over 30 minutes every three weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at ~2 x 10^9 cells/dose weekly
15954605|NCT03228667|Drug|N-803 + Nivolumab + PD-L1 t-haNK|Patients will receive 240 mg nivolumab as an intravenous infusion over 30 minutes every two weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at ~2 x 10^9 cells/dose weekly
15954606|NCT03228667|Drug|N-803 + Atezolizumab + PD-L1 t-haNK|Patients will receive 1200 mg atezolizumab as an intravenous infusion over 60 minutes every 3 weeks; if the first infusion is tolerated, subsequent infusions may be given over 30 minutes. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at ~2 x 10^9 cells/dose weekly
15954607|NCT03228667|Drug|N-803 + Avelumab + PD-L1 t-haNK|Patients will receive 800 mg avelumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at ~2 x 10^9 cells/dose weekly
15954608|NCT03228667|Drug|N-803 + Durvalumab + PD-L1 t-haNK|Patients will receive 10 mg/kg durvalumab as an intravenous infusion over 60 minutes every 2 weeks. Patients will receive 15 µg/kg N-803 administered by subcutaneous injection every three weeks. Patients will receive PD-L1 t-haNK administered IV over 30 minutes at ~2 x 10^9 cells/dose weekly
15954609|NCT03228654|Procedure|Unipolar Electrocautery sealing of vessels|"Vaginal walls are incised by monoplar current (40 W)
~A curved Bulldog Clamp is applied just 0.5 cm lateral to the uterine border along its attachements all through the pedicles. Then unipolar electrocautery (40 W) is applied to the pedicles along the lateral border of the uterus medial to the artery with maximum thickness 1 cm.
~uterine vessels are individually secured.
~Conventional volume reduction maneuvers are used as associated procedures in cases of large uteri to create the parauterine space to approach the lateral attachements."
15954610|NCT03228654|Procedure|Purohit technique for vaginal hysterectomy|using Bipolar electrosurgical sealing of vessels during vaginal hysterctomy
15954611|NCT03228641|Device|micro-excisional skin removal with coring needle|
15954612|NCT03228628|Drug|Fixed 50:50 mixture of nitrous oxide and oxygen|Gaz inhalation will start 5 minutes before the puncture and will be continued until the end of the procedure.
15954613|NCT03228628|Other|Placebo|inhale medical air (22% O2 - 78% N2)
15954615|NCT03228602|Other|Recording of GEP (Gustatory Evoked Potentials)|record cerebral activity thanks to electrodes placed on the head and fixed with a painless, harmless adhesive paste and linked to a computer equipped with specific software to interpret the signals obtained. The collection of data for the electric signal takes 20 minutes.
15954616|NCT03228589|Dietary Supplement|probiotic strain|8 weeks of treatment with probiotic strain
15954617|NCT03228589|Dietary Supplement|Placebo|8 weeks of treatment
15954618|NCT03228576|Combination Product|Extended release Tacrolimus-Everolimus association|Envarsus® will be used as Tacrolimus Certican® will be used as Everolimus
15954619|NCT03228563|Other|Probioics|CKD Patients were supplemented with two capsules of probiotics containing 2.5*10^9 CFU Lactobacillus acidophilus (TYCA06), Bifidobacterium longum (BLI-02) and Bifidobacterium bifidum (VDD088) twice daily for 12 months.
15954620|NCT03228550|Dietary Supplement|Efamol Active 50+|1000 mg docosahexaenoic acid, 160 mg eicosapentaenoic acid, 20 µg B12, 1 mg folic acid, 124 mg phosphatidylserine, 240 mg ginkgo biloba standardized leaf extract and 20 mg vitamin E
15954621|NCT03228550|Behavioral|Aerobic exercise|Static exercise cycle
15954622|NCT03228550|Dietary Supplement|Placebo multinutrient|Placebo multinutrient supplement
15954623|NCT03228537|Drug|Atezolizumab|Given IV
15954624|NCT03228537|Drug|Cisplatin|Given IV
15954625|NCT03228537|Procedure|Extrapleural Pneumonectomy|Undergo EPP
15954626|NCT03228537|Drug|Pemetrexed Disodium|Given IV
15954627|NCT03228537|Procedure|Pleurectomy|Undergo PD
15954628|NCT03228537|Radiation|Radiation Therapy|Undergo RT
15954629|NCT03228524|Drug|D-Aspartate|Patients will be randomized to receive oral D-aspartatoe (2660 mg, once daily) or placebo,as an addition to conventional therapy as indicated by physicians, for a 6 weeks period.
15954630|NCT03228524|Behavioral|Therapeutic exercise|Standard physiotherapy
15954631|NCT03228524|Drug|Placebo Oral Tablet|Placebo
15954632|NCT03228511|Device|endoscope|It is a Prospective descriptive hospital based clinical study to determine the value of introduction of endoscope after microscopic excision of cerebello-pontine angle lesions
15954633|NCT03228498|Drug|Choline alphoscerate|Choline alphoscerate 600 mg b.i.d plus Nimodipine 30 mg t.i.d
15954634|NCT03228498|Drug|Placebo|Placebo b.i.d plus Nimodipine 30 mg t.i.d
15954635|NCT03228485|Device|MyBPH Care mobile app|The application that will give daily medication reminders and via which the questionnaires can be filled out.
15954636|NCT03228472|Device|non invasive brain stimulation|"TDCS stimulation will be administered for 5 consecutive days at 2 mA for 20 minutes.
~TMS stimulation parameters will be: 10 Hz frequency; 100% RMT intensity; Train duration 10 sec (100 stimuli); Inter-train interval 1 minute; n. Total of the terrors 12; Duration of a session about 13 minutes."
15954637|NCT03228472|Device|sham stimulation|Placebo treatment
15954638|NCT03228459|Diagnostic Test|Dried blood spot test|Dried capillary blood testing creatinine, uric acid and total cholesterol (reflotron® Plus system, Roche). Determination of the complete lipid profile in cases in which total cholesterol is greater than 200 mg/dl: HDL cholesterol (mg/dl), LDL cholesterol (mg/dl) and triglycerides (mg/dl) (Cobas B 101® system, Roche). Calculation of non-HDL cholesterol levels. Glycated haemoglobin will be analysed with the Cobas B 101 system,Roche. The CKD-EPI glomerular filtration rate will be determined.
15954639|NCT03228459|Diagnostic Test|Urine test|A urine sample from spontaneous micturition will be collected and analyzed using Clinitek Microalbumin 2 Reagent Strips and a Siemens Clinitek Status® analyzer. It will be determined albuminuria (mg/l) and albumin/creatinine ratio (mg/g).
15954640|NCT03228459|Diagnostic Test|Artery ultrasound|Carotid and femoral artery ultrasound for atheroma plaque diagnosis. Abdominal aorta ultrasound for early diagnosis of aortic aneurism. Transcranial ultrasound for cerebral arterial blood flow alterations.
15954641|NCT03228459|Diagnostic Test|Ankle-brachial index|Systolic blood pressure measurement in the brachial artery, posterior tibial artery and dorsalis pedis artery in both limbs. The ratios between tibial and pedal systolic blood pressure in each leg and the higher brachial blood pressure will be calculated.
15954642|NCT03228459|Diagnostic Test|Spirometry|Spirometry will be used to assess lung capacity. It will be performed by the same nurse who will measure forced vital capacity (FVC); forced expiratory volume in one second (FEV1); the ratio between FEV1 and FVC and the lower limit of normality, as a percentage.
15954643|NCT03228459|Diagnostic Test|Determination of advanced glycation-end products|These will be measured using skin autofluorescence (SAF) in the forearm with the AGE Reader® system (Diagnostics, the Netherlands). SAF is measured using spectrophotometry which is calculated as the relationship of the intensity of reflected light compared to refracted light.
15954644|NCT03228459|Diagnostic Test|Atrial fibrillation screening|The presence of atrial fibrillation is assessed with a device (SRA, EVINA Health Solutions) during one hour in the mobile unit.
15954645|NCT03228459|Other|Biological sample collection|Blood samples from a peripheral vein of the hand or forearm to obtain serum, plasma, DNA and RNA will be collected. Moreover, a saliva sample will be collected.These samples will be prepared in aliquots following a standardized protocol, and sent frozen (dry ice) to a centralized biobank (IRBLleida Biobank, Spain) for processing and storage for subsequent studies of CV, inflammatory and mineral-metabolism biomarkers and genetic polymorphisms. Urine samples will be frozen and stored in a biobank for subsequent study of biomarkers.
15954646|NCT03228459|Other|Result and recommendation report|A report with exploration results and recommendations based on the current guidelines will be uploaded to the e-CAP history for the Primary care evaluation.
15954647|NCT03228459|Diagnostic Test|Pulse wave velocity|Pulse wave velocity (PWV) will be used as an indicator of arterial stiffness. It will be measured non-invasively with the carotid to femoral PWV (cfPWV) according to standard protocols.
15954648|NCT03228446|Behavioral|filter training|one-week filter training on the computer: computerized visual change detection experiment (selective attention )
15954649|NCT03228446|Behavioral|memory training|one-week storage training on the computer: computerized visual change detection experiment (memory storage)
15954650|NCT03228446|Other|no training (control)|no training applied
15954651|NCT03228433|Drug|TAK-418|TAK-418 Capsule.
15954652|NCT03228433|Drug|TAK-418 Placebo|TAK-418 placebo-matching capsules.
15954653|NCT03228420|Device|Senza HF10 Therapy|Senza 10kHz Spinal Cord Stimulation
15954654|NCT03228420|Other|CMM|Conventional Medical Management
15954655|NCT03228407|Procedure|Confocal endomicroscopy|Confocal laser endomicroscopy (CLE) permits real-time in-vivo histologic analysis of esophageal mucosa at the time of upper endoscopy. The technology is based on the principle of illuminating a tissue with a low-power laser and then detecting fluorescent light reflected from the tissue. Because CLE relies upon tissue fluorescence, intravenous fluorescein is generally used to highlight the vasculature and intercellular spaces of the tissue being examined.
15954656|NCT03228407|Diagnostic Test|Endoscopic biopsies|Additional biopsies will be obtained of the esophageal mucosa.These will be obtained with a standard biopsy forceps inserted through the channel in gastroscope.
15954657|NCT03228407|Diagnostic Test|Mucosal impedance (MI)|MI balloon measures epithelial impedance along a 10 cm length of esophagus. The gastroscope will be withdrawn and the MI balloon will be advanced into the esophagus through the mouth. The balloon will be inflated so that the sensors contact the esophageal mucosa. After MI measurements are obtained, the balloon will be deflated and withdrawn.
15954658|NCT03228394|Drug|Ganaxolone|Ganaxolone IV
15954659|NCT03228394|Drug|Placebo|Placebo IV
15954660|NCT03228381|Device|BOSS Device|The BOSS will be comprised of a flexible, medical grade silicone handle and interchangeable inflatable medical grade silicone chambers. The inflatable chambers will vary in geometry and will have silicone tubing attached to them to allow inflation and deflation of the chamber while in the pericardial space. During open chest cardiac surgery, a small incision will be made in the pericardium to allow for insertion of the BOSS device into the pericardial space. Once inserted, the BOSS device will be positioned in different locations around the outside of the heart and anatomical and geometric changes will be observed echocardiographically. Use of the BOSS device is expected to lengthen the procedure by an average of 15 minutes, and in rare instances may be extended beyond 15 minutes as deemed appropriate by the investigator. The BOSS will be removed prior to continuing with the planned surgery.
15954661|NCT03228368|Drug|Atezolizumab (MPDL3280A)|anti-programmed death-ligand 1 (PD-L1) antibody
15954662|NCT03228355|Drug|Levcromakalim|To investigate the role of Levcromakalim on cerebral hemodynamic in migraine patients
15954663|NCT03228355|Drug|Saline|To investigate the role of levcromakalim compared with saline cerebral hemodynamic in migraine patients.
15954664|NCT03228342|Diagnostic Test|MusculoSkeletal Ultrasound|"Patient will be assess with ultrasound (GUS-7 score) and the results will be informed to his/her attending Rheumatologist.
~The Patient Reported Outcomes will be evaluated a 0,6 and 12 months after randomization."
15954665|NCT03228342|Diagnostic Test|MusculoSkeletal Ultrasound|"Patient will be assess with ultrasound (GUS-7 score) and the results will not be informed to his/her attending Rheumatologist.
~The Patient Reported Outcomes will be evaluated a 0,6 and 12 months after randomization."
15954666|NCT03228329|Other|fluid boluses|fluid boluses will be given when there will be hypovolemia assessed by presence of pulse pressure variations
15954667|NCT03228316|Procedure|superior hypogastric plexus block|nerve plexus block
15954668|NCT03228316|Radiation|pulsed radiofrequency|pulsed radiofrequency on sacral nerve roots 2,3 and 4
15954669|NCT03228303|Drug|Nilotinib 150 MG [Tasigna]|Nilotinib vs imatinib in patients with newly diagnosed CML-CP
15954670|NCT03228303|Drug|Imatinib 400mg|Nilotinib vs imatinib in patients with newly diagnosed CML-CP
15954671|NCT03228277|Drug|Olmutinib|Patients to be provided with Olmutinib 800mg (2 x 400 mg tablets) once daily (QD)
15954672|NCT03228264|Device|teleSLT|The teleSLT intervention consists of a daily training session with a tablet computer at the patients' home. The teleSLT application that will be used for this study was developed within a multidisciplinary team of speech and language therapists, neurologists and computer engineers that have transferred well-established SLT exercises to a tablet computer. The investigators call this application Bern Aphasia App (BAA). During the four weeks the training time with the BAA differs between the two arms. The experimental group trains for 96 minutes per day (80% of two hours) and the control group for 24 minutes per day (20% of two hours).
15954673|NCT03228264|Device|teleCT|For the cognitive training the investigators will use two custom-made versions of popular commercial casual puzzle video games: Flow Free (Big Duck Games LCC) and Bejeweled (PopCap Games). The video games are also delivered on tablet-computers. Again, during the four weeks the training time differs between the two arms. The experimental group trains for 24 minutes and the control group for 96 minutes per day.
15954674|NCT03228251|Other|Stroke team simulation training|"The participating centers identify 3-4 senior staff of different professional backgrounds (e.g. senior neurologist, neurointerventionalist, head nurse) who will design a stroke team algorithm tailored to the local circumstances of the stroke center. The centers will be invited to a joint train-the-trainer seminar at the sponsor's institution where they present their algorithm to the participants of all seven stroke centers for discussion to invite suggestions for streamlining and improvement. The teams will be introduced to the concept of simulation-based stroke team training. After the seminar, the principal investigator and the stroke team trainer will visit all centers for one on-site stroke team training and provide teaching materials. Afterwards, each center will be invited to schedule two additional stroke team trainings with the stroke team trainer that will be led by e.g. the senior neurologist from the stroke unit with use of a simulation manikin."
15954675|NCT03228238|Drug|Vitamin C and Vitamin E|Ascorbic acid Tablet 1g and Tocopherol Capsule 400IU
15954676|NCT03228238|Drug|Statin|Atorvastatin calcium 10mg
15954677|NCT03228238|Drug|Standard medication for variant angina|Calcium Channel blocker or NG
15954678|NCT03228225|Behavioral|Tele Cardiac Rehabilitation|Comprehensive intervention according to the secondary prevention goals
15954679|NCT03228212|Device|CONTROL|ACUVUE OASYS
15954680|NCT03228212|Device|TEST|senofilcon A with new UV blocker
15954681|NCT03228199|Other|Intervention group|Will immediately receive a free pair of presbyopic glasses through the Clear Vision Workplace program. These glasses will correct the worker's vision at their usual working distance, and will not correct astigmatism.
15954682|NCT03228199|Other|Control Group|Will be deferred to receive spectacles as above, after the 12 week evaluation period.
15954683|NCT03228186|Drug|Pevonedistat|25mg/m2 days 1, 3, 5
15954684|NCT03228186|Drug|Docetaxel|75mg/m2 day 1
15954757|NCT03227679|Other|Nicotine Metabolite Ratio|This intervention used information from a genetically-informed biomarker (Nicotine Metabolite Ratio, NMR) to assign one of 3 FDA-approved smoking cessation pharmacotherapies (varenicline, bupropion, or NRT) to participants.
15954685|NCT03228160|Other|Linearly Polarized Near-Infrared light Irradiation|The SGI was carried out with the use of a linear-polarized near-infrared irradiation device, Minato Alphabeam Infrared Ray Therapy Unit (Minato Medical Science Co., Ltd., Hyogo, Japan), by a senior physical therapist. The maximum output was 3000 mW/cm² at wavelengths of 0.7 to 1.6 m-⁶, including a combination of red and near-infrared radiation. All patients in the experimental group received SGI under the conditions as follows: output, 90%; irradiation circle 1:2 (irradiation 3 seconds followed by 7-seconds pause); duration of irradiation, 10 min; and total irradiation energy density, 194.8 J/cm². The instrument in the control group with shame irradiation was the same as that in the experimental group with the exception that emitted radiation from device was inactive.
15954686|NCT03228147|Dietary Supplement|Nutritional Supplementation|Given PO
15954687|NCT03228147|Other|Questionnaire Administration|Ancillary studies
15954688|NCT03228134|Drug|Ke Chuan Liu Wei Granule|Traditional Chinese Medicine
15954689|NCT03228134|Drug|Yang He Ping Chuan Granule|Traditional Chinese Medicine
15954690|NCT03228134|Other|Ke Chuan Liu Wei Granule placebo|Placebo
15954691|NCT03228134|Other|Yang He Ping Chuan Granule placebo|Placebo
15954692|NCT03228121|Procedure|Treatment Then Placebo|Cohort A will receive stem cells/PRP infusion during round one then placebo of normal saline infusion during round two.
15954693|NCT03228121|Procedure|Placebo Then Treatment|Cohort B will receive placebo of normal saline infusion during round one then stem cells/PRP infusion during round two.
15954694|NCT03228108|Drug|Ciprofloxacin|see study arms.
15954695|NCT03228108|Drug|Trimethoprim/Sulfamethoxazole|see study arms.
15954696|NCT03228108|Drug|Fosfomycin|see study arms.
15954697|NCT03228108|Drug|Pivmecillinam/augmentin|see study arms.
15954698|NCT03228095|Diagnostic Test|VOC detection in breath and in skin headspace|VOC will be detected in breath with off-line and on-line testing and in skin headspace with off-line testing
15954699|NCT03228095|Diagnostic Test|Breath sampling|Breath sampling for VOCs detections will be carried out using nano-sensor based devices (electronic nose)
15954700|NCT03228095|Procedure|Upper endoscopy with biopsies|Upper endoscopy with proper biopsy work-up will be used for identification and stratification of gastric lesions as well as acquisition of biopsies for microbiota testing
15954701|NCT03228095|Procedure|Colonoscopy with biopsies|Colonoscopy with proper biopsy or polypectomy material work-up will be used for identification and stratification of colorectal lesions as well as acquisition of biopsies for microbiota testing
15954702|NCT03228095|Procedure|Whole blood/ Plasma / serum sampling|Whole blood/Plasma/serum sampling will be used to obtain information for group stratification
15954703|NCT03228095|Diagnostic Test|Faecal sampling|Facal samples will be obtained for faecal occult blood testing as well as microbiota analysis
15954704|NCT03228095|Procedure|Histological examination of surgical specimen|Routine histological exam for patients undergoing curative or palliative surgery. Indication for surgery are set based on underlying condition. Study does not interfere with decision making for surgical treatment
15954705|NCT03228095|Diagnostic Test|Headspace analysis for biological material|VOC analysis from headspace of surgical specimen, biopsy materials, blood/plasma, microbiota etc.
15954706|NCT03228082|Device|Home Blood Pressure Monitoring (HBPM)|Home blood pressure monitoring using the Withings Wireless BP monitor. Patients will be asked to measure their blood pressure twice daily for 7 consecutive days. This will be repeated for every month for 1 year.
15954707|NCT03228069|Procedure|Blood drawn after rabies booster vaccination|Blood would be drawn for testing of rabies neutralizing antibody titers, rabies specific T lymphocytes and regulatory T cells after receipt of rabies booster vaccination at least a year before.
15954708|NCT03228056|Diagnostic Test|pain intensity measured in VAS scale|Pain intensity in 0-100 mm VAS scale is measured every 4 hours on standard ruler beginning from the end of the surgery.
15954709|NCT03228043|Drug|Apatinib|Apatinib combine with CAPEOX adjuvant chemotherapy for resectable colorectal
15954710|NCT03228043|Drug|CAPEOX|CAPEOX adjuvant chemotherapy for resectable colorectal
15954711|NCT03228030|Dietary Supplement|Thiamine|Capsules
15954712|NCT03228030|Dietary Supplement|Placebo|Identical capsules
15954713|NCT03228017|Drug|Aspirin and/or Atorvastatin|This follow-up will allow us to assess how aspirin and/or atorvastatin affect platelet and endothelial function and inflammation.
15954714|NCT03228004|Behavioral|Glooko MeterSync|The participant and caregiver will receive a reminder via text or email to upload glucose data via Glooko on a biweekly basis.
15954715|NCT03227991|Behavioral|Safety Planning Intervention|The Safety Planning Intervention is a protocol driven, brief suicide prevention strategy that is a good fit for acute care settings. It involves a clinician working collaboratively with the patient to build a personalized safety plan that is documented using a templated paper form and includes warning sign identification, means restriction and personalized strategies to deescalate a suicide crisis.
15954716|NCT03227991|Behavioral|Risk factors and Warning signs|Printed information sheet listing suicide risk factors and crisis hotlines
15954717|NCT03227978|Combination Product|PCL mesh pleurodesis|Coverage of the lung surface by PCL mesh
15954718|NCT03227965|Biological|Immune cells population assesment|T lymphocytes population description through blood, urine and faeces samples
15954719|NCT03227952|Device|Vibrotactile stimulation|Vibrotactile sensory stimulation will consist on whole-body stimulation with mechanical stimuli of pallesthetic type at high rate (20-90 Hz), low intensity and long daily duration (3h).
15954720|NCT03227939|Procedure|Laparoscopic sleeve gastrectomy（LSG）|LSG：All these operations were performed by the same surgeon team. Dissect the greater omentum alongside the greater gastric curvature, make sure that the greater gastric curvature and fundus of stomach were completely made free from pancreas and spleen.Fully Exposed left and right diaphragm angle and taking care not to injure the esophagus. Resection was started 2 to 4 cm from pylorus and alongside a 40Fr tube up to the esophagogastric junction and created a 60 to 80ml gastric lumen, removed the fundus of stomach thoroughly and take care of the esophagus and preventriculus. Repaired the hiatal hernia if it was exsit.
15954758|NCT03227679|Drug|Varenicline|FDA-approved smoking cessation pharmacotherapy
15954759|NCT03227679|Drug|Bupropion|FDA-approved smoking cessation pharmacotherapy
15954760|NCT03227679|Drug|Nicotine patch|FDA-approved smoking cessation pharmacotherapy
15954721|NCT03227939|Procedure|Uvulopalatopharyngoplasty(UPPP) and Adenoidectomy/Tonsillectomy|UPPP：PPP is typically administered to patients with obstructive sleep apnea in isolation. It is administered as a stand-alone procedure in the hope that the tissue which obstructs the patient's airway is localized in the back of the throat. The rationale is that, by removing the tissue, the patient's airway will be wider and breathing will become easier.
15954722|NCT03227926|Drug|Panitumumab 20 MG/ML Intravenous Solution [VECTIBIX]|Panitumumab 6 mg/kg in 100 cc 0.9% NaCl solution on Day 1 every two weeks by IV administration over 1 hour.
15954723|NCT03227926|Diagnostic Test|Molecular Screening|Patients without plasmatic evidence of potentially resistant clones harbouring RAS or EGFR-ectodomain mutations in the RML liquid biopsy, will be molecular eligible for the trial phase
15954724|NCT03227913|Other|Two samples of saliva|"Without stimulation: the first will be used to measure the flow of naturally secreted saliva
~With stimulation: the second will will be used to measure the flow and viscosity of the saliva secreted after stimulation"
15954725|NCT03227913|Other|Chewing behaviour|Measure the time taken by subjects to chew the food and the number of bites they use before swallowing
15954726|NCT03227913|Other|Study of the food bolus|"Analysis by a compression and viscosity test
~Evaluation of the quantity of saliva incorporated by drying"
15954727|NCT03227900|Drug|Lidocaine|Intragastric infusion of lidocain
15954728|NCT03227900|Drug|Placebos|Intragastric infusion of water for injections
15954729|NCT03227887|Other|Two samples of saliva|"Without stimulation : the 1st will be used to measure the flow of naturally secreted saliva
~With stimulation: The 2nd will be used to measure the flow and viscosity of the saliva secreted after stimulation"
15954730|NCT03227887|Other|Chewing behaviour|Measure the time taken by the subjects to chew the food and the number of bites they use before swallowing The test will be done twice.
15954731|NCT03227887|Other|Study of the food bolus|"2 tests:
~Evaluate using a compression test the structure of each bolus to determine their degree of destructuration over time Measure the quantity of the saliva incorporated
~The bolus will be analysed visually"
15954732|NCT03227887|Other|Mouthfeel|Describe the mouthfeel by answering a paper questionnaire after consumption of the cereal products
15954733|NCT03227874|Dietary Supplement|Dried apple|diced dried apple with 55 g carbohydrate, was consumed by the participants with 220 ml of water.
15954734|NCT03227874|Dietary Supplement|Muffin|two muffins with 55 g carbohydrate, was consumed by the participants with 220 ml of water.
15954735|NCT03227861|Drug|DRV 800 mg + COBI 150 mg + FTC 200 mg + TAF 10 mg FDC|Participants will receive oral tablet containing D 800 mg /C 150 mg /F 200 mg /TAF 10 mg FDC once daily within 24 hours of the screening/ baseline visit.
15954736|NCT03227848|Device|Automated Heart Murmur Detection AI|Automated AI algorithm-based analysis of digital heart sound recordings to detect and classify heart murmurs. Heart sound recordings were fully blinded before undergoing one-time automated analysis. AI algorithm results for each recording include: AHA classification (Class I (pathologic heart murmur) versus class III (innocent heart murmur or no heart murmur), murmur timing, murmur grade, heart rate and S1/S2 identification.
15954737|NCT03227835|Other|intravascular iodinated contrast material administration|Evaluation of the consequences of the protocol change to not giving prophylaxis to patients with an eGFR >29mL/min/1.73m2
15954738|NCT03227822|Procedure|Short spot stenting|
15954739|NCT03227822|Procedure|Long lesion stenting|
15954740|NCT03227809|Behavioral|Handbook condition|Parents of first-year university students receive parent handbook summer before start of university. Handbook contains suggestions for activities and conversations parents can conduct with students.
15954741|NCT03227809|Behavioral|Handbook plus condition|Parents of first-year university students receive parent handbook summer before start of university. Handbook contains suggestions for activities and conversations parents can conduct with students. Parent also receive text messages throughout the year.
15954742|NCT03227796|Drug|LEVI-04|LEVI-04 intravenous infusion
15954743|NCT03227796|Drug|Placebo|Placebo intravenous infusion
15954744|NCT03227783|Device|transcranial direct current stimulation (tDCS)|tDCS is one of non-invasive brain stimulation. Constant, low current is delivered to the specific brain areas to change brain plasticity.
15954745|NCT03227770|Device|hemoperfusion combined with hemodialysis|Hemoperfusion combined with hemodialysis treatment will perform once every two week. The hemoperfusion apparatus will use type HA130 resin hemoperfusion apparatus (Zhuhai Jafron Biomedical Co., Ltd, China)
15954746|NCT03227770|Device|hemodialysis|Low-flux hemodialysis treatment at a frequency of 2 times a week and online-hemodiafiltration treatment at a frequency of once a week, with each treatment session lasting 4 hours.
15954748|NCT03227744|Behavioral|Group therapy|Twelve 1-hour group therapy sessions with a licensed psychologist for prostate-cancer related anxiety.
15954749|NCT03227744|Other|Surveys|MAX-PC, GAD and FACT-P
15954750|NCT03227731|Drug|Truvada|Truvada (Truvada (emtricitabine 200mg/tenofovir disoproxil fumarate 300mg) is in a fixed-dose combination (FDC) tablet formulation and is proven safe for the prevention and treatment of HIV in non-pregnant and non-lactating women.
15954751|NCT03227718|Behavioral|VOR and coordination measurements|measurement of VOR and VOR suppression in addition to hand-eye coordination tasks
15954752|NCT03227705|Drug|Prometrium|Intravaginal use, off label, of Prometrium
15954753|NCT03227705|Device|Dr. Arabin, cerclage pessary perforated|A Dr. Arabin, cerclage pessary perforated will be inserted participants diagnosed with a short cervix
15954754|NCT03227692|Device|Persona Knee System|Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.
15954755|NCT03227692|Procedure|Total Knee Arthroplasty|Damaged cartilage due to degerative arthritis is replaced by knee joint prosthesis.
15954756|NCT03227692|Device|iAssist Knee|Osteotomy of TKA is navigated by iAssist system, iAssist requires pin inserted in bone.
15954761|NCT03227666|Behavioral|Exercise|The intervention group will perform three supervised group training sessions a week, consisting of 30 minutes of balance training for 4 weeks.
15954763|NCT03227653|Drug|Nevirapine|Weight-based dosing according to the National Guidelines for the Management of HIV and AIDS
15954764|NCT03227653|Drug|Lopinavir-Ritonavir Drug Combination|Weight-based dosing according to the National Guidelines for the Management of HIV and AIDS
15954765|NCT03227640|Procedure|stripping technique|The cyst is stripped from the healthy ovary by traction and countertraction; after the removal of the cyst, hemostasis is achieved by selective bipolar coagulation.
15954766|NCT03227640|Device|CO2 laser (AcuPulse Duo, Lumenis)|The cyst content is drained and the internal wall is vaporized with CO2 laser beam (AcuPulse Duo, Lumenis, Israel)
15954767|NCT03227627|Device|VitalStim|One group of children (Group A) will receive 24 sessions of NMES for combined with traditional therapy including oral motor exercises and laryngeal exercises will be performed to the participants. The equipment to be used for NMES is VitalStim®. VitalStim is a product of Empi®.
15954768|NCT03227627|Other|Traditional Therapy|The other group (Group B) will be receiving 24 sessions of traditional dysphagia therapy.
15954769|NCT03227614|Behavioral|Support Person Intervention|The patient participant will have a support person of her choice accompany her during her abortion procedure.
15954770|NCT03227601|Device|posture adapter|continued use of the device at home for 2 months after instructions of how to do it
15954771|NCT03227588|Diagnostic Test|Fractional Flow Reserve|This is a prospective data collection study for patients that have undergone FFR.
15954772|NCT03227575|Behavioral|Exercise Intervention|The use of exercise to improve glycemic responses in young adults who are at risk for Metabolic Syndrome.
15954773|NCT03227562|Drug|RisperiDONE 0.5 MG|To be prescribed a 0.5mg risperidone treatment for anxiety is required to be enrolled.
15954774|NCT03227549|Procedure|Direct Superior Approach|Total hip arthroplasty using direct superior approach
15954775|NCT03227549|Device|Total Hip Arthroplasty|Total Hip Arthroplasty using direct superior or posterior approach
15954776|NCT03227549|Procedure|Posterior Approach|Total Hip Arthroplasty using posterior approach
15954777|NCT03227497|Dietary Supplement|Whole Walnuts|Intervention arm includes whole walnuts taken as dietary replacement meal during the day, and between breakfast and lunch, and/or lunch and dinner. Importantly, none of the main meals, including breakfast, lunch and dinner are to be replaced by study intervention, and the study subjects are instructed to do so. Walnuts are provided with the same producer at the Belgrade market.
15954778|NCT03227484|Drug|Empagliflozin 25mg|Once daily over 8 weeks
15954779|NCT03227484|Drug|Placebo Oral Tablet|Once daily over 8 weeks
15954780|NCT03227471|Drug|IVA|150-mg IVA film-coated tablet for oral administration
15954781|NCT03227471|Drug|TEZ/IVA|100-mg TEZ / 150-mg IVA fixed dose combination (FDC) tablet for oral administration.
15954782|NCT03227471|Drug|VX-445|VX-445 tablet for oral administration.
15954783|NCT03227471|Drug|Matched Placebo|Matched placebo.
15954784|NCT03227471|Drug|TEZ|50-mg tablet for oral administration.
15954785|NCT03227471|Drug|VX-561|50-mg tablet for oral administration.
15954786|NCT03227458|Other|DHEA|Participants will take 1 study pill (50 mg DHEA) daily for 36 weeks.
15954787|NCT03227458|Other|Placebo|Participants will take placebo daily for 36 weeks.
15954788|NCT03227458|Behavioral|Exercise|bone-loading exercise on 3 days per week for 38 weeks
15954789|NCT03227445|Device|ELLIPTA placebo DPI|ELLIPTA is a dry powder inhaler used via oral route. It will be a placebo DPI with two strips with 30 blisters per strip. First strip will contain lactose monohydrate and the second strip will contain lactose monohydrate blended with magnesium stearate.
15954790|NCT03227445|Device|DISKUS placebo DPI|DISKUS is a dry powder inhaler used via oral route. It will be a placebo DPI with one blister strip that will contain lactose monohydrate.
15954791|NCT03227445|Device|HandiHaler placebo DPI|HandiHaler is a dry powder inhaler used via oral route. It will be a DPI with placebo capsules that will contain lactose monohydrate.
15954792|NCT03227445|Other|Inhaler preference questionnaires|Preference questionnaires will be given to subjects to understand the inhaler preference. There will be 2 types of questionnaire, preference questionnaires 1 and 2, which will be randomized at visit 3 (Day 56).
15954793|NCT03227432|Drug|Dexamethasone|Dexamethasone, a corticosteroid, is similar to a natural hormone produced by adrenal glands. It relieves inflammation.
15954794|NCT03227432|Drug|Pomalidomide|Pomalidomide which is an immunomodulatory drug. This means that pomalidomide modulates the immune system to help fight diseases.
15954795|NCT03227432|Drug|Elotuzumab|Elotuzumab is an antibody, that stimulates the immune system to fight diseases
15954796|NCT03227432|Drug|Nivolumab|Nivolumab works by blocking an inhibitory signal within immune cells, potentially allowing the immune system to fight the cancer
15954797|NCT03227419|Drug|Tocilizumab Prefilled Syringe|"Treatment arm: tocilizumab (RoActemra®):
~162 mg weekly a schema for therapeutic adaptation with injection intervals determined according to transaminase levels or blood cell counts (neutropenia, thrombopenia) as recommended by Roche-Chugaï (see table below)."
15954798|NCT03227419|Drug|Abatacept Prefilled Syringe|"Treatment arm: abatacept (Orencia®)
~125 mg weekly after an initial dose of 500 mg (body weight <60kg), 750 mg (body weight between 60 and 100 kg), or 1000 mg (body weight >100 mg) 24 hours before the first subcutaneous injection."
15954799|NCT03227406|Behavioral|Sleep deprivation|Subjects are kept awake all night.
15954800|NCT03227406|Behavioral|Nap|Participants are given a 90-minute nap opportunity in the early afternoon.
15954801|NCT03227393|Behavioral|Yoga training|Subjects will complete in class yoga training weekly for 8 weeks with additional practice at home
15954802|NCT03227380|Other|thoracic densitometry with contrast|injected CT scan at 3 or 6 months after segmentectomy VATS
15954803|NCT03227367|Other|other : PRF|mononuclear cells from the peripheral blood of chronic periodontitis patients were intervened with PRF, BCP and PRF/BCP combination
15954804|NCT03227354|Device|Vittamed 205|non-invasive Intracranial Pressure measurement
15954805|NCT03227341|Other|Exercise|8 week exercise program including breathing exercises consisted of pursed-lip breathing, diaphragmatic breathing and thoracic expansion exercises, relaxation and stretching exercises, upper and lower extremity muscle strength training, and aerobic exercises. In addition, bronchial hygiene techniques and dyspnea-reducing positions
15954844|NCT03226964|Device|high flow nasal oxygen|humidified high flow nasal oxygen
15954806|NCT03227328|Drug|concomitant cyclin-dependent Kinase 4/6 (CDK4/6) inhibitor plus endocrine therapy|"CDK4/6 inhibitor:
~palbociclib
~ribociclib
~abemaciclib
~Endocrine therapy:
~non-steroidal or steroidal AI
~fulvestrant"
15954807|NCT03227328|Drug|chemotherapy plus endocrine therapy (administered either concomitantly or sequentially)|"Standard Chemotherapy regimens will be classified as:
~anthracycline + taxane,
~taxane,
~anthracycline,
~capecitabine / fluoropyrimidines,
~others.
~Endocrine therapy:
~non-steroidal or steroidal AI
~fulvestrant"
15954808|NCT03227302|Procedure|attending obstetrician|Attending obstetrician can do the caesarean operation without pregnant complications.
15954809|NCT03227302|Procedure|associate obstetrician|Associate chief Obstetrician can do the caesarean operation without or mild or middle pregnant complications.
15954810|NCT03227302|Procedure|chief obstetrician|Chief obstetrician can do all caesarean operation without limitations.
15954811|NCT03227289|Other|Stayed in NRDS|The neonates with NRDS are stayed in NRDS.
15954812|NCT03227289|Other|Converted to ARDS|The neonates with NRDS are converted to ARDS.
15954813|NCT03227276|Dietary Supplement|Litramine|2 tablets to be taken 3 times a day after meals
15954814|NCT03227276|Dietary Supplement|Placebo tablet|2 tablets to be taken 3 times a day after meals
15954817|NCT03227224|Drug|Placebo|Participants will receive 2 placebo capsules matching JNJ-42847922 once daily orally from Day 1 to Day 41 (Week 6).
15954818|NCT03227224|Drug|JNJ-42847922|Participants will receive 2 capsules of JNJ-42847922 once daily orally from Day 1 to Day 41 (Week 6).
15954819|NCT03227198|Biological|Intramyocardial injection of stem cell|Autologous bone marrow-derived mononuclear cells are obtained from 100-150ml of bone marrow aspirated under local anaesthesia from the iliac crest. Intramyocardial injection of the cells is performed in patients with Heart failure in open heart surgery (CABG)
15954820|NCT03227198|Biological|Placebo|Injection of Placebo in patients with Heart failure in open heart surgery (CABG)
15954821|NCT03227185|Device|real anodal transcranial direct current stimulation (tDCS)|The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used in the study.
15954822|NCT03227185|Device|sham transcranial direct current stimulation (tDCS)|The MR-compatible neuroConn DC-Stimulator MR (neuroCare Group, Ilmenau, Germany) will be used in the study.
15954823|NCT03227172|Procedure|apicoectomy|After flap elevation and osteotomy , peri-apical lesion and the root tip were located: after root-end resection using a fissure bur, the resected root tip and the pathological tissue were removed and immediately preserved in 1% formaldehyde solution.
15954824|NCT03227146|Biological|EHSG-KF|Transplantation of autologous dermo-epidermal skin substitute EHSG-KF to the experimental area
15954825|NCT03227146|Biological|STSG|Transplantation of autologous split-thickness skin graft to the control area
15954826|NCT03227133|Other|Neuropsychological evaluations|Neuropsychological evaluations including oral fluency, performed specifically for the study
15954827|NCT03227133|Other|Psychiatric interview|
15954828|NCT03227133|Other|Cardiovascular risk assessment|
15954829|NCT03227120|Other|Prehabilitation exercise|"Three times weekly exercise program of strengthening, balance and functional activities.
~Weekly evaluation and progression with daily use of the Borg Rating of Perceived Exertion (RPE) supplemented with Heart Rate (HR) and Blood Pressure as needed to target the moderate intensity training level (40-60% HR Max) or above as appropriate to each individual."
15954830|NCT03227094|Diagnostic Test|Standard OGTT|Standard-OGTT Plasma glucose : 0, 30, 60, 90, 120 minutes Complete biochemical profile, weight and size (body mass index), drugs list, pulmonary function by spirometry (FEV, etc.) Questionnaires CGMS training & delivery of Jelly-Bean/75g glucose beverage
15954831|NCT03227094|Diagnostic Test|Home-based OGTT (Beverage)|In a random order Candy-OGTT (Jelly-Bean) or 75 g glucose beverage Glycemia every 15 minutes from CGMS collection; standardized condition (fasting + rest) Questionnaires
15954832|NCT03227094|Diagnostic Test|Home-based OGTT (Candy)|In a random order Candy-OGTT (Jelly-Bean) or 75 g glucose beverage Glycemia every 15 minutes from CGMS collection; standardized condition (fasting + rest) Questionnaires
15954833|NCT03227081|Behavioral|Sleep Deprivation|Sleep Deprivation
15954834|NCT03227068|Other|PEDSS - symptom management|All subjects will receive education regarding their specific disease and treatment in accordance with current practices. Cancer care providers describe detailed side effects of treatment to parents during the treatment consent process. In addition, all parents will receive standard discharge education before hospital discharge, which includes a list of home medications and information regarding whom to call for emergencies. The PEDSS - symptom management will be delivered prior to the initial hospital discharge. The nurse will review the symptom management worksheet verbally with the parent, then distribute the written worksheet to the parent.
15954835|NCT03227068|Other|PEDSS - support for the caregiver|All subjects will receive education regarding their specific disease and treatment in accordance with current practices. Cancer care providers describe detailed side effects of treatment to parents during the treatment consent process. In addition, all parents will receive standard discharge education before hospital discharge, which includes a list of home medications and information regarding whom to call for emergencies. The PEDSS - support for the caregiver will be delivered prior to the initial hospital discharge. The nurse will review the worksheet verbally with the parent, then distribute the written worksheet to the parent.
15954836|NCT03227029|Biological|RSV ΔNS2/Δ1313/I1314L|10^6 plaque-forming units (PFU); administered as nose drops
15954837|NCT03227029|Biological|RSV 276|10^5 PFU; administered as nose drops
15954838|NCT03227029|Biological|Placebo|Isotonic diluent, administered as nose drops
15954839|NCT03227016|Drug|veliparib|Topotecan at increasing doses (1x or 2x per day) will be administered in each cycle.
15954840|NCT03227016|Drug|Topotecan|Topotecan at dose 1.25 mg/m2 will be administered in each cycle.
15954841|NCT03226990|Other|impression technique|impression technique with and without wax spacer
15954842|NCT03226977|Device|NIPPV|NIPPV is used as a primary mode of ventilation in premature infants with respiratory distress syndrome
15954843|NCT03226977|Device|NCPAP|NCPAP is used as a primary mode of ventilation in premature infants with respiratory distress syndrome
15954845|NCT03226951|Device|Subthreshold 532nm laser|Subthershold 532nm laser
15954846|NCT03226925|Diagnostic Test|Non-invasive mechanically-assisted ventilation|Mechanically ventilation will be done through facial masks connected to a respirator. Volunteers/patients are fully conscious during the ventilation.
15954847|NCT03226925|Diagnostic Test|Dynamic MRI acquisition|Dynamic MRI acquisition are specific dynamic sequences intended to visualise the motion of internal structures (anatomical structures or tumour) under non-invasive mechanically-assisted ventilation
15954848|NCT03226925|Diagnostic Test|Planning 4D-CT|In order to perform in-silico planning, 4D-CT will be acquired on patients under non-invasive mechanically-assisted ventilation
15954849|NCT03226899|Drug|Lesinurad|200 MG Oral Tablet
15954850|NCT03226899|Drug|XOI|All participants must be on a stable, medically appropriate dose of XOI as their sole urate-lowering therapy (ULT) indicated for the treatment of gout for at least 4 weeks prior to Screening and throughout the Screening Period. This stable dose of XOI will be maintained throughout the study period.
15954851|NCT03226899|Drug|Placebo|matching placebo oral tablet
15954852|NCT03226873|Behavioral|Peer Navigation|Peer education, counseling, and facilitation of PrEP care
15954853|NCT03226860|Device|Gait Myoelectric Stimulator|Electrical stimulation during gait for children with CP
15954854|NCT03226860|Other|5210|Children will eat 5 fruits/vegetables each day, watch 2 hours or less of screen time, perform 1 hour or more of physical activity, and drink 0 sugar-sweetened beverages.
15954855|NCT03226847|Procedure|Pulmonary Vein Isolation|Standard antral pulmonary vein isolation using radiofrequency ablation catheters
15954856|NCT03226834|Device|MUSIC CARE|Musicotherapy session using one of the U musical sequences of MUSIC CARE among the preselected music styles
15954857|NCT03226834|Other|PERSONAL PLAY-LIST|Musicotherapy session using the patient's play-list composed by the patient with her favourite songs
15954858|NCT03226821|Drug|Tesamorelin|Patients will be treated with tesamorelin 2 mg by subcutaneous injection daily
15954859|NCT03226808|Device|Vivacit-E Liner|All subjects enrolled will receive the Vivacit-E liner.
15954860|NCT03226795|Other|" Information-Motivation-Behavioral skills  intervention."|"information -> Reminders of medication: mobile application
~Motivation -> Coaching by patients: intervention or coaching by an expert patient, animation of a social network of patients
~Behavioral skills -> Accompaniment by professionals: therapeutic education, assessment of membership during medical visits, prioritization of treatments"
15954861|NCT03226782|Other|Short intervention protocol|Will be offered an instructional material that will consist of a routine of 12 exercises to be performed autonomously for range of motion and muscular fitness, using the environmental resources of the home. It will be suggested a daily frequency in the execution of this exercise routine. Also, stimuli and guidelines will be given for the practice of active movement (walking) so that they accumulate at least 10 to 20 minutes of this activity daily. All control and training guidelines for using the manual will be offered through an introductory lecture and subsequent weekly telephone contacts (twice a week). Participants should complete their respective program for a total period of 12 weeks and mark in the manual how often they performed the exercises.
15954862|NCT03226782|Other|Long intervention protocol|This Manual guides its implementation in a progressive way and at the end it totals about 30 to 45 min of physical exercises per day. All control and training guidelines for use of the manual will be offered through an introductory lecture and subsequent weekly telephone contacts (twice a week). Participants should complete their respective program for a total period of 12 weeks and mark in the manual how often they performed the exercises. Therefore, it guides the implementation of daily walks with cumulative effect.
15954863|NCT03226769|Device|TrueTear™|Intranasal application of TrueTear™ device for approximately 8 minutes at Day 0, for approximately 3 minutes at Day 7 and then daily use of TrueTear™ per participant guide.
15954864|NCT03226769|Device|Thermalon Dry Eye Compress|Application of Thermalon Dry Eye Compress at Day 0, Day 7 and daily use as per label instructions.
15954865|NCT03226756|Drug|Nivolumab Injection|Nivolumab 3 mg/kg, every 2 weeks
15954866|NCT03226743|Other|collaborative and stepped care model|"Including elements:
~collaborative and stepped care of patients with mental disorders
~treatment in a multiprofessional network consisting of primary care physicians, psychologists, psychiatrists and inpatient facilities
~initial training of participating health care providers
~formalized and standardized screening procedure for early recognition of depressive, anxiety, somatoform and alcohol abuse disorders
~formalized ICD-diagnostics
~guideline-oriented treatment recommendations
~bibliotherapy or internet-based self-help for patient with mild to moderate disorders
~online referral platform
~case management for patients with severe disorders
~systematic and regular monitoring
~regular quality circles for participating health care providers"
15954867|NCT03226730|Behavioral|Household Visits|Household visits will be conducted to build trust in the health system, educate regarding different forms of modern contraception, (how administered, how they work, availability), dispel related myths (i.e., those regarding infertility), promote the health advantages of birth spacing, and create related dialogue among adolescent wives and other household members present during these visits. The relais will provide and resupply oral contraceptive pills and condoms to interested participants and will accompany the married adolescent to the nearest health facility for other forms of contraception, if requested to do so. To complement the household visits to married female adolescents, male relais will conduct home visits to discuss healthy timing and spacing of pregnancy with husbands of adolescent females, provide education on different forms of contraception, and discuss concerns husbands may have regarding use of contraception.
15954868|NCT03226730|Behavioral|Small Groups|In the wife-only groups, adolescent wives will be convened by trained adult female community members to learn and discuss a broad range of gender and health-related topics, with a focus on modern contraception, and cultivate self-efficacy, social support and life skills. The small groups will be led by trained female small group mentors who are trained peers and will follow a designated curriculum consisting of different topics each week developed by Pathfinder International and derived from Population Council/UNFPA's Safe Spaces curriculum. The husband groups will follow a curriculum adapted from Promundo's Program P6 and supplemented by the tools and activities developed by Pathfinder International. These groups of husbands will focus on fostering reflection and dialogue to contribute to more equitable gender norms, support for contraception use for HTSP, positive health seeking behavior for them and their families, and increased couples communication and joint SRH decision-making.
15954869|NCT03226717|Drug|Antiviral agents|combination therapy consists of Sofosbuvir,daclatasvir and ribavirin
15954870|NCT03226691|Drug|Plerixafor|Single-dose subcutaneous administration of plerixafor (Mozobil®) at 240 μg/kg
15954871|NCT03226678|Drug|APL-2|Complement (C3) Inhibitor
15954872|NCT03226665|Diagnostic Test|ultrasound|"definition of prevalence of US detected obstruction in patients referred to an emergency facilities with symptoms potentially suggestive for such diagnosis.
~Moreover, which clue, if any, could reinforce the need of US intestinal study, such as anaemia, CRP, NLR, hypotension.
~This information is not yet available elsewhere. Moreover, in this context, sensitivity and specificity of ultrasound vs. confirm by CT and other procedures will make more sense and will be consequently assessed."
15954873|NCT03226626|Drug|Tumescent Anesthesia and antibiotic delivery (TAAD) plus IVAD|Concomitant tumescent anesthesia antibiotic delivery (TAAD) & Intravenous antibiotic delivery (IVAD).
15954874|NCT03226626|Device|SubQKath|The device intervention consists of using the SubQKath device to provide subcutaneous delivery of antibiotics.
15954875|NCT03226613|Procedure|Transcervical Oropharyngeal Ultrasound|One time approximately 15 minute ultrasound will be conducted at the time of clinic visit, focusing on the base of tongue and palatine tonsil via transcervical approach.
15954876|NCT03226613|Procedure|Oral Rinse Collection|Patients will provide a one time oral rinse specimen using a non-alcoholic mouthwash at the time of clinic visit. The participant will be instructed to swish vigorously for 5 seconds and then gargle 5 seconds. The participant will be asked to repeated the swish and gargle (5 seconds each) three times for a total of 30 seconds and then expel the wash in a 10mL conical tube.
15954877|NCT03226613|Procedure|Blood Draw|A certified phlebotomist will perform a one time blood draw of 10mL at the time of clinic visit from each participant for purposes of HPV serologic testing.
15954878|NCT03226600|Device|OrACELL|OrACELL is human dermis that undergoes the MATRACELL process. MATRACELL is a patented and validated process that renders allograft tissue acellular, without compromising the biomechanical or desired biochemical properties of an allograft bio-implant for its intended surgical application.
15954879|NCT03226600|Device|Connective Tissue Graft|A measured layer of dermis is surgically removed from the palate for use as a graft to cover gingival recession
15954880|NCT03226587|Procedure|Blue light|Subjects will be exposed to blue light (453 nm wavelength) for 30 minutes
15954881|NCT03226587|Procedure|control exposure|Subjects will get control exposure to 30 minutes of whole body, which causes only comparable warming of skin as with blue light exposure.
15954882|NCT03226574|Drug|Resiniferatoxin|single dose (0.4, 1, 2, 4, 8,15, 25 or 35 mcg), epidural injection
15954883|NCT03226561|Procedure|Phaco / Panoptix|Phacoemulsification with bilateral diffractive trifocal lens implantation
15954884|NCT03226548|Other|Paycheck Plus|A four-fold increase in the Earned Income Tax Credit
15954885|NCT03226535|Device|Ultrasound-CT Fusion|The Clear Guide SCENERGY is an Ultrasound-CT fusion device which supplements existing ultrasound and CT capabilities. The participants randomly selected (out of 20 patients) for use of the Clear Guide SCENERGY (test group) will receive ultrasound-CT fusion guidance from the MDs performing the procedure.
15954886|NCT03226522|Drug|AXS-05|AXS-05
15954887|NCT03226522|Drug|Bupropion|Bupropion
15954888|NCT03226522|Drug|Placebo|Placebo
15954889|NCT03226496|Behavioral|motivational interviewing|
15954890|NCT03226483|Radiation|Intraoperative Radiotherapy|Intraoperative Radiotherapy is performed with a mobile radiation device emitting soft energy x-rays in a spherical way. Different size applicators are available to cover the resection cavity after the tightest fit rule.
15954891|NCT03226470|Biological|T27|T27 suppository contain 500 µg of T27 and suppocire.
15954892|NCT03226470|Biological|T512|T512 suppository contain 500 µg of T512 and suppocire.
15954893|NCT03226457|Drug|Empagliflozin 25mg|Empagliflozin (SGLT2 inhibitor) 25 mg once daily for 6 weeks
15954894|NCT03226457|Drug|Placebo oral capsule|Capsules containing microcrystalline cellulose Ph Eur over encapsulated in a hard gelatine capsule shell to match the active comparator once daily for 6 weeks
15954895|NCT03226457|Drug|Frusemide|Renal Physiology Test (RPT) days will be performed at week 1 and week 6 on each arm of this crossover trial. On these RPT days participants will undergo oral water loading (15mls/kg) and frequent urination at 30 minute intervals to gain a steady state diuresis. At a set time point, an intravenous bolus of furosemide at a dose of half the participant's usual loop diuretic dose will be administered.
15954896|NCT03226444|Drug|0.005% Lacripep|One drop (approximately 50 microliters) of 0.005% ophthalmic solution will be administered three times a day (TID) to both eyes for four weeks.
15954897|NCT03226444|Drug|0.01% Lacripep|One drop (approximately 50 microliters) of 0.01% ophthalmic solution will be administered three times a day (TID) to both eyes for four weeks.
15954898|NCT03226444|Drug|Placebo|One drop (approximately 50 microliters) of placebo solution will be administered three times a day (TID) to both eyes for four weeks.
15954899|NCT03226431|Drug|Ascorbic Acid|ARINA-1 (inhaled ascorbic acid 88 mg/ml) will be nebulized twice daily for 3 months using a PARI eFlow nebulizer
15954900|NCT03226418|Drug|Cytarabine|Given IV
15954901|NCT03226418|Drug|Decitabine|Given IV
15954902|NCT03226418|Drug|Idarubicin|Given IV
15954903|NCT03226418|Other|Laboratory Biomarker Analysis|Correlative studies
15954904|NCT03226418|Drug|Liposome-encapsulated Daunorubicin-Cytarabine|Given IV
15954905|NCT03226418|Other|Quality-of-Life Assessment|Ancillary studies
15954906|NCT03226418|Other|Questionnaire Administration|Ancillary studies
15954907|NCT03226418|Drug|Azacitidine|Given by infusion
15954908|NCT03226418|Drug|Venetoclax|oral tablet
15954909|NCT03226418|Drug|glasdegib|oral tablet
15954910|NCT03226405|Other|Patient Navigation Program|PN program improve access, timeliness and adherence with cancer treatment
15954911|NCT03226405|Other|Usual Care|the standard of care provided by the institution
15954912|NCT03226392|Drug|QAW039|QAW039 once daily
15954913|NCT03226392|Drug|Placebo|Placebo once daily
15954984|NCT03225885|Other|Multimedia Information|Is a multi-media mobile application that addresses information about prematurity, resuscitation, and NICU hospitalization.
15954985|NCT03225885|Other|Printed Handout|Printed Handout is a gestational age specific handout that addresses resuscitation and prematurity information.
15954914|NCT03226379|Other|DREAMM|"4 DREAMM interventions to reduce HIV-related meningoencephalitis mortality once access to essential diagnostic tests and medicines:
~Health system strengthening
~Delivery of a co-designed education program tailored to frontline healthcare workers
~Implementation of an algorithm for HIV-related meningoencephalitis
~Infectious diseases/AHD mentorship and laboratory capacity building"
15954915|NCT03226366|Other|Immediate evaluation by multidisciplinary team|Simultaneous initial evaluation by the ED physician, nurse, and patient care associate
15954916|NCT03226353|Device|somofilcon A|contact lens
15954917|NCT03226353|Device|omafilcon A|contact lens
15954918|NCT03226340|Drug|S-amlodipine 2.5mg + Chlorthalidone 25mg|patients will receive S-amlodipine 2.5mg + Chlorthalidone 25mg p.o. once a day for 12 weeks.
15954919|NCT03226340|Drug|S-amlodipine 2.5mg + Telmisartan 40mg|patients will receive S-amlodipine 2.5mg + Telmisartan 40mg p.o. once a day for 12 weeks.
15954920|NCT03226327|Dietary Supplement|formula salt with very low sodium (Brand name: Manlikang)|hypertension patients will use the formula salt with very low (<20%) sodium （Manlikang) for six weeks, and will be followed up at 1, 2, 4 and 6 weeks to assess the 24-hour urine sodium.
15954921|NCT03226314|Procedure|stool sample|study will be proposed to all patients entering emergency ward or intensive care unit in Reunion Island university hospital. Upon consent, a stool sample will be taken (either directly on emitted stools or by rectal sampling) and analysed for enterobacteriaceae.
15954922|NCT03226301|Drug|Ibrutinib + Venetoclax 15 cycles|"Cycle 1 + 2: 420 mg ibrutinib, day 1-28 | Cycle 3: 420 mg ibrutinib, day 1-28 | 20 mg venetoclax, day 1-7 | 50 mg venetoclax, day 8-14 | 100 mg venetoclax, day 15-21 | 200 mg venetoclax, day 22-28 | Cycle 4-15: 420 mg ibrutinib, day 1-28 + 400mg venetoclax, day 1-28"
15954923|NCT03226301|Drug|Ibrutinib until progression/relapse|420mg ibrutinib daily until progression/relapse
15954924|NCT03226301|Drug|Possible reinitiation treatment: Ibrutinib + Venetoclax 12 cycles|"Cycle 1: 420 mg ibrutinib | 20 mg venetoclax, day 1-7 | 50 mg venetoclax, day 8-14 | 100 mg venetoclax, day 15-21 | 200 mg venetoclax, day 22-28 | cycles 2-12: 420 mg ibrutinib, day 1-28 + 400 mg venetoclax, day 1-28"
15954925|NCT03226275|Drug|Bisoprolol-Amlodipine FDC|Participants received a single oral dose of 5 milligram(mg)/5 mg bisoprolol-amlodipine FDC tablet (Concor AM®) either on Day 1 or Day 15 under fasting or fed conditions.
15954926|NCT03226275|Drug|Bisoprolol|Participants received 5 mg bisoprolol tablet as a single oral dose either on Day 1 or Day 15 under fasting or fed conditions.
15954927|NCT03226275|Drug|Amlodipine|Participants received 5 mg amlodipine tablet as a single oral dose either on Day 1 or Day 15 under fasting or fed conditions.
15954928|NCT03226262|Device|FFRangio|"FFRangio is a non-invasive image-based software device that provides physicians with a quantitative analysis of functional significance of the coronary lesion, similar to invasive FFR (Fractional Flow Reserve), and a qualitative three-dimensional model of the demonstrated coronary arteries, during routine PCI procedure. The CathWorks FFRangio software device is able to perform all required processing and calculations, based only on angiography images and hemodynamics information that are acquired during the coronary catheterization procedure.
~The CathWorks FFRangioTM technology does not require any additional use of invasive devices, or any additional vasodilation treatment, as required by other known FFR techniques."
15954929|NCT03226249|Procedure|Computed Tomography|Undergo FDG-PET/CT
15954930|NCT03226249|Drug|Dacarbazine|Given IV
15954931|NCT03226249|Drug|Doxorubicin Hydrochloride|Given IV
15954932|NCT03226249|Radiation|Fludeoxyglucose F-18|Undergo FDG-PET/CT
15954933|NCT03226249|Other|Laboratory Biomarker Analysis|Correlative studies
15954934|NCT03226249|Biological|Pembrolizumab|Given IV
15954935|NCT03226249|Procedure|Positron Emission Tomography|Undergo FDG-PET/CT
15954936|NCT03226249|Drug|Vinblastine Sulfate|Given IV
15954937|NCT03226236|Radiation|boost radiotherapy (XRT)|Three daily doses boost radiotherapy (XRT) at 6-12 Gy to at least 1, and up to a maximum of 5, metastatic fields, will be administrated on days -4 -3 -2 or -3 -2 -1 before the first and the third cycle of vaccine+IL-2
15954938|NCT03226236|Biological|Autologous DC vaccine|The first dose (7 to 14 x 10_6 total dendritic cells) will be performed with freshly prepared vaccine, 9 days after leukapheresis; on day +1 starting from cycle 2 (3 weeks after the first cycle, on completion of QA assessments on the cryopreserved products), 5 additional doses will be administered every 3 weeks until maximum six vaccines.
15954939|NCT03226236|Drug|High-Dose IL-2|high dose IL-2: 18 MIU/m2/day in 500cc administered by continuous IV infusion for 72 hours starting day +2.
15954940|NCT03226223|Drug|Intranasal Methamphetamine|Intranasal Methamphetamine HCL administered at a dose of 30mg per 70 kg of the participants' body weight)
15954941|NCT03226210|Drug|aspart insulin or lipro insulin|After completing OGTTS, enrolled subjects (new diagnosed T2DM) were randomly assigned into two groups: NovoRapid group (group Asp, Novo Nordisk, Bagsvaerd, Denmark) and Prandilin group (group Lis, Gan & Lee pharmaceuticals, Beijing, China) in CSII, combined with metformin (Bristol-Myers Squibb, USA) therapy. During insulin intensive therapy, every patient general use 1.5g metformin per day. If the patient is unable to tolerate the side effects of metformin, such as diarrhea, nausea, vomiting, allergies, etc., the daily dose of metformin is reduced to 1.0g. If the patients are still unable to tolerate the daily 1.0g of metformin, exit from this study.
15954942|NCT03226197|Dietary Supplement|Ketone ester drink|Ketone ester drink
15954943|NCT03226171|Drug|Dose-adjusted SK-1403|SK-1403 is to be administered to patients for the whole treatment periods (52 weeks), with individual dose adjustment
15954944|NCT03226145|Procedure|MRI Motility|MRI sequence to assess colonic motility
15954945|NCT03226145|Procedure|High Resolution Manometry|HRM of colon to assess motility
15954946|NCT03226145|Drug|Bisacodyl|Given as agent to monitor effect on symptoms and then to compare with motility data. Drug itself not being tested.
15954947|NCT03226145|Drug|Hyoscine butylbromide|Given as agent to monitor effect on symptoms and then to compare with motility data. Drug itself not being tested.
15954948|NCT03226132|Behavioral|Brief Behavioral Therapy for Insomnia|Brief Behavioral Therapy for Insomnia
15954949|NCT03226132|Behavioral|Repeated Contact|Repeated Contact
15954950|NCT03226119|Diagnostic Test|MP Diagnostics HTLV Blot 2.4|HTLV I/II Confirmation and Differentiation
15955141|NCT03224533|Diagnostic Test|Diabetes Outcome|based on self report definition, fasting plasma glucose, and hemoglobin A1c
15955142|NCT03224520|Behavioral|Recommender CTHC|Enhanced Messaging
15954951|NCT03226106|Behavioral|Physical Activity Behavior Intervention|Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and researcher. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
15954952|NCT03226106|Other|Attention Control|Conventional rehabilitation with supplemental 10 telerehabilitation sessions that match the frequency and duration of the experimental arm. Attention control intervention provided as 10 telerehabilitation sessions of non-physical activity related education-only sessions.
15954953|NCT03226093|Procedure|Stromal Vascular Fraction|The fat was separated via centrifuge to isolate the SVF and the cells were delivered intraarticularly, intravenously, intrathecally, or intradiscally directly into the same patient
15954954|NCT03226080|Drug|Rocuronium|The neuromuscular blockade group will receive intravenous rocuronium
15954955|NCT03226080|Drug|Sugammadex|The neuromuscular blockade group will receive intravenous sugammadex for reversal of residual rocuronium
15954956|NCT03226080|Drug|Normal saline|Normal saline will be administered as a placebo in equal volume for the placebo group
15954957|NCT03226067|Drug|GKT137831|GKT137831 100mg capsules. To be taken as part of two dose arms which are 400mg twice daily or 400mg once daily.
15954958|NCT03226067|Drug|Placebo oral capsule|Matching capsules.
15954959|NCT03226054|Behavioral|Lifestyle Modifications|Lifestyle Modifications to wean off of a Proton Pump Inhibitor, i.e. avoiding dietary triggers, waiting 3 hours to lie flat, and elevating the head of the bed
15954960|NCT03226041|Device|transcutaneous monitor (TCM-4 monitor)|TCM-4 monitor, which had changed new electrode membrane and was calibrated by the same person(who had been trained systematically) before each placement. The electrode should be heated to 44℃, then fixed it to the anterior part of chest in the location of lateral position after remove grease by alcohol. The positon of electrode must be changed every 2 hours in order to avoid thermal injury, and should be calibrated again.
15954961|NCT03226028|Procedure|Music listening|Patient is given an ipod with earphone and with saved playlists of different music genres. Music listening session will be given for 30 minutes before and after surgery. Questionnaires will be asked to fill in. All the earphones will be disinfected following the hospital's infection control guideline.
15954962|NCT03226002|Device|Airtraq NT|channeled video laryngoscope for nasotracheal intubation
15954963|NCT03225989|Drug|LOAd703|Oncolytic adenovirus serotype 5/35 encoding TMZ-CD40L and 4-1BBL
15954964|NCT03225976|Device|Light-Emitting Diode Device|"The therapy will be applied on the second, third and fourth day of collection using a 25x40 cm2 LED blanket, with an equidistant distribution, with total energy per area of 180 J bilaterally on the quadriceps femoris muscle.
~All LEDs will be calibrated prior to the start of applications in the Laboratory of Photobiophysics of the Faculty of Sciences and Letters of Ribeirão Preto, University of São Paulo, in which the wavelengths will be checked, the angle of radiation, power and power density."
15954965|NCT03225976|Device|Sham Light-Emitting Diode Device|The Sham Light-Emitting Diode Device will be applied on the second, third and fourth day of collection using a 25x40 cm2 LED blanket, with an equidistant distribution, with total energy per area of 0 J bilaterally on the quadriceps femoris muscle. At the time of application the device will not be activated
15954966|NCT03225963|Radiation|Chemoradiation with temozolomide|
15954967|NCT03225950|Other|In vitro stimulation of blood with periodontitis-associated- and control bacteria|Peripheral mononuclear blood cells are stimulated with periodontitis-associated- and control bacteria to measure the amount of positive cytokine-producing cells.
15954968|NCT03225950|Diagnostic Test|Anti-CCP- and anti-P.g.-antibodies titers|Anitbody titers will be measured in saliva and serum samples.
15954969|NCT03225950|Genetic|Analysis of selected single nucleotide polymorphisms (SNPs)|DNA obtained from saliva samples will be used to determine the genotype of the participants for selected SNPs.
15954970|NCT03225950|Diagnostic Test|periodontitis-associated bacteria presence|Determination of the presence of periodontitis-associated bacteria e.i. Porphyromonas gingivalis in saliva and blood samples.
15954971|NCT03225937|Drug|Trastuzumab, Lapatinib|Patients enrolled in Cohort A will receive lapatinib 1000 mg daily per os + trastuzumab 4 mg/kg iv load, followed by 2 mg/kg iv weekly. Patients will receive study medication until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever come first.
15954972|NCT03225937|Drug|Pertuzumab, trastuzumab-emtansine|"Patients enrolled in Cohort B will receive pertuzumab 840 mg iv load, followed by 420 mg iv Q3weeks + trastuzumab-emtansine 3.6 mg/kg iv on day 1 of each subsequent 3 week cycle.
~Patients will receive study medication until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever come first."
15954973|NCT03225924|Drug|Entospletinib|200mg or 400mg twice a day for 7 days every 21 cycles - total of 8 cycles
15954974|NCT03225924|Drug|Rituximab|cycles of 21 days - 375mg/m²
15954975|NCT03225924|Drug|Cyclophosphamide|cycles of 21 days - 750 mg/m²
15954976|NCT03225924|Drug|Doxorubicin|cycles of 21 days - 50mg/m²
15954977|NCT03225924|Drug|Vincristine|cycles of 21 days - 1.4mg/m²
15954978|NCT03225924|Drug|Prednisone|cycles of 21 days - 40mg/m²
15954979|NCT03225911|Device|Lateral wedge insole (insole)|The lateral wedge insole is an orthotic device that is placed inside the shoe. It has different thicknesses, with the lateral side being thicker than the medial side. This difference in thickness leads to the lateral side being higher than the medial side, with a different angulation.
15954980|NCT03225911|Device|simple knee sleeve (sleeve)|The simple knee sleeve is support which is worn around the knee with no hinge or provide external valgus moment.
15954981|NCT03225911|Device|simple knee sleeve + lateral wedge insole|The lateral wedge insole is an orthotic device that is placed inside the shoe. It has different thicknesses, with the lateral side being thicker than the medial side. This difference in thickness leads to the lateral side being higher than the medial side, with a different angulation. The simple knee sleeve is support which is worn around the knee with no hinge or provide external valgus moment.
15954982|NCT03225898|Other|Resistance Exercise with Blood Flow Restriction|A cuff will be used to restrict blood flow to the extremities.
15954983|NCT03225898|Other|High-intensity Resistance Exercise|Participants will follow a conventional resistance exercise regime.
15955143|NCT03224520|Behavioral|Standard CTHC|Standard Messaging
15954986|NCT03225859|Behavioral|Self-Management Program|This therapist-assisted self-management program will increase Veterans' self-efficacy for managing their PTSD, enable the maintenance or building upon gains made in trauma-focused therapy, and encourage engagement in meaningful activities. Patients will have four contacts with their providers over the ten weeks following trauma-focused therapy completion. The intervention will help patients: 1)self-monitor symptoms, 2) continue to practice skills learned in trauma-focused therapy, 3) acquire and apply additional coping skills, 4) engage in meaningful activities, and 5) set goals
15954987|NCT03225846|Drug|WVE-120102|WVE-120102 is a stereopure antisense oligonucleotide (ASO)
15954988|NCT03225846|Drug|Placebo|0.9% Sodium Chloride
15954989|NCT03225833|Drug|WVE-120101|WVE-120101 is a stereopure antisense oligonucleotide (ASO)
15954990|NCT03225833|Drug|Placebo|0.9% Sodium Chloride
15954991|NCT03225794|Diagnostic Test|Simian foamy virus Infection|Plasma samples are tested for the presence of antibodies directed against foamy viruses by western blotting (WB). The BHK-21 cell line infected with a chimpanzee foamy virus is used as a source of viral antigen. Samples are considered to be positive if there is net reactivity against the GAG doublet (70 to 74 kD). High molecular weight DNA will be extracted, from either buffy coats, cell cultures, or both, for molecular biology studies. The presence and quality of the DNA will be verified by amplification of a fragment of the beta-globin gene. Two regions of foamy virus genomic DNA will be amplified by nested PCR, using generic amplimers, giving rise to fragments of the integrase gene (425 bp) and LTR (109 bp).
15954992|NCT03225781|Device|Electrochemotherapy with Bleomycin|Application of Reversible Electroporation (Electrochemotherapy) with Bleomycin
15954993|NCT03225768|Behavioral|Guided Training|Guided training is an intervention strategy designed to help individuals identify barriers in their daily life and guide them to generate their own strategies to address these barriers. This intervention strategy is different from traditional direct skill training, in which rehabilitation practitioners are responsible for identifying their patients' challenges to perform activities and teaching them task-specific problem-solving strategies. Guided training has been applied in a variety of clinical populations, including individuals with stroke and TBI, and has demonstrated significant effect on improving independence with daily activities among persons with acute stroke-related cognitive impairments enrolled in inpatient rehabilitation.
15954994|NCT03225755|Drug|Growth hormone|Patients will receive growth hormone replacement therapy as per standard clinical care during this study.
15954995|NCT03225742|Diagnostic Test|to measure the residual volume after catheterization|after first micturition to measure the residual volume in bladder
15954996|NCT03225729|Device|CRYOBEAUTY MAINS ET DECOLLETE|The intervention lasts up to 6.5 s. The device will be applied on spots <6 mm which are previously selected by the investigator team.
15954997|NCT03225729|Device|Liquid nitrogen|The intervention lasts up to 3 s. The liquid is stored in well-isolated recipients. Each patient has his recipient to avoid contamination. The investigator applies on spots <6 mm a small amount of nitrogen liquid.
15954998|NCT03225716|Drug|Ulocuplumab|Ulocuplumab is a type of protein called an antibody that attacks CXCR4
15954999|NCT03225716|Drug|Ibrutinib|Ibrutinib small-molecule inhibitor of Bruton's tyrosine kinase (BTK) with potential antineoplastic activity
15955000|NCT03225703|Behavioral|Hopping|A unilateral, hopping based exercise programme lasting six months.
15955001|NCT03225690|Drug|Morphine|Prevention of remifentanil induced hyperalgesia
15955002|NCT03225690|Drug|Serum physiologic|For placebo, serum physiologic will use
15955003|NCT03225677|Procedure|blood draw and muscle biopsy|One venous catheter will be used for bolus injection of multiple labeled AA at the beginning .The second venous catheter will inserted in the other arm for 5 ml of arterialized venous blood draw.Following the infusions, a single muscle biopsy will be performed from the vastus lateralis of the thigh using the Bergstromm needle.
15955004|NCT03225664|Biological|Pembrolizumab|Given IV
15955005|NCT03225664|Other|Pharmacokinetic Study|Correlative studies
15955006|NCT03225664|Drug|Trametinib|Given PO
15955007|NCT03225651|Biological|Stem cell transplantation|Transplantation of Autologous Bone Marrow Mononuclear cells
15955008|NCT03225651|Behavioral|Psychological therapy and Rehabilitation|Psychological Therapy and Rehabilitation for autism children around 3 months
15955009|NCT03225638|Combination Product|Intramuscular ZENEO® injection of nominal strength|Sodium Chloride (0.9%)
15955010|NCT03225638|Combination Product|Intramuscular ZENEO® injection of low strength (upper limit)|Sodium Chloride (0.9%)
15955011|NCT03225638|Combination Product|Intramuscular ZENEO® injection of low strength (lower limit)|Sodium Chloride (0.9%)
15955012|NCT03225625|Procedure|Paraspinal|BMSC provided by paraspinal injection, intravenous and intranasal
15955013|NCT03225625|Procedure|Paraspinal EX|BMSC provided by paraspinal injections, intravenous and intranasal followed by exoskeleton or equivalent stimulation
15955014|NCT03225625|Procedure|Paraspinal VR|BMSC provided by paraspinal injections, intravenous and intranasal followed by virtual reality or equivalent visualization
15955015|NCT03225612|Device|Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)|Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) is delivered by a percutaneous transcatheter procedure. The Trialign PTVAS procedure utilizes catheters and wires to deliver up to two sets of pledgeted sutures across the tricuspid annulus near the septal/posterior and the posterior/anterior commissures. Each set of implants is pulled together to plicate the posterior tricuspid annulus.
15955016|NCT03225599|Other|Cranial Osteopathic Manipulative Medicine|"The hands will be placed on the head using the vault hold (bilateral thumbs are off the head, index fingers on the temporal bones, middle fingers on the sphenoid bones, ring fingers on the mastoid and the 5th fingers on the occipital bone). Diagnosis and treatment of restrictions palpated on the scalp will be made using this hand position"
15955017|NCT03225560|Other|Bowel Preparation|Bowel Preparation is completed prior to colonoscopy to ensure adequate visualization of the bowel lumen. This requires diet modifications and taking of medications at specified time intervals.
15955018|NCT03225547|Drug|Pembrolizumab|Pembrolizumab 200mg will be administered to all patients on day 1 of every 21 day cycle.
15955019|NCT03225547|Drug|Mifepristone|Mifepristone 300mg will be administered to all patients daily starting the week prior to pembrolizumab.
15955144|NCT03224520|Other|Peer Recruitment|Tools to facilitate smokers' recruiting their peers
15955020|NCT03225521|Behavioral|HeartSteps: A just-in-time adaptive intervention for increasing physical activity amongst sedentary adults.|HeartSteps is an Android-based mHealth intervention that contains two main intervention components: contextually-tailored suggestions for activity and planning of the next day's activity. Activity suggestions provide individuals with actionable suggestions for how they can be active in their current context. Delivered suggestions are tailored based on time of day, user's location, day of the week (weekend/weekday), and weather. HeartSteps can deliver a user activity suggestions up to five times a day. Evening planning asks users to create or choose a plan of how they will be active on the following day. Planning can be delivered once a day, in the evening.
15955021|NCT03225508|Diagnostic Test|Linear Ultrasound to Measure Diaphragmatic Movement|A linear 10-12 MHz ultrasound probe will be used to determine diaphragmatic excursion, by examining the zone of apposition. Diaphragmatic excursion will be measured from end inspiration to end expiration. The measurement will be repeated twice, and an average of the two will be taken. The distance between the two external skin markings, one at the end of full expiration and one at the end of full inspiration will indicate the excursion of the diaphragm.
15955022|NCT03225508|Diagnostic Test|Curvilinear Ultrasound to Measure Diaphragmatic Movement|A curvilinear 2-5 MHz ultrasound probe will be used to determine diaphragmatic excursion, by examining the dome of the diaphragm. M-mode will be used to image the motion of the diaphragm from end inspiration to end expiration. The measurement will be repeated twice, and an average of the two will be taken.
15955023|NCT03225508|Diagnostic Test|Pulmonary function tests|Bedside pulmonary function tests to measure forced vital capacity (FVC). The FVC measures the maximal volume of gas that can be expired as forcefully and rapidly as possible after a maximal inspiration to total lung capacity. This measurement will help determine if the patient has any obstructive or restrictive diseases of the airways. Three measurements will be taken.
15955024|NCT03225495|Procedure|Standard implant|Arm - Standard Implant: implant placement in combination with guided bone regeneration;
15955025|NCT03225495|Procedure|Ultra-narrow implant|Arm - Ultra-narrow implant: implant placement without guided bone regeneration
15955026|NCT03225482|Behavioral|Motivationally Enhanced Compensatory Cognitive Training|ME-CCT is a manualized group-based behavioral intervention (8 weeks, 2 hours per week, 20 hours total) designed to improve cognitive and everyday functioning in patients with MCI.
15955027|NCT03225482|Behavioral|Goal-focused Supportive Contact|SC is a group therapy intervention that provides the same frequency and amount of therapist and other group member contact as ME-CCT, but does not provide training in cognitive strategies, lifestyle strategies, or motivational enhancement. The SC intervention focuses on setting and achieving short or long-term goals.
15955028|NCT03225469|Behavioral|reinforced family member education|Based on regular instructions for patent education, at least one family member who lives with the patient together will be given special instruction.
15955029|NCT03225456|Drug|Syntocinon|Intra-nasal oxytocin
15955030|NCT03225456|Drug|Placebos|Intra-nasal placebo
15955031|NCT03225430|Behavioral|Cognitive behavioural treatment for tics|Mainly based on the habit reversal treatment (HRT) and in addition to HRT components, they learn awareness training, relaxation, competing response, contingency management, and generalization training.
15955032|NCT03225430|Behavioral|Cognitive psychophysiological|Focus on the processes influencing thoughts and behaviors underlying tics.
15955033|NCT03225417|Drug|Ixazomib|Ixazomib capsules. Phase I: Starting dose of Ixazomib: 3.0 or 4.0 mg by day +1, +8 and +15. Phase II: Starting Dose of Ixazomib: Maximum tolerated dose from Phase I.
15955034|NCT03225417|Drug|Tacrolimus|Tacrolimus at dose of 0.02 mg/kg/day and then 0.06 mg/kg/day.
15955035|NCT03225417|Drug|Sirolimus|Sirolimus oral solution. Standing 6 mg orally on day -5 and continued 4mg per day. This drugs should be slowly tapered starting 3 months posttransplant in order to stop them at 9 to 12 months posttransplant according to physician criteria.
15955036|NCT03225417|Drug|Any prophylaxis for GVHD|Except antithymocyte globulin, cyclophosphamide or any T depletion protocol in vitro or in vivo.
15955037|NCT03225404|Other|Epte group|Therapeutic Percutaneous Electrolysis once week for four weeks associated with eccentric exercises devices at home.
15955038|NCT03225404|Other|Dry needling group|The intervention for this group consisted of dry needling in trigger points associated with eccentric exercises devices at home.
15955039|NCT03225391|Behavioral|nap from 0:00 to 3:00 hours|A nap from 0:00 to 3:00 hours during a night shift.
15955040|NCT03225391|Behavioral|nap from 3:00 to 6:00 hours|A nap from 3:00 to 6:00 hours during a night shift.
15955043|NCT03225365|Biological|Blood and biopsy sampling|"Blood samples (52mL) will be taken at week 1, week 3, week 7, week 13, week 53 or at the progression.
~Skin biopsies will be taken at week 1, week 7, week 53 or at the progression."
15955044|NCT03225352|Drug|500 mg acetylsalicylic acid (Aspirin, BAYE4465)|Single intake of 1 tablet, 500mg
15955045|NCT03225352|Drug|1000 mg acetylsalicylic acid (Aspirin, BAYE4465)|Single intake of 1 tablet, 1000mg
15955046|NCT03225352|Drug|400 mg ibuprofen(Nurofen)|Single intake of 1 tablet, 400mg
15955047|NCT03225352|Drug|400 mg ibuprofen (Dolormin Extra)|Single intake of 1 tablet, 400mg
15955048|NCT03225339|Dietary Supplement|Low Energy Diet|Low Energy Diet
15955049|NCT03225326|Drug|Computer controlled 4% articaine delivery by Anaeject|Single dose of 0.6ml 4% articaine with epinephrine (1:100.000) delivered by computer controlled local anesthetic delivery system (Anaeject)
15955050|NCT03225326|Drug|Conventional 4% articaine delivery by carpule syringe|Single dose of 0.6ml 4% articaine with epinephrine (1:100.000) delivered by conventional syringe (carpule syringe).
15955051|NCT03225313|Drug|Bupivacaine Hydrochloride 0.5% Injection Solution_#4|ultra sound guided injection into the rectus sheath
15955052|NCT03225313|Drug|Normal Saline Flush, 0.9% Injectable Solution_#5|injected into rectus sheath using ultrasound & locally surrounding the hernia
15955053|NCT03225313|Drug|Bupivacaine Hydrochloride 0.5% Injection Solution_#4|locally surrounding the hernia
15955145|NCT03224520|Other|Standard Online Recruitment|Search Engine and Social Media Advertisements
15955379|NCT03222622|Drug|Icotinib hydrochloride cream|Apply topically twice daily for 12 consecutive weeks
15955054|NCT03225300|Radiation|Simultaneous integrated boost|Simultaneous integrated boost (SIB), a field-in-field escalation technique, has been introduced to deliver higher radiation dose to the certain part of target with the same fractionation scheme.
15955055|NCT03225287|Drug|Zilucoplan (RA101495)|Subjects will continue to receive the final maintenance dose they were receiving in the qualifying study.
15955056|NCT03225274|Other|Breathing Exercises as Therapeutic Play|"On day 1, pre- intervention assessment of respiratory status was done before administration of breathing exercises as therapeutic play and after 5 minutes of administration of Nebulization therapy, breathing exercises was administered among children for 15 minutes once in a day and then after 5 minutes 1st post-intervention assessment was done on same day.
~On 2nd day again after 5 minutes of administration of Nebulization therapy, breathing exercises was administered among children for 15 minutes once in a day and after 5 minutes again post-intervention assessment was done on same day.
~On 3rd day again after 5 minutes of administration of Nebulization therapy, breathing exercises was administered among children for 15 minutes once in a day and after 5 minutes again post-intervention assessment was done on same day."
15955057|NCT03225261|Dietary Supplement|Citrus extract|Citrus extract
15955058|NCT03225261|Dietary Supplement|Placebo|Maltodextrin
15955059|NCT03225248|Drug|UI05MSP015CT|UI05MSP015CT and Placebo of Gasmotin
15955060|NCT03225248|Drug|Gasmotin|Placebo of UI05MSP015CT and Gasmotin
15955061|NCT03225235|Radiation|SBRT|hypofractionated stereotactic radiotherapy (SBRT) using CyberKnife for Patients With Low and Intermediate Risk of Progression Prostate Cancer
15955062|NCT03225222|Diagnostic Test|biopsy|prostate biopsy
15955063|NCT03225209|Other|OPTIFAST|OPTIFAST meal replacement includes shakes, bars and soups. These meal replacements will completely replace the subject's diet for the first 12 weeks of the study (baseline-week 12) followed by a gradual transition back to prepared meals over 6 weeks (week 13-18). Attempt will be made to reduce or eliminate Lantus and Metformin as long as glycemic control is maintained.
15955064|NCT03225170|Behavioral|Self Affirmation|Participants will be asked to rank artistic skills, athletics, business/money, creativity, independence, music, politics, relationships with friends and family, religious values, sense of humor, spontaneity from most important to least important. They will then be asked to write about the item that is most important to them and why it may be important to them. The control group will rank the same list and be asked to will write about the 9th ranked item and why it might be important to someone else. The treatment and control condition are consistent with interventions used in other SA intervention studies.
15955065|NCT03225105|Drug|M3541|Subjects will receive M3541 orally in combination with fractionated palliative RT for two consecutive calendar weeks (that is, Monday through Sunday, with Saturday and Sunday as M3541 / RT holidays).
15955066|NCT03225105|Radiation|Palliative Radiotherapy (RT)|Subjects will receive RT dose of 30 Gray (Gy) given in 10 fractions (3 Gy given per fraction day) administered over two consecutive calendar weeks (that is, Monday through Sunday, with Saturday and Sunday as M3541 / RT holidays).
15955067|NCT03225092|Biological|Ultrasound-guided platelet rich plasma injection|Each participant will receive a single injection into the pes anserine bursa (using the Arthrex Angel system with a setting of 180cc of peripheral blood and 1% hematocrit concentration) under sterile technique
15955068|NCT03225066|Device|Poly-L-lactic acid - Sculptra|Participants using Sculptra - Poly-L-lactic acid 3 sessions in the first side and 3 sessions on the second side
15955069|NCT03225053|Device|MEP® technique|G1 (n = 15), referred to as LMF, will be submitted to the myofascial release technique consisting of: classic massage (superficial sliding, deep sliding, pumping-kneading, pulse and four-finger smear and sliding) Minutes. G2 (n = 15) will be applied to the MEP® technique, in which the needles will be introduced in three occasions during each session, in different points of the musculature of the most painful region, for a total of 3 minutes. The G3 (n = 15) will execute the two techniques above, being applied the first version Myofascial and later to the MEP®. G4 (n = 15) will be the control group, not performing any of the interventions. The reevaluations will occur immediately and after 48 hours of the intervention.
15955070|NCT03225040|Drug|Pegvisomant|Subjects receiving pegvisomant as part of their clinical care for acromegaly will be studied.
15955071|NCT03225027|Behavioral|Emotional judgment task|Participants had to indicate on a computer the emotional intensity of audio recordings.
15955072|NCT03225027|Behavioral|Post-experimental questionnaire|Participants will be invited to give us the cognitive strategy used to resolve the emotional judgment task.
15955073|NCT03225027|Behavioral|Recognition task|Participants will be invited to indicate which recordings they had heard during the emotional judgment task to verify that they have paid attention to the emotional task.
15955074|NCT03225027|Behavioral|Detection task|Participants indicate every time they heard a given sound in order to verify their audition level.
15955075|NCT03225027|Other|CAPE-42|This questionnaire allows evaluating the nature of psychotic experiences.
15955076|NCT03225027|Diagnostic Test|Trait Emotional Intelligence Questionnaire|To evaluate their emotional intelligence.
15955077|NCT03225027|Diagnostic Test|Positive And Negative Syndrome Scale|Evaluating the clinical status of patients with schizophrenia.
15955078|NCT03225027|Other|Mini International Neuropsychiatric Interview|Evaluating the exclusion criteria in healthy participants.
15955079|NCT03225014|Device|Accelerated Recovery Performance Wave Therapy|ARP Wave therapy utilizes direct current compounded with a high frequency double exponential background waveform that creates an electromyostimulation with characteristics that contrast with more conventional therapeutic neuromuscular electrical stimulation, including: interferential, microcurrent, galvanic, Russian stimulation, and iontophoresis. ARPWave therapy is a class II FDA medical device that has been approved for muscle re-education, relaxation of muscle spasms, increased neovascularization, prevention of disuse atrophy, and maintaining/increasing joint range of motion. The ARPWave Rx100 uses a main electrostimulation pulse of 40 to 500 cycles per second that is coupled with a background high-frequency carrier signal at 10,000 cycles per second. The polarity direction of electron flow is reversible within the unit and this is utilized as part of the therapy.
15955146|NCT03224507|Drug|KRdD followed by auto-HCT|Dosages of each drug will vary depending on therapy type and cycle number. KRdD therapy will be followed by autologous hematopoietic cell transplantation and KRdD consolidation.
15955147|NCT03224507|Drug|KRdD only|Dosages of each drug will vary depending on therapy type and cycle number. KRdD therapy will not be followed by autologous hematopoietic cell transplantation but will proceed with KRdD consolidation.
15955080|NCT03225014|Diagnostic Test|Physical therapy|PT protocol for traumatic knee pain focuses on flexibility and development of hip core strength over a 6 week period, visiting the therapist twice per week and encouraged to maintain a home exercise program (HEP). They will all receive a handout with basic exercises to use at home to ensure that progress with their HEP is maximized (Appendix I). Basic stretches for the hamstring and quadriceps muscles will also be provided with line drawings. During this treatment period the patients will complete a daily diary of time spent on the HEP with attestation from their parents or guardians, in order to improve compliance.
15955081|NCT03225001|Device|Edwards SAPIEN XT transcatheter valve, Model 9300TFX|Edwards SAPIEN XT THV system Model 9300TFX with the associated delivery systems.
15955082|NCT03224988|Device|TMS|A multimodal approach consisting of single pulse TMS, dual-coil TMS, and EEG will be used to examine whether synchronous hemispheric interactions associated with TMS will be present in weighted phase-lag coherence (WPLI), if these measures will be enhanced by in-phase TMS and reduced by counter-phase TMS, and if WPLI will be greater for normal controls than MCI-ADs.
15955083|NCT03224975|Other|fMRI|During fMRI, patients and control group will have to thought to seven painful memories, seven emotional memories not painful, seven neutral memories. At every memory there is control test. It is to count backwards.
15955084|NCT03224962|Device|fluorescence camera|drug - diagnostic test
15955085|NCT03224949|Other|Blood draw|Patients will have a one time blood draw
15955086|NCT03224936|Device|PSI|The PSI delivered by Masimo Root (Sedline) will be measured in all patients.
15955087|NCT03224923|Drug|Ticagrelor 60mg|twice daily
15955088|NCT03224923|Drug|Clopidogrel 75mg|once daily
15955089|NCT03224923|Drug|Aspirin 81 mg|once daily
15955090|NCT03224910|Other|Cytologic techniques used for rapid on site interpretation|Diagnostic efficiency of touch imprints of needle core biopsies vs smears of fine needle aspirations during rapid on-site interpretation
15955091|NCT03224897|Device|Cathodal tDCS|"Volunteers will be submitted to 1,0 mA cathodal stimulation during experiment. The stimulation will be applied through a pair of saline-soaked surface sponge electrodes for 20 minutes, with a 10s ramp up and down. The 4,5 x 5,0 cm active electrode will be placed over the crossing point between Fz-T3 and F7-Cz and the 12 x 5 cm return electrode will be placed over Fp2 according to the 10-20 EEG system."
15955092|NCT03224897|Device|Anodal tDCS|"1,0mA anodal stimulation will be applied through a pair of saline-soaked surface sponge electrodes for 20 minutes, with a 10s ramp up and down. The 4,5 x 5,0 cm active electrode will be placed over the crossing point between Fz-T3 and F7-Cz and the 12 x 5 cm return electrode will be placed over Fp2 according to the 10-20 EEG system."
15955093|NCT03224897|Device|Sham tDCS|"1,0 mA anodal stimulation will be applied through a pair of saline-soaked surface sponge electrodes for 30 seconds, with a 10s ramp up and down. The 4,5 x 5,0 cm active electrode will be placed over the crossing point between Fz-T3 and F7-Cz and the 12 x 5 cm return electrode will be placed over Fp2 according to the 10-20 EEG system. The participant will not know when the stimulator is turned off and will continue to perform the experimental task as in the other groups."
15955094|NCT03224884|Procedure|Interscalene block|Ultrasound guided brachial plexus block injecting 20 mL of 0.5% levobupivacaine with 5 micrograms of epinephrine per mL in the interscalene groove, under the prevertebral fascia.
15955095|NCT03224884|Procedure|Supraclavicular block|"Ultrasound guided brachial plexus injecting 20 mL of 0.5% levobupivacaine with 5 micrograms of epinephrine per mL (3 mL in the corner pocket followed by 17 mL posterolateral to the brachial plexus)."
15955096|NCT03224871|Drug|Intralesional IL-2|High dose IL-2 (HD-IL-2) is a cytokine produced endogenously by activated T cells and is effective in the treatment of a variety of malignancies because it has both immune-modulating and antitumor properties. In an attempt to take advantage of the robust immune activating effects of IL-2 but avoid the toxicity of high dose systemic IL-2 we and others have investigated the use of intralesional IL-2 injections.
15955097|NCT03224871|Drug|Nivolumab|Nivolumab is a fully humanized IgG4 PD-1 blocking antibody which has shown promising efficacy as an immune checkpoint inhibitor in lung cancer. Immune checkpoint blockade will be started on week 1 day 1, concurrent with radiotherapy and continue with cycles every 2 weeks for patients on Nivolumab.
15955098|NCT03224871|Drug|Pembrolizumab|PD-1 inhibitor. Immune checkpoint blockade will be started on week 1 day 1, concurrent with radiotherapy and continue with cycles every 3 weeks for patients on Pembrolizumab.
15955099|NCT03224871|Radiation|Radiotherapy|Radiotherapy will be delivered to the treatment lesion during the first week of therapy using an 8 Gy x 3 fractions palliative regimen. Fractions may be delivered on consecutive or every other day but must be completed during week 1 and will not be repeated in future cycles.
15955100|NCT03224858|Other|SUMMIT intervention|See description in experimental arm.
15955101|NCT03224858|Other|Enhanced usual care|See description in active comparator arm.
15955102|NCT03224845|Behavioral|Cognitive behavioural skills training|The intervention will be delivered in two stages: First, the parent with an anxiety disorder will attend between six and sixteen weekly sessions of cognitive behavioural skills training focusing on their own anxiety. They will work on developing behaviours that will help them become less anxious in the long-run and on learning to evaluate danger in a realistic way. Next, the parent will take part in four to eight weekly sessions of anti-anxiety parenting skills training aiming to help them transfer the skills that they learned into parenting their children. In the parenting intervention, the parents will be guided to gradually expose their children to new situations, build communication skills and confidence, in addition to general parenting skills and principles.
15955103|NCT03224832|Procedure|Artery-first Approach|"Dissection at the origin of the superior mesenteric artery and the celiac trunk all along their right side of the vessels. -En bloc resection of the primary tumor and regional lymph nodes through complete excision of the mesopancreatic plane, utilizing the artery-first approach.
~The mesopancreatic plane consists of the pancreas head, the uncinate process of the pancreas, and the meso-pancreatoduodenum.
~All the tissues that lay in this triangular space (SMA down, CT up, and SMV-PV anterior) is cleared.
~Then the investigators continue the dissection along the right then anterior surface of the SMV and PV until reaching the dissected posterior surface the neck of the pancreas .
~Last step is the division of the neck of the pancreas. After the specimen is removed and before it is sent to the pathology we put mark on each boundary of the specimen one towards SMA, another towards PV/SMV area and the last towards the posterior surface of the mesopancreas."
15955248|NCT03223792|Other|Investigational|Partially-hydrolyzed cow's milk protein infant formula
15955104|NCT03224832|Procedure|Standard Approach|In standard approach after kocharization of the duodenum the investigators start to asses the tunnel under the neck of the pancreas whether tumor infilterating PV/SMV axis and if not we cut the neck of pancreas early in the procedure then we continue to dissect the uncinate process and control pancreatoduodenal vessels and draining lymph nodes and LNS around portal vein and up to hepatic artery and we will add to the standard procedure the previously defined mesopancreatic triangle dissection which lies between SMA caudal, Coeliac artery cranial and PV/SMV axis anterior and the specimen will be marked and sent as previous to pathology.
15955105|NCT03224819|Drug|AMG 673|Open label.
15955106|NCT03224806|Other|Wholegrain bread|156.8g wholegrain bread
15955107|NCT03224806|Other|White bread|122.6g white bread
15955108|NCT03224806|Other|15% fiber-rich bread|139.2g bread made with 15% added wheat bran
15955109|NCT03224806|Other|30% fiber-rich bread|166.5g bread made with 30% added wheat bran
15955110|NCT03224793|Drug|BIIB059|Administered as specified in the treatment arm
15955111|NCT03224793|Drug|Placebo|Administered as specified in the treatment arm
15955112|NCT03224780|Diagnostic Test|maternal serum creatine kinase|Biochemical marker
15955113|NCT03224780|Diagnostic Test|3D Doppler ultrasound|Doppler for placental vessels
15955114|NCT03224767|Drug|Vemurafenib|Given PO
15955115|NCT03224767|Drug|Cobimetinib|Given PO
15955116|NCT03224767|Other|Laboratory Biomarker Analysis|Correlative studies
15955117|NCT03224767|Other|Quality-of-Life Assessment|Ancillary studies
15955118|NCT03224754|Behavioral|Determination of risk of malignancy of these thyroid lesions|This is a retrospective study that will help us to find out the rate of AUS/ FLUS in our population of Mississippi and the percentage of malignancies in these cases.The specimens will be searched through the University of Mississippi Medical Center's Pathology Laboratory Information system (Copath), from April 2010 to December 2016. The retrospective cases will be retrieved using natural language search. The total number of thyroid FNA will be retrieved and the percentage of cases with AUS/ FLUS will be calculated. Followup of these cases will be done looking for additional fine needle aspirations of the thyroid or thyroidectomy specimens. Cases with diagnosis of AUS/ FLUS will have correlation with the diagnosis on the thyroidectomy specimens if available in our system.
15955119|NCT03224741|Behavioral|Monetary Incentive|Subjects in this condition will be read a script informing them of the benefits and importance of routine HIV/AIDS testing for themselves, the benefits for one's partner and loved ones, and for the broader community; they are also given a flyer including the same information.Iin addition, they will be told that if they will get tested for HIV/AIDS within the next two weeks, they will receive $10 (the US dollar became Ecuador's official currency in 2001).
15955120|NCT03224741|Behavioral|Information|Subjects assigned to this condition are read a script informing them of the benefits and importance of routine HIV/AIDS testing for themselves, the benefits for one's partner and loved ones, and for the broader community; they are also given a flyer including the same information. Then, they are invited to get tested in the next two weeks.
15955121|NCT03224741|Behavioral|Active Choice|"Subjects in this condition will receive the same information and flyer as in T1; in addition, they are told that they have the opportunity to express their intention to get tested for HIV/AIDS. To this aim, they will be given a sheet of paper and asked to tick one of two boxes. The first box will say I intend to get tested within the next two weeks, and the second will say I will consider getting tested within the next two weeks but I am not ready to commit at this time. They will also be asked to write their initials at the bottom of the sheet, and will be told to keep it. This is a form of soft commitment which has proven effective in other contexts (Bryan et al. 2010)."
15955122|NCT03224728|Device|intraocular lens|
15955123|NCT03224715|Other|DNA Repair Enzyme Cream|ver-the-counter cosmeceutical. We were going to be using it adjunctively before standard treatment of the actinic cheilitis was done
15955124|NCT03224702|Drug|M6495|Subjects will receive M6495 on Day 1
15955125|NCT03224702|Drug|Placebo|Subjects will receive placebo matched to M6495 on Day 1
15955126|NCT03224689|Device|PEEK-Optima Femoral Component|TKA Surgery
15955127|NCT03224663|Other|Module based learning|self-reading method using learner's guide module on FBNC provided by Department of Pediatrics.administered 45 minutes
15955128|NCT03224663|Other|Mobile application based learning|"learning method using android based mobile application on Facility Based Newborn Care provided by Division of Department of Pediatrics WHO-CC AIIMS FBNC deals with posters , videos , Modules.administered 45 minutes"
15955129|NCT03224637|Procedure|radiofrequency|radiofrequency done in the three genicular nerves upper medial and upper lateral and lower medial
15955130|NCT03224637|Drug|Paracetamol (conventional)|
15955131|NCT03224637|Drug|Ketorolac Tromethamine (conventional)|
15955132|NCT03224624|Other|self-management protocol for hypertension care|participants in this arm will be taught to monitor and record their blood pressure. On a regular basis they will evaluate their blood pressure record and follow an algorithm to decide whether to adjust their medication.
15955133|NCT03224611|Device|light wand|"The light wand is used as a stylet of the flexible LMA. When the investigator inserts the flexible LMA in light wand group, the correct position of the LMA is confirmed by the light."
15955134|NCT03224598|Drug|A-101 Topical Solution 40%|A-101 Topical Solution 40%
15955135|NCT03224585|Drug|Anakinra|"Period 1 (Time 0-72 hours) - this will be an open-label phase during which all subjects meeting enrollment criteria will receive anakinra 100 mg subcutaneously injections daily for 3 days.
~Period 2 (Time 72 hours to 7 days) - anakinra 100 mg subcutaneous injections daily for 4 days"
15955136|NCT03224585|Drug|Placebo|"Period 1 (Time 0-72 hours) - this will be an open-label phase during which all subjects meeting enrollment criteria will receive anakinra 100 mg subcutaneously injections daily for 3 days.
~Period 2 (Time 72 hours to 7 days) - placebo 100 mg saline subcutaneous injections daily for 4 days"
15955137|NCT03224572|Drug|high-dose vitamin C 30gm|High-dose vitamin C 30 gm in 500 ml normal saline, once per week, and total 4-week treatment.
15955138|NCT03224572|Other|normal saline|500ml normal saline, once per week, and total 4-week treatment
15955139|NCT03224559|Device|Transcranial Electrical Stimulation|Transcranial Electrical Stimulation
15955140|NCT03224546|Behavioral|Contingency Management|Subjects will receive payments for providing cocaine negative urine samples.
15955470|NCT03221907|Drug|GLA5PR GLARS-NF1|Pregabalin tablet
15955148|NCT03224494|Device|Rapid Barostat Bag|Both healthy controls (n= 100) and IBS patients (n=100) will undergo anorectal studies using a Rapid barostat bag catheter.
15955149|NCT03224494|Other|IBS severity scoring system questionnaire (IBS-SSS)|We will correlate the changes to IBS symptoms using the IBS severity scoring system questionnaire (IBS-SSS). The questionnaire will be administered twice for IBS patients who have consented to return for a second study visit, at each of the two RBB studies.
15955150|NCT03224494|Other|HAD scale questionnaire|It is a validated anxiety and depression questionnaire
15955151|NCT03224481|Other|Electronic reminder|The frequency and content of the reminders will be informed by the qualitative findings of an ongoing trial, but are likely to include an intra-oral photograph taken pre-treatment and following removal of the active appliances, instructions on the necessary duration of retention, advice on maintenance of retainers, departmental details, advice on appropriate management for appliance breakages, and delineation of the implication of suboptimal retainer wear. Also, information related to the debond visit and maintenance of optimal oral hygiene levels will be incorporated in the mobile application.
15955152|NCT03224468|Drug|Medical Marijuana|Patients in this group can choose when, where, and how much medical marijuana to use.
15955153|NCT03224442|Procedure|PRF|soft tissue augmentation by prf
15955154|NCT03224442|Procedure|Palatal Pedicle|soft tissue augmentation by palatal pedicle
15955155|NCT03224429|Other|Qualitative Interviews Decisional Needs Assessment|Subjects will participate in an open-ended interview regarding type of sickle cell disease, complications, current treatment, and experiences with decision making and sickle cell treatment. Participants will be asked to describe what is important when making health care decisions. Treatment options (hydroxyurea, chronic or monthly blood transfusions, and bone marrow transplantation) will be discussed as well as how a web-based decision aid tool should be developed. The interview will be audio recorded and will take 45 to 60 minutes to complete.
15955156|NCT03224429|Other|Sickle Cell Decision Aid|Participants will be asked to navigate the Sickle Cell Decision Aid site that provides information about risks and benefits of therapies. As the participant navigates the site, the interviewer will ask the participants to describe thoughts about the site, including but not limited to ease of navigation, content and construction. Testing may be performed in-person or via telephone. Interviews will be audio recorded and take up to 60 to 90 minutes to complete.
15955157|NCT03224416|Other|Alcohol Administration|In the alcohol condition (target BrAC = 0.080g%), the participant will be told he is receiving alcohol and will receive beverages of 1:4 parts vodka and tonic water with dashes of lime juice and mint, all mixed in his presence.
15955158|NCT03224416|Other|Placebo Alcohol Administration|"In the placebo condition (target BrAC = 0.000g%), the participant will be told he is receiving alcohol but will receive beverages of 1:4 parts flat tonic water (served from a vodka bottle) and tonic water, with a minimal amount of vodka floated on the surface (using a lime juice bottle) to provide the smell and taste of vodka, with lime juice and mint, all mixed in his presence and served in glasses with vodka-soaked rims."
15955159|NCT03224416|Other|No Alcohol Administration|In the true control (or nonalcohol) condition, the participant will be told he is receiving no alcohol and will be given water (poured in his presence) in a volume comparable to the other conditions.
15955160|NCT03224403|Drug|Test acetaminophen|single dose of 2 Test acetaminophen 500 mg tablets
15955161|NCT03224403|Drug|Commercial acetaminophen|single dose of 2 acetaminophen 500 mg caplets
15955162|NCT03224403|Drug|Commercial ibuprofen|Single dose of 2 ibuprofen 200 mg Liquid-filled Capsules
15955163|NCT03224403|Drug|Placebo|2 placebo caplets
15955164|NCT03224390|Other|digital family planning screening and referral service|Clients text the service and receive a free call back to complete an automated family planning counseling session that results in a set of recommended methods that fit the client's preferences. The client is matched to family planning providers that offer these methods, and the service sends a referral code that the client can redeem at a facility. When someone receives a referral code, the service tracks them through their encounter with a provider to learn about their experience with the service, the provider, and their choice in contraception. The service also follows-up with clients who do not act on referrals to better understand their reasons and tries different behavioral nudges to promote uptake of contraception. The service does not pay costs the client may incur at a facility.
15955165|NCT03224377|Diagnostic Test|anti mutated citrullinated vimentin antibodies|Blood sampling using ELisa technique
15955166|NCT03224364|Procedure|nonsolo LA|This patient is scheduled to undergo nonsolo laparoscpic appendectomy.
15955167|NCT03224364|Procedure|solo LA|This patient is scheduled to undergo solo laparoscpic appendectomy.
15955168|NCT03224351|Drug|VX-659|Tablet for oral administration.
15955169|NCT03224351|Drug|TEZ/IVA|TEZ/IVA fixed-dose combination tablet for oral administration.
15955170|NCT03224351|Drug|IVA|Tablet for oral administration.
15955171|NCT03224351|Drug|Placebo (matched to VX-659/TEZ/IVA)|Placebo matched to VX-659 and TEZ/IVA.
15955172|NCT03224351|Drug|TEZ|Tablet for oral administration.
15955173|NCT03224351|Drug|VX-561|Tablet for oral administration.
15955174|NCT03224351|Drug|Placebo (matched to VX-659/TEZ/VX-561)|Placebo matched to VX-659, TEZ and VX-561.
15955175|NCT03224338|Drug|Dolutegravir 50 mg|Dolutegravir will be used in combination with 2 nucleoside reverse transcriptase inhibitors (NRTIs). The NRTIs used in combination with DTG will be abacavir (ABC) plus lamivudine (3TC) or tenofovir (TDF) plus emtricitabine (FTC), which is in line with the current standard of care. The combination ABC/3TC/DTG will be preferential except in case of hepatitis B co-infection or in case the subject has a positive HLA-B*5701 allele screening assessment.
15955176|NCT03224325|Drug|TAK-831 Tablet T2|Tak-831 tablets.
15955177|NCT03224325|Drug|Placebo|TAK-831 placebo-matching suspension.
15955178|NCT03224325|Drug|TAK-831 Suspension|TAK-831 Suspension.
15955179|NCT03224312|Other|no intervention|no intervention
15955180|NCT03224299|Drug|OCT - clear|Investigational Product #1: octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - clear
15955181|NCT03224299|Drug|OCT- tinted|Investigational product #2: octenidine dihydrochloride in isopropyl alcohol in a single-use applicator - tinted
15955182|NCT03224299|Other|ChloraPrep|Active Control: ChloraPrep® - Hi-Lite Orange® applicator
15955183|NCT03224299|Other|Saline|Negative Control: sterile 0.9% saline applied with single use applicator
15955184|NCT03224286|Device|Pressure sensitive mat|Infant placed on pressure sensitive mat and has physiological parameters recorded.
15955185|NCT03224273|Other|proximal box inlay retained bridge|inlay retained bridge is the less invasive type to restore single missing teeth in the posterior area
15955186|NCT03224260|Drug|BMS-986177|Oral Suspension
15955187|NCT03224260|Other|Matched Placebo|Oral Suspension
15955188|NCT03224247|Procedure|Transverse cutting|Transverse cutting and/or pulling.of lower uterine segment during lower cesarean section extending the uterine incision laterally.
15955189|NCT03224247|Procedure|vertical splitting|vertical splitting of lower uterine segment during lower cesarean section making the direction of traction up and downward instead of being laterally and we suppose that this will allow the tissues to split along their natural arrangement, decreasing the probability of extension of the wound into the uterine vessels, thus; decreasing blood loss; operative time and maternal recovery.
15955190|NCT03224234|Device|Insulclock with feedback|Daily information on a smartphone on insulin administration (time and dosing) as well as reminders in the event of missing doses.
15955191|NCT03224234|Device|Insulclock without feedback|Not feedback on insulin administration.
15955192|NCT03224221|Drug|Apatinib|Patients will receive Apatinib at 500mg/times,oral one times daily for 28 days
15955193|NCT03224221|Drug|fluorouracil and platinum|the dosage of the fluorouracil and platinum need to be determined by the doctors according to the actual condition of the patients
15955194|NCT03224208|Drug|Vemurafenib|Vemurafenib will be orally adminitered at 960 mg b.i.d. on Days 1-28
15955195|NCT03224208|Drug|Cobimetinib|Cobimetinib will be given orally at 60 mg qd on Days 1-21 of each 28-day treatment cycle
15955196|NCT03224182|Drug|Qapzola|Qapzola administered by the intravesical route.
15955197|NCT03224182|Drug|Placebo|Qapzole-matching placebo administered by the intravesical route.
15955198|NCT03224169|Behavioral|Directly observed hand hygiene|Directly observed hand hygiene to the residents and staff
15955199|NCT03224156|Diagnostic Test|Cardiac Magnetic Resonance Imaging|Patients undergo baseline characterisation including CMR, ECG, blood samples prior to ICD implantation.
15955200|NCT03224143|Behavioral|Doll Therapy Intervention|"Daily sessions, lasting an hour, will take place in a room known to patients (P). The only people in the room will be a nurse (N) and the researcher with video-tape, never interacting with P. The procedure is: the N will accompany the P in the room and the P will take a seat. The N will put the doll in front of the P and will say Good morning Mr./Mrs....look, with a quiet voice. If the P will not take it at the first attempt, the N will sit down in front of her holding the doll in the arms and will wait for 2 minutes. The N will invite the PWD again. If the P will not take the doll after the second request, the N will not insist and she will leave. If the doll will be taken, the N will leave the P and say I have to go, goodbye Mr./Mrs. . . ... The gaze will always be upon the P."
15955201|NCT03224143|Behavioral|active control group (SI)|"Daily sessions, lasting an hour, will take place in a room known to patients (P). The only people in the room will be a nurse (N) and the researcher with video-tape, never interacting with P. The procedure is: the N will accompany the P in the room and the P will take a seat. The N will put the cube in front of the P and will say Good morning Mr./Mrs....look, with a quiet voice. If the P will not take it at the first attempt, the N will sit down in front of her holding the cube in the arms and will wait for 2 minutes. The N will invite the PWD again. If the P will not take the cube after the second request, the N will not insist and she will leave. If the cube will be taken, the N will leave the P and say I have to go, goodbye Mr./Mrs. . . ... The gaze will always be upon the P."
15955202|NCT03224130|Other|Nurse Phone Call|We will complete a single center, parallel, randomized, standard-of-care-controlled prospective study to determine the efficacy of a one-time nurse phone call, an intervention adapted from those studied in other populations (i.e., adults, high-risk infants), in improving pediatric patient transitions from hospital to home
15955203|NCT03224130|Other|Standard of Care|Control patients will be randomized to receive standard-of-care at discharge. This care at our institution includes pediatric hospitalist to PCP (primary care physician) verbal and written communication prior to discharge, written documentation for the family regarding prescribed medication regimen, recommended follow-up with outpatient PCP and relevant consultant(s), and delivery of prescribed medications from the hospital pharmacy to the patient's bedside.
15955204|NCT03224117|Drug|DWJ211|inject the Drug into submental fat via subcutaneous
15955205|NCT03224117|Drug|Normal saline|inject the Drug into submental fat via subcutaneous
15955206|NCT03224104|Drug|TG02|"The initial cohorts of Groups A and B will receive TG02 at 200 mg on intermittent schedules in combination with either RT or TMZ. TG02 will be escalated to 250 mg if the dose decision criteria are met in the first cohort.
~The initial cohort in Group C will receive TG02 alone at 250 mg on intermittent schedules. It will be continued at this dose if feasible or decreased to 200 or 150 mg if not tolerated."
15955207|NCT03224104|Radiation|Radiation Therapy|For group A standard involved-field hypofractionated RT will be administered at 39.9 Gy in 15 fractions of 2.66 Gy for 3 weeks
15955208|NCT03224104|Drug|Temozolomide|For group B TMZ will be given in the standard 28-day cycle regimen (150-200 mg/m2) for 5 days.
15955209|NCT03224078|Other|data extraction|No Special interventions except from data extraction form the respective routine data sources are planned .
15955210|NCT03224065|Diagnostic Test|Genotype detected through GenSeizer high-throughput gene capture technology|The sputum and/or alveolar lavage fluid of the optimal treatment group was first identified by GenSeizer, which was used to remove the resistant agents and choose the sensitive agents, so as to optimize the initial antimicrobial program. All agents are within the recommended range of 2007 ATS / IDSA Guidelines. All treatment regimens need to be corrected in time according to the final results of culture and in vitro susceptibility testing.
15955211|NCT03224039|Drug|Sufentanil|Intranasal for one dose (experimental)
15955212|NCT03224039|Drug|Normal saline|Intravenous for one dose as placebo (to be administered with sufentanil or morphine arm as part of double-blinding). If patients are randomized to receive IN sufentanil, they will also receive IV normal saline. If patients are randomized to receive IV morphine, they will also receive IN normal saline.
15955213|NCT03224039|Drug|Morphine|intravenous push for one dose (active comparator)
15955249|NCT03223779|Drug|TAS-102|Trifluridine stops DNA replication which may prevent the cancer cells from growing
15955347|NCT03222960|Drug|propolis-containing toothpaste|participants will use propolis-containing toothpaste for 6 months
15955214|NCT03224013|Procedure|LASIK|LASIK with concurrent prophylactic high fluence crosslinking in right eye ( After the excimer laser ablation, and with the flap folded onto itself and protected with a dry sponge, one drop of Vibex Rapid™ , consisting of 0.10% saline-diluted riboflavin (a very slightly hypotonic solution, mixed with hydroxypropyl methylcellulose, a dextran substitute), was placed on the exposed stromal bed afforded by the open LASIK flap and carefully spread over the bed area with an irrigating cannula for 60 seconds and LASIK only in left eye
15955215|NCT03224000|Procedure|Modified Barium Swallow (MBS)|Modified barium swallow (MBS) performed at baseline and at 6 months, 2 years, and 5 years after finishing radiation therapy.
15955216|NCT03224000|Behavioral|Swallowing Questionnaire|Swallowing questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
15955217|NCT03224000|Behavioral|Symptom Questionnaire|Symptom questionnaire completed at baseline, every week while receiving radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
15955218|NCT03224000|Procedure|Video-Strobe Procedure|Video-strobe procedure to check vocal cords performed at baseline, at week 3 during radiation therapy, and at 6 months, 2 years, and 5 years after finishing radiation therapy.
15955219|NCT03224000|Procedure|MRI Guided Intensity Modulated Radiotherapy (IMRT) Planning|IMRT planned with MRI guidance.
15955220|NCT03224000|Procedure|Standard-of-Care Intensity Modulated Radiotherapy (IMRT) Planning|IMRT planned by standard-of-care.
15955221|NCT03224000|Radiation|Intensity Modulated Radiotherapy (IMRT)|Participants receive an individualized prescription of up to 70 Gy in 33 fractions with radiation therapy (RT) given once daily, 5 days a week, over 6 weeks and 3 days.
15955222|NCT03223987|Dietary Supplement|Strath® Kräuterhefe Original (liquid)|"The food supplement is taken 3 x 1 coffee spoon à 5ml = 15ml per day for three weeks.
~Stool analysis at 2nd visit and last visit. Before-after study."
15955223|NCT03223974|Device|Paclitaxel DCB|Balloon/vessel diameter ratio 0.8-1.0, 8-10 ATM, lasting for >30 seconds. If quantitative coronary angiography determines residual stenosis ≤ 30% , it is considered to be a successful operation.
15955224|NCT03223974|Device|DES|MB should be sufficiently predilated to facilitate the positioning of the stent and the stent residual stenosis should be ≤10% to be a successful operation.
15955225|NCT03223961|Drug|EPREX|60 000 U/week for at least 12 weeks
15955226|NCT03223948|Device|'Optiflow'|High flow nasal oxygen delivery device 'Optiflow'
15955227|NCT03223935|Other|Corn nuts|Roasted corn nut snack
15955228|NCT03223935|Other|Chickpeas|Roasted chickpea snack
15955229|NCT03223935|Other|Yellow peas|Roasted yellow pea snack
15955230|NCT03223935|Other|Pinto beans|Roasted pinto bean snack
15955231|NCT03223935|Other|Soybeans|Roasted soybean snack
15955232|NCT03223935|Other|Almonds|Roasted almond snack
15955233|NCT03223922|Radiation|whole brain radiation therapy|Corpus Callosum Genu-Sparing Whole Brain Radiation Therapy Genu-sparing whole brain radiation therapy (GS-WBRT) 30 Gy in 3 Gy per fraction
15955234|NCT03223909|Drug|PRO-087|0.1% sodium hyaluronate, free-preservative 0.18% chondroitin sulphate
15955235|NCT03223909|Drug|Systane Ultra|Is a sterile solution containing polyethylene glycol 400, propylene glycol, hydroxypropyl-guar, sorbitol, aminomethylpropanol, boric acid, potassium chloride, sodium chloride and POLYQUAD® (poly-hydronium chloride) 0.001% as preservative.
15955236|NCT03223909|Drug|Systane Ultra Preservative Free|Polyethylene Glycol 400 0.4%Lubricant, Propylene Glycol 0.3% Lubricant,
15955237|NCT03223896|Drug|Naloxone hydrochloride 20mg/ml|Nasal spray
15955238|NCT03223883|Drug|Curcumin|Oral supplement for 12 months
15955239|NCT03223883|Other|Placebo|Oral placebo for 12 months
15955240|NCT03223870|Diagnostic Test|Diagnostic|Diagnostic
15955241|NCT03223857|Procedure|Femtosecond-laser-assisted lens exchange|Bilateral implantation of multifocal intraocular lens (MIOL) following femtosecond-laser-assisted lens exchange
15955242|NCT03223844|Drug|Dextroamphetamine Sulfate|Repeated oral administration of dexamphetamine 0.4mg/KG bodyweight four times.
15955243|NCT03223831|Other|Partially covered pyloro-duodenal stent|The PCDS (Niti-S COMVITM - Flare, Taewoong, Gyeonggi-do, South Korea) used in the current study is a partially covered metallic pyloro-duodenal stent. It consists of two portions (Figure 1). The stent is 2cm in diameter and the proximal 2cm of the stent is uncovered and flared. This is designed to provide anchorage of the stent to surrounding tissue and reduce the risk of migration. The remaining of the stent is covered, where a polytetrafluoroethylene (PTFE) membrane is held between two nitinol mesh to prevent the risk of tumour ingrowth into the stent. The stents come in lengths of 6, 8, 10 & 12cm.
15955244|NCT03223831|Other|Uncovered pyloro-duodenal stents|The UCDS (Niti-S pyloric-duodenal D stent, Taewoong, Gyeonggi-do, South Korea) used in the current study is an uncovered stent made of nitinol wire, with a diameter of 20mm and length of 6,8,10,12cm. This stent is an unfixed-cell braided stent with low axial force, high flexibility and good conformability.
15955245|NCT03223818|Other|Fast-track peri-operative program|"Patients who are scheduled for elective liver resection will be screened in clinic or in wards for the eligibility for ERAS program. Patient will then visit a nurse-led clinic for pre-operative assessment of risk adjustment and education. A guided tour on surgical ward and an information booklet about preoperative management will be given.
~All patients will receive local infiltration of local anaesthesia (0.25% levobupivacaine) followed by continuous wound instillation using the On-Q PainBuster System balloon pump. Pain control will be supplemented by using opioid-sparing multimodal analgesia."
15955246|NCT03223805|Other|Respiratory Distress Symptom Intervention|"The RDSI comprises of four components
~Controlled breathing techniques - consists of diaphragmatic breathing exercises and calming techniques practised twice a day and used as needed for episodes of intense breathlessness and/or anxiety
~Cough suppression techniques - includes education (capacity for voluntary cough easing, identifying warning signs for cough and replace with modified swallow technique or relaxed throat breath
~Acupressure: a small number of acupressure points are taught: L7, L9, LI4 (located on the hand and wrist areas), CV21 and 22 (sternum), and ST36 (knee). Patients can select any of these points in any combination to apply pressure for one-minute at least twice a day for symptom relief
~Exercise: Individually-tailored exercise plan, for example, walking incrementally increasing distances in their local environment, incorporating breathing techniques as required"
15955247|NCT03223792|Other|Control|Routine cow's milk-based infant formula
15955250|NCT03223779|Radiation|Photon SBRT|SBRT stands for Stereotactic Body Radiation Therapy. Radiation may help to kill the cancer cells while protecting your normal tissue cells
15955258|NCT03223740|Other|Arm 1 pre-operative chemoradiation|"Chemotherapy 1:
~First 2 courses of chemotherapy with the Capacitabine /cisplatin/ combination.Capacitabine1 g/me2 day 1 to 14. Cisplatin will be given at 20 mg/m2 as a one-hour bolus on day1-5.
~Chemoradiotherapy:
~At the end of the second 21 days of chemotherapy and one week of rest (day 57), a total of 45 Gy(1.8 Gyfx/d) of radiotherapy will be given with concurrent capacitabine 625 mg/m2 and weekly Taxol 45mg/m2 over 3 hours for 5 weeks.
~Chemotherapy2:
~Four to five weeks after chemoradiotherapy, Restaged and surgical resection, a D2 resection is encouraged. Peritoneal cytology will be obtained. The J-tube will be left in for at least 8 weeks after surgery to supplement patient's nutrition.
~2nd courses of chemotherapy with the Capacitabine. Capacitabine1 g/me2 day 1 to 14. Chemotherapy will be repeated beginning on Day 29."
15955259|NCT03223740|Other|Arm 2 post operative chemoradiation|"Surgical resection, a D2 resection is encouraged.
~Chemotherapy 1:
~All patients will first receive two courses of chemotherapy with the Capacitabin /cisplatin/ combination.Capacitabine1 g/me2 day 1 to 14. Cisplatin will be given at 20 mg/m2 as a bolus on day1-5. Chemotherapywill be repeated beginning on Day 22.
~Chemoradiotherapy:
~At the end of the second 21 days of chemotherapy and one week of rest (day 57), a total of 45 Gy(1.8 Gyfx/d) of radiotherapy will be given with concurrent capacitabine 625 mg/m2 and weekly Taxol 45mg/m2 over 3 hours for 5 weeks.
~Chemotherapy2:
~2nd courses of chemotherapy with the Capacitabin. Capacitabine 1g/me2 day 1 to 14. Chemotherapy will be repeated beginning on Day 29"
15955260|NCT03223727|Diagnostic Test|Blood tests|Blood tests for several bone markers (see summary)
15955261|NCT03223714|Drug|Conbercept Ophthalmic Injection|
15955262|NCT03223714|Drug|sham injection|
15955263|NCT03223701|Combination Product|Solum IV, Bone Marrow Concentrate with general fluid concentrate (GFC) in Transforaminal Lumbar Interbody Fusion|The bone marrow aspirate (BMA) will be taken from the iliac crest of the enrolled subjects. The BMA will be transferred to a processor that will use ART BMC Plus (Celling Biosciences, Austin, TX) platform technology to obtain the BMC preparation. The plasma component that remains as a by-product of generating the BMC will then be concentrated by the ART BMC Plus device to create a concentrated plasma/general fluid concentrate (GFC). The enrolled subjects' BMC and GFC will be provided to the principle investigator who will combine the two together with Solum IV using the Graft Delivery Kit (Celling Biosciences) and perform a TLIF procedure. (See Appendix B for Graft Delivery Kit). All subjects will be assigned to receive lumbar interbody fusion via a TLIF approach with Solum IV bone graft and BMC with GFC in the interbody space of a TLIF using cynch bullet cage (@SpineSmith) and Stryker based pedicle screw system (Xia 3 system).
15955264|NCT03223688|Behavioral|Day-Care early intervention program|The daily treatment session had eight children along with their major caregivers. The treatment was conducted by two experienced occupational therapists (OT), and each session lasted for four hours in the week-day morning with a 10-minute break. The goal of the sessions was to enhance children's development through cognitive training, behavioral modification plan and parenting skill training.
15955265|NCT03223688|Behavioral|OPD+SI intervention program|The treatment program had eight children along with their major caregivers. The treatment was also performed by two experienced OT, and each session lasted for one hours, once a week. The sessions consisted of cognitive training, behavioral modification plan and parenting skill training. Adjunctive SI therapy was also performed by said OT for improving children's sensory motor development in an additional hour.
15955266|NCT03223688|Behavioral|OPD intervention program|The treatment program had eight children along with their major caregivers. The treatment was also performed by two experienced OT, and each session lasted for one hours, once a week. The sessions consisted of cognitive training, behavioral modification plan and parenting skill training.
15955267|NCT03223675|Radiation|hippocampal-sparing WBRT|
15955268|NCT03223662|Other|Chemoradiotherapy|Chemotherapy: Carboplatin (AUC=2)x5 and Paclitaxel (50 mg/m(2))x5 for two cycles. Radiation: a total dose of 40.4 Gray (Gy) will be given in 23 fractions of 1.8 Gy, 5 fractions per week, starting the first day of the first cycle of chemotherapy.
15955269|NCT03223662|Procedure|Esophagectomy|Minimally-invasive esophagectomy (RAMIE) or traditional open approach if necessary.
15955270|NCT03223649|Other|Walking Bouts|Six daily 3 hour sessions with prompted 3-minute moderate-intensity walking bouts performed on a treadmill every 30 minutes throughout the 3 hour duration. There will be a total of 6 walking bouts (18 minutes total) each day. Moderate-intensity walking speed and grade will be selected to achieve 80% of the heart rate achieved at the ventilatory threshold as determined during a V02max test.
15955271|NCT03223649|Other|Sedentary|(Control 'intervention') Six daily 3 hour sessions with no physical activity (i.e. subject remains sedentary in seated or recumbent position) throughout the 3 hour duration.
15955272|NCT03223636|Device|TMS|We will use TMS with paired-pulse technique to activate corticospinal neurons in the primary motor cortex and motorneurons in the brainstem, respectively (Hallett 2007; Ugawa et al. 1991; Ugawa et al.1994). Two stimulations will be separated with various interstimulus intervals to produce collision on nerve fibers with different conduction velocity in the corticospinal tract. The conduction time on nerve fibers in the corticospinal tract with different conduction velocity will be identified and the distribution of these fibers will be calculated.
15955273|NCT03223636|Device|MRI|MRI exams will consist of several sessions including calibration, anatomic, and diffusion MRI scanning (Avram et al. 2013; Avram et al. 2016; Pierpaoli et al. 1996). Data in each exam will be acquired in the left or right forearm (PNS).
15955274|NCT03223623|Device|TMS|Single pulse TMS, IPL-M1 Interaction, IPL-M1 Interaction, Inhibitory Theta Burst Protocol (cTBS)
15955275|NCT03223623|Device|MRI|High-resolution MRI for anatomical reference; fMRI scan as per research fMRI protocol will be conducted under 3 conditions. 1. Rest 2. Voluntary activity 3. Motor imagery task.
15955276|NCT03223623|Device|VASO Imaging|The voluntary activity condition will involve 4 tasks: a. individual tapping of two fingers (index and little), b. individual tapping of four fingers (index, middle, ring, and little; no thumb) interspaced with rest periods, c. individual tapping of all five fingers (index, middle, ring, little, and thumb) interspaced with rest periods and d. Alternating grasping or retraction of a rubber ball interspaced with rest periods.
15955277|NCT03223610|Drug|Venetoclax|Administered orally, days 2-14, at varying doses of 200-800 mg (based upon assigned dose level); every 21 days for up to 6 cycles, or until disease progression or unacceptable toxicity
15955278|NCT03223610|Drug|Ibrutinib|Administered orally, days 1-14, at a dose of 560 mg; every 21 days for up to 6 cycles, or until disease progression or unacceptable toxicity
15955279|NCT03223610|Drug|Prednisone|Administered orally, days 1-7, at a dose of 100 mg; every 21 days for up to 6 cycles, or until disease progression or unacceptable toxicity
15955280|NCT03223610|Biological|Obinutuzumab|Administered intraveneously, days 1 and 2, at a dose of 1000 mg; every 21 days for up to 6 cycles, or until disease progression or unacceptable toxicity
15955281|NCT03223610|Drug|Revlimid (lenalidomide)|Administered orally, days 1-15, at a dose of 15 mg; every 21 days for up to 6 cycles, or until disease progression or unacceptable toxicity
15955282|NCT03223597|Drug|Radium-223 dichloride|Registry of patients who receive Radium-223.
15955283|NCT03223571|Other|Motor rehabilitation training|Post-stroke participants receive 6 week of rehabilitation training of the paretic upper-limb.
15955284|NCT03223558|Behavioral|timing of initiation of cardiac rehabilitation|earlier timing of cardiac rehabilitation
15955285|NCT03223545|Behavioral|MBCT-T|This 8-week program combines mindfulness training with cognitive therapy and is delivered to small groups of patients by telephone using a conference line. Each weekly session is 1 hour long and is comprised of a check-in period, teaching on the week's topic, group discussion, a skill-building exercise, and a home-based practice assignment.
15955286|NCT03223545|Behavioral|Usual Care|"Treatment guidelines recommend counseling patients with prehypertension on the importance of lifestyle modification to reduce BP. Because of variability in counseling across primary care practices, the study team will provide all participants with NHLBI print educational materials to ensure exposure to lifestyle recommendations: Your Guide to Lowering Blood Pressure; and Facts about the DASH Eating Plan."
15955287|NCT03223532|Device|PrePex Day 7 FRP|Standard PrePex procedure, foreskin and device are removed 1 week after device application.
15955288|NCT03223532|Device|PrePex Day 0 FRP|Removal of the foreskin shortly after device application, the device is removed 1 week later
15955289|NCT03223519|Drug|Comboprofen|Triple combination of Ibuprofen, Magnesium and Vitamin C Powder for oral solution administered TID for 3 days
15955290|NCT03223519|Drug|Placebo|Powder for oral solution administered TID for 3 days
15955291|NCT03223519|Drug|Ibuprofen|Powder for oral solution administered TID for 3 days
15955292|NCT03223519|Drug|Magnesium|Powder for oral solution administered TID for 3 days
15955293|NCT03223519|Drug|Vitamin C|Powder for oral solution administered TID for 3 days
15955294|NCT03223506|Drug|Paracetamol|
15955295|NCT03223493|Other|No treatment given|Completion of a questionnaire
15955296|NCT03223480|Device|EUS-guided gastrojejunstomy|As listed in the arms description
15955297|NCT03223467|Procedure|Bariatric surgery|Bariatric surgery includes several different types of surgical procedures used to achieve weight loss.
15955298|NCT03223454|Biological|hAECs|hAECs are provided by Chongqing iCELL Biotechnology Co.,Ltd., which is a subsidiary of Shanghai iCELL Biotechnology Co.,Ltd. The participants are blind to their arms because the surgery is done under anesthesia. After hysteroscopic adhesiolysis, subsequently oral antibiotics will be given for 3 days to prevent infection. Estrogen will be administrated for 3 cycles to stimulate the repair of endometrium after the surgery.
15955299|NCT03223454|Biological|biological amnion|Biological amnion is purchased from JiangXi RuiJi BioTechnology Co.,Ltd. The participants are blind to their arms because the surgery is done under anesthesia. After hysteroscopic adhesiolysis, subsequently oral antibiotics will be given for 3 days to prevent infection. Estrogen will be administrated for 3 cycles to stimulate the repair of endometrium after the surgery.
15955300|NCT03223428|Drug|Xermelo|This study will include patients with carcinoid syndrome who are initiating treatment with XERMELO.
15955301|NCT03223415|Other|Detection and isolation of C. difficile carriers|"Screening for C. difficile carriage will be conducted by performing a polymerase chain reaction (PCR) assay detecting the toxin B gene (tcdB) on a rectal swab. Screening will occur within 24 h of admission to the ward. To ensure compliance with the policy, automatic orders will be developed. The patient care nurse will perform the screenings. The results will be reported according to the standard institutional policy.
~Isolation precautions for C. difficile carriers: healthcare workers will also follow a set of isolation precaution rules during the care of C. difficile carriers. C. difficile carriers will remain under isolation precaution as long as they remain carriers and on the intervention ward. Precautions would be discontinued upon discharge from the ward."
15955302|NCT03223402|Other|Nevirapine plus lamivudine|In this Pilot study, the efficacy of a bi-therapy consisting of NVP+3TC instead of NVP+2NRTI should be evaluated before a large multicenter study evaluating this combination is started.
15955303|NCT03223389|Dietary Supplement|C-8 dietary oil|Ingestion of 13.15 g C-8 dietary oil providing 0.0216 mol of triglycerides.
15955304|NCT03223389|Dietary Supplement|Tricaprylin|Ingestion of 10.17 g tricaprylin providing 0.0216 mol of triglycerides.
15955305|NCT03223389|Dietary Supplement|Olive oil|Ingestion of 19 g olive oil providing 0.0216 mol of triglycerides.
15955306|NCT03223376|Combination Product|fruquintinib +paclitaxel|treatment arm(fruquintinib +paclitaxel)- subjects will receive Fruquintinib orally, once daily for 3 wks on/ 1 wk off combined with paclitaxel 80mg/m2 at day 1,8,15 of 4-week cycle. Patients will receive a cycles of 4 weeks of study treatment or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment cretieria
15955307|NCT03223376|Combination Product|fruquintinib placebo + paclitaxel|control arm(fruquintinib placebo + paclitaxel)- subjects will receive Fruquintinib placebo orally, once daily for 3 wks on/ 1 wk off combined with paclitaxel 80mg/m2 at day 1,8,15 of 4-week cycle. Patients will receive a cycles of 4 weeks of study treatment or until the occurrence of progressive disease (PD), death, unacceptable toxicity, withdrawal of consent or other conditions that meet the end of treatment cretieria
15955308|NCT03223363|Diagnostic Test|2D and 3D ultrasonography|All of the examinations are performed with the same transabdominal ultrasonic transducer (RAB 2-5-D) on the same E8 (GE Medical Systems, Milwaukee, WI, USA) ultrasonic machine experienced operators. 2D ultrasonic measurements includes 5 standard fetal biometry parameters, and after routine 2D ultrasonography, the acquisition of 3D measurements are performed.
15955309|NCT03223350|Drug|Capsaicin 0.1% Cream|Topical application
15955310|NCT03223350|Drug|Placebos|placebo cream
15955311|NCT03223337|Drug|Daprodustat (GSK1278863)|Daprodustat (GSK1278863) 6 mg tablet will be given to all subjects as a single dose via oral route. Daprodustat (GSK1278863) is a 9.0 millimeter (mm) round, compound radius, white film coated tablet.
15955312|NCT03223324|Device|abdominal fetal/maternal monitor|A single passive patch placed on the abdomen that incorporates 5 electrodes and a monitoring device
15955315|NCT03223285|Behavioral|Real Treatment Group|"Real Diaphragm manoeuvres The experimental manoeuvres include the Doming The Diaphragm Technique as described by Digiovanna (2004), Chila (2011) and Yao (2014) and the Manual Diaphragm Release Technique as described by Ricard (2009), De Coster (2005) and Roha (2015). Both manoeuvres are performed in two sets of 10 repetitions, within a 1-minute interval.
~Multifaced physiotherapy/osteopathic treatment includes: vertebral mobilisations (C0-D1), high-velocity low-amplitude (HVLA) thrusts of the cervical spine, soft tissue techniques"
15955316|NCT03223285|Behavioral|Sham Treatment Group|"Sham Diaphragm manoeuvre: the physiotherapist will simply lie hands on the rib cage, and rest along the anterolateral costal margin below rib 7, during normal breathing of the patient for 40 breathes.
~Multifaced physiotherapy/osteopathic treatment includes: vertebral mobilisations (C0-D1), high-velocity low-amplitude (HVLA) thrusts of the cervical spine, soft tissue techniques"
15955317|NCT03223272|Drug|Reserpine|Open label reserpine 0.1 mg pill orally
15955318|NCT03223259|Behavioral|Injury Prevention Workshops|Each workshop will last 90 minutes and consist of approximately 20-30 minutes of lecture, 30 minutes of movement, no more than 20 minutes for a pre-test (workshop 1) or post-test (workshop 2), and remaining time for Q&A.
15955319|NCT03223246|Other|Additional teaching|A brief safety intervention, combining a pictorial handout, dosing demonstration with dispensed syringe, and teach-back for confirmation of understanding.
15955320|NCT03223233|Other|procalcitonin level|serum procalcitonin level will be measured in both groups.
15955321|NCT03223220|Drug|Ketamine|IV infusion
15955322|NCT03223220|Other|Normal Saline|IV infusion
15955323|NCT03223220|Drug|Midazolam injection|Injection
15955324|NCT03223194|Genetic|AT342|AT342 is an AAV8 vector containing a functional copy of the UGT1A1 gene.
15955325|NCT03223168|Device|Hayek RTX ventilator|Participants will receive Noninvasive negative pressure from the Hayek RTX ventilator for 30 minutes during diagnostic catheterization procedure.
15955326|NCT03223155|Drug|Nivolumab|"Patients in Sequential Arm will begin treatment with nivolumab (given with ipilimumab) between 1-7 days after completion of SBRT.
~Patients in Concurrent arm will begin treatment with nivolumab (given with ipilimumab) first and will continue treatment within 2 weeks, after completion of SBRT to 2-4 sites.
~In both arms, patients will receive treatment with nivolumab 3 mg/kg as a 30-minute infusion +/- 10 minutes every 2 weeks for a maximum of 24 months. Patients will receive treatment on days 1, 15, and 29 of each 6 week cycle."
15955327|NCT03223155|Drug|Ipilimumab|"Patients in Sequential Arm will begin treatment with ipilimumab (given with nivolumab) between 1-7 days after completion of SBRT.
~Patients in Concurrent arm will begin treatment with ipilimumab (given with nivolumab) first and will continue treatment within 2 weeks, after completion of SBRT to 2-4 sites.
~In both arms, patients will receive treatment with ipilimumab 1 mg/kg as a 30-minute +/- 10 minutes infusion every 6 weeks for a maximum of 24 months. Patients will receive treatment on day 1 of each 6 week cycle."
15955328|NCT03223155|Radiation|Stereotactic body radiation therapy|All patients will receive 3 or 5 fractions of radiation as determined by the location of the lesions to be irradiated. There should be a minimum of 40 hours between treatments for an individual lesion. However, a patient may receive radiation for different lesions on consecutive days. Starting dose depends on metastasis locations.
15955329|NCT03223142|Device|Multi-modal Precision Ablation|In Multi-modal Precision Ablation group, patients received Image-guided cryoablation immediately followed by radiofrequency ablation
15955330|NCT03223129|Other|Oral glucose tolerance test|Oral glucose tolerance tests were glucose is administrated orally with an increasing load (25g, 75g, 100 g)
15955331|NCT03223129|Other|Graded intravenous glucose infusion|Graded intravenous glucose infusion where glucose is infused in order to receive an plasma glucose pattern comparable to those received during the oral glucose tolerance tests.
15955332|NCT03223116|Procedure|Radiofrequency delivery|Radiofrequency to the gastroesophageal junction
15955333|NCT03223103|Drug|Poly-ICLC|Poly-ICLC 100mcg per peptide per dose
15955334|NCT03223103|Device|Tumor Treating Fields|an FDA approved treatment for patients with recurrent GBM and newly diagnosed GBM
15955335|NCT03223103|Biological|Peptides|synthetic long peptides (SLP) as vaccine substrate
15955336|NCT03223090|Behavioral|Tool-use|Motor training with a tool during max 5 weeks (3 days per week, around 30 minutes per day)
15955337|NCT03223090|Behavioral|Hand|Motor training with the right hand during max 5 weeks (3 days per week, around 30 minutes per day)
15955338|NCT03223064|Diagnostic Test|Ferumoxtran-10 enhanced MRI; MRI contrast agent|Patient undergo MRI with an USPIO contrast agent
15955339|NCT03223064|Diagnostic Test|68Ga PSMA PET-CT|Patient undergo an 68Ga PSMA PET-CT scan
15955340|NCT03223051|Other|Motor assessment|An occupational therapist install the patient sitting in front of the test board and tell him the instructions
15955341|NCT03223038|Other|No intervention|No intervention - exposure is mechanical ventilation in PICU
15955342|NCT03223025|Drug|CinnaTropin®|0.03 mg/kg daily subcutaneous injections
15955343|NCT03223025|Drug|Nordilet®|0.03 mg/kg daily subcutaneous injections
15955344|NCT03222999|Other|No intervention planned|No intervention planned
15955345|NCT03222973|Drug|BIIB033 (opicinumab)|Administered as specified in the treatment arm
15955346|NCT03222973|Drug|Placebo|Administered as specified in the treatment arm
15955348|NCT03222960|Drug|Fluoride-containing toothpaste|participants will use Fluoride-containing toothpaste for 6 months
15955349|NCT03222947|Genetic|Deoxyribonucleic acid analysis|This study consists in the high throughput exome sequencing and subsequent genetic bio-analysis of 19 deoxyribonucleic acid samples from 6 families, already collected and consented, including patients diagnosed with a Taybi-Linder syndrome and their relatives (parents and/or siblings).
15955350|NCT03222934|Device|multislice computed tomography|radiological diagnosis of the status and variations in the sphenoid sinus
15955351|NCT03222921|Procedure|High tibial osteotomy|Patients undergoing high tibial osteotomy are investigated by a pressure insole for post-operative weight bearing behavior
15955352|NCT03222908|Behavioral|Intervention1: Contract Agreement|Smoking Cessation Contract
15955353|NCT03222908|Behavioral|Intervention2: Implementation Intentions|Smoking Cessation Contract with worksheet for implementation intentions
15955354|NCT03222882|Procedure|personal embryo transfer|According to the histological dating and transcriptomic profile of endometrium of hormone replacement cycle in control group, to explore the effectiveness of intervention by advanced or delayed personal embryo transfer . The establishment of standard control group: Frozen embryo transfer patients according to the inclusion and exclusion criteria were evaluated for histological dating and transcriptomic profile by endometrial biopsy on day P＋7 in an HRT cycle. After routine time transfer in the frozen embryo transfer cycle, the standard of histological dating and transcriptomic profile were determined according to the pregnancy outcome of the FET cycle .
15955355|NCT03222869|Diagnostic Test|Measure Airway Resistance Across Stenosis|Measure pressure and air flow Across Stenosis
15955356|NCT03222856|Drug|Pembrolizumab|MK3475 (pembrolizumab) will be supplied directly as a solution for infusion in a single-use vial. Each vial contains 100 mg of MK3475 (pembrolizumab) in 4 ml of solution.
15955357|NCT03222856|Drug|Eribulin|Eribulin will be supplied as a clear and colourless aqueous solution for injection provided in glass vials containing 2 ml. Each 2 ml vial contains eribulin mesylate equivalent to 0.88 mg eribulin.
15955358|NCT03222843|Drug|Hetrombopag Olamine|once daily
15955359|NCT03222843|Drug|matching placebo|once daily
15955360|NCT03222830|Procedure|personal embryo transfer|"According to the histological dating and transcriptomic profile of endometrium of natural cycle in control group, to explore the effectiveness of intervention by advanced or delayed personal embryo transfer .
~The establishment of standard control group: Frozen embryo transfer patients according to the inclusion and exclusion criteria were evaluated for histological dating and transcriptomic profile by endometrial biopsy on 7 days after ovulation. After routine time transfer in the frozen embryo transfer cycle, the standard of histological dating and transcriptomic profile were determined according to the pregnancy. outcome of the FET cycle ."
15955361|NCT03222817|Behavioral|HPV self-sampling|Participants will be provided with education regarding cervical cancer screening, as well as instructions regarding how to use the HPV self-sampler. Participants will also receive referrals to trans-competent healthcare providers for follow-up screening and care.
15955362|NCT03222804|Dietary Supplement|Bifidobacterium|Each B. infantis (strain: BIEVC001) dose will be provided in one 625 mg sachet delivering 156 mg of live bacteria at a dose of 9x10^9 CFU plus 469 mg of pharmaceutical-grade lactose as the excipient and dispensed to participants by the study personnel.
15955363|NCT03222791|Other|Algorithm-based diet|Personalized nutrition plan based on an algorithm for predicting the personalized glucose response to food. The algorithm's predictions are based on many personal measurements, including blood tests, personal lifestyle and gut bacteria.
15955364|NCT03222791|Other|Mediterranean-style low-fat diet|The Israeli standard of care dietary guidelines for prediabetes.
15955365|NCT03222765|Drug|Placebo, metformin, linagliptin, linagliptin + metformin|
15955366|NCT03222752|Device|Cranial Electrotherapy Stimulation|Alpha-Stim® AID microcurrent and cranial electrotherapy stimulator will be used. Daily one hour cranial electrotherapy stimulation (CES) treatment using ear clip electrodes with current set at fixed level of 100 uA (a subsensory current level), 0.5 Hertz will be used for active CES treatment group for 6 weeks. For the sham group the Alpha-Stim® AID ear clips will not emit electricity.
15955367|NCT03222752|Device|Sham Cranial Electrotherapy Stimulation|The sham treatment will be using a sham Alpha-Stim AID which will look and sound exactly like the active treatment but will deliver no current.
15955368|NCT03222739|Device|Ultrasound|An industry standard ultrasound will be fitted with a self-tracking probe to track along the spine. The ultrasound will be performed three (3) times along the spine at initial consultation for scoliosis.
15955369|NCT03222726|Other|exercise group|less than 6000 steps/day or 40,000 steps/week
15955370|NCT03222713|Other|Program Self-regulation in health|The intervention program with children will be run by teachers and health professionals (Condition Group II) in 50-minute biweekly sessions which will take place in class in school year. During these sessions, the children will complete the following tasks: the reading of the chapters of Yellow Trials and Tribulations (one chapter per week) and the discussions and activities related to the topics of healthy eating and oral health.
15955371|NCT03222700|Procedure|surgical procedure|In robotic thyroidectomy group, patients are received surgery using robotic system. In open thyroidectomy group, patients are received conventional open surgery.
15955372|NCT03222687|Drug|tacrolimus|Immunosuppressive therapy included tacrolimus and prednisone. Tacrolimus treatment was initiated at a dosage of 0.05-0.1 mg/kg/day twice daily and used for at least 6 month. Prednisone was started at 2 mg/kg/day and tapered off gradually after initiation of treatment.
15955373|NCT03222687|Drug|prednisone|Immunosuppressive therapy included tacrolimus and prednisone. Tacrolimus treatment was initiated at a dosage of 0.05-0.1 mg/kg/day twice daily and used for at least 6 month. Prednisone was started at 2 mg/kg/day and tapered off gradually after initiation of treatment.
15955374|NCT03222674|Biological|Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells|Infusion of Muc1/CLL1/CD33/CD38/CD56/CD123-specific gene-engineered T cells
15955375|NCT03222661|Diagnostic Test|Refraction|Refractive error measurement
15955378|NCT03222635|Procedure|Endoscopic follow-up|Endoscopic follow-up by means of regular upper endoscopies and endoscopic ultrasounds
15955380|NCT03222622|Drug|Placebo cream|Apply topically twice daily for 12 consecutive weeks
15955381|NCT03222609|Drug|Ruxolitinib|Tablet; Oral
15955382|NCT03222609|Drug|Navitoclax|Tablet; Oral
15955383|NCT03222596|Behavioral|Exercise training|Exercise programme includes breathing and upper limbs exercises.
15955384|NCT03222583|Drug|Placebo|Matching placebo tablet for oral administration
15955385|NCT03222583|Drug|Glecaprevir/Pibrentasvir|Coformulated tablet for oral administration
15955389|NCT03222557|Procedure|Electroacupuncture|Refer to arm description
15955390|NCT03222557|Procedure|Sham Acupuncture|Refer to arm description
15955391|NCT03222557|Device|Electroacupuncture|Refer to arm description
15955392|NCT03222557|Device|Sham Acupuncture|Refer to arm description
15955393|NCT03222544|Combination Product|methylene blue|Continue treatment after 5mins suspension if the patient feels that the local temperature is too high to stand
15955394|NCT03222544|Combination Product|Photon therapy instrument|Continue treatment after 5mins suspension if the patient feels that the local temperature is too high to stand
15955395|NCT03222531|Drug|sofosbuvir/velpatasvir|Drug: sofobuvir/velpatasvir
15955396|NCT03222518|Drug|Paracetamol|21 pills of Paracetamol 1000mg are provided with a preconised dose of 1 pill 3 times per day over 7 days period
15955397|NCT03222518|Drug|NSAID|14 pills of piroxicam 20 mg are provided with a preconised dose of 1 pill 2times per day over 7 days period
15955398|NCT03222518|Drug|paracetamol-NSAID|21 identical pills of paracetamol ith a preconised dose of 1 pill 3 times per day over 7 days period+14 pills of piroxicam 20 mg are provided with a preconised dose of 1 pill 2times per day over 7 days period
15955399|NCT03222505|Device|Honda Stride Assist Device ON|Subjects performed assessments of walking and motor performance while wearing the Honda Stride Assist Device.
15955400|NCT03222505|Other|No Device Worn|Subjects performed assessments of walking and motor performance without wearing the Honda Assist Device.
15955401|NCT03222492|Biological|Brentuximab Vedotin|Ascending dose cohorts. All cohorts will receive intravenous administration of study medication every 3 weeks for 21 weeks, for a total of eight doses.
15955402|NCT03222492|Biological|Placebo|Placebo control for blinding (masking), 0.95% normal saline.
15955403|NCT03222479|Behavioral|Stress guide|smartphone-based application that can evaluate stress level and teach how to manage their stress
15955404|NCT03222466|Other|Co-created PEM|A co-created PEM has been designed in collaboration with patients.
15955405|NCT03222453|Biological|Hematopoetic stem cells|Patient will inject with hematopoetic stem cells differentiated from beta-thalassemia induced pluripotent stem cells
15955406|NCT03222440|Drug|SHR-1210|SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.
15955407|NCT03222427|Drug|LY3314814|Administered orally
15955408|NCT03222427|Drug|[13C415N3] LY3314814|Administered as an IV infusion
15955409|NCT03222414|Device|Non-invasive BP recording with conical Ultracheck Curve BP cuff|Non-invasive SBP, DAP and MAP will be measured in both arms using conical Ultracheck Curve BP cuff
15955410|NCT03222414|Device|Non-invasive BP recording with traditional cylindrical BP cuff|Non-invasive SBP, DAP and MAP will be measured in both arms using traditional cylindrical BP cuff
15955411|NCT03222414|Other|Direct invasive arterial pressure|Direct invasive arterial pressure readings will be recorded simultaneously with non-invasive measurements
15955412|NCT03222401|Drug|1 mg/kg single infusion of F598|1 mg/kg single infusion of F598
15955413|NCT03222401|Drug|3 mg/kg single infusion of F598|3 mg/kg single infusion of F598
15955414|NCT03222401|Drug|10 mg/kg single infusion of F598|10 mg/kg single infusion of F598
15955415|NCT03222388|Other|Questionnaire - IIEF 5/15|International Index of Erectile Function
15955416|NCT03222375|Device|SQUED™ series 28.1 home-use|"Semiconducting QUantum Excitonic Device - artifificial active medium, where the processes of self-organization lead to creation and converter of Autowaves energy.
~Some autowaves have the properties of quasi-particles!"
15955417|NCT03222362|Other|Surgery|
15955418|NCT03222349|Drug|Diazepam Buccal Film|Subjects received a single DBF dose determined by age and body weight during the interictal state and during the ictal/peri-ictal period with at least 14 days washout between doses.
15955419|NCT03222336|Behavioral|Family pedigree and data collection|"Enroll first generation (newborn), at least one member from second (parent) and third generation (grandparent) for a complete IVS4 family tree mapping.
~Collect and analyze medical history, genetic and biochemical assessment data"
15955420|NCT03222323|Drug|Dexmedetomidine perineurally|Dexmedetomidine is added perineurally on one side and will influence the nerve block perineurally on this side. Dexmedetomidine is also absorbed and redistributed systemically and will influence the opposite ulnar nerve block systemically.
15955421|NCT03222323|Drug|Ropivacaine 5mg/ml|Ropivacaine is used in 5mg/ml in the perineural, systemic and placebo nerve blocks.
15955422|NCT03222323|Drug|Ropivacaine 7.5mg/ml|In the high dose ropivacaine group a ropivacaine concentration of 7.5mg/ml is used.
15955423|NCT03222323|Drug|Dexmedetomidine systemically|Dexmedetomidine administered perineurally on one side is absorbed and redistributed systemically and will influence the opposite ulnar nerve block systemically.
15955424|NCT03222323|Drug|Isotonic saline|placebo (saline) is administered perineurally in all but the perineural group.
15955425|NCT03222310|Drug|Ipatasertib|Ipatasertib 100 mg tablet orally once daily.
15955426|NCT03222310|Drug|Itraconazole|Itraconazole 100 mg capsules orally once daily.
15955427|NCT03222297|Device|early skull repair|Patients with craniocerebral injury were randomized into test group (n = 40) with early skull repair using titanium mesh within 1-3 months after decompression.
15955428|NCT03222297|Device|late-stage skull repair|Patients with craniocerebral injury were randomized into control group (n = 46) with late-stage skull repair using titanium mesh within 6-12 months after decompression.
15955429|NCT03222284|Device|Cornerstones4Care Powered by Glooko App|Cornerstones4Care Powered by Glooko App is an iOS or Android smartphone application designed to support diabetes management by offering people with diabetes easily accessible, personalized tools for self-monitoring and education. C4C allows people with diabetes to monitor personal health metrics and blood glucose levels, with the aim to achieve participant behavior changes that may contribute to lower hospitalizations, diabetes-related complications and overall healthcare costs.
15955430|NCT03222271|Device|Extubation to NIV|Weaning using NIV immediately after extubation with the mentioned parameters
15955431|NCT03222258|Behavioral|Early palliative care|Palliative Care Team provide a self-learning booklet, medical treatment and consultation about Advance Care Planning with chemotherapy by oncologist.
15955432|NCT03222258|Behavioral|Routine hospice care|Palliative Care Team provide a routine hospice care the same as other patients who doesn't participate this study after the chemotherapy is totally terminated
15955433|NCT03222232|Behavioral|catheter salvage|In each case of catheter-related bloodstream infection the management of the central venous catheter was registred to evaluate the future risk of new infections
15955434|NCT03222219|Procedure|dental implant insertion|the registration of the torque values is discriminant for the group assignment after dental implant insertion
15955435|NCT03222206|Drug|Salsalate|"Medicate salsalate 2g/day after run-in period
~Check side effect after 1 month and Control dosage (2g/day or 3g/day)
~Check side effect after 2 month"
15955436|NCT03222206|Other|Placebo|"Medicate placebo 2g/day after run-in period
~Check side effect after 1 month and Control dosage (2g/day or 3g/day)
~Check side effect after 2 month"
15955437|NCT03222193|Device|TRP|3 months of TRP tongue retraining
15955438|NCT03222180|Behavioral|Website|Participants in the Website condition will be provided with password-protected access to the online resource created for this trial that provides a variety of information, support and guidance that could permit them to adapt more effectively to the demands of parenting a very young child with type 1 diabetes.
15955439|NCT03222167|Drug|Elbasvir/ Grazoprevir 50/100 mg fixed dose combination|Enrolled patients will be treated by Elbasvir/ Grazoprevir 50/100 mg fixed dose combination during 12 week. Followed-up on week 24. SVR12 will be evaluated.
15955440|NCT03222154|Device|Experimental - Shock wave therapy|Shock wave therapy was performed with the Master Plus 200® Storz Medical equipment, radial emission 2000 pulses, frequency 15 Hz and pressure 1 Bar.
15955441|NCT03222154|Device|Placebo - Shock wave therapy|Simulation of shock wave therapy
15955442|NCT03222141|Device|TAVR Implantation of the THV Prosthesis|Patients with TAVR implantation
15955443|NCT03222128|Device|TAVR|Implantation of the SAPIEN 3
15955444|NCT03222102|Device|Phasix mesh|After the closure of the Abdomen, Phasix mesh will be placed and affixed on the exposed fascia.
15955445|NCT03222089|Drug|Irinotecan|Irinotecan 165 mg/m² 1-hour IV day 1
15955446|NCT03222089|Drug|Oxaliplatin|oxaliplatin 85 mg/m² 2-hours IV day 1
15955447|NCT03222089|Drug|Levoleucovorin|Levoleucovorin 200 mg/m² 2-hours IV day 1
15955448|NCT03222089|Drug|5-FU|5-FU 2800 mg/m² 46-hours flat continuous infusion IV
15955449|NCT03222089|Drug|GM-CSF|GM-CSF 150ug s.c. d3-7 , Repeated every 4 weeks.
15955450|NCT03222089|Drug|IL-2|Interleukin-2 100MIU s.c. d8-14 and d17-d28, Repeated every 4 weeks.
15955451|NCT03222076|Biological|Ipilimumab|Given IV
15955452|NCT03222076|Biological|Nivolumab|Given IV
15955453|NCT03222063|Other|Play interventions|The following play were included in play interventions i.e building blocks, paint, puzzles, crayons, doctor set, ludo, snake and ladder. All hospitalized children in experimental group received play interventions at bed side. Taking into consideration the busy clinical setting, each participant received continuously 1 hour of hospital play interventions each day for continuous 5 days. Although the hospitalized children were free to choose according to their choice but still the younger children would be engaged in play such as doctor set, Drawing etc. to obtain more sensory experience and older children were offered play interventions such as puzzle, building blocks, ludo etc.with high cognitive demand.
15955454|NCT03222050|Other|Distraction technique|
15955455|NCT03222037|Device|senofilcon A|Acuvue Oasys 1-Day
15955456|NCT03222037|Device|Control|Trial Frame with best spherocylindrical refraction (SCR)
15955457|NCT03222024|Other|routine medical care|This is an observational study for clinical course and outcomes of severe ischaemic stroke; therefore, interventions are prescribed by responsible doctors based on patients' clinical conditions, which is not interfered by current study
15955458|NCT03222011|Procedure|Standard (single) endoscopic stricture dilatation|single endoscopic stricture dilatation
15955459|NCT03222011|Procedure|Intensive endoscopic stricture dilatation|3 endoscopic dilatations 3 weeks apart and possible needle knife strictureplasty
15955460|NCT03221998|Drug|IV paracetamol|100 gram paracetamol infusion for moderate pain management
15955461|NCT03221998|Drug|IV saline (NaCl 0.9 %)|100 ml of Normal Saline (IV NaCl 0.9 %) as placebo
15955462|NCT03221985|Other|questionnaires|questionnaire with application on smartphone
15955463|NCT03221959|Device|Medical Device Vittamed 205|Intracranial pressure measurement
15955464|NCT03221946|Drug|Diclofenac Sodium|tablet of 50mg,
15955465|NCT03221946|Drug|Diclofenac sodium|Transdermal patch 100 mg
15955466|NCT03221946|Drug|Diclofenac|intra muscular injection 100mg
15955467|NCT03221933|Biological|Somatropin Injection low dose group|0.23mg/kg /wk，inject for seven divided doses
15955468|NCT03221933|Biological|Somatropin Injection high dose group|0.46mg/kg /wk，inject for seven divided dose
15955469|NCT03221920|Other|Very Low Carbohydrate Diet|1 : 4 ratio of carbohydrate to fat of the total daily calories intake
15955471|NCT03221907|Drug|GLA5PR GLARS-NF1 placebo|tablet manufactured to mimic GLA5PR GLARS-NF1
15955472|NCT03221907|Drug|Pregabalin|Pregabalin capsule
15955473|NCT03221907|Drug|Pregabalin placebo|tablet manufactured to mimic pregabalin capsule
15955474|NCT03221894|Dietary Supplement|GRAPE granules|GRAPE granules was mainly consisted of herbal medicines: Ren Shen (Ginseng, 10g/d), Di Huang (Rehmannia glutinosa, 30g/d), Shi Cangpu (Acorus tatarinowii, 10g/d), Yuan Zhi (Polygala tenuifolia, 10g/d), Yin Yanghuo (Epimedium brevicornu, 10g/d), Shan Zhuyu (Cornus officinalis, 10g/d), Rou Congrong (Cistanche deserticola, 10g/d), Yu Jin (Curcuma aromatica, 10g/d), Dan Shen (Salvia miltiorrhiza, 10g/d), Tian Ma (Angelica sinensis, 10g/d), Tian ma (Gastrodia elata, 10g/d), and Huang Lian (Berberine, 10g/d), which were supplied by Beijing Tcmages Pharmaceutical Co., LTD, Each bag of granules with 150ml warm water melt was taken orally twice a day.
15955475|NCT03221881|Drug|Pegylated Liposomal Doxorubicin and docetaxel|
15955476|NCT03221868|Behavioral|Exercise group|An exercise-based program following a 12-week periodization using mostly circuit-like activities.
15955477|NCT03221868|Behavioral|Control group|Counseling to practice physical activity and meetings every 15 days with women to conduct group walks. Booklet with walking schedule and for registering sessions.
15955478|NCT03221855|Drug|Domperidone|Capsules 10mg orally each 8 hours for 7 days.
15955479|NCT03221855|Drug|Placebo|Capsules 10mg orally each 8 hours for 7 days.
15955480|NCT03221842|Drug|C1-esterase inhibitor|C1-esterase inhibitor is a human plasma-derived lyophilised powder for reconstitution
15955481|NCT03221842|Drug|Placebo|Excipients of C1-INH plus albumin
15955482|NCT03221816|Drug|Tenavit®|The experimental group received one tablet of Tenavit® daily for a period of 4 months.
15955483|NCT03221816|Drug|Placebo Oral Tablet|Placebo group received the same tablet with the organoleptic characteristics of Tenavit® for a period of 4 months.
15955484|NCT03221803|Other|OT Vertical attachment|new extra coronal castable attachment
15955485|NCT03221803|Other|OT cap attachment|standard extra coronal attachment
15955486|NCT03221790|Other|Low FODMAP Diet followed by a High FODMAP Diet|3 weeks on a low FODMAP diet followed by 3 weeks on a high FODMAP Diet
15955487|NCT03221777|Diagnostic Test|14 Day ECG Patch (Zio XT Patch, iRhythm Technologies)|The ZIO XT Patch (http://www.irhythmtech.com/zio-solution/zio-patch/) is an ultra-portable wearable adhesive patch monitor that provides continuous single-lead ECG recording for up to 14 days. It has been cleared by the FDA for arrhythmia detection and is in current clinical use in the U.S.[87]. It will be used in this study under an investigational testing authorization by Health Canada. The ZIO XT Patch is a single-use device worn over the left pectoral region with a skin adhesive (Figure 4). Its small, lightweight, water-resistant, patch-based design has advantages for patients compared with traditional ECG screening methods (e.g. Holter, event loop recorders, mobile outpatient telemetry systems), which are all more cumbersome and require detachable wired leads, two or more removable skin contact electrodes, plus separate recording units (+/- smartphone attachment).
15955488|NCT03221764|Drug|Amiodarone with CoSeal|CoSeal Surgical Sealant (Baxter Healthcare) consist of 2 formulations of synthetic polyethylene glycols, a dilute hydrogen chloride solution along with a sodium phosphate/sodium carbonate solution. These separate solutions are mixed at the time of application to form a hydrogel. Amiodarone hydrochloride powder (1mg/kg) will be mixed with CoSeal at the time of application to form an amiodarone containing hydrogel. The dosing of amiodarone is based on previous study using amiodarone hydrogel in post-operative coronary artery bypass patients [8]. This hydrogel will be delivered utilizing a CO2 driver along the pulmonary vein and arterial anastomoses, and to the surface right and left atria.
15955489|NCT03221764|Device|CO2 driver|The amiodarone hydrogel will be delivered utilizing a CO2 driver along the pulmonary vein and arterial anastomoses, and to the surface right and left atria.
15955490|NCT03221751|Drug|prazosin hydrochloride|Prazosin is an oral capsule identical in appearance to prazosin capsules titrated in the same manner as prazosin.
15955491|NCT03221751|Drug|placebo|Prazosin is an oral capsule identical in appearance to prazosin capsules titrated in the same manner as prazosin.
15955492|NCT03221738|Behavioral|App-Based Cognitive Behavioral Therapy|12-week Smartphone delivered CBT for BDD. In-person cognitive behavioral therapy (CBT) is an empirically supported treatment for BDD. The app-delivered CBT in this project includes modules such as cognitive skills (e.g., cognitive restructuring, core belief work), behavioral skills (e.g., exposure with ritual prevention), and perceptual retraining/mindfulness skills.
15955493|NCT03221725|Procedure|sacrospinous ligament fixation|sacrospinous ligament fixation will be applied to prevent vaginal vault prolapse
15955494|NCT03221712|Behavioral|cardiac rehabilitation|cardiac rehabilitation in patients with chronic total occlusion of the coronary arteries.
15955495|NCT03221699|Other|Formula with ZnO|Forearms and axillae are treated by the volunteers once daily with a standardized amount of the roll-on with ZnO
15955496|NCT03221699|Other|Formula without ZnO|Forearms and axillae are treated by the volunteers once daily with a standardized amount of the roll-on without ZnO
15955497|NCT03221686|Dietary Supplement|Intervention|The patients in the intervention group are given 55 mg zinc, 1251 mg vitamin C, and 15 g arginine once daily 14 days pre-operatively and post-operatively together with a high quality protein supplement.
15955498|NCT03221686|Dietary Supplement|Control|High quality protein supplement 14 days pre-operatively and post-operatively.
15955499|NCT03221660|Device|F-Composite 2 system|Procedures will be done using local anesthesia (if the patients wants that). The cavity is prepared according to the principles of the adhesive technique. First the adhesive will be applied and polymerized, afterwards the flowable resin-based restorative material will be applied and polymerized and then the sculptable resin-based restorative material will be applied and polymerized; all materials will be light-cured within short time with an experimental curing light.
15955500|NCT03221647|Other|Intestinal biopsies|Intestinal biopsies obtained from Patients and Controls by EGDS. The patients and controls had the intestinal biopsies as a diagnostic step or routine check independently from the present study. For this study 3 additional biopsies samples were done in patients and controls that signed the informed consent.
15955501|NCT03221634|Biological|Pembrolizumab|IV infusion
15955502|NCT03221634|Biological|Daratumumab|IV infusion
15955571|NCT03221179|Biological|RO7049665|A single ascending dose (starting dose 1.5 micrograms [mcg])of RO7049665 will be administered SC.
15955572|NCT03221179|Biological|Placebo|Matching placebo will be administered SC once.
15955503|NCT03221621|Procedure|Wide Excision|Wide excision is performed under general anaesthesia or procedural sedation and analgesia (PSA). All lesional tissue, including fibrosis, is electrosurgically removed until the area is clear. The subcutaneous fat and epithelised sinus floors are left intact where possible. The wounds are left open to heal by secondary intention.
15955504|NCT03221621|Drug|Adalimumab Injection|Adalimumab will be administered through subcutaneous injections in weekly dose of 40mg from week 4 up to 24 months (V8), after an initial dose of 160mg at week 0 and a 80mg dose at week 2 until end of study or last surgery.
15955505|NCT03221608|Procedure|Surgery and HIPEC with Lobaplatin|The combination of surgery and HIPEC with Lobaplatin are performed in patients with colorectal cancer (T4N0-2M0).
15955506|NCT03221608|Procedure|Surgery without HIPEC|The patients with colorectal cancer (T4N0-2M0) are undergone a curative resection by laparoscopy or open approach.
15955507|NCT03221595|Device|Operative|This operation involves reducing and providing rigid fixation of displaced rib fractures with permanent plates or splints
15955508|NCT03221582|Drug|EBR/GZR|Elbasvir and Grazoprevir (EBR/GZR) tablet by mouth, once daily.
15955509|NCT03221569|Drug|Intravenous ketamine|0.3mg/kg IVPB over 15 minutes
15955510|NCT03221569|Drug|Ketorolac|as active comparator, will be administered together with metoclopramide in one normal saline 50ml bag
15955511|NCT03221569|Drug|Normal saline|"Will be given as 50ml intravenous bag as placebo for double-blinding purposes in patients who will also receive intranasal ketamine.
~Will be prepared in intranasal syringe for double blinding purposes for patients who are randomized to receive intranasal ketamine."
15955512|NCT03221569|Drug|Normal saline|1ml intravenous push as placebo for double-blinding purposes
15955513|NCT03221556|Behavioral|Engagement-Focused Care Coordination|Engagement interviewing is embedded within a traditional PCMH structure using motivational interviewing and shared decision making; it explores treatment options in the context of a patient's life circumstances, and helps her work through ambivalence to receiving care. In one to two sessions, providers disclose the probable diagnosis of depression, provide psycho-education, present treatment options, and engage clients in shared decision making to determine the most appropriate referral.
15955514|NCT03221556|Behavioral|Problem Solving Education (PSE)|Problem solving sessions are one-on-one, workbook-based interactions. Sessions comprise seven sequential steps: 1-defining a problem, 2-establishing goals for problem resolution, 3-generating multiple solution alternatives, 4-Implementing decision making guidelines, 5-evaluating and choosing solutions, 6-Implementing the preferred solutions, and 7-evaluating the outcome.
15955515|NCT03221543|Device|ReeVue Indirect Calorimeter|The ReeVue Indirect Calorimeter will be used in this study to measure the resting metabolic rate. The test takes approximately ten minutes to complete. The subject should prepare for the test by avoiding stimulants and exercise on the day of the test, as well as eating meals four hours before the test. The subject will be seated during the test. They will be given a nose clip that looks like a clothes pin to be placed on their nose. A plastic mouth piece that allows all of the air they breathe to come in through the top of the mouth piece and the air they breathe out to go into the ReeVue Calorimeter will also be provided. The subject will remain in this position for ten minutes until the testing is complete.
15955516|NCT03221530|Behavioral|Early Intervention for Suicide Risk Among Immigrant Youth|The EISR-I intervention includes family treatment engagement, shared problem definition, and sessions designed to address family cohesion, communication, and conflict resolution.
15955517|NCT03221530|Behavioral|Enhanced usual care|This intervention includes a session with the family to engage in safety planning and provide feedback on their baseline assessment data.
15955518|NCT03221517|Other|Standardized meal with a glucose challenge test|Postprandial glucose and insulin response
15955519|NCT03221504|Other|Longer therapy duration|Patients will receive cefuroxime axetil orally. Treatment will involve the supply of cefuroxime axetil 30 mg/kg/d in two divided doses (in blinded bottles).
15955520|NCT03221504|Other|Shorter therapy duration|Patients will receive placebo orally (in blinded bottles). The volume of the placebo will be like cefuroxime syrup.
15955521|NCT03221491|Device|Patient-Controlled Analgesia(PCA)|Patients receive analgesic regimens using Patient-Controlled Analgesia(PCA) with different background infusion.
15955522|NCT03221478|Other|Kinesio Taping placebo and exercises|Kinesio Taping placebo and exercises
15955523|NCT03221478|Other|Kinesio Taping with tension and exercises|Kinesio Taping with tension and exercises
15955524|NCT03221478|Other|Kinesio Taping with tension|Kinesio Taping with tension
15955525|NCT03221465|Behavioral|Self-monitoring of physical activity with incentives|Participants are given a pedometer (e.g. Misfit brand wrist pedometer) to allow self-monitoring of physical activity and receive financial incentives. Participants also answer two health questions a week for 12 weeks.
15955526|NCT03221465|Behavioral|Usual care and self-monitoring of physical activity|Participants simply given a pedometer (e.g. Misfit brand wrist pedometer) with no other intervention to allow self-monitoring of physical activity.
15955527|NCT03221452|Behavioral|Memory, Attention, and Problem Solving Skills for Diabetes|Classes will include: (1) information on diabetes self-management including glucose self-monitoring and medication management; (2) assessment of cognitive problems; (3) resources and barriers to self-management; and (4) lifestyle changes to maximize cognitive health. Participants will also practice those skills with online computer games.
15955528|NCT03221439|Behavioral|Cognitive Functional Therapy|"There will be four main components in the intervention, following the protocol used by O'Keefe et al. (2015):
~The cognitive component will focus on on the multidimensional nature of persistent pain about individual beliefs, and how emotions and behaviors (movement and lifestyle) can reinforce a vicious cycle of pain and disability.
~Specific Functional training is designed to normalize maladaptive or provocative movement and posture.
~Functional integration directed to activities of daily life that are avoided by the patient (rolling in bed, sitting, sitting to standing, walking, bending and lifting)
~Patients will be advised to gradually increase physical activity based on their preference, also focusing on sleep hygiene, stress, and management strategies"
15955573|NCT03221166|Drug|Thalidomide|Thalidomide is a immunomodulatory and antiangiogenetic drug with anti TNF alpha properties
15955574|NCT03221166|Drug|Infliximab|Infliximab is a chimeric monoclonal antibody against TNF alpha
15955575|NCT03221153|Procedure|Simulation techique|The intervention group will be in a simulated case with mock scenarios and interaction by 'acting out' the clinical situation where knowledge and attitudes about safety in hospitalized patients will be assessed.
15955529|NCT03221439|Other|Manual Therapy and Motor Control Exercise|According to the pragmatic clinical decision of the physiotherapist responsible for this intervention arm, participants allocated to the comparison group will be treated with joint mobilization or manipulation techniques applied to the lower back or pelvis. The active exercises will involve isolated contractions of the deep abdominal and multifidus muscles in different functional positions. Most patients in this group will receive exercises to perform at home. This will include general exercise or motor control exercise, but not related to CFT.
15955530|NCT03221426|Biological|Pembrolizumab|IV infusion
15955531|NCT03221426|Drug|Placebo|IV infusion
15955532|NCT03221426|Drug|Cisplatin|IV infusion
15955533|NCT03221426|Drug|Capecitabine|Oral tablets
15955534|NCT03221426|Drug|5-fluorouracil|IV infusion
15955535|NCT03221426|Drug|Docetaxel|IV infusion
15955536|NCT03221426|Drug|Oxaliplatin|IV infusion
15955537|NCT03221426|Drug|Leucovorin|IV infusion
15955538|NCT03221413|Device|transcranial alternating current stimulation (tACS)|
15955539|NCT03221400|Drug|PEN-866 Sodium|PEN-866 Sodium is a miniaturized conjugate that comprises an HSP90 targeting ligand linked to SN-38, the active metabolite of irinotecan. PEN-866 is available as a sterile lyophilized powder for solution for infusion.
15955540|NCT03221400|Drug|fluorouracil|Fluorouracil 2400 mg/m2 IV
15955541|NCT03221400|Drug|Folinic acid|Folinic acid 400 mg/m2 IV
15955542|NCT03221400|Drug|Niraparib|Niraparib
15955543|NCT03221387|Device|Humidified nasal high flow with oxygen|The AIRVO 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases.
15955544|NCT03221374|Behavioral|Mindfulness Based Stress Reduction|8-week mindfulness based stress reduction course intended to develop mind-body awareness through mindfulness practices.
15955545|NCT03221361|Device|thermoplastic complete denture|a device used ti substitute teeth for edentlous patient made of thermoplastic resin
15955546|NCT03221361|Device|conventional acrylic resin complete denture|A device used to substitute the teeth for edentlous patient made of acrylic resin
15955547|NCT03221348|Biological|CHO-H01|Glyco-engineered anti-CD20 antibody
15955548|NCT03221335|Device|EUS-guided RFA|All patients would undergo EUS with a linear array echoendoscope. The location and size of the lesion would be assessed for suitability of treatment. After locating the lesion, the RFA needle would be inserted to the centre of the lesion. RFA would then be initiated and hyperechoic interferences would be observed around the electrode signifying heating of the tissue. The duration of ablation would be according to the size of the lesion.
15955549|NCT03221322|Behavioral|Superlean|Behavioural data will be collected on all subjects in either control group or superlean group. Blood or saliva samples will be collected for DNA extraction and genotyping.
15955550|NCT03221309|Other|Evaluate model of care for HCV-infected adults with on-going opioid misuse|Participants will be treated with direct-acting antivirals per standard of care and will be concomittantly be offered PreP for HIV prevention and buprenorphine for treatment of opioid-use disorder when clinically indicated
15955551|NCT03221296|Behavioral|Vestibular Training (Intervention Group)|Exercises three times daily, for up to approximately 20 minutes. Changes in functional status and physical status shall be measured at study onset and follow up.
15955552|NCT03221283|Behavioral|Music therapy group|The experimental group received 13 group music sessions over a three-month period. Different method of music therapy will be used to improve the emotion experience, emotion regulation, emotional control and emotional expression.
15955553|NCT03221270|Device|tACS (alpha)|Neuroconn DC Stimulator
15955554|NCT03221270|Device|Sham tACS (alpha)|Neuroconn DC Stimulator
15955555|NCT03221257|Drug|Pirfenidone (PFD)|Participants will receive PFD titrated up to a target dose of 801 mg taken three times daily as tolerated (3-step titration occurring at 2 week intervals).
15955556|NCT03221257|Drug|Placebo (Plac)|Participants will receive a Plac, matched to resemble PFD, titrated up to a target dose of 801 mg taken three times daily as tolerated (3-step titration occurring at 2 week intervals).
15955557|NCT03221257|Drug|Mycophenolate Mofetil (MMF)|Participants will receive MMF titrated up to a target dose of 1500 mg taken twice daily as tolerated (4-step titration occurring at monthly intervals).
15955558|NCT03221244|Device|VR Treatment|Distractors
15955559|NCT03221244|Device|VR Active Control|No distractors
15955560|NCT03221231|Drug|N-acetylcysteine|1200 mg/day, twice daily, N-acetylcysteine
15955561|NCT03221231|Drug|Placebo Oral Tablet|twice daily, placebo
15955562|NCT03221231|Other|Magnetic Resonance Imaging|
15955563|NCT03221231|Other|Neurocognitive measures|
15955564|NCT03221231|Other|Neuro-inflammatory measures|
15955565|NCT03221218|Other|Enhanced screening-informed follow up letter|Family Physicians will be sent a letter that includes their screening test results and associated symptom-specific recommendations from the Ontario Neurotrauma Foundation clinical practice guidelines.
15955566|NCT03221205|Device|Sham CPAP|CPAP (ResMed AutoSet S9 with humidifier) to be used by the participant via nasal mask and tube, programmed to apply 0.5 cmH2O (measured at the nasal mask) via a resistance to assure the lack of distal pressure.
15955567|NCT03221205|Device|Therapeutic CPAP|Use of CPAP (ResMed AutoSet S9 with humidifier) through nasal mask and tube with automatized pressure from 4 to 20 cmH2O.
15955568|NCT03221192|Other|VAS questionnaire|VAS questionnaire is a PRO tool in which subjects will be asked to evaluate overall symptom severity, or the severity of individual symptoms of nasal polyps along a continuum, typically of 10 centimeter (cm) or 100 millimeter (mm) whereby 0 represents 'no symptom' and '10 or 100 represents 'as bad as you can imagine', Scores of 0-3 (or 0-30) are defined as mild disease, >3-7 (or >30-70) as moderate disease and >7-10 (or >70-100) as severe disease.
15955569|NCT03221192|Other|SNOT-22 questionnaire|SNOT-22 is a PRO tool to measure HRQoL associated with rhinosinusitis with or without nasal polyps. It contains 22 nose, sinus, and general HRQoL items and subjects will be required to score the experience on a 6-point scale ranging from 0 (no problem) to 5 (Problem as bad as it can be) and identify the five most important items affecting their health.
15955570|NCT03221192|Other|Data capture app|Real time data capture app is a smart-phone or web-based application which will allow the subjects to communicate about their experience of nasal polyps in real-time as they go about their daily lives via varying video, audio, photographic and text responses.
15955576|NCT03221140|Drug|Outpatient parenteral antimicrobial therapy|Administration of intravenous antimicrobials on an outpatient basis
15955577|NCT03221114|Behavioral|Positive Psychological Intervention|Our culturally-tailored Positive Psychology Intervention is a non-pharmacotherapy approach aimed at increasing positive emotional experiences by teaching individuals to engage in intentional activities known to increase psychological and emotional well-being through targeting of constructs such as optimism, gratitude, mindfulness/relaxation, and resilience.
15955578|NCT03221101|Device|Home ventilator|
15955579|NCT03221088|Drug|Jintrolong® low dose group|PEG-somatropin 0.1mg/kg/wk by weekly subcutaneous injection for 52 weeks.
15955580|NCT03221088|Drug|Jintrolong® high dose group|PEG-somatropin 0.2 mg/kg/wk by weekly subcutaneous injection for 52 weeks.
15955581|NCT03221075|Other|Registry|There is no intervention.
15955582|NCT03221062|Device|Laser en Bloc Resection|Procedure: Laser en Bloc Resection of bladder tumor Procedure: Hydroknife transurethral resection of bladder tumor Procedure: conventional transurethral resection
15955583|NCT03221049|Diagnostic Test|radiomics|
15955584|NCT03221036|Drug|Vedolizumab IV|Vedolizumab IV infusion
15955585|NCT03221036|Drug|Placebo|Matching-placebo IV infusion
15955586|NCT03221023|Drug|Vancomycin Hydrochloride|Individuals in the experimental arm will receive intrawound Vancomycin-saline + IV antibiotics
15955587|NCT03221023|Drug|Saline Solution|Individuals in the control arm will receive intrawound saline solution
15955588|NCT03221010|Behavioral|Motivational Interviewing|Motivational Interview (MI) is a person-centered, communicative method whose purpose is to work and increase the user's motivation for behavior change.
15955589|NCT03221010|Behavioral|Traditional cognitive-behavioral approach|This approach aims to combine cognitive interventions in the training of behavioral skills in patients, developing strategies to cope with the problem and detecting situations of risk, mobilizing the subject for his own process of change. Helps correct cognitive dysfunctions and behavioral changes in specific situations.
15955590|NCT03220997|Dietary Supplement|Vitaflow Preload|Carbohydrate loading drink
15955591|NCT03220984|Biological|Immuncell-LC intravenous infusion using a CIK cell agent|Patients with metastatic colorectal cancer, which is refractory to the 3rd-line chemotherapy are enrolled in this study. Enrolled patients receive a total of 12 times of Immuncell-LC therapy: 8 times in every 1 week and the next 4 times in every 2 weeks. The treatment responses of immuncell-LC are evaluated by radiologic findings (Abdomin-pelvic CT and Chest CT), immune-markers and a selorogic tumor marker (Carcinoembryologic antigen (CEA)) at the 8th week and 17th week. The safety of Immuncell-LC is evaluated by the results of serologic tests, vital signs, ECOG-PS and adverse events. The follow-up period is the 1 year after the enrolled date.
15955592|NCT03220971|Other|lipoprotein and apolipoproteins|To find out the role of lipoprotein and apolipoproteins (apos) in pathogenic hepatic diseases
15955593|NCT03220958|Drug|Metoclopramide|Metoclopramide 20mg
15955594|NCT03220958|Drug|Diphenhydramine|Diphenhydramine 25mg
15955595|NCT03220958|Drug|Normal saline|100ml normal saline
15955596|NCT03220945|Other|Yoga|Receive yoga instruction
15955597|NCT03220932|Procedure|Cytoreductive surgery combined with HIPEC|Cytoreductive surgery combined with HIPEC (Cisplatin 70 mg/m2).
15955598|NCT03220932|Drug|Chemotherapy and bevacizumab (CT-BEV)|Chemotherapy and bevacizumab (CT-BEV) 15 mg/kg once every 3 weeks from enrollment until disease progression (RECIST 1.1)
15955599|NCT03220919|Other|Weight-based|Glargine titration: 0.1U/kg per day when FBG is over 8.0 mmol/L. Aspart titration: total dose 0.1U/kg per day when next pre-meal BG is over 8.0 mmol/L, which is divided into three equal parts adding to three pre-meal boluses
15955600|NCT03220919|Other|Glucose level-based|"Glargine titration: 4, 6, or 8 U when FBG is, respectively, within the following ranges: 8.0-8.9, 9.0-9.9, >10.0 mmol/L.
~Aspart titration: 1, 3, 5, 7 or 8 U when next pre-meal BG is, respectively, within the following ranges: 8.0-10.9, 11.0-13.9, 14.0-16.9, 17.0-19.9, > 20 mmol/L."
15955601|NCT03220906|Other|Blood pressure measurement|Blood pressure will be measured in both upper and lower extremities.
15955602|NCT03220893|Diagnostic Test|Molecular Breast Imaging|Molecular breast imaging (MBI) is a new nuclear medicine technique that utilizes small semiconductor-based γ-cameras in a mammographic configuration to provide high-resolution functional images of the breast.
15955603|NCT03220893|Diagnostic Test|Digital Breast Tomosynthesis|Digital Breast Tomosynthesis (DBT) creates a three dimensional picture of the breast using X-rays.
15955604|NCT03220880|Drug|Intranasal dexmedetomidine|Intranasal dexemedetomidine (100 mcg/mL), 0.5 to 4 mcg/kg
15955605|NCT03220867|Drug|Risperidone: Xian Risperdal (test)|Participants will receive 1*1 mg tablet of Xian Risperdal under fasting or fed condition.
15955606|NCT03220867|Drug|Risperidone: Gurabo Risperdal (reference)|Participants will receive 1*1 mg tablet of Gurabo Risperdal under fasting or fed condition.
15955610|NCT03220841|Drug|Adalimumab Injection|Standard dose adalimumab induction and maintenance
15955611|NCT03220841|Drug|Thiopurine|Dose optimized thiopurine
15955612|NCT03220841|Procedure|Endoscopic balloon dilatation|Prior to randomization, suitable patients may undergo endoscopic balloon dilatation. Patients undergoing dilatation will be stratified to ensure equal numbers in each study arm.
15955613|NCT03220828|Behavioral|Technology Based Distractions|Technology based distractions (VR headsets)
15955614|NCT03220815|Procedure|Drilling at low speed|
15955615|NCT03220815|Procedure|Conventional drilling at high speed|
15955661|NCT03220490|Behavioral|no interval between regular glaucoma drops - Long term|In the selected eye, the patient will be asked to take his two regular IOP reduction drugs one after the other with no waiting period for a duration of one month.
15955700|NCT03220243|Drug|MSC-AFP|Eligible patients will be treated with a fistula plug that has been coated with autologous mesenchymal stromal cells.
15955616|NCT03220802|Dietary Supplement|OMNI-BiOTiC PPI|The study product consists of a sachet containing 4g of yellowish powder made of corn starch, maltodextrin, fructo-oligosaccharide P6, inulin P2, vegetable protein and 12 bacterial strains (Bacillus coagulans W183, Bacillus subtilus W201, Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Bifidobacterium lactis W51, Lactobacillus acidophilus W37, Lactobacillus acidophilus W22, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19, Propionibacterium freudenreichii W200, Lactobacillus rhamnosus W71, in a concentration of 2 x 109 cfu/g).
15955617|NCT03220789|Procedure|Drilling at low speed|
15955618|NCT03220789|Procedure|Drilling at conventional or high speed|
15955619|NCT03220776|Drug|N-Acetylcysteine|5 day trial of N-acetylcysteine with titration to 2,400mg
15955620|NCT03220776|Drug|Gabapentin|5 day trial of gabapentin with titration to 1,200mg
15955621|NCT03220776|Drug|Placebo Oral Tablet|5 day trial of matched placebo
15955622|NCT03220763|Other|This is an observational study--there is no intervention.|This is an observational study, there is no intervention.
15955623|NCT03220737|Biological|VAXCHORA (Cholera Vaccine, Live, Oral)|VAXCHORA (Cholera Vaccine, Live, Oral) is a live, attenuated bacterial vaccine suspension for oral administration containing the V. cholerae strain CVD 103-HgR.
15955624|NCT03220737|Other|Placebo|Placebo control for this study is normal (0.9%) saline.
15955625|NCT03220724|Biological|CH505TF|Administered by intramuscular (IM) injection in the thigh
15955626|NCT03220724|Biological|CH505w53|Administered by IM injection in the thigh
15955627|NCT03220724|Biological|CH505w78|Administered by IM injection in the thigh
15955628|NCT03220724|Biological|CH505 M5|Administered by IM injection in the thigh
15955629|NCT03220724|Biological|GLA-SE adjuvant|Admixed with all CH505 gp120 proteins
15955630|NCT03220724|Biological|Placebo|Administered by IM injection in the thigh
15955631|NCT03220711|Device|confocal endomicroscope|"This instrument provides real-time endoscopic histology to guide endoscopic biopsy or endoscopic mucosal resection (EMR) in the patient study group during colonoscopies."
15955632|NCT03220711|Drug|Fluorescein|Fluorescent dye used for imaging contrast only.
15955633|NCT03220698|Device|Tracheal ultrasonography|Tracheal ultrasonography
15955634|NCT03220685|Biological|Stool analysis|Bacterial extraction in faeces by repeated fractional centrifugation to obtain bacterial mass and DNA sequencing.
15955635|NCT03220672|Behavioral|Tailored assessment and educational|Intervention will consist of 45 minutes of anatomy education, pelvic floor assessment and neuromuscular re-education. Women will be given an explanation of how the pelvis is composed, including the viscera and pelvic floor function and anatomy, through a simple explanatory sheet. They will be also informed of the causes of pelvic floor deterioration as well as its consequences.. Neuromuscular re-education will continued by teaching them how to perform slow contractions, fast contractions and lifting contraction. They will be also shown vaginal cones and advised on possible treatment methods if they were needed. After that, women will be given a tip sheet to improve pelvic floor function. Those recommendations will included: Tips to take into account during habits like urination, doing sport, gymnastics or any efforts, pelvic floor muscles exercises and how to use vaginal cones adequately.
15955636|NCT03220659|Device|Multi-point pacing|Pacing from more than one pole from the left ventricular lead
15955637|NCT03220659|Device|Standard settings|Normal bipolar LV pacing
15955638|NCT03220646|Drug|abemaciclib|abemaciclib 200mg PO q12 hours (+/- 2 hours) on days 1-28 of each 28 day cycle.
15955639|NCT03220646|Drug|abemaciclib|200mg PO q12 hours (+/- 2 hours) for 4-7 days prior to surgery. Upon recovery from surgery, patients will resume abemaciclib at the same dose and schedule as cohorts A and C.
15955640|NCT03220633|Drug|ATB-346|
15955641|NCT03220633|Drug|Placebo|
15955642|NCT03220620|Other|GDT|individualized fluid therapy
15955643|NCT03220607|Other|uterocervical angle|uterocervical angle is the angle between lower segment of uterus and cervix
15955644|NCT03220594|Procedure|hypogastric artery ligation|hypogastric artery ligation is the ligation of the internal iliac artery to stop bleeding related to obstetrics obstetric hemorrhage Hysterectomy is the removal of the uterus if bleeding can't stop by hypogastric artery ligation
15955645|NCT03220581|Behavioral|Referral for care|referral for addictions support
15955646|NCT03220581|Behavioral|Behavioral therapy|therapy focused on monitoring gaming behavior and replacing it with other activities and communication skills
15955647|NCT03220568|Other|Fatty acids present in adipose tissue samples|
15955648|NCT03220555|Device|Buzzy® device|Just before the vaccination or venipuncture the device will be applied on the selected site during 30 seconds and then it will be moved 5 cm above the selected site to make the injection or the puncture. The child will choose if he wants to use the cooling system.
15955649|NCT03220555|Drug|EMLAPATCH (lidocaine, prilocaine)|The patch will be applied during 1 hour to 1 hour and half before the vaccination or venipuncture, on the selected site. After 1 hour to 1 hour and half, it will be removed and the injection or the puncture will be made on the selected site.
15955650|NCT03220542|Drug|Probiotics|Saccharomyces boulardii
15955651|NCT03220542|Dietary Supplement|Broccoli|Broccoli sprouts extract
15955652|NCT03220542|Drug|Esomeprazole|Esomeprazole
15955653|NCT03220542|Drug|Amoxicillin|Amoxicillin
15955654|NCT03220542|Drug|Clarithromycin|Clarithromycin
15955655|NCT03220529|Device|Brillouin Ocular Scanner|
15955656|NCT03220516|Procedure|single use digital ureteroscope|All participants in this arm will undergo RIRS using a single use digital ureteroscope.
15955657|NCT03220516|Procedure|reusable fiberoptic ureteroscope|All participants under this arm will undergo RIRS using a reusable fiberoptic ureteroscope
15955658|NCT03220516|Procedure|reusable digital flexible ureteroscope|All participants under this arm will undergo RIRS using reusable digital flexible ureteroscope
15955659|NCT03220503|Procedure|endometrial injury|single induced injury will be done on the posterior endometrium on day 7 of the transfer cycle by using modified Cook catheter.
15955660|NCT03220490|Behavioral|5 minute interval between regular glaucoma drops - Long term|In the selected eye, the patient will be asked to take his two regular IOP reduction drugs while keeping a five minute time interval between instillation of the first and second drug for a duration of one month.
15955701|NCT03220217|Drug|Satoreotide trizoxetan 5-20μg|Positron emission tomography (PET) imaging agent
15955662|NCT03220490|Drug|IOP reduction of Brimonidine and Timolol with time interval|"In the selected eye the subject will be given two types of IOP reduction drops: first Brimonidine, Alphagan® (an alpha-agonist) followed by Timolol, Tiloptic® (a beta-blocker). The drops will be given with a time interval of five minutes between the first and second drop."
15955663|NCT03220490|Drug|IOP reduction of Brimonidine and Timolol no time interval|"In the selected eye the subject will be given two types of IOP reduction drops:first Brimonidine, Alphagan® (an alpha-agonist) followed by Timolol, Tiloptic® (a beta-blocker). The drops will be given one after the other with no waiting period."
15955664|NCT03220477|Drug|Pembrolizumab|Pembrolizumab will be administered at 200mg IV on day 1 of each 21 day cycle.
15955665|NCT03220477|Drug|Guadecitabine|Guadecitabine will be administered subcutaneously given daily on days 1-5 of each cycle with escalating doses by cohort.
15955666|NCT03220477|Drug|Mocetinostat|Mocetinostat will be administered orally with escalating doses on days 8, 10, 13, 15, 17 and 20 of each cycle with escalating doses by cohort.
15955667|NCT03220464|Radiation|Ultra low dose chest computed tomography (ULDCT)|Participants in the study will receive ULDCT at enrollment, after 3-month visit, and after 12-month visit.
15955668|NCT03220464|Radiation|Chest X-ray|Participants in the study will receive chest x-ray at enrollment, after 3-month visit, and after 12-month visit.
15955669|NCT03220464|Diagnostic Test|Interferon-gamma Release Assay (IGRA)|Participants in the study will receive IGRA test at enrollment, after 3-month visit, and after 12-month visit. About 11mL of blood will be drawn from the participants for test of T-SPOT®.TB test and QuantiFERON test.
15955670|NCT03220451|Procedure|Adhesive elastic taping|Adhesive elastic taping placed around a pressure ulcer, according to a planned placement technique
15955671|NCT03220438|Device|Transcranial Magnetic Stimulation|Transcranial Magnetic Stimulation
15955672|NCT03220425|Drug|Insulin detemir|
15955673|NCT03220425|Drug|NPH insulin|
15955674|NCT03220412|Behavioral|Movies with Guns|Participants in this arm viewed movies (National Treasure, The Rocketeer) without guns. The movies, rated PG, were edited to remove guns from the scenes
15955675|NCT03220399|Drug|NVP-1603-1 (P)|1capsule, single oral dosing
15955676|NCT03220399|Drug|NVP-1603-2 (T)|1tablet, single oral dosing
15955677|NCT03220399|Drug|NVP-1603-1 and NVP-1603-2 (P+T)|1capsule and 1tablet co-administration, oral single dosing
15955678|NCT03220386|Other|Decolonization by nasal Octinidin treatment and skin washings|Patients receive nasal Octinidin treatment and skin washings for five consecutive days
15955679|NCT03220360|Procedure|indirect pulp capping|Sixty children with deep caries of deciduous teeth underwent indirect pulp capping and they were selected and randomized into four groups according to pulp capping agents: MTA group, calcium hydroxide group, Biodentine group and TheraCal group.
15955680|NCT03220360|Procedure|direct pulp capping|Sixty children with deep caries of deciduous teeth underwent direct pulp capping and they were selected and randomized into four groups according to pulp capping agents: MTA group, calcium hydroxide group, Biodentine group and TheraCal group.
15955681|NCT03220360|Procedure|vital pulpotomy|Forty-five children with deep caries of deciduous teeth underwent vital pulpotomy and they were selected and randomized into four groups according to pulp capping agents: MTA group, calcium hydroxide group, Biodentine group and TheraCal group.
15955682|NCT03220347|Drug|CC-90010|CC-90010 is an oral, potent and reversible inhibitor of the epigenetic target bromodomain and extra-terminal (BET) proteins.
15955683|NCT03220334|Drug|Platelet rich plasma|The experimental group was treated with PRP for artificial gastric ulcer after ESD.
15955684|NCT03220334|Drug|Normal saline|The control group was treated with normal saline for artificial gastric ulcer after ESD.
15955685|NCT03220321|Other|PICN (VITA Enamic) hybrid abutment crown|Hybrid ceramic
15955686|NCT03220321|Other|Lithium disilicate (IPS e.max) hybrid abutment crown|Glass ceramic
15955687|NCT03220308|Other|MYmind mindfulness training|The MYmind mindfulness training uses a standardised protocol based on mindfulness-based cognitive therapy. It consists of 8 weekly group sessions of 90 minutes for youth with ADHD, and parallel mindful parenting training for the parents. Eight weeks after the last session there is a single 90 minutes booster session.
15955688|NCT03220308|Other|Care-as-usual for children (8-16 years old) with ADHD|According to the Dutch Multidisciplinary guidelines for the diagnosis and treatment of ADHD, care-as-usual for children aged 8-16 years with ADHD consists of psycho-education and the prescription of medication approved for ADHD and/or evidence-based parent and/or teacher-administered behaviour therapy, preferably both medication and behaviour therapy. First-line option for medication is a psychostimulant, second-line option is atomoxetine, and third-line options are alpha-2 presynaptic agonists or tricyclic antidepressants (imipramine).
15955689|NCT03220295|Drug|Single Dose of VU319|Single dose of VU319
15955690|NCT03220295|Drug|Single Dose Placebo|Single dose of placebo
15955691|NCT03220295|Other|Fed State|drug is given 30 minutes after a high fat breakfast
15955692|NCT03220295|Other|Fasted State|drug is given after an overnight fast
15955693|NCT03220295|Drug|Dose Escalation of VU319|dose levels of the cohorts will be increased step wise
15955694|NCT03220295|Drug|Placebo Dose Escalation|dose levels of the cohorts will be increased step wise
15955695|NCT03220282|Other|Donor milk|For late preterm newborns who are breastfeeding and whose mothers are not making enough breast milk yet to meet their nutritional needs, the study will compare the intervention of banked donor breast milk with the control of preterm infant formula.
15955696|NCT03220282|Other|Preterm infant formula|Preterm formula determined by clinical practice
15955697|NCT03220269|Other|Out-of-hospital cardiac arrest (OHCA)|Data collection
15955698|NCT03220269|Other|In-hospital cardiac arrest (IHCA)|Data collection
15955699|NCT03220256|Drug|Lamotrigine|The dose of lamotrigine (0.1mg) started to increase and gradually increased according to the drug tolerance induction protocol, and the efficacy was evaluated by dosing to the commercial capacity (100mg bid) within 2 weeks. In addition, the ratio of regulatory T cells was measured before lamotrigine administration, and the proportion of regulatory T cells was measured by two-week administration of lamotrigine after tolerance induction protocol. Add 6 ml of EDTA tube to each cryovial, and dispense 1 ml each in cryovial. After the appropriate number of patients of the same phenotype were collected, the analysis was performed.
15955702|NCT03220217|Drug|Satoreotide trizoxetan 30-45μg|Positron emission tomography (PET) imaging agent
15955703|NCT03220204|Behavioral|PP-based health behavior intervention|The positive psychology exercises include 3 modules: gratitude-based activities, strength-based activities, and meaning-based activities. The goal-setting portion of the program focuses primarily on physical activity (8 weeks) but also includes 4 weeks focusing on diet and medication adherence.
15955704|NCT03220204|Behavioral|MI-based educational control condition|The MI-based educational program includes information on five topics: (1) information about heart disease and risk factors for worsening heart disease, (2) physical activity, (3) a heart-healthy diet, (4) medication adherence, and (5) stress management.
15955705|NCT03220191|Drug|Palbociclib|palbociclib tablet formulation
15955706|NCT03220191|Drug|Rabeprazole|rabeprazole as PPI
15955707|NCT03220178|Drug|Palbociclib|Palbociclib 125mg/day orally dosed for 3 weeks followed by 1 week off; repeated for each treatment cycle
15955708|NCT03220178|Drug|Fulvestrant|500mg per use-after first application, again at wk2, then once per month
15955709|NCT03220178|Drug|Anastrozole|1mg per day
15955710|NCT03220178|Drug|Letrozole|2,5mg/day
15955711|NCT03220178|Drug|Exemestane|25mg/day
15955712|NCT03220165|Drug|MGL-3196|oral, 100 mg
15955713|NCT03220152|Drug|emtricitabine / tenofovir 200/300 mg|Fixed dose combination of emtricitabine / tenofovir 200/300 mg once daily orally during one year
15955714|NCT03220139|Other|fat intake|Observational study on fat intake and mortality
15955715|NCT03220126|Biological|LY3074828|Administered IV
15955716|NCT03220126|Biological|LY900021|Administered SC
15955717|NCT03220113|Combination Product|Dexamethasone, Lidocaine, Thiamine cohort|Bilateral and simultaneous administration of composition of De-Novo Treatment Cohort medication (Dexamethasone, Lidocaine, Thiamine) into the trigeminal and greater/lesser occipital nerves in one session.In children and hypersensitive individuals with needle phobia pre-treatment of skin with Lidocaine 2.5% Prilocaine 2.5% cream, and oral Alprazolam 0.25 mg (an Anxiolytic) 2 hours prior to initiation of procedure will be used.
15955718|NCT03220100|Other|Stepped Palliative Care|Palliative care clinicians will develop a therapeutic relationship with participants and address their symptoms, coping, prognostic awareness and illness understanding, treatment decision-making, and end of life care needs and preferences.
15955719|NCT03220087|Other|Data collection|The study consists of a single visit in which socio-demographic and clinical variables will be collected from the medical record or directly from the patient. In addition, the physician will provide information on the clinical status of the disease and the patient will fill in the questionnaire.
15955720|NCT03220074|Drug|Oral Tablet|study drug given and monitored for efficacy and tolerability
15955721|NCT03220061|Behavioral|music therapy|
15955722|NCT03220048|Drug|PrEP-001|
15955723|NCT03220048|Other|Placebo Comparator|
15955726|NCT03220022|Drug|Cyclophosphamide|Given IV
15955727|NCT03220022|Drug|Doxorubicin Hydrochloride|Given IV
15955728|NCT03220022|Drug|Etoposide|Given IV
15955729|NCT03220022|Biological|Filgrastim|Given SC
15955730|NCT03220022|Drug|Ibrutinib|Given PO
15955731|NCT03220022|Other|Laboratory Biomarker Analysis|Correlative studies
15955732|NCT03220022|Biological|Pegfilgrastim|Given SC
15955733|NCT03220022|Other|Pharmacological Study|Correlative studies
15955734|NCT03220022|Drug|Prednisone|Given PO
15955735|NCT03220022|Biological|Rituximab|Given IV
15955736|NCT03220022|Drug|Vincristine Sulfate|Given IV
15955737|NCT03220009|Procedure|Conventional Surgery|Undergo surgery
15955738|NCT03220009|Biological|Ipilimumab|Given IV
15955739|NCT03220009|Other|Laboratory Biomarker Analysis|Correlative studies
15955740|NCT03220009|Biological|Nivolumab|Given IV
15955741|NCT03220009|Other|Patient Observation|Undergo active surveillance
15955742|NCT03220009|Radiation|Radiation Therapy|Undergo RT
15955743|NCT03219996|Other|prognosis|The participants were divided into two groups based on survival at their hospital discharge.
15955744|NCT03219983|Drug|Ropivacaine|Patients will have an interscalene block under ultrasound guidance and receive .5% ropivacaine pre-operatively. Upon arrival to the Post-Operative Care Unit a continuous infusion of .5% ropivacaine will be started at 8ml/hr and increased by 2ml/hr every 15 minutes for pain score > 4 with a maximum rate of 14ml/hr. Infusion will be delivered by ON-Q Select-a-Flow pump (volume 750ml)
15955745|NCT03219983|Drug|liposomal bupivacaine|A total injection volume of 100ml will be comprised of 60ml 0.9% normal saline+ 20ml .5% bupivacaine + 20ml liposomal bupivacaine will be administered into the deep tissue of the operative are with an 18 or 20 gauge needle.
15955746|NCT03219970|Drug|Osimertinib|80mg oral daily
15955747|NCT03219957|Drug|AT-527|Ascending doses of AT-527 administered orally.
15955748|NCT03219957|Other|Placebo Comparator|Matching placebo
15955749|NCT03219944|Procedure|Platelet Rich Fibrin|: Platelet Rich Fibrin for soft tissue augmentation around implant in the aesthetic zone
15955750|NCT03219944|Procedure|sub epithelial connective tissue graft|sub epithelial connective tissue graft for soft tissue augmentation around implant in the aesthetic zone
15955751|NCT03219931|Drug|Bifidobacterium breve BR03 and Bifidobacterium breve B632|This is the active product containing 108 viable cells/strain
15955752|NCT03219931|Drug|Placebos|This is the placebo product containing a similar product without bifidobacterium inside.
15955753|NCT03219918|Device|EndoRings II Distal Attachment|Colonoscopy cap
15955754|NCT03219905|Device|Therapeutic Kinesio-taping|"The experimental group received a therapeutic Kinesio Tape application. Three I strips were applied to the both ankle joints for joint stability with subject's ankle at 90 degrees."
15955755|NCT03219905|Device|Sham Kinesio-taping|"The control group received a sham Kinesio Tape application. Ankle position was hold at minimally plantar flexion during taping. AI strip was placed from the anterior midfoot, not stretched and attached to the midline of anterior leg."
15955756|NCT03219892|Device|High-frequency rTMS|It is delivered at a 5-second burst of 10Hz stimuli, repeated 20 times at every minute. Each treatment contains a total of 1000 pulses. Stimulus intensity is 90% of resting motor threshold. The SMA stimulation will be given using a coil centered at points 3-cm anterior to the leg motor area in the sagittal midline.
15955757|NCT03219892|Device|Sham rTMS|The procedure will be same as the high-frequency rTMS except that the coil is 90° angled away.
15955758|NCT03219879|Behavioral|Telephone-administered continuation therapy|The intervention includes eight therapy sessions of approx. 50 minutes duration delivered over the telephone by trained psychotherapists over a time period of six months. The intervention is grounded in the principles of psychological continuation therapy and relapse prevention, and includes strategies such as transferring helpful elements of acute-phase cognitive-behavioral therapy (CBT) for depression to daily life. T-CT is offered in addition to usual care.
15955759|NCT03219879|Other|Usual care|Usual care without any study-related intervention
15955760|NCT03219866|Device|Nebulizers|Patients treated and discharged on nebulized bronchodilators
15955761|NCT03219866|Device|Dry Powder Inhaler|Patients treated and discharged on Dry Powder Inhalers
15955762|NCT03219866|Drug|Brovana|Subjects will receive a long-acting B2-agonist(LABA; Brovana, twice daily)
15955763|NCT03219866|Drug|Pulmicort|Subjects will receive a corticosteroid (ICS; Pulmicort, twice daily)
15955764|NCT03219866|Drug|Atrovent|Subjects will receive a short-acting anti-cholinergic (SAMA; Atrovent, three times a day)
15955765|NCT03219866|Drug|Advair Diskus|Subjects will receive a LABA/ICS (Advair Diskus, twice daily)
15955766|NCT03219866|Drug|Spiriva HandiHaler|Subjects will receive a long-acting anticholinergic (LAMA-Spiriva Handihaler, once daily)
15955767|NCT03219853|Dietary Supplement|selenium enriched parsnips|Parsnips which have been grown in a selenium enriched environment
15955768|NCT03219853|Dietary Supplement|Conventional parsnips|Parsnips which have been grown in a conventional environment
15955769|NCT03219840|Drug|Cetylpyridinium Chloride (CPC) 0.09% + Xylitol chewing gum|All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.
15955770|NCT03219840|Drug|Xylitol only chewing gum|All subjects will be instructed to chew four times a day, for at least 60 seconds, after which they expectorated.
15955771|NCT03219827|Other|Human biological samples|Blood samples collection
15955772|NCT03219814|Other|The Body Project|The Body Project is a dissonance-based body-acceptance program designed to help high school girls and college-age women resist cultural pressures to conform to the appearance ideal standard of female beauty and reduce their pursuit of unrealistic bodies. The Body Project is supported by more research than any other body image program and has been found to reduce onset of eating disorders.
15955773|NCT03219814|Other|Mediapsychoeducation|Mediapsychoeducation is used to educate individuals on psychological issues through the use of various medias, in this study mediapsychoeducation is being used to educate individuals on eating disorders and the thin ideal.
15955774|NCT03219801|Biological|mesenchymal stem cells|SLE patients in the treated group were given human umbilical cord derived mesenchymal stem cells by intravenous infusion and conventional therapy. There was only conventional treatment in the control group. All patients after treatment for 1, 3 and 6months were evaluated respectively the curative effect.
15955775|NCT03219788|Drug|Normal Saline|All the patient will be anesthetized using a standard anesthetic technique. One ml normal saline will be given
15955776|NCT03219788|Drug|Remifentanil 0.1 ug/kg|All the patient will be anesthetized using a standard anesthetic technique. One ml normal saline contains 0.1 ug/kg Remifentanil will be given
15955777|NCT03219788|Drug|Remifentanil 0.2 ug/kg|All the patient will be anesthetized using a standard anesthetic technique. One ml normal saline contains 0.2 ug/kg Remifentanil will be given
15955778|NCT03219775|Biological|Nivolumab/Ipilimumab|"Induction: Mono-Therapy with Nivolumab (240 mg i.V. / Q2W x 4)
~If CR/PR: Nivolumab Maintenance Mono-Therapy (240 mg i.V. / Q2W)
~If SD/PD: Nivolumab/Ipilimumab Boost 1+2-Combination Therapy (Nivo1 mg/kg i.V. and Ipi3 mg/kg i.V. / Q3W x 2)*
~If CR/PR: Nivolumab Maintenance Mono-Therapy (240 mg i.V. / Q2W)
~If SD/PD: Nivolumab/Ipilimumab Boost 3+4-Combination Therapy (Nivo 1 mg/kg i.V. and Ipi 3 mg/kg i.V. / Q3W x 2)
~If CR/PR/SD: Nivolumab Maintenance Mono-Therapy (240 mg i.V. / Q2W)
~since June 5, 2019, the treatment in all four boost cycles (1+2) and (3+4) is performed with nivolumab 1 mg/kg + ipilimumab 3 mg/kg (NIVO1/IPI3)"
15955779|NCT03219762|Drug|Nabpaclitaxel|Chemotherapy will be continued until a maximum of 6 courses or progressive disease or intolerable toxicity or patient refusal. In patients with confirmed and prolonged disease response, clinical benefit and good tolerance to study drug treatment, the investigators can evaluate to continue therapy beyond 6th cycle, after discussion with Principal Investigator (PI) of the study
15955780|NCT03219749|Behavioral|exercise training|Eligible participants will undergo 6 weeks of a combined aerobic and resistance exercise intervention. Training will take place 3 times per week for 1 hour. Forty minutes will be dedicated to aerobic training while 15 to 20 minutes will be devoted to resistance training.
15955781|NCT03219736|Procedure|Standard of Care therapies|If at any point during the treatment it is deemed medically necessary by the treating PED attending that a subject from the control arm (Group 1) requires an escalation of therapy, they may be moved from the group to the NIPPV/BiPAP group (Group 2) or be removed from the study (i.e. if intubated).
15955782|NCT03219736|Device|NiPPV Therapy|If at any point during the treatment it is deemed medically necessary by the treating PED attending that a subject from a NIPPV/BiPAP group (Group 2) is not tolerating NIPPV they may be removed from the study. Patients may not tolerate NIPPV due to agitation, vomiting or need for escalation of care.
15955783|NCT03219736|Procedure|Routine Respiratory Care|It may be up to the treating physicians discretion to treat patient with other medications that are currently used to treat severe asthma exacerbations, such as Epinephrine and Terbutaline
15955784|NCT03219723|Drug|Vonoprazan|Vonoprazan tablets
15955785|NCT03219723|Drug|Amoxicillin hydrate|Amoxicillin hydrate (potency)
15955786|NCT03219723|Drug|Clarithromycin|Clarithromycin (potency)
15955787|NCT03219723|Drug|Metronidazole|Metronidazole
15955788|NCT03219710|Drug|Ondansetron|Ondansetron will be given at a dosage of 0.15mg/kg IV/PO q8h.
15955789|NCT03219710|Drug|Dexamethasone|Dexamethasone will be given as 3mg/m2 IV/PO q8h.
15955790|NCT03219710|Drug|Aprepitant|Aprepitant will be given as per the weight. weight (15-40kg) - Day1 to Day 3 - 80 mg PO weight (>40 kg) - Day 1 -125mg , Day 2 & Day 3 - 80 mg PO
15955791|NCT03219710|Drug|Olanzapine|olanzapine will be given as 0.14mg/kg PO (rounded off to nearest 2.5 mg )
15955829|NCT03219411|Dietary Supplement|Cinnamon|Cinnamon burmannii administered orally as 500-mg capsules three times a day over 12 weeks
15955792|NCT03219697|Behavioral|Parenting education program|If you are in the parenting education program group, you will be enrolled in our 10-week parenting education program, followed by three monthly 1-hr sessions. You and/or your partner will attend weekly parenting sessions which will take place at the office of your child's primary care provider for 10 weeks, followed by 3 booster sessions. Our Toronto Public Health Nurse, will arrange 2-4 home visits with you and your family during the 6 months. This first home visit will include learning more about your routines at home, and what is available in your neighbourhood. The home visits will focus on helping to apply the messages and skills from the group sessions in your home, and making connections in your neighbourhood that you find helpful such as recreational or nutrition programs or other supports for your family.
15955793|NCT03219684|Diagnostic Test|serum protein ,kidney function ,liver function.,serum cholesterol|monthly review of serum protein kidney function ,liver function and serum cholesterol in all patients
15955794|NCT03219671|Drug|Nivolumab|nivolumab 240mg every 2 weeks
15955795|NCT03219671|Drug|Ipilimumab|ipilimumab 1 mg/kg every 6 weeks
15955796|NCT03219658|Behavioral|Parenting education sessions|If assigned to the parenting education session group, families will start with the 10-week group parenting education sessions and 2-4 home visits immediately after being enrolled. During this time, they will also come in for four one-on-one check-ins with the STOMP team. Each check-in will be approximately 1 hour. At least one parent/caregiver will attend weekly parenting sessions which will take place at SickKids. The Toronto Public Health Nurse will arrange 2-4 home visits with the family during the 6 month period of the study. The home visits will focus on helping to apply the messages and skills from the group sessions in their homes, and making connections in the neighbourhood to recreational or nutrition programs or other supports for the family.
15955797|NCT03219645|Drug|Ginkgo Diterpene Lactone Meglumine Injection|The injection must be added slowly into 0.9% sodium chloride injection and diluted to 250 ml , intravenous drip for about 2 hours.
15955798|NCT03219645|Drug|Acetylsalicylic acid|Acetylsalicylic acid (Aspirin) given in a total dose of 300 mg on the first day, followed by 100 mg once/day from Day 2 to Day 14.
15955799|NCT03219632|Drug|Fimasartan|Fimasartan is a non-peptide angiotensin II receptor antagonist (ARB) used for the treatment of hypertension and heart failure.
15955800|NCT03219619|Device|Cap-EGD|Undergoing cap-assisted endoscopy
15955801|NCT03219619|Device|Duo|Undergoing side-viewing duodenoscope
15955802|NCT03219606|Other|Organized education course of Modified Rodnan Skin Scoring|"Lecture: An expert rheumatologist (master instructor) give a lecture to explain the technique of Modified Rodnan Skin Scoring (MRSS).
~Demonstration: Master instructor demonstrate the patient assessment without revealing his score.
~Practical training: Participants assess the MRSS of 8 patients with systemic sclerosis. Two other expert rheumatologists assist the course."
15955803|NCT03219593|Drug|Apatinib mesylate tablets|Apatinib is taken 500 mg every day orally, half hour after breakfast with warm water. The drug is taken 4 weeks one cycle until disease progression or intolerable toxicity or death. The dose of the study drug may be decreased to 250 mg/d following the occurrence of a clinically significant adverse event (AE). Treatment will be discontinued if the subject is unable to tolerate a daily dose of 250 mg.
15955804|NCT03219580|Drug|5-Fluorouracil|50mg/ml concentration of 5-Fluorouracil to be injected intra-dermally in direct brow skin incisions
15955805|NCT03219580|Drug|Normal Saline Flush, 0.9% Injectable Solution|0.9% concentration of Normal Saline Injectable Solution to be injected intra-dermally in direct brow skin incisions
15955806|NCT03219554|Drug|Palbociclib|oral palbociclib 125mg daily for 21days followed by a 7-day break. Cycle will be repeated every 28 days.
15955807|NCT03219541|Behavioral|Interventional Automated mobile phone text|Participants will receive 2 messages per day in the pre-quit phase, 3 messages per day on the quit date and the first week in the post-quit phase, and 2 messages per day in the last 3 weeks of the intervention.
15955808|NCT03219541|Behavioral|Control Automated mobile phone text|Participants will receive 2 text questions each week asking the number of smoking days in the past week and the average number of cigarette smoked per day.
15955809|NCT03219528|Drug|Rifaximin 550 MG|Rifaximin 550 mg three times daily for 14 days
15955810|NCT03219528|Other|Low FODMAP Diet|Low FODMAP dietary intervention for 4 weeks
15955811|NCT03219515|Drug|Gongjin-Dan|Gongjin-dan (Iksu Pharmaceutical Co. Ltd, Gwangju, Republic of Korea) is composed of Cervi Parvum, Angelica Gigas Root, Cornus Fruit, Ginseng, Steamed Rehmannia Root, and Musk.
15955812|NCT03219515|Drug|Placebo|Placebo drugs (similar in appearance, taste, and odor to the Gongjin-dan) contains excipients, coloring agents, binders, flavoring agents, and preservative, and gilt-paper covering. Placebo pills of Gongjin-dan will be also made by Iksu Pharmaceutical Co. Ltd, Gwangju, Republic of Korea.
15955813|NCT03219502|Other|Best Practice|Receive standard of care
15955814|NCT03219502|Other|Quality-of-Life Assessment|Ancillary studies
15955815|NCT03219502|Other|Questionnaire Administration|Ancillary studies
15955816|NCT03219502|Procedure|Repetitive Transcranial Magnetic Stimulation|Undergo rTMS
15955817|NCT03219502|Procedure|Sham Intervention|Undergo sham rTMS
15955818|NCT03219489|Other|Electronic medical record alert|"An electronic medical record alert will be inserted into the clinic's electronic medical records. The alert reads: Consider Progesterone 100-200 mg pv qhs > or =16 weeks, if previous spontaneous PTB or current short cervix, and no allergies to peanuts or progesterone.
~This alert will appear on the Ministry of Health-mandated Perinatal Records."
15955819|NCT03219476|Drug|Anastrozole|1 mg once daily.
15955820|NCT03219476|Drug|Letrozole|2.5mg once daily.
15955821|NCT03219476|Drug|Exemestane|25 mg once daily.
15955822|NCT03219476|Drug|Tamoxifen|20 mg once daily.
15955823|NCT03219463|Dietary Supplement|Ginger|3g ginger powder supplement once a day with meals (preferably in the morning) for a duration of 8 weeks. Powder can be mixed with juice or water.
15955824|NCT03219450|Drug|NeoVax|It stimulates the immune system to attack cancer cells.
15955825|NCT03219450|Drug|Cyclophosphamide|It is a chemotherapy drug used to treat many cancers. At low doses, it is an investigational drug to help the immune cells to be better at attacking cancer cells while avoiding chemotherapy toxicity.
15955826|NCT03219450|Drug|Pembrolizumab|Is a monoclonal antibody that helps the immune cells to be better at attacking cancer cells.
15955827|NCT03219437|Drug|risankizumab|subcutaneous (SC) injection
15955828|NCT03219437|Drug|methotrexate|capsule
15955830|NCT03219411|Other|placebo|Placebo administered orally as capsules three times a day over 12 weeks
15955831|NCT03219398|Procedure|Pneumoperitoneum pressure|Subjects were set to 8- 10 mmHg pressure during laparoscopic surgery; Subjects were set to 12-14 mmHg pressure during laparoscopic surgery
15955832|NCT03219385|Device|Mirabilis System|The intervention is a transabdominal treatment performed with the Mirabilis System, during which high-intensity focused ultrasound (HIFU) is applied noninvasively through the skin using an applicator placed against the abdomen. One or more appropriately selected uterine fibroids will be treated with HIFU using integrated ultrasound imaging to guide the treatment. HIFU causes localized heating and mechanical effects to develop in the targeted fibroid(s) that result in therapeutic destruction of the fibroid tissue, leading to improvement in related symptoms.
15955833|NCT03219372|Drug|Pravastatin Pill|statin
15955834|NCT03219372|Drug|Placebo Oral Tablet|placebo
15955835|NCT03219359|Procedure|Autologous stem cell transplant|Hematopoietic stem cell transplantation
15955836|NCT03219359|Drug|Cyclophosphamide|Days 1 and 2: Cyclophosphamide 2gm/m2/day x 2 days (total dose 4gm/m2) Day 3 until leukapheresis: G-CSF 10μg/kg/day to CD34+ >20x104/ml then leukapheresis daily to collection goal
15955837|NCT03219359|Drug|Cyclophosphamide|Day -5 to -2: Cyclophosphamide 50 mg/kg/day (200 mg/kg total dose)
15955838|NCT03219359|Drug|Thymoglobulin|Day -3 to -1: 2.5 mg/kg/day (7.5 mg/kg total dose)
15955839|NCT03219359|Drug|Methylprednisolone|Day -3 to -1: 1mg/kg prior to each ATG dose
15955840|NCT03219359|Drug|Vedolizumab|Starting first day after discharge from transplant admission, then 2 weeks after 1st infusion, 4 weeks after 2nd infusion, followed by every 8 weeks for 52 weeks (8 doses)
15955841|NCT03219346|Other|oral care program|Oral care (sputum and special needs of people cleaning teeth) time for three days a week (with swallowing treatment time before), once a day, each about 10 minutes of oral care program.
15955843|NCT03219320|Drug|NYX-2925|NYX-2925 is a novel small molecule that modulates the N-methyl-D-aspartate receptor (NMDAR).
15955844|NCT03219320|Drug|Placebo|Matching Placebo capsules.
15955845|NCT03219307|Combination Product|NOVOCART 3D|Matrix associated autologous chondrocyte implant
15955846|NCT03219294|Drug|Vecuronium 0.1 mg/kg|Vecuronium will be administered to achieve and maintain 1 to 2 TOF contractions.
15955847|NCT03219294|Drug|Vecuronium 0.2mg/kg|Vecuronium will be administered to achieve and 0 TOF/PTC 1-2.
15955850|NCT03219255|Drug|RELVAR 100 ELLIPTA|RELVAR 100 ELLIPTA contains fluticasone furoate, an inhaled corticosteroid and vilanterol, an ultra-long-acting Beta-2 agonist and it is indicated for the treatment of COPD (bronchitis chronic/emphysema). Post-marketing investigation of RELVAR 100 ELLIPTA will be carried out in this analysis.
15955851|NCT03219242|Device|Caiman® device|Using CAIMAN device in primary surgery for ovarian cancer. Analyze potential time-sparing and the incidence of post-surgical complications.
15955852|NCT03219216|Drug|Glecaprevir/Pibrentasvir|Film-coated tablet
15955853|NCT03219203|Biological|Hepatitis B vaccine|Hepatitis B vaccine (20 µg/ml) 1 ml intramuscular injection in single (at 0 month) or 3-dose series (at 0, 1, 6 months)
15955854|NCT03219190|Behavioral|LST High School Online|The proposed preventive intervention for high school PDA will (1) utilize both online e-learning modules and interactive classroom sessions to address PDA and concurrent alcohol/drug abuse; (2) positively change social norms surrounding PDA and alcohol/drug abuse; (3) challenge positive expectancies about the benefits of PDA; (4) discourage diversion of prescription medication; (5) enhance protective factors by building social, self-regulation, and relationship skills through interactive learning and behavioral rehearsal scenarios; and (6) include online booster sessions.
15955855|NCT03219177|Behavioral|Patient education regarding indications for opioid use and side effects of opioid use after hand surgery|Patients in the active education group will be given information pre-operatively on the current opioid epidemic, alternative pain management strategies that should be tried before proceeding to prescription opioid use, appropriate indications for opioid use, and side effects of opioids.This information will be reinforced by the research coordinator and nursing staff in the post-anesthesia care unit.
15955856|NCT03219177|Other|Standard of care post-operative counseling|Patients will receive standard of care post-operative counseling. They will not be given pre or post-operative opioid education.
15955859|NCT03219151|Device|eMAR game|The eMAR simulator videogame affords students a virtual and immersive opportunity to practice medication administration using an eMAR system, in a structured fashion that provides real-time feedback related to best-practices and safety compliance of the medication process
15955860|NCT03219151|Other|Normal pre-work|Participants complete normal education pre-work related to eMAR administration, in advance of simulated return-demonstration
15955861|NCT03219138|Device|Acceleromyography|Use of an uncalibrated acceleromyography
15955862|NCT03219125|Device|Dixon Magnetic Resonance Imaging|MRI of the lumbar spine (L1 to L4) and hip (non-dominant) for the measurement of Ad Med. (In%) by the DIXON sequence.
15955863|NCT03219125|Device|dual-energy X-ray absorptiometry (DXA)|Subjects will undergo DXA scan to assess total body (less head) and lumbar spine bone mineral density.
15955864|NCT03219112|Other|Balance rehabilitation using X-box One & Kinect|the virtual reality games (Kinect sports rivals) can be controlled with movements of the body that are registered through the kinect camera.
15955865|NCT03219086|Procedure|combined spinal epidural anaesthesia|To give surgical anesthesia for performance of the caesarian section a combined spinal epidural anesthesia will be performed with different spinal solutions according to the appointed study group
15956495|NCT03214406|Drug|Arm & Hammer Advance White Brilliant Sparkle (Test product)|20% sodium bicarbonate
15955866|NCT03219086|Drug|Prilocaine|A combined spinal epidural anesthesia with spinal administration of 50 mg hyperbaric prilocaine 2% (Tachipri, Nordic Pharma) + 2,5mcg sufentanyl (5 mcg/ml) (Janssens-cilag)
15955867|NCT03219086|Drug|Bupivacaine|combined spinal epidural anesthesia with spinal administration of 7,5 mg hyperbaric bupivacaine 0,5% (Marcaine H) + 2,5mcg sufentanyl ( 5 mcg/ml)( Janssens -cilag) +1 ml nacl0,9%
15955868|NCT03219073|Device|Active tDCS using tDCS device|Active tDCS using tDCS device is a noninvasive brain stimulation technique that utilizes low amplitude direct currents applied via scalp electrodes to apply currents to the brain and modulate the level of cortical excitability. tDCS applied over the dorsolateral prefrontal and motor cortex has been reported to be able to decrease pain sensation and to increase pain threshold in healthy subjects and is effective in reducing central chronic pain in PwMS.
15955869|NCT03219073|Device|SHAM tDCS using tDCS device|SHAM tDCS emulates active tDCS in all but the actual stimulation. Electrodes of the tDCS device are placed in the same place as with active tDCS however no current is activated.
15955870|NCT03219060|Behavioral|Motivational interviewing for smoking cessation in nurses|Intervention, four one-to-one sessions on an approximately weekly basis, with 3 components: MI context, toolkit, and relapse prevention. The sessions were embedded in a MI context and followed two phases: exploratory and resolutive. The former explored the potential ambivalence that nurses experienced and constructed motivation for change; the latter reinforced the decision to quit and developed a change plan. Participants could choose over a range of tools: some more helpful in the exploratory phase (i.e. decisional balance sheet) and others in the resolutive phase (i.e. problem solving skills). The third component was directed at maintenance strategies. The therapy stayed with the nurses in terms of where they were in relation to they readiness for change.
15955871|NCT03219060|Behavioral|Brief advice|Brief advice based on 5As
15955872|NCT03219047|Other|Best Practice|Receive standard of care
15955873|NCT03219047|Drug|Ibrutinib|Given at standard dose and schedule
15955874|NCT03219047|Other|Patient Derived Xenograft|Xenograft developed
15955875|NCT03219047|Other|Personalized Medicine|Receive treatment based on the results of the PDX models
15955876|NCT03219034|Device|oral appliance - A|Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth and uses a Midline Traction Mechanism to advance the mandible. The coupling mechanism is located at a single point midline, allows adjustment by incremental protraction (advancement) of the mandible.
15955877|NCT03219034|Device|oral appliance - B|Anti-snoring intra-oral appliance that consists of two custom fitted trays which fit over the upper and lower teeth uses a Bilateral Thrust Mechanism to advance the mandible. The trays are engaged by means of adjustable lugs.
15955878|NCT03219008|Drug|Fluoxetine|Fluoxetine is one kind of selective serotonin reuptake inhibitor(SSRIs), whose effect is much better than other non-underload subtypes compared with underload subtypes.So patients would be treated with fluoxetine only.
15955879|NCT03219008|Combination Product|fluoxetine + cognitive-behavioral treatment（CBT）|the investigators would recommend fluoxetine to help to cure depressive disorder.And CBT is a very effective way for patients to alleviate or relieve clinical symptoms during episode stage.
15955880|NCT03219008|Drug|fluoxetine + Amfebutamone|Amfebutamone is one kind of SNRIs, and it shows much better therapy effect on patients with exhaustion /dizziness.So the investigators recommend these two drugs to help to cure patients with depressive disorder.
15955881|NCT03219008|Combination Product|physical treatment+fluoxetine+amfebutamone|the investigators recommend drug(fluoxetine and amfebutamone) and physical treatment as intervention.
15955882|NCT03219008|Drug|Fluvoxamine|Fluvoxamine could inhibit CYP1A2 and CYP2C19 and affect the metabolism of melatonin, and help to release symptoms of depressive disorder with sleep problems.
15955883|NCT03219008|Drug|Lithium+fluvoxamine|the investigators recommend lithium as a mood stabilizer and use fluvoxamine to affect the level of melatonin.
15955884|NCT03219008|Combination Product|fluvoxamine + lithium + physical therapy|the investigators recommend depressants and mood stabilizers as well as physical therapy to help to cure depressive disorder.
15955885|NCT03219008|Combination Product|Cognitive behavior treatment +fluvoxamine|the investigators recommend behavioral therapy as well as drugs.
15955886|NCT03219008|Drug|Mirtazapine/SNRIs|Mirtazapine is one kind of antagonist of a2 adrenergic receptors and could block 5-hydroxytryptamine2 and 5-hydroxytryptamine3,help to release symptoms like anxiety or somatization.Besides, SNRIs could also make similar effect on patients.Therefore, the investigators recommend mirtazapine/SNRIs to treat patients with depressive disorder.
15955887|NCT03219008|Combination Product|mirtazapine+ Cognitive behavior treatment|the investigators recommend CBT and mirtazapine as interventions.The dosage and frequency would depend on patients' severity of symptoms .
15955888|NCT03219008|Drug|mirtazapine + SNRIs|the investigator recommend mirtazapine and SNRIs to treat patients with major depressive disorder.
15955889|NCT03219008|Combination Product|mirtazapine + SNRIs + physical therapy|the investigators would manage to use drugs and physical treatment to help to release the symptoms of depressive disorder.
15955890|NCT03219008|Other|TAU(treat as usual)|patients in this group would receive therapy strategies according to their symptoms and preference.
15955891|NCT03218995|Drug|Eteplirsen|"Eteplirsen will be administered once a week by IV infusion for up to 96 weeks.
~The starting dose is 2 mg/kg eteplirsen, with escalation to 4, 10, 20, and 30 mg/kg over the course of the dose-titration period."
15955892|NCT03218982|Behavioral|Enhanced psycho-education about dementia and caregiving|Enhanced psycho-education re dementia and caregiving helping family members come to shared understanding of the nature and cause of dementia. Discussion of cultural values in Vietnamese and American cultures and how this can influence perceptions of dementia and caregiving strategies will help family members who disagree on the etiology of dementia and strategies for care to empathize with each other's perspective. Other sessions will teach skills to develop self-efficacy in dealing with patient symptoms, to access resources (e.g., in-home support), and to gain family support in culturally-congruent ways. Mindful Tai Chi is rooted in East Asian traditions and philosophies that promote balance and healing of the mind and body, thus addressing holistic beliefs Vietnamese have about wellness.
15955893|NCT03218969|Drug|Ecopipam|oral drug in subjection currently experiencing dopamine agonist induced augmentation
15955894|NCT03218969|Drug|Placebo|matching placebo
15956004|NCT03218059|Procedure|Methotrexate Combined With Transvaginal Surgery|The methods of treatment of CSP
15955895|NCT03218956|Dietary Supplement|Dietary supplement: Protein intake|"Oral consumption of houly experimental meals. Includes 4 meals containing a mixture of free amino acids, carbohydrates from a flavored liquid, fat from corn oil and protein free cookies.
~The last 4 meals will in addition contain labelled labelled 13C phenylalanine."
15955896|NCT03218943|Device|APRV ventilation mode|They will start on APRV mode with high pressure (Phi) 20 cmH2O , low pressure(Plo) 5 cmH2O with I:E ratio ( Phi phase: Plo phase ratio ) 4:1 for 3 hours
15955897|NCT03218943|Device|BIPAP ventilation moood|start on BiPAP mode with high pressure (Phi) 20 cmH2O , low pressure(Plo) 5 cmH2O with I:E ratio ( Phi phase: Plo phase ratio ) 1:1 for 3 hours
15955898|NCT03218930|Behavioral|Delayed antibiotic prescription|Delayed antibiotic prescription pads will be disseminated to all participating general practitioners in both hard and soft copies.
15955899|NCT03218930|Behavioral|Antibiotic prescribing guidelines|Antibiotic prescribing guidelines will be disseminated to all participating general practitioners in both hard and soft copies.
15955900|NCT03218930|Behavioral|Education|General practitioners will receive a package of educational sessions tailored towards their specific needs.
15955901|NCT03218930|Behavioral|Educational materials|Educational materials for patients, namely posters and leaflets, will be disseminated to all participating general practitioners.
15955902|NCT03218917|Drug|INS1007 10 mg oral tablet|Administered once per day for 24 weeks
15955903|NCT03218917|Drug|INS1007 25 mg oral tablet|Administered once per day for 24 weeks
15955904|NCT03218917|Drug|Placebo Oral Tablet|Administered once per day for 24 weeks
15955905|NCT03218904|Dietary Supplement|Glucose intake|Experiment 1: study day1- single oral dose of glucose study day 2-single oral dose of glucose with U-13C-glucose
15955906|NCT03218904|Dietary Supplement|Carbohydrates intake|Experiment 2:study day1- single oral dose of uncooked cornstarch study day 2-single oral dose of uncooked cornstarch with U-13C-glucose study day 3- single oral dose of Glycosade® study day 4-single oral dose of Glycosade® with U-13C-glucose
15955907|NCT03218891|Behavioral|Cardiac Rehabilitation|"The physical training program will start shortly after the initial exams have been completed. The physical training protocol will consist of a 12-week duration, with a frequency of 3 weekly sessions of 60 minutes duration each. The intensity will be prescribed from the echocardiogram with effort and cardiopulmonary test. All sessions will be monitored by telemetry and will be distributed as follows:
~5 minutes warm up
~30 to 40 minutes of aerobic exercise (treadmill). The training intensity will be prescribed individually, based on the results of the test results;
~10 minutes of localized exercises;
~5 minutes of relaxation."
15955908|NCT03218865|Device|VIE high flux dialyzer|Asssesment of the therapeutic effect of the vitamin E coating
15955909|NCT03218865|Device|Leoceed H high flux dialyzer|Use of the Leoceed H dialyzer during one year per patient enrolled in the control group
15955910|NCT03218852|Drug|prednisone and cyclophosphamide|Prednisone and cyclophosphamide are both administered to participants in this group.
15955911|NCT03218852|Drug|prednisone alone|Prednisone is administered to participants in this group.
15955912|NCT03218839|Device|PrePex male circumcision device|PrePex non-surgical male circumcision device applied to eligible, consenting HIV-infected men in Zimbabwe to determine the rate of adverse events as compared to non HIV-infected men.
15955913|NCT03218826|Drug|Docetaxel|Given IV
15955914|NCT03218826|Other|Laboratory Biomarker Analysis|Correlative studies
15955915|NCT03218826|Other|Pharmacological Study|Correlative studies
15955916|NCT03218826|Drug|PI3Kbeta Inhibitor AZD8186|Given PO
15955917|NCT03218813|Behavioral|Intervention cohort ('after' group)|"The intervention will take place during hospitalisation. Patients will complete the BMQ-S and their responses will form the basis of what will be discussed in Session 1. Pharmacists will elicit patients' thoughts and opinions about their medicines and highlight the need to take them. Any erroneous treatment beliefs will be discussed and any concerns will be addressed.
~After Session 1, patients will be given a planning sheet and will be asked to think about their usual daily routine and how taking medicines may fit into it. Session 2 will focus on developing specific action plans for taking medication at home. Patients will be asked to formulate an if-then plan ('If it is time X in place Y and I am doing Z, then I will take my pill dose')."
15955918|NCT03218800|Combination Product|Ertapenem|"Dose: 1g per day if creatinine clearance > 30mL/min or 500 mg per day if creatinine clearance < 30mL/min.
~Dilution: 50 ml saline solution. Duration 30 minutes."
15955919|NCT03218787|Device|XIENCE|Subjects who received XIENCE family stent systems will be included.
15955920|NCT03218787|Drug|DAPT|"3-month clear subjects who receive 3-month DAPT without interruption of either aspirin and/or P2Y12 receptor inhibitor for > 7 consecutive days.
~Subject who are 3-month clear will discontinue P2Y12 inhibitor after 3-month visit, but continue taking aspirin through 12-month follow-up. Subjects who are not eligible for early P2Y12 inhibitor discontinuation will be treated per site standard of care."
15955921|NCT03218774|Behavioral|Home Exercise Group|The Home group will meet with an exercise professional once and be given a home exercise program to complete 3 to 5 times per weeks at home.
15955922|NCT03218774|Behavioral|Fitness Center Group|The Center group will be given an exercise program, a membership to a community fitness gym where they will be asked to exercise 3-5 times per week, and will be provided with 6 individual personal training sessions.
15955923|NCT03218761|Diagnostic Test|NET mRNA level|quantification of mRNA to the Norepinephrine Transporter (NET)
15955924|NCT03218761|Diagnostic Test|Plasma catechols|plasma for assay of norepinephrine (NE), DHPG (intraneuronal metabolite of NE), and other catechols
15955925|NCT03218761|Diagnostic Test|Urine Catechols|urine for assay of norepinephrine (NE), DHPG (intraneuronal metabolite of NE), and other catechols
15955926|NCT03218748|Behavioral|Honest, Open, Proud (HOP)|"Three lessons, one for each two-hour session plus one booster session
~Considering the pros and cons of disclosure:
~Discussion of one's idea of identity and mental illness, weighing the costs and benefits of (non-) disclosure
~Different ways to disclose:
~Discussion of different levels of (non-) disclosure, considering costs and benefits of each level, selecting persons to disclose to and how to test them out, anticipating responses of others to one's disclosure
~Telling one's story:
~Practice how to tell one's story, identifying peers who might be helpful with the coming out process
~Booster session Reviewing previous intentions to disclose one's mental illness, discussion whether one disclosed and evaluating this experience"
15955927|NCT03218735|Procedure|Labor induction at 37.0 weeks to 37.6 weeks of gestation|Diagnosis of LGA with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days
15955928|NCT03218735|Procedure|Expectant monitoring and delivery|Diagnosis of LGA with expectant monitoring and delivery as indicated by standard obstetric practices
15955929|NCT03218722|Drug|Pro-Thrombin Concentrate Complex|Patient at risk of massive hemorrhage will be managed with standard care with 1ml/kg PCC.
15955930|NCT03218722|Drug|NaCl 0.9%|Patient at risk of massive hemorrhage will be managed with standard care with 1ml/kg Saline solution.
15955931|NCT03218709|Combination Product|High-dose multi-vitamins with minerals|The high-dose multi-vitamins with minerals contained vitaminB1 0.72mg,vitamin B20.72mg,vitamin B12 1.35μg,folic acid 0.37mg,vitamin C 0.27mg,vitamin D 5.04μg,selenium 30.5μg per pill, respectively.
15955932|NCT03218709|Combination Product|Low-dose multi-vitamins with minerals|The low-dose multi-vitamins with minerals contained vitaminB1 0.72mg,vitamin B20.72mg,vitamin B12 1.35μg,folic acid 0.20mg,vitamin C 0.50mg,vitamin D 5.04μg,selenium 30.5μg per pill, respectively.
15955933|NCT03218709|Combination Product|Hypouricemic tablets|The hypouricemic tablets contained skipjack,salvia and rosemary extract.
15955934|NCT03218709|Combination Product|Placebo|The placebo tablets contained maltodextrin and tartrazine.
15955935|NCT03218696|Device|Cough Syrup for adults and children|The intervention product is a medical device in Europe due to its non-pharmacological mode of action, which makes the product compliant to the medical device definition. It is made of specific extracts of plants (plantago and thymus) which provide the product with protective characteristics of the oropharynx. These protective features enable the syrup to reduce the irritative cough promoting stimuli on the throat, which decrease urge to cough threshhold. In addition to these extract, honey completes the formula. The product does not contain any artificial component and no preservatives.
15955936|NCT03218696|Device|Placebo|The placebo intervention is a syrup of same taste and colour without the natural protective components but with the necessary synthetic preservatives and other co-sweeteners to guarantee quality and safety. The placebo has, in fact, all the features of a cough syrup since true placebo syrup is not possible in cough. The lack of specific natural protective components is weighed against the presence of other necessary substances which may still have an effect on cough, but this effect is not envisaged to be a specific protective effect.
15955939|NCT03218657|Drug|levamisole hydrochloride|levamisole hydrochloride take orally 150mg qod
15955940|NCT03218657|Drug|Androgens|Androgens take orally 80mg qd
15955941|NCT03218657|Drug|Cyclosporins|Cyclosporines take orally 3-5mg/kg*d qd
15955942|NCT03218644|Other|Mobility exercises|Usual treatment and exercises of cervical mobility before a mirror.
15955943|NCT03218644|Other|Proprioception exercises|proprioceptive exercises for craniocervical sensorimotor control.
15955944|NCT03218631|Drug|Oxandrin|"The primary outcome for this study will be measurements of the pharmacokinetics of a single dose of oxandrolone 0.1 mg/kg both in tablet form and in the MCT oil preparation. Blood samples for pharmacokinetics will be drawn at 9 timepoints.
~Safety will be assessed by recording adverse events and assessment of hepatic function at baseline and one week following oxandrolone dosing."
15955945|NCT03218605|Other|physical activity|Subjects performed five activities: running, static stretch, dynamic stretch, cycling and rope skipping
15955946|NCT03218592|Drug|Maraviroc Pill|Subjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weekly
15955947|NCT03218592|Drug|Dolutegravir Pill|Subjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weekly
15955948|NCT03218592|Drug|Truvada Pill|Subjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weeklySubjects will take a single dose in Phase 1, Daily Doses in Phase 2 for 28 days, and then be randomized in Phase 3 to zero doses, one dose a week or three doses weekly
15955949|NCT03218579|Dietary Supplement|Probiotic treatment|4 weeks of probiotic treatment after 7 days of antibiotics (Metronidazole+Ciprofloxacin)
15955950|NCT03218579|Biological|Bacteriotherapy|Bacteriotherapy (autologous fecal microbiota transplantation) after 7 days of antibiotics (Metronidazole+Ciprofloxacin)
15955951|NCT03218566|Device|Indigo Aspiration System|use of mechanical thrombectomy to treat pulmonary embolism
15955952|NCT03218553|Drug|Dexamethasone|Dexamethasone : first dose : 0,2mg.kg-1 at the end of the surgical procedure, second dose (0,2 mg.kg-1) 24 hours after the surgery
15955953|NCT03218553|Drug|Placebos|placebo : first infusion at the end of the surgical procedure, second 24 hours after the surgery
15955954|NCT03218540|Procedure|Fluid management protocol|SVV protocol: keep SVV 10-13% and give fluid when SVV > 13% CVP protocol: keep CVP 8-12 mmHG and give fluid when CVP < 8 mmHg
15955955|NCT03218514|Drug|Dalteparin|
15955956|NCT03218501|Drug|SK-1405 high dose|SK-1405 high dose is to be administered orally once daily for 2 weeks
15955957|NCT03218501|Drug|SK-1405 low dose|SK-1405 low dose is to be administered orally once daily for 2 weeks
15955958|NCT03218501|Drug|Placebo|Placebo is to be administered orally once daily for 2 weeks
15955960|NCT03218475|Other|MR Guided Focused Ultrasound|Two treatments of focused ultrasound under MRI guidance
15955961|NCT03218462|Behavioral|Sensory Adapted Dental Environment (SADE)|No fluorescent room lights, solar projector on ceiling, regular dental x-ray apron laying on patient, quiet music playing in background
15956005|NCT03218046|Behavioral|EMDR|Eye Movement Desensitisation and Reprocessing
15955962|NCT03218436|Procedure|CAP treatment|Treatment with low-temperature argon plasma during colposcopic examination. No general anesthesia required.
15955963|NCT03218423|Device|Epi proColon|Plasma cell free DNA SEPT9 promoter methylation test for colorectal cancer screening.
15955964|NCT03218410|Procedure|surgical pulmonary embolectomy|
15955965|NCT03218410|Combination Product|catheter-directed thrombolysis|
15955966|NCT03218397|Device|Accelerate PhenoTest™ BC Kit|Rapid identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX)
15955967|NCT03218397|Device|Standard Culture and AST|Standard culture and antimicrobial susceptibility testing (AST)
15955968|NCT03218384|Drug|Ferric Carboxymaltose|750 MG Iron Per 15 ML Injectable Solution
15955969|NCT03218384|Drug|Placebo|normal saline
15955970|NCT03218371|Procedure|chandelier-assisted peripheral vitrectomy under air|chandelier-assisted peripheral vitrectomy under air for management of peripheral vitreous during RD vitrectomy; whether using indentation or non-indentation
15955971|NCT03218345|Procedure|EUS-guided RFA|EUS-guided RFA would be performed using a 19-gauge RFA electrode and a generator
15955972|NCT03218332|Diagnostic Test|Biomarkers for detecting possible CTE invivo|Detection biomarkers for possible CTE: Imaging/blood/CSF/PET-tau/MRI/europsychological assessment
15955973|NCT03218319|Biological|Renin measurement|patients will have a blood sample for measuring renin activity
15955974|NCT03218306|Device|Surgical Pleth Index|Effector site concentration of remifentanil based on SPI
15955975|NCT03218306|Other|Clinical guidance|Effector site concentration of remifentanil based on hemodynamic data
15955976|NCT03218293|Device|RIPC device (IPC-906X)|Patients in the RIPC group had five cycles of 5-min cuff inflation followed by 3-min deflation to the bilateral upper arm after thrombolysis.
15955977|NCT03218280|Drug|Vitamin C|
15955978|NCT03218267|Other|Static Posturography|The balance platform (Good Balance by Metitur) and one leg standing test (OLS) were used to assess the static balance. OLS test was performed on left and right foot separately. The static posturography was performed with several various positions of feet. Position : normal standing with eyes open and eyes closed - an upright standing with feet placed parallel 20 cm apart for 30 s. Position: tandem - a stance with one foot placed ahead of the other for 10 s. Position: second form of tandem - a stance with one foot placed ahead of the other with feet placed on both sides of the line dividing platform to two parts for 20s. Position: one leg standing: stance on the one leg for 5 s.
15955979|NCT03218267|Other|One-leg standing test (OLS)|During the one-leg standing test (OLS) the time of maintain this position by the patients was measured. The placement of the limbs was the same as in the case of the balance platform test. Subjects performed 3 trials on each lower limb. Time ended when subject either: loosed balance and touched raised foot the floor, moved supporting leg on the ground, a significant loss of balance or a maximum of 60 s had elapsed. Results achieved by the subjects after THR on both operated (OLS-O) and non operated limbs (OLS-N) were compared with the index of the control group (OLS-C: mean result of the tests performed on the left and right legs).
15955980|NCT03218254|Drug|Methylphenidate|Titration of MTP for treatment of fatigue
15955981|NCT03218254|Drug|Placebo|Placebo
15955982|NCT03218241|Biological|PRT064445|Intravenous
15955983|NCT03218241|Drug|Placebo|Intravenous to mimic PRT064445
15955984|NCT03218228|Procedure|implants in periodontitis|it targets immediate implant placement in patients suffering from aggressive periodontitis
15955985|NCT03218189|Other|Country characteristics|Observational study of country characteristics
15955986|NCT03218176|Device|Proximal single upper limb|Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
15955987|NCT03218176|Device|Proximal staggered upper limb|Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
15955988|NCT03218176|Device|Distal single upper limb|Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
15955989|NCT03218176|Device|Distal staggered upper limb|Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
15955990|NCT03218176|Device|Proximal single lower limb|Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
15955991|NCT03218176|Device|Proximal staggered lower limb|Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
15955992|NCT03218176|Device|Distal single lower limb|Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
15955993|NCT03218176|Device|Distal staggered lower limb|Measurement of pain, pressure under tourniquet, feeling and abolition of pulse doppler and pulse oximetry
15955994|NCT03218163|Drug|MEDI-551 Maintenance|Cycle 1 - Days 1, 8, 15, and 22: 4mg/kg IV Cycles 2-12 - Day 1: 4mg/kg IV
15955995|NCT03218150|Procedure|cranioplasty|". The margins of the craniectomy defects exposed, and the bone flaps fixed in their original positions using wires or titanium plates with screws. As prophylaxis, all patients intravenously administered with pre- and postoperative antibiotics.
~In cases of artificial substitutes , The polymethyemethacrylate implant fixed to the defective region with titanium plates and self-tapping screws."
15955997|NCT03218124|Other|Remifentanil Effect site concentration|"After skin suture, a predetermined Effect site remifentanil concentration will be achieved. Starting from 1.5 ng/ml in the first patient and increased or decreased by 0.2 ng/ml intervals based on the previous patient response: up if cough present, down otherwise (Dixon's up and down method)."
15955998|NCT03218111|Other|MR Imaging|All subjects will undergo six sessions of MR imaging over a 10-12 hour period
15955999|NCT03218111|Other|CT-guidance|All subjects will be injected, intrathecally using CT-guidance, with an MRI contrast.
15956000|NCT03218098|Procedure|Lobectomy via UVATS|lobectomy with small skin access 4 cm
15956001|NCT03218085|Drug|Tenofovir|Two cervical biopsies, blood plasma, PBMC, and two cervicovaginal swabs will be collected at a single study visit
15956002|NCT03218085|Drug|Emtricitabine|Two cervical biopsies, blood plasma, PBMC, and two cervicovaginal swabs will be collected at a single study visit
15956003|NCT03218072|Drug|HLX01|a potential rituximab biosimilar
15956006|NCT03218033|Behavioral|Social Media|
15956007|NCT03218020|Other|No intervention assigned, this is an observational study.|No intervention assigned, this is an observational study.
15956008|NCT03218007|Biological|blood samples|to evaluate expression and functionnaly activity of A2AR
15956009|NCT03217994|Drug|gel HP|gel of hygrogen peroxide for teeth bleaching
15956010|NCT03217981|Other|Sepsis protocol|Adherence to the sepsis protocol
15956011|NCT03217968|Device|Cefaly® Abortive Program device|The Cefaly® Abortive Program device is an external cranial neurostimulator designed for supraorbital neurostimulation, also known as external Trigeminal Nerve Stimulation (e-TNS).
15956012|NCT03217955|Behavioral|CBT-SA|Info has been included in arm description
15956013|NCT03217955|Behavioral|Standard Treatment|Info has been included in arm description
15956014|NCT03217942|Drug|NGF|Intramuscular injection
15956015|NCT03217929|Device|Active-taVNS|Stimulation will be performed using the Neurodyn II (Ibramed) equipment approved by the national regulatory agency (ANVISA). The following parameters will be used: 120 Hz (hertz) of frequency, 250 μs of pulse duration and 12 milliamperes of intensity for a continuous stimulation for 30 minutes. This intensity corresponds to a non-painful mild paresthesia without muscle contraction previously described and evaluated. The 25 cm² (centimeters) electrodes will be positioned over the retroauricular area. A total of 10 sessions (one session per day during 10 week-days) will be performed. Every session will be followed by an interview with a trained psychiatrist to evaluate possible adverse effects and guarantee safety issues regarding the study itself.
15956016|NCT03217929|Device|Sham-taVNS|Regarding sham protocol, the device will be turned off after 60 seconds of stimulation without the knowledge of the patient. After this initial period, the referred paresthesia seems to diminish due to nerve accommodation.
15956017|NCT03217916|Diagnostic Test|Elisa assay of podocyte glycoprotein in urine|"Biomarkers evaluated in urine specimens including podocyte glycoproteins nephrin and podocalyxin, All biomarkers were measured by ELISA. Assay information for sources of ELISA kits, standard cure range, sample dilution factors, etc.
~All assays will be performed following the manufacture's instructions. All specimens will be measured in duplicate.
~Personnel who performed the assays of analyteswere blinded to the clinical information."
15956018|NCT03217903|Diagnostic Test|Myelogram|Bone marrow aspiration after 3 cycles of Azacytidine treatment
15956019|NCT03217877|Diagnostic Test|routine stress testing|In the group of routine stress testing group, the preselected functional test (exercise ECG, nuclear stress testing, or stress echocardiography) will be performed at 9~15 months after the procedure according to the practice pattern of each participating center.
15956020|NCT03217877|Diagnostic Test|No Routine stress testing|In the group of symptom oriented stress testing group, the preselected functional test (exercise ECG, nuclear stress testing, or stress echocardiography) will be performed when chest pain or angina symptom is occured after the procedure according to the practice pattern of each participating center.
15956021|NCT03217851|Diagnostic Test|Blood Collection|blood smear and/or rapid diagnostic
15956022|NCT03217851|Diagnostic Test|Dried Blood Spot|Dried Blood Spot on filter paper
15956023|NCT03217838|Drug|AZD2811|AZD2811 will be administered by IV infusion over 2 hours for doses <= 600 mg and by IV infusion over 4 hours for doses > 600 mg. AZD2811 will be given in 28-day cycles.
15956024|NCT03217838|Drug|Azacitidine|"Azacitidine is supplied in vials of 25 mg/mL powder for suspension for injection. After reconstitution, each vial contains a maximum of 100 mg.
~Patients should be pre-medicated for nausea and vomiting according to institutional standards before receiving azacitidine. Patients will receive 75 mg/m² on Days 1 through 7 or for 5 consecutive weekdays with rest on the 2 weekend days, and azacitidine dosing the first 2 weekdays of the next week of each 28-day cycle."
15956025|NCT03217838|Drug|Venetoclax|Venetoclax (VENCLEXTA®) is approved by the FDA for use in combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly-diagnosed AML in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy. Venetoclax is planned to be given at a dose of 100 mg orally (PO) on Day 1 and 200 mg (PO) on Days 2- 28 for the 1st cycle. The third patient in cohort 1 (AZD2811 at 200 mg) will only be enrolled after the first 2 patients have received ≥2 weeks of treatment and have shown no evidence of toxicity observed to be compatible with a DLT.
15956026|NCT03217825|Drug|Rostafuroxin|This is a potent, selective and safe inhibitor of this altered mechanism and has been proved to be effective in reducing blood pressure levels in Adducin mutated rat strains and in chronic Ouabain infused rat model.
15956027|NCT03217825|Drug|Losartan|COZAAR (losartan potassium) is an angiotensin II receptor (type AT1) antagonist. Losartan potassium, a nonpeptide molecule, is chemically described as 2-butyl-4-chloro-1-[p-(o-1H-tetrazol-5-ylphenyl)benzyl]imidazole- 5-methanol monopotassium salt.
15956028|NCT03217812|Drug|Velcade|Participants will receive velcade 1.3 mg/m^2, SC injection, twice weekly at Weeks 1, 2, 4 and 5 in Cycle 1 followed by once weekly at Weeks 1, 2, 4 and 5 in Cycles 2 to 9 of Treatment Arm A and B.
15956029|NCT03217812|Drug|Melphalan|Participants will receive melphalan 9 mg/m^2 (if serum creatine is >2 mg/dL at baseline, participants must be administrated 4.5 mg/m^2 of melphalan, instead of 9 mg/m^2), orally, once daily on Days 1 to 4 of each cycle up to Cycle 9 Treatment Arm A and B.
15956030|NCT03217812|Drug|Prednisone|Participants will receive prednisone 60 mg/m^2, orally, once daily, on Days 1 to 4 of each cycle up to Cycle 9 Treatment Arm A and B.
15956031|NCT03217812|Drug|Daratumumab|Participants will receive daratumumab 16 mg/kg as IV infusion or daratumumab SC, once weekly, for 6 weeks in Cycle 1 and then once every 3 weeks, in Cycle 2 to 9 and thereafter, once every 4 weeks until documented progression, unacceptable toxicity, or the end of study in Treatment Arm B.
15956032|NCT03217799|Device|Measurement of coagulability of blood|A small pneumatic cuff is attached to the root of the index finger. The sensor cuff is attached several centimeters distal to the pneumatic cuff. Measurement is taken for a 60-second control period, and then the pneumatic cuff is inflated to above-systolic blood pressure (200 mm Hg) for 180 seconds, and measurement is taken during this period of time. The cuff is then deflated, and another 60-second measurement is taken. Data is collected by the measuring device for later analysis.
15956033|NCT03217773|Procedure|ESD|Refer to arm description
15956034|NCT03217773|Procedure|TAMIS|Refer to arm description
15956078|NCT03217487|Procedure|Limbal conjunctival autograft|A 3- to 5- clock hour limbal-conjunctival autograft will be obtained from the fellow eye. This is then ready for transplantation on the disease eye following removal of scarred and diseased epithelium.
15956035|NCT03217760|Procedure|Endodontic treatment|Endodontic treatment or root canal therapy is a sequence of treatment for the infected pulp of a tooth which results in the elimination of infection and the protection of the decontaminated tooth from future microbial invasion.
15956036|NCT03217760|Other|VAS of stress|The VAS is a 10-cm scale without graduation on which subjects are asked to score the specific level of stress experienced from 0 (not stressed at all) to 10 (worst stress imaginable)
15956037|NCT03217760|Other|CORAH scale|At the beginning of the treatment (T1), the patient is asked to complete a French version of the Corah Dental Anxiety scale (DAS).
15956038|NCT03217760|Other|HAD Scale|At the beginning of the treatment (T1), patients and students are asked to complete the Hospital Anxiety and Depression Scale (HAD Scale) which is presented as a reliable instrument for assessing clinically significant anxiety and depression.
15956039|NCT03217760|Other|Cardiovascular Parameters|For each subject, the physiological indicators of stress (ie, heart rate [HR], systolic blood pressure [SBP], and diastolic blood pressure [DBP]) are monitored during each of the 6 steps.
15956040|NCT03217760|Other|Cortisol Measurements|Salivary samples are collected during each of the 6 steps of endodontic treatment which are then stored at -20° before being sent to the laboratory to test cortisol levels .
15956041|NCT03217760|Other|Discomfort and Pain Experienced During Treatment|Patients were asked to report the levels of discomfort and pain experienced during the 6 steps using the VAS and at the next visit for the final restoration.
15956042|NCT03217760|Other|Patient's preferences.|After the completion of each treatment patients will have to report whether they thought that they would have experienced as much pain, stress, or discomfort if they had received premedication before treatment.
15956043|NCT03217760|Other|student preferences.|"When the treatment is complete the students are asked to report:
~his/her level of satisfaction with the course of treatment,
~whether he/she felt awkward faced with the patient's manifestations of stress, discomfort, or pain during the session
~whether he/she would have preferred that the patient had received sedative medication before the endodontic treatment."
15956044|NCT03217747|Biological|Anti-OX40 Antibody PF-04518600|Given IV
15956045|NCT03217747|Drug|Avelumab|Given IV
15956046|NCT03217747|Radiation|Radiation Therapy|Undergo radiation therapy
15956047|NCT03217747|Biological|Utomilumab|Given IV
15956048|NCT03217734|Biological|Adalimumab|Subcutaneous Injection
15956049|NCT03217734|Drug|Methotrexate|Oral Tablet
15956050|NCT03217734|Drug|Placebo|Oral Tablet
15956051|NCT03217708|Device|Jawbone UP4|Wrist worn wearable technology will be utilized to study HR, temperature, sleep, activity changes before and after surgery.
15956052|NCT03217695|Behavioral|Mindfulness-based Yoga Arm|
15956053|NCT03217682|Other|Music Therapy|Music therapy sessions
15956054|NCT03217682|Other|Massage Therapy|Massage therapy sessions
15956055|NCT03217669|Drug|Epacadostat|Epacadostat tablet: 100mg or 300mg
15956056|NCT03217669|Drug|sirolimus|Sirolimus tablet: 1mg, 2mg, 3mg, or 6mg
15956057|NCT03217656|Other|No intervention|
15956058|NCT03217643|Drug|Brentuximab Vedotin|The first part of the treatment (induction) will evaluate BV-CHP. The second part of the treatment (consolidation) will use standard drugs for the treatment of lymphoma. HDT will consist of BEAM conditioning regimen (or BAM if carmustine is not available). Management of HDT/ASCT will be done according to standard practice.
15956059|NCT03217630|Other|Fasting 2 h after clear liquid or 6h after a light meal|The fasting time for all patients is 2 h after clear liquid or 6h after a light meal, then gastric ultrasound examination is performed.
15956060|NCT03217617|Biological|TYF-IL-2Rg gene-modified autologous stem cells|Infusion of transduced autologous stem cells
15956061|NCT03217604|Drug|Placebo|Treatment with placebo
15956062|NCT03217604|Drug|PF-06852231|Treatment with PF-06852231
15956063|NCT03217591|Drug|IW-1973|Oral Tablet
15956064|NCT03217591|Drug|IW-1973|Oral Tablet
15956065|NCT03217591|Drug|Placebo|Oral Tablet
15956066|NCT03217578|Other|SMA Newborn Screening|
15956067|NCT03217565|Drug|IV Tedizolid Phosphate|A single dose, or twice daily dose for 3 days, of tedizolid phosphate administered IV.
15956068|NCT03217565|Drug|Oral Suspension Tedizolid Phosphate|A single dose of tedizolid phosphate administered as an oral suspension.
15956069|NCT03217552|Diagnostic Test|Mologic Biomarker Panel|In brief the proposed biomarkers will be measured in the laboratory of Mologic . These will initially be performed using standard lab assays (Enzyme Linked Immunosorbent Assays, ELISA). Biomarkers that show promise will then be mounted on a novel lateral flow device (under development), that could ultimately be deployed at the patients bedside.
15956070|NCT03217539|Diagnostic Test|Imaging|
15956071|NCT03217526|Other|Gait Training|Gait Training: Training will be applied by a physiotherapist on a treadmill or on an overgorund.
15956072|NCT03217500|Procedure|Corneal epithelial autograft|After removal of the recipient's pterygium tissue, a donor epithelial tissue equal in length to the bared limbus, will be obtained from the peripheral epithelial of the same eye (corneal epithelial autograft) using femtosecond laser technology. The epithelial graft will be sutured to the recipient limbal bed, with the goal of reconstruction of palisades of Vogt. The graft will act as a barrier to regrowth of pterygium. The area of the graft will be left with the Tenon capsule exposed.
15956073|NCT03217500|Procedure|Limbal conjunctival autograft|After removal of the recipient's pterygium tissue, an adjustable diamond knife will be used to create a superficial circumferential incision at the corneal end of the limbal vascular arcade, equal in length to the bared limbus. This will be followed by harvesting the limbal-conjunctival flap. The limbal-conjunctival autograft will be sutured to the recipient bed, with the Tenon capsule exposed. The graft will serve as a barrier to regrowth of pterygium.
15956074|NCT03217500|Procedure|Simple removal|Simple removal of the recipient's pterygium tissue, with the Tenon capsule exposed.
15956075|NCT03217500|Device|Diamond knife|A diamond knife to create a particular shaped limbal graft for transplantation
15956076|NCT03217500|Device|Femtosecond laser|A commercial femtosecond laser to create a particular shaped graft for transplantation
15956077|NCT03217487|Procedure|Corneal epithelial autograft|Epithelial tissue, equal in area to the diseased eye's cornea bed, will be obtained from the fellow eye using femtosecond laser technology. This corneal epithelial autograft is then ready for transplantation on the disease eye, following removal of scarred and diseased epithelium.
15956079|NCT03217487|Device|Femtosecond laser|A commercial femtosecond laser to create a particular shaped graft for transplantation
15956080|NCT03217487|Device|Diamond knife|A diamond knife to create a particular shaped limbal graft for transplantation
15956081|NCT03217474|Procedure|FLDEB|The eye will be anesthetized, and femtosecond laser technology will be used to remove epithelial tissue (diameter: 8mm; depth: 100micron) that includes the loosened diseased corneal epithelial cells. Antibiotic ointments and drops will be instilled postoperatively.
15956082|NCT03217474|Drug|Ganciclovir (GCV)|Patient will be treated with GCV orally (200mg, 3 times a day, for 14 days).
15956083|NCT03217474|Device|Femtosecond laser|A commercial femtosecond laser to create a particular shaped graft for transplantation.
15956084|NCT03217461|Procedure|CorneaL epithelial autograft|After removal of the recipient's diseased dermoid, a size-match donor epithelial tissue will be obtained from the healthy area of the same eye (corneal epithelial autograft) using femtosecond laser technology, with the goal of closure of bare stromal area by sutured corneal epithelial tissue to ensure the integrity of ocular surface. This closure may also create a microenvironment that stimulates stromal cells' regenerative capacity and regulates their epithelial-mesenchymal transition process.
15956085|NCT03217461|Device|Femtosecond laser|A commercial femtosecond laser to create a particular shaped graft for transplantation
15956086|NCT03217461|Procedure|Limbal autograft|Simple dermoid excision will be performed, followed by closure of the bare sclera by sutured femtosecond laser-assisted limbal autograft.
15956087|NCT03217461|Device|Femtosecond laser|A commercial femtosecond laser to create a particular shaped graft for transplantation
15956088|NCT03217448|Drug|Dabigatran etexilate|Subjects should take Dabigatran etexilate 150mg twice a day for 6 months after randomization.
15956089|NCT03217448|Drug|Warfarin|Subjects should take Warfarin for 6 months after randomization and the dose will be changed according to investigator's judgment.
15956090|NCT03217435|Procedure|Corneal epithelial allograft|A living-related donor's epithelial flap, equal in area to the recipient's diseased cornea bed, will be created using femtosecond laser technology. This corneal epithelial allograft is then ready for transplantation on the recipient's disease eye, following removal of the recipient's scarred and diseased epithelium.
15956091|NCT03217435|Procedure|Limbal conjunctival allograft|A 3- to 5- clock hour limbal-conjunctival allograft will be obtained from the living-related eye. This is then ready for transplantation on the recipient's disease eye following removal of the recipient's scarred and diseased epithelium.
15956092|NCT03217435|Device|Femtosecond laser|A commercial femtosecond laser to create a particular shaped graft for transplantation
15956093|NCT03217435|Device|Diamond knife|A diamond knife to create a particular shaped limbal graft for transplantation
15956096|NCT03217409|Drug|Rosuvastatin+Ezetimibe|Rosuvastatin 5mg+Ezetimibe 10mg
15956097|NCT03217409|Drug|Rosuvastatin|Rosuvastatin 5Mg Tablet
15956098|NCT03217396|Procedure|lumbar puncture|lumbar puncture performed to detect OCB for diagnostic purposes
15956099|NCT03217383|Device|MATRx plus|The MATRx plus test is a 2- or 3-night home sleep test that uses temporary titration trays to move the lower jaw in response to respiratory events. The purpose of the test is to predict oral appliance therapy outcome, and to provide a protrusive position for individuals predicted to experience therapeutic success.
15956100|NCT03217370|Other|education of guidelines|"Guidelines will be updated and education will be given to haematologists in several ways.
~ICT implementations: a) last result of haemoglobin and platelet count will be shown on the electronic blood order; b) an electronical clinical decision support system will be implemented to order blood components"
15956101|NCT03217357|Device|Transcranial stimulation in direct current|tDCS (2mA, 30 minutes with the anode at the left DLPFC and the cathode at the right DLPFC) active or placebo
15956102|NCT03217344|Procedure|conservative treatment|immobilization on sling of the injured arm
15956103|NCT03217331|Drug|CRD-102|14 mg CRD-102 capsules administered twice daily orally for 14 days.
15956104|NCT03217318|Device|ureteral stenting with standard or modified ureteral stent|Ureteral stenting because of kidney and or ureteral stones at the iliacal vessel crossing of the ureter or proximally
15956105|NCT03217305|Device|NAVA|Neurally Adjusted Ventilatory Assist is a fairly new ventilation mode
15956106|NCT03217292|Procedure|Serratus Anterior Plane Block|
15956107|NCT03217292|Drug|IV patient-controlled analgesia (PCA) tramadol|
15956108|NCT03217266|Drug|MDM2 Inhibitor KRT-232|Given PO
15956109|NCT03217266|Radiation|Radiation Therapy|Undergo radiation therapy
15956110|NCT03217253|Other|Laboratory Biomarker Analysis|Correlative studies
15956111|NCT03217253|Other|Pharmacological Study|Correlative studies
15956112|NCT03217253|Drug|Tazemetostat|Given PO
15956113|NCT03217240|Procedure|Cardiac Magnetic Resonance - MRI|All participants will have to undergo CMR which uses interaction of the magnetic properties of body tissues with strong magnetic fields to create images. Participants will be asked to lie on a narrow bed placed inside of a large magnet for about 1 hour. Several sets of images are needed. Participants are required to stay very still and follow the instruction of the MRI technologist who operates the machine from a room next door.
15956114|NCT03217240|Other|Cardiopulmonary Exercise Test|Participants will be asked to undergo a cardiopulmonary exercise test (CPET). Participants will need to wear a mask. Several electrodes will be placed on the chest to record heart activity during exercise. Participants will need to pedal for at least 8-12 minutes. Pedalling will be instructed to report any symptoms such as chest discomfort, shortness of breath, leg fatigue or dizziness. A small probe will be placed on participant's finger during the test to measure the oxygen content in the blood. Immediately after exercising, participants will rest for 5-10 minutes while the blood pressure and electrocardiogram are monitored. The results will be read by a cardiologist.
15956115|NCT03217240|Other|Blood Sampling for all participants|Serum samples will be obtained before CMR. The sample will be stored at -80 degree until assay. Investigators will perform various tests related to participants heart function
15956116|NCT03217227|Other|Cardiovascular Magnetic Resonance Imaging with Exercise Bike|A rest scan is performed and a gadolinium contrast may be administered during the scan (depending on the kidney function). After the rest scan is completed, images of the subject's heart during exercise via cycling in the supine position, will be scanned.
15956117|NCT03217227|Procedure|Cardiac Catheterization|"It is a procedure to diagnose and treat cardiovascular diseases by inserting a long and thin tube known as a catheter into the artery or vein in the neck, groin or arm and threaded through the blood vessels to the heart.
~A coronary angiogram is also performed during the procedure where an invisible contrast dye (only visible in the X-rays) is injected through the catheter and X-ray images scanned will show the flow of the dye through the heart arteries to determine any blockages in the arteries.
~In the case where there is severe narrowings, fractional flow reserve (FFR) may be performed to measure the pressure in the coronary arteries.
~If there is no significant narrowing lesions, the interventionist may perform additional flow resistance measurements of the small vessels to further investigate the cause of angina"
15956118|NCT03217227|Other|Retinal Photography (Optional)|The test studies the structure and function of the eye vessels. It involves using eye drops to dilate the pupils, allowing the retinal photographer to have a better view of the back of the eye.
15956119|NCT03217227|Diagnostic Test|I123 MIBG Scintigraphy (Optional)|"The test studies the cardiac sympathetic signalling that may help to identify patients with high risks of adverse events. The scan consists of 2 acquisitions of images 3-4 hours apart.
~For this study, only patients without clinically significant lesions (diagnosed via the cardiac catetherisation and have normal FFR results) will undergo this test."
15956120|NCT03217214|Diagnostic Test|Thermography|Passive thermography for Phase I subjects and Active Thermography for Phase II subjects
15956121|NCT03217201|Device|Light Glasses (Experimental)|The light glasses emit light from LEDs at a distance of 15 millimeters (15mm, 0.015.) from the eye. The device Is classified as safe for the eyes in accordance with the international standard IEC 62471 and complies with the United States of America's FCC marking, and is designed to be worn on the participant's head, similarly to a pair of glasses. For safety purposes, the light glasses do not contain UV or infra-red light.
15956122|NCT03217201|Device|Light Glasses (Comparison)|The light glasses emit light from LEDs at a distance of 15 millimeters (15mm, 0.015.) from the eye. The device Is classified as safe for the eyes in accordance with the international standard IEC 62471 and complies with the United States of America's FCC marking, and is designed to be worn on the participant's head, similarly to a pair of glasses. For safety purposes, the light glasses do not contain UV or infra-red light.
15956123|NCT03217188|Radiation|conventionally fractionated full dose re-irradiation|re-irradiation [60-70 Gy (RBE) in 2 Gy (RBE) fractions
15956124|NCT03217188|Radiation|hypofractionated palliative re-irradiation|"course or a hypofractionated palliative re-irradiation Quad Shot course (3.7 Gy (RBE) twice daily x 2 days, followed by a 4 week break [+/- 2 weeks], repeated up to 4 cycles)."
15956125|NCT03217175|Device|Bihormonal Bionic Pancreas|The glucagon pump will be filled with glucagon during the exercise visit
15956126|NCT03217175|Device|Insulin Only Bionic Pancreas|The glucagon pump will be filled with placebo during the exercise visit, and the bionic pancreas will operate in an insulin only mode.
15956127|NCT03217175|Drug|Glucagon|Glucagon will be given according to the algorithm in the bihormonal bionic pancreas
15956128|NCT03217175|Drug|Placebo|Placebo will be given instead of glucagon according to the algorithm in the insulin-only bionic pancreas
15956129|NCT03217162|Drug|surfactant combined with mechanical ventilation (MV)|surfactant combined with mechanical ventilation (MV) is given to the infant with ARDS
15956130|NCT03217162|Drug|mechanical ventilation (MV)|mechanical ventilation (MV) is given to the infant with ARDS
15956131|NCT03217149|Drug|heliox combined with MV|heliox combined with MV is given to infant with ARDS
15956132|NCT03217149|Drug|MV|MV is given to infant with ARDS
15956133|NCT03217136|Drug|Ceftolozane|Ceftolozane 20 mg/kg (maximum 1 g) administered IV every 8 hours for between 5 to 14 day.
15956134|NCT03217136|Drug|Tazobactam|Tazobactam 10 mg/kg (maximum 0.5 g/dose) administered IV every 8 hours for between 5 to 14 days.
15956135|NCT03217136|Drug|Metronidazole|Metronidazole 10 mg/kg (maximum 1.5 g/day) administered IV every 8 hours for between 5 to 14 days. Participants =< 28 days old, start with a loading dose of 15 mg/kg; then if =< 2 kg are dosed 7.5 mg/kg/ every 12 hours; or if > 2 kg are dosed 10 mg/kg every 8 hours.
15956136|NCT03217136|Drug|Meropenem|Meropenem 20 mg/kg (maximum 1 g/dose) administered IV every 8 hours for between 5 to 14 days. At the investigator's discretion, some participants may receive meropenem up to 30 mg/kg.
15956137|NCT03217136|Drug|Placebo for Metronidazole|Placebo for Metronidazole administered IV every 8 hours for between 5 to 14 days.
15956138|NCT03217123|Device|Deep Brain stimulation|Electrical stimulation at subcortical level
15956139|NCT03217110|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|Subjects with neuropsychiatric diagnoses and matched-controls will be receive theta frequency stimulation of the cerebellum. We will target the cerebellar vermis.
15956140|NCT03217110|Device|Sham Repetitive Transcranial Magnetic Stimulation (rTMS)|Subjects with neuropsychiatric diagnoses and matched-controls will be receive sham stimulation of the cerebellum. We will target the cerebellar vermis.
15956141|NCT03217097|Drug|Oxaliplatin-based chemotherapy|"The oxaliplatin-based group will receive gemox (gemcitabine-oxaliplatin, 1x/2 week); alternatively folfox (5 fluorouracil-leucovorin-oxaliplatin, 1x/2 week) or capox (capecitabine-oxaliplatin, 1x/3 week)."
15956142|NCT03217097|Drug|Alkylating-based chemotherapy|"The alkylating-based group will receive CapTem regimen (capecitabine and temozolomide, /4 week), alternatively LV5FU2 (folinic acid-5 fluorouracil)-dacarbazine (1x/2 week) or LV5FU2 (folinic acid-5-fluorouracil)-streptozotocine (1x/2 week)."
15956143|NCT03217084|Drug|MI varnish GC|MI Varnish GC is a 5% sodium fluoride varnish that has a desensitizing action when applied to tooth surfaces. MI Varnish also contains RECALDENT. Open the unit-dose package of Varnish. Use the applicator brush to thoroughly mix Varnish. Apply Varnish evenly in a thin layer over treatment area(s). For larger surface areas, apply Varnish in sweeping horizontal brush. After application, instruct the patient to close his or her mouth to set the Varnish. No need to use suction. The patient may feel the thin coating when rubbing the treated area with his or her tongue. The treatment period for Varnish is minimally 4 hour.
15956176|NCT03216863|Other|Respiratory rehabilitation|It consists of a global care of the patient: therapeutic education, nutritional maintenance, psychological support and re-training to the effort at home after discharge or after follow up visit of targeted therapy
15956177|NCT03216850|Device|Sublingual microcirculation assessment|Non-invasive investigation of the endothelial glycocalyx in the sublingual microcirculation.
15956144|NCT03217084|Drug|White varnish 3M|White varnish 3M is a 5% sodium fluoride varnish that has a desensitizing action when applied to tooth surfaces. Clinpro White Varnish contains an innovative tri-calcium phosphate.Open the unit-dose package of Varnish and dispense the entire content onto the round application guide provided with the packet. Use the applicator brush to thoroughly mix Varnish. Apply Varnish evenly in a thin layer over treatment area(s). For larger surface areas, apply Varnish in sweeping horizontal brush. After application, instruct the patient to close his or her mouth to set the Varnish. No need to use suction. The patient may feel the thin coating when rubbing the treated area with his or her tongue. The treatment period for Varnish is minimally 4 hour.
15956145|NCT03217071|Drug|Pembrolizumab|All study participants will receive pembrolizumab every 3 weeks, for 2 cycles.
15956146|NCT03217071|Radiation|stereotactic radiation therapy (SRT)|Patients in Cohort 2 of the Safety run-in and patients in the expansion cohort who are randomized to the 'pembrolizumab +radiation arm' will receive one dose of SRT within 1 week (+/- 3 days) following the second administration of pembrolizumab.
15956147|NCT03217058|Behavioral|Clinic-based screening and behavioral interventions|As part of routine HIV primary care visits, patients will complete self-administered computerized substance use, anxiety and depression screening measures. Results will be integrated into the electronic health record. A behavioral health specialist on the clinic staff will contact patients who screen positive for high-risk substance use, anxiety or depression, and offer behavioral interventions including motivational interviewing and cognitive behavioral therapy.
15956148|NCT03217045|Other|nutrition protocol introduction|Growth comparison of 2 cohorts of infants evaluated in a before-after design
15956149|NCT03217032|Biological|YUVA-GT-F801|Lentiviral factor VIII gene modified autologous hematopoeitic stem cells and mesenchymal stem cells
15956150|NCT03217019|Procedure|Guidewire-assist|catheter insertion with guidewire-assist(catheter over guidewire)
15956151|NCT03217019|Procedure|Direct|catheter insertion without guidewire assist(catheter over needle)
15956152|NCT03217006|Procedure|Single arterial graft|This interventions consists of patients receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. In addition to the left internal thoracic artery patients will receive venous grafts for all additional grafting.
15956153|NCT03217006|Procedure|Multiple arterial grafting|This intervention consists of the patient receiving the left internal thoracic artery to the left anterior descending coronary artery of the heart. The second arterial graft (right internal thoracic artery or radial artery) will be directed to the major branch of the circumflex. Additional grafts will include saphenous veins or arterial conduits.
15956154|NCT03216993|Other|Standard care|Standard care: patients receive enteral nutrition in accordance with the usual practice in the participating units
15956155|NCT03216993|Other|Protocol care|Protocol care： patient receive enteral nutrition in accordance with enteral nutrition protocol studied
15956156|NCT03216980|Dietary Supplement|PTSD/GAD Antioxidant|Subjects will ingest an antioxidant cocktail containing 800 milligrams of alpha lipoic acid, 1 gram of vitamin C (ascorbic acid), and 400 milligrams of vitamin E (alpha tocopherol).
15956157|NCT03216980|Dietary Supplement|PTSD/GAD Placebo|Subjects will ingest placebo (microcrystalline cellulose) pills.
15956158|NCT03216980|Dietary Supplement|Healthy Control Antioxidant|Subjects will ingest an antioxidant cocktail containing 800 milligrams of alpha lipoic acid, 1 gram of vitamin C (ascorbic acid), and 400 milligrams of vitamin E (alpha tocopherol).
15956159|NCT03216980|Dietary Supplement|Healthy Control Placebo|Subjects will ingest placebo (microcrystalline cellulose) pills.
15956160|NCT03216967|Drug|everolimus|Patients with viremia above 3 log of copies/ml will be randomized (ratio 1:1) into either of 2 groups Group 1 : control group : immunosuppression lowering or Group 2 : experimental group : immunosuppression lowering and replacement of mycophenolate acid by everolimus Evolution of BKV viremia and allograft function will be assessed during 2 years after randomization
15956161|NCT03216954|Drug|Alcohol|During each arm, subjects will receive doses of alcohol, designed to raise BALs to 0.015 and 0.03 g/dl.
15956162|NCT03216954|Drug|Placebos|Subjects will receive placebo capsules
15956163|NCT03216954|Drug|N-acetyl cysteine|Subjects will receive n-acetyl cysteine capsules
15956164|NCT03216941|Drug|Ketamine|"study medications were packaged in identical color-coded boxes. first dosage included either 10 mg of olanzapine, or 10 mg of ketamine Dosages were chosen based on previous studies After the initial dose, no additional dosis were allowed if supplemental medication eas needed according to clinician judgment the subject will be immediately removed from the study.
~All subjects will be assessed 1 hour, 2 hours, 4 hours, 6 hours and 12 hours after t he first administration of the medication."
15956165|NCT03216928|Diagnostic Test|Blood test|
15956166|NCT03216915|Drug|Gilenya®; Novartis Pharmaceuticals Corporation|This is a prospective cohort-based study. Eligible are all patients planned for a treatment with fingolimod at the Hamburg University Hospital who are willing and able to participate in an observational study.
15956167|NCT03216902|Drug|Vehicle of DE-126 Ophthalmic Solution, high dose of DE-126 Ophthalmic Solution|Vehicle of DE-126 Ophthalmic Solution dosed once daily for 6weeks, followed by high dose of DE-126 dosed once daily for 6 additional weeks
15956168|NCT03216902|Drug|Topical ultra-low dose of DE-126 Ophthalmic Solution|Topical ultra-low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
15956169|NCT03216902|Drug|Topical low dose of DE-126 Ophthalmic Solution|Topical low dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
15956170|NCT03216902|Drug|Topical medium dose of DE-126 Ophthalmic Solution|Topical medium dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
15956171|NCT03216902|Drug|Topical high dose of DE-126 Ophthalmic Solution|Topical high dose of DE-126 Ophthalmic Solution dosed once daily for 12 weeks
15956172|NCT03216902|Drug|0.005% Latanoprost Ophthalmic Solution|0.005% Latanoprost Ophthalmic Solution dosed once daily for 12 weeks
15956173|NCT03216889|Behavioral|Cognitive Behavioral Therapy for Insomnia|Involves attending 1 hour long sessions weekly for 6 weeks. Sessions will be one-on-one or in a group.
15956174|NCT03216889|Behavioral|Control|Involves attending 1 hour long sessions weekly for 6 weeks. Sessions will involve stretching and thinking games.
15956175|NCT03216876|Drug|Ursolic acid|Ursolic acid (UA) is a natural triterpenoid carboxylic acid, which has been studied for its anti-proliferative and anti-inflammatory activities.
15956496|NCT03214406|Drug|Crest Cavity Protection Regular Toothpaste (Negative Control)|Negative control
15956178|NCT03216837|Device|Cathodal transcranial direct current stimulation|The primary intervention will be cathodal (inhibitory) tDCS over the contralesional M1. Soft, replaceable 25cm2 electrodes (Soterix, NYC) will be placed on clean, dry areas of the scalp. The cathode will be placed over the contralesional M1, precisely mapped for each patient using neuronavigated (Brainsight2, Rogue Research, Montreal QU) MRI-TMS co-registration over the hotspot for the contralateral first dorsal interosseous muscle. The current-controlled model stimulator (Soterix, NYC) will automatically ramp up slowly over 30 seconds to the treatment current of 1.0 milliamp. tDCS will be administered each day during the first 30 minutes of the daily 1:1 therapy sessions.
15956179|NCT03216837|Device|Sham transcranial direct current stimulation|Soft, replaceable 25cm2 electrodes (Soterix, NYC) will be placed on clean, dry areas of the scalp. The cathode will be placed over the contralesional M1, precisely mapped for each patient using neuronavigated (Brainsight2, Rogue Research, Montreal QU) MRI-TMS co-registration over the hotspot for the contralateral first dorsal interosseous muscle.The current-controlled model stimulator (Soterix, NYC) will automatically ramp up slowly over 30 seconds to the treatment current of 1.0 milliamp and then ramp down over 30 seconds to 0 milliamps. Sham will be administered each day during the first 30 minutes of the daily 1:1 therapy sessions.
15956180|NCT03216824|Other|Dressing|A dressing is maintained on the CVAD exit site.
15956181|NCT03216824|Other|No-Dressing|The CVAD exit site is not covered with a dressing.
15956182|NCT03216811|Drug|nutraceutical|8-week administration of nutraceutical compound
15956183|NCT03216798|Other|questionnaires survey|The questionnaires will be self-administered and anonymous. Information obtained from the questionnaire will not contain identifiable information of patients, CBO staff or health care workers.
15956184|NCT03216772|Device|Olympus PK Morcellator in PneumoLiner|Laparoscopic Supracervical Hysterectomy (LSH) or Total Laparoscopic Hysterectomy (TLH) using Olympus PK Morcellator in PneumoLiner containment device
15956185|NCT03216759|Procedure|Ischemic preconditioning|After the anesthesia induction and before surgery,the patient's left upper limb was subjected to ischemic preconditioning then patients received ischemic preconditioning.
15956186|NCT03216759|Drug|Dexmedetomidine|At the beginning of anesthesia induction, 3 ug/kg/h of dexmedetomidine was infused and adjusted to 0.3 ug/kg/h after 10 min of infusion until 30 minutes before the end of the procedure.
15956187|NCT03216759|Procedure|Patient-controlled epidural analgesia|Before the induction of anesthesia, the steel wire epidural catheter was placed in the T8-9 or T10-11 gap.The first volume of morphine 2mg + 0.2% ropivacaine + 0.9% saline 6ml, maintenance dose of morphine 18mg + 0.1% ropivacaine + 0.9% saline total 150ml. PCEA work with a continuous background dose of 2 ml/h with a single dose of 2ml/time, load 2ml, locking time 15min.
15956188|NCT03216746|Behavioral|Oral orientation and App for smartphone|66 adolescents aged between 14 and 19 years. Participants enrolled in this group received standardized oral guidance performed by one of the previously trained researchers and included aspects of general and oral health and, in particular, of periodontal diseases. This intervention was carried out in a classroom, in a group with approximately 20 participants, providing an environment of discussions about the subjects covered. The duration was approximately 15 minutes. The participants also received an App for smartphone containing messages of reinforcement in oral health which was sent during a period of 30 days.
15956189|NCT03216746|Behavioral|Oral orientation|71 adolescents aged between 14 and 19 years. Participants enrolled in this group received standardized oral guidance performed by one of the previously trained researchers and included aspects of general and oral health and, in particular, of periodontal diseases. This intervention was carried out in a classroom, in a group with approximately 20 participants, providing an environment of discussions about the subjects covered. The duration was approximately 15 minutes.
15956190|NCT03216746|Behavioral|Video orientation and App for smartphone|63 adolescentes aged between 14 and 19 years. Participants enrolled in this group received oral health information through an audiovisual material produced especially to this research to offer a teaching medium capable of arousing the attention of its audience. The elaboration counted with the participation of three actors, two acting as adolescents and the third as a dental surgeon. The video had a total duration of 14 minutes. The participants also received an App for smartphone containing messages of reinforcement in oral health which was sent during a period of 30 days.
15956191|NCT03216746|Behavioral|Video orientation|63 adolescentes aged between 14 and 19 years. Participants enrolled in this group received oral health information through an audiovisual material produced especially to this research to offer a teaching medium capable of arousing the attention of its audience. The elaboration counted with the participation of three actors, two acting as adolescents and the third as a dental surgeon. The video had a total duration of 14 minutes.
15956192|NCT03216733|Device|COMBO|PCI with COMBO stent
15956193|NCT03216733|Device|ORSIRO|PCI with ORSIRO stent
15956194|NCT03216720|Procedure|CABG|"Cannulation: 24-F arterial cannula, 29/29 F dual-stage venous cannula, and aortic root vent-/cardioplegia cannula
~Grafting: pedicled left internal mammary artery, and no-touch
~saphenous vein graft Heparin and protamine doses assessed by HMS Plus® Hemostasis Management System
~Target activated coagulation time of >400 seconds"
15956195|NCT03216720|Procedure|Miniaturized extracorporeal circulation|"Centrifugal pump to reduce mechanical stress
~Circuit coated with biosurface to increase haemocompatibilty.
~Ante- and retrograde autologous priming and low-volume cardioplegia solution (intermittend cold modified Calafiore) to minimize haemodilution
~Collapsible soft-shell reservoir for blood volume management
~Cell-saving device
~Venous air removing device and electric clamp system to air embolism"
15956196|NCT03216720|Procedure|Conventional extracorporeal circulation|"Roller pump
~Circuit uncoated
~Hard-shell venous reservoir
~Intermittend cold blood Harefield cardioplegia"
15956197|NCT03216707|Device|HD tDCS active motor cortex|the intervention will be 10 participants will be subjected to 1.5-gram of Capsaicin cream 0.075 concentration for 30 min then participants will be subjected to active stimulation targeting motor cortex area with the high-definition transcranial direct current stimulation device with current intensity 2 milliampere for 20 min
15956198|NCT03216707|Device|HD tDCS active insula cortex|the intervention will be 10 participants will be subjected to 1.5 gram of Capsaicin cream 0.075 concentration for 30 min then participants will be subjected to active stimulation targeting Insular cortex area with the high-definition transcranial direct current stimulation device, with current intensity 2milliampere for 20 min
15956246|NCT03216356|Drug|Study Pill|250 mg DCS (derived from Seromycin 250 mg capsules) or polyethylene glycol 3350 powder
15956199|NCT03216707|Device|HD tDCS sham motor cortex|the intervention 10 participants will be subjected to1.5 gram of Capsaicin cream 0.075% concentration for 30 min then participants will be subjected to sham stimulation targeting motor cortex area using the high-definition transcranial direct current stimulation device by starting stimulation for 30 seconds then stop stimulation for 20 min
15956200|NCT03216707|Other|Capsaicin cream|Capsaicin cream
15956201|NCT03216694|Diagnostic Test|Cardiopulmonary exercise testing|Aerobic fitness measured using a cycle ergometer and metabolic cart
15956202|NCT03216681|Drug|Hoat Huyet Nhat Nhat|Administered orally twice a day, 2 tablets each time, for 45 days.
15956203|NCT03216681|Drug|Tanakan 40mg|Administered orally three times a day, 1 tablet each time, for 45 days.
15956204|NCT03216668|Drug|TONKA|Administered orally twice a day, 2 tablets each time, for 6 weeks.
15956205|NCT03216668|Drug|LEGALON|Administered orally three times a day, two tablets each time, for 6 weeks
15956206|NCT03216655|Other|phone call|Investigators give a regular follow-up to participants: phone call monthly
15956207|NCT03216655|Other|wechat group|Investigators give a regular follow-up to participants: wechat follow up. Investigators send useful information and answer their questions monthly.
15956208|NCT03216642|Diagnostic Test|bacterial culture and analysis|Specimens were collected with soft-tipped applicators of sterile cotton swabs after syphilis of lacrimal passages.
15956209|NCT03216629|Behavioral|"Saying sorry"|"The objective of this study is to investigate how empathy expressed in form of saying sorry affect the perception of pain during dressing change?"
15956210|NCT03216616|Behavioral|Cognitive Behavioural Therapy|
15956211|NCT03216603|Behavioral|Health literacy intervention group|In the health literacy intervention group all patients will receive self-management help using a motivating interviewing (MI) technique delivered by two MI and COPD trained nurses once a week for eight weeks after hospitalization. Subsequently, the contact between the patients and the nurses will be by follow up motivational telephone calls once a month or more if needed for four months (i.a a total of six months intervention period).
15956212|NCT03216590|Device|Compressive draping using adhesive incise drape|In the intervention group the shoulder will be drape with compressive draping using adhesive incise drape (Ioban™2 Antimicrobial Incise Drape, 3M Inc.,USA).
15956213|NCT03216577|Other|Phone interview measuring health-related quality of life variables|A phone interview will be conducted by a dedicated nurse who will be blinded to the exposed/non-exposed status of the patient.
15956214|NCT03216564|Drug|Calcitriol|Active vitamin D (Calcitriol) 0.25 micrograms
15956215|NCT03216551|Diagnostic Test|Intra-operative frozen section|Tumor histologic subtypes (whether it is lepidic predominant adenocarcinoma), N1 nodes metastasis (lymph nodes adjacent to the tumor will be sent to frozen section) and visceral pleural invasion will be determined by the intra-operative frozen section.
15956216|NCT03216538|Drug|AS101 1% oral solution|0.4 ml daily p.o.
15956217|NCT03216538|Drug|Placebo|0.4 ml daily p.o.
15956218|NCT03216525|Drug|Alvimopan|To determine if Alvimopan during radical cystectomy with urinary diversion results in faster return of bowel function.
15956219|NCT03216525|Drug|Placebo|To determine if placebo during radical cystectomy with urinary diversion results in faster return of bowel function.
15956220|NCT03216512|Other|Use of Noise Cancelling Headphones|During the 2 experimental sessions, participants will complete study assessments using either a noise cancelling headphone first (session 1) and then sham control second ( session 2), or vice versa, in the presence of noise distractions.
15956221|NCT03216499|Drug|HIF-2alpha Inhibitor PT2385|Given PO
15956222|NCT03216499|Other|Pharmacological Study|Correlative studies
15956223|NCT03216499|Other|Laboratory Biomarker Analysis|Correlative studies
15956224|NCT03216499|Other|Pharmacogenomic Study|Correlative studies
15956225|NCT03216486|Drug|BPS804|IV administration of BPS804 in 5% Dextrose solution
15956226|NCT03216473|Drug|Neuronox|Clostridium Botulinum Toxin A 100 U
15956227|NCT03216473|Drug|Botox|Clostridium Botulinum Toxin A 100 U
15956228|NCT03216460|Device|Insulet automated glucose control system|Insulet AP (artificial pancreas) system, using the Omnipod® insulin management system, Dexcom G4Share® AP System and personalized model predictive control algorithm.
15956229|NCT03216447|Drug|Advagraf|Tacrolimus prolonged-release hard capsules (QD)
15956230|NCT03216447|Drug|Prograf|Tacolimus capsules (q12h)
15956231|NCT03216434|Diagnostic Test|MRI using DaTscan|"A standard, non-contrast-enhanced structural/anatomic brain MRI will be performed. It will be used to exclude potential subjects and controls with significant and potentially confounding structural/anatomic findings. It will also be used as an anatomic overlay with the functional DaTscan image to aid in anatomic/physiologic correlation. At the same imaging session, a brief functional MRI (not requiring the subject to perform any tasks) will also be performed."
15956232|NCT03216421|Other|Quality of Life Questionnaires|Quality of Life questionnaires will be completed by each subject.
15956233|NCT03216408|Drug|Neuronox|
15956234|NCT03216408|Drug|Botox|
15956235|NCT03216395|Device|Over-the-scope Clips|Over-the-scope Clips is mounted onto a transparent cap, which is attached to the tip of the endoscope. To deploy the claw device, a cogwheel at the scope head is turned pulling a trip string. This in turn retracts the cap releasing the OTSC onto tissue.
15956236|NCT03216395|Device|Hemo-clipping|Hemo-clipping <=20 clips
15956237|NCT03216395|Device|thermo-coagulation|contact thermo-coagulation < = 8 pulses
15956238|NCT03216395|Drug|Epinephrine|epinephrine injection (diluted 1:1000) beneath peptic ulcer <20 mls
15956239|NCT03216382|Behavioral|Attention Training Technique|The ATT is a 12-minute audio recording that includes sounds and a voice guiding attention to the sounds. The sounds play continuously during the training task.
15956240|NCT03216382|Behavioral|Control Condition|In the control condition, participants listen to an audio recording with the same sounds as the ATT recording, and a voice that delivers placebo instructions.
15956241|NCT03216369|Other|MRI|MRI perfusion imaging
15956242|NCT03216356|Behavioral|CBT + ImRs|Cognitive Behavioral Therapy with Imagery Rescripting
15956243|NCT03216356|Behavioral|CBT + I.E.|Cognitive Behavioral Therapy with Imagery Exposure
15956244|NCT03216356|Drug|D-Cycloserine|250 mg DCS (derived from Seromycin 250 mg capsules)
15956245|NCT03216356|Drug|Placebo|polyethylene glycol 3350 powder
15956248|NCT03216330|Other|No Intervention|There is no treatment intervention. We are assigning measurement tools such as the Electronic Thimble Algometer for QST and questionnaires to both groups.
15956249|NCT03216317|Behavioral|Intervention Group|Isometric handgrip training consisting of four series
15956250|NCT03216304|Drug|100 mg safinamide|"Safinamide will be administered as follows:
~Days 5-11: 100 mg safinamide (one Xadago® tablet), once a day
~Day 12: a single dose of 100 mg safinamide (one Xadago® tablet), immediately followed by a single dose of 20 mg rosuvastatin calcium (one Crestor® tablet)
~Days 13-15: 100 mg safinamide (one Xadago® tablet) once a day The medication will be orally administered in the morning, at 8:00±1h, under fasting conditions, with 240 mL (total volume) of still mineral water."
15956251|NCT03216304|Drug|20 mg rosuvastatin calcium period 1|"Rosuvastatin will be administered as follows:
~- Day 1: a single dose of 20 mg rosuvastatin calcium (one Crestor® tablet)"
15956252|NCT03216304|Drug|20 mg rosuvastatin calcium period 2|- Day 12: a single dose of 20 mg rosuvastatin calcium (one Crestor® tablet) immediately after the safinamide administration
15956253|NCT03216291|Behavioral|biofeedback therapy|Biofeedback therapy is a labor-intensive, multi-disciplinary, team approach for the management of patients with anorectal problems. Complete training sessions once a week for 6 weeks in the office.
15956254|NCT03216291|Device|Home Biofeedback therapy|Biofeedback therapy is a labor-intensive, multi-disciplinary, team approach for the management of patients with anorectal problems, but instead of an office therapy, the subject will use a biofeedback device to gain strength in their anorectal muscles. This device will be taught how to use in the first session and then the subject will take it home to complete at least 1 session a day for 6 weeks.
15956255|NCT03216278|Drug|Dapagliflozin/metformin XR 5/500mg|Tablets for oral administration, once daily, once per treatment period
15956256|NCT03216278|Drug|Dapagliflozin/metformin XR 5/500 mg|Tablets for oral administration, once daily, once per treatment period
15956257|NCT03216278|Drug|Dapagliflozin/metformin XR 5/500mg|Tablets for oral administration, once daily, once per treatment period
15956258|NCT03216278|Drug|Dapagliflozin/metformin XR 5/500mg|Tablets for oral administration, once daily, once per treatment period
15956259|NCT03216278|Drug|Dapagliflozin/metformin XR 10/1000mg|Tablets for oral administration, once daily, once per treatment period
15956260|NCT03216278|Drug|Dapagliflozin/metformin XR 10/1000mg|Tablets for oral administration, once daily, once per treatment period
15956261|NCT03216278|Drug|Dapagliflozin/metformin XR 10/1000mg|Tablets for oral administration, once daily, once per treatment period
15956262|NCT03216278|Drug|Dapagliflozin/metformin XR 10/1000mg|Tablets for oral administration, once daily, once per treatment period
15956263|NCT03216265|Other|Test product (Moisturising cream)|Participants will be instructed to apply their assigned product to the randomly assigned sites twice daily (in the morning and evening).
15956264|NCT03216265|Other|Positive control (Commercial market place moisturising cream)|Participants will be instructed to apply their assigned product to the randomly assigned sites twice daily (in the morning and evening).
15956265|NCT03216265|Other|No treatment|No treatment.
15956266|NCT03216252|Biological|samples|Blood samples, oral smear and urine
15956267|NCT03216226|Drug|dasiglucagon|Glucagon Analog
15956268|NCT03216226|Drug|GlucaGen|Native Glucagon
15956269|NCT03216213|Other|Frame|Vignette is framed in a way that nudges participant to leave a legacy
15956270|NCT03216213|Other|Norms|Vignette informs the participant that most people choose an option to try to nudge participant into choosing that option as well
15956271|NCT03216200|Device|plasma treatment|application of cold atmospheric plasma to a fungal infected toenail
15956274|NCT03216174|Procedure|NESS-EFTR|NESS-EFTR includes steps of laparoscopic seromuscular suturing, EFTR of the inverted stomach wall, and endoscopic mucosal suturing with endoloops and clips.
15956275|NCT03216148|Diagnostic Test|FET-PET|All participating patients will receive a FET PET-scan parallel to the routine MRI at the end of the first line therapy (restaging) according to the HIT-protocol Second FET PET: In case of suspected tumour recurrence or progression within the follow-up period of 24 (12) months, the participating patient will receive a second FET PET-scan (parallel to an MRI)
15956276|NCT03216122|Procedure|Conventional/Delayed Loading|
15956277|NCT03216122|Procedure|Immediate Loading|
15956279|NCT03216096|Drug|Placebo ophthalmic solution and 3% DE-089 ophthalmic solution|Placebo ophthalmic solution; 1 drop, 6 times daily (every 2-3 hours) instilled into both eyes for 2-week run-in period 3% DE-089 ophthalmic solution; ; 1 drop, 6 times daily (every 2-3 hours) instilled into both eyes for 4-week treatment period
15956280|NCT03216083|Drug|Tranexamic Acid Injectable Solution|1g IV tranexamic acid mixed in normal saline (67mL)
15956281|NCT03216083|Other|Placebo|67mL IV normal saline
15956282|NCT03216070|Drug|Dasatinib 50 MG|50mg of dasatinib orally daily
15956283|NCT03216057|Dietary Supplement|Omega-3 fatty acid 3 grams per day|Each capsule contains 400 mg of eicosapentaenoic acid and 200 mg of docosahexaenoic acid. We allocated five capsules per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 2000 mg of eicosapentaenoic acid and 1000 mg of docosahexaenoic acid per day (3 gr of Omega 3 per day) by mouth for 12 weeks. The trademark is Omega RX Dr.Sears Zone labs Inc.
15956284|NCT03216057|Dietary Supplement|Placebo|Placebo Comparator: Placebo Each capsule contains 600 mg of soybean oil. We allocated five capusles per day, three in the morning and two at night, every 12 hours (8.00 am and 8:00 pm), therefore the subject ingest 3000 mg of soybean oil per day (3 gr soya oil per day) by mouth for 12 weeks.
15956285|NCT03216031|Behavioral|Gardening programme|3 groups with up to 10 patients and 2-4 students/staff members each should meet once per week for about 1 hour to engage in gardening activities at the falls prevention growing site. Each participant will attend the programme 8 times.
15956286|NCT03216018|Behavioral|"Prevention program: In Favor of Resilient Self"|"Prevention program: In Favor of Resilient Self"
15956287|NCT03216005|Device|BlueLeaf System|The BlueLeaf System will be used to create an autogenous leaflet to mimic valve function.
15956288|NCT03215992|Device|Diffuse Optical Tomography (DOT) System|Diffuse optical tomography (DOT) is a novel imaging modality that uses low-intensity, near-infrared light to characterize tissue. As light of a specific wavelength travels through tissue, it is absorbed and scattered by different chromophores and cellular structures. Using four wavelengths of light allows the detection of four chromophores: oxyhemoglobin, deoxyhemoglobin, water and fat.
15956289|NCT03215979|Procedure|Platelet enriched plasma administration|It is a blinded administration of platelet enriched plasma in the temporal fascia used to cover the auricular reconstruction frame, during the second stage of the procedure. The use of platelet enriched plasma is focused to improve the integration rate of the full-thickness split skin graft
15956290|NCT03215979|Procedure|Placebo Arm|5 ml of saline 0.9%will be applied in the temporal fascia as a placebo used to compare to the experimental group.
15956291|NCT03215966|Combination Product|Macitentan / tadalafil FDC|Tablets for oral administration containing 10 mg of macitentan and 40 mg of tadalafil
15956292|NCT03215966|Drug|Macitentan (Opsumit®)|Film-coated tablets for oral administration formulated at a strength of 10 mg
15956293|NCT03215966|Drug|Tadalafil (Adcirca®)|Film-coated tablets for oral administration formulated at a strength of 20 mg
15956294|NCT03215953|Device|cast shoe|ankle-high, custom-made, well-moulded cast shoe
15956295|NCT03215953|Device|removable walker|Prefabricated especially designed for relieving load on the foot
15956296|NCT03215940|Drug|Delta-9-Tetrahydrocannabinol|An oral dose of Delta-9-Tetrahydrocannabinol (THC) will be given once a day for five day with pain ratings taken before and after each dose every day.
15956297|NCT03215940|Drug|Cannabidiol|An oral dose of Cannabidiol (CBD) will be given once a day for five day with pain ratings taken before and after each dose every day.
15956298|NCT03215940|Drug|Placebos|An oral placebo will be given once a day for five day with pain ratings taken before and after each dose every day.
15956299|NCT03215927|Drug|Abatacept|Abatacept 125mg subcutaneous weekly
15956300|NCT03215927|Other|Placebo|Placebo
15956301|NCT03215914|Device|MiniMed 670G system|Eligible subjects with type 1 diabetes will initiate hybrid closed-loop insulin delivery based on interstitial glucose monitoring via the MiniMed 670G system according to Medtronic's labeling. This system combines subject-delivered pre-meal boluses with automatic interprandial insulin delivery that includes automated functions for both predictive and threshold suspension of insulin delivery intended to minimize exposure to glucose levels < 70 mg/dl.
15956302|NCT03215901|Behavioral|A Beautiful Future Video|Video delivering information on the longevity gains due to HIV treatment in the area.
15956303|NCT03215901|Behavioral|Active Control Video|Video on another topic.
15956304|NCT03215888|Procedure|bariatric surgery|Obese patients will undergo brain imaging, neurocognitive function testing and measurement of insulin resistance and inflammatory markers pre- and post bariatric surgery
15956305|NCT03215875|Drug|Fed- 60mg ER Torsemide|60mg ER Torsemide will be given after high fat, high-calorie meal
15956306|NCT03215875|Drug|Fasting- 60mg ER Torsemide|60mg ER Torsemide will be given after overnight fasting
15956307|NCT03215862|Drug|Lactated Ringer|This is a Lactated Ringer's solution infusion before, during, and after the ERCP procedure.
15956308|NCT03215862|Drug|Normal Saline 0.9% Infusion Solution Bag|This is a Normal Saline solution infusion before, during, and after the ERCP procedure.
15956309|NCT03215849|Device|CRT-pacemaker device set to Routine Medical Therapy|Medtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy
15956310|NCT03215849|Device|CRT-pacemaker device set to Routine Medical Therapy + LVP|Medtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy + LVP
15956311|NCT03215849|Device|CRT-pacemaker device set to Routine Medical Therapy + BiVP|Medtronic Serena™ QUAD CRT-P MRI™ SureScan™ W4TR05 set to Routine Medical Therapy + BiVP
15956312|NCT03215836|Procedure|Bronchoscopy and Nasal Epithelium Brush Sampling|After meeting screening criteria, participants will undergo further evaluation to determine whether or not inclusion and exclusion criteria are met. Participants will undergo a baseline evaluation, lung function testing and a subsequent bronchoscopy and nasal epithelial brush sampling in those that meet study enrollment.
15956313|NCT03215810|Procedure|Tumor-infiltrating Lymphocytes (TIL)|Tumor harvest for TIL growth in the lab: A sample of the participant's tumor will be collected and sent to the lab for TIL growth. TIL will be prepared and cryopreserved.
15956314|NCT03215810|Drug|Nivolumab|Nivolumab will be administered intravenously at a fixed dose of 240 mg for 4 doses every 2 weeks prior to TIL. Nivolumab dose will be fixed at 480 mg every 4 weeks up to 12 months after TIL.
15956315|NCT03215810|Drug|Cyclophosphamide|Cyclophosphamide will be administered at 60 mg/kg/day IV in 250 mL normal saline (NS) over approximately 2 hours. Cyclophosphamide will be initiated seven days prior to the anticipated TIL transfer, and the precise timing will depend on the rate of in vitro TIL growth. The dose will be based on the patient's body weight, but to prevent undue toxicity, it will not exceed a dose greater than 140% of the maximum ideal body weight per Metropolitan Life Insurance Company, Height and Weight Table.
15956316|NCT03215810|Drug|Fludarabine|After administration of Cyclophosphamide, Fludarabine will then be infused at 25 mg/m^2 intravenous piggyback (IVPB) daily over approximately 30 minutes starting 5 days prior to TIL transfer. To prevent undue toxicity with fludarabine, the dose will be based on body surface area (BSA), but will not exceed a dose calculated on surface areas based on body weights greater than 140% of the maximum ideal body weight per Metropolitan Life Insurance Company Height and Weight Tables.
15956317|NCT03215810|Other|Tumor-infiltrating Lymphocyte Therapy|On day 0, all patients will receive TIL administered according to the current Moffitt Cell Therapy TIL Standard Operating Procedure (SOP). Eight (8) to twelve (12) hours after completing the TIL infusion, all participants will begin intermediate-dose decrescendo interleukin-2 (IL-2).
15956318|NCT03215810|Drug|Interleukin-2 (IL2)|Interleukin-2 (IL-2) - a drug used to help the body's response to treatment on the immune system. A high dose regimen of IL-2 will be given after the infusion of the T-cells.
15956319|NCT03215797|Drug|phenylephrine|phenylephrine 100ug/ml IV infusion at a rate of 5ml/h in case of hypotension.
15956320|NCT03215797|Drug|Norepinephrine|Norepinephrine 5ug/ml IV infusion at a rate of 5 ml/h in case of hypotension
15956321|NCT03215784|Dietary Supplement|Fish Oil|
15956322|NCT03215784|Dietary Supplement|Probiotic|
15956323|NCT03215784|Dietary Supplement|Placebo|
15956324|NCT03215771|Device|MyoPro Motion-G|The MyoPro Motion-G is an elbow-wrist-hand myoelectric orthosis.
15956325|NCT03215771|Other|Motor Learning-Based Therapy|Motor learning-based (MLB) therapy included movement practice as close to normal as possible, high repetition, progression of challenge, part versus whole task practice, and knowledge of results. Treatment was customized to abilities of each subject and consisted of both MyoPro training and MLB therapy without device. Training with device was progressed using a hierarchy of challenge to increase complexity of movement. MLB therapy without device followed the same hierarchy, incorporating training of movements that could not be accomplished with the device and those that were trained with device. Movement quality was monitored and training practice was incrementally progressed as subject demonstrated improved ability to perform a given task/movement component. Subjects performed a custom home exercise program (HEP) on non-clinic days, increasing repetition as tolerated. At conclusion of in-clinic phase, individuals transitioned to a home phase where they continued to use the HEP.
15956326|NCT03215758|Drug|QAW039|QAW039 once daily
15956327|NCT03215758|Drug|Placebo|Placebo once daily
15956328|NCT03215745|Behavioral|Delirium prevention program|Delirium prevention program Placard with the names of the care team and the calendar days; cognitively stimulating activities three times a day. Pictures, radio, robe. Visual aids large print books, with daily reinforcement of use Maintain adequate lighting opening blinds and curtains during the day, and darken their environment at night. Dissipation wax and special techniques of communication, with daily reinforcement of these adaptations. Go to the patient by name and tone of voice appropriate. Always listen. Use simple and clear language, face-to-face. Avoid excessive familiarity and childish. Promote family involvement in self-care and caregivers and the reorientation of the patient, contact with extended family during the stay.
15956329|NCT03215732|Diagnostic Test|HBV testing with dried blood spots (DBS) technique|Survey participants will be tested at home for chronic HBV infection using the DBS technique (collection of drops of whole blood dried onto filter paper).
15956330|NCT03215719|Radiation|Standard Radiation Treatment|An interval scan at 4 weeks to assess for a good response defined as >40% nodal shrinkage will stratify patients into receiving standard treatment (≤40% nodal shrinkage) or a dose-deescalated treatment regimen (>40% nodal shrinkage).
15956331|NCT03215719|Radiation|Dose-Deescalated Treatment|Intensity-modulated radiation therapy (IMRT) is an advanced type of radiation therapy used to treat cancer and noncancerous tumors. IMRT uses advanced technology to manipulate photon and proton beams of radiation to conform to the shape of a tumor. Patients will be treated with intensity-modulated radiation therapy (IMRT) with megavoltage photons
15956332|NCT03215719|Drug|Cisplatinum|Standard of care chemotherapy
15956333|NCT03215706|Biological|Ipilimumab|Specified dose on specified day
15956334|NCT03215706|Biological|Nivolumab|Specified dose on specified day
15956335|NCT03215706|Drug|Carboplatin|Specified dose on specified day
15956336|NCT03215706|Drug|Paclitaxel|Specified dose on specified day
15956337|NCT03215706|Drug|Pemetrexed|Specified dose on specified day
15956338|NCT03215706|Drug|Cisplatin|Specified dose on specified day
15956339|NCT03215693|Drug|X-396 capsule|225mg once daily
15956340|NCT03215680|Other|Climate|Hot and temperate climate
15956341|NCT03215667|Device|easy-graft CLASSIC (beta-Tricalcium Phosphate)|easy-graft will be grafted to a single extraction socket and covered by polylactide membrane to facilitate regeneration of new bone in order to preserve alveolar ridge dimensions.
15956342|NCT03215654|Other|"EspaiJove.net mental health literacy program"|"The EspaiJove.net: a space for mental health (EspaiJove.net) project is a MHL program which aims the promotion of mental health, the prevention of mental disorders, the facilitation of help-seeking behaviors and the eradication of stigma among secoundary students into the Spanish context."
15956343|NCT03215641|Device|Fitbit|The Fitbit is a consumer-grade personal activity tracker. It is used to track physical activity. Patients will be given devices at the beginning of the study, and they will continue to use it for 7 weeks. Their data will be collected on a weekly basis, and patients will receive feedback on their level of activity based on the Fitbit data.
15956344|NCT03215628|Diagnostic Test|TCEUS|Intravenous sulphur hexafluoride microbubbles
15956345|NCT03215615|Procedure|Periodontal surgery|Coronally advanced flap for root coverage
15956346|NCT03215615|Procedure|Total Etch adhesive|Total-etch adhesive system (two step)
15956347|NCT03215615|Procedure|Universal Adhesive|One-step self-etching adhesive system
15956348|NCT03215615|Procedure|Nanofilled Composite|Partial nanofilled-resin composite restoration
15956349|NCT03215615|Procedure|Micro-Hybrid Composite|Partial micro-hybrid composite restoration
15956350|NCT03215602|Other|NEMEX and education + strength training|Optimizing sensorimotor control and achieving functional stability. Increasing knee extensor muscle strength. Teaching everyday disease management.
15956351|NCT03215602|Other|NEMEX and education|Optimizing sensorimotor control and achieving functional stability. Teaching everyday disease management.
15956352|NCT03215563|Radiation|18F PET-MRI|18F-fluoride Hybrid PET-MRI
15956353|NCT03215563|Diagnostic Test|Transcranial Doppler|Microembolic Signals detection
15956354|NCT03215550|Procedure|CEA|Carotid Endarterectomy
15956355|NCT03215550|Radiation|18F PET-MRI|18F-fluoride Hybrid PET-MRI
15956356|NCT03215550|Diagnostic Test|Transcranial Doppler|Microembolic Signals detection
15956357|NCT03215537|Behavioral|comprehensive intervention|preoperative and postoperative exercise program
15956358|NCT03215524|Biological|DCdP|Daratumumab, Cyclophosphamide, Dexamethasone, Pomalidomide
15956359|NCT03215524|Biological|DCd+P|Daratumumab, Cyclophosphamide, Dexamethasone, + Pomalidomide added only at first confirmed biochemical progression
15956360|NCT03215511|Drug|Selitrectinib (BAY2731954)|Selitrectinib is administered as capsules or liquid formulation.
15956361|NCT03215498|Drug|Faster-acting insulin aspart|In a euglycaemic clamp setting each participant will receive a priming dose of 0.08 U/kg body weight, followed by a continuous basal rate of 0.02 U/kg body weight/h and finally a bolus dose of 0.15 U/kg body weight on top of the basal rate
15956362|NCT03215498|Drug|Insulin aspart|In a euglycaemic clamp setting each participant will receive a priming dose of 0.08 U/kg body weight, followed by a continuous basal rate of 0.02 U/kg body weight/h and finally a bolus dose of 0.15 U/kg body weight on top of the basal rate
15956363|NCT03215485|Behavioral|Nutrition lessons|Face-to-face interactive group lessons delivered in the classroom.
15956364|NCT03215485|Behavioral|Virtual world learning environment|Every participant has their own unique avatar in the virtual world learning environment named Rippleville. They can choose to complete quests, watch archived nutrition video lessons, explore, and socialize with other avatars. They receive rewards (Rippleville dollar and badges) for their efforts.
15956365|NCT03215485|Other|Newsletter|All participants in the intervention and comparison groups receive up to 10 professional newsletters on topics related to sports nutrition and performance, healthy eating and active living tips.
15956366|NCT03215472|Other|DASH Cloud|With DASH Cloud, the investigators will ask participants to track their diet daily using a commercial diet tracking app. The investigators will retrieve the diet data on our DASH Cloud platform and provide tailored feedback about a participant's DASH adherence via fully automated daily or weekly text messages. These feedback messages will describe both an individual's absolute performance and change over time. The investigators also include theory-driven tailored content that reinforces successes, offers motivational strategies, and offers short behavior change tips.
15956367|NCT03215472|Other|Nutritionix Track app|DASH Light Control participants will be asked to use the Nutritionix app daily and receive publicly available written materials on the DASH diet.
15956368|NCT03215459|Device|Cardiopulmonary Exercise Test|Cardiopulmonary Exercise Test
15956369|NCT03215446|Drug|maintenance of anaesthesia with propofol|
15956370|NCT03215446|Drug|maintenance of anaesthesia with sevoflurane|
15956371|NCT03215420|Diagnostic Test|MRI 3T|
15956372|NCT03215407|Drug|Intra-articular Tocilizumab|Patients will be randomly chosen to be intra-articular injected of tocilizumab injection
15956373|NCT03215407|Drug|Intra-articular Compound Betamethasone|Patients will be randomly chosen to be intra-articular injected of compound betamethasone injection
15956374|NCT03215394|Behavioral|Attention Training Program|The attention training involves 8 visits over 4 weeks with pre/post data collection before and after the training, and a follow-up 6 months later. Pre/post data collection involves the ESCS and a Laboratory Temperament Assessment Battery (LabTAB), and a series of on-screen assessment tasks that measure cognitive control, distraction tolerance, sustained attention, habituation, gap-overlap, disengagement, and attention to static images. Training runs from Wk 2-5 with 2 visits per week and is completed in home with the child sitting on the parents lap in front of a monitor. The parent and child are inside a tent to reduce environmental stimuli. The research trainer is outside the tent running the program from a laptop. The program consists of a battery of 9 gaze-contingent training tasks using custom MATLAB scripts. The animated tasks are designed to engage the child and present as developmentally appropriate games. At each visit 6 of the 9 tasks will run for a total of 4min each(24min).
15956375|NCT03215394|Behavioral|Social ABCs|The 6-month Social ABCs parent-mediated intervention consists of 12 weeks of parent training and a 12 week implementation phase. 15 training (parent coaching) sessions are provided by a Research Trainer. Each session with the trainer includes a review of the program manual, practice of the techniques in the child's home, and a 15 min video of the parent-child dyad practicing the intervention. Week 9 and 11 are phone consultations. After the active training is complete, the parent enters the 12-week implementation phase, which includes practicing the techniques on their own, with no trainer instruction or contact. The trainer re-visits the parent and child at Week 24 to collect three 15 min videos; 2 generalization videos are also taken with an untrained examiner.
15956376|NCT03215394|Other|Treatment As Usual|The Treatment as Usual group acts as a pre-existing convenience sample, consisting of families currently enrolled in a different approved research study run by the same group of investigators. Children in this group have comparable clinical concerns for ASD, and complete the same standardized measures (ADOS, MSEL, ESCS, AOSI) as the Baseline assessment in this RCT, but will not receive Social ABCs or the Attention Training Program. They are able to access any programs or interventions available to them in the general community. This is tracked on a Services Log form, included as part of that study's protocol. Families in this group will have consented to their child's data being shared across studies in this research group.
15956377|NCT03215394|Behavioral|Sham Attention Training|The sham attention condition will use identical hardware, administered by the same research staff for the same frequency and duration as the attention training program (8 visits over 4 weeks including pre/post data collection). In this condition, infants will be exposed to non-gaze contingent visual stimuli that offer no adaptive difficulty levels (ie. clips of age appropriate television shows). Placebo stimuli will be presented until toddlers become fidgety or distressed.
15956378|NCT03215381|Drug|[11C]AZD1390|[11C]AZD1390
15956379|NCT03215355|Drug|Primovist|"Primovist is currently a drug marketed for MRI. In this study it will be administered intravenously at 4 times what it is quoted for MRI to enhance the different imaging modality (CBCT) to improve the accuracy of liver SBRT. Although liver SBRT usually consists of 5 treatments, contrast will only be administered during the first treatment.
~Consulting Health Canada and Bayer HealthCare Canada (the drug manufacturer) deemed this use off label dosing which in Canada is at the discretion of the physician. Based on preliminary imaging testing, and a review of toxicity literature for this drug, the administration for this specific use was deemed appropriate to give adequate image quality, while simultaneously maintaining patient safety."
15956380|NCT03215342|Behavioral|Pediatric Goal Management Training|7 GMT modules will be administered in 7x2 hours sessions (ten groups). Manualized intervention; metacognitive strategies for improving attention and problem solving. Homework assignments between sessions.
15956381|NCT03215342|Behavioral|Pediatric Brain Health Workshop|7 pBHW modules will be administered in 7x2 hours sessions (ten groups). Psychoeducation; brain (dys)function, plasticity, memory, executive function, and attention. Stress, physical exercise, sleep, nutrition, and energy management. Homework assignments between sessions
15956382|NCT03215329|Procedure|abdominal or vascular surgery|Intermediate or high risk abdominal or vascular surgery
15956449|NCT03214653|Drug|Propofol|Subjects were given target-controlled infusion of propofol using Schinder technique effect mode with the administration of maintenance agent was adjusted by the depth of sedation using bispectral index monitor with target of 45-50
15956497|NCT03214393|Diagnostic Test|Doppler|Doppler will be done to pregnant women with Pre-Eclampsia
15956383|NCT03215303|Device|Continuous Positive Airway Pressure (CPAP)|In the first moment, CPAP will be installed, and the researcher will hold a mask in the position in which it is coherent, explaining the method to the patient and allowing their gradual adaptation. Patients will adapt for a few minutes to make sure the mask is consistent with the specifications, so that the patient is comfortable. Participants in the intervention group will start with a PEEP of 1cmH2O that will increase by 2 cmH2O until a PEEP of 10 cmH2O is reached. Therefore, participants in the intervention group will remain with CPAP, PEEP of 10cmH2O, FiO2 0.21, for a period of 40 minutes.
15956384|NCT03215290|Procedure|TCS|"The cutting surface recognized as not good cutting surface was further trans-parenchymal compressing sutured, if possible, using a hepatic needle."
15956385|NCT03215277|Drug|Bimekizumab|One bimekizumab dose will be administered.
15956386|NCT03215277|Drug|Certolizumab pegol|Two certolizumab pegol doses will be administered. One of these doses is a loading dose.
15956387|NCT03215277|Other|Placebo|Placebo will be provided to maintain the blinding.
15956388|NCT03215264|Drug|hydroxychloroquine|160mg daily
15956389|NCT03215264|Drug|entinostat|2-5mg weekly
15956390|NCT03215264|Drug|regorafenib|400-1200mg daily
15956391|NCT03215251|Other|Intervention bundle|Assessment of the patient's mouth and lips determined, to check any stickiness or dryness in the mouth or around lips or split skin at the corners of the mouth or cracked lips. Intervention bundle consisted of sterile cold wet oral swab wipes and sterile ice cold water sprays administered for in two sessions of 15 minutes each. First session was given in 15 minutes, patients received cold wet oral swab wipes in oral cavity 2 to 3 times and mouth spray with 5 to 6 sprays. A maximum of 9 wipes and 18 sprays of sterile water. After administration of intervention bundle, Posttest 1 was taken after 15 minutes observation with the same tools. Then researcher waited for 15 minutes after post test1 and session two was administered in 15 minutes with a maximum of 9 wipes and 18 sprays of sterile water. Post test 2 was taken after 15 minutes of session two.
15956392|NCT03215225|Procedure|Root canal orthograde treatment|
15956393|NCT03215212|Other|eye mask|eye mask administered from 10 pm to 7 am
15956394|NCT03215212|Other|ocean sound|Ocean sound administered via ear phone for 30 minutes from 9:15 pm to 9:45 pm
15956395|NCT03215212|Other|ear plug|ear plug administered from 10 pm to 7 am
15956396|NCT03215199|Other|NAPT|Web-based depression and distress monitoring application
15956397|NCT03215186|Other|observational study|
15956398|NCT03215173|Behavioral|Fit After Baby|Mobile application
15956399|NCT03215173|Behavioral|Text4Baby Control Group|Receive free text messages
15956400|NCT03215160|Behavioral|Exercises|mobilization exercises (Patellofemoral joint, Tibiofemoral joint, Soft tissue) and classical exercises performed in the early post-op period
15956401|NCT03215147|Diagnostic Test|Confirmation of Airway Disease combined with IPF|To confirm the airway disease combined with IPF, PFT+BDR+DLCO, MBPT, Induced sputum exam, MAST, Total IgE, serum Eosinophil count, FENO will be done at the time of registration and 6~8 weeks later.
15956402|NCT03215134|Other|Self-criticism intervention|Compassion Focused Therapy (Gilbert, 2010) adapted to focus specifically on reducing self-criticism. This intervention was originally developed for a student population (Rose, McIntyre & Rimes, submitted) and is now being evaluated in a primary mental-health service.
15956403|NCT03215121|Procedure|One handed mask airway, switch to two hands|"Prior to the induction of anesthesia, a shoulder role will be used to have the child's head in sniffing position for induction. Horizontal alignment of the external auditory meatus with the sternum, will be used as a marker for, proper positioning.
~Oxygen and nitrous oxide for 10-15 seconds will be administered and sevoflurane will then be commenced.The provider will hold the mask as randomized, one hand mask airway with switch to two hand for Group 1 patients. Any changes in airway patency when mask is held by one hand versus two hands will be observed and documented by various parameters. The initial mask management will be performed for 20 seconds.
~After another 20 seconds (50 seconds from the start of induction), in Group one, the mask holding will switch to two hands for 20 seconds."
15956404|NCT03215121|Procedure|Two handed mask airway + jaw thrust|"Prior to the induction of anesthesia, a shoulder role will be used to have the child's head in sniffing position for induction. Horizontal alignment of the external auditory meatus with the sternum, will be used as a marker for, proper positioning.
~Oxygen and nitrous oxide for 10-15 seconds will be administered and sevoflurane will then be commenced.The provider will hold the mask as randomized, two hands for Group two patients. Any changes in airway patency when mask is held by one hand versus two hands will be observed and documented by various parameters. In Group 2 patient's mask will be held with two hands first for 40 seconds."
15956405|NCT03215121|Procedure|Two handed mask airway, switch to one hand|"Prior to the induction of anesthesia, a shoulder role will be used to have the child's head in sniffing position for induction. Horizontal alignment of the external auditory meatus with the sternum, will be used as a marker for, proper positioning.
~Oxygen and nitrous oxide for 10-15 seconds will be administered and sevoflurane will then be commenced.The provider will hold the mask as randomized, two hands for Group 3 patients. Any changes in airway patency when mask is held by one hand versus two hands will be observed and documented by various parameters. The initial mask management will be performed for 20 seconds.
~After another 20 seconds (50 seconds from the start of induction), in Group 3, the mask holding will switch to one hand for 20 seconds."
15956406|NCT03215108|Device|Endoscopic Retrograde CholangioPancreatography(ERCP)|This study is prospective randomized multicenter study by using Endoscopic Retrograde CholangioPancreatography(ERCP). Comparison between Novel flower-type covered stent and Conventional covered stent in malignant extrahepatic biliary obstruction will be conducted after stent insertion by using Endoscopic Retrograde CholangioPancreatography(ERCP).
15956407|NCT03215095|Drug|Durvalumab (Medi4736)|durvalumab 1500 mg IV every 4 weeks
15956408|NCT03215095|Radiation|Radioiodine (RAI)|100 mCi (+/- 10 mCi) of 131I will be administered a day after Thyrogen injections have been administered for two consecutive calendar days.
15956409|NCT03215082|Other|Vestibular-Visual Intervention|vestibular-visual exercises
15956410|NCT03215082|Behavioral|standard care|standard care
15956411|NCT03215069|Drug|Empagliflozin 10 MG|Empagliflozin 10 mg PO daily
15956412|NCT03215069|Drug|Placebo oral capsule|Placebo PO daily
15956413|NCT03215056|Drug|Methoxyflurane|PENTHROX 3mL inhalation vapour, liquid
15956414|NCT03215056|Drug|Normal saline|Placebo
15956415|NCT03215043|Dietary Supplement|Eriocitrin|The selected individuals will be randomly distributed in 4 groups through random number generator program. Group A (n = 20) will receive a dose of 140 mg / d eriocitrin; Group B (n = 20) eriocitrin 280 mg / d; The C group (n = 20) 560 mg / d eriocitrin; And group D (n = 20) will receive the placebo with corn starch excipient. All doses will be packaged in Manipulation Pharmacy, and should be of the same type, color and size. Individuals will be instructed to regularly ingest a pre-dinner capsule for 12 weeks.
15956416|NCT03215043|Other|Placebo|The selected individuals will be randomly distributed in 4 groups through random number generator program. Group A (n = 20) will receive a dose of 140 mg / d eriocitrin; Group B (n = 20) eriocitrin 280 mg / d; The C group (n = 20) 560 mg / d eriocitrin; And group D (n = 20) will receive the placebo with corn starch excipient. All doses will be packaged in Manipulation Pharmacy, and should be of the same type, color and size. Individuals will be instructed to regularly ingest a pre-dinner capsule for 12 weeks.
15956419|NCT03215017|Device|Transanal irrigation|Effect of Transanal irrigation (TAI) using Peristeen® anal irrigation system - Coloplast
15956420|NCT03215017|Drug|Medication|Medication to help control of the bowel movement (One or a combination of Loperamide, Sorbitol, Sterculia gum)
15956421|NCT03214965|Behavioral|Facebook group|A closed facebook group used to deliver multimedia content specifically produced to inform the participants about chronic kidney disease, kidney transplantation and related topics. This group is also used to share doubts and life experiences among participants and the interdisciplinary team.
15956422|NCT03214952|Drug|Vonoprazan|Vonoprazan tablets
15956423|NCT03214939|Biological|Immunotherapy based on dendritic cells|Intravenous injection of cells
15956424|NCT03214926|Device|Moving Through Glass intervention|
15956425|NCT03214913|Other|Early Goal Directed Therapy|EGDT therapy ：30ml/kg in the first bolus to have a CVP 8-12 mmHg and MAP 65-85 mm Hg,and urine output ≥0.5 ml/kg/h, ScvO2 ≤70%；If not, use noradrenine，red blood cell transfusion if necessary.
15956426|NCT03214913|Other|Ruijin Strategy|"Ruijin Strategy：10~5ml/kg/h，crystalloid vs colloid 2:1 resuscitation;using noradrenaline at the same time;red blood cell transfusion if necessary.
~target： fulfillment of two or more of four criteria:1. HR <120 beats/min, 2.MAP 65-85 mm Hg, 3. urine output ≥1 ml/kg /h 4. HCT 25%~35%."
15956427|NCT03214887|Biological|RV-P1501|Gel-like product with BMMNCs in each ml of hyaluronan (HA) solution
15956428|NCT03214874|Drug|Demadex 20mg Tablet|Immediate Release (IR) Torsemide
15956429|NCT03214874|Drug|ER Torsemide 20mg Tablet|Extended Release Torsemide 20 mg tablet given once daily
15956430|NCT03214861|Other|Carbohydrate quality|This is an observational study examining the association between carbohydrate quality and coronary heart disease. The investigators used a variety of carbohydrate quality metrics to evaluate carbohydrate quality including carbohydrate, starch, total fiber, cereal fiber, fruit fiber, and vegetable fiber intakes, and the ratios of carbohydrate to total fiber, carbohydrate to cereal fiber, starch to total fiber, and starch to cereal fiber intakes.
15956431|NCT03214848|Behavioral|Contraceptive education prior to abortion|Contraceptive education script will be delivered over the phone prior to abortion visit.
15956432|NCT03214835|Device|Endo CDx Brush biopsy|In patients with laryngeal lesion the brush biopsy will be taken with the standard cup biopsy - either in the clinic or in the OR. In LPR patients brush biopsy will be taken in the clinic.
15956433|NCT03214822|Dietary Supplement|H2MF|As described in the Experimental Arm description.
15956434|NCT03214809|Diagnostic Test|ultrasound protocol|after first assessment and treatment by the MET team, an Multi-organ ultrasound protocol will be run by the MET doctor
15956435|NCT03214796|Drug|Human albumin|Infusion of human albumin
15956436|NCT03214783|Other|Facial characteristics|The exposures are facial characteristics which differ significantly in exposure rates between coronary artery disease (CAD) group and no CAD group.
15956437|NCT03214770|Drug|TheraCal|Biomaterial used for carious lesions reaching to dentin. Material is applied and after 6 month dentin sample collection and the bacterial count by digital colony counter, Agar diffusion test.
15956438|NCT03214770|Drug|light-cured calcium hydroxide|Biomaterial used for carious lesions reaching to dentin. Material is applied and after 6 month dentin sample collection and the bacterial count by digital colony counter, Agar diffusion test.
15956439|NCT03214757|Other|treatment of anemia.|drug treatment of anemia.
15956440|NCT03214731|Drug|Artesunate|Artesunate was produced by pharmaceutical factory for research specifically
15956441|NCT03214731|Other|placebo|placebo was produced by pharmaceutical factory for research specifically
15956442|NCT03214718|Diagnostic Test|Measurement level of myeloid derived suppressor cells in CML patients treated with imatinibe 400 mg/day|"For each patient these investigation will be done:
~- Complete blood count,bone marrow aspirate and bone marrow biopsy Measure BCR-ABL GENE Level by FISH at diagnosis and every 3 months till one year .
~Measurement Level of myeloid derived suppressor cells both granulocytic and monocytic cells by flowcytometry ."
15956443|NCT03214718|Diagnostic Test|Measurement level of myeloid derived suppressor cells in CML patients treated with nilotinib 600 mg/day|"For each patient these investigation will be done:
~- Complete blood count,bone marrow aspirate and bone marrow biopsy Measure BCR-ABL GENE Level by FISH at diagnosis and every 3 months till one year .
~Measurement Level of myeloid derived suppressor cells both granulocytic and monocytic cells by flowcytometry ."
15956444|NCT03214692|Dietary Supplement|Gum Arabic|Oral intake of GA in powder from30 grams per day
15956445|NCT03214679|Other|Accessible Care|Accessible Care will be provided by co-locating a hepatitis treatment provider, together with a Hepatitis C Care Coordinator, on-site at our collaborating needle exchange program.
15956446|NCT03214679|Other|Usual Care|Usual care entails referral to an on site HCV care coordinator (not provided by study)
15956447|NCT03214666|Drug|GTB-3550 TriKE® Phase I|"The 1st two patients will be assigned Dose Level 1. The study statistician will assign each new cohort of 2 patients to the most appropriate dose level based on updated toxicity probabilities.
~Dose Level 1 - 5 μg/kg/day
~Dose Level 2 - 10 μg/kg/day
~Dose Level 3 - 25 μg/kg/day
~Dose Level 4 - 50 μg/kg/day
~Dose Level 5 - 100 μg/kg/day
~Dose Level 6 - 150 μg/kg/day
~Dose Level 7 - 200 μg/kg/day"
15956448|NCT03214666|Drug|GTB-3550 TriKE® Phase II|Patients will receive the maximum tolerated dose (MTD) established during Phase I with monitoring guidelines to stop the study early for excessive toxicity.
15956450|NCT03214653|Drug|Sevoflurane|Subjects were given sevoflurane 1,5-2% as maintenance agent of anesthesia.
15956451|NCT03214640|Device|Rivanna Accuro US Device|When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Rivanna Accuro U/S device. For subjects in group C-R or L-R, the needle insertion site will be the site identified by the Rivanna Accuro U/S device. After placement of spinal for Cesarean or epidural for labor, the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.
15956452|NCT03214640|Other|Palpation|When the subject is ready for neuraxial procedure, the location for the epidural or spinal needle insertion will be identified with Palpation method using conventional landmarks (spinous process and iliac crest). For subjects in group C-P or L-P, the needle insertion site will be the site identified by the Palpation method. After placement of spinal for Cesarean or epidural for labor, the usual standard dose of medication will be administered as in usual manner for patients regardless in this study or not.
15956453|NCT03214640|Procedure|Neuraxial Analgesia|Labor analgesia will be provided utilizing the standard medications to provide labor analgesia
15956454|NCT03214640|Procedure|Spinal Block|Spinal anesthetic medications will be utilized in providing surgical block for cesarean delivery as is standard of care
15956455|NCT03214627|Device|Anemia Control Model (ACM)|The ACM is mainly composed of 2 sub-Systems - predictor model which, depending on the input data, forecasts the response to anaemia drug therapy for a specific patient. The predictor model is implemented as a feed-forward artificial neural network. The ACM is an algorithm that extracts the optimal policy to achieve the established clinical outcome for anaemia management using the predictor model.
15956456|NCT03214627|Drug|IV iron|IV iron given monthly as required - dose determined by the ACM and as agreed by the investigator
15956457|NCT03214627|Drug|Erythropoiesis-Stimulating Agent (ESA)|ESA given monthly as required over 6 months - dose determined by the ACM and as agreed by the investigator
15956458|NCT03214614|Drug|GLPG2451 multiple dose|GLPG2451 oral suspension, multiple ascending doses, daily for 14 days
15956459|NCT03214614|Drug|Placebo multiple dose|Placebo, oral suspension, daily for 14 days
15956460|NCT03214614|Drug|GLPG2451/GLPG2222 multiple dose|GLPG2451 oral suspension and GLPG2222 oral suspension, multiple doses, daily for 14 days
15956461|NCT03214614|Drug|Combined Placebo multiple dose|Combined Placebo, oral suspension, daily for 14 days
15956462|NCT03214601|Device|penetrating atherosclerotic ulcer, aorta branch cardiovascular implant|The Relay Branch System is intended to provide an option for patients with arch and proximal descending chronic thoracic aortic pathologies.
15956463|NCT03214588|Drug|TAK-831|TAK-831 tablets
15956464|NCT03214588|Drug|TAK-831 Placebo|TAK-831 placebo matching tablets
15956465|NCT03214575|Device|Conventional method|
15956466|NCT03214575|Procedure|GPS Method|
15956467|NCT03214562|Drug|Cytarabine|Given IV
15956468|NCT03214562|Biological|Filgrastim|Given SC
15956469|NCT03214562|Drug|Fludarabine|Given IV
15956470|NCT03214562|Drug|Idarubicin|Given IV
15956471|NCT03214562|Biological|Pegfilgrastim|Given SC
15956472|NCT03214562|Drug|Venetoclax|Given PO
15956473|NCT03214549|Procedure|gull wing preparation of laminates veneers|preparation involving mesial and distal extension further lingualy.
15956474|NCT03214549|Procedure|conventional preparation of laminates veneers|preparation not involving mesial and distal extension further lingualy.
15956475|NCT03214536|Procedure|erector spinae block|bilateral injection of local anaesthetic between the erector spinae muscle and the transverse process
15956476|NCT03214536|Drug|Ropivacaine|injection of 20 ml ropivacaine 0.375 % bilateral by erector spinae block
15956477|NCT03214536|Procedure|Spine surgery|Surgery of lumbar spine
15956478|NCT03214536|Procedure|anesthesia|general anesthesia
15956479|NCT03214523|Behavioral|Sleep Education|The subject will undergo a 30-minute session on sleep education from one of the study coordinators.
15956480|NCT03214510|Drug|Bupivacaine|Given via thoracic epidural catheter or TAP block
15956481|NCT03214510|Drug|Fentanyl|Given via thoracic epidural catheter
15956482|NCT03214510|Drug|Hydromorphone Hydrochloride|Given via thoracic epidural catheter
15956483|NCT03214510|Device|Implanted Medical Device|Undergo placement of thoracic epidural catheter
15956484|NCT03214510|Device|Implanted Medical Device|Undergo placement of ultrasound-guided, four-quadrant transversus abdominus plane block
15956485|NCT03214510|Drug|Liposomal Bupivacaine|Given via TAP block
15956486|NCT03214510|Behavioral|Questionnaire|Ancillary studies
15956487|NCT03214497|Device|Protector|All patients which are assigned to the Protector are studied with this laryngeal mask
15956488|NCT03214497|Device|Supreme|All patients which are assigned to the Supreme are studied with this laryngeal mask
15956489|NCT03214484|Other|By comparing the evolution of the visual acuity curves.|By comparing the evolution of the curves, the investigator can confirm that the AV measured on ET / Computer can be an interesting and useful element to help us follow up our patients and improve the quality of life's patients by decreasing the number of visits control.
15956490|NCT03214484|Other|By comparing the evolution of the curves.|By comparing the evolution of the curves, the investigator can confirm that the AV measured on ET / Computer can be an interesting and useful element to help us follow up our patients and improve the quality of life's patients by decreasing the number of visits control.
15956491|NCT03214471|Behavioral|Lifestyle intervention|Nutritional and behavioural tele-counselling , self-monitoring and a 12-week supervised tailored exercise programme. Participants will receive a regular tele-counselling throughout the 12-month. Each session will take approximately 15 minutes, underpinned by behavioural psychological techniques. After their 3-month post-surgery assessment visit, participants in the BARI-LIFESTYLE Intervention Study will be enrolled in a supervised exercise programme at health facility gyms for 12 weeks.
15956492|NCT03214458|Device|Nasal high flow|The AIRVO 2 is for the treatment of spontaneously breathing patients who would benefit from receiving high flow warmed and humidified respiratory gases/
15956493|NCT03214445|Procedure|Sealing margins with flow composite|Seal the margin of restoration with Composite flow with nanofiller
15956494|NCT03214445|Procedure|Sealing margins with seal|Seal the margin of restoration with sealant without filler
15956498|NCT03214393|Diagnostic Test|serum antibodies|serum antibodies will be measured for pregnant women with Pre-Eclampsia
15956499|NCT03214380|Drug|LY900014|Administered SC
15956500|NCT03214380|Drug|Insulin Lispro|Administered SC
15956501|NCT03214380|Drug|Insulin Glargine|Administered SC
15956502|NCT03214380|Drug|Insulin Degludec|Administered SC
15956503|NCT03214380|Drug|Metformin|Administered orally.
15956504|NCT03214380|Drug|SGLT2 inhibitor|Administered orally.
15956505|NCT03214367|Drug|LY900014|Administered SC
15956506|NCT03214367|Drug|Insulin Lispro|Administered SC
15956507|NCT03214367|Drug|Insulin Glargine|Administered SC
15956508|NCT03214367|Drug|Insulin Degludec|Administered SC
15956509|NCT03214354|Drug|Alemtuzumab|Alemtuzumab, Day -7 to -3. Dose: 0.2mg/kg/dose SC once daily x 5 days
15956510|NCT03214354|Radiation|Total Body Irradiation|TBI 300 cGy on Day -2
15956511|NCT03214354|Drug|Sirolimus|Sirolimus is used for GVHD prophylaxis
15956512|NCT03214341|Radiation|MRI diffusion|using MRI diffusion to differentiate between benign and malignant mediastinal masses
15956513|NCT03214328|Diagnostic Test|Determination of causes of fetal death|Determination of causes of fetal death using systematic protocol testing
15956514|NCT03214315|Procedure|Visceral adipose tissue specimen|specimen
15956515|NCT03214302|Drug|Tenofovir Disoproxil Fumarate|Tenofovir Disoproxil Fumarate was used for the experimental group of pregnancy women in the 32 weeks during pregnancy
15956516|NCT03214289|Biological|Fecal Microbiota Transplantation|Thirty fecal microbiota capsules produced from a single healthy donor, unrelated to the participant.
15956517|NCT03214276|Dietary Supplement|Vinitrox polyphenols|Vinitrox™ (Nexira - France) is a combination of specific profile polyphenols from grape and apple. The main polyphenol classes are proanthocyanidins (as catechins, B2 dimer), phenolic acids (as chlorogenic acids, gallic acids) and anthocyanins (as malvidin-3-glucoside). It was administrated the night and the morning before the endurance test (oral administration)
15956518|NCT03214276|Dietary Supplement|Placebo|Made with maltodextrin. It was administrated the night and the morning before the endurance test (oral administration).
15956519|NCT03214250|Drug|APX005M|Administer intravenously once every 28-day Cycle
15956520|NCT03214250|Drug|Nivolumab|Administer intravenously twice every 28-day cycle
15956521|NCT03214250|Drug|Nab-Paclitaxel|Administer intravenously on 3 times every 28-day cycle
15956522|NCT03214250|Drug|Gemcitabine|Administer intravenously 3 times every 28-day cycle
15956523|NCT03214237|Other|no intervention - cross-sectional observational only|no intervention - cross-sectional observational only
15956524|NCT03214224|Device|remote pulmonary function testing|Telemedicine delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
15956525|NCT03214224|Device|standard pulmonary function testing|Standard clinical delivery of pulmonary function testing in ALS, including Forced Vital Capacity (FVC) and Maximal Inspiratory Pressure (MIP)
15956526|NCT03214198|Drug|Vonoprazan|Vonoprazan tablets
15956527|NCT03214185|Procedure|IVF/ICSI|in vitro fertilization or intracytoplasmatic sperm injection
15956528|NCT03214185|Genetic|PGS 2.0|Blastocysts are selected by PGS 2.0(NGS based) and only euploid embryos will be transferred.
15956529|NCT03214185|Other|Conventional embryo morphology evaluation|Blastocysts are selected by morphology criteria and only good-scored embryo will be transferred.
15956530|NCT03214172|Drug|Rivaroxaban (Xarelto, BAY59-7939)|15/20 mg
15956531|NCT03214159|Drug|Ritonavir Tablet 100mg|Ritonavir Tablet 100mg is a generic product manufactured by Ascletis Pharmaceutical Co., Ltd.
15956532|NCT03214159|Drug|NORVIR tablet 100mg|NORVIR Tablet is a generic product manufactured by AbbVie. NORVIR Tablet 100mg will be used as a comparator drug for the BE study.
15956533|NCT03214146|Biological|HYNRCS-Allo inj|The patients enrolled in the trial will be successively allocated into single cohort for HYNRCS-Allo inj., 1.0 X 10^6 cells/kg according to the protocol design.
15956534|NCT03214133|Other|Epicatechin-rich cocoa dose response|Subjects consume randomized doses of 0, 1, 2, 3 mg epicatechin/kg from epicatechin-rich cocoa. The optimal dose of epicatechin-rich chocolate will be the dose which have the greatest increase PNIP levels.
15956535|NCT03214133|Other|Epicatechin-rich cocoa vs placebo on performance|An optimized dose of epicatechin-rich cocoa or placebo will be given for 3 weeks alongside a prescribed power-based training program. In a randomized parallel design the effect of the optimal dose of epicatechin-rich chocolate, compared to placebo, on maximal isometric squat force, RFD, and jump testing will be quantified.
15956536|NCT03214107|Other|Exercise|Participants will be admitted at IRCM at 14:00. At 15:30, participants will performed a 60-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity). During exercise, capillary glucose levels will be measured every 10 minutes. At 16:30, the exercise will be completed and capillary glucose levels will be monitored every 20 minutes for 1 hour. At 17:30, the participant will be discharged.
15956537|NCT03214107|Other|Snack|Full snack or Distributed snack
15956538|NCT03214094|Drug|Vonoprazan|Vonoprazan tablets
15956539|NCT03214081|Drug|Vonoprazan|Vonoprazan tablets
15956540|NCT03214055|Drug|Mannitol|The mannitol has been administered routinely to prevent renal dysfunction in patients undergoing robot-assisted laparoscopic radical prostatectomy. Participants will receive the mannitol as part of routine medical care, and we will evaluate the change in optic nerve sheath diameters before and after mannitol administration.
15956541|NCT03214042|Device|K-rod dynamic stabilization system|Sixty-seven patients with lumbar degenerative diseases were treated with K-rod dynamic stabilization system. All patients were followed for 2 years. K-rod dynamic stabilization system was purchased from Biotech, USA, consisting of titanium alloy pedicle screw, titanium alloy line and polyether ether ketone (PEEK) shell between pedicle screw heads.
15956542|NCT03214029|Diagnostic Test|Cardiac troponin testing|Fresh EDTA plasma samples will be measured with both the hs-cTnI (Abbott) and hs-cTnT (Roche) assays.
15956543|NCT03214016|Other|Aerobic Exercise|1 hour of aerobic training on a treadmill, 3 times a week, during 8 weeks.
15956544|NCT03214016|Other|Pilates|1 hour of Mat Pilates, 2 times a week, during 8 weeks.
15956545|NCT03214003|Radiation|SIB|patients will recieve twice-daily radiotherapy by simultaneous integrated boosting technique concurrent with chemotherapy
15956546|NCT03214003|Radiation|Standard|patients will recieve standard twice-daily radiotherapy concurrent with chemotherapy
15956547|NCT03213990|Other|Continuous infusion|Clinician prescribed beta-lactam antibiotic will be administered via continuous infusion for as long as prescribed whilst in the ICU
15956548|NCT03213990|Other|Intermittent infusion|Clinician prescribed beta-lactam antibiotic will be administered via intermittent infusion for as long as prescribed whilst in the ICU
15956549|NCT03213977|Drug|R-DA-EPOCH|R-DA-EPOCH-21 treatment without auto-SCT for DLBCL patients age between 16 to 60 years with intermediate and high risk for IPI.
15956550|NCT03213977|Drug|R-DA-EPOCH + auto-HSCT|R-DA-EPOCH-21 treatment with auto-SCT for DLBCL patients age between 16 to 60 years with intermediate and high risk for IPI.
15956551|NCT03213977|Drug|R-CEOP90|R-CEOP90 treatment without auto-SCT for DLBCL patients age between 16 to 60 years with intermediate and high risk for IPI.
15956552|NCT03213977|Drug|R-CEOP90 + auto-HSCT|R-CEOP90 treatment with auto-SCT for DLBCL patients age between 16 to 60 years with intermediate and high risk for IPI.
15956553|NCT03213964|Biological|FATE-NK100|"FATE-NK100 Infusion (Day 0)
~The FATE-NK100 product will be placed in approximately 100 cc of 5% human serum albumin.
~Dose Level 1: 1 x 10^7 cells/kg IP
~Dose Level 2: >1x10^7 cells/kg to ≤3x10^7 cells/kg
~Dose Level 3: Complete FATE-NK100 bag (≥3 x 10^7 to ≤ 10 x 10^7 cells/kg)"
15956554|NCT03213964|Drug|Interleukin-2|"Interleukin-2 (begin Day 0): 6 million units three times a week for a total of 6 doses. For patients weighing less than 45 kilograms, the IL-2 will be given at 3 million units/m2 three times a week for 6 doses.
~The 1st dose will be given immediately (within 30 minutes) after the FATE-NK100 cell infusion on Day 0 as an inpatient. The remaining doses will be given in an outpatient setting."
15956555|NCT03213951|Other|Experimental beta probe|3mCi (or similar) dose of 68Ga-PSMA-11 will be given prior to resection of cancer. Experimental beta probe designed to detect 68Ga-PSMA-11 will be used on prostate tissue after it has been surgically removed.
15956556|NCT03213951|Diagnostic Test|PSMA-PET|PSMA-PET imaging done prior to surgery and compared to whole mount imaging.
15956557|NCT03213938|Device|Acupuncture|"For acupuncture group, Hwato brand disposable acupuncture needles (size 0.30 × 75mm; size 0.30 × 40mm) will be used. Bilateral SP6, BL33, BL23, and BL35, were selected as acupoints protocol.
~Acupuncture group consists of 20 sessions over an 8-week period after baseline, each for 30 minutes, and will be administered over 8 weeks (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks)."
15956558|NCT03213938|Device|Sham acupuncture|"For sham acupuncture group, Hwato brand disposable acupuncture needles (size 0.30 × 25mm) will be used to insert vertically about 2-3 mm without manipulation into non-acupoints bilateral sham SP6, sham BL33, sham BL23, and sham BL35, which were located at different physical locations than SP6, BL23, BL 33, and BL35.
~Sham acupuncture group consists of 20 sessions over an 8-week period after baseline, each for 30 minutes, and will be administered over 8 weeks (3 sessions in each of the first 4 weeks, and 2 sessions in each of the remaining 4 weeks)."
15956559|NCT03213925|Radiation|Radiation therapy|"Radiation therapy to the breast with or without regional nodal area is performed within 12 weeks after completion of chemotherapy with conventional dose (25x200cGy). Additional boost of 16 Gy in the primary involved tumor region.
~Techniques: 3D conformal radiation therapy or intensity modulated radiation therapy (IMRT).
~Standard systemic treatment for patients with hormonal positive receptor (hormone therapy for at least 5 years) and HER2 positive (trastuzumab for 1 year)"
15956560|NCT03213886|Drug|Calcifediol (Vitamin D)|"After surgical treatment, participants with vitamin D deficiency (25OHD < 30 ng/mL) will be randomly allocated to an intervention group or control group.
~For the intervention group, participants will receive 16. 000 U oral Calcifediol daily for 5 days.
~For the control group, participants will receive 16.000 U oral Calcifediol weekly for 5 weeks.
~Both groups:
~Will follow the usual hip fracture rehabilitation pathway.
~25OHD serum levels will be measured after 4 weeks. Depending on the serum 25OHD level, the patients will receive different vitamin D strategies (according to the protocol) Patients will be monitored for up to 12 months after the discharge from the hospital, with 3 clinic visits at 3, 6 and 12 months (to determine serum vitamin D levels and to evaluate functional status)"
15956561|NCT03213873|Behavioral|HiBalance|Intervention of highly challenging balance training for 10 weeks.
15956562|NCT03213873|Behavioral|Speech and communication therapy|Intervention conducted by speech and language therapist for 10 weeks.
15956563|NCT03213860|Other|Flight Eye-masks; Dreaming, Zhuji City, Zhejiang, China|The experimental group will receive protective devices Single use eye masks during nocturnal sleep (Flight Eye-masks; Dreaming, Zhuji City, Zhejiang, China). The caregiver will explain to them that they should wear eye masks during their stay in ICU to ensure rest and instructed patients to use them properly. During the ICU stay, ICU nurses will assist patients with wearing eye masks from 9:00 pm to 7:00 am the next morning.
15956564|NCT03213847|Device|Superb microvascular imaging (SMI) (Toshiba)|to determine whether there is a correlation between the increased intraneural flow as measured using Doppler US and SMI methods and the severity of CTS as measured by nerve conduction studies, we designed this study
15956565|NCT03213834|Procedure|Chest thoracoscopy|Thoracoscopy will be performed as per standard protocols, with patient lateral decubitus position. Ten mLs of fluid will be collected to check for biomarkers. Adhesiolysis will be attempted and pleural irrigation will be done. At the end of the procedure, a drain will be inserted and connected to an underwater seal with a negative pressure suction
15956566|NCT03213834|Procedure|Chest fibrinolytic therapy|A chest tube will be inserted under ultrasonography into the most dependent area of the pleural effusion or into the largest loculation in patients with multi-loculated effusions. A of DNase and tPA will be given. Concurrent tPA and DNase will be administered intrapleurally through the chest tube followed by saline flush. The tube will then be clamped for 120 minutes and after which it will be connected back to wall suction. The intrapleural therapy will be given twice daily for a maximum of 6 doses.
15956567|NCT03213834|Drug|tPA|tPA administered intrapleurally through the chest tube followed by saline flush. The intrapleural therapy will be given twice daily for a maximum of 6 doses.
15956568|NCT03213834|Drug|DNase|DNase administered intrapleurally through the chest tube followed by saline flush. The intrapleural therapy will be given twice daily for a maximum of 6 doses.
15956628|NCT03213392|Drug|Anesthetic Agents|four different anesthetic agents will be used during the surgical clipping or coiling of the aneurysm for the maintenance of anesthesia.
15956856|NCT03211507|Other|Computer-assisted telephone interview|Occupational history
15956569|NCT03213821|Other|protein intake|For each participant, weighed food records of 3 consecutive days will be analyzed for estimation of calorie and macronutrient intake and dietary preferences. To make sure good compliance, diets will be developed regarding patient's dietary habits and preferences individually. High calorie (30-35 kcal/kg Ideal body weight) diets including 6-8 small meals will be formulated. Intervention group will receive high protein diet as recommended to preserve muscle mass (1.2-1.5 g/kg IBW). Comparison group will receive protein based on GFR to preserve renal function. For older adults (>65 years) protein content of diet will be as recommended by the international study group to review dietary protein needs with aging (PROT-AGE). In subjects with lower intake of protein, carbohydrate will be substituted. Both group will receive low fat diet.
15956570|NCT03213808|Other|No intervention: analysis of health data from patients with|No intervention: analysis of health data from patients with respiratory allergies (asthma, rhinitis), skin allergies (dermatitis, urticarial, angioedema), anaphylaxis, gastrointestinal allergic conditions and ocular allergies (conjunctivitis) for the validation of the chapter allergies and hypersensitivity in the future version of the WHO CIM
15956571|NCT03213782|Other|Nature based sounds|Nature based sound was administered to the experimental group with head phones for continuously 20minutes. Posttest was done by continuously 30 minute observation after administration of nature based sound with the same tools.
15956572|NCT03213769|Drug|topical coenzyme Q10 gel|Q10 gel will give 2 times /day after breakfast and evening meal for 7 days.
15956573|NCT03213769|Drug|Carpabol gel|placebo carbapol gel will give 2 times /day after breakfast and evening meal for 7 days.
15956574|NCT03213756|Device|Isometric exercises using Hand grip and elastic bands|"Isometric exercises using hand-grip. This exercise consists of two sets of 30 hand-grip contractions with the hand of the upper arm candidate for AVF (in case of doubts about the most appropriate arm for AVF the exercise will be performed with both arms). The patient will rest one minute every 10 contractions and 5 minutes between both sets. The patient will repeat this protocol twice a day, morning and night (Approximately 15 minutes each session). The contraction intensity will start with half of the maximum force obtained by dynamometry and will be increased or decreased to be placed on an effort intensity 2-3 in the Borg scale.
~Isometric exercise using elastic bands. At noon the patient will perform a slow contraction session using elastic band with 20 slow repetitions with the arm in flexion and 20 repetitions with the arm in extension. (Total duration: less than 10 minutes)"
15956575|NCT03213743|Drug|Dexmedetomidine Injection|Investigators gave the patients loading dose of dexmedetomidine for 10 minutes and maintaining dose of dexmedetomidine for 20 minutes. Investigators took blood samples before and after the administration of dexmedetomidine.
15956576|NCT03213730|Other|3D-MOT Neurotracker|"A predetermined number of spheres (eight) are presented in the 3D-MOT task. The spheres are all identical in shape and color. Before each trial, four spheres are highlighted, and then returned to their original color. Participants will be asked to track those four spheres for the duration of the trial (8 seconds). Spheres will be moving, bouncing, colliding, until they finally stop moving and the participant has to identify the spheres that were initially highlighted. Previous work with healthy individuals has shown that the minimum optimal number of sessions (3 blocks) necessary to induce brain plasticity and enhance other, non-trained brain functions is between 5-6. The training protocol will therefore include 6 sessions (3 blocks each), at intervals of 48 to 72 hours, over a maximum of 3 weeks."
15956577|NCT03213730|Other|Visual Attention Intervention|The visual attention intervention will consist of the 2048 game, a single-player sliding block puzzle game of which the objective is to slide numbered tiles on a grid to combine them to create number 2048. 2048 is played on a gray 4×4 grid, with numbered tiles that slide smoothly when a player moves them using the four arrow keys. Every turn, a new tile will randomly appear in an empty spot on the board with a value of either 2 or 4.Tiles slide as far as possible in the chosen direction until they are stopped by either another tile or the edge of the grid. If two tiles of the same number collide while moving, they will merge into a tile with the total value of the two tiles that collided. Higher-scoring tiles emit a soft glow. Children will play for a time equivalent to that of the 3D-MOT.
15956578|NCT03213717|Other|Heavy Casall HIT weight vest|A weight west with a weight of 10 % compared to the study subject
15956579|NCT03213717|Behavioral|Standing|Study subjects will be standing for at least 50 minutes every hour
15956580|NCT03213717|Dietary Supplement|Water load|Study subjects will drink 5 ml per kg body weight at the start of experiment and continue drinking the same volume as excreted by the kidneys during the experiment
15956581|NCT03213717|Behavioral|Sitting|Study subjects will be sitting for at least 50 minutes of every hour
15956582|NCT03213717|Other|Light Casall HIT weight vest|A weight west with a weight of 1 % compared to the study subject
15956585|NCT03213691|Other|Laboratory Biomarker Analysis|Correlative studies
15956586|NCT03213691|Drug|Selumetinib|Given PO
15956587|NCT03213691|Drug|Selumetinib Sulfate|Given PO
15956591|NCT03213665|Drug|Tazemetostat|Given PO
15956595|NCT03213639|Drug|Esomeprazole 40 mg Oral Tablet|once daily oral tablets
15956596|NCT03213639|Drug|Placebo Oral Tablet|once daily oral tablets
15956597|NCT03213626|Drug|Cabozantinib 40 MG|To be taken orally once daily
15956598|NCT03213626|Drug|Erlotinib 100Mg Tab|To be taken orally once daily
15956599|NCT03213613|Behavioral|Adaptive Attention Training|The training is comprised of a time-based titration of rich audiovisual and sparse audio interactive environments. Training progressively transitions the participants from an immersive and rapid reward setting to a less immersive, sensory impoverished, and slower reward setting. Further, the participants' actions require delayed gratification decisions to accomplish play in the sparse setting, building fronto-parietal control through sustained attention and suppression of ventral-striatal reward impulses.
15956717|NCT03212716|Drug|Oseltamivir|150 mg twice a day during 10 days (ANSM guidelines for severe flu).
15956600|NCT03213613|Behavioral|Active Control|Participants in the expectancy-matched active control group will play a visuo-spatial iPad game, in which players use their finger to move an object to different successive square platforms. Expectancy matching to the adaptive attention training was pre-confirmed in 121 participants (18-20 years of age), using targeted surveys on MTurk about their expectations of either training exposure on our specific outcome measures. To balance expectations of potential benefits, this group will receive identical recruitment and experimental instructions as the adaptive attention training group.
15956601|NCT03213613|Behavioral|Low-dose Adaptive Attention Training|Participants in the low-dose training group will play a reduced number of sessions as the Adaptive Attention Training group. Specifically, they will train for two 30-minute sessions at the start and middle of a six-week period. To balance expectations of potential benefits, this group will receive identical recruitment and experimental instructions as the adaptive attention training group.
15956602|NCT03213600|Device|transcranial Direct Current Stimulation tDCS|75 participants will receive 20 minutes of active tDCS (1,5mA, 20 minutes stimulation over frontal (F3/F4) electrodes ); A group of 75 participants will receive 1,5mA 20 minutes of stimulation over parietal (CP3 CP4) electrodes. During this stimulation session and we will also measure your ability to perceive visual and auditory objects presented by a computer, while recording your brain activity using electroencephalography or EEG (a technique using electrodes that measures the electrical activity of your brain)
15956603|NCT03213587|Drug|Apatinib|500 mg qd p.o. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
15956604|NCT03213574|Other|Control Group|Intraoperative fluids will be administer per the discretion of anesthesia provider and not per SVV data or study protocol.
15956605|NCT03213574|Other|Treatment Group|FloTrac arterial line data will be used to administer fluid bolus, based on study algorithm.
15956606|NCT03213561|Device|Stable and Independent Brain-computer Interfaces for Communication|"The participants will perform an MRI head scan, which the investigators will use to construct 3D head models of participants. The investigators will use these modele to reconstruct the activity of brain sources from EEG signals. The participants will then take part in a series of EEG recording sessions. During the initial calibration sessions, the participants will react with real or attempted movements to visual cues. The investigators will use the EEG signals from these sessions to calibrate the text-entry interface used in the validation sessions that follow. During the validation sessions, the participants will control the text-entry interface to write messages using their EEG signals."
15956607|NCT03213548|Procedure|Alar facial groove incision|All procedures related to alterations in the alar base will be based on an algorithm proposed by 2010 Adamnson et al lar Soft-Tissue Techniques in Rhinoplasty Algorithmic Approach, Quantifiable Guidelines, and Scar Outcomes From a Single Surgeon Experience ,published at Archives Facial Plastic Surgery in which a sequential approach is used, evaluating step-by-step surgical needs. Initially, the alar base can be reduced by removing tissue from the nasal sill. At this step, modifications at the shape or the width of the nostrils can be done. After that, a rotation-advancement flap is made, and the sill defect is closed. The nasal flair is then assessed and tissue from the alar border can be removed if needed. The incisions not spare the alar facial groove.
15956608|NCT03213548|Procedure|Alar facial groove spared|The technique is the same of the Alar facial groove incision intervention group, but the incisions spare the groove. The incisions will be at 1 mm above the groove.
15956609|NCT03213522|Procedure|Pelvic Floor Physical Therapy|Educating the PFPT group on therapeutic exercise, which includes, but not limited to, the pelvic brace, pelvic floor muscle exercise, and diaphragmatic breathing. If the patient is presenting with hypertonia of lower extremity muscles and/or muscles connecting to or part of the pelvic floor, the patient may be instructed on gentle static stretching and/or treated with passive stretching and diaphragmatic breathing.
15956610|NCT03213522|Procedure|Craniosacral Therapy|Modified Upledger Institute 10-step protocol.
15956611|NCT03213509|Other|Interview (Social and Verbal Autopsy)|Verbal autopsy is a technique used to determine the cause of death by asking caregivers, friends or family members about signs and symptoms exhibited by the deceased in the period before death. This is usually done using a standardized questionnaire that collects details on signs, symptoms, complaints and any medical history or events. The cause of death, or the sequence of causes that led to death, are assigned based on the data collected by this questionnaire and on any other available information. The social autopsy tool is used in conjunction with the verbal autopsy tool to explore the non-biological factors contributing to a death, including the social, behavioural and health systems determinants of maternal and child deaths.
15956612|NCT03213496|Behavioral|Walk prescription|30-40 minutes daily, for five days at the week, all weeks up to surgery.
15956613|NCT03213496|Other|Conventional care|Patient do not walk before surgery
15956614|NCT03213483|Procedure|Coronally advanced flap and subepithelial connective tissue graft|The connective tissue graft is obtained by a single line incision from the palate.
15956615|NCT03213483|Procedure|Coronally advanced flap and deepithelialized free gingival graft|The connective tissue graft is obtained by deepithelialization of a free gingival graft.
15956616|NCT03213470|Other|magnetic resonance imaging|
15956617|NCT03213457|Drug|Estradiol/Norethindrone Acetate|Tablets
15956618|NCT03213457|Drug|Placebo for Elagolix|Tablet
15956619|NCT03213457|Drug|Elagolix|Tablet
15956620|NCT03213457|Drug|Placebo for E2/NETA|Tablets
15956621|NCT03213444|Drug|adjuvant chemotherapy with 5-FU isolated|Patients submitted to adjuvant chemotherapy with 5-FU isolated
15956622|NCT03213444|Drug|adjuvant chemotherapy with 5-FU associated with oxaliplatin|Patients submitted to adjuvant chemotherapy with 5-FU associated with oxaliplatin
15956623|NCT03213418|Behavioral|Contingency management|Contingency management is an evidence-based psychotherapy program that promotes behavioral change with financial incentives.
15956624|NCT03213405|Biological|rBCG-N-hRSV 1/100|5x10^3 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection.
15956625|NCT03213405|Biological|rBCG-N-hRSV 1/10|5x10^4 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection.
15956626|NCT03213405|Biological|rBCG-N-hRSV full dose|1x10^5 colony forming units (CFU) of rBCG-N-hRSV will be administered as an intradermal injection.
15956627|NCT03213405|Biological|Conventional BCG full dose|2x10^5 colony forming units (CFU) of conventional BCG will be administered as an intradermal injection.
15956629|NCT03213379|Device|Actimetry measures|The patient will wear actigraphy bracelet during a week that will enable to record patients' movements. The report based on the recording will provide an assessment of daytime somnolence and an indication of propensity for impulsive behaviours.The intervention consisted in 2 supplementary actimetry measures and sending of the actimetry reports to the investigator.
15956630|NCT03213366|Behavioral|E-PrEP- Peer-Led Intervention about PrEP|Intervention contents and targets were informed by a systematic review of PrEP barriers and facilitators, a locally conducted qualitative study, and key informant and peer leader inputs. The contents were developed or adapted by study staff and peer leaders. Components and associated text have been designed to engage participants in online discussions about PrEP and related health and social topics. Posts will also include information about linkage-to-care, and insurance access. New contents will be posted almost daily.
15956631|NCT03213366|Behavioral|BxNow - General Health Campaign|BxNow will focus on general health topics unrelated to HIV or sexual health (i.e. fitness, nutrition, smoking), as chosen by PLs. Contents will be developed or adapted by PLs and posted almost daily. Posts will also include information about linkage-to-care and insurance access. At the end of the intervention, BxNow participants will be exposed to E-PrEP components at the end of the trial.
15956632|NCT03213353|Drug|Tablet paracetamol, guaifenesin and phenylephrine HCL|Each subject will receive two tablets, each containing 250 mg paracetamol, 100 mg guaifenesin, and 5 mg phenylephrine hydrochloride
15956633|NCT03213353|Drug|Vicks Active SymptoMax Plus powder for oral solution|Each subject will receive one sachet, containing 500 mg paracetamol, 200 mg guaifenesin, and 10 mg phenylephrine hydrochloride
15956634|NCT03213340|Other|Catechin Cohort 1|- 4 capsules taken with water 1 hour prior to meal
15956635|NCT03213340|Other|Curcuminoid Cohort 2|- 2 capsules taken with water 1 hour prior to meal
15956636|NCT03213340|Other|Flavonoid Cohort 3|- ~ 1 oz. serving consumed 30 minutes before meal
15956637|NCT03213327|Device|StayOk web application|Patients fill in the questionnaires of the web application and receive an analyzed profile of their psychosocial condition and health-promoting advices
15956638|NCT03213314|Diagnostic Test|Multiparameter magnetic resonance imaging|LiverMultiScan before and after surgery to assess liver health prior to liver resection and in the regenerative phase.
15956639|NCT03213301|Drug|Lurbinectedin|3.2 mg/m2 i.v. every 3 weeks
15956640|NCT03213288|Dietary Supplement|Delphinidin type anthocyanins|Bilberry extract containing Delphinidin type anthocyanins
15956641|NCT03213288|Dietary Supplement|Cyanidin type anthocyanins|Black rice extract containing Cyanidin type anthocyanins
15956642|NCT03213288|Dietary Supplement|Placebo|No anthocyanins
15956643|NCT03213275|Other|Microbiome Sequencing, Neurophysiologic Assessment, Immunological test|Stool sampling, aEEG, VEP, NIRS, ydTCR, Treg, biomarker
15956644|NCT03213249|Other|Normal saline|Intraoperative pocket irrigation with normal saline
15956645|NCT03213249|Drug|Cefazolin|Cefazolin, gentamicin, and bacitracin will be mixed together in 1 L of normal saline and placed in the pocket created by the breast once it is removed
15956646|NCT03213249|Procedure|Skin biopsy|Biopsies will be taken from the skin at the time of mastectomy and at the time of implant exchange.
15956647|NCT03213249|Procedure|Bilateral skin- or nipple-sparing mastectomies|Standard of care
15956648|NCT03213249|Device|Tissue expander|Standard of care
15956649|NCT03213249|Device|Breast implant|"Standard of care
~Either breast implant or autologous flap"
15956650|NCT03213249|Procedure|Autologous flap|"Standard of care
~Either breast implant or autologous flap"
15956651|NCT03213249|Other|Acellular dermal matrix sling|Standard of care
15956652|NCT03213249|Drug|Gentamicin|Cefazolin, gentamicin, and bacitracin will be mixed together in 1 L of normal saline and placed in the pocket created by the breast once it is removed
15956653|NCT03213249|Drug|Bacitracin|Cefazolin, gentamicin, and bacitracin will be mixed together in 1 L of normal saline and placed in the pocket created by the breast once it is removed
15956654|NCT03213236|Diagnostic Test|Homemonitoring diagnostic system|"In addition to the standard full-night diagnostic polysomnography, patients will be evaluated during the same night with a homemonitoring diagnostic system that consists out of a pulse oximeter, accelerometer, smartphone for audio recording and a mattress that measures the ballistocardiogram."
15956655|NCT03213210|Device|easy-graft CLASSIC (beta-Tricalcium Phosphate)|easy-graft will be grafted to the bone defect supporting a dental implant and covered by polylactide membrane to facilitate regeneration of new bone and healthy attachment to stabilize the dental implant.
15956656|NCT03213197|Other|CPR video|Patient watches a short CPR video
15956657|NCT03213171|Behavioral|Reception staff providing handout.|Reception staff will provide an educational pamphlet to patients that have not yet registered for organ donation
15956658|NCT03213171|Behavioral|Mobile Tablet (e.g. iPad)|Patients will have the opportunity to immediately register for organ donation using an a mobile tablet (e.g. IPad)
15956659|NCT03213158|Drug|Ixazomib Oral Capsule|Highly sensitized kidney transplant candidates on the waitlist for more than 24 months will receive ixazomib 3 mg (and dexamethasone 20 mg) on days 1, 8, and 15 of a 28 cycle. Patients will take ixazomib and dexamethasone for twelve (12) 28-day cycles.
15956660|NCT03213145|Drug|intraconazole|Subjects will receive itraconazole once daily from Day 5 through Day18
15956661|NCT03213145|Drug|Rifampin|Subjects will receive rifampin once daily from Day 5 through Day 16
15956662|NCT03213145|Drug|EDP 305|Subjects will receive EDP 305 once daily on Day 1 and Day 14
15956663|NCT03213132|Behavioral|SHUTi (Sleep Health Using the Internet)|Cognitive Behavioral Therapy for insomnia delivered online and metered out over 6 weeks in a fully automated, interactive, tailored web-based program
15956664|NCT03213132|Behavioral|Patient Education|Educational website containing information on insomnia
15956665|NCT03213119|Procedure|Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation.|Caloric vestibular stimulation (CVS) involves the irrigation of cold or warm water into the external ear canal, and induces a temperature gradient across the semicircular canals stimulating the vestibular nerve. It is commonly used in both otolaryngology to assess vestibular function and neurology to test brain stem function.
15956718|NCT03212716|Drug|Diltiazem|60 mgx3 per day during 10 days.
15956719|NCT03212716|Drug|Placebos|Placebo of diltiazem
15956857|NCT03211507|Genetic|Genetic analysis|To include analysis of known susceptibility markers
15956666|NCT03213119|Procedure|Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation.|Caloric vestibular stimulation (CVS) involves the irrigation of cold or warm water into the external ear canal, and induces a temperature gradient across the semicircular canals stimulating the vestibular nerve. It is commonly used in both otolaryngology to assess vestibular function and neurology to test brain stem function.
15956667|NCT03213119|Procedure|Non-invasive brain stimulation of the vestibular system through caloric vestibular stimulation.|Caloric vestibular stimulation (CVS) involves the irrigation of cold or warm water into the external ear canal, and induces a temperature gradient across the semicircular canals stimulating the vestibular nerve. It is commonly used in both otolaryngology to assess vestibular function and neurology to test brain stem function. The SHAM condition uses body-temperature water, and thus does not result into vestibular unbalance.
15956668|NCT03213106|Device|Transcranial Magnetic Stimulation (TMS)|Low frequency (1Hz) transcranial magnetic stimulation aimed to the dentate nucleus contralateral to the most symptomatic side.
15956669|NCT03213106|Device|Sham Stimulation|The stimulation coil will be placed in the same spot as the TMS stimulation, but coil will not be attached to the TMS machine.
15956670|NCT03213093|Other|Measure of cutaneous microcirculation|Measure of cutaneous microcirculation in response to a local application of pressure, to local heating and to the iontophoretic administration of acetylcholine
15956671|NCT03213080|Device|Targeted Lung Denervation (TLD)|Targeted Lung Denervation (TLD) procedure.
15956672|NCT03213054|Biological|OBP-301|OBP-301 administration on the Day 1, Day 18 and Day 32
15956673|NCT03213054|Radiation|Radiation|Standard radiation therapy for esophageal cancer patient. total 60 Gy for 6 weeks
15956674|NCT03213041|Drug|Carboplatin|Given IV
15956675|NCT03213041|Other|Laboratory Biomarker Analysis|Correlative studies
15956676|NCT03213041|Biological|Pembrolizumab|Given IV
15956677|NCT03213028|Other|WHO Decision-Making Tool for Family Planning Clients and Providers|Contraception decision-making tool
15956678|NCT03213015|Diagnostic Test|Ankle dorsiflexion measurement|It was used the test with WB, called Lunge Test, in which each evaluator marked a point 15 cm distal to the anterior tuberosity of the tibia (TAT) with a felt tip pen. After that the smartphone (app iHand) will be placed at this point. Between each measurement, the mark was removed with alcohol 70% The demarcated point served as a guide for positioning the smartphone. In order to standardize the smartphone positioning, BHome (home button on the iPhone), was aligned with the TAT pen mark. To ensure the same distance from the foot to the test, the distance of the hallux to the wall was measured (tape measure), recorded and reused for each test.
15956679|NCT03213002|Drug|Capecitabine|Capecitabine at 1500 mg/m2
15956680|NCT03213002|Drug|Temozolomide|Temozolomide at 150 mg/m2 - 200 mg/m2
15956681|NCT03212989|Drug|Vorinostat|Participants meeting criteria for Step 1 (exhibit ex-vivo response to VOR) will progress to Step 2 where they will receive a single dose of VOR 400 mg followed by a leukapheresis. If an increase in cell-associated HIV RNA (ca-RNA) is observed in-vivo following the single VOR dose, they will be eligible to donate cells for the manufacture of HXTC (Step 3). Successful manufacturing of the HIV-1 antigen expanded specific T cells will progress participants to combination treatment in Steps 4 and 5. In Steps 4 and Step 5, participants will receive two series of VOR dosing and HXTC infusions, for a total 20 doses of VOR 400 mg and 5 HXTC infusions.
15956682|NCT03212989|Biological|HXTC|Participants meeting criteria for Step 1 (exhibit ex-vivo response to VOR) will progress to Step 2 where they will receive a single dose of VOR 400 mg followed by a leukapheresis. If an increase in cell-associated HIV RNA (ca-RNA) is observed in-vivo following the single VOR dose, they will be eligible to donate cells for the manufacture of HXTC (Step 3). Successful manufacturing of the HIV-1 antigen expanded specific T cells will progress participants to combination treatment in Steps 4 and 5. In Steps 4 and Step 5, participants will receive two series of VOR dosing and HXTC infusions, for a total 20 doses of VOR 400 mg and 5 HXTC infusions.
15956683|NCT03212976|Procedure|Phase contrast magnetic resonance imaging|Phase-contrast magnetic resonance imaging will be done to assess intracranial pressure
15956684|NCT03212963|Drug|Halobetasol Topical Lotion|Halobetasol Lotion 0.05%, applied twice daily in subjects aged 12 to 16 years 11 months with stable plaque psoriasis.
15956685|NCT03212950|Drug|Fast-CL|After the admission we will insert new insulin (blinded) into the insulin pump. At 13:00 they will have lunch (with manual bolus). At 15:00 we will start CL control, participants/investigators will not be allowed to deliver manual bolus till the end of the study period. All meals and afternoon exercise (in the time between 16:30 and 19:30) will be unannounced and managed with CL.
15956686|NCT03212950|Drug|Regular-CL|After the admission we will insert new insulin (blinded) into the insulin pump. At 13:00 they will have lunch (with manual bolus). At 15:00 we will start CL control, participants/investigators will not be allowed to deliver manual bolus till the end of the study period. All meals and afternoon exercise (in the time between 16:30 and 19:30) will be unannounced and managed with CL.
15956687|NCT03212937|Drug|Selinexor|Oral KPT-330 is administered on Day 3, 5, and 7 of each 21-day cycle. Starting dose is 40mg will be adjusted according to toxicity
15956688|NCT03212937|Drug|ICE Chemotherapy|"IV Ifosfamide 5g/m^2 on Day 2 (inpatient) or D1 (outpatient) of each 21-day cycle
~IV Carboplatin AUC 5 on Day 2 (inpatient) or D1-3 (outpatient) of each 21-day cycle
~IV Etoposide 100 mg/m^2 on Days 1-3 of each 21-day cycle"
15956689|NCT03212924|Behavioral|Pupillometry|Measure of pupil dilatation simultaneously to the evaluation of speech intelligibility. The variation of the pupil size is monitored during the presentation of speech stimuli in quiet and in the presence of a background noise.
15956690|NCT03212924|Behavioral|Evaluation of speech comprehension in quiet|Three lists of 17 monosyllabic words (Lafon) are presented in quiet at 65 dB SPL. Listeners have to repeat what they understood. The results correspond to the percent of phonemes correctly identified.
15956691|NCT03212924|Behavioral|Evaluation of speech comprehension in noise|Three lists of 17 monosyllabic words (Lafon) are presented in a wide band noise at 65 dB SPL with a SNR (signal to noise ratio) of +10 dB. Listeners have to repeat what they understood. The results correspond to the percent of phonemes correctly identified.
15956720|NCT03212703|Behavioral|Mindfulness-Based Skills Training (MBST)|8-week mindfulness skills training sessions based on Mindfulness-Based Cognitive Therapy (MBCT) program by Zindel Segal, Mark Williams and John Teasdale
15956721|NCT03212703|Other|Waitlist control (WLC)|Observation surveys at baseline, mid-point and end-point of an 8-week period
15956692|NCT03212924|Behavioral|MOCA|The Montreal Cognitive Assessment (MoCA) is a screening instrument to detect cognitive dysfunction. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The time to administer the MoCA is approximately 10 minutes. The total possible score is 30 points. The test suggests the existence of a cognitive impairment if the participant scores less than 26 points. The test is presented on a single sheet of paper.
15956693|NCT03212924|Behavioral|auto evaluation of listening effort in quiet|The participant has to represent, on a continuous line, the amount of listening effort he used when listening to the monosyllabic words presented in quiet. A score from 0 (no listening effort) to 10 (effort maximum) is extracted from his response.
15956694|NCT03212924|Behavioral|auto evaluation of listening effort in noise|The participant has to represent, on a continuous line, the amount of listening effort he used when listening to the monosyllabic words presented in the background noise. A score from 0 (no listening effort) to 10 (effort maximum) is extracted from his response.
15956695|NCT03212911|Biological|Hepatitis B vaccine|Hepatitis B vaccine (20 mcg/ml) 1 ml intramuscular injection in 3 (at 0, 1, 6 months) or 4 doses (0, 1, 2, 6 months)
15956696|NCT03212898|Other|anticoagulation care|Patients in the intervention group will: 1) have a repeated pharmacist-led education on all aspects of warfarin treatment; 2) receive enhanced medication instructions and a care and follow up plan; 3) receive a pill box 4) be refered to the GP with proposal for dose change when outside the therapeutic range or therapy modification to avoid drug interactions with warfarin
15956697|NCT03212885|Device|Deep Brain Stimulation|Electrode that provides electrical stimulation to deep brain structures for relief of Parkinson's Disease symptoms.
15956698|NCT03212872|Diagnostic Test|Endoscopy|
15956699|NCT03212859|Behavioral|Coach2Move|"Coach2Move is a multicomponent physiotherapeutic approach in addition to usual care physiotherapy consisting of:
~Extensive intake during which not only impairments and disabilities, but wishes, barriers and facilitators considering physical functioning are profoundly examined.
~Motivational interviewing is used to find and deal with barriers for becoming physically active and shared-decision making in goal setting.
~The approach is patient focused (tailor made) and goal-oriented: the physiotherapist coaches the patient and the environment in reaching and maintaining their own goals.
~In consultation with the patient, a stratified intervention is chosen by picking the best fitting option out of three patient-tailored intervention profiles with a predefined number of intervention sessions."
15956700|NCT03212859|Behavioral|Usual Care|"Usual care physiotherapy among older adults:
~Intake of 30 minutes consisting of examining medical history, physical functioning and functional exercises to assess the demand for care.
~Use of treatment modalities to enhance physical functioning (strength, mobility, coordination, balance etc.)
~Consultation and advisory role in relation to the functional status of geriatric patients and his/her relations.
~Collaborate with other disciplines in a multidisciplinary context."
15956701|NCT03212846|Other|Hippotherapy|Children will receive the hippotherapy treatment, based on horse walking in a regular way led by an experienced leader. Sessions will be performed for 45 minutes once weekly for 12 consecutive weeks in an indoor riding area.
15956702|NCT03212833|Diagnostic Test|fasting serum insulin|fasting serum insulin in chronic hepatitis C patients
15956703|NCT03212820|Procedure|Drilling at low speed|
15956704|NCT03212820|Procedure|Drilling at conventional or high speed|
15956705|NCT03212807|Drug|Durvalumab|Investigational Medicinal Product
15956706|NCT03212807|Drug|Lenalidomide|Investigational Medicinal Product
15956707|NCT03212794|Behavioral|Recovery coach|The recovery coach will support the subjects in the following areas: 1) monitor and manage symptoms, 2) patient education and self-management, and 3) enlisting community and social supports. Encouragement to continue treatment will be a primary focus of the recovery coach. In addition, the coach will conduct weekly sessions on various topics and offer personal insights and facilitate a discussion.
15956708|NCT03212781|Drug|Iron dextran|total dose infusion
15956709|NCT03212781|Drug|Ferrous Fumarate|oral tablets
15956710|NCT03212768|Procedure|Trans-syndesmotic fixation|antromedial approach for medial malleolus fractures, posterolateral or direct lateral approach for fibula fractures, direct fixation of third malleolus by posterior approach, Trans-syndesmotic fixation ,cement augmentation and Tibiotalocalcaneal fusion
15956711|NCT03212755|Diagnostic Test|serum immunoglobulin G level|measurement of the serum level as a marker of diabetic complications
15956712|NCT03212742|Drug|Olaparib|We propose 7 dose levels to reach the target dose of 400 mg per day (200 mg twice daily) of olaparib continuously DL1 (starting dose level) : Olaparib 50 mg Q12H Monday to wednesday DL2 : Olaparib 100mg Q12H Monday to wednesday DL3: Olaparib 100mg Q12H Monday to friday DL4 : Olaparib 200mg Q12H Monday to wednesday DL5: Olaparib 200mg Q12H Monday to friday DL6: Olaparib 200mg Q12H, continously
15956713|NCT03212742|Drug|Temozolomide (TMZ)|TMZ will be given at the dose of 75mg/m²/day during radiotherapy period. TMZ will be re-introduced 4 weeks after the end of radiotherapy at the dose of 150mg/m²/day on days 1 to 5 every 28 days, for a total of 6 cycles.
15956714|NCT03212742|Radiation|IMRT (Intensity Modulated Radiation Therapy)|Radiotherapy consists of fractionated focal irradiation at a dose of 2 Gy per fraction given once daily five days per week over 6 weeks, for a total dose of 60 Gy by 3D- Intensity-Modulated RT (IMRT)
15956715|NCT03212729|Radiation|ANTIMICROBIAL PHOTODYNAMIC THERAPY|The aPDT was performed with 0.01% methylene blue and irradiated with low-level laser therapy (InGaAIP, 660 nm; 100 mW; 40 sec) with an optical fiber-coupled. Another irradiation (3 J; 30 sec; spot size of 3 mm2) was performed in the gingiva close to the apical foramen.
15956716|NCT03212729|Procedure|Conventional endodontic treatment|After local anesthesia the supragingival calculus, biofilm and the carious tissues were removed. The access cavity preparation was completed. The crown-down technique was performed using Gates Glidden and Kerr files with an anatomic diameter compatible to the radicular canal, and the irrigation was performed with 5 mL of 2.5% NaOCl solution between each endodontic file. The working length was established 1 mm short of the radiographic apex. Smear layer was removed by rinsing the canal with 17% ethylene diamine tetra-acetic acid solution, which was left in the canal for 5 min, followed by a final irrigation with 15 mL of 2.5% NaOCl solution. Calcium hydroxide paste with paramonoclorophenol, was inserted into the canal, filling the root canal as temporary medication between the sessions. The coronal sealing was performed using Coltosol, followed by glass ionomer Maxxion R. Seven days later the root canal was filled by the hybrid Tagger technique, with a Mc Spadden condenser.
15956722|NCT03212690|Drug|Local standard of care|Local standard of care will include fluid resuscitation, use of vasopressor drugs and renal support.
15956723|NCT03212690|Procedure|Mechanical ventilation|Mechanical ventilation will be based on volume-assist control mode, with a target tidal volume of 6-8 milliliter per kg (mL/kg) and a target plateau pressure of 30 centimeter of water (cmH2O).
15956724|NCT03212677|Dietary Supplement|Ferrous sulfate|Standard-of-care therapy for iron deficiency anaemia
15956725|NCT03212677|Dietary Supplement|IHAT|IHAT is a nanoparticle composed of three General Regarded As Safe (GRAS) substances, iron hydroxide, tartaric acid and adipic acid. The particle itself resembles the normal metabolite ferritin, which is a larger polyatomic particle. Like ferritin, IHAT can be absorbed by endocytosis, but dissociates within the enterocyte and is subsequently metabolized as ferrous iron.
15956726|NCT03212677|Dietary Supplement|Aspiron|Aspiron is a product of the natural fermentation of Koji (Aspergillus oryzae) in the presence of ferrous sulfate. The iron-rich koji biomass is heated, harvested and dried which results in the inactivation of Koji powder that contains 8-10% iron. Koji (A. oryzae) is widely used for making such foods as soy sauce, tempeh, miso, and for producing food-grade α-amylase, and is considered safe by Joint Food and Agriculture Organization of the United Nations (FAO)/WHO Committee on Food Additives and has been accepted as a GRAS constituent of food.
15956727|NCT03212677|Other|Placebo|Cornstarch
15956728|NCT03212664|Other|exercise|physical therapy exercises
15956729|NCT03212651|Drug|Pembrolizumab|Pembrolizumab 200mg IV infusion
15956730|NCT03212638|Drug|Baricitinib suspension|Administered orally
15956731|NCT03212638|Drug|Baricitinib tablet|Administered orally
15956732|NCT03212625|Drug|Urea Cream 20%|Sorafenib 400mg (twice daily), Spread urea cream (urea 20%)
15956733|NCT03212625|Drug|Placebos|Sorafenib 400mg (twice daily), Spread placebo cream (urea 0%)
15956734|NCT03212612|Diagnostic Test|samples obtained by laparoscopy or punch biopsy for analysis by ELISA|Endometrial samples(1-2 gram) will be separated from each women during proliferative phase(days 5-15) by laparoscopy or punch biopsy and washed several times with 0.9% sterile saline solution to remove any blood from the tissues. The tissue samples will homogenized by tissue homogenizer at 40,000rpm. The supernatant extracts will be collected in Ependorf tubes and frozen at -80°C till analysis by ELISA
15956735|NCT03212599|Drug|Disulfiram|alcohol addicted patients receive an oral Disulfiram application as recrudescence prevention after successful detoxication
15956736|NCT03212586|Drug|BAY1902607|Escalating doses of BAY1902607; single dose administration; different dosage forms (redosing of BAY1902607 at dose group 4 with different formulations; redosing of BAY1902607 solid formulation at dose group 4 together with food)
15956737|NCT03212586|Drug|Placebo|Escalating doses of Placebo; single dose administration; different dosage forms (redosing of Placebo at dose group 4 with different formulations; redosing of Placebo solid formulation at dose group 4 together with food)
15956738|NCT03212573|Combination Product|ERAS protocol|ERAS protocol includes early oral intake and deambulation and multimodal analgesia
15956739|NCT03212573|Combination Product|Standard care|Oral intake and deambulation 24h after surgery and only intravenous analgesia.
15956740|NCT03212547|Behavioral|Verbal Intervention|"Promotion of verbal interventions:
~Detecting whether the infant has social withdrawal.
~The physician will verbally intervene.
~Positive response (+) from the infant, the evaluator will point out this to the parents.
~Negative response (-) from the infant, the evaluator will include the parents in the interaction.
~If he infant establishes positive contact (+) with the parents, he/she will point out this response to them.
~If the infant does not establish positive contact (-)with the parents, repeat step 2.
~If the infant offers a positive response (+) to the second attempt of verbal intervention, the evaluator will point out this response to the parents.
~At the end of each medical check-up, give and explain the ADBB Intervention Sheet."
15956741|NCT03212534|Other|Patient mortality prediction|Healthcare provider is notified of patient mortality prediction.
15956742|NCT03212521|Drug|Glecaprevir/Pibrentasvir|Glecaprevir/pibrentasvir 100 mg/40 mg co-formulated tablets taken orally as 3 tablets once a day.
15956743|NCT03212508|Device|RAM cannula and Hudson prongs|Measuring intraoral pressure using two different nasal interface for applying nasal continuous positive airway pressure
15956744|NCT03212495|Drug|dexamedetomidine|intraarticular injection of 1µg/kg dexametomidine +18ml 0.25%bubivacaine in a total volume of 20 ml.
15956745|NCT03212495|Drug|neostigmine|intraarticular injection of 0.5mg/dose neostigmine +18ml 0.25%bubivacaine in a total volume of 20 ml.
15956746|NCT03212469|Drug|Durvalumab|"Preliminary steps : Safety Runs Safety run of the dual combination Durvalumab as single agent at the selected dose of 1500mg, every 4 weeks (Q4W) from C1D1 up to 13 doses
~Safety run of the triple combination:
~Durvalumab at 1500mg every 4 weeks (Q4W) from C1D1 up to 13 doses,
~Efficacy step
~Durvalumab Q4W + Tremelimumab Q4W for up to 4 doses at the DL defined in safety runs, in conjunction with
~SBRT at C1D15, then
~Durvalumab Q4W alone for up to 9 additional doses"
15956747|NCT03212469|Drug|Tremelimumab|"Preliminary steps : Safety Runs
~Safety run of the triple combination:
~Tremelimumab at 75mg/Q4W for up to 4 doses
~Efficacy step
~Durvalumab Q4W + Tremelimumab Q4W for up to 4 doses at the DL defined in safety runs, in conjunction with
~SBRT at C1D15, then
~Durvalumab Q4W alone for up to 9 additional doses"
15956748|NCT03212469|Radiation|SBRT|"Preliminary steps : Safety Runs
~Safety run of the dual combination:
~SBRT at C1D15.
~Safety run of the triple combination:
~SBRT at C1D15.
~Efficacy step
~Durvalumab Q4W + Tremelimumab Q4W for up to 4 doses at the DL defined in safety runs, in conjunction with
~SBRT at C1D15, then
~Durvalumab Q4W alone for up to 9 additional doses"
15956749|NCT03212456|Drug|opioid-free group|We'll study if the opioid-free anesthesia can reduce the biochemical recurrence of prostate cancer.
15956750|NCT03212456|Drug|Opioid Group|This group will receive fentanyl in the induction of anesthesia.
15956751|NCT03212456|Procedure|transversus abdominal plane block with ropivacaine|The opioid-free group will receive transversus abdominal plane block with ropivacaine 0,375% 20 ml each side
15956752|NCT03212456|Procedure|transversus abdominal plane block with placebo|the non-opioid free group will receive transversus abdominal plane block with physiological solution 0,9% 20 ml each side
15956753|NCT03212443|Procedure|Suprascapular nerve- axillary nerve block combination|In Group B, suprascapular (10 ml of 0.250% bupivacaine ) and axillary block (10 ml of 0.250% bupivacaine) will be performed with ultrasound and nerve stimulator guidance before induction of anesthesia
15956754|NCT03212443|Procedure|Subacromial infiltration|In group A, the surgeon will apply 20 ml of 0.250% bupivacaine to the subacromial region at the end of the procedure
15956755|NCT03212430|Drug|L-kynurenine|intravenous infusion of L-kynurenine to healthy individuals.
15956756|NCT03212417|Other|Educational intervention|Presentation of risk factors, signs and symptoms, and interventions on compassion fatigue
15956757|NCT03212404|Drug|CK-301 (cosibelimab)|CK-301 will be administered in periods of 28-day cycles.
15956758|NCT03212391|Behavioral|Diet|52 weeks of Diet supervised by a dietician
15956759|NCT03212391|Behavioral|Walking|26 weeks supervised Walking 3 times per week, followed by 26 weeks of unsupervised Walking
15956760|NCT03212391|Behavioral|Nordic Walking|26 weeks supervised Nordic Walking 3 times per week, followed by 26 weeks of unsupervised Nordic Walking
15956761|NCT03212378|Other|percutaneous coronary interventions|Percutaneous coronary intervention.
15956762|NCT03212365|Drug|Fixed dose|Participants will receive 40 mg enoxaparin twice daily
15956763|NCT03212365|Drug|Variable dose|Participants will receive 0.5mg/kg enoxaparin twice daily
15956764|NCT03212352|Drug|Mifepristone|Adding 600 mg of Mifepristone to the regular treatment with Misoprostol 800 mcg.
15956765|NCT03212352|Drug|Misoprostol|Regular treatment with Misoprostol 800 mcg.
15956766|NCT03212339|Other|Therapeutic intervention|Therapeutic interventions will be delivered in ten 2-hour sessions over 12-15 weeks, which includes 2 research data collection sessions at the beginning of the study (pre-intervention) and at the end of the study (post-intervention). During the pre-intervention data collection session, participants will be asked to provide demographic information and complete interviews about their past experiences and current experiences as a parent, and their child's current functioning. Parents will also be video recorded interacting with their child for 10 minutes. During the post-intervention data collection session, participants will be asked to complete a similar set of interviews and will also be video recorded interacting with their child for 10 minutes.
15956767|NCT03212326|Drug|Perflutren Lipid Microsphere Intravenous Suspension [DEFINITY]|Perflutren 1.3mL diluted in 50 mL is infused intravenously, and intracardiac echo imaging is recorded to analyze for areas of possible myocardial scar, which is then compared with areas of abnormal electrical signal via direct catheter mapping which is performed during ablation of ventricular tachycardia.
15956768|NCT03212313|Drug|Tozadenant|Two 60 mg tablets for a total single study dose of 120 mg
15956769|NCT03212300|Behavioral|Aerobic Exercise Training (AET)|20 sessions of AET over a 4 week period just prior to surgery
15956771|NCT03212261|Behavioral|3RP-Lymphoma|An adapted version of the Relaxation Response Resiliency Program (3RP) for individuals who have recently completed treatment for lymphoma.
15956772|NCT03212248|Diagnostic Test|Thoracic Ultrasound (TUS)|
15956773|NCT03212235|Radiation|Hypofractionated radiation therapy|Hypofractionated radiation therapy Total dose: 60 Gy (20 fractions / 3 Gy per fraction)
15956774|NCT03212222|Other|Peek Acuity|Cell phone application for visual acuity screening
15956775|NCT03212222|Other|Standard Visual Screening|Visual screening exam conducted in Duke University Eye Center
15956776|NCT03212209|Device|CPAP Fixed Pressure|Continuous positive airway pressure (CPAP) is the gold standard treatment for moderate and severe OSA, and it has been known to apply positive pressure in the upper airways, acting as a pneumatic splint preventing the upper airway collapse during sleep. CPAP C- Flex Plus by Philips - Respironics works just as CPAP Fixed Pressure, but increases the pressure delivered in the begining of inhalation to softens the breathing rhythm of the CPAP user. CPAP with SensAwake by Fisher and Paykel works just as CPAP fixed pressure but when the breathing pattern suggests that patient is awake, a prompt relief in pressure to the lowest most comfortable level is activated, like ramp feature.
15956777|NCT03212196|Procedure|Pancreaticogastrostomy with external drain|"Pancreatico-enteric anastomosis is provided according to the Bassi technique, pancreatic remnant is pushed into the gastric cavity through a posterior gastrotomy. An externalized drain is placed into the main pancreatic duct."
15956778|NCT03212196|Procedure|Pancreaticojejunostomy with transanastomotic drain|Pancreatico-enteric anastomosis is provided through a double-layer, duct-to-mucosa anastomosis with a transanastomotic externalized drain.
15956779|NCT03212183|Behavioral|EPI-TAVIE|ÉPI-TAVIE is a web-based intervention focusing on epilepsy self-management. This interactive session (25 minutes) is facilitated by a virtual nurse.
15956780|NCT03212183|Other|Websites|The conventional websites offers reliable information about epilepsy. Their content were validated by experts.
15956781|NCT03212170|Drug|[18F]Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging|18F-Fluorofuranylnorprogesterone (FFNP) PET/MR Imaging tracer
15956782|NCT03212157|Other|Glucose infusion|Infusion of 20% dextrose (drug) and using this as an imaging tracer in detecting and staging tumours.
15956783|NCT03212157|Diagnostic Test|Magnetic Resonance Imaging (MRI)|MRI scanners (device) use strong magnetic fields, radio waves, and field gradients to generate images of the organs in the body. Specifically using the MRI scanner with the infusion of dextrose in detecting and staging tumours.
15956784|NCT03212157|Diagnostic Test|FDG PET|FDG is a sugar (glucose) labelled with a small amount of radioactivity which goes to parts of the body that use glucose for energy. PET/CT images are acquired on a single scanner. An FDG PET scan can be used to assess the presence, location and severity of cancers.
15956785|NCT03212144|Other|High Intensity Interval Training|Subjects will exercise according the the high intensity aerobic interval training regiment four times a week for four weeks
15956786|NCT03212144|Other|Peanut Consumption|Subjects will consume peanuts twice a day to replace 20% of their daily caloric intake for four weeks.
15956787|NCT03212131|Drug|Somapacitan|3 once-weekly subcutaneous administrations (s.c., under the skin) of somapacitan with a dose of 0.08 mg/kg
15956788|NCT03212118|Behavioral|Treatment as usual (TAU-0)|"The standard NAV procedure, which consists of a telephone call within 8 weeks to an employer who have employees on 100% sick leave, in addition to regular NAV conversations on-demand (not fixed intervals) between the NAV caseworkers and the employees."
15956789|NCT03212118|Behavioral|Structured talks (TAU-2)|Two structured talks (not including elements from motivational interviewing)
15956790|NCT03212118|Behavioral|motivational interviewing (MI)|Two structured talks (must have a valid motivational interviewing content).
15956858|NCT03211494|Device|INTELLiVENT-ASV|INTELLiVENT-ASV, with software 2.60
15956791|NCT03212105|Behavioral|60 Second Video|The mindfulness intervention will be a video-flash found at http://www.pixelthoughts.co. In this exercise patients are asked to write down a concern or worry, and watch it get put into perspective within a 60 seconds time frame.
15956792|NCT03212105|Other|Educational Brochure|The educational pamphlet will contain information about pain and stress, which patients will be able to read within 60 seconds.
15956793|NCT03212092|Dietary Supplement|Multivitamin, mineral & n-3 FA|The 2 multi vitamin capsules with the two multi vitamin softgel capsules will be handed out once a day during a meal by the staff of the care organization. The compliance will be registered
15956794|NCT03212092|Dietary Supplement|Placebo|The placebo of the multi vitamin capsules and the two multi vitamin softgel capsules will be handed out once a day during a meal by the staff of the care organization. The compliance will be registered
15956795|NCT03212079|Behavioral|Mycoach Smart Text|Personalized text messages to you cellphone to help you become more active
15956796|NCT03212079|Behavioral|MyCoach on Amazon Alexa|This is an intelligent voice that you can communicate with via Amazon echo speaker
15956797|NCT03212066|Behavioral|Master Mind|Master Mind is a 25-lesson elementary school mindfulness education substance abuse prevention program. Each lesson takes approximately 15 minutes and is designed to be taught by trained teachers every day for 5 weeks.
15956798|NCT03212053|Biological|biological tests of haemostasis at each consultation (Multiplate, ROTEM, VASP)|Patients will have blood samples at each consultation (2 or 3 sampling tubes) in order to carry out systematically three biological tests
15956799|NCT03212040|Diagnostic Test|needle biopsy|breast biopsy using different needle gauges
15956800|NCT03212014|Other|LSVT-BIG|LSVT BIG can be delivered by a physical or occupational therapist. Treatment is administered in 16 sessions over a single month (four individual 60 minute sessions per week). This protocol was developed specifically to address the unique movement impairments for people with Parkinson disease. The protocol is both intensive and complex, with many repetitions of core movements that are used in daily living. This type of practice is necessary to optimize learning and carryover of your better movement into everyday life!
15956801|NCT03212014|Other|POWER|Power Rehabilitation(PR), a new resistance training regime, can improve in power and independence level of the elderly people. The first word of PR was in brief of Produce Outcome Worthwhile for the Elderly Rehabilitation (POWER)
15956802|NCT03212014|Other|Traditional rehabilitation|traditional exercise models in currently clinical use
15956803|NCT03211988|Drug|Entinostat|Dose is 5 mg orally every week (days 1, 8, 15, and 22) of a 28 day treatment cycle. Study drug should be taken in the morning and on an empty stomach, at least 2 hours after a meal and at least 1 hour before the next meal. Tablets should be taken whole and not crushed.
15956804|NCT03211975|Other|To study the evolution of the prognosis of infectious endocarditis on native valves and on prostheses|To study the evolution of the prognosis of infectious endocarditis on native valves and on prostheses
15956805|NCT03211962|Other|Analysis of urinary levels of TIMP2 and IGFBP7 within 6 hours after cardiac circulatory arrest|Analysis of urinary levels of TIMP2 and IGFBP7 within 6 hours after cardiac circulatory arrest
15956806|NCT03211949|Procedure|axillary block|2 ml of scandicaine 1.5 % is deposited in an inplane technique around the medial antebrachial cutaneous nerve with a 22 G sonoplex needle as a surplus to an axillary block
15956807|NCT03211949|Drug|Scandicaine|2 ml of scandicaine 1.5 % is deposited in an inplane technique around the medial antebrachial cutaneous nerve with a 22 G sonoplex needle as a surplus to an axillary block
15956808|NCT03211936|Procedure|PEEP TITRATED|After titrated peep levels, we choice this level of peep for de group (peep titrated)
15956809|NCT03211936|Device|Use ultrasound|We make a lung ultrasound after we setup a different level of PEEP
15956810|NCT03211936|Device|Impedance tomography|We use the impedance tomography to titrate peep levels, and acquire dates of collapse, hyperdistension and compliance.
15956811|NCT03211936|Other|Best PEEP for less collapse|After titrated PEEP levels we setup the best PEEP the according of tomography impedance
15956812|NCT03211936|Other|PEEP 4|We set the peep level after titrated peep = 4 cmH20.
15956813|NCT03211923|Diagnostic Test|Transcranial magnetic stimulation (TMS)|Single pulse, monophasic transcranial magnetic stimulation
15956814|NCT03211910|Device|SacralSaver|Sacral Savers is a combination of a strong bubble wrap sheet with a fold at the head end and a nylon sham with a pocket into which the bubble wrap sheet is inserted. This combination is then placed under the fitted sheet on the patient's mid back and the pressure exerted by the lower back of the patient is markedly reduced or nearly eliminated (tested and proven using computer models), thereby preventing the onset of pressure ulcers in the sacro-coccygeal area.
15956815|NCT03211910|Other|Standard Care of Treatment|Standard Care of Treatment
15956816|NCT03211897|Drug|Haloperidol Injection|As part of the quality initiative protocol, patients who are treated for acute agitation in the ED will receive haloperidol as their initial sedative agent during the 21 day block. All subsequent agitation medications are at the discretion of the provider.
15956817|NCT03211897|Drug|Ziprasidone Injection|As part of the quality initiative protocol, patients who are treated for acute agitation in the ED will receive ziprasidone as their initial sedative agent during the 21 day block. All subsequent agitation medications are at the discretion of the provider.
15956818|NCT03211897|Drug|OLANZapine Injection|As part of the quality initiative protocol, patients who are treated for acute agitation in the ED will receive olanzapine as their initial sedative agent during the 21 day block. All subsequent agitation medications are at the discretion of the provider.
15956819|NCT03211897|Drug|Midazolam injection|As part of the quality initiative protocol, patients who are treated for acute agitation in the ED will receive midazolam as their initial sedative agent during the 21 day block. All subsequent agitation medications are at the discretion of the provider.
15956851|NCT03211585|Device|Perfecta V-Beam laser|This s a single study and a prototype of the FDA-cleared, flashlamp-pumped pulsed-dye laser, that is currently on the market, that has evolved over almost 25 years of continuous development. The broad-spectrum flashlamp pumps energy into a cavity containing liquid dye. The dye is excited resulting in the emission of 595 nm orange light.
15956852|NCT03211572|Drug|Tamoxifen|Participants will take endocrine therapy for 2 weeks prior to surgery.
15956853|NCT03211559|Other|Exercise|clinical pilates on mat
15956854|NCT03211546|Procedure|Conservative (non-surgical) treatment|Spica cast Traction Traction and spica cast
15956820|NCT03211884|Behavioral|Problem-Solving Thearpy|"The problem-solving therapy (PST)-based intervention consists of nine, 60-90 minute educational sessions conducted face-to-face via the Internet (through video conferencing software) approximately 2 weeks apart. After attending a preliminary 15 minute meet & greet session, participants received written and verbal education about solving everyday problems. Together, the participant and interventionist complete the 7-steps to solve at least one problem together before ending the training. Participants keep a record of their problem-solving efforts between sessions and questions they had related to the application of PST. These records were used as a basis for discussion during the PST training sessions."
15956821|NCT03211871|Drug|Dexmedetomidine|Intraoperative intravenous dexmedetomidine infusion 0,5 mcg/kg/h
15956822|NCT03211871|Drug|Normal Saline Flush, 0.9% Injectable Solution_#1|Intraoperative intravenous normal saline infusion
15956823|NCT03211858|Drug|Insulin aspart|SAR341402 100 units per milliliters (U/mL) (dose range of 1 unit to 80 units) self-administered by SC injection, immediately (within 5-10 minutes) before meal intake. Dose adjusted to achieve a 2-hour postprandial plasma glucose (PPG <10 millimoles/liter [mmol/L] [<180 milligram/deciliter {mg/dL}]) while avoiding hypoglycemia.
15956824|NCT03211858|Drug|NovoLog/NovoRapid|NovoLog/NovoRapid 100 U/mL (dose range of 1 unit to 60 units) self-administered by SC injection, immediately (within 5-10 minutes) before meal intake. Dose adjusted to achieve a 2-hour postprandial plasma glucose (PPG <10 mmol/L [<180 mg/dL]) while avoiding hypoglycemia.
15956825|NCT03211858|Drug|Insulin glargine (HOE901)|Insulin glargine 100 U/mL injected QD subcutaneously consistent with the local label. Doses adjusted to achieve glycemic target for fasting, preprandial plasma glucose between 4.4 to 7.2 mmol/L (80 to 130 mg/dL) without hypoglycemia.
15956826|NCT03211845|Other|Nutritional telemonitoring|Participants receive a weighing scale, pedometer and television channel in order to perform self-measurements and receive guidance on nutrition and physical activity. Nurses use a website in order to receive telemonitoring measurements and decide about proper follow-up. In case of risk of undernutrition, nurses provide personal advice to optimize nutritional status of the participant.
15956827|NCT03211832|Other|Dissemination of public health knowledge|Participating local health departments will help develop and choose dissemination strategies they prefer for their staff working in and supporting diabetes and chronic disease prevention and control to receive. Dissemination strategies may include multi-day in-person training workshops, electronic information exchange modalities, remote technical assistance, and information on ways to enhance organizational climates favorable to evidence-based diabetes prevention and control.
15956828|NCT03211819|Procedure|immediate implant placement|"A prophylactic antibiotic(Flumox 500mg, Egyptian Int. Pharmaceutical Industries Co.,A.R.E.) would be given to the patient 3 days prior to the surgery. Then on the day of surgery, (AK) will extract the remaining root or tooth in an atraumatic procedure using lancet, periotome (Nordent Manufacturing Inc. U.S.A), minimal force and rotational movement.
~After extraction the socket will be examined for intact labial and palatal bone using depth probe. If all walls are intact the socket would be eligible for immediate implant placement."
15956829|NCT03211806|Behavioral|Sedentary Behavior|Messages delivered via smartphone prompting patients to walk after prolonged sedentary behavior bouts are detected via Bluetooth-enabled activity monitor
15956830|NCT03211806|Device|Bluetooth-enabled activity monitor|Monitoring activity using a Bluetooth-enabled activity monitor
15956831|NCT03211793|Drug|Mesenchymal stromal cells|8 intramuscular injections at designated sites in the hand/forearm muscles of the most affected side. Blinded syringes will be used. Injections will be administered by an experienced clinician (plastic surgeon or hand surgeon).
15956832|NCT03211793|Other|Placebo|8 intramuscular injections at designated sites in the hand/forearm muscles of the most affected side. Blinded syringes will be used. Injections will be administered by an experienced clinician (plastic surgeon or hand surgeon).
15956833|NCT03211780|Device|General Electric LOGIQ E9 ultrasound system|Patients will be brought to the operating room in line with standard clinical practice and after esophageal exposure, but before surgical mobilization of the esophagus, shear wave vibrometry and B-mode imaging will be performed after esophageal distension with a fluid filled balloon intra-operatively.
15956834|NCT03211767|Dietary Supplement|Aged garlic extract|Each capsule contains 600mg of aged garlic extract powder
15956835|NCT03211767|Dietary Supplement|Placebo|Each capsule contains cellulose as a filler.
15956836|NCT03211754|Dietary Supplement|walnuts and almonds|The subjects consumed 15g of walnuts and 15g of almonds/day for 8 weeks
15956837|NCT03211741|Drug|Bevacizumab Injection [Avastin]|Bevacizumab 1.25mg/0.05 mL will be injected intravitreally using one 30-gauge x 1/2-inch injection needle vials are for single eye use only.
15956838|NCT03211728|Drug|pregabalin|The intervention group receive pregabalin 150 mg 1 hour before surgery and 12 hours after initial dose.
15956839|NCT03211728|Drug|placebo|The placebo group receive placebo 150 mg 1 hour before surgery and 12 hours after initial dose.
15956840|NCT03211715|Other|questionnaire|Rectal cancer patients who received sphincter saving surgery will be asked to fill up questionnaire related to bowel dysfunction
15956841|NCT03211689|Other|Exercise Program|Participants will utilize the Physitrack exercise program to engage in up to 150 minutes of exercise at a rating of 11-14 on the Borg Rate of Perceived Exertion scale, per week.
15956842|NCT03211676|Device|Theranova-500 dialyzer|hemodialysis with Theranova-500 dialyzer.
15956843|NCT03211676|Device|Elisio-21H|hemodialysis with Elisio-21H dialyzer
15956845|NCT03211650|Drug|hyaluronic Acid + platelet-rich plasma|Intra-articular injections of hyaluronic acid combined with platelet-rich plasma
15956846|NCT03211650|Drug|hyaluronic acid|Intra-articular injections of hyaluronic acid
15956847|NCT03211650|Drug|platelet-rich plasma|Intra-articular injections of platelet-rich plasma
15956848|NCT03211637|Combination Product|Wounds Protocol|Nurses who have been trained to use wound dressing supplies and also on the use of the protocol.
15956849|NCT03211611|Behavioral|Questionnaire given to the two groups|"Questionnaire given to the two groups :
~Patients with BRCA ½ mutation GP"
15956850|NCT03211598|Procedure|TACE with Surefire|Subjects that consent to the study will receive their TACE procedure through the Surefire Infusion System
15956855|NCT03211546|Procedure|Surgical treatment|Elastic Stable Intramedullary Nailing (ESIN) Conventional locking intramedullary nail Plating External fixation
15956859|NCT03211494|Other|Conventional lung protective ventilation|Lung protective ventilation according to the ARDSnet guidelines
15956860|NCT03211468|Behavioral|Clinical intervention program to prevent eating disorders|See previous
15956861|NCT03211455|Drug|Lidocaine|intravenous lidocaine versus placebo
15956862|NCT03211455|Drug|isotonic saline|intravenous isotonic saline
15956863|NCT03211442|Radiation|Radiotherapy|Breast cancer patients treated with radiotherapy
15956864|NCT03211429|Behavioral|Cognitive behavioural therapy|The program aims to teach participants how to deal with their concerns about falls and related avoidance of activity
15956865|NCT03211429|Other|Tai chi|Tai Chi training in the Yang style of 24 movement
15956866|NCT03211429|Other|Postural control exercise|Individually adjusted progressive and specific postural control training,
15956870|NCT03211403|Drug|SHR4640|SHR4640 or placebo once daily for a week
15956871|NCT03211390|Diagnostic Test|Neurological Examination|The subject will undergo elements of the neurological examination during which the movement disorders neurologist will look specifically for the presence of spasticity. If spasticity is found to be present during the examination, the neurologist will rate the severity of the spasticity in all affected limbs and record whether they would recommend treatment for spasticity, and if so, which treatment(s) they believe would be beneficial for the subject.
15956872|NCT03211390|Diagnostic Test|Teleneurological Examination|A Vanderbilt neurologist will examine all consented residents using a telemedicine platform, with the assistance of a nurse at the subject's bedside. The neurologist will guide the nurse to perform elements of a physical examination to determine if a referral to a movement disorders neurologist is required for a spasticity consultation.
15956873|NCT03211364|Other|Glenohumeral mobilization|Comparing the effect of angular mobilization in frontal or scapular plane and of providing soft tissue techniques on hemiplegic shoulder range of motion and pain.
15956874|NCT03211364|Other|Scapular mobilization|
15956875|NCT03211351|Drug|Liposic|one eye of the participant recieved Lipoic
15956876|NCT03211351|Drug|Tears Naturale Forte|the other eye of the participant recieved Tears Naturale Forte
15956877|NCT03211338|Biological|Culture with progesterone|Progesterone, a steroid hormone will be cultured with placental IMC cells or peripheral blood CD14+ monocyte cells
15956878|NCT03211338|Biological|Culture without progesterone|Culture of placental IMC cells or peripheral blood CD14+ monocyte cells without progesterone
15956879|NCT03211338|Biological|Culture with growth factors|Culture of placental IMC cells with growth hormones only and analysis
15956880|NCT03211325|Procedure|Biopsy|
15956881|NCT03211286|Drug|Tranexamic Acid|1 g of intravenous tranexamic acid in 100 mL of saline solution
15956882|NCT03211286|Drug|Saline Solution|saline solution 100 mL intravenous
15956883|NCT03211260|Device|EQUISTASI|Equistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive four patches to be placed on both legs for 4 weeks.
15956884|NCT03211247|Biological|Viaskin Peanut 250 mcg|Viaskin Peanut 250 mcg, once daily
15956885|NCT03211247|Biological|Viaskin Peanut 100 mcg|Viaskin Peanut 100 mcg, once daily
15956886|NCT03211247|Biological|Placebo|Placebo patch, once daily
15956887|NCT03211234|Drug|2.0 mg DE-122 Injectable Solution + Lucentis|Subjects will receive 6 monthly intravitreal injections of low dose DE-122 in the study eye, in combination with Lucentis.
15956888|NCT03211234|Drug|4.0 mg DE-122 Injectable Solution + Lucentis|Subjects will receive 6 monthly intravitreal injections of high dose DE-122 in the study eye, in combination with Lucentis.
15956889|NCT03211234|Drug|Lucentis|Subjects will receive 6 monthly intravitreal injections of Sham in the study eye, in combination with Lucentis.
15956890|NCT03211221|Device|rTMS (repetitive transcranial magnetic stimulation)|rTMS is a non-invasive neuromodulation technique that is able to modulate cortical and subcortical function with the use of rapidly changing electromagnetic fields generated by a coil placed over the scalp (George and Post, 2011). Depending on the parameters of stimulation, rTMS can either decrease or increase cortical excitability in relatively focal areas, with frequencies < or = 1 Hz (low frequency rTMS or LF-rTMS) being usually inhibitory and higher frequencies (> or = 5 Hz; high frequency rTMS or HF-rTMS) being usually excitatory (Rosa and Lisanby, 2012). Moreover, rTMS has proven to have long-lasting effects on brain neuroplasticity through different mechanisms (e.g. by inducing long-term potentiation, increasing several neurotrophic factors etc.) (Chervyakov et al., 2015).
15956891|NCT03211195|Drug|Sotagliflozin (SAR439954)|"Pharmaceutical form: tablet
~Route of administration: oral"
15956892|NCT03211182|Behavioral|lifestyle modification intervention|healthy lifestyle education and individualized counseling by well-trained case manager. The main goals of the lifestyle intervention included regular moderate intensity physical activity 150 min per week or more, and dietary strategies which reduce the risk of developing diabetes. The dietary suggestion was modified by Dietary Approaches to Stop Hypertension (DASH) Diet. Participants with BMI>= 24 kg/m2 were encouraged to gradually lose weight at a rate of 0.5-1.0 kg per week until they achieved a BMI of 24 kg/m2.
15956893|NCT03211169|Procedure|Biopsies of bile duct stricture with pediatric biopsy forceps|Biopsies of the stricture will be taken to evaluate diagnostic yield of Pediatric Biopsy Forceps
15956894|NCT03211169|Procedure|Biopsies of bile duct stricture with cholangioscopy-directed biopsies|Biopsies of the stricture will be taken to evaluate diagnostic yield of cholangioscopy-directed biopsies
15956895|NCT03211156|Drug|Amoxicillin|Amoxicillin is an aminopenicillin antibiotic
15956896|NCT03211156|Other|Placebo|Placebo
15956897|NCT03211143|Drug|CKD-381|Test drug: CKD-381
15956898|NCT03211143|Drug|Nexium|Reference drug: Nexium
15956899|NCT03211130|Behavioral|SystemCHANGE™|During the intervention phase, the PI will visit both groups of participants at home at baseline and telephone them three times (day 3 ±2 days and months 1 and 2). Refer to tables 1 and 2 for intervention details. Treatment participants will implement SystemCHANGE™ activities related to medication taking with the assistance of the PI while attention-control participants will receive patient education materials on stroke. Perceived health data will be collected during the intervention phase. A 1-month maintenance phase follows the intervention phase. Electronic medication monitoring continues, but no intervention is delivered to either group.
15956900|NCT03211130|Behavioral|Attention-Control|An experienced stroke nurse will deliver the attention control intervention. Table 3.2 shows the 2-month attention-control intervention. The stroke materials were developed by the Saint Luke's Marion Bloch Neuroscience Institute and are given to every stroke patient prior to dismissal. The PI will call participants at day 3 ±2 days, and months 1 and 2 to review chapter(s) from the book and answer questions about it. Interval, frequency, and setting are all exactly the same for the intervention and control groups. If the control participant raises questions about medications or medication-taking, PI will refer them to their Neurologist.
15956901|NCT03211117|Drug|Docetaxel|Given IV
15956902|NCT03211117|Drug|Doxorubicin Hydrochloride|Given IV
15956903|NCT03211117|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
15956904|NCT03211117|Other|Laboratory Biomarker Analysis|Correlative studies
15956905|NCT03211117|Biological|Pembrolizumab|Given IV
15956906|NCT03211117|Procedure|Therapeutic Conventional Surgery|Undergo surgery
15956907|NCT03211104|Dietary Supplement|curcumin|
15956908|NCT03211104|Dietary Supplement|Placebo|
15956909|NCT03211078|Procedure|super-D ENB guided-PDT|PDT with super-D EBN localization will be given for treating the target lung lesion. Intrvenous photofrin (2mg/kg) will be given 48 hours before intervention. After localization of the tumor by ENB, a 630nm of light will be give for the lesion with the dosage of 2oo J/cm. Intravenous general anesthesia and endobronchial intubation will be performed under the whole procedure.
15956910|NCT03211065|Drug|20% subcutaneous immunoglobulin|Subcutaneous Immunoglobulin
15956911|NCT03211052|Drug|TAK-700 and LHRH agonist|TAK-700 for 6 months 300mg BD with Leuprorelin Acetate Injections prior to planned prostatectomy
15956912|NCT03211052|Procedure|prostatectomy|SURGICAL REMOVAL OF THE PROSTATE
15956913|NCT03211039|Genetic|Genomic sequencing and molecular diagnostic results, if any.|Patients and their families will be randomized to either receive whole genome sequencing or whole exome sequencing.
15956914|NCT03211026|Other|No intervention|No intervention
15956915|NCT03211013|Drug|Oxytocin|single-dose administration of OT nasal spray, complete computer-based tasks post-dose for approximately 1 hour
15956916|NCT03211013|Drug|Placebos|single-dose administration of placebo nasal spray, complete computer-based tasks post-dose for approximately 1 hour
15956917|NCT03210987|Procedure|patient case presentation bedside|Patient case presentation in absence or presence of Patient at bedside.
15956918|NCT03210987|Procedure|patient case presentation Outside-the-room|Patient case presentation Outside-the-room.
15956919|NCT03210961|Drug|PF-06826647 tablet|PF-06826647 tablet for oral administration
15956920|NCT03210961|Drug|PF-06826647 oral suspension|PF-06826647 suspension for oral administration (oral suspension to be administered to the 3mg starting dose cohort only)
15956921|NCT03210961|Other|Placebo oral solution/suspension|placebo oral solution for the single ascending dose, first cohort only
15956922|NCT03210961|Other|Placebo tablet|Matching placebo tablet
15956923|NCT03210948|Device|RTE-guided EUS-FNA|Fine needle aspiration with 25 gauge needle under RTE-guidance
15956924|NCT03210948|Device|Conventional EUS-FNA|Fine needle aspiration with no RTE guidance
15956925|NCT03210922|Device|Miami cervical collar|Collar group is put on the Miami cervical collar.
15956926|NCT03210909|Drug|BMS-986231|BMS-986231
15956927|NCT03210896|Dietary Supplement|Orange juice|Sub group I will drink Orange juice and have repeat measures.
15956928|NCT03210870|Behavioral|nutritional education classes|The objective to be accomplished through the completion of a nutritional education program for pregnant women that incorporates the biopsychosocial principles of the Satter Eating Competence Model. Emphasizing healthy food choices and improve eating competency.
15956929|NCT03210857|Other|apnea performing|"The included subjects will make an apnea of two minutes or more, sitting on a chair with cold strips on the face, initially with the head in neutral position. Then, when they feel the end of their apnea, they will have to raise their left hand to signal it to the Doppler manipulator, who will then realize the apnea reference measurement.
~As soon as this is done, the subjects will be asked to perform an extension of the neck, so as to look at the ceiling. A final measurement will then be made in apnea, the head always in extension. Subjects then resume their breathing in this same position. A final measurement will then be made."
15956930|NCT03210844|Procedure|Surgical approaches of total hip arthroplasty|Surgical approaches of total hip arthroplasty
15956931|NCT03210818|Device|Extra-corporeal membrane oxygenation life support|Adjustment of blood flow of extra-corporeal membrane oxygenation life support
15956932|NCT03210805|Dietary Supplement|Omega-3 Polyunsaturated Fatty Acids Supplementation|28 days of a commercially available supplement. 4 capsules per day.
15956933|NCT03210792|Device|Application of Rib Splint|Investigators randomly apply handmade Rib Splint or manufactured Rib Splint to subjects.
15956934|NCT03210779|Dietary Supplement|L. reuteri DSM 17938/ATCC PTA|Ingestion of active lozenge twice daily for 16 days and topical application of active oil once daily for 8 days
15956935|NCT03210779|Dietary Supplement|Placebo|Ingestion of inactive lozenge twice daily for 16 days application of inactive oil once daily for 8 days
15956936|NCT03210766|Drug|Nabilone|
15956937|NCT03210766|Drug|THC/CBD|
15956938|NCT03210740|Drug|AM001 Cream, 7.5%|Active Cream
15956939|NCT03210740|Drug|Vehicle Cream|Placeo
15956940|NCT03210727|Behavioral|Ready to CARE program|"The intervention is built upon a model of caregiver well-being that identifies four domains of quality of life: physical, psychological, social, and spiritual well-being. For each domain, there are stressors (i.e., factors that make it hard to be a caregiver) and buffers (i.e., factors that help people be effective caregivers). Our Ready to CARE intervention begins by presenting caregivers with the model in order to generate a profile of personal stressors and buffers. From there, caregivers select from a menu of strategies that can be used to minimize stressors and create buffers in their daily life. The investigators will have six 45-minute sessions with the caregivers that will primarily occur while the patient is admitted for stem cell reinfusion."
15957316|NCT03207607|Other|Maltodextrin snack|Isovolumetric (238.4g) gel snack with maltodextrin (271.8kcal)
15956944|NCT03210701|Other|A HIV POCT program adapted for & provided by community pharmacists|Using a Type II hybrid Implementation-Effectiveness study design investigators will assess the implementation and effectiveness of a multi-faceted, integrated, contextualized model of HIV POCT in pharmacies in urban and rural settings in NL and AB, Canada. This design will be flexible, responsive and capable of capturing changing elements at multiple points in time. A mixed methods approach will be used to assess Implementation and Effectiveness aims.
15956945|NCT03210688|Drug|Prednisolone|Tablet prednisolone
15956946|NCT03210688|Drug|Alfacalcidol|Capsule alfacalcidol 0,5 microgram/day
15956947|NCT03210675|Diagnostic Test|Polysomnography (PSG)|PSG will be perfomed every 6 months in the Study group from the age of 6 months to 3 years
15956948|NCT03210662|Radiation|External Beam Radiation Therapy|Undergo EBRT
15956949|NCT03210662|Biological|Pembrolizumab|Given IV
15956950|NCT03210649|Drug|CKD-519|Part 1 : CKD-519(100mg x 4 Tablets) for D1 Part 2 : CKD-519(100mg x 4 Tablets) for D1~D14
15956951|NCT03210649|Drug|Placebo|Part 1 : CKD-519 placebo(100mg x 4 Tablets) for D1 Part 2 : CKD-519 placebo(100mg x 4 Tablets) for D1~D14
15956952|NCT03210636|Device|LapSpace|use of atraumatic laparoscopic retractor for patients undergoing laparoscopic surgery
15956953|NCT03210623|Device|stent retriever(TonbridgeMT)|mechanical thrombectomy with stent retriever(TonbridgeMT), digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging (MRI), diffusion weighted imaging (DWI)
15956954|NCT03210623|Device|Solitaire™|mechanical thrombectomy with Solitaire™ , digital subtraction angiography(DSA), computed tomography(CT), magnetic resonance imaging(MRI), diffusion weighted imaging(DWI)
15956955|NCT03210610|Diagnostic Test|colchicine level measurement|levels of colchicine will be measured in FMF patients taking colchicine
15956956|NCT03210597|Other|Exercise|The subjects performed training in aquatic environment
15956958|NCT03210558|Drug|Testosterone cream 1% (Andro-Feme® )|Testosterone cream 10 mg (1 ml) daily, supplied every evening via a dose applicator to the upper outer thigh for 10 weeks.
15956959|NCT03210558|Drug|Placebo cream|Placebo cream (1 ml) daily, supplied every evening via a dose applicator to the upper outer thigh for 10 weeks.
15956960|NCT03210545|Drug|Betamethasone|A cross-over study where patients with Addison´s disease will undergo two treatment periods where their usual hydrocortisone replacement therapy will be replaced by the glucocorticoid betamethasone in physiological and supra physiological doses. A wash-out period of 2-5 weeks in-between the treatment periods will be carried out where participants intake their usual hydrocortisone replacement therapy.
15956961|NCT03210532|Drug|Telmisartan + Amlodipine + Rosuvastatin|Telmisartan + Amlodipine + Rosuvastatin + Telmisartan placebo
15956962|NCT03210532|Drug|Telmisartan + Amlodipine|Telmisartan + Amlodipine + Rosuvastatin placebo + Telmisartan placebo
15956963|NCT03210532|Drug|Telmisartan + Rosuvastatin|Telmisartan + Amlodipine placebo + Rosuvastatin + Telmisartan placebo
15956964|NCT03210519|Dietary Supplement|Eleutherococcus senticosus|taken orally once/day for 90 days
15956965|NCT03210519|Other|Placebo|taken orally once/day for 90 days
15956966|NCT03210506|Drug|Peginterferon Alfa-2a|patients untreated in immune-active phase were given subcutaneous injection of Peginterferon Alfa-2a with starting dose of 180 mg/weekly in experiment group.
15956967|NCT03210493|Drug|Peginterferon Alfa-2a|patients untreated in immune-active phase were given subcutaneous injection of Peginterferon Alfa-2a with starting dose of 180 mg/weekly in experiment group
15956968|NCT03210480|Drug|Lithium sulphate prolonged-release 660 mg|Oral administration of one tablet once or twice daily (one tablet in the morning and one tablet in the evening) or two tablets in a single dose (two tablets in the evening) of Lithium sulphate 660 mg (Lithium sulphate dose will be individualised for each patient according to the relevant SmPC). Treatment duration: 3 months.
15956969|NCT03210480|Drug|Lithium carbonate immediate-release 150 mg and 300 mg|Oral administration of 300-1800 mg daily divided into 2-6 doses of Lithium carbonate capsules (Lithium carbonate dose will be individualised for each patient according to the relevant SmPC). Treatment duration: 3 months.
15956970|NCT03210454|Other|Smallholder Marketing|The smallholder marketing intervention involves product purchasing (e.g., bananas, beans, goats, eggs) from smallholder farmers' associations through WFP's large procurement procedures. WFP is will also provide technical training on topics such as sustainable farming practices, quality control, and business practices.
15956971|NCT03210454|Other|Intimate Partner Violence (IPV) Prevention Training|IPV prevention training involves 24 hours of gender training (gender equality and rights, economic empowerment, gender-based violence prevention), and 8 hours of nutrition and food security training (with a focus on gender).
15956972|NCT03210415|Other|Observational Study Model|There is no intervention for the study.
15956973|NCT03210402|Device|Elevated night pacing on|Device will be programmed to 100 beats per minute (bpm) for five hours during normal sleep times
15956974|NCT03210402|Device|Elevated night pacing off|Device will be programmed to normal lower rates
15956975|NCT03210389|Drug|Lobaplatin|Patients enrolled will receive lobaplatin 30mg/m2 d1+ 5-FU 0.5g/m2/d d2-5 in every 21days. 4-6 cycles of chemotherapy are recommended.
15956976|NCT03210376|Drug|Deep Neuromuscular Blockade (NMB)|Deep Neuromuscular Blockade (NMB) given during surgery.
15956977|NCT03210376|Drug|Moderate Neuromuscular Blockade (NMB)|Moderate Neuromuscular Blockade (NMB) given during surgery.
15956978|NCT03210376|Drug|Sugammadex|4 mg/Kg, intravenously as a single bolus injection after surgery.
15956979|NCT03210376|Drug|Neostigmine|70 mcg/Kg up to a total of 5 mg, intravenously slowly over a period of at least 1 minute after surgery.
15956980|NCT03210376|Behavioral|Pain Assessment|Pain assessment done at about 15, 45, and 90 minutes after surgery.
15956981|NCT03210363|Other|Human Biological samples|Blood sample
15956982|NCT03210350|Diagnostic Test|Optic nerve sheath diameter|Optic nerve sheath diameter measurement using ultrasound
15956983|NCT03210337|Drug|A-101 Topical Solution|A-101 Topical Solution
15956984|NCT03210337|Drug|A-101 Vehicle Solution|A-101 Vehicle Solution
15957015|NCT03210064|Drug|5-fluorouracil|5-Fluorouracil 400mg/m2 iv d1，2400mg-3000mg/m2 civ 46h,q2w.5-Fluorouracil derivatives(Capecitabine 1000mg/m2 bid po d1-d14 q3w.S1 40mg/m2 bid po d1-d14 q3w).
15956985|NCT03210324|Drug|Mifepristone tablets|Daily 10mg, Po, Qd, each 10mg/tablets。Start from 1 to 3 days of the menstruation, take 1 tablet after 2 hours of fasting, and no eating for 2 hours after taking the pill. Group A and group B: treatment for 12 weeks, Group C: treatment for 24 weeks.
15956986|NCT03210311|Device|compression|a compression stocking is worn, a garment compression class 2, flat knitted
15956987|NCT03210298|Combination Product|PIPAC|A chemotherapeutic solution is aerosolized into the expanded abdominal cavity during laparoscopy, under pressure. This allows a relatively homogeneous repartition of the drug and an effective tissue penetration.
15956988|NCT03210285|Diagnostic Test|Whole exome sequencing|Whole exome sequencing
15956989|NCT03210272|Drug|Placebo|Tablet
15956990|NCT03210272|Drug|BI 1358894|Tablet
15956991|NCT03210272|Drug|BI 1358894 (Test)|Fasting state
15956992|NCT03210272|Drug|BI 1358894 (Reference)|Fed state
15956993|NCT03210259|Drug|Humira®|Duration - 58 weeks
15956994|NCT03210259|Drug|BI 695501|Duration - 58 weeks
15956995|NCT03210246|Drug|Vilaprisan (BAY 1002670)|Multiple doses of Vilaprisan for 3 cycles of 28 days each and 7 additional doses on the 7 days after cycle 3.
15956996|NCT03210246|Drug|Vilaprisan Placebo|Multiple doses of placebo for 3 cycles of 28 days each and 7 additional doses on the 7 days after cycle 3.
15956997|NCT03210246|Drug|Microgynon|Multiple doses of Microgynon for 3 cycles of 21 days each (day 1-21)
15956998|NCT03210246|Drug|Microgynon Placebo|For the treatment cycle 1-3, 7 doses of Microgynon placebo on Day 22-28 per cycle and after 3 treatment cycles 7 additional doses of Microgynon placebo on the 7 days after cycle 3 (day 84 - 91).
15956999|NCT03210233|Procedure|Blood test, skin testing and challenge testing.|Skin Prick Testing (SPT) and Intradermal Testing (IDT). We will follow the STARD framework for reporting studies of diagnostic accuracy
15957000|NCT03210220|Procedure|Pecs II block|After identifying the axillary vein and artery, the ultrasound probe was positioned inferio-laterally, between the 3rd and 4th ribs, and then the pectoralis major and minor, and serratus anterior muscles were confirmed. The needle was advanced in a medio-lateral direction in-plane view of the ultrasound. For the Pecs II block, a total 30 mL of 0.5% ropivacaine was injected. First, the needle tip was advanced into the fascia between the pectoralis major and minor muscles and 10 mL of 0.5% ropivacaine was injected. Thereafter, the needle tip was advanced into the tissue plane between the pectoralis minor and serratus anterior muscles, and 20 mL of 0.5% ropivacaine was injected in a similar manner.
15957001|NCT03210207|Procedure|GASTROPLICATURE|All procedures were performed by a single surgeon. All patients underwent 2-row gastric plication. Dissection was started at the greater curvature of the stomach in contact to the gastric wall from prepyloric area to 2-cm proximal to the Hiss angle preserving the anatomy of Hiss angle. All vessels along the greater curvature were separated using LigaSure (Covidien, Mansfield, MA, USA). The greater curvature (from the perimeter) was invaginated using 2 rows of 00 prolene or 00 nylon sutures. Two layers of plication were performed with continuous sutures with 1 surgical sting in all patients to prevent any displacement of inverted folds such as eversion outside or intussusception into esophagus or pylorus. All sutures were extramucusal to avoid their absorption by gastric acid. Finally, a tube shaped stomach was achieved in which the greater curvature was inverted in to the stomach.
15957002|NCT03210194|Behavioral|Standard Neonatal Resuscitation Training|Theoretical and practical training on basic and advanced neonatal resuscitation skills, directed to personnel from remote health centers using Standard Training
15957003|NCT03210194|Behavioral|MP-ICT Neonatal Resuscitation Training|Theoretical and practical training on basic and advanced neonatal resuscitation skills, directed to personnel from remote health centers using Information and Communication Technologies
15957004|NCT03210181|Other|Superficial cervical plexus block|A nerve stimulator is used to guide the superficial cervical block. The nerve stimulator needle is first passed over the skin after aseptic preparation from the distal to proximal part of the posterior border of the sternocleidomastoid. Upon contraction of the levator scapulae, a mark is placed and the skin is infiltrated with 1 ml lidocaine 1%. A 22-G, 2.5 cm nerve stimulator needle is subsequently advanced through the skin by 0.5-1 cm depending on patient's weight while passing 5-8.5 mA current at 1 Hz. Then, the stimulating current is reduced to 0.5-0.6 mA while maintaining muscle contraction. At this point, 3-5 ml of the anesthetic mixture is injected.
15957005|NCT03210181|Other|Placebo|Patients will receive an equivalent volume of normal saline
15957006|NCT03210168|Other|BioFe Medical Food|BioFe is comprised of cultured nutritional/Baker's yeast (Saccharomyces cerevisiae) with high levels of Ferritin/Iron complex, pasteurized, and dried
15957007|NCT03210155|Device|Alpha-Stim AID CES (Active Comparator)|The Alpha-Stim® AID CES device delivers a mild electrical current (100-500 µA) to the brain via ear clips electrodes. The treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks at 0.5 Hz. 50% duty cycle with a fixed current of 100 µA (subsensory level).
15957008|NCT03210155|Device|Alpha-Stim AID CES (Sham Comparator)|The Alpha-Stim® AID CES sham device is inactive and does not emit electrical current to the brain via ear clip electrodes. The sham treatment regimen is one daily 60 minutes Alpha-Stim® CES treatment using ear clip electrodes for 6 weeks.
15957009|NCT03210142|Procedure|Transvenous hypoglossal nerve stimulation|Transvenous hypoglossal nerve stimulation to open upper airway.
15957010|NCT03210129|Behavioral|Motivational interviewing|"the patients of the motivational interviewing group will receive 12 motivational interviewing sessions within 12 weeks: 2 face-to-face sessions and 10 phone call sessions. The first and the seventh motivational interviewing sessions will be face-to-face sessions. An intervention is considered valid if a minimum of 10 sessions has been completed. The face-to-face motivational interviewing sessions will be administered at the Luxembourg Institute of Health (Strassen, Luxembourg). They generally last up to 30 minutes, while the motivational interviewing phone calls generally last up to 15 minutes. Thereby, patients in the motivational interviewing group will receive a total of approximately 3.5 hours of contact time over a period of 12 weeks.
~Motivational interviewing techniques will explore self-assessed confidence, ambivalence, and personal values concerning changes in active lifestyle."
15957011|NCT03210103|Radiation|Radiation|Standard of Care: Radiation +/- Chemotherapy
15957012|NCT03210103|Procedure|Transoral Surgery (TOS) + Neck Dissection|Transoral Surgery (TOS) + Neck Dissection (plus radiation, if required)
15957013|NCT03210077|Device|Monitoring|Monitoring
15957014|NCT03210064|Drug|Apatinib|Apatinib Mesylate Tablets 500 mg qd po
15957016|NCT03210051|Device|Remote ischemic conditioning|RIC is a physical strategy performed by an electric autocontrol device with cuffs placed on bilateral arms and inflated to 200 mmHg for 5-min followed by deflation for 5-min, the procedures is performed repeatedly for 5 times.
15957017|NCT03210051|Procedure|Endovascular treatment|Endovascular treatment include strategies that used to recanalize the occluded artery. Strategies often used include thrombectomy, intra-arterial thrombolysis, stenting and balloon angiography.
15957018|NCT03210038|Drug|Lidocaine|Pad soaked with lidocaine gel (Esracaine) left on the introitus for 5 minutes
15957019|NCT03210038|Drug|Water|Water based non-anesthetic lubricant gel left on the introitus for 5 minutes.
15957020|NCT03210025|Drug|BF-Methyldopa 250mg Tablet|BF-Methyldopa 250mg Tablet is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
15957021|NCT03210025|Drug|Metopa Tab 250mg|Metopa Tab 250mg is manufactured by APT
15957022|NCT03210012|Diagnostic Test|Transthoracic echocardiography|Diagnostic test done prior and after the dive
15957023|NCT03210012|Diagnostic Test|Blood samples|Diagnostic test done prior and after the dive
15957024|NCT03209986|Procedure|mesenchymal stem cell transplantation via peripheral vein|1x10E6 MSCs/kg body weight will be administered via peripheral vein for 3 times at week 0, 4 and 8
15957025|NCT03209986|Other|mesenchymal stem cell|mesenchymal stem cell infusion produced by Cell products of National Engineering Research Center(short for CPNERC), Tianjin, China
15957026|NCT03209973|Drug|Tislelizumab|Administered as specified in the treatment arm
15957027|NCT03209960|Diagnostic Test|Bedside Referral Tool|Two Vanderbilt primary care providers (a nurse practitioner and a primary care physician) will examine all consented residents. Each primary care provider will perform elements of a physical exam guided by the bedside referral tool to determine if a referral to a movement disorders neurologist is required for a spasticity consultation.
15957028|NCT03209960|Other|Neurological Examination|The subject will undergo elements of the neurological examination during which the movement disorders neurologist will look specifically for the presence of spasticity. If spasticity is found to be present during the examination, the neurologist will rate the severity of the spasticity in all affected limbs and record whether they would recommend treatment for spasticity, and if so, which treatment(s) they believe would be beneficial for the subject.
15957029|NCT03209947|Diagnostic Test|Ulnar nerve Ultrasound|No drug and no placebo were used in this arm. Patients were followed by Ultrasound approach by measure of ulnar nerve surface
15957030|NCT03209908|Drug|Tenofovir Disoproxil Fumarate|Tenofovir Disoproxil Fumarate was used for the experimental group of pregnancy women in the 32 weeks during pregnancy
15957031|NCT03209895|Dietary Supplement|Joint Health Product|Krill oil, Astaxanthin, Hyaluronic Acid Formulation, 353 mg per day; Softgel capsule
15957032|NCT03209895|Dietary Supplement|Placebo|Palm oil Softgel capsule
15957033|NCT03209895|Dietary Supplement|Glucosamine / Chondroitin|Glucosamine 1500 mg, Chondroitin 1200 mg per day
15957034|NCT03209882|Device|TILS|Continuous-wave laser of a specific wavelength (1064 nm) was administered to the participants' right forehead for 8 minutes. The laser power was 3.4 Watts.
15957035|NCT03209882|Device|sham|The sham session consisted of administering the same laser to the participants' right forehead for totally 8 minutes. However, the laser power was turned to be 0 Watts.
15957036|NCT03209869|Biological|Ex vivo Expanded and Activated Haploidentical Donor NK Cells|Haploidentical donor NK cells that are expanded and activated under current GMP conditions using K562-mbIL15-41BBL.
15957037|NCT03209869|Biological|Hu14.18-IL2|The immunocytokine, hu14.18-IL2, is a fusion protein comprised of one molecule of the anti-GD2 humanized monoclonal antibody, hu14.18, fused to two molecules of the cytokine, interleukin-2.
15957038|NCT03209856|Drug|Vitamin D|Vitamin D supplement will be given. Then, it will be maintained if pregnancy occurred
15957039|NCT03209843|Procedure|Percutaneous recanalization of chronic total occlusion|Percutaneous recanalization of chronic total occlusion followed by immediate systematic coronary optical frequency domain imaging (OFDI) at inclusion. Intra-individual post stenting assessment of reendothelialization with a second coronary angiography with OFDI analysis at 3 months.
15957040|NCT03209830|Drug|OSU 6162|All patients will receive a dose of OSU6162 15 mg BID x 2 per day. The expected duration of therapy is 12 weeks. After 1 week of treatment, patients who do not respond to treatment will have their dose increased to maximum 30 mg BID x 2 per day.
15957041|NCT03209830|Drug|Placebo Oral Tablet|All patients will receive a dose of placebo 15 mg BID x 2 per day. The expected duration of therapy is 12 weeks. After 1 week of treatment, patients who do not respond to treatment will have their dose increased to maximum 30 mg BID x 2 per day.
15957042|NCT03209817|Dietary Supplement|Red cherry tomato|300 grams of cherry tomatoes per day for four weeks (each)
15957043|NCT03209817|Dietary Supplement|Yellow cherry tomato|300 grams of cherry tomatoes per day for four weeks (each)
15957044|NCT03209804|Procedure|hybrid operating techniques|A one-stage cooperation of existing endovascular interventional techniques and microsurgical techniques, including microsurgical resection, endovascular embolization, balloon occlusion.
15957045|NCT03209791|Other|Biopsies|Biopsy will be done on the Vastus Lateralis muscle in all groups
15957046|NCT03209778|Other|Patients with Schizophrenia|Patients with schizophrenia or schizoaffective disorder according to DSM-V criteria
15957047|NCT03209765|Other|WhatsApp reminder|An interactive WhatsApp reminder to return to the centre for taking faecal tubes for screening
15957048|NCT03209739|Other|WhatsApp reminder|An additional WhatsApp reminder with same content of the written instruction and a video of explanation of bowel preparation by a nurse 4 days prior colonoscopy
15957049|NCT03209713|Behavioral|HPV Vaccine Education|A one on one twenty-minute parental educational program (in-person or over the phone) providing facts about HPV, HPV-related cancers, and the HPV vaccine.
15957083|NCT03209453|Other|family work shop|Children with developmental delays, under regular rehabilitation programs, participate 6 sessions of family work shop The family work shop had 6 families in one course, 2 hours per week, for a total of 6 weeks.
15957084|NCT03209440|Behavioral|Dignity Therapy - Nurse Led|The nurse-led intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience.
15957050|NCT03209713|Behavioral|Text Messaging Reminder|Participants will receive a text message reminding them of their child's vaccination eligibility once a week, starting one week after participating in the education session (in-person or over the phone). All participants randomized to the text message reminder arm will receive a welcome text message from the automated web-based text messaging service, Mosio, within 72 hours from registration. One week after receiving the welcome text message, they will receive the first weekly text messages reminding them of their child's eligibility for the first dose HPV vaccine. These weekly reminders will occur until uptake of the first dose of the vaccine is reported (through self-report outcome survey completion or submission of the HPV vaccination card/child's official immunization card) or for up to 12 weeks
15957051|NCT03209700|Drug|MSC-AFP|Eligible patients will be treated with a fistula plug that has been coated with autologous mesenchymal stromal cells.
15957052|NCT03209687|Drug|human menopausal gonadotropin|Merional injections will be given to participants after ovum pickup in in-vitro fertilization cycles
15957053|NCT03209674|Procedure|Cardiothoracic surgery|Cardiac or thoracic procedure
15957054|NCT03209661|Drug|E-cigarette|E-Cigarette containing 5.4% nicotine will be administered to determine the effects on vascular function.
15957055|NCT03209661|Drug|Nicotine 0%|E-Cigarette containing 0% nicotine will be administered to determine the effects on vascular function.
15957056|NCT03209661|Drug|Menthol Inhalant Product|Menthol inhaler will be administered to determine the effects on vascular function.
15957057|NCT03209648|Drug|Debio 1450|Debio 1450, 40 mg capsule.
15957058|NCT03209648|Drug|Itraconazole|Itraconazole, 20 mL of 10 mg/mL solution.
15957059|NCT03209635|Dietary Supplement|Placebo|4 capsules (300 mg/capsule) containing 52% crystalline cellulose and 46% lactose in identical-looking with test product
15957060|NCT03209635|Dietary Supplement|Probiotic|4 capsules (300 mg/capsule) containing each capsule 1.0 x 10^10 colony-forming units (cfu) of Weissella cibaria JW15, twice a day
15957061|NCT03209622|Procedure|Nicotine replacement therapy delivred in cardiology intensive care unit versus Nicotine replacement therapy delivered after hospital discharge|when patient is admitted in intensive care of cardiology for acute coronary syndrome he is randomized to Arm A or Arm B
15957062|NCT03209622|Drug|Nicotine patch|Arm A
15957063|NCT03209622|Other|the external consultation|without patch
15957064|NCT03209609|Device|VEST|External support for vein grafts, cobalt chrome braid
15957065|NCT03209609|Procedure|Coronary artery bypass vein grafts|Bypass coronary arteries with autologous saphenous vein grafts
15957066|NCT03209596|Dietary Supplement|Orange juice (1L/d)|The players (n=17) drank 1 liter per day of orange juice. We do not interfere on the volunteers' usual diet during the study, and they did not ingest any commercial nutritional supplements in this period. During the intervention, the volunteers were engaged in a common training routine specified by the coach's team.
15957067|NCT03209596|Dietary Supplement|Control drink (1L/d)|The players (n=13) drank 1 liter per day of the control drink during a 60-day period. We do not interfere on the volunteers' usual diet during the study, and they did not ingest any commercial nutritional supplements in this period. During the intervention, the volunteers were engaged in a common training routine specified by the coach's team.
15957068|NCT03209583|Device|Medtronic|Pacing is done by the implanted device after seeing how the electrical system is functioning giving energy when needed to maintain a stable state or rhythm
15957069|NCT03209570|Other|Care planning using TENA Identifi sensor wear data|All individuals in this arm will receive TENA Identifi sensor wear and will have data available for care planning.
15957070|NCT03209570|Other|Care planning without using TENA Identifi sensor wear data|All individuals in this arm will receive TENA Identifi sensor wear but the sensor wear data will not be used for care planning.
15957071|NCT03209557|Other|SmartWatch SmokeBeat Application|The SmokeBeat app is a digital health app that allows for the user to monitor their smoking behavior in real time, set smoking cessation goals, and allows investigators, doctors and others using the app with participants to send messages directly related to smoking behavior. The SmokeBeat app, developed by Somatix Inc., will collects time-stamped on hand movements associated with smoking behavior. Participants will receive notifications on their phone and smartwatch when a smoking bout has been detected. In addition this app will deliver daily text messages aimed at improving quit rates among participants. We will be able to create the types of messaging we want to send and to modify when these messages will be sent to all participants. http://somatixinc.com/smokebeat/
15957072|NCT03209544|Behavioral|Online self-help intervention|The intervention was originally developed by van Spijker, van Straten, and Kerkhof (2010). For this study, it was adapted to the Flemish context and called Think Life. Think Life is mainly based Cognitive Behaviour Therapy (CBT). Additionally, it encompasses elements from Dialectical Behaviour Therapy (DBT), Problem Solving Therapy (PST), and Mindfulness Based Cognitive Therapy (MBCT). It encompasses six modules and every module starts with a psycho-educational section followed by a weekly assignment, core exercises and optional exercises. The participant weekly receives access to a new module. A more detailed description of the intervention is described elsewhere (Kerkhof, van Spijker, & Mokkenstorm, 2013; van Spijker et al., 2010; van Spijker, van Straten, et al., 2014).
15957073|NCT03209531|Behavioral|Operant Conditioning|Active encouragement and feedback to increase motor evoked response when stimulated.
15957074|NCT03209531|Behavioral|Control|Absence of active encouragement and feedback to increase motor evoked response when stimulated.
15957075|NCT03209531|Device|Single Pulse Transcranial Magnetic Stimulation|Transcranial magnetic stimulation to elicit a motor evoked response from the quadriceps muscles.
15957076|NCT03209518|Drug|Leuprorelin acetate|Leuplin PRO for Injection Kit 22.5 mg
15957077|NCT03209505|Device|Acuvue Oasys|FDA approved contact lens, fit for daily wear
15957078|NCT03209505|Device|Air Optix Night & Day Aqua|FDA approved contact lens, fit for daily wear
15957079|NCT03209492|Drug|Leuprorelin acetate|Leuplin PRO for Injection Kit 22.5 mg
15957080|NCT03209479|Drug|Glatiramer acetate|Copaxone subcutaneous injection syringe
15957081|NCT03209466|Drug|Chlorhexidine gluconate at 0.125%|Application every 24 hours, six weeks Intervention: Procedure: chlorhexidine gluconate
15957082|NCT03209466|Drug|Placebo Comparator with physiological saline sterile solution|Standard management and physiological saline sterile solution with application every 24 hours, six weeks Intervention.
15957252|NCT03208088|Device|etafilcon A Investigational Toric Multifocal Contact Lens|Control Lens
15957085|NCT03209440|Behavioral|Usual care|Palliative care nurses usually see patients each clinic visit to assess vital signs, function, symptoms, and to provide patient and family education. They document findings and interventions in the electronic health record (EHR). Whereas usual care for palliative care chaplaincy in the outpatient setting varies by site, chaplaincy care for usual care patients in this study will follow the usual practice for inpatient palliative care chaplaincy, which is to visit all new referrals to the clinic and assess their spiritual and religious needs. This assessment is then memorialized in a spiritual treatment plan documented in the EHR.
15957086|NCT03209440|Behavioral|Dignity Therapy - Chaplain Led|The chaplain-led DT intervention involves three sessions, each of which follows a set process. The standardize approach to the delivery of the intervention facilitates a personal process of reflection and recognition that allows the patient to make meaning of their experience.
15957087|NCT03209427|Drug|Morphine 100 μg|Intrathecal injection of morphine100 μg
15957088|NCT03209427|Drug|Morphine 200 μg|Intrathecal injection of morphine 200 μg
15957089|NCT03209401|Drug|Niraparib|an oral PARP inhibitor
15957090|NCT03209401|Drug|Carboplatin|a platinum-based injection
15957091|NCT03209362|Combination Product|SI-613|SI-613 will be repeated intra-articularly administered.
15957092|NCT03209362|Combination Product|Placebo|Placebo will be repeated intra-articularly administered.
15957093|NCT03209349|Procedure|Water Exchange Sigmoidoscopy|See arm description.
15957094|NCT03209349|Procedure|Air Insufflation Sigmoidoscopy|See arm description.
15957095|NCT03209336|Radiation|Intraoperative radiotherapy by Intrabeam（Zeiss Meditech，Jena，Germany）|We confirmed that if the patients had the distant metastasis before IORT. The median radiation dose was 5.00 Gy (range: 5.00-10.00Gy), the average dose was 6.00 Gy. The median radiation time was 0:33:24 (range: 0:21:45-1:06:23), which was the same with the patients'. All patients' surface dose ranged from 15.00 to 28.50 Gy.
15957096|NCT03209323|Device|electroencephalography (EEG)|Four EEG channels were recorded using electrode positions as defined in the International 10-20 System with Ag/AgCl2 cup electrodes (Spes Medica) attached to the scalp with EC2 Electrode Cream (Grass Technologies). The impedance was set below 1 k, and the electrodes were attached to module S/5 E-EEG of the anaesthetic monitor S/5 (GE Healthcare).
15957097|NCT03209323|Device|bispectral index (BIS)|The BIS score was derived from a sensor (Aspect Medical Systems) positioned diagonally on the patients' foreheads according to producer's instructions.
15957098|NCT03209323|Device|response and state entropy (RE and SE)|The respone and state entropy (RE and SE) score was derived from a sensor (Aspect Medical Systems) positioned diagonally on the patients' foreheads according to producer's instructions.
15957099|NCT03209323|Device|middle latency auditory evoked potentials (MLAEP)|value of A-line Auto Regressive Index (AAI) derived from middle latency auditory evoked potentials (MLAEP) (A-line Monitor, Danmeter A/S, Odense, Denmark) was observed which measures the central nervous system responsiveness to a specific auditory stimulus
15957100|NCT03209297|Other|TMD treatment: physiotherapy and/or occlusal splints|The patient will receive the most appropriate TMD treatment, based on current literature.
15957101|NCT03209284|Procedure|transcrestal sinus floor elevation|augmentation procedure with xenograft
15957102|NCT03209271|Drug|Ringer's Acetate (warm)|Body temperature fluid
15957103|NCT03209271|Drug|Ringer's Acetate (cold)|Room temperature fluid
15957104|NCT03209258|Other|Care bundle of active management|"Intensive BP lowering to systolic target of <140mmHg;
~Glucose control target 6.1-7.8 mmol/l for non-diabetic; 7.8-10.0 mmol/l for diabetic patients;
~Treatment of pyrexia to a target body temperature ≤37.5 ℃;
~Reversal of anticoagulation to target INR <1.5 involving use of vitamin K and prothrombin complex concentrate (PCC) or alternatively, fresh frozen plasma (FFP).
~As the trial is an assessment of care bundle of physiological management, there is some flexibility in the use of particular BP lowering agents and antipyretic agents to achieve targets."
15957105|NCT03209258|Other|Usual care|Usual care decisions about the location of care delivery, investigations, monitoring, and all treatments will be made by the treating clinical team.
15957106|NCT03209245|Biological|Purethal Mites|perennial allergren specific immunotherapy during 24 months
15957107|NCT03209245|Other|placebo injection|perrenial injection wich were administered in same protocol as Purethal
15957108|NCT03209245|Diagnostic Test|monitoring of allergen specific IgE|measurement the serum specific IgE at the start and at the end of trial
15957109|NCT03209245|Diagnostic Test|monitoring of allergen specific IgG4|measurement the serum specific IgG4 at the start and at the end of trial
15957110|NCT03209232|Drug|Infliximab|Accelerated induction of infliximab in moderate to severe ambulatory prdiatric UC patients
15957111|NCT03209219|Drug|Interferon Alfa-2A|3×10^6 IU， subcutaneous or intramuscular injection, qd for × 4 weeks, and qod thereafter
15957112|NCT03209219|Drug|Cyclosporine Pill|100mg， oral, bid
15957113|NCT03209206|Drug|Docetaxel|Intravesical Instillation of Docetaxel (Docetaxel 75 mg diluted in 100 cc of normal saline) after operation of Upper urinary tract urothelial carcinoma (With in 48 hrs)
15957114|NCT03209206|Drug|Placebo Normal saline|Intravesical Instillation of Normal saline (100 cc of normal saline) after operation of Upper urinary tract urothelial carcinoma (With in 48 hrs)
15957115|NCT03209193|Drug|Sevoflurane|Sevoflurane use as main anesthetic drug during the surgery
15957116|NCT03209193|Drug|Desflurane|Desflurane use as main anesthetic drug during the surgery
15957117|NCT03209180|Drug|CarVeDilol-SR (Slow Release)|patients will receive slow-release carvedilol (SR) once daily
15957118|NCT03209180|Drug|Carvedilol IR (Immediate Release)|patients will receive immediate release carvedilol (IR) twice daily
15957119|NCT03209167|Behavioral|Questionnaire|Two study-specific questionnaires
15957120|NCT03209154|Diagnostic Test|Therapeutic drug monitoring|Therapeutic drug monitoring will be performed.
15957121|NCT03209154|Device|Home blood pressure monitoring|Patients will perform home blood pressure monitoring at home.
15957122|NCT03209141|Diagnostic Test|Diastolic function evaluation|Diastolic function assessed by impedance cardiography (test to be validated) is compared with the assessment by echocardiography (clinical standard)
15957123|NCT03209128|Radiation|Irradiation prophyllactique cérébrale|Irradiation prophyllactique cérébrale
15957253|NCT03208075|Other|normal diet|Diet containing 1500mg of phosphorus
15957254|NCT03208075|Other|low-phosphorus diet|Diet containing 500mg of phosphorus
15957124|NCT03209115|Drug|combination of calcium hydroxide and chlorhexidine|placement of calcium hydroxide and chlorhexidine as intracanal medicament after removal of old filling and mechanical preparation of root canal
15957125|NCT03209115|Drug|Calcium Hydroxide|placement of calcium hydroxide as intracanal medicament after removal of old filling and mechanical preparation of root canal
15957126|NCT03209102|Other|Clinical assessment|"Self-assessments based on questionnaires : Strengths and Difficulties Questionnaire - Development and Well-Being Assessment (SDQ-DAWBA) ; Pubertal Development Scale ; Life Events Questionnaire ; Childhood Trauma Questionnaire ; Abbreviated - Diagnostic Instrument for Borderline (Ab-DIB) ; Beck Depression Inventory ; Socio-demographic questionnaire)
~and clinical evaluation by a psychiatrist : Mini-International Neuropsychiatric Interview (MINI); Global Assessment of Functioning"
15957127|NCT03209102|Behavioral|Stress elicitation experiment|"The stress elicitation experiment is based on a time-constrained mental arithmetic test in the presence of an observer. The task usually lasts about 30 minutes.
~During the task, the investigators will monitor: neuro-vegetative parameters (skin conductance, temperature, respiratory and cardiac frequencies, and VNA) ; biological parameters : salivary Cortisol and Amylase before test (baseline), 15 min and 30 min after testing (respectively corresponding to Reactivity and Recovery) ; micro-behavioral cues extracted from 2D video and 3D sensors (Microsoft Kinect)."
15957128|NCT03209102|Other|Structural and Functional MRI|"Structural and Functional Magnetic Resonance Imaging (MRI). The functional acquisition will last 20 minutes and the structural acquisition 18 minutes. All MR image acquisition methodologies are already functioning on the 3 Tesla Prisma machine within the ICM(Brain and Spine Institute), Salpetriere. The fMRI session will provide three types of data: (1) task-related activity to probe the striato-limbic and prefrontal regions, (2) resting state connectivity to examine the integrity of canonical networks, and (3) MR structural images to measure regional volumes of key functional nodes.
~For the task-related fMRI study, the investigators will use the monetary incentive delay task that reliably elicit an activation in known functional networks underlying reward anticipation/outcome."
15957129|NCT03209102|Biological|salivary collections of amylase and cortisol|Collection of saliva samples of cortisol and amylase repeated three times
15957130|NCT03209076|Procedure|Robotic|Robotic low anterior resection
15957131|NCT03209076|Procedure|Laparoscopic|Laparoscopic low anterior resection
15957132|NCT03209063|Diagnostic Test|polymerase chain reaction|diagnostic test as Polymerase chain reaction for detection of Prothrombin gene and methylenetetrahydrofolate reductase gene polymorphisms
15957133|NCT03209050|Device|Central Venous Access Placement|Device inserted into the femoral vein to insert a central venous access catheter
15957134|NCT03209037|Drug|Peginterferon Alfa-2a|patients untreated in immune-active phase were given subcutaneous injection of Peginterferon Alfa-2a with starting dose of 180 mg/weekly in experiment group.
15957135|NCT03209024|Other|Handwritten logbook recording of home blood pressure readings|Participants use a handwritten logbook to record the details of their home blood pressure measurements, including systolic blood pressure, diastolic blood pressure, date, and time.
15957136|NCT03209024|Device|Smartphone assisted wireless recording of home blood pressure readings|Participants use a smartphone app and Bluetooth® technology to wirelessly record the details of their home blood pressure measurements, including systolic blood pressure, diastolic blood pressure, date, and time.
15957137|NCT03209011|Drug|Peginterferon Alfa-2a|patients untreated in immune-active phase were given subcutaneous injection of Peginterferon Alfa-2a with starting dose of 180 mg/weekly in experiment group.
15957138|NCT03208998|Drug|Peginterferon Alfa-2a|patients untreated in immune-active phase were given subcutaneous injection of Peginterferon Alfa-2a with starting dose of 180 mg/weekly in experiment group.
15957139|NCT03208985|Drug|Use Phase (Ulipristal Acetate, 30 mg)|"All subjects enrolled in the use phase of this open-label study will be given the opportunity to purchase and take 30 mg of ulipristal acetate.
~Subjects are to use the investigational product based on their understanding of the directions on the outer packaging including Drug Facts Label and inside the product packaging (in the Consumer Information Leaflet)."
15957140|NCT03208972|Drug|low dose hCG|
15957141|NCT03208972|Drug|hp-FSH|
15957142|NCT03208972|Drug|Corifollitropin Alfa|"Corifollitropin Alfa (Elonva) dosage depending on weight, once administered first day of ovarian stimulation for all subjects, and on day 7 they proceed with the treatment of the allocated group.
~<60 kg: Elonva 100 MCG > 60 kg: Elonva 150 MCG"
15957143|NCT03208959|Drug|HTI-1090|IDO/TDO inhibitor
15957144|NCT03208946|Other|High-CML diet|Participants will be randomly assigned to either a high-CML or to a low-CML diet for 5 days, and they will receive the 5 corresponding meals (breakfast, lunch, snacks and dinner) during the 5 days of the intervention. These preparations will be elaborated by a catering company with indications and supervision by the research group. The intervention will be based on an isocaloric diet with a distribution of 55 to 63% carbohydrates, 12 to 15% protein, 25 to 30% lipids and less than 10% saturated fat and it macro and micronutrients will be similar in both diets. The only difference will be the CML content.
15957145|NCT03208946|Other|Low-CML diet|Participants will be randomly assigned to either a high-CML or to a low-CML diet for 5 days, and they will receive the 5 corresponding meals (breakfast, lunch, snacks and dinner) during the 5 days of the intervention. These preparations will be elaborated by a catering company with indications and supervision by the research group. The intervention will be based on an isocaloric diet with a distribution of 55 to 63% carbohydrates, 12 to 15% protein, 25 to 30% lipids and less than 10% saturated fat and it macro and micronutrients will be similar in both diets. The only difference will be the CML content.
15957146|NCT03208933|Drug|Pirfenidone|Pirfenidone 2403 mg/d capsules orally will be given in divided doses (TID) after titration period of 14 days.
15957147|NCT03208920|Dietary Supplement|Pro-Omega|Pro-Omega (Nordic Naturals, Watsonville, CA, USA). Each Pro-Omega capsule is 550 mg. Must take 4400 mg/day x 6 months.
15957148|NCT03208920|Other|ProOmega Placebo|Placebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA). Each soybean capsule is 550 mg. Must take 4400 mg/day x 6 months.
15957153|NCT03208894|Drug|Furosemide Injection|efficacy of salbutamol and furosemide in TTN
15957154|NCT03208881|Dietary Supplement|Dietary Supplement: Intensive dietary intervention|Participants receive a hypo-caloric formula diet containing 800 to 1,000 kcal/day. The formula diet consists of ready-to-use meal bars and powders to mix with water to make shakes, soups, or porridge. The weight loss programme consists of an 8-week period with full meal replacement by a standard liquid energy intake protocol. To facilitate compliance with the programme, participants will be scheduled for weekly facility-based group sessions with 6-8 participants led by a dietician. The recommendations for daily nutrient intake will be met.
15957155|NCT03208868|Dietary Supplement|Leucine enriched essential amino acid (EEA/LEU)|Patient with cirrhosis will be randomized to either take a Leucine enriched essential amino acid or a balanced amino acid supplement.
15957156|NCT03208868|Dietary Supplement|Balanced amino acid supplement (BAA)|Patient with cirrhosis will be randomized to either take a Leucine enriched essential amino acid or a balanced amino acid supplement.
15957157|NCT03208855|Behavioral|Cognitive Behavioral Therapy for Insomnia (CBT-I)|8 week 1-hour sessions of group CBT-I with each group including 3-4 men.
15957158|NCT03208842|Radiation|trans vaginal ultrasound|"trans vaginal ultrasound with partially filled bladder to nullify effect of anteversion of the uterus for assessment of
~---the site of the intrauterine gestational sac in relation to the endometrial cavity"
15957159|NCT03208829|Other|Rehabilitation exercises|Patients in group 1 will participate in a physical exercise protocol supervised by a physiotherapist. The sessions will focus on the rehabilitation of muscle strength and the exercises will be performed with increased external load.
15957160|NCT03208829|Other|Postoperative guidance|Group 2 will receive only guidelines regarding postoperative care.
15957161|NCT03208816|Behavioral|symptom management program for chemotherapy patients|Nurses will call study participants two times a week, to proactively assess and manage symptoms they might be experiencing during chemotherapy.
15957162|NCT03208790|Drug|Nigella sativa buccal tablets 10mg|thymoquinone will be extracted from Nigella Sativa and packed in buccal tablets of 10mg
15957163|NCT03208790|Drug|Nigella sativa buccal tablets 5mg|thymoquinone will be extracted from Nigella Sativa and packed in buccal tablets of 5mg
15957164|NCT03208790|Drug|Placebo buccal tablets|capsules with the same color and form as the active ones but without active ingredient will be given to the patients
15957165|NCT03208777|Genetic|taking blood samples|taking blood samples and measure telomeric abnormalities
15957166|NCT03208764|Drug|Nitric Oxide|Subjects will be treated with 91 thirty minute sessions of 160 ppm Nitric Oxide with at least 3 hours between each session.
15957167|NCT03208751|Behavioral|Exercise training|"Exercise intervention was divided into 3 phases:
~Phase 1: 6 weeks of moderate continuous training (MCT) 20 to 40 minutes at intensity of 60% of VO2peak, 3 times/week Phase 2: 6 weeks of moderate intensity interval training (MIIT) 30-40 min, intensity 60 to 80% of VO2peak, twice weekly plus at least once weekly MCT home based training Phase 3 (after performing new exercise testing to adapt training intensities): 12 weeks of MIIT 40 min once/week, intensity 60-80/85% of VO2peak, plus at least twice weekly home based MCT. From phase 2, supervised sessions included resistance training of at least 3 muscle groups, 3x15 repetitions at moderate intensity (Borg 12-14).
~Nutritional counseling is offered up to 4 times in 6 months on an individual basis."
15957168|NCT03208738|Behavioral|VetChange|VetChange is a self-management mobile application designed to to concurrently reduce both alcohol misuse and PTSD symptoms.
15957169|NCT03208738|Behavioral|web-based drinking assessment and feedback tool (AFT)|Program will administer a comprehensive assessment of drinking and consequences of drinking, and will provide normative feedback and highlight negative consequences of drinking.
15957170|NCT03208712|Drug|Atezolizumab|Atezolizumab 1200 mg IV once every 3 weeks
15957171|NCT03208712|Drug|Radium-223|Radium- 223 IV (55 kBq/kg) every 3 weeks for up to 6 doses
15957172|NCT03208686|Behavioral|Intervention Group|A single-arm intervention comprised of (a) 10 weekly discussion groups; (b) motivational text messages; (c) a remote sensing persuasive health technology - a cloud-based cellular glucometer connected to a dedicated web site to reduce A1c by 0.5% by improving diabetes self-management behaviors.
15957173|NCT03208673|Device|Optive® Fusion + Optive® Gel Drop|Optive® Fusion eyedrop will be used as needed up to four times a day but at least twice a day. The eyedrop will be used once in the evening; the gel drop being instilled any time during the last hour prior to sleep.
15957174|NCT03208660|Drug|Fycompa|Oral suspension
15957175|NCT03208647|Other|AA or not|to study their risk factors
15957176|NCT03208634|Device|Robotic intervention|One-month robotic intervention. Twelve sessions, three sessions a week, 40 minutes each. Twenty minutes of fully assisted reaching + 20 minutes of assisted Hand-to-Mouth
15957177|NCT03208608|Diagnostic Test|RBANS-H|The RBANS-H is a diagnostic cognitive test battery
15957178|NCT03208595|Diagnostic Test|Endometrial sampling of a Typical Embryo transfer catheter|no intervention no additional change from unit protocol
15957179|NCT03208582|Drug|Risedronate Sodium|Participants will be initially tested on the response to mechanical stimulation as a baseline and then tested again after 6 weeks treatment with Risedronate
15957180|NCT03208582|Dietary Supplement|Calcichew tablets|Participants will take calcichew tablets during the 6 week period of risedronate treatment
15957181|NCT03208556|Biological|iPD1 CD19 eCAR T cells|"iPD1 CD19 eCAR T cells are administrated in a 3-day split-dose regimen （d0, 30%; d1, 30%; d2, 40%）.
~CAR T cell dose escalation: 1×10^5 /kg，1×10^6 /kg，3×10^6 /kg，and 6×10^6 CAR T cells/kg"
15957182|NCT03208556|Drug|Fludarabine and cyclophosphamide|Fludarabine 25 mg/m2 d1-3; cyclophosphamide 250 mg/m2 d1-3. Lymphodepletion chemotherapy is completed 1 to 4 days before CAR T cell infusion
15957183|NCT03208543|Device|HECT-CL|To evaluate the effectiveness, safety and feasibility of thermotherapy with the low cost Hand-held Exothermic Crystallization Thermotherapy pad in the treatment of cutaneous leishmaniasis in Quetta, Balochistan, Pakistan.
15957184|NCT03208530|Behavioral|Brief motivational interview intervention|A brief (<7minutes) interview by an emergency department clinician to empower patients to formulate and communicate their goals for medical care with patients' outpatient clinicians.
15957185|NCT03208517|Other|Improving Wellbeing and Health for People with Dementia (WHELD) e-learning training programme|The e-learning WHELD intervention The optimised e-learning programme will consist of five 25-minute interactive online modules based on a recently completed RCT of an in person training programme (WHELD), combining the most effective elements of existing approaches to create a comprehensive but practical staff training intervention. Based on a factorial study and qualitative evaluation, WHELD combines: person-centred care, person-centred activities and interactions, and updated knowledge regarding optimal use of psychotropic medications.
15957186|NCT03208504|Device|Nexus™ Aortic Arch Stent graft|surgical implantation of Nexus™ Aortic Arch Stent graft
15957187|NCT03208491|Other|serious games use|This program has enabled several SGs to be developed that allow physical and cognitive workouts to be carried out with a therapist
15957188|NCT03208491|Other|usual care|usual care of patient
15957189|NCT03208478|Procedure|Adductor Canal perineural catheter placement|Patients will receive an Adductor Canal Block intervention for pain control following ACL reconstructive surgeries.
15957190|NCT03208478|Procedure|Femoral Nerve perineural catheter placement|Patients will have a Femoral perineural catheter placed for pain control following ACL reconstructive surgery.
15957191|NCT03208478|Device|Nimbus pump (Infutronix)|This is a FDA approved infusion device that is used in standard of care to store pain medication and to provide patients with continuous pain control medication at a set rate. This pump will be used for both the Adductor Canal and Femoral Nerve block participants.
15957192|NCT03208465|Drug|Empagliflozin|In empagliflozin group, patients will be prescribed empagliflozin 10mg/day.
15957193|NCT03208465|Drug|Sitagliptin|In sitagliptin group, patients will be prescribed sitagliptin 100mg/day.
15957194|NCT03208452|Drug|Magnesium Sulfate|Comparing the effect of continuous infusion magnesium sulfate and normal saline in the occurrence of emergence agitation
15957195|NCT03208452|Drug|Normal saline|Comparing the effect of continuous infusion magnesium sulfate and normal saline in the occurrence of emergence agitation
15957196|NCT03208439|Device|lower-limb cycling system|patients will receive 30-minute cycling exercise
15957197|NCT03208426|Drug|Esomeprazole (S14)|Nexium, esomeprazole 40mg bid, 14 days
15957198|NCT03208426|Drug|Esomeprazole (BQ10)|Nexium, esomeprazole, 40mg bid for 10 days
15957199|NCT03208426|Drug|Amoxicillin (ST14)|Day 1-7 amoxicillin (Brand name: Amoxicillin Capsule) 1000mg bid for 7 days
15957200|NCT03208426|Drug|Clarithromycin (ST14)|Klaricid-XL, clarithromycin, 500mg, bid, for 7 days, (day 8-14)
15957201|NCT03208426|Drug|Metronidazole (ST14)|Flagyl, metronidazole, 500mg bid, for 7 days (day 8-14)
15957202|NCT03208426|Drug|dibismuth trioxide 120mg (BQ10)|KCB F.C. TABLETS, dibismuth trioxide 120mg qid for 10 days
15957203|NCT03208426|Drug|Metronidazole (BQ10)|Flagyl, metronidazole 500mg tid for 10 days
15957204|NCT03208426|Drug|tetracycline (BQ10)|Tetracycline (Brand name: Tetracycline Capsule ) 500mg qid for 10 days
15957205|NCT03208413|Drug|Thalidomide|Thalidomide with a dosage of 25 mg at bedtime daily one week (days 1-7), then 50 mg at bedtime daily for one week (days 8-14), then 75 mg at bedtime daily for one week (days 15-21), then 100 mg at bedtime daily for 12 weeks (days 22-105), in the absence of unacceptable toxicity or severe deterioration.
15957206|NCT03208400|Behavioral|virtual reality exposure|one-session exposure conveyed via virtual reality technology
15957207|NCT03208387|Diagnostic Test|Diffusion tensor imaging (DTI)|DTI quantifies the degree to which water diffuses in different directions through a given brain region. The use of DTI as an in vivo index of the integrity of white matter has been applied to many disease states using several proprietary and open-source software programs (e.g. FSL 5.0). DTI tractography, employed via toolboxes such as Probtrackx within the FSL 5.0, allows the identification of white matter tracts connecting cortical and subcortical regions of interest. Furthermore, structural connectivity as measured with DTI does not duplicate functional connectivity as measure with rs-fcMRI, but rather provides complimentary perspectives.
15957208|NCT03208387|Diagnostic Test|Resting state functional connectivity MRI (rs-fcMRI)|rs-fcMRI is a relatively new neuroimaging technique that has been applied to studying multiple clinical populations including ADHD, schizophrenia, major depressive disorder, and other neurological disorders. The approach exploits measurement of changes in brain blood oxygenation (BOLD) as is employed in task based functional MRI (measuring changes in focal cortical vascular oxygenation when engaged in a defined task, e.g. motor movement). Neuroimaging data will be collected as soon as possible (can be the same day), for up to 6 weeks.
15957209|NCT03208387|Behavioral|Wechsler Intelligence Scale for Children - 5th edition (WISC-V)|Will gather IQ data and is the gold standard for IQ assessment for those between the ages of 6:0 and 16:11 years.
15957210|NCT03208387|Behavioral|California Verbal Learning Test (CVLT-C)|Validated measure of verbal learning and memory for those between the ages of 5:0 and 16:11.
15957211|NCT03208387|Behavioral|Beery Test of Visual Motor Integration 6th edition|Measure designed to assess visual-motor functioning of subjects between the ages of 2-99 years old by copying designs using paper and pencil.
15957212|NCT03208387|Behavioral|Grooved Pegboard|This is a standard assessment of fine motor functioning and dexterity by asking the subject to place metal pegs into holes on a board.
15957213|NCT03208387|Behavioral|PedsQL Multidimensional Fatigue Scale|Designed to measure fatigue in pediatric patients (ages 5-17 years) and is comprised of the General Fatigue Scale (6 items), Sleep/Rest Fatigue Scale (6 items) and Cognitive Fatigue Scale (6 items).
15957214|NCT03208387|Diagnostic Test|MRI|Images will be acquired on a 3.0 Tesla MRI scanner at each of the four study sites. At MSK, resting state fMRI data will be obtained using a 3T GE scanner with an 8-channel head coil (Discovery 750w DV25)
15957215|NCT03208374|Behavioral|Prior Exercise Behavior Questions - Harvard Health Professionals Exercise Questionnaire|Participants will be asked how often on average over the year prior to their most recent diagnosis they participated in walking or hiking; jogging; running; calisthenics, aerobics, rowing, Nordic track; bicycling; tennis, squash, racquetball; lap swimming; weightlifting; and other aerobic exercise (e.g. heavy outdoor work), as well as their usual walking pace and flights of stairs climbed daily over the past 12 months prior to diagnosis.
15957255|NCT03208075|Other|high-phosphorus diet|Diet containing 2300mg of phosphorus
15957216|NCT03208374|Behavioral|Current Exercise Behavior Questions: International Physical Activity Questionnaire Short Form (IPAQ SF)|The purpose of this questionnaire is to provide common instruments that can be used to obtain internationally comparable data on exercise exposure in adults aged 15 to 80 years old.
15957217|NCT03208361|Drug|Penicillin V|
15957218|NCT03208361|Drug|Amoxicillin|
15957219|NCT03208348|Other|Pilot Virtual Reality|Exposure to a virtual reality vignette with anxiety rating to support exposure therapy
15957220|NCT03208335|Drug|recombinant human endostatin|The cycles of rh-endostatin's treatment depends on the effect of reaction and tolerance.
15957221|NCT03208322|Other|Non-Interventional|Non-Interventional
15957222|NCT03208309|Drug|Diacerein|
15957223|NCT03208309|Drug|Placebo|
15957224|NCT03208296|Biological|ASN-002|ASN-002 has been designed for clinical applications, especially for intratumoral administration in the treatment of various cancers. This rAd vector delivers the gene of interest, in the case of ASN-002 the human IFNγ gene, into target cells. The rAd vector in ASN-002 is replication deficient and although it infects cells, it is not able to replicate in the tumor or in normal human cells. The infected cells are able to transcribe and translate the IFNγ DNA leading to a sustained local concentration of IFNγ in the tumor mass that is designed to avoid high levels of systemic IFNγ that may be lead to unacceptable toxicity.
15957225|NCT03208283|Diagnostic Test|Water method group|During the insertion phase of the initial 30 FS procedures, sterile water will be infused by a standard endoscopy water pump into the distal colon to allow passage of endoscope to ≥ 50cm above anal verge (including rectum, sigmoid colon and part of descending colon), or to the limit of patient tolerance of an unsedated procedure. Air insufflation will not be used during the insertion phase. Trainees will be allowed 10 minutes for the insertion phase. The unassisted portion of the examination would be terminated if reasonable progress is not being attained, excessive patient discomfort observed, or the supervising endoscopist believes that patient safety may be compromised. During the withdrawal phase, air insufflation will be used in standard fashion for examination of the colonic mucosa.
15957226|NCT03208283|Diagnostic Test|Air insufflation group|During the insertion phase of the initial 30 FS procedures, air insufflation will be used to allow passage of endoscope to at least 50cm above anal verge (including rectum, sigmoid colon and part of descending colon), or to the limit of patient tolerance of an unsedated procedure. Trainees will be allowed 10 minutes for the insertion phase. The unassisted portion of the examination would be terminated if reasonable progress is not being attained, excessive patient discomfort observed, or the supervising endoscopist believes that patient safety may be compromised. During the withdrawal phase, air insufflation will be used in standard fashion for examination of the colonic mucosa.
15957227|NCT03208270|Drug|Antithrombin supplementation|antithrombin concentrate will be supplemented to maintain a functional antithrombin level between 80%-120%
15957228|NCT03208270|Drug|No antithrombin supplementation|"supplementation of antithrombin will not be provided unless heparin resistance occurs"
15957229|NCT03208257|Drug|Esmolol|Esmolol hydrochloride infusion
15957230|NCT03208244|Drug|Clinically prescribed direct acting antiviral|HCV treatment for 12 weeks
15957231|NCT03208231|Biological|VRC01|40 mg/kg of VRC01 will be administered by subcutaneous injection.
15957232|NCT03208231|Drug|Combination Antiretroviral Therapy (cART)|All infants will receive non-study provided cART. Each infant's cART regimen will be selected by his or her primary care provider and supplied through non-study sources (i.e., ARVs will not be provided through the study).
15957233|NCT03208218|Drug|SYP-1512|Lenalidomide 25mg/tablet, PO, 1 tablet once daily for I&II D1(crossover)
15957234|NCT03208218|Drug|Revlimid cap|Lenalidomide 25mg/capsule, po, 1 capsule once daily for period I&II D1(crossover)
15957235|NCT03208205|Procedure|vitrectomy|Complete 23G PPV with scleral indentation was performed using Constellation system. Posterior vitreous detachment was induced very carefully by the cutter probe using aspiration. The peripheral vitreous was removed in all eyes with 360° of the vitreous base shaved under scleral indentation. After complete retinal attachment was achieved, endolaser photocoagulation was applied around the retinal break(s) as three to four rows of burns or/and cryopexy under HPFCL. Then a HPFCL/air/5000cst silicone oil exchange was performed. In one eye only HPFCL/air exchange was performed. Sclerotomies were sutured when needed with Vicryl 8.0 sutures.
15957236|NCT03208192|Procedure|liver transection during laparoscopic liver resection|liver transection during laparoscopic liver resection
15957237|NCT03208179|Drug|dihydroartemisinin-piperaquine|Women randomised to this intervention will receive 3 day treatment dose of dihydroartemisinin-piperaquine by body weight plus azithromycin placebo
15957238|NCT03208179|Drug|sulphadoxine-pyrimethamine|Women randomised to this intervention will receive stat dose of 3 tablets of 500 mg sulphadoxine and 25 mg of pyrimethamine each (total dose of 1,500mg sulphadoxine and 75mg pyrimethamine) on a single day of clinic visit
15957239|NCT03208179|Drug|dihydroartemisinin-piperaquine plus azithromycin|Women randomised to this intervention will receive 3 day treatment dose of dihydroartemisinin-piperaquine by body weight plus azithromycin (500mg)
15957240|NCT03208166|Device|Doctormate|Ischemic conditioning device
15957241|NCT03208166|Other|Usual Care|Standard medical care
15957242|NCT03208153|Procedure|Invasive|Coronary angiogram and revascularization if anatomically feasible
15957243|NCT03208153|Procedure|Conservative|Conservative
15957244|NCT03208127|Drug|Treatment with Direct Acting Antiviral tablet|HCV Treatment for 12 Weeks
15957245|NCT03208114|Other|Receiving written information on breast milk substitute|Receiving written information on breast milk substitute
15957246|NCT03208101|Biological|DTP-HepB-IPV-Hib vaccine|Hexavalent vaccine (DTP-HepB-IPV-Hib vaccine: Diphtheria-Tetanus-Pertussis-Hepatitis B-Inactivated Poliovirus-Haemophilus influenzae type b vaccine)
15957247|NCT03208101|Biological|DTP-HepB-Hib vaccine & IPV|Pentavalent vaccine (DTP-HepB-Hib vaccine: Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus influenzae type b vaccine)+ IPV(Inactivated poliovirus vaccine)
15957248|NCT03208088|Device|etafilcon A Investigational Toric Multifocal Contact Lens|Test Lens 1
15957249|NCT03208088|Device|etafilcon A Investigational Toric Multifocal Contact Lens|Test Lens 2
15957250|NCT03208088|Device|etafilcon A Investigational Toric Multifocal Contact Lens|Tes Lens 3
15957251|NCT03208088|Device|etafilcon A Investigational Toric Multifocal Contact Lens|Test Lens 4
15957256|NCT03208062|Other|collection of waste materials|osteoarthritis of the hip or knee and rehabilitated in the institute; primary and secondary tumors of the skeleton; prosthetic examination as a result of plant infection
15957257|NCT03208049|Behavioral|Sleep Restriction Therapy|Sleep Restriction Therapy will regulate time spent in bed based on information collected from sleep diaries during evaluation and treatment. Sleep Restriction therapy is designed to improve sleep quality by matching opportunity for sleep to the amount of average total sleep calculated from sleep diaries. Once the quality of sleep has improved, sleep quantity is gradually increased by slowly increasing sleep opportunity. Stimulus control will strengthen the bed/sleep association by eliminating non-sleep activities from the bedroom.
15957258|NCT03208049|Behavioral|Cognitive Therapy|Cognitive Therapy is designed to identify maladaptive beliefs about sleep, challenge their validity, and replace them with more adaptive thinking patterns. This therapy aims to reduce sleep-related worry, anxiety, and fear. The treatment phase of the study lasts six weeks. During treatment, you will meet with a study therapist for a total of six sessions: once per week for six consecutive weeks. Each session lasts approximately 60 minutes.
15957259|NCT03208036|Device|TDCS|1 mA of anodal stimulation will be applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training for 20 minutes
15957260|NCT03208036|Device|Sham Stimulation|Participants will receive 20 seconds of 1 mA anodal stimulation applied to the left dorsal lateral cortex (F3) concurrent with working memory focused cognitive training to mimic the effect of the active condition
15957261|NCT03208023|Procedure|RESIPI Management Strategy|a structured hemodynamic monitoring and treatment plan: RESIPI includes normalization of vascular resistance, correction of fluid responsiveness, and inotropy, and hemodynamic monitoring with the Starling SV (Cheetah Medical, Inc).
15957262|NCT03208023|Other|No intervention|No intervention
15957263|NCT03208010|Behavioral|Diabetes Prevention Intervention|"Educational sessions with emphasis on physical activity, healthy cultural diets, and strategies to promote positive behavioral changes.
~Specific goals set for weight loss and physical activities
~Fitbits provided for monitoring physical activity goals
~Weekly review of and feedback on effects of physical activity (Fitbits) & dietary changes (checklists)
~15 bi-weekly support group sessions + 3 booster sessions every 6 months thereafter"
15957264|NCT03208010|Other|Enhanced Usual Care|"Monitoring by existing personal physicians
~Feedback on lab results
~Referrals to physicians or clinics, if needed
~Diabetes prevention educational materials"
15957265|NCT03207997|Other|unenhanced MR sequences|2 additional unenhanced MR sequences
15957266|NCT03207984|Procedure|Root coverage surgery|Periodontal plastic surgery aiming the treatment of multiple gingival recessions in aesthetics areas with SCTG and MG
15957267|NCT03207971|Procedure|Root coverage treatment with subepithelial connective tissue graft|Periodontal plastic surgery aiming root coverage by palatal tissue graft removed from an area with predominance of lamina propria and predominance of submucosa.
15957269|NCT03207945|Drug|Alirocumab|Alirocumab (Sar236553/REG 727) is a fully humanized monoclonal antibody against the proprotein convertase subtilisin kexin type 9 (PCSK9) enzyme responsible for the degradation of the low-density lipoprotein receptor (LDLR), and is developed by Regeneron Pharmaceuticals/Sanofi.
15957270|NCT03207945|Other|Placebo|Placebo
15957271|NCT03207932|Procedure|Central vein catheterisation|ultrasound guided versus landmark central vein catheterisation
15957272|NCT03207919|Behavioral|Lullaby Project|Pregnant women will participate in 3 group sessions. They will write and record a lullaby, and then listen to each recorded lullaby and reflect on their experience.
15957273|NCT03207906|Drug|VBP-926|Topical VBP-926 solution
15957274|NCT03207893|Behavioral|GEM lifestyle modification & continuous glucose monitoring|Four treatment sessions of GEM lifestyle modification in 3 months and continuous glucose monitoring during the first 14 days of each of the 3 months.
15957275|NCT03207893|Other|Routine Care|Subject's current t2d treatment
15957276|NCT03207880|Device|Multi-level pregnancy test|Study participants will be instructed to perform a baseline MLPT immediately prior to administering the first dose of abortion medication and a second MLPT one week later to ascertain the follow-up hCG range. Any woman who obtains a stable or increasing hCG result, when comparing the baseline test result with the follow-up test result, will be instructed to contact safe2choose. Any woman who obtains a decrease in her hCG range, when comparing the baseline test result with the follow-up test result, will be informed that her abortion was a success and she is no longer pregnant.
15957277|NCT03207867|Drug|NIR178|NIR178, a new, non-xanthine based compound, is a potent oral adenosine A2a receptor against antagonist being developed by Novartis.
15957278|NCT03207867|Drug|PDR001|PDR001 is a human monoclonal antibody (MAb) administered day 1 of each cycle
15957279|NCT03207854|Procedure|Biospecimen Collection|Undergo collection of peripheral blood, bone marrow, and tissue
15957280|NCT03207854|Other|Laboratory Biomarker Analysis|Correlative studies
15957281|NCT03207854|Other|Questionnaire Administration|Ancillary studies
15957283|NCT03207828|Behavioral|Behavioral activation|The Brief Behavioral Activation Treatment for Depression (Lejuez, Hopko, Acierno, Daughters, & Pagoto, 2011; Lejuez, Hopko, LePage, Hopko, and McNeil; 2001) will be used. It aims are (1) to increase engagement with activities associated with pleasure or mastery experiences; (2) decrease engagement with activities that maintain or increase the risk of depression; (3) and remove the barriers that limit the access to gratification. The sessions of therapy are well structured and described in its manual. The protocol was originally designed to be applied individually. However, for the present research, it will be adjusted to be applied in group sessions (5-8 participants). Materials will be also adjusted to be use with Chilean population. Treatment core aspects will not be altered. The treatment will last 10 sessions over two months. Two psychologist trained in behavioral activation will lead the sessions.
15957314|NCT03207620|Diagnostic Test|airway corticosteroid sensitivity|each group is divided into two groups (patients who are already using inhaled corticosteroid ICS and patients who do not use ICS) and we compare between to groups in airway hypersensitivity.
15957315|NCT03207607|Other|Control snack|Isovolumetric (238.4g) gel snack prepared by real fruits (186.2kcal)
15957284|NCT03207828|Other|Usual care|Participants will be attended by a Medical Doctor that has a high level of expertise in fibromyalgia (rheumatologist or chronic pain specialist) at the Red Salud Christus, the most important private medical care network in Chile. In this clinic the protocol for the treatment of fibromyalgia includes administering pregabalin or gabapentin and pain killer (avoiding opioids). I addition, muscle relaxant such as cyclobenzaprine can be also administered to improve sleep quality. In a high proportion of cases (around 42%), antidepressant with analgesic properties, namely duloxetine, is prescribed. In addition, usual care includes derivation to psychiatrist if needed.
15957285|NCT03207815|Drug|Filgotinib|200 mg tablet(s) administered orally once daily
15957286|NCT03207815|Drug|Placebo to match filgotinib|Tablet(s) administered orally once daily
15957287|NCT03207815|Drug|Prednisone|Tablet(s) administered orally once daily
15957288|NCT03207802|Device|Discontinuation of using device|Subject will be instructed to discontinuation of use of device
15957289|NCT03207776|Other|Usual Care|Treatment of patients in the usual manner based on their diagnosis and resources available at that site.
15957290|NCT03207776|Other|COPD Clinical Pathway|A group of 4 Usual Care components that are applied consistently and completely amongst all patients who present with COPD acute exacerbation symptoms, plus access to navigator services.
15957291|NCT03207763|Device|Microneedle Formulation 1|"Microneedle patches will be made of solid conical structures made of water-soluble excipients that from the Food and Drug Administration's Generally Recognized as Safe (GRAS) list and/or on the FDA list of inactive ingredients in approved products. The total mass of excipients delivered by placebo microneedle patch will be <1.5 mg. The adhesive backing component is made from hypoallergenic material (commercial medical tapes designed to adhere to skin).
~Microneedle patches will be administered topically by manual application to the skin. The sites of microneedle patch application will be cleaned with an alcohol swab and allowed to dry before the microneedle patch is applied. The microneedle patches will be packaged and provided as single patches."
15957292|NCT03207763|Device|Microneedle Formulation 2|"Microneedle patches will be made of solid conical structures made of water-soluble excipients that from the Food and Drug Administration's Generally Recognized as Safe (GRAS) list and/or on the FDA list of inactive ingredients in approved products. The ratio of the excipients and excipients used will vary slightly from Formulation 1. The total mass of excipients delivered by placebo microneedle patch will be <1.5 mg. The adhesive backing component is made from hypoallergenic material (commercial medical tapes designed to adhere to skin).
~Microneedle patches will be administered topically by manual application to the skin. The sites of microneedle patch application will be cleaned with an alcohol swab and allowed to dry before the microneedle patch is applied. The microneedle patches will be packaged and provided as single patches."
15957293|NCT03207750|Biological|Rotarix|Two doses administered orally according to a 0, 2 month schedule as per the immunization schedule for HRV vaccine administration in the US.
15957294|NCT03207750|Biological|Pediarix|Three doses administered intramuscularly according to a 0, 2, 4 month schedule.
15957295|NCT03207750|Biological|Hiberix|Three doses administered intramuscularly according to a 0, 2, 4 month schedule.
15957296|NCT03207750|Biological|Prevenar 13|Three doses administered intramuscularly according to a 0, 2, 4 month schedule.
15957297|NCT03207737|Behavioral|MENTOR + Telehealth|Participants will live on campus for one week and complete the MENTOR program, which is a course about resilience and how nutrition, exercise and mindfulness help with resilience for individuals with a spinal cord injury. Different experts will cover the three main topics with lectures and application of knowledge through related activities. Participants will then begin a one-year telehealth program at home. The telehealth program will consist of readily available information focusing on nutrition, exercise and mindfulness for individuals with a spinal cord injury and a telehealth coach who will interact on the phone with the participants once every two weeks. This will continue for a total of 26 phone calls until the participant returns for 1-year follow-up testing.
15957298|NCT03207737|Behavioral|Telehealth Only|Participants will complete a one-year telehealth program at home. The telehealth program will consist of readily available information focusing on nutrition, exercise and mindfulness for individuals with a spinal cord injury and a telehealth coach who will interact on the phone with the participants once every two weeks. This will continue for a total of 26 phone calls until the participant returns for 1-year follow-up testing.
15957299|NCT03207724|Drug|Xilonix plus Onivyde and 5FU|Xilonix by IV
15957300|NCT03207711|Behavioral|Carbohydrate-restricted diet|Education for carbohydrate-restricted diet
15957301|NCT03207711|Behavioral|Mindfulness|Mindful eating app-use and instruction
15957302|NCT03207698|Procedure|Open flap debridement (OFD)|Open flap debridement (OFD) alone
15957303|NCT03207698|Procedure|OFD with Platelet rich fibrin (PRF)|Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement
15957304|NCT03207698|Procedure|OFD with Platelet rich fibrin (PRF)+1% Metformin (Drug) in gel form|Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1.2% Atorvastatin gel placement
15957305|NCT03207685|Device|Additional Seizure Monitoring|Embrace could offer an additional layer of seizure monitoring
15957307|NCT03207659|Procedure|Basketing in RIRS|Treament of renal stones by fragmentation of stone under direct vision through a flexible ureteroscope and then actively extracting them using a basket
15957308|NCT03207659|Procedure|Dusting in RIRS|Treament of renal stones by dusting the stone under direct vision through a scope and then leaving them to pass spontaneously
15957309|NCT03207646|Other|BrightHeart®|BrightHeart® has two components: smartphone mobile based application and a human coach. It is a combined approach of medication adherence, exercise, diet, sleep and stress reduction.
15957310|NCT03207633|Procedure|Repetitive trans-magnetic stimulation (rTMS) on DLPFC|Repetitive trans-magnetic stimulation (rTMS) on DLPFC
15957311|NCT03207633|Procedure|Repetitive trans-magnetic stimulation (rTMS) on OFC|Repetitive trans-magnetic stimulation (rTMS) on OFC
15957312|NCT03207633|Procedure|Sham repetitive trans-magnetic stimulation (rTMS)|Sham repetitive trans-magnetic stimulation (rTMS)
15957313|NCT03207620|Diagnostic Test|using serum periostin and eotaxin-2 level|"collect serum sample from each group and detection of serum periostin and eotaxin-2 are using Eliza kits.
~each group is divided into two groups (patients who are already using ICS and patients who do not use ICS) and we compare between to groups in airway hypersensitivity."
15957317|NCT03207607|Other|Whey protein snack|Isovolumetric (238.4g) gel snack with whey protein (201.8kcal)
15957318|NCT03207607|Other|Oat snack|Isovolumetric (238.4g) gel snack with oats and maltodextrin (275.8kcal)
15957319|NCT03207607|Other|Coconut oil snack|Isovolumetric (238.4g) gel snack with coconut oil (276.4kcal)
15957320|NCT03207607|Other|Snack skipping|no snack
15957321|NCT03207594|Other|Survey|Subjects will be asked to complete a survey asking questions about his/her current health, well-being and quality of life.
15957322|NCT03207594|Other|Saliva sample|Subjects will have saliva collected by a member of the study team using a cotton swab.
15957323|NCT03207594|Other|Smoking Status questions|Subjects will be asked to complete an assessment asking questions about his/her current smoking status
15957324|NCT03207581|Behavioral|Professional Coaching|Professional, individualized coaching
15957325|NCT03207568|Device|Thoracic Endovascular Aortic Repair (TEVAR)|thoracic endovascular repair (TEVAR) with a thoracic stent-graft
15957326|NCT03207555|Drug|Ibrutinib|420 mg by mouth once daily.
15957327|NCT03207542|Drug|Daratumumab|16 mg/kg by vein weekly for the first 2 cycles (8 weeks) of treatment, followed by every 2 weeks for 4 cycles (or 16 weeks) and then every 4 weeks until progression or up to 1 year of treatment whichever comes earlier.
15957328|NCT03207529|Drug|Alpelisib|Given PO
15957329|NCT03207529|Drug|Enzalutamide|Given PO
15957330|NCT03207516|Dietary Supplement|Sourdough --> Brewer's Yeast|Impact of bakery products with sourdough or brewer's yeast on digestive function
15957331|NCT03207516|Dietary Supplement|Brewer's Yeast --> Sourdough|Impact of bakery products with sourdough or brewer's yeast on digestive function
15957332|NCT03207503|Procedure|fMRI|Patients will undergo fMRI imaging to assess areas of the brain that are active during emotion regulation. No clinical benefit of MRI imaging is anticipated.
15957333|NCT03207490|Device|AMADEO|"Robot therapy: 1-Degrees-Of-Freedom (1DOFs) robot training for flexion and extention movements of the hand.
~Standard rehabilitation therapy includes speech, physical, occupational therapies and group activities"
15957334|NCT03207477|Diagnostic Test|Visual acuity measurement|visual acuity measurement by Baby Vision cards at 18 months corrected age, by Rossano Weiss test at 4 years of age and optometric tests of Parinaud and Snellen at 7 years of age
15957335|NCT03207464|Drug|[C-11]Methylreboxetine|8 individuals with Multiple Sclerosis and 4 healthy controls will undergo a [C-11]MRB PET scan and a MRI scan.
15957336|NCT03207451|Drug|Vorapaxar|Vorapaxar is the principle study drug and will be given to all subjects.
15957337|NCT03207451|Drug|Vorapaxar and Aspirin|Subjects in groups 3 will be on Aspirin when they begin Vorapaxar therapy.
15957338|NCT03207451|Drug|Vorapaxar and Clopidogrel|Subjects in groups 2 will be on Clopidogrel when they begin Vorapaxar therapy.
15957339|NCT03207451|Drug|Vorapaxar, Aspirin, and Clopidogrel|Subjects in groups 4 will be on both Aspirin and Clopidogrel when they begin Vorapaxar therapy.
15957340|NCT03207438|Drug|Quetiapine 50 MG Extended Release Oral Tablet|OD
15957341|NCT03207438|Drug|Quetiapine Fumarate XR 150-300 mg|Dose ranged from 150 to 300mg, XR preparation, OD
15957342|NCT03207438|Drug|Placebos|Placebo
15957343|NCT03207425|Drug|EDP 305|Each subject will receive a single dose of EDP 305 on Day 1.
15957344|NCT03207412|Biological|hAECs|human amniotic epithelial cells
15957345|NCT03207412|Procedure|Minimally invasive implantation|Minimally invasive implantation with ultrasound guidance
15957346|NCT03207399|Drug|Epclusa|Patients will be treated with this drug for 12 weeks post lung transplant.
15957347|NCT03207386|Behavioral|Youth VIP|Youth VIP involves youth in partnerships with adults to adapt evidence based sexual violence prevention strategies for the local community environment. Youth VIP includes a three day intensive youth summit for prevention training and ongoing youth-adult prevention working groups.
15957348|NCT03207373|Diagnostic Test|Stress test (ECG)|Every study participant undergoes a standard diagnostic stress ECG
15957349|NCT03207360|Behavioral|Pain Coping Skills|Participants will be trained in pain coping skills and meaning-centered psychotherapy. The intervention will consist of 4 weekly videoconference-delivered sessions that will last between 45 and 60 minutes.
15957350|NCT03207347|Drug|Niraparib|Patients will take 300 mg of niraparib orally once daily each day of a 28 day cycle.
15957351|NCT03207334|Drug|Midostaurin|"Induction Phase: 50 mg orally twice daily beginning on day 7 and ending 48 hours prior to beginning the consolidation phase
~Consolidation Phase: 50 mg orally twice daily beginning on Day 6 and ending 48 hours prior to either the start of the next cycle or beginning conditioning therapy for allogenic stem cell transplant."
15957352|NCT03207334|Drug|Cytarabine|"Induction Phase: 3 g/m2 (patients 18-65 years old) or 1 g/m2 (patients > 65 years old or those with co-morbidities precluding a higher dose) by vein over 3 hours every 12 hours on Days 1-6.
~Consolidation Phase: 3 g/m2 (patients 18-65 years old) or 1 g/m2 (patients > 65 years old or those with co-morbidities precluding a higher dose) by vein over 3 hours every 12 hours on Days 1, 3, and 5 of each cycle."
15957353|NCT03207321|Dietary Supplement|Upma|A balanced protein-calorie supplement - made from locally available corn-soya ingredients and called 'upma'.
15957354|NCT03207308|Dietary Supplement|Vitamin A supplementation|200,000 IU of preformed vitamin A
15957355|NCT03207295|Drug|Nesiritide|A standard dose of study drug was administered by a continuous infusion for ≥24 hours and ≤7 days after cardiac intensive care unit admission
15957356|NCT03207295|Drug|Normal saline|Normal saline(2ml/h) is administered by a continuous infusion for ≥24 hours and ≤7 admission days after cardiac intensive care unit in postoperative children
15957357|NCT03207269|Other|Dietary|Diet will be manipulated by providing different bedtime snacks within an otherwise isocaloric diet.
15957358|NCT03207256|Drug|TGR-1202|Oral Daily TGR-1202
15957359|NCT03207256|Drug|TGR-1202 + Ublituximab|Oral Daily TGR-1202 + Ublituximab IV Administration
15957360|NCT03207243|Drug|GSK3772847|GSK3772847 10 mg/kg will be administered as IV infusion once every 4 weeks to randomized subjects.
15957361|NCT03207243|Drug|Placebo|Placebo sterile normal saline will be administered as IV infusion once every 4 weeks to randomized subjects.
15957362|NCT03207243|Drug|Fluticasone propionate/salmeterol|FP/Sal 500/50 mcg will be administered via inhalation route twice daily to all subjects.
15957410|NCT03206905|Behavioral|Diet and Exercise|nutritional/exercise counseling
15957363|NCT03207243|Drug|Fluticasone propionate|FP 500, 250, 100 or 50 mcg will be administered via inhalation route twice daily to all subjects.
15957364|NCT03207230|Device|Cardea SOLO|Participants will be asked to wear everyday for 7 days after the Baseline visit. the monitor attaches to the skin with adhesive and records heart rate and heart rhythm.
15957365|NCT03207230|Device|ActiGraph wGT3X-BT|Participants will be asked to wear everyday for 2 weeks after the Baseline visit. The wearable tracks activity and the step count during the day.
15957366|NCT03207230|Device|Wavelet Wristband|Participants will be asked to wear everyday for 2 weeks after the Baseline visit. The wearable measures the activity and the heart rate as measured by PPG sensor.
15957367|NCT03207217|Other|Web-based training Product|A series of 4 modules to train providers to more effectively manage patients who screen positive for risk of suicide. The modules are: Risk Assessment, Safety Planning, Access to Lethal Means, and Willingness to accept referral.
15957368|NCT03207204|Procedure|35% Hydrogen peroxide bleaching|Application of 35% hydrogen peroxide on buccal face of anterior teeth (15-25). The application will be performed according to the manufacturer's instructions.
15957369|NCT03207204|Procedure|30% Carbamide peroxide bleaching|Protocol: Application of 35% Carbamide peroxide on buccal face of anterior teeth (15-25). The application will be performed according to the manufacturer's instructions.
15957370|NCT03207204|Procedure|Violet LED bleaching 1|Protocol: Application of the Violet LED on buccal face of anterior teeth (15-25) with a distance of 8mm between the light source and teeth surface. The application will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. The procedure will be performed 1 time a week.
15957371|NCT03207204|Procedure|Violet LED bleaching 2|Protocol: Application of the Violet LED on buccal face of anterior teeth (15-25) with a distance of 8mm between the light source and teeth surface. The application will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. The procedure will be performed 2 times a week.
15957372|NCT03207204|Procedure|Photochemical protocol 1|Protocol: Application of 35% hydrogen peroxide on buccal face of anterior teeth (15-25). The application will be performed according to the manufacturer's instructions and associated with the application of Violet LED with a distance of 8mm between the light source and teeth surface. The application of Violet LED will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. The procedure will be performed 1 time a week.
15957373|NCT03207204|Procedure|Photochemical protocol 2|Protocol: Application of 30% Carbamide peroxide on buccal face of anterior teeth (15-25). The application will be performed according to the manufacturer's instructions and associated with the application of Violet LED with a distance of 8mm between the light source and teeth surface. The application of Violet LED will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. The procedure will be performed 1 time a week.
15957374|NCT03207204|Procedure|Hybrid technique 1|Protocol: Application of the Violet LED on buccal face of anterior teeth (15-25) with a distance of 8mm between the light source and teeth surface. The application will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. In the last 10 illuminations of Violet LED it will be applied the 35% Hydrogen peroxide to act concomitantly with the light.
15957375|NCT03207204|Procedure|Hybrid technique 2|Protocol: Application of the Violet LED on buccal face of anterior teeth (15-25) with a distance of 8mm between the light source and teeth surface. The application will be performed for 60s, and then turned off for 30s. It will be repeated for 20x. In the last 10 illuminations of Violet LED it will be applied the 30% Carbamide peroxide to act concomitantly with the light.
15957376|NCT03207191|Drug|F16IL2|F16IL2 dose escalation with provisional doses of 10, 20 and 30 Mio IU on Day 1, 8, 15 and 22 of each cycle through a rate-controlled intravenous infusion of 3 hours
15957377|NCT03207191|Drug|BI 836858|BI 836858 dose escalation with provisional doses of 10, 20, 40, 80 and 160 mg on days 3, 10, 17 and 24 of each cycle through a rate-controlled intravenous infusion up to 5 hours
15957378|NCT03207178|Biological|Mixed CD19/CD20 CAR-T Transfer|Autologous CD19 CAR-T cells and CD20 CAR-T cells with average 1-5*10^6 cells/kg body weight,separately.
15957379|NCT03207165|Drug|Milrinone|Patients will be initiated on Milrinone at 0.125 mcg/kg/min [stage 1] and will be titrated according to a blinded protocol from stages 2 to 5 [0.250, 0.375, 0.5 and >0.5 ug/kg/min]. All orders to initiate and titrate the dose of the allocated inotrope will be written in the chart as follows: 'Study inotrope dose to be [increased/decreased/maintained] at stage [1-5]' so as to ensure that treating physicians remain blinded to the allocated drug.
15957380|NCT03207165|Drug|Dobutamine|Patients will be initiated on Dobutamine at 2.5 mcg/kg/min [stage 1] and will be titrated according to a blinded protocol from stages 2 to 5 [5.0, 7.5, 10 and >10 ug/kg/min]. All orders to initiate and titrate the dose of the allocated inotrope will be written in the chart as follows: 'Study inotrope dose to be [increased/decreased/maintained] at stage [1-5]' so as to ensure that treating physicians remain blinded to the allocated drug.
15957381|NCT03207152|Biological|Influenza A/California/04/09|Good Manufacturing Practices-certified Influenza A/California/04/09 3.5x10(4) TCID50 in 1 mL in DPBS delivered by intranasal drops
15957382|NCT03207139|Drug|Ga-68 PSMA ligand|"For PET/CT PSMA ligand scan, the subject will have catheter(s) placed for intravenous administration of [68Ga]PSMA ligand . Subjects will receive a single intravenous bolus of 2-5 mCi [68Ga]PSMA ligand and received PET/CT scan 60 minutes later. The data acquisition begin with non-contrast CT at 120kVp, automated mAs, and a pitch of 1.5, followed by PET acquisition from the mid-thigh to skull-base, 3 minutes each bed. After image acquisition, the subject will be observed for half an hour, and will be discharged if no adverse event happens.
~The estimated organ doses show that the kidneys and the urinary bladder wall were the organs with the highest dose. As presented, the effective doses for patients were 0.023 mSv/MBq ± 15% (maximum deviation), leading to an effective dose of 3.4 mSv for an injected activity of 150 MBq."
15957383|NCT03207126|Diagnostic Test|Ultrasound guided biopsy|For women needed a hysteroscopy guided biopsy as part of routine standard of care, women will now receive an ultrasound guided biopsy first
15957384|NCT03207113|Behavioral|Ned|Prostate cancer survivorship application.
15957406|NCT03206944|Drug|Tomato Fruit Extract|Group 2 (STE) included 32 patients receiving standardized tomato extract (STE) (ZAAX, Sequia, Poland) at a dose of 213 mg orally in the morning
15957407|NCT03206931|Drug|Selitrectinib (BAY2731954)|Selitrectinib is administered as capsules or liquid formulation.
15957408|NCT03206918|Drug|Zanubrutinib|Zanubrutinib 160 mg (two - 80 mg white opaque capsules) taken by mouth (PO) twice a day (BID)
15957385|NCT03207100|Combination Product|Analgesia-first minimal sedation|Remifentanil will be administered by IV infusion and maintained at a dose of 0.025 μg/kg/min in non-mechanically ventilated patients and a dose of 0.05 μg/kg/min in mechanically ventilated patients. BP will be measured after 10 min of continuous infusion.If systolic BP is still ≥ 140 mmHg, then dexmedetomidine will be applied using an infusion pump at a dose of 0.2 μg/kg/h. BP will be measured again after 15 min of continuous infusion of dexmedetomidine. If systolic BP is still ≥ 140 mmHg, the dose of dexmedetomidine can be increased 0.1 μg/kg/h to the maximum of 0.6 μg/kg/h.If the maximum dose of dexmedetomidine does not lower blood pressure, use routine blood pressure reduction programs in each center to reduce blood pressure to the target range. Mechanically ventilated patients will be given a rapid remifentanil (0.5 μg/kg) infusion to reduce procedure-related pain.
15957386|NCT03207100|Combination Product|Antihypertensive treatment|Routine antihypertensive treatment will be performed in accordance with the protocol of each respective research center. Urapidil, nicardipine, and labetalol will be used in this group. Urapidil will be used as follows: a slow IV injection of 10-15 mg and then IV pumping for maintenance at an initial rate of 2 mg/min, adjusted according to BP to a maximum of 9 mg/min. Nicardipine will be used as follows: IV pumping at 0.5μg/kg/min adjusted according to BP to a maximum of 6μg/kg/min. Labetalol will be used as follows: IV infusion for maintenance at 1-4 mg/min until the aim is reached.The mechanically ventilated patients in the control group will be administered a rapid physiological saline infusion as a controlled pretreatment.
15957387|NCT03207087|Device|WEB Aneurysm Embolization|Subjects will be screened for study eligibility after giving informed consent. The WEB embolization procedure will be performed in the catheterization room using standard angiographic techniques.
15957388|NCT03207074|Diagnostic Test|iKnife i.e. Rapid Evaporative Ionisation Mass Spectrometry|The endometrial tissue will be analysed by this new technology and compared to gold standard (histopathology)
15957389|NCT03207061|Diagnostic Test|3D Ultrasound|A 3D ultrasound will be performed for all patients presenting to the clinic for suspected endometrial cancer (in addition to routine standard of care)
15957390|NCT03207048|Device|Repetitive Transcranial Magnetic Stimulation|Daily left DLPFC, at 110% motor threshold, with a frequency of 10 Hz. Stimulation will be applied in 3-second trains with a 15-second inter-train interval, for 50 trains per session
15957391|NCT03207048|Device|Sham repetitive transcranial magnetic stimulation|Sham Transcranial Magnetic Stimulation
15957393|NCT03207022|Procedure|axillary brachial plexus block|ultrasound guided axillary brachial plexus block with 20 ml local anaesthetic lidocaine with epinephrine and clonidine
15957394|NCT03207009|Genetic|LentiGlobin BB305 Drug Product|LentiGlobin BB305 Drug Product is administered by IV infusion following myeloablative conditioning with busulfan.
15957395|NCT03206996|Behavioral|Exposure therapy|"The therapist, child and family collaborate to set short and long term goals, develop the exposure hierarchy and Subjective Units of Distress (SUD) scale and design their challenge activities (i.e., exposures). The exposure hierarchy lists activities in ascending order from minimal exposure/minimally difficult (e.g, toilet is not flushed and bathroom door is closed while child walks by) to maximum exposure/maximally difficult (e.g., toilet is flushed repeatedly while child is inside the stall with the door closed). Treatment begins with exposure to activities on the lower end of the hierarchy, with adjustments as indicated, to present stimuli that provide a just-right level of difficulty as indicated by the participant's SUD level and therapists clinical judgment. Participants communicate the level of difficulty using their individualized SUD scale. Additionally, the child and family complete home exercises with exposures."
15957396|NCT03206996|Behavioral|Psycho-education|Child and caregiver receive education and training will be provided to improve the participant's self-awareness of his/her behavioral and emotional response to auditory stimuli, his/her ability to self-report anxiety/emotional response levels, as well as his/her ability to identify useful arousal level modulation/coping strategies. During this phase, the child, caregiver and therapist will collaborate to identify the participant's Subjective Units of Distress Scale (SUD) from 0-10 with each level defined, particularly for what levels are tolerable or intolerable.
15957397|NCT03206996|Behavioral|Caregiver education/home program development|Parents will be provided with education on home programs to facilitate treatment gains. Home programs will be designed specifically for each participant. Parent education and home programs are provided either concurrently or after the exposure phase for the family to apply these methods to other settings. Home programs can continue as a maintenance program after treatment has ended. At the end of the treatment phase, the study team will conduct the following assessments for a third time: (1) the Sensory Profile, a clinical tool commonly used in OT to assess parent reports of sensory processing difficulties in children, (2) Parent Stress Index - 4 to evaluate stress related to parent-child interactions, and (3) the Modified Khalfa Hyper-acusis Questionnaire to assess the level of hyper-sensitivity to sound.
15957398|NCT03206983|Device|Cana's Ring|The device is used during cataract surgery to help dilate small pupils (under 5mm)
15957399|NCT03206970|Drug|zanubrutinib|Administered as specified in the treatment arm
15957400|NCT03206957|Diagnostic Test|Funduscopic examination and retinal photography|A standardized funduscopic examination and retinal photography will be performed by an ophthalmologist focusing on optic nerve.
15957401|NCT03206957|Diagnostic Test|Serum levels of endostatin and angiogenesis factors|Serum levels of endostatin, angiopoietin and vaso endothelial growth factor will be analyzed
15957402|NCT03206957|Diagnostic Test|Renal and low urinary tract Doppler ultrasound|"Measurements of each kidney will include maximum renal bipolar length in a sagittal plane, renal width and thickness in an axial plane perpendicular to each other at the level of renal hilum and cortical thickness. Intensity of corticomedullary differentiation will estimated.
~Doppler ultrasound examination will assess renal arterial resistivity indexes"
15957403|NCT03206957|Diagnostic Test|Urinalysis|Urinalysis assessments will include assessments of microalbuminuria and microalbuminuria to creatinuria ratio. A spot urine sample will be collected from first morning void.
15957404|NCT03206957|Diagnostic Test|Anthropometric measures and vitals signs|weight, height and blood pressure will be assessed
15957405|NCT03206944|Drug|acetylsalicylic acid|Group 1(ASA) included 33 patients who received acetylsalicylic acid at a dose of 75 mg in the morning
15957409|NCT03206905|Procedure|Endoscopic Sleeve Gastroplasty|endoscopic, rather than surgical approach, to perform sleeve gastroplasty
15957411|NCT03206892|Device|laparoscopic ovarian drilling|laparoscopic ovarian drilling for polycystic ovary syndrome in infertile women comparing LESS surgery to conventional multiport laparoscopy
15957412|NCT03206866|Diagnostic Test|serum regucalcin antibody|serum regucalcin antibody
15957413|NCT03206853|Procedure|Hybrid Operating Techniques|It is a cooperation of existing endovascular interventional techniques and microsurgical techniques. Different from traditional management, hybrid operating techniques make it possible for 2 existing techniques conducting simultaneously in a hybrid operating theater. It optimizes the traditional microsurgical techniques for complex intracranial aneurysms and avoids the transportation of patients and the risks of intervals between stages in traditional ones. It includes balloon-assisted parental arterial occlusion, one-stage aneurysm clipping/wrapping/isolation and embolization/diverter implantation, etc.
15957414|NCT03206840|Behavioral|"control, meditation, hypnosis."|"three instructions will be given to each participant: control, meditation, hypnosis. The order of meditation and hypnosis will be randomized amongst two groups to avoid order effects."
15957415|NCT03206827|Other|70% animal, 30% plant proteins in diet|Diet contains 70% of proteins from animal sources (beef, pork, chicken, dairy products, fish) and 30% from plant sources (bread and cereals).
15957416|NCT03206827|Other|50% animal, 50% plant proteins in diet|Diet contains 50% of proteins from animal sources (beef, pork, chicken, dairy products, fish) and 50% from plant sources (bread and cereals, legumes, nuts, seeds, soy products).
15957417|NCT03206827|Other|30% animal, 70% plant proteins in diet|Diet contains 30% of proteins from animal sources (beef, pork, chicken, dairy products, fish) and 70% from plant sources (bread and cereals, legumes, nuts, seeds, soy products).
15957418|NCT03206814|Other|Usual care|Antihypertensive therapy is adjusted every 3 months on the basis of office blood pressure values.
15957419|NCT03206814|Other|POST-strategy|Antihypertensive therapy is adjusted every 15 days on the basis of home blood pressure values.
15957420|NCT03206801|Procedure|Kidney transplant biopsy|Elevated urine CXCL10 will trigger a study biopsy in patients randomized to the intervention arm. Subclinical rejection will be treated per protocol.
15957421|NCT03206788|Drug|Losartan|25 mg or 50 mg (based on patient's weight) Losartan tablets taken by mouth daily in the morning for week 1 followed by twice daily (one in the morning and one in the evening) on Weeks 2-12.
15957422|NCT03206788|Drug|placebo|Placebo tablets, matching the Losartan intervention, taken by mouth daily in the morning for week 1 followed by twice daily (one in the morning and one in the evening) on Weeks 2-12.
15957423|NCT03206775|Behavioral|Cognitive Assessments (Phase 1)|"Participants will participate in up to 6 assessments in 4 domains of cognition: Processing Speed; Executive Attention; Learning and Memory; and Social Cognition.
~Assessments:
~Visual Sweeps
~Sustained Visual Attention
~Associative Learning--Visual
~Associative Learning--Auditory
~Emotion Motion
~Voice Choice"
15957424|NCT03206775|Behavioral|Cognitive Battery A (Phase 2)|"Participants will complete two visual assessments, one auditory assessment, and one social cognition assessment. Then the participant will complete self-report surveys.
~Assessments:
~On trails: Learning
~Line Length Discrimination
~Tap the Emotion
~Sound Sweeps
~BIS/BAS
~TEPS
~Feasibility survey"
15957425|NCT03206775|Behavioral|Cognitive Battery B (Phase 2)|"Participants will complete two visual assessments, one auditory assessment, and one social cognition assessment. Then the participant will complete the complete self-report surveys.
~Assessments:
~Visual Time Order Judgment
~Target Tracker
~Emotional Face
~Auditory Sound Discrimination
~BIS/BAS
~TEPS
~Feasiblity assessment"
15957426|NCT03206775|Behavioral|Cognitive Battery C (Phase 2)|"Participants will complete two visual assessments, one auditory assessment, and one social cognition assessment. Then the participant willcomplete self-report surveys.
~Assessments:
~Stroop 2AFC
~Visual Task Switcher
~Beep Seeker
~Voice Choice
~BIS/BAS
~TEPS
~Feasibility Survey"
15957427|NCT03206762|Device|Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm|Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm
15957428|NCT03206749|Drug|VX-150|Participants received VX-150 1500 milligram (mg) as first dose, followed by VX-150 750 mg dose every 12 hours (q12h) for 2 days.
15957429|NCT03206749|Drug|HB/APAP|Participants received HB 5 mg/APAP 325 mg every 6 hours (q6h) for 2 days.
15957430|NCT03206749|Drug|Placebo|Participants received placebo matched to VX-150 and HB/APAP for 2 days.
15957431|NCT03206736|Other|Loop DS surgery|these patients will receive a loop DS bariatric procedure
15957432|NCT03206723|Device|Bandage contact lens|"Bandage contact lenses (BCL) have the advantage of pain reduction, facilitating epithelial healing, and improved surface healing. They have been used in the ophthalmology community to treat post-operative eye pain due to the large corneal abrasion created during Excimer photorefractive keratectomy (PRK), laser in situ keratomileusis (LASIK), and radial keratotomy (RK) with good success.
~Bandage contact lenses have also been used in studies in Europe through ophthalmology clinics to treat traumatic corneal abrasions with excellent results. A British study from 1987, found that large diameter contact lenses can be fitted satisfactorily without the use of special equipment such as keratometry. Studies in rabbits have also been performed showing improved rates of healing when using bandage contact lenses. BCLs have been used to treat epithelial defects from various causes for up to 7 months at a time."
15957433|NCT03206723|Drug|Eyedrop|Fluoroquinolone eyedrops 4x/day
15957434|NCT03206723|Drug|Hydrocodone|Hydrocone 1-2 tabs 4x/day if needed
15957435|NCT03206710|Other|No current intervention|This is a follow-up of two randomized trials. No active intervention is being given in the follow-up
15957436|NCT03206697|Other|Mitochondrial DNA content and metabolic parameters|Analyze the correlation between the mitochondrial DNA content and metabolic parameters.
15957437|NCT03206684|Drug|PEG-rhG-CSF|PEG-rhG-CSF single-dose was administered subcutaneously 48h after chemotherapy，weight ≥ 45kg were given 6mg once per chemotherapy cycle, weight <45kg were given 3mg once per chemotherapy cycle.
15957438|NCT03206684|Drug|rhG-CSF|rhG-CSF was administered subcutaneously 48h after chemotherapy，weight≥45kg were given 300μg/d, weight<45kg were given 150μg/d,continuous injection for 3-5 days until the absolute neutrophils count≥2×10^9/L.
15957439|NCT03206671|Drug|Rituximab window|Rituximab window (375 mg/m²)
15957474|NCT03206463|Drug|2 mg Delta-9-THC|Subject will have 1/3 chance of receiving 2 mg THC administered through a vaporizer, over approximately 20 minutes, followed by approximately 45 minutes of neuropsychological and physiological testing.
15957440|NCT03206671|Drug|Additional doses of Rituximab|2 doses of Rituximab (375 mg/m²) before the start of the first chemotherapy cycle, 2 doses of Rituximab before the start of the second chemotherapy cycle, 1 dose of rituximab before the start of the third chemotherapy cycle, 1 dose of Rituximab before the start of the forth chemotherapy cycle
15957441|NCT03206671|Drug|Cyclophosphamide|see detailed protocol description
15957442|NCT03206671|Drug|Cytarabine|see detailed protocol description
15957443|NCT03206671|Drug|Dexamethasone|see detailed protocol description
15957444|NCT03206671|Drug|Doxorubicin hydrochloride|see detailed protocol description
15957445|NCT03206671|Drug|Vindesine Sulfate|see detailed protocol description
15957446|NCT03206671|Drug|Etoposide|see detailed protocol description
15957447|NCT03206671|Drug|Ifosfamide|see detailed protocol description
15957448|NCT03206671|Drug|Methotrexate|see detailed protocol description
15957449|NCT03206671|Drug|Prednisolone|see detailed protocol description
15957450|NCT03206671|Drug|Vincristine|see detailed protocol description
15957451|NCT03206658|Drug|Spironolactone 25 mg|A dose of 25 mg of spironolactone will be administered orally or through the nasogastric /nasoenteral tube to the patients every 24 hours, at 8-9 am.
15957452|NCT03206658|Drug|Placebo oral capsule|The contents of a placebo capsule will be administered orally or through the nasogastric / nasoenteral tube to the patients every 24 hours, at 8-9 am.
15957453|NCT03206645|Drug|PTC596|PTC596 will be given in combination with carboplatin and paclitaxel for up to 7 cycles depending on which cohort the patient is in.
15957454|NCT03206632|Drug|BI 690517|single dose
15957455|NCT03206632|Drug|Placebo|single dose
15957456|NCT03206619|Other|Social, Local and Mobile|Patients in a smoking cessation program will use a mobile application to receive messages and rate them from their smartphones. The messages patient will receive belong to one of the following five topics: general motivation, diet tips, physical exercise tips, personal performance, and the benefits of being a non-smoker. For each one of these topics, there will be a pool of 150 different messages with tailored information for the patient. Topics and messages were approved by a smoking cessation psychologist and a pulmonologist. The selection of the time the messages have to be sent, and the message topic is selected by an health recommender system algorithm based on the patients' user profile (demographic information, message rating information, and app interaction information).
15957457|NCT03206606|Device|SPIRO|Participants in the Experimental Group will be asked to use SPIRO mobile application during a period of 4 months.
15957458|NCT03206580|Other|Concentric training|Subjects will be submitted to 8 weeks (16 sessions) of a concentric training for knee flexors and knee extensors. This training will be performed in an isokinetic dynamometer at 70% of the subject's maximal voluntary isometric contraction.
15957459|NCT03206580|Other|Concentric-Eccentric training|Subjects will be submitted to 8 weeks (16 sessions) of a concentric-eccentric training for knee flexors and knee extensors. This training will be performed in an isokinetic dynamometer at 70% of the subject's maximal voluntary isometric contraction.
15957460|NCT03206567|Dietary Supplement|Nutrafol Supplement capsules|NUTRAFOL's Synergen Complex® is a patent-pending formulation of botanicals with potent anti-inflammatory, anti-stress adaptogenic, antioxidant and DHT-inhibiting properties - combined to synergistically combat the multiple underlying factors that compromise hair growth and health. Some patented ingredients include Sensoril Ashwagandha, BCM-95 BioCurcumin, USPlus Saw Palmetto, EVNolMax 20% Tocotrienol/Tocopherol complex, Bioperine (piperine), Cynatine HNS (solubilized keratin), and Capsimax (capsaicin), all of which are standardized and clinically tested. the Nutrafol supplement capsules are compared to the placebo capsules which contain no active ingredients. Four (4) capsules are taken by mouth once daily with a substantial meal.
15957461|NCT03206567|Other|Placebo capsules|The placebo capsules contain no active ingredients. Four (4) capsules are taken by mouth once daily with a substantial meal.
15957462|NCT03206554|Drug|Ropivacaine|Large volume local anaesthetic intraarticularly
15957463|NCT03206554|Other|Saline|sham injection
15957464|NCT03206528|Device|Vital Signs Monitoring System|The VSMS will be adhered to each enrolled patient for the entire hospitalization period.
15957465|NCT03206515|Device|18F Peel-Way Sheath|Patients undergoing Mini Percutaneous Nephrolithotomy with The 18F peel-way sheath
15957466|NCT03206515|Device|18F access sheath with a suction-evacuation function|Patients undergoing Mini Percutaneous Nephrolithotomy with The 18F access sheath with a suction-evacuation function
15957467|NCT03206502|Device|Embrace + Alert App|Participants will wear an Embrace smartwatch to collect data, and will provide survey/diary information on the occurrence of seizures. The device sends data to the Alert app, which issues either true detections or false alarms when it detects a possible convulsive seizure. Participants are asked to either cancel (in real time) or mark (at a later time) all false alarms using the Alert app.
15957468|NCT03206489|Device|noninvasive high-frequency ventilation (nHFOV)|noninvasive high-frequency ventilation (nHFOV) as a primary mode of ventilation in one of the preterm twins infants with respiratory distress syndrome
15957469|NCT03206489|Device|nasal continuous positive airway pressure (nCPAP)|nasal continuous positive airway pressure (nCPAP) as a primary mode of ventilation in another of the preterm twins infants with respiratory distress syndrome
15957470|NCT03206476|Behavioral|Nutritional intervention based on the SCT and the TM|Nutritional workshop based on the Cognitive Social Theory and the Transtheorical Model: twelve group sessions (one per week) lasting 40 minutes each, aimed at adolescents; With delivery of printed material to work at home (workbook); And two sessions (every month and a half) addressed to parents.
15957471|NCT03206476|Behavioral|Nutritional information|Three informative sessions of 25 minutes (one each month) on healthy eating habits and delivery of educational material to adolescents.
15957472|NCT03206463|Drug|4 mg Delta-9-THC|Subject will have 1/3 chance of receiving 4 mg THC administered through a vaporizer, over approximately 20 minutes, followed by approximately 45 minutes of neuropsychological and physiological testing.
15957473|NCT03206463|Drug|Placebo|Subject will have 1/3 chance of receiving the inhaled placebo condition administered through a vaporizer, over approximately 20 minutes, followed by approximately 45 minutes of neuropsychological and physiological testing. The placebo condition will include no active cannabinoids.
15957478|NCT03206437|Behavioral|Mindfulness-Based Stress Reduction|The MBSR course teaches mindfulness meditation skills. This 8-week course meets in person once a week for 2.5 hours. Participants are expected to complete practice assignments at home.
15957479|NCT03206437|Behavioral|Waitlist|This group will wait 8-16 weeks after their first testing visit and after their second study visit is completed they will be able to participate in an 8-week MBSR course.
15957480|NCT03206411|Diagnostic Test|Renal and liver function tests , ECG , Sex Hormones Profile|Renal Function tests as creatinine , Uric Acid , Blood urea. Liver Function tests as AST , ALT, ALP ECG (Electrocardiogram recording) SEX hormones as LH , FSH , and Testosterone
15957481|NCT03206398|Device|anti-gravity treadmill|anti-gravity treadmill for a total of 40 days in addition to physiotherapy
15957482|NCT03206385|Radiation|Radiation treatment|50 Gy will be delivered in the PTV 1 and 60 Gy in the PTV 2 simultaneously in 28 fractions (5 fractions a week) in no more than 40 days. Anytime, 95% of the prescribed dose will have to cover at least 90% of the PTV 1 and PTV 2.
15957483|NCT03206385|Radiation|CK Boost Pelvis|Two high CyberKnife dose sessions will deliver a pelvic boost of 6.5 Gy each to the initial GTV or eventually to the residual GTV in case of too close vicinity of the OAR
15957484|NCT03206372|Other|Case group|Questionnaire to be completed, blood sample and possibly echo-doppler
15957485|NCT03206372|Other|Control group|Questionnaire to be completed, blood sample and possibly echo-doppler
15957486|NCT03206346|Drug|Ingavirin|Ingavirin ( Imidazolyl ethanamide pentandioic acid) capsules, 60 mg once daily, regardless of meal, for 5 days.
15957487|NCT03206346|Drug|Placebo oral capsule|Placebo, capsules daily for 5 days.
15957488|NCT03206320|Drug|Lidocaine Topical|Comparison of lidocaine topical gel with lidocaine infiltration and with no local anesthesia in reducing needle insertion and injection pain
15957489|NCT03206294|Other|pharmacist assessment|St Joseph Hospital pharmacist assess every diabetic patient hospitalized in cardiology service in term of antidiabetic treatment during the hospitalization
15957490|NCT03206281|Diagnostic Test|Fetal wight estimation|We will estimate the fetal weight by sonographic and clinical estimation
15957491|NCT03206268|Device|SD-OCT and SLP using GDx variable corneal compensation|RNFL thickness measurements obtained using SD-OCT and SLP using GDx variable corneal compensation
15957492|NCT03206255|Procedure|3 doses of HPV 16/18 bivalent vaccine|Participants have received 60μg of HPV 16/18 bivalent vaccine according to the standard 3-dose schedule (0,1,6 months)
15957493|NCT03206255|Procedure|2 doses of HPV 16/18 bivalent vaccine|Participants have received 60μg of HPV 16/18 bivalent vaccine according to an alternative 2-dose schedule (0,6 months)
15957494|NCT03206242|Other|Physiotherapy|Interventions of physical therapy will be implemented after reconstructive surgery including edema control, scar management, pain management, respiration training, oral function training, neck and shoulder function training, donor site mobility training.
15957495|NCT03206229|Drug|PEG-rhG-CSF|PEG-rhG-CSF is going to be administered 2 mg/0.2 ml subcutaneously single dose in each study period as per the randomization schedule
15957496|NCT03206229|Drug|Neulasta (PEG-rhG-CSF)|PEG-rhG-CSF is going to be administered 2 mg/0.2 ml subcutaneously single dose in each study period as per the randomization schedule
15957497|NCT03206216|Diagnostic Test|Diode Laser fiber type Selective Stimulator (DLss)|A laser device to assess pain sensitivity to stimulation
15957498|NCT03206203|Drug|Atezolizumab|Given by vein
15957499|NCT03206203|Drug|Carboplatin|Given by vein
15957500|NCT03206203|Other|Laboratory Biomarker|Correlative study
15957501|NCT03206203|Other|Quality-of-Life Assessment|Ancillary studies
15957502|NCT03206190|Other|SPRS Score and clinical signs|Patients will clinically characterized by using the SPRS Score and the inventory V3
15957503|NCT03206190|Behavioral|Cognition Testing using CANTAB|Patients will be tested using the CANTAB
15957504|NCT03206190|Diagnostic Test|Lumbar Puncture and blood draw|Biomaterial will be collected (not obligate) to compare e.g. Nfl levels in serum and CSF
15957505|NCT03206190|Diagnostic Test|MRI|MRI will be used to reveal presymptomatic brain morphology changes (not obligate)
15957506|NCT03206190|Diagnostic Test|Electrophysiology|Electrophysiological tests will be used to characterize patients better.
15957507|NCT03206190|Diagnostic Test|Testing functional performance|By using the 3 minute walk, 5 stair-climb test, and 10m walking test we will try to identify and measure subclinical progression prior to disease onset
15957508|NCT03206190|Diagnostic Test|Non motor symptoms|By using a number of different tests we try to identify other non-motor symptoms which might manifest prior to disease onset.
15957509|NCT03206177|Drug|Galunisertib|Galunisertib 150mg po BID day 4-17.)
15957510|NCT03206177|Drug|Paclitaxel|Paclitaxel 175 mg/m2 over 3 hours
15957511|NCT03206177|Drug|Carboplatin|IV day 1 Carboplatin AUC 6* over 1 hour (or 5* if no prior radiation therapy)
15957512|NCT03206164|Other|Asynchronous, eLearning Intervention|20 CBOs with 3-member team (n= 30) will be recruited and placed into either the experimental or the comparison group.
15957513|NCT03206151|Drug|CMAB009|for injection only
15957514|NCT03206151|Drug|Irinotecan|for injection only
15957515|NCT03206151|Drug|Folinic acid|for injection only
15957516|NCT03206151|Drug|5-fluorouracil|for injection only
15957517|NCT03206138|Biological|GX-188E, GX-I7|Experimental: 1mg of GX-188E administered IM using EP device 3 times and 3mg of GX-I7 administered in cervix 4 times.
15957518|NCT03206138|Biological|GX-188E, Imiquimod|1mg of GX-188E administered IM using EP device 3 times and 12.5mg of Imiquimod application at cervix 8 times.
15957519|NCT03206112|Other|PAS25|We will record surface electromyography from the target abductor pollicis brevis muscle and adjacent first dorsal interosseous and abductor digiti minimi muscles.
15957520|NCT03206112|Other|PAS10|We will record surface electromyography from the target abductor pollicis brevis muscle and adjacent first dorsal interosseous and abductor digiti minimi muscles. TBS is a special form of
15957521|NCT03206112|Other|PAS25-cTBS150|We will record surface electromyography from the target abductor pollicis brevis muscle and adjacent first dorsal interosseous and abductor digiti minimi muscles.
15957522|NCT03206086|Drug|Eltrombopag|Daily dose - Non-Asian (greater than or equal to 12): 150 mg; Non-Asian (6-11): 75 mg; Non-Asian (4-5): 2.5 mg/kg; East Asian, South East Asian (greater than or equal to 12): 75 mg; East Asian, South East Asian (6-11): 37.5 mg; East Asian, South East Asian (4-5): 1.25 mg/kg
15957526|NCT03206060|Drug|Lu-177-DOTATATE|Lu-177-DOTATATE IV at weeks 1, 8, 16 and 24
15957527|NCT03206060|Drug|Ga-68-DOTATATE|Ga-68-DOTATATE PET/CT at weeks 15 and 31, every 24 weeks during 3 years follow up period
15957528|NCT03206060|Drug|F-18-FDG|F-18-FDG PET/CT at weeks 15 and 31, every 24 weeks during 3 years follow up period
15957529|NCT03206060|Drug|Amino Acid solution|AA solution will be administered 60 minutes prior to each Lu-177- DOTATATE infusion.
15957535|NCT03206034|Behavioral|Stylistic Memory Enhancement|
15957536|NCT03206021|Drug|5 Azacytidine|Dose escalation of carboplatin combined with 5'azacytidine
15957537|NCT03206008|Drug|Magnesium Sulfate|
15957538|NCT03206008|Drug|Normal saline|Placebo
15957539|NCT03205995|Biological|OMS721|Intravenous loading dose followed by daily subcutaneous injections
15957540|NCT03205982|Device|Wise app with medication adherence reminders|The Intervention group will receive the Wise app that delivers medication adherence reminders.
15957541|NCT03205982|Device|Wise app with fitness reminders|The control group will receive the Wise app with fitness reminders
15957542|NCT03205969|Device|Functional mobile game|Functional mobile game for chemotherapy side effect education
15957544|NCT03205930|Biological|Neo-MASCT|The end product of Neo - MASCT technology is DC and CTL cells.DC injection,in each treatment cycle day 8, axillary, inguinal lymph node with subcutaneous injection. CTL cells， in every treatment cycle 21-28 days.
15957545|NCT03205917|Biological|PGDM1400/Placebo (3mg/kg IV)|3/1 (6/2 if DLT)
15957546|NCT03205917|Biological|PGDM1400/Placebo (10mg/kg IV)|3/1 (6/2 if DLT)
15957547|NCT03205917|Biological|PGDM1400/Placebo (30mg/kg IV)|3/1 (6/2 if DLT)
15957548|NCT03205917|Biological|PGDM1400 + PGT121/Placebo (3mg/kg + 3mg/kg IV)|3/1 (6/2 if DLT)
15957549|NCT03205917|Biological|PGDM1400 + PGT121/Placebo (10mg/kg + 10mg/kg IV)|3/1 (6/2 if DLT);
15957550|NCT03205917|Biological|PGDM1400 + PGT121/Placebo (30mg/kg + 30mg/kg IV)|3/1 (6/2 if DLT)
15957551|NCT03205917|Biological|PGDM1400 + PGT121 + VRC07-523LS (20mg/kg + 20mg/kg + 20 mg/kg IV)|3 (max 9)
15957552|NCT03205917|Biological|PGDM1400 + PGT121 (MTD IV)|3 (max 9)
15957553|NCT03205904|Dietary Supplement|Diet|Nutrition booklet with guidelines on types of fats and glycemic index
15957554|NCT03205891|Drug|Brentuximab Vedotin|1.8 mg/kg by vein on Day 1 per cycle by vein over about 30 minutes on Day 1 of each cycle.
15957555|NCT03205891|Drug|TAK228|Starting Dose and Schedule of TAK228: 2 mg by mouth, 5 days on and 2 days off per week with repeated weekly cycles. The study doctor will tell participant how often to take the study drug.
15957556|NCT03205891|Device|Glucose Monitor|Participant monitors glucose (sugar) levels at home with a glucose monitor during the first 2 months participant is taking the study drug.
15957557|NCT03205878|Other|Telecoaching|"Patients in the intervention arm will receive a step counter and a cell phone with an app on which the amount of steps are daily sent to.
~Initial targets on steps per day will be discussed with the patient after an activity monitoring before the telecoaching procedure. Dependent whether the patient reaches his/her proposed goal each week, new goals are set."
15957558|NCT03205878|Device|CPAP|Patients will receive CPAP according to standard care
15957559|NCT03205852|Other|questionnaire|fulfillment of questionnaire
15957560|NCT03205839|Behavioral|Acceptance-based self-help intervention|"Surviving to Thriving: ACT self-help for living well with a visible difference in appearance.
~A self-help booklet, based upon Acceptance and Commitment Therapy (ACT). The booklet includes some ACT techniques and encourages participants to set themselves behavioural tasks, based upon their values. There is a suggested timetable for participants to navigate through the self-help during the four-week intervention period.
~In addition to the pdf booklet, there are accompanying audio exercises and a lived experience video."
15957561|NCT03205826|Other|Type of sedation used|All patients will undergo two subsequent Chartis measurements. The first measurement will be performed with the patient undergoing conscious sedation and the second measurement with the patient under general anesthesia.
15957562|NCT03205800|Other|Mini-screw|Placement of a mini-screw
15957563|NCT03205787|Dietary Supplement|Trifolium pratense|Red Clover extract standardized to isoflavone content.
15957564|NCT03205774|Behavioral|6 hours fasting and free oral intake of water|Ultrasound examination of the gastric antrum are performed in volunteers after prolonged fasting and 10 min after oral intake of water. Volunteer should be lying on his/her back, right lateral decubitus position and left lateral decubitus position with randomization of the order.
15957565|NCT03205761|Drug|Olaparib|see information in arm description
15957566|NCT03205735|Diagnostic Test|lymphocyte DPD dosage|lymphocyte DPD dosage in peripheral blood
15957567|NCT03205722|Other|Non-Interventional|Non-Interventional
15957568|NCT03205709|Other|Computerized Cognitive Training|Computerized online cognitive training will be used to target specific cognitive abilities and neural networks to potentially improve cognitive functioning through neuroplasticity.
15957569|NCT03205709|Other|Crossword Puzzles|These are intended to mimic crossword puzzles in newspapers.
15957570|NCT03205696|Drug|Antiretrovirals|The antiretroviral (ARV) regimen provided by the clinician must follow DHHS guidelines for antiretroviral naïve adolescents and adults
15957571|NCT03205683|Other|Intraneural facilitation (INF)|INF is a novel non-invasive therapy based on the principle of restoring vascular function at the capillary level in peripheral nerve.
15957572|NCT03205683|Other|Sham INF|Will be performed by a different therapist than actual INF. The patient will be asked to do the following combination of passive range of motion (PROM) and active ROM activities to promote blood flow in the affected arm.
15957573|NCT03205670|Procedure|Urethroplasty with a tissue-engineered construct|The investigators will perform urethroplasty with the tissue-engineered construct - epithelial cells isolated from patient's buccal mucosa and seeded on a collagen-polylactoglycolide matrix.
15957574|NCT03205657|Procedure|auto transplant followed by allo transplant|patients who got MAC conditioning with auto SCT followed by RIC followed by alloSCT for mature B-NHL
15957575|NCT03205631|Other|Natural Frequency Patch|Participants will receive in randomized order the differing patches to wear during three nights separated by a washout period of 3-4 nights
15957576|NCT03205618|Other|Non-Interventional|Non-Interventional
15957577|NCT03205605|Drug|oxybutynin|patch
15957578|NCT03205605|Drug|oxybutynin|gel
15957579|NCT03205592|Diagnostic Test|Ultrasound examination of the antrum|Ultrasound assessment of gastric content will be performed : prior to suction of gastric content through a gastric tube (method to assess the residual gastric content volume), after this suctioning of gastric content, then after reinjection of the content suctioned into the stomach (max 250 ml) and 1h30 later
15957580|NCT03205579|Other|Video group|Using video for educate cancer pain patients
15957581|NCT03205579|Other|conventional group|Face to face cancer pain education by trained nurse
15957582|NCT03205566|Drug|Raltegravir 400Mg Tab|bd for 7 days
15957583|NCT03205566|Drug|Lamivudine 150Mg Tablet|+ Raltegravir 400Mg tablet bd for 7 days
15957584|NCT03205553|Procedure|SoC Staged Silo Closure|Serial reductions will be performed with silastic silo placement for staged reduction using umbilical tape ties. The silo is assessed daily on morning rounds by the surgical team. Once the abdominal contents are at the level of the fascia, the abdomen is closed in the operating room. The average day to closure historically from CHND data is 5 days.
15957585|NCT03205553|Drug|Peritoneal Dialysis Solution/Dextrose 1.5%|Serial reductions will be performed with silastic silo placement for staged reduction with adjuvant direct peritoneal resuscitation (DPR). A JP drain will be securely placed through the top of the silo beneath the fascia at the base of the small bowel mesentery for instillation of dialysate fluid and aspiration of peritoneal fluid. The sterile syringe will then be connected to the JP drain. The dialysate fluid administered via JP drain as a bolus infusion every 6 hours until the abdominal wall is closed (generally 3-5 days), but not to exceed 7 days maximum. Fluid will be warmed at bedside using dry heat not to exceed 37°C/98°F. The initial bolus infusion will be 10 mL/kg of dialysate. If tolerated, each subsequent infusion will be increased by 10 mL/kg up to a goal infusion of 40 mL/kg (to a maximum volume of 100 mL) as tolerated. Dialysate will dwell for 1 hour after instillation of fluid. Any excess fluid will then be removed via JP drain.
15957586|NCT03205540|Procedure|Continuous epidural block|Continuous epidural block at level L2-3 or L3-4 with 0.0625% bupivacaine + fentanyl 2 mcg/ml infusion epidurally 5 ml/hr for 48 hours postoperatively.
15957587|NCT03205540|Procedure|Bilateral single-shot bilateral adductor canal blocks|Bilateral single-shot adductor canal blocks, ultrasound guidance, with 0.33% bupivacaine 15 ml on each side.
15957588|NCT03205527|Other|Overground slip perturbation training|Slips will be induced by a low-friction platform (65×30×0.6 cm, μ<0.05) embedded side-by-side in the walking path, set nearly flush with the floor surround. The moveable platform, mounted on top of a pair of force platforms (AMTI, Newton, MA) for measuring ground reaction forces is firmly locked in a stationary position. An unannounced release occurs at heel strike of the perturbed, without the knowledge of subject, after which the platform is free to slide up to 150 cm. The mechanical release is controlled by the loading on the force platforms and the computer.
15957589|NCT03205514|Diagnostic Test|NSTE-ACS with intermediate stenosis and negative FFR|Patients will undergo intracoronary imaging evaluation with IVUS-NIRS and OCT, endothelial function and inflammatory state evaluation.
15957590|NCT03205501|Drug|IV-administation of EMI-137|Intravenous administration of 0.13 mg/kg of the fluorescent tracer EMI-137 approximately 2.5 hours prior to the endoscopy procedure.
15957591|NCT03205501|Device|Molecular Fluorescence Endoscopy platform|A flexible fluorescence fiber-bundle is attached to a fluorescence camera platform to enable the detection of fluorescence signals. The fluorescence fiber-probe is inserted through the standard working-channel of the standard clinical endoscope. Fluorescence imaging will be performed prior to and post the endoscopic resection, during the same endoscopy procedure.
15957592|NCT03205488|Drug|Cohort 1:Nilotinib Oral Capsules (150mg or 300mg)|2 capsules taken once daily
15957593|NCT03205488|Drug|Cohort 2: Nilotinib Oral Capsules (dose to be determined from Cohort 1)|2 capsules taken once daily
15957594|NCT03205488|Drug|Placebo|2 capsules taken once daily
15957595|NCT03205475|Behavioral|Alternate Coaching and Video Feedback Phase 1|Alternates each week between live/tele-health coaching (coaching) or Video review and call (feedback)
15957596|NCT03205475|Behavioral|Weekly Coaching in Phase 1|Weekly coaching (live or telehealth)
15957597|NCT03205475|Behavioral|Weekly Coaching plus Intensive Refresher Course Phase 2|Continue weekly coaching with senior trainer and add one week intensive refresher course
15957598|NCT03205475|Behavioral|Weekly Coaching plus Peer Coaching Phase 2|Continue weekly coaching with senior trainer and add weekly peer coaching from another interventionist in the region who is at high fidelity
15957599|NCT03205475|Behavioral|Video Feedback Only Phase 2|Receive video feedback and calls only
15957600|NCT03205462|Drug|Fluorothyazinone 300 mg|Fluorothyazinone in a dosage of 300 mg (1 tablet)
15957601|NCT03205462|Drug|Fluorothyazinone 600 mg|Fluorothyazinone in a dosage of 600 mg (2 tablets) is received per os (oral administration) as a single dose
15957602|NCT03205462|Drug|Fluorothyazinone 3900 mg|The total dose of Fluorothyazinone per treatment course is 3900 mg.
15957646|NCT03205150|Drug|LIK066|Film coated tablet of LIK066 either 30mg or 150 mg was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84
15957647|NCT03205150|Drug|Placebo|LIK066 0 mg film-coated tablet(Placebo matching tablets) was mostly administered once daily before lunch, except on Day 56 when it was administered before breakfast and in fasted state on Day 84.
15957603|NCT03205449|Behavioral|Masayang Pamilya Para Sa Batang Pilipino Parenting Programme (MaPa)|The MaPa programme includes the following content: 1) spending one-on-one time with children; 2) describing actions and feelings for cognitive development and socio-emotional awareness; 3) using praise and rewards to encourage positive behaviour; 4) establishing limits through effective instruction giving and consistent household rules; 5) nonviolent discipline such as ignoring negative attention seeking behaviour, and consequences for noncompliance, rule-breaking, and aggressive behaviour; 6) problem solving with children; and 7) mindfulness based stress reduction for caregivers.
15957604|NCT03205449|Other|Parenting Effectiveness Service|Content uses a thematic manual that includes sessions on Filipino family dynamics, early childhood development, child behaviour management, marital relationships, prevention of child maltreatment, health care, nutrition, and government anti-poverty initiatives, as well as disaster preparedness. [12].
15957605|NCT03205436|Other|Affinity human amniotic membrane|fresh hypothermically stored human amniotic membrane
15957606|NCT03205423|Drug|Gabapentin|Maintenance medication under investigation for its ability to alter the subjective and reinforcing effects of experimenter-administered doses of oxycodone and alcohol.
15957607|NCT03205410|Procedure|remote ischemic preconditioning|The remote ischemic preconditioning protocol described before began after anesthesia induction, and was completed prior to the start of surgery.
15957608|NCT03205410|Procedure|no - remote ischemic preconditioning|The sham - remote ischemic preconditioning protocol described before began after anesthesia induction, and was completed prior to the start of surgery.
15957609|NCT03205397|Other|Experimental Group|Preparation for anesthesia (explanations, film, booklet), the presence of a parent in the operating room and the awakening of the child
15957610|NCT03205397|Other|usual care|Usual care
15957611|NCT03205384|Procedure|surgery|
15957612|NCT03205371|Biological|MenACYW conjugate vaccine|Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine; 0.5 milliliter (mL), Intramuscular
15957613|NCT03205371|Biological|MMR|Measles, Mumps, and Rubella Virus Vaccine Live; 0.5 mL, Subcutaneous
15957614|NCT03205371|Biological|Varicella|Varicella Virus Vaccine Live; 0.5 mL, Subcutaneous
15957615|NCT03205371|Biological|DTaP-IPV-HB-Hib|Diphtheria, Tetanus, Pertussis (acellular component), Hepatitis B, Poliomyelitis (inactivated), and Haemophilus influenzae type-b conjugate vaccine (adsorbed); 0.5 mL, Intramuscular
15957616|NCT03205371|Biological|PCV13|Pneumococcal 13-valent Conjugate Vaccine; 0.5 mL, Intramuscular
15957617|NCT03205358|Biological|Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine|0.5 milliliter (mL), Intramuscular (IM)
15957618|NCT03205358|Biological|Meningococcal Polysaccharide groups A, C, W-135 and Y Conjugate Vaccine|0.5 mL, IM
15957619|NCT03205345|Drug|Emricasan (25 mg)|25 mg emricasan
15957620|NCT03205345|Drug|Emricasan (5 mg)|5 mg emricasan
15957621|NCT03205345|Drug|Placebo|Matching Placebo
15957622|NCT03205332|Behavioral|Concreteness Training|
15957623|NCT03205319|Device|e-learning|The e-learning for patients is a user friendly, audiovisual based, online-accessible program, designed especially for this study. The e-learning will contain information on dyspepsia and advice on lifestyle interventions
15957624|NCT03205293|Behavioral|Intervention Program to Promote Healthy Eating and Physical Activity among Palestinian Female Schoolchildren|
15957625|NCT03205267|Drug|Bosulif|Patients will start with dose-level 1 (300 mg once daily) Bosutinib. If patients do not experience any toxicity or only G1 toxicity, they will be dose-increased first to dose-level 2 (400 mg once daily ) and then to dose-level 3 (500 mg once daily). Dose will not be escalated above 500 mg which is the dose recommended by the summary of product information. If patients experience G2 toxicity, the study drug will be further continued at the same dose-level. In patients with G3 or G4 toxicities, therapy will be withheld until toxicity resolved to <G2.
15957626|NCT03205254|Other|Mediterranean Diet|four days of participant-scaled isocaloric Mediterranean meals
15957627|NCT03205254|Other|Fast food diet|four days of participant-scaled isocaloric fast food meals
15957628|NCT03205241|Dietary Supplement|n-3 PUFA|n-3 PUFA capsules containing EPA and DHA
15957629|NCT03205241|Dietary Supplement|Placebo|Olive oil capsules
15957630|NCT03205228|Drug|Omeprazole|A capsule of Omeprazole 20 mg & 1 capsule of placebo will be given in individual subject, once daily for 4 weeks. Both drugs will be presented in the same appearance (white capsule).
15957631|NCT03205228|Behavioral|psychoeducation|Psychoeducation will be given by psychologists at the Day 1 and Day 15 of the study period.One white capsule of placebo will be given once daily for 4 weeks of the study period.
15957632|NCT03205228|Drug|Flupentixol +Melitracen|A capsule containing of a tablet of melitracen 10 mg + flupentixol 0.5 mg & a capsule of placebo will be given once daily, for 4 weeks. Both would be presented in the same appearance (white capsule)
15957633|NCT03205215|Other|Hyperbaric Oxygen Therapy|100% oxygen delivered by hood at 2 ATA for 90 minutes with 5 minute air breaks
15957634|NCT03205215|Other|Waitlist Hyperbaric Oxygen Therapy|100% oxygen delivered by hood at 2 ATA for 90 minutes with 5 minute air breaks
15957635|NCT03205202|Dietary Supplement|Cocoa extract|
15957636|NCT03205202|Dietary Supplement|Multivitamin|
15957637|NCT03205202|Dietary Supplement|Cocoa extract placebo|
15957638|NCT03205202|Dietary Supplement|Multivitamin placebo|
15957639|NCT03205189|Other|Comparison between pre-operative prescription and post-operative prescription|The first group will have a pre-operative prescription delivered during the preoperative anesthesia clinic and the second group will receive the postoperative prescription.
15957640|NCT03205176|Drug|AZD5153|AZD5153 is to be taken as oral capsules once or twice per day each day in 21 day cycles. Dosing will continue until disease progression or other study discontinuation criteria are met.
15957641|NCT03205176|Drug|Olaparib|Olaparib, 300 mg, will be taken BID as oral capsules.
15957642|NCT03205163|Biological|Advate (Low Dose)|Participants received a single IV low dose of Advate 25 IU/kg.
15957643|NCT03205163|Biological|Advate (High Dose)|Participants received a single IV high dose of Advate 65 IU/kg.
15957644|NCT03205163|Biological|BIVV001 (Low Dose)|Participants received single IV low dose of BIVV001 25 IU/kg.
15957645|NCT03205163|Biological|BIVV001 (High Dose)|Participants received single IV high dose of BIVV001 65 IU/kg.
15957648|NCT03205137|Drug|subjects treated with telmisartan/hydrochlorothiazide|subjects treated with telmisartan/hydrochlorothiazide
15957649|NCT03205137|Drug|Subjects treated with Telmisartan and amlodipine|Subjects treated with Telmisartan and amlodipine
15957650|NCT03205137|Drug|subjects treated with Telmisartan+hydrochlorothiazide double-pill combination group|subjects treated with Telmisartan+hydrochlorothiazide double-pill combination group
15957651|NCT03205137|Drug|subjects treated with telmisartan+amlodipine double pill|subjects treated with telmisartan+amlodipine double pill
15957652|NCT03205124|Procedure|Electrical Stimulation|"The experimental treatment involves implantation of 2 sterilized fine-gauge Teflon coated wires percutaneously. The ends of the wire are stripped for conductivity. Electrical stimulation is given at a fixed continuous frequency of 20Hz. The stimulus intensity is the maximum tolerable limit. The wires are then taped to the skin with surgical wound tape at a location away from the wound for strain relief. To ensure sterility, care is taken to dress the sutured wound and hand, as well apply the splint.
~The wires are removed either immediately at the conclusion of the pre-operative appointment and immediately after surgery or at the first surgical follow-up with dressing change, within one week of surgery."
15957653|NCT03205124|Procedure|Sham Stimulation|"The experimental treatment involves implantation of 2 sterilized fine-gauge Teflon coated wires percutaneously. The ends of the wire are stripped for conductivity. Electrical stimulation is begun until the patient senses the stimulation, then the stimulation is discontinued.The wires are then taped to the skin with surgical wound tape at a location away from the wound for strain relief. To ensure sterility, care is taken to dress the sutured wound and hand, as well apply the splint.
~The wires are removed either immediately at the conclusion of the pre-operative appointment and immediately after surgery or at the first surgical follow-up with dressing change, within one week of surgery."
15957654|NCT03205098|Biological|Blood analysis|Blood test of biological markers of mesenteric ischemia
15957655|NCT03205085|Radiation|magnetic resonance imaging|assessment of right heart dimensions and function by cardiac magnetic resonance Imaging.
15957656|NCT03205085|Procedure|2D and 3D trans-thoracic echocardiography|assessment of right heart dimensions and function by 2D and 3D trans-thoracic echocardiography
15957657|NCT03205085|Other|Blood samples|Blood samples for assays of immune inflammatory biomarkers (InterLeukin-18, CXCL9 or interferon
15957658|NCT03205072|Device|Spy Glass DS|The SpyScope™ DS Access and Delivery Catheter (SpyScope™ DS Catheter) is a sterile, single-use endoscope that enables access and delivery of accessories to targeted pancreaticobiliary anatomy and displays live video when connected to a Spy Glass DS Digital Controller.
15957659|NCT03205059|Behavioral|LST MS curriculum+ Bullying/Cyberbulling serious game|The prevention materials for middle school bullying and cyberbullying will (1) utilize both interactive classroom sessions and serious/educational games (digital games used to educate in an entertaining format); (2) positively change social norms surrounding bullying and cyberbulling; (3) challenge positive expectancies about bullying and cyberbullying; (4) enhance protective factors by building social, self-regulation, and relationship skills throughout the interactive learning and behavioral rehearsal; and (5) include booster sessions.
15957660|NCT03205059|Behavioral|LST MS curriculum|The evidence-based LifeSkills Training program has been successfully used as a universal, school-based substance abuse and violence prevention program for middle school youth. The goals of the LST program are to teach youth the personal self-management skills, social skills, and other life skills needed to successfully resist drug and alcohol use, navigate developmental tasks, increase resilience, and facilitate healthy psychosocial development.
15957661|NCT03205046|Drug|acalabrutinib|Acalabrutinib is a selective, irreversible small molecule Bruton's tyrosine kinase (BTK) inhibitor.
15957662|NCT03205046|Drug|vistusertib|Vistusertib is an inhibitor of mechanistic target of rapamycin (mTOR) kinase
15957663|NCT03205033|Drug|Melatonin 20 MG Oral Capsule|1 capsule/day 1 hour before go to bed
15957664|NCT03205033|Drug|Placebo oral capsule|1 capsule/day 1 hour before go to bed
15957665|NCT03205020|Diagnostic Test|serum amyloid a test|"Women who are diagnosed with preterm labor (28-36 weeks) will be enrolled in this study. Serum samples will be collected from all women before any intervention. All women will be sampled once at the time of admission.
~Venous blood sample (5 c.c) will be taken from each participant for examination of serum amyloid A.
~The collected blood will be centrifuging and serum will be stored to measure the level of amyloid A by (ELISA) technique in clinical pathology department- Ain shams University"
15957666|NCT03205007|Behavioral|Health promotion nutrition program|Health promotion nutrition program
15957667|NCT03204994|Drug|Indocyanine Green|Fluorescence guided lymphatic mapping using indocyanine green.
15957668|NCT03204981|Device|Intramural Needle Ablation|The needle-tipped ablation catheter that will be used for the IN ablation uses radiofrequency like a standard RF ablation catheter, but delivers energy through an extendable/retractable needle.
15957669|NCT03204981|Procedure|Ablation|standard ablation
15957670|NCT03204968|Device|Vagus nerve stimulation|transcutaneous Intermittent stimulation of the vagus nerve using neurostimulator V (Ducest®, Germany)
15957671|NCT03204955|Drug|Sodium chloride /sodium acetate (16.4%)|"Sodium Acetate is a sterile, nonpyrogenic solution of Sodium Acetate intended as an alternative to sodium chloride to provide sodium ion in parenteral (IV) fluid therapy.
~Sodium Chloride is sterile, nonpyrogenic hypertonic saline (concentrated sodium-chloride) solution for parenteral (IV) fluid therapy."
15957672|NCT03204955|Drug|Sodium chloride (23.4%)|Sodium Chloride is sterile, nonpyrogenic hypertonic saline (concentrated sodium-chloride) solution for parenteral (IV) fluid therapy.
15957673|NCT03204955|Drug|PlasmaLyte|PlasmaLyte is an isotonic IV solution that mimics human physiological plasma electrolyte concentrations, osmolality and pH.
15957674|NCT03204942|Device|PRF on DRG|RF will be performed with the patient in a prone position with mild flexion of the spine. Fluoroscopy beam positioned in an antero-posterior direction. A 10 cm RF needle 20 G with a 10 mm active tip.The needle is inserted in a slightly medial-cephalad direction under the transverse processes, and using lateral fluoroscopic imaging, incrementally walking into the thoracic intervertebral foramen. So the location of the needle tip confirmed by sensory stimulation at 50 Hz. The point of maximum stimulation is at 0.5 V intensity and this is designated to be the location of the DRG. Slight redirection can be done to optimize the stimulation; injection of contrast reveals epidural uptake. After establishing the site for the RF, 1 ml 2% lidocaine should be injected through the needle.
15957675|NCT03204942|Device|TRF on DRG|"Similar to the group of  PRF on DRG, but the types of the waves will be different as previously described"
15957676|NCT03204942|Drug|Corticosteroid injection|Similar to the previous groups, but without applying any type of Radio-frequency but just injecting steroids and local anesthetics as previously described
15957677|NCT03204929|Drug|Cu(II)ATSM|copper-containing synthetic small molecule
15957678|NCT03204916|Behavioral|Discussion|Participate in focus group
15957679|NCT03204916|Other|Medical Chart Review|Data abstraction and central review
15957680|NCT03204916|Other|Questionnaire Administration|Complete questionnaire
15957681|NCT03204903|Procedure|Laser acupuncture|Subjects were treated 3 times per week for 12 weeks with the LaserPen (GaAlAs laser diode, 810 nm, 150 mW, pulsed waves), which delivered 0.375 J of energy (5 s) to BL2, TE23, ST2, LI4, ST36, and GB37.
15957682|NCT03204903|Procedure|Sham laser acupuncture|Subjects were treated 3 times per week for 12 weeks with the LaserPen without laser output (5 s) to BL2, TE23, ST2, LI4, ST36, and GB37.
15957683|NCT03204890|Other|Transcutaneous Posterior Tibial Nerve Stimulation|Three (3) sessions per week for twelve (12) consecutive weeks, with a duration of 30 minutes each, with the application of 20 Hertz with a pulse amplitude of 200 MI sec. in each session. The intensity will be applied individually for each patient depending on the tolerance of the individual. In each session, it is normal to have plantar flexion of the foot and flexion of the first toe, and after the session and particularly during the first sessions there is the possibility of muscle pain, which should be tolerable.
15957684|NCT03204877|Drug|Melatonin|Oral capsules
15957685|NCT03204877|Other|Placebo|Oral capsules
15957686|NCT03204864|Device|RLD Group|patients CS placement will be guided by RLD measurement. Physician will place the CS lead in the site of longest RLD with a stable and acceptable pacing threshold.
15957687|NCT03204864|Device|Conventional CS lead placement|Clinical Practice
15957688|NCT03204851|Device|Wound Healing|Microlyte Ag is a class-II medical device cleared by the FDA for prescription and over the counter use in humans with skin wounds.
15957689|NCT03204838|Genetic|IDH mutation test performed at diagnosis|Observation of the test result
15957690|NCT03204825|Device|Active TENS|TENS is a form of electrical stimulation that provides symptomatic pain relief that is used extensively within the health-care setting. It is a non-invasive modality; packaged in a small, portable unit that is easy to apply via small electrodes placed on the skin.
15957691|NCT03204825|Behavioral|Patient-Centred Education|Group education for patients with peripheral arterial disease and intermittent claudication about their condition, improving patient ownership, and promoting self-managed walking
15957692|NCT03204825|Device|Placebo TENS|TENS device use with setting so that the stimulation delivered is ineffective
15957693|NCT03204812|Biological|Durvalumab|Given IV
15957694|NCT03204812|Biological|Tremelimumab|Given IV
15957695|NCT03204799|Other|Metformin|newly diagnosed type 2 diabetes patients who start to metformin monotherapy
15957696|NCT03204799|Drug|SGLT2 inhibitor|newly diagnosed type 2 diabetes patients who start to SGLT2 inhibitor monotherapy
15957697|NCT03204799|Drug|ezetimibe|newly diagnosed dyslipidemia patients who start to ezetimibe therapy
15957698|NCT03204786|Drug|Vasopressin (USP) Injectable Solution [Vasostrict]|Nasal Spray
15957699|NCT03204786|Drug|Placebo|Placebo Nasal Spray
15957700|NCT03204773|Diagnostic Test|EuroQol five dimensions questionaire (EQ-5D)|Testing quality of life.
15957701|NCT03204773|Diagnostic Test|Modified Fatigue Impact Scale (MFI)|Screening for fatigue
15957702|NCT03204773|Diagnostic Test|Brief Pain Inventory (BPI)|Testing for pain
15957703|NCT03204773|Diagnostic Test|Becks Depression Inventory (BDI)|Screening for depression
15957704|NCT03204773|Diagnostic Test|Restless-leg Questionaire (RLS diagnostic criteria)|Testing for restless-legs
15957705|NCT03204760|Drug|Dexamethasone 8Mg Solution for Injection|Effect single dose of intramuscular dexamethasone (0.6 mg/kg to a maximum of 18 mg) in the treatment of mild to moderate acute asthma exacerbations in children
15957706|NCT03204760|Drug|Prednisolone Oral, Per 5 Mg|Effect of prednisolone for 3 days (1 mg/kg to a maximum of 40 mg), given orally in two devided doses in the treatment of mild to moderate acute asthma exacerbations in children.
15957707|NCT03204747|Other|Observational study : gait speed|No intervention, only propose water and wait for need to void
15957708|NCT03204734|Drug|Capecitabine|Capecitabine will been given as a sequential treatment who are got benefit in capecitabine-base chemotherapy.
15957709|NCT03204734|Drug|endocrine therapy|endocrine therapy will been given as a sequential treatment who are got benefit in capecitabine-base chemotherapy.Endocrine therapy is determined by the doctor, including any kind of letrozole, anastrozole, exemestane, fulvestrant, tamoxifen, toremifene, combined with or without drugs or surgery in the inhibition of ovarian function.
15957710|NCT03204721|Other|Extracorporeal photophoresis (ECP)|The treatment procedure of ECP consists of three steps. First, the leukocytes are removed by apheresis; second, the mononuclear cells are primed with the photosensitizing agent 8-methoxypsoralen; then third, these cells are exposed to radiation with ultraviolet A light before they are re-infused into the patient
15957711|NCT03204708|Device|catheter|catheter was placed under clavipectoral fascia by open technique by surgeon at the 1/3 lateral part of clavicula neighbourhood of nervus thoracicus longus, nervus thoracodorsalis, nervus pectoralis lateralis, nervus pectoralis medialis
15957712|NCT03204708|Drug|iv analgesia|patients were given 100 ml of tramadol 30 minutes before extubation
15957713|NCT03204695|Device|Percutaneous LAA Closure|LAA Closure with the WaveCrest LAA Occlusion System (study device)
15957714|NCT03204682|Device|Repetitive transcranial magnetic stimulation|Realization of a brain and medullary MRI to allow neuronavigation. Realization of 5 sessions of rTMS in 5 days during the first week then evaluation (physical examination, questionnaires) in consultation on post-stimulation. Then followed for 28 days in total through self-assessment of pain that will be filled daily on REDCap and last consultation on D28 for further evaluation
15957715|NCT03204669|Other|Trace elements replacement|
15957716|NCT03204643|Behavioral|BH-VPN|A bundle of usual care components, applied consistently and completely, along with access to behavioral health specific patient navigators and navigation services.
15957717|NCT03204630|Dietary Supplement|Lfer|Probiotic bacteria originally isolated from breast milk: the strain Lactobacillus fermentum CECT5716
15957718|NCT03204630|Dietary Supplement|Bifido|Probiotic bacteria originally isolated from breast milk: the strain Bifidobacterium breve CECT7263
15957719|NCT03204630|Other|Control|Standard infant formula
15957720|NCT03204617|Biological|DNA.HTI 0.5mL at weeks 0, 4 and 8 + MVA.HTI 0.5mL at weeks 12 and 20 (DDDMM)|Vaccine DNA.HTI 0.5mL at weeks 0, 4 and 8 + Vaccine MVA.HTI 0.5mL at weeks 12 and 20 (DDDMM).
15957721|NCT03204617|Biological|At least 24 weeks since DDDMM, ChAdOx1.HTI 0.5mL at weeks 0 and 12 + MVA.HTI 0.5mL at week 24 (CCM)|At least 24 weeks since second MVA.HTI administration (week 20), administration of ChAdOx1.HTI 0.5mL at weeks 0 and 12 + MVA.HTI 0.5mL at week 24.
15957722|NCT03204617|Drug|Placebo|0.9% sterile normal saline solution at weeks 0, 4, 8, 12 and 20. At least 24 weeks since the fifth Placebo administration, 0.9% sterile normal saline solution at weeks 0, 12 and 24
15957723|NCT03204604|Dietary Supplement|Challenge A - low calorie Ensure®|Challenge A will include a low calorie Ensure shake for the participant to drink with no ketone esters (KE).
15957724|NCT03204604|Dietary Supplement|Challenge B - Ensure® plus ketone esters (KE)|Challenge B will include an Ensure shake for the participant to drink with deltaG ketone ester, which has generally recognized as safe (GRAS) supplement status .
15957725|NCT03204604|Procedure|PET Scan|Subject will drink the shake. Immediate recall memory testing. Subject will be placed in the scanner. Prior to PET acquisition, a low dose CT scan of the head will be obtained for attenuation correction. Patients will be injected with an intravenous bolus of up to 5-10mCi (370 MBq) (+/- 10%) of [11C]AcAc (over 2 minutes). This is the standard dose used in published clinical studies using [11C]AcAc. The PET acquisition will begin immediately after the tracer injection and last for a total of 30 minutes. 2 ml of blood will be sampled from the forearm vein at 3, 6, 8, 12, 20, and 28 minutes post [11C]AcAc tracer injection. This will be used for quantification of radiation estimates throughout the scan-period
15957726|NCT03204604|Behavioral|Cognitive Testing - FCSRT|The Free and Cued Selective Reminding Test (FCSRT) measures verbal memory through multiple trials of a list learning task. A list of 16 items is visually presented to the participants, who then recall as many items as possible. On subsequent trials, participants are told only those items they omitted on the previous trial. The procedure continues until the participant recalls all items on two subsequent trials. After approximately 30-minute delay, participants are asked to recall as many items as possible. The number of items recalled after the delay is then summed.
15957727|NCT03204604|Behavioral|Story Recall|Story Recall: This test is a modification of the episodic memory measure from the Wechsler Memory Scale-Revised (WMS-R). In this modified version, free recall of one short story that consists of 44 bits of information will be elicited immediately after it is read aloud to the participant and again after a thirty-minute delay. The total bits of information from the story that are recalled immediately (maximum score = 44) and after the delay interval (maximum score = 44) are recorded. Six comparable versions of this task have been validated in prior studies with older adults.
15957728|NCT03204604|Behavioral|BVRT|Benton Visual Retention Test (BVRT): The BVRT is a multiple-choice visual recognition task. Participants view a visual pattern and are then asked to select the target from an array of four patterns, three of which are distractors. It assesses visuospatial working memory. This recognition format has the advantage assessing visual memory while eliminating the influence of visuomotor and manual dexterity difficulties.
15957729|NCT03204604|Behavioral|CogState One Card Learning|The One Card Learning Test involves a visual learning task sensitive to early-stage cognitive impairment. It is one of several computerized assessments developed by CogState that assess executive function and working memory.
15957730|NCT03204591|Other|No intervention|No intervention
15957731|NCT03204578|Drug|AB (Midazolam OD formulation/Dormicum)|Oral disintegrating formulation (Midazolam OD Formulation). The Midazolam OD Formulation was developed by Kyukyu Pharmaceutical Co., Ltd
15957732|NCT03204578|Drug|BA (Dormicum/Midazolam OD formulation)|Oral disintegrating film (Midazolam OD Formulation). The Midazolam OD Formulation was developed by Kyukyu Pharmaceutical Co., Ltd
15957733|NCT03204565|Procedure|coronally advanced flap|coronally advanced flap alone (CAF- control)
15957734|NCT03204565|Device|hyaluronic acid|hyaluronic acid associated to coronally advanced flap (CAF + HA- test)
15957735|NCT03204552|Other|No intervention (observational study)|No intervention (observational study)
15957736|NCT03204539|Drug|Wilate|Wilate® is a high-purity (i.e. 100 IU FVIII/mg total protein) pdVWF/FVIII complex concentrate.Wilate® possesses all the important features asked for in ITI, namely high purity, a very high pathogen safety profile, and an excellent protection of its FVIII by VWF - all achieved through unique, novel, and innovative techniques.
15957737|NCT03204526|Device|deep brain stimulation|
15957738|NCT03204513|Device|Vanderbilt Powered Knee-Ankle Prosthesis|The Vanderbilt powered prosthesis is a transfemoral prosthesis with powered and coordinated knee and ankle joints. The Generation 3 prosthesis is actuated by two brushless direct current (DC) motors, providing up to 100 Nm of torque at the knee joint, and with the assistance of a parallel stiffness, up to 200 Nm in plantar flexion at the ankle. Sensors measure knee and ankle joint angles, axial load in the shank, and position and orientation of the prosthesis in space (via a 6-axis inertial measurement unit). An onboard lithium-ion battery provides sufficient energy for approximately 10,000 steps between battery charges. The prosthesis prototype weighs approximately 4.3 kg (9.5 lb), the mass of which is approximately equivalent to the intact limb of a 48 kg (105 lb) person.
15957739|NCT03204513|Device|Microprocessor (MP) Knee Prosthesis|Participants enrolled will already have their own microprocessor controlled (MP) non-powered knee prostheses as per inclusion criteria. Examples: OttoBock's C-Leg, Ossur's Rheo, Freedom Plie, Endolite Orion,etc.
15957740|NCT03204500|Combination Product|Active treatment with dual therapy|Blue pills ( 200 mg of magnesium valproate ) and white pills ( 300 mg of lithium carbonate) are administered orally with meals.
15957741|NCT03204500|Drug|Placebos|Administered orally under the same conditions
15957742|NCT03204487|Drug|Tafluprost 15µg/ml|Tafluprost 15µg/ml (Saflutan® 15 microgram/ml Augentropfen im Einzeldosisbehältnis, Merck Sharp & Dohme, Wien)
15957743|NCT03204474|Drug|Lacosamide (LCM) tablet|Treatment A: Single dose of Lacosamide (LCM) 200 mg given as 2 tablets of LCM 100 mg
15957744|NCT03204474|Drug|Lacosamide (LCM) solution for infusion|Treatment B: Single dose of Lacosamide (LCM) 200 mg administered as intravenous infusion
15957745|NCT03204461|Diagnostic Test|Oral glucose tolerance test (OGTT)|For the assessment of glucose metabolism, including beta-cell function and insulin sensitivity an 75g-OGTT was conducted.
15957746|NCT03204461|Other|1H-magnetic resonance spectroscopy|The amount of ectopic lipids in the liver, heart and the skeletal muscle was measured using 1H-magnetic resonance spectroscopy.
15957747|NCT03204448|Device|BioCLIA Ro60|BioCLIA Ro60 is a Chemiluminescent Immuno Assay (CLIA) as a fully automated testing process, reporting with arbitrary units, RU/mL
15957748|NCT03204435|Procedure|Microsurgical aneurysmal operating techniques|The microsurgical techniques used to evacuate the aneurysm out of circulation or reduce its risk of rupture by aneurysmal clipping, wrapping,or isolation.
15957749|NCT03204435|Procedure|endovascular techniques for cerebrovascular stenosis|The endovascular techniques that recanalize the narrowed or occluded cerebrovascular, including stent implantation, balloon dilatation.
15957750|NCT03204435|Procedure|endovascular techniques for intracranial aneurysms|The endovascular techniques that embolize the cavity of aneurysms to reduce the risk of rupture, including coiling embolization, balloon-assisted occlusion.
15957751|NCT03204435|Procedure|carotid endarterectomy|A microsurgical technique to recanalize the stenosis or occluded proximal segment of carotid artery.
15957752|NCT03204422|Other|No intervention|no any other intervention
15957753|NCT03204396|Drug|Dulaglutide|Application of Dulaglutide (Trulicity®) 1.5 mg s.c. once weekly for 12 weeks.
15957754|NCT03204396|Drug|0.5 ml normal saline (0.9% sodium chloride [0.9% NaCl])|Application of 0.5 ml normal saline (0.9% sodium chloride [0.9% NaCl]) once weekly for 12 weeks
15957755|NCT03204370|Drug|Elosulfase Alfa 1 MG/ML Intravenous Solution [VIMIZIM]|A subgroup of MPS4A patients will be treated by VIMIZIM drug, prescribed in usual care
15957756|NCT03204357|Other|Fresh Autologous whole Blood|Subjects randomized this arm will receive fresh autologous whole blood
15957757|NCT03204357|Other|Standard of Care Expectant management of bleeding|the control group that will receive the standard of care expectant management of bleeding and transfusion of allogenic banked blood products
15957758|NCT03204344|Dietary Supplement|Oral carbohydrate (Outfast)|"For all patients, 2 bottles of oral carbohydrate (Outfast, 710 ml) is provided between 22:00-24:00 on the day before surgery. Subcutaneous insulin is administered before drinking. The dose of insulin is calculated by an endocrinologist according to patients' daily glucose controlling plan.
~For patients who entered operating room before 12:00, 1 bottle of oral carbohydrate (Outfast) is provided at 6:00 on the day of surgery. For patients who enter the operating room after 12:00, another bottle of oral carbohydrate (Outfast) is provided at least 2 hours before entering the operating room. Subcutaneous insulin is administered before drinking. The dose of insulin is calculated is the same way as described above."
15957759|NCT03204344|Other|Routine fasting|"For all patients, routine fasting (water drinking allowed) begin from 22:00 on the day before surgery until entering the operating room on the day of surgery.
~For patients who enter the operating room before 12:00, no oral or intravenoous fluid is provided. For patients who enter the operating room after 12:00, 5% glucose (500-1000 ml) is provided by intravenous infusion from 6:00 on the day of surgery. Intravenous insulin is added in the 5% glucose (glucose:insulin=4-6:1). Electrolytes (such as sodium chloride, potasium chloride, and magnesium sulfate) are added when considered necessary."
15957760|NCT03204331|Drug|Relugolix|Relugolix 40-mg tablet administered orally once daily.
15957761|NCT03204331|Drug|Estradiol/norethindrone acetate|Capsule containing co-formulated tablet of E2 (1.0 mg)/NETA (0.5 mg) administered orally once daily.
15957762|NCT03204331|Drug|Estradiol/norethindrone acetate placebo|E2 (0 mg)/NETA (0 mg) placebo capsule administered orally once daily and designed to match the E2/NETA capsule in size, shape, color, and odor.
15957763|NCT03204331|Drug|Relugolix placebo|Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.
15957764|NCT03204318|Drug|Relugolix|Relugolix 40-mg tablet administered orally once daily.
15957765|NCT03204318|Drug|Estradiol/norethindrone acetate|Capsule containing co-formulated tablet of E2 (1.0 mg)/NETA (0.5 mg) administered orally once daily.
15957766|NCT03204318|Drug|Estradiol/norethindrone acetate placebo|E2 (0 mg)/NETA (0 mg) placebo capsule administered orally once daily and designed to match the E2/NETA capsule in size, shape, color, and odor.
15957767|NCT03204318|Drug|Relugolix placebo|Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.
15957768|NCT03204305|Drug|11C-OMAR|11C-OMAR is a PET radiotracer that binds to cannabinoid type 1 receptors (CB1R). It is an analog of the CB1R antagonist/inverse agonist rimonabant. 11C-OMAR was developed, synthesized and validated for inhuman use at the Johns Hopkins University PET center.
15957769|NCT03204305|Drug|Cannabis|Cannabis will be administered to cannabis users. Doses include 0 and 25 mg THC.
15957770|NCT03204279|Drug|Netupitant|Netupitant 1.33 mg/kg oral suspension up to a maximum of 100 mg
15957771|NCT03204279|Drug|Palonosetron|Palonosetron 20 μg/kg solution for oral use up to a maximum of 1.5 mg
15957772|NCT03204279|Drug|Netupitant|Netupitant 4 mg/kg oral suspension up to a maximum of 300 mg
15957773|NCT03204279|Drug|Palonosetron|Palonosetron 20 μg/kg solution for oral use up to a maximum of 1.5 mg
15957774|NCT03204266|Drug|Arginine recovery supplement|Participants take 1 ounce (30mls) of Arginine recovery supplement four times daily 5 days preoperatively and 14 days postoperatively.
15957775|NCT03204266|Dietary Supplement|Omega-3 Fatty Acids|Participants given omega-3 fatty acids, 1 gram four times a day, 4 grams total per day. This will be started 7 days preoperatively and continued 14 days postoperatively.
15957776|NCT03204253|Drug|rFSH + r-LH in combination|29 women stimulated with rFSH supplemented by rLH in the late follicular phase started at the same time of starting the antagonist administration.
15957777|NCT03204253|Drug|rFSH alone|32 women who were stimulated with recombinant FSH alone
15957779|NCT03204227|Biological|JEVAX|JEVAX - VABIOTECH Vietnam Liquid form Subcutaneous injection 0.5ml/dose, 2 doses, 28-34 days interval
15957780|NCT03204227|Biological|JECEVAX|JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 28-34 days
15957781|NCT03204201|Drug|Indocyanine Green Solution|Urethral instillation of ICG (Indocyanine Green) mixed with urethral lubricant
15957782|NCT03204188|Drug|Ibrutinib|Ibrutinib
15957783|NCT03204188|Drug|Fludarabine|Fludarabine
15957784|NCT03204188|Drug|Pembrolizumab|Pembrolizumab
15957785|NCT03204175|Other|FIT Plus|"Group handwashing facilities
~Daily group handwashing and toothbrushing activities
~Sanitation operation and maintenance manuals for school officials
~Toilet cleaning consumable
~Toilet and handwashing station maintenance kits
~Soap, toothbrushes, and toothpaste"
15957786|NCT03204175|Other|Comparator arm|This is the same intervention as FIT Plus, but will be delivered to schools following endline data collection
15957787|NCT03204162|Other|CPR Coaching|Teams in the experimental arm will have a member of their team assigned to be the CPR Coach. This person will provide CPR Coaching in the form of feedback in CPR quality (depth, rate) to the CPR providers as well as provide guidance on time for defibrillation, etc.
15957788|NCT03204149|Device|MC-8XL low level laser device and Standard wound care|"The MC-8XL, a handheld Low Level Laser Therapy (LLLT) device, comprised of an infrared laser diode that generates wavelength of 808 nm and a green laser diode with a wavelength of 525 nm will be used to treat the experimental group.
~Along with the active LLLT, generally accepted standard wound care procedures will be used during the clinical trial by a qualified study nurse or doctor. These procedures will include wound cleaning and drying before irradiation with the laser device (sham or active). Each ulcer will be also assessed and debrided if needed.
~After irradiation, each ulcer will be dressed with saline gauze dressing and offloaded."
15957789|NCT03204149|Device|Sham laser device and Standard wound care|"The Sham device is of similar appearance, emitting only green light for indication with a wavelength of 525 nm of a low power, with inactive IR laser which will be used in the Control group.
~Along with the sham device, the same generally accepted standard wound care procedures will be used."
15957790|NCT03204123|Drug|Ga-HBED-iPSMA PET|Patients will be injected with 100-300 MBq of 68Ga-HBED-iPSMA and after a waiting of 60-90 minutes patients will be scanned from mid-skull to mid-thigh.
15957791|NCT03204123|Diagnostic Test|PET/CT|PET/CT will be acquired using a GE 710 or 690 time-of-flight PET/CT scanner. Following a waiting period of 60-90 minutes post 68Ga-HBED-iPSMA administration, patients will be scanned from top of the skull to mid-thigh. Images will be acquired with patients in a supine position with their arms raised above their head. If patients cannot raise their arms above the head, the arms will be comfortably positioned and secured by the side of the patient. The PET may be combined with a CT scan as a PET/CT or a MRI scan as PET/MR.
15957792|NCT03204123|Diagnostic Test|MRI|Patients may undergo a diagnostic MRI of the prostate, other body parts or a whole-body MRI at the same imaging session as clinically indicated.
15957793|NCT03204097|Drug|placebo|Oral prophylaxis followed by placement of placebo gel
15957794|NCT03204097|Drug|Alendronate|Oral prophylaxis followed by placement of Alendronate gel
15957795|NCT03204097|Drug|Aloe Vera|Oral prophylaxis followed by placement of Aloe Vera gel
15957796|NCT03204084|Device|Low-temperature Plasma Surgery System|In pterygium surgery with fibrin glue(FG) and conjunctival autograft we use Low-temperature Plasma Surgery System(LTP)do the ablation of tissue and hemostasis.
15957797|NCT03204071|Drug|placebo gel|Oral prophylaxis followed by Placebo gel to be delivered in intrabody sites of chronic periodontitis subjects.
15957798|NCT03204071|Drug|Aloevera|Oral prophylaxis followed by placement of aloevera gel
15957799|NCT03204071|Drug|Metformin|Oral prophylaxis followed by placement of metformin gel
15957800|NCT03204058|Drug|Placebos|Oral prophylaxis followed by placement of placebo gel
15957801|NCT03204058|Drug|Rosuvastatin|Oral prophylaxis followed by placement of rosuvastatin gel
15957802|NCT03204058|Drug|Metformin|Oral prophylaxis followed by placement of metformin gel
15957803|NCT03204045|Drug|fentanyl|2 mL mixture of fentanyl with isotonic saline
15957804|NCT03204045|Drug|Oxycodone|2 mL mixture of oxycodone with isotonic saline
15957805|NCT03204045|Drug|control|isotonic saline 2 mL
15957806|NCT03204032|Drug|Tegafur|Tegafur 40-60mg po bid(d1-d14);
15957807|NCT03204032|Drug|Temozolomide|200mg po qd(d10-d14)
15957808|NCT03204032|Drug|Thalidomide|Thalidomide 100mg po qd(d1-d7) Thalidomide 200mg po qd(d8-d14) Thalidomide 300mg po qd(d15-d21)
15957809|NCT03204019|Drug|Tegafur and Temozolomide|Tegafur 40-60mg po bid(d1-d14); Temozolomide 200mg po qd(d10-d14)
15957810|NCT03204019|Drug|Tegafur and Temozolomide combined with Thalidomide|Tegafur 40-60mg po bid(d1-d14); Temozolomide 200mg po qe(d10-d14) Thalidomide 100mg po qd(d1-d7) /Thalidomide 200mg po qd(d8-d14)/Thalidomide 300mg po qd(d15-d21)
15957811|NCT03204006|Drug|Dexmedetomidine|Dexmedetomidine preinduction
15957812|NCT03204006|Drug|sterile saline|normal saline preinduction
15957813|NCT03203980|Other|Triple antithrombotic therapy|patients who are prescribed double antiplatelets agents and oral anticoagulation (except VKA)
15957814|NCT03203967|Procedure|Epidural morphine|2 mg of morphine (0.4 mg/ml morphine in 5 ml normal saline) is administered through the epidural catheter at the end of surgery.
15957815|NCT03203967|Procedure|Epidural placebo|5 ml normal saline is administered through the epidural catheter at the end of surgery.
15957816|NCT03203967|Procedure|Single femoral nerve block|Single femoral nerve block is performed with 20 ml 0.5% ropivacaine under the guidance of ultrasonography and nerve stimulator after surgery.
15957817|NCT03203967|Drug|Intravenous morphine analgesia|Intravenous morphine analgesia is provided with a patient-controlled analgesia pump which is established with 100 ml of 0.5 mg/ml morphine, programmed to deliver a 2 ml bolus with a lockout interval of 8-10 min and a background infusion of 0.5 ml/h.
15957818|NCT03203954|Behavioral|Standard Learning|Participants will complete repeat sessions of a computer-based learning task, and task performance and symptoms will be assessed.
15957819|NCT03203954|Behavioral|Guided Learning: Instructed statistics|Participants will complete repeat sessions of a computer-based learning task, and task performance and symptoms will be assessed.
15957996|NCT03202641|Procedure|PEEP ARDSnet|PEEP settings based on the low PEEP/high FiO2 table
15957820|NCT03203954|Behavioral|Guided Learning: Changing statistics|Participants will complete repeat sessions of a computer-based learning task, and task performance and symptoms will be assessed.
15957821|NCT03203941|Biological|Autologous Cord Blood Stem Cells|This is an individual patient expanded access protocol.
15957822|NCT03203928|Behavioral|Occupational Therapy Intervention for Women with ADHD|"The intervention will run for 7 weeks and consist of the following 1-hour sessions. Each intervention session will be facilitated by two CUMC occupational therapy students in each participant's home environment (or another environment of the participant's choosing such as the work or school environment).
~Implementation of organizational, time management, stress management, and sensory regulation strategies for the home, school/work, and community environments."
15957823|NCT03203915|Dietary Supplement|Chardonnay grape marc marc high polyphenol dose (120mg)|3 prepackaged capsules taken once in the morning with meal for 3 weeks. The total dose will be 120mg of total polyphenols
15957824|NCT03203915|Dietary Supplement|Chardonnay grape marc powder low polyphenol dose (75mg)|3 prepackaged capsules taken once in the morning with meal for 3 weeks. The total dose will be 75mg of total polyphenols
15957825|NCT03203915|Dietary Supplement|Placebo (0mg)|3 prepackaged capsules taken once in the morning with meal for 3 weeks. The total dose will be 0mg of polyphenols
15957826|NCT03203902|Other|Psychoeducation and Therapeutic Touch|6-week, 1-hour psychoeducation group followed by 30-minute therapeutic touch
15957827|NCT03203889|Behavioral|CRAFT-AI|Community Reinforcement Approach and Family Training (CRAFT) uses principles of operant conditioning to help a concerned significant other improve their own psychological functioning and influence the identified person with addiction to seek help
15957828|NCT03203889|Behavioral|TSF-CSO|In individual sessions, the counselor facilitates the CSO's affiliation and involvement in Nar-Anon or Al-Anon groups to work the steps.
15957829|NCT03203876|Biological|Lirilumab|Specified dose on specified days
15957830|NCT03203876|Biological|Nivolumab|Specified dose on specified days
15957831|NCT03203876|Biological|Ipilimumab|Specified dose on specified days
15957832|NCT03203863|Diagnostic Test|anthropometric measures of fatness|The aim of this study was to determine the discrimination capacity for cardiovascular risk factors of BMI, fat mass (FM), waist circumference (WC), and waist to height ratio (WHtR) in a population of Chilean children from Puente Alto County. Additionally, new cutoff points were established and compared with those described by other authors
15957833|NCT03203850|Drug|Deferasirox FCT|Taken orally once per day (QD)
15957834|NCT03203850|Procedure|Phlebotomy|according to investigator's decision
15957835|NCT03203837|Other|Plasma collection|We will be collecting plasma at 7 different timepoints in hepatocellular carcinoma patients that are treated with radioembolization.
15957836|NCT03203824|Dietary Supplement|dark chocolate|Participants will be provided Parliament dark chocolate (70% cocoa) from Redlands, CA. The Parliament chocolate is made with cacao and cane sugar. Each participant will be given half a piece (1.4 g) of dark chocolate to consume for this experiment over three minutes.
15957837|NCT03203824|Other|non dark chocolate|No dark chocolate will be given to this group during the procedures.
15957838|NCT03203811|Drug|HTI-2088|3 dose levels
15957839|NCT03203811|Drug|Placebo|placebo oral tablet
15957840|NCT03203798|Procedure|Training of pelvic floor muscles|The pelvic floor muscle training group will be composed of randomized women and participated for 12 weeks of intervention, where it was performed in groups of a maximum of 4 patients, starting in the first 4 weeks with 3 sets of 8 repetitions of contraction maintained for 5 seconds In antigravity postures, with two lying postures and one sitting posture, and evolving to the next 4 weeks for 3 sets with 10 repetitions of contraction maintained for 5 seconds being a lying posture, a seated posture and orthostatic posture in the last 4 weeks 3 Series of 12 repetitions of contraction maintained for 5 seconds in the gravitational postures, being one sitting posture and two orthostatic postures.
15957841|NCT03203798|Procedure|Hipopressive abdominal gymnastics|The hipopressiva abdominal gymnastics group will be composed of randomized women who participated for 12 weeks of intervention, where it was performed in groups of a maximum of 4 patients, being performed respecting the basic sequence of the exercise proposed by Marcel Caufriez: 1) Inspiration, 2) Maximum Expiration, 3) Diaphragmatic aspiration being performed 3 series of 8 to 12 repetitions. The exercises will be performed in groups of a maximum of 4 patients, starting in the first 4 weeks with 3 sets of 8 repetitions in antigravity postures, with two lying postures and one sitting posture, and evolving over the next 4 weeks to 3 sets with 10 repetitions A lying posture, a sitting posture and orthostatic posture, in the last 4 weeks 3 sets of 12 repetitions in the gravitational postures, being a sitting posture and two orthostatic postures.
15957842|NCT03203785|Dietary Supplement|Carbohydrate (maltodextrin)|maltodextrin flavored
15957843|NCT03203785|Other|Placebo|non-caloric drink
15957844|NCT03203772|Other|Immersive Virtual Reality|Participants will engage in virtual visualization therapy in an immersive virtual reality environment
15957845|NCT03203759|Other|Home hospitalization|See above
15957846|NCT03203759|Other|Traditional inpatient hospitalization|See above
15957847|NCT03203746|Drug|Lycopene + SRP|
15957848|NCT03203746|Procedure|SRP only|
15957849|NCT03203733|Device|Cooral™|An intraoral cooling device which is as effective as ice but with better patient comfort. The cooling device has the advantage that the water temperature can be modified. It enables that the unacceptable low temperatures that occur with ice cooling can be avoided.
15957850|NCT03203733|Other|cryotherapy|Oral cooling by ice chips or crushed ice or ice pop
15957851|NCT03203720|Behavioral|Brief Motivational Intervention|A brief motivational intervention centered around Motivational Interviewing (MI) techniques. Sessions are adjunct to standard clinical care, and focus on psychoeducation regarding treatment for bipolar disorder, and resolving ambivalence regarding taking medications for mood disorder.
15957852|NCT03203707|Behavioral|Interpersonal and Social Rhythm Therapy|The Brief IPSRT intervention for at-risk youth includes : 1) Psychoeducation about risk for BP ; 2) Social rhythm therapy (SRT) aiming to establish and maintain stable routines to protect against onset of mood symptoms in vulnerable individuals ; and 3) Interpersonal Psychotherapy (IPT) centering on the adolescent's feelings about having a parent with BP, and linking stressful family events to mood. The intervention is delivered in 8 in-person sessions over 6 months of treatment. Parents are involved in the psychoeducation sessions, and further involvement is determined as clinically appropriate based on age and developmental status.
15957853|NCT03203694|Behavioral|Walking|The walking program will consist of 45 minutes of walking (at a moderate pace) 5 days per week for 8 weeks.
15957854|NCT03203694|Behavioral|Lower body heating|This intervention consists of 60 minutes of lower body heating (40-42 degree C) 7 days per week for 7 days.
15957856|NCT03203668|Radiation|18F-choline PET/CT|18F-choline PET/CT imaging (neck, mediastinum)
15957857|NCT03203655|Behavioral|CareMessage™|Adult Obesity texting program, which sends a text message 3 to 5 times a week, encouraging lifestyle modifications (diet and exercise education, and behavioral strategies) that can lead to healthy weight loss.
15957858|NCT03203655|Behavioral|Control Condition|Control condition will receive an initial talk about weight loss but will not be enrolled in any program or intervention.
15957859|NCT03203642|Drug|Tesevatinib|A once daily dose of tesevatinib 50 mg in a round tablet form of white to off-white color.
15957860|NCT03203642|Drug|Placebo|A once daily dose of matching placebo.
15957861|NCT03203629|Device|Wearable Cardioverter Defibrillator (WCD)|Observe and compare the heart sound measurements recorded by the WCD
15957862|NCT03203616|Drug|KADCYLA 160 MG Injection|Kadcyla 160Mg Powder for Injection: 3.6 mg/kg iv every 3 weeks
15957863|NCT03203603|Other|No active intervention|This is a follow-up of a randomized trial. No active intervention is being given in the follow-up.
15957864|NCT03203590|Drug|Oral Navelbine + Carboplatin|The patient will be given Navelbine 60 mg/m2, p.o. day 1 and 8 of every cycle (21 days) plus carboplatin AUC 5, i.v. day 1 of every cycle.After 2 cycle we will evaluate their clinical response.Then operable patients will have surgery.
15957865|NCT03203590|Drug|Gefitinib|The patient will be given Gefitinib 250mg,p.o.,q.d. for 8 weeks.After 8 weeks we evaluate their clinical response.Then operable patients will have surgery.
15957866|NCT03203577|Procedure|Initiation of mechanical ventilation|In patient with chronic respiratory insufficient chronic mechanical ventilation will be initiated in the patient his/her setting.
15957867|NCT03203564|Drug|Modufolin (arfolitixorin)|Thirty-three eligible and consenting subjects will be included in 3 cohorts, 11 subjects in each cohort, Within each cohort, subjects will be randomized to receive either placebo (3 subjects) or Modufolin® for injection, 100mg (8 subjects)
15957868|NCT03203551|Other|Disinfection Protocol|The participants assigned to this group carried out the disinfection protocol that recommended brushing the palate (3 times a day), brushing the total prosthesis with neutral liquid soap (3 times a day) and immersing in different desinfection solutions (once a day/ 20 minutes)
15957869|NCT03203538|Device|LED-light, 1000 lux|Full-spectrum light, 1000 lux, 4000 K. Represent a light intensity within acceptable range (light that is not too glary); 4000 K is among the most commonly used indoor light colour temperatures.
15957870|NCT03203538|Device|LED-light, 100 lux|Full-spectrum light, 100 lux, 4000 K. Represent a light intensity within acceptable range (light that provides sufficient eye sight); 4000 K is among the most commonly used indoor light colour temperatures.
15957871|NCT03203538|Device|LED-light, 7000 K|Full-spectrum light, 7000 K, 200 lux. Represent the upper border of common colour indoor light temperature, 200 lux is a common indoor light intensity.
15957872|NCT03203538|Device|LED-light, 2500 K|Full-spectrum light, 2500 K, 200 lux. Represent the lower border of common colour indoor light temperature, 200 lux is a common indoor light intensity.
15957873|NCT03203538|Device|Blue LED-light|Blue light with peak wavelength 455 nm. Known to delay the circadian rhythm, suppress melatonin, and increase alertness.
15957874|NCT03203538|Device|Red LED-light|Red light with peak wavelength 615 nm. Known not to affect the circadian rhythm, melatonin, and alertness.
15957875|NCT03203525|Biological|Bevacizumab|Given IV
15957876|NCT03203525|Drug|Fluorouracil|Given via pump
15957877|NCT03203525|Drug|Leucovorin|Given via pump
15957878|NCT03203525|Drug|Oxaliplatin|Given via pump
15957879|NCT03203525|Drug|Pegylated Liposomal Doxorubicin Hydrochloride|Given IV
15957880|NCT03203525|Drug|Temsirolimus|Given IV
15957881|NCT03203525|Procedure|Tumor Treating Fields Therapy|Use NovoTTF-100L(P) system
15957882|NCT03203512|Dietary Supplement|Fish oil capsules|Each serving contains 360mg eicosapentaenoic acid (EPA), 270mg docosahexaenoic acid (DHA) and total supplement is 1.8 g per day n-3 PUFA for 12 weeks
15957883|NCT03203512|Dietary Supplement|High-oleic safflower oil capsules|High-oleic safflower oil capsules for 12 weeks
15957884|NCT03203499|Drug|ANS-6637 Oral Tablet|Ascending single doses administered orally.
15957885|NCT03203499|Drug|Placebo Oral Tablet|Placebo administered orally.
15957886|NCT03203486|Other|Mediterranean Diet|Participants were instructed to include vegetables, whole grains and fruits in their diet and increase fish, legumes and raw nut intake. Emphasis was given to extra virgin olive oil as the main added fat in meals. Particular attention was drained to decrease fermented dairy and poultry, with small amounts of red meat and homemade sweets. All participants were given meal plans in which the distribution of nutrients in relation to total caloric value was as follows: 40% of total energy as fat (50% as MUFAs), 20% as protein, 40% as carbohydrate, 300mg/d as dietary cholesterol and 20-30g fiber/d.
15957887|NCT03203473|Drug|Ipilimumab|YERVOY is thought to work with the body's immune system to increase the activity of T cells and cause the body to attack cancer cells
15957888|NCT03203473|Drug|Nivolumab|Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs
15957889|NCT03203460|Behavioral|High-intensity aerobic interval training (HIIT)|A 12-week, supervised, HIIT aerobic exercise program consisting of alternating vigorous- and low-intensity intervals
15957890|NCT03203447|Drug|suprachoroidal CLS-TA|suprachoroidal injection of CLS-TA
15957891|NCT03203447|Drug|suprachoroidal sham|sham suprachoroidal procedure
15957892|NCT03203447|Drug|Lucentis or Avastin|IVT anti-VEGF agent. Either a 0.5 mg intravitreal injection of Lucentis or 1.25 mg intravitreal injection of Avastin
15957893|NCT03203434|Diagnostic Test|Urinary volatile organic compound analysis|
15957929|NCT03203148|Diagnostic Test|Point-of-Care ACT|Comparison between two point-of-care devices for measurement of the activated clotting time
15958039|NCT03202446|Drug|Standard of Care|
15957894|NCT03203421|Biological|ChAdOx1 LS2|A viral vectored vaccine, using a chimpanzee adenovirus as a vector encoding malaria liver-stage dual antigen LS2 (LSA1 and LSAP2) fused with the transmembrane domain from shark invariant chain.
15957895|NCT03203421|Biological|MVA LS2|Modified vaccinia Ankara vector encoding liver-stage dual antigen LS2 (LSA1 ad LSAP2) fused to the C-terminal end of the leader sequence of tPA.
15957896|NCT03203408|Device|OSTENIL PLUS|Injection into the joint cavity of the most painful knee
15957897|NCT03203408|Device|SYNVISC-ONE|Injection into the joint cavity of the most painful knee
15957898|NCT03203395|Behavioral|Screening and counselling|Screening for symptoms of depression and anxiety in heart patients, giving advice for prevention and managing of such symptoms and stimulating collaborative care between the hospital and the general practitioner.
15957899|NCT03203369|Biological|UCART123|Allogeneic engineered T-cells expressing anti-CD123 Chimeric Antigen Receptor given as a single dose following a lymphodepleting regimen.
15957900|NCT03203356|Drug|growth hormone|Children with a diagnosis of GHD will practice GH replacement therapy in line with normal clinical practice and international guidelines. Controls will be evaluated just at baseline.
15957901|NCT03203343|Procedure|Operation - PIRS|Operation by its known design for PIRS group
15957902|NCT03203343|Procedure|Operation - MARCY|Operation by its known design for MARCY group
15957903|NCT03203330|Biological|TG-C|2 mL injection of non-transduced human chondrocytes and irradiated transduced human GP2-293 cells expressing TGF-B1.
15957904|NCT03203330|Biological|Placebo Control|2 mL normal saline injection
15957905|NCT03203317|Drug|Insulin|2 h insulin clamp
15957906|NCT03203317|Other|Exercise|Cycling exercise
15957907|NCT03203304|Drug|Nivolumab|240mg every two weeks by IV infusion
15957908|NCT03203304|Drug|Ipilimumab|1mg/kg every six weeks by IV infusion
15957909|NCT03203291|Device|TPAD (Tethered Pelvic Assist Device)|Each day of intervention will include a 1-hour treadmill based intervention to promote increased loading onto the affected limb. Visual feedback will be provided and faded over the course of the 5-day training. Immediately on completion of the treadmill intervention, participants will receive an additional 5-10 minutes of overground intervention reinforcing weight shifting onto the affected limb.
15957910|NCT03203278|Behavioral|Web-based exercise programme|Aerobic, resistance and balance exercises
15957911|NCT03203265|Other|Group A: Offline HTC|Offline or online referral to HIV treatment facility HIV-positive participants can choose to receive either an offline or online referral to HIV treatment facilities. An offline referral method usually includes a referral letter and/or a telephone call, followed by a series of calls to participants to ensure successful referral. Those who choose an online referral will be able to register online with an HIV treatment facility which provides ART without cost under the national programs. Participants will receive a registration code which will allow them to access HIV treatment clinics directly without the need to go through the regular registration and appointment system at that facility.
15957912|NCT03203265|Other|Group B1: Offline HIV testing and post-test counseling|participants will be guided to access services at the 'Adam's Love Offline Clinic,' a clinic set up specifically to provide private and fast HIV testing and post-test counseling only referred from the Adam's Love Online Clinic.
15957913|NCT03203265|Other|Group B2: Online HIV testing and post-test counseling|A trained online counselor will guide the participant through an online HIV testing process which includes quality checking of the test kit,obtaining blood through finger prick,performing the testing steps,reading the test result. A positive result from the first test will trigger the need for referral to confirmatory tests. The provisional nature of the positive result from the single rapid HIV test will be emphasized but the urgency to get immediate confirmatory tests and linkage to HIV treatment facilities will encouraged and supported. HIV positive test result will be confirmed only with three positive tests. Any online testing session with uncertain qualities at any step will be repeated at a later time or the participant will be offered offline HIV testing.
15957914|NCT03203252|Other|Reconstruction BREAST-Q|Validated Patient reported outcome measure specifically designed to assess Quality of life domains and satisfaction following breast reconstruction.
15957915|NCT03203252|Other|3-dimensional Surface Image|Non-invasive 3-dimensional photograph using VECTRA® XT 3D imaging system.
15957916|NCT03203252|Other|Treatment Questionnaire|Online questionnaire pertaining to treatment received pertaining to breast cancer or risk reduction for breast cancer.
15957917|NCT03203239|Device|Red Light (670 nm energy)|Light Emitting Diode light source (670 nm wavelength with output up to 75mW/cm2) will be placed over the gastrocnemius muscle. The light will be on for 5 minutes.
15957918|NCT03203239|Drug|Octafluoropropane|All subjects will undergo infusion of octafluoropropane to measure peripheral blood flow.
15957919|NCT03203226|Other|FELDENKRAIS METHOD (FM)|They EG will receive the intervention of FM consisting of 30 lessons (1h-lesson per week; 30 weeks) verbal instructions provided by the therapist to participants. These instructions provide different options on how to perform a specific task with the purpose of leaving the decision on how to do the movement up to the performer, who has to focus on thinking, feeling, sensing and doing the movement as easily as possible.The lessons can be conducted sitting, standing or moving within a room.
15957920|NCT03203213|Procedure|Sampling of a few drops of blood, lock of hair and urine|Sampling of a few additional drops of blood to deposit them on blotting paper (DBS: Dried Blood Spot) ad hoc and to send this sample for analysis and identification of a possible toxic cause by psychoactive substance in relation to the clinical picture presented by the patient. An oriented capillary sampling is also performed if possible. Similarly a urine sample is taken if possible.
15957921|NCT03203200|Behavioral|ZETRA cognitive behavioral structural|ZETRA cognitive behavioral structural
15957922|NCT03203187|Other|Mango|330 grams (2 cups) of daily mango intake for two weeks, one cup in the morning, the other in the evening
15957923|NCT03203187|Other|No intervention|No mango intake for two weeks.
15957924|NCT03203174|Device|Microneedle|Microneedles are small needles used to create holes in the stratum corneum (top layer of skin) with relatively low amount of pain.
15957925|NCT03203174|Device|Sham Microneedle|Flat roller with no needles on the roller
15957926|NCT03203174|Drug|Botulinum Toxin Type A|Botulinum toxin type A will be applied to the palm
15957927|NCT03203174|Other|Saline|Saline applied to the palm
15957928|NCT03203161|Procedure|bariatric surgery|Roux-and-Y Gastric Bypass or Sleeve gastrectomy
15957930|NCT03203135|Behavioral|Nutritional prevention programme|The nutritional prevention programme will offer a wide range of food and physical activity activities adapted to the life of the company (example: culinary demonstration, physical activity, provision of fruit baskets, etc.) .
15957931|NCT03203122|Other|IPL laser|IPL laser monthly. Vertical and horizontal treatment, one pass over. Settings according to fitzpatrick skin type
15957932|NCT03203122|Other|No sham treatment|The treatment is slightly painful, and noisy. Sham treatment impossible
15957933|NCT03203109|Behavioral|Postural Assessment Scale for Stroke (PASS)|Postural Assessment Scale for Stroke (PASS)
15957934|NCT03203096|Dietary Supplement|Magnesium|Magnesium citrate / Magnesium oxide
15957935|NCT03203096|Dietary Supplement|Placebo|
15957936|NCT03203083|Other|performance of the single leg squat task|The single-leg squat (SLS) is a clinical functional test commonly used to evaluate clinical abnormal movement patterns of the lower limbs in terms of kinetic chain or co-ordinating muscle activity. This scale accounts for the assessment of five dimensions: overall impression, trunk posture, pelvis in space, hip joint motion and knee join motion. The SLS is potentially promising as a functional test since it involves both daily activity and athletic task.
15957937|NCT03203070|Drug|Metamizol iv|Postoperative analgesia iv with Metamizol 2g/8h will be administered.
15957938|NCT03203070|Procedure|TAP block|Intraoperative laparoscopic-guided TAP block will be performed with 30ml Bupivacaine 0.5%
15957939|NCT03203057|Other|coronary occlusion|percutaneous coronary intervention
15957940|NCT03203044|Other|Soylent and water diet|A diet of five servings of Soylent 2.0 liquid meal-replacement drink per day and water as needed.
15957941|NCT03203031|Procedure|General anesthesia|Standard general anesthesia
15957942|NCT03203031|Procedure|Quadratus lumborum block|Guided by ultrasonography, injection of 0.5 ml/kg of ropivacaine (2 mg/ml) between the quadratus lumborum muscle and the internal oblique muscle, before skin incision
15957943|NCT03203018|Behavioral|Interactive workshop based on community specific needs|"Intervention components will include lecture on women's CVD, workshop on how to prepare for a doctor's visit, patient's rights and patient-doctor communication skills, and a know your numbers workshop, including understanding blood test results."
15957944|NCT03203005|Drug|IMA970A plus CV8102 and Cyclophosphamide|"Study treatment starts with a single intravenous infusion of 300mg/m2 Cyclophosphamide.
~Three days later patients start vaccination therapy with IMA970A plus CV8102 Each vaccination consists of a dose of 6.80 milligrams (mg) IMA970A (containing approx. 400 micrograms [µg] of each individual peptide) followed by a dose of 50 µg CV8102. First IMA970A is injected intradermally (i.d.) and about 10 minutes later CV8102 is injected i.d. at the same vaccination site in close proximity. Patients will receive 4 vaccinations at weekly intervals followed by 5 vaccinations at 3-weekly intervals for a total duration of about 4.5 months."
15957945|NCT03202992|Drug|ABI-1968|Topical cream applied at Day 1 for the SAD portion and applied at Day 1, Day 8, Day 15, Day 22 and Day 29 for the MAD portion
15957946|NCT03202979|Drug|Trazodone 20 mg|"Oral administration of trazodone 20 mg (corresponding to 10 drops of trazodone hydrochloride 6% oral solution), three times a day, for 8 weeks. Trazodone total daily dose: 60 mg.
~After the 8-week treatment period, patients will receive trazodone 10 mg (corresponding to 5 drops of trazodone hydrochloride 6% oral solution) three times a day for 1-week tapering period in double blind conditions."
15957947|NCT03202979|Drug|Trazodone 10 mg|"Oral administration of trazodone 10 mg (corresponding to 5 drops of trazodone hydrochloride 6% oral solution), three times a day, for 8 weeks. Trazodone total daily dose: 30 mg.
~In order to maintain the study double-blind conditions,patients randomized in this group will be co-administered with placebo oral solution (5 drops).
~After the 8-week treatment period, patients will receive placebo oral solution three times a day for 1-week tapering period in double blind conditions."
15957948|NCT03202979|Drug|Placebo|"Oral administration of placebo oral solution (10 drops) three times a day, for 8-week treatment.
~After the 8-week treatment period, patients will receive placebo oral solution three times a day for 1-week tapering period in double blind conditions."
15957949|NCT03202966|Other|Rehabilitation therapy|Rehabilitation therapy will be provided by a trained community rehabilitation worker (CRW) and specialist (i.e., physical therapist, occupational therapist, special educator and/or speech therapist) with a focus on the one or more domains where delays are identified (i.e. speech, motor, cognition). Therapy will be tailored based on the needs of the individual child and will follow current evidence-based practice.
15957950|NCT03202953|Procedure|ventilation strategy 1|"In Group I, after trendelenburg position, patients will be applied 1:1 ratio VCV.
~Tidal volume : 8ml/kg, inspiration:expiration ratio = 1:1, FiO2 = 0.5, maintain end tidal CO2 around 40±5 mmHg. Positive end expiratory pressure will not used."
15957951|NCT03202953|Procedure|ventilation strategy 2|"In group A, after trendelenburg position, patients will be applied autoflow VCV.
~- Tidal volume : 8ml/kg, inspiration:expiration ratio = 1:2, FiO2 = 0.5, maintain end tidal CO2 around 40±5 mmHg. Positive end expiratory pressure will not used."
15957952|NCT03202940|Drug|Alectinib|Alectinib is an oral ALK inhibitor. The term ALK inhibitor means that alectinib targets the abnormal ALK protein that is causing lung cancer cells to grow
15957953|NCT03202940|Drug|Cobimetinib|Cobimetinib is an oral inhibitor of MEK, a signaling protein that can cause some types of lung cancer to grow
15957954|NCT03202927|Drug|PEGFILGRASTIM|Pegfilgrastim is a covalent conjugate of recombinant methionyl human granulocyte colony-stimulating factor and monomethoxy polyethylene glycol.
15957955|NCT03202914|Behavioral|Usual protein and phosphorus diet|Diet intervention
15957956|NCT03202914|Behavioral|Low protein and phosphorus diet|Diet intervention
15957957|NCT03202914|Behavioral|Very low protein and phosphorus|Diet intervention
15957958|NCT03202901|Dietary Supplement|B-turmactive|"The treatment consists of daily administration of B-TURMACTIVE®.
~Treatment with B-TURMACTIVE® will last 7 days to determine the effects of the product in the short term, during which the volunteers will be visited 4 times:
~V0 screening: to evaluate the inclusion and exclusion criteria. V1 inclusion and randomisation (Day 1): 1st day treatment and intervention. Measure primary and secondary variables V2 (Day 3): the primary endpoint will be monitored by telephone (perception of pain).
~V3 (Day 7): Day 7 of treatment and final intervention. Measure primary and secondary variable"
15957994|NCT03202654|Other|Corn Oil|4 tablespoons/day of corn oil for 4-week treatment period.
15957995|NCT03202654|Other|Coconut Oil|4 tablespoons/day of coconut oil for 4-week treatment period.
15957959|NCT03202901|Dietary Supplement|Placebo|"The treatment consists of daily administration of placebo capsule with identical format and harmless thant B-turmactive product.
~Treatment with placebo will last 7 days to determine the effects of the product in the short term, during which the volunteers will be visited 4 times:
~V0 screening: to evaluate the inclusion and exclusion criteria. V1 inclusion and randomisation (Day 1): 1st day treatment and intervention. Measure primary and secondary variables V2 (Day 3): the primary endpoint will be monitored by telephone (perception of pain).
~V3 (Day 7): Day 7 of treatment and final intervention. Measure primary and secondary variable"
15957960|NCT03202888|Behavioral|Intervention|QuesGen-created mobile responsive website tool, Family Input for Quality and Safety.
15957961|NCT03202875|Drug|SAR341402|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
15957962|NCT03202875|Drug|Insulin Aspart|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
15957963|NCT03202875|Drug|Insulin Aspart|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
15957964|NCT03202862|Drug|Fulvestrant|Fulvestrant 500 mg given as two 5 ml intramuscular inections, one in each buttoc, on days 1, 15, 2 and every 2 ( ) days thereafter.
15957965|NCT03202849|Dietary Supplement|Vitamin D and A|A single dose of Vitamin A and Vitamin D will be given.
15957966|NCT03202849|Dietary Supplement|Vitamin D and Placebo|A single dose of Vitamin D plus a placebo will be given.
15957967|NCT03202836|Drug|progesterone|vaginal utrogestan
15957968|NCT03202836|Drug|Tocolytics|tocolysis for 48 hours
15957969|NCT03202836|Drug|Steroids|antenatal corticosteroids for 48 hours
15957970|NCT03202823|Procedure|blood samples|3 tubes (5 ml volume) collected during surgery
15957971|NCT03202823|Procedure|recover samples of atheromatous plaque|a carotid sample collected during surgery
15957972|NCT03202797|Other|audiometric tests|tone and speech audiometry
15957973|NCT03202797|Other|Questionnaires|APHAB (Abbreviate Profile of Hearing Aid Benefit), HISQUI (Hearing Implant Sound Quality Index), Munich music questionnaire
15957974|NCT03202797|Other|Settings of cochlear implants|pitch matching, evolutionary algorithm setting
15957975|NCT03202784|Drug|BCX7353|BCX7353
15957976|NCT03202771|Device|Home Biofeedback Therapy|Patients will be taught how to use the home-trainer in a single lab session. Then we will place a reusable, dual sensor, probe into their rectum. The probe is connected to a hand- held pressure monitor displaying the patient's response. Next, the clothed patient will be asked to sit on a commode, and attempt 15 bearing down maneuvers. When the anal sphincter pressure decreases more lights go on. If the patient cannot relax then fewer lights go on. Thus, the number of lighted lights gives instant feedback about their performance. Patients will get a 20-minute tape recording for home use. Patients will be asked to insert the probe at least twice daily and each time practice at least 15 bearing down maneuvers; a daily log will be kept. At 4 and 8 weeks, they will return for follow up. Based on their progress, new targets will be set by adjusting the device's sensitivity.
15957977|NCT03202771|Other|Office Biofeedback Therapy|A monitor screen will provide visual feedback by showing changes in pressure activity. First patients will be taught abdominal muscle coordination exercise to improve the pushing effort during defecation. Here, patients are taught how to distend the abdomen by inhaling slowly and then holding their breath for at least 15 seconds and to practice this for 20 minutes, twice a day. Thereafter, patients will be asked to attend the motility laboratory, biweekly for up to 6 training sessions. Biofeedback Therapy (BT) will be performed by a 3-sensor manometry probe. The clothed patient will be seated on a commode in front of a monitor. The physician/nurse therapist will give verbal feedback by either complimenting the patient for performing a correct maneuver or rectifying any errors. Each 60 minute treatment session will comprise of the following maneuvers:
15957978|NCT03202758|Drug|Durvalumab, Tremelimumab and ,FOLFOX|"Study will be performed in 2 step:
~STEP 1 (phase Ib) will assess the safety of the combination of Durvalumab 750mg q2w + tremelimumab 75mg q4w + FOLFOX during the 2 first cycles of treatment (1 month)
~STEP 2 (phase II) will assess the efficacy of the combination of Durvalumab 750mg q2w + tremelimumab 75mg q4w + FOLFOX"
15957979|NCT03202745|Other|Patient Consequences Letter|This letter focuses on the consequences of inappropriate prescribing for patients. It also includes a peer comparison.
15957980|NCT03202745|Other|Prescriber Consequences Letter|This letter focuses on the consequences of inappropriate prescribing for prescribers. It also includes a peer comparison.
15957981|NCT03202732|Other|DiabetesFlex|"DiabetesFlex consist of one mandatory and two optional consultations. Before the consultations patients receive the AmbuFlex Diabetes questionnaire.
~The AmbuFlex Diabetes questionnaire is based on both validated questionnaires and clinical consensus. The AmbuFlex Diabetes questionnaire consists of: SF36 well-being question, WHO-5 Well-being Index. Questions concerning: HgA1c, home-based blood pressure monitoring, incidents of hypoglycemia, diabetes complications, regular eye check, regular food check, erectile dysfunction and peripheral neuropathy, The PAID scale, Topics patients may want to talk with the health care professional about, the patient's evaluation of the need for diabetes care. View the AmbuFlex Diabetes questionnaire at the homepage: www.diabetesflex.auh.dk."
15957982|NCT03202719|Biological|Bivalent oral poliovirus vaccine (bOPV) at 6,10 and 14 weeks of age|bOPV at 6, 10 and 14 weeks of age
15957983|NCT03202719|Biological|Inactivated poliovirus vaccine (IPV) at 14 weeks and 18 months of age|IPV at 14 weeks and 18 months of age
15957984|NCT03202719|Biological|Inactivated poliovirus vaccine (IPV) at 14 weeks, 18 weeks and 18 months of age|IPV at 14 weeks, 18 weeks and 18 months of age
15957985|NCT03202719|Biological|Inactivated poliovirus vaccine (IPV) at 14 weeks and 9 months of age|IPV at 14 weeks and 9 months of age
15957986|NCT03202719|Biological|Inactivated poliovirus vaccine (IPV) at 6 weeks and 9 months of age|IPV at 6 weeks and 9 months of age
15957987|NCT03202719|Biological|Inactivated poliovirus vaccine (IPV) at 6 and 14 weeks of age|IPV at 6 and 14 weeks of age
15957988|NCT03202706|Procedure|Samples of adipose tissue|Samples of visceral and subcutaneous adipose tissue collected during hernia surgery
15957989|NCT03202693|Drug|PA-824|
15957990|NCT03202680|Other|USDA Style Diet|USDA style healthy diet, low in saturated fats.
15957991|NCT03202680|Other|Lean Beef Diet|A lean beef containing healthy diet, low in saturated fats.
15957992|NCT03202667|Drug|Empagliflozin 25mg|Treatment with empagliflozin 25mg once daily for 28 days
15957993|NCT03202667|Drug|Placebo|Treatment with Placebo oral tablet once daily for 28 days
15957997|NCT03202641|Procedure|PEEP LRM|A lung recruitment maneuver (LRM) followed by PEEP guided by transpulmonary pressure.
15957998|NCT03202628|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo ASCT
15957999|NCT03202628|Drug|Dexamethasone|Given PO
15958000|NCT03202628|Drug|Ixazomib Citrate|Given PO
15958001|NCT03202628|Other|Laboratory Biomarker Analysis|Correlative studies
15958002|NCT03202628|Drug|Pomalidomide|Given PO
15958003|NCT03202615|Dietary Supplement|L (lactoferrin)|Dietary Supplement: Pravotin sachets (Hygint, Egypt) containing bLf One sachet of Pravotin contains 100 mg of bLf. Dosage: one sachet twice a day before meals with placebo tablets
15958004|NCT03202615|Drug|F (ferrous sulphate)|Drug: FerroGrad by Abbott Dosage: one capsule three times /day containing150 mg of dried ferrous sulfate capsules (Ferrofol capsules, Eipico, Egypt), with placebo sachets.
15958005|NCT03202602|Other|Telemonitoring of CPAP treatment|Telemedicine technology allows for monitoring of CPAP pressure, air leaks, apnea-hypopnea index (AHI) and compliance on a daily basis.
15958006|NCT03202602|Other|Standard care|Office visits and monitoring of CPAP treatment at each visit.
15958007|NCT03202589|Other|FOCUS Echocardiography|FOCUS Echocardiography
15958008|NCT03202576|Device|Nasal Bridle|Nasal bridle placement and securement of the tube. Instead of taping the tube to the patient's face, nose or upper lip the bridle is a device whereby a magnetic retrieval system is attached to 1/8 inch umbilical tape which is inserted via the nares, looping around the nasal septum and vomer bone and ending with both ends of the bridle (umbilical tape) secured together and to the feeding tube just outside the nose.
15958009|NCT03202563|Drug|Gemigliptin 50mg|For patients who have been randomized to Gemigliptin(Experimental arm), the patients continue to take a gemigliptin 50mg 1 tablet by once daily during study treatment period(Visit 3(day 1)~Visit 6(day 91))
15958010|NCT03202563|Drug|Dapagliflozin 10mg|For patients who have been randomized to Dapagliflozin(Active Comparator arm), the patients continue to take a dapagliflozin 10mg 1 tablet by once daily during study treatment period(Visit 3(day 1)~Visit 6(day 91))
15958011|NCT03202563|Procedure|Diet/exercise questionnaire|"doing exercise with about intermediate intensity(50~70%) for ≥150minutes in total over at least 3 times(every other day) weekly should be recommended and regular diet without greater changes in life style as much as possible during the whole study period.
~the questionnaire regarding diet/exercise will be collected at -day 6, day 1, day29, day85, day 91"
15958012|NCT03202563|Device|Continuous Glucose Monitoring System(CGMS)|For patients who have been screening completely, the subjects will be attached CGMS(ipro-2) twice from Visit 2(-day 6) to Visit 3(day 1) and Visit 5(day 85) to Visit 6(day 91)
15958013|NCT03202563|Drug|Metformin|For patients who have been taking metformin, the patients who had taken at least 1000 mg of metformin daily and continue the same dosage and administration as before participant in the study
15958014|NCT03202550|Drug|Oxycodone and Lorazepam (Active Comparator)|Oxycodone and Lorazepam
15958015|NCT03202550|Drug|Placebo Comparator|Placebo oral pills
15958016|NCT03202537|Drug|dexlansoprazole|dexlansoprazole treatment for Gastroesophageal Reflux symptoms
15958017|NCT03202524|Biological|Fresh Frozen Plasma (FFP)|FFP will be used as a substitute for albumin for the prevention of post-paracentesis circulatory dysfunction.
15958018|NCT03202524|Biological|Albumin|Albumin will be used for the prevention of post-paracentesis circulatory dysfunction, as is the standard of care
15958019|NCT03202511|Drug|Probenecid Oral Tablet|Included in arm/group descriptions.
15958020|NCT03202511|Drug|Tenofovir disoproxil fumarate/Emtricitabine|Included in arm/group descriptions.
15958021|NCT03202498|Device|4g Yaq-001|Study patients will be dosed daily with 4g of product Yaq-001 for a period of 12 weeks. The product will be provided as beads packed in individual sachets intended each for one oral administration. For each patient, the study duration will be up to 17 weeks, including the screening (up to 4 weeks), treatment (12 weeks) and 7-day follow up period.
15958022|NCT03202498|Other|4g Placebo|Study patients will be dosed daily with a quantity of placebo equivalent to 4g of product Yaq-001 for a period of 12 weeks. The product will be provided as beads packed in individual sachets intended each for one oral administration. For each patient, the study duration will be up to 17 weeks, including the screening (up to 4 weeks), treatment (12 weeks) and 7-day follow up period.
15958023|NCT03202498|Device|8g Yaq-001|Study patients will be dosed daily with 8g of product Yaq-001 for a period of 12 weeks. The product will be provided as beads packed in individual sachets intended each for one oral administration. For each patient, the study duration will be up to 17 weeks, including the screening (up to 4 weeks), treatment (12 weeks) and 7-day follow up period.
15958024|NCT03202498|Other|8g Placebo|Study patients will be dosed daily with a quantity of placebo equivalent to 8g of product Yaq-001 for a period of 12 weeks. The product will be provided as beads packed in individual sachets intended each for one oral administration. For each patient, the study duration will be up to 17 weeks, including the screening (up to 4 weeks), treatment (12 weeks) and 7-day follow up period.
15958025|NCT03202485|Device|Toric Implantable Collamer Lens|uses Toric Implantable Collamer Lens implantation to correct the high myopic astigmatism.
15958026|NCT03202485|Device|ICL + Astigmatic keratotomy|uses Implantable Collamer Lens implantation combined with Astigmatic keratotomy to correct the high myopic astigmatism
15958027|NCT03202472|Device|Implanted Medical Device|Radiofrequency tag
15958028|NCT03202472|Procedure|Mammography|Undergo mammogram for image-guided placement of radiofrequency tag
15958029|NCT03202472|Other|Questionnaire Administration|Ancillary studies
15958030|NCT03202472|Procedure|Radiofrequency (RFID) -Guided Localization|Undergo radiofrequency-guided localization
15958031|NCT03202472|Procedure|Ultrasonography|Undergo ultrasound for image-guided placement of radiofrequency tag
15958032|NCT03202459|Drug|Group A - gabapentin 600 mg|The patient will receive oral 600 mg gabapentin 2 h before surgery
15958033|NCT03202459|Drug|Group B - pregabalin|The patient will receive oral pregabalin 150 mg 2 h before surgery
15958034|NCT03202459|Drug|Group C - placebo|The patient will receive oral placebo 2 h before surgery and ondansetron 8mg intravenous at the end of the surgery
15958035|NCT03202446|Drug|1% Glycated Chitosan|
15958036|NCT03202446|Device|Photothermal Laser|
15958037|NCT03202446|Drug|Placebo|
15958038|NCT03202446|Drug|Cyclophosphamide|
15958040|NCT03202433|Device|Use of virtual reality lenses, with relaxing audio-visual contents|Use of virtual reality lenses (and audio) as a distraction for the blood donor patients.
15958041|NCT03202420|Other|TOPS|Take Off Pounds Sensibly (TOPS) is a national, nonprofit, peer-led, group-based, weight loss program that offers a comprehensive program on diet and physical activity with group support for weight management.
15958042|NCT03202407|Drug|Calcium acetate and sevelamer hydrochloride|receive the conventional renal replacement therapy including calcium-based phosphate (calcium acetate) and active form of vitamin D for 3 months with regular follow up of serum phosphate ,calcium, parathyroid hormone and alkaline phosphate every month
15958043|NCT03202394|Drug|BIO-11006|"Intervention involves aerosolized delivery of either the active drug or placebo by the Aeroneb Pro nebulizer."
15958044|NCT03202394|Drug|Placebo|"Intervention involves aerosolized delivery of either the active drug or placebo by the Aeroneb Pro nebulizer."
15958045|NCT03202381|Drug|Degarelix|"Degarelix (Firmagon®) will be administered as a subcutaneous injection in the abdominal region every 28 days, in according to the following schedule:
~Starting dose: 240 mg administered as two consecutive subcutaneous injections of 120 mg each (2 x 3 mL injections).
~Maintenance dose: 80 mg administered as one subcutaneous injection of 80 mg (1 x 4 mL injection).
~Treatment will be continued till clinically indicated or till disease progression."
15958046|NCT03202368|Drug|Tocilizumab|162 milligrams (mg) of tocilizumab every week for a maximum of 156 weeks or until the commercial availability of tocilizumab, whichever comes first
15958047|NCT03202355|Device|Fixed Appliance Orthodontic Treatment|Patients receive fixed appliance orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.
15958048|NCT03202355|Device|OrthoPulse™|Patients carry out daily OrthoPulse™ treatments at home.
15958049|NCT03202342|Other|Water|Water, 300 ml, at room temperature
15958050|NCT03202342|Other|Glucose|Water containing 50 g glucose, 300 ml, at room temperature
15958051|NCT03202342|Other|Ethyl butyrate|Water containing ethyl butyrate (pineapple flavour) 300 ml, at room temperature
15958052|NCT03202342|Other|Glucose + ethyl butyrate|Water containing 50 g glucose and ethyl butyrate (pineapple flavour) 300 ml, at room temperature
15958053|NCT03202342|Other|Glucose + ethyl butyrate 0 C|Water containing 50 g glucose and ethyl butyrate (pineapple flavour) 300 ml, at 0 degrees centigrade
15958054|NCT03202329|Other|standard care|cardiologists assist in treatment and provide heart failure guidance post-operatively if required by the treating surgeon
15958055|NCT03202329|Other|Nurse-based care|board-certified heart failure nurses provide heart failure guidance post-operatively on every working day
15958056|NCT03202316|Drug|Atezolizumab|Given IV
15958057|NCT03202316|Drug|Cobimetinib|Given PO
15958058|NCT03202316|Drug|Eribulin|Given IV
15958059|NCT03202316|Other|Laboratory Biomarker Analysis|Correlative studies
15958060|NCT03202316|Other|Pharmacological Study|Correlative studies
15958061|NCT03202303|Drug|Cannabidivarin|Weight-based dosing of 10 mg/kg/day of CBDV
15958062|NCT03202303|Drug|Matched Placebo|Weight-based dosing of 10 mg/kg/day of placebo
15958063|NCT03202290|Behavioral|Cognitive and clinical assessment|The content of the assessment will be the same for all subjects and will consist of a cognitive assessment (neurocognition, social cognition, metacognition, emotional reactivity) and a clinical assessment (impulsivity, personality, psychriatric and addictive comorbidities)
15958064|NCT03202277|Behavioral|BeWell24 smartphone app|This app delivers an evidence-based suite of lifestyle interventions targeting behavior change in sleep, sedentary behavior, physical activity, and dietary intake. The app connects with a commercially available activity monitor to provide real-time feedback on behaviors over time.
15958065|NCT03202277|Behavioral|Health education app|This app delivers basic health education and hygiene content related to sleep, sedentary behavior, physical activity, and dietary intake.
15958066|NCT03202264|Other|TAPER|"The intervention is medication reduction. This arm is comprised of:
~Medication reconciliation
~Identification of patient priorities for care
~Identification of medications that are potentially appropriate for discontinuation/dose reduction
~Linked pharmacist/family physician consultations with patient to discuss medication with intention to reduce
~Identification of medications for trial of discontinuation/dose reduction (shared decision making)
~Pause of medication and clinical monitoring"
15958067|NCT03202251|Other|It's is a cohort|It is a prospective, observational, cohort study
15958068|NCT03202238|Other|Conventional|Conventional venepuncture without use of any venepuncture assistive device.
15958069|NCT03202238|Device|Veinlite|Commercial transilluminator device that allows veins to show up as a silhouette among surrounding soft tissue
15958070|NCT03202238|Device|TenTaTorch|Transilluminator device that allows veins to show up as a silhouette among surrounding soft tissue
15958071|NCT03202225|Device|constrained polyethylene|constrained polyethylene insert
15958072|NCT03202212|Procedure|mixed on-line hemodiafiltration|This is a mixed hemodepurative technique exploiting diffusion and convection through a semi-permeable membrane. Dialysis solution is not only interfacing with blood through the membrane (as in bicarbonate hemodialysis) but it is also mixed with it with a pre- and a post- filter dilution. The same amount of fluid added to the bloodstream is then removed within the filter through an appropriate negative pressure in the dialysis solution compartment and thanks a high permeability membrane. Patients will be treated three sessions per week, four hours per session
15958073|NCT03202212|Procedure|High flux bicarbonate dialysis|Standard high flux bicarbonate dialysis with polysulfone membrane, three sessions per week, four hours per session
15958074|NCT03202199|Device|PET/MRI|2 PET/MRI examinations
15958075|NCT03202186|Drug|Progesterone oral capsule|Oral capsule treatment
15958076|NCT03202186|Drug|Placebo oral capsule|Oral capsule treatment
15958077|NCT03202173|Diagnostic Test|10% fluorescein|The nasopharyngeal lesions were first identified endoscopically by nasal endoscope. Then, an initial dose of 0.5 mL prior to the examination with a maximum dose of 2.5 mL of 10% fluorescein (IV; Akorn Inc, Lake Forest, Illinois, USA) during the measurement procedure was defined according to the experiences of workgroup in the gastrointestinal tract.
15958078|NCT03202147|Drug|Cromolyn|Active capsules for inhalation.
15958079|NCT03202147|Other|Placebo|Non-active capsules for inhalation.
15958080|NCT03202134|Other|opioid free anesthesia|general anesthesia blocking reflexes without using an opioid
15958081|NCT03202121|Other|insomnia group|After screening according to inclusion and exclusion criteria, patients were assigned to insomnia group that contained 25 cases.
15958082|NCT03202121|Other|non-insomnia group|After screening according to inclusion and exclusion criteria, patients were assigned to non-insomnia group that contained 25 cases.
15958083|NCT03202121|Other|normal control|Persons without stroke or insomnia served as normal controls that contained 25 cases.
15958084|NCT03202108|Dietary Supplement|Krio|"Krio is a ready to eat, chocolate-flavoured, solid bar containing 20g fat per 28g bar. It contains protein and carbohydrate with added sweetener and flavourings. It does not contain any added micronutrients. Krio is not for use as a sole source of nutrition.
~It has a fat to protein and carbohydrate ratio of 3 to 1, making it suitable for use in all versions of the ketogenic diet.
~This product is to be consumed daily under the direction of a dietitian."
15958085|NCT03202095|Drug|Creatine Monohydrate|5 grams daily of oral creatine monohydrate powder.
15958086|NCT03202082|Behavioral|Neuropsychological testing|Neuropsychological testing evaluates various aspects of a participants cognitive ability as well as mood.
15958087|NCT03202069|Other|Even protein|Intake of even protein 5 day rotating menu
15958088|NCT03202069|Other|Skewed protein|Intake of skewed protein 5 day rotating menu
15958089|NCT03202056|Other|Dry needling|Dry needling is a skilled intervention that uses a thin filiform needle to penetrate the skin and stimulate underlying myofascial trigger points, muscular, and connective tissues for the management of neuromusculoskeletal pain and movement impairments.
15958090|NCT03202056|Other|Sham Dry needling|Sham Dry needling use a non-penetrating acupuncture needle
15958091|NCT03202043|Other|High dose vegetable juice|High dose (13 fl oz) vegetable juice
15958092|NCT03202043|Other|Medium dose vegetable juice|Medium dose (10 fl oz) vegetable juice
15958093|NCT03202043|Other|Low dose vegetable juice|Low dose (5.5 fl oz) vegetable juice
15958094|NCT03202043|Other|Control bottled water|Control (12 fl oz) bottled water
15958095|NCT03202030|Procedure|Immediate dentoalveolar restoration|Block of bone removed from the tuber and placed in the buccal resorption of the socket together with an immediate implant
15958096|NCT03202030|Procedure|Demineralized bovine bone|Block of demineralised bovine bone placed in the buccal resorption of the socket together with an immediate implant
15958097|NCT03202017|Procedure|Expiratory Muscle Strength Training (EMST)|EMST uses a training device that has a valve set to 50% of a patient's maximum expiratory pressure (MEP). The patient exhales forcefully until the valve releases. Patients perform 5 sets of 5 repetitions a day, 5 days a week.
15958098|NCT03202017|Procedure|EMST + Lung Volume Recruitment (LVR)|"EMST uses a training device that has a valve set to 50% of a patient's maximum expiratory pressure (MEP). The patient exhales forcefully until the valve releases. Patients perform 5 sets of 5 repetitions a day, 5 days a week.
~LVR is a technique to increase cough function that is performed with a resuscitation bag fitted with a mouthpiece and a one-way valve. The bag is used to expand the lungs, after which the patient makes a voluntary cough. Half of the participants will perform the LVR technique in addition to the ESMT technique."
15958099|NCT03202004|Drug|GSK2894512 1% cream|1 % (10 mg/g) GSK2894512 cream will be provided in tubes labeled in compliance with country requirements.
15958100|NCT03202004|Drug|Vehicle cream|Vehicle cream will be provided in tubes labeled in compliance with country requirements.
15958101|NCT03201991|Other|Resistance Exercise Program|The resistance exercise program will involve three sets of 10 repetitions of each exercise in levels 1 and 2 every day. Participants will be given instructions to follow.
15958102|NCT03201978|Drug|GSK2894512 1% CREAM|It will be prepared as close as possible to the time of administration to avoid a prolonged exposure to light. Each single cream application will be made by weight, dispensed on hand (fingertips) covered with clean disposable glove and evenly spread using fingertips.
15958103|NCT03201978|Drug|GSK2894512 MATCHING VEHICLE CREAM|It will be prepared as close as possible to the time of administration to avoid a prolonged exposure to light. Each single cream application will be made by weight, dispensed on hand (fingertips) covered with clean disposable glove and evenly spread using fingertips.
15958104|NCT03201965|Drug|Cyclophosphamide|Participants will receive 300 mg/m^2 of cyclophosphamide as an oral or IV dose.
15958105|NCT03201965|Drug|Bortezomib|Participants will receive 1.3 mg/m^2 of bortezomib as an subcutaneous (SC) injection.
15958106|NCT03201965|Drug|Dexamethasone, 40 mg|Participants of CyBorD alone arm will receive 40 mg dexamethasone orally or IV dose. Participants of CyBorD plus daratumumab arm will receive dexamethasone 20 mg orally or IV dose as premedication and 20 mg on the day after daratumumab dosing to make a total of 40 mg.
15958107|NCT03201965|Drug|Daratumumab|Participants will receive 1800 mg of daratumumab subcutaneously.
15958108|NCT03201952|Drug|Ursodeoxycholic Acid|Ileostomy administration of 300mg UDCA once
15958109|NCT03201952|Drug|Placebos|Ileostomy administration of 5cc saline placebo once
15958110|NCT03201939|Drug|Lisinopril|ACE-inhibitor (lisinopril)(intervention arm
15958111|NCT03201939|Other|Placebo Oral Tablet|Comparator placebo (control arm)
15958112|NCT03201926|Dietary Supplement|mealworms|10g , 3 times a day , po, 2 months
15958113|NCT03201926|Dietary Supplement|grain powder|grain powder, 10g ,3times one day,2months
15958114|NCT03201913|Drug|TTC-352|Phase 1 study to determine the maximum tolerated dose (MTD) of TTC-352.
15958115|NCT03201900|Drug|E2007|Oral tablet
15958116|NCT03201887|Behavioral|Sub-optimal effort|Participants will be asked to play a patient who wishes to present himself as having cognitive deficits or exaggerate existing cognitive deficits
15958117|NCT03201887|Behavioral|optimal effort|Participants will be asked to perform tasks to the best of their abilities.
15958118|NCT03201874|Behavioral|Pain self-management|The program is designed to enhance self-efficacy. The app will guide youth in setting structured and personalized goals aimed at improving their pain and functioning. The pain self-management skills will include personalized CBT-based coping skills including deep breathing, relaxation, and cognitive skills (e.g., staying positive). The app will provide in-the-moment access to pain coping strategies to promote positive changes in mood, behavior, and pain.
15958119|NCT03201874|Behavioral|Education|Education about sickle cell disease to increase disease knowledge
15958120|NCT03201861|Drug|Paclitaxel, Cisplatin|weekly paclitaxel and cisplatin
15958121|NCT03201861|Drug|EC to docetaxel or paclitaxel|Standard adjuvant chemotherapy recommended by guideline
15958122|NCT03201848|Drug|Placebo|Placebo given to subject will be adjusted by body weight (<10kg, Placebo given to subject will be adjusted by body weight(<10kg, half a bag, 2 times a day; 10-20kg; 1 bag, 2 times a day; 20-30kg, 1.5 bag, 2 times a day; 30-50kg, 2 bags, 2 times a day; ≥50kg, 3 bags, 2 times a day;) .
15958123|NCT03201848|Drug|Huaiqihuang Granule|Huaiqihuang Granule given to subject will be adjusted by body weight (<10kg, half a bag, 2 times a day; 10-20kg; 1 bag, 2 times a day; 20-30kg, 1.5 bag, 2 times a day; 30-50kg, 2 bags, 2 times a day; ≥50kg, 3 bags, 2 times a day)
15958124|NCT03201835|Drug|PNL-THC:CBD soft gelatin capsule|3 soft capsules, containing a total of 10.8 mg THC and 10 mg CBD (Each capsule contains 3.6 mg THC and 3.3 mg CBD)
15958125|NCT03201835|Drug|Sativex|spray X 4 actuations
15958126|NCT03201835|Drug|CBD hard capsule dose 1|1 hard capsule containing 10 mg CBD
15958127|NCT03201835|Drug|P-PNL-THC:CBD soft gelatin capsule|2 soft capsules containing a total of 7.2 mg THC, 6.7 mg CBD and 20 mg piperine (Each capsule contains 3.6 mg THC, 3.3 mg CBD and 10 mg piperine)
15958128|NCT03201835|Drug|CBD hard capsule dose 2|1 hard capsule containing 100 mg CBD
15958129|NCT03201822|Other|100 mg of Cocoa Flavanols/70 kg BW|Fruit-flavored non-dairy drink containing 100 cocoa flavanols/70kg BW.
15958130|NCT03201822|Other|200 mg of Cocoa Flavanols/70 kg BW|Fruit-flavored non-dairy drink containing 200 cocoa flavanols/70kg BW.
15958131|NCT03201822|Other|400 mg of Cocoa Flavanols/70 kg BW|Fruit-flavored non-dairy drink containing 400 cocoa flavanols/70kg BW.
15958132|NCT03201822|Other|1000 mg of Cocoa Flavanols/70 kg BW|Fruit-flavored non-dairy drink containing 1000 cocoa flavanols/70kg BW.
15958133|NCT03201809|Device|On-Q|0.2% Ropivicaine at 4 mL/h via On-Q catheter placed sub-pectoral
15958134|NCT03201809|Drug|Ultrasound guided pectoral nerve block|Single Shot Pre-operative injections of 10 mL of 0.25% Ropivicaine for the Pecs 1 injection, and 20 mL of 0.25% Ropivacaine for the Pecs 2 injection
15958135|NCT03201796|Drug|Prulifloxacin 600 mg|Oral administration of one tablet once daily for 28 days of prulifloxacin 600 mg. The investigational drug will be taken with a glass of water, preferably in the evening and at about the same time each day, 2 hours before or at least 4 hours after the eventual administration of cimetidine, antacids containing aluminum and magnesium or preparations containing iron and calcium.
15958136|NCT03201796|Drug|Levofloxacin 500mg|Oral administration of one tablet once daily for 28 days of levofloxacin 500 mg. The investigational drug will be taken with a glass of water, preferably in the evening and at about the same time each day, 2 hours before or at least 4 hours after the eventual administration of cimetidine, antacids containing aluminum and magnesium or preparations containing iron and calcium.
15958137|NCT03201783|Other|immediate frozen-thawed embryo transfer|Frozen-thawed embryo transfer will be performed in the first cycle following the stimulated IVF cycle
15958138|NCT03201783|Other|delayed frozen-thawed embryo transfer|Frozen-thawed embryo transfer will be performed at least in the second cycle following the stimulated IVF cycle
15958139|NCT03201770|Drug|pyronaridine artesunate|Antimalarial treatment
15958140|NCT03201757|Drug|ALKS 3831|Olanzapine + samidorphan, daily oral dosing
15958141|NCT03201744|Procedure|Patients will be randomized to moderate (TOF 1-2) or deep (post tetanic count 1-2) relaxation. Low pressure insufflation (start pressure set at 8 mm Hg)|All procedures will start with low insufflation pressure (8 mmHg). Surgical field assessment (scale 1-5) will be performed every 5 minutes (Martini Br J Anaesth 2014). If conditions are poor (rating 1-2), intraperitoneal insufflation will be incrementally increased (10 mmHg, 12 mmHg, 15 mmHg) every 5 minutes as needed.Reversal of muscle relaxation will be performed at the end of the procedure using established medications used in clinical practice. In theory, deep relaxation may require a more prolonged reversal process, but using contemporary medical agents (sugammadex), reversal from deep relaxation is prompt (2-3 minutes) without any additional delays.
15958142|NCT03201705|Device|Burst + Tonic|Patients fulfilling the inclusion criteria will be enrolled in the study and receive electrocatheter implant (Precision Spectra system, Boston Scientific). Then, they will be observed for a two-weeks trial period in which the efficacy of the stimulation and the compliance of the patient is evaluated. During this trial a Tonic wave stimulation is administered by the external generator. After the trial, the definitive generator will be implanted. Tonic stimulation will be selected as wave form for four weeks. After this period, the stimulation will be switched into the combined waveform for 30 days. At the end of the study period, the final waveform setting of the SCS will be in accord with the patient's stimulation preference.
15958143|NCT03201692|Device|Virtual Reality Treadmill Training|Subjects in the experimental group will receive 40 minutes comprising exercises focused on improving dynamic balance following auditory and visual cues.
15958144|NCT03201692|Device|Treadmill training|Subjects in the active comparator group will receive 40 minutes walking training aimed to improve velocity and endurance.
15958145|NCT03201679|Procedure|Repair of hip fracture|Patients undergoing hip fracture surgery
15958146|NCT03201653|Procedure|Stump closure using NU-KNIT SURGICEL|We would use the Oxidized Regenerated Cellulose as NU-KNIT SURGICEL.
15958147|NCT03201640|Behavioral|slideshow|Participants will be shown a slideshow showing a child being prepared for surgery
15958148|NCT03201640|Behavioral|virtual|Participants will be shown an immersive virtual reality preparation for surgery
15958149|NCT03201627|Drug|Lithium Carbonate|To observe whether lithium carbonate has protective role on the brain of Niemann-Pick disease C1
15958150|NCT03201614|Device|A-CP HA Kit|Patients randomized in this group will receive two injections of platelet-rich plasma/hyaluronic acid prepared with the A-CP HA Kit at Day 0 and Month 2
15958151|NCT03201614|Device|ArthroVisc 40|Patients randomized in this group will receive two injections of hyaluronic acid only (ArthroVisc 40) at Day 0 and Month 2
15958152|NCT03201614|Drug|Placebo|Patients randomized in this group will receive two injections of a saline placebo at Day 0 and Month 2
15958153|NCT03201601|Drug|D-chiro-inositol|Each participant will consume 2 capsules daily of each treatment, in the morning and at night without any restriction in the diet nor in their habits of life. The treatment will last 12 weeks.
15958197|NCT03201328|Other|Videonystagmoscopic study|Rotating sound stimulation on a rotatory armchair and a laborer of Fukuda with sound stimulation and questionary before and after examination.
15958154|NCT03201601|Drug|Myoinositol|Each participant will consume 2 capsules daily of each treatment, in the morning and at night without any restriction in the diet nor in their habits of life. The treatment will last 12 weeks.
15958155|NCT03201588|Dietary Supplement|Formulaid|Arachidonic acids (AA) Docosahexaenoic Acids(DHA) 2:1
15958156|NCT03201575|Device|Remote Ischemic conditioning|A brachial cuff is positioned around the arm of the patient. Four cycles of [5 min brachial cuff inflation at 200 mmHg followed by 5 min of cuff deflation] started as soon as possible after randomization. The intervention is repeated at 12 and 24 hours after inclusion.
15958157|NCT03201575|Device|Patients with no remote ischemic conditioning|A brachial cuff is positioned around the arm of the patient and no inflation or deflation is made.
15958158|NCT03201562|Drug|Aceclidine+tropicamide combination|Ophthalmic Solution
15958159|NCT03201562|Drug|Aceclidine|Ophthalmic Solution
15958160|NCT03201562|Drug|Vehicle|Ophthalmic Solution
15958161|NCT03201549|Dietary Supplement|oral fructose challenge|Participants will consume fructose for two weeks and fast for 8 hours before study visits where they will drink a fructose beverage.
15958162|NCT03201536|Device|conventional Suture|Sutures
15958163|NCT03201536|Device|Zip3|wound closure device
15958164|NCT03201523|Other|Socio-ecologial, community-based intervention|Intervention components will include a health newsletter, health workshops, community evening/health project registration, lay leader training, neighborhood exercise groups, community walking programs with pedometers, healthy cooking contest, and school health promotion activities.
15958165|NCT03201510|Other|Observational|HPTN 075 is an observational study in sub-Saharan MSM
15958166|NCT03201484|Other|FACE-Q questionnaire, 3D photography|FACE-Q questionnaire, 3D photography
15958167|NCT03201471|Drug|Chidamide + R-CHOP regimen|Patients will receive 2 courses of Chidamide+ R-CHOP regimen, the way of administration and dosage of the medicine used in the trial is as follows: Rituximab 375mg//m2, ivgtt,d1;CTX 750mg/m2, ivgtt,d2;EPI 70mg/m2, ivgtt,d2;VCR 1.4 mg/m2, ivgtt, d2; Pred 60 mg/m2,PO, d2-6; Chidamide 20mg/d,d1、4、8、11、14、18;one cycle every 21 days;
15958168|NCT03201458|Drug|Atezolizumab|Given IV
15958169|NCT03201458|Drug|Cobimetinib|Given PO
15958170|NCT03201458|Other|Laboratory Biomarker Analysis|Correlative studies
15958171|NCT03201445|Drug|Filgotinib|200 mg tablet administered orally once daily
15958172|NCT03201445|Drug|Placebo|Tablet administered orally once daily
15958173|NCT03201445|Drug|Standard of Care|Standard of care therapy options may include but are not limited to methotrexate
15958174|NCT03201432|Device|Drug eluting stent (DES)|Polymer-free paclitaxel eluting stents
15958175|NCT03201432|Device|Bare metal stent (BES)|Bare metal stent
15958176|NCT03201419|Drug|FE 201836|Oral solution for daily intake
15958177|NCT03201419|Drug|Desmopressin|Desmopressin Orally Disintegrating Tablet (ODT)
15958178|NCT03201419|Drug|Placebo oral solution|Manufactured to mimic experimental drug
15958179|NCT03201419|Drug|Placebo ODT|Manufactured to mimic experimental drug
15958180|NCT03201393|Drug|Low-dose naltrexone and acetaminophen combination|Twice a day
15958181|NCT03201393|Drug|Placebo|Twice a day
15958182|NCT03201380|Other|TEP scanner with choline|
15958183|NCT03201367|Drug|Rivaroxaban|Rivaroxaban 10 mg/12 hour
15958184|NCT03201367|Other|symptomatic therapy for ascites, abdominal pain|
15958185|NCT03201354|Procedure|Filtration surgery with Ex-PRESS|Filtration surgery with Ex-PRESS
15958186|NCT03201354|Procedure|Non penetrating deep sclerectomy|Non penetrating deep sclerectomy
15958187|NCT03201354|Procedure|Cataract extraction|Cataract surgery and IOL implantation
15958188|NCT03201341|Other|Electrooculogram (EOG)|The acquisition of the surface EOG activity will be carried out by means of 3 surface electrodes, one of which, referred to as a reference, is placed on a bone zone (the glabella, above the nasion) and two others placed on The temples, coupled to an EOG amplifier.
15958189|NCT03201341|Other|Surface Electromyography (EMG)|In behavioral or transcranial stimulation protocols, surface EMG activity may be recorded for further analysis. No protocol included in this project will involve the recording of intramuscular electromyographic activity, which is invasive and involves the implantation of needle electrodes into the muscles.
15958190|NCT03201341|Other|Electrodermal response|The electrodermal response is a useful, simple and reproducible method for recording sweat gland activity that reflects autonomic nervous activity. Recordings will be made using traditional devices, including an amplifier (Delsys or BrainAMP or equivalent) as well as disposable electrodes.
15958191|NCT03201341|Other|Changes in skin temperature|The skin temperature will therefore be recorded during behavioral protocols using techniques for manipulating the representation of the body (perceptual illusion, prismatic deviation, etc.) using a specific measuring device.
15958192|NCT03201341|Other|MRI|Whatever the protocol, a diffusion tensor MRI (DTI) acquisition sequence as well as an image of the entire brain and high spatial resolution (T1 weight, 1x1x1 mm, nasion markers and pre-atrial points) will be acquired (Total duration: 20 minutes).
15958193|NCT03201341|Other|MEG|During the examination, the subject will have to perform tasks comparable to those described for the fMRI procedure, but with the additional possibility, offered by the MEG environment, of performing pointing or seizing of objects, provided that the Trunk and the subject's head be held in place by a suitable restraint system.
15958194|NCT03201341|Other|Transcranial magnetic stimulation (TMS)|TMS is a non-invasive technique that uses very short (~ 100μs) magnetic pulses applied to the scalp to transiently and focally disrupt or improve the functioning of neuronal populations in the underlying superficial cortical regions.
15958195|NCT03201341|Other|Transcranial electrical stimulation in direct current (tDCS)|The tDCS consists in passing a current of low intensity (generally ≤ 1mA to stimulate the cerebral cortex) between an anode and a cathode placed on the scalp, a part of this current crossing the tissues, and in particular the cortical regions situated between these two Electrodes. Generally, if the cathode is placed on the region of interest, it will be inhibited, while it will be energized if the anode is positioned thereon.
15958196|NCT03201328|Other|Audio-vestibular examination|Vestibular tests (videonystagmoscopy and head video impulse test), the tonal and vocal audiogram and the localigramme to the cochlear implanted subjects. Tonal audiometry and localigramme to the healthy subjects.
15958252|NCT03200977|Other|Non-Interventional|Non-Interventional
15958198|NCT03201328|Other|Posturographies study|(stabilometry, sensory preferences, indications of energy consumption) with stereophonic stimulation and questionnaire before and after the examination.
15958199|NCT03201302|Other|School physical education class|Children participated only in school physical education classes only.
15958200|NCT03201302|Other|Taekwondo|Children participated only in taekwondo training only.
15958201|NCT03201302|Other|Martial arts|Children participated only in martial arts training only.
15958202|NCT03201302|Other|Climbing|Children participated only in climbing training only.
15958203|NCT03201302|Other|Volleyball|Children participated only in volleyball training only.
15958204|NCT03201302|Other|Artistic gymnastics|Children participated only in artistic gymnastics training only.
15958205|NCT03201302|Other|Swimming|Children participated only in swimming training only.
15958206|NCT03201302|Other|Dance|Children participated only in dance training only.
15958207|NCT03201302|Other|Basketball|Children participated only in basketball training only.
15958208|NCT03201302|Other|Wrestling|Children participated only in wrestling training only.
15958209|NCT03201302|Other|Football (soccer)|Children participated only in football (soccer) training only.
15958210|NCT03201302|Other|Rhythmic gymnastics|Children participated only in rhythmic gymnastics training only.
15958211|NCT03201302|Other|Track and field|Children participated only in track and field training only.
15958212|NCT03201302|Other|Tennis|Children participated only in tennis training only.
15958213|NCT03201302|Other|Combination of activities 1|Children participated in two weight-bearing activities.
15958214|NCT03201302|Other|Combination of activities 2|Children participated in one weight-bearing activity and in one non weight-bearing activity.
15958215|NCT03201276|Drug|Glucosamine Sulfate|Patients taking glucosamine sulfate 1500mg every day for at least four days.
15958216|NCT03201263|Procedure|Sigh|Application of cyclic pressure control breath delivered at 30 cmH2O for 3 seconds once per minute in patients undergoing pressure support ventilation
15958217|NCT03201263|Procedure|Standard of care|Standard of care
15958218|NCT03201250|Drug|Cabozantinib|"Cabozantinib:
~Phase I: Level -1 = 20 mg or Level 0 = 40 mg or Level +1 = 60 mg, PO daily on days 1-28 Phase II: One of phase I dosing levels identified as MTD, PO daily on days 1-28
~Carfilzomib: 27 mg/m2 IV over 10 min on days 1, 2, 8, 9, 15, 16
~Dexamethasone: 40 mg PO/IV on days 1, 8,15 and 22 (for patient age ≥ 75, acceptable to be given as 20 mg PO/IV on days 1, 2, 8, 9, 15, 16, 22, 23)"
15958219|NCT03201237|Other|Action observation training|Each child observed a task video and then performed a task
15958220|NCT03201224|Device|"After Group"|
15958221|NCT03201211|Biological|Blood sampling|A volume of approximately 20 mL of whole blood should be drawn from each subject, at each study visit, for antibody determination and assay validation/development.
15958222|NCT03201211|Biological|GSK biologicals investigational NTHi Mcat vaccine containing 10µg of PD, PE-PilA and UspA2.|2 doses, not administered as part of this study but administered at Day 0 and Day 60 during STEP 2 of NTHi Mcat-001 (201281 - NCT02547974) study, to subjects who were then enrolled in this study. Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
15958223|NCT03201211|Biological|GSK biologicals investigational NTHi Mcat vaccine containing 10µg of PD, 10µg of PE-PilA, and 3.3µg of UspA2.|2 doses, not administered as part of this study but administered at Day 0 and Day 60 during STEP 2 of NTHi Mcat-001 (201281 - NCT02547974) study, to subjects who were then enrolled in this study. Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
15958224|NCT03201211|Drug|Placebo|2 doses, not administered as part of this study but administered at Day 0 and Day 60 during STEP 2 of NTHi Mcat-001 (201281 - NCT02547974) study, to subjects who were then enrolled in this study. Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
15958225|NCT03201198|Behavioral|Active Life|The Active Life intervention focuses on increasing light physical activity (LPA) with 18 sessions over 10 weeks. Each session starts with 20 minutes of walking followed by functional circuit training. The intensity of the exercises and the speed of execution are adjusted to attain a rating of perceived exertion equal to somewhat hard to hard at the end of each circuit. Sessions end with stretching the major muscle groups. Sessions include a behavioral component (self-efficacy enhancing or confidence building) and health education. Subjects are encouraged to increase their total PA by at least 60 minutes a day, focusing on LPA. After completion of the structured intervention subjects will receive 11 5-minute phone coaching sessions and two booster sessions over the next 12 months.
15958226|NCT03201198|Behavioral|Chair exercises|Chair exercises focus on toning and stretching from a seated position with 18 sessions over 10 weeks. Each session includes 5 minutes of slow stretching, 20 minutes of faster paced exercises, 5 minutes of slower paced stretches, followed by 5-10 minutes of massage and imagery. Guided imagery is used to promote relaxation. Health education includes topics of interest to people with COPD such as basic lung physiology, pathophysiology of COPD, commonly used medications, breathing techniques, healthy eating and physical activity, relaxation, travel considerations, and energy conservation. After completion of the structured intervention subjects will receive 11 5-minute phone coaching sessions and two booster sessions over the next 12 months.
15958227|NCT03201185|Drug|Ramipril|Initial dose: 2,5 mg. Up-titrated at one month to 5 mg and 10 mg at three months (following clinical practice recommendations for up-titration). Target dose: 10 mg (or maximum tolerated dose).
15958228|NCT03201172|Device|Primary Unicompartmental Knee Arthroplasty|Primary implantation of an unicompartmental knee implant
15958229|NCT03201159|Drug|VLX103|150mg tablets
15958230|NCT03201146|Drug|Apatinib|Doses to be determined following the completion of Phase I of the study.
15958231|NCT03201146|Drug|AP or AC|Pemetrexed(A) 500mg/m2, IV, Day 1; Cisplatin(P) 25mg/m2,IV,Day 1-3 or Carboplatin(C) area under curve(AUC)=5, IV, Day 1; AP or AC will be administered every 21 days starting on Day 1.
15958232|NCT03201146|Drug|Apatinib 250mg|250mg/d,q.d.,p.o.every 21 days.
15958233|NCT03201146|Drug|Apatinib 500mg|500mg/d,q.d.,p.o.every 21 days.
15958234|NCT03201146|Drug|Apatinib 750mg|750mg/d,q.d.,p.o.every 21 days.
15958253|NCT03200964|Other|anesthesia given as required for surgical procedure|
15958254|NCT03200951|Drug|Bolus group for epidural block|Randomly selected patients of the bolus group are given 0.3 ml/kg bolus of 0.15% ripivacaine for epidural block.
15958235|NCT03201133|Diagnostic Test|Neuromuscular evaluation|(1) Muscle trunk endurance test; (2) Hip isometric strength (abductor, lateral rotation, extension); (3) Knee extensor isometric strength; (4) unilateral squat; (5) navicular drop test; (6) muscle architecture at rest of gluteus medius, gluteus maximus,vastus lateralis, vastus medialis and rectus femoris; (7) muscle activation during unilateral squat (gluteus and quadriceps muscles); (8) pennation angle of obliques vastus medialis; (9) medial patellofemoral ligament length; (10) knee pain.
15958236|NCT03201120|Behavioral|Outdoor Sun Behavior|Participants will provide informed consent and complete a short background questionnaire about usual sun exposure and protection behaviors and demographics. Next, each participant will be seated in a room to view the audio-visual media messages. Eye-tracking equipment running Paradigm (Perception Research Systems Incorporated) for stimuli presentation will be calibrated to the participant. Subjects will be seated at a desk in front of a computer monitor, keyboard and mouse setup. Each participant will view messages with different emotional appeals related to outdoor sun exposure (seeking shade, covering up, using sunscreen, and multiple behaviors). Messages will be shown in random order, with each message interspersed by a 30 second baseline screen consisting of black background and white, centered plus sign. The last 10 seconds of each preceding the 30-second baseline screen will be used to establish physiologic baseline to minimize carry-over effects of the preceding message.
15958237|NCT03201120|Behavioral|Indoor Tanning Behavior|Upon arrival, participants will provide informed consent and complete a short background questionnaire about usual indoor tanning, sun exposure and protection behaviors, and demographics. Next, each participant will be seated in a room to view the audio-visual media messages. Eye-tracking equipment running Paradigm (Perception Research Systems Incorporated) for stimuli presentation will be calibrated to the participant. Subjects will be seated at a desk in front of a typical computer monitor, keyboard and mouse setup. Each participant will view messages with each type of target behavior (freedom, health risk, appearance)). Messages will be shown in random order, with each message interspersed by a 30 second baseline screen consisting of black background and white, centered plus sign. The last 10 seconds of each preceding the 30-second baseline screen will be used to establish physiologic baseline to minimize carry-over effects of the preceding message.
15958238|NCT03201107|Other|Pilates|"Training based on a basic level Pilates exercise program will be as follows:
~A duration of weeks with a frequency of 2 sessions a week and with a duration of 55 minutes each. The exercises to be performed will be divided into three distinct phases: warm-up, lasting 15 minutes; Main part with a duration of 30 minutes and the return to calm, based mostly on stretching and with a duration of 10 minutes. The repetitions of the exercises will be between 5 and 10 according to the difficulty."
15958239|NCT03201094|Device|Neuromuscular Electrical Stimulation (NMES)|Neuromuscular electrical stimulation twice daily during study period.
15958240|NCT03201094|Dietary Supplement|High Protein Supplementation|High protein supplementation with whey protein shakes taken three times a day during study period.
15958241|NCT03201081|Other|Motivational resistance-training programme|The experimental group exercised at a moderate intensity (8 to 12 repetitions). The load was increased during the 12 weeks from 65% 1-RM to 80% 1-RM. This training load was increased when the individual could perform more than the prescribed number of repetitions (12 repetitions), following the OMNI-RES scale and a hard effort perception level.74 A 1-2 minutes resting period was allowed between sets. During the sessions, the participants were verbally encouraged to perform the complete range of motion for each exercise and received motivational strategies.
15958242|NCT03201068|Dietary Supplement|Probiotic supplement|Probiotic supplement capsule
15958243|NCT03201068|Dietary Supplement|Placebo|Placebo capsule
15958244|NCT03201055|Device|Snore PAP System|The Snore PAP system delivers a set Continuous Positive Airway Pressure (CPAP) and consists of a CPAP flow generator and an approved pillows mask.The system will deliver a fixed positive airflow to the participant via approved tubing and pillows mask.
15958245|NCT03201042|Diagnostic Test|PCR based assay|"Whole blood specimens will be tested for the presence of Borrelia DNA by PCR in a two-step test (Imugen). In Cohort 1a and 1b. The first step tests for the presence of any Borrelia DNA. The second step is employed on positive samples and tests for the presence of either B. burgdorferi DNA or B. miyamotoi DNA. Positivity by PCR has a short but early window in the infection cycle for Borrelia burgdorferi and results may enable this window period and diagnosis rates to be better defined.
~In addition co-infection PCR analysis will be performed for the presence of Babesia, Anaplasma or Ehrlichia DNA (Imugen)."
15958246|NCT03201042|Diagnostic Test|Serology based assay|"The Imugen Lyme Antibody Analysis which includes immunoglobulin M (IgM),immunoglobulin G (IgG), and immunoglobulin A (IgA) antibody capture immunoassay and IgG and IgM based Western blots. In Cohort 1a and 1b.
~The Immunetics C6 Lyme ELISA assay.
~A 2-tier Lyme test performed and interpreted according to Centers for Disease Control (CDC) Guidelines
~A Rickettsia antibody test will be used to identify Spotted Fever and Typhus fever groups infections.
~Lyme test methodologies generally indicate a need to run a combination of tests in order to overcome limitations in either sensitivity or specificity of the various individual tests. Performance of all these tests on the same set of samples should enable both individual and combinatorial performance values to be calculated and compared."
15958247|NCT03201042|Diagnostic Test|Tcell based assay|A research based ELISpot assay will be performed on peripheral blood mononuclear cells (PBMC) extracted from whole blood samples to test for presence of T cells activated against Borrelia antigens. Unlike serology based methods, this signal may not persist over extended periods of time in the absence of Borrelia antigens. The diagnostic window may be different for a test measuring adaptive immune response (i.e. T cells) and thus such test may identify patients with undetectable antibody response and may aid sensitivity of diagnosis.
15958248|NCT03201016|Diagnostic Test|Bone densitometry|Procollagen Type I Propeptides, alkaline phosphatase, Crosslinked Telopeptides of Type I Collagen
15958249|NCT03201003|Biological|AR101 powder provided in capsules & sachets|Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
15958250|NCT03201003|Other|Placebo powder provided in capsules & sachets|Study product formulated to contain only inactive ingredients for use as defined in the protocol
15958251|NCT03200990|Device|iVAC2L pVAD|To determine the effects of the new PFLVAD PulseCath® iVAC2L on ventricular loading using left ventricular pressure-volume loops, in association with systemic and pulmonary hemodynamic parameters obtained from right and left catheterization. Additionally, assessments of specific load and flow-dependent humoral factors, and cardiac enzymes, will be made during and after the use of mechanical circulatory support.
15958255|NCT03200951|Drug|Infusion group for epidural block|Randomly selected patients of the infusion group are given 0.3 ml/kg/hr 0.15% ripivacaine for epidural block.
15958256|NCT03200938|Device|formocresol and zinc oxide.|Removal of the coronary pulp from primary molar teeth, use of formocresol and zinc oxide
15958257|NCT03200938|Device|PBS CIMMO cement.|Removal of the coronary pulp from primary molar teeth, use of PBS cement
15958258|NCT03200925|Other|"Jumping into Kangaroo Care - a video created by the Ohio Department of Health"|The video is 8 minutes and 52 seconds in length. The video discusses the benefits and logistics of Kangaroo Care from professional's perspectives and from new mother's perspectives.
15958259|NCT03200912|Drug|Ingenol Mebutate (Picato®)|Brand product
15958260|NCT03200912|Drug|Generic Ingenol Mebutate|Generic formulated to have the same therapeutic effect of the brand
15958261|NCT03200912|Drug|Vehicle Foam|It does not contain active ingredient. A placebo to test the sensitivity of the active treatments.
15958262|NCT03200899|Behavioral|MAPSS-MS|MAPSS-MS is a computer-assisted cognitive rehabilitation intervention. It is a combination of home computer training and 8-weeks of group sessions on lifestyle change and compensatory cognitive strategies.
15958263|NCT03200899|Other|Usual Care plus computer games|"Participants assigned to this arm receive their usual medical care and referral to the My Brain Games website."
15958264|NCT03200886|Device|Sinovial H-L|Patients were treated with an hybrid form of hyaluronic acid (Sinovial H-L) obtained through thermo-chemical processes from the combination of high (1100-1400 kDa) and low (80-100 kDa) MW fractions.
15958265|NCT03200886|Drug|Triamcinolone Acetonide|The patients have received two i.a. injections (at baseline and 15 days apart) of 0.5 ml of triamcinolone acetonide (Kenacort® 20 mg, Bristol-Myers Squibb Srl)
15958266|NCT03200873|Device|repetitive transcranial magnetic stimulation|Each session of iTBS will apply3 trains of 600 pulses to the RDLPFC, with 20 2-second trains and an 8-second inter-train interval. Sham iTBS condition will be administered with the same methodology used for active iTBS condition with a sham coil mimicking noises and vibrations without delivery of magnetic pulses.
15958267|NCT03200860|Drug|Empagliflozin 10 MG|10 mg daily, oral, 30 days
15958268|NCT03200860|Drug|Placebo Oral Tablet|Matching Placebo, 10 mg daily, oral, 30 days
15958269|NCT03200847|Drug|Pembrolizumab with All-Trans Retinoic Acid|All the patients will receive 200mg Q3W pembrolizumab treatment plus the supplemental treatment of 150 mg/m2 All-Trans Retinoic Acid orally for 3 days surrounding each of the first four infusions of pembrolizumab
15958270|NCT03200834|Procedure|Right Hemicolectomy with D2 lymph node dissection|Remove right part of colon with lymph node dissection №201, №202, №211, №212 (if present), №221,№222 (Japanese classification).
15958271|NCT03200834|Procedure|Right Hemicolectomy with D3 lymph node dissection|Remove right part of colon with lymph node dissection №201, №202, № 203, №211, №212 (if present), №213 (if present) №221,№222, №223 (for hepatic flexure and proximal part of transverse colon cancer)(Japanese classification).
15958272|NCT03200821|Biological|G17DT|250 µg/0.2 mL administered by intramuscular injection at Weeks 0, 2 and 6. 125 µg booster administered at Week 24.
15958273|NCT03200821|Drug|Gemcitabine|1000 µg/m^2 intravenously administered once weekly for seven weeks starting at Week 0 followed by one week of rest. After, treatments will occur in cycles of 3 weeks of treatment followed by one week of rest.
15958274|NCT03200808|Drug|mixed methylene blue compound injection|Every patient received intradermal mixed methylene blue compound injection twice.
15958275|NCT03200795|Other|Rebound exercise|"Each participant will undergo 3 sessions a week for 8 weeks with each session lasting 20 minutes. Bouncing frequency will be determined by signals from an metronom and will be set at between 90 and 120 bounces per minute. Heart rate training zone will be maintained, during the exercise, at moderate intensity of 40-60% and will be calculated using the Karvonen formula ([Heart rate reserve x training percentage] + resting heart rate)(Nuhu & Maharaj, 2017).
~The exercise will involve bouncing on the center portion of the mini trampoline (Portable 2013 Model Half-Fold Cellerciser with feet slightly apart and knees in full extension. Each foot strike equaled one step or bounce with step height, this will be defined as the distance between the foot at maximum height of jump and the bed of the center of the trampoline ranging between 10 and 15 cm (Nuhu & Maharaj, 2017)."
15958276|NCT03200795|Other|Circuit training exercise|"Participants will be instructed to exhale while lifting a weight and inhale while lowering it, to minimize blood pressure excursions, and to rest for 2 to 3 minutes between sets. Participants will perform 1 set per resistance exercise three time weekly for the first 2 weeks and 4 sets of each resistance exercise three time weekly during weeks 3 and 4. Resistance will be increase by 5 to 10 kg when the participant could perform more than 15 repetitions while maintaining proper form.
~All aerobic activities of the circuit training will be performed on a cycle ergometer or treadmill. Participants are free to vary the machine used from one visit to the next. Exercise intensity will be standardized by using heart rate monitors (Polar Electro Oy) that will display the participant's heart rate and emitted a warning signal when the heart rate was outside the prescribed training zone, thus guiding the participant in adjusting the workload up or down to achieve the desired intensity."
15958277|NCT03200782|Drug|Empagliflozin|Glucose lowering effect of empagliflozin for reducing the counter-regulatory glucose-lowering response
15958278|NCT03200782|Drug|Anakinra|IL-1Beta blockage effect on insulin secretion and thereby influencing postprandial glucose level
15958279|NCT03200782|Other|oral placebo (winthrop tablet)|subcutaneous placebo (0.67 ml of 0.9% sodium chloride) 3 hours before the test meal and an oral placebo (winthrop tablet) 2 hours before the test meal will be administered by an Independent nurse to the blinded patient
15958280|NCT03200782|Other|subcutaneous placebo (0.67 ml of 0.9% sodium chloride)|subcutaneous placebo (0.67 ml of 0.9% sodium chloride) will be administered in arm 'Placebo-Placebo' and arm 'drug: Empagliflozin'
15958281|NCT03200769|Device|CPAP active|CPAP PR1 Philips Respironics with a pression between 4 and 14 mm Hg
15958282|NCT03200769|Device|CPAP placebo|CPAP PR1 Philips Respironics with a constant pression of 4 mm Hg.
15958283|NCT03200756|Behavioral|Sedentary Group|The sedentary group undergoes a behavioral intervention to reduce sedentary behavior which includes a patient centered approach with monitoring and goal setting.
15958284|NCT03200756|Behavioral|Exercise Group|The Active Comparative group undergoes a standard clinical approach to increase exercise which is patient centered with monitoring and goal setting.
15958285|NCT03200730|Behavioral|Family Dignity Intervention group|A brief psychotherapeutic intervention offered to a family dyad (i.e., patient and one identified family caregiver) using narrative approach with life review elements. The purpose is to facilitate an open dialogue between the family dyad that strengthens family connectedness and emotional connection.
15958286|NCT03200717|Drug|pazopanib|"Pazopanib is taken orally and will be administered daily as a fixed dose. Enrollment of 3rd-line patients will be restricted to ensure approximately 40 patients receive pazopanib as 2nd-line therapy.
~Number of Cycles: until progression, unacceptable toxicity develops, death, pregnancy, start of new anti-cancer therapy, doctor/patient discontinuation, lost to follow-up, end of study, or study termination by sponsor."
15958287|NCT03200704|Combination Product|IC2000 and SPY-PHI|Investigational treatment to assess the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an intraoperative fluorescence visualization tool, in the visual identification of lymphatic vessels and lymph nodes (LNs) during lymphatic mapping and sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer
15958288|NCT03200704|Combination Product|Tc-99m radioactive colloid and Gamma Probe|Comparator; standard of care for sentinel lymph node biopsy (SLNB) procedures in early stage breast cancer
15958289|NCT03200691|Radiation|3-DCRT or IMRT radiation|Radiation of primary tumor and local lymph nodes with 95% planning target volume (PTV) of 40 Gy/20f.
15958290|NCT03200691|Drug|anti-PD-1 antibody SHR-1210|SHR-1210 (200mg fixed dose every 2 weeks for 2 cycles) will be administered as an intravenous infusion over 60 minutes.
15958291|NCT03200678|Other|isokinetic assessment|muscle torque assessement
15958292|NCT03200665|Diagnostic Test|Ultrasound 35-36 (6 / 7 days weeks)|An obstetric ultrasound will be performed at 35-36 (6 / 7 days weeks) including biometric parameters and functional parameters of the fetus
15958293|NCT03200652|Dietary Supplement|Metabolic availability of lysine in wheat|Four levels of lysine intakes will be provided by the reference protein drinks, 3 levels of lysine from wheat and 1 level from wheat with lentils.
15958294|NCT03200639|Other|Combined training|The CT and CTc protocol (total length time ~60 min) were performed three times a week for 12 weeks, in nonconsecutive days, and were composed by 30-min walk at 70% of maximum heart rate or Borg Scale at 5-6 following resistance exercises (RE: 45-degree half squat, bench press, leg curl, rowing machine and unilateral leg extension) at 70% of one repetition maximum (1RM) with three sets of 8-12 repetitions and 1.5 min rest interval between sets and exercises. If the volunteer exceeded or did not reach the walk intensity, the volunteer was stimulated by to decrease or increase the walk speed, respectively. Regarding the resistance exercises, the load was adjusted in the 6th week with the 1RM test to ensure the 70% of 1RM between 8-12 repetitions.
15958295|NCT03200639|Other|High intensity interval training with body weight|The HIITBW and HIITBWc protocol (total length time ~28 min) were performed three times a week for 12 weeks, in nonconsecutive days, and were composed by ten sets of 60 s of high (vigorous) intensity exercises at 80-95% of HRmax or Borg Scale at 8-9 (i.e. 30s of stepping up and down on a step and 30s of squatting up and down as fast as possible) interspersed with a recovery of 60 s of light walk (<60% of HRmax or Borg Scale at <5). To ensure vigorous zone of all sets, if the volunteer exceeded or did not reach the vigorous zone the volunteer was stimulated by the fitness professionals to decrease or increase the number of steps and squats, respectively.
15958296|NCT03200626|Procedure|Autologous hematopoietic cell transplant|Autologous hematopoietic cell transplant
15958297|NCT03200613|Drug|Apixaban|2.5 mg orally twice daily
15958298|NCT03200613|Drug|Low molecular weight heparin|Dalteparin 5000 units daily or Enoxaparin 40 mg subcutaneous daily
15958299|NCT03200600|Drug|Dexamethasone|Dexamethasone 10 mg is administered before anesthesia induction.
15958300|NCT03200600|Drug|Normal saline|Normal saline 2 ml is administered before anesthesia induction.
15958301|NCT03200600|Drug|Flurbiprofen axetil|Flurbiprofen axetil 50 mg is administered before the start of surgery. Postoperative analgesia is provided with a patient-controlled analgesia pump, which is established with 100 ml of 1.25 μg/ml sufentanil and 2 mg/ml flurbiprofen axetil, programmed to deliver a 2 ml bolus with a lockout interval of 6-8 min and a background infusion of 1 ml/h.
15958302|NCT03200600|Drug|Lipid microsphere|Lipid microsphere 5 ml is administered before the start of surgery. Postoperative analgesia is provided with a patient-controlled analgesia pump, which is established with 100 ml of 1.25 μg/ml sufentanil and 20 ml lipid microsphere, programmed to deliver a 2 ml bolus with a lockout interval of 6-8 min and a background infusion of 1 ml/h.
15958303|NCT03200587|Drug|Avelumab|Avelumab 10 mg/kg infusion every 2 weeks (Days 1 and 15) of every 28 day cycle for up to 12 cycles
15958304|NCT03200587|Drug|Cabozantinib|Cabozantinib oral daily at 20 (starting dose 1), 40 (Dose Level 2) or 60 mg (Dose Level 3)
15958305|NCT03200574|Diagnostic Test|4D Cardiac CT Scan|4D CT scan obtained at minimum of 1 month after the discontinuation of the anticoagulation or dual antiplatelet therapy
15958306|NCT03200574|Device|LivaNova Bioprothetic Aortic Valve Implant|Study includes patients that have received the commercially approved LivaNova bioprosthetic aortic heart valve Perceval, as standard of care.
15958307|NCT03200561|Drug|Prednisolone|Prednisolone 2mg/Kg/day for 5 days
15958308|NCT03200561|Biological|immunoglobulin|immunoglobulin 2g/Kg for 12 hours
15958309|NCT03200548|Behavioral|Relaxing acupressure plus usual care|Experimental group. Self-administered acupressure is one possible safe, self-management technique for which may be effective for improving fatigue as well as physical and psychosocial functioning in several chronic disease populations. Acupressure, a technique derived from acupuncture, is a component of Traditional Chinese Medicine (TCM) in which pressure is applied to specific acupoints on the body using a finger or small device, to treat disease.
15958310|NCT03200548|Behavioral|Usual care|Negative control group. Participants are asked to carry on with their usual management practices and habits.
15958311|NCT03200548|Behavioral|Stimulating acupressure plus usual care|Experimental group. Self-administered acupressure is one possible safe, self-management technique for which may be effective for improving fatigue as well as physical and psychosocial functioning in several chronic disease populations. Acupressure, a technique derived from acupuncture, is a component of Traditional Chinese Medicine (TCM) in which pressure is applied to specific acupoints on the body using a finger or small device, to treat disease.
15958312|NCT03200548|Behavioral|Sham acupressure plus usual care|Positive control group. Chosen pressure points are not known to be effective.
15958313|NCT03200535|Other|EHR gaps|Gaps will appear in the electronic health record and patient portal in order to prompt referral by provider or patient
15958314|NCT03200535|Other|Bulk outreach|A bulk letter or email will be sent
15958315|NCT03200535|Other|Dietician call|Patients will receive a personalized call by a registered dietitian
15958316|NCT03200522|Other|Prudent diet|Six days of meals provided with high amounts of fruits and vegetables, whole grains, fiber, omega-3 fatty acids, low-fat dairy products, and overall high levels of antioxidants.
15958317|NCT03200522|Other|Western diet|Six days of meals provided with high amounts of processed foods, fast foods, sweets, omega-6 fatty acids, and a low intake of fiber.
15958318|NCT03200509|Other|Physical Activity Intervention|Participants will receive a group exercise program, health coaching sessions and an activity monitor.
15958319|NCT03200509|Other|Control group|Participants will receive a group exercise program, sham health coaching sessions and a sham activity monitor.
15958320|NCT03200496|Drug|DA-5206(Fasting)|Test drug l : DA-5206(Fasting)
15958321|NCT03200496|Drug|DA-5206(Fed)|Test drug ll : DA-5206(Fed)
15958322|NCT03200496|Drug|TALION®|Reference drug : Talion®
15958323|NCT03200483|Other|Control Protocol|In this period the volunteers were at rest, in the supine position for 15 minutes, followed by 30 minutes of aerobic exercise on a treadmill (five minutes at a speed of 6.0 km / h followed by 25 minutes with 60% of Vmax + 1% grade) and then a recovery period lasting 60 minutes (three minutes standing on the treadmill followed by 57 minutes in the supine position). The volunteers were instructed to remain awake during all the protocol and this was verified and monitored by one of the researchers.
15958324|NCT03200483|Other|Classical Music Protocol|Volunteers accomplished the same activities of the control protocol, but with exposure to classical music during exercise and recovery.
15958325|NCT03200483|Other|Rock Music Protocol|Volunteers accomplished the same activities of the control protocol, but with exposure to rocky musical style during exercise and recovery.
15958326|NCT03200470|Other|No intervention: sample collection study|Sample collection and collection of laboratory values
15958327|NCT03200457|Device|1,5 Tesla abdominal MRI|Measurement of the fat and iron
15958328|NCT03200457|Device|3 Tesla abdominal MRI|Measurement of the fat and iron
15958329|NCT03200444|Other|Standard adhesive 1|This strip consists of a standard hydrocolloid adhesive found in ostomy products
15958330|NCT03200444|Other|Standard adhesive 2|This strip consists of a standard hydrocolloid adhesive found in ostomy products
15958331|NCT03200444|Other|Standard adhesive 3|This strip consists of a standard hydrocolloid adhesive found in ostomy products
15958332|NCT03200444|Other|P-4|Newly developed adhesive P-4
15958333|NCT03200444|Other|P-15|Newly developed adhesive P-14
15958334|NCT03200444|Other|P-16|Newly developed adhesive P-8
15958335|NCT03200431|Other|New adhesive strip|This is a newly developed strip.
15958336|NCT03200418|Other|Standard hydrocolloid adhesive|This patch is made of standard hydrocolloid adhesive
15958337|NCT03200418|Other|P-4|This patch is made of new adhesive
15958338|NCT03200418|Other|P-15|This patch is made of new adhesive
15958339|NCT03200418|Other|P-16|This patch is made of new adhesive
15958340|NCT03200405|Device|DynaMeshVisible|The umbilical hernias will be fixed with a mesh. In this group a MRI-visible mesh will be used.
15958341|NCT03200405|Device|DynaMeshCICAT|The umbilical hernias will be fixed with a mesh. In this group a non-visible mesh will be used.
15958342|NCT03200392|Device|laser root surface conditioning & laser DGG harvesting|laser root surface bio-modification (single application) and placement of harvested de-epithelialized gingival graft (DGG) followed by coronal repositioned flap for gingival recession Miller's I, II defect coverage
15958343|NCT03200392|Device|laser root surface conditioning & blade DGG harvesting|laser root surface bio-modification (single application) and scalpel blade harvesting of de-epithelialized palatal graft (Zucchelli et al. 2010) and coronal repositioned flap for gingival recession Miller's I, II defect coverage
15958344|NCT03200392|Procedure|blade DGG harvesting|De-epithelialized palatal graft harvested using scalpel blade (Zucchelli et al. 2010) and coronal repositioned flap for gingival recession defect coverage
15958345|NCT03200379|Other|directly acting antivirals (DAAs)|Eligible subjects would be those CHC patients who receive approved DAA in the daily practice in Taiwan. No clinical developing medications will be allocated patients.
15958346|NCT03200366|Behavioral|Tailored DVD|"A 20 minute tailored DVD titled Approaches to Colon Testing is viewed by participants. It is designed to encourage CRC screening uptake by colonoscopy or FIT by increasing the participant's CRC knowledge and beliefs about the benefits of screening, reducing barriers to screening, and increasing self-efficacy for screening by demonstrating how these tests are performed."
15958347|NCT03200366|Behavioral|Patient Navigation|Participants talk by telephone with a Patient Navigator who is a trained nurse. The Patient Navigator determines if participants viewed the tailored DVD and answers any questions about the content. The Patient Navigator then provides telephone counseling on CRC and screening tests to: (1) increase knowledge, perceived benefits, and self-efficacy; (2) reduce barriers; (3) enhance access; and (4) provide social support.
15958348|NCT03200353|Device|system NATROX (device name)|system NATROX (device name) application on the wounds of lower limbs
15958349|NCT03200340|Drug|EC-18|Oral administration of EC-18 twice daily
15958350|NCT03200340|Drug|Placebo|Placebo to match EC-18 capsule administration
15958351|NCT03200327|Procedure|promontofixation|reconstruction of cystoceles using a subvesical prosthesis
15958352|NCT03200327|Procedure|sacrospinofixation|Utero-vaginal suspension by bilateral anterior sacrospinofixation using the vaginal route
15958353|NCT03200314|Other|Measurment of blood recirculation|Ultrasound based measurments of blood recirculating through the vvECMO circuit.
15958382|NCT03200015|Drug|Metformin|Potentially increasing the efficacy and safety of standard chemotherapy through several mechanisms
15958418|NCT03199781|Device|Motorized mechanical massage with the Dermothonus Slim® Ibramed with cosmetics|Patients will be treated with motorized mechanical massage with the Dermothonus Slim® electromedical equipment (Ibramed- Brazilian Industry of Electrical Equipment) associated with cosmetics with lipolytic active principle, being performed twice a week totaling 10 sessions by a dermato-functional physiotherapist.
15958419|NCT03199755|Drug|ACT|Current approved drug for treating malaria
15958354|NCT03200301|Procedure|Intact Umbilical Cord Milking|Immediately after delivery, the infant will be placed at or ∼20 cm below the level of the placenta and about 20 cm of the intact umbilical cord will be milked towards the umbilicus three times. The technique consists of pinching the cord close to the placenta and milking about 20 cm segment of the cord proximal to the umbilicus, towards the infant over a 2-second duration. The cord will then be released and allowed to refill with blood for a brief 2-second pause between each milking motion. After completion of milking three times, the cord will be clamped close to the umbilicus and the neonate handed over to the neonatal team. The procedure of cord milking will be completed within 20 seconds.
15958355|NCT03200288|Device|HL-01: high and low molecular weight hyaluronic acid|2 ml intra-articular single injection
15958356|NCT03200288|Device|Placebo|2 ml intra-articular single injection
15958357|NCT03200275|Diagnostic Test|Immunocatch™ Legionella Urine Antigen Test|A total number of 503 urine specimens from study participants will be tested with LUAT - Immunocatch™. This test utilises the immunochromatographic (ICT) membrane assay to detect antigenuria which has revolutionized the usage of UAT to diagnose Legionella infections. The results can be obtained within minutes and the test does not require any sophisticated laboratory support. A comparison of the ICT with the Enzyme Immuno Assay (EIA) test showed comparable performance characteristics.
15958358|NCT03200249|Radiation|Preoperative chemo-radiation with IG-IMRT dose escalation|
15958359|NCT03200236|Behavioral|Intensive Telephone Counseling (8 sessions) with nicotine replacement|Participants are provided up to 8 counseling sessions lasting approximately 20 minutes each and access to 8-weeks of free nicotine replacement patches. A counselor-initiated discussion of screening results will also be included throughout the counseling sessions.
15958360|NCT03200236|Behavioral|Usual Care: Telephone counseling (3 sessions) with nicotine replacement|Participants are provided up to 3 counseling sessions lasting approximately 20 minutes each and access to 2-weeks of free nicotine replacement patches.
15958361|NCT03200223|Behavioral|Personalized healthcare service|Personalized healthcare service, such as exercise recommendation, lifestyle activity coaching, health data monitoring
15958362|NCT03200210|Drug|Febuxostat|Febuxostat tablets would be given to patients at dose of 20mg/d, once a day, and dose would be adjusted according to serum uric acid at specific visits.
15958363|NCT03200210|Drug|Placebo|Pills manufactured to mimic Febuxostat tablets
15958364|NCT03200197|Other|Menthol chewing gum|The experimental group received one unit of mentholated chewing gum, chewing and swallowing the saliva in a natural rhythm for 10 minutes. The menthol chewing gum used is called TRÍDENT®and is composed as follows: base gum, hydrogenated vegetable oil, vegetable oil, sweeteners: sorbitol, xylitol, mannitol, maltitol, aspartame, acesulfame potassium, and sucralose, humectants: glycerin and triacetin, flavorings (contains wheat derivatives), anti-humectant talc, emulsifiers: esters of mono- and diglycerides of fatty acids with acetic acid, soy lectin and mono and diglycerides of fatty acids and colorings: tartrazine and brilliant blue FCF, presenting a weight of 1.8g per unit.
15958365|NCT03200197|Other|Usual care (fasting)|The control group received the usual care given at the hospitalization units, that is, when the patient reported thirst, the need to maintain fasting for 10 minutes was reaffirmed.
15958366|NCT03200184|Drug|sofosbuvir and daclatasvir|A fixed dose combination pill containing 400mg sofosbuvir and 60 mg daclatasvir given daily for 12 weeks. If a patient is cirrhotic, treatment duration would be 24 weeks.
15958367|NCT03200158|Other|Endoscopy biopsy and blood|Medical operation
15958368|NCT03200145|Other|ACP intervention|"The intervention group made by persons living in nursing homes using a person centered attention model relying on two dimensions:
~- Attention to the person based on:
~Knowledge of the person in several dimensions (biological, psychological, social, etc), interests and preferences.
~Respect and acknowledge of the person.
~Promotion of the autonomy.
~Personalized treatment, with tailored attention and integrative cures
~Protection of physical well-being, preventing damages and risks and promoting healthy habits.
~Promotion of independence on daily activities.
~Protection of privacy and personal matters
~- Positive environment based on:
~Physical space, including accessibility, comfort, homely environment, with stimulating spaces for physical activity, social relationships and significant activities for the persons.
~Social relationships, with proximity and collaboration with families.
~Friendly organization, with empathetic professionals empowering users."
15958369|NCT03200132|Diagnostic Test|Cardiac PET/MRI|For patients undergoing 18-Fluor- fluorodeoxyglucose (18F-FDG) PET/MRI or PET/Computed Tomography (CT), additional cardiac PET/MRI scans are acquired.
15958370|NCT03200119|Behavioral|Daily health-related lifestyle modification prescription|Daily health-related lifestyle modification prescription
15958371|NCT03200106|Device|Alfapump|Alfapump implant
15958372|NCT03200093|Drug|Oral Vancomycin|Oral vancomycin solution 125 mg in 2.5 mL combined with 2.5 mL Ora-Sweet. A total of 5 mL combined solution taken by mouth once daily.
15958373|NCT03200093|Drug|Placebo|Ora-Sweet 5mL taken by mouth once daily.
15958374|NCT03200080|Drug|Tozadenant|2, 4, 6 or 8 Tozadenant 60 mg tablets
15958375|NCT03200080|Drug|Placebo oral tablet|2, 4, 6 or 8 Tozadenant matching placebo tablets
15958376|NCT03200080|Drug|d-amphetamine|2 or 4 capsules, each containing 2 over-encapsulated d-amphetamine 5 mg tablets
15958377|NCT03200080|Drug|Placebo oral capsule|2 or 4 capsules, each containing d-amphetamine matching over-encapsulated PLACEBO 200 mg lactose tablet
15958378|NCT03200067|Behavioral|Personalized health care service|Personalized health care service, such as rehabilitation exercise recommendation, lifestyle activity coaching, health data monitoring
15958379|NCT03200054|Other|Adherence Clubs|Women will be referred to the ACs at their postpartum ART clinic visit at the midwife obstetric unit (MOU) at the Gugulethu community health centre (CHC). AC visits occur 2-4 monthly at a community hall near the CHC. At routine visits, which last ~1 hour, community health workers provide health education, weigh participants, ask about symptoms, and dispense pre-packed ART. Symptomatic participants are referred back to the main ART facility at the CHC for assessment by a nurse. A nurse performs routine phlebotomy at an annual club visit, and does a clinical assessment and reviews blood results at the subsequent visit. Participants requiring more regular follow-up and those with raised viral loads are referred back to the ART clinic at the CHC by the nurse.
15958380|NCT03200041|Procedure|Blood sample|20 ml blood sample taken from vein in arm
15958381|NCT03200028|Other|Computerized Plasticity-Based Adaptive Cognitive Training|Thirty minutes of training on computerized exercises that targets executive function, memory and attention.
15958383|NCT03200002|Drug|Cyclophosphamide|Cyclophosphamide injection was administered in the dose of 0.5 to 1 gram per m2 of body surface area. The medicine, which is available in the strength of 1 gram in powder form, was first dissolved in 20 ml of normal saline. Only15 ml of this preparation was mixed in 100 ml of normal saline and was infused over a period of one hour. CYC was not given to those patients who had total leukocyte counts (TLC) less than 2500/mm3. Those patients were re-evaluated after one week and intravenous pulse CYC was reinstituted if the TLC exceeds 2500/mm3. Pulse CYC was administered every month for a total of six infusions.
15958384|NCT03200002|Drug|Mycophenolate Mofetil|Participants in the MMF group were administered tablet mycophenolate mofetil at a starting dose of 500 mg twice daily if the weight of the patient was less than 50 kilograms and 750 mg twice daily if the weight was more than 50 kilograms. After one month, the dose of MMF was increased to 750 mg twice daily. The clinical response was monitored in terms of reduction in serum creatinine and proteinuria. MMF dose was decreased or interrupted in patients experiencing an absolute neutrophil count <1300/mm3 at any study visit; MMF treatment was discontinued if a patient experienced an absolute neutrophil count <1000/mm3.
15958385|NCT03199989|Drug|CapeOX（Capecitabine+Oxaliplatin）|Patients enrolled in the chemotherapy group would receive postoperative chemotherapy CapeOX（Capecitabine+Oxaliplatin）for 6 months
15958386|NCT03199989|Other|Observation|Patients enrolled in the observation group would not receive any chemotherapy drugs just for observation
15958387|NCT03199976|Drug|Tiotropium Bromide|Tiotropium Bromide 2.5 µg/dose inhaled aerosol
15958388|NCT03199976|Drug|Fluticasone Propionate|Fluticasone Propionate 125 µg/dose inhaled aerosol
15958389|NCT03199976|Drug|Salbutamol|Salbutamol 0.1 mg/dose inhaled aerosol
15958390|NCT03199963|Drug|4-OH tamoxifen|4-Hydroxytamoxifen (afimoxifene) gel
15958391|NCT03199963|Drug|Placebo|An absorptive hydroalcoholic gel preparation of the same ingredients as BHR-700, but without 4-OHT.
15958392|NCT03199950|Drug|Haloperidol|Haloperidol 2dd1mg (08.00am - 10.00pm)
15958393|NCT03199950|Drug|Placebo Oral Tablet|Placebo oral 2dd (08.00am - 10.00pm)
15958394|NCT03199937|Behavioral|Flexible Futures|Flexible Futures is a novel and innovative cognitive-behavioral treatment that directly addresses executive function and self-regulation deficits in ASD. Flexible futures targets flexibility and planning through self-regulatory scripts that are consistently modeled and reinforced. Scripts compensate for the inner speech and organization/integration deficits in ASD, and are practiced repeatedly to achieve automaticity. Content focuses on key functions needed for college success, such as: intrinsic motivation, how to implement skills socially, self-advocacy skills application of flexibility and organization scripts and strategies in the service of a long-term goal, and management of time and priorities.
15958395|NCT03199937|Other|Current standard of care|Flexible Futures will be compared to a social skills treatment as usual that capitalizes on current standard of care provided by local school districts.
15958396|NCT03199924|Drug|Diclofenac|Intramuscular injection of 75mg / 3ml of Diclofenac solution
15958397|NCT03199924|Drug|Magnesium Sulfate|intravenous injection of 1 g magnesium solution diluted in 10ml of saline solution administered over 2 minutes
15958398|NCT03199924|Drug|Lidocaine|intravenous injection of 10ml lidocaine 1% solution administered over 2 minutes
15958399|NCT03199911|Drug|Topical Antibiotic Product|Topical antibiotic ointment will be erythromycin or bacitracin. If the patient cannot obtain either (e.g. lack of availability at the pharmacy), bacitracin polymyxin will be prescribed. Allergy to all 3 study drugs means that a patient will be excluded from the study.
15958400|NCT03199911|Drug|Topical Non-Antibiotic Ointment|Mineral oil/petrolatum-based artificial tear ointment.
15958401|NCT03199898|Diagnostic Test|Silverman-Andersen Retraction Score|The Silverman-Andersen Retraction Score (SAs) is used to assess severity of respiratory distress in newborn and preterm infants without respiratory support.The score comprises 4 inspiratory categories of movements (thoraco-abdominal, intercostal, xiphoid, and chin movements) and one expiratory category (grunting).
15958409|NCT03199872|Biological|RV001V|Sc injection
15958410|NCT03199846|Other|Non-Interventional|Non-Interventional
15958411|NCT03199833|Device|RETRAINER-S2|"It consists of the execution of different exercises with the affected forearm-hand supported by the RETRAINER-S2 device. The subject is actively involved in the exercises and the system provides two types of support: wrist-fingers motion constraining and FES. The following exercises can be performed: controlled wrist flexion and wrist extension; controlled fingers flexion and extension; repeated grasping of an object; anterior reaching and grasping of an object; moving of objects on a plane or in space.
~A subset of exercises is defined based on the patient's capability and the training time is equally shared between the selected exercises. The different training sessions can include different exercises and a different number of repetition for each exercise."
15958412|NCT03199833|Other|Conventional therapy|"It consists of a combination of different treatment modalities among the following, based on the patient's specific needs:
~Upper limb passive motion
~Arm Cycle ergometer with or without FES
~Neuro Muscular Electrical Stimulation
~Upper limb exercises using augmented or virtual reality environment
~Occupational therapy exercises
~Constraint induced movement therapy
~Upper limb active movement (reaching, grasping, elevation, spatial orientation)
~Repetitive task training
~Mirror therapy
~Writing training
~Chemodenervation Therapy"
15958413|NCT03199820|Device|Cook cervical balloon|trans-cervical balloon catheter for out-patient labour induction
15958414|NCT03199820|Drug|Prostin E2 Vaginal Suppository|Propess Vaginal suppository for out-patient Labour induction
15958415|NCT03199807|Biological|NRT|Peripheral blood lymphocytes will be collected and neoantigen reactive T cells(NRTs) will be generated in the laboratory. NRTs 0.5~1 x 10^10, will be i.v.Q3 weeks for total 4-6 doses.
15958416|NCT03199807|Radiation|Radiotherapy|Radiotherapy of the major mass by dose of 5Gy/F * 10F
15958417|NCT03199794|Biological|OBIZUR|Treating physician will determine treatment regimen and frequency of laboratory and clinical assessments according to routine clinical practice.
15958420|NCT03199755|Drug|DLA1|Experimental drug treatment, single dose.
15958421|NCT03199755|Drug|DLA2|Experimental drug treatment, doubled the dose of DLA1.
15958422|NCT03199742|Behavioral|Personalized App Coaching|All coaching messages will be based on how each participant responds to baseline survey questionnaires and how they interact with the experimental mobile phone application during the course of the study. Participants will be provided with feedback about recent progress & use of the app, information about coping strategies provided by the app, and a recommendation for making the best use of the app over the subsequent few days.
15958423|NCT03199742|Behavioral|Active Comparator|Mobile phone application providing extensive information about PTSD and treatment, tools for managing PTSD symptoms, self-monitoring using the PTSD Checklist, and resources for obtaining support.
15958424|NCT03199729|Other|Slip-only training|Subjects in this arm will receive overground, slip specific perturbation training only. The total perturbation training trials received by this group will be 24 but the protocol will consist of a total of 70-75 trials (to match the training length and time of Combined slip and trip training group).
15958425|NCT03199729|Other|Trip-only training|Subjects in this arm consisting of a total of 24 trials of trip specific training delivered in an identical sequence (mixed with non-trip trials) as the Group with slip only training.
15958426|NCT03199729|Other|Combined slip+trip training|Subjects in this arm will receive training consisting of repeated exposure to both slips and trips with a total of 24 slips plus 24 trips to keep the number of trials of each perturbation same as the perturbation specific training groups (slip only and trip only), however, the total dose will be doubled. The total trials walked (perturbed + unperturbed) will be 75.
15958427|NCT03199716|Other|Parent mentors|Parent mentors are to meet up with their assigned intervention group 4 times in 1 year and call the families monthly to document any diabetic complications
15958428|NCT03199703|Device|Baylis transseptal system group|
15958429|NCT03199703|Device|Standard conventional transseptal group|
15958430|NCT03199690|Drug|Dolutegravir|Antiviral (integrase inhibitor)
15958431|NCT03199690|Drug|Rifampicin|Antibiotic
15958432|NCT03199677|Drug|Apatinib|Apatinib is an oral tyrosine kinase inhibitor.
15958433|NCT03199664|Radiation|NB-UVB|NB-UVB given twice weekly for 6 months
15958434|NCT03199664|Combination Product|NB-UVB & Tacrolimus 0.03%|NB-UVB given twice weekly for 6 months and tacrolimus 0.03 % ointment given for twice daily for the first month of treatment and once daily for the rest 5 months of treatment
15958435|NCT03199651|Other|Best Practice|Receive usual care
15958436|NCT03199651|Procedure|Biospecimen Collection|Undergo collection of tumor tissue and blood sample for repository
15958437|NCT03199651|Procedure|Biospecimen Collection|Undergo tumor tissue and blood sample for AGIT/DS
15958438|NCT03199651|Other|Laboratory Biomarker Analysis|Correlative studies
15958439|NCT03199651|Other|Medical Chart Review|Undergo medical record abstraction
15958440|NCT03199651|Other|Quality-of-Life Assessment|Ancillary studies
15958441|NCT03199651|Other|Questionnaire Administration|Ancillary studies
15958442|NCT03199651|Behavioral|Smoking Cessation Intervention|Undergo usual care or NCCN-driven CTC/DS
15958443|NCT03199638|Drug|Glutamine vs. Placebo|oral supplementation with either glutamine or placebo twice daily for 3 months
15958444|NCT03199638|Other|Exercise|short bouts of exercise ('exercise snacks') 3 times daily for 3 months
15958445|NCT03199625|Behavioral|Cognitive therapy|
15958446|NCT03199625|Behavioral|Behavior therapy|
15958447|NCT03199625|Drug|SSRI antidepressants|
15958448|NCT03199612|Drug|Sildenafil|To conduct a randomized placebo controlled study to test the hypothesis that platelet activation and aggregation during ongoing low level hemolysis in outpatients on chronic CF pump support can be reduced by sildenafil.
15958449|NCT03199612|Drug|Placebo Oral Tablet|Negative control to understand the potential changes in platelet activation adn aggregation in comparison to sildenafil.
15958450|NCT03199586|Drug|NP-G2-044|capsule
15958451|NCT03199560|Drug|Tc 99m tilmanocept|lymphatic mapping agent
15958452|NCT03199560|Drug|Tc 99m filtered sulfur colloid|lymphatic mapping agent
15958453|NCT03199547|Drug|Azithromycin|The women will be randomized to receive a single dose of Azithromycin or Placebo
15958454|NCT03199547|Drug|Placebo Oral Tablet|The women will be randomized to receive a single dose of Azithromycin or Placebo
15958455|NCT03199534|Drug|Botulinum toxin A 50u|Subject will receive injection of 50u Botulinum toxin A with local sedation as an office procedure.
15958456|NCT03199534|Drug|Botulinum toxin A 100u|Subject will receive injection of 100u Botulinum toxin A in either the office or while anesthetized.
15958457|NCT03199534|Drug|Botulinum toxin A 150u|Subject will receive injection of 150u Botulinum toxin A while anesthetized.
15958458|NCT03199521|Other|Thrombin generation assays, Thromboelastography (TEG), and Global Thrombosis Test (GTT)|Global Thrombosis Test (GTT): assesses formation of the blood clot and how easily can this be broken down once formed) Thromboelastography (TEG) :assesses the properties of a blood clot and how easily can be broken down Thrombin generation assays: assesses the formation of a blood clot and the potential of thrombolysis via the introduction of different buffer solutions
15958459|NCT03199508|Diagnostic Test|the 3-day voiding diary|The 3-day voiding diary is a medical record which need participants to fill in a table about urine volume for 2 days and 3 nights.
15958460|NCT03199508|Diagnostic Test|the 7-day voiding diary|The 7-day voiding diary is a medical record which need participants to fill in a table about urine volume and drinking water volume for 4 days and 7 nights.
15958461|NCT03199495|Other|electroacupuncture|acupuncture needle with TENS device
15958462|NCT03199482|Drug|Dexamethasone Oral Tablet|single dose of tablet 0.5 mg dexamethasone given to patients before starting of root canal treatment by 30 minutes or placebo
15958463|NCT03199482|Drug|Placebo|Placebo will be administrated 30 minutes before start of root canal treatment
15958464|NCT03199469|Genetic|AT132|AT132 is an AAV8 vector containing a functional copy of the human MTM1 (hMTM1) gene.
15958465|NCT03199456|Device|Zip surgical skin closure device|Zip surgical skin closure device manufactured by ZipLine Medical, Inc. is a CE-marked, non-invasive, single use device that is designated to provide closure of the skin layer for lacerations or surgical incisions.
15958466|NCT03199456|Device|Standard of Care sutures|Standard of Care sutures according to the hospitals current clinical praxis.
15958467|NCT03199443|Diagnostic Test|EMG pelvic floor|EMG activity during tined lead test procedures will be monitored and the response on needle stimulation will be evaluated
15958468|NCT03199430|Dietary Supplement|Epigallocatechin gallate|
15958469|NCT03199430|Dietary Supplement|Placebo|1450mg Corn Flour
15958470|NCT03199417|Drug|Multiprofen|A multimodal topical cream treatment with Ketoprofen, Baclofen, Amitryptiline, and lidocaine in a carrier gel.
15958471|NCT03199417|Other|Placebo|An identically packaged placebo cream
15958472|NCT03199404|Device|TRAP|Mechanical thrombectomy performed with the combination of a stent retriever that is partially re-sheathed and withdrawn under constant aspiration along with the use of a balloon guide catheter for distal flow control during thrombectomy.
15958473|NCT03199391|Device|BioWick SureLock Implant|The BioWick SureLock implant is a device for shoulder and extremity surgery, constructed of Ultra High Molecular Weight Polyethylene Suture. BioWick SureLock is uniquely designed to minimize these risks by avoiding manual tensioning with an inserter mechanism that ensures that the implant is consistently deployed below the cortex.
15958474|NCT03199378|Other|Neuropsychological Testing|Each group will be administered a battery of neuropsychological tests
15958475|NCT03199365|Behavioral|Behavioral Dietary Intervention|Undergo TSSC intervention sessions
15958476|NCT03199365|Behavioral|Behavioral Intervention|Undergo TSSC intervention sessions
15958477|NCT03199352|Other|RYGB hand-sewn|Patients will have the RYGB anastomosis hand-sewn
15958478|NCT03199352|Other|RYGB linear-staple|Patients will have the RYGB anastomosis performed using a linear staple.
15958479|NCT03199339|Drug|TBA-7371|The test product is TBA-7371 25 mg/ml oral suspension formulation and TBA-7371 matching placebo oral suspension.
15958480|NCT03199339|Drug|Placebo|The test product is TBA-7371 25 mg/ml oral suspension formulation and TBA-7371 matching placebo oral suspension.
15958481|NCT03199326|Other|Collaborative Care|CPS caseworkers will explain collaborative care to parents, ask parents to allow communication with an infant's primary care provider, and have willing parents sign a release allowing communication with the infant's provider during the investigation. Caseworkers will make at least two attempts to contact identified providers with parental consent. In the first week, caseworkers will contact the provider, identify the infant, and summarize the child maltreatment concerns. The caseworker will ask whether the provider recognizes any additional strengths or vulnerabilities for the infant. Prior to case closure, caseworkers will provide a summary of investigation findings, disposition, and service referrals including placement changes, safety planning, family preservation, and community resources, with a summary letter delivered to the provider after case closure.
15958482|NCT03199313|Drug|Sutezolid|Sutezolid supplied as tablets and matching placebo for oral administration.
15958483|NCT03199313|Drug|Placebo|Matching Sutezolid placebo
15958484|NCT03199300|Drug|Anthracyclines|Chemotherapy regimen containing anthracyclines.
15958485|NCT03199300|Drug|Trastuzumab|Systemic treatment including trastuzumab.
15958486|NCT03199300|Drug|Cisplatin|Chemotherapy including cisplatin.
15958487|NCT03199300|Drug|Bleomycin|Chemotherapy including bleomycin.
15958488|NCT03199274|Procedure|Yttrium-90 Microsphere Radioembolization|Undergo standard of care Y-90 radioembolization
15958489|NCT03199274|Drug|Perflutren Protein-Type A Microspheres|Given IV.
15958490|NCT03199274|Procedure|Dynamic Contrast-Enhanced Ultrasound Imaging|Undergo CEUS
15958491|NCT03199261|Drug|rE-4 Injection|During the study session, healthy subjects will be receive a subcutaneous single dose of rE-4 Injection 10µg administered 30 minutes prior to the start time of a standard breakfast.
15958492|NCT03199261|Drug|rE-4 Freeze-dried Powder|During the study session, healthy subjects will be receive a subcutaneous single dose of rE-4 Freeze-dried Powder 10µg administered 30 minutes prior to the start time of a standard breakfast.
15958493|NCT03199248|Procedure|Aspiration with percutaneous capsulotomy For digital mucous cysts|The surgical procedure for DMCs was using a 18G needle performing aspiration first and then cutting the stalk tract by the needle tip for capsulotomy. All procedure were done with anesthesia. After operation, we asking patient using dressing to pressure the wound about 10 mins to stop bleeding. Later on, the wound was covering with antimicrobial oint(Neomycin) and simple dressing. Educating patient from water for 24 hr.
15958494|NCT03199235|Device|Lucky Iron Fish|200g iron ingot that is placed in boiling water for 10+ minutes, and then removed. The water is then used to eating and drinking.
15958495|NCT03199235|Other|enhanced standard of care|parents of subjects are provided oral iron supplementation per usual clinical care at clinic and followed for their anemia in addition to study visits
15958496|NCT03199222|Device|Prosthetic smart socket technology with patient prompting|The smart socket technology will send feedback to the user's smartphone with suggestions including the removal or application of prosthetic socks over the residual limb or other volume management strategies to improve fit and comfort.
15958497|NCT03199209|Other|Behavioral, Psychological or Informational Intervention|Receive information about healthy lifestyles
15958498|NCT03199209|Other|Behavioral, Psychological or Informational Intervention|Receive information about healthy homes
15958499|NCT03199209|Behavioral|Patient Visit|Attend study visit with research staff
15958500|NCT03199209|Other|Questionnaire Administration|Ancillary studies
15958501|NCT03199209|Other|Text Message|Receive information about healthy lifestyles
15958502|NCT03199209|Other|Text Message|Receive texts about healthy homes
15958503|NCT03199196|Device|Activity Tracker|"Group 1 - Intervention: Participants given an accelerometer at each visit. Participant wears the accelerometer for 7 days.
~Group 2 - Newsletters: After completing the 16 week visit, participant given an activity tracker."
15958504|NCT03199196|Device|Smartphone Application|"Group 1 - Intervention: Participant given smartphone application baseline visit to track physical activity, connect with participant's partner to share information about participant's physical activity, and provide support to partner to be more physically active.
~Group 2 - Newsletters: After completing the 16 week visit, participant given instruction in the use of a smartphone application."
15958537|NCT03198949|Drug|Afinitor (everolimus)|"Everolimus doses will be 4.5mg/m2 po daily given at first time and then during the 4-week titration period everolimus dose may get adjusted to reach trough concentration of 5 - 15 ng/mL.
~(In order to keep the blind, placebo doses will be also adjusted during core phase based on a random scheme of dose changes.)"
15958505|NCT03199196|Behavioral|Questionnaires|Participants complete questionnaires about feelings, moods, motivation for physical activity, any social support received from others, the neighborhood participant lives in, and other physical activity-related topics. Questionnaires completed 1 time at the beginning of the study, 8 weeks after joining the study, and 16 weeks after beginning the study.The questionnaires should take about 45 minutes to complete.
15958506|NCT03199196|Behavioral|Focus Group|Participants invited to take part in a final focus group. Focus group takes place sometime after the 16-week visit. Focus groups/interviews are audio recorded.
15958507|NCT03199196|Behavioral|Electronic Newsletters|Participant emailed electronic newsletters to read that may help participant be more physically active.
15958508|NCT03199196|Behavioral|Telephone Counseling|Research staff provides telephone counseling to participant and partner biweekly during weeks 1-8 (weeks 1, 3, 5, and 7), and monthly during weeks 9-16 (weeks 11 and 15).
15958509|NCT03199183|Radiation|PET-CT|PET-CT will be proceed on the basis of clinical status and aspiration of individual patient. The imaging results will be analysed by professional radiologists.
15958510|NCT03199183|Other|laboratory biomarker analysis|Screening of potential biomarkers related to Takayasu arteritis and verification tests will be operated.
15958511|NCT03199183|Genetic|genetic sequencing|Genetic sequencing results will be analysed to identify susceptible alleles or single nucleotide polymorphisms of Takayasu arteritis.
15958512|NCT03199170|Drug|Intrathecal morphine|0.5% Hyperbaric bupivacaine 2 ml add morphine 0.2 mg for spinal anesthesia
15958513|NCT03199170|Drug|Bilateral Quadratus Lumborum Block|0.25% Bupivacaine 25 ml each side for quadratus lumborum block without spinal morphine
15958514|NCT03199170|Drug|Intrathecal morphine with bilateral Quadratus Lumborum Block|0.5% Hyperbaric bupivacaine 2 ml add morphine 0.2 mg for spinal anesthesia and 0.25% Bupivacaine 25 ml each side for quadratus lumborum block
15958515|NCT03199157|Drug|Fentanyl transdermal patch|Patients received fentanyl 12 mcg transdermal patch group 8 hours preoperatively and until 24 hours after the surgery
15958516|NCT03199144|Drug|Chemotherapy|3 cycles of Gemzar-Abraxane
15958517|NCT03199144|Radiation|Stereotactic radiotherapy|Stereotactic radiation treatment delivering 30 Gy in 5 fractions over 9 days
15958518|NCT03199144|Procedure|Surgery|Whipple procedure will be the recommended procedure but will be modified according to the initial tumor location
15958519|NCT03199131|Procedure|Right ventricular biopsies|a right ventricular biopsy will be taken intraoperatively during either pulmonary endarterectomy (experimental group) or open cardiac surgery (control group).
15958520|NCT03199118|Procedure|CAF +SCTG|the use of coronally advanced flap (CAF) with sub-epithelial connective tissue graft (SCTG) from the palate to cover gingival recession
15958521|NCT03199118|Other|platelet rich fibrin|in addition to coronally advanced flap and sub-epithelial connective tissue graft, PRF is also used in the surgical procedure to cover gingival recession
15958522|NCT03199105|Other|Preoperative education with image illustrations and/or local tetracaine mucilage|The patients were given preoperative education with image illustrations and/or local tetracaine mucilage to alleviate CRBD during the post-operative period.
15958523|NCT03199092|Behavioral|RRT+sat|RRT is a child-friendly computerized reading training program designed for Italian students with DD aged 8-14 yrs. The main feature of this intervention is the integration of a traditional remediation approach (sublexical treatment) with rhythm processing. Therefore, all reading exercises are characterized by a rhythmic accompaniment with gradually increasing speed. For this study, RRT was delivered in combination with a specific auditory training involving several music games specifically designed for improving auditory processing abilities typically compromised in children with DD.
15958524|NCT03199092|Behavioral|Abilmente|'Abilmente' method is an intervention for DD that comprises several validated treatments resulting in a proposal tailored to meet individual needs and features.
15958525|NCT03199079|Other|Measurement|Measurement of cervix elasticity and length measurements is not an intervention
15958526|NCT03199053|Drug|Dapagliflozin|Tablets, Oral, 5mg , Once daily Tablets, Oral, 10mg, Once daily
15958527|NCT03199053|Drug|Saxagliptin|Tablets, Oral, 2.5mg Once daily Tablets, Oral, 5mg, Once daily
15958528|NCT03199053|Drug|Placebo|Matching placebo to dapagliflozin 5mg and 10 mg/saxagliptin 2.5 mg and 5 mg, Tablets, oral, Once daily
15958529|NCT03199040|Drug|Durvalumab|-Human monoclonal antibody
15958530|NCT03199040|Biological|Neoantigen DNA vaccine|-The vaccine will be given by the TDS-IM system
15958531|NCT03199040|Device|TDS-IM system (Inchor Medical Systems)|-At each vaccination time point, patients will receive two injections at separate sites.
15958532|NCT03199040|Procedure|Peripheral blood draw|-Baseline, following completion of standard of care therapy, Day 1, Day 57, Day 113, Day 159, and 1 year after initiation of neoantigen DNA vaccine therapy
15958533|NCT03199027|Other|Adherence Club|Participants will be referred to an Adherence Club at 4 months post-ART initiation. Adherence club visits occur 2-4 monthly at a community hall near the Community Health Centre (CHC). At routine visits, which last 1-2 hours, community health workers provide health education, weigh patients, ask about symptoms and dispense pre-packed ART. Symptomatic patients are sent back to the ART clinic for clinician assessment. An assigned nurse takes blood tests annually at each club, and then returns on the subsequent visit to perform a clinical assessment and check the results. Patients requiring more follow-up or with high viral loads are referred back to the ART clinic at the CHC by the nurse.
15958534|NCT03199014|Device|deploying the Drug-eluting Stents with a prolonged time|the inflation time was more than 30 seconds when the Drug-eluting Stents deploying.The PROMUS Element Plus Stent or Co-Cr sirolimus-eluting coronary stent system（GuReater）was used in this study
15958535|NCT03199014|Device|deploying the Drug-eluting Stents with a conventional time|the actual inflation time was within 10s determined by interventional cardiologist.The PROMUS Element Plus Stent or Co-Cr sirolimus-eluting coronary stent system（GuReater）was used in this study
15958536|NCT03198975|Diagnostic Test|Magnetic resonance image|Histologically-diagnosed primary HCC after curative hepatectomy. The magnetic resonance image will be imported into the software ,and the radiomic textural features will be automatically extracted by the Analysis-Kit software.The high-throughput extracted features will be then selected and a prediction model will be developed in the training set in which patients were collected from a retrospective study. In this project, an independent validation set will be collected and used to validate the prediction accuracy of the model.
15958538|NCT03198936|Dietary Supplement|Cognizin® SynapsaTM|2 capsules to be taken twice a day with meals with a glassful of water
15958539|NCT03198936|Dietary Supplement|Placebo|2 capsules to be taken twice a day with meals with glassful of water
15958540|NCT03198923|Biological|natural killer and natural killer T cell|The eligible patients are infused with 10 doses of (2-2.5)x10^9 NK and NKT cells in one course of treatment.
15958541|NCT03198884|Drug|Darunavir 800 MG, Norvir 100 MG, Dolutegravir 50 MG|
15958542|NCT03198871|Drug|Acetaminophen Injectable Product|The interventional group will receive 1 gram intravenous acetaminophen at the start of wound closure to be repeated every 6 hours for 48 hours postoperatively
15958543|NCT03198871|Drug|Sodium Chloride 0.9%, Intravenous|The placebo group will be given an intravenous placebo of saline solution at wound closure and repeated every 6 hours for 48 hours postoperatively.
15958544|NCT03198858|Procedure|CartoUnivu™|Ablation with Carto® 3 System and image integration module = IIM, CartoUnivu™
15958545|NCT03198858|Procedure|Ablation with Carto® 3 System|usual Pulmonary vein isolation Ablation with Carto® 3 System only
15958546|NCT03198845|Other|video game|20-min per session for 3 times per week for a 4-week duration
15958547|NCT03198845|Other|exercise|20-min per session for 3 times per week for a 4-week duration
15958548|NCT03198832|Procedure|Non-surgical periodontal treatment|Debridement in a single session in which patients will be anesthetized and receive scaling and root planing with ultrasound equipment .
15958549|NCT03198819|Drug|Local Rifampisin and İnrtravenous cefotaxime|
15958550|NCT03198806|Other|Treadmill aerobic exercise in supine position|The volunteers will be submitted to a cardiovascular rehabilitation session with 40 minutes of treadmill aerobic exercise followed by 60 minutes of recovery at the supine position.
15958551|NCT03198806|Other|Treadmill aerobic exercise and water intake in supine position|The volunteers will be submitted to a cardiovascular rehabilitation session with 40 minutes of treadmill aerobic exercise and water intake followed by 60 minutes of recovery at the supine position.
15958552|NCT03198806|Other|Treadmill aerobic exercise in orthostatic position|The volunteers will be submitted to a cardiovascular rehabilitation session with 40 minutes of treadmill aerobic exercise followed by 10 minutes of recovery at the orthostatic position.
15958553|NCT03198806|Other|Treadmill aerobic exercise and water intake in orthostatic position|The volunteers will be submitted to a cardiovascular rehabilitation session with 40 minutes of treadmill aerobic exercise and water intake followed by 10 minutes of recovery at the orthostatic position.
15958554|NCT03198793|Drug|QGC001|Twice daily (BID) administration of oral (PO) QGC001 (250 mg BID, 500 mg BID, and 500 mg BID + hydrochlorothiazide (HCTZ) 25 mg once daily [QD]) over 8 weeks.
15958555|NCT03198780|Other|Breathing Awareness|Participants will use a pulse-oximeter and biofeedback app to guide them through pursed-lip breathing training.
15958556|NCT03198767|Drug|LIK066|LIK066 50 mg tablets. Open-label, bulk, blister-pack.
15958557|NCT03198767|Dietary Supplement|Carbohydrate 50%|50% carbohydrate in breakfast meal
15958558|NCT03198767|Dietary Supplement|Carbohydrate 25%|25% carbohydrate in breakfast meal
15958559|NCT03198767|Dietary Supplement|Carbohydrate 8%|8% carbohydrate in breakfast meal
15958560|NCT03198767|Dietary Supplement|Carbohydrate 0%|0% carbohydrate in breakfast meal
15958561|NCT03198767|Dietary Supplement|Psyllium|Powder 6 grams
15958562|NCT03198767|Dietary Supplement|Calcium carbonate|Liquid 1 gram (4 mL equivalent sugar free)
15958563|NCT03198754|Device|PEI Experimental Light|Ambient Light Fixture will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
15958564|NCT03198754|Device|Comparison Light|Ambient Light Fixture will turn on automatically and illuminate the hospital room from 7 to 10 AM each morning.
15958565|NCT03198741|Drug|Aspirin + clopidogrel|After randomization(6 months±2 weeks after enrollment),receive aspirin 100mg/d + clopidogrel 75mg/d for an additional 6 months. The above treatments between 6 and 12 months are double-blinded.
15958566|NCT03198741|Drug|Clopidogrel monotherapy|After randomization(6 months±2 weeks after enrollment),receive clopidogrel 75mg/d + placebo (clopidogrel monotherapy group) for an additional 6 months. The above treatments between 6 and 12 months are double-blinded.
15958567|NCT03198741|Drug|Aspirin monotherapy|After randomization(6 months±2 weeks after enrollment),receive aspirin 100mg/d + placebo (aspirin monotherapy group) for an additional 6 months. The above treatments between 6 and 12 months are double-blinded.
15958568|NCT03198728|Drug|SOV2012-F1|oral preparation of testosterone undecanoate (TU)
15958569|NCT03198728|Drug|AndroGel|topical testosterone gel
15958570|NCT03198715|Drug|DS1040b|DS-1040b in solution for intravenous infusion
15958571|NCT03198715|Drug|Placebo|Saline solution for intravenous infusion
15958572|NCT03198702|Drug|Botulinum toxin type A injection|A total of 8UI/kg will be injected in the internal shoulder rotator muscles: 2UI/kg in the sub scapular muscle, 3UI/kg in the pectoralis major muscle and 3UI/kg in the teres major/latissimus dorsi muscle.
15958573|NCT03198702|Other|Sham|The injection is mimed, the procedure is the same as the botulinum toxin injection.
15958574|NCT03198689|Drug|Brentuximab Vedotin|Dose 0.6 mg/kg i.v. will be given every 3 weeks for 16 cycles (48 weeks) in addition to standard of care medications for SSc that may include cyclophosphamide, methotrexate, azathioprine, mycophenylate mofetil (MMF, cellcept) and mycophenolic acid (myfortic).
15958575|NCT03198676|Drug|PrEP-001 6.4 mg|6.4 mg as 4 sprays per nostril (ie total of 8 sprays for a single dose) using Aptar unit dose strength powder (UDSP) device
15958576|NCT03198676|Drug|PrEP-001 6.4 mg|6.4 mg as 2 sprays per nostril (ie total of 4 sprays for a single dose) using Aptar UDSP device
15958577|NCT03198676|Drug|PrEP-001 3.2 mg|3.2 mg as 1 spray per nostril (ie total of 2 sprays for a single dose) using Aptar UDSP device
15958578|NCT03198676|Drug|Placebo|2 sprays per nostril (ie total of 4 sprays for a single dose) using Aptar UDSP device
15958579|NCT03198663|Behavioral|POSSE|Popular-opinion leader
15958580|NCT03198650|Drug|Acalabrutinib|Acalabrutinib
15958581|NCT03198650|Drug|Obinutuzumab|Obinutuzumab
15958582|NCT03198637|Drug|Cisatracurium's monitoring by TOF (train-of-four) WATCH device.|Neuromuscular blockade's monitoring by Cisatracurium thanks to TOF (train-of-four) WATCH device.
15958583|NCT03198637|Drug|clinical assessment|
15958584|NCT03198624|Drug|HTL0018318|Part A single dose Part B five doses
15958586|NCT03198611|Diagnostic Test|Echocardiography|Usual echocardiographic studies in patients suffering septic shock
15958587|NCT03198598|Behavioral|Iyengar Yoga|The patients are going to practice Yoga two times per week during 60 minutes each composed by: 40 minutes of postures, 10 minutes of breathing exercises and 10 minutes of meditation. The proposed Yoga postures will depend on disease severity and will be adapted according to each patient.
15958588|NCT03198598|Behavioral|Yoga app|The patients showing EDSS scores above 6.0 will be divided in two groups of 20. Due to their movements limitations it is not possible to perform a regular Yoga class. In this case they will receive a smartphone application that has an eight-week program including meditation practices, Yoga exercises that can be done in a seated or laid position and daily care tips.
15958589|NCT03198585|Drug|Empagliflozin 10 MG|Capsule, once a day for 90 days
15958590|NCT03198585|Other|Placebo|Capsule, once a day for 90 days
15958591|NCT03198572|Behavioral|Lifestyle intervention|Lifestyle intervention is consisted of diet control and aerobic exercise. calorie restriction: to subtract 500 kcal from daily calorie intake aerobic exercise: medium intensity aerobic exercise for more than 150 min per week with heart rate around 50-70% of the maximal heart rate.
15958592|NCT03198572|Drug|Placebo|placebo tablets 0.5 tid, 30 minutes before each meal, for 48weeks
15958593|NCT03198572|Drug|Berberine|Berberine tablets 0.5 tid, 30 minutes before each meal, for 48weeks
15958594|NCT03198559|Drug|Disulfiram, (National Drug Code) NDC 0378-4141-01|This study will provide open label disulfiram. Participants will take 2 grams (4x500mg tablets) of disulfiram per day for a total of 28 days
15958595|NCT03198559|Drug|Vorinostat, NDC 00006-0568-40|This study will provide open label vorinostat. Participants will take 400mg (4x100mg capsules) of vorinostat per day on days 8, 9, 10 and days 22, 23, 24.
15958596|NCT03198546|Biological|GPC3 and/or TGFβ targeting CAR-T cells|Engineering GPC3 or/and TGFβ targeting CAR combined with/or without IL7/CCL19 and/or scfv against PD1/CTLA4/Tigit secreting vector into T cells with knockdown of PD1/HPK1, which are isolated from patients with advanced HCC, and then transfusing them back the patients.
15958597|NCT03198533|Device|Triathlon PA|Implantation of Knee Prosthesis
15958598|NCT03198533|Device|Triathlon Pressfit|Implantation of Knee Prosthesis
15958599|NCT03198520|Device|Solvay Dental 360™|polymer Removable Partial Denture (RPD)
15958600|NCT03198507|Drug|RHB-105|"The intended dose of RHB-105 (12.5 mg rifabutin, 250 mg amoxicillin, and 10 mg omeprazole capsules) 4 capsules every eight hours, is equivalent to a total daily dose of:
~Rifabutin 150 mg
~Amoxicillin 3000 mg
~Omeprazole 120 mg
~One 50mg Riboflavin tablet to be taken once daily to maintain the blind."
15958601|NCT03198507|Drug|Active Comparator|"The intended dose of the Active Comparator (250 mg amoxicillin, and 10 mg omeprazole capsules) 4 capsules every eight hours, equivalent to a total daily dose of:
~Amoxicillin 3000 mg
~Omeprazole 120 mg
~One 50mg Riboflavin tablet to be taken once daily to maintain the blind."
15958602|NCT03198494|Other|Acoustic 1Hz Stimulation|1Hz acoustic pulses delivered during sleep via headphones
15958603|NCT03198494|Other|Sham Background Noise|Background Noise used as a control
15958604|NCT03198481|Behavioral|Patient-Centered Counseling Video|Patients will watch a patient-centered education video regarding MUS prior to standard pre-operative counseling.
15958605|NCT03198481|Behavioral|Physician Counseling Video|Patients will watch a physician-centered video regarding MUS prior to standard pre-operative counseling.
15958606|NCT03198468|Device|Bronchoscopic Thermal Vapor Ablation|Vapor (steam) is infused into the targeted region for 8 seconds at a precisely controlled flow rate and power
15958607|NCT03198455|Dietary Supplement|Agaricus blazei Murill-based mushroom extract, Andosan™|Dietary Supplement: Agaricus blazei Murill-based mushroom extract, Andosan™
15958608|NCT03198455|Other|Placebo|Drinking water with food coloring and salt
15958609|NCT03198442|Procedure|F-18 FDG breast PET scan|
15958610|NCT03198429|Behavioral|Caring Dads|Caring Dads is a 15-week group intervention program for fathers, with an intensive intake and two additional individual sessions to set and monitor specific, individualized change goals. Major aspects of innovation in the Caring Dads program include: the use of a motivational approach to engage and retain men in intervention; consistent emphasis on the need to end violence against children's mothers alongside of improving fathering; program content addressing accountability for past abuse and a model of collaborative practice with child protection. The Caring Dads program was developed with a specific commitment to remain focused on the safety and well-being needs of children as a primary goal of intervention and with the recognition that children's safety and well-being is integrally connected to that of their mothers.
15958611|NCT03198429|Behavioral|Mothers in Mind|Mothers in Mind uses an attachment and trauma-informed psycho-educational process approach in 12 weekly sessions (10 of which are in group) with mothers. These sessions focus on raising awareness and validation about the experience of violence and the impact it has on mothering. Specifically, MIM increases mothers' awareness of the impact that exposure to family violence/trauma may have had on their infants and themselves as mothers, helps identify and promote positive parenting skills such as sensitivity and responsiveness to infant needs by increasing parental competence, helps promote emotional closeness and decreasing mothers' social isolation, increases mother and infant physical safety, and encourages positive attachment processes.
15958613|NCT03198403|Drug|Bupivacaine-epinephrine|Popliteal plexus block with 10 mL of bupivacaine-epinephrine 5 mg/mL + 5 microgram/mL.
15958614|NCT03198377|Device|TENS: Randomized frequency modulation|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a strong but comfortable sensation, just Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a strong but comfortable sensation, just below motor threshold. Currents parameters are:
~Frequency modulation: randomized pattern (from 80 to 120 Hz) Pulse width 200 microseconds"
15958664|NCT03198000|Drug|F# 13418-148 Eye Drops|ocular clear liquid. Tetrahydrozoline 0.05%; Glycerin 0.40% 1-2 drops will be instilled as instructed over one day
15958615|NCT03198377|Device|TENS: Scan 6/6 of frequency modulation|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a strong but comfortable sensation, just below motor threshold. Currents parameters are:
~Frequency modulation: Scan of frequency from 80 to 120 Hz in 6/6 mode (frequency sweep from 80 Hz to 120 Hz in 6 seconds and from 120 to 80 Hz in 6 secons) Pulse width 200 microseconds"
15958616|NCT03198377|Device|TENS: Fixed frequency|"Transcutaneous application of Conventional TENS current over the course of the superficial radial nerve in the right forearm for a 20 minutes session. The intensity of the current will increase until participants report a strong but comfortable sensation, just below motor threshold. Currents parameters are:
~Fixed frequency at 100 Hz Pulse width 200 microseconds"
15958617|NCT03198377|Device|Sham Stimulation|Electrodes are placed over the course of the superficial radial nerve in the right forearm for a 20 minutes in the same manner as experimental groups, but will be applied a sham electrical stimulation increasing the current intensity of an unconnected channel.
15958618|NCT03198364|Behavioral|Safety and Recovery Therapy|4 session individualized psychoeducation tailored to people with bipolar disorder or schizophrenia targeting coping skills for suicidal thoughts and their determinants.
15958619|NCT03198364|Behavioral|Mobile Augmentation|Though a smartphone device, participants receive 12 weeks of personalized prompts derived from content produced in individual START sessions to increase transfer of skills to day to day life
15958620|NCT03198351|Drug|Teriflunomide (HMR1726)|"Pharmaceutical form: tablet
~Route of administration: oral"
15958621|NCT03198338|Drug|0.25% Bupivacaine, 0.5mL/kg|Ultrasound guided TAP block using 0.25% Bupivacaine, 0.5ml/kg
15958622|NCT03198338|Drug|Normal Saline|0.9% Normal Saline
15958623|NCT03198338|Device|Ultrasound|Ultrasound guided TAP block
15958624|NCT03198325|Other|Stop of ART|Patients willing to stop antiretroviral therapy will stop ART.The occurrence of two consecutive HIV-1 RNA values >50 copies/mL or the occurrence of stage B or C AIDS-defining events will be criteria for ART resumption or any serious non-AIDS clinical event at least potentially related to treatment interruption.
15958625|NCT03198312|Device|CathiportTM|fully implanted
15958626|NCT03198312|Device|Implant Port|fully implanted
15958627|NCT03198299|Device|MEI BIN insoles|wearing insoles for 12 weeks
15958628|NCT03198286|Other|Informational Intervention|Receive treatment summary and survivor care plan
15958629|NCT03198273|Other|Clinical pilates exercises|servical, lumbal, pelvic muscles
15958630|NCT03198273|Other|physiotherapy program|hot-pack will apply for 20 minutes. Convansionel TENS will apply on the lumbar regions of the cases of the control group paravertebrally with
15958631|NCT03198260|Other|Fascial manipulation|Deep frictional massage
15958632|NCT03198247|Other|Usual care|"The biomedical education session will be imparted 2 weeks before surgery by the preoperative nurse and a physiotherapist. It will have a duration of 2 hours and it is designed for a group of 5 subjects.
~The hospital rehabilitation starts 6 hours after surgery, and it is based in early wandering stimulation, articular mobility exercises and isometric exercises."
15958633|NCT03198247|Other|PNE + CST|The PNE and CST program will be divided in 3 individual sessions.
15958634|NCT03198234|Biological|T-allo10|The T-allo10 drug product consists of donor derived, host (patient) alloantigen hyporesponsive (anergic) CD4+ (cluster of differentiation 4) cells containing Type 1 regulatory T (Tr1) cells induced in vitro in the presence of IL-10 (interleukin-10), which are also defined as IL-10 anergized T cells. T-allo10 cell infusion is being developed to prevent acute Graft-versus-Host Disease (GvHD) and induce graft tolerance in patients with hematologic malignancies receiving mismatched related and unrelated unmanipulated hematopoietic stem cell transplant (HSCT).
15958635|NCT03198221|Drug|Golytely|bowel preparation
15958636|NCT03198221|Drug|Clenpiq|bowel preparation
15958637|NCT03198208|Drug|Fentanyl dose administration|
15958638|NCT03198195|Procedure|cyclophosphamide|on days +3，+4,using cyclophosphamide 50mg/kg
15958639|NCT03198182|Drug|Placebo|Specified dose on specified days
15958640|NCT03198182|Drug|BMS-986036|Specified dose on specified days
15958641|NCT03198169|Device|Atteris Antimicrobial Skin and Wound Cleanser|Wounds will be cleansed with either the experimental wound cleanser or a placebo and will then be covered with standard of care wound dressings.
15958642|NCT03198169|Device|Atteris Antimicrobial Barrier Film Dressing|Wounds will be covered with either the experimental barrier film dressing or a placebo and will then be covered with standard of care wound dressings.
15958645|NCT03198143|Drug|Ghrelin|Subjects will receive a subcutaneous injection of synthetic acyl ghrelin (12 µg/kg) at the start of the study.
15958646|NCT03198143|Drug|Saline|Subjects will receive a subcutaneous injection of saline (0.9%) at the start of the study.
15958647|NCT03198130|Drug|REGN2810|Intravenous (IV) use
15958648|NCT03198117|Drug|Huaier Granule|a Chinese traditional medicine
15958649|NCT03198117|Other|placebo|placebo
15958650|NCT03198104|Device|MRI|
15958651|NCT03198091|Drug|Dun Ye Guan Xin Ning|Dun Ye Guan Xin Ning tablet 320 mg orally every time and 3 times per day for 6 months.
15958655|NCT03198065|Procedure|Hand-made glove setting|The patients receive Hand-made glove setting for single-incision laparoscopic appendectomy
15958656|NCT03198065|Procedure|Commercialized single-incision multiport setting|The patients receive commercialized single-incision multiport setting for single-incision laparoscopic appendectomy
15958657|NCT03198052|Biological|CAR-T cells targeting HER2, Mesothelin, PSCA, MUC1, Lewis-Y, GPC3, AXL, EGFR, Claudin18.2, or B7-H3|CAR-T cells injection: (1-10×10e6/kg CAR-T for each treatment; 3 or more cycles.
15958658|NCT03198039|Behavioral|Meditation|Isha Kriya (IK) meditation approximately 12 minutes, twice a day
15958665|NCT03198000|Drug|F#13418-158 Eye Drops|ocular clear liquid Tetrahydrozoline 0.05%; Glycerin 0.20%, Hypromellose 0.2%, Polyethylene glycol 400 1.0% 1-2 drops will be instilled as instructed over one day
15958666|NCT03198000|Drug|F# PF-004390 Eye Drops|Ocular clear liquid Tetrahydrozoline 0.05%; 1-2 drops will be instilled as instructed over one day
15958667|NCT03197987|Device|Endocuff|Endocuff-assisted colonoscopy
15958668|NCT03197987|Device|cap|Cap-assisted colonoscopy
15958669|NCT03197974|Behavioral|Mindfulness for Bipolar|Brief online self-management program with email coaching support
15958670|NCT03197974|Behavioral|Psychoeducation for Bipolar|Brief online self-management program with email coaching support
15958671|NCT03197961|Combination Product|tenofovir/emtricitabine|At the enrollment visit, participants will be given a 14-day supply of tenofovir/emtricitabine 200mg/300mg to take once daily for 14 days. Drug concentrations will be measured as outlined in the outcomes section at the end of the two week period. The tenofovir/emtricitabine 200mg/300mg course will be repeated approximately 2 to 6 weeks later to allow washout of tenofovir/emtricitabine.
15958672|NCT03197961|Drug|DMPA|After completion of the first 14 day course of tenofovir/emtricitabine depot medroxyprogesterone acetate 150 mg will be administered as intramuscular injection.
15958673|NCT03197948|Other|Internet-Based Intervention|Complete questionnaire via a smartphone application
15958674|NCT03197935|Drug|Atezolizumab (MPDL3280A), an engineered anti-PDL1 antibody|Atezolizumab was administered as per schedule described in respective arm.
15958675|NCT03197935|Drug|Placebo|Placebo matched to atezolizumab was administered as per schedule described in respective arm.
15958676|NCT03197935|Drug|Nab-paclitaxel|Nab-paclitaxel was administered as per schedule described in the arms.
15958677|NCT03197935|Drug|Doxorubicin|Doxorubicin was administered as per schedule described in the arms.
15958678|NCT03197935|Drug|Cyclophosphamide|Cyclophosphamide was administered as per schedule described in the arms.
15958679|NCT03197935|Drug|Filgrastim|Filgrastim was administered according to local prescribing information as determined by the Investigator for 4 doses after completion of initial 12 weeks.
15958680|NCT03197935|Drug|Pegfilgrastim|Pegfilgrastim was administered according to local prescribing information as determined by the Investigator for 4 doses after completion of initial 12 weeks.
15958681|NCT03197922|Combination Product|MIE Treatment|"Appointments consist of a series of sitting routines (i.e., sits). Each sit consists of 10 min on the toilet, followed by 1 min of standing, then repeating the 10 min on the toilet 1 min off, for 30 cumulative minutes of sitting. The first sit occurs prior to the administration of any medication providing an opportunity for an independent continent bowel movement. If no continent bowel movement occurs, trained staff administer a dose of a liquid glycerin suppository, immediately followed by another sit to ensure any resulting bowel movement is continent. Glycerin suppositories are replaced by bisacodyl if 2 days pass without a continent bowel movement using the liquid glycerin suppository. Behavioral intervention consists of potent positive reinforcers when a continent bowel movement occurs. As independent continent bowel movements begin to occur, the need for the medical regimen diminishes, and is gradually faded out entirely."
15958682|NCT03197909|Other|Determination of pro-inflammatory plasma factors|Determination of pro-inflammatory plasma factors at COPD patients aged from 35 to 85 years old and Healthy subjects aged from 35 to 85 years old
15958683|NCT03197896|Other|Educational Intervention|Review prostate cancer information
15958684|NCT03197883|Other|Test Product|Restoring lipid balm
15958685|NCT03197883|Other|Cleanser|Moisturizing facial cleanser
15958686|NCT03197883|Other|Sunscreen|SPF (Sun Protection Factor) 50 sunscreen
15958687|NCT03197870|Drug|AKB-9778|Subcutaneous AKB-9778 15mg
15958688|NCT03197870|Drug|Placebo|Subcutaneous Placebo
15958689|NCT03197857|Behavioral|Physical activity program : aquabike|The aim of this project is to investigate in obese patients the changes induced by bariatric surgery on the various components of the physical condition and their postoperative evolution following an intervention combining a physical activity program (aquabike vs bicycle) with or without protein supplementation.
15958690|NCT03197857|Behavioral|Physical activity program : bicycle|The aim of this project is to investigate in obese patients the changes induced by bariatric surgery on the various components of the physical condition and their postoperative evolution following an intervention combining a physical activity program (aquabike vs bicycle) with or without protein supplementation.
15958691|NCT03197857|Behavioral|Physical activity program : with protein supplementation|The aim of this project is to investigate in obese patients the changes induced by bariatric surgery on the various components of the physical condition and their postoperative evolution following an intervention combining a physical activity program (aquabike vs bicycle) with or without protein supplementation
15958692|NCT03197857|Behavioral|Physical activity program : without protein supplementation|The aim of this project is to investigate in obese patients the changes induced by bariatric surgery on the various components of the physical condition and their postoperative evolution following an intervention combining a physical activity program (aquabike vs bicycle) with or without protein supplementation
15958693|NCT03197818|Drug|CHF 5993 100/6/12.5 µg|Fixed combination of extrafine beclometasone dipropionate 100 µg plus formoterol fumarate 6 µg plus glycopyrronium bromide 12.5 µg / metered dose
15958694|NCT03197818|Drug|160 µg budesonide + 4.5 µg formoterol fumarate|Fixed combination of budesonide 160 µg plus formoterol fumarate 4.5 µg
15958695|NCT03197805|Diagnostic Test|PAM 50 test|Patients with an equivocal-HER2 breast cancer (IHC Score 2 and equivocal ISH defined as HER2/Chr17 ratio <2 and 4 ≤HER2 gene number copy < 6) will be eligible for RNA genomic test (PAM 50 test). The use of genomic test could help the oncologist to define the better therapeutic decision in a HER2 equivocal population.
15958696|NCT03197792|Other|All patients|"TEE is performed before cardiopulmonary bypass (before the opening of the pericardium, if possible) and immediately after weaning from cardiopulmonary bypass and optimization of the hemodynamic status by the attending anesthesiologist. A detailed ultrasound examination including portal vein pulsatility, splenic vein pulsatility, right and left ventricular global longitudinal strain and right and left systolic and diastolic function is recorded. A measure of portal vein pulsatility using TTE is also recorded before the onset of general anesthesia and on the morning of the 7th postoperative day.
~On the 7th postoperative day, the investigators will evaluate for the presence of the primary outcome, POD + death."
15958697|NCT03197779|Drug|BMS-962212|Intravenous Infusion administration over 2 hours or 5 days
15958698|NCT03197779|Drug|Aspirin|Oral administration
15958699|NCT03197779|Other|Placebo|Oral administration
15958700|NCT03197766|Drug|BMN 111|Subcutaneous injection of 15 μg/kg of BMN 111 daily
15958701|NCT03197766|Drug|Placebo|Subcutaneous injection of 15 μg/kg of placebo daily
15958702|NCT03197753|Device|Laryngeal mask airway|Laryngeal mask airway
15958703|NCT03197753|Device|Nasotracheal intubation|Nasotracheal intubation
15958704|NCT03197740|Drug|Donepezil patch|Treatment
15958705|NCT03197740|Drug|aricept Tab|Comparator
15958706|NCT03197727|Diagnostic Test|GC Saliva-Check BUFFER|Evaluating the saliva flow rate, saliva pH and saliva buffering capacity
15958707|NCT03197714|Drug|OPB-111077|"Two dose schemas will be employed:
~Level 1: 200 mg daily
~Level 2: 250 mg daily"
15958708|NCT03197688|Other|Notapplicable|Not applicable as non-interventional study
15958709|NCT03197675|Other|Acupuncture|Participants within the acupuncture treatment group will receive traditional body acupuncture with electrical stimulation for 30 minutes three times a week, additionally participants will also receive auricular acupuncture once a week with the needles retained in both ears for seven days and replaced the following week, for a total of eight weeks (24 treatments of conventional acupuncture and 8 treatments of auricular acupuncture). Relative pain levels will be measured via the NRS by a member of the research staff before and after each treatment. All participants will then be reevaluated with the described assessment tools at three months and again at six months. Acupuncturists will not participate in the three and six month evaluations of subjects.
15958710|NCT03197662|Drug|Intranasal Oxytocin (IN-OXT)|Each subject will receive a dose of 16 IU QD, and will be instructed to inhale 2 puffs per nostril every day (4 IU each). If needed, treatment will be titrated due to side effects or non-response.
15958711|NCT03197662|Drug|Matched Placebo|Each subject will receive a dose of 16 IU QD, and will be instructed to inhale 2 puffs per nostril every day (4 IU each). If needed, treatment will be titrated due to side effects or non-response.
15958712|NCT03197649|Procedure|Laser phototherapy treatment|Laser phototherapy treatment administered in OR
15958713|NCT03197636|Drug|Pembrolizumab|Pembrolizumab is already approved for treatment of malignant melanoma in advanced stages. We will investigate if sPD-1 or vitamin D status is changed in patients receiving pembrolizumab.
15958714|NCT03197623|Drug|LLP2A-ALENDRONATE|A small molecule, LLP2A-Ale that directs endogenous mesenchymal stem cells (MSCs), the cells that have the potential to grow bone tissue, to the bone surface to form new bone. Single administration of LLP2A-Ale given intravenously over 120 minutes.
15958715|NCT03197623|Drug|Placebo|Placebo, one time single administration given intravenously over 120 minutes.
15958716|NCT03197610|Procedure|enamel matrix derivatives|enamel matrix derivatives and subepithelial connective tissue grafts
15958717|NCT03197597|Other|Strain isolation from the nasopharynx|B. pertussis strains has been collected from the nasopharynx of the patients during the clinical visit
15958718|NCT03197584|Biological|Avelumab|Fully human anti-PD-L1 IgG1 lambda monoclonal antibody
15958719|NCT03197584|Biological|Bevacizumab|Recombinant human anti-VEGF IgG1 monoclonal antibody
15958720|NCT03197584|Drug|Capecitabine|5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine
15958721|NCT03197584|Drug|Cyclophosphamide|2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
15958722|NCT03197584|Drug|5-fluorouracil|5-fluoro-2,4 (1H,3H)-pyrimidinedione
15958723|NCT03197584|Drug|Fulvestrant|7-alpha-[9-(4,4,5,5,5-pentafluoropentylsulphinyl) nonyl]estra-1,3,5-(10)- triene-3,17-beta-diol
15958724|NCT03197584|Drug|Leucovorin|Calcium N-[p-[[[(6RS)-2-amino-5-formyl-5,6,7,8-tetrahydro-4-hydroxy-6-pteridinyl]methyl]amino]benzoyl]-L-glutamate (1:1)
15958725|NCT03197584|Drug|Paclitaxel|5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine
15958726|NCT03197584|Drug|omega-3 acid ethyl esters|omega-3 acid ethyl esters
15958727|NCT03197584|Drug|Oxaliplatin|cis-[(1 R,2 R)-1,2-cyclohexanediamine-N,N'] [oxalato(2-)- O,O'] platinum
15958728|NCT03197584|Radiation|Stereotactic Body Radiation Therapy|Stereotactic Body Radiation Therapy (SBRT)
15958729|NCT03197584|Biological|ALT-803|Recombinant human super agonist IL-15 complex
15958730|NCT03197584|Biological|ETBX-021|Ad5 [E1-, E2b-]-HER2 vaccine
15958731|NCT03197584|Biological|ETBX-051|Ad5 [E1-, E2b-]-Brachyury vaccine
15958732|NCT03197584|Biological|ETBX-061|Ad5 [E1-, E2b-]-MUC1 vaccine
15958733|NCT03197584|Biological|GI-4000|Heat-killed S. cerevisiae yeast expressing the mutated RAS oncoproteins
15958734|NCT03197584|Biological|GI-6301|Heat-killed S. cerevisiae yeast expressing the human Brachyury (hBrachyury) oncoprotein
15958735|NCT03197584|Biological|haNK®|NK-92 [CD16.158V, ER IL-2]
15958736|NCT03197571|Biological|avelumab|Fully human anti-PD-L1 IgG1 lambda monoclonal antibody
15958737|NCT03197571|Biological|bevacizumab|Recombinant human anti-vascular endothelial growth factor (VEGF) IgG1 monoclonal antibody
15958738|NCT03197571|Drug|capecitabine|5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine
15958739|NCT03197571|Drug|cisplatin|(SP-4-2)-diamminedichloroplatinum(II)
15958740|NCT03197571|Drug|cyclophosphamide|2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
15958741|NCT03197571|Drug|5Fluorouracil (5-FU)|5-fluoro-2,4 (1H,3H)-pyrimidinedione
15958742|NCT03197571|Drug|fulvestrant|7-alpha-[9-(4,4,5,5,5-pentafluoropentylsulphinyl) nonyl]estra-1,3,5-(10)- triene-3,17-beta-diol
15958743|NCT03197571|Drug|leucovorin|Calcium N-[p-[[[(6RS)-2-amino-5-formyl-5,6,7,8-tetrahydro-4-hydroxy-6-pteridinyl]methyl]amino]benzoyl]-L-glutamate (1:1)
15958744|NCT03197571|Drug|nab-paclitaxel|5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine
15958745|NCT03197571|Drug|Lovaza|Omega-3-acid ethyl esters
15958746|NCT03197571|Radiation|Stereotactic Body Radiation Therapy|(SBRT)
15958747|NCT03197571|Biological|ALT-803|recombinant human super agonist interleukin-15 (IL-15) complex [also known as IL-15N72D:IL-15RαSu/IgG1 Fc complex]
15958748|NCT03197571|Biological|ETBX-011|adenovirus serotype-5 [Ad5] [E1-, E2b-]-carcinoembryonic antigen [CEA] vaccine
15958749|NCT03197571|Biological|ETBX-021|Ad5 [E1-, E2b-]-human epidermal growth factor receptor 2 [HER2] vaccine
15958750|NCT03197571|Biological|ETBX-051|Ad5 [E1-, E2b-]-Brachyury vaccine
15958751|NCT03197571|Biological|ETBX-061|Ad5 [E1-, E2b-]-mucin 1 [MUC1] vaccine
15958752|NCT03197571|Biological|GI-4000|RAS yeast vaccine
15958753|NCT03197571|Biological|GI-6207|CEA yeast vaccine
15958754|NCT03197571|Biological|GI-6301|Brachyury yeast vaccine
15958755|NCT03197571|Biological|haNK|NK-92 [CD16.158V, ER IL-2], Suspension for Intravenous [IV] Infusion (haNK™ for Infusion)
15958756|NCT03197558|Combination Product|Tymbion Iontophoresis and Tube Delivery System (TDS)|Subjects will receive active Tymbion iontophoresis and tube insertion using the Tube Delivery System in all ears indicated for tube placement.
15958757|NCT03197519|Behavioral|TCApp|During these 12 weeks, in addition to TAU, the patient from the experimental group should use TCApp at least once a day, completing at least one self-record daily and/or contacting his/her therapist via chat when needed. The therapist responsible for the online monitoring should, at least once a week, connect to the online platform and perform the following actions: follow the patient's daily self-records, generate personalized reports or graphs and communicate with him/her via chat. After a 12-week period, patients from the experimental group and their therapists will stop using the TCApp application (they will be discharged).
15958758|NCT03197519|Behavioral|TAU|The TAU control group will receive treatment as usual, that is to say, the standard face-to-face CBT, offered by the different ED units in Spain.
15958759|NCT03197506|Radiation|External Beam Radiation Therapy|Undergo external beam radiation therapy
15958760|NCT03197506|Other|Laboratory Biomarker Analysis|Correlative studies
15958761|NCT03197506|Biological|Pembrolizumab|Given IV
15958762|NCT03197506|Radiation|Radiation Therapy|Undergo radiation therapy
15958763|NCT03197506|Drug|Temozolomide|Given PO
15958764|NCT03197506|Procedure|Therapeutic Conventional Surgery|Undergo surgery
15958765|NCT03197493|Drug|carbidopa-levodopa 25-100 mg|High Dose: daily oral administration 2 tablets TID Intermediate Dose: daily oral administration 1 tablet TID
15958766|NCT03197480|Drug|Aflibercept Injection [Eylea]|All subjects will receive 4 monthly intravitreal injections of aflibercept
15958767|NCT03197467|Drug|Pembrolizumab|Pembrolizumab at fixed dose: 200 mg q3w i.v. for 2 cycles
15958768|NCT03197454|Other|Computerized Plasticity-Based Adaptive Cognitive Training|Forty-two minutes of training on computerized exercises that targets processing speed, memory and attention.
15958769|NCT03197454|Other|Commercially available computerized training|Forty-two minutes of training on computerized, casual video games.
15958770|NCT03197441|Other|Platelet-rich plasma|Intraoperative platelet-rich plasma injection during arthroscopic knee surgery
15958771|NCT03197428|Other|Platelet-rich plasma|Platelet-rich plasma gel applied during the modified Broström-Gould procedure for reconstructing lateral ligament
15958772|NCT03197428|Other|Control|Whole blood applied during the modified Broström-Gould procedure for reconstructing lateral ligament
15958773|NCT03197415|Other|Platelet-rich plasma|intradiscal injection of plasma-rich platelet
15958774|NCT03197402|Dietary Supplement|Leucine-enriched protein gel delivery system|Leucine enriched
15958775|NCT03197402|Dietary Supplement|Milk protein gel delivery system|Non-leucine enriched
15958776|NCT03197389|Drug|Pembrolizumab|Biological: humanized anti-PD-1 monoclonal antibody humanized anti-PD-1 monoclonal antibody is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2.
15958777|NCT03197376|Biological|Pneumosil|10-Valent Pneumococcal Conjugate Vaccine
15958778|NCT03197376|Biological|Synflorix|Pneumococcal conjugate vaccine (Non-Typeable Haemophilus influenzae (NTHi) protein D, diphtheria or tetanus toxoid conjugates) adsorbed
15958779|NCT03197363|Other|Discovering novel risk factors.|The study protocol includes multiple imaging and functional investigations (including heart, carotid, thyroid, liver ultrasound, fundoscopy, plethysmography, pulse wave velocity, ankle-brachial index, ECG, body composition measured by bioimpedance and dual energy x-ray absorptiometry, anthropometric assessment, rhinometry, hand grip test, oral glucose tolerance test, advance glycation end-products measurement, voice recording. There will be a detailed and verified questionnaires concerning various activities of the subject: physical activity, depression, sino-nasal symptoms, prostate hypertrophy, female urinary tract symptoms, quality of life, smoking and drinking addiction, hirsutism.
15958780|NCT03197350|Diagnostic Test|cMR|cardiac MRI done to complete the diagnosis
15958781|NCT03197350|Biological|biomarker|Biomarker correlation with cMR parameters Prognostic information
15958782|NCT03197337|Procedure|Pressure-test|Pressure will be applied to the posterior fornix using a speculum.
15958783|NCT03197324|Drug|Bexagliflozin|Bexagliflozin tablets, 20 mg
15958784|NCT03197324|Drug|Digoxin|2 0.25 mg Digoxin tablets (total dose 0.5 mg digoxin)
15958785|NCT03197311|Other|Mobile app|A customized mobile application will be developed and downloaded to subjects; smartphones to monitor postoperative analgesic consumption, and disposal; pain control and patient satisfaction. The mobile app will provide notifications for medications and select education links on the prescribed analgesics. Subjects will receive reminders to take medications as directed. Subjects will be able to monitor and report their pain during the first week after surgery.
15958786|NCT03197298|Drug|Clopidogrel|
15958787|NCT03197298|Drug|Ticagrelor|
15958788|NCT03197285|Other|EYE-CERVICAL RE-EDUCATION PROGRAM|"Subjects received a total of ten sessions on alternate days.
~This includes a total of 10 exercises that has proprioceptive reprogramming in the cervical area with the following phases:
~To stimulate ocular mobility without including the cervical movement. The patient was placed in the supine position and the physiotherapist seated, at the height of the head.
~To exercise cervical mobility with restricted eye movement. The patient is placed on a rotating stool. The ocular mobility is excluded with opaque glasses that allowed exclusively the foveal vision
~Finally we stimulate eye and neck movement coordination. The patient continued to sit on the stool, this time without the glasses."
15958861|NCT03196817|Device|Wrist splinting|Splinting only at night to maintain the wrist positioned in 15 degrees of extensionin.
15958862|NCT03196804|Drug|LC28-0126|LC28-0126
15958863|NCT03196804|Drug|Placebo|Placebo
15958789|NCT03197285|Other|Combined Physiotherapy Protocol|Thermotherapy (70 w continuous microwave for 10 minutes), therapeutic massage (surface rubbing for 5 minutes, 10 minutes of compression and kneading massage and 2 minutes of final surface friction), application of analgesic currents (TENS, by self-adhesive silicone electrodes 4x4 cm, symmetrical biphasic rectangular current, 200 µs width pulse, a frequency of 1 Hz for 10 minutes. The patient should notice a slight vibration, without it being painful).
15958790|NCT03197272|Procedure|PiXL|Phototherapeutic intrastromal corneal collagen cross-linking (PiXL) performed in a high-oxygen environment without corneal epithelial debridement, for treatment of mild myopia.
15958791|NCT03197246|Device|IVECG|Monitoring IVECG signals for verification for exact tip placement during the actual insertion of the PICC. When the p-wave amplitude increases the PICC-tip is in the superior vena cava. When max positive amplitude, the PICC-tip is by definition at the cavo atriale junction, and thereby in correct position.
15958792|NCT03197246|Device|Chest X-ray|Standard method; PICC confirmed by chest X-ray after the insertion (postoperatively)
15958793|NCT03197233|Other|Maternal vitamin A and D intake during pregnancy|Dietary exposures during pregnancy and infant supplement use were assessed from maternal questionnaire report
15958794|NCT03197220|Other|fish|300 gr/week fish
15958795|NCT03197220|Other|walnut|18 walnut per week
15958796|NCT03197220|Other|fish-walnut|150 gr fish and 9 walnut per week
15958797|NCT03197207|Procedure|"Dragon and Tiger warring in lifting and thrusting"|"Tight press slow insert in each acupoint through the superficial,intermediate, deep layer, then tight lifting slow withdraw needle through the deep, intermediate, superficial layer . Two acupoints (GB34, GB39) are manipulation in the process three times each during one minute, then let patients lift shoulder up and down for three times, then draw out the needle 20 minutes later."
15958798|NCT03197207|Procedure|"Dragon and Tiger warring in twisting-rotating"|When needle insert in each acupoint through the superficial,intermediate, deep layer, within each layer twisting thumb forward nine times, then twisting backward six times. Two acupoints (GB34, GB39) are manipulation in the process during one minute, then let patients lift shoulder up and down for three times, then draw out the needle 20 minutes later.
15958799|NCT03197194|Drug|Alteplase|alteplase administered as an intravenous infusion (0.9 mg/kg; maximum dose 90 mg): 10% given as an IV bolus, followed immediately by the remaining given as an IV infusion over 1 hour.
15958800|NCT03197194|Drug|acetylsalicylic acid|one tablet of aspirin 300 mg
15958801|NCT03197194|Drug|Placebo Oral Tablet|One placebo oral tablet which doesn't contain the active ingredient acetyl salicylic acid
15958802|NCT03197194|Drug|placebo IV|IV saline solution (0.9 %):10 mL in a syringe administered over 1 minute, followed by 50 mL as an infusion over 1 hour
15958803|NCT03197181|Device|transcranial direct current stimulation|Participants receive anodal or sham transcranial direct current stimulation while performing effort-based decision tasks.
15958804|NCT03197168|Behavioral|Intervention to reduce self-stigma among people with mental illness|"This is a 10-session group intervention (held once a week), each lasting approximately 90 minutes, taking place where the participants receive mental health treatment.
~The intervention is informed by the following key areas: (1) recovery perspective of mental health and severe mental disorders; (2) constructivist epistemology approach to learning, using cases and users' experiences; and (3) psychotherapeutic and collective narrative practices, to address internalized problems and challenges shared among the group members, respectively."
15958805|NCT03197168|Behavioral|Control|Generally, each community mental health center in Chile includes two full-time psychologists, a full-time social worker and half-time occupational therapist, nurse, and psychiatrist. This team mainly offers psychiatric medication, psychotherapy, and psycho-education for users and relatives. They do not offer any specific intervention to tackle stigma among providers.
15958806|NCT03197155|Drug|Direct Acting Antivirals against hepatitis C virus infection|The cohort includes cirrhotic patients infected with HCV and successfully treated for their first history of hepatocellular carcinoma. Some of these patients were treated with direct-acting antivirals for their HCV infection while the others did not receive any direct-acting antivirals treatment during the follow-up period.
15958807|NCT03197129|Other|sensory adapted waiting room|The SADE waiting room: a small waiting room (2.5mx2.5m) inside the clinic with 6 seats. All ceiling fluorescent lighting is removed. The adapted lighting consisted of slow-moving, repetitive visual color effects created by a projector, and a lighting column that children can touch and climb on. Auditory stimuli include rhythmic music, which is heard via loudspeakers.
15958808|NCT03197129|Other|traditional waiting room|The traditional waiting room: a waiting area outside the clinic with ten seats in one row faces the reception desk in an area of 15 square meters. The area is air-conditioned, moderately well-lit, without posters or paintings on the walls, and no reading material.
15958809|NCT03197116|Other|Telephone reminder|Interactive telephone reminder by a trained layperson with a standard script to remind return to the center for taking fecal tubes for CRC screening
15958810|NCT03197116|Other|No other|No additional reminder will be offered
15958811|NCT03197103|Drug|N-Acetylcysteine (NAC)|For more information read Experimental Arm description
15958813|NCT03197077|Procedure|blood sampling|comparison between corifollitropin alfa and follitropin beta in IVM cycles
15958814|NCT03197077|Procedure|transvaginal ultrasound scanning|comparison between corifollitropin alfa and follitropin beta in IVM cycles
15958815|NCT03197077|Procedure|oocyte retrieval for IVM|comparison between corifollitropin alfa and follitropin beta in IVM cycles
15958816|NCT03197077|Drug|Corifollitropin Alfa|Single injection of 100 micrograms of corifollitropin alfa
15958817|NCT03197077|Drug|Follitropin beta|Daily injection (three days) of follitropin beta
15958818|NCT03197077|Drug|oral contraceptive pill pretreatment (Marvelon)|Daily administration of the oral contraceptive pill (Marvelon) for 21 days. Administration of the combined oral contraceptive pill will start after a blood test that demonstrates basal E2 levels and a negative serum hCG level.
15958819|NCT03197064|Drug|Fosaprepitant 150 mg|Antiemetic used to prevent nausea and vomiting after general anesthesia.
15958943|NCT03196297|Drug|Concizumab|0.15 mg/kg (with potential stepwise dose administration to 0.25 mg/kg) administered daily s.c (subcutaneously, under the skin). Treatment duration is 24 weeks in the main phase, and 52 weeks in the extension phase
15958820|NCT03197038|Behavioral|Partially supervised home-based walking exercise|Participants will be asked to exercise at home by walking at a moderate intensity. Each participant will receive an exercise prescription. Participants will receive a heart rate monitor. The heart rate monitors will be used to achieve a desired exercise intensity and to monitor adherence levels. The participants will receive biweekly to weekly phone calls, and monthly in person meetings will be used to address any barriers, provide encouragement, and progress the exercise.
15958821|NCT03197038|Behavioral|Control|Participants will be asked to exercise at home by walking at a moderate intensity. The participants will receive biweekly phone calls, but will not receive a heart rate monitor, individual exercise prescription, or meet with the investigators monthly.
15958822|NCT03197025|Drug|Aldesleukin|Aldesleukin 720,000 IU/kg (based on total body weight) intravenous (IV) infused over 15 minutes approximately every 12 hours for a maximum of two doses.
15958823|NCT03197025|Biological|E6 T Cell Receptor (TCR)|On day 0, the E6 TCR cells will be administered one time, intravenously over 20 to 30 minutes
15958824|NCT03197012|Drug|90Y-DOTA-TOC|Starting 30 minutes prior to the administration of 90Y-DOTA-TOC, amino acid solution will be administered via IV, and will continue through the PRRT procedure. An angiographic catheter will be inserted under fluoroscopic guidance to the appropriate location in the hepatic artery. 90Y-DOTA-TOC will be administered via the hepatic arterial catheter.
15958825|NCT03197012|Drug|68Ga-DOTA-TOC|In the sub-study, 10 patients will receive 68Ga-DOTA-TOC concurrent with the 90Y-DOTA-TOC dose and 90 minutes after treatment, these patients will be imaged using a PET/CT. The following day, patients enrolled in the sub-study will undergo a PET/MRI.
15958826|NCT03196999|Behavioral|Personalized Attention Bias Training|This self-help program will aim to reduce neurobiological threat sensitivity with the ultimate goal of developing a low-cost and highly scalable self-help tool to alleviate symptoms of PTSD. The app can be used on an iOS compatible phone and involves a training program that aims to directly reduce threat sensitivity by modifying attention. The contents of the app will be personalized for each user.
15958827|NCT03196999|Behavioral|Neutral Attention Training Condition|This self-help program is a placebo control program that will be used on an iOS compatible phone. The placebo will contain only neutral words.
15958828|NCT03196999|Behavioral|Non-Personalized Attention Bias Training|This self-help program administered on an app will aim to reduce neurobiological threat sensitivity with the ultimate goal of a low-cost and highly scalable self-help tool to alleviate symptoms of PTSD. The app can be used on an iOS compatible phone and involves a training program that aims to directly reduce threat sensitivity by modifying attention. The contents of the app will be the same for each user.
15958829|NCT03196986|Drug|MIL60|15mg/kg in combination with paclitaxel/carboplatin for 6 cycles, then maintains at 7.5mg/kg
15958830|NCT03196986|Drug|Bevacizumab|15mg/kg in combination with paclitaxel/carboplatin for 6 cycles, then switched to MIL60 at 7.5mg/kg
15958831|NCT03196973|Drug|DF289 plus DF277|1 vial into the affected ear twice daily for 7 days
15958832|NCT03196973|Drug|DF289|1 vial into the affected ear twice daily for 7 days
15958833|NCT03196973|Drug|DF277|1 vial into the affected ear twice daily for 7 days
15958834|NCT03196947|Drug|APO010|APO010 is given iv on D1, D8 and D15 followed by a one-week drug rest (cycle duration 4 weeks).
15958835|NCT03196934|Drug|Cannabidiol oral solution|Cannabidiol; Pharmacological class of drug
15958836|NCT03196921|Drug|Encochleated Amphotericin B|lipid-crystal nanoparticle formulation of amphotericin B; oral
15958837|NCT03196908|Dietary Supplement|Energy Drink Brand 1|Two 16-oz containers of Energy Drink Brand 1 consumed in 60 minutes
15958838|NCT03196908|Dietary Supplement|Energy Drink Brand 2|Two 16-oz containers of Energy Drink Brand 2 consumed in 60 minutes
15958839|NCT03196908|Other|Placebo|Lime juice, water, and cherry flavoring
15958840|NCT03196895|Behavioral|Weight reduction training|6 one-hour sessions of conventional weight reduction training
15958841|NCT03196895|Behavioral|PPG training|Four 90-minute sessions of glycemic load and exercise training
15958842|NCT03196895|Behavioral|discrete BG feedback|Blood glucose feedback from structured self-monitoring of blood glucose
15958843|NCT03196895|Behavioral|continuous BG feedback|blood glucose feedback from continuous glucose monitoring
15958844|NCT03196882|Drug|40mg/day of iron|Ferrimanitol ovalbumin granulated. Powder for oral solution. The doses of 40 mg per day of elemental iron correspond to 300 mg ferrimanitol ovoalbumin
15958845|NCT03196882|Drug|20mg/day of iron|Ferrimanitol ovalbumin granulated Powder for oral solution. The doses of 20 mg per day of elemental iron correspond to 150 mg ferrimanitol ovoalbumin
15958846|NCT03196882|Drug|80mg/day of iron|Ferrimanitol ovalbumin granulated. Powder for oral solution The doses of 80 mg per day of elemental iron correspond to 600 mg ferrimanitol ovoalbumin.
15958847|NCT03196869|Device|Chrono-chemotherapy|Chrono-chemotherapy+concurrent radiochemotherapy
15958848|NCT03196869|Device|Routine intravenous drip|Routine intravenous drip-chemotherap
15958849|NCT03196869|Drug|induction Chrono-chemotherapy|Experimental group:docetaxel,cisplatin,5-FU
15958850|NCT03196869|Drug|induction Routine-chemotherapy|control group:docetaxel,cisplatin,5-FU
15958851|NCT03196869|Drug|cisplatin chrono-chemotherapy|Experimental group: cisplatin chrono-chemotherapy
15958852|NCT03196869|Drug|cisplatin routine-chemotherapy|control group:cisplatin routine-chemotherapy
15958853|NCT03196869|Radiation|intensity-modulated radiation therapy|control group is similar to Experimental group
15958854|NCT03196856|Behavioral|Resistance and Plyometric Exercise|12 weeks of Resistance (twice weekly) and Plyometric (once weekly) training
15958855|NCT03196856|Dietary Supplement|Greek Yogurt (0% Plain)|200g 3x/day for 12 weeks.
15958856|NCT03196856|Dietary Supplement|Placebo - Study Designed Supplement|Iso-energetic to yogurt. 3x/day for 12 weeks.
15958857|NCT03196843|Drug|Raltitrexed|Raltitrexed 2.5mg/m2 on day 1,22,43 during radiotherapy
15958858|NCT03196843|Radiation|Intensity Modulated Radiotherapy|Radical radiotherapy:70Gy/2Gy/7 weeks Preoperative and postoperative adjuvant radiotherapy:50-60Gy/2Gy/5-6 week
15958859|NCT03196830|Biological|CAR-T|For eligible patients, CAR-T cells targeted to patients' tumor cell antigen will be infused after 48 hours later of chemotherapy
15958860|NCT03196817|Drug|betamethasone dipropionate, betamethasone disodium phosphate and lidocaine 2%|6.43 mg of betamethasone dipropionate, 2.63 mg of betamethasone disodium phosphate and 0.5 ml plus lidocaine 2%
15958864|NCT03196791|Drug|Sugammadex Sodium|"INDICATIONS AND USAGE BRIDION® is indicated for the reversal of neuromuscular blockade induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. BRIDION (sugammadex) injection is a sterile, clear, colorless to slightly yellow-brown, non-pyrogenic aqueous solution intended for intravenous infusion.
~DOSAGE AND ADMINISTRATION BRIDION (sugammadex) injection, for intravenous use, should be administered by trained healthcare providers familiar with the use, actions, characteristics, and complications of neuromuscular blocking agents (NMBA) and neuromuscular block reversal agents."
15958865|NCT03196778|Radiation|Low Dose Radiotherapy|Patients will receive 10 fractions of very low dose hemi-body radiation, delivered, twice per week, over five weeks
15958866|NCT03196765|Drug|Sobetirome (NV1205)|Once a day oral dose of the study drug
15958867|NCT03196752|Procedure|laryngeal handshake|palpate for the cricothyroid membrane using the laryngeal handshake technique
15958868|NCT03196752|Other|simple palpation|conventional
15958869|NCT03196739|Device|Virtual rehabilitation|A total of 10 sessions were held for 30 minutes, 2 to 3 times a week for upper limb rehabilitation using immersive virtual reality under the assistance of an occupational therapist.
15958870|NCT03196726|Behavioral|Brief Cognitive Behavioral Therapy|Week 1: Understanding postnatal depression Week 2: Relaxation techniques and tips to reduce stress Week 3: Positive thinking style and Self-Esteem Week 4: Relationship with partner Week 5: Relationship with infant Week 6: Relapse prevention
15958871|NCT03196726|Behavioral|standard management based on Clinical Practice Guideline|Mild depression: behavioral therapy; moderate depression: behavioral therapy and consider anti-depressant if required
15958872|NCT03196713|Behavioral|Early Intensive Behavioral Intervention|
15958873|NCT03196700|Radiation|Short course radiotherapy|An accelerated hypo-fractionation radiotherapy is delivered for palliation in patients with metastatic or locally advanced head and neck cancer.
15958874|NCT03196674|Other|Biofeedback via motion capture|The motion capture system will provide visual and auditory feedback of success, via a large screen, located on the wall. This could be manipulated so that the feedback is provided for a slightly higher range than instructed by the therapist.
15958875|NCT03196661|Biological|Influenza A (H7N9) virus vaccine|To prevent the infection of H7N9 virus.
15958876|NCT03196648|Other|Gingival health formulation in an accelerating device|The intervention is a gingival health formulation for soft tissue maintenance, oral malodor and gentle teeth whitening to be used with the GLO Science Device
15958877|NCT03196648|Other|Gingival health formulation on a toothbrush|The intervention is a gingival health formulation for soft tissue maintenance, oral malodor and gentle teeth whitening to be used on a toothbrush together with toothpaste.
15958878|NCT03196648|Other|OTC fluoride toothpaste|OTC anti-cavity toothpaste containing fluoride and sodium monofluorophosphate.
15958879|NCT03196635|Device|Patient-Assisted (PA) Breast Compression|The technologist will properly position the breast and apply minimum compression. The subject will be instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image will be acquired. This will be done for both standard views CC & MLO.
15958880|NCT03196635|Device|Technologist-Controlled (TC) Breast Compression|TC compression will be conducted per standard of care practices at the site.
15958881|NCT03196622|Device|Handgrip test|Handgrip strenght can be used in daily clinical practice to screen patients having sarcopenia to improve treatment and quality of life.
15958882|NCT03196609|Biological|Collection of stool and serum samples|"During the inclusion visit (for the 5 cancer sites): Stool collection (1 tube RNA later + 1 tube DMQO-EDTA) +Blood sample (1 tube SST + 1 tube EDTA)
~1 month after treatment (only for non-small cell lung cancer): Stool collection (1 tube RNA later + 1 tube DMQO-EDTA) + Blood sample (1 tube SST + 1 tube EDTA)"
15958883|NCT03196596|Other|Computer simulation|In these patients, a computer simulation model will be obtained based on pre procedural CT
15958884|NCT03196583|Device|Velo-Lingual Bite (BVL)|The administration of the device will proceed according to both the essential requirements of the European directives concerning medical devices (Annex I and X of directive 93/42/EEC) and the clinical practice standards and guidelines provided by the AASM and AASDM. These include the obtainment of alginate impression of both jaws and an interocclusal record, with the mandible at 50% of its maximal protrusive position. Since no single standard titration protocol is available, progressive mandibular advancement will be conducted according to the best available medical standard.
15958885|NCT03196570|Behavioral|Physical Activity Intervention|After randomization into the intervention arm, participants will be instructed on how to use the Spanish language study website. During the six month intervention, they will complete online questionnaires to determine their stage of change towards increasing physical activity. A manual of information will be automatically generated based on their responses. Participants can read this information online, along with tip sheets related to increasing physical activity. On the website they can also set weekly goals and log their weekly PA. It will also include short videos with demonstrations for PA they can do at home and around their neighborhood. Information will also include community resources (community centers, public events, parks) where they can be physically active. Participants will also receive prompts and encouragement via text-message to encourage them to log into the website and continue to track their progress.
15958886|NCT03196570|Behavioral|Wellness Contact Control|Participants in the control arm will attend the same baseline orientation sessions and measurements as the intervention arm. After randomization into the control group, participants will complete an introductory in-person session to introduce them to a website, similar in design, with information on health topics other than physical activity, including diet and other factors associated with CVD risk. It will include information from NHLBI heart health materials for Latinos. Topics include healthy eating, increasing fruit and vegetable consumption, reducing fat and salt intake, learning about cholesterol, stress management. Participants will log onto a separate website unique to the control group and complete monthly surveys on the wellness topics and their progress. Participants will also receive prompts and encouragement text-messages to encourage them to log onto the website.
15958887|NCT03196557|Drug|Prenisolone|Specified dose on specified days
15958888|NCT03196557|Drug|Placebo|Specified dose on dose on specified days
15959025|NCT03195556|Device|Ultrasound|Ultrasound exposure of Definity microbubbles infused over 10 min. Ultrasound administered at 1.3 MHz, mechanical index of 1.3, and pulsing interval of 10 s.
15958889|NCT03196544|Behavioral|Social Approach Training (5 sessions)|5 one-hour, clinician-administered treatment sessions focused on presenting rationale and instructions for completing positive activity exercises (e.g., gratitude, acts of kindness) designed to increase positive emotions, cognitions, and behaviors.
15958890|NCT03196544|Behavioral|Social Approach Training (10 sessions)|10 one-hour, clinician-administered treatment sessions focused on presenting rationale and instructions for completing positive activity exercises (e.g., gratitude, acts of kindness) designed to increase positive emotions, cognitions, and behaviors.
15958891|NCT03196531|Drug|Loratadine (Xisimin [Test Treatment])|Participants will receive 10 mg loratadine as Xisimin (test treatment) as per the treatment sequence.
15958892|NCT03196531|Drug|Loratadine (Clarityne [Reference Treatment])|Participants will receive 10 mg loratadine as Clarityne (reference treatment) as per the treatment sequence.
15958893|NCT03196518|Procedure|PET Imaging|PET/CT study immediately after injection
15958894|NCT03196518|Other|18F-tetrafluoroborate (18F-TFB)|administration of a single dose of approximately 5-10 mCi 18F-TFB (mass <= 50 μg) for imaging purposes
15958895|NCT03196505|Drug|Exparel 266 MG Per 20 ML Injection|Liposomal bupivacaine 20mL of injectable saline diluted with 60 ml of 0.25% Marcaine and 20 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive a 20 ml mixture locally infiltrated at each trocar incision site (5 sites).
15958896|NCT03196505|Drug|Bupivacaine|60 milliliters (ml) of 0.25% bupivacaine diluted with 40 ml of saline for a total of 100 ml. After induction of anesthesia, the patients will receive 20 ml mixture locally infiltrated at each trocar incision site (5 sites).
15958897|NCT03196492|Other|No intervention|No intervention
15958898|NCT03196479|Drug|ketamine and propofol mixture with 1:6 ratio|K16: K16 group was received ketamine:propofol with ratio of 1:6, filled in 50 cc syringe, which consisted of 1 ml of ketamine (50 mg/ml), 30 ml of 1% propofol (10 mg/ml), and 19 ml of normal saline so that every ml of mixture consisted of 1 mg of ketamine and 6 mg of propofol
15958899|NCT03196479|Drug|ketamine and propofol mixture with 1:4 ratio|K14 group was received ketamine:propofol with ratio of 1:4, filled in 50 cc syringe, which consisted of 1 ml of ketamine (50 mg/ml), 20 ml of 1% propofol (10 mg/ml), and 29 ml of normal saline so that every ml of mixture consisted of 1 mg of ketamine and 4 mg of propofol
15958900|NCT03196466|Biological|Valproic acid|titration
15958901|NCT03196466|Biological|carbamazepine|titration
15958902|NCT03196466|Biological|phenobarbital|titration
15958903|NCT03196466|Biological|phenytoin|titration
15958904|NCT03196466|Biological|levetiracetam|titration
15958905|NCT03196466|Biological|lamotrigine|titration
15958906|NCT03196466|Biological|topiramate|titration
15958907|NCT03196466|Biological|oxcarbazepine|titration
15958908|NCT03196466|Biological|stiripentol|titration
15958909|NCT03196466|Biological|clobazam|titration
15958910|NCT03196466|Biological|brivaracétam|titration
15958911|NCT03196466|Biological|felbamate|titration
15958912|NCT03196466|Biological|lacosamide|titration
15958913|NCT03196466|Biological|rufinamide|titration
15958914|NCT03196466|Biological|gabapentine|titration
15958915|NCT03196466|Biological|pregabaline|titration
15958916|NCT03196466|Biological|sultiame|titration
15958917|NCT03196466|Biological|tiagabine|titration
15958918|NCT03196466|Biological|vigabatrine|titration
15958919|NCT03196466|Biological|mesuximide|titration
15958920|NCT03196466|Biological|primidone|titration
15958921|NCT03196466|Biological|perampanel|titration
15958922|NCT03196466|Biological|ethosuximide|titration
15958923|NCT03196466|Biological|zonisamide|titration
15958924|NCT03196466|Biological|cannabidiol|titration
15958925|NCT03196466|Other|genetic polymorphisms|genetic polymorphisms
15958926|NCT03196453|Dietary Supplement|Probiotic|probiotic and/or placebo intervention in toddlers
15958927|NCT03196427|Drug|Vedolizumab|Vedolizumab intravenous infusion.
15958928|NCT03196414|Biological|CART-138/BCMA/19/more|Cyclophosphamide，Fludarabine，CART-138/BCMA /19/more cells Cyclophosphamide: 300 mg/m2 IV over 30 minutes on days -5 , -4,and -3; Fludarabine: 30 mg/m2 IV over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3 Biological: Anti-CD138/BCMA/CD19/more total CART cells 5x106- 100x106 CAR+ T cells per kg of recipient bodyweight
15958929|NCT03196401|Drug|Durvalumab|durvalumab 1500mg administered intravenously every 28 days, for a total of six doses
15958930|NCT03196401|Radiation|Radiation therapy|concurrent definitive radiation therapy to the bone plasmacytoma initiated within two weeks of starting
15958931|NCT03196388|Drug|Enzalutamide|"Radiation: External Beam Radiation Dose will be normalized such that exactly 98% of the PTV (planned target volume) receives the prescription dose and will be scored as per protocol. The maximum allowable dose within the PTV is 107% of the prescribed dose to a volume that is at least 0.03 cc. The minimum allowable dose within the PTV is >95% of the prescribed dose to a volume that is at least 0.03 cc.
~EBRT shall receive prescription doses to the PTV 70 Gy delivered in 2.5 Gy"
15958932|NCT03196375|Drug|FLX-787-ODT (orally disintegrating tablet)|FLX-787-ODT taken three times daily for 28 days
15958933|NCT03196375|Drug|Placebo ODT|Placebo ODT taken three times daily for 28 days
15958934|NCT03196362|Drug|Pioglitazone + Metformin|One tablet of fixed dose of Pioglitazone/ Metformin (15mg/30mg) will be given twice daily
15958935|NCT03196362|Drug|Placebo Oral Tablet|One tablet of placebo will be given twice daily
15958936|NCT03196349|Drug|Warfarin|Will be randomized to receive open label warfarin daily to achieve a target INR of 2-3
15958937|NCT03196349|Drug|Apixaban 2.5 MG|Will be randomized to receive open label apixaban of 2.5 mg twice daily
15958938|NCT03196349|Drug|Rivaroxaban 10 MG|Will be randomized to receive open label rivaroxaban of 10mg daily
15958939|NCT03196336|Other|Pharmacotherapy follow-up care|The pharmacotherapy follow-up care consists of five pharmaceutical consultations (every up to 2-3 months) aimed to identify, prevent and solve the drug related problems regarding the indication, effectiveness and safety of the use of medicines.
15958940|NCT03196310|Drug|Platelet Concentrate|Platelet Rich plasma
15958941|NCT03196310|Drug|Corticosteroid injection|Kenalog
15958942|NCT03196310|Other|Normal Saline|Control Group - Placebo
15958944|NCT03196297|Drug|Turoctocog alfa|Breakthrough bleeding episodes will be treated by the patients at home with turoctocog alfa at the discretion of the study doctor, who will also choose dose levels
15958947|NCT03196271|Dietary Supplement|Ketocal 2.5:1|A ketogenic feed for the dietary management of intractable epilepsy is given over a period of four weeks, after a control period of 4 weeks. The amount of the feed given is determined by the Dietitian and/or Doctor responsible for the patient's care (at least one carton per day).
15958948|NCT03196258|Behavioral|Cognitive behavioural therapy|Participants who are randomized to the CBT intervention are required to start CBT within 8 weeks of their fracture surgery. The CBT intervention will consist of 6 weekly one-on-one, 1-hour sessions that will focus on addressing maladaptive beliefs related to pain and recovery as well as teaching skills to enhance coping and management of pain symptoms. The specific focus of CBT sessions will be informed by each individual patient's responses on the SPOC questionnaire. All other aspects of post-operative care will be at the discretion of participant's surgeon
15958949|NCT03196245|Other|There is no intervention.|There is no intervention. This is a purely observational study. We enrolled pregnant women as they received a vaccine as part of their regular medical care; we did not administer the vaccine. We also enrolled pregnant women acutely infected with influenza.
15958950|NCT03196232|Drug|Epacadostat|Given PO
15958951|NCT03196232|Drug|Pembrolizumab|Given IV
15958952|NCT03196219|Drug|C16G2|C16G2
15958953|NCT03196219|Other|Placebo|Varnish Placebo
15958954|NCT03196206|Drug|BMS-986177|Oral Suspension
15958955|NCT03196193|Procedure|Open Reduction and Internal Fixation|Fractured bone fragments are reduced and stabilized by intramedullary nail.
15958956|NCT03196193|Device|ZNN CM Asia|Reduced bone fragments are to be stabilized by Zimmer Natural Nail CM Asia System.
15958957|NCT03196193|Device|Anterior Support Screw|Experimental group will receive insertion of ACE 4.5/5.0mm cannulated lag-screw anteriorly to Zimmer Natural Nail CM Asia Lag-screw.
15958958|NCT03196180|Drug|Imiquimod|Given intravaginally
15958959|NCT03196180|Drug|Topical Fluorouracil|Given intravaginally
15958960|NCT03196167|Drug|Sugammadex|The administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy.
15958961|NCT03196167|Other|Placebo|The administration of the study and placebo compounds will be performed by CTICU nurses who will receive the drugs in a blinded fashion from the departmental research pharmacy.
15958962|NCT03196154|Diagnostic Test|Fasting insulin level|Fasting insulin and C-peptide level measured using LCMS which is then used to calculate the insulin resistance and beta cell function using homeostasis model assessment
15958963|NCT03196154|Diagnostic Test|Plasma drug level|Plasma trough level of metformin and gliclazide will be measured using LCMS to ensure true compliance.
15958964|NCT03196141|Diagnostic Test|StO2 and EndoPAT|"StO2 probe is a lightweight plastic probe that will be applied over the brachioradilalis muscle (anterolatereal aspect of the forearm) where there is less subcutaneous fat and taped in place.
~The EndoPAT probe will be place on a finger on the same arm.
~Pulse oximeter probes will be connected to a finger on each hand."
15958965|NCT03196128|Other|Digital communication|Communicating with patients via email and text message.
15958966|NCT03196128|Other|Non digital|Communicating with patients via telephone and written appointment letters.
15958967|NCT03196102|Behavioral|BTI|Brief Tobacco Intervention (BTI). The group intervention was designed to include the components of effective tobacco control programs for military personnel, and specifically tailored to the Technical Training environment. The intervention is approximately 40 minutes and delivered in a group format (e.g., groups of 50 Airmen). The format of the BTI is meant to be interactive, utilizing the Socratic teaching style and eliciting participation through the principles of motivational interviewing. A series of open-ended questions, reflections, and decisional balance, were used to increases motivation to remain tobacco free.
15958968|NCT03196102|Behavioral|Cigarette smoking military tailored pamphlet|The Airmen's Guide is 5×7 inches, 46 pages, with text and color illustration. The text covers the advantages of remaining tobacco-free after Basic Military Training, and the opportunity the ban provides to begin a lifetime without tobacco, focusing on cigarettes and smokeless tobacco. Information is included about challenges and coping suggestions for the times that Airmen are at particular risk of smoking. The text is supplemented by images created specifically for Airmen and designed to reinforce the messages that smoking: 1) is responsible for more fatalities than combat; 2) conveys a negative image to civilians; and 3) impedes military readiness and promotion through the ranks.
15958969|NCT03196102|Behavioral|Standard smoking cessation intervention|This booklet is a 36-page, comprehensive guide for quitting smoking with 7 pages dedicated to relapse-prevention.
15958970|NCT03196089|Procedure|Oxygen application|Supplemental oxygen via mask
15958971|NCT03196076|Drug|Perflutren Lipid microsphere|Perflutren will be administered in a bolus or continuous infusion using the dosing range and administration type within the perflutren prescribing information.Once perflutren lipid has been administered, the transducer is maintained in a constant position over the area of interest to show the target lesion in order to assess the enhancement pattern during the early, mid and late vascular phases. Images will also be taken of kidney parenchyma in a suitable longitudinal plane.If there are multiple lesions in one subject requiring a second dose, the subject will have the option to undergo a 2nd contrast-enhanced study 30-minutes after the initial contrast dose, per dosing instructions in the package insert.
15958972|NCT03196063|Other|Eccentric|Exercises based on eccentric contractions of the quadriceps femoris muscle, using a 15º inclined plane. A serie of 15 repetitions of the squat will be performed, with the frequency of three times a week for eight weeks. The load of the exercises will be increased weekly.
15958973|NCT03196063|Other|Modified Protocol|Protocol based on the Heavy Slow resistance program, with the addition of an isometric phase at the beginning of the protocol, and with exercises using body weight without the use of mechanotherapy.
15958974|NCT03196050|Device|Handheld Device (Smart Phone)|"Handheld device will be used for 3 tasks:
~1x per day: status update (how are you today?)
~1x per week: 10 questions on general health status
~1x per month: EORTC QLQ-C30 questionnaire"
15958975|NCT03196037|Behavioral|Tai Chi|An 8-week Tai Chi intervention consisting of 75-minute group sessions held twice a week, over 8 weeks (i.e., total of 16 sessions).
15958976|NCT03196024|Behavioral|Family-focused intervention arm|Family pairs including an individual family member at-risk for type 2 diabetes or CVD and a co-participating family member will be enrolled in the study. After completing baseline data they will be randomly selected to participate in one of the two study arms. For the family-focused arm, the family pair will attend 8 2-hour weekly educational sessions about type 2 diabetes and CVD risk reducing lifestyle behaviors. The sessions will be presented by community health workers (CHWs) in Spanish to groups of 5 to 6 family pairs. Following completion of the sessions, data will be collected from the family pairs. CHWs will call monthly to provide information and support through the end of the 12-month period at which time data will be collected from the family pairs.
15958977|NCT03196024|Behavioral|Individual-focused intervention arm|Family pairs including an individual family member at-risk for type 2 diabetes or CVD and co-participating family member will be enrolled in the study. After completing baseline data pairs will be randomly selected to participate in one of two interventions. For the individual-focused intervention, the at-risk individual will attend 8 weekly 2-hour education sessions on type 2 diabetes and CVD risk reducing lifestyle behaviors. Sessions will be presented by CHWs in Spanish to groups of 10 to 12 individuals. Following completion of sessions, data will be collected from the individuals. CHWs will call monthly to provide information and support through the end of the 12-month period at which time data will be collected from the at-risk individuals and their co-participating family members.
15958978|NCT03196011|Other|TKR with mechanical alignment method|TKR implanted using traditional mechanical alignment methods
15958979|NCT03196011|Other|TKR with alternative alignment method|TKR implanted using alternative alignment methods
15958980|NCT03195998|Diagnostic Test|TcB Measurement|TcB measurements will be obtained within approximately 30 minutes of the TSB being drawn before initiation of phototherapy, approximately 24 hours after the initiation of phototherapy and approximately 24 hours after completion of phototherapy. The TcB measurement will involve lightly pushing three times at each site which will yield an average transcutaneous bilirubin value. This will be calculated for the interscapular, buttock and sternal automatically by the bilirubinometer. While on phototherapy a measurement of the diapered, non-exposed buttock area will be obtained at approximately 24 hours to coincide with the standard of care serum bilirubin measurement.
15958981|NCT03195985|Other|Mindfulness-based intervention|A shortened, 4 week mindfulness intervention course based on the original 8 week mindfulness-based stress reduction course by Jon Kabat-Zinn
15958982|NCT03195985|Other|Age Well psycho-education|4-week active control condition aimed at psycho-education regarding healthy ageing
15958983|NCT03195972|Other|Drug diary filling|patient will fill every day a drug diary
15958984|NCT03195959|Other|Hypoxia and Hyperoxia|10 minutes of breathing a gas mixture with FiO2 0.16 via a tight fitting mask. After 10 minutes of breathing ambient air (normoxia), patients were exposed to hyperoxia (FiO2 1.0) for 10 minutes.
15958985|NCT03195946|Drug|Lu AF35700|tablets for oral use, 10 mg/day
15958986|NCT03195946|Drug|Midazolam|syrup for oral use, 4mg/day
15958987|NCT03195946|Drug|Cocktail of CYP450 substrates|Caffeine tablets for oral use, 200 mg/day. Omeprazole tablets for oral use, 40 mg/day. Dextromethorphan tablets for oral use, 30 mg/day. Midazolam IV solution for Intravenous use, 0.025 mg/kg/day
15958988|NCT03195933|Other|Cortisol|We compared placebo vs. 20 mg oral dose of cortisol, which pharmacologically elevated cortisol levels.
15958989|NCT03195933|Other|Placebo|We compared placebo vs. 20 mg oral dose of cortisol, which pharmacologically elevated cortisol levels.
15958990|NCT03195920|Device|Enhanced Lithotripsy System|The Enhanced Lithotripsy System is a type of lithotripsy system comprising a console, treatment head, and Acoustic Energy Focusing material. Operation of the Enhanced Lithotripsy System entails combined action of extracorporeal insonation and Acoustic Energy Focusing material to fragment urinary stones.
15958991|NCT03195907|Other|Pulmonary physiotherapy|
15958992|NCT03195894|Device|TripleA|
15958993|NCT03195881|Other|Ocular ultrasound|Post-cardiopulmonary arrest patients meeting inclusion/exclusion criteria for targeted temperature management will undergo ocular ultrasound at three time points: within 6 hours (h) of initiation of hypothermic protocol, between 10-24 h after hypothermic protocol initiation, and between 24-36 h after hypothermic protocol initiation.
15958994|NCT03195868|Device|Realief Therapy|Patients will be treated using class IV laser using a proprietary algorithm developed by REALief neuropathy centers
15958995|NCT03195855|Other|Manual therapy / joint mobilisations|Manual therapy is a common form of treatment employed usually by physiotherapists, in order to help increase range of motion of a specific joint region by restoring the arthrokinematic accessory gliding and rolling movement that is associated with normal joint movement. The hypothesised mechanism of action for this is that improvements of gliding and rolling will normalise osteokinematic rotation and consequently enable the normalisation of active movements. Another possible mechanism of action of mobilisations includes increasing the extensibility of the noncontractile capsular and ligamentous tissues. The effectiveness of passive accessory gliding techniques to increase joint ROM has been widely explored in the literature; with some studies revealing an increase in ankle dorsiflexion and others no change in ankle dorsiflexion. However, the subjects taking part in these studies were people without diabetes and mostly people with ankle sprains or ankle instability.
15958996|NCT03195842|Other|Recordable card|
15958997|NCT03195829|Behavioral|Computerized Cognitive Stimulation|The intervention group performed 12-week, 90-minutes per week of cognitive stimulation in group using a tablet with a commercial software with specific exercises to train the cognitive functioning and promote the relation ties in group-session.The program's difficulty level was adjusted to the MMSE score, and was gradually increased.
15958998|NCT03195829|Behavioral|Multimedia-based internet|The active control group had access to different Multimedia contents (travel, photos, music, TV program, cooking recipes) using a tablet, 90-minutes per week each week during 3-months. Each group session was centered in a particular topic, participants were able to select different media free available in Internet.
15959026|NCT03195543|Diagnostic Test|Platelet function analyzer-100|The PFA-100 system evaluates primary hemostasis in whole blood samples.
15958999|NCT03195816|Behavioral|Computerized Cognitive training|Experimental group will receive 1 year of a computer-based cognitive stimulation program, first 6 months, 60-minutes twice a week and next 6 months once a week training in group-setting, using a tablet with a software with specific training focused on attention, executive and speed processing functions.
15959000|NCT03195803|Behavioral|Computerized Cognitive Stimulation|All participants performed 12-week, 60-minutes twice a week of a computer-based cognitive stimulation program in group-setting, using a tablet with a software with specific training focused on attention, executive and speed processing functions.
15959001|NCT03195790|Behavioral|Family-based pediatric obesity treatment|Families with at least one overweight/obese child between ages 6 and 11 years will receive 12-months of family-based pediatric obesity treatment that emphasizes healthy changes to the home environment and family routines. The intervention targets dietary intake, physical activity, and consistent sleep.
15959002|NCT03195777|Device|PET/CT|PET/CT imaging will be performed (with fluorodeoxyglucose, [FDG] as a tracer). Thereafter, subjects will be monitored for development of PTS. We will then assess the ability of PET/CT top predict the subsequent development of PTS.
15959003|NCT03195764|Drug|T-1101 (Tosylate)|T-1101 (Tosylate) powder in bottle
15959004|NCT03195751|Device|Software development kit measurements|This proprietary SDK (FocusMotion) processes user motions recorded by the hardware (accelerometer, gyroscope, magnometer). As data is collected, the software development kit (SDK) classifies the motion as repetitive or non-repetitive, and repetitive motions are further analyzed. As the user completes a movement, the SDK tracks the number of repetitions performed, technique, and rest time. The SDK can provide real-time feedback to the user regarding their form by comparing the movement to a template of an ideal motion for that particular action. The SDK is compatible with any operating system, phone, or wearable device, providing seamless integration with pre-existing technologies.
15959005|NCT03195751|Device|Manual Goniometer Measurements|A manual goniometer was used to measure the range of motion of the shoulder.
15959006|NCT03195738|Other|Cognitive Orientation to Occupational Performance (CO-OP)|"In the CO-OP intervention participants are first assisted to identify 3-5 occupation based goals which then become the focus of the intervention sessions. Over the course of the 10 intervention sessions, participants are guided to learn and practice problem solving using a metacognitive strategy, Goal-Plan-Do-Check applied to their self-identified goals. Study therapists use 'guided discovery' an iterative technique to facilitate problem solving by the participant to develop plans to work toward their goals and to evaluate their progress. Intervention takes place in the location that is most meaningful for the participant's selected goal (e.g. home, school, playground etc.). Participants are provided with a work book to track progress."
15959007|NCT03195725|Other|Review of notes|No intervention will occur
15959008|NCT03195699|Drug|TTI-101|Patients in the first cohort are treated at dose level 1. Each cohort of a dose level will include at least 3 patients, who will be evaluated for at least one cycle (28-days). The next dose level will be determined after careful review of the tolerability and pharmacokinetics of the previous cohort. If the current dose is the lowest dose and the rule indicates dose de-escalation, we will treat the new patients at the lowest dose unless the number of DLTs reaches the elimination boundary, at which point we will terminate the trial for safety. If the current dose is the highest dose and the rule indicates dose escalation, we will treat the new patients at the highest dose.
15959009|NCT03195686|Device|PLE100(Inbody®)|PLE100(Inbody®) monitoring in children to be operated under the total intravenous anesthesia (Propofol)
15959010|NCT03195673|Drug|Terazosin|TZ 0.5mg once a day for 3-7 days before carotid artery stenting to 30 days later.
15959011|NCT03195673|Procedure|Carotid artery stenting|Carotid artery stenting is an alternative treatment of carotid artery stenosis, which would be performed by experienced neuroradiologist according to the latest guideline from American Heart Association and American Stroke Association.
15959012|NCT03195660|Device|ASV Therapy|AirCurve 10 ASV device set up in AutoSet mode
15959013|NCT03195647|Drug|Potassium|"The trial treatment will start when patients are admitted to the intensive care unit after their surgery. The patient will undergo regular blood investigations, as per current practice. The frequency of K+ monitoring while on ICU will be according to clinician / nursing staff preference.
~Potassium supplementation will be according to local hospital protocols. This can be either via an intravenous infusion or as a tablet. Patients will otherwise be treated as per current hospital protocol."
15959014|NCT03195634|Drug|Carvedilol|an initial dose of 6.25 mg once-daily that was adjusted over 5-7 days to the maximum tolerated dose, keeping heart rate >55 beats per minute, or up to 12.5 mg/day
15959015|NCT03195621|Device|Stent implantation|Stent placement after risk factors assessment plus FFR or ultrasound or OCT detection for critical lesions.
15959016|NCT03195608|Device|Lane change assistance system|This study will investigate the feasibility and preliminary efficacy of a 6-session lane change ADAS-intervention on the simulated driving performance of individuals with mild to moderate PD. We anticipate that the use of lane change assist technology will decrease the number of driving errors in individuals with PD. As this is a feasibility study, we will evaluate: -recruitment capability and sample characteristics - data collection methods, procedures, and outcome measures - acceptability and suitability of the lane change assist technology intervention - preliminary efficacy The outcomes of this study will inform the design of a larger study, should such large-scale study be warranted.
15959017|NCT03195608|Behavioral|Active Control|Participants will practice their driving on a driving simulator with feedback form a trained interventionist.
15959018|NCT03195595|Device|mitral valve replacement|early postoperative outcome regarding pain in minimal invasive technique
15959019|NCT03195595|Device|conventional mitral valve replacement|early postoperative outcome regarding pain in conventional median sternotomy
15959020|NCT03195582|Drug|Corsodyl|following local anesthesia buccal and lingual flaps will be raised minimally, the cover screw will be removed from the implant. In the test group, Corsodyl gel 1% CLOROHEXIDINE will be applied on the implant and the healing abutment.
15959021|NCT03195569|Drug|QL1101|targeted vascular endothelial growth factor (VEGF) monoclonal antibodies
15959022|NCT03195569|Drug|Avastin®|targeted vascular endothelial growth factor (VEGF) monoclonal antibodies
15959023|NCT03195569|Drug|Paclitaxel|175 mg/m2, IV following investigational product on day 1 of each 21 day cycle.
15959024|NCT03195569|Drug|Carboplatin|AUC 5 IV, following paclitaxel on day 1 of each 21 day cycle.
15959027|NCT03195543|Diagnostic Test|Light transmission aggregometry|Light transmission aggregometry is the gold standard method for assessing platelet function.
15959028|NCT03195543|Diagnostic Test|Rotational thromboelastometry|ROTEM is a viscoelastic method for hemostasis testing in whole blood.This assay investigates the interaction of blood cells, coagulation factors and their inhibitors during clotting and subsequent fibrinolysis.
15959029|NCT03195543|Diagnostic Test|Endogenous thrombin potential|The endogenous thrombin potential assesses the amount of thrombin which can be generated after the in vitro activation of coagulation and represents the balance between pro- and anti-coagulant forces in plasma.
15959030|NCT03195530|Drug|Propofol|Induction of anesthesia using propofol, and recording the BIS values and EEG patterns during the induction
15959031|NCT03195517|Other|Physical exercise|
15959032|NCT03195504|Device|HFNC|High flow nasal oxygen (60 l) under GA
15959033|NCT03195504|Device|CON (control)|Standard oxygen (10-15 l) under GA
15959034|NCT03195491|Biological|Nivolumab|Intravenous infusion administered over 30 minutes at 240 mg
15959035|NCT03195478|Drug|Nivolumab|Specified dose of Nivolumab on specified days.
15959036|NCT03195478|Drug|Ipilimumab|Specified Dose of Ipilimumab on specified days
15959037|NCT03195465|Dietary Supplement|Dark Chocolate|Dark Chocolate bars with 70% cacao and 30% organic cane sugar where 4 squares of the dark chocolate will be administered twice daily between the hours of 6 a.m. and 6 p.m. daily for four weeks.
15959038|NCT03195452|Drug|Raltegravir and 2 Nucleoside/Nucleotide reverse transcriptase inhibitor (NRTI)|All virologically suppressed
15959039|NCT03195439|Device|TTP|TTP™ allows to continuously measure body temperature using a new non-invasive method, and was cleared for marketing by US FDA (K150160) for as a temperature monitoring system intended to measure and monitor core body temperature of patients of all ages, by applying a sensor unit on the forehead.
15959040|NCT03195426|Procedure|distal nerves blocks group|"ICB: US probe will be placed just below clavicle inferior to site of needle entry. Following identification of axillary artery and cords, the needle will be advanced posterior to axillary artery. 20 cc of Ropivacaine 0.375% will then be deposited in a U-shaped distribution posterior and to each side of the axillary artery.
~SSNB will be performed by locating the brachial plexus and the departure of the suprascapular nerve from the superior trunk under the inferior belly of the omohyoid muscle by sliding the transducer distally and then injecting 5 mL of ropivacaine 0.375%.
~SCNB will be performed injecting 5 mL of ropivacaine 0.375% in the intermuscular plane between the sternocleidomastoid and scalene muscles using a lateral to medial in-plane technique."
15959041|NCT03195426|Procedure|Diaphragmatic function assessment|"Diaphragmatic excursion will be assessed under ultrasound immediately before and after regional anesthesia.
~This a pain free and safe procedure, that we usually perform in patients at risk of respiratory failure."
15959042|NCT03195413|Procedure|Ultrasound-guided forearm nerve block|An ultrasound machine will be used to identify the median, radial, and ulnar nerves in the forearm, so that a needle may be used to apply lidocaine into the soft tissue space around those nerves.
15959043|NCT03195413|Drug|1:1 volume measured solution of: 1% lidocaine without epinephrine and 0.5% bupivacaine without epinephrine|This is the anesthetic solution that will be administered during the ultrasound-guided nerve block
15959044|NCT03195413|Device|Bedside ultrasound machine|This is the device that will be used to visualize tissues during the ultrasound-guided nerve block.
15959045|NCT03195400|Diagnostic Test|Oral Glucose Tolerance Test|The oral glucose tolerance test (OGTT) measures the body's ability to use a type of sugar, called glucose, that is the body's main source of energy. An OGTT can be used to diagnose prediabetes and diabetes.
15959046|NCT03195400|Diagnostic Test|Hyperglycemic Clamp|Test of beta-cell function and insulin secretion. Involves increasing and maintaining blood glucose concentration with IV variable infusion of dextrose.
15959047|NCT03195400|Diagnostic Test|Isoglycemic Intravenous Glucose Test|Test which exposes pancreas to blood glucose levels matched to the ones obtained at the OGTT.
15959048|NCT03195400|Diagnostic Test|Hyperinsulinemic Euglycemic Clamp and 2H20|Test is used to assess insulin effects on hepatic glucose production.
15959049|NCT03195387|Drug|MMV390048|Each tablet contains 20 mg MMV390048 and the following excipients: tartaric acid powder, copovidone (Plasdone S-630), hypromellose acetate succinate (AquaSolve HPMC-AS MF), croscaramellose sodium (Solutab), microcrystalline cellulose type 102 (Avicel PH-102), magnesium stearate (Ligamed MF-2-V).
15959050|NCT03195374|Other|Prescription Opioid Misus Index|Opioid misuse will be assessed by the Prescription Opioid Misuse Index (POMI) scale. A score ≥ 2 is considered positive and will define a misuse behavior.
15959051|NCT03195361|Device|SRS - Self Retaining Support system|
15959052|NCT03195348|Other|HBF Bed Rest|7 days of bed rest on hyper-buoyancy floatation (HBF)
15959053|NCT03195335|Other|Assessment via questionnaire|All the children will be assessed via assessment questionnaires.
15959054|NCT03195322|Procedure|Pre-pectoral Tissue Expander|All participants in the study will undergo bilateral mastectomy followed by Immediate, bilateral pre-pectoral tissue expander breast reconstruction with complete AlloDerm® coverage.
15959055|NCT03195309|Drug|Ropivacaine|Compare different concentration of ropivacaine and fentanyl for elective Cesarean delivery post operative pain control.
15959056|NCT03195309|Drug|Fentanyl|Compare different concentration of ropivacaine and fentanyl for elective Cesarean delivery post operative pain control.
15959057|NCT03195296|Other|No intervention|No intervention related to the study is foreseen
15959058|NCT03195283|Other|Meal service|The type of meal service in the hospital (usual care)
15959059|NCT03195270|Drug|[18F]FDG|10 mCi of [18F]FDG via the antecubital vein in a bolus injection
15959060|NCT03195270|Device|PET/MRI|PET/MRI hybrid scanner used as diagnostic device
15959061|NCT03195257|Other|GIP|On 3 matched days with 'hypoglycemia' (i.e. plasma glucose clamped between 3-7 mol/L for 120 minutes) either GIP (4 pmol/kg/min), glucagon-like-peptide-1 (GLP-1) (1 pmol/kg/min) or placebo (saline) was administered; and on 2 separately matched days with 'hyperglycemia' (i.e. clamped at 12 mmol/L for 90 minutes) either GIP (4 pmol/kg/min) or saline was administered.
15959062|NCT03195257|Other|GLP-1|On 3 matched days with 'hypoglycemia' (i.e. plasma glucose clamped between 3-7 mol/L for 120 minutes) either GIP (4 pmol/kg/min), glucagon-like-peptide-1 (GLP-1) (1 pmol/kg/min) or placebo (saline) was administered; and on 2 separately matched days with 'hyperglycemia' (i.e. clamped at 12 mmol/L for 90 minutes) either GIP (4 pmol/kg/min) or saline was administered.
15959063|NCT03195257|Other|Saline|On 3 matched days with 'hypoglycemia' (i.e. plasma glucose clamped between 3-7 mol/L for 120 minutes) either GIP (4 pmol/kg/min), glucagon-like-peptide-1 (GLP-1) (1 pmol/kg/min) or placebo (saline) was administered; and on 2 separately matched days with 'hyperglycemia' (i.e. clamped at 12 mmol/L for 90 minutes) either GIP (4 pmol/kg/min) or saline was administered.
15959064|NCT03195244|Other|Aquatic Physical Therapy|Swim Whisperer's Aquatic Therapy Sessions
15959065|NCT03195231|Drug|Wuling Powder|Patients of Wuling Group are instructed to take Wuling Powder 3 times a day and 3 pills each time for 12 weeks.
15959066|NCT03195231|Drug|Placebo|Patients of Placebo Group are instructed to take placebo drug 3 times a day and 3 pills each time for 12 weeks.
15959067|NCT03195218|Device|HRME examination|HRME will capture images from all areas considered abnormal by VIA and/or colposcopy. In addition, all four quadrants will be probed with HRME to ensure that any non-acetowhite lesions are also observed
15959068|NCT03195205|Diagnostic Test|OraQuick HCV Rapid Antibody Test|HCV Screening
15959069|NCT03195192|Other|biomarker study|This is a biomarker study
15959070|NCT03195166|Diagnostic Test|FloTrac sensor/Vigileo|blood pressure (systolic, diastolic and mean), stroke volume cardiac output ephedrine consumption after bupivacaine continuous spinal anesthesia
15959071|NCT03195153|Drug|Atorvastatin 80mg|30 DAYS OF atorvastatin 80 mg
15959072|NCT03195153|Drug|ALLOPURINOL 300 MG|30 DAYS OF ALLOPURINOL 300 MG
15959073|NCT03195153|Drug|Atorvastatin 80mg AND allopurinol 300 mg|30 days of atorvastatin and allopurinol 300 mg
15959074|NCT03195140|Device|Predictive Low Glucose Suspend|Application of Predictive Low Glucose Suspend
15959075|NCT03195127|Other|multimodal physical therapy|Consist of limb strengthening exercises, endurance training, and balance/coordination drills. These exercises and training maneuvers may involve the use of handheld weights, nautilus weight equipment, elastic exercise bands, stationary exercise machines (recumbent exercise cycles, hand ergometer cycles), or treadmills. If the subject is fit enough, Tai Chi may be added to as a training method to help improve your balance and strength. In addition, the subject will be asked to wear an accelerometer on their wrist
15959076|NCT03195114|Diagnostic Test|Multimodality Imaging and Biomarkers|Cardiac MRI, Cardiac MDCT, Echocardiography and Biomarkers Testing
15959077|NCT03195101|Procedure|transconjunctival orbitotomy approach|approach the orbital tumor through an incision in the conjunctiva, This is followed by blunt dissection of the tenons capsule. A traction suture is applied over the corresponding rectus muscle to guide the globe toward the desired direction. The orbital fat is retracted by malleable retractor and blunt dissection through the orbital connective tissue continues until reaching the edge of the tumor. After the mass is exposed, a biopsy or complete resection of the mass is taken place
15959078|NCT03195088|Drug|BI 473494|Solution for injection
15959079|NCT03195088|Drug|Placebo|Solution for injection
15959080|NCT03195075|Procedure|Endoscopic ultrasonography guided biliary drainage|Endoscopic ultrasonography guided biliary drainage includes rendezvous techniques, endoscopic ultrasonography guided choledochoduodenostomy, and endoscopic ultrasonography-guided hepatogastrostomy using self-expandable metal stent will be done for group 1
15959081|NCT03195075|Procedure|Percutaneous trans-hepatic biliary drainage|Percutaneous trans-hepatic biliary drainage in interventional radiology department using self-expandable metal stent will be done for group 2
15959082|NCT03195062|Other|Test meal|Liquid test meal (fructose+glucose)
15959083|NCT03195049|Diagnostic Test|blood group,complete blood count|measure levels of total and direct bilirubin before, during and after the procedure of exchange transfusion
15959084|NCT03195036|Behavioral|Home-based ECD services|Health facilities will be randomized to intervention and control groups. The clients at clinics assigned to the intervention group will receive Home-based Early Childhood Development (ECD+) program. The clients at clinics assigned to the control group will not receive the Early Childhood Development (ECD) program.
15959085|NCT03195023|Drug|Lisinopril|
15959086|NCT03195023|Drug|Amlodipine|Patients in this arm will receive antihypertensive treatment different from RAS blockers. If they previously received RAS blockers, they will be substitute for either Amlodipine or Lercanidipine +/- diuretics
15959087|NCT03195010|Biological|Platelet Transfusion|Undergo lower dose platelet transfusion
15959088|NCT03195010|Biological|Platelet Transfusion|Undergo higher dose platelet transfusion
15959089|NCT03194997|Other|Dance|The Dance intervention will be performed with belly dance methods. It will occur 3 times per week, during 16 weeks, with 60 minutes the session.
15959090|NCT03194997|Other|Pilates|The Pilates intervention will be performed using specific exercises of Pilates Methods. During the classes it will be used thera band, toning ball and pilates ball. It will occur 3 times per week, during 16 weeks, with 60 minutes the session.
15959091|NCT03194984|Drug|Hydrogen peroxide 35%|The office bleaching products will be applied on one of dental hemi-arch of young patients (18-25 years) or adult patients (40-65 years), after randomization. The product will apllied according manufacture instrutions.
15959092|NCT03194984|Drug|Hydrogen peroxide 38%|The office bleaching products will be applied on one of dental hemi-arch of young patients (18-25 years) or adult patients (40-65 years), after randomization. The product will apllied according manufacture instrutions.
15959093|NCT03194971|Other|Tumor samples from patients treated with TTFields at initial diagnosis.|Pathological assessment of tumor cellularity, apoptosis, and quantitative histo-morphometry of residual tumor cells will be performed. Each metric will be statistically compared between groups.
15959094|NCT03194971|Device|Tumor samples from patients treated with TTFields at tumor recurrence.|Pathological assessment of tumor cellularity, apoptosis, and quantitative histo-morphometry of residual tumor cells will be performed. Each metric will be statistically compared between groups.
15959122|NCT03194802|Behavioral|Sleeping Without Pills Program|Participants receive this program online and are asked to log in daily for 6 weeks.
15959123|NCT03194802|Behavioral|Self-monitoring|Participants enter sleep diary data online daily for 6 weeks
15959154|NCT03194620|Other|Control|Single oral intake of a flavanol-free, fruit flavored, non-dairy drink.
15959155|NCT03194607|Other|Functional walk tests|
15959156|NCT03194607|Other|3D analysis of locomotion and posture|
15959157|NCT03194607|Other|questionnaires|
15959220|NCT03194061|Radiation|Hypofractionated Radiotherapy|20 fractions of 275cGy 5 days/week
15959095|NCT03194958|Behavioral|Specialized Quitline|Very low-income smokers are different from other smokers in important ways not always addressed by standard quitline services. The research team and Alere staff has created custom protocols, scripts, prompts and other content to maximize intervention relevance and acceptability to very low-income smokers. Research Implementation Unit (RIU) coaches who will be delivering the Specialized Quitline services have received training from clinical quitline staff, the research team and 2-1-1 staff who have extensive experience with the target population. Focus areas for training and distinctive content and protocol for the Specialized Quitline include: health literacy, abstract vs. concrete language, lived experience, resource constraints, future orientation, getting cigarettes, living situation, phone/internet access.
15959096|NCT03194958|Behavioral|Basic Needs Navigator|Navigators will: (1) identify and assess smokers' needs, including the reasons they called 2-1-1; (2) jointly generate solutions to address the needs; (3) develop plans to carry out the solutions, including; (4) help prioritize among multiple needs; (5) identify community resources that could help solve the problem; (6) determine eligibility for services; (7) help smokers access available resources by scheduling appointments and provide appointment reminders; (8) prepare smokers to interact with service agencies and/or act as an advocate on their behalf; (9) provide instrumental support such as arranging transportation; (10) actively intervene to resolve barriers to basic needs solutions; (11) oversee follow-up of problem solving actions; and (12) review progress made towards resolving unmet basic needs and adapt solutions accordingly.
15959097|NCT03194945|Drug|CSII followed by Lina+MET|short-term intensive CSII followed by Linagliptin 5mg qd and Metformin 0.5g bid for 48 weeks
15959098|NCT03194945|Drug|CSII followed by Lina|short-term intensive CSII followed by Linagliptin 5mg qd for 48 weeks
15959099|NCT03194945|Drug|CSII followed by MET|short-term intensive CSII followed by Metformin 0.5g bid for 48 weeks
15959100|NCT03194945|Drug|CSII alone|No OHA is given after short-term intensive CSII
15959101|NCT03194932|Drug|Venetoclax|Venetoclax will be given as oral tablets, which are intended to be swallowed intact and may not to be crushed or otherwise altered for administration, or as an oral suspension for patients who cannot swallow tablets.
15959102|NCT03194932|Drug|Cytarabine|Given intravenously (IV) or intrathecally (IT).
15959103|NCT03194932|Drug|Idarubicin|Given IV.
15959104|NCT03194932|Drug|Intrathecal Triple Therapy|Given IT.
15959105|NCT03194932|Drug|Azacitidine|Given IV.
15959106|NCT03194919|Other|Endre: a digital smoking cessation counsellor|A comprehensive 25-session intervention delivered by web, e-mail and SMS-text messages. Sessions are released one each day for 18 days, and then every second day for 14 days. Intervention content is tailored based on user input and individual usage pattern. The intervention is described in detail in Holter, Johansen & Brendryen (2016). How a fully automated eHealth program simulates three therapeutic processes: A case study. Journal of Medical Internet Research 18 (6).
15959107|NCT03194906|Drug|Memantine|Medication dosing will be overseen by one of the study neurologists, with step-wise dose reductions (5 mg intervals) allowable in the case of side effects.
15959108|NCT03194906|Other|Placebo|A placebo that appears exactly like the study drug, memantine, will be given in a manner identical to the study drug.
15959109|NCT03194906|Other|Cognitive Assessment|Cognitive and neurologic examinations will be conducted to assess cognitive, social, quality of life, and neurological outcomes associated with memantine will be completed at baseline prior to medication start, and at 6 weeks (end of radiation therapy), 12 weeks (discontinuation of study medication or placebo), and one year post radiation therapy.
15959110|NCT03194893|Drug|Alectinib|Alectinib capsules 600 mg twice a day (BID) orally until no further clinical benefit is to be expected, unacceptable toxicity, availability of commercial supply, withdrawal of consent, or death, whichever occurs first.
15959111|NCT03194893|Drug|Crizotinib|Crizotinib capsules 250 mg BID orally until no further clinical benefit is to be expected, unacceptable toxicity, availability of commercial supply, withdrawal of consent, or death, whichever occurs first.
15959112|NCT03194880|Device|AlereCOMBO and Alere q Detect|"The feasibility assessment will comprise of two components:
~User's perspective: A questionnaire will be developed and used to assess the level of satisfaction among community health workers performing the two new tests, using a 5 point Likert scale. We will assess the training and manual, the use of the test, the user's confidence, troubleshooting and technical support components and resolving problems.
~The laboratory component: For each test we will evaluate:
~The percentage of assays completed
~The percentage of assays incomplete (i.e. invalid result on two attempts)
~Reasons for incomplete assays, e.g.
~The sample could not be delivered to the strip or cartridge correctly
~Invalid control
~Results could not be interpreted
~Others"
15959113|NCT03194867|Drug|Isatuximab SAR650984|"Pharmaceutical form: solution for infusion
~Route of administration: intravenous"
15959114|NCT03194867|Drug|Cemiplimab REGN2810|"Pharmaceutical form: solution for infusion
~Route of administration: intravenous"
15959115|NCT03194854|Behavioral|Fun For Wellness (FFW)|FFW consists of videos, games, and content teaching 14 skills to support seven drivers of change that promote well-being in I COPPE domains. The drivers form the acronym BET I CAN, which stands for: Behaviors, Emotions, Thoughts, Interactions, Context, Awareness, and Next Steps. B teaches basics of habit formation, including antecedents, behaviors, and consequences and techniques like goal setting, behavior tracking and rewards. E teaches how to build positive emotions and cope with negative ones. T teaches lessons from cognitive behavioral therapy. I builds communication skills such as empathy, listening and assertiveness. C teaches how to create healthier environmental contexts. A aims to increase insight. N emphasizes the need to make plans and anticipate barriers.
15959116|NCT03194841|Other|Heart failure application|A mobile phone application that allowed for input of physiologic data, qualitative question input and education retrieval along with SMS use.
15959117|NCT03194828|Behavioral|Medication reminder|Using the real-time data capture of the electronic device, an automated voice call or text message will be sent to active arm participants only when a missed dose is determined
15959118|NCT03194828|Behavioral|Medication monitoring only|Patients will use an electronic medication monitoring device to record their actual medication use
15959119|NCT03194815|Drug|Intravenous immunoglobulin|This is a blood product containing antibodies from thousands of healthy donors.
15959120|NCT03194815|Drug|Placebo|This is the control, or sham, treatment
15959121|NCT03194815|Drug|Rituximab|Rituximab is a type of biological therapy. It removes B-cells and helps to reduce the inflammation
15959124|NCT03194789|Device|Footwear Generated Bio-Mechanical Manipulation (using shoes with pertupods) along with Traditional Pelvic Floor Therapy|Participants will have FGBMM using shoes with pertupods along with traditional pelvic floor therapy over the course of six months. This will include five sessions of gait assessment and re-calibration with daily at home exercise with the device (shoes) over the course of six months. Along with that, participant will receive traditional pelvic floor therapy of six sessions, up-to one sessions every alternate week. This will involve exercise and modalities as decided by medical providers and therapists. Participants will also have a home exercise program prescribed along with each session and for the remainder of six months.
15959125|NCT03194789|Other|Traditional Pelvic Floor Therapy|Participant will receive traditional pelvic floor therapy of six sessions, up-to one sessions every alternate week. This will involve exercise and modalities as decided by medical providers and therapists. Participants will also have a home exercise program prescribed along with each session and for the remainder of six months.
15959126|NCT03194776|Drug|LLG783|LLG783 concentrate solution for infusion/injection suitable for i.v. administration as well as s.c. administration.
15959127|NCT03194776|Drug|Placebo|Placebo to LLG783 concentrate solution for infusion/injection suitable for i.v. administration as well as s.c. administration.
15959128|NCT03194763|Diagnostic Test|coronary angiography|computed tomography acquisitions performed on a revolution CT
15959129|NCT03194750|Other|Share ultrasound measurement of IVC collapsibility to Nephrology Attending|Nephrology attending will be provided with the respiratory variability of IVC diameter as a percent, in addition to a predefined cutoff for responsiveness to volume resuscitation of < 12%. The information will be provided before rounds and before the attending sets the fluid removal goals on dialysis for that day.
15959130|NCT03194750|Other|Do not share ultrasound measurement of IVC collapsibility to Nephrology Attending|Respiratory variability of IVC diameter will be measured, but the measurement result will not be shared with the treating team.
15959131|NCT03194737|Device|UroLift System Procedure|Minimally invasive procedure in patients with acute urinary retention secondary to BPH.
15959132|NCT03194724|Other|Vitamin A supplementation|Bi annual vitamin A supplementation programme
15959133|NCT03194711|Device|BVS implantation|BVS implantation using conventional semicompliant or non-compliant balloon
15959134|NCT03194698|Device|Intense Pulsed Light Treatment (IPL)|IPL is a high-intensity light source consisting of visible light in the wavelength range of 515-1200 nm, that is aimed at the eyes. Treatments are spaced four to six weeks apart for a total of 4 treatments.
15959135|NCT03194698|Procedure|Meibomian Gland Expression|Manual expression of the meibomian glands by placing the thumb against the lid margin and press firmly against the eyeball to determine the percentage of meibomian pores that are blocked. This assessment is performed on both the upper and lower lid of each eye.
15959136|NCT03194685|Drug|FF-10101-01|FF-10101-01 will be administered orally once a day on Days 1-28 of a 28-day cycle. In Phase 1, the dose escalation will proceed until MTD is reached. In Phase 2a, subjects will be randomly assigned to 1 of 3 dose levels in a balanced fashion. The treatment will continue until, intolerable toxicity, or investigation/subject decision.
15959137|NCT03194672|Behavioral|Healthy Adolescent Transitions (HAT) program|"The components of the intervention are described in the arm description.
~The intervention is based upon the theoretical framework of behavioral economics, which suggests that low intensity nudges can help recipients accomplish their own goals. All components of the intervention are voluntary; some participants may wish to discuss all components, while other participants may wish to discuss selected components consistent with their priorities."
15959138|NCT03194659|Dietary Supplement|Choline|Choline chloride is a water soluble choline salt that will be provided in a juice solution to participants to be consumed daily. The intervention will increase dietary choline intake by 500mg/day.
15959146|NCT03194633|Drug|Nifedipine controlled-release tablets(Nifedipine GITS, ADALAT, BAYA1040)|Nifedipine GITS 60 mg (once per day)
15959147|NCT03194620|Other|Thearubigins|Single oral intake of 94.9 mg of therubigins (isolated from black tea) in a flavanol-free, fruit flavored, non-dairy drink
15959148|NCT03194620|Other|Theaflavins|Single oral intake of 120 µmol of an equimolar mixture of theaflavins (isolated from black tea) in a flavanol-free, fruit flavored, non-dairy drink. The theaflavin mix includes theaflavin, theaflavin-3-gallate and theaflavin-3,3'-gallate
15959149|NCT03194620|Other|Procyanidin Dimer B2 (DB2)|Single oral intake of 120 µmol of Procyanidin Dimer B2 (DB2) (isolated from Theobroma cacao) in a flavanol-free, fruit flavored, non-dairy drink.
15959150|NCT03194620|Other|(-)-Epigallocatechin-3-O-gallate (EGCG)|Single oral intake of 120 µmol of (-)-Epigallocatechin-3-O-gallate (EGCG)(isolated from green tea) in a flavanol-free, fruit flavored, non-dairy drink.
15959151|NCT03194620|Other|(-)-Epicatechin-3-O-gallate (ECG)|Single oral intake of 120 µmol of (-)-Epicatechin-3-O-gallate (ECG) (isolated from green tea) in a flavanol-free, fruit flavored, non-dairy drink.
15959152|NCT03194620|Other|(-)-Epicatechin (EC)|Single oral intake of 120 µmol of (-)-Epicatechin (EC) (isolated from green tea) in a flavanol-free, fruit flavored, non-dairy drink.
15959153|NCT03194620|Other|(-)-Epigallocatechin (EGC)|Single oral intake of 120 µmol of (-)-Epigallocatechin (EGC) (isolated from green tea) in a flavanol-free, fruit flavored, non-dairy drink.
15959286|NCT03193489|Other|Control Parkinson group|No treatment.
15959158|NCT03194594|Drug|Ketamine Hydrochloride, dexamethasone, and combination of two drugs|After receiving by IRB approval and obtaining informed consent from patients, 93 patients who were aged between 18 and 70 years old and classified as American Society of Anesthesiologists (ASA) classes I and II. Afterward, the patients are randomly (sealed envelopes) allocated into one of three treatment; Group K (n = 31) receives a single dose of ketamine 0.5 mg/kg i.v. plus 2 ml normal saline, Group D (n = 31) receives dexamethasone 0.5 mg/kg i.v. and a maximum dose of 8 mg plus 2 ml saline, and Group KD (n = 31) receiveds ketamine 0.5 mg/kg i.v. and dexamethasone 0.5 mg/kg i.v. at 5 minutes after the induction of anesthesia in a double-blinded method.
15959159|NCT03194581|Device|Cerebral oxygenation|Evaluate cerebral oxygenation using normoxic challenges
15959160|NCT03194568|Device|Anterior Vertebral Tether|Vertebral body tethering through anterior thoracoscopic approach under general anesthesia and fluoroscopic guidance.
15959161|NCT03194555|Drug|Low-Dose Naltrexone and Acetaminophen Combination|Twice daily
15959162|NCT03194555|Drug|Placebo|Twice daily
15959163|NCT03194542|Drug|Luspatercept|Luspatercept is a recombinant fusion protein consisting of a modified form of the extracellular domain of the human active in receptor type IIB linked to the IgG1 Fc domain. Luspatercept, through a mechanism of action different from erythropoietin, works to correct ineffective erythropoiesis by promoting late-stage maturation of erythroblasts.
15959164|NCT03194529|Biological|FMT|Fecal Microbiota Transplantation, single dose, 50g of stool, delivered via standard of care upper endoscopy into jejunum.
15959165|NCT03194516|Other|Surveillance|The investigators propose an 8-week ketogenic diet intervention with pre-/post-intervention assessment of serum and tissue metabolic and inflammatory biomarkers, including metabolomics analysis, among a sample of 12 overweight or obese prostate cancer patients on active surveillance. There will be no randomization; all patients will receive the diet intervention.
15959166|NCT03194503|Device|VL Coaching training using C-MAC video laryngoscope|"Each neonatology attending providers will receive a video laryngoscopy coaching training using a C-MAC video laryngoscope and an intubation training manikin available at each site by a site leader. During the training, site leader will act as a trainee confederate, and each neonatology attending provider will be trained to coach a trainee utilizing video images from C-MAC video laryngoscope and a cognitive aid with standardized language in a laminated card. This training part typically takes approximately 15-30 minutes including consenting process.
~Each site leader will be trained by PI or PI's designee using remote simulation. In this remote simulation, each site leader will coach an actor at the Children's Hospital of Philadelphia (CHOP) using a profile video image and C-MAC video laryngoscopy image through CHOP approved video conferencing software. A standardized language will be taught to each site leader with a cognitive aid (laminated card)."
15959167|NCT03194490|Other|combined intervention group|The combined intervention group received the cervical passive mobilization, stretching, and home program (Stretching and ROM exercise).Stretching, cervical passive mobilization, and range of motion: The manual therapy was conducted by a physical therapist who has licensed from the California Board of Physical Therapy. The cervical passive mobilization were selected by the physical therapist based on the participant's condition. Stretching techniques were performed in the combined intervention group for 30 seconds and repeated 3 times twice a week in the following order on the following muscles: anterior, middle and posterior scalene, upper fibers of trapezius, pectoralis minor and interspinous muscles .AROM Exercise were performed 10 repetitions 3-4 times daily. The ACROM exercise consisted of the subject placing fingers over the manubrium bone and placing chin on the fingers. The subject was then instructed to rotate to one side as far as possible and return to neutral.
15959168|NCT03194490|Other|The standard intervention|"The standard intervention group will receive cervical mobilization and home program (ROM exercises).
~Cervical mobilization and range of motion: The manual therapy was conducted by a physical therapist who has experience in manual therapy and is licensed from the California Board of Physical Therapy. The manual therapy intervention will consist of Passive Accessory Intervertebral Movements (PAIVMs). The nature of PAIVMs techniques was selected by the physical therapist based on the participant's condition.
~Active Cervical Range of Motion Exercises (ACROM) were performed 10 repetitions 3-4 times daily. Subjects were advised to maintain their usual activity within the limits of pain. The ACROM exercise consisted of the subject placing fingers over the manubrium bone and placing chin on the fingers. The subject was then instructed to rotate to one side as far as possible and return to neutral ."
15959169|NCT03194477|Behavioral|Mobile-enhanced Engagement Intervention|Mobile phone based enhanced case management intervention for HIV positive & HIV negative young Black men who have sex with men.
15959170|NCT03194464|Other|submaximal exercise (grip)|participants perform repeated gripping with visual feedback to task failure
15959171|NCT03194451|Other|non-interventional study|teeth collection
15959172|NCT03194438|Behavioral|Urban Zen Integrative Therapy (UZIT)|Multi-modal components integrative therapy program (UZIT) that includes essential oil, gentle body movement, body-awareness meditation, and Reiki.
15959173|NCT03194425|Diagnostic Test|Pelvic floor EMG|Define pelvic floor EMG template measured by probe
15959174|NCT03194412|Dietary Supplement|Diet /nutritional|"• Duration:
~the first stage - 3 months: 12 weeks
~second stage - 3 months: 12 weeks
~Each patient collect a detailed menu of the last two days before making the description. Then the menu is analyzed by a nutrition consultant. The role of nutrition consultant is:
~make a diet modification to include the products recommended in frailty
~modifying eating habits
~The diet modification is mainly focused on adequate supply:
~vitamin D (according to Central Europe guidelines -2013 for seniors)
~protein (according to European Society for Clinical Nutrition and Metabolism (ESPEN recommendations)"
15959175|NCT03194412|Behavioral|Physical activity|"Duration:
~the first stage - 3 months: 12 weeks
~second stage - 3 months: 12 weeks
~Frequency: twice a week
~Duration of each session: 60 minutes
~Worksheets for the elderly with frailty syndrome have been developed:
~resistance exercises and strength training, which aim to improve muscle strength in the limbs
~exercises aimed at improving motor coordination, flexibility and speed
~stretching exercises."
15959176|NCT03194412|Combination Product|Comprehensive therapy|"Combination of special diet for elderly (as in Group 1) and regular physical activity into everyday life of the elderly (as in Group 2)
~Duration:
~the first stage - 3 months- 12 weeks
~the second stage - 3 months- 12 weeks Frequency of physical activity: twice a week Duration of each session: 60 minutes"
15959219|NCT03194074|Drug|Desflurane|In desflurane/remifentanil group, desflurane at end tidal concentration at 0.7~1.0 minimum alveolar concentration (MAC) and remifentanil 0.1-0.3 ug/kg/min are used.
15959177|NCT03194412|Behavioral|Caregivers of elderly|"Group: formal and informal caregivers of elderly with frailty syndrome Materials and Tools: multimedia presentation about frailty prevention and treatment (nutrition, physical activity, dietary supplement diet).
~Duration:
~the first stage - 3 months: 12 weeks
~the second stage - 3 months: 12 weeks
~Frequency: 1 (at the beginning of stage 0, 1 and 2) Duration: 60 minutes"
15959178|NCT03194399|Behavioral|Personalized health care service|Physical activity coaching, other functional outcome observation
15959179|NCT03194386|Other|Reassurance|At the end of cares, before ED discharge, a trained psychologist will conduct a session in order to reassure patients about their future after ED visit.
15959180|NCT03194386|Other|Eye-Movement Desensitization and Reprocessing (EMDR)|At the end of cares, before ED discharge, a trained psychologist will conduct a single EMDR session. Each session may last about 60 minutes
15959181|NCT03194373|Drug|Palbociclib|"Palbociclib (Ibrance) (PO), dose= 125 mg PO daily, days=1-14, cycle length: 21 days
~Maintenance Palbociclib:
~Palbociclib (Ibrance) 125 mg PO daily, days 1-21, cycle length: 28 days"
15959182|NCT03194373|Drug|Carboplatin|Carboplatin (IV), dose= AUC 5, day= 1, cycle length: 21 days
15959183|NCT03194347|Diagnostic Test|molecular genetic analyses|molecular genetic analyses
15959184|NCT03194334|Behavioral|Vegetarian diet|
15959185|NCT03194334|Dietary Supplement|creatine|1g creatine/day
15959186|NCT03194334|Dietary Supplement|Placebo|pills
15959187|NCT03194334|Dietary Supplement|Beta-alanine|0.8g beta-alanine per day
15959188|NCT03194321|Drug|Tacrolimus Extended Release Oral Capsule|Maintenance immunosuppression will consist of tacrolimus extended-release, mycophenolate mofetil 500mg twice daily or mycophenolate sodium 360mg twice daily, and prednisone.
15959189|NCT03194308|Behavioral|PrEP for Safer Conception|Evaluation of uptake of and adherence to PrEP and safer conception strategies including: CHCT, ART for the infected partner, and uptake of contraception for those who decide not to conceive by enrolled women, during periconception and pregnancy follow up.
15959190|NCT03194295|Behavioral|Community Support Intervention Group|This 12-week community support intervention is designed to activate and harness the powerful influences of drug-free family and friends to enhance recovery support and participation in community activities. Addiction Treatment Services (ATS) participants and their CSPs will be directed to participate in recovery-oriented community activities together 2 times per week and work together toward developing regular drug-free social support for the ATS participant. The group provides an opportunity for both the participant and CSP to discuss their experiences participating in the scheduled activities. For those electing not to engage in community activities, problem-solving strategies will be used to remove obstacles to participation, with other group members providing support and encouragement.
15959191|NCT03194295|Behavioral|Substance Use Disorder Educational Group|This 12-week educational group is designed as an attention-control group. Group topics include: 1) definition of substance dependence, 2) the disease model, 3) medical aspects, 4) mood, 5) personality, 6) self-esteem, 7) relapse prevention, 8) HIV/AIDS, 9) anger, 10) negative thinking, 11) nutrition, and 12) assertiveness. Participants will be assigned 2 homework assignments each week based on the topic.
15959192|NCT03194282|Other|insole|The subjects are randomly assigned to assess balance capacity either with or without insole.
15959193|NCT03194269|Device|EARFOLD®|EARFOLD® implant is inserted subcutaneously using the sterile disposable EARFOLD® introducer under local anaesthetic
15959194|NCT03194256|Behavioral|Spectrum Research Cigarettes|Participants will be assigned to either normal nicotine content cigarettes or very low nicotine content cigarettes.
15959195|NCT03194230|Other|With cervical dilatator|Induction of labour by cervical placement of hygroscopic dilators (Dilapan-S Hygroscopic cervical dilator )
15959196|NCT03194217|Drug|BEN-2001|Bavisant dihydrochloride monohydrate for oral use
15959197|NCT03194217|Drug|Placebo|Placebo
15959198|NCT03194204|Drug|Doxycycline Tablets|MMP-3 and MMP-9 will be done with blood samples using ELISA technique CIMT will be done using colored doppler ultrasound
15959199|NCT03194191|Device|Acupuncture needles|The patient will be in a semi recumbent position during needle penetration. Duration of needle insertion: 30 minutes
15959200|NCT03194178|Other|Pierre Robin sequence patients|"4 questionnaires will be completed by the patient :
~Kidscreen 52 (generic quality of life questionnaire)
~Voice Handicap Index : VHI-9i (specific quality of life questionnaire)
~Child Oral Health Impact Profile : COHIP (specific quality of life questionnaire)
~MDI-C (composite depression scale for minors)"
15959201|NCT03194165|Biological|Dolutegravir|Dosage
15959202|NCT03194165|Biological|Raltegravir|Dosage
15959203|NCT03194165|Biological|Rilpivirine|Dosage
15959204|NCT03194165|Biological|Nevirapine|Dosage
15959205|NCT03194165|Biological|Atazanavir|Dosage
15959206|NCT03194165|Biological|Darunavir|Dosage
15959207|NCT03194165|Biological|Ritonavir|Dosage
15959208|NCT03194152|Dietary Supplement|Peanut|Dietary Supplement: Peanut
15959209|NCT03194152|Dietary Supplement|Control|Dietary Supplement: High carbohydrate snacks
15959210|NCT03194139|Drug|GC4711 30 mg IV|GC4711 will be infused IV as a single dose of 30 mg (3 mL GC4711 at 10 mg/mL) in 245 mL normal saline, totaling 250 mL, over a 60-minute period using a programmable pump
15959211|NCT03194139|Drug|GC4711 50 mg IV|GC4711 will be infused IV as a single dose of 50 mg (5 mL GC4711 at 10 mg/mL) in 245 mL normal saline, totalling 250 mL, over a 60-minute period using a programmable pump.
15959212|NCT03194139|Drug|GC4419 45 mg IV|GC4419 will be infused IV as a single dose of 45 mg (5 mL GC4419 at 9 mg/mL) in 245 mL normal (0.9%) saline, totalling 250 mL, over a 60-minute period using a programmable pump.
15959213|NCT03194126|Procedure|Mifepristone + Misoprostol OR oxytocine + laminaria|Three laminaria placed 12 hours prior to administration of misoprostol
15959214|NCT03194126|Procedure|Mifepristone + Misoprostol OR oxytocine|standart support
15959215|NCT03194113|Behavioral|Trauma-focused treatment|Weekly sessions
15959216|NCT03194113|Behavioral|Emotion regulation training|Managing and tolerating negative emotions, e.g. anger, sadness. Weekly sessions; preparatory to Prolonged exposure treatment
15959217|NCT03194113|Behavioral|Intensive Trauma-focused treatment|Intensive version (3 sessions per week) of Trauma-focused treatment
15959218|NCT03194074|Drug|Propofol|In propofol/remifentanil group, propofol at a rate 75~150 µg/kg/min and remifentanil at 0.1-0.3 µg/kg/min are maintained throughout surgery.
15959221|NCT03194061|Drug|Weekly cisplatin|Concomitant weekly cisplatin 35mg/m2 x 4 weeks
15959222|NCT03194048|Other|Functional Chewing Training|"FuCT;
~Family training
~Providing optimal sitting posture for children to support oral sensorimotor functions
~Positioning the food to the molar area during every meal to stimulate lateral and rotational tongue movements
~Massage of the upper and lower gums through the front teeth to molar area
~Chewing training to stimulate lateral and rotational tongue movements
~Gradually increasing the food consistency, for 12 weeks in 5 sets (1 set = 20 min) each day"
15959223|NCT03194048|Other|Classical Oral Motor Exercises|"Classical Oral Motor Exercises;
~Family training
~passive and active lip and tongue exercises, for 12 weeks in 5 sets (1 set = 20 min) each day"
15959224|NCT03194035|Biological|blood sample|Study per and post-exertional changes in proinflammatory biological (IL1, IL6, TNF alpha, HMG beta1 and CRP) and anti inflammatory parameters (IL4, IL10 and IL13, TGF beta, LPS, lipoproteins, lipids) during an ultra endurance race.
15959225|NCT03194022|Other|Blood sample|measurement of electrolytes and blood count
15959226|NCT03194009|Drug|Metformin|The patient will received metformin 1 tablet of 850mg every 12 hrs besides lifestyle modification recommendations
15959227|NCT03194009|Behavioral|Lifestyle intervention|The patient will received recommendations to modify their diet and increase their physical activity every three months towards prevention of diabetes
15959228|NCT03193996|Device|4DCT|4DCT will be used to assess the location of the torn scapholunate interosseus ligament.
15959229|NCT03193983|Procedure|Flaps Coverage|Surgical group will undergo surgical coverage of the fingertip defect by V-Y flap using the skin on the volar aspect of the same finger designed as V shaped then mobilized dorsally to cover the defect and stitches to be Y shaped. Stitches are removed after 2 weeks.
15959230|NCT03193983|Procedure|Occlusive Dressing|Conservative group will undergo minimal trimming of the bone end and an occlusive dressing that is changed on a weekly basis till complete healing of the defect that occurs after 6 weeks.
15959231|NCT03193970|Behavioral|Post-Operative Recovery Registry|Multi-institutional prospective database of patients with bladder cancer undergoing radical cystectomy.
15959232|NCT03193957|Drug|Etanercept|Etanercept PFS and Autoinjector
15959233|NCT03193957|Device|Autoinjector|Autoinjector
15959234|NCT03193944|Drug|D-vitin, soft gelatin capsule (vitamin D3,50000 IU)|Intervention group: The respondents in intervention group will receive 50000 vitamin D for 8 weeks. Plus, brochures and pamphlets related to nutrition and health.
15959235|NCT03193944|Drug|Placebo vitamin D3|vitamin D as a placebo
15959236|NCT03193931|Drug|Pembrolizumab Injection|Pembrolizumab 200 mg q3w i.v. until disease progression or non-tolerable toxicity (maximum 2 years)
15959237|NCT03193931|Drug|Methotrexate Injectable Solution|Methotrexate 40 mg/m2 weekly i.v. until disease progression or non-tolerable toxicity (maximum 2 years)
15959238|NCT03193918|Drug|Crenolanib|Crenolanib continuously on Days 1-28 at 1 of 3 BID doses - 60 mg, 80 mg or 100 mg
15959239|NCT03193918|Drug|Ramucirumab|Ramucirumab IV 8 mg/kg on Days 1 and 15 q28 days
15959240|NCT03193918|Drug|Paclitaxel|Paclitaxel IV 80 mg/m2 on Days 1, 8 and 15 q28 days
15959241|NCT03193905|Procedure|Bairhugger Full Access Underbody Blanket|30 patients undergo new procedure with a Bairhugger Full Access Underbody Blanket
15959242|NCT03193905|Procedure|Cotton blanket - control group|30 patients undergo standard procedure with a cotton blanket
15959243|NCT03193866|Drug|Rituximab|Comparisons of efficacy and safety between rituximab and all other frequently used immunomodulating drugs against multiple sclerosis
15959244|NCT03193853|Drug|Tak-228 & Tak-117|Patients will receive oral TAK-228 and TAK-117 tablets until disease progression.
15959245|NCT03193853|Drug|Cisplatin & Nab Paclitaxel|following Tak-228 & Tak-117 standard nab paclitaxel plus cisplatin infusion for six cycles. Patients who did not progress may continue nab paclitaxel under treating physicians discretion
15959246|NCT03193840|Procedure|posterior wall osteotomy|posterior wall osteotomy is conducted through Kocher-Langenbeck approach.
15959247|NCT03193827|Device|In-line filtration|In-line filtration is used during anesthesia and postoperative 96 hrs in study group to purify endovascular fluids administrations reducing postoperative phlebitis
15959248|NCT03193827|Device|Standard treatment|Patients are treated with standard intravenous solutions and vascular access management
15959249|NCT03193814|Drug|Chemotherapy + Apatinib|chemotherapy regimens could be folfox or folfiri; apatinib 500mg po qd
15959250|NCT03193801|Device|Edwards SAPIEN 3 transcatheter valve, Model 9600TFX|Edwards SAPIEN 3 THV system Model 9600TFX with the associated delivery systems.
15959251|NCT03193788|Drug|pemetrexed|Pemetrexed 500 mg/m2mixed in normal saline 100 mL as a 10 minute IV infusion on day 1 of each 21 day cycle
15959252|NCT03193788|Drug|Folic Acid|folic acid 1000 μg daily orally from 7 days prior to treatment initiation until the end of treatment
15959253|NCT03193788|Drug|Vitamin B12 Injection|vitamin B12 1000 μg IM 7 days prior to treatment initiation and the end of treatment
15959254|NCT03193788|Drug|Dexamethasone|Dexamethasone 4 mg twice orally for 3 days beginning the day before treatment until the end of treatment to minimize cutaneous reactions
15959255|NCT03193775|Biological|HBV vaccine|HBV vaccine which contains Purified HBsAg produced by recombinant DNA technology (Euvax-B, LG Life sciences, Korea) intramuscularly in deltoid region at three different time intervals (0, 1, 6 months).
15959256|NCT03193762|Other|Anxiety VAS|Anxiety will be measure with a 10-points visual analogic scale (VAS)
15959257|NCT03193749|Drug|Amiodarone Hydrochloride|Starting (loading) dose 400 mg PO once a day for 10 days. Maintainance dose 200 mg PO once a day for at least 6 months, up to 24 months
15959258|NCT03193749|Drug|Placebo Oral Tablet|Matching placebo for tablets of 200 mg of Amiodarone
15959259|NCT03193736|Device|MINIject implant|"MINIject implant is used to reduce intra-ocular pressure (IOP) in the eye through a minimally-invasive Glaucoma surgical intervention.
~The intervention is to be performed as stand-alone surgery."
15959287|NCT03193463|Drug|Topotecan (<=8cc)|In predominantly enhancing mass with a volume of 8 cc or less of topotecan administered
15959288|NCT03193463|Drug|Topotecan (>8cc)|In predominantly enhancing mass with a volume of > 8 cc of topotecan administered. Initial rate is 0.834ml/hour with an increase to 1.668 ml/hour at the second infusion
15959289|NCT03193463|Device|Cleveland Multiport Catheter|an investigational device, will be used to deliver the topotecan
15959260|NCT03193723|Procedure|US guided five step field block|"Ultrasound will guide needle insertion in the following layers (except intradermic injection):
~Subdermic infiltration. Approximately 8 milliliters
~Intradermic injection (making of the skin wheal). of approximately 6 milliliters.
~Deep subcutaneous injection. 8 milliliters of the mixture will be injected deep into the subcutaneous adipose
~Subfascial infiltration. Approximately eight milliliters of the anesthetic mixture will be injected immediately underneath the aponeurosis of the external oblique.
~Pubic tubercle and hernia sac injection. Occasionally, infiltration of ten milliliters of the mixture at the level of the pubic tubercle, around the neck and inside the indirect hernia sac"
15959261|NCT03193723|Procedure|Spinal anesthesia|Spinal anesthesia will be administered in sitting position, with 25 gauge Quincke spinal needle in L3-L4 intervertebral space, under all aseptic precautions and local infiltration, with 3.0 ml of 0.5% bupivacaine (heavy) after ensuring free, clear and adequate flow of cerebrospinal fluid. After giving spinal anesthesia, patient will be made to lie supine.
15959262|NCT03193710|Drug|Propofol|Propofol will be used for anesthesia maintenance in the total intravenous anesthesia group.
15959263|NCT03193710|Drug|Sevoflurane|Sevoflurane will be used for anesthesia maintenance in the inhalation anesthesia group.
15959264|NCT03193710|Drug|Remifentanil|Remifentanil will be used for analgesia in both groups.
15959265|NCT03193697|Device|cemented SPII prosthesis|Old patients with unstable intertrochanteric fractures underwent total hip arthroplasty. Forty-four patients in the control group received a cemented SPII prosthesis (Link, Germany).
15959266|NCT03193697|Device|cementless Wagner prosthesis|Old patients with unstable intertrochanteric fractures underwent total hip arthroplasty. Forty-two patients in the trial group received cementless Wagner prosthesis (Zimmer, USA).
15959267|NCT03193684|Drug|Dapagliflozin 10mg|subjects will receive daily dose of 10 mg dapagliflozin for 3 months
15959268|NCT03193684|Drug|Control|Placebo
15959269|NCT03193671|Diagnostic Test|Diagnosis|Improving diagnosis
15959270|NCT03193658|Procedure|Thoracolumbar Interfascial Plane (TLIP) block|"A 10 cm 21G Stimuplex needle (Braun Medical Inc, Bethlehem, PA, USA) will be inserted in a lateral-to-medial orientation with an approximate angle of 30 degrees to the skin. The needle will then be advanced under real-time in-plane ultrasound guidance through the belly of the LG towards the MF. The needle tip will be directed towards the LG/MF interface deep to the midpoint then a total volume of 20 ml of Bupivacaine 0.25% will be incrementally injected with intermittently repeated negative aspiration. Anterior spread of local anesthetic will be viewed as favourable.
~The same procedure will be repeated on the left side. The patient will then be disinfected and draped and surgery will be allowed to proceed normally."
15959271|NCT03193658|Drug|I.V drug based multimodal approach|A base low dose opioid of 5mg morphine I.V every 8 hours. Rescue analgesia will be given to the patient if reported a VAS equal or more than 4 in the form of I.V morphine in 2.5mg increments till VAS returns to 4 or less in addition to 1 gm of oral acetaminophen every 6 hours
15959272|NCT03193645|Drug|Degarelix|Injection
15959273|NCT03193632|Diagnostic Test|US Muscle layer thickness (MLT) estimation|"Three measurements will be made at each of three sites; mid-upper arm, forearm and thigh anteriorly and the mean value will be calculated. Measurement sites will be marked with indelible ink to ensure day-to-day consistency.
~Thigh: MLT of the quadriceps femoris muscle (M. Vastus intermedius and M. rectus femoris) will be assessed bilaterally
~Mid-upper arm: Muscle layer thickness will be measured over the biceps,midway between the tip of the acromion and the tip of the olecranon
~Forearm: A point midway between the antecubital skin crease and the ulnar styloid was marked and muscle thickness down to the interosseus membrane"
15959274|NCT03193632|Diagnostic Test|REE estimation by indirect calorimetry|REE will be calculated using indirect calorimetry via metabolic module on General Electric ventilator (Engstrom Carestation and Carescape R860, GE Health care, USA) All indirect calorimetric measurements will be done using standardized technique. Gas calibration will be performed before each measurement, and the measurements will last for at least 30 minutes. Measurements will be taken with the patient lying supine and ventilator settings left unchanged for at least 60 minutes ahead of indirect calorimetry. The REE will be calculated during the first 24 hours of admission to ICU.
15959275|NCT03193619|Device|PTA (UltraScore Focused Force PTA Balloon)|"Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough.
~The UltraScore Focused Force PTA balloon through the blood vessel to the narrowed area to be treated."
15959276|NCT03193606|Other|nano silver fluoride solution|prepared Nano-silver fluoride could have the capability to arrest caries. As its Nano silver particles have an antimicrobial activity against Mutans Streptococci and Lactobacilli; the main pathogens involved in the development of carious lesions. In addition, its fluoride component is well known to enhance remineralization and inhibit bacterial activity. So, Nano silver fluoride could be a promising solution to combat residual bacteria in tooth cavity with effective remineralization potential on remaining carious dentin
15959277|NCT03193593|Drug|Placebo|Placebo- Single injection of saline into Pectoralis Muscle
15959278|NCT03193593|Drug|EB-001|Single injection of EB-001 into Pectoralis Muscle
15959279|NCT03193580|Device|Anodal Conventional tDCS|tDCS will be applied for 20 minutes at 1milliamp while participants are performing a fine motor task. The current will be set at 1milliamp, stimulation will be ramped up over 30 seconds and ramped down over 30 seconds.
15959280|NCT03193580|Device|Anodal High Definition tDCS|HD-tDCS will be applied for 20 minutes at 1milliamp while participants are performing a fine motor task. The current will be set at 1milliamp, stimulation will be ramped up over 30 seconds and ramped down over 30 seconds.
15959281|NCT03193580|Device|Sham tDCS|tDCS will be applied for 1 minutes at 1milliamp while participants are performing a fine motor task. The current will be set at 1milliamp, stimulation will be ramped up over 30 seconds and ramped down over 30 seconds.
15959282|NCT03193567|Biological|HEKT cell|3 cycles of HEKT cell treatment
15959283|NCT03193502|Drug|rivaroxaban|rivaroxaban
15959284|NCT03193489|Other|Follow-up|
15959285|NCT03193489|Other|Post-treatment control|After 3 weeks of intensive treatment, no special exercises are performed as a control.
15959290|NCT03193463|Diagnostic Test|Magnetic Resonance Imaging (MRI)|to monitor the infusion of topotecan into the tumor
15959291|NCT03193463|Drug|Lower Does Topotecan|Rate for non-enhancing tumors has an initial dose of 0.29ml/hour
15959292|NCT03193450|Behavioral|telephone-based re-education|Patients will receive a repeated instruction by telephone in terms of both calling and message at the forth, seventh, tenth day after the start of treatment.
15959293|NCT03193450|Behavioral|First education at the clinic|Patients will receive an instruction card about the drug administration at the clinic by doctors.
15959294|NCT03193437|Drug|Open Label Selinexor|Selinexor 40 mg oral tablets will be administered twice weekly, either on Monday/Wednesday, Tuesday/Thursday, Wednesday/Friday, Thursday/Saturday, or Friday/Sunday in a 3-weeks-on and 1-week-off schedule.
15959295|NCT03193424|Drug|Apatinib|Subjects were randomly divided into two groups,A group:apatinib 500mg/d,po,qd, Docetaxel 75 mg / m2 was administered on day 1 repeated every 21 days until progressive Disease(PD) . B group:Docetaxel 75 mg / m2 was administered on day 1 repeated every 21 days until progressive Disease(PD) .
15959296|NCT03193411|Device|Visumax femtosecond laser|
15959297|NCT03193411|Device|Moria M2 microkeratome (MK)|
15959298|NCT03193398|Drug|BTRX-246040 oral capsule(s)|BTRX-246040 administered once daily to patients with MDD for 8 weeks
15959299|NCT03193398|Drug|Placebo oral capsule(s)|administered once daily to patients with MDD for 8 weeks
15959300|NCT03193385|Procedure|closed reduction|Closed reduction is where the thigh bone is placed into the socket without any surgical incision being made. This is more likely to be performed in a child under the age of four year. The femoral head is gently manipulated into the socket, whilst the child is under anaesthetic. Once the femoral head is in place, a hip Spica is applied and can remain in place for up to three months to maintain the hip in the correct position. This allows time for healing and for the socket and the thigh bone to mould together as a joint.
15959301|NCT03193372|Drug|Azelaic Acid (Finacea Foam, BAY39-6251)|Finacea Foam, Active substance Azelaic acid
15959302|NCT03193359|Biological|botulinum toxin Type A|Botulinum toxin Type A (BOTOX®) IM 155U to 195U injections in head/neck areas.
15959303|NCT03193346|Biological|botulinum toxin Type A|Botulinum toxin Type A (BOTOX®) 155U to 195U IM injections in head/neck areas.
15959304|NCT03193346|Drug|placebo (sodium chloride 0.9 mg)|Placebo matching BOTOX® [Sodium chloride 0.9 mg] IM injections in head/neck areas.
15959305|NCT03193333|Drug|PRO-122|Posology: 1 drop every 12 hours for 90 days
15959306|NCT03193333|Drug|Timolol eye drops|1 drop every 12 hours for 90 days
15959307|NCT03193333|Drug|Dorzolamide-Timolol Ophthalmic|1 drop every 12 hours for 90 days
15959308|NCT03193333|Drug|Brimonidine Ophthalmic Solution|1 drop every 12 hours for 90 days
15959309|NCT03193333|Other|Placebo1|1 drop of each dropper bottle every 12 hours for 90 days
15959310|NCT03193333|Other|Placebo 2|1 drop of each dropper bottle every 12 hours for 90 days
15959311|NCT03193333|Drug|Krytantek|Posology: 1 drop every 12 hours for 90 days
15959312|NCT03193320|Other|Fluid therapy protocol|Only ringer lactate (RL solution will be used). 1. Fluid loading at induction with 500 ml of ringer lactate solution will be given to some groups. 2. Base infusion rate varies according to group. 3. Fluid challenges - infusion of 250 ml over 5 min, a hemodynamic parameter specific to each group will be monitored for 10 min after the end of infusion to look for changes. Patients who do not respond to four (4) fluid challenges (volume infused 1000 ml) will be excluded.
15959313|NCT03193307|Drug|Microgynon|Run in period & Treatment Period
15959314|NCT03193307|Drug|BI 409306|Day 18 & 29 (Treatment Period)
15959315|NCT03193294|Diagnostic Test|Stratified medicine involving a diagnostic intervention|Adjunctive tests of coronary artery function at the time of invasive coronary angiography. Diagnostic groups: stable coronary syndromes in patients with no-obstructive coronary artery disease including the following sub-groups (coronary artery vasospasm, microvascular spasm, impaired vasorelaxation due to (1) endothelial dysfunction and/or (2) non-endothelial dysfunction, or unaffected (normal test results). Medical management is linked to contemporary clinical guidelines for the management of patients with stable coronary artery disease (European Society of Cardiology (2013)).
15959316|NCT03193281|Drug|Dasatinib|"In order to test the study hypothesis patients need to stay on dasatinib (Sprycel) treatment for the first 12 months of the study (Stage 1).
~Patients who do not reach MR3.0 at 12 months will remain on dasatinib treatment."
15959317|NCT03193281|Drug|Imatinib|Patients who reach MR3.0 at 12 months (and the result is confirmed at 13 months) will switch to imatinib (Imatinib-AFT) treatment.
15959318|NCT03193268|Other|Single-blind RTC of PD patients|The groups participate in observation for 5 weeks. Two groups take part in a motion therapy over the 5-week period.
15959319|NCT03193268|Other|cycling|Patients must undergo a daily exercise cycle of 1 hour during the intervention
15959320|NCT03193255|Device|OPHTECS cleadew GP|Povidone-iodine based disinfecting solutions for rigid contact lenses
15959321|NCT03193242|Other|Electronic Asthma Management System: eAMS|"Electronic Asthma Management System: eAMS Intervention
~eAMS consists of simple questionnaire completed either through an app on a patient's smartphone or tablet computer, a computerized clinical decision support system which then processes these data to produce a set of asthma care recommendations for the clinician, and a printable asthma action plan that is given to patients. eAMS will also provide access to a patient-oriented asthma management tool called Breathe."
15959322|NCT03193229|Behavioral|MapTrek|The objective of the study is to provide an inexpensive and scalable m-health tool to increase both volume and intensity of physical activity and reduce sedentary behavior in patients at risk for or already diagnosed with pre-diabetes.
15959323|NCT03193229|Device|Fitbit|Fitbit
15959324|NCT03193216|Drug|Alginates|Liquid Alginate therapy will be added to twice daily PPI regimen. Patients will be asked to take the alginate solution four times daily (following meals and at bedtime) at 10ml/dose.
15959325|NCT03193203|Drug|Etanercept|50 mg/mL PFS and AI
15959326|NCT03193190|Drug|Nab-Paclitaxel|Nab-Paclitaxel will be administered as per the schedule specified in the respective arm.
15959327|NCT03193190|Drug|Gemcitabine|Gemcitabine will be administered as per the schedule specified in the respective arm.
15959328|NCT03193190|Drug|Oxaliplatin|Oxaliplatin will be administered as per the schedule specified in the respective arm.
15959329|NCT03193190|Drug|Leucovorin|Leucovorin will be administered as per the schedule specified in the respective arm.
15959330|NCT03193190|Drug|Fluorouracil|Fluorouracil will be administered as per the schedule specified in the respective arm.
15959331|NCT03193190|Drug|Atezolizumab|Atezolizumab will be administered as per the schedule specified in the respective arm.
15959332|NCT03193190|Drug|Cobimetinib|Cobimetinib will be administered as per the schedule specified in the respective arm.
15959333|NCT03193190|Drug|PEGPH20|PEGPH20 will be administered as per the schedule specified in the respective arm.
15959334|NCT03193190|Drug|BL-8040|BL-8040 will be administered as per the schedule specified in the respective arm.
15959335|NCT03193190|Drug|Selicrelumab|Selicrelumab will be administered as per the schedule specified in the respective arm.
15959336|NCT03193190|Drug|Bevacizumab|Bevacizumab will be administered as per the schedule specified in the respective arm.
15959337|NCT03193190|Drug|RO6874281|RO6874281 will be administered as per the schedule specified in the respective arm
15959338|NCT03193190|Drug|AB928|AB928 will be administered as per the schedule specified in the respective arm.
15959339|NCT03193190|Drug|Tiragolumab|Tiragolumab will be administered as per the schedule specified in the respective arm.
15959340|NCT03193190|Drug|Tocilizumab|Tocilizumab will be administered as per the schedule specified in the respective arm.
15959341|NCT03193177|Other|the 21-day fasting-like diet|a fasting-like diet with 400 KJ energy intake per day for 21 days
15959342|NCT03193164|Device|Neuromuscular Electrical Stimulation|The patient will be positioned on a headboard at 30° in the decubitus position with the limbs raised to 20°. The location of the electrical current will be cleared with trichotomy when necessary. Adhesive electrodes 90 x 50 mm will be positioned in the gastrocnemius. The stimulator device will be the Neurodyn II (Ibramed, Sao Paulo, Brazil) to provide symmetrical biphasic pulses of 50 Hz, 250 µsec pulse duration, 2 seconds on (1 second of time of rise and 1 second of time of decay), and 5 seconds of rest during 30 minutes at an intensity capable of generating visible contractions and articular motion.
15959343|NCT03193164|Other|Decubitus Position with the limbs raised to 20º|The patient position will be the same used for intervention protocol (headboard to 30°, decubitus position with the limbs raised to 20°) for 30 minutes, without NMES.
15959344|NCT03193151|Procedure|liver biopsy|5 mm fragment of liver transplant biopsy taken for clinical indication
15959345|NCT03193138|Drug|Hormonal therapies: G03, H01C and L02 in the ATC classification|Hormonal therapies including all therapies classified G03, H01C and L02 in the ATC classification
15959346|NCT03193125|Dietary Supplement|L-Carnitine|500 mg tablets of L-Carnitine taken 3 times daily before meals.
15959347|NCT03193125|Dietary Supplement|Placebo|500 mg tablets of L-Carnitine taken 3 times daily before meals.
15959348|NCT03193112|Drug|Agomelatine 25 MG Oral Tablet|We will treat our patients with Agomelatine tablet of 25 mg.
15959349|NCT03193099|Other|Brain imaging|Volume, DWS and DTI
15959350|NCT03193099|Other|Neurological assessments|UHDRS
15959351|NCT03193099|Behavioral|Psychological assessments|STAI (Spielberger state and Trait Anxiety Inventory) A and B, BDI-II (Beck Depression Inventory), MINI (Mini-International Neuropsychiatric Interview) and MINI-SEA (mini Social cognitive and Emotional Assessment)
15959352|NCT03193099|Behavioral|Behavioural assessments|Computerized game
15959353|NCT03193086|Drug|Alemtuzumab|Alemtuzumab is administered to eligible patients in accordance with established treatment regimes. Initially 60 mg of alemtuzumab is injected intravenously over the course of 5 days. The first treatment series is followed by the injection of 36 mg of alemtuzumab over the course of 3 days 12 months later. During both drug interventions, the transient exacerbation in disease severity is alleviated by concomitant steroid therapy.
15959354|NCT03193073|Diagnostic Test|detailed echocardiography|Detailed Echocardiography including ejection fraction, interventricular septum thickness, posterior wall thickness, left ventricular end -diastolic and end- systolic diameter and left ventricular mass index will be correlated with body surface area for both groups serum FGF-23
15959355|NCT03193073|Diagnostic Test|serum fibroblast growth factor-23|serum levels of FGF-23
15959356|NCT03193073|Diagnostic Test|flow mediated dilatation of forearm|superficial sonar assess the diameter of brachial vessel on exposure to stress
15959357|NCT03193047|Drug|bempedoic acid 180mg|Daily bempedoic acid 180mg tablet in addition to monthly PCSK9i (evolocumab) background therapy
15959358|NCT03193047|Other|placebo|Daily matching placebo tablet in addition to monthly PCSK9i (evolocumab) background therapy
15959359|NCT03193047|Drug|evolocumab|Monthly PCSK9i (evolocumab) background therapy
15959360|NCT03193034|Device|Cementless Total Knee Arthroplasty|Patients will undergo a primary total knee replacement using the configuration of the ATTUNE Cementless knee (CR RP)
15959361|NCT03193021|Device|Cardiva Mid-Bore VVCS|The device will be used to close all femoral venous access sites at the end of the case, which range from 3 - 4 access sites per patient.
15959362|NCT03193021|Other|Manual compression|Manual compression will be used to achieve hemostasis in all femoral venous access sites when the sheaths are pulled, which range from 3-4 access sites per patient.
15959363|NCT03192995|Drug|lorcaserin|lorcaserin 20 mg tablet
15959364|NCT03192995|Drug|Placebo Oral Tablet|placebo 20 mg. tablet
15959365|NCT03192982|Device|A-V impulse 6000 Series|foot pad and pump
15959366|NCT03192982|Device|Standard treatment (compression)|Short-stretch bandage from toes and up yo the upper thigh 40 mm Hg
15959367|NCT03192969|Drug|Abatacept|Abatacept subcutaneous injection, 125 mg/prefilled syringe (125 mg/mL)
15959368|NCT03192969|Other|Placebo|Placebo for abatacept for subcutaneous injection in 1 mL pre-filled syringes
15959369|NCT03192969|Drug|Glucocorticoid Treatment|Glucocorticoid taper (up to 52-week or 28-week of oral prednisone/prednisolone)
15959370|NCT03192956|Other|No active intervention|No active intervention is performed
15959371|NCT03192943|Drug|BMS-986205|Specified dose on specified days
15959372|NCT03192943|Biological|Nivolumab|Specified dose on specified day
15959373|NCT03192930|Other|Hyperbaric exposure|Hyperbaric exposure 4 ATA for 36 hours followed by 70 hours decompression
15959374|NCT03192917|Procedure|Low intensity extracorporeal shock wave treatment (LI-ESWT)|Shock wave treatment with 3000 Hz for 10 min on the penile shaft. This will be done one time a week for five weeks.
15959413|NCT03192618|Procedure|adjuvant transarterial chemoinfusion (TAI)|transarterial chemoinfusion (TAI) with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
15959375|NCT03192917|Procedure|Low intensity extracorporeal shock wave treatment (LI-ESWT) sham|A specialized cap can be applied to the chock wave device, which disallow shock waves to transmit through the unit.
15959376|NCT03192904|Device|Energy Instruments|Energy Instruments, including electrocautery, harmonic scalpel and LigaSure.
15959377|NCT03192904|Device|Stapling Device|Stapling Device, including linear stapler and curved stapler.
15959378|NCT03192891|Diagnostic Test|Stress cardiac magnetic resonance (CMR) perfusion imaging|Gadolinium-enhanced stress CMR perfusion imaging is a tool increasingly used for the risk assessment and diagnosis of coronary artery disease.
15959379|NCT03192878|Drug|Infliximab|infliximab biosimilar
15959380|NCT03192865|Procedure|diaphragmatic assessment using ultrasounds.|A diaphragmatic assessment will be performed using ultrasound. This is a pain free assessment. This assessment is commun in our unit after arthroscopic shoulder surgery.
15959381|NCT03192852|Other|dental bleaching|dental bleaching can be achieved with light, light+ peroxide carbamide gel, or only with peroxide carbamide gel
15959382|NCT03192852|Procedure|Gingivoplasty|gengivoplasty will be realized to in illuminated tissue an no illuminated tissue to morphometrically evaluate the tissue
15959383|NCT03192839|Other|Low dose PUFA|Low dose PUFA
15959384|NCT03192839|Other|High dose PUFA|High dose PUFA
15959385|NCT03192839|Other|Placebo|Placebo
15959386|NCT03192826|Drug|Brinzolamide/Brimonidine FC|1 drop of Brinzolamide/Brimonidine FC 1 hour before capsulotomy
15959387|NCT03192826|Drug|Brimonidine 0.2%|1 drop of Brimonidine 0.2% 1 hour before Nd-YAG capsulotomy
15959388|NCT03192826|Drug|Artificial tears|1 drop of artificial tears 1 hour before Nd-YAG capsulotomy
15959389|NCT03192813|Device|Symetis ACURATE neo™ transfemoral TAVI system|Symetis ACURATE neo™ transfemoral TAVI system: Support frame made of nitinol, supra-annular processed tri-leaflet porcine pericardial valve and an outer skirt to mitigate paravalvular regurgitation (manufactured by Symetis SA, Ecublens, Switzerland).
15959390|NCT03192813|Device|Medtronic CoreValve Evolut R TAVI System|Medtronic CoreValve Evolut R Transcatheter Aortic Valve Implantation (TAVI) System (or any future CE-marked Corevalve versions): The support frame is manufactured from nitinol, which has multilevel, self-expanding properties and is radiopaque. The bioprosthesis is manufactured by suturing valve leaflets and a skirt from porcine pericardium into a tri-leaflet configuration (manufactured by Medtronic CoreValve LLC, Santa Ana, USA).
15959391|NCT03192774|Device|Transcatheter Aortic Valve Implantation|Interventional replacement of the aortic valve
15959392|NCT03192761|Procedure|ACL reconstruction hamstrings|"HG reconstruction is performed according to the standard procedure of the department:
~A double semi-Tendinosus and gracillis graft is used. Placement of the bony tunnels is anatomical, and the femoral tunnel is positioned through the antero-medial portal. Fixation proximally is by CL-endobutton and at the tibia by Intrafix sheet and screw"
15959393|NCT03192761|Procedure|ACL reconstruction patella tendon|"PTBG reconstruction is performed according to the standard procedure of the department:
~A bone patella tendon bone graft of 1 cm width from the midportion of the tendon is used. Placement of the bony tunnels is anatomical, the femoral being positioned through the antero-medial portal. Fixation proximally and distally is by interference screws."
15959394|NCT03192761|Procedure|ACL reconstruction iliotibial tract|"TIFLG reconstruction is performed as follows:
~The TIFL graft is harvested using two lateral incisions. The graft is left attached to the distal iliotibial tract. Placement of the bony tunnels is anatomical, the femoral being drilled outside-in. The tibial drill tunnel is made by retrograde drilling 20 mm, leaving cortical bone at the distal end of the tunnel. Fixation distally is by CL-endobutton or interference screw and on femur by an interference screw outside-in."
15959395|NCT03192735|Drug|ApatinibMesylateTablets|Subject will be given ApatinibMesylateTablets 500mg/per day, from day1-day 21,per os; Oxaliplatin for Injection 130mg/m2 /per day，ivgtt，in day1; Gimeracil and Oteracil Porassium Capsules twice times a day,from day1-day 14,per os,and the dosage according body surface area:<1.25m2, 40mg every time;1.25-1.5m2,50mg every time; >1.5m2, 60mg every time.A course of treatment need 21days. Every subject need 2-5 courses accrding to tumor assessment by clinician. The last course stop ApatinibMesylateTablets.
15959396|NCT03192722|Device|Colored near reading glasses|Participants are provided with colored near vision glasses.
15959397|NCT03192722|Device|Lighting as determined by LuxIQ/2 or OttLite Cobra|Participants are provided preferred lighting (either OttLite or lamp with findings from LuxIQ/2)
15959398|NCT03192709|Drug|Sildenafil vaginal suppositories|Sildenafil vaginal suppositories (100 mg/day) from the start of HMG administration day until the day of oocyte retrieval.
15959399|NCT03192709|Other|vaginal placebo|Daily vaginal placebo from the start of HMG administration day until 2 days before the hCG injection day, then will be switched to vaginal sildenafil suppositories (100 mg/day) until the day of oocyte retrieval.
15959400|NCT03192709|Other|vaginal placebo|Daily vaginal placebo from the start of HMG administration day until the day of oocyte retrieval.
15959401|NCT03192696|Device|Atherectomy Catheter|Treatment of restenotic lesions within stents previously placed within the artery.
15959402|NCT03192683|Device|Providence Pedi Cast-Sling|Custom made sling with readily available casting materials
15959403|NCT03192683|Device|Regular sling|
15959404|NCT03192670|Device|Low-level light therapy device|Peak wavelength:610nm, Power intensity: 1.7mW/cm2, Energy density: 2.0J/cm2, Skin-adhesive light-emitting probes: spot size, 1cm diameter
15959405|NCT03192657|Drug|Basiliximab|The first administration should be within 8 weeks after disease onset.
15959406|NCT03192657|Drug|Calcineurin Inhibitors|Researchers can choose cyclosporin A or tacrolimus according to patient tolerance. Either agent should be applied promptly once infection is ruled out for a patient.
15959407|NCT03192657|Drug|Steroids|Dosage of steroid can be adjusted according to personal experience of the researcher.
15959408|NCT03192644|Procedure|TAI|transarterial chemoinfusion with mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)
15959409|NCT03192644|Procedure|TACE|transarterial chemoembolization with epidoxorubicin and cisplatin and lipiodol
15959410|NCT03192644|Drug|epidoxorubicin and cisplatin and lipiodol|epidoxorubicin and cisplatin and lipiodol
15959411|NCT03192644|Drug|mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)|oxaliplatin, calcium folinate, and 5-FU
15959412|NCT03192631|Other|Financial incentive|Incentive of $15 Canadian
15959614|NCT03191123|Procedure|TACE|The aim of this intervention is one of the palliative treatment.
15959414|NCT03192618|Drug|mFOLFOX6 (oxaliplatin, calcium folinate, and 5-FU)|oxaliplatin, calcium folinate, and 5-FU
15959415|NCT03192605|Other|Blueberry|Blueberry - 150 grams wild blueberries (whole fruit)
15959416|NCT03192605|Other|Placebo|Placebo - matched for calories and fiber
15959417|NCT03192592|Other|Body moisturizer|Daily body moisturizer application for skin protection and barrier.
15959418|NCT03192579|Drug|EPA and high dose rosuvastatin|After randomization, patients with intensive lipid lowering therapy start EPA (1800mg/day) and high dose rosuvastatin (10mg/day) for 12 months.
15959419|NCT03192579|Drug|Standard dose rosuvastatin|After randomization, patients with standard lipid lowering therapy start only rosuvastatin (2.5mg/day) for 12 months.
15959420|NCT03192566|Drug|Tylenol|Dosing of Tylenol for post operative pain control
15959421|NCT03192553|Behavioral|Double Gloving Procedure|Participants will doff PPE using a double gloving procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis
15959422|NCT03192553|Behavioral|Intensified Hand Hygiene Procedure|Participants will doff PPE using an intensified hand hygiene procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis
15959423|NCT03192553|Behavioral|One Step Procedure|Participants will doff PPE using a one-step procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis
15959424|NCT03192553|Behavioral|CDC Procedure|Participants will doff PPE using a CDC recommended procedure after coating with Glogerm fluorescent dye +/- staphylococcus epidermidis
15959425|NCT03192540|Other|Exercise|Participants will undergo an exercise protocol once a week, for eight weeks. Exercise will be continuous for one hour.
15959426|NCT03192527|Drug|KN015|experimental drug
15959427|NCT03192527|Drug|Placebo|Comparator.
15959428|NCT03192527|Drug|Triptorelin|The drug is used for down-regulation of endogenous FSH.
15959429|NCT03192514|Other|Electronic Deprescribing tool|"Each GP of the intervention group will have exclusive access to an electronic tool that will guide them on deprescribing. The innovative electronic tool created by the researchers provide the rationale on indications for prescribing or deprescribing Benzodiazepines or/and Non-benzodiazepine hypnotics and also provides an interactive tapering suggestion integrated on a calendar.
~The tool emphasizes that any decision to continue or discontinue a drug remains a shared decision between GP and the patient.
~The electronic Deprescribing tool is designed to support clinical decisions"
15959430|NCT03192488|Drug|Cetirizine|Cetirizine tablet 10 mg
15959431|NCT03192488|Drug|Placebo oral capsule|Gelatin placebo
15959432|NCT03192488|Other|Hypoxia|Exposure to a 14.3% oxygen environment simulating an altitude of 3,000m/9,000ft
15959433|NCT03192475|Behavioral|GLB plus phone contacts|GLB is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The active treatment group also receives 8 additional group phone conference calls for social support and problem solving.
15959434|NCT03192475|Behavioral|GLB plus newsletter contacts|GLB is a comprehensive evidence-based lifestyle intervention derived from the Diabetes Prevention Program intensive lifestyle intervention; combines behavior modification strategies and making health changes to diet, physical activity and weight. The placebo comparator includes 4 additional newsletters only.
15959435|NCT03192462|Biological|multiTAA specific T cells|Each patient will receive 6 infusions of multiTAA T cells at a fixed cell dose (1 x 10^7 cells/m2) at the times specified in the group description. The expected volume of infusion will be 1 to 10 cc.
15959436|NCT03192449|Drug|Albendazole.|Single dose 400mg orally
15959437|NCT03192436|Device|Ultrasound|Low-intensity (Ispta < 720 mW/cm2, Isppa < 190 W/cm2) transcranial focused ultrasound
15959438|NCT03192410|Behavioral|Dietary intake|Intake of nutrients, foods, food groups, beverages; dietary patterns.
15959439|NCT03192410|Behavioral|Lifestyle factors|Physical activity; smoking; alcohol use; educational level.
15959440|NCT03192410|Biological|Blood biomarkers|Biomarkers of dietary intake (e.g. fatty acids); biomarkers of disease.
15959441|NCT03192410|Biological|Health|Current health status; medical history; medication use; self-rated health; risk factors for disease (e.g. body mass index, blood pressure, blood lipids, glucose)
15959442|NCT03192410|Genetic|DNA|SNPs (GWAS)
15959443|NCT03192410|Biological|Mental well-being|Cognitive function; dispositional optimism; depression.
15959444|NCT03192397|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic hematopoietic stem cell transplant
15959445|NCT03192397|Drug|Cyclophosphamide|Given IV
15959446|NCT03192397|Drug|Fludarabine Phosphate|Given IV
15959447|NCT03192397|Other|Laboratory Biomarker Analysis|Correlative studies
15959448|NCT03192397|Drug|Melphalan Hydrochloride|Given IV
15959449|NCT03192397|Drug|Mycophenolate Mofetil|Given IV
15959450|NCT03192397|Drug|Sirolimus|Given IV and PO
15959451|NCT03192397|Radiation|Total-Body Irradiation|Undergo TBI
15959452|NCT03192384|Behavioral|Educational programme|Educational programme for ward staff
15959453|NCT03192371|Biological|Rabipur|Rabies vaccine administered as an intramuscular injection according to Zagreb or Essen regimen to subjects aged ≥6 to ≤17 years.
15959454|NCT03192358|Diagnostic Test|Videofluoroscopic Swallowing Examination|During the videofluoroscopy, subjects will take up to 21 sips of liquid, ranging in thickness from thin (like water), to extremely-thick (like pudding or custard). The liquids will be mixed with E-Z-Paque barium sulfate, to allow it to be visible on the x-ray.
15959455|NCT03192358|Other|Tongue Strength Measurement|"We will measure tongue strength using a tongue pressure measurement system called the Iowa Oral Performance Instrument (IOPI). A small disposable bulb filled with air will be placed in the mouth, just behind the front teeth. Participants will be asked to press their tongue upwards against the bulb as hard as they can, three (3) times at the front of the tongue and three (3) times at the back of the tongue (i.e., total of six (6) maximum isometric tongue presses). Participants will also be asked to swallow their saliva with the bulb placed in their mouth, three (3) times.
~Tongue pressure measurement will be completed twice in the data collection session - once at the beginning, and once at the end (following the videofluoroscopy)."
15959456|NCT03192345|Biological|SAR439459|"Pharmaceutical form: powder for solution for infusion
~Route of administration: intravenous infusion"
15959615|NCT03191110|Other|No intervention: observational study|
15959457|NCT03192345|Drug|Cemiplimab REGN2810|"Pharmaceutical form: solution for infusion
~Route of administration: intravenous infusion"
15959458|NCT03192332|Device|Stent-retriever thrombectomy with revascularization device of the Solitaire™ type|Mechanical thrombectomy with a stent-retriever revascularization device
15959459|NCT03192332|Drug|Intravenous thrombolysis with recombinant tissue-type plasminogen activator (IV t-PA)|Bridging thrombolysis (IV t-PA plus mechanical thrombectomy) according to current European and North American stroke guidelines.
15959460|NCT03192319|Biological|Zostavax|Zostavax will be administrated by subcutaneous injection
15959461|NCT03192306|Drug|Merlin|glycolic acid/ethanol solution
15959462|NCT03192306|Drug|Ethanol|Ethanol solution
15959463|NCT03192293|Drug|Metformin/Simvastatin/Fulvestrant|"7 days Lead-in period: Metformin: 850mg (one tablet) twice a day Simvastatin: 20mg (one tablet) once every night
~Once the doctor has deemed that patients have tolerated Simvastatin and Metformin well, patients will receive Fulvestrant at standard doses:
~Cycle 1: 500mg (in the form of two injections, 1 in each buttock) at Day 1 and Day 15. Each cycle comprises of 28 consecutive days starting from Day 1.
~Cycle 2 and beyond: 500mg at Day 1 of each 28-day cycle.
~Tumour biopsy at 8 weeks. Every 8 weeks for the first 6 months, every 12 weeks thereafter:
~Performance status evaluation Medical history and physical examination Clinical tumor measurement Review of treatment-related side-effects Blood taking for research purpose and routine blood tests Routine scans"
15959464|NCT03192280|Drug|Leukotriene B4|Leukotriene B4 (LTB4)
15959465|NCT03192280|Device|FLIR One|Thermal imaging attachment to iPhone
15959466|NCT03192280|Device|SCIO|Handheld near-IR molecular spectroscopy device
15959467|NCT03192280|Device|MS Band 2|"Wearable watch-like device with multiple sensors"
15959468|NCT03192280|Device|AGE reader|Portable bench top device for in-clinic near UV assessment
15959469|NCT03192280|Device|HSI prototype (PARC) hyper-spectral camera|Portable bench top device for in-clinic multispectral imaging
15959470|NCT03192280|Device|iPhone 7|Smart phone
15959471|NCT03192254|Behavioral|self-monitoring|recording fruit and vegetable consumption
15959472|NCT03192254|Behavioral|daily monetary incentives|daily payments for consuming fruits and vegetables
15959473|NCT03192254|Behavioral|delayed lump sum monetary incentives|lump sum payments for consuming fruits and vegetables
15959474|NCT03192241|Other|Pump|Intervention is providing mothers with a manual breast pump and instructions for when it could be used.
15959475|NCT03192241|Other|Book|Active control intervention is providing mother's with a children's book and information about reading to baby.
15959476|NCT03192228|Other|Treatment adequacy score|Evaluation of the program rate of success rate by a score evaluating the different criteria that the patient was supposed to modify following the therapeutic education program: practice of a physical activity, reduction of the amount of fat in Diet, practice of self-monitoring blood sugar as a motivational tool and decreased distress related to diabetes
15959477|NCT03192215|Drug|Apixaban|5 mg by mouth twice daily (2.5 mg for subjects meeting standard criteria for an adjusted dose).
15959478|NCT03192215|Drug|Aspirin|Aspirin 81 mg by mouth once daily.
15959479|NCT03192202|Drug|AFM13|AFM13 is a recombinant antibody construct against human CD30 and CD16A. It will be given to patients intravenously at the dose and schedule applicable to the cohort the patient was enrolled in specified in the various arms listed.
15959480|NCT03192189|Other|monitoring for progression to chronic kidney disease|Collect clinical information and assess risk factors
15959481|NCT03192176|Drug|Fezolinetant|Oral Capsule
15959482|NCT03192176|Drug|Placebo|Oral Capsule
15959483|NCT03192163|Other|Survey|31 question survey with questions regarding non-identifying demographic information such as age and gender. This survey also contains questions about acne treatment preferences, racial/ethnic background, and cultural identity in addition to a few Willingness to Pay questions.
15959484|NCT03192150|Drug|ISV-305|Dexamethasone in DuraSite® 2 twice daily for 16 days
15959485|NCT03192150|Other|Vehicle|Vehicle twice daily for 16 days
15959486|NCT03192137|Drug|ISV-305|Dexamethasone in DuraSite® 2 twice daily for 16 days
15959487|NCT03192137|Other|Vehicle|Vehicle twice daily for 16 days
15959488|NCT03192124|Device|Bactisure|"Level 1 Panel is a quantitative real-time PCR test to detect 12 microbial organisms that may be present in patient specimen (bacteria and fungi) and includes test for resistance factors to vancomycin and methicillin.
~Microbial DNA in each sample will be sequenced using the Ion Torrent PGM sequencer in order to establish what type of bacterial and fungal species are present."
15959489|NCT03192111|Drug|Entinostat|HDAC (histone deacetylase) inhibitor
15959490|NCT03192098|Device|Savary bougie dilation|Patients will be dilated with the use of the Savary bougienage device
15959491|NCT03192085|Diagnostic Test|SITA FAST VISUAL FIELD TEST|Diagnostic test for glaucoma
15959492|NCT03192085|Diagnostic Test|SITA STANDARD VISUAL FIELD TEST|Diagnostic test for glaucoma
15959493|NCT03192072|Diagnostic Test|Host Gene Expression|comparison to retrospective clinical adjudication
15959494|NCT03192059|Drug|Pembrolizumab|Efficacy of the combined treatment
15959495|NCT03192059|Radiation|Radiation|Efficacy of the combined treatment
15959496|NCT03192059|Drug|Vitamin D|Efficacy of the combined treatment
15959497|NCT03192059|Drug|Aspirin|Efficacy of the combined treatment
15959498|NCT03192059|Drug|Lansoprazole|Efficacy of the combined treatment
15959499|NCT03192059|Drug|Cyclophosphamide|Efficacy of the combined treatment
15959500|NCT03192059|Dietary Supplement|Curcumin|Efficacy of the combined treatment
15959501|NCT03192046|Device|Carbon Fiber Ankle Foot Orthosis (AFO)|Custom AFOs in conjunction with a walking program, working up to walking 30 minutes 6 days a week.
15959502|NCT03192033|Other|Arterial closure to ensure hemostasis at femoral artery puncture points|Arterial closure devices used: Proglide® (Abbott)
15959503|NCT03192033|Device|Proglide® (Abbott)|Arterial closure device used: Proglide® (Abbott)
15959504|NCT03192033|Device|Femoseal® (Terumo)|Arterial closure device used: Femoseal® (Terumo)
15959505|NCT03192033|Other|Arterial closure to ensure hemostasis at femoral artery puncture points|Arterial closure device used: Femoseal® (Terumo)
15959616|NCT03191097|Drug|Ingavirin|Ingavirin capsules 60 mg once daily, regardless of meal, for 5 days.
15959617|NCT03191097|Drug|Placebo oral capsule|Placebo, capsules daily for 5 days.
15959506|NCT03192020|Procedure|Percutaneous needle fasciotomy|PNF is a treatment in which the cord causing the contracture is not excised, but only divided with a hypodermic needle. The division of the cord can be made under local anesthesia in the clinic and takes only a few minutes to perform. It can be performed whenever the cord is palpable. There are only puncture wounds left, and hence, the patient can start normal use of the hand the day after the procedure.
15959507|NCT03192020|Drug|Collagenase Clostridium Histolyticum 2.9 MG/ML [Xiaflex]|CCH chemically dissolves type I collagen of which the cord is composed of. It is injected inside the cord in the outpatient clinic and the cord can be ruptured by gently force after a day or two.
15959508|NCT03192020|Procedure|Limited fasciectomy|In LF, the thickened part of the palmar fascia causing the contracture is excised through skin incision. LF is performed in general or regional anesthesia in operating room. LF has been the dominant technique of surgical treatment.
15959509|NCT03192007|Device|Magnetic Resonance Imaging|Investigate anatomic and functional characteristics of transplant kidneys using MRI
15959510|NCT03191994|Behavioral|Exercise|a structured, supervised eight week moderate intensity exercise intervention
15959511|NCT03191981|Drug|Cyclophosphamide|Treatment for all patients will be with cyclophosphamide, lenalidomide and pembrolizumab at fixed doses.
15959512|NCT03191981|Drug|Lenalidomide|Treatment for all patients will be with cyclophosphamide, lenalidomide and pembrolizumab at fixed doses.
15959513|NCT03191981|Drug|Pembrolizumab|Treatment for all patients will be with cyclophosphamide, lenalidomide and pembrolizumab at fixed doses.
15959514|NCT03191968|Behavioral|Supervised Physical Activity Plus Behavioral Counseling|In addition to supervised physical activity, behavioral counseling sessions will be delivered with a PA specialist based on the Multi-process Action Control (M-PAC) framework and include behavior change techniques addressing information regarding the consequences, social support, goal setting, self-monitoring, cues and prompts, barrier identification, intention formation, planning, and habit and identity formation
15959515|NCT03191968|Behavioral|Supervised Physical Activity Plus Exercise Counseling|In addition to the supervised exercise sessions, standard exercise counseling will be delivered by a PA specialist to teach proper PA and resistance training techniques, how to monitor intensity, and to progress PA safely and effectively to achieve the public health PA guideline.
15959516|NCT03191942|Device|Modified ortho-k lenses|KETT MC lens
15959517|NCT03191942|Device|Ortho-k lenses|KATT BeFree lens
15959518|NCT03191929|Other|HIT Intervention|"Patients in the HIT intervention completed a multi-media, culturally adapted, mental health risk assessment tool in their preferred language prior to their baseline health care visit with their primary care provider. Patients' scores were transmitted to the provider prior to their clinic visit.
~Providers in the HIT intervention received a web-based training developed by the Harvard Program in Refugee Trauma to train providers in delivering culturally competent, trauma-informed care to address mental health problems and other trauma-related medical issues in patients who experienced extreme war trauma. Providers also received ongoing clinical decision support through a mobile application to support the diagnosis and initiation of treatment for depression and/or PTSD."
15959519|NCT03191929|Other|Minimal Intervention Control Arm|"Patients in the Minimal Intervention Control Arm completed a multi-media, culturally adapted, mental health risk assessment tool in their preferred language prior to their baseline health care visit with their primary care provider; however, patients' scores in the Minimal Intervention Control Arm were only transmitted to the provider prior to their clinic visit if they showed evidence of being at risk to harm either themselves or others.
~Providers in the Minimal Intervention Control Arm completed the online tutorial, A physician's practical guide to culturally competent care, which was provided by The Office of Minority Health, US Department of Health and Human Services Website."
15959520|NCT03191916|Device|transcranial direct current stimulation|2milliamps will be administered for 5 consecutive days for a duration of 20 minutes with electrode placement at the left dorsolateral prefrontal cortex.
15959521|NCT03191916|Device|Sham (for transcranial direct current stimulation)|For 30 seconds the patient will experience a ramp up of the stimulation, after which point no stimulation will be transmitted for the remainder of the session. This will be administered for 5 consecutive days for a duration of 20 minutes with electrode placement at the left dorsolateral prefrontal cortex.
15959522|NCT03191903|Drug|Cingal|A chemically cross-linked sodium hyaluronate supplied as a 4-mL unit dose with a nominal 18 mg of triamcinolone hexacetonide (TH)
15959523|NCT03191903|Device|Monovisc|A chemically cross-linked sodium hyaluronate supplied as a 4-mL unit dose
15959524|NCT03191903|Drug|Triamcinolone Hexacetonide|20 mg/ml supplied as 1 mL unit dose of Triamcinolone Hexacetonide
15959525|NCT03191877|Dietary Supplement|coffee|"Nescafe brand of coffee made by Nestlé, red mug 100 % pure coffee 12083811"
15959526|NCT03191864|Drug|APT-1011|APT-1011 is an orally disintegrating tablet formulation of fluticasone propionate
15959527|NCT03191864|Drug|Placebo|Placebo tablets are identical in composition to APT-1011 except they exclude the active ingredient.
15959528|NCT03191851|Device|standard device|paracentesis using standard
15959529|NCT03191851|Device|Melody Device|paracentesis using Melody Device
15959530|NCT03191851|Device|Melody Device with Pump|paracentesis using Melody Device with Pump
15959531|NCT03191838|Other|Audiovisual Distraction|The interventional group will be given audiovisual equipment. An Apple iPad will be attached to a Mayo stand and placed approximately 12-15 inches from the patient's face. Noise canceling headphones will be connected to the iPad. A movie of the subject's choosing will be shown on the iPad with a comfortable level of sound.
15959532|NCT03191825|Other|Endre: a digital smoking cessation counsellor|A comprehensive 25-session intervention delivered by web, e-mail and SMS-text messages. Sessions are released one each day for 18 days, and then every second day for 14 days. Intervention content is tailored based on user input and individual usage pattern. The intervention is described in detail in Holter, Johansen & Brendryen (2016). How a fully automated eHealth program simulates three therapeutic processes: A case study. Journal of Medical Internet Research 18 (6).
15959533|NCT03191825|Other|Lapse management system triggered from web-page|"The lapse management system is based on a day-to-day logging of the target behavior (smoking). This logging goes on for four weeks after an initial quit attempt. The current version of the system logs by asking the participant about their smoking status every time they log on to Endre (the digital smoking cessation counsellor). Participants that report a lapse is routed to a fully automated counselling session delivered by web."
15959534|NCT03191825|Other|Lapse management system triggered by SMS-textmessage|The lapse management system is based on a day-to-day logging of the target behavior (smoking). This logging goes on for four weeks after an initial quit attempt. The current version of the system logs by asking the participant about their smoking status in a textmessage (SMS) sent each evening. Participants that report a lapse, receives a new SMS with a link to a fully automated counselling session delivered by web.
15959535|NCT03191812|Other|transcranial Direct Current Stimulation (tDCS)|There will be three different tDCS targets as well as a sham stimulation condition. The stimulation for each of these conditions will be delivered via 6 already-placed gel electrodes on the participant's scalp with different combinations of current intensities among all the electrodes.
15959536|NCT03191799|Drug|Emicizumab|Initial dosing will be 3 mg/kg/week subcutaneously for 4 weeks; Maintenance dosing will follow at 1.5 mg/kg/week subcutaneously for the remainder of the 2-year treatment period
15959537|NCT03191786|Drug|Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody|Atezolizumab will be administered via IV infusion once every three weeks (QW3).
15959538|NCT03191786|Drug|Vinorelbine|Vinorelbine will be administered per relevant local guidelines and Summary of Product Characteristics (SmPC) management.
15959539|NCT03191786|Drug|Gemcitabine|Gemcitabine will be administered per relevant local guidelines and SmPC management.
15959540|NCT03191773|Combination Product|Drugs and anti-CD19 CAR transduced T cells|"Drug: Fludarabine On days -4 through -2, Fludarabine 30mg/m2 (IV) will be infused over 30 minutes.
~Drug: Cyclophosphamide On days -4 through -2, Cyclophosphamide 300-500mg/m2 IV will be infused over 60 minutes followed by fludarabine.
~Biological: Anti-CD19-CAR T cells On day 0, cells will be infused intravenously IV over 20 - 30 minutes."
15959541|NCT03191760|Behavioral|Behavioral Activation|Participants will be asked to attend 6 in-person therapy sessions lasting approximately 45 minutes per session, to be held in Primary Care settings. Content of therapy sessions includes education about PTSD symptoms, discussion of the role of avoidance in maintaining PTSD symptoms, self-monitoring homework to identify links between activity level and emotions, and homework designed to increase engagement in valued activities, with a focus on increasing social contact and support. If relevant, participants will be instructed in basic communication skills, social skills, and relaxation skills.
15959542|NCT03191734|Device|AQUABEAM System|Aquablation is a minimally invasive transurethral surgical procedure using the AQUABEAM system, a personalized image-guided waterject resection system that utilizes a high-pressure saline stream to resect and remove prostate tissue.
15959543|NCT03191721|Procedure|Surgical anti-infective therapy|Two months before randomization, implants with peri-implantitis received surgical anti-infective therapy. After local anesthesia (2% lidocaine with 1:100,000 epinephrine), intrasulcular incisions were done and buccal and lingual full-thickness flaps were dissected. Granulation tissue was removed to expose the implant threads and bone defect. To remove biofilm and calculus, the implant surface was scaled with teflon curettes and decontaminated with bicarbonate jet (Jet Sonic System). The flap was repositioned in the original position and stabilized with interrupted sutures, which were removed after 10 days
15959544|NCT03191721|Procedure|Periodontal treatment|Two months before randomization, all subjects received full-mouth supragingival plaque removal and scaling and root planing (SRP), as needed. The SRP was performed in four to six appointments lasting approximately 1 h each, using manual curettes (Hu-Friedy, Chicago, IL, USA) and ultrasonic device (Cavitron Select SPC, Dentsply professional, York, PA, USA) under local anesthesia. The deep sites were scaled throughout the first week and treatment of the entire oral cavity was completed in 14 days.
15959545|NCT03191721|Procedure|Oral Hygiene Instruction|Delivery of a soft bristle adult toothbrush (Colgate Palmolive, Brazil), dental floss (Colgate Palmolive, Brazil), and interdental toothbrushes (Colgate Palmolive, Brazil) , according to their individual needs at pre-baseline, baseline, 3, 6, 12, 18 and 24 months. Information was given about the importance of keeping an excellent oral hygiene over the course of the study. The subjects were instructed to brush their teeth for one minute twice a day (morning and evening) using only the toothbrush and toothpaste provided.
15959546|NCT03191721|Drug|Triclosan toothpaste|Dental brushing with a toothpaste containing 0.3% triclosan and 1450 ppm sodium fluoride in a regular maintenance program for 24 months.
15959547|NCT03191721|Drug|Fluoride toothpaste|Dental brushing with a toothpaste containing 1450 ppm sodium monofluorphosphate in a regular maintenance program for 24 months.
15959548|NCT03191721|Procedure|Regular maintenance program|OHI, supragingival and subgingival biofilm removal from teeth and implants, and oral prophylaxis. If the examiner suspected of peri-implant disease progression, periapical radiographs were taken. If the implant showed ≥ 2 mm of bone loss, it was withdrawn from the study to receive additional treatment (e.g. another surgery procedure). Implants showing severe disease progression associated with mobility were removed. Maintenance visits were performed every 3 months.
15959549|NCT03191708|Diagnostic Test|Fractional Flow Reserve (FFR)|FFR measured by pressure wire, QFR computed by coronary angiographic images
15959550|NCT03191695|Other|Assessment via questionnaire|All the children will be assessed via assessment questionnaires.
15959551|NCT03191682|Drug|PRL3-ZUMAB|The starting dose will be 0.3 mg/kg, administered Q2 weekly, with the subsequent dose levels being 0.9 mg/kg, 3.0 mg/kg, and 6.0 mg/kg, all administered on a Q2 weekly basis until disease progression. The investigator will monitor each subject for the occurrence of AEs. In event of infusion-related adverse events, the Investigator, in consultation with the PI, may increase the duration of the infusion over a period of up to 24 hours at their discretion. Dosing will continue in a standard 3+3 design for dose escalation.
15959552|NCT03191669|Other|Auto-questionnaire|Single Auto-questionnaire administered during or after a consultation/hospitalization
15959553|NCT03191656|Device|IASD Implant|Implantation of the IASD device using trans-septal puncture and the IASD system
15959554|NCT03191630|Behavioral|Fitbit (Control)|Study procedures include group sessions at the OSU Transplant Clinic with 10-12 participants for 6 months and a 6-month maintenance phase without contact from study personnel until month 12. Session 1 for the control group will be identical to the Intervention with the only exception being that participants in the control group will not be asked to increase their step goal. Throughout their participation, subjects will be asked questions only about their use of the Fitbit activity tracker. The research team will not be in contact with them for 6 months, after which time there will be a final group session.
15959618|NCT03191084|Drug|Low Dose THC Marijuana|Dosing via vaporized marijuana using a lower concentration of THC, participants receive this dose on two of the five study visits.
15959555|NCT03191630|Behavioral|SystemCHANGE and Fitbit (Intervention)|Study procedures include group sessions with 10-12 participants for 6 months and a 6-month maintenance phase without contact from study personnel until month 12. Study personnel will demonstrate proper Fitbit activity tracker use, and teach participants to sync to their smartphone and retrieve data from their Fitbit. Subjects will be called to encourage them to increase their step goal 5% each month. Fitbit activity tracker reports will be reviewed and participants will be asked to identify what people or things influence their physical activity. Subjects will be asked what they are learning about physical activity, their contentment level with current physical activity, and if they want to make changes. Participants will continue for months, after which time there will be a final group session.
15959556|NCT03191617|Dietary Supplement|Human milk fortifier|Fortification of breastmilk with liquid human milk fortifier in premature infants
15959557|NCT03191604|Other|Video intervention|Video clips of endoscopy footage with just HD-WLE and clips with NBI will be shown to endoscopists.
15959558|NCT03191591|Behavioral|First 1,000 Days Program Site|Program components will include 1) Enhancements to and improved use of electronic health records to improve the quality of preventive services and screening for social determinants of health; 2) Staff and provider training; 3) Consistent behavior change messaging; 4) Patient education via print materials, text messaging and short videos; and 5) Strengthening the integration of clinical and public health services to support behavior change and address social determinants of health.
15959559|NCT03191578|Drug|RUTI®|Administration of RUTI®
15959560|NCT03191578|Drug|Placebo|Administration of placebo
15959561|NCT03191565|Other|Paper diary sheet|Writing skill-use and symptoms on a week matrix type sheet
15959562|NCT03191565|Device|Monsenso DBT-app and IT monitoring program|Entering skill-use and symptoms on a smartphone with Monsenso DBT-app and IT monitoring program
15959563|NCT03191552|Device|SPIO|"SPIO (stabilizing input pressure orthosis) 2 hours will receive conventional exercise therapy with the garment on during 2 hours. SPIO 6 hours group wore the SPIO 4 hours more in addition to 2 hours during therapy.
~SPIO 6 hours group will wear the SPIO 4 hours more in addition to 2 hours during therapy.
~(conventional exercises :range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills"
15959564|NCT03191552|Other|conventional exercises|range of motion, strengthening, trunk control and strengthening exercises and exercises to improve fine and gross motor skills
15959565|NCT03191539|Drug|Apremilast|30 mg twice a day during 52 weeks. In the first 6 days will be a dose escalation
15959566|NCT03191526|Drug|KW-0761 0.3 mg/kg IV|Intravenous injection every 12 weeks.
15959567|NCT03191526|Drug|Placebo (saline)|Intravenous injection every 12 weeks.
15959568|NCT03191513|Dietary Supplement|Interesterified blend of palm kernal and plam stearin|50 g fat provided as interesterified palm kernal and palm sterin blend in a single meal (sub-group, n=12, also have 75 mg 13C labelled tripalmatin and 1.2 g / kg body water deuterated water)
15959569|NCT03191513|Dietary Supplement|Un-interesterified blend of palm kernal and plam stearin|50 g fat provided as un-interesterified palm kernal and palm sterin blend in a single meal (sub-group, n=12, also have 75 mg 13C labelled tripalmatin and 1.2 g / kg body water deuterated water)
15959570|NCT03191513|Dietary Supplement|Rapeseed oil|50 g fat provided as rapeseed oil in a single meal (sub-group, n=12, also have 75 mg 13C labelled tripalmatin and 1.2 g / kg body water deuterated water)
15959571|NCT03191500|Device|steerable catheter|peripheral vascular disease
15959572|NCT03191487|Other|ChimioPal|"Systematic collection of clinical and laboratory toxicities (TXs) during the 2-4 days preceding a chemotherapy (CT) session (48H before a session (D-2 towards the end of the afternoon) and a maximum of 96h before sessions occurring on Mondays (D-4 towards the end of the afternoon). Clinical TX data will be collected via ChimioPal (a self-questionnaire administered by smartphone) and laboratory TX data will be collected via Apicrpyt (secure messaging service) or a fax-to-email service. Data flow management by a nurse dedicated to this activity in each centre will be implemented. If the results of the assessment do not authorize CT, additional assessments may be prescribed. If the experimental data transmission does not occur, the usual pathways will be implemented.
~Patient training on how to use a smart phone and the questionnaire will be performed by a nurse before the start of the first chemotherapy session, with reminders at the following sessions if required."
15959573|NCT03191487|Other|Usual pathways|In the standard arm, the usual management and logistic pathways will be respected. Only extra data collection is required by this study.
15959574|NCT03191474|Behavioral|T-POWr Intervention|"All participants will be asked to complete a secure confidential online survey focusing on needs assessment.
~Participants in the T-POWr Intervention Arm will receive a client-centered case management consultation based on how the participant responds to the online survey. The T-POWr will refer participants to assistance services based on the needs assessment, including accessing general health care, health insurance, hormone replacement therapy, housing, mental health care, domestic violence care, substance use treatment, etc. Each resource is extensively vetted to assure a trans-friendly experience and will be tailored to each geographic area across the project enrollment sites. The study facilitates referrals for services but will not provide extensive and ongoing case management."
15959575|NCT03191461|Diagnostic Test|Adenosine stress test MRI|Participants will receive a contrasted adenosine stress CMR examination on a 1.5T Siemens Avanto scanner (Siemens Medical Solutions, Malvern, PA) dedicated to cardiovascular imaging. Adenosine stress was selected due to attenuated endothelium dependent and -independent vasodilation after doxorubicin receipt in humans to allow the investigators to understand the potential effect of perivascular fibrosis on perfusion reserve. Standardized CMR protocols will be performed to measure LV volumes (to assess wall motion abnormalities and identify any potential myocardial dysfunction), Native T1, ECV, and myocardial perfusion reserve in the short-axis plane
15959576|NCT03191448|Procedure|Ridge preservation|Ridge preservation consists of grafting an extraction socket with a bone substitute and /or cover it with a membrane or a dressing. This intervention is aiming at limiting the osseous dimensional changes that would have taken place if the extraction would have been left to heal spontaneously.
15959577|NCT03191448|Device|FDBA|Ridge preservation consists of grafting an extraction socket with a bone substitute and /or cover it with a membrane or a dressing. This intervention is aiming at limiting the osseous dimensional changes that would have taken place if the extraction would have been left to heal spontaneously. In this study a freezed dried bone allograft (FDBA) will be used and the site will be covered with a collagen wound dressing (Collaplug)
15959578|NCT03191448|Device|Collagen wound dressing|Ridge preservation consists of grafting an extraction socket with a bone substitute and /or cover it with a membrane or a dressing. This intervention is aiming at limiting the osseous dimensional changes that would have taken place if the extraction would have been left to heal spontaneously. In this study a freezed dried bone allograft (FDBA) will be used and the site will be covered with a collagen wound dressing (Collaplug)
15959579|NCT03191435|Device|Inspiratory muscle training.|Patients will perform the inspiratory muscle training using a moderate load of 30% of maximal inspiratory pressure (MIP 30%). The training will be conducted at home in a period of 30 minutes, 7 times a week, during 12 weeks. During inspiratory muscle training, individuals will attend Hospital de Clinicas de Porto Alegre once a week to the supervision of the way the exercise is being performed. Furthermore, load in the device (powerbreathe) will be adjusted for the individual to use next week.
15959580|NCT03191435|Device|Placebo inspiratory muscle|Patients will perform the inspiratory muscle training using a very low load of 2% of maximal inspiratory pressure (MIP 2%). The training will be conducted at home in a period of 30 minutes, 7 times a week, in the course of 12 weeks. During inspiratory muscle training, individuals will attend Hospital de Clinicas de Porto Alegre once a week to the supervision of the way the exercise is being performed.
15959581|NCT03191422|Behavioral|LSVT BIG|LSVT BIG is a motor learning based intervention 4 hour long sessions per week for 4 weeks following a specific protocol. Each session is composed of exercises and participant specific activities, as well as a homework program.
15959582|NCT03191396|Drug|Semaglutide|Dose gradually increased to 1.0 mg, given s.c. (under the skin), once-weekly for 30 weeks. Participants will remain on their pre-study anti-diabetic drugs (tablets), if any
15959583|NCT03191396|Drug|Liraglutide|Dose gradually increased to 1.2 mg, given s.c. once-daily for 30 weeks. Participants will remain on their pre-study anti-diabetic drugs, if any
15959584|NCT03191383|Biological|RSV vaccine (GSK3003891A) formulation 1|Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
15959585|NCT03191383|Biological|RSV vaccine (GSK3003891A) formulation 2|Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
15959586|NCT03191383|Biological|RSV vaccine (GSK3003891A) formulation 3|Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
15959587|NCT03191383|Drug|Placebo (Formulation buffer S9b)|Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
15959588|NCT03191370|Other|Simple distraction technique|Asking the patient to count backwards from 30 to1 in even numbers whilst the procedure is being performed.
15959589|NCT03191370|Drug|Local Anesthetics,Topical|Anesthetic spray
15959590|NCT03191357|Other|n/a observational|Observational study
15959591|NCT03191344|Behavioral|with IPSS|all patient in one group use IPSS to record the parathyroid status. the other group operation as ordinary. record the parathyroid status in verbal description
15959592|NCT03191331|Behavioral|Dietary intervention|Written material on healthy diet during pregnancy, dietary counseling at each maternity clinic visit given by public health nurse, group meeting with a dietician x2.
15959593|NCT03191318|Other|ERAS pathway|ERAS pathway after laparoscopic sleeve gastrectomy
15959594|NCT03191318|Other|Standard pathway|Standard pathway after laparoscopic sleeve gastrectomy
15959595|NCT03191305|Drug|Coumadin|Patients in Coumadin Group would be administered Coumadin with overlap of heparin for first two days followed by Coumadin given orally ,dose being adjusted according to INR .The INR range would be between 2-3.it would be given once a day. The total duration Of coumadin would be six months.
15959596|NCT03191305|Drug|Rivoroxaban|The dose protocol would be similar to the one used in Deep Venous Thrombosis. 15 mg PO q12hr for 21 days with food, Then 20 mg PO qDay for 6 months.
15959597|NCT03191279|Procedure|First aid|Open airway (head tilt, chin lift), recovery position, staunch of bleeding, prevention of hypothermia, cooling of burn, CPR
15959598|NCT03191266|Device|Active rTMS|Active rTMS will receive an intermittent rTMS stimulation protocol.
15959599|NCT03191266|Device|Sham rTMS|Sham rTMS will receive all conditions except the actual intermittent theta burst rTMS stimulation.
15959600|NCT03191253|Other|Medically-appropriate meals and groceries|Full nutrition Intervention Components: (1) 7 pre-packaged frozen meals; (2) Groceries or another 7-pack of meals; (3) Nutritional supplement bag to round out the nutrition in terms of nutrients, or dietary reference intakes (DRIs), and number of servings from fruits/vegetables, whole grains, legumes, nuts/seeds and dairy. The nutritional supplemental bag will also contain bulk ingredients to aid in cooking e.g., cooking oil, spices, and herbs as well as bulk items e.g., jar of peanut butter, quart of milk; (4) Individual nutritional counseling (x2 sessions); and (5) Group nutrition education classes (X3 classes) by POH registered dietitian (RD) team.
15959601|NCT03191240|Drug|Vasopressins|Administer additional vasopressin 40 IU IV for 2 times during cardiopulmonary resuscitation
15959602|NCT03191240|Drug|Normal saline|Placebo
15959603|NCT03191214|Device|Intraoperative Forced Air Warming|As part of their standard care, patients undergoing surgery >30 min in duration will receive forced air warming in the form of a Bair Hugger. This is a blanket covering their upper torso and arms into which warm air is blown.
15959604|NCT03191201|Drug|Ferric Carboxymaltose|Ferric Carboxymaltose 1000 mg iron element will be diluted in 250 mL of a commercially available sterile 0.9% sodium chloride solution.
15959605|NCT03191201|Drug|0.9% sodium chloride solution|250 mL of a commercially available sterile 0.9% sodium chloride solution.
15959606|NCT03191188|Drug|Levothyroxine Sodium|Thyroid hormone supplement
15959607|NCT03191188|Drug|Placebo Oral Tablet|Placebo
15959608|NCT03191175|Other|blood sample|47ml blood (40 ml EDTA whole blood for Peripheral blood mononuclear cell (PBMC) and monocytes isolation and 7 ml for serum).
15959609|NCT03191162|Drug|Benznidazole|To evaluate different regimens of Benznidazole for the treatment of chronic Chagas disease
15959611|NCT03191136|Drug|YHD1119 300mg|Period 1:a single dose of YHD1119 300mg is administered in fasting condition Period 2:a single dose of YHD1119 300mg is administered in fed condition
15959612|NCT03191136|Drug|YHD1119 300mg|Period 1:a single dose of YHD1119 300mg is administered in fed condition Period 2:a single dose of YHD1119 300mg is administered in fasting condition
15959613|NCT03191123|Procedure|hepatic resection|The aim of this intervention is to reach curative resection.
15959619|NCT03191084|Drug|High Dose THC Marijuana|Dosing via vaporized marijuana using a higher concentration of THC, participants receive this dose on two of the five study visits.
15959620|NCT03191084|Drug|Placebo Marijuana|Dosing via vaporized marijuana with no THC, participants receive this dose on one of the five study visits.
15959621|NCT03191071|Diagnostic Test|UltraPro|"First, procalcitonin will be measured using a rapid point-of-care test. In case of elevated procalcitonin result (≥0.25 µg/L), a lung ultrasound will be performed to look for the presence of a lung infiltrate or consolidation suggesting the presence of community acquired pneumonia. A portable ultrasound machine with a convex probe, that will be provided to the general practitioner by the study, will be used.
~The lung ultrasound will be done following international evidence-based recommendations for point-of-care lung ultrasound using the basic eight-region sonographic technique and the criteria for positive scan and positive examination for the diagnosis of pneumonia ."
15959622|NCT03191071|Diagnostic Test|Procalcitonin|Procalcitonin will be measured using a rapid point-of-care test
15959623|NCT03191071|Diagnostic Test|Blood sampling|A venous blood sample (17.5 mL) will be collected. Whole blood and plasma will be stored at - 80°C. Further analysis will be performed in order to identify novel biomarkers and gene transcription patterns that could predict the necessity of antibiotic prescription or the severity of disease.
15959624|NCT03191071|Diagnostic Test|Naso-pharyngeal swab and sputum culture|A pooled nasal swab will be performed and sputum will be collected. Samples will be stored at -80°C. Further analysis of the naso-pharyngeal swab and cultures of sputum will be performed to identify by molecular techniques pathogens implicated in the clinical presentation.
15959625|NCT03191058|Device|Magnetic Seizure Therapy|"MST treatment will be administered using the MagPro MST with a Cool TwinCoil over the frontal cortex in the midline position using 100 Hz stimulation. The MST determination of seizure threshold will be done using 100% machine output applied at 100 Hz at progressively escalating train durations, commencing at 2 seconds and increasing by 2 seconds with each subsequent stimulation until an adequate seizure is produced. During subsequent sessions, one stimulation will be delivered using a train duration that is 4 seconds longer than the train duration at threshold (with a maximum train duration of 10 seconds).
~This will be performed under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes."
15959626|NCT03191058|Device|Electroconvulsive Therapy|In the ECT arm treatment, the MECTA spectrum 5000Q machine will be used, which is an FDA approved device used for providing standard-of-care clinical ECT treatments. The ECT determination of seizure threshold and the adjustment of energy at subsequent sessions will be based on a standard published protocol. All participants will receive RUL-UB ECT at six times the seizure threshold under the effect of anesthesia. The treatment procedure is approximately 10 minutes, followed by a recovery period of approximately 30 minutes
15959627|NCT03191045|Diagnostic Test|MRI and concomitant perfused manometry of bowel motility|We will carry out serial cine MRI of the bowel. At the same time we will record perfused manometry readings of the bowel in healthy adult participants.
15959628|NCT03191032|Other|Early sensory re-education of the hand with a sensor glove model|Training Group patients were submitted to application of a three-month protocol for early sensory re-education of the hand using the sensor glove model developed by Mendes et al. (2011). Patients also received conventional physical therapy for this type of injury in a specialized hand therapy center in a university hospital. Control Group patients received only conventional physical therapy treatment. No home sensory re-education program was established for any group and the CG patients were not submitted to any protocol for early sensory re-education of the hand.
15959629|NCT03191019|Behavioral|Mobile-phone app for smoking cessation|Android App for smoking cessation
15959630|NCT03191006|Device|MEI BIN insoles|insoles
15959631|NCT03190993|Other|Sugar Sweetened Solid Treatment|Consume Sugar Sweetened Solid Treatment (product) daily.
15959632|NCT03190993|Other|Sugar Sweetened Beverage Treatment|Consume Sugar Sweetened Beverage Treatment (product) daily.
15959633|NCT03190980|Other|5% glucose|Neonates will receive 5% glucose, then heel prick wil be performed during which pain will be assessed
15959634|NCT03190980|Other|30% glucose|Neonates will receive 30% glucose, then heel prick wil be performed during which pain will be assessed
15959635|NCT03190980|Other|Placebo|Neonates will receive sterile water, then heel prick wil be performed during which pain will be assessed
15959638|NCT03190954|Drug|[11C]raclopride plus placebo|Placebo (po) will be given 60 minutes prior to [11C]raclopride scan to measure baseline dopamine D2 receptors. MRI scan to follow end of PET scan. Subject blind as to drug administration.
15959639|NCT03190954|Drug|[11C]raclopride plus drug|Methylphenidate 60 mg. po will be given 60 minutes prior to [11C]raclopride scan to measure striatal dopamine release. MRI scan to follow end of PET scan. Subject blind as to drug administration.
15959640|NCT03190954|Drug|[11C]NNC-112|[11C]NNC-112 PET scan obtained without any drug intervention to measure dopamine D1 receptors. Blind N/A
15959641|NCT03190941|Drug|Cyclophosphamide|Days -7 and -6: Cyclophosphamide 60 mg/kg/day x 2 days IV in 250 mL D5W infused simultaneously with mesna 15 mg/kg/day over 1 hour x 2 days.
15959642|NCT03190941|Drug|Fludarabine|Days -7 to -3: Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
15959643|NCT03190941|Biological|Anti-KRAS G12V mTCR PBL|Day 0: Cells will be infused intravenously on the Patient Care Unit over 20-30 minutes (2-4 days after the last dose of fludarabine).
15959644|NCT03190941|Drug|Aldesleukin|Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 3 days (maximum 9 doses).
15959645|NCT03190915|Drug|Trametinib|Given PO
15959646|NCT03190902|Behavioral|Attention Processing Training program (APT)|
15959647|NCT03190902|Behavioral|nonspecific computer training (n-ST)|
15959648|NCT03190889|Other|HOME|At home rehabilitation following ACL reconstructive surgery as described in the HOME arm.
15959649|NCT03190889|Other|TNMT|Standard of care, clinical rehabilitation following ACL reconstructive surgery with the addition of specified targeted neuromuscular training as described in the TNMT arm.
15959650|NCT03190876|Procedure|Variable drain usage|Influence of drain usage on seroma formation rate
15959651|NCT03190863|Behavioral|Motor imagery combined with neurofeedback (MINF)|"7 individuals with C6-C7 tetraplegia randomize in the experimental group consisting in motor imagery practice combined with visual neurofeedback (NF - i.e. performance of the imagined movement).
~Intervention consists in a total of 15 sessions repeated 3 times a week and lasting 5 weeks. Each session will last 45 minutes. An experienced physical therapist supervised all sessions. After each imagined movement, the NF based on brain activity measured by electroencephalography is display on a screen."
15959652|NCT03190863|Behavioral|Motor imagery (MI)|"7 individuals with C6-C7 tetraplegia randomized in the active comparator group consisting in motor imagery practice alone without visual NF. This means that the performance of the imagined movement is not displayed to the participants.
~Intervention consists in a total of 15 sessions repeated 3 times a week and lasting 5 weeks. Each session will last 45 minutes. An experienced physical therapist supervised all sessions."
15959653|NCT03190863|Behavioral|Control (C)|"7 individuals with C6-C7 tetraplegia randomized in the sham comparator group consisting in imagining geometric shapes by visualization. Shapes are successively displayed on a screen.
~Intervention consists in a total of 15 sessions repeated 3 times a week and lasting 5 weeks. Each session will last 45 minutes. An experienced physical therapist supervised all sessions."
15959654|NCT03190850|Other|Intervention|The device in which the breathing exercises will be performed will be adjusted with progressive loading aiming to improve muscular strength
15959655|NCT03190850|Other|Control|The device in which the breathing exercises will be performed will not be adjusted with progressive loading.
15959656|NCT03190824|Drug|OBP-301|A novel, replication-competent Ad5 based adenoviral construct that incorporates a human telomerase reverse transcriptase gene (hTERT) promoter.
15959657|NCT03190811|Biological|Anti-PD-1 plus DC-CIK|"Anti-PD-1 antibody treatment: Patients will receive pembrolizumab 100mg every three weeks until disease progression, unacceptable toxicity or patient refusal.
~DC-CIK Immunotherapy: Mononuclear cells were collected aseptically with blood cell separator composition apheresis, and cultured DC-CIK cells for 10-14 days. Cells were infused back to the patients in 3 times via intravenous infusion .Patients will received at least 2 cycles of DC-CIK Immunotherapy along with 4 dosage of anti-PD-1 antibody treatment. If the evaluation of the treatment is partial response or stable disease, additional cycles were eligible."
15959658|NCT03190811|Biological|Anti-PD-1 alone|Anti-PD-1 antibody treatment: Patients will receive pembrolizumab 100mg every three weeks until disease progression, unacceptable toxicity or patient refusal.
15959659|NCT03190798|Drug|Canagliflozin 300mg|"Canagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. It works by decreasing the amount of sugar the body absorbs, and increasing the amount of sugar that leaves the body in the urine.
~Administered in 300mg tablets."
15959660|NCT03190798|Drug|Placebo|Placebo for Canagliflozin
15959661|NCT03190785|Other|Benzoic acid washout and exposure|see above
15959662|NCT03190772|Other|Placebo nasal spray|The placebo nasal spray consists of sesame oil and does not contain any active drug.
15959663|NCT03190772|Other|Film sequence|All groups watch the film sequence that is supposed to induce sadness.
15959664|NCT03190746|Diagnostic Test|TaqMan SNP analysis|TaqMan SNP analysis of the YWHAH gene
15959665|NCT03190733|Drug|ATG|ATG will be intravenously infused via a central venous catheter in 4 or 5 days, from day -4 or -3 until day 0. The other conditioning drugs administered before transplantation include fludarabine (Flu), busulfan (Bu),cyclophosphamide (Cy). All transplant recipients will receive cyclosporine A (CsA), mycophenolate mofetil(MMF) for aGVHD prevention.
15959666|NCT03190720|Device|Mobile community|A mobile community based on smartphone application (WalkOn) which gives participants to information about their own steps and others'.
15959667|NCT03190707|Behavioral|Intervention|"Detection of ill-being: An extended consultation with the midwife. The midwife will screen the women for symptoms of anxiety, depression and personality disorders.
~Knowledge sharing: An additional midwife consultation accompanied by the health visitor. The aim of is sharing knowledge and transmission of information between the two sectors responsible for making a shared plan for the course of the process for the pregnant woman.
~Strengthen parenting skills through:
~Two visits by the health visitor before birth and eight after. The visits are based on the parent training program The Circle of Security, aiming at promoting a secure attachment between child and carer.
~Teaching the woman/couple on the importance of breast-feeding and how to succeed."
15959668|NCT03190694|Drug|Dapagliflozin 10mg|Tablet
15959669|NCT03190681|Drug|Ritalin 10Mg Tablet|ingestion of an oral single-dose
15959670|NCT03190668|Drug|Bolus dose of Cefazolin|Mode of Cefazolin administration will be a intermittent bolus
15959671|NCT03190668|Drug|Continuous Cefazolin drip|Mode of Cefazolin administration will be a continuous drip
15959672|NCT03190668|Device|Paraspinal muscle microdialysis catheters|Two dialysis probes will be inserted into a paraspinal muscle
15959673|NCT03190668|Device|Subcutaneous microdialysis catheters|Two dialysis probes will be inserted into a paraspinal subcutaneous region
15959674|NCT03190655|Device|Aluminaid|Aluminaid wound dressings is a hydrogel based wound dressing that is integrated with aluminium
15959675|NCT03190655|Device|Hydrogel|Hydrogel based wound dressing
15959676|NCT03190642|Drug|Methylprednisolone|Administration of 1000mg vs 125mg methylprednisolone preoperatively in orthognathic surgery.
15959677|NCT03190629|Device|High-flux hemodialysis|Hemodialysis treatment thrice weekly with the high-flux FX-100 dialyzer (Fresenius Medical Care, Bad Homburg, Germany; membrane: Helixone®; surface: 2.2 m2; UF coefficient: 73 ml/h mm Hg; ß2-microglobulin-sieving coefficient: 0.8; albumin-sieving coefficient: 0.001), including a minimum target dialysis dose (Kt/Vurea) ≥1.2 and a session length of 3.0 to 6.0 h. Hemodialysis treatments were performed with the 5008 hemodialysis system (Fresenius Medical Care).
15959678|NCT03190629|Device|On line-hemodiafiltration|Post-dilution on line-hemodiafiltration treatment thrice weekly with the high-flux FX-100 dialyzer (Fresenius Medical Care, Bad Homburg, Germany; membrane: Helixone®; surface: 2.2 m2; UF coefficient: 73 ml/h mm Hg; ß2-microglobulin-sieving coefficient: 0.8; albumin-sieving coefficient: 0.001), including a minimum target dialysis dose (Kt/Vurea) ≥1.2 and a session length of 3.0 to 6.0 h. Post-dilution on line-hemodiafiltration treatments were performed with the 5008 hemodialysis system (Fresenius Medical Care), with automatic adjustment of the substitution fluid flow rate for maximising substitution volume while simultaneously avoiding haemoconcentration and filter clotting.
15959679|NCT03190616|Drug|apatinib|apatinib 500mg/qd, 28d/cycle
15959680|NCT03190603|Drug|Celecoxib|Continue celecoxib 400mg/day for 3months in axial spondyloarthritis patients.
15959684|NCT03190577|Genetic|blood sample|two 5 ML EDTA tubes of blood will be collected once by patient
15959685|NCT03190551|Other|retroclavicular approach|Retroclavicular approach for ultrasound guided infraclavicular brachial plexus block
15959686|NCT03190551|Other|costoclavicular approach|costoclavicular approach for ultrasound guided infraclavicular brachial plexus block
15959687|NCT03190538|Other|No intervention|There will be no specific intervention to these paediatric NASH patient
15959688|NCT03190525|Other|Quality of life questionnaires|QLQ-C30
15959689|NCT03190512|Other|Psychological measurements|Four questionnaire tests for depression, body image, self-esteem, and anxiety was performed baseline and after 6 weeks.
15959690|NCT03190499|Other|Family based assessment|Family of the children will be assessed with questionnaires about their child health condition.
15959691|NCT03190486|Other|functional Magnetic Resonance Imaging (fMRI)|During fMRI, healthy volunteers will listen 80 baby's cry.
15959692|NCT03190473|Device|DES|PCI with implantation of a DES
15959693|NCT03190460|Other|Cognitive Training|Web-based cognitive training intervention targeting specific cognitive tasks. Subjects complete 3 training sessions per week with at least 24 hours in between sessions.
15959694|NCT03190460|Other|Technology-based Education|Subjects complete 16 web-based educational modules on healthy aging content. Following each module, subjects complete a learning reflection.
15959695|NCT03190447|Device|Aquacel Surgical®|Measuring the skin integrity with each dressing and the patient satisfaction
15959696|NCT03190447|Device|Mepilex Border post-op®|Measuring the skin integrity with each dressing and the patient satisfaction
15959697|NCT03190447|Device|Opsite post-op visible®|Measuring the skin integrity with each dressing and the patient satisfaction
15959698|NCT03190447|Device|Urgotul ABSORB border silicona®|Measuring the skin integrity with each dressing and the patient satisfaction
15959699|NCT03190447|Device|Conventional dressing|Measuring the skin integrity with each dressing and the patient satisfaction
15959700|NCT03190434|Device|AL-SENSE|The AL-SENSE reacts differently when in contact with amniotic fluid than it does with urine. The indicator changes color to blue-green and fades back to yellow in case of urine and changes to stable blue-green in case of amniotic fluid.
15959701|NCT03190421|Diagnostic Test|Expanded Urinary Culture|involves the inoculation of 100X (0.1mL) more urine onto diverse types of media (BAP, chocolate agar, colistin and nalidixic acid (CNA) agar, CDC anaerobe 5% BAP) with incubation in more environments and temperatures (5% CO2 at 35°C for 48 h, aerobic conditions at 35°C and 30°C for 48 h, Campy gas mixture (5% O2, 10% CO2, 85% N) or anaerobic conditions at 35°C for 48 h). The level of detection for EQUC is 10 CFU/mL, represented by 1 colony of growth on any of the plates. EQUC is designed to isolate a broad array of Gram-negative and Gram-positive bacteria, including anaerobes and fastidious bacteria that grow slowly.
15959702|NCT03190421|Diagnostic Test|Standard Urine Culture (SUC)|involves inoculation of 0.001 mL of urine onto 5% sheep blood agar plate (BAP) and MacConkey agar plate with the plates being incubated aerobically at 35°C for 24 h. Thus, the level of detection for standard culture is 103 CFU/mL, represented by 1 colony of growth on either plate. Standard culture is designed specifically to grow Gram-negative rods, especially UPEC.
15959703|NCT03190408|Other|Fluids|Fluids Administered in Shock
15959704|NCT03190395|Procedure|CPVI Group|CPVI Group:The ablation strategy of Circumferential pulmonary vein isolation (CPVI)will be operated on 60 patients with paroxysmal atrial fibrillation.
15959705|NCT03190395|Procedure|CPVI+LARA Group|CPVI+LARA Group: The ablation strategy of Circumferential pulmonary vein isolation combine with Left atrium roofline ablation(CPVI+LARA) will be operated on 60 patients with paroxysmal atrial fibrillation.
15959706|NCT03190382|Other|Decision Support Tool|Patients enrolled in the study will receive the decision tool prior to the first PAD clinic visit and the medical decision making conversation with the provider.
15959707|NCT03190369|Device|Hylan G-F 20 (GZ402662/SAR402662)|"Pharmaceutical form: Solution for injection
~Route of administration: Intra articular"
15959708|NCT03190369|Drug|Placebo|"Pharmaceutical form: Solution for injection
~Route of administration: Intra articular"
15959709|NCT03190356|Device|Soberlink Cellular Device|Soberlink Cellular Device delivers real-time blood alcohol results to people who support individuals in recovery. MAP platform helps monitor and support compliance with discharge plans while providing tools to improve outcomes for behavioral health diagnoses.
15959710|NCT03190343|Procedure|cholangio-pancreatoscopy|
15959711|NCT03190330|Drug|Ibrutinib 420 mg|Ibrutinib capsule administered orally at a dose of 420 mg for CLL participants.
15959712|NCT03190330|Drug|Ibrutinib 560 mg|Ibrutinib capsule administered orally at a dose of 560 mg for MCL participants.
15959713|NCT03190317|Other|HIV-infected Veterans who use MHV|The investigators will use information from Veteran medical records to assess the relationship between Veteran HIV health care outcomes and the use of MHV. Next, the investigators will interview Veterans to understand why MHV is used. Finally, the investigators will create an intervention based on the information learned that will encourage use of MHV and ask Veterans to test it out.
15959714|NCT03190317|Other|HIV-infected Veterans who do not use MHV|The investigators will use information from Veteran medical records to assess the relationship between Veteran HIV health care outcomes and the use of MHV. Next, the investigators will interview Veterans to understand why MHV is not used. Finally, the investigators will create an intervention based on the information learned that will encourage use of MHV and ask Veterans to test it out.
15959752|NCT03190031|Other|Resistance inspiratory muscle training|Training program of the inspiratory muscles in resistance by using repeated inspiratory maneuvers against a resistance
15960286|NCT03185910|Behavioral|MBCP education|MBCP education involves mindfulness breathing and other skills with mindfulness meditations.
15959715|NCT03190317|Other|Providers and staff of HIV-infected veteran|The investigators will interview providers and staff to understand why they think Veterans at their health system use or do not use the MHV portal for self management. The investigators will create and test an intervention based on information learned that will encourage use of MHV among Veterans and providers/staff.
15959716|NCT03190304|Drug|Neprilysin|To compare the effect of Enalapril and Neprilysin on exercise tolerance in patients with heart failure
15959717|NCT03190304|Drug|Enalapril|To compare the effect of Enalapril and Neprilysin on exercise tolerance in patients with heart failure
15959718|NCT03190278|Biological|UCART123v1.2|Allogeneic engineered T-cells expressing anti-CD123 Chimeric Antigen Receptor
15959719|NCT03190265|Drug|Cyclophosphamide|Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Cyclophosphamide (200 mg/m2) will be administered IV on day 1 of Cycles 1 and 2.
15959720|NCT03190265|Drug|Nivolumab|Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Nivolumab (360 mg) will be administered IV on day 1 of Cycles 1-6.
15959721|NCT03190265|Drug|Ipilimumab|Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Ipilimumab (1 mg/kg) will be administered IV on Day 1 of Cycles 1, 3, and 5.
15959722|NCT03190265|Drug|GVAX Pancreas Vaccine|Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). Vaccine will be administered on Day 2 of Cycles 1 and 2.
15959723|NCT03190265|Drug|CRS-207|Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 109 CFU) will be administered IV on Day 2 of Cycles 3-6.
15959724|NCT03190265|Drug|CRS-207|Patients will receive treatment every 3 weeks for 6 cycles of treatment within a course (total of 18 weeks). CRS-207 (1 × 109 CFU) will be administered IV on Day 2 of Cycles 1-6.
15959725|NCT03190252|Other|Exposure to oxygen partial pressure of 130 kPa|Open sea diving to a maximum depth of 100 msw while breathing Trimix.
15959726|NCT03190252|Other|Exposure to ambient pressure of maximum 11 ATA|Open sea diving to a maximum depth of 100 msw while breathing Trimix.
15959727|NCT03190239|Drug|Apatinib|Apatinib 250mg qd
15959728|NCT03190239|Drug|Pemetrexed|Pemetrexed 500mg/m2 qm
15959729|NCT03190226|Procedure|L-PRF membranes|split-mouth design, randomized L-PRF membranes vs. free gingival graft
15959730|NCT03190226|Procedure|Free Gingival Graft|split-mouth design, randomized L-PRF membranes vs. free gingival graft
15959731|NCT03190213|Drug|Pembrolizumab Injection|Pembrolizumab at a dose of 200 mg will be administered as an IV infusion over 30 minutes every 3 weeks until disease recurrence or discontinuation due to unacceptable toxicity for a maximum of 2 years. We anticipate on average patients will remain on treatment for approximately 24 weeks.
15959732|NCT03190200|Device|MRI|No intervention - observational trial using MRI
15959733|NCT03190187|Other|Spinal Manipulation|Spinal manipulation based on orthopaedic manual therapy approach
15959734|NCT03190187|Other|Sham manipulation|Patients will receive simulated spinal manipulation without force application
15959735|NCT03190174|Drug|Nab-Rapamycin|Escalating doses of ABI-009 will be given IV over 30 min for 2 of every 3 weeks beginning Day 8 Cycle 2. Only nivolumab will be given in Cycle 1. At Dose Level 1, 3-6 patients will receive 56 mg/m2; at Dose Level 2, 3-6 six patients will receive 75 mg/m2; and at Dose Level 3, 3-6 patients will receive 100 mg/m2.
15959736|NCT03190174|Biological|Nivolumab|A defined dose of nivolumab, 3 mg/kg, will be given IV over 30 minutes q 3 weeks
15959737|NCT03190161|Behavioral|Music session|Participants will be asked to refrain from smoking from 24 hours before the music listening session as confirmed by breath carbon monoxide level <6 ppm on the day of the session. They will be contacted by phone or in person at the clinic as a reminder prior.
15959738|NCT03190148|Other|OGTT|A standardized 75g oral Glucose tolerance test was accomplished.
15959739|NCT03190148|Other|IVGTT|For the exact assessment of Glucose metabolism in the study participants an intravenous Glucose tolerance test (IVGTT) was accomplished
15959740|NCT03190148|Other|1H-magnetic resonance spectroscopy|For the assessment of the ectopic lipid content in the liver, heart and the muscle a 1H-magnetic resonance spectroscopy was accomplished three to six months after delivery
15959741|NCT03190135|Behavioral|BOKS: 2 day a week before-school physical activity program|Students participate in BOKS, a before-school physical activity program for 12 weeks, 2 times per week.
15959742|NCT03190135|Behavioral|BOKS: 3 day a week before-school physical activity program|Students participate in BOKS, a before-school physical activity program for 12 weeks, 3 times per week.
15959743|NCT03190122|Procedure|surgical excision of the tumor|Neurocognitive Outcome Assesment in Patients With Peri-optic Meningiomas After Excision With Or Without Pealing Of The Outer Layer Of The Cavernous Sinus: A Randomized Controlled Single Blinded Trial. [NCT ID not yet assigned]
15959744|NCT03190096|Procedure|SVC isolation|After PVI ablation SVC will be performed. The CB will be retrieved to the right atrium and the achieve catheter will be advanced in the SVC. The CB will be inflated in the right atrium and advanced towards the ostium of the SVC to occlude the vessel
15959745|NCT03190083|Device|2-dimensional mammogram|This is standard of care for breast cancer diagnosis. The new breast cancer patients will be scheduled for the mammogram after diagnosis at the time of surgical appointment. The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram.
15959746|NCT03190083|Device|digital breast tomosynthesis (DBT)|The radiation dose from this/these procedure(s) will be no more than 0.4mSv for a bi-lateral breast tomosynthesis. The new breast cancer patients will be scheduled for the mammogram after diagnosis at the time of surgical appointment. The radiologist reviewing the tomosynthesis images will be separate and blinded from the radiologist who reviewed the initial 2-D mammogram.
15959747|NCT03190070|Dietary Supplement|Ingestion of protein|Oral protein load as a physiological stimulus to temporarily increase glomerular filtration rate
15959748|NCT03190057|Device|BIOFREEDOM™ FAMILY stent|Percutaneous coronary intervention with BIOFREEDOM™ FAMILY stent
15959749|NCT03190044|Dietary Supplement|PACR|Daily assumption of PACR for a 3-month period
15959750|NCT03190044|Dietary Supplement|Placebo|Daily assumption of placebo
15959751|NCT03190031|Other|Endurance respiratory muscle training|Training program of the respiratory muscles in endurance by using sustained isocapnic hyperpnea
15959753|NCT03190018|Device|lCarry Life System Peritoneal Dialysis (CLS PD)|The assigned intervention is with the CLS PD device in patients currently receiving peritoneal dialysis for the duration of one study session. A temporary Pigtail catheter is inserted on the same morning as the study session and removed after the session on the same day.
15959754|NCT03190005|Drug|clopidogrel|routine Dual antiplatelet therapy after stent implantation, then check PRU(platelet reactivity unit)
15959755|NCT03190005|Drug|Placebos|no medication, healthy subjects.
15959756|NCT03189992|Drug|Bushen-Jianpi Dedoction|A traditional chinese medicine prescription
15959757|NCT03189992|Drug|cinobufotalin injection|an effective Chinese preparation to treat malignant tumor.
15959758|NCT03189979|Behavioral|Physical activity and healthy eating intervention|Using a community-based participatory approach, BGC staff and academic researchers developed intervention components informed by formative studies and based on a social ecological theory framework. Components included healthy eating and physical activity policy implementation, staff training, a challenge/self-monitoring program for healthy behaviors, a peer-coaching program for healthy behaviors, and a social marketing campaign.
15959759|NCT03189966|Procedure|transversalis fascia plane block|With the patient in a supine position, the needle is advanced from the anterior using an in-plane technique. A linear ultrasound probe is orientated transversely over the lateral abdomen between the iliac crest and the costal margin. Local anesthetic is injected to separate the transversalis fascia from the transversus muscle. The correct needle position was confirmed by injection of 2 ml of normal saline solution that was spreading anterio-posteriorly between the anterior border of QLM and its fascia, in addition to a minimal anterior spread in TAP plane. After negative aspiration, 0.8 ml/Kg of ropivacaine 0.3%was injected.
15959760|NCT03189966|Procedure|quadratus lumborum block|The needle is directed in the posterior to anterior orientation with the practitioner standing behind the patient. The triangular quadratus lumborum (QL) muscle is adherent to the apex of the transverse process of L3 vertebra. Using the Shamrock method, the needle penetrates the QL muscle with an in-plane approach from the posterior side of the ultrasound probe. The target point is the inter fascial plane between the QL and the psoas major muscle just deep to the transversalis fascia, in order to lessen the risk of unintentional penetration of the peritoneal cavity contrary to the technique. The correct needle position was confirmed by injection of 2 ml of normal saline solution that was spreading anterio-posteriorly between the QL and the psoas major muscle. After negative aspiration, 0.8 ml/Kg of ropivacaine 0.3%was injected.
15959761|NCT03189953|Radiation|68Ga-NODAGA-exendin 4 PET/CT|68Ga-NODAGA-exendin 4 PET/CT
15959762|NCT03189940|Behavioral|Life style modification by using and app with a wrist-worn activity tracker|The mobile app was designed to collect daily lifestyle data by wearing a wrist activity tracker and reporting dietary intake. At the visit after 2 weeks of use, a summary of the lifestyle was displayed on the hospital EMR and reviewed by both physicians and app users. Further lifestyle modification was encouraged on the basis of the electronically collected data.
15959763|NCT03189940|Behavioral|Conventional Life style modification|Physician's usual consultation for life style modification at 0 week, and 2 weeks of enrollment
15959764|NCT03189927|Device|BD-Covered esophageal stent|a biodegradable covered stent is implanted to achieve a long-term relieve of dysphagia in refractory benign esophageal strictures
15959765|NCT03189914|Drug|RX-3117|RX-3117 will be administered orally in combination with Abraxane.
15959766|NCT03189901|Drug|Regular management+Levosimendan|Patients are treated with regular management recommended in guidelines and levosimendan.
15959767|NCT03189888|Device|apheresis|
15959768|NCT03189875|Other|Standard of Care|Participants will be followed as per local routine clinical practice
15959769|NCT03189862|Behavioral|Motor Skills Intervention|"The behavioral motor skills intervention (CHAMP) is an intervention strategy that uniquely addresses differences in children's developmental levels on an individualized basis. CHAMP does not equate to a one size fits all approach. Children will be in an environment that promotes opportunities for them to develop improvements in motor skills based on their specific individual needs and choices. The CHAMP intervention promotes a mastery climate that allows each individual child to be successful and learn while promoting intrinsic motivation and autonomy. CHAMP will be implemented 4x/week for 30 minutes across ≈30 weeks for ≈3000 minutes of intervention time."
15959770|NCT03189836|Biological|ACTR707|autologous T cell product
15959771|NCT03189836|Biological|rituximab|CD20-directed cytolytic antibody
15959772|NCT03189823|Device|Specify, model 3998, Medtronic Inc., Minneapolis, MN, USA|In MCS, an electrode is placed perpendicular to the central sulcus in the epidural space (Specify, model 3998, Medtronic Inc., Minneapolis, MN, USA) in order to obtain pain relief.
15959773|NCT03189810|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|On Day 1, the resting motor threshold (RMT) will be determined according to previous published methods [Cardenas-Morales et al. 2013] and the rTMS will be delivered at an intensity of 90% of the participant's RMT. rTMS will be administered at 20 Hz (25 trains, 30 pulses per train, 30 second intertrain interval).
15959774|NCT03189810|Device|Sham Repetitive Transcranial Magnetic Stimulation (rTMS)|On Day 1, the resting motor threshold (RMT) will be determined according to previous published methods [Cardenas-Morales et al. 2013] and the Sham rTMS will be delivered at an intensity of 90% of the participant's RMT. rTMS will be administered at 20 Hz with the B65 placebo coil (25 trains, 30 pulses per train, 30 second intertrain interval).
15959775|NCT03189810|Behavioral|Weekly Counselling Session|In order to support participants in their abstinence plan, individual weekly sessions of supportive counselling will be administered over the course of the study on 1 time per week over 4 weeks (28 days of abstinence).
15959776|NCT03189797|Other|tailored preventive program|In the study group they were given a preventive program as homecare program including tooth brushing 2/day with a fluoride toothpaste( 5000 ppm F) following the instructions in addition to fluoride mouth rinse. For the clinical approach motivational engagement was done by discussing with patients how to improve oral health behavior including amount of sugar, fibrous food and junk food. This in addition to pits and fissures sealant, F- varnish 2 times /year. and application of fluoride varnish every 6 months and dietary intake interventions.
15959777|NCT03189784|Other|mobilization with movement techniques|patient will receive an anteroposterior stimuli in the talus in order to restore the range of motion
15959778|NCT03189771|Procedure|occlusal surface reduction|occlusal surface reduction after single visit root canal treatment
15959942|NCT03188549|Other|AniosGel 85 NPC|Hand hygiene formula
15959779|NCT03189758|Other|Observational Control Diet|Participants will follow their usual or normal diet for 30 days (days 1-30) while under study observation.
15959780|NCT03189758|Other|Controlled Dietary Sodium Restriction|Participants will be provided with all meals and snacks daily, for 30 days (days 31-60). These meals should meet KDQOI guidelines for energy and protein (30-35 kcal/kg & 1.2 g/kg) as well as low phosphorus, potassium, and sodium. The meals are formulated to less than 600-800 mg sodium each (<2,000g/day) and will be ordered and delivered through momsmeals.com
15959781|NCT03189745|Biological|MenACWY-TT|Single dose of MenACWY-TT given 10 years after first vaccine with either MenACWY-TT or Mencevax ACWY
15959782|NCT03189732|Drug|Metformin Oral|
15959783|NCT03189732|Drug|Metformin local in AT|
15959784|NCT03189732|Other|Exercise|
15959785|NCT03189719|Biological|Pembrolizumab|200 mg administered IV Q3W on Day 1 of each 3-week cycle, up to 35 administrations.
15959786|NCT03189719|Drug|Placebo|Placebo to pembrolizumab (saline) administered IV Q3W on Day 1 of each 3-week cycle, up to 35 administrations.
15959787|NCT03189719|Drug|Cisplatin|80 mg/m^2 administered IV Q3W on Day 1 of each 3-week cycle. Duration of cisplatin treatment will be capped at 6 doses.
15959788|NCT03189719|Drug|5-FU|800 mg/m^2/day (4000 mg/m^2 total per cycle) administered as continuous IV infusion on Days 1 to 5 (120 hours) of each 3-week cycle, or per local standard for 5-FU administration, up to 35 administrations.
15959793|NCT03189693|Other|PVB|nerve stimulator-guided PVB will be performed at two levels
15959794|NCT03189693|Other|Placebo|nerve stimulator-guided PVB containing placebo will be performed at two levels
15959795|NCT03189693|Other|GA|All patients will receive general anesthesia.
15959796|NCT03189693|Other|Anesthetic injections|4 mL of the local anesthetic mixture is injected at each injection site. Each 20 mL of the local anaesthetic mixture contains: 8mL lidocaine 2%, 8 mL lidocaine 2% with epinephrine 5µg/mL and 4 mL bupivacaine 0.5%.
15959797|NCT03189680|Other|Exercise therapy|3-week-long intervention, administered daily, targeted postural instability and mobility using at-limit intensity sensorimotor and visuomotor agility training
15959798|NCT03189667|Device|Vessel preparation with angioplasty|"Vessel preparation with Pre dilatation:
~All lesions to be predilated with high pressure balloons until waist is obliterated.
~At least two minutes dilatation.
~Balloon sizing: not to exceed the average diameter of adjacent normal appearing non-aneurysmal segments by more than 25%.
~Multiple lesions:
~To be treated with single balloon if possible.
~To be treated with multiple inflation if cannot be covered with single balloon."
15959799|NCT03189667|Device|Plain balloon angioplasty|"Plain balloon angioplasty
~Vessel treatment with additional Plain balloon angioplasty:
~Inflation to nominal pressure for at least 1 minute.
~Balloon size: similar to predilation balloon."
15959800|NCT03189667|Device|Drug coated balloon angioplasty|"Lutonix® Drug Coated Balloon: The balloon is coated with a specialized formulation that includes the drug, paclitaxel. The paclitaxel coating is evenly distributed across the working length of the balloon at a surface concentration of 2 μg/mm2. The key functional characteristic of the formulation is to allow for release of paclitaxel to the tissue of the vascular wall during inflation.
~Inflation to nominal pressure for at least 1 minute.
~Balloon size: similar to the predilation balloon.
~New drug coated balloon will be required for each lesion."
15959801|NCT03189654|Device|Non-invasive ventilation|Non-invasive Ventilation for a Minimum of 8 h per day after pleurocentesis
15959802|NCT03189641|Device|Cilostazol eluting stent system (CES-1)|Implantation of drug eluting stent
15959803|NCT03189628|Biological|stromal vascular fraction|The adipose tissue(no less than 40ml) in abdomen will be harvested and digested at 37 °C for (45-60) min with (0.125-1.5)mg/ml collagenase . After filtration and centrifugation at the speed of (700-1500)g, mature adipocytes are separated from the cell pellet. The pellet then is treated with saline twice to remove cell fragment and rudimental collagenase . The harvested pellet is stromal vascular fraction (SVF) The SVF was resuspended in 1 ml saline and transplanted for 3 area including the forehead、palpebra inferior and crow's-feet.
15959804|NCT03189628|Drug|Saline|1 ml saline was injected for 3 area including the forehead、palpebra inferior and crow's-feet.
15959805|NCT03189615|Drug|Lu AF35700|Single oral dose of 10 mg Lu AF35700
15959806|NCT03189589|Drug|GSK2269557 500 µg|GSK2269557 is a potent and highly selective inhaled Phosphoinositide 3 Kinase delta inhibitor. Single dose of GSK2269557 500 µg will be administered to randomized subjects via inhalation route using ELLIPTA DPI.
15959807|NCT03189589|Drug|GSK2269557 750 µg|GSK2269557 is a potent and highly selective inhaled Phosphoinositide 3 Kinase delta inhibitor. Single dose of GSK2269557 750 µg will be administered to randomized subjects via inhalation route using ELLIPTA DPI.
15959808|NCT03189576|Diagnostic Test|blood draw|
15959809|NCT03189563|Drug|DA-9805 45mg|DA-9805 15mg tid
15959810|NCT03189563|Drug|DA-9805 90mg|DA-9805 30mg tid
15959811|NCT03189563|Other|Placebo|Placebo, tid
15959812|NCT03189550|Procedure|ERAS perioperative care|Standard of care implementation of multi-modal evidence-based care pathway, including standardized preoperative preparation (medical and diet), perioperative goal-directed fluid therapy, multi-modal perioperative pain management, postoperative nausea and vomiting prevention, surgical care and bowel isolation, and surgical site infection prevention
15959813|NCT03189550|Procedure|Standard perioperative care|Standard perioperative care prior to implementation of ERAS care pathway
15959814|NCT03189550|Procedure|Noninvasive hemodynamic monitoring|Standard of care perioperative noninvasive hemodynamic monitoring with the ClearSight System (Edwards LifeSciences)
15959815|NCT03189537|Drug|Ingavirin (Imidazolyl Ethanamide Pentandioic Acid)|Broad-spectrum antiviral agent
15959816|NCT03189537|Drug|Placebo oral capsule|Placebo capsule to match Ingavirin capsule
15959818|NCT03189511|Drug|Fluvastatin|Fluvastatin 40 mg twice daily per mouth for 14 days.
15959819|NCT03189498|Drug|JNJ-64041575|All participants will receive a single oral dose of 1,000 mg JNJ-64041575 (4*250 mg tablets) on Day 1.
15959943|NCT03188549|Other|Softa-Man (Braun)|Hand hygiene formula
15959820|NCT03189485|Drug|the radiotracer 18F-AV-1451|Subjects will receive a single IV bolus injection target dose of approximately 370 MBq (10 mCi ± 20%) of 18F-AV-1451 At approximately 75 minutes post dose, scanning will begin. An approximately 30-minute acquisition (six 5 minute intervals) will be performed
15959821|NCT03189472|Device|Active tDCS|low amplitude direct currents to induce changes in cortical excitability. tDCS produces current intensities in the brain orders of magnitude below other stimulation techniques such as transcranial magnetic stimulation (TMS) or electroconvulsive therapy (ECT)
15959822|NCT03189472|Device|Sham tDCS|The device will be programmed to deliver either active or sham tDCS (all study personnel and participants will be blinded), and operated with unlock codes provided by the study technician daily to release one session
15959823|NCT03189459|Behavioral|Home Visit Program|RC: Informed consent discussion, documentation RN: UPDRS I-II, vitals, medication reconciliation, patient medical history and comorbidities RN and SW: Home safety assessment SW: Psychosocial assessment of dyad, HADS, assessment of mobility and homebound status, needs assessment of dyad, caregiver medical history and comorbidities RC: patient and caregiver short MoCA, PD-Rx, health literacy assessment, satisfaction surveys; patient PDQ-39/PDQ-8
15959824|NCT03189459|Behavioral|Caregiver Mentorship Program|"Both mentors and mentees will be completing this program:
~Mentors will be asked to complete: 1) a Mentor Training - One 5-hour session at Rush University Medical Center; and 2) two 16-week periods of mentoring someone who is currently a caregiver for a patient with Parkinson's Disease
~Caregivers mentees will be asked to complete a 16 week mentorship program with their assigned mentor"
15959825|NCT03189446|Radiation|Vaginal Cuff Brachytherapy|Within 12 weeks of surgery. Either LDR or HDR brachytherapy will be permitted
15959826|NCT03189446|Drug|Carboplatin|Carboplatin IV on day 1 of a 21 day cycle for 3 cycles
15959827|NCT03189446|Drug|Paclitaxel|Paclitaxel IV on days 1,8 and 15 of a 21 day cycle for 3 cycles
15959828|NCT03189433|Drug|Ryanodex (dantrolene sodium) for injectable suspension|Ryanodex (dantrolene sodium) for injectable suspension, 250 mg/vial to be reconstituted in 5 mL of sterile water for injection to yield a 50 mg/mL suspension that will be administered as a rapid IV push of 2.5 mg/mL.
15959829|NCT03189420|Procedure|Tumor resection|The tumors will be resected in routine therapeutic surgeries
15959830|NCT03189407|Dietary Supplement|Moringa oleifera tea|
15959831|NCT03189394|Behavioral|PRIDE|A couples curriculum that is relationship-focused and in-person, aimed at helping to reduce the odds of a composite HIV risk variable among gay couples.
15959832|NCT03189394|Behavioral|ePRIDE|A couples curriculum that is relationship-focused and online, aimed at helping to reduce the odds of a composite HIV risk variable among gay couples.
15959833|NCT03189394|Behavioral|Men's Health|A men's health curriculum that is individualized and in-person, aimed at helping participants to focus on gay men's health.
15959834|NCT03189381|Radiation|Cohort A|Cohort A - WBRT dose = 25 Gy, SIB dose = 42 Gy, # of daily fractions = 10, SIB dose in EQD2 = 49.7 Gy
15959835|NCT03189381|Radiation|Cohort B|Cohort B - WBRT dose = 20 Gy, SIB dose = 40 Gy, # of daily fractions = 8, SIB dose in EQD2 = 50.0 Gy
15959836|NCT03189368|Device|Activation of multi-site pacing capability on CRT devices|"Instead of administering a single LV pulse at the most (electrically) delayed segment of the ventricle, multi-site pacing allows for a more detailed sculpting of the LV activation sequence. Based on the MPP-IDE study results, activation of the antero-lateral wall, or at least its most delayed segments, closely followed by a pulse to the apex and then by a right ventricular one will yield favorable results in terms of hemodynamics and clinical parameters.
~Programming features:
~Interpolar distance for the first left ventricular pulse >30mm (i.e. non-sequential poles used)
~Nearly simultaneous (Δt=5msec) second left ventricular pulse and
~Threshold of ≤3.5V@0.5msec"
15959837|NCT03189355|Procedure|Blood sampling|"D1 PTP1B + zonulin +PAXGENE tube +aprotinin tube
~D4 zonulin"
15959838|NCT03189355|Procedure|Bioelectrical impedance vector analysis|"D1
~D4"
15959839|NCT03189355|Procedure|Muscular echography|"D1
~D4"
15959840|NCT03189342|Behavioral|Single task training|The participants in single task training received 30 minutes single task balance and gait exercises, 3 times a week for 4 weeks. The program included static and dynamic balance exercises. Static balance exercises involved body stability (e.g., standing legs open and closed, standing with eyes closed, tandem standing, standing on foam surface and one leg standing, standing while throwing and catching a ball ), forward and backward weight shifting and keeping standing position while being disturbed by external perturbation. Dynamic balance exercises included tandem walking, walking to different direction (backward, side to side), transfer activities (from 1 chair to another) and sit to stand 5 times
15959841|NCT03189342|Behavioral|dual task training|The participants practiced 30 minutes balance and gait exercises while simultaneously performing cognitive tasks. The program included static and dynamic balance exercises. Static balance exercises involved body stability, forward and backward weight shifting and keeping standing position while being disturbed by external perturbation. Dynamic balance exercises included tandem walking, walking to different direction, transfer activities and sit to stand 5 times. The participants practiced cognitive tasks while simultaneously performing balance and gait exercises. The cognitive tasks included visual attention, auditory attention, planning, verbal fluency, simple mental math and maze activities. At each week, participants performed different type of activities which were designed to foster the executive functions: (1) Visual and auditory attention, (2) Planning and verbal fluency, (3) Simple math problems (4) Visual and auditory attention, planning, verbal fluency, math problems
15959842|NCT03189342|Behavioral|exercise-cognitive activity combined training|The participants first practiced 30 min of cognitive activities then performed 30 min of balance and gait exercises after 5 min of resting.The program included static and dynamic balance exercises. Static balance exercises involved body stability, forward and backward weight shifting and keeping standing position while being disturbed by external perturbation. Dynamic balance exercises included tandem walking, walking to different direction, transfer activities and sit to stand 5 times. The cognitive tasks included visual attention, auditory attention, planning, verbal fluency, simple mental math and maze activities. At each week, participants performed different type of activities which were designed to foster the executive functions: (1) Visual and auditory attention, (2) Planning and verbal fluency, (3) Simple math problems (4) Visual and auditory attention, planning, verbal fluency, math problems.
15959944|NCT03188549|Other|Septol|alcohol-based hand rub
15959945|NCT03188536|Other|No Intervention|As it was an observational study, no intervention was administered in this study.
15959843|NCT03189329|Drug|2% lidocaine hydrochloride|Retrobulbar block was performed with 5 ml of 2% lidocaine hydrochloride (AritmalR, Osel, Istanbul, Turkey) in Group L patients. The block was performed by the same practitioner (fourth year assistant of Ophthalmology Department) using inferotemporal approach as described by Sanderson using 27 gage disposable needles (Atkinson Retrobulbar NeedleR, Asico, USA)
15959844|NCT03189329|Drug|0.5% levobupivacaine|and 5ml of 0.5% levobupivacaine (ChirocaineR, Abbvie, Chicago, USA) in Group LB patients. The block was performed by the same practitioner (fourth year assistant of Ophthalmology Department) using inferotemporal approach as described by Sanderson using 27 gage disposable needles (Atkinson Retrobulbar NeedleR, Asico, USA)
15959845|NCT03189316|Other|peritoneal fluid and blood sample|Peritoneal fluid sample obtained from peritoneal dialysis fluid of patients with chronic renal insufficiency and blood sample or Peritoneal fluid obtained from coelioscopy for exploration of ovarian cysts and blood cell
15959846|NCT03189303|Device|Primary Uncemented Total Hip Arthroplasty|The study devices are the Pinnacle Hip System acetabular cup with a Summit, Actis, or Corail femoral stem
15959847|NCT03189290|Procedure|posterior Quadratus Lumborum Block (QLB)|Procedure (experimental): ultrasound guided posterior Quadratus Lumborum Block (QLB) Procedure (experimental): Sham Block
15959848|NCT03189264|Procedure|percutaneous nephrolithotomy for kidney stones|Use of various methods of access to the renal collecting system (pneumatic balloon dilatation vs. traditional technique with coaxial dilators) during percutaneous nephrolithotomy for treatment of kidney stones greater than 2 cm.
15959849|NCT03189251|Other|Dietary intakes|Analysis of association between consumption of high excess free fructose (EFF) beverages (high fructose corn syrup sweetened soft drinks, fruit drinks, apple juice)
15959850|NCT03189238|Biological|Peri-urethral and clitoral injections|Peri-urethral and clitoral injections
15959851|NCT03189225|Other|Capillary And Venous Accuracy|Capillary And Venous Accuracy: LifeScan Products vs Hospital Reference instrument and LifeScan reference instrument (YSI 2300)
15959852|NCT03189212|Behavioral|Usual Care Visit|Routine 6-month follow up appointment at the NYULMC transplant center
15959853|NCT03189212|Behavioral|Telemedicine Visit|TM visit conducted at the patient's dialysis unit as a replacement to usual 6 month routine f/u visit
15959854|NCT03189199|Other|a cohort using Dazhuhongjingtian injection|All patients will be measured and assessed at the time Dazhuhongjingtian Injection is administered to them until they discharge. Patients using Dazhuhongjingtian Injection will be registered on a registration form including disease background, Dazhuhongjingtian Injection's administration, and extraction information from hospital information system. An adverse event or drug adverse reaction form also will be used to describe any doubted symptoms or signs from patients. A judgment will be made by doctors directly and a further analysis will be conducted by researchers to decide those potential side effects of Dazhuhongjingtian Injection.
15959855|NCT03189186|Drug|Pembrolizumab Injection [Keytruda]|Same as arm description
15959856|NCT03189186|Procedure|Cryoablation|Cryoablation uses liquid argon in metal needles to freeze tumors. Tumor cells are ruptured due to the forming ice crystals and die. Cryoablation is standardly used in tumors less then 4cm in diameter.
15959857|NCT03189186|Procedure|Nephrectomy|Nephrectomy is the surgical excision of either the entire kidney or a small portion of the kidney. Nephrectomy is standardly used to treat renal cell cancer.
15959858|NCT03189173|Device|Oral appliance|"An oral appliance (dental mouthpiece) will be used to improve upper airway patency. Patients who do not have their own custom dental oral appliance (various brands, commonly Herbst/Somnomed) will be provided with a device (BluePro, BlueSom) for the duration of the study.
~Patients will also be administered sham (room air) at 4 L/min via nasal cannula."
15959859|NCT03189173|Drug|Oxygen|Supplemental oxygen will be delivered at 4 L/min via nasal cannula to improve ventilatory control stability.
15959860|NCT03189173|Other|Oral appliance plus oxygen|Both treatments will be administered simultaneously.
15959861|NCT03189173|Other|No treatment|Subjects will not wear an oral appliance, and will be administered sham (room air) at 4 L/min via nasal cannula.
15959862|NCT03189160|Biological|PEG-rhGH low dose|PEG-rhGH Injection 0.1 mg/kg/w by subcutaneous injection for 52 weeks.
15959863|NCT03189160|Biological|PEG-rhGH high dose|PEG-rhGH Injection 0.2 mg/kg/w by subcutaneous injection for 52 weeks.
15959864|NCT03189160|Other|Non-treatment control group|
15959865|NCT03189147|Procedure|Biceps Tenodesis|Surgical procedure that is usually performed for the treatment of labral lesions in patients undergoing arthroscopic rotator cuff repair
15959866|NCT03189147|Procedure|Debridement|Surgical procedure that is usually performed for the treatment of labral lesions in patients undergoing arthroscopic rotator cuff repair
15959867|NCT03189134|Drug|Fluorescite|Dilute fluorescite will be applied to cardiac tissue prior to imaging
15959868|NCT03189134|Device|Cellvizio 100 Series System with Confocal Miniprobes|Microscopy system will image cardiac tissue.
15959869|NCT03189095|Behavioral|WOWii (Workout on Wheels Internet Intervention)|"Participants will self-monitor their exercise on the WOWii website, which has a page to record the type, duration, and intensity of daily exercise bouts.
~Two devices will track participants' exercise, a Polar heart rate monitor (RS300X, Polar®), which will provide data on the day, duration, and intensity (average and maximum) of aerobic activity and an ActiGraph accelerometer (model GT3X), which detects movement in three planes to indicate frequency and intensity of movement throughout the day. Experimental participants will be provided a Polar heart rate monitor to wear during each exercise bout for the entire length of the 6-month study, and exercise data will be collected weekly.
~Physiological outcomes on fitness will be assessed by measuring weight and aerobic capacity in a Cardiopulmonary Lab by a doctoral-trained physical therapist.
~Participants will complete surveys to report on their exercise self-efficacy and perceived barriers."
15959870|NCT03189082|Procedure|Microbotox|Microbotox is the injection of multiple microdroplets of diluted botulinum toxin into the dermis of the lower face
15959871|NCT03189069|Drug|Apixaban|Treatment for NVAF patients
15959872|NCT03189069|Drug|Dabigatran|Treatment for NVAF patients
15959873|NCT03189069|Drug|Rivaroxaban|Treatment for NVAF patients
15959874|NCT03189069|Drug|Warfarin|Treatment for NVAF patients
15959875|NCT03189056|Diagnostic Test|Chagas serology|IFI + ELISA method if no biological confirmation of chagas disease is in our possession
15959876|NCT03189056|Biological|Creatinina|Plasmatic single mesure after consultation 1, to evaluate renal function
15959877|NCT03189056|Procedure|Urodynamic exploration|With a new equipement SmartDyn Albynmedical imported from Spain for the study Single use sterile equipment shipped Control of urine sterility before procedure Informed consent signed If acquired urinary infection after procedure, patient treated free of charge and clinical evolution controlled
15959878|NCT03189043|Device|Antimicrobial Surface|Antimicrobial Surface
15959879|NCT03189030|Biological|pLADD|via IV infusion
15959880|NCT03189017|Drug|ICP-022|The drug product is a white, round, uncoated tablet.
15959881|NCT03189017|Drug|Placebos|The placebo is a white, round, uncoated tablet.
15959882|NCT03189004|Behavioral|Impact of Mobile Phone Technology to Improve Health Nutrition and Population (HNP) Service Utilization in Rural Bangladesh|"Identification and registration of pregnant women and services for them
~Birth notification
~Childhood vaccination services under EPI
~Newly married couple identification
~e-Referral.
~e-monitoring"
15959883|NCT03188991|Drug|NanoPac®|NanoPac® (Sterile Nanoparticulate Paclitaxel) for intracystic injection via endoscopic ultrasound-guided injection (EUS-FNI)
15959884|NCT03188978|Drug|Atorvastatin 40mg|one 40mg tablet daily for 8 weeks starting 2 weeks before the AVF creation.
15959885|NCT03188978|Other|Placebo|one tablet daily for 8 weeks starting 2 weeks before the AVF creation.
15959887|NCT03188952|Diagnostic Test|International Caries Classification and Management System|Caries assessment and management system
15959888|NCT03188939|Procedure|single injection supraclavicular brachial pleuxus block|the investigator will prepare 20 gauge 10cm block needle and portable ultrasound machine , In single-injection technique using in plane method and lateral to medial direction, local anesthetic is injected at the point where the subclavian artery meets the first rib.
15959889|NCT03188939|Procedure|intracluster injection supraclavicular brachial pieuxus block|the investigator will prepare 20 gauge 10cm block needle and portable ultrasound machine (Siemens ACUSON X300 Ultrasound System with linear probe 8-14 MHZ).using in plane method and lateral to medial direction , the local anesthetic(30 ml bupivacaine) is injected inside main and satellite neural cluster.( Circumferential administration of local anesthetic rather than creating a single point injection )
15959890|NCT03188939|Procedure|double injection supraclavicular brachial pleuxus block|the investigator will prepare 20 gauge 10cm block needle and portable ultrasound machine (Siemens ACUSON X300 Ultrasound System with linear probe 8-14 MHZ).using in plane method and lateral to medial direction , half the volume of local anesthetic(15 ml bupivacaine) is injected at intersection of first rib and subclavian artery and another half(15 ml bupivacaine) is injected supero- lateral to subclavian artery to assure spread of the local anesthetic solution in all planes containing brachial plexus
15959891|NCT03188926|Procedure|intramedullary fixation or endoprosthetic reconstruction|Surgical treatment of impending or pathologic fracture in the extremities
15959892|NCT03188913|Diagnostic Test|Coagulation tests|The following plasma values will be measured: prothrombin time, activated partial thromboplastin time, thrombin time, functional fibrinogen, lactate, base excess, fibrin monomers, Factor XIII, Factor XII, Factor VIII, Fact von Willebrand, Plasmin, Plasminogen, Alpha-2-antiplasmin, antithrombin, protein C, Heparan sulfate, synecan 1. Surveys on the state of healing and moisture titration will be performed using Tewamether
15959893|NCT03188900|Biological|A collection of maternal plasma and serum|A collection of maternal plasma and serum from patients with preeclampsia (PE) and normal pregnancy (NP)
15959894|NCT03188887|Drug|corticotherapy|3 IV pulses steroids followed by oral steroids for 4 months
15959895|NCT03188887|Drug|Renin Angiotensin system (RAS) blockade|treatment with Renin angiotensin system (RAS) blockade
15959896|NCT03188848|Drug|BPI-3016|Single-dose subcutaneous injection of BPI-3016
15959897|NCT03188848|Drug|Placebo|Single-dose subcutaneous injection of placebo to match BPI-3016
15959898|NCT03188835|Dietary Supplement|Diet|A 2 weeks of hypercaloric diet supplemented with fructose or glucose
15959899|NCT03188835|Other|cold exposure|Acute cold exposure using a water-conditioned cooling suit will be applied from time 0 to 180 min. At the same time mean skin temperature will be measured by 11 thermocouples.
15959900|NCT03188835|Radiation|18FDG|I.v. injection of 18-fluorodeoxyglucose (18FDG) will be performed, followed by 30 min dynamic and 50 min wholebody PET/CT scanning.
15959901|NCT03188835|Radiation|11C-acetate|i.v. injection of 11C-acetate will be performed, followed by 20 min dynamic PET/CT scanning
15959902|NCT03188835|Radiation|[3-3H]-glucose|i.v. administration of 1.5 uCi/min of [3-3H]-glucose
15959903|NCT03188835|Other|[U-13C]-palmitate|i.v. administration of 0.08 umol/kg/min of [U-13C]-palmitate
15959904|NCT03188835|Other|2H-Glycerol|i.v. administration of 0.05 µmol/kg/min of 2H-glycerol
15959905|NCT03188835|Device|MRI/MRS|Visceral and cervico-thoracic MRI and MRS acquisition.
15959906|NCT03188835|Device|Electromyogram (EMG)|Skeletal muscle activity and shivering intensity will be measured by electromyography using surface electrodes
15959907|NCT03188835|Device|DXA|Lean mass will be determined by dual-energy X-ray absorptiometry
15959908|NCT03188835|Device|Indirect calorimetry|VCO2 will be measured by indirect calorimetry between 15 and 20 min every hour until time 180.
15959909|NCT03188822|Device|Bioabsorbable steroid releasing sinus implant|After completion of indicated frontal sinus surgery, patients will have a bioabsorbable steroid releasing implant placed in the frontal sinus opening, which will remain in place for 14 days.
15959910|NCT03188822|Device|Bioabsorbable nasal dressing impregnated with steroid|After completion of indicated frontal sinus surgery, patients will have a bioabsorbable nasal dressing impregnated with steroid placed in the frontal sinus opening, which will remain in place for 14 days.
15959946|NCT03188523|Drug|MK-8504|After at least an 8-hour fast, a single oral dose of MK-8504 will be administered in capsule form.
15959947|NCT03188510|Biological|LY3074828|Administered SC
15959948|NCT03188497|Drug|Lobaplatin|Lobaplatin for Injection
15959949|NCT03188497|Device|linear accelerator|Medical linear accelerator
15959950|NCT03188471|Drug|GnRH antagonist|GnRH antagonist 0.25mg daily from the day of oocyte retrieval for seven days for high risk of ovarian hyper stimulation syndrome patients
15959951|NCT03188471|Drug|aspirin|aspirin (100 mg daily, plus saline as placebo of GnRH antagonist ) for seven days
15960406|NCT03185065|Drug|Methylphenidate|5 mg of methylphenidate uptitrated to max of 20 mg of methylphenidate, if tolerated
15959911|NCT03188809|Procedure|Adductor Canal Block|Adductor channel is roughly triangular in cross section and is bounded by three muscles: quadriceps anterolaterally (specifically vastusmedialis), sartorius medially and adductor magnus posteriorly. Within this canal is the femoral artery, femoral vein, the posterior branch of the obturator nerve, and branches of the femoral nerve; specifically the saphenous nerve and nerve to vastus medialis. When the femoral artery is shown by ultrasonography 21 gauge, 50 mm needle in-plane technique and the catheter will be inserted with the peripheral nerve stimulator lateral to the femoral artery. Bupivacaine 0.25% will be applied to the catheter at 6 hours, when the first dose of catheter is inserted.and the catheter will be inserted with the peripheral nerve stimulator lateral to the femoral artery. Bupivacaine 0.25% will be applied to the catheter at 6 hours, when the first dose of catheter is inserted.
15959912|NCT03188809|Procedure|femoral nerve block|The probe is placed just below the inguinal crease , when the femoral artery is shown by ultrasonography, the femoral nerve stays in the lateral direction and 21 gauge, 50 mm needle will be advanced from the anterior to the posteriomedial with an in-plane technique and the catheter will be inserted by the peripheral nerve stimulator in the lateral femoral artery. Bupivacaine 0.25% will be applied to the catheter at 6 hours, when the first dose of catheter is inserted.
15959913|NCT03188796|Drug|Cholecalciferol|oral/enteral loading dose of 37.5 ml MCT including 540,000 IU vitamin D3 followed by 10 drops daily (4000 IU) for 90 days
15959914|NCT03188796|Drug|Placebo|oral/enteral loading dose of 37.5 ml MCT followed by 10 drops daily for 90 days
15959915|NCT03188783|Drug|GDC-0853|GDC-0853 tablets orally, either a single dose or twice-daily.
15959916|NCT03188783|Drug|Placebo|GDC-0853 matching placebo tablets orally, either a single dose or twice-daily.
15959917|NCT03188757|Other|hyperglycaemic clamp|2h hyperglyceamic clamp
15959918|NCT03188744|Other|Assessment of the pelvic floor function|Vaginal palpation and perineometry.
15959919|NCT03188744|Other|Questionnaire application|Questionnaires: EORTC, WHOQoL-BREF, PFID-20; PSIQ-12 and PFIQ-7.
15959920|NCT03188718|Device|WatchPAT Intervention|Wearing the device during their clinically indicated sleep study. This is a validation study to the gold-standard polysomnogram.
15959921|NCT03188705|Drug|Clopidogrel|Participants will receive 300 mg of clopidogrel on the first day, then 75 mg per day for the next 6 days. Measures of pharmacodynamics will be assessed pre- and post-drug administration.
15959922|NCT03188705|Drug|Aspirin|Participants will receive a single dose of 324 mg aspirin on the last day of clopidogrel administration.
15959923|NCT03188692|Biological|DPT-IPV-Hib (Combined Vaccine)|0.5mL, intramuscular injection, 3 times with the 3-8weeks intervals then an additional injection after 6-13 months.
15959924|NCT03188679|Device|amniocentesis|mRNA sequencing on amniotic fluid samples of fetuses after maternal seroconversion for CMV
15959925|NCT03188666|Drug|REGN2477|Pharmaceutical form: liquid product for injection/infusion; Route of administration: Intravenous (IV); Administered during treatment periods 1 and 2.
15959926|NCT03188666|Drug|Matching placebo|Pharmaceutical form: Liquid product for injection/infusion; Route of administration: Intravenous (IV); Administered during treatment period 1 only.
15959927|NCT03188653|Other|CeraVe® Eczema Soothing Body Wash|One of the 7 arm locations will be selected to receive CeraVe® Eczema Soothing Body Wash
15959928|NCT03188653|Other|Cetaphil® RestoraDerm® Eczema Calming Body Wash|One of the 7 arm locations will be selected to receive Cetaphil® RestoraDerm® Eczema Calming Body Wash
15959929|NCT03188653|Other|Dove® Sensitive Skin Body Wash|One of the 7 arm locations will be selected to receive Dove® Sensitive Skin Body Wash
15959930|NCT03188653|Other|Eucerin® Skin Calming Body Wash|One of the 7 arm locations will be selected to receive Eucerin® Skin Calming Body Wash
15959931|NCT03188653|Other|Aveeno® Skin Relief Body Wash|One of the 7 arm locations will be selected to receive Aveeno® Skin Relief Body Wash
15959932|NCT03188653|Other|MooGoo® Milk Wash|One of the 7 arm locations will be selected to receive MooGoo® Milk Wash
15959933|NCT03188653|Other|Free & Clear Liquid Cleanser|One of the 7 arm locations will be selected to receive Free & Clear Liquid Cleanser
15959934|NCT03188640|Procedure|Laparoscopic gastric-bypass surgery|Female participants with BMI >30, between age 18-50, will be operated with laparoscopic gastric bypass surgery by an experienced gastric bypass surgeon.
15959935|NCT03188627|Biological|Bronchial basal cells|Transplantation of autologous bronchial basal cells
15959936|NCT03188614|Drug|Fluid resuscitation|The placebo group is resuscitated with normal saline, the experimental group is resuscitated with balanced fluid.
15959937|NCT03188575|Behavioral|SilverCloud Internet-delivered Cognitive Behavioural Therapy|SilverCloud Health is a leading provider of online therapeutic solutions to support and promote positive behavior change and mental wellness. SilverCloud delivers interventions for all of the anxiety disorders (panic disorder, social anxiety, phobias, GAD, health anxiety, OCD), depression and also comorbid depression and anxiety. The programs for the treatment of depression and anxiety employ several innovative engagement strategies for improving the user experience. These are divided into several categories: personal, interactive, supportive, and social. Research on the SilverCloud interventions has yielded significant clinical outcomes (Richards et al., 2015).
15959938|NCT03188575|Other|Waiting List|8 week waiting list period.
15959939|NCT03188562|Other|PET/CT|Positron Emission Tomography (PET/CT)
15959940|NCT03188562|Procedure|EBUS-TBNA, EUS-NA|Transbronchial and Transesophageal endoscopic ultrasound-guided needle aspiration ( EBUS-TBNA, EUS-NA) Transbronchial ultrasound examination allow to access upper and lower right paratracheal nodes (2R, 4R), subcarinal (7), hilar and interlobar (10, 11), transesophageal ultrasound examination allow to visualize upper and lower left paratracheal nodes (2L, 4L), subaortic (5), para-aortic (6), subcarinal (7), paraesophageal (8), pulmonary ligament (9) nodes. Furthermore EUS allow to localize mediastinal structures including heart, big vessels, main bronchi, vertebral column and diaphragm and can be used in for visualization of tumor infiltration of surrounding structures especially aorta, pulmonary artery or left atrium.
15959941|NCT03188562|Procedure|TEMLA|Transcervical Extended Mediastinal Lymphadenectomy (TEMLA) Transcervical Extended Mediastinal Lymphadenectomy (TEMLA) is minimally invasive surgical technique enabling extensive bilateral lymphadenectomy. The procedure starts from 5-8 cm collar incision in the neck, sternum is elevated with a hook connected to a Rochard frame, both laryngeal recurrent nerves and vagus nerves are visualized. During TEMLA all mediastinal nodal stations except for the pulmonary ligament nodes (9) are removed.
15959952|NCT03188458|Other|Blood sample|Blood samples will be collected from infants prior to their first routine primary pertussis vaccination (At Visit 2 [approximately 4-8 weeks of age]).
15959953|NCT03188445|Drug|Iron Isomaltoside 1000|Administered iv
15959954|NCT03188445|Drug|ferrous fumarate with ascorbic acid|Oral administration
15959955|NCT03188432|Drug|Carboplatin|Given IV and IP
15959956|NCT03188432|Other|Quality-of-Life Assessment|Ancillary studies
15959957|NCT03188432|Other|Questionnaire Administration|Ancillary studies
15959958|NCT03188432|Procedure|Cytoreductive Surgery|Undergo CRS
15959959|NCT03188393|Procedure|Biopsy of Breast|Undergo stereotactic biopsy
15959960|NCT03188380|Diagnostic Test|Plain abdominal radiography|After meeting enrolment criteria each patient will have an AR performed. One image will be obtained with a vertical beam and a horizontal beam, with the patient supine.
15959961|NCT03188380|Diagnostic Test|Abdominal ultrasound|If the AR is inconclusive or no abnormalities typical for NEC are recorded, an AUS will be ordered.
15959962|NCT03188367|Diagnostic Test|Gluten or placebo capsules|Administration of gluten or placebo capsules
15959963|NCT03188354|Diagnostic Test|18F-FDG|PET scan with 18F-FDG as a tracer, taken both for primary staging and therapy assessment.
15959964|NCT03188354|Diagnostic Test|18F-fluciclovine|PET scan with 18F-fluciclovine as a tracer, taken both for primary staging and response to therapy assessment.
15959965|NCT03188354|Diagnostic Test|standard MRI|clinical routine MRI examination, both for primary staging and response to therapy assessment.
15959966|NCT03188341|Other|vascular surgery procedure|"an elective open vascular surgery procedure
~ECG Holter recording during the procedure and 24 hours after operation (continuous electrocardiographic tracing (digital Holter ECG monitor)"
15959967|NCT03188328|Drug|AvidinOX|"AvidinOX vial containing 22.5 mg AvidinOX
~+ vials containing 10 ml of water for injection (WFI) for the reconstitution in a clear solution with an AvidinOX concentration of 3 mg/ml. One Intralesion administration of a volume of reconstituted AvidinOX equal to about 15 % of the estimated lesion volume"
15959968|NCT03188328|Drug|177Lu-ST2210|177Lu-ST2210 dose starting at 7.5 Gigabequerel (GBq) ±10%with escalation steps of 2.5 GBq up to 15 GBq ±10%, approximately 1 mg ST2210
15959969|NCT03188328|Drug|177Lu-ST2210|Second dose of 177Lu-ST2210 dose (14 days after the first dose) starting at 7.5 Gigabequerel (GBq) ±10%with escalation steps of 2.5 GBq up to 15 GBq ±10%, approximately 1 mg ST2210
15959970|NCT03188315|Genetic|HPV oncogenes|PCR and oncogenes detection
15959971|NCT03188302|Other|Collection of stool samples|The subjects collect stool samples to be used for validation of a new direct measurement of stool consistency. Every stool sample produced during 2 collection periods of approximately 60 hours each have to be collected using the Commode Specimen Collection System (Medline Industries, Inc.). Each collection period starts preferably in the evening (20h00) and ends 3 days later in the morning (08h00). The collected samples must be stored at subject's home in a refrigerator provided by the sponsor until handover to the site staff.
15959972|NCT03188289|Drug|Placebo gel|Placebo is the control group treated with a placebo gel.
15959973|NCT03188289|Drug|Clorhexidine gel|Clorhexidine will be compare with placebo, clorhexidine-chitosán and hyaluronic acid bioadhesive gels
15959974|NCT03188289|Drug|Clorhexidine-Chitosan gel|Clorhexidine-chitosan will be compare with placebo, clorhexidine and hyaluronic acid bioadhesive gels.
15959975|NCT03188289|Drug|Hyaluronic Acid gel|Hyaluronic acid will be compare with placebo, clorhexidine, clorhexidine-chitosan bioadhesive gels
15959976|NCT03188276|Drug|Ledipasvir-Sofosbuvir|15 CHC patients were treated with Sofosbuvir (400mg, qd)/Ledipasvir (90mg, qd) for 12 weeks
15959977|NCT03188276|Drug|Daclatasvir-Sofosbuvir|17 CHC patients were treated with Sofosbuvir (400mg, qd)/Daclatasvir (60mg,qd) for 12 weeks.
15959978|NCT03188263|Other|Bright Light|1 hour daily morning light treatment provided through a head-worn device for 4 weeks with the following settings: irradiance is 230 μW/m2 and lux is 500 lux.
15959979|NCT03188263|Other|Dim Light|1 hour daily morning light treatment provided through a head-worn device for 4 weeks with the following settings: irradiance in this dimmed is reduced from 230 μW/m2 to 3 μW/m2, and lux reduced from 500 lux to 7 lux
15959980|NCT03188250|Behavioral|Chama cha Mamtoto|Chama cha Mamatoto is a community-based model of peer support group in pregnancy and infancy that combines health education, relationship building and a savings and loans program, led by community health workers
15959981|NCT03188237|Behavioral|AfyaJamii|AfyaJamii is a group antenatal and well-child care program developed in Kenya for use in Kenyan health centers
15959982|NCT03188224|Other|MyTransition app|MyTransition app is designed to support youth moving from pediatric to adult healthcare.
15959983|NCT03188211|Other|E-learning educational program|A number of 10 cases of patients 65 years of age or older with AF, acutely admitted to Internal Medicine or Geriatric wards for any medical condition, will be edited into the Dr. Sim system. Diagnostic and therapeutic choices for ordinary and/or complex medical situations will be taken through the development of the simulated scenario.
15959984|NCT03188211|Other|Control|Any educational program will be delivered to clinicians assigned to control arm
15959985|NCT03188198|Drug|rituximab, etoposide, cyclophosphamide, doxorubicin, vincristine,prednisone, filgrastim|
15959986|NCT03188185|Drug|ALKS 5461|Samidorphan + buprenorphine, administered sublingually
15959987|NCT03188185|Drug|ALKS 5461 Placebo|Placebo tablet, administered sublingually
15959988|NCT03188172|Drug|Cyclophosphamide|Chemotherapy
15959989|NCT03188172|Drug|Bortezomib|Chemotherapy
15959990|NCT03188172|Drug|Lenalidomide|Chemotherapy
15959991|NCT03188172|Drug|Daratumumab|Chemotherapy
15959992|NCT03188172|Drug|Dexamethasone|Chemotherapy
15959993|NCT03188172|Drug|Melphalan|Chemotherapy
15959994|NCT03188172|Drug|Filgrastim|Haematopoietic agent for the stem cell harvest
15959995|NCT03188159|Drug|Vinorelbine|Vinorelbine 25 mg/m2 intravenously on day-1 and day-8 of a 3 week cycle to commence following confirmation of eligibility into the study for a maximum of 12 months, until disease progression, intolerable toxicity or withdrawal of patient consent (whichever event occurs first).
15959996|NCT03188146|Drug|Ursodeoxycholic Acid|Standard care of PBC patients
15959997|NCT03188133|Other|behavioral task : emotional priming|emotional priming task on ambiguous visual stimuli
15959998|NCT03188120|Drug|Spiriva Respimat|Drug
15959999|NCT03188107|Other|Video based assessment|All the infants included in this study will be assessed with Infant Motor Profile based on video recording.
15960000|NCT03188094|Other|community health worker (CHW)-led health coaching for patients|Using a stepped-wedge design, investigators will implement the study in 25 NYC PCP sites enrolling 2,840 South Asian patients at- risk for T2DM.
15960001|NCT03188081|Drug|Abatacept|Subcutaneous
15960002|NCT03188068|Drug|Sirolimus|Oral administration
15960003|NCT03188068|Drug|Prednisolone|Oral administered with sirolimus
15960004|NCT03188055|Other|Best Case/Worst Case communication tool|"The communication tool promotes dialogue and patient deliberation, and supports shared decision making in the context of life-limiting illness. Building on a conceptual model of shared decision-making proposed and the practice of scenario planning our intervention is designed to lead to a discussion of patient preferences and consideration of outcomes.
~The surgeon verbally describes the best case, worst case, and most likely outcomes for each treatment option-incorporating rich narrative from clinical experience and translation of probabilistic information-while drawing a diagram of those options. The surgeon also writes details about each option on the diagram. The narrative and graphic help family and patients formulate and express preferences."
15960005|NCT03188042|Device|rtACS Stimulation|Electric current stimulation; rtACS is a non-invasive application of electric current to stimulate the retina to induce synaptic efficacy, in particular those cells that have some measure of dysfunction but are not dead, and oscillations of nearby neuronal ensembles.
15960006|NCT03188042|Device|Sham Intervention|A computer-controlled sham stimulation function for masking interventionist to study group. The device will be used to deliver a weak electric current stimulation protocol to participants via electrodes placed transorbitally, with one reference electrode positioned elsewhere.
15960007|NCT03188029|Diagnostic Test|adrenocortical function|"Blood samples for cortisol dosage are performed and 24 hours after the sixth session. All blood samples are performed at 9 and collected in normal tube.
~Blood samples for glycaemia, sodium, potassium and bicarbonates are performed at the same rate."
15960008|NCT03188016|Behavioral|Intensive Interaction with Music|Intensive Interaction is a form of non-verbal communicative behaviour performed by a support worker to encourage and develop spontaneous communicative behaviour by the treatment subject, for which support workers are prepared by a speech and language therapist. The music in the intervention is live music improvised by a (UK) registered music therapist present in the room with treatment subject and support worker, who watches but does not participate socially in their interactions, and who develops musical input to encourage and enhance those interactions.
15960009|NCT03188016|Behavioral|Standard Intensive Interaction|Intensive Interaction is a form of non-verbal communicative behaviour performed by a support worker to encourage and develop spontaneous communicative behaviour by the treatment subject, for which support workers are prepared by a speech and language therapist.
15960010|NCT03188003|Other|Exercise Movement Techniques based on mobilization|10 sessions will be held twice a week, with each session taking an average of 50 minutes.
15960011|NCT03188003|Other|Exercise Movement Techniques based on stabilization|10 sessions will be held twice a week, with each session taking an average of 50 minutes.
15960012|NCT03187990|Drug|[68Ga]PSMA-11|PET/MRI with [68Ga]PSMA will be compared to mpMRI for biopsy guidance.
15960013|NCT03187990|Drug|[18F]PSMA-1007|18F-PSMA-1007 PET/CT for biopsy guidance and intraoperative target verification.
15960014|NCT03187977|Behavioral|Cognitive training|Cogmed is a computer-based cognitive training program that consists of rotating exercises that train attention and working memory. The exercises are presented in a child-friendly, game-like format. The program is completed at home for 15-45 minutes each weekday for 5-9 weeks.
15960015|NCT03187964|Diagnostic Test|PLHIV Point of Care Xpert Ultra|Sputum-based TB diagnostic test that takes 80 min to run. Test performed on the same day as the patient visit.
15960016|NCT03187964|Diagnostic Test|PLHIV Point of Care Xpert VL|Blood-based HIV-1 VL diagnostic and monitoring test that takes 60 min to run. Test performed on the same day as the patient visit.
15960017|NCT03187951|Behavioral|Questionnaires|Participants complete 4 questionnaires about physical abilities, motivation, and quality of life They should take about 25 minutes total to complete.
15960018|NCT03187951|Behavioral|Nutritional Questionnaire and Nutritional Counseling|Participants complete a nutritional questionnaire and receive nutritional counseling. It should take about 5 minutes to complete. Participants receive educational materials and personalized counseling based on participant's answers.
15960019|NCT03187951|Other|Booklet|Participants receive a booklet that contains a stretching guide with full-body stretches and safety.
15960020|NCT03187951|Behavioral|Aerobic Exercise and Strength Training Exercises|Participants complete up to 30 minutes of moderate-intensity aerobic exercise (such as brisk walking, stationary cycling, and/or elliptical or stair stepping machines) for at least 5 days each week. Participants complete strength training exercises at least 2 times per week.
15960021|NCT03187951|Behavioral|Phone Calls|Participants contacted by phone by member of study staff one (1) time each week for the first 4 weeks, and then every 2 weeks after that for behavioral skills training and to see how participant is doing. These calls should last about 15 minutes.
15960022|NCT03187951|Behavioral|Physical Assessments|After completion of chemotherapy and/or radiation, 3-6 weeks after surgery, and then 3-7 months after surgery: Participant's hand grip strength measured using a hand-held machine. Participants arm strength measured using an arm curl test. Participants asked to rise from a chair without using their arms to push off. Participants complete a 6-minute walk test to see how far participant can walk in 6 minutes.
15960023|NCT03187938|Diagnostic Test|Testing of Alkaline Phosphatase Levels|Testing of alkaline phosphatase levels at the time of the 24w0d to 28w6d week labs.
15960024|NCT03187925|Procedure|open, transcervical versus rigid endoscopic treatment|The goal of the project is to perform the first prospective, multi-institutional long-term (5 year) study comparing the outcomes of open, transcervical versus rigid endoscopic treatment of cervical esophageal diverticulum and cricopharyngeal dysfunction in resolving associated symptoms, complications, and recurrence rates of dysphagia surgery. This study will also include cricopharyngeal bar as it pertains to an early Zenker's diverticulum.
15960025|NCT03187912|Drug|Riboflavin|Riboflavin with 20% Dextran or HPMC will be admininstered every 2 minutes for overall 30 minuts (Dextran) or 10 minutes (HPMC), respectively
15960083|NCT03187457|Other|Control: no treatment|Healthy women without Bacterial Vaginosis
15960026|NCT03187899|Drug|Ropivacaine|0.5% of Ropivacaine will be used patients in both groups. Ropivacaine is very common in the investigator's practice of regional anesthesia. The investigator has experienced minimal adverse effects with 0.5% Ropivacaine used in volume suggested in our study.
15960027|NCT03187899|Drug|Normal saline|5-10cc of Normal Saline will be given to patients receiving a traditional interscalene block and a sham superficial plexus block.
15960028|NCT03187873|Behavioral|Chama cha MamaToto|Chamas are a community-led model of peer support for women in pregnancy and infancy. Chamas are highly gendered institutions that women have relied on for survival to pool resources. Using this existing cultural script, chamas have been tailored to the needs of pregnant women. Central to the approach is the integration of health, social and financial literacy education with a savings/loans program. Chamas are designed to improve MNCH by generating positive peer support for women to advocate for themselves and account for the care they receive.
15960029|NCT03187860|Procedure|Bronchial Biopsy|Bronchial biopsies will be performed on all subjects.
15960030|NCT03187860|Other|ALI culture|Air-liquid-interface cell cultures will be derived from bronchial biopsy specimens. We are expecting several replicate cell lines from each biopsy specimen.
15960031|NCT03187847|Device|Actigraph GT3X|"The primary outcomes are measured by the Actigraph GT3X (step counts) and FSMC (fatigue scale for motor and cognitive functions questionnaire) at three different points in time (Actigraph is worn for three weeks in total).
~The secondary outcomes are emotional status, measured by the hospital anxiety and depression scale (HADS) and quality of life, measured by the Hamburg Quality of Life Questionnaire in MS (HAQUAMS)."
15960032|NCT03187834|Drug|Azithromycin|Children in this arm will receive Azithromycin once a day.
15960033|NCT03187834|Drug|Amoxicillin|Children in this arm will receive Amoxicillin twice a day.
15960034|NCT03187834|Drug|Cotrimoxazole|Children in this arm will receive co-trimoxazole once a day.
15960035|NCT03187834|Drug|Placebo|Children in this arm will receive Placebo once a day.
15960036|NCT03187821|Procedure|Laser peripheral iridotomy|location of laser peripheral iridotomy
15960037|NCT03187808|Other|Single thoracic manipulation|The subjects, who were randomly allocated to single thoracic manipulation group, will receive the single thoracic manipulation interventions directly to both sides of zygapophyseal joints of T6-T7. Each subject will be asked to lie on prone position on an experimental table. After that, the researcher will mark on both sides of zygapophyseal joints of T6-T7. Then, the subject will be instructed to take a deep inhalation and exhalation. During the exhalation, the therapist will perform the single thoracic manipulation (screw thrust technique) at zygapophyseal joints of T6-T7. If the audio pop is not heard during the first attempt, the therapist will ask the subject to reposition and repeat the technique. The procedure will be performed for maximum of 2 attempts and within 2 minutes.
15960038|NCT03187808|Other|Special massage technique (RT technique)|The special massage technique or RT technique is a treatment that was developed by Puntumetakul and colleagues in 2013 (copyright registration number 314783). The subjects in this group will be asked to lie on side lying position with 90 degrees of hip flexion and 90 degrees of knee flexion. The researcher will perform the RT technique by press their thumb on the treatment lines beside the posterior vertebral line from level of inferior angle of scapula to the lowest rib for 5 seconds per point and 3 sets per treatment line (Figure 8). Total time of this procedure is approximately 2 minutes.
15960039|NCT03187795|Drug|Oxybutynin Chloride IR|Oxybutynin chloride immediate release (IR) 5 mg three times daily for 6 weeks
15960040|NCT03187795|Drug|Mirabegron|Mirabegron 25 mg tablet once daily for 2 weeks, followed by mirabegron 50 mg once daily for 4 weeks (Note: Placebo twice daily will be included with mirabegron once daily to match the three-time daily dosing of oxybutynin IR in the other intervention).
15960041|NCT03187782|Diagnostic Test|ANSWatch|
15960042|NCT03187769|Drug|ALKS 3831|Olanzapine + samidorphan, daily oral dosing
15960043|NCT03187769|Drug|Olanzapine|Daily oral dosing
15960044|NCT03187756|Drug|Cyclophosphamide|Shortened duration immunosuppression following nonmyeloablative peripheral blood stem cell transplant with high dose post transplantation cyclophosphamide in malignancies to engraft.
15960045|NCT03187743|Other|Blood samples|"Blood samples at 3 visits :
~V0 : - 5 mL in heparin tube / Pharmacokinetics + Gene Expression Analysis
~V1 : - 5 mL in heparin tube / sample (2 to 5 samples) Pharmacokinetics + Pharmacogenetics + Gene Expression Analysis
~V2 : - 5 mL in heparin tube / Pharmacokinetics + Gene Expression Analysis and - 5 mL in EDTA tube / DNA bank"
15960046|NCT03187730|Behavioral|Integrated Smoking Cessation and Financial Counseling|Participants in the intervention group will receive up to nine counseling sessions that integrate two evidence-based counseling approaches: financial management counseling and smoking cessation counseling. Participants will also be eligible to receive a free four-week supply of NRT. Participants will be surveyed at baseline, 2- months, 6-months and 12-months to assess outcomes and treatment satisfaction.
15960047|NCT03187730|Behavioral|Waitlist Integrated Smoking Cessation and Financial Counseling|Control participants in the waitlist control group will receive usual care for the first 6 months of the study, while the Intervention Arm receives integrated counseling. The waitlist control group will receive the same counseling program as the Intervention group 6 months after enrollment (up to nine counseling sessions and four weeks of NRT). Participants will be surveyed at baseline, 2-months, 6-months and 12-months to assess outcomes and treatment satisfaction.
15960048|NCT03187730|Drug|Nicotine Replacement Therapy (NRT)|Participants in both arms will be eligible to receive a free four-week supply of NRT.
15960049|NCT03187704|Other|HEPA air filtration|Air filters were placed in participant homes
15960050|NCT03187691|Drug|Oral Encochleated Amphotericin B (CAMB)|Lipid-crystal nano-particle formulation amphotericin B
15960051|NCT03187678|Drug|i.v. selexipag|Selexipag for intravenous administration, twice daily as an infusion over 87 min. The dose is individualized for each subject to correspond to his/her current oral dose of Uptravi®.
15960052|NCT03187678|Drug|oral selexipag (Uptravi)|Uptravi is used as an auxiliary medicinal product, as part of the PAH standard treatment and administered according to the local prescribing information
15960084|NCT03187444|Procedure|Examinations|Several examinations are realized on each patients, in addition to the usual visit and after verification of the criteria of inclusion and signature of consent.
15960085|NCT03187431|Biological|autologous bone marrow mesenchymal stem cells|intravenous infusion
15960407|NCT03185065|Drug|Placebos|1 placebo capsule increased to max of 2 capsules twice daily
15960053|NCT03187665|Device|Radical 7|The Radical 7 is the traditional wall-connected pulse oximeter currently used at Children's Hospital of Wisconsin (CHW) which requires a 12 foot cable connecting the patient to a wall unit. While being continuously monitored with the Radical 7 pulse oximeter, subjects will be asked to complete age appropriate activities. The pulse oximetry data will be analyzed for instances of alarm state corresponding to loss of signal integrity as defined by complete inability to pick up the subject signal or a change in the pulse oximetry saturation value by 4%.
15960054|NCT03187665|Device|Radius 7|The Radius 7 is a newer, partially wireless pulse oximeter which eliminates the cable connecting the patient to a wall unit by instead connecting to a small device worn on the patient's arm or leg. The small device then sends the continuous pulse oximeter data wirelessly to the central monitoring station. While being continuously monitored with the Radius 7 pulse oximeter, subjects will be asked to complete age appropriate activities. The pulse oximetry data will be analyzed for instances of alarm state corresponding to loss of signal integrity as defined by complete inability to pick up the subject signal or a change in the pulse oximetry saturation value by 4%.
15960055|NCT03187652|Diagnostic Test|CT Perfusion Study|Brain and cardiac CT perfusion scan
15960056|NCT03187652|Diagnostic Test|Echocardiogram|Speckle tracking Echocardiography
15960057|NCT03187652|Diagnostic Test|neuro-cognitive assessment|Cambridge Brain Sciences neuro-cognitive assessment
15960058|NCT03187652|Diagnostic Test|MRI|MRI to assess white matter changes
15960059|NCT03187639|Diagnostic Test|FFRct|In the test group all patients who are eligible for CTA will undergo CTA as their default test. Those patients with any coronary stenosis of equal or > 40% data in at least one major epicardial vessel of stentable/graftable diameter will be referred for FFRct. (NB Lesions in distal vessels or vessels of a diameter not suitable for stenting/grafting will not qualify for FFRct if there are no other more significant lesions). In patients in whom FFRct analysis is performed, FFR will be derived for all vessels. The data derived from this test will determine their management strategy. The patients in this arm will not follow the NICE guideline algorithm. Those patients randomised to FFRct with contraindications for CTA will be asked to take part in a trial registry.
15960060|NCT03187639|Diagnostic Test|Standard care|All patients in the standard care group will be assessed according to their current conventional pathways that are based upon NICE guidelines for Chest Pain of Recent Onset. The trial will encourage the routine and standard assessment and management of all patients at these sites… (anticipated outcomes include ETT, stress echo, stress MR, nuclear perfusion, CTA, CT calcium, invasive CA, reassurance), in accordance with the local application of the NICE guideline for chest pain of recent onset.
15960061|NCT03187626|Drug|botulinum toxin A|Ultrasound-guided injection of 50 Allergan Unities of botulinum toxin A (Botox®, Allergan) resuspended in 1 ml of saline in the trapeziometacarpal joint and custom-made thermoformed plastic splint to be worn for 48 hours after intra-articular injection then nightly
15960062|NCT03187626|Drug|saline|Ultrasound-guided injection of 1 ml of saline in the trapeziometacarpal joint and custom-made thermoformed plastic splint to be worn for 48 hours after intra-articular injection then nightly
15960063|NCT03187600|Procedure|Mucosa/submucosa Pharyngeal Flap|Included in study arm description
15960064|NCT03187600|Procedure|Standard of Care Pharyngeal Flap|Included in study arm description
15960065|NCT03187587|Device|imILT|The imILT treatment arm recieves imILT treatment and no simultaneous chemotherapy.
15960066|NCT03187587|Drug|Standard chemotherapy treatment|The standard chemotherapy treamtment arm recieves only chemotherapy.
15960067|NCT03187574|Device|Elevate Ant™|Surgery with Elevate Ant™
15960068|NCT03187574|Device|Perigee™|Surgery with Perigee™
15960069|NCT03187561|Behavioral|Infant sleep-adapted coparenting intervention|The Family Foundations intervention, as originally formulated, and a sleep-adapted Family Foundations intervention, will be implemented to participants in arm 1 and arm 2, respectively.
15960070|NCT03187548|Drug|Casein Phosphopeptide-Amorphous Calcium Phosphate Dental Paste|Application of CPP-ACP on one premolar once every 2 weeks for 3 months.
15960071|NCT03187535|Device|TEAS via ES-130|Transcutaneous Electrical Acupoint Stimulation will be administered delivered by the ES-130 device for 20 minutes at the time ondansetron is given (typically 30 minutes before the end of surgery). Subjects randomized to this intervention will have the TEAS device connected to the previously placed ECG patches to deliver the stimulus.
15960072|NCT03187535|Other|No TEAS|No Transcutaneous Electrical Acupoint Stimulation will be delivered to the subjects randomized to this group; ECG patches will be placed at the identified acupoints, however, no electrical stimulus will be delivered.
15960073|NCT03187522|Device|TREO Stent-Graft System|The TREO® Stent-Graft is designed for use in the management of patients with AAAs and is composed of self-expanding nitinol stents sutured to polyester vascular graft fabric.
15960074|NCT03187509|Drug|Torsemide|These subjects who are randomized to a weight-based torsemide regimen will be instructed via phone encounters three times per week to take an individualized dose of torsemide based on their current weight and symptoms. These subjects will have a follow-up study appointment at week 5 for a final weight and blood work to assess kidney function, electrolytes and brain-natriuretic peptide levels.
15960075|NCT03187509|Other|Standard Outpatient Heart Failure Management|Those subjects randomized to standard outpatient management group will be prescribed a daily fixed dose of a loop diuretic upon discharge from the hospital. These subjects will have a follow-up appointment within one week of discharge where all medications including loop diuretic type, dose and frequency will be managed at the discretion of the subject's physician. These subjects will also have a follow-up study appointment at week 5 for a final weight and blood work to assess kidney function, electrolytes and brain-natriuretic peptide levels.
15960076|NCT03187496|Drug|Midazolam|Each subject will receive midazolam on Days 1 and 12.
15960077|NCT03187496|Drug|Caffeine|Each subject will receive caffeine on Days 1 and 12.
15960078|NCT03187496|Drug|Rosuvastatin|Each subject will receive rosuvastatin on Days 2 and 13.
15960079|NCT03187496|Drug|EDP-305|Each subject will receive EDP-305 on Days 5 through 15.
15960080|NCT03187483|Procedure|orthodontic treatment|orthodontic treatment in maxillary crowding
15960081|NCT03187470|Device|Different programming of a CRT defibrillator|Different programming of a CRT defibrillator using pacing modalities of a quadripolar left ventricular lead
15960082|NCT03187457|Other|Metronidazole|Women with Bacterial Vaginosis treated with Metronidazole for 5 days
15960086|NCT03187418|Device|MicroPulse® P3 Glaucoma Device (MP3)|"Laser settings will be programmed as follows: power-2000mW-2500mW (average 2000mW) of 810nm infrared diode laser set on micropulse delivery mode; micropulse on time-0.5ms; micropulse off time-1.1ms; and duty cycle (proportion of each cycle during which the laser is on)-31.33 %.
~The laser probe will be applied in a continuous sliding or painting motion from 9:30 to 2:30 and from 3:30 to 8:30. The probe will be applied perpendicular to the limbus with the edge directly on the limbus at all times (fiberoptic tip at 3 mm posterior to the limbus).
~The laser will be delivered over 360° for 160-320s. Treatment duration will be adjusted based on iris color and glaucoma severity (mild glaucoma: 160s, moderate glaucoma: 240s, advanced glaucoma: 240-320s)."
15960087|NCT03187405|Drug|EVD + IVF with Alteplase|Intraventricular fibrinolysis: Injection through the EVD of 1mg in 1 mL of Alteplase every eight hours during 3 days (9 doses).
15960088|NCT03187392|Drug|Lidocaine Injectable Product|3 cm of Lidocaine- will be injected subcutaneous for 5 minutes before insertion of subcutaneous birth control implant
15960089|NCT03187392|Drug|Lidocaine Topical Cream [LMX]|3 mg of Lidocaine- will be applied to skin for 5 minutes before insertion of subcutaneous birth control implant
15960090|NCT03187379|Drug|Exparel|Exparel liposomal bupivacaine - 20cc Exparel® + 60cc Bupivicaine
15960091|NCT03187379|Drug|Bupivacaine|60cc Bupivacaine
15960092|NCT03187366|Other|Bottom-up intervention|Some interventions are bottom-up, where we manipulate the resources of snails and some are top-down, where we manipulate the predators of snails.
15960093|NCT03187353|Drug|Lisdexamfetamine|Stimulant medications are used to reduce interruptive behavior, fidgeting, and other hyperactive symptoms, as well as help a person finish tasks and improve his or her relationships for adults who have ADHD. Please note that the FDA has not approved the use of Vyvanse® for the treatment of memory and concentration difficulties related to medically induced menopause.
15960094|NCT03187353|Drug|Placebo oral capsule|The placebo capsule will be filled with microcellulose.
15960095|NCT03187340|Behavioral|Sleep education and relaxation 1|Sleep hygiene and relaxation training; Sleep education and relaxation 1
15960096|NCT03187340|Behavioral|Sleep education and relaxation 2|Modified sleep hygiene and relaxation training; Sleep education and relaxation 2
15960097|NCT03187314|Drug|Radiation|RT to 60 Gy, 5 x per week，for 6 weeks. Radiation begun the day after the first dose of SHR-1210
15960098|NCT03187314|Drug|SHR-1210|SHR-1210 (200mg fixed dose every 2 weeks for 5 cycles) will be administered as an intravenous infusion over 60 minutes.
15960099|NCT03187301|Drug|APL-130277|APL-130277 single dose
15960100|NCT03187301|Drug|Placebo|Placebo single dose
15960101|NCT03187301|Drug|Moxifloxacin|moxifloxacin 400mg single dose
15960102|NCT03187288|Drug|CFI-400945 Fumarate|CFI-400945 is an investigational drug that is being look at for the treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). CFI-400945 is an oral (taken by mouth) drug that blocks Polo-like kinase 4 (PLK4) activity. PLK4 is a protein that is important in regulating cell growth and division and cell death. Many tumors are shown to make too much PLK4. When there is too much PLK4 produced, it is believed to contribute to uncontrolled cancer cell growth and division. Therefore, by blocking this protein from working, it is believed to stop tumors from growing or shrink them.
15960103|NCT03187275|Other|Swedish Massage Therapy|"The therapist uses non-aromatic massage oil to facilitate making long, smooth strokes over the body. Swedish massage is done with the subject covered by a sheet, a technique called draping. One part of the body is uncovered, massaged, and then covered up before moving onto another part of the body. Primary techniques used in the research protocol therapy are: effleurage, petrissage, tapotement. These will be administered according to a very specific, standardized protocol. The total session time will be 45 minutes."
15960104|NCT03187275|Other|Light Touch Intervention|The light-touch research intervention is based on the concept that there will be a noticeable effect with regard to massage when compared to light-touch alone without the massage. The protocol followed will be the same as the massage protocol other than that the therapist will use light-touch only. The total session time will be 45 minutes.
15960105|NCT03187262|Drug|Daratumumab|Daratumumab is a monoclonal human antibody. Daratumumab has shown the ability to slow or stop the growth of cells that have CD38 on the cell surface when tested in laboratories
15960106|NCT03187249|Behavioral|Cognitive Behavioral Therapy|12 weeks cognitive-behavioral lessons, once a week
15960107|NCT03187249|Behavioral|Pulmonary Rehabilitation Therapy|12 weeks pulmonary rehabilitation exercise
15960108|NCT03187249|Behavioral|Combined Therapy|cognitive-behavioral lessons and pulmonary rehabilitation exercise for 12 weeks
15960109|NCT03187223|Drug|Melphalan|High-dose chemotherapy regimen for conditioning treatment before autologous stem cell Transplantation. Patients will receive melphalan at a total dose of 200mg/m2, divided in two doses of 100mg/m2/day on days -2 and -1, with the ASCT at day 0.
15960110|NCT03187223|Drug|Bendamustine|High-dose chemotherapy regimen for conditioning treatment before autologous stem cell Transplantation. Patients will receive bendamustine at a total dose of 400mg/m2, divided in two doses of 200mg/m2/day on days -4 and -3. Melphalan is given at a total dose of 200mg/m2, divided in two doses of 100mg/m2/day, each on days -2 and -1, with the ASCT at day 0.
15960111|NCT03187210|Drug|Brentuximab Vedotin|Brentuximab Vedotin at day -8 together with standard BeEAM chemotherapy at days -7 to -1 followed by ASCT on day 0
15960112|NCT03187210|Drug|BeEAM Regimen|standard BeEAM chemotherapy at days -7 to -1 followed by ASCT on day 0
15960113|NCT03187197|Drug|Pradaxa®|Dabigatran etexilate
15960114|NCT03187184|Device|OneOme RightMed®|OneOme RightMed® currently tests for 22 genes that impact over 340 drugs used in multiple fields of medicine, including oncology. The drugs tested for by OneOme RightMed® were generated from practice guidelines and the FDA's guidelines for genotyping, and drugs with published, clinical evidence supporting genotyping. Testing is done using a prepackaged OneOme RightMed® kit to collect a buccal swab. OneOme RightMed® PGx test uses a DNA Genotek ORAcollect OC-100 buccal swab kit to extract DNA, which is then analyzed through polymerase chain reaction (PCR).
15960162|NCT03186846|Device|placebo|Before the induction, up to 250ml of balanced crystalloid solution will be administered. These will include antibiotics solvents and other pre-induction i.v. therapy.
15960163|NCT03186833|Other|no intervention|no intervention
15960164|NCT03186820|Other|Susceptibility Weighted Imaging as 3D SWAN sequence|Susceptibility Weighted Imaging as 3D SWAN sequence
15960115|NCT03187171|Other|Allograft Fusion|ACDF is a surgical technique used to treat a variety of cervical spine disorders, such as nerve root or spinal cord compression, cervical spondylosis, and cervical spinal stenosis. The anterior approach to the cervical spine for discectomy and fusion by the insertion of an autologous iliac crest tricortical bone graft was first described by Robinson and Smith in 1955. In 1958, Cloward described a wide anterior cylindrical discectomy performed with a special reamer combined with anterior fusion by the insertion of autologous iliac bone graft of the same shape. At Duke University Health Systems, both allografts and Cohere porous PEEK fusion device are used for ACDF.
15960116|NCT03187171|Device|Cohere PEEK Fusion Group|Bagby et al. developed the first interbody fusion cage. Cages of different shapes and materials are used to perform ACDF which, in some cases, could be associated with plate fixation. At Duke University Health Systems, both allografts and Cohere porous PEEK fusion device are used for ACDF.
15960117|NCT03187158|Diagnostic Test|Forced Oscillation Technique|F.O.T. method can be used to assess obstruction in the large and small peripheral airways , Changes in lung volumes will be measured using a digital spirometer . Every participant will be asked to sit straight, seal the mouthpiece completely with their lips, breathe in fully, blow as hard as possible into the mouthpiece, emptying the lungs completely., Whole blood collected on site (20 mL from every participant, for about 23 metabolites) will be separated into cells and serum. A detailed questionnaire assessing respiratory health, demographic data, habits, and environmental exposure has been developed and validated by Chest Research Foundation.
15960118|NCT03187132|Device|Digital Pain Reduction Kit|A two-component intervention consisting of (1) virtual reality, experiences lasting 3-30 minutes used to distract individuals from pain and to teach skills related to chronic pain; (2) TENS unit, used to reduce acute localized pain.
15960119|NCT03187132|Device|Active Control|An active control TENS unit used to reduce acute localized pain.
15960122|NCT03187106|Drug|Cephalexin|Other name(s): Keflex (cephalexin) Cephalexin at 500 mg per oral every 8 hours for a total of 6 doses
15960123|NCT03187106|Drug|Placebo|Placebo representing standard of care
15960124|NCT03187106|Drug|Metronidazole|Other name(s): Flagyl (metronidazole) Metronidazole at 500 mg per oral every 8 hours for a total of 6 doses
15960125|NCT03187093|Drug|Vortioxetine|10-20 mg once daily for 8 weeks
15960126|NCT03187093|Drug|Escitalopram|10-20 mg once daily for 8 weeks
15960127|NCT03187080|Procedure|Paravertebral block procedure using either local anesthetic (0.25% bupivacaine) or sterile saline|Paravertebral block (PVB) will be performed in the standard fashion using an out-of-plane ultrasound approach by an anesthesiologist with appropriate training in regional anesthesia. Landmarks on the patient will be identified. The skin will be sterilized. The intended target (paravertebral space) will be located using an ultrasound. A Pajunk UniPlex NanoLine needle will be inserted. A syringe filled with sterile saline (used for hydrodissection) connected to a syringe of 0.25% bupivacaine with 2.5 mcg/mL of epinephrine will be connected to the Pajunk needle and used for injection. The needle will be advanced toward and through the superior costotransverse ligament or internal intercostal membrane. Once through the ligament, the pleura will be seen deflecting anteriorly with the hydrodissection. Negative aspiration will be confirmed, and the local anesthetic will be injected into the paravertebral space.
15960128|NCT03187080|Other|Enhanced recovery after breast surgery (ERABS) strategies|"For comparing ERABS strategies to our current standard of care, we will utilize the following perioperative strategies [Arsalani]:
~Standardized written information given preoperatively.
~Allow clear liquids for up to 2 hours prior to arrival at the surgery center.
~Use paravertebral block to augment postoperative pain control.
~Standardized multimodal analgesic regimen
~Antiemetics
~Easily accessible call-in or walk-in postop care/support
~The proposed strategies differ from standard of care in the following ways:
~PVB is less commonly used in elective surgery.
~Patients do not eat or drink after midnight.
~There is no standardized preoperative information packet.
~Anesthetic/intraoperative analgesic and antiemetic regimen varies between providers."
15960129|NCT03187080|Procedure|Sham paravertebral block using saline|Paravertebral block (PVB) will be performed in the standard fashion using an out-of-plane ultrasound approach by an anesthesiologist with appropriate training in regional anesthesia. Landmarks on the patient will be identified. The skin will be sterilized. The intended target (paravertebral space) will be located using an ultrasound. A Pajunk UniPlex NanoLine needle will be inserted. A syringe filled with sterile saline (used for hydrodissection) connected to a syringe of sterile saline will be connected to the Pajunk needle and used for injection. The needle will be advanced toward and through the superior costotransverse ligament or internal intercostal membrane. Once through the ligament, the pleura will be seen deflecting anteriorly with the hydrodissection. Negative aspiration will be confirmed, and the local anesthetic will be injected into the paravertebral space.
15960130|NCT03187080|Drug|Paravertebral block using local anesthetic|Use of local anesthetic (0.25% bupivacaine) that is *NOT* an experimental drug but will be used as part of the paravertebral block to provide local anesthetic. This will not be given to those in the sham block groups.
15960131|NCT03187067|Device|Lung ultrasound|Lung ultrasound will be performed on all children to investigate imaging patterns characteristic of pneumonia.
15960132|NCT03187054|Procedure|anterior or posterior colporrhaphy|will be performed in a traditional manner with midline plication of the fibromuscular layer using 2-0 delayed absorbable sutures.
15960161|NCT03186846|Device|multimodal monitoring|LiDCO Rapid, unilateral INVOS and unilateral BIS monitors will be applied. Should there be pre-existing carotid stenosis, INVOS sensor will be applied on the same side. In case of pre-existing cerebral pathology, the INVOS sensor will be applied to the contralateral side. Baseline values of nominal stroke index (SI), cardiac index (CI), BIS, mean arterial pressure (MAP) and regional oxygen saturation (rSO2) will be recorded. Basal rSO2 will be recorded prior to preoxygenation which raises the value. • Before the induction, up to 250ml of balanced crystalloid solution will be administered. These will include antibiotics solvents and other pre-induction i.v. therapy.
15960229|NCT03186326|Drug|Panitumumab|Administered at 6 mg/Kg
15960133|NCT03187041|Other|Sensation and Skin Surface Pressures Under Blood-Draw Tourniquets|"Phase 1: Skin surface pressures will be recorded by an investigator during each of the 10 applications of the tourniquet. All 10 tourniquet skin pressure measurements will take place in the Blood Draw clinic at the UCSD Medical Center in Hillcrest on the same day for a subject.
~Phase 2: The same 20 subjects will be subjected to a prolonged blood-draw tourniquet application for a duration of 70 minutes. The purpose of phase 2 is to determine whether there is an effect on sensation from prolonged blood tourniquet use. External skin pressures will not exceed 60mmHg. During this prolonged tourniquet application the investigators will monitor changes in hand sensation at 10-minute intervals using Semmes-Weinstein monofilaments on three peripheral nerves of the hand (median, radian, and ulnar)."
15960134|NCT03187028|Behavioral|Diet Only|Diet counseling will be delivered using visual communication (e.g., Skype). Participants will be provided a computer tablet for the intervention with participants randomized to receive diet counseling.
15960135|NCT03187028|Behavioral|Diet + Exercise|Diet and exercise counseling will be delivered using visual communication (e.g., Skype). Participants will be provided a computer tablet for the intervention with participants randomized to receive diet and exercise counseling.
15960136|NCT03187015|Drug|Entinostat|HDAC (histone deacetylase inhibitor)
15960137|NCT03187015|Drug|Midazolam|benzodiazepine central nervous system (CNS) depressant
15960138|NCT03187002|Device|Transcutaneous electrical nerve stimulation (TENS)|Transcutaneous electrical nerve-stimulation (TENS) is a nonpharmacologic means of pain control that delivers electrical currents through the skin. These pulses of electrical current reduce pain by peripheral and central mechanisms, TENS actives descending inhibitory systems in the central nervous system to reduce sensitivity to pain (hypoalgesia). Assessment of previous TENS research identifies intensity as a critical factor in efficacy-documenting high intensity as the best means of pain control, as the higher pulse allows for deeper tissue afferents to be activated. TENS has been researched in a number of settings as pain control, including cancer pain, lower back pain, labor, and a range of gynecologic procedures and disorders.
15960139|NCT03187002|Drug|Moderate IV Sedation|IV sedation with fentanyl and versed
15960140|NCT03187002|Other|SHAM: Transcutaneous electrical nerve stimulation (TENS)|Sham Transcutaneous electrical nerve stimulation (TENS) to ensure blinding
15960141|NCT03187002|Other|SHAM: Moderate IV Sedation|Sham IV to ensure blinding
15960142|NCT03186989|Drug|IONIS MAPTRx|"Part 1: IONIS MAPTRx is administered intrathecally at 4 week intervals over the course of a 13 week treatment period for dose levels A, B, C, and D.
~Part 2: IONIS MAPTRx is administered intrathecally at quarterly intervals for 48 weeks."
15960143|NCT03186989|Other|Placebo|A placebo is administered intrathecally at 4 week intervals over the course of 13 weeks in Part 1. No placebo is given in Part 2.
15960144|NCT03186976|Behavioral|Aggressive Risk Factor Control|"1.) Sleep apnea screening, therapy is recommended if apopnea-hypopnea (AHI) index is greater than 15, with a target index of less than 5.
~2) Counseling regarding alcohol reduction to 2 drinks/day for men, 1 drink/day for women, no binge drinking (>5 drinks at one setting).
~3) Participation in a 12 week structured, home-based exercise program and nutritional counseling. Weight reduction will be emphasized through modification of diet and exercise.
~4) An OMRON BP monitor will be supplied to each patient. A target SBP of <140/80 mm/Hg will be targeted.
~5) Smoking cessation - through local resources already established at each site 6) Management of diabetes to achieve HgA1c<6.5%"
15960145|NCT03186976|Other|Standard of Care|Recommendations based on current guidelines
15960146|NCT03186963|Procedure|No immobilization|Conventional wrist dressing
15960147|NCT03186963|Procedure|Volar splint|Volar plaster splint
15960148|NCT03186950|Procedure|Restoration with Stainless Steel Crowns|After finishing the endodontic treatment with Guedes-Pinto Paste, the restoration of the teeth will be made using Stainless Steel Crowns.
15960149|NCT03186950|Procedure|Restoration using BulkFill CR|After finishing the endodontic treatment with Guedes-Pinto Paste, the restoration of the teeth will be made using BulkFill composite resin
15960150|NCT03186937|Dietary Supplement|hominex-2|Hominex-2 is a methionine-free amino acid modified medical supplement
15960151|NCT03186924|Behavioral|Take a STAND for health|The Take a STAND for health is a newly developed 4-month goal-setting intervention aimed at reducing sedentary behavior
15960152|NCT03186911|Behavioral|E-liquid sampling and preference assessment|Participants will sample two different e-liquids that vary in nicotine content, complete questionnaires about each one, and then choose between the two e-liquids in a preference assessment task.
15960153|NCT03186898|Radiation|Proton Therapy (Radiation Therapy)|Undergo proton therapy
15960154|NCT03186898|Radiation|Photon Therapy (Radiation Therapy)|Undergo photon therapy
15960155|NCT03186885|Behavioral|Healthy Frio In-Person Family-focused Intervention|Participants learn about energy balance behaviors, skills to support health behavior change, managing personal wellness, and parenting strategies. Sessions use interactive learning strategies to elicit knowledge and experience of participating families to encourage families to learn from each other. YMCA staff members lead a 50-minute group exercise session after each health education session to help participants meet their commitment of engaging in PA at least 3 times/week.
15960156|NCT03186885|Behavioral|Healthy Frio Remote Technology Family-focused Intervention|Tablet computers will be used as the platform to deliver the health education content for the FI-RT. Each session will present the class content and guide the participants to complete class activities. Videos of health education and class activities (e.g., cooking demonstrations, exercise demonstrations) will be embedded in the lesson. Interactive assessment questions with feedback will be presented throughout the session to check for understanding of the content. Viewing time and responses to the assessment questions will be recorded to evaluate progress and comprehension. Participants will view the health education sessions at home as a family and discuss the content as prompted by lesson instructions.
15960157|NCT03186885|Behavioral|Control|Participants receive standard of care
15960158|NCT03186872|Behavioral|Digital behavioral program app|mobile app utilizing cognitive behavioral techniques to help alleviate anxiety
15960159|NCT03186859|Procedure|Roux-en-Y Gastric Bypass (RYGB) surgery|RYGB operation using surgeons' standard technique
15960160|NCT03186859|Procedure|Sleeve Gastrectomy (SG) surgery|SG surgery using surgeons' standard technique
15960230|NCT03186326|Drug|Cetuximab|Administered at 500 mg/m²
15960231|NCT03186326|Drug|Bevacizumab|Administered at 5 mg/Kg
15960165|NCT03186807|Diagnostic Test|ultrasonographic scan of fetal brain|"Routine measurement of BPD, HC, OFD, cisterna magna, cerebellum, lateral ventricle(1).
~specific measurements as follow:
~Parietoccipital fissures will be measured from the most external border of cortex to the luminar line.
~Lateral fissure depths will be measured from the most external border of the insular cortex to the interface confirmed between the subarachnoid space and the skull.
~Cingulate fissures will be measured in the mid-coronal plane tracing a perpendicular line from the median longitudinal fissure to the apex of the cingulate fissures.
~6. Calcarine fissures will be measured in the coronal transcerebellar plane as tracing a perpendicular line from the median longitudinal fissure to the apex of the calcarine fissures."
15960166|NCT03186794|Other|Treadmill exercise training|The target training heart rate range is 70-80% of heart rate reserve, computed as: 0.7 and 0.85 (peak heart rate minus resting heart rate) + resting heart rate. Subjects will exercise for 30 minutes per session, completing on average 3 sessions per week, over approximately 12 weeks. During the training session, heart rate, treadmill speed, treadmill inclination, perceived fatigability index and RPE will be recorded. In the event that subjects cannot sustain 30 minutes of continuous treadmill walking at the target intensity, an interval approach will be used in which walking at the target will be sustained at smaller training interval durations of no shorter than 5 minutes followed by an active rest interval that is no longer than 1.5 times the training interval until the subject achieves a total exercise time of 30 minutes, excluding the rest intervals. Each of these sessions will last about 60 minutes but slightly longer if an interval approached is used.
15960167|NCT03186781|Biological|VRC-FLUNPF081-00-VP (HA-F A/Sing)|VRC-FLUNPF081-00-VP (HA-F A/Sing) is an investigational influenza HA ferritin vaccine.
15960168|NCT03186781|Biological|VRC-FLUDNA082-00-VP (DNA A/Sing)|VRC-FLUDNA082-00-VP (DNA A/Sing) is an investigational influenza plasmid DNA vaccine.
15960169|NCT03186768|Behavioral|Soap on a rope hall pass intervention|School health and nutrition coordinators will be trained on how to make and utilize the soap on a rope hall pass to improve hand washing behavior in schools.
15960170|NCT03186755|Drug|Hyaluronic acid 0.05% & Ectoine 2.0%|Treatment of 1 drop three times a day in both eyes for 8 weeks
15960171|NCT03186755|Drug|Olopatadine hydrochloride ophthalmic solution 0.1%|Treatment of 1 drop two times a day in both eyes for 8 weeks
15960172|NCT03186742|Drug|Eplerenone 50 mg Tab|Eplerenone 50 mg Tab once a day
15960173|NCT03186729|Drug|Antithrombotic Agent|Anticoagulant or antiplatelet drugs
15960174|NCT03186716|Dietary Supplement|Colostrum|Enteral colostrum 20g/day powdered colostrum to be mixed in with water and given via nasogastric tube q4 hrs.
15960175|NCT03186716|Dietary Supplement|Maltodextrin|Control patients will be received enteral formula and maltodextrin mixed in with water and given via nasogastric tube as boluses q 4hrs.
15960176|NCT03186703|Behavioral|Tailored knowledge translation|Tailored knowledge translation strategies specific to evidence-based cancer prevention recommendations
15960177|NCT03186690|Other|Biodentine|
15960178|NCT03186690|Other|Mineral Trioxide Aggregate|
15960179|NCT03186677|Biological|ISU304/CB2679d/Dalcinonacog alfa 75~150 IU/kg|ISU304/CB2679d/Dalcinonacog alfa 75~150 IU/kg by intravenous or subcutaneous
15960180|NCT03186677|Biological|BeneFIX|BeneFIX 75 IU/kg, intravenous administration
15960181|NCT03186664|Device|Lokomat training|The neurorobotic treatment will be performed by using the Lokomat (Lokomat, Hocoma, Volketswil, Switzerland) device. The work load will be progressively adjusted based on the improvement of motor performances. Training parameters (weight support, etc) will be individually adapted. During the first Lokomat session, support will be set at 50% of the body weight and will be adapted on observation of the gait. The Lokomat motor guidance system will be first set at 100%, corresponding to a passive walk.
15960182|NCT03186664|Drug|Sativex|"Patients in treatment with Sativex will receive cannabis-based medicine extract presented in a pump action sublingual spray. Sativex is composed of whole cannabis plant extract, containing THC (27 mg/mL) and CBD (25 mg/mL), in ethanol/propylene glycol (50:50) excipient.
~Each actuation delivers 100 KL of spray, containing THC 2.7 mg and CBD 2.5 mg. The number and frequency of dosing (sprays) with Sativex will vary from individual to individual and it may take a number of weeks to find the correct dose of Sativex for the individual patient."
15960183|NCT03186651|Device|TVS|Efficacy of a novel intra-vaginal device for temporary reduction of urine leakage in women suffering from stress urinary incontinence and to evaluate the safety and ease of use.
15960184|NCT03186638|Drug|Ibuprofen|Given PO
15960185|NCT03186638|Other|Placebo|Given PO
15960186|NCT03186638|Other|Questionnaire Administration|Ancillary studies
15960187|NCT03186625|Drug|Compound Panax Notoginseng Granule|"Dosage form:granule. Composition: Panax notoginseng,Codonopsis pilosula,Salvia miltiorrhiza,Pinellia ternata,Medicated Leaven,Coptis chinensis,Citrus reticulata Blanco,etc.
~Frequency:two times a day, one package per time. Duration:three months."
15960188|NCT03186625|Drug|Placebo Granule|Placebo granule has the same as Compound Panax Notoginseng Granule in the appearance, shape,colour,taste,frequency and duration.
15960189|NCT03186612|Behavioral|OT+VR intervention with videogames for the upper limb (dexterity)|Patients will performe exercises with video capture of the upper limb movements via the performance of functional and manual dexterity activities based on the following games: Flip Out, Air Hockey, Particlesículas, Dunkit, Cuenta PecesCounting fishes and Robo Maro.
15960190|NCT03186599|Behavioral|low adherence intervention group|Monthly, the study coordinator will give calls to encourage physical activities and medication adherence using MEMS and WALKON activity data.
15960191|NCT03186586|Drug|Ulipristal acetate|5mg/day/five days
15960192|NCT03186586|Drug|Placebo|Placebo one pill a day for 5 days at the bleeding episode
15960193|NCT03186573|Dietary Supplement|Grape juice|400ml diary of grape juice
15960194|NCT03186573|Dietary Supplement|Maltodextrin|400ml diary of maltodextrin
15960195|NCT03186560|Device|gekoTM|The geko™ W devices are small disposable, internally powered, neuromuscular stimulators that are applied externally to the leg. The W device has a fixed 27mA current. The devices are self-adhesive and are applied to the outer/posterior aspect of the knee. This positioning enables integral electrodes to apply a stimulus to the lateral popliteal nerve (often additionally termed the common peroneal) which branches from the sciatic nerve. This nerve controls the contraction of several muscles in the lower leg.
15960232|NCT03186326|Drug|Aflibercept|Administered at 4 mg/Kg
15960196|NCT03186547|Drug|Botulinum Toxin A Injection|adult patients with gummy smile due to hypermobile upper lip will receive Botulinum Toxin A Injection with a single injection1 cm lateral to the ala horizontally and 3 cm above the lip line vertically.
15960197|NCT03186547|Procedure|Modified Lip Repositioning Surgery|the surgical procedure will be done by removal of strip of epithelium by careful dissection and stabilizing the new mucosal margin to the gingiva to improve the gingival display in adult patients with gummy smile.
15960198|NCT03186534|Behavioral|2GETHER|Communication skills, coping skills, problem-solving, acceptance, HIV prevention
15960199|NCT03186534|Behavioral|Positive Affect Enhancement|coping skills for enhancing positive emotions, mindfulness
15960200|NCT03186508|Behavioral|Optimize Sleep (OS)|"All children will receive 8 sessions during active treatment: two in-person weekly, three in-person biweekly, and 3 monthly sessions conducted by phone. All families will be asked to complete 3 sleep challenges (at weeks 8, 16, and 20). During maintenance, families will continue with monthly phone contact."
15960201|NCT03186508|Behavioral|Optimize Sleep-Plus (OS-Plus)|"All children will receive 8 sessions during active treatment: two in-person weekly, three in-person biweekly, and 3 monthly sessions conducted by phone. All families will be asked to complete 3 sleep challenges (at weeks 8, 16, and 20). During maintenance, families will continue with monthly phone contact."
15960202|NCT03186495|Drug|Somapacitan|All subjects will receive three (0.08 mg/kg) consecutive once-weekly s.c. (under the skin) administrations of somapacitan
15960203|NCT03186482|Drug|Descovy® (TAF/FTC)|25/200 mg once daily for 28 days (DAYS 1-28).
15960204|NCT03186482|Drug|Viread® (TDF)|245 mg once daily for 28 days (DAYS 57-84).
15960205|NCT03186482|Drug|Rifadin® (Rifampicin)|600 mg once daily for 28 days (DAYS 29-56).
15960206|NCT03186469|Behavioral|Safety Baby shower|"A Safety Baby Shower using didactic and experiential teaching methods to educate participants on safety topics focused on reducing infant mortality. Participants receive safety products as their shower gifts with education on appropriate use of the products. The relaxed setting also encourages participants to seek answers and clarify myths from credible sources not otherwise available among family and friends. For intervention provides information on the infant's sleep position, bedding, co-sleeping, and tobacco exposure, all of which, alone or in combination, are risk factors for sleep-related deaths in infants. Breastfeeding, a protective factor for SIDS, will be encouraged."
15960207|NCT03186469|Behavioral|Standard of Care|Participants will received standard of care in regards to infant injury prevention. Written material on car seat safety, prevention of abusive head trauma, and safe sleep environments will be provide to participants.
15960208|NCT03186456|Biological|Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)|Allogeneic umbilical cord mesenchymal stem cells will transfusion into by forearm intravenous transplantation, 0.5 - 1 *10^6/kg. once a month, total 3 times.
15960209|NCT03186456|Drug|Aspirin Tablet|Drug: Aspirin Tablet, 100 mg/d
15960210|NCT03186443|Drug|Pregabalin|Pregabalin was taken 300mg,q 12h for 6 month.
15960211|NCT03186443|Drug|Gabapentin|Gabapentin was taken 0.4, tid for 6 month.
15960212|NCT03186430|Behavioral|Comprehensive Vaccine Promotion Package|"Practice-level components: Periodic feedback on adolescent immunization coverage. Assistance with implementing and utilizing standing orders for adolescent vaccine administration in the practice, utilizing standardized materials as provided by the Centers for Disease Control and Prevention and the Immunization Action Coalition. Identification of an immunization champion to facilitate immunization activities in the practice. Linkage to peer-to-peer training on adolescent vaccination through the Georgia Educating Providers In their Communities (EPIC) program.
~Provider-level components: Providers will receive standardized talking points, vaccine promotion scripts and answers to frequently asked questions, with training on how best to discuss, recommend and answer questions about vaccines.
~Patient/Parent-level components: An iPad tablet-based educational presentation will be provided for parents while they are waiting with their adolescent child in the examination room."
15960213|NCT03186417|Biological|2 million hMSC/kg|2 million hMSCs/kg infusion
15960214|NCT03186417|Biological|4 million hMSC/kg|4 million hMSC/kg infusion
15960215|NCT03186417|Biological|6 million hMSC/kg|6 million hMSC/kg infusion
15960216|NCT03186417|Biological|placebo|placebo infusion
15960217|NCT03186404|Drug|Atorvastatin|Atorvastatin 40mg OD
15960218|NCT03186404|Drug|Placebo oral tablet|Placebo
15960219|NCT03186391|Other|Data collected|Use the data collected during a usual consultation to study the relationship between different parameters (rest pressure ...) and imaging
15960220|NCT03186378|Combination Product|VP-102 with applicator|Subjects will receive treatment to their molluscum contagiosum with VP-102.
15960221|NCT03186365|Drug|Zepatier Oral Product|Grazoprevir, an HCV nonstructural protein 3/4A (NS3/4A) inhibitor 100 mg, plus elbasvir, an HCV NS5A inhibitor 50 mg fixed dose combination,Zepatier Oral Product, will be prescribed for 8-12 weeks
15960222|NCT03186352|Procedure|photoactivated disinfection|"After manual preparation of the cavity with an excavator and taking a sample for a microbial analysis with a rose bur on micro motor (size 014) the cavity undergoes the procedure of photodynamic disinfection:
~application of photosensitizer 'Fotosan' Agent (CMS Dental, Denmark) for 5 minutes, radiation with low power laser, wavelength 635 nm power 200mW 120 s. ('Lasotronix', DiodeLX model SMART) rinsing with water and drying"
15960223|NCT03186339|Procedure|TAVI|transfemoral transcatheter aortic valve implantation
15960224|NCT03186339|Procedure|SAVR|isolated surgical valve replacement
15960225|NCT03186339|Other|MM|management of aortic stenosis by medical treatment only
15960226|NCT03186326|Drug|FOLFOX regimen|"A course of treatment every 14 days
~Oxaliplatin: 85 mg/m² IV over 2 hours Folinic acid: 400 mg/m² (or 200 mg/m² if Elvorine) IV over 2 hours 5FU bolus: 400 mg/m² IV bolus over 10 minutes in 100 ml 0.9% NaCl 5FU continuous: 2,400 mg/m² in NaCl 0.9% in IV over 46 hours"
15960227|NCT03186326|Drug|FOLFIRI Protocol|"A course of treatment every 14 days
~Irinotecan: 180 mg/m² IV over 1H30 Folinic acid: 400 mg/m² (or 200 mg/m² if Elvorine) IV over 2 hours 5FU bolus: 400 mg/m² IV bolus over 10 minutes in 100 ml 0.9% NaCl 5FU continuous: 2,400 mg/m² in NaCl 0.9% in IV over 46 hours"
15960228|NCT03186326|Drug|Avelumab|"A course of treatment every 14 days. Premedication obligatory with antihistamines and paracetamol (example: 25-50 mg diphenhydramine and 500-650 mg paracetamol) IV, approximately 30 to 60 minutes before each dose of avelumab.
~Then:
~Avelumab: 10 mg/kg IV in 1 hour diluted with 0.9% saline solution; alternatively a 0.45% saline solution can be used if needed"
15960233|NCT03186313|Drug|Dactavira Plus|1 Single daily dose (2 Tablets) of Dactavira Plus each tablet contains (EPGCG 200 mg , Sofosbuvir 200mg, Daclatasvir 30 mg, Ribavirin 400 mg) for 12 weeks.
15960234|NCT03186313|Drug|Sofosbuvir + Daclatasvir + Ribavirin|Daily dose including Sofosbuvir 400 mg , Daclatasvir 60 mg & Ribavirin 800 mg for 12 weeks.
15960235|NCT03186313|Drug|Dactavira|Single daily dose (1 Tablet) of Dactavira each tablet contains (EPGCG 400 mg , Sofosbuvir 400mg, Daclatasvir 60 mg) for 12 weeks
15960236|NCT03186313|Drug|Sofosbuvir + Daclatasvir|Daily dose Sofosbuvir 400 mg & Daclatasvir 60 mg for 12 weeks
15960237|NCT03186300|Device|PEPPER system|In the phase 1 participants will use PEPPER safety system (with the CBR algorithm enabled) and in the phase 2 participants will use whole PEPPER system (with the CBR algorithm integrated).
15960238|NCT03186287|Other|Eccentric training|Eccentric phase of resistive shoulder exercises will be performed three sets of 15 repetitions once a day for 12 weeks using therabands. Participants will be supervised by the physiotherapist 3 days a week for the first 6 weeks, 2 days a week for the next 3 weeks and 1 day a week for the last 3 weeks.
15960239|NCT03186287|Other|Concentric training|Concentric phase of resistive shoulder exercises will be performed three sets of 15 repetitions once a day for 12 weeks using therabands. Participants will be supervised by the physiotherapist 3 days a week for the first 6 weeks, 2 days a week for the next 3 weeks and 1 day a week for the last 3 weeks.
15960240|NCT03186287|Other|Standard physiotherapy|The participants will receive standard physiotherapy. The standard physiotherapy exercises will be supervised by the physiotherapist, same as intervention exercises.
15960241|NCT03186274|Behavioral|Facilitated Group Session|Participants will review the SPIKES model with a facilitator and then participate in a guided and supported simulated patient encounter utilizing aspects of the SPIKES model, with feedback at the end of the session.
15960242|NCT03186274|Behavioral|CELA Session|Participants will review the SPIKES model on their own and then participate in a simulated patient encounter utilizing the SPIKES model. They will receive feedback following the encounter.
15960243|NCT03186261|Drug|Nano silver fluoride solution|Nano silver fluoride that composed of silver nanoparticles, chitosan and fluoride that combines preventive and antimicrobial properties.
15960244|NCT03186261|Drug|Cavity Cleanser|Moistens dentin surface after cavity preparation using a micro brush.
15960245|NCT03186248|Procedure|Per oral endoscopic myotomy|General anesthesia will be administered and an esophagogastroduodenoscopy will be performed. Mucosal incision proximal to the gastroesophageal junction (GEJ) will be identified depending on short or long myotomy. A 1.5- to 2-cm mucosal incision will be performed after raising a submucosal wheal. The endoscope will be inserted to create a submucosal tunnel with a combination of blunt dissection, carbon dioxide insufflation, hydro dissection and careful electrocautery. The tunnel will be extended past the GEJ, 3 cm onto the gastric cardia. after myotomy, the mucosal incision will then be closed using standard endoscopic clips.
15960246|NCT03186235|Other|Flow cytometry|Isolation of T regulatory cells from blood
15960247|NCT03186222|Diagnostic Test|blood sample|"Serum PRL levels are measured using ELISA assay kit in both groups and correlated with severity of acne in acne group.
~The genomic DNA from peripheral leukocytes is extracted. Genotyping of 1149G/T single nucleotide polymorphism (SNP) PRL extrapituitary promoter is done in acne patients and healthy individuals (control group) using PCR-RFLP method."
15960250|NCT03186196|Dietary Supplement|Diet containing Folate|
15960251|NCT03186183|Behavioral|GPS program|GPS is a sexual health promotion and HIV prevention program. It has 4 components: provision of information on HIV and sexually transmitted infections, motivational interviewing counselling, sexual health behavioural skills building, and linkage to care in the local community (e.g., referrals to medical, social service, social, mental health, and substance use programs). Among HIV-positive men who have sex with men (MSM) GPS is associated with positive health outcomes including decreased likelihood of condomless anal sex (CAS), particularly CAS with serodiscordant partners. GPS is also associated with decreased fear of being rejected for insisting on condom use and increased condom use self-efficacy.
15960252|NCT03186170|Other|SSA sperm selection|The investigators propose to assess one method of sperm selection based on the characteristics of spermatozoa recently introduced: Sperm Selection Assay, which used a gradient of concentration of progesterone to act as chemoatractant of spermatozoa of better quality. We will assess in vitro fertilization with two techniques (SSSA versus traditional technique of swin up) as well as embryo development.
15960253|NCT03186157|Procedure|Decompressive craniectomy|Decompressive craniectomy is a surgical procedure used to treat patients with acute intractable intracranial hypertension. It includes removing a large portion of lateral skull wall in order to alleviate the effects of increased intracranial pressure and allow the brain to expand.
15960254|NCT03186157|Procedure|Cranioplasty|Cranioplasty is a routine neurosurgical procedure to repair the continuity of the bone tissue of the skull with autologous bone or synthetic bone flap from heterologous material.
15960255|NCT03186144|Genetic|Blodd punction for genetic analysis|
15960256|NCT03186131|Drug|Ibandronate|To examine the efficacy of oral Ibandronate in osteoporosis
15960257|NCT03186131|Drug|Oral Ibandronate and Vitamin D|To examine the efficacy of oral Ibandronate and Vitamin D in osteoporosis
15960258|NCT03186118|Biological|T-cell Antigen Presenting Cells expressing truncated CD19 (T-APC)|Autologous CD4 and CD8 T cells transduced to express a truncated CD19 (CD19t) Transgene
15960259|NCT03186105|Other|Ambulatory appendicectomy|The intervention consist of an ambulatory care by appendicectomy of the acute appendicitis. The normal care is an appendicectomy and an hospitalisation during 2 or 3 days .
15960285|NCT03185923|Drug|TCM placebo plus conventional drug|"All patients were treated with antibiotics according to international guidelines. The control group will receive TCM placebo according to the TCM syndrome.
~placebo qingfeijieduhuatan granule (Sanjiu Medical & Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for phlegm-heat obstructing in the lung syndrome every day in 28 treatment days.
~placebo zaoshihuatanxiefei granule (Sanjiu Medical & Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for pulmonary stagnation of phlegm syndrome every day in 28 treatment days.
~placebo qingxinkaiqiao granule (Sanjiu Medical & Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for Pathogenic heat trapping the pericardium syndrome every day in 28 treatment days."
15960260|NCT03186092|Other|respiratory muscle training|The TMI protocol will be performed with POWERbreathe Line Plus (POWERbreathe International Ltd. Warwickshire, England) linear loader with resistance load of 30% of maximal inspiratory pressure (PImax) value for a period of 12 weeks, 7 times at Week, 30 min / day, one of the times in the week with the supervision of the researcher and, on the other six days of the week, patients will perform IMT at their homes, having as a control a records record of the protocol that will be delivered to each patient To record the time and duration of the exercise. At the end of each week, patients will be reevaluated for MIP, so that the load values are regulated according to the possible increase in inspiratory muscle strength. The data collection will be performed by a single evaluator and the patients will be properly oriented on the procedures to be performed.
15960261|NCT03186092|Other|sham muscle training|sham comparator
15960262|NCT03186079|Drug|Xiaojidaozhi Decoction oral capsules|Capsules with mixture of twelve Chinese herbal medicines granule inside
15960263|NCT03186079|Drug|Placebo oral capsules|Capsules with flour granule inside
15960264|NCT03186079|Drug|Fiberform|Fiberform is a low-phytate wheat fibre which can increase the gastrointestinal motility.
15960265|NCT03186079|Behavioral|Toilet training|Toilet training has been considered a routine method in treatment of constipation
15960266|NCT03186066|Device|Flamingo Device|Endoscopic Treatment of Buried Bumper Syndrome with the Flamingo Device
15960267|NCT03186066|Procedure|Standard Therapy|Endoscopic Treatment of Buried Bumper Syndrome with an endoscopic submucosal dissection knife
15960268|NCT03186053|Drug|sodium creatine phosphate|sodium creatine phosphate .Loading dose followed by continuous infusion in operation
15960269|NCT03186053|Drug|saline|.Loading dose followed by continuous infusion in operation
15960270|NCT03186040|Drug|Lacosamide|Sodium channel blocker
15960271|NCT03186027|Dietary Supplement|Coenzyme Q10 plus NADH|"Active arm: Coenzyme Q10 plus NADH CFS/ME patients who will be randomized to measure the effect of oral ReConnect supplementation (CoQ10: 200 mg/day plus NADH 20 mg/day; 4 tablets/day) on changes in the fatigue, sleep problems, autonomic function and HRQoL during 8-weeks in term.
~Intervention: Reconnect"
15960272|NCT03186027|Dietary Supplement|phosphoserine plus vitamin C|"Placebo arm: phosphoserine plus vitamin C CFS/ME patients who will be randomized to measure the effect of oral Placebo supplementation (phosphoserine and vit C, 4 tablets/day) on changes in the fatigue, sleep problems, autonomic function and HRQoL during 8-weeks in term.
~Intervention: placebo"
15960273|NCT03186014|Device|Fully covered irradiation stent|A esophageal fully covered segmented irradiation stent loaded with 125I seeds is placed in Patients with malignant dysphagia
15960274|NCT03186001|Drug|Abobotulinum toxin A|The purpose of this study is to describe two safe and reproducible techniques upper face botulinum toxin injection. It will also describe the effect of both techniques on the eyebrow shape and height using quantitative, objective measurements and subjective scales
15960275|NCT03185988|Drug|chemotherapy in combination with trastuzumab for arm1|Arm1: GI tumor beyond CRC, ESCC, BTC and GC&GEJA Trastuzumab (Herceptin ®): 6 mg/kg every 3 weeks (8 mg/kg as loading dose at 1st administration), iv, d1.The first infusion is to be given over 90 minutes, and subsequent infusions are to be given over 30 minutes if the first infusion is well tolerated.Combined chemotherapy (by investigator's choice)
15960276|NCT03185988|Drug|chemotherapy in combination with trastuzumab for arm2|Arm2: esophageal squamous cell carcinoma (ESCC) Trastuzumab (Herceptin ®): the same as above Combined with Irinotecan: 120 mg/m2 IV, day 1 and day 8, every 3 weeks.
15960277|NCT03185988|Drug|chemotherapy in combination with trastuzumab for arm3|"Arm 3: biliary tract cancer (BTC) Trastuzumab (Herceptin®): the same as above Combined chemotherapy (by investigator's choice) The combined chemotherapy of cohort 1 and 3 is Irinotecan: 120 mg/m2 IV, day 1and day 8, every 3 weeks.
~OR 5-Fu: 720 mg/m2/day, continuous IV. Infusion over 5 days, every 3 weeks. OR Capecitabine(Xeloda®):1000 mg/m2 bid, d1-d14, every 3 weeks. The chemotherapy regimen is chosen at the Investigator's discretion and can be determined on an individual patient basis. Special cases should be discussed with the principal investigator."
15960278|NCT03185988|Drug|chemotherapy in combination with trastuzumab for arm4|Trastuzumab (Herceptin ®): same as above Combined with Irinotecan: 120 mg/m2 iv, day 1and day 8, every 3 weeks. OR Capecitabine(Xeloda®)1000 mg/m2 bid, d1-d14, every 3 weeks. OR Irinotecan: 120 mg/m2 iv, day 1and day 8 and Capecitabine(Xeloda®)1000 mg/m2 bid, d1-d14, every 3 weeks (by investigator's choice)
15960279|NCT03185975|Behavioral|at-home test kit|Transgender youth in the control arm will receive test kits, but will not receive any testing intervention. Once individual results are reported, participants will be contacted via phone or email by study staff with options for referrals to services. Participants will complete follow-up surveys at 3, 6, 9, and 12 months post-testing.
15960280|NCT03185975|Behavioral|Motivational Interviewing and Certified Testing and Referral|Transgender individuals randomized to the experimental group (MI/CTR) will receive HIV counseling and testing via an online, HIPPA-compliant videoconferencing service. The session will last less than one hour and focus on HIV testing, prevention strategies, and/or linkage to HIV care, depending on the individual's test results. Participants will complete follow up surveys at 3, 6, 9 and 12 months.
15960281|NCT03185949|Device|Endobar Infusion Catheter System|Bariatric embolization with microspheres using Endobar Infusion Catheter System
15960282|NCT03185949|Behavioral|Behavioral therapy|Healthy diet and exercise
15960283|NCT03185936|Procedure|pars plana vitrectomy with internal limiting membrane (ILM) peeling|pars plana vitrectomy (PPV) combined with internal limiting membrane (ILM) peeling, endolaser photocoagulation and gas tamponade in management of optic disc pit (ODP) maculopathy.
15960284|NCT03185923|Drug|TCM plus conventional drug|"All patients were treated with antibiotics according to international guidelines. The Experimental group will receive TCM according to the TCM syndrome.
~qingfeijieduhuatan granule (Sanjiu Medical & Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for phlegm-heat obstructing in the lung syndrome in 28 treatment days.
~zaoshihuatanxiefei granule (Sanjiu Medical & Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for pulmonary stagnation of phlegm syndrome in 28 treatment days.
~qingxinkaiqiao granule (Sanjiu Medical & Pharmaceutical Co., Ltd.), 10g/packet, twice daily, for Pathogenic heat trapping the pericardium syndrome in 28 treatment days.
~shenmai injection（Sichuan chuanda west China Pharmaceutical Co., Ltd.）,15ml/ ampulla, 10～60ml each time (when needed), for yin exhausted syndrome in 28 treatment days.
~shenfu injection（Sanjiu Medical & Pharmaceutical Co., Ltd.）,10ml/ ampulla, 50～100ml each time (when needed), for yang exhausted syndrome in 28 treatment days."
15960287|NCT03185910|Behavioral|Hospital-based antenatal education|Hospital-based antenatal education involves all aspects of pregnancy, childbirth and postpartum.
15960289|NCT03185884|Other|Control|control carbohydrate blend
15960290|NCT03185884|Other|Experimental|experimental carbohydrate blend
15960291|NCT03185871|Drug|Celecoxib|Celecoxib is the only COX-2 inhibitor currently approved by the FDA to be used in the United States. Recently, it has been shown that celecoxib prevents sporadic colorectal adenomas and there are more clinical trials evaluating the use of celecoxib in combination with chemotherapy regimens in breast cancer settings. Celebrex® oral capsules that will be used in this study contain 200 mg of celecoxib, in combination with inactive ingredients that include the following components: croscarmellose sodium, edible inks, gelatin, lactose monohydrate, magnesium stearate, povidone and sodium lauryl sulfate.
15960292|NCT03185858|Behavioral|SINEMA intervention|"Provider-facing intervention includes the following components:
~(1) Systematic cascade training for village doctors; (2) monthly follow-up visits with the support of the SINEMA APP; (3) village doctor group activities; (4) performance feedback and incentives.
~Stroke survivor-facing intervention program includes the following components:
~(1) Briefing session; (2) monthly follow-up visits and follow-up handout; (3) daily voice message for health education."
15960293|NCT03185845|Drug|Warfarin|tailored dose according to international normalized ratio (INR) for 3 months
15960294|NCT03185832|Device|CRT-D|This subject cohort is made by all patients enrolled and implanted with defibrillator with CRT capabilities
15960295|NCT03185832|Device|ICD|This subject cohort is made by all patients enrolled and implanted with defibrillator capabilities
15960296|NCT03185832|Device|PM / CRT-P|This subject cohort is made by all patients enrolled and implanted with pacemakers with or without CRT capabilities
15960297|NCT03185832|Other|Non-device|Patient enrolled but not implanted with a Defibrillator or Pacemaker
15960304|NCT03185806|Device|Puncture and drainage|The enrolled SAP patients are punctured under guidance of B ultrasound or CT scan, and prolonged drained by 8-F or 10-F pigtail tube
15960305|NCT03185793|Drug|Placebo|Placebo once daily for 5 weeks
15960306|NCT03185793|Drug|SHR4640|1mg SHR4640 once daily for a week, 2.5mg, 5mg or 10mg SHR4640 once daily for 4 weeks
15960307|NCT03185793|Drug|benzbromarone|25mg benzbromarone once daily for a week, 50mg benzbromarone once daily for 4 weeks
15960308|NCT03185780|Other|Acupuncture|"Acupuncture: the insertion of use of ultra-fine needles (diameter 0.18 - 0.30mm) into designated acupoints in the skin, along the limbs and trunk areas.
~Reflexology: The massage + application of localized pressure on designated points along the plantar aspect of the feet.
~Shiatsu: The application of localized pressure along designated points (similar to acupoints) along the limbs and trunk areas."
15960309|NCT03185767|Other|blood sampling|blood sampling
15960310|NCT03185754|Procedure|Sublobar resection|Sublobar resection
15960311|NCT03185754|Procedure|lobectomy|lobectomy
15960312|NCT03185741|Behavioral|UMS Strategy|Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.
15960313|NCT03185741|Behavioral|SMS Text Messaging|Patients will receive daily text message reminders about when to take medicines based on UMS intervals.
15960314|NCT03185728|Other|iLook Out for Child Abuse|"Online, interactive educational intervention that uses a video-based story-line and gamification to teach childcare providers about child abuse and mandated reporting."
15960315|NCT03185715|Behavioral|Oral and written counselling|Recipients were informed about success rates of SET and DET and also about the possible risks of DET. All the information was given orally and written.
15960316|NCT03185702|Genetic|Research genetic tests|DNA and tissue-based tests: karyotype, copy number variants, genome-wide association studies and induced pluripotent stem cells
15960317|NCT03185689|Behavioral|Effectiveness of an intensified DSME in T2D adult patients|
15960318|NCT03185676|Other|Bilberry|A bilberry based probiotic beverage
15960319|NCT03185676|Other|beverage without bilberries or probiotics|A control beverage without bilberries or probiotics
15960320|NCT03185663|Other|traction-stuck|continuous pulling method: tensile force is exerted directly on the skin by means of adhesive strips, connected to weight
15960321|NCT03185663|Other|a pillow between the legs|setting up a pillow between the legs before the care
15960322|NCT03185650|Device|tPAD Device|A novel, transnasal aerosol generator
15960323|NCT03185650|Device|PARI LC Star Nebulizer|Standard oral nebulizer
15960324|NCT03185637|Procedure|Various interventions for each of the conditions.|"This is an observational study. Patients were not allocated to different interventions.
~Common interventions for each of the conditions, which will be compared during analysis include the following:
~Gastroschisis - primary operative closure, surgical silo, preformed silo. Anorectal malformation - various types of stoma, anoplasty, PSARP, other. Appendicitis - antibiotics, open appendicectomy, laparoscopic appendicectomy. Intussusception - air enema reduction, hydro-enema reduction, laparotomy. Inguinal hernia - open repair, laparoscopic repair."
15960325|NCT03185624|Drug|Rifaximin|Antibiotics
15960326|NCT03185611|Drug|Rifaximin|Antibiotics
15960327|NCT03185611|Drug|Azathioprine|immunomodulator
15960328|NCT03185585|Other|Mini Nutrition Assessment (MNA® )|MNA® is a validated nutrition screening and assessment tool that can identify geriatric patients age 65 and above who are malnourished or at risk of malnutrition.
15960795|NCT03182439|Device|Fit Bit Blaze|Fit Bit Blaze Heart Rate Monitoring Device
15960329|NCT03185585|Other|Comprehensive Older Adult Screening Tool (COAST)|Develop a comprehensive older adults screening tool for community dwelling older adults who attend congregate meal sites to assist in the evaluation of undernourishment or those at risk that is simple, faster, and less expensive
15960330|NCT03185559|Device|Relievion Device- Treatment Stimulation|1 Hour self-administered treatment specific occipital and supraorbital transcutaneous nerve stimulation
15960331|NCT03185559|Device|Relievion Device- Sham stimulation|1 Hour self-administered sham occipital and supraorbital transcutaneous nerve stimulation
15960332|NCT03185546|Other|NNC Spectrum Cigarette|Participants are provided with normal nicotine content Spectrum Cigarette for 13 weeks.
15960333|NCT03185546|Other|VLNC Spectrum Cigarette|Participants are provided with very low nicotine content Spectrum Cigarette for13 weeks
15960334|NCT03185546|Other|Moderate nicotine level e-liquid|Participants are provided with moderate nicotine level e-liquid for 13 weeks
15960335|NCT03185546|Other|Low nicotine level e-liquid|Participants are provided with very low or nicotine-free nicotine level e-liquid for 13 weeks
15960336|NCT03185546|Other|Tobacco Flavors|Participants can choose e-liquid flavors from a selection of tobacco flavors
15960337|NCT03185546|Other|Tobacco and non-tobacco e-liquid flavors|Participants can choose e-liquid flavors from a selection of flavors that includes tobacco and non-tobacco choices
15960338|NCT03185533|Behavioral|Quality improvement (QI) interventions|"1. The ED admissions exhibited prolonged length of stay.
~2. The Interventions for Reducing Medical Decision Time:
~The ED director created QI education sessions and reported monthly QI outcomes.
~The ED nurses reported the current number of ED admission patients twice a day to the director. The director summarized the bed requests to the administrative personnel.
~The nurses reported the in-scene complicated cases to the ED director. The director would give an assistance in managing these cases.
~3. The Interventions for Reducing Boarding Time
~The ED patients could be admitted before 8 a.m. if the bed was vacant.
~The ED director initiated an on-line meeting at 8 a.m. and 4 p.m.
~Monthly QI outcomes were reported in the hospital affairs meeting."
15960339|NCT03185507|Device|CryoHelmet|Cryotherapy was administered using the Catalyst CryoHelmet™ (All-Star Sporting Goods®, Shirley, Massachusetts, USA). The CyroHelmet is a flexible helmet equipped with gel ice packs meant to cool the head and neck.
15960340|NCT03185494|Biological|anti-CD19/22-CAR vector-transduced T cells|genetically engineered lymphocyte therapy
15960341|NCT03185481|Drug|1 mg QD to 15 mg QD PF-06649751|Up titration from 1 mg QD to 15 mg QD PF-06649751
15960342|NCT03185481|Drug|3 mg QD to 15 mg QD PF-06649751|Up titration from 3 mg QD to 15 mg QD PF-06649751
15960343|NCT03185481|Drug|7 mg QD to 15 mg QD PF-06649751|Up titration from 7 mg QD to 15 mg QD PF-06649751
15960344|NCT03185481|Drug|15 mg QD PF-06649751|15 mg QD PF-06649751 remaining at 15 mg QD PF-06649751
15960345|NCT03185481|Drug|1 mg QD to 7 mg QD PF-06649751 (if de-escalated in parent study)|Up titration from 1 mg QD to 7 mg QD PF-06649751 for subject at 1 mg QD who were blindly de-escalated in the parent study
15960346|NCT03185481|Drug|3 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study)|Up titration from 3 mg QD to 7 mg QD PF-06649751 for 3 mg QD subjects who were blindly de-escalated in parent study
15960347|NCT03185481|Drug|7 mg QD to 7 mg QD PF-06649751 (de-escalated in parent study)|7 mg QD to remain at 7 mg QD PF-06649751 for subjects who were blindly de-escalated in parent study
15960348|NCT03185481|Drug|15 mg QD de-escalated to 7 mg QD PF-06649751 in parent study remain at 7 mg QD|7mg QD PF-06649751 for subjects assigned to 15 mg QD who were blindly de-escalated to 7 mg QD PF-06649751 in parent study
15960349|NCT03185468|Genetic|4SCAR-PSMA|PSMA-specific 4th Generation CART
15960350|NCT03185468|Genetic|4SCAR-FRa|FRa-specific 4th Generation CART
15960351|NCT03185455|Other|Remote (text based) surveillance|Women with hypertensive disorders of pregnancy with access to a cell phone with unlimited text message capabilities will be randomized to either office visit blood pressure checks after discharge or receive a blood pressure cuff and text in blood pressures for two weeks postpartum using a standardized, HIPAA compliant, physician derived automated platform.
15960352|NCT03185442|Device|Pulsed Radiofrequency|Pulsed Radiofrequency is performed if the sensory threshold is below 0.5 volts, the PRF consists of 380 pulses
15960353|NCT03185429|Biological|Tumor Specific Antigen-loaded Dendritic Cells|Subjects will be given subcutaneous injection of 5.0x10^6-1.0x10^7 TSA-DC on week 1,3,5,11,17,23,35,47.
15960354|NCT03185429|Drug|Cyclophosphamide|300 mg/m2 by vein before the first cell infusion.
15960355|NCT03185416|Other|Palliative Care Training|The intervention group- will include 30 patients receiving treatment by the Interventional Radiology team along with their primary caregiver. Patients and caregivers will receive a brief palliative care training intervention during their first follow-up visit. Patients and their caregivers will receive questionnaires to assess their health status (physical and psychosocial) and health services utilization outcomes at 1, 2, and 3 months post-procedure during their follow-up visits.
15960356|NCT03185403|Other|paravertebral block|in the paravertebral block , the catheter was placed under ultrasound echography , at the right thoracic T4/T5 level
15960357|NCT03185403|Other|thoracic epidural block|in the epidural block the catheter was inserted without echography , at T4/T5 level
15960358|NCT03185403|Drug|ropivacaine|
15960359|NCT03185403|Drug|Sufentanil|
15960360|NCT03185390|Procedure|ERCP guided biopsy or brush cytology|ERCP guided biopsy or brush cytology
15960361|NCT03185364|Drug|Sildenafil Citrate|sildenafil treatment for 12 weeks, monitoring blood pressure and other adverse events
15960362|NCT03185364|Drug|Placebo Oral Tablet|placebos treatment for 12 weeks
15960363|NCT03185351|Drug|Bupivacaine|20 ml of 0.5% bupivacaine using supraclavicular BPB.
15960364|NCT03185351|Drug|Midazolam|midazolam 0.03 mg/kg dissolved in 5 ml normal saline (0.9%) using supraclavicular BPB
15960365|NCT03185351|Drug|Midazolam|0.03 mg/kg of midazolam by I.V. route
15960366|NCT03185338|Behavioral|Active commuting to/from school|Active transport to/from school on foot or by bike will be promoted
15960367|NCT03185338|Behavioral|Active Physical Education lessons|Specific lessons designed for increasing moderate to vigorous physical activity in Physical Education will be applied
15960368|NCT03185338|Behavioral|Active school recess|Teachers will design games and activities and will encourage children for being active
15960796|NCT03182439|Device|Garmin Forerunner 235|Garmin Forerunner 235 Heart Rate Monitoring Device
15960369|NCT03185338|Behavioral|Sleep health promotion|This intervention will aim to raise the awareness of the importance of having a good quality sleep at night and to teach healthy sleep behaviours that will contribute to improving sleep hygiene
15960370|NCT03185338|Behavioral|School global intervention|A simultaneous implementation of all four interventions (see the others arms) will be examined in one of the intervention schools.
15960371|NCT03185325|Other|bone marrow puncture and venous blood samples|bone marrow and peripheral blood samples are collected in non hodgkin lymphoma patients
15960372|NCT03185325|Other|venous blood samples|venous blood samples are collected in healthy voulnteers
15960373|NCT03185312|Diagnostic Test|skin biopsy|"Clinical evaluation including full history taking and dermatological examination will be done for all patients. Assessment of disease severity will be performed using VASI score for vitiligo and Global acne severity grading for acne vulgaris Skin biopsies will be taken from lesional and non-lesional skin of patients as well as controls. immunohistochemical staining using specific antibodies for detection of expression of JAK1, JAK2 and JAK3.
~Additionally, biopsies will be preserved in RNA later solution at -20°C. RNA isolation and real-time qPCR analysis will be performed for measurement of cutaneous JAK1, JAK2 and JAK3 gene expression."
15960374|NCT03185299|Other|Video|Patients randomized to the intervention arm will be contacted 48-72h before their procedure via telephone using a standardized script and will be provided a link to a website allowing posting of videos for public viewing
15960375|NCT03185299|Other|Standard preparation instructions|The control arm will receive written instruction on preparing for a colonoscopy per standard of care
15960376|NCT03185286|Device|3d-printed personalized metal implant|3d-printed personalized metal implant will be used in subtalar arthrodesis.
15960377|NCT03185247|Behavioral|Transdiagnostic Group-Based Treatment|10 week 90-minute weekly therapy sessions including both the adolescent and caregiver. Treatment will consist of psychoeducation about dysautonomia, motivational interviewing techniques to promote readiness for change, support around lifestyle and behavioral changes, core CBT components (e.g., relaxation training, linking thoughts, feelings, and behaviors, minimizing catastrophizing thoughts, cognitive coping, and exposure), and components of ACT aiming to increase cognitive flexibility (e.g., mindfulness, experiential avoidance, values, cognitive defusion, committed action), and relapse prevention and maintenance. Most sessions will involve homework assigned to the adolescent and their parent/legal guardian(s) to encourage practice at home.
15960378|NCT03185234|Device|anodal tDCS|2 mA, 10 min, 5 sessions
15960379|NCT03185234|Device|sham tDCS|sham stimulation, 10 min, 5 sessions
15960380|NCT03185221|Device|Cordimax|One rapamycin eluting stent for treating the adapted coronary patients
15960381|NCT03185221|Device|XIENCE V|One everolimus eluting stent for treating the adapted coronary patients
15960382|NCT03185208|Drug|Lithium Carbonate|See lithium carbonate arm
15960383|NCT03185208|Drug|Placebo oral capsule|See placebo arm
15960384|NCT03185195|Drug|AQX-1125 Oral Tablet|Part 1: Subjects will receive a single oral dose of AQX-1125 followed by [14C]-AQX-1125 IV Microtracer dose. In Part 2 subjects receive [14C]-AQX-1125 oral solution.
15960385|NCT03185195|Drug|[14C]-AQX-1125 IV|Part 1: Subjects will receive a single oral dose of AQX-1125 followed by [14C]-AQX-1125 IV Microtracer dose. In Part 2 subjects receive [14C]-AQX-1125 oral solution.
15960386|NCT03185195|Drug|[14C]-AQX-1125 Oral Solution|Part 1: Subjects will receive a single oral dose of AQX-1125 followed by [14C]-AQX-1125 IV Microtracer dose. In Part 2 subjects receive [14C]-AQX-1125 oral solution.
15960387|NCT03185182|Drug|Ioflupane I123|"185 MBq ioflupane I123 will be administered at one single occasion to the study subjects A one time dose of DaTSCAN is given via intravenous injection of 185 MBq Ioflupane (I123) .
~The patient takes potassium iodine tablets prior to the DatSCAN injection to protect the thyroid gland. At the time of the DaTSCAN examination, the patient is injected intravenously at slow rate with 185MBq DaTSCAN solution."
15960388|NCT03185169|Combination Product|Replens and coconut oil|
15960389|NCT03185156|Drug|Propofol|first dose 0.3mg/Kg propofol, then 1mg/Kg/hr micro-pump
15960390|NCT03185156|Drug|Normal saline|first dose 0.03ml/Kg placebo saline, then 0.1ml/Kg/hr micro-pump
15960391|NCT03185143|Drug|Naltrexone and Acetaminophen Combination|Treat a single Qualified Migraine attack.
15960392|NCT03185143|Drug|Sumatriptan 100 mg|One capsule contains Sumatriptan 100 mg and one capsule contains a sham for component B taken together to treat a single Qualified Migraine attack.
15960393|NCT03185143|Drug|Placebo|One capsule contains a sham for component A and one capsule contains a sham for component B taken together to treat a single Qualified Migraine attack.
15960394|NCT03185130|Drug|Normal Saline 5mL|Control arm subjects will receive Normal Saline 5 mL IV over 1 hour
15960395|NCT03185130|Drug|Normal Saline 20mL/kg|Study arm subjects will receive Normal Saline 20 mL/kg IV (up to 1000 mL) given IV over 1 hour,
15960396|NCT03185130|Drug|Prochlorperazine 0.15 mg/kg up to 10 mg IV|Standard Treatment Arm and Study Arm will recieve prochlorperazine 0.15 mg/kg up to 10mg IV slow push
15960397|NCT03185130|Drug|Diphenhydramine 1 mg/kg up to 50 mg IV|Diphenhydramine dose 1 mg/kg up to 50 mg IV slow push
15960398|NCT03185104|Drug|Silver Diamine Fluoride|Silver diamine fluoride solution is applied to the dried and exposed coronal and root surfaces of all teeth by means of a disposable microbrush.
15960399|NCT03185104|Drug|Distilled Water|Distilled water is applied to the dried and exposed coronal and root surfaces of all teeth by means of a disposable microbrush.
15960400|NCT03185091|Other|rapid ventricular pacing|
15960401|NCT03185091|Procedure|Surgery|
15960402|NCT03185078|Device|Extracorporeal Shock Wave Therapy|Extracorporeal shock wave therapy (ESWT) is a treatment method for the application of single-pulse acoustic pressure waves generated by sudden changes in pressure by creating shock waves with piezoelectric, electrohydraulic and electromagnetic systems. It has been reported that ESWT treatment is effective in the treatment of pain with hyperstimulation analgesia by inhibiting afferent pain receptors, and also improve angiogenesis and restore and reorganize the musculoskeletal system
15960403|NCT03185078|Other|Placebo ESWT|In the placebo application, rESWT device was switched on but without pressing the pedal during the same session period. The applicator was positioned to be the same as the other groups.
15960404|NCT03185065|Drug|Amantadine|100 mg of amantadine increased to 200 mg of amantadine, if tolerated
15960405|NCT03185065|Drug|Modafinil|100 mg of modafinil increased to 200 mg of modafinil, if tolerated
15960408|NCT03185052|Other|Manual puncture point compression|Manual puncture point compression following a diagnostic or therapeutic procedure by endovascular technique involving retrograde femoral puncture point with 5F guide catheter
15960409|NCT03185039|Procedure|Blood and tumor samples|Blood and tumor samples
15960410|NCT03185026|Behavioral|Interventional group : PEPSUI psychoeducational program|"The program includes 10 weekly, 2-hours sessions led by two trained animators (nurse, medical doctor/psychologist), each focusing on a specific theme or skill :
~Education on suicidal behavior (clinic and epidemiology), and conceptualization of the phenomenon on a matrix
~Education on the suicidal crisis, identification of important life areas and values for the patient, experimentation on the way to use the matrix as a decision-making tool.
~and 4) Self-assessment of suicidal ideations, coping strategies based on suicide ideation intensity and emotional tension (acceptation, distress tolerance, personal aid kit, and emergency care)
~5) Stress-diathesis model of suicidal behavior, innovating cognitive skills (defusion), and valued actions 6) Stress factors (psychiatric diseases and negative life events), resilience, and contact with present moment 7) Suicidal vulnerability, personal strengths 8) Social support, skills to create quality relationships"
15960411|NCT03185026|Other|Relaxation group|Participants will be included in a standardized relaxation program, consisting of 10 weekly sessions lasting 2 hours. There will be 2 therapists for each patients group. Abdominal and muscular relaxation skills will be experimented.
15960412|NCT03185013|Biological|VGX-3100|1 milliLiter (mL) VGX-3100 will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.
15960413|NCT03185013|Biological|Placebo|1 mL of Placebo will be injected IM and delivered by EP using CELLECTRA™-5PSP on Day 0, Week 4 and Week 12.
15960414|NCT03185013|Device|Electroporation (EP)|Intramuscular injection followed by EP with the CELLECTRA™ 5PSP device.
15960415|NCT03185000|Drug|TR004 (Treg immunotherapy)|Administered Intravenously (IV)
15960416|NCT03185000|Other|Placebo|Administered Intravenously (IV)
15960417|NCT03184987|Drug|FF/UMEC/VI 100/62.5/25 mcg|Subjects will self-administer the study treatment via the ELLIPTA device. The ELLIPTA holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 100 mcg in each blister and the second strip contains UMEC 62.5 mcg and VI 25 mcg in each blister. ELLIPTA is a registered trademark of GSK groups of companies.
15960418|NCT03184987|Drug|FF/UMEC/VI 200/62.5/25 mcg|Subjects will self-administer the study treatment via the ELLIPTA device. The ELLIPTA holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 200 mcg in each blister and the second strip contains UMEC 62.5 mcg and VI 25 mcg in each blister. ELLIPTA is a registered trademark of GSK groups of companies.
15960419|NCT03184987|Drug|Salbutamol|Salbutamol is a rescue medication administered via metered-dose inhaler (MDI) which will be used when needed during the study.
15960420|NCT03184987|Other|ACQ-7|ACQ-7 will be used for the assessment of control status of asthma.
15960421|NCT03184961|Diagnostic Test|lung recruitment maneuver|Lung recruitment maneuver (application of continuous positive airway pressure of 25 cm H2O for 20 s)
15960422|NCT03184948|Device|Brilliance|The intervention is the provision of the Brilliance phototherapy machines to hospitals. This device is to be provided to facilities regardless of the study -- the study's involvement has been to collaborate with the Ministry of Health so that Brilliance is distributed in a randomized staggered method. In that sense, the study may be considered observational, as the study is not driving whether or not a hospital receives Brilliance, only when it receives Brilliance in a short time frame.
15960423|NCT03184935|Biological|Allogeneic umbilical cord mesenchymal stem cells|Experimental group receive Allogeneic umbilical cord mesenchymal stem cell，i.v (SCLnow 19#)
15960424|NCT03184935|Drug|Decitabine|Decitabine，20mg/m^2/d
15960425|NCT03184922|Procedure|Adjustable versus fixed suspensory loop femoral side graft fixation|A comparison of 2 different types of surgical technique for attaching the femoral side graft in ACL reconstruction: with a fixed suspensory loop or an adjustable one
15960426|NCT03184909|Drug|Ocimum Sanctum|Active capsules containing leaves of organically prepared ocimum sanctum
15960427|NCT03184909|Drug|Placebo|Placebo capsules of look alike inert substance for control
15960428|NCT03184896|Procedure|Hip Fracture Surgery|Hip Fracture Surgery
15960429|NCT03184883|Procedure|single conventional denture|mandibular conventional denture with soft liner
15960430|NCT03184883|Procedure|single flexible denture|mandibular flexible compete denture
15960431|NCT03184870|Drug|BMS-813160|Specified dose on specified days
15960432|NCT03184870|Biological|Nivolumab|Specified dose on specified days
15960433|NCT03184870|Drug|Nab-paclitaxel|Specified dose on specified days
15960434|NCT03184870|Drug|Gemcitabine|Specified dose on specified days
15960435|NCT03184870|Drug|5-fluorouracil (5-FU)|Specified dose on specified days
15960436|NCT03184870|Drug|Leucovorin|Specified dose on specified days
15960437|NCT03184870|Drug|Irinotecan|Specified dose on specified days
15960438|NCT03184857|Procedure|open maxillary sinus lifting|biopsy of the region 6 months later
15960439|NCT03184844|Drug|Thalidomide|thalidomide:50mg/d p.o at bedtime
15960440|NCT03184831|Procedure|sinus lift, implant placement, sole bovine bone|sinus lift augmentation with a sole deproteinized bovine bone with simultaneous implant placement
15960441|NCT03184831|Procedure|sinus lift, implant placement, injectable PRF + bovine bone|sinus lift augmentation with a mixture of injectable platelet rich fibrin plus a deproteinized bovine bone with simultaneous implant placement
15960442|NCT03184818|Other|Advanced care|The pharmacist will assess for symptoms of urinary tract infection and, for patients in Arm 1, prescribe antibacterials when appropriate. For patients in Arm 2, pharmacists will ensure optimal therapy and adapt or perform therapeutic substitution when appropriate (or work with the patient to discontinue therapy or just put the prescription on file in instances where the patient is assessed to have asymptomatic bacteriuria for which treatment is inappropriate).
15960474|NCT03184519|Diagnostic Test|Pregnancy test|Instead of one blood sample, patients will have three blood analyses to predict pregnancy earlier after the embryo transfer.
15960556|NCT03184142|Behavioral|Simulation|Students witness the intimidation of one of their peers (who is an actor) by a professor (also an actor). (see arm description)
15960557|NCT03184142|Behavioral|Video|Student watch a 15-minute intimidation video (see arm description).
15960443|NCT03184805|Drug|Continuing aspirin|Subject assigned to control arm will maintain antiplatelet therapy using aspirin only at least 7 days before surgery. If subject is taking one or more antiplatelet drugs, it should be changed (for subjects taking antiplatelet drug except aspirin at enrollment) or continued (for subject taking aspirin at enrollment) with low-dose, aspirin monotherapy before surgery. Cessation of clopidogrel, ticagrelor, and prasugrel should be started at least 5 days, 3 days and 7 days before surgery, respectively. Administration of aspirin will be started at the day of cessation of previous antiplatelet regimen and maintained until third postoperative day with 100 mg once a day.
15960444|NCT03184805|Drug|Stopping aspirin|Subject assigned to comparison arm will stop antiplatelet therapy before scheduled surgery or procedure. If subject is taking aspirin, clopidogrel, ticagrelor, or prasugrel, it should be discontinued for 7 days, 5 days, 3-5 days, and 7 days before surgery. Antiplatelet therapy may be restarted as previous regimen at fourth postoperative day or sooner unless significant bleeding risk or bleeding event occurs.
15960445|NCT03184792|Device|Transcutaneous spinal stimulation|Non-invasive electrical stimulation of cervical spinal cord over the skin
15960446|NCT03184792|Other|Physical therapy|Physical therapy to improve arm and hand functions
15960447|NCT03184779|Other|Ski and Snowboard Safety Video|The ski and snowboard safety video (~10 minutes) includes information on preparation, correct protective equipment use (e.g. helmets), and strategies for speed control and collision avoidance. Focus groups were conducted among parents, students, ski patrol, and ski instructors to inform the content and format of the video. Feedback and suggestions from focus groups were utilized to ensure that the video optimized information uptake from children and adolescents who watch the video. The Health Action Process Approach (HAPA) model was embedded throughout the video to ensure evidence-informed pathways towards positive behaviour change.
15960448|NCT03184766|Drug|Test Nurofen Cold and Flu®, Ibuprofen and pseudoephedrine liquid capsules|2 x 200 mg ibuprofen & 30 mg pseudoephedrine
15960449|NCT03184766|Drug|Comparator 1 Nurofen Cold and Flu®, ibuprofen and pseudoephedrine tablets|2 x 200 mg ibuprofen & 30 mg pseudoephedrine
15960450|NCT03184766|Drug|Comparator 2 Nurofen Immedia 200 mg Weichkapseln, ibuprofen liquid capsules|2 x 200 mg solubilised ibuprofen
15960451|NCT03184753|Biological|OC-IgT cells|Autologous human OC-IgT cells.
15960452|NCT03184740|Device|Active Transcranial Direct Current Stimulation|For electrode placement, the criteria used by the 10/20 electroencephalography system will be obeyed and the electrodes will be positioned over Primary motor cortex, C3 area for the anode and Fp2 (contralateral supraorbital area) for the cathode electrode. A constant current of 2mA will be applied for 20 minutes.
15960453|NCT03184740|Device|Sham Transcranial Direct Current Stimulation|For electrode placement, the criteria used by the 10/20 electroencephalography system will be obeyed and the electrodes will be positioned over primary motor cortex, C3 area for the anode and Fp2 (contralateral supraorbital area) for the cathode electrode, but the stimulator will be turned off after 30 seconds of stimulation.
15960454|NCT03184714|Device|NIPPV|BiPAP treatment for 3 years
15960455|NCT03184701|Other|Telehealth|Patients will be given an ipad with preloaded app (secured questions assessing their symptoms and cognitive function in a systematic timely way). The responses will be delivered to the care providers instantly, which will trigger an algorithmic clinical approach.
15960456|NCT03184688|Procedure|platelet rich plasma|Ultrasound-guided PRP injection between proximal carpal tunnel and median nerve.
15960457|NCT03184688|Drug|Normal saline|Ultrasound-guided normal saline injection between proximal carpal tunnel and median nerve.
15960458|NCT03184675|Other|Functional action observation training|the Four Square Step Test (FSST) performance video for enhancing the dynamic balance and the video including participants' daily activities to increase the gait ability such as walking in a corridor, walking around the hospital, walking to the therapy room, coming out of the ward after opening and closing the door of it, coming in and out of toilet, shifting their blue plate. and bringing something from a refrigerator were produced and watched.
15960459|NCT03184675|Other|General action observation training|step 1, looking at the front, while walking comfortably; step 2, looking left and right, while walking; step 3, looking up and down, while walking; step 4, looking at the front, left and right, up and down while walking. After 15 minutes of watching the video, the exercise program with a therapist was conducted to increase the gait ability, for 15 minutes.
15960460|NCT03184662|Other|HIPA|"inclusion in a program with 2 weekly sessions of structured physical activity of 1 hour in a dedicated structure, under the supervision of a graduated coach.
~First 3 months : physical reconditioning 3 months and after: alternating sessions of physical strengthening and intermittent high-intensity physical activity Adaptation of the intensity of the program according to evaluation tests every 3 months"
15960461|NCT03184662|Other|Counseling PA|Counseling of physical activity according to recommendations from the working group on Physical Activity of the SFD
15960462|NCT03184649|Drug|Ibuprofen|It is a pre-analgesic will be taken before painful procedures.
15960463|NCT03184649|Drug|paracetamol|it is a pre-analgesic drug will be taken before painful procedure.
15960464|NCT03184649|Dietary Supplement|A fruit-flavored orange color placebo solution|orange juice as a comparative group.
15960465|NCT03184623|Other|muscle mass measurement|measurement of muscle mass by echocardiography
15960466|NCT03184610|Device|OCT-scanning|All participants will be scanned with a OCT-device
15960467|NCT03184597|Diagnostic Test|HLA screening before commencing aromatic AEDs|When the risk HLA alleles are tested positive for the patients, aromatic AEDs were avoided or administrated with caution according to the risk level.
15960468|NCT03184584|Drug|PBI-4050|Four 200 mg capsules (800 mg total) administered orally, once daily
15960469|NCT03184571|Drug|Bemcentinib; pembrolizumab|Bemcentinib is a selective Axl kinase inhibitor; pembrolizumab is a PD-1 inhibitor
15960470|NCT03184558|Drug|Bemcentinib; pembrolizumab|Bemcentinib is a selective Axl kinase inhibitor; pembrolizumab is a PD-1 inhibitor.
15960471|NCT03184545|Device|EMS|The EMS device Flex MT Plus (Electrostim Medical Services Inc. Tampa, FL) is a neuromuscular stimulator. It is approved by the FDA. The Electrical muscle stimulation (EMS) applied to vastus medialis obliquus (VMO) muscle for 20 minutes, 3 times daily and it would be 5 times a week for 12 weeks at 40 Hz. The pulse duration will be 0.26ms, at 5 seconds on and 10 seconds off.
15960472|NCT03184545|Other|Physical therapy|Standard physical therapy exercises
15960473|NCT03184532|Diagnostic Test|ultrasound|ultrasound examination of pyloric antrum
15960475|NCT03184506|Other|pre-warming|On arrival at the preoperative care unit, assignments were determined using an opaque sealed envelope opened by investigator with no clinical involvement in the study. In the pre-warming group, the forced-air blanket (COVIDIEN™ WarmTouch™ Full Body/Multi Access Blanket, Covidien Ilc, Mansfield, MA, USA) was positioned over the whole body except head and neck, covered by cotton blanket. Forced air warmer (COVIDIEN™ WarmTouch™ WT6000 Warming Unit, Covidien Ilc, Mansfield, MA, USA) was set to 'high level' (45℃) during 20 min. During the warming procedure, patients were asked every 5 min about their thermal comfort; if they felt overheated, the warmer was lowered to 41℃
15960476|NCT03184506|Other|no warming|patients were covered only with two layers of cotton blanket
15960477|NCT03184493|Drug|Celebrex plus Metformin|This group patients will receive metformin and celebrex.
15960478|NCT03184493|Drug|Celebrex|This group patients will receive celebrex.
15960479|NCT03184493|Drug|Metformin|This group patients will receive metformin.
15960480|NCT03184480|Drug|Arnuity Ellipta|The active component of Arnuity Ellipta is fluticasone furoate and it is indicated for the treatment of bronchial asthma. Post-marketing investigation of ARNUITY ELLIPTA will be carried out in this analysis.
15960481|NCT03184467|Drug|Normal Saline 0.9%|Normal saline 0.9% is subcutaneously administered once weekly schedule for 4 weeks (4 times) followed by every two weeks until week 24 (10 times). A total number of administration is 14 times.
15960482|NCT03184467|Drug|GV1001 0.56 mg|GV1001 0.56 mg is subcutaneously administered once weekly schedule for 4 weeks (4 times) followed by every two weeks until week 24 (10 times). A total number of administration is 14 times.
15960483|NCT03184467|Drug|GV1001 1.12 mg|GV1001 1.12 mg is subcutaneously administered once weekly schedule for 4 weeks (4 times) followed by every two weeks until week 24 (10 times). A total number of administration is 14 times.
15960484|NCT03184454|Device|Medtronic PC+S Deep Brain Stimulation|"Deep Brain stimulation involves bilateral stereotactic placement of stimulating leads into specific brain structures. Leads are attached to permanent subcutaneous wires and battery-powered implantable neurostimulators (INSs). Noninvasive INS programming can achieve a balance between maximal benefit (reduction in disabling OCD symptoms), while minimizing adverse effects (eg sensorimotor effects such as dysarthria or paresthesias; as well as behavioral side effects, e.g., hypomania, insomnia, or increased anxiety)."
15960485|NCT03184441|Device|Premie Pouch|The Premie Pouch is an experimental device meant to manage the development of Deformational Plagiocephaly (DP) starting immediately following birth. The Premie Pouch has a concave-shaped foam insert that will provide a resting surface for the infant's head and body that will eliminate uneven pressure on the infant's occiput while maintaining correct body alignment. Also, the posterior neck area of the infant will be supported by a fixed bridge section of the foam insert. The Premie Pouch is designed specifically for the very low birth weight (VLBW) infant.
15960486|NCT03184428|Other|Postoperative observation and survey|For postoperative Observation with a survey we ask the patients (or in case of no information the ophthalmologist) whether they had undergone a YAG-Laser-Capsulotomy after Cataract-Surgery or not.
15960487|NCT03184415|Drug|DWC20155|tablet
15960488|NCT03184415|Drug|DWC20156|tablet
15960489|NCT03184415|Drug|placebo of DWC20155|tablet
15960490|NCT03184415|Drug|placebo of DWC20156|tablet
15960491|NCT03184402|Drug|DWJ1252|tablet
15960492|NCT03184402|Drug|Gasmotin|tablet
15960493|NCT03184402|Drug|Placebo of Gasmotin|tablet
15960494|NCT03184402|Drug|Placebo of DWJ1252|tablet
15960495|NCT03184389|Behavioral|Prompt to use smartphone apps for stress management|Study smartphone and software will be used to deliver intervention prompts to use stress management applications on the study smartphone at various times throughout the day, during at least 10 days of study participation. The delivery of prompts will be micro randomized to occur when participants are classified as stressed, and when participants are not classified as stressed. Headspace, a commercial stress management application, will be installed on the study smartphones. Thought Shakeup and Mood Surfing, stress management applications that are not commercially available, also will be installed on the study smartphones. These smartphone applications guide participants through stress management exercises that draw upon techniques from mindfulness, cognitive behavioral therapy, and acceptance and commitment therapy.
15960496|NCT03184376|Dietary Supplement|Prebiotic oligofructose|Powder format
15960497|NCT03184376|Dietary Supplement|Placebo maltodextrin|Powder format
15960498|NCT03184363|Drug|Clostridium Botulinum A Toxin|Clostridium Botulinum A Toxin
15960499|NCT03184350|Radiation|Adjuvant pelvic proton radiation|Patients will receive a dose of 45-50.4 Gray in 1.8 Gray fractions 5-6 times per week using active raster-scanning pencil beam proton radiation
15960500|NCT03184337|Behavioral|CDC's PreventT2 Program|The PreventT2 program will involve 8 group sessions administered over 3 months. It is a behavioral intervention focused on achieving weight loss by improving nutritional intake and increasing physical activity. It will also include individual biweekly phone calls for 6 months.
15960501|NCT03184337|Behavioral|CDC's PreventT2 Program with Added Sleep Content|The CDC's PreventT2 program with added sleep content will involve 8 group sessions administered over 3 months. It is a behavioral intervention focused on achieving weight loss by improving sleep quality and nutritional intake and increasing sleep duration and physical activity. It will also include individual biweekly phone calls for 6 months.
15960502|NCT03184324|Drug|DWP14012|tablet
15960503|NCT03184324|Drug|Esomeprazole|tablet
15960504|NCT03184324|Drug|DWP14012 placebo|tablet
15960505|NCT03184324|Drug|Esomeprazole placebo|tablet
15960506|NCT03184311|Other|High-intensity interval training (HIT)|Supervised 12-week HIT 3 times per week on a bicycle ergometer.
15960507|NCT03184311|Other|Moderate-intensity contiuous training (MCT)|Supervised 12-week MCT 3 times per week on a bicycle ergometer.
15960508|NCT03184298|Other|Surveys|The purpose of the surveys is to collect quantitative data to determine the relative impact of the intervention program on participants' sexual behaviors and alcohol use.
15960509|NCT03184298|Other|Interviews|These Motivational Interviews aim to promote change in behavior through open-ended questions, affirmations, and reflections.
15960555|NCT03184155|Drug|Sterile Saline|Bolus of intracoronary sterile saline injection prior to PCI followed by an additional 2-4 doses of sterile saline depending on complexity of PCI
15960558|NCT03184142|Behavioral|Control group|No intervention. The students suture for 70 minutes
15960510|NCT03184298|Other|Group Discussions|The purpose of the group workshop is to create discussions surrounding perceived and collective social norms found among male soldiers that have been connected to sexual aggression. These discussions are used to promote bystander intervention among participants and help identify the prosocial attitudes that may be more common than previously perceived.
15960511|NCT03184285|Procedure|baseline alert 1|measurement in supine position
15960512|NCT03184285|Procedure|Anti-Trendelenburg-position (ATB)|measurement under ATB
15960513|NCT03184285|Procedure|ATB in narcosis|measurement under ATB in narcosis
15960514|NCT03184285|Procedure|baseline in narcosis 1|measurement in supine position in narcosis
15960515|NCT03184285|Procedure|passive leg raising|measurement under passive leg raising
15960516|NCT03184285|Procedure|volume bolus substitution|measurement in supine position after volume bolus (15 ml/kgKG Sterofundin balanced solution intravenous)
15960517|NCT03184285|Procedure|baseline in narcosis 2|measurement in supine position
15960518|NCT03184285|Procedure|start capnoperitoneum|measurement in supine position
15960519|NCT03184285|Procedure|ATB plus capnoperitoneum|measurement under ATB plus capnoperitoneum
15960520|NCT03184285|Procedure|ATB plus capnoperitoneum plus volume bolus substitution|measurement in ATB plus capnoperitoneum after volume bolus (15 ml/kgKG Sterofundin balanced solution intravenous)
15960521|NCT03184285|Procedure|ATB loss of capnoperitoneum|measurement under ATB
15960522|NCT03184285|Procedure|baseline|measurement in supine position
15960523|NCT03184285|Procedure|baseline alert 2|measurement in supine position
15960524|NCT03184285|Procedure|torso position rising 30° at the beginning|measurement in the recovery unit
15960525|NCT03184285|Procedure|torso position rising 30° at the end|measurement in the recovery unit
15960526|NCT03184272|Procedure|baseline alert 1|measurement in supine position
15960527|NCT03184272|Procedure|Anti-Trendelenburg-position (ATB)|measurement under ATB
15960528|NCT03184272|Procedure|ATB in narcosis|measurement under ATB in narcosis
15960529|NCT03184272|Procedure|baseline in narcosis 1|measurement in supine position in narcosis
15960530|NCT03184272|Procedure|passive leg raising|measurement under passive leg raising
15960531|NCT03184272|Procedure|volume bolus substitution|measurement in supine position after volume bolus (15 ml/kgKG Sterofundin balanced solution intravenous)
15960532|NCT03184272|Procedure|baseline in narcosis 2|measurement in supine position
15960533|NCT03184272|Procedure|start capnoperitoneum|measurement in supine position
15960534|NCT03184272|Procedure|ATB plus capnoperitoneum|measurement under ATB plus capnoperitoneum
15960535|NCT03184272|Procedure|ATB plus capnoperitoneum plus volume bolus substitution|measurement in ATB plus capnoperitoneum after volume bolus (15 ml/kgKG Sterofundin balanced solution intravenous)
15960536|NCT03184272|Procedure|ATB loss of capnoperitoneum|measurement under ATB
15960537|NCT03184272|Procedure|baseline|measurement in supine position
15960538|NCT03184272|Procedure|baseline alert 2|measurement in supine position
15960539|NCT03184272|Procedure|torso position rising 30° at the beginning|measurement in the recovery unit
15960540|NCT03184272|Procedure|torso position rising 30° at the end|measurement in the recovery unit
15960541|NCT03184259|Device|Robotic ankle system|Patients will wear the robotic ankle system and undergo 20-minute over-ground walking and 10-minute stair walking.
15960542|NCT03184259|Device|Robotic knee system|Patients will wear the robotic knee system and undergo 20-minute over-ground walking and 10-minute stair walking.
15960543|NCT03184246|Device|GlideScope|videolaryngoscopy (GlideScope) will be used for intubation
15960544|NCT03184246|Device|Direct laryngoscopy|direct laryngoscopy will be used for intubation
15960545|NCT03184233|Procedure|Rapid ventricular pacing|Rapid ventricular pacing (RVP) is a technique to obtain flow arrest for short periods of time during dissection or rupture of the aneurysm. RVP results in an adequate fall in blood pressure which presents as an on-off phenomenon. The technique facilitates the dissection and manipulation of cerebral aneurysms and arteriovenous malformations (AVMs) and can be lifesaving in the case of an intraoperative bleeding or rupture
15960546|NCT03184233|Procedure|No rapid ventricular pacing|No rapid ventricular pacing is applied perioperatively.
15960547|NCT03184220|Procedure|Physiotherapy treatment|"The MRT group was treated five times with several maneuvers. Each maneuver was performed once per session by slow and progressive application of a light force. The whole procedure lasted no more than 45 minutes. The treatment included four basic maneuvers.
~Suboccipital induction
~Posterior elongation of the cervical fascia in Supine position
~Assisted cervical fascia
~Myofascial induction of sternocleidomastoid"
15960548|NCT03184220|Procedure|Physiotherapy treatment|The PT group will treated during two weeks (ten days/week) with ultrasound therapy (US), transcutaneous electric nerve stimulation (TENS) and massage, in this order. Ultrasound will applied in pulse mode at an intensity of 1 megahertz for 10 minutes in the sub-occipital region and the vicinity of the trapezius muscles. TENS will applied with a pulse duration of 250 microseconds at a frequency of 80 Hertz for 20 minutes in the sub-occipital region and the trapezoids. Deep massage was applied at a slow speed for 20 minutes using sliding neutral creams. Massage therapy included gliding and kneading techniques applied over trapezius (upper, lower and middle fibers), splenius capitis and levator scapulae muscles with a therapeutic intention.
15960549|NCT03184194|Drug|nivolumab-daratumumab|nivolumab-daratumumab will be given without low-dose cyclophosphamide until progression
15960550|NCT03184194|Drug|nivolumab-daratumumab with low-dose cyclophosphamide|nivolumab-daratumumab with low-dose cyclophosphamide will be given until progression
15960551|NCT03184181|Other|EPTE® group|Therapeutic Percutaneous Electrolysis once week for four weeks associated with eccentric exercises devices at home.
15960552|NCT03184181|Other|Dry needling group|The intervention for this group consisted of dry needling in trigger points associated with eccentric exercises devices at home.
15960553|NCT03184168|Drug|[14C]lorlatinib|Extemporaneously compounded oral solution of [14C]lorlatinib (approximately 100 mg/100 µCi)
15960554|NCT03184155|Drug|Nicardipine|200 mcg intracoronary nicardipine injection prior to PCI followed by an additional 2-4 doses of 100 mcg intracoronary nicardipine depending on complexity of PCI
15960797|NCT03182439|Device|Tom Tom Spark Cardio|Tom Tom Spark Cardio Heart Rate Monitoring Device
15960559|NCT03184129|Device|trial group|Patients with knee disease who will undergo knee arthroplasty will be randomized into trial group. The patients from the trial group will receive newly developed knee arthroplasty with knee prostheses purchased from Wuhan Yijiabao Biomaterial Co., Ltd..
15960560|NCT03184129|Device|control group|Patients with knee disease who will undergo knee arthroplasty will be randomized into control group. The patients from the control group will receive knee arthroplasty with knee prostheses purchased from Beijing AKEC Medical Co., Ltd., Beijing, China (approved by China Food and Drug Administration).
15960561|NCT03184116|Behavioral|Individual intervention|Individual intervention based on a cognitive-behavioral program Reasoning & Rehabilitation
15960562|NCT03184103|Diagnostic Test|anti streptolysin o titre and serum complement test|diagnostic lab test
15960563|NCT03184090|Drug|Palbociclib|palbociclib in combination with endocrine therapy (investigator's choice)
15960564|NCT03184090|Drug|Endocrine therapy (non IMP)|Endocrine therapy (physician's choice based on prior administered agent including tamoxifen, exemestane, fulvestrant, anastrozole, or letrozole). Endocrine therapy must be different from previous treatment line.
15960565|NCT03184077|Procedure|Laceration Repair with Polyglactin 910|Polyglactin 910 suture for laceration repair
15960566|NCT03184077|Procedure|Laceration Repair with poliglecaprone 25|poliglecaprone 25 suture for laceration repair
15960567|NCT03184064|Dietary Supplement|Blackcurrant extract (low dose)|Participants will consume a small beverage that contains blackcurrant extract (low dose) immediately before a high-carbohydrate meal.
15960568|NCT03184064|Dietary Supplement|Placebo|Participants will consume a small beverage that contains no fruit extracts immediately before a high-carbohydrate meal.
15960569|NCT03184064|Dietary Supplement|Citrus extract (low dose)|Participants will consume a small beverage that contains citrus extract (low dose) immediately before a high-carbohydrate meal.
15960570|NCT03184064|Dietary Supplement|Blackcurrant extract (high dose)|Participants will consume a small beverage that contains blackcurrant extract (high dose) immediately before a high-carbohydrate meal.
15960571|NCT03184064|Dietary Supplement|Blackcurrant and citrus extracts (low dose / low dose)|Participants will consume a small beverage that contains blackcurrant and citrus extracts (low dose / low dose)immediately before a high-carbohydrate meal.
15960572|NCT03184038|Procedure|Cognitive Assessment|Undergo assessment of neurocognitive function of subjects with 1-4 metastases vs 5-10 metastases
15960573|NCT03184038|Radiation|Stereotactic Radiosurgery|Undergo standard of care (SRS) Stereotactic Radiosurgery
15960574|NCT03184038|Radiation|Stereotactic Body Radiation Therapy|Undergo standard of care (SBRT) Stereotactic Body Radiation Therapy
15960575|NCT03184025|Other|dentin adhesive|HEMA-containing and HEMA-free Self-Etch dentin adhesives clinical performance with or without surface sealant
15960576|NCT03184012|Device|NuSmile Zirconia crowns by NuSmile company|anterior carious teeth restored with Zirconia crowns
15960577|NCT03184012|Device|Composite resin strip crowns by 3M company|anterior carious teeth restored with Strip crowns
15960578|NCT03183999|Dietary Supplement|fermented ginseng (GINST)|Intervention group should take fermented ginseng (GINST) capsule 3 times a day, 2 capsules at one time for 12 weeks
15960579|NCT03183999|Dietary Supplement|Placebo|Control group should take placebo capsule 3 times a day, 2 capsules at one time for 12 weeks
15960580|NCT03183986|Device|Phototherapy|Phototherapy for 24 hours.
15960581|NCT03183973|Biological|PRF|patients who will receive PRF suspension
15960582|NCT03183973|Biological|placebo group|patients who will receive Placebo
15960583|NCT03183960|Behavioral|Mentor|Traditional rehabilitation.
15960584|NCT03183947|Procedure|fMRI|collection of functional brain data for 1 hour per day
15960585|NCT03183947|Behavioral|Neurofeedback|Task of the participants is to increase the activity in the selected brain region (left or right prefrontal cortex). After regulation they will get a feedback about the regulation success. (Patients: days 3 & 4; controls: Days 2 & 3)
15960586|NCT03183947|Other|PANAS|to assess the mood before and after the fMRI and after 4 weeks during a telephone interview
15960587|NCT03183947|Other|BDI-II|to assess depressive symptomatology before neurofeedback and 4 weeks after the intervention during telephone interview
15960588|NCT03183947|Other|ERQ|To assess emotion regulation strategies before and after neurofeedback training (patients: day 3&4; controls: day 2&3) and after 4 weeks during a telephone interview
15960589|NCT03183934|Biological|ALLO-ASC-DFU|"ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor(VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a Dystrophic Epidermolysis Bullosa.
~This study is a follow-up study without intervention.
~Other Names:
~Allogenic adipose-derived mesenchymal stem cells"
15960590|NCT03183921|Other|No intervention|No Interventions
15960591|NCT03183908|Biological|FLUAD®|Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
15960592|NCT03183908|Biological|Fluzone® High-Dose|Advisory Committee on Immunization Practices (ACIP) Recommended Vaccine
15960593|NCT03183895|Device|Left ventricular restoration|The AccuCinch® Ventricular Repair System, implanted in the sub-valvular space of the left ventricle, is intended to reduce significant symptomatic mitral regurgitation and reverse left ventricular remodeling due to dilated cardiomyopathy of either ischemic or non-ischemic etiology via percutaneous interventional methods.
15960594|NCT03183882|Behavioral|Personal Feedback|One-time summary report of their individual history of opioid prescribing over the past 14 months
15960595|NCT03183882|Behavioral|Peer Normative Comparison Feedback|One-time summary report of their individual history of opioid prescribing over the past 14 months WITH comparisons to (a) other providers at their site and (2) other providers at all 15 ED sites with similar prescribing
15960596|NCT03183869|Drug|Fecal microbiota|fecal microbial transplantation
15960597|NCT03183856|Device|Morning walk|a end-effector typed gait robot with a saddle
15960598|NCT03183856|Other|no Morning walk|ambulation voluntary or with a help of walker
15960599|NCT03183843|Drug|Dabigatran Etexilate|Dabigatran Etexilate 150 mg capsules for oral administration twice a day
15960600|NCT03183843|Drug|Warfarin|Warfarin 2.5 mg tablets for oral administration once a day
15960601|NCT03183830|Dietary Supplement|Nitrate-rich Beetroot Juice|The beetroot juice contains approximately 100kcal per 100mL of juice, equivalent to a glass of orange juice; the volume of juice per day for the study is 70mL. Volunteers will be informed that an average woman weighing 65kg should not consume more than 2000kcal per day, and an average man of 75kg not more than 2500kcal per day.
15960602|NCT03183830|Dietary Supplement|Nitrate-deplete Beetroot Juice|"See description of placebo juice in Arms for comparative information. The beetroot juice contains approximately 100kcal per 100mL of juice, equivalent to a glass of orange juice; the volume of juice per day for the study is 70mL. Volunteers will be informed that an average woman weighing 65kg should not consume more than 2000kcal per day, and an average man of 75kg not more than 2500kcal per day."
15960603|NCT03183817|Behavioral|Person-centred care at distance|Person-centred care at distance through an eHealth platform
15960604|NCT03183804|Biological|ALLO-ASC-DFU|Application of ALLO-ASC-DFU sheet to diabetic foot ulcer. This study is a follow-up study without intervention.
15960605|NCT03183804|Other|Standard therapy|Standard therapy conducted for patients with diabetic foot ulcer. This study is a follow-up study without intervention.
15960606|NCT03183791|Behavioral|RELAXaHEAD app|The Research Volunteers (RV) will explain the rationale for PMR and load the RELAXaHEAD app onto the patients' smartphones. The RV will review the app with the subject, focusing on user knowledge, usability, and engagement. The patient will perform a 15 minute session of PMR during the study enrollment and discuss the optimal time and place to practice PMR at home. Subjects will also be taught to enter their headache log daily on the app.
15960607|NCT03183791|Behavioral|Monitored Usual Care (MUC)|"The Research Volunteers (RV) will load the app onto the patients' smartphones but the PMR component will be blocked on the version of the app that the MUC patients receive.
~Subjects will be taught to enter their headache log daily on the app."
15960608|NCT03183778|Drug|Patiromer|Patiromer is a drug used for the treatment of hyperkalemia, a condition that may lead to palpitations and arrhythmia.
15960609|NCT03183778|Dietary Supplement|Research Diet Menu|During the study, participants will be asked to consume only the foods provided in the research diet
15960610|NCT03183765|Drug|Measles-Mumps-Rubella Vaccine|"MMR vaccine will be injected 0.5 ml into the largest wart at 2-week intervals until complete clearance was achieved or for a maximum of 3 treatments.
~Response to treatment will be evaluated 1 month after the last session by decrease in the size of warts, decrease in the number of warts and photographic comparison. The clinical response was graded into complete (complete cure), partial (if there was a decrease in the size and\or a decrease in the total number of warts), and no response (no change in size and number of warts)."
15960611|NCT03183765|Procedure|cryotherapy|"patients received cryotherapy with liquid nitrogen once every 2 weeks until complete clearance or for a maximum of 3 sessions.Response to treatment will be evaluated 1 month after the last session by decrease in the size of warts, decrease in the number of warts and photographic comparison.
~The clinical response was graded into complete (complete cure), partial (if there was a decrease in the size and\or a decrease in the total number of warts), and no response (no change in size and number of warts)."
15960612|NCT03183752|Drug|Metformin|500 mg metformin three times daily
15960613|NCT03183752|Drug|Placebo|500 mg placebo three times daily
15960614|NCT03183739|Drug|ASP8062|ASP8062 will be administered orally.
15960615|NCT03183739|Drug|Placebo|Placebo will be administered orally.
15960616|NCT03183726|Biological|ALLO-ASC-DFU|"ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor (VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide an new option in treating a diabetic foot ulcer.
~This study is a follow-up study without intervention."
15960617|NCT03183713|Behavioral|Cognitive Behavioral Therapy|Psychologically symptomatic patients will then be randomized to 4-8 weeks of placebo phone calls (Group PS-PL-Sx) or 4-8 weeks of cognitive behavior therapy treatment (PS-CBT-Sx) based on a 1:1 randomization ratio. Subjects randomized to receive CBT before surgery will proceed to 6 sessions given within 4-8 weeks by a licensed psychologist specializing in pain. CBT sessions will be 30 minutes in length, and focus on empirically supported behavior management, problem solving, cognitive restructuring, and relaxation training. The first session will be performed in person, and the subsequent 5 sessions will be performed over the phone.
15960618|NCT03183713|Behavioral|Sham Therapy|Study nurse will conduct six sessions (30 minutes/ session) over a 4-8 week time period. The first session will be performed in person, and the subsequent 5 sessions will be performed over the phone. Sham sessions will entail how to prepare for surgery and expectations for recovery, and will go over content that the treatment and control groups will receive in handout form.
15960619|NCT03183700|Device|Self sampling device|The investigators will allocate randomly the women to two different self sampling devices differing in having or not a preservative buffer
15960620|NCT03183700|Other|Cervical ThinPrep sampling|Women are inviated with a standard invitation letter to perform cervical ThinPrep sampling at the clinic on a pre-fixed date
15960621|NCT03183674|Drug|Oxytocin|Single dose oxytocin 45 minutes before the test
15960622|NCT03183674|Other|placebo|saline solution 0,9% spray nasal
15960623|NCT03183661|Biological|ALLO-ASC-CD|ALLO-ASC-CD is intravenous infusion containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells are directed to injured tissue, and reduce inflammation. Furthermore their immunomodulatory effects are significant for treating immune-related disease. Finally, ALLO-ASC-CD may provide a new option in treating a crohn's disease. This study is a follow-up study without intervention.
15960624|NCT03183648|Biological|ALLO-ASC-DFU|"ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor(VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a burn.
~This tudy is a follow-up study without intervention.
~Other Names:
~Allogenic adipose-derived mesenchymal stem cells"
15960625|NCT03183635|Procedure|Balance training|Improvement of balance ability in stroke patients
15960660|NCT03183310|Drug|Chlorpromazine|an intravenous bolus injection of Chlorpromazine will be administered . After an incubation period of 15 minutes esophageal sensitivity will be assessed by multimodal stimulation to evaluate the effect of dopamine antagonism on esophageal sensitivity
15960626|NCT03183622|Biological|ALLO-ASC-DFU|"ALLO-ASC-DFU is a hydrogel sheet containing allogenic adipose-derived mesenchymal stem cells. Adipose-derived stem cells have anti-inflammatory effect and release growth factors such as vascular endothelial growth factor(VEGF) and hepatocyte growth factor (HGF), which can enhance wound healing and regeneration of new tissue, finally may provide a new option in treating a burn.
~This tudy is a follow-up study without intervention.
~Other Names:
~Allogenic adipose-derived mesenchymal stem cells"
15960629|NCT03183596|Drug|Bupivacaine|20-60cc of 0.25% Bupivacaine
15960630|NCT03183596|Drug|Dexamethasone|2-4mg of Dexamethasone
15960631|NCT03183583|Procedure|Tissue adhesive in primary Total Hip and Total Knee arthroplasty|Use of tissue adhesive in primary Total Hip and Total Knee arthroplasty
15960632|NCT03183570|Drug|[18F]FP-R01-MG-F2|7mCi (range 6-9mCi) [18F]FP-R01-MG-F2 will be administered
15960633|NCT03183557|Drug|"Zoledronic acid, Reclast®"|To examine the efficacy of zoledronic acid in osteoporosis
15960634|NCT03183557|Drug|"Zoledronic acid, Reclast® and active vitamin D, alfacalcidol®"|To examine the efficacy of zoledronic acid plus alfacalcidol in osteoporosis
15960635|NCT03183544|Combination Product|Gallium-68 PSMA-11 prepared using PSMA-11 Sterile Cold Kit|The patients will receive a single injection of Gallium-68 PSMA-11 to diagnose biochemical relapse of prostate cancer after treatment.
15960636|NCT03183531|Diagnostic Test|C reactive protein|Addition of C-reactive protein test for management strategies to follow-up febrile neonates in outpatient.
15960637|NCT03183518|Other|Facial micellar cleanser|Each participant will have the test product applied topically via semi occlusive patch, on-site by a technician.
15960638|NCT03183518|Other|Saline Solution: Sodium Chloride (NaCl; 0.9%)|Each participant will have the reference product applied topically via semi occlusive patch, on-site by a technician.
15960639|NCT03183505|Drug|Anyu Peibo|Anyu Peibo Capsule, 0.8g twice per day, oral after breakfast and supper
15960640|NCT03183505|Drug|Placebo|Placebo Capsule, twice per day, oral after breakfast and supper
15960641|NCT03183492|Biological|Havrix®|One challenge dose of Havrix® administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
15960642|NCT03183479|Drug|Fibrinogen Concentrate Human|After start of surgery when all pedicle screws are placed, the patients in treatment group will receive fibrinogen concentrate 30mg kg-1. For safety concern, functional fibrinogen will be measured and the maximum fibrinogen concentrate administration for each individual shall not exceed 2g. Fibrinogen concentrate will be diluted in 100mL of sterile water and then be administered to patients.
15960643|NCT03183479|Drug|Normal saline|100mL normal saline will be administered to patients in control group as placebo
15960644|NCT03183466|Procedure|arthroscopic repair|
15960645|NCT03183466|Procedure|arthroscopic debridement|
15960646|NCT03183453|Behavioral|Neuropsychological treatment|Participants had to learn some brief material (words, faces, pictures, news), after which they were asked for an immediate and a delayed recall. After both recalls, participants were confronted with feedback about correct responses, non-responses and errors (i.e., confabulations and errors of attribution). This type of feedback worked on: 1) selective attention during the learning phase, training patients to focus on the relevant details of the stimuli; 2) monitoring processes during the retrieval phase, reinforcing the strategic search and training patients to inhibit traces that were irrelevant; and 3) memory control processes after the retrieval phase. The treatment consisted of 9 sessions and lasted for 3 weeks and the participants performed a baseline before and after treatment.
15960647|NCT03183440|Dietary Supplement|PREBIOTICS|women will daily take a mixture of Galacto-Oligo-Saccharide/inulin (ratio 9:1) from inclusion to delivery
15960648|NCT03183440|Other|PLACEBO|women will daily take placebo (maltodextrin) from inclusion to delivery
15960649|NCT03183427|Diagnostic Test|MR of the brain|MR of the brain without gadolinium, incl. T2-weighted image
15960650|NCT03183414|Other|echocardiographic measurements|echocardiographic parameters of the RV, measured with TEE and the right ventricular ejection fraction (thermodilution)
15960651|NCT03183388|Behavioral|BE-SMART|Participants will take part in 12 therapy sessions, at a rate of about 1 session every one to two weeks. Sessions are anticipated to last about 1 hour each. Sessions may be focused on teaching skills to regulate emotions or regularize sleep and activity. These therapy sessions may be videotaped and audiotaped (only with the expressed written consent of the participant, and when appropriate, the participant's parent or guardian). Participants will be asked to complete worksheets and practice the skills learned from these sessions and will be asked questions about feelings. There will be an interview, assessments and scanning performed prior to treatment and at the midpoint and end to assess progress. The intervening 9 sessions may be by video telecommunication. Participants may be given devices to track actigraphy and ecological momentary assessments.
15960652|NCT03183375|Drug|Hydroxyurea|Hydroxyurea (starting from 10mg/kg/day with increasing dose by 2mg/kg/day until the desired response is achieved. The maximum dose given will be 20mg/kg/day)
15960653|NCT03183362|Device|Barbed suture ( STRATAFIX™ )|Cesarean section incision will be closed using a 24-cm × 24-cm 0 polydioxanone double-armed suture on a 26-mm half-circle reverse cutting needle( STRATAFIX™ Spiral PDO Knotless Tissue Control Device, Ethicon Inc , Somerville, NJ, USA ).Patients who will return for a repeat caesarean (elective or emergency) will be evaluated intraoperatively for the presence of adhesions between various pelvic structures.
15960654|NCT03183362|Device|Conventional suture (VICRYL™)|Cesarean section incision will be closed using 1-0 polyglactin 910 suture(VICRYL™.; Ethicon Inc, Sommerville, NJ) .Patients who will return for a repeat caesarean (elective or emergency) will be evaluated intraoperatively for the presence of adhesions between various pelvic structures .
15960655|NCT03183349|Procedure|deprotienized bovine bone (tutogen)|
15960656|NCT03183349|Procedure|platelet rich fibrin|
15960657|NCT03183336|Procedure|ridge split interpositional block graft|
15960658|NCT03183336|Procedure|decortication Onlay block graft|
15960659|NCT03183323|Behavioral|Telerehabilitation|Activity trackers. Mio Slice is worn through the whole study. Actigraph is worn for one week, at 4 different timepoints through the study.
15960798|NCT03182439|Device|Apple Watch|Apple Watch Heart Rate Monitoring Device
15960799|NCT03182426|Drug|Plerixafor|Systemic CD34+ stem cell mobilization for beta-cell repair
15960661|NCT03183310|Device|Multimodal stimulation probe|The multimodal esophageal probe allows to perform 4 types of stimulations in the esophagus (thermal, mechanical, electrical and chemical stimulation). These 4 modalities will be evaluated to assess esophageal sensitivity.
15960662|NCT03183310|Drug|Placebo - Concentrate|an intravenous bolus injection of saline (NaCl 0.9%) will be administered . After an incubation period of 15 minutes esophageal sensitivity will be assessed by multimodal stimulation.
15960663|NCT03183297|Drug|JMI-001|JMI-001, a combination product of naproxen and fexofenadine
15960664|NCT03183297|Drug|Naproxen|Naproxen sodium 220mg
15960665|NCT03183297|Drug|Fexofenadine|Fexofenadine 60mg
15960666|NCT03183297|Drug|placebo|placebo comparator
15960667|NCT03183271|Radiation|external beam proton radiation therapy.|Treatment of irradiation with protons beam The patients will be enrolled either at the Centro Nazionale di Adroterapia Oncologica (CNAO), Pavia, Italy, or at referral Hospitals enrolling head and neck patients for treatment with photon IMRT.
15960668|NCT03183258|Other|Sentinel skin flap|Donor-derived vascularised composite allograft (sentinel skin flap)
15960669|NCT03183245|Biological|Human Acellular Vessel (HAV)|Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access.
15960670|NCT03183245|Procedure|Arteriovenous fistula (AVF)|Surgical creation of an autologous arteriovenous fistula and subsequent use of the implanted vascular conduit for hemodialysis vascular access.
15960671|NCT03183232|Procedure|Cryosurgery or IRE surgery|Cryosurgery or IRE surgery will be used in local tumor
15960672|NCT03183232|Biological|γδ T cell|γδ T cells will be used against Lung Cancer
15960673|NCT03183232|Other|γδ T cells/ A Cryosurgery or IRE|Combination γδ T cell and Cryosurgery or IRE surgery will be used in Lung Cancer
15960674|NCT03183219|Procedure|Cryosurgery or IRE surgery|Cryosurgery or IRE surgery will be used in local tumor
15960675|NCT03183219|Biological|γδ T cell|γδ T cells will be used against Liver Cancer
15960676|NCT03183219|Other|γδ T cells/ A Cryosurgery or IRE|Combination γδ T cell and Cryosurgery or IRE surgery will be used in Liver Cancer
15960677|NCT03183206|Procedure|Cryosurgery , IRE surgery ,surgery|surgery will be used in local tumor
15960678|NCT03183206|Biological|γδ T cells|γδ T cells will be used against
15960679|NCT03183206|Other|γδ T cells/ Surgery|Combination γδ T cell and Cryosurgery, IRE surgery or surgery will be used in Breast Cancer
15960680|NCT03183193|Other|Control diet|The participants follow a conventional and balanced distribution of macronutrients (30% fat, 15% protein, 55% carbohydrates), adequate fiber (25-30 g/day) and dietary cholesterol (<250 mg/day) intake according to AHA guidelines. This strategy was included within a personalized energy-restricted diet (-30% individual needs) under healthy lifestyle advice in order to achieve the objectives of AASLD (loss of at least 3-5% of the initial body weight and up to 10% needed to improve necroinflammation).
15960681|NCT03183193|Other|FLiO diet|The participants follow a strategy based on a distribution of macronutrients 30-35% lipid (extra virgin olive oil and fatty acids Ω3 in detriment of saturated, trans and cholesterol)/ protein 25% (vegetable against animal)/carbohydrates 40-45% (low glycaemic index, fiber 30-35 g/day); high adherence to the Mediterranean diet and natural antioxidants; meal frequency of 7 meals/day; size/composition of the ration suitable for each moment; including traditional foods with no additional economic cost that will allow diet adherence without abandonment; avoid inappropriate mealtimes and the eating manners as the eating rate. The participants are instructed to follow this strategy within a personalized energy-restricted diet (-30%) and under healthy lifestyle advice to achieve AASLD objectives.
15960682|NCT03183180|Diagnostic Test|Echocardiogram|Current cardiac state will be assessed by an experienced cardiologist, including a full new Echocardiogram examination
15960683|NCT03183167|Other|No intervention|
15960684|NCT03183154|Other|no intervention|no intervention
15960685|NCT03183141|Biological|SER-109|SER-109, an oral, biologically derived, live microbiome therapeutic that comprises purified bacterial spores
15960686|NCT03183128|Biological|SER-109|"SER-109 is an ecology of bacteria in spore form, enriched from stool donations obtained from healthy, screened donors
~Other Names:
~Eubacterial Spores, Purified Suspension, Encapsulated"
15960687|NCT03183128|Drug|Placebo|Placebo will be identical to the investigational product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline(0.9%).
15960688|NCT03183115|Procedure|Radiofrequency ablation|HALO360 System (Covidien GI Solutions, Sunnyvale, California, USA), which has been approved by the US Food and Drug Administration (FDA) and is approved for use in Europe (CE mark) and Taiwan (Ministry of Health and Welfare).
15960689|NCT03183115|Device|Endoscopy|The participants will receive meticulous endoscopic examination with Lugol chromoendoscopy and Narrow-band imaging
15960690|NCT03183115|Drug|Lugol's Solution (1.5%)|Before the RFA intervention, the participants will received Lugol staining over the esophagus
15960691|NCT03183102|Dietary Supplement|Flaxseed|2 months of dietary flaxseed supplementation
15960692|NCT03183089|Drug|Rohto Dry-Aid®|
15960693|NCT03183089|Drug|Systane® Ultra|
15960694|NCT03183076|Other|modified adkins diet|Patients were assigned to two groups, one of them received modified adkins diet for treatment of drug-resistant epilepsy. It consists in the free intake of proteins and fats, and the restriction of carbohydrates that are gradually being installed. Its mechanism of action that induces a state of ketosis
15960695|NCT03183076|Drug|Pharmacotherapy without diet|Patients were assigned to two groups, one of them received conventional treatment with antiepileptic drugs without a special diet
15960696|NCT03183063|Device|4DCT and SPECT/CT|Each patient will receive two 4DCT followed by SPECT/CT.
15960697|NCT03183063|Device|4DCT with BiPAP and SPECT/CT|Each patient will receive two 4DCT, with the second scan obtained with positive pressure breathing via BiPAP, followed by SPECT/CT
15960698|NCT03183063|Device|4DCT with CTA in suspected PE|Each patient will receive 4DCT before or after CTA for suspected PE
15960699|NCT03183050|Behavioral|Question Prompt List|Patients receive a booklet that contains questions regarding their diagnosis, testing and treatment.
15960772|NCT03182621|Behavioral|THINK|The THINK curriculum was based on the principles of exercise physiology and health behaviors. Sessions included educational components, concentrating on physiology, nutrition, laboratory experiences, and structured physical fitness activities.
15960700|NCT03183037|Procedure|Acupuncture|The acupuncture group will undergo 8 weeks of outpatient acupuncture or sham acupuncture treatments (twice weekly for 2 weeks, then weekly for 6 weeks, 10 treatments in total). The investigators have designed this approach to standardize acupuncture treatment for future broad use; it is based on the understanding that CIPN is a global symptom complex rather than individual isolated or local symptoms.
15960701|NCT03183037|Procedure|Sham Acupuncture|Subjects in this group will receive the sham acupuncture procedure on the same schedule as subjects in the real acupuncture group. In both groups, patients' eyes will be covered with patches so they cannot observe the treatment procedure. To improve incentive to join and stay in the study, we will unblind all patients at Week 12, and offer those randomized to the Sham group 8 weeks of Acu (real) treatment. All points used will be documented.
15960702|NCT03183037|Other|Usual Care Group|Patients go to clinic three times during the study, at Baseline, Week 8, and Week 12 to undergo QST and CPM tests. Patients will complete all questionnaires (CIPN severity by 0-10 11-point numeric rating scale, FACT/GOG-Ntx-11, NPS) and their pain medication use at these time points. Week 4 questionnaires can be completed over the phone. As an incentive for patients to join the study - and for those randomized to control to stay in the study - controls will be offered 8 weeks of Acu (real) treatment once they have completed Week 12 assessments.
15960703|NCT03183037|Behavioral|questionnaires|FACT/GOG-Ntx, Neuropathic Pain Scale (NPS),Treatment Expectancy Scale (TES), Quantitative Sensory Testing (QST), Insomnia Severity Index (ISI), Hospital Anxiety and Depression Scale (HADS), Brief Fatigue Inventory (BFI)
15960704|NCT03183024|Biological|benralizumab|open-label treatment
15960705|NCT03183024|Biological|placebo|sterile water to mimic benralizumab
15960706|NCT03183011|Other|MRI|Cardiac MRI
15960707|NCT03182998|Other|Internet-Based Intervention|"Receive Knowing your Options decision aid"
15960708|NCT03182998|Other|Internet-Based Intervention|"Receive Prostate Choice decision aid"
15960709|NCT03182998|Other|Best Practice|Undergo usual care
15960710|NCT03182998|Other|Quality-of-Life Assessment|Ancillary studies
15960711|NCT03182998|Other|Questionnaire Administration|Ancillary studies
15960712|NCT03182998|Other|Survey Administration|Ancillary studies
15960713|NCT03182998|Other|Laboratory Biomarker Analysis|Correlative studies
15960714|NCT03182985|Behavioral|Time Restricted Feeding|Participants will reduce the amount of time they eat to 10 hours per day and will log their dietary intake using a smartphone application.
15960715|NCT03182972|Other|Medication reconciliation|Pre-post intervention
15960716|NCT03182959|Drug|Avmacol®|Avmacol® tablets
15960717|NCT03182946|Diagnostic Test|Platelet mapping Thromboelastography|These diagnostic tests will be acquired in patients with brain injury, to determine prediction of clinical, functional and psychological outcome.
15960718|NCT03182933|Drug|Peripheral Nerve Blockade|Each study arm will receive their respective formulation of local anesthetic, either standard bupivacaine or liposomal bupivacaine upon randomization
15960719|NCT03182933|Behavioral|10 meter walk test on post-operative day 1|Patient asked to walk 10 meters at comfortable pace on post-operative day one when deemed safe to do so by the physical therapist
15960720|NCT03182933|Other|In person and over the phone questionnaire|Presuming the patient has left the hospital each patient will be called on post-operative day 2, 3 to assess nausea, opioid consumption, satisfaction with anesthesia technique, nausea and vomiting as well as pain scores
15960721|NCT03182933|Device|Force transduction of quadriceps strength|Patient will be asked to flex quadriceps at maximal ability and a transducer (Kiio device) will record a force value pre operatively and on post operative day 1
15960722|NCT03182920|Drug|Lasmiditan|Oral administration
15960723|NCT03182920|Drug|Placebo|Oral administration
15960726|NCT03182894|Drug|Epacadostat (INCB024360) in Combination with Pembrolizumab (MK-3475) and Azacitidine (VIDAZA)|Oral Epacadostat (INCB024360) (50, 100, or 300 mg twice per day,on days 1-21 of each cycle, every 21 days) in combination with Pembrolizumab (MK-3475) (200 mg IV on days 1 of each cycle, every 21 days) and Azacitidine (VIDAZA) (100 mg SQ daily on days 1-5 of each cycle, every 21 days)
15960727|NCT03182881|Other|Lymphatic Drainage|It was applied with the patient in a supine position with 30º elevation of the arm and very superficial and smooth maneuvers were performed in the axillary lymph nodes, the chest region and the arm.
15960728|NCT03182881|Other|Myofascial Release|For the use of the treatment the bases of Pilat, A. 2016 were followed. The global and specific techniques for the periganglionar and upper thoracic region were chosen. The application of each smooth maneuver three-dimensional fascial movement has been carried out has an approximate duration of about 10 minutes and a total of 50 minutes.
15960729|NCT03182868|Device|PAS Goggle|PAS goggle is a self-contained stimulus and sensing device that is designed to deliver the visual stimuli currently delivered via light projected on a wall while simultaneously recording the movement of the eyes. Each vestibular testing session last about 15 minutes.
15960730|NCT03182855|Drug|Ticagrelor|ADP-receptor blocker. Oral formulation. Standard Therapy in Acute Myocardial Infarction. Administered in the ambulance in arm 1 and in the hospital (catheterization laboratory) in arm 2.
15960731|NCT03182855|Drug|Cangrelor Tetrasodium|Intravenous ADP-receptor blocker. Administered after hospital arrival in the catheterization laboratory.
15960732|NCT03182842|Device|FreeStyle Libre FGM|Insulin dosing based on FreeStyle Libre FGM system that is indicated for measuring interstitial fluid glucose levels in people (age 4 and older) with diabetes mellitus.
15960733|NCT03182842|Device|SMBG - Blinded Sensor|Insulin dosing based on SMBG
15960734|NCT03182829|Diagnostic Test|DOAC Dipstick|"Patients collect a sample of urine for analysis.
~publication Thromb Haemost. 2019 Nov 8. doi: 10.1055/s-0039-1700545. [Epub ahead of print]"
15960773|NCT03182621|Behavioral|SPARK|traditional YMCA program
15960774|NCT03182608|Diagnostic Test|Noninvasive ultrasound assessment|An investigator evaluate the L4-5 interspinous level using anatomic landmarks in turn, then another independent investigator assess the consistency of the landmarks-guided interspinous level with the actual one by noninvasive ultrasound assessment.
15960735|NCT03182816|Biological|anti-CTLA-4/PD-1 expressing EGFR-CAR-T|Every cycle, peripheral blood mononuclear cells (PBMC) are collected on day 0, CAR-T cells are cultured in a GMP standard workshop. Patients are given a three-day regimen of chemotherapy consisting of cyclophosphamide aimed to deplete the lymphocytes before cells infusion. Then the patients will receive an i.v.gtt infusion of CTLA-4 and PD-1 antibodies expressing EGFR-CAR-T cells at (2-5) ×10^7 cells/kg from day 18 to day 19 (±2 days). 2 cycles are regarded as a treatment period.
15960736|NCT03182803|Biological|CTLA-4/PD-1 antibodies expressing mesoCAR-T|Every cycle, peripheral blood mononuclear cells (PBMC) are collected on day 0, CAR-T cells are cultured in a GMP standard workshop. Patients are given a three-day regimen of chemotherapy consisting of cyclophosphamide aimed to deplete the lymphocytes before cells infusion. Then the patients will receive an i.v.gtt infusion of CTLA-4 and PD-1 antibodies expressing mesothelin-targeted CAR-T cells at (2-5) ×10^7 cells/kg from day 18 to day 19 (±2 days). 2 cycles are regarded as a treatment period.
15960737|NCT03182790|Behavioral|Instant Messaging IM|Smokers can communicate with counsellors in real-time through instant messaging (social media). Our counsellors will trigger the conversation and invite the smokers to response after initial contact. Counsellors will keep contact with the smokers to offer help, positive encouragement, reflections and reminders about SC according to smokers' personal needs and to encourage them to seek SC services. Details of successfully booked SC appointment (e.g. SC services address, contact information, date, appointment number etc.) will be delivered to the smokers using IM. All smokers will receive a reminder-to-attend IM messages 1-3 days before the appointment date.
15960738|NCT03182790|Behavioral|Regular messages|Regular messages, including: harm of smoking, benefit of smoking cessation, importance of adherence to smoking cessation appointment and encouragement on abstinence will be sent to smokers after initial contact via social media.
15960739|NCT03182790|Behavioral|AWARD advice|Ask about smoking history, Warn about the high risk of smoking, Advise to quit as soon as possible, Refer to the smoking cessation services, and Do it again (if the smokers refused to set quit date).
15960740|NCT03182790|Behavioral|Referral card|"The 3-folded Smoking Cessation Services card consists of brief information and highlights of existing smoking cessation services, contact methods, motivation information and strong supporting messages or slogans"
15960741|NCT03182790|Behavioral|Brief advice|Very brief, minimal and general smoking cessation advice
15960742|NCT03182790|Behavioral|COSH booklet|A general smoking cessation self-help booklet
15960743|NCT03182790|Behavioral|Placebo Messages|Placebo messages will be sent via smart phones (e.g. social media) to remind subjects to take follow-up calls before each follow-up time points.
15960744|NCT03182790|Behavioral|Warning Leaflet|The leaflet will include the information about the health risks of smoking.
15960745|NCT03182777|Procedure|Dental restorative procedure|Infiltration of two cartridges (3.6 mL) of local anesthetics with 2% lidocaine with or without epinephrine 1:100,000, in two sessions with an interval of seven days between them, in oral mucosa in patients with cardiac channelopathies.
15960746|NCT03182764|Other|No intervention|No intervention
15960747|NCT03182751|Drug|Tranexamic Acid (TXA)|The cohort of patients treated with early administration of TXA in the Emergency Department will be compared to a control group who were not treated with TXA at any point.
15960748|NCT03182751|Drug|Placebo|The cohort of patients treated with a placebo in the Emergency Department will be compared to the active comparator group that will receive early administration of Tranexamic Acid.
15960749|NCT03182738|Behavioral|VIP app without HIV-related symptom strategies.|The control group will receive the VIP app without HIV-related symptom strategies
15960750|NCT03182738|Behavioral|VIP app that delivers HIV-related symptom strategies.|The Intervention group will receive the VIP app that delivers HIV-related symptom strategies
15960751|NCT03182725|Drug|Ivabradine|Ivabradine is prescribed for treatment of chronic heart failure through inhibition of the f-channels (If) within the sinoatrial node.
15960752|NCT03182725|Drug|Placebo|A substance that has no therapeutic effect and will act as a control.
15960753|NCT03182712|Dietary Supplement|n-3 PUFA Group|Participants received n-3 PUFA capsules (capsules containing 180 mg of eicosapentaenoic acid, 120 mg of docosahexaenoic acid and 2 mg of vitamin E). Three capsules were ingested daily for eight weeks, distributed between breakfast, lunch and dinner.
15960754|NCT03182712|Dietary Supplement|Placebo Group|Participants received capsules containing 500 mg of gelatin.Three capsules were ingested daily for eight weeks, distributed between breakfast, lunch and dinner.
15960755|NCT03182699|Diagnostic Test|cardiac MRI|non contrast heart MRI at baseline and after 1 year of therapy
15960756|NCT03182699|Diagnostic Test|echocardiography with strain|echocardiography at baseline and after 1 year of therapy
15960757|NCT03182699|Diagnostic Test|Laboratory tests|drawing blood from dialysis machine
15960758|NCT03182699|Diagnostic Test|Body composition monitoring|Measurement with BCM (Fresenius) machine
15960759|NCT03182699|Diagnostic Test|lung ultrasound|ultrasound
15960760|NCT03182686|Biological|Ampion|Ampion (<5 kilodalton (kDa) ultrafiltrate of 5% HSA)
15960761|NCT03182686|Other|Saline|0.9% sodium chloride
15960762|NCT03182673|Drug|SHR7390|SHR7390 is provided as white, film-coated,immediate release tablets containing SHR7390 at dosage strengths of 0.125 mg,0.5 mg and 2mg. Multiple tablets of SHR7390 will be administered orally to achieve targeted doses of SHR7390: 0.125 mg-4 mg. Tablets will be administered once daily or for 21 days and discontinued for 7 days with 240 ml water after 2 hours of the meal.
15960763|NCT03182673|Biological|SHR-1210|SHR-1210 is a humanized anti-PD1 immunoglobulin G4 (IgG4) monoclonal antibody. SHR-1210 is provided as the lyophilized powder,200 mg/vial.SHR-1210 was given with 200mg fixed dose intravenously per 2 weeks at the D1 and D15.Intravenous infusion over 30 min
15960764|NCT03182673|Drug|SHR3162|SHR3162 is provided as capsules containing SHR3162 at dosage strengths of 10mg,40mg and 100mg. The capsule of SHR3162 will be orally administered with 240ml water twice a day to achieve targeted doses of SHR3162 and the interval of SHR3162 capsules taken twice a day is about 12 hours.
15960765|NCT03182647|Procedure|Surgically treatment of the ACL|Surgical initial ACL treatment
15960766|NCT03182647|Other|Non surgical initial ACL treatment|Non surgical initial ACL treatment
15960767|NCT03182634|Drug|Fulvestrant|
15960768|NCT03182634|Drug|Neratinib|
15960769|NCT03182634|Drug|AZD5363|
15960770|NCT03182634|Drug|Olaparib|
15960771|NCT03182634|Drug|AZD6738|
15960775|NCT03182595|Drug|Paracetamol|Volunteers will be screened at visit 1, and if they meet the inclusion/exclusion criteria they will receive the intervention at visit 2. At visit 2, complying subjects will receive a tablet containing 1 gram of paracetamol and have a blood sample collected 2 hours after administration; these procedures will be repeated on 2 more occasions (visits 3 and 4). The subjects will come for 5 visits during the study. Visit 1 and 2 must occur within 7 days of each other, visits 2, 3 and 4 will be four weeks (± 3 days) apart and visit 5 scheduled four weeks (± 3 days) after visit 4.
15960776|NCT03182582|Device|Erbium:Yttrium-Aluminum-Garnet (Er:YAG) Laser Debridement|Laser debridement entailed usage of an Er:YAG laser, employing the JOULE® machine (Sciton, Inc., Palo Alto, California). Full-field ablation was performed using the 2940 nm Er:YAG Contour TRL Resurfacing® application with the following settings: fluence - 50 J/cm2, spot overlap - 50%, pattern repeat - 0.5 seconds, spot size - 3-mm (Figure 1). Debridement was carried out until all fibrinous and/or necrotic tissues were removed, and healthy, bleeding tissue was visualized.
15960777|NCT03182582|Procedure|Scalpel/Curette Debridement|Using a scalpel/curette, each patient's chronic wound is debrided until healthy, viable tissue is noted.
15960778|NCT03182569|Device|FLEXIBLE CATHETER|
15960779|NCT03182569|Device|hourly rigid needle puncture|
15960780|NCT03182556|Behavioral|Electromyography-Biofeedback (EMG-BFB) training|The Chattanooga Intelect Advanced model was used with the surface EMG for 2 independent channels. The patient can observe on the screen as columns of varying their height in the function of the degree of muscular tension. Each session was configured as follows. First, a 2 minute period for adaptation and then we continue with a 2 minute period to establish the baseline. After that, a 7 minute training trial session to reduce the muscle tension as well as a pause of about 2 minutes. Then, it continued with two more trials of 7 minutes interleaved with another 2 minute break. Thus, the whole training lasts 29 minutes approximately. The pauses between the individual trials were intended to recover the baseline level to carry out a new trial which will start from a higher level of EMG.
15960781|NCT03182556|Behavioral|Aquatic exercise|Aquatic Exercise program (Biodanza exercises) was carried out in a swimming-pool with a water temperature of approximately 29 ° C, preceded by a shower at a temperature of about 33-35 °C. Each session lasts an hour and they will held twice a week (Monday and Wednesday) during a period of time of three months (12 weeks).
15960782|NCT03182543|Dietary Supplement|Mango pulp beverage|"The subject consumes mango pulp beverage (200 g mango pulp + 600 mL water). 2 hours later subject performs the exercise test.
~Washout: 1 week washout period prior to the administration of this intervention to avoid possible carryover effect."
15960783|NCT03182543|Dietary Supplement|Mango pulp and peel beverage|"The subject consumes mango pulp and peel beverage (160 g mango pulp + 40 g mango peel + 600 mL water). 2 hours later subject performs the exercise test.
~Washout: 1 week washout period prior to the administration of this intervention to avoid possible carryover effect."
15960784|NCT03182543|Dietary Supplement|Control beverage|"The subject consumes control beverage (600 mL water). 2 hours later subject performs the exercise test.
~Washout: 1 week washout period prior to the administration of this intervention to avoid possible carryover effect."
15960785|NCT03182530|Device|ulnar artery compression device|a radial compression device will be applied at the access site. another closure device will be used for ipsilateral ulnar artery compression for 1-hour duration in order to increase peak velocity blood flow into the radi¬al artery. neither pulse oxymetry nor duplex ultrasonography will be performed in case of ulnar artery compression. after ulnar artery compression, the initial compression of the radial artery will be reduced by letting up the pressure until bleeding will be seen and then adding minimal pressure whenever needed in order to maintain radial artery patency.
15960786|NCT03182530|Device|radial artery compression device guided with plysthmography|a radial compression device will be applied at the access site. A pulse oximeter sensor was placed over the index finger. Transient ipsilateral ulnar artery will be occluded manually to evaluate the status of radial artery patency by plethysmography (digital pulse analysis), and if there's lack of signal, the process of deflation and reinflation of the radial artery device's bladder will be repeated over the next 15 min to attempt re-establishment of antegrade radial artery flow without affecting hemostasis
15960787|NCT03182530|Device|radial artery compression device|patients undergo the conventional hemostasis compression by using a radial compression device applied at the access site.
15960788|NCT03182504|Drug|nacubactam|Participants will receive a single 2000 milligram (mg) intravenous (IV) infusion of nacubactam over 1.5 hours.
15960789|NCT03182504|Drug|meropenem|Participants will receive a single 2000 mg IV infusion of meropenem over 1.5 hours.
15960790|NCT03182491|Diagnostic Test|Biomarkers (platelet activating factor [PAF], anaphylatoxins) and basophil activation test (BAT)|Analysis of biomarkers and basophil activation test
15960791|NCT03182478|Behavioral|Rothbaum protocol in individual format|8-week 45 minute session Rothbaum CBT protocol adapted to Skin Picking, changing the focus on pulling hair to picking skin. Session 1: psychoeducation of the skin picking habit and how CBT works, patients initiate the self-monitoring of the habit. Session 2: techniques of habit reverse, adapted by having the skin as a target instead of the hair. The session 3: anxiety management using diaphragmatic breathing and muscle relaxation. Sessions 4 to 6: management of dysfunctional thoughts, using cognitive tools as the evidence analysis, reattribution of roles and gravity scale. Session 7: change of roles and role-playing, with patient playing the role of therapist, applying the Rothbaum Protocol to treat Skin Picking, so reviewing all the protocol techniques. Session 8: relapse prevention.
15960792|NCT03182478|Behavioral|Rothbaum protocol in group format|8-week 90 minute session of Rothbaum CBT protocol adapted to Skin Picking, changing the focus on pulling hair to picking skin. Session 1: psychoeducation of the skin picking habit and how CBT works, patients initiate the self-monitoring of the habit. Session 2: techniques of habit reverse, adapted by having the skin as a target instead of the hair. The session 3: anxiety management using diaphragmatic breathing and muscle relaxation. Sessions 4 to 6: management of dysfunctional thoughts, using cognitive tools as the evidence analysis, reattribution of roles and gravity scale. Session 7: change of roles and role-playing, with patient playing the role of therapist, applying the Rothbaum Protocol to treat Skin Picking, so reviewing all the protocol techniques. Session 8: relapse prevention.
15960793|NCT03182465|Diagnostic Test|Value of ProCalcitonin|The predictive value of ProCalcitonin in patients with solid tumors presenting a febrile neutropenia due to chemotherapy at emergency unit will be a factor to detect the level of bacteria.
15960794|NCT03182452|Other|Alarm Advisor|Providing advice on alarm limits as part of routine medical care
15960807|NCT03182400|Behavioral|Neurophysiological assessment|Assessment of cerebral electrical activity Assessment of ocular exploration Neurovegetative assessments
15960808|NCT03182400|Behavioral|Neuropsychological assessment|sub-tests, scales, surveys, reaction time measurement
15960809|NCT03182374|Device|nSTRIDE APS|Intra-articular injection
15960810|NCT03182374|Device|Synvisc-One|Intra-articular injection
15960811|NCT03182361|Device|Implantation of BioComp Industries cranio-maxillo-facial (CMF) screw implants|Placement of BioComp Industries extraoral screw implants with diameters 3.4mm or 4mm and lengths 3.4mm or 4mm in temporal, nasal or orbital bone
15960812|NCT03182348|Procedure|Optical coherence tomography|As part of the clinical angioplasty procedure the patient will have a coronary guidewire passed down the artery usually from the groin to the heart which is used to position balloons and stents. OCT passes over the wire in the same way. From the patients perspective the procedure may take a small amount of additional time - maximum 10-15 minutes. We would like to be able to pass a second wire down the same coronary artery called a 'buddy wire' which is sometimes required in coronary procedures. This would be used to inflate a balloon at low pressure near the area of interest in the heart in order either to exclude blood or to oppose the OCT catheter to the vessel wall if required.
15960813|NCT03182335|Other|sedation awakening trial|vital signs and delirium assessment (CAM-ICU) at baseline then following routine sedation awakening trial. Patient will thus serve as their own control for these interventions
15960814|NCT03182322|Drug|intranasal insulin|Total of 6 months treatment; daily for the first 7 intervention days and one day per week thereafter (formulation containing rH-insulin, benzalkonium chloride, glycerol and water)
15960815|NCT03182322|Other|Placebo|Total of 6 months treatment; daily for the first 7 intervention days and one day per week thereafter placebo (formulation containing benzalkonium chloride, glycerol and water)
15960816|NCT03182296|Radiation|68Ga-NODAGA-exendin-4 PET/CT|68Ga-NODAGA-exendin-4 PET/CT
15960817|NCT03182283|Behavioral|Person-centered psychosis care|Person-centered care educational intervention for staff with following implementation of person-centered care in the clinic
15960818|NCT03182270|Diagnostic Test|nCLE|Procedure: EUS-FNA Device: nCLE
15960819|NCT03182257|Drug|ONO-7579|ONO-7579 Tablets
15960824|NCT03182231|Radiation|68Ga-NODAGA-exendin-4 PET/CT|68Ga-NODAGA-exendin-4 PET/CT
15960825|NCT03182218|Drug|Direct oral anticoagulant|Time of direct oral anticoagulant withdrawal Use or not of bridging with low molecular weight heparin
15960826|NCT03182205|Other|IME|The IME session protocol will consist of 8 sets of 2 minutes with 1 minute rest between sets. Inspiratory load will be set at 40% of maximum static inspiratory pressure. In addition, the volunteer will be instructed to perform diaphragmatic breathing, maintaining a respiratory rate in the range of 12 to 15 ipm (feedback from the evaluator) and the entire exercise protocol will be performed with the patient sitting with their feet flat on the floor and using a clip nasal.
15960827|NCT03182205|Other|Sham IME|The Sham IME session protocol will consist of 8 sets of 2 minutes with 1 minute rest between sets, but without a load generating resistance. In addition, the volunteer will be instructed to perform diaphragmatic breathing, maintaining a respiratory rate in the range of 12 to 15 ipm (feedback from the evaluator) and the entire exercise protocol will be performed with the patient sitting with their feet flat on the floor and using a nasal clip.
15960828|NCT03182192|Radiation|68Ga-NODAGA-exendin-4 PET/CT|68Ga-NODAGA-exendin-4 PET/CT scan
15960829|NCT03182179|Drug|Ondansetron 4 MG|Ondansetron is taken orally BD
15960830|NCT03182179|Drug|Placebo|Placebo is taken orally BD
15960831|NCT03182166|Drug|Golimumab (Optimization)|"Increase dose of golimumab.
~For patients treated at 50 mg will be performed, dose will be intensified at 100 mg every four weeks.
~For patients treated at 100 mg will be performed, dose will be intensified at 100 mg every two weeks while four weeks."
15960832|NCT03182166|Diagnostic Test|Rectosigmoidoscopy|Rectosigmoidoscopy will be realized for calculated Mayo score
15960833|NCT03182166|Biological|Blood samples|Blood samples will be collected for analysis the concentration of golimumab and antibodies to golimumab (ADAb) in the blood
15960834|NCT03182153|Device|Extended Cardiac Monitoring|Extended External Cardiac Monitoring
15960835|NCT03182140|Drug|Kyleena|Kyleena - intrauterine delivery system containing 19.5 mg LNG
15960836|NCT03182127|Radiation|Magnetic resonance imaging|MRI of the elbow is performed in either the supine or prone position A high-resolution surface coil is essential in order to obtain high-quality images . Elbow MRI scanning protocols consist of a combination of T1-weighted and fat-suppressed T2- or proton density-weighted images obtained in the axial, coronal oblique, and sagittal oblique imaging planes. Axial images should extend from the distal humeral diaphysis to the level of the bicipital tuberosity of the radius. From the axial images, coronal oblique images should be prescribed parallel to a line drawn through the centre of the humeral epicondyles, with sagittal oblique images prescribed perpendicular to this. Additional sequences may be helpful in certain circumstances; .
15960837|NCT03182127|Device|Ultrasound|ultrasound is performed by patient in supine or setting position,applied superficial probe , 2D image and color doppler if indicated.
15960838|NCT03182114|Other|supine position|the patient will be placed in regular supine position after spinal anesthesia
15960839|NCT03182114|Other|left lateral tilted position|the patient will be placed in left lateral tilted position after spinal anesthesia
15960840|NCT03182114|Drug|Bupivacaine|The patient will receive 10 mg Bupivacaine for spinal anesthesia
15960841|NCT03182101|Behavioral|Exposure Therapy|Exposure Therapy is a form of Cognitive Behavioral Therapy. There is strong evidence for exposure as a necessary and primary ingredient for treating anxiety and OCD, and exposure is the most common practice element in treatment protocols for anxiety.
15960842|NCT03182088|Drug|norepinephrine infusion (0.025 mcg/Kg/min)|The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine bitartrate infusion of (0.05 mcg/Kg/min) equivalent to norepinephrine base of (0.025 mcg/Kg/min)
15960979|NCT03181139|Other|ERAS pathway for Total Mastectomy|Enhanced Recovery after Surgery (ERAS) pathway for Total Mastectomy
15960843|NCT03182088|Drug|norepinephrine infusion (0.050 mcg/Kg/min)|The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine infusion of (0.1 mcg/Kg/min) equivalent to norepinephrine base of (0.050 mcg/Kg/min)
15960844|NCT03182088|Drug|norepinephrine infusion (0.075 mcg/Kg/min)|The patients will receive a bolus of 5 mcg norepinephrine followed by norepinephrine infusion of (0.15 mcg/Kg/min) equivalent to norepinephrine base of (0.075 mcg/Kg/min).
15960845|NCT03182088|Drug|Bupivacaine|The patient will receive spinal anesthesia using Bupivacaine (10 mg).
15960846|NCT03182075|Behavioral|Computerized Training|OCD participants will receive 14 sessions of training via computer within 3 weeks.
15960847|NCT03182062|Procedure|Alveolar recruitment maneuver|To start the Alveolar Recruitment Maneuver (ARM) the ventilatory mode will be changed to pressure-controlled mode (PCV) with 20 cmH2O pressure control ventilation. A respiratory rate (RR) of 15 rpm, inspiration: expiration ratio of 1:1, FiO2 of 0.8 and PEEP of 5 cmH2O. The PEEP level will be increased in 5 cmH2O steps every 10 respiratory cycles, increasing to 15 cycles in the last level of PEEP (20 cmH2O), getting an opening pressure at 40 cmH2O airway (duration of the maneuver: 160 sec.)
15960848|NCT03182062|Procedure|PEEP Titration Trial|The ventilation mode will then switch back to volume controlled ventilation with the same baseline settings but with 20 cmH2O PEEP level. Then PEEP will be reduced in 2 cmH2O steps each maintained for 5 breaths the level of PEEP with the best (higher) dynamic compliance.
15960849|NCT03182062|Procedure|Lung protective ventilation|Ventilatory strategy with a PEEP level of 5 cmH2O but without recruitment maneuvers and PEEP titration trial.
15960850|NCT03182049|Procedure|Airway assessment|Airway Specialist (Otolaryngology, Pulmonology, Thoracic Surgery), assess clinical location and degree of airway compromise, glottic mobility, and sinonasal disease.
15960851|NCT03182049|Procedure|Rheumatology assessment|Clinically assess systemic function (renal/pulmonary ect), biochemical profile (routine labs), neurocognitive function, and completing entry BVAS tool.
15960852|NCT03182036|Device|Portable pulsed oxygen|Hypoxemic patients will use portable pulsed oxygen at rest, and while performing a six-minute walk test.
15960853|NCT03182010|Device|Cesarean section incision closure using barbed sutures|Cesarean section incision will be closed using a 24-cm × 24-cm 0 polydioxanone double-armed suture on a 26-mm half-circle reverse cutting needle( STRATAFIX™ Spiral PDO Knotless Tissue Control Device, Ethicon Inc , Somerville, NJ, USA ).Ultrasound examination will be performed 6 months after the operation to measure the residual myometrial thickness and the scar depth.
15960854|NCT03182010|Device|Cesarean section incision closure using conventional sutures|Cesarean section incision will be closed using 1-0 polyglactin 910 suture(VICRYL™.; Ethicon Inc, Sommerville, NJ) .Ultrasound examination will be performed 6 months after the operation to measure the residual myometrial thickness and the scar depth.
15960855|NCT03181997|Device|Native aortic valve|Native valve, with any transcatheter heart valve type
15960856|NCT03181997|Procedure|Transcatheter aortic valve implantation (TAVI)|Percutaneous aortic valve implantation preformed in one of these methods: transfemoral, transapical,subclavian or other.
15960857|NCT03181984|Drug|Hemoporfin|Hemoporfin mediated photodynamic therapy
15960859|NCT03181958|Device|NHFOV|Nasal high frequency oscillation ventilation (NHFOV) is used as the noninvasive supporting mode after extubation.
15960860|NCT03181958|Device|NCPAP|Nasal continuous positive airway pressure(NCPAP) is used as the noninvasive supporting mode after extubation.
15960861|NCT03181958|Device|NIPPV|Nasal intermittent positive pressure ventilation(NIPPV) is used as the noninvasive supporting mode after extubation.
15960862|NCT03181945|Other|Group 4 weeks|Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 4 weeks followed by taper in 10-14days
15960863|NCT03181945|Other|Group 12 weeks|Anti-epileptic drug (as used by treating physician for management of acute symptomatic seizure) for 12 weeks followed by taper in 10-14days
15960864|NCT03181932|Drug|Vancomycin inhalation powder|100 participants are to be treated with double-blind vancomycin inhalation powder (75 subjects ≤21 years old, 25 subjects >21 years old) for 24 weeks during Period 1.
15960865|NCT03181932|Drug|Placebo inhalation powder|100 participants are to be treated with double-blind placebo (75 subjects ≤21 years old, 25 subjects >21 years old) for 24 weeks during Period 1.
15960866|NCT03181932|Drug|Vancomycin inhalation powder|In the 24-week Period 2, all participants are to be treated with open-label vancomycin inhalation powder.
15960867|NCT03181919|Drug|Letrozole|Letrozole is a third generation inhibitor that is emerging as a new oral agent for induction of ovulation.
15960868|NCT03181906|Other|Pre-Consultation Medication Reconciliation|Medication reconciliation service to be done for participants randomised to the intervention group
15960869|NCT03181893|Drug|PF-06823859 low|A humanized immunoglobulin neutralizing antibody
15960870|NCT03181893|Drug|Placebo Arm|Placebo contains histidine, sucrose, PS80, ethylene diamine, and triacetic acid
15960871|NCT03181893|Drug|PF-06823859 high|A humanized immunoglobulin neutralizing antibody
15960872|NCT03181880|Drug|Aclidinium bromide/formoterol fumarate combination|"Patients will be randomized to receive either Aclidinium bromide/formoterol fumarate fixed-dose combination (Duaklir™ Genuair®), or Standard Of Care (SOC) Bronchodilators.
~The product in study is Aclidinium bromide/formoterol fumarate fixed-dose combination (Duaklir™ Genuair®).
~Each inhaler will contain at least 60 doses (and a maximum of 68 doses) of aclidinium bromide/formoterol fixed-dose combination 400μg /12μg. Patients will be instructed to take 1 puff in the morning (09:00 ± 1 h) and 1 puff in the evening (21:00 ± 1 h) during the 12 weeks of treatment."
15960873|NCT03181880|Drug|Standard of Care|Brochodilators
15960874|NCT03181867|Drug|18F-DCFPyL|Subjects will receive IV dose of 18F-DCFPyL by bolus injection. The maximum amount of injected active drug will be less than 4.02 mcg. The target administered activity will be 8 mCi.
15960875|NCT03181867|Drug|18F-FDG|Cohort 2 may receive a one-time 18F-FDG PET/CT after a positive 18F-DCPyL PET/CT. 18F FDG PET/CT imaging may be performed per clinical standard of care. FDG is administered at a dose of 10mCi intravenously. A whole-body PET/CT will be performed beginning post 18F FDG injection.
15960980|NCT03181126|Drug|Navitoclax|tablet
15960876|NCT03181854|Behavioral|Telephone coaching|Telephone coaching about overcoming the crisis is provided once a week for 3 months and once in 2 weeks for another 3 months.
15960877|NCT03181854|Behavioral|Consultation with PCT doctor|Consultation with PCT physician every 3 weeks.
15960878|NCT03181841|Drug|PF-06412562|double-blind oral intake of single doses of the aforementioned drug or placebo
15960879|NCT03181841|Drug|Placebo|double-blind oral intake of single doses of the aforementioned drug or placebo
15960880|NCT03181828|Drug|Acetohydroxamic Acid Oral Tablet [Lithostat]|"AHA:
~Acetohydroxamic acid has been an FDA approved medication for the treatment of struvite nephrolithiasis for over 25 years. According to the prescribing information, about 150 patients, including children, have been treated, most for periods of more than 1 year."
15960881|NCT03181815|Drug|Cladribine|5mg/㎡ d1-5
15960882|NCT03181815|Drug|G-CSF|300ug d0-9
15960883|NCT03181815|Drug|Aclarubicin|10mg d3-6
15960884|NCT03181815|Drug|Cytarabine|10mg/㎡ q12h SC d3-9
15960885|NCT03181802|Drug|Botox|single injection of 200 International Unit of BoNT-A in 10 bilateral paravertebral intramuscular points for treating chronic LBP
15960886|NCT03181802|Drug|Placebos|4 ml of physiological serum injected intramuscularly into the lumbar paravertebral muscles.
15960887|NCT03181789|Biological|p24CE1/2 pDNA Vaccine|Administered bilaterally using the Ichor Medical Systems Intramuscular TriGrid Delivery System (TDS-IM) electroporation (EP) device
15960888|NCT03181789|Biological|p55^gag pDNA Vaccine|Administered bilaterally using the TDS-IM EP device
15960889|NCT03181789|Biological|IL-12 pDNA Adjuvant|Administered bilaterally using the TDS-IM EP device
15960890|NCT03181789|Biological|Placebo|Administered bilaterally using the TDS-IM EP device
15960891|NCT03181789|Device|Ichor Medical Systems Intramuscular TriGrid Delivery System (TDS-IM) electroporation (EP) device|The TDS-IM EP device will be used to administer study product(s).
15960892|NCT03181776|Other|left lateral tilting in 15 degrees|The mother will be placed in left lateral tilted position (15 degrees) using a standard wedge
15960893|NCT03181776|Other|left lateral tilting in 30 degrees|The mother will be placed in left lateral tilted position (30 degrees) using a standard wedge
15960894|NCT03181776|Other|supine position|The mother will be placed in standard supine position
15960895|NCT03181763|Drug|Placebo|Placebo given day after startle assessment
15960896|NCT03181763|Drug|MDMA|Participant will receive 100 mg MDMA one day after startle assessment
15960897|NCT03181763|Behavioral|Acoustic startle|Startle assessment
15960898|NCT03181750|Behavioral|Patient Navigator Intervention Group|Bicultural, bilingual navigators conducting home visits with patients and caregivers.
15960899|NCT03181737|Behavioral|Covivio/Relaxio|Informations already included in arm/group descriptions.
15960900|NCT03181724|Behavioral|Decision Aid|"Cohort I will be managed with a decision aid (henceforth DA), and Cohort II will be managed without one. The patients in Cohort I will receive the DA, which they can complete in a separate room and take home. The decision aids include information on the disease/condition, treatment options, benefits, risks, scientific uncertainties, and probabilities of potential outcomes tailored to the patient's health risks factors. Additionally, it includes values clarifications such as describing outcomes in functional terms, asking patients to consider which benefits and risks matter most to them, and guidance in the steps of decision making and discussing their decision with family/friends. It is interactive and dynamic, helping patients clarify their preferences and come to a decision that feels best to them."
15960901|NCT03181698|Diagnostic Test|Magnetic resonance imaging|"A full Magnetic Resonance Imaging examination of the brain will be done for each of the subjects included in the study. The protocol of the study will include a high-resolution thin-cuts three Dimensions-T1 weighted gradient echo sequence to be used for the morphometric study.
~The obtained images will be analyzed for any gross structural abnormalities. by using fully-automated computational voxel-based volumetric software that calculates the volume of different structures of the brain. The obtained data will be analyzed statistically using linear regression tests to determine the differences between Bipolar Disorder type I mania patients and the healthy controls"
15960902|NCT03181685|Drug|Progesterone 25 MG subcutaneous|A single subcutaneous administration per day from the day of oocyte retrieval
15960903|NCT03181685|Drug|Micronized progesterone 200 MG|3 vaginal administrations per day from the day of oocyte retrieval
15960904|NCT03181685|Drug|recombinant FSH|Controlled ovarian stimulation (COS)
15960905|NCT03181685|Drug|Cetrorelix Acetate|Inhibition of Luteinizing Hormone (LH) premature surge during COS
15960906|NCT03181672|Procedure|Stellate ganglion block|Stellate ganglion block with 1% lidocaine 10ml
15960907|NCT03181672|Procedure|control group|Deltoid muscle injection with 1% lidocaine 10ml
15960908|NCT03181659|Procedure|Manual Therapy, Therapeutic Education, Therapeutic Exercice|They will receive 8 sessions (2 sessions per week) of joint and neural manual therapy, and will receive 4 sessions (1 session per week) of neuroscience education in which mirror therapy and image observation. The therapeutic exercise program is based on stabilization of the lumbopelvic region.
15960909|NCT03181659|Procedure|Therapeutic Education, Therapeutic Exercice|They will receive a total of 8 sessions (2 sessions per week) of therapeutic exercise based on the stabilization of the lumbopelvic region and will receive 4 sessions (1 session per week) of neuroscience education in which mirror therapy and image observation.
15960910|NCT03181646|Drug|citicoline|intravenous citicoline 15 mg per kg per dose BD will be given to babies until oral feeds are established
15960911|NCT03181633|Drug|ACH-0144471|ACH-0144471 will be administered to all participants enrolled in the study.
15960912|NCT03181620|Other|Intermittent Dosing of Medication|Typical sedative/narcotic medication administered for sedation while mechanically ventilated is given in an intravenous intermittent bolus fashion rather than a continuous intravenous drip.
15960913|NCT03181594|Device|ClariFix Device|Cryoablation in the nasal passageway using the ClariFix Device
15960914|NCT03181581|Biological|acoustic coupling fluid|ultrasound images obtained with both ACF and Ringer's acetate
15960915|NCT03181581|Biological|Ringer's acetate|ultrasound images obtained with Ringer's acetate only
15960981|NCT03181126|Drug|Chemotherapy|peg-asparaginase (or other form of asparaginase, per local standard of care (intravenous) + vincristine (intravenous) + dexamethasone (oral) + tyrosine kinase inhibitor (TKI) (if applicable, oral)
15960982|NCT03181126|Drug|Venetoclax|tablet
15960916|NCT03181568|Device|MolecuLight i:X™ Imaging Device|Offers real-time detection of important biological and molecular information of a wound. The MolecuLight i:X Imaging Device is intended to assist clinicians during care and management of patients with chronic wounds by screening for the presence of potentially harmful bacteria levels. The device can capture and document either an image or video of the wound where the presence of fluorescent bacteria appears under violet light illumination. This information can be used to guide a clinician to inspect, sample, debride or further evaluate areas within or around a wound where fluorescent bacteria are present.
15960917|NCT03181568|Procedure|Wound care|Standard wound care of chronic wounds e.g. sampling, debridement, infection control
15960918|NCT03181555|Other|Exploratory|
15960919|NCT03181542|Device|Infrared illumination|Infrared illumination of veins using the FDA approved AccuVein (AccuVein, Inc., Huntington, NY) device.
15960920|NCT03181529|Drug|Psilocybin|Participants will receive a moderately high psilocybin dose in the first session and will receive either a moderately high or high psilocybin dose in the second session.
15960921|NCT03181516|Biological|Bifidobacterium animalis subsp. lactis BB-12|Bifidobacterium animalis subsp. lactis BB-12-supplemented yogurt
15960922|NCT03181516|Other|Control|Yogurt without Bifidobacterium animalis subsp. lactis BB-12
15960923|NCT03181503|Drug|CD14152 Dose A|3 subcutaneous injections (every 4 weeks during the 12-week treatment period)
15960924|NCT03181503|Drug|CD14152 placebo|3 subcutaneous injections (every 4 weeks during the 12-week treatment period)
15960925|NCT03181490|Diagnostic Test|Circulating Tumor DNA Methylation Test|Methylation profiling by high-throughput bisulfite DNA sequencing in blood sample to differentiate benign and malignant pulmonary nodules
15960926|NCT03181477|Device|Radiotherapy|Radiotherapy of 80 GY + Chemotherapy (Temozolomide)
15960927|NCT03181464|Drug|Lidocaine 4%|lidocaine solution
15960928|NCT03181464|Drug|Placebo|saline .9% injection
15960929|NCT03181451|Drug|Ferric Maltol|To assess the pharmacokinetics and iron uptake of Ferric Maltol through measurement of serum iron, transferrin saturation (TSAT) and plasma concentrations of maltol and maltol glucuronide.
15960930|NCT03181438|Procedure|TAP Block|It will be performed a ultrasound-guided transverse abdominal plane block with 20 ml of 0.375% of ropivacaine for patients submitted to renal transplantation
15960931|NCT03181438|Procedure|Saline Group|t will be performed a ultrasound-guided transverse abdominal plane block with 2o mL of saline for patients submitted to renal transplantation
15960932|NCT03181412|Diagnostic Test|Questionnaire|"Tests from Cincinnati prehospital stroke severity scale (CPSSS) will be carried out by the physician at emergency medical services on telephone call with firemen, paramedics or the emergency medical services team for any stroke suspicion that meets the criteria for inclusion. Emergency department physician will have to follow a standardized questionnaire to complete the different items of the score. The score will not be calculated by emergency department physician and will not influence the orientation and management of patients.
~The final diagnosis will be the presence or absence of a large vessel occlusion. This diagnosis will be done on cerebral imaging by a neurologist."
15960933|NCT03181399|Drug|Triheptanoin|. Triheptanoin will be taken 4 times per day (approximately every 6 hours: prior to breakfast, lunch and dinner and a mid-afternoon snack) by mouth. It is dosed 4 times per day, divided evenly.
15960934|NCT03181386|Drug|Rivaroxaban|Rivaroxaban 15 or 20mg tablet by mouth, every 24 hours, continuous use.
15960935|NCT03181386|Drug|Dabigatran and Apixaban|Dabigatrana 110 or 150 mg tablet and Apixaban 2,5 or 5mg tablet by mouth, every 12 hours, continuous use.
15960936|NCT03181386|Drug|Warfarin|The dosage of Warfarin is individualized for each patient, according to the patient's TP/INR value. The value of TP/INR should be in the therapeutic dosage of 2.0 to 3.0
15960937|NCT03181373|Other|Cognitive rehabilitation program|Rehabilitation
15960938|NCT03181360|Drug|Tenecteplase|Single dose intravenous injection of recombinant fibrin-specific tissue plasminogen activator (tenecteplase) 0.25 mg (200 IU) per kg body weight up to a maximum of 25 mg (5000 IU), given as a bolus over approx. 10 seconds.
15960939|NCT03181360|Other|Control|Best standard treatment
15960940|NCT03181347|Procedure|RYGB|Roux-en-Y Gastric Bypass
15960941|NCT03181347|Procedure|SG|Sleeve Gastrectomy
15960942|NCT03181347|Behavioral|Dietary and behavioral|Dietary and activity modifications and excludes meal replacement or pharmacologic interventions
15960943|NCT03181334|Behavioral|Branch I|FIT kits and a Standard (control) invitation letter to complete CRC screening is mailed to the homes of eligible patients.
15960944|NCT03181334|Behavioral|Branch II|"FIT kits and a Brief Time invitation to complete CRC screening is mailed to the homes of eligible patients. Time letters are used to evaluate the effect of procrastination on CRC screening compliance.
~Participants are assigned to the following intervention:
~Branch II: Invitation letter to participate in free CRC screening, requesting they return the kit within 1-week."
15960945|NCT03181334|Behavioral|Branch III|"FIT kits and an Extended Time invitation to complete CRC screening is mailed to the homes of eligible patients. Time letters are used to evaluate the effect of procrastination on CRC screening compliance.
~Participants are assigned to the following intervention:
~Branch III: Invitation letter to participate in free CRC screening, requesting they return the kit within 3-weeks."
15960946|NCT03181334|Behavioral|Branch IV|"FIT kits and a Time + Incentive invitation to complete CRC screening is mailed to the homes of eligible patients. Time + Incentive letters are used to evaluate the effect of incentive on procrastination in CRC screening compliance.
~Participants are assigned to the following intervention:
~Branch IV: Invitation letter to participate in free CRC screening, requesting they return the kit within 1-week for a higher incentive or within 3-weeks for a lower (half of the higher) incentive."
15960947|NCT03181334|Behavioral|Branch V|"FIT kits and a Time + Incentive invitation to complete CRC screening is mailed to the homes of eligible patients. Time + Incentive letters are used to evaluate the effect of incentive on procrastination in CRC screening compliance.
~Participants are assigned to the following intervention:
~Branch V: Invitation letter to participate in free CRC screening, requesting they return the kit within 1-week for a higher (same as lower Branch IV) or within 3-weeks for a lower (half of lower Branch IV) incentive."
15960983|NCT03181113|Drug|Peginterferon Alfa-2B|pre-received standard peginterferon alfa-2b therapy
15960984|NCT03181113|Drug|Peginterferon Alfa-2A|pre-received standard peginterferon alfa-2a therapy
15960985|NCT03181100|Drug|Atezolizumab|Given IV
15960948|NCT03181321|Behavioral|The First Twenty|The TF20 incorporates individual goal setting and health coaching, leveraging cultural aspects of the fire service and group cohesion to motivate behavior change. The TF20 focuses on the unique needs of FF with culturally relevant nutrition and fitness strategies. TF20 was primarily designed as a cost-effective, stand-alone program for departments which have no health promotion initiative. Program components include practical approaches to nutrition, fitness and mental health.
15960949|NCT03181308|Drug|Carotuximab (TRC105)|Anti Endoglin Antibody
15960950|NCT03181308|Drug|OPDIVO|Programmed Death Receptor-1
15960951|NCT03181295|Behavioral|Personalized exercise Rx and resources|Patients will receive the IPAQ to collect baseline PA levels as well as questions evaluating precursors to behaviour change and identifying medical conditions that may affect PA capability. In the Electronic Medical Record chart, a 'stamp' will be automatically created, accompanied by a link which will open a printable 'toolkit' with individualized PA recommendations, a personalized exercise Rx, as well as educational and community resources, all based on the patient's survey responses. The exercise Rx and resources can be edited by the PCP based on the resulting discussion between patient and PCP, and printed during the PHR for the patient to take home. The exercise Rx and resources will also be emailed to the patient following their appointment.
15960952|NCT03181282|Behavioral|Physical Therapy|Postural stability exercises will follow a framework targeting quiet stance, anticipatory and reactive postural adjustments, and dynamic postural control. Gait exercises will include treadmill walking and practice with dual-task gait. A home exercise program (HEP), to be completed twice weekly, will be provided on each participant's initial visit with the physical therapist following STN-DBS surgery. The HEP will include the following exercises: trunk rotation, standing hip flexion, standing hip abduction, standing plantarflexion, and standing squat.
15960953|NCT03181269|Other|Intervention education|An education package that includes an enhanced emphasis on maternal-infant skin-to-skin contact and a detailed activity log for recording early post-partum care practices that includes specific skin-to-skin contact time and frequency goals.
15960954|NCT03181269|Other|Placebo Education|An education package that includes a basic emphasis on maternal-infant skin-to-skin contact, as well as other general post-partum care practices and a general early post-partum care practices log without specific skin-to-skin contact goals.
15960955|NCT03181256|Procedure|Biospecimen Collection|Undergo collection of sputum
15960956|NCT03181256|Procedure|Biospecimen collection|Undergo collection of nasal epithelium
15960957|NCT03181256|Procedure|Biospecimen collection|Undergo collection of buccal epithelium
15960958|NCT03181256|Procedure|Biospecimen collection|Undergo collection of blood
15960959|NCT03181256|Procedure|Biospecimen collection|Undergo collection of urine
15960960|NCT03181256|Procedure|Pulmonary Function Test|Undergo pulmonary function test
15960961|NCT03181256|Procedure|Computed Tomography (CT)|Undergo chest CT
15960962|NCT03181256|Other|Laboratory Biomarker|Correlative studies
15960963|NCT03181243|Procedure|Madajet|The spermatic cord is firmly trapped between the middle finger, index finger and thumb of the left hand. The injector's sheath is placed over the spermatic cord with gentle pressure adjacent to the external inguinal ring. Depending upon the thickness of spermatic cord, three or four injections are consecutively administered around it, beginning from proximal to distal points.
15960964|NCT03181243|Procedure|Needle injection|The pubic tubercle is palpated on the side that is going to be blocked. The spermatic cord is then immobilised with the non-dominant hand between the thumb and index finger. Right after needle puncture with attached syringe and local anaesthetic solution is conducted at a point that is 1 cm inferior to and 1 cm medial to the pubic tubercle, pass the needle directly downward in a vertical fashion, which leads it into the spermatic cord. After a check-up (negative aspiration) for bleeding, approximately 3 mL of solution (Lidocaine 2%) is injected into the cord.
15960965|NCT03181230|Other|No intervention|No intervention
15960966|NCT03181217|Other|water 0|300 ml tap water at 0 ºC
15960967|NCT03181217|Other|water 22|300 ml tap water at 22 ºC
15960968|NCT03181217|Other|Glucose 0|300 ml tap water at 0 ºC with 75 grams of glucose added
15960969|NCT03181217|Other|Glucose 22|300 ml tap water at 22 ºC with 75 grams of glucose added
15960973|NCT03181191|Other|Oral glucose tolerance test|Oral glucose tolerance test and biopsies
15960974|NCT03181178|Dietary Supplement|Macro-micronutrient complementary food supplement|This intervention provided a 15 g complementary food supplement called KokoPlus with nutrition education
15960975|NCT03181178|Dietary Supplement|A micronutrient powder|This intervention provided a 1 g micronutrient powder with nutrition education
15960976|NCT03181178|Behavioral|Nutrition education|This intervention provided nutrition education sessions
15960977|NCT03181165|Behavioral|Low-carbohydrate Therapeutic Nutrition|The pharmacist or pharmacy lifestyle coach will work with the participant to develop a diet plan that is low in carbohydrate and energy-restricted based on personal preferences and characteristics. A combination of pre-packaged low-carbohydrate foods and whole foods from pre-specified lists will be used.
15960978|NCT03181152|Diagnostic Test|Impulse Oscillometry|"1，Before the experiment, the patient is arranged to rest 10min. 2, IOS: The patient take seats, body relax, make sure the mouthpiece is fully covered by mouth, then clip nose with both hands to cover both sides of the cheek, and then calm breathing 1 minutes, the computer is automatically collected data calculation and print out the measurement results.
~3, Bronchial Dilation Test: The patient is asked to take IOS again after gaven aerosol inhalation of 200g salbutamol for 15min, the computer is automatically collects the data computation and prints the measurement result."
15960991|NCT03181087|Other|Umbilical cord MSCs|Participants will receive direct local intramuscular injection of 1*10^7 MSCs (in 1ml of 0.9% saline) in the uterine incision.
15960992|NCT03181074|Other|Non-Interventional|Non-Interventional
15960993|NCT03181061|Other|Semi-structured interviews|Providers will participate in a semi-structured interview using an interview guide that addresses 4 domains of interest including: (1) initiation of abortion services, (2) barriers to abortion provision, (3) facilitators of abortion provision and (4) acquired expertise and coaching for success.
15960994|NCT03181048|Procedure|Periacetabular osteotomy|The Bernese periacetabular osteotomy has become the osteotomy of choice in North America for correction of the dysplastic hip. The ability to position the acetabular component in a specifically desired position for each individual patient improves joint biomechanics, restores joint balance and stability, and offloads the structures at risk for damage such as the labrum and the adjacent articular cartilage.
15960995|NCT03181048|Procedure|Periacetabular osteotomy with hip arthroscopy|An intraarticular assessment with hip arthroscopy (HA) at the time of periacetabular osteotomy allows the surgeon to assess and treat the associated labral and chondral pathology and allows the surgeon to treat abnormalities of the femoral head junction.
15960998|NCT03181022|Behavioral|Motivational Interviewing|HIV care providers will be asked to attend an MI training workshop lasting a total of 12 hours. The workshop will be conducted by members of the MI Network of Trainers. MI training relies on experiential activities and cooperative learning methods. After the training, study staff will monitor MI fidelity, or how providers are using the MI skills, using the MI Coach Rating Scale. This will occur 3 times prior to the training, 3 times during the practice period, and then quarterly. They will be asked to complete an audiotaped standardized patient interaction (approximately 30 minutes) with one of the study staff. These will be coded and providers will be informed of their competency level for all but the pre-training role plays. Coaching will be provided for all participants during the practice period. For the quarterly role plays, no coaching occurs unless their score indicates they need additional coaching (an additional 45 minute session with an MI trainer).
15960999|NCT03181009|Drug|Omalizumab|All subjects will receive omalizumab, stored and prepared according to the investigator brochure. Subjects greater or equal to 4 yrs receive 150 mg. Subjects less than 4 yrs receive 75 mg.
15961000|NCT03181009|Drug|Food Flour Allergens|The subject's allergens will be introduced after receiving the third omalizumab dose.. Subjects will return to clinic to escalate the dose of their allergens until 300 mg (group A) vs. 1200 mg (group B) total protein daily dose is reached. There will be equivalent allergen protein portions depending on test allergen per each subject's history. Subjects will be randomized 1:1 to either group A or group B after meeting eligibility criteria. All subjects and study personnel will be blinded to group A vs B. Research staff will administer food flour to the subject orally in an age-appropriate food vehicle.
15961001|NCT03180996|Device|Vascutek Fenestrated Anaconda™ Custom AAA Stent Graft System|Fenestrated Endovascular Aortic Repair (FEVAR)
15961002|NCT03180983|Behavioral|multimodal intervention|Investigators will propose an online training. In addition, investigators will make phone calls to nursing home interlocutor between two nursing home visits. The tools of this intervention will consist on posters , quiz about bacteriuria and urinary tract infection (UTI) and algorithm to help nurse's reasoning when UTI is suspected.
15961003|NCT03180970|Drug|1.2% Lugol's solution|1.2% Lugol's solution will be sprayed on the lesion suspected early esophageal squamous neoplasia .Then the lesions will be treated with endoscopic submucosal dissection(ESD).
15961004|NCT03180970|Drug|1.0% Lugol's solution|1.0% Lugol's solution will be sprayed on the lesion suspected early esophageal squamous neoplasia .Then the lesions will be treated with endoscopic submucosal dissection(ESD).
15961005|NCT03180970|Drug|0.8% Lugol's solution|0.8% Lugol's solution will be sprayed on the lesion suspected early esophageal squamous neoplasia .Then the lesions will be treated with endoscopic submucosal dissection(ESD).
15961006|NCT03180970|Drug|0.6% Lugol's solution|0.6% Lugol's solution will be sprayed on the lesion suspected early esophageal squamous neoplasia .Then the lesions will be treated with endoscopic submucosal dissection(ESD).
15961007|NCT03180970|Drug|0.4% Lugol's solution|0.4% Lugol's solution will be sprayed on the lesion suspected early esophageal squamous neoplasia .Then the lesions will be treated with endoscopic submucosal dissection(ESD).
15961008|NCT03180957|Drug|Adalimumab|
15961009|NCT03180957|Drug|Saline|
15961010|NCT03180944|Drug|1.2% Lugol's solution|This group patients were given concentrations of 1.2% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.
15961011|NCT03180944|Drug|1.0% Lugol's solution|This group patients were given concentrations of 1.0% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.
15961012|NCT03180944|Drug|0.8% Lugol's solution|This group patients were given concentrations of 0.8% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.
15961013|NCT03180944|Drug|0.6% Lugol's solution|This group patients were given concentrations of 0.6% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.
15961014|NCT03180944|Drug|0.4% Lugol's solution|This group patients were given concentrations of 0.4% Lugol's solution for chromoendoscopy.Then biopsy specimens will be taken at the well-demarcated unstained or less-stained lesions.
15961015|NCT03180931|Device|Bioresorbable vascular scaffold|"No study specific procedures will be applied. Optical coherence tomography recordings at the time of very late scaffold thrombosis were obtained during clinical routine with one of the commercially available and approved optical coherence tomography consoles and catheters. The analysis will be conducted at the Core laboratory at Bern University Hospital, Bern, Switzerland using a systematic and validated approach.
~Every participant will be coded by getting a number (pseudonym) in the local institutes. In the Core Laboratory, data will be further coded to ensure anonymity of the participants."
15961016|NCT03180918|Procedure|testicular tissue biopsy|testicular tissue biopsy during general anesthesia
15961017|NCT03180905|Device|ImPACT Online/Paper Pencil Tests|Compare ImPACT Online versus Paper and Pencil Neurocognitive Tests
15961018|NCT03180905|Device|ImPACT Online|ImPACT Online will be administered at 2 time points.
15961019|NCT03180892|Other|The investigators did not apply any intervention for the participants.|The investigators did not apply any intervention for the participants.
15961020|NCT03180879|Drug|Test - RB ibuprofen acid orodispersible tablets|RB ibuprofen acid orodispersible tablets, 2 x 200 mg, single dose, oral.
15961021|NCT03180879|Drug|Reference - RB Nurofen ibuprofen acid tablets|RB Nurofen ibuprofen acid tablets, 2 x 200 mg, single dose, oral.
15961022|NCT03180879|Drug|Comparator - Dolormin ibuprofen lysine tablets|Dolormin ibuprofen lysine tablets 2 x 342 mg (each 342 mg tablet contains 200 mg ibuprofen), single dose, oral.
15961023|NCT03180866|Device|Luma Light System|The Luma Light System combines a NBUVB light with an occlusive dressing.
15961024|NCT03180840|Biological|Pegunigalsidase alfa|Pegunigalsidase alfa 2 mg/kg every 4 weeks
15961025|NCT03180827|Procedure|ovarian tissue biopsy|ovarian tissue biopsy during general anesthesia
15961026|NCT03180814|Other|Whole Body Vibration|A whole body vibration session will be performed through a vibrating platform with three axes and vibration frequency set at 35 Hz. The amplitude used will be 04 mm.
15961027|NCT03180801|Biological|adjuvanted FLU-v|Subcutaneous injection in the upper arm with 500mcg of FLU-v as 0.5ml emulsion in 0.25ml of WFI and 0.25ml of adjuvant Montanide ISA-51
15961028|NCT03180801|Biological|adjuvanted placebo|Subcutaneous injection in the upper arm with 0.5ml emulsion made of 0.25ml of WFI and 0.25ml of adjuvant Montanide ISA-51
15961029|NCT03180801|Other|Influenza challenge|On day 0, administration with an intranasal sprayer of 1ml of PBS containing 10(7) TCID50 of Influenza A 2009 H1N1 human virus manufactured under GMP in certified Vero cells.
15961030|NCT03180788|Procedure|Traction assisted ESD|A clip attached to a thread is mounted on the lesion. Traction is achieved by pulling the thread during ESD
15961031|NCT03180788|Procedure|Traditional ESD|Endoscopic submucosa dissection
15961032|NCT03180775|Other|Cellulose (control)|Cellulose (a vegetal product, in powder form, used as dietary fiber, that is not digested or absorbed in the intestines), will be supplemented in the form of water soluble powder.
15961033|NCT03180775|Dietary Supplement|Glycine|Amino acids are the building blocks of proteins, they are essential organic compounds in the normal diet, and are also individually administered as nutritional supplements. Glycine will be supplied in the form of water soluble powder (the commercial form), for one daily dose. The corresponding amino acid doses were established based on the highest intakes at the 99th percentile in adult men (Institute of Medicine. 2005. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, D.C.: The National Academies Press. doi.org/10.17226/10490).
15961034|NCT03180775|Dietary Supplement|Alanine|Amino acids are the building blocks of proteins, they are essential organic compounds in the normal diet, and are also individually administered as nutritional supplements. Alanine will be supplied in the form of water soluble powder (the commercial form), for one daily dose. The corresponding amino acid doses were established based on the highest intakes at the 99th percentile in adult men (Institute of Medicine. 2005. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, D.C.: The National Academies Press. doi.org/10.17226/10490).
15961035|NCT03180775|Dietary Supplement|Leucine|Amino acids are the building blocks of proteins, they are essential organic compounds in the normal diet, and are also individually administered as nutritional supplements. Leucine will be supplied in the form of water soluble powder (the commercial form), for one daily dose. The corresponding amino acid doses were established based on the highest intakes at the 99th percentile in adult men (Institute of Medicine. 2005. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, D.C.: The National Academies Press. doi.org/10.17226/10490).
15961036|NCT03180775|Dietary Supplement|Isoleucine|Amino acids are the building blocks of proteins, they are essential organic compounds in the normal diet, and are also individually administered as nutritional supplements. Isoleucine will be supplied in the form of water soluble powder (the commercial form), for one daily dose. The corresponding amino acid doses were established based on the highest intakes at the 99th percentile in adult men (Institute of Medicine. 2005. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, D.C.: The National Academies Press. doi.org/10.17226/10490).
15961037|NCT03180775|Dietary Supplement|Valine|Amino acids are the building blocks of proteins, they are essential organic compounds in the normal diet, and are also individually administered as nutritional supplements. Valine will be supplied in the form of water soluble powder (the commercial form), for one daily dose. The corresponding amino acid doses were established based on the highest intakes at the 99th percentile in adult men (Institute of Medicine. 2005. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, D.C.: The National Academies Press. doi.org/10.17226/10490).
15961038|NCT03180775|Dietary Supplement|Cysteine|Amino acids are the building blocks of proteins, they are essential organic compounds in the normal diet, and are also individually administered as nutritional supplements. Cysteine will be supplied in the form of water soluble powder (the commercial form), for one daily dose. The corresponding amino acid doses were established based on the highest intakes at the 99th percentile in adult men (Institute of Medicine. 2005. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, D.C.: The National Academies Press. doi.org/10.17226/10490).
15961039|NCT03180775|Dietary Supplement|Arginine|Amino acids are the building blocks of proteins, they are essential organic compounds in the normal diet, and are also individually administered as nutritional supplements. Arginine will be supplied in the form of water soluble powder (the commercial form), for one daily dose. The corresponding amino acid doses were established based on the highest intakes at the 99th percentile in adult men (Institute of Medicine. 2005. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, D.C.: The National Academies Press. doi.org/10.17226/10490).
15961040|NCT03180775|Dietary Supplement|Methionine|Amino acids are the building blocks of proteins, they are essential organic compounds in the normal diet, and are also individually administered as nutritional supplements. Methionine will be supplied in the form of water soluble powder (the commercial form), for one daily dose. The corresponding amino acid doses were established based on the highest intakes at the 99th percentile in adult men (Institute of Medicine. 2005. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, D.C.: The National Academies Press. doi.org/10.17226/10490).
15961041|NCT03180775|Dietary Supplement|Glutamate|Amino acids are the building blocks of proteins, they are essential organic compounds in the normal diet, and are also individually administered as nutritional supplements. Glutamate will be supplied in the form of water soluble powder (the commercial form), for one daily dose. The corresponding amino acid doses were established based on the highest intakes at the 99th percentile in adult men (Institute of Medicine. 2005. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, D.C.: The National Academies Press. doi.org/10.17226/10490).
15961042|NCT03180775|Dietary Supplement|Glutamine|Amino acids are the building blocks of proteins, they are essential organic compounds in the normal diet, and are also individually administered as nutritional supplements. Glutamine will be supplied in the form of water soluble powder (the commercial form), for one daily dose. The corresponding amino acid doses were established based on the highest intakes at the 99th percentile in adult men (Institute of Medicine. 2005. Dietary Reference Intakes for Energy, Carbohydrate, Fiber, Fat, Fatty Acids, Cholesterol, Protein, and Amino Acids. Washington, D.C.: The National Academies Press. doi.org/10.17226/10490).
15961043|NCT03180762|Drug|JNJ-64140284 0.1 mg|0.1 mg of JNJ-64140284 will be administered as an oral solution.
15961044|NCT03180762|Drug|JNJ-64140284 0.5 mg|0.5 mg of JNJ-64140284 will be administered as an oral solution.
15961045|NCT03180762|Drug|JNJ-64140284 2.5 mg|2.5 mg of JNJ-64140284 will be administered as an oral solution.
15961046|NCT03180762|Drug|JNJ-64140284 10 mg|10 mg of JNJ-64140284 will be administered as an oral solution.
15961047|NCT03180762|Drug|JNJ-64140284 50 mg|50 mg of JNJ-64140284 will be administered as an oral solution.
15961048|NCT03180762|Drug|JNJ-64140284 150 mg|150 mg of JNJ-64140284 will be administered as an oral solution.
15961049|NCT03180762|Drug|JNJ-64140284 (dose to be determined [TBD])|JNJ-64140284 (dose to be determined) will be administered as an oral solution.
15961050|NCT03180762|Drug|Placebo|Matching placebo will be administered.
15961051|NCT03180749|Other|Follow up per standard of care|Patients will come in 2 years post implantation and receive standard examinations
15961052|NCT03180736|Drug|Daratumumab|Daratumumab will be given at a dose of 16 mg/kg administered as an IV infusion (Dara IV) or 1800 mg subcutaneously (Dara SC) at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter. Subjects will receive pre-infusion medications before infusions to mitigate potential IRRs.
15961053|NCT03180736|Drug|Pomalidomide|Pomalidomide will be administered at full dose of 4 mg orally (PO) on Days 1 through 21 of each 28-day cycle.
15961054|NCT03180736|Drug|Dexamethasone|Dexamethasone will be administered at a dose of 40 mg (20 mg for patients ≥75 years of age) orally, once daily on Days 1, 8, 15, and 22 of each 28-day treatment cycle.
15961055|NCT03180723|Drug|Rituximab|Intravenous injection
15961056|NCT03180723|Drug|Cyclosporin|Oral tablets
15961057|NCT03180710|Drug|BioChaperone® Combo 75/25 at 0.6 U/kg|Injection of BioChaperone® Combo 75/25 at 0.6 U/kg
15961058|NCT03180710|Drug|BioChaperone® Combo 75/25 at 0.8 U/kg|Injection of BioChaperone® Combo 75/25 at 0.8 U/kg
15961059|NCT03180710|Drug|BioChaperone® Combo 75/25 at 1.0 U/kg|Injection of BioChaperone® Combo 75/25 at 1.0 U/kg
15961060|NCT03180710|Drug|Humalog® Mix25 at 0.8 U/kg|Injection of Humalog® Mix25 at 0.8 U/kg
15961061|NCT03180697|Diagnostic Test|APT MR Imaging|Patients who will receive target therapy( Bevacizumab) for recurrent malignant gliomas will obtain routine sequences, Gd- enhanced MR imaging and APT MR imaging will be performed before and after target therapy. We will observe the change of tumor after target therapy using APT imaging. We will compare the change of tumor between Gd-enhanced and APT Imaging before and after therapy.
15961062|NCT03180684|Biological|VGX-3100|One milliliter (1 mL) VGX-3100 will be injected IM and delivered by EP using CELLECTRA™ 2000 on Day 0, Week 4, Week 12 and Week 24. A fifth dose and sixth dose of six mg VGX-3100 may be administered IM with EP per the judgment of the Investigator.
15961063|NCT03180684|Drug|Imiquimod 5% cream|Participants will apply imiquimod 5% cream to the vulvar lesion three times per week for 20 weeks.
15961064|NCT03180684|Device|CELLECTRA™ 2000|IM injection of VGX-3100 is followed by EP with the CELLECTRA™ 2000 device.
15961065|NCT03180671|Device|Deprogramer Sliding Guide|Use of the intraoral device.
15961066|NCT03180671|Device|Deprogrammer Dawson B-Splint|Use of the intraoral device.
15961067|NCT03180671|Device|Deprogrammer Kois|Use of the intraoral device.
15961068|NCT03180658|Procedure|GTR + CGF + bone graft|Guided tissue regeneration (GTR) combined with CGF and bone graft to treat mandibular furcation involvements
15961069|NCT03180658|Procedure|CGF + bone graft|CGF combined with bone graft to treat mandibular furcation involvements
15961070|NCT03180645|Other|Test product (Moisturising cream)|Participants will be instructed to apply their assigned product to the randomly assigned side of the face, to include, the crow's feet area, cheek, forehead and chin twice daily (in the morning and evening).
15961071|NCT03180645|Other|Positive control (Commercial market place moisturising cream)|Participants will be instructed to apply their assigned product to the randomly assigned side of the face, to include, the crow's feet area, cheek, forehead and chin twice daily (in the morning and evening).
15961072|NCT03180645|Other|No treatment|No treatment
15961073|NCT03180632|Drug|Lorazepam|Patient receives one or two tablet of 0,5mg Lorazepam according to body weight
15961074|NCT03180632|Other|Placebo|Patient receive one of two tablet of Placebo according to body weight
15961075|NCT03180619|Drug|TAF|Tablet administered orally once daily
15961076|NCT03180606|Other|Multi-disciplinary and personalized primary care|Team-based primary care where nurse, GP, social-worker, physiotherapist, occupational therapist evaluate and give treatment
15961077|NCT03180593|Drug|Valsartan 80 mg|Compare office and 24-hour Blood Pressure Control and regression of Left Ventricular Hypertrophy
15961106|NCT03180372|Device|Hybrid Fractional Laser|Consecutive and coincident fractional 2940 nm and 1470 nm lasers
15961138|NCT03180164|Other|hospital anxiety and depression scale|self-assessment scale has been developed and found to be a reliable instrument for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic
15961179|NCT03179891|Drug|Diazepam Buccal Film 12.5 mg|All subjects received a single dose of DBF 12.5 mg during the interictal state and during the ictal/peri-ictal state with at least 14 days washout between the 2 treatment periods
15961078|NCT03180580|Behavioral|HEAL guideline and healthy tiffin box intervention|"Healthy Eating and Active Living (HEAL) guideline and healthy tiffin box intervention is a combination of intervention to promote healthy eating behavior and improve physical activity level of school going children. The guideline was developed to deliver healthy lifestyle message encouraging healthy dietary habit and physical activity pattern in order to control childhood overweight and obesity. Investigators was designed a Healthy Tiffin Box for children that contained five different compartments of various sizes for stuffing with five different food types in order to ensure healthy balanced diet including low carbohydrate, moderate protein, low fat and high vitamin. We also provided with a recommended physical activity list for children."
15961079|NCT03180567|Diagnostic Test|Genetic Mutations|By next generation sequencing
15961080|NCT03180554|Device|Transcutaneous Vagal Nerve Stimulation (tVNS)|The tVNS system consists of a non-invasive, handheld stimulator and ear electrode that participants wear like an earphone. Intensity, pulse duration, and frequency of the tVNS stimulation is optimized in order to induce signals in thick-myelinated Aβ fibres of the auricular branch of the vagus nerve (ABVN).
15961081|NCT03180554|Other|Motivational nondirective resonance breathing (MNRB)|Motivational nondirective resonance breathing (MNRB) is a type of diaphragmatic breathing technique that trains the body to breathe at resonance frequency with a mental state of open-awareness.
15961082|NCT03180541|Behavioral|Dialectical Behaviour Therapy|Dialectical Behaviour Therapy (DBT) is a psychological intervention which was originally developed for women with Borderline Personality Disorder. DBT is delivered by a team of multidisciplinary mental health professionals, and comprises of individual therapy sessions for each patient, group skills training sessions, phone coaching and consultation meetings for the clinicians on the DBT team. Group skills are delivered in blocks of three modules which teach mindfulness, distress tolerance, emotion regulation and interpersonal effectiveness. The three modules are delivered over a 24-week period and are then repeated.
15961083|NCT03180528|Drug|Remetinostat|Applied topically under bandage occlusion
15961084|NCT03180515|Device|Activa PC+S Neurostimulator|Activa PC+S Neurostimulator is approved for both aDBS and cDBS paradigms.
15961085|NCT03180502|Radiation|IMRT (Intensity-Modulated Radiation Therapy)|Undergo IMRT
15961086|NCT03180502|Radiation|Proton Beam Radiation Therapy|Undergo proton beam radiation therapy
15961087|NCT03180502|Drug|Temozolomide|Chemotherapy drug
15961088|NCT03180489|Drug|Dapagliflozin Tablet|Daily oral administration of dapagliflozin with dietary counseling to promote weight loss. Dapagliflozin 5 mg tablet will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.
15961089|NCT03180489|Drug|Placebo Tablet|Daily administration of placebo tablet with dietary counseling to promote weight loss. Matching placebo for dapagliflozin 5 mg tablet will begin as one tablet per day for the first 14-days. In the absence of complications, side effects, or unfavorable reactions, the dose will then increase to two tablets for the remainder of the study.
15961090|NCT03180476|Drug|Apatinib|Apatinib, also known as YN968D1, is a tyrosine kinase inhibitor that selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR2, also known as KDR). It is an orally bioavailable, small molecule agent which is thought to inhibit angiogenesis in cancer cells; specifically apatinib inhibits VEGF-mediated endothelial cell migration and proliferation thus blocking new blood vessel formation in tumor tissue. This agent also mildly inhibits c-Kit and c-SRC tyrosine kinases.
15961091|NCT03180463|Drug|Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)|Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#) will be injected through surgery tunnel, 2*10^7 cells,
15961092|NCT03180463|Procedure|core decompression|The surgery will drill into the femoral neck (hip bone) and through the necrotic area of the bone that died from the lack of blood flow, take out partial osseous tissue.
15961093|NCT03180450|Biological|Allogeneic umbilical cord mesenchymal stem cells (SCLnow 19#)|Allogeneic umbilical cord mesenchymal stem cells will transfusion by intravenous transplantation.
15961094|NCT03180450|Drug|conventional treatment|The drug and usage will be determined based on patient's condition, including milrinone, furosemide, beta-blocker blues, Angiotensin-Converting Enzyme Inhibitors (ACEI), angiotension receptor blocker (ARB), or antiplatelet aggregation etc.
15961095|NCT03180437|Procedure|IRE surgery|IRE surgery will be used in local tumor
15961096|NCT03180437|Biological|IRE plus γδ T cells|Combination IRE surgery and γδ T cell will be used in Pancreatic Cancer
15961097|NCT03180424|Drug|L Carnitine|L Carnitine liquid, single daily dose of 2g orally.
15961098|NCT03180424|Behavioral|Supervised exercise|Modified Otago exercise programme, 2 times a week with a duration of 45 minutes, to be supervised by a previously qualified and trained instructor. Follow up of the established plan includes an adequate monitoring, evaluating the evolution and the possible adverse effects that may appear.
15961099|NCT03180424|Drug|Placebos|Liquid substance, similar to the one containing L carnitine, in the same presentation
15961100|NCT03180424|Behavioral|Exercise at home|A schedule of exercises will be given in the consultation, which the patient will perform at home, without supervision
15961101|NCT03180411|Behavioral|Interview|"Cognitive Testing Phase Group: Participants take part in one-on-one interview with research staff and asked questions about participant's health and the disease. The interview may take from 45-60 minutes to complete.
~Pilot Testing Phase Group: After Cognitive Testing Phase interview, participants have a second one-on-one interview. The interview will last from 45-60 minutes."
15961102|NCT03180411|Behavioral|Questionnaire|Participant completes a questionnaire about the disease, what participant understands about it, and the treatment plan recommended. Participant asked to give participant's opinion about colorectal cancer follow-up materials. The questionnaire will take 35-45 minutes.
15961103|NCT03180398|Device|Multiparametric MRI|MRI will be acquired before, during and after radiation treatment to evaluate treatment response
15961104|NCT03180385|Device|Neurally-Adusted Ventilatory Assist (NAVA)|Delivery of positive pressure is based on the electrical activity of the diaphragm (Edi) via a nasogastric (NG) catheter that is placed on the phrenic nerve, which runs along the esophagus. This results in synchronous ventilation for the patient.
15961105|NCT03180385|Device|Biphasic Positive Airway Pressure Support (BiPAP)|Conventional form of non-invasive respiratory support that does not deliver positive airway pressure in a synchronous fashion.
15961178|NCT03179904|Biological|Trastuzumab|Given IV
15961107|NCT03180359|Biological|Recommended vaccine scheme according to French Vaccine Schedule 2015|"BCG
~Measles mumps rubella (MMR)
~Varicella (chicken pox)
~Rotavirus
~Seasonal flu (live vaccine delivered nasally and inactivated vaccine injectable)
~Yellow Fever
~Diphteria tetanus poliomyelitis whopping cough (DTwP)
~Haemophilus influenzae type b
~Hepatitis B
~Meningococcus conjugate
~Pneumococcus
~Human papillomavirus
~Hepatitis A
~Vaccine administration would be done according to French Vaccine Schedule 2015 for mainstream population and for grafted children or transplant candidate children"
15961108|NCT03180346|Device|PICO|Single Use Negative Pressure Dressing
15961109|NCT03180346|Device|Aquacel|Occlusive surgical dressing infused with ionized silver
15961110|NCT03180333|Drug|PNA|
15961111|NCT03180333|Drug|PNA placebo|
15961112|NCT03180320|Behavioral|BESMILE-HF program|"The following activities will be conducted as part of the BESMILE-HF program:
~Baduanjin exercise;
~evaluations of exercise capacity and clinical conditions;
~consultations on exercise prescription and management of symptoms/signs during exercise;
~education covering topics related to the CHF and exercise; and
~a series of adherence strategies."
15961113|NCT03180320|Drug|Usual medications|Throughout the study period, all participants will receive typical Western medications for chronic heart failure, according to national guidelines.
15961114|NCT03180307|Drug|OTL38|0.025 mg/kg of OTL38 in 250ml dextrose 5% in water (D5W) infused intravenously over 60 minutes
15961115|NCT03180307|Device|near infrared camera imaging system|Infrared imaging used to excite OTL38 for fluorescence
15961116|NCT03180307|Procedure|laparotomy|primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery
15961117|NCT03180294|Drug|Bupropion Hydrochloride|Given PO
15961118|NCT03180294|Other|Placebo|Given PO
15961119|NCT03180281|Drug|DPP4|sitagliptin phosphate 100mg qd
15961120|NCT03180281|Drug|Insulin|Insulin Glargine or detemir 0.2U/kg qd
15961121|NCT03180281|Drug|SU|Glimepiride 1-2mg qd
15961122|NCT03180268|Other|Clinical Observation|Undergo observation
15961123|NCT03180268|Radiation|Radiation Therapy|Undergo radiation therapy
15961124|NCT03180255|Combination Product|Dexamethasone phosphate|Ocular iontophoretic delivery of a steroid
15961125|NCT03180255|Other|Placebo|Ocular iontophoretic delivery of a placebo
15961126|NCT03180242|Biological|EG12014|EG12014, single-dose IV infusion over 90 min at 6 mg/kg
15961127|NCT03180242|Biological|EU-sourced Herceptin|EU-sourced Herceptin, single-dose IV infusion over 90 min at 6 mg/kg
15961128|NCT03180242|Biological|US-sourced Herceptin|US-sourced Herceptin, single-dose IV infusion over 90 min at 6 mg/kg
15961129|NCT03180229|Drug|Granisetron 1 Mg/mL Intravenous Solution|1 milligram (mg) will use on group Granisetron before 5 min induction
15961130|NCT03180216|Biological|Virus Specific T cells (VSTs)|"This Phase I dose-escalation trial is designed to evaluate the safety of rapidly generated multivirus-specific T-cell products with antiviral activity against CMV, EBV, adenovirus, HHV6, BK virus, JC virus, and human parainfluenza-3 (HPIV3), derived from eligible HSCT donors.
~In this trial, we will utilize a rapid generation protocol for broad spectrum multivirus-specific T cells for infusion to recipients of allogeneic hematopoietic stem cell transplant (HSCT), who are at risk of developing EBV, CMV, adenovirus, HHV6, BKV, JCV and/or HPIV3, or with PCR/culture confirmed active infection(s) of EBV, CMV, adenovirus, HHV6, BKV, JCV, and/or HPIV3 that has failed to resolve with at least 14 days of standard antiviral therapy (if available and tolerated). These cells will be derived from HSCT donors, and the study agent will be assessed at each dose for evidence of dose-limiting toxicities (DLT)."
15961131|NCT03180203|Device|INTELLiVENT-ASV|"After ICU admission:
~The first three hours: only ventilation with INTELLiVENT-ASV with Quickwean.
~After three hours: Automatic spontaneous breathing trials (SBT) is activated and SBT starts if >10minutes PEEP:<9cmH2O,FiO2:<41%,VT/IBW<5ml/kg and RSB:<106l/l*min.
~Settings SBT are MV% 25%,PEEP 5cmH2O.SBT automatically stops if respiratory rate >35b/min or increases >100% since start of SBT, FiO2 >50%, PeTCO2 increases >8mmHg.
~Extubation criteria: Leakage <50ml/hr,hemodynamically stable, awake with enough muscle strength and successful SBT >10min.
~If during mechanical ventilation the ICU care providers decide that it is necessary for the treatment, they may switch to another ventilation mode or extubate without a SBT."
15961132|NCT03180203|Device|Conventional modes|"After ICU admission:
~The first three hours: only ventilation with CMV or PS. If required care providers may change the mode to adaptive support ventilation.
~After three hours: manual SBT is required if >10min PS<11cmH2O,PEEP<9cmH2O,FiO2<41%.
~Settings SBT are PS 5cmH2O, PEEP 5cmH2O, FiO2 30%. SBT must be stopped if respiratory rate >35b/min or increases >100% since the start of SBT, saturation <92% or the PeTCO2 increases >8mmHg.
~Extubation criteria: Leakage <50ml/hr,hemodynamically stable, awake with enough muscle strength and successful SBT >10min.
~If during mechanical ventilation the ICU care providers decide that it is necessary for the treatment, they may switch to another ventilation mode or extubate without a SBT."
15961133|NCT03180190|Drug|Hydroxychloroquine Oral Tablet|"slit lamp and fundus examination using both direct and indirect ophthalmoscope Screening for HCQ ocular toxicity by
~Perimetry using Octopus perimeter and utilizing 24-2 test strategy,
~Electroretinography (ERG) under scotopic and photopic conditions and Spectral domain optical coherence tomography (SD-OCT)"
15961134|NCT03180177|Procedure|Hyperthermic Intraperitoneal Chemotherapy|HIPEC is performed as neoadjuvant chemotherapy(NACT) and postoperative chemotherapy after interval debulking surgery (IDS) for advanced-stage epithelial ovarian cancer. The first HIPEC is conducted within 24h after laparoscopic exploration or Interval debulking surgery: Paclitaxel 175 mg/m^2, 43°C, 90min. The second HIPEC is performed after 48 hours of the first HIPEC. The second HIPEC regimens are cisplatin 75 mg/m^2, 43°C, 90min.
15961135|NCT03180177|Procedure|Interval debulking surgery|Cytoreductive surgery (CRS) is performed after neoadjuvant chemotherapy.
15961136|NCT03180177|Drug|neoadjuvant chemotherapy|"Systemic chemotherapy regimens after HIPEC treatment are paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks for 2 cycles in experimental group.
~Systemic chemotherapy regimens after laparoscopic exploration are paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks for 3 cycles in control group."
15961137|NCT03180177|Drug|adjuvant chemotherapy|"Systemic chemotherapy regimens after HIPEC treatment are paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks for 2 cycles in experimental group.
~Systemic chemotherapy regimens after IDS are paclitaxel 175 mg/m^2 IV>3 hour+ carboplatin AUC = 5-6 IV>1 hour, every 3 weeks for 3 cycles in control group."
15961180|NCT03179878|Drug|Placebo|Placebo
15961139|NCT03180151|Procedure|piezotome assisted orthodontic tooth movement|"Surgical procedure
~After local anesthesia, vertical interproximal incisions will be done under the interdental papilla, on the labial aspect of upper arch using a blade No. 15.
~The incisions will be kept minimal.
~The incisions go though the periosteum, which permit the blade to reach to the alveolar bone.
~A Piezo surgical knife will be used to make the cortical alveolar incision through the gingival incisions to a depth of approximately 3mm.
~As we will not use bone graft so we don't need use suturing after cortication.
~We give patient antibiotic and analgesic cover."
15961140|NCT03180138|Behavioral|Reminders alone|Automated reminders (text and /or voice in local language) for upcoming vaccination visit(s) will be provided via cell-phone to the subject (mother / caregiver) or pregnant woman.
15961141|NCT03180138|Behavioral|Compliance-linked incentives|Automated compliance-linked incentives (as cell-phone minutes) will be provided via cell-phone to the subject (mother / caregiver) or pregnant woman.
15961142|NCT03180125|Drug|Sodium Hyaluronate|median nerve in CTS hydro-dissection using 1% lidocain followed by injection of Sodium hyaluronate guided by ultrasound
15961143|NCT03180125|Device|ultrasound|ultrasound guided injection
15961144|NCT03180125|Drug|Sodium Hyaluronate and 1% lidocain|injection in the carpal tunnel
15961145|NCT03180125|Drug|Corticosteroid and 1%lidocain|injection in the carpal tunnel
15961146|NCT03180112|Genetic|enzyme linked immunosorbent assay and polymerase chain reaction|Blood samples will be collected and analyzed for herpes simplex viruses (type one and two) antibody by sensitive enzyme-linked immunosorbent assay and quantitative polymerase chain reaction.
15961147|NCT03180099|Drug|Bupivacaine|Ultrasonically assisted, 0.5-1 mL 0.9% NaCl test is given between m.longissimus and m.iliocostalis to confirm the position of the needle and local anesthetic drugs will be given here
15961148|NCT03180099|Drug|Bupivacaine|20 ml %0.1 Bupivacaine administered to Epidural Space
15961149|NCT03180086|Other|Breast cancer risk report|An individualized report will inform women of their 5-year breast cancer risk using BCRAT or Tice (when breast density is available from a past mammogram), whichever is higher, and the average 5-year risk for women their age. The report will present 5-year risk as a frequency and in a pictograph and it will describe what experts recommend in terms of mammography screening, breast cancer prevention medications, breast MRIs, and BRCA testing, for women in their 40s based on their risk.
15961150|NCT03180073|Diagnostic Test|Ziopatch Pre discharge|Ziopatch applied 2 weeks prior to procedure
15961151|NCT03180073|Diagnostic Test|Ziopatch at Discharge|Ziopatch applied at discharge from hospital to be worn for 2 weeks
15961152|NCT03180073|Diagnostic Test|Ziopatch at 2 months|Ziopatch applied 2 months from procedure to be worn for 2 weeks
15961153|NCT03180034|Biological|Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed|Given IM
15961154|NCT03180034|Other|Questionnaire Administration|Ancillary studies
15961155|NCT03180034|Biological|Recombinant Human Papillomavirus Bivalent Vaccine|Given IM
15961156|NCT03180034|Biological|Recombinant Human Papillomavirus Nonavalent Vaccine|Given IM
15961157|NCT03180021|Procedure|MRI|"This is a multicenter, non-interventional, pilot study. Eligible subjects will have a baseline MRI of the kidney, including anatomical, DWI, BOLD, T1rho, and DCE-MRI, utilizing a macrocyclic gadolinium-based contrast agent (GBCA), followed by planned standard of care (SOC) renal biopsy and clinical laboratory assessments. Additional serum and urine will be collected from subjects at baseline for analysis of research biomarkers. Following the results of the biopsy and clinical laboratory assessments, subjects will be treated for their underlying disease at the discretion of the investigator.
~At 6 months, subjects will return to the clinic for a second MRI, SOC clinical and laboratory evaluation and collection of serum and urine for analysis of research biomarkers."
15961158|NCT03180008|Behavioral|Fit and Strong!|Fit and Strong! is a group exercise and self-management program that meets for 90 minutes, 3 days per week, for 8 weeks. Each 90 minute session consists of 60 minutes of multi-component physical activity (stretching/flexibility exercises, low-impact aerobics, and strength/resistance exercise) and 30 minutes of health education delivered from a structured curriculum. The health education topics build self-efficacy for managing arthritis through physical activity.
15961159|NCT03180008|Behavioral|Fit and Strong! Plus|The intervention consists of the traditional Fit and Strong! intervention (see previous description), but the health education component has been revised to focus on diet and weight management in addition to physical activity and arthritis.
15961160|NCT03179995|Drug|Octreotide|Octreotide will be administered 50 µg intravenously per hour for up to five days postoperatively, starting at the time of vascular inflow disruption.
15961161|NCT03179995|Other|Placebo|Normal saline will be administered in the same fashion as Octreotide
15961162|NCT03179982|Behavioral|Safe South Africa|"Core components of the Safe South Africa intervention include the following:
~Theory driven, best-evidence intervention approaches to adolescent HIV prevention
~Linkages between HIV and IPV
~Victim Empathy
~Healthy Norms Regarding Masculinity
~Bystander Intervention Skills"
15961163|NCT03179969|Other|paravalvular leak|Observational study on patients with paravalvular leak
15961164|NCT03179956|Drug|Ribociclib|Treatment with ribociclib [600mg] will be from Days 1-14, with surgical resection on Day 14. Labs (CBC, CMP, coagulation parameters) and an ECG will be checked once in a window defined by days 9-12.
15961165|NCT03179943|Drug|Atezolizumab|Patients will be administered atezolizumab intravenously on day 1 and day 22 of a 6 week cycle for the period of 8 cycles.
15961166|NCT03179943|Drug|Guadecitabine|Guadecitabine will be administered subcutaneously on days 1 through 5 of the 6 week cycle for the period of 4 cycles
15961167|NCT03179930|Drug|Entinostat|All patients will receive entinostat 5-7 mg PO as per the dosing regimen at the on D1, D8, and D15
15961168|NCT03179930|Drug|Pembrolizumab|pembrolizumab 200 mg IV on D1
15961169|NCT03179917|Drug|Pembrolizumab|pembrolizumab 200mg IV will be given over 30 minutes on day 1 of each 21 day cycle for a total of 4 cycles
15961170|NCT03179917|Radiation|Involved Site Radiation Therapy|30 Gy of ISRT
15961171|NCT03179904|Drug|Anastrozole|Given PO
15961172|NCT03179904|Drug|Exemestane|Given PO
15961173|NCT03179904|Drug|FASN Inhibitor TVB-2640|Given PO
15961174|NCT03179904|Drug|Fulvestrant|Given IM
15961175|NCT03179904|Other|Laboratory Biomarker Analysis|Correlative studies
15961176|NCT03179904|Drug|Letrozole|Given PO
15961177|NCT03179904|Drug|Paclitaxel|Given IV
15961183|NCT03179839|Behavioral|Mindfulness-based Cognitive Therapy|"The intervention will be carried out according to the handbook of the Dr. Didonna. There is a Session Agenda from Dr. Didonna for the use of the Instructor and session handouts for the participants. Some records of mindfulness practices will be given to participants for facilitating practice between sessions. Before each session, the instructor needs to review the session agenda and prepare copies of handouts for participants.
~MBCT instructors were experienced psychotherapists and psychiatrists with several years' expertise in OCD treatment. They had been trained by one of the founders of MBCT, Mark Williams and the founder of MBCT for OCD, Fabrizio Didonna. Supervision will be provided by Dr.Didonna."
15961184|NCT03179839|Behavioral|Psycho-education Program|As a widely used placebo control condition, the Psycho-Education Program can play an active role through the psychological suggestion and forward thinking mostly. It is designed to be similar with MBCT in level of structure, setting and other non-specific effects of psychological intervention. All instructors will be qualified graduate students who major in clinical psychology with training in cognitive behavioral therapy and psychodynamic therapy.
15961185|NCT03179839|Drug|sertraline, fluvoxamine|The participants can be adjustable once a week dose and the maximum dose does not exceed the maximum amount of instructions. And benzodiazepine drugs also can be used by the OCD patients with sleep disorders, but not be used continuously for more than two weeks. Besides this, other psychotropic drugs are not allowed to use. The use of drugs in this study are commonly used drugs with good safety, and its common adverse reactions include dry mouth, constipation, nausea, indigestion, dizziness, fatigue, sweating and so on.
15961186|NCT03179813|Procedure|Hydrocortisone|During the third molar extraction the hydrocortisone solution will be used in the test group
15961187|NCT03179813|Procedure|Control|During the third molar extraction the saline solution will be used in the control group
15961188|NCT03179800|Device|MobiusHD|The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.
15961189|NCT03179800|Other|Sham Implantation|Sham Implantation
15961190|NCT03179787|Drug|Aripiprazole oral product|oral administration of aripiprazole
15961191|NCT03179774|Device|Endovascular revascularization|All interventions will be performed via 8F femoral sheath. Target common carotid artery will be engaged with 8F JR 4 guiding catheter. Intra-luminal wiring using coronary guidewires and microcatheters or alternative subintimal tracking with antegrade re-entry technique. Wiring would be abandoned after 30 minutes of futile effort, consumption of more than 300 ml of contrast, or when the wire tip is confirmed to be extravascular. Once wire enters distal true lumen, the microcatheter was exchanged to a 1.5 mm diameter coronary balloon for pre-dilatation. Distal embolic protection device would be deployed if an adequate landing zone can be identified. Properly sized balloon expandable stents and self-expanding stents were then deployed to scaffold the occlusion. Balloon post-dilatation may be done if stent expansion was inadequate.
15961192|NCT03179761|Biological|Quadrivalent Inactivated Influenza Vaccine|Given intramuscularly
15961193|NCT03179761|Other|Laboratory Biomarker Analysis|Correlative studies
15961194|NCT03179761|Biological|Trivalent Influenza Vaccine|Given intramuscularly
15961195|NCT03179748|Drug|turoctocog alfa|Patients will be treated with commercially available turoctocog alfa according to local clinical practice at the discretion of the physician
15961196|NCT03179735|Drug|Essential oils|"Patients will be submitted to one-stage ultrasonic debridement to remove plaque, stain(s), and any possible supragingival dental calculus. Further, oral instructions and an oral hygiene kit with fluoride dentifrice, toothbrush and plastic cups marked to indicate the rinse volume will be provided. According to study group, the first rinse will be performed under supervision at the study center and the remaining rinses will be performed unsupervised at home.
~First rinse will be performed 15 days before orthodontic appliances bonding while the last rinse will be performed 6 months after bonding."
15961197|NCT03179735|Drug|Cetylpyridinium Chloride 0.7 mg/ml|"Patients will be submitted to one-stage ultrasonic debridement to remove plaque, stain(s), and any possible supragingival dental calculus. Further, oral instructions and an oral hygiene kit with fluoride dentifrice, toothbrush and plastic cups marked to indicate the rinse volume will be provided. According to study group, the first rinse will be performed under supervision at the study center and the remaining rinses will be performed unsupervised at home.
~First rinse will be performed 15 days before orthodontic appliances bonding while the last rinse will be performed 6 months after bonding."
15961198|NCT03179735|Drug|Placebos|"Patients will be submitted to one-stage ultrasonic debridement to remove plaque, stain(s), and any possible supragingival dental calculus. Further, oral instructions and an oral hygiene kit with fluoride dentifrice, toothbrush and plastic cups marked to indicate the rinse volume will be provided. According to study group, the first rinse will be performed under supervision at the study center and the remaining rinses will be performed unsupervised at home.
~First rinse will be performed 15 days before orthodontic appliances bonding while the last rinse will be performed 6 months after bonding."
15961199|NCT03179722|Behavioral|Medication review|The intervention consists of a medicines use review provided by community pharmacists in Belgium. A medicines use review is a medication review type 2a in which both a patient interview and dispensing data are used as information sources to identify drug-related problems with a specific focus on the medicines use of the patient.
15961200|NCT03179722|Behavioral|Additional data collection: questionnaires|"Pre-post study design.
~At three timepoints, data is collected:
~before the medication review (T-1week)
~during the review (Tweek 3)
~after the review (Tweek12) The questionnaire provide data for the outcomes: medication related quality of life, adherence questionnaire, service satisfaction, use of emergency health services, self-management"
15961201|NCT03179709|Behavioral|Interview|The investigators will perform and analyze semi-structured interviews with enrolled participants.
15961202|NCT03179696|Behavioral|Mobile-assisted CBT|mCBTn combines the CBT components that target defeatist attitudes from Cognitive Behavioral Social Skills Training (CBSST) group therapy and mobile smartphone interventions from our prior clinical trials research.
15961203|NCT03179683|Device|Diode laser application|an 630-660 nm aluminum gallium indium phosphide (AlGalnP) laser device (Scorpion Dental Optima Model 405-7A; Optica Laser, Sofia, Bulgaria) was used immediately after surgery, third day, fifth day and seventh day only for one operation side. Treatment side were randomly selected by another surgeon who applied LLLT. Tissue was irradiated at 25mW power for total six minutes, two minutes for each point (buccal, palatal, crestal). 72J /cm2 energy density was deposited in one session.
15961204|NCT03179644|Other|Measurement of oesophageal pressure and pleural pressure|Measurement of oesophageal pressure by a nasogastric tube with an esophageal balloon (also enabling the patient to be fed) and pleural pressure measurement by means of several pleurocath-type catheters (Prodimed Inc, France) which the thoracic surgeon will have previously Positioned at the end of the surgery without any additional skin intrusion
15961207|NCT03179618|Drug|Anti-Platelet Drugs|Including aspirin and clopidogrel, etc.
15961208|NCT03179618|Drug|Lipid Regulating Drugs|Mainly including statins
15961209|NCT03179618|Drug|Coronary Vasodilator|Mainly including nitrates
15961210|NCT03179618|Drug|Xuefu Zhuyu Decoction|Mainly including Peach Kernel, Safflower, Angelica, Bupleurum etc.
15961211|NCT03179605|Drug|DFD06|Apply twice per day for 15 days
15961212|NCT03179592|Drug|Ultravist 370Mg I/Ml Solution for Injection|Reduced contrast-volume injection protocols based on patient specific tube voltage.
15961213|NCT03179579|Procedure|HIPEC with neoadjuvant chemotherapy|HIPEC 3 times +NACT 2 cycles +CRS +HIPEC 3 times+ ACT 4-6 cycles
15961214|NCT03179579|Procedure|Systemic chemotherapy|NACT 3 cycles +CRS +ACT 4-6 cycles
15961215|NCT03179566|Behavioral|Information Sheet|Patients will receive an informational sheet about how to dispose of leftover opioid medication during discharge. Nurses will provide this information sheet and a brief, scripted description of its use and importance of safe disposal at the time of discharge following surgery.
15961216|NCT03179566|Behavioral|Deterra Drug Deactivation System|This system is a pouch that deactivates prescription drugs, rendering them ineffective for misuse and safe for regular garbage disposal. It uses a patented activated carbon technology to deactivate drugs, including pills, liquids, and patches, and has been found to be 99% percent effective in studies funded by the National Institute of Drug Abuse (NIDA). Additionally, the pouches are made from environmentally friendly materials and contain active ingredients that are considered non-toxic and pose minimal risk, according to their MSDS. Nurses will provide the Deterra bag and a brief, scripted description of its use and importance of safe disposal at the time of discharge following surgery.
15961217|NCT03179540|Procedure|Non-operative management|Patients who are eligible and provide informed consent to participate in the trial will undergo non-operative management (i.e., active surveillance for 24 months) according to the schedule outlined in the study protocol.
15961218|NCT03179527|Drug|Anti-Platelet Drugs|Including aspirin and clopidogrel, etc
15961219|NCT03179527|Drug|Lipid Regulating Drugs|Mainly including statins
15961220|NCT03179527|Drug|Coronary Vasodilator|Mainly including nitrates
15961221|NCT03179527|Drug|Shuanghe Decoction|Mainly including Ginseng, Poria, Calamus, Cyperus, Salvia miltiorrhiza, Radix Polygalae etc.
15961222|NCT03179514|Drug|Anti-Platelet Drugs|Including aspirin and clopidogrel, etc.
15961223|NCT03179514|Drug|Lipid Regulating Drugs|Mainly including statins
15961224|NCT03179514|Drug|Coronary Vasodilator|Mainly including nitrates
15961225|NCT03179514|Drug|Gualou Xiebai Banxia Decoction & Danshen Decoction|Mainly including Fructus Trichosanthis, Rhizoma Pinelliae, Allium, Salvia Miltiorrhiza etc.
15961226|NCT03179501|Drug|NP001|NP001
15961227|NCT03179501|Drug|Placebo|Normal saline
15961228|NCT03179488|Device|Spinal TENS|Spinal TENS stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
15961229|NCT03179488|Device|Sham stimulation|Sham stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
15961230|NCT03179475|Drug|Oxycodone Naloxone Combination|"A flexible dosing schedule will be used in this study. The dose and schedule will be based on the minimal amount of medication required to manage pain related to spinal cord injury. The dose and/or frequency will be titrated to the individual's pain level at the discretion of their regular attending physician and/or investigator.
~Oxycodone-Naloxone is available in the following oral dosages:
~5 mg oxycodone hydrocholoride / 2.5 mg naloxone hydrochloride
~10 mg oxycodone hydrocholoride / 5 mg naloxone hydrochloride
~20 mg oxycodone hydrocholoride / 10 mg naloxone hydrochloride
~40 mg oxycodone hydrocholoride / 20 mg naloxone hydrochloride"
15961231|NCT03179462|Dietary Supplement|Pork intake|Each participant will consume 2 ounces of cooked lean pork.
15961232|NCT03179462|Dietary Supplement|Mixed nuts intake|Each participant will consume 1 ounce of mixed nuts.
15961233|NCT03179462|Dietary Supplement|Tofu intake|Each participant will consume 2 ounces of tofu.
15961234|NCT03179449|Diagnostic Test|Diagnostic (ferumoxytol-enhanced MRI)|Undergo ferumoxytol-enhanced MRI
15961235|NCT03179449|Procedure|Surgery|Undergo surgical resection
15961236|NCT03179449|Drug|Ferumoxytol|Given IV
15961237|NCT03179449|Other|Tissue Analysis|Correlative analysis for macrophage detection and quantification. This applies for all patients in the experimental arm who undergo ferumoxytol infusion.
15961241|NCT03179423|Drug|GNbAC1|Monthly IV repeated dose
15961242|NCT03179423|Drug|Placebo|Monthly IV repeated dose
15961243|NCT03179410|Drug|Avelumab|10 mg/kg intravenously every 2 weeks
15961244|NCT03179397|Device|Model SC9|Experimental
15961245|NCT03179397|Device|Model LI61SE|Active Comparator
15961246|NCT03179384|Drug|Ceftriaxone|ceftriaxone (1g intravenous or 1g/35mL intramuscular) will be given to patients during 7 days
15961247|NCT03179358|Device|C-REX Ring-locking Procedure|"The C-REX Ring-locking Procedure is a method based on adaptive anastomosis, in which intestinal ends adapt to each other after resection due to tumor, injury, or other disease.
~The investigational devices comprised of two components, i.e. C-REX LapAid and C-REX DMH/DMHC"
15961248|NCT03179345|Drug|Gabapentin|
15961249|NCT03179345|Drug|Pregabalin|
15961251|NCT03179332|Drug|BioChaperone® insulin lispro|Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump
15961252|NCT03179332|Drug|Fiasp®|Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump
15961253|NCT03179332|Drug|Novorapid®|Single subcutaneous administration of a bolus of 0.15 U/kg body with a pump
15961254|NCT03179319|Behavioral|MyChoices|Access to the MyChoices mobile app which includes the HIV test plan with reminders, STI information, PrEP resources, links to testing and PrEP sites, and geo-location features.
15961255|NCT03179293|Drug|Propofol|propofol 1 mg/kg IV bolus will be given to the patient with a further 2 mg/kg administered manually over the next 3 min prior to the patient leaving the OR
15961256|NCT03179293|Drug|Normal saline|Normal saline will be administered manually over the next 3 min prior to the patient leaving the OR
15961257|NCT03179280|Drug|insulin|All participants used the rapid-acting insulin analogue aspart (NovoRapid®, Novonordisk A/S, Bagsvaerd, Denmark) and total insulin dose administered to each one for each test meal was known in advance, according to the insulin to carbohydrate ratio that had been calculated during the 2-week pre-study period.
15961258|NCT03179267|Device|SNAP40|SNAP40 ambulatory monitoring device
15961259|NCT03179254|Drug|Metformin continue|Oral hypoglycemic agent continue on the day of ambulatory surgery
15961260|NCT03179254|Drug|Metformin discontinue|Oral hypoglycemic agent discontinue on the day of ambulatory surgery
15961261|NCT03179228|Device|Prostate Embolization|Embolization of the prostate with acrylic polymer microspheres impregnated with porcine gelatin
15961262|NCT03179215|Diagnostic Test|fluid challange|A set of hemodynamic measurements will be obtained at baseline and after infusing a fluid challenge (FC) of 150-250 ml normal saline over 5-10 minutes.Fluid-responders are patients with a SV increase ≥10% after fluid challenge
15961263|NCT03179202|Device|SPRINT Peripheral Nerve Stimulation (PNS) System|"The SPRINT PNS System is a device which delivers mild electrical stimulation to the muscles in the low back. The System includes up to four small wires (called Leads) that are placed through the skin into the muscles in the low back. The wires attach to device(s) worn on the body that deliver stimulation (called Stimulators). The PNS System was approved by the FDA for up to 60 days of use for the management of acute and chronic pain, including back pain."
15961264|NCT03179176|Other|High Frequence Ultrasound Doppler (HFUD) utilisation|Utilisation of HFUD will be done during on patients during an operation in waking condition. This procedure extends the usual procedure from 15 to 20 minutes.
15961265|NCT03179163|Drug|Captopril Pill|ACEi+SH
15961266|NCT03179163|Drug|Enalapril Pill|ACEi
15961267|NCT03179163|Drug|Hydrochlorothiazide|diuretic
15961268|NCT03179150|Diagnostic Test|Computed Tomography|CT scans were performed on a 128 detector rows CT scanner (Somatom Definition Flash Siemens Medical Systems, Erlangen, Germany) as in routine clinical practice in the centre
15961269|NCT03179137|Other|Standard therapy|Patients with therapy prescribed independent of the study
15961270|NCT03179111|Procedure|Pneumoperitoneum Pressure|There will be two arms in this study. The participants recruited for this study are those who have been screened and planned for elective bariatric surgery.The pneumoperitoneum pressure will be adjusted to either 8-10mmHg or 12-15mmHg until a clear operating field is obtained by the surgeon. Low pneumoperitoneum pressure has been expected to give a clearer and better surgical view than standard pneumoperitoneum pressure. Participants under the low pressure group are expected to have lesser pain score on abdominal pain and shoulder tip pain as compared to participants in the standard pressure group.
15961271|NCT03179098|Other|Modified Weeks protocol|The modified Weeks group (GWM) will apply the protocol suggested by Flowers (2002), the positioning will be maintained and at rest will be done electromyographic registers, active goniometry and EVA. Soon afterwards the patients will be submitted to the whirlwind for 20 minutes at a temperature of 41 ° C performing active flexion and elbow extension movements. After the swirl the patients will be submitted to a stretching maintained for 10 minutes with load proportional to the force captured during MVIC according to the pain of the patient. The load will be positioned through a leather device 20 cm from the lateral epicondyle of the elbow.
15961272|NCT03179098|Other|CIVM|Patients underwent electromyographic analysis for the determination of maximal voluntary isometric contraction. The force will be collected for 5 seconds during a CIVM, in which a load cell model MM50 (Kratos, Cotia, SP, Brazil) will be positioned between the floor and the forearm of the volunteer, being coupled to a leather device at 20 cm Make the lateral epicondyle of the elbow. The angle between the forearm and the cable containing a load cell with a 90 degree service.
15961273|NCT03179098|Other|GC- Sustained Stretching|The control group will be applied to sustained stretching, patients will be placed in the supine position with abduction of the shoulder of 30 ° in the plane of the scapula and the forearm in neutral throughout the entire test and the elbow will be supported in a towel to avoid discomfort And compression in the region of the olecranon.
15961274|NCT03179085|Behavioral|Home-Based Kidney Care|All subjects randomized to the HBKC arm will be visited by a community health representative in their home at least every two weeks for the duration of the 12 month intervention. Each visit will last 30 minutes to one hour and cover materials like, (1) Kidney 101, (2) weight management, (3) exercise, (4) healthy eating, (5) medication management, (6) coping with stress, (7) risk factor management (i.e.- blood pressure, hyperlipidemia), (8) alcohol and substance abuse, (9) smoking cessation, and related health concerns.
15961275|NCT03179059|Diagnostic Test|Pregnancy test at Baseline|Among respondents who are randomly selected to receive a free home pregnancy test service, they will be offered the chance to take the test in the presence of the enumerator. Specifically, this would mean they would be given a cup to collect a sample of urine. The respondent would do so privately, then bring the cup back to the enumerator who would dip the home pregnancy tests and assist with interpreting the result. However, respondents can decline to take the test with the enumerator. Treatment assignment will be stratified by whether respondent use modern family planning at baseline.
15961276|NCT03179059|Diagnostic Test|Pregnancy test at follow up survey|We will provide a free pregnancy tests in for the future use, they are randomly selected from intervention #1 treatment group.
15961277|NCT03179046|Diagnostic Test|Laboratory tests and cardiac imaging|Laboratory tests (blood count, liver and kidney functions, antibodies, acute phase reactants), Echocardiography and gadolinium enhanced cardiac MRI
15961363|NCT03178357|Other|Standard therapy|Standard treatment according to current guidelines and outpatient visits with psychological and / or psychoeducational counseling
15961278|NCT03179020|Other|Checklist use|Management of the potential donor guided by the use of an evidence-based checklist. This checklist is based on main recommendations of the Brazilian guideline for the management of potential multiple organ donors.
15961279|NCT03179020|Other|Usual care|Management of the potential donor according usual care.
15961280|NCT03179007|Biological|Anti-CTLA-4/PD-1 expressing MUC1-CAR-T|Every cycle, peripheral blood mononuclear cells (PBMC) are collected on day 0, CAR-T cells are cultured in a GMP standard workshop. Patients are given a three-day regimen of chemotherapy consisting of cyclophosphamide aimed to deplete the lymphocytes before cells infusion. Then the patients will receive an i.v.gtt infusion of CTLA-4 and PD-1 antibodies expressing MUC1 targeted CAR-T cells at (2-5) ×10^7 cells/kg from day 18 to day 19 (±2 days). 2 cycles are regarded as a treatment period.
15961281|NCT03178994|Drug|2% ketoconazole cream|2% ketoconazole cream applies twice daily
15961282|NCT03178994|Drug|Hydrophilic Cream|Hydrophilic cream (in-house preparation) applies twice daily
15961283|NCT03178981|Other|Use electronic cigarette or smoke conventional cigarette|Use of electronic cigarette or smoking conventional cigarette ad libitum for 5 minute period
15961284|NCT03178968|Other|Orange juice|3 immersion times in orange juice were investigated
15961285|NCT03178955|Drug|Etanercept|Circadian activity rhythm parameters will be evaluated for 7 days prior to Enbrel treatment through 7 days after initiation of Enbrel treatment and again 28-35 days after the second Enbrel treatment.
15961286|NCT03178942|Drug|Permethrin Cream, 5%|Permethrin Cream 5%
15961287|NCT03178942|Drug|Elimite™ Cream (permethrin) 5%|Permethrin Cream 5%
15961288|NCT03178929|Drug|S-Adenosyl Methionine|2000mg, po
15961289|NCT03178903|Other|tDCS|Participants in transcranial direct current stimulation (tDCS) will receive tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks.
15961290|NCT03178903|Other|Sham tDCS|Participants in sham transcranial direct current stimulation (tDCS) will receive shame tDCS over the dorsal-lateral prefrontal cortex for 20 minutes, 3 times per week for 8 weeks.
15961291|NCT03178903|Behavioral|Aerobic Exercise (AE)|Participants will engage in supervised, 30-minute bouts of moderate-intensity exercise 3x/week for 8 weeks.
15961292|NCT03178890|Device|OHMG|Device will be implanted in all enrolled patients.
15961293|NCT03178877|Other|No intervention|
15961294|NCT03178864|Drug|Rivaroxaban|Rivaroxaban 20 mg daily (15 mg daily in participants with a CrCl 30-49 mL/min as per the Cockroft-Gault equation)
15961295|NCT03178864|Drug|Standard of care|Accepted standard of care as per American Heart Association/American Stroke Association Guidelines (initial use of unfractionated heparin or low-molecular weight heparin with transition to an oral vitamin K antagonist or continuation with low-molecular weight heparin) with choice of agent at the treating physician's discretion.
15961296|NCT03178851|Biological|Atezolizumab|Atezolizumab, 840 mg intravenously every two weeks (Q2W) on Days 1 and 15 of each 28-day cycle, until loss of clinical benefit
15961297|NCT03178851|Drug|Cobimetinib|Cobimetinib, 60 mg orally once daily (QD) on Days 1-21 of each 28-day cycle, until loss of clinical benefit
15961298|NCT03178851|Biological|Atezolizumab|Atezolizumab, 840 mg intravenously on Day 15 of Cycle 1; thereafter Q2W on Days 1 and 15 of Cycle 2 and all subsequent 28-day cycles, until loss of clinical benefit
15961299|NCT03178851|Biological|Atezolizumab|Atezolizumab, 1200 mg intravenously every three weeks (Q3W) on Day 1 of each 21-day cycle, until loss of clinical benefit
15961300|NCT03178825|Device|Hybrid Fractional Laser|Consecutive and coincident fractional 2940 nm and 1470 nm lasers
15961301|NCT03178812|Procedure|EUS with fine-needle aspiration of pancreatic cyst|EUS with fine-needle aspiration
15961302|NCT03178812|Diagnostic Test|Laboratory Blood test|Laboratory Blood Test
15961303|NCT03178786|Behavioral|PAT sessions|PD subjects will be tested twice, that is, within four weeks before (Baseline) and after the completion of 9 PAT projects (Follow up).
15961304|NCT03178773|Behavioral|TExT-MED|messages designed to inspire motivation and behavior change
15961305|NCT03178773|Behavioral|FANS|SMS delivered messages to family members to improve social support
15961306|NCT03178760|Diagnostic Test|Ultrasonic Measurement will be taken from optic nerve sheat diameter and compared-classified.|"Ultrasonic Measurement will be taken from optic nerve sheat diameter and compared-classified. Classifications will be done for;
~Age
~Gender
~Weight
~Length
~Waist Circumference
~Body mass index"
15961307|NCT03178747|Diagnostic Test|Methylene blue|working solution methylene blue
15961308|NCT03178747|Diagnostic Test|Giemsa stain|working solution Giemsa stain (Wolbach's modification)
15961309|NCT03178734|Device|Foley Catheter vs Self-Contained Valved Catheter|This study aims to compare UTI rates and patient satisfaction between an indwelling Foley catheter group (established SOC); and a relatively (FDA-approved) new valved addition to the Foley catheter which requires no drainage bag.
15961310|NCT03178721|Diagnostic Test|blood sample|study B regulatory in blood and its correlation with atherosclerosis
15961311|NCT03178708|Drug|Group A amantadine sulfate|infusion solution for slowly intravenous application 3 hours preoperative
15961312|NCT03178708|Other|Group B ringer lactate|infusion solution for intravenous application 3 hours preoperative
15961313|NCT03178695|Other|Autologous PRP injection into human ovarian tissue|Using FDA-approved equipment, blood plasma is received from participant, isolated/enriched into PRP, and infused into the ovaries under transvaginal ultrasound guidance.
15961314|NCT03178682|Diagnostic Test|ultrasound parameters|ultrasonographic parameters (mean gestational sac diameter, yolk sac diameter, crown rump length, embryonic heart rate and uterine artery Doppler) in predicting early pregnancy failure in patients with recurrent pregnancy loss.
15961315|NCT03178669|Drug|cobitolimod|Rectal administration
15961316|NCT03178669|Drug|Placebo|Solution manufactured to mimic cobitolimod
15961317|NCT03178656|Drug|Sorafenib|continuous application of the drugs
15961318|NCT03178656|Procedure|surgery|curative resection
15961319|NCT03178643|Drug|Proguanil Oral Tablet|Dosing of daily proguanil will be approximately 3mg/kg/day,
15961320|NCT03178643|Drug|Sulfadoxine/Pyrimethanine-Amodiaquine (SP-AQ)|Age 1-5 on Day 1: One tablet 500/25mg SP and one tablet 153mg AQ Day 2 and Day 3: one tablet 153 mg AQ only each day For ages 6-10: Day 1 - 1.5 tablets 500/25mg SP and 1.5 tablets 153mg AQ Days 2 and 3: 1.5 tablets 153mg AQ only each day
15961986|NCT03173547|Drug|146-9251 cream|146-9251 cream contains an active drug and is applied topically.
15961321|NCT03178643|Drug|Dihydroartemisinin-Piperaquine (DP)|"3) The weight-based dosing of tablets of 40/320mg of DP is described below:
~Weight (kg) No. of 40/320mg tabs DP daily for 3 days
~≤ 5 ¼ 6-10 ½ 11-14 ¾ 15-19 1 20-23 1 ¼ 24-25 1 ½"
15961322|NCT03178617|Other|Educational Intervention|Attend standard of care LIP
15961323|NCT03178617|Other|Educational Intervention|Attend HIP
15961324|NCT03178617|Other|Quality-of-Life Assessment|Ancillary studies
15961325|NCT03178617|Other|Questionnaire Administration|Ancillary studies
15961326|NCT03178604|Other|Classic massage|It involves applying the classic massage techniques: effleurage (gliding or sliding movement over the skin with a smooth continuous motion following the direction of the muscle fibers of the superficial muscles in a distal to proximal direction); petrissage (lifting, wringing, or squeezing of soft tissues in a kneading motion, or pressing or rolling of the tissues under or between the hands); tapotement (various parts of the hand striking the tissues at a fairly rapid rate). The general objective is to improve extensibility of muscle, tendon, fascia, joint capsule, and ligamentous structures.
15961327|NCT03178604|Other|Sham massage|This group received a placebo intervention at the same time as the other group, maintaining only soft touch with the participant without exerting any mechanical pressure.
15961328|NCT03178591|Drug|vildagliptin|
15961329|NCT03178591|Drug|Dapagliflozin|
15961330|NCT03178565|Other|Mechanical insufflation-exsufflation|The mechanical insufflation-exsufflation device will be connected in the orotracheal tube. Four series of insufflation-exsufflation will be conducted. Each serie will be composed by 10 cycles of alternated insufflation (40 cmH2O) and exsufflation (- 40 cmH2O).
15961331|NCT03178565|Other|Standard Respiratory Physiotherapy|Standard chest physiotherapy will be conducted through bilateral thoracic maneuvers (percussion and vibration) followed by manual hyperinflation using a manual resuscitator bag.
15961342|NCT03178539|Drug|diclofenac|non steroidal anti-inflammatory drug
15961343|NCT03178539|Drug|ketorolac|non steroidal anti-inflammatory drug
15961344|NCT03178526|Drug|Lovastatin gel|Lovastatin gel1.2% topical gel was put into teh periodontal pocket using an insulin syringe
15961345|NCT03178526|Drug|Placebo|placebo gel
15961346|NCT03178513|Other|Home visit|"The visit will be entirely patient tailored, last approximately one hour, and at a minimum will entail:
~Medical assessment
~Psychosocial assessment
~Medication reconciliation
~Follow-up of inpatient primary team's specific recommendations
~Follow-up, as needed, with primary care team or inpatient team"
15961347|NCT03178500|Drug|Clomiphene Citrate 50mg|stair-step clomiphene adminstration
15961348|NCT03178487|Drug|Upadacitinib|Tablet
15961349|NCT03178487|Drug|Placebo|Tablet
15961350|NCT03178474|Other|JINLINGGUAN Infant formula,PRO-KIDO™ I-PROTECH®|JINLINGGUAN Infant formula,PRO-KIDO™ I-PROTECH®: a type of Phase I infant formula for 0-6 month infants, with a trademark of PRO-KIDO™ I-PROTECH®. The formula contains both OPO structured lipid and α+β patented protein (patent number: ZL200810241156.3).It was produced by Inner Mongolia Yili Industrial Group Co.Ltd.,China
15961351|NCT03178474|Other|TOFER Infant formula,TOFER®|TOFER Infant formula,TOFER®: a type of Phase I infant formula for 0-6 month infants, with a trademark of TOFER®. The formula was characterized by (1) Moderate digestible small-molecule protein; and (2) BID® complex probiotics. It was produced by Inner Mongolia Yili Industrial Group Co.Ltd.,China
15961352|NCT03178474|Other|Breast milk|Breast milk: Human breast milk, provided and fed by the corresponding infant's mother
15961353|NCT03178461|Other|Body temperature parenteral fluids|2 study groups shall receive the same parenteral fluids but at different temperatures.
15961354|NCT03178435|Other|Measures to prevent AKI among critically ill patients|"Meticulous optimization of the fluid balance
~Avoidance of nephrotoxic medications where possible
~Optimisation of the hemodynamic status
~Avoidance of blood transfusion unless marked acute blood loss or symptomatic anemia
~Optimization of the underlying medical condition
~Seek expert renal advise when necessary"
15961355|NCT03178422|Drug|CQSS2|Nicotine Replacement Therapy
15961356|NCT03178422|Drug|NicoDerm CQ Patch|Nicotine Replacement Therapy
15961357|NCT03178409|Procedure|Hepatectomy|Removal of a part of the liver
15961358|NCT03178396|Dietary Supplement|melatonin|controlled release, 9 mg taken 30 minutes before bedtime x 6 weeks
15961359|NCT03178383|Behavioral|Project HEAL|Standard group churches will not be asked to, or provided special encouragement to technical assistance with, institutionalizing health promotion activities in their churches.
15961360|NCT03178383|Behavioral|Project HEAL 2.0|In this approach, rather than developing a separate health ministry, cancer activities could be integrated throughout existing church ministries (e.g. men's, women's, seniors).
15961361|NCT03178370|Device|Gastric Electrical Stimulation|Temporary and permanent gastric electrical stimulation
15961362|NCT03178357|Other|Cardiac rehabilitation + standard therapy|Patients with HCM subjected to cardiological rehabilitation
15961364|NCT03178344|Device|XCSITE100 Stimulator tACS|Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.
15961365|NCT03178344|Device|XCSITE100 Stimulator Sham|The participant will receive up to one minute of tACS stimulation until the stimulation fades. Sham stimulation mimics the skin sensations a participant would experience during a tACS session.
15961366|NCT03178331|Other|Study questionnaires|filled by parents, school nurse and teacher
15961367|NCT03178318|Procedure|ultrasound|ultrasound of the neck to identify the position of upper and lower border of the cricothyroid membrane.
15961368|NCT03178305|Behavioral|Do CHANGE|"Besides the behavior change programme (Do Something Different)
~All patients will receive: Fitbit, Beddit, Care-portal, Do CHANGE app (including dietary habits picture taking), CookiT (smart spatula that monitors cooking behavior)
~patients with heart failure will, in addition to the above mentioned, be offered a weight scale, blood pressure monitor, and FluiT (smart cup to measure fluid intake).
~Patients with hypertension will also be offered a bloodpressure monitor.
~Data from these devices will be gathered and visible for patients (in patient portal) and for their health care provider (health care provider portal). In case of negative results the patient will be contacted by their health care provider (usually the cardiologist).
~Once every week the patients will be contacted to discuss their progress and will be given feedback about their dietary intake."
15961369|NCT03178292|Drug|Levofloxacin|Levofloxacin 500Mg daily for 5 days
15961370|NCT03178292|Drug|Placebo|Placebo Oral Tablet daily for 5 days
15961371|NCT03178279|Other|Physical Health Plan|Use of a Physical Health Plan by service users
15961372|NCT03178266|Device|Knee Arthroplasty|Standard Knee Arthroplasty will be performed on study subjects. The closure method will be studied at 3 weeks and 6 weeks and patients will be asked about satisfaction with the closure method assigned.
15961373|NCT03178240|Behavioral|photoaging mirroring intervention|selfies of the students are photoaged showing them the consequences of their UV protection behavior on their own face
15961374|NCT03178227|Behavioral|Photoaging Mirroring Intervention|"Medical students perform mirroring with the pupils in the schools where they shoot selfies with tablets and photoage them to future non-smokers vs. future smokers."
15961375|NCT03178214|Drug|Infacort|Immediate-release multiparticulate formulation of hydrocortisone.
15961376|NCT03178201|Drug|TGR-1202|Treatment will be self-administered on an outpatient basis. Patients will take TGR-1202 800 mg, oral, one tablet daily on a continuous basis. Each cycle lasts 28 days.
15961377|NCT03178188|Device|Pulsed-dye Laser|595 nm Pulsed-dye Laser; 7mm spot sizes, 6msec pulse durations, 8j/cm2 fluences, dynamic cooling device 30/20, 4 sessions with 4 weeks interval
15961378|NCT03178188|Device|Sham|Cryogen spray with the setting of dynamic cooling device 30/20
15961379|NCT03178175|Procedure|Acupuncture|"In the acupuncture with De Qi group, using stainless tiny needles is inserted to the specific acupoints over the scalp (Si Shen Cong and Baihui) until the De Qi phenomenon occurs. The duration is about 30 minutes, and all patients will receive the procedure 16 times within 2 months."
15961380|NCT03178175|Procedure|Needle Insertion|"In the Sham acupuncture group, using stainless tiny needles is inserted to the specific acupoints over the scalp (Si Shen Cong and Baihui) but the needle doesn't reach the exact depth and De Qi phenomena doesn't occur. The duration is about 30 minutes, and all patients will receive this procedure 16 times within 2 months."
15961381|NCT03178149|Drug|ASP7317|subretinal injection
15961382|NCT03178149|Drug|tacrolimus|oral
15961383|NCT03178123|Biological|humanized anti-PD-1 monoclonal antibody Toripalimab|humanized anti-PD-1 monoclonal antibody (JS001) is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically.
15961384|NCT03178123|Biological|high-dose recombinant interferon a-2B|15*10^9 U/m2/d recombinant interferon a-2B intravenously on days 1-5 weekly for 4 weeks.Then 15*10^9 U/m2/d recombinant interferon a-2B intravenously three times weekly for 48 weeks.
15961385|NCT03178110|Behavioral|Physical therapy and dynasplint|Participants will receive a session of 30-45 minutes of manual therapy two times per week, for eight weeks. All participants will be instructed how to use the Dynasplint® Trismus System at home. Participants will start the use of the DTS for 10-30 minutes three times per day, every day. If the exercises are well tolerated, time will be progressively increased to 30 minutes and then intensity (force) will be increased.
15961386|NCT03178084|Drug|Maraviroc (UK-427,857) QD + Zidovudine/Lamivudine BID|maraviroc (UK-427,857) 300 mg once daily added to zidovudine/lamivudine (300 mg/150 mg twice daily
15961387|NCT03178084|Drug|Efavirenz QD + Zidovudine/Lamivudine BID|efavirenz (600 mg once daily) added to zidovudine/lamivudine (300 mg/150 mg twice daily)
15961388|NCT03178084|Drug|Maraviroc (UK-427,857) BID + Zidovudine/Lamivudine QD|maraviroc (UK-427,857) 300 mg twice daily added to zidovudine/lamivudine (300 mg/150 mg twice daily
15961389|NCT03178071|Drug|Lorlatinib|oral tablets, administered daily, continuously
15961390|NCT03178058|Other|Questionaire|"Prior to surgery women will be given a questionnaire detailing previous motion sickness, previous history of PONV, emesis during pregnancy, smoking history , itching history, skin atopy and allergies. After surgery details about surgery will be added: intraoperative hypotension, use of phenylepherine, intraoperative nausea and vomiting, exteriorization of uterus, extent of adhesions, need for uterotonic medications, and estimated bleeding.
~Parturients will be assessed 1 hour and 24 postoperatively by attending anesthesiologist, PONV incidence will be reported using a three point ordinal scale (0 = none, 1 = nausea, 2 = retching, 3 =vomiting)."
15961391|NCT03178045|Other|Team Monitoring|In this cohort, the electronic system will provide advanced informatics support for push notifications to the care team based on the severity of the symptoms reported. This platform promotes early detection and intervention. The care team is alerted when patients experience symptoms out of the expected range or if symptoms are worsening. Nurses receive secure message notifications and will contact the patient by phone depending on symptom severity. If a patient responds with a moderate-severe answer, the office team gets an alert and calls the patient during business hours.
15961434|NCT03177681|Device|Holter Monitor|Participants wear a Holter monitor for 20-24 hours to check nervous system and heart function at baseline and once during Days 3-7 and once during Days 8-12.
15961392|NCT03178045|Other|Enhanced Feedback|In this cohort, the electronic system will provide tailored normative data visualizations that offer context and education to patients regarding expected symptom severity. The information provided to patients in the Enhanced Feedback group will be procedure specific and based on continuously updated PRO-CTCAE data from previous patients. Patients are thus able to see their own recovery trajectory relative to that of patients who have undergone the same procedure. Care is patient activated in that patients will use the information about expected symptoms to decide whether they should call the care team (e.g., if they are experiencing symptoms that are more severe or more prolonged than expected). If a patient reports severe symptoms, they are instructed to immediately contact their physician's office or seek medical attention.
15961393|NCT03178032|Biological|DNX-2401|Brain infusion of the virus through the cerebellar peduncle
15961394|NCT03178019|Other|Laser-Doppler methods|This was a cross-sectional study in which participants were subjected to a screening phase before being eligible to participate in the study. All subjects were submitted to Laser-Doppler methods (assessment of microcirculatory blood flow), bioimpedance analysis (assessment of body composition), venous blood collections (laboratory analysis), and Finometer Pro (assessment of heart rate variability and blood pressure variability).
15961395|NCT03177993|Drug|3 drug dose - IDA|"Lymphatic Filariasis Mass Drug Administration (MDA) with triple drug therapy of ivermectin, diethylcarbamazine, and albendazole (IDA). Participants excluded from ivermectin will receive a topical dose of permethrin cream.
~Exclusion criteria for ivermectin, diethylcarbamazine and albendazole:
~severe illness (chronic renal insufficiency, severe chronic liver disease, or any illness that is severe enough to interfere with activities of daily living);
~allergy to ivermectin, diethylcarbamazine or albendazole;
~pregnant;
~breastfeeding within 7 days of delivery;
~less than 2 years old; OR
~less than 15 kg
~In addition if less than 5 years old excluded from ivermectin.
~Exclusion criteria for permethrin:
~allergy to permethrin
~crusted scabies"
15961396|NCT03177993|Drug|3 drug dose - IDA with second dose of ivermectin|"Lymphatic Filariasis Mass Drug Administration (MDA) with triple drug therapy of ivermectin, diethylcarbamazine, and albendazole (IDA). Eight days after treatment participants will be given a second dose of ivermectin alone.
~Participants excluded from ivermectin will receive a topical dose of permethrin cream both on day 0 and day 8.
~Exclusion criteria for ivermectin, diethylcarbamazine and albendazole:
~severe illness (chronic renal insufficiency, severe chronic liver disease, or any illness that is severe enough to interfere with activities of daily living);
~allergy to ivermectin, diethylcarbamazine or albendazole;
~pregnant;
~breastfeeding within 7 days of delivery;
~less than 2 years old; OR
~less than 15 kg
~In addition if less than 5 years old excluded from ivermectin.
~Exclusion criteria for permethrin:
~allergy to permethrin
~crusted scabies"
15961397|NCT03177993|Drug|2 drug dose - DA|"Lymphatic Filariasis Mass Drug Administration (MDA) with the currently used standard of care combination drug therapy of diethylcarbamazine, and albendazole (DA).
~If scabies is present in the participant or a household member permethrin cream will be provided 8 days after dose of DA.
~Exclusion criteria for diethylcarbamazine and albendazole:
~severe illness (chronic renal insufficiency, severe chronic liver disease, or any illness that is severe enough to interfere with activities of daily living);
~allergy to diethylcarbamazine or albendazole;
~pregnant;
~breastfeeding within 7 days of delivery;
~less than 2 years old; OR
~less than 15 kg
~Exclusion criteria for permethrin:
~allergy to permethrin
~crusted scabies"
15961398|NCT03177980|Drug|Fentanyl|The dosing and administration of fentanyl will serve as the first drug intervention in infants in need of analgesia according to an algorithm based on pain scoring results.
15961399|NCT03177980|Drug|Fentanyl and clonidine|In infants in need of further analgesia clonidine will be administered as an add on drug according to an algorithm based on pain scoring results.
15961400|NCT03177967|Behavioral|Sleep Restriction Therapy/Stimulus Control|Sleep Restriction Therapy focuses on forcing your available sleep time into a fixed window. The sleeper sets a bedtime and wake-up time and sticks to those times closely. The time allocated for being allowed in bed is determined from an estimate of how long the patient in average has been sleeping during the night, in the week before treatment. The goal is to have the patient sleeping the entire time he or she is in bed by making this period so restricted that the patient has no chance of sleeping enough. Once this goal is achieved, the time allocated for bed can be slowly increased, for example by 15 minutes at a time. After enough iterations, an equilibrium is achieved that the patient can keep maintaining after treatment has completed.
15961401|NCT03177967|Other|Discussions about adverse cognitions about sleep|Group discussions about insomnia, CBT-i treatment and it's effects
15961402|NCT03177967|Other|Psychoeducative advice about how to improve sleep|Learning about sleep and sleep hygiene tips. It also includes learning about stimulus control and sleep restriction.
15961403|NCT03177954|Behavioral|Patient Oriented Discharge Summary|Participants will undergo a Patient Oriented Discharge Summary (PODS). The PODS is a personalized summary of the discharge plan presented in an easy to understand worksheet that covers (1) medication instructions; (2) follow-up appointments with phone numbers; (3) normal expected symptoms, warning signs, and what to do if they experience a problem; (4) lifestyle changes and when to resume activities; and (5) information and resources to have handy. The meeting will take place one week prior to discharge.
15961404|NCT03177941|Other|Eviderma Smart Phone Teledermatology Application (Eviderma)|First-degree relatives download a mobile application onto their smart phone (n=150). This is the skin self-examination training intervention used in the original RCT (MoleScore). Participants will perform a Skin Self-Examination with partner assistance each month during the study. Participants will take a picture of one of their moles using their smart phone and upload to the application one image of a mole/freckle with a decision about their mole/freckle.
15961405|NCT03177928|Device|Transthorathic echocardiogram|In echocardiography lab and using transthoracic echocardiogram to reveal any cardiac changes in patients.
15961406|NCT03177915|Drug|Hylase|median nerve hydro-dissection using Hyalase + 10 cc saline injection
15961407|NCT03177915|Drug|Saline|median nerve hydro-dissection using 10 cc saline injection
15961408|NCT03177902|Drug|Chemotherapy|Newly diagnosed breast cancer patients undergoing at least four cycles of chemotherapy.
15961433|NCT03177681|Behavioral|Questionnaires|Participants complete 4 questionnaires about symptoms in the past 24 hours, irritable bowel syndrome (IBS), most recent stool, and quality-of-life. Questionnaires completed at baseline and once during Days 3-7 and once during Days 8-12. Questionnaires should take about 30 minutes total to complete.
15962155|NCT03172325|Drug|Methotrexate|15 mg Methotrexate is weekly administered to all the patients.
15961409|NCT03177889|Combination Product|Traditional Chinese Medicine (TCM)|"Traditional Chinese Medicine plus oral mucolytics [ambroxol 30mg tid, or N-acetylcysteine 0.2g tid, serrapeptase 10mg tid, or carbocisteine 500mg tid];
~Agastache rugosus 5g, Scutellaria baicalensis 10g, Radix Puerariae 10g, Acorus tatarinowii schott 10g, Fructus Liquidambaris 5g, gypsum 15 g, Rheum officinale 5 g, Folium sennae 5 g, Codonopsis pilosula 10g, Radix Salviae Miltiorrhizae 10g, Lignum millettiae 10 g, Liquiritia glycyrrhiza 10 g
~Optional formulae: bile arisaema 15g, polygala tenuifolia 15g, Mangnolia officinalis 10g, Fructus aurantii immaturus 10g; Magnetite 15-30g and reddle15-30g"
15961410|NCT03177876|Procedure|sinus lift implant placement Hydroxyapatite Nano particles|shneiderian membrane elevation and augmentation with Hydroxyapatite Nano particles with simultaneous implant placement
15961411|NCT03177876|Procedure|sinus lift implant placement tenting|shneiderian membrane elevation and augmentation with graft less tenting technique with simultaneous implant placement
15961412|NCT03177863|Procedure|Expectancy|Clinical monitoring. See arm description
15961413|NCT03177850|Drug|ACETAZOLAMIDE oral capsule|Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m
15961414|NCT03177850|Drug|Placebo oral capsule|Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m
15961415|NCT03177837|Drug|ACETAZOLAMIDE oral capsule|Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m
15961416|NCT03177837|Drug|Placebo oral capsule|Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m
15961417|NCT03177824|Drug|Sildenafil Citrate 25Mg Tab|Group 1, consists of 30 patients who will receive Sildenafil citrate (25mg) tab (Silden, Epico, Egypt) 3times daily till the time of delivery, followed by repeating the Doppler US scan serially to detect changes in the measured indices and then assess the neonatal outcome after delivery as regard birth weight and APGAR score.
15961418|NCT03177824|Drug|Placebo Oral Tablet|Group 2, consists of 30 patients receiving placebo Oral Tablet 3times daily , followed by repeating the Doppler US scan serially to detect changes in the measured indices and then assess the neonatal outcome after delivery as regard birth weight and APGAR score
15961419|NCT03177811|Drug|ACETAZOLAMIDE oral capsule|Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m
15961420|NCT03177811|Drug|Placebo oral capsule|Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m
15961421|NCT03177798|Drug|Icatibant|Subjects will receive either Icatibant or placebo in the first study day. After a washout period of 3 weeks, participant will receive the other treatment. Icatibant (50µg/kg/h) or placebo will be infused for 1 hour prior to the initiation of dialysis and continue through hemodialysis. Hemodialysis session will last approximately 4 hours. Two hours after the end of hemodialysis, The investigators will evaluate mitochondrial function by 31 phosphorus magnetic resonance spectroscopy.
15961422|NCT03177798|Drug|Placebo|Subjects will receive either Icatibant or placebo in the first study day. After a washout period of 3 weeks, participant will receive the other treatment. Icatibant (50µg/kg/h) or placebo will be infused for 1 hour prior to the initiation of dialysis and continue through hemodialysis. Hemodialysis session will last approximately 4 hours. Two hours after the end of hemodialysis, the investigators will evaluate mitochondrial function by 31 phosphorus magnetic resonance spectroscopy.
15961423|NCT03177785|Behavioral|EverydayMatters|
15961424|NCT03177772|Behavioral|Pre-loss group therapy|The PLGT intervention will include CGGT treatment elements modified to address the pre-loss preparation of caregivers at risk for complicated grief, and will focus on the perceived relationship and attachment status between caregiver and care recipient, how memories of the life together, the illness and the death are interpreted, and strategies for preparing for life without the care recipient. These activities include elements of motivational interviewing, cognitive behavioral therapy and prolonged exposure therapy.
15961425|NCT03177746|Drug|Dapoxetine/Tadalafil 30/20 mg film coated tablet|"During 4-weeks treatment period, patients will take one Dapoxetine/Tadalafil 30/20 mg film coated tablet 1-3 hours before sexual intercourse.
~Study drug should not be used more than 1 tablet every 24 hours during the treatment."
15961426|NCT03177733|Procedure|Evaluation of a breast double block|"we made an association of the serratus block and the PIF block, which allows for a complete block of both the laterals branches of intercostal nerves (with the serratus block) and of anterior branches of intercostal nerves (with the PIF block). Therefore, this association of blocks may lead to a complete analgesia of the breast, while the serratus block alone only allows for an analgesia of the lateral part of the breast.
~The objective is to analyze this technique through a collection form that evaluates the satisfaction and post-operative morphine consumption of women receiving this association before a general anesthesia for a unilateral mastectomy with homolateral total lymphadenectomy.
~This is a purely observational study that assesses our current practice in this type of surgery."
15961427|NCT03177720|Drug|Ciprofloxacin|Ciprofloxacin 400mg will be administered as single dose infusion over 60 minutes, imipenem/cilastatin 1000mg as single intravenous dose applicated over 60 minutes.
15961428|NCT03177720|Drug|Imipenem|Ciprofloxacin 400mg will be administered as single dose infusion over 60 minutes, imipenem/cilastatin 1000mg as single intravenous dose applicated over 60 minutes.
15961429|NCT03177707|Other|Mindfulness-based Therapy Group for Couples|"Eligible couples will take part in a 4-session mindfulness-based therapy group for couples. The groups will last 2 hours in length, for a total of 8 hours of treatment time, and sessions will be scheduled once per week in successive weeks.
~The groups will have one highly experienced female facilitator, who is the Study Coordinator. The facilitator led the design of the treatment manual, and has experience in facilitating similar groups. The facilitator will follow a detailed, empirically-informed mindfulness-based treatment manual that was designed for the purpose of this study. All groups will take place in a private group treatment room at Vancouver General Hospital."
15961430|NCT03177694|Device|Wireless bed sensor|Remote data collection
15961431|NCT03177681|Other|Tongue Assessment|The coating on the top of the tongue assessed and categorized into three categories: no coating, thin coating and thick coating. The coating of the tongue may be related to the microorganisms in the intestine.
15961432|NCT03177681|Other|Stool Sample|Stool sample collected at baseline and once during Days 3-7 and once during Days 8-12.
15962156|NCT03172325|Drug|Folic Acid|At least 1 mg Folic acid is daily administered to all the patients.
15961435|NCT03177681|Other|Yogurt|Participants given 2 tablespoons (33 cc) of DannonÒ OikosÒ yogurt each day for 12 days.
15961436|NCT03177668|Drug|YS110|Intravenous administration
15961437|NCT03177655|Other|Guided Imagery|Guided Imagery meditation
15961438|NCT03177655|Other|Journaling|Keeping a journal
15961439|NCT03177629|Drug|treatment : H. pylori eradication|"treatment: H. pylori eradication (pantoprazole, amoxicillin, clarithromycin, metronidazole) to treatment group at visit 1 and to control group 2nd stage at visit 4.
~Day 1-5: pantoprazole 40mg bid, amoxicillin 1000mg bid, PO Day 6 - 10: pantoprazole 40mg bid, clarithromycin 500mg bid, metronidazole 500mg tid, PO"
15961440|NCT03177616|Other|Chiropractic Treatment|"The treatment plan will be customized to the patient's needs. The chiropractic interventions are summarized as follows:
~posture correction/spinal stabilization exercises
~soft tissue relaxation techniques
~spinal manipulation (i.e. chiropractic adjustment)/mobilization
~breathing and relaxing techniques
~stretches, self-care
~ergonomic modifications
~bracing and supports"
15961441|NCT03177603|Drug|GSK2586881|GSK2586881 is a clear colorless liquid for IV infusion over 3- 5 minutes and will be administered a maximum dose of 0.8 mg/kg.
15961442|NCT03177590|Other|Recordings of facial and vocal emotional productions|"Children are asked to perform three tasks:
~an emotional production on imitation (the child with autism or TED will imitate the emotion expressed by an animated avatar)
~an emotional production by mime of the emotion on command (oral and written) without visualizing the model of imitation
~Emotional production in context: the child with autism or EFD will describe images forming the story of Frog and as it is read, will produce the appropriate facial and vocal emotions in the context."
15961443|NCT03177577|Device|Splint|Subjects will use a splint custom-made by Massachusetts General Hospital Occupational Therapists as part of standard care for treatment of carpometacarpal (CMC) osteoarthritis.
15961444|NCT03177577|Device|Splint with strengthening exercises|Subjects will use a splint custom-made by Massachusetts General Hospital Occupational Therapists as part of standard care for treatment of carpometacarpal (CMC) osteoarthritis and will also be taught two first dorsal interosseous (FDI) strengthening exercises.
15961445|NCT03177564|Procedure|Protective ventilation 1|Low tidal volume, high inspired oygen fraction (FiO2) and recruitment maneuver.
15961446|NCT03177564|Procedure|Protective ventilation 2|Low tidal volume, PEEP, moderate inspired oygen fraction (FiO2) and recruitment maneuver.
15961447|NCT03177564|Procedure|Driving Pressure Limited Ventilation|Positive end expiratory pressure is adjusted to minimize driving pressure, plateau pressure minus end expiratory pressure from 3 to 10 cmH2O during one-lung ventilation and a FiO2 of 60%
15961448|NCT03177538|Drug|Corifollitropin alfa and menotropin|"Procedure: Ovarian stimulation is performed by the combination of a single Corifollitropin alfa 150 mcg injection on menstrual cycle day 2-3 and daily menotropin administration at the dose of 150 IU from stimulation day 1-7 and at the dose of 300 IU from day 8 to the end of stimulation (maximal dose adjustment to 450 IU).
~Other interventions: conventional GnRH antagonist protocol and in vitro fertilization (IVF/ICSI) cycle"
15961449|NCT03177538|Drug|Follitropin alfa and lutropin alfa|"Procedure: Ovarian stimulation is performed with daily 300 IU of Follitropin alfa and lutropin alfa starting on menstrual cycle day 2-3. Maximal allowed dose adjustment is 450 IU daily.
~Other interventions: conventional GnRH antagonist protocol and in vitro fertilization (IVF/ICSI) cycle."
15961450|NCT03177525|Behavioral|Social SUCCESS|"Social SUCCESS will run for 12 weeks, with up to 5 children with ASD per group. Parents will attend didactic group sessions focused on motivating children with ASD to initiate to peers (90 min weekly) and will attend a portion of the existing 90 min social group to practice applying these strategies with their children and peer volunteers. Parent training will utilize the manual Improving Socialization in Individuals with Autism."
15961451|NCT03177525|Behavioral|Wait List|Participants assigned to the Wait List will continue stable community treatments for 12 weeks and will be provided an intervention similar to Social SUCCESS upon completion of all post measures.
15961452|NCT03177512|Behavioral|LYNX Mobile App|Access to the LYNX mobile app which includes the Sex Pro score tool, PrEP videos, HIV/STI testing reminders and geo-location features.
15961453|NCT03177499|Procedure|Invasive PPG|Invasive PPG obtained by means of catheterization.
15961454|NCT03177473|Device|CervicalStim bone growth stimulator|Orthofix CervicalStim bone growth stimulator
15961455|NCT03177460|Biological|Daratumumab|Given IV
15961456|NCT03177460|Drug|FMS Inhibitor JNJ-40346527|Given PO
15961457|NCT03177460|Procedure|Radical Prostatectomy|Undergo radical prostatectomy
15961458|NCT03177447|Behavioral|ENABLE CHF-PC|An Advanced Practice Palliative Care Nurse Coach implements Charting Your Course (CYC), a phone-based, 6-session patient curriculum and a 3-session caregiver curriculum, followed by monthly phone supportive care follow-up. Sessions 1-3 incorporate Hegel's problem-solving approach that was modified to counsel seriously ill patients using MacMillan's COPE model reactivity, which includes 4 components: Creativity, Optimism, Planning and Expert information. These sessions address adjusting to chronic illness, symptom management, communication, and decision-making. Patient sessions 4-6 comprise OUTLOOK, a life review intervention to improve QOL in serious illness developed at Duke.
15961459|NCT03177434|Drug|polyethylene glycols (PEG) 3350|Evaluating the efficacy of Dicopeg Junior in comparison with lactulose for the treatment of functional constipation in children aged 6 months to 6 years.
15961460|NCT03177434|Drug|Lactulose Oral Product|Evaluating the efficacy of Dicopeg Junior in comparison with lactulose for the treatment of functional constipation in children aged 6 months to 6 years.
15961461|NCT03177421|Other|Problematic bedtime media use counseling|Participants will be screened for bedtime media use and sleep problems, and the clinical decision support system will recommend counseling on the respective problems identified on screening.
15961462|NCT03177421|Other|Sleep problem counseling|Participants will be screened for sleep problems, and the clinical decision support system will recommend counseling if problems are identified.
15961463|NCT03177395|Drug|PP100-01 (calmangafodipir)|PP100-01
15961464|NCT03177395|Drug|Acetylcysteine|NAC
15961465|NCT03177382|Radiation|Total neoadjuvant treatment|The interventions of experimental group include 1 cycle of CAPOX before radiotherapy; and then start concurrent chemoradiotherapy with CAPOX regimen (capecitabine: 825mg/m2, bid, 5d/w; oxaliplatin, 130mg/m2, D1, q3w) for 2 cycles followed by 3 cycles of CAPOX 2-3 weeks after the completion of radiotherapy. Intensity modulated radiotherapy (IMRT/VMAT) was used for radiotherapy, and the dose was 50-50.4Gy/25-28f, 1.8-2.0Gy/d, 5f/w.
15961466|NCT03177382|Radiation|concurrent chemoradiotherapy|The interventions of control group is standard preoperative concurrent chemoradiotherapy. The radiotherapy target areas and dosage are the same as group TNT. During radiotherapy, only oral capecitabine will be delivered and capecitabine dose was 825mg/m2, bid, 5d/w. The TME surgery will be performed 6-8 weeks after the end of concurrent chemoradiotherapy. Then, patients will receive another 6 cycles of CAPOX.
15961467|NCT03177382|Procedure|TME|The TME operation will be given after the end of the neoadjuvant treatment.
15961468|NCT03177382|Drug|Adjuvant chemotherapy|Patients will receive another 6 cycles of CAPOX after TME.
15961469|NCT03177356|Procedure|extraction,implant placement,PRF|Surgical extraction of mandibular molar using periotome and forceps followed by implant placement in inter-septal bone. Then a blood sample is withdrawn from patient and placed in the centrifuge. Then Platelet-Rich fibrin is placed in the extraction socket as space filling material
15961470|NCT03177356|Procedure|Exctraction,Implant placement,Bone graft|Surgical extraction of mandibular molar using extraction forceps and periotome followed by implant placement in interseptal bone. De-proteinized bovine bone graft material is placed as space filling material
15961471|NCT03177317|Drug|Dexamethasone|"Dexamethasone 8mg IV before chemotherapy on cycle 1 day 1
~Once the complete response is achieved, the dose of dexamethasone will be reduced by 2 mg in the next cycle."
15961472|NCT03177304|Other|Web based IPT Training|
15961473|NCT03177291|Drug|Pirfenidone|"Pirfenidone: 267 mg Capsules by mouth (PO) 3 times per day (TID). Dose Escalation: Level 1:One capsule (total daily dose 801 mg); Level 2: Two capsules (total daily dose 1602 mg); Level 3: Three capsules (total daily dose 2403 mg).
~Dose Expansion: Treatment at dose determined by the Phase 1 Dose Escalation."
15961474|NCT03177291|Drug|Carboplatin|Area under the curve (AUC) 6 on Day 1 of a 21-day cycle for 4 - 6 cycles.
15961475|NCT03177291|Drug|Paclitaxel|200 mg/m^2 on Day 1 of a 21-day cycle for 4 - 6 cycles.
15961476|NCT03177291|Drug|Pemetrexed|500 mg/m^2 on Day 1 of a 21-day cycle for 4 - 6 cycles.
15961477|NCT03177278|Drug|[14C]-plazomicin|single intravenous dose
15961478|NCT03177265|Behavioral|Text messaging prior to first counseling call|This is the first randomization (text to engage vs. mailed notice). Patients randomized to this condition will receive up to 8 text messages prior to the first counseling phone call to provide education regarding cessation treatment.
15961479|NCT03177265|Behavioral|Text-to-Enhance|Two weeks following receipt of the letter (PrO condition) or upon completion of the engagement text messages (Text-to-Engage condition) a counselor trained in motivational interviewing and smoking cessation treatment will phone participants. The Text-to-Enhance condition will receive SMS appointment reminders for telephone counseling appointments and 5 texts per week with tips and suggestions for quitting for a duration of 8 weeks. The telephone counseling condition will receive standard 8 weeks of telephone counseling only.
15961480|NCT03177265|Behavioral|Mail Notice|This is the first randomization (text to engage vs. mailed notice). Patients randomized to this condition will receive a notice in the mail that they will receive a phone call in about 2 weeks to offer telephone cessation treatment.
15961481|NCT03177265|Behavioral|Telephone Counseling|Two weeks following receipt of the mailed notice or upon completion of the engagement text messages (Text-to-Engage condition) a counselor trained in motivational interviewing and smoking cessation treatment will phone participants. The Text-to-Enhance condition will receive SMS appointment reminders for telephone counseling appointments and 5 texts per week with tips and suggestions for quitting for a duration of 8 weeks. The telephone counseling condition will receive standard 8 weeks of telephone counseling only.
15961482|NCT03177252|Drug|Lidocaine|-2% lidocaine will be given
15961483|NCT03177252|Drug|Sodium chloride|-Normal saline will be given
15961484|NCT03177252|Drug|Bupivacaine|-0.5% bupivacaine will be given
15961485|NCT03177239|Drug|Nivolumab|"Dosage Form: Nivolumab BMS-936558-01 Solution for Injection Potency: 100 mg (10 mg/mL) Primary Packaging: 10 mL vial Appearance: Clear to opalescent colourless to pale yellow liquid. May contain particles.
~Storage Condition: 2 to 8°C. Protect from light and freezing."
15961486|NCT03177239|Drug|Ipilimumab|Dosage Form: Ipilimumab Solution for Injection Potency: 200 mg (5 mg/mL) Primary Packaging: 40 mL vial Appearance: Clear, colourless to pale yellow liquid. May contain particles. Storage Condition: 2 to 8°C. Protect from light and freezing.
15961487|NCT03177226|Device|Functional TENS stimulation|A short continuous electrical stimulation, beginning at 0 mAmp and gradually increased by +0.5 mAmp every 2-10 sec to identifying Sensory Threshold (Is) and Motor Threshold (Imc), followed by continuous functional electrical stimulation, throughout the entire self-stimulation phase, equal to his Icm'
15961488|NCT03177226|Device|Non-Functional TENS stimulation|A short continuous electrical stimulation, beginning at 0 mAmp and gradually increased by +0.5 mAmp every 2-10 sec to identifying Sensory Threshold (Is) and Motor Threshold (Imc), followed by continuous non-functional electrical stimulation, throughout the entire self-stimulation phase, equal to his Icm'
15961489|NCT03177187|Drug|AZD5069|10mg and 40mg plain, beige, film-coated tablets packaged in bottles
15961490|NCT03177187|Drug|Enzalutamide 40 MG|Enzalutamide is presented in 40mg white to off white capsules or tablets. The capsules/tablets are provided in a cardboard wallet incorporating a PVC/PCTFE/aluminium blister which holds 28 soft capsules/tablets. Each carton contains 4 wallets (112 soft capsules/tablets). Or tablets in bottles (120 per bottle).
15961491|NCT03177174|Drug|Cisplatin|radiotherapy combined with Chemotherapy Drugs, Cancer
15961492|NCT03177174|Drug|Docetaxel|Docetaxel
15961493|NCT03177161|Other|15 Patient Reported Health Status Questions|The PROMIS-10 Global Health, three single item questions (ambulation, toileting, and dressing) that have been borrowed from the RiksStroke (The National Quality Register for Stroke - Sweden) and two further questions on feeding and communication have been included from the ICHOM Standard Set for Stroke.
15961494|NCT03177148|Behavioral|Intervention by Clinicians|PCPs deliver 4 sessions of MI in person, and RDs deliver 6 sessions of MI via telephone. PCPs and RDs will receive 2 days of MI training.
15961495|NCT03177148|Behavioral|Usual Care|PCPs provide care as normal
15961496|NCT03177135|Device|AmnioSense|A diagnostic pantyliner for detection of amniotic fluid leaks compared with standard clinical diagnosis.
15961543|NCT03176849|Dietary Supplement|Standard Vitamin D3 Supplementation|"Those who have sufficient vitamin D will be supplemented with 400-600IU/day of Vitamin D3 orally.
~Those who have insufficient or are deficient in vitamin D will be supplemented with 50,000IU/week of Vitamin D3 orally."
15961497|NCT03177122|Drug|Myo-inositol|Patients belonging to this group will receive 1 gram of Myo-Inositol, in combination with alpha- lipoic acid and cysteine, (Celine Tablets; Surveal Pharmaceuticals; Belgium) starting 6 weeks prior to stimulation and extending until final oocyte maturation, combined with 400 µg of folic acid supplemented daily.
15961498|NCT03177109|Drug|5% fluoride varnish|Applied topically as a coating at single point in time
15961499|NCT03177109|Drug|8% arginine containing paste|Applied topically as a coating at single point in time
15961500|NCT03177109|Drug|Self-adhesive resin|Applied topically as a coating at single point in time and light cured for 20 seconds
15961501|NCT03177096|Behavioral|Peds QL questionnaire and diabetes modulate|Peds QL questionnaire and diabetes modulate is a pediatric questionnaire about quality of life - children's version and parents version : assessed in the 1st visit (enrollment visit) and after ten months ( V6 End of study)
15961502|NCT03177096|Behavioral|WHO-5 questionnaire|WHO-5 questionnaire is a questionnaire about quality of life : assessed in the 1st visit (enrollment visit) and after ten months (V6 End of Study) by the children
15961503|NCT03177096|Behavioral|Felt questionnaire|Felt questionnaire completed by parents with regard to the welcome of their child in community and by the staffs in preschool, school or in out-of school center : assessed 2 months (V2) and ten months (V6 End of study) after enrollment visit
15961504|NCT03177083|Drug|peginterferon beta-1a|SC every 2 weeks
15961505|NCT03177083|Drug|interferon beta-1a|Per Summary of Product Characteristics (SMPC)
15961506|NCT03177083|Drug|interferon beta-1b|Per SMPC
15961507|NCT03177070|Drug|Methylene Blue|As described above. Intravenous injection with visualisation via fluorescence enabled laparoscope.
15961508|NCT03177057|Behavioral|Compliance Monitoring|Record behavior
15961509|NCT03177057|Other|Health Telemonitoring|Receive health monitoring text messages
15961510|NCT03177057|Other|Questionnaire Administration|Ancillary studies
15961511|NCT03177044|Behavioral|Behavioural treatment|2 to 6 sessions of behavioural training with a pelvic floor physiotherapist
15961512|NCT03177031|Device|Stay Safe Link (SSL)|CAPD system produced in Malaysia by Fresenius Medical Care
15961513|NCT03177031|Device|Stay Safe (STS)|CAPD system produce in Germany by Fresenius Medical Care
15961514|NCT03177018|Diagnostic Test|Cardiomyocytes collection|collect intact cardiomyocytes from which high quality DNA extraction will be achieved
15961515|NCT03177005|Biological|CSL830|
15961516|NCT03176992|Drug|SURGICEL®|insertion of 4 pieces of Surgicel inside the uterine cavity after formal curettage
15961517|NCT03176979|Other|Contrast Agent|Given IV
15961518|NCT03176979|Procedure|Digital Tomosynthesis Mammography|Undergo CESM with DBT
15961519|NCT03176979|Procedure|Dual-Energy Contrast-Enhanced Digital Spectral Mammography|Undergo CESM with DBT
15961520|NCT03176966|Drug|Vitamin E|Patients will take 400 IU vitamin E nightly for 3 months.
15961521|NCT03176966|Drug|Ropinirole|Patients will take 0.5mg ropinirole nightly for 3 months.
15961522|NCT03176966|Other|Muscle cramp survey|Patients will complete a survey of muscle cramp frequency and severity at baseline, 3 months, and 6 months.
15961523|NCT03176953|Drug|topiramate|active medication
15961524|NCT03176953|Behavioral|prolonged exposure|psychotherapy
15961525|NCT03176953|Drug|placebo|non-active medication
15961526|NCT03176940|Dietary Supplement|2-HOBA|2-HOBA is a compound found in buckwheat and is given as 2-HOBA acetate
15961527|NCT03176927|Diagnostic Test|magnetogastrogram|
15961528|NCT03176914|Behavioral|prevention and management of childhood illnesses at community level|provision of critical health education and targeted promotion services to the participants in their locality
15961529|NCT03176914|Behavioral|conventional community interventions|community health programs as the sole source of health education
15961530|NCT03176901|Behavioral|Mindfulness-Based Stress Reduction|This experimental arm presents the actual Mindfulness-Based Stress Reduction program as developed in the late seventies and early eighties in its original eight week format
15961531|NCT03176901|Behavioral|Health Enhancement Program|This active comparison arm presents the official Health Enhancement Program in its eight week format as developed by MacCoon in 2009.
15961532|NCT03176888|Behavioral|Reduced-exertion, high-intensity interval training (REHIT)|As in arm/group description
15961533|NCT03176888|Behavioral|Cognitive behavioral therapy (CBT)|Up to six 30/40-minute sessions of face-to-face psychotherapy will be offered based on a cognitive model of adjustment to cancer utilizing cognitive and behavioral therapy techniques as described by Moorey & Greer (2012)
15961534|NCT03176875|Other|ALICALM (75% of daily caloric requirements)|PEN group will receive 75% of their daily dietary needs from a polymeric formula (Alicalm, Nutricia) and 25% of daily dietary needs (1 meal per day) from an antiinflammatory diet for CD (AID-CD) for 6 weeks.
15961535|NCT03176875|Other|ALICALM (100% of daily caloric requirements)|EEN group will receive 100% of their daily dietary needs from a polymeric formula (Alicalm, Nutricia) for 6 weeks.
15961536|NCT03176862|Diagnostic Test|cardiac magnetic resonance scan|An MRI scan of the heart
15961537|NCT03176862|Diagnostic Test|Cardiopulmonary exercise test with stress echocardiogram|An exercise bicycle test with echocardiogram done during the exercise.
15961538|NCT03176862|Diagnostic Test|24-hour ECG holter monitor|3 stickers attached to a small monitor are worn for 24 hours.
15961539|NCT03176862|Diagnostic Test|12-lead ECG|Can be done immediately by the bedside.
15961540|NCT03176862|Diagnostic Test|Cardiopulmonary exercise test|An exercise bicycle test. No stress echocardiogram.
15961541|NCT03176862|Biological|Blood test|20 mls of blood will be taken to measure routine laboratory tests and biomarkers of fibrosis.
15961542|NCT03176849|Dietary Supplement|Vitamin D3|The single, oral dose of vitamin D3 is based on patient's age and baseline 25-hydroxy-vitamin D level. Dosing is as follows: (1) For children under 3 years of age. 200000IU for those deficient, 150000IU for those insufficient, and 100000IU for those sufficient; (2) For children 3-12 years of age, 400000IU for those deficient, 350000IU for those insufficient, and 200000IU for those sufficient; (3) For children greater than 12 years of age, 600000IU for those deficient, 500000IU for those insufficient, and 300000IU for those sufficient. This is a single, one time oral dose given prior to the start of transplant.
15961650|NCT03176082|Other|Mailed Reminders with Fecal Immunochemical Testing kits|
15961544|NCT03176836|Diagnostic Test|Whole body STIR MRI|Standard technique that detects abnormalities related to excess of water in tissues (edema).
15961545|NCT03176836|Diagnostic Test|DW-MRI|MRI technique that analyzes areas of dead cells within tissues, present in some types of tumor.
15961546|NCT03176836|Diagnostic Test|PET-MRI|MRI technique that detect's the cells' use of glucose, more intensely in harmful cells.
15961547|NCT03176823|Device|CellAegis Technologies autoRIC device|The autoRIC device from CellAegis technologies will be applied as per the manufacturer's instructions on an upper extremity. The device will automatically inflate and deflate a blood pressure cuff to supra-systolic blood pressures, maintaining an occlusive pressure for a period of five minutes, followed by five minutes of re-perfusion with cuff deflation, completing a ten minute cycle. This cycle will repeat four times for a cumulative total of twenty minutes of occlusive conditioning over forty minutes of intervention time.
15961548|NCT03176823|Other|Best Practice Management of Traumatic Brain Injury|Standard treatment of TBI in a dedicated trauma-neuro intensive care unit will include a tiered management strategy corresponding to many published treatment algorithms, including the American College of Surgeons Trauma Quality Improvement Program (ACS TQIP) guidelines for the management of intra-cranial hypertension. Standard practice without limitations will be applied to both cohorts of patients in this study.
15961549|NCT03176810|Device|OCT|OCT is used to guide PCI.
15961550|NCT03176810|Device|Angiography|Angiography is used to guide PCI.
15961551|NCT03176797|Diagnostic Test|Liver MRI|Liver MRI including DWI, IVIM, DKI, T1ρ, T1 mapping of pre-contrast and hepatocyte phase and SWI.
15961552|NCT03176784|Drug|Varenicline|0.5mg and 1.0 mg pills used. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
15961553|NCT03176784|Drug|Nicotine patch|14 mg and 7 mg nicotine patches used. See arms for specific durations.
15961554|NCT03176784|Other|Placebo Patch|Placebo patches matched in appearance to the Active 14 mg and 7 mg nicotine patches used in the Nicotine patch intervention. See arms for specific durations.
15961555|NCT03176784|Other|Placebo Pill|Placebo pills matched in appearance to the Active Varenicline pills in the Varenicline intervention. See arms for specific durations. (Active and placebo varenicline pills provided at no cost through an independent research agreement with Pfizer.)
15961556|NCT03176771|Drug|MT-5199|MT-5199 40 mg capsules
15961557|NCT03176771|Drug|Placebo|MT-5199 placebo capsules
15961558|NCT03176758|Drug|Spinal Block|Intrathecal 10 mg Heavy Marcaine, 200 mcg Morphine + High volume local anesthesia infiltration Bupivacaine 5mg/ml + adrenaline 5 mcg/ml 3mg/kg IBW diluted with 100cc Normal Saline
15961559|NCT03176758|Drug|General anesthetic|1-3 mg IV propofol 0.5 mg/kg IV Rocuronium + Fentanyl 2-3 mcg/kg + Morphine 0.1mg/kg IV Maintenance: Volatile anesthetic + High volume local anesthesia infiltration Bupivacaine 5mg/ml + adrenaline 5 mcg/ml 3mg/kg IBW diluted with 100cc Normal Saline
15961560|NCT03176758|Device|Total knee replacement|A total knee arthroplasty surgery, which is not the intervention of interest
15961561|NCT03176745|Diagnostic Test|multiple breath washout|determination of lung clearance index using SF6 multiple breath washout
15961562|NCT03176732|Device|Positive Airway Pressure|Participants will use Positive Airway Pressure (PAP) treatment
15961563|NCT03176719|Other|Venipuncture|"Full blood count and leukocyte differentiation.
~Detection of malaria parasites and parasite differentiation to trophozoites, gametocytes and ringstages (XN-30)
~Detection of anemia, thallasemia and sickle cell anemia (XN-20)
~Ex-vivo stimulation of wholeblood with various stimuli. Read-out will be a spectrum of cytokines (ELISA)
~Circulating cytokines and inflammatory markers (ELIZA)
~DNA analysis to assess genetic variations determining pro- versus anti inflammatory response including mTOR, HK2, PFKP, GLS, and GLUD1/2.
~pan-Salmonella PCR
~Gametocyte PCR"
15961564|NCT03176706|Other|no intervention|this is a completely observational study, NO INTERVENTION
15961565|NCT03176693|Drug|Phenoxybenzamine|Non-selective alpha blocker
15961566|NCT03176693|Drug|Doxazosin|Selective alpha blocker
15961567|NCT03176680|Procedure|Fluid therapy optimization|colloid 250 mL bolus to increase stroke volume index (SVI). If the increase of SVI is more than 10% of baseline, repeat the bolus. If the increase of SVI is less than 10% of baseline, stop the bolus.
15961568|NCT03176667|Procedure|Ultrasound guided erector spinae plane block|A high-frequency linear ultrasound transducer will be placed in a longitudinal parasagittal orientation 3 cm lateral to the T5 spinous process. The trapezius, rhomboid major, and erector spinae muscles will then be identified superficial to the tip of the T5 transverse process. The patient's skin will be anesthetized with 2% lidocaine. A 17-gauge 8-cm needle will be inserted using an in-plane superior-to-inferior approach to place the tip into the fascial plane on the deep (anterior) aspect of erector spinae muscle. The location of the needle tip will be confirmed by visible fluid spread lifting erector spinae muscle off the bony shadow of the transverse process. A total of 30 mL of 0.5% ropivacaine with 5mcg/mL of epinephrine will be injected in 5-mL aliquots through the needle (maximum of 3mg/kg), followed by insertion of a 19-gauge catheter under direct vision 5 cm beyond the needle tip. The catheter will then be secured in place.
15961569|NCT03176667|Procedure|Intercostal block|The surgeons will identify the desired rib, and advance the needle at an approximately 20-degree angle until contact with rib is made, the needle is then walked of the inferior border of the rib and advanced slightly to plaice the tip of the needle in the neurovascular bundle. The intercostal nerve blocks will be performed at T4-T11 using 0.25% Marcaine with epinephrine and a volume of 5 ml per block (maximum of 2.5mg/kg) after negative aspiration has been confirmed.
15961570|NCT03176654|Procedure|HVLAT manipulation|HVLAT will be performed 10 minutes after the first blood draw.
15961571|NCT03176654|Procedure|Sham HVLAT manipulation|Sham HVLAT will be performed 10 minutes after the first blood draw.
15961572|NCT03176641|Other|platelet-rich plasma|Autologous platelet-rich plasma gel applied during meniscus repair surgery
15961573|NCT03176641|Other|control|Meniscus repair surgery only
15961574|NCT03176628|Dietary Supplement|Basis|NR is a form of vitamin B3; Pterostilbene is a natural dietary compound and the primary antioxidant component of blueberries
15961575|NCT03176628|Dietary Supplement|Placebo|Placebo capsule(s)
15961576|NCT03176615|Dietary Supplement|Experimental diet|The intervention will run concurrently with the gastric bypass treatment at the hospital. The first intervention is carried out before weight loss, and the intervention is repeated two times concurrently with two periods of weight loss (lifestyle and gastric bypass)
15961577|NCT03176589|Device|positive expiratory pressure (PEP)|Patients take a deep inspiration followed by PEP expiration with an expiratory pressure of 10-15 cm H2O
15961578|NCT03176589|Device|Placebo comparator, Deep inspiration and expression in a placebo tube without resistance|Deep inspirations 3 times 10 and expiration in a placebo tube without expiratory resistance
15961579|NCT03176589|Other|Deep breathing maneuvers|deep breathing maneuvers 3 times 10 breahs without any device at expiration
15961580|NCT03176576|Behavioral|Patient Navigator (PN)|Patient navigation (PN) is an intervention model designed to assist vulnerable patients in overcoming health system, personal and/or logistical barriers to care throughout the cancer care continuum. The strategic aims of PN are to reduce barriers and improve disease outcomes while also reducing distress and enhancing quality of life for the patient and family. Participants in the PN group will meet with a patient navigator.
15961581|NCT03176576|Other|Baseline Questionnaire|Complete a baseline questionnaire online or by meeting with a member of the study team. This questionnaire has items asking about the participant's health, distress levels, satisfaction with their care at Moffitt Cancer Center, and what support services they have used since their diagnosis. This questionnaire will take about 15 to 20 minutes of their time.
15961582|NCT03176576|Other|Follow-up Questionnaire|After participants complete the baseline questionnaire, they will be asked to complete a follow-up questionnaire approximately 6 weeks from when they completed the baseline questionnaire. The follow-up questionnaire will take about 15 to 20 minutes to complete.
15961583|NCT03176576|Other|Patient Navigator Satisfaction Survey|Evaluation of Patient Navigator intervention process.
15961584|NCT03176563|Drug|Arctuvan|application of a herbal drug in the clinical trial REGATTA (NCT03151603)
15961585|NCT03176563|Drug|Placebo to Fosfomycin|application of Placebo to Fosfomycin in the clinical trial REGATTA (NCT03151603)
15961586|NCT03176563|Drug|Fosfomycin|application of an antibiotic drug in the clinical trial REGATTA (NCT03151603)
15961587|NCT03176563|Drug|Placebo to Arctuvan|application of Placebo to Arctuvan in the clinical trial REGATTA (NCT03151603)
15961588|NCT03176550|Device|Transcutaneous electrical nerve stimulation|TENS is performed using a commercially available device (ProStim, Alimed Inc, Dedham, Massachusetts, USA). One pair of 2 x 3.5 inches rectangular electrodes (Vermed ChroniCare TENS Electrodes, Vermed, Buffalo, NY, USA) are placed to simultaneously stimulate both median and ulnar nerves at the wrist, while a second pair of round 2 inch diameter electrodes are used to stimulate the radial nerve on the forearm. Bursts of electrical stimulation at 10 Hz (100 microsecond pulse width duration) are delivered to all nerves simultaneously for 2 hours.
15961589|NCT03176537|Drug|Testosterone gel|Androgel (50mg testosterone), gel, daily
15961590|NCT03176537|Drug|Placebos|Placebo, gel, daily
15961591|NCT03176524|Drug|BioChaperone® glucagon formulation 1|Injection of BioChaperone® glucagon formulation 1 at Day 1: 50 µg and at Day 2: 1 mg
15961592|NCT03176524|Drug|BioChaperone® glucagon formulation 2|Injection of BioChaperone® glucagon formulation 2 at Day 1: 50 µg and at Day 2: 1 mg
15961593|NCT03176524|Drug|GlucaGen® HypoKit®|Injection of GlucaGen® HypoKit® at Day 1: 50 µg and at Day 2: 1 mg
15961594|NCT03176511|Behavioral|A Matter of Balance plus Dual-Task Balance Challenge Group|Participants will receive the standard MOB classes, along with a 15-min DTBC each class, i.e., right and left foot ankle-reaching to three differently colored markers. Three colored dots are placed on the ground in an arc, using different colored stick-on dots. A chair can be placed in front of the color pattern, as needed for safety.
15961595|NCT03176511|Behavioral|A Matter of Balance Group|Participants will receive the standard MOB class, taught by a certified MOB, using course materials developed by MaineHealth's Partnering for Healthy Aging (http://www.mainehealth.org/pfha).
15961596|NCT03176498|Biological|Allogeneic umbilical cord mesenchymal stem cell|Experimental group receive Allogeneic umbilical cord mesenchymal stem cell，i.v (SCLnow 19#)
15961597|NCT03176498|Drug|Aspirin Enteric-coated Tablets & Atorvastatin Calcium|Aspirin Enteric-coated Tablets, 0.1g/d by mouth; Atorvastatin Calcium, 20mg/d by mouth.
15961598|NCT03176485|Other|Solar Simulator|A Multiport UV Solar Simulator Model 600 (Solar Light Co., Inc., Philadelphia, PA) will be used to administer Solar Simulated Light (SSL) exposures to formerly unexposed buttock skin.The device is equipped with six 8mm liquid light guides (LLG), allowing for 6 simultaneously conducted exposures.A large 3x2 endplate places the LLGs several centimeters apart and is specifically designed for Sun Protection Factor (SPF) and photo patch testing. The dose of emission from each LLG can be precisely regulated and the spectrum of emission can be limited to UVA (320-390 nm) or UVB+UVA (290-390 nm). The operator can select between UVA only and a combined Ultraviolet-A (UVA)/ Ultraviolet-B (UVB) spectrum by placement of an optical filter. The spectral output (indicated below) follows the distribution of sunlight from 290 to 390 nm.
15961599|NCT03176472|Drug|ricolinostat|120 mg per dose in 12 mL liquid formulation
15961600|NCT03176472|Drug|Placebo|12 mL liquid formulation placebo
15961601|NCT03176459|Drug|Exparel + Bupivacaine|EXPAREL is a local analgesic that utilizes bupivacaine in combination with the proven product delivery platform, DepoFoam®.
15961602|NCT03176459|Drug|Bupivacaine|Bupivacaine Hydrochloride is indicated for the production of local or regional anesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures.
15961603|NCT03176446|Device|Local anesthesia with traditional technique|Puncture with short needle in the region of the apical third of the tooth to be anesthetized Injection of local anesthetic, with speed 1ml / min
15961604|NCT03176446|Device|Local anesthesia with computerized technique|Puncture with short needle in the region of the apical third of the tooth to be anesthetized according to the recommendations of the manufacturer Injection of local anesthetic with computerized anesthesia equipment, with speed 0.5 ml / min
15961605|NCT03176446|Device|Local anesthesia with DentalVibe technique|Use of DentalVibe in the apical region of the tooth to be anesthetized according to the manufacturer's guidelines Puncture with short needle enters the tips of the DentalVibe Injection of local anesthetic with traditional carpule, with speed 1 ml / min
15961606|NCT03176446|Drug|Topic anesthesia|Application of topical anesthetic for 60 seconds with benzocaine
15961607|NCT03176446|Drug|Local anesthetic|2% lidocaine with epinephrine 1: 100000 1.8 mL
15961608|NCT03176433|Device|Normothermic Machine Liver Perfusion|Liver Preservation Method
15961651|NCT03176082|Other|Reminder letter only|
15961609|NCT03176420|Procedure|angioplasty and stenting of occluded cervical ICA|The procedure is performed under monitored anesthetic care. We will perform a thorough and complete six-vessel diagnostic angiogram to completely characterize the occlusion and presence of collaterals. A distal protection device is used unless technically can't be delivered beyond the occlusion or when the occlusion extends beyond the petrous segment of the internal carotid artery. Balloon angioplasty is performed followed by deployment of covered stents to jail the clot/organized thrombus. The carotid reconstruction is performed from the distal to the proximal segment with coronary stents that are telescoped until normal flow is encounter. The Blood pressure is managed rigorously during and after the procedure to minimize the chances of reperfusion hemorrhage.
15961610|NCT03176407|Diagnostic Test|HemoPill acute|Capsule is swallowed by the patient and an external study receiver records the capsule sensor data for 4 consecutive hours. Patients undergo endoscopy within 12 hours after capsule ingestion. Afterwards, the endoscopic findings (endoscopy pictures and patient's endoscopy report) are compared to the sensor capsule data results. Capsule excretion is monitored for up to 4 days. If excretion is not recorded during that time, a follow-up examination of the patient is conducted after 10 days.
15961611|NCT03176394|Device|BLASTX Gel|Foley Catheter lubricated with BLASTX Gel
15961612|NCT03176394|Device|McKesson Jelly|Foley Catheter lubricated with McKesson Jelly
15961613|NCT03176368|Other|Coconut Oil|Coconut Oil
15961614|NCT03176355|Procedure|Canaliculo- Dacryocystorhinostomy|Bypass lacrimal passage obstruction by opening a shunt between the lacrimal sac and the nasal mucosa
15961615|NCT03176342|Other|patch test|Patch test allergen from chemotechnique diagnostics, pure drug and drug as is combine with petrolatum or aqueous.
15961616|NCT03176329|Other|Nursing 1 : INTELLIVENT-ASV|
15961617|NCT03176329|Other|Nursing 2 : INTELLIVENT-ASV|
15961618|NCT03176329|Other|Nursing 1 : Conventional mode|
15961619|NCT03176329|Other|Nursing 2 : Conventional mode|
15961620|NCT03176316|Drug|Naloxone|"Blinding/labeling/preparation of agents: No blinding is required in this study. The study drug will be prepared, unit dose labelled, and patient labelled according to institutional protocols.
~Storage: Secured at room temperature in the central pharmacy then dispensed as a patient specific supply and stored at room temperature the automated dispensing cabinet. No more than a 24 hour supply will be dispensed at any given time.
~Administration: 1 mg/ml oral solution administered enterally (oral, nasogastric, orogastric, gastrostomy, or jejunostomy ) every 8 hours for 48 hours"
15961621|NCT03176303|Device|SpinalStim|PEMF osteogenesis stimulator
15961622|NCT03176290|Diagnostic Test|Fibro-α score = (1.35 (numeric constant) +AFP (IU ml-1) × 0.009584 + aspartate aminotransferase (AST)/alanine aminotransferase(ALT) × 0.243 - platelet count (×109 l-1) × 0.001624).|Radiological investigations included Abdominal Doppler ultrasound, Magnetic Resonance Elastography(within 3 months of liver biopsy) and fibroscan.
15961623|NCT03176277|Drug|ONO-7475|ONO-7475 tablets
15961624|NCT03176277|Drug|ONO-7475 + venetoclax|ONO-7475 tablets + venetoclax tablets
15961625|NCT03176264|Drug|PDR001|400 mg every 4 weeks
15961626|NCT03176264|Drug|bevacizumab|5 mg/kg every 2 weeks
15961627|NCT03176264|Drug|mFOLFOX6|Combination of chemotherapy administered every 2 weeks: oxaliplatin (85mg/m2), 5-Fluorouracil (2400mg/m2) and folinic acid (=leucovorin, 400mg/m2)
15961628|NCT03176251|Other|Gamified-Integrated Curriculum|The experimental group will receive identical training compared to the control group, with the additional incorporation of several elements of gamification, as outlined in the Arm/Group descriptions.
15961629|NCT03176238|Drug|everolimus|one 10 mg tablet or two 5 mg tablets of everolimus were administered orally once daily on a continuous dosing schedule starting on Day 1
15961630|NCT03176238|Drug|exemestane|25 mg tablet was administered orally once daily on a continuous dosing schedule starting on Day 1
15961631|NCT03176225|Procedure|Open heart surgery to address the heart disease|The patient will first have open heart surgery to achieve access to the diseased site in the heart
15961632|NCT03176225|Device|Close the defects with XenoSure Patch|The heart defects, such as ASD (Atrial Septal Defect) or VSD (Ventricular Septal Defect ), are closed with LeMaitre XenoSure Patch.
15961633|NCT03176225|Device|Close the defects with Chest Polyester Patch|The heart defects, such as ASD (Atrial Septal Defect) or VSD (Ventricular Septal Defect ), are closed with a Polyester Patch made by Shanghai Chest Medical Technology Co.
15961634|NCT03176212|Dietary Supplement|Milk fat globule membrane|
15961635|NCT03176199|Drug|Oxycodone|Every 12 hours for control-released oxycodone (OxyContin®)
15961636|NCT03176199|Drug|Oxycodone|Every 6 hours for immediate-released oxycodone (OxyNorm®)
15961637|NCT03176186|Combination Product|Xenon|50% xenon by inhalation, delivered by customized xenon delivery system, that includes a ventilator, for the 24h period of TH/TTM. The inhalation therapy is provided in combination with protocol-directed Post-Cardiac Arrest Care dictated by the 2015 guidelines from the American Heart Association and the European Resuscitation Council.
15961638|NCT03176173|Biological|Immunotherapy (standard of care)|Receive standard of care immunotherapy (nivolumab, pembrolizumab, atezolizumab)
15961639|NCT03176173|Radiation|Image Guided Radiation Therapy|Undergo image guided radiation therapy
15961640|NCT03176173|Other|Laboratory Biomarker Analysis|Correlative studies
15961641|NCT03176160|Other|Palliative regimen consisting of LITT|Minimally invasive technique to necrotize intracranial lesions
15961642|NCT03176147|Other|Iron deficiency anemia|The prevalence of iron deficiency anemia is determined at T3 (after 34 SA). The predictive factors for this anemia will be sought according to the data collected in T1.
15961643|NCT03176134|Drug|Tedizolid phosphate|Tedizolid phosphate IV solution or oral suspension
15961644|NCT03176134|Drug|Comparator|Vancomycin IV, linezolid IV or oral (outside European Union only), clindamycin IV or oral, flucloxacillin IV or oral, cefazolin IV, or cephalexin oral provided locally by the trial site and administered per local standard of care
15961645|NCT03176121|Drug|Oxycodone|Patients will take either CR oxycodone or IR oxycodone or both for initial dose and used it to titrate his/her background dose.
15961646|NCT03176108|Behavioral|Cognitive Behavorial Therapy (CBT)|Cognitive Behaviorial Therapy (CBT)
15961647|NCT03176108|Behavioral|Body mediation|Body mediation (theatre)
15961648|NCT03176095|Dietary Supplement|Probiotic|
15961649|NCT03176095|Dietary Supplement|Placebo|
15961652|NCT03176069|Other|Evaluation and Comparison of women pelvic floor with and without sexual dysfunction|Pelvic floor muscles will also be evaluated by electromyographic biofeedback.
15961653|NCT03176069|Other|The physiotherapeutic treatment|"The available treatment tools are educational, behavioral and rehabilitating. The physiotherapeutic treatment will consist of the following features:
~Kinesiotherapy
~Manual therapy
~Electrotherapy (electric electrostimulation, ultrasound)
~Behavioral therapy"
15961654|NCT03176056|Dietary Supplement|Low carbohydrate diet|For the LCD group, the daily carbohydrate intake was limited to less than 90g, without any restriction to total energy. The concept of a LCD was introduced and an educational 15 g equivalent carbohydrate food list was provided. The easy conversion method is that 15 g equivalent carbohydrate =1/4 bowel of rice= 1/2 bowel of noodle = 1 slice of toast = 3 soup-spoon of oats = one bowl of fruit =1/2 regular size banana= one glass of milk = 3 dumplings. Less than two equivalent 15g-carbohydrate intakes per meal were advised.
15961655|NCT03176056|Dietary Supplement|Calori restricted diet|For the calori restricted diet group, the target total calorie intake was calculated by multiplying the ideal body weight by 25 kcal/kg for those with a BMI in the range 18.5 to 24, 20 kcal/kg for obese subjects with a BMI > 24 and 30 kcal/day for underweight subjects with a BMI <18.5. The macronutrient percentage was 50-60% for carbohydrate, 1.0-1.2 g/kg for protein and fat ≦30%.
15961656|NCT03176043|Procedure|IV Fluid Administration|Administration of 4% Dextrose in 0.18% Sodium Chloride, through an IV cannula via a volumetric infusion pump.
15961657|NCT03176030|Dietary Supplement|Fortified Foods|The intervention under study is the provision of between-meal fortified foods (enhanced with protein, energy, and micronutrients) and meal supplementation where meals are poorly consumed. Foods will include both savory and sweet foods with different flavors. Foods will be matched as closely as possible in protein and energy and are calculated to provide typically 210 kcal and 5g protein per item. The volume / weight of the foods are standardized to be of relatively small portion size, such as 100 ml for ice-creams, 40 g for cakes and biscuits, and 100 ml for soup. Some of the products will be supplemented with micronutrients particularly needed by older adults, such as Vitamins (C, D, folic acid, B2, B6) and calcium at one third of the Dietary Reference Values (DRV) per portion. The aim is to achieve a daily consumption of two additional fortified food items.
15961658|NCT03176017|Procedure|Ejaculatory sparing TUIP|The bladder neck will be incised and vaporized at the 5 or 7-o'clock position. The incision will start near the ureteral orifice and carry downward to about 0.5-1.0 cm proximal to the verumontanum
15961659|NCT03176017|Procedure|Conventional TUIP|the bladder neck will be incised by Collins knife at the 5 or 7-o'clock position till the verumontanum.
15961660|NCT03176004|Other|Attention Bias Modification|A computer game is used to facilitate attention away from threatening words.
15961661|NCT03175991|Diagnostic Test|ultrasonography|"A morphologic evaluation will be performed according to International Ovarian Tumor Analysis Group recommendations for the following parameters:
~Bilaterality , wall thickness, septations , papillary projections, solid areas, and echogenicity. The presence of ascites also will be recorded. Pattern recognition analysis will be used for ovarian masses highly suggestive of some diseases , then color Doppler will be activated to identify vascular color signals within the lesion."
15961662|NCT03175978|Drug|IGF/MTX|765IGF-MTX is supplied as a 5 ml sterile solution at 4.0 µeq per ml 765IGF-MTX concentration in aqueous 10 mM HCl in a 10 ml glass vial
15961663|NCT03175965|Device|Somatosensory evoked potential|Somatosensory evoked potential on 24, 72 hours after cardiac arrest.
15961664|NCT03175952|Diagnostic Test|virtual histology intravascular ultrasound|Patients with saphenous vein graft disease will be examined using virtual histology intravascular ultrasound, and treated with percutaneous coronary intervention. Then they will be followed up at 1, 6 and 12 months.
15961665|NCT03175939|Radiation|Radiotherapy|External beam radiotherapy with curative intent, at least 66 Gy
15961666|NCT03175939|Drug|Cisplatin|cisplatin IV injection over 3 hours
15961667|NCT03175939|Drug|5-FU|5-FU IV 24 hours continuous infusion
15961668|NCT03175926|Device|placebo Diskus®|device will be given daily for one week, two puffs per day
15961669|NCT03175926|Device|placebo Ellipta®|device will be given daily for one week, one puff per day
15961670|NCT03175926|Device|Pulmicort® Turbuhaler®|device will be given daily for one week, two puffs per day
15961671|NCT03175913|Device|vapocoolant spray|As a topical pre caudal epidural block anesthesia, spinal needle insertion site was sprayed using an vapocoolant spray for 10-sec from a distance of 30 cm
15961672|NCT03175913|Drug|local infiltration|As a topical pre caudal epidural block anesthesia, spinal needle insertion site was injected subcutaneously using 3ml of 2% lidocaine
15961673|NCT03175900|Drug|Naoan dripping pills|"Patients will take 20 pills(1000mg) after meal twice a day for 12 weeks, Fenbid can be taken if headache is unbearable, but make sure the records(including attack time, drug dosage, pain intensity and duration) are written down as detailed as possible.
~Procedure: MRI scanning (fMRI and DTI）"
15961674|NCT03175900|Drug|Placebo|"Patients will take 20 pills(1000mg) after meal twice a day for 12 weeks, Fenbid can be taken if headache is unbearable, but make sure the records(including attack time, drug dosage, pain intensity and duration) are written down as detailed as possible.
~Procedure: MRI scanning (fMRI and DTI)"
15961675|NCT03175887|Device|TMS|Transcranial magnetic stimulation (TMS) is a noninvasive procedure that uses magnetic fields to stimulate nerve cells in the brain to improve symptoms of depression.
15961676|NCT03175874|Procedure|Hip bone sampling|Quantification of autophagy (LC3II and SQSTM1 / p62) by Western blotting of purified OST proteins from a bone sample
15961677|NCT03175861|Other|Stereotactic radiotherapy|"The patient will have an initial pre-therapeutic assessment in the 8 weeks before the start of radiotherapy Then, radiation therapy planning with 3 free breathing 4D (4 dimensions) scanners performed over 8 days without injection of iodinated contrast agent.
~Then the patient will receive his treatment by conventional stereotactic radiotherapy"
15961678|NCT03175848|Radiation|Chemotherapy,radiotherapy|Pelvic,pelvic-inguinal,or extended field radiotherapy：Therapy 45 - 50 Gy in 1.7 - 2.0 Gy daily fractions over 4.5 - 5.5 weeks for PTV Brachytherapy: Therapy 5-6 fractions of 4-6Gy prescribed to the high-risk CTV or A piont.
15961679|NCT03175835|Drug|Rosuvastatin 20 mg|Treatment A: Rosuvastatin 20 mg(20 mg X 1 tablet) for Day1~Day5
15961680|NCT03175835|Drug|CKD-519 200 mg|Treatment B: CKD-519 200 mg(100 mg X 2 tablets) for Day9~Day21
15961761|NCT03175289|Other|Expiratory Muscle Strength Training|Participate in EMST
15961681|NCT03175835|Drug|Rosuvastatin 20 mg & CKD-519 200 mg|Treatment C: Rosuvastatin 20 mg(20 mg X 1 tablet), CKD-519 200 mg(100 mg X 2 tablets) for Day22~Day26
15961682|NCT03175822|Behavioral|Visual Arts Training|The art training program has been designed as a drawing program and focuses on basic visual art concepts (the elements [e.g., colour and line] and principles [e.g., proportion and balance] of design). Each week has a different activity and a different focus (one activity per week focusing on one element and principle of design). Each art training program will occur one hour per day, two days per week, for eight weeks. The art training program will take place at the participants' respective dementia care location in an area separate from waitlist control participants and uninvolved clients. All art programs are free for participants.
15961683|NCT03175809|Other|PFM training|The PFM training will be delivered with an electromyographic biofeedback (bEMG). In order to perform the muscular training, the Biotrainer software was used, the training protocol will follow a rationale of evolutionary complexity throughout each session. The training protocols will focus on both muscle relaxation and contraction training and coordination.The parameters for the biofeedback will be tailored to the participant's presentation and will be determined and adjusted between each session as needed by the treating therapist. The treatment parameters will be determined by the treating therapist based on the participant's assessment that will be conducted at each treatment session. The Maximum voluntary contraction will be assessed at the beginning of each training day.
15961684|NCT03175809|Other|Dry needling|The dry needling technique will be applied to the abdominal muscles (external oblique, rectus abdominis), lumbar spine (lumbar multifidus and erector spinae) and hip muscles (piriformis, gluteus medius, psoas major and adductors). Both active of latent myofascial trigger points will be treated with sterile stainless steel needles (0.25x0.4 mm or 0.2x0,7mm, DongBang, Korea). After diagnosis of the area of muscle pain, the tight band of the muscle will be palpated and the needle will be introduced subcutaneously. The second insertion will be toward the muscle point until a local twitch response (LTR) is elicited. Then the needle will be removed and the area will be compressed for 30 seconds.
15961685|NCT03175796|Behavioral|Infant Mental Health-Home Visiting|Behavioral intervention aimed to increase parental competencies and promote mental health and sensitive caregiving.
15961686|NCT03175783|Device|Fitbit Zip Activity Tracker|Subjects from both treatment and control group will be put on wristband starting from one week before the scheduled operation until 7 post-operative days. Patients will be instructed to wear the wristband continuously 24 hours per day except during water based activity. The treatment group will receive normal wristband with indicator showing steps count, distance, and calories. Meanwhile, the control group will receive Fitbit Zip with a display covered with adhesive tape and will not receive automatic feedback on the mobility from the device.
15961687|NCT03175770|Procedure|transoral radiofrequency Resection in Oropharyngeal Tumor Surgery|Patient of 18 years and older with benign or malign tumor in the oropharynx. The resection is done transorally by radiofrequency
15961688|NCT03175757|Dietary Supplement|Turmeric and Black Cumin Seed|Turmeric and Black Cumin Seed formulation
15961689|NCT03175757|Dietary Supplement|Placebo|Placebo
15961690|NCT03175744|Device|Stellarex DCB|Intervention with the Stellarex DCB
15961691|NCT03175744|Device|PTA Catheter|Intervention with an uncoated Standard PTA
15961692|NCT03175731|Drug|Proton Pump Inhibitors|Pantoprazole 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.
15961693|NCT03175731|Drug|Placebo|Placebo 40mg per day intravenously or orally for 2 weeks after endoscopic treatment.
15961694|NCT03175718|Other|VAC Wound Dressing|A total of 291 patients will be randomized to receive 2 weeks of Incisional Negative pressure wound dressing (Acetily®). The sterile dressing will be applied under a continuous pressure of 125mmHg. The dressing will be changed every 2-3 days. For a total duration of 2 weeks.
15961695|NCT03175718|Other|Wound Dressing|A total of 291 patients will be randomized for standard gauze dressing. This dressing requires no pressure and is applied according to the current standard dressing procedures of the institution. The dressing will be changed every 2-3 days. For a total duration of 2 weeks.
15961696|NCT03175705|Biological|HCC antigens-specific CD8+ T lymphocytes|"Three different dosing schedules will be evaluated. Three patients will be evaluated on each dosing schedule.
~The following dose levels will be evaluated:
~Loading Dose 1: 3x10^7/m2 Loading Dose 2: 6x10^7/m2 Loading Dose 3: 9x10^7/m2 The doses are calculated according to the actual number of GPC3/NY-ESO-1/AFP specific cytotoxic lymphocytes (CTLs)"
15961697|NCT03175705|Drug|IL-2|IL-2 will be given at a dose of 25000 IU/kg/day for 5-14 days.
15961698|NCT03175705|Drug|Tegafur|Tegafur will be given at a dose of 40~60 mg bis in die (BID) 2 weeks.
15961699|NCT03175692|Diagnostic Test|Whole Exome Sequencing|Using next generation sequencing to analysis patient's whole exome. To explore the pathogenic gene variation.
15961700|NCT03175679|Biological|iNKT cells|"Three different dosing schedules will be evaluated. Three patients will be evaluated on each dosing schedule.
~The following dose levels will be evaluated:
~Loading Dose 1: 3x10^7/m2 Loading Dose 2: 6x10^7/m2 Loading Dose 3: 9x10^7/m2 The doses are calculated according to the actual number of iNKT cells."
15961701|NCT03175679|Drug|IL-2|IL-2 will be given at a dose of 25,000 IU/kg/day for 5-14 days.
15961702|NCT03175679|Drug|Tegafur|Tegafur will be given at a dose of 40~60 mg bis in die (BID) 2 weeks.
15961703|NCT03175666|Biological|avelumab|Fully human anti-PD-L1 IgG1 lambda monoclonal antibody
15961704|NCT03175666|Biological|bevacizumab|Recombinant human anti-VEGF IgG1 monoclonal antibody
15961705|NCT03175666|Drug|capecitabine|5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine
15961706|NCT03175666|Drug|cisplatin|(SP-4-2)-diamminedichloroplatinum(II)
15961707|NCT03175666|Drug|cyclophosphamide|2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
15961708|NCT03175666|Drug|5-Fluorouracil|5-fluoro-2,4 (1H,3H)-pyrimidinedione
15961709|NCT03175666|Drug|Leucovorin|Calcium N-[p-[[[(6RS)-2-amino-5-formyl-5,6,7,8-tetrahydro-4-hydroxy-6-pteridinyl]methyl]amino]benzoyl]-L-glutamate (1:1)
15961710|NCT03175666|Drug|nab-paclitaxel|5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine
15961711|NCT03175666|Drug|Lovaza|omega-3-acid ethyl esters)
15961712|NCT03175666|Radiation|Stereotactic Body Radiation Therapy|(SBRT)
15961713|NCT03175666|Biological|ALT-803|recombinant human super agonist interleukin-15 (IL-15) complex
15961714|NCT03175666|Biological|ETBX-011|adenovirus serotype-5 [Ad5] [E1-, E2b-]-CEA (carcinoembryonic antigen)
15961715|NCT03175666|Biological|ETBX-051|Ad5 [E1-, E2b-]-Brachyury
15961716|NCT03175666|Biological|ETBX-061|Ad5 [E1-, E2b-]-mucin 1 (MUC1)
15961717|NCT03175666|Biological|GI-4000|RAS yeast vaccine
15961718|NCT03175666|Biological|GI-6207|CEA yeast vaccine
15961719|NCT03175666|Biological|GI-6301|Brachyury yeast vaccine
15961720|NCT03175666|Biological|haNK|NK-92 [CD16.158V, ER IL-2], Suspension for Intravenous [IV] Infusion (haNK™ for Infusion)
15961721|NCT03175653|Other|Oxycodone Pill A|Prescription for oxycodone pills for post-Cesarean delivery pain control after hospital discharge. Oxycodone is an opioid.
15961722|NCT03175653|Other|Oxycodone Pill B|Prescription for oxycodone pills for post-Cesarean delivery pain control after hospital discharge. Oxycodone is an opioid.
15961723|NCT03175640|Behavioral|Implementation intervention|The implementation intervention includes peer-to-peer training, post-training outreach, proactive expert support, and assistance with addressing environmental barriers.
15961724|NCT03175627|Device|Filtek One|Restoring a posterior permanent tooth in need of a filling applying Filtek One using bulk fill technique.
15961725|NCT03175627|Device|Filtek Z250|Restoring a posterior permanent tooth in need of a filling applying Filtek Z250 using incremental filling technique.
15961726|NCT03175614|Other|Intervention group|Smartphone with APP (EVIDENT III) and a Smartband for 3 months. Counseling on physical activity and nutrition
15961727|NCT03175614|Other|Control: Lifestyle counseling|Conseling on physical activity and nutrition (intervention)
15961728|NCT03175588|Other|Virtual Rehabilitation|Nintendo Wii program with balance board, which is the most frequently preferred game consoles in rehabilitation will be used
15961729|NCT03175575|Behavioral|Access to a community garden in deprived neighborhoods|
15961730|NCT03175562|Other|Facial micellar cleanser|Participant will have each product applied topically via semi occlusive patch, on site by the technician. Each patch will remain in place for 48 (± 2) hours on weekdays and 72 (± 2) hours on weekends.
15961731|NCT03175562|Other|Saline Solution: Sodium Chloride (NaCl; 0.9%)|Participant will have each product applied topically via semi occlusive patch, on site by the technician. Each patch will remain in place for 48 (± 2) hours on weekdays and 72 (± 2) hours on weekends.
15961732|NCT03175549|Drug|Apremilast|50 mg/bid, oral pill, 5 days following 9 day titration
15961733|NCT03175549|Drug|Placebo|Oral pill, 14 days
15961734|NCT03175536|Other|HDHP with PDL|Enrollment in a Health Savings Account-eligible high-deductible health plan with an annual individual deductible of >$1000 that includes a preventive drug list (a list of certain chronic medications that are exempt from the deductible)
15961735|NCT03175523|Device|quantitative coronary angiography guided Bioresorbable scaffold implantation|In the QCA-guided group, BRS size and length were chosen by both visual estimation and on-line QCA, and adjunct high-pressure dilation is routinely performed to achieve angiographic residual diameter stenosis less than 30% by QCA and absence of angiographically visible dissections.
15961736|NCT03175523|Device|imaging guided Bioresorbable scaffold implantation|In the imaging-guided group, imaging is used at any step of percutaneous coronary intervention(PCI) before, during, or after PCI. Final image examination after PCI is mandatory.
15961737|NCT03175497|Drug|Telatinib Mesylate|Telatinib mesylate tablets will be administrated twice a day orally
15961738|NCT03175458|Procedure|sinus lift,implant placement,tenting|elevation of the sinus membrane then insertion of the implants without any bone graft material( graft-less) for augmentation
15961739|NCT03175458|Procedure|sinus lift,implant placement,bovine bone|sinus membrane elevation then placement of the implants together with deproteinized bovine bone substitute as a graft material for augmentation
15961740|NCT03175445|Other|CBCT scan by planmeca promax|software measurement tool of CBCT
15961741|NCT03175432|Drug|Atezolizumab|Given IV
15961742|NCT03175432|Biological|Bevacizumab|Given IV
15961743|NCT03175432|Drug|Cobimetinib|Given PO
15961744|NCT03175432|Procedure|Quality-of-Life Assessment|Ancillary studies
15961745|NCT03175406|Diagnostic Test|Manipal cervical scoring system|
15961746|NCT03175393|Device|coronary angiography|per cutaneous coronary intervention to identify severity of coronary artery disease by syntx score
15961747|NCT03175380|Biological|bacillus Calmette-Guérin|BCG injection for prevention of tuberculosis
15961748|NCT03175367|Drug|Evinacumab|SC or IV administration
15961749|NCT03175367|Drug|Matching placebo|SC or IV administration
15961750|NCT03175367|Other|Background Lipid Modifying Therapy (LMT)|All participants should be on a stable, maximally tolerated statin throughout the duration of the study. The dose of statin and of PCSK9 inhibitor, such as alirocumab or evolocumab, as well as other LMT (if applicable), should remain stable throughout the study duration, from screening through the end of study (EOS) visit.
15961751|NCT03175354|Drug|ALX-101 Gel 1.5% and ALX-101 Gel Vehicle|Bilateral application of ALX-101 Gel 1.5% and ALX-101 Gel Vehicle
15961752|NCT03175354|Drug|ALX-101 Gel 5% and ALX-101 Gel Vehicle|Bilateral application of ALX-101 Gel 5% and ALX-101 Gel Vehicle
15961753|NCT03175341|Drug|Ascorbic Acid|1,5 g ascorbic acid dissolved in 100 ml sterile water, and 0,75 g ascorbic acid dissolved in 100 ml sterile water.
15961754|NCT03175341|Drug|Placebos|100 ml normal saline 0.9%
15961755|NCT03175328|Procedure|continuous renal replacement therapies|The choice of the method of continuous renal replacement therapy (device setting and anticoagulation method) is left to the discretion of each study site and was prescribed and monitored according to national guidelines.
15961756|NCT03175315|Behavioral|Treatment and education program for patients with diabetes who use flash glucose monitoring (FLASH)|Treatment and education program based on the self-management theory of behavioral medicine. The program is delivered by certified and specially trained diabetes educators.
15961757|NCT03175302|Behavioral|digital cognitive testing|The digital testing is hypothesized to identify latent features for differentiating cognitively impaired presurgical patient subgroups
15961758|NCT03175289|Other|Best Practice|Undergo therapy session conducted by a speech pathologist
15961759|NCT03175289|Other|Educational Intervention|Receive standard of care patient education materials focusing on oral care, signs/symptoms of dysphagia/aspiration, and trismus
15961760|NCT03175289|Other|Exercise Intervention|Perform prescribed home exercises
15961764|NCT03175250|Behavioral|Health Education|Videos (AIDSvideos.org) were presented on individually-assigned laptops and covered HIV risk, condom use, safe sex, and infection testing
15961765|NCT03175250|Behavioral|Action Plan|Participants selected situations for condom use and screening for HIV and hepatitis on individually-assigned laptops. They linked these situations to preventive behaviors regarding screening and condom use.
15961766|NCT03175250|Behavioral|Memory Practice|Participants engaged in several different types of memory practice procedures on assigned laptops. The procedures focused on memory for action plans for screening and condom use.
15961767|NCT03175237|Other|Mirror Therapy|
15961768|NCT03175224|Drug|APL-101 Oral Capsules|"Phase 1 Subjects will be assigned to a dose level of APL-101 in the order of study entry. Treatment includes 28-day cycles at four planned dose levels (100mg, 200mg, 300mg and 400mg). Each treatment cycle is administered by daily oral capsules taken every 12 hours.
~Phase 2 Subjects will be given 400mg daily dose (200mg BID) of APL-101 capsules."
15961769|NCT03175211|Drug|BI 456906|single dose
15961770|NCT03175211|Drug|Placebo|single dose
15961771|NCT03175198|Drug|Prazaxa Capsules|capsules
15961772|NCT03175172|Biological|CRS-207|Administered by IV infusion over approximately 1 hour.
15961773|NCT03175172|Biological|Pembrolizumab|Administered by IV infusion over approximately 30 minutes.
15961774|NCT03175159|Behavioral|IMPACT|Ten counseling sessions
15961775|NCT03175159|Behavioral|Standard of Care|Two counseling sessions
15961776|NCT03175146|Radiation|Stereotactic Body Radiation Therapy|5 treatments given over 2 weeks
15961777|NCT03175133|Other|Strength exercise|Strengthening exercises performed with physical therapist.
15961778|NCT03175120|Drug|Insulin degludec/liraglutide|Administered subcutaneously (s.c., under the skin) once daily in combination with metformin for the treatment duration of 26 weeks.
15961779|NCT03175120|Drug|Insulin degludec|Administered subcutaneously (s.c., under the skin) once daily in combination with metformin for the treatment duration of 26 weeks.
15961780|NCT03175107|Device|Exergaming|
15961781|NCT03175094|Behavioral|Holistic Health Recovery Program for HIV+|Holistic Health Recovery Program for HIV+ (HHRP+) is a CDC-recommended, evidence based behavioral (psychoeducational) group intervention focused on harm reduction principles. The investigators systematically adapted HHRP+ using findings from qualitative interviews with the target population of adult women living with and at-risk for HIV who are justice-involved (on probation, parole, or recently released from prison or jail).
15961782|NCT03175081|Drug|Ropivacaine|Patient undergo elective laparoscopic sleeve gastrectomy will receive 20mL of 150mg ropivacaine (0.75%) diluted in 180mL normal saline to be injected through a catheter along the greater curvature and left subdiaphragmatic region of the stomach at the end of the surgical procedure. After the surgery, the medical doctors or nurses in the ward that is not otherwise involved in this research will assess and record the pain score using visual analog scale (VAS) (0-10). The abdomen and shoulder tip pain intensity will be rated at two, four, six, eight, 24 and 48 hours postoperatively.
15961783|NCT03175081|Drug|Normal saline|Patient undergo elective laparoscopic sleeve gastrectomy will receive 200mL normal saline to be injected through a catheter along the greater curvature and left subdiaphragmatic region of the stomach at the end of the surgical procedure. After the surgery, the medical doctors or nurses in the ward that is not otherwise involved in this research will assess and record the pain score using visual analog scale (VAS) (0-10). The abdomen and shoulder tip pain intensity will be rated at two, four, six, eight, 24 and 48 hours postoperatively.
15961784|NCT03175068|Behavioral|CBT|CBT works by changing people's attitudes and their behavior by focusing on the thoughts, images, beliefs and attitudes that are held (a person's cognitive processes) and how these processes relate to the way a person behaves, as a way of dealing with emotional problems.
15961785|NCT03175068|Behavioral|ST|Treatment designed to improve, reinforce, or sustain a patient's physiological well-being or psychological self-esteem and self-reliance
15961786|NCT03175055|Device|Phoenix|The study to assess safety and efficacy of Phoenix medical exoskeleton.
15961787|NCT03175042|Device|Masimo spot hemoglobin non-invasive monitor|This non-invasive monitor measures hemoglobin using LED light technology. We will be using it to determine if it is as accurate as routine CBC in anemic obstetric patients.
15961788|NCT03175029|Drug|TAC-302|TAC-302 200 mg administered orally twice per day after meals, for 12 weeks.
15961789|NCT03175029|Drug|Placebo|Placebo administered orally twice per day after meals, for 12 weeks.
15961790|NCT03175016|Procedure|TACE|Transcatheter arterial chemoembolization（TACE）is a minimally invasive procedure performed to restrict a tumor's blood supply.
15961791|NCT03175016|Drug|Irinotecan|Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in eluting-beads and injected in the tumor.
15961792|NCT03175016|Device|eluting-bead|The eluting-bead,loaded with irinotecan (DEBIRI) to treat patients with hepatic metastases from colorectal cancer.
15961793|NCT03175003|Other|Food Product|Each food product will provide similar calories, but a different micro- and macro-nutrient composition
15961794|NCT03174977|Drug|18F-Raltegravir|A single microdose of 18F-Raltegravir will be given to individuals currently being treated for HIV-1 with antiretroviral therapy.
15961795|NCT03174964|Drug|IVIg|Patients will take a dose of 400mg/kg of IVIg 2 days before ET.
15961796|NCT03174951|Drug|IVIg|Patients will take 400mg/kg IVIg at the time of positive pregnancy,Following the first administration, IVIG well given every 4 weeks through 32 weeks of gestation.
15961797|NCT03174938|Diagnostic Test|Flutemetamol F18 Injection|PET imaging of Abeta amyloid
15961798|NCT03174938|Diagnostic Test|[18F]-RO6958948|PET imaging of Tau aggregates
15961799|NCT03174938|Diagnostic Test|Elecsys (Roche) Abeta42, Ttau and Ptau|Measurement of Abeta42, Ttau and Ptau in the cerebrospinal fluid
15961800|NCT03174938|Diagnostic Test|Lumipulse (Fujirebio) Abeta42, Ttau and Ptau|Measurement of Abeta42, Ttau and Ptau in the cerebrospinal fluid
15961801|NCT03174925|Device|Siemens Acuson S3000 ultrasound system|Shear Wave Elastography
15961802|NCT03174912|Procedure|Intravesical BCG instillation|ıntravesical BCG instillations were done two weeks after transurethral resection of bladder cancer
15962157|NCT03172325|Drug|Prednisolone|7.5 mg Prednisolone is daily administered to all the patients.
15961803|NCT03174899|Radiation|Diffusion weighted magnetic resonance imaging|All MRI examinations will be performed with a 1.5-T scanner (Acheiva, Philips, and Netherland). All MRI scans will be obtained with the following parameters: Repetition time (TR); 1580 MS, echo time (TE); 60 MS, slice thickness; 1-5 mm, receiver bandwidth; 1158 kHz/pixel, field of view (FOV); 40 cm, matrix size; 164 × 159. ADC value of the kidneys will be calculated with Diffusion weighted magnetic resonance imaging gradient b-values of 0 and 1000s/mm2. In the axial ADC map, a region of interest (ROI) will be placed for measurement of ADC values on the renal parenchyma of both kidneys, without any preference for cortex or medulla. Three circular ROIs of size 1 cm2 will be placed-one each at the upper pole, inter-polar region, and lower pole of both kidneys-and 6 total ROIs from bilateral kidneys will be averaged for each patient.
15961804|NCT03174886|Drug|AADvac1 40 µg|Active immunotherapy against neurofibrillary pathology.
15961805|NCT03174886|Drug|AADvac1 160 µg|Active immunotherapy against neurofibrillary pathology.
15961806|NCT03174873|Procedure|laparoscopy|Laparoscopy will be done for unexplained infertile couples before starting IVF because not all pathologic lesions that discovered by laparoscope need IVF and so, protect patients from unneeded IVF program
15961807|NCT03174860|Drug|Diclofenac Potassium 50mg Tab|A 50 mg tablet of the medication to be taken one hour before initiation of endodontic treatment.
15961808|NCT03174860|Drug|Placebo|A placebo will be taken one hour before initiation of endodontic treatment.
15961809|NCT03174847|Procedure|Adrenalectomy|Adrenalectomy for unilateral adrenal hyperplasia / adenoma
15961810|NCT03174847|Drug|Mineralocorticoid Receptor Antagonists|Medical treatment with MRA / amiloride
15961811|NCT03174834|Other|Bladder Stimulation technique|The bladder stimulation technique is performed following genital cleaning with a 2% castile soap towelette, which is part of the sterile clean catch urine collection cup kit. For the technique, infants will be held under their armpits by a parent over the bed, with legs dangling in males and hips flexed in females. The nurse or technician will then alternate between bladder stimulation maneuvers: gentle tapping in the suprapubic area at a frequency of 100 taps per minute for 30 seconds followed by lumbar paravertebral massage maneuvers for 30 seconds. These two stimulation maneuvers will be repeated until micturition begins, or for a maximum of 300 seconds.
15961812|NCT03174821|Device|Insulin pump|Blood glucose management device
15961813|NCT03174808|Behavioral|Mindfulness-Based Stress Reduction (MBSR)|Participants will attend weekly 2.5-hour group sessions (of 10-14 persons) based on the standard MBSR protocol.
15961814|NCT03174795|Drug|RO7079901|Participants will receive RO7079901 2000 milligrams (mg) IV treatment, three times a day (TID) for up to 14 days.
15961815|NCT03174795|Drug|Meropenem|Participants will receive meropenem 2000 mg IV treatment TID for up to 14 days.
15961816|NCT03174782|Drug|Bupivacaine|Patients randomized to the treatment group will receive regional nerve blocks (sciatic and femoral) with bupivacaine at the dose of 1 mg/kg.
15961817|NCT03174782|Drug|Saline Solution|Patients randomized to the control group will receive two needle sticks (in the sciatic and femoral distributions) with normal saline to maintain the double-blinded investigation.
15961818|NCT03174769|Other|Normal protein|Following a two week baseline assessment period, subjects will consume a diet with normal protein diet while undergoing weight loss for 12 wk.
15961819|NCT03174769|Other|High protien|Following a two week baseline assessment period, subjects will consume a diet with high protein diet while undergoing weight loss for 12 wk.
15961820|NCT03174756|Drug|Hypochlorous Acid|Mouthwashes of antiplaque agents
15961821|NCT03174756|Drug|Chlorhexidine|A disinfectant and topical anti-infective agent used also as mouthwash to prevent oral plaque.
15961822|NCT03174756|Other|Placebo|Sterile water as placebo
15961823|NCT03174743|Procedure|Convential Ventilation 1|High tidal volume, moderate inspired oygen fraction (FiO2).
15961824|NCT03174743|Procedure|Convential Ventilation 2|High tidal volume, high inspired oygen fraction (FiO2).
15961825|NCT03174743|Procedure|Protective Ventilation 1|Low tidal volume, PEEP, moderate inspired oygen fraction (FiO2) and recruitment maneuver.
15961826|NCT03174743|Procedure|Protective Ventilation 2|Low tidal volume, PEEP, High inspired oygen fraction (FiO2) and recruitment maneuver.
15961827|NCT03174730|Behavioral|Growth Mindset|The intervention is aimed at creating more flexible thinking about addiction to tobacco. Participants will be sent tips by email to help foster the belief that people can overcome addiction to smoking.
15961828|NCT03174730|Behavioral|SmartQuit|This is an Acceptance and Commitment Therapy based intervention designed a smoking cessation smartphone application.
15961829|NCT03174717|Behavioral|Music performance|residents of LTC will learn and perform songs with musicians from the community
15961830|NCT03174691|Diagnostic Test|Blood collection|"A total of ten (10) blood samples (2ml/each) will be collected during the study.
~Blood samples will be collected on the following days for subsequent analysis of LH, Estradiol, hCG, progesterone and 17-Hydroxyprogesterone."
15961831|NCT03174678|Drug|Dexmedetomidine|1µg/kg dexmedetomidine oral
15961832|NCT03174678|Other|apple juice|apple juice
15961833|NCT03174665|Other|No intervention|
15961834|NCT03174639|Procedure|Inverted and free ILM insertion|ILM was peeled and the ILM flap was inverted and inserted into the macular hole, followed by insertion of free ILM flap.
15961835|NCT03174626|Behavioral|WLSCC|"Briefly, WLSCC contents are as follows: Psychosocial skill 1: Increase objectivity and awareness of thoughts and feelings in a distressing situation and learning the technique of a log entry; Psychosocial skill 2: Evaluate the situation to decide whether to change one's reactions or to take actions; Psychosocial skill 3: Increase the positive and the sense of meaning in your life; Psychosocial skill 4: Deflection strategies; Psychosocial skill 5: Take action when action is called for; Psychosocial skill 6: Assertion; Psychosocial skill 7: Saying No; Psychosocial skill 8 : Communication; Psychosocial skill 9: Become a better listener; Psychosocial skill 10: Empathy."
15961836|NCT03174626|Other|Usual Care|No training provided. After data collection period is over, participants have the option to receive the WLSCC training
15961837|NCT03174613|Drug|LC51-0255|0.25mg, 0.5mg, 1mg, 2mg, 4mg, 8mg
15961838|NCT03174613|Drug|Placebo|0.25mg, 0.5mg, 1mg, 2mg, 4mg, 8mg
15961839|NCT03174600|Other|Questionnaire|The patients were questioned using the Danish Prostatic Symptom Score (DAN-PSS), and evaluated using modified Barthel index, incontinence quality of life questionnaire (I-QOL), and the Mini-Mental Test (MMT) on the 1st, 3rd and 6th months.
15961840|NCT03174587|Biological|allogenic bone marrow derived mesenchymal stem cells|Step -1 dose : 1.0x10^6cells/kg Step 1 dose : 2.0x10^6cells/kg Step 2 dose : 3.0x10^6cells/kg The single injection of CS20AT04 Inj. in the peripheral veins.(IV) The duration of follow up study following the single dose of CS20AT04 is 28 days
15961841|NCT03174561|Dietary Supplement|Inuline, Choline and Silymarin|Combination of one sachet: Inuline (5000 mg), Silybum marianum seed extract (50 mg), Choline (37 mg) The dose: 1 sachet first 7 days and 1 sachet x 2 times daily for the next 21 days. Diet restriction is consider together with dietary supplement intake.
15961842|NCT03174561|Other|diet restriction|diet restriction for 28 days
15961843|NCT03174548|Drug|Sotagliflozin (SAR439954)|"Pharmaceutical form: tablet
~Route of administration: oral"
15961844|NCT03174548|Drug|Sotagliflozin (SAR439954)|"Pharmaceutical form: solution
~Route of administration: oral"
15961845|NCT03174522|Drug|REX-001|REX-001 is administered through an intra-arterial catheter.
15961846|NCT03174522|Drug|Placebo|Placebo is administered through an intra-arterial catheter.
15961847|NCT03174509|Procedure|Positive pressure extubation|Positive pressure ventilation without endotracheal aspiration/suction during extubation procedure.
15961848|NCT03174509|Procedure|Traditional during extubation|Spontaneous ventilation with endotracheal aspiration/suction during extubation procedure.
15961849|NCT03174483|Drug|Hypertonic saline|nasal spray
15961850|NCT03174483|Drug|Fluticasone Nasal|nasal spray
15961851|NCT03174470|Device|TENS Stimulator|Initial stimulation of arm (conditioning) followed by Increasing Intensities of Electrical Stimulation Delivered to The Bulbospongiosus Muscle
15961852|NCT03174457|Drug|Micafungin|Intravenous
15961853|NCT03174444|Behavioral|Small Media|Bilingual brochures and access to bilingual website
15961854|NCT03174431|Device|Continence Pessary|Continence pessaries are inexpensive, reusable intravaginal devices made of flexible silicon that provide support to the urethra to prevent urinary leakage. Continence pessaries are fitted by trained clinicians in the office and managed by patients or their provider.
15961855|NCT03174431|Device|Poise Impressa (Disposable Intravaginal Device)|In 2014, the FDA approved an over-the-counter disposable intravaginal device as another nonsurgical treatment for SUI. This device is comprised of 4 support poles covered in a non-absorbable nylon mesh that is deployed using an intravaginal applicator.
15961856|NCT03174418|Procedure|Coronary angiography and optical coherence tomography|Coronary angiography and OCT images will be combined to obtain a three-dimensional model of the diseased coronary vessels that will be used to calculate the local blood flow patterns and the arterial time-averaged wall shear stress at the bifurcated lesion level
15961857|NCT03174405|Drug|Avelumab|"All eligible patients will receive cetuximab and mFOLFOX6 combined avelumab from the second cycle onwards.
~Cetuximab at a dose of 250 mg/m2 IV over 60 to 90 min (day 1 and 8) (first dose 400mg/m2) mFOLFOX6 (administration according to local standard) Oxaliplatin at a dose of 85 mg/m2 IV (day 1) 5-FU 400 mg/m2 IV bolus (day 1) LV at a dose of 400 mg/m2 iv (day 1) 5-FU at a dose of 2400 mg/m2 IV (day 1-3) Avelumab at a dose of 10mg/kg IV over 60 to 90 min (day 1 from cycle 2 onwards)"
15961858|NCT03174392|Other|Resistance Based Training|Resistance based training study: Each training session will begin by determining the treadmill walking speed that an individual will train. The speed of the treadmill will be incrementally increased stepwise and individuals will affirm which speed feels the most comfortable to walk. Thus, the training speed of individuals will not necessarily be fixed over the 8-week study. Heart rate will be monitored and resistive force will be applied stepwise until the heart rate reaches at least 60% heart rate reserve. Individuals will be encouraged to walk at least five minutes and then allowed to rest. Achieved heart rate reserve and time the spent training at 60-80% heart rate reserve will be quantified for each session. Subjective measures of effort will also be sampled using the Borg Scale.
15961859|NCT03174392|Other|Speed Based Training|Speed based training study: Individuals will train at the fastest walking speed that an individual asserts that they can maintain for five minutes. The training time will then begin. Individuals will be encouraged to walk at least five minutes and then be allowed to rest. Speed will be progressed for each individual every 1-2 weeks at increments between 0.02 m/s and 0.08 m/s. Treadmill inclination will remain at 0°. Participants will be allowed to use the handrail or forearm support while being encouraged to walk without support if possible. Achieved heart rate reserve and the time the spent training at 60-80% heart rate reserve will be quantified for each session. Subjective measures of effort will also be sampled using the Borg Scale.
15961860|NCT03174379|Procedure|Standard of Care with no acupuncture|The control group will lie on a treatment table in the acupuncturist's office for the same amount of time that the treatment group did, but receive no acupuncture
15961861|NCT03174379|Procedure|Acupuncture|The first set consists of core point selection, used in an MS Standard of Care (SOC). The second set of points will be individualized to the patient's needs as determined by the acupuncturist. SOC treatment will be based upon Traditional Chinese Medicine (TCM) interpretation of 4 phases of MS.
15961862|NCT03174366|Drug|Denosumab|Subjects will receive medication once following enrollment, and will be monitored for 1 year thereafter.
15961863|NCT03174353|Drug|Lanreotide Prefilled Syringe|All patients enrolled in this study will receive SOMATULINE DEPOT 120 mg immediately prior to planned pancreatic resection. The pharmacist will dispense loaded syringes of the study drug. The single preoperative dose will be given in the pre-surgical center at the University of Washington by a trained health care professional. The study drug will be injected via the deep subcutaneous route in the superior external quadrant of the buttock.
15961864|NCT03174340|Behavioral|Exercise|Once per week, participants will be enrolled in supervised group exercise intervention. They will be encouraged in walking 45 minutes per day
15961865|NCT03174327|Diagnostic Test|Hepatic Transplantation|Systematic long-term monitoring of liver transplant patients includes an annual consultation and more comprehensive follow-up at one year, 5 years and 10 years of transplantation during which patients are hospitalized in day hospital hepatology and have a clinical examination Complete, biological assessment, Fibroscan® graft elastography measurement, hepatic Doppler ultrasound and liver biopsy. Measurement of liver stiffness by SuperSonic® will be added during ultrasound.
15961987|NCT03173547|Drug|Vehicle cream|Vehicle cream does not contain an active drug and is applied topically.
15962154|NCT03172325|Drug|Adalimumab|40 mg Adalimumab every other week is administered subcutaneously to all the patients.
15961866|NCT03174314|Behavioral|standard object battery and training sequence|Used to examine human localization and identification performance. Object battery will include: trip hazards ('pucks' with various height/width combinations to represent children's toys, street debris, rocks, pets, etc.), furniture (chairs, desks, couches, benches), people, walls, and corridors. Objects will be recorded by placing them to the right or left on the path-of-travel. Raw sensor outputs for single obstacles and walls in isolation (trip-hazard pucks with 8 heights, chair, desk, person, wall) and the same set of single obstacles against a wall. This set of 23 raw sensor traces can be used in various combinations (e.g., encountering a curb and then a person, or a chair) to create a training sequence that will help experimentally naïve subjects to understand the correspondence between tactile stimulation and the real-world scenario it is intended to depict.
15961867|NCT03174288|Other|Exercise|24 weeks of exercise treatment
15961868|NCT03174288|Drug|Spironolactone|24 weeks of spironolactone
15961869|NCT03174275|Drug|Durvalumab|Subjects will receive durvalumab, 750 mg every 2 weeks by IV infusion over approximately 1 hour (± 5 minutes).
15961870|NCT03174275|Drug|Carboplatin|Carboplatin is commercially available and approved by the US FDA for use in patients with ovarian cancer.
15961871|NCT03174275|Drug|Nab-paclitaxel|Nab-paclitaxel is commercially available and approved by the US Food and Drug Administration (FDA) for use in patients with metastatic breast cancer, metastatic pancreatic cancer, and for the treatment of locally advanced or metastatic NSCLC.
15961872|NCT03174275|Drug|Cisplatin|Cisplatin is commercially available and approved by the US Food and Drug Administration (FDA) for the treatment of advanced bladder, ovarian and testicular cancer. It has been widely studied in a variety of solid tumor types.
15961873|NCT03174275|Procedure|Surgical resection|Surgical therapy will be at the discretion of the treating surgeon per standard of care.
15961874|NCT03174275|Radiation|IMRT|"involved field radiation will refer to areas demonstrated to harbor disease on pathology, and not elective areas"
15961875|NCT03174262|Behavioral|Ergonomic Computer Workstation Training|Training in proper body alignment and use of computer at computer workstations for people who spend 30% or more of a typical day at a computer. Training consists of learning proper positioning for head, neck, shoulders, arms, hands, and legs; proper arrangement of computer monitor, keyboard, mouse, and accessories.
15961876|NCT03174249|Behavioral|Exposure therapy|Daily training at an in-patient ward during four plus four weeks, separated by a home training period of 6-8 weeks.
15961877|NCT03174236|Drug|Ceftriaxone|Ceftriaxone a third-generation cephalosporin. Ceftriaxone is active against a broad spectrum of Gram positive and Gram negative bacteria.
15961878|NCT03174236|Drug|Benzyl penicillin|The currently recommended first-line antibiotics for the treatment of severe acute malnutrition are gentamicin plus ampicillin or penicillin.
15961879|NCT03174236|Drug|Metronidazole|"The WHO guidelines recommend that Metronidazole may be given in addition to broad-spectrum antibiotics, however, the efficacy of this treatment has not been established in clinical trials."
15961880|NCT03174236|Other|Placebo|Suspension manufactured to match metronidazole
15961881|NCT03174236|Drug|Gentamicin|The currently recommended first-line antibiotics for the treatment of severe acute malnutrition are gentamicin plus ampicillin or penicillin.
15961882|NCT03174223|Drug|deep neuromuscular block|a continuous dosing of rocuronium is used to achieve neuromuscular block of 1-2 twitches post tetanic count
15961883|NCT03174210|Device|liquid oxygen device (LOD)|This oxygen Supplementation is used in special order
15961884|NCT03174210|Device|portable oxygen concentrator (POC)|This oxygen Supplementation is used in special order
15961885|NCT03174197|Drug|Atezolizumab|Given IV
15961886|NCT03174197|Radiation|Radiation Therapy|Undergo RT
15961887|NCT03174197|Drug|Temozolomide|Given PO
15961888|NCT03174184|Drug|Rifampin|Oral administration of rifampin at a dosage of 20 mg/kg daily
15961889|NCT03174184|Drug|MEROPENEM 2 grams TID|Intravenous administration at a dosage of 2 grams thrice daily
15961890|NCT03174184|Drug|MEROPENEM 1 gram TID|Intravenous administration at a dosage of 1 gram thrice daily
15961891|NCT03174184|Drug|MEROPENEM 3 grams QD|Intravenous administration at a dosage of 3 grams once daily
15961892|NCT03174184|Drug|Amoxicillin/Clavulanate Potassium 500 MG-125 MG Oral Tablet|Amx/Clv will be administered orally at a dose of 500 mg/125 mg thrice daily
15961893|NCT03174184|Drug|Amoxicillin/Clavulanate Potassium 875 MG-125 MG Oral Tablet|Amx/Clv will be administered orally at a dose of 875 mg/125 mg once daily
15961894|NCT03174171|Drug|Everolimus 0.75 mg|Everolimus 0.75 mg b.i.d. orally for 14 days.
15961895|NCT03174158|Drug|Mailed nicotine replacement therapy|Daily smokers will be offered patches and lozenges dosed according to package instructions (patches dosed according to cigarettes smoked per day and lozenges dosed according to time to first cigarette). Non-daily smokers will be offered a 2 week supply of 2 mg lozenges. Smokers not ready to quit will be offered one box of lozenges dosed according to time to first cigarette to use in a practice quit attempt.
15961896|NCT03174158|Behavioral|Text messaging|12 week text messaging program tailored to readiness to quit and quit date. Program includes content encouraging NRT use. Content is personalized with user's name and Massachusetts General Hospital resources.
15961897|NCT03174158|Behavioral|Brief advice|Brief advice delivered by telephone by a clinical research coordinator who underwent Tobacco Treatment Specialist core training
15961898|NCT03174145|Behavioral|Positive behaviour|Information about T4P1010 treatment
15961899|NCT03174145|Drug|T4P1010 administration|Provide treatment to be taken twice a day between Visit 2 and Visit 5 as add-on therapy to patient's regular analgesic treatment
15961900|NCT03174145|Genetic|Pharmacogenetic|Blood sample of 10 millilitres maximum
15961901|NCT03174145|Other|Questionnaires and diary completion|Personality, pain and disease questionnaires completion during the study Diary completion between Visit 1 and Visit 5
15961902|NCT03174132|Device|Restylane Perlane Lidocaine|Intradermal injection
15961903|NCT03174132|Device|Restylane Perlane|Intradermal injection
15961904|NCT03174119|Device|Light therapy - active|Active light will be used for one week, as compared to placebo light.
15961905|NCT03174119|Device|Placebo light|Placebo light will be used for one week, as compared to real light exposition.
15961906|NCT03174106|Device|Smartphone-Application|Longterm follow-up after Cardiac rehabilitation With an Smartphone-Application
15961907|NCT03174093|Behavioral|MATCh AFib application|The application comprehends five steps: (1) An educational video about how AF can cause stroke; (2) A calculator of risk scores (CHA2DS2-VASc, HAS-BLED and SAMe-TT2R2); (3) A screen with pictograms to allow better understanding of the scores by patients and to demonstrate how much each anticoagulant can decrease stroke risk or increase bleeding risk; (4) A summary about types of medications available, and (5) An output formulary in which the physician can register patient's contact to continue receiving information about atrial fibrillation and anticoagulation through SMS. Physicians can save patient's history of INR tests and previous doses of anticoagulation prescribed and also use a calculator to adjust the dose.
15961908|NCT03174080|Radiation|FDG (glucose labeled isotope of fluorine)|Patients will receive an intravenous injection of 2-5mCi of 18F-FDG prior to PET MRI
15961909|NCT03174067|Drug|Buprenorphine|The participant receives buprenorphine
15961910|NCT03174067|Drug|Clonidine|The participant receives clonidine
15961911|NCT03174054|Procedure|Biopsy|Biopsies are part of standard procedures in the patients recruited and will not be done due to this study.
15961912|NCT03174041|Drug|Midazolam|Single dose midazolam
15961913|NCT03174041|Drug|GDC-0853|Multiple doses GDC-0853 for 6 days
15961914|NCT03174041|Drug|Midazolam and GDC-0853|Multiple doses GDC-0853 and single dose midazolam
15961915|NCT03174041|Drug|Rosuvastatin|Single dose rosuvastatin
15961916|NCT03174041|Drug|Rosuvastatin and GDC-0853|Multiple doses GDC-0853 and single dose rosuvastatin
15961917|NCT03174041|Drug|Simvastatin|Single dose simvastatin
15961918|NCT03174041|Drug|Simvastatin and GDC-0853|Multiple doses GDC-0853 and single dose simvastatin
15961919|NCT03174041|Drug|GDC-0853|Single dose GDC-0853
15961920|NCT03174041|Drug|Itraconazole|Multiple doses itraconazole for 6 days
15961921|NCT03174041|Drug|GDC-0853 and itraconazole|Multiple doses itraconazole and single dose GDC-0853
15961922|NCT03174028|Device|laparoscopic pull-through|laparoscopic pull-through
15961923|NCT03174015|Behavioral|Bauleni Secret|The intervention will invite enrolled landlords to a series of meetings in which various mechanisms will be used, each designed to increase their likelihood of improving the toilet(s) on their plot. These meetings will be the main vehicle for a status-building campaign associated with increasing wealth by improving plot sanitation, understanding tenants' implicit demand, understanding the processes by which toilets can be improved, and a competition rewarding landlords that make the greatest improvements to the improvement of their toilet(s).
15961926|NCT03173989|Device|Orthosis Exercises Orientation|Use of orthosis, exercises and orientation for home.
15961927|NCT03173989|Behavioral|Orientation|Orientation for home.
15961928|NCT03173976|Drug|Zoledronic Acid|Zoledronic acid, a member of bisphosphonate class, inhibits bone resorption.
15961929|NCT03173963|Drug|Empagliflozin|10 mg tablet of empagliflozin daily in addition to best clinical practice for management of diabetes.
15961930|NCT03173963|Other|Placebo|1placebo tablet per day
15961931|NCT03173950|Drug|Nivolumab|Participants will receive nivolumab at standard dose of 240mg IV every 2 weeks for cycles 1 through 2, then doses of 480mg every 4 weeks for a total of 14 additional doses
15961933|NCT03173924|Drug|18F-NaF|Baseline IV followed by PET/CT IMAGING
15961934|NCT03173924|Drug|18F-DCFPyL|Baseline IV followed by PET/CT IMAGING. Additional 18F-DCFPyL PET/CTs might be performed during the subject s follow up period if, in the opinion of the referring clinician, there has been a considerable change in patient status (progression or response) based on clinical grounds/PSA value or to help assess changes of standard of care therapy.
15961935|NCT03173924|Drug|18F-FDG|Baseline IV followed by PET/CT IMAGING. Additional 18F-FDG PET/CTs may be obtained per PI discretion within a 21-day window relative to each 18F-DCFPyL PET/CTs.
15961936|NCT03173911|Device|Bandage|Application of Elastic Bandage Therapy by the Therapy Taping method
15961937|NCT03173898|Procedure|PDL anesthesia versus local infiltration|Every patient received the recommended volumes of 2% lidocaine with 1:100.000 epinephrine for PDL injection on the experimental side, and for local infiltration on the control side. A Visual Analogue Scale (VAS) was used to describe the pain felt during injection.
15961938|NCT03173885|Diagnostic Test|Preimplantation Genetic Screening|"laser assisted hatching
~trophectoderm biopsy
~next generation sequencing"
15961939|NCT03173872|Procedure|Reiki Protocol Hand Placement Procedures|Ten Reiki hand placement procedures will last 3 minutes each for a total Reiki session lasting 30 minutes long.
15961940|NCT03173859|Drug|Abiraterone|Abiraterone acetate 1000mg qD and prednisone 5mg bid administered orally
15961941|NCT03173859|Drug|Apalutamide|apalutamide 240mg qD orally
15961942|NCT03173833|Other|CAGO questionnaire outcome|Every time when cancer patients fulfill the following questionnaires, SDS, PTGI, CNS, PedsQL, the outcome of the questionnaires will be provided to the experimental group of the participants by using a computer assessment with graphic outcome.
15961943|NCT03173820|Genetic|Genotype guided|Tacrolimus will be prescribed depend on CYP3A5 genotype. CYP3A5*1/*1 patients will receive tacrolimus 0.125 mg/kg/day. CYP3A5*1/*3 patients will receive tacrolimus 0.1 mg/kg/day. CYP3A5*3/*3 patients will received tacrolimus 0.08 mg/kg/day. Tacrolimus target level for this phase will be 5-8 ng/ml.
15961944|NCT03173820|Genetic|Conventional|Tacrolimus will be prescribed 0.1 mg/kg /day for all patients to achieve tacrolimus level 5-8 ng/ml.
15961945|NCT03173807|Behavioral|diet and exercise guidance and modifications|Review of diet, food diary, and guidance from the dietician; review of activity journal, assessment of body composition, tests for gait, balance and muscle strength, and new assignment from the exercise trainer
15962064|NCT03172988|Drug|Dexamethasone|Dexamethasone 10 mg is administered before anesthesia induction.
15961946|NCT03173794|Other|CommunityRx-H|"CommunityRx-H has two components: (1) health-information technology (HIT) e-prescribing, and (2) a Community Resource Specialist (CRS). CommunityRx functions like an e-prescribing system: a HealtheRx prescription is automatically generated at the point of care. The HealtheRx provides referrals to food resources and federal nutrition assistance information tailored to the caregiver's address and proactive social support in the form of SMS-text message nudges from the CRS. Caregivers in the intervention arm are able to request information on resources not limited to food, including employment support, help paying rent or mortgage, etc. Nudges will promote caregiver self- and family management by increasing knowledge of and encouraging activation of community resources."
15961947|NCT03173781|Drug|droxidopa|medication
15961948|NCT03173781|Drug|Placebo|medication
15961949|NCT03173768|Procedure|ID specialist approval|Appropriateness of intravenous antibiotics ordered by the primary team was assessed by ID specialist. ID fellow modified the intravenous antibiotics ordered by the primary team if those intravenous antibiotics were judged as inappropriate by ID fellow as follows: 1) discontinue intravenous antibiotics (treatment was complete), 2) switch to oral antibiotics, 3) change intravenous antibiotics to cover isolated pathogens, 4) adjust the dose of intravenous antibiotics, and 5) change the duration of intravenous antibiotics. Finally, ID specialist retrospectively assessed the appropriateness of intravenous antibiotics at hospital discharge managed by ID fellow in post-intervention period.
15961950|NCT03173742|Drug|T1, T2, T3|"T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight.
~T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)"
15961951|NCT03173742|Drug|T1,T3,T2|"T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight.
~T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)"
15961952|NCT03173742|Drug|T2,T1,T3|"T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight.
~T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)"
15961953|NCT03173742|Drug|T2,T3,T1|"T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight.
~T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)"
15961954|NCT03173742|Drug|T3,T1,T2|"T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight.
~T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)"
15961955|NCT03173742|Drug|T3,T2,T1|"T1: Ivermectin 6 mg (Revectina®) administered according to the SmPC by body weight.
~T2: Ivermectin 18 mg (IVM 18 mg Tablet Liconsa x 1 tablet) T3: Ivermectin 36 mg (IVM 18 mg Tablet Liconsa x 2 tablets)"
15961956|NCT03173729|Diagnostic Test|Biosensor Point of Care Device|This device is a point of care urine-based metabolomic diagnostic test that detects metabolite biomarkers for CRC and polyps.
15961957|NCT03173716|Procedure|Definity|Real-Time Myocardial Perfusion Echocardiography (RTMPE) will be performed as opposed to the standard echocardiogram (TTE) of the control arm
15961958|NCT03173703|Device|Implant the XenoSure patch|The LeMaitre XenoSure patch will be used when close the repaired vessel
15961959|NCT03173703|Procedure|Repair/reconstruction of the diseased vessel|The diseased vessel is surgically repaired such as removing the clots.
15961960|NCT03173703|Device|Implant the Vascular-Patch|The B. Braun Vascular-Patch will be used when close the repaired vessel
15961961|NCT03173690|Other|Medication reconciliation at the ICU|Medication reconciliation performed according to Integrated Medicines Management model
15961962|NCT03173690|Other|Medication Reconciliation at the Ward|Medication reconciliation performed according to Integrated Medicines Management model
15961963|NCT03173677|Dietary Supplement|Lipid Intake|90 grams whipping cream, 31.5 grams fat, 1.7 grams protein, and 2.25 grams carbohydrate
15961964|NCT03173677|Dietary Supplement|Glucose intake|300 calories of glucose
15961965|NCT03173677|Dietary Supplement|Protein intake|Isopure unflavored Whey proteins isolate (WPI) powder containing 26 grams per serving of 100% WPI, stripped of fat, carbs, fillers, sugars, and lactose
15961966|NCT03173664|Device|KAMRA Inlay|Unilateral implantation of the KAMRA inlay in the corneal stroma.
15961967|NCT03173651|Device|Modified Williams airway|This airway used as a conduit for fiberoptic bronchoscopic tracheal intubation in Group W
15961968|NCT03173651|Device|Modified Guedle's airway|This airway used as a conduit for fiberoptic bronchoscopic tracheal intubation in Group G
15961969|NCT03173651|Device|LMA MADgic airway|This airway used as a conduit for fiberoptic bronchoscopic tracheal intubation in Group M
15961970|NCT03173638|Procedure|intravitreal injection of MSV|A unique intravitreal injection of MSV in acute fase of NAION
15961971|NCT03173625|Drug|AC-076 for s.c. administration|Lyophilized AC-076A to be reconstituted with 1 mL of water for injection
15961972|NCT03173625|Drug|Placebo|Sterile 0.9% w/v sodium chloride solution
15961973|NCT03173612|Drug|Dasatinib|Primary AML includes CBF-AML and non-CBF-AML. Children with a WBC (white blood cell) lower than 4,000/μL and low proliferative bone marrow at diagnosis are treated with CAG. Other children are treated with MAE. The rescue regimen for children who showed M3 marrow after MAE or CAG is IAE. Consolidation therapy consisted of four (for CBF-AML) or five (for non-CBF-AML) courses, and triplein trathecal therapy is given as a part of each course. After the second course of therapy, CBF-AML are stratified into two risk groups, while non-CBF-AML patients in remission are stratified into three risk groups.Consolidation regimen for CBF-AML includes IA, MA, IA, MA. Dasatinib is used in CBF-AML as a part of consolidation therapy. Consolidation regimen for non-CBF-AML includes IAE, MAE, EA, IAE, EA or MAE.
15961974|NCT03173599|Drug|PNA 40mg|The beginning dose is 40mg.
15961975|NCT03173599|Drug|PNA 80mg|The single dose is 80mg.
15961976|NCT03173599|Drug|PNA 160mg|The single dose is 160mg.
15961977|NCT03173599|Drug|PNA 240mg|The single dose is 240mg.
15961978|NCT03173599|Drug|PNA 360mg|The single dose is 360mg.
15961979|NCT03173599|Drug|PNA 480mg|The single dose is 480mg.
15961980|NCT03173599|Drug|PNA Placebo|The beginning dose is 40mg/d, the dose escalation method is 40mg/80mg/160mg/240mg/360mg/480mg.
15961981|NCT03173586|Other|Sugar sweetened beverage (SSB)|This is an observational study examining sugar sweetened beverage intake in relation to biomarkers in the NHS.
15961982|NCT03173573|Drug|FDL176|CFTR modulator
15961983|NCT03173573|Drug|Placebo|Placebo for FDL176
15961988|NCT03173534|Device|WATCHMAN|WATCHMAN Device is composed of a self-expanding nitinol structure with a porous membrane on the proximal face. The implant device is delivered to the Left Atrial Appendage by femoral venous access and transseptal puncture to enter the left atrium.
15961989|NCT03173534|Device|TAVR|Transcatheter Aortic Valve Replacement
15961990|NCT03173521|Biological|AAV2/8.TBG.hARSB|"Adeno-associated viral vector serotype 8 with liver-specific thyroxinebinding globulin (TBG) promoter driving the expression of the human ARSB gene. Three dose levels are available:
~Starting dose is 6x1011 gc of vector per kg of body weight.
~High dose is 2x1012 gc of vector per kg of body weight and will be administered after at least two subjects at the starting dose have experienced no DLT
~Low dose is 2x1011 gc of vector per kg of body weight. Intermediate doses are also possible. The administration of the IMP will be performed into a peripheral vein. The IMP final volume to be injected is calculated based on the patient's weight (determined on the day of hospital admission), as 3 mL/kg."
15961991|NCT03173508|Drug|ACETAZOLAMIDE oral capsule|Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m
15961992|NCT03173508|Drug|Placebo oral capsule|Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m
15961993|NCT03173495|Dietary Supplement|FRUCTOSE|Fructose-rich beverage with a high fat meal, without exercise.
15961994|NCT03173495|Dietary Supplement|DEXTROSE|Dextrose-rich beverage with a high fat meal (control), without exercise.
15961995|NCT03173495|Dietary Supplement|EXERCISE|45 minutes of 60% VO2peak aerobic exercise
15961996|NCT03173482|Other|questionnaire|asking about details of indication of cesarean section
15961997|NCT03173469|Other|magnetic resonance imaging of breast|all patients will undergo preoperative MRI
15961998|NCT03173456|Drug|oxycodone/APAP|Oxycodone/acetaminophen 5 mg-325 mg oral tablet
15961999|NCT03173456|Drug|hydrocodone/APAP|Hydrocodone/Acetaminophen 5 Mg-300 Mg oral tablet
15962000|NCT03173456|Drug|codeine/APAP|Codeine/acetaminophen 30 mg-300mg oral tablet
15962001|NCT03173456|Drug|400 ibuprofen/APAP|ibuprofen/acetaminophen 400 mg-1000mg oral tablet
15962002|NCT03173456|Drug|800 ibuprofen/APAP|ibuprofen/acetaminophen 800 mg-1000 mg oral tablet
15962003|NCT03173443|Device|single lumen tube and bronchial blocker|fiberoptic intubation with single lumen tube and bronchial blocker
15962004|NCT03173443|Device|double lumen tube|fiberoptic intubation with double umen tube
15962005|NCT03173430|Drug|Blinatumomab|Blinatumomab (Blincyto), an anti-CD19/anti-CD3 bi-specific T cell engager
15962006|NCT03173417|Biological|IM19 CAR-T|T Cells Expressing an Anti-CD19 Chimeric Antigen Receptor
15962007|NCT03173417|Drug|fludarabine and cyclophosphamide|Two days before cell infusion,all patients will be treated with fludarabine and cyclophosphamide for 3 days
15962008|NCT03173404|Procedure|Hysteroscopy|The hysteroscopy is the visualization of the cervical canal and uterine cavity with a camera. Patients randomized to group I underwent hysteroscopy prior to the IVF cycle.
15962009|NCT03173391|Drug|HMS5552|BID Oral administration
15962010|NCT03173391|Drug|Placebo|BID Oral administration
15962011|NCT03173378|Other|Questionnaires|Participants will have to complete questionnaires to compare the distribution of occupational situations in narcoleptic patients and matched non-narcoleptic subjects (controls)
15962012|NCT03173365|Drug|Brimonidine Tartrate|1 gram of Brimonidine 3 mg/g gel (Mirvaso®) in 24 hours on the randomized palm equal to a finger tip unit (FTU) of 0.5 gram , topical application under occlusion twice per day, every 12 hours.
15962013|NCT03173339|Procedure|Endotracheal intubation using laryngoscope|Endotracheal intubation was done using laryngoscope for general anesthesia.
15962014|NCT03173339|Drug|High remifentanil|Remifentanil was started as 0.25 mcg/kg/min. Remifentanil dose was adjusted to maintain blood pressure (20% of preoperative blood pressure) and bispectral index (40-60) by 0.05 mcg/kg/min.
15962015|NCT03173339|Drug|Low remifentanil|Remifentanil was administered as 0.1 mcg/kg/min.
15962016|NCT03173339|Drug|High sevoflurane|Sevoflurane was started as 0.5 MAC. Sevoflurane dose was adjusted to maintain blood pressure (20% of preoperative blood pressure) and bispectral index (40-60) by 0.2 %.
15962017|NCT03173339|Drug|Low sevoflurane|Sevoflurane was administered as 0.5 MAC.
15962018|NCT03173326|Procedure|General anesthesia|General anesthesia will be delivered per standard procedure. General anesthesia will include induction with propofol 1-3mg/kg followed by placement of a laryngeal mask airway with maintenance anesthesia of sevoflurane 0.5-1 minimum alveolar concentration (MAC).
15962019|NCT03173326|Procedure|Subarachnoid block|Neuraxial anesthesia will be performed at the L2-3 or L3-4 interspace with a 25-gauge Whitacre needle in the sitting position. After free flow of cerebrospinal fluid (CSF), 40-45mg of 2-chloroprocaine will be injected based on patient's height and discretion of attending anesthesiologist, needle withdrawn and the patient placed supine.
15962020|NCT03173313|Device|Intravascular permissive hypothermia as an adjunct to PCI|Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI) -or- Standard of Care for PCI
15962021|NCT03173287|Procedure|Quantification of liver fibrosis|Procedure MRI and liver biopsy
15962022|NCT03173274|Behavioral|Brief Motivational Intervention|Participants in both groups will be given an BMI intervention in which they will be counseled to quit smoking.
15962023|NCT03173274|Behavioral|Contingency Management|Contingent Reinforcement for negative breath CO samples
15962024|NCT03173274|Behavioral|Non-Contingent Reinforcement|Participants will receive reinforcement for submitting samples ona yoked schedule unrelated to CO sample value [CM control]
15962025|NCT03173261|Diagnostic Test|Genexpert|diagnosis of tuberculous pleural effusion and genitourinary tuberculosis by Genexpert by urine and pus and pleural fluid aspirate
15962026|NCT03173248|Drug|AG-120 (ivosidenib) with Azacitidine|Continuous 28-day cycles of AG-120 (ivosidenib) 500 mg orally (PO) once daily (QD) in combination with azacitidine 75 mg/m2/day SC or IV for the first week of each cycle
15962027|NCT03173248|Drug|Placebo with Azacitidine|Continuous 28-day cycles of Placebo orally (PO) once daily (QD) in combination with azacitidine 75 mg/m2/day SC or IV for the first week of each cycle
15962028|NCT03173235|Diagnostic Test|Plasma level of vitamin D|messurement of plasma level of vitamin D
15962065|NCT03172988|Drug|Normal saline|Normal saline 2 ml is administered before anesthesia induction.
15962029|NCT03173222|Procedure|Electroacupuncture|A combined procedure with acupuncture and electric current stimulation. Local electroacupuncture will be given in group EA 1, while local with distal electroacupuncture will be given in group EA 2.
15962030|NCT03173209|Behavioral|professional development in Calm Moments Cards program|Professional development (lecture and coaching)was used in combination with informal coaching by occupational therapy practitioners to educate school personnel on signs of stress and how to embed evidence based strategies (cognitive behavioral, mindfulness, and sensory) throughout the school day to reduce stress and enhance emotional well-being in students using the Calm Moments Cards program.
15962031|NCT03173196|Device|Non-invasive Multispectral Sonography|We measure both groups wirh the non-invasive multispectral sonography for 3 and for 30 minutes.
15962032|NCT03173183|Drug|genuine regional Rhizoma Atractylodis (Maozhu granule)|"Maozhu granule, 9g per bag, manufactured by Guangdong Yifang Pharmaceutical Co., Ltd.
~Luozhu granule, 9g per bag, manufactured by Guangdong Yifang Pharmaceutical Co., Ltd.
~Simulants (granule), 9g per bag, manufactured by Guangdong Yifang Pharmaceutical Group Co., Ltd."
15962033|NCT03173170|Drug|TAK-954|TAK-954 Infusion
15962034|NCT03173170|Drug|Itraconazole|Itraconazole Capsule
15962035|NCT03173157|Other|Value Feedback Email|a biweekly email to three house staff-run cardiology services at VUMC presenting the in-hospital charges and appropriate use of echocardiography. A weekly email will also be sent to the intervention services detailing their team's in-hospital charges for echocardiograms during the preceeding week.
15962036|NCT03173144|Other|Primary exposure variable|"Upper tertile (33.3% of the total sample) based on the ratio: fibre/meat intake is associated with better treatment outcome
~Low intake of red and processed meat (defined as below the lower tertile [33.3% of the total sample]) and high intake of dietary fibres (defined as those above the upper tertile [33.3% of the total sample]) are independently associated with better treatment outcome, and their synergy (interaction between the factors meat and fibres) gives the best treatment outcome"
15962037|NCT03173144|Other|Other (exploratory) exposure variables|"Lifestyle factors independently or combined (red and processed meat, vegetable, dietary fibre, cereals, gluten, legumes, red wine, dairy products, physical activity, smoking, total protein/ fat, protein/ fat from red and processed meat, glucemic index)
~Pretreatment lifestyle-associated biomarkers
~Combinations of lifestyle factors and lifestyle-associated biomarkers
~Gene-environment interaction analyses
~Pretreatment levels of inflammatory molecules"
15962038|NCT03173131|Behavioral|Pre-operative opioid counseling|Patients will be randomized to receive counseling regarding opioid medication and post operative pain control.
15962039|NCT03173118|Procedure|Endoscopic ultrasound elastography|Endoscopic ultrasound elastography performed on both groups of patients as per routine
15962040|NCT03173105|Device|active tDCS|TDCS will be administered using with two sponge (non-metallic) surface electrodes (5 x 7 cm2) moistened with saline solution. For stimulation of the motor motor, somatosensory, and visual cortices with a current of 2mA for 20 minutes. The cathode will be positioned in the medial supraorbital region.
15962041|NCT03173105|Device|sham tDCS|Sham TDCS will be administered using with two sponge (non-metallic) surface electrodes (5 x 7 cm2) moistened with saline solution The stimulator will only be switched on for the first 30 seconds, giving the participant the initial sensation of tDCS, but no active stimulation throughout the remainder of the session the proprioceptive exercise session
15962042|NCT03173105|Other|Dynamic proprioceptive exercises|The dynamic proprioceptive exercises will be conducted as follows: 1) walking slowly then more quickly on a trampoline; 2) walking backward with one foot behind the other; 3) walking forward on a beam; 4) going up and down a flight of stairs; and 5) sitting on a Swiss exercise ball (65 cm) and performing laterolateral, anteroposterior, circling movements and bouncing. Activities will be performed in three one-minute sets.
15962043|NCT03173105|Other|static proprioceptive exercises|The static exercises will be conducted as follows: 1) standing on toes with feet apart; and 2) with feet together; 3) standing on only right leg without support; and 4) on only left leg without support; and 5) standing with heel of right (or left) foot touching toes of left (or right) foot with feet in a straight line over on an unstable surface (wobble board) performed in six sets of 30 seconds each, with a one-minute rest interval between sets
15962044|NCT03173092|Drug|Ixazomib|Ixazomib capsules.
15962045|NCT03173092|Drug|Lenalidomide|Lenalidomide capsules.
15962046|NCT03173092|Drug|Dexamethasone|Dexamethasone.
15962047|NCT03173079|Other|pre- and postinterventional geriatric assessment in patients undergoing TAVI|geriatric assessment
15962048|NCT03173066|Drug|Ferumoxytol|ferumoxytol-enhanced magnetic resonance angiography for the diagnosis of pulmonary embolus
15962049|NCT03173053|Drug|Doxycycline|tablet
15962050|NCT03173053|Drug|Trimethoprim|tablet
15962051|NCT03173053|Drug|Sulfamethoxazole/trimethoprim|tablet
15962052|NCT03173053|Drug|Clindamycin|tablet
15962053|NCT03173053|Drug|Clarithromycin|tablet
15962054|NCT03173053|Drug|Ciprofloxacin|tablet
15962055|NCT03173053|Drug|Fusidic Acid|tablet or ointment
15962056|NCT03173053|Drug|Rifampin|tablet
15962057|NCT03173053|Drug|Chlorhexidine|Mouthwash or bodywash
15962058|NCT03173053|Drug|Mupirocin|Nasal ointment
15962059|NCT03173053|Drug|Betadine|Shampoo
15962060|NCT03173040|Drug|NiuBangZi pill or NiuBangZi pill placebo|For the treatment group (NiuBangZi pill group), patients will be instructed to dissolve NiuBangZi pill (4 g) in 200 mL hot water and take the solution orally twice a day for 3 months. While patients in the placebo group will take NiuBangZi pill placebo as the same way. Besides that, both groups will also administrate MTX (5 mg per week) in addition, and glucocorticoid (less than 5mg a day) if necessary, but any other drugs especially herbs not permit.
15962061|NCT03173027|Drug|Fangji Huangqi pill or Fangji Huangqi pill placebo|For the treatment group (Fangji Huangqi pill group), patients will administrate Fangji Huangqi pill (4 g) in 200 milliliter hot water as the instruction and take the solution orally twice a day for 1 month. While patients in the placebo group will take Fangji Huangqi pill placebo as the same way as the Fangji Huangqi pill group. Besides that, both groups will administrate Mobic (7.5 mg once a day) in addition.
15962062|NCT03173014|Device|EEG|EEG monitoring
15962063|NCT03173001|Diagnostic Test|Parasitological examination|Three stool samples for parasitological examination will be taken from control subjects and CRC patients at 1-2 days interval.
15962153|NCT03172351|Device|EDoF2|Comparison EDoF2 IOL
15962066|NCT03172988|Drug|Flurbiprofen axetil|Flurbiprofen axetil 50 mg is administered before the start of surgery. Postoperative analgesia is provided with a patient-controlled analgesia pump, which is established with 100 ml of 1.25 μg/ml sufentanil and 2 mg/ml flurbiprofen axetil, programmed to deliver a 2 ml bolus with a lockout interval of 6-8 min and a background infusion of 1 ml/h.
15962067|NCT03172988|Drug|Lipid microsphere|Lipid microsphere 5 ml is administered before the start of surgery. Postoperative analgesia is provided with a patient-controlled analgesia pump, which is established with 100 ml of 1.25 μg/ml sufentanil and 20 ml lipid microsphere, programmed to deliver a 2 ml bolus with a lockout interval of 6-8 min and a background infusion of 1 ml/h.
15962068|NCT03172975|Biological|Na-GST-1/Alhydrogel|Recombinant ˆNecator americanusˆ Glutathione-S Transferase adjuvanted with Alhydrogel
15962069|NCT03172975|Biological|Na-GST-1/Alhydrogel + CPG 10104|Recombinant ˆNecator americanusˆ Glutathione-S Transferase adjuvanted with Alhydrogel and co-administered with CPG 10104, a synthetic oligodeoxynucleotide
15962070|NCT03172975|Biological|Na-GST-1/Alhydrogel + GLA-AF|Recombinant ˆNecator americanusˆ Glutathione-S Transferase adjuvanted with Alhydrogel and co-administered with an aqueous formulation of Glucopyranosyl-Lipid A (GLA-AF)
15962071|NCT03172975|Biological|Placebo|Physiological sterile saline solution
15962072|NCT03172975|Drug|Albendazole|Treatment with 3 daily oral doses of 400 mg albendazole at end of study.
15962073|NCT03172975|Other|Necator americanus Larval Inoculum|50 infectious Necator americanus larvae applied via dermal application (challenge infection).
15962074|NCT03172962|Behavioral|Strength training|Specific strength training exercises for the lumbar and abdominal muscles for 8 weeks
15962075|NCT03172962|Behavioral|Usual care (control)|Will receive the usual care at the hospital
15962076|NCT03172936|Drug|MIW815|MIW 815 (ADU-S100) is a STING agonist
15962077|NCT03172936|Biological|PDR001|PDR001 is an anti-PD-1 antibody
15962078|NCT03172923|Device|sliding hip screw|fixation of the fracture with a sliding hip screw
15962079|NCT03172923|Device|intramedullary nial|fixation of the fracture with an intramedullary nail
15962080|NCT03172910|Drug|Ciraparantag|Ciraparantag (administered over 10 minutes)
15962081|NCT03172910|Drug|Placebo|Saline for injection
15962082|NCT03172910|Drug|Rivaroxaban|Rivaroxaban 20 mg given once per day (QD) in the morning
15962083|NCT03172897|Drug|Dexmedetomidine|Dexmedetomidine is administered as a continuous intravenous infusion at a rate of 0.025 mL/kg per h (0.1 μg/kg per h) from study recruitment in the ICU for no more than 72 hours.
15962084|NCT03172897|Drug|Placebo (normal saline)|Placebo (normal saline) is administered as a continuous intravenous infusion at a rate of 0.025 mL/kg per h from study recruitment in the ICU for no more than 72 hours.
15962085|NCT03172884|Drug|Copanlisib (ALIQOPA, BAY80-6946)|12mg single dose, intravenous on Day 0
15962086|NCT03172871|Drug|Aripiprazole IM Depot|Aripiprazole IM depot 400 mg/300 mg (when not tolerated)
15962087|NCT03172871|Drug|Aripiprazole tablet|Oral aripiprazole tablets 10 to 20 mg daily
15962088|NCT03172858|Device|Intracervical balloon catheter|cervical ripening balloon
15962089|NCT03172858|Drug|Oxytocin|medication used to induce contractions
15962090|NCT03172845|Procedure|percutaneous coronary intervention|percutaneous coronary intervention with drug-eluting stent implantation.
15962091|NCT03172832|Procedure|PTBD|Percutaneous access and tube placement into the bile duct
15962092|NCT03172832|Procedure|ERC|Endoscopic access and stent placement in the bile duct
15962093|NCT03172819|Biological|OBP-301|"Intratumoral injection directly into the dose target region of a tumor at Day 1, Day 15, and Day 29.
~Additional administration of OBP-301 After the recommended dose of OBP-301 has been established, additional administration of OBP-301 is allowed. After completion of administration of OBP-301 on Day 1 - Day 29(+/- 4 days), if the target region has not disappeared, additional administration of OBP-301 is allowed after Day 43 or later.
~The patients in Phase 1a, Pembrolizumab administration has continued, are included.
~The recommended dose determined in the Phase 1a part will be administered 3 times biweekly (+/- 4 days); max 4 cycles."
15962094|NCT03172819|Drug|Pembrolizumab|200 mg Pembrolizumab is infused intravenously at Day 8. Thereafter infusion will continue every 3 weeks until discontinuation.
15962095|NCT03172806|Diagnostic Test|Polysomnography|To compare the ability of the clinical scores, all patients included in this study underwent a polysomnography.
15962096|NCT03172793|Drug|Telavancin Injection|Receive 3 doses of telavancin as described in arm/groups, followed by collection of blood for pharmacokinetic analyses.
15962097|NCT03172780|Drug|Diclofenac sodium gel 1%|Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
15962098|NCT03172780|Drug|Voltaren® Gel (Diclofenac Sodium Topical Gel) 1%|Diclofenac Sodium Topical Gel, 1%. 4 gm, 4 times a day for 4 weeks
15962099|NCT03172780|Drug|Placebo gel|Vehicle Gel 4 gm, 4 times a day for 4 weeks
15962100|NCT03172754|Drug|Nivolumab|PD-1 inhibitor
15962101|NCT03172754|Drug|Axitinib|Tyrosine kinase inhibitor
15962102|NCT03172741|Drug|Medical Marijuana|1-gram marijuana cigarette smoked once per day for 3 months
15962103|NCT03172741|Drug|Placebo|Matching 1 gram placebo cigarette smoked once per day for 3 months
15962104|NCT03172728|Behavioral|psycho-education pamphlet|psycho-education intervention, based on Cognitive Behavioral Therapy, that is easy to provide and feasible in standard perinatal care. It is intended to increase awareness of obsessive thoughts and to decrease anxiety and encourage treatment seeking.
15962105|NCT03172715|Procedure|Locking plate|Osteosynthesis
15962106|NCT03172715|Procedure|TKR|Total knee arthroplasty
15962107|NCT03172702|Drug|Zirconium Cyclosilicate|Correction Phase Dosing: Sodium Zirconium Cyclosilicate 10 g three times daily (TID) from 24 to 72 Extended Dosing: Sodium Zirconium Cyclosilicate 5 g once daily (QD). Sodium Zirconium Cyclosilicate dose increased or decreased in increments/decrements of 5 g QD up to a maximum of 15 g QD or a minimum of 5 g every other day (QOD) (or 2.5 g QD) based on i-STAT potassium measurements up to 12 months.
15962108|NCT03172689|Device|CardioQ|comparison of cardiac output measurements between gold standard transpulmonary thermodilution (by PiCCO) versus an oesophageal doppler monitor (CardioQ) They will be used simultaneously
15962109|NCT03172676|Drug|Amoxicillin 50 mg/kg/day in 2 divided doses for 14 days.|chronic immune thrombocytopenic purpura patients who will be diagnosed positive for helicobacter pylori infection will receive Amoxicillin for 14 days.
15962110|NCT03172676|Drug|Clarithromycin 15 mg/kg/day in 2 divided doses for 14 days.|chronic immune thrombocytopenic purpura patients who will be diagnosed positive for helicobacter pylori infection will receive Clarithromycin for 14 days.
15962111|NCT03172676|Drug|Proton pump inhibitor 1 mg/kg/day in 2 divided doses 1 month|chronic immune thrombocytopenic purpura patients who will be diagnosed positive for helicobacter pylori infection will receive proton pump inhibitor for 1 month.
15962112|NCT03172663|Device|pure tone audiometry|for estimate the type and degree of hearing loss
15962113|NCT03172650|Diagnostic Test|glomerular filtration rate|collection of blood sample 5 milliliter for calculation of glomerular filtration rate
15962114|NCT03172624|Drug|Nivolumab|nivolumab 3 mg/kg every 2 weeks
15962115|NCT03172624|Drug|Ipilimumab|ipilimumab 1 mg/kg every 6 weeks (1 cycle= 6 weeks)
15962116|NCT03172611|Other|Dietary Intervention|Subjects consumed a defined, plant-based diet for 4-weeks. Emphasized were raw fruits and vegetables.
15962117|NCT03172598|Drug|MT-8554 low dose|Capsule
15962118|NCT03172598|Drug|MT-8554 middle dose|Capsule
15962119|NCT03172598|Drug|MT-8554 high dose|Capsule
15962120|NCT03172598|Drug|Placebo|Capsule
15962121|NCT03172585|Other|High resolution computed tomography|High resolution computed tomography of the chest is the gold standard imaging modality for most pulmonary diseases
15962122|NCT03172585|Other|trans thoracic ultrasonography|Trans thoracic ultrasonograghy is used progressively for evaluation of pulmonary diseases . Its non invasive nature , relatively low price ,portability for bedside use, and high reproducible of results allows for incorporation of imaging findings with clinical data
15962123|NCT03172572|Procedure|Minimally invasive pancreatoduodenectomy|Laparoscopic, robot-assisted, or hybrid resection
15962124|NCT03172572|Procedure|Open pancreatoduodenectomy|Open resection
15962125|NCT03172559|Radiation|Stereotactic body radiotherapy|The recommended dose will be 30 Gy in 5 fractions. The treatment will be administered in 5 alternative days and will be individualized with the dose based on baseline liver function, effective liver volume irradiated and proximity to other normal tissues.
15962126|NCT03172546|Genetic|PK-PD genetic polymorphisms|PK-PD genetic polymorphisms analysis in patients receiving either anti-IIa or anti-Xa treatment
15962127|NCT03172533|Drug|ethinyl estradiol 0.03mg and dienogest 2 mg (combination)|approved oral contraceptive (Germany): Maxim
15962128|NCT03172533|Drug|Placebo oral capsule|placebo
15962129|NCT03172520|Device|APS electrode|The APS electrode is an accessory intended for providing automatic periodic stimulation to nerves when used with the Medtronic Nerve Monitoring Systems.
15962130|NCT03172520|Device|Facial Nerve Monitor|The facial nerve monitoring system records the number of stimulations of the facial nerve during the operation and this data is stored on the device until it is shut down after the surgery is complete.
15962131|NCT03172494|Drug|Insulin degludec/liraglutide|"Subcutaneously (s.c., under the skin)administration once daily in combination with metformin.
~For 26 weeks."
15962132|NCT03172494|Drug|Insulin degludec|"Subcutaneously (s.c., under the skin)administration once daily in combination with metformin.
~For 26 weeks."
15962133|NCT03172494|Drug|Liraglutide|"Subcutaneously (s.c., under the skin)administration once daily in combination with metformin.
~For 26 weeks."
15962134|NCT03172481|Drug|PRC-063 oral capsules|Daily dose
15962135|NCT03172481|Drug|Placebo oral capsules|Daily dose
15962136|NCT03172455|Drug|Glassia|Application 90 mg/kg loading dose day 1, 30 mg/kg every other day (day 3 - day 15)
15962137|NCT03172442|Device|Vacuum plate|Vacuum plate with two hooks between lateral incisor and canine in each side will be applied on the lower arch.
15962138|NCT03172442|Device|Rapid maxillary expander|Rapid maxillary expander will be applied in the maxilla to disarticulate maxillary sutures to allow more efficient forward protraction of the maxilla.
15962139|NCT03172442|Device|Class III elastics|Class III elastic traction from upper first molar to the hook in both side will be applied.
15962140|NCT03172416|Drug|Oxaliplatin|This study started as a prospective, single arm phase I trial in a 3 + 3 dose escalation evaluating the safety and tolerability of PIPAC using oxaliplatin in patients with peritoneal carcinomatosis.
15962141|NCT03172416|Drug|Oxaliplatin & Nivolumab|PIPAC oxaliplatin 90mg/m2 has been well tolerated in our Cohort 1 study. Hence, we added a second cohort (Cohort 2) which combines PIPAC oxaliplatin at 90mg/m2 every 6 weeks with IV nivolumab at 240mg every 2 weeks to evaluate the safety and tolerability of combination therapy.
15962142|NCT03172403|Diagnostic Test|Height and weight|Height and weight will be measured to estimate cachexia degree at the time of anaesthetic consultation. (V1)
15962143|NCT03172403|Diagnostic Test|Blood samples|Blood samples will be collected for measuring myostatin on blood at the time of anaesthetic consultation, the day before resection surgery, follow-ups at 1, 3 and 6 months. (V1, V2, V3, V4, V6)
15962144|NCT03172403|Diagnostic Test|Skeletal muscle force|Skeletal muscle force will be determined from Computerized Tomography (CT)-scan at the time of anaesthetic, follow-ups at 1, 3 and 6 months. (V1, V3, V4, V6)
15962145|NCT03172403|Diagnostic Test|Skeletal muscle index|Skeletal muscle index will be determined from Computerized Tomography (CT)-scan at the time of anaesthetic, follow-ups at 1, 3 and 6 months. (V1, V3, V4, V6)
15962146|NCT03172403|Diagnostic Test|Muscle biopsy|Muscle biopsy will be performed during resection surgery under general anaesthesia. (V2)
15962147|NCT03172390|Device|4D Cardiac Magnetic Resonance|4D Cardiac Magnetic Resonance for patients with a ascending aorta dilatation without current indication for surgery for measured parameters of ascending aorta
15962148|NCT03172377|Other|Lengthening adalimumab dosing interval|Lengthening adalimumab dosing interval from 2 weeks to 3 weeks and -later- to 4 weeks.
15962149|NCT03172364|Other|Micellar cleanser|Participants will apply the micellar cleanser topically twice a day (morning and evening). Micellar cleanser will be applied on cotton pad and wiped over the entire face and closed eye to gently cleanse. No need to rub or rinse the micellar cleanser.
15962150|NCT03172364|Other|Micellar foaming cleanser|Participants will use the micellar foaming cleanser topically twice a day (morning and evening). Micellar foaming cleanser will be massaged gently onto wet skin on the face using fingertips. After which participants will rinse thoroughly and pat the skin dry.
15962151|NCT03172351|Device|EDoF1|extended depth of focus IOL - EDoF1
15962152|NCT03172351|Device|Monofocal|Monofocal IOL
15962158|NCT03172312|Procedure|Different range of thyroid surgery|Observe and record parathyroid status during thyroid surgery
15962159|NCT03172299|Drug|Aflibercept Injection|Intravitreal injection of aflibercept 40mg/mL will be done on patients. The injections will be performed on the last day of the proton therapy, then 1 and 2 months later for the induction phase. During the maintenance phase, injections will be performed every 3 months for a period of 21 months.
15962160|NCT03172299|Drug|False injection|A false injection will be done on patients on the last day of the proton therapy, then 1 and 2 months later for the induction phase. During the maintenance phase, falses injections will be performed every 3 months for a period of 21 months.
15962161|NCT03172286|Device|Radiofrequencer|Patients will be treated with a radiofrenquencer switched on or off depending on the attributed group after randomization
15962162|NCT03172273|Procedure|TIPS|Transjugular intrahepatic portosystemic shunt with covered PTFE
15962163|NCT03172273|Procedure|paracentesis|paracentasis plus albumine invision
15962164|NCT03172260|Device|E Balance Pro Therapy|Micro-current treatment
15962165|NCT03172234|Other|oral amantadine sulfate|In amantadine group:the patients will receive100 mg oral amantadine sulfate 90 minute prior to the surgery
15962166|NCT03172234|Drug|oral gabapentin|In gabapentin group: the patients will receive oral 800 mg gabapentin 90 minute prior to the surgery
15962167|NCT03172234|Drug|Placebo Oral Tablet|in control group : the patients will receive Placebo Oral Tablet 90 minute prior to the surgery
15962168|NCT03172221|Diagnostic Test|HS-RDT|A single finger-prick blood sample will be collected and used to test participants with the HS-RDT. The results of the results of the test will not be used for treatment purposes nor used to inform patient care.
15962169|NCT03172208|Biological|Caplacizumab Dose 1 iv (single-dose)|Single intravenous (iv) administration of Caplacizumab Dose 1
15962170|NCT03172208|Biological|Caplacizumab Dose 2 iv (single-dose)|Single intravenous (iv) administration of Caplacizumab Dose 2
15962171|NCT03172208|Biological|Caplacizumab Dose 2 sc (single-dose)|Single subcutaneous (sc) administration of Caplacizumab Dose 2
15962172|NCT03172208|Biological|Caplacizumab Dose 2 sc (multiple-dose)|Once daily subcutaneous (sc) administration of Caplacizumab Dose 2 during 7 consecutive days
15962173|NCT03172208|Other|Placebo iv (single-dose)|Single intravenous (iv) administration of Placebo
15962174|NCT03172208|Other|Placebo sc (single-dose)|Single subcutaneous (sc) administration of Placebo
15962175|NCT03172208|Other|Placebo sc (multiple-dose)|Once daily subcutaneous (sc) administration of Placebo during 7 consecutive days
15962176|NCT03172195|Procedure|rectosigmoidoscopy|A rectosigmoidoscopy will be realized and two fragments will be collected.
15962177|NCT03172195|Biological|biopsies|For this study, two biopsies in healthy area and two biopsies in ulcer will be collected.
15962178|NCT03172195|Biological|blood sample|Blood sample will be collected in more.
15962179|NCT03172182|Behavioral|a 360-degree VR video tour|At operation day, pediatric patients of the VR group and their parents are educated using virtual tour program explaining preoperative procedures and showing environment of the operating room. A 360-degree virtual reality (VR) video for the tour program was filmed in advance and is provided using a head mount device into which a smartphone is installed, at 30 minutes before the induction of anesthesia.
15962180|NCT03172169|Other|no Intervention|no Intervention
15962181|NCT03172156|Genetic|ctDNA detection|To detect ctDNA in Patients With Stage I Non-small Cell Lung Cancer (NSCLC) Using Secondary Gene Sequencing (NGS)
15962182|NCT03172143|Procedure|Mesenteric Sparing Ileocolic Resection|In this resection, the mesentery will be spared, or left in situ during resection.
15962183|NCT03172143|Procedure|High Ligation Ileocolic Resection|"In this resection, a high ligation is performed, where the feeding vessel is taken at its origin in order to take sufficient mesentery and lymph nodes with the colon specimen."
15962184|NCT03172130|Device|Straight CPAP|
15962185|NCT03172130|Device|Sham CPAP|
15962186|NCT03172117|Biological|human umbilical cord blood derived mesenchymal stem cells|"Low dose: 1 x 10^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4 week intervals
~High dose: 3 x 10^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4 week intervals"
15962187|NCT03172117|Other|Normal saline 2mL|Normal Saline at 4 week intervals via an Ommaya Reservoir, for a total of 3 administrations
15962188|NCT03172091|Device|eNose (electronic nose)|Collection of exhaled breath for an immediate analysis by electronic nose
15962189|NCT03172091|Device|Spectrometry|Collection of exhaled breath for an immediate analysis by mass spectrometry
15962190|NCT03172078|Procedure|advanced endoscopic procedure|The advanced endoscopic procedure include endoscopic Ultrasound (EUS), endoscopic retrograde cholangiopancreatogram (ERCP), and other upper gastrointestinal endoscopy.
15962191|NCT03172065|Drug|Normal saline|intravenous flluid
15962192|NCT03172065|Drug|Dexmedetomidine|anaesthetic adjuvants and pain killer medication.
15962193|NCT03172052|Drug|streptokinase|• Chemical adhesiolysis by instillation of streptokinase at a dose of 250,000 I.U dissolved in 40 ml of normal saline will be instil in the pleural cavity through the chest tube. we planning to continue the daily instillation as long as the drained fluid volume is >100 cc with a maximum of 14 doses and to stop further instillation if severe complication occurred.
15962194|NCT03172052|Drug|MESNA (2-mercaptoethane sulfonate Na)|• Chemical adhesiolysis by instillation of MESNA at a dose of 1800 mg of MESNA i.e. 3 ampoules ( each ampoule contains 3ml and each ml contains 200 mg of MESNA) will be diluted with 20ml of Normal Saline and will be injected into the pleural cavity through the chest tube for three consecutive days.
15962195|NCT03172052|Device|Medical thoracoscopy|Medical thoracoscopy procedure will be carried at endoscopy unit at chest department via, semi rigid thoracoscope (LTF; Olympus; Tokyo, Japan).
15962196|NCT03172052|Device|Video assisted thoracoscopy (VATS)|Video assisted thoracoscopy (VATS) at cardiothoracic surgery department.
15962197|NCT03172026|Drug|Maraviroc 300 mg|FDA approved chemokine receptor (CCR5) inhibitor. Maraviroc will be started within two weeks of discharge from inpatient rehabilitation, which most often will occur from 4-6 weeks after stroke onset.
15962237|NCT03171753|Diagnostic Test|laboratory test|laboratory test will be collected before the application of headphone and after their removal. the cardiac monitoring will be performed during the all study period
15962198|NCT03172026|Behavioral|Rehabilitation therapy|"All participants will have routine outpatient or home health physical and occupational therapy after inpatient discharge as prescribed by their physicians.
~Each group will be contacted weekly by phone to help maintain interest in the trial, count the number of usual care physical and occupational therapy completed, assure use of the assigned medication, ask about possible adverse reactions, and to encourage them to be active. The coordinator will obtain this information and provide the feedback using a standard script and checklist. A unique aspect of this trial is a telerehabilitation component that aims to give feedback to all participants to practice with the affected arm and walk daily."
15962199|NCT03172026|Drug|Placebo 300 mg|Matched placebo will be started within two weeks of discharge from inpatient rehabilitation, which most often will occur from 4-6 weeks after stroke onset.
15962200|NCT03172013|Diagnostic Test|Platelet indices|MPV, PDW
15962201|NCT03172000|Diagnostic Test|Colonoscopy and biopsy|Colonoscopic biopsy were taken from the rectum, the sigmoid, descending, transverse, ascending colon, and the cecum of each patient.
15962202|NCT03171987|Drug|Lidocaine patch local application|Attach the patch to back pain area 1 piece per day with no more than 6 hours.
15962203|NCT03171987|Drug|Flurbiprofen patch local application|Attach the patch to back pain area 1 piece per day with no more than 6 hours.
15962204|NCT03171974|Drug|Dexamethasone|dexamethasone will be injected intracapsular under US
15962205|NCT03171974|Device|US|dexamethasone will be injected intracapsular under US
15962206|NCT03171961|Behavioral|online visit group|subjects has online visit with dietitian every 2 weeks+diet
15962207|NCT03171961|Behavioral|Clinic visit group|Clinic visit group ,subjects has every 2 weeks in person visit at clinic+diet
15962208|NCT03171961|Behavioral|self-directed group|self-directed group receives nutritional information via web and their energy needs for weight loss
15962209|NCT03171948|Behavioral|Almond Group|Almond Group (AG) are asked to have a 30 gr. almond every day in their afternoon snack plus following the hypoenergetic diet
15962210|NCT03171948|Behavioral|Nut Free group|continue their diet without any nut consumption.
15962211|NCT03171935|Device|High-Flow Nasal Cannula Oxygenation|High-flow nasal cannula oxygenation will be applied immediately after early extubation, with a gas flow rate of 50 liters per minute and a fraction of inspired oxygen of 1.0 at initiation. The fraction of inspired oxygen will be subsequently adjusted to maintain a peripheral oxygen saturation of 92% or more.
15962212|NCT03171935|Device|Noninvasive Positive Pressure Ventilation|Noninvasive positive pressure ventilation will be applied immediately after early extubation, with a noninvasive ventilator (Respironics V60, Philips) using the NIPSV mode at initiation. The fraction of inspired oxygen will be adjusted to achieve SpO2 >92% with an initial expiratory positive airway pressure (EPAP) of 4 cmH2O. EPAP will be increased gradually in increments of 1-2 cmH2O, up to a maximum of 12 cmH2O, to achieve SpO2 >96%. Inspiratory positive airway pressure (IPAP) will be initially set at 8 cmH2O and be increased gradually in increments of 1-2 cmH2O according to patients' tolerance to obtain a tidal volume (VT) of 6-8 mL/kg.
15962213|NCT03171935|Device|Conventional weaning|The patients will undergo conventional weaning protocol. Extubation and subsequent oxygen therapy with venturi mask will be performed after successful spontaneous trial.
15962214|NCT03171922|Behavioral|Internet Diet|ID group have online dietary coach every 2 weeks
15962215|NCT03171922|Behavioral|Clinic Diet|CD group have every 2 weeks visit at clinic
15962216|NCT03171896|Other|clown|A medical clown will be offerred to the parturient and will spend time with her during labor as long as she will want it
15962217|NCT03171896|Other|Sham|No clown will be present in the room during labor
15962218|NCT03171870|Diagnostic Test|high resolution computed tomography|high resolution computed tomography is an essential component of the diagnostic pathway in idiopathic pulmonary fibrosis. Unusual interstitial pneumonia is characterized on high resolution computed tomography by the presence of reticular opacities, often associated with traction bronchiectasis
15962219|NCT03171844|Other|Skin to skin|3 sessions of skin to skin will be made on newborn wearing an umbilical venous catheter
15962220|NCT03171831|Drug|Busulfan|Busulfan（4 mg/kg/day,4 days）
15962221|NCT03171831|Drug|Cyclophosphamide|Cyclophosphamide（50 mg/kg/day,4 days）
15962222|NCT03171831|Drug|Fludarabine|Fludarabine（50 mg/m2/day,3 days）
15962223|NCT03171831|Drug|Mycophenolate mofetil|Mycophenolate mofetil（0.25g/day）
15962224|NCT03171831|Drug|Tacrolimus|Tacrolimus（0.03mg/kg/day）
15962225|NCT03171831|Drug|Methotrexate|Methotrexate（15mg/m2 on day +1,10mg/m2 on day +3,+6,+11）
15962226|NCT03171831|Drug|Thymoglobulin|Thymoglobulin（2.5 mg/kg/day,4 days）
15962227|NCT03171831|Drug|Basiliximab|Basiliximab（10mg on day 0 and +4）
15962228|NCT03171818|Drug|Darbepoetin Alfa|Darbepoetin alfa (Aranesp, Amgen) 2 doses of 10 microgram/kg i.v.
15962229|NCT03171818|Drug|Saline|The placebo will consist of saline, containing 9.0 g of salt per liter (0.90%) i.v.
15962230|NCT03171805|Drug|Propranolol|Propranolol was given after patients with cirrhosis and isolated gastric varices underwent balloon occluded retrograde transvenous obliteration successfully.
15962231|NCT03171792|Other|semi-structured interviews|Semi-structured face to face or telephone interviews with an open-ended approach. Duration: about 45 minutes. Audio-recorded. Exploration of the experience of taking care of the suffering adolescents.
15962232|NCT03171779|Other|Patients approaching the end of their lives|To determine whether the use of simple tools by a primary care team for the early identification of end-of-life patients can improve access to specialized palliative care resources
15962233|NCT03171766|Diagnostic Test|Mini-Mental State Examination (MMSE)|It is simple scored form of the cognitive mental status examination which includes eleven questions and requires only 5 to 10 minutes.
15962234|NCT03171766|Diagnostic Test|Visual Analog Scale (VAS)|Visual Analog Scale (VAS) for pain score (including aphasia, motor disability, major neurocognitive disorder, etc)
15962235|NCT03171766|Diagnostic Test|Mini Cog test|The Mini-Cog© test is another validated and simple tool to screen for dementia and cognitive dysfunction. It measures the cognitive reserve at the time of acute stress with a low degree of interobserver variability.
15962236|NCT03171753|Diagnostic Test|questionnaire|questionnarie will be performed before the application of headphone and after their removal.
15962238|NCT03171753|Diagnostic Test|cardiac monitoring|the cardiac monitoring will be performed through study period
15962239|NCT03171753|Diagnostic Test|skin resistance|the skin resistance monitoring will be performed through study period
15962240|NCT03171753|Device|Music listening|Listening prerecorded music through an individual headset for 30 min
15962241|NCT03171753|Device|No sound|No sound through an individual headset for 30 min
15962242|NCT03171740|Drug|Dexmedetomidine|Intranasal dexmedetomidine, 1mcg/kg (it is a 100mcg/ml solution)
15962243|NCT03171740|Drug|Midazolam oral solution|Oral midazolam, 0.5mg/kg (its a 2mg/ml solution)
15962244|NCT03171740|Drug|Oral saline|Oral saline, 0.25ml/kg
15962245|NCT03171740|Drug|Nasal saline|Nasal saline 0.01ml/kg
15962246|NCT03171727|Drug|low molecular weight heparin|After TIPS procedure was performed, low molecular weight heparin was given for three days.
15962247|NCT03171714|Device|Derma-Stent|The novel device will facilitate self removal by patients, as it has a narrower profile, and, as a nonabsorbent material, will not become saturated with bodily fluids. Although it will not absorb body fluids
15962248|NCT03171714|Device|Usual care, cotton gauze packing|Standard gauze packing used to pack a drained abscess.
15962249|NCT03171662|Other|Evaluation of Pediatric Appendicitis Score|Imaging and Histopathological examination for Evaluation of Pediatric Appendicitis Score
15962250|NCT03171649|Device|RETRAINER-S1|"It consists of the execution of different exercises with the affected arm supported by the RETRAINER-S1 device. The subject is actively involved in the exercises and the system provides two types of support: weight relief and FES. The following exercises can be performed:
~anterior reaching (in a plane or in the space)
~lateral elevation of the arm
~hand to mouth movements with or without an object in the hand
~moving objects on a plane or in the space. A subset of exercises is defined based on the patient's capability and the training time is equally shared between the selected exercises. The different training sessions can include different exercises and a different number of repetition for each exercise."
15962251|NCT03171649|Other|Conventional therapy|"It consists of a combination of different treatment modalities among the following, based on the petient's specific needs:
~Upper limb passive motion
~Arm Cycle ergometer with or without FES
~Neuro Muscular Electrical Stimulation
~Upper limb exercises using augmented or virtual reality environment
~Occupational therapy exercises
~Constraint induced movement therapy
~Upper limb active movement (reaching, grasping, elevation, spatial orientation)
~Repetitive task training
~Mirror therapy
~Writing training
~Chemodenervation Therapy"
15962252|NCT03171623|Drug|globalagliatin hydrochloride|orally administration, single dose
15962253|NCT03171623|Drug|placebo|orally administration, single dose
15962254|NCT03171610|Drug|Sufentanil group|PCA device containing sufentanil (3 mcg/kg), ramosetron (NaseaTM) 0.3 mg and ketorolac 120 mg in a normal saline with a total volume of 100ml was connected.
15962255|NCT03171610|Drug|Fentanyl group|PCA device containing fentanyl (20 mcg/kg), ramosetron (NaseaTM) 0.3 mg and ketorolac 120 mg in a normal saline with a total volume of 100ml was connected.
15962256|NCT03171597|Drug|Anti-Platelet Drugs|Including aspirin and clopidogrel, etc.
15962257|NCT03171597|Drug|Lipid Regulating Drugs|Mainly including statins
15962258|NCT03171597|Drug|Coronary Vasodilator|Mainly including nitrates
15962259|NCT03171597|Drug|Xuefu Zhuyu Decoction|Mainly including Peach Kernel, Safflower, Angelica, Bupleurum etc.
15962260|NCT03171597|Drug|Gualou Xiebai Banxia Decoction & Danshen Decoction|Mainly including Fructus Trichosanthis, Rhizoma Pinelliae, Allium, Salvia Miltiorrhiza etc.
15962261|NCT03171597|Drug|Shuanghe Decoction|Mainly including Ginseng, Poria, Calamus, Cyperus, Salvia miltiorrhiza, Radix Polygalae etc.
15962262|NCT03171584|Drug|Terbinafine|oral antifungal drugs
15962263|NCT03171571|Other|Coaching procedure|"In this study, the volunteers will be followed during one year. The wellbeing will be followed with :
~survey like FFQ, SF36, dietary habits.
~actimetry measurement
~one year follow-up of weight, waist measurement
~nutritional biomarkers"
15962264|NCT03171558|Procedure|Gastric Pull Up|Using gastric tissue to reconstruct the esophagus and pharynx after pharyngo-esophagectomy.
15962265|NCT03171558|Procedure|Free Flap Surgery|Using radial forearm free flap or anterolateral thigh free flap to reconstruct the cervical esophagus and pharynx after pharyngectomy and cervical esophagectomy.
15962266|NCT03171545|Behavioral|Patient Activation|Patients in clinics assigned to this group will be offered peer mentoring and digital resources.
15962267|NCT03171545|Behavioral|Provider Education|Staff in clinics assigned to this group will receive team training and a checklist.
15962268|NCT03171532|Procedure|Strands of Hamstring Autograft in ACL reconstruction|The femoral and tibial ends will be tubularised and the final graft diameter will be recorded after passing through sizing cylinders graduated in 0.5mm increments. The femoral and tibial tunnels will be drilled as per standard technique for single bundle ACL reconstruction via trans-portal or trans-tibial route and both ends fixed by interference screw with additional post on the tibial end.
15962269|NCT03171519|Behavioral|Exercise|The EXERCISE group will participate in an aerobic exercise program for 12 weeks, performed in intensity relative to 50% of reserve heart rate, on a treadmill.
15962270|NCT03171519|Behavioral|Acupuncture|The ACUPUNCTURE group will participate in an aerobic exercise program following the protocol of the EXERCISE group, plus acupuncture therapy once a week.
15962271|NCT03171506|Other|Ketogenic diet|Participants in the usual care plus ketogenic diet group will receive usual care plus dietary counseling in accordance with a ketogenic diet such that ~5% energy comes from carbohydrate, 25% energy from protein, and 70% energy from fat for the duration of the 12 week study.
15962272|NCT03171506|Other|AND diet|Participants in the usual care plus AND diet group will receive usual care plus dietary counseling in accordance with the Academy of Nutrition and Dietetics guidelines in 2013 for the duration of the 12 week study.
15962273|NCT03171493|Biological|MV-NIS|Attenuated measles virus encoding NIS (MV-NIS)
15962274|NCT03171480|Drug|Monoket Pill|Intra-vaginal application of Monoket as a cervical ripening agent for pregnant women undergoing induction of labor
15962275|NCT03171467|Procedure|Salpingectomy|
15962276|NCT03171454|Procedure|Delayed Intrauterine Balloon therapy|D-IUB dilatation therapy group will be performed using a (size 12-14fr) Foley catheter and according to the methodology published in the literature. This will be prepared by cutting the catheter tip protruding beyond the balloon. Once the catheter has reached the fundus, 5mls of saline will be slowly instilled into the balloon under ultrasound guidance.
15962277|NCT03171454|Procedure|immediate Intrauterine Balloon therapy|At the conclusion of the surgery, in the immediate balloon group: a Foley-catheter will be immediately inserted into the uterine cavity and the balloon will be distended with 4-5mls of saline under ultrasound guidance and the balloon will stay in situ for 7 days.
15962278|NCT03171441|Diagnostic Test|nailfold videocapillaroscopy|non-invasive nailfold videocapillaroscopy
15962279|NCT03171441|Diagnostic Test|inflammatory biomarkers|blood sample collection to asses leptin and C-reactive protein
15962280|NCT03171428|Procedure|Hepatectomy|Surgery for liver tumors is the removal of a part of the liver affected by a tumor.
15962281|NCT03171415|Drug|RZL-012|Subject receive a single-time injection. Multiple injections of RZL-012 are administered at 8-36 sites (0.1mL per site) into the abdominal subcutaneous fat.
15962282|NCT03171415|Drug|Placebo|Subject receive a single-time injection. Multiple injections of the Placebo are administered at 8-36 sites (0.1mL per site) into the abdominal subcutaneous fat.
15962283|NCT03171402|Diagnostic Test|Astringency and bitterness perception|Participants will be involved in 1-4 experiments that test how they rate and differentiate between bitter and astringent flavored beverage samples
15962284|NCT03171389|Drug|Ponatinib 30 MG|Ponatinib: once-daily oral dose of 30mg. A cycle of treatment is defined as 28 days. Doses may be reduced to manage drug-related adverse events and may be re-escalated once events resolve.
15962285|NCT03171376|Procedure|Root canal treatment and coronal restoration|After primary root canal treatment, Glass Ionomer Cement (Ketac™ Molar, 3M ESPE) applied as intraorifice barrier 3mm inside canal from root canal orifice in first group, as 2mm base on floor of pulp chamber in second group and direct composite restoration in 3rd group without Intraorifice barrier or base.
15962286|NCT03171363|Behavioral|Gaze-contingent feedback|Participants will receive gaze-contingent feedback according to their viewing patterns
15962287|NCT03171350|Diagnostic Test|ellume.lab Group A Streptococcus Test|ellume.lab Group A Streptococcus Test is a rapid diagnostic test intended to be used as an aid in the diagnosis of Group A Streptococcus in symptomatic patients. The sample type used is a throat swab.
15962288|NCT03171337|Device|Acupuncture|Acupuncture at acupoints for CTTH according to TCM theory using stainless filiform needle.
15962289|NCT03171337|Device|Fu's Subcutaneous Needling (FSN)|Fu's subcutaneous needling at specific points for CTTH using soft casing needle.
15962290|NCT03171337|Device|Sham acupuncture|Sham acupuncture at non-acupoints using Steinberger placebo needles
15962291|NCT03171324|Drug|Iron Supplement|2 mg/kg/day elemental iron
15962292|NCT03171311|Procedure|Angiographic guided PCI|Angiographic guided PCI is percutaneous coronary intervention performed by standard angiographic guided techniques
15962293|NCT03171311|Procedure|OCT guided PCI|OCT guided PCI is percutaneous coronary intervention (PCI) guided by intra vascular optical coherence tomography (OCT) scans
15962294|NCT03171298|Procedure|Laparoscopic Assisted Transanal Total Mesorectal Excision|"Abdominal approach with laparoscopic mobilization of the left colon
~Laparoscopic isolation and transection of inferior mesenteric vessels .
~Transabdominal dissection of the upper rectum and mesorectam.
~Insertion of transanal platform and the creation of pneumorectum.
~Occlusion of rectum 2 cm distal to the rectal lesion via purse string.
~Transanal dissection of lower and mid mesorectam
~The specimen will be extracted transanally"
15962295|NCT03171285|Other|Less than 35 years old|Clinical and laboratory evaluations
15962296|NCT03171285|Other|Greater than or equal to 35 years|Clinical and laboratory evaluations
15962297|NCT03171272|Other|Inspiratory Muscle Training|"Experimental: IMT will include training of the inspiratory muscles five times per week over six weeks, divided into two fiftten-minute sessions of inspiratory training totaling 30 minutes of training. Thresholds regulated at 50% of the subjects' maximal inspiratory pressure values, the load being increased weekly. Associated with the IMT, subjects will participate in the rehabilitation program, when they will perform 7 sessions of physiotherapy per week, totaling 42 sessions, as well as 180 minutes per week of aerobic exercise, for six weeks.
~Sham Group: This group will underwent exactly the same protocol but the participants will receive the threshold devices with the minimum resistance of the spring, which will be also concealed. The control group will also participate in the rehabilitation program and undergo the same procedures, except for the load adjustments."
15962298|NCT03171259|Other|care as usual|The investigators will be following patients with critical limb ischemia and documenting the usual care that the participants receive.
15962299|NCT03171246|Dietary Supplement|Solid food-based intervention|Individually tailored energy content according to age/activity
15962300|NCT03171233|Other|Mobilization with movement|Participants Mobilization Group with Movement are positioned knee facing the physiotherapist, are not elastic passages above the participant's malleolus and are from the physiotherapist's pelvis. The therapist applies a posterolateral slip sustained to a tibia through the belt, leaning backward, while the talus and forefoot are secured with the space between the thumb and the second finger of the hand of both hands. The participant will be instructed to perform a slow dorsiflexion movement for their maximum amplitude.
15962301|NCT03171233|Other|Self mobilization with movement|In the Auto Mobilization with Movement group, participants will self-mobilize the ankle on top of a box (15 centimeters with a 10 ° incline), a non-elastic band will pass below the malleoli and the back of the band will be placed in the middle of the other Lower limb, thus mobilizing the talus in the posteroinferior direction, the participant should maintain the force in that direction while making the dorsiflexion movement in closed kinetic chain until returning to the initial position again. Using the same group protocol as the therapist will help.
15962302|NCT03171220|Biological|Neoantigen Reactive T Cells(NRTs)|Neoantigen Reactive T Cells in an expected volume of 100 milliliter（mL） will be given by intravenous injection over 2-10 minutes through either a peripheral or a central line.
15962303|NCT03171220|Biological|SHR-1210|SHR-1210 200mg will be administered as an intravenous infusion over 60 minutes.
15962304|NCT03171220|Drug|Fludarabine|Fludarabine(FLU) 30mg/m2/d×3d，3 days prior to each NRTs infusion as preconditional chemotherapy.
15962305|NCT03171220|Drug|Cyclophosphamide|Cyclophosphamide(CTX) 300mg/m2/d×3d，3 days prior to each NRTs infusion as preconditional chemotherapy.
15962306|NCT03171220|Biological|Interleukin-2|Interleukin-2(IL-2)will be continuous intravenous infused since the first day of the cell infusion for 5 consecutive days, 4000,000 international unit per day.
15962870|NCT03167411|Drug|Exenatide Injection|Byetta® (Exenatide), 10 ug, bid, subcutaneous injection
15962307|NCT03171207|Device|Lite Run Gait Trainer|The Lite Run Gait Trainer is a novel device with pneumatic pants that can be used to assist with body support assisted gait therapy.
15962308|NCT03171207|Device|Current Harness System|There are a variety of harness systems (e.g., ceiling lift, Lite Gait) that are currently used to assist with body support assisted gait therapy.
15962309|NCT03171194|Drug|Low Dose Mesenchymal Stem Cells (MSCs)|Mesenchymal stromal/stem cells (MSCs) are cells that can be derived from umbilical cords, bone marrow, adipose tissue, and dental pulp, among other sites. MSCs have the ability to mediate a range of immuno-modulatory actions for both the innate and adaptive immune systems.
15962310|NCT03171181|Other|Vestibular reeducation|Balance quality was registered with static and dynamic posturography. For spatial orientation is was registered Visual vertical and visual orientation perception. Vestibular disability was also assessed. Variables were registered at the beginning and at the end of a vestibular rehabilitation in UPVD participants. Vestibular rehabilitation consisted of 10 sessions of vestibular rehabilitation using dynamic posturography and visual reeducation. Duration of each session: 40 minutes. Twice a week.
15962311|NCT03171168|Device|AposTherapy|AposTherapy is a home-based exercise program utilizing footwear that causes exercise with normal daily activity that may significantly improve function in patients with knee pain in general, and specifically knee osteoarthritis (OA).
15962312|NCT03171168|Other|Traditional Physical Therapy|Up to 20 sessions of traditional physical therapy
15962313|NCT03171155|Device|XPro System|Implantation of the XPro System
15962314|NCT03171142|Drug|Heliox|Heliox (21:79) via nasal cannula 2 litter per minutes
15962315|NCT03171142|Drug|Air|Air 21% via nasal cannula 2 litter per minutes
15962316|NCT03171129|Device|Adaptive Dynamic Inspiratory Nasal Apparatus|Oxygen will be administered via ADINA
15962317|NCT03171129|Device|High flow Nasal Canula|Oxygen will be administered via nasal canula
15962318|NCT03171116|Other|none intervention|it is not an interventional study; it is an observational study
15962319|NCT03171090|Other|sphenopalatine block with local anesthetic|bilateral ultrasonic guided sphenopalatine ganglion block using local anesthetic after induction of general anesthesia in maxilofacial cancer surgeries
15962320|NCT03171090|Other|sphenopalatine block with saline|bilateral ultrasonic guided sphenopalatine ganglion block using saline after induction of general anesthesia in maxilofacial cancer surgeries
15962321|NCT03171077|Other|Virtual Rehabilitation|It is the use of the NW games for rehabilitation of balance in post-stroke patients.
15962322|NCT03171077|Other|PNF Method|It is the use of the therapeutic exercises based on the PNF diagonals for rehabilitation of balance in post-stroke patients.
15962323|NCT03171077|Other|Virtual Rehabilitation and PNF Method|It is the use of the exercises based on the PNF diagonals and of the NW for rehabilitation of balance in post-stroke patients.
15962324|NCT03171064|Behavioral|Resistance and Endurance Exercise|Machine-based, 2x/week endurance and resistance training for 12 weeks
15962325|NCT03171051|Device|950 nm LED Device|Device to be used in aesthetic and cosmetic procedures which consists of a console and an applicator belt that delivers the treatment LED to the subject's skin.
15962326|NCT03171051|Device|1050nm Diode Laser Device|FDA approved laser device that has been shown to reduce fat in the flanks by heating the fat cells and causing them to burst. The contents of the cells are then cleared naturally by the body.
15962327|NCT03171038|Other|Telemonitoring|
15962328|NCT03171025|Drug|Nivolumab|Nivolumab at a dose of 480 mg will be administered as an IV infusion over 60 minutes every 4 weeks until disease recurrence or discontinuation due to unacceptable toxicity for a maximum of 12 treatments over an expected duration of 1 year.
15962329|NCT03171012|Other|Lower limbs CRT|cycle ergometer for lower limbs
15962330|NCT03171012|Other|Upper limbs CRT|cycle ergometer for upper limbs
15962331|NCT03171012|Other|Proprioceptive Neuromuscular Facilitation|Proprioceptive Neuromuscular Facilitation patterns will be performed in seated, dorsal, ventral and side.
15962332|NCT03171012|Other|respiration|respiration
15962333|NCT03170999|Other|Focus group interview|Focus group interviews will take place to discuss the key domains of COPD exacerbation which then will be used in the formation of the draft item set.
15962334|NCT03170999|Other|Draft item set|Items that form the draft item set will be subject to cognitive debriefing. Questions in the draft item set will collect information on whether the subjects with COPD have experienced that item during an exacerbation. Changes in this draft set will result in the formation of candidate item set.
15962335|NCT03170999|Other|Candidate item set|Item reduction will be done using candidate item set and the subjects will be asked to respond to the candidate items on a 4-point scale in terms of how that item changed with the onset of the last episode. Item reduction will take into account frequency and magnitude of items, floor and ceiling items and consistency between regions. The candidate item set will then be used for generation of CERT.
15962336|NCT03170986|Behavioral|Multisectoral agriculture and Microfinance Intervention|
15962337|NCT03170973|Other|Exercise|After a 12-hour fast, volunteers will collect blood in the antecubital vein to measure basal serum values. 12 after the first blood collection they will perform a physical exercise session on a treadmill. The same will be divided in 3 times: heating, conditioning and cooling. The heating will be of 7 minutes, the cooling of 5 minutes and the time of conditioning will correspond to the energy expenditure of 250Kcal with light intensity based on Borg's perception of effort, that is, in the original scale a value between 9 and 11. After 24 hours after the first blood collection the volunteers will return to the laboratory after a 12-hour fast and blood samples will be collected again.
15962338|NCT03170960|Drug|cabozantinib|Supplied as 60-mg and 20-mg tablets; administered orally daily at dose levels of 20 mg, 40 mg, or 60 mg.
15962339|NCT03170960|Drug|atezolizumab|Supplied as 1200-mg vials; administered as an IV infusion once every 3 weeks (q3w).
15962340|NCT03170960|Drug|cabozantinib|Supplied as 60-mg and 20-mg tablets; administered orally daily at the Cohort Review Committee-determined recommended dose from the Dose Escalation Stage
15962341|NCT03170960|Drug|cabozantinib|Supplied as 60-mg and 20-mg tablets; administered orally daily at 60 mg qd
15962372|NCT03170700|Behavioral|Nutrition program with in-person parental feeding content|Participants will attend the nutrition program (Eating Smart • Being Active) and be provided with in-person parental feeding content.
15963797|NCT03160521|Drug|Placebo of Risperidone ISM|Monthly IM injection in the gluteal or deltoid muscle.
15962342|NCT03170947|Device|Custom Insoles|"Custom insoles will make with CAD-CAM using a laser scanning and casting for its construction. All this needs the assistance of a computer. From the digital image of a positive of the limb in foam the insole will be obtained.
~Custom insoles make with direct adaptation technique (TAD) being of pvc resin. Once the resins are cut and with a temperature of 90º, they will be adapted to the foot (which will be protected with a sock) of the patient with the help of a vacuum. To this technique subtalar joint will be in a neutral position and metatarsal joints will be aligned."
15962343|NCT03170947|Device|Standardized insoles|Standardized insoles were done by EVA material with shore of 18 and 180 kg/cm3 and manufactured, with an extension of 3/4. It was in contact with heel and plantar arch.
15962344|NCT03170934|Behavioral|Psychotherapy skills class|Rapid access, large-scale, psychotherapy classes that are open format and delivered in lecture style. One class - Managing Difficult Emotions (MDE) - is an 8-session, DBT-informed program. The other class - Mindfulness-Based Cognitive Behavioral Therapy (CBTm) - is a 4-session program.
15962345|NCT03170921|Other|Angola|The rhythm performance (Angola) had duration of 90 seconds. During recovery period (post- intervention) in the moments 1, 3, 5, 7, and 9 minutes was measured the physiological and the perceptual variables of the study.
15962346|NCT03170921|Other|Benguela|The rhythm performance (Benguela) had duration of 90 seconds. During recovery period (post- intervention) in the moments 1, 3, 5, 7, and 9 minutes was measured the physiological and the perceptual variables of the study.
15962347|NCT03170921|Other|São Bento|The rhythm performance (São Bento) had duration of 90 seconds. During recovery period (post- intervention) in the moments 1, 3, 5, 7, and 9 minutes was measured the physiological and the perceptual variables of the study.
15962348|NCT03170908|Behavioral|Interpersonal Psychotherapy|Interpersonal Psychotherapy (IPT) is an empirically-validated time-limited treatment for depression
15962349|NCT03170895|Drug|Sorafenib|Sorafenib a kinase inhibitor indicated for the treatment of Unresectable hepatocellular carcinoma; Advanced renal cell carcinoma
15962350|NCT03170895|Drug|Omacetaxine Mepesuccinate Injection|Omacetaxine Mepesuccinate is a pharmaceutical drug substance that is indicated for treatment of chronic myeloid leukemia (CML)
15962354|NCT03170869|Device|Surefire Precision Infusion System|All patients enrolled in this protocol will receive DEB-TACE, which is the standard of care prescribed by their physician. Standard 5 Fr and 3 Fr catheters will be used to perform diagnostic angiography to map the hepatic vasculature to the tumor. Using standard technique, the target vessel feeding the tumor will be catheterized and DEB-TACE administered using the Surefire Precision catheter. The Doxorubicin dosing used in the DEB-TACE will be based upon tumor volume. DEB-TACE will be administered until the first of the following endpoints are reached: Achievement of target dose with stasis, leeching of contrast through the expandable tip and development of distal intrahepatic collaterals.
15962355|NCT03170856|Other|Sub-maximal exercise|Subjects will participate in aerobic exercise 5 days a week. This includes walking, biking, jogging and running. While participating in these activities, they will be wearing their Polar Wrist Unit and Heart Rate Monitor to help subjects track their exercise intensity. They will exercise for 20 minutes 5times a week at 60% of their maximum heart rate or 80% of their symptom limited heart rate.
15962356|NCT03170843|Device|use of plastic ring wound retractor|the experimental arm will use the plastic ring wound retractor for wound protection.
15962357|NCT03170830|Diagnostic Test|the diagnosis value of cUck2 in acute myocardial infarction.|Collect blood at different time points and compare cUck2 in three groups.
15962361|NCT03170791|Device|vagal nerve stimulation intervention|During exercise sessions the therapist will the therapist will press a switch to trigger a run of vagal nerve stimulation in time with the patient's activity. No further activity involved.
15962362|NCT03170765|Biological|Measles vaccine|Live attenuated measles vaccine of brands currently being used in National Immunization Schedule of India.
15962363|NCT03170752|Behavioral|Cardiovascular Assessment Screening Program (CASP)|Step 1. Identification of patients; Step 2. Screening utilizing appropriate tools; and Step 3. Actions to follow up on the screening results.
15962364|NCT03170739|Drug|Dexmedetomidine|Dexmedetomidine given during surgery.
15962365|NCT03170739|Drug|Dopamine|Dopamine given during surgery.
15962366|NCT03170726|Drug|arveles|Intraoperative and postoperative pain values between these three groups will be compared.
15962367|NCT03170726|Drug|intrafen 800 mg|ibuprofen 800 mg in normal saline 150 cc before operation will be given in 30 minutes. Intraoperative and postoperative pain values between these three groups will be compared.
15962368|NCT03170726|Other|plasebos|normal saline 150 cc before operation will be given in 30 minutes. Intraoperative and postoperative pain values between these three groups will be compared.
15962369|NCT03170713|Drug|arveles|800 mg ibuprofen and 50 mg dexketoprofen in 150 cc normal saline before operation will be given in 30 minutes. The edema size, mouth opening (trismus) will be recorded in all patients in the preoperative period, postoperative period, postoperative 48th hour and 1 st week.
15962370|NCT03170713|Drug|intrafen|800 mg ibuprofen in 150 cc normal saline before operation will be given in 30 minutes.The edema size, mouth opening (trismus) will be recorded in all patients in the preoperative period, postoperative period, postoperative 48th hour and 1 st week.
15962371|NCT03170713|Other|placebos|150 cc normal saline before operation will be given in 30 minutes.The edema size, mouth opening (trismus) will be recorded in all patients in the preoperative period, postoperative period, postoperative 48th hour and 1 st week.
15962373|NCT03170700|Behavioral|Nutrition program with online parental feeding content|Participants will attend the nutrition program (Eating Smart • Being Active). They will access parental feeding content online.
15962374|NCT03170687|Device|short foot cast|metatarsal foot cast
15962375|NCT03170687|Device|short leg cast|full short leg cast
15962376|NCT03170674|Other|FT21039|an electronic cigarette product
15962377|NCT03170674|Other|FT21092|an electronic cigarette product
15962378|NCT03170674|Other|FT21018|an electronic cigarette product
15962379|NCT03170661|Drug|Deep neuromuscular block|Deep neuromuscular block will be achieved with high dose rocuronium to achieve a depth of 1-2 twitches post tetanic count
15962380|NCT03170648|Device|Acupuncture|Acupuncture has been studied in clinical trials in cancer patients and has been shown to be helpful for management of pain, nerve damage from chemotherapy, and nausea
15962381|NCT03170635|Behavioral|Refreshing Recess program|6-week program integrated into recess in order to build capacity of recess supervisors to foster active play and socialization so that all students enjoy recess and socialization with peers.
15962382|NCT03170622|Diagnostic Test|Intervention group|This group will provide a stool sample that will be analysed for VOCs and followed up after 3 months
15962383|NCT03170609|Biological|Multivalent group B streptococcus vaccine|Various formulations at three dose levels
15962384|NCT03170609|Biological|Placebo|Saline Control
15962385|NCT03170596|Drug|tazarotene gel 0.1%|Patients will be instructed to apply 0.1% tazarotene gel as a thin film over the affected area once daily in the evening.
15962386|NCT03170596|Device|Microneedling|Microneedling is a method of percutaneous collagen induction
15962387|NCT03170583|Device|St. Jude Medical Tendril MRI™ lead|pacemaker, leads
15962388|NCT03170570|Device|intensity-modulated radiotherapy|IMRT: intensity modulated radiotherapy, Treatment schedule: 4-7 weeks, 20-35 fractions, unless the stop indications were met, treatment will continue.
15962389|NCT03170557|Other|Traditional chinese acupuncture|Traditional chinese acupuncture (somatopuncture points, auriculotherapy points, craniopuncture and wrist-ankle acupuncture). Simultaneously, the usual pharmacological treatment for pain is maintained, based on clinical needs.
15962390|NCT03170557|Other|Aspecific needle skin stimulation|Superficial needling of needles in skin areas outside the pain affected dermatome(s). Simultaneously, the usual pharmacological treatment for pain is maintained, based on clinical needs.
15962391|NCT03170544|Drug|MK-1092, 4.0 nmol/kg|MK-1092, 4.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
15962392|NCT03170544|Drug|MK-1092, 8.0 nmol/kg|MK-1092, 8.0 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
15962393|NCT03170544|Drug|MK-1092, 16 nmol/kg|MK-1092, 16 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
15962394|NCT03170544|Drug|MK-1092, 32 nmol/kg|MK-1092, 32 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
15962395|NCT03170544|Drug|MK-1092, 64 nmol/kg|MK-1092, 64 nmol/kg, SC, as a single dose under the euglycemic clamp, in participants
15962396|NCT03170544|Drug|Glargine 3.0 nmol/kg|Glargine 3.0 nmol/kg, SC, as a single dose
15962397|NCT03170544|Drug|Lispro 1.2 nmol/kg|Lispro (Humalog®), 1.2 nmol/kg, IV infusion SC over 3 hours as a single dose starting ~12 hours after MK-1092 administration.
15962398|NCT03170544|Drug|Placebo to glargine|Placebo to glargine, SC, as a single dose
15962399|NCT03170544|Drug|Placebo to MK-1092|Placebo to MK-1092, SC, as a single dose
15962400|NCT03170544|Other|Dextrose|20% solution for continuous infusion for the duration of the glucose clamp as needed to maintain blood sugar at pre-clamp target levels.
15962401|NCT03170544|Biological|Insulin|Participants will receive insulin IV, as needed, prior to dosing and clamp initiation and after dosing.
15962402|NCT03170531|Diagnostic Test|Custom Designed Spine Coil|During the participant's MR scan, the custom spine coil will be placed between the participant and the immobilization mold. image parameters will be optimized for spine anatomy for the pulse sequences which are standard for MR imaging.
15962403|NCT03170531|Diagnostic Test|FDA approved spine coil|During the participant's MR scan, the FDA spine coil will be placed between the participant and the immobilization mold. image parameters will be optimized for spine anatomy for the pulse sequences which are standard for MR imaging. Volunteers may receive up to 3 scans to allow for comparisons of changes to the calibration files as we continue to test the coil and improve its performance.
15962407|NCT03170505|Procedure|repairing fistula|A tailored piece of Acellular Dermal Matrix or Conchal Cartilage will be placed between the oral and nasal layers for repair of a Cleft Palate.
15962408|NCT03170492|Other|RehaCom Computerized Cognitive Training for 480 minutes|Student OT doctoral researchers will guide the subject when participating in the RehaCom program. RehaCom is computer hardware and software designed for assisted cognitive rehabilitation. The program is designed to target specific aspects of attention, concentration, memory, perception, and problem-solving. As the training goes on, the tasks will become easier or harder depending on the subject's performance. The first session will begin with a screening module with an example and a practice session to make sure the client understands the task. After screening, the results page shows the subject's performance compared with age-matched norms. This gives a helpful indication as to the severity of the deficit and advises the researcher on the particular training module to be used. The subject will continue the training modules for a total of 480 minutes of training over 12 weeks.
15962409|NCT03170492|Other|Pencil-and-Paper Cognitive Training for 480 minutes|Student OT doctoral researchers will engage the subject in various pen-and-paper exercises designed to improve cognitive functions: attention and concentration, memory, language, calculation, and orientation. These could include, but are not limited to: word puzzles, calculation or number puzzles, and map reading. The subject will continue the training modules for a total of 480 minutes of training over 12 weeks.
15962410|NCT03170479|Dietary Supplement|Vitamin D|Two doses of Vitamin D supplementation in ampoules form (ED3) were procured. Ampoule contains Cholecalciferol in 200,000 IU both for oral and intra muscular use.
15962411|NCT03170479|Dietary Supplement|Ready to Use Therapeutic Food (RUTF)|RUTF is recommended by WHO for sever malnourished children in community settings as a therapeutic diet. The quantity depends upon the child body weight.
15962412|NCT03170466|Behavioral|Primary Palliative Care|The intervention will span 4 domains: symptom management (e.g., dyspnea), psychosocial support (e.g., anxiety), advance care planning (e.g., understanding prognosis and electing a proxy) and care coordination (e.g., communication across providers).
15962413|NCT03170453|Behavioral|Cognitive Enhancement Therapy|An 18-month comprehensive, small group approach for the remediation of cognitive deficits in neurodevelopmental disorders consisting of individual sessions and 45 group training sessions in social cognition that are integrated with approximately 60 hours of computer assisted training in attention, memory, and problem solving skills.
15962414|NCT03170453|Behavioral|Enriched Supportive Therapy|An 18-month intervention that uses individual supportive therapy to help adults learn about autism spectrum disorder, manage their emotions and stress, improve their social skills, and cope with everyday problems. Participants will learn about the impact of stress on their lives, and how to identify their own early cues of distress and apply effective coping strategies.
15962415|NCT03170440|Other|Transcutaneous nerve stimulation location 1|Non-invasive stimulation by transcutaneous electrical nerve stimulation device in test location
15962416|NCT03170440|Other|Transcutaneous nerve stimulation location 2|Stimulation will be performed using electrodes placed in alternate location.
15962417|NCT03170427|Device|Impedance cardiography|hemodynamic variation measured by impedance cardiography in healthy pregnant undergoing to cesarean section treated with 8mg or 6mg of levobupivacaine
15962418|NCT03170427|Diagnostic Test|Sensory levels|Sensory levels are checked using ice test cold
15962419|NCT03170427|Diagnostic Test|Motor block|motor block is measured by modified Bromage scale
15962420|NCT03170427|Diagnostic Test|Sensory level|Sensory levels are checked using touch with alcohol puffs
15962421|NCT03170401|Dietary Supplement|Protein supplementation|half the subjects will receive protein supplementation via enteral feedings and half will not receive the protein supplementation
15962422|NCT03170388|Drug|IDP-126 Gel|Gel
15962423|NCT03170388|Drug|IDP-126 Component A|Component A
15962424|NCT03170388|Drug|IDP-126 Component B|Component B
15962425|NCT03170388|Drug|IDP-126 Component C|Component C
15962426|NCT03170388|Drug|IDP-126 Vehicle Gel|Vehicle Gel
15962427|NCT03170375|Behavioral|Performance of WHEELS-I in promoting DASH/SRD adoption|Participants will receive the WHEELS-I electronically-delivered tailored messaging intervention in addition to motivational interviewing-based counseling.
15962428|NCT03170375|Behavioral|Effects of a 2-week DASH/SRD intervention vs. control diet on HFpEF functional cardiovascular risk factors|Participants will be randomized to the sequence DASH/SRD-control diet or control diet-DASH/SRD, and consume the diets for 14 days each.
15962429|NCT03170362|Other|Pharmacogenetic Test|The intervention is a battery of pharmacogenetic test results that mostly affect the metabolism of antidepressants and other medications.
15962430|NCT03170349|Device|Mitral Valve Repair|Minimal Invasive Transcatheter Mitral Valve Repair
15962431|NCT03170336|Drug|Amiloride|Amiloride first for 8 weeks, then for a washout for 4 weeks, and cross over to receive hydrochlorothiazide for another 8 weeks.
15962432|NCT03170336|Drug|Hydrochlorothiazide|hydrochlorothiazide first for 8 weeks, then for a washout for 4 weeks, and cross over to receive amiloride for another 8 weeks.
15962433|NCT03170323|Drug|Mycophenolate Mofetil|steroid 1mg/kg/d and Mycophenolate mofetil 500mg bid
15962434|NCT03170323|Drug|Cyclosporins|steroid 0.15mg/kg/d and Cyclosporin 3-5mg/kg/d
15962435|NCT03170310|Drug|Apatinib|Apatinib500 mg,po,qd,continuous dosing until PD, death or not tolerated toxicity.
15962436|NCT03170297|Other|Research interventions of blood sampling and data collection|Patient-Specific Functional Scale (PSFS) survey will be administered to patients to record symptoms at both the time of evaluation in the emergency department and in follow up by phone at 3, 7, 14, 21 and 28 days after discharge from the emergency department or hospital. The rest of the patients' care will be as usual care, and patients will have had research interventions of blood sampling and data collection as noted in the previously approved SC2i Tissue Data Acquisition Protocol (TDAP) Pro00054947 (ClinicalTrial.gov ID: NCT02182180).
15962437|NCT03170284|Drug|Bevacizumab|Bevacizumab is prescribed by physicians as per SPC.
15962438|NCT03170271|Drug|Benralizumab (Medi-563)|30mg Benralizumab administered as a subcutaneous injection at Visit 4 (day 0), Visit 6 (day 28 +/- 3 days), Visit 7 (day 56 +/- 3 days) and Visit 9 (day 112 +/- 3 days) In the open label ANDHI IP sub study, all patients will receive benralizumab subcutaneously at Day 168 (Week 24), Day 196 (Week 28), Day 224 (Week 32), Day 280 (Week 40), Day 336 (Week 48), Day 392 (Week 56), Day 448 (Week 64), and Day 504 (Week 72).
15962439|NCT03170271|Drug|Placebo|Placebo administered as a subcutaneous injection at Visit 4 (day 0), Visit 6 (day 28 +/- 3 days), Visit 7 (day 56 +/- 3 days) and Visit 9 (day 112 +/- 3 days)
15962440|NCT03170258|Device|Neurofeedback (from fMRI and/or EEG)|During part of the task, a feedback display (e.g., thermometer stimulus) will be used to display the average brain activity for each participant. This signal will be acquired ~ every 1 second during the neurofeedback session and will dynamically update to reflect ongoing changes in brain activity. This continuously updated display is the primary feedback mechanism provided to the participant.
15962441|NCT03170245|Diagnostic Test|Interleukin-6|serum samples used for doing the test by ELISA
15962442|NCT03170245|Diagnostic Test|HsC-RP|serum samples used for doing the test by ELISA
15962443|NCT03170245|Diagnostic Test|Adiponectin level|serum samples used for doing the test by ELISA
15962444|NCT03170245|Diagnostic Test|Carotid intima media thickness|Done by carotid doppler
15962445|NCT03170232|Drug|Danirixin 35 mg tablets|Danirixin 35 mg (as hydrobromide hemihydrate salt) is a white film coated oval shaped tablet. It will be provided in a labeled high-density polyethylene (HDPE) bottle with desiccant.
15962446|NCT03170232|Drug|Placebo|Placebo is a white film coated oval shaped tablet. It will be provided in a labeled HDPE bottle with desiccant.
15962447|NCT03170232|Device|Metered dose inhaler (MDI) sensor device|MDI sensor devices will be fitted onto rescue medication MDI devices to electronically record rescue medication usage.
15962520|NCT03169777|Drug|leucovorin|Calcium N-[p-[[[(6RS)-2-amino-5-formyl-5,6,7,8-tetrahydro-4-hydroxy-6-pteridinyl]methyl]amino]benzoyl]-L-glutamate (1:1)
15962448|NCT03170232|Drug|Rescue medication|Subjects may continue to use rescue medication(s) via their usual route. Allowed medications are: short acting beta agonists (SABA) (e.g., albuterol/salbutamol); short acting muscarinic antagonists (SAMA) (e.g., ipratropium); short acting combination (SABA/SAMA) bronchodilators, (e.g. Duoneb, Combivent)
15962449|NCT03170219|Combination Product|subcutaneous furosemide and sc2wear device|subcutaneous furosemide administered via sc2wear device vs. standard of care
15962450|NCT03170206|Drug|Binimetinib|Binimetinib is also an oral drug which stops a signal that a cell receives, instructing it to grow.
15962451|NCT03170206|Drug|Palbociclib|It is a selective inhibitor of the cyclin-dependent kinases CDK4 and CDK6
15962452|NCT03170193|Drug|AMG 529|Ascending single doses of AMG 529 by subcutaneous (SC) or intravenous (IV) injection
15962453|NCT03170193|Drug|Placebo|Single doses of matching placebo by SC or IV injection
15962454|NCT03170180|Drug|Sunitinib|sunitinib 37.5mg daily
15962455|NCT03170180|Drug|Gefitinib|Gefitinib 250mg daily
15962456|NCT03170180|Drug|Imatinib|Imatinib 400mg daily
15962457|NCT03170154|Device|Clareon aspheric hydrophobic acrylic monofocal IOL|Ultraviolet-absorbing and blue light-filtering IOL composed of high refractive-index foldable and flexible acrylic material. IOLs are implantable medical devices intended for long term use over the lifetime of the cataract subject.
15962458|NCT03170141|Biological|Antigen-specific IgT cells|Tumor antigen-specific IgT cells are infused intravenously or directly to the tumor location of the patients in a three-day split-dose regimen（day 0,10%; day1, 30%; day2, 60%）to complete a total targeted dose. Drug: cyclophosphamide 250 mg/m^2 d1-3; Drug: Fludarabine 25mg/m^2 d1-3
15962459|NCT03170128|Procedure|Outpatient physical therapy in addition to standard follow-up visits|Patients in Group 1 will be given a prescription for outpatient physical therapy.
15962460|NCT03170128|Behavioral|Home exercises in addition to standard follow-up visits|Patients in Group 2 will be carefully instructed on home exercises for range of motion and strengthening of their affected elbow. All therapy regimens will be prescribed at initial presentation, as is the current practice. All other care will be identical for patients in both groups. This
15962461|NCT03170115|Drug|Aspirin|chemoradiotherapy with capecitabine and aspirin Aspirin daily during chemoradiotherapy
15962462|NCT03170115|Drug|Placebo Oral Tablet|chemoradiotherapy with capecitabine and placebo Placebo daily during chemoradiotherapy
15962463|NCT03170102|Other|Building capacity through education|Participants engaged in 2 webinars and 3 online discussions following reading selected material.
15962464|NCT03170089|Behavioral|Oral Health Educational Program|Oral Hygiene methods learned
15962465|NCT03170063|Procedure|Procedure/Surgery: Biofluid samplings|Biofluid samplings (blood and cerebrospinal fluid (CSF))
15962466|NCT03170050|Device|YYD701-2|HA Filler
15962467|NCT03170050|Device|Restylane Perlane Lidocaine|HA Filler
15962468|NCT03170037|Procedure|Standard V-E ventilation technique|For the two-handed standard V-E technique, the facemask is first placed over the bridge of the nose and mouth and then held in place by performing at two-handed jaw thrust maneuver with the index and second finger of each hand and maintaining mask contact with the patient's face by using both thumbs with mouth open. A head-tilt is performed by applying a caudal force on the mandible and mask.
15962469|NCT03170037|Procedure|Reversal V-E ventilation technique|While using reversal V-E technique, the anesthesia provider stands 180 degrees opposite from the head of the bed. Thenar eminence and thumbs secure the mask around the nose while the remaining fingers pull the mandible anteriorly while keeping the mouth open.
15962470|NCT03170011|Behavioral|Exercise using the Biodex Sit2Stand Trainer|Week 1-2 - Focused on lower intensity, higher volume, comfortable/self-selected velocity Week 3-4 - Focus on higher intensity, lower volume, comfortable/self-selected velocity Week 5 - Focus on moderate intensity, moderate volume, transitioning to higher velocity Week 6 - Focus on moderate intensity, moderate volume, high velocity
15962471|NCT03169998|Device|EV1000 platform|a continuous arterial pressure monitoring was performed via EV1000/ FloTrac (Edwards Lifesciences, Irvine, CA, USA) (Fig 1) with the continuous monitoring of cardiac index (CI), stroke volume index (SVI) and stroke volume (SV).
15962472|NCT03169985|Drug|Rosuvastatin 10 mg plus ezetimibe 10 mg orally once a day|After the initial 12 months, randomized intervention will be stopped and then this arm will be received either usual dose rosuvastatin plus ezetimibe or high-dose rosuvastatin during the next 24 months by clinical judgement.
15962473|NCT03169985|Drug|Rosuvastatin 20 mg orally once a day|After the initial 12 months, randomized intervention will be stopped and then this arm will be received either usual dose rosuvastatin plus ezetimibe or high-dose rosuvastatin during the next 24 months based by clinical judgement.
15962474|NCT03169972|Biological|ADYNOVATE|Antihemophilic Factor (Recombinant), PEGylated
15962475|NCT03169959|Drug|2.5 mg Saxagliptin tablet|A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with Type 2 diabetes mellitus (T2DM).
15962476|NCT03169959|Drug|5 mg dapagliflozin / 1000 mg metformin XR tablet|"Dapagliflozin - An inhibitor of sodium-glucose co-transporter 2 (SGLT-2), reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.
~Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization."
15962477|NCT03169959|Drug|Triple FCDP - 2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR|"Saxagliptin - A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with T2DM.
~Dapagliflozin - An inhibitor of SGLT-2, reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.
~Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization."
15962478|NCT03169959|Drug|5 mg saxagliptin|A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with T2DM.
15962479|NCT03169959|Drug|10 mg dapagliflozin / 1000 mg metformin XR tablet|"Dapagliflozin - An inhibitor of SGLT-2, reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.
~Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization."
15962480|NCT03169959|Drug|Triple FCDP - 5 mg saxagliptin / 10 mg dapagliflozin / 1000 mg metformin XR|"Saxagliptin - A competitive dipeptidyl peptidase-4 (DPP-4) inhibitor, slows the inactivation of the incretin hormones, thereby increases their bloodstream concentrations and reduces fasting and post-prandial glucose concentrations in a glucose-dependent manner in subjects with T2DM.
~Dapagliflozin - An inhibitor of SGLT-2, reduces re-absorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.
~Metformin - Lowers both basal and post-prandial plasma glucose by decreasing hepatic glucose production and intestinal absorption of glucose; improves insulin sensitivity by increasing peripheral glucose uptake and utilization."
15962481|NCT03169946|Procedure|RCT with CHX-MTZ,OFD|Endodontic treatment using chlorhexidine metronidazole combination as an intracanal medicament along with open flap debridement .
15962482|NCT03169946|Procedure|RCT with CHX,OFD|Endodontic treatment using chlorhexidine as an intracanal medicament along with surgical periodontal therapy in form of open flap debridement.
15962483|NCT03169933|Radiation|Combined, intensified and modulated adjuvant radiotherapy|
15962484|NCT03169920|Procedure|Modified-Minimally Invasive Surgical Technique + PRF|
15962485|NCT03169920|Procedure|Modified-Minimally Invasive Surgical Technique|
15962486|NCT03169907|Radiation|Mid trimesteric fetal ultrasonography|"Venous and arterial Doppler indices:
~Middle cerebral artery (MCA) peak systolic velocity (PSV):
~Umbilical Artery Pulsitility Index (PI) and Resistant Index (RI):
~Ductus venosus (DV) Doppler:
~Cardiac functions:
~Global cardiac function evaluated by Modified Myocardial Performance Index (Mod-MPI):
~Systolic cardiac function using the four-dimensional (4D) spatiotemporal imaging correlation (STIC) ultrasound technique:
~Diastolic cardiac function evaluated by relationship between the maximal velocities of the E and A waveforms of ventricular filling (E/A ratio)"
15962487|NCT03169894|Drug|MDGN-002|MDGN-002 is a fully human IgG4 monoclonal antibody specific to human LIGHT.
15962488|NCT03169881|Drug|Darbepoetin|Darbepoetin 10 micrograms/kg/once every week (IV or SC). Infants will be treated until 35 completed weeks gestation, discharge, or transfer to another hospital.
15962489|NCT03169881|Drug|Placebo|normal saline for IV administration, or sham dosing. Infants will be treated until 35 completed weeks gestation, discharge, or transfer to another hospital.
15962490|NCT03169868|Diagnostic Test|Sano Patient Medication Profile|The Sano Patient Medication Profile (PMP) is a graphical report comparing prescribed medications to LC/MS/MS-detected drugs from patient blood samples
15962491|NCT03169855|Diagnostic Test|Slit lamp (LOCS III Score)|Diagnostic procedure only
15962492|NCT03169842|Device|pancreatic cyst fluid glucose analysis using a bedside glucometer|Small amount of pancreatic cyst fluid will be analyzed for glucose level using a bedside glucometer from EUS-FNA procedures.
15962493|NCT03169829|Dietary Supplement|Standard Diet|"Adapted from National Kidney Foundation guidelines for HD1
~Animal only Protein
~Refined only Grains
~Limit Dairy
~Low-k only"
15962494|NCT03169829|Dietary Supplement|Low-k|"•¼ Animal, ¾ Plant Proteins
~•½ Refined, ½ Whole Grain
~Limit Dairy, provide Soymilk Dairy
~Low-k only Fruit and Vegetables"
15962495|NCT03169829|Dietary Supplement|Standard|"•¼ Animal, ¾ Plant Proteins
~Refined, ½ Whole Grain
~•Limit Dairy, provide Soymilk Dairy
~Low-k, Fruit and Vegetables
~High-k Fruit and Vegetables"
15962496|NCT03169816|Drug|Lorcaserin|Lorcaserin 10mg, twice daily
15962497|NCT03169816|Drug|Placebo|Matched placebo for lorcaserin condition dosed twice daily
15962498|NCT03169803|Device|NeuroTronik CANS Therapy™ System|The NeuroTronik CANS Therapy™ System is a percutaneous, catheter-based, bedside electrical stimulation system. The System consists of the single-use, disposable NeuroCatheter™ and NeuroCatheter™ Placement Kit, along with the reusable, bedside NeuroModulator™ Development System, and the NeuroTronik CANS Therapy™ Cable.
15962499|NCT03169790|Biological|avelumab|Fully human anti-PD-L1 IgG1 lambda monoclonal antibody
15962500|NCT03169790|Biological|bevacizumab|Recombinant human anti-VEGF IgG1 monoclonal antibody
15962501|NCT03169790|Drug|capecitabine|5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine
15962502|NCT03169790|Drug|cyclophosphamide|2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
15962503|NCT03169790|Drug|5-Fluorouracil (5-FU)|5-fluoro-2,4 (1H,3H)-pyrimidinedione
15962504|NCT03169790|Drug|leucovorin|Calcium N-[p-[[[(6RS)-2-amino-5-formyl-5,6,7,8-tetrahydro-4-hydroxy-6-pteridinyl]methyl]amino]benzoyl]-L-glutamate (1:1)
15962505|NCT03169790|Drug|nab-paclitaxel|5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine
15962506|NCT03169790|Drug|Lovaza|Omega-3-acid ethyl esters
15962507|NCT03169790|Drug|Oxaliplatin|cis-[(1 R,2 R)-1,2-cyclohexanediamine-N,N'] [oxalato(2-)- O,O'] platinum
15962508|NCT03169790|Drug|rituximab|Chimeric murine/human anti-CD20 monoclonal IgG1 kappa antibody
15962509|NCT03169790|Radiation|Stereotactic Body Radiation Therapy|(SBRT)
15962510|NCT03169790|Biological|ALT-803|recombinant human super agonist interleukin-15 (IL-15) complex
15962511|NCT03169790|Biological|ETBX-061|Ad5 [E1-, E2b-]-mucin 1[MUC1]
15962512|NCT03169790|Biological|haNK|NK-92 [CD16.158V, ER IL-2], Suspension for Intravenous [IV] Infusion
15962513|NCT03169777|Biological|avelumab|Fully human anti-programmed death-ligand 1 (PD-L1) immunoglobulin (Ig)G1 lambda monoclonal antibody
15962514|NCT03169777|Biological|bevacizumab|Recombinant human anti-vascular endothelial growth factor (VEGF) IgG1 monoclonal antibody
15962515|NCT03169777|Drug|capecitabine|5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine
15962516|NCT03169777|Biological|cetuximab|Recombinant human/mouse chimeric anti-epidermal growth factor receptor (EGFR) IgG1 monoclonal antibody
15962517|NCT03169777|Drug|Cyclophosphamide|2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
15962518|NCT03169777|Drug|5-Fluorouracil (5-FU)|5-fluoro-2,4 (1H,3H)-pyrimidinedione
15962519|NCT03169777|Drug|fulvestrant|7-alpha-[9-(4,4,5,5,5-pentafluoropentylsulphinyl) nonyl]estra-1,3,5-(10)- triene-3,17-beta-diol
15962521|NCT03169777|Drug|nab paclitaxel|5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine
15962522|NCT03169777|Biological|nivolumab|Human anti-programmed cell death protein 1 (PD-1) IgG4 kappa monoclonal antibody
15962523|NCT03169777|Drug|Lovaza|Omega-3-acid ethyl esters
15962524|NCT03169777|Drug|oxaliplatin|cis-[(1 R,2 R)-1,2-cyclohexanediamine-N,N'] [oxalato(2-)- O,O'] platinum
15962525|NCT03169777|Radiation|Stereotactic Body Radiation Therapy|(SBRT)
15962526|NCT03169777|Biological|ALT-803|recombinant human super agonist interleukin-15 (IL-15) complex
15962527|NCT03169777|Biological|ETBX-011|adenovirus serotype-5 [Ad5] [E1-, E2b-]-carcinoembryonic antigen [CEA] vaccine
15962528|NCT03169777|Biological|ETBX-021|Ad5 [E1-, E2b-]-human epidermal growth factor receptor 2 [HER2] vaccine
15962529|NCT03169777|Biological|ETBX-051|Ad5 [E1-, E2b-]-Brachyury vaccine
15962530|NCT03169777|Biological|ETBX-061|Ad5 [E1-, E2b-]-mucin 1 [MUC1] vaccine
15962531|NCT03169777|Biological|GI-4000|RAS yeast vaccine
15962532|NCT03169777|Biological|GI-6207|CEA yeast vaccine
15962533|NCT03169777|Biological|GI-6301|Brachyury yeast vaccine
15962534|NCT03169777|Biological|haNK|NK-92 [CD16.158V, ER IL-2], Suspension for Intravenous [IV] Infusion
15962535|NCT03169764|Biological|Avelumab|Fully human anti-PD-L1 IgG1 lambda monoclonal antibody
15962536|NCT03169764|Biological|Bevacizumab|Recombinant human anti-vascular endothelial growth factor (VEGF) immunoglobulin (Ig) G1 monoclonal antibody
15962537|NCT03169764|Drug|Capecitabine|5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine
15962538|NCT03169764|Biological|Cetuximab|Recombinant human/mouse chimeric anti-epidermal growth factor receptor (EGFR) IgG1 monoclonal antibody
15962539|NCT03169764|Drug|Cisplatin|(SP-4-2)-diamminedichloroplatinum(II)
15962540|NCT03169764|Drug|cyclophosphamide|2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
15962541|NCT03169764|Drug|5-Fluorouracil (5-FU)|5-fluoro-2,4 (1H,3H)-pyrimidinedione
15962542|NCT03169764|Drug|fulvestrant|7-alpha-[9-(4,4,5,5,5-pentafluoropentylsulphinyl) nonyl]estra-1,3,5-(10)- triene-3,17-beta-diol
15962543|NCT03169764|Drug|leucovorin|Calcium N-[p-[[[(6RS)-2-amino-5-formyl-5,6,7,8-tetrahydro-4-hydroxy-6-pteridinyl]methyl]amino]benzoyl]-L-glutamate (1:1)
15962544|NCT03169764|Drug|nab-paclitaxel|5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine
15962545|NCT03169764|Biological|nivolumab|Human anti-PD-1 IgG4 kappa monoclonal antibody
15962546|NCT03169764|Drug|Lovaza|Omega-3-acid ethyl esters
15962547|NCT03169764|Radiation|Stereotactic Body Radiation Therapy|(SRBT)
15962548|NCT03169764|Biological|ALT-803|recombinant human super agonist interleukin-15 (IL-15) complex [also known as IL 15N72D:IL-15RαSu/IgG1 Fc complex]
15962549|NCT03169764|Biological|ETBX-011|adenovirus serotype-5 [Ad5] [E1-, E2b-]-carcinoembryonic antigen (CEA) vaccine
15962550|NCT03169764|Biological|ETBX-021|Ad5 [E1-, E2b-]-human epidermal growth factor receptor 2 (HER2) vaccine
15962551|NCT03169764|Biological|ETBX-051|Ad5 [E1-, E2b-]-Brachyury vaccine
15962552|NCT03169764|Biological|ETBX-061|Ad5 [E1-, E2b-]-mucin 1 (MUC1) vaccine
15962553|NCT03169764|Biological|GI-4000|Ras yeast vaccine
15962554|NCT03169764|Biological|GI-6207|CEA yeast vaccine
15962555|NCT03169764|Biological|GI-6301|Brachyury yeast vaccine
15962556|NCT03169764|Biological|haNK|NK-92 [CD16.158V, ER IL-2], Suspension for Intravenous [IV] Infusion
15962557|NCT03169751|Device|Brain Sentinel Monitoring and Alerting System|The Brain Sentinel Monitoring and Alerting System is indicated for use as an adjunct to seizure monitoring in adults in the home or healthcare facilities during periods of rest. The device is to be used on the belly of the biceps muscle to analyze surface electromyographs (sEMG) signals that may be associated with generalized tonic-clonic (GTC) seizures and to provide an alarm to alert caregivers of unilateral, appendicular, tonic extension that could be associated with a GTC seizure. The System records and stores sEMG data for subsequent review by a trained healthcare professional.
15962558|NCT03169738|Biological|avelumab|Fully human anti-PD-L1 IgG1 lambda monoclonal antibody
15962559|NCT03169738|Biological|Bevacizumab|Recombinant human anti-vascular endothelial growth factor (VEGF) immunoglobulin (Ig) G1 monoclonal antibody
15962560|NCT03169738|Drug|Capecitabine|5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine
15962561|NCT03169738|Drug|Cisplatin|(SP-4-2)-diamminedichloroplatinum(II)
15962562|NCT03169738|Drug|cyclophosphamide|2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
15962563|NCT03169738|Drug|5-Fluorouracil (5-FU)|5-fluoro-2,4 (1H,3H)-pyrimidinedione
15962564|NCT03169738|Drug|fulvestrant|7-alpha-[9-(4,4,5,5,5-pentafluoropentylsulphinyl) nonyl]estra-1,3,5-(10)- triene-3,17-beta-diol
15962565|NCT03169738|Drug|leucovorin|Calcium N-[p-[[[(6RS)-2-amino-5- formyl-5,6,7,8-tetrahydro-4-hydroxy-6- pteridinyl]methyl]amino]benzoyl]-L-glutamate (1:1)
15962566|NCT03169738|Drug|nab paclitaxel|5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11- en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine
15962567|NCT03169738|Biological|nivolumab|Human anti-PD-1 IgG4 kappa monoclonal antibody
15962568|NCT03169738|Drug|Lovaza|Omega-3-acid ethyl esters
15962569|NCT03169738|Drug|Oxaliplatin|cis-[(1 R,2 R)-1,2-cyclohexanediamine-N,N'] [oxalato(2-)- O,O'] platinum
15962570|NCT03169738|Radiation|Stereotactic Body Radiation Therapy|(SRBT)
15962571|NCT03169738|Biological|ALT-803|recombinant human super agonist interleukin-15 (IL-15) complex [also known as IL15N72D:IL-15RαSu/IgG1 Fc complex]
15962572|NCT03169738|Biological|ETBX-011|adenovirus serotype-5 [Ad5] [E1-, E2b-]-carcinoembryonic antigen [CEA] vaccine
15962573|NCT03169738|Biological|ETBX-021|Ad5 [E1-, E2b-]-human epidermal growth factor receptor 2 [HER2] vaccine
15962574|NCT03169738|Biological|ETBX-051|Ad5 [E1-, E2b-]-Brachyury vaccine
15962575|NCT03169738|Biological|ETBX-061|Ad5 [E1-, E2b-]-mucin 1 [MUC1] vaccine
15962576|NCT03169738|Biological|GI-4000|Ras yeast vaccine
15962577|NCT03169738|Biological|GI-6207|CEA yeast vaccine
15962578|NCT03169738|Biological|GI-6301|Brachyury yeast vaccine
15962579|NCT03169738|Biological|haNK|NK-92 [CD16.158V, ER IL-2], Suspension for Intravenous [IV] Infusion
15962580|NCT03169725|Biological|Inactivated Poliomyelitis Vaccine (Sabin strain)|Investigational IPV based on Sabin strain (LBVC). Should be injected by intramuscular three injections in the anterolateral aspect of thigh at 6, 10 and 14 weeks of age.
15962581|NCT03169725|Biological|Inactivated Poliomyelitis Vaccine (Salk strain)|Commercialized IPV based on Salk strain (Imovax Polio). Should be injected by intramuscular three injections in the anterolateral aspect of thigh at 6, 10 and 14 weeks of age.
15962582|NCT03169712|Behavioral|Cognitive Behavioral Therapy for PTSD|Trauma-focused CBT protocol elaborated by Marchand and Guay from the Trauma Studies Centre at Louis-H. Lafontaine Hospital in Montreal and adapted from Foa, Hembree and Rothbaum (2007)
15962583|NCT03169712|Behavioral|Imagery Rehearsal Therapy|IRT protocol published by Nappi and collaborators (2010)
15962584|NCT03169686|Behavioral|Cognitive and Behavioral Intervention|Participants who allocate to the intervention group will receive regular messages providing smoking cessation related information, such as advice, support, and distraction by professional team.
15962585|NCT03169673|Diagnostic Test|Hyperpolarized Helium 3 Magnetic Resonance Imaging|Hyperpolarized noble gas imaging using Helium-3 has been used to explore structural and functional relationships in the lung in patients with lung disease and healthy controls. In contrast to proton-based MRI imaging, 3He gas is used as a contrast agent to directly visualize the airways, and thus ventilation. Whereas the normal density of gas is too low to produce an easily detectable signal, this is overcome by artificially increasing the amount of polarization per unit volume using optical pumping.
15962586|NCT03169660|Drug|Vascular endothelial growth factor trap-eye|Intravitreal injection of vascular endothelial growth factor trap-eye During the first 3 months, 3 monthly injections are performed After 3 serial injections, additional injections are performed once per 2 months until 48 weeks after the initial injection.
15962587|NCT03169647|Behavioral|Listening-based intervention|Participants will listen to pre-specified material on a CD
15962588|NCT03169634|Procedure|short or long stemmed rTKR cemented|An evaluation of the outcomes of different ways of performing revision total knee replacement surgery
15962589|NCT03169634|Procedure|Cone with short stem|Revision knee replacement using a metaphyseal cone and then a knee replacement with short stems is cemented in to it
15962590|NCT03169634|Procedure|Cone with long stem|Revision knee replacement using a metaphyseal cone and then a knee replacement with long stems is cemented in to it
15962591|NCT03169621|Procedure|Endometrial Biopsy and endometrial fluid collection|"On day 5 of the Hormonal Replacement Therapy (after 5 days of progesterone administration), the doctor will perform endometrial fluid aspiration (EF) followed by an endometrial biopsy (EB) the same day of hysteroscopy that is performed as usual clinical practice. EF sample will be analyzed by molecular techniques (Next Generation Sequencing) for the detection of infectious agents and the EB sample will be divided into three parts, one of them will be used for molecular analysis (as control of the bacterial content present in the EF) and the others will be used for microbiological analysis and histological techniques respectively.
~The Assisted Reproductive Treatment (ART) will be performed once the specialist considers it appropriated according to the clinical standard practice and the reproductive rates will be correlated with the diagnosis of CE comparing the results of ART before and after its diagnosis of CE."
15962592|NCT03169595|Procedure|Surgery|Patients affected by epithelioid hemangioma treated with surgery
15962593|NCT03169582|Drug|Avanafil|Drug administration (Avanafil)
15962594|NCT03169582|Drug|Sildenafil|Drug administration (Sildenafil)
15962595|NCT03169569|Procedure|Endo-clot™ (EndoClot Plus, Unc., Santa Clara, CA, USA) group|For patients in the study group, after hemostasis on the post-resection ulcer using conventional method and removal of specimen, Endo-clot™ (EndoClot Plus, Unc., Santa Clara, CA, USA) was applied immediately onto the post-resection surface.
15962596|NCT03169569|Procedure|Hemostatic forceps Only (Coagrasper®, Olympus, Japan) group|All ESDs were performed according to the standard procedure sequence in the hemostatic group and control group except hemostatic powder application.
15962597|NCT03169556|Device|Video-laryngoscope guided lightwand|After anesthetic induction,the difficult airway is simulated by wearing a semi-hard neck collar. For intubation, video-laryngoscope is inserted into the oral cavity ntil the epiglottis tip was visible without lifting the epiglottic vallecula. Then, the endotracheal tube with lightwand is inserted toward the midline under the epiglottis and the intubation is performed looking the transilluminated light of lightwand.
15962598|NCT03169556|Device|lightwand alone|After anesthetic induction,the difficult airway is simulated by wearing a semi-hard neck collar. Then, the endotracheal tube with lightwand is inserted and the intubation is performed with conventional method (blind technique by confirming transillumination).
15962599|NCT03169543|Behavioral|Sleep deprivation|36-hours total sleep deprivation
15962600|NCT03169530|Other|Alcohol|~15 gm daily of beer, wine, or spirits for ~6 years
15962601|NCT03169504|Other|Acupuncture|Feishu (BL13), Dazhui (DU14) and Fengmen (BL12) will be selected as main acupoints. There are four groups of acupoints: Taiyuan (LU9) and Zusanli (ST36) for Qi deficiency of the lung ZHEGN, Taiyuan (LU9), Pishu (BL20) and Zusanli (ST36) for Qi deficiency of the lung and spleen ZHEGN, Taiyuan (LU9), Shenshu (BL23) and Zusanli (ST36) for Qi deficiency of the lung and kidney ZHEGN, and Gaohuang (BL43), Shenshu (BL23), Taixi (KI3) and Guanyuan (RN4) for Qi and Yin deficiency of the lung and kidney ZHEGN. Besides, acupoints for specific symptoms will also be considered. Hwato Sterile Acupuncture Needles For Single Use (Hwato®, Suzhou Hua Tuo Medical Instruments Co., Ltd.) size in 0.30*25 mm, 0.30*40 mm or 0.30*50 mm will be used 3 times weekly for 12 weeks.
15962602|NCT03169504|Drug|Conventional drug|"Salbutamol Sulphate Inhalation Aerosol (Ventolin®, GlaxoSmithKline Australia Pty Ltd.), 100 μg/press, 200 press, 100 μg each time (when needed), no more than 8 press daily for 12 weeks.
~Tiotropium Bromide Powder for Inhalation (Spiriva®, Boehringer Ingelheim International GmbH), 18 μg/capsule, 10 capsule, 18 μg each time, once daily for 12 weeks.
~Fluticasone Propionate Powder for Inhalation (Seretide®, Laboratoire GlaxoSmithKline), 50ug/250μg/inhalation, 60 inhalations, 50ug/250μg each time, twice daily for 12 weeks."
15962603|NCT03169504|Other|Acupuncture plus conventional drug|Both acupuncture and conventional drug will be used for 12 weeks treatment.
15962604|NCT03169491|Device|Continuous positive airway pressure (CPAP)|CPAP dispositives will be used by the children in the study every night for two weeks. Devices AutoSet Spirit from ResMed.
15962639|NCT03169153|Device|Lotrafilcon B contact lenses|Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking
15962605|NCT03169478|Procedure|multiple myoma IUB dilatation group|A Foley catheter (size 8-12fr) will be prepared by cutting the excess catheter tip protruding beyond the balloon. Once the catheter has reached the fundus, 3-5mls of saline will be slowly introduced into the balloon under ultrasound guidance, in order to directly visualize the distention of the cavity and stretching and blunt dissection of any intrauterine adhesions, if present.
15962606|NCT03169465|Procedure|open approach|open excision of the bursa and deformity then debridement of Achilles tendon
15962607|NCT03169465|Procedure|endoscopic approach|excision of the bursa and deformity then debridement of Achilles tendon through endoscopy
15962608|NCT03169452|Device|Non-invasive mechanical ventilator|mechanical assisted breaths without the placement of an artificial way
15962609|NCT03169439|Procedure|Irreversible electroporation|minimal invasive ablative technique for tumors
15962610|NCT03169426|Drug|Beta Blockers Carvedilol Phosphate|Subjects are going to take Beta Blockers Carvedilol Phosphate (12.5mg once) before undergoing remote ischemic conditioning.
15962611|NCT03169413|Genetic|Human Leucocytic antigen typing and mutation of adenosine triphosphate sensitive K channel gene in diabetic patients diagnosed under the age of one year.|Gene study
15962612|NCT03169400|Device|Theranova dialyzer|Hemoadialysis
15962613|NCT03169387|Behavioral|Virtual Reality|For the VRG training, Microsoft's Xbox 360® will be used with Kinect™, which features an infrared camera sensor that recognizes user movements without a controller. The games used will be YourShape™(Fitness Evolved) and Dance Central 3™, which will be played for 25 minutes each; the former will be associated with the use of Velcro weights on the ankles and dumbbells in the hands to provide resistance.
15962614|NCT03169387|Behavioral|Conventional Training|treadmills (embreex) will be used to perform the aerobic training for a period of 30 minutes and free weights and weight training equipment for the resistance training, which will be carried out in 3 sets of 10 repetitions, with a recovery interval of 1 minute between sets.
15962615|NCT03169374|Device|Virtual Reality Technology|Patients in this arm will participate in virtual reality sessions planned for 5 minutes at a time, during which they are shown relaxing virtual environments.
15962616|NCT03169361|Drug|Ixazomib|Ixazomib capsules
15962617|NCT03169348|Drug|sofosbuvir daclatasvir|oral tablets
15962618|NCT03169348|Drug|Ledipasvir/sofosbuvir|oral tablets
15962619|NCT03169335|Drug|QL1101|targeted vascular endothelial growth factor (VEGF) monoclonal antibodies
15962620|NCT03169335|Drug|Avastin®|targeted vascular endothelial growth factor (VEGF) monoclonal antibodies
15962621|NCT03169335|Drug|Paclitaxel|175 mg/m2, IV (in the vein) following investigational product on day 1 of each 21 day cycle. Number of cycles 4-6.
15962622|NCT03169335|Drug|Carboplatin|AUC 5 IV, (in the vein) following paclitaxel on day 1 of each 21 day cycle. Number of cycles: 4-6.
15962623|NCT03169322|Procedure|SRP|patients having chronic periodontitis with mouth breathing habit will receive scaling and root planing
15962624|NCT03169309|Device|Brain Entrainment Technology|Brain Entrainment Technology (BET), also known as Binaural Beat Technology (BBT), is a sound technology where two slightly different tones are present to each ear and the brain produces a third tone. This third tone impacts the reticular activating system which alters the action potentials of the thalamus and cerebral cortex in turn changing the brain wave frequency to alter the state of consciousness of the listener.
15962625|NCT03169283|Other|Cereal with B glucan|A cereal high in viscous dietary fiber B glucan
15962626|NCT03169283|Other|Cereal without B glucan|Cereal without B glucan
15962627|NCT03169270|Other|Exercise training|All subjects performed a supervised 8-week, 5 days-week of endurance exercise training program in cycle-ergometer Each session included 5 minutes of warm-up and cool-down pedalling at 30% of peak work-rate (WR) and 50 minutes of interval training. The interval training combined 2 minutes of high-intensity pedalling and 3 minutes of active rest. Work-rate progress during the 8-week period was tailored on individual basis, according to subjects' symptoms, to maximize the training effect. During the first 2 weeks, high intensity pedalling interval was at least 70% of peak WR and active rest interval was at least 40% of peak WR. Thereafter, work-rate was increased by approximately 5% every week up to a maximum of 100% of peak WR during the last 2 weeks for the high intensity period and 50% of peak WR for the active rest. The cycling rate during the sessions was maintained at 60-70 rpm.
15962628|NCT03169257|Behavioral|diet plus physical activity|OB subjects will undergo an isocaloric Mediterranen balanced diet plus a daily aerobic training for at least 60 minutes. All the evaluations will be performed at baseline and after 6 and 12 months of this behavioral therapy. To assess food consumption, foods will be divided according to the classic basic food groups by the Italian Institute of Research on Food and Nutrition. Food frequencies questionnaires, validated for a wide range of ages, will be also completed by parents. Physical activity will be recorded by parents daily on a specific questionnaire.
15962629|NCT03169244|Drug|Bupropion|Bupropion XL will be initiated at 150 mg/d on Days 1-4 and increased to 300 mg/d for Days 5-84.
15962630|NCT03169244|Drug|Placebo Oral Tablet|Placebo will be initiated on Day 1 and continue throughout the course of the study.
15962631|NCT03169231|Biological|Longeveron Mesenchymal Stem Cells (LMSCs)|Intravenously delivered
15962632|NCT03169231|Other|Placebo|Intravenously delivered
15962633|NCT03169218|Other|Mirror therapy|The treatment proposed for the mirror group consisted of 8 weeks of treatment, performing a series of exercises 2 times a day / 4 times a week. The first 4 weeks the treatment was done in the hospital next to the physiotherapist for 2-3 days a week, and the next 4 weeks the patient performed the exercises following the same guidelines at home.
15962634|NCT03169218|Other|Placebo group|The treatment was the same than proposed in inference group but with a mirror covered to avoid the reflexion on the hand and looking at the hand that did not remain hidden.
15962635|NCT03169205|Other|observation registry|observation registry
15962636|NCT03169192|Drug|Zoledronic Acid|intravenous injections once every 3 months
15962637|NCT03169179|Behavioral|Fitbit and Bupa Boost app|Fitbit Charge 2™ wearable physical activity monitor and Bupa Boost health and wellbeing smartphone app. 12 weeks initial use (individual goal-setting in weeks 1-6 then social features of the app in weeks 7-12) followed by a further five months of optional use (as desired by the participant).
15962638|NCT03169166|Drug|Triptorelin|Triptorelin pre-filled syringes (Gonapeptyl 0.1mg; Ferring GmbH, Germany) will be administered subcutaneously in three repeated doses 12 hours apart
15962640|NCT03169153|Device|Senofilcon C contact lenses|Silicone hydrogel contact lenses used as per their Conformité Européenne (CE) marking
15962641|NCT03169140|Device|TheraBand Kinesiology Tape|A 20 cm strip of tape will be applied to each side of the low back directly over the erector spinae muscles at the site of pain. This tape will remain there, and be reapplied when necessary, for one week.
15962642|NCT03169140|Device|Biofreeze|The topical analgesic will be sprayed directly on top of the erector spinae and site of pain low back directly, from inferior to superior to inferior 4 times a day for one week.
15962643|NCT03169140|Behavioral|Advice|An at-home pain management care sheet, outlining standard care advice will be followed for at home pain management for one week.
15962644|NCT03169127|Drug|Ibuprofen 600 mg|After lower third molars surgeries, pharmacogenetic and clinical efficacy of Ibuprofen 600mg was study.
15962645|NCT03169114|Drug|Amikacin Injection|Participants allocated to Antibiotic Non-operative Management Strategy will be given intravenous Amikacin 15mg/kg/day divided over 3 doses for first 48 hours and followed by oral ciprofloxacin 500mg bd for 7 days
15962646|NCT03169114|Procedure|Appendicectomy|Patients allocated to Surgery Management Strategy will undergo appendicectomy
15962647|NCT03169101|Drug|Nicotine patch|"All participants will receive nicotine patches to aid in quitting smoking. TN is available over the counter and is very well tolerated. Participants will use the patch in a tapering fashion as recommended by the manufacturer. Participants who smoke 10 or more cigarettes per day will adhere to the following dosing guidelines: 21 mg for 4 weeks; 14 mg for 2 weeks and 7 mg for 2 weeks. Individuals who smoke between 5 and 9 cigarettes per day will follow a modified dosing regimen: 14 mg for 6 weeks and 7 mg for 2 weeks."
15962648|NCT03169101|Behavioral|Behavioral counseling|Participants will attend 6 counseling sessions and receive standard smoking cessation counseling (SC).
15962649|NCT03169088|Other|Coaching procedure|"In this study, the volunteers will be followed during one year.
~The wellbeing will be followed with :
~survey like FFQ, IPAQ, SF36, dietary habits.
~actimetry measurement
~one year follow-up of weight, waist measurement
~nutritional biomarkers"
15962650|NCT03169075|Behavioral|Supervised physical exercise programs|"A weekly supervised physical activity session of 60 min at the patient's home is planned for 3 months.
~These sessions will be supervised by an educator or physiotherapist trained, with respect to the pathology and the clinical study, specifically for this activity (Fédération Française Sport et Cancer) . The proposed exercises will be normalized and adapted to each patient's profile.
~Self reported questionnaires: FACT-F, FACT-G, EQ-5D, FAACT module AC/S, FACT-Gog, HADS, IPAQ, Evaluation by a coach VAE"
15962651|NCT03169075|Behavioral|Adapted physical activity|"Program based on the recommendations for performing a physical activity. A booklet containing physical activity recommendations will be given to the patients after randomization.
~The weekly sessions at the patients home for the experimental group (Program A) must begin as soon as possible within the 15 days after starting oral targeted therapy.
~Self reported questionnaires: FACT-F, FACT-G, EQ-5D, FAACT module AC/S, FACT-Gog, HADS, IPAQ"
15962652|NCT03169062|Device|Gated Stationary Chest Tomosynthesis|The technologist will comfortably position the patient laying face up on the imaging table. EKG leads will be placed in appropriate positions to derive an EKG signal. The EKG will be used to trigger the image collection. The subject will be asked to hold his or her breath for 25-30 seconds during the scan. Total patient preparation and imaging time should not exceed 20 minutes.
15962653|NCT03169049|Device|High-Frequency Stimulation|high-Frequency electrical stimulation over superficial ulnar and median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
15962654|NCT03169049|Device|sham Stimulation|Sham transcutaneous electrical stimulation over superficial ulnar and median nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
15962655|NCT03169023|Behavioral|ScaleDown|-Participants receives behavioral prompts and daily feedback by text messaging with motivational instructions for specific dietary and behavior modifications
15962656|NCT03169023|Behavioral|Enhanced Usual Care Packets|-From the American Cancer Society Website
15962657|NCT03169023|Other|12-Item Short Form Health Survey|-Measures functional health and well-being from the patient's perspective
15962658|NCT03169023|Other|International Physical Activity Questionnaire short form|-7 item scale that measures a range of physical activity from vigorous to sedentary over the last 7 days
15962659|NCT03169023|Other|Multidimensional Body Self Relations Questionnaire - Appearance Subscales|-Gold-standard for the assessment of body image attitudes and contains 34 items
15962660|NCT03169023|Other|Cancer-Related Body Image Scale|-13 item scale adapted from The Breast - impact of Treatment Scale, which assesses survivors' intrusive thoughts and avoidant behaviors with respect to their bodies since cancer treatment
15962661|NCT03169023|Other|Patient Health Questionnaire 9-Item Version|-Widely used measure that assesses mood, including an item that screens for suicidality
15962662|NCT03169023|Behavioral|iOTA|-Washington University based intervention
15962663|NCT03169010|Other|laboratory biomarker analysis|Laboratory results will be analysed to identify disease related biomarkers.
15962664|NCT03169010|Genetic|Genetic analysis|Gene sequencing results will be analysed to identify disease related mutations.
15962665|NCT03168997|Drug|Memantine Hydrochloride|Memantine Hydrochloride treatment according to clinical routine treatment
15962666|NCT03168984|Drug|UCB0942|"Pharmaceutical form: Film-coated tablet
~Route of administration: Oral use"
15962667|NCT03168984|Other|Placebo|"Pharmaceutical form: Film-coated tablet
~Route of administration: Oral use"
15962668|NCT03168971|Behavioral|Managing Anxiety from Cancer (MAC)|The intervention consists of seven telephone-administered sessions. Session topics include psychoeducation on anxiety, behavioral strategies for managing anxiety, cognitive restructuring, communication skills training, acceptance techniques, problem-solving strategies, and planning for future anxiety. Session content is tailored for older adults and caregivers of older adults with cancer.
15962669|NCT03168958|Drug|Methadone|Methadone will be provided at induction of anesthesia
15962670|NCT03168958|Drug|Saline|Saline will be administered at induction of anesthesia
15962671|NCT03168945|Other|GeneXpert MTB/RIF|Screening intervention: novel diagnostic for active case finding (GeneXpert MTB/RIF) for TB collected and performed at point-of-contact in a mobile van
15962710|NCT03168646|Procedure|arthroscopy and ulnar shortening osteotomy|wrist arthroscopy,debride debridement of Triangular fibrocartilage and shortening of the ulna by osteotomy and plate
15962672|NCT03168945|Other|Smear microscopy|Screening intervention: routine diagnostic test (smear microscopy) for active case finding for TB on sputum collected at point-of-contact in a mobile van but sent to laboratory
15962673|NCT03168919|Radiation|Fractionated Radiation|Standard of care fractionated radiation therapy will be given to the tumor.
15962674|NCT03168919|Drug|Temozolomide|Standard of care temozolomide will be given along with radiation therapy
15962675|NCT03168919|Device|MRI|Four MRI scan will be performed according to the protocol. The first one will be obtained before start of radiation therapy, the second MRI will be obtained after completion of 20 +/- 4 Gy, the third MRI will be obtained after completion of 40 +/- 4 Gy, and the final MRI will be obtained after completion of the radiation therapy.
15962676|NCT03168906|Drug|NEOD001|NEOD001 is a monoclonal antibody directed at soluble and insoluble light chain aggregates
15962677|NCT03168906|Drug|Placebo|Saline bag
15962678|NCT03168893|Device|Deep brain stimulation ON|Infinity model of deep brain stimulation is placed ( 2 brain elecrodes and subcutaneus generator ) under general anhestesia. The system is activated
15962679|NCT03168893|Device|Deep brain stimulation OFF|Infinity model of deep brain stimulation is placed ( 2 brain elecrodes and subcutaneus generator ) under general anhestesia. The system is not activated
15962680|NCT03168880|Drug|Paclitaxel + Carboplatin|Platinum based chemotherapy against the standard taxane based chemotherapy in the neo- adjuvant setting
15962681|NCT03168880|Drug|Paclitaxel only|
15962682|NCT03168867|Behavioral|The 3Ms Intervention|The 3 Ms is a brief e-health intervention delivered via an internet-based software application (CIAS) that incorporates principles of Motivational Interviewing. The goal of the 3 Ms intervention is to increase caregiver motivation to supervise children's daily diabetes care. The intervention consists of 3 brief sessions that are delivered at routine diabetes clinic appointments.
15962683|NCT03168854|Biological|Genetically-attenuated p52-/p36-/sap1- Plasmodium falciparum parasite (GAP3KO) strain|Genetically attenuated parasite created by triple deletion (GAP3KO) by deleting the P52, P36, and SAP1 genes in the NF54 wild-type (WT) strain of Plasmodium falciparum (Pf p52(-)/p36(-)/sap1(-) GAP).
15962684|NCT03168854|Other|Malaria challenge|Exposure to mosquitoes infected with P. falciparum.
15962685|NCT03168841|Drug|Efinaconazole Topical|Enrolled subjects will be dispensed medical for topical application, and followed for a period of 50 weeks.
15962686|NCT03168828|Drug|Trospium-Releasing Intravesical System (TAR-302-5018)|TAR-302-5018 is a passive, nonresorbable trospium-releasing intravesical system whose primary mode of action is the controlled release of trospium into the bladder over a 42-day period.
15962687|NCT03168815|Device|High Flow Nasal Cannula or Low Flow Nasal Cannula|HFNC vs LFNC
15962688|NCT03168802|Procedure|MRgFUS ablation|Focus ultrasound ablation therapy under MRI navigation for facet joint syndrome.
15962689|NCT03168802|Procedure|Radiofrequency ablation|Radiofrequency ablation therapy under C-arm navigation for facet joint syndrome.
15962690|NCT03168789|Behavioral|Tension Tamer (TT)|Tension Tamer is an app that provides training and motivation for breathing awareness meditation (BAM). The app also tracks heart rate values during each session by placing a finger tip over the rear camera.
15962691|NCT03168789|Behavioral|Lifestyle education program (SPCTL)|SPCTL group will use Runkeeper app to log physical activity. They will also receive text messages with short healthy lifestyle tips, and links to media with pamphlets or videos with more in-depth information.
15962692|NCT03168776|Device|BuMA Supreme DES|Implant BuMA Supreme stent only
15962693|NCT03168776|Device|Xience or Promus DES|Implant XIENCE family or Promus family only
15962694|NCT03168763|Behavioral|Video|Participants shown Video 1A or 1B, then shown Video 2A or 2B.
15962695|NCT03168763|Behavioral|Questionnaires|Questionnaires completed at baseline, after each video viewing, and at completion.
15962697|NCT03168737|Procedure|Computed Tomography|Undergo PET-CT scan
15962698|NCT03168737|Radiation|Fluorine F 18-fluoroazomycin Arabinoside|Given IV
15962699|NCT03168737|Procedure|Positron Emission Tomography|Undergo PET-CT scan
15962700|NCT03168724|Behavioral|GMT intervention|
15962701|NCT03168711|Drug|Inosine|Subjects on inosine will receive 1-6 capsules a day of 500 mg inosine titrated to target urate levels of 7 - 8 mg/dL.
15962702|NCT03168711|Drug|Placebo|Subjects on placebo will receive 1-6 capsules a day of 500 mg placebo (sugar pill) titrated to target urate levels of 7 - 8 mg/dL.
15962703|NCT03168698|Drug|Carbetocin|Patient is given carbetocin (20 or 100 mcg) intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby.
15962704|NCT03168698|Drug|Oxytocin|Patient is given oxytocin (0.5 or 5 IU) intravenously over 1 minute, immediately upon delivery of the anterior shoulder of the baby.
15962705|NCT03168685|Device|SureSource Engage application|"Eligible patients who choose to participate in the study will be asked to wear an actigraphy device [ActiGraph GT9X Link Actigraph Link] on their wrist continuously during both 4-week study phases.
~The ActiGraph Link is a small (3.5 X 3.5 X 1 cm) wristwatch like device weighing approximately 14 grams that measures indicators of the wearer's activity and sleep patterns, including: acceleration, energy expenditure, steps, basal metabolic rate, activity intensity, sleep time, sleep efficiency, sleep latency, and body position.
~The application being utilized is SureSource Engage application from Clinical Ink. The application is compatible to most Android and iOS devices.
~Participants will also use a basic Bluetooth-enabled weight scale that syncs with the application."
15962706|NCT03168672|Device|Global ICON|The study device is the GLOBAL ICON stemless humeral component, consisting of the Anchor Plate and Humeral Head.
15962707|NCT03168659|Device|HeartLight|HeartLight Endoscopic Ablation System
15962708|NCT03168659|Procedure|Ablation|Pulmonary vein isolation ablation
15962709|NCT03168646|Procedure|wafer procedure|wrist arthroscopy and debridement of Triangular fibrocartilage and shortening of the head ulna by burr
15962711|NCT03168633|Behavioral|web-based DM2 information pages|"Each email will include information on one of the following topics:
~The importance of physical activity
~Correct nutrition
~The importance of adhering to medication regimens.
~Emails will be either positive (e.g., the importance of good nutrition, and what constitutes good nutrition) or negative (e.g., the risks of not adhering to medications).
~The information will be provided by different approaches: medical research results, practical tips, patient testimonies.…"
15962712|NCT03168620|Procedure|Restoration|
15962713|NCT03168607|Drug|FOLFIRI Protocol|Irinotecan：180mg/m2 ，iv drip for 90min d1, 5-FU 2400mg/m2, iv drip for 46h, 5-FU 400mg/m2 iv d1, CF 200mg/m2 iv drip for 2h d1, q2W
15962714|NCT03168594|Drug|irinotecan cisplatin|Irinotecan：60mg/m2 ，iv drip for 90min，d1,8 q3W cisplatin: 60mg/m2 ，iv drip for 120min，d1 q3W
15962715|NCT03168594|Drug|Etoposide cisplatin|Etoposide：100mg/m2 ，iv drip for 60min，d1-3 q3W cisplatin: 75mg/m2 ，iv drip for 120min，d1 q3W
15962716|NCT03168581|Drug|CN-105|Patients with supratentorial intracerebral hemorrhage (ICH) will be evaluated for eligibility within 12 hours of symptom onset. Eligible participants will receive CN-105 administered intravenously (IV) for a 30 -minute infusion every 6 hours for up to a maximum of 3 days (13 doses) or until discharge (if earlier than 3 days)
15962717|NCT03168568|Drug|Valsartan/Sacubitril or placebo|tablet (double dummy)
15962718|NCT03168568|Drug|Valsartan or placebo|tablet (double dummy)
15962719|NCT03168555|Drug|chenodeoxycholic acid|1250 mg CDCA is given with a study meal
15962720|NCT03168542|Device|JJVC Fitting Guides|Subjects who are habitual soft spherical or toric contact lens wearers, at least 40 years of age and no more than 70 years of age, will be fitted, according to the fitting guide, with either the Multifocal Contact Lens or an Investigational Toric Multifocal Contact Lens if refractive cylinder power of the eye is between -1.00 to -1.50. The Intervention is approximately 30-90 minutes during a 1 day visit.
15962721|NCT03168529|Drug|Ivabradine|At discharge from the observation unit, subjects will receive a pill bottle containing oral capsules containing active drug to take at home. This arm will require the subject to take the study medication BID for the duration of the study period. Neither study team nor subject will know if the pill bottle contains active drug or placebo.
15962722|NCT03168529|Drug|Placebo|At discharge from the observation unit, subjects will receive a pill bottle containing oral capsules not containing active drug to take at home. This arm will require the subject to take the study medication BID for the duration of the study period. Neither study team nor subject will know if the pill bottle contains active drug or placebo.
15962723|NCT03168516|Device|closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C)|Application of FiO2-C (provided by standard infant ventilators) in addition to manual adjustments of the inspired oxygen fraction (FiO2) during mechanical ventilation and continuous positive airway pressure (CPAP) in ELGANs at least up to 32weeks PMA according to a standardized protocol
15962724|NCT03168503|Dietary Supplement|LGG+Promitor™|synbiotic
15962725|NCT03168503|Dietary Supplement|Promitor™|Soluble Corn Fiber
15962726|NCT03168503|Dietary Supplement|LGG-PB12+Promitor™|synbiotic
15962727|NCT03168503|Dietary Supplement|Maltodextrin|Control
15962728|NCT03168490|Dietary Supplement|Gluten Friendly bread|parallel study
15962729|NCT03168477|Other|dry needling|Dry needling to the supraspinatus (proximal/distal teno-osseus junction and musculotendinous junction under acromion process), deltoid muscle, upper trapezius muscle and levator scapulae muscle on the painful side. Clinicians may also needle the terres major, infraspinatous, rhomboids and thoracic paraspinals, as needed. Up to 12 treatment sessions over 6 weeks.
15962730|NCT03168477|Other|spinal manipulation|HVLA thrust manipulation to cervical, thoracic and/or upper rib articulation (R1-R3).
15962731|NCT03168477|Other|mobilization|Impairment-based mobilization targeting the muscles, scapulae and joint capsule of the painful shoulder. Up to 12 treatment sessions over 6 weeks.
15962732|NCT03168477|Other|exercise|Impairment-based exercise targeting the muscles, scapulae and joint capsule of the painful shoulder. Up to 12 treatment sessions over 6 weeks.
15962733|NCT03168477|Other|modalities|Interferential electrotherapy targeting the muscles, scapulae and joint capsule of the painful shoulder. Up to 12 treatment sessions over 6 weeks.
15962734|NCT03168464|Drug|Ipilimumab|Ipilimumab (3mg/kg) is given concurrently (+/- 24hrs from first RT dose) with radiation therapy on Day 1 of the study. On day 22 the combined treatment of ipilimumab plus nivolumab will start (nivolumab 240mg q 2 weeks, ipilimumab 1mg/kg q 6 weeks), and administered until evidence of progression.
15962735|NCT03168464|Drug|Nivolumab|On day 22 the combined treatment of ipilimumab plus nivolumab will start (nivolumab 240mg q 2 weeks, ipilimumab 1mg/kg q 6 weeks), and administered until evidence of progression.
15962736|NCT03168464|Radiation|Radiation therapy|Ipilimumab (3mg/kg) is given concurrently (+/- 24hrs from first RT dose) with radiation therapy on Day 1 of the study.
15962737|NCT03168451|Behavioral|Culturally Tailored Text Messages|Members of the intervention group receive culturally tailored messages on the following schedule: 4 messages per day for 1 week prior to target quit date, 4 messages per day for 4 weeks following target quit date, 3 messages per week for 20 weeks following weeks.
15962738|NCT03168438|Drug|Letetresgene autoleucel|Letetresgene autoleucel (GSK3377794) as an IV infusion
15962739|NCT03168438|Drug|Letetresgene autoleucel with pembrolizumab|Letetresgene autoleucel (GSK3377794) as an IV infusion, followed by pembrolizumab every 3 weeks
15962740|NCT03168438|Drug|Fludarabine|Fludarabine will be used as lymphodepleting chemotherapy and will be administered via IV route.
15962741|NCT03168438|Drug|Cyclophosphamide|Cyclophosphamide will be used as lymphodepleting chemotherapy and will be administered via IV route.
15962742|NCT03168438|Drug|Pembrolizumab|Pembrolizumab is available as an IV infusion
15962743|NCT03168425|Other|Tailored prescription|Participants will be prescribed an opioid tablet number based on a formula derived from inpatient opioid use
15962744|NCT03168425|Other|Control|Participants will be prescribed 30 tablets of oxycodone 5mg
15962745|NCT03168412|Biological|Recombinant Hepatitis E Vaccine (Escherichia Coli)|Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 7, 21 days.
15962746|NCT03168412|Biological|Recombinant Hepatitis E Vaccine (Escherichia Coli)|Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
15962747|NCT03168399|Dietary Supplement|PKU Explore|PKU Explore is an unflavoured, powdered, phenylalanine-free, protein substitute, containing essential and non-essential amino acids, carbohydrate, sugar, vitamins, minerals, trace elements and the long chain polyunsaturated fatty acids (LCPs); arachidonic acid (AA) and docosahexaenoic acid (DHA).
15962748|NCT03168386|Procedure|Intensive motor rehabilitation|Intensive motor rehabilitation during subacute stroke phase
15962749|NCT03168373|Procedure|language rehabilitation therapy|language therapy is language rehabilitation by language therapist during subacute phase in stroke patients
15962750|NCT03168360|Procedure|Cognitive rehabilitation|Intensive cognitive rehabilitation by cognitive therapist for 1 hours on every working day during subacute stroke phase
15962755|NCT03168334|Drug|IDP-123 Lotion|Tazarotene 0.045% Lotion
15962756|NCT03168334|Drug|IDP-123 Vehicle Lotion|Vehicle Lotion
15962757|NCT03168321|Drug|IDP-123 Lotion|Tazarotene 0.045% Lotion
15962758|NCT03168321|Drug|IDP-123 Vehicle Lotion|Vehicle Lotion
15962759|NCT03168308|Drug|Sugammadex|Sugammadex 2 mg/kg
15962760|NCT03168308|Drug|Neostigmine w/ Glycopyrrolate|Neostigmine 50 mcg/kg, maximum 5 mg Glycopyrrolate, 8 mcg/kg, maximum 1 mg
15962761|NCT03168295|Drug|Dapagliflozin 10mg then Placebo Oral Tablet|SGLT2 inhibitor - Dapagliflozin then Placebo
15962762|NCT03168295|Drug|Placebo Oral Tablet then Dapagliflozin 10mg|Placebo then SGLT2 inhibitor - Dapagliflozin
15962763|NCT03168269|Diagnostic Test|Coronary Computed Tomographic Angiography (CCTA)|CCTA of coronary arteries
15962764|NCT03168256|Drug|CF101 2mg|CF101 tablets, 2mg BID for 16 weeks
15962765|NCT03168256|Drug|CF101 3mg|CF101 tablets, 3mg BID for 16 weeks
15962766|NCT03168256|Drug|Apremilast 30mg|Apremilast tablets, 30mg BID for 16 weeks
15962767|NCT03168256|Drug|Placebo Oral Tablet|Placebo tablets, BID for 16 weeks
15962768|NCT03168243|Dietary Supplement|High Energy High Protein Tube Feed|Following a 3 day baseline period all patients will receive the high energy, high protein tube feed for a period of 4 weeks (28 days).
15962769|NCT03168230|Procedure|Portal vein embolization (PVE)|"Portal vein embolization (PVE) is a procedure that induces regrowth on one side of the liver in advance of a planned hepatic resection on the other side. The procedure is frequently used in primary liver cancer (hepatocellular carcinoma) and colorectal liver metastases.
~An interventional radiologist will place a needle percutaneously (through the skin) into the liver and identify the blood vessel on the side where the largest part of the tumor is being supplied. Tiny microspheres are then infused into the portal vein which supplies blood to the area, embolizing it by cutting off its blood supply.
~This blockade of the blood supply induces the other side of the liver to regrow. After several weeks, the non-embolized side has grown enough so that surgery is now a viable option.
~Source of this information : http://general.surgery.ucsf.edu/conditions--procedures/portal-vein-embolization-(pve).aspx"
15962770|NCT03168204|Behavioral|Tailored care and support|Offering tailored care and support whereby the competences, strengths and resources of the older person are taken into account.The intervention will be an enhancement of usual care and will depend on the availability of the municipality, and could be formal (i.e., home care) or informal (e.g. activities of an older adult's association).
15962771|NCT03168191|Drug|Nicotine|Participants will receive low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)
15962772|NCT03168191|Other|Experimental Flavor|Experimental fruit flavored e-cigarette for lab session
15962773|NCT03168191|Other|Menthol Flavor|Menthol flavored e-cigarette for lab session
15962774|NCT03168178|Drug|Standard Antibiotic Treatment|"Participants randomized to this intervention will receive standard antibiotic treatment.
~The placenta will be submitted for pathologic exam after delivery and investigators will collect maternal and neonatal outcomes"
15962775|NCT03168178|Other|No Antibiotic Treatment|Participant randomized to this arm of the study will not receive antibiotics. The placenta will be submitted for pathologic exam after delivery and investigators will collect maternal and neonatal outcomes
15962776|NCT03168165|Other|Pain neuroscience education training|PNE training will consist of 6 weeks online training followed by one day training session.
15962777|NCT03168152|Radiation|Microwave Ablation (MWA)|MWA will typically be administered in one ablation session during which time up to 2 tumors are treated.
15962778|NCT03168152|Radiation|Stereotactic Body Radiation Therapy (SBRT)|SBRT will be administered in five fractions of up to 10 Gy per fraction. SBRT will be administered 5-15 days per tumor.
15962779|NCT03168139|Drug|Olaptesed pegol - Monotherapy|"Monotherapy (MT) period:
~Treatment with 300 mg olaptesed pegol only, weekly on MT D1 and MT D4 for up to 2 weeks"
15962780|NCT03168139|Drug|Olaptesed pegol + Pembrolizumab - Combination Therapy|"Combination therapy (CT) period:
~Treatment with 300 mg olaptesed pegol in combination with 200 mg pembrolizumab every three weeks (Q3W) until progressive disease or limiting toxicity, for a maximum of 24 months in total"
15962781|NCT03168126|Device|Pro-AQT|Use of the device for advanced hemodynamic monitoring
15962782|NCT03168100|Drug|Elotuzumab|administered via IV infusion
15962783|NCT03168100|Drug|Lenalidomide|taken by mouth
15962784|NCT03168100|Drug|Dexamethasone|taken by mouth
15962785|NCT03168100|Drug|Bortezomib|administered as a subcutaneous injection
15962786|NCT03168087|Other|Plasmalyte-148|Venous blood is taken from 12 healthy volunteers and divided into four specimen bottles, which were diluted with different levels (0%, 20%, 40%, and 60%) using a plasmalyte-148 solution.
15962787|NCT03168074|Drug|lenvatinib|Eligible patients will be treated with approximately 2 weeks of single agent lenvatinib (range 10-28 days, depending on the date of breast cancer surgery; last dose of lenvatinib to be administered no later than 48 hours before surgery in patients who are planned to receive ≤14 days lenvatinib, and no later than 120 hours before surgery in patients who are planned to receive 15-28 days lenvatinib).Tissue sections from the pre-treatment and post-treatment tumor will be collected for biomarker analysis. Pre- and post-treatment ultrasound will be used to document the size of the target lesions.
15962788|NCT03168061|Drug|NC 6300|Part 1: NC-6300 at escalating doses starting at a fixed dose Part 2: NC-6300 at the RPII dose
15962789|NCT03168048|Other|mobile application|Oncologic therapy support by means of a mobile application
15962790|NCT03168035|Drug|NC-4016|"Dose Escalation Group Starting Dose: 15 mg/m2 by vein on Day 1 of a 21 Day cycle.
~Dose Expansion Group Starting Dose: Maximum tolerated dose from Dose Escalation Group."
15962791|NCT03168022|Drug|Treatment A|1 x TNX-102 SL 2.8 mg yellow tablet (commercial manufacturer) to be held under the tongue until dissolved.
15962792|NCT03168022|Drug|Treatment B|1 x TNX-102 SL 2.8 mg white tablet (original manufacturer) to be held under the tongue until dissolved.
15962793|NCT03168009|Procedure|Bariatric Surgery|Patients will undergo bariatric surgery as routinely scheduled. The type of bariatric procedure will be suggested by the surgeon based on clinical considerations.
15962794|NCT03167996|Behavioral|Use of HealthPals (Telemedicine supported by digital health platform)|"HealthPals is a smartphone-based chronic disease management mobile application. It uses the mobile health capabilities of smartphones to provide a secure communication portal for patients with their Care Teams to help achieve cardiovascular risk reduction through a digital health coach-based coaching for lifestyle and medication compliance.
~The HealthPals app was developed by HealthPals, Inc."
15962795|NCT03167970|Device|Pill cam|Patient is asked to swallow the esophageal capsule.
15962796|NCT03167970|Other|EGD|Patient will undergo standard EGD
15962797|NCT03167957|Drug|Oral Encochleated Amphotericin B (CAMB)|Lipid-crystal nano-particle formulation amphotericin B
15962798|NCT03167957|Drug|Oral Encochleated Amphotericin B (CAMB)|Lipid-crystal nano-particle formulation amphotericin B
15962799|NCT03167944|Device|Low thermal electrosurgery system|PEAK Plasmablade
15962800|NCT03167944|Device|Conventional Electrocautery|Conventional Electrocautery
15962801|NCT03167931|Other|MRI + transcranial Magnetic Stimulation|Healthy subjects undergo 2 sessions of MRI + transcranial Magnetic Stimulation + transcranial electric stimulation + electroencephalogram. The 2 sessions are performed with an interval of 3 to 7 days.
15962802|NCT03167931|Other|transcranial electric stimulation + electroencephalogram|Healthy subjects undergo 2 sessions of MRI + transcranial Magnetic Stimulation + transcranial electric stimulation + electroencephalogram. The 2 sessions are performed with an interval of 3 to 7 days.
15962803|NCT03167918|Drug|Calcium Dobesilate|gave each patient 0.5 g bid，
15962804|NCT03167918|Drug|Xuefuzhuyu Decoction|gave each patient100 ml bid，po
15962805|NCT03167918|Drug|Xuefuzhuyu Decoction & Calcium dobesilate|gave each patient Calcium dobesilate 0.5 g bid，po and Xuefuzhuyu Decoction 100 ml bid，po
15962806|NCT03167918|Drug|metformin|gave each patient 1000 mg, bid, PO
15962807|NCT03167918|Drug|Mecobalamin Tablets|gave each patient 0.5 mg bid, PO
15962808|NCT03167905|Device|Epidural delivery system|Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.
15962809|NCT03167905|Drug|Entonox|Entonox will be given upon request in non-epidural group.
15962810|NCT03167905|Drug|Meperidine|Intramuscular pethidine (75mg/1.5ml) will be given upon request in non-epidural group.
15962811|NCT03167905|Drug|Ultiva|Intravenous patient controlled remifentanil (20-40mcg/ml) is only given when the patient rejects or cannot receive pethidine and entonox in non-epidural group..
15962812|NCT03167905|Drug|Fentanyl|Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.
15962813|NCT03167905|Drug|Ropivacaine|Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.
15962814|NCT03167892|Device|Oral screen|Oral screen training three times per day with an effective training time of 1.5 minutes, for 3 mo
15962815|NCT03167879|Behavioral|safer conception counseling|Multi-component counseling to help HIV-affected couples to make an informed decision about childbearing, and to provide counseling to use contraception or safer conception methods, depending on whether the couples chooses to seek or prevent pregnancy after initial consultation.
15962816|NCT03167866|Behavioral|motivational SMS|the participant receives a weekly text message that is aimed to increase motivation
15962817|NCT03167866|Behavioral|informational SMS|the participant a weekly text message that is provides information on improving lifestyle
15962818|NCT03167853|Biological|humanized anti-PD-1 monoclonal antibody|humanized anti-PD-1 monoclonal antibody(JS001) is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with th combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activitation of lymphocytes and elimination of malignancy theoretically.
15962819|NCT03167840|Behavioral|Physical and Cognitive Training|Physical Exercise and Cognitive Training
15962820|NCT03167840|Behavioral|Physical Training|Physical training alone
15962821|NCT03167840|Behavioral|Cognitive training|Cognitive training alone
15962822|NCT03167827|Other|Exercise|The training program consisted of aerobic and resisted combined physical exercises performed during 10 weeks, three times weekly with 45 minutes sessions: 5 minutes of warm-up on treadmill, 20 minutes of aerobic exercises and 20 minutes of resistance exercises.
15962823|NCT03167827|Other|isoflavone|Daily supplementation in 1 capsule per day of 100mg of isoflavones (containing 3.3% genistein, 93.5% dadzein and 3.2% glycitein).
15962824|NCT03167827|Other|placebo|Daily supplementation in 1 capsule per day containing starch of corn.
15962825|NCT03167814|Dietary Supplement|Diet group|In the diet, there is no long-chain triglycerides. Fat and protein needs are met with adding medium-chain-fat acid as oil and protein supplements to the diet. Diet has been constructed together with clinical nutrition specialist.
15962826|NCT03167788|Device|rejuvesol Solution|The rejuvenation process involves incubation of stored red cells with a rejuvenating solution, rejuvesol Red Blood Cell Processing Solution (rejuvesol® Solution), Citra labs, MA, a Zimmer Biomet Company, IN, USA) which restores red cell adenosine triphosphate (ATP), 2,3-DPG (diphosphoglycerate), oxygen transfer characteristics and rheology. Post rejuvenation red cells are washed to remove the rejuvesol Solution, and cells are re-suspended in additive solution for transfusion.
15962827|NCT03167788|Other|Standard Care|Allogeneic red cells, harvested in citrate-phosphate-dextrose (CPD), leucocyte depleted, saline-adenine-glucose-mannitol (SAGM) stored red cell units, issued by National Health Service Blood & Transplant (NHSBT) will be administered to cardiac surgery patients as per standard practice, and according to established unit protocols.
15962828|NCT03167775|Drug|Elemene Injection/Elemene Oral Emulusion|
15962829|NCT03167762|Device|Fluorescence and thermal imaging|Two cameras used to take images of the skin. One, to measure the fluorescence from the photosensitiser, and the second to measure the surface temperature of the skin
15962830|NCT03167749|Diagnostic Test|Laboratory test|Semen analysis and reproductive hormonal assay (free and total testosterone, luteinizing hormone, follicle-stimulating hormone , estradiol and prolactin hormone) for both patients and control group
15962831|NCT03167736|Other|electric dry needling, manipulation|HVLA thrust manipulation to lumbar spine. Dry needling to lumbar/sacral paraspinal muscles and gluteus medium/minimus muscles. Treatment may include dry needling of the piriformis muscle, quadrates lumborum muscle and perineurial needling of sciatic/tibial nerve. Up to 12 treatment sessions over 6 weeks.
15962832|NCT03167736|Other|conventional physical therapy|Impairment-based manual therapy, stretching, strengthening and electrothermal modalities targeting the lumbar/sacral spine and hips. Up to 12 treatment sessions over 6 weeks.
15962833|NCT03167723|Device|Chest tube placement|Placing tube thoracostomy for hemothorax or hemopneumothorax utilizing maximal barrier precautions.
15962834|NCT03167710|Other|Dry Needling, manipulation, stretching|HVLA thrust manipulation to elbow, wrist and spine (C5-C6). Dry needling to wrist extensor muscles on the dorsal forearm, proximal and distal of the lateral epicondyle. Up to 8 treatment sessions over 4 weeks.
15962835|NCT03167710|Other|manual therapy, exercise, ultrasound|Impairment-based manual therapy, exercise and ultrasound targeting the wrist extensors on the dorsal forearm, proximal and distal of the lateral epicondyle. Up to 8 treatment sessions over 4 weeks.
15962836|NCT03167697|Dietary Supplement|Synergy|Small serving (x1 33 g serving daily) of the new phenylalanine-free protein substitute made up with 100mL of water daily (28 days).
15962837|NCT03167697|Other|Routine|Patients will continue their usual dietary and/or protein substitute regimen (28 days).
15962838|NCT03167684|Device|Oral appliance therapy|Fitted oral appliance
15962839|NCT03167671|Device|AposTherapy|AposTherapy® is a home-based exercise program utilizing footwear that causes exercise with normal daily activity
15962840|NCT03167671|Other|Traditional Physical Therapy|Up to 20 sessions of traditional physical therapy
15962841|NCT03167658|Behavioral|Workplace wellness program|Multi-prong workplace wellness program, with components such as nutrition counseling, fitness challenges, and stress management workshops, including supports and incentives.
15962842|NCT03167645|Drug|Human albumin|Substitution according to pre-specified dosage
15962843|NCT03167619|Drug|Olaparib Oral Product|olaparib 300mg twice daily
15962844|NCT03167619|Drug|Olaparib Oral Product in combination with Durvalumab|olaparib 300mg twice daily plus intravenous durvalumab every 28 days
15962845|NCT03167606|Behavioral|MyPEEPS Mobile|Mobile technology to deliver HIV prevention information specifically developed for at-risk YMSM.
15962846|NCT03167593|Dietary Supplement|Lactobacillus coryniformis K8 CECT5711|Lactobacillus coryniformis CECT5711
15962847|NCT03167593|Other|Control placebo|Maltodextrin
15962848|NCT03167580|Procedure|restricted PEEP|Patients are randomized and ventilated with restricted PEEP (the lowest possible PEEP level, 0 - 5 cm H2O)
15962849|NCT03167580|Procedure|liberal PEEP|Patients are randomized and ventilated with liberal PEEP (the median PEEP level used in the Netherlands, 8 cm H2O)
15962850|NCT03167567|Behavioral|Presence of a medical clown during labor|Presence of a medical clown during labor
15962851|NCT03167554|Other|Sham comparator|The electrolysis technique was simulated to be delivered. The guide tube of the needle contacted with the skin, located on the painful area, and the device remained switched on to simulate its functioning.
15962852|NCT03167554|Other|Experimental group 1|Percutaneous Therapeutic Electrolysis (EPTE®) with monopolar needle, 330 microamps, 1 min 20 sec.
15962853|NCT03167554|Other|Experimental group 2|Percutaneous Therapeutic Electrolysis (EPTE®) with bipolar needle, 120 microamps, 1 min 20 sec.
15962854|NCT03167541|Drug|Test|RB naproxen sodium tablets (2x220mg)
15962855|NCT03167541|Drug|Reference|Aleve naproxen sodium tablets (2x220mg)
15962856|NCT03167528|Behavioral|Relaxation|Relaxation
15962857|NCT03167528|Behavioral|Hypnosis|Hypnosis
15962858|NCT03167528|Behavioral|Holistic gymnastics|holistic gymnastics
15962859|NCT03167528|Device|Transcutaneous electrical nerve stimulation (TENS)|TENS
15962860|NCT03167528|Behavioral|Sophrology|Sophrology
15962861|NCT03167515|Device|074-6751 Lotion|Apply lotion once in the morning and once in the evening daily at approximately the same time every day with 12 hours between doses. Apply the lotion only to the active psoriatic lesions, as instructed by your study doctor.
15962862|NCT03167502|Other|eccentric work|patient will follow 2 eccentric trainings per week during 6 weeks
15962863|NCT03167502|Other|concentric work|patient will follow 2 concentric trainings per week during 6 weeks
15962864|NCT03167489|Behavioral|Lifestyle Plus Emotional Regulation|Group intervention over 5 months, integrating the Mediterranean Diet into a lifestyle intervention and emotional regulation skills.
15962865|NCT03167463|Procedure|flap|Repair choanal atresia with using flap during surgery
15962868|NCT03167424|Device|Treatment of restenosis|Treatment of in-stent restenosis
15962869|NCT03167411|Drug|Bexagliflozin|Bexagliflozin tablets, 20 mg
15962871|NCT03167398|Biological|Fecal Microbiota Transplantation|Patients able to swallow will be given capsulized FMT using 15 capsules a day for two consecutive days. Patients will be treated concomitantly with omeprazole 20mg once in the evening before FMT and daily for the next 2 days.
15962872|NCT03167385|Drug|Apatinib Mesylate|oral intake of Apatinib Mesylate 500mg once a day until progression of diesase or severe adverse effect
15962873|NCT03167372|Other|Litebook® Advantage|Standard system light therapy device used in an investigation to assess the feasibility of conducting a randomized trial design. The lightbox produces different wavelengths of the light identical to the peak wavelengths of the sun - bright white, dim white and red light.
15962874|NCT03167372|Other|Fitbit Flex2 TM|Standard system activity and sleep tracker
15962875|NCT03167359|Radiation|Hypofractionated Simultaneous Integrated Boost Radiotherapy|Participants will receive radiotherapy treatments to the whole breast or chest wall to a dose of 2.66 Gy per day x 15 fractions simultaneously with a boost treatment. The boost treatment will be given on the same days as the whole breast treatment. The lumpectomy cavity + scar (in lumpectomy patients) or chest wall scar (mastectomy patients) will receive 0.54 Gy per day x 15 fractions.
15962876|NCT03167333|Drug|platelet rich plasma|The amount of PPR was about 4-5 cc
15962877|NCT03167333|Drug|Hyaluronic acid|HA was 2.5cc
15962878|NCT03167307|Drug|Omega 3 fatty acid|Omega-3 fatty acids in addition to standard treatment for depression in children and adolescents according to the German S3 Guidelines
15962879|NCT03167307|Drug|Placebo oil|medium chain triglycerides in addition to standard treatment for depression in children and adolescents according to the German S3 Guidelines
15962880|NCT03167294|Device|AquaBeam System|Aquablation
15962881|NCT03167281|Combination Product|early tPA and DNase|Early addition of tPA and DNase (immediately at chest tube placement) versus later (24-48 hours) after chest tube placement.
15962882|NCT03167268|Drug|Lycopene|
15962883|NCT03167268|Other|Placebo|
15962884|NCT03167255|Drug|NS-065/NCNP-01|Received during weekly intravenous infusions
15962885|NCT03167242|Drug|KAF156 and LUM-SDF|Exploration of different dose combinations of KAF156 and LUM-SDF. In Part B, up to three arms will be repeated in children 2 to 12 Years to confirm safety and efficacy from Part A.
15962886|NCT03167242|Drug|Coartem|Control arm
15962887|NCT03167216|Drug|Cromolyn Sodium|Mast cell stabilizer
15962888|NCT03167216|Drug|Cetirizine Hydrochloride|Histamine receptor antagonist
15962889|NCT03167203|Biological|Human Embryonic Stem Cell-Derived Retinal Pigment Epithelial Cells|Participants who have received sub-retinal transplant of hESC-RPE cells in an AIRM sponsored clinical trial
15962890|NCT03167190|Procedure|Point-of-care ultrasound|A point-of-care ultrasound machine will be utilized to identify and mark midline and the interspinous space based on visualization of spinous processes.
15962891|NCT03167190|Procedure|Traditional Landmark-based Lumbar Puncture|Palpation of anatomical landmarks to identify midline and interspinous space
15962892|NCT03167177|Biological|Avelumab|Fully human anti-PD-L1 IgG1 lambda monoclonal antibody
15962893|NCT03167177|Biological|Bevacizumab|Recombinant human anti-VEGF IgG1 monoclonal antibody
15962894|NCT03167177|Drug|Capecitabine|5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine
15962895|NCT03167177|Drug|Cisplatin|(SP-4-2)-diamminedichloroplatinum(II)
15962896|NCT03167177|Drug|Cyclophosphamide|2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
15962897|NCT03167177|Drug|5-fluorouracil|5-fluoro-2,4 (1H,3H)-pyrimidinedione
15962898|NCT03167177|Drug|Leucovorin|Calcium N-[p-[[[(6RS)-2-amino-5-formyl-5,6,7,8-tetrahydro-4-hydroxy-6- pteridinyl]methyl]amino]benzoyl]-L-glutamate (1:1)
15962899|NCT03167177|Drug|nab-paclitaxel|5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine
15962900|NCT03167177|Biological|Nivolumab|Recombinant human anti-PD-1 IgG4 monoclonal antibody
15962901|NCT03167177|Drug|omega-3-acid ethyl esters|Omega-3-acid ethyl esters
15962902|NCT03167177|Radiation|Stereotactic Body Radiation Therapy|radiation
15962903|NCT03167177|Biological|ALT-803|Recombinant human super agonist interleukin-15 (IL-15) complex
15962904|NCT03167177|Biological|ETBX-011|Ad5 [E1-, E2b-]-CEA
15962905|NCT03167177|Biological|ETBX-051|Ad5 [E1-, E2b-]-Brachyury
15962906|NCT03167177|Biological|ETBX-061|Ad5 [E1-, E2b-]-MUC1
15962907|NCT03167177|Biological|GI-6207|Heat-killed S. cerevisiae yeast expressing CEA
15962908|NCT03167177|Biological|GI-6301|Heat-killed S. cerevisiae yeast expressing the human Brachyury (hBrachyury) oncoprotein
15962909|NCT03167177|Biological|haNK|NK-92 [CD16.158V, ER IL-2] (high-affinity activated Natural Killer cells)
15962910|NCT03167164|Biological|Avelumab|Fully human anti-PD-L1 IgG1 lambda monoclonal antibody
15962911|NCT03167164|Biological|Bevacizumab|Recombinant human anti-VEGF IgG1 monoclonal antibody
15962912|NCT03167164|Drug|Capecitabine|5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine
15962913|NCT03167164|Drug|Cisplatin|(SP-4-2)-diamminedichloroplatinum(II)
15962914|NCT03167164|Drug|Cyclophosphamide|2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
15962915|NCT03167164|Drug|5-fluorouracil|5-fluoro-2,4 (1H,3H)-pyrimidinedione
15962916|NCT03167164|Drug|Leucovorin|Calcium N-[p-[[[(6RS)-2-amino-5-formyl-5,6,7,8-tetrahydro-4-hydroxy-6-pteridinyl]methyl]amino]benzoyl]-L-glutamate (1:1)
15962917|NCT03167164|Drug|nab-Paclitaxel|5β,20-Epoxy-1,2α,4,7β,10β,13α-hexahydroxytax-11-en-9-one 4,10-diacetate 2-benzoate 13-ester with (2R,3S)-N-benzoyl-3-phenylisoserine
15962918|NCT03167164|Drug|omega-3-acid ethyl esters|Omega-3-acid ethyl esters
15962919|NCT03167164|Radiation|Stereotactic Body Radiation Therapy|radiation
15962920|NCT03167164|Biological|ALT-803|Recombinant human super agonist interleukin-15 (IL-15) complex
15962921|NCT03167164|Biological|ETBX-051|Ad5 [E1-, E2b-]-Brachyury
15962922|NCT03167164|Biological|ETBX-061|Ad5 [E1-, E2b-]-MUC1
15962923|NCT03167164|Biological|GI-6301|Heat-killed S. cerevisiae yeast expressing the human Brachyury (hBrachyury) oncoprotein
15962924|NCT03167164|Biological|haNK|NK-92 [CD16.158V, ER IL-2] (high-affinity activated Natural Killer cells)
15962925|NCT03167151|Drug|Pembrolizumab|Solution for Infusion (Intravesical and Intravenous) 100mg/ 4ml vial
15962926|NCT03167138|Biological|Autologous micro-fragmented adipose tissue|Micro-fragmented adipose tissue is obtained from abdominal region or thighs using the Lipogems® system and injected into the injury site under ultrasound guidance.
15962927|NCT03167138|Device|Lipogems system|The Lipogems® system is a non-enzymatic method to obtain micro-fragmented adipose tissue from the abdominal region or thighs for injection into the injury site.
15962928|NCT03167125|Other|Automated Prompts|This intervention is an automated data-driven program, using automated phone calls, text messages, and/or emails, for delivering FIT kit prompts to patients due for colorectal cancer screening. The specific components of the intervention are forthcoming and will be determined using a community-based participatory research approach known as boot camp translation which seeks input from patients and providers.
15962929|NCT03167125|Other|Automated Plus Live Prompts|This intervention is a higher-intensity program, using automated data-driven prompts plus linguistically and culturally tailored live prompts, for delivering FIT kit messages to patients due for colorectal cancer screening. The specific components of the intervention are forthcoming and will be determined using a community-based participatory research approach known as boot camp translation which seeks input from patients and providers.
15962930|NCT03167112|Drug|Oxaliplatin|Patients receive Oxaliplatin 85 mg/m2 over 2 hours.
15962931|NCT03167112|Drug|Irinotecan|Oxaliplatin is followed by Irinotecan (CPT-11) 180 mg/m2 over 90 min.
15962932|NCT03167112|Drug|Leucovorin|Oxaliplatin and Irinotecan is followed by Leucovorin (LV) 400 mg/m2 over 2 hours day1
15962933|NCT03167112|Drug|Fluorouracil|Oxaliplatin and Irinotecan and Leucovorin is followed by Fluorouracil (5-FU) 400 mg/m2 bolus day1 and 2,400 mg/m2 46h continuous infusion.
15962934|NCT03167099|Procedure|Full Weight Bearing|Participants will be randomized to one of two groups; full weight bearing, which is the intervention, or partial weight bearing, which is standard of care, after fixation of a distal femur fracture.
15962935|NCT03167086|Behavioral|"Empowered Relief (ER)"|"Empowered Relief (ER): A single-session skills-based approximately 2-hr group intervention to treat chronic pain.
~Format of intervention: Therapist-delivered PowerPoint presentation with experiential exercises. Experienced senior level psychologist and two (2) additional doctoral level psychologists will conduct the ER sessions.
~Content of intervention: ER Participants have the 'ER Relaxation Resource' app (guided relaxation audiofile) loaded on their apple or android electronic device."
15962936|NCT03167086|Behavioral|Cognitive Behavioral Therapy (CBT)|"Format of intervention: 8-week Manualized Pain-CBT Group Intervention will be delivered by PhD-level psychotherapists (3 in total). The group is run weekly for 8 consecutive classes. Each class is 2 hours with a midpoint break (16 hours total intervention time).
~Content of intervention: The protocol and materials were developed with funding from NIH/NCCAM R01 AT006226 (Dan Cherkin, PI) [1& 2], and include content from a pain-CBT program developed by Drs. Ehde, Dillworth, and Turner [3].
~Participants receive a workbook with homework and a copy of The Pain Survival Guide: How to reclaim your life © 2005 by Turk & Winter [4] for optional reading."
15962937|NCT03167086|Behavioral|Health Education (HE)|"Format of intervention: The HE class will be instructor taught and will involve a PowerPoint presentation and handouts. Two additional providers will be identified and trained to conduct the sessions. Selected instructors will have substantial health education experience.
~Content of intervention: HE content will include basic information such as nutrition and interacting with the healthcare system; these relatively 'inert' topics are unlikely to impart any specific effects typically found with a true psychobehavioral intervention."
15962938|NCT03167073|Other|BreastFeeding Friend (BFF)|A novel android app designed to improve breastfeeding rates among low-income women
15962939|NCT03167073|Other|dummy app|A novel android app that looks identical to the intervention app (BFF) but contains limited content.
15962940|NCT03167060|Device|Active RhinoChill|"Participants will be provided with a RhinoChill® device (Active) and an Intranasal Migraine catheter. Once they have the RhinoChill® device, they are asked to treat the next two of your migraines with the device. This requires a maximum of 10 minute intra-nasal treatment as soon as possible after the start of your migraine.
~The participation in the trial will last until 3 migraine headaches have been treated with the RhinoChill® device."
15962941|NCT03167060|Device|Control Rhinochill|"Participants will be provided with a RhinoChill® device (Sham) and an Intranasal Migraine catheter. Once they have the RhinoChill® device, they are asked to treat the next two of your migraines with the device. This requires a maximum of 10 minute intra-nasal treatment as soon as possible after the start of your migraine.
~The participation in the trial will last until 3 migraine headaches have been treated with the RhinoChill® device."
15962942|NCT03167047|Procedure|Caudal block|Caudal epidural
15962943|NCT03167047|Procedure|Nerve Block|Peripheral nerve block
15962944|NCT03167047|Drug|Standarising intraoperative pain relief|All patients will receive a standarised dose of paracetamol 15mg/kg and fentanyl 2mcg/kg.
15962945|NCT03167034|Drug|ACETAZOLAMIDE oral capsule|Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m
15962946|NCT03167034|Drug|Placebo oral capsule|Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m
15962947|NCT03167021|Other|Survey|This observational and transversal study will be conducted as a survey using the REDCap software and the response to this survey will be done online, in real time, with an automatic, secure and centralized data collection (CHU Clermont-Ferrand).
15962948|NCT03167008|Diagnostic Test|semen sample|-Semen samples will be collected from all patients Semen analysis will be examined after 2-5 days of sexual abstinence based on World Health Organization (WHO) (2010)
15962949|NCT03167008|Diagnostic Test|blood sample|blood samples will be taken &the following will be done Serum vitamin D level ,Serum calcium level ,Serum testosterone level ,luteinizing hormone (LH), and follicle-stimulating hormone (FSH), will be measured
15962950|NCT03166995|Other|Low impact aerobic exercise|The intervention will consist of working the muscles that are most affected by FMS through group exercises, which will be dynamic, fluid and aimed at improving functionality. Each session will consist of 60 minutes and will be divided into three parts: warm up (15 minutes); games, group dynamics and aerobics (30 minutes); and cool down with stretching for 15 minutes.
15963013|NCT03166462|Other|Evaluation by Sleep Medicine Specialists|Patients randomized to the intervention arm will be referred to the sleep medicine specialists for evaluation. All of their recommendations will be followed if indicated.
15962951|NCT03166995|Other|Postural exercises|The intervention will consist of performing postural exercises in prone, supine, sitting and standing position, as well as in quadrupedia. Each session will consist of 60 minutes and will be divided into three parts: warm up (15 minutes); postural exercises (30 minutes); and cool down with stretching for 15 minutes.
15962952|NCT03166982|Procedure|transvaginal approach|
15962953|NCT03166982|Procedure|laparoscopic approach|
15962954|NCT03166969|Procedure|Holter 21 days|
15962955|NCT03166956|Dietary Supplement|Glutamine and vitamin C enteral supplement|Subjects in the GA group received enteral supplement of 10 g L-glutamine and 90 mg vitamin C per serving provided by Nutritec-Enjoy Nutrition Inc. (Taipei, Taiwan). Subjects in the C group received isocaloric maltodextrin as placebo.
15962956|NCT03166943|Procedure|Systolic function by echocardiography|"Echocardiography for evaluation of systolic function:
~by biplane Simpson's method.
~by speckle tracking:"
15962957|NCT03166943|Procedure|Diastolic function by echocardiography|"Echocardiography for evaluation of diastolic function:
~Left atrial Volume
~Mitral Inflow Patterns
~Pulsed wave Doppler
~Mitral inflow patterns include normal, impaired left ventricular relaxation, pseudonormal, and restrictive left ventricular filling patterns.
~Tissue Doppler Annular Early and Late Diastolic Velocities
~Pulsed wave tissue doppler imaging
~Primary measurements include the systolic , early diastolic, and late diastolic velocities."
15962958|NCT03166930|Behavioral|Spasticity Take Control|Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and a stretching program for spasticity management.
15962959|NCT03166930|Behavioral|Stretching for People with MS: An Illustrated Manual|Participants will attend two 2-hour classes via video teleconference (online), one week apart, consisting of education and exercises for spasticity management from the manual.
15962960|NCT03166917|Procedure|3D printing implant|3D printing implants in bone defect
15962961|NCT03166917|Procedure|autogenous bone grafting|3D printing implants in bone defect
15962962|NCT03166904|Drug|Vistusertib(AZD2014)|Vistusertib(AZD2014) is a selective dual mTOR kinase inhibitor targeting both mTORC1 (rapamycin sensitive) and mTORC2 (rapamycin insensitive) complexes of mammalian Target Of Rapamycin (mTOR).
15962963|NCT03166891|Drug|Chiauranib|Take 50mg orally once daily
15962964|NCT03166878|Biological|UCART019|Day 0: 10% of total dose Day 1: 30% of total dose if patient is stable (no significant toxicity) from prior dose. D2: 60% of total dose if patient is stable (no significant toxicity) from prior dose
15962965|NCT03166865|Biological|Umbilical-cord mesenchymal stromal cells (UC-MSCs)|Allogeneic UC-MSCs 1 x 10~7 diluted on 5 mL of Platelet Rich Plasma
15962966|NCT03166865|Other|Hyaluronic acid|intra-articular injection of Hyaluronic Acid
15962967|NCT03166852|Other|Home-training|5 weeks of interval training at home. The training consisted of 3 minutes of warm-up. 10 intervals of 1 minute at 90% of maxHR interspersed with one minute of low intensity pedalling. Cool-down period of 2 minutes.
15962968|NCT03166839|Other|Experiencing PPH|No intervention given
15962969|NCT03166826|Other|Modified Apgar Scoring System|Modified APGAR scoring system
15962970|NCT03166813|Procedure|Remote Ischaemic Preconditioning|The intervention RIPC protocol will be performed each time by three cycles of inflation of a blood pressure cuff placed over the arm or leg of your child, where deemed to cause minimal discomfort, to 15 mmHg above the systolic blood pressure for 5 minutes followed by 5 minutes of cuff deflation to 0 mmHg.
15962971|NCT03166813|Other|Control|Placement of blood pressure cuff without inflation for 30 minutes.
15962972|NCT03166800|Drug|Mitoquinone|MitoQ will administered in either 20mg or 40mg capsules. The dose will administered for a 12-weeks treatment.
15962973|NCT03166787|Other|Charcoal hookah|The Myocardial Blood Flow (MBF) will be measured at rest and during the last minute of a 3-minute bout of handgrip at 30% Maximal voluntary contraction. This sequence will be performed before and after 12 young hookah smokers are randomized to smoke the same popular Starbuzz tobacco product heated with either charcoal for 30 min each.
15962974|NCT03166787|Other|E-coal hookah|"The Myocardial Blood Flow (MBF) will be measured at rest and during the last minute of a 3-minute bout of handgrip at 30% Maximal voluntary contraction. This sequence will be performed before and after 12 young hookah smokers are randomized to smoke the same popular Starbuzz tobacco product heated with electrically (Global First e-coal, ) for 30 min each."
15962975|NCT03166787|Other|Cigarette|The Myocardial Blood Flow (MBF) will be measured at rest and during the last minute of a 3-minute bout of handgrip at 30% Maximal voluntary contraction. This sequence will be performed before and after 12 young cigarette smokers smoke 2 cigarettes down to the stub over 30 min (to simulate real-world use).
15962976|NCT03166787|Drug|Carbon Monoxide inhalation|A subset (n=8) of the young hookah smokers will return on a later day and will be randomized to have coronary endothelial function assessed before and after inhaling 0.3 CO gas from a Douglas bag.
15962977|NCT03166787|Other|Room Air inhalation|A subset 8 of the young hookah smokers will return on a later day and will be randomized to have coronary endothelial function assessed before and after inhaling room air from a Douglas bag.
15962978|NCT03166787|Drug|vitamin C|in a subset of 6 subjects the study team will repeat the Myocardial Contrast Echocardiography and speckle tracking studies after pretreatment with either i.v. vitamin C .
15962979|NCT03166787|Drug|tadalafil|in a subset of 6 subjects the study team will repeat the Myocardial Contrast Echocardiography and speckle tracking studies after pretreatment with one dose of oral tadalafil.
15962980|NCT03166774|Other|Program of support of the sexual health|Patients included in the study have to answer to a questionnaire
15962981|NCT03166761|Drug|Dexamethasone|Dexamethasone injection into the sacroiliac joint
15962982|NCT03166761|Drug|Triamcinolone Acetonide|Triamcinolone injection into the sacroiliac joint
15963014|NCT03166449|Dietary Supplement|Neomune|Enteral feeding with Neomune was delivered within 24 to 48 h after admission or surgery according to Brain Trauma Foundation (BTF) Guidelines
15963015|NCT03166449|Dietary Supplement|Fresubin® HP energy|Enteral feeding with Neomune was delivered within 24 to 48 h after admission or surgery according to Brain Trauma Foundation (BTF) Guidelines
15963016|NCT03166436|Procedure|Radiofrequency ablation|radiofrequency ablation
15963017|NCT03166436|Procedure|Biliary stenting|biliary stenting
15963018|NCT03166423|Drug|MU001 patches (Investigational)|Patches containing snail slime, calendula extract and propolis extract
15962983|NCT03166748|Combination Product|Potassium Nitrate in Polycarboxylate cement|"The application of polycarboxylate cement containing 5% KNO3 for direct capping of traumatically exposed pulp in animal models did not result in any degenerative changes in dental pulp, thought creating optimal conditions for preservation of pulp vitality and root completion.
~Polycarboxylate cement has very thin film thickness and bonds firmly to the tooth structure, is capable of withstanding the overlying pressure during restoration procedures. The good adhesive properties of polycarboxylate cement containing 5% KNO3 guaranteed the closure of cavity, good and lasting protection of traumatically exposed dental pulp and the formation of alkaline environment possessing a strong antiacidic, anti-inflammatory and antibacterial effect of this pulp capping material, creating optimal conditions for expression of its natural reparative potential. The increased release of potassium nitrate from polycarboxylate cement by time, might be the cause of decreasing the inflammatory intensity"
15962984|NCT03166735|Drug|BI 1467335|once daily
15962985|NCT03166735|Drug|Placebo|once daily
15962986|NCT03166722|Other|Control group|SpO2 and HR monitoring and routine treatment during immediate transition
15962987|NCT03166722|Device|Study group|Cerebral NIRS measurement with INVOS 5100 during immediate transition in addition to SpO2 and HR monitoring
15962988|NCT03166709|Behavioral|Preventing Addiction Related Suicide (PARS)|PARS is a module designed for a single session of an Intensive Outpatient Program (IOP) including a specified combination of didactic presentations and group discussions. PARS topics include: Goals and Objectives; Suicide Overview; The Strong Link Between Addiction and Suicide; Suicide Myths and Facts; Common Triggers of Suicidal Thoughts and Behaviors; Warning Signs of Suicide; Suicide Risk Factors; Suicide Protective Factors; How You Can Prevent Addiction Related Suicide; Action Steps to Take if You or Someone You Know Becomes Suicidal
15962989|NCT03166709|Behavioral|Intensive Outpatient Program standard session|Intensive Outpatient Program (IOP) substance abuse group session focused on depression, grief, or managing emotions. Site-specific session topic is what that IOP usually provides and was chosen by agency leads prior to start of study.
15962990|NCT03166683|Other|Hemopatch|Liver resection surgery with collagen and polyethylene glycol haemostatic/sealant patch placement
15962991|NCT03166683|Other|Standard of care|Standard of care include other sealant / hemostatic devices as patches or liquid/gels
15962992|NCT03166670|Diagnostic Test|stool examination|collection of stool specimen and microscopic examination for parasites
15962993|NCT03166670|Diagnostic Test|real time polymerase chain reaction|evaluation of genotype of cryptosporidium in stool specimen
15962994|NCT03166657|Procedure|office hysteroscopy|A speculum is first inserted into the vagina. The hysteroscope is then inserted and gently moved through the cervix into uterus. Carbon dioxide gas or a fluid, such as saline will be put through the hysteroscope into uterus to expand it. The gas or fluid helps see the lining more clearly. The amount of fluid used is carefully checked throughout the procedure
15962995|NCT03166644|Device|Analgesia Nociception Index (ANI)-guided sufentanil administration|One recent observational study showed that ANI-guided remifentanil administration during vascular surgery resulted in low opioid consumption and low postoperative pain rates.
15962996|NCT03166631|Drug|BI 891065|Part A, B & C
15962997|NCT03166631|Drug|BI 754091|Part B & C
15962998|NCT03166618|Device|Juvéderm® VOLUMA XC|Juvéderm® VOLUMA XC hyaluronic acid injectable gel
15962999|NCT03166605|Drug|Simethicone|Giving simethicone before and after capsule ingestion.
15963000|NCT03166592|Device|Magnetic resonance imaging with contrast|injection of gadolinium contrast then acquisition of images with magnetic resonance imaging then spectroscopy
15963001|NCT03166579|Behavioral|Dialectical Behaviour Therapy|Dialectical Behaviour Therapy (DBT) is a psychological intervention which was originally developed for women with Borderline Personality Disorder. DBT is delivered by a team of multidisciplinary mental health professionals, and comprises of individual therapy sessions for each patient, group skills training sessions, phone coaching and consultation meetings for the clinicians on the DBT team. Group skills are delivered in blocks of three modules which teach mindfulness, distress tolerance, emotion regulation and interpersonal effectiveness. The three modules are delivered over a 24-week period and are then repeated.
15963002|NCT03166566|Device|Laminar drainage implant surgery.|A clear corneal traction suture was placed to achieve superior-temporal quadrant exposure, where a 90° conjunctival fornix-based flap was made, associated with two radial relaxing incisions. A half-thickness scleral tunnel (4.5 mm from the limbus and 4.0 mm wide) was made using a crescent blade and a superior-temporal iridectomy was performed through . Then, the tunnel end was shunted to the AC using a 1.5-mm-wide blade with a sharp tip. The LDI was inserted into the scleral tunnel so that its tip was positioned in the AC periphery and the implant was anchored to the sclera using 7-0 polypropylene thread with two separate sutures. Next, fistula function was assessed by the aqueous humor leakage test at the scleral tunnel entry site. Then, the conjunctiva was repositioned and running sutures were performed with 7-0 polyglactin for the relaxing incisions and mattress sutures were performed in the limbus using 10-0 nylon.
15963003|NCT03166553|Drug|Elemene|
15963004|NCT03166540|Other|cup of espresso coffee|Subjects will consume the assigned treatment for one month. Espresso coffee will be prepared by using coffee capsules. Serving size: approximately 45 mL. The last day of the intervention is the sampling day.
15963005|NCT03166540|Other|cocoa-based products containing coffee|Subjects will consume the assigned treatment (2 products per serving) for one month. Serving size: approximately 37 g. The last day of the intervention is the sampling day.
15963006|NCT03166527|Drug|Immune Globulin 10% Intravenous Solution|standard Immune lobulin 10% intravenous solution infusion at standard and high infusion rates.
15963007|NCT03166514|Dietary Supplement|Commercially Available Food Bar|
15963008|NCT03166514|Dietary Supplement|Placebo|
15963009|NCT03166501|Drug|Lanicemine|Three 60 min parenteral infusions over a 5 day period
15963010|NCT03166501|Drug|Placebo|Three 60 min parenteral infusions over a 5 day period
15963011|NCT03166488|Device|MRI|Subjects will receive an MRI sequence called Magnetic Resonance Elastography (MRE).
15963012|NCT03166475|Procedure|Surgical procedures|All the extractions were performed under local anaesthesia, minimally traumatic as possible. After the extraction, each patient was treated according to the group of their allocations.
15963057|NCT03166176|Drug|Vistusertib(AZD2014)|vistusertib(AZD2014) is selective inhibitor of mTOR kinases and inhibits signalling of both mTOR complexes, mTORC1 and mTORC2.
15963019|NCT03166423|Device|Conventional patches (Control)|Patches containing conventional formulations in medical devices for ulcers (hydrocolloids, activated charcoal silver, alginate, carboxymethylcellulose or hydrogel).
15963020|NCT03166410|Procedure|Cell injection|
15963021|NCT03166397|Drug|Fludarabine|Cyclophosphamide 30mg/kg/day with Fludarabine (25 mg/m2/d) followed by 3 consecutive days of Fludarabine 25mg/m2/d.
15963022|NCT03166397|Drug|Cyclophosphamide|Cyclophosphamide 30mg/kg/day with Fludarabine (25 mg/m2/d) followed by 3 consecutive days of Fludarabine 25mg/m2/d.
15963023|NCT03166397|Biological|TIL|TIL administration
15963024|NCT03166397|Drug|IL-2|Bolus high-dose (720,000 IU/kg) IL-2 will be administered to each patient every 8 hours, to tolerance. A maximum of 10 doses will be administered per patient.
15963025|NCT03166384|Device|electrosurgical bipolar sealing devices|Electrosurgical bipolar sealing devices use the body's own collagen and elastin to create a permanent fusion zone through a combination of pressure and energy. Previous studies suggested that surgery using these devices lead to significant decrease of seroma formation, however their advantages are not well established in case of mastectomy for breast cancer.
15963026|NCT03166384|Procedure|conventional suture and tie|the surgeon uses electrosurgical bipolar sealing device during tissue dissection and vessel ligation as much as possible.
15963027|NCT03166371|Dietary Supplement|Liposomal Glutathione (GSH)|Two teaspoons (containing 840 mg GSH, 420 mg/tsp) liposomal GSH (ReadiSorb®) will be taken orally twice daily for a total daily dose of 1680 mg GSH/day. Liposomal GSH will be refrigerated until use and mixed in ≈ 250 mL water or juice for oral intake. The study product will be consumed daily for 90 consecutive days after hospital discharge.
15963028|NCT03166371|Other|Placebo|Two teaspoons of placebo product will be taken orally twice daily. The placebo will be refrigerated until use and mixed in ≈ 250 mL water or juice for oral intake. The placebo will be consumed daily for 90 consecutive days after hospital discharge.
15963029|NCT03166358|Behavioral|Hatha yoga|8 Hatha yoga classes lasting approximately one hour each and delivered in small group format (i.e., classes no larger than 8 participants). Classes are tailored to address pediatric tension-type headache.
15963030|NCT03166345|Other|Treatment of Thin Endometrium|This is a trial to improve endometrial thickness by autologous injection of PRP into the Uterine Cavity compared with CSF or no treatment.
15963031|NCT03166332|Behavioral|Mediterranean diet|Mediterranean diet supplemented with extra-virgin olive oil and nuts
15963032|NCT03166332|Behavioral|Mindfulness|Mindfulness-Based Stress Reduction program (MBSR)
15963033|NCT03166319|Device|MRI, including intracranial vessel wall imaging|MRI/MRA/intracranial high-resolution vessel wall imaging (HR-VWI)
15963034|NCT03166306|Diagnostic Test|PET-CT Imaging with [89Zr]-bevacizumab|Subjects will receive 1 millicurie of 89Zr and less than 5 mg of bevacizumab, followed by PET-CT imaging.
15963035|NCT03166293|Behavioral|Intensive leg training with a physical therapist|Intensive, self initiated activities of the lower extremities including walking over ground or on a treadmill (with or without support), kicking, jumping, standing balance, climbing stairs and slopes and other leg activities. Small weights will be added to the ankle and foot to increase the intensity of the exercise. A physical therapist will supervise sessions.
15963036|NCT03166280|Drug|Sofosbuvir 400 mg|treatment for hepatitis c by sofosbuvir (Sovaldi) 400 mg/day
15963037|NCT03166280|Drug|Daclatasvir 60 mg/day|treatment for hepatitis c by Daclatasvir 60 mg/day
15963038|NCT03166267|Device|External fixator|Tibia fracture (AO 41-43) treated with external fracture fixation (large external fixator)
15963039|NCT03166254|Drug|Pembrolizumab|-Pembrolizumab will be given intravenously over the course of 30 minutes
15963040|NCT03166254|Biological|NEO-PV-01 vaccine|-Generation of the vaccine is expected to take approximately 12 weeks
15963041|NCT03166254|Procedure|Biopsy|-Surgical or core needle biopsy of an accessible site for DNA and RNA sequencing, immunological analysis, and generation of NEO-PV-01 vaccine
15963042|NCT03166254|Drug|Poly ICLC|-NEO-PV-01 is combined with the adjuvant poly-ICLC prior to administration.
15963043|NCT03166254|Procedure|Leukapheresis|-Peripheral blood mononuclear cells (PBMCs) for comprehensive immune system monitoring will be obtained from leukapheresis samples collected up to 7 days prior to initiation of NEO PV-01 vaccination and at 7 days (Week 20) following the first NEO-PV-01 booster vaccination.
15963044|NCT03166254|Procedure|Peripheral blood samples|-Blood samples (80 mL) for immune monitoring will be obtained prior to study treatment and at Weeks 6, 14, 16, 24, 36, 48, 63, 75, 87, and 99.
15963045|NCT03166241|Diagnostic Test|serum interleukin 21|it is cytokine used as a marker to detect it's level in patients with adverse drug reactions
15963046|NCT03166241|Diagnostic Test|Complete Blood Picture|It is a blood sample will taken from patients to detect any abnormalities in blood component at the start of the study
15963047|NCT03166241|Diagnostic Test|Liver function test|It is a blood sample will taken from patients to detect any associated liver disease at the start of the study
15963048|NCT03166241|Diagnostic Test|Random Blood Sugar|measure blood sugar in patients included in the study at the start of the study
15963049|NCT03166241|Diagnostic Test|Erythrocyte Sedimentation Rate|blood sample will be taken from patients to detect any abnormalities in erythrocyte sedimentation rate at the start of the study
15963050|NCT03166241|Diagnostic Test|Kidney function tests|blood sample will be taken from patients to detect any kidney disease before the start of the study
15963051|NCT03166228|Drug|Normal Saline 0.9% Infusion Solution Bag|0.9% saline as distension medium as long as diathermy is not in use
15963052|NCT03166228|Drug|1.5% Glycine only|1.5% Glycine alone during hysteroscopy as long as diathermy is in use
15963053|NCT03166215|Drug|TAK-935|TAK-935 tablets.
15963054|NCT03166215|Drug|Placebo|TAK-935 placebo-matching tablets.
15963055|NCT03166189|Biological|bone marrow-derived MSC and HRT|"Transplantation procedure to endometrial cavity is performed with ultrasound guidance on menstrual cycle day 5-6 through uterine cervix using cater for embryo transfer with 1 ml of suspension containing 5 millions of autologous bone marrow-derived mesenchymal stem cells
~Three cycles of HRT following MSC transplantation;
~Pipelle-biopsy of endometrium on day 20 of hormonal replacement therapy of the last (third) cycle;
~Frozen/thawed embryo transfer 3-6 months after transplantation."
15963056|NCT03166189|Other|hormonal replacement therapy|"standard treatment of hypoplastic endometrium or Asherman's syndrome:
~Three cycles of HRT preceding frozen/thawed embryo transfer;
~Frozen/thawed embryo transfer."
15963058|NCT03166163|Drug|Azadirachta indica|Its a herbal mouthwash that will be given to group of Egyptian Children twice daily for 3 weeks
15963059|NCT03166163|Drug|Chlorhexidine mouthwash|its an antimocrobial, antiplaque mouthwash that will be given to a group of Egyptian children twice daily (10 ml each) for 3 weeks
15963060|NCT03166150|Other|Multi-modal rehabilitation program|Patients will receive 12 weeks of exercises.
15963061|NCT03166150|Other|Pelvic Floor Physical therapy|Pelvic Floor Physical therapy
15963062|NCT03166137|Device|Carbon dioxide laser|Radiation by carbon dioxide laser
15963063|NCT03166137|Device|Cryotherapy|Device using cooling effect
15963064|NCT03166124|Drug|LY900014|Administered SC
15963065|NCT03166124|Drug|Insulin Lispro|Administered SC
15963066|NCT03166111|Drug|lidocaine gel|syringe filled with 5 ml gel to be self-administered vaginal 10 minutes prior to insertion
15963067|NCT03166111|Drug|placebo gel|syringe filled with 5 ml gel to be self-administered vaginal 10 minutes prior to insertion
15963068|NCT03166098|Diagnostic Test|Cognitive Function Assessments|The NIMH-Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) is a consensus battery that is considered state-of-the art in the evaluation of cognitive skills for schizophrenia research.(Burton et al., 2013, Harvey, 2014) The complete cognitive battery takes about one hour to administer, and is comprised of 10 subtests measuring seven essential domains of function, with very good reliability and validity.(Nuechterlein 2008, August et al., 2012) The MATRICS subtests have been incorporated into the cognitive battery described below, with supplementary subtests included where indicated within each domain.
15963069|NCT03166085|Drug|PU-H71|PU-H71 will be given as an intravenous infusion on Day 1 of a 21 day cycle
15963070|NCT03166085|Drug|Nab-paclitaxel|nab-paclitaxel will be administered at a dose of 260mg/m2 intravenously on Day 1
15963071|NCT03166072|Other|Low-vision rehabilitation program|Low Vision Rehabilitation Program includes functional vision assessments (low-vision refraction), prescription of a variety of visual aids including microscopes, magnifiers, telescopes, absorptive filters and electronic spectacle eyewear, large print books, and automatic self-transcending meditation plus essential skills for daily living and mobility training offered by CNIB including demonstration of visual aids as well as training on proper use of visual aids.
15963072|NCT03166072|Other|No Intervention|Participants will continue to receive treatment as usual
15963073|NCT03166059|Device|CaveoVasc® Thrombolysis Protection System|CaveoVasc® Thrombolysis Protection System for Femoral Artery Access and Protection in Patients Treated with Thrombolysis for Limb Ischemia
15963074|NCT03166046|Device|Pulsed Shortwave Therapy|Stimulation of the supratrochlear and supraorbital branches of the ophthalmic nerve.
15963075|NCT03166046|Device|Placebo Pulsed Shortwave therapy|Placebo Stimulation of the supratrochlear and supraorbital branches of the ophthalmic nerve.
15963076|NCT03166033|Other|the disease|Observation the patients and non-patients
15963077|NCT03166020|Other|Rehabilitation|An occupational therapist will be required only for patient installation in front of the table.
15963078|NCT03166007|Behavioral|Abdominal massage|The participant should be supine and in a relaxed atmosphere, though this may depend on level of disability. The massage comprises 4 basic strokes (10minutes); Stroking from the small of the back over the iliac crest and down both sides of the pelvis towards the groin; Effleurage follows the direction of the ascending colon across the transverse colon and down the descending colon. This is repeated several times with increasing pressure; Palmar kneading tracks down the descending colon up the ascending colon and down the descending colon once again. Effleurage is repeated and continued with a relaxing transverse stroke over the abdomen; Vibration over the abdominal wall to relieve flatus concludes the massage session. The participants in this group will receive one telephone call per week for 6 weeks and again at 24 weeks to further discuss their bowel management.
15963079|NCT03166007|Behavioral|Optimised bowel care|During a 1 hour outpatient appointment, the participants' existing bowel care routine will be reviewed and optimised. For example, explaining the necessity of adequate fluid intake. No change in medication will be advocated. The participants in this group will also receive one telephone call per week during the following 6 week period to further discuss their bowel management and again at 24 week time point.
15963085|NCT03165981|Biological|PCV13|ACIP Recommended vaccine
15963086|NCT03165981|Biological|DTaP|ACIP Recommended vaccine
15963087|NCT03165981|Biological|IIV|ACIP Recommended vaccine
15963088|NCT03165968|Device|Neuro Kinetics, Inc, i-PAS|This is a test of i-PAS device reliability only.
15963089|NCT03165955|Drug|Oraxol|HM30181 methanesulfonate monohydrate - supplied as 15-mg HM30181AK-US tablets, Paclitaxel - supplied as 30-mg capsules
15963090|NCT03165942|Other|Alcoholic Beverage|In addition to the oral delivery, an IV line will be placed for the purpose of drawing blood during the MRI session.
15963091|NCT03165942|Other|Non-Alcoholic Beverage|In addition to the oral delivery, an IV line will be placed for the purpose of drawing blood during the MRI session.
15963092|NCT03165942|Drug|Ethanol|
15963093|NCT03165929|Drug|Flurbiprofen|oral flurbiprofen spray
15963094|NCT03165929|Drug|placebo|oral placebo spray
15963095|NCT03165916|Device|Bard 5 Fr diameter feeding tube|A pediatric feeding tube is used as a stent over which biliary anastomosis is performed. This is not a permanent stent and generally migrates out on its own.
15963128|NCT03165617|Biological|QIVc|Cell-derived Quadrivalent Influenza Vaccine for intramuscular use containing each of the 2 influenza type A strains and each of the 2 influenza type B strains
15963129|NCT03165617|Biological|Non-influenza Comparator Vaccine|Non-influenza comparator vaccine for intramuscular use
15963130|NCT03165604|Other|standard information|The participates will be given a standard information regarding the water drink before physical activity
15963131|NCT03165604|Other|positive information|"The participates will be given positive information (the drink will be presented as an energy drink) regarding the drink before physical activity"
15963096|NCT03165903|Behavioral|Cue and Implementation Intention-Based Intervention|Families from a school assigned to Cue and Implementation Intention-Based Intervention received an intervention targeting increased levels of healthy snacking and reduced levels of sugar sweetened beverage consumption. The intervention consisted of a 90-minute meeting with a trained Health Coach, two 20-minute phone calls, 4 tailored newsletters, and a series of emails and text messages. Cues for snacking and sweetened beverage consumption were removed or relocated and implementation-intentions were created to trigger alternative behaviors to snacking and sweetened beverage consumption in the presence of cues. Both interventions were delivered over 3-10 weeks depending on the self-directed pace of the participants. All participants completed a follow-up assessment 3 months after consent.
15963097|NCT03165903|Behavioral|Control arm|Families that were from a school assigned to Control received an intervention on sun safety that consisted of a 10-minute meeting with a trained Health Coach, 2 generic newsletters, an email, and a text message. Both interventions were delivered over 3-10 weeks depending on the self-directed pace of the participants. All participants completed a follow-up assessment 3 months after consent.
15963098|NCT03165890|Drug|ACETAZOLAMIDE oral capsule|Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m
15963099|NCT03165890|Drug|Placebo oral capsule|Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m
15963100|NCT03165877|Other|Low-glycemic index|Subjects ate low-glycemic index lunches and dinners (<55%),consisting of salad, main course and dessert, respectively.
15963101|NCT03165877|Other|Control|Subjects ate standard lunches and dinners (>60%),consisting of salad, main course and dessert, respectively.
15963102|NCT03165864|Drug|IONIS TMPRSS6-Lrx|Ascending single and multiple doses of IONIS TMPRSS6-Lrx administered subcutaneously
15963103|NCT03165864|Other|Placebo|Saline .9%
15963104|NCT03165851|Other|Risk-stratified therapy|Dose-dense intensive chemotherapy and high dose of Ara-C in the consolidation therapy.
15963105|NCT03165838|Behavioral|Postpartum Visit 3-4 Weeks|This visit will be the same as the standard of care postpartum visit, but it will be scheduled earlier.
15963106|NCT03165838|Behavioral|Postpartum Visit 6-8 Weeks|This standard of care postpartum visit will be scheduled for the standard time interval.
15963107|NCT03165825|Drug|Transforaminal Epidural Steroid Injection with Dexamethasone|Transforaminal Epidural Steroid Injection with Dexamethasone
15963108|NCT03165825|Drug|Interlaminar Epidural Steroid Injection with Betamethasone|Interlaminar Epidural Steroid Injection with Betamethasone
15963109|NCT03165812|Procedure|SADJB-SG group|Patients will undergo bariatric surgery. A clear liquid high protein diet will be started in the first two postoperative days. If no complications were detected by physical examination, patients will be stimulated to walk and will be dismissed from the hospital on postoperative day 3. Patients will be subjected to a strict adherence to diet and close monitoring of their blood glucose and HbA1c levels during the study period. Standard follow-up includes a visit to the outpatient clinic at 1, 2, 3, 4 weeks after surgery, then 3, 6, 9, 12, 18, 24 months and after that, a life-long annual visit. Glycaemic control at home will be maintained as in the preoperative period and patients will need to inform the results of their blood glucose levels to the doctor during each follow-up visits.
15963110|NCT03165812|Procedure|IMT group|Patients will be subjected to strict adherence to their diet, optimisation of their diabetic medications and close monitoring of their blood glucose and HbA1c levels at 0, 6, 12, 24 months. The endocrinologist will be monitoring the patients in this group. Detailed individualized lifestyle and dietary counseling will be given by a dietitian emphasizing on nutrition knowledge, the timing of meal with medication, portion control, and increasing daily physical activity level.
15963111|NCT03165799|Behavioral|Mindfulness Education|Mindfulness Education
15963112|NCT03165786|Behavioral|FREE|Cognitive behavioral therapy with real-time continuous glucose monitoring.
15963113|NCT03165773|Other|Oatmeal|Intervention involves consumption of one cereal in the beginning of each visit of the crossover sequence
15963114|NCT03165773|Other|Corn grits|Intervention involves consumption of one cereal in the beginning of each visit of the crossover sequence
15963115|NCT03165760|Procedure|protective ventilation|the aim of the intervention is to ovoid Ventilator induced lung injury and inflammatory stress
15963116|NCT03165747|Drug|VSL#3|8 strains of live bacteria: Bifidobacterium breve, B. longum, B. infantis, L. acidophilus, L. plantarum, L. paracasei, L. bulgaricus and Streptococcus thermophilus. 900 billion CFU taken orally daily in a single administration.
15963117|NCT03165747|Other|Placebo|Two placebo sachets taken orally daily in a single administration.
15963118|NCT03165734|Drug|Pacritinib|Oral administration. Supplied in capsules containing 100 mg (as the free base) in red cap/gray body size 0 opaque hard gelatin capsules. The inactive ingredients are microcrystalline cellulose, magnesium stearate, and polyethylene glycol 8000. Each capsule contains 146 mg of pacritinib citrate, which is equivalent to 100 mg pacritinib free base
15963119|NCT03165734|Drug|Physician's Choice medications|Physician's Choice medications will be selected and administered according to the investigator's judgement. Investigators can select individual P/C agents but cannot combine agents or give them sequentially.
15963120|NCT03165721|Drug|SGI-110 (guadecitabine)|SGI-110 will be administered subcutaneously at 45mg/m^2/day x 5 days on a 28-day cycle. Cycles may be repeated until there is evidence of tumor progression clinically or by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or there is intolerable toxicity that is not alleviated by dose reduction.
15963121|NCT03165695|Drug|Ramelteon|Ramelteon 8 mg tablet orally at 21:00 for 7 days or until discharge whichever comes first
15963122|NCT03165695|Drug|Placebo|Placebo, 1 tablet orally at 21:00 or until discharge whichever comes first
15963123|NCT03165669|Device|"Viscospring PostuRite - medium model"|Cervical pillow use, 30-minutes instruction session supported by a brochure
15963124|NCT03165669|Other|Education|30-minutes educational session delivered by a physical therapist and supported by an informative brochure.
15963125|NCT03165643|Diagnostic Test|OGTT|75 g glucose tolerance test was provided to all pregnant women during 24-28 weeks.
15963126|NCT03165630|Behavioral|Transportation incentives|Free transportation only for the first 3 months post-discharge.
15963127|NCT03165630|Behavioral|Transportation and rehabilitation services incentives|Free transportation and rehabilitation services 3 months post-discharge.
15963132|NCT03165591|Biological|V3-P|one tablet of V3-P given once daily for 2 months
15963133|NCT03165578|Other|Neurofeedback training|In a neurofeedback setting, brain activity is measured non-invasively, the brain imaging data is analyzed in real-time, and then feedback regarding the current level of brain activity is provided to the subject.
15963134|NCT03165578|Other|Sham Feedback|Sham controlled neurofeedback training. Subjects in the sham control group will undergo the same procedure as subjects in the experimental group, but instead of being shown feedback derived from their own brain activity, they will be shown replayed feedback values from a randomly chosen subject of the experimental group.
15963135|NCT03165565|Behavioral|Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT)|Participants will receive Motivational Interviewing (MI) and Acceptance and Commitment Therapy (ACT).
15963136|NCT03165565|Behavioral|Conventional Care|Conventional care from the hospital for NICU mothers who test positive for drug use, which includes visits and resources from hospital social workers.
15963137|NCT03165552|Other|Acute kidney injury education|A face to face, a constructivist learning approach to encourage users to explore and learn about the topic of AKI in a way that maximises educational value. The programme is supported by a web based resource that presents a series of realistic case studies highlighting common causes of AKI in primary care designed to be easy to access and navigate, whilst being visual and interactive to enhance user engagement. The educayion is delivered to healthcare staff not to patients.
15963138|NCT03165539|Device|Cerebral oxygen saturation monitoring|Intraoperatively, patients will have baseline cerebral oxygen saturation monitoring while breathing room air. Cerebral oxygen saturation monitoring will continue throughout the entire operation including the time on one-lung ventilation.
15963139|NCT03165526|Device|AMPLATZER™ Post-infarct Muscular VSD Occluder|The AMPLATZER™ PIVSD Occluder is intended for percutaneous transcatheter closure of post-myocardial infarct muscular VSDs in patients who are not satisfactory surgical candidates.
15963140|NCT03165513|Behavioral|mhGAP-IG|psychosocial interventions
15963141|NCT03165500|Drug|Diazepam|"Patients' vital signs (blood pressure, heart rate and oxygen saturation) were measured and recorded after 30 minutes of oral sedation with diazepam 5mg, during the extraction procedure and 15 minutes after the extraction.
~After the surgical procedure of extraction, the patients remained in recovery in the same room, being the criteria of discharge realized, from the normality of the vital signs and the response to the verbal commands, with the patient responsive and lucid."
15963142|NCT03165500|Drug|Midazolam|"Patients' vital signs (blood pressure, heart rate, and oxygen saturation) were measured and recorded after 30 minutes of oral sedation with midazolam 7.5mg during the extraction procedure and 15 minutes after the extraction.
~After the surgical procedure of extraction, the patients remained in recovery in the same room, being the criteria of discharge realized, from the normality of the vital signs and the response to the verbal commands, with the patient responsive and lucid."
15963143|NCT03165500|Drug|Nitrous Oxide + Oxygen Gas|"Patients' vital signs (blood pressure, heart rate, and oxygen saturation) were measured and recorded after 30 minutes of sedation Inhalation with the mixture of 40% of nitrou oxide and 60% of oxygen, during the exodontia procedure and 15 minutes later.
~After the surgical procedure of extraction, the patients remained in recovery in the same room, being the discharge criteria performed, from the normality of the vital signs and the response to the verbal commands, with the patient responsive and lucid, and after the accomplishment of the test developed by Trieger et al.,(1971)."
15963144|NCT03165500|Procedure|Third molar extraction|Anxious patients in need of third molar extraction
15963145|NCT03165487|Other|Breast tissue collection|During Breast Conservation Surgery, one sample will be collected before and after IORT.
15963146|NCT03165487|Other|Blood sample collection|Blood will be collected before and after IORT, and at the two week follow-up.
15963147|NCT03165474|Other|Web-based comic and newsletters|Web-based comic and health messages (child component) and health newsletters (parent component)
15963148|NCT03165474|Other|Didactic health information|Didactic health information and resources by email and/or text
15963149|NCT03165448|Diagnostic Test|Pre-operative USOS scale testing|Patient has to self-report USOS questionnaire just before the procedure as main scale.
15963150|NCT03165448|Diagnostic Test|Pre-operative SDPQ, MDAS and VAS testing|Patient has to sel-report SDPQ, MDAS and VAS questions as control scales.
15963151|NCT03165448|Diagnostic Test|Post-operative doctor's reported USOS|Operating doctor has to fill the USOS doctor's part o questionnaire just after the procedure.
15963152|NCT03165448|Diagnostic Test|Re-testing 4-6 weeks later|All the participants has to refill USOS questionnaire 4-6 weeks later.
15963153|NCT03165435|Biological|CV-MG01|3 consecutive subcutaneous injections of CV-MG01. The three injections are planned for each patient on Days 1, 29 (+/- 3 days) and 85 (+/- 7 days), respectively.
15963154|NCT03165435|Biological|Placebo|3 consecutive subcutaneous injections of placebo. The three injections are planned for each patient on Days 1, 29 (+/- 3 days) and 85 (+/- 7 days), respectively.
15963155|NCT03165422|Other|Non-Interventional|Non-Interventional
15963156|NCT03165409|Biological|Nivolumab|Melanoma intervention
15963157|NCT03165409|Biological|Ipilimumab|Melanoma intervention
15963158|NCT03165396|Drug|Propofol|Propofol is the most common clinical anesthetics.
15963159|NCT03165396|Drug|Sevoflurane|Sevoflurane is the most common clinical anesthetics.
15963160|NCT03165383|Drug|Bupivacaine (Transversus Abdominis Plane Block)|Intervention - At the end of surgery Ultrasound guided Transversus Abdominis Plane block was given with 20 ml 0.25 % bupivacaine bolus and repeated every 8 hourly up to 24 hours.
15963161|NCT03165383|Drug|Intravenous Patient Controlled Analgesia (PCA) Morphine|PCA Intravenous Morphine 1 milligram bolus on demand was given as rescue analgesia up to 24 hours.
15963162|NCT03165357|Dietary Supplement|Sodium bicarbonate supplementation|
15963163|NCT03165357|Dietary Supplement|Placebo treatment|
15963164|NCT03165344|Other|Hydrocortisone sodium succinate mixed with Aluminium Phosphate gel (route of administration)|the test group begin to take hydrocortisone sodium succinate mixed with Aluminium Phosphate gel after 24 hours and gradually reduse the dose.
15963165|NCT03165344|Other|Triamcinolone Acetonide (route of administration)|The control group will get local injection of triamcinolone acetonide in wound during the operation.
15963166|NCT03165344|Other|Prednisone (route of administration)|The control group begin to take oral prednisone after 24 hours and gradually reduse the dose.
15963167|NCT03165331|Other|Ung Face IT|Ung Face IT is an online intervention tool (programme) that provides easy access to specialist advice and support via a home computer/tablet, using illustrations, information, videos, and interactive activities, and a discussion forum for participants only (supervised by the research team). Through these tools, it provides advice and teaches coping skills based on cognitive behavioural therapy and social interaction skills training.
15963168|NCT03165318|Device|Pulsed Electromagnetic Field Therapy|"Participants of this arm will be exposed to 10 minutes of Pulsed Electromagnetic Field (PEMF) once a week for a total of 16 weeks.
~The PEMF device produces pulsed magnetic fields at flux densities up to 1 mT peak."
15963169|NCT03165318|Device|Sham Therapy|"Participants of this arm will be exposed to 10 minutes of sham therapy once a week for a total of 16 weeks.
~The Sham device is identical to the PEMF device in physical appearance."
15963170|NCT03165305|Other|Sustained Inflation|Administering a pressure of 30 cm H20 by a T-piece resuscitator for 5 seconds immediately after birth.
15963171|NCT03165292|Radiation|131I-mIBG|Day 1 131I-mIBG course 1: about 444MBq/kg with in vivo whole-body dosimetry Day 15 131I-mIBG course 2: the target is to deliver a combined whole-body radiation dose of 4 Gy
15963172|NCT03165292|Drug|Topotecan|Day 1-5 Topotecan 0.7 mg/m^2 daily Day 15-19 Topotecan 0.7 mg/m^2 daily
15963173|NCT03165292|Drug|Thiotepa|Day 1-3 Thiotepa 300 mg/m^2/day
15963174|NCT03165292|Procedure|Autologous stem cell transplant|ASCT as soon as radiation level allows it in ARM A
15963175|NCT03165279|Procedure|Zenith Alpha Abdominal stentgraft|
15963176|NCT03165266|Diagnostic Test|Two dimensional Echocardiography|"I- Routine transthoracic assessment for Left Atrium and Left Ventricle dimensions :
~II- transthoracic assessment of the Right ventricular systolic function by:
~. Right Ventricle fractional area change.
~. Tricuspid annular plane systolic excursion .
~. Tissue Doppler derived tricuspid annular systolic velocity.
~. Right ventricle myocardial performance index . III- Assessment of Right ventricular diastolic function: is carried out by pulsed Doppler of the tricuspid inflow, or tissue Doppler of the lateral tricuspid annulus.
~IV Assessment of Right Ventricle chamber quantification:
~Right ventricular basal, mid ,and longitudinal dimensions.
~Right ventricular Outflow Tract, and wall thickness V- Assessment of right atrial major ,and minor dimensions ,and right atrial End- systolic area IV- Assessment of longitudinal Right ventricular strain and strain rate by speckle tracking"
15963177|NCT03165253|Drug|Bifidobacterium Animalis Oral Product|The synbiotic group will receive this product.
15963178|NCT03165253|Drug|Amoxicillin Oral Tablet|50mg/kg/day B.I.D.
15963179|NCT03165253|Drug|Clarithromycin Oral Tablet|15 mg/kg/day B.I.D.
15963180|NCT03165253|Drug|Omeprazole|1 mg/kg/day
15963181|NCT03165240|Drug|BI 690517|Film-coated tablet
15963182|NCT03165240|Drug|Eplerenone|Film-coated tablet
15963183|NCT03165240|Drug|Placebo|Film-coated tablet
15963184|NCT03165227|Drug|BI 685509|Taken orally
15963185|NCT03165227|Drug|Placebo|Taken orally
15963186|NCT03165214|Device|coil|microcoils
15963187|NCT03165214|Device|hystoacryl glue|hystoacryl mixed with lipidol
15963188|NCT03165201|Device|LiverMultiScan|We will study participants who are due to be evaluated for possible liver transplant rejection. There will be no change to usual care as part of the study, but patients will get an additional MRI scan, so that the results can be compared to the biopsy results. Each centre has a consultant radiologist specialising in liver imaging with experience in post-transplant review; the radiologist will review the MRI scans and inform the patient's doctor if any structural liver abnormalities are found (e.g. abnormal vessels, haemangiomas, tumours or cysts) as this may have implications for the patient's planned biopsy.
15963189|NCT03165175|Behavioral|prescription drug-abuse education smartphone application|As a patient-centered prevention effort, this brief intervention in a mobile phone app format focuses on helping military members reduce their risk for prescription drug misuse. It contains modules to: (1) assess risk for misuse and related behavioral health concerns; (2) provide individualized feedback on risk level; (3) store information on current medications and look up drug interaction and related information; (4) enhance communication and decision-making skills within healthcare and other interpersonal contexts by providing interactive scenarios; (5) teach about the risks of prescription drug misuse; and (6) provide available resources for help with prescription drug misuse.
15963190|NCT03165162|Behavioral|Food Order|randomly assigned orders of 7 bowls of granola, each with a different food label.
15963191|NCT03165149|Drug|group (A)|patients will receive 1mg / kg of Ketamine diluted by 20 ml saline (0.9 % ) and irrigated onto surgical field after hemostats and before skin closure.
15963192|NCT03165149|Drug|group (B)|patients will receive 2 mg /kg of Ketamine diluted by 20 ml saline (0.9 %) and irrigated onto surgical field after hemostasis and before skin closure.
15963193|NCT03165149|Drug|group (c)|patients will receive 3 mg /kg of Ketamine diluted by 20 ml saline (0.9 %) and irrigated onto surgical field after hemostasis and before skin closure.
15963194|NCT03165136|Drug|Hydroxychloroquine|Hydroxychloroquine : 200 mg twice a day
15963195|NCT03165136|Drug|Placebo|placebo of hydroxychloroquine
15963196|NCT03165123|Drug|Oral Azithromycin tablet|Oral azithromycin tablet will be given one hour before induction of anaesthesia.
15963197|NCT03165123|Drug|Intravenous dexamethasone|5 mg of intravenous dexamethasone is given within one to two minutes after the umbilical cord is clamped.
15963198|NCT03165110|Device|Onyx BG Meter / App System|Subjects with diabetes used the Onyx BG Meter / App System at home and assessed the features of the App.
15963199|NCT03165097|Drug|ACT-709478|Hard gelatine capsules for oral administration
15963200|NCT03165097|Drug|Placebo|Placebo capsules matching ACT-709478 capsules
15963201|NCT03165097|Drug|Midazolam|Midazolam oral solution (2 mg/mL) applied with a syringe
15963202|NCT03165097|Drug|ACT-709478 combined with midazolam|Hard gelatine capsules for oral administration (ACT-709478) to be taken first followed by Midazolam oral solution (2 mg/mL) applied with a syringe
15963203|NCT03165084|Behavioral|Intervention arm: Person-centred interactive self-management support|"Person-centred tailored digital self-management support hypothesised to decrease HbA1c, improve other metabolic measurements, improve lifestyle habits, and increase diabetes empowerment, increase diabetes-dependent quality of life, improve illness perception, and improve eHealth literacy.
~Access to the diabetes mobile application and the homepage during 16 weeks. Each individual will set personal goals for use of the digital resources."
15963204|NCT03165084|Other|Control arm|Participants will receive usual care and take part in a minimal intervention in the form of a brochure on the importance of self-management in diabetes.
15963205|NCT03165084|Other|External comparison group|External comparison groups in order to analyse possible Hawthorne effects.
15963206|NCT03165071|Drug|ACT-132577|Capsule
15963207|NCT03165058|Diagnostic Test|mucosal impedance (MI) testing|During routine colonoscopy, consented study participants will have a MI catheter sensor positioned along the mucosal wall to measure resistance across the mucosa. The physician will take measurements in each segment of the colon, including segments that appear inflamed and normal adjacent areas (up to 10 locations). To obtain a stable reading, the sensor must remain in contact with the mucosa for five seconds. The study procedure will add approximately 1-2 minutes of anesthesia time for each participant. Basic demographic information, prior IBD treatments, and prior colonoscopic data will be collected from the medical record following the procedure for those patients who consent to research.
15963208|NCT03165045|Drug|Spiolto® Respimat®|6 weeks
15963209|NCT03165006|Procedure|Mode of detection: Cancer detected at screening|Cancers detected as a result of screening mammograms.
15963210|NCT03165006|Procedure|Mode of detection: Interval cancer|Cancers diagnosed after a negative screening mammogram and before the next screening invitation (2 years in Spain)
15963211|NCT03164993|Drug|Atezolizumab|Atezolizumab is a monoclonal antibody designed to target and bind to a protein called PD-L1 (programmed death ligand-1), which is expressed on tumour cells and tumour-infiltrating immune cells. PD-L1 interacts with PD-1 and B7.1, both found on the surface of T cells, causing inhibition of T cells. By blocking this interaction, Atezolizumab may enable the activation of T cells, restoring their ability to effectively detect and attack tumour cells.
15963212|NCT03164993|Drug|Pegylated liposomal doxorubicin|Chemotherapy
15963213|NCT03164993|Drug|Cyclophosphamide|Chemotherapy
15963214|NCT03164993|Other|Placebo|Placebo
15963215|NCT03164980|Drug|Trabectidin (Yondelis)|To compare QoL in patients treated with trabectedin/PLD vs. other standard combination therapy of carboplatin/ PLD, carboplatin/ gemcitabine, or carboplatin/ paclitaxel
15963216|NCT03164967|Biological|Bivigam|
15963217|NCT03164954|Diagnostic Test|automatic risk detection|automatic alert of the risk for CPSP, triggered by one of the following entries in the hospital information system: psychological risk factors (depression, anxiety, PTSD, catastrophizing, high pain anticipation), chronic use of benzodiazepines or opioids, intense postoperative pain or need of large opioid doses in the recovery room
15963218|NCT03164941|Procedure|Selective Laser Trabeculoplasty|Laser treatment for glaucoma.
15963219|NCT03164928|Drug|Denosumab|1mg/kg BW (up to a maximum of 60 mg) SC Q6M
15963220|NCT03164928|Other|Placebo|SC Q6M placebo
15963221|NCT03164915|Biological|LIV-GAMMA SN Inj.|
15963222|NCT03164902|Device|Digital Medicine|The subjects in the study will be monitored using the Proteus Discover offering. Subjects will use Proteus Discover plus a digital version of HCV therapy (IS co-encapsulated with fixed-dose velpatasvir and sofosbuvir; fixed-dose ledipasvir and sofosbuvir; or fixed-dose glecaprevir and pibrentasvir; or fixed-dose sofosbuvir, velpatasvir, and voxilaprevir). The subject's prescribed HCV medication will be co-encapsulated with the Proteus Ingestible Sensor pill by an appropriately licensed and qualified pharmacy as per a licensed health care provider's order (prescription).
15963223|NCT03164889|Drug|Granulocyte Macrophage-colony Stimulating Factor|The intervention drug was used as an immunomodulator in order to improve rates of HBsAg loss and HBeAg loss.
15963224|NCT03164889|Drug|Entecavir|Antiviral drug for hepatitis b virus (HBV)
15963225|NCT03164876|Drug|AUT00206|4 capsules of 200mg AUT00206, twice daily, to take orally with food for 4 weeks
15963226|NCT03164876|Drug|Placebo|4 capsules of placebo, twice daily, to take orally with food for 4 weeks
15963227|NCT03164863|Diagnostic Test|Onco4D Biodynamic Chemotherapy Selection Assay|The Onco4D Biodynamic Chemotherapy Selection Assay uses Motility Contrast Tomography (MCT) to measure ex-vivo fresh tumor biopsy response when challenged by an array of chemotherapeutic agents. A machine learning algorithm uses the MCT datastream to predict in vivo tumor response or non response to chemotherapy.
15963228|NCT03164850|Device|Laparoscopic Tactile Imaging|Provides Tactile feedback during laparoscopic surgery
15963229|NCT03164837|Drug|68Ga-NOTA-RM26|Single-dose 68Ga-NOTA-RM26 were injected into the patients before the PET/CT scans.
15963230|NCT03164824|Other|questionnaire|"Cross-cultural adaptation stage:
~The FRI was cross-culturally adapted to Thai (called the Thai FRI) and the pre-final version of the Thai FRI was administered to patients.
~Psychometric properties testing stage:
~The questionnaires were administered 3 times: the first visit, the second visit and at 2 weeks.
~At the first visit: the patients with back pain completed the Thai FRI , Thai Roland-Morris Disability (Thai RM), Thai modified Oswestry Low Back Pain Disability (Thai modified ODQ), Thai multi-level Roland-Morris Disability (Thai multi-level RM). The patients with neck pain completed the Thai FRI and Thai Neck Disability Index.
~At the second visit: all patients completed the Thai FRI and Global Perceived Effect Scale (GPES).
~At 2 weeks: the patients completed the same questionnaires as the first visit. All patients and their treating physical therapists completed the GPES."
15963231|NCT03164811|Procedure|goal directed fluid therapy|pulse pressure variation will be used to as a goal to guide fluid administration in this group
15963232|NCT03164811|Other|Controlled|standard fluid treatment by an anesthesiologist
15963233|NCT03164798|Procedure|Conventional inpatient rehabilitation|comprehensive inpatient rehabilitation for 2 weeks
15963234|NCT03164785|Drug|Jinshuibao Capsule|1.98g t.i.d. p.o. for 6 months
15963235|NCT03164772|Drug|Durvalumab|anti-PD-L1
15963236|NCT03164772|Drug|Tremelimumab|anti-CTLA-4
15963237|NCT03164772|Biological|BI 1361849|mRNA Vaccine
15963238|NCT03164746|Other|Dry sheet Therapeutic body wraps|At the beginning of the session, the patient's consent to proceed was orally obtained, as no session was compulsory. The therapists checked behavioral manifestations of refusal. Then, the patient was first wrapped in Dry damp sheets (cold phase) and covered up with a rescue and a dry blanket. Afterward the body spontaneously warmed up (warm phase). The patient was then invited to freely express his feelings.
15963273|NCT03164538|Behavioral|Diabetes Education|Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments.
15963239|NCT03164746|Other|WET sheet Therapeutic body wraps|At the beginning of the session, the patient's consent to proceed was orally obtained, as no session was compulsory. The therapists checked behavioral manifestations of refusal. Then, the patient was first wrapped in wet damp sheets (cold phase) and covered up with a rescue and a dry blanket. Afterward the body spontaneously warmed up (warm phase). The patient was then invited to freely express his feelings.
15963240|NCT03164733|Other|incubation|standardized wear particles are co-incubated with isolated patient cells (monocytes)
15963241|NCT03164707|Diagnostic Test|Blood Glucose Level|ON Admission Blood Glucose Level Fasting Blood Glucose Level
15963242|NCT03164694|Drug|Apatinib|Apatinib was given 850 mg per day orally.
15963243|NCT03164694|Drug|Pemetrexed|pemetrexed (500 mg/m2)
15963244|NCT03164694|Drug|Carboplatin|carboplatin (AUC =5)
15963245|NCT03164668|Other|menthol flavored e-cigarette|menthol flavored e-cigarette
15963246|NCT03164668|Other|tobacco flavored e-cigarette|tobacco flavored e-cigarette
15963247|NCT03164655|Drug|Oxaliplatin, Cetuximab, Bevacizumab, Panitumumab, Irinotecan, Leucovorin, 5-Fluorouracil|Oxaliplatin 100 mg/m² infusion in 2 hours, Cetuximab 500mg/m² infusion in 2 hours, Bevacizumab 5 mg/kg infusion in 30 minutes, Panitumumab 6 mg/kg, Irinotecan 180 mg/m² over 90 minutes to begin 30 minutes after folinic acid infusion is started, Leucovorin 400 mg/m² infusion in 2 hours, 5-Fluorouracil 2400 mg/m² infusion continuous in 46h
15963248|NCT03164642|Behavioral|LENA with Feedback|The LENA with Feedback intervention will involve mothers running the Language ENhancement Assessment/intervention system, an audiorecorder language pedometer that records adult speech centered on the child, child vocalizations, and parent-child reciprocal turn-taking conversations. During their regular EI providers will use a standardized feedback protocol that includes emphasizing the mother's strengths, reviewing the LENA visual output from the previous recording, and asking questions to elicit how the mother can increase her child-centered and reciprocal communications during daily routines. The conversation will include concrete examples of how the mother can increase the language exchanges, encouragement, and practical ways to individually tailor the strategies to the family.
15963249|NCT03164642|Behavioral|LENA no feedback|The LENA with Feedback intervention will involve mothers running the Language ENhancement Assessment/intervention system, an audiorecorder language pedometer that records adult speech centered on the child, child vocalizations, and parent-child reciprocal turn-taking conversations
15963250|NCT03164629|Device|cone-beam CT 3D Emboguide|cone-beam CT with Embolization Guidance software (Emboguide) to identify prostatic arteries and assist endovascular navigation, by projecting a 3D road map of prostatic arteries on live fluoroscopy, in order to differentiate them from non-target vessels.
15963258|NCT03164603|Drug|NLG802|Indoleamine 2,3-Dioxygenase (IDO) Inhibitor
15963259|NCT03164590|Drug|Ketamine|patients receive local anesthetic wound infiltration with 1 mg /kg ketamine
15963260|NCT03164590|Drug|dexmedetomidine|patients receive local anesthetic wound infiltration with 1µg/kg dexmedetomidine
15963261|NCT03164590|Drug|bupivacaine|patients receive local anesthetic wound infiltration with bupivacaine 0.5 % diluted in 20 ml saline
15963262|NCT03164577|Behavioral|Drum-Assisted Recovery Therapy for Native Americans (DARTNA)|An intervention that utilizes AI/AN drumming as its core component of treatment.
15963263|NCT03164577|Other|Usual Care Plus|Participants randomized to usual care plus will participate in activities for approximately the same amount of time as DARTNA participants. They will engage in health and wellness education session once weekly for 6 weeks. They will also receive care for their alcohol and other drug use, This typically consists individual counseling, group therapy, and AI/AN traditional activities in their community.
15963264|NCT03164564|Drug|Oral CAB|CAB 30 mg tablet
15963265|NCT03164564|Drug|Oral TDF/FTC|TDF/FTC 300 mg/200 mg fixed dose combination tablet
15963266|NCT03164564|Drug|Placebo for oral CAB|Placebo tablets
15963267|NCT03164564|Drug|Placebo for oral TDF/FTC|Placebo tablets
15963268|NCT03164564|Drug|CAB LA|600 mg administered as one 3 mL (600 mg) intramuscular injection in the gluteal muscle
15963269|NCT03164564|Drug|Placebo for CAB LA|Administered as one 3 mL intramuscular injection in the gluteal muscle
15963270|NCT03164551|Device|GERI+ incubator|The embryo culture of consented participants were carried out in GERI+ incubator for both bright-field and dark-field time lapse monitoring until Day 3 of embryo culture. On Day 3, all embryos were reviewed firstly by GERI Assess software, using bright-field imaging. Finally the embryo(s) with the highest EEVA grade are transferred were followed up until the achievement of implantation and confirmation of pregnancy.
15963271|NCT03164551|Device|Conventional incubator|The embryo culture of consented participants were carried out in conventional incubator for culture until Day 3 of embryo culture. On Day 3 of embryo culture, all embryos are assessed using a bench-top microscope. The embryo(s) with optimal cell stage and grade were transferred and were followed up until the achievement of implantation and confirmation of pregnancy.
15963272|NCT03164538|Behavioral|Positive Psychology + Motivational Interviewing|Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instructions and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 16 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions. PP and MI components will be delivered stepwise within sessions (rather than intertwined).
15963274|NCT03164525|Diagnostic Test|Critical care pain observation tool (CPOT)|test validity and reliability of Thai-version CPOT and BPS
15963275|NCT03164512|Drug|Oral or vaporized cannabidiol|Acute drug exposure
15963276|NCT03164512|Drug|Placebo|Placebo capsule/vapor
15963277|NCT03164499|Behavioral|Individual counselling on lifestyles|Individual standardized counselling on healthy diet, daily physical activity, stress management, smoking cessation, and moderation in alcohol consumption.
15963278|NCT03164499|Behavioral|Additional group counselling on lifestyles|"Group sessions focusing on cardiovascular risk, diet and moderation in alcohol consumption, physical activity and stress management, and smoking cessation will be held in health centres for four consecutive weeks. Each session will last 60-90 minutes, and will be led by two trained nurse practitioners. Ten participants will assist each group. During each session, attendance will be recorded and printed educational materials related to the topic addressed will be distributed.
~Follow-up calls to reinforce lifestyle modification and record the barriers to behaviour change found will be performed 6 and 9 months after enrolment."
15963279|NCT03164486|Drug|18F-αvβ6-BP|Subjects will be injected once with up to 10 mCi of 18F-αvβ6-BP as a rapid intravenous bolus (within 30 seconds).
15963280|NCT03164473|Drug|Rituximab|pre-emptive 500-mg fixed-dose of IV rituximab every 6 months (total duration of 18 months = 4 infusions)
15963281|NCT03164473|Drug|Azathioprine|oral tablets : 2 mg/kg/day for 24 months
15963282|NCT03164473|Drug|Placebo-rituximab|4 infusions for 18 months
15963283|NCT03164473|Drug|Placebo-azathioprine|oral tablets for 24 months
15963284|NCT03164460|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT/IMPT
15963285|NCT03164460|Radiation|Proton Radiation|Undergo IMRT/IMPT
15963286|NCT03164460|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15963287|NCT03164447|Biological|UB-421|Monoclonal antibody by IV infusion
15963288|NCT03164447|Drug|Optimized background therapy (OBT)|The prescribed OBT must contain at least one agent to which the participant's virus is known to be fully sensitive.
15963289|NCT03164421|Drug|N-Acetylcysteine|N-Acetylcysteine in clomiphene resistant pcos women
15963290|NCT03164421|Drug|L-carnitine|L-carnitine in clomiphene resistant pcos women
15963291|NCT03164408|Procedure|Orthopaedic Implant Removal|
15963292|NCT03164395|Procedure|Internal Cardioversion|Internal Cardioversion with device maximum output shock from RV coil to Can versus external cardioversion per institutional protocol
15963293|NCT03164395|Procedure|External Cardioversion|External Cardioversion per institutional protocol
15963294|NCT03164382|Drug|FOLFOX regimen|Firstly, the femoral artery was percutaneously punctured using the Seldinger technique. Then, the catheter was inserted into the celiac trunk or superior mesenteric artery for arteriography. When more than one feeding artery of HCC was detected, the smaller arteries were embolized with gelatin sponge particles. A micro-catheter was inserted through the arterial catheter located at the common hepatic artery or proper hepatic arterial branch (feeding artery). When blood flows into the gastroduodenal artery was confirmed by micro-catheter angiography, the route was embolized with a coil or micro-coil to prevent reflux of chemotherapeutic drugs to the stomach and duodenum. The peripheral part of the catheter that was exposed to the outside of the body was covered with medical sterile gauze and fastened on the thigh's skin using medical rubberized fabric and bandage. Catheter insertion was repeatedly performed before every cycle of treatment.
15963295|NCT03164382|Drug|Sorafenib 200Mg Tab|Sorafenib will be administered orally at the starting dose of 400 mg twice daily (800 mg total daily dose) to patients randomized to Arm S in accordance to its package insert or equivalent documentation. The 400 mg dose will be achieved by administration of 2 x 200 mg film-coated tablets, administered twice daily.
15963296|NCT03164356|Other|Socket Modification Regime|Data obtained from the arm 1 cohort will be used to inform socket modifications made for arm 2 cohort.
15963297|NCT03164343|Device|Pain Neuroscience Education for children|Children and their parent will receive a +/- 1h one-on-one educational session about the neurophysiology of pain, adjusted to the child's comprehension status. Parents will be present in the PNE session too. The PNE program for children contains two sections: (1) The healthy pain system and its function, divided in subsections each consisting of a specific neurophysiological pain concept (i.e. central nervous system anatomy, nociception and nociceptive pathways, up- and down-regulation of the nervous system) and (2) adaptations of the pain system following persistent pain. To ensure interaction between therapist and child, an interactive board game was developed and used throughout the full educational session.
15963298|NCT03164330|Behavioral|Workplace Wellness Program|Treatment group members will then be offered the opportunity to participate in a biometric screening and health risk assessment (biometric screening + HRA), and -- conditional on completing an biometric screening + HRA -- up to two, semester-long wellness programs. Treatment group members will be offered varying levels of cash reward for completing the biometric screening + HRA (none, moderate, high), and an additional cash reward for completing each wellness activity (low, high), for a total of 6 treatment cells. Follow-up surveys and biometric screenings will be administered one year later, among a subset of control and treatment group members.
15963299|NCT03164330|Behavioral|Biometric Screening/HRA - No Compensation|The biometric test will measure: (1) anthropometrics such as height, weight, and waist circumference (to assess obesity and overweight status); (2) resting blood pressure (to assess hypertension); (3) blood glucose (to assess diabetes risk); and (4) total, LDL, and HDL cholesterol levels, total cholesterol ratio, and triglycerides (to assess risk of cardiovascular disease). The HRA is a survey designed to identify areas of health improvement, by asking a series of questions related to wellness, health status, nutrition, healthy activities, desire to improve health, preventative health measures. The HRA is also pre-populated with biometric information from the screening. Upon completion, participants are given customized feedback on areas of improvement. No compensation for completion.
15963325|NCT03164122|Drug|injection of microfat and plasma rich platelet PRP|intra-articular injections
15963326|NCT03164122|Device|MRI|MRI 3T
15963327|NCT03164109|Drug|GC4419 IV|50mg infused IV over 15 minutes
15963328|NCT03164109|Drug|Placebo|Infused IV over 15 minutes
15963329|NCT03164109|Drug|Oral moxifloxacin|400 mg tablet orally with 250 mL room temperature water
15963330|NCT03164096|Drug|Bupivacaine Hydrochloride|intrathecal bupivacaine will be used for spinal anesthesia in obstetric patients undergoing C-section
15963798|NCT03160508|Procedure|Fracture fixation with the TFNA|Fracture fixation with the TFNA
15963300|NCT03164330|Behavioral|Biometric Screening/HRA - Moderate Compensation|The biometric test will measure: (1) anthropometrics such as height, weight, & waist circumference (to assess obesity and overweight status); (2) resting blood pressure (to assess hypertension); (3) blood glucose (to assess diabetes risk); & (4) total, LDL, and HDL cholesterol levels, total cholesterol ratio, and triglycerides (to assess risk of cardiovascular disease). The HRA is a survey designed to identify areas of health improvement, by asking a series of questions related to wellness, health status, nutrition, healthy activities, desire to improve health, preventative health measures. The HRA is also pre-populated with biometric information from the screening. Upon completion, participants are given customized feedback on areas of improvement. Moderate compensation for completion.
15963301|NCT03164330|Behavioral|Biometric Screening/HRA - High Compensation|The biometric test will measure: (1) anthropometrics such as height, weight, and waist circumference (to assess obesity and overweight status); (2) resting blood pressure (to assess hypertension); (3) blood glucose (to assess diabetes risk); and (4) total, LDL, and HDL cholesterol levels, total cholesterol ratio, and triglycerides (to assess risk of cardiovascular disease). The HRA is a survey designed to identify areas of health improvement, by asking a series of questions related to wellness, health status, nutrition, healthy activities, desire to improve health, preventative health measures. The HRA is also pre-populated with biometric information from the screening. Upon completion, participants are given customized feedback on areas of improvement. High compensation for completion.
15963302|NCT03164330|Behavioral|Wellness Activities - Low Compensation|Courses are designed by the UI Wellness Center and include an Active Living class; self-paced online health challenges in physical activity, weight management, and healthy eating; a weight management class; a tobacco cessation hotline; a stress management class; a Tai Chi class; and a chronic disease management class. Low compensation for each class.
15963303|NCT03164330|Behavioral|Wellness Activities - High Compensation|Courses are designed by the UI Wellness Center and include an Active Living class; self-paced online health challenges in physical activity, weight management, and healthy eating; a weight management class; a tobacco cessation hotline; a stress management class; a Tai Chi class; and a chronic disease management class. High compensation for each class.
15963304|NCT03164317|Other|Intervention|A trained nurse care coordinator enabled with a electronic decision support system placed at the CHCs to share the task of management of hypertension.
15963305|NCT03164317|Other|Control|No NCC or EDSS will be placed in the CHCs. Doctors working in the CHCs will be given training (one day) on evidence based management of hypertension
15963306|NCT03164304|Drug|Magnesium Sulfate|intravenous
15963307|NCT03164291|Drug|Rifabutin|Rifabutin dosage dependent on clinical factors such as age, weight, and patient-specific health status
15963308|NCT03164278|Behavioral|Independent Transfer Training|Independent Transfer Training Program: ITTP training starts with an overview and self-evaluation using the transfer assessment instrument questionnaire (TAI-Q) followed by three core modules: wheelchair setup, body setup, and flight/landing. Wheelchair setup includes factors such as the angle and distance of the wheelchair to the transfer surface, removing barriers, applying the brakes, and height of the transfer. Body setup involves positioning one's body for an optimal transfer and covers foot, hip, arm and hand positions. Flight/landing discusses how to achieve a smooth and controlled transfer, the head-hips relationship, use of transfer device, and safe landing.
15963309|NCT03164265|Biological|Regulatory Donor-Derived Dendritic Cell infusion|Regulatory dendritic cells that were prepared from a donor leukapheresis will be infused into liver transplant recipients 7 days prior to surgery
15963310|NCT03164252|Radiation|Grupo I- Lower laser fluency|The region determined for the application of the laser will be 4 points of the gingival mucosa: 1 - center of the alveolus; 2- center of the cervical third of the lingual face; 3 - lingual face; And 4 - apical third of the lingual face. The application time of the laser will be divided equally between the four points of application.
15963311|NCT03164252|Radiation|Grupo II- Greater laser fluency|The region determined for the application of the laser will be 4 points of the gingival mucosa: 1 - center of the alveolus; 2- center of the cervical third of the lingual face; 3 - lingual face; And 4 - apical third of the lingual face. The application time of the laser will be divided equally between the four points of application.
15963312|NCT03164252|Radiation|Grupo III- Laser sham|The region determined for the application of the laser will be 4 points of the gingival mucosa: 1 - center of the alveolus; 2- center of the cervical third of the lingual face; 3 - lingual face; And 4 - apical third of the lingual face. The application time of the laser will be divided equally between the four points of application.
15963313|NCT03164239|Behavioral|Intervention group - telephone and print exercise intervention|Intervention has previously been described.
15963314|NCT03164226|Device|Digital plethysmography in the diagnosis of Acute Coronary Syndrome|To verify the contribution of digital plethysmography in the early diagnosis of acute coronary syndrome in emergency departments.
15963315|NCT03164213|Device|experimental: tDCS|The anode will be placed over the left M1 representation of the hand (C3 of the 10-20 EEG system). Twenty minutes of anodal-tDCS (1mA) will be administered at the beginning of the daily treatment session. Following the stimulation will be 45 minutes of naming therapy.
15963316|NCT03164213|Device|sham tDCS|"The anode will be placed over the left M1 representation of the hand (C3 of the 10-20 EEG system). Twenty minutes of sham-tDCS will be administered at the beginning of the daily treatment session.
~During sham-tDCS, the current will be ramped up and remained at 1mA only for 30 s before ramping down, which does not affect neural functions, but assures effective blinding of participants due to the initial tingling sensation on the scalp. Following the sham stimulation will be 45 minutes of naming therapy."
15963317|NCT03164200|Other|High fat breakfast|High fat breakfast
15963318|NCT03164200|Other|Higher carbohydrate breakfast|Higher carbohydrate breakfast
15963319|NCT03164187|Drug|Diabeton 60 MR|Administer Diabeton MR 60 mg 1/2 tablet. Increasing dosage of Diabeton MR 60 mg by ½ tablet is recommended if fasting glucose level exceeds 6 mmol/L.
15963320|NCT03164161|Device|Cold pressor test|Described before.
15963321|NCT03164161|Other|β-endorphins evaluation in saliva|Described before.
15963322|NCT03164161|Other|β-endorphins evaluation in blood plasma|Described before.
15963323|NCT03164148|Device|T-REX TRI00A|Case management consists of confirmation of hospital visit date, checking the adverse effect
15963324|NCT03164135|Genetic|CCR5 gene modification|CD34+ hematopoietic stem/progenitor cells from donor are treated with CRISPR/Cas9 targeting CCR5 gene.
15963331|NCT03164083|Biological|Mesenchymal stem cell|intra articular injection of mesenchymal stem cell Other Name: stem cell transplantation
15963332|NCT03164083|Biological|Placebo|Patients with knee joint osteoarthritis who underwent intra articular placebo injection
15963333|NCT03164057|Drug|Azacitidine|Azacitidine solution is administered intravenously (IV) over a period of 10-40 minutes.
15963334|NCT03164057|Drug|Decitabine|Administered intravenously (IV) over approximately one hour.
15963335|NCT03164057|Drug|Cytarabine|Given IV or intrathecally (IT).
15963336|NCT03164057|Drug|Daunorubicin|Given IV.
15963337|NCT03164057|Drug|Etoposide|Given IV.
15963338|NCT03164057|Combination Product|ITMHA|Given IT.
15963339|NCT03164057|Drug|Idarubicin|Given IV.
15963340|NCT03164057|Drug|Fludarabine|Given IV over approximately 30 minutes.
15963341|NCT03164057|Drug|Mitoxantrone|Given IV.
15963342|NCT03164057|Drug|Erwinia asparaginase|Given IV or intramuscularly (IM).
15963343|NCT03164057|Drug|Sorafenib|Given PO.
15963344|NCT03164057|Drug|G-CSF|Given IV.
15963345|NCT03164057|Drug|Dexrazoxane|Given IV immediately before idarubicin administration.
15963346|NCT03164057|Biological|Stem Cell Transplant|The transplant protocol will depend on the patient's donor and transplant physician's preference.
15963347|NCT03164031|Device|Close-fitting orthotic shorts|The orthotic shorts will be custom-made by DM Orthotics, a UK based company that specialises in dynamic, elastomeric orthoses for healthcare and sport. They will provide both pairs of shorts for each participant, both constructed from a 275 g/m2 fabric, which is 51% Polyamide, 32% Dorlastan and 17% cotton. A company representative will assess each participant to decide the compression and fit of the shorts, such as whether support for the lower trunk is required. The shorts can be manufactured with a toileting hole, if preferred, allowing participants to toilet without removing the shorts. Shorts with a toileting hole are worn beneath usual underwear.
15963348|NCT03164031|Device|Looser fitting shorts|Looser fitting shorts will be custom-made by DM Orthotics, a UK based company that specialises in dynamic, elastomeric orthoses for healthcare and sport. Shorts will be constructed from a 275 g/m2 fabric, which is 51% Polyamide, 32% Dorlastan and 17% cotton. A company representative will assess each participant to decide the fit of the shorts. The shorts can be manufactured with a toileting hole, if preferred, allowing participants to toilet without removing the shorts. Shorts with a toileting hole are worn beneath usual underwear.
15963349|NCT03164018|Drug|Fampridine|The non-interventional design allows the observation of patients in a broad range of settings reflecting routine clinical practice. All decisions on therapeutic or diagnostic procedures, treatments and management of the disease will be at the full discretion of the treating physician without interference by a sponsor or study protocol. All treatment decisions will follow the real-life treatment behavior.
15963350|NCT03163992|Drug|Pembrolizumab|Pembrolizumab (MK-3475) 200 mg every 3 weeks (Q3W)
15963351|NCT03163979|Biological|18F-FDG PET/CT and Comet assay guide RapidArc|1.A Rapid-Arc plan for cancer of the cervix uteri improved the sparing of organs at risk (OARs) with uncompromised target coverage. 2.Based on FDG-PET/CT and comet analysis, higher doses of irradiation can be delivered to low sensitivity tumor region, so as to achieve individualized treatment.
15963352|NCT03163979|Biological|18F-FDG PET/CT and Comet assay guide IMRT|Based on FDG-PET/CT and comet analysis, higher doses of irradiation can be delivered to low sensitivity tumor region, so as to achieve individualized treatment.
15963353|NCT03163979|Biological|RapidArc|"RapidArc:
~A maximum DR of 600 MU/min was set for comparing the 7f-IMRT treatment time. Two 360° coplanar arcs (one clockwise arc rotated from 181° to 179° and the other counter-clockwise arc rotated from 179° to 181°) sharing the same isocentre were used."
15963354|NCT03163979|Biological|7f-IMRT|seventy-five patients received IMRT. The 7f-IMRT gantry angles were 0°, 51°, 102°, 153°, 204°, 255° and 306°, with 20 intensity levels and a dose rate of 400 monitor units (MU)/min. Doses were delivered using the step-and-shoot method.Conventional fractionation was used in all patients for a total dose 45-50.4 Gy with 6 MV high-energy photons.
15963355|NCT03163966|Drug|CR6086|oral CR6086 capsules
15963356|NCT03163966|Drug|Methotrexate|oral Methotrexate tablets
15963357|NCT03163966|Drug|Placebo|oral CR6086 Placebo capsules
15963358|NCT03163953|Behavioral|TPAG with long break|PA coaching based on Thai Physical Activity Guideline (TPAG) and long break or break 15 minutes for every 2 hours (TPAG with LB)
15963359|NCT03163953|Behavioral|TPAG with short break|PA coaching based on TPAG and short break or break 1-2 minutes for every 1 hours (TPAG with SB)
15963360|NCT03163953|Other|Control|No intervention
15963361|NCT03163940|Behavioral|Laughter Yoga|A LY group will be composed of 8-12 participants. Each sessions will include 4 essential elements steps of laughter yoga, laughter meditation and grounding exercises. The 4 steps of laughter yoga are 1) warm up exercise, 2) deep breathing exercises, 3) childlike playfulness and 4) laughter exercises. The laughter meditation is a deeper experience of unconditional laughter in which laughter often comes in natural waves and it becomes infectious and set off a chain reaction to infect other people. The grounding exercises allow individuals to ground the energy of laughter and relax. The LY intervention will be facilitated by a certified lead LY trainer.
15963362|NCT03163927|Other|Simulation-based training|See arm description
15963363|NCT03163914|Drug|Epinephrine|Epinephrine infusion rate will adjust 30 ml/h (5µg/ ml )
15963364|NCT03163914|Drug|Norepinephrine|Norepinephrine infusion rate will adjust 30 ml/h (5µg/ ml )
15963365|NCT03163914|Drug|Phenylephrine|Phenylephrine infusion rate will adjust 30 ml/h (100µg/ ml )
15963366|NCT03163914|Drug|Saline|saline infusion will apply till the end of the surgery
15963367|NCT03163901|Other|Osteopathic Manipulative Treatment|OMT techniques applied in the thoracic spine soft tissue, cervical spine soft tissue, suboccipital release, occipital condyle condylar decompression, and cranial venous sinus release.
15963368|NCT03163888|Procedure|Navigation TKR|Traditional over Conventional TKR
15963369|NCT03163875|Other|Hospital Anxiety and Depression Scale|To assess the levels of depression and anxiety, quality of sleep and quality of life (QoL) in chronic urticaria patients, using an interdisciplinary approach combining interview/questionnaire-based psychiatric and dermatological evaluations
15963401|NCT03163641|Device|Ocular Bandage Gel|0.75% crosslinked HA
15963799|NCT03160495|Other|All patients|All patients are scanned with PET/MR prior to surgery.
15963370|NCT03163862|Procedure|Endometrial scratch|the intervention group, endometrial biopsy will be performed with a pipelle de Cornier® (Laboratoires Prodimed, Neully-En-Thelle, France). The pipelle was introduced gently through the cervix up to the uterine fundus. the examiner applied regular back-and-forth movements (2-4 cm) during a period of 30 s. The obtained specimens will be sent for histology evaluation.
15963371|NCT03163862|Drug|G-CSF administration|1- 300 µg trans cervical intrauterine of G-CSF was administered at the oocyte retrieval day, subcutaneous 300 micrograms G-CSF on the day of embryo transfer
15963372|NCT03163862|Drug|Saline Solution|saline infusion every day from the day of embryo transfer through the day of beta HCG test
15963373|NCT03163849|Drug|Sofosbuvir , daclatasvir|Tablets
15963374|NCT03163849|Drug|Placebos|oral tablets
15963375|NCT03163836|Procedure|double valve replacement|After median sternotomy, cardiopulmonary bypass was established via bicaval and aortic cannulation. After cross-clamping of the aorta and cardioplegia, mitral and aortic replacement were performed. Supplementary procedures such tricuspid annuloplasty, ascending aorta replacement and coronary artery bypass grafting were performed as required. The left atrial appendage was excised to avoid thrombus formation.
15963376|NCT03163836|Procedure|surgical ablation|Both left and right atrial ablation were performed using a bi-polar radiofrequency ablation clamp.
15963377|NCT03163823|Other|Proloquo2Go|Use of communication application Proloquo2Go modified for the ICU setting on an iPad device
15963378|NCT03163823|Other|Standard of Care|Standard of Care communication methods
15963379|NCT03163810|Device|Erchonia Verju Laser|The Erchonia Verju Laser is applied 2 times a week to the front and back of the waist, hips and upper abdomen for 30 minutes each time over 8 to 12 weeks.
15963380|NCT03163810|Device|Erchonia EVRL Laser|The Erchonia EVRL Laser is applied under the right ribcage angled towards the liver for 10 minutes, one time per week over the same 8 to 12 weeks as the Verju Laser is administered.
15963381|NCT03163797|Diagnostic Test|PET/MRI for evaluation|Before pretreatment, each enrolled patients will undergo PET/MRI and detail clinical examination, including human papillomavirus test. They will also undergo low dose chest CT on the same day before PET/MRI. In the posttreatment period, baseline whole body MRI will be obtained 3 months after chemoradiation. Thereafter, the patients will then be followed up also with alternative extend-field CT and whole body MRI by every 6 months. If tumor recurrence is confirmed or highly suspected, PET/MRI will also be performed for tumor re-staging.
15963382|NCT03163784|Biological|Fecal Inoculum Capsule|Sieved fecal matter prepared in glycerol/saline solution
15963383|NCT03163784|Biological|Placebo (for Fecal Inoculum Capsule)|Placebo capsule manufactured to mimic Fecal Inoculum Capsules
15963384|NCT03163784|Drug|Antibiotic|Antibiotic pre-treatment
15963385|NCT03163784|Drug|Antibiotic Placebo|Placebo tablets manufactured to mimic antibiotics
15963386|NCT03163758|Device|real Repetitive Transcranial Magnetic Stimulation|The rTMS treatments were performed using a Medtronic MagPro type magnetic stimulation device (Medtronic, Minneapolis, MN, USA) and a figure-of-eight coil (MC-B70, Medtronic). Coils were placed tangent to the scalp. The stimulation protocol involved 50 trains of 20 pulses applied over the ipsilesional M1 at a frequency of 5 HZ, with the stimulus intensity set at 120% of the resting motor threshold of the unaffected extremity.
15963387|NCT03163758|Device|sham Repetitive Transcranial Magnetic Stimulation|The sham rTMS was performed on the same site as the rTMS treatment group but without any true stimulations. Coils were placed perpendicular to the scalp.
15963388|NCT03163745|Procedure|paracentesis|paracentesis will be done for all patient for ascitic fluid study and ascitic fluid culture
15963389|NCT03163732|Genetic|Blood and tumor samples|Evaluation of the added value of a large molecular profiling panel versus a limited molecular profiling panel
15963390|NCT03163719|Diagnostic Test|CK and Lactate dosages|"A patient consulting the emergency department for suspected seizure will have an usual blood test at the admission in this context with notably ionogram, fasting glucose, venous gasometry. As the CHU purchased a venous and arterial gasometry reader for the emergency department, blood ionogram, Hb, lactates, HCO3-, pH are collected without delay. The Creatine kinase dosage will be collected in the usual way as a tube bottom. As recommended by the French Society of Neurology, a new sample will be collected at 4 hours of seizure for a dosage of Creatine kinase. The determination of the lactates will be based on a tube bottom."
15963391|NCT03163706|Behavioral|Modified Stroop effect|to assess whether attention deficits and executive functions in patients with schizophrenia are general (semantic and response conflict) or specific (semantic or response conflict).
15963392|NCT03163693|Drug|dexmedetomidine|receive dexmedetomidine 0.5 μg/kg
15963393|NCT03163693|Other|normal saline|receive equal volume of normal saline
15963394|NCT03163680|Drug|Omeprazole 40 MG|Omperazole 40 mg twice daily
15963395|NCT03163667|Drug|Placebo|oral tablets
15963396|NCT03163667|Drug|CB-839|oral tablets
15963397|NCT03163667|Drug|everolimus|oral tablets
15963398|NCT03163654|Procedure|Surgery 1|Following local anaesthesia (Articaine hydrochloride 4% with 1:200,000 epinephrine injection) administration, sulcular incisions were made in the recession's areas of teeth without damaging interdental papilla. Mucoperiosteal (MP) dissections were made using the periostal elevator creating the deep pouch beyond the mucogingival junction so that the (MP) flap could be moved coronally without tension. Porcine-derived acellular dermal collagen matrix (PADM) was positioned at the level of a cemento-enamel junction (CEJ) and skin tight for teeth to avoid forming a blood clot. Separate single sutures per tooth with 5-0 resorbable suture were used to stabilise graft. The tunnel flap was positioned coronally above the CEJ to completely cover the graft and sutured with non-resorbable polypropylene suture.
15963399|NCT03163654|Procedure|Surgery 2|Following local anaesthesia (Articaine hydrochloride 4% with 1:200,000 epinephrine injection) administration, sulcular incisions were made in the recession's areas of teeth without damaging interdental papilla. Mucoperiosteal (MP) dissections were made using the periostal elevator creating the deep pouch beyond the mucogingival junction so that the (MP) flap could be moved coronally without tension. Connective tissue graft was positioned at the level of a cemento-enamel junction (CEJ) and skin tight for teeth to avoid forming a blood clot. Separate single sutures per tooth with 5-0 resorbable suture were used to stabilise graft. The tunnel flap was positioned coronally above the CEJ to completely cover the graft and sutured with non-resorbable polypropylene suture.
15963400|NCT03163641|Device|Acuvue Oasys|Bandage Contact Lens
15963402|NCT03163628|Biological|Diagnostic performances of a combination of biomarkers|"3 ml of blood will be drawn at inclusion at the same time of the venipuncture prescribed for standard care. The dosage of the 7 biomarkers will be performed in a central laboratory. The adjudication committee will classify patients in 6 groups, based on their clinical data. The committee will not be aware of the biological results. The analysis of Train Set data will aim to identify the most effective combination of markers in response to the primary objective of identifying biomarkers for the diagnosis of severe bacterial infections. The best combination selected will then be applied to the Test Set data (approximately the other half of patients), in order to obtain its real and unbiased performance.
~The calculation of positive and negative likelihood ratios will be performed.
~The targeted performances are:
~A positive likelihood ratio (LR +) of 5.67 minimum, ideally greater than 8.5.
~A negative likelihood ratio (LR-) of 0.5 maximum, ideally less than 0.3."
15963403|NCT03163615|Drug|Tibet Rhodiola Capsule|4 capsules, po, from admission up to 84 days
15963404|NCT03163615|Drug|Placebo oral capsule|4 capsules, po, from admission up to 84 days
15963405|NCT03163602|Drug|Control group|Access flap and debridement
15963406|NCT03163602|Device|Test group|Regenerative treatment
15963407|NCT03163589|Drug|Erythropoietin|injection
15963408|NCT03163589|Drug|normal saline|injection
15963409|NCT03163576|Drug|Niacin|tablets
15963410|NCT03163576|Drug|Phosphate Binder|tablets
15963411|NCT03163563|Device|Easywarm|Warming blanket
15963412|NCT03163563|Device|BairHugger|Patient warming mattress with continuous warm air.
15963413|NCT03163550|Drug|ACHN-383|Oral dose
15963414|NCT03163550|Drug|ACHN-789|Oral dose
15963415|NCT03163550|Drug|Placebo|Oral dose
15963416|NCT03163537|Device|HealthPatch|Smart patch that is able to measure stress real time using an algorithm between HR and HRV
15963417|NCT03163524|Other|e-Coupon Text Modification and Reminders|The treatment group will receive a modified text of the current e-coupon. They will also receive notification that they have been enrolled in the study via a second text. They will also receive a series of text message reminders to redeem their e-coupons at intervals of 6, 13 and 18 days after coupon origination.
15963418|NCT03163524|Other|e-Coupon standard text|Participants receive control text (SMS) message, which contains a numeric coupon code and no additional text to the standard coupon.
15963419|NCT03163511|Combination Product|VC-02 Combination Product|PEC-01 cells loaded into a Delivery Device
15963420|NCT03163498|Other|No intervantion. It´s a Cross-Sectional Study|No intervential
15963421|NCT03163485|Device|Dialytrode|Multimodal neuromonitoring by intracerebral depth EEG recording combined with microdialysis for the sampling of cerebrospinal fluid during EEG recording
15963422|NCT03163485|Device|Standard treatment|Monitoring of intracranial pressure by EVD and/or multimodal neuromonitoring by microdialysis for sampling of cerebrospinal fluid
15963423|NCT03163472|Procedure|Axillary brachial plexus block with 10 mL oof local anaesthetic|patients will receive axillary brachial plexus block with 10 ml of lidocaine 2% with epinephrine.
15963424|NCT03163472|Procedure|Axillary brachial plexus block with 30 ml of local anaesthetic|patients will receive axillary brachial plexus block with 30 ml of lidocaine 2% with epinephrine.
15963425|NCT03163459|Drug|selective brain cooling by cold saline perfusion|During the procedure, a microcatheter which was used to deploy the stent retriever was threaded into the femoral artery in the groin through a guiding catheter and up through the neck, until it reached beyond the clot causing the stroke under the assistance of micro-guide wire, 50 mL cold 0.9% saline (4°C) was infused into the ischemic territory at 10 mL/min through the microcatheter, thus allowing the cold solution to infuse into the ischemic territory prior to reperfusion. After that, mechanical thrombectomy with a stent retriever was performed to recanalize the occluded vessel as soon as possible. After the recanalization, cold 0.9% saline (4°C) was infused into the ischemic brain tissue through the guide catheter at 30 mL/min for 10 minutes.
15963426|NCT03163459|Device|mechanical thrombectomy|conventional mechanical thrombectomy using Solitaire
15963427|NCT03163446|Biological|CF-301|CF-301, 0.25 mg/kg, given as a single 2 hour iv infusion
15963428|NCT03163446|Drug|Placebo|Placebo, given as a single 2 hour iv infusion
15963429|NCT03163433|Behavioral|Feedback in the consultation|Patients will complete electronic Patient Reported Outcome Measures (PROM) before the consultation at the hospital. The results are fed back to physicians. In the consultation patients will systematically participate in a dialogue with their physician about issues that are most important for the patients.
15963430|NCT03163420|Drug|Diclofenac potassium|Diclofenac potassium 50 mg granules for oral solution
15963431|NCT03163420|Other|Placebo|Fructose
15963432|NCT03163407|Drug|Norepinephrine|Treatment of the postspinal anesthesia hypotension by administrating 5 mcg of Norepinephrine intravenously every 3 min until normal systolic blood pressure
15963433|NCT03163407|Drug|Ephedrine|Management of the post spinal hypotension by administrating 6 mg of Ephedrine intravenously every 3 min
15963434|NCT03163381|Drug|Apatinib|Apatinib 500mg,po,qd,medicine to disease progression.
15963435|NCT03163368|Radiation|Neoadjuvant stereotactic radiosurgery|Dose escalation of neoadjuvant stereotactic radiosurgery
15963436|NCT03163368|Procedure|Neurosurgical resection|Surgical resection of newly diagnosed brain metastases
15963437|NCT03163355|Other|a gelling agent|Pureed rice containing a gelling agent (Softia U, Nutri Co., Ltd., Yokkaichi, Japan) is compared with the standard purred rice in the condition of swallowing.
15963438|NCT03163342|Biological|Licensed seasonal influenza vaccine|20 healthy subjects will be enrolled and receive a single dose of licensed seasonal influenza vaccine
15963439|NCT03163329|Procedure|TAVR|Transcatheter Aortic Valve Replacement
15963440|NCT03163329|Procedure|SAVR|Surgical Aortic Valve Replacement
15963441|NCT03163316|Other|Unenhanced magnetic resonance imaging.|"The axillary lymph nodes will be evaluated on axial Time 1-weighted images obtained without fat saturation. We will measure the largest dimension and cortical thickness of each lymph node and ratio of the two measurements will be calculated.
~The lymph nodes seen in Time 1-weighted images will be subsequently identified on the diffusion-weighted images to calculate the apparent diffusion coefficient value of each lymph node.
~Axillary lymph nodes scanned by magnetic resonance imaging will be compared by results of histopathological examination."
15963823|NCT03160261|Drug|Exenatide Injection|Single injection of Exenatide 10μg subcutaneously
15963442|NCT03163303|Behavioral|Tobacco Status Project Intervention|90 days of Facebook messaging, weekly live sessions targeting tobacco use
15963443|NCT03163303|Behavioral|Tobacco Status Project + Alcohol Intervention|90 days of Facebook messaging, weekly live sessions targeting tobacco use and alcohol use
15963444|NCT03163303|Drug|nicotine patch|14-day supply of nicotine patch
15963445|NCT03163290|Other|Posterolateral Hip Complex Exercises|The treatment protocol was composed of: Heating, lower limb stretching, strengthening the quadriceps e hip muscles. The following exercises were included: abduction exercise, Clam exercise and external rotation exercise
15963446|NCT03163290|Other|Anteromedial Hip Complex Exercises|The treatment protocol was composed of: Heating, lower limb stretching, strengthening the quadriceps e hip muscles. The following exercises were included: hip adduction exercise, adduction with a ring between the thighs and internal rotation exercise.
15963447|NCT03163277|Drug|emtricitabine, darunavir/cobicistat, maraviroc|Treatment change
15963448|NCT03163264|Behavioral|Peer Assisted Lifestyle|Patients will use PAL online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals.
15963449|NCT03163264|Behavioral|Enhanced Usual Care|"Patients will be given information on healthy living messages that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling."
15963450|NCT03163251|Behavioral|READ-SG Sessions|In the Internal Medicine residency program at Columbia University Medical Center, PGY-1 trainees receive an hour of protected time to attend a monthly peer-facilitated small group session, outlined above. PGY-2 and 3 trainees have a similar combined session separate from the PGY-1s. Facilitators are chosen by the READ-SG Committee, which is comprised of Mark P. Abrams (Director, Co-Investigator), Evelyn Granieri (Faculty Advisor, PI), a Chief Resident from the program (Program Liaison), and the facilitators.
15963451|NCT03163238|Drug|Dexmedetomidine|Dexmedetomidine 0.5 mcg/kg diluted with normal saline in Dexmedetomidine group. Second syringe (50 ml) will contain normal saline (0.9%) in addition to Dexmedetomidine in addition to normal saline in Dexmedetomidine group. Concentration of Dexmedetomidine will be diluted according to the body weight so that we will fix the rate of infusion (1 ml/kg) to achieve a concentration of 0.5 mcg/kg/h in Dexmedetomidine group.
15963452|NCT03163238|Drug|Normal saline|One syringe contain normal saline in 5 ml in Saline group. Second syringe (50 ml) will contain normal saline (0.9%) alone in rate of infusion (1 ml/kg) in Saline group
15963453|NCT03163212|Dietary Supplement|Lactoferrin/FOS|Bovine Lactoferrin/FOS 100mg/ml dissolved in sterile water
15963454|NCT03163199|Device|Translesional Hemodynamic Measurement|Measurement of hemodynamics using the NAVVUS catheter during endovascular therapy
15963455|NCT03163186|Procedure|Transarterial embolization|Transarterial hepatic embolization of liver cancer
15963456|NCT03163173|Drug|GC4419|30 mg (~100 μCi) dose of [14C]GC4419
15963457|NCT03163160|Procedure|Pelvic floor manual therapy group|Soft-tissue (myofascial) stretching techniques on pelvic floor muscles through external and internal (intra-vaginal) mobilizations. One weekly session for four weeks.
15963458|NCT03163160|Procedure|Pelvic floor electrolysis group|"An ultrasound-guided application of a galvanic electrolytic current with an acupuncture needle in the soft tissue of pelvic floor. EPI technique was applied using a specifically device (EPI-X Omega Advanced Medicine, Barcelona, Spain) which produces modulated galvanic electricity. This is applied using a modified electrosurgical scalpel that incorporates acupuncture needles (0.3 mm in diameter) of different lengths. The intensity can be adjusted by changing either the duration of stimulation or the output current (mA) of the device.
~One weekly session for four weeks."
15963459|NCT03163134|Device|Lumbar Drain|
15963460|NCT03163121|Biological|PfSPZ-GA1 Vaccine|Aseptic, purified, cryopreserved, genetically attenuated P. falciparum sporozoites (Pf∆b9∆slarp), strain NF54
15963461|NCT03163121|Biological|PfSPZ Vaccine|Aseptic, purified, cryopreserved, radiation attenuated P. falciparum sporozoites (PfSPZ Vaccine), strain NF54
15963462|NCT03163121|Other|Normal Saline|0.9% sodium chloride
15963463|NCT03163121|Biological|Mosquito-bite CHMI|Bites of 5 infected mosquitoes of NF54 strain
15963464|NCT03163108|Device|Closed-loop automatic oxygen control (CLAC) fast in addition to RMC|Closed-loop automatic oxygen control is an automated, algorithm based adjustment of the fraction of inspired oxygen in relation to arterial saturation (WAIT-interval 30s).
15963465|NCT03163108|Device|Closed-loop automatic oxygen control (CLAC) slow in addition to RMC|Closed-loop automatic oxygen control is an automated, algorithm based adjustment of the fraction of inspired oxygen in relation to arterial saturation (WAIT-interval 180s).
15963466|NCT03163095|Device|Open Abdomen Management with ANPPT dressing|"The abdominal fascia will not be closed, but a temporally abdominal closure (TAC) dressing, such as AbThera dressing, will be placed to protect the viscera with active Negative Pressure Peritoneal Therapy.
~The time that the TAC dressing will be changed will be left to the discretion of the attending surgeon, but practice guidelines mandate either formal abdominal closure or dressing change at 24-72 hours from placement.
~Blood samples and peritoneal fluid will be drawn up to 72 hours after enrollment."
15963467|NCT03163095|Other|Closed Abdomen Management|"Primary closure of the abdominal fascia with placement of an intra-peritoneal drain (such as a Jackson-Pratt drain).
~This strategy will allow drainage of intra-peritoneal fluid for both clinical reasons and to facilitate intra-peritoneal fluid testing. Closure or not of the skin will be left to the attending surgeons discretion. Any decision to perform a relaparotomy (Relaparotomy on Demand) will be at the discretion of the treating critical care teams, and in no way mandated by this recruitment.
~Blood samples and peritoneal fluid (if available) will be drawn up to 72 hours after enrollment."
15963468|NCT03163082|Other|Cognitive Intervention|The cognitive intervention has partners come up with reasons why their partners do things they don't like, until they come up with benign attributions for those behaviors.
15963469|NCT03163082|Behavioral|Behavioral Intervention|The behavioral intervention has partners develop an if-then plan for dealing with conflict and negativity, using strategies to downregulate their own negative emotions.
15963470|NCT03163082|Other|Interpretation Bias|"The Interpretation Bias intervention has partners look at morphed facial expressions and determine whether the face is happy or angry. Positive feedback is given for rating the faces as happy and negative feedback is given for rating the faces as angry."
15963471|NCT03163082|Other|Evaluative Conditioning|The Evaluative Conditioning intervention presents partners with pictures of ambiguous adult faces (conditioned stimuli) and pairs them with positive word descriptors (unconditioned stimuli; e.g., generous; loving).
15963472|NCT03163069|Combination Product|in-office bleaching with the conventional whitening dentifrice|Participants will receive in-office tooth bleaching with 40% hydrogen peroxide (Opalescence Boost PF 40%) for the maxillary anterior teeth (2 sessions, with a 1-week interval). During the tooth bleaching procedure and 3 weeks after the procedure, the participants will be instructed to brush their teeth twice with the conventional whitening dentifrice.
15963473|NCT03163069|Combination Product|in-office bleaching with the whitening dentifrice containing blue covarine|Participants will receive in-office tooth bleaching with 40% hydrogen peroxide (Opalescence Boost PF 40%) for the maxillary anterior teeth (2 sessions, with a 1-week interval). During the tooth bleaching procedure and 3 weeks after the procedure, the participants will be instructed to brush their teeth twice with the whitening dentifrice containing blue covarine.
15963474|NCT03163069|Combination Product|in-office bleaching with the regular dentifrice|Participants will receive in-office tooth bleaching with 40% hydrogen peroxide (Opalescence Boost PF 40%) for the maxillary anterior teeth (2 sessions, with a 1-week interval). During the tooth bleaching procedure and 3 weeks after the procedure, the participants will be instructed to brush their teeth twice with the regular dentifrice.
15963475|NCT03163056|Behavioral|Cognitive-behavioral treatment (CBT)|The CBT was implemented in group-based sessions of four patients. Sessions were carried out once a week over a 8-week period, with quite date occurring at fifth session. The main component was nicotine fading. From the first to the fourth week, patients were asked to gradually reduce their nicotine intake based on a weekly reduction of 30%. A maximum number of cigarettes per day and also specific cigarette brands with lower nicotine levels were recommended. Other components of the CBT program included information about tobacco, a behavioral contract, self monitoring and graphical representation of cigarette smoking, stimulus control, strategies for controlling nicotine withdrawal symptoms, physiological feedback, training in alternative behaviors, and relapse prevention strategies.
15963476|NCT03163056|Behavioral|CBT+Behavioral Activation (BA)|This intervention was provided as in the above CBT condition, that is, eight group-based sessions of four patients. Nevertheless, this treatment included a BA component for addressing both smoking cessation and depression management. The BA module included: treatment rationale, information on the relationship between smoking and depression, identification of life areas, values and activities, generation of meaningful and reinforcing activities, social support (i.e., behavioral contracts).
15963477|NCT03163056|Behavioral|CBT+BA+ Contingency Management (CM)|This intervention was provided in the same manner as the above mentioned treatment protocols but with the addition of a contingency management procedure reinforcing abstinence since fifth session and onwards. The number of sessions was the same as in the aforementioned treatment conditions and CO and cotinine samples were also collected. Participants providing negative specimens of both CO (≤4 ppm) and cotinine (≤80 ng/ml) earned points exchangeable for rewards (e.g., cinema tickets) on a schedule of escalating magnitude of reinforcement (from 10€ voucher value with maximum possible earnings of 175€ in vouchers).
15963478|NCT03163043|Dietary Supplement|Amino Acid Intake|Amino acid intakes will be varied at 0.2-2.67 g/kg/d
15963479|NCT03163030|Device|Vagus Nerve Stimulation (VNS)|Electrical Stimulation of the Vagus Nerve
15963480|NCT03163017|Device|2D Fluoroscopy|Patients with syndesmotic instability will undergo reduction of the syndesmosis followed by provisional fixation with a clamp or Kirshner wire. The reduction quality will be initially compared to the contralateral ankle mortise and talar-dome lateral radiographs using the technique of Summers et al i.e. 2D Fluoroscopy using device Ziehm Vision RFD 3D image-intensified fluoroscopic x-ray system.
15963481|NCT03163017|Device|3D Fluoroscopy|After the attending surgeon is satisfied with the reduction quality from 2D Fluoroscopy, 3D fluoroscopy using device Ziehm Vision RFD 3D image-intensified fluoroscopic x-ray system will be used to generate additional images to assess syndesmotic and fibular reductions.
15963482|NCT03163004|Behavioral|Implementation of standing desks|Three standing desks will be introduced to the classroom
15963483|NCT03162991|Other|Aerobic Exercise Intervention|Aerobic Exercise Intervention- 12-weeks, exercise 3 non-consecutive days/week for ~30-55 minutes per exercise session.
15963484|NCT03162978|Other|HIIT + POE|Subjects will participate in high-intensity interval training (HIIT) with an additional treatment component to increase positive outcome expectations (POE) of exercise.
15963485|NCT03162978|Other|HIIT only|Subjects will participate in high-intensity interval training (HIIT) only.
15963486|NCT03162965|Other|Oraquick HIV Self Test|This is an oral swab in home HIV test.
15963487|NCT03162965|Other|Clinic Based HIV Counseling and Testing (HCT)|Receiving Counseling and Testing for HIV at the clinic.
15963488|NCT03162926|Combination Product|VC-02 Combination Product (aka PEC-Direct)|PEC-01 cells loaded into a Delivery Device
15963489|NCT03162913|Dietary Supplement|Strawberry|12g freeze-dried strawberry (powder), twice daily with water, for 90 days
15963490|NCT03162913|Other|Placebo|12g red, strawberry-flavored powder, twice daily with water, for 90 days
15963491|NCT03162900|Drug|Glasdegib Therapeutic Exposure|Subjects Receive a single 150 mg dose of Glasdegib followed by ECG and PK assessments.
15963492|NCT03162900|Drug|Glasdegib Supra-therapeutic Exposure|Subjects receive a single 300 mg dose of glasdegib followed by ECG and PK assessments.
15963493|NCT03162900|Drug|Positive Control (Moxifloxacin)|Subjects will receive a single 400 mg dose of moxifloxacin followed by ECG and PK assessments.
15963494|NCT03162900|Other|Placebo Control|Subjects will receive placebo dose followed by ECG and PK assessments.
15963495|NCT03162887|Other|Educational Intervention|Receive a research team member-led breast cancer and mammogram educational module
15963496|NCT03162887|Other|Counseling|Undergo a web-based decision counseling session
15963497|NCT03162887|Other|Informational Intervention|"Receive a next steps document"
15963498|NCT03162874|Drug|Placebo oral capsule|BID
15963499|NCT03162874|Drug|PXT002331 - dose 1|Oral
15963500|NCT03162874|Drug|PXT002331 - dose 2|Oral
15963600|NCT03162081|Other|Comorbidity|Charlson comorbidity index and Cumulated illness rating scale (CIRS) based on electronic patient registry
15963753|NCT03160885|Drug|Placebo|Placebo contains the same excipients, in the same concentration only lacking tralokinumab
15963501|NCT03162861|Drug|sevoflurane inhalation for anesthesia|The elderly patients undergoing unilateral total hip arthroplasty will be randomized to assigned to the observation group. In the observation group, tracheal intubation will be conducted for general anesthesia after lumbar plexus-sciatic nerve block, accompanying sevoflurane inhalation for anesthesia maintenance.
15963502|NCT03162861|Drug|propofol for anesthesia|The elderly patients undergoing unilateral total hip arthroplasty will be randomized to assigned to the control group. In the control group, tracheal intubation will be conducted for general anesthesia, accompanying intravenous administration of propofol for anesthesia maintenance.
15963503|NCT03162848|Behavioral|SystemCHANGE|At initial home visit, the PI will work with the participant to identify important people for medication taking, routines, and cycles of routines. Possible solutions to incorporate medication taking into routines will be identified by the participant and PI and the participant will start implementing these solutions. Medication adherence will continuously be monitored using medication event monitoring systems. At one month, the participant will be sent a report on medication taking and a phone call will occur with the PI to discuss if solutions improved medication adherence or if other solutions need to be implemented. At month two, the intervention will end but participants are urged to continue to use solutions long term.
15963504|NCT03162835|Other|Pain Neuroscience Education|Children as well as their parents will receive a +/- 1h one-on-one educational session about the neurophysiology of pain, adjusted to the child's comprehension status. Parents will be present in the PNE session too. The PNE program for children contains two sections: (1) The healthy pain system and its function, divided in subsections each consisting of a specific neurophysiological pain concept (i.e. central nervous system anatomy, nociception and nociceptive pathways, up- and down-regulation of the nervous system) and (2) adaptations of the pain system following persistent pain. To ensure interaction between therapist and child, an interactive board game was developed and used throughout the full educational session.
15963505|NCT03162822|Behavioral|Behavioral Intervention|The behavioral intervention has the parents develop an if-then plan for dealing with conflict and negativity, using strategies to downregulate their own negative emotions.
15963506|NCT03162822|Other|Cognitive Intervention|The cognitive intervention has parents come up with reasons why their children do things they don't like, until they come up with benign attributions for those behaviors.
15963507|NCT03162822|Other|Interpretation Bias Intervention|"The Interpretation Bias intervention has parents look at morphed facial expressions and determine whether the face is happy or angry. Positive feedback is given for rating the faces as happy and negative feedback is given for rating the faces as angry."
15963508|NCT03162822|Other|Evaluative Conditioning|The Evaluative Conditioning intervention presents parents with pictures of ambiguous child faces (conditioned stimuli) and pairs them with positive word descriptors (unconditioned stimuli; e.g., sweet; cooperative).
15963509|NCT03162796|Drug|Guselkumab|Participants will receive 100mg of guselkumab as a sterile liquid for SC injection.
15963510|NCT03162796|Drug|Placebo|Participants will receive matching placebo as SC injection.
15963511|NCT03162783|Drug|ADX-102 Ophthalmic Solution (0.5%)|ADX-102 Ophthalmic Solution (0.5%) administered for approximately 4 weeks.
15963512|NCT03162783|Drug|ADX-102 Ophthalmic Solution (0.1%)|ADX-102 Ophthalmic Solution (0.1%) administered for approximately 4 weeks.
15963513|NCT03162783|Drug|ADX-102 Ophthalmic Lipid Solution (0.5%)|ADX-102 Ophthalmic Lipid Solution administered for approximately 4 weeks.
15963514|NCT03162770|Behavioral|Mindfulness meditation practice|This intervention is based on relaxation, well-being promotion, meditation practices and positive psychological principles. The program has been conducted during hemodialysis session. It will last for 12 weeks, with duration of 15 to 25 minutes, three times a week.
15963515|NCT03162757|Procedure|Central venous catheterization|Central venous catheterization via either internal jugular vein or subclavian vein up to a maximum of two attempts.
15963516|NCT03162744|Behavioral|Post-suicidal crisis interview|Protective factor exploration during post-suicidal crisis interview
15963517|NCT03162731|Biological|Nivolumab|Given IV
15963518|NCT03162731|Biological|Ipilimumab|Given IV
15963519|NCT03162731|Radiation|Simultaneous-Integrated Boost Intensity-Modulated Radiation Therapy|Undergo simultaneous integrated boost integrated modulated radiation therapy
15963520|NCT03162731|Radiation|Volume Modulated Arc Therapy|Undergo volumetric modulated arc therapy
15963521|NCT03162718|Behavioral|Exercise|single arm feasibility study of an unsupervised, pre-operative exercise prescription (uPEP) augmented by a wearable fitness device.
15963522|NCT03162679|Behavioral|Skills training of Affect-Regulation - A culture-sensitive approach: STARK|Emotion Regulation Group Therapy, 14 sessions, 1.5 hour sessions, group therapy, meeting weekly.
15963523|NCT03162666|Device|ALTERA|degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. with up to grade 1 spondylolisthesis
15963524|NCT03162653|Drug|Allopurinol|Allopurinol, powder for injection (PFI), administered in two doses. First dose (20 mg/kg in 2ml/kg sterile water for injection) given as soon as intravenous access is established and no later than 30min postnatally and second dose (10mg/kg in 1ml/kg sterile water for injection) 12 hours thereafter. The second dose will only be administered to in infants on therapeutic hypothermia. Infants who recover quickly and do not qualify for and hence do not undergo hypothermia will not receive a second dose. Administration will be by continuous infusion using a syringe pump over 10min through secure venous access.
15963525|NCT03162653|Drug|Mannitol|Placebo (Mannitol, PFI, 20mg/kg in the same volume and at the same time intervals as the intervention group - (2nd dose 10mg/kg only if infant undergoes therapeutic hypothermia)).
15963526|NCT03162627|Drug|Selumetinib|"Dose Escalation Phase Starting Dose: 50 mg by mouth twice a day on Days 1-28.
~Dose Expansion Phase Starting Dose: Maximum tolerated dose from Dose Escalation Phase."
15963527|NCT03162627|Drug|Olaparib|"Dose Escalation Phase Starting Dose: 150 mg by mouth twice a day on Days 1-28.
~Dose Expansion Phase Starting Dose: Maximum tolerated dose from Dose Escalation Phase."
15963528|NCT03162614|Biological|RTS,S/AS01E|Subjects will receive intramuscular injection of RTS,S/AS01E.
15963529|NCT03162614|Biological|RTS,S/AS01B|Subjects will receive intramuscular injection of RTS,S/AS01B.
15963602|NCT03162055|Drug|Glycopyrronium/Formoterol Fumarate|Metered dose inhaler (MDI), contains glycopyrronium/formoterol fumarate fixed-dose combination 7.2/4.8 μg per actuation
15963796|NCT03160521|Drug|Risperidone ISM 100 mg|Monthly IM injection in the gluteal or deltoid muscle.
15963530|NCT03162614|Procedure|Sporozoite-infected mosquitoes challenge.|"Mosquitoes infected approximately 2-3 weeks earlier that are likely to contain sporozoites in their salivary glands will be allowed to feed on the subjects. For each subject, five mosquitoes will be allowed to feed over five minutes, after which they will be dissected to confirm how many were infected, and the salivary glands scored. If required additional mosquitoes will be allowed to feed until a total of five infected mosquitoes with a minimum of 2+ salivary gland scores have fed.
~The challenge occurs approximately 90 days (three months) after the last vaccination.
~Subjects will be monitored during 28 days after having bitten by mosquitoes and when parasites are found in their blood, they will be treated with appropriate anti-malarial drugs."
15963531|NCT03162601|Procedure|Neurovascular percutaneous intervention|Patient will receive one extra CACT scan while they are receiving percutaneous neurovascular intervention.
15963532|NCT03162588|Drug|erythropoietin|Epokine®, CJ healthcare, South Korea is used preprocedurally to promote revascularization. Total 120,000 units of EPO is injected for three consecutive days, 40,000 units mixed in IV saline 100 ml over 1 hour. The multiple burrhole procedure is performed in area of hemodynamic insufficiency by D-SPECT. It is performed under local anesthesia.
15963533|NCT03162575|Behavioral|Mindfulness-Based Cognitive Therapy|Structured MBCT intervention based on the protocol of Williams, Teasdale, and Segal (2002)
15963534|NCT03162562|Biological|Oregovomab|Monoclonal antibody against CA 125
15963535|NCT03162562|Drug|Poly ICLC|Immune adjuvant
15963536|NCT03162536|Drug|Nemtabrutinib|Nemtabrutinib will be orally administered once per day under fasted conditions (1 hour prior to or 2 hours after a meal) and is available in tablets in strengths of 5 mg or 20 mg. For Expansion Food Effect Cohort I, nemtabrutinib will be orally administered once per day under fasted and non-fasted condition.
15963537|NCT03162523|Radiation|High-Dose Rate Brachytherapy|
15963538|NCT03162510|Drug|Oxaliplatin|Oxaliplatin 60 - 85 mg/m2 IVD 2hr at D1, every 14 days as a cycle till disease progression
15963539|NCT03162510|Drug|Albumin-Bound Paclitaxel /nab-Paclitaxel|150 mg/m2 IVD 30 min bi-weekly.
15963540|NCT03162510|Drug|S-1|Tegafur,oral S-1 35mg/m2 twice daily from D1 to D7, every 14 days as a cycle till disease progression.
15963541|NCT03162510|Drug|LV|LV 30mg twice daily from D1 to D7, every 14 days as a cycle till disease progression
15963542|NCT03162497|Drug|Azithromycin|Azithromycin 15mg/g eyedrops
15963543|NCT03162497|Drug|Doxycycline|Doxycycline 100 mg per os
15963544|NCT03162484|Behavioral|Experimental group|The program includes different activities: swimming, paddle tennis, football and aerobic exercises into the swimming-pool.
15963545|NCT03162471|Diagnostic Test|non-contact measurement of intraocular pressure|Non-contact measurement of corneal biomechanical properties and intraocular pressure with an Ocular Response Analyzer. Parameters measured: corneal hysteresis (CH), corneal resistance factor (CRF), Goldman-correlated IOP (IOPg), corneal compensated IOP (IOPcc) and waveform score (WS).
15963546|NCT03162458|Drug|Anaferon for children (liquid dosage form)|10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
15963547|NCT03162458|Drug|Placebo (liquid dosage form)|10 drops per dose. Day 1: 10 drops every 30 minutes for the first 2 hours, followed by three more doses regularly spaced during the rest of the day. Day 2 to 5: 10 drops three times daily.
15963548|NCT03162432|Drug|Vitamin D3|Oral Vitamin D3 therapy.
15963549|NCT03162419|Drug|Standard Medical Therapy|The patients in group A will be given standard medical therapy only as per requirement. Lactulose, bowel wash, albumin, terlipressin, antibiotics and anti-virals in hepatitis B reactivation will be continued and recorded.
15963550|NCT03162419|Biological|Plasma Exchange|High volume plasma exchange sessions till a maximum of ten sessions.
15963551|NCT03162419|Biological|GCSF|The GCSF in a dose of 5 ug/kg/day on day 1,2,3,4,5 followed by every 3rd day till day 28
15963552|NCT03162406|Dietary Supplement|Vitamin D3|Oral supplementation 25000 IU once per week for 6 months
15963553|NCT03162406|Dietary Supplement|Placebo|Oral supplementation once per week for 6 months
15963554|NCT03162393|Procedure|nerve transfer|
15963555|NCT03162380|Other|Date collection|Date collection
15963556|NCT03162367|Biological|Autologous epidermal cell suspension|First skin samples taken from normal skin by 4mm punch will be send to laboratory for preparation of epidermal cell suspension and this suspension transfer to one area of second degree burn
15963557|NCT03162367|Drug|Silver sulfadiazine ointment|the area with second degree burn dresses by silver sulfadiazine ointment and dressing change each 12 hour till 10 day
15963558|NCT03162354|Other|Application of a validated Clinical Decision Rule (CDR) as an AHT screening tool|"The Clinical Decision Rule (CDR) for AHT reads as follows:
~Every acutely head-injured infant or young child hospitalized for intensive care presenting with any one or more of these four variables should be considered high risk and thoroughly evaluated for abuse: (1) any clinically significant respiratory compromise at the scene of injury, during transport, in the Emergency Department, or prior to admission; (2) Any bruising involving the child's ear(s), neck, or torso; (3) Any subdural hemorrhage(s) or fluid collection(s) that are bilateral OR involve the interhemispheric space; (4) Any skull fracture(s) other than an isolated, nondiastatic, linear, parietal, skull fracture."
15963559|NCT03162341|Procedure|ultrasonography|The tophus volume will be assess using ultrasonography.
15963560|NCT03162341|Procedure|DECT|The tophus volume will be assess using dual-energy computed tomography (DECT).
15963561|NCT03162328|Device|PowerSleep Stim|Participants will wear the PowerSleep device with soft audio tones administered via the speakers during deep sleep throughout the night.
15963562|NCT03162328|Device|PowerSleep Sham|Participants wear the same PowerSleep device as with the active treatment, however no audio tones will be administered via the speakers.
15963563|NCT03162315|Procedure|Freeze all|
15963564|NCT03162302|Diagnostic Test|Magnetic Resonance Imaging (MRI)|Magnetic resonance imaging (MRI) is a non-invasive imaging technique that uses a magnetic field and radio waves to create detailed images of the organs and tissues within the body.
15963601|NCT03162068|Other|Osteodensitometry and pQCT|The peripheral Quantitative Computed analyses the bone architecture with distinction between cortical and trabecular compartment. We aim to determine the specificity of osteoporosis induced by glucocorticoids excess in comparison to post menopausal osteoporosis thanks to pQCT analysis.
15963565|NCT03162289|Other|Fasting|Patients follow a modified fasting regime of 60-72 h (36-48 h before and 24 h after CT) with a dietary energy supply of 350-400kcal per day with vegetable juices during the first four cycles of CT. During the rest of the CT cycles they will observe two days of caloric restriction (24 h before and after CT). Between CTs a mainly vegetarian diet will be performed and the patients are encouraged to follow a pattern of time restricted feeding with 14 h fasting over night at least for six days a week. The patients will receive an individual nutrition training by trained nutritionists.
15963566|NCT03162289|Other|Vegan|Patients follow a 60-72 h vegan diet with sugar restriction (36-48 h before and 24 h after CT) during the first four cycles of CT. During the rest of the CT cycles they will observe two days of vegan and sugar-restricted diet (24 h before and after CT). Between CTs a mainly vegetarian diet will be performed. The patients will receive an individual nutrition training by trained nutritionists.
15963567|NCT03162276|Behavioral|Inquiry Based Stress Reduction (IBSR) program|"The IBSR (Inquiry-based stress reduction) intervention, developed by Byron Katie, trains participants to reduce their perceived level of stress by self-inquiry of their thoughts and beliefs connected to stressful circumstances or symptoms. This meditative process, named The Work, enables the participants to identify and question the stressful thoughts that cause their suffering. The core of IBSR is simply four questions and a turnaround, which is a way of experiencing the opposite of what the participant believes. This process is simple, powerful and provides skills for self-inquiry and management of stressful thoughts that can be easily implemented in daily life"
15963568|NCT03162276|Behavioral|Control|At end of intervention, the control group will receive a brief intervention consisting of a home kit for practicing IBSR techniques.
15963569|NCT03162263|Device|EKso training|Patients affected by chronic stroke underwent gait training by using the Ekso device; they performed a total of 20 sessions (5 day/week for 4 weeks) of at leat 40min duration.
15963570|NCT03162250|Drug|DSTA4637S|DSTA4637S will be administered as an IV infusion at 3 dose levels.
15963571|NCT03162250|Drug|Placebo|Placebo matched to DSTA4637S IV infusion will be administered as specified.
15963572|NCT03162250|Drug|SOC|Anti-staphylococcal SOC antibiotics dosage and duration of therapy will be based on relevant health-authority approved indications and local and national treatment guidelines.
15963573|NCT03162237|Other|Porcine islets|"Porcine islets: 10000IEQ/Kg;
~Tacrolimus: 0.087mg/kg, Bid;
~mycophemo-latemofetil (MMF): 1g x 2/d;
~NULOJIX(belatacept): Day 1 (prior to transplantation), Day 5, Week 2, Week 4, Week 8, Week 12 10mg/kg"
15963574|NCT03162237|Other|Autologous Treg|Autologous Treg: 2x10^6/Kg
15963575|NCT03162224|Drug|MEDI0457|MEDI0457 Administration by IM injection followed by electroporation (EP) using CELLECTRA®5P device.
15963576|NCT03162224|Device|CELLECTRA®5P device (CELLECTRA 2000)|MEDI0457 Administration by IM injection followed by electroporation (EP) using CELLECTRA®5P device.
15963577|NCT03162224|Drug|Durvalumab|Durvalumab will be administered intravenously at a dose of 1500mg every 4 weeks.
15963578|NCT03162211|Other|Feedback Report|There are two types of feedback forms: 1. Patient feedback forms and 2. Clinician feedback forms. Feedback form content has been developed in consultation with a board of clinicians, service providers, and patients living with depression. Feedback forms will be comprehensive and condensed to a one page report including graphical presentations of symptom course and text. Clinician feedback forms will include content on depression severity over time and recommendations for individualized treatment. Patient feedback forms will also incorporate depression severity over time as well as summary information on achievement towards personalized treatment goals.
15963579|NCT03162198|Other|Cirrhosis with HCC|Cirrhosis with Hepatocellular Carcinoma
15963580|NCT03162198|Other|Cirrhosis without HCC|Cirrhosis without Hepatocellular Carcinoma
15963581|NCT03162185|Drug|Escitalopram|Experimental group participants (n = 30) will receive 20 mg of Escitalopram for 7 days.
15963582|NCT03162185|Drug|Placebo|Control group participants (n = 30) will receive a placebo for 7 days.
15963583|NCT03162159|Other|Collection of growth and bone maturation data|
15963584|NCT03162146|Other|Deaths in intensive care unit|Assessment of the influence of team familiarity among the members of medical and nursing staffs on risk of patient death
15963585|NCT03162133|Other|Baduanjin exercise|
15963586|NCT03162120|Drug|Ranolazine plus Metoprolol Combination|Ranolazine plus Metoprolol Combination in ATrial Fibrillation Recurrences FOllowing PhaRmacological or Electrical CardioverSion of AtRial Fibrillation
15963587|NCT03162120|Drug|FlecainidE pluS Metoprolol Combination|FlecainidE pluS Metoprolol Combination in ATrial Fibrillation Recurrences FOllowing PhaRmacological or Electrical CardioverSion of AtRial Fibrillation
15963588|NCT03162094|Drug|AVX012 Ophthalmic Solution Low dose|Ocular topical administration of AVX Ophthalmic Solution Low dose
15963589|NCT03162094|Drug|AVX012 Ophthalmic Solution High dose|Ocular topical administration of AVX Ophthalmic Solution High dose
15963590|NCT03162094|Drug|Placebo (vehicle)|Ocular topical administration of placebo (vehicle Ophthalmic Solution)
15963591|NCT03162081|Diagnostic Test|Substance misuse screening|Diagnostic and Statistical manual of mental disorders, version 4 (DSM-IV)/MINI-international Neuropsychiatric interview (MINI interview) for Diagnostics of dependence, additional questions for DSM-V classification, severity of dependence scale (SDS)
15963592|NCT03162081|Diagnostic Test|EQ-5D|Health related Quality of life
15963593|NCT03162081|Diagnostic Test|Impulsivity screening|Barratts impulsivity test v. 11, Behavioural inhibition/behavioural activation test
15963594|NCT03162081|Diagnostic Test|Cognitive screening|Minimental state examination (MMSE), Hospital anxiety and depression scale (HADS), Trail-making test, clock drawing test
15963595|NCT03162081|Diagnostic Test|Functional tests|Timed up and go (TUG), Single leg balancing test (SLB)
15963596|NCT03162081|Diagnostic Test|Cognistat|Assessment of cognitive domains
15963597|NCT03162081|Diagnostic Test|Neuropsychological profiling|Controlled Oral Word Association Test, Categorical fluency tests, Wechsler Adult Intelligence Scale, Color-Word Interference Test (CWIT) from the Delis-Kaplan Executive Function test
15963598|NCT03162081|Other|Clinical interview|Interview for sociodemographics, utilisation of health care, economic varables, The De Jong Gierveld Loneliness Scale
15963599|NCT03162081|Other|Medication use|Detailed screen of used medications, interactions, side effects in electronic patient registry
15963751|NCT03160898|Drug|Placebo|Oral tablet
15963603|NCT03162055|Drug|umeclidinium/vilanterol|Dry powder inhaler (DPI), Each metered dose contains umeclidinium/vilanterol 62.5/ 25μg fixed-dose combination per inhalation
15963604|NCT03162042|Procedure|Tumor removal|Surgery
15963605|NCT03162029|Other|CBCT imaging|CBCT imaging of participants, then take measurement by radiomorphometric indices
15963606|NCT03162016|Procedure|transplants|Transplant of palatine tissue and transplant of connective tissue Mucoderm
15963607|NCT03161990|Procedure|Transgluteal approach to the hip joint|Operative approach to the hip joint where the abductors are partly detached from the greater trochanter and the hip joint is approached through the anterior part of the capsule.
15963608|NCT03161990|Procedure|Posterior approach to the hip joint|Operative approach to the hip joint where the short external rotators are detached from the greater trochanter and the hip joint is approached through the posterior part of the capsule.
15963609|NCT03161977|Other|Mannitol|Mannitol was intravenous infused within 15-20 mins when drilling skull
15963610|NCT03161964|Drug|Propranolol 80 Mg Oral Capsule, Extended Release|Propranolol capsule over-encapsulated to match placebo for blinding
15963611|NCT03161964|Drug|Placebo oral capsule|Placebo capsule over-encapsulated to match propranolol for blinding
15963612|NCT03161938|Drug|Dexamethasone|intravenous
15963613|NCT03161912|Drug|Aflibercept (Eylea, BAY86-5321)|As per the treating physicians discretion.
15963614|NCT03161886|Device|Pan-enteric Capsule Endoscopy (PCE)|Second generation of colon capsule endoscopy (Medtronic)
15963615|NCT03161873|Device|Ava|Ava is a fertility monitoring bracelet that collects various physiological parameters
15963616|NCT03161860|Behavioral|Personalised citizen assistance for social participation(APIC)|The APIC involves a non-professional attendant who, after 2 to 5 days of training, provides a two to three-hour stimulation session each week over a six to eighteen-month period targeting significant social and leisure activities that are otherwise difficult for older adults to accomplish.
15963617|NCT03161847|Other|Non-interventional study|Non-interventional study
15963618|NCT03161834|Other|Observational|
15963619|NCT03161821|Other|Observational|
15963620|NCT03161782|Other|PNF stretching|For hold-relax stretching, each subject in PNF Stretching group will be comfortably positioned in a supine lying position, and patient will move the joint to the end of the passive or pain-free ROM. The therapist will ask for an isometric contraction of the restricting muscle or pattern (antagonists) with emphasis on rotation. The patients will be asked to perform submaximal isometric contractions of the target muscle for 10 seconds. After the contraction, the patients will be instructed to relax for 5 seconds. The joint will be repositioned actively to the new limit of range, and then therapist will passively control the new ROM. The procedure will be repeated 10 times with 10 seconds of rest between two successive trials. Patients will be treated 2 times per week for 6 weeks.
15963621|NCT03161782|Other|Static Stretching|For static stretching, each subject in Static Stretching group will be comfortably positioned in a supine lying position, and the stretching of target muscle will be maintained for 20 seconds followed by 10 seconds of rest. The procedure will be repeated 10 times with 10 seconds of rest between two successive trials. Patients will be treated 2 times per week for 6 weeks.
15963622|NCT03161782|Other|Exercise|Shoulder, elbow and wrist AROM exercises. Elbow flexion and extansion self-stretching exercises Elbow and wrist strengthening exercises Proprioception exercises for elbow. Grip strengthening exercises.
15963623|NCT03161782|Other|Cold Therapy|Cold therapy will be applied over the elbow for 15 minutes in the form of cold pack after stretching and exercise protocol.
15963624|NCT03161769|Procedure|Neurovascular treatment of intracranial aneurysms|Endovascular treatment of intracranial aneurysms using flow diverting stents
15963625|NCT03161769|Device|AneurysmFlow image processing software|Software to process and display images of intracranial aneurysm treatment using flow diverting stents.
15963626|NCT03161756|Drug|Denosumab|Denosumab is a fully human monoclonal immunoglobulin type 2 (IgG2) antibody that binds with high affinity and specificity to RANK ligand (RANKL) and neutralises the activity of human RANKL, similar to the action of endogenous osteoprotegerin (OPG). Denosumab binding prevents the activation of RANK and inhibits the formation, activation, and survival of osteoclasts. As a consequence, bone resorption and cancer-induced bone destruction are reduced.
15963627|NCT03161756|Drug|Nivolumab|Nivolumab is a human monoclonal antibody that targets the programmed death-1 (PD-1) cluster of differentiation 279 (CD279) cell surface membrane receptor. Nivolumab inhibits the interaction of PD-1 with its ligands, PD-L1 and PD-L2, resulting in enhanced T-cell proliferation and interferon-gamma (IFN-γ) release in vitro.
15963628|NCT03161756|Drug|Ipilimumab|Ipilimumab is a fully human monoclonal immunoglobulin specific for human cytotoxic T-lymphocyte antigen 4 (CTLA-4), which is expressed on a subset of activated T cells. Ipilimumab is a monoclonal antibody(mAb) that binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, cluster of differentiation antigen 80 / cluster of differentiation antigen 86 (CD80 / CD86). Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor-infiltrating T-effector cells.
15963629|NCT03161743|Procedure|venipuncture|blood draw for the purpose of determining the platelet concentration in PRP
15963630|NCT03161730|Other|McGrath videolaryngoscopy|Participants perform three intubation attempts using McGrath videolaryngoscope in the normal and cervical immobilized manikin by novice
15963631|NCT03161730|Other|Pentax videolaryngoscopy|Participants perform three intubation attempts using Pentax Airway Scope in the normal and cervical immobilized manikin by novice
15963632|NCT03161730|Other|Macintosh laryngoscopy|Participants perform three intubation attempts using Macintosh laryngoscope in the normal and cervical immobilized manikin by novice
15963633|NCT03161717|Device|Epidural electrical stimulation (EES)|Using loss of resistance technique and electrical stimulation
15963634|NCT03161717|Device|Loss of resistance (LOR)|Using loss of resistance technique only
15963635|NCT03161691|Procedure|Percutaneous treatment of ischemic stroke|An additional C-arm CT imaging scan will be done during neurovascular treatment to evaluate perfusion and collateral vessels in ischemic stroke patients.
15963636|NCT03161678|Drug|Clopidogrel|Clopidogrel (75 mg/d for 8 days) will be administered. Measures of pharmacodynamics will be assessed pre- and post-drug administration.
15963637|NCT03161678|Drug|Ticagrelor|Ticagrelor (90 mg twice daily for 8 days) will be administered. Measures of pharmacodynamics will be assessed pre- and post-drug administration.
15963638|NCT03161665|Other|BMT Roadmap|The BMT Roadmap is a health IT System that has been developed for use on the Apple iPad® to give the patient and caregivers easy access to test results, current treatment and contact information to hopefully increase active participation and engagement in transplant care.
15963639|NCT03161652|Drug|DME lactose pill|Patients with DME will take placebo orally 3 times a day (TID) for 8 weeks.The placebo is taken on top of standard therapy for diabetes and blood pressure control.
15963640|NCT03161652|Drug|DME levosulpiride|Patients with DME will take levosulpiride (75 mg/day) orally TID for 8 weeks. Levosulpiride is taken on top of standard therapy for diabetes and blood pressure control.
15963641|NCT03161652|Drug|DR lactose pill|Patients with non-proliferative DR will take a lactose pill (placebo) orally TID for 8 weeks. The placebo is taken on top of standard therapy for diabetes and blood pressure control.
15963642|NCT03161652|Drug|DR levosulpiride|Patients with non-proliferative DR will take levosulpiride (75 mg/day) orally TIDfor 8 weeks. Levosulpiride is taken on top of standard therapy for diabetes and blood pressure control.
15963643|NCT03161652|Drug|DR vitrectomy lactose pill|Patients with proliferative DR (undergoing medically prescribed vitrectomy 7 days after starting the study medication) will have to take a lactose pill (placebo) orally TID for one week. The last placebo pill will be taken on the morning of the day vitrectomy is performed. The placebo is taken on top of standard therapy for diabetes and blood pressure control.
15963644|NCT03161652|Drug|DR vitrectomy levosulpiride|Patients with proliferative DR (undergoing medically prescribed vitrectomy 7 days after starting the study medication) will take levosulpiride (75 mg/day) orally TID for one week. The last pill will be taken on the morning of the day vitrectomy is performed. Levosulpiride is taken on top of standard therapy for diabetes and blood pressure control.
15963645|NCT03161652|Drug|DME plus ranibizumab lactose pill|Patients with DME with conventional intravitreal antiangiogenic therapy with ranibizumab (0.5 mg every 4 weeks for 12 weeks) will take a lactose pill (placebo) orally TID for 24 weeks. The placebo is taken on top of standard therapy for diabetes and blood pressure control.
15963646|NCT03161652|Drug|DME plus ranibizumab levosulpiride|Patients with DME with receive intravitreal antiangiogenic therapy with ranibizumab (0.5 mg every 4 weeks for 12 weeks) will take a levosulpiride (75 mg/day) orally TID for 24 weeks. The study medication is taken on top of standard therapy for diabetes and blood pressure control.
15963647|NCT03161639|Other|Pulpectomies|Primary teeth pulpectomy is an important treatment option for necrotic teeth. The correct working length will determine a better chemical and mechanical disinfection of the root canals, without demanding the surrounding periapical tissues and dental germs. In addition, it decreases the chance of a sub or over-filling, which also may interfere with the achievement of the success.
15963648|NCT03161626|Drug|Coagadex|Plasma-driven blood coagulation factor X concentration
15963649|NCT03161613|Other|Non-Interventional|Non-Interventional
15963650|NCT03161600|Behavioral|Carevive CPS|This intervention will focus on the use of the Carevive CPS at a surgical visit, enabling providers to deliver evidence-based and personalized treatment care plans to their breast cancer patients. The Carevive CPS collects electronic patient reported outcomes (ePROS) and clinical data, reported and generated by clinical staff and/or extracted from the electronic medical record (EMR), and uses these to auto-generate the personalized care plans. Care plan content is drive by practice guidelines and other peer-reviewed evidence, and includes patient education, resources, and referrals developed by cancer clinicians and researchers.
15963651|NCT03161574|Drug|FOLFOXIRI|irinotecan* 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5FU 2800 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle
15963652|NCT03161561|Other|capacity of primary phagocytes|measurement of capacity of primary phagocytes (neutrophils, monocytes and macrophages) isolated from COPD patients' blood or alveolar macrophages isolated from patients' lungs to carry out key host defence functions and compare these to similar cells isolated from age and sex-matched non-smokers or smokers without COPD as controls.
15963653|NCT03161548|Drug|Induction chemotherapy|"All eligible subjects will receive ICT with DCU regimen every 21 days as follows:
~Docetaxel 36 mg/m2 intravenous infusion over 1 hr, followed by Cisplatin 30 mg/m2 intravenous infusion over 1 hr, on day 1 and day 8, Oral tegafur/uracil 300 mg/m2/day plus leucovorin 90 mg/day on days 1 - 14"
15963654|NCT03161548|Procedure|Tongue conservation surgery|Surgical excision of residual oral tongue tumor will be performed in 3-4 weeks after the start of the last cycle of ICT. Neck dissection will also be done as indicated.
15963655|NCT03161548|Radiation|postoperative CCRT|"Post-op CCRT will be started 4-6 weeks after surgery, with regimen as follows:
~Radiotherapy in 2 Gy once-daily fraction size, Monday to Friday, with dose up to 60 Gy (total of 30 fractions); Cisplatin 25 mg/m2 intravenously for 4 hours every week a cycle to total 6 cycles; Tegafur/uracil (UFUR) 200 mg po bid for whole course of radiotherapy"
15963656|NCT03161535|Other|exercise and dietary education|"A 12-week regimen of home-based walking exercises, comprising walking at a moderate intensity for 40 min, three times a week, was administered along with weekly exercise counseling. After collecting pretrial measurements, we explained the participants how to perform the exercises, according to an instruction manual for the exercise regimen. The detailed instructions, provided at the hospital clinics, included the determination of activity intensity, demonstration of pulse measurement, criteria for scores of 6-20 on the Borg's rating of perceived exertion (RPE), prevention of exercise-related injuries, and conditions necessitating termination of an exercise session. Participants were instructed that the exercises would be effective only if they reached 60%-80% of the target heart rate, as determined by the Karvonen method, and 13-15 on the RPE.
~Diet-teaching program (using dietary education booklet)."
15963657|NCT03161535|Other|weekly telephone consultations concerning exercise and diet.|For each participant, we discussed exercise regimen-related issues and diet weekly through the telephone. For instance, we discussed whether participants' exercise fulfilled the prescribed intensity, duration, or frequency and whether the participants experienced any adverse effects.
15963658|NCT03161522|Drug|Capecitabine|Patients will receive 5-fluorouracil (5-FU) and capecitabine as maintenance chemotherapy.
15963659|NCT03161522|Drug|Chemotherapy|Receive induction chemotherapy
15963660|NCT03161522|Procedure|Conventional Surgery|Undergo surgery
15963661|NCT03161522|Drug|Fluorouracil|Patients will receive 5-fluorouracil (5-FU) and capecitabine as maintenance chemotherapy.
15963662|NCT03161522|Radiation|Radiation Therapy|Undergo RT
15963663|NCT03161509|Drug|Paracetamol|single dose of 1 gr paracetamol
15963664|NCT03161509|Drug|Antiepileptic (either carbamazepine, lamotrigine, phenytoin or valproic acid)|Single dose of antiepileptic drug (either carbamazepine, lamotrigine, phenytoin or valproic acid) for which the participant is taking chronically in stable dose
15963665|NCT03161496|Genetic|detection of genotype|detection of genotype by next generation sequencing
15963666|NCT03161483|Drug|CC-220|CC-220
15963667|NCT03161483|Other|Placebo|Placebo QD PO
15963668|NCT03161470|Other|Standard Repositioning|It is standard clinical practice for patients with BPPV to undergo treatment by moving the patient through specific head/body positions which moves the displaced otoconial debris out of the involved area of the inner ear.
15963669|NCT03161470|Other|Mechanical Chair Repositioning|It is standard clinical practice for patients with BPPV to undergo treatment by moving the patient through specific head/body positions which moves the displaced otoconial debris out of the involved area of the inner ear.
15963670|NCT03161470|Other|Sham Treatment|Participants will be placed into the mechanical chair and moved into various positions that do not treat BPPV.
15963671|NCT03161457|Biological|JHL1101|1000 mg containing 10 mg/mL rituximab to be diluted to a concentration of 1 to 4 mg/mL in 0.9% normal saline or 5% D-glucose for administration
15963672|NCT03161457|Biological|MabThera|1000 mg containing 10 mg/mL rituximab to be diluted to a concentration of 1 to 4 mg/mL in 0.9% normal saline or 5% D-glucose for administration
15963673|NCT03161444|Other|Biological sample collection|A blood sample collection for the study will be taken to each participant Each subject enrolled must have previously participated to the study CHIKVIH.
15963674|NCT03161431|Drug|SX-682|SX-682 is an oral small molecule selective inhibitor of C-X-C Motif Chemokine Receptor 1 (CXCR1) and C-X-C Motif Chemokine Receptor 2 (CXCR2)
15963675|NCT03161431|Biological|Pembrolizumab|Pembrolizumab is a humanized antibody that targets the programmed cell death 1 receptor (PD-1).
15963676|NCT03161418|Drug|KSP-910638G, 0.4 mg|The investigational agent to be used in this study is KSP heptapeptide, which is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached via a 5 amino acid linker to a near-infrared fluorophore, IRDye800CW. (0.4 mg dose)
15963677|NCT03161418|Drug|KSP-910638G, 1.2 mg|The investigational agent to be used in this study is KSP heptapeptide, which is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached via a 5 amino acid linker to a near-infrared fluorophore, IRDye800CW. (1.2 mg dose)
15963678|NCT03161405|Drug|TAK-906 Maleate|TAK-906 capsule
15963679|NCT03161405|Drug|Itraconazole|Itraconazole solution
15963680|NCT03161392|Diagnostic Test|Follow-up|"Group No ductal lesion will be submitted to follow-up with periodic breast ultrasonography/mammography every 6 months for 2 years."
15963681|NCT03161392|Diagnostic Test|Ultrasound-guided percutaneous biopsy|"Group Ductal lesion will be submitted to ultrasound-guided percutaneous biopsy and the specimen will be histologically analysed."
15963682|NCT03161379|Drug|Cyclophosphamide|Cyclophosphamide 200 mg/m2 will be administered one day prior to vaccination (day 0). First dose will be given within 4 to 6 weeks after chemotherapy. 3 weeks after the first dose of immunotherapy the second dose will be given.
15963683|NCT03161379|Drug|Nivolumab|Nivolumab (240 mg) will be administered one day prior to vaccination. First dose will be given within 4 to 6 weeks after chemotherapy. 3 weeks after the first dose of immunotherapy the second dose will be given.
15963684|NCT03161379|Drug|GVAX Pancreas Vaccine|Vaccine will be administered one day after cyclophosphamide and nivolumab. 3 weeks after the first dose of immunotherapy the second dose will be given.
15963685|NCT03161379|Radiation|Stereotactic Body Radiation (SBRT)|SBRT (6.6 Gy over 5 days) will be started during the second dose of immunotherapy (3 weeks after the first dose of immunotherapy).
15963686|NCT03161366|Biological|rVSVΔG-ZEBOV-GP|Ring vaccination with vaccination of contacts and contacts of contacts after laboratory confirmation of one Ebola Zaire case
15963687|NCT03161353|Drug|Perjeta|All patients will receive Perjeta® as an IV infusion on Day 1 of the first treatment cycle as a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent 3-week cycle. Perjeta® IV should be administered 60 minutes after the end of Herceptin® SC (subcutaneous) administration. An observation period of 30-60 minutes is recommended after each Perjeta® infusion.
15963688|NCT03161353|Drug|Herceptin|All patients will receive a fixed dose of 600 mg, irrespective of the patient's weight, will be administered throughout the treatment phase. All doses of Herceptin® SC will be administered as an SC injection into the thigh by a trained health care professional over a period of 2-5 minutes. No loading dose is required with Herceptin® SC.
15963689|NCT03161353|Drug|Docetaxel|Docetaxel will be administered in line with the respective product information and/or recognized clinical practice guidelines. It will be administered after Herceptin® SC, Perjeta® IV, and carboplatin
15963690|NCT03161353|Drug|Carboplatin|Carboplatin will be administered in line with the respective product information and/or recognized clinical practice guidelines. It will be administered after Herceptin® SC and Perjeta® IV.
15963691|NCT03161353|Drug|Letrozole|Postmenopausal women will receive letrozole 2.5 mg tablet orally once daily beginning on Day 1 and continuing through Day 21 of a 21-day cycle as neoadjuvant therapy.
15963692|NCT03161353|Drug|Tamoxifen|"Premenopausal women will receive tamoxifen 20 mg tablet orally once daily beginning on Day 1 and continuing through Day 21 of a 21-day cycle as neoadjuvant therapy.
~Male patients will receive tamoxifen 20 mg tablet orally once daily beginning on Day 1 and continuing through Day 21 of a 21-day cycle as neoadjuvant therapy."
15963693|NCT03161340|Drug|Rapamycin|Patients will take Rapamycin 2 days before IVF until 15 days after IVF
15963694|NCT03161327|Device|ABI using QuantaFlo™|"Perform Digital ABI:
~Will be performed by the nurse/medical assistant with training to perform this test
~The patient will be placed in the supine position, with the arms and legs at the same level as the heart, for a minimum of 5 minutes before measurement.
~The optical sensor (similar to a pulse oximeter) will be placed sequentially in the fingers of the hands and feet: Right and left hand fingers and then right and left feet toes.
~Usually each digit takes about 15 seconds to obtain a waveform
~At the end of 60 seconds, an automated digital ABI will be generated.
~Clinical course: If based on Screening questionnaire and digital ABI, I. Patient is diagnosed with PAD- the referring physician and patient will receive a phone call about the same. He/ she will then be advised any further testing/ referral to IR clinic.
~II. There is no evidence of PAD- no further action will be taken. The patient will be informed of the same."
15963695|NCT03161314|Procedure|Conservative physical therapy treatment with strengthening exercise program, and Conservative physical therapy treatment with stretching exercise program|(Sub-project 3) conservative physical therapy treatment with self-strengthening and with self-stretching home based exercises
15963696|NCT03161288|Drug|KY1005|A human anti-OX40 ligand monoclonal antibody
15963697|NCT03161288|Drug|Placebo|Matched placebo
15963698|NCT03161262|Behavioral|SMS-based reminders|The SMS-based reminders consist of sending messages to participants assigned to this study arm reminding them to take their medication and prompting participants to complete surveys. Medication reminders are sent as per the participant's prescribed frequency and weekly surveys allow participants to report their pain level as well as send an image of their surgical site. Beyond pre-determined reminders and surveys sent to patients, the Memora Health platform is interactive and allows patients to text in questions they may have regarding their medications, care, or condition. Participants will receive the messages for 3 months.
15963699|NCT03161249|Behavioral|Experimental group|The experimental group receiving mobile treatment: treatment as usual plus a psychotherapy intervention by the telephone app (a total of 5 modules of psychotherapy: psychoeducation plus mindfulness plus alerts plus social wall plus problems solving)
15963700|NCT03161249|Other|Control group|Group that does not receive any treatment added to its usual treatment
15963701|NCT03161236|Other|home exercise program|Subjects in the exercise group will be instructed to follow the intervention protocol for eight weeks. The intervention consists of five exercises: standing on one foot, walking heel to toe, heel walking, side kicks, and wall squats. Each exercise will be repeated three times per week for eight weeks.
15963702|NCT03161236|Other|non exercise program|continue usual lifestyle
15963703|NCT03161223|Drug|Durvalumab|"Durvalumab is an investigational human monoclonal antibody that works to inhibit (block) a protein called programmed cell death-1 ligand 1 (PD-L1). Durvalumab has not been approved by the FDA for the treatment of PTCL but has been given to patients other types of cancers. Given intravenously (through the vein).
~Starting dose: 1500 mg"
15963704|NCT03161223|Drug|Pralatrexate|"Pralatrexate is an antimetabolite drug. Pralatrexate alone is FDA-approved for the treatment of PTCL. Given intravenously (through the vein).
~Starting dose: 25 mg/m2"
15963705|NCT03161223|Drug|Romidepsin|"Romidepsin is another type of chemotherapy known as histone deacetylase (HDAC) inhibitors. Romidepsin has not been approved for use in lymphoma other than Cutaneous T cell lymphoma (CTCL) by the FDA. Given intravenously (through the vein).
~Starting dose: 12 mg/m2"
15963706|NCT03161223|Drug|5-Azacitidine|"Oral 5-azacitidine is used for the treatment of myelodysplastic syndrome and acute myeloid leukemia. Azacitidine prevents the body from making DNA and RNA that cells need to grow. This stops the growth of cancer cells and causes them to die. Given by mouth (orally).
~Starting dose: 300 mg daily"
15963707|NCT03161210|Other|Dextrose Prolotherapy|Dextrose is a solution, mixture of dextrose and water.
15963708|NCT03161210|Other|Local Anaesthesia|A local anaesthetic is a medication that causes reversible absence of pain sensation
15963709|NCT03161210|Other|Saline|Saline is a control group
15963710|NCT03161197|Behavioral|Mindfulness-Based Stress Reduction|The intervention consists of mindfulness-based stress reduction. Key components of what the intervention consists relate to stress management, breathing, and meditation, as well as, techniques aimed at improving relations with others, sense of mastery and purpose in life. Additionally, the intervention subjects, during every point of contact, will be asked how often they utilized the strategies they were taught. This information will be helpful in understanding each subject's individual level of mastery and proficiency in Mindfulness-Based Stress Reduction (MBSR).
15963711|NCT03161184|Behavioral|SUSTAIN Smartphone training of CHW (SP+)|"Intervention (Smart phone assisted): During prenatal household visits, the smart phone based application guides CHW through electronic decision tree protocols, directing them to specific health/nutrition counseling topics and messages based on each woman's gestational age, and her answers to a specific series of diagnostic questions. Based on the client's gestational age, the tool directs CHW to lessons in an accompanying photo book, and reminds them to counsel on the importance of accessing timed and targeted maternal health services at health facilities. The application also assists CHW to identify danger signs during pregnancy, flags clients who require immediate referral to health facilities, and reminds CHW to follow-up with clients who were previously referred to clinics."
15963712|NCT03161184|Behavioral|SUSTAIN Paperbased training of CHW (SOC)|SUSTAIN Paperbased training of CHW (SOC): During prenatal household visits, the CHW asks a specific series of diagnostic questions based on the client's gestational age, offers counsel on the importance of accessing appropriate maternal health services at health facilities and uses lessons in an accompanying photo book to deliver messages on a variety of maternal and newborn health and nutrition topics. CHW are trained to identify danger signs during pregnancy, flag clients who require immediate referral to health facilities, and follow-up with clients who were previously referred to clinics.
15963713|NCT03161171|Other|This is an observational study|This is an observational study
15963714|NCT03161158|Device|CHIARA-System|Treatment with veno-venous ultrafiltration (CHIARA-System) complementary to low-dose diuretic therapy according to treatment algorithm. 1-7 Ultrafiltration sessions (6-10h/session, number of sessions depending on clinical assessment) for at least 1-2 consecutive days and a maximum of 7 days.
15963715|NCT03161158|Other|Usual care IV diuretics|Guideline-directed therapy including IV loop diuretics (according to treatment algorithm)
15963716|NCT03161132|Drug|Olaparib|Combination of continous olaparib 300mg for oral administration plus Pegylated Liposomal Doxorubicin (PLD), followed by maintenance treatment further described.
15963717|NCT03161132|Drug|Pegylated Liposomal Doxorubicin|PLD 40mg/m2 every 28 days intravenous
15963718|NCT03161119|Device|Ultrasound guided embryotransfer with Cook K-Jets-551910-S|"On the day of ET, patient will be asked to come with full bladder. ET will be done with patient in lithotomy position. No anesthesia will be used for the procedure. Under sterile condition, vaginal parts will be cleaned with saline and draped and speculum inserted to expose cervix. Cervical mucus and cervix will be cleaned with sterile media.
~The Et procedure itself is standardized as far as possible amongst the participating physicians to eliminate bias."
15963752|NCT03160885|Drug|Tralokinumab|Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous (SC) administration
15963719|NCT03161119|Device|Ultrasound guided embryotransfer with Cook k-soft-5000 (or K-J-SP-681710 and K-J-SPPE-681710)|"On the day of ET, patient will be asked to come with full bladder. ET will be done with patient in lithotomy position. No anesthesia will be used for the procedure. Under sterile condition, vaginal parts will be cleaned with saline and draped and speculum inserted to expose cervix. Cervical mucus and cervix will be cleaned with sterile media.
~The Et procedure itself is standardized as far as possible amongst the participating physicians to eliminate bias."
15963720|NCT03161106|Dietary Supplement|Nutrition|Nutrional group-30 kcal/kg with 1.5 grm protein with protein supplements
15963721|NCT03161106|Drug|Lactulose|Lactulose plus diet consumed by patient
15963722|NCT03161106|Dietary Supplement|Diet|Protein Powder 15 to 20 gm/meal/day
15963723|NCT03161093|Drug|Fasinumab|Solution for injection in pre-filled syringe
15963724|NCT03161093|Drug|Naproxen|Pharmaceutical form: Capsule
15963725|NCT03161093|Drug|Fasinumab-matching placebo|Solution for injection in pre-filled syringe
15963726|NCT03161093|Drug|Naproxen-matching placebo|Capsule
15963727|NCT03161080|Device|Neovis Total Multi® Eye Drops|Eye Drops containing Sodium hyaluronate (0.18%), lipoic acid, hydroxypropyl methylcellulose
15963728|NCT03161080|Device|Vismed Multi® Eye Drops|Eye Drops containing Sodium hyaluronate (0.18%), potassium chloride, disodium phosphate
15963729|NCT03161080|Device|Hydrabak® Eye Drops|Eye Drops containing sodium chloride (0,9%), sodium dihydrogen phosphate dehydrate
15963730|NCT03161067|Device|BiCNS|Surgical implantation
15963731|NCT03161054|Drug|Prednisone|"Induction Phase: Prednisone (Deltacortene) 25 mg /day will be orally administered from day 1 to day 28 only in cycle 1 From cycle 2 to 6 reduce to three times a week (after breakfast).
~Maintenance Phase: Prednisone 25 mg/day will be orally administered twice a week continuously (after breakfast).
~Post Maintenance Phase: Prednisone 25 mg/day will be orally administered twice a week continuously (after breakfast)."
15963732|NCT03161054|Drug|Vinorelbine|"Induction Phase: Vinorelbine 30 mg/day will be orally administered three times a week, 3 weeks on and 1 week off (after breakfast).
~Maintenance Phase: Vinorelbine 30 mg/day will be orally administered three times a week, 3 weeks on and 1 week off (after breakfast).
~Post Maintenance Phase: vinorelbine 30 mg/day will be orally administered three times a week, 3 weeks on and 1 week off (after breakfast)."
15963733|NCT03161054|Drug|Etoposide|Induction Phase Etoposide: 50 mg/day will be orally administered from day 1 to day 14 (before lunch); Superfrail patients only from cycle 3, 50 mg/day, from day 1 to day 7
15963734|NCT03161054|Drug|Cyclophosphamide|"Induction Phase: Cyclophosphamide 50 mg/day will be orally administered from day 1 to day 21 (after dinner).
~Maintenance Phase: 50 mg/day will be orally administered from day 1 to day 14 (after dinner)."
15963735|NCT03161054|Drug|Rituximab|Induction Phase: Rituximab: 375 mg/m2 will be administered by IV infusion up to four infusions on days 8, 15, 22, 29, only in patients suitable for infusion treatment and relapsed after >6 months from last R-chemotherapy. Refractory patients who received at least 5 doses of Rituximab will not repeat it during the metronomic therapy.
15963736|NCT03161041|Procedure|Cytoreductive surgery combined with HIPEC|Procedure/Surgery: Cytoreductive surgery combined with HIPEC (Oxaliplatin 360 mg/m2).
15963737|NCT03161041|Drug|bevacizumab and HIPEC (Oxaliplatin 360 mg/m2).|bevacizumab and HIPEC (Oxaliplatin 360 mg/m2).
15963738|NCT03161028|Drug|Lipoic acid|1200 mg taken by mouth daily for two years starting on day one of the study and ending on the last day of study participation.
15963739|NCT03161028|Drug|Placebo|The placebo comparator will be taken by mouth daily for two years starting on day one of the study and ending on the last day of study participation
15963740|NCT03161015|Drug|GBT440|Oral
15963741|NCT03161002|Genetic|detection of genotype|detection of genotype by next generation sequencing
15963742|NCT03160989|Other|physical exercises|The intervention will consist of a single session and after ten weeks of combined physical exercises (aerobic and resisted). All volunteers will participate in the same procedure.
15963743|NCT03160976|Other|Cryolipolysis|First, the demarcation of the lower abdomen area at the same landmarks of the ultrasonography will be done. Secondly, the patient will be positioned on the stretcher in the supine position with a 45 ° elevation of the trunk. In this position, to protect the region to be treated, a glycerine antifreeze membrane will be placed. The treatment parameters will be: temperature of -10 ° C, treatment time of 50 minutes (first 3 minutes of heating at 42°C) and moderate vacuum pressure (60 - 40 Kpas). The applicator will be chosen according to the size of the area of each subject and positioned in the target region. At the end the skinfold will be released automatically, the antifreeze membrane removed and a manual massage will be carried out for five minutes to stimulate local blood reperfusion.
15963744|NCT03160963|Other|Power Testing|Chair stand, vertical jump, computerized squat
15963745|NCT03160950|Device|LuxaCrown|"Teeth that would be requiring RCT, would be initially treated by a endodontist using the standardized principles of rotary endodontics.
~Restoration using the LuxaCrown as a direct composite crown: In short, the impression material will be loaded with the LuxaCrown material (DMG, Germany). Approx. 0:40 minutes after the start of mixing, the filled impression will be placed in the patient's mouth and will stay there for approx. 1:45 - 2:20 minutes, that is, till the material is partially set. The impression will then be taken out and the material will be allowed to set outside patient's mouth up to approximately 5 minutes after the start of mixing. The Crown will then be finished using a fine buff and pumice, followed by application of Glaze and Bond (DMG, Germany). The preparation will then be cleaned and slightly roughened with a bur or sand blaster at the adhesion sites. The crown fabricated will then be cemented using PermaCem 2.0 luting cement (DMG, Germany)."
15963746|NCT03160937|Other|Manual therapy|The subjects repeated this motion for 1 min, rested for 30 s, and then repeated it again for 5 sets.
15963747|NCT03160924|Other|Enhanced Recovery After Surgery (ERAS)|"same as above as described in the arms."
15963748|NCT03160911|Device|Over-the-scope clip (OTSC)|The device provides a robust and strong tissue apposition. The system was developed to close perforations and treat bleeding in the gastrointestinal tract. In chronic ulcers, an anchor device can be used to pull the ulcer base toward the aspiration cap to facilitate accurate clip application. Endoscopic haemostasis would be achieved with the use of this device and/or injection of adrenaline
15963749|NCT03160911|Device|Conventional Endoscopic Haemostasis|This includes the use of heater probe, endoscopic clipping and injection of adrenaline for endoscopic haemostasis
15963750|NCT03160898|Drug|Reldesemtiv|Oral tablet
15963754|NCT03160872|Diagnostic Test|Anti Mullerian Hormone Measurement|Anti Mullerian Hormone was measured in all patients within two months before the first insemination cycle
15963755|NCT03160859|Other|Control|Unsedated colonoscopy with water exchange (WE) where the residual air in the colon will be removed and water will be infused to guide insertion through an airless lumen. Infused water is removed predominantly during insertion.
15963756|NCT03160859|Device|Study method|Unsedated colonoscopy with water exchange (WE + cap) and the addition of a cap fitted to the colonoscope.
15963757|NCT03160846|Drug|Inotrope|Home intravenous infusion of Dobutamine, Dopamine, or Milrinone
15963758|NCT03160833|Drug|HMPL-453|oral administrative
15963759|NCT03160820|Biological|Measles, mumps and rubella Combined Vaccine, Live|Subjects will be inoculated one dose of MMR vaccine and collected blood samples before and after vaccination.
15963760|NCT03160807|Drug|Levofloxacin|Levolet 500 mg OD for 5 days
15963761|NCT03160807|Drug|Levofloxacin|Levolet 500 OD for 10 days
15963762|NCT03160794|Diagnostic Test|[18F]DCFPyL PET/MRI scan|PET/MRI imaging using the radiotracer, [18F]DCFPyL
15963763|NCT03160794|Radiation|Stereotactic Ablative Radiotherapy|SABR as treatment for lesions identified using [18F]DCFPyL PET/MRI
15963764|NCT03160781|Biological|Platelet Rich Plasma|Combination of Intraosseous and Intraarticular Infiltration of Platelet Rich Plasma
15963765|NCT03160742|Device|Mespere VENUS 200CVP system|Non-invasive sensor placed on the neck
15963766|NCT03160729|Drug|Dexamethasone|pre-operative, single-shot injection
15963767|NCT03160716|Device|Restylane Lyft with Lidocaine|a sterile gel of hyaluronic acid (HA)
15963768|NCT03160703|Other|Stannous fluoride (SnF2, 0.454%), Sodium tripolyphosphate (STP, 5%), 2.0% abrasive silica|Participants will apply a full brush head of their dentifrice containing 0.454% SnF2 / 5% STP; 2.0% abrasive silica (RDA~58) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate.
15963769|NCT03160703|Other|Stannous fluoride (SnF2, 0.454%), Sodium tripolyphosphate (STP, 5%), abrasive silica (3.5%)|Participants will apply a full brush head of their dentifrice containing 0.454% SnF2 / 5% STP; 3.5% abrasive silica (RDA~77) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate.
15963770|NCT03160703|Other|Sodium Monofluorophosphate (1000 ppm fluoride ), RDA~80|Participants will apply a full brush head of their dentifrice containing 1000 ppm fluoride as SMFP with moderate abrasivity (RDA~80) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate.
15963771|NCT03160703|Other|Stannous fluoride (SnF2, 0.454%), RDA~120|Participants will apply a full brush head of their dentifrice containing 0.454% SnF2 with higher abrasivity (RDA~120) and will brush twice daily (morning and evening) for one timed minute (in their usual manner) and expectorate.
15963772|NCT03160690|Procedure|Non penetrating deep sclerectomy|Non penetrating deep sclerectomy for open angle glaucoma
15963773|NCT03160677|Other|Systolic blood pressure target < 130 mm Hg|Adaptation of antihypertensive treatments to reach the Systolic blood pressure target < 130 mm Hg
15963774|NCT03160677|Other|Systolic blood pressure target < 185 mm Hg|Adaptation of antihypertensive treatments to reach the Systolic blood pressure target < 185 mm Hg
15963775|NCT03160664|Device|Magpro X100 + Option|In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of MST in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks.
15963776|NCT03160664|Device|ThymatronSystem Ⅳ Electroconvulsive System|In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of modified ECT in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks
15963777|NCT03160664|Other|treatment as usual (TAU)|Participants will engage in their inpatient treatment program as-usual.
15963778|NCT03160651|Drug|Methylprednisolone or placebo|Patients will receive 28 days of methylprednisolone 32 mg/day
15963779|NCT03160638|Drug|Azithromycin 250 mg|Patients will be treated with azithromycin 250 mg once daily for 28 days. An azithromycin loading dose of 500 mg (two tablets of 250 mg) will be administered on day 1
15963780|NCT03160625|Device|Rate Adaptive Pacing|Rate Adaptive Pacing varies the pacing rate in response to the patient's physical motion as detected by an activity sensor.
15963781|NCT03160612|Behavioral|Transfer Training|Transfer training interventions will take approximately 1 hour to complete and consist of an interactive web based module that participants interact with which includes text, pictures, videos and time to practice new skills. Additionally, participants will receive an educational handout summarizing the online module.
15963782|NCT03160599|Other|ketogenic diet|The treatment is mainly restricted calorie ketogenic diet. KD will consist of 4:1-1:1[fat]:[protein+carbohydrate].Carbohydrate is limited to 10-30 g / day.
15963783|NCT03160586|Diagnostic Test|Stuttering severity instrument-3|To measure of degree of stuttering in child
15963784|NCT03160586|Diagnostic Test|Child Behavior Checklist for age 4-18|To measure of percent of anxiety in child by ask parents about his or her behaviour
15963785|NCT03160573|Drug|ClōSYS® Unflavored Rinse|
15963786|NCT03160573|Drug|ClōSYS® Flavored Rinse|
15963787|NCT03160573|Other|Placebo-Flavored Oral Rinse|Flavor-matched placebo rinse
15963788|NCT03160573|Other|Placebo-Unflavored Oral Rinse|Unflavored-matched placebo rinse
15963789|NCT03160560|Drug|ClōSYS® Unflavored Rinse|Subjects in Test group will receive ClōSYS® Unflavored Rinse.
15963790|NCT03160560|Drug|ClōSYS® Flavored Rinse|Subjects in Test group will receive ClōSYS® Flavored Rinse.
15963791|NCT03160560|Other|Placebo|Subjects in Placebo group will receive Placebo Rinse.
15963792|NCT03160547|Other|Usual Protein/Amino Acid Group|Protein targets will be set using pre-ICU dry actual weight. For patients with BMI >30, ideal body weight based on a BMI of 25 will be used. We will endorse the guidelines for energy targets set forth by ASPEN/SCCM, especially as it pertains to the obese patient.
15963793|NCT03160547|Other|Higher Protein/Amino Acid Group|Protein targets will be set using pre-ICU dry actual weight. For patients with BMI >30, ideal body weight based on a BMI of 25 will be used. We will endorse the guidelines for energy targets set forth by ASPEN/SCCM, especially as it pertains to the obese patient.
15963794|NCT03160534|Other|preoperative exercise|Each intervention session contains a stretching part and aerobic training
15963795|NCT03160521|Drug|Risperidone ISM 75 mg|Monthly IM injection in the gluteal or deltoid muscle.
15963800|NCT03160482|Diagnostic Test|Immunohistochemistry|Immunohistochemistry procedure on the formalin-fixed, paraffin-embedded tissue.
15963801|NCT03160469|Device|intragastric Elipse Device|"Obesity prevalence is increasing worldwide, and Kuwait is currently considered to be the country with the most obese population1. Accordingly, standardization of the weight loss procedures has been made according to the Body Mass Index (BMI), keeping the more advanced surgeries for class II obesity (BMI 35- 39.9) and above, with consideration of other factors like, for example, obesity-related comorbidities. For those patients whom considered in the category of overweight (BMI = 25- 29.9) & class I obesity (BMI 30- 34.9), after failure of diet attempts, the weight loss options are limited. Of the highly requested options are the various types of intra-gastric balloons. Conventional endoscopic gastric balloons have proven to be safe and effective, with Excess Weight Loss (%EWL) of 25-50%2. A new swallowable gastric balloon, named Elipse, has been launched recently in Kuwait and became highly popular due to its unique concept of being procedure-less."
15963802|NCT03160456|Device|Transcutaneous electrical stimulation|The device needs to be started by pressing the 'on' button. Once the device is turned on the current intensity can be increased by pushing the '+' button and lowered by pushing the '-' button. When a comfortable skin sensation is felt the patients should press the '-' button once more. At that time the device stimulates with a low current which is not felt but provides a neuromuscular tone to the muscles whilst asleep. The device is kept on all night and in the morning taken off with the hydrogel and disconnected. Once disconnected it should be turned off by pressing the 'off' button.
15963803|NCT03160456|Device|Continuous positive airway pressure|CPAP will be applied according to usual clinical care, the follow up will be organised in the same way as the active intervention group.
15963804|NCT03160443|Behavioral|Ambulatory cares in a day-hospital (University Hospital of Montpellier) specialized in the evaluation of eating disorders|"All patients assessed in the day-hospital will performed the same evaluation :
~Blood sampling
~Calorimetry
~Osteodensitometry
~Psychiatric assessment
~Endocrinologic assessment
~Dietetic assessment
~Neuropsychological assessment
~Self-questionnaires
~With the patient agreement, a biological collection will be constituted. The objective is the subsequent study of biological factors involved in eating disorders (in particular genetic factors)"
15963805|NCT03160430|Drug|apabetalone|RVX000222 oral (apabetalone), 100 mg capsule
15963806|NCT03160430|Drug|Placebos|matching placebo capsule
15963807|NCT03160404|Drug|Zolpidem|The ZOLPIDEM group will be treated with zolpidem 10mg/night
15963808|NCT03160404|Behavioral|Exercise|The EXERCISE group will participate in an aerobic exercise program, performed in intensity relative to 50% of reserve heart rate, on a treadmill.
15963809|NCT03160391|Behavioral|Music Training|Training curriculums were developed using guidelines set by the Ontario Ministry of Education (The Ontario Curriculum, 2009) for teaching music to grades 1 to 3. Music was delineated into duration, pitch, dynamics and other expressive controls, timbre, texture/harmony, and form. training included direct instruction and group activities. All training programs had the same structure: a warm-up period, following by instruction from a teacher, and then group activities to practically demonstrate the concepts learned. Both programs involved working towards a variety of ensembles.
15963810|NCT03160391|Behavioral|Dance Training|As with music training, dance was operationally defined by fundamental concepts for the art form, namely elements for body, space, time, energy, and relationship. The intervention involved both individual and group activities, with a combination of instruction and practical activities, and preparation for a final performance.
15963811|NCT03160378|Behavioral|Organizational skills training|10 sessions of parent and child training in a group format.
15963812|NCT03160378|Other|Treatment as usual|Treatment as usual in the outpatient clinic
15963813|NCT03160365|Procedure|ACQUISITION OF IMAGES|In addition to the conventional clinical protocol, 4 MRIs qere performed at Day 0, day 1,day 15 and day 30 and a preoperative CT scan without injection of a contrast agent.
15963814|NCT03160352|Other|Exergame|In total, 10 sessions were accomplished including baseline and post intervention measurements. The remaining eight exercise sessions lasted 40 minutes, with an actual training duration of 20 minutes. This resulted in a cumulative total intervention exercise time of 160 minutes.
15963815|NCT03160339|Biological|PXVX0047 Vaccine|PXVX0047 is a live Adenovirus Type 4 (Ad4) / Adenovirus Type 7 (Ad7) vaccine for single-dose oral administration. The Ad4 and Ad7 strains in PXVX 0047 are unattenuated strains propagated in A549 human adenocarcinomic alveolar basal epithelial cells.
15963816|NCT03160339|Biological|Teva Ad4/Ad7 Vaccine|Teva Ad4/Ad7 is a live Adenovirus Type 4 (Ad4) / Adenovirus Type 7 (Ad7) vaccine for single-dose oral administration. The Ad4 and Ad7 strains in Teva Ad4/Ad7 are unattenuated strains propagated in WI-38 human diploid fibroblast cells.
15963817|NCT03160313|Behavioral|InFuSE|Each session includes a 45-minute education and group discussion. A 60-minute exercise component then completes the session. Each topic was specifically picked and tailored to benefit Veterans with TBI. The education sessions will be led and moderated by different professionals including physical therapists, recreation therapists, and physicians. Participants will be asked to participate in several learning activities. The activities are included to help improve understanding and promote group discussion. The exercise piece consists of a warm-up, endurance training (20-30 minutes), strengthening (15 minutes), balance/cognitive training (15 minutes), and a cool-down.
15963818|NCT03160313|Behavioral|Patient Education/Group Discussion|Each week you will participate in a 1 hour health education class with other Veterans. Each topic was specifically picked and tailored for Veterans with TBI. These education sessions will be led and moderated by different professionals including physical therapists, recreation therapists, and physicians. Participants will be asked to participate in several learning activities which are included to help improve understanding and promote group discussion.
15963819|NCT03160300|Device|Music with Binaural Beats|Relaxing music with embedded binaural beats at a frequency of 5 Hz
15963820|NCT03160300|Device|Music|Relaxing music without a binaural beat component
15963821|NCT03160287|Behavioral|Motivaltional interviews and infrequent motivational text messages|A self-management intervention will integrate use of mobile technology to prompt older adults to be physically active, provides ongoing monitoring of the amount of their physical activity and includes self-efficacy enhancements is a novel non-pharmacological intervention both for prevention and treatment of sleep deficiency in persons with OA
15963822|NCT03160274|Genetic|Genetic screening|Germline and/or tumor samples will be screened for mutations
15963824|NCT03160248|Drug|Apremilast|This study aims on investigating the efficacy of Apremilast in nummular eczema patients.
15963825|NCT03160248|Drug|Placebo Oral Tablet|This study aims on investigating the efficacy of Apremilast in nummular eczema patients - placebo controlled
15963829|NCT03160222|Other|Body Composition Measurements|Body composition measurements comprise the ultrasound measurement of fat and muscle thickness of both upper arms and thighs, the bioelectrical impedance analysis (BIA), measurement of weight, handgrip strength, overall muscle strength (Medical Research Council scale) and questionnaires about physical activity, nutrition and fluid status.
15963830|NCT03160196|Other|Clinical Decision Support System|It is about a Clinical Decision Support System based on a diabetes mellitus clinical practice guideline.
15963831|NCT03160196|Other|Usual care based on clinical practice guideline|It is about usual care aligned with the diabetes guideline.
15963832|NCT03160170|Device|SISTER device|Use of the Suction-Integrated Surgical Tissue Elevator & Retractor (SISTER) device during surgery
15963833|NCT03160144|Procedure|open lung approach|
15963834|NCT03160131|Device|Neuro Vision Technology|Training using Neuro Vision Technology
15963835|NCT03160118|Drug|Seasonal,quadrivalent,influenza vaccine|1 dose to be administered on Day 0, the first visit
15963836|NCT03160105|Drug|Switch to DTG + FTC|Switch from standard cART to DTG + FTC dual maintenance therapy.
15963837|NCT03160105|Other|Patient-centered monitoring|Immunological and safety blood examinations performed only once per year at least one options (decentralised venipuncture and blood tests, delivery of ARV drugs by mail and interview by phone or skype call) for weeks 6, 12 and 36
15963838|NCT03160092|Other|Intervention|"The intervention aims to:
~Support the participant to explore their unusual experiences
~Reduce the distress or anxiety participants feel in response to their unusual experiences, through:
~Helping them to recognise how common these unusual experience
~Supporting them to make sense of their unusual experiences
~Supporting them to understand why they may be experiencing these symptoms
~Challenging any unhelpful beliefs they hold about their symptoms
~Help the participant to recognise the triggers to their unusual experiences
~Support the participant to increase their activities and socialisation
~The intervention is not aiming to 'get rid' of the participant's symptoms, but to reduce their distress in response to them, which may result in improved wellbeing and reduced symptoms."
15963839|NCT03160079|Drug|blinatumomab|"Cycle 1 Blinatumomab Day 1-7 Continuous IV infusion for 28 days (9 mcg/day) Blinatumomab Day 8-28 Continuous IV infusion for 28 days (28 mcg/day)
~Cycle 2-5 Blinatumomab Day 1-28 Continuous IV infusion for 28 days (28 mcg/day)
~Cycle length 42 days"
15963840|NCT03160079|Drug|pembrolizumab|"Cycle 1 Pembroluzumab Day 15 and 36 IV infusion over 30 minutes (200mg)
~Cycle 2-5 Pembroluzumab Day 15 and 36 IV infusion over 30 minutes (200mg)"
15963841|NCT03160066|Dietary Supplement|Lactobacillus Rhamnosus (JB-1)|Lactobacillus Rhamnosus (JB-1) capsule
15963842|NCT03160066|Dietary Supplement|Placebo|Placebo
15963843|NCT03160053|Device|NB-UVB|NB-UVB has an emission spectrum in the ultraviolet B range of 290-320 nm. The system consists of a light source, a spot handpiece, and a light guide that connects the handpiece to the light source. The light source has a Start/Stop switch for light beam activation. Activation can also be controlled remotely with a foot switch. The light source has a timer and an output level control to adjust the intensity of the ultraviolet light. This will be calibrated using a manufacturer-provided UV meter prior to every treatment to ensure accurate doses of ultraviolet light.
15963844|NCT03160040|Drug|Minocycline IV|This study is an observational study. All participants were administered minocycline IV prior to enrollment in this study.
15963845|NCT03160027|Device|Vielight Neuro Gamma|The Vielight Neuro Gamma is headset that delivers transcranial (through the scalp and skull) and intranasal (through the nose) near infrared (NIR) light. The device is engineered for increased efficacy and easy domestic use for comprehensive brain photobiomodulation (PBM). The NIR lights are pulsed at a 40 Hz rate, which correlates with electroencephalogram (EEG) gamma brain wave entrainment.
15963846|NCT03160014|Drug|SHR3824|Drug: SHR3824 20mg/day, oral tablet, single dose
15963847|NCT03160001|Drug|Placebo|Patients with active RA and receive Etanercept for 8 weeks.: Placebo lactose 500mg cap twice daily
15963848|NCT03160001|Drug|Niclosamide|Patients with active RA and receive etanercept with niclosamide cap 500mg twice daily orally as adjuvant therapy for 8 weeks
15963849|NCT03160001|Drug|Etanercept|Etanercept 50mg weekly
15963850|NCT03159988|Drug|Angiotensin-(1-7)|Angiotensin-(1-7) 100mcg/kg/day for 12 weeks
15963851|NCT03159988|Behavioral|Memory Training|50% of the treatment arm will receive 2 session per week for 2 weeks of memory training
15963852|NCT03159975|Drug|GX-70 by electroporation|Gx-70 0.26mg will be administered by electroporation in the deltoid muscles every 4 weeks 5 times
15963853|NCT03159975|Drug|GX-70 by electroporation|Gx-70 1mg will be administered by electroporation in the deltoid muscles every 4 weeks 5 times
15963854|NCT03159975|Drug|GX-70 by electroporation|Gx-70 4mg will be administered by electroporation in the deltoid muscles every 4 weeks 5 times
15963855|NCT03159962|Device|Bonded RME (Rapid Maxillary Expander) appliance|"The expansion screw was activated 1 quarter of a turn per day (0.25 mm per turn) until the palatal cusps of the maxillary posterior teeth approximated the lingual cusps of the mandibular posterior teeth.
~The expander was kept in place as a passive retainer for 8 months. After expander removal, patients were followed without performing any additional treatment for 4 months."
15963856|NCT03159962|Device|Banded RME (Rapid Maxillary Expander) appliance|"The expansion screw was activated 1 quarter of a turn per day (0.25 mm per turn) until the palatal cusps of the maxillary posterior teeth approximated the lingual cusps of the mandibular posterior teeth.
~The expander was kept in place as a passive retainer for 8 months. After expander removal, patients were followed without performing any additional treatment for 4 months."
15963857|NCT03159949|Other|REHIIT|REHIIT participants will come into the lab one time per training days (3 training days per week), each session lasting 10 minutes. Training sessions involve a two-minute warm-up, 3 X 20-second cycling sprints on an exercise bike with three minutes rest in between, and a one-minute cool-down.
15963926|NCT03159403|Drug|Oritavancin|This study is an observational study. All participants were administered oritavancin prior to enrollment in this study.
15963927|NCT03159390|Other|phenylacetate salt of ornithine|
15963858|NCT03159949|Other|PR-REHIIT|"PR-REHIIT participants will come into the lab on 3 separate occasions on the training days, which occur 3 days per week (i.e., 9 sessions per week). Each session lasts 3 minutes and 20 seconds and consists of a two-minute warm-up, a 20-second all-out sprint on a cycle ergometer, and a one-minute cool-down. There will be 1-4 hours of rest in between training sessions where participants are free to leave the lab and go about their normal day."
15963859|NCT03159936|Biological|Tofacitinib citrate|10 mg daily by mouth
15963860|NCT03159923|Other|Moderate to severe tricuspid regurgitation (≥ 2/4) diagnosed with echocardiography in patients stabilized.|Moderate to severe tricuspid regurgitation (≥ 2/4) diagnosed with echocardiography in patients stabilized.
15963861|NCT03159910|Behavioral|Shoulder-Café|Education and individual counselling, clinical examination, supervised shoulder exercise. Some participants can be offered a workplace visit.
15963862|NCT03159910|Behavioral|Shoulder-Guidance|Home-based shoulder exercise and written counselling.
15963863|NCT03159897|Drug|Doxorubicin|Comparator arm: cycle 1-2 (and eventually 3-6): 25 mg/m2 i.v. days 1,15. Experimental arm: Cycles 1 to 4: 35 mg/m2 i.v. days 1,11. Cycles 5 and 6: 25 mg/m2 i.v. days 1,11.
15963864|NCT03159897|Drug|Bleomycin|Bleomicina Comparator arm: cycle 1-2 (and eventually 3-6): 10,000 units/m2 i.v. days 1,15. Experimental arm: cycles 1 to 4: 10,000 units/m2 i.v. days 1,11. Cycles 5 and 6: 10,000 units/m2 i.v. days 1,11.
15963865|NCT03159897|Drug|Vinblastine|Vinblastina Comparator arm: cycle 1-2 (and eventually 3-6): 6 mg/m2 i.v. days 1,15. Experimental arm: cycles 1 to 4: 6 mg/m2 i.v. days 1,11. Cycles 5 and 6: 6 mg/m2 i.v. days 1,11.
15963866|NCT03159897|Drug|Dacarbazine|Dacarbazina Comparator arm: cycle 1-2 (and eventually 3-6): 375 mg/m2 i.v. days 1,15. Experimental arm: cycles 1 to 4: 375 mg/m2 i.v. days 1,11. Cycles 5 and 6: 375 mg/m2 i.v. days 1,11.
15963867|NCT03159884|Drug|Conbercept|
15963868|NCT03159871|Device|Stratafix suture|Stratafix barbed sutures during C-Sections.
15963869|NCT03159871|Device|Vicryl suture|Standart Vicryl suture during C- Sections.
15963870|NCT03159858|Device|Fenerated AAA Endovascular Graft with H&L-B One Shot Introduction System|The Compassionate Use Request is for the use of the Cook Zenith Fenestrated Endovascular Graft (4 branches) for the treatment of a 70-year-old male patient considered unfit for open surgical repair of his 6cm paravisceral abdominal aortic aneurism (AAA).
15963871|NCT03159845|Drug|Zinc Sulfate Oral Product|
15963872|NCT03159845|Drug|Levofloxacin 500Mg Oral Tablet|once daily from day +10 until day +30 after stem cell transplantation
15963873|NCT03159845|Drug|Fluconazole 200mg tab|twice daily from day +10 until day +30 after stem cell transplantation
15963874|NCT03159845|Drug|Acyclovir 400 MG|twice daily from day +10 until day +30 after stem cell transplantation
15963875|NCT03159832|Drug|SHR3824|All subjects were given SHR3824 20mg only one time.
15963876|NCT03159819|Genetic|CAR-CLD18 T Cells|Dose escalation will be applied in this study.
15963877|NCT03159806|Device|Microdialysis sampling|Insertion of CE-marked intravenous microdialysis catheter, use of CE-marked microdialysis pump to collect intravenous microdialysis samples
15963878|NCT03159793|Behavioral|Live Modelling Technique|Direct observation is the term used to describe both the filmed and live modelling technique. These techniques depend on familiarizing the patient with the dental environment and allowing the patient to ask the questions he/she wants to ask. The patients are shown a film or are permitted to directly observe a cooperative patient undergoing dental treatment. These techniques have no contra indications they simply may be used with any patient.
15963879|NCT03159793|Behavioral|Filmed Modelling technique|Direct observation is the term used to describe both the filmed and live modelling technique. These techniques depend on familiarizing the patient with the dental environment and allowing the patient to ask the questions he/she wants to ask. The patients are shown a film or are permitted to directly observe a cooperative patient undergoing dental treatment. These techniques have no contra indications they simply may be used with any patient.
15963880|NCT03159767|Device|ViMove Spinal Sensor|Sensors will be used to measure spinal movement
15963881|NCT03159754|Procedure|Early Appendectomy|Removal of the appendix within 24 hours of admission
15963882|NCT03159754|Procedure|Interval Appendectomy|Removal of the appendix after initial antibiotic treatment and at least 6 weeks of recovery.
15963883|NCT03159754|Drug|Antibiotics|Zosyn will be administered unless the patient has a penicillin allergy, in which case patients will receive both ciprofloxacin and metronidazole.
15963884|NCT03159741|Other|Inhibitor + GLP-2|Inhibitor and GLP-2 are used as study tools.
15963885|NCT03159741|Other|Placebo + GLP-2|Placebo and GLP-2 are used as study tools.
15963886|NCT03159741|Other|Placebo + GIP|Placebo and GIP are used as study tools.
15963887|NCT03159741|Other|Placebo + Saline|Placebo
15963888|NCT03159728|Behavioral|Educative intervention:|"In the induction of the new group members are present, including caregivers who start the program and those who coordinated.
~In Module I: to strengthen the knowledge of the situation and the people involved in care.
~In Module II: to strengthen the value in the caregiver through decision making, skill and social support to back it up.
~In Module III: or end, after analyzing that uneasy caregiver, patience is reviewed through the meaning of family care and self."
15963889|NCT03159715|Behavioral|Internet-based Global Protocol|Internet-based Global Protocol is an Internet-based treatment which includes therapeutic components of evidence-based treatments for depression: Motivation, Psychoeducation, Cognitive Therapy, and Relapse Prevention. Furthermore, it incorporates a Behavioural Activation component (BA). The whole protocol stresses the importance and benefits of being active and remaining involved in life, values and goals. The program also includes a component of Positive Psychology (PP). It allows the individual to learn and practice adaptive ways to cope with depressive and anxiety symptoms and confront daily problems. It is a multimedia (video, image, etc.) interactive program designed for optimal use on the computer, but it can also be used on a tablet.
15963890|NCT03159715|Behavioral|Internet-based Behavioral Activation Protocol|Internet-based Behavioral Activation Protocol is an Internet-based treatment based on Behavioral Activation. It stresses the importance and benefits of being active and remaining involved in life, values and goals . It is a multimedia (video, image, etc.) interactive program designed for optimal use on the computer, but it can also be used on a tablet.
15963953|NCT03159156|Behavioral|Applied Tension/Respiration Control|Described above.
15964035|NCT03158454|Procedure|Non-Capsula Closure|No capsular closure procedure is performed.
15963891|NCT03159715|Behavioral|Internet-based Positive Psychology Protocol|Internet-based Positive Psychology Protocol is an Internet-based treatment based on Positive Psychology, offering strategies to promote and enhance positive mood. It is an Internet-based treatment based on Positive Psychology. It is a multimedia (video, image, etc.) interactive program designed for optimal use on the computer, but it can also be used on a tablet.
15963892|NCT03159702|Drug|Evomela|140 mg/m^2/day IV on Day -6 for patients who are < 60 years of age. 70 mg/m^2/day IV on Day -6 For patients who are ≥60 years or have a HCT-CI score of >3
15963893|NCT03159702|Drug|Fludarabine|40 mg/ m^2/day intravenous on Days: -5 -4, -3, -2
15963894|NCT03159702|Radiation|Total Body Irradiation|200 cGy on Day: -1
15963895|NCT03159689|Other|Mixed Tree Nuts|Individuals on a hypo caloric weight loss dietary plan supplemented with 1.5oz mixed tree nuts
15963896|NCT03159689|Other|Pretzels|Individuals on a hypo caloric weight loss dietary plan supplemented with 1.5oz pretzels
15963897|NCT03159676|Radiation|Proton beam|Proton beam
15963898|NCT03159650|Device|intravascular ultrasonography|intravascular ultrasonography will be used during the study for the resolving proximal cap ambiguity of chronic total occlusion, facilitating re-entry into the true lumen after subintimal crossing and confirming distal true lumen guidewire position
15963899|NCT03159637|Procedure|Laparoscopic Surgery|Insufflation of a gas (carbon dioxide) into the peritoneal cavity producing a pneumoperitoneum will be done. The positioning of the patients in Trendelenburg position will be done. intraoperative and postoperative outcomes will be assesed
15963900|NCT03159624|Other|Biodesign™ SIS graft|2x3 cm Biodesign™ SIS perforated mesentery graft
15963901|NCT03159624|Other|Doyle silastic sheet|Doyle silastic sheet
15963902|NCT03159611|Drug|Tenoten for children|Oral. 10 drops daily, at the same time in the morning, 15 minutes before feeding.
15963903|NCT03159611|Drug|Placebo|Oral. 10 drops daily, at the same time in the morning, 15 minutes before feeding.
15963904|NCT03159598|Device|Tissue Glu|Once adequate hemostasis has been achieved during surgery and the abdominal fascia and flaps have been irrigated, Tissue Glu will be applied. Tissue Glu is applied at approximately one centimeter intervals while remaining one centimeter away from the umbilicus and inferior incisions.
15963905|NCT03159598|Device|Drain|Drains will be placed during surgery to allow for the drainage of seroma which may develop after surgery
15963906|NCT03159598|Other|Questionnaires|Questionnaires given to patients pre-and post surgery to determine pain, impact of breast reconstruction on activity, and impact of breast reconstruction on caregivers
15963907|NCT03159585|Drug|TAEST16001|After completion of Lymphodepleting regimen pretreatment, the subject will receive an infusion of TAEST16001
15963908|NCT03159559|Drug|Lipo-PGE1|Patients received conventional therapy plus Lipo-PGE1 10μg once daily intravenous injection for 7 days
15963909|NCT03159546|Device|Device: FreeStyle Libre Flash Glucose Monitoring System|Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System and will receive no treatment except for safety purposes.
15963910|NCT03159533|Behavioral|CHW Intervention|Patients randomized to Group A will be invited to attend 4 more group educational sessions on self-management immediately.CHWs will follow up with participants by phone or in person through a home or clinic visit. At these follow-up meetings, CHWs will engage in goal-setting activities regarding changes to health behaviors, medication adherence, or other issues related to hypertension control as identified jointly by the patient and CHW. CHWs will also collect height, weight, and blood pressure measurements at initial and in-person follow-up visits. The CHW will make necessary referrals to other services available in the community (i.e. exercise classes, social services, mental health, tobacco cessation, etc.).
15963911|NCT03159533|Behavioral|Wait List Control Group|4 education sessions beginning 6-12 months later.
15963912|NCT03159520|Behavioral|Advice sheet|Advice on management of post orthodontic pain
15963913|NCT03159507|Dietary Supplement|MAG-EPA|Based on the result of the participant's Omega-3 index obtained from the blood sampling of visit 1, the daily dose of MAG-EPA will be adjusted to obtain an Omega-3 Index of 8.
15963914|NCT03159494|Other|High-Intensity Training|"8 times of Hit consisting of 3 minutes of Warm-up on an indoor bike followed by 10 intervals of 1 minute at 90% og HRmax interspersed of 1 minute of recovery.
~As for the pilot study 6 times of training were completed"
15963915|NCT03159481|Behavioral|Usual Care + Health Promotion Intervention|Telephone sessions for approximately 5-6 weeks to enhance empowerment and skills for managing medication adherence.
15963916|NCT03159468|Behavioral|Cognitive Restructuring|Participants receive didactic instruction regarding cognitive restructuring skills and then practice using these skills in hypothetical situations.
15963917|NCT03159468|Behavioral|Mindfulness|Participants receive didactic instruction regarding mindfulness skills and then practice using these skills in hypothetical situations.
15963918|NCT03159468|Other|Alcohol consumption|Participants consume an alcoholic beverage in the lab.
15963919|NCT03159455|Drug|BI 1467335|Duration - 28 days
15963920|NCT03159455|Drug|Placebo|Duration - 28 days
15963921|NCT03159442|Drug|AZD8871|Powder for inhalation administered via single dose DPI 300 and 600 µg/inhalation.
15963922|NCT03159442|Drug|Placebo|Powder for inhalation administered via single dose DPI
15963923|NCT03159429|Behavioral|Standard rehabilitation|The patient will participate in a therapeutic education programme consisting of 4 visits (days 1 +- 14, 21 +- 14, 61 +- 14 and 90 +-14) representing usual procedures, which include: maintaining a diary, breathing coordination excercises, voluntary control of breathing rate, releasing contracted muscles, posture harmonization, a six minute walking test, and walking up four flights of stairs.
15963924|NCT03159429|Behavioral|Nasal breathing rehabilitation|The patient will participate in a therapeutic education programme consisting of 4 visits (days 1 +- 14, 21 +- 14, 61 +- 14 and 90 +-14) representing the experimental procedures, which include: maintaining a diary, evaluating nasal breathing by the nostril-alternating technique according to Anuloma Viloma Pranayama Yoga, releasing contracted muscles, posture harmonization, a six minute walking test, and walking up four flights of stairs.
15963925|NCT03159416|Drug|Inclisiran|Inclisiran is a synthetic, chemically modified small interfering ribonucleic acid (siRNA) targeting proprotein convertase subtilisin kexin type 9 (PCSK9) messenger ribonucleic acid (mRNA) with a covalently attached triantennary N-acetylgalactosamine (GalNAc) ligand.
15964000|NCT03158792|Drug|Enoxaparin 20Mg/0.2mL Prefilled Syringe|Enoxaparin 20mg subcutaneously once daily
15963928|NCT03159377|Device|Ultra low dose chest CT|Performing an ultra low dose chest CT (ULDCT) in addition to a clinically indicated chest CT and assessing nodule detection with a recently developed denoising algorithm
15963929|NCT03159364|Biological|pathogen-specific CTLs|Patients will receive approximately 1x10^5~1x10^6 CTLs/kg as a single infusion via IV injection and may receive additional infusions.
15963930|NCT03159351|Device|active rTMS treatment|active rTMS treatment protocol parameters: localization of left DLPFC: frequency=10 Hz, intensity=110% motor threshold(MT), times per train=200 seconds, trains=10, duration= 40 seconds, total times=20;localization of right DLPFC: frequency=1 Hz, intensity=100%MT, times per train=30 seconds, trains=10, duration= 10 seconds, total times=20.
15963931|NCT03159351|Device|sham rTMS treatment|sham rTMS treatment protocol parameters: sham rTMS treatment in the localization of left DLPFC and right DLPFC for 30 minutes,total times=20.
15963932|NCT03159338|Biological|Platelet rich fibrin|Platelet rich fibrin will be prepared by taking 20 cc blood and centrifugation with 28000 rpm.
15963933|NCT03159338|Biological|Placebo|In control group , after spliting the osteotomy site before fixation a placebo gel will be placed
15963934|NCT03159325|Behavioral|Healing Circles|See description in the arm description.
15963935|NCT03159312|Behavioral|Physical activity based on a moderate exercise program|Physical exercise program begins with a 2-week adaptation stage, climbs onto the treadmill (HP Cosmos®). The programming of the tape will be done initially with an intensity of 40% of its FCdRes obtained from the formula of Karvonen after performing the 6-minute walk test, you will have to maintain that intensity for 15 min, the patient is evaluated with the Borg scale and oxygen saturation permanently.After two weeks of adaptation, the HRdRes becomes to be calculated, 59% of said frequency will be modified until the exercise program is completed.The training is 30 minutes in the tradmill machine.The work of muscle strengthening of biceps, triceps, deltoids and pectorals, will be progressive in intensity and number of repetitions, determined by the evaluation of 1 Rmax. The start of work with weights is 40% of the Rmax, it will be modified monthly from 40% to 75%. Cycloergometer training (Monark ®) is without load for 15 minutes.
15963936|NCT03159299|Behavioral|Yo Puedo + mHealth|This intervention is an adapted diabetes self-management education program. Study participants will attend group classes weekly for 6 weeks, and receive daily text messages over 6 months.
15963937|NCT03159286|Behavioral|Abstainer|Participants view social networking site profiles with alcohol content referencing abstaining from alcohol use.
15963938|NCT03159286|Behavioral|Abstainer + User|Participants view social networking site profiles with alcohol content referencing abstaining from alcohol use and using alcohol.
15963939|NCT03159286|Behavioral|Control|Participants view social networking site profiles with no alcohol content.
15963940|NCT03159273|Dietary Supplement|Beetroot Juice Group|Beetroot juice drink- 7 daily doses (70 ml, containing 0.4-0.5 mg nitrate) taken over a week
15963941|NCT03159260|Device|Theraworx|Subjects will be instructed to apply the topical foam they have been assigned to their entire upper and lower legs and feet using 8 pumps from the product dispenser per leg (upper thigh to foot) before retiring each evening for the next 14 days. If subjects experience leg cramps or spasms after retiring they will be instructed to reapply to 2 pumps of the foam to the affected area in response to each event. Each morning during the 14 days in which subjects apply the foam they will be asked to complete the Compliance and Symptom Log that documents the incidence and severity of night-time cramps and spasms their use of the foam and any other therapies they used to treat their night-time cramps and spasm.
15963942|NCT03159260|Other|Placebo|Subjects will be instructed to apply the topical foam they have been assigned to their entire upper and lower legs and feet using 8 pumps from the product dispenser per leg (upper thigh to foot) before retiring each evening for the next 14 days. If subjects experience leg cramps or spasms after retiring they will be instructed to reapply to 2 pumps of the foam to the affected area in response to each event. Each morning during the 14 days in which subjects apply the foam they will be asked to complete the Compliance and Symptom Log that documents the incidence and severity of night-time cramps and spasms their use of the foam and any other therapies they used to treat their night-time cramps and spasm.
15963943|NCT03159247|Behavioral|eyeGuide|The eyeGuide, a web-based tool to facilitate a personalized behavior change program for non-adherent glaucoma patients.
15963944|NCT03159234|Radiation|fetal lung volume|the best method for measurement of fetal lung volume is by the rotational technique in which each lung is obtained by serial contouring of the pulmonary area after rotating the volumetric image.this is more recent method seems to have advantages allowing finer contouring of the lung and subsequent modification of the contour as well as being better able to estimate the volumes of irregular and small lung as in congenital diaphragmatic hernia
15963945|NCT03159234|Radiation|pulmonary artery resistance index|Women placed in semirecumbent position and an axial plane through the fetal thorax to achieve 4 chamber view of the heart. The main pulmonary artery was followed to the point where it divides into right and left branches by rotating the transducer from the 4 chamber view to the short axis view of the heart. Pulsed and colour Doppler was used. The fetal pulmonary artery flow waveform measurements was taken within the proximal portion of the main pulmonary artery
15963946|NCT03159234|Radiation|Fetal adrenal gland volume:|the adrenal gland has a characteristic sonographic appearance; each limb is seen as a long anechoic structure with a thin, echogenic line within its center . Both limbs can sometimes be seen in the coronal plane, and if so there is a strong echogenic line between limbs (probably fat). On the basis of pathologic and histologic studies , we believe the anechoic bulk of the gland represents the fetal zone of the cortex, while the central echogenic core is the medulla.
15963947|NCT03159221|Behavioral|BFST for Teens with Type 2 Diabetes|BFST for Teens with Type 2 Diabetes: 12 (90 minute sessions) over 6 months of Behavioral Family Systems Therapy (BFST), delivered by a Licensed clinical social worker. BFST consists of 4 components: problem-solving, communication skills training, cognitive restructuring, and functional and structural family therapy.
15963948|NCT03159182|Device|Pressure garment and silicone insert|Custom made fabric pressure garment with textile bonded silicone insert on either proximal or distal portion of pressure garment.
15963949|NCT03159182|Device|Pressure garment|Custom made fabric pressure garment
15963950|NCT03159169|Device|Spinal Cord Stimulation (SCS)|Implantation of SCS electrodes and stimulator according to clinical standards
15963951|NCT03159156|Behavioral|Applied Tension|Described above.
15963952|NCT03159156|Behavioral|Respiration Control|Described above.
15963954|NCT03159143|Drug|Docetaxel|Docetaxel (28) is a semi-synthetic taxane which blocks mitosis by preventing microtubule depolymerization. It mediates its actions by binding to a different set of microtubule-associated proteins than paclitaxel. It is administered every 3 weeks as a 30 minute infusion at doses between 60 to 75 mg/m^2.
15963955|NCT03159143|Drug|Oxaliplatin|Alkylating antineoplastic agent. It is administered on day 1 of each cycle at a dose of 110 mg/m^2
15963956|NCT03159117|Drug|PF-06688992|(PF-06688992) will be administered on Day 1 of each 21-day cycle per the Dose Preparation and Administration Instructions (DAI) located in the Investigational Product Manual (Appendix 4Appendix 3) as an IV infusion over approximately 60 minutes. A cycle is defined as the time from Day 1 dose to the next Day 1 dose. If there are no treatment delays, a cycle will be 21 days. Each patient may receive PF-06688992 until disease progression, unacceptable toxicity, withdrawal of consent, or study termination
15963957|NCT03159104|Drug|Tenoten for children|Oral administration.
15963958|NCT03159104|Drug|Placebo|Oral administration.
15963959|NCT03159091|Drug|Rengalin|Oral administration.
15963960|NCT03159091|Drug|Placebo|Oral administration.
15963961|NCT03159078|Drug|Polymyxin B|Comparison of Poly B monotherapy vs Polymyxin B plus carbapenem in MDR infections
15963962|NCT03159065|Other|Bilberry|Fruit beverage with bilberry and fermented oatmeal
15963963|NCT03159065|Other|Blackcurrant|Fruit beverage with blackcurrant and fermented oatmeal
15963964|NCT03159065|Other|Mango|Fruit beverage with mango and fermented oatmeal
15963965|NCT03159065|Other|Beetroot|Fruit beverage with beetroot and fermented oatmeal
15963966|NCT03159065|Other|Rose hip|Fruit beverage with rose hip and fermented oatmeal
15963967|NCT03159065|Other|Glucose drink|A reference glucose drink
15963968|NCT03159052|Drug|SHR3824|Once daily, 52 weeks
15963969|NCT03159052|Drug|Placebo|Once daily, 24 weeks
15963970|NCT03159039|Other|Conventional Physiotherapy|
15963971|NCT03159039|Other|Prolonged slow exhalation technique|Postural drainage associated with manual vibration and a mild pressure in the end of expiratory phase
15963972|NCT03159013|Other|Exposure|"Oral exposure: 0,025 mg/kg bw dissolved in oil, on day 1, with blood withdrawn on days 2,3,4.
~Dermal exposure: 145 µl of commercial formulation (0,25 mg/kg bw) on 40 cm2 of forearm skin for 6 hours, on day 28, with blood withdrawn on days 29,30,31."
15963973|NCT03159000|Drug|Saline|1ml of 1/3 saline
15963974|NCT03159000|Combination Product|lidocaine/bupivacaine|1ml of a 50% 2% lidocaine and 50% 0.5% bupivacaine
15963975|NCT03158987|Other|Medical record review|Review of medical records of patients diagnosed for the first time as HIV seropositivity
15963976|NCT03158974|Drug|East Indian Sandalwood Oil Cream|Cream containing 10% East Indian Sandalwood Oil (EISO)/Albuterpenoids
15963977|NCT03158961|Procedure|Transoral endoscopic thyroidectomy vestibular approach|TOVETA is a new approach in surgery of thyroidectomy no longer open on the neck
15963978|NCT03158948|Drug|MOTREM|Formulated LR12 peptide
15963979|NCT03158948|Drug|Placebo|placebo
15963980|NCT03158935|Drug|Cyclophosphamide|Cohort 1: i.v., 60mg/kg per day for 2 days Cohort 2: i.v., 30mg/kg per day for 2 days
15963981|NCT03158935|Drug|Fludarabine|Cohort 1: i.v., 25mg/m2 per day for 5 days
15963982|NCT03158935|Procedure|Pembrolizumab|Cohort 1 and 2: i.v., 200mg every 3 weeks
15963983|NCT03158935|Biological|Tumor-Infiltrating Lymphocytes (TILs)|Cohort 1 and 2: i.v., 1x10^10 - 1.6x10^11 cells
15963984|NCT03158935|Biological|Interleukin-2 (IL-2)|Cohort 1 and 2: i.v., 125,000 IU/kg subcutaneous per day
15963985|NCT03158922|Genetic|Genetic SNP profiling|Genetic SNP profiling of known prostate cancer predisposition SNPs will be performed on DNA extracted from saliva samples.
15963986|NCT03158922|Other|Prostate cancer screening|Prostate cancer screening in the form of PSA testing will be offered to all men who have a benign biopsy result for five years in order to track development of cancer in the future.
15963987|NCT03158922|Procedure|Prostate biopsy|Prostate biopsy will be offered to men identified within the top 10% genetic risk score profile.
15963988|NCT03158909|Device|Eyemask and earplugs|Eyemask and earplugs for use during the night, to improve sleep.
15963989|NCT03158909|Other|Orientation about space and time|Information and orientation about space and time, given every night.
15963990|NCT03158896|Biological|MSCTC-0010 Dose Escalation|"Cohort 1: 2.0 × 106 cells per kilogram (cells/kg) body weight, given on day 0 and on day 7 in Participants having de novo High Risk Acute or Steroid Refractory Acute Graft Versus Host Disease (HR/SR aGvHD)
~Cohort 2: 10 × 106 cells/kg of body weight, given on day 0 and on day 7 in Participants having de novo HR/SR aGvHD"
15963993|NCT03158870|Procedure|Surgery complications|Assessment of the influence of surgeon-anesthesiologist collaboration on surgery complications during and up to 30 days after pheochromocytoma surgery.
15963994|NCT03158857|Drug|Sofosbuvir 400 mg|These drugs are being offered as part of routine care
15963995|NCT03158844|Other|Standard of care|Routine standard of care per Ministry of Health protocol, including blood draws and examinations.
15963996|NCT03158831|Drug|Placebo-Controlled Graded Drug Challenge|All patients receive a placebo followed by 30 minutes of observation. Patients then receive 1/10 of the treatment dose of the challenge drug followed by 30 minutes of observation. If no reaction, they will then receive a full dose of their challenge drug followed by 1 hour of observation. If they do not experience any reactions, they are deemed not to be allergic. All patients are asked to monitor for delayed reactions after the challenge. Patients are also called within 1 month of the challenge to determine if any delayed reactions occurred. Patients are called again within 1 year of the challenge to determine if they have subsequently taken the challenge drug and experienced any reactions.
15963997|NCT03158818|Other|Standard of care|Routine standard of care per Ministry of Health protocol, including blood draws and examinations.
15963998|NCT03158805|Drug|LIRAGLUTIDE|3 Mg/0.5 mL (18 Mg/3 mL) SUB-Q PEN INJECTOR (ML)
15963999|NCT03158805|Other|Placebo|Placebo injection
15964001|NCT03158792|Drug|Enoxaparin 60Mg/0.6Ml Inj Syringe 0.6Ml|Enoxaparin 30mg subcutaneously once daily. Half of the graduated 60Mg/0.6Ml Inj Syringe is administered
15964002|NCT03158779|Combination Product|SBRT and chemotherapy|Patients affected by locally unresectable pancreatic cancer receive integrated treatment of FOLFIRINOX or Gemcitabine-Abraxane and a Stereotactic Body Radiation Therapy with a total dose of 54 Gy in 6 fractions of 9 Gy /fractions.
15964003|NCT03158766|Other|Microdiscectomy|It will be an observational study without interventions. Subjects with diagnose of lumbar disc herniation undergoing open decompression surgery (microdiscectomy) will be included and analyzed. There will be no direct intervention to the patient proposed by the study.
15964004|NCT03158740|Behavioral|DII-Based Counseling System|DII-Based Counseling System, including 12 weekly classes in reducing inflammation by adopting dietary patterns low in inflammation and also through physical activity and stress reduction. Participants will also have access to our Imagine Healthy Online Portal. Group-based behavior change programs provide a way for members to share successes and obtain and provide support to one another.
15964005|NCT03158740|Behavioral|general health education control|The standard of care arm will receive general health information (e.g., general guidelines of healthy eating and physical activity, stress management, cancer screening, etc.). This information will be provided through email, which will include a weekly newsletter, healthy recipes that are not focused on reducing the DII scores, links to online content, and health-related event announcements in and around Columbia, SC. Any participants in the standard of care arm who does not use email regularly may request for items to be mailed to their mailing address.
15964006|NCT03158727|Biological|Cx611|Two intravenous infusions, one on day 1 and another one on day 3.
15964007|NCT03158727|Other|Placebo|Two intravenous infusions, one on day 1 and another one on day 3.
15964008|NCT03158714|Behavioral|Couples Connecting Mindfully|
15964009|NCT03158714|Behavioral|ELEVATE|
15964013|NCT03158675|Procedure|fractional carbon dioxide(CO2) laser|-Fractional CO2 laser: Laser sessions will be performed at half month interval and it will be used with a wave length of 10,600nm.
15964014|NCT03158675|Drug|Topical corticosteroid|Topical corticosteroid will be applyed twice weekly on both sides for 4 months.
15964015|NCT03158675|Radiation|Ultraviolet B narrow band|Ultraviolet B narrow band will be performed (wave length ranged from 300 to 320nm).The sessions will be performed twice weekly for 4 months.
15964016|NCT03158662|Other|Survey|Survey Study
15964017|NCT03158649|Other|"Embarazo y Bienestar"|"The intervention programme is called Embarazo y Bienestar (Pregnancy and Well-being). Embarazo y Bienestar is a modular, self-placed program mainly designed to foster women's prenatal well-being by practicing some positive psychology-based exercises. The intervention programme consist of four modules of intervention, one welcome module, and a final resume page."
15964018|NCT03158623|Biological|Platelet Rich Plasma|
15964019|NCT03158623|Biological|Cellerate|
15964020|NCT03158610|Drug|Capecitabine|Oral fluorouracil
15964021|NCT03158584|Drug|Intrathecal Morphine|Intrathecal administration of Morphine in children undergoing major abdominal surgeries
15964022|NCT03158558|Behavioral|Accelerated, Multi-Couple Group CBCT for PTSD|Intensive weekend retreat version of cognitive-behavioral conjoint therapy for PTSD (Monson & Fredman, 2012)
15964023|NCT03158545|Dietary Supplement|Olive oil Placebo|olive oil
15964024|NCT03158545|Dietary Supplement|EPA-rich|EPA-rich omega-3 oil
15964025|NCT03158545|Dietary Supplement|DHA-rich|DHA-rich omega-3 oil
15964026|NCT03158532|Drug|Nitroglycerin I|500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.
15964027|NCT03158532|Drug|Placebo I|Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization.
15964028|NCT03158532|Drug|Nitroglycerin II|500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
15964029|NCT03158532|Drug|Placebo II|Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
15964030|NCT03158519|Behavioral|iMETX intervention|"Pre-intervention the participants will wear the running watch for 3 weeks so that researchers can collect data about their daily routines regarding where and how much energy they expend.
~During the intervention participants will wear the running watch for 12 weeks. Every 1-3 days the participants will be given an individualized recommendation for how to increase their activity via the iMETX application. Participants will be able to provide feedback to the researchers throughout intervention period regarding what works and does not in terms of the recommendations for increasing activity.
~Post-intervention the participants will wear the running watch for 12 weeks so that researchers can collect data in order to determine whether physical activity changes made during the intervention are sustained."
15964031|NCT03158506|Drug|HMS5552|[14C]-labelled HMS5552
15964032|NCT03158480|Biological|DC-CIK immunotherapy|Cytokine-induced killer (CIK) cells are co-cultured with HPV induced dendritic cells (DCs); HPV specific DC-CIK will be induced to condylomata acuminata patients
15964033|NCT03158467|Other|Surveys|Instruments will be administered via the online RedCAP platform. The survey instruments will include a Decision Conflict Scale (DCS), the McGill Quality of Life (MQoL), the Human Connection (THC), and a general demographics questionnaire. Patients will have the opportunity to complete the instruments via a research iPad while in clinic or via a survey link emailed to their private email account.
15964034|NCT03158454|Procedure|Capsula Closure|The capsular closure is performed with a minimum of two vicryl # 2 resorbable sutures
15964036|NCT03158441|Diagnostic Test|Breast MRI|comparison of DTI to dynamic MRI
15964037|NCT03158428|Other|CSD170202AA|A moist snuff product
15964038|NCT03158428|Other|CSD170202AB|A moist snuff product
15964039|NCT03158415|Behavioral|T1DToolkit.org mobile diabetes education|"Participants will receive a reminder via text and/or email twice per week to invite them to view diabetes education materials on the study's mobile website, T1DToolkit.org. Topics on this website include, among others, Caregiver Burnout; Your Child is Now an Adult; Sharing Responsibility; Sources of Support; Common Fears for Parents of Young Adults; and Your Child, Your Child's Doctor, and You.
~Six weeks after enrollment, participants will complete the Modified Diabetes Distress Scale: Parents of Young Adults."
15964040|NCT03158402|Other|Prehabilitation with inspiratory muscle training|3 to 6 weeks of two times a day inspiratory muscle training at 80% of the Maximum Inspiratory Pressure.
15964041|NCT03158389|Drug|APG101|weekly i.v.
15964042|NCT03158389|Drug|Alectinib|twice daily (oral)
15964043|NCT03158389|Drug|Idasanutlin|orally on 5 days of a 28 days cycle
15964044|NCT03158389|Drug|Atezolizumab|i.v. every 3 weeks
15964045|NCT03158389|Drug|Vismodegib|daily orally
15964046|NCT03158389|Drug|Temsirolimus|weekly i.v.
15964047|NCT03158389|Drug|Palbociclib|orally on 21 days of a 28 days cycle
15964048|NCT03158376|Drug|Gabapentin|
15964049|NCT03158376|Drug|Placebo|
15964050|NCT03158363|Other|LPS, 36 hour immobilization and fast|LPS endotoxin is administered on study day 1 and immobilization and fast continue throughout study day 1 and 2.
15964051|NCT03158350|Other|Instructed Brushing Method|Stationary Bristle Technique
15964052|NCT03158337|Behavioral|Aerobic exercise|
15964053|NCT03158324|Drug|OPB-111077|Receive 600 mg of OPB-111077 on a 4 days-on, 3 days-off per week in 28-day cycles till disease progression or intolerable toxicity
15964054|NCT03158311|Drug|QVM149|Indacaterol acetate / glycopyrronium bromide / mometasone furoate
15964055|NCT03158311|Drug|Salmeterol/fluticasone plus tiotropium|Free triple arm of salmeterol / fluticasone plus tiotropium
15964056|NCT03158298|Other|Specimen collection|Maternal blood sample of 10 ml collected by venepuncture upon delivery
15964057|NCT03158285|Drug|Guselkumab|Participants will receive 100 mg of guselkumab as a sterile liquid for SC injection.
15964058|NCT03158285|Drug|Placebo|Participants will receive matching placebo as SC injection.
15964059|NCT03158272|Biological|Cabiralizumab|Specified dose on specified days
15964060|NCT03158272|Biological|Nivolumab|Specified dose on specified days
15964061|NCT03158259|Other|Prehospital diagnosis and treatment|The patient will be diagnosed and treated by anesthesiologist in the mobile stroke unit (MSU). The diagnosis will be NIHSS, CT scans by a CT-scanner fitted in the MSU, and blood-analysis in a mobile lab inside the MSU. All performed by a three-person crew consisting of an anesthesiologist, paramedic and nurse-paramedic. The CT images will be sent to the lokal hospital and contact with neurologist in ward established. A decision to treat will be given in collaboration between the neurologist and anesthesiologist.
15964062|NCT03158246|Drug|Generic Zoledronic Acid|Generic Zoledronic Acid (Yigu®) 5mg/100ml injection
15964063|NCT03158246|Drug|Original Zoledronic Acid|Original Zoledronic Acid (Aclasta®) 5mg/100ml injection
15964064|NCT03158246|Dietary Supplement|calcium|600mg/d calcium for oral daily
15964065|NCT03158246|Dietary Supplement|vitamin D|925IU/d vitamin D for oral daily
15964066|NCT03158220|Biological|V503|V503 vaccination, 0.5 mL in a 3-dose regimen administered on Day 1, Month 2, and Month 6
15964067|NCT03158207|Device|Waters Mask|All anesthesiologists and CRNAs will view an instructional video on the use of the Warters Mask. Following induction of general anesthesia with the standard of care sequence of medications, each patient will then have mask ventilation performed and graded (Han and Warters Scales).
15964068|NCT03158207|Other|Standard Mask|Following induction of general anesthesia with the standard of care sequence of medications, each patient will then have mask ventilation performed and graded (Han and Warters Scales). Mask ventilation will be scored with both masks before and after the standard administration of paralytic medication.
15964069|NCT03158194|Behavioral|CBT for anxiety-related asthma|The specific assignments in the intervention will be based on individual behavior analysis for each participant.
15964070|NCT03158181|Other|Non interventional study|None intervention will be conduct on patient. Only the operating room will be randomized to have an intervention or not (Bundle of measure for optimizing the discipline of personnel in the operating room)
15964071|NCT03158168|Drug|Candida Antigen|Candida Albicans Antigen injection
15964072|NCT03158168|Drug|Zinc Sulfate|Zinc Sulfate injection
15964073|NCT03158142|Drug|Atropine Sulfate 1% Oph Soln|Atropine sulphate 1% ophthalmic solution is both a mydriatic and cycloplegic
15964074|NCT03158129|Drug|Carboplatin|Given IV
15964075|NCT03158129|Drug|Cisplatin|Given IV
15964076|NCT03158129|Drug|Docetaxel|Given IV
15964077|NCT03158129|Biological|Ipilimumab|Given IV
15964078|NCT03158129|Biological|Nivolumab|Given IV
15964079|NCT03158129|Drug|Pemetrexed|Given IV
15964080|NCT03158116|Drug|Inhaled Aztreonam|Inhaled antibiotic with anti-pseudomonal properties
15964081|NCT03158103|Drug|MEK162|MEK162 at 30mg twice daily
15964082|NCT03158103|Drug|Pexidartinib|pexidartinib 600mg daily (400mg in the morning, 200mg at night) for 4 weeks (1 cycle)
15964083|NCT03158090|Procedure|Transnasal butterfly surgery|The patient will be treated in accordance with the advice of the local doctor in charge, and this study does not interfere with any treatment of the patient.
15964084|NCT03158090|Drug|sandostatin|The patient will be treated in accordance with the advice of the local doctor in charge, and this study does not interfere with any treatment of the patient
15964085|NCT03158090|Radiation|radiotherapy|The patient will be treated in accordance with the advice of the local doctor in charge, and this study does not interfere with any treatment of the patient
15964086|NCT03158064|Drug|Durvalumab|1500 mg by IV
15964087|NCT03158064|Drug|Tremelimumab|"75 mg by IV
~*300mg"
15964088|NCT03158051|Behavioral|Home Blood Pressure Monitoring|Intervention arm participants will receive a home blood pressure monitor, home blood pressure log, and training on accurate home monitoring. They will be asked to share their home blood pressure readings during health coach telephone calls.
15964089|NCT03158051|Behavioral|Telephone Health Coaching|Intervention arm participants will receive a health coach phone call every 2 weeks for 6 months, for a total of 12 calls. During each call, the health coach will review and discuss home blood pressures and address barriers and concerns to hypertension management. During each telephone call, the coach will guide the participant on selecting health behavior goals. Intervention arm participants will also receive handouts about hypertension management during the study visits and after health coach calls.
15964090|NCT03158038|Biological|Monovalent Influenza Vaccine|A single dose of monovalent influenza vaccine [10^7.0 +/- 0.5 FFU of each of 1 ca, att, ts 6:2 reassortant influenza strain] will be administered as intranasal spray on Day 1.
15964091|NCT03158038|Other|Placebo|A single dose of placebo matching with monovalent influenza vaccine will be administered as intranasal spray on Day 1.
15964092|NCT03158025|Drug|Zolpidem tablets|Zolpidem 3 x 10 mg tablets will be administered orally.
15964093|NCT03158025|Drug|Suvorexant tablets, over-encapsulated|Suvorexant 2 x 20 mg tablets, over-encapsulated, will be administered orally.
15964094|NCT03158025|Drug|Lemborexant tablets|Lemborexant 1 x 10 mg, 2 x 10 mg, or 3 x 10 mg tablets will be administered orally.
15964095|NCT03158025|Drug|Placebo lemborexant|Placebo 1 x 10 mg, 2 x 10 mg, or 3 x 10 mg lemborexant tablets will be administered orally.
15964096|NCT03158025|Drug|Placebo zolpidem|Placebo 3 x 10 mg zolpidem tablets will be administered orally.
15964097|NCT03158025|Drug|Placebo suvorexant|Placebo 2 x 20 mg suvorexant tablets, over-encapsulated, will be administered orally.
15964098|NCT03158012|Biological|Autologous Microbial Transplant|Twice-daily application of Active or Placebo comparators to the right and left ventral arms of patients
15964099|NCT03157999|Behavioral|Intervention group (CAST)|"Intervention duration is expected to be 6 months. A full-time registered nurse (RN) will function as a Care Transitions Coordinator (CTC) who works collaboratively with one local hospital and other health and non-health representatives to deliver the intervention, which includes:
~care coordination and system navigation (including facilitating timely primary care follow-up);
~medication management;
~assessing the needs and risk of the participants (including in-depth assessment of depressive symptoms);
~evidence-based management of depressive symptoms and other chronic conditions to prevent the onset and worsening of other chronic conditions;
~patient and caregiver education; and goal setting and problem-solving therapy."
15964100|NCT03157986|Other|Balance Training on a vibration platform|n=24 patients with severe chronic obstructive pulmonary disease. Exercises will be performed on a side-alternating Vibration platform (Galileo) at frequencies between 15 to 26 Hertz.
15964101|NCT03157986|Other|Conventional Balance training|n=24 patients with COPD, Exercises will be performed on a Balance pad
15964102|NCT03157973|Other|Education intervention|eHealth tool and standardized nurse-led follow-up.
15964103|NCT03157960|Other|Blueberry drink|Participant receive blueberry drink
15964104|NCT03157960|Other|Blueberry and pizza|Participant receive blueberry drink and a slice of pizza
15964105|NCT03157960|Other|Soft beverage|Participant receive a soft beverage drink
15964106|NCT03157960|Other|Soft beverage and pizza|Participant receive a soft beverage drink and a slice of pizza
15964107|NCT03157960|Other|Fructose|Participant receive a drink containing fructose
15964108|NCT03157960|Other|Fructose and pizza|Participant receive a fructose drink and a slice of pizza
15964109|NCT03157947|Behavioral|Decision Aid Tool|Subjects will be given an I-pad with the decision aid program on it. A member of the study team will enter some preliminary information, then the subject will be able to review the tool with his doctor.
15964110|NCT03157947|Behavioral|baseline survey|patients will be given baseline surveys to gather demographic information and readiness to make a decision regarding prostate cancer care
15964111|NCT03157947|Behavioral|follow-up surveys|at 3, 6, 9, and 12 months patients will be given follow-up surveys regarding prostate cancer care
15964112|NCT03157934|Other|not applicable (observational study)|Observational study without study related intervention
15964113|NCT03157921|Radiation|transvaginal ultrasound|assessment of ovarian volume and antral follicle count
15964114|NCT03157921|Diagnostic Test|Hormonal levels|follicle stimulating hormone level, luteinizing hormone level and anti-mullerian hormone level
15964115|NCT03157908|Device|CareConekta|CareConekta is a smartphone app developed in parallel with a series of focus group discussions that uses global positioning system (GPS) data to identify the user's location to meet two primary functions: (1) to allow the participant to locate ART facilities in South Africa that are near her current location, and (2) to trace mobility prospectively.
15964116|NCT03157895|Behavioral|Connecting|Connecting was adapted for use within the child welfare system from the Staying Connected With Your Teen program that has been demonstrated to prevent substance abuse, risky sexual behavior, and violence during adolescence.
15964117|NCT03157869|Device|Transcranial Direct Current Stimulation|Anodic tDCS during 20 minutes ON, intensity 2milliamps, on the contralateral motor cortex of the trained hand simultaneously with the motor training. The cathode (negative electrode) will be positioned over the contralateral supraorbital region. It wil be used rubber electrodes covered by a vegetal electrode embedded in saline solution, physiological saline, measuring 5 x 5 cm (25 cm2).
15964118|NCT03157869|Other|Simulated|Simulated anodic tDCS (only 30 seconds ON), intensity 2milliamps, on the contralateral motor cortex of the trained hand simultaneously with the motor training. The cathode (negative electrode) will be positioned over the contralateral supraorbital region. It wil be used rubber electrodes covered by a vegetal electrode embedded in saline solution, physiological saline, measuring 5 x 5 cm (25 cm2).
15964119|NCT03157856|Other|Fluorescence assessment|All subjects of the study are going to have a radical prostatectomy. The FEMTO-ST medical device is used on 3 fresh biopsies (2 healthy and 1 malignant) which will be prelevated from the resected prostate in order to determine the prostatic or non-prostatic nature of tissue.
15964120|NCT03157843|Drug|low-molecular-weight heparin|
15964121|NCT03157804|Procedure|IV administration of Genetically Engineered Hematopoietic Stem/Progenitors Cells (HSPCs)|
15964122|NCT03157804|Biological|Genetically Engineered Hematopoietic Stem/Progenitor Cells|Undergo infusion of genetically modified hematopoietic progenitor cell therapy
15964123|NCT03157804|Other|Laboratory Biomarker Analysis|Correlative studies
15964124|NCT03157804|Biological|Filgrastim|Given subcutaneously (SC)
15964125|NCT03157804|Drug|Plerixafor|Given SC
15964127|NCT03157791|Drug|Simethicone 180Mg Cap|Simethicone Group A will take a total of 360mg prior to colonoscopy of Simethicone 180Mg Cap.
15964128|NCT03157778|Other|Obese men|Biological measures before, just before, and after lunch, in obese men
15964129|NCT03157778|Other|Normal-weight men|Biological measures before, just before, and after lunch, in normal-weight men.
15964130|NCT03157765|Procedure|endometrial biopsy|endometrial biopsy
15964131|NCT03157752|Behavioral|Quality of life questionnaire|Quality of life questionnaire
15964132|NCT03157739|Behavioral|MigraineManager: Individualized Self-Management Tool|Answers provided during the online assessment will result in certain intervention recommendations. Once assessments are completed, a treatment plan will be automatically generated for patient and parent guidance.
15964133|NCT03157726|Procedure|Transurethral plasmakinetic enucleation of prostate|Transurethral plasmakinetic enucleation of prostate(PAKEP),an operation mode devised by Liu Chunxiao Team in southern medical university urology department. The theory of the operation is using transurethral resectoscope instead of the finger in the open operation, to find the surgical capsule of prostate and to peel the hyperplastic prostate gland visually in a antidromic way.
15964134|NCT03157726|Procedure|transurethral resection of prostate|"Transurethral resection of prostate(TURP), a kind of mature minimally invasive surgery of prostate , taking the place of the traditional open surgery in 1930s , still is the gold standard operation for surgical treatment of BPH."
15964135|NCT03157713|Behavioral|Goal-Directed Financial Incentives|Patients will receive financial incentives for using a food diary, verified by entries in in the BookFactory Food Diary or another food diary, including internet/app-based diaries ($30 monthly); achieving 75 minutes of physical activity per week in first three months, as verified by a wearable fitness tracker ($20 monthly); achieving 150 minutes of physical activity per week in last three months, as verified by a wearable fitness tracker ($20 monthly); enrollment in a clinic-based or commercial weight loss program ($150 one time); and active participation in clinic-based or commercial weight loss program, as verified by the program ($60 monthly).
15964136|NCT03157713|Behavioral|Enhanced Usual Care|Patients will receive a food diary (BookFactory Food Diary), wearable fitness tracker (Fitbit), exercise and nutrition education materials (American Heart Association's Walking For Better Health and How to Eat Healthy), and referral information for intensive weight loss programs. This information will comprise these commercial and hospital-based weight loss programs that are evidence-based: Weight Watchers and Jenny Craig; the Veterans Administration's MOVE! and TeleMOVE! programs; Bellevue Hospital's Medical Weight Management Clinic and Intensive Nutritional Treatment programs; and New York University Langone Medical Center's Weight Management Program. We will also provide brief instructions on how to use the food diary and Fitbit Charge HR.
15964137|NCT03157713|Behavioral|Outcome-based Financial Incentives|Patients will receive financial incentives for clinically significant weight loss, as confirmed at monthly weigh-ins. At 30 days, they will receive $50 if they lose ≥1.5% to <2.5% of baseline weight or $100 if they lose ≥2.5% of baseline weight. At 2 months and 3 months, they will receive $50 if they lose ≥2.5% to <5% of baseline weight or $100 if they lose ≥5% of baseline weight. At 4, 5, and 6 months, they will receive $100 if they lose ≥2.5% to <5% of baseline weight or $150 if they lose ≥5% of baseline weight. To employ the behavioral economic concept of regret aversion, patients will be given feedback at each assessment point about incentives they would have received had they achieved a loss of at least 2.5% of baseline weight.
15964138|NCT03157700|Behavioral|REAL media curriculum|REAL media is a 5-level, interactive, self-paced, e-learning media literacy curriculum to prevent youth substance use.
15964139|NCT03157674|Other|Non-Interventional|Non-Interventional
15964140|NCT03157648|Other|observing for shivering symptom|In the PACU investigators measure body temperature of all patients at tympanic membrane, forehead, and dorsal of hand. Investigators calculate the difference between body temperature measure at tympanic membrane and forehead/dorsal of hand. Investigators observe the shivering symptom and grading for severity.
15964141|NCT03157635|Drug|Crovalimab|Crovalimab will be administered as per schedule described in individual arm.
15964142|NCT03157635|Drug|Placebo|Placebo will be administered as per schedule described in Part 1 placebo arm.
15964143|NCT03157622|Behavioral|Exposure in vivo|10 sessions based on an individualized fear hierarchy
15964144|NCT03157622|Behavioral|Cognitive Behavioural Psychotherapy|graded activity, relaxation techniques and cognitive interventions
15964145|NCT03157609|Device|Thermometry|Within the same patient comparison of 2 thermometry methods: SpotOn skin sensor versus oesophageal temperature probe
15964146|NCT03157596|Other|Oral Health Educational Program for Caregivers of Children with developmental disabilities|Oral Health Education Program for Caregivers of Children with developmental disabilities included information about health issues and obstacles encountered in children with DD & methods of prevention and management. It also emphasized on proper oral hygiene measures for this group. (University of Washington 2010)
15964147|NCT03157583|Other|NGBUV000A, (Expected SPF 30)|A total of 2.0 ± 0.05 mg/cm2 (milligram per centimeter square of test site area) NGBUV000A (test product 1) will be spread at the topical test sites on the back of each participant. And a total of 1.3 mg/cm2 of test product 1 will be applied to the test plates.
15964148|NCT03157583|Other|NGBUV000B, (Expected SPF 30)|A total of 2.0 ± 0.05 mg/cm2 NGBUV000B (test product 2) will be spread at the topical test sites on the back of each participant. And a total of 1.3 mg/cm2 of test product 2 will be applied to the test plates.
15964149|NCT03157583|Other|NGBUV000C, (Expected SPF 30)|A total of 2.0 ± 0.05 mg/cm2 NGBUV000C (test product 3) will be spread at the topical test sites on the back of each participant. And a total of 1.3 mg/cm2 of test product 3 will be applied to the test plates.
15964150|NCT03157583|Other|NGBUV000D, (Expected SPF 30)|A total of 2.0 ± 0.05 mg/cm2 NGBUV000D (test product 4) will be spread at the topical test sites on the back of each participant. And a total of 1.3 mg/cm2 of test product 4 will be applied to the test plates.
15964151|NCT03157583|Other|P3 Standard, (Expected SPF 16)|A total of 2.0 ± 0.05 mg/cm2 reference P3 standard will be spread at the topical test sites on the back of each participant.
15964152|NCT03157583|Other|Sunscreen formulation S2|A total of 1.3 mg/cm2 of sunscreen formulation S2 will be applied to the test plates.
15964153|NCT03157583|Other|Glycerin|A total of 1.3 mg/cm2 of glycerin will be applied to the test plates.
15964154|NCT03157570|Behavioral|Exercise|7-min High Intensity Interval Training with 12 different exercises (each exercise 30 seconds continuously with 10 seconds rest interval)
15964156|NCT03157544|Behavioral|multimodal non-pharmacological Pain Relief Kit|"Participants will be told: No two people have the same kind of pain and that pain management must be individualized to your pain. Thus, we want you to try the four modes of the non-pharmacological interventions included in the kit individually and in combination in order to determine what works best to relieve your pain
~The Pain Relief kit will also include written instructions and materials for three behavioral techniques directed at maintaining compliance with the non-pharmacological interventions. During the review of the Pain Relief Kit with a member of the research staff participants will be informed about the recommended use of the three behavioral techniques including setting goals, working with a buddy and keeping a graph of your progress. This information will also be included in written form in the Pain Relief Kit."
15964157|NCT03157531|Device|B-Laser™ Atherectomy System|The B-Laser™ is indicated for use for atherectomy of infrainguinal stenoses
15964158|NCT03157518|Dietary Supplement|Seeking Health Probiota Bifido|• This is a proof of concept study to demonstrate that oral probiotic use can modulate the airway microbiome. After informed consent has been obtained, this study will consist of 2 visits over a four week time period. Each visit will include a blood draw (30ml) and a research bronchoscopy/ bronchoalveolar lavage (BAL) (200ml) visit . A urine pregnancy test will be done on all females of childbearing potential prior to the first BAL as well as a CBC, BMP, and blood clotting tests in all participants. Following the first BAL, subjects will be asked to take an over the counter probiotic supplement (Seeking Health Probiota Bifido) nightly which will be provided to the participant by the study coordinator until the 2nd BAL is performed 4 weeks after the first BAL.
15964159|NCT03157505|Drug|Purethal Birch immunotherapy|Purethal birch was administered as perennial therapy: 24 months
15964160|NCT03157505|Other|Placebo and symptomatic treatment|symptomatic treatment including: antihitamine drug, nasal dropps and placebo injection
15964161|NCT03157492|Behavioral|Aural Rehabilitation Group|Participants will complete sessions in their home or office via the internet. Sessions will include listening activities, informational counseling and communication strategies training. Three assessment appointments are required. The goal is to evaluate the benefit of training on performance with a cochlear implant.
15964162|NCT03157492|Behavioral|Cognitive Training Group|The Cognitive Training Group will receive six 90-minute sessions including training exercises (Ken-Ken, Sudoku, Crosswords, Word Search, Spot the Difference) to improve speed and accuracy. Three assessment sessions are also required.
15964163|NCT03157479|Drug|Intravenous anesthetic|Anaesthesia induction will be obtained with i.v. 2-3 mg/kg propofol, 0,6-0,8 mcg/kg fentanyl, and 0.9-1,2 mg/kg rocuronium. Anaesthesia will be maintained with i.v. propofol continuous infusion, with a dose titrated to achieve a bi-spectral index value between 40 and 50
15964164|NCT03157479|Drug|Crystalloid Solutions|Balanced crystalloids will be administered to patients in both groups as a standard rate of 3-5 ml/kg/h. Treatment of eventual hemodynamic instability will be left to the attending physician
15964165|NCT03157479|Diagnostic Test|Esophageal pressure measurement|A nasogastric polyfunctional tube (Nutrivent, Sidam, Italy) will be placed after anaesthesia induction in all enrolled patients to measure esophageal pressure, estimate pleural pressure and compute transpulmonary pressure
15964166|NCT03157479|Diagnostic Test|Lung volume measurement with the nitrogen washin-washout technique|Lung volume will be measured through nitrogen wash-in wash-out technique and low-flow Pressure-volume curve will be recorded to estimate differences in alveolar recruitment between the two study groups.
15964167|NCT03157440|Diagnostic Test|Ring oxymetry|a new type oxymetry wear on index finger like a ring
15964168|NCT03157427|Device|CRYOBEAUTY MAINS|CYOBEAUTY MAINS diffuses Difluoroethane gas to the skin. The administration of the cryogenic gas is temperature controlled, accurate and contactless (by means of a spray nozzle), in small quantity (<1g) and during a predetermined short duration (3 seconds)
15964169|NCT03157414|Drug|Empagliflozin|Empagliflozin tablets enclosed with red capsules (Capsugel AAEL) by Kragerø Tablettproduksjon AS for blinding purpose
15964170|NCT03157414|Other|Placebo|Placebo tablets made by Kragerø Tablettproduksjon AS and enclosed with red capsules (Capsugel AAEL) for blinding purpose
15964171|NCT03157401|Drug|intravenous infusion group|In the tranexamic acid intravenous infusion group (n = 30), 15 mg/kg tranexamic acid diluted in 100 mL physiological saline was intravenously infused at the beginning of the surgery. After suturing deep fascia, 20 mL of physiological saline was intra-articularly injected.
15964172|NCT03157401|Drug|intra-articular injection group|In the tranexamic acid intra-articular injection group (n = 30), 100 mL of physiological saline was intravenously infused at the beginning of the surgery. After suturing deep fascia, the mixture of 1.5 g tranexamic acid and 20 mL physiological saline was intra-articularly injected.
15964173|NCT03157401|Drug|control group|In the control group (n = 30), 100 mL of physiological saline was intravenously infused at the beginning of the surgery. After suturing deep fascia, 20 mL of physiological saline was intra-articularly injected.
15964174|NCT03157388|Drug|Combined Vancomycin and Gentamycin and Meropenem|"The following combined antibiotic regime will be administered for eradication of gut bacteria.
~7 days combined antibiotic treatment, per oral route, once daily: vancomycin 500 mg (Vancomycin Hospira), powder for concentrate and gentamycin 40 mg (Hexamycin®), solution and meropenem 500 mg (Meropenem Hospira), powder for concentrate; The three drugs are dissolved and combined in approximately 100 ml of apple juice."
15964175|NCT03157375|Device|Intraocular Lens Implantation|
15964176|NCT03157362|Other|Near Non-Social|Participants will be stably seated, and observed by a research assistant, as they complete an induced pain threshold task while they experience a virtual environment that reproduces the room in which they are seated.
15964177|NCT03157362|Other|Near Social|Participants will be stably seated, and observed by a research assistant, as they complete an induced pain threshold task while they experience a virtual environment that reproduces the room in which they are seated, and converse with a confederate represented by an avatar.
15964178|NCT03157362|Other|Far Non-Social|Participants will be stably seated, and observed by a research assistant, as they complete an induced pain threshold task while they experience a virtual environment that reproduces a different room.
15964179|NCT03157362|Other|Far Social|Participants will be stably seated, and observed by a research assistant, as they complete an induced pain threshold task while they experience a virtual environment that reproduces another room, and converse with a confederate represented by an avatar.
15964654|NCT03153202|Drug|Pembrolizumab|200mg IV pembrolizumab on Day 1 of each cycle
15964180|NCT03157349|Other|Biofreeze|Biofreeze is a topical analgesic that uses the cooling effect of menthol, a natural pain reliever, to soothe minor muscle and joint pain. The product will be applied 10 minutes prior to manipulation and at home for 4 times a day for 1 week
15964181|NCT03157349|Other|Placebo|The placebo is the Biofreeze product with all active ingredients removed. The product will be applied 10 minutes prior to manipulation and at home for 4 times a day for 1 week
15964182|NCT03157336|Other|Non Inferiority WTM Interventional Trial|The intervention will implement the WTM cassava processing technique in participating households. Twenty women (in leading roles) will be our principal candidates to serve as peer trainers. Together with a 20 community health worker specialists, these women will be trained in the WTM technique by the Kinshasa team of community health workers who are experts in the WTM method. Those who master the technique will then be certified as trainers to train and support other small groups of other mothers throughout a two-year period in the implementation of the WTM for the safer processing of food for their families. Both the community health worker specialists and trained women (prospective trainers) would have to be able to bring the cassava cyanogenic content to the lowest achievable level, which must be < 10 ppm as per the recommendations of the World Health Organization.
15964183|NCT03157323|Behavioral|Low Glycemic Index Diet|The nutritional intervention is theory-based and will provide nutritional education and counseling to children and their families. Nutritional counseling will be provided by the institutional designate and will focus on increasing patients' understanding of the benefits of a low GI diet, increase knowledge of low GI diet, overcoming barriers, and establishing expectations of the diet.
15964184|NCT03157310|Drug|Gefitinib|Daily oral administration of 250 mg Gefitinib
15964185|NCT03157297|Device|MARVEL algorithm|Software download into implanted Micra device
15964186|NCT03157284|Dietary Supplement|Rice Flour|For 12 weeks, a group of children will receive 7gr fermented rice flour according to a randomised, double-blind design.
15964187|NCT03157284|Dietary Supplement|Placebo|For 12 weeks a group of children will receive a 7gr of a placebo (maltodextrin), according to a randomised, double-blind design.
15964188|NCT03157271|Other|Intramuscular Dry Needling|Dry Needling is a procedure in which a solid filament needle is inserted into the skin and muscle directly at a myofascial trigger point. A myofascial trigger point consists of multiple contraction knots, which are related to the production and maintenance of the pain cycle and interfere with movement patterns.
15964189|NCT03157258|Behavioral|Social Network Training|Members of HIV+ social networks randomized to this arm will be trained to endorse compliance with medical guidelines and adherence to medical treatment regimens to their friends.
15964190|NCT03157258|Behavioral|Single Care-Related Counseling Session and Referral to Care|Members of HIV+ social networks randomized to this arm will attend a single, brief care-related counseling session and referral to care at baseline.
15964191|NCT03157245|Diagnostic Test|DOPPLER ULTRASOUND|MESURE OF THE PRESENCE OR NOT OF A CATHETER RELATED VEIN THROMBOSIS
15964192|NCT03157232|Device|Rainbow DCI and R1-25 sensor|Noninvasive Measurement of SpHb
15964193|NCT03157193|Drug|Hyaluronic Acid|Hyaluronic acid gel application as coadjuvant in the treatment of perimplantitis.
15964194|NCT03157193|Drug|Hydroxypropyl Guar|Hydroxypropyl Guar gel application as sham comparator
15964195|NCT03157167|Drug|Tc99m-tilmanocept|Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
15964196|NCT03157154|Other|Non interventional study|A query form to all concerned patients by each investigating centre will be send
15964197|NCT03157141|Procedure|Ankle arthrodesis|Ankle arthrodesis consists of fusioning the joint surfaces of the ankle. The procedure will consist of removing the diseased cartilage and subchondral bone until bleeding of the cancellous bone surfaces is revealed. The bone ends will be opposed in the most appropriate and stable position and stabilized with screws or plates.
15964198|NCT03157141|Procedure|Total ankle replacement|A two-component ankle prosthesis will be inserted using the surgeon's standard technique, which essentially involves an anterior approach to the ankle joint. Once the joint is exposed, talar and tibial surfaces will be prepared and the prosthesis will be implanted according to the prosthesis surgical technique and its instrumentation.
15964200|NCT03157115|Device|Kinocardiography|"This device records the electric and mechanic function of the heart. With electrodes and adequate electronics, ECG is recorded. 6 degrees of freedom accelerometers are also included in the device to measure the micro accelerations of the body at the body surface when the device is placed on the skin. Using physics principles and adequate calibration, those accelerations allow us to calculate parameters such as kinetics energies related to heart contractility.
~During a standard appointment for a patient suffering from a cardiac condition with/without heart failure, the cardiologist will monitor the heart of the patient with the Kino device (examination lasting a few minutes with the patient lying down on a bed). Data will be matched between the control group and the experimental group."
15964201|NCT03157102|Device|HFNC|"Oxygen therapy will be delivered through high flow nasal cannulas. Aerosol treatments will be administered through a vibrating mesh nebulizer directly connected to the circuit (aerogen®). The airvo® system (Fisher & Peykel Healthcare, Auckland, New Zealand) will be used as the high flow cannula system in the study. Cannula size will be tailored to the child according to the manufacturer's recommendations. The gas flow will be adjusted according to the child's weight in a predefined chart. FiO2 will be adjusted to allow for a SpO2 >92%.
~All the patients, regardless of their treatment failure status, will be evaluated at H2, H6, H12 and H24 to monitor their evolution (evaluation of the standard parameters, consciousness, PRAM (Pediatric Respiratory Assessment Measure) score, pain assessment by the FLACC (Face Legs Activity Cry Consolability) score). ."
15964202|NCT03157102|Device|Standard Oxygen Treatment|"Children will receive supplemental oxygen as commonly delivered through a non-rebreather face mask or low flow nasal cannula (standard oxygen treatment) and beta2 agonist aerosol via vibrating mesh nebulizer (aerogen®) according to the procedures usually used in the unit and according to the GINA (Global Initiative for Asthma) protocol. This group is the standard treatment group and is therefore the control group.
~All the patients, regardless of their treatment failure status, will be evaluated at H2, H6, H12 and H24 to monitor their evolution (evaluation of the standard parameters, consciousness, PRAM score, pain assessment by the FLACC score). The use of adjuvant therapies (magnesium sulfate, salbutamol IVSE, and ipratropium bromide) will remain at the discretion of the physician in charge of the child and will be evaluated as a secondary criterion."
15964205|NCT03157076|Device|Cardiac Resynchronization therapy device with Closed Loop Stimulation (CLS)|The feature CLS will be programmed ON or Off according to a randomization list after one month after baseline visit. One month later the alternate will be programmed.
15964206|NCT03157063|Diagnostic Test|Data Collection Procedures|"Orientation (Consent, Screening Questionnaires) Clinic Measurements Body composition, via dual energy X-ray absorptiometry (DXA) Resting metabolic rate (RMR), via indirect calorimetry; Metabolic responses to a meal, via thermic effect of feeding (TEF) Subjective aspects of eating behavior using the Three Factor Eating Questionnaire (TFEQ) and Control of Eating Questionnaire (CEQ) Appetite, via visual analogue scales (VAS) pre- and post a prepared fixed meal and hormones related to satiety and hunger (insulin, leptin, ghrelin, peptide YY, glucagon-like peptide-1) obtained during blood samples (BLOOD) from an indwelling catheter.
~Home assessments - Data collected at home during a 14 day window Fitness Test (VO2submax and VO2max) and DXA functional magnetic resonance imaging (fMRI)"
15964207|NCT03157050|Other|Intravenous iron therapy|each patient with iron def anemia received an IV syringe of iron sucrose 100 mg every dialysis session for 10 doses
15964208|NCT03157037|Biological|HMed-IdeS|One dose of 0.25 mg/kg BW HMed-IdeS on study day 1
15964209|NCT03157024|Device|Ring Sham (RS)|
15964210|NCT03157024|Device|Real Needle (RN)|
15964211|NCT03157024|Device|Kim Sham (KS)|
15964212|NCT03157011|Other|Global symptom score (GSS) questionary|systematic research of digestive symptoms in patients with SGSp with Global symptom score (GSS) questionary, which allowed to grades severity of 10 digestive symptoms (absent, mild, moderate, or severe), asthenia and fever.
15964213|NCT03156972|Procedure|Replacment of mitral valve|Mitral valve replacment by prothsis
15964214|NCT03156959|Behavioral|EMDR|The Eye Movement Desensitization and Reprocessing (EMDR) is a psychotherapy developed by Francine Shapiro (2001) that emphasizes disturbing memories as the cause of psychopathology. These memories and associated stimuli are inadequately processed and stored in an isolated memory network (Shapiro and Laliotis, 2010). The goal of EMDR is to reduce the long-lasting effects of distressing memories by developing more adaptive coping mechanisms.
15964215|NCT03156959|Behavioral|CBT-Eb|"The broad form of Enhanced Cognitive Behavioural Therapy (CBT-Eb; Fairburn and colleagues, 2009) addresses psychopathological processes external to the eating disorder, such as clinical perfectionism, low self-esteem or interpersonal difficulties, which interact with the disorder itself."
15964216|NCT03156946|Behavioral|breastfeeding mother-to-mother support|The mother-infant dyads in the intervention arm will receive breastfeeding mother-to-mother support from the hospitalization in the maternity and NICU up to 1 month after discharge. The intervention will be in addition to the usual or routine care. Breastfeeding counselors will be voluntary mothers who breastfed their own preterm infant (aged between 6 months and 5 years at the time of the study) for a minimum of 2 months, and who have had a positive personal breastfeeding experience, and who have undertaken a training course.
15964217|NCT03156946|Behavioral|Control|The mother-infant dyads in the control arm will continue to receive the usual/routine care provided by participating centers during the hospitalization and Mother and Infant Protection service after discharge.
15964218|NCT03156933|Other|Assessment of splicing variants|This is a biological study with primary samples without any intervention on patients.
15964219|NCT03156920|Drug|Placebo|Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
15964220|NCT03156920|Drug|Sumatriptan|Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
15964221|NCT03156907|Drug|Buprenorphine|HDB is started (J0) at the dosage of 4 mg/ day (with a possible adjustment ± 2 mg at 24h, depending on the patient withdrawal symptoms intensity or tolerance).
15964222|NCT03156881|Other|Global Osteopathic Treatment|"The study objectives is to observe a difference and improvement of liver function based on liver enzyme count from blood work after osteopathic treatments. Also to observe an improvement in the patients quality of life after receiving treatment and in their readiness to change.
~Osteopathy is a type of manual therapy that uses gentle manipulations taking into consideration of the whole person when treating. For example if the liver is being treated, osteopaths look for mobility, to carry out its proper function. However one will also assess its interrelationships that can influence the liver such as its neighbours, articulating structures, example the diaphragm as well as its neurological input from T5-T9 for instance."
15964223|NCT03156855|Drug|14-day sequential therapy|D1-D7: (esomeprazole 40mg qid + amoxicillin 500mg qid) for 7 days D8-D14: (esomeprazole 40mg qid + clarithromycin 500mg bid + metronidazole 500mg bid) for another 7 days
15964224|NCT03156855|Drug|Bismuth quadruple therapy|D1-D10: (esomeprazole 40mg bid + dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days
15964225|NCT03156842|Drug|Fimasartan/Amlodipine, Rosuvastatin|"A fixed dose combination tablet of Fimasartan and Amlodipine and Rosuvastatin will be administrated once daily on treatment period."
15964226|NCT03156842|Drug|Fimasartan/Amlodipine|"A fixed dose combination tablet of Fimasartan and Amlodipine will be administrated once daily on treatment period."
15964227|NCT03156842|Drug|Fimasartan, Rosuvastatin|"Fimasartan and Rosuvastatin will be administrated once daily on treatment period."
15964228|NCT03156829|Other|Splint|Custom made splint
15964229|NCT03156829|Drug|Betamethasone|Corticosteroid Injection Brand name of the drug: Celestone Soluspan Dosage: 6 mg/ml
15964230|NCT03156829|Combination Product|Splint + Cortico-steroid injection|Splint + Cortico-steroid injection given in combination
15964231|NCT03156816|Drug|Colchicine group (experimental arm)|In the experimental group, patients will receive colchicine, starting with a loading dose of 2 mg at the time of revascularization and continuing with 0.5 mg twice daily (b.i.d) for 5 days.
15964232|NCT03156816|Drug|Placebo group (control arm)|In the placebo group, patients will receive placebo, starting with a loading dose of 2 mg at the time of revascularization and continuing with 0.5 mg twice daily for 5 days.
15964233|NCT03156803|Behavioral|Healthy eating blog|For a 6-month period, mothers randomised to the HEB group will receive a weekly blog post discussing various positive aspects of healthy eating and presenting recipes and strategies to increase dairy product intakes and vegetable and fruit intakes. The posts will be developed with an emphasis of food skills acquisition.
15964265|NCT03156478|Behavioral|Digital lifestyle intervention group|Intervention with digital application for lifestyle changes
15964234|NCT03156790|Drug|Spectrila®|3 intravenous doses of 10 000 U/m² BSA each during induction phase I of the underlying BRALL 2014 treatment protocol on Days 21, 23 and 25. Additionally, the subjects (standard risk subjects only) will receive doses of 10 000 U/m² BSA each on Days 2, 4, 6, 9, 11 and 13 of the consolidation phase II, III and VI of BRALL 2014 treatment protocol.
15964235|NCT03156764|Other|Qp/Qs ratio monitoring|Op/Qs -monitor will be calculated using SpO2 and cerebral oximetry Op/Qs -blood will be calculated using ABGA and VBGA
15964236|NCT03156751|Diagnostic Test|Feasibility of introducing onsite test for syphilis in the package of antenatal care at rural primary health care in Burkina Faso|This study used a pre post intervention mixed methods quasi-experimental design with a group of health facilities offering ANC services. It was conducted in three phases, which consisted of a situational analysis using qualitative methods (Phase 1), selecting an appropriate test through evaluating 4 candidate tests and the participatory design and implementation of an intervention(Phase 2), and an evaluation combining review of record tools, interviews, time motion study and estimating incremental costs (Phase 3). The conceptual framework draws on multilevel assessment (MLA), policy triangle framework, MRC framework for designing complex interventions and the Normalization Process Model (NPM). The findings suggested that an intervention that introduces point of care test for syphilis at antenatal care services is feasible, acceptable, and of comparable costs to HIV screening in pregnancy. Nonetheless, barriers identified by health workers need to be overcome.
15964237|NCT03156738|Drug|MT-2990|Subjects will receive a single IV dose of MT-2990
15964238|NCT03156738|Drug|Placebo|Subjects will receive a single IV dose of placebo
15964239|NCT03156725|Drug|Ferrous Sulfate|
15964240|NCT03156725|Dietary Supplement|Aspiron|
15964241|NCT03156712|Dietary Supplement|Ferrous sulfate|The intervention is the ASP, a natural form of iron supplement and compared to a widely used dietary iron supplement ferrous sulfate in terms of serum iron response over a 4h period.
15964242|NCT03156686|Procedure|HOME-based hospitalization|patients in Home care treatment (HC) group will be treated at home
15964243|NCT03156673|Biological|bronchial basal cells|Patients will receive of clinical grade bronchial basal cells (BBCs) with a dosage of 10^6 (1 million) cells/Kg/person via fiberoptic bronchoscopy after fully lavage of the localized lesions.
15964244|NCT03156660|Behavioral|Weight gain prevention (Group 1)|"Participants will be asked to keep their weight stable during the initial 8 weeks of the study.
~Intervention Components:
~Lesson materials adapted from the Small Changes intervention, which will provide guidance for meeting the goals of this intervention (i.e., increasing steps by 2000 steps per day, making one Small dietary Change each day).
~Daily self-monitoring of steps and number of Small Changes
~Daily weight self-monitoring on the BodyTraceTM e-scale
~Fit Bit Alta activity trackers to self-monitor steps"
15964245|NCT03156660|Behavioral|Weight loss intervention (Group 2)|"Participants will be asked to achieve a weight loss goal of at least 5% of their baseline weight by week 8.
~Intervention Components:
~Tailored calorie and fat goals based on their baseline weight.
~Daily dietary intake and physical activity self-monitoring using a website or app.
~Daily weight self-monitoring on the BodyTraceTM e-scale
~Lesson materials for each session, drawn from the Look AHEAD intensive lifestyle intervention
~Meal replacements for two meals and one snack for 8 weeks as a method to achieve the study's calorie and fat goals and as a strategy to control portions
~Graded physical activity goals of 175 minutes of moderate intensity exercise (e.g., brisk walking) per week, or 10,000 steps per day
~Fit Bit Alta activity trackers to self-monitor steps"
15964246|NCT03156660|Behavioral|Self-guided intervention (Group 3)|"Participants randomized to Group 3 will wait for 8 weeks before initiating the same smoking cessation intervention as the other two conditions, while they review the provided weight management focused book.
~Intervention Components:
~EatingWell Diet book.
~Daily weight self-monitoring on the BodyTraceTM e-scale"
15964247|NCT03156647|Diagnostic Test|Level of alpha-synuclein|Test of levels of total and ratio total:oligomeric in saliva
15964248|NCT03156634|Other|PALS|PALS is a web based patient education system that uses text and audiovisual formats to deliver patient education materials.
15964249|NCT03156634|Other|WebMD|WebMD is an internet based health information source.
15964250|NCT03156621|Drug|Alirocumab|Alirocumab SC Q2W
15964251|NCT03156621|Drug|Placebo|Matching placebo SC Q2W
15964252|NCT03156608|Device|Novii ECG/EKG System|External fetal heart rate monitoring
15964253|NCT03156608|Device|External fetal heart rate monitoring|External fetal heart rate monitoring
15964256|NCT03156582|Other|Data collecting|
15964257|NCT03156569|Diagnostic Test|Analysis of the saliva|IFN-, IL-10, IL-1b, IL-4 and IL-6
15964258|NCT03156556|Behavioral|Mood Mechanic Course|French-Canadian version of the Mood Mechanic Course. Performed by a professional translator (Bourret Translation Inc.) and reviewed by the research supervisor, Professor France Talbot, clinical psychologist as well with expertise in CBT.
15964259|NCT03156543|Device|Jumpstart Dressing|"JumpStart™ is a wireless, advanced microcurrent generating, dressing used for the management of surgical incision sites. Microcell batteries made of silver and zinc, generate an electrical current when activated by conductive fluids, such as saline, hydrogel or wound exudate. These microcells create low voltage electrical fields to stimulate the surrounding area and to provide antimicrobial protection to assist with wound healing. JumpStart has demonstrated superior broad spectrum bactericidal activity of a wound dressing against antibiotic-resistant strains of wound isolates within 24 hours.
~It will be applied pre-op in all patients and post operatively in group B"
15964260|NCT03156543|Other|Standard Dressing|This is a standard of care bandage that will be placed on participants in group A post operatively
15964261|NCT03156530|Device|Auricular acupunture|Evaluation of balance before, during and after applying of auricular acupuncture.
15964262|NCT03156530|Other|Control|Not receive stimulation.
15964263|NCT03156517|Device|Deep Brain Stimulation|
15964264|NCT03156504|Drug|Ketamine Hydrochloride|Subjects will receive three IV ketamine infusions at 0.5 mg/kg, infused over 100 minutes.
15964777|NCT03152188|Other|Placebo|Fifteen placebo capsules administered at the same time
15964266|NCT03156478|Behavioral|Combined digital and face-to-face lifestyle intervention group|Intervention with digital application and group meetings for lifestyle changes
15964267|NCT03156465|Device|Hybrid L24|Fifteen infants will receive one Nucleus L24 array and a FDA approved standard-length array on contralateral ears.
15964268|NCT03156452|Drug|Mycophenolate Mofetil|500 mg and 250mg tablets for oral administration
15964269|NCT03156452|Drug|Prednisolone|5mg tablets for oral administration
15964270|NCT03156439|Drug|BIS-001 ER|BIS-001 ER is an extended release formulation of the nutritional supplement Huperzine A.
15964271|NCT03156426|Other|Event of interest: Acute kidney injury|AKI as defined by AKIN staging
15964272|NCT03156413|Device|F&P nasal mask|Investigative Nasal Mask to be used for OSA therapy
15964273|NCT03156400|Other|Exercise Stress Test|Gradual increase in treadmill grade while collecting respiratory gases.
15964274|NCT03156387|Procedure|Diode laser|2.8 W diode laser surgery were applied on high frenulum attachment and follow-up VAS scores were evaluated
15964275|NCT03156387|Procedure|Scalpel|Scalpel surgery were performed after local anesthetic administration and VAS scores were recorded.
15964276|NCT03156374|Device|Test use|Use of home ovulation test to predict ovulation
15964277|NCT03156361|Drug|HDV insulin lispro 100 UNIT/mL|Hepatic Directed Vesicle (HDV) added to commercial insulin lispro
15964278|NCT03156361|Drug|Insulin Lispro 100 Units/mL|Sterile Water for Injection added to commercial insulin lispro
15964279|NCT03156348|Other|Clinical Pharmacist Care|"During hospitalization and at discharge a clinical pharmacist (CP) will monitor daily pharmacological safety and efficacy of the medication to asses and make appropriate recommendations. CP will explain the use reasons of each of the drugs.
~At 30 days post-discharge, the CP will review the updated clinical record of patient and conduct a home visit to enhance and ask about adherence, self-medication, medication use at that time and possible results of laboratory tests performed and clarify doubts regarding the use of current medications. The same activities will be made at 60 days by telephonic way, to reinforce the recommendations."
15964280|NCT03156335|Device|Focused Ultrasound|MR-guided Focused Ultrasound (MRgFUS) offers the possibility of lesioning deep brain targets, while obviating the need for open surgical approaches. There is no radiation, incision, or burr hole, and lesions are generated in real-time under MR image guidance. Intracranial FUS for other applications, essential tremor most notably, has been shown to be safe and effective, recently receiving Health Canada approval for this indication. The technology, methods and procedures used in this study are identical to those in essential tremor.
15964281|NCT03156322|Drug|5 mL epidural initiation volume (bupivacaine + fentanyl)|5 mL 0.625% bupivacaine + 2 μg/mL fentanyl solution is administered from epidural catheter
15964282|NCT03156322|Drug|10 mL epidural initiation volume (bupivacaine + fentanyl)|10 mL 0.625% bupivacaine + 2 μg/mL fentanyl solution is administered from epidural catheter
15964283|NCT03156322|Drug|20 mL epidural initiation volume (bupivacaine + fentanyl)|20 mL 0.625% bupivacaine + + 2 μg/mL fentanyl solution is administered from epidural catheter
15964284|NCT03156296|Drug|Dexmedetomidine|patients will receive ultrasound guided TAP block using 0.3 ml/kg bupivacaine (0.125%) with a maximum volume of 20 ml + 0.25 mg/kg dexmedetomidine dissolved in 2 ml normal saline (0.9%)
15964285|NCT03156296|Drug|Bupivacaine|patients will receive ultrasound guided TAP block using 0.3 ml/kg bupivacaine (0.125%) with a maximum volume of 20 ml + 2 ml normal saline (0.9%)
15964286|NCT03156283|Behavioral|SleepWell24 Application|An evidence-based behavioral change smartphone application designed to promote adherence to positive airway pressure (PAP) therapy
15964287|NCT03156283|Other|Usual Care Plus Activity Monitor|Participants will receive usual care at the Mayo Clinic Center for Sleep Medicine when first diagnosed with sleep apnea and prescribed positive airway pressure therapy. In addition, they will receive a commercial activity monitor with an associated smartphone application to isolate the effect of SleepWell24 on PAP adherence from potential novelty effects due to receiving a generic health behavior change app.
15964288|NCT03156270|Device|Vivaer Stylus|Stylus used to deliver low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area
15964289|NCT03156257|Biological|Blood volume collected specifically for this study|The subject will be sitting in a chair, and a needle will be inserted into a vein in their arm. Study Team will draw about 45ml or 3 tablespoons of whole blood for research.
15964290|NCT03156231|Drug|ACETAZOLAMIDE oral capsule|Administration of 125mg acetazolamide in the morning, 250mg in the evening, starting 24 hours before departure to 3200m
15964291|NCT03156231|Drug|Placebo oral capsule|Administration of equally looking placebo capsules in the morning and evening, starting 24 hours before departure to 3200m
15964292|NCT03156218|Drug|Modulation of FiO2|Modulation of FiO2: FiO2 will be reduced to 21% or until peripheral oxygen saturation of 92%, whatever occurs first. Subsequently FiO2 will be increased up to 100%.
15964293|NCT03156205|Behavioral|interactive music therapy|For the interactive music therapy intervention group, each patient received individual interactive music therapy sessions administered by professional music therapists during daytime; the patient participated in listening to music predetermined based on his/her preference during night time.
15964294|NCT03156205|Behavioral|passive music listening|For the passive music listening group, each patient participated in music listening during night time without involving in interactive music therapy sessions during daytime.
15964295|NCT03156205|Behavioral|passive earphone-use|For the passive earphone use group (control group), each participant used headphone and eye mask without music listening at night time.
15964296|NCT03156192|Behavioral|Survey|Survey on the level of depression, quality of life, current and past music experiences, and perceived benefits of music in relation to psycho-social needs
15964331|NCT03155893|Drug|AL-335 Placebo (matching 1200 mg AL-335)|Participants will receive a single dose of AL-335 placebo (matching 1200 mg AL-335 [3*400 mg tablets]) administered orally on Day 15 in Treatment A and B.
15964332|NCT03155893|Drug|Moxifloxacin Placebo (matching 400 mg moxifloxacin)|Participants will receive a single dose of moxifloxacin placebo (matching 400 mg moxifloxacin [1*400 mg capsule]) administered orally on Day 1, 15 and 16 in Treatment A, on Day 1, 2 and 15 in Treatment B and on Day 1, 2, 15 and 16 in Treatment C.
15964333|NCT03155893|Drug|ODV 25 mg|Participants will receive ODV 25 mg orally once daily administered on Days 2 to 16 in Treatment C.
15964297|NCT03156179|Diagnostic Test|calcium isotope analysis|A dual stable calcium isotope method will be used to determine fractional calcium absorption. Two stable calcium isotopes will be administered to participants in order to determine fractional calcium absorption. 7 mg of 44Ca will be administered orally in 60 mL of liquid at the start of the study. 2 mg of 42Ca will then be administered intravenously. 24 hour urine collection will begin immediately following oral tracer administration for the assessment of urinary calcium excretion. The enrichment of 44Ca and 42Ca in urine will be determined by magnetic sector thermal ionization mass spectrometry. The isotopic ratios of 44Ca and 42Ca to 48Ca (another naturally occurring calcium isotope present in the human body) will be calculated (42Ca/48Ca and 44Ca/48Ca). The relative fraction of the oral to intravenously administered isotope in the 24 hour urine sample [(42Ca/48Ca) / (44Ca/48Ca)] is the fractional calcium absorption.
15964298|NCT03156166|Procedure|fiberoptic bronchoscope|Distance from grille (the end of shaft in supraglottic airway) to glottis is measured using FOB
15964299|NCT03156153|Drug|Bumetanide|bumetanide tablets, oral intake, 0.5mg, twice daily, respectively at 8 am and 4 pm
15964300|NCT03156153|Drug|Placebo|placebo tablets, oral intake, 0.5mg, twice daily, respectively at 8 am and 4 pm
15964301|NCT03156140|Other|Motion|Volunteer has motion on right hand while with continuous pulse oximetry during three oxygenation plateaus
15964302|NCT03156127|Drug|BR-UPS 5 mg tablet, Inisia 5 mg tablet|Subjects of Control group will be first orally administered with inisia 5mg tablet . After washout period of 2 weeks, They will be orally administered with BR-UPS 5mg tablet. On the contrary, Subjects of Test group will be first orally administered with BR-UPS 5mg tablet. After washout period of 2 weeks, They will be orally administered with inisia 5mg tablet.
15964305|NCT03156101|Biological|BinD19|Autologous T cells purified from the peripheral blood mononuclear cells of subjects, transduced with TCR-ζ/4-1BB lentiviral vector, expanded in vitro and then frozen for future administration.
15964306|NCT03156088|Device|"Sacral Neuromodulator InterStim"|
15964307|NCT03156075|Behavioral|Nutrition and exercise program|"Nutrition education will be about increasing the intake calcium and vitamin D rich foods and exposure to sun will provided for the intervention group.
~Education of the patients about exercises that increases the strength of lower limb and hip muscles to increase the mobility of the patients earlier and decrease the mortality in turn."
15964308|NCT03156062|Drug|Topical corticosteroids with salicylic acid|comparison between climatotherapy and topical combination of corticosteroids and salicylic acid in treatment of psoriasis
15964309|NCT03156049|Procedure|Sphenopalatine block|patients will receive bilateral sphenopalatine ganglion block using 3ml mixture of 2ml 2% lidocaine plus 1ml dexamethasone 4mg (on each nostril).
15964310|NCT03156049|Procedure|Greater occipital nerve block|patients will receive bilateral greater occipital nerve block using a mixture of 3ml of 2ml 2% lidocaine plus 1ml dexamethasone 4mg (on each side of the occipital region).
15964311|NCT03156036|Drug|Capecitabine plus temozolomide VS Capecitabine|"For each cohort of MGMT hypermethylated versus MGMT unmethylated, patients will be randomised (ratio 1:1 for each arm) into preoperative CRT with capecitabine or preoperative CRT with temozolomide plus capecitabine arms.
~Chemotherapy during preoperative chemoradiotherapy:
~Capecitabine and temozolomide will be administered during radiotherapy with drug holidays (weekend break).
~dosage: Capecitabine 825 mg/m2 twice daily, Temozolomide 75 mg/m2/day"
15964312|NCT03156023|Drug|AMG 570|Investigational product solution in vial
15964313|NCT03156023|Drug|Placebo|Placebo investigational product in vial
15964314|NCT03156010|Device|Neuro Kinetics IPAS|Testing with PAS device
15964315|NCT03156010|Device|Oculogica EyeBox|Testing with Oculogica EyeBox device
15964316|NCT03156010|Device|SyncThink EyeSync Device|Testing with SyncThink EyeSync device
15964317|NCT03155997|Drug|Abemaciclib|Administered orally.
15964318|NCT03155997|Drug|Standard Adjuvant Endocrine Therapy|Administered according to label instructions.
15964319|NCT03155984|Drug|Anti-CD20 antibody|All patients receiving anti-CD20 therapy (rituximab, ofanumumab, obinutuzumab) for hematological malignancies
15964320|NCT03155971|Device|Paclitaxel-Coated Balloon|SeQuent ® Please; B.Braun, Melsungen, Germany
15964321|NCT03155945|Drug|APD371|APD371 active treatment for 8 weeks.
15964322|NCT03155932|Drug|APD334|APD334 active treatment for 24 weeks.
15964323|NCT03155919|Dietary Supplement|TAUchoc|The supplements were offered during eight weeks in capsules containing three grams of taurine powder and 400 ml of chocolate milk ready to drink.
15964324|NCT03155919|Dietary Supplement|PLAchoc|The supplements were offered during eight weeks in capsules containing three grams of placebo (starch powder) and 400 ml of chocolate milk ready to drink.
15964325|NCT03155906|Other|Health care delivery|Integrated HCV treatment within the OST clinics will compared to standard treatment. Those who are eligible to receiving treatment in line with national guidelines, have no exclusion criteria and consent to study participation, will be randomised to either standard or integrated treatment. For the integrated treatment, treatment initiation, follow-up and delivery of medication will be given at a MAR outpatient clinic where they already receive care including OST. Those randomised to standard treatment will be referred to a medical ward clinic for assessment of treatment initiation and follow-up. Assessment of outcomes will be done 12 weeks after completed treatment and adherence will be assessed at 4, 8 and 12 weeks after initiation of treatment.
15964326|NCT03155893|Drug|ODV Placebo (Matching 25 mg ODV)|Participants will receive ODV placebo (matching 25 [mg] ODV [1*25 mg tablet]) once daily in Treatment A and B from Day 1 to 16 and Treatment C on Day 1.
15964327|NCT03155893|Drug|ODV Placebo (Matching 200 mg ODV)|Participants will receive ODV placebo (matching 200 mg ODV [4*50 mg tablets]) on Days 1 and 2 in Treatment E.
15964328|NCT03155893|Drug|ODV Placebo (Matching 125 mg ODV)|Participants will receive ODV placebo (matching 125 mg ODV [2*50 mg tablets + 1*25 mg tablets]) orally once daily on Days 3 to 7 in Treatment E.
15964329|NCT03155893|Drug|ODV Placebo (Matching 100 mg ODV)|Participants will receive ODV placebo (matching 100 mg ODV [2*50 mg tablets] orally once daily on Days 8 to 14 in Treatment E.
15964330|NCT03155893|Drug|SMV Placebo (Matching 150 mg SMV)|Participants will receive SMV Placebo (matching 150 mg SMV [2*75 mg capsules]) orally once daily administered from Day 1 to 16 in Treatment A, B and on Day 1 in Treatment C.
15964334|NCT03155893|Drug|ODV 200 mg|Participants will receive ODV 200 mg (4*50 mg tablets) orally once daily will be administered on Days 1 and 2 in Treatment F.
15964335|NCT03155893|Drug|ODV 125 mg|Participants will receive ODV 125 mg (2*50 mg tablets + 1*25 mg tablets) once daily administered on Days 3 to 7 in Treatment F.
15964336|NCT03155893|Drug|ODV 100 mg|Participants will receive ODV 100 mg (2*50 mg tablets) orally once daily administered on Days 8 to 14 in Treatment F.
15964337|NCT03155893|Drug|SMV 150 mg|Participants will receive SMV 150 mg (2*75 mg capsules) orally once daily administered on Days 2 to 16 in Treatment C.
15964338|NCT03155893|Drug|AL-335 1200 mg|Participants will receive a single oral dose of AL-335 1200 mg (3*400 mg tablets) administered on Day 15 in Treatment C.
15964339|NCT03155867|Other|Meal replacement|The study interventions contain protein, carbohydrate and fat and are intended for use as complete meal replacements for weight loss.
15964340|NCT03155854|Procedure|Pretendinous cord excision|The cord/palmar fascia will be excised during surgery.
15964341|NCT03155854|Procedure|Division/manipulation of the cord|The pretendinous cord will be divided and incised during surgery.
15964342|NCT03155841|Behavioral|Life Skills Coaching|The investigators designed the intervention to help participants increase their HIV risk awareness, promote self-appraisal and increase motivation for engaging in prevention services, problem solving barriers to accessing care, and locating culturally-sensitive providers. Intervention content is customized based on participants' socio-demographic characteristics and geographic location.
15964343|NCT03155841|Behavioral|Community Resources|The investigators will provide a resource locator as the attention-control condition. The resource locator provides a list of health (e.g., HIV testing) and social (e.g., support groups) resources across study regions.
15964344|NCT03155828|Device|CPAP|Women with diagnosed obstructive sleep apnea will be treated using continuous positive airway pressure as per standard of care.
15964345|NCT03155789|Procedure|Lumbar Fusion|"Standard Transforaminal Lumbar Interbody Fusion (S TLIF)
~Minimally Invasive Transforaminal Lumbar Interbody Fusion (MI TLIF)
~AxiaLIF Fusion"
15964346|NCT03155776|Diagnostic Test|GUS|gastric volume estimation using gastric ultrasound was performed immediately after anesthetic induction, and after aspirating the residual gastric contents using nasogastric tube
15964347|NCT03155763|Procedure|Intraoperative kidney allograft preimplantation biopsy; Intraoperative kidney allograft postreperfusion biopsy|
15964348|NCT03155750|Other|Zero Time Exercise|Zero Time Exercise encourage people to increase physical exercise by simple movements that can be done any time at any places. We offer a 2-session training course to train the subjects to do zero-time exercise.
15964349|NCT03155750|Other|Sleep hygiene education|We offer a 2-session education course to teach the subjects about sleep hygiene practice.
15964350|NCT03155737|Other|Self-acupressure|A training course will be offered to subjects in this group to train them to perform self-acupressure.
15964351|NCT03155737|Other|Knee health education|A course regarding knee health will be offered to the subjects in this group.
15964352|NCT03155724|Device|MultiPole Pacing|CRT non-responders are programmed with MultiPole pacing ON.
15964353|NCT03155711|Procedure|HFNC group|Positive pressure plus supplemental oxygen through a high flow nasal oxygen device
15964354|NCT03155711|Procedure|Standard group|Supplemental oxygen through venturi mask
15964355|NCT03155698|Combination Product|microneedling and Platelet rich plasma|"Patient's skin is first cleaned with ethyl alcohol. Topical anaesthetic cream is then applied to skin for 30 min. Once anaesthesias is fully developed, Dermapen will be applied on the lesional skin in four direction, vertical, horizontal and the two diagonal until pin point bleeding occur which will be gently massaged.
~After ten minutes the prepared platelet rich plasma will be applied topically and after about 2 minutes. Occlusive dressing will be done and kept for 1 day then the patient will use topical antibiotic. The procedure will be repeated every 15 days."
15964356|NCT03155698|Radiation|NB-UVB phototherapy|All patients will receive NB-UVB twice weekly for maximum 6 months, starting with a dose of 0.21 J/cm² independent of skin type and increased by 20% every session until we reach the minimal erythema dose
15964357|NCT03155672|Behavioral|Art therapy|Art Therapy
15964358|NCT03155646|Drug|Dexmedetomidine|patients will receive ultrasound-guided TAP block using 0.3 ml/kg levobupivacaine (0.125%) with a maximum volume of 20 ml each side + 0.5 ug/kg dexmedetomidine Hydrochloride dissolved in 2 ml normal saline (NaCl 0.9%)
15964359|NCT03155646|Drug|Clonidine|patients will receive ultrasound-guided TAP block using 0.3 ml/kg levobupivacaine (0.125%) with a maximum volume of 20 ml + 0.5 ug/kg clonidine dissolved in 2 ml normal saline (NaCl 0.9%)
15964360|NCT03155646|Drug|Levobupivacaine|patients will receive ultrasound-guided TAP block using 0.3 ml/kg levobupivacaine (0.125%) with a maximum volume of 20 ml + 2 ml normal saline (NaCl 0.9%).
15964361|NCT03155633|Other|Athletics track|Running at 95-105% aerobic Threshold on athletics track 48h, 96h, 144h after the race. Control heart devices
15964362|NCT03155633|Other|Elliptical machine|Running at 95-105% aerobic Threshold on elliptical machine 48h, 96h, 144h after the race. Control heart devices
15964380|NCT03155607|Behavioral|Virtual Reality Distraction|Patient will utilize a virtual reality device during wound care.
15964381|NCT03155594|Device|Freestyle Libre|Continuous glucose monitoring patch
15964382|NCT03155581|Behavioral|User intervention|To make participants aware of the lack of participation in screening programs and its consequences, and help to manage obstacles to participation
15964383|NCT03155581|Behavioral|Health professional intervention|To provide information on the low attendance of migrants to cervical cancer screening and tools to improve the situation
15964384|NCT03155568|Procedure|sciatic nerve block|sciatic nerve block at popliteal fossa
15964385|NCT03155568|Procedure|ankle block|block of major nerves supplying the foot at the level of the ankle
15964386|NCT03155568|Drug|Bupivacaine|blocking the lower limb nerve supply at the level of the popliteal fossa and ankle using the local anesthetic bupivacaine
15964387|NCT03155555|Other|Measurement of aortic and carotid Doppler peak systolic velocity variation|Aortic peak systolic velocity variation to be measured by echocardiography from apical five chamber and suprasternal windows alongwith carotid peak systolic velocity variation by Doppler ultrasound simultaneously at intermittent time points intermittently.
15964388|NCT03155529|Procedure|radical hysterectomy|A standard radical hysterectomy with lymphadenectomy was performed. Static and dynamic MRI were performed. A suggested urodynamic examination was done according to the ICS. A 3D reconstruction technique was used to construct the 3D model of the pelvis, pelvic floor muscle, pelvic organ such as bladder and urethral.
15964389|NCT03155516|Other|Good pain management (GPM) procedure|"In the GPM ward, a close pain assessment will be carried within 1 hour after admission. After the assessment, patient will be given analgesic treatment as needed, by acceptable route, frequency and dosage. A good titration is required in GPM ward. Patient will be close monitor his/her pain level regarding pain score. In opioid use, when patient complains patient level ≥ 4, low dose strong opioids will be introduced in patient suffering with moderate pain.
~Compare with current practice, GPM ward will perform pain assessment with higher frequency for adjusting of analgesic medications if required."
15964390|NCT03155516|Other|Current practice procedure|Current practice clinical procedure for pain management
15964391|NCT03155503|Drug|SUVN-911|Oral Tablet
15964392|NCT03155503|Drug|Placebo|Oral Tablet
15964393|NCT03155490|Behavioral|Leadership training|Subjects randomized to the experimental arm of the study will receive an additional 4 hours of simulation-based trauma team leadership training. This training is in addition to the baseline 2 hours of trauma leader training and orientation all subjects receive.
15964394|NCT03155477|Dietary Supplement|"Cholecalciferol and C. Xanthorrhiza"|Cholecalciferol are given 400 IU 3 times daily for 3 months C. Xanthorrhiza are given 200 mg 3 times daily for 3 months
15964395|NCT03155477|Dietary Supplement|"Cholecalciferol and placebo"|Cholecalciferol are given 400 IU 3 times daily for 3 months Placebo are given 3 times daily for 3 months
15964396|NCT03155464|Procedure|Order of two elements of surgical procedure|Please see the arm/group descriptions for the order of elements of the surgical procedure in group 1 and group 2.
15964397|NCT03155464|Drug|Indocyanine Green|Intraoperative ICG has been validated to correlate to postoperative outcomes. ICG is administered by means of peripheral or central intravenous access, is excreted exclusively by the liver into the bile, and is not associated with risk for nephrotoxicity. We will be using a concentration of 2.5mg/cc. 12.5mg will be administered at each injection of ICG. Complete washout of the ICG occurs after 15 minutes, plenty of time considering the interval surgery that must occur. As per the protocol, ICG will be administered 3 times during the surgery. The patients will receive a total of 37.5mg of ICG, well below the recommended threshold of 2mg/kg. No significant toxic effects have been observed in humans with the high dose of 5 mg/kg of body weight.
15964398|NCT03155451|Diagnostic Test|methylation markers screening|ctDNA extraction from plasma samples;bisulfite-treated DNA;DNA methylation levels by deep sequencing-Sequencing; data analysis
15964399|NCT03155438|Diagnostic Test|Oxidative stress-related gene expression (RNA expression)|Oxidative stress-related gene expression (RNA expression),Superoxide dismutase 1 (SOD1) , SOD2 , Glutathione peroxidase (GPX) and Inducible nitric oxide synthase (iNOS) , measured by Real time PCR technique.
15964400|NCT03155438|Diagnostic Test|oocyte competence biomarkers|Oocyte competence biomarkers ,GDF9, BMP15, Amphiregulin and CoQ10 measured by ELISA
15964401|NCT03155425|Drug|SHR-1210|A humanized monoclonal immunoglobulin
15964402|NCT03155399|Other|Proprioceptive based training (PBT)|During the PBT patient will stay in supine position with the upper limbs positioned in symmetric posture. He/She will be asked to move both limbs with the same frequency performing bilateral flexion-extension of one of the upper limb districts according to the available free ROM of the target joint. The movement execution of the affected arm will be supported by the physiotherapist performing passive movement at the same rhythm, as the one executed with the unaffected side. Patient will be asked to focus the attention on the movement performed against gravity, which will be reinforced by a verbal command. Afterwards, the physiotherapist will fully support movement execution coherently with the patient's movement initialization. The active movement performed voluntarily by the patient with unaffected limb will be considered as the reference movement, that the physiotherapist has to emulate passively, by synchronization of passive movement executed in phase with the affected side.
15964403|NCT03155399|Other|Conventional neuromotor treatment (CNT).|The patients randomized to the CNT group will be asked to perform exercises for postural control, exercises for hand pre-configuration, exercises for the stimulation of manipulation and functional skills, exercises for proximal-distal coordination. All the exercises will be performed with or without the assistance of a physiotherapist. The upper limb motricity will be trained with progressive complexity.
15964404|NCT03155386|Other|Angiommamography|"A blinded central re-reading of the acquisition technique will be carried out by 3 radiologists (2 seniors and 1 junior) who will evaluate:
~The intensity of lesion enhancement
~The presence and type of artefacts on the recombined images.
~The quality of low-energy images according to recognized criteria for mammography.
~The gold standard will be histology (biopsies or surgery) or follow-up to 1 year for non-biopsied benign lesions"
15964405|NCT03155373|Diagnostic Test|Cardiac catheterisation|Pre-operative left heart catheterisation +/- right heart catheterisation
15964406|NCT03155373|Diagnostic Test|Cardiopulmonary exercise testing|Pre and post-operative cardiopulmonary exercise testing
15964407|NCT03155373|Diagnostic Test|Pulmonary function tests|Pre and post-operative pulmonary function tests
15964408|NCT03155373|Diagnostic Test|Cardiac MRI|Pre and post-operative cardiac MRI
15964409|NCT03155373|Other|Quality of life survey|Pre and post-operative quality of life survey (SF36)
15964410|NCT03155373|Procedure|Mitral valve operation|Clinically indicated mitral valve repair/replacement +/- coronary artery surgery +/- tricuspid valve surgery +/- atrial fibrillation surgery
15964411|NCT03155373|Procedure|Myocardial biopsies|Right and left epicardial ventricular biopsies taken at time of clinically indicated surgery
15964412|NCT03155360|Other|Non interventional study|Non interventional study
15964417|NCT03155334|Other|PIS User Testing|"PIS User Testing based on an iterative 4-step process in a cohort of participants (the target group):
~individual reading of the text;
~individual questionnaire for a quantitative and qualitative evaluation;
~a brief semi-structured interview to each participant;
~a text revision to address any problems identified from participant feedback."
15964418|NCT03155321|Other|It's an observational study - no intervention is planned|No intervention is planned
15964419|NCT03155308|Device|Pentax chromoendoscopy (i-scan and Optical Enhancement)|All lesions will be evaluated using the 3 i-scan modes and the 2 OE modes without magnification. The lesion size data, location and macroscopic shape of the lesions based on the Paris classification will be recorded. Finally all lesions will be classified in real-time into 3 types based on NICE classification (NICE 1, hyperplastic polyps; NICE 2, adenoma and superficial submucosal carcinoma; NICE 3, SM-d invasive carcinoma). A level of confidence (high or low) will be assign in each stage. Polyp's images will be photographically and videotape recorded. All polyps will be resected or biopsied for histopathological examination used as the criterion standard for the analysis.
15964420|NCT03155295|Other|Physical reality simulation|Using 3-D printing and polymer technology, the investigators will construct patient specific simulated hydrogel models designed from patients' imaging, incorporating the necessary anatomy, physiology and pathology specific to each patient. These models are constructed at the Laboratory for Simulation-based Translational Research at the Department of Urology. Group 1 urologists will rehearse the minimally-invasive partial nephrectomy (MIPN) surgery using these patient-specific models.
15964421|NCT03155295|Other|Virtual reality simulation|The DaVinci surgical skills simulator system uses a virtual reality surgical simulation platform that encompasses a variety of basic exercises specifically designed to give users the opportunity to improve their proficiency with the da Vinci surgeon console controls and basic robotic surgical skills. All urologists have already completed a basic robotic skills curriculum. Group 2 urologists will complete a refresher module on the virtual reality simulator.
15964422|NCT03155282|Procedure|EUS-E to measure liver and spleen stiffness.|The EUS-E quantitative evaluation will be performed on the left hepatic lobe transgastrically. For the SR calculation, the area A will be manually selected including as much of hepatic tissue as possible and the area B will be selected on the red gastric mucosa. For the strain histogram measurement, the ROI selected will have a surface of 60 mm2. The same procedure will be repeated 10 times at different points on the left hepatic lobe and finally the mean SR and SH values will be calculated. The same sequence will be repeated to measure the spleen stiffness. Finally the azygos vein (AV) will be evaluated using EUS Doppler. The mean velocity and the AV diameter will be measure and the AV blood flow volume index (BFVI) will be calculated.
15964423|NCT03155269|Dietary Supplement|Fortified Beverage Powder|The tumbler will be filled with water up to the 200 mL mark. The entire contents of one sachet (Fortified beverage powder) will be gradually emptied in the tumbler with intermittent stirring to avoid formation of lumps. The reconstituted product will be consumed by the participants immediately orally.
15964424|NCT03155269|Dietary Supplement|Non fortified beverage Powder|The tumbler will be filled with water up to the 200 mL mark. The entire contents of one sachet (Non fortified beverage powder) will be gradually emptied in the tumbler with intermittent stirring to avoid formation of lumps. The reconstituted product will be consumed by the participants immediately orally.
15964425|NCT03155256|Procedure|EUS-guided injection of coils with cyanoacrylate|First a standard diagnostic upper endoscopy will be performed in order to classify the varices according to the classification of Sarin and Kumar. Only GOV II and IGV I varices will be included. Once the patient is conceder a candidate will be treated with Coils plus CYA (Group A)
15964426|NCT03155256|Procedure|EUS-guided injection of coils|First a standard diagnostic upper endoscopy will be performed in order to classify the varices according to the classification of Sarin and Kumar. Only GOV II and IGV I varices will be included. Once the patient is conceder a candidate will be treated with only coils (Group B).
15964427|NCT03155230|Other|no intervention|no intervention
15964428|NCT03155204|Drug|tiotropium pMDI|inhalation
15964429|NCT03155191|Biological|TBI-1501|"Phase-I portion:
~Cyclophosphamide is administered for conditioning medication of TBI1501, that is CD19-CAR-T cells, (cohort -1: 3×10^5 cells/kg, cohort 1: 1×10^6 cells/kg, cohort 2: 3×10^6 cells/kg).
~Phase-II portion:
~Recommended dose of Phase-II part will be administered. Cyclophosphamide will be administered as conditioning. The end of study will be Week 52 after administration of TBI-1501."
15964430|NCT03155178|Drug|3M CHG/IPA Prep|Apply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes.
15964431|NCT03155178|Drug|ChloraPrep|Apply topically to intact dry skin (abdominal site) for 30 seconds or moist skin (inguinal site) for 2 minutes.
15964432|NCT03155165|Device|Retroview™ colonoscope|The colonoscopy will be performed twice, with 2 different scopes, in tandem, by 2 endoscopists trained on retroflex withdrawal. First a conventional HD colonoscope with I-Scan will be used following the standard withdrawal technique and then the second endoscopist blinded to the first colonoscopy results, will perform the second colonoscopy using the Retroview™ scope with a combining withdrawal (retroflexed + standard withdrawal). The endoscopist that will perform each colonoscopy will be chosen randomly. After the examination, the endoscopist will fill a questionnaire detailing each polyp / adenoma found including the size and location.
15964433|NCT03155152|Other|DECT|The DECT program consists of a 4-week training intervention with three weekly sessions of high-intensity interval training, in which during each exercise bout the workload is imposed in a decremental fashion.
15964474|NCT03154814|Drug|control|conventional CPB was applied without ulinastatin treatment
15964434|NCT03155152|Other|HIIT|The HIIT program consists of a 4-week training intervention with three weekly sessions of high-intensity interval training, in which during each exercise bout the workload is kept constant.
15964435|NCT03155139|Diagnostic Test|Aldosterone/renin ratio (ARR) testing|Plasma aldosterone concentration tests, Direct renin concentration tests
15964436|NCT03155139|Diagnostic Test|Confirmatory tests|Captopril challenge test, Saline infusion test
15964437|NCT03155126|Other|Fluid resuscitation|Patients in the saline group were resuscitated with saline, patients in the other group were resuscitated with acetated Ringer's sodium
15964438|NCT03155113|Other|blood drawing|Before starting therapy a blood sample will be collected from any subject.
15964439|NCT03155100|Drug|Carfilzomib for Inj 60 milligram (MG)|All patients will have similar effective study drug combination; karfilzomib plus elotuzumab plus dexamethasone
15964440|NCT03155100|Drug|Elotuzumab 400 MG|All patients will have similar effective study drug combination; karfilzomib plus elotuzumab plus dexamethasone
15964441|NCT03155100|Drug|Dexamethasone|All patients will have similar effective study drug combination; karfilzomib plus elotuzumab plus dexamethasone
15964442|NCT03155087|Drug|Metformin|
15964443|NCT03155074|Behavioral|High-intensity training|The exercise program will include a cardiovascular warm-up, high intensity interval training and progressive resistance training (PRT). The intervention will focus on high-intensity training, mainly by uphill walking on a treadmill at 80-95 % of the maximal heart rate and PRT in three series at 6-12 RM by leg press, chest press, back extension, seat row, and front raises. During the first four weeks, the patients will be introduced to the program while focusing on safety, techniques and familiarization. The endurance intensity and strength load will then continuously increase based on the patients' improvement, tolerance of dyspnea, and feelings of well-being or fatigue on each exercise day.
15964444|NCT03155061|Drug|ONO-4578|ONO-4578 specified dose on specified days
15964445|NCT03155061|Drug|ONO-4538|ONO-4538 specified dose on specified days
15964446|NCT03155048|Drug|oral estrogen replacement therapy|oral estradiol group for endometrial preparation
15964447|NCT03155048|Drug|Estradiol transdermal patch|transdermal estradiol group for endometrial preparation
15964448|NCT03155035|Drug|Albendazole|Albendazole 400 mg chewable tablets (200 mg each) Two tablets as a single dose recommended as ovicidal, larvicidal and vermicidal against all soil transmitted helminths
15964449|NCT03155035|Dietary Supplement|Calcium 400 mg + Vitamin D 2.5 mcg|2 chewable tablets provide recommended daily allowance for calcium and vitamin D
15964450|NCT03155022|Device|Remote ischemic conditioning and intracoronary ischemic conditioning|"RIC: Four cycles of [5 min brachial cuff inflation at 200 mmHg followed by 5 min of cuff deflation] started as soon as possible prior to PCI reperfusion. At least one full cycle (inflation + deflation) has to be completed before PCI reperfusion.
~ICIC: Four cycles of [1 min balloon inflation followed by 1 min balloon deflation] started as soon as possible after reopening of the culprit coronary artery (maximum within 3 minutes after reflow). The balloon will be placed carefully above the culprit lesion so as to minimize potential micro-embolization."
15964451|NCT03155022|Device|Patients with no remote ischemic conditioning and no intracoronary ischemic conditioning|Brachial cuff is positioned during 40 minutes but not inflated. No intracoronary balloon inflation.
15964452|NCT03155009|Drug|Alectinib|600 mg orally BID with food
15964453|NCT03154996|Drug|Topotecan|"Topotecan is a chemotherapeutic agent that is a topoisomerase inhibitor. TPT is administered through an externalized catheter and external microinfusion pump.
~Dose: 146 micrometers (uM)"
15964454|NCT03154996|Drug|Gadolinium|Gadolinium is a widely available MRI contrast agent that is used routinely in clinical practice via IV administration, especially for imaging of intracranial tumors.
15964455|NCT03154996|Device|Synchromed II infusion pumps|Implanted subcutaneously to facilitate chronic infusion.
15964456|NCT03154983|Drug|docetaxel|Diagnosed with metastatic gastric cancer patients (including the esophagogastric junction adenocarcinoma), DS(docetaxel and Tegafur)and Mesylate apatinib 6 cycles, the specific amount of usage: DS Docetaxel 75mg/m2 D1 IV.drop 1H（one hour）, Tegafur(BSA<1.25 40mg Po bid(twice a day), BSA >=1.25-<1.5 50mg Po bid, BSA >=1.5 60mg Po bid, Q21d(21 days a cycle)); Mesylate Apatinib 500mg Po QD（once a day)） continuous use, until disease deterioration.
15964457|NCT03154970|Device|Craniocervical flexion training|The cervical stabilization will be performed with craniocervical flexion training with two weekly sessions for 6 weeks
15964458|NCT03154944|Device|Ostomy device 1|This device consists of a known adhesive and a new top film
15964459|NCT03154944|Device|Ostomy device 2|This device consists of a new adhesive and a known top film
15964460|NCT03154944|Device|Ostomy device 3|This device consists of a known adhesive and a new top film
15964461|NCT03154931|Other|CBT-SG|To support the group.
15964462|NCT03154931|Other|CFT-G|Teach compassionate skills.
15964463|NCT03154918|Drug|GLIDE|The dose and schedule of GLIDE chemotherapy was as follows: gemcitabine 800 mg/m 2 days 1, 8; Peg-ASP 2500 U/m 2 days 4; ifosfamide 1000 mg/m 2 days 1 - 3; dexamethasone 20 mg days 1 - 4; etoposide 100 mg/m 2 days 1 - 3.
15964464|NCT03154892|Procedure|Intracameral injection|Intracameral Conbercept injection for the treatment of NVG
15964465|NCT03154892|Procedure|Intravitreal injection|Intravitreal Conbercept injection for the treatment of NVG
15964466|NCT03154879|Device|Amplitude integrated electroencephalography|Frontal Amplitude-integrated Electroencephalogram in Early Prognostication After Cardiac Arrest
15964467|NCT03154866|Dietary Supplement|Lactobacillus kefiri LKF01 DSM32079|Lactobacillus kefiri LKF01 DSM32079 in drop formulation. 5 drop/daily for 21 days
15964468|NCT03154866|Dietary Supplement|Placebo|Placebo in drop formulation. 5 drop/daily for 21 days
15964469|NCT03154853|Other|Behavioral: short foot exercise|Behavioral: short foot exercise 30 repetitions per section (10 seconds for each contraction, 1 minute between sections), 3 times/ week, 3 weeks
15964470|NCT03154840|Drug|Eutropin 4IU, Eutropin AQ 12IU, Eutropin Pen 36IU|Investigate the Relative Bioavailability among Different Eutropin Formulations
15964471|NCT03154827|Drug|BL-8040|Subjects will receive once daily SC injections of 1.25 mg/kg of BL-8040 on the first 3 days of each cycle.
15964472|NCT03154827|Drug|Atezolizumab|Subjects will receive Atezolizumab 1200 mg by IV infusion on Day 2 of every cycle.
15964473|NCT03154814|Drug|ulinastatin|ulinastatin (10000 U/kg and 5000 U/kg/h) was administered during CPB
15964475|NCT03154801|Other|Paramedical care|Paramedical early detection of sexual dysfunction and sexual health counseling
15964476|NCT03154775|Biological|C-CAR011|Autologous 2nd generation CD19-directed CAR-T cells, single infusion intravenously at a target dose of 0.5-5.0 x 10^6 anti-CD19 CAR+ T cells/kg
15964477|NCT03154762|Device|NIPPV|Application of chronic distension of the airway through NIPPV to produce a reduction in bronchial hyperreactivity.
15964478|NCT03154762|Device|CPAP|4 cmH2O CPAP as the minimum pressure necessary to mobilize the air flow and avoid the space death with no effect on the ventilation.
15964480|NCT03154736|Other|Interview|Individual interview and group interview Socio-economic questionnaire
15964481|NCT03154723|Drug|Vitamin A|Vitamin A daily dose 1500IU/day will be added to infant's enteral feeds in drop form as soon as minimal feeding is introduced. The vitamin A supplementation was last for 28 days.
15964482|NCT03154710|Device|MOOVCARE|web-mediated follow up
15964483|NCT03154697|Other|Data collection of sleep disturbances in individuals with SMS|Data related to Smith-Magenis syndrome and sleep disturbances are collected through a web or phone survey
15964484|NCT03154684|Other|STARK intervention|"The STARK Intervention is a new care concept for hip fracture patients that enable hip fracture patient to return to their home directly after discharge from acute care. The STARK comprehensive autonomy health care package includes following services;
~Multidisciplinary collaboration of geriatricians, nurses and Spitex (ambulant nursing service at home) starting already during acute care
~Inspection of the environment at the patient's home
~Care and autonomy support
~Social life support
~Secondary prevention strategies:
~Home exercise program (3x/weeks)
~Protein enriched food preparation (20g whey protein/day)
~Support to take vitamin D supplementation (2000 IU/day)
~Recommendation and support to eat calcium rich foods
~Motivation to be physically active"
15964485|NCT03154684|Other|Standard of Care|Standard of Care involves inpatient rehabilitation or home-based or inpatient transitional nursing care
15964486|NCT03154671|Other|Geriatric assessment and management|Each participant will receive a comprehensive geriatric assessment at baseline. Based on the issues identified, a tailored care plan will be developed with the participant to address the issues identified.
15964487|NCT03154658|Drug|Ropivacaine 0.35%|The serratus plane block is used to supplement the pain management of a patient receiving a surgical procedure of the chest wall or breast.
15964488|NCT03154645|Drug|Ibuprofen|non-steroidal anti-inflammatory drug
15964489|NCT03154645|Drug|Acetazolamide|a diuretic
15964490|NCT03154632|Device|Ultrasound Therapy|Ultrasound equipment will be used, choosing a continuous mode, with a frequency of 1MHz and an intensity of 1.0 W/cm2. The technique will be applied during 6 minutes with circular movements and a speed of approximately between 2.5 and 4 centimeters per second.
15964491|NCT03154632|Device|Digital Capacitive Diathermy Therapy|"The DCD equipment will be used choosing the musculotendinous injury FAST program which lasts 6 minutes. The applicator will move with a velocity approximately between 2.5 and 4 centimeters per second."
15964492|NCT03154619|Drug|0.1% TR 987|TR 987 0.1%
15964493|NCT03154619|Drug|Placebo gel|Placebo gel twice weekly for 4 weeks, then once weekly for 8 weeks. Gel will be applied to cover the wound cavity and wound surface to a thickness of 5 mm.
15964494|NCT03154606|Other|Micellar Casein (#1)|The study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from micellar casein. All ingredients are GRAS listed and approved.
15964495|NCT03154606|Other|Micellar Casein (#2)|The study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from micellar casein. All ingredients are GRAS listed and approved.
15964496|NCT03154606|Other|Calcium Caseinate|The study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from calcium casein. All ingredients are GRAS listed and approved.
15964497|NCT03154606|Other|Sodium Caseinate|The study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from sodium caseinate. All ingredients are GRAS listed and approved.
15964498|NCT03154606|Other|Milk Protein Isolate|The study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from milk protein caseinate. All ingredients are GRAS listed and approved.
15964499|NCT03154606|Other|Pure Protein Blend|The study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from pure protein blend. All ingredients are GRAS listed and approved.
15964500|NCT03154606|Other|Whey Protein Isolate|The study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from whey protein blend. All ingredients are GRAS listed and approved.
15964501|NCT03154606|Other|Native Whey Protein Isolate|The study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from Native Whey Protein Isolate. All ingredients are GRAS listed and approved.
15964643|NCT03153280|Drug|Oxaliplatin|Dose as used in standard of care - 130 mg/m2.
15964644|NCT03153280|Drug|Capecitabine|Dose as used in standard of care - 800 - 1000 mg/m2
15964778|NCT03152175|Drug|Propranolol Hydrochloride|1mg / kg of propranolol hydrochloride, oral capsule
15964502|NCT03154606|Other|Soy Protein|The study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from soy protein. All ingredients are GRAS listed and approved.
15964503|NCT03154606|Other|Pea Protein|The study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from pea protein. All ingredients are GRAS listed and approved.
15964504|NCT03154606|Other|Native Whey: Micellar Casein (50:50) blend|The study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain protein sourced predominantly from native whey: micellar casein (50:50) blend. All ingredients are GRAS listed and approved.
15964505|NCT03154606|Other|Carbohydrate Control|The study participants will be provided with breakfast meals to consume. The energy content of the breakfast meals will be standardized to ~250 kcal. The meals will include the same fat content but will contain predominantly carbohydrates as a control. All ingredients are GRAS listed and approved.
15964506|NCT03154593|Other|Stage 2 - Bariatric Surgery|This observational study follows patients after routine bariatric surgery.
15964507|NCT03154580|Drug|N-acetyl cysteine|Participants will receive 4 capsules at 11:15am on each experimental session day.
15964508|NCT03154567|Drug|Yohimbine|Yohimbine (0mg, 20mg, or 40 mg) will be administered at 11:00am on each of the experimental sessions.
15964509|NCT03154541|Drug|Synrinse|"Non-CF Cohort The first 10 non-CF subjects will be instructed to once daily irrigate both nasal passages with SynRinse (supplied) delivered via nasal irrigation using the NeilMed® Sinus Rinse™ system for 1 week. The subjects will be asked to refrain from performing any sinus irrigations during the test treatment period with any product including saline.
~The second set of 10 non-CF subjects (if the study continues to this point) will be instructed to irrigate both nasal passages twice daily (rather than once daily) for one week with SynRinse (supplied). The subjects will be asked to refrain from performing any sinus irrigations during the test treatment period with any product including saline.
~CF Cohort The first 5 subjects in the CF cohort will irrigate with with SynRinse delivered via nasal irrigation using the NeilMed Sinus Rinse system for 1 week. The second set of 5 subjects with CF will irrigate both nasal passages twice daily for one week with SynRinse."
15964510|NCT03154528|Diagnostic Test|serum vitamin D level by ELISA|The study will include 60 patients with androgenetic alopecia (30 males & 30 females) and 30 age and sex-matched healthy volunteers. Study subjects will be recruited from the Dermatology Outpatients' Clinic, Assiut University Hospitals, Assiut, Egypt. Informed consent will be obtained from all subjects
15964511|NCT03154515|Drug|Ingavirin|
15964512|NCT03154515|Drug|Placebo|
15964513|NCT03154502|Diagnostic Test|Urinary sodium excretion|Urinary sodium and potassium were measured using the Ion-Selective Electrode (ISE) indirect Na-K-Cl for Gen.2 (Roche Diagnostic, Switzerland).
15964514|NCT03154489|Other|acenocoumarol|medication review with follow-up in acenocoumarol treatment
15964515|NCT03154489|Other|control|group
15964516|NCT03154476|Drug|Sildenafil|Sildenafil will be initiated at 5 mg 3 times per day for the first week, and titrated to 10 mg 3 times per day for the second week and 20 mg 3 times per day from the third week to the end of the study period, 12 months.
15964517|NCT03154476|Drug|Placebo|Placebo capsules matching study drug
15964518|NCT03154463|Procedure|TAP Blocks|TAP blocks were performed using ultrasound as a guide and injected on three points on trans abdominal plane using 100 mm stimuplex needle and 0.25% bupivacaine with total volume of 20 ml in each point (with total of 60 ml in three points)
15964519|NCT03154463|Procedure|continuous epidural infusion|Continuous epidural infusion was given with epidural regimen of 0.25% bupivacaine without any adjuvant
15964520|NCT03154450|Device|EncoreAnywhere with data available to review|Encore Anywhere will be installed and available for review by the clinical team
15964521|NCT03154450|Device|EncoreAnywhere with no data available to review|Encore Anywhere will be installed but not available for review by the clinical team
15964522|NCT03154437|Biological|Emicizumab|Participants will receive emicizumab at a loading dose of 3 milligrams per kilogram (mg/kg) per week subcutaneously (SC) for 4 weeks, followed by a maintenance dose of 1.5 mg/kg per week SC thereafter. Treatment with emicizumab will continue until unacceptable toxicity, withdrawal of consent, participant or physician decision to discontinue treatment, death, the participant is able to obtain commercial drug after emicizumab becomes commercially available, or the sponsor decides to discontinue emicizumab clinical development, whichever occurs first.
15964523|NCT03154424|Procedure|External fixation in treatment the distal radius fracture|Compare two techniques
15964524|NCT03154411|Drug|ABY-029|A minimum of 6 and a maximum of 12 adult patients with a diagnosis of primary soft-tissue sarcoma will be enrolled. Initial diagnostic biopsy specimens will be analyzed for EGFR positivity (an EGFR pathology score ≥ 1) by immunohistochemistry following routine diagnostic processing by Pathologist. Patients will be administered a single intravenous dose of ABY-029 1-3 hours before surgery.
15964525|NCT03154385|Drug|Rituximab (Mabthera ®) Belimumab (Benlysta ®)|Rituximab (Mabthera ®): 1g IV at W0 and W2 Belimumab (Benlysta ®) : 10mg/kg IV, W0 + 2days, W2 + 2 days, W4, W8, W12
15964526|NCT03154372|Other|Expert supervised practice with validated metrics|
15964527|NCT03154372|Other|self guided practice with validated metrics|
15964528|NCT03154359|Drug|Atomoxetine Hydrochloride|Atomoxetine dose adjusted to achieve pre-defined concentration
15964529|NCT03154333|Drug|diacerein 1% ointment|diacerein 1% ointment administered topically
15964530|NCT03154333|Drug|A placebo ointment|vehicle ointment administered topically
15964531|NCT03154320|Other|Same-Day Treatment|Treatment with ART or TB medication on day of HIV diagnosis
15964532|NCT03154320|Other|Standard treatment|Standard treatment
15964533|NCT03154307|Device|Low frequency repeated TMS (LF-rTMS)|Each patient will then begin treatment with 14 minute sessions of 1 Hz rTMS or sham rTMS, 120% minimum threshold (MT), and 800 stimuli on the position of the calculated 3D source using EEG, MRI, and digitized electrode locations. Two different timelines of delivering the rTMS will be compared against a sham/delayed treatment group.
15964645|NCT03153267|Drug|Doxycycline 100 MG Oral Tablet bid, 7 days|Patients will receive doxycycline for 7 days.
15964534|NCT03154294|Drug|paclitaxel|Paclitaxel will be diluted prior to infusion in 0.9% Sodium Chloride for Injection, USP; 5% Dextrose Injection, USP; 5% Dextrose and 0.9% Sodium Chloride Injection, USP; or 5% Dextrose in Ringer's Injection to a final concentration of 0.3 to 1.2mg/mL. At ambient temperature (approximately 25°C) and room lighting conditions the solution is physically and chemically stable for up to 27 hours. The diluted product will be prepared and stored in glass, polypropylene, or polyolefin containers; DEHP-containing (polyvinyl chloride (PCV)) containers should not be used. Paclitaxel will be administered using a vented Paclitaxel set with in-line 0.22-micron filter and run over 1 hour.
15964535|NCT03154294|Drug|TAK-228|TAK-228 will be provided in 30-ct, 60-cc high density polyethylene (HDPE) bottles with polypropylene, child-resistant caps and induction seal. TAK-228 will be administered on an empty stomach. It is recommended that each dose of TAK-228 + TAK-117 be given PO with 8 ounces (240 mL) of water. Patients should be instructed to refrain from eating and drinking (except for water and prescribed medications) for 2 hours before and 1 hour after each dose.
15964536|NCT03154294|Drug|TAK-117|TAK-117 will be provided in 30-ct, 60-cc high density polyethylene (HDPE) bottles with polypropylene, child-resistant caps and induction seal. TAK-117 will be administered on an empty stomach. It is recommended that each dose of TAK-228 + TAK-117 be given PO with 8 ounces (240 mL) of water. Patients should be instructed to refrain from eating and drinking (except for water and prescribed medications) for 2 hours before and 1 hour after each dose.
15964537|NCT03154281|Drug|niraparib|Niraparib 100 mg will be administered orally once daily continuously. Niraparib will be administered as a flat-fixed dose (100mg, 200 mg, or 300 mg daily) depending on the cohort the patient is enrolled to, and not by body weight or body surface area. Each dose should be swallowed whole without chewing. The consumption of water is permissible. Patients should take doses at approximately the same times each day, and record this information in the patient diary. Patients will be provided with a diary in which to record their intake of study drug. However, the actual number of doses taken by the patient must be calculated from the number of tablets dispensed and returned.
15964538|NCT03154281|Drug|everolimus|Everolimus 5 mg tablets will be used. Everolimus will be self-administered orally on a daily basis and doses will either be 5 mg (1 tablet) thrice weekly or 5 mg daily depending on the cohort the patient is enrolled to. Each cycle will be 28 days; everolimus will be taken continuously with no rest between cycles.
15964539|NCT03154255|Behavioral|Mediterranean-Style Diet Educational Training|"The intervention consists in a standard diet according to routine clinical practice + a 30 minutes Mediterranean-Style Diet educational training with explanation of Mediterranean pyramid + gamification to Mediterranean diet inside the Hospital and at home throughout The Mediterranean Goose."
15964540|NCT03154229|Other|Smartphone-based decision-support|WHO guidelines have been adapted from paper onto a smartphone referred to as a Rehydration Calculator
15964541|NCT03154229|Other|Paper-based decision-support|WHO guidelines presented on paper
15964542|NCT03154229|Other|Pre-Assessment of practices|Observation of baseline clinical practice.
15964543|NCT03154216|Behavioral|Exercise|90 minutes of moderate-intensity walking exercise on a treadmill
15964544|NCT03154216|Other|Drink|Beverage to be consumed after exercise
15964545|NCT03154203|Other|No intervention in this study|No intervention in this study
15964546|NCT03154190|Other|Best Practice|Receive usual care
15964547|NCT03154190|Other|Laboratory Biomarker Analysis|Correlative studies
15964548|NCT03154190|Procedure|Supportive Care|Undergo health care coach support
15964549|NCT03154190|Other|Survey Administration|Ancillary studies
15964550|NCT03154177|Behavioral|Group ANC/PNC|The primary intervention is group antenatal and postnatal care wherein women receive their care in a group with other women with similar due dates. After an initial individual visit all care is given in groups although the majority of the time is dedicated to facilitated discussion and women can come for additional acute care if needed. Group antenatal care will be three group visits between 20 and 40 weeks gestation and group postnatal care will be one group visit and approximately 6 weeks post delivery.
15964551|NCT03154177|Procedure|Ultrasound+Pregnancy Testing|"Half of all study sites will receive early pregnancy testing, conducted by community health workers at community level and ultrasound for gestational age dating and early screening at the health center.
~The primary analysis will not assess the effectiveness of this intervention."
15964552|NCT03154164|Device|Ultrasonic tissue coagulation dissection|ultrasonic coagulation for dissection during laparoscopic cholecystectomy
15964553|NCT03154151|Behavioral|Online Cognitive-Behavioral Therapy|Each participant will complete writing assignments focusing on how their experiences during the 9/11 attacks or the WTC recovery effort continue to affect their life, and the therapist will provide written responses and guidance within two work days, through the secure Web platform. Participants will be asked to complete one to two 45-minute writing assignments per week, over a six-week period (11 in total). Participants are asked not to begin new psychotherapy or medication with an outside therapist or doctor during the study.
15964554|NCT03154151|Behavioral|Online Supportive Therapy|Each participant will complete writing assignments focusing on problems and stressors that are currently affecting their life, and the therapist will provide written responses and guidance within two work days, through the secure Web platform. Participants will be asked to complete one to two 45-minute writing assignments per week, over a six-week period (11 in total). Participants are asked not to begin new psychotherapy or medication with an outside therapist or doctor during the study.
15964555|NCT03154138|Device|The prismatic adaptation (PA)|Prismatic adaptation (PA) is based on the wearing of a pair of glasses producing a visual field deviation of 10° to rightward. While wearing theses glasses, the patient is asked to perform fast pointing movements towards targets by the right hand. Targets are symmetrical located at 10° in the right and left side in front of the patient. The order of pointing between these two targets is pseudo-randomly by the therapist. At the beginning of the exposure, the patient performs pointing movements with a shift toward the right side (initial errors consecutive to the prism deviation). Taking into account theses errors, the patient then compensates the optical deviation. After removing the prismatic glasses, the asked pointing movement to the targets is once again shifted but to the left side this time (after-effects attesting the prismatic adaptation)
15964646|NCT03153267|Drug|Doxycycline 100 MG Oral Tablet bid, 14 days|Patients will receive doxycycline for 14 days.
15964647|NCT03153267|Drug|Controls without a history of lyme disease.|No intervention.
15964648|NCT03153254|Device|Test upper limb robot assisted therapy device|During 1 session of 1/2 hour.
15964556|NCT03154138|Device|The sham prismatic adaptation (S-PA)|"The sham prismatic adaptation (S-PA) is based on the wearing of a pair of glasses producing no visual field deviation. Theses sham glasses is identical with theses used in PA group without the optical deviation. The conditions are similar with theses in the PA group.
~The procedure with the sham glasses are similar with these one used in the PA group: While wearing the sham glasses, the patient is asked to perform fast pointing movements towards targets by the right hand. Targets are symmetrical located at 10° in the right and left side in front of the patient. The support with targets are the same as these one used in the PA group. The order of pointing between these two targets is pseudo-randomly by the therapist. At the beginning of the exposure, the patient performs pointing movements without shift. No compensation of movement is observed. After removing the prismatic glasses, the asked pointing movement to the targets is not shifted (No after-effects observed)"
15964557|NCT03154125|Drug|Sayana® Press|The active ingredient in Sayana® Press is Medroxyprogesterone acetate (MPA). Sayana® Press (MPA injectable suspension, 104 mg/0.65 mL, pre-filled in the UnijectTM delivery injection system) for subcutaneous injection.
15964558|NCT03154112|Device|Measurement of oxygen consumption and caloric expenditure|This study will involve an ~1 hour, single point in time measurement of oxygen consumption, carbon dioxide production, resting energy expenditure, and respiratory quotient using two methods while patients are breathing an FiO2 of 40%. These measurements will be measured using the novel, responsive device and compared with gas collected simultaneously collected from a Douglas bag.
15964559|NCT03154086|Drug|GSK3352589|It will be available in the dose of 1, 5, 25 and 100 mg tablet for oral administration.
15964560|NCT03154086|Drug|Matching Placebo|It will be available across all strengths to match active drug in the form of tablet for oral administration.
15964561|NCT03154073|Behavioral|Moderate Intensity Exercise Training (MOD)|For the first 4 weeks, participant will be asked to complete 3 days of exercise/week at 50-65% heart rate maximum. Sessions will last between 30-40 minutes excluding the warm-up and cool down (5-10 minutes). After 4 weeks, the MOD group will be expected to match the exercise prescription. The exercise prescription for the MOD group for weeks 5-12 will be 4 days/week, 45 min/session completed at 60-65% heart rate maximum.
15964562|NCT03154073|Behavioral|Vigorous Intensity Exercise Training (VIG)|The exercise lead in period will be the same as the moderate intensity exercise training program. After 6 weeks, the VIG group will be expected to match the exercise prescription. The exercise prescription for the VIG for weeks 7-12 will be 4 days/week, 45 min/session completed at 80-85% heart rate maximum.
15964563|NCT03154060|Device|Abbott FreeStyle Libre Flash Glucose Monitoring sensors|Three FGM sensors will be inserted simultaneously (one on the back of the upper arm, abdomen and thigh) and will be worn for a consecutive 14 days. Throughout the study, patients should measure capillary blood glucose (BG) with the built-in BG meter of the Freestyle Libre at least 7 times per day (before and 1-2 hours after every meal and before bedtime). Additionally, patients should scan each sensor at least every 8 hours to obtain every measured interstitial glucose value. At the end visit (after 14 days), patients will come back to the hospital to download FGM and SMBG data.
15964564|NCT03154047|Drug|NEOD001|humanized monoclonal antibody
15964565|NCT03154021|Combination Product|Next Science OTC Oral Rinse with Essential Oils|This group will receive Next Science Oral Rinse with Essential Oils and the other half will be give OTC Oral Rinse Control
15964566|NCT03154021|Combination Product|OTC Oral Rinse Control|This group will receive OTC Oral Rinse Control
15964567|NCT03154008|Behavioral|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy will follow the Adolescent Coping with Depression Course (CWD; Clarke et al., 1999), an established 16-session group treatment protocol, and consist of behavioral activation, relaxation skills, cognitive therapy, social skills, problem solving, and relapse prevention.
15964568|NCT03153995|Procedure|soft tissue expansion|"Three surgeries will be carried out for group I patients:
~Soft tissue expansion (1st surgery); at baseline
~Alveolar ridge augmentation (2nd surgery); after five weeks
~Implant surgery (3rd surgery); after six months"
15964569|NCT03153982|Drug|Ruxolitinib|15 mg or 20 mg (three or four 5 mg tablets) by mouth twice daily
15964570|NCT03153969|Device|SHOFU Beautifil II LS|Placed under manufacturer's instructions
15964571|NCT03153969|Device|3M/ESPE Filtek Supreme|Placed under manufacturer's instructions
15964572|NCT03153956|Device|Calibrated AposTherapy®|a biomechanical device including 2 hemispheric biomechanical elements attached to a platform in a form of a shoe. the biomechanical device is calibrated to each patient by a physiotherapist specialized with the treatment methodology.
15964573|NCT03153956|Device|Non-Calibrated Sham Apos Therapy Device|The comparator group will receive a non-calibrated sham device.
15964574|NCT03153943|Device|HIP Mobile e-Monitoring support|3-month community-based extended-rehabilitation e-Monitoring and Coaching support program
15964575|NCT03153943|Other|Workbook support|Printed material support
15964576|NCT03153930|Behavioral|Walking breaks|In-Lab (full sample): participants will be asked to walk on a treadmill for 3 minutes every 30 minutes at a moderate pace during a 3-hour OGTT Free-living (sub-sample; N=12): participants will be prompted via an ActivPAL vtap monitor to walk for 3 minutes every time sedentary behavior lasts longer than 30 continuous minutes
15964577|NCT03153930|Behavioral|Sitting only|In-Lab (full sample): participants will remain seated for 3 hours during an OGTT Free-living (sub-sample; N=12): participants will perform their habitual sedentary behaviors
15964578|NCT03153917|Other|melatonin and cortisol sampling|The study will take place over 15 days during which the nurses will wear an actigraphic wristband and will fulfill a sleep log. During 3 periods of 24 hours selected during these 15 days, including a 12h day shift (Day 2), a 12h night shift (Day 8) and a rest (Day 13), the participants will collect their urine by 4 to 8 hour periods, note the corresponding urine volumes and for each period, sample a 5 mL tube which will be analyzed later (6-sulfatoxymelatonin and urinary cortisol assays). The subjects will complete questionnaires at the beginning of the study (Horne and Ostberg, Insomnia Severity Index, Epworth, Pichot, Hospital Anxiety and Depression) and the days corresponding to the urine sampling (Karolinska and St Mary Hospital).
15964649|NCT03153254|Device|Training with new upper limb robot assisted therapy device|During 2 to 5 sessions of 1/2 hour.
15964650|NCT03153241|Other|No intervention|No intervention
15964651|NCT03153215|Other|treatment|We will offer Sildenafil citrate (20 mg per os three times daily until delivery) as innovative therapy to 23 women with severe IUGR ('Sildenafil-treated') in addition to fish oil and zinc supplementation.
15964579|NCT03153904|Behavioral|Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems|MATCH-ADTC (Chorpita & Weisz, 2009) is designed for children aged 6-15. Unlike most evidence-based treatments (EBTs), which focus on single disorder categories (e.g., anxiety only), MATCH is designed for multiple disorders and problems encompassing anxiety, depression, post-traumatic stress, and disruptive conduct, including the conduct problems associated with ADHD. MATCH is composed of 33 modules-i.e., specific treatment procedures derived from decades of research on EBTs. The various modules can be organized and sequenced flexibly to tailor treatment to each child's characteristics and needs.
15964580|NCT03153904|Other|Monitoring and Feedback System|For each child, the web-based MFS provides weekly monitoring of the MATCH modules used and the child's treatment response, in two forms (a) changes on the Brief Problem Monitor (BPM) and (b) changes in severity of the top treatment concerns identified by youths and caregivers. At the end of treatment, the MFS provides a complete record of modules used, and child treatment response, across all weeks of treatment.
15964581|NCT03153891|Other|Natural Environment|the natural environment will be delivered via Samsung VR gear goggles with Samsung smartphone.
15964582|NCT03153891|Other|Built Environment|the built environment will be delivered via Samsung VR gear goggles with Samsung smartphone.
15964583|NCT03153852|Drug|Modified Jessner's solution|Modified Jessner's solution will be applied on the right side until frosting
15964584|NCT03153852|Drug|Glycolic acid|Glycolic acid 70% on the other side of the face, then it will be neutralized with water after 5 minutes
15964585|NCT03153852|Drug|Trichloroacetic acid|Trichloroacetic acid 20% will be applied in one uniform coat to both sides of the face until frosting
15964586|NCT03153839|Behavioral|Aquatic physical activity in babies|"A programme based on four different types exercises realized in a swimming pool for twelve months.
~Before the beginning of the aquatic physical activity, the infants will be evaluated. Afther that, the study group will practise the exercises with their parents in 20 minutes sessions twice a week and when they finish the programme they will be evaluated again."
15964587|NCT03153826|Other|Comparison of clinical and biological characteristics of patients|Comparison of clinical and biological characteristics of patients with less variation in muscle mass (evaluated by CSARF) compared to patients with greater variation during an hospitalization for COPD exacerbation
15964588|NCT03153813|Drug|capsaicin 8% patches (Qutenza)|
15964589|NCT03153813|Other|Placebo patches|
15964590|NCT03153800|Biological|bronchial basal cells|Transplantation of autologous bronchial basal cells by fiberoptic bronchoscopy.
15964591|NCT03153787|Other|Probiotic|Vaginal probiotic administration according to the standard regimen: 1 tablet (via vaginal) for 5 days after menstruation during the same cycle of the next embryo transfer.
15964592|NCT03153774|Diagnostic Test|Assessment of sarcopenia prevalence|Handgrip test, Bioimpedance analysis (Bodystat), 6-min walking test, Short physical performance battery (balance test, 4-min walking test, 5 times getting-up test), Biological markers test, Trans-thoracic echography, Electrocardiogram 12 leads, Palm gripping test
15964593|NCT03153761|Other|CSD170201AA|A moist snuff product
15964594|NCT03153761|Other|CSD170201AB|A moist snuff product
15964595|NCT03153735|Device|CMDHA0101|Maximum injection dose : 22 ml
15964596|NCT03153735|Device|PowerFill®|Maximum injection dose : 22 ml
15964597|NCT03153722|Procedure|Pediatric discharge process interventions|"As this is an iterative quality improvement process, interventions will be evidence-based and chosen to test effectiveness for addressing areas of discharge bottlenecks or inefficiency within our specific hospital's context. Examples of possible interventions may include implementation of a discharge risk assessment (as in Statile et al, Pediatrics 2016), institution of a medications-in-hand policy on hospital discharge (as in Sauers-Ford et al, Pediatrics 2016), or initiation of a ward discharge coordinator who will help coordinate outpatient follow-up for patients. Interventions will be implemented in a stepwise fashion, utilizing successive plan-do-study-act cycles, with a minimum 2 month period between interventions to monitor outcomes."
15964598|NCT03153696|Behavioral|Cellie Coping Kit Intervention|The Cellie Coping Kit intervention is grounded in empirical evidence regarding injury recovery. By utilizing parents as coaches, the Cellie Coping intervention can be initiated in the hospital and continued as the child recovers at home. The intervention's portable, engaging design and active partnership with parents as consistently available coaches, allows families to use the intervention anywhere (i.e., home, hospital, during procedures) ensuring the child is supported at the time the injury-related stressor arises. The Cellie Coping Intervention consists of 1) a stuffed toy to promote engagement, 2) caregiver book, and 3) coping cards. Skills are presented in a way usable by most parents and children without medical team support.
15964599|NCT03153683|Other|Registry|Collect standard of care clot and arterial blood during standard of care thrombectomy from Acute Ischemic Stroke Patients for lab analysis.
15964600|NCT03153657|Drug|Piroxicam-Beta-Cyclodextrin|The patients will receive a single-dose of Piroxicam-Beta-Cyclodextrin (20 mg) thirty minutes before the bleaching procedure.
15964601|NCT03153657|Drug|Placebo|The patients will receive a single-dose of placebo with the same presentation of the experimental drug thirty minutes before the bleaching procedure.
15964602|NCT03153644|Behavioral|Interview|1 hour semi-structured
15964603|NCT03153644|Behavioral|Observation|Field Observation
15964604|NCT03153618|Other|VALIDATE system|Will be invited to interact with VALIDATE to answer questions about Family Cancer history and some personal medical and lifestyle history. Based on responses, VALIDATE will determine if they meet referral indications for cancer predisposition assessment.
15964605|NCT03153605|Other|Common toothpaste|different toothpaste
15964606|NCT03153592|Procedure|Transpulmonary pressure driven ventilation strategy|Patients will receive volume controlled ventilation set with a tidal volume at 6-8 ml/kg of ideal body weight, an inspiratory transpulmonary pressure less than 20 cmH2O, and an expiratory transpulmonary pressure (PLexp) equal or greater than 0. At PLexp increasing from 0 up to 10 cmH2O, inspired fraction of oxygen would also be increased from 40% to 100%. Respiratory rate will be set to obtain an arterial partial pressure of carbon dioxide between 35 and 45 mmHg and to ensure a physiological pH. Whenever the clinician will deem it appropriate, an alveolar recruitment maneuver as previously described
15964652|NCT03153215|Other|Placebo|Placebo tablets similar to Sildenafil will be given to control group in addition to fish oil and zinc supplementation.
15964653|NCT03153202|Drug|Ibrutinib|once daily oral intake ibrutinib
15964607|NCT03153592|Procedure|Conventional ventilation strategy|13 patients will undergo volume controlled ventilation set with a tidal volume between 6-8 ml/kg of ideal body weight, positive end-expiratory pressure and fraction of inspired oxygen set to obtain a peripheral saturation in oxygen equal or greater than 94% and a plateau pressure <28 cmH2O Respiratory rate will be set to obtain an arterial partial pressure of carbon dioxide between 35 and 45 mmHg and in any case to ensure a physiological pH. In addition, whenever the clinician will deem it appropriate, an alveolar recruitment maneuver will be performed as previously described
15964608|NCT03153579|Drug|LSD|"Lysergic Acid Diethylamide
~200ug per os, single dose"
15964609|NCT03153579|Drug|Placebo|Capsules containing mannitol looking identical to LSD
15964610|NCT03153566|Biological|tuberculin|inject the mother wart with .3 ml tuberculin vaccine every 2 weeks
15964611|NCT03153566|Device|cryotherapy|10 sec 1 cycle into all genital warts
15964612|NCT03153553|Other|Ischemic Preconditioning|Ischemic preconditioning (IPC) is an experimental technique for producing resistance to the loss of blood supply, and thus oxygen, to tissues of many types. In the heart, IPC is an intrinsic process whereby repeated short episodes of ischaemia protect the myocardium against a subsequent ischaemic insult
15964613|NCT03153553|Other|Sham Intervention|Sham intervention will be administered to the right upper limb using a manual BP cuff which will be inflated at a pressure 30mmg Hg below the diastolic blood pressure. The sham cycles comprised of three cycles of cuff inflation each lasting 5 minutes in duration followed by 5-min period of cuff deflation
15964614|NCT03153540|Device|Active iTBS|Intermittent theta burst transcranial magnetic stimulation
15964615|NCT03153540|Device|Sham iTBS|Sham intervention
15964616|NCT03153527|Drug|Prednisone|The control intervention (standard treatment) consists of prednisone treatment in decreasing doses, starting with 7.5 mg q.d. and reducing the dose every 7 days, such that prednisone treatment is stopped after a total of 4 weeks.
15964617|NCT03153527|Other|Placebo Arm|The experimental intervention consists of stopping glucocorticoid treatment abruptly and administering matching placebo over 4 weeks.
15964618|NCT03153514|Biological|Obinutuzumab|"Obinutuzumab i.v.
~[Day 0 = day of stem cell transplant]
~Cycle 1: 100 mg (d -8), 900 mg (d -7), 1000 mg (d -1, +7, +14)
~Cycle 2: 1000 mg (d +1, +8, +15, +22)"
15964619|NCT03153501|Diagnostic Test|CT-guided Abrams needle biopsy, US-guided cutting needle, medical thoracoscopy|
15964620|NCT03153488|Radiation|MRI|All participants will perform one MRI session before initiation of treatment. The imaging session will last about an hour including the structural and functional MRI portions. The subjects lie on a padded scanner couch in a dimly illuminated room, and wear foam earplugs to attenuate scanner sounds.
15964621|NCT03153475|Device|ATTUNE Revision Knee System in Revision Total Knee Arthroplasty|Implants from the ATTUNE Revision Knee System will be used to treat subjects whose surgeons have determined their existing implants need to be removed and replaced.
15964622|NCT03153462|Biological|Axicabtagene Ciloleucel|Axicabtagene Ciloleucel and A conditioning chemotherapy regimen of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously.
15964623|NCT03153449|Device|ATTUNE Revision Knee System in Total Knee Arthroplasty|Implants from the ATTUNE Revision Knee System will be used to treat subjects whose surgeons have determined their anatomy is such that the use of revision components are required to perform primary total knee arthroplasty
15964624|NCT03153436|Biological|Myoinositol|
15964625|NCT03153423|Procedure|Strabismus surgery|Recession and resection of horizontal extra ocular muscles
15964626|NCT03153410|Drug|Cyclophosphamide|"200 mg/m2 is to be administered as a 30 minute IV infusion one day prior to GVAX for a total of 8 doses.
~Other Names:
~Cytoxan CY"
15964627|NCT03153410|Drug|GVAX|"5E8 cells is to be administered one day after CY, pembrolizumab, and IMC-CS4/ LY3022855 for a total of eight doses.
~Other Names:
~Pancreatic cancer vaccine Panc 10.05 pcDNA1/GM-Neo, Panc 6.03 pcDNA1/GM-Neo"
15964628|NCT03153410|Drug|Pembrolizumab|"200 mg will be administered as a 30 minute IV infusion one day prior to the GVAX pancreas vaccine for a total of 18 doses.
~Other Names:
~MK-3475 KEYTRUDA"
15964629|NCT03153410|Drug|IMC-CS4|75 mg for dose level 1 and 100 mg at dose level 2 will be administered (Day 1, Day 8 and Day 15) as a 30 minute(s) IV infusion one day prior to GVAX pancreas vaccine for a total 18 doses.
15964630|NCT03153397|Other|Nutraflora scFOS|prebiotic fiber (Nutraflora scFOS via Vital AF)
15964631|NCT03153397|Other|Osmolite|non-prebiotic fiber containing formula (Osmolite)
15964632|NCT03153384|Procedure|Blood Culture|For each patient, one single high volume blood culture (3 aerobic and 3 anaerobic of 8 to 10 mL each, numbered), and then 2 samples of 16 to 20 mL (one aerobic bottle and one anaerobic for each sample).
15964633|NCT03153358|Drug|Icotinib|icotinib 125 milligram three times a day
15964634|NCT03153358|Radiation|SBRT|given radiation for the primary lesion
15964635|NCT03153345|Device|bedside respiratory muscle training|The program consisted of three sessions: (1) 10 minutes of breath stacking exercise, followed by (2) 10 minutes of inspiratory muscle training using a flow-oriented incentive spirometer and (3) 10 minutes of expiratory muscle training using Acapella vibratory PEP device.
15964636|NCT03153345|Behavioral|conventional stroke rehabilitation program|The program consisted of joint range of motion exercises, muscle strengthening, gait training, fine motor exercises, and activity of daily living training.
15964637|NCT03153332|Other|surgical residents' comprehension of the hepatic anatomy|Surgical residents were assigned to three different groups to evaluate different modes of patients' data. Residents were ask to state the liver segment in which the tumor resided and make a minimal resection proposal, including the tumor, the safety margin (1cm) and the dependent liver tissue. Residents were recommended to proceed in a classic way by resecting the whole liver segment. The time spent by each resident was also recorded in order to assess the quickness of comprehension and information transfer of the three different modes of presentation.
15964638|NCT03153319|Drug|Adalimumab Injection [Humira]|Investigational Drug
15964639|NCT03153319|Drug|Saline Solution for Injection|Placebo Comparator
15964640|NCT03153306|Drug|albumin|"Two groups were formed at random for each fluid. In one group, 10ml/kg of 5% albumin was given over 1 hour (the bolus group), and in the other group, the same volume was given over 6 hrs (thecontinuous group)"
15964641|NCT03153293|Drug|rAAV2-ND4|a Single IVT Injection
15964642|NCT03153280|Drug|Lithium|Dose escalation of Lithium to determine the maximum tolerated dose (MTD)
15964655|NCT03153176|Behavioral|Training|Training program 30 hours accumulated before, during and after intervention
15964656|NCT03153176|Behavioral|Individual level|7 to 10 minutes in Physical Education in class time, 3 sections for week during lunch break
15964657|NCT03153176|Behavioral|Organizational level|Inclusion of actions in the school curriculum: counseling sections with health for parents and adolescent, active lesson breaks during theoretical class, gardening experience in school, nutrition guidance for school lunch professionals.
15964658|NCT03153163|Drug|Trastuzumab Emtansine|Trastuzumab emtansine will be administered by IV infusion at a dose of 3.6 milligrams per kilogram (mg/kg) of body weight, every three weeks (Q3W) until death, disease progression or unmanageable toxicity.
15964659|NCT03153150|Drug|Apixaban|The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
15964660|NCT03153150|Drug|Rivaroxaban|The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
15964661|NCT03153150|Drug|Edoxaban|The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
15964662|NCT03153150|Drug|Dabigatran|The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
15964663|NCT03153150|Drug|Acenocoumarol|The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
15964664|NCT03153150|Drug|Phenindione|The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
15964665|NCT03153150|Drug|Warfarin|The participant will be allocated to start this oral anticoagulant drug, if the participant's doctor indicated it before randomisation.
15964666|NCT03153137|Drug|Macitentan 10 mg|film-coated tablet; oral use
15964667|NCT03153137|Drug|Placebo|film-coated tablet; oral use
15964668|NCT03153124|Other|Respiratory muscle training|The intervention group will perform three months of intradialytic training of a physical therapy protocol with PowerBreath
15964669|NCT03153111|Drug|Macitentan|macitentan 10 mg; film-coated tablet; oral use
15964670|NCT03153111|Drug|Placebo|film-coated tablet (identical to the macitentan tablet); oral use
15964671|NCT03153098|Behavioral|Active Herts|Active Herts is a community physical activity intervention aimed at inactive adults aged 16 and over who have one or more risk factors for CVD and/or a mild to moderate mental health condition. The programme uses the latest evidence-based behaviour change techniques to target physical activity, wellbeing, and key drivers of behaviour from the COM-B model of behaviour change.
15964672|NCT03153085|Biological|TBI-1401(HF10)|"1x10^7 TCID50/mL TBI-1401(HF10) (for a total of 6 injections; the first 4 injections at 1-week intervals; the remaining 2 injections at 3-week intervals).
~Following combination therapy, patients may continue to receive the 1x10^7 TCID50/mL TBI-1401(HF10) alone for up to an additional 13 injections (total of 19 injections = 1 year) if eligible for administration."
15964673|NCT03153085|Drug|Ipilimumab|3 mg/kg ipilimumab (for a total of 4 intravenous infusions, each administered at 3-week intervals).
15964674|NCT03153072|Biological|Assess the absorption of oral amiodarone|Evaluate the pharmacokinetics of oral amiodarone solution at 15 mg / mL after oral administration
15964675|NCT03153059|Other|Stool frequency|This study is just observational study.
15964676|NCT03153046|Dietary Supplement|prebiotics|Bimuno (BGOS): The active supplement of the food supplement (Bimuno) used in this study is called galacto-oliogosaccharides (Bimuno®, BGOS). BGOS is a compound metabolised by specific bifidobacteria, which are beneficial bacteria, in our colon. Bimuno (2.3 calories) is composed by the following ingredients per gram of Bimuno: 0.96g dry matter; <01g Fat; <0.06g Protein; 0.821g GOS; 0.119g Lactose; 0.0331g Glucose and 0.0029g Galactose. Bimuno is tasteless. Bimuno will be supplied in coded sachets (3.5g) for dispensing by parents. Each participant will be required to consume 1 sachet daily during breakfast, by mixing it with food or in a drink.
15964677|NCT03153046|Dietary Supplement|Maltodextrin|Maltodextrin is a polysaccharide in powder form, which grows most bacteria in the gut, and not specifically the beneficial bifidobacteria. The placebo will also be provided in daily coded sachets (3.5g) for dispensing by parents. Each participant will be required to consume 1 sachet daily during breakfast, by mixing it with food or in a drink. This placebo has been used in previous studies, in which Bimuno was used as the active intervention. The placebo will be similar in taste and colour to the active intervention.
15964678|NCT03153033|Behavioral|Fatigue protocol|The figure 8 protocol (fatigue intervention) requires the participants to propel three times as many laps as possible for four minutes each with their wheelchair. The protocol has been developed and used previously. Every bout of four minutes is separated by 90 seconds of rest. Each lap consists of a right and left turn and two complete stops after half a lap. Measurements during the protocol include the Rate of Perceived Exertion (RPE) scale, heart rate, and propulsion kinetics.
15964679|NCT03153020|Other|Patients with stroke or transient ischemic attack|Determination of factors associated to the conformity to secondary prevention treatment 1, 2 and 3 years post a stroke or transient ischemic attack.
15964680|NCT03152994|Other|Checking fasting blood glucose(FBG)|This is an observational study,fasting blood glucose(FBG) of each patient will be checked every six months.
15964681|NCT03152981|Drug|Desflurane|In desflurane group, desflurane 6-8 vol% and remifentanil (target controlled infusion 2-3 ng / ml) are used for maintenance of anesthesia during surgical procedure. In propofol group, propofol 3-4 ug/ml and remifentanil 2-3 n /ml using target Controlled Infusion are used for maintenance of anesthesia during surgical procedure
15964682|NCT03152981|Drug|propofol|In desflurane group, desflurane 6-8 vol% and remifentanil (target controlled infusion 2-3 ng / ml) are used for maintenance of anesthesia during surgical procedure. In propofol group, propofol 3-4 ug/ml and remifentanil 2-3 n /ml using target Controlled Infusion are used for maintenance of anesthesia during surgical procedure
15964683|NCT03152981|Drug|remifentanil|In desflurane group, desflurane 6-8 vol% and remifentanil (target controlled infusion 2-3 ng / ml) are used for maintenance of anesthesia during surgical procedure. In propofol group, propofol 3-4 ug/ml and remifentanil 2-3 n /ml using target Controlled Infusion are used for maintenance of anesthesia during surgical procedure
15964684|NCT03152955|Drug|Ketamine|Ketamine will be applied in patient-controlled analgesia.
15964779|NCT03152175|Drug|Placebo|1mg / kg of matched placebo, oral capsule
15964685|NCT03152955|Other|scalp nerve block|Scalp nerve block is performed for the blockade of the greater occipital, superficial cervical and lesser occipital nerves with 0.5% ropivacaine.
15964686|NCT03152955|Drug|ondansetron|Ondansetron(13ug/kg/h) is applied in patient-controlled analgesia.
15964687|NCT03152955|Drug|Sufentanil|Sufentanil(0.02ug/kg/h) is applied in patient-controlled analgesia.
15964688|NCT03152942|Drug|Progesterone|Progesterone 400mg to be administered once daily for 34 weeks in the patients randomised to receive progesterone alone
15964689|NCT03152942|Drug|Aminophylline|Patients randomised to the combination arm to be administered aminophylline 225 mg to be taken once at night for 1 week and then if tolerated increased to 225 mg twice daily Progesterone 400mg to be administered once daily for 34 weeks.
15964690|NCT03152929|Drug|Paravertebral Block|20-30 mL 0.5% Ropivacaine
15964691|NCT03152929|Drug|Pectoral Nerve Block|20-30 mL 0.5% Ropivacaine
15964692|NCT03152916|Device|3d printing personalized plate|3d printing personalized plate will be used in the subtalar arthrodensis
15964693|NCT03152903|Biological|VPM1002 (Recombinant BCG Vaccine)|"VPM1002 is a formulated, lyophilized cake of live recombinant Mycobacterium bovis rBCGÄureC::Hly+; VPM1002.
~VPM1002 is the active pharmaceutical ingredient. It is a genetically modified BCG vaccine derived from the Mycobacterium bovis BCG subtype Prague characterized as rBCGÄureC::Hly+. Single dose of VPM1002 is administered intradermally."
15964694|NCT03152903|Other|Placebo|Single dose of Placebo is administered intradermally.
15964695|NCT03152890|Drug|Insulin|If blood glucose level after reperfusion of liver graft exceeds 180 mg/dL, the insulin dose proposed by the linear mixed effects analysis is given as a bolus.
15964696|NCT03152877|Drug|Bupivacaine Liposome Injectable Product|20cc of liposomal bupivacaine will be injected into the vaginal/perineal laceration site, once, following completion of the surgical repair.
15964697|NCT03152877|Drug|0.25% plain bupivacaine|20cc of 0.25% plain bupivacaine will be injected into the vaginal/perineal laceration site, once, following completion of the surgical repair.
15964698|NCT03152864|Behavioral|Full Package|Individuals will be randomly allocated to receive the full HealthRhythms package (Rhythm Sensing, Rhythm Trending, and Rhythm Stabilization) program on their smartphones
15964699|NCT03152851|Procedure|Pressure stimulus group|
15964700|NCT03152838|Genetic|DNA methylation and Real-time Polymerase Chain Reaction Analysis|"Fasting blood samples will be collected from both autism and controls for DNA extraction. Peripheral blood (2ml) will be drawn from the cubital vein intoplastic syringes. Lymphocytes will be isolated from blood samples. We will examine the gene methylation in the peripheral blood lymphocytes of drug-naı¨ve autism patients and control subjects.
~DNA will be isolated from lymphocytes, purified and processed for bisulfate modification. Bisulfate treatment of genomic DNA will be performed using DNA methylation kit according to the manufacturer´ instructions. Bisulfite treatment of genomic DNA converts cytosine to uracil, but leaves methylated 5'Cytosines unchanged. Quantitative real time Polymerase chain reaction will be used to determine the DNA methylation status of the Brian derived neurotrophic factor and glia fibrillary acidic protein genes using primers specific to the human genes."
15964701|NCT03152838|Diagnostic Test|Gilliam Autism Rating Scale Arabic version|"An assessment of the severity of autism using the Gilliam autism rating scale Arabic version: This test was used for diagnosis and assessment of the severity of autistic features for ages 3-22 years. It consists of 56 items, subdivided into 4 subscales: communication, social interaction, stereotyped behaviors, development and total score. The Arabic version has been validated with good reliability and validity and used in many studies before. The lower the scores are, the worse the condition is.
~The scale will be done by trained and certified psychologist. The protocol and informed consent for this study will be reviewed and approved by the ethics committee at the Faculty of Medicine, Assiut University, Egypt."
15964702|NCT03152825|Procedure|PCI|percutaneous coronary intervention attempt
15964703|NCT03152812|Procedure|plantar surface reconstruction by free flaps|use of free skin or free muscle flaps for reconstruction of plantar surface
15964704|NCT03152799|Procedure|RIPC Remote Ischaemic Pre-Conditioning|intermittent limb ischaemia via a peripheral blood pressure cuff inflation and deflation
15964705|NCT03152799|Other|Sham Control|intermittent peripheral blood pressure cuff inflation and deflation which does not induce a protective cellular response
15964706|NCT03152786|Other|Laboratory Biomarker Analysis|Correlative studies
15964707|NCT03152786|Drug|Propranolol Hydrochloride|Given PO
15964708|NCT03152786|Other|Questionnaire Administration|Ancillary studies
15964709|NCT03152786|Other|Survey Administration|Ancillary studies
15964711|NCT03152747|Device|ultrasound, b-scan|Some selected centres will participate in a substudy. In the substudy population, if the vitreous cortex is not visible on OCT both in the study eye and the fellow eye, or if the OCT is of poor quality and most likely will not allow definite diagnosis, a B-scan ophthalmic ultrasound will be performed by an experienced examiner. The presence or absence of a PVD in the ultrasound measurement will be recorded in the case report form (CRF). If ultrasonography was not performed, allocation to the groups is based on the staging of the reading centre. Otherwise ultrasonography will be used for final diagnosis and group allocation if the reading centre classifies the OCT as not decisive.
15964712|NCT03152734|Procedure|Surgical or non-surgical intervention|Each kind of surgical or non-surgical intervention with anesthesia applied by an anesthetist
15964713|NCT03152721|Device|Parkinson KinetiGraph|The Parkinson Kinetigraph (PKG) is a wrist-worn accelerometer shaped as a watch. It records spontaneous movements and for every two minutes provides a bradykinesia score and a dyskinesia score. Furthermore it analysis movement for tremor-like episodes and registers the time with tremulous movements as well as time with extreme immobility suggesting sleep. The device can be programmed with drug intake times and provide a reminder signal. Intake of drug can be indicated on the device.
15964714|NCT03152721|Other|Self assessment|Administration of self assessment questionnaires are made within 2 weeks from starting a PKG recording. The assessments are Parkinson Disease Quality of life 8 question short version and the Non Motor Symptom in Parkinson Disease Questionnaire.
15964715|NCT03152695|Device|High-intensity focused ultrasound|Local tumor ablation by ArcBlate (EpiSonica, Taiwan) will be performed, and the entire procedure will be monitored by MRI
15964716|NCT03152682|Dietary Supplement|GoodIdea|Active product. Amount: 355mL. Consumed at a clinic visit over 14 minutes.
15964717|NCT03152682|Other|Placebo|Non-active placebo product. Amount: 355mL. Consumed at a clinic visit over 14 minutes.
15964718|NCT03152643|Procedure|blastocyst-stage embryo transfer|All the participants will receive a long GnRH-agonist, ultra-long GnRH-agonist, short GnRH-agonist or GnRH antagonist protocol in combination with recombinant FSH. HCG will be administered for final oocyte maturation. Patients will have a single blastocyst-stage embryos transferred. The outcomes of all the embryo transfers within 1 year after randomization will be followed up. Single embryo transfer (SET) is required for the first 3 embryo transfers within 1 year after randomization. For embryo transfers beyond the third within the 1 year, patients' treatment must follow their randomized allocation, and SET is no longer mandatory. Luteal phase support will be administered before embryo transfer. If pregnancy is confirmed, luteal phase support will be continued until 10 weeks of gestation. The follow up will be continued until 6 weeks after delivery.
15964719|NCT03152643|Procedure|cleavage-stage embryo transfer|All the participants will receive a long GnRH-agonist, ultra-long GnRH-agonist, short GnRH-agonist or GnRH antagonist protocol in combination with recombinant FSH. HCG will be administered for final oocyte maturation. Patients will have a single cleavage-stage embryos transferred. The outcomes of all the embryo transfers within 1 year after randomization will be followed up. Single embryo transfer (SET) is required for the first 3 embryo transfers within 1 year after randomization. For embryo transfers beyond the third within the 1 year, patients' treatment must follow their randomized allocation, and SET is no longer mandatory. Luteal phase support will be administered before embryo transfer. If pregnancy is confirmed, luteal phase support will be continued until 10 weeks of gestation. The follow up will be continued until 6 weeks after delivery.
15964720|NCT03152591|Drug|LIK066|LIK066 tablets for oral administration
15964721|NCT03152591|Drug|Placebo|Placebo tablets matching LIK066 tablets, for oral administration
15964722|NCT03152578|Other|BetaC + Capsaicin Topical Cream|BetaC + Capsacin Topical Cream applied to painful knee area 3 times per day.
15964723|NCT03152578|Other|BetaC Topical Cream|BetaC Topical Cream Cream applied to painful knee area 3 times per day.
15964724|NCT03152578|Other|Placebo Topical Cream|Placebo Cream applied to painful knee area 3 times per day.
15964725|NCT03152565|Drug|Avelumab|"Autologous Dendritic Cells vaccine: A dose of ADC at days 1, 14, 28, 42 and 56 (total of 5 doses), and thereafter every 6 months until disease progression (maximum of 6 additional doses) or unacceptable toxicity.
~Avelumab will be administered intravenously at a dose of 10 mg per kilogram of body weight, every 14 days until disease progression or unacceptable toxicity."
15964726|NCT03152552|Drug|LIK066|LIK066 was supplied in different doses as tablets taken orally.
15964727|NCT03152552|Drug|Placebo|Placebo was supplied as tablets and capsules taken orally.
15964728|NCT03152552|Drug|Empagliflozin|Empagliflozin was supplied as capsules taken orally.
15964732|NCT03152526|Device|Interventions|CliniMACS® CD3 and CD19 Reagent System
15964733|NCT03152500|Device|FEMTIS 313G IOL|Haptic design that enclaves the capsulorrhexis
15964734|NCT03152500|Device|Acrysof SN60WF IOL|IOL in the bag
15964735|NCT03152487|Other|Celiac Plexus Neurolysis|This intervention involves accessing the Celiac Plexus Nerve via endoscopic guided ultrasound and then injecting the nerve bundle with bupivacaine.
15964736|NCT03152487|Other|Radiofrequency Ablation|Radiofrequency ablation is performed via the probe for 90 seconds, followed by a 90 second rest. This is repeated until the entire ganglion becomes hyperechoic on EUS.
15964737|NCT03152474|Drug|Solumedrol 20mg|Dosed Intravenous every 8 hrs.
15964738|NCT03152474|Drug|Vitamin A 100,000 IU|Dosed Intramuscular once daily
15964739|NCT03152474|Other|Placebo|Placebo dosed intravenous every 8 hrs. or Intramuscular once daily.
15964740|NCT03152461|Diagnostic Test|Quantra System|Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
15964741|NCT03152448|Behavioral|Prolaris|Series of three questionnaires to capture treatment decisions based upon standard clinical-pathological information with the addition of Prolaris genomic testing result
15964742|NCT03152435|Biological|EGFR CART|EGFR CART cells will be administered using a split dose on day0 (10%),1(30%), and 2(60%).
15964743|NCT03152422|Diagnostic Test|Urinary proteomics|Urinary proteomics for risk stratification and graft monitoring in recipients of a heart transplant
15964744|NCT03152409|Drug|Aspirin 325mg|Participants will take intervention drug dose once a day in combination with their existing antidepressant treatment regimen.
15964745|NCT03152409|Drug|Placebo Oral Tablet|Participants will take a placebo tablet of the same size, shape, and color as the aspirin tablet.
15964746|NCT03152396|Other|CV risk assessment and modification of global risk|Individualized CV risk assessment using the validated RxEACH CV risk calculator for baseline and subsequent risk assessment. Pharmacists will assist patient's to decrease CV risk over 6 months thru education, medication modification, and monthly follow-up.
15964747|NCT03152383|Behavioral|Training trials|"A highly preferred edible item will be selected to teach the contingencies for the assessment. Materials to engage in the work response (i.e., button press) will be placed within arm's reach of the child, and the edible item will be in sight. The therapist will deliver a vocal prompt for the child to engage in the work response (e.g., press the button and you can have some candy). If the child engages in the response, the therapist immediately delivers the edible item. The therapist will guide the child to engage in the instrumental response, and will then gradually begin to fade the prompt level. If the child makes an error at any level of prompting, the therapist will guide the participant to emit a correct response. The edible item will be delivered to the child each time that the child responds correctly at any prompt level."
15964780|NCT03152162|Device|iTotal PS KRS|Total knee arthroplasty for treatment of osteoarthritis
15964781|NCT03152149|Drug|Tiotropium & olodaterol|Spiolto Respimat (Tiotropium 2.5 micrograms,olodaterol 2.5 micrograms) 2 puffs once daily for 6 months
15964782|NCT03152149|Drug|fluticasone furoate & vilanterol|Relvar Ellipta (fluticasone furoate 92 micrograms, vilanterol 22 micrograms) 1 puff once per day for 6 months
15964748|NCT03152383|Behavioral|Progressive Ratio Session|The child will be guided to engage in the instrumental response then the stimulus will be immediately delivered for 30 seconds. The leisure item or the individual who will provide attention will be directly outside of the session room. If the child emits the work response, they will be allowed access to either a leisure item or to attention (depending on the condition) for 30 seconds. The child is initially required to respond one time, then they will be required to respond two times to gain access to the item or attention (then 4, then 8, and so on) such that the response requirement progressively increases according to a pre-determined schedule. A minimum of 3 sessions will be conducted for each condition. The amount of time required for participation depends on the child's responding, and caregiver availability. Participation may take as little as a couple hours, or as long as 3-4 hours per day for approximately one week.
15964749|NCT03152383|Behavioral|Re-test|10 children with ASD will return to repeat the progressive ratio (PR) assessment one week after completing it the first time to examine the reliability of the measure.
15964750|NCT03152383|Behavioral|Pairing Protocol|15 children with ASD will receive an intervention designed to increase social approach after completing the PR assessment. Participants will attend 2 hour appointments 3-5 days per week in which a therapist will deliver highly preferred items, play with the child, work on teaching communication skills, and teach the child to comply with demands. After completing the intervention (once the child is willingly staying near and interacting with the therapist and complying with instructions), the PR assessment will be repeated to measure change due to the intervention.
15964751|NCT03152370|Drug|E7046|oral administration
15964752|NCT03152370|Radiation|Long Course Chemoradiotherapy (LCRT)|pelvic radiotherapy
15964753|NCT03152370|Radiation|Short Course Radiotherapy (SCRT)|pelvic radiotherapy
15964754|NCT03152370|Drug|capecitabine|chemotherapy
15964755|NCT03152370|Drug|folinic acid/5-FU/oxaliplatin (mFOLFOX-6)|chemotherapy
15964756|NCT03152357|Device|ConforMIS iUni, iDuo, or iTotal (CR)|ConforMIS iUni, iDuo, or iTotal (CR)
15964757|NCT03152344|Procedure|Timed Up and Go|It's a functional test evaluating the time to rise from a chair, walk 3 meters, turn around, walk back to the chair and sit down (abnormal cut-off value >12 seconds).
15964758|NCT03152331|Behavioral|Receptive Awareness Training|Two 12-minute learning sessions will be conducted for each learning day. Separate instructions will be provided before session 1 and before session 2 to facilitate receptive awareness. The participant is seated in front of a BIS monitor and learns that the BIS number will decrease when in a state of receptive awareness. The trainee will learn to use attentional flexibility in daily activities and adopt willful attention (focal concentration) alternatively with receptive awareness (relaxed attention), as a situation dictates.
15964759|NCT03152318|Drug|rQNestin|rQNestin is an oncolytic viral vector. It is administered via intratumoral injection during biopsy surgery.
15964760|NCT03152318|Drug|Cyclophosphamide|Cyclophosphamide is an immunomodulating agent. It is administered intravenously in a single dose 2 days (+/- 6 hrs) before surgery.
15964761|NCT03152318|Procedure|Stereotactic biopsy|In both arms, subjects will undergo standard of care stereotactic biopsy in the intraoperative MRI operating room. The stereotactic needle will be placed stereotactically into the tumor bed using intraoperative MRI guidance to collect the biopsy, and again to administer the rQNestin oncolytic virus.
15964762|NCT03152305|Other|Intracranial pressure variations|Self-measure of ICP will be performed outside and during menstrual migraine attacks.
15964763|NCT03152292|Other|Real-world, non-interventional|N/A - non-interventional
15964764|NCT03152279|Diagnostic Test|Mucosal Impedance Catheter|During routine endoscopy, consented study participants will have a mucosal impedance catheter sensor positioned along the mucosal wall to measure resistance across the mucosa. The study procedure will add approximately 1-2 minutes of anesthesia time for each participant.
15964765|NCT03152279|Diagnostic Test|Blood sample|At time of endoscopy, subjects with initial positive CeD serology will have a blood sample taken for any missing CeD serologies and intestinal fatty acid-binding protein (IFABP). This will be done at time of IV initiation as to avoid any additional venipuncture.
15964766|NCT03152266|Other|No intervention. Observational study|Follow up of the function of the hip after reduction of the impacted fragment which associated with acetabular fractures
15964767|NCT03152253|Behavioral|Text My Quit (TMQ)|Text messages designed to aid smoking cessation
15964768|NCT03152253|Behavioral|Peer Support|A group chat room for peer support
15964769|NCT03152253|Other|Motivational Messages|Generic motivational messages not related to smoking cessation
15964770|NCT03152240|Other|Non intervention|Non intervention
15964771|NCT03152227|Other|ACGG|50 high-producing chicks to households along with provision of technical input on production
15964772|NCT03152227|Behavioral|BCC|Nutrition sensitive BCC on poultry-specific aspects of nutrition, WASH, women's empowerment, and use of income combined with home gardening.
15964773|NCT03152214|Other|Vigorous Intensity Aerobic Exercise and Community Engagement|"Each veteran will be provided with an Apple watch for the duration of the study. Research staff will use the resultant data to monitor the veteran's activity level. Veterans will be asked to complete three 25-minute sessions of vigorous intensity aerobic exercise per week (either running, cycling, rowing, or elliptical workouts). Data collected will include the number of minutes exercised and the heartrate level (77-85% maximum heart rate). Any exercise session of 25 minutes at > 76% of maximum heart rate will be characterized as 1 completed session of vigorous-intensity exercise. Veterans will enter the activity, minutes exercised, average heartrate, and perceived exertion into REDCap.
~Community engagement will involve attending at least one Team RWB event per week through the Austin or Killeen chapters. This could be a weekly running group, hike, or community service project-among other activities. Veterans will enter whether or not they attended a Team RWB event on REDCap."
15964774|NCT03152214|Other|Community Engagement|Veterans in the study will receive a monthly calendar of Team RWB events upon assignment. Veterans will be able to participate in any Team RWB event located in Austin or Killeen. Veterans will be asked to attend at least one Team RWB event. This could be a weekly running group, hike, or community service project- among other activities. Veterans will enter whether or not they attended a Team RWB event on the REDCap exercise adherence surveys.
15964775|NCT03152201|Diagnostic Test|electrophysiological signal|trasmit the electrophysiological signals to the neurosurgeon through the hardware
15964776|NCT03152188|Drug|FMT|Fifteen FMT Openbiome capsules administered at the same time
15964783|NCT03152136|Device|Cala ONE device|The Cala ONE device is a wrist-worn stimulator which applies a tremor-customized stimulation pattern to an individual's nerves.
15964784|NCT03152123|Drug|Pitolisant|Pitolisant 40 mg or 240 mg (tablets over-capsuled)
15964785|NCT03152123|Drug|Placebos|tablets over-capsuled
15964786|NCT03152123|Drug|Phentermine|Phentermine 60 mg (capsule over-capsuled)
15964787|NCT03152110|Other|HIIT|"A handcycle or tabletop ergometer will be used for HIIT. Exercise sessions will be scheduled 3x/week for 6 weeks (2 sessions supervised, 1 session unsupervised). The HIIT goal is to achieve 10 sets of 60 second bouts of arm cycling at 90% of their PPO with 60 seconds of active recovery.
~Supervised exercise sessions: Measures include HR, BP, RPEs, Feeling Scale, and PPO. After warming up, individualized work/rest phases will be prescribed based on their PPO from their maximal aerobic test. Participants will be held at 90% PPO as a constant target intensity to start, shortening the work phase, and if necessary, lengthening the recovery phase. These parameters will be progressed each session. The trainer will determine when to change their work/rest parameters based off of HR and RPEs.
~Unsupervised exercise sessions: Participants will repeat the same HIIT protocol they performed during the previous supervised session. The bike computer automatically stores HR and PPO."
15964788|NCT03152097|Dietary Supplement|Commercially available Diindolylmethane|Commercially available Diindolylmethane is a compound derived from cruciferous vegetables (e.g. broccoli)
15964789|NCT03152097|Other|Placebo|A matching placebo capsule will be compounded by the UPMC Investigational Drug Service
15964790|NCT03152084|Drug|Dapagliflozin|The study consists of a 2-week, open label, dapagliflozin (10mg) treatment period.
15964791|NCT03152071|Procedure|Robot assited thoracic surgery|The lobectomy will be preformed in case of an operable lung cancer. The thoracic surgery technique used is robot assisted thoracic surgery
15964792|NCT03152071|Procedure|Video assited thoracic surgery|The lobectomy will be preformed in case of an operable lung cancer. The thoracic surgery technique used is video assisted thoracic surgery.
15964793|NCT03152058|Drug|Certolizumab Pegol|"Certolizumab [400 mg (given as two subcutaneous injections of 200mg) initially and 2 and 4 weeks later, followed by 200 mg every other week thereafter] The 1st dose of certolizumab will be administered by 8 weeks and 6 days gestation and discontinued at 27 weeks 6 days.
~The regimen of heparin and low dose aspirin is a standard of care treatment for this patient population and is not considered part of the research intervention."
15964794|NCT03152045|Behavioral|Communication Intervention|In this study, Investigators are testing the feasibility, acceptability, and preliminary efficacy of a systems intervention that asks adolescents to report their risk behaviors before their encounter. Both clinicians and patients will receive a Feedback Guide that gives them tips on effective ways to communicate about these behaviors.
15964795|NCT03152032|Behavioral|In-House Vocational Training Programs|At the beginning of the IHVT programs, the job placement for each participant was determined jointly by the participant's interest, the demands of local job markets and the team evaluation. The programs covered 6 to 10 months in length, 5 days a week and 4 to 6 hours a day. The programs contained three sessions: (a) the work-related behavior training session, such as proper appearance, communication and self assertion, and workplace social skills, (b) the on-the-job skill training session where participants gained job-specific training and interventions from job coaches and occupational therapists, and (c) the life balance counseling session including individual and group counseling that aimed to enhance the participants' ability to tackle potential hardships and barriers to work.
15964796|NCT03152019|Drug|Protopic® (Tacrolimus) 0.1% ointment|About 0,1g of ointment is administered by the patient on nasal mucosa of each nostril twice a day for 6 weeks.
15964797|NCT03152019|Drug|Placebo|About 0,1g of ointment is administered by the patient on nasal mucosa of each nostril twice a day for 6 weeks.
15964798|NCT03152006|Other|ACT|Coordinated, graduated transition which includes an early introduction to the adult clinician during the PAPA pre-transfer period, a peer-facilitated organized support group aimed at improving transition readiness and addressing critical psychosocial skills including self-efficacy and locus of control and a case management team including a patient advocate who coordinates the transfer between pediatric and adult care teams.
15964799|NCT03151993|Drug|Recombinant staphylokinase|10 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds
15964800|NCT03151993|Drug|Alteplase|Intravenous alteplase 0.9 mg/kg (10% bolus and 90% as IV infusion over 1 hour, maximum 90 mg)
15964801|NCT03151980|Procedure|Hamam treated skin and sun exposure|Hamam is a skin treatment (soaping and scrubbing).
15964802|NCT03151980|Other|Untreated skin and sun exposure|Skin that will not receive Hamam.
15964803|NCT03151967|Drug|Lactobacillus crispatus CTV-05|vaginal applicator with medium containing drug
15964804|NCT03151967|Drug|Placebo|vaginal applicator with medium containing no drug
15964805|NCT03151954|Procedure|functional endonasal sinus surgery|collect nasal polyps from patients
15964806|NCT03151954|Procedure|nasal septal construction|collect inferior turbinates from patients as control arm
15964807|NCT03151928|Diagnostic Test|BDMax Vaginal Panel|The tests will be used to compare results between clinician diagnosis/routine care testing and the above interventions
15964808|NCT03151889|Device|TENS|TENS Group: Pre-test evaluations (Clinic Conditions; Live Quality; Salivary Flux); TENS treatments (50Hz / pulse duration of 250 ms / high intensities tolerated / continuously for 20 minutes / 2 sessions a week / 4 weeks / total of the 8 TENS sessions) and Post-test evaluations.
15964809|NCT03151876|Drug|Chidamide|30 mg oral twice weekly for 2 weeks
15964810|NCT03151876|Drug|Cladribine|6 mg/m2 intravenously daily for 5 days
15964811|NCT03151876|Drug|gemcitabine|2500 mg/m2 intravenously twice weekly for 1 week
15964812|NCT03151876|Drug|Busulfan|3.2 mg/kg intravenously daily for 4 days
15964813|NCT03151876|Procedure|Autologous hematopoietic stem cell transplantation|autologous hematopoietic stem cells infusion after ChiCGB chemotherapy
15964814|NCT03151863|Drug|Opioids|The usual opioid treatment used for nursing care
15964815|NCT03151863|Drug|Dexmedetomidine|Dexmedetomidine is provided intranasally
15964816|NCT03151863|Drug|Placebo|Normal saline is either given subcutaneously or intranasally
15964817|NCT03151850|Other|ulcerative colitis|We take 2 pieces of biopsies in the sigmoid colon mucosa inflammation area during the colonoscopy and then perform gene sequencing.
15965672|NCT03145168|Other|Low Target Mean Arterial Pressure|Low target MAP group (60-65mm Hg).
15964818|NCT03151850|Other|Control|We take 2 pieces of biopsies in the sigmoid colon mucosa during the colonoscopy and then perform gene sequencing.
15964819|NCT03151837|Dietary Supplement|Greenyn Momordica charantia extracts|Extracts from Momordica charantia containing Momordica charantia insulin receptor binding protein (mcIRBP)
15964820|NCT03151837|Dietary Supplement|Placebo control|Starch
15964821|NCT03151824|Other|quality of life|Quality of life which was measured by the Korean version of the 36-item short-form health survey (SF-36)
15964828|NCT03151785|Other|Face-to-face BLS training|Pupils will receive CPR training by standardised face-to-face BLS training only
15964829|NCT03151785|Other|Lifesaver training|Pupils will receive CPR training by Lifesaver programme only
15964830|NCT03151785|Other|Lifesaver and Face-to-Face BLS training|Pupils will receive CPR training by Lifesaver and standardised face-to-face BLS training
15964831|NCT03151772|Drug|Disulfiram|200 mg disulfiram two times daily and 2,5 mg copper once daily taken preoperatively
15964832|NCT03151772|Drug|Metformin|Metformin 850 mg x 3 taken preoperatively
15964833|NCT03151759|Radiation|Neoadjuvant radiotherapy|Neoadjuvant radiotherapy prior to rectal cancer surgery
15964834|NCT03151746|Drug|Placebo|Placebo pill administered orally 1 hour before planned surgical procedure
15964835|NCT03151746|Drug|Gabapentin|Gabapentin pill (1200mg) administered orally 1 hour before planned surgical procedure
15964836|NCT03151733|Procedure|single incision laparoscopic surgery|Patients undergo single incision laparoscopic surgery
15964837|NCT03151733|Procedure|conventional laparoscopic surgery|Patients undergo conventional laparoscopic surgery
15964838|NCT03151720|Drug|loratadine (Xisimin [Test Treatment])|Participants will receive 10 mg loratadine as Xisimin (test treatment) as per the treatment sequence.
15964839|NCT03151720|Drug|loratadine (Clarityne [Reference Treatment])|Participants will receive 10 mg loratadine as Clarityne (reference treatment) as per the treatment sequence.
15964840|NCT03151707|Drug|Nicotinamide Riboside|Nicotinamide riboside 2g/day
15964841|NCT03151681|Drug|Propranolol Pill|1mg/kg of propranolol 60 minutes prior to memory reactivation
15964842|NCT03151668|Drug|Dexmedetomidine|
15964843|NCT03151655|Behavioral|MATTeRS Video|Narrative-based video intervention and accompanying workbook
15964844|NCT03151655|Behavioral|Didactic Video|Education only video
15964845|NCT03151642|Radiation|Chemotherapy|Patients will have their chemotherapy coordinated through the Medical Oncology department at the University of Pennsylvania, and will be followed by Medical Oncology at Penn during chemoradiation. As part of the standard of care for locally advanced esophageal cancer, neoadjuvant concurrent chemotherapy will likely consist of weekly carboplatin and paclitaxel, beginning within 1 day of starting radiation therapy and continuing until the completion of radiation treatment. Alternative chemotherapy regimens, dose adjustments or delays in administration will be determined at the discretion of the treating medical oncologist and recorded in the patient's chart.
15964846|NCT03151642|Radiation|Radiation Therapy|Patients will have their radiation therapy coordinated and performed through the Radiation Oncology Department at the University of Pennsylvania. The development and delivery of the patient's radiation treatment plan will be at the discretion of the treating radiation oncologist, and details will be recorded in the patient's chart.
15964847|NCT03151642|Procedure|Surgery|Patients will have their surgery coordinated and performed through Thoracic Surgery department at the University of Pennsylvania. Patients will undergo esophagectomy 4-8 weeks after the completion of neoadjuvant chemoradiation as part of the standard of care.
15964848|NCT03151642|Device|MRI Imaging|A total of 40 paired MRI examinations from eligible participants will be collected in the Department of Radiology at the Hospital of the University of Pennsylvania. Participants will undergo two 1.5T MRI studies performed at two time points: (1) within 28 days prior to starting neoadjuvant chemoradiation, and (2) between radiation fraction 8-13 during treatment. The quantitative imaging studies for the trial (DWI) will be performed with and without respiratory gating using a navigator, with B values of 0, 100, 600 and 800 s/mm2.
15964849|NCT03151642|Other|Blood Draws|The procedure of blood collection for each patient will be as follows: the total amount being drawn each time will be approximately 30 cc. Approximately 25 ml of blood will be collected into heparinized tubes, and immediately placed on ice in a prepared plastic bag and transported to the laboratory for processing within 1 hour. If necessary, we may need up to 2 hours in order to begin processing the blood; in the event that longer than this time period has transpired, the sample will be deemed inadequate for processing purposes. The first blood draw will be obtained prior to the first fraction of radiation treatment and will be coordinated to occur at the time of pre-treatment MRI. Thereafter, the second sample will be obtained during chemoradiation therapy, between fraction 8-13 and the blood draw will be coordinated with the on-treatment MRI scan.
15964850|NCT03151629|Other|Standard of Care|Drugs routinely administered for metastatic prostate cancer per local standard.
15964851|NCT03151616|Other|anticholinergic risk scale|Risk summation scale for grading and studying anticholinergic medication exposure
15964852|NCT03151603|Drug|Arctuvan|application of a herbal drug
15964853|NCT03151603|Drug|Fosfomycin|application of an antibiotic drug
15964854|NCT03151603|Drug|Placebo to Arctuvan|application of Placebo to Arctuvan
15964855|NCT03151603|Drug|Placebo to Fosfomycin|application of Placebo to Fosfomycin
15964856|NCT03151590|Behavioral|exercise training|
15964857|NCT03151577|Procedure|XEN® Gel Stent implantation|Minimally invasive glaucoma surgery (MIGS) which consists of implanting a XEN® Gel Stent in the irido-corneal angle of the eye to drain the aqueous humour in the sub-conjunctival space to lower the IOP.
15964968|NCT03150758|Device|7Hz + 200 micro-seconds|7Hz Electrical Stimulation with a pulse width of 200 micro-seconds
15964858|NCT03151564|Diagnostic Test|Computed Tomography Scan - 50% Dose Reduction|Participants undergo routine standard of care CT examination for colon carcinoma restaging, then have an additional scan of the liver at 50% dose reduction.
15964859|NCT03151564|Diagnostic Test|Computed Tomography Scan - 70% Dose Reduction|Participants undergo routine standard of care CT examination for colon carcinoma restaging, then have an additional scan of the liver at 70% dose reduction.
15964860|NCT03151551|Drug|Ixekizumab|Administered SC
15964861|NCT03151551|Drug|Adalimumab|Administered SC
15964862|NCT03151538|Behavioral|Exercise Training Mixed With Play|To assess effects of training program which includes mixed exercises with playing.Study included 90 pre-school children who suffer from pes planus and increased femoral anteversion angle. Demographic data, navicular height, weight-bearing and non-weight bearing of subtalar joint motion, metatarsal width(weight and non-weight), range of hallux valgus,height of foot, tension of Achilles tendon, habits of W standing(hour/day), angle of Quadriceps(Q degree), angle of hip rotation were recorded . Craig Test, foot posture index, Chippaux-Smirak Index(CSI),Beighton hypermobility score, valgus index, thigh foot angle examination were used. CSI measurements were positive correlation with severity of pes planus.
15964863|NCT03151538|Other|Controlled|First and last measurements will be done. There will be no intervention. Study will include 30 healthy pre-school children. Demographic data, navicular height, weight-bearing and non-weight bearing of subtalar joint motion, metatarsal width(weight and non-weight), range of hallux valgus,height of foot, tension of Achilles tendon, habits of W standing(hour/day), angle of Quadriceps(Q degree), angle of hip rotation were recorded . Craig Test, foot posture index, Chippaux-Smirak index(CSI),Beighton hypermobility score, valgus index, thigh foot angle examination were used.
15964864|NCT03151525|Drug|Azathioprine|AZA treatment after IFX withdrawal for maintenance of remission
15964865|NCT03151525|Drug|Infliximab|IFX treatment for maintenance of remission
15964866|NCT03151499|Drug|BI 409306|Reference and Test Treatment
15964867|NCT03151499|Drug|Rifampicin|Test Treatment
15964868|NCT03151486|Drug|JNJ-55308942 0.5 mg|Participants will receive JNJ-55308942 0.5 mg as an oral solution after an overnight fast on Day 1.
15964869|NCT03151486|Drug|JNJ-55308942 1.5 mg|Participants will receive JNJ-55308942 1.5 mg as an oral solution after an overnight fast on Day 1.
15964870|NCT03151486|Drug|JNJ-55308942 4 mg|Participants will receive JNJ-55308942 4 mg as an oral solution after an overnight fast on Day 1.
15964871|NCT03151486|Drug|JNJ-55308942 12 mg|Participants will receive JNJ-55308942 12 mg as an oral solution after an overnight fast on Day 1.
15964872|NCT03151486|Drug|JNJ-55308942 36 mg|Participants will receive JNJ-55308942 36 mg as an oral solution after an overnight fast on Day 1.
15964873|NCT03151486|Drug|JNJ-55308942 100 mg|Participants will receive a single oral dose of JNJ-55308942 100 mg as an oral solution after an overnight fast on Day 1.
15964874|NCT03151486|Drug|JNJ-55308942: Fed State|Participants will receive JNJ-55308942 as an oral solution in fed state on Day 1. The dose selected for this cohort will be based on the data obtained from the single ascending dose cohorts.
15964875|NCT03151486|Drug|JNJ-55308942: MAD Part|Participants will receive JNJ-55308942 once daily as an oral solution for 10 consecutive days (Day 1 to 10). The doses for the MAD will be determined based on the data from the SAD part.
15964876|NCT03151486|Drug|Placebo|Participants will receive matching placebo in all cohorts.
15964877|NCT03151460|Drug|Dopamine Agent|"Patients were assessed in two experimental conditions that were performed on different days, with an intersession interval of about one month. In the off condition PD subjects performed the experimental tasks in the morning after 12/18 hours of Dopamine Agent withdrawal. In the on condition they were examined 90-120 minutes after they had taken their first morning dose of levodopa and/or dopamine agonists."
15964878|NCT03151447|Radiation|stereotactic body radiation therapy|"In patients with metastatic triple negative breast cancer, stereotactic body radiation therapy will be combined with anti-PD-1 antibody.
~Stereotactic body radiation therapy: SBRT is delivered to 1~5 measurable metastatic lesions of liver, lung, bone, brain or lymph nodes in limited fractions .
~Anti-PD-1 treatment: anti-PD-1 antibody (JS001) is injected intravenously 120mg or 240mg or 360mg every two weeks."
15964879|NCT03151434|Drug|US Guided Single Shot Paravertebral Block (0.2% ropivicaine infusion)|Single shot paravertebral block will be placed under ultrasound guidance at the thoracic region prior to surgery.
15964880|NCT03151434|Drug|US Guided Paravertebral Catheter (0.2% ropivicaine bolus)|Paravertebral catheter will be placed under ultrasound guidance at the thoracic region prior to surgery.
15964881|NCT03151434|Drug|Thoracic Epidural (0.125% bupivicaine/hydromorphone)|Epidural catheter will be placed in the thoracic region prior to surgery.
15964882|NCT03151421|Behavioral|Home air quality monitoring and feedback|Two-hundred smokers (50 in each country) will be recruited and offered low-cost, simple to operate particle counting instruments to measure and log SHS levels in their home for a period of 30 days. During this time near real-time, personalised feedback will be provided to, and discussed with, the smoker along with target-setting and exploration of suitable methods of behaviour-change. Feedback will be given via text message to mobile phones, emails and personal voicecalls. A final visit will gather data on changes made while a proportion of participants (10-20%) in each country will take part in a further qualitative interview by phone to gather data on their experience of the intervention.
15964883|NCT03151408|Drug|Pracinostat|60 mg capsule
15964884|NCT03151408|Drug|Placebos|capsule
15964885|NCT03151408|Drug|Azacitidine|SC or IV injection
15964886|NCT03151395|Other|Sputum and blood sampling|Evaluation of the occurrence of potential bacterial and viral pathogens in the sputum of stable COPD patients and at the time of AECOPD.
15964887|NCT03151382|Drug|Tandospirone Citrate|Tandospirone, 30-60 mg/d
15964888|NCT03151382|Drug|Donepezil Hydrochloride|Donepezil, 10 mg/d
15964889|NCT03151369|Drug|Morphine|patients with the visual analog scale over 3 will receive morphine
15964890|NCT03151356|Device|Measurement of Prostate Health Index (PHI)|Use of a diagnostic tool to predict prostate biopsy outcome: measurement of total and free PSA as well as the [-2]proPSA and calculation of The Prostate Health Index according to the following formula: Prostate Health Index (PHI) = [p2PSA /fPSA] x √tPSA
15964891|NCT03151343|Drug|Empagliflozin|Empagliflozin tablet
15964892|NCT03151343|Drug|Placebo Oral Tablet|Sugar pill, visually identical to active comparator
15965048|NCT03150290|Other|Indirect Calorimetry.|REE measurement
15964894|NCT03151304|Drug|Pracinostat|45 mg capsule
15964895|NCT03151304|Drug|Azacitidine|SC or IV injection
15964896|NCT03151291|Dietary Supplement|β-hydroxy-β-methylbutyrate (HMB)|daily intake of 3 g HMB
15964897|NCT03151291|Dietary Supplement|L-carnitine (LC)|daily intake of 4 g LC
15964898|NCT03151291|Dietary Supplement|Eicosapentaenoic acid (EPA)|daily intake of 2.2 g EPA
15964899|NCT03151291|Other|Whole-Body Electromyostimulation (WB-EMS)|WB-EMS training is performed 2x/week for 12 weeks; Stimulation protocol: Frequency of 85 Hz, pulse duration of 0.35 ms, stimulation period of 6 sec, resting period of 4 sec; supervised by certified training instructors/physiotherapists participants perform simple exercises during the stimulation period following a video tutorial
15964900|NCT03151278|Procedure|Zero-fluoroscopy ablation|Catheter ablation will be performed under the guidance of one kind of three-dimensional navigation system and without fluoroscopic guidance.
15964901|NCT03151278|Procedure|Conventional fluoroscopy ablation|Catheter ablation will be performed using fluoroscopy plus one kind of three-dimensional navigation system.
15964902|NCT03151265|Device|ThermaCare Low Back Heat Wrap|The ThermaCare Low Back Heat Wrap, is a continuous, low-level, direct heat therapy. It comes in the form of a heat-pack that is strapped to the low back. Heat is provided for approximately 8-hours.
15964903|NCT03151252|Diagnostic Test|Cytobrush|During the endoscopic Investigation the mucosa cells were collected by brushing the colon via cytobrush.
15964904|NCT03151239|Dietary Supplement|NMN supplement|Intervention will last at least 8 weeks in the form of two capsules (250 mg total).
15964905|NCT03151239|Other|Placebo|Intervention will last at least 8 weeks in the form of two capsules.
15964906|NCT03151226|Device|Capnography monitoring|capnography and pulse oximetry will be initiated in the recovery room and worn for 12-24 hours post delivery
15964907|NCT03151213|Drug|Pregabalin 150mg|Pregabalin 150mg before RFA of liver cancer
15964908|NCT03151213|Other|Placebo|Placebo before RFA of liver cancer
15964909|NCT03151200|Device|Computer based binocular treatment|Binocular amblyopia treatment involves presenting stimuli over a computer screen to the amblyopic eye those are at higher contrast compared to the stimuli that are presented to the good eye, which balances the performances of the two eyes and over time improves the amblyopic eye vision.
15964910|NCT03151200|Device|Transcranial magnetic stimulation|TMS is a non-invasive research method that generates electrical current at the cortex that can excite neuronal activities and neuronal plasticity.
15964911|NCT03151187|Other|Teaching intervention|Two two hour teaching modules on the diagnosis and treatment of disruptive behaviour disorders in children and youth
15964912|NCT03151174|Drug|Vitamin D 10000 UNT|10000 IU Vitamin D per day
15964913|NCT03151174|Drug|Vitamin D 5000 UNT|5000 IU Vitamin D per day
15964914|NCT03151161|Drug|Icotinib,Pemetrexed,Carboplatin|Pemetrexed (500mg/m2) + Carboplatin (AUC=5), every 3 weeks, maximum 4 cycles; icotinib 125mg, three times a day, d2-15 in each cycle, and icotinib 125mg,three times a day, since the last cycle until disease progression
15964915|NCT03151161|Drug|Icotinib|Single drug: Icotinib 125mg, three times a day, continuous until disease progression.
15964916|NCT03151148|Biological|TMT Lotion|TMT product and Vegetable glycerin-Cetaphil®
15964917|NCT03151148|Drug|Placebo Lotion|Cetaphil® moisturizing lotion and vegetable glycerin
15964918|NCT03151122|Behavioral|Nurse-led Continuous Support|"The Nurse-Led Continuous Support was provided by a integrative care team. In-hospital support included(1) Promoting early parental-infant interaction;(2) Instruct the mother and/or father to use sensory stimulation activities to promote infant neuro-development in the NICU;(3) Parental educational support. The integrative care team will teach infant care skills, prepare them for successful transition from hospital to home setting.
~After infant discharge support will consist of regular home visits by the nurses. Home visits will be offered every other week until children reaching 3 Months of corrected age."
15964919|NCT03151122|Procedure|routine follow-up care|after infant discharge, parents were usually called upon to remind the date and time of follow-up care with physicians in outpatient department. A contact number was also given to parents in case they have questions about follow-up care.
15964920|NCT03151109|Diagnostic Test|CT Scan|CT scan at minimum 1 year post op
15964921|NCT03151096|Dietary Supplement|Riboflavin|one pill of Riboflavin will be taken orally with water
15964922|NCT03151096|Dietary Supplement|Placebo|one pill of placebo will be taken orally with water
15964923|NCT03151083|Behavioral|Internet-based Self-help Insomnia Intervention|The investigators will use the program, SHUTiTM for the treatment of insomnia. The intervention is a CBT-based 6-week, self-administered course accessed via the Internet on mobile, desk-top, and other devices. The program is split into six modules, completed weekly, which include instruction on psycho-education, stimulus control, relaxation training, sleep restriction, medication tapering, and addressing cognitive distortions. The content is delivered via text, video vignettes, case histories, interactive learning tools, interactive skills assessments, symptom assessments, and a sleep log. Homework is assigned after each module. Providers and support staff can follow treatment progress via access to a dashboard of patient information collected by the program. Such information includes progress through the modules, date of last engagement, symptom assessment outcomes, and sleep log data abstracted into commonly used sleep indices such as sleep onset latency and sleep efficiency.
15964924|NCT03151070|Other|QVLM Intervention package|"QVLM intervention package consists of 3 simultaneous interventions:
~Social marketing to promote insitutional deliveries.
~PRONTO training to public health personnel
~Improve interaction with traditional birth attendants"
15964925|NCT03151057|Drug|Idelalisib 100 MG|100mg BID beginning on day 90 (+/- 10days) and continuing until day 270 post transplant.
15964926|NCT03151057|Drug|Placebo Oral Tablet|placebo
15964927|NCT03151044|Drug|High-dose Epirubicin Combined with CVP ± Rituximab|Experimental group shall be given high-dose Epirubicin (90mg/m2) combined with standard-dose Cyclophosphamide (750mg/m2), Vincristine (1.4mg/m2) and Prednisolone (100mg/m2) ± Rituximab
15965049|NCT03150290|Device|18-FDG-PET|18-FDG-PET
15965050|NCT03150277|Behavioral|Plyometric exercise|2 sets of 10 ankle hops, 3 sets of 5 hurdle hops, 5 drop-jumps from a height of 50 cm
15964928|NCT03151044|Drug|Standard-dose Epirubicin Combined with CVP ± Rituximab|Active comparator group shall be given standard-dose Epirubicin and standard-dose Cyclophosphamide (750mg/m2), Vincristine (1.4mg/m2) and Prednisolone (100mg/m2) ± Rituximab
15964929|NCT03151031|Procedure|Cryotherapy|The cooling procedure for the knee joint will be initiated by using a cryopack or cold-pack. On completion of the initial SEBT, the participant will lie supine and the investigator will apply the cryotherapy for 10 minutes. After the 10 minute period of cryotherapy, the cryopack will be removed, and the participants will perform SEBT for the second time.
15964930|NCT03151018|Device|Resolute Onyx|
15964931|NCT03151005|Drug|Metformin-GLP-1 Receptor Agonist|metformin oral with exenatide/liraglutide subcutaneous injection.
15964932|NCT03151005|Drug|Metformin-Oral Contraceptive(OC)|metformin with Diane 35 oral intake.
15964933|NCT03150992|Dietary Supplement|Elemental 028 Extra Liquid|A nutritionally complete, liquid elemental diet consisting of a mixture of essential and non-essential amino acids, carbohydrate, fat, vitamins, minerals, trace elements and flavourings with sugars & sweeteners.
15964934|NCT03150979|Other|Provision of a cane|The participants will receive a single-point cane and will be instructed to use it all the time during locomotion. Weekly, they will receive a phone call, to ensure that they are using the cane and to clarify any doubts. A home visit may be conducted, if necessary.
15964935|NCT03150979|Other|Control|The control group will be instructed to to perform stretching of the lower limb muscles daily and keep their daily activities, without the use of a cane. They will also receive weekly phone calls, to ensure similar level of attention to that of the the participants in the experimental group.
15964936|NCT03150966|Drug|Nanocurcumin|Patients will take 80 mg nanocurcumin in the form of capsules daily during the 6 month study period
15964937|NCT03150966|Drug|Placebo|Patients will take placebo in the form of capsules daily during 6 months study period
15964938|NCT03150953|Device|MRI-safe bore covering|
15964939|NCT03150940|Diagnostic Test|ECG|12 lead electrocardiogram used to demonstrate cardiac function
15964940|NCT03150940|Diagnostic Test|bedside cardiac ultrasound|bedside cardiac ultrasound to see 2D images of each participants heart. Without the use of radiation.
15964941|NCT03150927|Dietary Supplement|Probiotic Microbial Composite|125mg (or 250 mg) of BiOWiSH Probiotic Microbial Composite™ is to be dosed once daily. Product will be supplied in capsule form to be administered orally. Each subject will be given a 15-day supply (30 capsules) to take with them after their initial visit. Capsules will be administered every 15 days by primary investigators at follow up visits.
15964942|NCT03150927|Dietary Supplement|Placebo|125mg (or 250 mg) of Placebo is to be dosed once daily. Product will be supplied in capsule form to be administered orally. Each subject will be given a 15-day supply (30 capsules) to take with them after their initial visit. Capsules will be administered every 15 days by primary investigators at follow up visits.
15964943|NCT03150914|Drug|Sirolimus|mTOR inhibitor or placebo
15964944|NCT03150901|Diagnostic Test|no drug|laboratory tests
15964945|NCT03150888|Drug|Antihypertensive Agents|Single or combination therapy with five type of antihypertensive agents, such as Ca channel blockers, ACE inhibitors, ARBs, diuretics, or beta-blockers.
15964946|NCT03150888|Other|Cardiovascular risk factors|Different level of cardiovascular risk factors associated with genetics, environments and lifestyles.
15964947|NCT03150875|Drug|IBI308|Anti-PD-1 therapy in Chinese squamous NSCLC patients will be investigated in this clinical trial.
15964948|NCT03150875|Drug|Docetaxel|As 2nd line treatment to subjects with squamous NSCLC
15964949|NCT03150862|Drug|Pamiparib|Administered as specified in the treatment arm
15964950|NCT03150862|Drug|TMZ|Administered as specified in the treatment arm
15964951|NCT03150862|Radiation|Radiation|Up to 60 Gy (total) over 6 - 7 weeks
15964952|NCT03150849|Diagnostic Test|C-X-C Chemokine Receptor 4|marker assessed by flowcytometry in a blood sample
15964953|NCT03150836|Drug|Durvalumab|All participants will receive durvalumab 1500 mg via IV infusion every 4 weeks for up to 13 doses.
15964954|NCT03150836|Drug|Tremelimumab|Participants receiving Regimen B (safety lead-in or expansion cohort) will be administered tremelimumab 75 mg via IV infusion every 4 weeks for 1 cycle or 2 cycles.
15964955|NCT03150836|Radiation|Radiation Therapy|In all arms of the study, participants will receive 5 fractions of radiation. The radiation dose will either be 6.6 Gy for a total dose of 33 Gy, or 6.0 Gy for a total dose of 30 Gy.
15964956|NCT03150823|Procedure|Upward Direct Current (Ascending Effect)|Application of direct current (Galvanic) in milliamperes current which varies according to the positioning of the electrodes. In the ascending stream direct current (Ascending effect) the proximal cathode and distal anode are placed, a excitatory effect on the nervous system being described in theory.
15964957|NCT03150823|Procedure|Downward Direct Current (Descending Effect)|Application of direct current (Galvanic) in milliamperes current which varies according to the positioning of the electrodes. In the descending stream direct current (Descending effect) the proximal anode and distal cathode are placed, a sedative and analgesic effect on the nervous system being described in theory.
15964958|NCT03150823|Procedure|Sham Direct Current|Installation of electrotherapy equipment off (Sham tratment).
15964959|NCT03150810|Drug|Pamiparib|60 mg (20 mg capsules) administered orally twice a day
15964960|NCT03150810|Drug|Temozolomide|Doses of up to 120 mg (as 20 mg capsules) administered orally once daily (QD) as specified in the treatment arm
15964961|NCT03150797|Drug|Melatonin|Melatonin
15964962|NCT03150797|Drug|Placebo oral capsule|Placebo
15964963|NCT03150784|Other|EPIC Club|Weekly exercise gym sessions. Participants will start with a warm-up of 20-25 mins cardiovascular training either doing cycling, treadmill running or cross-training. The remainder of the session consists of strength/resistance and weight-training involving leg press, leg extensor, pull downs, kettle bells, dumbbells. In addition to the above, a novel rhythmical stepping task will be performed over 10 mins.
15964964|NCT03150771|Drug|Aripiprazole|Injection
15964965|NCT03150758|Device|10Hz + 100 micro-seconds|10Hz Electrical Stimulation with a pulse width of 100 micro-seconds
15964966|NCT03150758|Device|10Hz + 200 micro-seconds|10Hz Electrical Stimulation with a pulse width of 200 micro-seconds
15964967|NCT03150758|Device|7Hz + 100 micro-seconds|7Hz Electrical Stimulation with a pulse width of 100 micro-seconds
15964969|NCT03150745|Procedure|3- Cervical Pap smears|Cervical Pap smears will be obtained using the long tip of an Ayre's spatula that will be placed in the endocervical canal with the proximal bulge resting on the ectocervix. The spatula will be carefully rotated around the cervix so that a representative sample of the whole cervix will be obtained. An additional endocervical sample will be obtained by placing a cytobrush or by the other end of the Ayer's spatula in the endocervical canal and gently rotated through 360 degrees as previously described. The samples will be then immediately plated on a slide, fixed by immersing the slide in 95% ethyl alcohol fixative for 15 to 20 minutes and stained by modified Papanicolaou stain using a hand staining procedure
15964970|NCT03150745|Procedure|Colposcopic examination|"0.9% saline technique to assess the cervical lesion and vasculature of the cervix, 5% acetic acid technique to determine acetowhite-positive areas. Schiller's iodine technique to visualize high glycogen containing cells. Endocervical canal assessment using (Bossman forceps or endocervical speculum or counter pressure with Q stick).
~e- Biopsy using the punch biopsy forceps. Biopsy will be obtained from every abnormal colposcopic examination"
15964971|NCT03150745|Procedure|Office hysteroscopy|0.9% saline technique to assess the cervical lesion and vasculature of the cervix. 5% acetic acid technique to determine acetowhite-positive areas. Schiller's iodine technique to visualize high glycogen containing cells. Endocervical canal assessment. Endometrial cavity evaluation whenever possible. Biopsy. Biopsy will be obtained from every abnormal hysteroscopic examination.
15964972|NCT03150732|Drug|Systemic nalbuphine|Patients will receive systemic nalbuphine 10 mg
15964973|NCT03150732|Drug|Local nalbuphine|Patients will receive local nalbuphine 10 mg
15964974|NCT03150719|Drug|Tezacaftor/Ivacaftor|TEZ 100 mg/IVA 150 mg fixed-dose combination tablet.
15964975|NCT03150719|Drug|Ivacaftor|IVA 150 mg tablet.
15964976|NCT03150719|Drug|Placebo|Placebo matched to TEZ/IVA fixed-dose combination tablet.
15964977|NCT03150719|Drug|Placebo|Placebo matched to IVA tablet.
15964978|NCT03150706|Drug|Avelumab|"Patients will receive 10 mg/kg of avelumab via intravenous infusion every 2 weeks.
~Response evaluation will be performed every 6 weeks (± 1-week window period). Treatment will be continued until disease progression, unacceptable adverse events or the patient's refusal.
~Treatment through progression is at the investigator's discretion, and the investigator should ensure that patients do not have any significant, unacceptable, or irreversible toxicity that indicate that continuing treatment will not further benefit the patient. The Investigator should ensure that patients still meet all of the inclusion criteria and none of the exclusion criteria for this study."
15964979|NCT03150693|Drug|Allopurinol|Given PO
15964980|NCT03150693|Drug|Cytarabine|Given IT, IV, SC
15964981|NCT03150693|Drug|Daunorubicin Hydrochloride|Given IV
15964982|NCT03150693|Drug|Vincristine Sulfate|Given IV
15964983|NCT03150693|Drug|Dexamethasone|Given PO or IV
15964984|NCT03150693|Drug|Pegylated L-Asparaginase|Given IV
15964985|NCT03150693|Drug|Methotrexate|Given IT, IV, PO
15964986|NCT03150693|Procedure|Bone Marrow Aspiration and Biopsy|Undergo bone marrow aspiration and biopsy
15964987|NCT03150693|Drug|Cyclophosphamide|Given IV
15964988|NCT03150693|Drug|Mercaptopurine|Given PO
15964989|NCT03150693|Biological|Rituximab|Given IV
15964990|NCT03150693|Drug|Doxorubicin|Given IV
15964991|NCT03150693|Drug|Thioguanine|Given PO
15964992|NCT03150693|Biological|Inotuzumab Ozogamicin|Given IV
15964993|NCT03150693|Other|Laboratory Biomarker Analysis|Correlative studies
15964994|NCT03150680|Genetic|SNPs associated with CAD, SNPs associated with pharmacological response to clopidogrel and statins|Genotyping will be carried out by Next-Generation Sequencing (NGS)
15964995|NCT03150667|Drug|Ticagrelor|Ticagrelor in patients with CKD presenting with ACS.
15964996|NCT03150667|Drug|Clopidogrel|Clopidogrel in patients with CKD presenting with ACS.
15964997|NCT03150654|Device|Laser pan-retinal photocoagulation|Green laser photocoagulator
15964998|NCT03150641|Procedure|Umbilical cord clamping|The umbilical cord will be clamped and cut after delivery, with timing as specified in each arm
15964999|NCT03150628|Drug|Perioperative chemotherapy|Perioperative chemotherapy
15965000|NCT03150628|Procedure|Cytoreduction|Cytoreductive surgery
15965001|NCT03150628|Drug|HIPEC|Hyperthermic intraperitoneal chemotherapy (HIPEC) with 100mg/m2 cisplatin
15965002|NCT03150615|Other|Early enteral nutrition|"Naso-jejunal tube will be placed intraoperatively. The distal end of the feeding tube would be placed at 30 cm distal to Treitz ligament. Standard enteral diet, administered through a nasojejunal tube, is started on the 1st postoperative day and increased daily by 20-40 ml up to the estimated level.
~After PD, enteral nutrition liquid regimen will be used step by step from postoperative day 1 to postoperative day 7.Patients are targeted to receive calories for 25 kcal/kg/day. Meanwhile, oral food intake was not restricted."
15965003|NCT03150615|Other|Saline|"Naso-jejunal tube will be placed intraoperatively. The distal end of the feeding tube would be placed at 30 cm distal to Treitz ligament.
~After PPPD,Only Normal Saline were given through nasojejunal tube. Entral nutrition was not administrated. Patients intake food orally at will."
15965004|NCT03150615|Device|nasojejunal tube insertion|
15965005|NCT03150615|Other|Oral intake|Patients was encouraged to drink water on postoperative day 1, to eat liquid diet on postoperative day 2, to eat semi-solid on postoperative day 3, to eat solid food on postoperative day 4.
15965006|NCT03150602|Drug|Pralatrexate|This is a single arm study. Pralatrexate will be administered via IV over 3-5 minutes into a IV line containing normal saline (0.9% sodium chloride, NaCl) with the initial dose of 30 mg/m2/week on days 1, 8, 15, 22, 29, and 36 for 6 weeks in a 7-week cycle. The scheduled date can be done within a window time of plus or minus 1 day. The pralatrexate dose may be reduced to 20 mg/m2/week or omit if a patient experiences adverse events. Pralatrexate administration can be up to 5 cycles or until subject meets withdrawal criteria.
15965007|NCT03150589|Drug|SB11 (Proposed ranibizumab biosimilar)|SB11 (proposed ranibizumab biosimilar) 0.5mg via intravitreal injection every 4 weeks
15965008|NCT03150589|Drug|Lucentis (ranibizumab)|Lucentis (ranibizumab) 0.5mg via intravitreal injection every 4 weeks
15965009|NCT03150576|Drug|Olaparib|Patients will self-administer Olaparib by mouth. Olaparib tablets should be taken twice daily at the same time each day approximately 12 hours apart.
15965738|NCT03144570|Other|None, non-interventional study|Not applicable, non-interventional study
15965010|NCT03150576|Drug|Paclitaxel and Carboplatin|Paclitaxel I.V. 80mg/m2 in 0.9% sodium chloride 500ml or according to local practice, will be given over 60 minutes on days 1, 8 & 15, every 3 weeks for 4 cycles. Carboplatin I.V. AUC5 in 5% dextrose 500ml or according to local practice, over 30-60minutes on day 1 every 3 weeks for 4 cycles.
15965011|NCT03150563|Other|Passive static stretch|Each experimental group will be submitted to 10 (ten) sessions, with three (3) weekly sessions of static passive stretching, with a 48 h interval between them. Each session will be performed 3 (three) maneuvers containing a duration of 30 seconds, this being the same rest time, performed in all experimental groups.
15965012|NCT03150550|Behavioral|Mindfulness practice|Mindfulness interventions are behavioral cognitive psychotherapies which allow patient to identify, pay attention and accept external (sensory stimuli) and internal (cognition and emotions) phenomena.
15965013|NCT03150550|Behavioral|Relapse prevention|It's a conventional relapse prevention program which allow to measure the alcoholic relapse in the first glass consumed.
15965014|NCT03150537|Biological|Fluviral influenza vaccine|Influenza vaccine (Fluviral) given via Med-Jet H4 or IM injection
15965015|NCT03150524|Diagnostic Test|TCD- cerebral blood flow velocities|Participants will undergo daily TCD for monitoring of cerebral blood flow.
15965016|NCT03150524|Behavioral|Headache pain score|Participants will be evaluated by nurses for headache frequency and severity every shift.
15965017|NCT03150524|Other|Neurological examination|Patients will be examined routinely for evidence of neurological improvement/decline and/or evidence of a complication such as stroke or hemorrhage.
15965018|NCT03150524|Diagnostic Test|Repeat Neuroimaging|All patients will also be seen at 90 days (+/- 30 days) and administered a headache diary, repeat neuroimaging, and neurological examination.
15965019|NCT03150524|Drug|Nimodipine|Participants will be administered nimodipine every 4 hours.
15965020|NCT03150524|Drug|Verapamil ER|Participants will be administered long acting verapamil every 12 hours.
15965021|NCT03150511|Drug|Tesamorelin 2 Milligrams (MG)|Daily self-administered study drug
15965022|NCT03150511|Drug|Placebo|Daily self-administered placebo
15965023|NCT03150498|Drug|BTD-001|BTD-001 in fed vs fasted state
15965024|NCT03150485|Device|JJVC Fitting Guides|Subjects who are habitual contact lens wearers with Presbyopic correction or Presbyopic symptoms, at least 40 years of age and no more than 70 years of age, will be fitted, according to the fitting guides, with either the Multifocal Contact Lens or an Toric Multifocal Contact Lens if refractive cylinder power of the eye is between -1.00 to -1.50. The Intervention is approximately 30-90 minutes of wear time during a 1-day visit.
15965025|NCT03150472|Device|Graft Matrix|Both Graft matrix products are supplied sterile, for single use only and packed in vials or a syringe-like applicator. All products consist of the same bone graft particles with the only variants being due to different amounts per package or different containers.
15965026|NCT03150459|Drug|Simvastatin 20 mg|Simvastatin 20 mg/day for 12 weeks (Group 1)
15965027|NCT03150459|Drug|Simvastatin 40mg|Simvastatin 40 mg/day for 12 weeks (Group 2)
15965028|NCT03150459|Drug|Rifaximin 400 mg|Rifaximin 400 mg/8 hours for 12 weeks (Group 1 and 2)
15965029|NCT03150459|Other|Placebo of Simvastatin|Placebo of Simvastatin for 12 weeks (Group 3)
15965030|NCT03150459|Other|Placebo of Rifaximin|Placebo of Rifaximin for 12 weeks (Group 3)
15965031|NCT03150446|Device|flexible cystoscopy|After intracorporeal insertion of the double-J catheter, additional endoscopic monitoring with flexible cystoscopy was performed. The surgeon manipulating the double-J catheter used monitor A, while an assistant inserted a flexible cystoscope into the bladder through the urethral route and determined whether the double-J stent was correctly placed in the bladder using monitor B before suturing the site of ureterotomy. If the stent was well-placed, the flexible cystoscope was withdrawn. If the double-J stent was not visualized in the bladder, the surgeon pushed the stent inferiorly using a laparoscopic instrument and monitor A until the stent came out through the ureteral orifice on monitor B.
15965032|NCT03150433|Behavioral|Behavioral symptom management|Individual sessions focused on behavioral and cognitive strategies for managing sleep disturbance, pain, and other symptoms of sickle cell disease
15965033|NCT03150433|Other|Sickle cell disease management|Individual sessions focused on understanding and managing sickle cell disease
15965034|NCT03150420|Drug|Sodium Thiosulfate|Intravenous Sodium Thiosulfate Injection (25 grams sodium thiosulfate) to be administered each hemodialysis session (3 times weekly) for 3 weeks
15965035|NCT03150420|Drug|Placebo-Normal Saline|Placebo: to be administered each hemodialysis session (3 times weekly) for 3 weeks
15965036|NCT03150394|Dietary Supplement|GASTRUS|Gastrus will be given from the first day of eradication treatment to completion after 30 days of treatment
15965037|NCT03150394|Other|PLACEBO|Placebo will be given from the first day of eradication treatment to completion after 30 days of treatment
15965038|NCT03150381|Behavioral|Weight Loss Only|24- month weight loss program (year 1: weekly in person meetings for 6 months, followed by 2 meetings per month for 3 months, then monthly for 3 months; year 2: monthly phone calls)
15965039|NCT03150381|Behavioral|Weight Loss Plus|Participants will attend in-person weekly sessions (about 1.5 hours each) for 6 months and then twice a month for 3 months and monthly for 3 months. Sessions focus on behavioral techniques supporting healthy diet (including calorie restriction for weight loss) and achieving recommended amounts of physical activity per week. During 1-year weight loss maintenance, participants receive monthly motivational phone calls.
15965040|NCT03150381|Behavioral|Control|Participants receive quarterly newsletters containing generic cancer prevention messages and participate in community-wide cancer awareness educational sessions.
15965042|NCT03150355|Procedure|Arthroplasty or open reduction and internal fixation|fixation of proximal femoral fractures or replacement with prosthesis
15965043|NCT03150342|Diagnostic Test|myocardial perfusion imaging|dipyridamole-stressed MPI scan using thallium-201
15965044|NCT03150329|Other|Laboratory Biomarker Analysis|Correlative studies
15965045|NCT03150329|Biological|Pembrolizumab|Given IV
15965046|NCT03150329|Drug|Vorinostat|Given PO
15965047|NCT03150316|Drug|Treat Regimen|CKD-581(investigational Drug): on days 1, 8, 15 of repeated 28day cycles Lenalidomide: on days 1~21 of repeated 28 day cycles Dexamethasone: administrated once weekly every 28day cycles
15965051|NCT03150277|Behavioral|Heavy resistance exercise|10 single repetitions of back half squats at 90% of 1 repetition maximum
15965052|NCT03150264|Device|PCV-VG, PEEP5cmH₂O|This is an innovative ventilation mode developed in recent years. The preset tidal volume help the machine modify inspiratory pressures and compensate the decrease of lung compliance.
15965053|NCT03150264|Device|PCV, PEEP5cmH₂O|This is a traditional ventilation mode used in obese patients in the past.
15965054|NCT03150251|Other|Cereal - oats|Consumption of one cereal in the beginning of each visit
15965055|NCT03150251|Other|Cereal - cream of rice|Consumption of one cereal in the beginning of each visit
15965056|NCT03150238|Other|observation of prognostic factors for relapse|The identification of the most relevant prognostic factors and the definition of their weight in predict the risk of re-intervention will be the basis for the definition of a combined score
15965057|NCT03150225|Other|Concurrent training|"In this protocol the participants will perform aerobic and resistance training according to published evidence for middle-aged men; Characterized as concurrent training.
~The protocol will last six months and will be divided into two quarters. In the first trimester, initial 30 minutes will be assigned to resistance training, followed by 30 minutes of aerobic training; Already in the second trimester will be 20 initial minutes for the aerobic training and later 40 minutes for the resistance training; Aiming to obtain benefits in the levels of muscular strength, aerobic capacity, body composition, besides positive results in relation to the hormonal adaptations of testosterone, as well as in the psychological well being of the participants. Classes will occur at a frequency of three times weekly, lasting 60 minutes a session."
15965058|NCT03150225|Dietary Supplement|Eurycoma longifolia|Eurycoma longifolia will be administered by supplementation with the standard aqueous-soluble extract extract (Physta ™) in single 200mg capsules daily, and placebo by starch capsules. The supplementatio will last six months.
15965059|NCT03150212|Dietary Supplement|Saccharomyces cerevisiae CNCM I-3856|2 capsules daily, just before the breakfast with a glass of water, during 8 weeks.
15965060|NCT03150212|Dietary Supplement|Placebo|2 capsules daily, just before the breakfast with a glass of water, during 8 weeks.
15965061|NCT03150199|Behavioral|Positive Psychology + Motivational Interviewing|Participants randomized to PP-MI will receive a treatment manual. For each session, a PP exercise will be described in the manual, with instruments and space to write about the exercise and its effects. Next, an MI section will outline specific MI-based topics (e.g., pros/cons, managing slips) and facilitate physical activity goal-setting. Following randomization, participants will engage in weekly, 30-minute phone calls over the next 8 weeks. Participants will independently complete PP exercises and MI-based goals between phone sessions and review them during phone sessions. PP and MI components will be delivered step-wise within sessions (rather than intertwined).
15965062|NCT03150199|Behavioral|MI-based Health Education Intervention|Each week, participants will learn about a different health behavior topic related to diabetes health. As an attentional control, this condition has a parallel structure to the experimental arm with a treatment manual, weekly assignments, and weekly calls to review assignments. Motivational interviewing topics (e.g., pros and cons of behavior change, importance and confidence of behavior change, identification of barriers and resources to change) will be presented related to each health behavior.
15965063|NCT03150186|Other|SHS exposure in homes|The investigators will recruit 20 non-smoking volunteers living in different homes with at least one smoker: 10 participants living in more deprived neighborhoods and 10 participants living in wealthier neighborhoods. Nicotine vapor phase will be measured using passive SHS samplers. The investigators will contact with participants and make an arrangement for measuring levels of nicotine at homes. First, the investigators will hang up a passive sampler in the main room of the house in accordance with the written protocol of sample collection. One week later, the investigators will come back to the house in a second visit to remove the sample. During the second visit the investigators will administer a specific questionnaire about environmental tobacco exposure to the participant.
15965064|NCT03150186|Other|SHS exposure in private cars|The investigators will measure levels of nicotine in 30 cars (two samples per car) in 2 European countries with different smoke-free legislation (Spain and UK). A convenience sampling will be performed considering feasibility. The investigators will recruit 30 drivers: 10 daily-smoking volunteers that usually smoke within their car; 10 daily-smoking volunteers that do not smoke within their car; and 10 non-smoking volunteers. To be eligible, participants have to spend a minimum of 30 minutes per day within the car. Nicotine vapor phase will be measured using passive SHS samplers. Two samplers will be hung up in each car during a period of 24 hours. One sampler will be open during the 24-hour sampling period. The other sampler will be only open during travelling time.
15965065|NCT03150186|Other|SHS exposure in outdoor settings|In three types of outdoor settings (children playgrounds, terraces of hospitality venues, and entrances of primary school buildings), nicotine vapor phase will be measured using active SHS samplers. For each country, a convenience sampling of 60 outdoor settings (20 of each of the above mentioned settings) will be performed. Data collection will be conducted from March to October. The measurements will be able to be taken at any time of day providing that there are at least five adults. The investigators will collect nicotine samples using samplers attached to an air pump. Measurements will last 30 minutes. While measurements are being taken, data collectors will also conduct observations in accordance with the protocol of active sampling collection.
15965066|NCT03150173|Behavioral|Onsite treatment|Participants will see a buprenorphine treatment provider who will assess for clinical criteria for opioid use disorder and write a prescription for buprenorphine treatment, which will be filled in a community pharmacy.
15965067|NCT03150173|Behavioral|Enhanced referral|Participants will receive an expedited appointment at a community health center for evaluation for buprenorphine treatment
15965068|NCT03150173|Drug|Buprenorphine|all participants will receive buprenorphine
15965069|NCT03150160|Drug|brinzolamide 1%/brimonidine 0.2% fixed combination|One drop applied topically to the affected eye(s) in the morning and evening
15965070|NCT03150160|Drug|Placebo|One drop applied topically to the affected eye(s) in the morning and evening
15965071|NCT03150160|Drug|travoprost 0.004% ophthalmic solution|One drop applied topically to the affected eye(s) in the evening
15965072|NCT03150147|Other|Non-ischemic preservation|The device is a portable heart-lung machine; an automatic pressure and flow-controlled perfusion system. The heart is submerged in a solution and the medium is circulated in the heart, at a temperature of 8°C.
15965073|NCT03150147|Other|Ischemic cold static storage|Standard ischemic cold static storage; a crystalloid solution (cardioplegia) is used to stop and preserve the heart. Cardioplegia is given. The heart is storage i a transport box containing ice to keep the temperature around 8°C.
15965074|NCT03150134|Drug|Cyclosporine|Patients with advanced AML received early tapering of immunosuppressive drugs(Cyclosporine)
15965075|NCT03150134|Drug|routine reduction of immunosuppressive drugs(cyclosporine)|patients with AML in CR were given the routine reduction of immunosuppressive drugs(cyclosporine)
15965076|NCT03150121|Procedure|Uterine lavage|Uterine lavage is performed using an intrauterine insemination catheter or rigid pipelle uterine sampler. The catheter is inserted into the cervical canal. 10mL of saline are infused into the uterine cavity and fallopian tubes and immediately retrieved.
15965077|NCT03150121|Procedure|Blood sample|5-10mL of blood will be drawn from participants.
15965078|NCT03150121|Device|Uterine lavage catheter|Uterine lavage is performed using an intrauterine insemination catheter or rigid pipelle uterine sampler. The catheter is inserted into the cervical canal. 10mL of saline are infused into the uterine cavity and fallopian tubes and immediately retrieved.
15965079|NCT03150108|Drug|rhPTH(1-84)|25 mcg rhPTH(1-84) SC injection
15965080|NCT03150108|Drug|rhPTH(1-84)|50 mcg rhPTH(1-84) SC injection
15965081|NCT03150108|Drug|rhPTH(1-84)|100 mcg rhPTH(1-84) SC injection
15965082|NCT03150095|Behavioral|Health coaching|Patients will work with a health coach by telephone
15965083|NCT03150082|Drug|GR37547 tablet|"A single tablet of GR37547 should be taken orally with 240 mL of water. GR37547 500 mg tablet will be a white to off white capsule shape with break line on upper side and embossed GSK500on lower side."
15965084|NCT03150082|Drug|Ciprofloxacin reference tablet|"A single tablet of ciprofloxacin reference should be taken orally with 240 mL of water. Ciprofloxacin 500 mg reference will be nearly white to slightly yellowish film coated oblong tablets with break line and ''CIP 500 marked on upper side and BAYER on lower side."
15965085|NCT03150069|Other|Interview|In-person or telephone in-depth interview
15965090|NCT03150043|Device|Masimo Rainbow Pulse CO-oximeter|Masimo Rainbow Pulse CO-oximeter will be used to measure hemoglobin values of pregnant women during primary cesarean delivery
15965091|NCT03150030|Other|Combined hyper- and hypoglycaemic clamp|During the entire clamp, participants will be monitored by ECG, pulse oximetry, and blood pressure and plasma glucose will be measured bedside every fifth minute. Additionally, patients with type 2 diabetes will be monitored by a loop recorder (LR) and a continuous glucose monitor (CGM). Comparison of LR and CGM recordings with the recordings obtained by ECG Holter monitor and blood sampling will be used for validation of the method used in Part 2 of the study. Blood samples will be drawn and analysed for changes in electrolytes, insulin, glucagon, catecholamines and cortisone. A cardiac haemodynamic evaluation will be performed by echocardiography at baseline, hyperglycaemia, and hypoglycaemia.
15965092|NCT03150030|Device|Loop recorder (Reveal LINQ, Medtronic, Minneapolis, MN, USA)|Implantation of a loop-recorder
15965093|NCT03150030|Device|Continuous glucose monitoring (iPro2, Medtronic, Minneapolis, MN, USA)|Monitoring with a continuous glucose monitor
15965094|NCT03150017|Other|SPIRE|Online pain management programme.
15965095|NCT03150004|Drug|Cladribine, Cytarabine, Mitoxantrone, G-CSF (CLAG-M) regimen|"Patients will be started on CLAG-M regimen, which consists of the following:
~Cladribine 5mg/m2 IV over two hours on days 1-5;
~Cytarabine 2 gm/m2 IV over four hours on days 1-5, starting two hours after the Cladribine infusion is complete;
~Mitoxantrone 10mg/m2 IV on days 1-3;
~G-CSF at a dose of 300 μg on days 0-5."
15965096|NCT03149991|Drug|Brexpiprazole|Administration of up to 3mg brexpiprazole
15965097|NCT03149991|Drug|Ketamine|administration 6 times over two weeks of inhaled ketamine
15965098|NCT03149991|Drug|Placebo|Administration of placebo which matches brexpiprazole in size and number of tablets per dose
15965099|NCT03149965|Other|transperineal ultrasound|transperineal ultrasound was used by placing a vaginal ultrasound probe towards the vaginal distal wall pointing to the anus, measuring the anovaginal distance.
15965100|NCT03149952|Other|Evaluation of the feasibility of the establishment of a logbook in patients hospitalized for allogeneic haematopoietic stem cells|Evaluation of the feasibility of the establishment of a logbook in patients hospitalized for allogeneic haematopoietic stem cells.
15965101|NCT03149939|Drug|Febuxostat 40 milligramsTablet|Febuxostat 40 milligramsTablet every other day for 3 months
15965102|NCT03149926|Other|Stimuli presentation|Different stimuli associated with self-injury are presented. Participants have to rate the emotional effect elected by the stimuli.
15965103|NCT03149913|Device|SequentPlease OTW paclitaxel coated balloon catheter|PTA with SequentPlease OTW paclitaxel coated balloon catheter
15965104|NCT03149913|Device|conventional uncoated balloon for BTK endovascular therapy|PTA with uncoated balloon for BTK endovascular therapy
15965105|NCT03149900|Drug|Secukinumab|See Arm Description
15965106|NCT03149887|Drug|Liposomal bupivacaine|Liposomal bupivacaine solution (Exparel) for injection
15965107|NCT03149887|Drug|Placebo|Inert solution created to appear as liposomal bupivacaine (Exparel) for injection
15965108|NCT03149874|Drug|Hepatitis B Vaccines|either Hepatitis B recombinant DNA vaccine or Combined hepatitis A and B vaccine given to the patients
15965109|NCT03149861|Procedure|PET/MR-ultrasound guided Fusion biopsy|All focal lesion with PI-RADS >=3 on MR or with DCFPyL uptake on PET will undergo a focal fusion biopsy
15965110|NCT03149861|Procedure|Systemic TRUS guided biopsy|Transrectal ultrasound guided systemic prostate biopsy
15965111|NCT03149848|Drug|Cabotegravir|It will be available as a white aquarius film coated tablet for oral administration. CAB Tablet is composed of GSK1265744B (micronized) lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycolate, magnesium stearate
15965112|NCT03149848|Drug|Rifabutin|It will be available as an opaque red-brown hard gelatin capsules containing 150 mg of rifabutin for oral administration. These capsules are composed of rifabutin, microcrystalline cellulose, sodium lauryl sulphate, magnesium stearate, and silica gel
15965113|NCT03149835|Other|Non-invasive ventilation|NIV was provided by BiPAP-Vision™ ventilator (Philips Respironics Inc, Murrysville, PA, USA) set at the BIPAP mode and applied by a nasal mask, with room air, for 60 minutes. Volunteers were studied during the application of NIV (inspiratory pressure of 14cmH2O and expiratory pressure of 4cmH2O), with a pressure support of 10cmH2O and without oxygen support (FIO2 0.21). These pressure levels were chosen based on the current practice of NIV in the intensive care setting.
15965114|NCT03149822|Drug|Cabozantinib|Pharmaceutical form: tablets Route of administration: oral
15965115|NCT03149822|Drug|Pembrolizumab|Pharmaceutical form: solution Route of administration: injection
15965116|NCT03149809|Drug|solifenacin|Antimuscarinic bladder relaxant, antagonizes bladder muscarinic receptors
15965117|NCT03149809|Behavioral|Pelvic floor muscle exercise-based behavioral therapy|Multicomponent intervention including fluid management, constipation management and behavioral techniques incorporating pelvic floor muscle-exercise based urge suppression and self-monitoring to reduce overactive bladder symptoms
15965118|NCT03149796|Other|laboratory blood tests|Serum concentrations of leptin, adiponectin, resistin, interleukin-6 and high sensitivity C reactive protein were measured by ELISA in both study groups
15965119|NCT03149783|Drug|Ropivacaine HCL|Ropivacaine injected after placement of catheters, then infused during the operation
15965120|NCT03149783|Drug|sodium chloride|Placebo
15965121|NCT03149770|Drug|Naloxone|naloxone vs placebo
15965122|NCT03149770|Drug|Placebo|placebo vs naloxone
15965123|NCT03149757|Behavioral|YouTHrive|"The YT website is a mobile-enhanced private social networking website. Participants on the site are anonymous and choose alternate usernames and personalized profile features for a new online identity within YT. The investigators designed YouTHrive to encourage social support, reduce isolation, improve HIV medication adherence, and promote general well being. The study involves rolling recruitment so that new members are continuously entering the intervention. Participants use YT for five months before graduating from the program. The core components of YT are: 1) peer-to-peer interaction in a shared feed; 2) daily monitoring of HIV medication adherence and real-time mood; 3) daily mixed-media content with strategies to improve medication adherence' and 4) goal setting and monitoring."
15965124|NCT03149757|Behavioral|Information-only Control|Participants will receive 21 emails, once per week, for five months. The emails will include static informational content relatable to YLWH, but informational content will not be focused on ART medication adherence.
15965125|NCT03149744|Device|RespiraSense Sleep Screener|RespiraSense will be worn at the same time as the standard of care SomnoScreen and it's results will be masked to the site team
15965126|NCT03149731|Device|NIRS|The recent technological advancement of tissue NIRS enables continuous, real time and bedside monitoring of hemoglobin oxygen saturation in mixed arterial, venous, and primarily capillary blood in the tissue bed being probed.
15965127|NCT03149718|Behavioral|Brief Intervention Medication Therapy Management|BI-MTM is designed to: (1) eliminate opioid medication misuse, (2) promote opioid regimen adherence, (3) connect participants with Patient Navigation to increase patient self-management activation for health conditions that increase risk for misuse (Patient Navigation is an evidence-based chronic care intervention), and (4) provide naloxone rescue training referrals.
15965128|NCT03149718|Behavioral|Standard Medication Counseling (SMC)|Standard Medication Counseling (SMC; n=23; i.e., treatment-as-usual condition). Standard Medication Counseling is the Centers for Medicaid and Medicare Services requirement for pharmacists in the US wherein pharmacy patients filling prescriptions receive information and opt-in counseling.
15965129|NCT03149692|Other|Penile allograft transplantation|Proof of concept of surgical procedure
15965130|NCT03149679|Drug|Cyclophosphamide|Chemotherapy
15965131|NCT03149653|Drug|ClinOleic (baseline)|Lipid emulsion in pharmacy compounded all-in-one admixture
15965132|NCT03149653|Drug|ClinOleic + Omegaven|Lipid emulsion in pharmacy compounded all-in-one admixture
15965133|NCT03149653|Drug|Lipoplus (baseline)|Lipid emulsion in pharmacy compounded all-in-one admixture
15965134|NCT03149653|Drug|Lipoplus + Omegaven|Lipid emulsion in pharmacy compounded all-in-one admixture
15965135|NCT03149653|Drug|SMOFlipid (baseline)|Lipid emulsion in pharmacy compounded all-in-one admixture
15965136|NCT03149653|Drug|SMOFlipid + Omegaven|Lipid emulsion in pharmacy compounded all-in-one admixture
15965137|NCT03149640|Drug|Inhaled amikacin|Once a day, inhaled amikacin at day 4, day 5 and day 6 of invasive mechanical ventilation: 20 mg/kg of ideal body weight, maximum 2 g per day.
15965138|NCT03149640|Drug|Inhaled placebo|Once a day, inhaled placebo at day 4, day 5 and day 6 of invasive mechanical ventilation.
15965139|NCT03149627|Other|Estimates - prevalence of lifetime/chronic HBV infection|Estimation of the prevalence and correlates of lifetime HBV infection defined as hepatitis B core antibody (HBcAb) positivity and chronic HBV infection defined as HBsAg positivity.
15965140|NCT03149614|Other|Spine Mobilizations|Patients receive spinal mobilizations in grades II to III of central posterior-anterior from cervical and thoracic spine as described Maitland in 2000
15965141|NCT03149614|Other|Vertebral Resonant Oscillation|"The vertebral resonant oscillation using the POLD method is similar to spine mobilizations, but there are some differens ; the oscillatory movement has a sinusoidal waveform, the frequency used between 1.2 and 2 Hz and the amplitude is similar to neutral zone to described by Panjabi 1992."
15965142|NCT03149588|Drug|propofol|Using propofol and remifentanil as maintenance of general anesthesia during caesarean section.
15965143|NCT03149588|Drug|sevoflurane|Using sevoflurane and remifentanil as maintenance of general anesthesia during caesarean section.
15965144|NCT03149575|Drug|VAL-083, Dianhydrogalactitol|VAL-083 given by intravenous infusion at a dose 40 mg/m2 IV on days 1, 2, and 3 of a 21-day treatment-cycle, for up to 12, 21-day treatment cycles
15965145|NCT03149575|Drug|Physician's Choice of Salvage Therapy - temozolomide|"The product label for temozolomide (Temodar®) provides the following dosing information.
~Newly Diagnosed GBM: 75 mg/m2 for 42 days concomitant with focal radiotherapy followed by initial maintenance dose of 150 mg/m2 once daily for Days 1-5 of a 28-day cycle of Temodar® for 6 cycles.
~Refractory Anaplastic Astrocytoma: Initial dose 150 mg/m2 once daily for 5 consecutive days per 28-day treatment cycle."
15965180|NCT03149302|Other|LNT plus sensorimotor/balance exercises|The local neck treatment (30 minutes) plus the sensorimotor exercise program (15 minutes) and the balance exercises (15 minutes). The participants will attend 12 individual treatment sessions (2 visits per week for 6 weeks).
15965146|NCT03149575|Drug|Physician's Choice of Salvage Therapy - lomustine|"The product label for lomustine (CeeNu; lomustine; CCNU) provides the following dosing information.
~The recommended dose of lomustine in adult and pediatric patients as a single agent in previously untreated patients is 130 mg/m2 as a single oral dose every 6 weeks In individuals with compromised bone marrow function, the dose should be reduced to 100 mg/m2 every 6 weeks."
15965147|NCT03149575|Drug|Physician's Choice of Salvage Therapy - carboplatin|"The product label for (Paraplatin) carboplatin Injection provides the following dosing information.
~As a single agent at a dosage of 360mg/m2 IV on day 1 every 28 days Alternatively, the carboplatin dose may be calculated by the Calvert formula below Calvert formula for carboplatin dosing: Total Dose (mg) = (target AUC) x (GFR + 25), where AUC = area under the curve and GFR = glomerular filtration rate."
15965148|NCT03149562|Drug|plasma transfusions|These critical ill neonates with plasma transfusions
15965149|NCT03149562|Drug|non-plasma transfusions|These critical ill neonates without plasma transfusions
15965150|NCT03149549|Drug|CX-2009|CX-2009 Monotherapy
15965151|NCT03149536|Diagnostic Test|Pharmacogenetic test|To develop a pharmacogenetic prediction test
15965152|NCT03149510|Behavioral|Mobile Application|Participants will use the mobile application daily to assess heart failure symptoms.
15965153|NCT03149497|Procedure|anterior approach only in cervical spine trauma|evaluation of efficacy of single approach
15965154|NCT03149484|Device|Personal remote microphone (RM) system|Speech perception in noise performance will be evaluated in the unaided, bone conduction device (BAHA) aided, and bone conduction device (BAHA) + RM conditions. All test measures are non-experimental and commercially available.
15965155|NCT03149484|Other|Subjective Questionnaire|These subjective questionnaires will be given pre- and post-evaluation to both the subject and their guardian in order to determine the impact of RM on subject and guardian perceptions of listening in noise.
15965156|NCT03149471|Diagnostic Test|Endothelial dysfunction test|The endothelial function test will be assessed after 48 hours post admission and 1 year post discharge using the non-invasive Endo-PAT2000 device. The device is intended for use as a diagnostic aid in the detection of coronary artery endothelial dysfunction (positive or negative) using a reactive hyperemia procedure. It is based on the use of Peripheral Arterial Tone (PAT) signal technology, during a clinically established procedure, which measure post-ischemic vascular responsiveness following upper arm blood flow occlusion.
15965157|NCT03149458|Other|dance|dance program
15965158|NCT03149458|Other|control|upper limb rehabilitation
15965159|NCT03149445|Drug|Tesofensine/Metoprolol|Study medication will be administered for 91 days.
15965160|NCT03149445|Drug|Placebos|Study medication will be administered for 91 days.
15965161|NCT03149432|Procedure|Mirror Therapy|by a mirror effect the patient sees his remaining arm at the place of the amputated arm that cause an illusion of presence of this arm to the brain and would have an effect of reducing phantom pain
15965162|NCT03149432|Drug|Gabapentin|titration of Gabapentin up to 3600 mg or maximum tolerated dose for 8 weeks
15965163|NCT03149432|Procedure|Rehabilitation|Daily care with physiotherapist ; orthoprosthetists , and specialized sports educators ; if necessary : occupational therapy.
15965164|NCT03149432|Other|Local care|local care for directed healing of the stump.
15965165|NCT03149419|Drug|Paroxetine|
15965166|NCT03149419|Drug|Placebo oral capsule|
15965167|NCT03149406|Other|Comparing the expression of miRNAs|by PCR, in symptomatic and asymptomatic carotid plaques.
15965168|NCT03149393|Drug|Qizhi Weitong Granules|Patients in this group will take Qizhi Weitong Granules 2.5g,3 times/day,30 minutes before dinner for 8 weeks.
15965169|NCT03149393|Drug|Mosapride Citrate Tablets|Patients in this group will take mosapride citrate tablets 5mg,3 times/day,30 minutes before dinner for 8 weeks.
15965170|NCT03149380|Behavioral|Web-based education|The investigators will utilize interactive lessons and activities to educate about Alzheimer's disease prevention, treatment and caregiving, with focus on evidence-based lifestyle and nutritional recommendations that have been associated with delaying cognitive decline.
15965171|NCT03149367|Procedure|levator muscle resection with fixed sutures technique|The levator muscle is approached through skin incision and the muscle shortened and sutured directly to the tarsus then the skin crease reformed with interrupted sutures which pick up the underlying levator muscle
15965172|NCT03149367|Procedure|Levator muscle resection with adjustable sutures technique|The adjustable sutures technique in which the sutures passes through the levator muscle into the tarsal plate and out through the skin edge .the skin crease is formed separately so that adjusting the suture doesn't open the wound, the suture can be adjusted according to the result up to 4 days post operative.
15965173|NCT03149354|Other|Assay of TSH, FT3 and FT4 by immuno-radiometric method|Assay of TSH, FT3 and FT4 by immuno-radiometric method Determine the current prevalence of hypothyroidism in HIV-infected patients
15965174|NCT03149341|Other|Magnetic Resonance Imaging|All subjects will undergo or have already undergone Magnetic Resonance Imaging. Normal volunteers will be used for comparison with subjects. To minimize risk, normal volunteers will NOT undergo anesthesia, sedation or receive intravenous contrast during procedure.
15965175|NCT03149328|Other|Educational Support|In the intervention group, clinicians will be provided with PRO feedback for use in their clinical practice. They will also receive educational support on how to use PRO data at point of care.
15965176|NCT03149315|Drug|Ibrutinib|Ibrutinib 420mg, PO once daily for 2-7 days
15965177|NCT03149302|Other|Local neck treatment (LNT)|The local neck treatment consists of cervical mobilization and specific therapeutic exercises (30 minutes). The participants will attend 12 individual treatment sessions (2 visits per week for 6 weeks).
15965178|NCT03149302|Other|LNT plus sensorimotor exercises|The local neck treatment (30 minutes) plus the sensorimotor exercise program (15 minutes). The sensorimotor exercises include cervical joint position sense and oculomotor training. The participants will attend 12 individual treatment sessions (2 visits per week for 6 weeks).
15965179|NCT03149302|Other|LNT plus balance exercises|The local neck treatment (30 minutes) plus the balance exercise program (15 minutes).The balance program includes with static balance and progress to dynamic balance and gait. The participants will attend 12 individual treatment sessions (2 visits per week for 6 weeks).
15965181|NCT03149289|Drug|Antiviral drugs|sofosbuvir, ribavirin, daclatasvir, ledipasvir, simeprevir, paritaprevir, dasabuvir, ombitasvir
15965182|NCT03149276|Other|Interpreter services|
15965183|NCT03149263|Behavioral|distraction|Children will all benefit toxin injections with the same protocol. Only the distraction will be different during the session: either the children will have a distraction realized by the team of clowns / or children will benefit a classic distraction (TV, music, ...)
15965184|NCT03149250|Diagnostic Test|Aggregometry, Monitoring of plasmatic hemostasis|Multiple Electrode Aggregometry using the Multiplate system Coagulation factor analyses (FXIII, FVIII, vWF) Parameters of conventional coagulation testing (aPTT, INR, Platelet count)
15965185|NCT03149237|Behavioral|Couples-based services|Couples-based services, including treatment, counseling and peer mentoring in the community.
15965186|NCT03149211|Drug|UB-421|Subjects will receive 13 doses of the UB-421 by intravenous infusion at 25 mg/kg bi-weekly (Cohort 2, 26 weeks).
15965187|NCT03149211|Drug|current standard HAART treatment|Subjects will receive current standard HAART treatment as the active control group.
15965188|NCT03149198|Other|Mat Pilates exercises|The exercise program based on the pilates method will be performed on the ground in the group room of the FACISA / UFRN Physiotherapy School Clinic in Santa Cruz. The room has ample space and air conditioning for better patient accommodation. The exercises will be performed twice a week for 12 weeks. Each session will last about 50 minutes and will be supervised by a physical therapy student along with the research coordinator. A total of 10 exercises will be performed.
15965189|NCT03149198|Other|Aquatic aerobic exercises|"The aerobic exercise program will be held in the therapeutic pool of the Physiotherapy School Clinic of FACISA / UFRN in Santa Cruz. The pool is heated and provides better effects to the proposed treatment.
~The exercises will be performed twice a week for 12 weeks. Each session will last about 50 minutes and will be supervised by another physical therapy student along with the research coordinator."
15965190|NCT03149185|Behavioral|Technology based cognitive behavioral stress management|Intervention is delivered through Telecare (web based technology) in a group for 60-90 minutes/session. During each session, participants are taught/discuss a new anxiety/arousal reduction technique and focus on stress management. Efficacy of available treatments, disease course, symptom burden, communication with intimate partner and/or family members and health care provider, impact of stress on physical and mental health and symptoms, and management of APC and HT symptoms are used for educational purposes and as catalysts for discussing TCBSM techniques. We allow participants to describe psychosocial stressors with an emphasis on symptoms and disruption, HRQOL and their coping responses for in-session role-plays. Participants are able to access the system at any time to retrieve relaxation and stress management didactics, and contact community resources and other participants in their group.
15965191|NCT03149185|Behavioral|Technology based health promotion group-based attention matched control condition|Sessions include content from relevant NCI, ACS and other resources developed to address the needs of advanced cancer populations into each topic session. All sessions address APC-specific issues. While men receiving treatment for APC remain interested in general health issues and as they become increasingly aware of the end-of-life issues raised by facing advanced disease, they seem to be interested in making life changes in areas in which they do exercise control (e.g., nutrition), and as such have been integrated into the T-HP modules in addition to general recommendations from sources such as American Heart Association, the NIA and the ACS. T-HP participants are scheduled for weekly group-based health information and promotion sessions (60-90 mins.), which are delivered via our videophones by our T-HP facilitators.
15965192|NCT03149172|Device|Equimatrix®|Ridge preservation bone grafting after tooth extraction
15965193|NCT03149172|Device|Bio-Oss®|Ridge preservation bone grafting after tooth extraction
15965194|NCT03149172|Device|Endobon®|Ridge preservation bone grafting after tooth extraction
15965195|NCT03149159|Drug|Nivolumab|Nivolumab will be given every 21 days for the first 12 weeks at a dose of 3mg/kg. After 12 weeks, the dose will be 240mg and will be given every 14 days.
15965196|NCT03149159|Drug|Ipilimumab|Ipilimumab will be given at a dose of 1mg/kg every 21 days for up to 12 weeks.
15965197|NCT03149159|Radiation|Steriotactic radiation therapy|The dose of radiation will be 6 Gy daily x 5 days. Radiation will be given between the first and second doses of ipilimumab plus nivolumab.
15965198|NCT03149146|Other|Clinical Decision Making (CDM) Workshop|Participants will be provided the Clinical Decision Making workbook which will be used as a guideline to practice decision making. A workshop was chosen rather than other methods of presenting the guideline so that participants could receive feedback and guidance from the instructors and from the other participants. Active learning educational environment will be encouraged and the workshop require group and individual participation and also assist the participants in reflection on their decisions.
15965199|NCT03149146|Other|Clinical Decision Making (CDM) Workbook|Participants are encouraged to read and do exercises which was written in the workbook for a week and they also are asked to recall their recent patient case or use their patient as the example case and answer the questions from the Clinical Decision Making workbook.
15965200|NCT03149133|Other|Heavy hypertrophy training|Training with 75-80 % of 1-RM
15965201|NCT03149133|Other|Light hypertrophy training|Training with 35-50 % of 1-RM
15965202|NCT03149120|Biological|Nivolumab|Nivolumab will be given as an intravenous infusion at a dose of 240 mg every 2 weeks for at least 6 months.
15965203|NCT03149120|Drug|Pazopanib|Pazopanib given at a dose of 800 mg by mouth daily.
15965204|NCT03149107|Drug|N-Acetylcysteine|N-Acetylcysteine (2000 mg/d, 1000 mg in the morning/evening, oral intake). Will be applied continously over 26 weeks parallel to the psychological intervention (IPPI or PSM).
15965205|NCT03149107|Drug|Placebo|Will be applied continously over 26 weeks (oral intake of capsules) parallel to the psychological intervention (IPPI or PSM).
15965206|NCT03149107|Behavioral|IPPI (Integrated Preventive Psychological Intervention)|IPPI (Integrated Preventive Psychological Intervention): 21 sessions, the first 20 sessions are scheduled weekly, the last session two weeks after session 20. Single blinded (statistician & rater)
15965207|NCT03149107|Behavioral|PSM (Psychological stress management)|PSM (Psychological stress management): 11 sessions; the first 10 sessions will be offered biweekly, the last one 2 weeks after session 10. Single blinded (statistician & rater).
15965208|NCT03149094|Behavioral|CBSM-SMI|The intervention group will receive Cognitive Behavioral Stress Management (CBSM) for Individuals Living with HIV via mHealth through smartphones and tablets.
15965209|NCT03149094|Behavioral|CBSM-SMI control|this group will receive the LifeSum app.
15965210|NCT03149081|Drug|Boswellia|Boswellia is an extract from frankincense
15965211|NCT03149055|Drug|Isavuconazole|Intravenous or oral: Isavuconazonium sulfate 372 mg Q 8hour for 6 doses as loading dose, followed by 372 mg Q day as maintenance dose.
15965212|NCT03149042|Diagnostic Test|CCTA|Diagnostic Test
15965216|NCT03149016|Procedure|Corticotomy-assisted Retraction|Using a tunneling technique, the researcher will perform the intervention in the alveolar bone surrounding the upper incisors before retraction.
15965217|NCT03149003|Drug|DSP-7888 Dosing Emulsion|DSP-7888 Dosing Emulsion will be administered i.d. every 7 ± 1 day for Doses 1 to 5, every 14 ± 3 days for Doses 6 to 15, and every 28 ± 7 days for Doses 16 and above.
15965218|NCT03149003|Drug|Bevacizumab|Bevacizumab will be administered intravenously every 14 ± 3 days at 10 mg/kg.
15965219|NCT03148990|Biological|Measles and Rubella vaccine|Administration of the experimental vaccine (MR).
15965220|NCT03148990|Biological|Measles, Mumps and Rubella vaccine|Administration of the comparator vaccine (MMR).
15965221|NCT03148977|Procedure|Graft|Autogenous skin grafting is the only definitive treatment for the full thickness burn injuries, and thus represents the centerpiece of modern burn care.
15965222|NCT03148964|Biological|blood sampling|Blood Sampling at J0, M1, M3, M6, M12, M24 and every 12 months until the end of the study
15965223|NCT03148938|Other|Digital Assessment on mobile|"The digital assessment is composed on 4 tests:
~walking test
~coordination test
~attention test
~vision test"
15965224|NCT03148925|Biological|SELA-070|Sub-cutaneous injection, multiple dose
15965225|NCT03148925|Biological|Saline|Sub-cutaneous injection, multiple dose
15965226|NCT03148912|Diagnostic Test|Diagnostic algorithm|The treating physician will complete an enrollment assessment including the 4T score pretest probability assessment14. All patients will have laboratory testing for HIT anti-PF4 as well as SRA testing. Results of the anti-PF4 assay (OD value) will be available to the treating physician who will be instructed to follow the study diagnostic algorithm
15965227|NCT03148899|Drug|Oxytocin Intranasal Spray|In human volunteers intranasal administration of oxytocin significantly increases parasympathetic and decreases sympathetic cardiac control. In addition to the classic effects of oxytocin on uterine contraction and milk ejection, recent work indicates oxytocin is present in both males and females and has an important role in both behavior and cardiovascular homeostasis, particularly during anxiety and stress.
15965228|NCT03148899|Drug|Placebo Intranasal Spray|The placebo has been compounded to be an inactive, blinded comparative to the oxytocin nasal spray.
15965229|NCT03148886|Other|PA intervention|"The program is individualized according to age, fitness level, place of residence, access to adapted specific training group or associations, PA preferences and wishes of each participant. Patients are informed of the recommendations in terms of PA, and the target of 150min per week in order to maintain health benefits. Patients are asked to walk at least 30 minutes per day and increase their activities into daily routine. Several individual strategies are established with the patients to attain their objectives and increase their daily life PA.
~Withings® PA trackers have been used to provide an incentive effect to increase PA, to measure the number of steps per day and make people think about their PA. Patients wore a Withings Go® wristband PA tracker throughout the whole study and had in real time a feedback on their number of steps per day.
~A 7 mL blood sample is collected at baseline (D1) and at the end of the 6-month study (M6) for the biological study."
15965230|NCT03148873|Device|RespiraSense patient respiratory monitor system|Subjects will have their respiratory rate monitored for two hours using three different methods for capturing it
15965231|NCT03148860|Drug|Methotrexate|subjects will receive once weekly 15 mg (3 capsules) MTX
15965232|NCT03148860|Drug|Ustekinumab|subject will receive Ustekinumab open-label over a treatment period of 52 weeks
15965233|NCT03148860|Other|Placebo|subjects will receive once weekly 3 capsules PLC to MTX
15965234|NCT03148847|Other|Baseline care|
15965235|NCT03148847|Other|Referential's dissemination|
15965236|NCT03148834|Procedure|Controlled Reperfusion|"Patients will be treated in the occluded coronary with a solution of venous blood and Dextran, prior to the Stenting procedure.
~Controlled Reperfusion PCI consists of crossing the culprit lesion with guidewire and then advancing a balloon (over the wire) to the distal segment of the culprit vessel. Proximal to the main distal branch, inflate the balloon to low atmospheres, remove the guide wire and inject the solution through the light of the balloon. Then reposition the guidewire, perform angioplasty as usual on the lesion. If there is a large residual thrombus load and at the operator's discretion, change the balloon by a manual thromboaspiration catheter and use it.
~Then perform stenting of the lesion. The solution will be given with a 1 cc syringe as a slow bolus, controlling symptoms and ST segment response.
~The compounds in solution are venous blood drawn from the patient after administration of heparin and mixed with dextran in a 3/1 ratio."
15965237|NCT03148808|Combination Product|NVS Therapy|Combination Product: NVS Therapy which includes NVS Injection (investigational product) and the following investigational devices: NVS Delivery Catheter, NVS Light Fiber, and NVS Light Source.
15965238|NCT03148795|Drug|Talazoparib|1 mg daily
15965239|NCT03148782|Behavioral|OST Intervention for participants with Organizational skill difficulties|Will undergo two magnetic resonance imaging (MRI) sessions: one within 2 weeks prior to OST treatment and one within 2 weeks of completion of the OST treatment.
15965240|NCT03148756|Drug|Dalbavancin|Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1, and on Day 8.
15965241|NCT03148756|Drug|Standard of Care|Antibiotic consistent with Standard of Care (SOC), based on baseline pathogen, for 4 to 6 weeks.
15965242|NCT03148743|Biological|Fecal microbiota|fecal microbiota transplantation
15965243|NCT03148730|Device|closed-loop group|Use of 3 indenpendent closed-loop systems to deliver the propofol, remifentanil, fluid and to adjust ventilation
15965244|NCT03148717|Drug|Misoprostol|Cytotec
15965245|NCT03148717|Other|Placebo|Placebo tablet similar in shape, odour and consistency to misoprostol tablet.
15965289|NCT03148431|Drug|Placebo|Administered IV
15965396|NCT03147469|Procedure|Extension|After changing the position of head and neck of subjects to extension, the variables were measured.
15965246|NCT03148704|Drug|palonosetron hydrochloride capsules|Collect all the patients' safty and efficacy data as long as they use palonosetron hydrochloride capsules(Ruo Shan®) .Specific methods of using the drugs are not limited .
15965247|NCT03148691|Drug|A-101|Topical Solution
15965248|NCT03148678|Behavioral|Mindfulness|Subjects are provided with smartphone-based mindfulness intervention.
15965249|NCT03148678|Other|Contingent RT-fMRI-NF|Subjects are provided with contingent RT-fMRI-NF of their own brain activity.
15965250|NCT03148678|Other|Sham RT-fMRI-NF|Subjects are provided with sham RT-fMRI-NF of brain activity of previously recorded subject.
15965251|NCT03148678|Behavioral|Mind Wandering|Subjects are provided with smartphone-based mind wandering intervention.
15965252|NCT03148665|Device|OncAlert|A noninvasive point of care salivary rinse test performed as 1) a one-time test for control subjects, 2) at pretreatment and post treatment 3,6, 12, and 18 month time points in oral cavity/oropharynx cancer patients
15965253|NCT03148652|Other|Enhanced Intervention Condition|The intervention incorporates 1) a standard, evidence-based cognitive behavioral therapy-based smoking cessation program, 2) working memory training, and 3) a motivational enhancement component. Working memory training will be administered via the computerized program Cogmed QM. Investigators will be able to monitor participants' progress throughout the study, using the data that the program gathers.
15965254|NCT03148639|Behavioral|Avatar therapy|Patients will receive 6 sessions of avatar therapy consisting of 45 minute (1 session per week). The therapy will consist in prompting patients to enter in a dialogue with their persecutor to better regulate their emotional responses. Over the course of the therapy, the character of the avatar will progressively become under patients' control. More precisely, the avatar's speech and tone will gradually be changed by the therapist to echo patients' improved ability to regulate their emotions. That is, the avatar will progressively change from being abusive to becoming helpful and supportive. By doing so, the therapy will seek to reinforce patients' feeling of empowerment over their voices.
15965255|NCT03148639|Other|Treatment-as-usual|Treatment as usual will consist of typical or atypical antipsychotic medication and regulars appointments with psychiatrists and others care team members for a period of 6 weeks.
15965256|NCT03148626|Other|MINDI mindfulness curriculum|A seven-session mindfulness curriculum implemented over six-months during pediatric internship.
15965257|NCT03148626|Other|Control|Usual Education
15965258|NCT03148600|Behavioral|Pelvic floor and bowel behavioural training|Physiotherapist-led pelvic floor muscle and bowel behavioural training
15965259|NCT03148600|Other|Standard arm|Standard medical and nursing care
15965260|NCT03148587|Behavioral|Self-assessment: MLPT|Patients enrolled in the study will self-assess the outcomes of their medical abortion using the multi-level pregnancy test.
15965261|NCT03148587|Behavioral|Self-assessment: LSPT|Patients enrolled in the study will self-assess the outcomes of their medical abortion using the low sensitivity pregnancy test.
15965262|NCT03148574|Drug|Misoprostol|intrauterine tablets
15965263|NCT03148574|Drug|Oxytocin|intravenous
15965264|NCT03148561|Drug|Misoprostol|received misoprostol 800 µg (Misotac 200 µg tablets, SIGMA pharmaceutical) once dose vaginally
15965265|NCT03148548|Genetic|thrombophilia screening|genetic Evaluation of Factor-V-Leiden, Factor-II_G20210A Mutation;
15965266|NCT03148535|Drug|Lithium Carbonate|bipolar depression recieve lithium Carbonate treatment
15965267|NCT03148535|Drug|lithium carbonate combined with SSRI antidepressant treatment|lithium carbonate combined with SSRI antidepressant treatment
15965268|NCT03148522|Drug|Escitalopram|receive escitalopram
15965269|NCT03148522|Drug|Duloxetine|receive duloxetine
15965270|NCT03148522|Drug|Mirtazapine|receive mirtazapine
15965271|NCT03148509|Drug|risperidone|DA receptor-mediated drugs
15965272|NCT03148509|Drug|aripiprazole|DA receptor-mediated drugs
15965273|NCT03148509|Drug|bupropion|DA receptor-mediated drugs
15965274|NCT03148496|Device|Biologic Mesh|Biologic mesh placed during surgery
15965275|NCT03148496|Procedure|Small Bytes|0.5 cm x 0.5 cm sutures used
15965276|NCT03148496|Procedure|Large Bytes|1.0 x 1.0 sutures used
15965277|NCT03148483|Other|Early PT|Women will receive conventional non-surgical periodontal therapy (PT), consisting of prophylactic dental polishing to remove the sticky bacterial film that forms on the teeth over time, scaling and root planing, as necessary throughout pregnancy, up to delivery
15965278|NCT03148483|Other|Delayed PT|Women will receive conventional non-surgical PT delayed until after delivery.
15965279|NCT03148483|Dietary Supplement|Fortified Milk|participants will be advised to take two servings of a powdered milk-based drink enriched with calcium and vitamin D daily during breakfast and afternoon snack or supper to avoid concomitant intake of the prenatal iron supplements routinely prescribed for consumption with hot main meals (e.g. lunch or dinner). Women will be advised to consume 20 g of commercially available semi-skimmed milk powder (provided by the study) and one sachet with 500 IU of vitamin D3 and 1,2 g of a calcium supplement from milk extract (300 mg of calcium) twice a day.
15965280|NCT03148483|Dietary Supplement|Plain Milk|Women will be advised to consume 20 g of commercially available semi-skimmed milk powder (provided by the study) and one sachet with flour (placebo).
15965281|NCT03148470|Device|Sham iTBS|Placebo stimulation for the iTBS group
15965282|NCT03148470|Device|Sham cTBS|Placebo stimulation for the cTBS group
15965283|NCT03148470|Device|intermittent theta burst stimulation (iTBS)|Excitatory theta burst stimulation
15965284|NCT03148470|Device|continuous theta burst stimulation (cTBS)|inhibitory theta burst stimulation
15965285|NCT03148457|Drug|Early treatment with Rivaroxaban (Xarelto®), Dabigatran (Pradaxa®), Apixaban (Eliquis®) or Edoxaban (Lixiana®)|Early treatment will be started within 48 hours after symptom onset (minor and moderate ischaemic stroke) or at day 6 + 1 day after symptom onset (major ischaemic stroke)
15965286|NCT03148457|Drug|Late treatment with Rivaroxaban (Xarelto®), Dabigatran (Pradaxa®), Apixaban (Eliquis®) or Edoxaban (Lixiana®)|Patients in the control arm will receive late treatment as per current recommendations (i.e. minor ischaemic stroke after day 3 + 1 day, moderate ischaemic stroke after day 6 + 1 day and major ischaemic stroke after day 12 + 2 day).
15965287|NCT03148444|Drug|cefalexin 500 mg qid or roxithromycin 150 mg bid|antibiotics treatment for five days following implantation of cardiac device
15965288|NCT03148431|Drug|LY3002815|Administered IV
15965290|NCT03148418|Drug|Atezolizumab|Atezolizumab will be administered as monotherapy or combined with other agent(s) or comparator agent(s) in a Genentech or Roche-sponsored study (the parent study). Dosing regimen will be in accordance with the parent study and local prescribing information.
15965293|NCT03148366|Drug|Levofloxacin based sequential therapy|D1-D7: (esomeprazole 40mg bid + amoxicillin 1gm bid) for 7 days D8-D14: (esomeprazole 40mg bid + levofloxacin 250mg bid + metronidazole 500mg bid) for another 7 days
15965294|NCT03148366|Drug|bismuth quadruple therapy for 10 days (BQ)|D1-D10: (esomeprazole 40mg bid + Dibismuth trioxide 120mg qid + metronidazole 500mg tid + tetracycline 500mg qid) for 10 days
15965295|NCT03148353|Procedure|Subacromial injection|"Modified ultrasound guided corticosteroid subacromial injection
~Standardized ultrasound guided corticosteroid subacromial injection"
15965296|NCT03148340|Diagnostic Test|VIPS Monitoring|Bioimpedance asymmetry
15965299|NCT03148314|Drug|vaginal misoprostol|(800µgm.x 2 doses 3 hours).
15965300|NCT03148314|Drug|buccal/sublingual misoprostol|200 µgm.x4 hrs.x 6 doses
15965301|NCT03148301|Other|Survey|Survey
15965302|NCT03148288|Dietary Supplement|Vitamin D|VItamin D
15965303|NCT03148288|Dietary Supplement|placebo|placebo
15965306|NCT03148262|Device|The Comfort Flo system|The Comfort Flo system will be used for the high flow nasal cannula during procedural sedation
15965307|NCT03148262|Device|The Salter nasal cannula|A Salter nasal cannula will be used at 4L/ minute during the procedural sedation.
15965308|NCT03148249|Other|interview|control group: interview, study group: explanation and exploration
15965309|NCT03148236|Drug|Vitamin C|200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W
15965310|NCT03148236|Other|Placebo|50mL infused over 30 minutes
15965311|NCT03148223|Device|auriculotherapy|The participants will be submitted to a session per week with duration of 20 minutes, for three consecutive months, to fix the adhesives. The points selected for stimulation, according to Chinese atrial mapping, are: uterus, endocrine, ovary, pituitary, shen men, sympathetic, and liver. Participants will be advised to remain with the stickers fixed to the auricle for six days.
15965312|NCT03148210|Drug|Treatment strategy using evidence-based guidelines for asthma or COPD|The respirologist will determine the clinical extent of the patient's symptoms, activity limitation, and degree of airflow obstruction and will commence the subject on asthma or COPD medications if indicated
15965313|NCT03148210|Behavioral|Smoking Cessation|Smoking cessation counselling by a qualified educator if currently smoking
15965314|NCT03148210|Behavioral|Participant Education|Standardized education for asthma or COPD disease
15965315|NCT03148184|Diagnostic Test|shoulder x-ray|post operative shoulder x-ray at minimum 2 year post op
15965316|NCT03148171|Other|WERK Supportive Contact|Provide emotional support and practical support. Support friend/family by helping him to stay engaged in PrEP Care.
15965317|NCT03148158|Device|Cystoscopy|Outpatient flexible cystoscopy and inpatient rigid cystoscopy
15965318|NCT03148145|Behavioral|Step Goal Delivery by Smartphone|Step Goal Delivery by Smartphone
15965319|NCT03148145|Behavioral|Message Delivery by Smartphone|Message Delivery by Smartphone
15965320|NCT03148132|Drug|Bevacizumab Injection|0.5mg/0.02 mL
15965321|NCT03148132|Drug|Ranibizumab Ophthalmic|0.25mg/0.025 mL
15965322|NCT03148119|Drug|QRH-882260 Heptapeptide|topical spray; fluorescently-labeled peptide composed of a 7-amino acid sequence [Gln-Arg-His-Lys-Pro-Arg-Glu] attached via a 5 amino acid linker [Gly-Gly-Gly-Ser-Lys] to a near-infrared fluorophore, Cy5. The complete peptide sequence is written as: Gln-Arg-His-Lys-Pro-Arg-Glu-Gly-Gly-Gly-Ser-Lys(Cy5)-NH2, and is abbreviated as: QRHKPRE-GGGSK-(Cy5)-NH2.
15965323|NCT03148119|Device|Scanning Fiber Endoscope|Endoscope used for providing the light via laser to image the area of interest in the colon after the QRH has been sprayed and rinsed.
15965324|NCT03148106|Device|Somatosensory Electrical Stimulation|We will put adhesive electrodes on the affected arm and connect it to a device that will deliver a gentle electrical stimulation to the hand and arm. The stimulation will last for different amounts of time, depending on the stimulation condition. This can be 30 minutes twice a day (1 hour apart), 1 hour continuously, 2 hours continuously, or 3 hours continuously. The stimulation conditions will also vary in stimulation strength. It is normal that some people may feel a tingling sensation, while others may feel nothing.
15965325|NCT03148080|Procedure|Cognitive Assessment|Complete CogState
15965326|NCT03148080|Other|Questionnaire Administration|Complete Self-Report Questionnaire
15965327|NCT03148067|Procedure|Intramedullary nailing for fracture fixation|
15965328|NCT03148054|Device|Computer Tomography and Endoscopy|"Pelvic CT scan with i.v. and rectal contrast (Siemens Healtheneers, Erlangen, Germany) with the following scan parameters: collimation 0.6 mm, pitch 1.2 mm, CareKV with reference 120 mAs and reference 120 kV, rotation time 0.5 sec. Portal venous phase (individually tailored contrast media injection of Xenetix 300, Guerbet GmbH) and rectal contrast (500cc: 470cc water + 30cc Telebrix® gastro, a water soluble iodinated contrast agent, Guerbet GmbH).
~Endoscopy takes 5 minutes: A gastroscope with a diameter of 10mm is used for inspection of anus, rectum, anastomosis incl. measurements (distance to dentate line, diameter of anastomosis) and distal part of colon (to rule out ischemia) during short term insufflation of the rectum with CO2. No biopsies are taken. Digital photo documentation will be provided. In case of anastomotic insufficiency: optional sedation of patient and clip closure with endoscopic OTSC (over the scope clip) system."
15965360|NCT03147690|Drug|Lumason|Lumason will be administered at a dose of 0.03 mL/kg up to a maximum dose of 2.4mL injected into a peripheral intravenous catheter. An abdominal contrast enhanced ultrasound will be performed to look for solid organ injury. The will be given twice during the intervention, for a total maximum dose per subject of 4.8mL.
15965329|NCT03148041|Other|health education program|"Intensive health education program for intervention group: 1.The introductory 30 minute Arabic lecture for increase level of the awareness of the participants regarding stroke. Lecture from the USA National Stroke Association, 2011, will be used. The lecture includes the following issues about stroke (1) definition; (2) signs and symptoms; (3) risk factors; (4) treatment; and (5) prevention.
~2. Self-help materials will involve health education brochures regarding stroke and will be distributed for all participants at the time they are attending the lecture. The brochures which will be used for this study will be collected from the World Stroke Day 2016 Brochures, the Arabic version.
~The routine care for control group: different lecture and brochures will be used"
15965330|NCT03148015|Other|Biomarkers|Evaluate the intracellular and intraluminal distribution of autophagy and calcium efflux markers in each breast lesion in comparison to the HER2, proliferation (Ki-67, PCNA), p53, inflammatory, and apoptotic (Annexin-1) markers in the same patient. Determine the qualitative amount and localization of PMCA2 and Vitamin D Receptor in each breast lesion with intraductal calcium spicules compared to lesions without microcalcifications.
15965331|NCT03148002|Drug|Current Bowel Protocol (senna/lactulose)|Stimulant and Osmotic Laxatives.
15965332|NCT03148002|Drug|PEG Bowel Protocol (PEG/lactulose)|Osmotic Laxatives.
15965333|NCT03147989|Drug|MultiHance|gadolinium contrast agent
15965334|NCT03147976|Drug|AMG 337|6-{(1R)-1-[8-fluoro-6-(1-methyl-1H-pyrazol-4- yl)[1,2,4]triazolo[4,3-a]pyridin-3-yl]ethyl}-3-(2- methoxyethoxy)-1,6-naphthyridin-5(6H)-one•hydrate (1:1)
15965335|NCT03147963|Drug|Docetaxel|Docetaxel will be given until progression or patient intolerance
15965336|NCT03147950|Procedure|Prone-Flexed PCNL|Prone-Flexed Position For Percutaneous Nephrolithotomy (PCNL)
15965337|NCT03147950|Procedure|Prone PCNL|Prone Position For Percutaneous Nephrolithotomy (PCNL)
15965338|NCT03147937|Other|Cognitive Testing|Computerized CogState Brief Battery (CBB), Cognigram, assesses changes in four cognitive domains including psychomotor function, attention, learning and memory, and working memory. The CBB is a computerized test based on card games that can be administered online
15965339|NCT03147924|Other|Improvisation Group|The aim of this pilot study is to investigate the effects of improvisational comedy in a group of help-seeking youth at risk of developing a range of mental health disorders, including social anxiety.
15965340|NCT03147885|Drug|Selinexor|Given PO
15965341|NCT03147872|Other|2% Oxygen|2% oxygen concentration in the incubator in which embryos are being cultured after day 3 of development
15965342|NCT03147859|Biological|Vedolizumab (brand name Entyvio)|IV infusion
15965343|NCT03147846|Procedure|delayed cord clamping|delay of cord clamping for 60 seconds
15965344|NCT03147846|Procedure|cord milking|active cord milking 5 times
15965345|NCT03147833|Dietary Supplement|Sport beverages Protein|Beverage ingested before each night sleep during the intervention
15965346|NCT03147833|Dietary Supplement|Sport beverages Carbohydrate|Beverage ingested before each night sleep during the intervention
15965347|NCT03147807|Device|betaLACTA® rapid diagnostic test|Since ≥1 bacteriological sample(s) from ICU patients empirically treated with carbapenems (i.e. respiratory sample such as quantitative tracheobronchial aspirate with available volume ≥1 mL; urinary sample such as single catheter urine specimen; or blood culture) is positive for ≥2 GNB/field on direct examination, empirical carbapenem will be adapted: 1) early, since the second dose, according to the results of the betaLACTA® rapid diagnostic test (BLT) in the intervention arm (i.e. de-escalation to cefepim or to ceftazidim+amikacin in case of negativity, and carbapenem continuation in case of positivity); or 2) after 48-72h according to the results of the antibiotic susceptibility test in the control arm.
15965348|NCT03147794|Device|MyndMove|A new technology system called MyndMove has been developed by MyndTec Inc. (Missisauga Canada) to administer FES. The purpose of this technology is to improve voluntary upper limb (hand and arm) function (i.e. reaching and grasping) for patients with hemiparesis as a results of stroke or spinal cord injury (7). It is a non-invasive application that delivers electrical stimulation to the affected limb transcutaneously. MyndMove has been licensed by Health Canada and is indicated as a functional electrical stimulator for improvement of arm and hand function and active range of motion in patients with hemiplegia due to stroke or upper limb paralysis due to C3-C7 spinal cord injury.
15965349|NCT03147781|Device|True AT with magnetic pellets|Magnetic pellets are affixed onto pre-selected auricular acupoints with tape.The treatment was initiated within 4 to 8 hours post cesarean for 96 hours during the hospital stay.
15965350|NCT03147781|Device|Sham AT with Medulla Junci|Medulla Junci segments are crumbled into ball-shape and then attached to the pre-selected auricular acupoints with tape. The treatment was initiated within 4 to 8 hours post cesarean for 96 hours during the hospital stay.
15965351|NCT03147768|Device|Distal Pancreatectomy Sealing Using LTW|The device's intended use is to seal the pancreatic surface using a laser to weld human albumin based biomaterials after surgical removal of pancreatic tumors during a partial pancreatectomy.
15965352|NCT03147755|Other|No intervention|No intervention
15965353|NCT03147742|Drug|Ruxolitinib|Ruxolitinib starting dose level 10 mg orally, twice daily (BID).
15965354|NCT03147729|Radiation|Radiofrequency non ablation|Use of radiofrequency
15965355|NCT03147716|Other|Enrollment Flyer|Enrollment flyer that provided information about the Triple P Positive Parenting Program and an enrollment form.
15965356|NCT03147716|Other|Testimonial Booklet|Booklet that included quotes and photos from parents who had previously participated in the Triple P Positive Parenting Program and/or their children who participated in the free childcare, as well as an enrollment form.
15965357|NCT03147716|Other|Teacher Endorsement|Brief conversation between the parent and their child's teacher in which the teacher told the parent about the benefits of participating in the Triple P Positive Parenting Program and recommended that the parent attend. The teacher also gave the parent a brochure that gave information about the Triple P program and an enrollment form.
15965358|NCT03147716|Other|Provider Engagement Call|This was a manualized, 15-minute call from the Triple P Positive Parenting Program provider to a parent in which the provider elicited the parent's child-focused goals and showed how the parent's goals could be addressed by Triple P. The provider also helped the parent anticipate and problem solve possible barriers to attendance.
15965359|NCT03147703|Behavioral|Food Timing|the timing of the main meal of the day (lunch in Spain) is changed from early (14:00) to late (17:30) and viceversa in a randomized and crossover way
15965361|NCT03147677|Drug|Alfacalcidol|
15965364|NCT03147625|Behavioral|SHAPE Intervention|SHAPE seeks to identify, equip and strengthen resources in elderly residing in elderly-only households. The content will be further developed according to the findings of an existing descriptive qualitative study, literature review and a multi-disciplinary expert panel review. The home visit will involve assessment, observation and evaluation of elderly' health status, lifestyle and home environment, followed by guidance on health-promoting behaviour and emphasis on strengthening inner health resources. This provides an individualized approach to enhance personal health skills. Group-based activity sessions are directed to facilitate group interaction among peers as well as equipping and enhancing external resources.
15965365|NCT03147612|Biological|Blinatumomab|Given via central catheter
15965366|NCT03147612|Drug|Cyclophosphamide|Given IV
15965367|NCT03147612|Drug|Cytarabine|Given intrathecally or IV
15965368|NCT03147612|Biological|Filgrastim|Given SC
15965369|NCT03147612|Drug|Methotrexate|Given intrathecally or IV
15965370|NCT03147612|Biological|Pegfilgrastim|Given SC
15965371|NCT03147612|Drug|Ponatinib|Given PO
15965372|NCT03147612|Biological|Rituximab|Given IV
15965373|NCT03147612|Drug|Vincristine|Given IV
15965374|NCT03147599|Drug|Coloverin|Mebeverine hydrochloride 135 mg
15965375|NCT03147599|Drug|Placebo|Placebo
15965376|NCT03147586|Drug|Bio-tech and omega-3 plus|immune nutrition : Bio-tech ( multivitamins and essential amino acids), and omega-3 plus (omega-3 fatty acids)
15965377|NCT03147586|Drug|placebo|placebo
15965378|NCT03147573|Diagnostic Test|1-hour blood pressure monitoring (1BPM)|This method consists of performing blood pressure measurements programmed at 5-min intervals over 1 hour. Two extra recordings taken at the start and end of this period are discarded. Blood pressure is measured in a quiet room at the same health centre.
15965379|NCT03147573|Diagnostic Test|24-hour ambulatory blood pressure monitoring (ABPM)|The device is programmed to record the participant's BP every 20 min and 30 min during the day and night, respectively. Participants are advised to carry on with their normal daily activities, avoiding any intense physical exertion, and to remain at rest when their BP is being measured.
15965380|NCT03147573|Diagnostic Test|Office blood pressure measurement (OBPM)|Two readings were made one minute apart with a validated automatic sphygmomanometer in a sitting position after five minutes of rest. The average of two readings is calculated. The procedure is repeated during 3 office visits at least a week apart.
15965381|NCT03147573|Diagnostic Test|Home blood pressure monitoring (HBPM)|For each blood pressure recording, at least two consecutive measurements should be taken, at least one minute apart. Blood pressure should be recorded twice daily, ideally in the morning and evening. Blood pressure recording should continue for at least four consecutive days, ideally seven. The average of the above readings should be calculated, ignoring the first day.
15965382|NCT03147560|Biological|Sabin IPV+ bOPV+ bOPV|Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose.
15965383|NCT03147560|Biological|Sabin IPV + Sabin IPV + bOPV|Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose.
15965384|NCT03147560|Biological|Sabin IPV + Sabin IPV + Sabin IPV|Give 3 doses of polio vaccine at 2, 3 and 4 months of age, get 2 blood samples (1.5ml per sample) before the first dose and 28-35 days after the last dose. sIPV was given 0.5ml per dose and bOPV was given 0.1ml per dose.
15965385|NCT03147547|Other|Promotional Brochure|Promotional brochure with information about the Triple P Positive Parenting Program and an enrollment form.
15965386|NCT03147547|Other|Family Testimonial Flyer|Flyer that included quotes and photos from parents who had previously participated in the Triple P Positive Parenting Program and/or their children who participated in the free childcare.
15965387|NCT03147547|Other|Teacher Endorsement|Brief conversation between the parent and their child's teacher in which the teacher told the parent about the benefits of participating in the Triple P Positive Parenting Program and recommended the parent attend.
15965388|NCT03147547|Other|Provider Engagement Call|This was a manualized, 20-minute call from the Triple P Positive Parenting Program provider to a parent in which the provider elicited the parent's child-focused goals and showed how the parent's goals could be addressed by Triple P. The provider also helped the parent problem solve barriers to attendance and develop an action plan to handle common barriers (e.g., scheduling conflicts) as well as set session reminders.
15965389|NCT03147534|Device|InstaTemp MD|The InstaTemp MD is a hand held electronic infrared thermometer that is intended to accurately measure human body temperature without contact with the human body.
15965390|NCT03147534|Device|"Welch Allyn, rectal"|"The Welch Allyn rectal thermometer is intended to measure human body temperature."
15965391|NCT03147534|Device|"Welch Allyn, oral"|"The Welch Allyn oral thermometer is intended to measure human body temperature."
15965392|NCT03147534|Device|Covidien, tympanic|The Covidien tympanic thermometer is intended to measure human body temperature.
15965393|NCT03147521|Other|Care bundle|Risk fall assessment at hospital admission with Conley scale or with findings of specific risk characteristics (previous falls, cognitive impairment, neuropsychological damage, increased need to go to the bathroom for increased evacuative needs, neuroleptic or cardiovascular drugs assumption); if risk is found shear the information with the team, writing it in patient chart, and positioning a specific symbol on patient bed. Inform patient and family about fall risk and ask, if possible, a continuous caregiver presence. Universal strategy application for the environmental safety and patient safety. Periodic assessment of drugs therapy, with the aim of reduce those that acts on central nervous system and cardiovascular system. If patient is at risk and alone, verify each 2 hours the need to go to the bathroom, change position or drink.
15965394|NCT03147495|Diagnostic Test|Standing anteroposterior knee radiographs and special proximal tibiofibular joint radiograph.|Standing anteroposterior knee radiographs and special proximal tibiofibular joint radiographs will be taken for the participants in both groups. The standing anteroposterior knee radiographs will be obtained with the knee extended. The proximal tibiofibular joint radiographs will be acquired with the knee of the participants in approximately 45°-60° of internal rotation.
15965395|NCT03147469|Procedure|Flexion|After changing the position of head and neck of subjects to flexion, the variables were measured.
15965397|NCT03147469|Procedure|Right rotation|After changing the position of head and neck of subjects to right flexion, the variables were measured.
15965398|NCT03147456|Dietary Supplement|(Cubitan Protein, Nutricia, Netherlands).|Supplement contains (per 200 ml can) 20 g of protein, 250Kacl plus different micronutrient and macronutrient.
15965399|NCT03147456|Dietary Supplement|(preOp, Nutricia, Netherlands).|contains per can (200 ml), 0g protein, fat free, 100 kcal and enriched with electrolytes
15965400|NCT03147443|Drug|Individualized Decoction|Applied in the Tested Drug Observation Period. It is the highly individualized treatment of traditional Chinese medicine,the modification of Bronchiectasis Stabilization Decoction(Radix Lithospermi 15 g, Rhizoma Fagopyri Cymosi 30 g, Radix Ophiopogonis 15 g, Poria cocos 15 g, Radix Astragali 20 g, Rhizoma Bletillae 10 g, Platycodon grandiflorum 10 g, and Semen Coicis 30 g) based on syndrome differentiation. For example,for patients with qi and yin deficiency syndrome, we added Radix Adenophorae, and Radix Rehmanniae Recens. Besides, the herbs in a prescription could be changed according to different symptoms of individual patients.
15965401|NCT03147443|Drug|placebo|Applied in the placebo Observation Period. Placebo is made by dextrin, bitter agent, edible pigment etc and added 5% test drug. The test drug and control drug have no differences in dosage form, appearance, color, specification, label, and so forth.
15965402|NCT03147443|Drug|Tested drug minus heat-clearing herbs|It is the decoction of the Syndrome Differentiation Decoction(tested drug) minus heat-clearing herbs. For example, heat-clearing herbs such as Scutellaria baicalensis or Herba Violae will be removed from the Syndrome Differentiation Decoction.
15965403|NCT03147430|Other|Biomarkers|Experimentally discover putative plasma markers for detecting early, stage I breast cancer in the setting of a suspicious mammogram and distinguish those cancers from benign lesions b) verify the putative markers through molecular profiling; and c) validate the markers by mass spectrometry.
15965404|NCT03147404|Drug|Avelumab|Avelumab 10 mg/kg i.v. every 2 weeks (Q2W)
15965405|NCT03147391|Device|LAA closure with LAmbre|Percutaneous Left Atrial Appendage Closure Using the LAmbre Device in Patients With Atrial Fibrillation
15965407|NCT03147365|Behavioral|Aerobic exercises|Aerobic exercises will do by using treadmill for children of study group A. it will consist of (max.incline15% - max. speed - heart rate grips and wireless chest strap - smooth virtual fitness trainer - smooth drop folding frame - impression shock absorption cushioning system).
15965408|NCT03147365|Behavioral|Modified strength training|Dumbbells will be used to conduct the modified strength training program for children of group B. This exercises included five exercises for the main muscle groups: bench press, leg press, seat row, leg extension and lat pull down.
15965409|NCT03147352|Device|Hyperbaric oxygen therapy|Hyperbaric oxygen therapy with 100 % oxygen at 1.8 ATA for 2 hours.
15965410|NCT03147339|Other|AGEs restricted diet|Diet modification to reduce advanced glycation end products in diet. for example to change ways of cooking, time of cooking and also omit some foods.
15965411|NCT03147326|Diagnostic Test|FDG-PET-CT|scanning method
15965412|NCT03147326|Diagnostic Test|NaF-PET-CT|scanning method
15965413|NCT03147326|Diagnostic Test|Whole-body MRI|scanning method
15965414|NCT03147313|Device|MTS Medical UG Orthogold 100|300 or 500 pulses, frequency 3Hz, energy 1 (0,1mJ/mm2)
15965415|NCT03147313|Device|Sham|Extracorporeal shock wave treatment will be faked.
15965416|NCT03147300|Behavioral|Current routine practice|Current routine practice for the primary care management of LBP
15965417|NCT03147300|Behavioral|Multifaceted implementation of the BetterBack|"The multifaceted intervention is composed of the following:
~Forming an implementation forum including head of departments/managers of the rehabilitation units and the clinical researchers.
~Forming a support team comprised of experience clinicians as local supervisors and faculty researchers as knowledge facilitators.
~Developing the Betterback model of care through a collaboration of the implementation forum, support team and international experts.
~Forming and delivering a 2-day package of education and training that the support team can utilize to assist the use of the BetterBack model of care by clinicians."
15965418|NCT03147287|Drug|Palbociclib|Palbociclib is a drug that may stop cancer cells from growing
15965419|NCT03147287|Drug|Fulvestrant|Fulvestrant prevents growth of hormone receptor positive breast cancer by blocking stimulation of cancer cells by estrogen
15965420|NCT03147287|Drug|Avelumab|Avelumab is an antibody designed to block the PD-1 pathway and helps the immune system in detecting and fighting cancer cells
15965421|NCT03147274|Behavioral|Intervention|Patients randomized to the intervention group will attend 3 SMART T1D group curriculum sessions over the study period, in addition to usual diabetes clinic care. Each interactive group session will last 2 hours and will be facilitated by a diabetes nurse educator.
15965422|NCT03147261|Other|Lifestyle intervention|Intensive changes in lifestyle with a reduced calorie mediterranean diet, physical activity and behavioral therapy
15965423|NCT03147248|Biological|CT-P13|CT-P13 (3 mg/kg) by IV infusion administered as a 2 hour IV infusion per dose every 8 weeks
15965424|NCT03147248|Biological|CT-P13|CT-P13 (90 mg) by single SC injection every other week
15965425|NCT03147248|Biological|CT-P13|CT-P13 (120 mg) by single SC injection every other week
15965426|NCT03147248|Biological|CT-P13|CT-P13 (180 mg) by double SC 90 mg injections every other week
15965427|NCT03147248|Biological|CT-P13|CT-P13 (120 mg) by single SC injection every other week with placebo IV at Weeks 6, 14 and 22.
15965428|NCT03147248|Biological|CT-P13|CT-P13 (3 mg/kg) by IV infusion administered as a 2 hour IV infusion per dose every 8 weeks with placebo SC at Week 6 and every other week thereafter up to Week 28
15965429|NCT03147235|Behavioral|vitrectomy with music listening|Those randomized to music listening will be exposed to a standardized playlist of previously validated relaxation music.
15965471|NCT03146871|Biological|Recombinant EphB4-HSA Fusion Protein|Given IV
15965472|NCT03146858|Drug|Enoxaparin|Enoxaparin is an anticlotting treatment that targets the other aspect of clot formation known as the coagulation cascade. Enoxaparin or an alternative is recommended as a single does to support PPCI procedure.
15965473|NCT03146845|Device|Allevyn Life Non-Bordered|Foam Dressing
15965474|NCT03146845|Device|Standard Care|Foam Dressing
15966102|NCT03141658|Other|Ketamine|0.23 mg/kg bolus over one minute on Screening (baseline) and Day 6
15965430|NCT03147222|Behavioral|Fracture Care at Home|This is a graduated, functionally-based intervention, paired with caregiver interactions for enhancing functional abilities. Caregivers are encouraged to have the fracture participant actively participate in their own activities of daily living and incorporate functional activities into daily routines. An intervention coach will discuss care related challenges with the caregiver to identify dependency problems, motivate the caregiver to help foster independence in the care recipient, and provide guidance in addressing behavioral symptoms associated with cognitive limitation that may occur during caregiving. The coach is guided by interventions designed by PTs, OTs, and a nurse practitioner expert in FFC. The intervention includes 1) initial assessment of participant, caregiver, and environment, 2) coaching and mentoring of caregivers regarding use of effective motivational strategies, 3) goal setting, and 4) on-going motivation and evaluation.
15965431|NCT03147209|Behavioral|Health Coaching|This intervention will consist of health coaching, goal setting and self directed activities to improve strength and balance.
15965432|NCT03147196|Drug|Bicalutamide|Given PO
15965433|NCT03147196|Other|Laboratory Biomarker Analysis|Correlative studies
15965434|NCT03147196|Other|Questionnaire Administration|Ancillary studies
15965435|NCT03147196|Drug|Raloxifene Hydrochloride|Given PO
15965436|NCT03147183|Drug|Thymoglobulin|This study will use non-probability, convenience sampling from patients kidney transplants who receive induction immunosuppressive therapy with thymoglobulin
15965437|NCT03147170|Diagnostic Test|High and low salt diets|Effects of high and low salt diets on blood pressure in individuals with normal and elevated levels of NT-proBNP
15965438|NCT03147157|Other|tacrolimus regimen guided by HLA matching rate|required low,middle and high tacrolimus concentration in high,middle and low MR group respectively
15965439|NCT03147144|Other|Ultrasonographic imaging|Ultrasound pelvic scan
15965440|NCT03147131|Procedure|Total Hip Arthroplasty|Total hip arthroplasty was randomly performed wither either a Fitmore short or a CLS straight stem.
15965441|NCT03147118|Diagnostic Test|Arthrogram|Contrast dye will be included in the standard injection of lidocaine and corticosteroid. After injection, the participant will have 2 radiograph views of the thumb.
15965442|NCT03147105|Behavioral|arm ergometry|home based arm ergometry, at least 4-5 sessions/week for 12 weeks
15965443|NCT03147092|Drug|Captopril 25Mg, Hydrochlorothiazide 25Mg Oral Tablet,|Treatment of hypertensive subjects
15965444|NCT03147092|Drug|Atenolol|Treatment of hypertensive subjects
15965445|NCT03147092|Drug|Losartan potassium 50mg|Treatment of hypertensive subjects
15965446|NCT03147092|Drug|Clonidine|Treatment of hypertensive subjects
15965447|NCT03147079|Behavioral|Lifestyle intervention|
15965448|NCT03147066|Drug|Dezocine|Dezocine (0.1 mg/kg）will be infused during surgery
15965449|NCT03147066|Drug|Flurbiprofen Axetil|Flurbiprofen Axetil (1 mg/kg）will be infused during surgery
15965450|NCT03147053|Drug|Jiedu Tongluo granules|Patients in this group were administered the Jiedu Tongluo granules, 3.9mg/bag, 2 times/day for 8 weeks.
15965451|NCT03147053|Drug|Placebo|Patients in this group were administered the placebo, 3.9mg/bag, 2 times/day for 8 weeks.
15965454|NCT03147027|Procedure|VT ablation|Substrate mapping for VT will be performed with the CARTO electroanatomical system.
15965455|NCT03147027|Other|medication|medication to prevent sustained VT and ICD therapies
15965456|NCT03147014|Biological|Maternal hyperoxygenation|approximately 10-15 minutes of maternal hyperoxygenation
15965457|NCT03147001|Other|Protein ingestion|A protein drink was ingested prior to the 90min bike ride in one of the completed trails (order randomised).
15965458|NCT03147001|Other|Non-caloric placebo ingestion|A placebo drink was ingested prior to the 90min bike ride in one of the completed trails (order randomised).
15965459|NCT03146988|Drug|RGB-02 or Neulasta® (pegfilgrastim)|Pre-filled syringe containing 6 mg RGB-02 or Neulasta® in 0.6 mL, administered as subcutaneous injection into the abdominal area
15965460|NCT03146975|Procedure|Non-surgical periodontal treatment|Quadrant-wise ultrasonic debridement followed by manual scaling and root planing under local anesthesia provided in weekly sections. Oral hygiene instructions.
15965461|NCT03146962|Drug|Vitamin C|Vitamin C infusion will be administered intravenously at 1.25 g/kg for 4 days per week for 2-4 consecutive weeks (cohort A) or up to 6 months (cohort B). Cohort C will receive high dose vitamin C for 1-3 weeks. During week 1 vitamin C infusion and Y90 radioembolization of hepatic metastases will occur same day.
15965462|NCT03146949|Device|Sorin Inspire Oxygenator|This is an oxygenator manufactured by the Sorin group. It is a hollow fibre polypropylene oxygenator.
15965463|NCT03146949|Device|Medtronic Affinity Fusion|This is an oxygenator manufactured by the Medtronic group. It is a hollow fibre polypropylene oxygenator.
15965464|NCT03146923|Other|Current Low Phosphorus Diet Prescription|"Routine / Standard Care: Routine dietary intervention is currently provided by one-to-one counselling to the subject and his/her relevant family members or carers, by a state registered dietitian regarding a diet which provides <15mg Phosphorus /g Protein (over the day). This is equivalent to approximately 1000mg P / day. This is based on the 'Eating Well with Kidney Disease' dietsheet produced by the Renal Interest Group (RIG) of the Irish Nutrition & Dietetic Institute (INDI) in 2010 and includes following main components:
~Restricting protein intake to requirements (1-1.2g/kg Ideal Body Weight)
~Restricting dairy intake (1-1.5 portions per day)
~Avoiding foods high in phosphate
~Avoiding foods with phosphate additives"
15965465|NCT03146923|Other|Modified Low Phosphorus Diet Prescription|"Modified Low Phosphorus Diet Prescription: The new prescription recommends five changes to current management
~Introduction of some plant protein in the form of pulses and nuts where the phosphorus is largely bound by phytate
~Increased focus on avoiding additives
~Introduction of more whole grains e.g. wholemeal sliced pan/ pasta/rice .
~Avoiding over-prescription of protein which carries an obligatory phosphorus load.
~Focus on high protein foods with a low phosphorus to protein ratio"
15965466|NCT03146897|Dietary Supplement|Supplementary Food|Supplementary food for treating MAM
15965467|NCT03146871|Drug|Azacitidine|Given IV or SC
15965468|NCT03146871|Drug|Decitabine|Given IV
15965469|NCT03146871|Other|Laboratory Biomarker Analysis|Correlative studies
15965470|NCT03146871|Other|Pharmacological Study|Correlative studies
15965475|NCT03146832|Behavioral|Exposure therapy (according to habituation approach)|Exposure instruction focuses on fear reduction during exposure sessions
15965476|NCT03146832|Behavioral|Exposure therapy (according to inhibitory learning approach)|Exposure instruction focuses on expectation violation during exposure sessions
15965477|NCT03146819|Device|iTotal PS Knee Replacement System|Total Knee Replacement systems (Patient Specific)
15965478|NCT03146819|Device|Off-the-Shelf Knee Replacement System|Total Knee Replacement systems (Off-the-shelf)
15965479|NCT03146806|Drug|Intranasal ketamine|"10mg of intranasal ketamine will be given to make sure that the study patients are able to tolerate a small dose of NAS ketamine.
~On the second visit, 10 mg of IV ketamine will be given to help establish bioavailability of NAS ketamine, with patients serving as their own controls.
~On the third and fourth visit, higher doses of ketamine, 30 mg and 50 mg respectively, will be given.
~All doses of ketamine will be administered by an anesthesia research nurse."
15965480|NCT03146793|Drug|Sodium Thiosulfate|25g intravenously 3 times per week
15965481|NCT03146780|Procedure|Conventional impression|"A dental impression is a negative imprint of hard (teeth) and soft tissues in the mouth from which a positive reproduction (or cast) can be form using alginate material. They are made by using a container which is designed to roughly fit over the dental arches (trays)."
15965482|NCT03146780|Procedure|Digital Scan 1|Direct intra-oral digital scans using Sirona Omnicam software.
15965483|NCT03146780|Procedure|Digital Scan 2|Direct intra-oral digital scans using Planmeca Planscan software.
15965484|NCT03146780|Procedure|Digital Scan 3|Direct intra-oral digital scans using 3M True Definition software.
15965485|NCT03146767|Device|Tetanus stabilization of baseline|Administering a Tetanic stimulus before baseline stabilization shortens the stabilization period of baseline of a neuromuscular block monitor. This acts on the baseline value
15965486|NCT03146754|Other|Methodology|No intervention will be performed. Study is designed to test methodology of lung ultrasound in accessing b lines (2 phases)
15965487|NCT03146741|Drug|Zepatier|Zepatier (grazoprevir 100mg and elbasvir 50 mg once daily) is taken by mouth for 12 weeks unless a genetic variation is detected. In this case treatment with Zepatier will be extended to 16 weeks. Study subjects with treatment failure will be provided open-label Zepatier + sofosbuvir (sovaldi) 400mg + Ribavirin (generic), renally dosed based on creatinine clearance per the manufacturer guidelines.
15965488|NCT03146728|Other|exercise|energy expenditure will be measured for each of the participants during different conditions, rest, during exercise with the arm crank height high or low. Energy expenditure will also be measured during exercise using different modes (arm ergometer, wheelchair and arm-bike). Results will be compared between rest and exercise and between individuals with SCI and able-bodied.
15965489|NCT03146715|Other|Feeding trial|Children were asked to eat the designated portion of the assigned food once a day for six weeks.
15965490|NCT03146702|Other|Quality of Life|Patients self administor quality of life questionnaires such as Minnesota Living with Heart Failure Questionnaire and EmPHasis-10 questionnaire
15965491|NCT03146689|Drug|Topical NSAID|Applied four times daily
15965492|NCT03146689|Drug|Topical Capsaicin|Applied four times daily
15965493|NCT03146663|Drug|NUC-1031 500 mg|NUC-1031 500 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
15965494|NCT03146663|Drug|NUC-1031 750mg|NUC-1031 750 mg/m2 on Days 1, 8, and 15 of a 28-day cycle
15965495|NCT03146650|Biological|Ipilimumab|Given IV
15965496|NCT03146650|Other|Laboratory Biomarker Analysis|Correlative studies
15965497|NCT03146650|Biological|Nivolumab|Given IV
15965498|NCT03146637|Biological|Activated CIK|Activated CIK armed with bispecific antibody were infused for 3 days，after 2 days，bispecific antibody was infused separately for 3 days
15965499|NCT03146637|Biological|CIK|Traditional CIK were infused for 3 days
15965500|NCT03146624|Other|attachment retained obturator|obturator which retained by attachment
15965501|NCT03146624|Other|clasp retained obturator|obturator which retained by clasp
15965502|NCT03146611|Diagnostic Test|nCD64|neutrophil CD64
15965503|NCT03146611|Diagnostic Test|Neutrophil/Lymphocyte Ratio|Neutrophil/ lymphocyte ratio
15965504|NCT03146598|Other|No intervention as it is a observational study|No intervention as it is a observational study
15965505|NCT03146585|Device|PBR assessment|Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.
15965506|NCT03146572|Behavioral|Sit Down and Play|Sit Down and Play (SDP) is designed to be a brief, low-cost intervention that incorporates key theoretical constructs to elicit positive parenting behaviors. It is intended to be delivered by existing clinical staff, nonprofessionals, or volunteers during each of the eight well-child visits between 2-24 months of age while a family waits to be seen by their pediatrician in the examination room
15965507|NCT03146572|Other|Handout|Handout providing written descriptions of strategies to encourage positive parenting behaviors
15965508|NCT03146559|Device|EMG and TENS|Healthy hand EMG signal measured while making voluntarily wrist dorsi flexion will activate TENS, which will be placed on the paretic forearm and will produce wrist dorsi flexion.
15965509|NCT03146559|Device|TENS only|Automatic TENS stimuli to the paretic dorsi flexors (i.e., producing wrist dorsi flexion).
15965510|NCT03146533|Drug|Fludarabine|Fludarabine 30 mg/m2/day IV for 3 days.
15965511|NCT03146533|Drug|Cyclophosphamide|patients will receive a standard pre-conditioning regime with cyclophosphamide 0.8g/m2/day IV for 2 days.
15965512|NCT03146533|Biological|CD19 CART|CD19 CART cells will be administered using a split dose on day0(10%), 1(30%), and 2(60%) after completion of the chemotherapy.
15965513|NCT03146520|Device|EarlyTect Colon Cancer|SDC2 methylation assay by qPCR using EarlyTect Colon Cancer kit
15965514|NCT03146481|Drug|Aceclofenac|Aceclofenac 100 mg tablet given one hour before starting the root canal treatment
15965515|NCT03146481|Other|Placebo|Placebo tablet given one hour before starting the root canal treatment
15965516|NCT03146468|Drug|Nivolumab Injection|Human monoclonal antibody targeting programmed death-1 (PD-1) cell surface receptor
15965517|NCT03146455|Other|no intervention|no intervention
15965518|NCT03146442|Behavioral|Breakfast|For 6 months, the participants will either skip breakfast or will habitually consume a NP or HP breakfast every day.
15965519|NCT03146429|Diagnostic Test|I-123 FP-CIT Single photon emission tomography|Brain scan for dopamine transporter
15965522|NCT03146403|Biological|GEN-003|HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP4 and glycoprotein D
15965523|NCT03146403|Biological|Matrix-M2|Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
15965524|NCT03146403|Other|0.9% normal saline|Placebo
15965525|NCT03146390|Drug|Essential oils|all subjects will perform all interventions of all arms
15965526|NCT03146390|Drug|Alcohol free essential oils|all subjects will perform all interventions of all arms
15965527|NCT03146390|Other|Water|all subjects will perform all interventions of all arms
15965528|NCT03146377|Drug|Capecitabine|1250 mg/m2 BD orally for 1 week of a 2-week cycle (i.e. 1 week on, 1 week off)
15965529|NCT03146377|Drug|Oxaliplatin|85 mg/m2 IV on day 1 of a 2-week cycle
15965530|NCT03146377|Drug|Irinotecan|165 mg/m2 IV on day 1 of a 2-week cycle
15965531|NCT03146364|Device|Virtual Reality - Virtual Interactive Supermarket|"SeeMe is a PC based, innovative, comprehensive, clinician-controlled exercise and diagnostic system. SeeMe is designed to aid the rehabilitation process, and track patients' progress.
~Virtual Interactive Supermarket- one of the SeeMe Tasks, the user need to buy products by according to specific instruction"
15965532|NCT03146351|Other|Family based early intervention program (NDT-Bobath based)|Family based early intervention program is NDT - Bobath based home program. Physiotherapist teaches principles of the treatment to infants' family. Family applies the program at home.
15965533|NCT03146338|Other|Magnesium-rich mineral water (Rozana)|intakes of 1.5 L by day
15965534|NCT03146325|Drug|BISMUTH TETRACYCLINE METRONIDAZOLE OMEPRAZOLE|A 14-day quadruple Hp eradication therapy consisting of: omeprazole (20 mg twice daily) plus 3 capsules q.i.d., each containing 420 mg of bismuth subcitrate potassium, 375 mg of metronidazole and 375 mg of tetracycline hydrochloride, for 14 days
15965535|NCT03146325|Drug|MATCHING PLACEBO|TO BE PREPARED BY LICENSED COMPOUNDING PHARMACY
15965536|NCT03146312|Dietary Supplement|MVM/phytochemical supplement|Consumption of an MVM/phytochemical supplement for 4 weeks
15965537|NCT03146312|Dietary Supplement|Placebo|Consumption of a placebo tablet identical in size, shape and color to the treatment tablet
15965538|NCT03146299|Procedure|TLH vs LAVH|"TLH: The subjects undergoing laparoscopic hysterectomy with a giant uterus of 500 g or more
~LAVH: The subjects undergoing Laparoscopic Assisted Vaginal Hysterectomy with a giant uterus of 500 g or more"
15965539|NCT03146286|Dietary Supplement|Saturated fat|Palm stearin
15965540|NCT03146286|Dietary Supplement|Placebo|Water
15965541|NCT03146286|Dietary Supplement|Fish Oil|Fish Oil, Omega 3 PUFA
15965542|NCT03146273|Dietary Supplement|Multivitamins|"After the study product administration blood tests will be performed in order to calculate the AUC for each mineral and vitamin - Vit A Vit E Folic Acid Vit C Calcium Magnesium
~After the washout period, the same procedure will be done for the additional formulation of the multivitamins."
15965543|NCT03146260|Procedure|Conventional TESE|usual procedure for sperm extraction
15965544|NCT03146260|Procedure|Microdissection TESE|Procedure of extraction is performed under the operating microscope
15965545|NCT03146247|Drug|Apremilast;Apremilast;Apremilast 10 MG; 20 MG; 30 MG Oral Tablet|All patients are scheduled to receive Apremilast with a titration phase of one week, followed by 23 weeks of regular treatment.
15965546|NCT03146234|Genetic|CAR-GPC3 T cells|"Self-controlled dose escalation will be applied to the first 3 - 6 subjects enrolled.
~Classical 3+3 dose escalation will be applied to subsequent subjects based on the self-controlled dose escalation study."
15965547|NCT03146221|Other|To look for serum microRNA profiles associated with restenosis|To look for serum microRNA profiles associated with restenosis
15965548|NCT03146195|Other|Dynamic Magnetic resonance imaging|
15965549|NCT03146182|Behavioral|CRP-algorithm|a strategy based on CRP guided antibiotic stewardship
15965550|NCT03146182|Behavioral|PCT-algorithm|a strategy based on PCT guided antibiotic stewardship
15965551|NCT03146169|Behavioral|Training group|"The training workshop includes four two-hour sessions:
~Session one - a knowledge, self-efficacy, and motivation enhancement session at baseline; Session two - an interpersonal communication and leadership skills session at one week; Session three - a motivation enhancement session at one month Session four - an experience sharing session at three months"
15965552|NCT03146156|Behavioral|Lifestyle Intervention|The lifestyle intervention is healthy eating (Medeterranian diet) and exercise to decrease weight by 5-7% compared to prepregnancy weight.
15965553|NCT03146143|Procedure|ultrafiltration|ultrafiltration after cardiopulmonary bypass
15965554|NCT03146130|Biological|Variation of behaviors of Parkinson's disease|Variation of hyper dopaminergic behaviors of Parkinson's disease
15965555|NCT03146104|Drug|Propofol|Intraoperative anesthesia will be maintained using propofol 100-150 mcg/kg/min, oxygen and air and FiO2 of 40% in propofol group (GROUP P)
15965556|NCT03146104|Drug|Isoflurane|in(GROUP I) maintenance will be done with 1 MAC of isoflurane, oxygen and air and FiO2 of 40%.
15965557|NCT03146091|Other|Nonantibiotic treatment of uncomplicated diverticulitis|Patients randomized to this arm will be treated without antibiotics in the outpatient setting. Pain will be managed with appropriate analgesia as per protocol.
15965558|NCT03146091|Other|Antibiotic treatment of uncomplicated diverticulitis|Patients randomized to this arm will be treated with antibiotics in the outpatient setting. Pain will be managed with appropriate analgesia as per protocol.
15965559|NCT03146065|Biological|PF-06730512|Comparison of different dosages of PF-06730512 to Placebo
15965560|NCT03146065|Drug|Placebo|Comparison of Placebo to different doses of PF-06730512
15965561|NCT03146052|Drug|PEG-4000 added with citrates and simethicone (PEG-CS) plus Bisacodyl|PEG-4000 added with citrates and simethicone (PEG-CS) (Kit contains 4 pouches, each containing 64.5gr of PEG) and bisacodyl 5 mg tablets
15965562|NCT03146039|Radiation|Radiation Therapy|"Whole pelvis radiation therapy will be delivered according to institutional standard of care.
~SBRT is delivered with 5 fractions of 5.5-8 Gy prescribed to the high-risk CTV, with dose constraints identical to those for high dose rate, volume-directed brachytherapy. The patient will undergo arc therapy with a minimum of two arcs. On-line kV CBCT will be used to verify the isocenter prior to each arc delivery. Patients will be resimulated for SBRT boost planning."
15966142|NCT03141359|Radiation|IMRT|mediastinal radiation
15966143|NCT03141359|Drug|Durvalumab|adjuvant immunotherapy
15965563|NCT03146026|Behavioral|Combined Exercise Training|The CET program was performed for 60 minutes with 5 minutes of warm-up and cool-down per day, 3 times a week for 12 weeks. Combined exercise consisted of 20 minutes of various resistant band exercises (Upper body: seated rows, biceps curl, shoulder flexion, elbow flexion, chest press; Lower body: hip flexion, hip extension, calf raise, leg press, squat) and 30 minutes of treadmill walking. The warm-up and cool down consisted of static stretching. Intensity of exercise was gradually increased from 40-50% heart rate reserve (HRR) in weeks 1-4, and to 60-70% HRR in weeks 9-12. Each training session was fully supervised by the researchers. Every subject wore a heart rate monitor during the whole training session so as to maintain the correct training intensity.
15965564|NCT03146013|Diagnostic Test|MP Diagnostics HTLV Blot 2.4|HTLV I/II Confirmation and Differentiation
15965565|NCT03146000|Drug|lidocaine-prilocaine cream|topical cream
15965566|NCT03146000|Drug|meloxicam rectal suppository|suppository
15965567|NCT03145987|Dietary Supplement|Vitis vinifera extract|
15965568|NCT03145987|Other|Placebo|
15965569|NCT03145974|Device|mechanical ventilation|ventilatory support
15965570|NCT03145961|Drug|Pembrolizumab|200mg intravenous infusion
15965571|NCT03145948|Drug|ABBV-553|It is administered orally.
15965572|NCT03145948|Drug|Placebo|It is administered orally.
15965573|NCT03145935|Diagnostic Test|Abdominal compression (AC)|An echocardiography with stroke volume measurement coupled with an abdominal compression will be performed before and after ta diuretics induced diuresis of 10ml/kg in pediatric patients hospitalized in a pediatric intensive care unit (PICU) diagnosed with fluid overload
15965574|NCT03145935|Diagnostic Test|blood sample|proteinemia and hematocrit will be measured before and after a diuretics induced diuresis of 10ml/kg
15965575|NCT03145922|Other|Observational Study|Observational study utilizing bronchoscopy, and imaging
15965576|NCT03145909|Drug|ABBV-176|Intravenous infusion
15965577|NCT03145896|Dietary Supplement|vitamin D|After the gastroscopy all patients will be taught to take 4000 unit of vitamin D (25(OH)D) daily (not a specific brand) , for the next 2 week. All patients will be invited for follow-up in 2 weeks to get the histopathology result. In this encounter we will take again blood sample for 25(OH)D, calcium, phosphate, CRP and complete blood count including hemoglobin. a control group will not take the Vitamin D supplements.
15965578|NCT03145883|Other|Home-Based Aerobic Exercise|
15965579|NCT03145870|Other|Echoing of the lower limbs and measuring the systolic pressure index|Echoing of the lower limbs and measuring the systolic pressure index
15965580|NCT03145857|Drug|[68]Ga-HA-DOTATATE|All participants will be injected with [68]Ga-HA-DOTATATE approximately 60 minutes before PET/CT or PET/MRI scan.
15965581|NCT03145831|Drug|Somavaratan|All subjects will receive somavaratan 3.5 mg/kg twice monthly (every 15 days ± 2 days). Administered as a subcutaneous bolus injection.
15965582|NCT03145818|Other|VD-HCBS|Like the participant-directed programs developed for Medicaid programs,VD-HCBS maximizes Veteran-centered care and independence. VD-HCBS provides Veterans with a monthly financial allotment based on an assessment of the extent of their need for assistance with personal care due to injury or the impact of disease
15965583|NCT03145792|Behavioral|Seeking Safety|Seeking Safety (SS) is a present-focused, evidence-based cognitive-behavioral therapy for trauma and/or addiction. It offers safe coping skills and education relevant to both problem areas.
15965584|NCT03145792|Behavioral|CBT for Pathological Gambling|Cognitive Behavior Therapy for Pathological Gambling (CBT-PG) is an evidence-based therapy for gambling problems. It focuses on cognitive correction, problem solving, social skills and relapse prevention.
15965585|NCT03145766|Biological|VRVg 2|Modified formulation 1 (Low) of Purified Vero Rabies Vaccine Serum Free
15965586|NCT03145766|Biological|VRVg 1|Initial formulation of Purified Vero Rabies Vaccine Serum Free
15965587|NCT03145766|Biological|Imovax Rabies|Purified inactivated rabies vaccine prepared on human diploid cell cultures
15965588|NCT03145766|Biological|VRVg 2|Modified formulation 2 (Medium) of Purified Vero Rabies Vaccine Serum Free
15965589|NCT03145766|Biological|VRVg 2|Modified formulation 3 (High) of Purified Vero Rabies Vaccine Serum Free
15965590|NCT03145766|Biological|Human Rabies Immunoglobulins (HRIG)|Commercialized formulation of HRIG
15965591|NCT03145753|Other|HIV/HCV Education plus Testing|Education included a half day educational program and the provision of supporting materials to enhance HIV testing, such as a clinical decision algorithm to perform HIV test and clinical remainders to help meet with the current Spanish Early Diagnosis HIV Testing Recommendations. Half day educational program, to promote early diagnosis of HIV, HCV, in a Primary Care Health Area.To Improve knowledge and current trends in the prevention, diagnosis and management of HIV infection among non health professionals specialists in infectious diseases.DRIVE 03 program will offer rapid HIV tests, and testing staff to conduct all study procedures.The study activities will be carried out by the trained testing staff.
15965592|NCT03145753|Other|HIV/HCV Education|Only education and support will be provided in this arm
15965593|NCT03145740|Other|Intensive F.O.T.T.®|Therapeutic F.O.T.T.® intervention provided by Occupational Therapists (OTs). The intervention consists of positioning the patient, and giving sensory input to the hands and face in order to stimulate and facilitate swallowing of saliva or small amounts of food and drink, if considered safe.
15965594|NCT03145740|Other|Unspecific Stimulation of face and mouth|The intervention consists of positioning the patient and either washing his face, the hands, or brushing teeth, apply lipbalm, with no specific stimulation or facilitation of swallowing
15965595|NCT03145727|Device|Placebo Group|In this group, the TENS will be administered by 30 minutes prior to chemotherapy administration with the stander electrodes positions, in the opposite arm of the chemotherapy infusion, but in this group the electrical stimulation will be performed just by 10 seconds and turn off for all reminiscent time of the protocol.
15965596|NCT03145727|Device|Low Frequency Group|In this group the TENS will be administered by 30 minutes prior to chemotherapy administration with the stander electrodes positions, in the arm opposite the chemotherapy infusion. The electrical stimulation will be continued for all time secession. The electrical pulse parameters will be setting according describe early.
15965631|NCT03145467|Drug|Paracetamol|1000 mg of paracetamol (Parol Tablet - Atabay İlaç Fabrikası A.Ş.) Oral (PO) was given 100 patients
15965632|NCT03145467|Drug|Zolmitriptan|Zolmitirptan 2,5 mg (Zomig Tablet - Astra Zeneca) oral (PO) was given 100 patients
15965597|NCT03145727|Device|High Frequency Group|In this group the TENS will be administered by 30 minutes prior to chemotherapy administration with the stander electrodes positions, in the arm opposite the chemotherapy infusion. The electrical stimulation will be continued for all time secession. The electrical pulse parameters will be setting according describe early.
15965598|NCT03145714|Drug|Maintainance of anesthesia with Intravenous Propofol infusion|The dosage of Intravenous Propofol will be titrated to maintain BIS Values between 40 -60.
15965599|NCT03145714|Drug|Maintainance of anesthesia with Intravenous Dexmedetomidine|The dosage of Intravenous Dexmedetomidine will be titrated to maintain BIS Values between 40 -60.
15965600|NCT03145688|Behavioral|Family Physical Activity Planning|"Families will receive the same guidelines as the standard education control group but will also be provided with family physical activity planning material. This material will include a skill training content workbook on how to plan for family physical activity. The material includes a brainstorming exercise for parents where they list physical activities they think their children have found fun in the past, as well as activities that they would find enjoyable to do as a family. We will provide this material as prompts/suggestions. Families will be instructed to plan for when, where, how, and what physical activity will be performed & then track their physical activity. These aspects will be re-introduced and discussed at week 6 and week 12 in booster sessions"
15965601|NCT03145688|Behavioral|Family Physical Activity Habit Formation|Families will receive the same content as the education control condition and the physical activity planning condition but with additional material on creating physical activity support habits. A key component of the habit section will be based on planning for context-dependent repetition, with pointers on how to maintain repetition as habit forms. The importance of creating cues for parental support of child physical activity is then outlined. Cues will also be considered factors that a) can precede the support activity but b) not be present very often when the activity is not to be performed. We will suggest that cues that have repeated exposure during times when family physical activity is not present Parents will then be asked to brainstorm and create a plan of consistency and cues with the workbooks provided. These aspects will be re-introduced and discussed at week 6 and week 12 in booster sessions.
15965602|NCT03145675|Drug|Enoxaparin (Staged-dose PCI Group)|Enoxaparin 0.5+0.25 mg/kg administered intravenously.
15965603|NCT03145675|Drug|Enoxaparin (Single-dose PCI Group)|Enoxaparin 0.75 mg/kg administered intravenously.
15965604|NCT03145675|Drug|Enoxaparin (High-dose Group)|Enoxaparin 0.75 mg/kg administered intravenously.
15965605|NCT03145675|Drug|Enoxaparin (Standard-dose Group)|Enoxaparin 0.5 mg/kg administered intravenously.
15965606|NCT03145662|Device|high pressure balloon|high pressure balloon will be used to treat stenosis
15965607|NCT03145662|Device|cutting balloon|cutting balloon will be used to treat stenosis
15965608|NCT03145649|Other|Dietary therapy or insulin injection|
15965609|NCT03145636|Device|vBloc Maestro Rechargeable System|Intra-abdominal vagal blocking neuromodulation device for the treatment of obesity
15965610|NCT03145636|Other|vBloc Achieve Weight Management Program|Remotely accessible web-based program to add additional support to subjects with vBloc therapy
15965611|NCT03145636|Other|Control Weight Management (CWM) program|In person visits with Registered Dietician, or trained staff who will counsel subjects on energy balance, dietary intake, physical activity and eating behavior modification.
15965612|NCT03145623|Drug|Elbasvir and Grazoprevir|Elbasvir 50 mg and grazoprevir 100 mg during the French temporary authorization for use (ATU) program
15965613|NCT03145610|Other|Placebo toothpaste|During an experimental 3-week period of undisturbed mechanical plaque accumulation in the implants, implants randomly assigned to Placebo group will be submitted to a chemical plaque control (three times per day) using a Triclosan toothpaste.
15965614|NCT03145610|Other|triclosan/copolymer/fluoride toothpaste|During an experimental 3-week period of undisturbed mechanical plaque accumulation in the implants, implants randomly assigned to triclosan/copolymer/fluoride group will be submitted to a chemical plaque control (three times per day) using a triclosan/copolymer/fluoride toothpaste.
15965615|NCT03145597|Device|Laminate veneer of composite|Composite laminate veneers, 2-4-6 veneers per patient
15965616|NCT03145597|Device|Laminate veneer of ceramic|laminate of ceramic (Empress Esthetic, Ivoclar Vivadent), ceramic laminate veneer, 2-4-6 veneers per patient will be made.
15965617|NCT03145584|Drug|Continuous Bupivacaine via Adductor Canal Saphenous Catheter|12.5 mg/hr of bupivacaine was administered continuously via a paraneural catheter for 48 hours following surgery to determine whether superior analgesia was obtained when compared to single shot block with a sham catheter.
15965618|NCT03145584|Other|Single Shot Adductor Canal Saphenous Block with Bupivacaine|A sham catheter was placed on the skin and covered in a dressing to blind the patient, data collector and investigator as to group allocation
15965619|NCT03145571|Procedure|Continuity of midwifery care|Pre-natal care in rural villages performed by the midwives from the local hospital
15965620|NCT03145558|Drug|Tirapazamine|Replacing the standard chemotherapy agent doxorubicin used in TACE with tirapazamine
15965621|NCT03145558|Drug|Doxorubicin|Standard of care for TACE
15965622|NCT03145545|Device|Apha/beta T and CD19+ cell depletion using CliniMACS device|Stem cells will be processed using the CliniMACS device for alpha/beta and CD19+ T cell depletion. Processing of cells using the CliniMACS will occur in accordance with the Investigator Brochure and Technical Manual following the laboratory standard operating procedures (SOPs) and using aseptic technique.
15965623|NCT03145532|Other|tDCS plus robotic training|Children will first receive 20 min of tDCS (real or sham, see Arms), then will receive 1 hr of upper limb robotic therapy in which the child will use their impaired arm and hand to move a joystick controlling a cursor to a set of targets on a video screen in front of the child.
15965624|NCT03145519|Device|Vasofix Certo Catheter|Placement of IV-catheter
15965625|NCT03145519|Device|OptiVein Catheter|Placement of IV-catheter
15965626|NCT03145506|Device|Multimodal Spectroscopy|optical measurement of excised tissue
15965627|NCT03145493|Device|drainage|Administration of IV tranexamic acid at the moment of anesthetic induction (1g) and at tourniquet release (1g), installing a suction drain
15965628|NCT03145480|Drug|Obinutuzumab|100 mg on day 1 and 900 mg on day 2 Cycle 1, 1000 mg on day 8 and 15 of Cycle 1, and 1000 mg on day 1 of Cycles 2-6
15965629|NCT03145480|Drug|Ibrutinib|560mg po daily
15965630|NCT03145480|Other|CHOP|cyclophosphamide, doxorubicin, vincristine, and prednisone
15965633|NCT03145454|Device|electroencephalography helmet|electroencephalography helmet with twelve electrodes will be performed during surgical gesture to determine the pain of child.
15965634|NCT03145454|Device|dermal electrode|dermal electrode on the back of the hand will be performed during surgical gesture to determine the pain of child.
15965635|NCT03145454|Device|blood pressure sensors|blood pressure sensors on the finger will be performed during surgical gesture to determine the pain of child.
15965636|NCT03145454|Device|Pupillometry glasses|Pupillometry glasses will be performed during surgical gesture to determine the pain of child.
15965637|NCT03145454|Device|Holter|Three electrodes electrocardiography on the chest will be performed during surgical gesture to determine the heart rate variability.
15965638|NCT03145441|Device|CytoSorb®|CytoSorb® is a biocompatible, high adsorptive polymer indicated in conditions where cytokine levels are extremely elevated.
15965639|NCT03145428|Diagnostic Test|CBC-Diff Monocyte volume width distribution (MDW)|MDW measurement used to detect sepsis. Results will not be used to manage patients
15965640|NCT03145415|Procedure|Caudal block|1 cc per kg of 0.2% ropivicaine in the caudal space given before the start of surgery.
15965641|NCT03145415|Procedure|Bilateral Pudendal block|0.5 cc per kg of 0.2% ropivicaine. Half of the volume given as a right pudendal block and the remaining volume given on the left pudendal nerve block given prior to the start of surgery
15965642|NCT03145402|Biological|Intracoronary injection of stem cell|Autologous bone marrow-derived mononuclear cells are obtained from 100-150ml of bone marrow aspirated under local anaesthesia from the iliac crest. Intracoronary infusion of the cells is performed in patients with Heart failure via conventional percutaneous intracoronary intervention techniques.
15965643|NCT03145402|Biological|Placebo|Injection of Placebo in patients with Heart failure via coronary arteries
15965644|NCT03145389|Procedure|Epidural catheter placement|After explaining about the procedure an 18 Gauge epidural catheter was inserted into thoracic 11-12 inter vertebral space under strict asepsis. Before inserting the epidural needle same space was infiltrated with adequate amount of 2% Lignocaine with Adrenaline (1: 200,000) to make the procedure pain free. Epidural space was confirmed by loss of resistance technique.
15965645|NCT03145376|Diagnostic Test|geriatric assessment|"Clinical evaluation and geriatric assessment with:
~CIRS: CIRS (Cumulative Illness Rating Scale)
~ADL (Activities of Daily Living);
~IADL (InstrumentalActivities of Daily Living);
~Mini Nutritional Assessment;
~Evaluation of quality of life (Short Form 36, SF-36).
~Making a traditional 12-lead ECG.
~A single lead electrocardiographic registration (DI, D II and D III) of 5 minutes baseline and 5 minutes with controlled breathing (15 breaths / min), using the Spectralink 2011 program, which allows us to identify and calculate the variables object of study;
~transthoracic echocardiogram."
15965646|NCT03145363|Behavioral|Intervention|The intervention group will receive 2-5 interactive text message sequences per week. These messages will invite students to reply using keywords and short free text replies. Messages come from a library of strength-based peer quotations (reviewed for safety), psychoeducational interactions, and games designed to promote emotional skills and use of resources.
15965647|NCT03145363|Behavioral|Control|"The control group will receive 1-2 (non-interactive) text messages per week containing general SoS concepts (e.g., Remember: more strengths are better when times get tough)."
15965648|NCT03145350|Other|High-fat, low-carbohydrate|Dietary intervention: 4 week
15965649|NCT03145350|Other|Low-fat, high-carbohydrate|Dietary intervention: 4 week
15965650|NCT03145337|Biological|FlexHD ADM (Cohort A)|Tissue assisted breast reconstruction with FlexHD pliable perforated ADM
15965651|NCT03145337|Biological|AlloDerm RTU ADM (Cohort B)|Tissue assisted breast reconstruction with AlloDerm RTU perforated ADM
15965652|NCT03145324|Other|Collection of vaccine histories|
15965653|NCT03145311|Procedure|Repetitive transcranial magnetic stimulation (rTMS)|
15965654|NCT03145298|Biological|Allogeneic Human Cardiosphere-Derived Stem Cells|Human Allogeneic Cardiosphere-Derived Cells is a biologic product consisting largely of cells grown from donated human heart muscle tissue
15965655|NCT03145298|Biological|Placebo|For use in Phase 1b - Double-blind randomized control portion of the study
15965656|NCT03145285|Drug|Abiraterone Acetate|"Cohort 1:
~Patients locally advanced/metastatic ACC patients with uncontrolled Cushing's syndrome despite Mitotane +/- chemotherapy will be treated with single agent AA.Mitotane and chemotherapy will be interrupted and AA will be continued till progression and/or until progression of Cushing's syndrome.
~Cohort 2:
~Mitotane-naïve patients with newly diagnosis of ACC associated with Cushing's syndrome not amenable to surgical resection will be treated with AA for 4 weeks followed by AA + Mitotane +/- first-line chemotherapy. AA in association with Mitotane will be administered for 3 months. If the primary endpoint is obtained before 1 month (i.e. 2 or 3 weeks from Abiraterone start), then Mitotane +/- chemotherapy can be started upon the clinician's decision."
15965657|NCT03145272|Drug|Oxycodone|A single weight-adjusted oxycodone dose of 0.1 mg/kg is administered as per standard clinical dosing guidelines
15965658|NCT03145259|Drug|Diclofenac Epolamine Patch|patch
15965659|NCT03145259|Drug|diclofenac sodium solution|solution
15965660|NCT03145246|Procedure|regeneration treated teeth loss|number of regeneration treated teeth loss
15965661|NCT03145246|Procedure|regenerated treated teeth with clinical attachment loss|regenerated treated teeth with clinical attachment loss ≥ 2 mm
15965662|NCT03145233|Other|Isometric exercise programme|Exercise programme where the muscle length and joint angle do not change due to the limb being held in a static position
15965663|NCT03145233|Other|Isotonic exercise programme|Exercise programme where both the muscle length and joint angle do change, consisting of concentric muscle actions (where the muscle shortens) and eccentric muscle actions (where the muscle lengthens)
15965664|NCT03145220|Drug|EA-230|Active intervention
15965665|NCT03145220|Other|Placebo (NaCl)|Placebo intervention
15965666|NCT03145207|Drug|Lidocaine patch|lidocaine patch
15965667|NCT03145194|Drug|Ticagrelor|2 x 90mg Ticagrelor tablets
15965668|NCT03145194|Other|Placebo|2 x matching placebo tablets
15965669|NCT03145181|Drug|Teclistamab (IV)|Participants will receive IV infusion of Teclistamab.
15965670|NCT03145181|Drug|Teclistamab(SC)|Participants will receive SC injection of Teclistamab.
15965671|NCT03145168|Other|High Target Mean Arterial Pressure|High target group (80-85 mm of Hg).
15965673|NCT03145155|Behavioral|Integrating services for noncommunicable diseases in continuum of care for mothers and children|The intervention package will comprise of two components, (1) utilization of CoC card and (2) health education on CoC in maternal, newborn and child health (MNCH), NCD and nutrition. The CoC card will be distributed to mothers by midwives at the time of receiving ANC. The CoC card includes CoC services from first antenatal care(ANC) to last postnatal care(PNC) including four ANC, skilled birth attendance (SBA) and four PNC and essential services. Pregnant women will get stickers if they receive above services. Health education will be given by Public Health Supervisors 2 at the health facilities. Health education will be given three times during pregnancy and one time during postpartum period with pamphlets and posters.
15965674|NCT03145155|Behavioral|Ordinary health education for pregnant women|The ordinary health education intervention will cover schedule for ANC, delivery and PNC; danger signs; birth preparedness and nutrition. Health education will be given three times during pregnancy and one time during postpartum period with pamphlets and posters.
15965675|NCT03145142|Procedure|Umbilical cord milking|At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before it is clamped. The procedure infuses a placental transfusion of blood into the preterm infant and can be done in 15-20 seconds
15965676|NCT03145142|Procedure|Delayed Cord Clamping|At delivery, delayed cord clamping will be performed by having the delivering obstetrician delay clamping of the umbilical cord for at least 60 seconds.
15965677|NCT03145129|Device|Continuous Positive Airway Pressure|Continuous Positive Airway Pressure
15965678|NCT03145116|Device|CT ASPHINA 509|Intraocular lens
15965679|NCT03145103|Device|CT ASPHINA 409|intraocular lens
15965680|NCT03145077|Procedure|Dynamic Contrast-Enhanced Magnetic Resonance Imaging|Undergo DCE-MRI
15965681|NCT03145077|Other|Questionnaire Administration|Ancillary studies
15965682|NCT03145064|Drug|Zanubrutinib|Administered at a dose of 160 mg orally
15965683|NCT03145051|Other|Saline solution|a nasal irrigation care
15965684|NCT03145051|Other|Respimer Netiflow|a nasal irrigation care
15965685|NCT03145038|Drug|Vericiguat(BAY1021189, high-dose pediatric-formulation)_fed|Vericiguat high-dose pediatric formulation (fed; American breakfast), 10 mg given as 20 x 0.5 mg mini tablets
15965686|NCT03145038|Drug|Vericiguat(BAY1021189, high-dose pediatric-formulation)_fasted|Vericiguat high-dose pediatric formulation (fasted),10 mg given as 20 x 0.5 mg mini tablets
15965687|NCT03145038|Drug|Vericiguat(BAY1021189, low-dose pediatric-formulation)_fed|Vericiguat low-dose pediatric-formulation (fed; American breakfast), 2.5 mg given as 25 x 0.1 mg mini tablets
15965688|NCT03145038|Drug|Vericiguat(BAY1021189,10 mg IR film-coated tablets,intact)_fed;American breakfast|10 mg IR tablet, intact (fed; American breakfast)
15965689|NCT03145038|Drug|Vericiguat(BAY1021189,10 mg IR film-coated tablets,crushed)_fed;American breakfast|10 mg IR tablet, crushed (fed; American breakfast)
15965690|NCT03145038|Drug|Vericiguat(BAY1021189,10 mg IR film-coated tablets,intact)_fed;Continental breakfast|10 mg IR tablet, intact (fed; Continental breakfast)
15965691|NCT03145025|Device|Retisert|Intravitreal Implant
15965692|NCT03145025|Drug|Fluocinolone Acetonide Intravitreal Implant|Intravitreal Implant
15965693|NCT03145012|Drug|Ranitidine|Thirty subjects will receive Ranitidine to a maximum of 900 mg/day in 2 daily oral doses for 6 weeks. The dosage target is 8 mg/kg/day, but the range of ranitidine intake will be between 7.5- 9 mg/kg/day. This is due to the formulation of the tablets, sold as 75, 150, and 300mg tablets.
15965694|NCT03144999|Biological|AAVCAGsCD59|AAVCAGsCD59 is administered as a single intravitreal injection in an office setting
15965695|NCT03144986|Device|Deep Insula-coil rTMS|Before administering TMS participants will undergo cue stimuli provocation, consisting of 32 professional color images of high calorie, sweet and savory food. This will follow with TMS. All subjects will receive prefrontal deep TMS (18 Hz, 2 sec on, 20 sec off, over approximately 30 min) 5 times per week, for 6 weeks, for a total of 30 sessions as a part of an active treatment phase. Maintenance treatment phase will include two sessions of rTMS (18 Hz, 2 sec on, 20 sec off, over approximately half an hour) weekly for the period of 6 weeks.
15965696|NCT03144973|Diagnostic Test|periosafe|mouth rinsing quick-test
15965697|NCT03144960|Procedure|Mechanical Thrombectomy|mechanical thrombectomy with retrievable stents, thrombus aspiration, retraction, wire disruption
15965698|NCT03144947|Biological|Trastuzumab IV|"Pre-randomization phase:
~FEC (fluorouracil 500 mg/m2; epirubicin 75 mg/m2; cyclophosphamide 500 mg/m2) x 3 cycles
~Post-randomization phase:
~Group A: Trastuzumab IV (8 mg/kg loading dose, followed by 6 mg/kg) plus pertuzumab IV (840 mg loading dose, followed by 420 mg) plus docetaxel (75 mg/m2)*, every 3 weeks for 4 cycles.
~by 420 mg) plus docetaxel (75 mg/m2)*, every 3 weeks for 4 cycles.
~*The dose of docetaxel may be escalated to 100 mg/m 2 at the investigator's discretion on subsequent cycles if the initial dose is well tolerated. After surgery, study patients will receive trastuzumab x 14 cycles using the same formulation (SC or IV) of the preoperative phase."
15965699|NCT03144947|Biological|Trastuzumab SC|"Pre-randomization phase:
~FEC (fluorouracil 500 mg/m2; epirubicin 75 mg/m2;
~Group B: Trastuzumab SC (fixed dose of 600 mg) plus pertuzumab IV (840 mg loading dose, followed by 420 mg) plus docetaxel (75 mg/m2)*, every 3 weeks for 4 cycles.
~*The dose of docetaxel may be escalated to 100 mg/m 2 at the investigator's discretion on subsequent cycles if the initial dose is well tolerated. After surgery, study patients will receive trastuzumab x 14 cycles using the same formulation (SC or IV) of the preoperative phase."
15965700|NCT03144947|Biological|Pertuzumab|pertuzumab IV (840 mg loading dose, followed by 420 mg) weeks for 4 cycles (both arms)
15965701|NCT03144947|Drug|Docetaxel|docetaxel (75 mg/m2), every 3 weeks for 4 cycles (both arms). The dose of docetaxel may be escalated to 100 mg/m2 at the investigator's discretion on subsequent cycles if the initial dose is well tolerated.
15965702|NCT03144934|Drug|GX-I7|Interleukin-7 (IL-7) is T cell growth factor that can be used for treating lymphopenia patients. GX-I7 is a protein drug recombining human IL-7 and hybrid Fc (hyFc). HyFc made by Genexine is composed of hinge-CH2 region of Immunoglobulin D (IgD) and CH2-CH3 region of Immunoglobulin G4 (IgG4). The recombined region is not exposed and each region's characteristics can reduce immunogenicity and improve the efficacy of drug. Consequently, it will be able to treat the patients with lymphopenia in effective ways.
15965703|NCT03144934|Drug|Placebo|This is the placebo of GX-I7 described above.
15965739|NCT03144557|Other|Education|Education protocol included 4 individual sessions of verbal and graphic instructions to correct inhalation technique in patients with COPD
15965704|NCT03144921|Behavioral|psychoeducational skills training intervention|This protocol is a minimal risk care values clarification /care planning and psychoeducational skills training intervention, delivered as a workshop series plus one in-home session for people in the early stages of memory loss and their care partner together.
15965705|NCT03144908|Other|Standard Operating Procedures|Observational on Standard Operating Procedures
15965706|NCT03144895|Procedure|Laying a radial or femoral arterial catheter|Laying a radial or femoral arterial catheter
15965707|NCT03144882|Drug|Curcumin Pill|Turmeric rhizome at first was washed and dried out in a warm and dry place for a week , then powdered rhizomes were encapsulated by Clinical Pharmacy Research Center of Shahid Beheshti University of Medical Sciences, using hard gelatin capsules. Also placebo capsules were made by the same center using Sorbitol. Curcumin level of turmeric was measured by HPTLC analysis for quantification of variability in content of curcumin
15965708|NCT03144882|Drug|Placebo|placebo
15965709|NCT03144869|Behavioral|physical activity monitor and feedback|Children will wear a Runscribe accelerometer for two weeks (children in Arm 2 will also wear a CGM). Runscribe will measure activity levels. Activity data will be downloaded by a researcher, analysed and graphs of daily activity levels prepared. At the child's next routine clinic appointment, child and parent will have 1:1 session with researcher acting as 'physical activity champion'. Session content will be informed by Phase 1, but will involve educational support around PA (including barriers and facilitators to participation) and individualised feedback on PA level). Individualised feedback will involve review of daily PA graphs - addressing times of high and low activity levels. For participants in Arm 2, there will also be review of daily line graphs showing BG trends. As part of standard clinical care, CGM data gets downloaded at routine clinic appointments and is visible on the patient's clinic notes in daily graph form.
15965710|NCT03144856|Drug|Apatinib|Apatinib 500mg, po, qd, every 4 weeks.
15965711|NCT03144843|Drug|Apatinib|Apatinib 500mg, po, qd, every 4 weeks Paclitaxol: 80mg/m2, d1, d8, d15, every 4 weeks
15965712|NCT03144843|Drug|Placebos|Placebo: 500mg, po, qd, every 4 weeks Paclitaxol: 80mg/m2, d1, d8, d15, every 4 weeks
15965713|NCT03144830|Device|Exoskeleton|This is an open study and so all participants involved with be using the exoskeleton to determine the safety and feasibility of its use during the acute rehabilitation phase.
15965714|NCT03144817|Other|Dialysate Sodium Lowering|Dialysate sodium is lowered until nadir sodium level is reached. Participant dialyzes at this sodium level until end of follow-up.
15965715|NCT03144804|Drug|Lamivudine|This drug may help prevent the growth and spread of the cancer cells to other parts of the body.
15965716|NCT03144778|Biological|Durvalumab|Given IV
15965717|NCT03144778|Biological|Tremelimumab|Given IV
15965718|NCT03144765|Procedure|Transanal Total Mesorectal Excision (taTME)|Study procedures consist in 1-team (sequential) or 2-team (combined) low anterior resection with transanal TME using laparoscopic or robotic abdominal assistance.
15965719|NCT03144739|Other|Training in management of children's mental health problems|"General practitioners will be trained using internationally-developed materials, including the World Health Organization's mental health need/service gap (mhGAP) materials and others, adapted for the trial setting (based on formative work that is part of the project). They will be assisted and monitored as part of the ongoing collaborative care program in which they are participating."
15965720|NCT03144739|Other|Current collaborative care protocol|General practitioners have been trained to recognize children's mental health problems and to refer them to a partner community mental health center. They receive feedback about the referral but are not encouraged to take on care for the child themselves.
15965721|NCT03144726|Device|Negative pressure wound therapy|Negative pressure wound therapy is a commonly utilized tool in the hospital setting and will be applied to amputations in our study to determine the effect on surgical site infections
15965722|NCT03144726|Other|Standard dressing|A standard dressing will be applied to the amputations in this arm of the study
15965723|NCT03144713|Drug|Terlipressin|Terlipressin 1mg intravenous bolus at the onset of paracentesis and the remaining as 1 mg doses intravenous at 8 and 16 h after the first dose. ( total -3mg)
15965724|NCT03144713|Drug|Midodrine|Terlipressin 1mg intravenous bolus at the onset of paracentesis and the remaining as 1 mg doses intravenous at 8 and 16 h after the first dose. ( total -3mg)
15965725|NCT03144713|Drug|Albumin|Albumin-8g/L of tap- one half of dose at beginning of tap and rest half after 6 hours of tapping.
15965726|NCT03144687|Drug|Itacitinib|Itacitinib self-administered orally once daily .
15965727|NCT03144687|Drug|Ruxolitinib|Ruxolitinib self-administered orally at the stable dose of < 20 mg daily established before entering the study.
15965728|NCT03144674|Drug|Parsaclisib|Parsaclisib at the protocol-defined dose.
15965729|NCT03144661|Drug|INCB062079|In Part 1, initial cohort dose of INCB062079 at the protocol-defined starting dose, with subsequent dose escalations based on protocol-specific criteria. The recommended dose(s) from Part 1 will be taken forward into Part 2 cohorts.
15965730|NCT03144648|Other|lifestyle|Observational study
15965731|NCT03144635|Drug|Grazoprevir plus Elbasvir|An oral dose of 100 mg/day of grazoprevir as well as an oral dose of 50 mg/day of elbasvir for 12 weeks.
15965732|NCT03144609|Procedure|low PEEP|The control group consisted of obese patients mechanically ventilated by a standardized volume-controlled breathing mode with low respiratory volume without alveolar recruitment maneuver and using low values of PEEP up to 4 cm H2O.
15965733|NCT03144609|Procedure|ARM|The experimental groups also consisted of obese patients mechanically ventilated by a volume-controlled breathing mode with low respiratory volume 7 ml/kg ideal body mass, but with alveolar recruitment maneuver performed immediately after induction, followed every 30 minutes during the hemodynamic stable condition under operation.
15965734|NCT03144609|Procedure|high PEEP|The experimental groups also consisted of obese patients mechanically ventilated by a volume-controlled breathing mode with low respiratory volume 7 ml/kg ideal body mass, but with higher PEEP, provided that the upper limit of 40 cm H20 was not exceeded.
15965735|NCT03144596|Drug|Alfuzosin Hydrochloride 10 MG|Alfuzosin hydrochloride Tablet
15965736|NCT03144596|Drug|Tamsulosin Hydrochloride 0.4 MG|Tamsulosin Hydrochloride Tablet
15965737|NCT03144583|Biological|Adult differentiated autologous T-cells|After pretreatment, adult differentiated autologous T-cells with a chimeric antigen receptor with anti-CD19 specificity will be transfused.
15965740|NCT03144544|Procedure|Pediatric surgical procedures|Eligible surgical procedures were identified using Canadian Classification of Health Interventions (CCI) therapeutic intervention codes.
15965741|NCT03144531|Behavioral|Sleep Intervention for Kids and Parents (SKIP)|Dyadic approach using self-efficacy theory to set goals, anticipate barriers, problem solve
15965742|NCT03144518|Other|Positive Affect Intervention|See Previous Description
15965743|NCT03144518|Other|Neutral Control Intervention|See Previous Description
15965744|NCT03144518|Biological|Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)|Northern Hemisphere Influenza Vaccine 2017/18 (Delivered as part of Standard Care)
15965745|NCT03144505|Behavioral|MCT combined with RT Group|
15965746|NCT03144505|Behavioral|HIIT combined with RT Group|
15965747|NCT03144492|Biological|Blood volume collected specifically for this study|The subject will be sitting in a chair, and a needle will be inserted into a vein in their arm. Study Team will draw about 45ml or 3 tablespoons of whole blood for research.
15965748|NCT03144479|Procedure|right-sided double lumen tube|Verification of a new technique to assess the correct positioning of a right-sided double-lumen tube for left thoracic surgeries, using a central venous catheter wire guide and a radioscopy
15965749|NCT03144466|Combination Product|Pembrolizumab|antiPD1 monoclonal antibody
15965750|NCT03144453|Drug|Sugammadex Injectable Product|Patients receive sugammadex at the end of the surgery
15965751|NCT03144453|Drug|Neostigmine, Atropine|Patients receive neostigmine+atropine at the end of the surgery
15965752|NCT03144414|Procedure|Laparoscopic hysterectomy|Laparoscopic hysterectomy
15965753|NCT03144401|Drug|Misoprostol|mesotac
15965754|NCT03144401|Other|Placebo|Placebo tablet identical to the misoprostol tablet but without the active ingredient
15965755|NCT03144388|Procedure|Variable Stepping Training|Six weeks (20 sessions) of high intensity stepping training in multiple variable environments
15965756|NCT03144388|Procedure|Variable Non-specific Training|Six weeks (20 sessions) of high intensity stepping training in multiple variable environments
15965757|NCT03144375|Other|Medical optimization and education|Medical treatment and education about the sinusitis disease process prior to surgery as compared to baseline surgical and treatment counseling
15965758|NCT03144375|Procedure|Standard of Care sinus surgery|
15965759|NCT03144362|Procedure|Bilateral Sliding Techniques|Bilateral Sliding Techniques
15965760|NCT03144362|Procedure|Unilateral Sliding Techniques|Unilateral Sliding Techniques
15965761|NCT03144336|Behavioral|Information provision|All study participants will receive weekly messages with HIV prevention information.
15965762|NCT03144336|Behavioral|Weekly quizzes|Those in the intervention group receive a weekly quiz by text message that gains them points increasing their chances of winning a prize if answered correctly
15965763|NCT03144336|Behavioral|Rewards for testing HIV-negative|Those in the intervention group are entered into a prize drawing if they test HIV-negative at least once in a three-month period.
15965764|NCT03144323|Behavioral|Reminders|"Four reminders will be set on the patient's mobile phone's Calendar-type app, saying Don't forget to wear your elastics, at 08:00, 13:00, 17:00 and 22:00."
15965765|NCT03144310|Other|lung ultrasound|lung ultrasound and blood gas
15965766|NCT03144297|Other|Lumbar puncture|diagnostic lumbar puncture
15965767|NCT03144297|Other|BOD POD (air-displacement plethysmography)|Assessment of body fat
15965768|NCT03144284|Other|Knowledge, attitude, and practice survey|A knowledge, attitude, and practice questionnaire is going to be distributed to dental interns.
15965769|NCT03144271|Drug|semaglutide|A single dose of 0.625, 1.25, 2.5, 5, 10, 20, 40 or 80 μg/kg semaglutide will be administered subcutaneously (s.c. under the skin).
15965770|NCT03144271|Drug|Placebo|A single dose of placebo will be administered subcutaneously (s.c. under the skin)
15965771|NCT03144245|Biological|AMV564|AMV564 for administration via continuous intravenous daily infusion or subcutaneous dosing
15965772|NCT03144245|Combination Product|AMV564 in combination with pembrolizumab|AMV564 for administration via continuous intravenous daily infusion or subcutaneous dosing.in combination with pembrolizumab given IV every 21 days
15965773|NCT03144232|Device|Active rTMS|rTMS will be delivered via a MagPro double blinded rTMS Research System (MagVenture, Denmark) with a Cool-B65 Butterfly Coil (a combined active and sham coil). We will use a standard resting motor threshold (rMT) determination to determine the TMS dose (49). Treatment will be delivered at 120% rMT. Each active TMS treatment will consist of a total of 4000 pulses of 10Hz stimulation (5s-on,10s-off). Treatments will be delivered at the EEG coordinate for F3 (which approximates the left DLPFC), and will be found using the Beam-F3 method.
15965774|NCT03144232|Device|Sham rTMS|Sham sessions will be delivered using an electronic sham system consisting of a coil that mimics the appearance and sound of TMS, combined with a TENS device which produces a small electric shock mimicking the feeling of real TMS. This type of sham has been demonstrated to be indistinguishable from real TMS.
15965775|NCT03144219|Diagnostic Test|Transcranial Doppler (TCD) ultrasound monitoring|TCD monitoring comatose patients in ICU looking for signs of impaired cerebral compliance
15965776|NCT03144219|Diagnostic Test|Non invasive intracranial compliance monitoring|A sensor of cardiac beat by beat cranial dilation will be used for monitoring intracranial compliance, in non-invasive fashion.
15965777|NCT03144206|Drug|Hyperbaric oxygen|Patients with soft tissue sarcomas will receive HBOT treatment in the immediate postoperative period
15965778|NCT03144193|Other|Topical anti-aging cosmetic cream|Topical anti-aging cosmetic cream
15965779|NCT03144180|Device|Q-cup|This technology is a different way of collecting umbilical cord blood.
15965780|NCT03144167|Other|Analysis of spectroscopic biomarkers of proliferation for six-month survival|Analysis of spectroscopic biomarkers of proliferation, glial reaction, infiltration and glutaminergic metabolism or glycolytic metabolism for six-month survival
15965781|NCT03144154|Behavioral|Self-hypnosis + Self-care|Our groupal intervention is divided into 8 weekly 2-hour sessions in which one self-hypnosis exercise is proposed to participants. Self-care techniques are also discussed (knowing our own needs, self-respect, assertiveness, coping with ruminations...) and homework assignments are proposed to participants, in order to foster positive change.
15965845|NCT03143543|Other|Group B Parallel Placebo|Oral placebo vs 10 mg lorcaserin
15965782|NCT03144141|Other|Electrical recording of uterine activity by EHG either directly at the emergency or at the hospitalization|Electrical recording of uterine activity by EHG either directly at the emergency or at the hospitalization
15965783|NCT03144128|Dietary Supplement|Vitamin D|5,000IU vitamin D given daily for 12 weeks
15965784|NCT03144128|Dietary Supplement|Placebo|Placebo capsules given daily for 12 weeks
15965785|NCT03144115|Drug|Oxytocin|
15965786|NCT03144115|Drug|Placebos|
15965787|NCT03144102|Behavioral|Virtual Reality-based therapy for upper-limbs motor rehabilitation|During each session, the subject will perform 4 VR-based exercises that involve reaching, grasping, and intercepting virtual objects. The training will last a total of 30 min per session.
15965788|NCT03144102|Device|Anodal transcranial direct-current stimulation (tDCS)|Concurrent anodal tDCS on sensorimotor cortex on the ipsilesional hemisphere.
15965789|NCT03144102|Behavioral|Occupational Therapy for upper-limbs motor rehabilitation|During each session, the subject will perform 4 occupational therapy exercises that involve reaching, grasping, and intercepting objects. The training will last a total of 30 min per session.
15965790|NCT03144102|Device|Sham transcranial direct-current stimulation (tDCS)|Concurrent sham tDCS on sensorimotor cortex on the ipsilesional hemisphere.
15965791|NCT03144089|Device|Articulated Oral Airway|The AOA is a novel device which actively displaces the tongue, allowing for a greater cross-sectional area for mask ventilation. The AOA will be evaluated for efficacy of mask ventilation.
15965792|NCT03144089|Device|Guedel oral airway (active comparator)|The Guedel oral airway is a standard oral airway commonly used to facilitate mask ventilation. The Guedel oral airway will be evaluated for efficacy of mask ventilation.
15965793|NCT03144076|Other|RSBY Health Insurance|RSBY is a national inpatient public insurance plan in India, made available through this study to participants in Groups A, B, and C.
15965794|NCT03144050|Device|SFDI Imaging|Imaging with SFDI device
15965795|NCT03144024|Device|band implantation|
15965796|NCT03144024|Device|rigid ring implantation|
15965797|NCT03143998|Drug|MK-5172A|A single FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken once daily by mouth.
15965798|NCT03143985|Drug|Vactosertib|Vactosertib is an inhibitor of protein serine/threonine kinase activity of TGF-β receptor type 1 (TGFBR1; ALK5). Vactosertib inhibits the phosphorylation of the ALK5 substrates, Smad2 and Smad3, and the intracellular signaling of TGF-β. Dosing begins at 60mg by mouth, daily and may increase to 240mg by mouth daily in the absence of dose limiting toxicities
15965799|NCT03143985|Drug|Pomalidomide|POM, an analog of thalidomide, is an immunomodulatory agent with antineoplastic activity. Myeloma tumor cells exposed to POM, undergo growth arrest and increased apoptotic cell death. POM enhances T cell- and natural killer cell-mediated immunity and inhibit production of pro-inflammatory cytokines by monocytes. POM may be taken orally with water. Capsules should not be broken, chewed or opened. POM should be taken without food (at least 2 hours before or 2 hours after a meal). POM will be commercially available. POM will be taken by mouth at a dose of 4mg per day
15965800|NCT03143972|Drug|Dexmedetomidine|Single drug administration
15965801|NCT03143972|Drug|Remifentanil|Single drug administration
15965802|NCT03143946|Dietary Supplement|Vitamin supplement;|Vitamin K, vitamin A, vitamin D, vitamin E, nicotinamide, vitamin B12
15965803|NCT03143946|Other|Diet advice|
15965804|NCT03143933|Drug|Propofol|I.V propofol
15965805|NCT03143933|Drug|Fentanyl|
15965806|NCT03143920|Combination Product|Hyperbaric Oxygen Therapy-|Hyperbaric oxygen therapy provides 100% medical grade oxygen at 2.4 atmospheres of absolute pressure with a Class A multiple person chamber or Class B single person chamber. Hyperbaric chambers are classified as a Class II medical device and have been FDA cleared.
15965807|NCT03143907|Behavioral|Mindfulness Ambassador Council for Early Psychosis (MAC-EP)|MAC is a 12-week facilitated group mindfulness intervention promoting the development of social-emotional competence in youth created by Mindfulness Without Borders (MWB; www.mwb.org). A meditative practice, mindfulness focuses one's awareness on the present, acknowledging and accepting without judging one's feelings, thoughts, or bodily sensations. Each session has a unique focus (e.g., paying attention, practicing gratitude) and consists of facilitated group learning, discussion and mindfulness skills practice. Home assignments to help reinforce specific lesson are also assigned. MAC has demonstrated acceptability, feasibility, and promising beneficial effects in schools, and in the pilot study conducted at the Early Psychosis Program at London Health Sciences Centre in London, Ontario. Its youth-focus and emphasis on building social and emotional competencies through mindfulness make it a promising intervention for youth recovering from their first episode of psychosis.
15965808|NCT03143894|Device|tDCS|Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.
15965809|NCT03143894|Other|Sham tDCS|Sham Transcranial direct current stimulation (tDCS)..
15965810|NCT03143881|Behavioral|Education|Standardized information on the etiology of HF, mechanisms and side effects of medications prescribed, strategies for minimizing exacerbations, and warning signs of worsening clinical status will be discussed with the patient.
15965811|NCT03143868|Behavioral|Exercise Modality|The overall aim of this study is to compare how acute exercise modality (e.g. resistance exercise vs. aerobic exercise) differentially influence hormonal and behavioral indices of appetite regulation and ad libitum energy intake. Both conditions will also be compared to a non-exercise control condition.
15965812|NCT03143855|Drug|Lorcaserin|Lorcaserin will be administered at a dose of 10 mg twice daily for 5 days
15965813|NCT03143855|Drug|Placebo|Placebo will be administered twice daily for for 5 days
15965814|NCT03143842|Device|Vagus Nerve Stimulation|Delivering electrical pulses to the Vagus Nerve
15965815|NCT03143829|Other|eSSET-CINV|This intervention is an educational intervention, a serious game, which allows older adults under treatment for cancer to practice making self-care decisions for an avatar who is being sent home after their first chemotherapy treatment. This serious game is coupled with a discussion with a nurse about choices related to managing nausea and vomiting at home.
15965846|NCT03143543|Other|Group B2 Parallel Placebo|Oral placebo vs 20 mg lorcaserin
15965875|NCT03143296|Other|Simulated reverberant environment|Reverberant environments simulate real-life situations mimicking a living room, classroom and auditorium. Each simulation lasts up to 2 hours.
15965816|NCT03143816|Drug|Technosphere insulin|This multi-center study will enroll 60 patients with T1D, A1c values between 6.5 to 10%. The patients will be randomized in 1:1 fashion to either TI or NL. Patients who are randomized into the NL arm will continue using their usual prandial insulin dose before meals. Patients who are randomized into the TI arm will be instructed to dose before the meals and take necessary corrections at 1- and 2-hours after meals to optimize PPBG (Table 1B). There will be a total of 7 study visits (screening visit, randomization visit, 2 clinic, and 3 phone visits). There will be a 4-week treatment comparison between TI and NL and 1-week of post-study follow up. (Phone visit; Figure-1). Standard lab tests (A1c, complete metabolic panel {CMP}, complete blood count {CBC}) will be performed at the screening visit.
15965817|NCT03143803|Drug|Polyherbal capsule coccinia, bougainvillea, catharanthus|A unique combination of 3 herbs that lower blood sugars
15965818|NCT03143803|Drug|Placebo|Similar looking inactive powder
15965819|NCT03143790|Procedure|Extracorporeal Shockwave Terapy|Intervention is treatment with ESWT. Placebo treatment is using the same device as the active treatment, but the shock waves stopped in a non pressure-conductive filter
15965820|NCT03143777|Device|Sara Combilizer|Combined tilt table and stretcher chair
15965821|NCT03143764|Behavioral|Commuting with electrically assisted bicycles|25 participants were provided with electrically assisted bicycles fitted with GPS bike computers to record usage
15965822|NCT03143751|Drug|NaCl20% (Continuous hyperosmolar therapy)|"Early intravenous administration (<24 hours after traumatic brain injury) of NaCl20% for a minimal duration of 48 hours (continued for as long as is necessary to prevent intracranial hypertension)
~1-hour bolus (15 g if Na+ < 145 mmol/L; 7.5 g if 145 < Na+ < 150 mmol/L; or no bolus) followed by 1 g/hour as long as Na+< 150 mmol/L, reduced to 0.5 g/L if 150 < Na+ < 155 mmol/L, Discontinuation when 155 mmol/L<Na+"
15965823|NCT03143738|Procedure|continuous anesthesia of adductor canal|After subarachnoid anesthesia, but before the beginning of surgery, a catheter will be implemented to the adductor canal and infusion of 5 mL/h of 0.2 % ropivacaine will be started.
15965824|NCT03143738|Procedure|continuous anesthesia of femoral nerve|After subarachnoid anesthesia, but before the beginning of surgery, a catheter will be implemented next to the femoral nerve (below inguinal ligament) and infusion of 5 mL/h of 0.2 % ropivacaine will be started.
15965825|NCT03143738|Procedure|Spinal anesthesia|Before the beginning of surgery all patients will be anesthetised with 0.5 % hyperbaric bupivacaine (Marcaine Heavy), 2.0 - 2.5 mL solution. Pencil point spinal needle will be used.
15965826|NCT03143725|Drug|GLPG1972|Oral administration of GLPG1972 in four different treatment conditions (Treatments A throug D)
15965827|NCT03143712|Drug|GLPG1690|Oral administration of GLPG1690 in three different treatment conditions (treatment A through C)
15965828|NCT03143699|Other|Immediate Feedback|Students will be trained to measure blood pressure in the same way, with a brief 4-hour theoretical-practical intervention. After the training, students will measure the blood pressure of a standardized patient and observers will evaluate them using a checklist. After that, students from the intervention group will receive an immediate feedback based on the previous literature. Briefly, feedback will be based on what was directly observed and will be phrased in non-judgmental language, following the Pendleton model.
15965829|NCT03143686|Device|ACURATE TA™ Transapical Aortic Bioprosthesis|ACURATE TA™ Transapical Aortic Bioprosthesis is intended for subjects with severe symptomatic aortic stenosis and are considered high risk for surgical conventional Aortic Valve Replacement.
15965830|NCT03143673|Device|ACURATE TA™|ACURATE TA™ Transapical Aortic Bioprosthesis is intended for subjects with severe symptomatic Aortic Stenosis and are considered high risk for surgical conventional Aortic Valve Replacement Surgery.
15965831|NCT03143660|Behavioral|Coaching|The eight weekly 30-minute Fitline calls provide personalized behavioral counseling and coaching to guide parents in improving their child's weight-related behaviors through targeted lifestyle changes recommended by the AAP for Stage 1, Prevention Plus. Calls are scheduled at a time convenient for the parent, including nights and weekends, with one nutritionist assigned to a family for consistency.
15965832|NCT03143660|Behavioral|Materials|The workbook contains tips and practical strategies for implementing the AAP-recommended behavior changes discussed in the counseling sessions to support families in making lifestyle changes.
15965833|NCT03143647|Other|Collect a study-specific blood sample of healthy subjects|One heparin tube (4ml) and one hirudin tube (4ml) blood sample will be collected through standard venipuncture. After applying a tourniquet with moderate pressure around the arm of the patient's choice, skin will be disinfected over a suitable vein in the elbow or fore-arm. A hirudin and a heparin tube will be filled with venous blood through a single puncture with a 22 Ga needle (manufacturer, location). After release of the tourniquet, bleeding will be stopped by applying local pressure for 5 minutes with a sterile gauze.
15965834|NCT03143634|Behavioral|The Modular Protocol for Mental Health|This intervention is based on evidence-based cognitive-behavioural approaches to psychological disorders and offers a flexible approach to treatment delivery that targets the maladaptive processes common to mood and anxiety disorders.
15965835|NCT03143634|Behavioral|Treatment-as-usual|This intervention will consist of psychological therapies delivered by high-intensity therapists or clinical psychologists.
15965836|NCT03143621|Dietary Supplement|Coffee|Brewed, caffeinated coffee, 100 cc's each dose
15965837|NCT03143621|Other|Water|Tap water heated to same temperature as coffee
15965838|NCT03143608|Device|Esophyx|Laparoscopic hiatal hernia repair followed immediately by transoral incisionless fundoplication under general anesthesia using the Esophyx device
15965839|NCT03143582|Other|Running|A 13-week running program where youth run for 30 minutes twice weekly.
15965840|NCT03143569|Device|aPTT guided heparin management|post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device.
15965841|NCT03143569|Device|Anti-factor Xa guided heparin management|post-surgical implantation anti-coagulation therapy to prevent clotting in ventricular assist device
15965842|NCT03143556|Device|Magnetic stent|Patients who are undergoing renal transplant surgery for the treatment of end stage renal failure will be assigned to magnetic stent or routine stent using computer generated randomization method in the operating room. Those who receive magnetic stent would get their stent removal by magnetic device retrieval and not by routine cystoscopy.
15965843|NCT03143543|Drug|Group A Lorcaserin (10mg)|10 mg lorcaserin orally for 7 days
15965844|NCT03143543|Drug|Group A2 Lorcaserin (20 mg)|20 mg lorcaserin orally for 7 days
15965847|NCT03143530|Procedure|Pectoralis block|Pectoralis block involving injection near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior muscles (pecs II).
15965848|NCT03143530|Drug|Normal saline injection|Pectoralis block involving injection of normal saline 30ml near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior
15965849|NCT03143530|Drug|Ropivacaine Injection|Pectoralis block involving injection of ropivacaine injection 30ml of 0,25% (75 mg) near the coracoid process in the fascial planes between both the pectoralis major and minor muscles (pecs I), and the fascial plane between the pectoralis minor and serratus anterior
15965850|NCT03143517|Diagnostic Test|Stool collection|Stool sample collected by a subject who have been diagnosed with IBD, IBS or other GI disorder. The stool sample is tested in a laboratory where fecal calprotectin levels are quantified.
15965851|NCT03143504|Diagnostic Test|Skin Testing for Atopic eczema|"FTIR Spectroscopy. This will involve placing the assessment tool briefly in contact with the baby's skin on the arm and thigh.
~Transepidermal Water Loss. This will involve placing a probe on the baby's skin for approximately 60 seconds on the arm and thigh. The probe measures the rate of water loss from the baby's skin, which indicates how well it acts as a barrier.
~Collection of skin samples. This will involve collecting surface skin samples using small sticky-tape discs to collect only the very top skin cells that are already dead and about to be shed naturally by the body.
~Microbial swab. The researchers will rub the baby's skin gently with a wet sterile swab to collect a sample of the microbes on the baby's skin surface.
~Buccal swab / saliva sample. The researchers will collect a sample of the baby's saliva using a buccal swab. This sample will be used to analyse the baby's genes (DNA) to assess their inherited risk of eczema."
15965852|NCT03143491|Drug|SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment|1 mL of SOR007 applied topically to the ectocervix once-weekly for four weeks.
15965853|NCT03143478|Device|M-MARK|"M-MARK will be used by therapists for assessment of the upper limb, and stroke participants will be asked to use M-MARK whilst performing individually tailored and prescribed exercises for a minimum of 5 days/week.
~A set of tailored arm exercises using M-MARK (including targets for repetitive and functional activities) will be prescribed which the participant will be asked to practice independently at home for four weeks.
~During the four weeks, the patient (with support from their carer as required) will be encouraged to don the M-Mark garment and log-on to the M-Mark computer tablet each day to carry out their programme of exercises. They will be asked to use M-Mark to repeat as many exercise sessions per day as prescribed to them by their research therapist."
15965854|NCT03143465|Drug|Calcitonin Gene-Related Peptide|
15965855|NCT03143465|Drug|Sildenafil|
15965856|NCT03143465|Drug|Placebo|
15965857|NCT03143452|Drug|lidocaine gel|2% lidocaine gel in 1 ml syringe, applied to the eye 5 minutes before phacoemulsification
15965858|NCT03143452|Drug|tetracaine eye drop|0.5% tetracaine eye drop was given 5 minutes before phacoemulsification
15965859|NCT03143439|Behavioral|Fathers Advancing Communities Together (FACT) program|The FACT program offers fathers and their families responsible parenting, healthy relationship, and economic stability services and activities.
15965860|NCT03143426|Procedure|3D laparoscopic cholecystectomy|Laparoscopic cholecystectomy will be performed under 3D visualization as opposed to 2D visualization (conventional method). 3D supposedly provide sharper view with better depth perception and therefore might lead to reduce complication rates.
15965861|NCT03143413|Other|Ultrasonography|"Patient will be enrolled in the rheumatology department of University hospital of Clermont-Ferrand (France).
~Salivary glands ultrasonography will be performed on all patients enrolled by the same expert and blinded to the diagnosis of the patient. Echostructure of the two salivary glands will be graded 0 to 4 and the size calculated."
15965862|NCT03143400|Drug|Lactobacillus salivarius BL 3123|Two classic forms will be tested (powder and pill). An innovative galenic form (pill with retarded release), developed to enhance intestinal viability and probiotic efficacy, will also be tested.
15965863|NCT03143387|Other|Caries removal using only manual instruments|Caries removal using only manual instruments according to Atraumatic Restorative Treatment
15965864|NCT03143387|Other|Caries removal using Papacarie gel|Caries removal using a chemical-mechanical method - Papacarie gel and manual instruments.
15965865|NCT03143374|Device|[18F]T807 (also known as 18F-AV- 1451)|"experimental PET/CT scan of the brain. In this scan, imaging is done with specialized cameras that can pick up radiation signals given off by a radioactive tracer and determine where the signals come from.
~The tracer used for this study is called [18]FT807 (also known as 18F-AV-1451). [18]FT807 is a specialized radioactive PET tracer used to detect the presence of tau proteins in the brain. [18]FT807 is an experimental tracer that has been studied in patients with known or suspected Alzheimer's disease, Progressive Supranuclear Palsy (PSP) and Corticobasal Degeneration (CBS/CBD). In this study, patients will have one (1) [18F]T807 PET/CT scan performed at the University of Pennsylvania. The [18F]T807 PET/CT scan will require up to 3 hours of time, including preparation. The scan will take place using PET/CT scanners in the Perelman Center for Advanced Medicine or the Hospital of the University of Pennsylvania."
15965866|NCT03143361|Procedure|Aortic valve replacement|All surgical procedures used for both traditional and mini-invasive aortic valve replacement, as well as transcatheter valve implantation.
15965867|NCT03143348|Procedure|Single blood draw|One blood draw of 0.5 ml volume prior to discharge
15965868|NCT03143348|Procedure|Multiple blood draws|Blood draw at 6 peri-operative time points.
15965869|NCT03143348|Procedure|Multiple blood draws|Blood draw at 7 peri-operative time points
15965870|NCT03143335|Procedure|Retropectoral immediate breast reconstruction|Immediate reconstruction with the implant placed in a standard fashion, i.e. retropectoral in combination with an acellular dermal matrix.
15965871|NCT03143335|Procedure|Prepectoral immediate breast reconstruction|Immediate breast reconstruction with the implant placed prepectoral supported by acellular dermal matrix alone.
15965872|NCT03143322|Radiation|SBRT|SBRT will be added to systemic (standard) treatment of bone metastases.
15965873|NCT03143309|Behavioral|Intervention|Brief introductory session, pedometer instruction, daily pedometer use, and health messages delivered via WhatsApp 2-3 times per week.
15965874|NCT03143309|Other|Control|Non-health related messages delivered via WhatsApp 2-3 times per week.
15965876|NCT03143283|Behavioral|Safety Study Lethal Means Counseling|Clinicians provide applicable families with locking devices and handouts on safe storage of firearms and medications.
15965877|NCT03143270|Drug|Drug Eluting Bead Transarterial Chemoembolization|Hepatic embolization will occur on Day 0 of the study for all cohorts. On the day of the procedure, baseline angiography including celiac and superior mesenteric angiography will be performed to delineate arterial anatomy and blood supply to the tumor. After the entire dose has been used, the embolized vessels will be re-catheterized and embolized to stasis with Bead Block beginning with 100-300 micron spheres and using a maximum of 10 cc of any given size per vessel before moving to the next size microsphere.
15965878|NCT03143270|Drug|Nivolumab|All participants will receive at a flat dose of 240 mg IV q 12 weeks for up to one year. In cohort 1, participants will begin nivolumab two weeks (+/- 5 days) after deb-TACE every two weeks. In cohort 2, participants will begin nivolumab every 2 weeks for 1 year and undergo deb-TACE 4 weeks after the initiation of nivolumab (+/- 5 day). Nivolumab will not be dosed on the day of embolization in this cohort. In cohort 3, nivolumab will be dosed every two weeks starting 4 weeks (+/- 5 days) prior to deb-TACE and continue every 2 weeks for up to one year. Nivolumab will be dosed on the day of embolization in this cohort. It will be administered before the deb-TACE procedure.
15965879|NCT03143257|Device|Sophono Bone Conduction Hearing Systems|"The Sophono Bone Conduction Hearing Systems are a family of sound processors and accessories that operate on the principle of BC of sound vibrations. The Sophono Bone Conduction Hearing Systems transmits audio vibrations through the skin into the bone where sound is sensed by the inner ear/cochlea.
~The Sophono Sound Processor is magnetically attracted to the Magnetic Implant and Magnetic Spacer. The Magnetic Implant, which is secured to the skull bone, affixes the Magnetic Spacer to the head transcutaneously through magnetic attraction forces, and the Sound Processor is magnetically affixed to the Magnetic Spacer. Vibration from the Sound Processor is transduced through the Magnetic Spacer to the Magnetic Implant and through the bone to the inner ear."
15965880|NCT03143244|Drug|Dexmedetomidine group (D)|Patients received 1ug/kg dexmedetomidine in 50 ml saline over 10 min i.v 30 min before induction then 0.4 ug/kg/h dexmedetomidine (4ug/ml) and normal saline 0.1 ml/kg till end of surgery, using two syringe pumps one for dexmedetomidine and the other for saline
15965881|NCT03143244|Drug|Ketorolac-Midazolam group (KM)|Patients received 0.5mg/kg ketolac in 50 ml saline over 10 min before induction and 25ug/kg midazolam in 50 ml saline over 10 min i.v 30 min before induction then 50ug/kg/h of ketolac and 40ug/kg/h midazolam till end of surgery in two separate syringe pumps.
15965882|NCT03143244|Drug|Control group (Normal Saline) (C)|Patients received normal saline in two sets
15965883|NCT03143231|Other|Normal saline|The normal saline will be divided in 3ml aliquots that will be preserved in the pharmacy refrigerator between 2 and 60[0]C. Once a patient had been randomized, 6 aliquots would be prepared daily until the end of the trial.
15965884|NCT03143231|Other|Hypertonic saline|The mixture (500 ml Sodium Chloride 0.9% with 60 ml Sodium chloride 20%) will be divided in 3ml aliquots that will be preserved in the pharmacy refrigerator between 2 and 60[0]C. Once a patient had been randomized, 6 aliquots would be prepared daily until the end of the trial.
15965885|NCT03143218|Biological|RABIPUR®|Year 1 (2017) Three doses of rabies vaccine (April, May, June) Year 2 and 3 (2018/19) One dose of Hepatitis A vaccine (June)
15965886|NCT03143218|Biological|RTS,S/AS01|Year 1 (2017) Three doses of RTSS/AS01 (April, May, June) Year 2 and 3 (2018/19) One booster dose of RTSS/AS01 (June)
15965887|NCT03143218|Drug|SMC with SP+AQ|Year 1, 2 and 3(2017/18/19) Four cycles of SMC (SP+AQ) during the malaria transmission season One cycle of SMC for children above one year of age consisting of sulphadoxine - pyrimethamin (SP) 500mg/25 mg, and amodiaquine (AQ) 150mg on day 1, and AQ 150mg on days 2 and 3. Infants will receive half of these doses.
15965888|NCT03143218|Drug|SMC placebo|Year 1, 2 and 3(2017/18/19) Four cycles of SMC placebo during the malaria transmission season
15965889|NCT03143205|Behavioral|AWARENESS for Sexual Minorities|9 session, individually delivered, cognitive behavioral intervention focused on modifying sexual minority stress responses to reduce the impact of sexual minority stress experiences.
15965890|NCT03143205|Behavioral|Writing tasks|Writing sessions to explore daily activities.
15965891|NCT03143192|Combination Product|Micropulse Laser|Aflibercept injection with Micropulse laser.
15965892|NCT03143192|Device|Sham Laser|Aflibercept injection with Sham Laser
15965893|NCT03143166|Drug|Dabigatran Etexilate|Tablet, film coated
15965894|NCT03143166|Drug|Rabeprazol sodium|Tablet
15965895|NCT03143153|Biological|Nivolumab|Specified dose on specified days
15965896|NCT03143153|Biological|Ipilimumab|Specified dose on specified days
15965897|NCT03143153|Drug|Cisplatin|Specified dose on specified days
15965898|NCT03143153|Drug|Fluorouracil|Specified dose on specified days
15965899|NCT03143140|Other|PAFA|percutaneous ablation of tumor feeding artery
15965900|NCT03143140|Other|tumor ablation|ablation of tumor area directly
15965901|NCT03143114|Procedure|Myomectomy|Laparotomy then incision in the uterine wall to remove the myoma followed by closure of the uterine incision
15965902|NCT03143101|Biological|FluMist trivalent (2015-2016)|0.2 mL (total dose in both nostrils) on Days 1 and 28. Each 0.2 mL dose will contain 10^7±0.5 FFU of each vaccine strain.
15965903|NCT03143101|Biological|FluMist Quadrivalent (2015-2016)|0.2 mL (total dose in both nostrils) on Days 1 and 28. Each 0.2 mL dose will contain 10^7±0.5 FFU of each vaccine strain.
15965904|NCT03143101|Biological|FluMist Quadrivalent (2017-2018)|0.2 mL (total dose in both nostrils) on Days 1 and 28. Each 0.2 mL dose will contain 10^7±0.5 FFU of each vaccine strain.
15965905|NCT03143088|Behavioral|Medical clown|Blood pressure will be taken to children admitted to the pediatric emergency department with and without the presence of a medical clown.
15965906|NCT03143075|Dietary Supplement|Eicosapentaenoic acid enriched omega-3 fatty acids, 2 g/day|Eicosapentaenoic acid enriched omega-3 fatty acids, 2 g/day, added to pre-stabilized antidepressant medication
15965907|NCT03143062|Diagnostic Test|NEWS|NEWS
15965908|NCT03143049|Drug|PCD|"For PCD, patients will be treated as follows: PO pomalidomide 4mg from D1-21, PO cyclophosphamide 400mg on D1, 8 and 15, and PO or IV dexamethasone 40mg D1, 8, 15 and 22 in a 28-day cycle.
~Patients will be assessed every 28 days (+/- 10 days). Patients shall receive the treatment until disease progression, unacceptable toxicity as determined by treating physician, withdrawal of consent or mortality (whichever occurs first)."
15965909|NCT03143049|Drug|PD|"For PD, Patients will be treated as follows: PO pomalidomide 4mg from D1-21 and PO or IV dexamethasone 40mg D1, 8, 15 and 22 in a 28-day cycle.
~Patients will be assessed every 28 days (+/- 10 days). Patients shall receive the treatment until disease progression, unacceptable toxicity as determined by treating physician, withdrawal of consent or mortality (whichever occurs first)."
15965910|NCT03143036|Drug|Daratumumab, thalidomide and dexamethasone|"Patients will be treated with with the following schedule. IV daratumumab 16mg/kg body weight weekly for weeks 1-8 followed by daratumumab 16mg/kg body weight once every 2 weeks from weeks 9 to 24 and then daratumumab 16mg/kg once every 4 weeks from weeks 25 onwards until disease progression; PO thalidomide 100mg daily for 1 year and PO Dexamethasone 40mg (starting dose of dexamethasone is 20mg once weekly for patients >75 years old) once weekly for 1 year (13 cycles, each cycle is 4 weeks). After 1 year, patient only continue on daratumumab until progression
~Patients will be assessed every 28 days (+/-10 days)."
15965911|NCT03143023|Drug|arginine toothpaste|acid neutralizer toothpaste
15965912|NCT03143023|Drug|fluoride toothpaste|bactericidal toothpaste
15965913|NCT03143010|Drug|intrathecal Dexmedetomidine|injection of different doses of Dexmedetomidine intrathecally received 3mL (15mg) of 0.5% levobupivacaine +0.5mL normal saline.
15965914|NCT03143010|Drug|Dexmedetomidine 1.5 micrograms|injection of different doses of Dexmedetomidine intrathecally in the form of 3mL (15mg) of 0.5% levobupivacaine +0.5mLof 1.5 micrograms of Dexmedetomidine.
15965915|NCT03143010|Drug|Dexmedetomidine 3 micrograms|injection of different doses of Dexmedetomidine intrathecally in the form of 3mL (15mg) of 0.5% levobupivacaine +0.5mLof 3 micrograms of Dexmedetomidine.
15965916|NCT03143010|Drug|Dexmedetomidine 5 micrograms|injection of different doses of Dexmedetomidine intrathecally in the form of 3mL (15mg) of 0.5% levobupivacaine +0.5mLof 5 micrograms of Dexmedetomidine.
15965917|NCT03142997|Diagnostic Test|Lung ultrasound|we will perform lung ultrasound for both groups to calculate lung score.
15965918|NCT03142984|Other|Cosmetic Products|"Phase 1:
~Baby Wash & Shampoo (F# 13217-070) Baby Lotion (F# 13217-071)
~Phase 2:
~Baby Wash & Shampoo (F# 13217-070) Baby Lotion (F# 13217-071) Alternative Baby Wash & Shampoo (GTIN/UPC # 5011451106260)"
15965919|NCT03142971|Procedure|focused shock wave therapy|
15965920|NCT03142971|Procedure|ultrasound therapy|
15965921|NCT03142958|Device|Integra Cadence Total Ankle System|Primary or revision on total ankle replacement
15965922|NCT03142945|Other|Traditional Physical Therapy|Physical therapy-based interventions
15965923|NCT03142945|Other|MDT based physical therapy|MDT based physical therapy
15965924|NCT03142932|Device|Individualized carbon monoxide (iCO) monitor|a personal monitor for a breath test for carbon monoxide (CO)
15965925|NCT03142932|Other|COach2Quit smartphone application|This smartphone application works in conjunction with the iCO monitor
15965926|NCT03142932|Behavioral|Cessation counseling|The advice to quit smoking message will follow NCI's 5 A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up.
15965927|NCT03142919|Biological|Lipopolysaccharide|Lipopolysaccharide (LPS) derived from E. Coli group O 113:H10:K negative
15965928|NCT03142919|Biological|Placebo|Saline solution
15965929|NCT03142906|Diagnostic Test|Scan|The preoperative point of care ultrasound includes a protocolized focused cardiac ultrasound, lung and pleural ultrasound and a gastric volume and content ultrasound assessment, all of which will be performed as an adjunct to the anesthesiologist's assessment. The result of this ultrasound examination will be disclosed to the anesthesiologist and patient care teams. Repeat ultrasounds may be done as the patient's clinical condition changes, or as requested by the anesthesiologist or patient care team.
15965930|NCT03142893|Drug|Ketoconazole Pill|Ketoconazole pill is taken 4 times per Inpatient Stay
15965931|NCT03142893|Drug|Ganirelix|Ganirelix subcutaneous injection is administered twice per Inpatient Stay
15965932|NCT03142893|Drug|Dexamethasone|Dexamethasone Pills is taken twice per Inpatient Stay
15965933|NCT03142893|Drug|Dexamethasone Injection|Dexamethasone IV injection is given twice per Inpatient Stay
15965934|NCT03142893|Drug|Cosyntropin Injectable Product|cosyntropin injection is given twice per Inpatient Stay
15965935|NCT03142893|Drug|Recombinant Human Luteinizing Hormone|Leutinizing-Releasing Hormone is given 6 IV infusion pulses per Inpatient Visit
15965936|NCT03142893|Drug|Hydrocortisone Injection|Hydrocortisone IV push is given twice per Inpatient Visit
15965937|NCT03142893|Drug|Gonadorelin|Gonadorelin IV injection is given twice per Inpatient Stay
15965938|NCT03142893|Drug|Corticorelin|Corticorelin IV injection is given twice per Inpatient Stay
15965939|NCT03142893|Drug|Placebo oral capsule|Placebo for ketoconazole are given 4 times per Inpatient Stay
15965940|NCT03142893|Drug|Saline Solution|Saline Solution (Placebo) for Dexamethasone IV injection or hydrocortisone IV injection given up to four times per Inpatient Stay
15965941|NCT03142893|Drug|Saline Solution for Injection|Saline Solution (placebo) for ganirelix subcutaneous injection
15965942|NCT03142880|Combination Product|hyperbaric ropivacaine|We change the density of ropivacaine solution to make it into an marginally hyperbaric state or into an commonly hyperbaric state.and we hypothesized that the marginally hyperbaric ropivacaine will get a similar efficacy to commonly hyperbaric solutions but a more steadily hemodynamic status.
15965943|NCT03142867|Other|non-applicable|non-applicable
15965944|NCT03142854|Drug|Polyethylene Glycol (PEG)|participants in Group A and Low risk patients in group B are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen.
15965945|NCT03142854|Drug|Polyethylene Glycol (PEG)|High risk patients in Group B will receive 4 L Polyethylene Glycol (PEG) regimen.
15965946|NCT03142841|Other|RESCUE Problem Solving Intervention|This is an education and support intervention for caregivers of Veterans with stroke. The investigators will teach study participants about the COPE model of problem solving and guide them through the application of this model in their caregiver role. They will receive tailored stroke education.
15965947|NCT03142828|Drug|Chlorhexidine|Healing abutment with Clorhexidine
15965948|NCT03142828|Other|Placebo|Healing abutment without any antiseptic
15966026|NCT03142178|Drug|Experimental: 3VM1001 active 2g Cream 3 times daily|3VM1001 2g Cream with active ingredient administered 3 times daily
15965949|NCT03142802|Diagnostic Test|Low-dose computed tomography (LDCT)|"In phase A of the study, patients will undergo conventional CT along with low dose CT. If patients have a normal conventional CT and a satisfactory low dose CT, they will move onto Phase B of the study in which they will undergo surveillance using low-dose CT. Three outcomes are possible with low-dose CT surveillance:
~Normal LDCT:
~- Patient continues on the study (i.e. continued surveillance)
~Suspicious LDCT:
~- Will undergo conventional CT and if results are normal, patient will continue on study. If conventional CT is abnormal, they will be taken off study
~Elevated serum tumour markers or other evidence of metastatic disease:
~Patient goes off study"
15965950|NCT03142789|Drug|Initial bolus (Certa and standard catheter groups)|10 ml of ropivacaine 0,75% will be used to ensure correct position of the needle and to expand the adductor canal, followed by injection of another 10 ml of ropivacaine 0.75% via the catheter during real time US imaging to ensure correct placement of the catheter.
15965951|NCT03142789|Drug|Initial bolus (Single bolus group)|20 ml of ropivacaine 0.75%
15965952|NCT03142789|Drug|Intermittent boluses (Certa and standard catheter groups)|20 ml of ropivacaine 0.2% every 8 hour in the catheter
15965953|NCT03142789|Drug|Intermittent boluses (Single bolus group)|0.1ml of ropivacaine 0.2% every 8 hour in the sham catheter
15965954|NCT03142776|Procedure|periodontal debridement|
15965955|NCT03142776|Procedure|photodynamic therapy|
15965956|NCT03142776|Drug|systemic clarithromycin|
15965957|NCT03142763|Other|Eggs|Consumption of 3 eggs per day for breakfast, 4 weeks
15965958|NCT03142763|Dietary Supplement|Choline Supplement|Consumption of choline supplement, 1 1/2 tablet (395mg choline), with breakfast for 4 weeks
15965959|NCT03142750|Device|Gastrostomy tube dressing|Two types of dressings to secure gastrostomy tube in children
15965960|NCT03142737|Other|Red kidney bean intake|Each participant will consume 1/2 cup of cooked red kidney bean
15965961|NCT03142737|Other|Eggs intake|Each participant will consume 2 cooked large eggs.
15965962|NCT03142737|Other|Peanut butter intake|Each participant will consume 2 tablespoons of peanut butter.
15965963|NCT03142737|Other|Ground beef intake|Each participant will consume 2 ounces of 90% lean ground beef.
15965964|NCT03142737|Other|Intact beef intake|Each participant will consume 2 ounces of intact beef.
15965965|NCT03142724|Drug|[18F]MNI-968|Healthy volunteers recruited for the study will undergo a single [18F]MNI-968 injections and PET scans.
15965966|NCT03142711|Other|No Medical Intervention|Validation of phone ePRO
15965967|NCT03142698|Procedure|Quantification of hepatic steatosis|Quantification of hepatic steatosis (histology, and in MRI)
15965968|NCT03142685|Device|Bowel Ultrasound|Subjects randomized to Arm B will undergo a bowel ultrasound q24 for 48 hours after time of clinical suspicion of NEC. This is in addition to the standard of care KUBs which patients in both arms will get.
15965969|NCT03142672|Procedure|pulpotomy|vital endodontic procedure
15965970|NCT03142672|Procedure|tooth filling|tooth filling
15965971|NCT03142659|Other|registry-no intervention|registry-no intervention After filling the informed consent the patients will be evaluated for clinical history and physical examination by the nurse and a cardiologist. Then, the patients may perform the following test: ECG, Chest X-RAY, Blood test including: complete blood count, renal and liver function, electrolytes, thyroid function, cholesterol, glucose, Troponin and Brain Natriuretic Peptide
15965972|NCT03142646|Biological|IM19 CAR-T|All patients will be treated with fludarabine and cyclophosphamide for 3 days,then,CAR-T cells expressing CD19 CAR will be infused 24-96 hours later.
15965973|NCT03142620|Drug|Esomeprazole|40mg twice daily
15965974|NCT03142620|Drug|Amoxicillin-Potassium Clavulanate Combination|1000mg twice daily
15965975|NCT03142620|Drug|Clarithromycin|500mg twice daily
15965976|NCT03142620|Drug|Vitamin D3|5000IU
15965977|NCT03142607|Drug|Metronidazole gel|1% Metronidazole gel
15965978|NCT03142607|Drug|Chlorhexidine Gluconate|0.2% Chlorhexidene gluconate gel
15965979|NCT03142568|Drug|Sildenafil|Infants will be randomized using a 3:1 scheme to receive sildenafil or placebo.
15965980|NCT03142568|Other|Placebo|Infants randomized to the placebo group will receive the equivalent volume of dextrose 5% for IV use or enteral use (if receiving enteral study drug).
15965981|NCT03142555|Behavioral|Health talk plus intensive social media intervention|Subjects in this group will receive treatments including a general health education talk about smoking cessation. Subjects will also get involved in the personalized what's app interaction (up to 2 months duration) to receive social support to quit smoking. The intervention outcomes and subjects' smoking status will be followed up regularly via telephone interviews (15 - 30 minutes).
15965982|NCT03142555|Behavioral|Health talk plus less intensive social media intervention|Subjects in this group will receive treatments including a general health education talk about smoking cessation but without the information of active referral to other smoking cessation services. Subjects will receive less intensive reminders via social media. The intervention outcomes and subjects' smoking status will be followed up regularly via telephone interviews (15 - 30 minutes).
15965983|NCT03142542|Drug|ZYDENA TAB.75mg(Udenafil 75mg)|ZYDENA TAB.75mg(Udenafil 75mg): by mouth, Once daily, for 32 weeks
15965984|NCT03142542|Drug|Placebo Oral Tablet|Placebo Oral Tablet: by mouth, Once daily, for 32 weeks
15965985|NCT03142529|Drug|colon lotion|The colon lotion used in this clinic trial is a kind of hospital preparation. It is brown liquid,which consists of Rhubarb, Concha ostreae and some other traditional Chinese medicine.The colon lotion is diluted from 30ml to 150ml each time and will be used once a day for 10 days.
15965986|NCT03142516|Drug|Panitumumab|Panitumumab 6 mg/kg will be administered by intravenous (IV) infusion over 60 min on days 1 and 14 of every cycle just before administration of chemotherapy
15965987|NCT03142516|Drug|Irinotecan|Irinotecan 150 mg/m2 will be administered as IV infusion over 90 min on day 1of first treatment cycle. If tolerance of this first dose is good, it will be scaled to a full dose of 180 mg/m2 starting from the second treatment cycle
15965988|NCT03142516|Drug|Folinic acid|Folinic acid 200-400 mg/m2 will be administered as IV infusion over 2 hours on day 1
15965989|NCT03142516|Drug|5-FU|5-FU will be administered IV 400 mg/m2 bolus followed by 2400 mg/m2 IV continuous infusion over 46-48 hours on days 1 and 2
15965990|NCT03142503|Dietary Supplement|Diet + supplementation|Supplementation of 1g of fish oil, 3 time a day, and hypocaloric diet (-500 calories) for 12 weeks, to evaluate weight loss, antioxidant markers and disease activity.
15965991|NCT03142503|Dietary Supplement|Diet + placebo|Supplementation of 1g of soybean oil, 3 times a day, and hypocaloric diet (-500 calories) for 12 weeks, to evaluate weight loss, antioxidant markers and disease activity.
15965992|NCT03142503|Dietary Supplement|Placebo|Supplementation of 1g soybean oil, 3 times a day.
15965993|NCT03142490|Other|Acupuncture|Acupuncture as a complementary therapy will be done in In vitro fertilization patients of the treatment group.
15965994|NCT03142490|Other|Questionnaires|Patients in both groups will be evaluated by 4 different questionnaires (before and after 8 to 12 weeks)
15965995|NCT03142477|Other|Questionnaires|Two different quality of life questionnaires (WHOQOL-Bref and EORTC QLQ-C30) will be applied before and after treatment. No true or placebo therapeutic touch intervention will be performed.
15965996|NCT03142477|Other|Placebo therapeutic touch|Placebo therapeutic touch will be done by graduate students without any specific training. The students are instructed to perform the placebo therapeutic touch with no objective intention of improving the patient's health.
15965997|NCT03142477|Other|Therapeutic touch|Therapeutic touch will be done by therapeutic touch trained professionals graduate students without any specific training with the intention of improving the patient's health.
15965998|NCT03142464|Other|Suspension of the IV fluids|No IV fluids prescription, IV catheter filled with saline solution
15965999|NCT03142451|Drug|FMX103 minocycline foam 1.5%|Dosage form description: Foam containing minocycline HCl 1.5%. Once daily application of a sufficient amount of foam to cover the entire face. Estimated maximum is 0.5 g of drug product containing 7.5 mg (1.5% active) of minocycline. Participants will apply a small amount of the drug as a thin layer over all areas of the face. Participants should apply the drug at approximately the same time each day, about 1 hour before bedtime.
15966000|NCT03142451|Drug|Vehicle foam|Dosage form description: Foam containing minocycline vehicle foam. Once daily application of a sufficient amount of foam to cover the entire face. Estimated maximum is 0.5 g of drug product containing 0.0 mg (vehicle) of minocycline. Participants will apply a small amount of the drug as a thin layer over all areas of the face. Participants should apply the drug at approximately the same time each day, about 1 hour before bedtime.
15966001|NCT03142438|Device|F&P Seal Improvement Project|Participants will be placed on this arm for a total 14 ± 4 days from Visit 1. Participants will be using the trial full face or nasal mask during this treatment arm.
15966002|NCT03142399|Dietary Supplement|whey protein|Supplementation with whey protein isolate or maltodextrin (30 grams per day) for 12 weeks associated with supervised exercise and nutritional counseling in patients with heart failure.
15966003|NCT03142386|Other|Osteopathic manipulative treatment|
15966004|NCT03142386|Other|Physiotherapy|
15966005|NCT03142373|Other|CV4 technique|
15966006|NCT03142373|Other|RR technique|
15966007|NCT03142373|Other|Placebo treatment|
15966008|NCT03142360|Drug|Beraprost sodium (Berasil)|Within two days after successful arteriovenous graft surgery, the treatment group is randomly assigned to start taking 120 mcg of Berasil.
15966009|NCT03142347|Procedure|Remote endarterectomy|Performed open endarterectomy of the common, deep, initial of superficial femoral artery. Proximal plaque exfoliate as far as possible in the superficial femoral artery. After that, the translational and rotational motions loops under fluoroscopic guidance, continuing detachment of plaque in the antegrade direction to the distal end of plaque. Plastic of arteriotomy wounds performed patches of xenopericardium. Control patency of the arterial vessel is performed intraoperatively by X-ray angiography. When rendering residual stenosis or intimal dissection, limiting blood flow, complemented by endovascular intervention plasticity.
15966010|NCT03142347|Procedure|Remote endarterectomy + DCB balloon|Performed open endarterectomy of the common, deep, initial of superficial femoral artery. Proximal plaque exfoliate as far as possible in the superficial femoral artery. After that, the translational and rotational motions loops under fluoroscopic guidance, continuing detachment of plaque in the antegrade direction to the distal end of plaque. Plastic of arteriotomy wounds performed patches of xenopericardium. And balloon angioplasty of superficial femoral artery with DCB balloon is perform. Control patency of the arterial vessel is performed intraoperatively by X-ray angiography. When rendering residual stenosis or intimal dissection, limiting blood flow, complemented by endovascular intervention plasticity.
15966011|NCT03142334|Biological|Pembrolizumab|IV infusion
15966012|NCT03142334|Drug|Placebo (saline solution)|IV infusion
15966013|NCT03142321|Drug|Vedolizumab 300 MG Injection [Entyvio]|Vedolizumab Injection
15966014|NCT03142295|Procedure|urine transfusion|Two transfusions of 100 ml of urine within 5 days by transurethral catheterization after an antibiotic free interval of 3 days.
15966015|NCT03142282|Drug|maintenance chemotherapy|National Comprehensive Cancer Network (NCCN) or European Society for Medical Oncology (ESMO) suggested maintenance chemotherapy regimens: xeloda, bevacizumab
15966016|NCT03142282|Radiation|Consolidative Radiotherapy|Stereotacticbodyradiationtherapy (SBRT) or intensity modulated radiation therapy (IMRT) for metastatic sites (less than 5)
15966017|NCT03142269|Procedure|360°anterior capsule polishing|360°anterior capsule polishing was performed with double-ended capsule polisher
15966018|NCT03142256|Behavioral|Incentivised - Conditional Cash Transfer|Participant will be randomized to receive a cash transfer conditional on drug levels at months 1, 2, and 3 versus no cash transfer
15966019|NCT03142256|Drug|Truvada 200Mg-300Mg Tablet|Both study arms will be offered Truvada as PrEP. Only one arm will be randomized to the conditional cash transfer.
15966020|NCT03142230|Other|the laying of the gastric tube and a group using the holed baby bottle nipple, the feeding tube ideally positioned at the center of the intersection pharyngeal|The newborn then receives the care with the introduction of the gastric tube after randomization with holed baby bottle nipple
15966021|NCT03142230|Other|the laying of the gastric tube and a group with simple non-nutritive suction, the feeding tube passing next to the newborn's personal pacifier|The newborn then receives the care with the introduction of the gastric tube after randomization with the newborn's personal pacifier
15966022|NCT03142217|Other|Study of dysarthria in patients with Huntington's disease|Study of dysarthria in patients with Huntington's disease
15966023|NCT03142204|Drug|[18F]F-AraG|Single dose IV injection of [18F]F-AraG for each imaging day.
15966024|NCT03142191|Drug|CC-90001|CC-90001 is a potent, selective inhibitor of JNK.
15966025|NCT03142191|Other|Placebo|Placebo
15966027|NCT03142178|Drug|Experimental: 3VM1001 active 3g Cream 3 times daily|3VM1001 3g Cream with active ingredient administered 3 times daily
15966028|NCT03142178|Drug|Experimental: 3VM1001 active 3g Cream 4 times daily|3VM1001 3g Cream with active ingredient administered 4 times daily
15966029|NCT03142178|Drug|Placebo: 3VM1001 vehicle 2g Cream 3 times daily|3VM1001 placebo 2g vehicle Cream administered 3 times daily
15966030|NCT03142178|Drug|Placebo: 3VM1001 vehicle 3g Cream 3 times daily|3VM1001 placebo 3g vehicle Cream administered 3 times daily
15966031|NCT03142178|Drug|Placebo: 3VM1001 vehicle 3g Cream 4 times daily|3VM1001 placebo 3g vehicle Cream administered 4 times daily
15966032|NCT03142165|Drug|BMS-986263|3 weekly doses of 90 mg infused intravenous administration
15966033|NCT03142165|Other|Placebo|Placebo
15966034|NCT03142165|Drug|Diphenhydramine|50 mg intravenous administration
15966035|NCT03142165|Drug|Famotidine|20 mg intravenous administration
15966038|NCT03142139|Biological|RQ1a: Delayed vs. timely vaccination with the 1st dose of DTaP-IPV-Hib|"Children will be categorized as timely vaccinated if they receive the 1st dose within the month of scheduled vaccination:
~timely vaccinated: received 1st dose of DTaP-IPV-Hib before 4 months of age
~delayed vaccinated: did not receive the first dose of DTaP-IPV-Hib before 4 months of age."
15966039|NCT03142139|Biological|RQ1b: Delayed vs. timely vaccination with the 2nd dose of DTaP-IPV-Hib|"Children will be categorized as timely vaccinated if they receive the 2nd dose within the month of scheduled vaccination:
~timely vaccinated: received 2nd dose of DTaP-IPV-Hib before 6 months of age
~delayed vaccinated: did not receive the 2nd dose of DTaP-IPV-Hib before 6 months of age."
15966040|NCT03142139|Biological|RQ2: Vaccination with DTaP-IPV-Hib compared to being unvaccinated|"• Vaccination status will be assessed as a time dependent exposure, whereby children will be categorized as unvaccinated until date of vaccination where they will shift exposure group to vaccinated."
15966041|NCT03142126|Device|Early ambulation with Angioseal closure device|To reaffirm safety and efficacy of using Angioseal for early ambulation by patients after femoral artery arteriotomy
15966042|NCT03142100|Device|cochlear implants and hearing aids|speech perception tests and bimodal fitting
15966043|NCT03142087|Other|exercises|exercise
15966044|NCT03142074|Other|Biomechanical and microstructural analysis of ATAA|Tissue collection; microstructural testing of tissue; mechanical testing of tissue .
15966045|NCT03142074|Radiation|ECG-gated CT|Image analysis of ECG-gated CT.
15966046|NCT03142061|Procedure|Electrochemotherapy|Bleomycin plus local electroporation of cutan accessible tumor tissue in patients with advanced inoperable vulva carcinoma
15966047|NCT03142048|Other|Schools of Health for the Elderly|"The intervention School of Health for the Elderly  consists of 22 weekly group sessions of 1.5 hours each. In addition to helping participants learn about different health issues, the intervention encourages interaction among participants and works on personal skills. Furthermore, most sessions are led by professionals who are experts on the topic covered and work in the neighborhood (professionals from the health services, social services, markets or neighborhood associations), making it easier to inform participants of the neighborhood's available resources. The aim of the intervention is to decrease social isolation and loneliness and, therefore, to improve mental health, self-perceived health and wellbeing"
15966048|NCT03142035|Drug|Dienogest 2 MG|Dienogest is a fourth-generation progestin of 19-nortestosterone derivative, that has been shown to improve endometriosis associated pelvic pain. It is well tolerated with no androgenic, glucocorticoid or mineralocorticoid activity. Dienogest creates a hyperprogestogenic and hypoestrogenic environment that initially induces a secretory state and then a decidualization of the ectopic endometrium and finally its atrophy. It also inhibits aromatase and COX-2 expression as well as prostaglandin E2 production in endometriotic stromal cells. It also normalizes the activity of natural killer cells and decreases the release of interleukin-1b by macrophages. These anti-inflammatory properties further help in reducing the size of endometriotic lesions
15966049|NCT03142035|Drug|gonapeptyl|gonadotropic releasing hormone agonist
15966050|NCT03142035|Procedure|IVF/IVF+ART|In-vitro fertilization +/- assisted reproductive technology
15966051|NCT03142022|Other|No intervention - Diagnostic polysomnography at 1 year after lung transplantation|
15966052|NCT03142009|Other|Intergenerational culturally adapted curriculum|"Each session starts with a collective dinner with families eating together. Then practice their Indian and clan names. The sessions are led by facilitators in their own language or bilingually. The facilitators then divide the families into children and adult groups to address the theme of the session, and they then return together at the end of the session to share their learnings. The sessions always end with the children and adults writing in their journals which are individual pages that they then put in their curriculum binders. Families are then given their home practice, which is a task that the families do together during the intervening week. The facilitators collect the curriculum binders after each session to bring back to the families the next week."
15966053|NCT03141996|Other|Vibration to upper posterior neck muscles|Vibration to upper posterior neck muscles using a vibrational tool.
15966054|NCT03141996|Other|Standard of Care|Standard of care treatment
15966055|NCT03141983|Drug|Anakinra|Anakinra (Kineret®) is a therapeutic agent that blocks the effects of IL-1α and IL-1β by competitively binding to the interleukin-1 type I receptor (IL-1RI). It is a recombinant, non-glycosylated form of the naturally occurring human interleukin-1 receptor antagonist (IL-1Ra) but differs from human IL-1Ra in that it has the addition of a single methionine residue at the amino terminus. It is supplied commercially in single use 1 ml prefilled glass syringes as a sterile, clear, colorless-to-white, preservative free solution. Each syringe contains: 0.67 ml (100 mg) of anakinra in a solution (pH 6.5) containing sodium citrate (1.29 mg), sodium chloride (5.48 mg), disodium EDTA (0.12 mg) and polysorbate 80 (0.70 mg) in Water for Injection, USP.
15966056|NCT03141983|Drug|Placebo|Saline (0.9%) will be used as the placebo, in single use 1 ml prefilled glass syringes as a sterile, clear, colorless-to-white, preservative free solution.
15966101|NCT03141658|Drug|Placebo|Multiple doses of placebo once daily for 6 days
15966057|NCT03141970|Drug|Prednisolone|Prednisolone for 12 weeks as follows 30 mg/m2 on alternate days for 4 weeks 20 mg/m2 on alternate days for 4 weeks 10 mg/m2 on alternate days for 4 weeks
15966058|NCT03141944|Other|Starkstein scale of Apathy|"The degree of apathy will be evaluated with the Starkstein scale of Apathy"
15966059|NCT03141931|Dietary Supplement|Supplement|Concentrated Omega-3 Triglycerides-fish 332 mg Equiv. Eicosapentaenoic Acid (EPA) 134 mg Equiv. Docosahexaenoic Acid (DHA) 66.8 mg Flax Seed Oil (Linseed Oil) 334 mg Equiv. Oleic acid 58.5 mg Equiv. Linoleic acid 58.5 mg Equiv. Linolenic acid 192 mg Borago officinalis seed oil fixed (Borage) 434 mg Equiv. gamma-Linolenic acid 95.5 mg
15966060|NCT03141931|Dietary Supplement|Placebo|polyethylene glycol (500mg), oleic acid (659mg) and propylene glycol (115mg)
15966061|NCT03141918|Dietary Supplement|Curcumin|The intervention will consist of the supplementation of curcumin for 30 days. Curcumin supplementation will be done by administration of 2 doses of 500mg of the product BioMor Curcumin® which is composed of 95% standardized extract of the root extract of Curcuma longa.
15966062|NCT03141918|Other|Placebo of Curcumin|"The intervention will consist of the placebo administration curcumin for 30 days.
~The Curcumin placebo will be given in 2 doses of 500mg per day."
15966063|NCT03141905|Other|Sick-Day Protocol|Sick-Day Protocol (instructions for holding and resumption of certain medicines in the event of dehydrating illness) and IVSDRS weekly remote monitoring
15966064|NCT03141905|Other|Usual Care|Standard clinical care
15966065|NCT03141892|Device|FreeStyle Libre Flash Glucose Monitoring System|Blood Glucose Monitoring
15966066|NCT03141879|Other|HUR equipment resistance training intervention|Resistance training intervention
15966067|NCT03141866|Other|Exercise Intervention 1: Move It Or Lose It (MIOLI)|An established chair-based physical activity programme for older adults.
15966068|NCT03141866|Other|Exercise Intervention 2: Machine-based resistance training intervention|Specialised, chair-based, pneumatic resistance training equipment for older adults.
15966069|NCT03141853|Other|Equine-assisted Therapy|Participants will groom and ride horses. Horses will be kept at a walk with tasks such as serpentine, circles, and zig zags to complete. Stretching, and tasks like throwing a ball into a net from horseback will be completed
15966070|NCT03141853|Other|Arthritis Exercise Education|Standard of Care from the Arthritis Foundation - How-to Exercise With Arthritis. (n.d.). Retrieved April 18, 2016, from http://www.arthritis.org/living-with-arthritis/exercise/how-to). This intervention will consist of 6 -1 hour education sessions once a week on exercise to improve symptoms of arthritis
15966071|NCT03141840|Device|ABL01|Experimental medical device
15966072|NCT03141840|Device|Placebo|ABL01 lacking active component
15966073|NCT03141827|Drug|Insulin|Insulin 40 IU, nasal spray, single dose
15966074|NCT03141827|Drug|Placebo|Placebo, nasal spray, single dose
15966075|NCT03141801|Device|DELFI PTS Personalized Tourniquet System for Blood Flow Restriction Training|cuff is inflated to 80% of an individuals limb occlusion pressure
15966076|NCT03141801|Other|Eccentric Exercise with BLAST Leg Press System|4 sets of 10 repetitions of an eccentric leg press exercise performed at 70% of the 1 repetition maximum
15966077|NCT03141801|Other|Concentric Exercise with BLAST Leg Press System|4 sets of 10 repetitions of an concentric leg press exercise performed at 70% of the 1 repetition maximum
15966078|NCT03141788|Device|Clear Aligner|Clear Aligner used to straighten teeth to desired outcome
15966079|NCT03141775|Other|Treatment of CDI|Treatment (e.g. antibiotics, fecal microbiota transfer (FMT), probiotics) for patients with Clostridium difficile associated diarrhea
15966084|NCT03141723|Other|KMC & WHO protocol (0-1 hour)|WHO thermoregulation care - warm delivery rooms, immediate drying after birth, early and exclusive breastfeeding, postponement of bathing and weighing, and appropriate bundling.
15966085|NCT03141723|Other|KMC, WHO protocol & bag (0-1 hour)|In addition infants will be placed in a plastic bag (clear polyethylene nonmedical low-cost [3 cents per bag] linear low-density bag measuring 10 × 8 × 24 in. and 1.2 mil thick) that will cover the infant's torso and lower extremities.
15966086|NCT03141723|Other|KMC & WHO protocol (1-24 hours)|WHO thermoregulation care - warm delivery rooms, immediate drying after birth, early and exclusive
15966087|NCT03141723|Other|KMC, WHO protocol & bag (1-24 hours)|In addition infants will be placed in a plastic bag (clear polyethylene nonmedical low-cost [3 cents per bag]
15966088|NCT03141710|Dietary Supplement|20 ml of prebiotic per day|12 volunteers will take 20ml of prebiotic per day for 12 weeks
15966089|NCT03141697|Device|Carbon Dioxide|Insufflation of Carbon Dioxide
15966090|NCT03141697|Device|Room air|Insufflation of room air
15966091|NCT03141684|Drug|Atezolizumab|Given IV
15966092|NCT03141684|Biological|Bevacizumab|Given IV
15966093|NCT03141671|Drug|GnRH|-blocks the function of hormones including testosterone which prostate cancer uses to grow and spread
15966094|NCT03141671|Drug|Bicalutamide|-blocks the function of hormones including testosterone which prostate cancer uses to grow and spread
15966095|NCT03141671|Radiation|Salvage radiation|Radiation
15966096|NCT03141671|Drug|Abiraterone|-blocks the function of hormones including testosterone which prostate cancer uses to grow and spread
15966097|NCT03141671|Drug|Prednisone|Prednisone is a corticosteroid. It prevents the release of substances in the body that cause inflammation. It also suppresses the immune system.
15966098|NCT03141671|Drug|Apalutamide|-blocks the function of hormones including testosterone which prostate cancer uses to grow and spread
15966099|NCT03141658|Drug|TS-134|Multiple dose titrations from 10 mg to 20 mg once daily for 6 days
15966100|NCT03141658|Drug|TS-134|Multiple dose titrations from 10 mg to 60 mg once daily for 6 days
15966103|NCT03141645|Other|Fluid loading|Patients in the preoperative intravenous fluid loading group (group F) will receive ringer lactate solution 10ml/kg in 15 minutes before starting operation.
15966104|NCT03141645|Drug|Ondansetron|Patients in the ondansetron group (group O) will receive an 8 mg of intravenous ondansetron in 15 minutes before finishing operation
15966105|NCT03141632|Drug|Dulaglutide|Evaluation visit with assessment of fluid intake
15966106|NCT03141632|Other|Placebo|Evaluation visit with assessment of fluid intake
15966107|NCT03141593|Drug|Vitamin D: liquid form, start weekly|Patient will start treatment with weekly schedule, and switch after 3 months to monthly schedule for another 3 months.
15966108|NCT03141593|Drug|Vitamin D: liquid form, start monthly|Patient will start treatment with monthly schedule, and switch after 3 months to weekly schedule for another 3 months.
15966109|NCT03141593|Drug|Vitamin D: solid form, start weekly|Patient will start treatment with weekly schedule, and switch after 3 months to monthly schedule for another 3 months.
15966110|NCT03141593|Drug|Vitamin D: solid form, start monthly|Patient will start treatment with monthly schedule, and switch after 3 months to weekly schedule for another 3 months.
15966111|NCT03141580|Diagnostic Test|Near-infrared spectroscopy and intravascular ultrasound (NIRS-IVUS)|Examination of the extracranial portion of the internal and common carotid artery with pre-existing stent with NIRS-IVUS.
15966112|NCT03141554|Drug|1% Betadine® PVP-I based mouth wash and gargle,|1% Betadine® PVP-I based mouth wash and gargle
15966113|NCT03141554|Drug|0.2% Chlor-Rinse™ Chlorhexidine based mouth wash|0.2% Chlor-Rinse™ Chlorhexidine based mouth wash
15966114|NCT03141554|Drug|Normal saline gargle|Normal saline gargle
15966115|NCT03141541|Behavioral|Group based pain management intervention|The intervention is delivered as six separate sessions of each two hours duration over a four month period. The sessions are managed by a multidisciplinary team from the Spine Center, led by a psychologist. Before the first session, each patient in the intervention group participates in an individual consultation with the psychologist or nurse, with the aim of matching expectations for the group intervention, and hereby ensure the patients compliance throughout the intervention.
15966116|NCT03141528|Other|Self-learning|Training without supervision
15966117|NCT03141528|Other|Instructor-led learning|Supervision by a tutor (either general practitioner or medical student, all trained in CPR teaching)
15966118|NCT03141515|Device|Lung ultrasound|Lung ultrasound examination at two different times-point immediately after induction and after recruitment maneuver to monitor lung aeration.
15966119|NCT03141502|Device|Skin stretching device (SSD)|By making use of skin viscoelasticity, the special metal crochet of SSD would be embedded in both sides skin of the wound. Multiple cycles of stretching and relaxing wound lead to extended skin, changing the high tension incision into a low tension incision and facilitating the direct suture.
15966120|NCT03141502|Procedure|Skin grafting|the standard technique of skin grafting after wound preparation.
15966121|NCT03141489|Dietary Supplement|Tubefeeding|NICE guidelines regarding refeeding syndrome, based on a very cautious refeeding regime reaching estimated calorie and protein needs within 7 days, compared to a protocol at Diakonhjemmet Hospital using a higher starting rate, reaching estimated needs within 3 days.
15966122|NCT03141476|Drug|Cefuroxime 1,5g|Patients with BMI of <30kg/m*m: 1,5 g Cefuroxime
15966123|NCT03141476|Drug|Cefuroxime 3g|Patients with BMI of 30-50kg/m*m: 3g Cefuroxime
15966124|NCT03141476|Drug|Cefuroxime 4,5g|Patients with BMI of >50kg/m*m: 4,5 g Cefuroxime
15966125|NCT03141463|Biological|Vvax001 therapeutic cancer vaccine|Vvax001 is a vaccine consisting of a replication-incompetent Semliki Forest Virus (SFV) vector encoding HPV-derived tumor antigens. Patients will receive three consecutive doses, with an interval of 3 weeks.
15966126|NCT03141437|Other|Best Practice|Receive standard of care
15966127|NCT03141437|Other|Educational Intervention|Receive educational materials
15966128|NCT03141437|Other|Internet-Based Intervention|Use decision-making website
15966129|NCT03141437|Other|Questionnaire Administration|Ancillary studies
15966130|NCT03141424|Other|Tapering of ICS treatment|Tapering of ICS treatment over 8 weeks. Follow-up over 52 weeks in total. Dosis reduction of 50% in ICS treatment for 8 weeks, followed by total ICS removal. Other inhaled asthma medication remains unchanged during the entire study period.
15966131|NCT03141398|Diagnostic Test|Continuous Glucose Monitoring (CGM)|Where a pager-sized device fixed to the patient's forearm by a diabetic educator and it will connect to his/her body with the sensor, which measures blood glucose for three days. Patients' may experience little pain from needle prick when a sensor is introduced.
15966132|NCT03141398|Diagnostic Test|Oral Glucose Tolerance Test (OGTT)|Oral glucose tolerance test requires the patient to be fasting and checking of blood sugar after 8 to 10 hours overnight fasting the blood sugar will be checked three times When you arrive to the lab then twice one hour, apart you can have pain due to needle prick or little bleeding at the puncture site.
15966133|NCT03141398|Diagnostic Test|T2* MRI of the Pancreas|MRI [Magnetic resonance imaging] of the pancreas which is safe and takes around 30 minutes.
15966134|NCT03141385|Other|remote ischemic preconditioning|Remote ischemic preconditioning (RIPC) will be induced after the general anesthesia prior to the cardiopulmonary bypass by four cycles of right limber ischemia (5-min blood pressure cuff inflation to a pressure of 200mmHg or a pressure that is 50 mmHg higher than SAP and 5-min cuff deflation)
15966135|NCT03141385|Other|Control|Four cycles of right upper limb pseudo ischemia and reperfusion, which will be induced by 5-minute blood pressure cuff inflation to a low pressure of 20 mmHg followed by 5-minute cuff deflated.
15966136|NCT03141372|Device|Void Trial using Foley catheter|A void trial is a test to ensure that a subject does not have urinary retention after a surgical procedure. In an autofill void trial, the subject is allowed to void after surgery and the amount of resulting urine and the amount of urine still remaining in the bladder are measured. In a backfill void trial, water is instilled into the bladder, the foley is removed, and the subject is then allowed to urinate. Again, the amount of urine resulting and the amount of urine still in the bladder are measured.
15966137|NCT03141359|Radiation|SBRT|Primary tumor SBRT
15966138|NCT03141359|Drug|Carboplatin|concurrent chemotherapy
15966139|NCT03141359|Drug|Paclitaxel|concurrent chemotherapy
15966140|NCT03141359|Drug|cis Platinum|concurrent chemotherapy
15966141|NCT03141359|Drug|Etoposide|concurrent chemotherapy
15966144|NCT03141346|Behavioral|Sugar reduction health education program|A health education program incorporating sugar reduction education and monitoring provided by a trained health educator over 24 months. The intervention program will be delivered by the health educator during in-person home visits, or virtually via phone or video calls.
15966145|NCT03141346|Behavioral|Control health education program|Control health education program provided by a trained health educator over 24 months. The intervention program will be delivered by the health educator during in-person home visits, or virtually via phone or video calls.
15966146|NCT03141346|Other|Home water delivery|Home delivery of bottled water administered over 24 months
15966147|NCT03141333|Behavioral|Teleintervention|Participants of this group will have access to the following sections in the web plate-form: information, forum, chat and live online consultation. The teleintervention consists of having access to the forum, chat and live online consultation sections of the web plate-form.
15966148|NCT03141320|Other|Interview/observation of social media comments|Interview with pregnant or postnatal women and observation of relevant social media comments
15966149|NCT03141307|Behavioral|EICI Movie|The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by watching a brief video.
15966150|NCT03141307|Behavioral|EICI App|The purpose of this intervention is to improve comprehension about broad consent for future biobank-dependent research by exploring an educational app.
15966151|NCT03141307|Behavioral|Control|Standard of care, paper-based brochure
15966152|NCT03141294|Procedure|reformative dilation technique|reformative dilation technique was used when operating tracheostomy
15966153|NCT03141281|Behavioral|BrainHQ|BrainHQ
15966154|NCT03141281|Behavioral|Rise of Nations|Rise of Nations
15966155|NCT03141281|Behavioral|IADL Training|IADL Training
15966156|NCT03141281|Behavioral|Active Control|Puzzle solving
15966157|NCT03141268|Diagnostic Test|Lactulose breath test|Lactulose 0.67 mg/mL, dose 15 mL (10 grams). No contaminants of lactose. Pharmacy quality.
15966158|NCT03141255|Device|IVTM™ System|TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter.
15966159|NCT03141255|Device|Quattro® Catheter|TH will be initiated and maintained for 24 hours using the IVTM™ System and the Quattro® Catheter. After 24 hours of maintained TH, patients will be rewarmed to normal body temperature using the same Quattro® Catheter.
15966160|NCT03141242|Behavioral|ENACT group visit|Participation in two 2 hour group visits about advance care planning.
15966161|NCT03141242|Behavioral|Mailed Resources|Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider.
15966162|NCT03141229|Behavioral|Mindfulness based stress reduction|
15966163|NCT03141216|Device|VCV+PSV|invasive mechanical mechanical modes by volume cycling and by pressure support which the patients will be submitted to before weaning. Post-operative mechanical ventilation average time: 6 hours after ICU admission.
15966164|NCT03141216|Device|PCV+PSV|invasive mechanical mechanical modes by pressure cycling and by pressure support which the patients will be submitted to before weaning. Post-operative mechanical ventilation average time: 6 hours after ICU admission.
15966165|NCT03141203|Drug|Romidepsin|10mg vial for Injection
15966166|NCT03141203|Drug|Carfilzomib|60mg vial for injection
15966167|NCT03141190|Behavioral|Mindfulness Based Stress Reduction - modified|already described
15966168|NCT03141190|Behavioral|Active listening and reading|group reading, listening and discussion of articles pertaining to the development and experience of the surgical personality
15966173|NCT03141164|Other|computerized training|Computerized training
15966174|NCT03141151|Behavioral|COACH: Healthy Bodies|Staged intensity behavioral intervention focusing on healthy lifestyles in the context of family.
15966175|NCT03141151|Behavioral|COACH: Strong Minds|School Readiness Intervention focusing on literacy and parent skills
15966176|NCT03141138|Biological|TDENV-PIV|Dosage: 0.5 mL of DENV serotypes 1-4 (4 µg / serotype) in alum adjuvant Mode of administration: intramuscular (IM) into the subject's upper arm, deltoid area of the subject's arm; vaccination will be given in the non-dominant arm whenever possible
15966177|NCT03141138|Biological|TDENV-LAV F17|Dosage: 0.5 mL of the post-transfection LAV F17 vaccine Mode of administration: subcutaneously into the upper-outer triceps/deltoid area of the subject's arm; vaccination will be given in the non-dominant arm whenever possible.
15966178|NCT03141125|Other|Physalis angulata ethanol extract|Ethanol extract of physalis angulate Linn with dosage of 3x250 mg/day given orally for 3 months
15966179|NCT03141125|Other|Placebo|No active component at the same dosage of 3x250 mg/day given orally for 3 months
15966180|NCT03141112|Procedure|renal replacement therapy|
15966181|NCT03141099|Other|Low normal MAP|The patients are randomized to recieve a Phillips M1006B blood pressure measuring module, offset by +10 %. All patients will target a MAP of 70, but due to the offset module, the patients will target an actual blood pressure of 63 mmHg.
15966182|NCT03141099|Other|High normal MAP|The patients are randomized to recieve a Phillips M1006B blood pressure measuring module, offset by -10 %. All patients will target a MAP of 70, but due to the offset module, the patients will target an actual blood pressure of 77mmHg.
15966183|NCT03141099|Other|Low normal PaO2.|The patients are randomized to a PaO2 target of 9-10 kPa (open-label).
15966184|NCT03141099|Other|High normal PaO2|The patients are randomized to a PaO2 target of 13-14 kPa (open-label).
15966185|NCT03141086|Drug|LML134|LML134
15966186|NCT03141086|Drug|Placebo|placebo
15966187|NCT03141073|Drug|HMS5552|BID oral administration
15966188|NCT03141073|Drug|Placebo|BID oral administration
15966189|NCT03141060|Drug|Delamanid|Administered orally; dosing will be based on participants' age and weight.
15966190|NCT03141060|Drug|Optimized multidrug background regimen (OBR) for children with MDR-TB|Non-study prescribed OBR will vary according to local, national, and/or international guidelines for treatment of children with MDR-TB. Administered in addition to DLM for 24 weeks.
15966191|NCT03141047|Other|Lifespan Integration|A protocol based psychological treatment method
15966192|NCT03141034|Drug|Irinotecan|-Irinotecan is commercially available and will be billed to insurance.
15966193|NCT03141034|Drug|Ramucirumab|-Ramucirumab will be provided free of charge by Eli Lilly and Company.
15966194|NCT03141034|Genetic|Blood for angiome profiling|-Before treatment on cycle 1 day 1, cycle 5 day 1, cycle 9 day 1, and end of treatment
15966195|NCT03141034|Genetic|Blood for cfDNA|-Before treatment on cycle 1 day 1, cycle 3 day 1, cycle 5 day 1, cycle 7 day 1, cycle 9 day 1, and end of treatment
15966196|NCT03141008|Other|Fibroscan changes with different diets|Observational study of liver fat and stiffness and cardiometabolic parameters comparing two different standard of care dietary regimens
15966197|NCT03140995|Behavioral|Walking Programme|The programme will be devised using incremental targets for daily walks based on the 6-20 Borg of rating of perceived exertion scale (Borg RPE). They will be instructed that they should be moderately short of breath on exertion i.e. unable to comfortably hold a conversation while walking
15966198|NCT03140982|Diagnostic Test|FOUR coma scale and frontal espectrograpy evaluation|systematic evaluation using the validated FOUR coma scale during propofol administration
15966199|NCT03140969|Drug|QR-110|RNA antisense oligonucleotide for intravitreal injection
15966200|NCT03140956|Drug|Levodopa, carbidopa, ODM-104|Crossover design. Study treatments will be administered in randomized order 4 times a day.
15966201|NCT03140943|Drug|Carfilzomib, Thalidomide and Dexamethasone|"Carfilzomib will be given on days 1,2,8,9,15,16 in a 4-week (28 day) cycle during induction cycles 1-12, followed by days 1,2,15,16 in a 4-week cycle during maintenance cycles 13-18 (section 4.0) Dexamethasone, 40mg po will be given on days 1,8,15, 22 in a 4-week cycle during induction cycles 1-12, followed by days 1,15, in a 4-week cycle during maintenance cycles 13-18.
~Thalidomide, 100mg po will be given daily during induction cycles 1-12 only."
15966202|NCT03140930|Dietary Supplement|Tastants duodenal|Duodenal infusion of combination of tastants (sweet, bitter and umami)
15966203|NCT03140930|Dietary Supplement|Tastants ileal|Ileal infusion of combination of tastants (sweet, bitter and umami)
15966204|NCT03140930|Dietary Supplement|Placebo duodenal|Duodenal infusion of placebo (tap water)
15966205|NCT03140930|Dietary Supplement|Placebo ileal|Ileal infusion of placebo (tap water)
15966206|NCT03140917|Diagnostic Test|Multimodal liver function assessment|HBS, MRI, CE-CT and ICG
15966207|NCT03140904|Other|Standard weekly visits|Distribution of the therapeutic feeding rations, as well as medical and anthropometric surveillance, will take place on a weekly basis at the outpatient therapeutic feeding center according to the random assignment of the site, until discharge
15966208|NCT03140904|Other|Monthly visits|Distribution of the therapeutic feeding rations, as well as medical and anthropometric surveillance, will take place on a monthly basis at the outpatient therapeutic feeding center according to the random assignment of the site, until discharge
15966209|NCT03140891|Device|NHFOV|NHFOV is used as the noninvasive mode after extubation
15966210|NCT03140891|Device|NCPAP|NCPAP is used as the noninvasive mode after extubation
15966211|NCT03140878|Dietary Supplement|LGG|LGG is dissolved in water and consumed at one occasion (either at visit 2 or 3)
15966212|NCT03140878|Dietary Supplement|Placebo|Placebo is dissolved in water and consumed at one occasion (either at visit 2 or 3)
15966213|NCT03140852|Behavioral|Mind Over Matter; Healthy Bowels, Healthy Bladder|This three-session workshop is based on proven principles of behavior change addressing urinary and bowel continence self-management and health education and has been developed specifically for administration to women age 50 and older in senior centers.
15966214|NCT03140839|Behavioral|Imaginal Rescripting|A stand-alone single session intervention for social anxiety disorder
15966215|NCT03140839|Behavioral|Imaginal Exposure|A stand-alone single session intervention for social anxiety disorder
15966216|NCT03140839|Other|Supportive Counselling|Non-specific talk therapy focused on non-directive and empathic listening and on supporting patients' existing coping skills and strategies.
15966217|NCT03140826|Drug|meropenem|Antibiotics to treat infections.
15966218|NCT03140813|Drug|AZD7325 (High-Dose)|15mg PO BID
15966219|NCT03140813|Drug|AZD7325 (Low-Dose)|5mg PO BID
15966220|NCT03140813|Drug|Placebo oral capsule|Placebo will be dosed similar to AZD7325, in terms of dosage form, frequency and duration.
15966221|NCT03140800|Device|intrauterine device|a method of contraception inserted in the uterus
15966222|NCT03140787|Drug|Nasal Spray of Lidocaine HCL|This spray consists of lidocaine hydrochloride-epinephrine hydrochloride
15966223|NCT03140787|Drug|Infiltration injection of Lidocaine HCL|This is the ordinary method of establishing anesthesia for patients undergoing dental treatment for caries.
15966224|NCT03140774|Biological|Previously exposed to Ebola vaccine|Exposure of interest: participants must have had one or more previous Ebola vaccines, Ad26.ZEBOV , MVA-BN-Filo or r-VSV-ZEBOV to enter the study.
15966225|NCT03140748|Other|To evaluate the initial levels and kinetics of serum β-D-glucan|To evaluate the initial levels and kinetics of serum β-D-glucan during fungal peritonitis compared to a control group of yeast-free peritonitis
15966226|NCT03140735|Other|Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction|Study the relationship between the arterial rigidity of large vessels and the presence and severity of degenerative aortic constriction
15966227|NCT03140735|Other|Control group without heart disease|Control group without heart disease
15966228|NCT03140722|Drug|vadadustat|vadadustat
15966229|NCT03140722|Drug|epoetin alfa|epoetin alfa
15966230|NCT03140709|Drug|Oxytocin|"Induction-Vaginal Delivery: Begin at 1mU/min IV infusion and increase by 2mU/30min q30min to a max of 30mU/min. Postpartum infusion adjusted to 2U/hr.
~Cesarian Delivery: 1U bolus via IV at delivery, followed by 7.5U/hr up to 30U/hour max depending on uterine tone. Postpartum infusion adjusted to 2U/hr"
15966236|NCT03140657|Drug|Nanocurcumin|Nanocurcumin capsules (the formulation of curcumin nanoparticles, Exirnanosina). Subjects randomized to Nanocurcumin Arm will receive 80 mg/day for 4 months
15966237|NCT03140657|Drug|Placebo|Subjects randomized to Placebo Arm will receive placebo in the form of capsules for 4 months
15966238|NCT03140644|Other|Patients with thoracic sarcoidosis|Ultra-low dose CT scan and MRI with UTE
15966239|NCT03140631|Drug|Protamine Sulfate|Protamine sulfate is a highly basic protein that forms stable compounds with acidic heparin to rapidly neutralize the anticoagulation effects.
15966240|NCT03140618|Other|The light and environment project in psychiatric inpatient care|"Complete rebuilding of a hospital ward.
~The ward layout is remodeled and different devices and services are installed such as light, sound, and color settings, increased opportunities for physical activity, social harmony, privacy, peace, and quiet. A comfort room and a activity room will be built."
15966241|NCT03140592|Procedure|Biopsy|Two extra EUS guided pancreatic biopsies collected for only research purposes.
15966242|NCT03140579|Other|APRV|Airway pressure release ventilation is a method of inverse ventilation, where high levels of positive end expiratory pressure are maintained to optimise oxygenation with brief releases of pressure to allow ventilation and release carbon dioxide. It is an approved and frequently used method of ventilation.
15966243|NCT03140566|Diagnostic Test|Ultrasound evaluation of the inferior vena cava diameter|Treatment will be guided by clinical assessment and ultrasound evaluation of the inferior vena cava (IVC) diameter. Decongestion should lead to maximal IVC diameter ≤2.1 cm and IVC collapsibility index >50% in addition to relief of symptoms and signs of congestion before discharge.
15966244|NCT03140566|Diagnostic Test|Sham ultrasound evaluation of the inferior vena cava diameter|Teatment guided by clinical assessment alone. Decongestion should lead to relief of symptoms and signs of congestion before discharge. IVC ultrasound evaluation is performed, but results are not reported to treating physicians.
15966245|NCT03140553|Drug|TCH (docetaxel/carboplatin/trastuzumab) versus EC-TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab)|TCH (docetaxel/carboplatin/trastuzumab) versus EC followed by TH(epirubicin/cyclophosphamide followed by docetaxe plus trastuzumab) as Neoadjuvant Treatment for HER2-Positive Breast Cancer
15966246|NCT03140540|Other|TEE guided fluid therapy will be administered|Transesophageal echocardiography will be used to guide the fluid therapy. Velocity time integral of aorta <20 ,200ml colloid bolus to be administered.
15966247|NCT03140540|Other|Stroke volume variation guided intravenous fluid.|Active Comparator: Group A control group (SVV guided fluid ) Stroke volume variation guided intraoperative intravenous fluid will be administered. SVV >10, 200 ml of colloid bolus to be given
15966248|NCT03140527|Drug|PTI-801|Active
15966249|NCT03140527|Drug|Placebo|Placebo
15966250|NCT03140527|Drug|PTI-808|Active
15966251|NCT03140527|Drug|Placebo|Placebo
15966252|NCT03140514|Drug|Rejection treatment according to clinical standard-of-care|Standard-of-care treatment is based on the severity and phenotype of biopsy-proven rejection
15966253|NCT03140501|Device|"Mobile application (app)"|"The self-management app has 3 main features: 1) SCI-specific education modules; 2) a circle-of-care in which the users select health allies (formal and informal caregivers); and 3) a variety of tools to assist with goal identification, symptom/behaviour tracking, etc. The intervention will involve 5-6 contacts that occur over a 3-month period and ongoing use of the app. There will be 1 to 2 in-person sessions, where the principles of self-management are reviewed, self-management goals are identified, and features of the app are explained. Over the next month, there will be 2 follow-up contacts to review any questions/issues participants have. Participants can set additional goals during this time. Over the last 2 months, there will be monthly contacts to address the same issues."
15966254|NCT03140488|Drug|Oxytocin|Patients will be randomized to low dose or high dose oxytocin for induction of labor.
15966255|NCT03140449|Drug|Rapamycin|"topical rapamycin (0.1%) or calcitriol (3 mcg/g) single-agent therapy versus their combination were applied twice a day by a left-right randomized, split-face comparison for 12 weeks.
~In period 2, the patients entered an open-label study and were reassigned to use the more effective ointment on both cheeks for another 12 weeks (week 13-24)."
15966256|NCT03140449|Drug|Calcitriol|"topical rapamycin (0.1%) or calcitriol (3 mcg/g) single-agent therapy versus their combination were applied twice a day by a left-right randomized, split-face comparison for 12 weeks.
~In period 2, the patients entered an open-label study and were reassigned to use the more effective ointment on both cheeks for another 12 weeks (week 13-24)."
15966257|NCT03140449|Drug|Rapamycin-calcitriol combination|"topical rapamycin (0.1%) or calcitriol (3 mcg/g) single-agent therapy versus their combination were applied twice a day by a left-right randomized, split-face comparison for 12 weeks.
~In period 2, the patients entered an open-label study and were reassigned to use the more effective ointment on both cheeks for another 12 weeks (week 13-24)."
15966258|NCT03140436|Drug|sodium bicarbonate powders with grain size 65 µm|sodium bicarbonate powders with grain size 65 µm
15966259|NCT03140436|Drug|sodium bicarbonate powders with grain size 40 µm|sodium bicarbonate powders with grain size 40 µm
15966260|NCT03140423|Drug|Arm 1. Routine Care (Mupirocin/CHG)|The intervention / decolonization regimen will consist of 5 days of topical intranasal mupirocin ointment (bilateral nares, twice daily) on ICU admission, in the context of continued daily baths with 2% chlorhexidine cloths.
15966261|NCT03140423|Drug|Arm 2. Iodophor/CHG Decolonization|The intervention / decolonization regimen will consist of 5 days of topical intranasal iodophor (10% povidone-iodine nasal swabs) (bilateral nares, twice daily) on ICU admission, in the context of continued daily baths with 2% chlorhexidine cloths.
15966262|NCT03140410|Other|Antibiotic resistance|"Test for susceptibility to linezolid using phenotypic tests, according to guidance from EUCAST group.
~Screening for the presence of crf gene, and mutations associated"
15966263|NCT03140397|Dietary Supplement|Placebo|
15966264|NCT03140397|Dietary Supplement|6-prenylnaringenin|
15966265|NCT03140397|Dietary Supplement|8-prenylnaringenin|
15966266|NCT03140384|Biological|Assess the efficacy and side effects of Misoprostol according to the route of administration|Assess the efficacy and side effects of Misoprostol according to the route of administration
15966267|NCT03140371|Dietary Supplement|High energy high protein peptide feed study|"Each patient will receive the high energy, high protein peptide-based feed for a period of up to 4 weeks (28 days). The feed will be available as an enteral tube feed in a 500ml bottle, and as a Vanilla flavoured oral nutritional supplement in a 200ml plastic bottle. The appropriate feed presentation (tube feed or oral nutritional supplement) and prescription will be determined on an individual basis by the Dietitian responsible for the patient's nutritional management, based on the patient's clinical requirement and preference, and the Dietitian's clinical judgement.
~The study feed is classed as a 'Dietary Food for Special Medical Purposes' (EC Directive 1999/21/EC, 1999) ."
15966268|NCT03140358|Drug|Atropine sulfate 0.01%|Atropine 0.01%
15966269|NCT03140358|Drug|Placebo|placebo
15966270|NCT03140332|Other|Scannographic evaluation of the tumor response performed with mRECIST criteria after 3 months of treatment with sorafenib|To evaluate the association between tumor perfusion criteria (blood flow, blood volume, mean transit time, capillary permeability) at the initial perfusion scan and tumor control according to the mRECIST criteria after 3 months of treatment with sorafenib.
15966271|NCT03140319|Biological|Fibroblast|Transplantation of 20 million cell by three injection
15966272|NCT03140319|Biological|Placebo|Injection of Placebo
15966273|NCT03140306|Diagnostic Test|Patients who have had split dose CT|Computed tomography
15966274|NCT03140293|Drug|Lidocaine injection|Injectable anesthesia is 1-2mL of 2% lidocaine via a 22 gage needle, given at the anticipated site of CVS needle puncture immediately before procedure.
15966275|NCT03140293|Drug|Gebauer Ethyl Chloride Spray|Gebauer Ethyl Chloride Spray is a topical anesthetic spray which is sprayed continuously for 3-7 seconds from a distance of 3-9 inches at the site where the chorionic villus sampling is expected to take place.
15966276|NCT03140280|Drug|Freeze-Dried Black Raspberry Powder|25 gm (2x/day) of freeze-dried black raspberry powder taken orally in 8 ounces of water for 12 weeks. If the patient is tolerating BRBs well and is benefiting from therapy, he or she will continue treatment for a total maximum of 48 weeks.
15966277|NCT03140267|Diagnostic Test|Difficult to wean patients|Subjects will be following during 18 hours in an invasive mechanical ventilation in a controlled mode. After failure of first single breath trial during 2 hours and presence of sevrability criterias defined by the European consensus conference in 2007, Maximal Inspiratory Pressure and Peak Pressure will be measure.
15966278|NCT03140254|Drug|Chlorhexidine gluconate|
15966279|NCT03140254|Drug|N,N'-(1,10-decanediyldi-1(4H)-Pyridinyl-4-ylidene)-Bis-(1-octanamine) Dihydrochloride|
15966280|NCT03140254|Drug|Placebo|
15966281|NCT03140241|Procedure|PDR measurement|"PDR measurement at two standardized times perioperatively:
~: anesthetized subject by propofol sedation until sedation depth monitor NeuroSense® (NeuroWave Systems Inc, Cleveland, OH) between 40-50
~: administration of remifentanil via effect site target concentration (Minto-model) at 5 ng/ml, in the absence of adjustments in sedation depth"
15966282|NCT03140228|Device|I-Gel|I-gel is the single use supraglottic airway from intersurgical, UK (Intersurgical Ltd, Wokingham, Berkshire, UK) with an anatomically designed mask made of a gel like thermoplastic elastomer to fit over perilaryngeal and hypopharyngeal structures. It is designed to separate the gastrointestinal and respiratory tracts and also allow a gastric tube to be passed into the stomach.
15966283|NCT03140228|Device|LMA|The AmbuAuraOnce (Ambu A/S, Ballerup, Denmark) is a supraglottic airway device with an inflatable cuff. It is a disposable device as well, but unlike I-gel, it does not feature a gastric channel.
15966284|NCT03140215|Device|laryngeal mask insertion (Baska)|
15966285|NCT03140215|Device|laryngeal mask insertion (I-gel )|
15966286|NCT03140202|Device|CPRmeter (feedback device) with feedback|Participants have a real time feedback and record.
15966287|NCT03140202|Device|CPRmeter (feedback device) without feedback|Participants have a real time record without feedback.
15966288|NCT03140176|Drug|Sunitinib|Sunitinib is an FDA approved targeted therapy for use as first line therapy for patients with metastatic renal cell carcinoma.
15966289|NCT03140163|Radiation|ULD-CT|Siemens Healthcare SOMATOM FORCE Ultra Low Dose chest CT
15966290|NCT03140163|Radiation|CXR|Conventional chest radiograph
15966291|NCT03140150|Device|Follow-up by Carelink express|Followed by the cardiologist exclusively using Carelink Express during the study period: a single visit 1 to 3 months after implantation, then followed by the cardiologist and interrogation of the stimulator by Carelink Express
15966292|NCT03140150|Other|Follow-up according to the usual recommendations|According to follow-up recommendations for pacemakers, a visit is planned every 6 months if the patient is dependent on the stimulator (either visits to M6, M12, M18 and M24) or annually if the patient is not dependent on the stimulator (visits to M12 and M24).
15966293|NCT03140137|Drug|Checkpoint inhibitor therapy|Treatment by ipilimumab, nivolumab or pembrolizumab for advanced cancer in clinical practice
15966294|NCT03140124|Behavioral|Exercise|Each participant will be provided with an ActiveLife Trainer to use during visit 2 or 3. The ActiveLife Trainer is a stationary pedaling machine that one can use while seated. It was designed to be used while working and makes very little noise. It is a safe, low-impact physical activity machine with adjustable resistance. The machine communicates via Bluetooth with the Wahoo Fitness app which records activity metrics such as distance cycled. Participants will be provided with a tablet on which the Wahoo Fitness app will track their exercise during the session. The ActiveLife Trainer has been used in numerous research studies (Carr et al., 2014; Botter et al., 2013; Burford et al., 2013; Carr et al., 2013).
15966295|NCT03140124|Behavioral|Worry Stone|For the worry stone condition, both the participants will rub a stone for the duration of the session. Each participant will be provided with a worry stone to rub during visit 2 or 3. These are small sooth stones that fit in the palm of one's hand.
15966296|NCT03140111|Device|LAMELLEYE|Liposomal multi-dose preservative-free sterile suspension which contains soy lecithin phospholipids, sphingomyelin and cholesterol, suspended in saline.
15966297|NCT03140111|Device|OPTIVE FUSION|Multi-dose sterile solution which contains sodium hyaluronate 0.1%, sodium carboxymethylcellulose 0.5%, glycerine 0.9%, erythritol, boric acid, sodium citrate dihydrate, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, and is preserved with PURITE® 0.01% which breaks down into natural tear components on the eye.
15966298|NCT03140098|Device|cardiac surgery requiring a collagen membrane COVA™+|At the end of the cardiac surgery, the collagen membrane is implanted on the dissection area in order to prevent the formation of postoperative adhesions.
15966301|NCT03140085|Other|Sterile bacteriology media|Sterile bacteriology media, with identical color as bacteriophage preparation
15966302|NCT03140072|Drug|AZD9898|In Parts 1 and 2 of the study, each subject/patient will receive a single dose (one dose level) of AZD9898, under fasted conditions. Starting dose in part 1 (SAD in healthy subjects) is 3 mg, subsequent doses will be selected based on emerging data. In Part 3 of the study, each subject will receive one dose level of AZD9898, once daily, under fasted or fed conditions. Subjects participating in Part 3B (food effect cohort) will receive an additional administration of the same dose, on the last day to investigate the effects of food.
15966303|NCT03140072|Drug|Matching Placebo|In Parts 1 and 2 of the study, each subject/patient will receive a single dose (one dose level) of matching placebo, under fasted conditions. In Part 3 of the study, each subject will receive one dose level of matching placebo, once daily, under fasted or fed conditions. Subjects participating in Part 3B (food effect cohort) will receive an additional administration of the same dose, on the last day to investigate the effects of food.
15966304|NCT03140059|Procedure|Open flap debridement|Open flap debridement will be performed to decontaminate root surface
15966305|NCT03140059|Procedure|Repeated application of aPDT|Repeated application of photodynamic therapy (aPDT) at 0, 1, 2, 7 and 14 days post-operatively.
15966306|NCT03140046|Procedure|photorefractive keratectomy (PRK)|"The cornea will be ablated while the patient fixating on target light under constant eye-tracking control. The ablations will be made using the ALLEGRETTO X 500WAVE excimer laser (WaveLight Laser Technologie AG)."
15966307|NCT03140033|Drug|Misoprostol Oral Tablet|at cord clamping the patient will recieve 400 micrograms of misoprostol sublingually
15966308|NCT03140033|Drug|Ranitidine Oral Tablet|at cord clamping the patient will recieve ranitidine sublingually
15966309|NCT03140020|Procedure|Clipping|During the microsurgical operation a titan clip will be placed round the aneurysm neck to exclude the aneurysm from the bloodflow and prevent fatal subarachnoidal hemorrhage.
15966310|NCT03140020|Procedure|Coiling|Using a catheter technique the aneurysm dome will be filled up with coils to prevent subarachnoidal hemorrhage.
15966311|NCT03140007|Device|single operator cholangioscopy|If patient is randomized to the Study arm, then the procedure will consist of the following in order: Cannulation and sphincterotomy per standard of practice. POCS with recording of POCS-based impression of malignancy (yes/no/indeterminate). POCS will be performed using the Spy DS system. POCS-guided biopsies will be collected, consisting of 6 macroscopically visible biopsies. The POCS-guided biopsy forceps will be the SpyBite forceps.
15966312|NCT03140007|Device|ERCP guided brushing and biopsy|• If patients are randomized to the Control arm, then they will undergo an ERCP. ERCP-based impression of malignancy (yes/no/indeterminate) will be recorded. ERCP-guided brushing and ERCP-guided biopsy will be performed.
15966313|NCT03139994|Other|Diagnostic|OBSERVATIONAL, DIAGNOSTIC PROCEDURES. Young adults with no signs or symptoms of TMD will be assessed. The chewing function, condylar path angles and lateral guidance angles will be recorded. Maximum comfortable and unassisted jaw opening, hemispheric dominance and hemimandibular retrognathia will be considered as secondary pre-specified outcomes. Three-Four years later, both TMJs of each participant presenting signs and/or symptoms will be evaluated according to DC/TMD. Same recordings as baseline will be carried out.
15966314|NCT03139981|Drug|ASN002|Daily dose of ASN002 for 28 days
15966315|NCT03139981|Drug|Placebo Oral Tablet|Placebo for ASN002 for 28 days
15966316|NCT03139968|Device|(sham) radiation absorbing drape (RADPAD®)|
15966317|NCT03139955|Device|Bodytrak|Bodytrak is a wireless earpiece which can monitor the user's vital signs such as tympanic (ear) temperature and heart rate. The earpiece is non-invasive and should fit comfortably within the right ear, similar to an earphone with an over-the-ear hook. Bodytrak is currently in a prototype stage. For further information please visit http://www.bodytrak.co
15966318|NCT03139942|Device|Optical spectral reflectance and autofluorescence imaging|When a suitable area of tissue is identified by the clinician during a patient's colonoscopy (e.g., a polyp), the imaging probe is inserted into the colonoscope so that it can view the tissue. Optical spectral reflectance and autofluorescence imaging is then performed to collect white light reflected by, and fluorescent light emitted from, the tissue. This is then analysed by hardware and software components in the external analysis unit.
15966319|NCT03139929|Diagnostic Test|MSFP|MSFPhold and MSFParm
15966323|NCT03139890|Other|High-fat (HF-LC-LP) milkshake|During this experimental day, men will receive a high-fat milkshake
15966324|NCT03139890|Other|High-carbohydrate (LF-HC-LP) milkshake|During this experimental day, men will receive a high-carbohydrate milkshake
15966325|NCT03139890|Other|High-protein (LF-LC-HP) milkshake|During this experimental day, men will receive a high-protein milkshake
15966326|NCT03139864|Procedure|controlled physical activity|Comparison between infants with type 1 diabetes and infants without type 1 diabetes during exercise :
15966327|NCT03139851|Drug|Cyclophosphamide 50mg|One tablet per day. Cyclophosphamide will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
15966328|NCT03139851|Drug|Pembrolizumab 100 MG in 4 ML Injection|IV infusion every 3 weeks. Pembrolizumab will continue to be administered as long as patient experiences clinical benefit in the opinion of the investigator or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
15966329|NCT03139838|Behavioral|EHR-Based Intervention A|Intervention A will be a prompt for clinicians to document an estimated prognosis for patients at 6 months, and an assessment of predicted functional outcome if expected to survive.
15966330|NCT03139838|Behavioral|EHR-Based Intervention B|Intervention B will entail a prompt for clinicians to provide a reason for not offering patients and their families the alternative of care focused entirely on comfort despite recommendations from critical care professional societies to do so for patients at high risk for death or severely impaired functional recovery.
15966331|NCT03139825|Other|Exploring the feasibility of learning during cognitive tasks (EEG-NIRS)|Exploring the feasibility of the study in its aspects of recruitment and tolerability of tasks and acquisition of electrical and hemodynamic data that can be used during cognitive tasks
15966332|NCT03139812|Drug|Daily irrigation|Daily morning irrigation of the eye with sterile, borate-buffered, saline solution (Unisol 4) and gentle nudging of the lens to promote solution flow beneath the lens
15966333|NCT03139812|Device|30-day SiH CW|30-day continuous wear of silicone hydrogel contact lenses
15966334|NCT03139799|Behavioral|Experimental - Puzzle Video Game Intervention|The psychological intervention consists of two custom-made versions of popular commercial casual puzzle video games (Flow Free, Big Duck Games LCC; Bejeweled, PopCap Games). The puzzle games are delivered on tablet-computers computer (12.9-inch tablet computer iPad Pro, Apple Inc., Cupertino, CA, USA).
15966335|NCT03139799|Behavioral|Control - Tablet Newspaper Reading Intervention|The control intervention uses a newspaper/ magazine reading task that will be delivered to participants using the same device (iPad Pro) as in the experimental intervention. The newspaper/ magazine reading task will be running on the built-in Apple Newsstand application. Participants will be offered subscriptions for two newspapers and/or magazines that they are instructed to read following the same regime as in the experimental condition.
15966336|NCT03139786|Other|Study the natural history of bicuspid|Study the natural history of bicuspid
15966337|NCT03139773|Dietary Supplement|Control Breakfast Beverage|Each participant consumes the breakfast beverage every morning before 10:00 am for 14 days.
15966338|NCT03139773|Dietary Supplement|Omega-3 Breakfast Beverage|Each participant consumes the breakfast beverage every morning before 10:00 am for 14 days.
15966339|NCT03139760|Behavioral|POWERSforID|Feasibility and outcomes associated with use of the POWERSforID system and coaching phone calls over the course of 24 weeks
15966340|NCT03139747|Drug|Lenvatinib|Lenvatinib is an anti-cancer drug for the treatment of certain kinds of thyroid cancer, and potentially for other cancers as well. It was developed by Eisai Co. and acts as a multiple kinase inhibitor against the VEGFR1, VEGFR2 and VEGFR3 kinases.
15966341|NCT03139747|Drug|Everolimus|It is currently used as an immunosuppressant to prevent rejection of organ transplants and in the treatment of renal cell cancer and other tumours. Much research has also been conducted on everolimus and other mTOR inhibitors as targeted therapy for use in a number of cancers.
15966342|NCT03139734|Device|Sacral Neuromodulation|S3 nerve root (sometimes S4) is stimulated with low electrical current via an electrode placed through a sacral foramen. This electrode is connected to a stimulator resembling a cardiac pacemaker.
15966344|NCT03139708|Drug|Alphagan|"Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one.
~Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one."
15966345|NCT03139708|Drug|Phenylephrine|"Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one.
~Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one.
~Arm: Active Comparator: Tropicamide and Phenylephrine only Tropicamide and Phenylephrine only arm is given one drop of each times one."
15966346|NCT03139708|Drug|Tropicamide|"Arm: Experimental: Alphagan plus Alphagan plus group is one drop Brimonidine then, Tropicamide and Phenylephrine ophthalmic one drop,times one.
~Arm: Experimental: Tropicamide and Phenylephrine plus Tropicamide and Phenylephrine plus intervention is one drop of each then Brimonidine one drop, times one.
~Arm: Active Comparator: Tropicamide and Phenylephrine only Tropicamide and Phenylephrine only arm is given one drop of each times one."
15966347|NCT03139695|Diagnostic Test|Ultrasound|High resolution Ultrasound of the Diaphragm and Intercostal muscles
15966348|NCT03139669|Device|Viba collection brush|HPV home collection kit using the viba collection brush to collect cervical cells for HPV DNA testing.
15966349|NCT03139656|Behavioral|Values Clarification|This intervention will incorporate elements from several widely established self-regulatory strategies aimed at enhancing the motivational aspects of goal pursuit, including mental contrasting (Oettingen, 2000), self-reflection (Koestner et al., 2002), self-affirmation (Schmeichel and Vohs, 2009), and the values clarification components of Acceptance and Commitment Therapy (ACT; Hayes, Strosahl, & Wilson, 1999). Participants will be prompted to enter their selected health goal and will then be instructed to identify personal values that might be practiced in pursuit of this goal. Participants will write about these values for several minutes, after which they will be instructed to select a short phrase or image that conjures up for them the reasons they choose to engage in their goal. Participants will be asked to type the phrase into a textbox and will have the option of receiving a confidential print-out of their chosen phrase at the end of the study visit.
15966350|NCT03139656|Behavioral|Planning|"Participants in this condition will be guided to create detailed implementation intentions, or if-then planning statements (Gollwitzer & Sheeran, 2006), specifying when, how, and where they will engage in their selected health goal. Participants will be provided with a detailed rationale adapted from earlier research on implementation intentions (e.g., Webb et al., 2010). Participants will be guided to generate a plan indicating when, where, and how they will enact their goal-based behavior over the next week. They will also be prompted to identify 3 obstacles they are likely to encounter during the pursuit of each goal, and to specify in an if-then format what specific actions they will take to overcome each obstacle (following the procedures and sample if-then responses of Koestner et al., 2002). They will be asked to rehearse each if-then statement to themselves before the end of the visit."
15966351|NCT03139656|Behavioral|Combined|"Participants in this condition will complete abbreviated versions of both the values clarification and planning procedures, as detailed above. Participants will be prompted to identify 2 obstacles (as opposed to 3) they might encounter during the pursuit of each goal. For each of the obstacles they identify with respect to each of their target goals, they will be prompted to form an additional implementation intention in the form: When [I encounter the specified obstacle], I will do [X] and remember [values-based statement or image identified during values clarification exercise]. They will be asked to rehearse these if-then statements to themselves before the end of the visit."
15966379|NCT03139487|Drug|Dalteparin|200 IU/kg q24 hours for 4 weeks followed by 150 IU/kg q24 hours for 20 weeks
15966352|NCT03139643|Other|Cognitive Dissonance|After reading the materials about their chosen behavior, participants will be asked write an essay about their behavior of choice (studying/exercising). For this essay they will be asked to imagine that they have reached their ideal level of academic achievement/fitness, describe what this would look and feel like, and reflect on how this would impact how they view themselves, their relationships, and their day to day life.
15966353|NCT03139643|Other|Action Planning|After reading the materials about their chosen behavior, participants will be asked to make a detailed plan for the following two weeks based on the following items taken from a study by Sniehotta and colleagues (2004): 1) when to complete studying/exercise, 2) where to complete studying/exercise, 3) how to complete studying/exercise (e.g., what types of exercise- cardio, class, etc. or what types of studying activities- reading, taking notes, creating outlines, etc.), and 4) how often to complete studying/exercise. Participants will be given a calendar as an aid to planning their behavior.
15966354|NCT03139643|Other|Reflection (Control Condition)|After reading the materials about their chosen behavior, participants will be asked to summarize and reflect on what they read.
15966355|NCT03139617|Procedure|Fascia Iliaca Compartment Block (FICB)|"The FICB was done in the OT with standard monitoring with emergency airway intervention and resuscitation drug prepared before performing intended block. Patient was put in supine position, using aseptic technique, chlorhexidine solution and draped with sterile medical towel. Lignocaine 2% for local anaesthetic infiltration at punctured site.A blunted needle (Plexufix® 24G x 2, B Braun Melsungen AG 34209 Germany).A line was drawn from pubic tubercle to anterior superior iliac spine, the punctured point is 2-3cm distal to the point where medial 2/3rd and lateral 1/3rd of the line meet. Loss of resistance 2 times indicated the punctured of fascia lata and iliaca.A total volume of Ropivacaine 0.375% per body weight was given with repeated aspiration."
15966356|NCT03139617|Procedure|3 in 1 femoral block (FNB)|"The FNB was done in the OT with standard monitoring with emergency airway intervention and resuscitation drug prepared before performing intended block.Patient was put in supine position, using aseptic technique, chlorhexidine solution and draped with sterile medical towel.Lignocaine 2% for local anaesthetic infiltration at punctured site.An insulated stimulating needle (Stimuplex® D Plus 22g x 2, B Braun Melsungen AG 34209 Melsungen Germany). Ultrasound was used to locate the femoral vessel and nerve and by using 'in plane' technique, the skin was punctured with the insulated needle and advance in transverse plane at around 30 angle to the skin. Local anaesthetic solution as per ideal body weight given after negative aspiration of blood ."
15966357|NCT03139604|Drug|Itacitinib|Itacitinib at the protocol-defined dose administered orally once daily (QD) plus corticosteroids.
15966358|NCT03139604|Drug|Placebo|Matching placebo tablets administered orally once daily (QD) plus corticosteroids.
15966359|NCT03139604|Drug|Prednisone|Oral prednisone may be used to begin standard corticosteroid background treatment at the investigator's discretion, at a dose equivalent to methylprednisolone 2 mg/kg per day.
15966360|NCT03139604|Drug|Methylprednisolone|Methylprednisolone 2 mg/kg IV daily (or prednisone equivalent) or at a dose appropriate for the severity of disease as background treatment.
15966361|NCT03139591|Drug|lidocaine inhalation; intravenous dexamethasone|1.5 mg/kg body weight (BW) of 2% lidocaine inhalation, diluted with 2-3 ml of normal saline until the total volume was 6 ml, and intravenous normal saline injection; Intravenous dexamethasone group: normal saline inhalation and 10 mg of intravenous dexamethasone.
15966362|NCT03139578|Device|Test 8.5BC|senofilcon A contact lenses with 8.5 base curve
15966363|NCT03139578|Device|Test 9.0BC|senofilcon A contact lenses with 9.0 base curve
15966364|NCT03139578|Device|Control 8.5BC|narafilcon A contact lenses with 8.5 base curve
15966365|NCT03139578|Device|Control 9.0BC|narafilcon A contact lenses with 9.0 base curve
15966366|NCT03139565|Biological|Fluzone High-dose Influenza Vaccine|This treatment consists of 60 microgram of each influenza antigen provided as a single injection, which will be injected in the deltoid muscle of the non-dominant arm.
15966367|NCT03139565|Biological|Standard 2016-2017 Flu vaccine|The intramuscular preparation of the vaccine used for the control group will be the Standard influenza vaccine made available by public health. The intramuscular dose (standard 0.5 mL) will contain 15 microgram antigen from each strain and delivered in the deltoid muscle by trained personnel.
15966368|NCT03139552|Other|Apple Crisp|Subjects tasted the three recipes (full sugar recipe, reduced sugar recipe, and reduced sugar plus spice recipe) of apple crisp in a randomized sequence schedule. Tastings for each test item (apple crisp, tea and oatmeal) were done during separate weeks. Subjects tasted each recipe of an item at one sitting (ie: subject completed apple crisp tastings during one seating during first week, oatmeal tastings during one seating the next week and tea tastings during one seating the next and final week).
15966369|NCT03139552|Other|Tea|Subjects tasted the three recipes (full sugar recipe, reduced sugar recipe, and reduced sugar plus spice recipe) of tea in a randomized sequence schedule. Tastings for each test item (apple crisp, tea and oatmeal) were done during separate weeks. Subjects tasted each recipe of an item at one sitting (ie: subject completed apple crisp tastings during one seating during first week, oatmeal tastings during one seating the next week and tea tastings during one seating the next and final week).
15966370|NCT03139552|Other|Oatmeal|Subjects tasted the three recipes (full sugar recipe, reduced sugar recipe, and reduced sugar plus spice recipe of oatmeal in a randomized sequence schedule. Tastings for each test item (apple crisp, tea and oatmeal) were done during separate weeks. Subjects tasted each recipe of an item at one sitting (ie: subject completed apple crisp tastings during one seating during first week, oatmeal tastings during one seating the next week and tea tastings during one seating the next and final week).
15966371|NCT03139539|Device|Ioban|
15966372|NCT03139526|Other|observational study so no intervention|observational study, so no intervention
15966373|NCT03139513|Drug|Cobimetinib|Participants will receive cobimetinib as per local guidelines and/or routine clinical practice.
15966374|NCT03139513|Drug|Vemurafenib|Participants will receive vemurafenib as per local guidelines and/or routine clinical practice.
15966375|NCT03139500|Drug|JNJ-61803534|Participants will receive JNJ-61803534 tablets orally.
15966376|NCT03139500|Drug|Placebo|Participants will receive matching placebo.
15966377|NCT03139500|Drug|Midazolam|Participants will receive single oral dose of midazolam.
15966378|NCT03139487|Drug|Rivaroxaban|15 mg q12 hours for 3 weeks followed by 20mg q24 hours for 21 weeks
15966380|NCT03139487|Drug|apixaban|10 mg q12 hours for 7days followed by 5mg q12 hours for 21 weeks
15966381|NCT03139474|Drug|Gonadotropin-Releasing Hormone Analogue|Triptorelin at a dose 1 mg per day from the midluteal phase of the cycle preceding the treatment cycle to day 2 of the cycle then 0.5 milligram of triptorelin will be used during the period of stimulation.
15966382|NCT03139474|Drug|Gonadotropin releasing hormone antagonist|antagonist group :Multiple dose gonadotrophin-releasing hormone antagonist regimen will be used for ovarian stimulation 0.25 microgram per day cetrorelix will be administered from the 6th day of ovarian stimulation or from the presence of follicle 14 millimeter diameter .We will give them gonadotrophin for 5 days , Triggering by Human Chorionic Gonadotrophin will be administered for each group when size of follicle reach > 17 millimeter .Oocytes will retrieved by transvaginal ultrasound , 34-36 hours after Human Chorionic Gonadotrophin administration .
15966383|NCT03139461|Other|PT-REFER Capacity-building Toolkit|"Written guidelines for building partnerships with physical therapists. Information includes information on who to contact, how to contact them, and how to present information about the program (e.g., evidence base, program structure)
~Support from Change Agent
~Technical Assistance Calls"
15966384|NCT03139448|Device|Oxygen via nasal cannula|Oxygen will be supplied to the patient via nasal cannula according to the routine standard of care practice at Vanderbilt University Medical Center.
15966385|NCT03139448|Device|Oxygen via SuperNO2VA nasal mask|The anesthesia provider will attach the SuperNO2VA's (Revolutionary Medical, Inc) circuit port to the anesthesia machine, turn the oxygen flow rate to 10L/min, and set the APL valve to 10 cm H2O.
15966386|NCT03139435|Procedure|Biopsy|Undergo skin biopsy
15966387|NCT03139435|Other|Questionnaire Administration|Ancillary studies
15966388|NCT03139435|Diagnostic Test|Ultrasound Tomography|Undergo peripheral nerve ultrasound
15966389|NCT03139422|Drug|Tranexamic Acid 500 MG|oral tablets
15966390|NCT03139422|Drug|Calcium Dobesilate|oral tablets
15966391|NCT03139409|Procedure|adhesive bond with chlorhexidine|Peak® Universal Bond (ultradent, 505 West 10200 South, South Jordan, UT 84095،USA ) light-Cured Adhesive with Chlorhexidine (0.2%), 7.5% filler, phosphate and containing hydroxyethyl methacrylate with ethyl alcohol as the carrier. its viscosity has been optimized for minimal film thickness (2μm) and superior strength. using self etch adhesive with chlorexidine as one step in the bonding component may give chance to proper penetration of resin tags, decrease the micro-organisms due to the antibacterial effect of chlorexidine (Bin-Shuwaish, 2016) and also the addition of chlorexidine in bonding system may be an excellent tool to increase the stability of collagen fibrils within the hybrid layer against host-derived metaloproteinases (MMP) without the need for additional steps for the bonding protocol (Stanislawczuk, et al., 2009), which results in better durability and good restorations with decreasing the incidence of recurrent caries
15966392|NCT03139409|Other|Time variable|Diagnosis and follow up will be immediate , 6 months later and 1 year
15966393|NCT03139396|Procedure|tub shaped inlay bridge design|inlay retained bridge with tub shaped retainer on both abutments
15966394|NCT03139383|Other|dextrose solution|The patients received 5%D/N/2 during surgery
15966395|NCT03139383|Other|saline solution|The patients received NSS during surgery
15966396|NCT03139370|Drug|KITE-718|A single infusion of autologous genetically modified MAGE-A3/A6 T-cell receptor (TCR) transduced autologous T cells (KITE-718).
15966397|NCT03139370|Drug|Cyclophosphamide|Administered intravenously
15966398|NCT03139370|Drug|Fludarabine|Administered intravenously
15966399|NCT03139370|Device|MAGE - A3/A6 Screening Test|A screening test for MAGE-A3/A6+ tumors
15966400|NCT03139357|Other|GAD7, SF12, medical utilization, helpfulness questionnaire|The questionnaires are administered to track stress level and medical utilization over a 2 year period.
15966401|NCT03139344|Other|Low-frequency Exercise|The quadriceps/hamstrings will perform exercise via the application of 1 Hz electrical stimulation.
15966402|NCT03139344|Other|High-frequency Exercise|The quadriceps/hamstrings will perform exercise via the application of 3 Hz electrical stimulation.
15966403|NCT03139331|Drug|Pazopanib|Pazopanib will be administered orally as a tablet according to an assigned dose level per protocol. A cycle will be defined as 21 days. Drug dosing for the tablet formulation will be determined using a study-specific nomogram.
15966404|NCT03139331|Drug|Irinotecan|"Patients will be given irinotecan at a dose of 25 mg/m2/dose IV on days 1-5 of a 21-day cycle during Cycle 1. In subsequent cycles, irinotecan may be given intravenously at a dose of 25 to 37.5 mg/m2/dose or orally at a dose of 45 to 67.5 mg/m2/dose on days 1-5 of a 21-day cycle.
~Note that some patients enrolled on an earlier protocol version received 50 mg/m2/dose IV on days 1-5 of the first 21-day cycle and then either 50 mg/m2/dose IV or 90 mg/m2/dose orally for subsequent 21-day cycles. This higher dose level is no longer being given to newly enrolled subjects."
15966405|NCT03139331|Drug|Temozolomide|Temozolomide will be given at a dose of 100 mg/m2/dose orally on days 1-5 of each 21-day cycle.
15966406|NCT03139318|Radiation|GRID radiotherapy|Patients will be treated with GRID radiotherapy
15966407|NCT03139305|Drug|Glucagon|Low dose intravenous infusion for 72 hours at 12.5 ng/kg/min
15966408|NCT03139305|Drug|Glucagon|High dose intravenous infusion for 72 hours at 25 ng/kg/min
15966409|NCT03139305|Drug|Placebo|Intravenous infusion of saline for 72 hours
15966410|NCT03139292|Device|ProSeal Laryngeal Mask Airway|ProSeal Laryngeal Mask Airway was used as the supraglottic device
15966411|NCT03139292|Device|AmbuAuraGain Laryngeal Mask Airway|AmbuAuraGain Laryngeal Mask Airway was used as the supraglottic device
15966412|NCT03139279|Drug|Dexmedetomidine|Dexmedetomidine 0.3 ug/kg intravenous bolus
15966413|NCT03139279|Other|Saline placebo|Intravenous saline/placebo
15966414|NCT03139279|Drug|Propofol|Propofol titrated intravenous boluses
15966415|NCT03139266|Behavioral|UPLIFT|Participation in the sessions involves skills practice, discussions, and group exercises based on the sessions' main topics. CBT-related topics include thought monitoring, identifying cognitive distortions, self-esteem, problem identification, goal setting, and identifying supports. Relaxation exercises, including a body scan (i.e., a mindfulness exercise) and progressive muscle relaxation, are also used for coping and to facilitate awareness of the body. Mindfulness activities include attention to skin, sights, and sounds and other meditations. Participants will practice their skills between sessions through homework assignments including monitoring and changing thoughts, and practicing relaxation exercises, meditation exercises, and mindfulness.
15966416|NCT03139266|Behavioral|Treatment as usual|The control group will receive the recommendation to consider maintaining mental health services
15966417|NCT03139253|Drug|amoxicillin|amoxicillin 1000 mg bid. for 14 days
15966418|NCT03139253|Drug|clarithromycin|clarithromycin 500 mg bid. for 14 days.
15966419|NCT03139253|Drug|tinidazole|tinidazole 500 mg bid. for 14 days.
15966420|NCT03139253|Drug|levofloxacin|levofloxacin 500 mg qd. for 14 days.
15966421|NCT03139253|Drug|furazolidone|furazolidone 100 mg bid. for 14 days.
15966422|NCT03139253|Drug|tetracycline|tetracycline 750 mg bid. for 14 days.
15966423|NCT03139253|Drug|Ilaprazole|Ilaprazole 5 mg bid. for 14 days.
15966424|NCT03139240|Drug|Oxycodone 10mg oral|Oxycodone 10mg oral given for pain control in addition to standard of care medications in women undergoing medical abortion
15966425|NCT03139240|Other|Placebo|Placebo given in addition to standard of care medications in women undergoing medical abortion
15966426|NCT03139227|Procedure|Bio specimen Collection|Patients undergo collection of blood and urine
15966427|NCT03139227|Dietary Supplement|Dietary Intervention|Consume celery-banana bread
15966428|NCT03139227|Other|Laboratory Biomarker Analysis|Correlative studies
15966429|NCT03139214|Behavioral|Parenting Intervention|
15966430|NCT03139201|Device|OxyAqua|OxyAqua (olifilcon D) silicone hydrogel soft contact lens
15966431|NCT03139201|Device|Si-Hy|Si-Hy (oliflcon B) silicone hydrogel soft contact lens
15966432|NCT03139175|Device|balance assessment with Biodex balance system|All subjects of three groups will be assessed with the evaluation device( balance system).
15966433|NCT03139162|Other|Swiss RAI-HC assessment|RAI-HC assessments done by trained nurses in clinical routine
15966434|NCT03139149|Procedure|Adhesiolysis|"Method of video laparoscopic operation:
~Open access in the left upper quadrant of the anterior abdominal wall,
~Installation of trocars, depending on the prevalence of the adhesion process
~Assessment of the peritoneal adhesion index
~Detection of the asleep gut
~Detection of obstacle area
~Removing the obstacle without trying to completely eliminate the adhesion process in the abdominal cavity
~If there is no possibility to eliminate the cause of intestinal obstruction laparoscopically laparotomy is performed."
15966435|NCT03139149|Radiation|X-ray diagnostics|X-ray of the thoracic (1) and abdomen (2-5 times) with water soluble contrast.
15966436|NCT03139149|Radiation|Computer tomography|Computer tomography of abdomen with iv contrast
15966437|NCT03139149|Procedure|Ultrasound|Ultrasound of the abdomen (2 times)
15966438|NCT03139149|Other|General and biochemical blood test|General blood test and biochemical blood test 2 times a day
15966439|NCT03139136|Drug|MBS2320|As described in the arm descriptions
15966440|NCT03139136|Drug|Placebo|As described in the arm descriptions
15966441|NCT03139123|Other|Hemodynamic monitoring during passive leg raising|Measurement of hypotensive episodes related to preload dependance.
15966442|NCT03139110|Behavioral|Presence of a mediator in the emergency departments|"The mediator tasks are :
~Be available to patients who can solicit him and respond to their requests for information, in particular on the organization of the emergency departments and on waiting times
~Have a proactive attitude towards patients showing nervousness signs
~Report patients expressing the will to leave the emergency departments before medical care
~Manage conflicts between patients / accompanying persons and emergency staff and also between patients."
15966443|NCT03139097|Diagnostic Test|Quantra System|Diagnostic device to monitor coagulation properties of a whole blood sample at the point-of-care.
15966444|NCT03139058|Other|Evaluation of the hepatic fibrosis|Evaluation of the hepatic fibrosis stage by a hepatological assessment (Clinical, biological and imaging)
15966445|NCT03139045|Biological|Venous puncture in elderly patients|Venous puncture in elderly patients
15966446|NCT03139032|Drug|APD334|APD334 active treatment for 12 weeks.
15966447|NCT03139019|Behavioral|Process incentives|Participants will receive cash based incentives for achieving process based measures (class attendance).
15966448|NCT03139019|Behavioral|Outcome incentives|Participants will receive cash based incentives for outcome based measures (weight loss).
15966449|NCT03139019|Behavioral|Process and Outcome incentives|Participants will receive cash based incentives for both achieving process based measures (class attendance) and outcome based measures (weight loss).
15966450|NCT03139006|Device|Dual-layer spectral detector CT|A dual energy CT approach
15966451|NCT03138993|Behavioral|Patient decision aid|Web-based patient decision aid plus a paper workbook.
15966452|NCT03138993|Behavioral|General sleep education|Web-based information about sleep plus a paper workbook
15966453|NCT03138980|Behavioral|BodiMojo Buddy for IBS|"Mobile application focusing on emotional coping skills for teens and young adults with IBS. Components of the module include: mood recorder and mood cloud, with supportive feedback given based on mood choice; health behavior change support messages informed by mindfulness and self-compassion; quizzes with tailored feedback; library of meditations; an interactive coping skills advice section; and a link to an optional social support feature."
15966454|NCT03138967|Drug|Rocuronium|Experimental: Sugammadex Participants to have cystoscopy with bladder tumor resection. Rocuronium used to induce the neuromuscular blockade and given in a rapid sequence for endotracheal intubation at a dose of 0.45 mg/kg of Ideal Body Weight. If maintenance is needed for continued relaxation then a dose of 0.15 mg/kg of Ideal Body Weight repeated as necessary.
15966455|NCT03138967|Drug|Sugammadex|Sugammadex administered as a single bolus, intravenous injection. The amount used is based on the patient's weight. A dose of 4 mg/kg used if recovery has reached at least 1-2 post-tetanic counts (PTC) following Rocuronium induced blockade.
15966456|NCT03138967|Drug|Neostigmine|70 mcg/kg by vein to reverse the muscle relaxation.
15966457|NCT03138967|Drug|Glycopyrrolate|14 mcg/kg by vein to reverse the muscle relaxation.
15966458|NCT03138928|Device|XEN45 gel stent implantation in glaucoma surgery|The XEN gel stent (Allergan, Dublin, Ireland) is a recently developed, permanent, ab interno collagen implant that reduces IOP by draining aqueous fluid from the anterior chamber into the subconjunctival space
15966459|NCT03138915|Procedure|HVPG measurement|HVPG obtained by means of catheterization of a hepatic vein with a balloon catheter.
15966460|NCT03138915|Procedure|CTA|Radiomic features were extracted from CTA images.
15966461|NCT03138902|Dietary Supplement|TRUTOL Glucose Tolerance Beverage|A caffeine-free, non-carbonated, glucose tolerance beverage
15966471|NCT03138876|Device|EEG Cap|Patient will be fitted with an EEG cap by the on-call neurology resident to assess for NCSE.
15966472|NCT03138876|Drug|Anti-seizure medication|Patients may be treated for NCSE or seizures based on EEG cap findings, if the findings are clear to an attending EEG reviewer. If the subject is treated with anti-seizure medication, the primary care provider will choose which medication will be given.
15966473|NCT03138876|Procedure|Standard EEG|An electroencephalogram (EEG) is a test used to find problems related to electrical activity of the brain. An EEG tracks and records brain wave patterns. Small metal discs with thin wires (electrodes) are placed on the scalp, and then send signals to a computer to record the results.
15966474|NCT03138863|Device|BALT GoldbBAL2 Detachable Balloon|Latex balloon, with radio-opaque inclusion
15966475|NCT03138863|Device|Catheter System|100 cm tapered micro-catheter
15966476|NCT03138850|Device|Olympus standard bite block|Intravenous sedative upper gastrointestinal endoscopy performed under standard bite block (MB142 reusable bite block, Olympus) and nasal cannula with oxygen 5L/min
15966477|NCT03138850|Device|YX mandibular advancement bite block|Intravenous sedative upper gastrointestinal endoscopy performed under mandibular advancement bite block for endoscopy (Yong Xu breathing mouth piece, Yong Xu) and oxygen connected to mouth piece 5L/min
15966478|NCT03138850|Device|Optiflow High flow nasal cannula|Intravenous sedative upper gastrointestinal endoscopy performed under standard bite block (MB142 reusable bite block, Olympus) and high flow nasal cannula
15966479|NCT03138837|Diagnostic Test|Magnetic resonance imaging|Diffusion Weighted Magnetic resonance imaging
15966480|NCT03138824|Procedure|SPIES assisted TURBT|SPIES assisted TURBT of NMIBC
15966481|NCT03138824|Procedure|WLI assisted TURBT|White Light Imaging (WLI) assisted TURBT for treatment of NMIBC
15966482|NCT03138811|Drug|CSJ117|inhaled once daily dose
15966483|NCT03138811|Drug|Placebo Comparator|inhaled once daily dose
15966484|NCT03138798|Device|Laboraide TM dental support device|Patients will give consent in the first stage of labor. Subsequently a randomization will be performed using sealed envelopes opened at the time of pushing in the second stage of labor. Women assigned to Group A will received a sealed Laboraide TM package. Duration of the second stage and time spent pushing will be recorded. Obstetric management will not be altered by group assignment. Following delivery, patients assigned to Group A will complete a patient satisfaction survey.
15966485|NCT03138785|Drug|topical voriconazole / levofloxacin systemic itraconazole|starting topical voriconazole every hour tapering after 4 days , levofloxacin every 6 hours, Itraconazole 100mg /BD for 2 weeks
15966486|NCT03138785|Radiation|CXL|30 min Riboflavin prescription to the cornea followed by 30 min UV-A radiation at 3mW/cm2 associated with Riboflavin administration
15966487|NCT03138772|Other|This is an observational study, no intervention used.|No intervention is being used in this study.
15966488|NCT03138759|Drug|Pexidartinib|Orally, on Day 2
15966489|NCT03138759|Drug|Probenecid|Orally, on Day 2
15966490|NCT03138746|Procedure|HBO|"Compression in a hyperbaric chamber in air to 2 atmospheres absolute, then donning a hood supplying high flow oxygen for 90-minutes followed by a linear decompression back to 1 atmosphere over 30 minutes"
15966491|NCT03138746|Procedure|Hyperbaric air|"Compression in a hyperbaric chamber in air to 2 atmospheres absolute, then donning a hood supplying high flow air for 90-minutes followed by a linear decompression back to 1 atmosphere over 30 minutes"
15966492|NCT03138733|Drug|Ceftobiprole medocaril|Ceftobiprole medocaril 500 mg as 2 h infusion
15966493|NCT03138733|Drug|Daptomycin|Daptomycin 6 mg/kg as 0.5 h infusion, with or without Aztreonam
15966494|NCT03138720|Drug|Paclitaxel Protein Bound (Abraxane)|Participants will be treated with the regimen prior to having surgery. Participants will complete 3 cycles (cycle is 21 days) and then will be evaluated for CA19-9 normalization. If CA19-9 is normalized, then participant will be scheduled for surgery and moved to standard of care. If CA19-9 is not normalized then participants will complete another 3 cycles.
15966495|NCT03138707|Other|patients who die|
15966496|NCT03138694|Other|BHCG monitoring|Participants in the study will be invited to our outpatient clinic for BHCG monitoring including blood count and BHCG levels test and serial Transvaginal Ultrasound examination
15966497|NCT03138681|Drug|Placebo|placebo is given intravenously twice a day for 14 days
15966498|NCT03138681|Drug|ATP|ATP (100mg) is given intravenously twice a day for 14 days
15966499|NCT03138681|Drug|Phosphocreatine|Phosphocreatine (1g) is given intravenously twice a day for 14 days
15966500|NCT03138668|Drug|Ropivacaine Injection|"All 20 study participants will receive both treatment Low dose Ropivacaine and High dose Ropivacaine in form of a nerve block injection around the lateral femoral cutaneous nerve. Treatment Low dose Ropivacaine and High dose Ropivacaine will be randomized to be given in either right or left lower extremity. If the participant is randomized to receive treatment Low dose Ropivacaine in the right lower extremity, treatment High dose Ropivacaine will be given in the left lower extremity, and vice versa. Each participant will thus constitute as their own control."
15966564|NCT03138161|Drug|Ipilimumab|Ipilimumab is a human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody indicated for (1) treatment of unresectable or metastatic melanoma, and (2) adjuvant treatment of patients with cutaneous melanoma with pathologic involvement of regional lymph nodes of more than 1 mm who have undergone complete resection, including total lymphadenectomy.
15966501|NCT03138668|Drug|Ropivacaine Injection|"All 20 study participants will receive both treatment Low dose Ropivacaine and High dose Ropivacaine in form of a nerve block injection around the lateral femoral cutaneous nerve. Treatment Low dose Ropivacaine and High dose Ropivacaine will be randomized to be given in either right or left lower extremity. If the participant is randomized to receive treatment Low dose Ropivacaine in the right lower extremity, treatment High dose Ropivacaine will be given in the left lower extremity, and vice versa. Each participant will thus constitute as their own control."
15966502|NCT03138655|Drug|Vedolizumab|Vedolizumab IV infusion.
15966503|NCT03138642|Radiation|RT|All the patients receive extended resection to primary tumor and post-surgery RT. The patients are prescribed a EQD2 of 70-77Gy to GTV (residual tumor), 65-70Gy to CTV1(high-risk regions including tumor bed and gross macroscopic residual tumor), 50-55Gy to CTV2(low-risk regions) using Intensity-modulated radiotherapy (IMRT)
15966504|NCT03138629|Drug|VAL-083|VAL-083 will be administered intravenously
15966505|NCT03138616|Drug|vitamin D|take 1600 units of vitamin D daily for nine months
15966506|NCT03138603|Drug|Metoprolol Tartrate|Patients will receive up to 3 IV doses of study drug IV metoprolol tartrate 5mg) prior to extubation, and subsequently an oral dose 25mg metoprolol tartrate in the PACU, and then oral dosing at approx. every 8 hours thereafter through postop day 3 (72 hrs).
15966507|NCT03138603|Drug|Placebo|Patients will receive up to 3 IV doses of study drug placebo prior to extubation, and subsequently an oral dose placebo in the PACU, and then oral dosing at approx. every 8 hours thereafter through postop day 3 (72 hrs).
15966508|NCT03138590|Device|Transcranial Direct Current Stimulation- Neuroconn DC Stimulator PLUS|Transcranial Direct Current Stimulation targeting the trigeminal nerve
15966509|NCT03138577|Diagnostic Test|Ultrasound Imaging|"M-mode tracings of right diaphragm motion will be made and recorded by a skilled anesthesiologist. Patients will be examined in the supine position and scanned from a low intercostal or subcostal approach using the liver as an acoustic window. Patients will be asked to perform a voluntary sniff (VS) test, for which they will be asked to forcefully inhale through the nose in a sniffing position. The above measurement will be performed immediately preceding the brachial plexus blockade, and then at 15 minute and 30 minutes after block."
15966510|NCT03138577|Drug|Supraclavicular Block|The patient will be positioned supine with the head turned to the contralateral side. The ultrasound will be placed in the supraclavicular fossa, and the skin and subcutaneous tissues will be infiltrated lateral to the probe with 2% lidocaine. The anesthesiologist can redirect the needle and perform additional injections for complete coverage of the brachial plexus. The local anesthetic will be a 2:1 mix of 1.5% mepivacaine and 0.5% bupivacaine.
15966511|NCT03138577|Other|Bedside Negative Inspiratory Force Meter|A bedside negative inspiratory force (NIF) meter will be used to measure negative inspiratory force prior to the block and 30 minutes after the block.
15966512|NCT03138564|Behavioral|SPIRIT|"SPIRIT is a two-session, structured psychoeducational intervention assisting patients clarify their end-of-life preferences and helping surrogates understand the patient's wishes and prepare for the surrogate role.
~During the first session (about 45 minutes) individualized information is provided about the effectiveness of life-sustaining treatment for people with end-organ failure, and the care provider will assist the patient to examine his/her values about life-sustaining treatment. The surrogate will receive help preparing for end-of-life decision-making and the emotional burden of decision-making. A Goals-of-Care document will be completed to indicate the patient's preferences.
~Two weeks later, the second session (about 15 minutes) addresses remaining or new concerns. The patient's Goals-of-Care document will be reviewed. The patient's end-of-life preferences and surrogate's name and relationship to the patient will be documented in the medical record."
15966513|NCT03138564|Behavioral|Comparison Condition|As required by Centers for Medicare and Medicaid Services (CMS), written information on advance directives (ADs) is provided to a patient on the first day of dialysis, and a social worker reviews this information with patients and encourages them to complete an AD. This typically takes about 10 minutes.
15966514|NCT03138551|Behavioral|Mealtime PREP (Promoting Routines of Exploration and Play)|
15966515|NCT03138538|Drug|Part 1: M8891|Participants will receive M8891 orally once daily at escalated dose levels under fasting condition for consecutive 21-day cycles of continuous treatment until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
15966516|NCT03138538|Drug|Part 2A: M8891|Participants will receive a single dose of M8891 in the morning in fed conditions (Day -1, Cycle 1) followed by M8891 orally once daily at escalated dose levels under fasting conditions for consecutive 21-day cycles of continuous treatment until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
15966517|NCT03138538|Drug|Part 2B: M8891|Participants will receive M8891 at the dose level defined in the Part 2A once daily under fasting conditions in 21-day-cycles until disease progression, unacceptable toxicity, withdrawal of consent, or any criterion for withdrawal from the study.
15966518|NCT03138538|Drug|Cabozantinib|Participants will receive cabozantinib once daily orally along with M8891 under fasting condition until the participants no longer experiences clinical benefit or experiences unacceptable toxicity.
15966519|NCT03138525|Other|Blood sampling (MS)|Blood samples will be collected before initiation of Ocrelizumab treatment and after 6 and 12 months of treatment.
15966520|NCT03138525|Other|Blood sampling (controls)|Blood samples will be collected once at enrollment.
15966525|NCT03138499|Biological|Nivolumab|Specified dose on specified days
15966526|NCT03138499|Biological|Brentuximab vedotin|Specified dose on specified days
15966600|NCT03137862|Dietary Supplement|Gluten friendly bread 3g/day|"patients will have to continue the GFD supplemented with 3 gr of gluten friendly bread daily for 12 weeks"
15966601|NCT03137862|Dietary Supplement|Gluten friendly bread 6g/day|"patients will have to continue the GFD supplemented with 6 gr of gluten friendly bread daily for 12 weeks"
15966602|NCT03137849|Other|Yoga Poses|Yoga poses routine including specific muscles contractions known as bandhas (pelvic floor, core and throat/neck contraction) within each pose, which are advised to be done with steadiness and comfort.
15966527|NCT03138473|Diagnostic Test|Residual SYNTAX Score|"The baseline SYNTAX score and the residual SYNTAX score (rSS) are calculated by summing up the individual scores for each lesion with a diameter stenosis ≥50% in vessels with a diameter ≥ 1.5 mm in the angiography obtained before and after the procedure. The SYNTAX algorithm of scoring is fully described elsewhere.
~The modified Age, Creatinine, and Ejection Fraction (ACEF) score is calculated based on the age, creatinine clearance (CrCl) and left ventricular ejection fraction (LVEF), using the formula age/LVEF +1 point for every 10 ml/min/1.73 m2 reduction of CrCl below 60 ml/min/1.73 m2 (1 point for CrCl between 59 and 50, 2 points for CrCl between 49 and 40 and 3 points for CrCl between 39 and 30 ml/min/1.73 m2). The CrCl is calculated via the Cockroft-Gault equation using age, gender weight and serum creatinine before PCI. The baseline SYNTAX score was then multiplied by the modified ACEF score to obtain the baseline clinical SYNTAX score."
15966528|NCT03138473|Diagnostic Test|SYNTAX Revascularization Index|The SYNTAX Revascularization Index (SRI), representing the proportion of CAD burden treated by PCI, was calculated using the following formula: SRI= (1-[rSS/bSS]) ×100.
15966529|NCT03138460|Other|standard medications crossed over to cannabis|
15966530|NCT03138447|Device|Basal Insulin Titration Application|"Healthcare Providers (HCP) and the principal investigator (PI) will use an HCP portal to initiate a basal insulin titration algorithm. HCPs can customize the titration algorithm for every participant. Once a participant is prescribed an algorithm, they can download a mobile app on their phone with their HCPs corresponding titration plan. The app will prompt participants to enter their fasting glucose daily. Based on their fasting glucose and their HCPs titration plan, the application will display the participants daily basal insulin dose."
15966531|NCT03138421|Drug|ABX-1431 HCl|ABX-1431 HCl, capsules, 20 mg
15966532|NCT03138421|Drug|Placebo|Matching placebo
15966533|NCT03138408|Drug|SC-004|Intravenous
15966534|NCT03138408|Drug|ABBV-181|Intravenous
15966535|NCT03138395|Diagnostic Test|droplet digital PCR|This study will use our droplet digital PCR (ddPCR) method to quantify and track peripheral blood plasma MAF in MDS and AML patients before, during and after chemotherapy treatment. Quantification of MAF from fingersticks and saliva samples will also be performed to determine feasibility of obtaining adequate circulating tumor DNA (ctDNA) for ddPCR. Results from this project will generate a non-invasive means to monitor cancer response and progression months before current clinical methods, and provide an opportunity to intervene before the patient relapses.
15966536|NCT03138382|Device|Vestibular Nerve Stimulator|Electrical stimulation of the vestibular nerve with vestibular nerve stimulator (GVS device) for for 45 minutes using binaural mastoid placement.
15966537|NCT03138382|Device|Sham stimulator|Looks identical to vestibular nerve stimulator but discharges current into an internal resistor rather than activating the vestibular nerves.
15966538|NCT03138356|Drug|2.5 mg saxagliptin / 5 mg dapagliflozin / 850 mg metformin XR FDC tablet|Used in Treatment B and Treatment E.
15966539|NCT03138356|Drug|2.5 mg saxagliptin / 5 mg dapagliflozin / 1000 mg metformin XR FDC tablet|Used in Treatment A and Treatment D.
15966540|NCT03138356|Drug|5 mg dapagliflozin / 850 mg metformin XR FDC|Used in Treatment H.
15966541|NCT03138356|Drug|5 mg dapagliflozin / 1000 mg metformin XR FDC|Used in Treatment G.
15966542|NCT03138356|Drug|2.5 mg ONGLYZA® (saxagliptin) tablet|Used in treatments C and F.
15966543|NCT03138356|Drug|5 mg Forxiga® (dapagliflozin) tablet|Used in treatments C, F and I.
15966544|NCT03138356|Drug|500 mg Glucophage XR®|Used in treatments C, F and I.
15966545|NCT03138330|Other|this study is observational, it is not an intervention|
15966546|NCT03138317|Biological|PRP|This group will receive a knee injection with 6 ml of platelet rich plasma (PRP)
15966547|NCT03138317|Biological|Plasma|This group will receive a knee injection with 6 ml of plasma.
15966548|NCT03138317|Biological|Placebo|This group will receive a knee injection with 6 ml saline solution.
15966549|NCT03138304|Behavioral|Video game|Night Shift is an adventure video game with the transformational goal of teaching physicians key characteristics of patients with non-representative severe injuries - injuries classified by the American College of Surgeons as life-threatening or critical but that do not fit the archetype of injuries typically requiring treatment at a trauma center.
15966550|NCT03138304|Behavioral|Educational program|Two commercially available applications designed to teach physicians the trauma triage guidelines disseminated by the American College of Surgeons.
15966551|NCT03138291|Device|Somnodent|Each pregnant women will be treat with a Somnodent
15966552|NCT03138278|Other|Telephone support on demand|Dedicated phone number for help and advice for caregivers
15966553|NCT03138265|Behavioral|HIIT Device: ergometer|Supervised exercise training.
15966554|NCT03138252|Drug|Oxytocin|
15966555|NCT03138239|Radiation|Ga-68-PSMA scan, and PET -CT F-18-FDG|"The patient will do tow mappings on two different days. It should be noted that there is no importance to the order between the two tests on the condition that they be performed within 7-10 days of each other.
~Both tests will be performed with the Discovery 690 camera, which is located at the Nuclear Medicine Institute.
~First test PET-CT with F-18-FDG PET-CT second test with Ga-68-PSMA"
15966556|NCT03138226|Procedure|uterus transplantation|
15966557|NCT03138213|Procedure|Total laparoscopic pancreaticoduodenectomy|Total laparoscopic pancreaticoduodenectomy
15966558|NCT03138213|Procedure|Open pancreaticoduodenectomy|Open pancreaticoduodenectomy
15966559|NCT03138200|Biological|Blood transfusion|Blood transfusion is a safe, routine procedure in which blood is given to a patient through an intravenous cannula inserted into one of the patient's veins.
15966560|NCT03138187|Behavioral|Moderate exercise|The training phase of the moderate exercise group (MEG) will consist of 4 sets of 10 minutes walking/running at moderate intensity, with 5 minutes walking at low intensity for recovery between sets
15966561|NCT03138187|Behavioral|Vigorous exercise|The training phase of the vigorous exercise group (VEG) will consist of 4 sets of 10 minutes running at vigorous intensity, with 5 minutes walking at low intensity for recovery between sets
15966562|NCT03138174|Device|OneTouch Verio Flex Blood Glucose Monitoring System|Blood Glucose Monitoring System
15966563|NCT03138161|Drug|Trabectedin|Trabectedinis an alkylating drug indicated for the treatment of patients with unresectable or metastatic liposarcoma or leiomyosarcoma who received a prior anthracycline-containing regimen.
15966769|NCT03136458|Procedure|Ischemic preconditioning|Repeated remote ischemic preconditioning by arterial cuff insufflation.
15966565|NCT03138161|Drug|Nivolumab|A fully human immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death-1 (PD-1, PCD-1) with immune checkpoint inhibitory and antineoplastic activities. Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand (PD-L2), which is primarily expressed on APCs (antigen presenting cells). This results in the activation of T-cells and cell-medicated immune responses against tumor cells or pathogens. Activated PD-1 negatively regulates T-cell activation and plays a key role in tumor evasion from host immunity.
15966566|NCT03138148|Other|Routine mechanical ventilation|Routine mechanical ventilation in PICU amid children with acute respiratory failure
15966567|NCT03138135|Behavioral|HOME Study intervention|Access to home HIV test kits, home STI self-collection kits, the HOME Study website, and the SexPro HIV risk assessment tool.
15966568|NCT03138135|Behavioral|Control|Counseling about the importance of quarterly HIV/STI testing and a PrEP information pamphlet.
15966569|NCT03138096|Biological|Pb(PfCS@UIS4)-infected mosquitoes|Pb(PfCS@UIS4)-infected mosquitoes
15966570|NCT03138096|Other|Challenge infection P. falciparum|Challenge infection with bites of five infected Pf mosquitoes
15966571|NCT03138083|Drug|OMO-1|OMO-1 is a small molecule inhibitor of the enzymatic activity of the MET receptor tyrosine kinase
15966572|NCT03138070|Drug|BYL719|BYL719 400 mg daily by mouth continue for 14 days
15966573|NCT03138044|Procedure|Combined Treatment|This modality of palliative treatment includes initial surgical operation where arterial vascular supply of the tumor carrying liver lobe of the corresponding hepatic artery as well as the extrahepatic collateral arteries (EHCAs) feeding the large HCC (> 5 cms size) under general anesthesia. Four weeks after the operation the tumor is injeted (intralesionally and intravascularly) with absolute ethanol alcohol injections on regular weekly percutaneous sessions until the tumor become saturated and its vascularity rendered inactive.
15966574|NCT03138031|Procedure|Percutaneous ethanol alcohol injection|"Day-case procedure; weekly sessions; uses absolute alcohol; under close monitoring; maximum dose of 30 ml; no anesthesia needed and a maximum pain score of 8 limits the procedure. Post-procedure analgesia may be required."
15966575|NCT03138018|Diagnostic Test|Diagnosis of MCI versus No MCI (SCI or healthy patient)|Neuropsychological tests
15966576|NCT03138018|Diagnostic Test|Diagnosis of MCI versus No MCI (SCI or healthy patient)|Neuroimaging biomarkers of neurodegeneration
15966577|NCT03138005|Other|target SpO2 98-100%|Prehospital, post-ROSC oxygen maintained at ≥10L/minute of oxygen (equivalent to ~100% oxygen) into SGA/ETT if hand ventilated or 100% (i.e. FiO2 of 1.0) oxygen settings if mechanically ventilated. Patients will continue on treatment to handover in the ED. Between arrival at ED and first ABG in ICU, the oxygen setting may then be decreased provided SpO2 is maintained between 98-100%.
15966578|NCT03138005|Other|target SpO2 90-94%|Prehospital, post-ROSC oxygen reduced initially to 4L/minute (i.e. approximately 70% oxygen) into SGA/ETT if hand ventilated or an air mix setting if mechanically ventilated. If oxygen saturation remains ≥94% for 5 minutes, the oxygen flow rate will be further reduced to 2L/minute (i.e. approximately 46% oxygen) and hand ventilated to target an oxygen saturation between 90-94%. This treatment will continue to patient handover in the emergency department. Between arrival at ED and first ABG in ICU, oxygen will be titrated to target a oxygen saturation of 90-94%.
15966579|NCT03137992|Drug|Placebo|Single dose of placebo inhalation powder administered by test and reference dry powder inhalers.
15966580|NCT03137992|Drug|Test Product (tiotropium bromide inhalation powder)|Double-Blind: Single dose of test product 18 mcg of test product Open-Label: once daily administration of test product (tiotropium bromide inhalation powder) 18 mcg administered by test dry powder inhaler.
15966581|NCT03137992|Drug|Reference Product (Spiriva®)|Reference product (Spiriva®) 18 mcg.
15966582|NCT03137979|Biological|GMSCs and collagen scaffolds|Patients in this group were given GMSCs and collagen scaffolds.
15966583|NCT03137979|Biological|Collagen scaffolds|Patients in this group were given collagen scaffolds.
15966584|NCT03137979|Procedure|Open flap debridement|The patients in this group will only receive the treatment of open flap debridement.
15966585|NCT03137966|Drug|Deferoxamine|Deferoxamine (0.66mg/ml) will be applied locally as a gel (3 times a week) for a period of maximum three months or until intact skin.
15966586|NCT03137966|Drug|Placebo|Placebo will be applied locally as a gel (3 times a week) for a period of maximum three months or until intact skin.
15966587|NCT03137953|Procedure|Clinical Evaluation|The skin pinch test would be done by three independent oncologists to assess ability for skin conservation. The decision for skin conservation would be taken by the surgeon intra-operatively based on clinical and radiological assessments.
15966588|NCT03137953|Diagnostic Test|Radiological Imaging|Computed Tomography or Magnetic Resonance Imaging would be done by a radiologist and used to measure the distance between tumor and skin which would guide the decision for skin presevation. The decision for skin conservation would be taken by the surgeon intra-operatively based on clinical and radiological assessments.
15966589|NCT03137940|Device|real tDCS|one-shot of real tDCS session (1.5mA; 0.06 mA/cm2 for 20 minutes) with BrainStim Stimulator.
15966590|NCT03137940|Device|sham tDCS|one-shot of sham tDCS session (20 minutes) with BrainStim Stimulator.
15966591|NCT03137927|Biological|Vaccine GamLPV|live intranasal vaccine for whooping cough prevention
15966592|NCT03137927|Other|Placebo|Placebo
15966593|NCT03137914|Biological|Autologous chondrocyte transplantation|intraarticular injection into the TMJ (arthrocentesis) of autologous chondrocytes diluted in hyaluronic acid
15966594|NCT03137914|Procedure|orthognathic surgery|Orthognathic surgery for correction of dentofacial deformity, performed before the cellular transplantation
15966595|NCT03137901|Device|Capstesia|Picture of the arterial waveform taken with a smartphone
15966596|NCT03137888|Radiation|Dose-Escalated Radiation Therapy|Undergo sMRI-guided radiation therapy, dose painted to maximum of 75 Gy over six weeks
15966597|NCT03137888|Procedure|Spectroscopic Magnetic Resonance Imaging|Patients will undergo sMRI scans within a 14 day window prior to starting treatment
15966598|NCT03137888|Drug|Temozolomide|Given PO
15966599|NCT03137862|Other|Gluten free bread|patients will receive bread containing 3 g of cornstarch daily for 12 weeks; these patients will serve as controls
15966603|NCT03137849|Other|Breath Control|"Ujjayi pranayama (Victorious breath) Inhalation and exhalation are both done through the nose. The ocean sound is created by moving the glottis as air passes in and out. As the throat passage is narrowed so, too, is the airway, the passage of air through which creates a rushing sound. The length and speed of the breath is controlled by the diaphragm, the Strengthening of which is, in part, the purpose of ujjayi. The inhalations and exhalations are equal in duration."
15966604|NCT03137849|Other|Stretching exercises|Stretching exercises routine based on dynamic and static exercises excluding those similar to yoga poses. This routine works on great range of motion of all body joints and main muscles groups/ chains.
15966605|NCT03137836|Behavioral|Intervention|"Multi-level intervention focused on school environment (furniture) will be conducted.
~Device: Sit-to-stand desks (Ergotron LearnFit®); Device: (Actigraph, Pensacola, FL, USA); Device: ActivPALTM ."
15966606|NCT03137823|Diagnostic Test|throat culture|throat culture - from the tonsills and from the bucal surface
15966607|NCT03137810|Procedure|placental cord drainage|"In the study group a of total number of 90 women placental end of the cut umbilical cord 1st will be clamped for few seconds and then unclamped and left open to drain blood in a vessel until flow stoped. This will prevent the drained blood from getting mixed with blood lost in the 3rd stage.
~Blood loss in the third stage will be measured using a Kelly's pad which will be used during delivery and the blood lost will be collected in a clean metal bowl which will be kept at the tail end of Kelley's pad."
15966608|NCT03137810|Procedure|non placemtal cord drainage|In 90 women after vaginal delivery of the baby placental end of the cut umbilical cord will be kept clamped.
15966609|NCT03137784|Drug|NVA237 (glycopyrronium bromide)|In each treatment arm, patient will receive NVA237 (glycopyrronium bromide) 25 ug and 50 ug dose
15966610|NCT03137784|Drug|Placebo|In each treatment arm, patient will receive placebo
15966611|NCT03137771|Radiation|3-Dimensional Conformal Radiation Therapy (3D-CRT)|Undergo 3DCRT
15966612|NCT03137771|Drug|Docetaxel|Given IV
15966613|NCT03137771|Drug|Gemcitabine|Given IV
15966614|NCT03137771|Radiation|Intensity-Modulated Radiation Therapy (IMRT)|Undergo IMRT
15966615|NCT03137771|Drug|Pemetrexed Disodium|Given IV
15966616|NCT03137771|Radiation|Stereotactic Body Radiation Therapy (SBRT)|Undergo SBRT
15966617|NCT03137771|Drug|Erlotinib Hydrochloride|Given PO
15966618|NCT03137771|Drug|Pembrolizumab|Given IV
15966619|NCT03137758|Drug|PCUR - 101|PCUR-101 Capsules 25 mg are solid dosage forms for oral administration
15966620|NCT03137745|Other|thromboelastography|thromboelastography was done pre HIPEC ,post HIPEC and first and second postoperative days
15966621|NCT03137732|Device|Rectus Sheath Catheter|Insertion of rectus sheath catheter via either method
15966622|NCT03137706|Procedure|Biospecimen Collection|Undergo fresh tumor tissue collection
15966623|NCT03137706|Other|Laboratory Biomarker Analysis|Correlative studies
15966624|NCT03137706|Other|Laboratory Procedure|Tissue stiffness and cell viability analysis
15966625|NCT03137693|Other|Standard of Care Schedule Variation: SABR|SABR will be delivered over 3 days, prior to surgery.
15966626|NCT03137693|Procedure|Breast-conserving Surgery|Breast-conserving surgery will be scheduled for 6-8 weeks after SABR and will be conducted by a Moffitt breast surgeon.
15966627|NCT03137680|Behavioral|Hand Exercise|Exercise protocol for the intervention group will be to squeeze a soft ball 10 times for set and perform 3 sets of 10 squeezes each at an 1 minute interval. Three sets of exercises to be performed twice in the morning and twice in the evening, for a total of six weeks.
15966628|NCT03137667|Other|School-located Influenza Vaccination|Children in the intervention arm are enrolled in schools in Monroe County, New York that are offering school-located influenza vaccination clinics during school hours
15966629|NCT03137654|Other|Affective Training|Intervention includes up to 12 training sessions (~45 minutes each). Training sessions includes practice on cognitive tasks embedded with emotionally salient stimuli. Tasks include a dual modality n-back and a directed attend/ignore memory task.
15966630|NCT03137654|Other|Neutral Training|Intervention includes up to 12 training sessions (~45 minutes each). Training sessions includes practice on cognitive tasks embedded with neutral stimuli. Tasks include a dual modality n-back and a directed attend/ignore memory task.
15966631|NCT03137641|Other|Nurses urine samples|Collected urine samples from nurses in contact with antineoplastic drugs.
15966632|NCT03137628|Other|colectomy, GA and MV|"general anesthesia protocol: anesthesia induction (midazolam 0.1mg/kg, sufentanil 0.5ug/kg, etomidate 0.3mg/kg, cisatracurium 0.2mg/kg); anesthesia maintenance [sevoflurane 1.5-3%, cisatracurium 0.1mg/kg/h, sufentanil is supplemented during the entire surgical procedure according to patients' anesthetic situation, dexmedetomidine（used conditionally）0.4ug/kg/h].
~mechanical ventilation protocol: tidal volume 6-8 ml/kg, positive end-expiratory pressure 5 cmH2O, oxygen concentration 40%; respiratory rate 10-15/min, inspiratory/expiratory ratio 1:1.5."
15966633|NCT03137615|Procedure|Pituitary surgery|Trans-sphenoidal resection of a pituitary gland lesion.
15966634|NCT03137615|Drug|local anaesthetic injection|The surgeon infiltrates the nasal septum with local anaesthesia as per usual practice. This consists of Moffet's solution and lidocaine with adrenaline (1:200,000).
15966635|NCT03137602|Device|ATOMIC mobile app|(a) PA Coach, One-on-one Chats. Coaches will conduct three one-on-one phone or video conferencing sessions and will also conduct a text messaging session once per week to reinforce and follow-up on the one-on-one phone sessions during the course of the intervention. (b) PA-Self Monitoring. An activity tracker (Fitbit Charge 2) will be used to allow participants to monitor their activity behaviors (e.g. step counts). (c) PA Information. In addition the coach will send weekly tailored PA informational posts/messages aligned with Social Cognitive Theory (SCT) to all participants. (d) Educational Modules. MS specific web-based interactive PA modules will be provided to patients.
15966636|NCT03137589|Other|Telemedical support|Participating sites will be advised by telemedicine support.
15966637|NCT03137576|Procedure|Paravertebral Block (PVB)|PVB consists in the injection of low concentration Ropivacaine (30 ml, 0.3%) in the paravertebral space (defined by the anterior aspect of the ribs, the vertebral body and the parietal pleura. The space is identified under ultrasonographic guidance by a dedicated Anesthesiologist.
15966770|NCT03136458|Drug|Endovenous normal saline|endovenous normal saline 1 mL per Kg per hour before and after contrast media injection.
15966774|NCT03136419|Dietary Supplement|Placebo|Placebo supplementation for 8 weeks
15966638|NCT03137576|Procedure|Erector Spinae Plane Block (ESPB)|ESPB consists in the injection of low concentration Ropivacaine (30 ml, 0.3%), in the anatomical plane between the Erector Spinae muscles and deeper surface of Rhomboid muscle. The space is identified under ecographic guidance, laterally to the spinous process of T5. The diffusion of the anesthetic solution along the space can be echographically appreciated.
15966639|NCT03137563|Other|questionnaire|The questionnaire will be distributed and collected by the same investigator in one of the eight centers involved in the study. The investigator will verify the inclusion criteria and the absence of exclusion criteria.
15966640|NCT03137537|Drug|Ivabradine|lower heart rate in heart failure patients.
15966641|NCT03137537|Drug|Placebo Oral Tablet|Procedure prescribed to compare the active effect of a medicine.
15966642|NCT03137524|Device|Hand Held Fan Therapy|Hand-Held fan therapy used to generate airflow directed to face during specific exercise test
15966643|NCT03137511|Other|Taking photographs of suspicious lesions with his smartphone and sending them to the dermatologist|Taking photographs of suspicious lesions with his smartphone and sending them to the dermatologist
15966644|NCT03137498|Drug|Lidocaine|Lidocaine 1.5mg/kg IVPB in 50ml normal saline over 10 minutes x 1dose
15966645|NCT03137498|Drug|Ketorolac|Ketorolac 30mg (1ml) intravenous push injection x 1dose
15966646|NCT03137485|Procedure|Conventional open lumbar discectomy|Removal of single level lumbar disc herniation through conventional discectomy.
15966647|NCT03137485|Procedure|Percutaneous Endoscopic Translaminar lumbar discectomy.|Removal of single level Lumbar disc herniation using endoscope.
15966648|NCT03137485|Device|Easy Go system Endoscopy|This system will be used to remove herniated disc in endoscopic group
15966649|NCT03137472|Device|Transcranial Magnetic Stimulation (TMS)|The Magventure TMS stimulator will be used to perform intermittent theta burst followed by high frequency Transcranial Magnetic Stimulation (TMS).
15966650|NCT03137459|Behavioral|Transtheoretical Model (TTM) of health behavior change|Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. The system takes the results of the assessment and results in an individualized feedback report. For individuals in early stages of change for a given behavior, the feedback focuses on changing attitudes, a necessary prerequisite for changing behavior, by addressing common barriers and by reminding individuals they can engage in small steps.
15966651|NCT03137459|Other|Usual Care|Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. Participants in this group will not receive any components of the TTM intervention.
15966652|NCT03137446|Other|Intravenous Fluid Cap|Normal Saline or Ringers Lactate limited to 60ml/kg for first 72 hours
15966653|NCT03137433|Dietary Supplement|Meal-replacement Therapy|We seek to examine the effect of meal-replacement therapy on weight loss outcomes in teens with severe obesity.
15966654|NCT03137420|Diagnostic Test|Numeric Scale of Family Distress|Questionnaires at 1, 3, 6 and 12 months
15966655|NCT03137407|Biological|Botulinum Toxins, Type A|Intramuscular injection
15966656|NCT03137407|Biological|Placebo|Intramuscular injection
15966657|NCT03137394|Other|Observation|Data for each participant in the SCI group will be collected at baseline, 6 months, and 1 year post injury; control group data will be collected at baseline and at the 1-year follow-up.
15966658|NCT03137381|Drug|CTP-543|tablets
15966659|NCT03137381|Drug|Placebo|tablets
15966660|NCT03137368|Drug|Exemestane Tablets|drug therapy
15966661|NCT03137368|Other|ovarian function suppression/ablation|Gonadotropin-releasing hormone analogue Goserelin Injection 3.6mg or Leuprorelin Injection 3.75 mg, a subcutaneous injection should be done every 28±2 days; or Bilateral ovariectomy.
15966662|NCT03137368|Genetic|CYP2D6*10 gene test|CYP2D6*10 gene test
15966663|NCT03137368|Drug|Tamoxifen|drug therapy
15966664|NCT03137342|Behavioral|Pepped on PrEP Package|A counseling and problem-solving adherence intervention with a Behavioral Activation approach to re-engage participants in safe but pleasurable activities in life and addresses stimulant abuse as well as associated factors, including depression, as barriers to optimal PrEP adherence.
15966665|NCT03137329|Behavioral|Exercise program|Physical therapy for aerobic and resistance training exercises
15966666|NCT03137329|Dietary Supplement|Nutrition|Nutrition supplementation via HMR for lifestyle arm only
15966667|NCT03137329|Procedure|WLS|Weight loss surgery as planned
15966668|NCT03137316|Diagnostic Test|intact parathyroid hormone level|obtain intact parathyroid hormone level from patients records.
15966669|NCT03137303|Device|Spirometry at initial visit|Initial visit for the intervention group, an initial demographics form and health questionnaires. To evaluate the breathing, a pre and post broncho dilator will be performed as well as a spirometry test.
15966670|NCT03137303|Drug|Albuterol|The post broncho dilator spirometry test will be preformed after a breathing medication called Albuterol. Albuterol is used in standard practice for COPD and is commonly used during spirometry.
15966671|NCT03137303|Device|Spirometry at 12-month follow-up|At the end of the 1 year followup, the patient will be scheduled for a pre and post BD spirometry test and undergo the same spirometry protocol as the intervention group.
15966672|NCT03137290|Drug|Neostigmine|The TOF Watch Sx, and Paediatric Bispectral Index (BIS) monitoring were put on patient. Gaseous induction, with oxygen and Sevoflurane was given until BIS was 40-50, then a intravenous line was obtained. 2 mcg/kg of fentanyl was given for analgesia. then,the TOF Watch Sx was calibrated.The patient was paralyzed with 0.6mg/kg of rocuronium, and intubation of the trachea was done once TOF count was less than 1. A maintenance of 0.2 mg/kg of Rocuronium was given boluses every 30 minutes to maintain TOF count between 2-3. At the end of surgery, TOF count was checked to ensure it was between 2-3. Then a reversal dose for TOF count of 2 to 3 was 0.05 mg/kg of Neostigmine with 0.02 mg/kg of Atropine. Therefore the volume would be 0.2 mls per kg is to be administered.
15966771|NCT03136445|Drug|Tranexamic acid (TXA).|IV or oral preparation. IV tranexamic acid or Oral tablet of tranexamic acid.
15966772|NCT03136445|Drug|Placebo|IV (saline) or oral placebo tablets
15966673|NCT03137290|Drug|Sugammadex Sodium|The TOF Watch Sx, and Paediatric Bispectral Index (BIS) monitoring were put on patient. Gaseous induction, with oxygen and Sevoflurane was given until BIS was 40-50, then a intravenous line was obtained. 2 mcg/kg of fentanyl was given for analgesia. then,the TOF was calibrated.The patient was paralyzed with 0.6mg/kg of rocuronium, and intubation of the trachea was done once TOF count was less than 1. A maintenance of 0.2 mg/kg of Rocuronium was given boluses every 30 minutes to maintain TOF count between 2-3. At the end of surgery, TOF count was checked to ensure it between 2-3. Then the dose for reversal of sugammadex with a TOF count of 2 or 3 would be 2 mg/kg. This will also be equivalent to a volume of 0.2 mls per kg and given at the end of surgery.
15966674|NCT03137277|Procedure|screening colonoscopy|"Introduction and forwarding of the device up to caecum/terminal ileum. Then withdrawal and inspection of colonic wall. Biopsies and polypectomies if necessary. overall and diagnostic (only withdrawal) times being recorded separately.
~Polyps are documented with regards to location (caecum, ascending, transverse and descending colon, sigmoid and rectum), size (open forceps or snare for comparison) and morphology using the Paris classification (polypoid pedunculated or sessile, non-polypoid slightly elevated/flat/depressed, ulcerous) Polyps were then resected using biopsy forceps or cold snare (for polyps < 5 mm), or conventional polypectomy according to local standards."
15966675|NCT03137264|Drug|Other|Patients who are T790M positive via cobas plasma and/or cobas tissue testing during Part 1 will be treated per standard of care during Part 2, which may include osimertinib.
15966676|NCT03137251|Device|TENS 1|A portable TENS unit will be used by the principal investigator to apply the experimental intervention. Two pairs of electrodes measuring 5 x 9 cm will be fixed on the paravertebral regions of the participants of the experimental group using hypoallergenic surgical tape. Two paired electrodes will be placed 1 cm laterally on either side of the spine at the T10 to L1 and S2 to S4 levels.
15966677|NCT03137251|Device|TENS 2|An intervention similar to arm 1 will be performed but with different doses.
15966678|NCT03137251|Device|Placebo TENS|An intervention similar to arm 1and 2 will be performed but,in this case, it is a sham device.
15966679|NCT03137238|Other|Investigation of self-perception in Parkinson's disease|There is no therapeutic intervention.
15966680|NCT03137225|Device|Neurally Adjusted Ventilatory Assist|Neurally Adjusted Ventilatory Assist delivered via RAM cannula .
15966681|NCT03137225|Device|Nasal Intermittent Positive Pressure Ventilation|Nasal Intermittent Positive Pressure Ventilation delivered via RAM cannula
15966682|NCT03137212|Combination Product|thrombolysis and PCI of A type|STEMI patients first are given thrombolysis and then transfer to PCI centers to be treated by PCI 3-6 hours after thrombolysis.
15966683|NCT03137212|Combination Product|thrombolysis and PCI of B type|STEMI patients first are given thrombolysis and then transfer to PCI centers to be treated by PCI 6-24 hours after thrombolysis.
15966684|NCT03137199|Biological|hMSCs|intravenous infusion of bone marrow-derived allogeneic stem cells
15966685|NCT03137186|Drug|Metformin|Metformin will be added as a daily treatment to the standard treatment in both neoadjuvant and adjuvant settings of locally advanced cases and lifelong to metastatic cases. The starting daily dose of metformin is 850mg Once daily, to be increased to 850 mg if tolerated
15966686|NCT03137173|Drug|ceftobiprole medocaril|ceftobiprole 500 mg was to be administered every 8 hours as a 2-hour IV infusion (with dose adjustment for renal impairment). The treatment duration was for a minimum of 5 days and a maximum of 10 days. Treatment could be extended up to 14 days if in the investigator's opinion this was required, and the extension was approved by the sponsor's medical monitor.
15966687|NCT03137173|Drug|vancomycin+aztreonam|"Vancomycin 1000 mg (or 15 mg/kg) was to be administered every 12 hours (with dose adjustment for renal impairment) as 2-hour IV infusion. Vancomycin dose adjustment for morbidly obese and hypermetabolic patients was to be done according to local standard of care. When locally available, vancomycin trough testing (VTT) might have been used by the unblinded pharmacist or delegate to adjust the vancomycin dose. The treatment duration was for a minimum of 5 days and a maximum of 10 days. Treatment could be extended up to 14 days if in the investigator's opinion this was required, and the extension was approved by the sponsor's medical monitor.
~Aztreonam 1000 mg was to be administered as a 0.5-hour IV infusion every 12 hours. If CLCR was < 30 mL/min (i.e., severe renal impairment), the aztreonam dosage regimen was to be adjusted. The requirement to continue aztreonam therapy beyond Day 3 was to be reassessed at the 72-hour study visit."
15966688|NCT03137160|Biological|Ixekizumab|Injection
15966689|NCT03137147|Behavioral|Intervention for Sleep and Pain in Youth|See arm description.
15966690|NCT03137134|Drug|Crizotinib|Crizotinib in a coated microsphere formulation
15966691|NCT03137134|Drug|Esomeprazole|Proton pump inhibitor, esomeprazole
15966692|NCT03137121|Drug|Olanzapine|Olanzapine is used as an anti-emetic.
15966693|NCT03137121|Other|Placebo|The placebo is a non-anti-emetic.
15966694|NCT03137108|Device|Transcutaneous electrical spinal cord stimulation|Study intervention consists of the application of tSCS at three different frequencies (15 Hz, 30 Hz, 50 Hz) using the CE certified electrostimulator RehaMove 3. Stimulation will only be applied by an investigator during the two testing sessions. During the overground walking, the participants will be secured and assisted with the cable-driven body-weight support system FLOAT.
15966695|NCT03137095|Other|Cognitive testing|computerized and paper-based cognitive tests that assess memory, executive function, processing speed and concentration performed at Assessments 1, 3, 4.5 & 5.
15966696|NCT03137095|Other|Research Brain MRI|Optional sub-study participation includes undergoing research brain MRI to obtain structural and functional brain images at Assessment 4.5 and 6.
15966697|NCT03137082|Drug|Guanfacine XR 3mgs/daily|Guanfacine 3mg tablet
15966698|NCT03137082|Drug|Placebo (for guanfacine)|Sugar pill manufactured to mimic guanfacine tablets
15966699|NCT03137069|Drug|GDC-0853|GDC-0853 will be administered orally at dosages of 50, 150 and 200mg to participants, as per the dosing schedules described above.
15966700|NCT03137069|Drug|Placebo|Matching Placebo will be administered orally, as per the dosing schedules described above.
15966701|NCT03137056|Device|Hemodialysis with Theranova|"Theranova is a polyarylethersulfone-based hemodialysis membrane manufactured by Baxter International Corp All the dialysis sessions in this arm will be performed with the theranova membrane. This membrane will exclusively be used in hemodialysis.
~Modalities of hemodialysis : Blood flow: 300-400 mL/min; Dialysate flow: 500-800 mL/min"
15966886|NCT03135795|Drug|Rocuronium|Patients received intravenous rocuronium 0.6mg/Kg for induction.
15966702|NCT03137056|Device|Hemodialysis with FX1000|"FX1000 is a helixone-based membrane manufactured by Fresenius All the dialysis sessions in this arm will be performed with the FX1000 membrane. This membrane will be used in hemodialysis.
~Modalities of hemodialysis: Blood flow: 300-400 mL/min ; Dialysate flow: 500-800 mL/min"
15966703|NCT03137056|Device|Hemodiafiltration with FX1000|FX1000 is a helixone-based membrane manufactured by Fresenius All the dialysis sessions in this arm will be performed with the FX1000 membrane. This membrane will be used in hemodiafiltration Modalities of hemodialysis: Blood flow: 300-400 mL/min; Dialysate flow: 500-800 mL/min ; post reinjection convection volume of at least 25L.
15966704|NCT03137043|Other|Questionnaire|Subjects will be given an Electronic Case Report Form (eCRF) with a series of questionnaire such as Asthma Control Test, Morisky-Green Questionnaire and St George's Respiratory Questionnaire.
15966705|NCT03137043|Other|Software of Big Data|Software of big data is a powerful data treatment algorithm works closely with Spanish Data Protection Agency as an example on how to reuse clinical information without conflicting with necessary data privacy. The system will process a vast amount of information (big data), so that the impact of random errors will be minimized.
15966706|NCT03137030|Drug|GRT7014 - Abuse Deterrend Tablet|Single oral dose in one of the four cross-over trial periods and in the standard cross-over trial periods.
15966707|NCT03137030|Drug|Norco 5Mg-325Mg Tablet|Single oral dose in one of the four cross-over trial periods and in the standard cross-over trial periods.
15966708|NCT03137017|Drug|Norco 5Mg-325Mg Tablet|Single oral dose in one of the four cross-over trial periods.
15966709|NCT03137017|Drug|GRT7014 - Abuse Deterrent Tablet|Single oral dose in one of the four cross-over trial periods.
15966710|NCT03137004|Drug|Docetaxel|Docetaxel 50mg/m2 in 60 min on day 1 and repeated every 14 days.
15966711|NCT03137004|Drug|S-1|S-1 was administered orally at 40 mg/m2 twice daily on days 1-7 of each cycle. Patients with a body surface area of less than 1.25 m2 received 80 mg S-1 daily, those with a body surface area of 1.25 m2 or more but less than 1.5 m2 received 100 mg S-1 daily, and those with a body surface area of 1.5 m2 or more received 120 mg S-1 daily.
15966712|NCT03136991|Drug|AZD4831|Participants will receive AZD4831 once daily, orally, for a period of 10 days. Note: Additional doses (for cohorts 2,3&4) are provisional and could be adjusted based on the emerging data after the review of all available safety or other pertinent data from the previous dose by the Safety Review Committee (SRC).
15966713|NCT03136991|Drug|Placebo|Participants will receive placebo matching the AZD4831 dose, once daily, orally, for a period of 10 days.
15966714|NCT03136978|Diagnostic Test|Evaluation of M1 and M2 macrophages by flow cytometry.|To assess surface expression of macrophage markers, tissue samples will be stained for flow cytometry with fluorochrome-conjugated monoclonal antibodies against CD14, CD68, CCR7 and CD80 to identify M1, whereas fluorochrome-conjugated monoclonal antibodies against CD14, CD68, CD163 and CD206 to identify M2.
15966715|NCT03136965|Biological|PRP|Injection of autologous platelet rich plasma (PRP)
15966716|NCT03136965|Procedure|Dry Needling|This is a therapeutic procedure that involves the same injection procedures under ultrasound guidance as in the PRP group but no PRP will be injected inside the patellar tendon.
15966717|NCT03136965|Procedure|Dry Needling - Sham|This is a sham procedure that involves similar injection procedures under ultrasound guidance as in the PRP and DN groups with no injection of PRP or needle placement inside the patellar tendon.
15966718|NCT03136952|Device|NIRS frontal and occipital|NIRS frontal and occipital on pediatric population during general anesthesia
15966719|NCT03136939|Other|No intervention|No intervention
15966720|NCT03136913|Device|Cytoplast® TXT-200|Non-resorbable membrane
15966721|NCT03136913|Device|MinerOss® Cortical and Cancellous Chips (FDBA)|Mixture of allograft mineralized cortical and cancellous chips
15966722|NCT03136913|Procedure|Open Flap Technique|After extraction, the socket wound is left open to heal by secondary intention
15966723|NCT03136913|Procedure|Closed Flap Technique|After extraction, the socket wound is closed by primary closure
15966724|NCT03136900|Dietary Supplement|Nutrilon without lactose® fortified by concentration|enteral diet with cow milk protein-based infant formula without lactose 20% in place of 14%
15966725|NCT03136900|Dietary Supplement|Nutrilon without lactose® fortified by Maltodextrin and oil supplementation|enteral diet with cow milk protein-based infant formula without lactose 14%
15966726|NCT03136887|Device|JOURNEY II XR Total Knee System|JOURNEY II XR Total Knee System
15966727|NCT03136874|Other|Interview and questionaires|"Quantitative method : Two questionnaires will be used to define sociodemographic data, motivations and personality traits of donors.
~Qualitative method : Clinical interviewing allows data collection adapted to study the motivations of sperm/egg donors, their representations, the experience and the inscription of the donation in their personal stories."
15966728|NCT03136861|Biological|AIN457|anti IL-17a monoclonal antibody
15966729|NCT03136861|Drug|AIN457 Placebo|Placebo matching AIN457
15966730|NCT03136848|Drug|Normothermic ex-vivo kidney perfusion Solution -Toronto|"The perfusion device will circulate warmed, oxygenated blood-based perfusate (Normothermic ex-vivo kidney perfusion solution-Toronto) through the kidney."
15966731|NCT03136835|Drug|Maternal Hyperoxygenation|Oxygen via nasal prongs at 4L/min continuously during 2nd and 3rd trimester of pregnancy until birth
15966732|NCT03136822|Other|Standard Dressing|Standard dressing is applied for treatment of diabetic foot ulcers
15966733|NCT03136822|Device|DERMALIX|DERMALIX, a class III Medical Device will be applied in addition to standard dressing
15966734|NCT03136809|Drug|Cu(II)ATSM|copper-containing synthetic small molecule
15966735|NCT03136796|Drug|Meropenem|Patients will receive intravenous antibiotics eighter empirically or based on a culture.
15966736|NCT03136783|Other|Development of the most specific physiologically relevant experimental patient models|Development of the most specific physiologically relevant experimental patient models: organotypic culture of biopsies, reconstituted skin (equivalents of dermis with melanoma, dermis equivalents and epidermis with melanoma), and in vitro evaluation The response of tumor cells to different combinations of targeted therapy molecules
15966737|NCT03136770|Dietary Supplement|CK-30|Compound K 600 mg
15966738|NCT03136770|Dietary Supplement|Red ginseng extracts|Red ginseng extracts 2.94 g
15966773|NCT03136419|Dietary Supplement|Lactobacillus casei DG|Lactobacillus casei DG probiotic supplementation for 8 weeks
15966739|NCT03136757|Other|Transcriptomic analysis of GVHD biopsies|"The transcriptomic analysis of GVHD biopsies aims at:
~to demonstrate an evocative or even specific molecular profile, making the diagnosis of GVHD easier
~to identify new intracellular signaling pathways that could lead to new therapeutic"
15966740|NCT03136744|Behavioral|Sit Less with MS|The Sit Less with MS intervention has a total duration of 16 weeks and consists of two stages: sit less and move more stages. During the first stage (sit less), we will conduct coaching sessions with participants every week and the focus will be on interrupting their sitting time every 30 minutes. Facebook and Twitter will be also used to provide information and supplement coaching sessions. During the second stage, the focus will be on encouraging the participants to move more by replacing sitting with light intensity activities frequently throughout waking hours.
15966742|NCT03136718|Other|Mobile-enabled RLOs (mRLOs)|A theoretically-driven, personalised educational intervention delivered through mobile technologies based on the C2Hear (https://www.youtube.com/C2HearOnline) RLOs. The mRLO intervention will include shorter 'bite-sized' RLOs suitable for mobile technologies. This will allow a unique dynamic tailoring approach, whereby relevant mRLOs will be provided based on the user's responses to a self-evaluation filter aid, which will enable individualised, tailored learning.
15966743|NCT03136705|Drug|Nicotinamide|Nicotinamide tablet
15966744|NCT03136705|Drug|Lanthanum Carbonate|Lanthanum Carbonate tablet
15966745|NCT03136705|Drug|Lanthanum Carbonate Placebo|Sugar pill manufactured to look like Lanthanum Carbonate tablet
15966746|NCT03136705|Drug|Nicotinamide Placebo|Sugar pill manufactured to look like Nicotinamide tablet
15966747|NCT03136692|Behavioral|Lose It! commercial weight loss app|Lose It! is a commercial weight loss smart phone app designed for easy caloric tracking. It provides a free mobile and web interface for users to construct an individualized weight loss plan by entering their goal weight and desired weekly weight loss. Using the user's height, current weight, gender and age, the app generates a daily caloric budget designed for the user to reach their goal. Users can then log their caloric intake, exercise, and weight to track progress toward their goal.
15966748|NCT03136666|Drug|Nifedipine gastrointestinal therapeutic system (GITS) (Adalat LA, BAY a1040) + Candesartan cilexetil|Candesartan and nifedipine were administered together as loose combination with 240 mL non-sparkling water in the morning after a fasting period of at least 10 hours.
15966749|NCT03136653|Biological|MP0250 plus BOR+DEX|"6 mg/kg or 8 mg/kg or 12 mg/kg of MP0250, IV (in the vein,) on day 1 of each 21 day cycle. Bortezomib and Dexamethasone according to label.
~Number of Cycles: until progression or unacceptable toxicity develops."
15966751|NCT03136627|Drug|Tivozanib|Tivozanib (AV-951): Phase 1b study and Phase 2a study: Subjects will receive 1 dose of tivozanib daily for 21 days followed by a 7 day rest period (1 cycle = 4 weeks).
15966752|NCT03136627|Drug|Nivolumab|Nivolumab: Phase 1b study and Phase 2a study: All subjects will receive IV nivolumab 240 mg every 2 weeks administered over 1 hour.
15966753|NCT03136614|Device|Arteriograph|
15966754|NCT03136601|Other|PTNS maintenance|The intervention is the timing of PTNS for maintenance (monthly treatment versus as patient needs)
15966755|NCT03136588|Device|Feedback using ICT based monitoring system|In case of a missed immunosuppressant dose, the first violation does not generate a feedback while the second one does within one hour at the break of the ±3 hour range from the fixed dosing time. Up to two additional alarms/texts are sent at an interval of 30 minutes if the dose is still not taken after the feedback. For any discrepancy between the dosage taken and the dosage prescribed, a feedback is sent within 1 hour from the moment of recognition. Again, the first violation goes without response, while any violation after that generates feedbacks. Similarly, if a dose is taken outside of the allowed ±3 hour dosing time range, a feedback is sent within 1 hour of recognition, starting with the second violation.
15966756|NCT03136575|Behavioral|Qigong|a 30 minutes exercise program, 3 times a week and lasts for 6 weeks during radiotherapy course
15966757|NCT03136575|Behavioral|Wait-list control|patients enrolled in this group are informed orally to have exercise only and are arranged in a waiting list
15966758|NCT03136562|Diagnostic Test|Synacthen test|250 microg synacthen test performed fasting, in the morning. P-cortisol measured before and 30 minutes after Synacthen injection.
15966759|NCT03136549|Other|Thermo-softening|The thermosoftening treatment of the tubes was performed by using a warm cabinet set to 45°C (approximately 117°F). One bottle of normal saline (1 L) containing a thermometer and three tubes (6.0 -7.0 mm ID) was put into a chamber of the cabinet 30 min before intubation.
15966760|NCT03136549|Other|Room temperature|nasotracheal tube, sized 6.0 -7.0 mm inner diameter (ID), were put into a bottle of sterilized normal saline (1 L, 25 °C) at room temperature.
15966761|NCT03136510|Drug|Apixaban 5 mg|"Bood collection for biological analyses at:
~inclusion visit
~follow-up visit at 1 month
~end of research at 3 month"
15966762|NCT03136497|Drug|ABT-199|Oral dose daily until disease progression
15966763|NCT03136497|Drug|Ibrutinib|Oral dose daily until disease progression
15966764|NCT03136497|Drug|Rituximab|Rituximab will be administered IV per institutional standards. weekly X 4 (Cycle 1); once on Day 1 of cycles 2-6 only, then every other cycle until Cycle 24 (total 18 doses of Rituxan from C1D1
15966765|NCT03136484|Drug|Semaglutide|Following a dose escalation phase of 8 weeks, semaglutide 1.0 mg once-weekly(administered subcutaneously, s.c., under the skin) and canagliflozin placebo once-daily (administered orally, as a tablet). Subjects will continue on their pre-trial daily dose of metformin.
15966766|NCT03136484|Drug|Canagliflozin|Following a dose escalation phase of 8 weeks, canagliflozin 300 mg once-daily (administered orally, as a tablet) and semaglutide placebo (administered subcutaneously, s.c., under the skin). Subjects will continue on their pre-trial daily dose of metformin.
15966767|NCT03136484|Drug|Placebo (canagliflozin)|Following a dose escalation phase of 8 weeks, semaglutide 1.0 mg once-weekly(administered subcutaneously, s.c., under the skin) and canagliflozin placebo once-daily (administered orally, as a tablet). Subjects will continue on their pre-trial daily dose of metformin.
15966768|NCT03136484|Drug|Placebo (semaglutide)|Following a dose escalation phase of 8 weeks, canagliflozin 300 mg once-daily (administered orally, as a tablet) and semaglutide placebo (administered subcutaneously, s.c., under the skin). Subjects will continue on their pre-trial daily dose of metformin.
15966775|NCT03136406|Drug|Cyclophosphamide|2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate
15966776|NCT03136406|Drug|Oxaliplatin|cis-[(1 R,2 R)-1,2-cyclohexanediamine-N,N'] [oxalato(2-)- O,O'] platinum
15966777|NCT03136406|Drug|Capecitabine|5'-deoxy-5-fluoro-N-[(pentyloxy) carbonyl]-cytidine
15966778|NCT03136406|Drug|5-Fluorouracil|5-fluoro-2,4 (1H,3H)-pyrimidinedione
15966779|NCT03136406|Drug|Leucovorin|L-Glutamic acid, N-[4-[[(2-amino-5-formyl-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-, calcium salt
15966780|NCT03136406|Drug|nab-paclitaxel|Benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-y1ester,(αR,βS)-(9CI) bound to albumin
15966781|NCT03136406|Biological|bevacizumab|Recombinant human anti-VEGF IgG1 monoclonal
15966782|NCT03136406|Biological|avelumab|Recombinant human anti-PD-L1 IgG1 monoclonal antibody
15966783|NCT03136406|Biological|ALT-803|Recombinant human super agonist interleukin-15 (IL-15) complex
15966784|NCT03136406|Biological|aNK for Infusion|NK-92 cells
15966785|NCT03136406|Biological|ETBX-011|Ad5 [E1-, E2b-]-CEA
15966786|NCT03136406|Biological|GI-4000|Vaccine derived from recombinant Saccharomyces cerevisiae yeast expressing mutant Ras proteins
15966787|NCT03136393|Behavioral|Community based dietary counselling|The dietary counseling will be delivered to mothers through group sessions (will include cooking demonstration) and home visits by lay health workers. The counseling will promote foods that are nutritious and locally available and general better food preparation practices. The choices of the foods to be promoted will be based on linear programming results from a preceding survey on dietary intake of pregnant women in the area as well as results of analysis of foods associated with infant birth size (same data). The goal in the linear programming was to find a model of food combinations among the most frequently consumed foods which better meets required intakes during pregnancy. Additionally, adherence to pregnancy iron supplements will also be promoted.
15966788|NCT03136393|Behavioral|Community based antenatal counselling|The antenatal counselling will focus on preparations for neonatal care and encouragement for facility based delivery.
15966789|NCT03136380|Drug|GSK1325756H|Danirixin will be available as 10 and 50 milligram (mg) white film coated, round and oval tablets intended for oral administration. It will be administered with 240 mL of water.
15966790|NCT03136380|Drug|Placebo|Subjects will receive visually matching danirixin placebo tablets. It will be administered with 240 mL of water.
15966791|NCT03136367|Other|Option Grid|The Option Grid(TM) encounter decision aid for early stage breast cancer surgery is a one-page, evidence-based summary of available options presented in a tabular format.
15966792|NCT03136367|Other|Picture Option Grid|The Picture Option Grid was derived from the Option Grid for early stage breast cancer. It uses the same evidence and integrates images and simpler text, thus exploiting pictorial superiority. The Picture Option Grid has been specifically designed for women of lower SES and low health literacy.
15966793|NCT03136354|Procedure|Endoscopic Submucosal Dissection|
15966794|NCT03136354|Procedure|Laparoscopic assisted Gastrectomy|
15966795|NCT03136341|Drug|Abobotulinum toxin A|Dosing will be determined at each study visit based upon muscles involved
15966796|NCT03136341|Other|Placebo|Dosing will be determined at each study visit based upon muscles involved
15966797|NCT03136328|Drug|68Ga-DOTATOC|The intervention is to administer 68Ga-DOTATOC PET/CT for detecting NET.
15966798|NCT03136315|Other|INFERNAL Intervention|The intervention consists in serum and urinary dosage (creatinine and Cystatin C) at the beginning and the end of the 110 km race.
15966799|NCT03136302|Procedure|Deep Brain Stimulation|Deep Brain Stimulation
15966800|NCT03136289|Behavioral|Family Consumer Behaviors|The relationship between family consumer behaviours (healthy food availability and supermarket spending) and adolescent prediabetes and diabetes.
15966801|NCT03136276|Other|IPS Empress CAD|standard etchable glass ceramics
15966802|NCT03136276|Other|polished Celtra Duo|new glass ceramic material
15966803|NCT03136263|Drug|Oxytocin nasal spray|Single-dose intranasal oxytocin (24 IU; Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland)
15966804|NCT03136263|Drug|Placebo nasal spray|Single-dose intranasal placebo (inactive ingredients of Syntocinon® nasal spray, Victoria Pharmacy, Zürich, Switzerland)
15966805|NCT03136250|Other|Group A (Control Group - Static Stretching + Standard Treatment)|o Conventional Gold Standard treatment (Manual Therapy + Modalities) Conventional Static Stretching 15-30 seconds hold 3-5 repetitions (Page P, 2012) for Ant/Middle/Posterior Scaleni, Sternocleidomastoid, Levator Scapulae and Upper Trapezius Muscles.
15966806|NCT03136250|Other|Group B (Autogenic Inhibition - PIR + Standard treatment)|o Conventional Gold Standard treatment (Manual Therapy + Modalities) Post Isometric Relaxation MET (3-5 reps) for Ant/Middle/Posterior Scaleni, Sternocleidomastoid, Levator Scapulae and Upper Trapezius Muscles. (Chaitow L, 2006)
15966807|NCT03136250|Other|Group C (Reciprocal Inhibition - RI + Standard treatment)|o Conventional Gold Standard treatment (Manual Therapy + Modalities) Reciprocal Inhibition MET (3-5 reps) for Ant/Middle/Posterior Scaleni, Sternocleidomastoid,Levator Scapulae and Upper Trapezius Muscles (Chaitow L, 2006)
15966808|NCT03136237|Drug|BCX7353|Day 11-18 for Cohort 1, Day 7-14 for Cohort 2, Day 1 for Cohort 3
15966809|NCT03136237|Drug|Digoxin|Day 1 of Cohort 1
15966810|NCT03136237|Drug|BCX7353 + digoxin|Day 19 of Cohort 1
15966811|NCT03136237|Drug|Rosuvastatin|Day 1 of Cohort 2
15966812|NCT03136237|Drug|rosuvastatin + BCX7353|Day 15 of Cohort 1
15966813|NCT03136237|Drug|Cyclosporine + BCX7353|Day 14 of Cohort 3
15966814|NCT03136224|Device|Thermocautery|
15966815|NCT03136224|Device|Plastic Clamping|
15966816|NCT03136224|Device|Surgical Circumcision|
15966887|NCT03135795|Drug|sevoflurane|Patients received inhalation of sevoflurane (1-2%) for maintenance.
15966888|NCT03135795|Drug|remifentanil|Patients received intavenous pump of remifentanil (0.1-0.2ug/kg/min) for maintenance.
15966889|NCT03135795|Drug|Parecoxib|Parecoxib 40mg was given single intravenously before incision.
15966890|NCT03135782|Other|Communication Skills Training|Undergo motivational interviewing training
15966891|NCT03135782|Other|Medical Chart Review|Undergo medical chart review
15966817|NCT03136211|Behavioral|EIRA intervention|Individual intervention has an average intensity between 2 and 3 visits; if necessary, professionals have the freedom to make a greater number of visits. Group intervention is carried out through health education workshops. These workshops take place 15-20 days after initiating the individual intervention and they are conducted by primary care providers in the health center. A group of 12-15 people attend in each workshop. Community intervention focuses mainly on the social prescription of resources and activities that are carried out in the community where the participant person resides. In addition the intervention has the support of information and communication technologies, such as a web addressed to the participant, a mobile app or the sending personalized text messages.
15966818|NCT03136198|Other|LUS-guided strategy-of-care|"For patients randomized to the strategy-of-care arm, the LUS guided protocol will be initiated and continued until there is a decrease in B-lines to ≤ 15 or 6 hours of care has been delivered, whichever comes first.
~Treatment protocol:
~IV furosemide (unless already given): 2x single oral dose if on chronic therapy or 20-40 mg if diuretic naive.
~Optional therapies: non-invasive ventilation, vasodilators (SL, topical, or IV)
~Reassessment every 2 hours"
15966819|NCT03136198|Other|Usual Care|Patients will receive usual AHF care
15966820|NCT03136198|Drug|Intravenous Loop Diuretic|IV loop diuretic
15966821|NCT03136198|Drug|Vasodilator|IV, topical, or SL Vasodilator
15966822|NCT03136198|Device|Non invasive Ventilation (NIV)|Face, mouth, or nasal mask applied to provide positive pressure ventilation
15966823|NCT03136185|Drug|IMG-7289|Differentiation therapy
15966824|NCT03136172|Device|NIRS (near Infra-red spectroscopy)|"NIRS, INVOS 5100 cerebral/somatic oximeter monitor (Somanetics Corp, Troy, Michigan, USA)
~Radical-7 pulse oximeter (Masimo Corp, Irvine, CA, USA)
~Echocardiography (Phillips HD 15 Ultrasound system, CA, USA)"
15966825|NCT03136159|Device|Silver-impregnated antimicrobial dressing|All participants will receive an adherent soft silicone silver impregnated anti-microbial occlusive foam dressing after cesarean section. The dressing will stay on for up to seven days.
15966826|NCT03136146|Drug|Bortezomib|Given SC
15966827|NCT03136146|Drug|Clofarabine|Given IV
15966828|NCT03136146|Drug|Cyclophosphamide|Given IV
15966829|NCT03136146|Drug|Dexamethasone|Given IV or PO
15966830|NCT03136146|Drug|Etoposide|Given IV
15966831|NCT03136146|Biological|Ofatumumab|Given IV
15966832|NCT03136146|Biological|Pegfilgrastim|Given SC
15966833|NCT03136146|Biological|Rituximab|Given IV
15966834|NCT03136146|Drug|Vincristine Sulfate Liposome|Given IV
15966835|NCT03136133|Dietary Supplement|Active protein drink|Fish protein from cod to be used for man after Heavy excercise to restitute
15966836|NCT03136120|Drug|Ipratropium Bromide|Single dose of 500 mcg Ipratropium nebulizer solution will be administered to all subjects via inhalation route using nebulizer for 10 minutes. Ipratropium bromide is a clear, colorless nebulizer solution available in white plastic ampoules.
15966837|NCT03136120|Procedure|Flexible Bronchoscopy/Biopsy|After biopsy samples required for diagnosis have been collected, additional one to two TBCB samples will be taken for this study. 3-5 endobronchial biopsy samples will be taken from up to 5 subjects to compare drug distribution in proximal and distal lung.
15966838|NCT03136107|Other|Physiogel Daily Defence Protective Day Cream Light|Investigator controlled, topical application to the epidermis at a dose of 2 milligrams per square centimeter (mg/cm2). Single application.
15966839|NCT03136107|Other|ISO 24444:2010 P3 Standard Sunscreen|Investigator controlled, topical application to the epidermis at a dose of 2 mg/cm2. Single application.
15966840|NCT03136094|Behavioral|SBIRT+12|The standard SBIRT model is augmented by a 12 month period following identification of suicide risk during which participants received caring text messages adapted from empirically-based, effective interventions for suicide prevention among American Indian and Alaska Native young adults.
15966841|NCT03136094|Behavioral|SBIRT+Usual Care|Patients receive usual SBIRT care
15966842|NCT03136081|Diagnostic Test|Candidiasis infection occurence|Candidiasis infection occurence
15966843|NCT03136068|Drug|Digoxin|Trans-abdominal injection
15966844|NCT03136068|Drug|Placebo|Trans-abdominal injection
15966845|NCT03136055|Drug|Pembrolizumab|200 mg every 3 weeks via IV infusion.
15966846|NCT03136055|Drug|Irinotecan|"For patients in part B receiving pembrolizumab and chemotherapy with irinotecan. The starting dose for the safety lead-in is 125 mg/m2 irinotecan via IV infusion in a 2 weeks on, 1 week off format over 3 week cycles.
~If the initial dose is not tolerated, the dose level will be decreased to 100 mg/m2."
15966847|NCT03136055|Drug|Paclitaxel|For patients in part B receiving pembrolizumab and chemotherapy with paclitaxel. Patients will receive 80 mg/m2 of paclitaxel via IV infusion every week, with treatment breaks as needed.
15966848|NCT03136042|Other|physiotherapy techniques|oscillating positive expiratory pressure during nonstop 5 minutes. After that more five minutes to a forced expiratory technique
15966849|NCT03136042|Other|hypertonic saline 3%|four nebulizations with 3% hypertonic saline, the aerosol was generated by an ultrasonic nebulizer
15966850|NCT03136042|Other|saline + physiotherapy maneuvers|sputum induction by hypertonic saline at 3% for seven minutes. And more five minutes under physiotherapists maneuvers
15966851|NCT03136029|Dietary Supplement|Antioxidant|Daily consumption of over-the-counter vitamins (600mg alpha lipoic acid, 1000mg vitamin c, 600IU vitamin E)
15966852|NCT03136029|Dietary Supplement|Tetrahydrobiopterin (BH4)|Daily consumption of BH4 (10mg/kg)
15966853|NCT03136029|Other|Exercise training|Aerobic exercise training program (3x/week for 8 weeks, 1 hour per session)
15966854|NCT03136016|Behavioral|educational activities|Group 2 will receive classroom-based educational activities based on an earlier study, called PAPPAS, which was developed in the same city and constituted a school-based intervention with the objective of reducing the consumption of sweetened beverages and biscuits and increase the consumption of fruits, vegetables and beans
15966855|NCT03136016|Behavioral|nudging|In group 3, changes in the environment will be included that will facilitate both physical activity and healthy food choices
15966856|NCT03136016|Behavioral|nudging + educational activities|Group 4 will receive both interventions
15966857|NCT03136003|Drug|DDAVP|The participant will take either 1 or 2 nasal sprays of IN DDAVP (known as Octostim® in Canada). After receiving IN DDAVP, the participant will rest for 30 minutes.
15966892|NCT03135782|Other|Questionnaire Administration|Ancillary studies
15966858|NCT03136003|Behavioral|Exercise|The participant will exercise on a stationary cycle-ergometer using the previously-validated, progressively-incremental Godfrey protocol. Per the Godfrey protocol, the participant starts cycling on the calibrated cycle-ergometer with an initial exercise load dependent on their height. The workload is increased every minute in standard increments also based on the participant's height. All participants will exercise until they complete 3-minutes of cycling at 85% of their maximum predicted heart rate or exhaustion (whichever is first). Upon completion of planned exercise, work load is decreased to zero watts and participants will continue cycling at this cool-down rate for an additional 3-minutes, before getting off the ergometer.
15966859|NCT03135990|Behavioral|Cognitive Behavioral Therapy with Virtual Reality Technology|Cognitive Behavioral Therapy Intervention: This manualized intervention is a modified version of the Unified Protocol for Emotional Disorders in Youth, a modular Cognitive Behavioral Therapy protocol for anxiety disorders and depression with demonstrated efficacy in youth. The 10-session intervention includes psychoeducation about anxiety disorders and their treatment (1 session), emotion awareness and regulation (2 sessions), exposure therapy using virtual reality environments (6 sessions), and review and relapse prevention (1 session). All treatment sessions will be videotaped to ensure fidelity to treatment manual and modules.
15966860|NCT03135977|Drug|Apatinib, Etoposide|Patients receive etoposide 50mg from day 1 to day 14 and apatinib 250mg/d from day 1 to day 21, repeated every 21 days until progressive Disease(PD) .
15966861|NCT03135964|Device|filler dressing of NPWT|a dressing or filler material is used to fit to the contours of a wound (which is covered with a non-adherent dressing film) .
15966862|NCT03135951|Drug|SPI-2012|Supplied in prefilled, single-use syringes for subcutaneous injection and administered on Day 2 of each cycle.
15966863|NCT03135938|Procedure|Grading Inferior Oblique Anterior Transposition surgery|in the grading group, IO muscle of the eye with more severe DVD will be sutured at the level of IR insertion and IO muscle of the eye with lower magnitude of DVD will be sutured 2mm posterior to the sclera to consider the preoperative DVD difference between the two eyes.
15966864|NCT03135938|Procedure|Classic Inferior Oblique Anterior Transposition surgery|in the classic group, IO muscle will be sutured to the sclera at the level of inferior rectus (IR) insertion at its temporal border, without considering the asymmetric DVD between the two eyes
15966865|NCT03135925|Other|Supervised Exercise Program|Participants will be invited to attend a weekly supervised exercise program over six weeks, in the time before their bone marrow transplantation
15966866|NCT03135912|Drug|Experimental Drug SESC 01|Topical experimental treatment comprising a combination of approved topical therapies and a new dosage method.
15966867|NCT03135912|Drug|Placebo|Dosage method of SESC 01, without active ingredients.
15966868|NCT03135912|Drug|Terbinafine Hydrochloride|Topical terbinafine hydrochloride cream.
15966869|NCT03135899|Drug|BI 443651|Three doses, each 12 hours apart
15966870|NCT03135899|Drug|Placebo|Three doses, each 12 hours apart
15966871|NCT03135886|Other|Information Control|The OTPs assigned to this group will be provided access to the NIDA/SAMHSA Blending Initiative product for HIV rapid testing. Resources generated from the HIV rapid testing Blending Initiative product include a fact sheet, resource guide, marketing materials, and an Excel-based budgeting tool. In addition to the HIV-specific materials, the website provides opportunities for training, self-study progress, workshop, and distance learning. OTPs also will receive a link to the Anti-Retroviral Treatment and Access to Services (ARTAS) intervention training website which provides information and training courses. Sites also will receive a hard (or electronic) copy of the ARTAS implementation manual and information about the provision of HIV testing, linkage to care and PrEP.
15966872|NCT03135886|Other|HIV and HCV Testing Practice Coaching Intervention|The practice coaches (PCs) will work with the program team a) to establish capabilities, reimbursement systems and/or partnerships necessary to support HIV and HCV testing and evidence--based linkage to care and b) to reduce barriers (e.g., staffing, training) to the implementation and sustained provision of HIV and HCV testing. Also, due to the expense of HCV treatment, and potentially more complicated mechanisms for linking HCV-positive patients to further evaluation and care which may take more time than anticipated, PCs will provide OTPs with basic education and motivation about the importance of HCV testing for reasons other than immediate curative treatment. Information on PrEP also will be provided. The intervention will occur over approximately 29 weeks (or 6 months).
15966873|NCT03135886|Other|HIV Testing Practice Coaching Intervention|The practice coaches (PCs) will work with the programs a) to establish capabilities, reimbursement systems and/or partnerships necessary to support HIV testing and evidence-based linkage to care and b) to reduce barriers (e.g., staffing, training) to the implementation and sustained provision of HIV testing. Information on Pre-Exposure Prophylaxis (PrEP) also will be provided. The intervention will occur over approximately 29 weeks (or 6 months) consisting of four distinct evidence-based phases designed to establish competency in the implementation of organizational change towards establishing HIV testing outcomes among OTP clientele.
15966874|NCT03135873|Dietary Supplement|Mastiha|Mastiha is a natural product of Greece and has a license of manufactures Foods for Particular Nutritional Uses and of National Organization of Medicines (EOF).
15966875|NCT03135873|Dietary Supplement|Placebo|Placebo is designed to have identical characteristics with verum.
15966876|NCT03135860|Drug|Inhaled Nitric Oxide 30mcg/kg IBW/hr|Inhaled Nitric Oxide 30 mcg/kg IBW/hr will be administered through the INOPulse Device open label for 4 weeks
15966877|NCT03135847|Device|Tactor|The tactor is a small robot providing touch and vibration.
15966882|NCT03135821|Diagnostic Test|TCM|
15966883|NCT03135795|Drug|Sufentanil|Patients received intravenous sufentanil 0.5μg/kg for induction,and received PCA after surgery with sufentanil 1ug/ml using a controlled infusion pump, which was programmed to use a loading dose of 2ml, background infusion at 2m/h, PCA dose of 1ml, lockout time of 10min, and maximal dose of 12ml within 1 hour period.
15966884|NCT03135795|Drug|dexmedetomidine|Patients received intravenous dexmedetomidine 1μg/Kg for induction.
15966885|NCT03135795|Drug|propofol|Patients received intravenous propofol 2mg/Kg for induction, and received intavenous pump of propofol (0.3-0.6mg/kg/h) for maintenance.
15966893|NCT03135782|Other|Tobacco Cessation Counseling|Attend phone or in-person motivational interviewing coaching sessions
15966894|NCT03135769|Drug|Avelumab administration at 10mg/kg|Avelumab administration at 10 mg/kg as a 1 hour IV infusion once every 14 days during 6 months (maximum).
15966895|NCT03135743|Other|Show an increase in incidence of cancers in patients with synchronous lymphoma|Show an increase in incidence of cancers in patients with synchronous lymphoma
15966896|NCT03135730|Genetic|ROHHAD|Suspected and Confirmed ROHHAD cases
15966897|NCT03135717|Dietary Supplement|Nutritional care|"Diagnosis of protein energy wasting : anthropometry, calculation of the nutrient intakes, evaluation of appetite, evaluation of gastrointestinal syndromes, hand grip test and bioimpedancemetry
~Treatment of protein energy wasting : estimation of nutritional requirements, prescription of oral nutritional supplement or artificial nutrition, physical rehabilitation
~Multidisciplinary approach (nephrologists, dieticians, physiotherapists, nurses)
~Evaluation of the nutritional treatment (plasma albumin and prealbumin, weight evolution, muscle strength and body composition)"
15966898|NCT03135704|Device|"Re Spine"|A new mattress design made of special materials and built in a specially shaped structure that allows the brain to relax the body and dissipate tension accumulated on the lumbar spine.
15966899|NCT03135704|Other|Physiotherapy|Usual protocol for treatment of low back pain
15966900|NCT03135665|Device|Ultrasound|"Scolioscan, the ultrasound system reported to be reliable and valid for spinal deformity assessment, will be used. The system composes of an ultrasound scanner with a linear probe of 100 mm in width and frequency range of 4-10MHz, a frame structure and a spatial sensor which is attached to the ultrasound probe for spatial data capture. Daily calibration will be performed using a phantom to assure accuracy of spine image formation and subsequent angle measurement.
~Subjects will stand on the Scolioscan platform with a standardized posture kept stable with pegs throughout the scanning process.. After adjusting the ultrasound scanner setting, the probe will be steered from L5 to T1 spinous process for scanning.
~SPA will be used to determine the ultrasound-based Referral Status through predicting whether the Cobb angle is beyond the referral threshold of ≥20° or not. There are two values for the Referral Status: either for specialist referral or not for specialist referral."
15966901|NCT03135652|Radiation|adjuvant SBRT|adjuvant SBRT of liver lesions
15966902|NCT03135652|Drug|Chemotherapy|mFolfox6/ CAPEOX/ Folfiri±cetuximab or bevacizumab, 2 months for neoadjuvant treatment and 4 months for adjuvant treatment
15966903|NCT03135639|Other|NeuroConn Plus Stimulator tACS|Transcranial alternating current stimulation (tACS) is a novel, noninvasive brain stimulation approach in which weak electric currents are applied to the scalp. The electric currents that are applied to the scalp are in a sine-wave pattern.
15966904|NCT03135639|Other|NeuroConn Plus Stimulator Sham|For sham stimulation, the participant receives up to 1 minute of tACS stimulation until the stimulation fades. This mimics the same skin sensations that a participant would experience during a tACS session.
15966905|NCT03135626|Drug|Biodentine|
15966906|NCT03135626|Drug|ProRoot (Aggregate)|
15966907|NCT03135626|Drug|MTA Plus|
15966908|NCT03135626|Drug|Ferric Sulfate 20 % Dental Gel|
15966909|NCT03135613|Procedure|Procedure|Once participants are eligible, they will undergo the experimental procedure. Before data collection, they will walk on a treadmill in barefoot for ten minutes to adapt the condition. The gait analysis system will collect the data while they walk on the treadmill in barefoot at self-selected gait speed.
15966910|NCT03135600|Procedure|Procedure|Once participants are eligible, they will undergo the experimental procedure. Before data collection, they will walk on a treadmill in barefoot for ten minutes to adapt the condition. The a gait analysis system will collect the data while they walk/run on the treadmill in barefoot at 4/6km/h.
15966911|NCT03135587|Procedure|Loading level|Once participants are eligible, they will undergo the experimental procedure. Before data collection, they will walk on a treadmill in barefoot for ten minutes to adapt the condition. The gait analysis system will collect the data while they walk on the treadmill in barefoot with selected weight loading suit at 3.0km/h.
15966912|NCT03135574|Diagnostic Test|MRI T2 sequence of the oculomotor tract|Patients with ophthalmoplegia will benefit from an MRI T2 sequence of the oculomotor tract (additional time of 4 minutes).
15966913|NCT03135561|Behavioral|pedometer-plus-email|After randomisation, participants will receive a pedometer and will be instructed to wear the pedometer daily for the next four months, check the step count every evening and gradually increase their daily number of steps to at least 10,000. They will also be required to upload data to a website at least once a week. During the intervention period, patients will receive 8 counselling emails based on behavioural techniques.
15966914|NCT03135561|Behavioral|pedometer-only|After randomisation, participants will receive a pedometer and will be instructed to wear the pedometer daily for the next four months, check the step count every evening and gradually increase their daily number of steps to at least 10,000. They will also be required to upload data to a website at least once a week. There will be no further interaction during the intervention period unless they fail to upload data, in which case they will be offered technical support.
15966915|NCT03135548|Drug|Spesolimab (low dose)|12 weeks treatment
15966916|NCT03135548|Drug|Placebo|12 weeks treatment
15966917|NCT03135548|Drug|Spesolimab (high dose)|12 weeks treatment
15966919|NCT03135522|Drug|Zinc Acetate 50 Mg Oral Capsule|"Day 0 (randomization) to day 3 Zinc acetate 50 mg per day (one capsule)
~Day 4 to day 7 If well tolerated: Zinc acetate 100 mg per day (two capsules)
~Day 8 to V5 (6 weeks) If well tolerated: Zinc acetate 150 mg per day (three capsules)"
15966920|NCT03135522|Drug|Placebo oral capsule|"Day 0 (randomization) to day 3 Placebo (one capsule per day)
~Day 4 to day 7 If well tolerated: placebo (two capsules per day)
~Day 8 to V5 (6 weeks) If well tolerated: placebo (three capsules per day)"
15966921|NCT03135509|Drug|CC-220|CC-220 gelatin capsules
15966922|NCT03135496|Other|Study of endothelial function biological markers|Study of endothelial function biological markers
15966923|NCT03135457|Procedure|Autologous RBC transfusion|Autologous RBC transfusion 300ml 10 ml/min
15966924|NCT03135457|Procedure|Saline transfusion|Saline transfusion 300ml 10ml/min
15966925|NCT03135444|Behavioral|PSA TOOL|Providers will be given the initial PSA TOOL and will be asked to give their feedback to revise the tool.
15966926|NCT03135444|Behavioral|Revised PSA TOOL|Patients will be given the revised PSA TOOL, after providers have given their initial feedback.
15966927|NCT03135444|Behavioral|Informal Interview|Both patients and providers will have informal interviews with the study team to get feedback on the survey taking process.
15966928|NCT03135431|Procedure|Bilateral Salpingectomy|Surgical removal of entire fallopian tubes
15966929|NCT03135431|Procedure|Bilateral Tubal Ligation|Surgical tying, cutting, or removal of a portion of the fallopian tubes
15966930|NCT03135418|Device|Intervention|"Patients will use virtual reality d4evice to play task oriented games like bowling, arrow shooting and home activity simulations which focuses upper extremity abduction, flexion and rotation movements. Each session will be a total of 45 minutes divided to 3 15 minute games. Sessions will held for 6 weeks each monday, wednesday and friday at same time for each patient.
~In addition to the virtual reality treatment program conventional rehabilitation therapies including neurodevelopmental facilitation techniques, physiotherapy, and occupational therapy and, where necessary, speech therapy will be applied according to the needs of the patient."
15966931|NCT03135418|Device|Control|The control group will be included in the virtual reality program only focusing on visual scenes without upper extremity interaction. Bobath therapy, walking exercises, upper extremity active exercises, proprioceptive neuromuscular facial techniques will be applied to the control group for 6 weeks.
15966932|NCT03135405|Behavioral|Automated messages|Automated motivational messages and visit and medication reminders will be provided via interactive voice response calls or text messages.
15966933|NCT03135405|Behavioral|Home BP monitors|Participants will have the option of receiving home blood pressure monitors.
15966934|NCT03135405|Behavioral|Care partner reminders|Participants will have the option of designating a care partner who will also receive automated reminder calls or text messages.
15966935|NCT03135392|Procedure|Breast Reconstruction with Artificial Implant|Patients undergo unilateral or bilateral reconstruction of breasts after nipple sparing mastectomy. Breasts are reconstructed with artificial implants
15966936|NCT03135392|Procedure|Autologous Breast Reconstruction|Patients undergo unilateral or bilateral reconstruction of breasts after nipple sparing mastectomy. Breasts are reconstructed with the patient's own tissue
15966937|NCT03135392|Procedure|Neurotization|Nerve will be reconstructed during autologous breast tissue reconstruction
15966938|NCT03135379|Device|Heated ultrasound gel|"Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) set to medium setting (102 degree fahrenheit)."
15966939|NCT03135379|Device|Room temperature gel|Gel stored in Thermasonic Gel Warmer (Model 82-03 LED, 120V) turned off.
15966940|NCT03135366|Behavioral|Keheala|
15966941|NCT03135366|Other|Standard of Care|Patients receive medication for a week or two weeks at a time. They are assigned a friend or family member 'supporter' to verify the patient's at-home treatment and instructed to return to the clinic with the patient during medication refills.
15966942|NCT03135353|Device|3D saline infusion sonohysterography|instillation of saline in the uterine cavity using pediatric foley's catheter, then performing 3D ultrasound scan of the uterus and adenexae
15966943|NCT03135353|Device|Office Hysteroscopy|an outpatient procedure done to assess the uterine cavity using the office hysteroscopy
15966944|NCT03135340|Procedure|WALANT|These patients will receive local anesthetic for flexor tendon repair injected directly into the operative site on the hand. The local anesthetic used 1% lidocaine with 1:100,000 epinephrine.
15966945|NCT03135340|Procedure|General/regional anesthesia|These patients will receive general/regional anesthesia for flexor tendon repair. This is ropivacaine 0.5% injected by an anesthetist under image-guidance in the axillary region of the arm. If the regional anesthesia is not functioning at the time of OR, this is converted to a general anesthetic as per standard protocol.
15966946|NCT03135340|Drug|WALANT Injection|1% lidocaine with 1:100,000 epinephrine injected directly into operative site. The typical quantity is 5-10cc aliquots.
15966947|NCT03135340|Drug|Regional Anesthetic Injection|0.5% ropivacaine injected under ultrasound guidance into the axilla. The typical quantity is 30-40cc aliquots.
15966948|NCT03135327|Dietary Supplement|Ocufolin|Ocufolin medical food capsules will be taken once a day by mouth each morning with a meal for the first week, two capsules orally each morning with a meal for the second week and three capsules orally each morning with a meal for the rest of the 6 months study duration.
15966949|NCT03135314|Dietary Supplement|cocoa flavanol|7 days intake of cocoa flavanol supplement (naturex)
15966950|NCT03135314|Dietary Supplement|placebo|7 days of placebo intake
15966951|NCT03135301|Drug|letrozole plus metformin|letrozole 5 milligram tablets plus metformin 850 milligram tablets
15966952|NCT03135301|Drug|letrozole|letrozole 5 milligram tablets
15966953|NCT03135288|Device|Cell-phone|a reminder of their postpartum family planning visit 5 weeks after the delivery (one week before the scheduled visit) and a phone call 48 hours before the scheduled visit. They will also receive two follow-up phone calls to answer any questions and to remind them with the follow-up visits after insertion. Woman will be given a referral card to the outpatients' family planning clinic denoting her study group and serial number and with a specific date for postpartum family planning visits.
15966954|NCT03135275|Procedure|Staged complete PCI|During the index procedure, patients will have treated with primary PCI the culprit lesion only. Patients will be hospitalized again after 19-45 days to undergo PCI of all the other significant coronary lesions. All the revascularizations will be performed with Synergy™ stent.
15966955|NCT03135275|Procedure|Immediate complete PCI|During the index procedure, patients will have treated with primary PCI the culprit lesion, as well as all the other significant coronary lesions. All the revascularizations will be performed with Synergy™ stent.
15966956|NCT03135275|Device|Synergy™ stent|Bioabsorbable Polymer Drug-Eluting Stent
15966957|NCT03135262|Drug|Idasanutlin|Induction Treatment: Idasanutlin tablets will be administered orally once daily at escalated doses (starting dose 100 milligrams [mg], maximum 600 mg). Post-Induction Treatment: The dose and regimen will be determined by the Sponsor after review of all relevant data. The dose for maintenance/consolidation will not exceed the dose the participant received during induction.
15966958|NCT03135262|Drug|Obinutuzumab|Participants will receive a fixed dose of obinutuzumab, 1000 mg by intravenous (IV) infusion on Days 1, 8 and 15 of Cycle 1 and on Day 1 of each subsequent cycle (Cycles 2 to 6) (each cycle = 28 days) during induction treatment, and on Day 1 of every other month during maintenance treatment (eligible participants with FL only) or during consolidation treatment (eligible participants with DLBCL only).
15966959|NCT03135262|Drug|Venetoclax|Induction Treatment: Venetoclax tablets will be administered orally once daily at escalated doses (starting dose 200 mg, maximum 800 mg). Post-Induction Treatment: The dose and regimen will be determined by the Sponsor after review of all relevant data. The dose for maintenance/consolidation will not exceed the dose the participant received during induction.
15966960|NCT03135262|Drug|Rituximab|Rituximab will be administered by IV infusion at a dose of 375 milligrams per square meter (mg/m^2) on Day 1 of Cycles 1-6 during induction treatment and on Day 1 of every other month during consolidation treatment.
15966961|NCT03135249|Drug|Alemtuzumab|Alemtuzumab is a humanized monoclonal therapeutic antibody that rapidly depletes cluster of differentiation 52 (CD52)+ cells.
15966962|NCT03135236|Behavioral|Parent training|Participants will attend 3 trainings. There will be a pre-test before training 1 and an initial post-test after training 3. There will be a final post-test 1 month after the final training.
15966963|NCT03135223|Behavioral|Co-created intervention to promote physical activity|A working group of girls and researcher co-created a school-specific intervention to promote physical activity
15966964|NCT03135210|Other|Open-Chain Leg Exercise|Individuals in the open-chain group will progress through standard mobility progression.
15966965|NCT03135210|Device|Closed-Chain Leg Exercise|Individuals in the closed-chain group will progress through standard mobility exercises with the addition of closed-chain leg exercises using the MOVEO platform.
15966966|NCT03135184|Device|HDL Therapeutics PDS-2 System|Delipidation of plasma HDL to reduce coronary atheroma
15966967|NCT03135171|Drug|Trastuzumab|All dose levels will receive 8 mg/kg loading dose for cycle 1, followed by 6 mg/kg in subsequent cycles, every 3 weeks.
15966968|NCT03135171|Drug|Pertuzumab|Dose Levels two and three will receive 840 mg loading dose for cycle 1, followed by 420 mg in subsequent cycles, every 3 weeks.
15966969|NCT03135171|Drug|Tocilizumab|Tocilizumab 4-8 mg/kg, administered intravenously every three weeks
15966970|NCT03135158|Other|Exposure to vaginal delivery|Women who have vaginal births are observed for a minimum of 1 hour postpartum
15966971|NCT03135145|Device|Lite Run Gait Trainer|"Lite Run is a new system for the treatment of patients with gait and balance difficulties that uses differential air pressure inside a lower body suit to reduce up to 50 percent of a patient's body weight. The suit is similar to a pair of pants in appearance and is as easy to don and doff as a pair of pants. The suit uses technology like astronaut spacesuits to achieve comfort and flexibility while providing a unique unweighting effect that facilitates patient ambulation from sitting through taking steps. The suit is used in conjunction with the Lite Run Gait Trainer, which provides air pressure to the suit and support for the patient."
15966972|NCT03135145|Other|Usual Treatments|The usual clinical treatments (standard of care treatments) will be used to assist patients in weightbearing and walking.
15966973|NCT03135132|Behavioral|Control group|Recommend to consume usual diet during 12-week study period
15966974|NCT03135132|Behavioral|LCD group|Recommended to reduce calorie intake (a 300 kcal/day); educated to take out 1/3 of a bowl of rice from per meal a day for an easier application of 100kcal deficits, thereby reducing a 300kcal/3 meal/day
15966975|NCT03135119|Behavioral|TF-CBT|TF-CBT is typically described as including 3 phases, each focusing on a common goal and encompassing a third of treatment (4 sessions). The first phase focuses on skills-building and includes psychoeducation, parenting skills training, relaxation skills training, affect modulation skills training, and cognitive coping skills training. The second phase involves focused gradual exposure activities, including construction of a narrative account of the child's maltreatment experiences and cognitive processing of maladaptive thoughts. The third phase emphasizes the child's mastery over environmental reminders of the maltreatment and includes sharing the trauma narrative with the caregiver, in vivo exposure to physical stimuli, and enhancing future development.
15966976|NCT03135119|Behavioral|TF-CBT+AAT|TF-CBT, as described in the other arm, with animal-assisted therapy as an adjunct intervention. During the administration of TF-CBT, a certified service dog will be in the room and the participant may elect to interact with the dog as various points throughout the sessions.
15966977|NCT03135106|Drug|Erdafitinib|A single 4-mg of erdafitinib tablet will be administered on Day 1 in Treatment A and on Day 5 in Treatment B and C.
15966978|NCT03135106|Drug|Fluconazole|A 400-mg fluconazole orally (4*100 mg capsules) will be administered from Day 1 to Day 11.
15966979|NCT03135106|Drug|Itraconazole|A 200-mg itraconazole orally (2*100 mg capsules) will be administered from Day 1 to Day 11.
15966980|NCT03135093|Other|No intervention|No Intervention
15966981|NCT03135080|Other|Long-Term HEAD START Training|The Human Eyelid Analogue Device for Surgical Training And skill Reinforcement in Trachoma (HEAD START) is a surgical simulation device used to bridge the gap between classroom and live-surgery training specifically for trichiasis surgery. Long-term HEAD START practice will involve the following components, after completion of standard training (as described in the standard of care arm). Each week the participant will complete 2 surgeries on the HEAD START device. Monthly, the participant will send the accumulated cartridges to Addis Ababa for review by a senior trichiasis surgery trainer. The trainer will evaluate the cartridges and then will discuss his impression of the surgeries with the participant during a regular monthly call and note the findings. Practice will continue for 4-6 months, depending on the length of the rainy season and time of enrollment. At the end of the rainy season, an external examiner will evaluate the first 2 surgeries that the participant completes.
15966982|NCT03135080|Other|Standard of Care|All participants will receive trichiasis surgery training following Orbis' standard training approach, with the inclusion of HEAD START training between classroom and live surgery training. At the end of the surgical training session, an independent examiner will evaluate all trainees using the World Health Organization's Final Assessment of Surgeons form, as part of standard practice. The examiner also will complete a standard questionnaire focusing on the specific skill level achieved for each of the critical aspects of TT surgery. This form will be completed for all trainees undergoing training this spring, regardless of whether they are part of the long-term HEAD START assessment program.
15966983|NCT03135067|Behavioral|Provision of multiple self-tests|Participants will be given multiple Oraquick Advance HIV-1/2 test kits for testing themselves more frequently and for offering to selected sexual partners. The self-test kits will be given to participants on a monthly basis as needed. The intervention is designed to facilitate partner and couples testing, with resulting reduction in risky sexual behavior and HIV incidence among participants.
15966984|NCT03135054|Drug|Quizartinib|Quizartinib is an oral FLT3 receptor tyrosine kinase inhibitor
15966985|NCT03135054|Drug|Omacetaxine Mepesuccinate Injection|Omacetaxine Mepesuccinate is a pharmaceutical drug substance that is indicated for treatment of chronic myeloid leukemia (CML)
15966986|NCT03135041|Dietary Supplement|Fiber-containing dietary supplement|Effects of fiber-containing dietary supplement on weight loss during energy restriction
15966987|NCT03135041|Dietary Supplement|Placebo|Effects of placebo supplement on weight loss during energy restriction
15966988|NCT03135028|Drug|Entospletinib|400 mg (2 × 200 mg tablets) orally twice daily
15966989|NCT03135028|Drug|Daunorubicin|60 mg/m^2 administered intravenously daily on Days 1 to 3 of each 28-day induction cycle
15966990|NCT03135028|Drug|Cytarabine|"100 mg/m^2 intravenous administration twice daily on Days 1 to 7 of each 28-day induction cycle
~Hi-DAC: 3 g/m^2 IV administration twice daily on days 1, 3, and 5 (≤ 60 years of age) or 1 g/m^2 IV administration once daily on Days 1 to 5 (> 60 years of age) of each 28-day post-remission cycle"
15966991|NCT03135015|Other|Placebo capsules|250ml water with 16 x 250mg placebo capsules
15966992|NCT03135015|Other|2g capsules|250ml water with 8 x 250mg capsules containing Axulin powder plus 8 x 250mg placebo capsules
15966993|NCT03135015|Other|4g capsules|250ml water with 16 x 250mg capsules containing Axulin powder
15966994|NCT03135015|Other|Water Control|250ml water
15966995|NCT03135015|Other|2g tablets|250ml water with 2 x 1g tablets containing Axulin powder
15966996|NCT03135015|Other|4g tablets|250ml water with 4 x 1g tablets containing Axulin powder
15966997|NCT03135002|Other|Other|
15966998|NCT03134989|Device|Cochlear implant|Study involves measuring using Electrocochleography to measure the CM response in patients undergoing cochlear implant surgery
15966999|NCT03134976|Drug|Levothyroxine|Immediately post-operatively, all patients undergoing laryngectomy will be started on established weight-based dosing of levothyroxine administered intravenously due to the variable enteral absorption in post-operative patients including those on continuous tube feed regimens. Standard enteral dose is 1.6 mcg/kg/day. Eighty percent of this dose (1.3 mcg/kg/day) will be given IV to account for the increased bioavailability of IV levothyroxine compared to enteral levothyroxine. The maximum dose will be 200 mcg/day. Patients previously on levothyroxine at doses lower than the above dose will changed to the aforementioned standard dose. Patients on higher doses of levothyroxine pre-operatively will be maintained on on their current dosing.
15967000|NCT03134963|Other|Transcranial doppler ultrasonography|Measurement of cerebral blood flow whilst undertaking cognitive tasks with TCD monitoring.
15967001|NCT03134963|Other|Blood pressure monitoring|Continuous blood pressure recording
15967002|NCT03134963|Other|Heart rate monitoring|Continuous heart rate monitoring
15967003|NCT03134963|Other|End tidal CO2 monitoring|Continuous ETCO2 monitoring
15967004|NCT03134963|Other|Addenbrooke's cognitive examination|Performance of a memory test
15967005|NCT03134950|Behavioral|ADAPT|Aim to Decrease Anxiety and Pain Treatment is a tailored CBT ranging from 4 sessions (pain-focused) to 6 sessions (blend of pain and anxiety coping strategies depending on the needs of the individual patients. The first 2 sessions will be in person with a trained psychologist and the following 2-4 sessions will be web-based. Each web-based session will be followed by phone support.
15967006|NCT03134937|Device|High-Flow Heated and Humidified Oxygen Therapy (HFHHNO)|Participants will undergo one session of high-flow heated and humidified oxygen therapy (HFHHNO) (up to 60-70 litre/min). They will undergo a gastric ultrasound scan after session of HFHHNO therapy.
15967007|NCT03134924|Behavioral|Women's and Sexual Health [WASH]|The WASH was a group-based, 45-minute group session on vaginal health and healthy vaginal practices led by two trained facilitators. The sessions covered topics related to vaginal practices and the potential harm of vaginal practices.
15967008|NCT03134924|Behavioral|Enhanced Standard of Care|"The enhanced standard of care (SOC+) condition received a genital tract examination, collection of a vaginal swab with gram stain of vaginal secretions, diagnosis of BV, and medication as needed. At baseline participants received an individual education session on the risk of engaging in IVP and tips on discontinuing IVP."
15967009|NCT03134911|Drug|DOAC or VKA|6 months - 2 years
15967010|NCT03134911|Drug|VKA|6 months - 2 years
15967011|NCT03134872|Biological|SHR-1210|SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.
15967012|NCT03134872|Drug|Carboplatin|Carboplatin
15967013|NCT03134872|Drug|Pemetrexed|Pemetrexed
15967014|NCT03134859|Behavioral|Tummy Time|deliberate, supervised play time with the baby on his or her front (tummy) when he or she is awake
15967015|NCT03134846|Drug|Cetuximab-IRDye800CW|Pre-operatively administration of Cetuximab-IRDye800CW for intra operative margin assessment using a fluorescent antibody-based optical tracer
15967016|NCT03134833|Behavioral|Automated Messaging & Monitoring|"Youth will receive messages 1-5 messages per day for 24 months. Message banks of about 750 text messages (70-120/domain) will focus on the HIV Prevention Continuum, with messages dedicated to healthcare, wellness, sexual health, drug use and medication reminders (e.g., for PrEP) for MSM and non-MSM. Youth will be able to choose the time that they receive daily texts. Text timing and the frequency of texts (e.g., if the youth comes out) will be updated at 4-month intervals.
~Youth will complete weekly monitoring surveys by text message. The survey will cover seven domains related to the HIV Prevention Continuum. In case of non-response, reminder messages will be sent to the youth. After three days of non-response, a follow-telephone call will occur."
15967053|NCT03134573|Drug|Interferon beta-1b (Betaferon, BAY86-5046)|Solution for injection
15967054|NCT03134573|Device|Betaconnect auto-injector|Auto-injector for application of Betaferon solution which automatically covers injection related data
15967055|NCT03134573|Device|myBETAapp|Medical device which can be connected with Betaconnect auto-injector and displays injection related data to patients and offers tracking of patient reported data at the wellness- tracker
15967056|NCT03134560|Device|Vein Display Instrument|
15967017|NCT03134833|Behavioral|Peer Support|"Youth will be enrolled in online, private discussion groups.
~Peer Support will be offered by fellow participants and/or Youth Advisory Board members that have been trained in basic information on HIV, STI, drug use, mental health, homelessness, and stigma; using social media to create wall posts and use chat functions; and, how to initiate conversations on sensitive topics. By posting and responding to messages, Peer Supporters will encourage and broadly guide conversation related to the HIV Prevention Continuum, and other relevant topics.
~Coaches and Project Coordinators will be available to provide factual information (as needed), and remove inappropriate content."
15967018|NCT03134833|Behavioral|Coaching|Youth will have access to a dedicated Coach to assist with crisis support and problem-solving, linkage to HIV and related services (e.g., for substance use, mental health), and care coordination. Coaches will be accessible electronically (using social media, e-mail, text messaging) and by phone. In cases where virtual support has failed, Coaches will be available in-person (e.g., to accompany a participant to a doctor's appointment). We anticipate that Coaches will provide each youth with 10 hours of support, on average, per year.
15967019|NCT03134807|Other|Observation prospective|No intervention
15967020|NCT03134794|Behavioral|Educational intervention applying the traffic light system (TLS)|The TLS emerged to facilitate consumers' decisions. It has been applyied in medical decision making.
15967024|NCT03134768|Other|This is not an interventional study|This is an observational study
15967025|NCT03134755|Drug|Inhaled corticosteroid (mometasone)|The investigators are not measuring the effect of the intervention (ICS), but rather the effect of stress (which is not being intervened on), and this is thus an observational study. The ICS is given to children with asthma in whom an ICS is clinically indicated
15967026|NCT03134742|Other|Control Group|No interventions this is the control group-no additional scans
15967027|NCT03134742|Diagnostic Test|CT Scan|CT Scan of affected and contralateral limb
15967028|NCT03134742|Diagnostic Test|DEXA Scans|DEXA Scan of affected and contralateral limb
15967029|NCT03134742|Diagnostic Test|CT and DEXA Scans|CT Scan and DEXA Scan of affected and contralateral limb
15967030|NCT03134729|Drug|Ropivacaine for Serratus Plane Block (SPB)|Serratus Plane Block (SPB) injection of low concentration Ropivacaine (30 ml, 0.3%), in the plane between the External Intercostal Muscle and the Serratus Anterior Muscle.
15967031|NCT03134703|Drug|Methadone|Infants in the Methadone Treatment Group will receive the study drug, methadone, instead of morphine to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)
15967032|NCT03134703|Drug|Morphine|Infants in the Comparison Group will receive standard of care narcotic (morphine) to treat withdrawal symptoms from Neonatal Abstinence Syndrome (NAS)
15967033|NCT03134690|Procedure|delayed start|In this protocol, ovarian stimulation will be started from ninth day of menstrual cycle .
15967034|NCT03134690|Procedure|Conventional|In this protocol, ovarian stimulation will be started from the 2th or 3th day of the menstrual cycle.
15967035|NCT03134677|Drug|Bupivacaine|2 ml of hyperbaric bupivacaine (0.5%) was given intrathecally to patients in a sitting position by midline attempt between the L3 and L4 intervertebral space.ECG recordings were performed at preoperative, 5, 15, and 30 minutes after initial anesthesia and 30 minutes post-operatively.
15967036|NCT03134677|Drug|Sevoflurane|General anesthesia was maintained with 2-3% sevoflurane. ECG recordings were performed at preoperative, 5, 15, and 30 minutes after initial anesthesia and 30 minutes post-operatively.
15967037|NCT03134664|Procedure|Experimental group|Patients with femoral neck fractures are randomly assigned to undergo femoral head replacement via the SuperPATH approach in the experimental group.
15967038|NCT03134664|Procedure|Control group|Patients with femoral neck fractures are randomly assigned to undergo femoral head replacement via the conventional posterior approach in the control group.
15967039|NCT03134651|Device|Monitoring brain function|
15967040|NCT03134651|Drug|propofol|
15967041|NCT03134638|Drug|SY-1365 (Part 1)|"Two dosing schedules will be evaluated in dose escalation and a dose(s)/schedule(s) will be determined for Part 2:
~Twice weekly: SY-1365 will be administered by intravenous infusion over 1 or 2 hours twice a week for 3 weeks of each 4 week (28 day) cycle.
~Weekly: SY-1365 will be administered by intravenous infusion over 1 or 2 hours once a week for 3 weeks of each 4 week (28 day) cycle."
15967042|NCT03134638|Drug|Carboplatin|Carboplatin will be administered on Day 1 of each 3 week (21-day) cycle (Part 2 only)
15967043|NCT03134638|Drug|Fulvestrant|Fulvestrant will be administered as an intramuscular (IM) dose of 500 mg every 2 weeks for the first 3 doses on Day 1 and Day 15 of the first 28-day cycle (Cycle 1), and on Day 1 of the second 28 day cycle (Cycle 2), and monthly thereafter starting on Day 1 of Cycle 3 (Part 2 only)
15967044|NCT03134638|Drug|SY-1365 (Cohort 2)|In combination with carboplatin, SY-1365 will be administered by intravenous infusion over 1 or 2 hours for 2 weeks of each 3 week (21-day) cycle (Part 2 only)
15967045|NCT03134638|Drug|SY-1365 (Cohort 5)|In combination with fulvestrant, SY-1365 will be administered by intravenous infusion over 1 or 2 hours once a week for 3 weeks of each 4 week (28-day) cycle (Part 2 only)
15967046|NCT03134638|Drug|SY-1365 (Part 2 Single Agent)|SY-1365 will be administered by intravenous infusion over 1 or 2 hours twice a week for 3 weeks of each 4 week (28 day) cycle
15967047|NCT03134612|Drug|Ondansetron 8 mg|
15967048|NCT03134612|Drug|Lidocain 40 mg|
15967049|NCT03134599|Device|etafilcon A|contact lens
15967050|NCT03134599|Device|methafilcon A - Interozzo|contact lens
15967051|NCT03134599|Device|methafilcon A - CVI (CooperVision)|contact lens
15967052|NCT03134586|Other|Diagnostic imaging|
15967057|NCT03134547|Drug|low dose sevoflurane group|low volume volatile anesthetics (1.0%)
15967058|NCT03134547|Drug|high dose sevoflurane group|high volume volatile anesthetics (2.5%)
15967059|NCT03134534|Procedure|VATS lobectomy|a minimal invasive surgical types for NSCLC: VATS lobectomy
15967060|NCT03134534|Procedure|RATS lobectomy|a minimal invasive surgical types for NSCLC: RATS lobectomy
15967061|NCT03134508|Other|treated by antiTNFα|pregnant IBD women treated by antiTNFα
15967062|NCT03134508|Other|not treated by antiTNFα|pregnant IBD women not treated by antiTNFα
15967063|NCT03134495|Other|all children with at least one prescription of PPI|all children with at least one prescription of PPI
15967064|NCT03134495|Other|all children with no prescription of PPI|all children with no prescription of PPI
15967065|NCT03134482|Procedure|IVM|No gonadotropin is used, but hCG priming is utilized 36 hour before oocyte maturation.
15967066|NCT03134482|Procedure|Minimal stimulation IVF|IVF with minimal use of gonadotropin, i.e. 150 or less IU of recombinant FSH, followed by hCG triggering in GnRH antagonist protocol.
15967067|NCT03134469|Dietary Supplement|Probiotic supplement|Probiotic supplement
15967068|NCT03134469|Dietary Supplement|Placebo supplement|Placebo supplement
15967069|NCT03134456|Drug|Pembrolizumab Injection|Pembrolizumab according to the dosage and administration in Product Information of Keytruda in Korea (2mg/kg) until it is changed to 200mg flat dose.
15967070|NCT03134443|Drug|Andrographolide sulfonate|Routine treatment for acute tonsillitis + Xiyanping injection
15967071|NCT03134443|Drug|Andrographolide sulfonate simulation|Routine treatment for acute tonsillitis + Xiyanping injection simulation
15967072|NCT03134430|Other|Normal saline|Injection of Normal saline around peripheral nerve
15967073|NCT03134430|Other|peripheral Nerve block|Injection of local anesthetics around peripheral nerve
15967074|NCT03134417|Dietary Supplement|Vitamin D and magnesium|Daily vitamin D and magnesium supplements are given to participants daily for 12 weeks.
15967075|NCT03134417|Dietary Supplement|Vitamin D|Daily vitamin D supplements are given to participants daily for 12 weeks.
15967076|NCT03134417|Dietary Supplement|Placebo|Daily placebo are given to participants daily for 12 weeks.
15967077|NCT03134404|Other|No Intervention|No Intervention is required for this study
15967078|NCT03134391|Drug|Vapocoolant spray, EMLA|Subjects were given vapocoolant spray to reduce pain from spinal injection; subjects were given EMLA to reduce pain from spinal injection
15967079|NCT03134378|Drug|Rabeprazole Sodium 20mg|Twice daily
15967080|NCT03134378|Drug|Clarithromycin 500mg|Twice daily
15967081|NCT03134378|Drug|Amoxicillin 500 Mg|Twice daily
15967082|NCT03134365|Other|Mixed meal|Mixed meal with identical composition and physical characteristics (colour, texture, consistency, temperature) but distinctively different palatability.
15967083|NCT03134365|Other|Combined meal|Combined meal.
15967084|NCT03134352|Drug|ZL-3101|A brown ointment, 10g/tube, 0.4g herb/g ointment, Topical
15967085|NCT03134352|Drug|Placebo|A brown ointment, 10g/tube, 0.02 g herb/g ointment (5% of Fugan active ointment), Topical
15967086|NCT03134339|Drug|Nicotine saline 0.00mcg/kg/s|saline 0.00mcg/kg/s
15967087|NCT03134339|Drug|Nicotine 0.24 mcg/kg/s|nicotine 0.24 mcg/kg/s
15967088|NCT03134339|Drug|Nicotine 0.048 mcg/kg/s|nicotine 0.048 mcg/kg/s
15967089|NCT03134339|Drug|Nicotine 0.024 mcg/kg/s|nicotine 0.024 mcg/kg/s
15967090|NCT03134326|Device|R1-25 and R2-25 Pulse Oximeter Sensor|
15967091|NCT03134313|Device|Rainbow Adhesive Noninvasive R1 Pulse Oximeter Sensor|
15967092|NCT03134300|Diagnostic Test|Cytokine from blood|Blood draw- one intraoperative, one 3 weeks postoperative
15967093|NCT03134287|Procedure|two-finger method, reverse sellick's method|Subjects received nasogastric tube placement by two-finger method; Subjects received nasogastric tube placement by reverse sellick's method
15967094|NCT03134274|Device|Dip HBDA|Participant receive Dip HBDA semiquantitative urinalyiss kit to be used at home one day after routine prenatal consultation. Dip HBDA consists of a testing kit containing calibration color board, 10 parameter urine dipstick and a urine cup as well as a smartphone application. Application guides participant through the test flow. Dipstick is immersed in urine cup, placed on color board and scanned with smartphone.
15967095|NCT03134261|Diagnostic Test|WB-MRI|scanning methods
15967096|NCT03134261|Diagnostic Test|SPECT-CT|scanning methods
15967097|NCT03134261|Diagnostic Test|Cholin-PET-CT|scanning methods
15967098|NCT03134261|Diagnostic Test|PSMA-PET-CT|
15967099|NCT03134248|Device|Dailies Aquacomfort Plus Toric|daily disposable contact lens
15967100|NCT03134248|Device|1-Day Acuvue Moist for Astigmatism|daily disposable contact lens
15967101|NCT03134248|Device|MyDay Toric|daily disposable contact lens
15967102|NCT03134235|Other|Dietary Intervention|Subjects consumed a raw, vegan diet for 4-weeks with an emphasis on raw fruit and vegetable consumption.
15967103|NCT03134222|Drug|Lanraplenib|30 mg tablets administered orally once daily with or without food
15967104|NCT03134222|Drug|Filgotinib|200 mg tablets administered orally once daily with or without food
15967105|NCT03134222|Drug|Lanraplenib placebo|Tablets administered orally once daily with or without food
15967106|NCT03134222|Drug|Filgotinib placebo|Tablets administered orally once daily with or without food
15967107|NCT03134209|Device|Zipper surgical skin closure|The device acts like a scaffold to stabilize the adjacent sides of a wound in order to minimize forces that can disrupt normal healing of the skin.
15967108|NCT03134209|Other|Monocryl + Dermabond|conventional sutures and skin adhesive glue
15967109|NCT03134209|Other|Polyester mesh + Dermabond|conventional sutures and skin adhesive glue
15967110|NCT03134196|Drug|Masked Placebo|Oral Placebo
15967111|NCT03134196|Drug|Masked Oral Valacyclovir|Oral Valacyclovir 1000 mg/day
15967112|NCT03134183|Drug|Vaginal Misoprostol|Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) vaginally 1-2 hours prior and placebo (buccal mint powder) buccally 1-2 hours prior to D&E
15967113|NCT03134183|Drug|Buccal Misoprostol|Mifepristone 200mg orally 20-24 hours prior and misoprostol 400mcg (two 200mcg tablets) ground with mint into buccal powder and placebo (two lactose tablets designed to appear similar to misoprostol) vaginally 1-2 hours prior to D&E
15967114|NCT03134170|Other|Pharmacist review of therapy|Patients who are randomized to the pharmacist group will have their treatment reviewed by a pharmacist
15967115|NCT03134157|Drug|oral drug and vaginal placebo|prescription of simvastatin 40 mg orally+ vaginal placebo every day for 3 months.
15967116|NCT03134157|Drug|oral drug and oral placebo|prescription of simvastatin 40 mg orally+ oral placebo every day for 3 months.
15967117|NCT03134157|Drug|Vaginal placebo+ oral placebo|prescription of Vaginal placebo + oral placebo every day for 3 months.
15967118|NCT03134144|Device|"Exoskeleton Chairless Chair"|One solution to reduce the exposure of employees to associated risks for developing work-related musculoskeletal disorders is to use exoskeletons. Using such a device in dynamic environments has the advantage over, e.g., robotics because it does not need any programming or teaching of robots. Moreover, exoskeletons are worn at the body and do not have to overcome spatial issues. In a recent review, 26 different exoskeletons have been described of which only two were designed to support the lower body during heavy work (de Looze et al. 2015). For lower intensive work tasks, like assembly tasks in the automobile industry, no study has focused on using exoskeletons to relieve employees while performing the work standing.
15967119|NCT03134131|Drug|ONC201|ONC201 is an oral, small molecule selective antagonist of DRD2 that induces tumor cell death.
15967120|NCT03134118|Drug|Nivolumab|Patients will be centrally registered and will receive nivolumab 240 mg IV every 2 weeks
15967121|NCT03134105|Other|Monthly Feedback on activity and patient-reported angina|Providers will receive monthly updates on step count and patient reported angina for each of their patients, with data derived from a wearable fitness tracker and every other week emailed surveys
15967122|NCT03134105|Other|End-of-Study Feedback|Providers will receive an end-of-study update on step count and patient reported angina for each of their patients, with data derived from a wearable fitness tracker and every other week emailed surveys
15967123|NCT03134092|Other|Probabilistic Risk Communication Tool (PRT)|The probabilistic risk communication tool (PRT) is a visual tool that communicates risk using the previously validated Opioid Risk Tool (ORT). The ORT is designed to assess risk of opioid dependency for patients for whom an opioid pain relief prescription is being considered in outpatient settings. Patients in this arm will be given an iPad which will prompt them to take a short survey that automatically communicates their risk score. After which the iPad will show them a color coded visual thermometer that informs them of their risk of having issues related to opioids.
15967124|NCT03134092|Other|Narrative Enhanced Risk Tool (NERT)|Participants assigned to this arm will receive the PRT described above but will also be instructed to watch one or more narrative videos. This video intervention will include a brief narrative video of an individuals' cautionary tale around prolonged opioid uses. Narrative videos are developed from actual patients sharing their stories - put into a in a structured format of ~ 2-minute length and recorded.
15967125|NCT03134079|Other|apple crisp|Subjects tasted three items (apple crisp, tea and oatmeal) in a randomized sequence schedule to allow for tasting the three recipes (full sugar recipe, reduced sugar recipe and reduced sugar plus spice recipe) over three weeks. Oatmeal and tea were served together as a breakfast meal and tastings of oatmeal and tea were done over 3 weeks and tastings for apple crisp (served alone) were done over 3 different weeks. Subjects tasted one of the three recipes at each weekly seating.
15967126|NCT03134079|Other|tea|Subjects tasted three items (apple crisp, tea and oatmeal) in a randomized sequence schedule to allow for tasting the three recipes (full sugar recipe, reduced sugar recipe and reduced sugar plus spice recipe) over three weeks. Oatmeal and tea were served together as a breakfast meal and tastings of oatmeal and tea were done over 3 weeks and tastings for apple crisp (served alone) were done over 3 different weeks. Subjects tasted one of the three recipes at each weekly seating.
15967127|NCT03134079|Other|oatmeal|Subjects tasted three items (apple crisp, tea and oatmeal) in a randomized sequence schedule to allow for tasting the three recipes (full sugar recipe, reduced sugar recipe and reduced sugar plus spice recipe) over three weeks. Oatmeal and tea were served together as a breakfast meal and tastings of oatmeal and tea were done over 3 weeks and tastings for apple crisp (served alone) were done over 3 different weeks. Subjects tasted one of the three recipes at each weekly seating.
15967128|NCT03134053|Device|extracorporeal shock-wave|to treat painful and retracting scars
15967129|NCT03134053|Other|massage|to treat painful and retracting scars
15967130|NCT03134040|Behavioral|Incentives (Rebate)|
15967131|NCT03134040|Behavioral|Incentives (Donation)|
15967132|NCT03134040|Behavioral|Feedback|
15967133|NCT03134027|Procedure|Bone marrow biopsy|Subjects will undergo a bone marrow biopsy to obtain aspirate for stem cell collection.
15967134|NCT03134027|Procedure|Tumor biopsy|Subjects will undergo a tumor biopsy to obtain tissue for generation of a PDX.
15967135|NCT03134014|Dietary Supplement|Breakfast|If randomized to a breakfast consuming group, participants will be given breakfasts to consume between 6:00-8:00 am.
15967136|NCT03134001|Device|patients receiving oral analgesics via the PCoA™ Acute|PCoA™ Acute is an oral PCA device, designed to provide safe and easy-to-use pain medication at the bedside. It identifies patients by Radio Frequency Identification (RFID) technology and provides pill dispensing upon patient's request.
15967137|NCT03133988|Biological|Margetuximab|anti-HER2 monoclonal antibody
15967138|NCT03133975|Drug|Vitamin D3 (Treatment)|Single high dose vitamin D3 in treatment of dyslipedemia
15967139|NCT03133975|Other|Mixed diet of carbohydrate and protein (Control)|Mixed diet of carbohydrate and protein
15967140|NCT03133962|Other|Adult patients who are candidates for a CAP or long-term central catheter placement|Evaluate the feasibility of finding the correct positioning of the distal end of the PAC or of the long-term catheter by cardiac ultrasound in comparison with the brightness scopy, reference method.
15967141|NCT03133949|Other|Establish the clinical, biological and radiological characteristics of patients|Establish the clinical, biological and radiological characteristics of patients
15967142|NCT03133923|Biological|≥3.0 lgCCID50/mlbut <3.5lgCCID50/ml Live Attenuated Mumps Vaccine (Human Diploid Cell) in infants(8-24 months old)|≥3.0 lgCCID50/ml but <3.5lgCCID50/ml;Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in 360 infants(aged 8-24 months ) on 0 day
15967143|NCT03133923|Biological|≥4.5 lgCCID50/ml Live Attenuated Mumps Vaccine (Human Diploid Cell) in infants(8-24 months old)|≥4.5CCID50/ml;Live Attenuated Mumps (F-genotype) Vaccine (Human Diploid Cell, KMB-17) in 360 infants(aged 8-24 months ) on 0 day
15967144|NCT03133923|Biological|Measles and Mumps Combined Vaccine，Live(SIBP)( positive control)|Measles and Mumps Combined Vaccine，Live(SIBP) in 360 infants(aged 8-24 months ) on 0 day
15967145|NCT03133897|Drug|Dexamethasone|experimental group will receive 2 day treatment
15967146|NCT03133897|Drug|Prednisone|control group will receive 4 day treatment
15967147|NCT03133884|Other|acupuncture|The needles will be inserted into the acupoints and the depths will be adjusted to the standard permissible layers, then even reinforcing-reducing technique will be performed on the needles until achieving deqi sensation.The needles will be retained for 30 minutes in each session and manipulated twice every 10 minutes with intermittent stimulation. Each manipulation will last for 30 seconds.
15967148|NCT03133884|Other|superficial acupuncture|The selected acupoints will be punctured superficially by the depth of 1-3 mm, and the needles will be retained for 30 minutes without any manipulation.
15967149|NCT03133845|Procedure|Light sedation with propofol|Patients having lumbar spinal surgery and receiving spinal anesthesia will receive propofol for light sedation.
15967150|NCT03133845|Procedure|Induction with propofol|Patients having lumbar spinal surgery and receiving general anesthesia will receive propofol and their induction agent.
15967151|NCT03133845|Procedure|Maintenance anesthetic using a volatile anesthetic|Patients having lumbar spinal surgery and receiving general anesthesia will receive a volatile anesthetic for their maintenance anesthesia.
15967152|NCT03133845|Procedure|Muscle relaxant during maintenance anesthesia|Patients having lumbar spinal surgery and receiving general anesthesia with receive a muscle relaxant for muscle paralysis.
15967153|NCT03133845|Procedure|Pain control with fentanyl|Patients having lumbar spinal surgery and receiving general anesthesia will receive fentanyl for their pain during surgery.
15967154|NCT03133845|Procedure|Bispectral Index (BIS) monitoring for depth of anesthesia|All patients will be monitored with Bispectral Index (BIS) to monitor the patient's depth of anesthesia.
15967155|NCT03133845|Procedure|Spinal Anesthesia|Patients receiving spinal anesthesia will receive bupivacaine into the subarachnoid space.
15967156|NCT03133845|Procedure|Midazolam administered during spinal anesthesia|Midazolam may be administered during spinal needle insertion for patients receiving spinal anesthesia.
15967157|NCT03133845|Procedure|Cerebrospinal fluid collection|8 ml of cerebrospinal fluid may be collected prior to the administration of intrathecal administration of morphine for pain control.
15967158|NCT03133845|Procedure|Administration of intrathecal morphine|Patient may receive intrathecal morphine for post-operative pain control.
15967159|NCT03133832|Drug|Companion Tablet|Chinese-made drug for schistosomiasis treatment
15967160|NCT03133819|Device|Q-Sense_QST (TSA II)|QST will perform using the Medoc device (TSA2001/VSA3001) following previous published procedures. The measurement will perform on the thenar eminence of the dominant hand and the lateral distal aspect of the foot dorsum of the same side.
15967161|NCT03133806|Device|Ultrasept LAA Closure System|The Ultrasept Left Atrial Appendage Closure System Device is a percutaneous transcatheter device intended to prevent thrombus embolization from the left atrial appendage (LAA) in patients with non-valvular atrial fibrillation.
15967162|NCT03133793|Drug|CoQ10|Participants will take 300mg capsules two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
15967163|NCT03133793|Drug|D-Ribose Oral Powder|Participants will mix 15 grams D-Ribose powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
15967164|NCT03133793|Other|Placebo pills|Participants will take matched placebo pills that are 300mg capsules, two times daily, 1 taken in the morning and 1 taken in the evening, for up to 12 weeks.
15967165|NCT03133793|Other|Placebo powder|Participants will mix 15 grams placebo powder, mixed with non-carbonated liquid, one time per day for up to 12 weeks.
15967166|NCT03133780|Drug|Ketamine|Patient will receive IV ketamine 0.5 mg/kg diluted in normal saline to a volume of 50 ml over 10 min
15967167|NCT03133780|Drug|Midazolam|Patient will receive IV midazolam 0.03 mg/kg diluted in normal saline to a volume of 50 ml over 10 min
15967168|NCT03133767|Drug|Lactated Ringer Solution|2 liters of intravenous lactated ringers solution will be administered by peripheral IV
15967169|NCT03133767|Drug|Normal Saline 0.9% Infusion Solution Bag|2 liters of intravenous normal saline solution will be administered by peripheral IV
15967170|NCT03133754|Procedure|DP-PEEP|PEEP titration trial for the lowest DP after the alveolar recruitment maneuver
15967171|NCT03133754|Procedure|RM-5|Fixed standard PEEP after the alveolar recruitment maneuver
15967172|NCT03133741|Other|GIP-A|GIP-A (GIP receptor antagonist)
15967173|NCT03133741|Other|GLP-1 receptor antagonist Exendin[9-39]|Exendin[9-39]
15967174|NCT03133741|Other|Placebo|Saline (9mg/mL)
15967175|NCT03133741|Other|GIP-A + Exendin[9-39]|GIP receptor antagonist + GLP-1 receptor antagonist
15967176|NCT03133728|Diagnostic Test|Alere Q Testing|Infants of intervention clinics will have heelprick-obtained blood tested by standard of care method (SOC) and Alere™ q HIV-1/2 Detect Test Point of Care testing onsite (i.e. community, household, or facility level). Point-of-care (POC) testing results will be available in 52 minutes. HIV-infected infants, based on the Alere Q test result, will start ART as soon as possible and start routine SOC visits at weeks 2, 4, 8, 12, 16, 20, 24, 36, and 48 post ART-initiation. Study data will be obtained on first 4 routine visits after ART initiation (3 months). Infants will return for results of DBS-based DNA PCR testing. Positive SOC infants remain on ART/study follow-up. Negative POC test/negative SOC infants will attend only routine care visits and continue on HIV prophylaxis per national guidelines. Discordant results require DNA PCR test, with positive results continuing ART, negative results being repeated for confirmation before discontinuation.
15967177|NCT03133715|Procedure|laparoscopic repair|surgical repair of ventral hernia using laparoscopic repair
15967178|NCT03133715|Procedure|robot-assisted repair|surgical repair of ventral hernia using robot-assisted repair
15967179|NCT03133702|Other|Forensic cases|Forensic cases which were admitted to the Emergency Department
15967182|NCT03133663|Other|Electrocardiogram group|Experimental
15967183|NCT03133663|Other|Pulse oximeter and auscultation group|Control
15967279|NCT03132714|Drug|Metronidazole 400mg|Administration of Metronidazole 400mg tid for 7 days.
15967184|NCT03133650|Drug|WST 11-mediated VTP therapy|Administration of WST11 in conjunction with endoscopic illumination at 753 nm emitted by a diode laser and administered to the participant by optical fibre catheters (cylindrical light diffusers) and a standard upper GI endoscope.
15967185|NCT03133637|Drug|ceftriaxone|Eligible infants will receive ceftriaxone as standard of care for sepsis
15967186|NCT03133611|Other|Speech assessment|Each subject will undergo short non-invasive speech assessment lasting approximately 15 minutes that will be recorded using microphone.
15967187|NCT03133611|Other|Routine clinical assessment|Volunteers who enroll in the study will undergo various assessments lasting about 2 hours, including neurological examination of both motor and non-motor skills, autonomic testing and cognitive testing.
15967188|NCT03133585|Device|2 piece appliance for stomy|Use of the Flexima®/Softima® 3S during 6 months following the patient's usually frequency of appliance change
15967189|NCT03133572|Device|Supraglottic airway|Instead of using a conventional face mask to provide positive pressure ventilation during neonatal resuscitation we are using a supraglottic airway and a conventional bag.
15967190|NCT03133572|Device|Face-mask|In order to provide positive pressure ventilation during neonatal resuscitation we are using a conventional face-mask and a conventional bag.
15967191|NCT03133559|Other|Observational|We will use a deep phenotyping approach to collect multidimensional datasets from individuals infected with HIV compared to healthy controls to define circadian rhythm disruptions associated with HIV infection.
15967192|NCT03133546|Drug|Osimertinib|"Osimertinib is administered orally at 80mg once daily. Doses should be taken approximately 24 hours apart at the same time point each day. The appropriate number of osimertinib tablets will be provided to patients to be self-administered at home. AstraZeneca will supply osimertinib as tablets for oral administration.
~AstraZeneca will supply osimertinib as tablets for oral administration."
15967193|NCT03133546|Drug|Bevacizumab|Bevacizumab is administered at 15mg/kg intravenously on day 1 of every 3-week cycle. Bevacizumab for intravenous administration will be supplied by Roche.
15967194|NCT03133533|Procedure|laparoscopic repair|Surgical inguinal hernia repair using laparoscopic approach.
15967195|NCT03133533|Procedure|robot-assisted repair|Surgical inguinal hernia repair using robot-assisted approach.
15967196|NCT03133520|Device|High flow oxygen therapy|High-flow nasal oxygen [HFNO] therapy is a focus of growing attention as an alternative to standard oxygen therapy. By providing warmed and humidified gas, HFNO allows the delivery of higher flow rates [of up to 60 L/min] via nasal cannula devices, with fraction of inspired oxygen(FiO2) values of nearly 100%.
15967197|NCT03133507|Behavioral|Reapprasial Condition|Children in this condition will be instructed to think about how the procedure will help them become adjusted to cold weather.
15967198|NCT03133507|Behavioral|Reassurance Condition|Children will be reassured by the experimenter .
15967199|NCT03133507|Behavioral|Distraction Condition|Children in this condition will be instructed to focus their attention on a picture on a computer screen rather than on the pain.
15967200|NCT03133494|Other|ABG analysis|ABG analysis was performed and compared between two groups
15967201|NCT03133481|Procedure|Adductor Canal Nerve Block|Adductor Canal never technique
15967202|NCT03133481|Drug|Femoral Nerve Block|Traditional technique
15967203|NCT03133468|Drug|AJM347|Oral administration
15967204|NCT03133468|Drug|Placebo|Oral administration
15967205|NCT03133455|Other|Evaluate the link between an abstract / analytical thinking style and depressive manifestations in FM.|Evaluate the link between an abstract / analytical thinking style and depressive manifestations in FM.
15967206|NCT03133442|Device|Somnomat V4|Vestibular stimulation is provided using an innervated bed platform. This robotic device consists of a standard single bed, mounted on a moving mechanism. It was developed and produced by the ETH Zürich and approved for use in this study by Swissmedic.
15967207|NCT03133429|Device|MER|carotid artery stenting
15967208|NCT03133416|Other|PRP preparation|
15967209|NCT03133416|Device|Physiotherapy|
15967210|NCT03133416|Other|PRP and physiotherapy|
15967211|NCT03133377|Behavioral|Early activity and mobilisation|The early activity and mobilisation intervention is comprised of exercises based on a reproducible, physiological approach using both strength and functional activities
15967212|NCT03133364|Other|Sensory optimized meals|19 main meals and 12 between-meals are optimized and composed to a menu for 12 weeks.
15967213|NCT03133351|Device|PCM|A fresh whole blood sample will be tested by PCM to determine the reference range.
15967214|NCT03133338|Device|pelvic binder|The requirement of angioembolization can be predicted by the presence of intravenous contrast extravasation (ICE) on computed tomography (CT)
15967215|NCT03133325|Device|GP0045|Hyaluronic acid gel
15967216|NCT03133325|Device|Restylane Lyft Lidocaine|Hyaluronic acid gel
15967217|NCT03133312|Drug|Chlorhexidine Gluconate|Pre-operative vaginal preparation with 4% Chlorhexidine Gluconate Intervention
15967218|NCT03133312|Drug|Povidone-Iodine Scrub and Paint|Pre-operative vaginal preparation with 10% Povidone-Iodine Scrub and Paint Intervention
15967219|NCT03133299|Drug|Glucocorticoids|Oral prednisolone for four months
15967220|NCT03133299|Drug|Vitamin D|Oral vitamin D for two months
15967221|NCT03133273|Other|Oncogramme®|Patient is followed within the usual care for stage 4 colorectal cancer, but an Oncogramme test will be made and chemotherapy will be adapted to the results.
15967222|NCT03133260|Diagnostic Test|Troponin|Troponin will be measured before surgery and postoperative at days 1,2 and 3.
15967223|NCT03133260|Drug|Acetylsalicylic acid|100mg acetylsalicylic acid will be started in case of MINS if no contraindication, it will be continued after hospital discharge. We will evaluate cardiovascular complications till 1 year after surgery
15967224|NCT03133260|Drug|Statin|40mg atorvastatin will be started in case of MINS if no contraindication, it will be continued after hospital discharge. We will evaluate cardiovascular complications till 1 year after surgery
15967225|NCT03133247|Drug|SHR-1316|PD-L1
15967226|NCT03133234|Drug|osimertinib|Oral dose of 80mg once daily
15967227|NCT03133221|Drug|Zydelig|Zydelig given at 150mg continuously in 28-day cycles
15967228|NCT03133208|Procedure|Blood draws|Blood draws will be collected via venipuncture or IV at hours 0, 6, 12, 18, 24, 48, 72 (7 draws total). Each draw would be up to 20 mL of blood (but no less than 10 mL).
15967229|NCT03133195|Drug|Teriparatide|Teriparatide 20 μg subcutaneous once daily for 12 weeks (Patient self administration at home by pen injector)
15967230|NCT03133195|Drug|Placebo|Placebo subcutaneous once daily for 12 weeks. (Patient self administration at home by pen injector)
15967231|NCT03133195|Dietary Supplement|Calcium supplement|1000 mg/day of elemental calcium
15967232|NCT03133195|Dietary Supplement|Vitamin D|20,000 IU/week of vitamin D2
15967233|NCT03133182|Drug|Polypharmacy|Patients who are taking >=5 unique prescription drugs in the 3 months prior to surgery
15967234|NCT03133169|Diagnostic Test|blood sample|blood sample for measuring liver and kidney function, CBC, ferritin level and erythrocyte glutamine level
15967235|NCT03133169|Diagnostic Test|Tricuspid regurge velocity|Tricuspid regurge velocity will be measured by doppler echocardiography denoting the pulmonary hypertension risk in children
15967236|NCT03133156|Other|Exercise Intervention|10-Week Aerobic Exercise Training
15967237|NCT03133143|Behavioral|Cognifit|CogniFit is an Internet browser-based digital brain training program, to improve cognitive abilities based on a personalised brain training regimen. Participants are instructed to play all games assigned by cognifit from three categories (memory, spatial perception, and mental planning) during each training session. After playing the games in these three categories, they are free to choose which exercises they wish to play.
15967238|NCT03133143|Behavioral|SIMS 4 (Maxis, Inc)|The Sims 4 is a life simulation PC game. It is purely an entertainment game without known cognitive or health-related outcomes. Does not iclude high-intensity action and competition. This specific game and non-competitive games like it in general do not improve attention, working memory, or other cognitive abilities despite being engaging and fun.
15967239|NCT03133130|Drug|BMT101|BMT101 is administered to 6 subjects in each of 4 groups.
15967240|NCT03133130|Drug|Placebo|Placebo is administered to 2 subjects in each of 4 groups.
15967241|NCT03133117|Radiation|Functional Magnetic Resonance Imaging (fMRI)|Functional Magnetic Resonance Imaging (fMRI)
15967242|NCT03133104|Other|Antenatal corticosteroids|Women and neonates with PPROM who received a repeat dose of antenatal corticosteroids, compared to women with PPROM who did not received a repeat course of antenatal corticosteriods
15967243|NCT03133091|Drug|PIEB: Patient Intermittent Epidural Boluses|Each patient were randomized to PIEB (7 ml bolus every 30 minutes, with extra boluses (PCEA) of 6 ml every 20 minutes) or PCEA (5 ml in continuous perfussion + PCEA of 5 ml every 15 minutes).
15967244|NCT03133091|Drug|PCEA: Patient Controlled Epidural Analgesia|Each patient were randomized to PIEB (7 ml bolus every 30 minutes, with extra boluses (PCEA) of 6 ml every 20 minutes) or PCEA (5 ml in continuous perfussion + PCEA of 5 ml every 15 minutes).
15967245|NCT03133078|Other|Step-Down Test (2 min)|The 2-minute single limb lateral-step down test will be used to induce lower extremity muscle fatigue. Participants will be instructed to perform a single limb lateral step-down test on a 31 cm box (12-inches), touching their heel to the floor each time as many times as possible in 2 minutes. The number of lateral step-downs will be recorded.
15967246|NCT03133078|Other|Side hop test (30 s)|The 30 second side hop test will be used to induce lower extremity muscle fatigue. Participants will be instructed to jump as many times as possible over two parallel strips of tape placed 40 cm apart, but must initiate approximately 30 degrees of knee flexion each jump. The number of successful jumps performed within 30 seconds will be recorded and used for data analysis. An unsuccessful jump will be defined as touching the tape or the area inside the tape. We will record the number of successful trials.
15967247|NCT03133065|Drug|treatment of HCV with oral direct acting antiviral therapy|A total number of 89 patients transplanted for HCV genotype 4 related end stage liver disease Were included in this study 53 PATIENTS were treated after 6 months of transplantation with sofosbuvir 400mg and weight based ribavirin for 24 weeks. 7 patients were treated with sofosbuvir 400mg + simeprevir 150 mg + weight based ribavirin for 12 weeks after 6 months post transplant. In September 2015, we started to adopt early treatment strategy for all recipients after the first 3months post- transplant. 26 recipients were treated with sofosbuvir 400mg+Daclatasvir 60mg ± weight based ribavirin for 12 weeks or 24 weeks. 2 recipient are treated with sofosbuvir 400mg + ledipasvir 90mg for 24 weeks and one recipient is treated with fixed-dose combination of ombitasvir (12.5 mg), paritaprevir (75 mg) and ritonavir (50 mg) + weight based ribavirin due to having persistent renal impairment post transplantation.
15967248|NCT03133052|Behavioral|internet-based adaptive cognitive control training program|The cognitive training will be an internet-based adaptive cognitive control training program, specific training paradigms include Flanker, 1-back, 2-back. To maintain task difficulty, the tasks will be grouped based on the task difficulty. Furthermore, each task will have various difficulty levels.
15967249|NCT03133052|Behavioral|placebo program|For the control group, a fixed, primary difficulty level program for all participants is set.
15967250|NCT03133039|Procedure|surgery, bioabsorbable screw|In this study we compare bioabsorbable and titanium screw in the hallux valgus and hallux rigidus surgery
15967251|NCT03133026|Device|Single operator cholangioscopy, Endoscopic biliary RFA|Single operator cholangioscopy will be done to acess the cause of occluded SEMS, if tumour ingrowth or overgrowth seen then endoscopic biliary RFA will be done
15967252|NCT03133013|Device|SLEEPSCOPE|Brainwave measurement device which is connected to the participant by an electrode attached to the forehead and another electrode behind one ear
15967253|NCT03132987|Other|Progressive strengthening program|The progressive strengthening program will be performed for 3 weeks and emphasize development of strength and power. Feasibility will be established if we can recruit up to 8 participants and retain at least 80% over the 3 week intervention program. We will determine effect sizes for changes outcome measures.
15967254|NCT03132974|Drug|Sogyeonghwalhyeol-tang granule|Sogyeonghwalhyeol-tang herbal extract granule
15967255|NCT03132974|Other|Sogyeonghwalhyeol-tang granule with manipulation procedure|Sogyeonghwalhyeol-tang herbal extract granule with manipulation procedure
15967256|NCT03132974|Other|Placebo with manipulation procedure|Placebo granule with manipulation procedure
15967280|NCT03132714|Drug|Clarithromycin 500mg|Administration of Clarithromycin 500mg bid for 7 days
15967281|NCT03132714|Procedure|Single application of PDT|Single application of photodynamic therapy (PDT) at day 0.
15967282|NCT03132714|Procedure|Repeated application of PDT|Repeated application of photodynamic therapy (PDT) at 0, 1, 2, 7 and 14 days post-operatively.
15967283|NCT03132701|Drug|Magnesium|Mg is administered during anesthesia until 5 minutes before surgery ends
15967257|NCT03132961|Other|Infrasound exposure|All cohorts will receive an identical infrasound exposure of equal time duration, varying only the order in which the testing is performed. To simulate the frequencies generated by a common source of environmental infrasound (wind turbines), recordings measured at a full-scale research wind turbine at the University of Minnesota will be utilized to create an infrasound stimulus. The resultant sound file consists of the fundamental frequency at approximately 0.7 Hz, equal to the blade passage rate, plus the harmonic overtones of the fundamental frequency. The presentation level is 85 dB SPL. The stimulus will be presented in a sound field.
15967258|NCT03132948|Behavioral|Physical Activity|Nintendo WII fit console, Xbox console, sport activities (soccer, basketball, yoga, walking and other physical games)
15967259|NCT03132935|Procedure|Telemedical support|Telemedical support by a physician in a telemedicine centre
15967260|NCT03132922|Genetic|Autologous genetically modified MAGE-A4ᶜ¹º³²T cells|Infusion of autologous genetically modified MAGE-A4ᶜ¹º³²T on Day 1
15967261|NCT03132922|Radiation|Autologous genetically modified MAGE-A4c1032T cells combined with low dose radiation|Up to 10 subjects will be considered for Radiation sub-study. Radiation with an intensity of 1.4Gy for 5 days before infusion of MAGE-A4c1032T cells
15967262|NCT03132909|Other|Feelings Determination|Determine the feelings of doctors caring for their colleagues
15967263|NCT03132870|Other|Define predictive criteria for the diagnostic performance of echo-guide samples by mini-probe in peripheral lung lesions|Define predictive criteria for the diagnostic performance of echo-guide samples by mini-probe in peripheral lung lesions
15967264|NCT03132857|Other|Assess the state of knowledge of the subjects falling or at risk, their risk of recurrence or first episode, compared to medical knowledge.|Assess the state of knowledge of the subjects falling or at risk, their risk of recurrence or first episode, compared to medical knowledge.
15967265|NCT03132844|Other|Analysis records of patients over 75 years of age|Demonstrate the percentage of patients over 75 years of age attending general medicine in the Somme, with an up-to-date vaccination schedule, in view of the HAS 2016 recommendations, for the following vaccines: DTp, influenza, pneumococcus, shingles.
15967266|NCT03132831|Other|Determine the DMS of the Total Hip Prosthesis of the University Hospital of Amiens (PTH) and the Total Knee Prosthesis (PTG)|To determine the DMS of the orthopedic department of the Amiens University Hospital after Total Hip Prosthesis (PTH) and First-line Total Knee Prosthesis (PTG) with its confidence interval and to compare it according to the patient's day of operation
15967267|NCT03132818|Other|To evaluate the prevalence of sexual disorders in patients receiving AMP|To evaluate the prevalence of sexual disorders in patients receiving AMP
15967268|NCT03132805|Behavioral|PATHS to PAX|A universal classroom-based preventive intervention designed to prevent aggression.
15967269|NCT03132805|Behavioral|PATHS to PAX and the Incredible Years|A universal classroom-based preventive intervention in combination with an indicated preventive intervention, both of which are designed to prevent aggression.
15967270|NCT03132792|Genetic|Autologous genetically modified AFPᶜ³³²T cells|Infusion of autologous genetically modified AFPᶜ³³²T cells
15967271|NCT03132779|Drug|Intralipid|Adose of intralipid given and rechecking NKcells activity
15967272|NCT03132766|Behavioral|Case Management|Community Mental Health Workers (CMHW), who are trained surveillance system staff, will conduct the monitoring and case management visits in participants' homes or other private settings at baseline, 1, 2, 3 and 6 months post-enrollment. The CM visit includes rapport-building, use of the SIQ to assess imminent risk, and referral to a local mental health center. Case managers will also facilitate connections to other care providers (traditional healers, church, Indian Health Service (IHS) social services/mental health, and private providers).
15967273|NCT03132766|Behavioral|New Hope Curriculum|New Hope (NH) is psychoeducation to supplement and promote mental health services, while encouraging connections to traditional healers and caring adults. The intervention is designed to be implemented over 1 visit (2-4 hours) in a youth-preferred setting. NH emphasizes the seriousness of a suicide attempt; teaches coping skills to reduce risk, including emotion regulation, cognitive restructuring, social support, and safety planning; and helps participants overcome barriers to treatment motivation, initiation, and adherence. A center-piece of the intervention is a 20-minute video produced by WMAT-CAIH with Native actors, vignettes specific to this community, and Elders speaking in their tribal language (with sub-titles) about the seriousness of suicide, its impact on the community, their concern for the adolescent, and beliefs about the communal importance of each individual's life. Youth are encouraged to choose a support person from his/her family to take part in the intervention.
15967274|NCT03132766|Behavioral|Elders' Resilience Curriculum|Elders' Resiliency (ER) intervention. Apache traditions confer behavioral repertoires and values taught through storytelling, observation, and parenting at the family and community level that have carried the Apache people through generations of adversity and historical trauma. ER is a brief (2-4 hours) distillation of these concepts intended to bolster Apache youths' resilience to suicide ideation, attempts and substance abuse by promoting Apache cultural identity and values, youth's self-worth and role in the community, and fostering connectedness to society and community, with an emphasis on extended family as a nexus of strength.
15967275|NCT03132753|Behavioral|SUPPORT|SUPPORT clients will be offered 12 months of support service with a recovery coach. The recovery coach will guide the client through their recovery, offering guidance and support, while coordinating their treatment services, including support services. The program will provide clients with up to $700 worth of vouchers to cover the cost of additional flexible support services over the 12 months of program enrollment, which will be personalized to fit the needs of the client. These cost vouchers will cover support services, such as housing, employment services, substance use treatment, transportation, childcare, educational or vocational services, or aftercare planning. The costs of each service is determined by the service provider. Further, the recovery coach will assist the client in choosing appropriate services and coordinating/monitoring service completion.
15967276|NCT03132727|Other|Pharyngo laryngeal MRI|"Patients will be outgoing a pharyngolaryngeal MRI, with injection of gadolinium, in addition to the CT imaging. They will have this MRI in case of doubt about cartilage invasion. It will be realised during the time between the CT imaging and the day of surgery.
~Device : gadolinium-based MRI contrast agent This will be realized according to the standard procedure."
15967277|NCT03132714|Procedure|Full-mouth ultrasonic debridement|Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
15967278|NCT03132714|Drug|Amoxicillin 500mg|Administration of Amoxicillin 500mg tid for 7 days
15967284|NCT03132701|Drug|Saline|Same volume of saline is infused until 5 minutes before surgery ends
15967285|NCT03132688|Drug|Propofol|Intravenous administration with dose of 100-200mcg/kg/min
15967286|NCT03132675|Biological|tavokinogene telseplasmid|Intratumoral tavokinogene telseplasmid (tavo, pIL-12) delivered by electroporation every 6 weeks
15967287|NCT03132675|Biological|Pembrolizumab|Intravenous 3 weekly treatments
15967288|NCT03132675|Device|ImmunoPulse|Device that electroporates the tavokinogene telseplasmid
15967289|NCT03132662|Dietary Supplement|Omega-3|3 gr/day of Omega-3
15967290|NCT03132662|Dietary Supplement|Very Low Calorie Diet|4 servings/day Optifast
15967291|NCT03132636|Drug|cemiplimab|Regimen as per protocol
15967292|NCT03132623|Drug|andrographolide sulfonate|Xiyanping injection 10-20ml/d, With 0.9% Sodium Chloride Injection 100ml-250ml diluted intravenous drip (not with other drugs in the same container mixed use), control drip speed per minute of 30-40 drops.
15967293|NCT03132623|Drug|andrographolide sulfonate simulation|Xiyanping injection simulation(0.9% normal saline) 10-20ml/d, The treatment method is the same as the experimental group.
15967294|NCT03132610|Drug|andrographolide sulfonate|Conventional Therapy+Xiyanping injection
15967295|NCT03132610|Drug|andrographolide sulfonate simulation|Conventional Therapy+Xiyanping injection simulation
15967296|NCT03132597|Behavioral|Mindfulness training|six weeks of 2 hours class of mindfulness training and orientations for home training
15967297|NCT03132584|Drug|Cyclophosphamide|"The chemotherapy drugs will be given in the hospital. During the first cycle of treatment, participants will stay in the hospital until their blood counts have recovered after treatment. During cycles 2 and 3, participants may go home after chemotherapy if they are doing well. The length of each cycle is 28 days
~- Via IV Day 3"
15967298|NCT03132584|Drug|Alemtuzumab|"The chemotherapy drugs will be given in the hospital. During the first cycle of treatment, participants will stay in the hospital until their blood counts have recovered after treatment. During cycles 2 and 3, participants may go home after chemotherapy if they are doing well. The length of each cycle is 28 days
~Alemtuzumab will be administered as follows:
~IV Day 1
~IV Day 2
~Target dose IV on Day 3 and 4"
15967299|NCT03132571|Drug|Naltrexone|37.mg oral capsule taken once daily for over the course of the study (16 weeks)
15967300|NCT03132571|Drug|Bupropion|Extended release bupropion taken once daily for the course of the study (16 weeks) flexible dosing up to 450mg target.
15967301|NCT03132571|Other|Placebo|Oral placebo taken once daily for the course of the study (16 week)
15967302|NCT03132558|Drug|Radiopaque Media|
15967303|NCT03132545|Diagnostic Test|SenseWear Armband (SWA) monitoring|Participants wore the SWA on their right arm
15967304|NCT03132545|Diagnostic Test|total body dual-energy X-ray absorptiometry|DEXA was used to estimate abdominal visceral adipose tissue and subcutaneous adipose tissue
15967305|NCT03132532|Device|Proton Beam Therapy|Proton Beam Therapy (radiation) at either 60 Gy, 66 Gy, or 72 Gy.
15967306|NCT03132532|Drug|Carboplatin|IV infusion at standard dose, route, and schedule. Concurrent chemotherapy, Carboplatin, weekly during radiotherapy followed 3-6 weeks later by 2 cycles of consolidative chemotherapy
15967307|NCT03132532|Drug|Paclitaxel|IV infusion at standard dose, route, and schedule. Concurrent chemotherapy, Paclitaxel, weekly during radiotherapy followed 3-6 weeks later by 2 cycles of consolidative chemotherapy
15967308|NCT03132519|Drug|Remifentanil|To maintain remifentanil Ce at 1.0 (control) vs. 2.0 vs. 2.5 ng/ml by a TCI system during anesthesia emergence until tracheal extubation
15967309|NCT03132506|Other|patient-reported-outcomes|Explorative pilot study combining collected data from the PRAEGNANT study on paper-based patient-reported-outcomes with additional collected data on web-based patient-reported-outcomes
15967310|NCT03132493|Drug|Nivolumab 10 MG/ML|nivolumab 3 mg/kg as an intravenous infusion every 2 weeks until progression
15967311|NCT03132480|Other|fluid resuscitation|when the patients showed the clinical signs of hypovolemia, the fluid resuscitation with 10ml/kg crystalloid solution was performed.
15967312|NCT03132467|Biological|Durvalumab|Given IV
15967313|NCT03132467|Biological|Tremelimumab|Given IV
15967314|NCT03132454|Drug|Decitabine|Given IV
15967315|NCT03132454|Drug|Dexamethasone|Given IV or PO
15967316|NCT03132454|Drug|Palbociclib|Given PO
15967317|NCT03132454|Drug|Sorafenib|Given PO
15967318|NCT03132441|Other|Strength Training for Frailty|Cardiac Rehabilitation, abbreviated course
15967319|NCT03132428|Drug|INOmax|Nitric oxide gas for inhalation provided via mechanical ventilation or non invasive ventilation
15967320|NCT03132415|Behavioral|Get Connected|The investigators designed the intervention to help participants increase their HIV risk awareness, promote self-appraisal and increase motivation for engaging in prevention services, problem solving barriers to accessing care, and locating culturally-sensitive providers. Intervention content is customized based on participants' socio-demographic characteristics, HIV/STI testing history and testing motivations, and recent sexual behaviors.
15967321|NCT03132415|Behavioral|AIDSVu|The investigators will use AIDSVu's available HIV/STI testing locator as the attention-control condition. The AIDSVu test locator provides a list of HIV testing sites in a city or zipcode.
15967322|NCT03132402|Diagnostic Test|ELISA validation|ELISA validation of hypersensitive rapid diagnostic test results for detection of P. falciparum
15967323|NCT03132389|Other|No intervention|All patients included in the study will be offered the same examination and treatment procedure as the patients who are not included. Identical procedures and examinations will be performed in participants and non-participants.
15967324|NCT03132376|Dietary Supplement|Water Preload Drink|Participants were given 275 ml (0 kcal) water to consume in the morning following an overnight fast. This served as the control drink.
15967325|NCT03132376|Dietary Supplement|Whey Protein Isolate Drink|Participants were given an isovolumetric (to the water), 160 kcal drink with 30 g whey protein to consume in the morning following an overnight fast.
15967326|NCT03132376|Dietary Supplement|Micellar Casein Protein Drink|Participants were given an isovolumetric (to the water), 160 kcal drink with 30 g micellar casein to consume in the morning following an overnight fast.
15967327|NCT03132376|Dietary Supplement|Egg White Isolate Protein Drink|Participants were given an isovolumetric (to the water), 160 kcal drink with 30 g egg white isolate protein to consume in the morning following an overnight fast.
15967328|NCT03132376|Dietary Supplement|Egg White Concentrate Protein Drink|Participants were given an isovolumetric (to the water), 160 kcal drink with 30 g egg white concentrate protein to consume in the morning following an overnight fast.
15967329|NCT03132337|Other|Serial Blood Draws|Day 0 and Day 3 blood draw for SOS biomarkers. If subject develops SOS blood draw prior to dose of Defibrotide, Day 14 after Defibrotide and Day 21 after Defibrotide.
15967330|NCT03132324|Drug|INCB059872|INCB059872 tablets
15967331|NCT03132311|Biological|Yellow Fever vaccination (17 DD Biomanguinhos)|One intramuscular injection
15967332|NCT03132298|Other|Implicit Theories of Personality Program|This 30-minute, self-administered computer program teaches youths that personality is malleable, as opposed to fixed, due to the human brain's constant potential for change and growth (i.e., neuroplasticity).
15967333|NCT03132298|Other|Control Program|This 30-minute, self-administered computer program was designed to control for nonspecific aspects of completing a series of computer-based activities in the context of the present study. It was also designed to mimic 'supportive therapy' that youths might receive in usual care settings, stressing the importance of sharing one's feelings with close others.
15967334|NCT03132285|Device|PrePex|Prepex is a non surgical male circumcision device
15967335|NCT03132272|Device|Immunoadsorption with Globaffin|Immunoadsorption for treatment of persons with Alzheimer Dementia
15967336|NCT03132259|Drug|high dose dexmedethomidine|Dexmedethomidine continuous drip 0.5 mcg/kg/hr a
15967337|NCT03132259|Drug|low dose dexmedethomidine|Dexmedethomidine continuous drip 0.2 mcg/kg/hr
15967338|NCT03132246|Diagnostic Test|Blood draws|The only intervention patients experience are non-standard of care blood draws. The blood is then tested in a basic science laboratory.
15967339|NCT03132233|Dietary Supplement|Beta-hydroxybutyrate calcium and magnesium salt|Exogenous ketone body in mineral salt form.
15967340|NCT03132233|Other|placebo powder|matched placebo powder to the IMP.
15967341|NCT03132220|Behavioral|Mindfulness-Based Cognitive Therapy|Mindfulness-Based Cognitive therapy is a 16 in-person hours intervention. The intervention in this population is designed to reduce symptoms of PTSD and BOS and increase resiliency scores.
15967342|NCT03132220|Behavioral|Book Club Active Control Intervention|Participants randomized to the book club active control intervention will meet for 16 in-person hours that are broken into sessions. Books will be assigned to read during homework time and discussions regarding the books will occur during the sessions. The time involved will be similar to the MBCT intervention.
15967343|NCT03132207|Other|Non interventionel study|Only one questionnaire will be done for women and professional
15967344|NCT03132194|Drug|DPSG 7.5%|topical gel
15967345|NCT03132194|Drug|Aczone|topical gel
15967346|NCT03132194|Drug|Placebo|topical gel
15967347|NCT03132181|Drug|Empagliflozin|Patient will be treaded according to standard care but additionally take one tablet Empagliflozin per day
15967348|NCT03132181|Other|Placebo|Patient will be treaded according to standard care but additionally take one tablet placebo per day
15967349|NCT03132168|Behavioral|Assessments|These cognitive assessments will be utilized during the study to evaluate cognitive levels comparing prior to surgery and post-operatively in order to determine if the subject is delirious. BIS monitoring will be utilized for all subjects.
15967350|NCT03132168|Procedure|Blood Draw|Subjects will have blood draws at surgical preadmission visit, Day 1, Day 2, and Day 3 post surgery only; one tube containing approximately one teaspoon (5 mL) of blood will be drawn at each visit.
15967351|NCT03132168|Other|Standardized Anesthetic Care|Standardized anesthetic care will be provided as described by the protocol for each subject consented for this trial.
15967352|NCT03132155|Drug|AMG 337|6-{(1R)-1-[8-fluoro-6-(1-methyl-1H-pyrazol-4-yl)[1,2,4]triazolo[4,3-a]pyridin-3-yl]ethyl}-3-(2-methoxyethoxy)-1,6-naphthyridin-5(6H)-one•hydrate (1:1)
15967353|NCT03132142|Drug|Capsaicin|4x4 cm patch of 8% topical capsaicin applied to the skin of the volar forearm for 1 hour 4 times on 4 consecutive days
15967354|NCT03132142|Drug|Trans-cinnamaldehyde|1mL of 10% trans-cinnamaldehyde applied to the skin of the volar forearm for 1 hour 4 times on 4 consecutive days
15967355|NCT03132142|Drug|L-Menthol|1mL of 40% L-menthol applied to the skin of the volar forearm for 1 hour 4 times on 4 consecutive days
15967356|NCT03132142|Drug|Vehicle patch|Inert vehicle patch applied to the skin of the volar forearm for 1 hour 4 times on 4 consecutive days
15967357|NCT03132129|Diagnostic Test|Cardiovascular magnetic resonance (CMR) imaging and magnetic resonance spectroscopy|CMR scanning performed on a 3T MRI scanner. Standardised protocol incorporating cine functional assessment to determine LV mass, systolic function and left atrial volumes; global systolic strain and diastolic strain rates will be assessed by tagging and with tissue tracking analysis from cine images, adenosine rest and stress myocardial perfusion to assess reserve index and qualitative perfusion defects as previously described, aortic distensibility and pulse wave velocity to measure aortic stiffness, delayed contrast enhancement for assessment of LV fibrosis and evidence of previous myocardial infarction. Myocardial and liver triglyceride content will be assessed using the modified Hepafat® sequence or 1H MR spectroscopy at the inter ventricular septum.
15967358|NCT03132129|Diagnostic Test|Transthoracic echocardiography|Comprehensive transthoracic echocardiography, including: tissue Doppler indices of diastolic filling and speckle tracking for systolic and diastolic strain/strain rate, exclusion of valvular abnormalities, assessment of LV size and function.
15967359|NCT03132129|Diagnostic Test|Computed tomography coronary artery calcium scoring|Computed Tomography coronary calcium scoring to assess the presence of subclinical atherosclerosis and allow an estimate of atheroma burden.
15967360|NCT03132129|Diagnostic Test|Cardiopulmonary exercise testing|Physician supervised incremental symptom limited cardiopulmonary exercise tolerance test with ECG and haemodynamic monitoring.
15967361|NCT03132116|Drug|gentamicin|"After inclusion in the study, patient will be randomized. According to randomization, patient will receive an intra-nodal injection of gentamicin .
~As well, azithromycin will be prescribed for all patients for 5 days. Patients will be followed-up each week until week 4 (Day 28)."
15967362|NCT03132116|Drug|placebo|"After inclusion in the study, patient will be randomized. According to randomization, patient will receive an intra-nodal injection of placebo.
~As well, azithromycin will be prescribed for all patients for 5 days. Patients will be followed-up each week until week 4 (Day 28)."
15967363|NCT03132103|Dietary Supplement|Oral Vitamin D3|
15967367|NCT03132090|Diagnostic Test|PET/MR (Biograph mMR)|The combination of PET and MRI allows for evaluation of metabolic, functional and morphological parameters such as glucose metabolism, perfusion, diffusion restriction or size in one examination. Due to the combination of MRI and PET in one scanner it is possible to align the acquired PET and MR datasets with high precision
15967368|NCT03132077|Procedure|total knee arthroplasty|surgical intervention for end stage of knee osteoarthritis
15967369|NCT03132064|Procedure|total knee arthroplasty|surgical repair for end stage of knee osteoarthritis.
15967370|NCT03132051|Drug|steroid injection|ultrasound-guided steroid injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide
15967371|NCT03132038|Drug|Nivolumab|3 mg/kg, every two weeks, during a maximum of one year
15967372|NCT03132025|Drug|"Apatinib and Capecitabine"|"Combine Apatinib and Capecitabine to Maintain Treating Metastatic Colorectal Cancer"
15967373|NCT03132025|Drug|"Capecitabine"|"Single Drug Capecitabine to Maintain Treating Metastatic Colorectal Cancer"
15967374|NCT03132012|Behavioral|Indoor tanning intervention|6 Web-based modules that focus on preventing skin cancer through sun protection and indoor tanning reduction using the Theory of Planned Behavior and Prospect Theory
15967375|NCT03132012|Behavioral|Standard of care control|One website with content similar to those available in dermatology offices on skin cancer prevention
15967376|NCT03131999|Drug|Imatinib Mesylate 400Mg Capsule|Sirolimus or everolimus will be withdrawn after 28 days if used at baseline
15967377|NCT03131999|Drug|Placebo - Capsule|Sirolimus or everolimus will be withdrawn after 28 days if used at baseline
15967378|NCT03131973|Drug|BMS-986195|Specified dose on specified days
15967379|NCT03131973|Drug|Methotrexate|Specified dose on specified days
15967380|NCT03131973|Drug|Leucovorin|Specified dose on specified days
15967381|NCT03131973|Drug|Caffeine|Specified dose on specified days
15967382|NCT03131973|Drug|Montelukast|Specified dose on specified days
15967383|NCT03131973|Drug|Flurbiprofen|Specified dose on specified days
15967384|NCT03131973|Drug|Omeprazole|Specified dose on specified days
15967385|NCT03131973|Drug|Midazolam|Specified dose on specified days
15967386|NCT03131973|Drug|Digoxin|Specified dose on specified days
15967387|NCT03131973|Drug|Pravastatin|Specified dose on specified days
15967388|NCT03131960|Device|Paired Vagus Nerve Stimulation|Stimulation of the vagus nerve that is paired with upper limb rehabilitation movements.
15967389|NCT03131960|Other|Rehabilitation|Rehabilitation movements to improve upper limb function after stroke
15967390|NCT03131947|Other|HIV positive patients|As above
15967391|NCT03131934|Biological|Autologous EBV-CTL transduced with vector SFG-CNA12|Autologous EBV-specific cytotoxic T-cells (CTL) transduced with the retroviral vector SFG-CNA12 conferring resistance to tacrolimus
15967392|NCT03131934|Biological|Autologous EBV-CTL transduced with control vector SFG-CNA8|Autologous EBV-specific cytotoxic T-cells (CTL) transduced with the control retroviral vector SFG-CNA8
15967393|NCT03131934|Procedure|Leucapheresis|Patients will undergo an unstimulated leucapheresis to isolate the required immune cells to produce the EBV-CTLs
15967394|NCT03131908|Drug|GSK2636771|"Phase I Starting Dose of GSK2636771: 300 mg by mouth given for 21 days.
~Phase II Dose of GSK2636771: Maximum tolerated dose from Phase I."
15967395|NCT03131908|Drug|Pembrolizumab|Phase I and II Dose of Pembrolizumab: 200 mg given by vein every 3 weeks.
15967396|NCT03131895|Drug|30 mg dexlansoprazole capsules manufactured at TOB|Dexlansoprazole delayed-release.
15967397|NCT03131895|Drug|30 mg dexlansoprazole capsules manufactured at TPC|Dexlansoprazole delayed-release.
15967398|NCT03131895|Drug|60 mg dexlansoprazole capsules manufactured at TOB|Dexlansoprazole delayed-release.
15967399|NCT03131895|Drug|60 mg dexlansoprazole capsules manufactured at TPC|Dexlansoprazole delayed-release.
15967400|NCT03131882|Drug|Hyaluronic Acid|1 ml of Low molecular weight hyaluronic acid injection under ultrasound guidance after subcutaneous 0.5ml of 1%lidocaine injection
15967401|NCT03131882|Drug|Triamcinolone Acetonide|1ml of 10 mg of triamcinolone injection under ultrasound guidance after subcutaneous 0.5 ml 1%lidocaine injection
15967402|NCT03131869|Other|Thickened Beverages Nectar|Thickened beverages in nectar consistency
15967403|NCT03131869|Other|Thickened Beverage Honey|Thickened beverages in honey consistency
15967404|NCT03131856|Behavioral|Nutritional intervention programme|The intervention consisted of an individual dietary plan conducted by a clinical dietician before discharge in combination with three follow-up visits after discharge (1, 4 and 8 weeks) conducted by a district nurse.
15967405|NCT03131843|Drug|Alcohol|Alcohol cleansing swab/wipe
15967406|NCT03131843|Drug|No alcohol|No alcohol will be used; alcohol cleansing swab/wipe will be used at a different injection site
15967407|NCT03131830|Other|Online-based questionnaire|Participants receive a web-link to a questionnaire, which is active for 3 months
15967408|NCT03131817|Device|Activa PC+S Prefrontal|
15967409|NCT03131804|Other|Intradialytic aerobic low intensity exercise|Intradialytic aerobic low intensity exercise program of 45 minutes per each hemodialysis session throughout the 6-month study duration
15967410|NCT03131791|Device|Shock Wave|42 chronic stroke patients with upper limb spasticity were randomly assigned to receive either 1 session of ESWT per week for 3 consecutive weeks or BoNT-A injection. The biceps, flexor carpi radialis, and flexor carpi ulnaris muscles were treated. Assessments were performed at baseline and at 1, 4, and 8 weeks after the intervention. The primary outcome measure was the change in the Modified Ashworth Scale (MAS) score for the elbow from the baseline to after 4 weeks of treatment.
15967411|NCT03131791|Drug|Botulinum toxin A|42 chronic stroke patients with upper limb spasticity were randomly assigned to receive either 1 session of ESWT per week for 3 consecutive weeks or BoNT-A injection. The biceps, flexor carpi radialis, and flexor carpi ulnaris muscles were treated. Assessments were performed at baseline and at 1, 4, and 8 weeks after the intervention. The primary outcome measure was the change in the Modified Ashworth Scale (MAS) score for the elbow from the baseline to after 4 weeks of treatment.
15967412|NCT03131778|Procedure|Liver resection|liver resections for colorectal liver metastases
15967413|NCT03131765|Biological|YS-0N-001|Cancer vaccine
15967540|NCT03130686|Device|OMRON blood pressure monitor HEM-9210T|To measure systolic blood pressure, diastolic blood pressure and pulse rate in patients.
15967414|NCT03131752|Behavioral|Elastic Resistance Intervention in Exacerbated Patients|The intervention protocol will performed during 7 days for all patients and this will begin 24 -48 hours after the start of medication for exacerbation. Those who are hospitalized and discharged before this period will continue their treatment at the Laboratory of Spirometry and Respiratory Physiotherapy (LEFIR) of the Federal University of São Carlos. The intervention will also perform for at least 5 continuous days. The ideal elastic band for the training will be chosen through the test of 10 maximum repetitions. The test and the training will be performed in an ergonomic chair allowing the lower limbs to remain pending. After 24 hours of the test, patients will perform knee extension exercise with the appropriate elastic band. Three sets of 10 repetitions will be done in each exercise, with a minimum rest interval of 1 minute between sets or until heart rate values return to baseline. Patients will be re-evaluated 1 and 3 months after the first contact.
15967415|NCT03131726|Drug|Simvastatin 40mg|see arm description
15967416|NCT03131713|Drug|Acetaminophen|Acetaminophen 1000mg
15967417|NCT03131700|Biological|RPH001|Avastin® has been approved for treatment of various cancers in many countries of the world including the USA, EU countries, and Turkey. In Turkey, Avastin® is approved with a different trade name, Altuzan®, for treatment of metastatic colorectal cancer.
15967418|NCT03131700|Biological|Avastin®|R-Pharm created a biological analog of Avastin®, RPH-001. RPH-001 and Avastin® have similar physicochemical properties, pharmacokinetic profile and affinity to human vascular endothelial growth factor, similar toxicity and efficacy confirmed by preclinical study results.
15967419|NCT03131687|Drug|tirzepatide|Administered SC
15967420|NCT03131687|Drug|Dulaglutide|Administered SC
15967421|NCT03131687|Drug|Placebo|Administered SC
15967422|NCT03131674|Other|Cervical physical therapy|Patients receive a multimodal cervical physical therapy treatment
15967423|NCT03131648|Drug|Tralokinumab|Tralokinumab is a human recombinant monoclonal antibody of the IgG4 subclass that specifically binds to human IL-13 and blocks interaction with the IL-13 receptors. It is presented as a liquid formulation for subcutaneous (SC) administration
15967424|NCT03131648|Drug|Placebo|Placebo contains the same excipients, in the same concentration only lacking tralokinumab
15967425|NCT03131635|Behavioral|Developmental Reciprocity Treatment Program (DRT-P)|Developmental Reciprocity Treatment is an early intervention that applies developmentally-informed teaching methods in naturalistic settings in order to target social and communication deficits.
15967426|NCT03131622|Behavioral|Digital Therapeutics|
15967427|NCT03131609|Other|Container|Ambulatory patients in the Emergency Department who have a urine culture ordered by the physician receive one of four urine collection/hygiene options.
15967428|NCT03131609|Other|Silver Impregnated Wipe|Ambulatory patients in the Emergency Department who have a urine culture ordered by the physician receive one of four urine collection/hygiene options.
15967429|NCT03131609|Other|Funnel|Ambulatory patients in the Emergency Department who have a urine culture ordered by the physician receive one of four urine collection/hygiene options.
15967430|NCT03131609|Other|Castile-soap wipe|Ambulatory patients in the Emergency Department who have a urine culture ordered by the physician receive one of four urine collection/hygiene options.
15967431|NCT03131596|Procedure|IUB dilatation therapy|A Foley catheter (size 14fr) will be prepared by cutting the excess catheter tip protruding beyond the balloon prior to insertion into the uterine cavity. Once the catheter has reached the fundus, 3-4.5mls of saline will be slowly introduced into the balloon under ultrasound guidance, in order to directly visualize the distention of the cavity and division of any intrauterine adhesions, if present.
15967432|NCT03131583|Drug|Colchicine|Day-14~Day16 qd
15967433|NCT03131583|Drug|Febuxostat|Day1 and Day8 qd
15967434|NCT03131583|Drug|SHR4640|Day3~Day8 qd
15967435|NCT03131570|Drug|Secukinumab|Arms: Group 1 - Group 1 will receive Secukinumab at a dose of 300 mg with injections administered once weekly at baseline and at weeks 1, 2, 3, and 4 and then every 4 weeks for 6 months of period. In order to maintain the blind for the Group 2, Group 1 will receive placebo injections at weeks 13, 14, and 15. Group 1 will discontinue Secukinumab after 6 months of period being observed from week 25 to week 72 (48 weeks).
15967436|NCT03131570|Drug|Placebo followed by Secukinumab|Arms: Group 2 - Group 2 will receive placebo injections corresponding to the Group 1 regimen until week 8 in order to maintain a double-dummy design until week 12. From week 12, Group 2 will receive Secukinumab with injections administered once weekly at week 12 and at weeks 13, 14, 15, and 16 and then every 4 weeks for 3 months of period. Group 2 will discontinue Secukinumab after 6 months of period being observed from week 25 to week 72 (48 weeks).
15967437|NCT03131557|Device|Line extension of the Phonak Audéo B product family|The line extension of the Phonak Audéo B product family will be fitted to the participants individual hearing loss.
15967438|NCT03131557|Device|Phonak Audéo B|Phonak Audéo B will be fitted to the participants individual hearing loss.
15967439|NCT03131544|Device|MRI Guided Transrectal Periuretheral Transitional Zone Ablation|Patients will undergo an MRI guided transrectal ablation of tissue within the periuretheral transitional zone.
15967440|NCT03131531|Other|Patient registry|Clinical data, specific procedures and treatments will follow the Institutional standard operative procedures
15967441|NCT03131518|Behavioral|Access to an e-bicycle with trailer|Participants will be provided with an e-bike with trailer for 3 months.
15967442|NCT03131518|Behavioral|Access to a longtail bicycle|Participants will be provided with a longtail bike for 3 months.
15967443|NCT03131518|Behavioral|Access to a traditional bike with trailer|Participants will be provided with a traditional bicycle with trailer for 3 months.
15967444|NCT03131492|Diagnostic Test|Blood test|C-reactive protein and PCT measured preoperatively, and on the second, fourth and sixth postoperative days.
15967445|NCT03131479|Drug|LIK066|LIK066 50 mg tablets taken orally once daily before breakfast for 7 days.
15967448|NCT03131453|Drug|CNP520 50mg|50 mg capsule
15967449|NCT03131453|Drug|CNP520 15mg|15 mg capsule
15967450|NCT03131453|Other|Matching placebo|Matching placebo for 15 and 50 mg capsules
15967451|NCT03131440|Behavioral|Core|The core intervention will include educational materials, access to a basic smartphone app and a Fitbit.
15967452|NCT03131440|Behavioral|Support Calls|Participants will receive 6 bi-weekly phone calls from study staff.
15967453|NCT03131440|Behavioral|App+|"Participants will receive deluxe version of smartphone app with additional features."
15967454|NCT03131440|Behavioral|Online gym|Participants will receive access to online exercise videos.
15967455|NCT03131440|Behavioral|App notifications|Participants will receive motivational app notifications
15967456|NCT03131440|Behavioral|Buddy|Participants will choose a buddy to receive a Fitbit and support them during the intervention.
15967457|NCT03131427|Drug|Standard of care|Standard of care according to the updated national and/or international guidelines
15967458|NCT03131414|Other|Diet|Dietary intake
15967459|NCT03131414|Other|Gastrointestinal microbiome|Genomic sequencing of stool for gut bacteria
15967460|NCT03131401|Diagnostic Test|Diagnosis of lymphatic filariasis|Field validation of the diagnostic performance of diagnostic tests for infection with W. bancrofti.
15967461|NCT03131401|Diagnostic Test|Diagnosis of lymphatic Filariasis and onchocerciasis|Field validation of the diagnostic performance of diagnostic tests for infection with both W. bancrofti and O. volvulus.
15967462|NCT03131401|Diagnostic Test|DEC Patch|Field validation of the diagnostic performance of diagnostic tests for infection with O. volvulus.
15967463|NCT03131388|Diagnostic Test|Access AMH Assay|
15967464|NCT03131375|Drug|Dexmedetomidine|Group A and B: Anesthesia induction drugs:propofol, fentanyl, rocuronium . After induction of anesthesia: Group A receives a 50 ml NS infusion containing 1 mcg kg-1 Dexmedetomidine drug Group A and B: Atropine as an antisialagogue, dexamethasone, ondasetrone for the prevention of postoperative nausea and vomiting. Anesthesia maintainance: propofol, remifentanil and oxygen in air. End of surgery, the infusion of propofol and remifentanil stop and sugammadex for reversal of neuromuscular block is given. Postoperative analgesia by nalbuphine 0.2 mg kg-1 given before the end of surgery in Group B, and 0.16 mg kg-1 in Group A. Monitoring: ECG, NIBP, ETCO2, SpO2, Bispectral index , Train of four ratio.
15967465|NCT03131375|Drug|Normal saline|Group A and B: Anesthesia induction drugs:propofol, fentanyl, rocuronium . After induction of anesthesia: Group B receives a volume matched Normal saline infusion. Group A and B: Atropine as an antisialagogue, dexamethasone, ondasetrone for the prevention of postoperative nausea and vomiting. Anesthesia maintainance: propofol, remifentanil and oxygen in air. End of surgery, the infusion of propofol and remifentanil stop and sugammadex for reversal of neuromuscular block is given. Postoperative analgesia by nalbuphine 0.2 mg kg-1 given before the end of surgery in Group B. Monitoring: ECG, NIBP, ETCO2, SpO2, Bispectral index, Train of four ratio.
15967466|NCT03131375|Device|Bispectral index|Group A and B: Monitoring depth of anesthesia by BIS device and adjusting propofol infusion according to measurements, aiming to BIS values: 40-60
15967467|NCT03131375|Device|Train of four ratio|Group A and B: Monitoring recovery of neuromuscular function with TOF-Watch device, to ensure TOFR equals or greater than 90% at the end of the procedure
15967468|NCT03131349|Diagnostic Test|serum zinc and iron|history ,examination,investigations
15967469|NCT03131336|Drug|PeproStat|solution for local application
15967470|NCT03131336|Drug|Saline|solution for local application
15967471|NCT03131323|Procedure|• Flexible fiberopticnasopharyngoscope|".
~II- Equipments:
~Flexible fiberopticnasopharyngoscope, 2.7 mm in diameter and fiberoptic light cable.
~The camera: fitted with Three-CCD (Charged Couple Device) sensors.
~A high resolution monitor.
~A recording unit. III- Positioning:Infants and small children have to be held by a parent or an adult. Older children and adolescents usually tolerate office flexible nasopharyngoscopy once the procedure is explained. If office flexible nasopharyngoscopy failed because the child is not cooperative or if there is excessive secretions, general anesthesia may be required [8].
~IV- Technique: Lubricant gel will be applied to the tip of the endoscope which will be now will be passed along the floor of the nose, between the inferior turbinate and the nasal septum, till it reaches the nasopharynx. Now the entire nose and the nasopharynx could be thoroughly examined and any abnormal findings could be detected and documented."
15967472|NCT03131310|Other|clinical audit|is to assess the quality of care and management of children with cardiorespiratory arrest admitted to assuit university children hospital according to the American Heart Association (AHA) Guidelines for Cardiopulmonary Resuscitation
15967473|NCT03131297|Procedure|treatment by radiofrequency|Radiofrequency might destroy fistula tract without lesion of anal sphincter.
15967474|NCT03131284|Behavioral|Intensive education|"For each well visit within the first two years of their child's life, parents are provided with oral and written information on behaviors to adopt for their child to be protected from obesity: breast feeding, feeding on demand, responsive feeding, correct time of introduction of complementary feeding, portions shaped on the child's appetite, avoiding pressing the child to eat more and rewarding or punishing the child with food, avoiding added sugar and beverages other than milk and water, practicing active game with the child, alternating protein sources correctly and avoiding protein excess. Written menus examples and coloured photos of average portions are given for complementary feeding. Parents are also provided with information about health consequences of childhood obesity."
15967475|NCT03131271|Other|cold application|In the experimental group, the researcher provided a cold application for 20 minutes by placing an ice bag to the site of the femoral catheter.
15967476|NCT03131258|Procedure|Donor Nephrectomy|48 Donor Nephrectomy Patients
15967477|NCT03131219|Biological|Ravulizumab|Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight.
15967541|NCT03130660|Device|Ultrasonography|Ultrasound guidance for central line
15967542|NCT03130647|Device|Focused ultrasound|Focused ultrasound
15967854|NCT03128034|Radiation|Pretargeted Radioimmunotherapy|Given 211^At-BC8-B10 IV
15967478|NCT03131206|Drug|Alectinib|"Oral, BID
~Phase I: A 7-day lead-in dosing period will be administered at the start of each dose level. Each treatment cycle will be defined as 28 consecutive days.
~Phase II: Participants will be treated at the RP2D identified during Phase I. Each treatment cycle will be defined as 28 consecutive days."
15967479|NCT03131193|Other|Physician|Study primary health centers will be staffed with an additional physician
15967480|NCT03131193|Other|Mid-level provider|Study primary health centers will be staffed with an additional mid-level provider
15967481|NCT03131193|Behavioral|Conditional Cash Transfer|Study participants (who are pregnant women) will receive a cash transfer conditional upon: registering for and attending antenatal care in the study clinic, giving birth in the study clinic and completing a postnatal visit with the new infant
15967482|NCT03131180|Other|Rapid Learning Healthcare System|The investigators created a Rapid Learning Healthcare System that integrates pre-specified data elements and validated surveys within the clinical workflow in order to operationalize automated research data collection and integrate predictive analytics into the electronic health record (EHR). Patients, caregivers, and physicians access data in order to make informed, shared decisions about care and align expectations about outcomes.
15967483|NCT03131167|Drug|SHP639 (n=60)|Drug SHP639 is a 9-amino acid, synthetic, C-type natriuretic peptide (CNP) analog.
15967484|NCT03131167|Drug|Placebo Comparator (n=24)|Drug: Vehicle Ophthalmic placebo solution of the same composition as the test product.
15967485|NCT03131154|Drug|ADX-102 Ophthalmic Solution (0.5%)|ADX-102 Ophthalmic Solution (0.5%) administered for approximately four weeks.
15967486|NCT03131154|Drug|Vehicle of ADX-102 Ophthalmic Solution|Vehicle of ADX-102 Ophthalmic Solution administered for approximately four weeks.
15967487|NCT03131141|Drug|BC-3781|Lefamulin (BC-3781) is a potent, semi-synthetic antibacterial belonging to a novel class for systemic human use known as the pleuromutilins
15967488|NCT03131128|Behavioral|Mindfulness-based Intervention|"Keeping mindful when selecting food.
~Be aware of hunger and satiety by the body clues.
~Understanding how stress affect diet and life, and learn how to cope with stress in life.
~Learning to identify overeating caused by mood, social stress and specific food."
15967489|NCT03131128|Behavioral|Health Education Intervention|"Identifying improper diet patterns and attitudes
~Understanding the impact of irrational cognition and attitudes on dietary behavior
~Training coping skills for stresses in real life and preventing the recurrence of bulimia."
15967490|NCT03131115|Procedure|Lateral Crural Strut Graft|surgical technique as described
15967491|NCT03131115|Procedure|Bone Anchored Suspension|Surgical technique as described
15967492|NCT03131076|Diagnostic Test|IPMN follow up|Follow up with MRI and laboratory blood tests
15967493|NCT03131063|Other|Antibiotic plasma dosage|Measurement of the concentration of antibiotics administered as part of the routine care of intensive care patients
15967494|NCT03131050|Drug|Scopolamine|Intramuscular injection with scopolamine (0.3 mg/1ml,QD or Bid) during the first three days;
15967495|NCT03131050|Drug|Escitalopram|Oral escitalopram 10 mg/d throughout the total of 4 weeks treatment
15967496|NCT03131050|Drug|Saline|Intramuscular injection with saline (1ml, QD or Bid) during the first three days;
15967497|NCT03131037|Biological|AdV-tk (aglatimagene besadenovec) + valacyclovir|AdV-tk will be administered intratumorally followed by oral valacyclovir. Valacyclovir will be administered orally at a fixed dose for 14 days after each AdV-tk administration.
15967498|NCT03131024|Dietary Supplement|50% caloric restriction|Meals mimicking participant dietary preferences and matching North American macronutrient guidelines will be provided consisting of 50% of total caloric intake for 48 hours
15967499|NCT03131024|Other|Aerobic exercise|The supervised exercise session will consist of a 10-minute warm-up, 30 minutes performed at 70-75% of heart rate reserve, which corresponds to a vigorous intensity, followed by a 5-minute cool-down
15967500|NCT03131011|Other|UV fluorescent ink|"The use of UV tattoo ink results in a tattoo that is visible only under an ultraviolet light. Conventional black tattoo ink is replaced with UV ink for the application of radiotherapy dot tattoos. Handheld UV flashlights are used to make the tattoos visible for use during radiotherapy treatment set-up."
15967501|NCT03130998|Behavioral|Remote Knowledge Broker (rKB)|The intervention is the tailored support received by a knowledge broker via technology in Group B. The rKB will: ensure relevant research evidence related to depression and smoking is transferred to the FHTs in ways that are most useful to them; develop capacity for evidence-informed decision-making at each site; and assist sites in translating evidence into local practice. These tasks will be accomplished by an initial 2-hour, virtual visit with each site and regular phone- and email-based check-ins. The specific tasks will be dictated by the needs of each site, and will create opportunity for practitioners to share their experiences with the rKB, learn new evidence, and work with the rKB on how to best implement the evidence.
15967502|NCT03130998|Behavioral|Emails|When a patient is screened as showing depressive symptoms, the practitioner will be prompted to intervene and refer that patient to treatment. The practitioner will receive knowledge broker support to carry out these actions in the form of one email per month for one year. The first email will provide an electronic copy of a Cochrane review (describing the link between smoking and mood) and a short description of the integration of a depression ICP in the STOP portal. The STOP YouTube channel with detailed instructions on how to use the revised portal will be made available. Subsequent communications will be based on general needs identified at baseline and content discussed in the STOP Community of Practice (teleconferences, online forum between STOP practitioners).
15967503|NCT03130959|Biological|Nivolumab|Specified dose on specified day
15967504|NCT03130959|Biological|Ipilimumab|Specified dose on specified day
15967505|NCT03130946|Device|Cryo-assisted core needle biopsy|Rotational core needle biopsy would be done under local anesthesia. A small incision would be made in the axilla and core needle biopsy be performed using a special cryo-assisted stick freeze device (Cassi II, Scion Medical Technologies, USA). The cytological and histological specimens would be sent for diagnosis.
15967506|NCT03130946|Device|FNA|FNA would be performed using a 10ml syringe with a 24 gauge needle without anesthesia.
15967543|NCT03130634|Drug|Silymarin|During six cycles of FOLFIRI chemotherapy, the patients will take silymarin (150mg) three times daily from day 1 to day 7 during one cycle of treatment.
15967544|NCT03130621|Diagnostic Test|Gene detection|Next-generation sequencing
15967855|NCT03128034|Drug|Sirolimus|Given PO
15967507|NCT03130933|Procedure|Lower third molar surgery|"All surgical procedures were performed under local anaesthesia (alveolar nerve block) with 2% lidocaine chloride. The full-thickness mucoperiosteal flap was raised using buccal approach, adequate osteotomy was done using micromotor handpiece and bur, and third molar removal was finished using elevating instruments in the appropriate direction. Removal of bone dust, granulation tissue and broken tooth fragments were done in order to wound toileting. Gentle, sterile saline irrigation was done on the end.
~Primary closure of the surgical area was done using 3-0 silk sutures."
15967508|NCT03130933|Drug|Amoxicillin 500 Mg|The tested subgroups received a prophylactic single dose of 4 x 500 Mg Amoxicillin one hour prior the lower third molar surgery.
15967509|NCT03130933|Other|Placebo|The control subgroups received a prophylactic single dose of placebo one hour prior the lower third molar surgery.
15967510|NCT03130920|Procedure|Preconditioning|"Local ischemic preconditioning (LIPC) is process during which a short period of ischemia is followed by a period of reperfusion prior to the prolonged ischemia which seems to render organs more tolerant to the IR(ischemic-reperfusion) injury.
~Remote ischemic preconditioning (RIPC) involves the protection of an organ from prolonged ischemia by brief periods of ischemia and reperfusion to a remote organ."
15967511|NCT03130907|Device|Placement of ureteral stent|will randomize groups to either receive a postoperative ureteral stent or not.
15967512|NCT03130894|Other|Plasma TMAO concentration|Plasma TMAO concentration
15967513|NCT03130881|Drug|PLB1003|PLB1003 is a capsule and is administered orally.
15967514|NCT03130868|Other|Characterizing changes in the microbiome|Analyzing the microbial content from stool samples
15967515|NCT03130855|Drug|inferior alveolar nerve block with 4% articaine|an anesthetic technique using 4% articaine anesthetic solution
15967516|NCT03130855|Drug|buccal infiltration with 4% articaine|anesthetic technique using 4% articaine anesthetic solution
15967517|NCT03130842|Drug|Sublingual alprazolam|Patients receive one dose of oral formulation of alprazolam 0.5 mg for sublingual-administered at least 30 minutes before the procedure.
15967518|NCT03130842|Drug|Oral midazolam|Patients receive one dose of intravenous formulation of alprazolam 7.5 mg for oral-administered (in syrup with apple juice) at least 30 minutes before the procedure.
15967519|NCT03130829|Dietary Supplement|Oligo Fucoidan|Oral, twice daily
15967520|NCT03130829|Dietary Supplement|Placebo|Oral, twice daily
15967521|NCT03130816|Biological|allogeneic cord blood transplantation|UCB with total nucleated cell count ≤ 7x108/kg will be used for this clinical trial. Suitable UCB (i.e., containing total nucleated cell count ≥2x107/kg with three or less mismatch among HLA-A, -B, and -DR) will be selected. This criterion was selected upon the rationale that even though minimal HLA mismatch is preferred, prior studies indicate significant effects of UCB therapy for patients with 3 HLA mismatches.
15967522|NCT03130803|Behavioral|Insufficient Sleep|2 days with 5 hour sleep opportunity per day
15967523|NCT03130790|Drug|Varlitinib|300mg, oral tablets, twice daily for 2 weeks. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death.
15967524|NCT03130790|Drug|mFOLFOX6|concurrent oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV in 500 ml 5% dextrose water (D5W) over 120 minutes on Day 1; then 5 Fluorouracil bolus 400 mg/m2 IV on Day 1 followed by continuous infusion 2400 mg/ m2 over 46 hours starting on Day 1) every 2 weeks. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death.
15967525|NCT03130790|Drug|Placebo|oral tablets, twice daily for 2 weeks. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death.
15967526|NCT03130790|Drug|mFOLFOX6|concurrent oxaliplatin 85 mg/m2 and leucovorin 400 mg/m2 IV in 500 ml 5% dextrose water (D5W) over 120 minutes on Day 1; then 5 Fluorouracil bolus 400 mg/m2 IV on Day 1 followed by continuous infusion 2400 mg/ m2 over 46 hours starting on Day 1) every 2 weeks. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death.
15967527|NCT03130777|Device|Edwards Alterra Adaptive Prestent with SAPIEN 3 THV|The Edwards Alterra Adaptive Prestent is designed to reduce the diameter of large irregular RVOTs and provide a circular, semi-rigid landing zone to place an Edwards SAPIEN 3 THV.
15967528|NCT03130764|Drug|Durvalumab|1500 mg, IV over 1 hour Every 4 weeks for 1 year
15967529|NCT03130764|Drug|Tremelimumab|75 mg, IV over 1 hour Every 4 weeks for 4 doses
15967530|NCT03130751|Behavioral|Pocket Coach for AYA with Cancer|The Pocket Coach for AYA with Cancer is a psychosocial intervention to be delivered through a mobile platform. Intervention content is based on Mindfulness Based Stress Reduction (MBSR) and the Resilience in Illness Model [Dr. Joan E. Haase et al] and includes modules on relaxation, mindfulness, cognitions, and self-compassion.
15967531|NCT03130738|Drug|7-Day Miconazole Oil (Miconazole 2%)|7 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)
15967532|NCT03130738|Drug|14-Day Miconazole Oil (Miconazole 2%)|14 days of 2x per day treatment with Miconazole Oil (Active Drug Product 2% Miconazole)
15967533|NCT03130738|Drug|14-Day Placebo - Oil Vehicle|14 days of 2x per day treatment with Placebo - Oil Vehicle, Study Drug base without active ingredient
15967534|NCT03130725|Procedure|Amalgam sealant|Amalgam sealant placed on incipient enamel caries and deep enamel fissures.
15967535|NCT03130725|Procedure|Resin based sealant|Resin based sealant placed on incipient enamel caries and deep enamel fissures.
15967536|NCT03130712|Drug|GPC3-CART cells|Intratumol injection as a local drug delivery pathway, so that more T cells gathered at the tumor site, less T cells to migrated to the normal tissue, thereby enhancing the efficacy of anti-tumor, reducing the potential of side effects. And GPC3-CART is a 2nd CAR, with GPC3 as the target protein, 4-1BB as a co- stimulator
15967537|NCT03130699|Behavioral|Dulce Digital|One-size-fits-all educational text messages, with patient monitoring and transmission of blood glucose values.
15967538|NCT03130699|Behavioral|Dulce Digital-Me (Automated Delivery)|Educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered via automated algorithm-driven messaging, incorporated into existing primary care team processes.
15967539|NCT03130699|Behavioral|Dulce Digital-Me (Medical Assistant)|Educational text messages, with patient monitoring and transmission of blood glucose values, plus personalized goal-setting and tailored feedback delivered by Medical Assistants, incorporated into existing primary care team processes.
15967614|NCT03130023|Device|Pulse Oximeter with ORI|Pulse oximeter that measure Oxygen Reserve Index
15967545|NCT03130608|Other|Inspiratory Muscle Training|Subjects will breath through a hand held valve that has adjustable resistance to strengthen the muscles used for breathing. Subjects will perform the exercise approximately 20-30 minutes, twice a day for 8 weeks.
15967546|NCT03130582|Drug|high-dose etoposide|an epipodophyllotoxin, is one of the most common chemotherapy agents for lymphoma without reciprocal resistance with other kinds of agents.
15967547|NCT03130569|Behavioral|Web-based Module Group|
15967548|NCT03130556|Drug|Glasdegib|Subjects receive 100 mg single dose of ICH glasdegib under fasted condition with washout and then 100 mg single dose of Phase 2 tablet under fasted condition with washout in a randomized fashion. Finally subjects either receive a 100 mg single dose ICH tablet after a high fat, high calorie meal or receive a 100 mg single dose of ICH tablet after repeated daily dosing with rabeprazole.
15967549|NCT03130556|Other|High Fat, High Calorie Meal|A subset of subjects in the study will receive a high fat, high calorie meal prior to being administered a single 100 mg tablet ICH tablet of glasdegib.
15967550|NCT03130556|Drug|Rabeprazole|A subset of subjects will receive repeated daily dosing of 40 mg rabeprazole for 7 days with 100 mg single dose of ICH glasdegib being administered on Day 7.
15967551|NCT03130543|Dietary Supplement|Rice cereal|Standard formula thickened with rice cereal
15967552|NCT03130543|Dietary Supplement|Enfamil AR|Enfamil AR formula
15967553|NCT03130517|Drug|intravenous immunoglobulin|giving intravenous immunoglobulin to neonates included in inclusion criteria in a dose of 0.5-1 gm
15967554|NCT03130504|Drug|17α hydroxy progesterone caproate|where patients will have a 17α hydroxy progesterone caproate intramuscular injection every week starting from 24 weeks of gestation till completed 37 weeks
15967555|NCT03130491|Procedure|Transcatheter Aortic Valve Replacement (TAVR)|placement of a filter to capture and remove embolic material from entering the cerebral vascular circulation during aortic valve replacement
15967556|NCT03130491|Device|EMBLOK filter|Embolic Filter Protection System During TAVR
15967557|NCT03130452|Drug|Lansoprazole 30mg|lansoprazole 30 mg tablet
15967558|NCT03130452|Drug|Amoxicillin 1.0g Tab|Amoxicillin 1.0g tablet
15967559|NCT03130452|Drug|Clarithromycin 500mg|Clarithromycin 500mg tablet
15967560|NCT03130452|Drug|Metronidazole 500 mg|Metronidazole 500 mg tablet
15967561|NCT03130439|Drug|Abemaciclib|Abemaciclib (LY2835219) has been shown in vitro to be a selective ATP-competitive inhibitor of CDK4 and CDK6 kinase activity that prevents the phosphorylation and subsequent inactivation of the Rb tumor suppressor protein, thereby inducing G1 cell cycle arrest and inhibition of cell proliferation.
15967562|NCT03130426|Drug|iGlarLixi|Dose is titrated to achieve fasting normoglycemia
15967563|NCT03130426|Drug|Insulin Glargine|In those who need additional insulin or who cannot tolerate iGlarLixi, insulin glargine will be used. Dose is titrated to achieve fasting normoglycemia.
15967564|NCT03130426|Drug|Metformin|Dose is titrated to 2000 mg daily or maximal tolerated dose
15967565|NCT03130426|Behavioral|Lifestyle therapy|Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving
15967566|NCT03130413|Device|Ambu Aura Gain supraglottic airway|Anesthesia is induced with sevoflurane in oxygen. The anesthesia plane is gradually deepened by increasing the inspired concentration of sevoflurane (2-8%) till the loss of eyelash reflex. After intravenous (IV) cannula is inserted and intravenous fentanyl 1mcg/kg and rocuronium 0.6mg/kg are administered. Use of neuromuscular blocking agent is to minimize the risk of reflex activation of the airway. After 3 minutes, the appropriate size (depending upon body weight) of Ambu Aura Gain is lubricated with water soluble lubricant (KY jelly) is inserted by investigator based on manufacturer recommendation with the patient's head in neutral position. The cuff then is inflated to an intra-cuff pressure of 40 cm H20, measured using a digital cuff pressure monitor.
15967567|NCT03130413|Device|Air-Q supraglottic airway|Anesthesia is induced with sevoflurane in oxygen. The anesthesia plane is gradually deepened by increasing the inspired concentration of sevoflurane (2-8%) till the loss of eyelash reflex. After intravenous (IV) cannula is inserted and intravenous fentanyl 1mcg/kg and rocuronium 0.6mg/kg are administered. Use of neuromuscular blocking agent is to minimize the risk of reflex activation of the airway. After 3 minutes, the appropriate size (depending upon body weight) of Air-Q supraglottic airway is lubricated with water soluble lubricant (KY jelly) is inserted by investigator based on manufacturer recommendation with the patient's head in neutral position. The cuff then is inflated to an intra-cuff pressure of 40 cm H20, measured using a digital cuff pressure monitor.
15967568|NCT03130400|Procedure|Observational gait analysis procedure|All the participants underwent a standard observational procedure: i) diagnosed with knee injuries/arthritis; ii) For KOA, take radiographic examination (x-ray) and take gait analysis on a treadmill in barefoot; iii) For knee injuries, take gait analysis before surgery, the disease of patients was confirmed by surgery (knee arthroscopy); iv)Normal people take an physical examination to avoid other disease;
15967569|NCT03130387|Device|Office Hysteroscope|Diagnosis of C.S niche in patients wit AUB by office hysteroscope
15967570|NCT03130374|Biological|Olfactory mucosa-derived mesenchymal stem cells|Olfactory mucosa-derived mesenchymal stem cells
15967571|NCT03130361|Device|Non-Invasive Ventilation|
15967572|NCT03130348|Drug|Bortezomib|Given SC
15967573|NCT03130348|Drug|Dexamethasone|Given PO
15967574|NCT03130348|Drug|Ibrutinib|Given PO
15967575|NCT03130348|Other|Laboratory Biomarker Analysis|Correlative studies
15967576|NCT03130335|Procedure|BMA Injection|Bone marrow will be aspirated from the iliac crest and injected into the knee.
15967577|NCT03130335|Biological|BMA|Bone marrow will be aspirated from the iliac crest.
15967578|NCT03130322|Other|Imagery and Sleep questionnaires|Participants complete a motor imagery questionnaire to assess their ability to form vivid mental images, as well as sleep questionnaires to control the quality of their sleep
15967615|NCT03130010|Drug|Nefopam or saline|One hour before the end of the operation, the Nefopam group was received 20 mg of nefopam and the saline and the control group was received 20 ml of saline.
15967616|NCT03129997|Dietary Supplement|Gluten test food|Dietary supplement: corn muffins with 7.5g of gluten/muffin Two muffin were blindly administered for 21 days
15967684|NCT03129360|Drug|Levetiracetam|Levetiracetam is an atypical anticonvulsant that is frequently used in children and adults due to its superior tolerability, ease of use and excellent safety profile.
15967579|NCT03130322|Other|MEG recordings (pre-test)|"Participants of the Day group perform two motor tasks (a finger sequential motor task and an adaptation motor task using a trackball) in the MEG, during a pre-test (Day 1 - 9h).
~Task 1: Participants perform an 8-digit motor sequential task where each finger (except the thumb) is used twice. Performance is assessed by using a 4-keys keyboard. Participants are required to keep their fingers on the keys to minimize amplitude are instructed to tap the sequence as few errors as possible Task 2: Participants perform a motor adaptation task requiring scrolling a trackball to superimpose a geometric shape on another one, strictly similar but presented from another angle, as fast as possible."
15967580|NCT03130322|Other|Practice session|Participants of the Day group perform a block of motor imagery practice of the two motor tasks.
15967581|NCT03130322|Other|MEG recordings (Post-test)|Participants perform the two motor tasks in the MEG (post-test, strictly similar to the pre-test)
15967582|NCT03130322|Other|MRI|The registration of the brain anatomy of each participant will be done by MRI 3D / T the week before the first experimental session.
15967583|NCT03130283|Other|Home Hospitalization|Visit every 24 hours
15967584|NCT03130283|Other|Conventional Hospitalization|No intervention
15967585|NCT03130270|Drug|Apatinib mesylate tablet|"Patients with locally recurrent or metastatic nasopharyngeal carcinoma (NPC) after second-line treatment are assigned to receive apatinib mesylate tablet. A treatment cycle was defined as 28 days (4 weeks). The starting dose was 500 mg, orally, qd; tolerance assessment for a cycle, patients with poorly tolerance were treated with low dose (500 mg, qd), and patients with well tolerance were treated with high dose (750 mg, qd). All patients continuous treatment until progression disease or non-tolerated toxicity.
~Note: good tolerance was defined that no grade 3/4 hematology or/and non hematologic side effects occurred within 4 weeks after initiation treatment; poor tolerance was defined that grade 3/4 hematology or/and non hematologic side effects appeared within 4 weeks after initiation treatment."
15967586|NCT03130257|Diagnostic Test|Clinic Blood Pressure Measurement|Participants will be asked to check their blood pressure once within the subsequent three weeks.
15967587|NCT03130257|Diagnostic Test|Home Blood Pressure Measurement|Participants will receive a validated upper-arm home blood pressure monitor and asked to two measurements in the morning and two in the evening for at least 5 days over three weeks.
15967588|NCT03130257|Diagnostic Test|Kiosk Blood Pressure Measurement|Participants will be asked to use a validated blood pressure kiosk in their clinic or local pharmacy to measure their blood pressure three times on three separate days over three weeks.
15967589|NCT03130257|Diagnostic Test|24-hour Ambulatory Blood Pressure Monitoring (Reference Standard)|Participants will be asked to wear an arm cuff and ambulatory blood pressure monitor for 24 hours, with measurements taken every 30 minutes during the day and every 60 minutes at night.
15967590|NCT03130244|Device|Magnet Anastomosis System|The MAS will be placed using an endoscope in the duodenum and and laparoscopically into ileum. A compression anastomosis will be created in each of the patients and the diversion of enteral flow from the duodenum to ileum treats Type 2 diabetes.
15967591|NCT03130244|Drug|Best Medical Management|The best medical management for the patients in this arm will be decided by the endocrinologist based on protocol parameters.
15967592|NCT03130218|Other|Peppermint oil aromatherapy|Aroma therapy with peppermint oil administered with presoaked diffuser and bag.
15967593|NCT03130205|Procedure|Core Needle Biopsy|Core Needle Biopsy is performed from liver metastasis.
15967594|NCT03130205|Radiation|Computed Tomography|Computed Tomography
15967595|NCT03130205|Radiation|18F-FDG-PET|18F Fluorodeoxyglucose Positron emission tomography
15967596|NCT03130205|Procedure|Phlebotomy|3 EDTA tubes drawn from peripheral vein
15967597|NCT03130205|Genetic|Molecular genetic analysis|Performed on biomaterial from peripheral vein and core needle biopsy
15967598|NCT03130179|Drug|Nicorette Strongmint lozenge 4 mg|A single dose of one Nicorette lozenge 4mg lozenge administrated orally to slowly dissolve in the mouth.
15967599|NCT03130179|Drug|Niquitin MiniMint lozenge 4 mg|A single dose of one Niquitin Minimint lozenge 4mg administrated orally to slowly dissolve in the mouth.
15967600|NCT03130166|Procedure|Intracorporeal anastomosis|Use of intracorporeal anastomosis technique
15967601|NCT03130166|Procedure|Extracorporeal anastomosis|Use of the conventional extracorporeal anastomosis technique
15967602|NCT03130153|Drug|Aspirin Powder|Aspirin powder to be dissolved in water and to be used as mouthwash twice daily for 7 days after tooth extraction.
15967603|NCT03130153|Drug|Normal saline|Normal saline to be used as mouthwash twice daily for 7 days after tooth extraction among non-hypertensive subjects.
15967604|NCT03130140|Procedure|Macroscopic on-site evaluation|Macroscopic on-site evaluation: any aspirated material on a glass slide for inspection of the presence of a macroscopic visible core (MVC). Length of MVC will be measured to determine the adequacy of that puncture.
15967605|NCT03130140|Other|Control|Conventional EUS-FNA
15967606|NCT03130127|Drug|Terlipressin|According to the current practice guidelines and consensus, terlipressin is the standard treatment option for acute variceal bleeding in liver cirrhosis.
15967607|NCT03130114|Drug|Azithromycin|Participants will receive rehydration, dietary counseling, one 20 mg tablet of zinc per day and 10 mg (0.35 ml) / kg of azithromycin syrup per day, for three days
15967608|NCT03130114|Other|Placebo|Participants will receive rehydration, dietary counseling, one 20 mg tablet of zinc per day and 0.25 ml / kg of placebo drug syrup per day, for three days
15967609|NCT03130101|Other|Change in their basal insulin rate|Individual with type 1 diabetes on insulin pump therapy typically lower their basal insulin delivery for exercise. This study will compare 3 common strategies of basal insulin reductions for 75 minutes of aerobic exercise.
15967610|NCT03130088|Other|no intervention planed|no intervention planed
15967611|NCT03130062|Other|Exercise|The following muscular clusters were exerted: latissimus dorsi, deltoid, pectoralis major , triceps brachialis, biceps brachialis, quadriceps, hamstring, thigh adductor muscles, thigh abductor muscles and gastrocnemius.
15967612|NCT03130049|Procedure|Popliteal plexus block|10 mL Marcain-adrenalin 5 mg/mL + 5 microgram/mL. Ultrasound-guided injection into the distal part of the adductor canal
15967613|NCT03130036|Other|[11C]Acetoacetate[18F]Fluorodeoxyglucose positron emission tomography scan|A PET scan to measure uptake of acetoacetate and glucose in the brain will be administered to all participants enrolled in the study
15967617|NCT03129984|Device|Mandibular movement tracking|Patients wore the Brizzy device while sleeping. Mandibular movements (A mid-sagittal mandibular movement magnetic sensor measured the distance in mm between two parallel, coupled, resonant circuits placed on the forehead and chin.) were tracked during sleep.
15967618|NCT03129971|Procedure|conventional surgery|Patients with atrophic nonunion of femoral shaft fractures are equally and randomly assigned to control group, which received conventional surgery.
15967619|NCT03129971|Procedure|autologous platelet-rich plasma|Patients with atrophic nonunion of femoral shaft fractures are equally and randomly assigned to experimental group, which are injected with autologous platelet-rich plasma on the basis of conventional surgery.
15967620|NCT03129945|Drug|Nifedipine|Subjects will be given nifedipine 10mg orally and repeated every 20 minutes for a maximum dose of 30mg in the first hour followed by 20mg every 6 hours for the first 48 hours.
15967621|NCT03129945|Drug|Indomethacin|Those randomized to indomethacin will be given 100mg orally as a loading dose followed by 50mg every 6 hours for the first 48 hours of treatment.
15967622|NCT03129932|Dietary Supplement|gluten phase|2 cakes containing 9g of vital gluten/each will be consume during the 4 weeks of intervention
15967623|NCT03129932|Dietary Supplement|placebo phase|2 cakes without gluten will be consume during the 4 weeks of intervention
15967624|NCT03129919|Device|Carriere SLX® (Passive self-ligating braces)|Changes in the inclination of the incisors, expansion of the arches at the end of the alignment and leveling phase of the orthodontic treatment
15967625|NCT03129919|Device|Empower® (Interactive self-ligating braces)|Changes in the inclination of the incisors, expansion of the arches at the end of the alignment and leveling phase of the orthodontic treatment
15967626|NCT03129906|Dietary Supplement|Gluten|
15967627|NCT03129906|Dietary Supplement|Rice protein|
15967628|NCT03129893|Device|Cuffed tracheal tubes|Cuffed tracheal tube with an anatomically designed high volume - low pressure tube cuff, with a recommendation chart for tube size selection available for pediatric anesthesia
15967629|NCT03129880|Behavioral|Weekly Voice Therapy|Participants will be randomized to receive weekly voice therapy
15967630|NCT03129880|Behavioral|Intensive Voice Therapy|Participants will be randomized to receive multiple sessions of voice therapy in one day.
15967631|NCT03129867|Drug|Ticagrelor|Ticagrelor 60mg or 90 mg as routine use of each Center
15967632|NCT03129854|Device|prostate cryotherapy|prostate cryotherapy added to experimental group within 6 months of ADT
15967633|NCT03129841|Behavioral|Early dinner+Diet|Subjects are asked to eat dinner meals between 7:00- 7:30 PM in the ED group, while they are on a multidisciplinary weight loss plan for 12 weeks.
15967634|NCT03129841|Behavioral|Late dinner+Diet|Subjects are asked to eat their dinner meal between 10:30-11:00PM, while they are on a multidisciplinary weight loss plan for 12 weeks.
15967635|NCT03129828|Drug|Ibrutinib and Bortezomib + R-CHOP|A pre-phase therapy with Prednisone 100 mg p.o. is mandatory from d-4 until d0. Patients receive 6 cycles of a combined immunochemotherapy with the anti-CD20 antibody Rituximab (375 mg/m2 d0 or d1) together with 6 cycles of a chemotherapy consisting of Cyclophosphamide (750 mg/m2 d1), Doxorubicin (50 mg/m2 d1), Vincristine 1 mg absolute d1), Prednisone (100 mg absolute p.o. d1-5) and Bortezomib s.c. (1.3 mg/m2 C1 on d3 and 8, other cycles d1 and d8), in 21-day intervals and Ibrutinib 560 mg p.o. for individuals < 65 years and 420 mg p.o. for individuals ≥ 65 years (from d6 of C1 until d21 of C6), followed by two additional 3-week cycles of Rituximab (375 mg/m2).
15967636|NCT03129789|Other|Volumetric Bladder Ultrasound Training|teaching residents to perform bladder volumetric ultrasound
15967637|NCT03129776|Drug|Hyperpolarized 13C-Pyruvate|The new imaging method being tested is called Metabolic MRI, which provides pictures of the metabolism occurring within cancer cells. It also involves injection of a contrast agent, Hyperpolarized Pyruvate (13C) Injection, into the arm vein. The participants will be injected with the study drug at a dose of 0.43 ml/kg and then receive a MRI scan.
15967638|NCT03129776|Drug|18F-FDG|18F-FDG is a radiopharmaceutical used in medical imaging. The uptake of 18F-FDG by tissues is a marker for the tissue uptake of glucose, which is correlated with certain types of tissue metabolism, particularly in cancer cells. The participant will be injected with the study drug at a dose of 5 MBq/kg to a maximum of 500 MBq and then receive a PET scan.
15967639|NCT03129763|Behavioral|60mmHg capsule pressure expansion|With a self-made apparatus composed of a spring-loaded sphygmomanometer and a disposable three-way pipe, the capsule pressure is measured. Increasing capsule pressure till 60mmHg.
15967640|NCT03129763|Behavioral|70mmHg capsule pressure expansion|With a self-made apparatus composed of a spring-loaded sphygmomanometer and a disposable three-way pipe, the capsule pressure is measured. Increasing capsule pressure till 70mmHg.
15967641|NCT03129763|Behavioral|80mmHg capsule pressure expansion|With a self-made apparatus composed of a spring-loaded sphygmomanometer and a disposable three-way pipe, the capsule pressure is measured. Increasing capsule pressure till 80mmHg.
15967642|NCT03129763|Behavioral|90mmHg capsule pressure expansion|With a self-made apparatus composed of a spring-loaded sphygmomanometer and a disposable three-way pipe, the capsule pressure is measured. Increasing capsule pressure till 90mmHg.
15967643|NCT03129763|Behavioral|100mmHg capsule pressure expansion|With a self-made apparatus composed of a spring-loaded sphygmomanometer and a disposable three-way pipe, the capsule pressure is measured. Increasing capsule pressure till 100mmHg.
15967644|NCT03129750|Device|Drug Coated Balloon|Peripheral PTA with a drug coated balloon
15967645|NCT03129737|Procedure|Mitral valve surgery|Mitral valve repair is preferred whenever technically feasible over valve replacement. Annuloplasty may be used as sole therapy or in conjunction with other repair maneuvers to support the reconstruction and reinforce the annulus as well as prevent future annular dilatation. The mitral regurgitation secondary to myxomatous degeneration is prolapse of the middle scallop of the posterior leaflet result from chordal rupture or chordal elongation. Quadrangular resection of the involved middle scallop of the posterior leaflet combined with a posterior mitral annuloplasty is the best way to handle this situation. Chordae replacement could be used also to treat flail/prolapse of the anterior leaflet. Annuloplasty is always doing in mitral valve repair to stabilize and reshape the annulus.
15967682|NCT03129399|Device|McGrath MAC video laryngoscope|nasal intubation with McGrath MAC video laryngoscope Device after general anesthesia induction
15967683|NCT03129373|Device|Cryogenic treatment of warts|Treatment of common and plantar wart by cryotherapy treatment.
15967646|NCT03129737|Procedure|Tricuspid valve annuloplasty|Depending on the extent of the valve disease, there is the possibility to perform valve repair. In mitral valve reference center the rate of repair will reach 100%. In many patients with mitral valve regurgitation, tricuspid valve will be insufficient or the annulus dilated. Tricuspid annuloplasty ring will be helpful to treat dilation by reshaping, or to treat the regurgitant diseases. The ring will be secured and sutured to the native annulus by U-stitches.
15967647|NCT03129711|Other|glazed Celtra Duo|zirconia reinforced lithium silicate
15967648|NCT03129711|Other|IPS Empress CAD|Standard etchable glass ceramic for laminate veneers
15967649|NCT03129698|Drug|Apatinib|Apatinib 250mg daily
15967650|NCT03129685|Procedure|HALED|This is attained via a laparotomy involves isolation of the arterial blood supply of the tumor-containing liver lobe (the ipsilateral hepatic artery as well as the extrahepatic arterial collaterals) while preserving the feeding veins.
15967651|NCT03129672|Procedure|allograft arthrodesis of ankle|patients that underwent trought a block resection of a malignant tumor of the distal tibia and reconstruction with allograft arthrodesis
15967652|NCT03129659|Diagnostic Test|Coronary CT Angiography|Coronary CT angiography
15967653|NCT03129646|Drug|Miltefosine|Miltefosine 10mg and 50mg capsules
15967654|NCT03129646|Drug|Paromomycin|Paromomycin sulfate equiv to 750mg paromomycin / 2ml amp
15967655|NCT03129646|Drug|Sodium stibogluconate|Sodium stibogluconate 33% 30 ml inj.
15967656|NCT03129633|Other|Intervention group|One-on-one contact with a promotor(a) over the 6 month intervention.
15967657|NCT03129594|Diagnostic Test|plasma glucagon-like peptide-1 levels|The plasma GLP-1 levels was determined by enzymatic assays.
15967658|NCT03129581|Behavioral|Dietary Counseling|Counseling to only eat during a restricted amount of time.
15967659|NCT03129568|Biological|CDC infusion|Injection of CDCs (0.3 million per kg of body weight).
15967660|NCT03129555|Drug|Dabigatran Etexilate Oral Capsule|After cluster randomization, the cluster will use dabigatran to all their patients with venous thromboembolism when possible for six months. Hereafter the cluster will use the other three NOACs for six months one at the time. It is the clusters and not the patient that are randomized.
15967661|NCT03129555|Drug|Rivaroxaban Oral Tablet|After cluster randomization, the cluster will use rivaroxaban to all their patients with venous thromboembolism when possible for six months. Hereafter the cluster will use the other three NOACs for six months one at the time. It is the clusters and not the patient that are randomized.
15967662|NCT03129555|Drug|Edoxaban Oral Tablet|After cluster randomization, the cluster will use edoxaban to all their patients with venous thromboembolism when possible for six months. Hereafter the cluster will use the other three NOACs for six months one at the time. It is the clusters and not the patient that are randomized.
15967663|NCT03129555|Drug|Apixaban Oral Tablet|After cluster randomization, the cluster will use apixaban to all their patients with venous thromboembolism when possible for six months. Hereafter the cluster will use the other three NOACs for six months one at the time. It is the clusters and not the patient that are randomized.
15967664|NCT03129542|Drug|Midodrine Hydrochloride 10 milligrams|Three doses taken every 8 hours.
15967665|NCT03129542|Drug|Placebo capsule|Three doses taken every 8 hours.
15967666|NCT03129529|Device|Focused shock wave|The outcome evaluation include ankle range of motion (ROM), modified Ashworth scale (MAS),modified Tardieu scale (MTS), baropodometric measurement, and gait speed.
15967667|NCT03129529|Device|Radial shock wave|The outcome evaluation include ankle range of motion (ROM), modified Ashworth scale (MAS),modified Tardieu scale (MTS), baropodometric measurement, and gait speed.
15967668|NCT03129516|Behavioral|Determining Imaginary levels|Determining the motor imaginary: internal visual, external visual and kinesthetic imagery
15967669|NCT03129490|Drug|Dabigatran Etexilate Oral Capsule|After cluster randomization, the cluster will use dabigatran to all their patients with non-valvular atrial fibrillation when possible for six months. Hereafter the cluster will use the other three NOACs for six months one at the time. It is the clusters and not the patient that are randomized.
15967670|NCT03129490|Drug|Rivaroxaban Oral Tablet|After cluster randomization, the cluster will use rivaroxaban to all their patients with non-valvular atrial fibrillation when possible for six months. Hereafter the cluster will use the other three NOACs for six months one at the time. It is the clusters and not the patient that are randomized.
15967671|NCT03129490|Drug|Edoxaban Oral Tablet|After cluster randomization, the cluster will use edoxaban to all their patients with non-valvular atrial fibrillation when possible for six months. Hereafter the cluster will use the other three NOACs for six months one at the time. It is the clusters and not the patient that are randomized.
15967672|NCT03129490|Drug|Apixaban Oral Tablet|After cluster randomization, the cluster will use apixaban to all their patients with non-valvular atrial fibrillation when possible for six months. Hereafter the cluster will use the other three NOACs for six months one at the time. It is the clusters and not the patient that are randomized.
15967673|NCT03129477|Procedure|Telemonitoring in noninvasive ventilation|Compare telemonitoring to conventional monitoring to optimize Ventilation
15967674|NCT03129464|Device|Cold therapy via reusable cold gel pack|Patients in the experimental group will be asked to apply cold therapy to their abdominal incisions every 6 hours for the first 72 hours following their surgery (total laparoscopic hysterectomy). Cold therapy will be applied via a reusable cold gel pack.
15967675|NCT03129451|Diagnostic Test|Microbiome specimens in stool|Analyzing Microbiome specimens in stool
15967676|NCT03129438|Diagnostic Test|continuous EEG (cEEG)|differential use of continuous versus routine EEG
15967677|NCT03129438|Diagnostic Test|routine EEG (rEEG)|differential use of continuous versus routine EEG
15967678|NCT03129425|Behavioral|ReNACE Psychoeducational Intervention|9 sessions in groups of 15-20 people at most so as to promote reflection and facilitate the interchange of opinions between participants about issues of interest from their day to day experience of coping with Parkinson's disease.
15967679|NCT03129425|Other|General Educational Program|5 sessions in groups of 15-20 people
15967680|NCT03129412|Radiation|radical radiotherapy|radical radiotherapy for primary tumors were given. Appropriate treatments for olio-metastatic lesions will be assigned to those who got PR,SD after chemotherapy.
15967681|NCT03129399|Device|King Vision video laryngoscope|nasal intubation using King Vision video laryngoscope Device after general anesthesia induction
15967685|NCT03129347|Drug|Nalmefene|Comparing pharmacokinetics of intranasal nalmefene to intramuscular nalmefene
15967686|NCT03129334|Behavioral|LST Middle School Online|The adapted intervention will (1) utilize both online e-learning module (self-guided) and classroom-based sessions (facilitator led) to address PDA and concurrent ATOD abuse; (2) positively change social norms and challenge positive expectancies regarding PDA and ATOD abuse; (3) discourage diversion of prescription medications; (4) enhance protective factors by building social and self-regulation skills through interactive learning and behavioral rehearsal scenarios; and (5) incorporate booster sessions.
15967687|NCT03129321|Drug|Econazole Nitrate Cream, 1%|
15967688|NCT03129321|Drug|Placebo|
15967689|NCT03129308|Diagnostic Test|Blood Sampling|4.5ml of blood will be collected and analyzed for the presence of cutaneous autoantibodies (indirect immunofluorescence, desmoglein1/3, BPAG1/2, collagenVII, and envoplakin ELISA)
15967690|NCT03129295|Drug|MPC-SHRC|Oral tablet four times a day for 3 days
15967691|NCT03129295|Drug|Placebo Oral Tablet|Oral tablet four times a day for 3 days
15967692|NCT03129282|Other|Home-based Metacognitive Therapy (Home-MCT)|Home-based metacognitive therapy (Home-MCT) is a facilitated self-help manual comprising six modules which participants will complete at their own pace over approximately 6 weeks. Participants will have an initial appointment with a Home-MCT trained cardiac rehabilitation staff members (face to face or by telephone). In addition, they will receive two telephone calls from trained cardiac rehabilitation staff members over the course of the intervention to offer support with completing the modules of the self-help manual.
15967693|NCT03129269|Procedure|MRI and PET scan|Neuroimaging with MRI and PET scan Amyloid tracer : For PET-scans, 4 MBq/kg of [18F]AV-45 will be injected into each subject in an intravenous bolus.
15967694|NCT03129256|Drug|Apatinib Mesylate tablet combined with S-1 capsules|Oral use with low-dose Apatinib combined with S-1 until disease progression
15967695|NCT03129243|Diagnostic Test|Sperm DNA integrity by flow cytometry|flowcytometric test where sperm DNA breaks are evaluated indirectly through the DNA denaturability. The assay measures the susceptibility of sperm DNA to acid-induced DNA denaturation in situ, followed by staining with the fluorescence dye acridine orange. By using a flow cytometer 5.000-10.000 sperm can be analyzed within few seconds and thus provide a less subjective result compared to the World health organization analysis where only 1-300 cells are analyzed.
15967696|NCT03129230|Procedure|free nonvascularized fibula autograft|Sixteen pediatric patients before epiphyseal closure were treated with free nonvascularized fibula autograft after resections of tumor-like lesions in the femoral neck between Aug. 2012 and Sep. 2016. All the patients were given supplementary skeletal traction through supracondyle of femur for 4 weeks to 6 weeks after the resections.
15967697|NCT03129204|Behavioral|SAF-T|The Rosenzweig Center for Rapid Recovery has recently developed an adaptation of their Accelerated Resolution Therapy (ART) for psychological trauma and depression, called Sensation Awareness Focused Training (SĀF-T), as an approach to rapidly eliminate negative biological sensations of stress. SĀF-T is designed to elicit a calming response; interrupt negative thoughts, negative feelings, and negative behaviors; and ultimately serve as a self-management stress reduction tool for individuals.
15967698|NCT03129191|Device|Non-invasive bone conduction hearing aid A|The intervention is a non-invasive bone conduction hearing device which is retained on the patient's head with an elastic headband.
15967699|NCT03129191|Device|Non-invasive bone conduction hearing aid B|The intervention is a non-invasive bone conduction hearing device which is retained on the patient's head with an adhesive adapter that is placed behind the auricle.
15967700|NCT03129178|Dietary Supplement|Concentrated beetroot juice|Acute and chronic supplementation of beetroot juice.
15967701|NCT03129165|Other|Screening and prevention of CVD|"Drug: Pharmacological control of risk factors in agreement with primary physicians.
~Behavioral: Smoking cessation / Control of depression and anxiety / Nutritional counseling / Motivation for physical activity.
~Social: Social worker care."
15967702|NCT03129139|Drug|Minnelide™Capsules|Minnelide™ is a water soluble disodium salt variant of triptolide an heat shock protein (HSP) inhibitor.
15967704|NCT03129113|Drug|Maraviroc|1:1:1:1 randomisation to one of four arms for 48 weeks
15967705|NCT03129113|Drug|Metformin|1:1:1:1 randomisation to one of four arms for 48 weeks
15967706|NCT03129100|Drug|Ixekizumab|Administered SC
15967707|NCT03129100|Drug|Placebo|Administered SC
15967708|NCT03129087|Behavioral|Vocal rest versus vocalization|A comparison of one hour of vocal rest versus continuous vocalization after botulinum toxin injection
15967709|NCT03129074|Drug|Varlitinib|everyday
15967710|NCT03129074|Drug|Capecitabine|from Day 1 to Day 14 followed by 7-day of rest period, every 21 days.
15967711|NCT03129061|Drug|[18F]F-AraG PET Scan, baseline + post anti-PD-1 therapy.|"Baseline: Blood sampling, tumor biopsy, [18F]F-AraG PET/CT scan within two weeks prior to standard of care anti-PD-1 therapeutic dose.
~Anti PD-1 per standard of care
~Blood sampling and tumor biopsy within 2-3 weeks after first anti-PD-1 SOC dose.
~[18F]F-AraG PET/CT scan 6 - 12 weeks post first anti-PD-1 dose."
15967712|NCT03129061|Drug|[18F]F-AraG PET Scan, baseline + post anti-PD-1 therapy.|"Baseline: Blood sampling, tumor biopsy, [18F]F-AraG PET/CT scan within two weeks prior to treatment.
~Anti PD-1, single dose
~Blood sampling, tumor biopsy and [18F}F-AraG PET/CT scan within 2-3 weeks after single dose of anti-PD-1 treatment. For patients having surgical resection, biopsy will be immediately prior to resection or from sample of resection."
15967713|NCT03129048|Behavioral|MedDiet|"Research subjects will be randomly assigned to one of three intervention groups.
~The MedDiet-A group will learn about and how to adhere to the Mediterranean Diet. Over the course of 8 months, they will receive twenty-two classes 60-minute in length.
~The MedDiet-WL group will learn about the Mediterranean Diet, how to adhere to is and engage in lifestyle choices like exercising and eating fewer calories so that they will loose weight. Over the course of 8 months they will receive 22 classes, each 90 minutes in length.
~The Typical Diet Control group will be asked to maintain current eating and activity patterns over the course of the 14 month study."
15967714|NCT03129035|Procedure|Cesarean hystrectomy|Upper segment cesarean section followed by fetal extraction and cesarean hystrectomy started without any attempts of placental removal
15967779|NCT03128541|Diagnostic Test|Ultrasound spine|A ultrasound of the lumbar spine of each patient will be performed in both positions to identify vertebral levels
15967856|NCT03128034|Radiation|Total-Body Irradiation|Undergo TBI
15967715|NCT03129035|Procedure|Internal iliac artery ligation|The retroperitoneal space was entered at the level of common iliac bifurcation and followed to the point of division into the external and internal iliac arteries. The ureter was retracted medially by gentle finger dissection, revealing the retroperitoneal anatomy. The fat and loose connective tissue around the IIA and vein were removed and a right-angle clamp was passed beneath the IIA from the lateral to the medial side approximately 4 cm distal to its origin. Using an absorbable suture, the IIA was ligated doubly in all cases . Pulsations of the external iliac and femoral arteries were identified after internal iliac ligation. The procedure was then repeated on the other side
15967716|NCT03129022|Procedure|epidural anaesthesia|Women requesting epidural analgesia received a bolus of intravenous infusion of lactated Ringer's solution before initiation of the procedure. An 18-gauge Tuohy needle and closed-tip clear catheter with three lateral orifices were used in the sitting or lateral position, with a loss-of-resistance to air technique. Epidural catheters were routinely inserted 5-6 cm inside the epidural space. A test dose of 2 ml of lidocaine 2% was initiated followed by a loading dose of 10 ml of bupivacaine 0.25%. Analgesia is maintained throughout labor using 0.125% bupivacaine with fentanyl 2 μg/ml with patient-controlled epidural analgesia by means of a continuous epidural infusion (8 ml/h basal rate) and patient-controlled boluses (3 ml each) with 20-minlock-out intervals
15967717|NCT03129009|Drug|Total intravenous anesthesia group|Total intravenous anesthesia induced with sufentanil,etomidate,cisatracurium and midazolam and maintained with propofol,cisatracurium and remifentanil target controlled infusion
15967718|NCT03129009|Drug|Balanced anesthesia group|Balanced anesthesia induced with sufentanil,etomidate,cisatracurium and midazolam and maintained with cisatracurium and remifentanil target controlled infusion and sevoflurane inhalation
15967719|NCT03128996|Drug|RIC regimen|Days -60 to -21: hydroxyurea (30mg/kg/day po) >6hrs prior to 1st dose: alemtuzumab (3mg IV) Day -21: alemtuzumab (10mg IV or S/C) Day -20: alemtuzumab (15mg IV or S/C) (10mg if < 10kg) Day -19: alemtuzumab (20mg IV or S/C) (10mg if < 10kg) Days -8 to -4: fludarabine (30mg/m2/day IV) Day -4: thiotepa (8mg/kg IV) Day -3: melphalan (140mg/m2) Days -2 to -1: rest days/no therapy Day 0: bone marrow transplant
15967720|NCT03128996|Drug|GVHD prophylaxis regimen|Day +3 to +4: cyclophosphamide (50mg/kg/day IV) Day +5: Start of tacrolimus & Start of mycophenolate mofetil (MMF) Days +30, +60, and +90: abatacept (IND) (10mg/kg/day IV)
15967721|NCT03128983|Device|Participants wear a sensor bracelet for collecting physiological data and conducted urine tests to estimate the day of ovulation|
15967722|NCT03128970|Other|synchronizing blastocysts|transferring frozen/thawed a synchronized blastocysts at hatching stage into female uterus.
15967726|NCT03128931|Device|Pediatric SedLine forehead EEG sensor|Pediatric EEG sensor.
15967727|NCT03128905|Drug|Colchicine opocalcium 1mg|"International non-proprietary name: Colchicine
~Molecule owner: Mayoly-Spindler Laboratory, 1mg scored tablet for oral administration, authorized 03/02/1995.
~Composition :
~Active principle : Crystallized colchicine Excipients: Erythrosine aluminium lake, lactose, saccharose, magnesium stearate and povidone."
15967728|NCT03128905|Drug|Prednisone : Cortancyl 20mg|"International non-proprietary name: Prednisone
~Molecule owner : SANOFI AVENTIS France 20 mg scored tablet for oral administration, authorized since 02/05/1990, generic drug available.
~Composition :
~Active principle : Prednisone Excipients: Maize starch, lactose, talc, magnesium stearate."
15967729|NCT03128892|Device|Oxygen Reserve Index - RD Lite Sensors|
15967730|NCT03128879|Drug|Ibrutinib|Given PO
15967731|NCT03128879|Drug|Venetoclax|Given PO
15967732|NCT03128866|Procedure|Hemipelvectomy|Undergo hemipelvectomy
15967733|NCT03128866|Drug|Tranexamic Acid|Given IV
15967734|NCT03128853|Device|Rad-67 and DCI Mini Sensor|
15967735|NCT03128827|Device|RAM sensor|Acoustic Respiration Monitor
15967736|NCT03128801|Procedure|Global Stretching Program|Participants will be submitted to a GSP in self-management postures weekly for 40 minutes session conducted by one one physical therapist, certified to use the technique (Stretching Global Active). The GSP will last for a period of 8 weeks. The protocol is based on the study of Lawand et al (2015) who used all postures global therapeutic stretching. The investigators will use six self-management postures in a standardized manner, each of which will last for 10 to 20 minutes.
15967737|NCT03128801|Procedure|Stabilization Exercises|The exercise protocol and criteria to increase exercise progression was previously described by Hicks et al (2005). It will be directed by a single therapist one to one session based on specific criteria (being able to maintain muscle contraction eight seconds during 30 repetitions in bilateral exercises or during 20 repetitions for unilateral exercises). Each session will be conducted weekly for 40 minutes.
15967738|NCT03128788|Procedure|thoracic epidural catheterization|thoracic epidural catheterization thoracic epidural catheterization for the management of postoperative pain
15967739|NCT03128775|Behavioral|Nudge|"School lunchrooms are the central place of modifications regarding food consumption, where the following strategies will be conducted:
~arrange the fruits served in the school lunch in a prominent position, in containers of bright and contrasting colors to serve them;
~Create creative names for food served at meals will be created by the students used on displays at canteen tables, posters on the way of the cafeteria and at a menu outside the cafeteria.
~To encourage water consumption, footprints that lead to them to water fountains will be painted on the floor. To stimulate physical activity, several sports equipment (basketball hoops, volleyball nets, balls, ropes, shuttlecock and a lot of toys) will be available for use in the school sports court. The courts will be renovated and footsteps painted in order to nudging students to the sports equipment."
15967780|NCT03128528|Drug|Empagliflozin 10mg|"Each patient, after the run-in/wash-out phase, will be randomly assigned in a doubleblind fashion to one of the two treatment sequences according to a randomisation list.
~and provided by the sponsor."
15967781|NCT03128528|Drug|Placebo Oral Tablet|"Each patient, after the run-in/wash-out phase, will be randomly assigned in a doubleblind fashion to one of the two treatment sequences according to a randomisation list.
~and provided by the sponsor."
15967782|NCT03128515|Drug|Hydroxyurea|Administered once a day in tablet form (100mg or scored 1000mg) for 24 months
15967740|NCT03128775|Behavioral|Primary prevention|Classroom-based educational activities based on an earlier study, called PAPPAS, which was developed in the same city and constituted a school-based intervention with the objective of reducing the consumption of sweetened beverages and biscuits and increase the consumption of fruits, vegetables and beans. Activities will be facilitated by trained research assistants. Printed instructions and orientations on the facilitation process will support the assistants' efforts. The activities will require 20 to 30 minutes, and teachers will be encouraged to reiterate the message during their lesson. The goal is to promote ten one-hour sessions of activity for each class.
15967741|NCT03128775|Behavioral|Primary prevention + nudge|This group will receive both primary prevention and nudge activities. At school lunchrooms, the fruits served in the school lunch will be put in a prominent position, in containers of bright and contrasting colors to serve them; create creative names for food served at meals will be created by the studentes, footprints that lead to them to water fountains will be painted on the floor. Several sports equipment (basketball hoops, volleyball nets, balls, ropes, shuttlecock and a lot of toys) will be available for use in the schools sport court. Also, classroom-based educational activities based on an earlier study, called PAPPAS, will be held. The activities will require 20 to 30 minutes, and teachers will be encouraged to reiterate the message during their lesson. The goal is to promote ten one-hour sessions of activity for each class.
15967742|NCT03128762|Biological|ILC2 levels in blood|The levels of circulating ILC2 cells relative to other lymphocytes will be determined via flow cytometry
15967743|NCT03128749|Behavioral|Mindfulness Based Intervention|"The mindfulness based intervention protocol used in this project is adapted from the original and validated MBCT program for depression (Segal, Williams & Teasdale, 2002). Two more sessions, focused on obsessive symptoms specfic to each participant, will be included. Those two sessions will be adapted from the manual The Mindfulness Workbook for OCD (Hershfield and Corboy, 2013)."
15967744|NCT03128749|Drug|Treatment as Usual|The psychiatric referee will follow OCD guidelines modifying or potentiating drug treatments if needed.
15967745|NCT03128736|Drug|Esomeprazole group|Esomeprazole 40mg qd
15967746|NCT03128736|Drug|Dexlansoprazole group|Dexlansoprazole 60mg qd
15967747|NCT03128723|Device|Acne Mask|The light therapy acne mask contains a combination of red and blue light-emitting diodes. The device is applied once daily, in the evening for a duration of 10 minutes.
15967748|NCT03128697|Behavioral|Satiating diet|
15967749|NCT03128697|Behavioral|Control diet|
15967750|NCT03128684|Other|Small Green Lentil Muffin|Consumption of small green lentil muffin; consumption of ad libitum pizza test meal after 180 minutes
15967751|NCT03128684|Other|Split Red Lentil Muffin|Consumption of split red lentil muffin; consumption of ad libitum pizza test meal after 180 minutes
15967752|NCT03128684|Other|Wheat Muffin|Consumption of wheat muffin; consumption of ad libitum pizza test meal after 180 minutes
15967753|NCT03128684|Other|Small Green Lentil Chili|Consumption of small green lentil chili; consumption of ad libitum pizza test meal after 180 minutes
15967754|NCT03128684|Other|Split Red Lentil Chili|Consumption of split red lentil chili; consumption of ad libitum pizza test meal after 180 minutes
15967755|NCT03128684|Other|Rice Chili|Consumption of rice chili; consumption of ad libitum pizza test meal after 180 minutes
15967756|NCT03128671|Behavioral|FAVoR Intervention|The FAVoR intervention includes a set of 8 scripted recorded messages, no longer than 2 minutes long, includes subject's name, uses simple terms, and is written at a 5th grade reading level. Messages include information about the critical care environment, the visual and auditory stimuli to be expected, and the availability of providers and family.
15967757|NCT03128658|Diagnostic Test|Thromboelastography|Thromboelastography (TEG) tests for parameters related to efficiency of blood coagulation. The parameters are: reaction time (R value), the K value, the angle and the maximum amplitude (MA)
15967758|NCT03128658|Diagnostic Test|Computational model|The computational whole-patient systems model is a multiscale, multi-compartment model whose state-space is defined by a very large and heterogeneous set of variables as well as a large number of input parameters. The model will be integrated in time for various initial trauma conditions in an attempt to determine whether the model can be predictive, and help us discover new variables that are more predictive of clinical outcomes than those employed in current clinical protocols.
15967759|NCT03128645|Device|Abdominal Corset|The patient's colonoscopy procedure in group 2 after randomization will be performed with the abdominal corset.
15967760|NCT03128619|Procedure|Biopsy of Breast|Undergo biopsy
15967761|NCT03128619|Drug|Copanlisib|Given IV
15967762|NCT03128619|Other|Laboratory Biomarker Analysis|Correlative studies
15967763|NCT03128619|Drug|Letrozole|Given PO
15967764|NCT03128619|Drug|Palbociclib|Given PO
15967765|NCT03128619|Other|Pharmacological Study|Correlative studies
15967766|NCT03128606|Drug|GLPG3067 single dose|GLPG3067 oral suspension, single ascending doses, daily
15967767|NCT03128606|Drug|Placebo single dose|Placebo, oral suspension, daily
15967768|NCT03128606|Drug|GLPG3067 multiple dose|GLPG3067 oral suspension, multiple ascending doses, daily for 14 days
15967769|NCT03128606|Drug|Placebo multiple dose|Placebo, oral suspension, daily for 14 days
15967770|NCT03128606|Drug|GLPG3067 oral suspension|GLPG3067 oral suspension, single dose, daily
15967771|NCT03128606|Drug|GLPG3067 oral tablet|GLPG3067 oral tablet, single dose, daily
15967772|NCT03128606|Drug|GLPG3067/GLPG2222 multiple dose|GLPG3067 oral suspension and GLPG2222 oral tablet, multiple doses, daily for 14 days
15967773|NCT03128606|Drug|GLPG3067/GLPG2222 Placebo multiple dose|GLPG3067 matching placebo oral suspension and GLPG2222 matching placebo oral tablet, multiple doses, daily for 14 days
15967774|NCT03128606|Drug|GLPG3067/GLPG2222/GLPG2737 multiple dose|GLPG3067 oral tablet, GLPG2222 oral tablet and GLPG2737 oral capsule, multiple doses, daily for 14 days
15967775|NCT03128606|Drug|GLPG3067/GLPG2222/GLPG2737 Placebo multiple dose|GLPG3067 matching placebo oral tablet, GLPG2222 matching placebo oral tablet and GLPG2737 matching placebo oral capsule, multiple doses, daily for 14 days
15967776|NCT03128593|Drug|JR-141|IV infusion (lyophilized powder), 0.01-2.0 mg/kg/week
15967777|NCT03128567|Device|Stimulation of the subthalamic nucleus|Stimulation of the subthalamic nucleus
15967778|NCT03128554|Other|Intervention with Training and Materials|Peer-Led Continuing Medical Education Session and Provider/Patient Handouts
15967783|NCT03128489|Biological|Infanrix-IPV/Hib|Subjects will receive (Infanrix-IPV/Hib) as three-dose primary vaccination course at 6, 10 and 14 weeks of age. The vaccine will be administered intramuscularly, at a 90-degree angle into the anterolateral side of the thigh on the right side. The vaccine should not be administered in the buttock.
15967784|NCT03128476|Dietary Supplement|Essence of Chicken|Brand's Essence of Chicken (BEC) is produced via a water extraction process from chicken meat for several hours under high-temperature, followed by centrifugation to remove fat and cholesterol, vacuum concentration to 3- to 4-fold, sterilization by high temperature and pressure before bottling. This kind of chicken essence is rich in protein, and low in sugar and fat, conveniently available and consumable, and easy for household storage.
15967785|NCT03128476|Dietary Supplement|Placebo (Energy matched)|
15967786|NCT03128463|Drug|Intravitreal injection of conbercept|We observe and collect patients with macular neovascular diseases who had intravitreal injections of conbercept. We do not interfere patients' treatment plan.
15967787|NCT03128450|Biological|human neural stem cell|human neural stem cell: 100ul/vessel，2 vessel/one bag，≥2×10 6cells/vessel
15967788|NCT03128437|Behavioral|Aerobic Exercise|At each of the six exposure sessions, participants will be invited to engage in 2-minute warm-up on the treadmill. Following this warm-up period, participants will be asked to briskly walk or jog on the treadmill at a speed that maintains their heart rate at 60-80% of maximum age-predicted heart rate for 20 minutes using the formula: (220-age) x (0.60 [lower bound] or 0.80 [upper bound]). Participants will be fitted with a heart rate monitor, which will be checked by a research assistant at 5-minute intervals in order to ensure adherence to this prescription; participants will be asked to adjust treadmill speed in order to remain in this range. Following each 20-minute exposure, participants will complete 5 minutes of cool down walking on the treadmill. Assessments will take place at baseline, week 2 (post-intervention), week 4, and week 8.
15967789|NCT03128424|Device|PQ Bypass Stent Graft System|The PQ Bypass™ Stent Graft System is indicated to improve luminal diameter in the treatment of patients with symptomatic de novo or restenotic native lesions or occlusions of the superficial femoral artery (SFA) and/or proximal popliteal artery, with reference vessel diameters of 5.0 to 6.7 mm and lesion lengths up to 180 mm.
15967790|NCT03128411|Drug|Bosutinib|All patinets will receive bosutinib at a starting dose of 400 mg QD.
15967791|NCT03128398|Drug|Domperidone|Availability of Domperidone to patients with serious gastrointestinal diseases or conditions when there is no comparable or satisfactory alternative therapy to diagnose, monitor, or treat the patient's disease or condition.
15967792|NCT03128385|Other|Intensive CIT Model Program|"Day Camp Model:
~The treatment was delivered in group-based design, 6 hours a day for 6 days (36 hours in total)
~constraint of the unaffected hand to encourage the use of the affected hand
~massed and repetitive practice of the affected hand during the period of constraint
~use of behavioral techniques termed shaping to train the affected hand"
15967793|NCT03128385|Other|Distributed CIT Model Program|"Home-Based Model:
~The participants will receive individualized interventions, 2.25 hours a day, two times a week for 8 weeks (36 hours in total).
~constraint of the unaffected hand to encourage the use of the affected hand
~massed and repetitive practice of the affected hand during the period of constraint
~use of behavioral techniques termed shaping to train the affected hand"
15967794|NCT03128372|Device|Desaturation|The delivered gas mixture will be adjusted to decrease the displayed saturation of peripheral oxygen. Each desaturation steps are of approximately 5 minutes duration with reduction in pulse oximeter oxygen saturation from 100 to 70%.
15967795|NCT03128359|Drug|Busulfan|Given IV
15967796|NCT03128359|Drug|Cyclophosphamide|Given IV
15967797|NCT03128359|Drug|Fludarabine Phosphate|Given IV
15967798|NCT03128359|Procedure|Hematopoietic Cell Transplantation|Undergo PBSC HCT
15967799|NCT03128359|Other|Laboratory Biomarker Analysis|Correlative studies
15967800|NCT03128359|Drug|Melphalan Hydrochloride|Given IV
15967801|NCT03128359|Drug|Mycophenolate Mofetil|Given IV or PO
15967802|NCT03128359|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo PBSC HCT
15967803|NCT03128359|Other|Quality-of-Life Assessment|Ancillary studies
15967804|NCT03128359|Drug|Tacrolimus|Given IV
15967805|NCT03128359|Radiation|Total-Body Irradiation|Undergo TBI
15967806|NCT03128346|Procedure|Transthoracic Transversus Plane Block|The investigator (RF or DV) will administer bilateral TTP block under dynamic ultrasound guidance with an echogenic needle using a total of 40mL of 0.5% ropivacaine (200mg), 20mL on each side. If the patient is less than 70kg, the total dose administered will be 40mL of 0.3% ropivacaine (150mg). The patient will not require sedation or analgesia for the performance of the block. The projected time for block completion is 20 minutes after appropriate patient positioning (supine) and exposure (upper chest). After block administration, the patient will be monitored for local anesthetics toxicity, hemodynamic instability, and allergic or unexpected adverse reactions for 20 minutes. Standard intensive care monitors are sufficient.
15967807|NCT03128346|Drug|Hydromorphone Hydrochloride|IV, Hydromorphone
15967808|NCT03128346|Drug|Aspirin|Oral Aspirin
15967809|NCT03128346|Drug|Acetaminophen|Oral acetaminophen
15967810|NCT03128346|Drug|Fentanyl|IV, fentanyl
15967811|NCT03128333|Other|RunKeeper app + physiotherapy coaching|RunKeeper app for half a year to self-monitor leisure-time PA.
15967812|NCT03128333|Other|Usual care|In the UMCG, patients who receive cancer treatment or in surveillance after treatment are normally advised to live healthy, stay active, and to maintain their weight.
15967813|NCT03128320|Drug|BAY1193397|Single dose of 1 mg BAY1193397 given in the fasted state
15967814|NCT03128320|Drug|BAY1193397|Single dose of 5 mg BAY1193397 given in the fasted state
15967815|NCT03128320|Drug|Placebo|Single dose of placebo given in the fasted state
15967816|NCT03128307|Device|Zyppah Anti-snoring Appliance|Use of an OTC mouth guard at night to prevent snoring
15967817|NCT03128294|Other|Retrospective, cross-sectional descriptive analysis|This study is a retrospective, cross-sectional descriptive analysis, and concerns the extraction of data from anonymised patient files. A database will be constructed and descriptive statistics will be used to summarise the data.
15967818|NCT03128281|Behavioral|Questionnaires|"Questionnaires completed 30 days before surgery, two (2) hours after surgery, when leaving the post-anesthesia care unit (PACU), and at hospital discharge.
~Questionnaires ask about pain level and any drugs taken for it. It should take about 5 minutes to complete."
15967819|NCT03128281|Device|Conventional Insufflation System (CIS)|CIS with pressure target of 15±1 mmHg used for pneumoperitoneum during laparoscopic/robotic surgery.
15967820|NCT03128281|Device|ConMed AirSeal Insufflation System (AIS) at Low Pressure|AIS with an insufflation pressure target of 9±1 mmHg used for pneumoperitoneum during laparoscopic/robotic surgery.
15967821|NCT03128281|Device|ConMed AirSeal Insufflation System (AIS) at Higher Pressure|AIS with an insufflation pressure target of 15±1 mmHg used for pneumoperitoneum during laparoscopic/robotic surgery.
15967822|NCT03128268|Device|Imaging software for 4 dimensional images for Cardiac MRI|All enrollees will receive Cardiac MRI scans using Imaging software for 4 dimensional images for Cardiac MRI
15967823|NCT03128255|Other|Assessment of already preacquired I-124 PET/US|Assessment of preacquired I-124 PET/US by review of anonymous digital case files
15967824|NCT03128242|Drug|Oxytocin|intranasal administration of oxytocin (24IU)
15967825|NCT03128242|Drug|placebo|intranasal administration of placebo (24IU)
15967826|NCT03128216|Procedure|Blind Local Anesthetic infiltration|Patients of this group received blind local anesthetic infiltration on surgical site. Local anesthetic infiltration are performed by surgeon.
15967827|NCT03128216|Procedure|Transversals Fascia Block|Patients of this group received ultrasound guided omolateral Transversals Fascia Block.
15967828|NCT03128216|Procedure|Spinal Anesthesia|Patients of this group received Spinal Anesthesia
15967829|NCT03128216|Drug|Ropivacaine|Local anesthetic used for local infiltration and Transversals fascia block
15967830|NCT03128216|Drug|Bupivacaine|Local anesthetic used for Spinal Anesthesia
15967831|NCT03128203|Drug|Oxytocin|Oxytocin, intranasally administrated
15967832|NCT03128203|Drug|Placebos|Saline, intranasally administrated
15967833|NCT03128190|Other|Pulse pressure variation monitoring|fluids boluses of colloids were given to maintain continuously measured PPV at 10% or less
15967834|NCT03128177|Dietary Supplement|Dietary sodium|High (6 g) versus low (1.5 g) sodium diet
15967835|NCT03128164|Drug|HMPL-689|Two strengths of HMPL-689 capsules (2.5 mg and 10 mg) will be used for clinical studies. The drug products are capsules.
15967836|NCT03128151|Behavioral|Educational program for clinicians: implementation of a package of clinical prevention measures of NMB|Intraoperative neuromuscular monitoring and pharmacological reversion of NMB according to data sheet
15967837|NCT03128138|Drug|SPH3127|"Drug: SPH3127 Tablet
~Drug: Placebo Tablet"
15967838|NCT03128125|Other|clinical examination in neurology|This examination is based on the movement of the child in a standing position (forward and backward on a straight line, jumping on a foot ...), seated (visual continuation ...) and elongated (tone, patellar and achillian reflexes, superficial sensitivity ...) . This makes it possible to evaluate all the neurological systems.
15967839|NCT03128125|Other|neuropsychological examination|This examination is based on the use of standardized psychometric tools and validated with children, usually used in clinical practice.
15967840|NCT03128125|Other|anamnestic elements|Several elements will be collected during the clinical interview to inform the history of the child's development, such as neonatal data (term of pregnancy, APGAR score ...), age of appearance of the first words , seating, walking, possible care, level of education ans level of education of the parents.
15967841|NCT03128112|Other|Exam room with poster|This intervention will assess whether a novel educational exam room poster can effectively prompt patients to ask pediatricians about their children's weight status and improve patents' perceptions of their children's weight status.
15967842|NCT03128099|Behavioral|Virtual reality social skills training|Participants play a virtual reality video game involving social interactions with various characters ( avatars) at a bus stop, a cafeteria and a grocery store. The games become progressively more complex as the participant improves task performance. Eye tracking patterns are recorded throughout the game to observe the patterns of social attention
15967843|NCT03128086|Procedure|Protocol-directed weaning|A protocol-directed weaning in neurological patients undergoing mechanical ventilation will reduce the rate of extubation failure and associated complications comparing with a conventional weaning (control group)
15967844|NCT03128073|Device|Carry life system, ultrafiltration (CLS UF)|The addition of Glucose-salt intermittently to a volume of the intraperitoneal fluid in the device which is then returned to the subject.
15967845|NCT03128060|Other|Home-based palliative care|The HBPC model consists of home visits by an interdisciplinary primary palliative care team (a physician, nurse, social worker, and chaplain). This team provides pain and symptom management, psychosocial support, advance care planning, spiritual counseling, grief counseling, and other services to meet patient and caregiver needs. Within the first week of a patient's enrollment, team members separately visit the patient at home to assess his/her needs as well as the needs of his/her caregiver. Following the patient's initial assessment, subsequent home visits are based on the patient's and caregiver's needs. At a minimum, a core team member visits the patient at home once per week. Additionally, a 24/7 helpline provides access to nurse counseling and after-hours home visits as needed. As a patient's health declines and he/she becomes eligible for hospice care, HBPC clinicians will refer the patient to hospice.
15967846|NCT03128060|Other|Enhanced usual care|"Usual primary care consists of: 1) appointment-based access to primary care providers (PCPs) as requested by the patient; 2) case management services; and 3) provider support through palliative care consultation. These PCPs provide family/internal medicine services as well as access to specialist care. They also offer disease case management and pain and symptom management.
~These usual care services are enhanced through training in palliative care provided to PCPs. The training addresses core elements of palliative care, specifically these 6 topics: a palliative care overview; strategies for improving patient-provider communications; instruction in ACP; instruction in managing patients' pain and symptoms; care coordination; and preventing medical crises."
15967847|NCT03128047|Device|Optune NovoTTF-200A System|Optune NovoTTF-200A System receive treatment with 200kHz for a minimum of 18 hours per day in 28 day cycles combined with Temozolomide and Bevacizumab.
15967848|NCT03128034|Drug|Cyclosporine|Given PO or IV
15967849|NCT03128034|Drug|Fludarabine Phosphate|Given IV
15967850|NCT03128034|Other|Laboratory Biomarker Analysis|Correlative studies
15967851|NCT03128034|Drug|Mycophenolate Mofetil|Given PO or IV
15967852|NCT03128034|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo allogeneic PBSC transplant
15967853|NCT03128034|Other|Pharmacological Study|Correlative studies
15967857|NCT03128021|Drug|Escitalopram Pill|Double-blinded, randomly assigned
15967858|NCT03128021|Other|Placebo|Double-blinded, randomly assigned
15967859|NCT03128021|Drug|Levomilnacipran Pill|Double-blinded, randomly assigned
15967860|NCT03128008|Drug|Carboplatin|Single arm non randomized open label study. Subjects will receive standard of care Carboplatin IV once a week. Chemotherapy is given concurrently with daily hyperfractioned radiation therapy.
15967861|NCT03128008|Drug|Paclitaxel|Single arm non randomized open label study. Subjects will receive standard of care Paclitaxel IV once a week. Chemotherapy is given concurrently with daily hyperfractioned radiation therapy.
15967862|NCT03128008|Radiation|Daily hyperfractionated radiation therapy|All subjects will receive 6 fractions(2Gy per fraction) of radiation therapy weekly. All subjects will complete an interim PET-CT after 48Gy-54Gy of RT . Subjects with a complete response on PET will complete RT at 60 Gy; subjects who have residual disease on interim PET and meet strict planning constraints eligibility will proceed to boost RT for a total RT dose of 72Gy. Interim PET-CT response will be measured using PERCIST criteria.
15967863|NCT03127995|Radiation|HYPOFRACTIONATED|40 Gy/ 15 fractions / 3 weeks
15967864|NCT03127995|Radiation|NORMOFRACTIONATED|50 Gy/ 25 fractions / 5 weeks
15967865|NCT03127982|Behavioral|Unified Protocol|The Unified Protocol (UP) is a trans-diagnostic cognitive-behavioral therapy (tCBT) for individuals diagnosed with anxiety disorders, depression and related disorders (which we refer to as emotional disorders).
15967866|NCT03127969|Other|Fluidotherapy treatment|fluidotherapy and joint protection and exercise
15967867|NCT03127969|Other|Joint protection and exercise|joint protection and exercise
15967868|NCT03127956|Drug|Olumacostat Glasaretil Gel, 5.0%|Gel containing Olumacostat Glasaretil
15967869|NCT03127943|Drug|Lidocaine|Efficacy for mandibular molar and canine anesthesia
15967870|NCT03127930|Behavioral|Intervention|Participants receive 5 individualized contacts (home visits and phone calls) with either a social worker or a nurse to develop problem solving skills as applied to medication management.
15967871|NCT03127917|Dietary Supplement|L-citrulline|L-citrulline capsules given at 6 g/day
15967872|NCT03127917|Other|Placebo|Maltodextrin capsules given as placebo
15967875|NCT03127891|Behavioral|pranayama yoga|providing short term pranayama yoga for 5 sessions before surgery patients under going cardiac surgery.
15967876|NCT03127891|Other|control group|no intervention should be given to patients allocated to this group
15967877|NCT03127878|Other|Exercise|
15967878|NCT03127852|Device|Medly|
15967879|NCT03127839|Procedure|Eccentric Strengthening|Use of eccentric strengthening exercises in treatment plan during visits and at home.
15967880|NCT03127839|Procedure|Traditional Strengthening|Use of traditional strengthening exercises in treatment plan during visits and at home.
15967881|NCT03127839|Behavioral|Pain education|Addition of pain neuroscience-focused education in addition to strengthening exercise program
15967882|NCT03127826|Procedure|Risk Stratified Care|"Physical therapists providing care will all have attended live training in PIPT principles and be involved in monthly continuing education on these principles. The use of specific principles is guided by the patient's risk stratification (as determined by the STarT Back Tool).
~Medium Risk:
~- Reassurance will be provided to address specific concerns related to their LBP and implications on work
~High Risk:
~- Physical therapy will be psychologically augmented with the assessment of biopsychosocial risk factors and the adoption of cognitive behavioral principles that explore patient concerns and address unhelpful beliefs and behaviors, including tailored education (e.g., stress management and pain neuroscience), graded exercise, & graded exposure"
15967883|NCT03127826|Procedure|Usual Care|Usual care at the general practitioner's discretion
15967884|NCT03127813|Other|Application of continuous positive airway pressure (CPAP)|CPAP will be delivered at 4 different pressure levels (6, 10, 13 and 16cmH2O) in a randomly allocated order
15967885|NCT03127800|Drug|Morphine sulphate|5mg of intravenous morphine sulphate diluted to 5ml with normal saline (0.9% sodium chloride) will be administered 30 minutes before participant's bed time. The same dose will be administered four hours later. In both instances 4 mg of intravenous ondansetron will be administered after the morphine sulphate dose to prevent sickness.
15967886|NCT03127787|Diagnostic Test|CMV Assay|Molecular diagnostic test to detect CMV
15967887|NCT03127774|Drug|Cisplatin|"Route of administration: Intraperitoneal for tumor treatment. Dose of 250 mg/m2
~Drug 1 of the hyperthermic intraperitoneal chemotherapy (HIPEC)"
15967888|NCT03127774|Drug|Sodium thiosulfate|"Route of administration: Intravenous Loading dose of 7.5 gm/m2 over 20 minutes followed by 2.13 gm/m2/hr for 12 hours
~Drug 2 given intravenously during hyperthermic intraperitoneal chemotherapy (HIPEC)"
15967889|NCT03127774|Procedure|Cytoreductive surgery|Standard of care: Surgical procedure used to remove tumors from patients with peritoneal tumors.
15967890|NCT03127761|Other|Allogeneic Hematopoietic Stem Cell Transplant|This observational study will compare outcomes of prospectively enrolled HCT recipients with outcomes of a cohort of matched autoHCT controls.
15967891|NCT03127735|Drug|BAY1436032|"BAY1436032 administered continuously as a single agent dosed twice a day orally on Days 1 to 28 of a 28-day cycle.
~Patients may continue treatment with BAY1436032 until disease progression, development of other unacceptable toxicity or Investigator discretion."
15967892|NCT03127722|Procedure|Blood draw|Decision for either treatment will be based upon clinical practice and physician/patient counseling. In addition of routine care practice, blood draws will be performed at baseline, 12 months and 60 months on subjects undergoing either an ESSURE procedure or a laparoscopic tubal sterilization.
15967893|NCT03127722|Device|ESSURE (BAY1454032)|Decision for either treatment will be based upon clinical practice and physician/patient counseling, and will not be specified in the study protocol.
15967999|NCT03127046|Drug|Aceclofenac and Esomeprazole|Oral single dose administration of aceclofenac 200mg and esomeprazole concomitant
15967894|NCT03127722|Procedure|Laparoscopic tubal sterilization|Decision for either treatment will be based upon clinical practice and physician/patient counseling, and will not be specified in the study protocol.
15967895|NCT03127709|Behavioral|Trail Making Test, Parts A & B|Part A is a timed measure of visual scanning and graphomotor speed. Part B is a timed measure of cognitive flexibility.
15967896|NCT03127709|Behavioral|Brief Test of Attention|Assesses auditory working memory
15967897|NCT03127709|Behavioral|Symbol Span|Assesses visual working memory
15967898|NCT03127709|Behavioral|Controlled Oral Word Association Test|The COWA timed test of phonemic verbal fluency. It requires the subject to generate as many words as possible, beginning with a given letter of the alphabet (i.e., F, A, and S).
15967899|NCT03127709|Behavioral|The Hopkins Verbal Learning Test-Revised|HVLT-R is a test of verbal learning and memory. Scores obtained are the total number of words.
15967900|NCT03127709|Behavioral|Brief Visuospatial Memory Test-Revised|The BVMT-R is a test of visuospatial learning and memory.
15967901|NCT03127709|Behavioral|Hospital Anxiety and Depression Scale|The HADS is a brief assessment validated in many cancer populations.
15967902|NCT03127709|Behavioral|McGill Quality of Life Scale|This is a questionnaire that is a validated 17-item QOL instrument validated for ill patients and in the particular context of the ancer.
15967903|NCT03127709|Diagnostic Test|MR Brain Imaging|Standard of care brain MR imaging includes high-resolution 3D T1-weighted images in the axial plane. The axial T1-weighted images will be isotropic with a typical matrix size of 256 x 256, 256 mm field-of-view (FOV) and 1 mm slice thickness covering the whole brain.
15967904|NCT03127709|Diagnostic Test|Resting state functional MRI|Scanning will be performed on a 3 Tesla General Electric scanner (Optima 750W) with a GEM HNU 24-channel head coil. rsFMRI matching the FLAIR and T1 post-contrast images will be obtained. For resting state fMRI, T2*-weighted images will be acquired with a single-shot gradient echo echo-planar imaging (EPI) sequence in the axial orientation (TR = 2500 ms, TE = 30 ms, FA = 80°, slice thickness = 4 mm, FOV= 240mm2, matrix=64×64) covering whole brain. For the resting state fMRI portion of the scan, patients will be instructed by the technologist or research staff to leave eyes open, focus on looking at a crosshair, and not think about anything during the scan.
15967905|NCT03127709|Behavioral|Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog)|This is a validated 37-item QOL instrument for cancer patients with cognitive complaints. The measures consist of FACT-Cog total, perceived cognitive impairments, perceived cognitive abilities, and impact on quality of life.
15967906|NCT03127696|Procedure|Fecal Microbiota Transplantation|FMT
15967907|NCT03127696|Behavioral|Lifestyle Modification Program|Lifestyle
15967908|NCT03127696|Procedure|Sham|Sham
15967909|NCT03127683|Other|Neutral position|The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position
15967910|NCT03127683|Other|Extension|The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position
15967911|NCT03127683|Other|Flexion|The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position
15967912|NCT03127683|Other|Rotation|The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed at this position
15967913|NCT03127683|Device|Ambu AuraGain TM|Single Use Laryngeal Mask Sterile
15967914|NCT03127670|Drug|Solanum melongena peel extract 0.05%|Administered topically twice daily for 12 weeks
15967915|NCT03127657|Drug|Cock's comb extract 0.01%|Applied topically twice daily for 12 weeks
15967916|NCT03127644|Drug|Sodium Zirconium Cyclosilicate (ZS) 5g|Suspension administered 5g orally three times daily for 48 hours.
15967917|NCT03127644|Drug|Sodium Zirconium Cyclosilicate (ZS) 10g|Suspension administered 10g orally three times daily for 48 hours.
15967918|NCT03127644|Drug|Placebo|Placebo suspension administered orally placebo three times daily for 48 hours.
15967919|NCT03127631|Behavioral|Nutrition|Standardized advice on healthy diet practices.
15967920|NCT03127631|Behavioral|Exercise|Standardized advice on exercise including strength training and resistance training exercises.
15967921|NCT03127631|Behavioral|Smoking cessation|Advice to quit smoking, if applicable, and on available aids to quit smoking,
15967922|NCT03127631|Drug|Antiplatelet agent, such as Aspirin, or other low-dose antiplatelet agent|Prescription for a low-dose antiplatelet agent, such as aspirin 81-100mg daily or if intolerant of aspirin, other low-dose antiplatelet agent
15967923|NCT03127631|Drug|Statin, such as Simvastatin, Atorvastatin, Rosuvastatin, Pravastatin)|Prescription for a low to moderate dose statin, such as simvastatin 10-40mg daily, atorvastatin 10-40mg daily, rosuvastatin 5-20mg daily or pravastatin 10-40mg daily.
15967924|NCT03127631|Drug|ACE inhibitor|Prescription for an ACE-I (preferable) or an angiotensin receptor blocker for baseline systolic blood pressure greater >120mmHg, or other blood pressure lowering medication as applicable.
15967925|NCT03127618|Drug|Lorlatinib|
15967926|NCT03127605|Drug|Inotuzumab Ozogamicin|
15967927|NCT03127592|Drug|Fixed Dose Combination|Fixed Dose Combination of Etodolac 400 mg + Cyclobenzaprine 10 mg
15967928|NCT03127592|Drug|Etodolac|Individual drug
15967929|NCT03127592|Drug|Cyclobenzaprine|Individual drug
15967930|NCT03127579|Behavioral|Longer meal duration|Participants have 50% more time to eat than usual
15967931|NCT03127553|Dietary Supplement|Low-sodium diet with standard bread|low-sodium diet (2300 mg Na/die) with use of standard bread (750 mg Na/100g) for 6 months
15967932|NCT03127553|Dietary Supplement|Low-sodium diet with low-sodium bread|low-sodium diet (2300 mg Na/die) with use of low-salt bread (280 mg Na/100g) for 6 months
15967933|NCT03127514|Drug|AMX0035|AMX0035
15967934|NCT03127514|Other|Placebo|Matching Placebo Comparator
15967935|NCT03127475|Device|Transcranial direct current stimulation|A consecutive 5-days course of tDCS will be delivered. In treatment group, true stimulation will be administrated and sham stimulation will be delivered in control group.
15968053|NCT03126786|Drug|SC CLS-TA|CLS-TA [4 mg/100 μL] SC injection
15968054|NCT03126773|Drug|BAY86-4891|Drospirenone 0.25 mg + estradiol hemihydrate 0.5 mg (Angeliq Micro, G03FA17).Dosage form is one tablet a day.
15968055|NCT03126760|Drug|Acthar Gel|Acthar Gel 1 mL (80U) for subcutaneous injection
15967936|NCT03127462|Behavioral|Nurse-led educational intervention|Patients in the intervention group will receive an individual face-to-face conversation with a duration of 45 min. All patients will have access to telephone counselling by their primary nurse when needed and able to arrange a new face-to-face conversation. After 4-6 weeks the face-to-face the nurse will of conversation reach out to the patient by phone to follow up on the earlier conversation. Three months after the face-to-face conversation the nurse will offer the patient a closing face-to-face conversation of 15 min at the same time where the patient has a doctor appointment at the department. Those who are in the control group will continue standard care and not receive any conversation and be used as the control group.
15967937|NCT03127449|Drug|Alflutinib|patients take Alflutinib orally once per day at different dose
15967938|NCT03127436|Drug|Acarovac|House dust mite sensitized Patients receive increasing doses of subcutaneous immunotherapy with Acarovac. During the up-dosing phase, patients will receive 4 injections in 1-2 week intervals with increasing allergen amount up to the individual maximum tolerable dose. After reaching the individual maximum tolerable dose patients will receive one maintenance dose in a 4 - 8 week interval.
15967939|NCT03127423|Procedure|Hybrid ablation|This intervention includes totally thoracoscopic surgical ablation and percutaneous catheter ablation simultaneously.
15967940|NCT03127423|Procedure|Thoracoscopic surgical ablation|This intervention only includes totally thoracoscopic surgical ablation without percutaneous catheter ablation.
15967941|NCT03127410|Other|Lumbar traction|Lumbar traction is used to decompress the spinal structures and relieve pressure and may stretch the spine.
15967942|NCT03127397|Behavioral|Praise message phone call|Praise message phone calls after each completed ART appointment, up to two calls per month.
15967943|NCT03127384|Device|Restylane Lidocaine|Hyaluronic acid based filler
15967944|NCT03127384|Other|No-treatment control|No-treatment control
15967945|NCT03127371|Drug|Nitrous Oxide|Patients undergoing incision and drainage of abscess will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device while undergoing standard incision and drainage of cutaneous abscess . The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing.
15967946|NCT03127371|Drug|Oxygen|Patients undergoing incision and drainage of abscess will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive 100% oxygen gas via the Nitrous Oxide gas mixer device while undergoing standard incision and drainage of cutaneous abscess . The device will deliver only oxygen at a fixed concentration of 100%. The on demand valve requires patient inspiration to trigger dosing.
15967947|NCT03127358|Device|AiCure|Smartphone App
15967948|NCT03127358|Device|AiCure with gamification|Smartphone App with gaming.
15967949|NCT03127345|Drug|Omegaven|Intravenous omega 3 fatty acid administration
15967950|NCT03127345|Drug|Intralipid|Standard of care
15967951|NCT03127332|Other|Carevive CPS|This intervention will focus on the use of the Carevive CPS at the point of treatment decision making, enabling providers to deliver evidence-based and personalized treatment care plans to their metastatic breast cancer patients on active treatment. The Carevive CPS collects electronic patient reported outcomes (ePROs) and clinical data, reported and generated by clinical staff and/or peer-reviewed evidence, and includes patient education, resources, and referrals developed by cancer clinicians and researchers.
15967952|NCT03127319|Drug|apatinib docetaxel zoledronic|apatinib 500 mg qd p.o.docetaxel 60mg/m² iv q3w;zoledronic 4mg iv>15min q4w until disease progression or intolerable toxicity or patients withdrawal of consent
15967953|NCT03127319|Drug|docetaxel zoledronic|docetaxel 60mg/m² iv q3w;zoledronic 4mg iv>15min q4w until disease progression or intolerable toxicity or patients withdrawal of consent
15967954|NCT03127306|Diagnostic Test|Assessment of Polish version of BPS|Validation of Polish Version of BPS.
15967955|NCT03127293|Diagnostic Test|DEXA|Blood samples (10 mL) were drawn at the time of DEXA scans in postpartum period
15967956|NCT03127280|Other|Fast Track foley removal|Foley catheter is removed at 4 hours after surgery
15967957|NCT03127267|Drug|Masitinib (6.0)|Masitinib (titration to 6.0 mg/kg/day)
15967958|NCT03127267|Drug|Riluzole|Riluzole 50 mg tablet, treatment per os
15967959|NCT03127267|Drug|Placebo|treatment per os
15967960|NCT03127267|Drug|Masitinib (4.5)|Masitinib (titration to 4.5 mg/kg/day)
15967961|NCT03127254|Behavioral|Video narrative|create a 10-15 minute video intervention about teen experiences after being diagnosed with cancer
15967962|NCT03127254|Behavioral|PedsQL|A generic 23-item Health Related Quality of Life measure initially developed using pediatric cancer patients
15967963|NCT03127254|Behavioral|Ten Item Personality Inventory|The TIPI consists of ten items and measures personality based the subject's agreement of descriptions of themselves taken from the Big-5 model of personality
15967964|NCT03127254|Behavioral|Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency Test|The D-KEFS Verbal Fluency Test consists of three subtests, which take approximately 6 minutes to complete
15967965|NCT03127254|Behavioral|The Cognitive Log|The Cog-Log is a 5-10 minute assessment designed to measure basic cognitive functioning and orientation
15967966|NCT03127241|Device|Assistive device (Armon Ayura) test|"Short Training (T0-T1) - each subject will undergo a 3-day training at the clinical center during which technicians, along with a physiotherapist will adjust and customize the device and explain possible independent use at home.
~Domestic use (T1-T2) - Subjects will use the device during their daily life activities for two weeks at home. They will perform task-oriented movements (e.g. reaching a mouse and objects on a table, moving back to the wheelchair, drinking), free movements, playful activities (e.g. playing chess, leafing through a book), and self-care activities, accordingly to subject's residual capability, for a minimum period of 5 hours/day. They will keep a structured diary where all the problems, achievements and comments will be reported."
15968056|NCT03126760|Drug|Placebo|Placebo for subcutaneous injection
15968057|NCT03126747|Drug|BAY86-5300_YAZ-Flex|Patients with endometriosis-associated pelvic pain and/or dysmenorrhea are enrolled solely after the physician's decision of YazFlex treatment in routine clinical practice.
15968091|NCT03126487|Procedure|HIGH INTENSITY FOCUSED ULTRASOUND|HIGH INTENSITY FOCUSED ULTRASOUND GUIDED BY MRI AS THERMIC DESTRUCTION
15967967|NCT03127241|Device|Assistive device (Jaeco Wrex) test|"Short Training (T0-T1) - each subject will undergo a 3-day training at the clinical center during which technicians, along with a physiotherapist will adjust and customize the device and explain possible independent use at home.
~Domestic use (T1-T2) - Subjects will use the device during their daily life activities for two weeks at home. They will perform task-oriented movements (e.g. reaching a mouse and objects on a table, moving back to the wheelchair, drinking), free movements, playful activities (e.g. playing chess, leafing through a book), and self-care activities, accordingly to subject's residual capability, for a minimum period of 5 hours/day. They will keep a structured diary where all the problems, achievements and comments will be reported."
15967968|NCT03127228|Other|Standard mechanical debridement|Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with dental scalers prior to bone grafting regenerative therapy
15967969|NCT03127228|Device|Er:YAG laser-assisted debridement|Implantoplasty will be performed for peri-implant suprabony defect and infrabony defect will be debrided with the aid of the laser prior to bone grafting regenerative therapy
15967970|NCT03127215|Drug|Olaparib|Olaparib 150 mg tablet
15967971|NCT03127215|Drug|Physician's choice|treatment according to current guidelines
15967972|NCT03127215|Drug|Trabectedin|Trabectedin 1.1mg/m² infusional solution
15967973|NCT03127202|Device|Cardiac Resynchronization Therapy -Defibrillator (range PARADYM, LivaNova, Clamart, France)|Patients were implanted with a Cardiac Resynchronization Therapy -Defibrillator (model PARADYM RF SONR CRT-D 9770 or PARADYM RF CRT-D 9750, Sorin) having 3 left ventricular polarities. The choice of the right atrial, right ventricular and bipolar left ventricular leads was left to investigators' discretion.
15967974|NCT03127189|Drug|Rilpivirine|Rilpivirine 25 mg immediate release oral solution.
15967975|NCT03127189|Drug|Rilpivirine Long-acting Parenteral Formulation|RPV LA 600 mg extended-release suspension for IM injection.
15967976|NCT03127176|Other|Genome sequencing of fecal samples|Fecal samples will be collected and then frozen in the morning pre-prandial after having fasted overnight. DNA will be separated and stored at -80°C in our center (Biobanc) until assayed. Sequencing will be performed with the most appropriate platform.
15967977|NCT03127163|Device|Intraestromal corneal ring|The patients underwent surgery to implant the intrastromal corneal ring (Ferrara Ophthalmics, Belo Horizonte, Brazil) using a manual technique. The procedures were performed by a single surgeon with extensive training in corneal surgery. All patients received the same ring, and the number (1 or 2 segments), thickness, and arc size were calculated using the nomogram provided by the manufacturer.
15967978|NCT03127137|Other|Control cohort group|Control cohort group will receive medications not predetermined by the set protocol.
15967979|NCT03127137|Drug|Experimental Group 1 triamcinolone and lidocaine|Experimental Group 1 will receive Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL 1% lidocaine (total volume 4 cc)
15967980|NCT03127137|Drug|Experimental Group 2 triamcinolone and saline|Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL preservative saline (total volume 4 cc)
15967981|NCT03127124|Drug|NANT-008|Paclitaxel: benzenepropanoic acid, β-(benzoylamino)-α-hydroxy-(2aR, 4S, 4aS, 6R, 9S, 11S, 12S, 12aR, 12bS)-6,12b-bis(acetyloxy)-12-(benzoyloxy)-2a, 3, 4, 4a, 5, 6, 9, 10, 11, 12, 12a, 12b-dodecahydro-4,11-dihydroxy-4a, 8, 13, 13-tetramethyl-5-oxo-7,11-methano-1H-cyclodeca[3,4]benz[1,2-b]oxet-9-y1ester,(αR,βS)-(9CI)
15967982|NCT03127124|Drug|Fluorouracil Injectable Product|5-fluoro-2,4 (1H,3H)-pyrimidinedione.
15967983|NCT03127124|Drug|Avastin Injectable Product|Recombinant humanized monoclonal IgG1 antibody
15967984|NCT03127124|Drug|Leucovorin Calcium Injection|Calcium N -[p -[[[(6RS )-2-amino-5-formyl-5,6,7,8-tetrahydro-4-hydroxy-6-pteridinyl]methyl]amino]benzoyl]-L-glutamate (1:1).
15967985|NCT03127124|Drug|Eloxatin Injectable Product|cis-[(1 R,2 R)-1,2-cyclohexanediamine-N,N'] [oxalato(2-)- O,O'] platinum.
15967986|NCT03127111|Genetic|Gene mutations analysis|Genomic DNA extracted from paired fresh-frozen tumor and normal tissues is used for KRAS mutations, BRAF mutations, PIK3A mutations, and EGFR mutations, etc., by sequencing and for MSI analysis by PCR and capillary electrophoresis.
15967987|NCT03127111|Genetic|Gene methylation analysis|Genomic DNA extracted from paired fresh-frozen tumor and normal tissues is used for specific gene methylation or CIMP status analysis by MethyLight or bisulfite sequencing. Whole-genome bisulfite sequencing will be used to identify novel candidate set of predictive markers.
15967988|NCT03127111|Genetic|Gene expression analysis|RNA extracted from paired fresh-frozen tumor and normal tissues or serum is used for specific gene expression analysis by real-time reverse-transcription PCR (RT-qPCR). RNA-seq will be used to identify novel candidate set of predictive markers.
15967989|NCT03127111|Genetic|SNP analysis|Genomic DNA extracted from serum is used for specific SNP analysis by using sequencing. GWAS with SNPs array will be used to identify novel candidate set of predictive markers.
15967990|NCT03127111|Genetic|Protein expression analysis|Tissue microarray made from formalin-fixed paraffin-embedded (FFPE) paired tumor and normal tissues is used for specific protein expression analysis by immunohistochemistry staining.
15967991|NCT03127098|Biological|ETBX-011|ETBX-011 immunization will be administered by subcutaneous (SC) injection.
15967992|NCT03127098|Biological|ALT-803|ALT-803 will be administered by SC injection.
15967993|NCT03127072|Device|Radiofrequency Ablation (RFA)|The radiofrequency generator has the capacity to deliver 200 watts of alternating current to the needle electrode for the coagulation necrosis of soft tissue
15967994|NCT03127072|Drug|chemotherapy ± target therapy|chemotherapy ± target therapy
15967995|NCT03127059|Other|Breathing Exercises|"Key points in the intervention are
~Reduction (or normalising) of the respiration rate; use of rhythmic, nasal inspiration, diaphragmatic breathing; reduction of depth of breath, longer expiration; breath-holding at functional residual capacity.
~Relaxation, especially the neck, jaw, tongue, and shoulders. Emphasizing the impact of gravity to the body.
~Inclusion of the breathing modification into walking and other physical activities.
~Daily home exercise of BrEX."
15967996|NCT03127059|Other|Usual care|Participants will receive only short information given initially at recruitment. No instruction or booklet will be distributed in the Usual care-Group.
15967997|NCT03127046|Drug|Aceclofenac|Oral single dose administration of aceclofenac 200mg
15967998|NCT03127046|Drug|Esomeprazole|Oral single dose administration of aceclofenac 200mg
15968265|NCT03125265|Other|dietary intake of omega-3 and omega-6 polyunsaturated fatty acids|
15968000|NCT03127033|Other|Soft liner telescopes|"Soft liner telescopes: Overdenture will be adjusted by relieving acrylic opposite to the abutment about 2 mm using a metal stone. The relieved areas will be painted with an adhesive and the rest of the fitting surface of the denture will be painted with a separating medium.
~The soft liner (Silicone based soft liner, mollosil, chairside soft relining-long term, DETAX, Germany) will then be applied in the relieved areas to act as a secondary coping The base and catalyst will be mixed according to the manufacturer's instructions on a glass slab. The mix will be placed on the relieved area, seated in the patient's mouth, the patient is asked to bite in centric relation and the excess liner is removed with a lancet."
15968001|NCT03127020|Drug|PQR309|taken continuously on daily basis (60mg, 80mg) or intermittent dosing (120mg, 140mg, 160mg)
15968002|NCT03127007|Drug|Atezolizumab|Atezolizumab is given on day 1 of week 3, 6, 9 and 12 at 1200 mg IV.
15968003|NCT03127007|Drug|5-FU based radio-chemotherapy|IV protracted 5-FU given at 225mg/m2 over 24h 5 days/week for 5 weeks associated to radiotherapy.
15968004|NCT03126994|Device|PhysioWave Cardiovascular Analyzer|Measurement of Pulse Wave Velocity, Pulse Rate, Body Weight and BMI
15968005|NCT03126994|Device|AtCor XCEL PWA & PWV|Measurement of Pulse Wave Velocity and Pulse Rate
15968006|NCT03126994|Device|Detecto SOLO|Measurement of Body Weight and BMI
15968007|NCT03126981|Other|1.5 oz of whole, natural almonds|1.5 oz of whole, natural almonds
15968008|NCT03126981|Other|Low-fat, high refined starches/sugars|Low-fat foods, high in refined starches and added sugars
15968009|NCT03126968|Drug|Topical epinephrine|Prophylactic topical epinephrine
15968010|NCT03126968|Drug|Placebos|Topical placebo (normal saline)
15968011|NCT03126955|Diagnostic Test|Pre-Operative CISS-MRI Sequences|Compare pre-operative MRI diagnosis to intra-operative findings on if both are in agreement
15968012|NCT03126955|Diagnostic Test|Pre-Operative Interictal Laryngoscopy|Compare pre-operative laryngoscopy diagnosis to intra-operative findings on if both are in agreement
15968013|NCT03126955|Diagnostic Test|Pre-Operative Unilateral and Contralateral Botox|Compare pre-operative diagnosis using Botox to intra-operative findings on if both are in agreement
15968014|NCT03126942|Device|Novaloc|Attachment composed by a polyetheretherketone (PEEK) capsule and carbon-coated abutment. The yellow (medium) retentive component will be used
15968015|NCT03126942|Device|Locator|Traditional cylindrical attachment (Locator system) with pink (medium) retentive components
15968016|NCT03126929|Diagnostic Test|Coma Recovery Scale-Revised and Glasgow Coma Scale|Patients have been assessed with both the Coma Recovery Scale-Revised(CRS-R) and the Glasgow Coma Scale(GCS)
15968017|NCT03126916|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo autologous HSCT
15968018|NCT03126916|Drug|Busulfan|Given IV
15968019|NCT03126916|Drug|Carboplatin|Given IV
15968020|NCT03126916|Drug|Cisplatin|Given IV
15968021|NCT03126916|Drug|Crizotinib|Given PO
15968022|NCT03126916|Drug|Cyclophosphamide|Given IV
15968023|NCT03126916|Drug|Dexrazoxane Hydrochloride|Given IV
15968024|NCT03126916|Biological|Dinutuximab|Given IV
15968025|NCT03126916|Drug|Doxorubicin Hydrochloride|Given IV
15968026|NCT03126916|Drug|Etoposide Phosphate|Given IV
15968027|NCT03126916|Radiation|External Beam Radiation Therapy|Undergo EBRT
15968028|NCT03126916|Radiation|Iobenguane I-131|Given IV
15968029|NCT03126916|Drug|Isotretinoin|Given PO
15968030|NCT03126916|Drug|Melphalan Hydrochloride|Given IV
15968031|NCT03126916|Biological|Sargramostim|Given SC
15968032|NCT03126916|Procedure|Therapeutic Conventional Surgery|Undergo standard of care surgery
15968033|NCT03126916|Drug|Thiotepa|Given IV
15968034|NCT03126916|Drug|Topotecan Hydrochloride|Given IV
15968035|NCT03126916|Drug|Vincristine Sulfate|Given IV
15968036|NCT03126903|Device|KeraKlear Non-Penetrating Keratoprosthesis|The KeraKlear is a flexible non-penetrating artificial cornea designed to be implanted through small corneal incisions in subjects with corneal opacity.
15968037|NCT03126877|Drug|Mitomycin C|The surgical procedure includes a low dose, short duration mitomycin C (MMC) treatment on the exposed stromal bed of the non-dominant eye, before the unilateral implantation of the corneal inlay. This treatment is at a concentration of 0.2 mg/mL (0.02%) applied for 10 to 30 seconds on the stromal bed as well as the stromal side of the corneal flap or pocket.
15968038|NCT03126877|Device|Raindrop Near Vision Inlay|The surgical procedure includes the unilateral implantation of the Raindrop Near Vision Inlay in the non-dominante eye for the improvement of uncorrected near vision.
15968039|NCT03126864|Procedure|Leukapheresis|After enrollment, steady state leukapheresis performed to collect apheresis material. The goal is to achieve a target total nucleated cell (TNC) yield of at least 5 x 10^9 (expected range 5 x 10^8 - 5 x 10^10), for up to two days.
15968040|NCT03126864|Drug|Fludarabine|25 mg/m2 administered by vein on Days -5 to -3.
15968041|NCT03126864|Drug|Cyclophosphamide|900 mg/m2 administered by vein on Day -3.
15968042|NCT03126864|Biological|CD33-CAR-T Cell Infusion|CD33-CAR-T cell infusion administered by vein on Day 0. First group of participants receive the lowest dose level. Each new group will receive a higher dose than the one before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of T-cells is found. Starting dose level is > 1.5 x 105/kg but ≤ 4.5 x 105/kg.
15968044|NCT03126825|Device|CP910/CP920 with noise reduction on|This intervention uses the approved Nucleus 6 system (CP910/CP920 and accessories) but adds the investigational noise reduction algorithm.
15968045|NCT03126825|Device|CP910/CP920|The approved CP910 or CP920 Sound Processor.
15968046|NCT03126812|Drug|Carboplatin|Carboplatin AUC=6
15968047|NCT03126812|Drug|Paclitaxel|paclitaxel 80 mg/m2
15968048|NCT03126812|Drug|Pembrolizumab|200 mg flat dose, starting cycle 2
15968049|NCT03126799|Drug|Erlotinib plus Bevacizumab|Erlotinib 150mg, po, daily, q 3weeks plus Bevacizumab 15mg/kg, IV, on D1 Q 3 weeks
15968050|NCT03126799|Drug|Erlotinib|Erlotinib 150mg, po, daily, Q weeks
15968051|NCT03126786|Drug|IVT aflibercept|IVT aflibercept [2 mg/0.05 mL]
15968052|NCT03126786|Drug|Sham SC|sham SC
15968058|NCT03126734|Other|Infant Massage course|"Infant massage courses consist of 5 sessions. Investigators explain parents how to make an infant massage technique to their babies and which should be the general conditions of the environment.
~This massage is based on the methodology of the International Association of infant massage (IAIM) created by Vimala Schnneider. The courses will make individually."
15968059|NCT03126721|Drug|midazolam|a single oral dose of 2 mg midazolam
15968060|NCT03126721|Drug|PF-06751979|multiple oral doses of PF-06751979 100 mg a day
15968061|NCT03126708|Drug|cetuximab|cetuximab (EGFR monoclonal antibody) plus standard chemotherapy
15968062|NCT03126708|Drug|cisplatin plus paclitaxel|Chemotherapy
15968063|NCT03126695|Drug|Ticagrelor granule|A P2Y12 receptor inhibitor provided as granule for suspension.
15968064|NCT03126695|Drug|Ticagrelor pediatric tablets|A P2Y12 receptor inhibitor provided as pediatric tablets to be swallowed whole.
15968065|NCT03126695|Drug|Ticagrelor pediatric tablets suspended in water|A P2Y12 receptor inhibitor provided as pediatric tablets suspended in water.
15968066|NCT03126695|Drug|Ticagrelor immediate release (IR) tablets (Commercial tablet)|A P2Y12 platelet inhibitor indicated to reduce the rate of thrombotic cardiovascular events in patients with acute coronary syndrome (unstable angina, non-ST (S and T waves) elevation MI or ST elevation MI) and in patients with a history of MI
15968067|NCT03126682|Drug|Wellbutrin SR 300Mg Extended-Release Tablet|Wellbutrin SR 300Mg Extended-Release Tablet
15968068|NCT03126669|Device|Hyperbaric oxygen|Breathing 100% oxygen at 2ATA in the hyperbaric chamber
15968069|NCT03126669|Device|Hyperbaric chamber, normal air|Hyperbaric chamber with normal air
15968070|NCT03126656|Drug|Testosterone Undecanoate|just hypogonadic patients enrolled received hormone replacement therapy with testosterone undecanoate 1000 mg/4ml intramuscular (IM) at baseline, after 6 weeks and 12 weeks after the first evaluation
15968071|NCT03126643|Biological|Nivolumab|"Opdivo (nivolumab) is a programmed death receptor-1 (PD-1) blocking antibody approved by the US Food and Drug Administration (FDA) on an accelerated basis for some types of cancer. Please contact your physician for more details."
15968076|NCT03126617|Biological|Elotuzumab|Elotuzumab (Emplicitii) is a Signaling Lymphocytic Activation Molecule Family member 7 (SLAMF7) directed immunostimulatory antibody approved by the US Food and Drug Administration (FDA) and indicated in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received one to three prior therapies. Please contact your physician for more details.
15968077|NCT03126604|Diagnostic Test|female sexual function index|evaluation of sexual functions questionnaire about Desire, Arousal, Orgasm,pain , lubrications, satisfactions
15968078|NCT03126591|Drug|Olaratumab|Administered IV
15968079|NCT03126591|Drug|Pembrolizumab|Administered IV
15968080|NCT03126578|Drug|LEO 32731|LEO 32731 is being developed by LEO Pharma.
15968081|NCT03126578|Drug|Midazolam|Benzodiazepine
15968082|NCT03126565|Other|Lifeline CareSage Flagging|Patients in the intervention group will receive active monitoring by the CareSage risk assessment platform and clinical interface, including nurse triage calls and tailored PHH interventions. Beginning at month 4, the CareSage algorithm will assess patients' risk for emergency transport every 30 days. Patients identified as high risk will receive nurse triage calls and, depending on their needs, tailored care according to a stepped-care approach. The principal goals will be to reinforce the patients' education, ensure compliance with medications and diet, and identify recurrent symptoms amenable to treatment on an outpatient basis to avoid readmissions
15968083|NCT03126552|Biological|Necator americanus L3 larvae|50 Necator americanus L3 larvae
15968084|NCT03126539|Drug|Sulforaphane|Isothiocyanate sulforaphane (SF), derived from broccoli sprouts, has been known to induce an antioxidant response through the Keap1-Nrf2-antioxidant response element pathway.
15968085|NCT03126539|Radiation|Narrow-band Ultraviolet B exposure|The investigators will use a Lumera ultraviolet B (UVB) light phototherapy device which allows for targeted delivery of controlled doses of UVB radiation (emission spectrum 290-320 nm).
15968086|NCT03126539|Procedure|4 mm skin punch biopsy|All areas will be biopsied using standard punch biopsy tools and following standard clinical protocols, including cleansing the skin with an alcohol wipe and injecting local anesthesia with lidocaine and epinephrine. No more than four total skin biopsies will be obtained from a volunteer over the course of the study. After removal of the tissue sample, one or two sutures are placed to close the circular opening. Sutures are removed and a scar is formed, but typically heals well without complications and blends well with the surrounding skin.
15968087|NCT03126526|Behavioral|Food specific Inhibitory control training|It involves a go/no-go task in which participants are requested to respond by clicking a particular button when a specific stimulus appears and requested to withhold their response when another particular stimulus appears. Stimuli in this intervention include photos of food and non-food.
15968088|NCT03126526|Behavioral|Implementation intentions|"It involves designing if-then strategies of behaviour. Participants will be asked to describe situations in which they feel they are more prone to behave in a way that is not congruent to their long term goals, and then to plan strategies to behave differently when faced with this situation in the future."
15968089|NCT03126526|Behavioral|General inhibitory control training|It involves a go/no-go task in which participants are requested to respond by clicking a particular button when a specific stimulus appears and requested to withhold their response when another particular stimulus appears. Stimuli in this intervention include only non-food pictures.
15968090|NCT03126513|Procedure|G-POEM|After confirmation of refractory gastroparesis, participants will undergo to gastric POEM. Participants will be admitted to hospital 24hrs before procedure and IV antibiotics will be given and then the procedure will be done. Technique consist of 4 steps: First: a submucosa injection of saline solution with methylene blue at 3-4cms from pylorus. Second: a submucosa incision and tunnel creation up to pyloric area. Third: Myotomy of the circular and longitudinal muscular layers of the pylorus and the antrum. Fourth: closure of the mucosal incision with hemoclips. After procedure they will be kept on surveillance and will be followed-up with clinical, endoscopic and scintigraphic studies up to 1 year after procedure.
15968092|NCT03126461|Radiation|SAbR|"For patients treated on the GRID A regimen, a dose of 15-20 Gy will be delivered with the GRID device in either a single field, with prescription to dmax, or with parallel opposed GRID fields (matching beamlets from the opposed directions). For patients treated on the GRID B regimen, this same dose will be delivered, with a subsequent regimen of 3 Gy X 10 fractions, with the first of these fractions following the GRID dose."
15968093|NCT03126461|Drug|Ipilimumab|ipilimumab 3mg/kg IV q3wk x 4
15968094|NCT03126461|Drug|Nivolumab|nivolumab 1 mg/kg IV q3wk x 4
15968095|NCT03126448|Diagnostic Test|Highly Sensitive Assays|Tissue will be collected at the time of surgery from patients in each arm of the study. In addition to tissue stored in RNAlater and sent to a research laboratory, cultures will also be sent to Quest Diagnostics for independent culture results.
15968096|NCT03126435|Drug|EndoTAG-1|twice weekly
15968097|NCT03126435|Drug|Gemcitabine|once weekly
15968098|NCT03126422|Drug|Dexmedetomidine|Pretreatment of different doses of dexmedetomidine
15968099|NCT03126409|Procedure|No-Touch vein harvesting technique|The No-Touch technique focuses on saphenous vein graft harvesting, featured by preserving the surrounding tissue of the vein while at the same time avoiding manual distension.
15968100|NCT03126409|Procedure|Conventional vein harvesting|During saphenous vein harvesting, surrounding tissue of the vein is stripped off, and manual distension is routinely performed
15968101|NCT03126396|Device|Urgo 310 3166 dressing|Experimental: Urgo 310 3166 dressing
15968102|NCT03126370|Drug|TDF with a boosted protease inhibitor|"Participants who are already taking tenofovir disoproxil fumarate 300 mg (in the form of Viread or Truvada) in combination with either a ritonavir- or cobicistat-boosted protease inhibitor for HIV treatment will continue to take their prescribed treatment for 12 weeks after enrollment.
~Other: Blood draws for tenofovir PK, renal function assessment"
15968103|NCT03126370|Drug|TAF with a boosted protease inhibitor|"Participants will be switched from tenofovir disoproxil fumarate to tenofovir alafenamide 25 mg/emtricitabine 200 mg with a boosted protease inhibitor.
~Other: Blood draws for tenofovir PK, renal function assessment"
15968104|NCT03126370|Drug|TAF with a boosted protease inhibitor and LDV/SOF|"After taking tenofovir alafenamide/emtricitabine for 12 weeks, participants will then start taking ledipasvir 90 mg/sofosbuvir 400 mg (Harvoni) in combination with the tenofovir alafenamide 25 mg/emtricitabine 200 mg (Descovy) and a boosted protease inhibitor for 4 weeks. Subjects will then return to taking tenofovir alafenamide 25 mg/emtricitabine 200 mg (Descovy) and a boosted protease inhibitor for the final 12 weeks.
~Other: Blood draws for tenofovir PK, renal function assessment"
15968105|NCT03126357|Other|Product A|Usual Brand Cigarette
15968106|NCT03126357|Other|Product B|FT21039 an electronic tobacco vapor product
15968107|NCT03126357|Other|Product C|FT21092 an electronic tobacco vapor product
15968108|NCT03126357|Other|Product D|FT21018 an electronic tobacco vapor product
15968109|NCT03126357|Other|Product E|4mg nicotine gum
15968110|NCT03126344|Device|King Vision video laryngoscope|nasal intubation using King Vision video laryngoscope Device after general anesthesia induction
15968111|NCT03126344|Device|McGrath MAC video laryngoscope|nasal intubation using McGrath MAC video laryngoscope Device after general anesthesia induction
15968112|NCT03126344|Device|Macintosh laryngoscope|nasal intubation using Macintosh laryngoscope Device after general anesthesia induction
15968113|NCT03126331|Drug|Nivolumab|"Nivolumab monotherapy will be administered dosed at 480mg IV over 30 minutes for all patients every 4 weeks, regardless of weight (when given in combination with ipilimumab, the dose of nivolumab is 3mg/kg every 3 weeks).
~Tumor assessed after 12 weeks If tumor decreases by 10% or more, then hold drug for 12 week and test tumor again. Continue treatment if tumor is not decreased by 10% or more."
15968114|NCT03126331|Drug|Ipilimumab|Ipilimumab is dosed at 1mg/kg over 30 minutes every 3 weeks
15968115|NCT03126318|Drug|COR-001|Anti-inflammatory therapy
15968116|NCT03126318|Drug|Placebo|Sterile water with a final buffer of 25 mM Histidine, 8.5% (w/v) trehalose and 0.05% PS80
15968117|NCT03126305|Other|OC-Go|OC-Go, a HIPAA-compliant web-based clinician portal and patient-side mobile application that allows clinicians to create and push tailored treatment assignments to patients on their mobile devices
15968118|NCT03126292|Behavioral|Sit Down and Play|Sit Down and Play (SDP) is designed to be a brief, low-cost intervention that incorporates key theoretical constructs to elicit positive parenting behaviors. It is intended to be delivered by existing clinical staff, nonprofessionals, or volunteers during each of the eight well-child visits between 2-24 months of age while a family waits to be seen by their pediatrician in the examination room.
15968119|NCT03126292|Other|Child Safety Handout|Handout regarding early child safety
15968120|NCT03126279|Procedure|Total Knee Replacement Surgery|All chronic knee osteoarthritis patients will be recruited as they are on the NHS waiting list for a total knee replacement. Only this group will undergo the procedure
15968121|NCT03126266|Radiation|re-irradiation|if DIPG has progressed or recurred at 180 days or later from completion of primary radiation therapy, a second course of radiation therapy will be given
15968122|NCT03126253|Diagnostic Test|Anemia|"Hemoglobin level will be used as the parameter for diagnosing anemia. The HemoCue system was used to estimate the concentration of hemoglobin in capillary blood. WHO guidelines for the diagnosis of anemia that were adopted by the Demographic Health Surveys will be used in this study. Briefly, a hemoglobin concentration of less than 70 g/L will be consider to define severe anemia, 70-99 g/L for moderate anemia, and 100-109 g/L will be presumed to correspond to mild anemia. The above-mentioned classification of anemia as severe moderate and mild categories is based on blood hemoglobin cutoffs (will be adjusted for altitude and smoking) recommended by the Center for Disease Prevention of United States; this classification has also been adopted by the World Health Organization."
15968123|NCT03126227|Biological|AR101|AR101 powder provided in capsules
15968124|NCT03126227|Biological|Placebo|Placebo powder provided in capsules
15968125|NCT03126214|Drug|Anticoagulants|Anticoagulant therapy will be initiated/titrated in patients with atrial fibrillation in accordance with the Canadian Cardiovascular Society Guidelines for Atrial Fibrillation.
15968126|NCT03126188|Drug|Sertraline|Tab. Sertraline 50 mg/day, which will be optimized to 75mg/day after 2 weeks if required, and maintained on the same dose for a minimum period of 6 weeks.
15968396|NCT03123952|Drug|ABT-414|ABT-414 will be administered by intravenous infusion
15968127|NCT03126188|Drug|Dosulepin|Tab. Dosulepin 25mg/day, which will be gradually hiked up to 75mg/day over 2 weeks,and the patients will be continued on the same dose for a minimum period of 6 weeks.
15968128|NCT03126188|Drug|Venlafaxine|Tab. Venlafaxine 75mg/day, which will be hiked to 112.5 mg/day after 2 weeks, and the patients will be continued on the same dose for a minimum period of 6 weeks.
15968129|NCT03126175|Device|Below elbow immobilization|20cm wide gypsum in the forearm cut to fit the thumb.
15968130|NCT03126175|Device|Above elbow immobilization|20cm wide gypsum in the forearm cut to fit the thumb associated a elbow splint made with a 15cm width on the ulnar aspect of the forearm that begins at the middle of the forearm and extends into the armpit.
15968131|NCT03126162|Procedure|InstilIing normal saline into bladder|Backfilling the bladder with 200 mL of normal saline immediately postoperatively, prior to foley catheter removal, after same-day total laparoscopic hysterectomy can potentially increase time to first spontaneous void and time to discharge.
15968132|NCT03126162|Procedure|Removal of foley catheter|Removal of the foley catheter is routinely performed after same-day laparoscopic hysterectomy
15968133|NCT03126149|Drug|PF-06667272|Single ascending dose of PF-06667272
15968134|NCT03126149|Other|Placebo|Single dose of placebo
15968135|NCT03126136|Device|Nicom (TM)|Heart rate, arterial pressure and cardiac output measurements (monitor NICOM) performed in the dorsal decubitus position and in the left lateral decubitus
15968136|NCT03126123|Procedure|acetic acid test|Patients will receive acetic acid on the mucosa of the anal canal before the surgical procedure
15968137|NCT03126110|Drug|INCAGN01876|In Phase 1 subjects will receive INCAGN01876 administered intravenously (IV) at the protocol-defined dose according to cohort enrollment. In Phase 2, subjects will be administered IV study drug at the recommended dose from Phase 1.
15968138|NCT03126110|Drug|Nivolumab|Nivolumab will be administered IV at the protocol-defined dose according to assigned treatment group.
15968139|NCT03126110|Drug|Ipilimumab|Ipilimumab will be administered IV at the protocol-defined dose according to assigned treatment group.
15968140|NCT03126097|Drug|JNJ-64155806 150 mg|JNJ-64155806 150 mg (3*50 mg tablet) twice daily will be administered under fed conditions on Days 1 to 7 [JNJ-64155806 Alone Phase] and on Days 60 to 66 [JNJ-64155806 + COCP Coadministration Phase].
15968141|NCT03126097|Drug|Ethinylestradiol/drospirenone 0.02 mg/3 mg|Each tablet contains 3 mg drospirenone and 0.02 mg ethinylestradiol administered as combined oral contraceptive pill (COCP) given on Days 18 to 41 (lead-in phase), Days 46 to 69 (coadministration phase - Days 59 to 66 under fed conditions).
15968142|NCT03126097|Drug|COCP Placebo|Participant will receive COCP placebo tablets once daily on Days 42 to 45 (lead-in phase) and Days 70 to 73 (JNJ-64155806 + COCP coadministration phase).
15968143|NCT03126084|Drug|Acetaminophen|1000 mg of intravenous acetaminophen will be administered twice a day
15968144|NCT03126084|Drug|0.25% Bupivacaine|20 ml of 0.25% bupivacaine will be administered to the fascia of the transversus abdominis muscle under ultrasound guidance.
15968145|NCT03126084|Drug|0.5% Bupivacaine+Glucose|15mg of 0.5% bupivacaine will be administered to subarachnoid space through 25G spinal needle
15968146|NCT03126084|Drug|Tramadol HCl|50mg of intramuscular tramadol will be administered when pain score is greater than 3 according to NRS
15968147|NCT03126084|Procedure|Inguinal Hernia Repair|Patients will undergo open inguinal hernia repair with one of the tension free mesh techniques
15968148|NCT03126084|Drug|0.25% Bupivacaine|10 ml 0.25% bupivacaine will be administered quadratus lumborum muscle and erector spinae muscle
15968149|NCT03126071|Drug|Raltitrexed|Raltitrexed:3mg/m2,iv 15min,d1,q3w.
15968150|NCT03126071|Drug|Irinotecan|Irinotecan:250mg/m2,iv 90min,d1,q3w.
15968151|NCT03126071|Drug|Oxaliplatin|Oxaliplatin:130mg/m2,iv 120min,d1,q3w.
15968152|NCT03126071|Drug|Bevacizumab|Bevacizumab:75mg/kg,iv 30min,d1,q3w.
15968153|NCT03126058|Procedure|enhanced recovery after surgery|Patients will undergo enhanced recovery after surgery programs.
15968154|NCT03126045|Device|Standard needle|"Patients will perform a spinal punction with a standard needle, used in the usual practice. The standard needles have the following characteristics : BD 22 G x 3 ½ in, 90mm, Quincke spinal needle, Black hub.
~When more than 2 attempts for lumbar puncture fail, the investigator will proceed with standard techniques (BD 20G x 3 ½ in, Quincke spinal needle, 90mm, yellow hub). This is a failed lumbar puncture."
15968155|NCT03126045|Device|Atraumatic needle|"Patients will perform a spinal punction with an atraumatic needle, used in the hematological service of the Lucien Neuwirth Cancerology Institute. The atraumatic needles have the following characteristics : Vygon 24 G × 3 ½ in, 90mm, Whitacre Pencil Point Spinal Needle, Purple hub.
~When more than 2 attempts for lumbar puncture fail, the investigator will proceed with standard techniques (BD 20G x 3 ½ in, Quincke spinal needle, 90mm, yellow hub). This is a failed lumbar puncture."
15968156|NCT03126032|Other|GlycoCheck™-System|"Consecutive, sublingual measurements of endothelial glycocalyx with GlycoCheck™-System will be obtained at presentation, as well as during the inpatient treatment of the patients with suspected sepsis.
~Blood sample will be drawn in all groups at time of assessment. Besides that, in patients with suspected sepsis blood samples will be drawn for further microbiologic and laboratory analysis at day 1 and day 7 of their hospital stay."
15968157|NCT03126019|Drug|Parsaclisib|Parsaclisib at the protocol-defined starting dose for 8 weeks, followed by Parsaclisib at the protocol-defined dose QD
15968158|NCT03126019|Drug|Parsaclisib|Parsaclisib at the protocol-defined starting dose for 8 weeks, followed by Parsaclisib at the protocol-defined dose once weekly
15968159|NCT03126006|Procedure|NSPT plus oral hygiene|Non-surgical periodontal therapy under local anesthesia to remove plaque and calculus
15968160|NCT03126006|Other|Oral hygiene alone|It includes pregnant women (with periodontal disease) who will not be given any mechanical treatment such as non-surgical periodontal therapy during pregnancy. However, oral hygiene instructions will be given.
15968161|NCT03125993|Behavioral|>10000 steps brisk walking|This study is a prospective 4-month follow-up scheme in which patients were treated with the following intervention: > 10000 steps, > five days, per week brisk walking.
15968266|NCT03125252|Other|Bundle|"Awakening and Breathing Coordination Delirium monitoring and management (detection and management of delirium) Early mobility
~Factors of environment:
~thirst
~noise
~pain and well-being
~sleep
~isolation"
15968430|NCT03123666|Drug|GMCSF|GM CSF (Sargamostatim-250mcg/M2) over 4 hour and inhalation of same dose by micronebulizer
15968162|NCT03125980|Drug|capecitabine plus oxaliplatin before and after surgery|"Subjects will receive systemic CapeOX chemotherapy both before and after the radical surgery for at most 4 cycles respectively. They shall have rest after the surgery for at least four weeks before the post-operative chemotherapy. CapOX regimen will be administered as follows:
~Oxaliplatin 130 mg/m2 iv continue for 2 hours.D1
~Capecitabine 1000mg/m2/d PO Bid,once every morning and evening D1-14
~Repeat every 3 weeks (Q3W)"
15968163|NCT03125980|Drug|capecitabine plus oxaliplatin after surgery|"Subjects will first receive radical surgery, then have rest for at least four weeks. Thereafter, subjects will receive systemic CapeOX chemotherapy for at most 8 cycles. CapOX regimen will be administered as follows:
~Oxaliplatin 130 mg/m2 iv continue for 2 hours.D1
~Capecitabine 1000mg/m2/d PO Bid,once every morning and evening D1-14
~Q3W"
15968164|NCT03125967|Other|Philips GoLite Blu HF3429/60|Exposure to daily morning colored light in the 440-485 nm wavelength range
15968165|NCT03125967|Other|Philips LivingColor Aura 70998/60/48|Exposure to daily morning colored light in the 625-740 nm wavelength range
15968166|NCT03125954|Other|standardized exercise treatment for knee OA in Denmark (GLAiD)|objective measurement of physical activity before, during af after the GLAiD intervention
15968167|NCT03125941|Drug|Dexamethasone|pre-operative intravenous administration
15968168|NCT03125928|Drug|Atezolizumab|Monoclonal antibody
15968169|NCT03125928|Drug|Paclitaxel|Chemotherapy
15968170|NCT03125928|Drug|Trastuzumab|Monoclonal antibody
15968171|NCT03125928|Drug|Pertuzumab|Monoclonal antibody
15968172|NCT03125915|Behavioral|Communication skills training video|This video includes 4 scenes of gay couples discussing issues related to HIV prevention, testing, sexual agreements, and drug use. Each scene is viewed twice. The first viewing includes common communication errors. The second viewing portrays more skillful interpersonal communication and a more adaptive resolution to the conversation.
15968173|NCT03125915|Behavioral|substance use module|This activity involves completion of a calendar detailing partners' substance use in the past month and a structured debriefing activity designed to facilitate the formation of couples' goals and limits around substance use.
15968174|NCT03125915|Behavioral|Couples HIV Testing and Counseling|CHTC delivered as per the CDC protocol.
15968178|NCT03125889|Device|AquaBeam System|The AquaBeam system delivers a high-velocity saline stream under precise electromechanical control and live ultrasound guidance to ablate prostatic glandular tissue without the production of heat. The physician uses ultrasound imaging to plan the treatment contour and depth to define the treatment region. The AquaBeam ablates the target tissue, adhering to the pre-defined treatment zone.
15968179|NCT03125876|Drug|CT053PTSA|receive oral CT053PTSA once daily until disease progression or unacceptable toxicity occurs, each cycle is defined as 28 days
15968180|NCT03125863|Device|AquaBeam System|The AquaBeam system delivers a high-velocity saline stream under precise electromechanical control and live ultrasound guidance to ablate prostatic glandular tissue without the production of heat. The physician uses ultrasound imaging to plan the treatment contour and depth to define the treatment region. The AquaBeam ablates the target tissue, adhering to the pre-defined treatment zone.
15968181|NCT03125850|Other|randomized to day ward|Participants will be randomized to day-ward group, and will accept routine treatment, care, centralized education of glaucoma knowledge
15968182|NCT03125850|Other|randomized to inpaitent|Participants will be randomized to day-ward group, and will accept routine treatment, care, centralized education of glaucoma knowledge
15968183|NCT03125824|Device|Soliton Acoustic Wave Device|Treatment of tattoos with Soliton Acoustic Wave Device as an accessory to laser
15968184|NCT03125811|Other|Inhaled Isopropyl Alcohol (IPA)|Three doses within 60 minutes. Doses will occur at 0 minutes, 30 minutes, and 60 minutes. Each dose consists of 3 inhalations of one IPA prep pad. A new prep pad is used at each dose.
15968185|NCT03125811|Drug|Oral Dissolvable Tablet Zofran (ondansetron)|Single dose 4 mg tablet at 0 minutes.
15968186|NCT03125798|Device|LigaSure™|LigaSure™ is supposed to provide improved closure of lymphatic and blood vessels during mediastinal lymph nodes dissection.
15968187|NCT03125798|Device|Monopolar electrocautery|Monopolar electrocautery will be used according to the standard technique for the mediastinal lymph node dissection.
15968188|NCT03125772|Device|TAXUS Element™ Paclitaxel-Eluting Stent System|Texus Element is the next generation Boston Scientific paclitexel-eluting coronary sten and received DCGI approval on April 13th, 2010.
15968189|NCT03125772|Device|Xience PRIME Everolimus-Eluting Stent System|The Everolimus-eluting stent manufactured and distributed by Abbott Vascular Santa Clara, CA, as Xience Prime.
15968190|NCT03125746|Drug|LXI-15029|The investigational product for this study is LXI-15029 capsule, which can be administered orally and the specification included 10 mg and 50 mg. There will be about 6 cohorts during the monotherapy period. LXI-15029 capsules will be administered in a therapeutic cycle of 28 days twice a day orally. The patients will be given LXI-15029 continuously, in a therapeutic cycle of 28 days. Patients will continue therapy with LXI-15029 if good safety and tolerability were assessed by investigators after 1 cycle treatment. The treatment will continue until progression or occurrence of unmanageable toxicity.
15968191|NCT03125746|Drug|LXI-15029+Exemestane|The combined drug in the combined therapy period of this study (investigational product) is Exemestane tablet (specification 25 mg). Exemestane should be taken at similar time every day in case of multiple doses (Cycle 1 Day 1 to Cycl 1 Day 28). If one dose was missed (e.g., forgetting, vomiting, etc.), this dose could not be made up and should be administered at next scheduled time point. And the dose of LXI-15029 will be determinated by safety review committee after dose escalation
15968267|NCT03125252|Other|Standard Paramedical and Medical practices|"The current recommendations recommend the following scheme:
~Identification and correction of an organic cause / factors (sepsis, metabolic disorders, withdrawal syndrome, pain)
~Use of non-pharmacological means (early mobilization, correction of sensory deficits, temporo-spatial reorientation strategies)
~Use of reference antipsychotic pharmacological means"
15968192|NCT03125733|Procedure|Submucosal tunneling endoscopic septum division|"STESD includes 4 steps:
~Mucosal incision: submucosal injection of normal saline-indigo carmine solution is performed 2-3cm proximal to the diverticular septum and a 1.5-2cm longitudinal mucosal incision is made using the endoscopic knife.
~Submucosal tunneling: a submucosal tunnel is created using the same technique as applied by Peroral Endoscopic Myotomy (POEM) at both sides of the septum until 1-2cm distal to the bottom of the diverticulum.
~Septum Division: cricopharyngeal myotomy is performed longitudinally along the mid-line of the septum and ends in the normal esophageal muscle.
~Mucosal Closure: the mucosa incision, as well as any accidental mucosotomy if present, is closed with hemostatic clips."
15968193|NCT03125720|Other|Image fusion of SPECT MPI and fluoroscopy venography|In this study, MPI-Fluoro Fusion tool is used to help the implanting physicians to precisely implant LV lead to the optimal/suboptimal venous segments in the guided group.
15968194|NCT03125707|Other|Registry study|
15968195|NCT03125694|Drug|Sitagliptin 100mg|Sitagliptin arm took sitagliptin 100 mg daily in combination with metformin 500 mg QID and gliclazide 80 mg TDS for 52 weeks
15968196|NCT03125694|Drug|Pioglitazone 30 mg|Pioglitazone arm took pioglitazone 30 mg daily in combination with metformin 500 mg QID and gliclazide 80 mg TDS for 52 weeks
15968197|NCT03125681|Procedure|Remote ischemic conditioning|In the RIC group, RIC is performed before and after coronary anastomoses by 5 minutes limb ischemia and reperfusion with pneumatic cuff up to 200 mmHg repeated by four times.
15968198|NCT03125681|Procedure|Control|In the control group, all the procedures will be same with RIC group, except for the fact that the three-way stopcock between the pneumatic cuff and the cuff inflator was opened and therefore the cuff pressure did not increase.
15968199|NCT03125668|Behavioral|Educational Program|At the hospitalization, patients receive the educational program with Power Point®Slides, booklets and orientation about the use of warfarin.
15968200|NCT03125668|Behavioral|Telephone follow-up|"After hospital discharge they receive a telephone follow-up (five calls for six months: 1st call in one week and the others calls month by month until six months).
~During the telephone calls the researcher talk with the patient about the topics that were approach in the educational intervention and motivate the patient to follow the recommendations for they have a successful treatment."
15968201|NCT03125668|Behavioral|Face to face counseling|They receive two face to face counseling (1st meeting in three months and the 2nd meeting in six months after hospital discharge). In the face to face counseling the researcher collect the data about anxiety and depression again, health-related quality of life and adverse events related to oral anticoagulation therapy.
15968202|NCT03125655|Diagnostic Test|Inflammatory markers|
15968203|NCT03125642|Drug|Etoposide|"BEAM: 100 mg/m^2 IV over 2 hours BID on Days -5, -4, -3, -2 | CBV: 150 mg/m^2 intravenously over 4 hours every 12 hours starting at 6 a.m. and 6 p.m. on Days -6, -5, -4"
15968204|NCT03125642|Drug|BCNU|BEAM & CBV: 300 mg/m^2 IV over over 2 hours on Day -6
15968205|NCT03125642|Drug|AraC|BEAM: 100 mg/m^2 IV over 1 hour BID on Days -5, -4, -3, -2
15968206|NCT03125642|Drug|Melphalan|BEAM: 140 mg/m^2 IV over 20 minutes on Day -1
15968207|NCT03125642|Procedure|Peripheral blood stem cell transplantation|All Arms: Day 0 infuse PBSC. All patients will have PBSC collected by leukapheresis. Mobilization will be done with G-CSF.
15968208|NCT03125642|Biological|G-CSF|All patients should receive G-CSF, 5 ug/kg/day IV as a bolus injection each evening beginning on day +5 until the ANC is >2500 x 10^9/L for 2 consecutive days. G-CSF will subsequently be restarted at 5 ug/kg/day SC or IV if the ANC falls below 1000/mm^3
15968209|NCT03125642|Drug|Cyclophosphamide|"CBV: 1.5 gm/M^2 over 2 hours at 10 a.m. on Days -6, -5, -4, -3 | CY/TBI: 60 mg/kg IV over 2 hours on Days -7, -6"
15968210|NCT03125642|Radiation|Total Body Irradiation|CY/TBI: 165 cGy bid on Day -4, -3, -2, -1
15968211|NCT03125629|Drug|F-18 FDG|Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging
15968212|NCT03125629|Drug|Ga-68-DOTA-TATE|Radiolabel for positron emission tomography / computed tomography (PET/CT) and computed tomography (PET/CT) imaging
15968213|NCT03125629|Device|Positron Emission Tomography / Computed Tomography (PET/CT) Scan|Scan using a regular medical care (IDE-exempt) Discovery 600 / 690 PET/CT scanner.
15968214|NCT03125629|Device|Positron Emission Tomography / Magnetic Resonance Imaging (PET/MRI) Scan|Scan using a NOVEL GE PET/MRI scanner.
15968215|NCT03125616|Biological|4CMenB Vaccine|The infants will receive an intramuscular injection of the 4CMenB vaccine at 2 months
15968216|NCT03125616|Biological|4CMenB Vaccine|The infants will receive an intramuscular injection of the 4CMenB vaccine at 3 months
15968217|NCT03125616|Biological|4CMenB Vaccine|The infants will receive an intramuscular injection of the 4CMenB vaccine at 4 months
15968218|NCT03125616|Biological|4CMenB Vaccine|The infants will receive an intramuscular injection of the 4CMenB vaccine at 12 months
15968219|NCT03125603|Other|Consultation of the patient's medical files at the hospital|Gradation of the adverse events according to CTCAE scale 4.03 (June 2010).
15968220|NCT03125590|Other|Testing the PEQ (Personalized Exercise Questionnaire)|Administer the questionnaire to 114 participants to classify their facilitators, barriers and preferences to exercise
15968221|NCT03125577|Biological|4SCAR19 and 4SCAR22|4SCAR19 and 4SCAR22
15968222|NCT03125577|Biological|4SCAR19 and 4SCAR38|4SCAR19 and 4SCAR38
15968223|NCT03125577|Biological|4SCAR19 and 4SCAR20|4SCAR19 and 4SCAR20
15968224|NCT03125577|Biological|4SCAR19 and 4SCAR123|4SCAR19 and 4SCAR123
15968225|NCT03125577|Biological|4SCAR19 and 4SCAR70|4SCAR19 and 4SCAR70
15968226|NCT03125577|Biological|4SCAR19 and 4SCAR30|4SCAR19 and 4SCAR30
15968227|NCT03125564|Procedure|Fecal Microbiota Transplantation|Fecal microbiota transplantation
15968228|NCT03125564|Procedure|Sham|Infusion of sham
15968229|NCT03125564|Procedure|Fecal and Mucosal Microbiota Assessment|To assess the fecal and mucosal microbiota before and after Fecal Microbiota Transplantation
15968230|NCT03125551|Dietary Supplement|Ginger|Ginger dosage at daily recommended allowance
15968231|NCT03125551|Dietary Supplement|Garlic|Garlic dosage at daily recommended allowance
15968232|NCT03125551|Dietary Supplement|Ginkgo Biloba|Ginkgo Biloba dosage at daily recommended allowance
15968233|NCT03125551|Dietary Supplement|Ginseng|Ginseng dosage at daily recommended allowance
15968234|NCT03125551|Other|Placebo|Daily dosage strategy
15968235|NCT03125538|Other|Motor Imagery|"Together with physical rehabilitation performed with physiotherapists, participants from the experimental group will mentally rehearse 3 different locomotor exercises that they already physically performed beforehand.
~Exercise 1: 10m Walk
~Exercise 2: Timed Up and Go test (rise up from a chair, walk 3 meters, turn around, come back to the chair, turn around and sit down)
~Exercise 3: Stairs climbing test (climb up 4 stairs, turn around, climb down the for stairs)
~Two min of MIP will be scheduled 5 times/day, during rest periods, so that patients complete 10min of MIP per day."
15968236|NCT03125538|Other|Control Task|"Together with physical rehabilitation performed with physiotherapists, participants from the control group will spend equivalent time focusing on a cognitive task without impact on motor rehabilitation ((word scramble game).
~Two min of this cognitive task will be scheduled 5 times/day, during rest periods, so that patients complete 10min of control task per day."
15968237|NCT03125525|Device|Cefaly device|Use of Cefaly based upon the protocol of the approval study of the device, in which it is used once every day on the migraine prevention program
15968238|NCT03125512|Device|Night Shift positional device|Night Shift is a small, positional therapy device that is worn at the back of the neck using a latex free silicone rubber strap. The strap is adjustable and is secured with a magnetic clasp. When a supine position is detected, the device vibrates with increasing intensity till the subject changes to a non-supine position.
15968239|NCT03125512|Device|continuous positive airway pressure|Automated adjusting continuous positive airway pressure
15968240|NCT03125499|Other|Previous treated with TPX-100|No intervention, only observational
15968241|NCT03125486|Drug|SC belimumab 200 mg|Belimumab subcutaneous 200 mg will be supplied for compassionate use for the identified individual subject.
15968242|NCT03125473|Biological|VXA-G1.1-NN Oral Vaccine|The drug product will be provided as small white enteric-coated tablets. Multiple tablets will be administered to deliver the high total doses.
15968243|NCT03125460|Device|Xpert Bladder Cancer Monitor|in vitro diagnostic test for the recurrence of bladder cancer in patients that have been previously diagnosed with bladder cancer
15968244|NCT03125447|Other|speed and accuracy answer to visual stimuli|A yellow fish swimming over a blue-green background will appear on the screen of virtual glasses. The child will have to give as fast as possible the direction of the fish pushing the left or right button of a computer mouse
15968245|NCT03125434|Other|EOS full-spine, MRI, gait analysis|full-spine stereoradiography, high-resolution spine muscle MRI and 3D gait analysis will be performed
15968246|NCT03125421|Procedure|standard preventive methods of pressure sores|"During the control period, the following specific methods to prevent pressure sores in the prone position (in ARDS patients mechanically ventilated via tracheal route) will be these ongoing in each center and involve the following components: lower eyelid and ocular protection by any method, inclination of the body from the horizontal position, intermittent head mobilization to the right or to the left, and no use of specific device to prevent pressures sores at the head and/or thorax, and/or knees, and/or feet.
~The following nonspecific methods to prevent pressures sores will be performed at the discretion of each center according to its usual practice: mattress, upper eyelid protection, main devices securely fasten, arms position, abdomen supported or not, mouth care, enteral nutrition continued in the prone position, skin protection and/or massage."
15968247|NCT03125421|Procedure|experimental multifaceted preventive methods of pressure sores|"During the experimental period, the following specific methods to prevent pressure sores in the prone position (in ARDS patients mechanically ventilated via tracheal route) will be systematically applied: lower eyelid protection by horizontal strap, ocular protection by methylcellulose, 15° inclination of the body from the horizontal position, intermittent head mobilization to the right or to the left every four hours, and use of specific device to prevent pressures sores at the head, thorax, knees, and feet.
~The following nonspecific methods to prevent pressures sores will be applied as in the control period described above except for the following: the abdomen will not be supported and the skin will not be protected."
15968248|NCT03125408|Diagnostic Test|HCV Assay|Molecular diagnostic test to detect Hepatitus C
15968249|NCT03125395|Drug|LUM/IVA|Participants received LUM/IVA every q12h.
15968250|NCT03125382|Device|Carelink System|Patients start to perform device data transmission through Carelink system
15968251|NCT03125382|Device|In office standard visit|Patients start or mantain in office standard visits
15968252|NCT03125369|Procedure|Sleeve gastrectomy + duodeno-jejunal bypass|
15968253|NCT03125369|Procedure|Roux-Y gastric bypass|
15968254|NCT03125356|Other|Diet Soda|Subjects will be asked to consume diet soda three times daily for eight weeks.
15968255|NCT03125343|Procedure|endoscopy|"Continuous follow-up. All patients with complete response will be followed for ten years. Details from the follow-up schedule will be registered in clinical record forms including information on the endoscopic findings, MRI findings and digital examination.
~They will be followed ever third month for the first two years as follows:
~PET-CT is optional, but can be performed at inclusion
~Pelvic MRI including diffusion weighted imaging according to appendix C.
~Clinical examination
~Endoscopy (flexible sigmoidoskopy) with photodocumentation
~CEA
~After two years the patients will be followed every six month with:
~Pelvic MRI including diffusion weighted imaging according to appendix as at baseline
~Clinical examination
~Endoscopy with photodocumentation
~CEA"
15968256|NCT03125343|Procedure|Surgery|Surgery according to recommendations from the multidisciplinary group in patients that prefer surgery to a watch and wait strategy
15968257|NCT03125343|Device|MRI|
15968258|NCT03125330|Behavioral|Professional coaching|Professional coaching is provided by the Principal Investigator via video conference.
15968259|NCT03125317|Other|Music|a kind of music which the participant likes will be listened using speakers
15968260|NCT03125317|Other|Valsalva maneuver|Participant will be asked to take a deep breath and exhale the air out in 15 seconds
15968261|NCT03125317|Other|control|No intervention
15968263|NCT03125291|Behavioral|Bridges 4-week Program|Participants receive 4, 2-hour sessions over a 6-week period.
15968264|NCT03125278|Other|Medication knowledge|Participants will be asked questions over the phone about their medications
15968268|NCT03125239|Drug|Merestinib|Oral, once a day, Merestinib Only- Lead in period on week. The followed by cycles on combination therapy with Merestinib and LY2874455 (28 days long)
15968269|NCT03125239|Drug|LY2874455|This will be followed by cycles of combination therapy with merestinib and LY2874455. Each of these cycles are 28 days long. • LY2874455 will be taken by mouth twice a day. You may take LY2874455 twice daily for 14 days, 21 days, or 28 days each cycle depending on the dose level you are assigned.
15968270|NCT03125226|Device|Polyethylene Glycol Hydrogel|Given TracelT hydrogel via injection
15968271|NCT03125213|Drug|AL-3778|AL-3778 tablets
15968272|NCT03125213|Drug|Peginterferon Alfa-2A|Peginterferon Alfa-2A for subcutaneous injection
15968273|NCT03125213|Drug|Placebo Oral Tablet|Placebo to Match AL-3778 tablet
15968274|NCT03125200|Drug|ADCT-502|Intravenous Infusion
15968275|NCT03125187|Biological|Sodium heparin UQ Intravenous drug administration|The participants will be hospitalized one day to receive the Sodium heparin UQ experimental medication or Sodium heparin FK comparator medication. They will receive the intravenous medication and start the blood collection at the programmed time. After 7 days, the participants will return to receive the other medication and have their blood collected. The last visit will be to collect safety datas
15968276|NCT03125187|Biological|Sodium heparin FK Intravenous drug administration|The participants will be hospitalized one day to receive the Sodium heparin FK comparator medication or Sodium heparin UQ experimental medication. They will receive the intravenous medication and start the blood collection at the programmed time. After 7 days, the participants will return to receive the other medication and have their blood collected. The last visit will be to collect safety datas
15968277|NCT03125161|Drug|HAI|HAI
15968278|NCT03125161|Drug|chemotherapy ± target therapy|chemotherapy ± target therapy
15968279|NCT03125148|Device|Enteral stenting|Enteral stent for malignant duodenal obstruction
15968280|NCT03125135|Device|MightySat RX Pulse Oximeter Sensor|Noninvasive pulse oximeter finger sensor.
15968281|NCT03125083|Biological|Biological dosage from plasma|The purpose of this study is to determine the role of inflammation in the high prevalence of psychiatric disorders in skin-restricted lupus (SRL) patients. SRL is an inflammatory disease. Inflammation can lead to a decrease in the synthesis of neurotransmitters via the activation of the IDO enzyme and to induce the synthesis of neurotoxic molecules (kynurenin pathway). This leads to the development of psychiatric disorders.
15968282|NCT03125070|Other|Best Practice and Internet site with links to existing resources|Receive usual care
15968283|NCT03125070|Other|Internet, Mobile app and Telehealth Intervention|Receive INSPIRE and survivorship care plan
15968284|NCT03125070|Other|Survey Administration|Ancillary studies
15968285|NCT03125057|Drug|Hemoporfin PDT|Photodynamic therapy is performed using hemoporfin. Hemoporfin（5mg/kg）is infused for 20 minutes, followed by light illumination at 10 minutes from the start of infusion. Different light dose of PDT is applied to the patients.
15968286|NCT03125031|Device|Rainbow adhesive adult/pediatric sensor|
15968287|NCT03125031|Device|Rainbow adhesive adult/neonatal sensor|
15968288|NCT03125018|Device|LNCS ADTX Sensor|Noninvasive pulse oximeter sensor.
15968289|NCT03125005|Device|Rainbow Universal Pulse Oximeter Sensor|
15968290|NCT03124979|Device|LNCS DBI Sensor|Noninvasive Measurement of SpO2
15968291|NCT03124966|Device|Pulse Oximeter sensor|
15968292|NCT03124927|Device|DCI pulse oximeter sensor|
15968293|NCT03124914|Other|Neuromuscular tests|Neuromuscular tests
15968294|NCT03124901|Device|DCI pulse oximeter sensor|
15968296|NCT03124862|Device|ARM sensor|Acoustic Monitoring sensor that monitors respiratory rate
15968297|NCT03124836|Device|Pulse Oximeter Sensor|
15968298|NCT03124823|Device|Rainbow DCI Sensor|Noninvasive pulse oximeter sensor
15968299|NCT03124797|Device|RD DCI Sensor|Noninvasive pulse oximeter sensor
15968300|NCT03124784|Device|RD Disposable Sensors|Noninvasive pulse oximeter sensor
15968301|NCT03124771|Device|Rainbow Resposable Adhesive Sensors|Noninvasive Measurement of SpHb
15968302|NCT03124758|Device|Hemoglobin Sensor ((Rainbow Reusable DCI, DCIP))|Measurement of Noninvasive Hemoglobin (SpHb)
15968303|NCT03124693|Device|Rainbow DCI pulse oximeter sensor|
15968304|NCT03124680|Combination Product|Opioid free|Peroperative opioid free anesthesia will be obtained via a combination of dexmedetomidine, ketamine, lidocaine and magnesium sulfate
15968305|NCT03124680|Combination Product|opioid group|Opioid anesthesia will follow the current standard approach of our hospital.
15968306|NCT03124667|Behavioral|Games|The game training will emphasize general and exercise-specific dual task processing, self-priming and certainty training.
15968307|NCT03124667|Behavioral|Videos|The video training will emphasize health and educational information.
15968308|NCT03124654|Behavioral|Education|Patients will receive several questionnaires to fill in. Knowledge about NOACs will be assessed with a newly developped questionnaire and an educational program will be dispensed while analysing the answers (reactive educational program).
15968309|NCT03124641|Device|Hypothermic oxygenated perfusion (HOPE)|HOPE for 1 hour via the portal vein in a recirculating and pressure controlled system (2-3 mm Hg), 0.1 ml/g liver/min, perfusion volume 3-4 L, Belzer (UW) machine perfusion solution, perfusate temperature 10 °C, perfusate oxygenation pO2 of 60-80 kPa
15968310|NCT03124641|Procedure|Conventional cold storage (CCS)|Conventional static cold storage (CCS) on temperature 4-6 °C from organ procurement
15968311|NCT03124628|Other|Flywheel resistance exercise|Flywheel resistance exercise, originally designed to maintain function, size and quality of skeletal muscle during spaceflight, employs iso-inertial technology rather than gravity dependent weights, which allows for coupled accommodated concentric and eccentric muscle actions, and brief episodes of eccentric overload.
15968312|NCT03124628|Other|Weight-stack resistance exercise|Conventional weight-stack resistance exercise
15968313|NCT03124615|Drug|Enzalutamide|Enzalutamide is a FDA and Therapeutic Goods Administration (TGA, Regulatory Authority of therapeutic goods in Australia) approved treatment for castration resistant prostate cancer
15968314|NCT03124602|Device|Red Diamond Disposable Pulse Oximeter Sensor|Noninvasive Pulse Oximeter Sensor
15968315|NCT03124589|Behavioral|Online Gambling Internet Intervention|CAMH's online gambling intervention which includes self-help materials as well as a personalized feedback component.
15968316|NCT03124576|Device|Implantable loop recorder|Continuous rhythm monitoring Medtronic
15968317|NCT03124563|Behavioral|Control Group|Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants in this condition will begin receiving daily emails asking them to report their step count in a questionnaire. Participants in the control group will be matched with the intervention group for how much contact they have with the researcher.
15968318|NCT03124563|Behavioral|Implementation Intention Condition|Participants will wear a Fitbit Zip for 5 weeks to record their daily activity data. The first week of the study will provide a baseline measurement of activity. After this week, participants will be asked to increase their steps incrementally by 2,000 steps each week for the subsequent four weeks. To help achieve their step goals, they will receive maps of different routes near their home and/or work of varying distances and step counts. They will be asked to review their schedule for the next day and identify times when they could add steps into their schedules, and to record their daily step data in the daily questionnaire.
15968319|NCT03124550|Behavioral|Exergame Experience|Fitbit Charge HR will be used to measure physical activity and sedentary behavior during waking hours. Each participant will wear a Fitbit for a period of one week at baseline and during the entire 6-week pilot study. Data on step counts, heart rate, and moderate/vigorous activity from the Fitbits will be transmitted wirelessly to our secure research server and will be used to assess changes in physical activity and sedentary behavior over the course of the study. Participants will be instructed to wear the monitor continuously on the wrist. Data will be analyzed using previously validated accelerometer count cut-points for adults after accounting for invalid data and wear time.
15968320|NCT03124537|Behavioral|App Experimental condition|This group were given the app to 1) count their steps, 2) add walks to their daily schedules, 3) create maps of their walking routes, and 4) text friends to invite them for a walk. Participants are asked to set a daily step goal and they can see how many steps they've taken each day since using the app. 2) There is an interface where participants can create maps based on walking routes. 3) They will also have the option to use a daily schedule to plan certain times in the day that they can walk. 4) The social feature gives participants the option to message friends, co-workers, or neighbors in one's contact list to invite them for a walk. They were also asked to respond to two questions twice a day about their mood and energy levels.
15968321|NCT03124537|Behavioral|App Condition Control|This group received the app with the first component, the ability to count steps and set daily step goals. This group will also be able to track walks to see the time, distance, and steps of each walk, but not see these walks displayed as a map. This group will monitor their daily steps over a one-month period, and will be asked to use the app as much as possible. They were also asked to respond to two questions twice a day about their mood and energy levels.
15968322|NCT03124524|Drug|estradiol valerate/dienogest|oral, 28 tablets including 2 tablets of 3mg estradiol valerate, 5 tablets of 2mg estradiol valerate plus 2mg dienogest, 17 tablets of 2mg estradiol valerate plus 3mg dienogest, 2 tablets of 1mg estradiol valerate and 2 non hormonal tablets as placebo, respectively
15968323|NCT03124524|Drug|ethinylestradiol and drospirenone|oral,0.03 mg ethinylestradiol and 3 mg drospirenone (21 tablets)
15968324|NCT03124511|Procedure|Surgery for breast cancer|Breast cancer resection performed via lumpectomy or mastectomy with or without sentinal node biopsy and axillary lymph node dissection.
15968325|NCT03124498|Biological|CIK Cell|Autologous cytokine-induced killer (CIK) cell
15968326|NCT03124485|Procedure|Endoscopic Sleeve Gastroplasty|An oesophageal overtube is then inserted to facilitate passage of the endoscope mounted with Overstitch device. A series of full thickness sutures done with Overstitch in the triangular stitch pattern as mentioned by Lopez-Nava[29] will be placed according to the APC markings. The suturing is initiated from the antrum distally and moved proximally towards the gastric fundus. A total of 6 to 8 plications are placed to reduce the gastric lumen. Five sham dressings would also be applied to patient's abdominal wall during the first week to minimize the bias in pain scoring.
15968327|NCT03124485|Procedure|Laparoscopic Sleeve Gastrectomy|Sleeve gastrectomy is then performed using lapaorscopic linear staplers, starting from a point 5-6cm proximal to the pylorus up to the angle of His along the left side of the Mid-sleeve tube. Haemostasis of the staple line is secured by suture plication with the Mid-sleeve tube in situ to ensure no compromise of the gastric tube lumen. All the wounds are closed with staples after local anaesthetic infiltration and covered with non-transparent dressings.
15968328|NCT03124472|Procedure|uterine artery ligation|Uterine artery ligation was performed by grasping the broad ligament with thumb anterior and the index finger lifting the base below the site uterine incision; the uterine artery was singly ligated with No. 1 vicryl suture. Myometrium was included so that uterine vessels are not damaged
15968329|NCT03124472|Procedure|Lower segment Cesarean section|"Pfannenstiel incision of skin and opening of the anterior abdominal wall in layers.
~- The loose peritoneum of the lower uterine segment is dissected downwards to mobilize the urinary bladder and expose the lower uterine segment.
~Cresenteric lower uterine segment incision was performed as usual. Higher incisions were performed in cases where the traditional incision was expected to be directly through the placenta Delivery of the baby and placenta.
~Closure of the uterine incision in 2 layers with N0. 1 vicryl suture.
~Closure of the anterior abdominal wall in layers"
15968330|NCT03124459|Drug|ACE-083|Part 1 - Recombinant fusion protein. Part 2 - Recombinant fusion protein or buffer solution.
15968331|NCT03124459|Drug|Placebo|Recombinant fusion protein or buffer solution
15968332|NCT03124446|Behavioral|Mindfulness-Based College|MB-College is an 8-week, 9-session curriculum providing systematic and intensive training in mindfulness meditation practices, applied to health behaviors relevant to college students. The curriculum is based on the manualized and standardized Mindfulness-Based Stress Reduction. The course builds a foundation of mindfulness self-regulation skills, including attention control, self-awareness and emotion regulation. It then directs those skills towards participants' relationships with health-related factors particularly salient in college undergraduates, including physical activity, diet, alcohol consumption, sleep, stress, social relationships, cognitive performance, and emotion regulation. Health behavior goal setting, and support for behavior change are integrated in the curriculum.
15968356|NCT03124303|Procedure|High Density-Electroencephalogram|EEG is a safe non-invasive technology without complications that may be used to help diagnose delirium
15968333|NCT03124446|Behavioral|Enhanced Usual Care Control|Participants in the enhanced usual care control group were spoken with by trained study staff, and as part of the enhanced usual care, were offered a referral to the study's psychiatrist and University counseling resources, if anxiety, depression, or suicidal ideation levels at baseline or follow-up reached clinical levels on the Beck Anxiety Inventory or the Revised Centers for Epidemiologic Studies Depression (CESD-R) scale. Participants in the control group were eligible to take the MB-College program during the following university term.
15968334|NCT03124433|Drug|Apalutamide|Participants will receive oral apalutamide 240mg daily for 12 weeks
15968335|NCT03124420|Drug|Lansoprazole|Group A: lansoprazole 30 mg b.i.d. for 7 days Group B: lansoprazole 30 mg b.i.d. for 14 days
15968336|NCT03124420|Drug|Amoxicillin|Group A: amoxicillin 1 g b.i.d. for 7 days Group B: amoxicillin 1 g b.i.d. for 14 days
15968337|NCT03124420|Drug|Clarithromycin|Group A: clarithromycin 500 mg b.i.d. for 7 days Group B: clarithromycin 500 mg b.i.d. for 14 days
15968338|NCT03124407|Drug|Capsaicin Topical Solution|Over-the-counter Tentative Final Monograph compliant product with 0.25% capsaicin
15968339|NCT03124407|Other|Drug product vehicle|This is the vehicle for the active treatment drug product, but without capsaicin
15968340|NCT03124381|Device|Cleanser, Acne Mask|A facial cleanser will be used twice daily (morning and evening). The light therapy mask will be used for 10 minutes in the evening after washing/drying the face.
15968341|NCT03124381|Device|Cleanser, Gel-Cream, Acne Mask|A facial cleanser will be used twice daily (morning and evening). In the evening after cleansing, the gel-cream will be applied full face and allowed to dry before the light therapy mask is used for 10 minutes.
15968342|NCT03124368|Drug|Danicopan|Participants received study drug for 14 days (Treatment Period), followed by a taper over the next 7 days (Taper Period).
15968343|NCT03124355|Drug|placebo sugar pill|placebo single oral dose
15968344|NCT03124355|Drug|Pyridostigmine Pill|pyridostigmine bromide 30 mg single oral dose
15968345|NCT03124355|Drug|Galantamine Pill|Galantamine hydrobromide 8mg single oral dose
15968346|NCT03124355|Device|Vagal stimulation|Vagal stimulation will be given at 50 Hz during the tilt table tests
15968347|NCT03124355|Device|Sham vagal stimulation|Sham vagal stimulation will be given at 0.01 mA during the tilt table tests
15968348|NCT03124342|Other|VANDERBILT ICU RECOVERY PROGRAM|"10-component ICU Recovery Program intervention, including:
~Nurse Practitioner In-Person Visit at the time of transfer from the ICU
~Provision of an ICU Recovery Program Pamphlet describing post-intensive care syndrome and providing online resources
~Performance of formal medication reconciliation at the time of transfer from the ICU
~Access to a dedicated 24-hour a day, 7-day a week contact line
~ICU Recovery Clinic Visit Medical Examination.
~ICU Recovery Clinic Medication Reconciliation and Counseling
~ICU Recovery Clinic Cognitive/Mental Health Assessment and Psychoeducation. A brief session of psychotherapy conducted by a clinical psychologist
~ICU Recovery Clinic Case Management. A brief case management consultation
~ICU Recovery Clinic Patient Centered Consultation. A final consultation with patients and families by a PCCM physician
~Directed Subspecialty Referrals"
15968349|NCT03124329|Procedure|Coronally Advanced Flap|Coronally advanced flap will be performed. Briefly, sulcular incisions will be made. Oblique incisions will be made on each papilla requiring root coverage. In the region coronal to the mucogingival junction (MGJ), mucoperiosteal flap will be elevated. Apical to the MGJ, sharp dissection will be performed to the periosteum allowing split-thickness flap elevation to be performed. Epithelium is removed from the papillae adjacent to the recession and the flap is coronally positioned and stabilized with interproximal sutures and apico-coronal interrupted sutures to close the vertical releasing incisions.
15968350|NCT03124329|Procedure|Intrasulcular Tunneling|Initial sulcular incisions are made and small, contoured blades and mini curettes are used to create the recipient pouches and tunnels. The tunnel will be subperiosteal in location. The incision is extended to one adjacent tooth both mesially and distally. This incision maintains the full height and thickness of the gingival component and enables access beneath the buccal gingiva. The connective tissue beyond the mucogingival line will be dissected and free the buccal flap from its insertions to the bone around each tooth. Muscle fibers and any remaining collagen fibers on the inner aspect of the flap, which prevent the buccal gingiva from being moved coronally, are cut. The papillae are kept intact and undermined to maintain their integrity and carefully released from the underlying bone, which allows the coronal positioning of the papillae. An envelope, full-thickness pouch, and tunnel are created and extended apically beyond the mucogingival line by blunt dissection
15968351|NCT03124329|Biological|Vestibular Incision Subperiosteal Tunnel Access (VISTA)|The VISTA approach begins with a Vestibular Incision Subperiosteal Tunnel Access. Through this incision a subperiosteal tunnel is created, exposing the facial osseous plate and root dehiscence. This tunnel will be extended at least one or two teeth beyond the teeth requiring root coverage to mobilize gingival margins and facilitate coronal repositioning. Additionally, the subperiosteal tunnel is extended interproximally under each papilla as far as the embrasure space permits, without making any surface incisions through the papilla. The mucogingival complex is then advanced coronally and stabilized in the new position with the coronally anchored suturing technique, which entails placing a horizontal mattress suture apical to the gingival margin of each tooth. The suture is tied to position the knot at the midcoronal point of the facial aspect of each tooth, which is secured with help of composite resin to prevent apical relapse of the gingival margin during initial stages of healing.
15968352|NCT03124329|Device|Leukocyte-Platelet Rich Fibrin (L-PRF)|"Immediately prior to surgery, 72 mL of blood should be drawn from each patient by venipuncture of the antecubital vein and collected in a sterile glass test tube without any anticoagulant. Tubes should be centrifuged at 2,700 rpm for 12 minutes within 2 minutes after blood draw. For individuals on anti-coagulant therapy or supplements to interfere with coagulation, centrifugation will be for 18 minute. After centrifugation, each L-PRF clot will be separated from the portion of red blood cells (red thrombus), obtaining a fibrin clot with a red small portion in order to include the buffy coat richer in leucocytes. The L-PRF clot is condensed and modeled on a sterile surgical plate. L-PRF will be used within 60 minutes after the preparation."
15968353|NCT03124316|Behavioral|Anticipated regret|Induce awareness of future regret about the unwanted behaviour
15968354|NCT03124316|Behavioral|Material incentive|Inform that valued objects will be delivered if and only if that has been progress in performing the desired behaviours
15968355|NCT03124316|Behavioral|Problem solving|Analyze or prompt the person to factors that influence the behaviour and select strategies that help overcome barriers
15968358|NCT03124290|Other|paced auditory serial addition test (PASAT)|A number between 1 to 9 is called every three seconds through a speaker, and the performer calculates the last two numbers and shouts the answer.
15968359|NCT03124277|Dietary Supplement|Fortifit®|Best local diet + two servings (40 grams each) of powder (Fortifit®; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers.
15968360|NCT03124277|Other|Control Group|Best local diet
15968361|NCT03124238|Other|Massage|Massage therapy localized to the back of the individuals for a duration of 30 minutes
15968362|NCT03124225|Drug|DMARD|
15968363|NCT03124212|Other|CASCADE genetic screening|Family-based cohort of mutation carriers, blood relatives who test negative, and untested blood relatives
15968364|NCT03124199|Drug|Rifaximin|Rifaximin 400 mg/8 h added to the standard triple therapy
15968365|NCT03124186|Device|S88 Dual Output Stimulator by Grass Technologies|Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy
15968366|NCT03124173|Other|Training session|The subjects will be trained to realize several versions of a learning task of conditional visuo-motor associations.
15968367|NCT03124173|Other|First fMRI session|In this session (involving a condition specific to man and a condition that we are certain to obtain in the monkey), subjects will have to learn by trial and error during successive trials, the conditional associations between three abstract stimuli and three Manual responses (3 MRI-compatible mouse buttons).
15968368|NCT03124173|Other|Second fMRI session|In this session (involving a condition specific to man and a condition that we are almost certain to obtain in monkeys), subjects will have to learn by trial and error during successive trials, the conditional associations between three abstract stimuli and Three orofacial responses (3 movements of the mouth).
15968369|NCT03124173|Other|Third session of fMRI|In this session (involving a human-specific condition and a condition we hope to achieve in the monkey), subjects will have to learn by trial-error in successive trials, conditional associations between three abstract stimuli and three verbal or Vocals.
15968370|NCT03124160|Drug|Mona Lisa® NT Cu380 Mini|Mona Lisa® NT Cu380 Mini
15968371|NCT03124160|Drug|ParaGard® CuT380A|ParaGard® CuT380A
15968372|NCT03124147|Device|Neuroconn Eldith stimulator by Magstim|Transcranial direct current stimulation to the ipsilesional hemisphere, contralesional hemisphere, or both, paired with task-oriented therapy.
15968373|NCT03124134|Device|Gelesis200|Encapsulated hydrogel
15968374|NCT03124134|Other|Water, only (placebo)|300 mL of water
15968375|NCT03124121|Drug|Golimumab|A biologic agent which acts by antagonising the effects of tumour necrosis factor (TNF) alpha
15968376|NCT03124108|Drug|Elafibranor 80 mg|Two coated tablets daily for 12 weeks
15968377|NCT03124108|Drug|Elafibranor 120 mg|Two coated tablets daily for 12 weeks
15968378|NCT03124108|Drug|Placebo|Two coated tablets daily for 12 weeks
15968379|NCT03124095|Behavioral|Combined exercise Group|The subjects of the combined training group will undergo the intervention three times a week for eight weeks. The combined group will carry out both resistance and aerobic exercises in the same session. The resistance training will be comprised by ten exercises which will alternate body segments with maximum repetitions in the first set and the lower limit of the repetitions interval in the next sets. Along the training, the number of series will be increased whereas the number of repetitions will be decreased. The intensity of the aerobic exercises will be based on the percentage of the heart rate of the anaerobic threshold on the first weeks and on the speed of the anaerobic and aerobic threshold on the last weeks
15968380|NCT03124082|Drug|Remifentanil|continuous infusion intraop
15968381|NCT03124082|Drug|Ketamine|bolus 0,5 mg/kg + infusion 0,25 mg/kg/h
15968382|NCT03124082|Drug|Lidocaine|lidocaine bolus 1 mg/kg + infusion 1 mg/kg/h
15968383|NCT03124082|Drug|Clonidine|clonidine 4 mcg/kg
15968384|NCT03124069|Device|F&P Saturn|Participants will be placed on this arm for a total of 14 ± 5 days from Visit 2. Participants will be using the trial nasal mask during this treatment arm.
15968385|NCT03124056|Device|Extracorporeal photopheresis|Extracorporeal photopheresis using non-open system
15968386|NCT03124043|Other|Livongo for Diabetes program|See description in arm/group description.
15968387|NCT03124030|Procedure|simple dental extraction|dental extraction is performed by an expert oral surgeon within 20 minutes. Non-resorbable suture are applied
15968388|NCT03124017|Other|Electronic alert and the Geneva Risk Score calculation tool issued in the electronic patient chart|
15968389|NCT03124004|Procedure|periodontal debridement|with ultrasonic device supragingival and subgingival full-mouth debridement is provided
15968390|NCT03123991|Behavioral|UP-A adapted as a preventive intervention|The Spanish Version of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) adapted as a school-based anxiety and depression preventive intervention. The UP-A (Ehrenreich-May et al., 2016) is a transdiagnostic anxiety and depressive disorders treatment protocol that implement a set of core principles to address common factors underlying youth anxiety and depressive symptoms in an individual setting. Core modules of the UP-A include: (1) Building and Keeping Motivation; (2) Getting to Know Your Emotions and Behaviors; (3) Behavioral Activation; (4) Sensational Awareness; (5) Being Flexible In Your Thinking; (6) Awareness of Emotional Experiences; (7) Situational Emotion Exposures and (8) Keeping it Going - Maintaining Your Gains.
15968391|NCT03123991|Behavioral|Same than experimental group (EG), after EG finishes|The Spanish Version of the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in Adolescents (UP-A) adapted as a school-based anxiety and depression preventive intervention. The UP-A (Ehrenreich-May et al., 2016) is a transdiagnostic anxiety and depressive disorders treatment protocol that implement a set of core principles to address common factors underlying youth anxiety and depressive symptoms in an individual setting. Core modules of the UP-A include: (1) Building and Keeping Motivation; (2) Getting to Know Your Emotions and Behaviors; (3) Behavioral Activation; (4) Sensational Awareness; (5) Being Flexible In Your Thinking; (6) Awareness of Emotional Experiences; (7) Situational Emotion Exposures and (8) Keeping it Going - Maintaining Your Gains.
15968392|NCT03123978|Drug|Enzalutamide|Given PO
15968393|NCT03123978|Drug|Niclosamide|Given PO
15968394|NCT03123965|Drug|glecaprevir|Glecaprevir will be administered orally.
15968395|NCT03123965|Drug|pibrentasvir|Pibrentasvir will be administered orally.
15968397|NCT03123939|Biological|CTL019|CTL019 transduced T cells were given as a single dose of 0.2 to 5.0 × 10^6 autologous CTL019 transduced viable T cells per kg body weight (for patients ≤ 50 kg) and 0.1 to 2.5 × 10^8 CTL019 transduced viable T cells (for patients > 50 kg)
15968398|NCT03123913|Drug|Testosterone Enanthate|Testosterone enanthate in oil (140mg) delivered via intramuscular injections every 2 weeks.
15968399|NCT03123913|Drug|Somatropin|Genotropin (5.0 μg/kg/day) delivered via subcutaneous injections.
15968400|NCT03123900|Behavioral|Physical exercise|The structured physical activity plan consists of a walking program with an initial progressive phase (first week: 30 minutes/session and second week: 45 minutes/session, with a Borg scale of perceived exertion between 9 and 10) and an improvement and maintenance phase (10 weeks, 45 minutes/session with a Borg scale of perceived exertion between 11 and 14).
15968401|NCT03123900|Behavioral|Cognitive training|We use a computerized cognitive training tele-medicine tool, designed by the Guttmann Institute: Guttmann Neuro Personal Trainer (PREVIRNET). Sessions will consist in activities of attention, memory and executive functions, also put in place progressively and parallel to the physical activity.
15968402|NCT03123900|Behavioral|Combined training|Subjects included in this group receive both types of intervention.
15968403|NCT03123887|Other|salvage therapy|VDC(L)P regimen or High-dose cytarabine based regimen or High-dose methotrexate based regimen or Hyper-CVAD regimen or FLAG (Flu, Ara-C, G-CSF) ± anthracyclines based regimen or Repeated original induction regimen or VDP or other
15968404|NCT03123874|Device|Sterile pump set-up|Medela symphony breast pump (model number 0240108) and disposable, sterile collection kits (model number 67399S).
15968405|NCT03123874|Device|Mother's Own pump set-up|Mother's own electric breast pump and own collection kit (previously used and cleaned at home using her usual practices).
15968406|NCT03123861|Drug|Gabapentin|Patients randomized to this arm will receive 2 weeks of gabapentin post-operatively.
15968407|NCT03123861|Drug|Placebo oral capsule|Patients randomized to this arm will receive 2 weeks of placebo post-operatively..
15968408|NCT03123848|Drug|Darunavir/Cobicistat|Participants will receive a FDC tablet of darunavir 800 mg and cobicistat 150 mg orally in the morning of Day 1.
15968409|NCT03123835|Procedure|Endoscopic Intervention|After reviewing all therapeutic options the patient will be offered the best therapeutic option to treat their condition. Surgical interventions include open laparotomy, diagnostic/therapeutic laparoscopy or endoluminal therapies. After the patient is consented for the related surgical intervention the patient will be given the option to participate in the clinical study to measure outcomes after surgery.
15968410|NCT03123822|Device|Glasses|Glasses traditionally prescribed for refractive error
15968411|NCT03123809|Device|Gastric Electrical Stimulation (GES) System|Implantable GES System will be turned ON as an active intervention providing electrical stimulation to the muscle of stomach for 6 months in patients from the first arm, versus 3 months only of active stimulation in patients who are randomized to be in the second arm of the study. GES works by utilizing following parameters: Current 5 mA; Pulse Width 330µsec; Rate 14 Hz; Time ON 0.1 sec; Time OFF 5.0 sec.
15968412|NCT03123783|Drug|APX005M|APX005M is a CD40 agonistic monoclonal antibody
15968413|NCT03123783|Drug|Nivolumab|Nivolumab is an immune checkpoint (PD-1) blocking antibody
15968414|NCT03123770|Drug|Pegylated liposomal doxorubicin|a new kind of doxorubicin
15968415|NCT03123770|Drug|Cyclophosphamide|traditional chemotherapy drug
15968416|NCT03123770|Drug|Epirubicin|traditional chemotherapy drug used in breast cancer
15968417|NCT03123770|Drug|Docetaxel|traditional chemotherapy drug used in breast cancer
15968418|NCT03123757|Other|6 Minute Walk Test|The 6 minute walk test measures the distance walked in 6 minutes without sitting and without the use of a walker or the help of another person (a cane may be used). The walk was conducted in a wide hallway, specifically designed for this type of assessment, with a defined 20-meter course. The subject walked back and forth in the hallway for six minutes and the distance covered was recorded.
15968419|NCT03123757|Other|EQ-5D Survey|The EQ-5D is a self-reported questionnaire that describes a respondent's health using a descriptive system comprised of five items, each representing a different health dimension (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, respondents state whether they have no problems, slight problems, moderate problems, severe problems, or are unable to perform the activity.
15968420|NCT03123757|Other|Short Physical Performance Battery|The SPPB is a brief performance battery based on timed short distance walk, repeated chair stands and balance test administered by trained examiners. The measurement goal for this battery is to assess lower extremity functional limitations, which indicate functional abilities and are a strong measure of risk for future disability.
15968421|NCT03123744|Drug|Palbociclib 125mg|Palbociclib 125 mg is administered orally at a starting dose of 125 mg/day for three weeks followed by one week off. Study evaluations include physical exams, performance status, vital signs, laboratory blood tests, and radiographic or MRI imaging.
15968422|NCT03123731|Behavioral|Control Arm|Wearing Physical Activity Monitor
15968423|NCT03123731|Behavioral|iSTEP|Physical Activity Intervention
15968424|NCT03123731|Behavioral|iSTEP|Physical Activity and Diet Intervention
15968425|NCT03123718|Drug|Intrathecal methotrexate|Intrathecal administration of 2nd, 3rd, and 4th doses of methotrexate 15 mg and hydrocortisone 50mg on day 2 or 3 of 2nd, 3rd, and 4th cycles of immunochemotherapy with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (RCHOP), respectively.
15968426|NCT03123718|Drug|High-dose intravenous methotrexate|"Intravenous administration of 1st and 2nd doses of methotrexate 3g/m2 on day 15 of 2nd and 6th cycles of immunochemotherapy with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (RCHOP), respectively.
~* Dose of intravenous methotrexate will be reduced to 2g/m2 for patients aged >70 years."
15968427|NCT03123692|Drug|Emeramide|Lipophilic, membrane passing Metal chelator and anti oxidant
15968428|NCT03123692|Drug|Placebo|14 days treatment with placebo
15968429|NCT03123679|Radiation|pulmonary perfusion/reserve with Tc-99m-MAA SPECT/ Low dose CT|"Patient referred to radiotherapy treatment are evaluated with a baseline PFT [Forced expiratory volume in 1 second (FEV1), Forced vital capacity (FVC), diffusing capacity of the lung for carbon monoxide (DLCO), Alveolar gas volume (VA)].
~RT simulation at the radiotherapy department and treatment planning.
~Baseline evaluation of pulmonary perfusion/reserve with Tc-99m-MAA SPECT/ Low dose CT.
~Radiotherapy."
15968432|NCT03123653|Drug|Peg IFN 2b|Peg IFN 2b 1.5mcg/kg once every week for 48 weeks
15968433|NCT03123640|Other|Medication reconciliation and medication review|Pharmacist performed medication reconciliation and medication review
15968434|NCT03123627|Drug|New profilaxis|Primary endpoint: incidence of CMV disease at 12 months after transplantation. Study the predictive value of the assay of CD8 + T cell immunity specific for defined CMV-patients in which they can stop prophylaxis. The definition of CMV disease was based on those recommended by the American Society of Trasnplantation for use in clinical trials (Humar A. Am J Transplant 2006; 6:262-74) criteria.
15968435|NCT03123627|Drug|Profilaxis recommended|Secondary end points: percentage of patients developing T cell immunity in CMV-specific transplantation after receiving timoglubulina induction and valganciclovir prophylaxis. T cell development inmnunidad CD8 + CMV-specific is defined as production of γ> 0.2 interferon by CD8 + T cells stimulated by CMV-specific CMV antigens (QF reagent).
15968436|NCT03123614|Drug|Loteprednol Etabonate 0.5% Oph Gel|
15968437|NCT03123614|Drug|Prednisolone Acetate 1% Oph Susp|
15968438|NCT03123601|Device|Risk sign displays|"Set of sign displays designed to communicate fall, dehydration and pulmonary aspiration risks and reflect on tailored interventions to manage these events in nursing homes. Risk sign displays are:
~Small, lightweight rubber coloured bracelets with phrases related with the different risks: prevent rather than fall, contain to protect, drink to hydrate and avoid choking.
~Small and coloured signposts next to head of patients bed that are believed to offer some key advantages and increase technically the quality of immediate communication of information and data regarding procedures. It is expected to have greater subject compliance once they will have discrete messages with thoughtful design and colour."
15968439|NCT03123588|Drug|Ruxolitinib|Ruxolitinib administered orally twice daily (BID) at the protocol-defined starting dose.
15968440|NCT03123588|Drug|Anagrelide|Anagrelide administered orally at a starting dose of 1 mg BID.
15968441|NCT03123588|Drug|Placebo|Anagrelide-placebo administered orally BID
15968442|NCT03123588|Drug|Placebo|Ruxolitinib-placebo administered orally BID.
15968443|NCT03123562|Combination Product|Stem cell transplantation|Transplantation of Autologous Bone Marrow Mononuclear Cells
15968444|NCT03123549|Device|Simplify Disc|Simplify Disc at two levels of the cervical spine
15968445|NCT03123536|Device|Point-of-care Ultrasound|Patients' management in the point-of-care ultrasound group will be adjusted according to the results of ultrasound, whereas patients in the control group the decisions about the management were made by the experience of clinical team.
15968446|NCT03123523|Diagnostic Test|Echocardiography at T0|
15968447|NCT03123523|Diagnostic Test|Exercise test|
15968448|NCT03123523|Biological|Biological assays|Creatinin, hematocrit and BNP assays
15968449|NCT03123523|Device|MRI with contrast agent injection|With injection of gadolinium
15968450|NCT03123523|Device|MRI without contrast agent injection|Without injection of gadolinium
15968451|NCT03123523|Diagnostic Test|Echocardiography at M24|
15968452|NCT03123510|Dietary Supplement|Bifidobacterium spp plus bimuno- galacto-oligosaccharides|Volunteers will be asked to take one probiotic capsule and one prebiotic satchel daily.
15968453|NCT03123510|Dietary Supplement|Placebo|Volunteers will be asked to take one placebo capsule and one placebo satchel daily.
15968454|NCT03123497|Other|completion of questionnaire|completion of questionnaire for patient and parent
15968455|NCT03123484|Drug|β-elemene|β-elemene：400-600mg + 5%GS 500ml,ivgtt,qd, continuously 45days
15968456|NCT03123484|Drug|EGFR-TKIs(Erlotinib, Gefitinib and Icotinib)|EGFR-TKIs(Erlotinib, Gefitinib and Icotinib) as usual
15968457|NCT03123471|Drug|Apremilast|Apremilast 30 mg tablets BID from weeks 0 to 32.
15968458|NCT03123471|Other|Placebo|Placebo tablets twice daily (BID) for 16 weeks; placebo participants were switched to apremilast 30 mg at week 16.
15968459|NCT03123458|Biological|clonal fetal MSCs|
15968460|NCT03123445|Drug|Endostar|Endostar,30mg continuous intravenous injection pump, d1-d7,21 days as one cycle, 4 cycles in total
15968461|NCT03123445|Drug|Gemcitabine|Gemcitabine,1000mg/m2, i.v, d1 and d8 in each cycle, 21 days as one cycle, 4 cycles in total
15968462|NCT03123445|Drug|Cisplatin|Cisplatin,75mg/m2, i.v, d1 in each cycle, 21 days as one cycle, 4 cycles in total
15968463|NCT03123432|Dietary Supplement|immunomodulating nutrients enriched diet|
15968464|NCT03123432|Dietary Supplement|standard diet|
15968465|NCT03123419|Behavioral|Appointment reminders|The purpose of the Gardasil study is to increase the rates of Gardasil vaccination in the Maternal Fetal Care Center. This will be done by reminding patients via text to come for their follow up vaccine appointments.
15968466|NCT03123406|Drug|Cinacalcet HCl|Administer Cinacalcet HCL to all subjects from 1st to 32nd week. Subjects choose to buy and take Cinacalcet HCL in real-world period from 33rd to 52nd week.
15968467|NCT03123393|Drug|TAK-659|TAK-659 Tablets
15968468|NCT03123367|Device|Group 1: Nella VuSleeve|Sleeve
15968469|NCT03123367|Device|Group 2: Nella NuSpec|Speculum
15968470|NCT03123367|Device|Group 3: NellaSpec|Speculum
15968471|NCT03123367|Device|Group 4: Nella Insert|Sleeve
15968472|NCT03123354|Device|O3 regional oximeter sensor|Noninvasive sensor that is placed on the forehead for measurement of oxygenation in the area under the sensor
15968473|NCT03123328|Device|Radical-7 Pulse CO-Oximeter and sensor|Noninvasive device that measures hemoglobin.
15968474|NCT03123315|Device|Ureteral Illuminating Catheter|This is a very thin tube that goes into a ureter to more effectively find and track the ureter during surgeries
15968475|NCT03123289|Drug|68-Gallium citrate PET/CT scan|After establishment of an intravenous access, approximately 5 mCi of 68Ga-citrate (Zevacor Molecular, Somerset, NJ, USA) will be administered intravenously. Whole body PET/CT scan will be performed after 60 minutes of uptake phase.
15968476|NCT03123289|Drug|18F FDG PET/CT scan|Subjects will undergo FDG PET/CT scan using the same imaging parameters either on the same day or within the next 24-48 hours. The subjects will be requested to fast for a minimum of 4 h prior to PET acquisition. After confirmation of a blood glucose level ≤200 mg/dl, technologists will establish the intravenous access and the subject will receive approximately 10 mCi of 18F-FDG (Zevacor Molecular, Somerset, NJ, USA) intravenously. The subject will be placed in uptake room for 60 minutes to allow for optimal localization of the compound. The subjects will be requested to void prior to administration of 18FDG and again prior to image acquisition.
15968477|NCT03123276|Drug|Pembrolizumab|humanized IgG4 PD-1 blocking antibody
15968478|NCT03123276|Drug|Gemcitabine|Doses of 800, 1000 and 1200 mg/m2 will be used in dose escalation phase.
15968479|NCT03123250|Device|Aquablation|To utilizes proprietary heat-free high-velocity waterjet technology to resect and remove prostate tissue using the AQUABEAM system, which is a personalized image-guided tissue removal system.
15968480|NCT03123237|Diagnostic Test|DMSA scan|We explore the possible role of DMSA to detect renal affection in diabetic &/or hypertensive patients by detecting difference in counts using Tc 99m DMSA in control & diabetic &/or hypertensive patients.
15968481|NCT03123224|Behavioral|Combined Aerobic and Resistance Exercise + Caregiver Skills Training|The combined moderate to high intensity combined aerobic and resistance exercise training + skills training group consists of six months of physical exercise + caregiver skills training followed by an additional six months of follow-up for a total study duration of twelve months. All aspects of these combined interventions will be delivered through mobile technology thus obviating some of the obstacles to caregivers face in meeting their own needs. Caregivers will be provided with study issued equipment (e.g., exercise equipment, activity monitoring devices, and tablets) to complete all elements of the intervention.
15968482|NCT03123224|Behavioral|Stretching Balance and Flexibility + Caregiver Skills Training|The stretching, balance and flexibility training + skills training group consists of six months of physical exercise + caregiver skills training followed by an additional six months of follow-up for a total study duration of twelve months. All aspects of these combined interventions will be delivered through mobile technology thus obviating some of the obstacles to caregivers face in meeting their own needs. Caregivers will be provided with study issued equipment (e.g., exercise equipment, activity monitoring devices, and tablets) to complete all elements of the intervention.
15968483|NCT03123211|Drug|Veliparib|Veliparib will be administered orally.
15968484|NCT03123198|Behavioral|Dialectical Behavior Therapy|DBT is a multimodal comprehensive psychosocial treatment.
15968485|NCT03123185|Drug|Placebo|Tablet and solution formulation
15968486|NCT03123185|Drug|BI 705564|Tablet and solution formulation
15968487|NCT03123185|Drug|BI 705564 (Test)|Fed state
15968488|NCT03123185|Drug|BI 705564 (Reference)|Fasting state
15968489|NCT03123172|Diagnostic Test|arterial and central venous blood gases|withdrawal of arterial and central venous blood gases to measure Co2 gap
15968490|NCT03123159|Diagnostic Test|DxN HBV Assay|Molecular diagnostic test to detect Hepatitis B
15968491|NCT03123146|Behavioral|Functional Behavior-Based Cognitive Behavioral Therapy|Fb-CBT involved nine 2-hour weekly sessions with three to four children in each group and two therapists. Therapy consisted of group activities, individual work in parent-child dyads, group parent training, and social skills exercises.
15968492|NCT03123120|Drug|Spesolimab|12 weeks treatment
15968493|NCT03123120|Drug|Placebo|12 weeks treatment
15968494|NCT03123107|Drug|Ascorbic Acid|Ascorbic acid doses will be mixed in 100 mL normal saline and infused over 60 minutes. The postoperative dose will be given on postoperative day #1.
15968495|NCT03123094|Drug|BI 655130|single dose
15968496|NCT03123094|Drug|Placebo|single dose
15968497|NCT03123081|Procedure|Umbilical Cord Milking|At birth the cord of a depressed newborn is clamped immediately and cut 30 cm from the umbilicus. After completion of initial steps, if required, positive pressure ventilation (PPV) is given for 30 seconds, along with UCM. The cord is untwisted and held in a vertical position. It is milked 3 times towards the baby at a speed of 10 cm/s and then clamped 3 cm from the umbilicus. After completion of PPV along with UCM, if the baby requires further resuscitation, the NRP 2015 guidelines will be followed. Depressed newborns who respond to initial steps of resuscitation with normal breathing and heart rate of 100 bpm or higher, will receive UCM after this.
15968498|NCT03123068|Drug|CocoaVia®|CocoaVia® is manufactured by Mars, Inc. It is a dietary supplement of cocoa bean extract, containing 125 mg cocoa flavanols per capsule.
15968499|NCT03123068|Other|Placebo|The placebo capsules will contain an inert ingredient packaged to be indistinguishable from the active treatment.
15968500|NCT03123055|Drug|B-701|B-701 (vofatamab) is a human IgG1 monoclonal antibody that is highly specific for the FGFR3 receptor.
15968501|NCT03123055|Drug|Pembrolizumab|Pembrolizumab is a humanized antibody used in cancer immunotherapy. Pembrolizumab targets and blocks a protein called PD-1 on the surface of certain immune cells called T-cells. Blocking PD-1 triggers the T-cells to find and kill cancer cells.
15968502|NCT03123042|Procedure|Sentinel basin dissection|Sentinel basin detection using endoscopic detector (Tc99m plus indocyanine green) injection and laparoscopic sentinel basin dissection. Then conventional gastrectomy
15968503|NCT03123029|Drug|Venetoclax|Venetoclax will be administered orally.
15968504|NCT03123016|Drug|Apremilast|Apremilast 30 mg orally, twice daily. (oral tablet)
15968505|NCT03123016|Procedure|NB-UVB phototherapy|treatment with narrowband UVB two to three times weekly to one half of their body for a total of 16 weeks
15968506|NCT03123003|Device|SonicBone Ultrasound|Bone age assessment by SonicBone Ultrasound. The patient needs to put his/her wrist in 3 positions.
15968507|NCT03123003|Device|Wrist X-ray|Bone age assessment by Wrist X-ray
15968508|NCT03122990|Procedure|FM-SRP|Supra- and sub-gingival mechanical instrumentation of the root surface of the whole dentition within 24 hours.
15968509|NCT03122990|Procedure|Q-SRP|"Supra- and sub-gingival mechanical instrumentation of the root surface will be performed in all dentition subdivided in four appointments. Each appointment will be performed in one week interval. In each appointment only a quadrant of the dentition will be instrumented.Performed in 3 weeks time frame."
15968510|NCT03122977|Procedure|FM-SRP|Supra- and sub-gingival mechanical instrumentation of the root surface of the whole dentition within 24 hours.
15968511|NCT03122977|Procedure|Q-SRP|"Supra- and sub-gingival mechanical instrumentation of the root surface will be performed in all dentition subdivided in four appointments. Each appointment will be performed in one week interval. In each appointment only a quadrant of the dentition will be instrumented."
15968512|NCT03122964|Diagnostic Test|AssureMDx|combined panel of methylation and mutation markers for the detection of bladder cancer
15968513|NCT03122951|Diagnostic Test|ovulation test use|Normal use of The Clearblue® Advanced Ovulation Test according to Information for use instructions
15968595|NCT03122314|Drug|Dexketoprofen|Second group: dexketoprofen 50 MG (Arveles ampoule -Ufsa- Istanbul) intravenous (IV) was given 100 patients
15968514|NCT03122938|Dietary Supplement|lactoferrin-supplemented formula|Subjects consume lactoferrin-supplemented formula (85mg lactoferrin per 100g) 3 times a day (81g totally).
15968515|NCT03122938|Dietary Supplement|formula without lactoferrin supplementation|Subjects consume formula without lactoferrin supplementation (<6mg lactoferrin per 100g formula) 3 times a day (81g totally).
15968516|NCT03122925|Device|MR|MR
15968517|NCT03122912|Dietary Supplement|Fish Oil|Capsules contain omega-3 fatty acids (fish oil). Dosage of 3180 mg of omega-3 fatty acids will be taken orally daily up to 16 weeks.
15968518|NCT03122912|Dietary Supplement|Soybean Oil|Dosage will be 3000 mg of soybean oil taken orally daily for up to 16 weeks.
15968519|NCT03122899|Device|SIJ fusion with iFuse-3D|Minimally invasive SIJ fusion with iFuse-3D titanium implant (usually 3 implants per SIJ).
15968520|NCT03122886|Dietary Supplement|Fat Emulsion|Given IV
15968521|NCT03122886|Other|Placebo|Given IV
15968522|NCT03122860|Drug|SM04690|Healthcare professional-administered intra-articular injection performed once on Day 1 of the study
15968523|NCT03122860|Other|Placebo|Healthcare professional-administered intra-articular injection performed once on Day 1 of the study
15968524|NCT03122860|Other|Sham|Healthcare professional-administered intra-articular injection performed once on Day 1 of the study
15968525|NCT03122847|Drug|Methylprednisolone|Intravenous methylprednisolone
15968526|NCT03122821|Other|Transcranial direct stimulation+Mental Imagery|"The subject will be practicing mental imagery along with mental imagery. A video of the task will be played in front of the patient and the subject will be asked to perform the mental practice of the activity.The video will be played thrice.The electrodes will be placed at the premotor cortex over the scalp corresponding to the topographical representation of upper limb on the contralateral cerebral hemisphere.Transcranial direct current stimulation (tDCS), (or Transcranial Micropolarization), is the most commonly used type of tCS [2, 19-25]. It employs a battery-driven stimulator to deliver weak direct currents (0.5-2.0 mA) through contact electrodes over the scalp. The current flow modulates neuronal excitability by altering the resting membrane potential of the neurons and produces aftereffects.Transcranial magnetic stimulation for 30 minutes, 5 days a week for 6 weeks.Transcranial direct stimulation for 30 minutes, 5 days a week for 6 weeks"
15968527|NCT03122821|Other|Transcranial magnetic stimulation|"The electrodes will be placed at the premotor cortex over the scalp corresponding to the topographical representation of upper limb on the contralateral cerebral hemisphere.Transcranial direct current stimulation (tDCS), (or Transcranial Micropolarization), is the most commonly used type of tCS [2, 19-25]. It employs a battery-driven stimulator to deliver weak direct currents (0.5-2.0 mA) through contact electrodes over the scalp. The current flow modulates neuronal excitability by altering the resting membrane potential of the neurons and produces aftereffects.Transcranial magnetic stimulation for 30 minutes, 5 days a week for 6 weeks.Transcranial direct stimulation for 30 minutes, 5 days a week for 6 weeks"
15968528|NCT03122808|Diagnostic Test|Uterine Activity Analysis|Analysis of components of uterine activity; contraction rate, length of contraction, length of relaxation and other values based off these measurements.
15968529|NCT03122808|Diagnostic Test|Partogram Analysis|Analysis of slope of partogram
15968530|NCT03122795|Procedure|Microbiome transplant|A raw microbiome, collected from a donor without any sinonasal health problems, as a nasal lavage.
15968531|NCT03122782|Drug|Topical application Tranexamic acid|Tranexamic acid (TXA) will be injected to distinction media during hysteroscopy in myomectomy
15968532|NCT03122782|Drug|Placebo (Normal saline)|5ml of normal saline will be added to every 500 ml of distension media
15968533|NCT03122769|Radiation|11C-metformin|200 MBq of 11C-metformin is injected in the cubital vein. The participant is then scanned for 120 min using Positron Emission Tomography
15968534|NCT03122756|Drug|Dexamethasone|Intravenous injection of dexamethasone 0.1 mg/kg maximum 8 mg (diluted with distilled water to 2 mL) just prior to administration of spinal anesthesia.
15968535|NCT03122756|Other|Normal Saline|Intravenous injection 2 mL intravenous normal saline (0.9 %) just prior to administration of spinal anesthesia.
15968536|NCT03122743|Procedure|Biospecimen Collection|Undergo collection of serum samples
15968537|NCT03122743|Other|Laboratory Biomarker Analysis|Correlative studies
15968538|NCT03122743|Other|Questionnaire Administration|Ancillary studies
15968539|NCT03122730|Combination Product|VentaProst|Part I - an equivalent dose of VentaProst compared to conventionally-administered aerosolized epoprostenol with subsequent dose titration to achieve a clinically significant hemodynamic response Part II - Dose titration to achieve a clinically significant hemodynamic response.
15968540|NCT03122717|Drug|Gefitinib|gefitinib is a EGFR inhibitor
15968541|NCT03122717|Drug|Osimertinib|An orally available, irreversible, third-generation, mutant-selective epidermal growth factor receptor (EGFR) inhibitor
15968542|NCT03122704|Procedure|GBS screening|Vaginal and anal swabs of patients will be screened for GBS screening
15968543|NCT03122691|Drug|cannabis|Cannabis will be self-administered by study participants
15968544|NCT03122678|Drug|Thiamine|
15968545|NCT03122678|Drug|Placebos|
15968546|NCT03122665|Drug|Nefopam Low dose|Continuous intravenous infusion at 0.5 mg/ml for three hours.
15968547|NCT03122665|Drug|Nefopam High dose|Continuous intravenous infusion at 1.0 mg/ml for three hours.
15968548|NCT03122652|Drug|Teriflunomide 14 MG Oral Tablet [Aubagio]|1 tablet once a day
15968549|NCT03122652|Drug|Placebo Oral Tablet|1 tablet once a day
15968550|NCT03122639|Drug|Atorvastatin 10mg|Atorvastatin 10 mg daily for 28 days will be randomly allocated to OSA patients regardless of adherence with CPAP. CPAP is a standard of care for OSA and will be prescribed by care providers not associated with this study based on clinical indications. The investigators will have no role in prescribing CPAP. Atorvastatin and placebo will be encapsulated to appear identical and dispensed by the research pharmacy.
15968551|NCT03122639|Drug|Placebo|Placebo daily for 28 days will be randomly allocated to OSA patients regardless of adherence with CPAP. CPAP is a standard of care for OSA and will be prescribed by care providers not associated with this study based on clinical indications. The investigators will have no role in prescribing CPAP. Atorvastatin and placebo will be encapsulated to appear identical and dispensed by the research pharmacy.
15968705|NCT03121638|Biological|ZOSTAVAX|Preparation of Oka/Merck strain of live, attenuated varicella zoster virus
15968552|NCT03122626|Behavioral|Together in Movement and Exercise (TIME) Program|The TIME program is an evidence-based, standardized, progressive, licensed exercise program developed by physical therapists at the Toronto Rehabilitation Institute-University Health Network.
15968553|NCT03122613|Dietary Supplement|Curcumin|3g of Curcumin per day
15968554|NCT03122613|Drug|Placebo|3g of Curcumin Placebo per day
15968555|NCT03122587|Device|Transcranial Alternating Current Stimulation at 10 Hz|Non-invasive, safe transcranial alternating current stimulation administered at 10 Hz to target alpha oscillatory activity
15968556|NCT03122587|Device|Transcranial Alternating Current Stimulation at 40 Hz|Non-invasive, safe transcranial alternating current stimulation administered at 40 Hz to target gamma oscillatory activity
15968557|NCT03122587|Device|Active sham transcranial alternating current stimulation|Active sham (placebo)
15968558|NCT03122574|Other|Lavender Aromatherapy|100% pure lavender aromatherapy was administered using person essential oil diffusor sachets, consisting of three drops of oil on a surgical sponge covered in a sealed plastic packet.
15968559|NCT03122574|Other|Jojoba Aromatherapy|100% pure jojoba aromatherapy was administered using person essential oil diffusor sachets, consisting of three drops of oil on a surgical sponge covered in a sealed plastic packet. This colorless, odorless oil was used as a placebo comparator.
15968560|NCT03122561|Drug|Paracetamol 500 mg tablet at morning|Single dose oral paracetamol will be administered at 8.00 am
15968561|NCT03122561|Drug|Paracetamol 500 mg tablet at midday|Single dose oral paracetamol will be administered at 2.00 pm
15968562|NCT03122561|Drug|Paracetamol 500 mg tablet at night|Single dose oral paracetamol will be administered at 8.00 pm
15968563|NCT03122548|Biological|CRS-207|Administered by IV infusion over 1 hour.
15968564|NCT03122548|Biological|Pembrolizumab|Administered by IV infusion over 30 minutes.
15968565|NCT03122535|Device|FS-LASIK 70 degree side-cut angle|FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.
15968566|NCT03122535|Device|FS-LASIK 110 degree side-cut angle|FS-LASIK surgical procedures will be performed according to the surgeons' standard practices. Patient will be masked as to the treatment they receive in either eye so as not to influence their subjective responses and visual measurements. Patients will be discontinued from the study if, on the day of surgery, both eyes cannot be randomized and operated as per protocol.
15968567|NCT03122522|Drug|ipilimumab|ipilimumab 3mg/kg
15968568|NCT03122522|Drug|nivolumab|nivolumab 1mg/kg
15968569|NCT03122509|Drug|durvalumab|1500 mg durvalumab via IV infusion
15968570|NCT03122509|Drug|tremelimumab|75 mg tremelimumab via IV infusion
15968571|NCT03122509|Radiation|Radiotherapy (RT)|Radiotherapy (RT) will be performed using external beam ionizing radiation as standard therapy in accordance with institutional standard practice.
15968572|NCT03122509|Procedure|ablation|Ablation will be performed percutaneously under image guidance as standard therapy at the discretion of the interventional radiologist in accordance with institutional standard practice.
15968573|NCT03122496|Drug|durvalumab|Patients will receive durvalumab (MEDI4736) and tremelimumab together every 4 weeks.
15968574|NCT03122496|Drug|tremelimumab|Patients will receive durvalumab (MEDI4736) and tremelimumab together every 4 weeks.
15968575|NCT03122496|Radiation|Stereotactic Body Radiotherapy (SBRT)|SBRT at 9Gy x 3 per standard of care given within 2 weeks after the completion of Cycle 1 of durvalumab (MEDI4736) and tremelimumab
15968576|NCT03122483|Diagnostic Test|blood biomarker|
15968577|NCT03122470|Device|MRI guided biopsy|The MRI guided biopsy will preferentially be performed using a 3 tesla (3T) Siemens Verio, or 3T Siemens Skyra machine. The multiparametric MRI exam will consist of T1-, T2- and diffusion weighted imaging with or without post-contrast perfusion studies. magnetic resonance fingerprinting (MRF) will be performed before contrast injection. The MRI will be interpreted by two specified radiologists from the research team.
15968578|NCT03122470|Procedure|TRUS biopsy|The TRUS biopsy will be performed per current standard of care. Biopsy cores will be sent to pathology in separately labeled specimen cups. The final pathological results will be compared with pre-biopsy MRI findings.
15968579|NCT03122457|Drug|lidamycin phosphate and benzoyl peroxide 1.2%/3.75% combination|At Day 15, patients will be re-assessed and dispensed the investigational product and instructed on its daily use. Patients will continue to return every 14 days to have their skin assessed until their final visit on day 99, one week after their 3rd menses on treatment (4th menses on study).
15968580|NCT03122444|Drug|Imipramine|Imipramine will be given daily for 21-30 days.
15968581|NCT03122431|Drug|Thalidomide|Thalidomide 100mg/day
15968582|NCT03122431|Drug|Hydroxychloroquine reduced|Hydroxychloroquine 400mg three times a week
15968583|NCT03122431|Drug|Hydroxychloroquine high|Hydroxychloroquine 800mg/day for three months
15968584|NCT03122418|Behavioral|Personal Fitness Device|Subjects will be given a personal fitness device to use to encourage exercise routinely. The impact this has on the individual perception of their quality of life will be the primary outcome for this study
15968585|NCT03122405|Device|RAM sensors|Noninvasive acoustic monitoring device
15968586|NCT03122392|Device|AMS 800|AMS 800 Artificial Urinary Sphincter
15968587|NCT03122366|Diagnostic Test|Detection of single nucleotide polymorphisms (SNP)|Asp299Gly SNP in the third exon of the TLR4 gene will be detected in blood
15968588|NCT03122353|Drug|Calcipotriene and betamethasone suspension|Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%
15968589|NCT03122353|Drug|Taclonex|Calcipotriene hydrate and betamethasone dipropionate topical suspension 0.005%/0.064%
15968590|NCT03122353|Drug|Placebo|vehicle used as placebo
15968591|NCT03122340|Drug|Ropren|Per os 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks
15968592|NCT03122340|Other|Oil|Per os 8 drops 3 times per day for 3 weeks, then 5 drops 3 times per day for 5 weeks
15968593|NCT03122327|Other|Questionaires|Questionaires of cGA assessment. No other interventions would be carried out aside from the standard treatment for MM.
15968594|NCT03122314|Drug|Paracetamol|1000 mg of paracetamol (perfalgan 10mg/ml solutionBristol-Myers Squibb_UK) intravenous (IV) was given 100patients
15968596|NCT03122301|Drug|Stellate Ganglion Block injection with bupivicaine|A computer-generated 1:1 block randomization scheme will be used to assign participants to receive either a SGB with bupivacaine or a sham injection with saline. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card.
15968597|NCT03122301|Drug|Saline|sham injection with saline
15968600|NCT03122275|Other|Customized text message invitation ( Step 1a)|Personalized text messages, automatically sent by Smart Message v.3.1 software. These text messages intend to invite women to cervical cancer screening
15968601|NCT03122275|Other|Customized automatic phone call invitation (Step 1b)|Personalized phone call, not operator dependent, automatically sent by Smart-Interactive Voice Response v.1.1 software These phone calls intend to invite women to cervical cancer screening
15968602|NCT03122275|Other|Secretary phone call (Step 2)|Manual phone call, performed by a trained secretary. These phone calls invite women to cervical cancer screening, but will only be used after automatic strategies (customized text messages and phone calls)
15968603|NCT03122275|Other|Health professional face-to-face appointment (Step 3)|"Women randomized to experimental arm, who do not undergo cervical cancer screening after automatic invitation or manual phone call, receive this intervention. First, women are contacted through a phone call, performed by a health professional, inviting them for a face-to-face appointment at her primary care unit.
~During appointments, the health professional understands possible barriers felt by women for not undergoing cervical cancer screening. Health professionals will try to overcome these barriers, using pre-defined arguments and facts. Finally, women are invited to perform screening."
15968604|NCT03122275|Other|Written Letter|"A written letter will be used to invite eligible women to cervical cancer screening.
~This intervention will be used only for women randomized to active comparator arm."
15968605|NCT03122262|Drug|Dolutegravir|DTG 50mg Oral Tablet once daily
15968606|NCT03122262|Drug|Tenofovir Alafenamide|TAF/FTC 25/200mg Oral Tablet once daily
15968607|NCT03122262|Drug|Truvada|
15968608|NCT03122262|Drug|Atripla|
15968609|NCT03122249|Behavioral|Advanced Cancer Symptom Management|For a period of eight weeks patients will use the OASIS web-application daily to help them get better control of their cancer symptoms. In addition, to daily symptom and strategy tracking, participants will have eight e-visits with the nurse-coach via the Zoom application through the UIHC eHealth and eNovation Center to evaluate their progress with managing their symptoms, assess for barriers to implementing strategies, and offering coaching on how to improve symptom management. Questionnaires and blood samples will be collected at baseline (week 0) and follow-up (weeks 4, 8, and 12).
15968610|NCT03122236|Behavioral|Neurorehabilitation of Standard Walking|Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of standard walking will focus on the use of typical steady state walking.
15968611|NCT03122236|Behavioral|Neurorehabilitation of Complex Walking|Neurorehabilitation is a behavioral therapeutic approach for enhancing the neural control of task performance by: Restoration of function, specificity of training, Sensory input to the nervous system, Intensity, Repetition and Progression of training. Neurorehabilitation of complex walking will focus on the use of walking tasks that require increased attention and executive functions. The following walking tasks will be used: over obstacles, navigating around obstacles, changing speeds, on soft surfaces (exercise mat), in dim lighting, while conversing with the therapist, up/down ramps and climbing/descending stairs.
15968612|NCT03122236|Device|Transcranial Direct Current Stimulation (tDCS) dosage A|"tDCS will be used to induce positive neuromodulation of frontal/executive circuits to make them more amenable to the activity-dependent neuroplasticity that is known to occur with behavioral neurorehabilitation. Specifically, tDCS may facilitate the efficacy of our walking neurorehabilitation intervention by strengthening the synaptic connections within the recruited circuits."
15968613|NCT03122236|Device|Transcranial Direct Current Stimulation (tDCS) dosage B|"tDCS will be used to induce positive neuromodulation of frontal/executive circuits to make them more amenable to the activity-dependent neuroplasticity that is known to occur with behavioral neurorehabilitation. Specifically, tDCS may facilitate the efficacy of our walking neurorehabilitation intervention by strengthening the synaptic connections within the recruited circuits."
15968614|NCT03122223|Biological|ALVAC-HIV (vCP2438)|expresses the gene products 96ZM651 gp120 (clade C strain) linked to the sequences encoding the HIV-1 transmembrane anchor (TM) sequence of gp41 (28 amino acids clade B LAI strain) and Gag and Pro (clade B LAI strain). It is formulated as a lyophilized vaccine for injection at a viral titer greater than or equal to 1 × 10^6 cell culture infectious dose (CCID)50 and less than 1 × 10^8 CCID50 (nominal dose of 10^7 CCID50) and is reconstituted with 1 mL of sterile sodium chloride solution (NaCl 0.4%), administered IM as a single 1 mL dose.
15968615|NCT03122223|Biological|Bivalent subtype C gp120/MF59|clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered IM as a single 0.5 mL dose.
15968616|NCT03122223|Biological|Bivalent subtype C gp120/AS01(B)|clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 20 mcg or 100 mcg, mixed with AS01B adjuvant, administered IM as a single 0.75 mL dose.
15968617|NCT03122223|Biological|Placebo|Sodium Chloride for Injection, 0.9%, administered IM.
15968618|NCT03122210|Device|Automated oxygen administration|In the control group, usual oxygen administration and titration is planned
15968619|NCT03122197|Drug|Letrozole Oral Tablet|Administration: Letrozole will be given orally once daily.
15968706|NCT03121638|Biological|NBP6081|Preparation of Oka/SK strain of live, attenuated varicella zoster virus
15968707|NCT03121638|Biological|NBP6082|Preparation of Oka/SK strain of live, attenuated varicella zoster virus
15968708|NCT03121638|Biological|NBP6083|Preparation of Oka/SK strain of live, attenuated varicella zoster virus
15968620|NCT03122184|Behavioral|Positive Psychology + Motivational Interviewing|For the positive psychology portion of the intervention, the study trainer will (a) review the week's positive psychology exercise, (b) discuss the rationale of the next week's positive psychology exercise through a guided review of the positive psychology manual, and (c) assign the next week's positive psychology exercise. For the motivational interviewing portion, participants will (a) review their physical activity goal from the prior week, (b) discuss techniques for improving physical activity, and (c) set a physical activity goal for the next week. Study trainers will use motivational interviewing techniques to facilitate goal setting.
15968621|NCT03122184|Behavioral|Motivational Interviewing Health Education|Each week, participants will learn about a different health behavior topic related to cardiac health. They will also be introduced to motivational interviewing topics in concert with the health behavior education topics. The intervention is divided into five sections, focusing on five different important cardiac health-related topics (recovery from an acute cardiac illness, physical activity, a heart-healthy diet, medication adherence, and stress reduction).
15968622|NCT03122171|Other|Occupational Therapy Treatment|Each occupational therapy treatment will be a one-hour standardized session that will include the following: stretching/strengthening (approximately 20 minutes), bi-manual training (approximately 20 minutes), and activities of daily living (approximately 20 minutes).
15968623|NCT03122158|Drug|Escitalopram|Escitalopram treatment will be given to the arms with a starting dose of 2.5 mg day. The treatment dose will be gradually increased up to 20 mg day (if necessary) and the maximal treatment dose was determined as 30 mg day in each group.
15968624|NCT03122145|Drug|Capsaicin|Participants will inspire deeply through the nebulizer coupled to the facemask and pneumotachograph. Each test inhalation will be separated by an interval of 2 minutes. This experimental trial consists of six (instead of 8) test solutions: 0, 25, 50, 100, 200 and 500 μM capsaicin in 80% physiological saline, 20% ethanol. Participants will inhale single vital capacity breaths of capsaicin solution via an air-powered dosimeter (KoKoDigidoser; Pulmonary Data Services Instrumentation Inc; Louisville, CO). The reflex cough test ends when the participant coughs at least 2 times in response to one inhalation dose, or receives a dose of the highest concentration (500 μM).
15968625|NCT03122145|Device|Videofluoroscopic swallow study|The swallowing systems core laboratory is fully equipped to perform videofluoroscopy with a c-arm (OEC 9900) that is dedicated solely to research purposes. Videofluoroscopy recordings will be kept to a minimum and turned on only during completion of a specific testing task. Video recording and images captured during the videofluoroscopy will be synced and saved for data analysis. Videofluoroscopy allows for time-synced, frame-by-frame data analysis for the specific measures taken during swallowing tasks. The physiological swallowing measures (temporal and kinematic of the base of tongue, oropharynx, and hyolarynx complex during swallowing) to be analyzed cannot be visualized with any other technique. All swallowing tasks will be completed using barium in order to visualize the bolus during movement of various swallowing muscles and structures.
15968626|NCT03122132|Drug|ombitasvir/paritaprevir/ritonavir 8 weeks|Spanish cohort with HCV treated in real practice with ombitasvir/paritaprevir/ ritonavir 8 weeks
15968627|NCT03122132|Drug|dasabuvir 8 weeks|Spanish cohort with HCV treated in real practice with dasabuvir 8 weeks
15968628|NCT03122119|Drug|Platelet Rich Plasma Joint Injection|30 to 50 milliliters of venous blood will be drawn from the patients arm with a 19 gauge ¾ inch needle using universal precautions. The venous blood will be mixed with 8 milliliters of anticoagulant citrate dextrose solution-A (ACD-A). The anti-coagulated blood will then be centrifuged for 15 minutes at 3200 revolutions per minute in the office centrifuge. This will allow plasma to separate from blood cells. The portion of centrifuged blood deficient in platelets will be extracted and discarded. Once the needle is visualized entering the joint capsule via ultrasound guidance and the physician feels resistance provided by the capsule and ligaments, 3 milliliters of PRP extract will be injected (3 inch, 22 gauge needle) into the sacroiliac joint. The needles will be properly disposed.
15968629|NCT03122106|Biological|Personalized neoantigen DNA vaccine|-Personalized polyepitope inserts integrating the prioritized neoantigens and mesothelin epitopes will be designed and then synthesized and cloned into the pING parent vector
15968630|NCT03122106|Device|TDS-IM Electrode Array System|-Ichor Medical Systems
15968631|NCT03122106|Procedure|Peripheral blood draws|-Enrollment, mid adjuvant chemotherapy, end of chemotherapy, week 1, week 5, week 9, week 13, week 17, week 21, week 25, and week 77
15968632|NCT03122080|Device|Electroacupuncture(EA)|"Participants in EA group will receive electroacupuncture treatment. Acupuncture will be applied at Baihui (GV20), Shenting (GV24), Yintang (GV29), bilateral Anmian (EX-HN22), Shenmen (HT7), SanYinjiao (SP6) and Neiguan (PC6). After needle insertion, rotating or lifting-thrusting manipulation will be applied for Deqi sensation. The EA apparatus (CMNS6-1, Jianjian Medical Device CO., LTD, China) will be connected to the needles at GV20 and GV29 for 30 minutes and deliver a continuous wave. The frequency will be set at about 30 Hz and the amplitude will be less than 20V. Participants can regularly take the antidepressants or sedative-hypnotics as before during the intervention. Besides, the investigators will strengthen health education about insomnia and depression for the patients."
15968633|NCT03122080|Device|Placebo acupuncture|Participants in the control A group will receive placebo acupuncture treatment with streitberger needles at the same acupoints as the electroacupuncture group. When the tip of the blunt needles touches to the skin, the patient will get a pricking sensation but there is no real needle inserted into the skin. The electroacupuncture apparatus will be set beside the patients, with no connection to the needles. Inform the patients when removing the needles after 30 minutes. Use the dry cotton ball to press the acupoints so that patients can feel the withdrawal of the 'needles'. Same health education and regular administration of antidepressants or sedative-hypnotics will be given to the participants during the intervention.
15968634|NCT03122080|Other|Standard care|Participants in the control B group will keep their standard medical care for the first 8 weeks. Participants will take their regular antidepressants and the sedative-hypnotics during the whole intervention period. Same health education will be conducted as well for the participants. And after waiting for two months, these patients will be treated with the same electroacupuncture treatment as the EA group.
15968635|NCT03122067|Drug|oxytocin treatment|intranasal administration of oxytocin
15968636|NCT03122067|Drug|placebo treatment|intranasal administration of placebo
15968747|NCT03121300|Other|CT Scan|Quantitative lung SPECT-CT
15968748|NCT03121300|Other|Lung CT|CT lung ventilation
15968749|NCT03121300|Other|MRI|DCE MRI
15968637|NCT03122054|Procedure|laparoscopic cholecystectomy|First trocar was inserted with Hasson method (Subumbilical 1 cm vertical incision was made and first 10-mm trocar (VersaportTM plus V2, Covidien, USA) inserted under direct vision) and pneumoperitoneum was created with 12 mm Hg pressure. Second 10-mm trocar was inserted from subxyphoid area. Two 5-mm trocars were inserted in the right upper quadrant area. After general intrabdominal exploration, dissection was started to ensure safe-view of Calot triangle. In case of quite tough gallbladder for griping, gallbladder was drained with a gray intravenous cannula. Cystic artery and cystic duct were separately dissected and twice ligated with Endo Clip™ II ML (Covidien, USA). Gallbladder was dissected from liver bed carefully. Gallbladder was taken out from abdomen through the subumbilical incision.
15968638|NCT03122041|Drug|Sitagliptin|
15968639|NCT03122041|Behavioral|Lifestyle intervention|
15968640|NCT03122028|Device|LAA closure system|Patients with non-valvular paroxymal, persistent or permanent atrial fibrillation with long-term sustainability and cannot be treated with anticoagulation and scheduled for interventional left atrial appendage closure.
15968641|NCT03122015|Other|Therapeutic clown distraction|The presence of the therapeutic clown, which can adapt his interventions of distraction to the state of health of the patient and the culture of the child, is a multimodal and multi sensorial distraction intervention and can have an impact on health status, procedures, family and multidisciplinary team members. The results of five studies evaluated the effects of distraction by the clown therapy demonstrate a decrease in pain and anxiety in children aged 2 to 17 years, as well as parental anxiety in painful procedures involving needles such as venipuncture.
15968642|NCT03122002|Drug|Drug Therapy|For this observation research, anti platelet drugs, statins and ect. would be used as clinical guidelines as usal, and statical ananysis of the relationship between these drugs and the final outcomes
15968643|NCT03122002|Diagnostic Test|Routine Blood Test and Image Scan|Routine blood test(HCY, LDL and ect.) and image scan (DWI, DSA and ect.)
15968644|NCT03122002|Other|Intravascular therapy|Intravascular therapy including thrombectomy
15968645|NCT03122002|Other|Emergency Treatment|Emergency treatment including time to self-diagnosis of stroke, time to call for help, devices used to hospital and ect.
15968646|NCT03122002|Other|Medical history|Medical history including hypertension, diabetes, hyperlipemia and ect.
15968647|NCT03121989|Drug|Hyperpolarized Pyruvate (13C) Injection|The new imaging method being tested in this study is called Metabolic MRI, which provides pictures of the metabolism occurring within cancer cells. It also involves injection of a contrast medicine, Hyperpolarized Pyruvate (13C) Injection, into the arm vein. The Participants in the active comparator arm will be injected with study drug Hyperpolarized Pyruvate (13C) Injection at a dose of 0.43/ml/kg.
15968648|NCT03121989|Other|Coil Testing|Participants will receive an MRI with a 1 cm diameter plastic ball that contains 13C-urea that will act as a test object. The test object provides a signal that will be used to ensure that the MRI system is functioning properly for participants in Group 2 . The plastic ball does not come in contact with you and there are no known risks associated with it.
15968649|NCT03121989|Drug|NAC|Participants will be receiving NAC as part of their clinical treatment.
15968650|NCT03121976|Device|Ultrasound|Femoral catheter inserted using ultrasound only
15968651|NCT03121976|Device|Ultrasound + Nerve Stimulation|Femoral catheter inserted using ultrasound and nerve stimulation
15968652|NCT03121963|Drug|Oxycodone|oxycodone tablet
15968653|NCT03121963|Drug|Acetaminophen|acetaminophen tablet
15968654|NCT03121963|Drug|Gabapentin|gabapentin tablet
15968655|NCT03121963|Drug|Celecoxib|celecoxib tablet
15968656|NCT03121963|Drug|Hydrocodone-Acetaminophen|hydrocodone 5 mg/acetaminophen 325 mg tablet
15968657|NCT03121950|Other|Dance|The primary intervention is a dance class
15968658|NCT03121950|Other|Music|the secondary intervention is listening to live music
15968659|NCT03121937|Behavioral|Mobile App|"The mobile app mConnect is an app designed to facilitate psychotherapy for depression and includes mood tracking, goal setting, and communication"
15968660|NCT03121924|Procedure|timing for oocyte denudation and Intracytoplasmatic Sperm injection|"Donated oocytes were randomly allocated to two groups concerning the time of cumulus corona removal.
~The first group: After oocyte retrieval, cumulus cells were immediately removed and then ICSI was performed; in the second group, the oocyte-cumulus complexes were incubated for 4 hours. Afterwards, the granulosa cells were removedand ICSI was immediately performed."
15968661|NCT03121911|Other|Interval Training (IT)|"Each exercise session will consist of:
~warm up (10 minutes)- stretches and calisthenics exercises of low to moderate intensity;
~interval training (IT) - 30 minutes of IT performed in a cycle ergometer, divided into 6 levels of intensity based on the ventilatory anaerobic threshold (VAT) found in CPET: Level 1 - 5 minutes in moderate intensity, at 80% of power reached in VAT; Levels 2 and 4 - 5 minutes of moderate to high intensity, at 100% of VAT; Levels 3 and 5 - 5 minutes of moderate to high intensity, 110% of VAT; Level 6 - 5 minutes in moderate intensity, at 70% of VAT.
~cooling down (10 minutes) - stretching, and breathing exercises. An CPET will be performed every four weeks to adjust the intensity of training."
15968662|NCT03121911|Other|Inspiratory Muscle Training (IMT)|"The IMT session will take place just after the warm-up exercises and consist of 2 series of 12 inspirations with a 60% of Maximal Inspiratory Pressure (MIP) with the equipment POWERbreathe Plus Medic® (POWERbreathe International Ltd, Warwickshire, UK). The patient will be instructed to remain seated with a nasal clip during the IMT series to avoid nasal air leakage and will be asked to inhale quickly and deeply, as quickly as possible, with a 2 minute interval between series. The training load will be adjusted weekly by a new evaluation of MIP to maintain the intensity of the exercise within the proposed value.
~All the others exercises will be identical between group 1 and 2."
15968663|NCT03121898|Device|Platelet function test|Measurement of P2Y12 and PAR-dependent platelet function activity before and after cardiac surgery by ADPtest and TRAPtest
15968664|NCT03121885|Behavioral|30-minute movement activity|The subjects arrive in the CRU after a 12 hours overnight fast to perform a 30-minute movement activity with individually adapted exercise intensity on the treadmill.
15968665|NCT03121885|Other|Hypoxia|The 30-minute movement activity on the treadmill will be completed by each subject once under normobaric normoxic and once under normobaric hypoxic conditions (equivalent to approximately 3000 meters above sea level) in a randomized episode.
15968750|NCT03121300|Other|Walk Test|6 minute hall walk test
15968751|NCT03121300|Other|SGRQ|St. George Respiratory Questionnaire
15968666|NCT03121872|Procedure|Root Coverage Surgery with T-PRF|Root surfaces in the multiple gingival recession regions were made smooth using Gracey curettes. To remove the smear layer, 24% EDTA solution was applied to the tooth surfaces for approximately 2 minutes and then washed with physiological saline. The receiver region was prepared using the modified tunnel method. After passive stabilization of the flap in the coronal aspect, the preparation of the donor region was initiated
15968667|NCT03121872|Procedure|Root Coverage Surgery with CTG|Root surfaces in the multiple gingival recession regions were made smooth using Gracey curettes. To remove the smear layer, 24% EDTA solution was applied to the tooth surfaces for approximately 2 minutes and then washed with physiological saline. The receiver region was prepared using the modified tunnel method. After passive stabilization of the flap in the coronal aspect, the preparation of the donor region was initiated
15968668|NCT03121859|Other|Neck stabilization exercise|Exercise
15968669|NCT03121859|Other|TENS|Transcutaneous electrical nerve stimulation (TENS)
15968670|NCT03121859|Other|IFC|Interferential current therapy(IFC)
15968671|NCT03121846|Drug|Apatinib|Apatinib 500 mg is administered orally daily, until disease progression or untolerable toxicity.
15968672|NCT03121833|Drug|Endostar|Recombinant Human Endostatin Injection
15968673|NCT03121833|Drug|Placebo|500ml 0.9% sodium chloride
15968674|NCT03121833|Drug|AIM regimen / GT regimen|"Pirarubicin (THP) + Ifosfamide (IFO) / Docetaxel (TXT) + Gemcitabine (GEM)"
15968675|NCT03121820|Drug|Memantinol tablets, 20 mg|"Bioequivalence Memantine Hydrochloride (JSC GEROPHARM, Russia) 20 mg film-coated tablets fasting condition"
15968676|NCT03121820|Drug|Akatinol Memantine® tablets, 20 mg|Bioequivalence Memantine Hydrochloride (Merz Pharma GmbH & Co. KGaA, Germany) 20 mg film-coated tablets fasting condition
15968677|NCT03121807|Other|Oliclinomel N4 Per bag 1.5 L|Home parenteral nutrition with 910 kcal/day , including 33 g amino acid/day, 120 g glucose/day, 30 g lipid/day and electrolyte, micro-element and vitamin according to the nutritional status of subjects and followed the standard procedure of the hospital (Oliclinomel N4 Per bag 1.5 L), was infused continuously daily in an infusion time ranged between 18-24 hours.
15968678|NCT03121807|Drug|Oxaliplatin|
15968679|NCT03121807|Drug|5Fluorouracil|
15968680|NCT03121807|Drug|Leucovorin|
15968681|NCT03121794|Procedure|Ultrasonographic exam|The study team will perform an ultrasonographic exam of the proximal humerus to identify six anatomical landmarks
15968682|NCT03121794|Device|ultrasound machine|Regular ultrasound machine used at Cleveland Clinic
15968683|NCT03121781|Other|respiratory support- interface|change interface to RAM cannula
15968684|NCT03121781|Other|respiratory support- interface|change interface to binasal prongs
15968685|NCT03121742|Behavioral|Ecological Momentary Intervention|Patients will be taught four therapeutic intervention skills based on positive psychology and cognitive behavioral therapy. They will then be prompted to complete these interventions on a smartphone four times per day (and as needed) for the duration of their inpatient care and for 28 days afterwards.
15968686|NCT03121742|Behavioral|Treatment as Usual|Standard care as part of inpatient hospitalization.
15968687|NCT03121729|Procedure|enhanced recovery after surgery|Undergo an enhanced recovery after surgery program
15968688|NCT03121716|Biological|SHR-1210|SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody.
15968689|NCT03121716|Drug|Gemcitabine|gemcitabine
15968690|NCT03121716|Drug|cis-platinum|cis-platinum
15968691|NCT03121703|Other|lumbar stabilization exercise|lumbar stabilization exercise
15968692|NCT03121703|Other|trunk muscle strengthening exercise|trunk muscle strengthening exercise
15968693|NCT03121690|Drug|Prednisone|prednisone 40 mg/day for 7 days
15968694|NCT03121690|Drug|placebo|5ml saline / day for 7 days
15968695|NCT03121677|Biological|Personalized tumor vaccine|"Cycle 12 vaccine administration is optional
~The peptides comprising the vaccine are reconstituted in up to 4 pools with 5 peptides per pool (A, B, C, and D) . At each vaccination time point, each of the up to four pools will be administered to one of the four limbs (A - Right Arm, B - Left Arm, C - Right Leg, D - Left Leg) by subcutaneous injection."
15968696|NCT03121677|Drug|Poly ICLC|-The personalized tumor vaccine will be co-administered with poly-ICLC.
15968697|NCT03121677|Biological|Nivolumab|-Nivolumab will be administered at a dose of 240 mg intravenously
15968698|NCT03121677|Procedure|Peripheral blood draws|-Time of biopsy, during the pre-treatment check (any time before cycle 1 day 1), Cycle 1 Day 15, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 6 Day 1, Cycle 12 Day 1, Time of response, and Time of progression or relapse
15968699|NCT03121677|Procedure|Leukapheresis|"Prior to the initiation of treatment and up to five days prior to treatment on cycle 6 day 1, patients will undergo apheresis according to standard institutional procedures for non-mobilized collection.
~Peripheral blood leukocytes will be cryopreserved for later assessment for the presence of T-cells that recognize tumor specific mutant antigens and immunophenotype, and the presence of other lymphocytes or regulatory populations."
15968700|NCT03121677|Biological|Rituximab|-Other anti-CD20 mAb treatment can be used
15968701|NCT03121677|Procedure|Biopsy|-Biopsies on lymph node or extranodal site(s) are to be obtained at: screening (only after the patient is deemed eligible; during cycle 2 (after treatment on C2D15 and prior to treatment on C3D1); disease relapse or progression (if this occurs)
15968702|NCT03121664|Drug|PF06649751, Itraconazole|PF-06649751 0.25 mg on Days 1,2,3 PF-06649751 0.5 mg on Days 4,5,6 PF-06649751 1 mg on Days 7 to Day 25 Itracoanzole 200 mg on Days 12 to Day 25
15968703|NCT03121651|Device|RL-adaptive application|"Up to 6 dyads of individuals with disabilities and their caregivers will be recruited to collaborate in defining the features and content of the RL-adaptive support. The steps in developing the RL-adaptive support include having the dyads use for approximately 6 weeks each:
~young adult uses an electronic medication pillbox that sends its pillbox openings within one hour of opening to the research team,
~young adult uses the electronic medication pillbox + both use a commercially available medication reminder app + caregiver uses a pillbox opening notification app, and
~young adult uses the electronic medication pillbox + the RL-adaptive support including push notifications in the form of text messages + caregiver uses the pillbox opening notification app.
~The goal is to reduce the number of caregiver prompts necessary for the medication pillbox to be opened."
15968704|NCT03121638|Biological|VARIVAX|Preparation of Oka/Merck strain of live, attenuated varicella zoster virus
15968709|NCT03121625|Biological|Autologous CAR-T|Patients will be drawn 50-100 ml blood to obtain enough peripheral blood mononuclear cells (PBMC) for CAR-T manufacturing. The T cells will be purified from the PBMC, transduced with CAR lentiviral vector, expanded in vitro and then frozen for future administration. Chemotherapy will then be given. Following tumor burden reassessment, CAR-T cells will be infused.
15968710|NCT03121612|Device|CPAP|CPAP therapy
15968711|NCT03121599|Device|Diagnostic (18F-FLT PET/CT)|The tracer compound [F-18] FLT will be injected into the patient's veins in a small volume of normal saline solution. The PET scan data collection is started immediately and is continued for 2 hours.
15968712|NCT03121586|Drug|Pimavanserin|Pimavanserin 10 mg, tablet, taken as one 10 mg tablets, once daily by mouth, OR Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth, OR Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth
15968713|NCT03121573|Drug|Duloxetine|duloxetine 30 to 60 mg tablets by mouth, QD to BID per day,
15968714|NCT03121560|Device|Hysteroscopy|Hysteroscopy allows a direct visualization of the interior of the uterine cavity in order to invalidate or confirm the presence of uterine pathologies.In the pre-menopausal period, it is preferable to perform a hysteroscopy at the beginning of the follicular phase (just after the menstruations, when the endometrium is atrophic). Use of a rigid hysteroscope comprising a 2.9 mm optics and a 4.3 mm sheath with a 5 - bit operator channel allowing the realization of a biopsy.
15968715|NCT03121560|Device|Hysterosonography|Hysterosonography (SIS) is an endovaginal ultrasound performed along with an injection of saline in order to observe the uterine cavity and detect any endometrial pathology. A 3D image can be associated with it to define the topography of a lesion. It is ideally performed in the first part of the cycle. Use of the GE Voluson E8 Ultrasound System.
15968716|NCT03121547|Drug|Tapentadol 50 mg Oral Tablet|1 tablet administered
15968717|NCT03121547|Drug|Tramadol Hydrochloride 100 mg Extended Release Oral Tablet|1 tablet administered
15968718|NCT03121547|Drug|Placebo Oral Tablet|calcium tablet
15968719|NCT03121534|Drug|Blinatumomab|"Induction phase consists of a single cycle of Blinatumomab therapy. Blinatumomab initiated at 9 mcg/day from day 1-7, followed by 28 mcg/day from day 8-14 (week 2). This is followed by 112 mcg/day from day 15-56. The induction cycle is 8 weeks in duration.
~Patients who achieve an objective response after induction are eligible to receive one further cycle of Blinatumomab consolidation, delivered at 112 mcg/day by continuous vein infusion from day 1-28 (total of 4 weeks). Consolidation may be initiated 4-8 weeks after completion of the induction infusion of Blinatumomab."
15968720|NCT03121534|Drug|Dexamethasone|Dexamethasone 20 mg by mouth or vein 24 hours prior to and within 1 hour before start of treatment in each treatment cycle. If treatment is interrupted for >4 hours at any point, Dexamethasone treatment given before re-initiation of therapy. Dexamethasone 8 mg by mouth or vein every 8 hours given for 48 hours at the commencement of the infusion and after each dose increment.
15968721|NCT03121521|Drug|Melatonin 10 mg|melatonin 10mg daily p.o.
15968722|NCT03121521|Drug|Placebo|Placebo 10mg daily p.o.
15968723|NCT03121508|Behavioral|Taking on Diabetes to Advance You (TODAY) Project|This is an individualized educational intervention with activity components designed to assist in modifying habits, roles, and routines to promote healthy lifestyle patterns for individuals with type 2 diabetes.
15968724|NCT03121495|Diagnostic Test|Second forward view (SFV) examination of the right colon|The colonoscope will be advanced to the cecum again when hepatic flexure was reached the first time, where a second forward view (SFV) examination of the right colon will be performed
15968725|NCT03121482|Device|HFNC|Gas flow of 50 l/min and FiO2 adjusted to obtain SpO2 ≥ 92%
15968726|NCT03121482|Device|NIV|Pressure-support level to achieve an expired tidal volume between 6 and 8 ml/kg and PEEP level of 5 cm H2O with FiO2 adjusted to obtain SpO2 ≥ 92%
15968727|NCT03121469|Device|Papillon +TM|Technique of Per-Operative Radiotherapy (RPO) by Papillon +TM
15968728|NCT03121456|Other|18F-FDG PET SCAN|REALIZATION OF INITIAL 18F-FDG PET SCAN (PRE THERAPEUTIC), THEN BETWEEN CYCLE 2 DAY 10 AND CYCLE 3 DAY 1
15968729|NCT03121456|Other|MRI DIFFUSION|REALIZATION OF INITIAL MRI DIFFUSION WITHIN 7 DAYS AFTER INITIAL 18F-FDG PET SCAN, THEN WITHIN 7 DAYS AFTER 18F-FDG PET SCAN 1.
15968730|NCT03121443|Other|Perfusion index|supine,prone, trendelenburg,reverse trendelenburg,45 degrees back up sitting position, 45 degrees legs lifted supine position.
15968731|NCT03121430|Device|Drug eluting peripheral vascular stent system|Drug eluting peripheral vascular stent system、Color Doppler Ultrasonography (CDU) imaging、Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）
15968732|NCT03121430|Device|Nitinol Stent System|Nitinol Stent System、Color Doppler Ultrasonography (CDU) imaging and Dual Fluoroscopic Imaging、Digital subtraction angiography（DSA）
15968733|NCT03121417|Biological|Nivolumab|240 mg given IV
15968734|NCT03121404|Procedure|Rectus abdominis muscle biopsy|Patients who will already be having either liver transplant surgery or abdominal surgery will have a biopsy of their rectus abdominis muscle during the time of surgery.
15968735|NCT03121391|Procedure|Ventilator withdrawal algorithm|"Steps and decision trees in the algorithm include in descending order:
~Ascertain patient consciousness, perform cuff-leak test, evaluate for indications for pre-medication, select a withdrawal method, assess for respiratory distress with Respiratory Distress Observation Scale, medicate for respiratory distress with morphine, make an extubation decision, ascertain need for continuous morphine, ascertain need for supplemental oxygen, assess for post-extubation stridor, treat post-extubation stridor"
15968736|NCT03121378|Other|Blood sample 1|Blood taken before prosthesis implantation
15968737|NCT03121378|Other|Blood sample 2|Blood taken after prosthesis implantation
15968738|NCT03121365|Behavioral|Digital/E-Book Arm|Promotion of early reader digital e-book reading
15968739|NCT03121365|Behavioral|Standard/Board Book Arm|Promotion of early reader board book reading
15968740|NCT03121352|Drug|Carboplatin|AUC 4.5 IV day 1 of 21-day cycle
15968741|NCT03121352|Drug|Nab-paclitaxel|75mg/m2 IV days 1, 8 and 15 of 21-day cycle
15968742|NCT03121352|Drug|Pembrolizumab|200 mg IV every 21 days
15968743|NCT03121339|Biological|VXA-A1.1 H1 Tablet Vaccine (small)|Tableted oral H1 vaccine (~140 mg tablet)
15968744|NCT03121339|Biological|VXA-A1.1 H1 Tablet Vaccine (large)|Tableted oral H1 vaccine (~275 mg tablet)
15968745|NCT03121326|Diagnostic Test|blood and urine sampling|Ten mL blood and 15mL urine are collected.
15968746|NCT03121313|Drug|tegafur-uracil|
15968756|NCT03121287|Other|Pulmonary|Pulmonary Function Tests & 6 minute hall walk
15968757|NCT03121287|Other|Imaging|Cardiac MRI
15968758|NCT03121287|Other|Specimen Collection|Blood draw
15968759|NCT03121274|Procedure|vaginal delivery|vaginal delivery is carried by an expert obstetrician and the need for forceps or ventose is recorded
15968760|NCT03121261|Drug|levobupivacaine|Comparing: 0.5% levobupivacaine 15 milligrams (mg) , 0.015% clonidine 50 micrograms (mcg) and 40% glucose 0.5 milliliters (ml) with 0.5 levobupivacaine 15 mg , 0.9% saline 0.33 ml and 40% glucose 0.5 ml
15968761|NCT03121261|Drug|clonidine|Comparing: 0.5% levobupivacaine 15 mg , 0.015% clonidine 50 mcg and 40% glucose 0.5 ml with 0.5 levobupivacaine 15 mg , 0.9% saline 0.33 ml and 40% glucose 0.5 ml
15968762|NCT03121248|Radiation|WBI 5 fractions|External beam radiotherapy in 5 fractions of 5,7Gy
15968763|NCT03121248|Radiation|WBI 15 fractions|External beam radiotherapy in 15 fractions of 2,67Gy
15968764|NCT03121248|Radiation|LNI 5 fractions|External beam radiotherapy in 5 fractions of 5,4Gy
15968765|NCT03121248|Radiation|LNI 15 fractions|External beam radiotherapy in 15 fractions of 2,67Gy
15968766|NCT03121248|Radiation|SIB 5 fractions if needed|Simultaneous boost of 5 x 6,2Gy (6,5Gy in case of involved resection margins) if needed
15968767|NCT03121248|Radiation|SIB 15 fractions if needed|Simultaneous boost of 15x3,12Gy (3,33Gy in case of involved resection margins) if needed
15968768|NCT03121248|Radiation|TWI 5 fractions|External beam radiotherapy in 5 fractions of 5,7Gy
15968769|NCT03121248|Radiation|TWI 15 fractions|External beam radiotherapy in 15 fractions of 2,67Gy
15968770|NCT03121235|Diagnostic Test|PCR based detection of azole resistance in A. fumigatus|Diagnosis and treatment of IA will be based on the results of a standardized diagnosis and treatment protocol that includes the use of the AsperGenius® PCR.
15968771|NCT03121222|Drug|N-acetylcysteine|The antioxidant group received orally two N-acetylcysteine tablets (each tablet contained 600 mg of NAC; Lamberts Health Care Ltd, Kent, United Kingdom). The participants were instructed to receive the capsules every twelve hours in order to achieve high concentration of N-acetylcysteine throughout the 24 h. Each individual received the capsules pre-packed in daily doses labeled with the day of consumption. The supplementation period was 30-day for N-acetylcysteine.
15968772|NCT03121222|Drug|Lactose|The placebo group received orally two lactose tablets per day. The participants were instructed to receive the capsules every twelve hours. Each individual received the capsules pre-packed in daily doses labeled with the day of consumption. The supplementation period was 30-day for placebo.
15968773|NCT03121196|Other|Epices score|Association between EPICES score and the adverse perinatal outcomes will be assessed by quantile regression
15968774|NCT03121183|Device|Laser sheath|Patients who have undergone an extraction of implantable pacemaker or defibrillator leads whatever the indication for the period march 2015-2017
15968775|NCT03121183|Behavioral|Implantable Cardiac Device lead extraction|Patients who have undergone an extraction of implantable pacemaker or defibrillator leads whatever the indication for the period march 2015-2017
15968776|NCT03121170|Other|extracorporeal shock wave therapy|Intervention group is by extracorporeal shock wave therapy.A radial shock wave device (EMS Swiss Dolor, Munich, Germany) was used. Radial shock wave is created ballistically with the pressurized air source accelerating a bullet to strike a metal applicator. The kinetic energy produced is transformed into radially expanding shock waves from the application site into the tissue to be treated. The treatment of area is lower abdomen which has some acupuncture points such as Shenque(CV8) ,Qihai(BL24), Guanyuan(CV4), Zhongji(CV3), Tianshu(ST25), Guilai(ST29) and Zigong(EX-CA1) at the right and left sides of the lower abdomen. All acupuncture points should be placed according to participants' feedback during treatment.
15968777|NCT03121170|Other|hot compress paste|Hot compress pastes will be sticked on the lower abdomen.
15968778|NCT03121157|Behavioral|Multi-Component Technology Based Intervention|The intervention group receives two sessions of computer-delivered MI via software programmed to target adherence to medications and text messaged adherence reminders between sessions. Sessions are provided by an avatar. The intervention engages the youth with the avatar's communication of empathy, optimism, and autonomy support. The intervention focuses the youth on adherence and relevant health behaviors with feedback on adherence, asthma symptoms, and tailored education. Participants are guided in the planning process through goal setting activities. The length of the intervention sessions are about 30 minutes each, with the total duration of the visit (assessment and intervention) lasting about 1.5 hours.
15968779|NCT03121144|Device|Masimo Centroid System|Noninvasive positional monitoring device
15968780|NCT03121131|Other|Clinical Exam Findings|Findings found on clinical exam of a patient the radiologist will be reading CT scans of.
15968781|NCT03121131|Other|Inaccurate Clinical Exam Findings|Inaccurate findings are given to the radiologists
15968782|NCT03121131|Other|No clinical exam findings|No clinical exam findings are given to the radiologists
15968783|NCT03121118|Other|Scan Opportunity|Participants in the scan group are provided the option of having an amyloid PET brain scan and receiving their results which can inform them of risk for developing Alzheimer's Disease.
15968784|NCT03121092|Drug|ACEI or ARB|Angiotensin converting enzyme inhibitors (ACEI's) and Angiotensin receptor blockers (ARB's) - commonly used anti-hypertensive medications
15968785|NCT03121079|Drug|Interferon-alpha|patients in Interferon-alpha group will receive Interferon-alpha injection since the third month after transplantation for six months.
15968786|NCT03121066|Device|Active Transcranial Magnetic Stimulation|The intervention consists of a 2-week treatment during which TMS will be applied for 10 days (every working day). The stimulation protocol will be intermittent TBS (iTBS). 600 pulses in each area will be applied at intervals of 2 seconds of stimulation and 8 seconds of rest; the total number of pulses per session will be 1200. The stimulation duration is 3 minutes and 12 seconds. This protocol allows the induction of long-term potentiation effects, promoting plasticity in the stimulated areas. To perform the stimulation a 70 mm, figure of 8-coil will be used. In order to precisely locate the stimulated areas a stereotactic image guidance will be used during the stimulation (Brainsight™ 2)
15968787|NCT03121066|Device|Sham Transcranial Magnetic Stimulation|The Sham intervention will be carried out using the same stimulation protocol as in the active condition but with the coil rotated 90º to prevent the magnetic field inducing electrical activity in the cortex.
15968788|NCT03121053|Drug|sodium bicarbonate|
15968789|NCT03121053|Drug|hypotone saline|
15968790|NCT03121040|Dietary Supplement|Vespa amino acid mixture|17 kinds of amino acids mixture in specific proportion
15968791|NCT03121014|Drug|Fludarabine|40 mg/m^2 IVBP daily for day -5 (5 days before stem cell infusion) through Day -2
15968792|NCT03121014|Drug|Busulfan|targeting a 4800μM/min/ day from day -5 through day -2
15968793|NCT03121014|Drug|ATG|0.5 mg/kg IV on day -3, and 2 mg/kg on days -2 and day -1
15968794|NCT03121014|Radiation|Total Marrow Irradiation|dose of 3Gy on days -3, -2 and -1
15968795|NCT03121014|Procedure|Stem Cell Product Infusion|Day 0 according to BMT unit policy
15968796|NCT03121014|Drug|Tacrolimus|The starting dose is at 0.03 mg/kg/day IV continuous infusion over 24 hr from 4 PM on day -2. Dose will be adjusted to target trough levels of 5-15 ng/mL. More information is available in the protocol document.
15968797|NCT03121014|Drug|Methotrexate|5mg/m^2 on Day 1, 5 mg/m^2 on Days 3, 6 and 11
15968805|NCT03120988|Biological|Lavage with Platelet Poor Plasma (PPP)|Lavage of 50cc PPP
15968806|NCT03120975|Other|Computerized decision support and audit & feedback|"suggestion of guideline concordant antimicrobial treatment based on indication entry in the computerized physician order entry system
~mandatory reevaluation of antimicrobial therapy therapy on calendar day 4 of treatment
~suggestion of standard antimicrobial treatment duration according to indication"
15968807|NCT03120975|Other|Audit & Feedback|* regular (at least monthly) feedback of antibiotic use quality indicators (on the ward level)
15968808|NCT03120975|Other|Standard antibiotic stewardship|"Infectious diseases consultation on demand
~Review of positive blood cultures
~Availability of a antibiotic use guidelines (on paper and as PDF)"
15968809|NCT03120962|Drug|Oxycodone|Oxycodone 20mg/day, for 4 weeks
15968810|NCT03120962|Drug|Gabapentin|Gabapentin 900mg/day, titrated up to max tolerated dose or 1800mg/day, for 4-12 weeks
15968811|NCT03120962|Drug|Famciclovir|Famciclovir 500mg three-times daily for 7 days
15968815|NCT03120936|Drug|Emtricitabine / Tenofovir Disoproxil Oral Tablet|Open-label emtricitabine 200mg/tenofovir 300mg
15968816|NCT03120936|Behavioral|PrEP support|HIV/STI testing and counseling, adherence counseling, medical exams, safety monitoring, short message system (SMS), ie text message, and peer support, panel management.
15968817|NCT03120923|Drug|Lidocaine 3 cc|
15968818|NCT03120923|Drug|Lidocaine 9 cc|9mL of 1% lidocaine plus 1mL of 40mg triamcinolone acetonide
15968819|NCT03120923|Drug|Triamcinolone Acetonide|
15968820|NCT03120910|Device|Pulse CO-Oximeter Sensor|Investigational Pulse Oximeter Sensor will measure hemoglobin (SpHb), pulse rate (PR), perfusion index (PI), pleth variability index (PVI), oxygen reserve index (ORI), etc.
15968821|NCT03120897|Device|RAM sensor|Rainbow Acoustic Monitoring sensor for measurement of respiratory rate
15968822|NCT03120884|Procedure|ICSI|A technique that involves microinjection of spermatozoa into mature oocytes.
15968823|NCT03120884|Procedure|IVF|A process of fertilisation where an an egg is combined with sperm outside the body, in vitro.
15968824|NCT03120858|Behavioral|Determine what the imagery levels are|Determine the motor imagery: kinesthetic and visual imagery
15968825|NCT03120845|Procedure|One visit RCT|Root canal treatment in one vist
15968826|NCT03120845|Procedure|Post operative pain in two-visits RCT|Root canal treatment in Two visits
15968827|NCT03120832|Biological|PAN-301-1|
15968828|NCT03120819|Behavioral|Oncologist Recommendation|Patients in this arm receive a 2-3 minute verbal recommendation about exercise from their treating oncologist
15968829|NCT03120819|Behavioral|Oncologist Recommendation + DVD|Patients in this arm receive a 2-3 minute verbal recommendation about exercise from their treating oncologist and then be sent an instructional exercise DVD to follow at their home three times per week for eight weeks
15968830|NCT03120806|Procedure|Interrupted subcuticular skin closure|skin is closed with interrupted mattress subcuticular sutures using non-absorbable polypropylene after elective cesarean section
15968831|NCT03120806|Procedure|continuous subcuticular skin closure|skin is closed with continuous subcuticular sutures using non-absorbable polypropylene after elective cesarean section
15968832|NCT03120793|Device|Esophageal balloon catheter|Measurements obtained from mechanically ventilated patients with ARDS in the supine, upright and prone positions
15968833|NCT03120780|Drug|Fentanyl 20 mcg|20 mcg fentanyl in 10 mL 0.125% bupivacaine
15968834|NCT03120780|Drug|Fentanyl 100 mcg|100 mcg fentanyl in 10 mL 0.125% bupivacaine
15968835|NCT03120767|Behavioral|Risk and Resilience|"The Risk and Resilience course is a 14-week undergraduate seminar that is grounded in the current understanding of adolescent and young adult development, neuroscience, and positive psychology. Students will learn about key areas proven to enhance wellness, including communication, executive functioning, social support, self-efficacy, emotion regulation, and sense of purpose. Students will learn about healthy exercise, nutrition, and sleep habits, and develop skills in core components of cognitive-behavior therapy, mindfulness, and organizational skills."
15968836|NCT03120767|Behavioral|Coordinated Wellness Programming|"During the Fall of 2017, wellness activities will be provided within Founders Hall that support the theories and skills being taught in the Risk and Resilience course occurring in the same semester."
15968837|NCT03120754|Procedure|Place the peritoneal drainage|In the experimental group, the abdominal drainage was not placed
15968838|NCT03120754|Procedure|No peritoneal drainage|Intraoperative placement of peritoneal drainage as control group.
15968839|NCT03120728|Drug|Etonogestrel/ethinyl estradiol contraceptive vaginal ring|"Placement of a contraceptive vaginal ring with subsequent assessment of ovulation disruption. Timing of placement depends on leading follicle size, as described in Arms section."
15968840|NCT03120715|Drug|estrogen|The oral estrogen replacement is 4mg per day (2 mg twice daily), 4 days; 6 mg per day, 4 days. Then, the patient's endometrial thickness is evaluated through vaginal ultrasound and if the endometrial thickness is <7 mm, increasing estrogen by 2 mg is given to patients until the endometrial thickness is >9 mm.
15968841|NCT03120715|Drug|Low Molecular Weight Heparin|If the endometrial thickness is greater than 9 mm, hCG 10000 IU will be administered via intramuscular injection.And low molecular weight heparin (LMWH) will be injected subcutaneously 4100 IU (WHO) every other day before FET.Then on the next day(D0), progesterone in oil 60 mg will be administered via intramuscular injection. Transfer of thawed embryos will be performed 3 days later(D3).
15968842|NCT03120715|Drug|hCG|If the endometrial thickness is greater than 9 mm, Human Chorionic Gonadotropin（hCG） 10000 IU will be administered via intramuscular injection.
15968843|NCT03120715|Drug|progesterone|on the next day(D0), progesterone in oil 60 mg will be administered via intramuscular injection. Transfer of thawed embryos will be performed 3 days later(D3).
15968844|NCT03120702|Device|Investigational Rainbow SpHb sensor|Investigational Rainbow SpHb sensor
15968845|NCT03120689|Other|Live Surgery using VITOM|The vaginal operative field will be filmed with a VITOM® camera and the image from the VITOM® camera will be projected live within the operating room, so that the operating team can reference the image during the surgery.
15968846|NCT03120689|Other|Live Surgery without VITOM|The vaginal operation will not be filmed and learner observation will take place in the traditional way, with them looking at the physical surgical field.
15968847|NCT03120689|Other|Video viewing with VITOM|They will view the 10-minute standardized video filmed with the VITOM® camera.
15968848|NCT03120689|Other|Video viewing with standard handheld high-definition camera|They will view the 10-minute standardized video filmed with the standard, handheld high-definition camera.
15968849|NCT03120676|Drug|Atezolizumab|All patients will receive atezolizumab 1200 mg via IV infusion on D1 of each 21-day cycle.
15968850|NCT03120663|Drug|amoxicillin-clavulanic acid|"During one dosing interval at steady state of the involved antimicrobials (ABs), AB plasma concentrations will be determined.
~Besides, the measured creatinine clearance based on an 8-hour urinary collection (CrCl8h) will be used as the primary method for determining kidney function. Based on these values, CrCl8h will be calculated according to the standard formula and normalized to a body surface area (BSA) of 1.73m² ."
15968851|NCT03120650|Other|Scalp acupuncture|Acupoint selection: Shenting (DU24; Baihui (DU20; and upper 1/5 and middle 2/5 in the contralateral motor area (upper: 0.5 cm posterior to the midpoint of the front and rear midline; middle 2/5: intersection between the eyebrow line and the leading edge of the temple hairline.
15968852|NCT03120650|Other|Conventional rehabilitation|Rehabilitation plans will be made according to the Guidelines for Stroke Rehabilitation in China (Cerebrovascular Disease Association and the Neurological Rehabilitation Association of Neurology Branch of the Chinese Medical Association, 2012), including physical therapy and occupational therapy.
15968853|NCT03120637|Drug|Methylene Blue|
15968854|NCT03120624|Procedure|Biopsy|Undergo image-guided biopsy
15968855|NCT03120624|Procedure|Computed Tomography|Undergo SPECT/CT
15968856|NCT03120624|Other|Fluorine F 18 Tetrafluoroborate|Given IV
15968857|NCT03120624|Other|Laboratory Biomarker Analysis|Correlative studies
15968858|NCT03120624|Other|Pharmacological Study|Correlative studies
15968859|NCT03120624|Procedure|Planar Imaging|Undergo whole body planar imaging
15968860|NCT03120624|Procedure|Positron Emission Tomography|Undergo TFB-PET
15968861|NCT03120624|Biological|Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter|Given IV
15968862|NCT03120624|Drug|Ruxolitinib|Given PO
15968863|NCT03120624|Drug|Ruxolitinib Phosphate|Given PO
15968864|NCT03120624|Procedure|Single Photon Emission Computed Tomography|Undergo SPECT/CT
15968865|NCT03120624|Drug|Technetium Tc-99m Sodium Pertechnetate|Given IV
15968866|NCT03120611|Other|Virtual Reality Exercise|Game developed by the Kinect, adapted to the lying position of participants.
15968867|NCT03120611|Other|Conventional exercise intradialysis|Aerobic exercise (cycling) and strengthening exercise for lower limbs using elastic bands and gravity
15968868|NCT03120598|Behavioral|ATTC strategy|Addiction Technology Transfer Center (ATTC) strategy: A staff-focused strategy that includes 10 discrete strategies (e.g., centralized technical assistance, conduct educational meetings, provide ongoing consultation).
15968869|NCT03120598|Behavioral|ISF strategy|Implementation & Sustainment Facilitation (ISF) strategy: An organization-focused strategy that includes 7 discrete strategies (e.g., use of an implementation advisor, organize implementation team meetings, conduct cyclical small tests of change).
15968870|NCT03120585|Other|Fluid Management Intervention|Fluid management intervention is fluid restriction to 60 mL/kg/day on Day of Life (DOL) 1 for preterm and 40 mL/kg/day on DOL 1 for term neonates, calculated as total of IV and enteral fluid intake. Infants randomized to low infusion with be placed on 10% dextrose and the Infant will be monitored by obtaining serum glucose levels by point of care testing. Glucose infusion rates (GIR) would be calculated to the corresponding serum glucose and recorded. After 24 hours, infusion rate will be increased to 60ml/kg/d providing minimum GIR >4mg/kg/d. . Total fluid intake will be increased by 20 mL/kg/day until 150 mL/kg/day .
15968871|NCT03120559|Device|New Floss Holder - Gum Chucks|Dental inter-proximal control with GumChucks floss holder
15968872|NCT03120559|Device|New Floss Holder - Gum Chucks/SMS|Dental inter-proximal control with GumChucks floss holder and receiving 16 SMS during first 4 months.
15968873|NCT03120546|Device|rigid video stylet intubation|intubation using rigid video stylet
15968874|NCT03120546|Device|video laryngoscope intubation|intubation using video laryngoscope
15968875|NCT03120533|Drug|Iontophoresis of treprostinil|the participant will receive 10 days of iontophoresis of treprostinil on a first site
15968876|NCT03120533|Drug|Iontophoresis of placebo|the participant will receive 10 days of iontophoresis of NaCl on a second site, but the same time than treprostinil; it's like a design of cross-over study
15968879|NCT03120494|Drug|Emtricitabine and Tenofovir|All subjects will be provided study drug for use daily for one year.
15968880|NCT03120481|Other|no intervation|no intervention
15968881|NCT03120468|Drug|Topiramate and N-Acetyl Cysteine|Topiramate up to 200 mg/day and N-Acetyl Cysteine 600 mg twice a day for 12 weeks
15968882|NCT03120468|Drug|Topiramate and Placebo|Topiramate up to 200 mg/day and Placebo for 12 weeks
15968883|NCT03120455|Behavioral|Almond Group|Obese or overweight female adults will be randomly allocated to have almond as afternoon snacks, while they have a hypoenergetic diet.
15968884|NCT03120455|Behavioral|Pistachio Group|Obese or overweight female adults will be randomly allocated to have Pistachio as afternoon snacks, while they have a hypoenergetic diet.
15968885|NCT03120455|Behavioral|Nut free group|Obese or overweight female adults will be asked to avoid nuts, seeds and nut products, while they have a hypoenergetic diet.
15968886|NCT03120442|Drug|Propofol|target-controlled infusion starting for Cet 0.1 mcg/ml to achieve MOAA/S 3-4
15968887|NCT03120442|Drug|Dexmedetomidine|Incremental titration of dexmedetomidine starting from 0.1 mcg/kg/hr to achieve MOAA/S 3-4
15968888|NCT03120442|Drug|Fentanyl|0.25 mcg fo Fentanyl for anxiolysis
15968889|NCT03120429|Behavioral|Fish group|Fish group will have hypoenergetic diet in which subjects will have 3 x 150 g lean fish/ week at main meal
15968890|NCT03120429|Behavioral|Control group|Control group will have hypo-energetic diet in which subjects have no seafood.
15968891|NCT03120416|Behavioral|Resistance exercise training|12-week resistance exercise training program, 2 times per week, 45 min per session. Eight exercises will be used to include large upper and lower body muscle groups (leg press, leg extension, leg curl, chest press, shoulder extension, biceps curl, abdominal crunch and back extension). The baseline one repetition maximum will be used to set initial training loads.
15968892|NCT03120403|Procedure|intrathecal morphine|
15968893|NCT03120390|Other|Best Practice|Undergo usual care
15968894|NCT03120390|Behavioral|Exercise Intervention|Undergo AE
15968895|NCT03120390|Behavioral|Exercise Intervention|Undergo RE
15968896|NCT03120390|Other|Laboratory Biomarker Analysis|Correlative studies
15968897|NCT03120390|Device|Monitoring Device|Receive Polar heart rate monitor
15968898|NCT03120390|Other|Quality-of-Life Assessment|Ancillary studies
15968899|NCT03120390|Other|Questionnaire Administration|Ancillary studies
15968900|NCT03120377|Other|Platform|Whole body vibration training will consist of 12 consecutive weeks with two sessions per week on alternate days. Initially, before training with the vibratory platform, stretches lasting 5 to 10 minutes will be performed, with a series of 60 seconds for each of the following muscle groups: pectorals, sternocleidomastoids, scalenes, quadriceps and ischiatibial muscles. Patients will be monitored through vital signs for follow-up.
15968901|NCT03120377|Other|Platform sham|will receive the treatment without the therapeutic effect of the platform, but with vibrating platform connected with the display lit and a sound device coupled with a noise recording generated by the vibration, but without therapeutic purposes.
15968902|NCT03120364|Biological|NBP608|Preparation of Oka/SK strain of live, attenuated zoster virus
15968903|NCT03120364|Biological|Zostavax|Preparation of Oka/Merck strain of live, attenuated zoster virus
15968904|NCT03120351|Drug|Lidoderm 5 % Topical Patch|Patients will receive Lidoderm topical 5% lidocaine patches. Those will be placed to affected area up to three patches as needed for pain 12 hours on and 12 hours off
15968905|NCT03120351|Drug|Placebo patch|2) Group II: Patients will receive placebo patches. Those will be placed to affected area at dose up to three patches as needed for pain 12 hours on and 12 hours off
15968906|NCT03120338|Diagnostic Test|The Development and Wellbeing Assessment|The Development and Wellbeing Assessment (DAWBA: http://www.dawba.com/) is a computerised structured instrument for gathering diagnostic data from parents or guardians, teachers and young people themselves.
15968907|NCT03120325|Device|Vagal Nerve Stimulation|Patients will be giving themselves vagal nerve stimulation for four weeks at interval of two times a day for two minutes on each side for four weeks. The impact of the intervention on gastroparesis symptoms will be measured by upper endoscopy biopsies, blood work, autonomic function tests, survey data, stool samples, urine sample, and saliva samples before after after the four weeks of stimulation treatment.
15968908|NCT03120312|Procedure|total hip replacement|primary hip replacement patients during past 5 years．
15968909|NCT03120299|Drug|Omega-3 fatty acid|Omega-3 fatty acids capsules, 1 gram gel capsule, 2 capsules orally administered twice a day for 12 weeks
15968910|NCT03120299|Drug|Placebos|Matching placebo capsules, 1 gram gel capsule, 2 capsules orally administered twice a day for 12 weeks
15968911|NCT03120273|Drug|Dexlansoprazole Injection|15mg q12h,30mg q12h,15mg qd,30mg qd for 5 days
15968912|NCT03120273|Drug|Lansoprazole Injection|30 mg q12h for 5 days.
15968913|NCT03120260|Other|Diet|Intervention 'Diet+ short sleep versus normal sleep
15968914|NCT03120247|Drug|OTM Dexmedetomidine 1µg/ kg.|Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure.
15968915|NCT03120247|Drug|OTM Dexmedetomidine 0.75µg/ kg.|Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure.
15968916|NCT03120247|Drug|OTM Dexmedetomidine 0.5µg/ kg.|Oral transmucosal dexmedetomidine pharmacologically prepared as a jel substance will be administered to the buccal mucosa 30 mins before the operative procedure.
15968917|NCT03120234|Drug|Dexmedetomidine|
15968918|NCT03120234|Drug|Ketamine|
15968919|NCT03120234|Drug|Fentanyl|
15968920|NCT03120234|Drug|Placebos|o.9% normal saline will be used instead of ketamine
15968921|NCT03120221|Diagnostic Test|Urine sample for iodine measurement|Women will be required to give a urine sample for iodine measurement
15968922|NCT03120208|Behavioral|• The Edinburgh postnatal depression scale (EPDS), validated in French, with a discrimination threshold ≥ 11.|The Edinburgh postnatal depression scale (EPDS), validated in French, with a discrimination threshold ≥ 11.
15968923|NCT03120208|Behavioral|The GAD-7 with a discrimination threshold ≥10.|The GAD-7 with a discrimination threshold ≥10.
15969039|NCT03119324|Device|B-Cure® diode laser sham device|B-Cure laser® (Good Energies, Haifa, Israel) application by sham device twice a day for 7 consecutive days
15968924|NCT03120208|Behavioral|• Spielberger's State-Trait anxiety inventory, Form Y (validated in French), with a STAI (form Y-A) discrimination threshold ≥ 46|Spielberger's State-Trait anxiety inventory, Form Y (validated in French), with a STAI (form Y-A) discrimination threshold ≥ 46
15968925|NCT03120208|Behavioral|The IES-R, validated in French, with a discrimination threshold ≥ 30.|The IES-R, validated in French, with a discrimination threshold ≥ 30.
15968926|NCT03120208|Behavioral|EPDS, MINI, STAI-A and B, IES-R and QEVA (experience)|For the partners
15968927|NCT03120195|Device|The EndoRotor®|The EndoRotor® is in automated mechanical endoscopic mucosal resection system for use in the gastrointestinal tract. The EndoRotor suctions up the tissue and cuts it, automatically sending the tissue to a collection trap for histological evaluation.
15968928|NCT03120182|Drug|Acetylsalicylic acid|Patients will receive acetylsalicylic acid 100mg daily for 12 days after randomization
15968929|NCT03120182|Drug|Placebo Oral Tablet|Patients will receive placebo medication 100mg daily for 12 days after randomization
15968930|NCT03120169|Other|treadmill endurance training|n = 15 patients with COPD. Walking intensity will be initially set at 80 percent of 6-minute Walking test Speed with progressive increase in Duration and intensity.
15968931|NCT03120169|Other|cycling endurance training|n=15 patients with COPD. Cycling intensity will initially be set at 60 percent of Peak work rate with progressive increase in Duration and intensity
15968932|NCT03120156|Device|sensomotoric insoles|sensomotoric insoles were published by Jahrling (2007) and have a certain shape that could improve balance abilities. The toes 2-4 are higher that toe 1, so that the tendons of the toe-flectors are pre-stressed.
15968933|NCT03120156|Device|normal standard insoles|Normal standard insole like you will get them by receipe from an orthotic shop
15968934|NCT03120156|Other|No insoles|control group with no insoles in the shoes
15968935|NCT03120143|Other|Small-sided ball game training with high protein intake|In the present study, small-sided ball game training consists of repeated intervals of floorball and cone ball training on small areas and 3-4 participants on each team. The supplementation high in protein consists of 18 g protein consumed immediately after and 3 h post exercise
15968936|NCT03120143|Other|Small-sided ball game training with low protein intake|n the present study, small-sided ball game training consists of repeated intervals of floorball and cone ball training on small areas and 3-4 participants on each team. The supplementation low in protein consists of 3 g protein consumed immediately after and 3 h post exercise.
15968937|NCT03120130|Biological|Amblyomin-X|Intravenous drug administration, with different doses in each cohort
15968938|NCT03120117|Procedure|Cough Test following Sling Surgery|Enrolled subjects will undergo sling surgery who present with stress-dominated urinary incontinence. While in the operating room, the subject will be asked to stand and cough to determine if there is still leakage once the sling has been placed.
15968939|NCT03120104|Other|pelvic floor muscle exercise before stoma closure|pelvic floor muscle training for one month (2~3 times a week, for 4 weeks) just one month before the stoma closure
15968940|NCT03120104|Other|pelvic floor muscle exercise after stoma closure|pelvic floor muscle training for one month (2~3 times a week, for 4 weeks) just two weeks after the stoma closure
15968941|NCT03120091|Device|Real-time continuous blood glucose monitoring system(CGMS)|A total of 20 patients were enrolled for the place of CGMS.CGMS were placed on the right chest wall of each patients and recorded the interstitial glucose. Arterial blood glucose (ABG) were recorded every four hours. The duration of monitoring set was 5 days.CGMS were compared with ABG at the same time point. A total of 600 pairs of glucose level were collected
15968942|NCT03120065|Other|Electronic Dose Monitoring (MEMS)|The MEMS cap is an electronic bottle cap that records the time and date of a bottle being opened. The research personnel will extract the timing of the MEMS bottle opening events for adherence analysis.
15968943|NCT03120026|Dietary Supplement|Experimental product|Two servings (40 grams each) of powder (Fortifit; Nutricia) which has to be dissolved in 125 ml of water. Per serving, 20 g whey protein, 3 g total leucine, 9 g carbohydrates, 3 g fat, 800 IU vitamin D, and a mixture of vitamins, minerals, and fibers.
15968944|NCT03120026|Dietary Supplement|Isocaloric placebo|Two servings (40 grams each) of an isocaloric (maltodextrins) powder which has to be dissolved in 125 ml of water.
15968945|NCT03120013|Device|Anodal cerebellar and cathodal spinal tDCS|10 sessions of anodal cerebellar and cathodal spinal transcranial direct current stimulation (5 days/week for 2 weeks)
15968946|NCT03120013|Device|Sham cerebellar and sham spinal tDCS|10 sessions of sham cerebellar and sham spinal transcranial direct current stimulation (5 days/week for 2 weeks)
15968947|NCT03120000|Drug|PQR309|Oral PQR309, 80mg or 60mg daily or intermittent dosing
15968948|NCT03119987|Diagnostic Test|Red cell distribution widths|Measured value of Red cell distribution widths in initial laboratory result of blood cell counts at emergency department
15968949|NCT03119974|Drug|Tpo-RA discontinuation|a standardized strategy of dosage reduction will be implemented according to a predetermined scheme on persistent and/or chronic ITP patients who have previously achieved a stable and prolonged (> 2 months) complete response (platelets counts > 100 x 109/L) period on Tpo-RA treatment.
15968950|NCT03119961|Device|SONOCLOUD®|BBB opening by ultrasound
15968951|NCT03119948|Drug|Placebo injection|"Placebo in soleus and placebo in rectus femoris, and placebo in additional muscles as per investigator's choice among tibialis posterior, toe flexors (long or short), gastrocnemius muscles or peroneus longus.
~150U (x 7.5 ml) placebo Sol + 150U (x 7.5 ml) placebo RF + 100U (5ml) placebo distributed between tibialis posterior, FHL (flexor hallucis longus), FCB (flexor digitorum brevis), gastrocnemius muscles or peroneus longus, based upon investigator clinical judgment"
15968952|NCT03119948|Drug|Botulinum toxin injection|"Botulinum toxin type A in soleus and in rectus femoris, and Botulinum toxin type A in additional muscles as per investigator's choice among tibialis posterior, toe flexors (long or short), gastrocnemius muscles or peroneus longus.
~150U (x 7.5 ml) Xeomin® 20U/ml Sol + 150U (x 7.5 ml) Xeomin® 20U/ml RF + 100U (5ml) Xeomin® distributed between tibialis posterior, FHL (flexor hallucis longus), FCB (flexor digitorum brevis), gastrocnemius muscles or peroneus longus, based upon investigator clinical judgment."
15969064|NCT03119051|Behavioral|Online cognitive training|A variety of cognitive domains will be involved in the training including memory, calculation, attention, visuospatial and executive skills. The difficulty level of each game will be adjusted automatically according to patients' last training results so that patients' correction rate will be kept between 70% and 80%.
15968953|NCT03119948|Drug|Placebo injection and botulinum toxin injection|"Botulinum toxin type A in soleus and placebo in rectus femoris, and Botulinum toxin type A in additional muscles as per investigator's choice among tibialis posterior, toe flexors (long or short), gastrocnemius muscles or peroneus longus..
~150U (x 7.5 ml) Xeomin® 20U/ml Sol + 150U (x 7.5 ml) placebo RF + 100U (5ml) Xeomin® distributed between tibialis posterior, FHL (flexor hallucis longus), FCB (flexor digitorum brevis), gastrocnemius muscles or peroneus longus, based upon investigator clinical judgment."
15968954|NCT03119935|Device|Amflow|Amflow deviced was developed for monitoring ventiation rate and ventilation volume. Participants ventilated the simulated patients by Amflow-device assist ambu bag
15968955|NCT03119935|Device|Ambu bag|Participants ventilated the simulated patients by ambu bag
15968956|NCT03119922|Other|No intervention|
15968957|NCT03119909|Other|First session of fMRI: localization of the premotor areas of the medial frontal cortex|Subjects should perform simple tasks to map the premotor areas of the medial frontal cortex. In this context, they will have to perform hand, tongue, ocular movements for about 20s. Additionally, as part of a control condition, they will need to perform eye fixation on a cross shown at the center of the screen for about 20s.
15968958|NCT03119909|Other|Second fMRI session|The subjects will position their left and right thumbs on response buttons. Each trial will begin with the appearance of one of 2 possible indexes. It will be an unknown abstract visual stimulus). After a variable delay of 0.5 to 6s (average = 2s), a blue or yellow circle will appear on the left or right of the screen.
15968959|NCT03119909|Other|Third fMRI Session|This session is identical to the second session but the subject will have to respond by performing saccadic ocular responses.
15968960|NCT03119909|Other|Training fMRI session|The training session will consist in training the subject to carry out the different behavioral tasks that he will then have to perform during the sessions of fMRI.
15968961|NCT03119909|Other|Pilot behavioral study|In a pilot study, 30 subjects will participate in a behavioral study (2 sessions of 2 hours each) aimed at establishing the learning characteristics of the different types of rare events unrelated to actions (visual and sensorimotors on the hand).
15968962|NCT03119909|Other|fMRI Study|Each subject will participate in 2 fMRI sessions of about 2 hours each: a first session in which a first version of the task will be presented and a second session in which the second version of the task will be presented.
15968963|NCT03119896|Other|The Navigator Tool Intervention|The intervention consists of two parts; a training session on self-management of chronic conditions for the healthcare professionals, and a paper-based tool for the patients. Both parts aim to inform and prepare the two parties as to what self-management entails in order to facilitate a constrictive consultation.
15968964|NCT03119883|Other|Infusion of 13-Carbon labeled Glutamine|Intravenous infusion of 13-Carbon labeled glutamine followed by bone marrow aspiration
15968965|NCT03119870|Other|Train|Each subject will be trained to perform a trial-error learning task. In this task, three visual stimuli will be presented to the subject. The subject will have to find by trial-error, the one associated with positive feedback, the other stimuli being associated with negative feedback (search period). Once the stimulus is associated with positive feedback, the subject will perform a period of repetition during which he will choose the stimulus associated with positive feedback. Two variants of the task will be used: a variant in which feedback will be visual (ie positive feedback = green square, negative feedback = red square) and a variant in which feedback will be fruit juice (ie positive feedback = Fruit juice (but less than 2ml), negative feedback = no volume or small volume of fruit juice).
15968966|NCT03119870|Other|MRI|Once the tasks are learned, each subject will participate in an MRI session during which an anatomical scan will be obtained. For each task, the time of presentation of the stimuli will be 2s. During this time, the subject should indicate his choice of stimulus. After a delay of 2s, feedback will be presented for 1s. Each test shall be separated by an inter-test delay of 3s. The presentation of the stimuli and the control of the answers will be managed by the E-prime or Presentation software.
15968967|NCT03119870|Other|EEG|Once the tasks are learned, each subject will participate in an MRI session during which an anatomical scan will be obtained and then an EEG session during which he will perform the task learned.For each task, the time of presentation of the stimuli will be 2s. During this time, the subject should indicate his choice of stimulus. After a delay of 2s, feedback will be presented for 1s. Each test shall be separated by an inter-test delay of 3s. The presentation of the stimuli and the control of the answers will be managed by the E-prime or Presentation software.
15968968|NCT03119857|Drug|Antiandrogen|
15968969|NCT03119857|Drug|Antiandrogen+docetaxel|"Antiandrogen (bicalutamide 150 mg x 1) + docetaxel (Taxotere®) 75mg/m2 (max 2.0m2) i.v. in 60 minutes on day 1. One cycle is 21 days. Docetaxel will be given for up to 8-10 cycles or until unacceptable toxicity or consent withdrawal whichever comes first.
~Antiemetic therapy may be used if necessary."
15968970|NCT03119844|Other|Exercise|The exercise will be performed in a cycle ergometer, intermittently, during 40 minutes, in a moderate intensity and prescribed by the perceived exertion Borg (PEB) scale.
15968971|NCT03119844|Other|Placebo Phototherapy|Patients will receive the placebo application of low level laser therapy (parameters: 808nm, 100mW, 28J) in the rectus Femoris and gastrocnemius muscles of both lower limbs before the performance of the cycle ergometer exercise protocol.
15968972|NCT03119844|Other|Active Phototherapy|Patients will receive the active application of low level laser therapy (parameters: 808nm, 100mW, 28J) in the rectus Femoris and gastrocnemius muscles of both lower limbs before the performance of the cycle ergometer exercise protocol.
15968973|NCT03119831|Drug|Alcohol-based Chlorhexidine Gluconate 0.12%|Rinsing with 15ml for one minute twice daily for 14 days
15968974|NCT03119831|Drug|Alcohol-free Chlorhexidine Gluconate 0.12%|Rinsing with 15ml for one minute twice daily for 14 days
15968975|NCT03119831|Drug|C31G|Rinsing with 15ml for one minute twice daily for 14 days
15968976|NCT03119818|Device|Phosphorus (31P) magnetic resonance spectroscopy|Phosphorus MR spectroscopy realized using a 3-Tesla MR imaging system. A twenty-cm circular surface coil will be set to the 31P resonance frequency and placed over the leg muscle region to obtain spectroscopy acquisitions. 31P MR spectra will be acquired before, during (every 160 seconds), and 30 minutes after dialysis. 31P MR system data will be analyzed using jMRUI Software. Five different peaks will be analyzed: inorganic phosphate, phosphocreatine, α-, β-, and γ-ATP.
15969143|NCT03118479|Drug|Testosterone|Androgel 7.5 g to be applied transdermally daily for 3 months.
15968977|NCT03119818|Other|Hemodialysis|Hemodialysis realized using a 5008 generator, a portable plant, a FX80 Dialyzer, a dialyzing solution with a standard electrolytes composition. The dialysis generator will be placed outside of the MRI examination room. The dialysis lines will pass through a wave guide to connect patients positioned on the bed of the MRI. A suitably trained nurse will proceed to the cannulation of the fistula, the connection of the catheter, and the monitoring of the clinical tolerance of the session.
15968978|NCT03119792|Other|Education Intervention|The education intervention will help increase the children's knowledge of attitudes, and habits of healthy lifestyles. The program will cover self care of the body and heart, emotional management, healthy diet, and physical activity.
15968979|NCT03119792|Other|Control|"The control will not receive an education program relating to knowledge, attitudes, nor habits of healthy lifestyles. Instead, these sessions will occur twice a month, and will last an hour and forty-five minutes. The control program is titled Life's Challenges, which will focus on helping children develop skills necessary for day to day life, is divided into four modules: Person, Family, School, and Environment. There will be four different types of activities used throughout the program including: Lets Think, Lets Experiment, We will finish with...or synthesis, and Not here."
15968980|NCT03119779|Drug|MTA-Anglus|MTA-Anglus freshly mixed according to manufacturer instructions over glass slap and applied to pulp stump and application of wet cotton for 15 min. till initial setting occur.
15968981|NCT03119779|Drug|TheraCal|TheraCal directly applied from the syringe container tip to pulp stump over incremental layers each layer should not exceed 1 mm thickness and each layer will be light cured for 20 sec.
15968982|NCT03119766|Drug|Kolofort|Safety and Efficiency
15968983|NCT03119766|Drug|Placebo|Safety and Efficiency
15968984|NCT03119753|Device|Rapid Prototyping method of fabrication of complete denture|For Rapid Prototyping Method of fabrication of complete denture : the master casts will be scanned using DENTAL WINGS eco-scan 3, using laser technology for scanning, after spraying the stainless steel pins with scanning spray to be recorded into the denture base. Virtual model will be obtained for fabrication of denture bases. Denture base will be designed and modified on the virtual model, then it will be printed using ZENITH-3D Printer using Urethane acrylate oligomer based photo-polymerized resin.
15968985|NCT03119753|Device|Conventional method of fabrication of complete denture|For Conventional Method of fabrication of complete denture: Self-cured acrylic resin trial denture bases will be constructed on the obtained master casts, then processing of the final denture bases by conventional clamping method cured by long curing cycle (74º C for 8 hours) using heat-cured poly-methyl methacrylate (PMMA) resin material. The position of the pins will be recorded into the denture bases so that the linear changes could be measured.
15968986|NCT03119727|Device|FreeO2|All include patients will have automatic administration of oxygen by FreeO2 up to 3 day or until weaning of oxygen adminisatrion
15968987|NCT03119714|Drug|Pemirolast|Treatment with pemirolast 200 mg bid for 14-16 days
15968988|NCT03119714|Drug|Placebo Oral Tablet|Treatment with placebo bid for 14-16 days
15968989|NCT03119701|Drug|Interferon Beta-1A|Lyophilisate for solution for injection.
15968990|NCT03119701|Drug|Placebo|Lyophilisate for solution for injection as placebo.
15968991|NCT03119688|Other|Test Product|Micellar cleanser (0.09 ml)
15968992|NCT03119688|Other|Positive Control|Bar Soap (rubbed for 6 seconds to generate a lather)
15968993|NCT03119688|Other|Reference Product|Sterile Water (0.09 ml)
15968994|NCT03119688|Other|No Treatment|Unwashed area of the forearm
15968995|NCT03119675|Device|GoCheck Kids (iOS)|Photorefraction method is used to screen amblyopia risk factors.
15968996|NCT03119675|Device|GoCheck Kids (Windows)|Photorefraction method is used to screen amblyopia risk factors.
15968997|NCT03119662|Drug|Visipaque|100 mL iodixanol (Visipaque Injection 320 mg I/mL), followed by a 10 mL saline flush to ensure delivery of the full dose of Visipaque.
15968998|NCT03119662|Drug|Placebos|100 mL saline, followed by a 10 mL saline flush.
15968999|NCT03119649|Drug|GLPG2222 50 mg|Oral tablet(s) containing GLPG2222
15969000|NCT03119649|Drug|GLPG2222 100 mg|Oral tablet(s) containing GLPG2222
15969001|NCT03119649|Drug|Placebo|Matching oral tablet(s) containing placebo
15969002|NCT03119649|Drug|GLPG2222 200 mg|Oral tablet(s) containing GLPG2222
15969003|NCT03119649|Drug|GLPG2222 400 mg|Oral tablet(s) containing GLPG2222
15969004|NCT03119636|Biological|NPC transplantation|The cells are stereotactically implanted in the striatum.
15969005|NCT03119636|Drug|Levodopa|Levodopa is used depending on the patient's condition
15969006|NCT03119623|Drug|sacubitril/valsartan|Sacubitril/valsartan 100mg titrated up to sacubitril/valsartan 200mg
15969007|NCT03119623|Drug|Enalapril|enalapril 5mg, titrated up to 10mg po BID
15969010|NCT03119597|Dietary Supplement|Wild Blueberry Powder-13g|Formulation containing approximately 250mg of anthocyanin+ 4.79g Fructose+ 4.52g Glucose+ 45mg Vitamin C
15969011|NCT03119597|Dietary Supplement|Placebo|Formulation containing approximately 4.79g Fructose+ 4.52g Glucose+ 45mg Vitamin C
15969012|NCT03119584|Drug|linaclotide or placebo|
15969013|NCT03119571|Procedure|Initial CCL admission|Admission to the cardiac catheterization lab to evaluated coronary artery disease and if present fix the culprit lesion/lesions
15969014|NCT03119571|Diagnostic Test|Initial ICU admission|Evaluate for additional testing and/or procedures
15969015|NCT03119558|Drug|18F-Florbetaben (Neuraceq®) PET/MRI|Administration of 8.0 mCi 18F-Florbetaben (Neuraceq®) IV followed by simultaneous acquisition PET emission and cardiac MRI sequence scan 45-60 minutes post-injection.
15969040|NCT03119324|Drug|Nimesulide Ratiopharm® and Flexiban®|Five consecutive days assumption of Non Steroidal Anti Inflammatory drug, Nimesulide Ratiopharm® 50mg twice a day, followed by five consecutive days assumption of Myorelaxant, Flexiban®, 10mg once a day, followed by five consecutive days assumption of 50mg of Non Steroidal Anti Inflammatory drug, Nimesulide Ratiopharm®, twice a day
15969041|NCT03119311|Diagnostic Test|Video-oculography|Diagnostic Method for Exotropia Using Video-oculography
15969042|NCT03119311|Diagnostic Test|APCT|alternative prism cover test
15969016|NCT03119545|Behavioral|Beardslee family centered intervention|The method entails six meetings. The time for the meeting is 1-2 hours and is usually held once per week. Meetings 1 and 2) include only the parents and focus firstly on the ill parent's history and secondly on the well parent/relative. Meeting 3) includes interviews with each child aged 6-19 years, without the parents being present, concerning the child´s understanding of the disease, potential worries and questions. During the interview the child can formulate his or her own questions for the family meeting. Meeting 4) includes the parents and focuses on the planning of the family meeting. The child's thoughts and questions serve as a guide for the upcoming family meeting. Meeting 5) is the family meeting. Meeting 6) is a follow-up with all of the family members.
15969017|NCT03119532|Other|Receive metric feedback email|If the provider received an email about the participants performance metrics
15969018|NCT03119519|Radiation|Local Definitive Radiotherapy|three-dimensional conformal therapy or intensity modulated radiation therapy
15969019|NCT03119519|Drug|No Local Definitive Radiotherapy|Standard platinum-based doublet chemotherapy or EGFR-TKI (Gefitinib or Erlotinib) alone, according to gene test.
15969020|NCT03119506|Behavioral|Recess|Recess timing and duration effects on lunch intake
15969021|NCT03119493|Behavioral|Periodized aerobic interval training|The periodized training program consist in 3 phases: light (I) (training range varying between 20 to 39% of heart rate reserve and active recuperation of 19% of heart rate reserve); moderate (II) (training range varying between 40 to 59% of heart rate reserve and active recuperation of 30% of heart rate reserve) and high (III) (training range varying between 70 to 90 % of heart rate reserve and active recuperation of 50% of heart rate reserve).
15969022|NCT03119480|Device|electronic alerts|electronic alerts for AKI
15969023|NCT03119467|Drug|RP4010|Escalating doses starting at 25 mg
15969024|NCT03119454|Drug|Diprospan|Intramuscular
15969025|NCT03119441|Device|Dental Water Jet|Dental Water Jet will be used by subjects to clean their teeth in the interproximal areas.
15969026|NCT03119441|Device|Dental Floss|Dental Floss will be used by subjects to clean their teeth in the interproximal areas.
15969027|NCT03119428|Drug|OMP-313M32|OMP-313M32 is a monoclonal antibody which binds to the human TIGIT receptor on T cells.
15969028|NCT03119428|Drug|Nivolumab|Human IgG4 anti-PD-1 monoclonal antibody
15969029|NCT03119415|Behavioral|Cooperative Learning|CL is an umbrella term that includes peer tutoring, reciprocal teaching, collaborative reading, and other methods in which peers help each other learn in small groups. CL is not prescriptive but rather is a conceptual framework within which teachers design their own small-group activities. Johnson, Johnson, and Holubec's approach to CL combines positive interdependence with individual accountability, a high degree of face-to-face social interaction among youth, and support for the development of cooperative social skills. The Johnsons' approach offers teachers the combination of specific cooperative activities and the conceptual tools to create their own lesson plans using positive interdependence.
15969030|NCT03119402|Behavioral|Rhythmic Reading Training|RRT is a computerized reading training program designed for Italian students with dyslexia. The main feature of this intervention is the integration of a traditional remediation approach (sublexical treatment) with rhythm processing. Therefore, all reading exercises are characterized by a rhythmic accompaniment with gradually increasing speed.
15969031|NCT03119402|Device|Transcranial direct current stimulation|tDCS (transcranial direct current stimulation) is a noninvasive weak-current brain stimulation technique that can facilitate (anodal electrode) or inhibit (cathodal electrode) cortical activity, thus offering exciting possibilities for the enhancement and treatment of impaired cognitive abilities.
15969032|NCT03119389|Behavioral|Donning Non-Sterile Gloves without HH|Current practice is to perform hand hygiene before donning of non-sterile gloves. In units assigned to the intervention, healthcare workers within the units will be educated that performing hand hygiene before donning non-sterile gloves is not necessary.
15969033|NCT03119376|Other|COBPEER|At the end of the online training, they can participate in the study and so peer review 1 manuscript randomly selected from our sample with our tool (COBPeer).
15969034|NCT03119363|Device|AYO light glasses (Experimental)|The AYO does not contain UV or infra-red light; the light spectrum begins at approximately 420nm. The circadian-effective AYO is programed at over 100 lux with 470nm frequency and irradiance of 250 qW/cm2, which is 100% intensity level. Irradiance over lux itself with AYO light glasses is believed to be more representative due to light frequency and proximity to the eye. Traditional Lightbox usual measure is Lux , AYO can be seen as comparable to 1,000 lux light box. The device is classified as a device that is safe for the eyes in accordance with the international standard IEC 62471 and is independently certified by TÜV Rheinland. AYO complies with the EU's CE marking (CE EMC EN 55014, EN 61000-4-3) as well as other national regulatory directives. AYO also complies with the United States of America's FCC marking (FCC Title 47, Chapter 1, Part 15, Class B FCC VOC: 47 CFR PART 15 OCT, 2016. CLASS B ANSI C 63.4: 2014) as well as other national marking regulatory directives.
15969035|NCT03119363|Device|AYO light glasses (Comparator)|The comparison group will wear the same AYO glasses, but with a circadian ineffective (sham) light. The circadian-ineffective (sham) is programed at 1% intensity, therefore according to our calculation and checks it is below circadian threshold of 2 lux as specified.
15969036|NCT03119350|Other|Physical Training|"Intervention with concurrent physical training: strength and aerobic exercises in the same session.
~Duration: 2 weeks of adaptation to physical exercise, 8 weeks of training. Frequency: 3 times a week. Time: 55 minutes each session. Intensity: 75 to 90% of maximum heart rate."
15969037|NCT03119337|Other|Text-based follow-up|2wT clients will receive automated daily texts from days 1-14. If a 2wT VMMC client responds that he suspects an AE, a VMMC nurse will exchange modifiable, scripted texts with clients to determine symptoms, frequency, and severity. Then, if deemed necessary, the client will be asked to return to clinic the following day or earlier. If 2wT patients do not respond to texts on Day 2 or Day 7, the same MoHCC tracing process will be activated, after which they will be considered LTFU. All study participants will be asked to come to the clinic for study-specific, Day 14 follow-up to review healing and verify adverse event reporting. At Day 42, we will implement a brief text-based survey with 2wT clients to ascertain complete healing, providing stronger inferences at study completion.
15969038|NCT03119324|Device|B-Cure® diode laser|B-Cure laser® (Good Energies, Haifa, Israel) 808nm diode laser application in contact mode over painful area twice a day for 7 consecutive days
15969144|NCT03118479|Drug|Placebo Oral Tablet|One tablet to be taken daily for 3 months
15969043|NCT03119259|Behavioral|ABC Clinical Program|"The goal of the ABC Clinical Program is to help primary care physicians achieve the standard of care in the diagnosis, evaluation and management of patients with ADRD. The ABC Clinical Program is delivered by an interdisciplinary team led by a care coordinator. The informal caregiver is also enrolled in the program and caregiver burden is assessed and managed. The ABC team collects all relevant data and formulates an individualized care plan in collaboration with the informal caregiver. The care coordinator communicates the team's recommendations to the primary care physician and finalizes a collaborative plan of action. During the next year, the ABC team uses face-to-face and telephone interactions with the patient and caregiver to monitor and modify implementation of the care plan.
~The goal of IUHP Usual Care is to provide preventive care services to their patients. Older adults are assessed for ADRD during clinic visits and refered to brain care specialty as necessary."
15969044|NCT03119259|Behavioral|BCN|"BCN is a mobile application (app) for informal caregivers of patients with Alzheimer's Disease and related dementias (ADRD). The BCN app delivers the following behavioral support:
~24/7 psychoeducation and caregiver support on a variety of ADRD related topics, presented as a browse-able library of stories and advice cards or Notes;
~Assessment of informal caregiver status and patients behavioral and psychological symptoms of dementia (BPSD), in the form of the selfadministered HABC Monitor, along with reporting and historical tracking of HABC Monitor scores;
~Engagement tools, in particular, (i) a toolkit for saving, sorting, creating/editing, and sharing Notes and (ii) a bi-directional messaging tool for communicating with clinicians or trusted others."
15969045|NCT03119246|Other|CAPIT-HD beta|New assessment protocol for assessment of complex therapies in Huntington's disease for both groups
15969046|NCT03119233|Device|PQ Bypass System|Intended use from CLN114 Rev F (CLN114 is the DETOUR2 protocol) The PQ Bypass System is intended to improve blood flow in patients with peripheral arterial disease in symptomatic femoropopliteal lesions due to chronic total occlusions ≥ 20 cm (TASC D) that can include de novo, restenotic, or in-stent restenotic lesions; or total lesion lengths ≥24 cm that can include chronic total occlusions or a ≥70% lesion that includes de novo, restenotic or in-stent restenosis (complex TASC C).
15969047|NCT03119220|Device|Fitbit One|Participants will receive a Fitbit device and a detailed user manual as well as diary materials to record daily steps taken, miles walked, and flight of stairs walked for a total of 12 weeks. An in-person follow-up meeting will be scheduled 7 days after the initial meeting to establish the baseline activity level of the participant and to determine the target number of daily steps for the subsequent 5 blocks of 2 weeks.
15969048|NCT03119207|Behavioral|Naptime Protocol|Between midnight and 4:00 every attempt will be made to limit staff entrance into the patient room.
15969049|NCT03119194|Drug|[14C]-BIA 9-1067|1 × 100 mg capsule, Oral
15969050|NCT03119181|Drug|Tymbion Lidocaine/epinephrine solution|The external ear canal will be filled with Tymbion drug solution
15969051|NCT03119181|Combination Product|Device: Iontophoresis System (IPS) with Drug: Tymbion lidocaine/epinephrine solution|The external ear canal will be filled with Tymbion drug solution. The Iontophoresis System (IPS) will be used to deliver current to the Tymbion solution to facilitate drug penetration into the tympanic membrane (TM) tissue to anesthetize (numb) the TM
15969052|NCT03119168|Drug|Simethicone Solution|Patients will be assigned randomly to take Simethicone Solution plus polyethylenglycol
15969053|NCT03119168|Other|Polyethylenglycol|Patients in this arm will be randomly assigned to take polyethylenglycol as their regular bowel preparation
15969054|NCT03119129|Behavioral|Ho'ouna Pono Drug Prevention Curriculum|Ho'ouna Pono is a school-based, culturally grounded drug prevention curriculum tailored to Native Hawaiian and Pacific Islander youth on Hawai'i Island.
15969055|NCT03119116|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Oral direct factor Xa inhibitors, 15mg and 20mg tablets QD
15969056|NCT03119116|Drug|Dabigatran|Oral direct thrombin inhibitors, 75mg and 150mg capsules BID
15969057|NCT03119116|Drug|Apixaban|Oral direct factor Xa inhibitors, 2.5mg and 5 mg tablets BID
15969058|NCT03119103|Device|Functional Bed Sheet|All participants sleep on the functional bed sheet that is placed under a normal bed sheet. The device collects pressure sensor information and informs on body position, respiration rate, and respiration patterns.
15969059|NCT03119077|Drug|BAY1161116|Escalating doses of BAY1161116; single dose administration; redosing of BAY1161116 at dose group 1 together with itraconazole; redosing of BAY1161116 at dose group 2 as liquid service formulation, redosing of BAY1161116 at dose group 3 together with food
15969060|NCT03119077|Drug|Placebo|Escalating doses of respective placebos; single dose administration; redosing of placebo at dose group 1 together with itraconazole; redosing of placebo at dose group 2 as liquid service formulation, redosing of placebo at dose group 3 together with food
15969061|NCT03119077|Drug|Itraconazole|Redosing of BAY1161116/placebo at dose group 1 together with itraconazole
15969062|NCT03119064|Drug|Nanoliposomal Irinotecan|Three patients will be accrued to level 1. If no dose limiting toxicities are observed following completion of 4 weeks (2 cycles) of treatment then accrual to dose level 2 will proceed (patients must be evaluated prior to their cycle 3 treatment and this will be used to confirm DLTs). If a DLT is observed in one of the first 3 patients in a dose level, then accrual for that level will be expanded to 6 patients. Accrual will continue in this way until the MTD of nanoliposomal irinotecan with temozolomide 50mg/m2/day is determined. Two or more instances of DLT in a cohort of 6 patients will result in the preceding dose level being defined as the MTD. If two or more instances of DLT in a cohort of 6 patients occurs in dose level 1 then dose level -1 of nanoliposomal irinotecan will be investigated. After determination of the MTD, the final cohort will be expanded so that a total of 25 patients are treated on study. The final cohort will be treated at the MTD.
15969063|NCT03119064|Drug|Temozolomide|Three patients will be accrued to level 1. If no dose limiting toxicities are observed following completion of 4 weeks (2 cycles) of treatment then accrual to dose level 2 will proceed (patients must be evaluated prior to their cycle 3 treatment and this will be used to confirm DLTs). If a DLT is observed in one of the first 3 patients in a dose level, then accrual for that level will be expanded to 6 patients. Accrual will continue in this way until the MTD of nanoliposomal irinotecan with temozolomide 50mg/m2/day is determined. Two or more instances of DLT in a cohort of 6 patients will result in the preceding dose level being defined as the MTD. If two or more instances of DLT in a cohort of 6 patients occurs in dose level 1 then dose level -1 of nanoliposomal irinotecan will be investigated. After determination of the MTD, the final cohort will be expanded so that a total of 25 patients are treated on study. The final cohort will be treated at the MTD.
15969065|NCT03119051|Behavioral|Cognitive training plus physical exercise|"Online cognitive training A variety of cognitive domains will be involved in the training including memory, calculation, attention, visuospatial and executive skills. The difficulty level of each game will be adjusted automatically according to patients' last training results so that patients' correction rate will be kept between 70% and 80%.
~Physical Exercise Tai Chi Training：a teacher will give two 60-min lessons per week. Participants will play Tai Chi in the lessons, following teacher's instruction."
15969066|NCT03119038|Drug|Bupivicaine + epinephrine|Intraoperative periarticular injection of 30 mL of a 0.25% solution bupivacaine with epinephrine
15969067|NCT03119038|Drug|Bupivacaine|Intraoperative periarticular injection of 30 mL of a 0.25% solution bupivacaine without epinephrine
15969068|NCT03119038|Drug|Ropivacaine|Intraoperative periarticular injection of 300 mg of 0.5% ropivacaine
15969069|NCT03119038|Drug|Ketorolac|Intraoperative periarticular injection of 30 mg
15969070|NCT03119038|Drug|Clonidine Injection|Intraoperative periarticular injection of 100 mcg clonidine in a 100 mL 0.9% saline solution
15969071|NCT03119025|Biological|Autologous DC-vaccines|"Patients will be vaccinated via intracutaneous injection of autologous DCs (5×106) combined with adjuvant subcutaneous injection of recombinant hIL-2 (250 000 IU).
~Initiating course: one vaccination per week, during 1 month. Maintaining course: one vaccination per month, during 6 month. Patients will be monitored in a 2 months (after completing of initiating course), 7 months (after completing of maintaining course) and 13 months (in a 6 months post-vaccination follow-up)."
15969072|NCT03119012|Drug|Clopidogrel|75mg/day
15969073|NCT03119012|Drug|Ticagrelor|120mg/day
15969074|NCT03119012|Drug|Aspirin|100mg/day
15969075|NCT03118999|Dietary Supplement|OM3-FFA|Comparison of the effects of OM3-FFA versus OM3-MAG and OM3-EE in a crossover design
15969076|NCT03118999|Dietary Supplement|OM3-MAG|Comparison of the effects of OM3-MAG versus OM3-FFA and OM3-EE in a crossover design
15969077|NCT03118999|Dietary Supplement|OM3-EE|Comparison of the effects of OM3-EE versus OM3-FFA and OM3-MAG in a crossover design
15969078|NCT03118986|Drug|Olanzapine|olanzapine 0.1 mg/kg/dose (maximum 10 mg/dose) by mouth as a single daily dose based on actual body weight
15969079|NCT03118986|Drug|Placebo Oral Tablet|Placebo tablets that look like olanzapine and will be dosed as if they are olanzapine
15969080|NCT03118973|Procedure|Goff trans-pancreatic septotomy vs. Double wire technique|Goff trans-pancreatic septotomy vs. Double wire technique for achieving biliary access when biliary cannulation is challenging.
15969081|NCT03118960|Device|Freedom Bed|This is an automatic rotational system in a bed designed to disburse capillary pressure
15969082|NCT03118960|Device|Group II Low Air Loss/Alternating Pressure Mattress|Subjects placed on the Group II Low Air Loss/Alternating Pressure Mattresses will require manual repositioning every 2 hours
15969083|NCT03118947|Drug|Pimavanserin|Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth, OR Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth
15969084|NCT03118934|Device|Lotrafilcon B multifocal contact lenses|Contact lenses for near, intermediate, and distance correction worn on a daily wear basis and cared for with participant's habitual lens care solution
15969085|NCT03118934|Device|Nelfilcon A multifocal contact lenses|Contact lenses for near, intermediate, and distance correction worn on a daily disposable basis (removed every night and discarded) with a new pair of study lenses every morning
15969086|NCT03118934|Device|Delefilcon A multifocal contact lenses|Contact lenses for near, intermediate, and distance correction worn on a daily disposable basis (removed every night and discarded) with a new pair of study lenses every morning
15969087|NCT03118921|Device|Virtual reality|The first session aims to present the virtual reality material that will be used. The second session will take place 2 weeks after the first session and will consist of the use of the immersion software.
15969088|NCT03118908|Dietary Supplement|Amberen|Amberen is a succinate-based dietary supplement previously shown to help provide relief for common menopausal symptoms.
15969089|NCT03118908|Dietary Supplement|Smart B|Smart B contains vitamins B1, B2, B6, B9, B12 and sodium fumarate.
15969090|NCT03118908|Dietary Supplement|Placebo|Placebo capsules are identical to Amberen and Smart B capsules.
15969091|NCT03118895|Device|BioFreedom™ BA9™ drug-coated stent|Drug-coated stent for coronary arteries
15969092|NCT03118882|Behavioral|Diet group|A meeting where an expert illustrates the scientific basis of a proper diet. Moreover, clear and practical indications for dietary habits improvement and for suggested food purchase are provided. After having completed the basic module, participants are offered the opportunity of deepening the educational process through an advanced module:hree theoretical and practical cooking meetings (total of 10 hours) held by cooks with an expertise in natural cuisine and by trained dieticians.
15969093|NCT03118882|Behavioral|Physical activity group|A meeting where an expert illustrates the benefits of a constant PA. Moreover, indications are given on sport opportunities and walking groups in the city organised by public authorities. After having completed the basic module, participants are offered the opportunity of deepening the educational process through an advanced module: three theoretical and practical lessons (total of 10 hours) held by expert physical trainers.
15969094|NCT03118882|Behavioral|Physical activity and diet group|A meeting where the indications given to the previous groups are presented simultaneously. Particular attention is paid to the interaction between the two activities. After having completed the basic module, participants are offered the opportunity of deepening the educational process through an advanced module: four theoretical and practical meetings (total of 12 hours), two lessons focus on diet and two on PA.
15969095|NCT03118856|Diagnostic Test|Prediction of Histology|The accuracy of predicting the histology of colorectal polyps will be assessed with HD-WLE and EC
15969096|NCT03118843|Drug|SOF/VEL/VOX|400/100/100 mg FDC tablet administered orally once daily with food
15969097|NCT03118830|Drug|Triptorelin|daily SC injection of Triptorelin 0.1 mg started at day 21 of the cycle prior to stimulation cycle and continued till the day of hCG triggering.
15969098|NCT03118830|Drug|cetrorelix|Flexible GnRH antagonist protocol was done with daily s.c administration of cetrorelix 0.25 mg started when one or more of the following criteria were achieved: (i) one or more follicle reached 14 mm diameter; (ii) The level of serum E2 reached 600 pg/ml; and (iii) The level of serum LH levels reached 10 IU/l .
15969339|NCT03117296|Other|Routine PT or OT|Routine PT or OT consulted by physician when identified discharge disposition of home
15969099|NCT03118830|Drug|Recombinant Follicle Stimulating Hormone|Daily sc rFSH (Gonal-f; Merck Serono , Darmstadt, Germany) injections was started on 2nd day of the cycle in the antagonist protocol. Continuation of rFSH and GnRH antagonist daily until triggering day was done.
15969100|NCT03118817|Drug|HM95573|"Dose: 450 mg BID
~Regimen: twice daily (BID), continuous dosing
~Duration: until progression disease or unacceptable toxicity develops"
15969101|NCT03118804|Diagnostic Test|Assessment of Lung Tidal Distribution With EIT|Changes of lung tidal distribution during SBT with mechanical ventilation were recorded by EIT can be used to predict weaning success or failure
15969102|NCT03118791|Dietary Supplement|anthocyanins|Acute intake of capsules
15969103|NCT03118765|Drug|GSP304 (tiotropium bromide) Inhalation Solution|Once daily (QD) oral inhalation using a nebulizer
15969104|NCT03118765|Drug|GSP304 Placebo Inhalation Solution|Once daily (QD) oral inhalation using a nebulizer
15969105|NCT03118765|Drug|Spiriva® Respimat® inhalation spray|Once daily (QD) oral inhalation
15969106|NCT03118752|Behavioral|Collaborative Care|The CC intervention will use a novel three-pronged approach to these high-risk patients. Care managers will provide centralized care coordination and specific interventions targeting: (1) the psychiatric disorders, (2) cardiac health behaviors, and (3) the cardiac illness.
15969107|NCT03118739|Drug|Verinurad 9 mg+Febuxostat 80 mg|Capsule administered orally, once daily for 24 weeks
15969108|NCT03118739|Drug|Placebo|Capsule administered orally, once daily for 24 weeks
15969109|NCT03118713|Drug|metformin|oral
15969110|NCT03118713|Drug|ipragliflozin|oral
15969111|NCT03118713|Drug|glimepiride|oral
15969112|NCT03118700|Other|Aerobic Interval Exercise|Subjects will perform an interval exercise bout on a cycle ergometer. To warm up, they will cycle at a work rate associated with 50% of their max heart rate (HR) for 10 minutes. Wattage will then increase and they will do four 4-minute intervals at a work rate associated with 90%-95% HRmax, separated by 3 minutes of active recovery at a work rate associated with 50% HRmax They will be given a 5-minute cool-down period at a work rate associated with 50% of their max HR. After the exercise, they will remain in the lab for 4 hours and their blood pressure will be measured every 10 minutes using an automated blood pressure monitor and cardiac output will be measured using the PhysioFlow. They will remain seated during this time
15969113|NCT03118700|Other|Continuous exercise|Subjects will perform a 30-minute continuous exercise bout on a cycle ergometer. To warm up, they will cycle at a work rate associated with 50% of their max heart rate (HR) for 10 minutes. Wattage will then increase and they will perform a 30-minute exercise bout at a work rate associated with 75%-80% of their max HR. They will be given a 5-minute cool-down period at a work rate associated with 50% of their max HR. After the exercise, they will remain in the lab for 4 hours and their blood pressure will be measured every 10 minutes using an automated blood pressure monitor and cardiac output will be measured using the PhysioFlow. They will remain seated during this time.
15969114|NCT03118687|Other|Biospecimen and survey collection|Blood, microbiota, surveys/questionnaires, electronic medical records.
15969115|NCT03118674|Drug|Harvoni|One capsule of Harvoni/ ledipasvir, 90 mg + sofosbuvir, 400 mg administered daily for 8, 12, or 24 weeks
15969116|NCT03118661|Other|For Step 2: Structured treatment interruption|-Accepted tool in the evaluation of immunological interventions, gene therapy, or therapeutic vaccines for the treatment of HIV infection
15969117|NCT03118661|Procedure|Peripheral blood draw|-Screening, entry for Step 1, Step 1 visit 2, entry for Step 2, weekly, week 16, monthly through week 52, week 52, quarterly through year 5, year 5, and viral relapse
15969118|NCT03118648|Diagnostic Test|Scale Action Research Arm Test (ARAT)|Measuring the functional recovery of the paretic upper limb rehabilitation outing with the scale ARAT
15969119|NCT03118635|Behavioral|Intervention|Physical activity programming in accordance with the SPARK - After School curriculum as well as engaging activities provided by local community partners. The intervention proceeded the SFSP lunch meal service, so that children received approximately three hours of physical activity programming daily.
15969120|NCT03118622|Device|Pentax|Intubation using Pentax video laryngoscope in Pentax group
15969121|NCT03118609|Other|Understanding Needs Survey|"2-hour Focus Group
~Mailed or E-mailed Survey"
15969122|NCT03118596|Device|I-gel|Fibreoptic guided tracheal intubation is going to be performed through the I-gel supraglottic airway.
15969123|NCT03118596|Device|LMA Protector|Fibreoptic guided tracheal intubation is going to be performed through the LMA Protector supraglottic airway.
15969124|NCT03118583|Dietary Supplement|300 mg/day of dietary supplement containing carrageenan|300 mg/day of dietary supplement containing carrageenan.
15969125|NCT03118570|Drug|BPS804|Intravenous infusion
15969126|NCT03118557|Other|Pilates pelvic floor strengthening|Pilates pelvic floor strengthening.
15969127|NCT03118544|Device|DyeVert System|The DyeVert System (Osprey Medical, Inc) consists of a Contrast Monitoring Wireless Display (CMW) and the DyeVert Plus Disposable Kit which is inclusive of a disposable single-use sterile Smart Syringe and DyeVert Plus Module.
15969129|NCT03118518|Device|Cryoablation|Pulmonary vein isolation via ablation with cryoballoon catheter
15969130|NCT03118518|Drug|Antiarrhythmic drug|Antiarrhythmic drug initiation
15969131|NCT03118505|Device|Infuse Bone Graft|Infuse Bone Graft + Mastergraft Strip + local bone autograft + posterior fixation
15969132|NCT03118505|Device|Medtronic DBM|Medtronic DBM + local bone autograft (and supplemented with iliac crest bone graft (ICBG), if needed) + posterior fixation
15969133|NCT03118492|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo HCT
15969134|NCT03118492|Drug|Cyclophosphamide|Given IV
15969135|NCT03118492|Drug|Fludarabine|Given IV
15969136|NCT03118492|Biological|Glycosylated Recombinant Human G-CSF AVI-014|Given IV
15969137|NCT03118492|Other|Laboratory Biomarker Analysis|Correlative studies
15969138|NCT03118492|Drug|Melphalan|Given IV
15969139|NCT03118492|Drug|Mycophenolate Mofetil|Given PO
15969140|NCT03118492|Drug|Tacrolimus|Given IV or PO
15969141|NCT03118492|Radiation|Total-Body Irradiation|Undergo TBI
15969142|NCT03118479|Drug|Anastrozole Pill|10 mg of Anastrozole to be taken daily for 3 months.
15969145|NCT03118466|Drug|Etoposide|A Drug that interfere with the action of topoisomerase enzymes (topoisomerase I and II). Topoisomerase enzymes control the manipulation of the structure of DNA necessary for replication.
15969146|NCT03118466|Drug|Cytarabine|Cytarabine is an antimetabolite antineoplastic agent that inhibits the synthesis of DNA.
15969147|NCT03118466|Drug|Lenalidomide|It may act by inhibiting the growth of new blood vessels (angiogenesis) in tumors, enhancing the status of the immune system, or decreasing cytokine and growth factor production
15969148|NCT03118466|Drug|Mitoxantrone|It interfere with cell reproduction
15969149|NCT03118453|Behavioral|Active implementation clinics|Physical therapy treatment as the physical therapist chooses
15969150|NCT03118453|Behavioral|Passive implementation clinics|Physical therapy treatment as the physical therapist chooses
15969151|NCT03118440|Procedure|zero-fluoroscopy 3D navigation|Pacemaker implantation will be performed without fluoroscopy using 3D navigation systems.
15969152|NCT03118440|Procedure|conventional x-ray navigation|Pacemaker implantation will be performed with fluoroscopy using conventional X-ray navigation.
15969153|NCT03118427|Procedure|zero-fluoroscopy 3D navigation|Pacemaker implantation will be performed without fluoroscopy using 3D navigation systems.
15969154|NCT03118427|Procedure|conventional x-ray navigation|Pacemaker implantation will be performed with fluoroscopy using conventional X-ray navigation.
15969155|NCT03118414|Other|Physical Exercise|"Participants were trained by exercise program based on their initial muscle strength and balance condition.
~They received a 30-minute exercise for 3sessions per week for 8 weeks in this study."
15969156|NCT03118414|Other|Virtual Reality|"Participants were trained with the guidance of VR system.The participants will be asked to choose 6 games from the list before each 30-minute session, and were asked to choose the games to include the upper limbs, lower limbs, and also for both strength and balance challenges instead of choosing the games that need to use only upper limbs or lower limbs, and only for strength or balance gain.
~They received a 30-minute exercise for 3sessions per week for 8 weeks in this study."
15969157|NCT03118414|Other|Brain Exercise|Brain Exercise (BE) BE stimulates the executive function, planning, concentration, visual memory and eye-hand co-ordination of the participants throughout the training.For the brain exercise, participants needed to play cognitive stimulating games; Chinese Checker, Janga and Memory Matched pair game; in the sitting position. The participants needed to paly 10 minutes for each gamed and total duration of all 3 games was about 30 minutes in each session for 3sessions per week for 8 weeks in this study.
15969158|NCT03118401|Other|Ritual of stool|During the first 4 weeks, data will be collected on an individual stool diary with usual care of the resident After randomization will start the implementation period of ritual of stool. From the stool diary: - will be determined the stool profile of each resident over 1 week and application of the ritual of stool the following week At the end of this second period, data will be collected on an individual stool diary in for 4 weeks
15969159|NCT03118401|Other|Usual practice|"During the first 4 weeks, data will be collected on an individual stool diary with usual care of the resident After randomization will start 2 weeks without data collection. Patient will be follow in usual practice.
~At the end of this second period, data will be collected on an individual stool diary in for 4 weeks"
15969160|NCT03118388|Behavioral|Social Enterprise Intervention|The SEI model was implemented in four stages: 1) Vocational skill acquisition (4 months); 2) Small business skill acquisition (4 months); 3) SEI formation and product distribution (12 months); and 4) Clinical/case-management services, (ongoing for 20 months).
15969161|NCT03118388|Behavioral|IPS|To implement the IPS at the host agency, one employment specialist, two case managers, and two clinicians were assigned the 22 available IPS cases among them at baseline. Over the 20 months, all IPS participants met individually with the employment specialist, one case manager, and one clinician at least weekly. Regarding job development in the community, the IPS employment specialist also spent about 40% of each week out in the community building relationships with new and existing employers.
15969162|NCT03118375|Device|super-power BAHA processor|The super-power BAHA processor will be provided for use at the study visit only to run different types of hearing tests, speech understanding tests in quiet, and speech understanding tests in noise. The same tests will be performed with the use of the subject's current BAHA processor for comparison.
15969163|NCT03118362|Drug|Plasmalyte|"Parenteral administration of Plasmalyte initiated immediately after inclusion at a dosage of 4 ml / kg per percentage area of skin burned for the first 24 hours after burn injury and adjusted based on hemodynamic monitoring.
~Each patient will receive this solution up to 5 days."
15969164|NCT03118362|Drug|Ringer lactate|"Parenteral administration of Ringer lactate initiated immediately after inclusion at a dosage of 4 ml / kg per percentage area of skin burned for the first 24 hours after burn injury and adjusted based on hemodynamic monitoring.
~Each patient will receive this solution up to 5 days."
15969165|NCT03118349|Drug|MVT-1075|MVT-1075 is administered in two fractions, with each administration of MVT-1075 preceded by blocking dose of MVT-5873.
15969166|NCT03118349|Drug|MVT-5873|MVT-5873 is administered intravenously as a non-radioactive blocking agent prior to administration of MVT-1075.
15969167|NCT03118336|Drug|Empagliflozin 10Mg Tab|1 tablet of 10 milligrams per bone 1 time a day during 12 weeks
15969168|NCT03118323|Other|Questionnaire|Patients are given a questionnaire with items related to personality and their willingness-to-pay for different treatment options.
15969169|NCT03118310|Behavioral|5:2 diet|Dietary intervention according to 5:2 diet during three months.
15969170|NCT03118310|Behavioral|LCHF|Dietary intervention according to LCHF diet during three months.
15969171|NCT03118310|Behavioral|Placebo diet|Placebo diet: normal dietary advice
15969172|NCT03118297|Drug|Ulipristal Acetate|Women who have bothersome bleeding with the etonogestrel implant will be randomized to receive ulipristal acetate versus placebo daily for 7 days.
15969173|NCT03118297|Drug|Placebo oral capsule|Women who have bothersome bleeding with the etonogestrel implant will be randomized to receive ulipristal acetate versus placebo daily for 7 days.
15969174|NCT03118284|Other|urine collection|
15969175|NCT03118284|Other|Blood collection|
15969176|NCT03118284|Behavioral|NRS|
15969177|NCT03118271|Device|lumbar traction|
15969178|NCT03118271|Procedure|spinal manipulation|
15969179|NCT03118271|Procedure|surgery|
15969623|NCT03115086|Drug|Cholbam|Cholbam prescribed according to the approved label.
15969180|NCT03118258|Behavioral|'Pap smear' arm|"Women are invited to participate in a preventive consultation. Doctor of the World staff provides women with information in their mother tongue and uses visuals adressing cervical cancer, its causes and consequences and ways to prevent it.
~This consultation is followed by direct patient referral for Pap smear testing in a partner health facility."
15969181|NCT03118258|Behavioral|'Self-collected vaginal swab for HPV testing + pap smear triage' arm|"Women are invited to participate in a preventive consultation. Doctor of the World staff provides women with information in their mother tongue and uses visuals adressing cervical cancer, its causes and consequences and ways to prevent it.
~This consultation is followed by patient referral for Pap smear testing in a partner health facility if the HPV-HR test is positive.
~A women who tests negative for HPV-HR can still be referred for further Pap smear testing, or can be referred for a gynaecological consultation for any other reason."
15969182|NCT03118245|Device|AuraGain|After anesthetic induction, AuraGain is inserted in children
15969183|NCT03118245|Device|I-gel|After anesthetic induction, I-gel is inserted in children
15969184|NCT03118232|Drug|Chlorhexidine gluconate (CHG)|2% no-rinse chlorhexidine gluconate (CHG) for bed bathing and 4% rinse-off CHG showering. Bathing frequency will be per routine plus admission bathing.
15969185|NCT03118232|Drug|Iodophor (10% povidone-iodine)|Nasal decolonization using topical 10% povidone-iodine nasal swabs will be applied to all residents on admission for 5 days twice daily plus every other week Monday-Friday using a twice daily regimen.
15969186|NCT03118219|Other|Positive adjustment coping intervention|see arm description
15969187|NCT03118219|Other|Brainteaser|see arm description
15969188|NCT03118206|Device|lumbar traction|
15969189|NCT03118206|Procedure|spinal manipulation|
15969190|NCT03118206|Procedure|surgery|
15969191|NCT03118193|Other|olfactive tests|olfactive tests: odor identification, odor discrimination and olfactory threshold
15969192|NCT03118193|Biological|blood test|one sample of 4mL
15969193|NCT03118193|Biological|Collection of faeces|Collection of faeces by patient at home - optional
15969194|NCT03118193|Device|Tissue Pulsatility imaging|Ultrasound exploration of brain pulsatility - optional
15969195|NCT03118180|Biological|CD19 targeted chimeric antigen receptor T cells|CD19 targeted chimeric antigen receptor T cells for refractory and relapsed B cell lymphoma
15969196|NCT03118167|Dietary Supplement|Tea polyphenols|Tea polyphenols 0.05g, 0.1g, 0.2g (starches filled up to 0.35g), edible capsule
15969197|NCT03118167|Dietary Supplement|AOB-w|Water-soluble antioxidant of bamboo leaves 0.35g, edible capsule
15969198|NCT03118167|Other|Placebo|Edible starches 0.35g, edible capsule
15969199|NCT03118167|Other|Acrylamide (Potato Chips)|Potato Chips bought from market, corresponding to acrylamide (12.6μg/kg b.w. )
15969200|NCT03118154|Other|Manual Physical Therapy|Manual Physical Therapy intervention using the Clear Passage Approach (CPA). The focus of the CPA is to deform adhesions throughout the body using a variety of manual therapy techniques and modalities.
15969201|NCT03118141|Procedure|blastocyst morphologic score|Blastocysts will be scored by Gardner morphologic criteria.
15969202|NCT03118141|Procedure|blastocyst biopsy and sequencing|Three blastocysts will be biopsied on trophectoderm, sequenced with next-generation sequencing (NGS). Euploidy will transferred one by one according to morphologic score.
15969203|NCT03118141|Procedure|freeze-all and single thawed blastocyst transfer|All blastocysts will be vitrified in fresh cycle. Single blastocyst will be thawed and transferred.
15969204|NCT03118128|Drug|Metformin|Metformin 850 mg PO three times a day plus prednisone in one 7-days cycle as pre-treatment and during the 28 days induction remission treatment, consolidation therapy and maintenance
15969205|NCT03118115|Device|Measurement of the flap bioimpedance|Measurement of the flap bioimpedance before and after clamping of the artery or the vein. For information: All patients will have the vein and the arterial section simulating venous or arterial thrombosis.
15969206|NCT03118089|Dietary Supplement|Biscuit style oral nutritional supplement|
15969207|NCT03118076|Drug|0.3% ropivacaine and 50 μg dexmedetomidine|Nerve blocks were administered with 0.3% ropivacaine and 50 μg dexmedetomidine.
15969208|NCT03118076|Drug|Ropivacaine|Nerve blocks were administered with 0.3% ropivacaine.
15969209|NCT03118063|Diagnostic Test|Evaluation of pain by algometry|Assessment of the level of pain and function of asymptomatic individuals, compared with the time that they evolve with acute and chronic low back pain
15969210|NCT03118050|Behavioral|Resistance exercise training|Supervised resistance exercise training, 3 times a week for 3 months
15969211|NCT03118050|Behavioral|Bed rest|Bed rest for 5 days, followed by standard rehabilitation for 2 days
15969212|NCT03118050|Behavioral|Intensive physical therapy|Intensive weight bearing PT, daily, during bed rest
15969213|NCT03118037|Device|Sonata System|Transcervical access for radiofrequency ablation of uterine fibroids
15969214|NCT03118024|Drug|Crystalloid Solutions|crystalloid restrictive anesthesia protocol
15969215|NCT03118024|Drug|Catecholamines|catecholamine restrictive anesthesia protocol
15969216|NCT03118011|Other|No smoking|No smoking
15969217|NCT03118011|Other|Smoking|Ability to go out to smoke
15969218|NCT03117998|Biological|REMD-477|Administered as repeated SC doses in subjects with Type 1 Diabetes
15969219|NCT03117998|Biological|Placebo Comparator|Administered as a repeated SC doses in subjects with Type 1 Diabetes
15969220|NCT03117985|Other|no drug|Stopping antiretroviral therapy
15969221|NCT03117972|Drug|FOLFOXIRI|12 cycles
15969222|NCT03117972|Drug|FOLFOX|12 cycles
15969223|NCT03117972|Drug|FOLFIRI|12 cycles
15969224|NCT03117972|Drug|Bevacizumab|12 cycles
15969225|NCT03117972|Drug|LV5FU2|Maintenance chemotherapy
15969226|NCT03117972|Drug|Capecitabine|Maintenance chemotherapy
15969227|NCT03117959|Device|Stryker ShapeMatch Technology|Will use this patient-specific guide for alignment with Stryker Triathlon Custom Fit Knee.
15969228|NCT03117959|Device|Stryker Triathlon Custom Fit Knee|
15969229|NCT03117946|Other|Biological samples|blood and tumor tissue sample
15969230|NCT03117933|Drug|Olaparib|Tablet, 100mg and 150mg
15969231|NCT03117933|Drug|Cediranib|Tablet 15mg and 20mg
15969232|NCT03117933|Drug|Paclitaxel|Intravenous (IV)
15969624|NCT03115073|Drug|Candiplus|Administration of Candiplus
15969233|NCT03117920|Drug|Minnelide|Minnelide will be administered at the dose of 0.67 mg/m2 as a 30 min infusion intravenously daily on days 1-21 of each cycle followed by a 7 day rest period (days 22-28).
15969234|NCT03117894|Drug|Ropivacaine 5 mg/ml, 35 ml|Regional Anesthesia. The deposition of local anesthetics in proximity of nerves with the aim of blocking nerve transmission. This is used to block pain as an alternative to systemic treatment of pain.
15969235|NCT03117894|Drug|Remifentanil 50 microg/ml|The intravenous administration of anesthetics aiming to induce analgesia (part of the general anesthesia). No fixed dose, administered in relation to the study participants need at the moment.
15969236|NCT03117894|Drug|Betamethason 4 mg|Are meant to decrease the risk of so called postoperative nausea and vomiting (PONV). Administered preoperatively.
15969237|NCT03117894|Drug|Paracetamol 1,5 g|Administered preoperatively to prevent pain postoperatively.
15969238|NCT03117894|Drug|Propofol|The intravenous administration of anesthetics aiming to induce sleep (part of the general anesthesia). No fixed dose, administered in relation to the study participants need at the moment.
15969239|NCT03117894|Drug|Arcoxia, 120 mg|Administered preoperatively to prevent pain postoperatively.
15969240|NCT03117894|Drug|Ondansetron 4 mg|Are meant to decrease the risk of so called postoperative nausea and vomiting (PONV). Administered peroperative.
15969241|NCT03117894|Drug|Morphine|Administered peroperative, at the end of the surgery, before awakening the study participant. The aim is to prevent pain.
15969242|NCT03117881|Behavioral|DirectCAM|The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at a clinic with a therapist. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
15969243|NCT03117881|Behavioral|TeleCAM|The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks at home via videos. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using the videos.
15969244|NCT03117881|Behavioral|rDirectCAM|The intervention consists of a 60-minute Complementary Alternative Medicine (CAM) program that includes yoga, Pilates and dual-functioning exercises, which is delivered 2 times per week for the first 8 weeks and 1 time per week for the following 4 weeks by a therapist via videoconferencing technology. At the end of week 12, participants will be asked to continue the program in their home for up to 1 year post-intervention using handouts.
15969245|NCT03117868|Other|Study of mortality at 6 months|The objective is to provide strong arguments for establishing a dynamic of collective care for patients suffering from an EFSF
15969246|NCT03117855|Drug|Capecitabine|Given PO
15969247|NCT03117855|Other|Laboratory Biomarker Analysis|Correlative studies
15969248|NCT03117855|Radiation|Radioembolization|Undergo yttrium Y-90 radioembolization
15969249|NCT03117842|Other|Automated text and voice messages|Participants will receive 3x weekly SMS or VM theory-based behavioral messages that will be designed to enhance and increase utilization of existing HIV and SRH services by reminding clients about safe sex methods available to them and providing a conduit for additional support. Participants will also be reminded in each message that they can talk to a peer counselor at any time by responding to the message. Participants who indicate they would like to talk to a counselor will receive a call from a Mobile Link community partner. The counselor will provide individualized information on HIV prevention and care and advice.
15969250|NCT03117829|Behavioral|Diet and Exercise|Diet and Exercise Study to Improve Brain Blood Flow
15969253|NCT03117790|Drug|Dexmedetomidine|Morphine (0.5 mg/ml, in a total volume of 160 ml) is used for patient-controlled analgesia. Dexmedetomidine (200 ug) is added to the formula of patient-controlled analgesia. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with patient-controlled bolus of 2 ml each time and a lockout time from 6 to 8 minutes.
15969254|NCT03117790|Drug|Placebo|Morphine (0.5 mg/ml, in a total volume of 160 ml) is used for patient-controlled analgesia. Placebo (normal saline) is added to the formula of patient-controlled analgesia. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with patient-controlled bolus of 2 ml each time and a lockout time from 6 to 8 minutes.
15969255|NCT03117777|Behavioral|group cognitive behavioral therapy for insomnia|cognitive behavioral therapy for insomnia delivered in group setting for older adults
15969256|NCT03117764|Device|Microfet Dynamometer|"To evaluate muscular strength, the investigators will measure quadriceps force at the beginning of the cure and at the end with a functional test, the 1-minute Sit-to-Stand test, and a maximal isometric force test, with the Microfet2dynamometer. Those tests are not invasive and easy to realise.
~The investigators will estimate the physical activity of the patients with an accelerometer that they will each carry 72 hours, during the cure.
~Patients who undergo their cure at the hospital will follow a specific training program with the physiotherapist."
15969257|NCT03117764|Behavioral|1 minute sit to stand test|"To evaluate muscular strength, the investigators will measure quadriceps force at the beginning of the cure and at the end with a functional test, the 1-minute Sit-to-Stand test, and a maximal isometric force test, with the Microfet2dynamometer. Those tests are not invasive and easy to realise.
~The investigators will estimate the physical activity of the patients with an accelerometer that they will each carry 72 hours, during the cure.
~Patients who undergo their cure at the hospital will follow a specific training program with the physiotherapist."
15969340|NCT03117283|Procedure|Laparoscopic D2 radical total gastrectomy with bursectomy using a left outside bursa omentalis approach|Patients with advanced posterior gastric wall cancer including in the laparoscopic total gastrectomy (LTG) with bursectomy group will undergo laparoscopic D2 radical total gastrectomy with bursectomy using a left outside bursa omentalis approach.
15969625|NCT03115073|Drug|Clotrimazole|Administration of Clotrimazole
15969258|NCT03117764|Device|Accelerometer|"To evaluate muscular strength, the investigators will measure quadriceps force at the beginning of the cure and at the end with a functional test, the 1-minute Sit-to-Stand test, and a maximal isometric force test, with the Microfet2dynamometer. Those tests are not invasive and easy to realise.
~The investigators will estimate the physical activity of the patients with an accelerometer that they will each carry 72 hours, during the cure.
~Patients who undergo their cure at the hospital will follow a specific training program with the physiotherapist."
15969259|NCT03117751|Drug|Prednisone|Given orally (PO).
15969260|NCT03117751|Drug|Vincristine|Given intravenously (IV).
15969261|NCT03117751|Drug|Daunorubicin|Given IV.
15969262|NCT03117751|Drug|Pegaspargase|Given IV or intramuscularly (IM) .
15969263|NCT03117751|Drug|Erwinase®|To be used in case of hypersensitivity or intolerance to Pegaspargase. Given IV or intramuscularly (IM).
15969264|NCT03117751|Drug|Cyclophosphamide|Given IV.
15969265|NCT03117751|Drug|Cytarabine|Given IV or by subcutaneous injection (SQ).
15969266|NCT03117751|Drug|Mercaptopurine|Given PO.
15969267|NCT03117751|Drug|Dasatinib|Given PO.
15969268|NCT03117751|Drug|Methotrexate|Given IV.
15969269|NCT03117751|Drug|Blinatumomab|Given IV.
15969270|NCT03117751|Drug|Ruxolitinib|Given PO.
15969271|NCT03117751|Drug|Bortezomib|Given IV or subcutaneously (SQ).
15969272|NCT03117751|Drug|Dexamethasone|Given PO.
15969273|NCT03117751|Drug|Doxorubicin|Given IV.
15969274|NCT03117751|Drug|Etoposide|Given IV.
15969275|NCT03117751|Drug|Clofarabine|Given IV.
15969276|NCT03117751|Drug|Vorinostat|Given PO.
15969277|NCT03117751|Drug|Idarubicin|Given IV.
15969278|NCT03117751|Drug|Nelarabine|Given IV.
15969279|NCT03117751|Drug|Thioguanine|Participants with mercaptopurine-related pancreatitis. Given PO.
15969280|NCT03117738|Drug|AstroStem|Autologous adipose tissue derived mesenchymal stem cells (AdMSC)
15969281|NCT03117738|Other|Placebo-Control|Saline with 30% auto-serum
15969282|NCT03117725|Drug|Melatonin adminstration|The drug, melatonin will be taken every night from the time of COH to the date of oocyte retrieval. The method of administration is as follows: Melatonin 2mg once a day, 1 to 2 hours before bedtime for about 2 weeks until the date of oocyte retrieval.
15969283|NCT03117725|Drug|placebo administration|the drug, placebo pill will be taken every night from the time of COH to the date of oocyte retrieval. The method of administration is as follows: placebo pill once a day, 1 to 2 hours before bedtime for about 2 weeks until the date of oocyte retrieval.
15969284|NCT03117712|Diagnostic Test|Delirium Scores|"Confusion Assessment method for the ICU (CAM-ICU) and
~The Intensive Care Delirium Screening Checklist (ICDSC)
~Delirium Scores will be measured at the following timepoints:
~Postoperative day (POD) 1
~POD 2
~POD 5"
15969285|NCT03117712|Diagnostic Test|Carotis duplex sonography|"Carotis duplex sonography for perfusion flow will be evaluated at the following timepoints:
~Before induction of anaesthesia
~Before going on cardiopulmonary bypass (CBP)
~During CPB, 5 min after aortic cross clamping
~After CPB
~24 hours after CPB"
15969286|NCT03117712|Diagnostic Test|TCD for detection of HITS|"Transcranial Doppler ultrasound (TCD) for detection and differentiation of high-intensity transient signals (HITS) in both middle cerebral arteries (MCAs) into artefacts, solid, and gaseous cerebral microemboli (CME) will be performed at the following timepoints:
~During cannulation of the ascending aorta
~After aortic cross-clamp
~After opening of the aortic cross-clamp
~During decannulation"
15969287|NCT03117699|Device|New device for seated-standing passages|"Phase 1 : The subject perform different seated-standing passages (see Arm)
~Phase 2 : After being seated, the subject performs a course comprising:
~A standing pass from sitting on a chair
~A straight line movement
~A succession of left and right turns
~An upward and downward travel of less than 1%.
~Standard doorway
~Standing on the toilet
~A sitting pass from the toilet
~One way to a bed
~A sitting pass on the bed
~A passenger seat sitting upright from the bed
~A return to the starting point
~A sitting pass on the starting chair"
15969288|NCT03117686|Diagnostic Test|lung ultrasound|"lung ultrasound with positive B-line pattern in patients after lung transplantations and healthy volunteers at sea level and high altitude (4600 m) at Mountb Kilimanjaro"
15969289|NCT03117673|Other|transesophageal echocardiography measurements|transesophageal echocardiography will be done routinely during the procedure. We will do additional measurements of the maximal TR velocity
15969290|NCT03117660|Drug|Vitamin A|vitamin A daily X3-4 weeks
15969291|NCT03117647|Procedure|Mansoura-VV compression suture|two compression suture both are v shaped apex of each suture placed 2 cm below suture line of C.S and 3 cm from the lateral border of the uterus on the right and left side
15969292|NCT03117634|Drug|Treat and Extend with Aflibercept 2mg|Drug treatment regime which allows extension of treatment interval based on disease activity
15969293|NCT03117634|Drug|Fixed Dosing with Aflibercept 2mg|Fixed 8 weekly dosing regime throughout the study duration
15969294|NCT03117608|Biological|injection of autologous micro-fragmented adipose tissue (aMAT)|adipose tissue will be obtained from abdominal region or buttocks and aMAT, and processed with Lipogems® technology.
15969295|NCT03117608|Biological|injection of Platelet-rich Plasma (PRP)|injection of platelet-rich plasma
15969296|NCT03117595|Drug|Bupivacaine-fentanyl|Dosages as previously written
15969297|NCT03117595|Drug|Bupivacaine-fentanyl morphine|Dosage as previously written
15969298|NCT03117582|Other|Stool specimen|"The following stool specimen will be collected for this study:
~4, 3mL stool specimen from patient
~1, 25mL stool aliquot from donor"
15969299|NCT03117569|Drug|glecaprevir (300mg)/pibrentasvir (120mg)|glecaprevir (300mg)/pibrentasvir (120mg) for 8 weeks
15969300|NCT03117556|Procedure|Bilateral Thoracoscopic Splanchnicectomy|BTS will be performed on all patients under general endotracheal anesthesia. Patients will be placed in the prone position. A 5 mm trocar should be placed at the inferior scapular apex on the patient's left side. After confirmation of trocar placement with a 30 degree 5 mm thoracoscope, a second trocar will be placed two intercostal spaces below and two cm medial to the first trocar. After the splanchnic nerves are identified inferior and medial to the sympathetic trunk, the pleura will be incised on both sides of each of the nerves. Skin incisions are then closed and the procedure will then be repeated on the patient's right side.
15969428|NCT03116672|Drug|One dose Diclofenac|Administration of diclofenac, (Diclofenaco) 15 minutes before the clinical procedure.
15969301|NCT03117530|Drug|Minocycline|Following initial baseline PET-CT imaging and clinical evaluation, adults with ASD will undergo a 12- week open-label treatment trial of minocycline to be conducted at UCLA under supervision of the UCLA IRB. During weeks 1-6, ASD subjects will be treated with 50 mg minocycline twice daily (low dose). From weeks 7-12, dosing will be increased to 100mg twice daily (typical clinical dosage). Every two weeks during this phase, a treating clinician will measure vital signs, assess safety, record adverse effects, and monitor compliance. Compliance will be obtained as an index of tolerability and will assessed through weekly medication diaries and pill counts.
15969302|NCT03117517|Drug|Metformin|Metformin (1000 mg)
15969303|NCT03117517|Drug|Metformin, Pioglitazone|Metformin (1000 mg) Pioglitazone (30 mg)
15969304|NCT03117504|Other|questionnaire|a questionnaire is given to each woman to determine the urinary incontinence and it's impact on quality of life.
15969305|NCT03117491|Procedure|GGNB injections|The patients received two GGNB injections of 1.8 mL 2% lidocaine with 1:100,000 epinephrine
15969306|NCT03117491|Procedure|IANB injections|The patients received two IANB injections of 1.8 mL 2% lidocaine with 1:100,000 epinephrine
15969307|NCT03117491|Procedure|GGNB + IANB injections|The patients received one GGNB injection plus one IANB injection of 1.8 mL 2% lidocaine with 1:100,000 epinephrine
15969308|NCT03117478|Other|Magneto-encephalography (MEG)|Magneto-encephalography
15969309|NCT03117478|Other|Electro-encephalography (EEG)|Electro-encephalography
15969310|NCT03117478|Other|Functional Magnetic Resonance Imaging (fMRI)|Functional Magnetic Resonance Imaging
15969311|NCT03117478|Other|Anatomical Magnetic Resonance Imaging (aMRI)|Anatomical Magnetic Resonance Imaging
15969312|NCT03117478|Other|Meditation|Meditation
15969313|NCT03117465|Other|the experimental group|Stroke hemiplegia patients are randomly assigned to the experimental group (scalp acupuncture + low frequency repetitive transcranial magnetic stimulation + routine rehabilitation treatment). All patients in the day of inpatient and the fourteenth day received DTI magnetic resonance examination twice to study the change in white matter fiber microstructure.
15969314|NCT03117465|Other|the control group|Stroke hemiplegia patients are randomly assigned to the control group (scalp acupuncture + routine rehabilitation treatment). All patients in the day of inpatient and the fourteenth day received DTI magnetic resonance examination twice to study the change in white matter fiber microstructure.
15969315|NCT03117452|Behavioral|Visual Training|The computerized visual training (VT) program that is being evaluated was developed by Aaron Seitz, who is a co-investigator on this project; it includes 1) ULTIMEYES, which targets broad-based visual functions, including low-level processes (e.g., visual acuity, contrast sensitivity), and 2) visual perceptual organization exercises, which target mid-level visual processes. Both elements of the program also involve higher-level visual functions, such as visual search and visual attention.
15969316|NCT03117439|Other|duration of antifungal therapy|Patients in the study group will stop antifungals in presence of a negative result of Beta Glucan Test
15969317|NCT03117426|Device|SYMFONY IOL|IOL for presbyopic treatment in patients undergoing cataract surgery. EDOF IOL.
15969318|NCT03117426|Device|AT LISA tri 839MP IOL|IOL for presbyopic treatment in patients undergoing cataract surgery. Trifocal IOL
15969319|NCT03117413|Other|Positron emission tomography scan|"Binaural hearing assessments: speech recognition in noise and sound source localization
~Voice perception assessment: voice/non-voice discrimination task, free categorization task
~Positron emission tomography examinations under ecological auditory stimuli (voice/non-voice discrimination task)"
15969320|NCT03117387|Other|no intervention|This study contains no interventions
15969321|NCT03117374|Behavioral|Team Nutriathlon intervention|8 wk web-based nutrition intervention program aimed at increasing the consumption of fruits, vegetables and dairy products.
15969322|NCT03117361|Drug|plitidepsin|Patients received plitidepsin as a 3-hour i.v. infusion at a dose of 5 mg/m2 on Days 1 and 15 every Four Weeks.
15969323|NCT03117361|Drug|Bortezomib|BTZ as a 3-5 second bolus s.c. injection at a dose of 1.3 mg/m2 on Days 1, 4, 8 and 11 every four weeks
15969324|NCT03117361|Drug|Dexamethasone|DXM orally at a dose of 40 mg/day on Days 1, 8, 15 and 22 every four weeks
15969325|NCT03117348|Other|Enteral nutrition|Patients in Gradual Goal-dose EN group will receive increased calories gradually by EN and will reach the 80% of target energy by EN at day 8 while patients in immediate Goal-dose EN group will receive 100% of target energy by EN at day 3 after abdominal surgery. Both of the two group will receive EN for 5 days except 80% of target energy delivered by oral feeding or patients are discharged from hospital, whichever arrives first.
15969326|NCT03117335|Drug|Placebos|"Drug 1:
~Placebo(Sodium Chloride Injection),7.5mg/m2 on d1-d14 in each 21-day cycle（stop interventing until the disease progress）
~Drug 2:
~Vinorelbine-Cisplatin:
~Vinorelbine, 25mg/m2, iv, on d1 and d8 in each 21-day cycle (no more than 4 cycles); Cisplatin,75mg/m2, iv, on d1 in each 21-day cycle(no more than 4 cycles)"
15969327|NCT03117335|Drug|Sulijia|"Drug 1:
~Sulijia(Recombinant Endostatin Injection) Sulijia, 7.5mg/m2 on d1-d14 in each 21-day cycle（stop interventing until the disease progress）
~Drug 2:
~Vinorelbine-Cisplatin:
~Vinorelbine, 25mg/m2, iv, on d1 and d8 in each 21-day cycle (no more than 4 cycles); Cisplatin,75mg/m2, iv, on d1 in each 21-day cycle(no more than 4 cycles)"
15969328|NCT03117322|Biological|agave inulin|Duration: four weeks Dosage: powder 4 g/d
15969329|NCT03117322|Biological|Lactobacillus reuteri DSM 17938|Duration: four weeks Dosage: 5 drops/d
15969330|NCT03117322|Other|maltodextrin|Duration: four weeks Dosage: powder 4 g/d
15969331|NCT03117322|Other|Oil mix (medium chain triglycerides and sunflower oil)|Duration: four weeks Dosage: 5 drops/d
15969336|NCT03117296|Other|Post procedure daily PT and OT|PT evaluation and treatment on post procedure day zero: Nurses mobility patient using egress testing one time
15969337|NCT03117296|Other|PT post procedure|post procedure day one: PT and OT assessment, education and intervention.
15969338|NCT03117296|Other|OT post procedure|PT and OT Daily until goals met or patient discharge.
15969783|NCT03113825|Drug|AVB-620|AVB-620 will be administered IV before the surgical procedure.
15969341|NCT03117283|Procedure|Laparoscopic D2 radical total gastrectomy without bursectomy|Patients who are included in the laparoscopic total gastrectomy (LTG) without bursectomy group will undergo laparoscopic D2 radical total gastrectomy without bursectomy in a conventional manner.
15969342|NCT03117270|Drug|filgotinib|one filgotinib oral tablet q.d.
15969343|NCT03117270|Drug|Placebo Oral Tablet|one placebo oral tablet q.d.
15969344|NCT03117257|Drug|Lobaplatin|Device: Chrono-chemotherapy Drug: induction Chrono-chemotherapy Drug: Lobaplatin chrono-chemotherapy Radiation: intensity-modulated radiation therapy
15969345|NCT03117257|Drug|Cisplatin|Device: Chrono-chemotherapy Drug: induction Chrono-chemotherapy Drug: cisplatin chrono-chemotherapy Radiation: intensity-modulated radiation therapy
15969346|NCT03117244|Other|Exercise for Foot Strengthening|Stabilization exercises of the longitudinal arch of the foot
15969347|NCT03117244|Other|Exercise for Foot Strengthening and Electrostimulation|Exercise for the Strengthening of the Foot associated with Electrostimulation
15969348|NCT03117231|Device|Active Transcranial Direct Current Stimulation (tDCS)|Subjects will undergo 15 sessions of tDCS stimulation, 1x per day at 20 minutes per session, of up to 2mA. During active stimulation, the current will be active for the full 20 minutes.
15969349|NCT03117231|Device|Sham Transcranial Direct Current Stimulation (tDCS)|Subjects will undergo 15 sessions of tDCS stimulation, 1x per day at 20 minutes per session, of up to 2mA. However, during sham stimulation (placebo) the current will not be active for the full 20 minutes
15969350|NCT03117218|Diagnostic Test|Coronary MR angiography|Quantitative analysis of coronary MR angiogram
15969351|NCT03117205|Other|Application of Kinesio Taping®|The technique was applied following the methods described in the original method for patellofemoral instability
15969352|NCT03117205|Other|Kinesio Taping® placebo application|Simulation of the application of the Kinesio Taping® technique.
15969353|NCT03117192|Drug|Zinc Sulfate|Zinc supplementation in syrup form
15969354|NCT03117192|Drug|Sucrose Syrup|Sucrose as placebo, with same taste and consistency as zinc
15969355|NCT03117179|Other|Discharge from patient after consultation in emergency department|Discharge from patient after consultation in emergency department
15969356|NCT03117166|Drug|lidocaine|A one time bolus of lidocaine 0.5 mg/kg iv will be administered just prior to IV propofol injection,then successful defibrillation will be ascertained
15969357|NCT03117166|Drug|Placebo|A control group will get an IV bolus of 0.9% NS just prior to IV bolus of propofol, then successful defibrillation will be ascertained
15969358|NCT03117153|Other|DA-5502 liquid toothpaste|6 weeks study, brush three times daily, liquid toothpaste
15969359|NCT03117153|Other|placebo|same flavor solution, brush three times daily
15969360|NCT03117140|Drug|Ropivacaine 0.75%|Only ropivacaine 0.75% is administered for this arm of the interscalene block
15969361|NCT03117140|Drug|Ropivacaine 0.75% + 300 mcg Buprenorphine|Ropivacaine 0.75% + 300 mcg Buprenorphine is administered for this arm of the interscalene block
15969362|NCT03117140|Drug|Ropivacaine 0.75% + 75 mcg clonidine|Ropivacaine 0.75% + 75 mcg Clonidine is administered for this arm of the interscalene block
15969363|NCT03117140|Drug|Ropivacaine 0.75% + 8 mg dexamethasone|Ropivacaine 0.75% + 8 mg Dexamethasone is administered for this arm of the interscalene block
15969364|NCT03117127|Behavioral|Resistance Exercise|Participants will perform leg extension and leg press immediately prior to ingestion of whole eggs or egg whites
15969365|NCT03117127|Other|Whole Eggs|Participants will ingestion whole eggs immediately after resistance exercise
15969366|NCT03117127|Other|Egg Whites|Participants will ingestion whole eggs immediately after resistance exercise
15969367|NCT03117114|Device|Endocuff Vision assisted polypectomy|EVD mounted to the tip of the endoscope, therefore EVD assisted polypectomy
15969368|NCT03117114|Other|Standard polypectomy|Absence of an EVD, standard polypectomy
15969369|NCT03117101|Drug|Lucitanib|
15969370|NCT03117088|Other|Checklist ISBAR3|"Checklist ISBAR 3
~Use of an online based checklist for handovers with the following items:
~Identification Situation Background Assessment Recommendation Read- back Risk
~Established Checklist as communication tool"
15969371|NCT03117088|Other|Checklist VICUR|"Checklist Vicur
~Use of an online based alternative checklist for handovers with the following items:
~Vaccination status Insurance status Contact person Utilisation Rehabilitation Organ donor? Patient decree?
~alternative checklist missing communication tool"
15969372|NCT03117075|Device|"using device for scoring pain scale, named ANAPA®"|wearable device for scoring pain scale
15969373|NCT03117062|Other|occlusal reduction|relief of occlusion following endodontic treatment
15969374|NCT03117049|Drug|ONO-4538|360 mg solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
15969375|NCT03117049|Drug|Carboplatin|Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
15969376|NCT03117049|Drug|Paclitaxel|Carboplatin at AUC 6 and Paclitaxel at 200 mg/m2 intravenously in every 3 weeks for up to 4 cycles and if deemed safe, Carboplatin and Paclitaxel may continue for up to a maximum of 6 cycles until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
15969377|NCT03117049|Drug|Bevacizumab|Bevacizumab at 15 mg/kg intravenously in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
15969378|NCT03117049|Drug|Placebo|Placebo solution intravenously for 30 min in every 3 weeks until RECIST 1.1 defined PD, unacceptable toxicity, or withdrawal of consent.
15969379|NCT03117036|Drug|Chemotherapy|Systemic chemotherapy with curative intent
15969380|NCT03117023|Drug|dexmedetomidine|sufentanil 0.05ug/kh/h + dexmedetomidine 0.1ug/kg/h for 48h after surgery
15969381|NCT03117010|Drug|Steroids|High dose dexamethasone 20 mg PO or IV
15969382|NCT03117010|Drug|Etoposide|Etoposide 150mg/BSA
15969383|NCT03116997|Drug|Neostigmine+glycopyrrolate|At the conclusion of surgery neuromuscular blockade reversed with neostigmine/glycopyrrolate
15969384|NCT03116997|Drug|Sugammadex|At the conclusion of surgery neuromuscular blockade reversed with sugammadex
15969429|NCT03116672|Drug|Placebo oral capsule|Administration of Placebo, 15 minutes before the clinical procedure.
15969430|NCT03116659|Drug|Doxycycline|Doxycycline 100 mg PO BID x 14 days
15969385|NCT03116984|Procedure|Transcatheter arterial chemoembolization|Transcatheter arterial chemoembolization (TACE) is performed via an injection into the hepatic artery of agents by puncturing the common femoral artery.Adriamycin(30 to 60 mg) is considered as basic chemotherapy drugs in the process of transcatheter endovascular perfusion. The dose of lipiodol was determined by diameter and blood supply type of HCC, generally 5-20ml, and no more than 30ml once.
15969386|NCT03116984|Radiation|External- beam radiotherapy|We have reported a series of retrospective clinical trials in which transarterial chemoembolization (TACE) combined with external- beam radiotherapy (EBRT) was a better treatment method than TACE alone for unresectable HCC in the same period and organization, no matter in aspects of the regression rate of carcinoma or survival.Patients who were randomized to the EBRT 3-5 weeks after the completion 2 times TACE.
15969387|NCT03116971|Drug|M3814|Participants received M3814 PiC or hot melt extrusion (HME) tablet orally once daily in combination with etoposide (intravenously) and cisplatin for 6 cycles with each cycle lasting 3 weeks (21 days).
15969388|NCT03116971|Drug|Cisplatin|Cisplatin 75 milligram per square meter (mg/m^2) was administered over a 60-minute intravenous infusion on Day 1.
15969389|NCT03116971|Drug|Etoposide|Etoposide 100 mg/m^2 over a 60 minute IV infusion on Days 1-3 was administered for 6 cycles with each cycle lasting 3 weeks (21 days).
15969390|NCT03116958|Device|CPAP + Standard care|CPAP device + Standard management at Sleep Unit. According to Spanish Respiratory Society guidelines during 6 months
15969391|NCT03116958|Device|CPAP + Telemedicine|CPAP+ telemedicine approach. Patients followed up at Sleep Unit according to Spanish Respiratory Society guidelines during 6 months.
15969392|NCT03116945|Drug|68Gallium Citrate|Procedure: PET/CT Imaging
15969393|NCT03116932|Behavioral|PrEP knowledge and acceptability questionnaire|This questionnaire consists of 187 items and evaluates socio-demographic variables, sex conducts, PrEP knowledge and PrEP acceptability.
15969394|NCT03116919|Other|Potato|Participants will be given an extra serving of potato a day
15969395|NCT03116919|Other|Non-starchy vegetable|Participants will be given an extra serving of a non-starchy vegetable
15969396|NCT03116906|Drug|BI 685509|to be given for a total of up to 15 days
15969397|NCT03116906|Drug|Placebo|to be given for a total of up to 15 days
15969398|NCT03116893|Drug|BI 685509 After Standardised Breakfast|High-fat high calorie breakfast
15969399|NCT03116893|Drug|Itraconazole|Administration of itraconazole together with BI 685509
15969400|NCT03116893|Drug|Rifampin|Administration of rifampicin together with BI 685509
15969401|NCT03116893|Drug|BI 685509 Fasted Conditions|BI 685509, given alone
15969402|NCT03116880|Procedure|Endovascular aortic repair|Endovascular aortic repair
15969403|NCT03116867|Other|sonosalpingography|transvaginal ultrasound with saline infusion
15969404|NCT03116841|Drug|Vonoprazan|Vonoprazan 20 mg
15969405|NCT03116828|Drug|Eslicarbazepine acetate|eslicarbazepine acetate tablets, taken once daily. Subjects begin 2-week Titration Phase starting on Day 1 (Week 1), by initiating treatment with ESL 400 mg/day. Subjects titrate to minimum dose of 800 mg/day for the 24-week Maintenance Phase beginning at Week 3. In the Maintenance Phase, subjects may titrate in weekly increments of 400 mg/day as medically indicated at the discretion of Investigator up to a maximum dose of 1200 mg/day (Canadian sites) or 1600 mg/day (US sites)
15969406|NCT03116828|Drug|Eslicarbazepine Acetate|eslicarbazepine acetate acetate tablets, taken once daily. Subjects begin 2-week Titration Phase starting on Day 1 (Week 1), by initiating treatment with ESL 400 mg/day. Subjects titrate to minimum dose of 800 mg/day for the 24-week Maintenance Phase beginning at Week 3. In the Maintenance Phase, subjects may titrate in weekly increments of 400 mg/day as medically indicated at the discretion of Investigator up to a maximum dose of 1200 mg/day (Canadian sites) or 1600 mg/day (US sites)
15969407|NCT03116815|Other|Direct input of home blood pressure readings via MyChart|Participants will record home blood pressure readings directly into the electronic health record via the MyChart application
15969408|NCT03116802|Drug|Stamaril (live attenuated yellow fever vaccine)|They will receive a single dose of 0.5ml of Stamaril (live attenuated yellow fever vaccine)
15969409|NCT03116789|Dietary Supplement|probiotics|Two capsules for daily
15969410|NCT03116776|Procedure|Walnut Shell Glasses Moxibustion|Participants in experimental group will receive 12 sessions of walnut shell glasses moxibustion, each for 30 minutes,3 times per week, and administered over 4 weeks.
15969411|NCT03116776|Drug|Sodium hyaluronate eye drops|One drop for each eye, four times per day for over 4 weeks.
15969412|NCT03116763|Behavioral|iPeer2Peer Mentorship|10 sessions of 20-30 minute Skype calls conducted over 5-12 weeks.
15969413|NCT03116763|Other|Active Comparator: Control Group|The control group will receive standard care but without the iPeer2Peer program.
15969414|NCT03116737|Drug|Benzocaine Otic Solution|
15969415|NCT03116737|Drug|Placebo|
15969416|NCT03116724|Procedure|central venous catheterization through Rt. IJV|"insertion at the intersection of the cricoid cartilage level and the triangular point where the sternal head of the SCM muscle meets the clavicular head
~placement of the tip of the catheter 2 cm away from the junction between right atrium and superior vena cava using TEE
~measurement of the depth of the catheter at insertion point"
15969417|NCT03116711|Other|Positive CIQ plus High Carbohydrate Diet|Positive Carbohydrate Intolerance Questionnaire plus High Carbohydrate Diet
15969418|NCT03116711|Other|Positive CIQ plus High Protein Diet|Positive Carbohydrate Intolerance Questionnaire plus High Protein Diet
15969419|NCT03116711|Other|Negative CIQ plus High Carbohydrate Diet|Negative Carbohydrate Intolerance Questionnaire plus High Carbohydrate Diet
15969420|NCT03116711|Other|Negative CIQ plus High Protein Diet|Negative Carbohydrate Intolerance Questionnaire plus High Protein Diet
15969421|NCT03116698|Drug|Low dose DFD07 once daily|Low dose DFD07 once daily
15969422|NCT03116698|Drug|High dose DFD07 once daily|High dose DFD07 once daily
15969423|NCT03116698|Drug|High dose DFD07 twice daily|High dose DFD07 twice daily
15969424|NCT03116698|Drug|Placebo twice daily|Placebo twice daily
15969425|NCT03116685|Biological|Oxabact OC5 - Oxalobacter formigenes HC-1|Active study drug
15969426|NCT03116685|Other|Placebo|Placebo
15969427|NCT03116672|Drug|one dose ketorolac 10 mg|Administration of ketorolac 10mg, (Dolac) 15 minutes before the clinical procedure.
15969431|NCT03116659|Drug|Imiquimod|up to 2 packs 3/ week x 28 days
15969432|NCT03116646|Diagnostic Test|Chewing evaluation|Children with chewing disorders will be recruited. Each child is required to bite and chew a standardized biscuit for chewing evaluation. The chewing function of each child is scored with the Karaduman Chewing Performance Scale by a physical therapist. Then, the chewing function of each child is also scored with the Karaduman Chewing Performance Scale-Family report by their families.
15969433|NCT03116620|Other|Chewing evaluation|Children with neuromuscular disorders (NMD) will be participated. Children will be asked to chew a standardized biscuit while video recording. Two physical therapists will assess all video recordings independently and score each video according to the KCPS. The correlation between the KCPS scores of two therapists will be used for interobserver reliability. One therapist will rescore the recordings after an interval of 2 weeks for intraobserver reliability.
15969434|NCT03116607|Other|patient education/ recommendations to the health team|The intervention group will receive a Pharmaceutical Intervention Program during their stay in the Service and discharge that includes an analysis of the therapy indicated by the physician, evaluating the safer alternatives for the type of patient and the special conditions of their pathology, with emphasis on Assessments of effectiveness, safety and tolerability of medication, drug interactions, possible adverse events, dose adjustments as necessary according to patient conditions; Verification that the administration is optimal, including the choice of the best route for this and the time in which the drugs are infused to the patient.
15969435|NCT03116594|Biological|NBP608|Preparation of Oka/SK strain of live, attenuated zoster virus
15969436|NCT03116594|Biological|Zostavax|Preparation of Oka/Merck strain of live, attenuated zoster virus
15969437|NCT03116581|Other|Behavior|"Random-dots tasks: dots appear and move, most have a random trajectory but a given proportion of them move coherently to the same direction.
~Vicarious reward Each trial begins with a cue, showing 'me' or 'him' and filled rectangle filled proportionally to the payoff. The cue and the square are depicted in yellow (oneself) or blue (other), depending on the beneficiary. The moving dots are then presented and the subjects respond. At the end of dots motion, the feedback is presented. If the response was correct, a pile of coins proportional to the payoff is shown. For incorrect responses and misses, a red-colored cross is displayed.
~Audience effect Each trial begins with the display of two eyes (public) or a padlock (private). The moving dots are shown and the participant answers. Audience condition changes the information available on accuracy when submitting comments. In the observed condition, an arrow shows the response. In the observed condition, no feedback is displayed."
15969438|NCT03116581|Other|fMRI (functional Magnetic Resonance Imagery)|"Both behavioral task (audience effect and vicarious reward) will be studied in fMRI (functional Magnetic Resonance Imagery). The same paradigms used in the behavioral experiment will be adapted for fMRI.
~Audience Effect experiment: trials will last for 10 seconds maximum. With 80 trials for each condition (public easy, public difficult, private easy and private difficult), the task will count a total of 320 trials and have a 54 minutes duration, in 3 runs of 17 minutes each.
~Vicarious Reward experiment: trials will have a 10 seconds maximum duration. Using 40 trials for each condition (other low payoff, other high payoff, self low payoff, self high payoff, control condition), the task will have a total of 200 trials and last for 54 minutes, in 6 runs of 9 minutes each."
15969439|NCT03116581|Other|MEG (MagnetoEncephaloGraphy)|"Both behavioral task (audience effect and vicarious reward) will be studied in MEG (MagnetoEncephaloGraphy). The same paradigms used in the behavioral experiment will be used in MEG.
~Audience Effect experiment: trials will last for 7 seconds maximum. With 100 trials for each condition (public easy, public difficult, private easy and private difficult), the task will count a total of 400 trials and have a 47 minutes duration. Every 100 trials (about 12 minutes of tasks), a break will be proposed to the participants.
~Vicarious Reward experiment: trials will have a 7.2 seconds maximum duration. Using 75 trials for each condition (other low payoff, other high payoff, self low payoff, self high payoff, control condition), the task will have a total of 375 trials and last for 45 minutes. Every 125 trials (every 15 minutes), a break will be proposed to the participants."
15969440|NCT03116555|Drug|Apatinib|Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2).
15969441|NCT03116555|Drug|Irinotecan|Irinotecan was used as second line treatment with AGC
15969442|NCT03116542|Device|Diagnostic (18F-FLT PET/CT)|The tracer compound [F-18] FLT will be injected into the patient's veins in a small volume of normal saline solution. The PET scan data collection is started immediately and is continued for 2 hours.
15969443|NCT03116529|Combination Product|Combination Radiation, Immunotherapy, Surgery|"Three doses of Durvalumab (1500 mg) and Tremelimumab (75 mg) given intravenously once every four weeks during radiotherapy prior to surgery.
~Radiation therapy delivered with a minimum dose of 50 Gy and 1.8-2 Gy per fraction. Bulky sarcomas, defined as >10 cms in greatest dimension, receive a single 15 Gy fraction of high-dose spatially fractionated (GRID) radiation therapy within 1-3 days prior to radiation therapy
~Surgical resection is performed at least 5-8 weeks after cessation of radiotherapy and 4 weeks after completion of neoadjuvant immunotherapy.
~Patients with no evidence of disease following surgical resection receive four additional doses and patients with evidence of disease receive nine additional doses of Durvalumab (1500 mg IV) once every four weeks unless there is clear progression of disease."
15969444|NCT03116516|Drug|Temisartan/Amlodipine+Rosuvastatin|All subjects will receive a single oral dose of temisartan/amlodipine+rosuvastatin administered in the morning.
15969445|NCT03116516|Drug|YHP1604|All subjects will receive a single oral dose of YHP1604 administered in the morning.
15969446|NCT03116503|Other|diagnosis of bipolar disorder and comorbid depression|Evaluation of the number of diagnosis of bipolar disorder and comorbid depression
15969447|NCT03116490|Procedure|Anesthesia type|RA group uses regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) ,and GA group uses general anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) .
15969448|NCT03116464|Behavioral|Telemental Health Family Intervention|"Approximately 12-16 session family intervention that will include the following specific strategies, the implementation of which will be tailored by clinicians to the specific interpersonal deficits identified in an assessment: (1) psychoeducation on dementia, (2) communication and problem solving skills, (3) safety building skills, (4) relationship satisfaction enhancement skills, (5) meaning making (i.e. collaboratively identifying the personal significance of events), (6) identification of core patterns from dyad relationship history, (7) techniques to shift emotional responses, (8) techniques to increase emotional attunement, and (9) techniques to increase attunement to care-recipient needs"
15969449|NCT03116451|Behavioral|Foot Health Promoting Program|An electronic intervention for 8 weeks consisting of foot self-care guidance targeted to nurses.
15969450|NCT03116425|Device|Individualized rTMS on VERUM 1's region or network|"To increase cortical rCBF, iTB (intermittent theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 2 sec with an inter-train interval of 8 sec.
~To decrease cortical rCBF, cTB (continuous theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 40 sec. Intensity 120% of passive threshold (or 150% of active threshold).
~Stimulation protocol will be used up to 5 times per session to allow a reasonable regional or network coverage.
~Patients will have 4 sessions per day on 5 successive days per arm."
15969451|NCT03116425|Device|Individualized rTMS on VERUM 2's region or network|"To increase cortical rCBF, iTB (intermittent theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 2 sec with an inter-train interval of 8 sec.
~To decrease cortical rCBF, cTB (continuous theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 40 sec. Intensity 120% of passive threshold (or 150% of active threshold).
~Stimulation protocol will be used up to 5 times per session to allow a reasonable regional or network coverage.
~Patients will have 4 sessions per day on 5 successive days per arm."
15969452|NCT03116425|Device|Individualized rTMS on PLACEBO region|"Region will be modulated up or down according to the stimulation protocol used in VERUM 1 and 2 conditions.
~Stimulation will be replicated up to 5 times per session. Patients will have 4 sessions per day on 5 successive days per arm."
15969453|NCT03116425|Procedure|Individualized rTMS on VERUM 1's region or network|"To increase cortical rCBF, iTB (intermittent theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 2 sec with an inter-train interval of 8 sec.
~To decrease cortical rCBF, cTB (continuous theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 40 sec. Intensity 120% of passive threshold (or 150% of active threshold).
~Stimulation protocol will be used up to 5 times per session to allow a reasonable regional or network coverage.
~Patients will have 4 sessions per day on 5 successive days per arm."
15969454|NCT03116425|Procedure|Individualized rTMS on VERUM 2's region or network|"To increase cortical rCBF, iTB (intermittent theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 2 sec with an inter-train interval of 8 sec.
~To decrease cortical rCBF, cTB (continuous theta burst) will be used: triplet at 50 Hz repeated at 5 Hz in trains of 40 sec. Intensity 120% of passive threshold (or 150% of active threshold).
~Stimulation protocol will be used up to 5 times per session to allow a reasonable regional or network coverage.
~Patients will have 4 sessions per day on 5 successive days per arm."
15969455|NCT03116425|Procedure|Individualized rTMS on PLACEBO region|"Region will be modulated up or down according to the stimulation protocol used in VERUM 1 and 2 conditions.
~Stimulation will be replicated up to 5 times per session. Patients will have 4 sessions per day on 5 successive days per arm."
15969456|NCT03116412|Procedure|CT or PET scans|Scans and blood tests are scheduled at baseline, months 6, 12, 24 and 36.
15969457|NCT03116399|Behavioral|PRISM 2.0 Condition|Access to the PRISM 2.0 program
15969458|NCT03116399|Behavioral|Tablet Condition|Access to the tablet
15969459|NCT03116386|Other|run-in period|observational time i.e. baseline situation
15969460|NCT03116386|Device|Control period|neither activation of any lighting environment when the resident gets up from his bed nor alert if the resident did not return to bed after 15 minutes Etolya-F ® devices will only permit detection and recording of the moment of the elderlly will leave his/her bed and recording of the moment the elderly will be found by caregivers
15969461|NCT03116386|Device|Etolya-F ® devices|Etolya-F ® devices will permit detection of absence in the bed, activation of a lighting environment when the resident gets up from his bed, transmission of alert to caregivers through the centralized system of sick call if the resident do not return to bed after 15 minutes and recording the time when caregivers will find the resident out of bed, distinguishing between a fall and a night wandering in the room or corridors without a fall
15969462|NCT03116373|Other|mandible fixation|Intubation device will be fixed on mandible
15969463|NCT03116373|Other|Maxilla fixation|Intubation device will be fixed on maxilla
15969464|NCT03116360|Diagnostic Test|Diagnostic Ultrasound|The physician performing the ultrasound will be blinded to the results of the x-ray and MRI. The physician performing the ultrasound will be informed of the bone in question (ex. Tibia) and will be able to perform a focused history and exam. The bone in which acute stress fracture is suspected will then be scanned throughout its length in two orthogonal views. The criteria for diagnosing acute stress fracture on ultrasound include displaying 2 out of 3 of the following: hypoechoic periosteal elevation of cortical bone, visible cortical disruption, hyperemia surrounding the periosteal lesion on power Doppler. The ultrasound physician will then be asked to make a determination whether the ultrasound study is positive for acute stress fracture or negative/indeterminate.
15969465|NCT03116347|Biological|HYQVIA|Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase (IGI, 10% with rHuPH20)
15969466|NCT03116347|Biological|KIOVIG|100 mg/ml solution for infusion
15969467|NCT03116347|Biological|Cuvitru|200 mg/ml solution for subcutaneous injection
15969468|NCT03116321|Drug|Eslicarbazepine acetate (ESL)|Oral Tablet of 800 mg and 200 mg of ESL
15969469|NCT03116308|Drug|Opicapone (OPC)|50 mg OPC capsules; oral route
15969470|NCT03116295|Drug|Opicapone (OPC)|Test treatment: 25 mg or 50 mg of OPC hard capsule (new API source NF) Reference treatment: Ongentys® 25 mg or 50 mg of OPC hard capsule (current API source - AF).
15969471|NCT03116282|Behavioral|E-alcohol therapy|Conversational therapy sessions provided via video conference by a professional alcohol therapist.
15969472|NCT03116269|Drug|Cilostazol 100mg|
15969473|NCT03116269|Drug|Aspirin|
15969474|NCT03116256|Dietary Supplement|Very low calorie diet (VLCD)|All participants (including exercise group) will be using full daily meal replacement during the 6-week interventional period. The total meal supplement is 600 kcal/day.
15969475|NCT03116256|Other|High intensity interval training (HIIT)|Participants in this group will be having HIIT session three times per week under close medical supervision. This involves 60 sec high intensity cycling at 95-125% Watt Max, with 90s recovery, repeated 5 times, with 2 minutes warm up and cool down.
15969558|NCT03115580|Device|Cutting Balloon Angioplasty|Cutting balloon is a special balloon catheter with three or four microsurgical blades attached longitudinally to its surface, suitable for creating discrete longitudinal incisions in the atherosclerotic target coronary segment during balloon inflation. Lesion preparation will be performed using Cutting Balloon or conventional balloon
15969476|NCT03116256|Other|Resistance exercise training (RET)|The exercise format will be 2 sets of 12 repetitions at 70% 1-RM for each resistance regime, with 1-2 minutes rest between sets after a prescribed warm-up 3 sessions/week. The resistance regimes are: (3 upper body)chest press, latissimus pull down, seated lever row; (3 lower body) leg extension, leg curl, leg press. Participants will be alternating between upper and lower body exercise during each training session.
15969477|NCT03116230|Device|Cutaneous Stimulation|A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject.
15969478|NCT03116230|Device|Knee Sleeve|Commercially-available knee sleeve.
15969479|NCT03116204|Other|Assessment of score SAS|Assessment of a score assessing physical and cognitive activities of patients in follow-up care and rehabilitation departments
15969480|NCT03116191|Drug|SK-1404|4 weeks of repeated administration of SK-1404 to the patients of nocturia
15969481|NCT03116191|Drug|Placebo|4 weeks of repeated administration of Placebo to the patients of nocturia
15969482|NCT03116178|Other|Group G -PVI( Masimo co oximeter) guided fluid therapy|"goal directed fluid therapy maintaining pvi 4-11. when pvi<4 fluid rate is 50-60ml/hr and pvi>11 200ml colloid bolus transfusion till pvi value achieves normal range.
~In the control group crystalloid was administered @ 6-8 ml/kg and blood loss was replaced by colloids. Hourly urine output was measured and if less than 0.5ml/hr bolus crystalloid 100-200ml was administered"
15969483|NCT03116178|Other|Group B- Body weight guided intravenous fluid @6-8ml/kg|Intravenous fluid @6-8ml.kg and blood loss replacement with colloids maintaining urine output of 0.5ml/kg
15969484|NCT03116165|Behavioral|Modified prolonged exposure therapy|Participants will receive three sessions of modified prolonged exposure therapy.
15969485|NCT03116165|Behavioral|Attention control|Participants will receive three sessions of supportive counselling and psychoeducation
15969486|NCT03116152|Biological|IBI308|IBI308 200mg Intravenous drip every three weeks；
15969487|NCT03116152|Drug|paclitaxel/ irinotecan|paclitaxel 175mg/㎡ Intravenous drip every three weeks or irinotecan 180mg/㎡ Intravenous drip every two weeks
15969488|NCT03116139|Diagnostic Test|V/Q imaging|Standard of care
15969489|NCT03116139|Diagnostic Test|Computed tomography scan|Standard of care
15969490|NCT03116126|Drug|Guanfacine|2mg oral daily tablet
15969491|NCT03116126|Drug|Placebo|inactive oral daily tablet
15969492|NCT03116113|Biological|BIIB112|Administered as specified in the treatment arm
15969493|NCT03116087|Drug|Testosterone patch|300 mcg testosterone patches or placebo applied twice weekly
15969494|NCT03116087|Drug|Placebo|Placebo patch
15969495|NCT03116074|Behavioral|Interactive Digital Health Tools|Discharge checklist, discharge video, safety dashboard enhanced with discharge preparation indicator, secure patient-provider messaging, condition-specific educational videos
15969496|NCT03116061|Other|Questionnaire|This questionnaire was to explore potential decompensation risk factors within themes and subthemes of multimorbidity
15969497|NCT03116048|Other|Chronic pain evaluation|Chronic pain assessment with study questionnaire
15969498|NCT03116035|Other|Web-based decision aid|Patients were randomized to receive links to a commercially available decision aid.
15969499|NCT03116035|Other|Standard websites|Patients were randomized to receive links to standard, high-quality websites.
15969500|NCT03116022|Drug|Estriol|Women using drug 1 mg / 1g in the proximal third of the vagina every other night for 12 weeks
15969501|NCT03116022|Drug|Distal estriol|Women using drug 1 mg / 1g at the distal third of the vagina every other night for 12 weeks
15969502|NCT03116022|Drug|Vaginal Gel|Women using a base water gel lubricant during intercourse
15969503|NCT03116009|Drug|Screening for diabetes with 1-hour GCT and HbA1|They will receive 50gm oral glucose tolerance test before 20 weeks and if abnormal, they will do the diagnostic test with 100gm OGTT with HbA1C.
15969504|NCT03115996|Drug|REGN3918|Intravenous (IV) or Subcutaneous (SC)
15969505|NCT03115996|Drug|Placebo|Matching Placebo
15969506|NCT03115983|Device|LimiFlex|LimiFlex implantation at a single level after surgical decompression.
15969507|NCT03115983|Device|Fusion Instrumentation|Titanium alloy top-loading, polyaxial pedicle screws and cylindrical, titanium alloy rod instrumentation using autograft and/or allograft bone (i.e., cancellous and/or corticocancellous bone only), and/or a synthetic bone graft extender that is on-label for these indications (i.e., decorticated posterolateral gutter only). The TLIF requires a single PEEK or Titanium TLIF cage cleared by FDA for this indication filled with autograft and/or allograft bone (i.e., cancellous and/or corticocancellous bone only).
15969508|NCT03115983|Procedure|Decompression|Surgical decompression at one or two contiguous levels for L1 to S1.
15969509|NCT03115983|Procedure|Fusion|Transforaminal lumbar interbody fusion (TLIF) with concomitant posterolateral fusion (PLF) at a single level after surgical decompression.
15969510|NCT03115970|Procedure|capillary and venous lactate level measurement|capillary and venous lactate level measurement
15969511|NCT03115957|Other|Parenteral Nutrition|Patients who can not tolerate 30% of target energy EN will receive supplemental parenteral nutrition at day 3 or at day 8 after abdominal surgery.
15969512|NCT03115944|Device|Alma vShape Ultra|UltraSpeed ultrasound treatment, a series of four treatments
15969513|NCT03115931|Other|no intervention|no intervention
15969514|NCT03115918|Device|Pancreatic Duct Stent Placement|Patients will be randomly allocated to either treatment arm to have a PD stent placed.
15969515|NCT03115918|Other|No Pancreatic Duct Stent Placement|Patients will be randomly allocated to either treatment arm and not receive PD placement.
15969516|NCT03115892|Drug|Green Tea With Aloe Vera mouthwash|measuring Tool/device Smell identification test ( organoleptic score ) (human nose) to measure of malodor which its unit 0-5 score
15969517|NCT03115892|Drug|Chlorhexidine mouthwash|chlorohexidine mouthwash take two times per day for one week
15969518|NCT03115879|Other|Hip mobilization|High velocity low amplitude hip mobilization of the experimental group
15969519|NCT03115879|Other|Hip manipulation simulation|Hip manipulation simulation
15969559|NCT03115567|Drug|Triamcinolone|6 weeks of twice daily application of 0.1% triamcinolone cream to the face, chest, and back.
15969784|NCT03113812|Drug|ABvac40|
15969785|NCT03113812|Drug|Placebo|
15969520|NCT03115866|Behavioral|FRUVEDomics|FRUVEDomics is a behavioral nutrition intervention in young adults 'at risk for metS' and young adults 'with metS' to identify modifiable metabolomics and microbiome risk. Group nutrition education including basic nutrition for the prescribed intervention, culinary tool kit distribution, sample budget and grocery shopping tips were delivered to each participant group prior to the start of the intervention. Participants underwent individual weekly consultations with a Registered Dietitian Nutritionist using food logs, food pictures and receipt management, to assess adherence and cost of the intervention.
15969521|NCT03115853|Drug|Aliskiren 150 mg|Aliskiren 150 mg daily for 2 weeks
15969522|NCT03115853|Drug|Placebo|Placebo tablet for Aliskerin
15969523|NCT03115853|Drug|HCTZ|HCTZ 25mg every day for 18 weeks
15969524|NCT03115853|Drug|Aliskiren 300 mg|Aliskiren 300 mg for 4 weeks
15969525|NCT03115827|Drug|Droxidopa|Droxidopa will be started at 100mg twice a day and titrated up to a maximum of 600mg twice a day
15969526|NCT03115827|Drug|Carbidopa|Carbidopa 200mg twice a day
15969527|NCT03115801|Drug|Nivolumab|Nivolumab will be given to patients with renal cell carcinoma on days 1,15, 29, 43 and 57.
15969528|NCT03115801|Drug|Atezolizumab|Atezolizumab will be given to patients with urothelial carcinoma on days 1,22,43,64.
15969529|NCT03115801|Radiation|Radiation & immunotherapy|Radiation is given to one lesion, 30 Gray (Gy) in 3 fractions of 10 Gy each. over a one week interval (with a minimum of 36hrs between each fraction). On the day of radiation (Day 1) immunotherapy is administered and repeated on the scheduled days. Patients will receive radiation on Day 1 and immunotherapy will be given ± 24hr from Day 1.
15969530|NCT03115801|Drug|Pembrolizumab|Pembrolizumab will be given to patients with urothelial carcinoma on days 1,22,43,64.
15969534|NCT03115775|Dietary Supplement|Conjugated linoleic acid|Intervention will last up to 8 weeks. Subjects will receive conjugated linoleic acid (4000 mg Tonalin FFA 80) daily.
15969535|NCT03115775|Dietary Supplement|Vitamin D|Intervention will last up to 8 weeks. Subjects will receive vitamin D3 (2000 IU) daily.
15969536|NCT03115775|Dietary Supplement|Conjugated linoleic acid and Vitamin D|Intervention will last up to 8 weeks. Subjects will receive conjugated linoleic acid (4000 mg Tonalin FFA 80) and vitamin D3 (2000 IU) daily.
15969537|NCT03115775|Other|Corn oil (placebo)|Intervention will last up to 8 weeks. Subjects will receive corn oil (4000 mg) daily.
15969538|NCT03115762|Biological|bevacizumab|recombinant humanized monoclonal antibody produced by DNA technology in Chinese Hamster Ovary cells
15969539|NCT03115762|Biological|ASKB1202|
15969540|NCT03115749|Other|Intestinal biopsies during colonoscopy|Intestinal biopsies during colonoscopy
15969541|NCT03115749|Other|Biopsies taken on surgical specimen|biopsies taken on surgical specimen after intestinal resection
15969542|NCT03115736|Drug|Tenofovir Alafenamide|Patients are switched to either Genvoya (TAF/FTC/EVG/COB) or another FTC/TAF-containing ART regimen
15969543|NCT03115723|Procedure|Percutaneous coronary intervention|
15969544|NCT03115723|Procedure|Coronary angiography|
15969545|NCT03115710|Diagnostic Test|Rotating Scheimpflug camera (Pentacam HR)|One visit to Ophthalmology Department is required from participant. Parents or legal guardians must attend with their child. The interview and test during visit take approximately 15 minutes. Interview includes filling out a questionnaire about risk factors of the disease and double check on understanding the consent form. The child will sit in front of the instrument (Pentacam HR Scheimpflug imaging system). The rotational measuring procedure generates Scheimpflug images in three dimensions. The images taken during the examination are digitalized, and all image data are transferred to the computer. It calculates a 3D virtual model of the anterior eye segment, from which all additional information is derived.
15969546|NCT03115697|Drug|Lactulose|Lactulose 20 mL
15969547|NCT03115697|Drug|Rifaximin|Rifaximin 550 BD
15969548|NCT03115697|Biological|Plasmapheresis|Plasmapheresis 8 hrly duration
15969549|NCT03115671|Dietary Supplement|Vayarin|Vayarin capsule
15969550|NCT03115658|Behavioral|Physical Activity|12 week print based intervention
15969551|NCT03115645|Other|Dynamic Work|The intervention consists of the introduction of sit-stand workstations and desk bikes in the participants work environment in a ratio of 1:2 with traditional desks and chairs. Employees will receive a half hour intervention session at the start of the intervention from an occupational physiotherapist, who will provide further intervention support in the ensuing 12 weeks. Intervention participants will also receive an activity tracker which provides feedback on sitting time and physical activity levels.
15969552|NCT03115619|Drug|Pirfenidone|Participants will receive pirfenidone therapy as per clinical practice or summary of product characteristics (SmPC).
15969553|NCT03115606|Device|C-Mac D Blade|Videolaryngoscope
15969554|NCT03115606|Device|Fastrach LMA|Laryngeal mask airway
15969555|NCT03115593|Procedure|Blind biopsy with a pipette|Patients willing to participate to the study will benefit from a double biopsy. The first biopsy will be a blind biopsy performed by aspiration with a Cornier pipette.
15969556|NCT03115593|Procedure|Targeted biopsy using hysteroscopy|During the same consultation, patients will benefit from a diagnostic hysteroscopy with vaginoscopy and saline (allowing a wash of the debris caused by the pipette biopsy), using a rigid hysteroscope of 4.3 mm equipped with an operator channel allowing the passage of a biopsy tong.
15969557|NCT03115580|Device|Rotational atherectomy|"Rotational atherectomy for the treatment of bifurcation lesions to remove plaque with minimal injury to adjacent normal arterial segments and potentially reduce plaque shifting, the snow plow effect."
15969617|NCT03115112|Drug|Placebo for sitagliptin|inactive tablets to match the appearance of sitagliptin tablets
15969560|NCT03115554|Procedure|PVI Plus Catheter Ablation|Patients with sustained AF following PVI will receive additional linear or focal intracardiac catheter ablation for AF.
15969561|NCT03115554|Procedure|PVI Alone|Patients with sustained AF following PVI will not receive additional linear or focal intracardiac catheter ablation for AF.
15969562|NCT03115528|Behavioral|Estimation of Prognosis Questionnaire|Survey will examine two aspects of prognosis estimation: 1.) physician factors, 2.) prognosis estimation and contributing factors to patient prognosis. Survey will take approximately 5 minutes to complete.
15969563|NCT03115515|Drug|levothyroxine|To compare two different methods of adjusting thyroid hormone replacement during pregnancy to maintain TSH within the normal reference range for pregnancy.
15969564|NCT03115489|Drug|Traditional Treatment (Group T)|Patients will receive traditional drug infusions
15969565|NCT03115489|Drug|Ketamine Infusion (Group K)|Patients will receive loading dose of 2.5 mg/kg of ketamine followed by a continuous infusion with a starting dose of 3mg/kg/hr with titration in 1mg/kg/hr increments until burst suppression is achieved or a maximum dose of 10mg/kg/hr is reached
15969566|NCT03115476|Drug|ingenol disoxate gel 0.018%|Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.
15969567|NCT03115476|Drug|ingenol disoxate gel 0.037%|Ingenol disoxate gel is a novel ingenol derivative being developed for field treatment of AKs on treatment areas of up to 250 cm2 (40 in2) on the face, chest and scalp.
15969568|NCT03115476|Other|Vehicle gel|Vehicle to ingenol disoxate gel with no active ingredient
15969569|NCT03115463|Other|Titration of oxygen during neonatal resuscitation|Resuscitation will be initiated at 30% O2 and target goal saturations will be the 10th to 25th percentile saturations in OX25 and 75th percentile in OX75 group. The control group will be resuscitated with the OX50 strategy in which resuscitation will be initiated with 30% O2 and target goal saturations will be the approximated median SpO2 observed in healthy term newborns as per current NRP guidelines. For the first 6 minutes after birth, target ranges of of all 3 arms are different. After 6 min, the target ranges are are identical.
15969572|NCT03115437|Other|Hard cushioned running shoes|The participants allocated to this experimental group will have to perform all their running sessions with the study shoes they received the day of their inclusion to the study and characterized by hard cushioning.
15969573|NCT03115437|Other|Soft cushioned running shoes|The participants allocated to this experimental group will have to perform all their running sessions with the study shoes they received the day of their inclusion to the study and characterized by soft cushioning.
15969574|NCT03115424|Drug|Saxenda|Saxenda is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to a reduced calorie diet and increased physical activity for chronic weight management in adult patients. Subjects will be recruited and screened prior to undergoing bariatric surgery. Subjects undergoing SG will be randomized 1:1 at month 3 post surgery to Saxenda, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects will remain on study drug for duration of study (33 months). After undergoing surgery, study visits will be timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.
15969575|NCT03115424|Drug|Placebos|Subjects will be recruited and screened prior to undergoing bariatric surgery.Subjects undergoing SG will be randomized 1:1 at months 3 post surgery to Placebo, 0.6mg SQ daily, with weekly titration of 0.6mg until maintenance dose of 3mg/daily reached. Subjects will remain on study drug for duration of study (33 months). After undergoing surgery, study visits will be timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.
15969576|NCT03115424|Procedure|RYGB|Subjects will be recruited and screened prior to undergoing bariatric surgery. After undergoing surgery, study visits will be timed to coincide with the standard clinical follow-up visits at months 3, 6, 9, 12, 18, 24, 30 and 36.
15969577|NCT03115411|Device|Winged biliary stent (ViaDuct™)|Placement of winged biliary stent at ERCP for management of benign biliary stricture.
15969578|NCT03115398|Behavioral|Pedometer-based Walking Program|Patients will be instructed to meet the daily step count goal displayed on their fitness tracker. If goal is not being met, study team will intervene and reinforce the importance of meeting this goal. Intervention will include a conversation with the patient, led by a study coordinator, to identify any challenges present in meeting the prescribed goal. Solutions to such challenges may be offered by the coordinator or necessary provider, such as a dietitian, when applicable.
15969579|NCT03115385|Dietary Supplement|VSL#3|VSL#3 will provide active packets. Subjects will take 2 to 3 packets per day with for 16 weeks. The study team will supply each participant with all necessary packets on a weekly or bi-weekly basis within 1-2 weeks after their first visit. VSL#3 probiotic is provided in powder form and needs to be mixed with cold, non-fizzy liquid for consumption. For this reason, the study team will also provide participants with zero calorie sugar fee beverages to mix their packet with (e.g., vitamin water zero with stevia).
15969580|NCT03115385|Dietary Supplement|Placebo|A matched placebo to VSL#3 will be provided. The placebo will be identical to the active VSL#3 probiotic in aspects such as packaging, color, taste, texture, shape, and odor. The placebo will not contain active ingredients. The study team will supply each participant with all necessary packets on a weekly or bi-weekly basis within 1-2 weeks after their first visit. The placebo is provided in powder form and needs to be mixed with liquid for consumption. For this reason, the study team will also provide participants with zero calorie sugar fee beverages to mix their packet with (e.g., vitamin water zero).
15969581|NCT03115372|Other|Educational Intervention|Attend CRC education session
15969582|NCT03115372|Other|Educational Intervention|Attend healthy nutrition session
15969583|NCT03115372|Other|Informational Intervention|Receive CRC screening brochure
15969584|NCT03115372|Other|Survey Administration|Ancillary studies
15969585|NCT03115372|Behavioral|Telephone-Based Intervention|Receive telephone reminder about CRC screening
15969586|NCT03115372|Behavioral|Telephone-Based Intervention|Receive telephone reminder about healthy nutrition
15969618|NCT03115112|Drug|Placebo for bexagliflozin|inactive tablets to match the appearance of bexagliflozin tablets
15969619|NCT03115099|Drug|LY3325656|Administered orally
15969620|NCT03115099|Drug|Placebo|Administered orally
15969587|NCT03115359|Behavioral|Mindfulness Meditation|"The Mindfulness Meditation intervention will teach participants the mindfulness meditation-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study.
~In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations."
15969588|NCT03115359|Behavioral|Cognitive Behavioral Therapy|"The Cognitive Behavioral Therapy (CBT) intervention will teach participants the CBT-based strategies, tailored to the needs of those with opioid-treated chronic lower back pain. It consists of eight weekly 2-hour group sessions guided by trained therapists. In addition to session attendance, participants are asked to practice at home at least 6 days/week, 30 minutes/day during the study.
~In addition to the intervention, the participants will receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations."
15969589|NCT03115346|Other|Decision aid|Decision aid for repair type for aortic abdominal aneurysms
15969591|NCT03115320|Drug|Human chorionic gonadotropin|Human chorionic gonadotropin (Pregnyl, 5000IU) is used in the medication group to confirme the ovulation.
15969592|NCT03115320|Other|Home ovulation test|The ovulation in the natural menstrual cycle is confirmed by the home ovulation tests from the urine.
15969593|NCT03115307|Drug|Triptorelin|Triptorelin 0,1mg/ml subcutaneously once in a luteal phase in insemination cycles.
15969594|NCT03115294|Drug|Theophylline|iv injection
15969595|NCT03115294|Procedure|Ventilator positive end expiratory pressure adjustment|Positive end-expiratory pressure variation
15969596|NCT03115294|Device|Videorecording|Myocardial movement videorecording
15969597|NCT03115281|Device|PCI|PCI
15969598|NCT03115268|Behavioral|Social support groups delivered in EVA Park|Intervention will comprise support group meetings delivered in EVA Park, a virtual island created for people with aphasia. Scheduled meetings will be held every two weeks, led by the group co-ordinator and volunteers. Participants will have unlimited access to EVA Park, so will be able to meet up with other group members between meetings.
15969599|NCT03115255|Drug|intravitreal ranibizumab|0.25 mg intravitreal ranibizumab to either 1 eye (unilateral cases) or both eyes (bilateral cases)
15969600|NCT03115242|Other|Contrast injection Sonovue®|In addition to standardized assessment routine care, a contrast injection will be performed during the neck vessels doppler ultrasound.
15969601|NCT03115229|Behavioral|Protective Nursing Interventions for Reduction Obesity Risk|"Applications for the experimental group for 11 weeks are grouped under three headings.
~These; Nutritional habits, practices for physical activity, and motivational messages sent via social media.
~Nutritional practices: Nutritional practices consist of group trainings, individual practices and collective events.
~Practices for physical activity: Group trainings, group exercises, individual exercises and collective activities. Physical activity was done for 3 days per week and 45-60 minutes every seans for 8 weeks. In addition, activities such as collective nature walks and cycling have been carried out Practices through social media: For physical activity and healthy eating; Motivational messages were sent twice a week for 11 weeks."
15969602|NCT03115216|Procedure|FLA-CEIOL|Femtosecond laser-assisted cataract extraction and intraocular lens placement
15969603|NCT03115216|Procedure|CEIOL|Manual cataract extraction and intraocular lens placement
15969604|NCT03115203|Other|Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in patients with sequelae of facial paralysis|Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in patients with sequelae of facial paralysis
15969605|NCT03115203|Other|Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in healthy subjects|Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle in healthy subjects (data obtained from the SIMOVI project being published).
15969606|NCT03115190|Diagnostic Test|General Practitioner diagnosis with Heart score|All patients seen by the general practitioner (GP) at the GP cooperation and agreeing to participation will be evaluated with the Heart score. This is a score including history, electrocardiogram, age, risk factors and troponin to assess whether a patient is at high risk for acute coronary syndrome. The troponins asked for in the Heart score are at arrival of the patient, not regarding the time of onset of chest pain. We shall use point of care (POC) troponin, thereby modifying the Heart score. The GP must realize that the POC troponin is not reliable on its own with one test. If the Heart score is low, it is acceptable and safe to not refer the patient, it is however not safe to refer the patient solely on negative troponin result.
15969607|NCT03115177|Drug|Doxycycline|The treatment group will receive 100mg of doxycycline IV in addition to cefazolin within 1 hour of incision for total shoulder arthroplasty.
15969608|NCT03115177|Drug|Cefazolin|
15969609|NCT03115164|Other|To study the characteristics of patients with DIA / DIG|Describe the characteristics of patients with DIA / DIG treated in French SFCE pediatric oncology centers according to whether these tumors behave in a benign or malignant manner.
15969610|NCT03115151|Drug|Bupivacaine|Bupivacaine (0.0625%) will be combined with fentanyl for postoperative epidural analgesia via a lumbar epidural catheter
15969611|NCT03115151|Drug|Hydromorphone|Hydromorphone will be given continuous infusion for intravenous patient controlled analgesia (syringe 25 mg/50 mL).
15969612|NCT03115151|Drug|Fentanyl|Fentanyl (2 mcg/ml) will be given via epidural route together with bupivacaine.
15969613|NCT03115138|Other|Correlation between molecular anomalies of the primary tumor and circulating tumor DNA|The presence of a specific abnormality initially identified on the primary tumor and which can be quantified in the cDNA during the management will allow a better follow-up of the patient.
15969614|NCT03115125|Other|Describe for the first time the kinetics of evolution in proportion of the circulating Brég in patients with severe septic state, at times D0, D2, D7 and D14 of hospitalization in medical reanimation.|Describe for the first time the kinetics of evolution in proportion of the circulating Brég in patients with severe septic state, at times D0, D2, D7 and D14 (or on leaving the service if before D14) of hospitalization in medical reanimation.
15969615|NCT03115112|Drug|Bexagliflozin|tablets containing 20 mg bexagliflozin
15969616|NCT03115112|Drug|Sitagliptin|tablets containing 100 mg sitagliptin
15969626|NCT03115060|Drug|intravenous fluid administration WITH NORMAL SALINE, PLASMALYTE A, OR RINGER LACTATE|intravenous fluid to be used for maintainance and replacement during renal transplant surgery will be normal saline, ringer lactate or plasmalyte A depending on the arm of intervention
15969627|NCT03115047|Drug|Dexmedetomidine Injection|0.35 mcg/kg intravenous in 2 minutes if shivering 5 minutes after delivery
15969628|NCT03115047|Drug|Meperidine Injection|0.35 mg/kg intravenous in 2 minutes if shivering 5 minutes after delivery
15969629|NCT03115034|Drug|Melatonin|Patients under CEA taking 6mg/day melatonin orally from 3 days before operation to 3 days after operation.
15969630|NCT03115034|Drug|placebo|Patients under CEA taking placebo orally from 3 days before operation to 3 days after operation.
15969631|NCT03115034|Other|blank|Patients under CEA without taking melatonin or placebo
15969636|NCT03115008|Behavioral|Video-based terminal feedback|Terminal feedback is given after skill performance using video-based coaching coupled with a validated polypectomy assessment tool
15969637|NCT03114995|Drug|Tirofiban|
15969638|NCT03114982|Biological|NBP608|Preparation of the Oka/SK strain of live, attenuated varicella virus
15969639|NCT03114982|Biological|Varivax|Preparation of the Oka/Merck strain of live, attenuated varicella virus
15969640|NCT03114969|Device|Relvar ELLIPTA|ELLIPTA inhaler containing Relvar will be used by subjects as their maintenance treatment to control COPD.
15969641|NCT03114969|Device|Symbicort TURBUHALER|TURBUHALER inhaler containing Symbicort will be used by subjects as their maintenance treatment to control COPD.
15969642|NCT03114969|Device|Seretide DISKUS|DISKUS inhaler containing Seretide will be used by subjects as their maintenance treatment to control COPD.
15969643|NCT03114969|Device|Spiriva HANDIHALER|HANDIHALER inhaler containing Spiriva will be used by subjects as their maintenance treatment to control COPD.
15969644|NCT03114969|Device|BREEZHALER|BREEZHALER inhaler containing either Seebri or Ultibro will be used by subjects as their maintenance treatment to control COPD.
15969645|NCT03114969|Device|Incruse ELLIPTA|ELLIPTA inhaler containing Incruse will be used by subjects as their maintenance treatment to control COPD.
15969646|NCT03114969|Device|Anoro ELLIPTA|ELLIPTA inhaler containing Anoro will be used by subjects as their maintenance treatment to control COPD.
15969647|NCT03114956|Procedure|Gauze|Implant surface will be wiped with sterile gauze soaked alternatively in sterile saline and CHX (5 times)
15969648|NCT03114956|Procedure|Titanium brush|Titanium brush: Titanium brush (TiBrush, Straumann, Switzerland) mounted on an oscillating hand piece will be used for 1 minute.
15969649|NCT03114956|Procedure|Air powder abrasion|Air powder abrasion: One minute of air powder abrasion using Glycine prophy powder (Prophy Jet, Dentsply, USA) with overlapping passes form apical to coronal direction for 1 minute.
15969650|NCT03114956|Procedure|Comprehensive|A comprehensive treatment including the use of titanium brush and air powder abrasion (as described above) and 30 seconds etching with 9.6% HF acid gel (Premier, USA) applied with a micro-applicator tip (Unipack Medical, USA), followed by copious irrigation with sterile saline.
15969651|NCT03114943|Biological|NBP608|Preparation of the Oka/SK strain of live, attenuated varicella virus
15969652|NCT03114943|Biological|Varivax|Preparation of the Oka/Merck strain of live, attenuated varicella virus
15969653|NCT03114930|Other|"To study the absence of increased complications and events occurring in the mother-newborn"|"To study the absence of increased complications and events occurring in the mother-newborn couple who made a standard exit compared to the mother-newborn couples who had benefited from an extra day of  Hospitalization in maternity."
15969654|NCT03114917|Other|Cognitive AppRoaches to coMbatting Suicidality (CARMS)|The investigators' psychological therapy is a recovery-focused, structured, time-limited, socio-cognitive intervention. It is based upon the investigators' recently developed treatment manual (Tarrier et al., 2013) and pilot RCTs in the community (Tarrier et al., 2014) and in prison (Tarrier et al., accepted). The intervention modifies negative appraisals of emotional regulation, social support, and interpersonal problem-solving. As a consequence, perceptions of defeat, entrapment, and hopelessness will be improved indirectly. In addition, perceptions of defeat, entrapment, and hopelessness will be worked on directly during the therapy.
15969655|NCT03114904|Other|Variation of Jasinski score between H0 (stop of sedatives) and H6|To compare the effectiveness of a withdrawal management protocol with the usual management in cerebral patients (Subarachnoid haemorrhage (HSA), stroke and head trauma (CT))
15969656|NCT03114891|Procedure|Theta-burst stimulation|A normal, FDA-approved clinical application of TMS involves long trains of repetitive TMS applied for approximately 40 minutes, 5 days/week, over 2-6 weeks, for a total of 10-30 TMS visits. The present study utilizes the same FDA-approved devices (Magventure Cool-Coil B65, MagVenture X100 Stimulator) to administer treatment. We will be modifying the FDA-approved protocol to stimulate in a well-replicated protocol, theta-burst stimulation (Huang et al., 2005), which will result in a greatly reduced number of total pulses delivered to the subject in any given TMS session.
15969691|NCT03114579|Device|Intraoperative heart rate measurement (reference method)|Measurement of cardiac output by both monitors: NEXFIN HD and oesophageal doppler, blood pressure measurement by the catheter and NEXFIN HD monitor, and cardiac output and blood pressure measurements after treatment administration (vasoconstrictor or filling)
15969692|NCT03114579|Device|NEXFIN HD|
15969657|NCT03114878|Other|TRT / EMDR|"Tinnitus Retraining Therapy:
~TRT is a therapy developed by Prof. Pawel Jastrebroff and Dr. Jonathan Hazell. During the counseling, the patient is educated about the work mechanism of tinnitus and how to deal with the emotional and physical responses. The main goal is to habituate to the sound of the ringing in the ears.
~Eye Movement Desensitization and Reprocessing:
~This is a scientifically, psychotherapeutic approach, developed in 1987 by Francine Shapiro. EMDR represents a specific method within a wider theoretical model called 'Adaptive Information Processing (AIP)'. Within the treatment bilateral stimulation is used i.e. visual, auditory and tactile stimuli can be used to stimulate both the left - and the right hemisphere."
15969658|NCT03114878|Behavioral|TRT / CBT|"Tinnitus Retraining Therapy:
~TRT is a therapy developed by Prof. Pawel Jastrebroff and Dr. Jonathan Hazell. During the counseling, the patient is educated about the work mechanism of tinnitus and how to deal with the emotional and physical responses. The main goal is to habituate to the sound of the ringing in the ears.
~Cognitive Behavioral Therapy:
~CBT is the combination of behavioral therapy with interventions that have been developed from cognitive psychology. The founders of CBT are Aaron Beck and Albert Ellis. The core idea is the assumption that so-called negative cognitions are responsible for dysfunctional behavior. The techniques used in the cognitive behavioral therapy focus on changing the content of these irrational cognitions."
15969659|NCT03114865|Drug|Blinatumomab|Cycle 1 - Days 1-7: 9 ug/day IV daily
15969660|NCT03114865|Drug|Blinatumomab|Cycle 1 - Days 8-28: 28 ug/day IV daily
15969661|NCT03114865|Drug|Blinatumomab|Cycle 2 - Days 1-28: 28 ug/day IV daily
15969662|NCT03114865|Drug|Dexamethasone|Day 1 of Cycle 1 and 2, prior to a step dose (such as cycle 1 day 8), or when restarting an infusion after an interruption of 4 hours or more: 20 mg IV
15969663|NCT03114852|Diagnostic Test|blood collection|They will have blood tested to renal genetic diseases
15969664|NCT03114839|Dietary Supplement|Lactobacillus casei strain Shirota (LcS)|A fermented milk containing LcS, 65 ml for oral administration, 1 bottle per day for 7 days. One bottle of the drink contains: 42.9 kcal/182 kJ; less than 0.1 g of fat; 9.6 g of carbohydrate; 0.01 g of sodium; 0.9 g of protein; and at least 6.5 x 10^9 colony-forming units of LcS.
15969665|NCT03114826|Genetic|To study the polymorphism of the gene encoding VEGF (rs699947) as a predictive marker|Study the polymorphism of the gene encoding VEGF (rs699947) as a predictive marker of the occurrence of renal cell carcinoma in renal transplant patients.
15969666|NCT03114813|Drug|Carvedilol|Non-selective beta-blocker as per routine clinical care
15969667|NCT03114813|Other|MRI scan|One hour non-invasive MRI scan
15969668|NCT03114813|Procedure|Hepatic Venous Pressure Gradient (HVPG)|Second HVPG to evaluate treatment response
15969669|NCT03114800|Device|E-Scale|The E-Scale is comprised of a series of weight monitoring 'pods' and a set of software modules that facilitate data transfer and analysis.
15969670|NCT03114787|Other|Study on patients with respiratory resuscitation|Patient intubated with mechanical ventilation in VS-AI mode, whose weaning is difficult
15969671|NCT03114774|Device|The bispectral index (BIS) monitoring|
15969672|NCT03114774|Behavioral|Ramsay Sedation Scale (RSS) Score monitoring|
15969673|NCT03114761|Radiation|CT angiography|Patients are subjected to a standard abdominal CT scan and (additional in this study) to abdominal CT angiography (CTA)
15969674|NCT03114748|Other|EEG|
15969675|NCT03114748|Other|DBS switched OFF and ON|
15969676|NCT03114722|Drug|Citrate 4%|In patients randomised to the citrate arm, the PICC line will be locked with a total of 1.6ml of citrate 4% (0.8ml per lumen in a double-lumen PICC), between each use. Lines will also be flushed with 20ml of normal saline and locked with the locking agent twice a week, if the time elapsed between each use is more than one week. This is part of the standard local protocol. Patients will be followed for up to 6 months or until the catheter is removed, or until the study ends
15969677|NCT03114722|Drug|Heparinised saline (10U/ml)|In patients randomised to the heparinised saline arm, the PICC line will be locked with 10U/ml heparinised saline between each use. Lines will also be flushed with 20ml of normal saline and locked with the locking agent twice a week, if the time elapsed between each use is more than one week. This is part of the standard local protocol. Patients will be followed for up to 6 months or until the catheter is removed, or until the study ends
15969678|NCT03114709|Other|Mindful Movement|The program focuses on enhancing individuals' mindfulness capabilities and skills, specifically attention regulation, body awareness, emotional regulation, and shifts in self-perception, by providing opportunities for education, practice, and social support in mindfulness practices and physical activity.
15969679|NCT03114709|Other|10 Keys to Health & Wellbeing|This community-based educational program provides participants useful content focused on general health related topics including common chronic conditions, social support, social participation, cancer screening, immunization and keeping active.
15969680|NCT03114696|Dietary Supplement|IQP-AO-101|1 dose (sachet) to be consumed 30 - 60 mins before bedtime
15969681|NCT03114696|Dietary Supplement|Placebo|1 dose to be consumed 30 - 60 mins before bedtime. (Identical to investigational product)
15969682|NCT03114683|Drug|PD1|IBI308 200mg/3 weeks
15969683|NCT03114670|Biological|CD123CAR-41BB-CD3zeta-EGFRt-expressing T cells|a single dose of CD123CAR-41BB-CD3zeta-EGFRt-expressing T cells will be infusion after preconditioning.
15969684|NCT03114657|Drug|Crenezumab|Crenezumab was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.
15969685|NCT03114657|Drug|Placebo|Placebo was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.
15969686|NCT03114644|Other|Physiologically evaluate the impact of reading history on the mother-baby synchronies in a context of premature birth requiring hospitalization in neonatal medicine.|Physiologically evaluate the impact of reading history on the mother-baby synchronies in a context of premature birth requiring hospitalization in neonatal medicine.
15969687|NCT03114631|Biological|Dendritic cells pulsed with tumor lysate|
15969688|NCT03114631|Biological|Dendritic cells pulsed with MUC-1/WT-1 peptides|
15969689|NCT03114605|Behavioral|Mindfulness-based Intervention|
15969690|NCT03114592|Other|mHealth tool|"The curriculum in the mHealth tool was derived in consultation with patient safety, informatics and adult educational curricula experts, and is comprised of clinical vignettes describing the post-hospital discharge stories of two hypothetical AKI survivors. opics of emphasis included NSAID risk awareness and avoidance of volume depletion when ill (Sick Day Protocol)."
15969693|NCT03114566|Other|Leukapheresis|Blood is removed together with an anticoagulant from a vein and separated into white cell rich and red cell rich fractions by centrifugation. The white cells are then saved to generate immune cells and the red cells are reinfused back through the donor's vein.
15969694|NCT03114553|Genetic|MeTree|Software program collecting family health history and generating clinical decision support for risk-based preventive care
15969695|NCT03114540|Drug|GBT440|Oral
15969696|NCT03114527|Drug|Ribociclib|Orally bioavailable, highly selective small molecule inhibitor of CDK4/6
15969697|NCT03114527|Drug|Everolimus|mTOR inhibitor
15969698|NCT03114514|Biological|PRP|PRP will be injected subcutaneously around the eyes at three different time points with one-month interval
15969699|NCT03114501|Behavioral|Yoga|Participants receive yoga sessions up to 5 days per week, based on the patient's schedule, over the course of patients' Radiation Therapy (up to 15 sessions, 45-60 min. each). Yoga sessions audio and video recorded.
15969700|NCT03114501|Behavioral|Yoga Questionnaire|Questionnaire completed during each week of radiation therapy about participant's feelings about the yoga sessions.
15969701|NCT03114501|Behavioral|Symptom Questionnaires|Symptom questionnaires completed before first radiation treatment, during week 3 of radiation therapy, and again after completion of treatment schedule (usually 6 weeks later).
15969702|NCT03114488|Device|tDCS|Transcranial electrical stimulator
15969703|NCT03114475|Radiation|CO2 laser irradiation|CO2 laser irradiation will be applied onto the enamel surrounding the orthodontic bracket
15969704|NCT03114475|Other|Placebo|No irradiation is going to be applied in the intervention. Just a red light will be used as placebo.
15969705|NCT03114462|Radiation|Stereotactic Hypofractionated Radioablation|Starting dose is 8.0 Gy per fraction for 5 fractions (total dose = 40.0 Gy). Subsequent cohorts of participants receive an additional 0.5 Gy per fraction.
15969706|NCT03114462|Behavioral|Questionnaires|Quality of life and symptom questionnaires completed at: Baseline, on days receiving HYDRA, 6 weeks after last dose of HYDRA, 3 months after last dose of HYDRA, and 6 months after last dose of HYDRA. Also after the 6 month follow-up visit, every 3 months for the first 2 years, and then every 6 months after that for up to 5 years.
15969707|NCT03114449|Device|Auricular acupuncture|Auricular acupuncture with indwelling fixed needles at specific AA points
15969708|NCT03114449|Device|Sham auricular acupuncture|Sham auricular acupuncture (AA) with indwelling fixed needles applied at non-AA points
15969709|NCT03114436|Other|Observational Data Collection|All aspects of deceased donor care in the ICU.
15969710|NCT03114423|Other|EMDR-Therapy|The EMDR-protocol from Hase (2008) was used
15969711|NCT03114423|Other|Sham Intervention|For the training the COGPACK-program from Marker (2008) was used
15969712|NCT03114410|Behavioral|Re:MIX, a multi-layer comprehensive teen pregnancy prevention intervention aimed at reducing pregnancy and STIs among youth ages 13-17|Re:MIX is a comprehensive in-school health curriculum and teen pregnancy prevention program for adolescents covering a broad range of topics related to sexual health and youth development, including healthy relationships, communication, gender, consent, reproductive anatomy, contraception, sexual decision making, clinics, parenthood, and life planning. Re:MIX also aims to connect students and young parent educators with community resources and service linkages. The Re:MIX curriculum teaches mixed-gender groups of students in grades 8 to 10 to delay sex and use protection if they have sex. A co-facilitation team of young parent educators delivered the information with professional health educators using non-traditional approaches, such as game-based tools, technology, and storytelling. Youth received roughly nine hours and 10 minutes of group sessions during the school day over one semester (55 minutes per week for 10 weeks).
15969713|NCT03114397|Device|transcranial direct current stimulation - active|transcranial direct current stimulation will be applied over the left dorsolateral at 2 mA for 20minutes.
15969714|NCT03114397|Device|transcranial direct current stimulation - sham|transcranial direct current stimulation will be applied over the left dorsolateral at 2 mA for 20minutes. The sham intervention consists of 30 seconds of stimulation at the beginning and the end of the 20minutes of intervention.
15969715|NCT03114384|Other|Creation and detection of patient-respirator asynchronies|The provocation of leaks on the Ventilation circuit and expiratory trigger modulation will generate a number of asynchronies between the subject and the respirator
15969716|NCT03114371|Drug|Oxytocin|The study drug is oxytocin in intra-nasal administration, Syntocinon®, reconditioned as a placebo-like spray. The dosage administered will be 8 International Unit, ie 1 spray (4 International Unit per spray) in each nostril per day for the first 12 weeks, in 3 and 6 years old patients. The dosage administered will be 16 International Unit or 2 sprays in each nostril per day for the first 12 weeks, in 3 to 6 years old patients.
15969717|NCT03114371|Drug|Placebo|Placebo should be used as a spray, similar to that of the oxytocin. The dosage administered will be 1 spray in each nostril per day for the first 12 weeks in 3 to 6 years old patients. The dosage administered will be 2 sprays in each nostril per day for the first 12 weeks, in 7 to 12 years old patients.
15969718|NCT03114371|Drug|Oxytocin|Each patient will receive oxytocin in open label (Syntocinon® not reconditioned) from week 13 to week 24 according to the same dosages.
15969719|NCT03114358|Other|Early Carbapenem de-escalation|The intervention group is de-escalation carbapenems early within 24 hours or no later than 72 hours of prescription by ID specialist (early de-escalation).
15969720|NCT03114345|Other|Measurement of interface pressure|A capacitive pressure mapping device (XSensor) is set up on the patient air mattress bed. It records the interface pressure on the whole patient body with one frame every second during one hour. Then the file is saved and the pressure mapping device is removed from the patient hospital bedroom.
15969721|NCT03114345|Other|Measurement of micro-vascularization related parameters|A medical device called O2C, measuring micro-vascularization related parameters (oxygen saturation, hemoglobin quantity and blood flow) is used. The probe (= an optic fibre) is set up lightly on the patient skin or on a transparent adhesive for 1 minute. The median value of the local micro-vascularization parameters are saved on the O2C interface. The location of the measurement is chosen using the pressure mapping device to locate peak pressure area. Then the O2C is removed from the patient hospital bedroom.
15969722|NCT03114332|Procedure|Subcutaneous Drain|A closed drainage system for the subcutaneous tissue was used (Redivac) through a separate stab wound. Drains were left in place for 24 h or until drainage was less than 50 ml.
15969723|NCT03114319|Drug|TNO155|TNO155 for oral administration
15969724|NCT03114319|Drug|TNO155 in combination with EGF816 (nazartinib)|TNO155 for oral administration; EGF816 (nazartinib) for oral administration
15969725|NCT03114306|Procedure|local infiltration analgesia|Patient receive an infiltration of local anaesthetics around the knee directly after total knee replacement for postoperative pain control.
15969726|NCT03114306|Procedure|regional-anaesthesiological catheter analgesia|Patients receive a single shot nerve block of the proximal Nervus ischiadicus and a catheter placed closed to the Nervus saphenus for perioperative pain control using ultrasound guided techniques.
15969727|NCT03114293|Behavioral|Smartphone App|The app includes an EBPI and physical activity feedback
15969728|NCT03114280|Drug|TPF2|Combination drugs : docetaxel (T), cisplatin (P), 5 Fluorouracil (F) and pembrolizumab every 21 days
15969729|NCT03114280|Other|Radiotherapy with carboplatin|Radiotherapy (RT) combined with carboplatin
15969730|NCT03114267|Other|Comparison of the prevalences of the parvovirus genome|Comparison of the prevalences of the parvovirus genome between cases and controls and then of other viruses according to the results of parvoviruses and data from the literature
15969731|NCT03114254|Drug|Cabazitaxel|"Six cycles of chemotherapy comprising:
~Cabazitaxel 25mg/m2 to be repeated at intervals of 21 days."
15969732|NCT03114241|Behavioral|Intervention|Patients allocated to the intervention group receive a pedometer. They are encouraged to be more active by using the pedometer to measure the number of steps walked daily. An increase in step count of 15% compared to baseline will be set as the minimal goal for each patient. Monthly telephone calls are indicated to encourage compliance with the protocol and motivate patients to enhance their level of activity. The coached program ends after three months but patients keep their pedometer and are encouraged to sustain an increased level of daily physical activity for additional 9 months (end of study).
15969733|NCT03114228|Drug|Midostaurin|Midostaurin 50 mg (two 25 mg capsules) twice a day on days 8-21
15969734|NCT03114215|Drug|MD1003|capsules 100mg 3 times per day
15969735|NCT03114215|Drug|Placebo oral capsule|capsules 100mg lactose 3 times per day
15969736|NCT03114202|Other|intensive nutritional counseling|Individualised nutrition intervention in the form of regular and intensive nutrition counselling by a dietitian, following a predetermined standard nutrition protocol, the Medical Nutrition Therapy (Cancer/Radiation Oncology) protocol of the American Dietetic Association (ADA) every week during radiotherapy. Individually tailored sample meal plans, recipe suggestions and hints to minimise the side effects of the tumour and therapy will be provided.
15969737|NCT03114202|Other|Standard care|Nutritional counseling / education performed by hospital nurses and nutritional care performed by the hospital nutritionist.
15969738|NCT03114189|Procedure|footbath|
15969739|NCT03114189|Behavioral|care of sleep|
15969740|NCT03114176|Dietary Supplement|Ketogenic Diet|Diet consisted of a very low carbohydrate ketogenic diet (for 7 days) with the use of some phytoextracts as previously described. The consumed diet was primarily made of beef and veal, poultry, fish, raw and cooked green vegetables without restrictions, cold cuts (dried beef, carpaccio and cured ham), eggs and seasoned cheese (e.g., parmesan). The allowed drinks were infused tea, moka coffee and herbal extracts. The foods and drinks that subjects had to avoid included alcohol, bread, pasta, rice, milk, yogurt, soluble tea, and barley coffee. To facilitate adherence to the nutritional regime, a variety of special meals based on protein and fibers were given to each subject. KD characteristics are protein intake 1.3g/kg/day, to maintain skeletal muscle mass; carbohydrates intake less than 40 g/day and 50-60% of total kcal to induce ketosis. In accordance with a hypocaloric profile, total energy intake was calculated with 200 kcal more than basal metabolic rate.
15969741|NCT03114150|Behavioral|Cardiorespiratory fitness training|Physical exercise of moderate intensity designed to improve cardiorespiratory fitness
15969742|NCT03114150|Behavioral|Functional fitness training|Physical exercise of light intensity designed to improve functional fitness
15969743|NCT03114124|Device|MIFI Catheter|Multielectrode Catheter: standard ablation catheter that has the ability to record low and high frequency signals with high fidelity
15969744|NCT03114124|Device|Standard Ablation Catheter|Standard of care for patients with certain cardiac arrhythmias.
15969745|NCT03114111|Drug|aminolevulinic acid (ALA)|
15969746|NCT03114111|Drug|Placebo|
15969747|NCT03114098|Other|gene abnormalities|A salivary sample (2 ml sample) Blood sampling will be performed to assess treatment tolerance (6 ml)
15969748|NCT03114085|Drug|Capecitabine|Capecitabine 1000mg/m2 po bid, d1-d14, every 21 days for a cycle;
15969749|NCT03114085|Drug|Apatinib|Apatinib 500 mg po qd, d1-d21, every 21 days for one cycle
15969750|NCT03114072|Device|Blue-blocking glasses|Wear the BB-glasses from three hours before bedtime, and if needed to turn on the light, also during the night.
15969751|NCT03114072|Device|Light grey control glasses|Wear the light grey glasses from three hours before bedtime, and if needed to turn on the light, also during the night.
15969752|NCT03114059|Diagnostic Test|Glaucoma diagnostics|Heidelberg, Retinal Topography, Visual field, intraocular pressure, medication anamnesis, Retinal Nerve Fibre Layer Thickness, Pachymetry, Sonography, full ophthalmological determination
15969753|NCT03114046|Behavioral|Lower extremity Constraint-induced movement therapy(LE-CIMT)|"Both phases (A and B) will last 10 weekdays, and during baseline and treatment phases, the data will be collected on 5 different odd days. Considering the long period of data collection. During the baseline phase, no assessment will be administered on even days. The treatment will be delivered daily, along 10 weekdays, 3.5 hours per day. The motor training will be delivered during 3 hours and 30 minutes will be allocated to the administration of the TP.
~Both caregivers and participants will be individually interviewed before and after treatment."
15969754|NCT03114033|Other|Targeted therapeutic mild hypercapnia|Patients allocated to the TTMH protocol will be sedated to achieve moderate to deep sedation (a target Richmond Agitation Scale Score of -4). Arterial blood gases and end- tidal carbon dioxide levels will be measured at baseline and then used to guide respiratory rate adjustments of minute ventilation to remain within the target PaCO2 range of 50-55 mmHg. Arterial blood gases will be repeated every 4 hours for 24 hours following randomisation or if end-tidal carbon dioxide values change >5 mmHg
15969781|NCT03113851|Drug|rhGM-CSF|Patients were injected subcutaneously rhGM-CSF 125mg/m2 per day from day1 to day 14, every three weeks, concurrent with radiotherapy
15969782|NCT03113825|Device|Investigational Imaging device|Fluorescence imaging of the of the primary tumor specimen, any secondary breast specimens, and lymph nodes will be performed.
15969755|NCT03114033|Other|Targeted normocapnia (Standard care)|Patients allocated to the standard care (TN) protocol will be managed according to current practice and in accordance with ILCOR guidelines which recommend maintaining normocapnia in these patients. They will be sedated to achieve moderate to deep sedation (a target Richmond Agitation Scale Score of - 4). Arterial blood gases and end-tidal carbon dioxide levels will be measured at baseline and then used to guide respiratory rate adjustments of minute ventilation to remain within the target PaCO2 range of 35-45 mmHg. Arterial blood gases will be repeated every 4 hours for 24 hours following randomisation or if end-tidal carbon dioxide values change >5 mmHg.
15969756|NCT03114020|Drug|Hyaluronic Acid Inhalation Solution|twice a day 3 mL of 0.03% Hyaluronic Acid Inhalation Solution
15969757|NCT03114020|Drug|Placebo Inhalation Solution|Twice a day 3 ml of placebo inhalation solution
15969758|NCT03114007|Behavioral|Preventure program|Personality-targeted interventions conducted using manuals which incorporate psycho-educational, motivational enhancement therapy and cognitive-behavioural components. They include real life 'scenarios' shared by local youth with similar personality profiles. In the first session, participants are guided in a goal-setting exercise, designed to enhance motivation to change behaviour. Psycho-educational strategies are then used to teach participants about the target personality variable and associated problematic coping behaviours like avoidance, interpersonal dependence, aggression, risky behaviours and substance misuse.
15969759|NCT03114007|Behavioral|Equipe program|"Parent training program designed to be delivered in community settings accessible to large groups of parents of 13 to 18 year olds. It uses a coping modeling problem solving process in which parents are the key players in developing problem solving strategies.
~Parents participate in group workshops with themes related to communication, conflict resolution, cooperative transitions, negotiating, house rules, monitoring, consequences for serious problems and problem solving. Parents are guides to establish solutions to common problems. Readings and videotapes are used in the workshops to guide parents in identifying common challenges in child management, parenting errors, discussing possible consequences and alternative strategies as well as rationales supporting these strategies."
15969760|NCT03114007|Behavioral|Inter-Action services|An intervention model designed to provide integrated services for youth with significant symptoms of mental health problems, substance misuse and/or psychosocial difficulties. Young people with such difficulties will benefit from stepped and collaborative care involving interventions of varied intensity adapted to their needs and the severity of their problems. These will include cognitive behavioral therapy, motivational interviews, dialectic behavioral therapy and family interventions provided by multidisciplinary teams of professionals. A case navigator will be in charge of initiating service provision and ensuring a fast and smooth flow of information between indicated services providers.
15969766|NCT03113981|Device|Total Hip Arthroplasty|Implanting THA grafted with PolyNass or not
15969767|NCT03113968|Procedure|electroconvulsive therapy (ECT)|ECT is a procedure done under general anesthesia where small electric currents are passed through the brain, intentionally triggering a brief seizure. Patients who have not responded to antidepressant medications may be candidates for ECT. ECT is FDA approved for treatment resistant depression.
15969768|NCT03113968|Drug|Ketamine|Ketamine is a medication that is used as a short acting anesthetic in pediatric and adult medicine. Subanesthetic (low) doses will be given to patients via infusion in order to assess whether it helps with depression symptoms in patients who have not responded to antidepressant therapy. Ketamine is not FDA approved for this indication and its effectiveness in treatment resistant depression has not been proven. Prior studies have indicated that subanesthetic doses of ketamine may be helpful for treatment resistant depression.
15969769|NCT03113955|Device|Tandem Microsphere loaded with Epirubicin|The primary objective of this study is to evaluate the safety and efficacy of transcatheter arterial chemoembolization with Tandem Microspheres loaded with Epirubicin in the treatment of patients with localized hepatocellular carcinoma (HCC)
15969770|NCT03113942|Drug|Pomalidomide 2 MG Oral Capsule [Pomalyst]|Pomalidomide is an oral immunomodulatory derivative of thalidomide. Thalidomide and its derivatives are small molecules with broad effects on immune activation, including T-cell activation and responsiveness. Pomalidomide augments T cell responsiveness and proliferation by several mechanisms, many mediated by transcriptional regulation downstream of its primary target, cereblon. Effects include increased production of IL-2 and interferon-γ (IFN-γ), enhanced CD4+ and CD8+ T cell co-stimulation.
15969771|NCT03113929|Radiation|MRI|Research MRI
15969772|NCT03113916|Behavioral|Behavioural Lifestyle Intervention|A culturally tailored behavioral intervention.
15969773|NCT03113903|Behavioral|Psychophysical exploration|Psychophysical exploration (multimodal sensitivity, including pain sensitivity) Electronic von Frey applied on forearm; thermal heat applied on forearm; foot immersion in 2°C cold water; exposure to a one-frequency noise up to uncomfortable loudness ; exposure to a halogen-lamp-generated light up to uncomfortable brightness.
15969774|NCT03113890|Genetic|Phlebotomy - Folate|This will be a blood draw performed at Visit 1 for Folate (one 7mL tube)
15969775|NCT03113890|Genetic|Cheek Swab|Participants will undergo a cheek swab to then be analyzed using the Genecept Assay created by Genomind, Inc. This will occur once during Visit 1.
15969776|NCT03113890|Other|Self-report surveys|At visit 1 and at visit 3 and 4, participants will be asked to complete self report diagnostic surveys and surveys related to the objective aims of the study.
15969777|NCT03113877|Other|Autonomic Dysfunction Testing|The participants with CdLS will complete the COMPASS-31 survey and will complete standard clinical testing for autonomic dysfunction including an autonomic reflex screen (tilt table and quantitative sudomotor axon reflex testing) and thermoregulatory sweat test (TST).
15969778|NCT03113864|Dietary Supplement|Placebo|Daily supplementation for 9 months
15969779|NCT03113864|Dietary Supplement|Lutein|Daily Supplementation for 9 months
15969780|NCT03113851|Radiation|Radiotherapy|One lesion received radiotherapy for 35 Gy in 10 fractions and rested for one week; then another metastatic lesion were treated with radiotherapy for 35 Gy in 10 fractions.
15969786|NCT03113799|Device|Smart External Drain - SED|Subject will be treated on Day 2 with the SED. ICP and CSF volumes will be recorded at prespecified intervals while subject is stationary and while subject is engaged in protocol-driven directed movements.
15969787|NCT03113786|Other|CLARIX™100|CLARIX™100 is Amniox's processed and cryopreserved human amniotic membrane tissue retrieved from donated placental tissue after elective Cesarean Section delivery. Amniox's Amniotic Membrane is designated by the FDA as a tissue product under PHS 361 HCT/P (human cells, tissues and cellular and tissue-based products).
15969788|NCT03113786|Other|CLARIX CORD 1K|CLARIX CORD 1K is made from cryopreserved human umbilical cord, utilizing the patented CRYOTEK™ process. CLARIX CORD 1K is considered a Human Cells, Tissues & Cellular and Tissue-based product (HCT/P) by U.S. FDA standards.
15969789|NCT03113773|Drug|Proleukin|Patients will be treated with subcutaneous injections of IL-2 (range 0.3 X 10^6 - 3.0 X 10^6 IU) or placebo once daily for five consecutive days during the trial.A maximum dose of 3.0 X 10^6 IU will be allowed per day.
15969790|NCT03113773|Drug|Placebo Injection|Dextrose 5%
15969791|NCT03113760|Drug|Tadekinig alfa|Tadekinig alfa is a soluble glycoprotein of 164 amino acids produced from Chinese Hamster Ovary cell line. Tadekinig alfa is supplied as a colorless to slightly yellow, sterile solution for injection in glass vials containing sodium chloride, and 0.02M sodium phosphate buffer as excipients. It is available in a concentration of 20mg/0.5mL.
15969792|NCT03113760|Other|0.9% sodium chloride|To ensure that the treatment remains blinded for the entire study period, the placebo solutions will be supplied in identical vials and similar labelling as the active drug and will be indistinguishable in terms of their texture, color, and smell.
15969793|NCT03113747|Biological|ALLO-ASCs|1). Cryopreserved cell suspension of early passages of cultured allogeneic MSCs isolated from SVF obtained from lipoaspirate, a total of 10 mln. of cultured cells; 2).The TE-construct consisting of collagen- or fibrin-derived hydrogels and cells of early passages (up to P5) suspension of allogeneic cultured MSCs isolated from SVF obtained from lipoaspirate; Biological is applied by surface application over perforated (1:3) autologous skin graft following the covering with hypoadhesive bandage. This procedure is carried out twice - once simultaneously with a skin grafting procedure and 2-3 days following autodermoplasty, while bandaging.
15969794|NCT03113734|Other|Construction and validation of a functional score|"All patients will be treated at the same way:
~Completion of questionnaire by the physician with him. Once the consultation has been completed, the physician will issue prescriptions for the usual medical treatment, laximetry prescription (GNRB) to be performed when the knee is indolent and the prescription of the MRI to be performed .The physician will inform the patient that they should consult with the investigator's orthopedic surgeon once the results of GNRB and MRI are available.The study will end there for the patient. The surgeon will then follow his usual diagnostic procedure to decide on the future care of the patient."
15969795|NCT03113708|Drug|Heparin Sodium|Heparinisation 2-4 mg/kg will be done according to actual body weight or lean body weight.
15969796|NCT03113695|Drug|Obinutuzumab|obinutuzumab 1000 mg x 8 doses (first dose split on Cycle 1 days 1 100mg and 2 900mg; then day 8 and 15 of cycle 1; then day 1 of cycles 2-6, each cycle being 28 days long)
15969797|NCT03113695|Drug|lenalidomide|lenalidomide PO daily. The starting dose of lenalidomide is 5 mg PO daily. Starting on C2D1, the dose increases every 2 weeks in 5 mg increments to a maximum of 25 mg PO daily. Patients will continue lenalidomide until disease progression, unacceptable toxicity, or subsequent therapy.
15969798|NCT03113695|Drug|HDMP|methylprednisolone 1000 mg/m2 (ie HDMP) on days 1-5 of cycles 1-4
15969799|NCT03113682|Behavioral|CBT-RD|5-8 sessions of cognitive behavioral therapy for rumination disorder (CBT-RD), held once per week in an outpatient setting.
15969800|NCT03113669|Behavioral|CBT-GSH|
15969801|NCT03113656|Other|Weighted Blanket|Weighted blanket placed on infant for 30 minutes
15969802|NCT03113656|Other|Non-Weighted Blanket|Non-Weighted blanket placed on infant for 30 minutes
15969803|NCT03113643|Drug|Azacitidine|Chemotherapy
15969804|NCT03113643|Drug|SL-401|SL-401 works by targeting leukemia cells (blasts), and also possibly by stopping or slowing the growth of cancer stem cells, which are the undeveloped cells which can develop into cancer cells.
15969805|NCT03113643|Drug|Venetoclax|Venetoclax is a BH3-mimetic. Venetoclax blocks the anti-apoptotic B-cell lymphoma-2 (Bcl-2) protein, leading to programmed cell death of CLL cells. Overexpression of Bcl-2 in some lymphoid malignancies has sometimes shown to be linked with increased resistance to chemotherapy.
15969806|NCT03113630|Device|Acquisition on TouchScreen|Participants performed acquisition and retention on TouchScreen, transfer 1 on Kinect and transfer 2 on LeapMotion.
15969807|NCT03113630|Device|Acquisition on Kinect|Participants performed acquisition and retention on Kinect, transfer 1 on TouchScreen and transfer 2 on LeapMotion.
15969808|NCT03113630|Device|Acquisition on LeapMotion|Participants performed acquisition and retention on LeapMotion, transfer 1 on TouchScreen and transfer 2 on Kinect.
15969809|NCT03113630|Device|Acquisition on TouchScreen Control Group|Participants performed acquisition and retention on TouchScreen, transfer 1 on Kinect and transfer 2 on LeapMotion.
15969810|NCT03113630|Device|Acquisition on Kinect Control Group|Participants performed acquisition and retention on Kinect, transfer 1 on TouchScreen and transfer 2 on LeapMotion.
15969811|NCT03113630|Device|Acquisition on LeapMotion Control Group|Participants performed acquisition and retention on LeapMotion, transfer 1 on TouchScreen and transfer 2 on Kinect.
15969812|NCT03113617|Procedure|Computed Tomography|Undergo PET/CT
15969813|NCT03113617|Drug|Gallium Ga 68-labeled GRPR Antagonist BAY86-7548|Given IV
15969814|NCT03113617|Other|Laboratory Biomarker Analysis|Correlative studies
15969815|NCT03113617|Procedure|Positron Emission Tomography|Undergo PET/CT
15969816|NCT03113604|Other|Study on samples of tumor and peri-tumor tissues from patients with hepatocellular carcinoma|"Retrospective study of samples of tumor and peri-tumor tissues from patients with hepatocellular carcinoma (HCC): three groups of samples will be selected:
~Group 1: Tumor and peri-tumor tissue samples from patients with non-treated sorafenib CHC (surgical resection or other) Group 2: Tumor and peri-tumor tissue samples from tumor and peritumor tissues of patients not responding to sorafenib treatment Group 3: samples from patients responding to treatment with sorafenib"
15969817|NCT03113591|Procedure|Minimum invasive total hip arthroplasty|Minimum invasive total hip arthroplasty using the osteo introducer system
15969818|NCT03113591|Procedure|Common total hip arthroplasty|Common total hip arthroplasty using common instruments
15969819|NCT03113578|Device|DiLumen|The study device is placed over a compatible endoscope to facilitate endoscopic diagnosis and treatment of any large intestine pathology with the use of double balloons
15969820|NCT03113565|Behavioral|Count daily number of footsteps.|Using a connected electronic wristband to mainly quantify daily number of footsteps.
15969821|NCT03113539|Other|Modified Low-dose, EKG-gated CT without contrast for the evaluation of aortic aneurysm|"On the same day, the subject will do :
~Modified low-dose, EKG-gated CT without contrast
~Usual high-dose, EKG-gated CT with contrast
~Comparing aortic diameters from the two protocols."
15969822|NCT03113526|Procedure|remove drain|remove drain when output is less than 30ml or less than 100ml per 24-hour
15969823|NCT03113513|Procedure|fixation of the vaginal apex|In the course of vaginal hysterectomy the vaginal cuff is either fixed to the sacrospinous ligament or to the uterosacral ligament.
15969824|NCT03113500|Drug|Brentuximab Vedotin|Given IV
15969825|NCT03113500|Drug|Cyclophosphamide|Given IV
15969826|NCT03113500|Drug|Doxorubicin|Given IV
15969827|NCT03113500|Drug|Doxorubicin Hydrochloride|Given IV
15969828|NCT03113500|Drug|Etoposide|Given IV
15969829|NCT03113500|Drug|Etoposide Phosphate|Given IV
15969830|NCT03113500|Other|Laboratory Biomarker Analysis|Correlative studies
15969831|NCT03113500|Drug|Prednisone|Given PO
15969832|NCT03113487|Biological|Modified Vaccinia Virus Ankara Vaccine Expressing p53|Given SC
15969833|NCT03113487|Biological|Pembrolizumab|Given IV
15969834|NCT03113474|Other|Food palatability|Food palatability is modulated
15969835|NCT03113461|Device|CPAP|non-invasive positive airway pressure applied using an oronasal mask
15969836|NCT03113448|Drug|0.075% Capsaicin Lotion|To apply 3-4 times per day, every day until 8 weeks then stop
15969837|NCT03113448|Drug|placebo|To apply 3-4 times per day, every day until 8 weeks then stop
15969838|NCT03113435|Other|Oxygen consumption optimization|hemodynamic stability will be achieved through exploration of oxygen consumption need of the patient based on CO2gap/CaO2-CvO2 ratio
15969839|NCT03113422|Drug|Induction Venetoclax|"1 cycle = 28 days.
~Cycle 1-6: Obinutuzumab IV. Cycle 1, Day 1 obinutuzumab 100 mg and Cycle 1, Day 2 obinutuzumab 900 mg for total dose of 1000 mg. On Cycle 1, Day 8 and Day 15 obinutuzumab 1000 mg. Starting with Cycle 2, obinutuzumab 1000 mg on Day 1 only of each cycle.
~Cycle 1-6: Bendamustine 90 mg/m² IV on Days 1 and 2 of each cycle over 15 minutes after obinutuzumab.
~Cycle 2-6: Venetoclax 800 mg by mouth daily on Days 1-10 administered before obinutuzumab and/or bendamustine."
15969840|NCT03113422|Drug|Maintenance Venetoclax|Patients whose disease is the same or improved will receive venetoclax 800 mg by mouth daily for 24 cycles (1 cycle=1 month) and obinutuzumab 1000 mg IV every 2 months for 12 cycles. Patients with no evidence of disease will receive obinutuzumab 1000 mg IV every 2 months for 12 cycles.
15969841|NCT03113409|Drug|Buprenorphine|Buprenorphine will be administered daily
15969842|NCT03113409|Drug|Naltrexone|On study day 2, participants will receive increasing doses of oral naltrexone prior to administration of XR-NTX
15969843|NCT03113409|Drug|Vivitrol|Participants will receive one 380 i.m. injection on Study day 5 or 10, and another injection 4 weeks later.
15969844|NCT03113396|Drug|Baclofen|baclofen oral, 10mg, tid for 2 weeks (or placebo, identically looking capsules) after 2 weeks, patients undergo a High Resolution Impedance Manometry measurement with a meal period. Patients will fill out questionnaires concerning overall wellbeing.
15969845|NCT03113396|Drug|Placebo oral capsule|placebo oral, tid for 2 weeks after 2 weeks, patients undergo a High Resolution Impedance Manometry measurement with a meal period. Patients will fill out questionnaires concerning overall wellbeing.
15969846|NCT03113383|Device|Thoracoabdominal Aortic Aneurysm Repair|Thoracoabdominal aortic aneurysm repair
15969847|NCT03113370|Dietary Supplement|Fish Oil|Fish Oil capsules
15969848|NCT03113370|Dietary Supplement|Placebo|Olive Oil
15969849|NCT03113357|Other|Myofascial release technique|myofascial release technique take along about 3 minutes. This phase repeated 3 times in each session. At the end, for more release, sub-occipital traction will commence. The subject lies supine with head supported and therapist places the three middle fingers just caudal to the nuchal line, lifts the finger tips upward resting the hands on the treatment table, and then applies a gentle cranial pull, causing a long axis extension. The procedure is performed for 2 to 3 minutes. Subjects in each group received ten physical therapy treatment sessions. Treatment frequency was six times per week for MFR group and every day for exercise group which three times per week have been come to clinical center for checking of exercise by physiotherapist
15969850|NCT03113357|Other|conventional exercise therapy|"All exercises were performed to a count of 7 seconds and subjects were instructed to perform all exercises daily, 15 repetitions each (twice a day). Treatment frequency was every day for exercise group which three times per week have been come to clinical center for checking of exercise by physiotherapist. They also could be taught active muscle stretching exercises to address any muscle tightness assessed to be present."
15969851|NCT03113344|Drug|cephalosporins,penicillins,macrolides,carbapenems and antiviral drugs|According to the models of population pharmacokinetics,the investigators and want to correlate use of antibiotics with treatment effectiveness and safety in children.
15969852|NCT03113318|Procedure|Total mediastinal lymph node dissection and pulmonary metastasectomy|Total mediastinal lymph node dissection where all lymph nodes and fatty tissues is removed conjunction with pulmonary metastasectomy
15969853|NCT03113318|Procedure|Only pulmonary metastasectomy|
15969854|NCT03113292|Other|Pilates|"The protocol will be composed by the following exercises, structured in each session according to progression, difficulty and focus (respiration, stability, muscle strength and joint mobility): Arm Arcs, Bent Knee Opening, Sidelying, Dead Bug, Femur Arcs, Quadruped Series, Single Leg Stretch, Prone Press Up, Sidekick (Front to Back 1 e 2), Leg Pull Front, Mermaid, Spine Stretch, The Hundred, Pelvic Clock, Bridging, Stanging Roll Down, Swan, Saw, Dart, Swimming, Book Opening.
~."
15969855|NCT03113292|Other|Home Exercises|The protocol will be divided into 3 phases, each one composed by the following exercises and structured according to difficulty progression and focus (postural reeducation, muscle strength, balance, joint flexibility): Muscle strength exercises composed by abdominal exercises; back extension exercises; gluteus maximus exercises. Stretching exercises for the lower back, pelvis, iliopsoas muscle, tensor fascia latae muscle).
15970416|NCT03109262|Procedure|Single-photon emission computerized tomography (SPECT) scan|As part of SPECT/CT scan
15969856|NCT03113266|Biological|humanized anti-PD-1 monoclonal antibody toripalimab|humanized anti-PD-1 monoclonal antibody (JS001) is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically.
15969857|NCT03113253|Drug|Tranexamic Acid|
15969858|NCT03113253|Drug|Placebo|0.9% sodium chloride to mimic tranexamic acid
15969859|NCT03113240|Drug|Glutamin|Enteral Glutamine 0.3g/kg/day powdered glutamine to be mixed in with water and given via nasogastric tube q4 hrs.
15969860|NCT03113240|Other|Maltodextrin|Maltodextrin mixed with water given via NG tube q 4 hours.
15969861|NCT03113227|Diagnostic Test|Transvaginal ultrasound|Transvaginal ultrasound will be made for assessment of posterior cervical angle and cervical length
15969862|NCT03113227|Diagnostic Test|Vaginal examination|Vaginal examination will be done for assessment of Bishop score
15969863|NCT03113214|Radiation|radiochemotherapy 1|concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 7.2 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2, weekly; paclitaxel, 45-50 mg/m2, weekly
15969864|NCT03113214|Radiation|radiochemotherapy 2|concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT;
15969865|NCT03113214|Radiation|radiochemotherapy 3|concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 21.6 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT;
15969866|NCT03113214|Radiation|radiochemotherapy 4|concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 28.8 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT;
15969867|NCT03113214|Radiation|radiochemotherapy 5|concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 36 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT;
15969868|NCT03113214|Radiation|radiochemotherapy 6|concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 43.2 Gy at 1.2 Gy/Fx/bid to residual tumor volume as defined by PET/CT;
15969869|NCT03113201|Behavioral|Collaborative care|Collaborative care provided by the general practitioner and the care manager. Treatment modalities: Cognitive-behavior Therapy, psychoeducation and medication according to a stepped care model
15969870|NCT03113201|Behavioral|Consultations-Liaison|Consultation-Liaison provided by general practitioner involving a educational relationship with the Collabri Flex team (care manager and psychiatrist).
15969871|NCT03113188|Drug|CBP501|CBP501, CDDP plus Nivolumab
15969872|NCT03113175|Behavioral|Collaborative care|Collaborative care provided by the general practitioner and the care manager. Treatment modalities: Cognitive-behavior Therapy, psychoeducation, medication according to a stepped care model
15969873|NCT03113175|Behavioral|Consultations-Liaison|Consultation-Liaison provided by general practitioner involving a educational relationship with the Collabri Flex team (care manager and psychiatrist).
15969874|NCT03113162|Biological|Autologous Hematopoietic Stem Cell|
15969875|NCT03113162|Drug|BEAM Regimen|Reduced-intensity BEAM for Immunoablation
15969876|NCT03113136|Behavioral|Low wattage E cigarette device|The low wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
15969877|NCT03113136|Behavioral|HIgh wattage E cigarette device|The high wattage E cigarette device will be provided to the participant and they will be instructed to vape ad libitum for 12 weeks and then be assessed at 6 months and 12 months for continued use of device.
15969878|NCT03113136|Behavioral|Usual brand cigarette|The usual brand of cigarettes will be provided to the participant and they will be instructed to smoke ad libitum for the duration of the study.
15969879|NCT03113123|Drug|PrEP with Truvada®|"Associated with:
~STD screening/treatment for syphilis, gonorrhoea and chlamydiae
~HIV screening/therapy
~Questionnaire
~Addiction, social or psychological follow-up care if needed
~Peer interactive counselling (peer counselors/nurses/physicians experienced with therapeutic education) at the baseline visit and at every follow-up visit up to 6 months. After 6 months, counselling will be provided at the request of participants if they need it. Counselors will remain in contact with the participants between visit to answer any questions relative to PrEP, treatment and prevention, and to facilitate participants interactions with study sites."
15969880|NCT03113110|Drug|Empagliflozin 10 mg|PTDM patients on previous antidiabetic treatment (<40 IU insulin (in some cases plus oral antidiabetics)) receive Empagliflozin, ideally as monotherapy
15969881|NCT03113097|Other|Embryo transfer|Transfer of different qualities of embryos at blastocyst stage
15969882|NCT03113084|Biological|Sodium Heparin UQ subcutaneous drug administration|The participants will be hospitalized one day to receive the Sodium heparin UQ experimental medication or Sodium heparin FK comparator medication. They will receive the Subcutaneous medication and start the blood collection at the programmed time. After 7 days, the participants will return to receive the other medication and have their blood collected. The last visit will be to collect safety datas
15969883|NCT03113084|Biological|Sodium Heparin FK subcutaneous drug administration|The participants will be hospitalized one day to receive the Sodium heparin FK comparator medication or Sodium heparin UQ experimental medication. They will receive the subcutaneous medication and start the blood collection at the programmed time. After 7 days, the participants will return to receive the other medication and have their blood collected. The last visit will be to collect safety datas
15969884|NCT03113071|Drug|Decitabine|Decitabine will be administered in combination with Digoxin
15969885|NCT03113071|Drug|Digoxin|Decitabine will be administered in combination with Digoxin
15969886|NCT03113058|Combination Product|Adoptive transfer of γδT cells|Patients are treated via intravenous infusion of in vitro-activated allogeneic γδ Tcells every two weeks, 12 times in total (6 months).
15969887|NCT03113045|Other|seated time|Pt will be seated for a predetermined time period. All Patients will receive intrathecal bupivacaine and morphine.
15969944|NCT03112603|Drug|mechanistic Target of Rapamycin (mTOR) inhibitors (everolimus or sirolimus)|Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.
15970727|NCT03106805|Procedure|late insertion|insertion at 6th postpartum week
15969888|NCT03113032|Other|P-SEC Pre-Surgical Care|The P-SEC protocol is designed to deliver a focal mode of exercise-conditioning for motor performance to the knee extensor musculature. The latter requires a brief, machine-based gravity-resisted joint' movements (<2 seconds). An exercise session (6-minutes, approximately) will require a patient to undertake 4 sets of movement, with sets separated by 60-seconds recovery (delivering a total of 36 exercises across 3 interspersed days).
15969889|NCT03113032|Other|Normal pre-surgical care|Routine pre-surgical care
15969890|NCT03113019|Biological|Immunotherapy based on dendritic cells|Intravenous injection of cells
15969891|NCT03113006|Procedure|Panretinal Photocoagulation|Panretinal laser treatment of the retina in patients with proliferative diabetic retinopathy.
15969892|NCT03112993|Drug|sugammadex|once at the end of the surgery
15969893|NCT03112993|Drug|Neostigmine|once at the end of the surgery
15969894|NCT03112980|Device|Transcatheter aortic valve implantation|(TAVI)
15969895|NCT03112980|Procedure|Surgical aortic valve replacement|(SAVR)
15969896|NCT03112967|Other|low-volume preparation, oral sulfate solution|Oral Sulfate solution (Suprep) in day before and split-dose regimens In the OSS arm: between 17:00 and 18:00 hours on the day before colonoscopy, subjects were instructed to pour one 180-ml bottle of the study medication into a provided 480-ml mixing cup and fill it with water and then drink the entire volume, followed by two additional 480 ml of water. At approximately 6:00 a.m. on the following morning, the subjects took the second dose of OSS by same formulation protocol.
15969897|NCT03112967|Other|large-volume preparation, 4L polyethylene glycol|4L PEG solution in day before and split-dose regimens In the 4L PEG arm: subjects had the first 2L between 18:00 and 19:00 hours (250mL every 15 minutes) in the evening before the colonoscopy. And the second 2L was given between 07:00 and 08:00 on the day of colonoscopy.
15969898|NCT03112954|Drug|Buccal-relaxant formula|Following physical examinations, 60 patients were randomly allocated to 2 groups of 30 patients each, who had been diagnosed with sleep bruxism. Each patient received a small amber glass bottle containing the floral remedy and was instructed to use four drops sublingually 4 times a day for 22 days. All examiners were different professionals, with no contact among each other, as follows: an examiner who conducted the physical examination, an examiner who randomly divided the patients, and an examiner who prepared the floral and placebo remedies. At the end of the study, each group of 30 patients was re-named: Group F, the group of patients who received the floral remedy.
15969899|NCT03112954|Drug|Placebo|30 patients diagnosed with sleep bruxism received a small amber glass bottle containing the saline solution and was instructed to use four drops sublingually 4 times a day for 22 days. All examiners were different professionals, with no contact among each other, as follows: an examiner who conducted the physical examination, an examiner who randomly divided the patients, and an examiner who prepared the floral and placebo remedies. At the end of the study, each group of 30 patients was re-named: Group P, the group of patients who received the placebo.
15969900|NCT03112941|Procedure|control group|Patients with traumatic incomplete spinal cord injury (SCI) in the control group are treated with pedicle screw fixation and decompressive laminectomy.
15969901|NCT03112941|Other|hyperbaric oxygen group|Patients with traumatic incomplete spinal cord injury (SCI) in the hyperbaric oxygen group are treated with pedicle screw fixation and decompressive laminectomy, and are given 0.2 MPa hyperbaric oxygen (HBO), once a day, 10 times as a course, with 5-7 days of resting between two courses, totally four courses.
15969902|NCT03112928|Device|Phantom Motor Execution|"Neuromotus - PME decodes motor volition applying machine learning to surface electromyography. Once the intention of movement is known, this is use to control serious games in virtual and augmented reality.
~A treatment session of MPE consists of:
~Pain evaluation
~Placement of the electrodes and fiducial marker
~Practice of motor execution in Augmented Reality (AR)
~Gaming using phantom movements
~Practice of motor execution by matching random target postures of a virtual limb.
~Step 3 to 4 are repeated for different phantom joints, initially one at the time progressing to several joints simultaneously. A treatment session last 2 hours."
15969903|NCT03112928|Device|Phantom Motor Imagery|The only difference between PME and PMI is that in the former myoelectric signals are used to give the participants control over the virtual environments, whereas in PMI the presence of myoelectric activity is used as an alarm to remind the participant that it must imagine rather than execute the phantom movement. In PMI the virtual environments act autonomously to guide the participant in imagination of movement.
15969904|NCT03112915|Procedure|quadratus lumborum block|QLB: Quadratus lumborum block : 20 mL of 0.25% bupivacaine will be administered between the quadratus lumborum and the psoas major muscle bilaterally in the lateral decubitus position
15969905|NCT03112915|Procedure|Transversus abdominis plan block|TAP: transversus abdominis plan block: 20 mL of 0.25% bupivacaine will be administered between the internal oblique muscle and the transversus abdominis muscle bilaterally in the supine position
15969906|NCT03112902|Device|Application of Transcranial Alternating Current Stimulation for Modulation of Sleep and Cognitive Performance|Transcranial Alternating Current Stimulation will be applied during slow wave sleep to assess effects on memory and sleep architecture.
15969907|NCT03112889|Drug|Sodium Valproate|Subjects will receive sodium valproate modified release 20mg/kg/day (maximum dose 2.0g/day) administered orally once daily for six months.
15969908|NCT03112876|Other|Skin Surface Lipid Collection and Skin Barrier Function|All five groups will undergo the same study intervention: skin surface lipid collection via tapes and skin barrier function evaluated with non-invasive painless devices.
15969909|NCT03112863|Drug|Bakuchiol|This group will receive bakuchiol
15969910|NCT03112863|Drug|Retinol|This group will receive retinol
15969911|NCT03112850|Device|Hearing aid|LOF hearing aid
15969912|NCT03112850|Behavioral|Auditory Training|
15969913|NCT03112837|Other|Lactobacillus, Bifidobacterium and Enterococcus|3 pills two times a day during the whole treatment
15969914|NCT03112824|Drug|Ashwagandha Root Extract Capsule|Participants will take one 300 mg capsule of Ashwagandaha Root Extract orally twice a day for 12 weeks.
15969915|NCT03112824|Drug|Placebo Capsule|Participants will take one placebo capsule orally twice a day for 12 weeks.
15969916|NCT03112811|Device|Autogenic drainage|The manual technique of the chest physiotherapy to move the secretions
15969917|NCT03112811|Device|Intrapulmonary percussive ventilation|The instrumental technique of the chest physiotherapy to move the secretions
15969918|NCT03112785|Device|Total hip arthroplasty (Fitmore or CLS uncemented femoral stem made by Zimmer-Biomet, Warshaw, USA)|The most symptomatic side is randomised to one of the two stem types studied. If the patient has equal amount of symptoms on both sides, the one with most pronounced degenerative Changes on plain radiographs will be randomised. On the second side the type of stem not used on the first one will be inserted. All patients and allhip will receive the same type and design of cup.
15969919|NCT03112772|Other|Puros® Allograft|It is a type of bone grafting materials used for enhancing bone formation
15969920|NCT03112772|Other|CopiOs® Cancellous Particulate|It is a type of bone grafting materials used for enhancing bone formation
15969921|NCT03112759|Behavioral|Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT) uses pain coping skills as a method of managing symptoms associated with chronic pain.Cognitive behavioral therapy teaches patients to identify and modify negative thoughts and behaviors that increase pain intensity, distress, and pain-related disability
15969922|NCT03112746|Behavioral|Cognitive Orientation to Daily Occupational Performance|In CO-OP Approach, therapists use mediational techniques to teach cognitive strategies - GOAL, PLAN, DO, CHECK - to improve occupational performance in goals chosen by the children in collaboration with them and their parents.
15969923|NCT03112733|Diagnostic Test|TFF3, SFRP4, Romo1, NFKB|Blood samples of all participants will be collected.
15969924|NCT03112720|Device|Epidural Blood Patch|A device: 17 gauge Tuohy needle will be placed to the epidural space using the loss of resistance technique. Once positioned a sterile stylet will be replaced within the needle to maintain the sterility of the epidural space. A tourniquet may be used to identify a peripheral venous site, which will be sterilely prepped with betadine x3 and then chloraprep. Venipuncture will be performed with a device: 20gauge or larger needle. 20mL of blood will be aspirated in a sterile system into an appropriately sized syringe. After sterile transfer, this autologous blood will be slowly injected into the epidural space.
15969925|NCT03112720|Drug|Sphenopalatine Ganglion Block|The drug: 5% lidocaine ointment, a local anesthetic, will be applied to the end of a device: long channeled cotton tipped applicator inserted into both nares and placed over the mucosa in the area of posterior aspect of the middle ethmoid, toward the presumed anatomic location of the sphenopalatine ganglion, evidenced by a slight resistance at the appropriate depth. 5mL of drug: 1% lidocaine solution will then be injected into the hollow shaft of the device: applicator and allowed to topically anesthetize the ganglion by gravity flow for 30 minutes.
15969926|NCT03112707|Drug|Aspirin|After percutaneous coronary intervention with bioresorbable polymer-coated everolimus-eluting Synergy® stent implantation, dual antiplatelet therapy with aspirin 100 mg od and a P2Y12 inhibitor will be continued for a duration of 1 month, after which single antiplatelet therapy with aspirin will be recommended indefinitely. In case of need for oral anticoagulation, patients will receive an oral anticoagulant in addition to a P2Y12 inhibitor without aspirin for 30 days.
15969927|NCT03112707|Drug|P2Y12 inhibitor|After percutaneous coronary intervention with bioresorbable polymer-coated everolimus-eluting Synergy® stent implantation, dual antiplatelet therapy with aspirin 100 mg od and a P2Y12 inhibitor will be continued for a duration of 1 month, after which single antiplatelet therapy with aspirin will be recommended indefinitely. In case of need for oral anticoagulation, patients will receive an oral anticoagulant in addition to a P2Y12 inhibitor without aspirin for 30 days.
15969928|NCT03112694|Other|Data collection|This is a non-interventional study, the decision to prescribe the product would have been taken prior to, and independently from the decision to enrol the patient.
15969929|NCT03112681|Drug|Saroglitazar magnesium 2 mg|Saroglitazar magnesium 2 mg once daily in the morning before breakfast without food, for a period of 16 weeks.
15969930|NCT03112681|Drug|Saroglitazar magnesium 4 mg|Saroglitazar magnesium 4 mg once daily in the morning before breakfast without food, for a period of 16 weeks.
15969931|NCT03112681|Drug|Placebo Oral Tablet|Placebo once daily in the morning before breakfast without food, for a period of 16 weeks.
15969932|NCT03112668|Behavioral|Cognitive Behavior Therapy|Undergo ACT
15969933|NCT03112668|Other|Quality-of-Life Assessment|Ancillary studies
15969934|NCT03112668|Other|Questionnaire Administration|Ancillary studies
15969935|NCT03112668|Other|Survey Administration|Ancillary studies
15969936|NCT03112655|Diagnostic Test|RNA and neopterin detection|Detection of spliced leader RNA will be performed on blood and cerebrospinal fluid taken before treatment, 11 days after treatment, 6, 12 and 18 months after treatment. Neopterin and 5-hydroxytryptophan will be quantified in cerebrospinal fluid taken at the same time points.
15969937|NCT03112642|Procedure|Local anesthetic block [0.35% marcaine]|In the absence of paresthesia and after negative aspiration, the 40 ml of local anesthetic block [0.35% marcaine] will be administered.
15969938|NCT03112642|Device|Braun DIG-R-C Stimuplex Blockade Monitor System|The blockade system will be initially set at 1 milliamp. As the proximity of the tip of the needle to the components of the brachial plexus becomes evident by ultrasound approximation and the stimulation pattern of the hand and wrist, the output of the system will be reduced to .3-.5 milliamps. With use of the Braun DIG-R-C Stimuplex Blockade Monitor System.
15969939|NCT03112616|Other|Vibration sessions|The patients will undergo a program of 10 sessions of vibrations of the neck muscle, each of 10 minutes, during a period of 15 days at the rate of one session per day.
15969940|NCT03112603|Drug|Ruxolitinib|Ruxolitinib twice daily at the protocol-defined starting dose.
15969941|NCT03112603|Drug|Extracorporeal photopheresis (ECP)|Best available therapy (BAT) will be selected by the investigator for each participant. BAT may not include experimental agents (ie, those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements. The BAT in this study will be among the following treatments currently used in this setting (no other types or combinations of BATs are permitted in this study).
15969942|NCT03112603|Drug|Low-dose methotrexate (MTX)|Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.
15969943|NCT03112603|Drug|Mycophenolate mofetil (MMF)|Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.
15970062|NCT03111836|Behavioral|Expert-Driven Group|The user-driven e-Counselling group will receive a lifestyle program where the user are able to choose areas of focus. All subjects will be sent 16 e-messages on a weekly schedule.
15969945|NCT03112603|Drug|Infliximab|Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.
15969946|NCT03112603|Drug|Rituximab|Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.
15969947|NCT03112603|Drug|Pentostatin|Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.
15969948|NCT03112603|Drug|Imatinib|Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.
15969949|NCT03112603|Drug|Ibrutinib|Patients will receive BAT based on the Investigator's opinion, taking into account the manufacturer's instructions, labeling, subject's medical condition, and institutional guidelines for any dose adjustment.
15969950|NCT03112590|Biological|Interferon-gamma (IFN-γ)|Phase 1: IFN-γ 50 or 75 mcg/m^2 SQ x 3 days/week for 12 weeks. Phase 2: IFN-γ at Recommended Phase II Dose (RP2D) subcutaneously (SQ) x 3 days/week, for 12 weeks.
15969951|NCT03112590|Drug|Paclitaxel|Phase 1 and Phase 2: Paclitaxel 80 mg/m^2/week, for 12 weeks.
15969952|NCT03112590|Drug|Trastuzumab|Phase 1 and Phase 2: Trastuzumab 8 mg/kg intravenous (IV) loading dose on cycle 1/day 1 (C1D1), followed by 6 mg/kg on subsequent cycles every 3 weeks, for 12 weeks.
15969953|NCT03112590|Other|Pertuzumab|Phase 1 and Phase 2: Pertuzumab 840 mg IV loading dose on C1D1, followed by 420 mg on subsequent cycles every 3 weeks, for 12 weeks.
15969954|NCT03112590|Procedure|Post Therapy Surgery|Phase 2: Participants will be assessed for surgery following the fourth cycle of study therapy (or earlier if study treatment is cancelled due to unmanageable side effects).
15969955|NCT03112577|Drug|REGN3500|Intravenous (IV) use
15969956|NCT03112577|Drug|Dupilumab|Subcutaneous (SC) use
15969957|NCT03112577|Drug|Placebo|Matching placebo
15969958|NCT03112577|Drug|Fluticasone propionate|Inhalation use
15969959|NCT03112564|Other|Avoidance of rocuronium/cisatracurium|Anesthesia induction was performed at tidal volume, avoiding the use of analgesics and/or muscle relaxants with FGF of 6 L/min. Induction time was shortened as the FGF was increased. Once 5% sevoflurane end-tidal volume was reached, ventilation with facial mask was maintained for three more minutes. The time lapsed until the loss of blink reflex was achieved and orotracheal tube (OTT) was placed, difficulties in OTT placement, sevoflurane end-tidal volume after OTT placement, complications related to OTT insertion (movement, coughing, rigidity, apnea), mean arterial pressure (MAP) variations were measured. No muscle relaxants were given during surgery.
15969960|NCT03112564|Drug|Sevoflurane 8% + Intravenous fentanyl|Sevoflurane 8% + Intravenous fentanyl was the regimen used for induction and maintenance of anesthesia
15969961|NCT03112551|Drug|Adminstration of magnesium Sulphate for treatment of eclampsia|A total of 100 eclamptic patients are suspected to be approached alternately and subcategorized into two groups - one group will be treated with 24 hours maintenance dose of magnesium sulphate (Group-1; n=50), and the other with 12 hours maintenance dose of magnesium sulphate (Group-2; n=50).
15969962|NCT03112538|Device|Insulin Pump|Medtronic Minimed Paradigm Veo Insulin Pump
15969963|NCT03112538|Drug|Multiple daily injections of insulin|Multiple daily injections which consist of a single injection of basal insulin(insulin Glargine) and 3 injections of bolus insulin(rapid acting insulin Glulisine or Aspart) before each meal
15969964|NCT03112525|Diagnostic Test|CYP3A4/5 and P-gp phenotyping|Phenotyping using a simplified version of the Geneva cocktail
15969965|NCT03112525|Genetic|CYP3A4/5 and P-gp genotyping|Selected CYP3A4, CYP3A5, CYP3A7 and ABCB1 single nucleotide polymorphism (SNP) determination
15969966|NCT03112512|Device|optimal PEEP guided by EIT|Patients are randomly assigned to EIT group or G5 group. PEEP selected in EIT group is based on GI index and regional compliance. PEEP decided in G5 group is based on the ventilator.
15969967|NCT03112512|Device|optimal PEEP guided by G5 ventilator|Patients are randomly assigned to EIT group or G5 group. PEEP selected in EIT group is based on GI index and regional compliance. PEEP decided in G5 group is based on the ventilator.
15969968|NCT03112499|Procedure|PCNL|Under general anesthesia and patient in prone position, with the use of a flexible cystoscope an open-ended ureteral catheter 5F / 70cm is positioned to the proximal ureter. Retrograde pyelography is performed and the most appropriate calyx is accessed with the use of ultrasound, under fluoroscopic guidance. A 0.035 guide wire is inserted into the ureter and then replaced with an extra stiff wire. Using either balloon (20 atm) or Amplatz serial dilators a 30F access channel is created. Lithotripsy is performed using ultrasound lithotripter and stone fragments are removed by grasping forceps. At the end of the operation a 18F Council type catheter is placed into the kidney for drainage of urine and an indwelling JJ catheter is inserted in the ipsilateral ureter. Council and JJ catheter are removed,in the absence of complications, the second and tenth postoperative day, respectively.
15969969|NCT03112499|Procedure|mini-PCNL|Under general anesthesia and patient in prone position, with the use of a flexible cystoscope an open-ended ureteral catheter 5F / 70cm is positioned to the proximal ureter. Retrograde pyelography is performed and the most appropriate calyx is accessed with the use of ultrasound, under fluoroscopic guidance. A 0.035 guide wire is inserted into the ureter and then replaced with an extra stiff wire. Using Amplatz serial dilators a 16F access channel is created. Lithotripsy is performed using using 270mm Ho: YAG laser fiber and stone fragments are removed by grasping forceps. At the end of the operation a 10F nephrostomy tube is placed into the kidney for drainage of urine and an indwelling JJ catheter is inserted in the ipsilateral ureter. Nephrostomy tube and JJ catheter are removed, in the absence of complications, the second and tenth postoperative day, respectively.
15969970|NCT03112499|Procedure|RIRS|Under general anesthesia and patient in lithotomy position, a 0.035 hydrophilic safety wire is inserted in the ureter under fluoroscopic guidance. Subsequently 8-10 F dilators are used for dilation of the ureter.Insertion of a second working wire follows above which a 14F ureteral sheath is placed. Lithotripsy with a flexible ureteroscope using 270mm Ho: YAG laser fiber follows.Remaining stone fragments are removed by a 2,2F nitinol basket. At the end of the operation a JJ indwelling ureteral catheter is placed over the safety wire. Discharge is performed in the absence of complications, the first postoperative day while JJ catheter is removed on the 10th postoperative day.
15969971|NCT03112486|Procedure|blood draw|Blood draws will be collected via venipuncture or IV at hours 0, 6, 12, 18, 24, 48, 72, 96, 120, 144 (10 draws total). Each draw would be approximately 20 mL of blood (but no less than 10 mL).
15969972|NCT03112473|Behavioral|Task-orientated training|Task-Oriented Training (TOT) is a goal-directed exercise therapy, which help the people derive optimal control strategies for solving specific motor problems in real environment. In this study, TOT included stretching exercises, mobilizing exercise, strengthening exercises, seated reaching tasks, dexterity training and bimanual practice.
15969973|NCT03112473|Device|Transcutaneous electrical nerve stimulation (TENS)|The stimulator was 120z Dual-Channel TENS Unit (ITO PHYSITHERAPY&REHABILITION CO., LTD, Tokyo, Japan). The parameter (100 Hz, 0.2 ms square pulses, intensity barely below the motor threshold) of TENS followed our previous study
15969974|NCT03112473|Device|Sham electrical nerve stimulation|A identical-looking TENS devices that electrical circuit has been disconnected.
15969975|NCT03112460|Device|cardiopulmonary resuscitation with Zoll R Series defibrillator and defibrillator pads with a real-time CPR feedback option and CodeReview case analysis software|cardiopulmonary resuscitation with Zoll R Series defibrillator and defibrillator pads with a real-time CPR feedback option and CodeReview case analysis software
15969976|NCT03112447|Procedure|absorbable cartilage nail|The experiment group patients were fixed with absorbable cartilage nails
15969977|NCT03112447|Procedure|traditional Kirschner wires|The control group were fixed with traditional Kirschner wires
15969978|NCT03112434|Drug|Botulinum toxin type A|Botox injection in upper extremity for spasticity in pediatric CP patients
15969979|NCT03112408|Behavioral|Forward adaptation of reactive saccades|Protocol of reactive saccade where the target is displaced in the same direction as the saccade in order to induce an adaptive increase of saccade amplitude ('forward adaptation')
15969980|NCT03112408|Behavioral|Backward adaptation of reactive saccades|Protocol of reactive saccade where the target is displaced in a direction opposite to the saccade in order to induce an adaptive decrease of saccade amplitude ('backward adaptation')
15969981|NCT03112408|Behavioral|Execution of reactive saccades|Control protocol of reactive saccade with no displacement of the saccadic target (controlling for non specific factors possibly involved in forward and backward adaptation conditions)
15969982|NCT03112408|Behavioral|Generation of reactive saccades|Control protocol of reactive saccade with no displacement of the saccadic target (controlling for non specific factors possibly involved in adaptation condition)
15969983|NCT03112395|Device|Pio Medical Device|The Pio device combines the technologies of pulse modulated magnetic fields and light emission locally applied to the wound area.
15969984|NCT03112382|Drug|zinc supplement plus vitamin A and E|
15969985|NCT03112382|Drug|vitamin A and E|
15969986|NCT03112369|Behavioral|Narrative Exposure Therapy (NET)|An international evidence-based program (EBP) for PTSD based on exposure therapy, an oral tradition of story-telling, and use of tactile medium of natural elements.
15969987|NCT03112369|Behavioral|Motivational Interviewing w/Skills Training (MIST)|Motivational interviewing (MI) coupled with skills training is based on enhancing motivation to change and building skills to address substance use behaviors.
15969988|NCT03112356|Drug|99mTc-Leukoscan® scintigraphy|Gated single photon emission computed tomography with co-registered computer tomography (gated SPECT-CT) 6 hours and 24 hours after infusion of 99mTc-Leukoscan (1000 MBq)
15969989|NCT03112343|Device|Algorithm-based feedback messages|ICT-based intervention group have algorithm-based feedback messages in addition to conventional intervention
15969990|NCT03112343|Device|Personal Health Record|Subjects will save and send their health information to the server via the personal health record app
15969991|NCT03112330|Device|Plasma rich platelet injection|Plasma rich platelet injection with 26-gauge needle and 2cc syringe on inferior turbinate mucosa
15969992|NCT03112330|Device|Saline nasal spray|two puffs of isotonic saline nasal spray twice daily
15969993|NCT03112317|Other|Prevention of hypothermia|Patients are routinely warmed with forced air warming blankets, regular blankets, pre warmed intravenous fluid. Routines are ensured with use of the WHO Surgical Safety Checklist. The intervention is the use of operating theatre care measures to prevent mild hypothermia in surgical patients.
15969994|NCT03112304|Behavioral|MATCH-ADTC|MATCH - ADTC (Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems; Chorpita & Weisz, 2009) is a psychosocial intervention designed to treat children with multiple disorders and problems encompassing anxiety, depression, post-traumatic stress, and disruptive conduct, including the conduct problems associated with ADHD. It is recommended for children aged 6-15. MATCH is composed of 33 modules-i.e., specific treatment procedures derived from decades of research on EBTs. The various modules can be organized and sequenced flexibly to tailor treatment to each child's characteristics and needs.
15969995|NCT03112304|Other|TRAC|"TRAC (Treatment Response Assessment for Children) is a web-based system that provides weekly monitoring of the MATCH modules used and the child's response to treatment. Child's response to treatment is based on caregiver and child reports of (a) changes in problem severity on the standardized Brief Problem Checklist, and (b) changes in severity of the top treatment concerns identified by youths and caregivers. At the end of treatment, TRAC provides a complete record of modules used, and child treatment response, across all the weeks of treatment, as illustrated in the client dashboard."
15969996|NCT03112291|Procedure|Apexification|Apexification forms a calcified barrier in teeth with open apexes and pulp necrosis. It is used to treat immature teeth, but it does not promote the continuity of root formation.
15969997|NCT03112278|Procedure|Ceramic ultrathin occlusal veneers|Severely eroded teeth will be restored with ultrathin occlusal veneers made of ceramic (e.max CAD/Ivoclar Vivadent) by technology CAD-CAM bonded to the teeth (0.6 - 1.2 mm thick).
15969998|NCT03112278|Procedure|Composite resin ultrathin occlusal veneers|Severely eroded teeth will be restored ultrathin occlusal veneers made of composite resin (Lava Ultimate/3M Espe) by technology CAD-CAM bonded to the teeth (0.6 - 1.2 mm thick).
15970030|NCT03112044|Drug|Sofosbuvir-velpatasvir (400 mg/100 mg)|Patients will have standard monitoring with HCV RNA and liver panel assessment at 2 week intervals until HCV is undetectable and then at the end of treatment and 3 and 6 months following its completion. Post-operative transplant care and immunosuppression will be carried on as usual transplant practice at Toronto General Hospital.
15970728|NCT03106792|Dietary Supplement|Hairfinity #1|Main Hairfinity formulation
15969999|NCT03112265|Behavioral|Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems|MATCH-ADTC is designed for children aged 6-15. Unlike most evidence-based treatments (EBTs), which focus on single disorder categories (e.g., anxiety only), MATCH is designed for multiple disorders and problems encompassing anxiety, depression, post-traumatic stress, and disruptive conduct, including the conduct problems associated with ADHD. MATCH is composed of 33 modules-i.e., specific treatment procedures derived from decades of research on EBTs. The various modules can be organized and sequenced flexibly to tailor treatment to each child's characteristics and needs.
15970000|NCT03112265|Other|Monitoring and Feedback System|For each child, the web-based MFS system provides weekly monitoring of the MATCH modules used and the child's treatment response, in two forms (a) changes on the Behavior and Emotions Survey and (b) changes in severity of the top treatment concerns identified by youths and caregivers. At the end of treatment, the MFS provides a complete record of modules used, and child treatment response, across all the weeks of treatment.
15970001|NCT03112265|Behavioral|Treatment as usual|Treatment in the UC condition will use the procedures therapists and their supervisors consider appropriate and believe to be effective.
15970002|NCT03112252|Other|no specifications. Depending on the patients|patients with allergic rhinitis
15970003|NCT03112239|Device|Light-Emitting Diode Therapy (LEDT)|Light-emitting diode, has effects similar to the photobiomodulation by low-level laser intensity.
15970004|NCT03112226|Other|GnRHant + E2|GnRH antagonist with estradiol add-back
15970005|NCT03112226|Other|GnRHant + Placebo|GnRH antagonist with placebo add-back
15970006|NCT03112213|Drug|Tocilizumab|Tocilizumab (SC or IV) will be prescribed according to local clinical practice and the SPC.
15970007|NCT03112213|Drug|NSAIDs|Participants may receive NSAIDs, as prescribed by the treating physician or by self medication. Study protocol does not enforce any particular NSAID.
15970008|NCT03112200|Procedure|Subchondroplasty with Arthroscopy|The Subchondroplasty® (SCP®) Procedure targets and fills bone defects with AccuFill® Bone Substitute Material utilizing an arthroscopic / percutaneous approach. Using intraoperative fluoroscopy, the bone defect is localized relative to MRI findings The appropriate AccuPort® Delivery Cannula is drilled to the bone defect. AccuFill® Bone Substitute Material is then injected into the subchondral bone defect. The calcium phosphate (CaP) fills the edematous void and hardens within the Bone Marrow Lesion. The CaP is resorbed over time and replaced with new bone during the healing process.
15970009|NCT03112200|Procedure|Arthroscopy Alone|An endoscopic examination, therapy and surgery of the knee joint.
15970010|NCT03112187|Drug|Iron Supplement|Ferfer® is a multi-ingredient supplement containing micro-encapsulated iron pyrophosphate (to form liposomes), vitamin C and vitamin B12 which are valuable for the control of nutritional deficiencies or increased organic needs of iron.
15970011|NCT03112174|Drug|Ibrutinib|Administered orally once daily
15970012|NCT03112174|Drug|Venetoclax|Administered orally once daily
15970013|NCT03112174|Drug|Placebo Oral tablet to match Venetoclax|Administered orally once daily
15970014|NCT03112161|Other|Eucaloric Feeding Period|
15970015|NCT03112161|Other|Overfeeding Feeding Period|
15970016|NCT03112161|Other|Underfeeding Feeding Period|
15970017|NCT03112148|Drug|10 mg dose MR formulations,10 mg dose of tofacitinib IR solution|"For the the relative bioavailability (BA) assessment , the investigational product(s) are:
~Test: 10 mg dose of age-appropriate MR formulations (MR-fast, MR-moderate, MR-slow). Each formulation contains 0.025 mg of tofacitinib/mg of microsphere. Reference: 10 mg dose of tofacitinib IR solution (1 mg of tofacitinib/mL).
~For the the food effect assessment, the investigational product(s) are:
~Test: 10 mg dose of age-appropriate MR formulations (MR-fast or MR-slow) c-oadministered with high-fat FDA breakfast. Reference: 10 mg dose of age-appropriate MR formulations (MR-fast or MR-slow) administered under fasted state."
15970018|NCT03112135|Drug|Tranexamic Acid|TXA of 10-15 mg i.v over 30 min. followed by infusion in adose of 1 mg / kg /hr
15970019|NCT03112135|Drug|Tranexamic Acid|Topical TXA 1 gm diluted in 200 ml saline
15970020|NCT03112135|Drug|Adrenalin|Topical adrenaline 1 mg diluted on 200 ml saline
15970021|NCT03112122|Biological|autologous bone marrow concentrate|injection of autologous bone marrow concentrate
15970022|NCT03112122|Biological|bone substitute i-FactorTM|subchondral injections of i-FactorTM
15970023|NCT03112122|Procedure|core decompression|subchondral anterograde drilling
15970024|NCT03112109|Other|'New care'|Frail elderly receiving care within new organisational models delivering integrated healthcare (IHC) supported by ICT infrastructure (electronically shared-care platform) as provided by pilot sites individually.
15970025|NCT03112096|Drug|[18F]THK-5351|Imaging for evaluating the biodistribution, pharmacokinetics and safety of abnormal tau protein in the brain
15970026|NCT03112083|Dietary Supplement|Nutritional counseling A|Krill powder capsules
15970027|NCT03112083|Dietary Supplement|Nutritional counselling B|Placebo capsules
15970028|NCT03112070|Other|Water aerobic exercise session (WATER)|A continuous session of dynamic water aerobic exercise which consist of a dynamic warm-up period (5 minutes), an active exercise period (35 minutes), and a cooldown period (5 minutes) to total 45 minutes. Heart rate (HR) will be continuously measured with heart monitors (Polar) to confirm the intensity of the WATER session. The WATER intensity will be calculated according to the formula proposed by Kruel for exercise in an aquatic environment18 as follows: HR for exercise = % x (HRmax - ΔHR); % is the intensity of exercise; HRmax is the maximum HR (estimated by 220 - age); ΔHR represents the difference between resting HR on land and resting HR in the water environment. Exercise intensities: 55-60% HRmax during warm-up; 70-75% HRmax during active exercise; and 55-60% HRmax during cooldown.
15970029|NCT03112057|Diagnostic Test|harmonic generation (HGM) microscopic methods.|a frequency-dependent optical microscopy system with a near-infrared light source with a wavelength of 1230 nm was used to detect the diseased site and normal skin.Use erbium-Jacob (Er-YAG) laser exfoliation. the participants need to lie down, wear goggles. The lens sucker device to help fix the skin examination site. Based on the experience of the past 118 subjects, the participants did not discomfort. The total time of the laser irradiation on the same skin is no more than 30 minutes, the maximum laser power is no more than 0.15 watts, irradiation in the skin of the total energy of the laser does not exceed 270 joules. After the experiment, the investigators immediately check the skin for the participants
15970417|NCT03109249|Drug|SPARC1613|Single intravenous infusion of 260 mg/m2 of SPARC1613 delivered over 25 minutes in either of two periods (Period 1 or 2)
15970031|NCT03112044|Device|Ex Vivo Lung Perfusion (EVLP)|Normothermic EVLP is a method of donor lung preservation, assessment, treatment, and repair of injured organs. This method allows donor lungs to be treated for at least 12h under protective physiological conditions.
15970032|NCT03112031|Drug|Tamoxifen|Tamoxifen will be given orally in a dose of 300mg/day for the first 14 days following randomization. It will be administered by nasogastric tube where patients are unconscious. The Tamoxifen will be administered in the morning combined with amphotericin and fluconazole dose.
15970033|NCT03112031|Drug|Amphotericin B|Patients will receive amphotericin 1mg/kg/day i.v. once daily orally for the first 2 weeks.
15970034|NCT03112031|Drug|Fluconazole|Patients will receive fluconazole 800mg once daily orally for the first 2 weeks. Amphotericin and fluconazole will be administered simultaneously. After the first 2 weeks of study treatment, all patients will receive fluconazole 800mg/day for 8 further weeks, until the study end.
15970035|NCT03112018|Behavioral|data strengthening|Data strengthening: initial training, monthly data collection and feedback on data quality, access to dashboards, periodic Data Quality Assessments
15970036|NCT03112018|Behavioral|modified Safe childbirth checklist - control|modified Safe Childbirth Checklist (mSCC) implementation: provision of the mSCC to facilities, limited feedback and mentoring on its use
15970037|NCT03112018|Behavioral|modified Safe childbirth checklist - enhanced|modified Safe Childbirth Checklist (mSCC) implementation: provision of the mSCC to facilities, ongoing intensive feedback and mentoring on its use
15970038|NCT03112018|Behavioral|PRONTO training|Health provider training (PRONTO): initial 2-days modular training followed by a 6-week mentoring sessions (Kenya) or periodic modular refreshers and supplemental mentoring (Uganda), each over a 9-12 month period
15970039|NCT03112018|Behavioral|QI cycles|Quality Improvement Cycles (QI): facility teams performing PDSA cycles with mentoring support and twice annual Learning Collaborative sessions, plus opportunities to apply for small amounts of funds to support change efforts
15970040|NCT03112005|Procedure|Color fundus photography|Subjects will undergo fundus photography before and after administration of mydriatic agent.
15970041|NCT03112005|Drug|Mydriatic Agent|Subjects will be administered mydriatic medication to dilate their pupils.
15970042|NCT03111992|Drug|PDR001|Anti-PD1 antibody
15970043|NCT03111992|Drug|CJM112|Anti-IL-17A antibody
15970044|NCT03111992|Drug|LCL161|Oral small molecule SMAC-mimetic
15970045|NCT03111979|Dietary Supplement|beta-alanine|
15970046|NCT03111979|Dietary Supplement|Placebo|
15970047|NCT03111966|Other|Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir|Spanish cohort with HCV treated in real practice with Elbasvir/Grazoprevir
15970048|NCT03111953|Procedure|Roux-en-Y Gastric Bypass Surgery|"In Roux-en-Y Gastric Bypass Surgery a small gastric pouch is created and connected to a segment of jejunum. Bowel continuity is restored by reconnecting the Roux limb and the biliopancreatic limb approximately ~75-150 cm distal to the gastrojejunostomy. Therefore, ingested food bypasses most of the stomach, the entire duodenum, and a short segment of the jejunum."
15970049|NCT03111953|Procedure|Biliopancreatic Diversion Surgery|In Biliopancreatic Diversion Surgery a horizontal gastrectomy is conducted leaving a portion of the stomach, which is connected to the small intestine, ~250 cm from the ileocecal valve and the biliopancreatic limb is connected to the ileum, ~50 cm from the ileocecal valve. Digestive secretions from the biliopancreatic limb mix in the common channel, where ingested food is also delivered by the alimentary limb.
15970050|NCT03111940|Procedure|Optimisation of the result of intracoronary stenting according to specific algorithm|
15970051|NCT03111927|Other|Infant Formula: enriched level of myelin-relevant nutrients|"Feeding with the assigned infant formula can begin as soon as the child is enrolled in the study (from 2 weeks up to 5 weeks of life) and will last up 12 months of age (+/- 2 weeks).
~The volume of feed required by the child per day will depend upon age, weight, and appetite. The product should be given daily ad libitum to the child from enrollment up to 12 months."
15970052|NCT03111927|Other|Infant formula: standard level of myelin-relevant nutrients|"Feeding with the assigned infant formula can begin as soon as the child is enrolled in the study (from 2 weeks up to 5 weeks of life) and will last up 12 months of age (+/- 2 weeks).
~The volume of feed required by the child per day will depend upon age, weight, and appetite. The product should be given daily ad libitum to the child from enrollment up to 12 months."
15970053|NCT03111914|Diagnostic Test|Dual Energy Computed Tomography|"The subject's diagnostic scan will be preceded by a not clinically indicated non enhanced dual energy scan. The overall radiation dose to the patient for the first and second acquisition will be twice the radiation dose of a conventional CT of the chest, abdomen and pelvis. The non enhanced dual energy scan will be repeated during a clinical follow-up after the subject's first three months of enrollment and at a clinical follow-up after six months of enrollment.
~The clinically-indicated, contrast-enhanced diagnostic scan will be performed according to standard of care."
15970054|NCT03111901|Drug|Pembrolizumab|Pembrolizumab solution
15970055|NCT03111901|Drug|Interleukin-2|Interleukin-2 solution
15970056|NCT03111888|Device|Silicone Stent Airway Implant|The Patient-Specific Tracheobronchial Stent is a silicone stent indicated for use in adults that have stenosis of the airway. The subject device takes a CT scan, thresholds out the airway from the other anatomy, and allows the physician to digitally build the stent to his/her desired dimensions. According to the physician's design, a patient-specific stent can be manufactured using rapid prototyping technology. The patient-specific stent is indicated for use with any rigid bronchoscopy/stent application system that fits the design envelope.
15970057|NCT03111875|Device|aggressive warming|Patients will be pre-warming 30 minutes before induction of anesthesia and aggressively warmed during surgery to a target intraoperative core temperature between 37 and 37.5°C.
15970058|NCT03111875|Device|routine thermal management|A forced-air cover will be positioned but will not initially be activated. The warmer will be activated when core temperature decrease to 35.5°C.
15970059|NCT03111862|Diagnostic Test|NSTEMI Rule-Out according to hs-TnT|Rule-Out according to the rapid rule-out protocol of the current ESC Guidelines
15970060|NCT03111849|Other|sarcopenia|Prevalence of sarcopenia in hospitalized chronic obstructive patients
15970061|NCT03111836|Behavioral|Control Group|Received general information about blood pressure control. All subjects will be sent 16 e-messages on a weekly schedule.
15970418|NCT03109249|Drug|Reference1613|Single intravenous infusion of 260 mg/m2 of Reference1613 delivered over 30 minutes in either of two periods (Period 1 or 2)
15970063|NCT03111836|Behavioral|User-driven group|The user-driven e-Counselling group will receive a lifestyle program where the user are able to choose areas of focus. All subjects will be sent 16 e-messages on a weekly schedule.
15970064|NCT03111823|Behavioral|Exercise Intervention|Undergo aerobic exercise sessions
15970065|NCT03111823|Other|Quality-of-Life Assessment|Ancillary studies
15970066|NCT03111823|Other|Questionnaire Administration|Ancillary studies
15970067|NCT03111810|Drug|AZD4017 and prednisolone|The drug AZD4017 will be given together with prednisolone 20mg daily for 7 days to compare its effects on metabolic tissues against the placebo arm where the participants will take placebo and prednisolone 20mg daily for 7 days.
15970068|NCT03111810|Drug|Placebo Oral Tablet and prednisolone|Placebo Oral tablet will be given together with prednisolone 20mg daily for 7 days to compare the effects on metabolic tissues of AZD4017 and prednisolone 20mg daily against the placebo arm.
15970069|NCT03111797|Drug|Morphine|we observe the self-patient controlled morphine consumption during the first 48h after surgery
15970070|NCT03111797|Other|Cardiac output measure|we observe the cardiac output during surgical procedure using a non-invasive cardiac output monitoring device (ClearSight from Edwards lifescience laboratory )
15970071|NCT03111784|Other|Fish consumption and lipid profiles|
15970072|NCT03111771|Procedure|carcinological surgery|carcinological surgery for Group K +
15970073|NCT03111771|Procedure|cervical surgery|cervical surgery for Group K-
15970074|NCT03111758|Device|Flow augmentation|Augmenting venous flow following deep venous stenting in patients with Postthrombotic syndrome
15970075|NCT03111732|Biological|Pembrolizumab (MK-3475)|200 mg will be administered as an IV infusion on Day 1 of each 21 day cycle
15970076|NCT03111732|Drug|Oxaliplatin|130mg/m(2) IV Infusion will be administered as an IV infusion on Day 1 of cycles 1-6
15970077|NCT03111732|Drug|Capecitabine|750 mg/m(2) will be administered orally twice a day on Days 1-14 of cycles 1-6
15970078|NCT03111706|Procedure|Cesarean section|During Cesarean delivery the lower uterine segment (LUS) was defined as the part of the uterus below the uterovesical peritoneal reflection. After opening the visceral peritoneum and performing the bladder dissection, the LUS was assessed for integrity of the CS scar by the operating surgeon to avoid bias by the sonographic findings. Scar dehiscence was defined as the presence of either transparent LUS with visible contents, presence of well-circumscribed scar defect or presence of frank uterine rupture.
15970079|NCT03111693|Other|Unenhanced Coro-CT|All unenhanced coroCT examinations are performed on the same 64-Row CT scanner (discovery CT 750 HD scanner, GE Helthcare), using prospective ECG-triggerring.
15970080|NCT03111680|Other|environmental intervention|a multi component environmental intervention
15970081|NCT03111667|Behavioral|Teen Marijuana Check Up|Two session Motivational Enhancement Therapy intervention. The first MET session relies on the use of motivational interviewing skills to hear the student's history and current concerns with marijuana. The second session involves the provision of a personalized feedback report based on the student's baseline assessment that reviews normative feedback on marijuana use, consequences experienced, money spent on marijuana, other drug and alcohol use, social supports for quitting and life goals.
15970082|NCT03111667|Other|Treatment as Usual|Referral to community resources
15970083|NCT03111667|Behavioral|Gold Standard Coaching|Weekly coaching and feedback about adherence to Motivational Interviewing Skills and intervention delivery in a group setting.
15970084|NCT03111667|Behavioral|As Needed Coaching|As needed coaching and feedback about adherence to Motivational Interviewing Skills and intervention delivery in an individual setting.
15970085|NCT03111654|Diagnostic Test|Compare the risk of a vascular event|"Collected in a post-stroke follow-up consultation, patient clinical outcome data, functional and cognitive disability, standardized, using validated scales.
~Analysis of selected therapeutic options for the prevention of AF ischemic events."
15970086|NCT03111641|Diagnostic Test|Lung ultrasonography|Lung ultrasound scan during preoperative anaesthesia consultation
15970087|NCT03111628|Drug|Omalizumab|omalizumab 300 mg every 4 weeks by subcutaneous injection
15970088|NCT03111615|Drug|Aromatase Inhibitors|"Aromatase Inhibitor to start immediately after diagnosis of a Luminal Invasive Breast Carcinoma Patients will be given Letrozol 2.5 mg or Anastrazol1 mg, every 24H and all of them will be given Calcium + Vit D supplement.
~Venlafaxin 75 mg is to be administrated cases indicated"
15970089|NCT03111602|Other|restrict polyphenol-rich foods|dietary orientation to restrict polyphenol-rich foods
15970090|NCT03111589|Biological|Inactivated influenza A (H1N1) virus vaccine|All groups of patients and the control group will receive the new annually recommended inactivated influenza A (H1N1) virus vaccine.
15970091|NCT03111589|Diagnostic Test|Blood sampling|Testing of the different humoral immune responses to vaccines or to erythrocyte alloantigens.
15970092|NCT03111563|Other|Warm saline distension media in office hysteroscopy|warm saline distension media in office hysteroscopy
15970093|NCT03111550|Device|Investigational Intraocular Lens Device #1: TECNIS Model ZHR00|Intraocular lens replaces the natural lens removed during cataract surgery.
15970094|NCT03111550|Device|Investigational Intraocular Lens Device #2: TECNIS Model ZQR00|Intraocular lens replaces the natural lens removed during cataract surgery.
15970095|NCT03111550|Device|TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00|Intraocular lens replaces the natural lens removed during cataract surgery.
15970096|NCT03111537|Other|Cigarettes|Smoke their usual brand of cigarettes and follow their normal patterns of use.
15970097|NCT03111537|Other|E-Cigarette|Use of E-cigarette: multiple flavors offered.
15970098|NCT03111537|Other|Nicotine Gum or Lozenge|Subject choice: Use of nicotine gum or nicotine lozenge, multiple flavors offered
15970099|NCT03111524|Other|Classroom Communication Resource|The Classroom Communication Resource intervention is a classroom- and group-based interventions administered by teachers. It includes a social story, role-play and teacher-led discussion
15970100|NCT03111524|Other|No intervention|No intervention is administered in this group as these are control groups
15970101|NCT03111511|Drug|Drospirenone/Ethinylestradiol|A single dose of drospirenone/ethinylestradiol 3 mg/0.02 mg (OC) tablets on Days 1 and 21.
15970102|NCT03111511|Drug|Midazolam|Midazolam 2 mg orally on Days 1 and 21.
15970419|NCT03109236|Drug|GCSF|5 doses of GCSF injection will be injected under the skin on the abdomen to mobilize the bone marrow cells.
15970956|NCT03104959|Other|placebo|
15970103|NCT03111511|Drug|JNJ-56136379|JNJ-56136379 dose will be administered orally at a dose of 250 mg (as 2 tablets of 100 mg + 2 tablets of 25 mg) on Days 6 and 7 and at a dose of 170 mg (as 1 tablet of 100 mg+ 2 tablets of 25 mg + 4 tablets of 5 mg) on Days 8 to 25.
15970104|NCT03111498|Other|practice-based training programme (one-to-one teaching)|practice-based training programme (one-to-one teaching) for conducting VAD
15970105|NCT03111498|Other|theory-based training programme|theory-based training programme for conducting VAD
15970106|NCT03111485|Drug|Sinemet CR|Capsule 250 mg / 50 mg taken at bedtime
15970107|NCT03111485|Drug|Placebo oral capsule|Capsule taken at bedtime
15970108|NCT03111472|Other|Self-management guide for people with Parkinson's who fall and their informal caregivers|The self-management guide will be developed utilising information from people with Parkinson's, informal caregivers of people with Parkinson's, healthcare professionals and a systematic review of self-management interventions for people with Parkinson's who fall.
15970109|NCT03111459|Device|Medtronic Valiant Thoracoabdominal Stent Graft System|The Medtronic Valiant Thoracoabdominal Stent Graft System is made up of two main body components and makes use of several off-the-shelf FDA-approved stent graft components The system is comprised of two investigational devices that include the thoracic bifurcation and the visceral manifold. The thoracic bifurcation is deployed in the thoracic aorta and provides the proximal seal for the device. The two limbs of the thoracic bifurcation allows for continued aortic flow while deploying the visceral segment. The visceral manifold is deployed within the larger 20 mm limb of the thoracic bifurcation to set the stage for the visceral debranching. The branches of the visceral manifold extend to the visceral vessel with the use of covered bridging stents and provide distal seal of the manifold.
15970110|NCT03111446|Procedure|Spinal Anesthesia|Spinal needle 25G with Quincke's bevel will be used. It will be induced with a total of 10 mg of 0.5% hyperbaric bupivacaine and 20 mcg fentanyl (total volume 2.4 ml) at the L3-4 interspace. The parturient will be returned to the supine position with a left lateral tilt of 15° to facilitate left uterine displacement. The upper sensory block level will be checked 5 min after the spinal injection by assessing the loss of cold sensation from alcohol swabs, to ensure that a Th6 sensory block level has been achieved.
15970111|NCT03111446|Procedure|General Anesthesia|Pre-oxygenation with oxygen 100% via a tight fitting mask rapid sequence technique. Induction is by thiopental (5 mg kg lean body weight) and succinylcholine1.5 mg kg body weight), cricoid pressure should be applied before consciousness is lost and kept in place until confirmation of tracheal intubation with capnography and the cuff of the tracheal tube is inflated. Auscultating the chest helps exclude endobronchial intubation. At this point, surgery may commence.
15970112|NCT03111433|Dietary Supplement|Coenzyme Q10|Coenzyme Q10 soft gelatin capsule 100mg
15970113|NCT03111433|Drug|Insulin|multiple dose insulin injection therapy
15970114|NCT03111420|Drug|P2Y12 inhibitor|Administration of P2Y12 inhibitor antiplatelet therapy
15970115|NCT03111420|Device|Platelet function test|Blood is drawn for testing of platelet aggregation activity
15970116|NCT03111407|Procedure|total knee arthroplasty|surgical procedure in which damaged parts of the knee joint are replaced with an implant.
15970117|NCT03111381|Drug|Toradol|IV toradol
15970118|NCT03111368|Procedure|Endoscopic ultrasound-guided fine needle aspiration|pancreatic solid mass punctured with a 22G endoscopic ultrasound needle
15970119|NCT03111355|Dietary Supplement|Brazil nut|one nut a day for 2 months, no intervention for 2 months
15970120|NCT03111342|Drug|Anesthesia|A 2% lidocaine without vasoconstrictor injection into the cervix
15970121|NCT03111342|Procedure|Dry-needling|A placement of thin needle into the cervix without substance injection
15970122|NCT03111329|Other|No aspiration of gastric residuals|No assessment of gastric residuals will be performed prior to administering 3-hourly feeds with increasing amounts of the feeds given as per a predefined plan
15970123|NCT03111316|Drug|Cervidil 10 MG Vaginal Insert|Dinoprostone vaginal insert is a thin, flat, polymeric slab which is rectangular in shape with rounded corners contained within the pouch of an off-white knitted polyester retrieval system, an integral part of which is a long tape. Each slab is buff colored, semitransparent and contains 10 mg of dinoprostone in a hydrogel insert. An integral part of the knitted polyester retrieval system is a long tape designed to aid retrieval at the end of the dosing interval or earlier if clinically indicated. The finished product is a controlled release formulation which has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg/hr.
15970124|NCT03111316|Device|Foley Catheter|The balloon on the end of the Foley catheter will be inflated with 30 mL of sterile water, pulled back against the internal os of the cervix, and taped to the maternal thigh under minimal tension.
15970125|NCT03111303|Device|mechanical ventilation|Connection to mechanical ventilator
15970126|NCT03111290|Device|Direct Cortical Stimulation|A train of periodic electrical pulses is delivered between two local electrodes implanted in the brain
15970127|NCT03111290|Device|Direct Cortical Stimulation Sham|Sham trials where no electric pulse is delivered
15970128|NCT03111277|Device|Experimental: ExAblate Transcranial treatment|Patients' head will be placed in a device to hold it still for the treatment. Patients will lie headfirst on the ExAblate table. The ExAblate Transcranial helmet will be placed on their head. A device will be placed over their head to hold it and the helmet still. The investigators will measure the study participant's heart, blood pressure, temperature, and breathing rate before the treatment begins. MRI scans will be taken to make sure the ultrasound waves will be aimed exactly within the target. The space between the rubber diaphragm and the helmet will be filled with water. The water will be chilled to avoid heating of the scalp and skull during the ultrasound treatment. A series of MR images will be taken to identify the target area, and plan the study treatment. The study investigators will decide on the area of participant's brain that will be treated. The ExAblate Transcranial system will compute a plan to cover the treatment area.
15970129|NCT03111264|Behavioral|CHAMP|"The CHAMP only group intervention is based on Food Friends & Mighty Moves, a nutritional program designed to introduce new foods over the course of 12 weeks to preschoolers to create positive eating experiences. In conjunction with the nutritional program, the intervention also consists of an 18 week physical activity program designed to develop gross motor skills."
15970130|NCT03111264|Behavioral|CHAMP+|The CHAMP+ component is comprised of a curriculum of parenting, wellness, physical activity, and feeding in the home environment. The CHAMP+ intervention will span over the course of the CHAMP intervention.
15970484|NCT03108755|Drug|Placebo|oral
15970131|NCT03111251|Behavioral|Provider assessment and feedback|Tailored immunization reports highlighting adolescent vaccination rates at the individual, clinic and network levels are distributed by clinic champions every quarter. Reports track vaccination rates over time and allow physicians to compare their rates to the national goal.
15970132|NCT03111251|Behavioral|Provider reminders|An EHR-based reminder system informs providers when patients are due or overdue for HPV vaccination.
15970133|NCT03111251|Behavioral|Provider education|Provider education is being delivered through a comprehensive online continuing education activity that is tailored specifically to physicians, nurses, and clinical staff at TCP practices. It focuses on HPV vaccination best practices and communicating with parents about the HPV vaccine.
15970134|NCT03111251|Behavioral|Patient reminders|Patient reminders are delivered through MyChart, the clinics' online personal health record system, to inform patients (parents) that they are due or overdue for HPV vaccination.
15970135|NCT03111251|Behavioral|Parent education|The parent education intervention (currently in development) will employ innovative strategies to identify and overcome barriers to HPV vaccination.
15970136|NCT03111238|Drug|REX-001|REX-001 is administered through an intra-arterial catheter.
15970137|NCT03111238|Drug|Placebo|Placebo is administered through an intra-arterial catheter.
15970138|NCT03111225|Diagnostic Test|massage|a 15 minutes thoracic massage will be added to the regular physical therapy treatment
15970139|NCT03111212|Drug|Iloprost|Iloprost nebulized
15970140|NCT03111212|Drug|control|sodium chloride 0,9% nebulized
15970141|NCT03111199|Other|Cryotherpy|Cryotherapy will be used by means of ice packs over a painful region. The ice will be crushed inside a bag so that it is in an ideal size that provides a coupling in a painful column in the lumbar spine; Once it has been inserted in the plastic bag and before closing it all the air must be removed to avoid a faster thawing of the ice and have difficulties of coupling.
15970142|NCT03111199|Other|TENS Burst|The TENS Burst therapy will be performed using the KLD Sonophasys EUS 0503 electrotherapy device connected in the current therapy mode with the following parameters: 4Hz frequency, high pulse duration of 200 μsec and the current intensity will be at the maximum amplitude To generate visible muscle contraction without generating pain / discomfort. A channel will be used using self-adhesive electrodes arranged parallel to the erector muscle of the spine, so that the region to be treated is between the electrodes.
15970143|NCT03111199|Other|TENS Burst Placebo|The TENS Burst placebo therapy will be performed using the KLD Sonophasys EUS 0503 electrotherapy device connected in the current therapy mode with the following parameters: 4Hz frequency, high pulse duration of 200 μsec and the current intensity will be on but without Produce the effects of visible muscle contractions because the channel will not be properly coupled in the apparatus so that the stimulation does not reach the patient. A channel will be used using self-adhesive electrodes arranged parallel to the erector muscle of the spine, so that the region to be treated is between the electrodes.
15970144|NCT03111199|Other|Education|After the electrophysical intervention, a moment of education and awareness will be held, in which the participants will receive information about the purpose of the treatment; Anatomy and biomechanics of the lumbar spine; Chronic non-specific back pain; Cognitive, emotional, genetic, social, and lifestyle factors; Intrinsic and extrinsic physical factors, biopsychosocial model: beliefs of pain and hypervigilance; Concepts of joint protection; Energy conservation and general guidelines.
15970145|NCT03111186|Drug|Oxycodone Hcl 5Mg|oxycodone HCl 5 mg up to six times daily as needed for pain
15970146|NCT03111186|Drug|Ibuprofen 400 mg|Ibuprofen 400 mg up to six times daily as needed for pain
15970147|NCT03111186|Drug|Acetaminophen 650 mg|Acetaminophen 650 mg up to four times daily as needed for pain
15970148|NCT03111173|Device|Holter Device|MyECG E3.80 Holter Recorder
15970149|NCT03111160|Procedure|SMILE procedure using lower energy (100, 105, and 110 nJ)|Based on the review of literature, we regarded SMILE using energy levels of 115 nJ or higher as 'conventional' energy-SMILE (C-SMILE). Since 500kHz VisuMax femtosecond laser used in this study had a threshold photodisruption energy level of 100 nJ, lowest energy level of L-SMILE was set at 100 nJ. Because the spot distance must be changed by approximately 1 μm when laser energy changed by 50 nJ, we could set the maximum laser energy to 150 (100 + 50) nJ as highest one of C-SMILE while keeping the spot distance constant. Finally, we established two groups divided by different laser energies: L-SMILE group using lower energy levels of 100, 105, and 110 nJ, and C-SMILE group using 'conventional', not higher, energy levels of 115 to 150 nJ.
15970150|NCT03111160|Procedure|SMILE procedure using conventional energy (115 to 150 nJ)|The SMILE procedures were conducted in the Eyereum Eye Clinic (Seoul, South Korea). The target postoperative refraction was emmetropia. The surgery, using standardized techniques, was performed by an experienced surgeon (D.S.Y.K.) using the VisuMax system. The surgical parameters used during SMILE were as follows: repetition rate of 500 kHz, pulse energy 100 to 150 nJ (100, 105, and 110 nJ, L-SMILE; 115 to 150 nJ, C-SMILE), spot distance 4.5 μm (regardless of FSL energy), cap thickness 120 μm, and side-cut width 2 mm in the 12-o'clock position with an angle of 90°. After the anterior (upper) and posterior (lower) delineated plane of the intrastromal lenticule were well defined, the anterior and posterior interface were dissected with a micro-spatula with a blunt circular tip and extracted with micro-forceps. The integrity of the lenticule was also checked subsequently.
15970151|NCT03111147|Device|0 degrees humeral component version|RTSA with humeral component positioned in 0 degrees of version
15970152|NCT03111147|Device|30 degrees humeral component retroversion|RTSA with humeral component positioned in 30 degrees of retroversion
15970153|NCT03111134|Procedure|modified component separation technique|a new abdomen closure technique based on component separation technique
15970154|NCT03111121|Drug|Sugammadex|receive reversal with sugammadex 4mg/kg
15970155|NCT03111121|Drug|neostigmine|receive reversal with neostigmine 0.04 mg/kg
15970156|NCT03111121|Drug|glycopyrrolate|receive reversal with glycopyrrolate (0.01 mg/kg)
15970157|NCT03111108|Drug|EBR/GZR (50 mg/100 mg) FDC|One FDC tablet taken once daily by mouth for 8 or 12 weeks depending upon randomization.
15970158|NCT03111095|Other|Mobile Health|Subjects will submit blood pressure and weight measurements daily for 6 weeks postpartum. Subjects will have a video telehealth visit with the mobile health nurse at 48 hours and 7 days after discharge from the hospital.
15970485|NCT03108742|Device|INSORB|dermal stapler for skin closure
15970486|NCT03108742|Procedure|classic intradermal suture|intradermal suture for skin closure
15970159|NCT03111069|Procedure|Abdominal Surgery|"Resectable Intra-Abdominal/Pelvic Tumors Group: Participants receive peritonectomy, omentectomy, cytoreduction, (complete surgical tumor resection, no gross residual disease).
~Unresectable Intra-Abdominal/Pelvic Tumors Group: Participants receive debulking surgery (90% resection) , with no more than 5mm thick residual implants, totaling no more than 2.5cm2 of residual tumor."
15970160|NCT03111069|Drug|Doxorubicin|"Dose Escalation: Heated Doxorubicin delivered by Hyperthermic Intraperitoneal Chemotherapy (HIPEC). After abdominal surgery two large bore catheters are placed in the peritoneal cavity through the incision. Starting dose of Doxorubicin is 15 mg/L of HIPEC perfusate.
~Dose Expansion Starting Dose: MTD from Dose Escalation."
15970161|NCT03111069|Radiation|Intra-Operative Radiation|Standard dose brachytherapy delivered to the residual pelvic tumor sites.
15970162|NCT03111056|Behavioral|Alc-ERDT|Web-based cognitive behavioral skills-based alcohol intervention that incorporates emotion regulation and distress tolerance skills
15970163|NCT03111043|Diagnostic Test|Head to pelvis CT scan|Introduction of early head to pelvis CT scan within 6 hours of out of hospital arrest as an adjunct to standard of care (no randomization)
15970164|NCT03111030|Behavioral|ProacTive SCI|"Participants will receive weekly physical activity coaching sessions. Each session will be 10-15 minutes, delivered either face to face, over Skype, or over the phone. Additional resources may be emailed to participants based on need throughout the intervention (for example, a goal, list of places to exercise, contact information to reach mentoring services). A typical session may include:
~An assessment of motivated the participant is to be physically active
~A: If motivated, a physical activity goal will be set, strategies will be reviewed, and resources to accomplish that goal will be provided.
~B: If not motivated, questions will be asked to understand why the reasons for lack of motivation. If it is for any reasons including barriers, fear, confidence, or knowledge, the interventionist will discuss strategies to overcome these obstacles.
~Progress and barriers will be reassessed and discussed."
15970165|NCT03111017|Other|Exercise Training|HFpEF patients randomized to either 16 weeks of exercise training or attention control group.
15970166|NCT03111004|Other|New Care|All settings that are in any way relevant to the provision of health and social care are integrated, including: out-of-hospital (community) services as well as hospitals, GPs' offices, community nurses, and any type of care practitioners, users' homes and volunteer service providers' offices
15970167|NCT03110991|Behavioral|Multicomponent Cognitive Behavioral Intervention administered via a smartphone App (CCIA)|Multicomponent Cognitive Behavioral Intervention administered via a smartphone App (CCIA)
15970168|NCT03110991|Behavioral|Multicomponent Cognitive Behavioral Intervention administered via a smartphone App+ telephone contact via conference call (CCIA+CC)|Multicomponent Cognitive Behavioral Intervention administered via a smartphone App+ telephone contact via conference call (CCIA+CC)
15970169|NCT03110978|Biological|Nivolumab|Given IV
15970170|NCT03110978|Radiation|Stereotactic Body Radiation Therapy|Undergo stereotactic body radiation therapy
15970171|NCT03110965|Behavioral|Yoga poses|Patients are asked to perform one or two yoga poses daily for 4-10 months
15970172|NCT03110952|Biological|TDENV-PIV|Single-dose vial with pre-filled syringe, subcutaneous injection
15970173|NCT03110952|Biological|TDENV-F17|Single-dose vial with pre-filled syringe 0.5 mL administered intramuscularly
15970174|NCT03110952|Other|Placebo|0.5 mL vial
15970175|NCT03110939|Other|hyperthermic perfusion|hyperthermic perfusion 1800-2000ml, normal saline, 45-48℃, 1 hour, speed 300-600ml/min (after surgery of advanced lung cancer/esophageal cancer)
15970176|NCT03110926|Drug|mFOLFOX6|Induction Chemotherapy
15970177|NCT03110926|Combination Product|Chemoradiation|Chemoradiation
15970178|NCT03110913|Other|dietary intakes|Four levels of methionine intakes will be provided by the reference protein drinks, 3 levels of methionine from lentils and 3 levels from lentils with rice.
15970179|NCT03110900|Drug|Haloperidol + lorazepam|Haloperidol + lorazepam + placebo
15970180|NCT03110900|Drug|Loxapine|loxapine + placebo
15970181|NCT03110874|Drug|one-way education|'Fluterol Inhalation Capsule(fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) : one-way education'
15970182|NCT03110874|Drug|two-way education|'Fluterol Inhalation Capsule(fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) : two-way education'
15970183|NCT03110861|Device|Pulsta® Transcatheter Pulmonary Valve (TPV) Replacement|Pulsta® Transcatheter Pulmonary Valve Replacement
15970184|NCT03110848|Drug|Atorvastatin|Atorvastatin 20 mg daily
15970185|NCT03110848|Drug|Methylprednisolone|500 mg of methylprednisolone weekly for 6 weeks, followed by 250 mg weekly for another 6 weeks, for a total dose of 4.5 mg.
15970186|NCT03110835|Radiation|Radioiodine|Administration of radioiodine
15970187|NCT03110822|Drug|Ruxolitinib Oral Tablet [Jakafi]|Ruxolitinib will be administered on days 1-28 of the treatment cycle.
15970188|NCT03110822|Drug|Lenalidomide|Lenalidomide will be administered on Days 1-21 of the treatment cycle.
15970189|NCT03110822|Drug|Methylprednisolone|Methyl-prednisolone will be administered on Days 1-28 of the treatment cycle.
15970190|NCT03110809|Dietary Supplement|Capsinoid|Capsinoids are nunpungent analogs of capsaicin that activate BAT by stimulating sensory neurons in the gastrointestinal tract. Chronic ingestion of capsinoids may stimulate the development or recruitment of new BAT from precursor stem cells within white adipose tissue depots.
15970191|NCT03110809|Dietary Supplement|Placebo|Placebo for capsinoid. Capsule contains no active ingredients.
15970192|NCT03110796|Device|Dressing with LU3103209 - Dose 1|Dressing with LU3103209 - Dose 1
15970193|NCT03110796|Device|Dressing with LU3103209 - Dose 2|Dressing with LU3103209 - Dose 2
15970194|NCT03110796|Device|Dressing without LU3103209|Dressing without LU3103209
15970195|NCT03110783|Biological|Bioseal|Upon completion of the sutured dural repair, the closure will be evaluated for intra-operative CSF leakage with a baseline Valsalva maneuver to 10-20 cm H2O for 5-10 seconds. Subjects who have a CSF leak will be enrolled into the study. If randomized to receive Bioseal, a thin layer will be applied to the entire length of the suture line and the adjacent area to approximately 5mm away, including all suture holes. Up to two layers of Bioseal may be used for each application. While Bioseal achieves complete coagulation, CSF leakage will be re-evaluated with the Valsalva maneuver to 10-20 cm H2O for 5 to 10 seconds.
15970489|NCT03108716|Procedure|microscrew internal fixation|The patients were assigned to treat with microscrew internal fixation after open reduction.
15970196|NCT03110770|Biological|VRC-ZKADNA090-00-VP|VRC-ZKADNA090-00-VP is composed of a single closed-circular DNA plasmid (VRC 5283) that encodes with wild type (wt) precursor transmembrane M (prM) and envelope (E) proteins from the H/PF/2013 strain of ZIKV
15970197|NCT03110770|Other|VRC-PBSPLA043-00-VP|A sterile phosphate-buffered saline (PBS) prepared for human administration as a placebo
15970198|NCT03110757|Biological|GLA-AF|Previously referred to as Gluco-pyranosylphospho-lipid A aqueous formulation (GLA-AF). It is a toll-like receptor-4 agonist
15970199|NCT03110757|Biological|Hepatitis B Virus Vaccine (Recombinant)|A non-infectious subunit viral vaccine derived from hepatitis B surface antigen (HBsAg) produced in yeast cells.
15970200|NCT03110757|Biological|Sm-TSP-2/Alhydrogel|Sm-TSP-2/Alhydrogel
15970201|NCT03110744|Drug|Palbociclib|application on 21 consecutive days of a 28 days cycle
15970202|NCT03110731|Behavioral|Physical training|Physical training (2x / week) was performed for 12 weeks
15970203|NCT03110718|Device|ArmeoP+real MV|All the subjects assigned to the experimental received a focal belly-muscle vibration on the spastic antagonist muscles (i.e. triceps brachialis-TB, deltoid-DE, and supraspinatus-SS) during shoulder abduction and elbow extension. MV was delivered by a pneumatic vibrator powered by compressed air (Vibraplus; @Circle, San Pietro in Casale, Italy) (fig. 2) wired to appropriate-muscle probe diameter (up to 2cm2). MV was set at a frequency of 80Hz and an individually adjusted vibration amplitude (approximately 2mm in indentation depth, mean pressure of 250mBar, which effectively induce inhibition of the monosynaptic reflex) so that it was just below the threshold for perceiving an illusory movement. We chose such set up to avoid any signs of muscle contraction potentially reflecting either possible voluntary movement or occurrence of the tonic vibration reflex (TVR).
15970204|NCT03110705|Behavioral|sport|recreaational sport : diving or multisport
15970205|NCT03110692|Behavioral|Default initiation|A default prescription template will be introduced in the palliative setting in order to reduce unnecessary daily image guided radiation.
15970206|NCT03110679|Biological|injection of autologous bone marrow concentrate|
15970207|NCT03110679|Biological|injection of hyaluronic acid.|
15970208|NCT03110666|Biological|Injection of autologous concentrated bone marrow aspirate|Percutaneous injections at the bone-cartilage interface (distal femur and proximal tibia)
15970209|NCT03110653|Drug|Remifentanil|Remifentanil will be continued postoperatively, while being decreased (gradually by 30% every 15 mins)
15970210|NCT03110653|Drug|NaCl 0.9%|NaCl 0.9% will be administered postoperatively, while being decreased by 30% every 15 mins.
15970211|NCT03110640|Biological|anti-CD19 CAR-T|Ex vivo-expanded autologous T cells modified to express CD19 CAR
15970212|NCT03110640|Drug|Fludarabine|Patients were given cyclophosphamide 500mg/m2/day on day -4 and fludarabine at 25 mg/m2/day on day -4, day -3, and day -2.
15970213|NCT03110640|Drug|Cyclophosphamide|Patients were given cyclophosphamide 500mg/m2/day on day -4.
15970214|NCT03110627|Device|VDD ICD (experimental group)|"Patients who are identified on clinical grounds for a single-chamber ICD will randomized to a VDD ICD (experimental group) or single chamber ICD (control group).
~The study will compare the Dx-ICD system (experimental) to standard VVI-ICD (control) on the ability to diagnose silent AF in patients without prior AF receiving an ICD for standard indications."
15970215|NCT03110627|Device|Single chamber VVI ICD (control group)|"Patients who are identified on clinical grounds for a single-chamber ICD will randomized to a VDD ICD (experimental group) or single chamber ICD (control group).
~The study will compare the Dx-ICD system (experimental) to standard VVI-ICD (control) on the ability to diagnose silent AF in patients without prior AF receiving an ICD for standard indications."
15970216|NCT03110601|Device|Control - Conventional SCS|Conventional SCS Parameters
15970217|NCT03110601|Device|Test - Stimgenics SCS|Stimgenics SCS Parameters
15970218|NCT03110588|Drug|PACE with Cabazitaxel (15 mg/m2)|Prednisone, Abiraterone, and Enzalutamide are administered orally; Cabazitaxel is be administered intravenously @ 15 mg/m2.
15970219|NCT03110588|Drug|PACE with Cabazitaxel (20 mg/m2)|Prednisone, Abiraterone, and Enzalutamide are administered orally; Cabazitaxel is be administered intravenously @ 20 mg/m2.
15970220|NCT03110575|Drug|TNX-102 SL|2 x TNX-102 SL, 2.8mg tablets taken daily at bedtime for 12 weeks
15970221|NCT03110562|Drug|Selinexor|oral 100 mg dose
15970222|NCT03110562|Drug|Bortezomib|subcutaneous dose of 1.3 mg/m2
15970223|NCT03110562|Drug|Dexamethasone|oral dose of 20mg
15970224|NCT03110549|Drug|TMB-607|
15970225|NCT03110549|Drug|Placebo|
15970226|NCT03110536|Diagnostic Test|Copenhagen Burnout Inventory|"A questionnaire based on Copenhagen Burnout Inventory will be completed by each participant to the study, at the beginning of the triage shift and after 2, 4 or 6 hours.
~The questionnaire also contains clinical cases that require triage coding."
15970227|NCT03110536|Other|Triage scoring efficacy|The triage scores of the first 5 and the last 5 cases assessed by the investigated nurse will be compared with the triage codes of an expert evaluator (nurse involved in designing The National triage Protocol).
15970228|NCT03110523|Drug|X0002|All subjects who provide informed consent will initiate the Screening Period of at least 14 (±3) days for the assessment of eligibility including radiographic evaluation of the lumbar spine. X-ray images must be collected within 4-11 hours after the subject wakes up. Those subjects who meet preliminary eligibility criteria will be treated with placebo in a subject-blind manner for 14(±3) days from Screening Visit to Day 1. Subjects with a placebo response exceeding 25% improvement in the average NPRS score over the previous 7 days will be excluded. Subjects with a Lane grading of 1 or 2 on their neutral lateral lumbar spine film per the central radiologist are eligible to be enrolled. At Day 1, eligible subjects will be randomly assigned to 1 of 2 treatment groups in a 1:1 ratio with a 1:1 ratio of active:placebo within each treatment group, and stratified evenly according to Lane Radiographic Grading Scale summary score (1 or 2) and gender.
15970229|NCT03110510|Drug|Fluorouracil|5FU 400mg/m2 bolus and then 2400mg/m2, continuous infusion D1-2
15970230|NCT03110510|Drug|Irinotecan Hydrochloride|Irinotecan 180 mg/m2
15970231|NCT03110510|Drug|leucovorin calcium|Leucovorin 200 mg/m2
15970232|NCT03110497|Radiation|Single application multi-fraction brachytherapy|Single application brachytherapy procedure to deliver high dose rate fractions of 9Gy, 7Gy and 7Gy with 6-12 hours apart under strict image guidance
15970233|NCT03110484|Drug|Pemetrexed 500 MG|Pemetrexed 500 mg/m2
15970234|NCT03110484|Drug|Erlotinib|Erlotinib 100mg once daily
15970235|NCT03110471|Behavioral|West Wales Adverse Drug Reaction (WWADR) Profile|Nurse-led medicines' monitoring in care homes: a process evaluation of the impact and sustainability of the West Wales Adverse Drug Reaction (WWADR) Profile and pharmacist involvement
15970236|NCT03110471|Behavioral|usual care|usual care
15970237|NCT03110458|Drug|SENS-111 100mg|SENS-111 100mg is presented as 1 Oral Dispersible Tablet of SENS-111 100mg + 1 Oral Dispersible Tablet of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 500 mg for the entire study.
15970238|NCT03110458|Drug|SENS-111 200mg|SENS-111 200mg is presented as 2 Oral Dispersible Tablet of SENS-111 100mg given twice on Day 1,second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 1000 mg for the entire study.
15970239|NCT03110458|Drug|Placebo Oral Tablet|Placebo is presented as 2 Oral Dispersible Tablets of placebo given twice on Day 1, second intake given approximately 12 hours (9 to 15 hours) after the first intake and thereafter given once daily on Days 2 to 5 inclusive. The corresponding total dose will be 0 mg for the entire study.
15970240|NCT03110445|Biological|rVV-740CTA|non replicating recombinant vaccinia virus expressing 7 Cancer Testis Antigen (CTA) epitopes together with CD80 and CD154(40L)
15970241|NCT03110432|Drug|PCSK9 Inhibitor [EPC]|drug use according to the respective product labelling
15970242|NCT03110432|Drug|Standard lipid lowering therapy|drug use according to the respective product labelling
15970243|NCT03110419|Other|Physical Exercise|The intervention program will follow the recommendations of the American College of Sports Medicine (ACSM, 2009), including aerobic, muscle strength, flexibility and balance exercise. The duration of the intervention will be 16 weeks with sessions 60 min performed in three alternate days.
15970244|NCT03110406|Other|whole-body vibration training|Training on the Vibrating platform will be performed with the patients in the static position.The exercises will be performed in the first two weeks for 10 minutes consisting of 60 seconds of low intensity and 30 seconds of standing rest in the anatomical position. From the second week to the end of the twelfth week (24 sessions) will be performed 15 minutes corresponding being 60 seconds of high intensity interspersed with 30 seconds of rest standing in the anatomical position. In the second month, the patient should be well adapted to the stimuli of the platform keeping the frequency of 35Hz and the amplitude 4mm. Monitoring of blood pressure, heart rate and peripheral oxygen saturation should be done every 5 minutes.
15970245|NCT03110393|Device|Ambu AuraGain|Insert and intubation of an Ambu® AuraGain™ laryngeal mask
15970246|NCT03110393|Device|Intersurgical i-gel|Insert and intubation of an Intersurgical i-gel®
15970247|NCT03110380|Drug|B/F/TAF|50/200/25 mg FDC tablet(s) administered orally once daily
15970248|NCT03110380|Drug|F/TAF|200/25 mg FDC tablet(s) administered orally once daily
15970249|NCT03110380|Drug|DTG|50 mg tablet(s) administered orally once daily
15970250|NCT03110380|Drug|DTG Placebo|Tablet(s) administered orally once daily
15970251|NCT03110380|Drug|F/TAF Placebo|Tablet(s) administered orally once daily
15970252|NCT03110380|Drug|B/F/TAF Placebo|Tablet(s) administered orally once daily
15970253|NCT03110367|Behavioral|Pain Reframing Intervention|Parents and youth in the intervention group will receive instructions about adaptive ways of reminiscing about the in-hospital and post-surgery periods. The intervention will draw from existing narrative-based interventions that have taught parents to reminisce with their children about past negative events in more elaborative and emotion-rich ways (e.g., using more open-ended questions, to follow in on children's answers by providing new details about the event, to talk more about emotions, and to praise children's answers).
15970254|NCT03110367|Behavioral|Attention Control Group|Parents and youth in the attention control group will watch a neutral 20-minute video that is not related to surgery (Planet Earth). Importantly, they will not talk about pain or the past surgery experience.
15970255|NCT03110354|Drug|DS-3201b|DS-3201b is supplied as 25 and 100 mg capsules packaged in high-density polyethylene (HDPE) bottles.
15970256|NCT03110341|Drug|Erythropoietin|rhEPO 750U/kg was injected within 72h after birth, subsequent injection was given every other day for 2 weeks (a cumulative dose of 5,250U/kg over the course of 7 separate intravenous injections.
15970257|NCT03110341|Drug|Normal saline|placebo (Normal saline 3 ml/kg birth weight) was injected within 72h after birth, subsequent injection was given every other day for 2 weeks.
15970258|NCT03110328|Drug|MK3475|anti-PD1 immunotherapy
15970259|NCT03110315|Drug|Suvorexant|See detailed information in associated Arm Description.
15970260|NCT03110315|Drug|Placebo|Sugar pill manufactured to mimic suvorexant 10 mg tablet.
15970261|NCT03110302|Behavioral|Prolonged exposure|PE is a manualized treatment developed by Dr. Edna Foa and her colleagues. In all three treatment modalities, 7-15 weekly, 90 minute individual sessions of PE will be provided. PE is based on emotional processing theory, which proposes that avoidance and negative thoughts about the self and the world maintain PTSD symptoms over time. According to emotional processing theory, effective treatment requires repeated activation of the trauma memory (as through memory and in vivo exposure) and incorporation of corrective information into the trauma fear structure. PE has several primary components: (1) psychoeducation about PTSD and avoidance; (2) imaginal exposure with processing, wherein the participant describes the traumatic memory aloud many times and discusses it with the therapist afterward; and (3) in-vivo exposure, wherein the participant engages in feared, but safe, activities that have been avoided since the traumatic event (e.g., crowded places, driving).
15970262|NCT03110289|Other|superdonor FMT|"Fecal microbiota transplantation (FMT) is the transfer of feces from a healthy superdonor to the patient."
15970263|NCT03110289|Other|autologous FMT|Fecal microbiota transplantation (FMT) with feces from the patient him/herself
15970264|NCT03110276|Drug|EYP001a|10 mg and 100 mg capsules. Number of capsules to be ingested will depend on the dose cohort. Administered orally once daily. Single dose (SAD) or 14 days treatment (MAD).
15970265|NCT03110276|Drug|Placebo|Placebo capsules, identical in appearance to the EYP001a 10 mg and 100 mg capsules.
15970266|NCT03110263|Other|Multicomponent internet-based self-help|Internet-based self-help on the basis of (Perlis, M. L., Jungquist, C., Smith, M. T., & Posner, D., 2006). The self-help program consists of eight text-based sessions and tasks. All participants in the active conditions receive guidance during 8-weeks treatment.
15970267|NCT03110263|Other|Internet-based sleep restriction|Internet-based self-help on the basis of (Perlis, M. L., Jungquist, C., Smith, M. T., & Posner, D., 2006). The self-help program consists of five text-based sessions and tasks. All participants in the active conditions receive guidance during 8-weeks treatment.
15970268|NCT03110237|Other|Control Balance Training (BT) class|Circuit training class with 11 stations, including: step-ups, ball kicking, balance beam, sit to stand, walk and carry, tandem walking, walking over a mat, walking up a ramp, walking at different speeds, speed walk, dual task walking.
15970269|NCT03110237|Other|Fallproof Balance Training (BT) class|There are four categories of exercises in this approach including: center of gravity control training (e.g. multi-directional weight shifts in standing, standing with altered base of support), multisensory training (e.g. standing on compliant surfaces, eyes open/closed), postural strategy training (e.g. resisted perturbation to facilitate ankle, hip or step strategy), and gait pattern variation training (e.g. walking with altered base of support , walking over and around obstacles). Each training category will be allocated 5 minutes with two exercises in each category. An additional 5 minutes will be allotted for games to challenge balance (balloon volleyball, pass the potato, circle soccer).There will be opportunity for group discussion and observational learning.
15970270|NCT03110224|Device|Subchondroplasty Procedure with AccuFill|Injection of the commercially available flowable calcium phosphate (CaP) synthetic bone-void filler, AccuFill®, into subchondral bone defects in the knee(Subchondroplasty (SCP) Procedure).
15970271|NCT03110211|Procedure|Physical Therapist Evaluation|Participants assigned to this group will receive an initial evaluation and treatment recommendations by a physical therapist.
15970272|NCT03110211|Procedure|Primary Care Physician|Participants assigned to this group will receive an initial evaluation and treatment recommendations by a primary care physician.
15970273|NCT03110198|Drug|Mesalazine|Mesalazine enema rectal administration at bedtime 4g/100 ml, once daily
15970274|NCT03110198|Drug|hydrocortisone sodium succinate|hydrocortisone sodium succinate rectal administration at bedtime 100mg/100 ml, once daily
15970275|NCT03110198|Drug|Mesalazine with hydrocortisone sodium succinate|Mesalazine with hydrocortisone sodium succinate rectal administration at bedtime 4g，100mg/100 ml, once daily for induction of remission
15970276|NCT03110185|Device|EEG|Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients.
15970277|NCT03110185|Device|fcDOT|Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients.
15970278|NCT03110185|Device|fcMRI|Brain activity will be recorded to evaluate differences in brain activity between patients with a delirium diagnosis and non-delirious control patients.
15970279|NCT03110172|Drug|Duloxetine Hydrochloride|The treatment group will receive duloxetine 60mg/24h to 8 weeks after operation
15970280|NCT03110159|Drug|Levulan® Kerastick®|Levulan® Kerastick® for Topical Solution will be applied to a designated area for 3 hours without occlusion prior to illumination with blue light
15970281|NCT03110159|Drug|BLU-U Blue Light Photodynamic Therapy|3 hours after Levulan® Kerastick® for Topical Solution is applied blue light illumination of designated area will be performed using the standard FDA approved treatment time of 16 minutes 40 seconds.
15970282|NCT03110146|Device|EnSite Precision|Ablation procedure
15970283|NCT03110133|Drug|Full Spectrum Microbiota|Orally administered donor derived microbiota
15970284|NCT03110133|Drug|Placebo|Placebo for CP101
15970285|NCT03110120|Drug|0.5% levobupivacaine injectable solution with 10 ml of physiological saline|Serratus plane block realized with a mixture of 10 ml of 0.5% levobupivacaine injectable solution with 10 ml of physiological saline
15970286|NCT03110120|Drug|0.5% levobupivacaine injectable solution with 10 ml of physiological saline|local infiltration of the wound with a mixture of 10 ml of 0.5% levobupivacaine injectable solution with 10 ml of physiological saline
15970287|NCT03110120|Drug|0.5% levobupivacaine injectable solution with physiological saline|Serratus plane block realized with 20 ml of injectable solution of physiological saline
15970288|NCT03110120|Drug|0.5% levobupivacaine injectable solution with physiological saline|local infiltration of the wound with 20 ml of injectable solution of physiological saline
15970289|NCT03110107|Biological|Ipilimumab|Specified dose on specified days
15970290|NCT03110107|Biological|BMS-986218|Specified dose on specified days
15970291|NCT03110107|Biological|Nivolumab|Specified dose on specified days
15970292|NCT03110094|Other|Adalimumab|It will be an interventional study with minimal risks and constraints, prospective, mono-centric, in current care. Patient management will not be changed during the study. It will be taken at two different tracking points (M0 and M3) 4 additional tubes and use of surplus articular fluid (M0 and M3).
15970293|NCT03110094|Other|Healthy volunteers|Collection of 2 tubes of blood. The values of the quantitative study of lymphocyte subpopulations will be compared to those obtained from healthy blood donors to define the standards used in this study.
15970294|NCT03110081|Procedure|Quadratus lumborum block|Quadratus lumborum (QL) block for open partial nephrectomy.
15970295|NCT03110081|Procedure|Epidural analgesia|Epidural analgesia for open partial nephrectomy.
15970296|NCT03110068|Diagnostic Test|contrast-enhanced ultrasound|The Aplio SSA-770A or Aplio 500 (Toshiba Medical Systems, Tokyo, Japan) equipped with a 375BT convex transducer (frequency range, 1.9 to 6.0 MHz). CHI is used with a mechanical index that ranged from 0.06 to 0.10. After activating CHI mode, a bolus injection of 2.4 ml of SonoVue (Bracco, Milan, Italy) is administered intravenously via an antecubital vein, followed immediately by a flush of 5 ml of normal saline solution. The targeted lesion should be observed continuously for 5 minutes, and the entire arterial and portal venous phases and several repetitions of the late phase are stored on the hard disk. The arterial, portal venous and late phases are defined as 0-30 s, 31-120 s and 121-360 s after the injection, respectively.
15970348|NCT03109704|Procedure|Sham manipulation|"The sham manipulation will be performed with the patient and the examiner positioned in the same manner as for the seated manipulation, however the examiner will apply only minimal pressure to maintain physical contact and skin lock with the patient. The examiner will then move the patient through the same range of motion but deliver no manipulative thrust."
15970349|NCT03109691|Drug|bupivacaine|group 1
15970350|NCT03109691|Drug|Dexamethasone|group 2
15970351|NCT03109691|Device|ultrasound|in all groups
15970297|NCT03110068|Diagnostic Test|contrast-enhanced computed tomography|The Aquilion 64-slice helical CT machine (Tokyo, Japan) is used. The imaging protocol for CT examinations is as follows: 0.5 mm × 64 mm collimation, 120 kV, 150-200 mAs for 64-slice helical CT examination. The standard triphasic scan procedure is used. An unenhanced helical sequence scan through the liver will be performed first; thereafter nonionic iodinated contrast material (Ultravist, Schering, Berlin, Germany) (1.5 mL/kg) will be administered via antecubital vein with power injection at a rate of 4 mL/s for 64-slice helical CT. The arterial phase sequence is obtained 25-32 s after contrast material administration, followed by a portal venous phase sequence 70 s after contrast agent administration.
15970298|NCT03110055|Drug|Grazoprevir/Elbasvir|anti-viral treatment for HCV
15970299|NCT03110055|Other|Medical records|Medical records of patients who underwent Transarterial Chemoembolization only, in the past.
15970300|NCT03110055|Procedure|Transarterial Chemoembolization|A minimally invasive procedure performed in interventional radiology to restrict a tumor's blood supply. Small embolic particles coated with chemotherapeutic drugs are injected selectively through a catheter into an artery directly supplying the tumor. These particles both block the blood supply and induce cytotoxicity, attacking the tumor in several ways.
15970301|NCT03110029|Drug|Efinaconazole 10% Topical Application Solution [JUBLIA]|Topical efinaconazole 10% solution (Jublia)
15970302|NCT03110029|Other|Application of Nail Polish|Application of Nail Polish
15970303|NCT03110016|Device|Smartphone Application|The participants use SPSRS to watch the motion picture for at least 10 min a day for 5 weeks.
15970304|NCT03110003|Drug|10 mg Bupivacaine|10 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl injected to the epidural space
15970305|NCT03110003|Drug|5 mg Bupivacaine|5 mg of preservative-free isobaric bupivacaine with 12.5mcg of fentanyl in combination with 10 mL of sterile saline injected into the epidural space.
15970306|NCT03109990|Drug|Dexmedetomidine|Patients in the experimental group will receive Dexmedetomidine during surgery.
15970307|NCT03109990|Drug|Saline|Patients in the control group will receive saline but not Dexmedetomidine during surgery.
15970308|NCT03109977|Drug|Zr-DFO-pertuzumab PET/CT|Zr-DFO-pertuzumab studies will be performed as hybrid PET/CT examinations with known HER2-positive malignancy
15970309|NCT03109964|Device|Bipolar coagulation forceps (ETHICON inc.)|Hemostasis of the base of the ovarian cyst by utilization of a bipolar coagulation device.
15970310|NCT03109964|Device|SURGIFLO hemostatic matrix (ETHICON inc.)|Hemostasis of the base of the ovarian cyst by utilization of a an absorbable gelatin based matrix known as SURGIFLO.
15970311|NCT03109951|Drug|Colonoscopy preparation using polyethylene glycol|Colonoscopy preparation using standard preparation with 2L of polyethylene glycol.
15970312|NCT03109925|Device|DC Lumi Bead, BTG|Embolic agent which is radio-opaque
15970313|NCT03109912|Behavioral|Personalized-Coaching Interventions|At the baseline fitness assessment, participants receive exercise prescriptions based upon their individual assessment. One of the ultimate exercise prescription goals is to achieve 30-minutes of an endurance-style exercise 5 times/week which may vary depending upon baseline fitness assessment. Aside from team sports, endurance-style exercise prescriptions may include simply walking, jump roping or stair climbing to more complex Tabata-style workouts. Two additional physical therapy (PT) 30-minute appointments are scheduled about 4-6 weeks and 8-10 weeks from enrollment. These 30-minute PT follow-up appointments will vary based on initial assessment and previous exercise prescription success but will include strength training for major muscles groups and/or flexibility exercises with yoga as well as reinforcement of previously learned techniques. PT will add additional individualized recommendations.
15970314|NCT03109912|Behavioral|Motivational Messages|Intervention participants are enrolled to receive motivational messages starting 14 days after enrollment via preferred contact method (SMS, telephone call and/or email) every 3-4 days over the 6-month study period.
15970315|NCT03109912|Behavioral|Online Exercise Tutorials|Participants are given access to Do More, B'More, Live Fit webpage which includes spotlighted exercises, instructional exercise photos and videos.
15970316|NCT03109912|Behavioral|Social Support and Peer Challenges|Participants are invited to join the Do More, B'More, Live Fit Activity Group via the FitBit Dashboard and are invited to friend the study team members and other exercise-intervention participants in order to take part in FitBit step-goal challenges.
15970317|NCT03109899|Behavioral|Sex Pro mobile Application|Mobile mHealth app that provides HIV risk assessment, home HIV/STI testing options, and PrEP uptake support for young Black MSM.
15970318|NCT03109886|Drug|Milciclib maleate|100 mg/day once daily, for 4 consecutive days a week in a 4-week cycle (4 days on/3 days off x q4 wks) for a total of 12 weeks (i.e. 3 cycles) unless patient refusal, consent withdrawal, Investigator's decision, unacceptable toxicity or death whichever occurs earlier. After the completion of three cycles, patients who, in the Investigator's judgment, are benefiting from treatment with milciclib, will resume treatment and will remain on study up to Day 180 from treatment start, unless withdrawal criteria are met earlier.
15970319|NCT03109873|Radiation|External Beam Radiation Therapy|Undergo External Beam Radiation Therapy
15970320|NCT03109873|Drug|Metformin Hydrochloride|Given orally
15970321|NCT03109873|Other|Placebo|Given orally
15970322|NCT03109860|Behavioral|Open-hidden|Administration of a treatment openly (in full view of the patient) vs hidden (without the patient's knowledge).
15970323|NCT03109847|Drug|Metformin Hydrochloride|Given Orally
15970324|NCT03109847|Other|Radioactive Iodine|Undergo radioactive iodine treatment
15970325|NCT03109847|Other|Placebo|Given orally
15970326|NCT03109834|Dietary Supplement|Meal replacement (MR)|"MR-WL group followed an energy-restricted diet with a balanced variety of nutrient-dense food of approximately 1200 kcal/d and was advised to replace two meals, i.e. breakfast and dinner, every day with two MR shakes, soups or bars and to prepare their own lunch during 3-month weight loss phase (phase 1).
~During 3-month weight stabilization phase (phase 2) MR-S group (MR group during weight stabilization phase) were encouraged to consume a self-directed well-balanced variety of nutrient-dense foods without meal intervention. MR counted to food choice option. The MR-S group was instructed to continue the implemented nutrition advice of weight loss phase.
~Duration: 6 months (phase 1 and phase 2: baseline I - 6.month)"
15970353|NCT03109678|Device|Crossover Ambu Aura-i™ / LMA ETT™|After unsuccessful blind intubation in the Ambu Aura-i™ / LMA ETT group: crossover design using the Ambu Aura-i™ mask in combination with the Rüsch Super Safety Silk™ tracheal tube
15970327|NCT03109834|Other|Control (C)|"During 3-month weight loss phase (phase 1) C-WL group followed an energy-restricted diet with a balanced variety of nutrient-dense food of approximately 1200 kcal/d without MR for weight control.
~During 3-month weight stabilization (phase 2) phase C-S group (C group during weight stabilization phase) were encouraged to consume a self-directed well-balanced variety of nutrient-dense foods without meal intervention. MR counted to food choice option. The C-S group was instructed to continue the implemented nutrition advice of weight loss phase.
~Duration: 6 months (phase 1 and phase 2: baseline I - 6.month)"
15970328|NCT03109834|Dietary Supplement|Verum|"Verum: Specific micronutrient composition with omega-3 fatty acids (capsules)
~Verum group followed an energy-restricted diet with a balanced variety of nutrient-dense food of approximately 1500 kcal/d and was advised to consume 3 verum-capsules twice a day (with breakfast and dinner) with 200 ml water during 6-month weight loss maintenance phase (phase 3).
~Duration: 6 months (6.month / baseline II - 12.month)"
15970329|NCT03109834|Other|Placebo|"Placebo group followed an energy-restricted diet with a balanced variety of nutrient-dense food of approximately 1500 kcal/d and was advised to consume 3 placebo-capsules twice a day (with breakfast and dinner) with 200 ml water during 6-month weight loss maintenance phase.
~Placebo contains no micronutrients and omega-3 fatty acids.
~Duration: 6 months (6.month / baseline II - 12.month)"
15970330|NCT03109821|Other|Home-based exercise|"The intervention reflects the standard rehabilitation practice at Elective Surgery Centre. 3 weeks after surgery the patients will receive a thorough instruction and supervision in the strength training exercises that they are to perform without supervision at their own homes the following 7 weeks. The instruction is conducted one-to-one by physiotherapists and supported by an instruction booklet with written and illustrated exercise descriptions. The exercises included are: hip abduction, flexion and extension with elastic band resistance and sit-to-stand and one-legged stance. The prescribed training load will be two sets with repetitions to failure and a relative load of 10 to 20 RM (Repetition Maximum), performed every second day (3-4 times a week).
~Exposure: Performed exercise dose will be quantified as the total physiological exercise stimulus (Time under tension summary dose) recorded by a sensor (BandCizer) attached to the elastic exercise band."
15970331|NCT03109808|Other|e-health strategy|"First, a personalized video of the patient's oral hygiene routine (toothbrushing and interdental hygiene) is recorded and made available to him-her via a cloud-based system. The patient is instructed to view it with his-her smartphone and/or tablet when brushing his-her teeth.
~Second, the patient is registered in a text-based recall system. This recall system will remind him-her the oral hygiene regimen suited to his-her personal situation and contains a link to his cloud-hosted video. 12 text messages for each patient will be sent over the course of the study (8 weeks). This is a two-way system as patients will be inquired about their compliance to oral hygiene. If the patient declare compliance, he-she will be congratulated (positive reinforcement). If the patient declares non-compliance, he-she will be informed he-she will be offered additional counselling at the next appointment."
15970332|NCT03109808|Other|Traditional Oral Hygiene Education|traditional oral hygiene education
15970333|NCT03109795|Drug|Clonidine Pill|sympathetic nerve activity blockade
15970334|NCT03109795|Drug|Hydrochlorothiazide|Blood pressure-lowering control condition
15970335|NCT03109769|Behavioral|Mobile phone application|
15970336|NCT03109769|Behavioral|Verbal oral hygiene instructions|
15970337|NCT03109756|Drug|OV101|Single-dose 5 mg OV101
15970338|NCT03109743|Behavioral|Sisters-GPS: Group Clinical Visits|Sisters-GPS will be involve group clinical visits where by the same group participants with meet with a clinician and behaviorist to receive education, self-management skills development, and clinical assessment over the seven weekly group visits. The content will focus specifically on HIV medications and medication adherence. Additionally, the intervention will involve a private social media website where participants will be able to engage with one another between group clinical visits. Participants will receive food and a roundtrip Metrocard at each group clinical visit.
15970339|NCT03109743|Behavioral|Control: One-on-one Adherence Counseling|For participants in the control arm, the counselor will provide standard-of-care adherence counseling, which includes education about ARVs and the importance of adherence, and addressing non-adherence including assessment of psychosocial barriers to adherence. For visits to the adherence counselor, participants will receive round-trip MetroCards as per clinic policy. Control arm participants will be expected to attend a minimum of three visits with the adherence counselor.
15970340|NCT03109730|Drug|ABI-H0731|A novel HBV core protein allosteric modifier (CpAM) which is being developed as a potential therapeutic advance for CHB patients
15970341|NCT03109730|Drug|Placebo for ABI-H0731|Sugar pill manufactured to mimic the ABI-H0731 tablet
15970342|NCT03109730|Drug|Entecavir|An antiviral medication used in the treatment of hepatitis B virus infection
15970343|NCT03109730|Drug|Tenofovir Disoproxil Fumarate|An antiviral medication used in the treatment of hepatitis B virus infection
15970344|NCT03109730|Drug|Pegasys|Used to treat adults with chronic hepatitis B virus who show signs of liver damage
15970345|NCT03109717|Drug|Monoamine Oxidase Inhibitor (MAOI)|Monoamine Oxidase Inhibitor
15970346|NCT03109704|Procedure|Supine upper thoracic spine thrust manipulation|The supine thrust manipulation will target the upper thoracic spine and will be performed as previously described. The patient will be asked to lace his or her fingers behind the neck and bring his or her elbows close together in front of the chest. The therapist will place one hand just below the targeted upper thoracic region (at either the T3 or T4 level) using a pistol grip or loose fist to make contact with both transverse processes of the T3 or T4 vertebrae. The therapist will then use his or her body to push down through the patient's upper arms to provide a high-velocity, low-amplitude thrust in the anterior-to-posterior direction.
15970347|NCT03109704|Procedure|Seated upper thoracic spine thrust manipulation|The seated thrust manipulation will target the cervicothoracic junction with the patient sitting with fingers laced behind the neck. The therapist will stand behind the patient and thread his or her arms through the patient's arms and clasp his or her hands near the C7-T1 level. The therapist will make contact with his or her chest against the patient's upper thoracic region to serve as a fulcrum. The patient will then be instructed to take a deep breath, and upon exhalation the therapist will apply a high-velocity, low-amplitude distraction thrust in a cephalad direction.
15970352|NCT03109678|Device|Crossover Ambu Aura-i™ / Rüsch Super Safety Silk™|After unsuccessful blind intubation in the Ambu Aura-i™ / Rüsch Super Safety Silk™ group: crossover design using the Ambu Aura-i™ mask in combination with the LMA ETT™ tracheal tube
15970354|NCT03109678|Device|Crossover FASTRACH™ / Rüsch Super Safety Silk™|After unsuccessful blind intubation in the FASTRACH™ / Rüsch Super Safety Silk™ group: crossover design using the FASTRACH™ mask in combination with the LMA ETT™ tube
15970355|NCT03109678|Device|Crossover FASTRACH™ / LMA ETT™|After unsuccessful blind intubation in the FASTRACH™ / LMA ETT™ group: crossover design using the FASTRACH™ mask in combination with the Rüsch Super Safety Silk™ tube
15970356|NCT03109665|Diagnostic Test|SD-OCT Angiography|SD-OCT Angiography
15970357|NCT03109665|Diagnostic Test|SD-OCT|SD-OCT
15970358|NCT03109652|Drug|Tranexamic Acid|"On the day of operation, same dose of IV tranexamic acid(TXA) is given to all subjects in three study groups. Oral TXA is given from postoperative day 1 only to experimental groups. Duration of oral TXA administration is different between two experimental groups. (5 days in IV TXA and Oral TXA 5 days group and 2 days in IV TXA and Oral TXA 2 days group)"
15970359|NCT03109639|Device|Conventional EUS FNA needle|Participants randomised to Group A will undergo tissues acquisition using the Conventional EUS FNA needle and then crossed over to receive the experimental Acquire EUS- FNB device.
15970360|NCT03109639|Device|Acquire FNB device|Participants randomised to Group B will undergo tissue acquisition using the experimental Acquire EUS FNB device and then crossed over to receive the conventional EUS FNA needle
15970361|NCT03109626|Dietary Supplement|DHA|
15970362|NCT03109613|Device|Positive end-expiratory pressure (PEEP)|level changes as per arm description
15970363|NCT03109600|Biological|Vi-DT (Bio Farma)|Typhoid Conjugate Vaccine
15970364|NCT03109600|Biological|Vi polysaccharide vaccine|Vi polysaccharide vaccine
15970365|NCT03109600|Biological|Influenzae vaccine|1 dose of Influenzae vaccine
15970366|NCT03109600|Biological|Pneumococcal conjugate vaccine|1 dose of Pneumococcal conjugate Vaccine
15970367|NCT03109587|Dietary Supplement|Vivomixx|900 billion of the following probiotic strains: L. acidophilus DSM24735; L. plantarum DSM24730; L. paracasei DSM24733; L. delbrueckii supsp. bulgaricus DSM24734, S. thermophilus DSM24731, B. longum DSM24736, B. breve DSM24732, and B. infantis DSM24737) maltose (polysaccharide used as food additive, produced from starch), and silicon dioxide (food additive)
15970368|NCT03109587|Dietary Supplement|Placebo|maltose (polysaccharide used as food additive, produced from starch), and silicon dioxide (food additive)
15970369|NCT03109574|Device|BioFlo DuraMax Chronic Hemodialysis Catheter|
15970370|NCT03109574|Device|Standard of Care Catheter|
15970371|NCT03109561|Other|Resting State Indirect Calorimetry|The investigator will measure the amount of oxygen participants breathe in and the amount of carbon dioxide they breathe out using a portable unit. Participants will be asked wearing a loose-fitting face mask that measures oxygen intake and carbon dioxide output.
15970372|NCT03109561|Genetic|ApoE|The investigator will conduct a genetic test on DNA isolated from from the participants blood. Participants will be asked to provide about 2 tablespoons.
15970373|NCT03109561|Diagnostic Test|Metabolism|To more accurately measure the amount of carbohydrates, fats and proteins that the participants bodies metabolize, participants will be asked to provide two urine samples (one at the beginning, and one at the end, of the study). The total amount of urine to be collected is approximately 4 teaspoons.
15970374|NCT03109561|Other|Cognitive Challenge|Participants will be asked to follow simple instructions that are displayed on computer screen.
15970375|NCT03109548|Other|Standard care initiated by the general practitioner|Patients are treated based on their symptoms and the research group does not interfere with this.
15970376|NCT03109535|Behavioral|Fitbit + Maptrek|Users receive a Fitbit Zip to wear daily. Users aslo receive the mHealth MapTrek game that places users in weekly walking races and sends automated text messages to users on a daily basis for the purpose of increasing daily physical activity.
15970377|NCT03109535|Behavioral|Fitbit only|Users receive a Fitbit Zip to wear daily.
15970378|NCT03109522|Procedure|axillary reverse mapping (ARM)|"ARM/SLNB: patient will be injected with technetium-99 radiolabelled colloid (Tc-99) into the subareolar area of breast, then 1-2 mls of blue dye (patent blue dye) injected subcutaneously into the medial ipsilateral arm, just proximal to the medial epicondyle of the elbow, at the start of the surgical procedure. the SLN(s) will be identified (hot node) and removed, and any blue lymph nodes and lymphatics will be preserved intact, and only removed or disrupted if there is 'crossover (i.e. the blue node is also the SLN) or if clinically suspicious for metastatic disease. ARM/ALND: 1-2 mls of blue dye will be injected subcutaneously into the medial ipsilateral arm at the start of the surgical procedure. Surgeons will perform a standard level I and II axillary dissection and any blue lymph nodes or lymphatics will be preserved intact, and only removed or disrupted if blue nodes are suspicious for metastatic disease."
15970379|NCT03109522|Procedure|Standard axillary surgery (SLNB or ALND)|The control group will have standard SLNB or ALND surgery without identifying or sparing upper-limb lymphatics and nodes (blue dye is not injected).
15970380|NCT03109509|Behavioral|Fitbit + Pokemon Go|Participants received a Fitbit Zip to wear daily for 8 weeks. Participants also received access to the Pokemon Go game.
15970381|NCT03109509|Behavioral|Fitbit Only|Participants received a Fitbit Zip to wear daily for 8 weeks.
15970382|NCT03109496|Other|Collection of body fluids/swabs|Middle ear, ear duct, anterior nare, nasopharynx, adenoids. Niches depend on accessibility for each individual participant.
15970383|NCT03109483|Other|Geriatric Activation Program Pellenberg|intensive multicomponent physical therapy week program
15970384|NCT03109457|Other|oral squamous cell carcinoma|Histological diagnosis of H&E stained sections will be performed according to WHO guidelines by 2 independent pathologists.
15970385|NCT03109444|Diagnostic Test|Hip Ultrasound|Both hips will be examined. The diagnostic examination for developmental dysplasia of the hip (DDH) incorporates 2 orthogonal planes: a coronal view in the standard plane at rest and a transverse view of the flexed hip at rest. It is acceptable to perform the examination with the infant in a supine or a lateral decubitus position. The anatomic coronal plane is approximately parallel to the posterior skin surface of an infant. The imaging plane is through the deepest part of the acetabulum (which includes visualization of the triradiate cartilage and the ischium posteriorly), the resulting image will be a coronal view in the standard plane. The standard plane is defined by identifying a straight iliac line, the tip of the acetabular labrum, and the transition from the os ilium to the triradiate cartilage. Acetabular morphology is assessed in this view and may be validated by measuring the acetabular alpha angle (≥60°). The femoral head coverage by the bony acetabulum should be >50%.
15970386|NCT03109431|Behavioral|Level 1|"Youth will receive 1-5 text messages per day for at least 12 months. Banks of about 750 messages (70-120 messages per domain) focus on the HIV Treatment Continuum, with messages focused on dedicated to healthcare, wellness, sexual health, drug use and medication reminders. Youth will be able to choose the time and frequency that they receive daily texts. Preferences for the timing and type of messages can be updated at 4-month assessment points.
~Youth will complete weekly monitoring surveys by text message. The survey will cover six domains related to the HIV Treatment Continuum. If YLH do not respond to the text, reminder messages will be sent to the youth. After three days of non-response a follow-up call by an interviewer will be made to the YLH."
15970387|NCT03109431|Behavioral|Level 2|"Youth will be enrolled in online, private discussion groups.
~Peer Support will be offered by fellow participants and/or Youth Advisory Board members that have been trained in basic information on HIV, STI, drug use, mental health, homelessness, and stigma; using social media to create wall posts and use chat functions; and, how to initiate conversations on sensitive topics. By posting and responding to messages, Peer Supporters will encourage and broadly guide conversation related to the HIV Prevention Continuum, and other relevant topics.
~Coaches and Project Coordinators will be available to provide factual information (as needed), and remove inappropriate content."
15970388|NCT03109431|Behavioral|Level 3|Youth will have be assigned to a Coach trained in a strengths--based Coaching intervention, as well as common foundational theory, principles and skills used in adolescent HIV Evidence-Based Interventions (EBI). Youth preferences will drive the intervention delivery - whether in-person, electronically via the phone, email, text message, social media private messaging.
15970389|NCT03109418|Drug|Ketamine|OSA patients receiving standard inhaled anesthesia combined with a low-dose ketamine infusion in which dosage will be based on ideal or adjust body weight
15970390|NCT03109418|Procedure|Control|OSA patients receiving standard inhaled anesthesia combined with normal saline
15970391|NCT03109405|Device|Stimulation-assisted venous access|Stimulation-assisted venous access
15970392|NCT03109405|Other|20 guage cannula for IV, tourniquet optional|Standard IV cannulation using 20 ga needle, and use of tourniquet at discretion of nurse performing IV cannulation
15970393|NCT03109392|Drug|Nebulized Lignocaine|2.5 ml of 4% lignocaine will be administered via nebulization prior to bronchoscopy
15970394|NCT03109392|Drug|Lignocaine spray|10 puffs of 10% (10mg/puff) lignocaine spray will be sprayed at 10 seconds intervals into the pharynx immediately prior to bronchoscopy
15970395|NCT03109392|Drug|Combined spray and nebulization|Combination of 2.5 ml of 4% lignocaine via nebulization prior to bronchoscopy and 2 puffs of 10% (10mg/puff) lignocaine spray sprayed at 10 seconds intervals into the pharynx immediately prior to bronchoscopy
15970396|NCT03109379|Drug|Trospium-Releasing Intravesical System (TAR-302-5018)|TAR-302-5018 is a passive, nonresorbable trospium-releasing intravesical system whose primary mode of action is the controlled release of trospium into the bladder over a 42-day period.
15970397|NCT03109366|Behavioral|Online patient-provider communication service|
15970398|NCT03109353|Drug|ECP with 5-aminolevulinic acid|extracorporeal photopheresis (ALA-ECP) using 5-aminolevulinic acid instead of psoralen (8-MOP) in a maximum of 10 treatment cycles
15970399|NCT03109340|Other|Supervised treadmill group (Group I)|An exercise prescription was developed for each woman on the basis of the data acquired from the baseline treadmill exercise test. Target HR corresponding to values of 50-70% VO2max (moderate-intensity) was determined by the submaximal treadmill test.The participants were instructed walking exercise at their target HR on a treadmill in Sports Rehabilitation Unit of Pamukkale University. HR was monitored by a Polar HR monitor (Polar Beat, Port Washington, NY).During 12 weeks, 5 days in a week and 30 minutes per day walking program was applied.
15970400|NCT03109340|Device|ECE PEDO pedometer (Group II)|Following a 10-minute rest after treadmill test, the participants were instructed to walk on the treadmill while maintaining their target heart rate. The number of steps taken in a minute was calculated using a criterion pedometer when target HR responses were reached. In this way, we determined the steps per minute required to moderate intensity walking for each participant. Detected individual step numbers were recorded to ECE PEDO for each person. Then participants were given the walking program with ECE PEDO giving audible feedback in case of any deviation from the range of steps per minute.During 12 weeks, 5 days in a week and 30 minutes per day walking program was applied.
15970401|NCT03109327|Diagnostic Test|Melanoma Detection System -MDS|Imaging of lesion using the MDS test.
15970402|NCT03109314|Drug|Donepezil|Donepezil will be administered to subjects three days before each training, and during training, to evaluate if donepezil improves the effectiveness of training.
15970403|NCT03109314|Behavioral|Single-letter training|Subjects will undergo training to identify single letters (10,000 trials, or 10 blocks per session for 10 sessions).
15970404|NCT03109314|Behavioral|Uncrowd training|Subjects will undergo training to identify letters closely flanked by other letters (10,000 trials, or 10 blocks per session for 10 sessions).
15970405|NCT03109301|Drug|Selumetinib (AZD6244 hyd sulfate) 50mg/dose|Selumetinib will be administered at a starting dose of 50 mg/dose orally in patients 18 years or older; drug will be given twice daily continuously in the absence of toxicity or disease progression, using 28-day cycles.
15970406|NCT03109301|Drug|Selumetinib (AZD6244 hyd sulfate) 25mg/m2|Selumetinib will be administered at a starting dose of 25 mg/m2/dose in children < 18 years of age; drug will be given twice daily continuously in the absence of toxicity or disease progression, using 28-day cycles.
15970407|NCT03109288|Drug|Pioglitazone|15-45 mg po qd
15970408|NCT03109288|Drug|clemastine fumarate|8 mg/day (divided into 3 doses of 2, 2, and 4 mg)
15970409|NCT03109288|Drug|Dantrolene|Up to 200 mg/day (divided into 3 doses of 50mg, 50mg, and 100 mg)
15970410|NCT03109288|Drug|Pirfenidone|"Up to 801 mg po tid. Slow titration over weeks based on tolerability:
~267mg po tid x >= 7d 534 mg po tid x >= 7d 801 mg po tid"
15970411|NCT03109275|Other|Single complete MRI intervention|MRI examination will comprise conventional T1 and FLAIR sequences, and advanced sequences such as rs-fMRI and High angular resolution MRI (HARDI).
15970412|NCT03109262|Procedure|Computed Tomography (CT)|As part of PET/CT and SPECT/CT scans.
15970413|NCT03109262|Procedure|Positron Emission Tomography (PET)|As part of PET/CT scan
15970414|NCT03109262|Device|90-Yttrium (Y-90) Glass Microspheres|Radiolabel for PET/CT scan
15970415|NCT03109262|Diagnostic Test|Technetium 99mTc albumin aggregated (99mTc-MAA)|Radiolabel for 99mTc-MAA SPECT/CT Scan
15970420|NCT03109236|Procedure|CD133 Cells Transplantation|Endothelial progenitor cells are harvested by CD133+ MACS (magnetic activated cell sorting) sort selection of bone marrow and a minimum of 1x 10^6 and up to 50-100 x 10^6 cells are transplanted to one lobe of the liver via a percutaneous catheter inserted into the portal venous system by percutaneous transhepatic approach for engraftment.
15970421|NCT03109223|Other|sole source nutrition|Infant formula
15970422|NCT03109210|Behavioral|Online Cognitive Behavioral Therapy (OCBT)|Cognitive behavioral therapy delivered via commercial online software.
15970423|NCT03109210|Behavioral|Therapist-directed Cognitive Behavioral Therapy (TCBT)|Cognitive Behavioral Therapy delivered via traditional, in-person interaction with a licensed mental health professional.
15970424|NCT03109197|Other|Biospecimin Collection|
15970425|NCT03109184|Behavioral|Project STRONG|The web-based program consists of a number of games, activities, and didactic information that teens move through with their parent. Didactic information introduces teens and parents to specific emotion management, communication, and problem solving strategies as well as sexual health and healthy relationship information. Games and activities allow parents and teens to practice and apply strategies to developmentally appropriate situations.
15970426|NCT03109171|Other|Laryngopharyngeal sensory test|The sensory measurements will include thresholds for psychophysical sensory thresholds at the velopharynx, hypopharynx and aryepiglottic folds
15970427|NCT03109158|Drug|NC-6004|NC-6004 provided by NanoCarrier
15970428|NCT03109158|Drug|Cetuximab|Commercially Available
15970429|NCT03109158|Drug|5-FU|Commercially Available
15970430|NCT03109145|Other|Menopause educational secure messaging|Participants read educational material about menopause and treatment option for menopause symptoms once a week using secure messaging on a electronic patient portal.
15970431|NCT03109132|Device|Oridion Smart CapnoLine® H Plus with Wedge cannula|The subjects will assess the comfort level of the different cannulas
15970432|NCT03109132|Device|Oridion Smart CapnoLine® Plus with Non-Wedge cannula|The subjects will assess the comfort level of the different cannulas
15970433|NCT03109132|Device|Experimental sample line Model 3|The subjects will assess the comfort level of the different cannulas
15970434|NCT03109132|Device|Experimental sample line Model 4|The subjects will assess the comfort level of the different cannulas
15970435|NCT03109132|Device|Experimental sample line Model 5|The subjects will assess the comfort level of the different cannulas
15970436|NCT03109132|Device|O2/CO2 cannula w/female luer (Westmed comfort plus #0504)|The subjects will assess the comfort level of the different cannulas
15970437|NCT03109119|Drug|Sevoflurane|The patients in the group S will be exposed to routine concentrations of sevoflurane during anaesthesia.
15970438|NCT03109119|Drug|Propofol|These patients will be induced with propofol 1.5 mg / kg and maintained with propofol infusion.
15970439|NCT03109106|Device|PCT Arm|PCT-guided antibiotic therapy per study protocol
15970440|NCT03109093|Drug|Blinatumomab|"Patients will receive blinatumomab at a dose of 28 µg/day as continuous intravenous infusion at constant flow rate for four weeks, followed by a two-week infusion free interval, defined as one treatment cycle. Up to of four cycles will be performed.
~In case of defined toxicities, the dose of blinatumomab may be reduced to 9µg/day.
~Patients with an MRD relapse may qualify to receive additional treatment with blinatumomab."
15970441|NCT03109080|Drug|Olaparib|five levels of dose, per os administration, twice daily each day
15970442|NCT03109080|Radiation|Radiation therapy|3D conformal radiotherapy or intensity-modulated radiotherapy (IMRT), Simultaneous Integrated Boost (SIB), postoperative radiotherapy
15970443|NCT03109067|Other|Standardized meal|Blood samples performed at 5 different times : H0 before the meal, H2, H4, H6 and H8 after the meal
15970444|NCT03109054|Diagnostic Test|State-Trait Anxiety Inventory Test|All patients will take a State-Trait Anxiety Inventory Test. After the test patients will enroll low or high anxiety level.
15970445|NCT03109041|Device|CivaSheet|The FDA Cleared CivaSheet Directional Pd103 Brachytherapy Source is a planar radiation source which utilizes gold shielding in its construction. This device is radioactive on one side only, and is capable of safely delivering high doses of radiation to target areas even when placed directly adjacent to sensitive, healthy tissue or critical structures.
15970446|NCT03109028|Behavioral|Peer-to-Peer-Groupintervention|"Target group: Adult participants with mild to moderate depressive symptoms who prefer therapists with the same cultural background.
~Therapists: Recruitment of psychosocial counselors within refugee community who have sufficient German or English language knowledge. Counselors will be trained for a time period of two months.
~Content: Vulnerability and resilience factors; Self-efficacy strategies; Causes and consequences of stress; Possibilities on accelerating the integration process; Strategies preventing violence and radicalization Form of therapy: Group-based intervention for a time period of three months; Two times per week with each session enduring 90 minutes; Group size between 8-10 participants; Headed by two psychosocial counselors."
15970447|NCT03109028|Behavioral|Smartphone-based-Intervention|"Target group: Participants with moderate depressive symptoms who prefer an internet-based intervention.
~Content: Five modules with 20 exercises elaborating on psycho-education, treatment options, self-management and diagnostics.
~Form of therapy: Participants receive regular emails and sms to encourage steady participation via the internet-based smartphone-application. Weekly questionnaires ascertain the degree of participants symptomatology."
15970448|NCT03109028|Behavioral|Gendersensitive-Groupintervention|"Target group: Vulnerable group of adult women while taking cultural characteristics into account Therapists: Recruitment of psychosocial counselors (similar to Peer-to-Peer-Intervention); Training and supervision of gender-specific aspects.
~Content: Focus on psycho-education which consider women specific topics such as gender-differences in symptoms and prevalence in psychic stress related and trauma disorders; physical, psychic and psychosocial consequences of traumatic and violent experiences; gender-specific risk and safety factors; stress and emotional self-regulation Form of therapy: Group-based intervention for a time period of three months; Two times per week with each session enduring 90 minutes; Group size between 8-10 participants; Headed by two female psychosocial counselors."
15970487|NCT03108729|Drug|Eslicarbazepine acetate|Eslicarbazepine acetate tablets, taken once daily for 1 year. The daily maintenance dose will be within the range of 300 mg to 1600 mg ESL, and is determined by body weight, clinical response and tolerability.
15970488|NCT03108716|Procedure|hamate hook removal|The patients were assigned to treat with hamate hook removal.
15970449|NCT03109028|Behavioral|Empowerment-Groupintervention|"Target group: Gender-sensitive group with mild to moderate depressive symptoms. Therapists: Psychologists and doctors in psychotherapeutic advanced training; The therapist-training lasts for three months with continued supervision during the intervention.
~Content: Low-threshold intervention based on the treatment of depression; psycho-education about psychic burdens, trauma, stress and grief as well as vulnerability and resilience factors; Problem solving and self-actualization strategies.
~Form of therapy: Group-based intervention for a time period of two months; Two times per week with each session enduring 90 minutes; Group size between 8-10 participants;"
15970450|NCT03109028|Behavioral|Adolescent-Groupintervention|"Target group: Adolescent participants with moderate depressive symptoms. Therapists: Two child and adolescent psychiatrists with translators or two native speaking child and adolescent psychotherapists.
~Content: Elements which are based on the START-Manual13 teaching emotion recognition and emotion regulation; Foundations are based on Dialetical behavior therapy; Specific focus lies on the use of mindfulness; Additionally the social network of the participants will receive psycho-education; Professional helpers in facilities will acquire E-learning elements of the SHELTER-program (Safety and Help for Early Adverse Life events and Traumatic Experiences in minor refugees)"
15970451|NCT03109028|Other|Treatment as Ususal|Participants will receive the currently conducted routine and standard psychiatric health care. This involves ambulatory and stationary treatment by board certificated psychiatrists and psychotherapists.
15970452|NCT03109015|Drug|Sunitinib|Patients randomized to sunitinib schedule 4/2 will receive sunitinib at 50 mg daily for 4 weeks on, followed by 2 weeks off, per standard of care. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 4 weeks and 12 weeks.
15970453|NCT03109015|Drug|Sunitinib|Patients randomized to sunitinib schedule 2/1 will receive sunitinib 50 mg daily for 2 weeks on, followed by 1 week off. Cardiopulmonary Exercise Testing (CPET) will be performed at baseline, 5 weeks and 12 weeks.
15970454|NCT03108989|Drug|Sugammadex|After the end of surgery, sugammadex of 2 mg/kg will be administered to reverse neuromuscular blockade.
15970455|NCT03108989|Drug|Neostigmine|After the end of surgery, neostigmine will be administered to reverse neuromuscular blockade.
15970456|NCT03108976|Other|Behavioral assessments|Kinematics measures, concomitant to Magnetoencephalography (MEG, measures oscillatory rhythms in the brain) and Magnetic Resonance Imaging (MRI, used to provide an anatomical image of each participant's brain to be coregistered with oscillatory measurements) recordings, enable to track sensori-motor learning based on performance, and oscillatory changes (with high temporal and spatial resolution).
15970457|NCT03108976|Other|Magnetoencephalography (MEG)|Kinematics measures, concomitant to Magnetoencephalography (MEG, measures oscillatory rhythms in the brain) and Magnetic Resonance Imaging (MRI, used to provide an anatomical image of each participant's brain to be coregistered with oscillatory measurements) recordings, enable to track sensori-motor learning based on performance, and oscillatory changes (with high temporal and spatial resolution).
15970458|NCT03108976|Other|Magnetic Resonance Imaging (MRI)|Kinematics measures, concomitant to Magnetoencephalography (MEG, measures oscillatory rhythms in the brain) and Magnetic Resonance Imaging (MRI, used to provide an anatomical image of each participant's brain to be coregistered with oscillatory measurements) recordings, enable to track sensori-motor learning based on performance, and oscillatory changes (with high temporal and spatial resolution).
15970459|NCT03108963|Drug|L-carnitine and Metformin|L-carnitine plus Metformin was given Obese PCOS Women trying induction of ovulation with clomiphene citrate.
15970460|NCT03108963|Drug|placebo|placebo was given Obese PCOS Women trying induction of ovulation with clomiphene citrate.
15970461|NCT03108950|Behavioral|Movement to Music|The Movement to Music classes are composed of a set of exercises tailored to the specific needs and capabilities of each target group. The class will consist of and aerobic component and a strength component performed to varying music tempos. All movements will be choreographed by qualified dance instructors. Intervention is delivered using video-conferencing to connect the participant to their instructor.
15970462|NCT03108937|Drug|Dexmedetomidine|Patients in the experimental group will receive Dexmedetomidine during surgery.
15970463|NCT03108937|Drug|saline|Patients in the control group will receive saline but not Dexmedetomidine during surgery.
15970464|NCT03108924|Drug|Gefapixant|After an overnight fast participants receive a single oral dose of 50 mg gefapixant, in one 50 mg tablet.
15970465|NCT03108911|Other|Best Practice|Receive standard diet
15970466|NCT03108911|Procedure|Biospecimen Collection|Provide stool sample
15970467|NCT03108911|Other|Dietary Intervention|Receive GFD
15970468|NCT03108911|Other|Laboratory Biomarker Analysis|Correlative studies
15970469|NCT03108885|Other|Blood and Tissue Collection|Blood DNA will be isolated from plasma. Tumor DNA will be purified with a kit and amplified regions of 10 genes discovered to by mutated in whole exome sequencing.
15970470|NCT03108872|Device|left atrial appendage occlusion|Percutaneous exclusion of left atrial appendage with Watchman or ACP devices
15970471|NCT03108872|Drug|New oral anticoagulants|Include dabigatran, rivaroxaban, apixaban and edoxaban
15970472|NCT03108846|Drug|Escitalopram|5-15 mg/day (target: 15mg/day if tolerated)
15970473|NCT03108846|Drug|Placebo|Masked placebo
15970474|NCT03108833|Drug|Recombinant Human Prourokinase|The drug is used for intravenous thrombolysis therapy
15970475|NCT03108833|Drug|Alteplase|The drug is used for intravenous thrombolysis therapy
15970476|NCT03108820|Behavioral|TMH Intervention|Home visits and close interaction with injured patient to assure plan for care is being followed.
15970477|NCT03108820|Other|Usual Care|Review hospital discharge and rehabilitation plan, identification of primary care provider, provision of educational materials on communication skills, caregiver coping skills, and legal and financial advice.
15970478|NCT03108807|Diagnostic Test|D-dimer test|D-dimer test
15970479|NCT03108781|Drug|Lavender Oil|Lavender Oil twice a day; one month on the face and one month on the legs
15970480|NCT03108781|Drug|sunflower oil|placebo twice a day (sunflower oil); one month on the face and on month on the legs
15970481|NCT03108768|Device|Hearing Aid (Successor of Phonak Virto V)|The successor of Phonak's In-The-Ear (ITE) hearing aid Virto V will be fitted to the participants individual hearing loss.
15970482|NCT03108768|Device|Hearing Aid (Phonak Virto V)|Phonak's In-The-Ear (ITE) hearing aid Virto V will be fitted to the participants individual hearing loss.
15970483|NCT03108755|Drug|ASP7713|oral
15970490|NCT03108716|Other|short-arm tube-type plaster fixation|The patients were assigned to treat with short-arm tube-type plaster fixation (conservative treatment).
15970491|NCT03108703|Radiation|SBRT|35-40 Gy delivered in 5 fractions
15970492|NCT03108690|Drug|Continuous infusion of beta-lactam antibiotics .|Beta-lactam antibiotic will be administered as continous infusion.
15970493|NCT03108690|Other|Therapeutic drug monitoring of beta-lactam antibiotics.|Dosage of beta-lactam antibiotics will be adjusted according to serum concentration.
15970494|NCT03108677|Other|Blood samples|15 ml peripheral blood
15970495|NCT03108664|Drug|SYL1001 ophthalmic solution|1 drop in the affected eye
15970496|NCT03108664|Drug|Vehicle opthalmic solution|1 drop in the affected eye
15970497|NCT03108651|Other|Case|Motivational message will be administrated.
15970498|NCT03108638|Behavioral|R3 Supervisor Implementation Strategy|Supervisors will be trained to provide supervision to their caseworkers using R3 principles and strategies. Monthly monitoring and remote coaching will be provided.
15970499|NCT03108625|Drug|Vortioxetine|Target dose is 10 mg/day; the dose can be down- or uptitrated to 5, 15, or 20 mg/day.
15970500|NCT03108612|Diagnostic Test|Análisis de carga de trabajo (ACT)|Semi-structured interview for detecting possible occupational etiology of an upper limb musculoskeletal disease that has been reported (by the worker) as possibly of occupational origin. The instrument is called Workload Analysis Instrument (WAI) or Análisis de Carga de Trabajo (ACT).
15970501|NCT03108599|Other|Enhanced Cab|The cab engineering intervention includes the introduction of an active suspension seat and a therapeutic mattress system. After a baseline phase, the intervention arm will receive the enhanced cab intervention alone, and then the enhanced cab plus a behavioral sleep intervention.
15970502|NCT03108599|Behavioral|Fit4Sleep|The behavioral sleep intervention includes a friendly dyad-based physical activity competition; self-monitoring and logging of physical activity, sleep hygiene behaviors, and sleep; and individual coaching. The intervention arm will receive the behavioral sleep intervention in combination with the enhanced cab intervention.
15970503|NCT03108586|Procedure|Dental treatment|Dental treatment of all dental needs present in adults related or not to the dental caries
15970504|NCT03108586|Procedure|Dental treatment|Dental treatment of all dental needs present in adults related or not to the dental caries
15970505|NCT03108560|Procedure|sublobar resection|Patients receive sublobar resection, which includes wedge resection and segmentectomy.
15970506|NCT03108560|Procedure|lobectomy|patients receive lobectomy
15970507|NCT03108547|Other|Determination of scalp hair steroids|
15970508|NCT03108534|Drug|CHF1535 NEXThaler|Rescue treatment
15970509|NCT03108534|Drug|CHF1535 pMDI|Rescue treatment
15970510|NCT03108534|Drug|Placebo|Rescue treatment
15970511|NCT03108521|Drug|Sitagliptin|100mg.QD for 3 months
15970512|NCT03108508|Dietary Supplement|Prod1|60 mL of product (water, silicic acid, Equisetum Arvense, Rosmarinus officinalis) (Silicic acid) equivalent to 21.6 mg of elemental silicon.
15970513|NCT03108508|Dietary Supplement|Prod2|1.4 g of product (Orthosalicic acid) equivalent to 21.6 mg of elemental silicon
15970514|NCT03108508|Dietary Supplement|Prod3|120 mL of product (Aloe barbadensis Miller, organic silicon, potassium sorbate, cítric acid) (Organic silicon) equivalent to 21.6 mg of elemental silicon
15970515|NCT03108495|Biological|LN-145|A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes.
15970516|NCT03108495|Biological|LN-145 + pembrolizumab|A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. The first dose of anti-PD-1 immunotherapy will be administered following tumor resection.
15970517|NCT03108482|Drug|Co-crystal E-58425 (Tramadol/Celecoxib)|Co-crystal E-58425 (Tramadol/Celecoxib): Two immediate release oral over-encapsulated tablets of 100 mg, every 12 hours for 48 hours.
15970518|NCT03108482|Drug|Tramadol (Ultram®)|Tramadol: One immediate release oral over-encapsulated tablet of 50 mg, every 6 hours for 48 hours.
15970519|NCT03108482|Drug|Celecoxib (Celebrex®)|Celecoxib: One immediate release oral over-encapsulated capsule of 100 mg, every 12 hours for 48 hours.
15970520|NCT03108482|Drug|Placebo|Placebo 100 mg or 200 mg oral over-encapsulated tablets every 6 hours for 48 hours.
15970521|NCT03108469|Drug|IONIS-PKKRx (ISIS 546254)|Those randomized to IONIS-PKKRx (ISIS 546254) will receive subcutaneous injections containing 1.00 mL (200mg) of IONIS- PKKRx (ISIS 546254) weekly for weeks 1-16.
15970522|NCT03108469|Other|Placebo|Those randomized to placebo will receive subcutaneous injections 1.00 mL (200mg) weekly for weeks 1-16.
15970523|NCT03108456|Device|Orbital Atherectomy|Vessel preparation with Orbital Atherectomy followed by balloon pre-dilatation
15970524|NCT03108456|Device|Balloon|Vessel preparation with conventional and/or specialty balloons
15970525|NCT03108443|Diagnostic Test|Optical Coherence tomography angiography|All subjects will have OCT angiography imaging performed
15970526|NCT03108430|Other|Risk factors and incidence of IP after inhalation|Calculate the annual incidence of PI, the incidence of PI in inhaled patients (in each subgroup), and analyze the risk factors by logistic regression, based on the number of patients hospitalized during the study period.
15970527|NCT03108417|Device|continuous negative external pressure|continuous negative external pressure will be applied to the anterior neck at night
15970528|NCT03108404|Other|Validation of a diagnostic test|Validation of a diagnostic test
15970529|NCT03108391|Device|Ambu AuraGain|
15970530|NCT03108391|Device|LMA Supreme|
15970531|NCT03108378|Procedure|Surgery|hip, shoulder or knee replacement surgery, limb amputations or other orthopedic surgical procedures
15970532|NCT03108365|Device|Axiostat|"Axiostat® is a sterile, non-absorbable haemostatic dressing intended to control profuse bleeding within minutes of application by providing an active mechanical barrier to the wound site.
~Axiostat® stops moderate to severe bleeding due to cuts, abrasions, lacerations, venous/arterial punctures and more. Mechanism of action is such that Axiostat® is an extremely positive dressing that becomes very sticky in the presence of negatively charged blood and thus seals the wound area."
15970533|NCT03108365|Device|Cotton Gauze|Size: 1 x 1 cm
15970534|NCT03108352|Drug|Conbercept ophthalmic injection|
15970535|NCT03108352|Other|sham injection|
15970536|NCT03108339|Other|Guideline recommended physiotherapy care|The intervention will follow current care i.e. guideline informed intervention used by physiotherapists in the treatment of LBP in primary health care. The intervention will use a pragmatic approach and follow a framework of: 1) information of return to activity and to stay active 2) instruction on posture in loaded and unloaded positions 3) information on work and leisure based positions in activity and sitting 4) information on good sleeping position 4) instruction of an individualized exercise program based on findings from the examination enhancing core control 5) a choice of exercises as a home training program. Manual methods may if necessary be used. Choice of treatment, choice of exercises (loaded, unloaded) and also number of treatments is logged and noted.
15970537|NCT03108326|Biological|Stelara, Remicade, Entyvio, Humira, Remsima, Flixabi, Inflectra|The data of Crohn´s Disease (CD)-patients on Ustekinumab will be compared in an explorative analysis with CD-patients on other Biologics.
15970538|NCT03108313|Drug|aloe vera toothpaste|herbal toothpaste used to decrease salivary streptococcus bacterial count
15970539|NCT03108313|Drug|fluoride toothpaste|chemical toothpaste used to decrease salivary streptococcus bacterial count
15970540|NCT03108300|Drug|Propranolol Hydrochloride|propranolol hydrochloride is a beta-adrenergic receptor blocker
15970541|NCT03108300|Drug|Doxorubicin|Doxorubicin is a chemotherapy which will be injected by a dose 60 mg per meter square of body surface area to be repeated every 21days
15970542|NCT03108287|Drug|RAK therapy|rabeprazole 20mg, amoxicillin 1g and clarithromycin 500mg twice-daily
15970543|NCT03108287|Drug|RBAK therapy|rabeprazole 20mg, amoxicillin 1g and clarithromycin 500mg, bismuth subcitrate 360mg twice-daily
15970544|NCT03108274|Drug|Danicopan|Oral tablet.
15970545|NCT03108274|Drug|Midazolam|Oral syrup.
15970546|NCT03108274|Drug|Fexofenadine|Oral tablet.
15970547|NCT03108274|Drug|Mycophenolate Mofetil|Oral tablet.
15970548|NCT03108248|Drug|ethiodized oil; doxorubicin;Gelfoam;|Conventional TACE was performed in both groups as follows. First, multiple angiographies were performed to detect the hepatic arterial anatomy and the possible feeding arteries of tumor, selective catheterization of the artery feeding the tumors was performed. A mixture of ethiodized oil was injected, followed by injection of Gelfoam particles.
15970549|NCT03108248|Device|stent; idoine-125|In the ISP-TACE group, stent placement was performed one week before TACE. Under fluoroscopic and ultrasonic guidance, the outer stent was firstly placed at the site of the obstructed portal vein, and a self-expandable nitinol stent was immediately followed through a same 10-F sheath.
15970550|NCT03108235|Behavioral|HOM-HEMP|a 6-week nurse-led, home-based self-management psychosocial education programme comprising of a specifically developed HF education and self-management toolkit, three biweekly home visits by the research nurse.
15970551|NCT03108235|Behavioral|HOM-HEMP with smartphone app|"a 6-week nurse-led, home-based self-management psychosocial education programme comprising of a specifically developed HF education and self-management toolkit, three biweekly home visits by the research nurse. In addition, participants will receive a smartphone app.
~The smartphone will be used to monitor their health data (such as weight, and blood pressure). The data will be synchronized to a web-connected portal on a remote server. The research nurse would be able to access your data through the web-connected portal and provide consultation through scheduled tele or video conference."
15970552|NCT03108235|Behavioral|Standard Care|standard care provided by the hospital. It consists of all nursing, medical, and follow-up services as needed.
15970553|NCT03108222|Other|Phosphorus Absorption Test|Subjects will undergo a radiophosphorus (P-33) absorption test over two days, that will include an oral administration of P-33 on the 1st day of the test, and an IV administration of P-33 on the 2nd day of the test. P-33 activity from serial serum and urine collections will be determined by scintillation counting, and fractional phosphorus absorption calculated by kinetic modeling.
15970554|NCT03108209|Other|Photoderm Max lait SPF50+|Subjects apply Photoderm Max lait SPF50+ at the beginning of their treatment by Vemurafenib/Cobimetinib in prevention of phototoxicities
15970555|NCT03108209|Other|Photoderm Max Stick SPF50+|Subjects apply Photoderm Max Stick SPF50+ at the beginning of their treatment by Vemurafenib/Cobimetinib in prevention of phototoxicities
15970556|NCT03108196|Procedure|sigmoid|The serosal layer with smooth muscle was detached from a 15 cm sigmoid segment submucosal layer and removed continuously. Only the mucosal and submucosal layers were preserved. Approximately 2 cm of the taeniae and serosal layer were preserved to strengthen the urethra-neobladder anastomosis at the central portion of the isolated sigmoid and at the two ends for the ureter-neobladder anastomosis. The ureters were subsequently implanted in antirefluxing fashion in a submucosal tunnel. The ureter-neobladder anastomoses were protected with a 6Fr Single J® stent. The two ends of the sigmoid were closed with the embedded seromuscular layer. The neobladder was anastomosed to the urethra after that.
15970557|NCT03108196|Procedure|ileal|The isolated 70 cm terminal ileum segment is arranged in either an M or W shape and is opened along the antimesenteric border except for a 5 cm section where the incision is curved to make a U-shaped ﬂap. The four limbs of the M or W are then sutured to one another with a running absorbable suture. A small full-thickness segment of bowel is excised for the urethral anastomosis. Once the ileal neobladder is situated and the urethral sutures are tied, the ureters are implanted from inside the neobladder through a small incision in the ileum. The remaining portion of the anterior wall is then closed with a running absorbable suture. Ureteroileal anastomosis were performed with a freely refluxing, open end-to-side method at each end of the W.
15970558|NCT03108183|Diagnostic Test|x-rays|To get further and actual information about periapical lesions, different x-rays will be done (panoramic radiographic, small picture ray, cone beam computed tomography). Furthermore a periodontal status will be performed.
15970559|NCT03108170|Other|perineal massage program|The participant will perform digital massage of her perineal area 5 minutes daily starting four weeks before delivery till her actual labour day
15970560|NCT03108170|Other|Pelvic floor muscle exercise program|The participant will perform pelvic floor muscle exercise daily starting four weeks before delivery till her actual labour day
15970561|NCT03108170|Other|Educational pelvic floor dysfunction prevention program|This educational pelvic floor dysfunction prevention program includes instructions about: control of her weight, adequate cleaning for the perineal area, adequate fluid intake, smoking cessation, right posture and frequency of micturition and adequate ingestion of fiber to avoid constipation
15970726|NCT03106805|Procedure|early insertion|insertion at 4th postpartum week
15970562|NCT03108157|Procedure|Endometrial scratch|Patients included in the study group will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before embryo transfer.
15970563|NCT03108144|Behavioral|Brief alcohol intervention|The intervention is a clinical decision support system (CDSS) that provides a computerized prompt in the clinic's online portal. The CDSS prompts a practitioner to intervene when a patient is screening above recommended drinking guidelines. The prompt appears as an alert message, recommending intervention. The portal suggests scripted brief intervention language, designed based on the College of Family Physicians of Canada and Canadian Centre on Substance Abuse's resource on conducting evidence-based Screening, Brief Intervention, and Referral to Treatment (SBIRT) guidelines.
15970564|NCT03108131|Drug|Atezolizumab|Given IV
15970565|NCT03108131|Drug|Cobimetinib|Given PO
15970566|NCT03108105|Device|AOS-C2001-B|A new 2-piece appliance composed with 2 parts: a base plate and an ostomy collection special pouch (1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day)
15970567|NCT03108092|Other|STRIP intervention|The STRIP intervention consists of 9 steps: 1. structured history taking of medication 2. recording medication and diagnoses in STRIPA 3. structured drug review based on the STRIPA with the integrated Screening Tool of Older Person's Prescriptions (STOPP)/ Screening Tool to Alert Doctors to the Right Treatment (START) criteria 4. communication and discussion of the structured drug review with prescribing physician with possible adaptation of the recommendation 5. shared decision-making with the patient with possible adaptation of the recommendation 6. optional revision based on new accumulating data during hospitalisation (e.g. new diagnoses, adverse drug reactions) 7. generation of general practioner (GP) report 8. delivery of the report to the patient and to the GP (optional additional direct communication) 9. follow-up
15970568|NCT03108092|Other|Control|Standard care in the department where the trial is conducted
15970569|NCT03108079|Device|Cystosure Urinary Access System|"Demonstrate the 3D bladder wall anatomy with 300 cc of fluid infused with each of the following bladder drainage mechanisms
~The traditional Foley catheter (Catheter A)
~The novel FDA approved Cystosure catheter (Catheter B)
~Compare the fluid flow pattern during bladder drainage for
~The traditional Foley catheter (Catheter A)
~The novel FDA approved Cystosure catheter (Catheter B)
~Compare the 3D bladder wall anatomy after emptying the bladder with
~The traditional Foley catheter (Catheter A)
~The novel FDA approved Cystosure catheter (Catheter B)"
15970570|NCT03108079|Device|Foley Catheter|"Demonstrate the 3D bladder wall anatomy with 300 cc of fluid infused with each of the following bladder drainage mechanisms
~The traditional Foley catheter (Catheter A)
~The novel FDA approved Cystosure catheter (Catheter B)
~Compare the fluid flow pattern during bladder drainage for
~The traditional Foley catheter (Catheter A)
~The novel FDA approved Cystosure catheter (Catheter B)
~Compare the 3D bladder wall anatomy after emptying the bladder with
~The traditional Foley catheter (Catheter A)
~The novel FDA approved Cystosure catheter (Catheter B)"
15970571|NCT03108066|Drug|PT2385 Tablets|PT2385 inhibits HIF-2α and is a novel approach to treatment of VHL disease-associated ccRCC.
15970572|NCT03108053|Procedure|Semirigid Ureteroscopy (URS) With Guide Wire|Semirigid URS is the operations used for ureteral stone disease. In routine practice it is most commonly done with the use of a guide wire. It is conducted with ureteroscope and stone is disintegrated most commonly with lasers.
15970573|NCT03108053|Device|Semirigid Ureteroscopy (URS) Without Guide Wire|Semirigid URS is the operations used for ureteral stone disease . It is conducted with ureteroscope and stone is disintegrated most commonly with lasers.
15970574|NCT03108027|Drug|Treatment A: Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose)|Matching placebo (morning dose) and QVM149 150/50/80 μg (evening dose)
15970575|NCT03108027|Drug|Treatment B: QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose)|QVM149 150/50/80 μg (morning dose) and matching placebo (evening dose)
15970576|NCT03108027|Drug|Treatment C: Placebo (morning dose) and placebo (evening dose)|Placebo (morning dose) and placebo (evening dose)
15970577|NCT03107988|Drug|Lorlatinib|Lorlatinib will be given orally once daily continuously in 28-day cycles. Lorlatinib will be provided as 5 mg or 25 mg tablets.
15970578|NCT03107988|Drug|Cyclophosphamide|Cyclophosphamide 250mg/m2/day will be administered as a 30 minute IV infusion on days 1-5 of each cycle
15970579|NCT03107988|Drug|Topotecan|Topotecan 0.75mg/m2/day will be administered as a 30 minute IV infusion immediately following cyclophosphamide on days 1-5 of each cycle
15970580|NCT03107975|Biological|human amniotic epithelial cells|intrathecal injection of human amniotic epithelial cells
15970581|NCT03107962|Drug|Pembrolizumab (PD-1 Blocking Antibody)|pembrolizumab 2mg/kg, ivgtt (intravenously guttae), d1. Every three weeks for one cycle and two cycles are required at least. Efficacy and safety were evaluated every two cycles.
15970582|NCT03107949|Device|Lungpacer DPTS (Diaphragm Pacing Therapy System)|Lungpacer Diaphragm Pacing therapy (DPTS) will be conducted in daily sessions until the patient has been extubated or day 30 if not extubated.
15970583|NCT03107936|Behavioral|smokeSCREEN game|smokeSCREEN is web-based videogame intervention focused on tobacco use prevention in teens. The game has 1.5-2 hours of unique game play and focuses on combustible cigarettes, e-cigarettes, and flavored tobacco products.smokeSCREEN. Guided by the social cognitive theory and the theory of planned behavior, smokeSCREEN addresses a range of challenges that teens often face involving peer pressure and the use of tobacco products. Participants are provided access to the smokeSCREEN game through a private, password-protected website link and instructed to complete the game.
15970584|NCT03107923|Diagnostic Test|Dobutamine stress test|Test of myocardial reserve
15970585|NCT03107910|Behavioral|Stigma and Structural Interventions|Stigma focused counseling to address HIV anticipated stigma and online video chatting for HIV/STI testing will be assessed. Stigma and Structural Interventions
15970586|NCT03107910|Behavioral|Health Information Seeking|Seeking and evaluating online health information will be assessed.
15970588|NCT03107884|Drug|Metformin (Bed Rest)|A clinical oral dose of Metformin will be given to participant daily during bed rest
15970589|NCT03107884|Drug|Placebo (Bed Rest)|Placebo-comparator. The same quantity of non-active tablets will be given at the same time of day as the Metformin treatment group
15970590|NCT03107884|Drug|Metformin (2 week run-in only)|A clinical oral dose of Metformin will be given to participant daily during a two week run-in period only.
15970591|NCT03107884|Drug|Placebo (2 week run-in only)|Placebo-comparator. The same quantity of non-active tablets will be given at the same time of day as the Metformin 2 week run-in treatment group.
15970592|NCT03107871|Drug|Valganciclovir|Valganciclovir is supplied as a powder for reconstitution into an oral solution. The reconstituted solution formulation comprises the following excipients: Povidone K30, fumaric acid, sodium benzoate, saccharin sodium, mannitol, flavor, and purified water.
15970593|NCT03107871|Drug|Simple Syrup|Simple Syrup contains sucrose 85% weight by volume, purified water, and methyl paraben as a preservative along with natural preservatives. It will be flavored to match the flavor of valganciclovir.
15970594|NCT03107858|Drug|Norepinephrine|Norepinephrine infusion will be used at a starting dose of 0.05μg/kg/min. Dose range: 0.05 -0.15 μg/kg/min. Infusion will be started with arterial decamping and continues till 24 hours postoperative
15970595|NCT03107858|Drug|Dopamine|Dopamine infusion will be used at a starting dose of 5μg/kg/min. Dose range: 5 -15 μg/kg/min. Infusion will be started with arterial decamping and continues till 24 hours postoperative
15970596|NCT03107845|Behavioral|Cognitive Behavior Therapy|Treatments are conducted by cognitive-behavioral therapists in training with different levels of experience as well as licensed cognitive-behavioral therapists with several years of experience. The treatment approach is based on cognitive-behavioral manuals and principles.
15970597|NCT03107845|Behavioral|CBT plus Feedback|Therapists of the IG1 are provided with information about the initial status concerning symptoms (BSI & OQ-30), interpersonal functioning (IIP-32 & OQ-30) as well as diagnoses specific symptoms (GAD-7 or PHQ-9). Beside the status measures, also individual progress information on the symptom level (HSCL-11 each session) is provided to the therapist. Randomized controlled trial to evaluate the effects of personalized prediction and adaptation tools on treatment outcome in outpatient psychotherapy. This group is a matched sample.
15970598|NCT03107845|Behavioral|CBT plus Feedback plus CST|"Additional to the intervention group CBT and Feedback therapists will be provided with additional clinical support tools (CST) which are designed to facilitate treatment selection and treatment adaptation. The causes of deterioration will be assessed and therapists will be provided with additional treatment recommendations and material to help preventing treatment failure for a specific patient. During treatment the clinical support tools will be provided in the problem fields: risk/suicidality, motivation / treatment goals, therapeutic relationship, social support / critical life events, and emotion regulation / self regulation."
15970599|NCT03107832|Procedure|thoracic epidural anesthesia procedure|general anesthesia procedure
15970600|NCT03107819|Diagnostic Test|Plasma and urine metabolomics|Through the use of high-pressure liquid chromatography and mass spectrometry, quantitative measurements of targeted metabolites associated with amino acids, methylation, acetylation and the tricarboxylic acid (TCA) cycle will be analyzed on the blood and urine specimens.
15970601|NCT03107806|Device|OptiScanner®|"Glucose monitoring by OptiScanner® for 48 h
~Glucose lowering intervention (insulin) guided by OptiScanner®"
15970602|NCT03107793|Drug|Ustekinumab|Participants will receive IV induction treatment with ustekinumab on a weight-tiered basis at a dose of approximately 6 milligram per kilogram (mg/kg) IV. At Week 8, all participants will receive a 90 mg SC injection of ustekinumab. During the routine care maintenance treatment period, in case of clinical worsening reported by the participant, consistent with disease flare in the investigator's judgment, clinical assessments of disease flare will be performed at the investigator's discretion.
15970603|NCT03107780|Other|Laboratory Biomarker Analysis|Correlative studies
15970604|NCT03107780|Drug|MDM2 Inhibitor KRT-232|Given PO
15970605|NCT03107780|Other|Pharmacological Study|Correlative studies
15970606|NCT03107780|Radiation|Radiation Therapy|Undergo radiation therapy
15970607|NCT03107767|Procedure|PRO-malleol algorithm|An evidence based algorithm for ankle fractures
15970608|NCT03107754|Drug|Lidocaine|Paracervical block will be injected at 2 points at the cervicovaginal junction to decrease pain
15970609|NCT03107754|Drug|Lidocaine-Sodium Bicarbonate|Paracervical block will be injected at 2 points at the cervicovaginal junction to decrease pain
15970610|NCT03107741|Other|Conventional Exercise|Subjects in this group will receive three 1-hour conventional exercise training sections per week for 12 weeks
15970611|NCT03107741|Other|Tai Chi|Subjects in this group will receive three 1-hour tai chi training sections per week for 12 weeks
15970612|NCT03107728|Device|Advanced orthotic brace|Participants will use an advanced exoskeletal orthosis.
15970613|NCT03107728|Device|Conventional orthotic brace|Participants will use the standard of care orthosis
15970614|NCT03107715|Behavioral|Breastfeeding Champion|iPad-based behavioral intervention facilitated by researcher
15970615|NCT03107715|Behavioral|Positive Messaging|iPad based behavioral intervention facilitated by researcher
15970616|NCT03107702|Diagnostic Test|melatonin|the relationship between melatonin level and analgesia requirement.
15970617|NCT03107689|Other|administration of intravenous lipid emulsion|all patients receive intravenous lipid emulsion at the discretion of the treating provider. This registry prospectively collects detailed information on such patients
15970618|NCT03107676|Other|trunk extensors endurance training|endurance training
15970619|NCT03107663|Drug|⁸⁹Zr-Df-IAB22M2C Infusion|A single dose of 3.0 (±20%) mCi of ⁸⁹Zr-Df-IAB22M2C (with 0.2 mg, 0.5 mg, 1.0mg, 1.5 mg, 5.0 mg, or 10.0 mg of protein) will be administered intravenously over 5-10 minutes.
15970620|NCT03107650|Procedure|Transanal total mesorectal excision of rectal cancer|To perform a total mesorectal excision through a transanal approach
15970621|NCT03107611|Drug|Pimecrolimus Cream, 1%|
15970622|NCT03107611|Drug|Placebo Cream|
15970623|NCT03107611|Drug|Pimecrolimus Cream, 1%|
15970624|NCT03107598|Drug|colloid preload|coparaison between colloid and crystalloide loading in spinal anesthesia for cesarean section
15970625|NCT03107585|Procedure|bilateral cervical plexus block|with a linear probe and after disinfection vascular neck axis are identified at first. At the cricoid cartilage we conducted an apical scan to locate the carotid bifurcation.at this level is carried out a lateral translation to the visibility of the deep cervical space below the sternocleidomastoidien muscle then a needle 50 is introduced in plane. we proceed in inundation of cervical space
15970626|NCT03107559|Diagnostic Test|perfüsion index|Determination of the relationship between VAS values and PI in patients with normal delivery who undergo epidural analgesia
15970627|NCT03107546|Device|Hyalomatrix|We are comparing two techniques for covering the open area of the finger at the end of syndactyly release surgery. We would like to compare the current technique, a skin graft, with a new technique called Hyalomatrix.
15970628|NCT03107546|Other|Skin graft|We are comparing two techniques for covering the open area of the finger at the end of syndactyly release surgery. We would like to compare the current technique, a skin graft, with a new technique called Hyalomatrix.
15970629|NCT03107533|Other|Video recording of clinical visit|For patients and parents that are considering scoliosis surgery, a video recording of the encounter will be obtained during their routine clinical visit to discuss surgery/options.
15970632|NCT03107507|Drug|Levetiracetam|Given in a bolus dose first 50mg/kg as levetiracetam reaches a therapeutic serum level rapidly in 1.3 hours. Titration will not be attempted in our study to reach drug level rapidly and consequent rapid effective control of seizures. Maintenance dose is then given at a dose of 10 - 40mg/kg/day divided every 12 hours.
15970633|NCT03107507|Drug|Phenobarbital|Phenobarbital is given intravenously in the form of a loading dose of 15mg/kg that can be repeated after a 20 minute interval not to exceed 30mg/kg then a maintenance dose 2-4 mg/kg/day divided every 12 hours.
15970634|NCT03107494|Device|Gala Airway Treatment System|The Gala Airway Treatment system is a device-based, energy delivery system that delivers high frequency short duration energy to the airway epithelium and sub-mucosal tissue layers. The energy is delivered via a proprietary catheter through the bronchoscope. In this study, 2 treatment sessions will be delivered 1 month apart. The right lung is treated at the first treatment session and the left lung is treated at the second treatment session. A third bronchoscopy will be performed 3 months following the second treatment session where treatment is not delivered but a cryo-biopsy will be taken from the airway sites that have been treated during the two previous bronchoscopic treatment session to evaluate the effect of the treatment on the airways producing excessive mucous. Subjects will be required to submit to several tests during the study including two CT scans (lung), respiratory function tests, exercise testing.
15970635|NCT03107481|Drug|Acetaminophen|Acetaminophen 1g IV
15970636|NCT03107481|Drug|Hydromorphone|Hydromorphone 1mg IV
15970637|NCT03107468|Other|Mokhuri intensive treatment|Patients in this arm will be treated with acupuncture, Chuna and patient consultation during 5 weeks. For acupuncture therapy, disposable sterile needles will be placed on LI4, ST36, LV3, B22, B23, B24 and B25 of both sides of a patient for 15 minutes. For Chuna therapy, the patient lies on the Ergo Style™ FX-5820 Table in the prone position and back muscles will be relaxed by manual manipulation during flexion and extension movement of the table for 5 to 6 minutes. Patient consultation regarding the precautions for everyday life, the precautions for activity in bed, the precautions for walking, the precautions for particular movements and the exercises will be offered for 5 minutes.
15970638|NCT03107468|Other|Non-surgical conventional standard treatment|Patients in this arm will be treated with 10 sessions of non-surgical conventional standard treatment including conventional drug treatment and injection treatment under the consultation of neurosurgeons or doctors of anesthesiology or rehabilitation medicine during 5 weeks. For drug therapy, muscle relaxants, NSAIDs, gabapentin, pregabalin or tricyclic antidepressants will be prescribe. For epidural steroid injection, 3cc of epidurals will be injected at the affected lesion once or twice. For physical therapy, participants shall participate in conventional physical therapy with the aid of physical therapists, including heating pad, deep tissue heating device and transcutaneous electrical nerve stimulation (TENS) twice a week during the five weeks of participation.
15970639|NCT03107455|Device|MitraClip|MitraClip consists in two clip arms and opposing grippers, which can be opened and closed against each other in order to grasp and gain cooptation of MV leaflets at the origin of the regurgitant jet
15970640|NCT03107442|Behavioral|Aerobic exercise|12-weeks aerobic exercise intervention based on the physical activity guidelines from the American College of Sports Medicine (≥150 min/week of moderate to vigorous [40-85% of the individual's heart rate reserve] exercise). Participants will perform the exercise on treadmills at the hospital. The volume and intensity of the exercise will progressively increase throughout the 12 weeks.
15970641|NCT03107429|Drug|Acetazolamide|Acetazolamide tablets were placed in capsules to make them look similar to placebo.
15970642|NCT03107429|Drug|Placebo|Placebo was a sugar based placebo placed in a capsule.
15970643|NCT03107429|Other|Trendelenburg Position|Placed in Trendelenburg Position
15970644|NCT03107416|Procedure|Hepatic artery embolization (HAE)|The intervention being studied is HAE for the treatment of HCC in combination with Bumetanide. HAE is a standard of care procedure.
15970645|NCT03107416|Drug|Bumetanide|Intra-arterial (IA) injection of 0.01mg/kg of Bumetanide in the first cohort, 0.02 mg/kg in the second cohort and 0.04 mg/kg of IA Bumetanide in the final cohort patients during standard HAE until stasis is evident.
15970646|NCT03107403|Behavioral|web form|The scale assessing the bereavement process is the one reported in Teissier 2010
15970647|NCT03107390|Other|Evaluate the blood level of NTproBNP|Evaluate the blood level of NTproBNP in patients with MICI compared to a healthy control population.
15970648|NCT03107377|Drug|EVO100|5 g dose applied up to 1 hour prior to coitus
15970649|NCT03107377|Drug|Placebo|5 g dose applied up to 1 hour prior to coitus
15970650|NCT03107364|Other|Hospital stay|Collection of hospital lengths of stay and readmissions
15970651|NCT03107351|Device|Cardiac contractility assessments with Kino-cardiograph|Cardiac contractility will be assessed with Kino-cardiograph device. Echocardiography will also be used for the experimental arm
15970652|NCT03107351|Device|Cardiac assessment repeatability with Kino-cardiograph|Cardiac contractility will be assessed with Kino-cardiograph device only, at different times of the day to assess the repeatability of the measures.
15970653|NCT03107338|Drug|DEXKETOPROFEN TROMETAMOL|Patients who were administered a single dose of 25 mg of DKT 15 minutes before surgery
15970654|NCT03107338|Other|Placebo|Patients who were administered a single dose of 500 mg of Vitamin C 15 minutes before surgery
15970655|NCT03107325|Other|Modification in acquisition protocol|Participants will be asked to be imaged at an additional time point.
15970656|NCT03107325|Drug|F-18 Fluorodeoxyglucose|Participants will be asked to be imaged at an additional time point during an FDG PET study
15970657|NCT03107312|Procedure|Single blood sample collection|Collection of single blood sample of 10 ml volume by venepuncture
15970658|NCT03107299|Other|Communication methods to encourage adherence|Prospective randomized controlled study in intention to treat in open monocentric in 3 arms: all patients benefiting from the current management (medical consultation every 4 to 6 months in the department of rheumatology)
15970659|NCT03107286|Drug|Tc-99M-MAG3|Participants will be asked to be imaged at an additional time point during a nuclear medicine study using Tc-99m MAG3
15970660|NCT03107286|Other|Modification in acquisition protocol|Participants will be asked to be imaged at an additional time point.
15970661|NCT03107273|Other|Dynamic cultures of in vitro hematopoietic stem cells|Improvement of prognostic scores used in myelodysplastic syndromes by identifying by dynamic in vitro culture of hematopoietic stem cells dynamic factors, reflections of ineffective haematopoiesis
15970662|NCT03107260|Other|To evaluate the relationship between oxygen saturation and the incidence of postoperative cognitive dysfunction in emergency surgery in elderly patients|Evaluate the relationship between oxygen saturation and the incidence of postoperative cognitive dysfunction in non-cardiac, thoracic and vascular emergency surgery in patients 65 years of age and older. The occurrence of POCD will be defined by the MMSE decrease of at least 4 points at 24, 48 or 72 hours
15970663|NCT03107247|Drug|Tc-99M MDP|Participants will be asked to be imaged at an additional time point during a nuclear medicine study using Tc-99m MDP
15970664|NCT03107247|Other|Modification in acquisition protocol|Participants will be asked to be imaged at an additional time point.
15970665|NCT03107234|Other|Assess the level of expression of IP3R3 in cancerous tissues and healthy tissues|Assess the level of expression of IP3R3 in cancerous tissues and healthy tissues
15970666|NCT03107221|Behavioral|"Smart Eating internet-based self-help programme"|An internet-based self-help programme using cognitive behavioural therapy principles to treat individuals receiving input from a specialist eating disorders service. The programme takes 3 months to complete.
15970667|NCT03107208|Drug|Glargine|A dose of glargine (Lantus) will be given subcutaneously either early in the management of DKA (study group) or upon resolution of DKA (control group).
15970668|NCT03107208|Device|Continuous Glucose Monitor (Abbott FreeStyle Libre Pro)|All participants will be asked to wear a continuous glucose monitor (CGM) during the DKA and for a week following the DKA in order to better understand blood glucose control during DKA. This is an optional part of the study.
15970669|NCT03107195|Drug|Imaging Time|Participants will be asked to be imaged at an additional time point.
15970670|NCT03107182|Drug|nab-paclitaxel|All enrolled patients will receive three 21-day cycles of nab-paclitaxel (100 mg/m2 on days 1, 8, 15; 9 doses total)
15970671|NCT03107182|Drug|Carboplatin|All enrolled patients will receive three 21-day cycles of carboplatin (AUC 6 on day 1; 3 doses total).
15970672|NCT03107182|Drug|Nivolumab|"All enrolled patients will receive three 21-day cycles of nivolumab (360 mg on days 1; 3 doses total).
~Adjuvant nivolumab will be offered to all patients for 6-months post completion of locoregional therapy for a total of 7 doses."
15970673|NCT03107182|Drug|Cisplatin|Cisplatin will be given on an every 3 weeks basis at a dose of 100 mg/m2 IV over 3-4 hrs day 1 (or 2) and 22 (or 23). Only for patients on the Intermediate Dose Arm and additionally on day 43 (or 44) for patients on the Regular Dose Arm.
15970674|NCT03107182|Drug|Hydroxyurea|Patients on the Intermediate or Regular Dose Arms will receive chemoradiation for 3-5 cycles (6-10 weeks). On day 0 patients will start hydroxyurea at 500 mg PO q 12 hours x 6 days (11 doses). The first daily dose of hydroxyurea on days 1 - 5 is given 2 hours prior to the first fraction of daily radiotherapy.
15970675|NCT03107182|Drug|5-FU|Patients on the Intermediate or Regular Dose Arms will receive chemoradiation for 3-5 cycles (6-10 weeks). On day 0 at 1800 patients will start continuous infusion of 5-FU at 600 mg/m2/day x 5 days (120 hours).
15970676|NCT03107182|Drug|Dexamethasone|Patients on the Intermediate or Regular Dose Arms will receive chemoradiation for 3-5 cycles (6-10 weeks). On days 1-5 patients will receive dexamethasone 20 mg PO (IV) in am Day 1, 1 hr prior to paclitaxel
15970677|NCT03107182|Drug|Famotidine|Patients on the Intermediate or Regular Dose Arms will receive chemoradiation for 3-5 cycles (6-10 weeks). On days 1-5 patients will receive famotidine 20 mg PO (IV) in am Day 1, 1 hr prior to paclitaxel.
15970678|NCT03107182|Drug|Diphenhydramine|Patients on the Intermediate or Regular Dose Arms will receive chemoradiation for 3-5 cycles (6-10 weeks). On days 1-5 patients will receive diphenhydramine 50 mg PO (IV) in am Day 1, 30 mins prior to paclitaxel.
15970679|NCT03107182|Drug|Paclitaxel|Patients on the Intermediate or Regular Dose Arms will receive chemoradiation for 3-5 cycles (6-10 weeks). On days 1-5 patients will start paclitaxel 100 mg/m2 after first RT fraction on day 1 of each cycle. Paclitaxel should be administered in 250 ml 0.9% NaCl over 60 minutes.
15970680|NCT03107182|Procedure|Transoral robotic surgery (TORS)|Patients with low risk and small volume tonsillar disease (T1-T2, non-bulky N2A-N2B with ≤2 non-lower neck lymph nodes measuring ≤5 cm in size) or base of tongue disease (T1-2 with lateralized primary ≤3 cm, non-bulky N2A-N2B with ≤2 non-lower neck lymph nodes measuring ≤5 cm in size) who have ≥50% reduction by RECIST following induction chemotherapy will undergo TORS and selective nodal dissection. Patients may refuse TORS treatment. Patients will receive RT or TORS.
15970681|NCT03107182|Radiation|Adjuvant RT|Patients with low risk, who do not qualify for TORS (due to volume of disease or poor visualization/access) or refuse TORS, who have ≥50% reduction by RECIST following induction chemotherapy will be given de-intensified treatment with radiation alone to 50 Gy. Patients will receive RT or TORS.
15970682|NCT03107182|Radiation|Chemoradiotherapy|"Patients who have low risk disease with <50% but ≥30% reduction, or patients who have high risk disease and ≥50% reduction of tumor by RECIST with induction chemotherapy will receive CRT to 50 Gy with concurrent bolus cisplatin (x2 doses) or TFHX to 45 Gy (3 cycles).
~Patients who have low risk disease and <30% reduction of tumor, patients who have high risk disease and <50% reduction of tumor by RECIST, or any patient who has progressive disease with induction chemotherapy will receive CRT to 70 Gy with concurrent bolus cisplatin (x3 doses) or TFHX to 75 Gy (5 cycles)."
15970683|NCT03107169|Other|FMT|Patients in the FMT group received FMT-FURM
15970684|NCT03107169|Drug|Vancomycin|Patients in the vancomycin group received oral vancomycin (250 mg every 6 h for 10-14 days)
15970685|NCT03107156|Behavioral|Carevive CPS|This intervention will focus on the use of the Carevive CPS at the point of treatment decision making, enabling providers to deliver evidence-based and personalized treatment care plans to their NSCLC patients on active treatment. The Carevive CPS collects electronic patient reported outcomes (ePROS) and clinical data, reported and generated by clinical staff and/or extracted from the electronic medical record (EMR), and uses these to auto-generate the personalized care plans. Care plan content is drive by practice guidelines and other peer-reviewed evidence, and includes patient education, resources, and referrals developed by cancer clinicians and researchers.
15970686|NCT03107143|Device|Q2 System|
15970687|NCT03107117|Behavioral|Computer Counseling|two computer counseling online programs for a teen and a parent
15970688|NCT03107117|Behavioral|Standard Care|A referral for substance use counseling
15970689|NCT03107104|Device|Topcon DRI OCT Triton (plus)|The Topcon DRI OCT Triton (plus) is an OCT with a fundus camera used for diagnostic purposes
15970690|NCT03107104|Device|TRC-50DX retinal camera|The TRC-50DX retinal camera is a fundus camera used for diagnostic purposes
15970691|NCT03107091|Drug|Terlipressin acetate continuous infusion|Low-dose continuous infusion of Terlipressin administered via ambulatory pump over 28 days
15970692|NCT03107078|Drug|Glucocorticoids|Intravenous Glucocorticoids (GCs)
15970693|NCT03107065|Device|Thermi Radiofrequency|Percutaneous-Temperature Controlled-Radiofrequency Electrocoagulation
15970694|NCT03107052|Drug|Fremanezumab|Fremanezumab
15970695|NCT03107039|Behavioral|Exercise|A 12 week resistance exercise curriculum
15970696|NCT03107039|Behavioral|Health Education|A 12 week health education curriculum
15970697|NCT03107026|Drug|dasotraline 4mg|dasotraline 4mg tablet once daily
15970698|NCT03107026|Drug|dasotraline 6mg|dasotraline 6mg tablet once daily
15970699|NCT03107026|Drug|Placebo|Placebo tablet once daily
15970700|NCT03107013|Drug|[14C]-BTD-001|Carbon-14 labeled BTD-001
15970701|NCT03107000|Procedure|Trabeculectomy|Incisional surgery for glaucoma
15970702|NCT03107000|Procedure|Phako-trabeculectomy|Incisional surgery for glaucoma plus cataract
15970703|NCT03106987|Drug|Active Comparator: Olaparib tablets|"Olaparib
~300mg Olaparib tablets taken orally twice daily (except where this dose and formulation was previously not tolerated) until objective radiological disease progression as per RECIST 1.1 or as long as in the Investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria."
15970704|NCT03106987|Drug|Placebo|"Placebo
~300mg placebo tablets taken orally twice daily (except where this dose and formulation was previously not tolerated) until objective radiological disease progression as per RECIST 1.1 or as long as in the Investigator's opinion they are benefiting from treatment and they do not meet any other discontinuation criteria."
15970705|NCT03106974|Device|orotracheal intubation Macintosh Laryngoscope|orotracheal intubation (OTI) after induction of anesthesia and complete relaxation
15970706|NCT03106974|Device|orotracheal intubation Totaltrack VLM|orotracheal intubation (OTI) after induction of anesthesia and complete relaxation
15970707|NCT03106961|Device|Bioresorbable vascular scaffolds, OCT, non-compliant ballooning|Measure the effect of high-pressure, NC ballooning on scaffold embedding by OCT
15970708|NCT03106948|Drug|Placebo|Subject will undergo endoluminal biopsy prior to angioplasty but will NOT undergo insertion of the ACT drug delivery catheter
15970709|NCT03106948|Drug|Ascorbic Acid|Subject will undergo endoluminal biopsy prior to angioplasty followed by insertion of the ACT drug delivery catheter where ascorbic acid (10.0 µM) will be injected following conventional balloon angioplasty
15970710|NCT03106948|Drug|Cuprimine Oral Product|Subject will undergo endoluminal biopsy prior to angioplasty followed by insertion of the ACT drug delivery catheter where ascorbic acid (10.0 µM) in combination with D-penicillamine (25 µM) will be injected following conventional balloon angioplasty
15970711|NCT03106935|Drug|Levothyroxine|Levothyroxine is an orodispersible tablet.For the LT4 treatment group, 50μg LT4 (Merck Serono, Geneva,Switzerland) was administered every morning from the first day of diagnosed as subclinical hypothyroidism and continued up to the day of serum β-HCG measurement.If pregnancy was confirmed, levothyroxine dose need to increase 25-30% and adjusted according to the pregnancy specific reference range ( T1 0.1-2.5mIU/L,T2 0.2-3.0mIU/L, T3 0.3-3.0mIU/L) .
15970712|NCT03106922|Drug|PMF104|"Powder for oral solution:
~Sachet A: macrogol 4000 52.500 g, anhydrous sodium sulphate 3.750 g, simeticone 0.080 g;
~Sachet B: sodium citrate 1.863 g, anhydrous citric acid 0.813 g, sodium chloride 0.730 g, potassium chloride 0.370 g;
~One sachet A + 1 sachet B in 500 ml of water"
15970713|NCT03106922|Drug|Klean-prep|"Powder for oral solution:
~macrogol 3350 59.000 g, anhydrous sodium sulphate 5.685 g, sodium bicarbonate 1.685 g, sodium chloride 1.465 g, potassium chloride 0.7425 g.
~One sachet to be dissolved in 1 L of water"
15970714|NCT03106909|Radiation|pulmonary computed tomography (CT)|Pulmonary CT imaging
15970715|NCT03106883|Behavioral|Affective training|3 sessions of active training using affective faces to modify the negative attention bias in depression
15970716|NCT03106883|Behavioral|Sham training|3 sessions of sham attention training using non-affective stimuli
15970717|NCT03106870|Drug|Insulin Mixtard|"Insulin dose:
~0.7 IU/Kg (at the second trimester of pregnancy).
~0.8 IU/Kg (at the third trimester of pregnancy). Insulin dose was raised at a rate of 1 IU for every 10 mg/dl higher than the target blood glucose concentration."
15970718|NCT03106870|Drug|Metformin|"Oral metformin at a dose of 1500 mg divided into three doses, were taken with meals, in addition to insulin.
~If the target blood glucose concentrations were not attained, the dose of metformin was raised to 2000 mg per day."
15970719|NCT03106857|Other|Group A|Group A Physical activity and low caloric diet for
15970720|NCT03106844|Drug|Fecal Microbiota Transplantation|Patients with at least 2 episodes of CDI and IBD will undergo a single FMT
15970721|NCT03106831|Drug|Pituitrin infusion|To begin with 0.02 U/min to maintain mean arterial pressure(MAP) higher than 65 mmHg.
15970722|NCT03106831|Drug|Norepinephrine infusion|To begin with 0.04 μg/kg.min to maintain mean arterial pressure(MAP) higher than 65 mmHg.
15970723|NCT03106818|Drug|bupivacain with magnesium sulphate|will receive bupivacain 0.125% and magnesium sulphate 5% infusion in the presternum , for 48 hours
15970724|NCT03106818|Drug|Bupivacaine only|will receive bupivacain 0.125% infusion in the presternum , for 48 hours
15970725|NCT03106818|Drug|conventional|only conventional post operative analgesics will be used
15970729|NCT03106792|Dietary Supplement|Hairfinity #2|Variation to main formulation
15970730|NCT03106792|Dietary Supplement|Hairfinity #3|Variation to main formulation
15970731|NCT03106792|Dietary Supplement|Placebo|No active ingredients
15970734|NCT03106766|Drug|Acne cream 2X|Twice daily application of facial acne cream 2X after facial cleansing
15970735|NCT03106766|Drug|Acne cream 1X|Twice daily application of facial acne cream 1X after facial cleansing
15970736|NCT03106753|Drug|Bupivacaine|intrathecal bupivacaine 7.5 mg
15970737|NCT03106753|Drug|Terbutaline|0.25 mg Terbutaline subcutaneously
15970738|NCT03106740|Drug|Minocycline Hydrochloride 100mg Capsule|Minocycline 100mg will be administered by mouth daily for 2 weeks
15970739|NCT03106740|Diagnostic Test|Magnetic Resonance-Positron Emission Tomography Imaging|Up to 15 millicuries of [11C]PBR28 will be administered to each subject at each imaging visit, for a maximum of 2 imaging visits.
15970740|NCT03106740|Other|Placebo Capsule|1 Placebo Capsule (compounded with lactose powder) will be administered by mouth daily for 2 weeks
15970741|NCT03106727|Behavioral|Household model|The proposed intervention is a 'Household Model' where, instead of being assigned to HIV or TB patients, CHWs will rather be assigned to households and will be trained to provide support for a wider range of conditions including HIV, hypertension, diabetes and pediatric malnutrition. The new model is designed to improve retention in care for clients with chronic, non-communicable diseases, along with increased uptake of women's health services and treatment for pediatric malnutrition, while sustaining the high retention rates for clients in the HIV program.
15970742|NCT03106714|Diagnostic Test|RT-PCR|Persistence of detectable Zika virus (by RT-PCR test) in all selected body fluids
15970743|NCT03106701|Procedure|Ablation|Epicardial Radiofrequency ablation
15970744|NCT03106688|Diagnostic Test|fMRI imaging|Using blood oxygenation level dependent (BOLD) echo-planar imaging, fMRI will be used for characterising individual differences in the brain circuits.
15970745|NCT03106688|Diagnostic Test|[11C]carfentanil PET scan|[11C]carfentanil is used to measure μ-opioid receptor (MOR) availability in brain.
15970746|NCT03106688|Diagnostic Test|[18F]FMPEP-d2 PET scan|[18F]FMPEP-d2 is used to measure cannabinoid receptor type 1 (CB1) availability in brain and body.
15970747|NCT03106688|Diagnostic Test|[18F]-FDG PET scan|Brain and body insuin stimulated glucose uptake is measured with radioligand [18F]-FDG.
15970748|NCT03106688|Diagnostic Test|Physical activity measures and fitness tests|Physical activity will be measured over one week following the screening check-up, before the PET measurement days. For the measurement, subjects will wear Polar M600 GPS Sports Watch for the measurement period. The fitness tests will be performed at the Paavo Nurmi Centre.
15970749|NCT03106688|Diagnostic Test|Laboratory measurements|Weight, height, blood pressure, medical history, and current medication are determined. Body fat percentage will be assessed using BodPod plethysmograph.
15970750|NCT03106688|Diagnostic Test|Questionnaires|All the participants will complete a self-administered questionnaire at baseline, and at 12 months, for assessment of leisure-time physical activity (LTPA). The following questionnaires will be completed: Behavioural inhibition / activation, Dutch Eating Behaviour Questionnaire, Yale Food Addiction Scale, PCL-Revised, Food craving State / Trait (FCS-FCST) questionnaires, Autism Spectrum Quotient, State-Trait Anxiety Questionnaire and Pain Sensitivity Questionnaire.
15970751|NCT03106688|Diagnostic Test|Hyperinsulinemic euglycemic clamp|Low-dose hyperinsulinemic euglycemic clamp technique will be used to promote glucose uptake and measure insulin sensitivity of the subjects. In the clamp study subjects are administered intravenous insulin at a steady rate of 0.25 mU/kg/min and normoglycemia is maintained using a variable rate infusion of 20 % glucose based on plasma glucose measurements, which are performed every 5-10 min from arterialized venous blood.
15970752|NCT03106675|Device|Thermal ablation of bone metastasis with MR-HIFU device Philips Sonalleve coupled with Philips Ingenia 3.0T|"Procedure is performed under proper analgesia (general or local anesthesia). The intervention can be performed in areas accessible with ultrasound with no critical structures (nerves, vasculature, bowels) in proximity. Limbs and pelvis are most usually accepted locations.
~Patient is adjusted on top of the HIFU-transducer connected to MRI. First a MR-scan is performed and the treatment procedure is planned on consol. Then under MRI-guidance a point by point ablation of the target tumor is performed. During the treatment a real-time thermometry is obtained in order to avoid unwanted heating of related structures and to observe sufficient effect on treatment zone. After treatment MR-scan with gadolinium is performed to evaluate the size of ablated area."
15970753|NCT03106675|Device|Varian Truebeam Radiotherapy System|Conventional radiotherapy focused on bone tumor. Pretreatment planning images acquired with computer tomography
15970754|NCT03106662|Biological|mesenchymal stem cells|After preferred conditioning regimen for the patient, cyclophosphamide 50 mg/kg/day will be administered at +3 and +4 post transplant day. At +6 post transplant day, 2-8x10^8 cell/kg mesenchymal stem cells will be infused.
15970755|NCT03106662|Drug|cyclophosphamide administration|After preferred conditioning regimen for the patient, cyclophosphamide 50 mg/kg/day will be administered at +3 and +4 post transplant day.
15970756|NCT03106649|Device|Echocardiography|Before administration of spinal anesthesia, Echocardiography will be performed to determine the LVEDA. If the LVEDA is more than 10 square cms, the patient will be considered as volume replete and spinal anesthesia will be administered. If the LVEDA is less than 10 square cms, a fluid bolus of 250 ml of a balanced salt solution will be given and LVEDA reassessed. This will be repeated till the LVEDA is more than 10 square cms or fluid bolus has been given twice and still the LVEDA is less than 10 square centimeters, in which case phenylephrine 1-2µg/kg will be given before administering spinal anesthesia.
15970757|NCT03106649|Device|Treatment of spinal hypotension|For treatment of spinal hypotension, in the event of hypotension(defined as a mean arterial pressure less than 60 mm Hg or decrease in mean arterial pressure of more than 20% from the baseline value) after spinal anesthesia, the LVEDA will be assessed. If more than 10 square centimeters, the patient will be considered volume replete and a vasopressor in the form of phenylephrine 1-2µg/kg will be given. If the LVEDA is less than 10 square centimeters, a volume bolus of 250ml will be given. On reassessment if the LVEDA is still less than 10 square centimeters the volume bolus can be repeated. In the event of hypotension persisting in spite of volume resuscitation, phenylephrine 1-2µg/kg will be given.
15970758|NCT03106636|Behavioral|KEEP-P|The KEEP-P program is a low-cost, manualized, group-based intervention for caregivers of preschool aged children. This trial is evaluating 2 versions of the intervention. KEEP-P is a basic version that employs a curriculum of 12 weekly psychoeducational caregiver support groups Across four waves of data collection (baseline, post-intervention, and 12 and 18 months post-baseline), we will examine the extent to which this intervention condition shows improved parenting, reduced rates of disrupted placements, and improved child outcomes.
15970759|NCT03106636|Behavioral|KEEP-P+|The KEEP-P program is a low-cost, manualized, group-based intervention for caregivers of preschool aged children. This trial is evaluating 2 versions of the intervention. KEEP-P+ is an augmented version that consists of the caregiver support groups with extended curriculum including information about recent findings in early brain development and the elements of the Filming Interactions to Nurture Development video coaching program. Across four waves of data collection (baseline, post-intervention, and 12 and 18 months post-baseline), we will examine the extent to which this intervention condition show improved parenting, reduced rates of disrupted placements, and improved child outcomes.
15970760|NCT03106623|Drug|ONO-8577|Oral administration of ONO-8577 once a daily for 4 weeks
15970761|NCT03106623|Drug|solifenacin succinate + mirabegron|Oral administration of solifenacin succinate and mirabegron once a daily for 4 weeks
15970762|NCT03106623|Drug|Placebo|Oral administration of Placebo once a daily for 4 weeks
15970763|NCT03106610|Drug|Nivolumab|3 mg/kg of body weight by vein over about 60 minutes on Day 1 of Cycles 1-3.
15970764|NCT03106610|Behavioral|Questionnaires|2 quality-of-life questionnaires completed on Day 1 of Cycles 1-3, at the visit before surgery, and 4 weeks after surgery.
15970765|NCT03106597|Drug|Manidipine 20mg|"After a 1~2-week run-in period, patents will be randomized to receive manidipine (20 mg/day; n=50) for a 8-week open-labeled phase. Study drugs will be administered orally and once daily between 8:00am and 10:00am.
~BP, heart rate, adverse events and concomitant therapy are assessed and a physical examination is performed at each visit. A 12-lead standard ECG is obtained and hematology, clinical biochemistry and urine analysis investigations performed at the screening visit. A Bioelectrical Impedance Analysis (BIA) is undertaken at the screening visit and at the end of the 8-week treatment course. Patients have to attend the clinic visit every 4 weeks during the treatment period."
15970766|NCT03106597|Drug|Amlodipine 10mg|"After a 1~2-week run-in period, patents will be randomized to receive amlodipine (10 mg/day; n=50) for a 8-week open-labeled phase. Study drugs will be administered orally and once daily between 8:00am and 10:00am.
~BP, heart rate, adverse events and concomitant therapy are assessed and a physical examination is performed at each visit. A 12-lead standard ECG is obtained and hematology, clinical biochemistry and urine analysis investigations performed at the screening visit. A Bioelectrical Impedance Analysis (BIA) is undertaken at the screening visit and at the end of the 8-week treatment course. Patients have to attend the clinic visit every 4 weeks during the treatment period."
15970767|NCT03106584|Dietary Supplement|Aquamin-Plus|"Aquamin (a calcium-rich marine multi-mineral) - 666.7mg magnesium hydroxide - 66.66mg pine bark - 30mg vitamin d3 - 2.5μg
~Dosage:
~4 Capsules is equal to effective dose"
15970768|NCT03106584|Dietary Supplement|Glucosamine sulphate|"The Glucosamine sulphate supplement contains 500mg of the active ingredient Glucosamine sulphate per serving (one capsule).
~Dosage:
~4 Capsules is equal to effective dose"
15970769|NCT03106571|Drug|Pomaglumetad methionil|Tablets twice daily
15970770|NCT03106571|Drug|Placebo|1-4 tablets twice daily
15970771|NCT03106571|Drug|Methamphetamine|intravenous methamphetamine
15970772|NCT03106558|Device|Total Knee Arthroplasty using Manual Instrumentation|
15970773|NCT03106558|Device|Total Knee Arthroplasty using Robotic Arm|
15970774|NCT03106545|Drug|Liposome bupivacaine|
15970775|NCT03106532|Drug|PHP-201 0.25% ophthalmic solution|3 drops daily, 28 days
15970776|NCT03106532|Drug|PHP-201 0.5% ophthalmic solution|3 drops daily, 28 days
15970777|NCT03106532|Drug|Placebo ophthalmic solution|3 drops daily, 28 days
15970778|NCT03106519|Drug|Liposome bupivacaine + bupivacaine|
15970779|NCT03106506|Procedure|Connective tissue graft|Implant installation surgery with cone morse system with the concomitant placement of autogenous connective tissue.
15970780|NCT03106493|Other|None (observational)|None (observational)
15970781|NCT03106467|Procedure|Single-port laparoscopic appendectomy|Single-port laparoscopic appendectomy: A 1.5 cm skin incision is made inside the umbilicus and single port is introduced through it. The appendix is manipulated by a combination of a 5-mm scope, angulated, and straight instruments. The periappendiceal vessels and appendix are ligated and divided. Specimen is delivered via the transumbilical port. Umbilical fascia and skin are routinely closed.
15970782|NCT03106467|Procedure|Three-port laparoscopic appendectomy|Three-port laparoscopic appendectomy: CLA requires the introduction of a 30-degree 5-mm or 10-mm rigid scope through a 0.5 - 1.0 cm intra umbilical incision. Two additional 5-mm incisions are made outside umbilicus. Appendectomy is performed in the same manner as described for the SLA above. The umbilical fascia and skin are routinely closed.
15970783|NCT03106454|Drug|Ethinyl Estradiol, Norethindrone acetate, ferrous fumarate|Combination Oral Contraceptive Pill. Ethinyl Estradiol 10mcg/Norethindrone acetate 1mg/ferrous fumarate 75mg
15970784|NCT03106454|Drug|Norethindrone|Norethindrone 1.05mg
15970785|NCT03106441|Device|High flow oxygen therapy by nasal cannula. Optiflow®|Patients randomized in interventional group will received a four minutes preoxygenation period with High Flow nasal cannula (60 l/mn FiO2 = 1) before orotracheal intubation. The device will be maintained in place throughout the intubation procedure in order to achieve apnoeic oxygenation.
15970786|NCT03106441|Device|Facial mask oxygenation in BIPAP ventilation|Patients randomized in BIPAP group will receive a four minutes preoxygenation with EPAP 5, IPAP 15 FiO2 = 1 for a pressure support of 10 cm H2O. The facial mask with be removed after before crash induction enabling laryngoscopic vision
15970787|NCT03106428|Drug|MEDI7247|The study will enroll patients with R/R AML/MM/DLBCL who will receive MEDI7247 IV
15970788|NCT03106415|Drug|Binimetinib|Given PO
15970789|NCT03106415|Other|Laboratory Biomarker Analysis|Correlative studies
15970790|NCT03106415|Biological|Pembrolizumab|Given IV
15970791|NCT03106402|Drug|topical bromfenac sodium hydrate|
15970792|NCT03106389|Drug|Misoprostol|400 micro grams misoprostol administered vaginally followed every 6 hours by 400 micro grams orally until complete expulsion
15970793|NCT03106389|Device|Misoprostol/Transcervical catheter|Foleys' catheter introduced into the cervix and inflated with 30 ml. of fluid; weighted traction applied by using a 1000 ml fluid-filled bag
15970794|NCT03106376|Other|16% O2 gas in breathed air|"Inspiratory gas mixtures: Hypoxic inspiratory gas will be obtained by adding nitrogen (N2) to normobaric, normoxic air with medical N2 tanks.
~Delivery of gas mixture: The gas mixture will be delivered by standard tight facemask."
15970795|NCT03106376|Other|26% O2 gas in breathed air|"Inspiratory gas mixtures: Hyperoxic inspiratory gas will be obtained by adding oxygen (O2) to normobaric, normoxic air with medical O2 tanks.
~Delivery of gas mixture: The gas mixture will be delivered by standard tight facemask."
15970796|NCT03106363|Drug|delta 9 tetrahydrocannabinol|A single cannabis cigarette (potency 12.5% delta 9 tetrahydrocannabinol) will be given to participants to smoke over a 10 minute period, ad libitum. If the cannabis cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose.
15970797|NCT03106363|Drug|placebo delta 9 tetrahydrocannabinol|A single placebo cannabis cigarette (<0.03% delta 9 tetrahydrocannabinol) will be given to participants to smoke over a 10 minute period, ad libitum. If the placebo cannabis cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose (as this is a double-blind study).
15970798|NCT03106363|Drug|Alcohol|A single oral administration of an alcoholic beverage mixed in a 1:3 ratio of alcohol to tonic water to obtain a target blood alcohol content of 0.08mg%.
15970799|NCT03106363|Drug|Placebo alcohol|A single oral administration of a beverage containing tonic water of the same volume as the alcoholic beverage.
15970800|NCT03106350|Other|Questionnaire|The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. It is a copyrighted instrument, which has been translated and validated in over 100 languages and is used in more than 3,000 studies worldwide.
15970801|NCT03106337|Device|Shear-Wave Elastography|Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision.
15970802|NCT03106324|Drug|Revlimid (lenalidomide)|Treatment with first line Revlimid containing regimen as prescribed in routine clinical practice
15970803|NCT03106311|Diagnostic Test|assessment of beta subunit of human chorionic gonadotropin|Vaginal washing fluid will be collected and sent for measurement of beta subunit of human chorionic gonadotropin
15970804|NCT03106298|Drug|Iron Sucrose|All participants will be given intravenous iron sucrose (200 mg) weekly for 5 weeks. Iron sucrose is infused over 60 minutes.
15970805|NCT03106285|Dietary Supplement|Lactobacillus reuteri DSM17938|5 drops of active oil drops. The active dose consists of 10^8 CFU L retueri DSM17938
15970806|NCT03106285|Dietary Supplement|Placebo|5 drops of placebo drops
15970807|NCT03106259|Drug|FURESTEM-RA Inj.|Non-interventional observational study
15970808|NCT03106233|Procedure|LTP flap|A flap is harvested from the upper lateral thigh region based on septocutaneous perforators located in the posterior septum between the tensor fascia latae and gluteus medius muscles.
15970809|NCT03106220|Behavioral|exercise|home exercise program
15970810|NCT03106220|Other|placebo|encourage walking and physical therapy per standard care.
15970811|NCT03106207|Procedure|Upper gastric endoscopy (UGE)|UGE will be performed before the gastric bypass surgery and post-surgery at two, six and 12 months of clinical visit.
15970812|NCT03106194|Other|case management|
15970813|NCT03106181|Device|iStent inject®|Insertion of iStent inject®
15970814|NCT03106181|Procedure|Phacoemulsification and intraocular lens implant|Conventional phacoemulsification cataract surgery and intraocular lens implant
15970815|NCT03106168|Procedure|Extraction of mandibular molar|Patients who require extraction of mandibular molars will be submitted to surgery
15970816|NCT03106155|Drug|vistusertib (AZD2014)|vistusertib(AZD2014): 50 mg BID per os every 12 hours administration daily. One cycle is consisted of 3 weeks.
15970817|NCT03106142|Procedure|Academic detailing visit arm|General Practitioners in the intervention group will receive one academic detailing visit. During this visit the GPs will receive information about the importance of physical therapy in the non-surgical management of knee osteoarthritis. The information will be summarized on an information leaflet for the GP.
15970818|NCT03106116|Device|Experimental: Enhanced External Counterpulsation|Enhanced External Counterpulsation (EECP) is a technique for assisting the circulation by decreasing the afterload of the left ventricle and augmenting the diastolic pressure externally by applying a negative pressure to the lower extremities during cardiac systole. EECP therapy has been approved by the United States Food and Drug Administration (FDA) for the treatment of refractory angina and heart failure. Administration of 35-36 hours EECP therapy over a 7 week period, one hour session every working day.
15970819|NCT03106116|Drug|Standard medical therapy|Guideline- driven standard medical treatment for 7 weeks
15970820|NCT03106090|Other|educational materials|The eSCP includes a treatment summary section, a section detailing follow-up and test recommendations, a section on anticipated and potential side effects, as well as additional information specific to their experience/concerns. They will receive a patient education notebook outlining symptoms and their management that is tailored to those that the subject may be likely to experience during their survivorship care trajectory.
15970821|NCT03106077|Biological|Mirvetuximab Soravtansine|Given IV
15970822|NCT03106064|Behavioral|Promoting independence in self-care|The intervention will consist of an twice daily walking training, plus privileging trips to the toilet by walking (with support devices or with support from people) and all daytime meals seated (not in bed). Attending of the particular and unexplored characteristics of the proposed intervention, namely the use of the toilet and meals, the proposed intervention extends throughout the 24 hours of the day, seven days a week.
15970823|NCT03106064|Other|Usual Care|Usual hospital care
15970824|NCT03106038|Drug|Nerindocianine for Injection|Procedure: routine minimally invasive pelvic surgery.
15970825|NCT03106025|Device|Ultrasound|Each participant will receive an ocular ultrasound which poses minimal to no harm to the participant and the ultrasound results compared to final diagnosis.
15970826|NCT03106012|Procedure|Hysteroscopy|rigid continuous flow diagnostic hysteroscopy (Tuttligen, Karl Storz, Germany). It has a 30o panoramic optic which is 4mm in diameter and the diagnostic continuous flow outer sheath is 6.5 mm in diameter.
15971002|NCT03104634|Drug|Aclidinium bromide/formoterol fumarate dihydrate|Cross-over design with washout interval. Randomized order of active and placebo arm
15970827|NCT03106012|Procedure|Laparoscopy|Veress needle was placed through the umbilicus and into the peritoneal cavity,After a pneumo-peritoneum has been achieved with a Veress needle, the primary trocar with sleeve (5mm in diameter) was placed at a similar angle in to the Veress needle
15970828|NCT03105986|Drug|JNJ-64041575|Two 500-mg tablets administered as a single oral dose under fasted conditions on Day 1 or Day 22.
15970829|NCT03105986|Drug|Probenecid|One 500-mg tablet administered as a single oral dose with a total of 30 doses (2 doses on Day -1/21 starting in the evening followed by 4 doses per day on the rest of the days).
15970830|NCT03105973|Behavioral|Technology-Enabled CBT Treatment|CBT-based modules delivered via tablet over 4 weeks.
15970831|NCT03105960|Drug|garlic with lime mouth wash|garlic with lime juice is herbal antimicrobial 10 ml (undiluted) for 30s and then expectorate for 14 days.o prepare garlic with lime mouth rinse, 100 g of fresh, washed garlic cloves was macerated in a sterile, ceramic mortar and water was added to obtain a homogenate which was then filtered off with a sterile muslin cloth. the final concentration of the solution was determined to be 1 g/100 ml. About 100 ml of lime juice was extracted from fresh lemons using a juice extractor and added to the garlic extract.
15970832|NCT03105960|Drug|chlorhexidine|hlorhexidine is antimicrobial, antiplaque mouthwash 10 ml (undiluted) for 30 second twice daily and then expectorate for 14 days.
15970833|NCT03105947|Other|Coconut oil|50g extravirgin coconut oil daily for four weeks
15970834|NCT03105947|Other|Butter|50g butter daily for four weeks
15970835|NCT03105947|Other|Olive oil|50g extra virgin olive oil daily for four weeks
15970836|NCT03105934|Procedure|Patients with Pulmonary Arterial Hypertension|2 repeated measurement session to enable assessment of technical and medium-term reproducibility of IV-US and IV-OCT.
15970837|NCT03105921|Device|NanoKnife|The aim of the treatment is to sourround the tumour with two to six needles and to deliver a very high voltage current (3000 volts in 70 to 80 microseconds pulses) by a generator synchronized with an electrocardiogram.
15970838|NCT03105908|Behavioral|Internet delivered Acceptance and Commitment therapy|The main component in the treatment is exposure to symptoms and feared situations. The iACT program is adapted from the evidence based face-to-face treatment at the Behavioral Medicine unit at Karolinska University Hospital. The iACT program has a different structure but is equal in content to face-to-face treatment, and is to be completed within ten weeks. Participants receive texts, audio files, movies and exercises and have online contact with their psychologist via an internet platform or a smart phone application. The treatment aims to encourage valued behaviors in the presence of inner discomfort.
15970839|NCT03105908|Behavioral|Waiting list control condition|After a ten week wait list period, the control condition receive same treatment as the intervention group, but without therapist support.
15970840|NCT03105895|Procedure|Mesh group|An onlay PDVF mesh will be placed as abdominal wall reinforcement
15970841|NCT03105882|Device|Neuro-Spinal Scaffold|Experimental: Neuro-Spinal Scaffold
15970842|NCT03105869|Diagnostic Test|fluorocholine PET/CT|standard diagnostic PET/CT procedure
15970843|NCT03105856|Biological|CERVARIX|- HPV16/18 L1 VLP AS04 vaccine (Cervarix®) group according to a two-dose schedule (0-12 month). This group will receive the HPV16/18 vaccine containing HPV16 and HPV18 L1 virus-like-particles (20 μg of each) adjuvanted with 50 μg 3-O-desacyl-4'-monophosphoryl lipid A and 0.5 mg aluminum hydroxide (GlaxoSmithKline Biologicals, Rixensart, Belgium). A 0.5-mL dose of the vaccine will be administered in the non-dominant arm.
15970844|NCT03105856|Biological|GARDASIL|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) (Gardasil®) recombinant vaccine according to a two dose schedule (0-12 month). This group will receive amorphous aluminum hydroxyphosphate sulfate adjuvanted quadrivalent HPV (types 6, 11, 16, 18) L1 VLP vaccine (Merck Sharp & Dohme Corp. Whitehouse Station, NJ, USA). A 0.5-mL dose of the vaccine will be administered in the non-dominant arm.
15970845|NCT03105843|Drug|Methacholine (MCh) Challenge Testing|Visit 1: Informed consent, Baseline screening and pulmonary function tests and Low-dose methacholine challenge testing using partial and full flow-volume loops.
15970846|NCT03105843|Diagnostic Test|Eucapneic Voluntary Hyperventilation (EVH) and Hypertonic Saline (HS) Challenge Tests|Visit 2 or 3: Will be conducted in random order and subjects will perform one of the two challenge tests at either visit.
15970847|NCT03105830|Drug|iv paracetamol|iv paracetamol
15970848|NCT03105817|Device|Asymmetric cellulose triacetate (ATA™)|Each patient underwent 12 sessions of haemodialysis with the usual schedule, changing the usual dialyzer
15970849|NCT03105804|Other|FT21039|An electronic cigarette
15970850|NCT03105804|Other|FT21041|An electronic cigarette
15970851|NCT03105804|Other|FT21044|An electronic cigarette
15970852|NCT03105804|Other|FT21042|An electronic cigarette
15970853|NCT03105791|Other|Formal education regarding opioid usage|Participannts watched a 2 minute video and were given educational materials
15970854|NCT03105778|Diagnostic Test|standard blood draw as part of routine and fingerprick for capillary sample|All blood sample collection methods are standard routine procedures. These patients usually have an indwelling cannula from which blood samples are drawn. So no additional venipuncture is performed according to this study. The finger prick sample - taken only for study purposes - might be accompanied by small pain at the fingertip. But this pain is usually of short duration and tolerated very well. No unanticipated adverse events are expected to occur in this study.
15970855|NCT03105765|Drug|Placebo|Normal saline applied by bolus before operation started, followed by a continuous application of normal saline for 24 hours.
15970856|NCT03105765|Drug|Ketamine|Application of Ketamine 0,2mg/kg ideal Body weight by Bolus before the Operation started, followed by application of 0,2 mg/kg ideal Body weight for 24 hours.
15970857|NCT03105752|Other|Questionnaire of understanding|"The study involved 12 clinical trials conducted in the Clinical Research Center Paris Est. Twenty participants per trial were offered to answer the Qualité de Compréhension des Formulaires d'information et de consentement questionnaire (QCFic) at the inclusion visit after receiving the information by the investigator and signed or refused to sign the form of consent.
~Participants filled out the questionnaire in an isolated location, with no possibility of re-reading the information contained in the consent form. The questionnaire was immediately retrieved."
15970858|NCT03105739|Other|LMA removal|According to randomization, LMA device was removed at the end of surgery, either in deeply anesthetised patients or after consciousness recovery.
15970859|NCT03105713|Other|Patient Safety Checklist|The intervention is to be developed and implemented over three stages: 1) develop patient safety checklists for patients to use, 2) pilot testing of the checklists in 5 surgical clusters in two hospitals 3) a stepped wedge cluster randomized controlled trial of the patient safety checklists for patients to use.
15970860|NCT03105700|Device|Transcranial Magnetic Stimulation|Repetitive transcranial magnetic stimulation (TMS) is a focal, nonpharmacological, noninvasive method for stimulating the brain and modulating neural network activity. To administer TMS, an electromagnetic coil is placed on the scalp, and uses electrical current to create magnetic fields that depolarize or hyperpolarize neurons in the brain.
15970861|NCT03105687|Behavioral|SMS reminders of medicines intake|The intervention consists of daily SMS reminders of blood pressure-lowering medication provided by a pharmacist for a period of 3 months.
15970862|NCT03105674|Drug|Multi-drug local anesthetics (Combination)|"Ropivacaine 0.5% - 30 ml
~Ketorolac 30mg/ml - 1 ml
~Kenalog 10 mg/ml - 5 ml
~Lidocaine 1% with Epinephrine 1:100,000 - 20ml"
15970863|NCT03105674|Drug|Standard local anesthetics (Combination)|Marcaine and Lidocaine
15970864|NCT03105661|Drug|Labetalol Hydrochloride 200 mg|Anti-hypertensive prescribed for increased cardiac output as determined by Impedance Cardiography
15970865|NCT03105661|Drug|NIFEdipine 60 mg|Anti-hypertensive medication prescribed for increased systemic vascular resistance as determined by Impedance Cardiography
15970866|NCT03105661|Drug|Atenolol 25 mg|Anti-hypertensive prescribed for increased cardiac output with tachycardia or maternal pulse rate 110 or greater
15970867|NCT03105648|Other|computerized cytomorphometry|use computer program to analyse the characteristics of thyroid cells obtained by fine needle aspiration cytology examination
15970868|NCT03105635|Other|Mixed method feasibility study|"Participating practices will receive the following:
~Training on community resources : An orientation regarding the availability of the local community health and social resources, and the existing navigation services that can support individuals identify the appropriate resource.
~Facilitation to enhance referrals: help support practices to make the desired adaptations to enhance referrals
~Promotional material to engagement patients: Practices will provide an area in the waiting room where promotional material on the benefit and availability of community resources will be displayed.
~Navigator: The services of a Navigator"
15970869|NCT03105622|Behavioral|TV and music|Watching TV or listening to music while running on a treadmill
15970870|NCT03105609|Device|Hyperspectral imaging|Hyperspectral retinal images will be taken at baseline (before treatment with Lucentis) and then at 3 and 9 months after treatment.
15970871|NCT03105596|Drug|Chidamide plus DICE Regimen|Chidamide 20mg orally d1, 4, 8, 11, 15, 18; Dexamethasone 10mg，ivg, d1-4; ifosfamide 1g/m2, ivg, d1-4, given over 4 hours; Mesna 0.4g, 0,4,8,12 hours during Ifosfamide transfusion, ivg, d1-4; Cisplatin 25mg/m2, ivg, d1-4; Etoposide 60mg/m2, ivg. d1-4.
15970872|NCT03105583|Drug|Medication use during pregnancy|
15970873|NCT03105583|Dietary Supplement|Supplement use during pregnancy|
15970874|NCT03105583|Other|Vitamin status of a pregnant woman|Haemoglobin, RBC count + hematocrits, thrombocytes count, folate (serum), vitamin B12, WBC count, ferritin, iron (serum), transferrin % and saturation, TSH, T4, free glucose, LDH, ALT, AST, GGT, bilirubin (total), CRP, albumin, total protein, ureum, uric acid, creating, calcium (total), 25-hydroxy vitamin D, Na, K, Mg
15970875|NCT03105570|Procedure|Areola Sparing Mastectomy|A small circular incision would be made to separate nipple from breast and an additional incision directly extended from nipple or located at other part of breast such as infra-mammary fold and subaxillary area would be made to remove the total mammary parenchyma. Routine implant based or flap base reconstruction would be performed subsequentially. Nipple reconstruction is optional.
15970876|NCT03105557|Device|Urinary collecting device|Urinary collecting device
15970877|NCT03105544|Other|simulation-based training|As described under group descriptions
15970878|NCT03105518|Drug|Fentanyl|0.5, 1 mcg/kg
15970879|NCT03105518|Drug|Acetaminophen|Single + Oxycodone
15970880|NCT03105518|Drug|Oxycodone|With Acetaminophen
15970881|NCT03105505|Drug|Permethrin 5%|Facial skin application once a night for 3 months.
15970882|NCT03105505|Drug|Synthomycine 5%|Eye ointment, eyelids and eyelashes application (chloramphenicol), once a night for 3 months.
15970883|NCT03105505|Drug|Fusidic Acid 1% M/R Eye Drops|viscous eye drops application once a night for 3 months.
15970884|NCT03105479|Drug|Cadazolid|Granules for oral suspension to be administered twice daily
15970885|NCT03105479|Drug|Vancomycin capsule|Capsule containing 125 mg of vancomycin to be administered orally 4 times a day
15970886|NCT03105479|Drug|Vancomycin solution|Vancomycin powder to be administered as oral solution at a dose of 40 mg/kg/day, 3 to 4 times a day
15970887|NCT03105466|Procedure|Deep anterior lamellar keratoplasty|Deep anterior lamellar keratoplasty using acellular porcine cornea; 0.05%Tacrolimus eye drops, four times a day for at least one year; 0.3% Tobradex eyedrops, four times-one times a day for one year.
15970888|NCT03105466|Device|Acellular Porcine Cornea|
15970889|NCT03105466|Drug|Tacrolimus eye drops|
15970890|NCT03105466|Drug|Tobradex eyedrops|
15970891|NCT03105453|Other|3 Sampling points|When entering the in-vitro fertilization/intracytoplasmatic sperm injection 4 samples will be harvested: a rectal swab, a cervical swab, a vaginal swab and an intra-uterine sample using an empty embryo catheter. After the ovarian stimulation treatment, the same patients will be sampled two more times: once at the moment of oocyte retrieval (rectal, cervical, vaginal and intra-uterine samples) and again just before the embryo transfer (at this stage, the embryo culture medium will be harvested, as well as an intra-uterine sample using the tip of an empty embryo inner catheter before the embryo transfer and a rectal sample)
15970892|NCT03105440|Other|Virtual reality|"This virtual reality of projection software, which uses Kinact®, captures the patient's picture and transfers to the monitor. The exercises provided by game are similar to those performed in conventional therapy; however, in a more entertaining form.
~Comprised 8 exercises to upper limbs and trunk. The patient should reach the red circle until it becomes green."
15970893|NCT03105440|Other|Vibration therapy|"The vibration mat used in this study was developed by the members of the Laboratory of Sensory and Motor Engineering Rehabilitation together with mark Vibra Ind. e Com. Prod. Electronics Ltda.
~Will participate 20 woman, that stay in supine position, with the enveloped member of the vibration mat, elevated and supported. The volunteer will be submitted to 15 minutes of vibration with frequency of the 40 hertz, in both upper limbs."
15970894|NCT03105440|Other|Hand cycling|Will participate 20 woman, submitted hand cycling through of the adapted bicycle to upper members. The protocol will be comprised by track without obstacle, comprised by 10 turns. The cyclic movement velocity will be realized according to the physical fatigue of patients.
15970895|NCT03105440|Other|Canoeing|Will participate 20 woman, submitted canoeing activates, through rowing realized in therapeutic pool, with the aid and supervision of the therapeutic. It is important highlight that the exercises intensity will be to realized according to the physical fatigue of patients.
15970896|NCT03105440|Other|Robotic rehabilitation|It Will be used a exoskeleton Armeo®Spring, to training to affected upper limb, the protocol of the treatment is constituted for 8 games. The equipment arm will be adjusted the volunteers height, in sitting position, allowing support against the action of gravity of the arm and forearm, supporting 45° of the shoulder flexion, which will be facilitation the member movement.
15970897|NCT03105440|Other|Control group|Will participate 20 healthy woman, that won't pass to the treatment physiotherapeutic, only will be collected the electromyography and dynamometer.
15970898|NCT03105414|Device|Mechanical ventilation|Mechanical ventilation
15970899|NCT03105401|Other|Assessment of hallucinations in Parkinson's disease|Patients participating to the study will be asked to answer a semi-structured questionnaire searching for hallucinations of all modalities, minor psychotic symptoms and delusions. Psychometric scales will be assessed to search for depressive symptoms, cognitive impairment and specific personality characteristics.
15970900|NCT03105375|Drug|Single ascending dose of X842|Each subject in a the same cohort will be assigned to the same single dose of X842. The subjects in the subsequent cohort will be assigned to a single dose of X842 based on safety and efficacy data generated from the previous cohort.
15970901|NCT03105375|Drug|Multiple ascending dose of X842|Each subject in a the same cohort will be assigned to the same dose of X842 once daily for five days. The subjects in the subsequent cohort will be assigned to same dose of X842 once daily for five days based on safety and efficacy data generated from the previous cohort.
15970902|NCT03105375|Drug|Losec|Each subject in one cohort will be assigned to a standard dose of omeprazole once daily for five days.
15970903|NCT03105362|Dietary Supplement|Enterade® oral rehydration solution|Commercially available amino acid based oral rehydration solution
15970904|NCT03105349|Drug|elbasvir/grazoprevir|16 weeks treatment
15970905|NCT03105349|Drug|Sofosbuvir|16 weeks treatment
15970906|NCT03105349|Drug|Ribavirin|16 weeks treatment
15970907|NCT03105336|Biological|axicabtagene ciloleucel|A conditioning chemotherapy regiment of fludarabine and cyclophosphamide will be administered followed by a single infusion of CAR transduced autologous T cells administered intravenously.
15970908|NCT03105336|Drug|Cyclophosphamide|Administered intravenously
15970909|NCT03105336|Drug|Fludarabine|Administered intravenously
15970910|NCT03105310|Drug|Pegylated interferon alfa|Pegylated interferon alfa
15970911|NCT03105310|Drug|Ezetimibe|Ezetimibe
15970912|NCT03105297|Device|Prototype nasal dilator strip|External Prototype Nasal Dilator strip. GSK prototype nasal dilator AB 2R11. All the participants used nasal dilator strip throughout the active phase of the study (Day 1 to Day 28). Followed by that all the participants used the nasal strip on Day 29 or 30 in Nasal resistance phase of the study as per their randomization sequence.
15970913|NCT03105297|Other|No strip|
15970914|NCT03105284|Procedure|Liposuction|Fat harvest by liposuction (Colemans method)
15970915|NCT03105245|Other|Electroconvulsive Therapy (ECT) time interval + Anaesthetic (Thiopentone)|The intervention in this study is the time interval between anaesthetic administration and ECT stimulus
15970916|NCT03105219|Drug|Ivabradine|Ivabradine 5mg twice a day (on day 0), heart rate evaluated at day 14 and 28 repeatedly, and the targeted value of heart rate 50-60bpm, the largest dosage 7.5mg twice a day.
15970917|NCT03105219|Other|Sham Comparator|Urinary albumin excretion (UAE) assessment will be performed before randomization (Day 0), 28-day after randomization (Day 28), and 90-day after randomization (Day 28).
15970918|NCT03105206|Procedure|Flexible Ureteroscopy|the Treatment of Low Pole Renal Calculus by Flexible Ureteroscope
15970919|NCT03105193|Drug|IV Saline bolus and infusion|Intravenous bolus of normal saline at induction 3 day postoperative infusion of normal saline administered by ambit pump
15970920|NCT03105193|Drug|IP Saline bolus and infusion|Intraperitoneal bolus of normal saline down first port site. 3 day post operative intraperitoneal infusion of normal saline via an intraperitoneal line inserted by the surgeon. Infusion will be administered by ambit pump.
15970921|NCT03105193|Drug|IV lignocaine bolus and infusion|Intravenous lignocaine bolus at induction. 3 day postoperative IV infusion of lignocaine administered by ambit pump
15970922|NCT03105193|Drug|IP Lignocaine bolus and infusion|Intraperitoneal bolus of lignocaine down first port site. 3 day post operative intraperitoneal infusion of lignocaine via an intraperitoneal line inserted by the surgeon. Infusion will be administered by ambit pump.
15970923|NCT03105180|Other|A mixture of 2.7% sorbitol-0.54% mannitol solution|Venous blood was taken from 12 healthy volunteers and divided into four specimen bottles, which were diluted with different levels (0%, 10%, 20%, and 40%) using a mixture of 2.7% sorbitol-0.54% mannitol solution.
15970924|NCT03105167|Procedure|cortical bone trajectory screws|cortical bone trajectory screws fixation takes the place of traditional pedicle screws fixation will be used in transforaminal lumbar interbody fusion.
15970925|NCT03105167|Procedure|pedicle screws|traditional pedicle screws fixation will be used in transforaminal lumbar interbody fusion.
15970926|NCT03105154|Other|Prevena Dressing|Prevena dressing is applied on one groin
15970927|NCT03105154|Other|Conventional Dressing|Conventional dressing is applied on the contralateral groin
15970928|NCT03105141|Device|Remote ischemic conditioning|"Remote ischemic conditioning is composed of 5 cycles of 5-min bilateral upper limb ischemia intervened by 5-min reperfusion, which is induced by an automated cuff-inflator (Doctormate®) placed on both upper arms and inflated to a given pressure followed by deflation, twice daily for 12 months.
~Two different magnitude of limb ischemia pressure will be set: 200 mmHg and 40 mmHg above systolic pressure (60 patients for each).
~Optimal inflating pressure will be determined based on the results."
15971003|NCT03104634|Drug|Placebo|Placebo and delivery device matched to active intervention
15971071|NCT03104101|Device|TPTNS|Surface adhesive electrodes placed on the skin above medial malleolus
15970929|NCT03105141|Device|Remote ischemic conditioning|"Remote ischemic conditioning is composed of a given cycle of 5-min bilateral upper limb ischemia intervened by 5-min reperfusion, which is induced by an automated cuff-inflator (Doctormate®) placed on both upper arms and inflated to 200 mmHg pressure followed by deflation, twice daily for 12 months.
~The number of cycles of limb ischemia will be set as: 4, 5 and 6 (60 patients for each).
~Optimal cycles for application will be determined based on the results."
15970930|NCT03105141|Device|Remote ischemic conditioning|"Remote ischemic conditioning is composed of 5 cycles of a given duration of bilateral upper limb ischemia intervened by reperfusion, which is induced by an automated cuff-inflator (Doctormate®) placed on both upper arms and inflated to 200 mmHg pressure followed by deflation, twice daily for 12 months.
~The duration of each cycle for limb ischemia will be set as: 4, 5 and 6-min (60 patients for each).
~Ischemia duration algorithm will be determined based on the results."
15970931|NCT03105141|Device|Remote ischemic conditioning|"Remote ischemic conditioning is composed of 5 cycles of 5-min bilateral upper limb ischemia intervened by reperfusion, which is induced by an automated cuff-inflator (Doctormate®) placed on both upper arms and inflated to 200 mmHg pressure followed by deflation, once or twice daily for 12 months.
~The method for application will be set as: once daily for 12 months and twice daily for 12 months (60 patients for each)."
15970932|NCT03105128|Drug|placebo for risankizumab|Placebo for risankizumab administered by intravenous infusion
15970933|NCT03105128|Drug|risankizumab IV|Risankizumab administered by intravenous infusion
15970934|NCT03105128|Drug|risankizumab SC|Risankizumab administered by subcutaneous (SC) injection
15970935|NCT03105115|Drug|fentanyl|intrathecal fentanyl will be added as adjuvant for spinal anesthesia using heavy bupivacaine, while dexmedetomidine will be infused intravenously during operation
15970936|NCT03105115|Drug|bupivacaine only|heavy bupivacaine will be injected intrathecally during spinal anesthesia, without fentanyl, while dexmedetomidine will be infused intravenously during operation
15970937|NCT03105102|Drug|Placebo for Risankizumab SC|Placebo for Risankizumab SC Subcutaneous (SC) Injection
15970938|NCT03105102|Drug|Risankizumab IV|Risankizumab IV Intravenous (IV) infusion
15970939|NCT03105102|Drug|Placebo for Risankizumab IV|Placebo for Risankizumab IV Intravenous (IV) infusion
15970940|NCT03105102|Drug|Risankizumab SC|Risankizumab SC Subcutaneous (SC) injection
15970941|NCT03105102|Drug|Risankizumab On-Body Injector (OBI)|Subcutaneous (SC) injection; on-body injector (OBI)
15970942|NCT03105089|Procedure|ischemic preconditioning|) ischemic preconditioning will be done after induction and before cardiopulmonary bypass by inflation the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3cycles
15970943|NCT03105076|Other|Decision aids|Shared decision making with decision aids
15970944|NCT03105063|Diagnostic Test|ultrasound scan of the hip|validation of Ultrasound test as a tool for diagosing AIIS morphology
15970945|NCT03105050|Other|Access to bariatric surgery|All countries representatives will be interviewed on their Healthcare systems
15970946|NCT03105024|Other|Self-efficacy enhancement|specific instructions regarding the retrieval of mastery experiences during exposure will be given (e.g., pointing out discrepancies between expected negative consequences and actual outcome during exposure; focus on achievements)
15970947|NCT03105024|Other|Control intervention|specific instructions regarding the retrieval of the exposure session will be given without an emphasis on personal mastery experience (e.g., description of details regarding the virtual reality environment)
15970948|NCT03105011|Behavioral|EpxDiabetes software|Subjects will interact daily with a commercially available telemedicine product, Epharmix Diabetes (EpxDiabetes). They will each undergo a baseline blood draw to establish the control HgbA1C associated with standard of care. Three months later they will undergo an experimental blood draw to establish the HgbA1C associated with the use of EpxDiabetes. Between those procedures, the patient will interact with the intervention daily.
15970949|NCT03104998|Drug|Coenzyme Q10|200 mg of CoQ10 or placebo daily by mouth from day 1 till 26 weeks. CoQ10 treatment is safe, even at the highest doses cited in the literature. Most clinical trials have not reported significant adverse effects that necessitated stopping therapy. However, gastrointestinal effects such as abdominal discomfort, nausea, vomiting, diarrhea, and anorexia have occurred. Allergic rash and headache have also been reported
15970950|NCT03104985|Device|LASMIK|the physiotherapeutic device LASMIK (Registration Certificate in Russia № RZN 2015/2687 dated 25.05.2015).
15970951|NCT03104985|Other|Conventional therapy|"An elastic compression of lower extremities,
~Pharmacotherapy,
~Topical treatment"
15970952|NCT03104972|Device|tDCS|Stimulation would be applied using semi-dry 5X5 cm electrodes. The current would be 0.75mA, which based on previous computational modeling of tDCS in children and is estimated to equal that of 1-1.5 mA in adults. This decision was made after considering the parameters that would influence current distribution and density at the site of stimulation such as thinner scalp, less cerebrospinal fluid, and smaller head size of the paediatric population. A similar dosage using tDCS was well tolerated by children, and was not associated with adverse effects29. The anodal electrode will be positioned above the dlPFC (F3 based on the International 10-20 system, while the cathodal electrode would be placed over the right supraorbital.
15970953|NCT03104972|Device|tRNS|Children in the active tRNS group will received 0.75mA of tRNS (100-640Hz) to their left dorsolateral prefrontal cortex (dlPFC) and the right inferior frontal gyrus (IFG) via semi-dry 5cm X 5cm electrodes, attached under designated electrode positions (F3, F8) of a tES cap that followed the International 10-20 system (InnoSphere Inc., Haifa). The left dlPFC and right IFG were chosen, based on their contribution in executive control and inhibition. tRNS will be applied for 20 minutes per session during an iPad cognitive training. Similar duration has also been used in paediatrics using tDCS29. Similar to a previous tRNS study in children, and the rational provided for tDCS we will apply 0.75mA.
15970954|NCT03104972|Device|sham|For sham-tRNS we will use the same montage as in active tRNS. For sham-tDCS we will use the same montage as in active tDCS. The only difference between active and sham tES would be that in the case of the sham tES the 30 sec of ramp up of the current from 0 to 0.75mA would not be followed by 19 min of stimulation at 0.75mA as in active tES, but would immediately be followed by 30 sec ramp down period to 0mA. Such method has been shown to provide effective blindness of the stimulation condition as both active and sham tES would lead to slight itching sensation that would disappear due scalp habitation. No further stimulation would be provided in the sham group during the daily session.
15970955|NCT03104959|Dietary Supplement|N-acetyl cysteine|
15970957|NCT03104946|Diagnostic Test|Mental Development Index;Auditory Brainstem Response;okineticnystagmus|mental development index(MDI）<70:cognitive delay do not pass auditory brainstem response(ABR）：hearing impairment do not pass okineticnystagmus:visual impairment Patent Ductus Arteriosus
15970958|NCT03104920|Procedure|ERAS Program|An ERAS pathway comprises of optimized management of diet, mobilization, multimodal perioperative analgesia and GI function recovery modalities.
15970959|NCT03104920|Procedure|Traditional treatment|A traditional perioperative management for HCC.
15970960|NCT03104907|Procedure|Prostatic Artery Embolization|The procedure is performed with the patient under local anaesthetic and if necessary sedation. We will be using a percutaneous transfemoral approach, super-selective catheterisation of small prostatic arteries is carried out using microcatheters. Embolisation will be done using microspherical embolic material.
15970961|NCT03104894|Procedure|Meibomian Glands Massage|Meibomian gland expression
15970962|NCT03104894|Procedure|Sham Meibomian Glands Massage|Touching the eyelids gently
15970963|NCT03104894|Device|Meibomian Massage device|Meibomian glands expression with applicator
15970964|NCT03104881|Device|3D exoskeleton type robot|3 dimension exoskeleton type upper extremity robot
15970965|NCT03104881|Device|2D end-effector type robot|2 dimension end-effector type upper extremity robot
15970966|NCT03104868|Behavioral|TAKE IT Strategy|"The TAKE IT Strategy includes:
~Programming the electronic health record (EHR) to organize/simplify daily regimen schedules and generate electronic, tangible, print, low literacy medication education materials at every clinical encounter.
~SMS text-messaging to remind patients when to take all their medicine.
~A web-based patient portal that requests patients to periodically report upon their medication use, providing a continuous link between the transplant center and patient beyond routine in-person visits.
~EHR notifications directed to the transplant center nurse coordinator if an adherence-related problem is identified by the web-based portal assessment, who then can activate appropriate staff to respond."
15970967|NCT03104855|Drug|d6-25-hydroxyvitamin D3|intravenous administration of stable isotope-labeled D6-25(OH)D3
15970968|NCT03104842|Drug|Isatuximab|Antibody Intravenous
15970969|NCT03104842|Drug|Carfilzomib|Intravenous
15970970|NCT03104842|Drug|Lenalidomide|Capsel
15970971|NCT03104842|Drug|Dexamethasone|Capsel
15970972|NCT03104829|Behavioral|Motivational interviewing|
15970973|NCT03104829|Drug|DSME participants in this arm will receive standard care for diabetes (DSME) at the beginning of the study and 3 months later|
15970974|NCT03104816|Drug|Acetaminophen IV Soln 10 MG/ML|
15970975|NCT03104816|Drug|Acetaminophen|
15970976|NCT03104816|Drug|Hydromorphone|
15970977|NCT03104803|Device|long-term paired associative stimulation|Paired associative stimulation (PAS) administered several times per week for 6 weeks to one hand. PAS comprises transcranial magnetic stimulation (eXimia magnetic stimulator, Nexstim Ltd, Helsinki, Finland) and peripheral nerve stimulation (given with Dantec Keypoint® electroneuromyography device (Natus Medical Incorporated, Pleasanton, CA, USA)).
15970978|NCT03104790|Biological|Fluenz Tetra (The two groups are defined by immunisation history, all receive the same intervention in the study)|live attenuated influenza vaccine (LAIV)
15970979|NCT03104777|Behavioral|Behaviourally Informed Intervention Materials|"The intervention consists of 7 separate components. The intervention components are to be delivered at three time-points (referred to as bundles). The bundles consist of:
~Bundle 1a - Letter to parents of children bringing a packed lunch to school, 'spot the difference' lunch box tag (attached to all lunchboxes) and a Handy Swaps Card.
~Bundle 1b - Letter to parents of children only having school meals and a Handy Swaps Card.
~Bundle 2 - Lunch box mixer with ideas for creating nutritious packed lunches. Bundle 3 - Shopping list, packed lunch planner and reward chart to support planning and monitoring progress."
15970980|NCT03104764|Device|Scalpel|Labial frenulum removed by scalpel
15970981|NCT03104764|Device|Er:YAG laser|Labial frenulum removed by Er:YAG laser
15970982|NCT03104738|Other|25% reduction of basal insulin dose|"Subjects will be instructed to reduce their basal insulin dose to 75% instead of our institutional 50%.
~Subject must check their own blood sugar before reporting to the hospital for their surgery. If the value is less than 70 or subjects are having symptoms of hypoglycemia, subjects will be instructed to immediately ingest 4-8 oz of fruit juice (without pulp) and call their doctor or the hospital."
15970983|NCT03104725|Drug|N-Acetylcysteine|Oral
15970984|NCT03104725|Procedure|Lumbar Puncture|Each participant undergoes a baseline lumbar puncture (LP 1) as an inpatient at the NIH Clinical Center to obtain cerebrospinal fluid (CSF) for assays of Cys-DA, 3,4-dihydroxyphenylacetic acid (DOPAC), and related biochemicals. The second LP (LP 2) is completed after the PD participant has taken at least 5 doses of NAC (2 grams orally twice per day) and approximately 2 hours after the last NAC dose. For the HV participant, LP 2 occurs approximately 48 hours after LP 1 (no NAC administered).
15970985|NCT03104725|Radiation|Fluoroscopy|If needed for lumbar puncture
15970986|NCT03104712|Other|Glucose #1|50g available carbohydrate
15970987|NCT03104712|Other|Glucose #2|50g available carbohydrate
15970988|NCT03104712|Other|Glucose #3|50g available carbohydrate
15970989|NCT03104712|Other|Spaghetti|50g available carbohydrate
15970990|NCT03104712|Other|Rice|50g available carbohydrate
15970991|NCT03104712|Other|Spaghetti + Tomato Sauce|50g available carbohydrate
15970992|NCT03104712|Other|Rice + Tomato Sauce|50g available carbohydrate
15970993|NCT03104712|Other|Spaghetti + Pesto|50g available carbohydrate
15970994|NCT03104712|Other|Rice + Pesto|50g available carbohydrate
15970995|NCT03104699|Drug|AGEN2034|Anti-PD-1 Monoclonal Antibody
15970996|NCT03104686|Other|Short pasta (dry)|50g available carbohydrate of penne pasta
15970997|NCT03104686|Other|Long pasta (dry)|50g available carbohydrate of spaghetti pasta
15970998|NCT03104686|Other|Bread|50g available carbohydrate of bread
15970999|NCT03104686|Other|Glucose|50g available carbohydrate of glucose monohydrate
15971000|NCT03104660|Device|CE certified mitral valve repair systems|Patients receive a transcatheter mitral valve repair with CE certified transcatheter mitral repair systems.
15971001|NCT03104647|Other|VRP-Clinic|Subjects will perform a series of neck movements guided by graphic instructions appearing in the virtual reality environment
15971004|NCT03104621|Drug|Benzalkonium chloride (BAK)|Benzalkonium chloride (BAK) is the most used preservative and is excellent for safety and stability of drug. However, it causes dry eye, corneal oedema, corneal erosion, and corneal toxicities, thus lowering the long-term tolerability for patients. A critical component when managing glaucoma patients is ensuring compliance.
15971005|NCT03104621|Drug|0.0015% tafluprost|Tafluprost (trade names Taflotan or Taflotan-S by Santen Pharmaceutical) is a prostaglandin analogue. It is used topically (as eye drops) to control the progression of open-angle glaucoma and in the management of ocular hypertension. In this study, tafluprost was used in all experimental group with equally concentration(0.0015%), only measured whether BAK was included or not.
15971006|NCT03104608|Other|Automatic Self Transcending Meditation|Automatic Self Transcending Meditation is a class of meditation that helps quiet the mind and induces physiological and mental relaxation whilst the eyes are shut. It utilizes a specific sound value (mantra) to draw attention inward and permit the mind to experience a restful but alert state of consciousness. Research suggests that ASTM is easier to learn and to teach in comparison to other meditation techniques. Further, studies have shown that ASTM confers large effect sizes as an anti-depressant.
15971007|NCT03104608|Other|Treatment as Usual|Participants randomized to Treatment as Usual (TAU)) will continue to receive their treatment as usual.
15971008|NCT03104595|Drug|EC-18|oral administration
15971009|NCT03104582|Procedure|ERCP Drainage|When advanced Klatskin Tumor patients need biliary drainage, they choose to perform endoscopic drainage after informed consent.
15971010|NCT03104582|Procedure|PTBD Drainage|When advanced Klatskin Tumor patients need biliary drainage, they choose to perform percutaneous transhepatic biliary drainage after informed consent.
15971011|NCT03104569|Procedure|Injection of 37℃ contrast agent|Nonionic contrast agent is heated to 37℃ in a incubator when injection of contrast agent
15971012|NCT03104543|Behavioral|Education|30 minute education session; 15 minute booster session at 4 months
15971013|NCT03104543|Behavioral|Test results only|The control group will receive a copy of test results upfront but not experimental educational materials; those will be available at 1 year
15971014|NCT03104530|Other|Brown crabmeat|Those exposed to higher levels of cadmium due to habitual consumption of 40 grams or more per week of brown meat from crab
15971015|NCT03104517|Biological|AMDC-USR|Autologous Muscle Derived Cells for Urinary Sphincter Repair
15971016|NCT03104517|Other|Placebo|Placebo control is the vehicle solution used for the study product.
15971017|NCT03104504|Behavioral|Suicide Risk Screening|Suicide risk screening will be implemented as the standard of care for all patients who present for treatment.
15971018|NCT03104504|Behavioral|Safety Planning|Suicide screen-positive patients who are to be discharged from the hospital will receive personalized safety planning by a mental health clinician or nurse that includes means restriction counseling as a step in the safety plan.
15971019|NCT03104504|Behavioral|Care transition facilitation|Include post-acute telephone phone call follow-up to foster engagement with outpatient care and problem solving within 24 hours of discharge
15971020|NCT03104504|Behavioral|A Lean Implementation Strategy|The Interventions will be implemented using Lean performance improvement strategies
15971021|NCT03104491|Drug|Inotuzumab Ozogamicin|"Inotuzumab ozogamicin, IV, 28 day cycles
~ALL Phase 1 dosages:
~Dose Level -2 (0.1 mg/m^2)
~Dose Level -1 (0.2 mg/m^2)
~Dose Level 0 (0.3 mg/m^2)
~Dose Level 1 (0.4 mg/m^2)
~Dose Level 2 (0.5 mg/m^2)
~Dose Level 3 (0.6 mg/m^2)
~NHL Phase 1 dosages:
~Dose Level -1 (0.2 mg/m^2)
~Dose Level 0 (0.3 mg/m^2)
~Dose Level 1 (0.4 mg/m^2)
~Dose Level 2 (0.5 mg/m^2)
~Dose Level 3 (0.6 mg/m^2)
~Dose Level 4 (0.7 mg/m^2)
~Dose Level 5 (0.8 mg/m^2)"
15971022|NCT03104478|Procedure|Biological samples collection|In addition to collection and characterization of tumor biopsy samples done for diagnosis (standard care), collection of blood samples at study entry for further biological analyses.
15971023|NCT03104465|Behavioral|Mindfulness Training|interactive. web-based mindfulness training complemented with mobile application
15971024|NCT03104439|Drug|Nivolumab|The antibodies in nivolumab work by causing programmed cell death of the cancer cells
15971025|NCT03104439|Drug|Ipilimumab|The antibodies in ipilimumab work by not allowing cancer cell growth
15971026|NCT03104439|Radiation|Radiation Therapy|Radiation therapy is believed to increase the likelihood of response of immunotherapy
15971027|NCT03104426|Drug|Darbepoetin Alfa|Darbepoetin alfa dosage 10microg/kg once a week for 8 weeks
15971028|NCT03104413|Drug|placebo for risankizumab IV|placebo for risankizumab administered as intravenous (IV) infusion.
15971029|NCT03104413|Drug|risankizumab SC|risankizumab administered by subcutaneous (SC) injection
15971030|NCT03104413|Drug|risankizumab IV|risankizumab administered as intravenous (IV) infusion.
15971031|NCT03104400|Drug|Adalimumab|Adalimumab subcutaneous injection
15971032|NCT03104400|Drug|ABT-494|Oral tablet
15971033|NCT03104400|Drug|Placebo for ABT-494|Oral tablet
15971034|NCT03104400|Drug|Placebo for Adalimumab|Subcutaneous injection
15971035|NCT03104387|Other|Electric train|Exposure to air with low level of ultrafine particles (Electric train)
15971036|NCT03104387|Other|Diesel train|Exposure to air with high level of ultrafine particles (Diesel train)
15971037|NCT03104374|Drug|Placebo|Oral tablet
15971038|NCT03104374|Drug|ABT-494|Oral tablet
15971039|NCT03104361|Biological|Platelet-Rich Plasma|Patients who meet all eligible requirements for entry into the study will be treated with intravesical injection of PRP (extracted from 50ml whole blood ) at 20 sites
15971040|NCT03104348|Diagnostic Test|COPD screening|Self-questionnaire with 5 questions Fagerström's test Spirometry
15971041|NCT03104335|Drug|Apatinib|750 mg daily once oral administration of apatinib for body surface area (BSA) > 1.5 and 500mg daily for BSA <1.5. Half an hour after meal and everyday at the same time is usually advised.
15971042|NCT03104322|Other|patientMpower platform|electronic health journal for patient to record compliance, spirometry, impact on daily life and symptoms
15971043|NCT03104322|Other|usual care|usual care
15971044|NCT03104309|Device|Levonorgestrel intrauterine system|Levonorgestrel intrauterine system for adenomyosis
15971069|NCT03104114|Behavioral|Historical control|Patients that did not receive in-person motivational counseling support from a clinical pharmacist prior and during treatment
15971070|NCT03104101|Combination Product|TPTNS+Drug|one tablet Trospium Chloride 20 mg once daily Plus TPTNS
15971045|NCT03104296|Diagnostic Test|Griffiths Mental Development Scales|"Griffiths Mental Development Scales investigate 5 main areas (locomotor, personal and social skills, hearing and language, eye and hand coordination, performance), providing a general developmental quotient (DQ) of infant's abilities and five sub-scale quotients (SQ) for each developmental area.
~The assessments are performed individually in a quiet room, over a 45-min period, by the same professional trained psychologist for the whole study period and are implemented in the presence of the infant's parent. The obtained results are adjusted for corrected age, in order to consider the neurobiological maturation of the enrolled infants."
15971046|NCT03104283|Drug|Apatinib|take apatinib orally until disease progression or appearance of unbearable toxicity
15971047|NCT03104270|Drug|Elotuzumab|Elotuzumab IV at 10mg/kg Elotuzumab IV at 20mg/kg
15971048|NCT03104270|Drug|Pomalidomide|Pomalidomide PO at 3mg
15971049|NCT03104270|Drug|Carfilzomib|Carfilzomib 20mg/m2 IV Carfilzomib 56mg/m2 IV
15971050|NCT03104270|Drug|Dexamethasone|Dexamethasone 28mg PO Dexamethasone 40mg PO or IV Dexamethasone 8mg IV
15971051|NCT03104257|Drug|[11-C]OMAR|The radiotracer, [11-C]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.
15971052|NCT03104231|Other|three-dimensional (3D) movie|Brief VR-3D will be shown using the oculus glasses and a smartphone. Then, patients will be asked several questions from the prepared questionnaire.
15971053|NCT03104218|Other|tDCS group|Interventions: movement training, strengthening, patient education. tDCS will be delivered using a direct current stimulator (constant current of 1.5 mA) via two 35cm2 (5 x 7 cm) saline-soaked surface sponge electrodes (parameters shown effective to enhance training).40 The center of the active electrode will be positioned over C3/C4 (international 10-20 EEG system; corresponding to the cortical representation of upper limb muscles)57, contralateral to the side of pain and the reference electrode over the contralateral supraorbital region. Current intensity will be ramped up (0-1.5 mA) and down (1.5-0 mA) over 15 seconds at the beginning and end of the 30 minutes stimulation period.
15971054|NCT03104218|Other|Placebo group|"Interventions: movement training, strengthening, patient education. The sham tDCS involves electrodes placed in an identical position to that used for active stimulation; however the stimulation will be turned on for 15 seconds and then off to provide participants with the initial itching sensation but without current for the remainder of the period. This procedure has been shown to effectively blind participants to the stimulation condition."
15971055|NCT03104205|Behavioral|Evaluate home-based MOWI|MOWI will be delivered via video-conferencing in the subject's home in a 3x per week, 26-week program from the coordinating center. It will include an individual dietician-led weekly nutrition session; 2x/week physical therapist-led group exercise session; and remote fitness device monitoring. We plan 5 cohorts of 8 subjects (n=40). In-person Research Assistant-led assessments will occur at 0, 8, 16 and 26 weeks. Recruitment, screening, selection criteria, and usability parallel Aim 2 (NCT03104192).
15971056|NCT03104192|Behavioral|Develop & Refine MOWI w/o Amulet|The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks.
15971057|NCT03104192|Behavioral|MOWI Weight Loss Maintenance|Participants who successfully completed the initial MOWI program will be offered the opportunity to participate in a 6-month weight management program. This program will consist of 8 group-based skills workshop sessions occurring approximately once monthly (every 3 weeks), which will be 90-120 minutes in length. The overall structure of the program will emphasize the following evidence-based weight management components: Goal setting/action planning, self-monitoring, receiving feedback regarding performance, reviewing relevant goals in the light of feedback, and e. psychological skills for increasing behavioral commitment (acceptance, willingness, thought monitoring, mindful decision making, and values clarification).
15971058|NCT03104192|Behavioral|Develop & Refine MOWI w Fitbit|The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance.
15971059|NCT03104192|Dietary Supplement|Develop & Refine MOWI w Fitbit/Protein|The mHealth Obesity Wellness Intervention (MOWI) will be informed by the previous Aim (Aim 1) of this proposal. It will consist of a 12-week, 3x/week program of: weekly nutrition counseling; 2x/week group exercise visits; and Fitbit to monitor activity. A dietician and physical therapist will lead the in-person sessions. A wave of 8 individuals each will be assessed at 0, 4, 8 and 12 weeks and will also be given Amulet to measure steps, activity type, duration and distance. We will provide whey protein 3x/week after exercise sessions.
15971060|NCT03104179|Device|Cytosorb Adsorber|Cytokine adsorption during CPB
15971061|NCT03104166|Device|Medium Cut-Off (MCO) dialysis membrane|Patients will be treated with a CE-certified dialysis membrane that provide enhanced clearance for middle-sized molecules, call Medium Cut-Off membrane.
15971062|NCT03104166|Device|High-Flux dialysis membrane|Control: Patients will be treated with a CE-certified High-Flux dialysis membrane.
15971063|NCT03104153|Procedure|Early-drain removal|Drain removal at hospital discharge
15971064|NCT03104140|Drug|Ketamine|After fluid resuscitation, patients will receive :1 mg/Kg ketamine + 0.5 ug/Kg fentanyl + 0.05 mg/Kg midazolam for induction of anesthesia
15971065|NCT03104140|Drug|Thiopental|After fluid resuscitation, patients will receive :2 mg/Kg Thiopental + 0.5 ug/Kg fentanyl + 0.05 mg/Kg midazolam for induction of anesthesia
15971066|NCT03104127|Device|Alter G Bionic Leg|Participants are randomized to a 10 week, community-based bionic leg programme. Participants must use the leg for a minimum of 1 hour per day and continue to have active physical therapy sessions.
15971067|NCT03104127|Other|Normal therapy (physiotherapy)|Participants are randomized to a normal therapy (physiotherapy) only program. Participants are also advised to undertake 1 hour a day of physical activity and have active physical therapy (physiotherapy) sessions.
15971068|NCT03104114|Behavioral|pharmacist-intervention|A clinical pharmacist provides patients with motivational counseling regarding their cancer treatments. Patients will be asked to complete three different surveys throughout the study; surveys focus on social support systems and both provider- and pharmacist-patient relationships
15971072|NCT03104088|Diagnostic Test|CANTAB|CANTAB Cognitive Assessment (tablet based cognitive testing from CAMCOG)
15971073|NCT03104088|Diagnostic Test|MOCA|Montreal cognitive assessment (MOCA) in German
15971074|NCT03104075|Biological|Pneumococcal 13valent Conj Vaccine Diphtheria CRM197 Protein|One to two years after receiving the randomly-assigned vaccination, participants may opt to receive administration of a second pneumococcal vaccine with Pneumovax 23
15971075|NCT03104075|Biological|Pneumococcal Vaccine Polyvalent|One to two years after receiving the randomly-assigned vaccination, participants may opt to receive administration of a second pneumococcal vaccine with Prevnar-13
15971076|NCT03104062|Diagnostic Test|Microbubble Contrasted Echocardiography|Myocardial Perfusion Score Index (MPSI) obtained using Microbubble Contrasted Echocardiography
15971077|NCT03104062|Diagnostic Test|Platelet Aggregability|Obtained using Multiplate Analyzer
15971078|NCT03104062|Diagnostic Test|Laboratory|it will be collected at patients arrival, Reative C-Protein, BNP, CK-mass, Troponine, interleukine-6, Creatinine.
15971079|NCT03104049|Device|Neuromuscular taping|"NMT applications:
~rhomboid major muscle
~muscles abdominals
~spinal muscles
~pectoralis major muscles
~gastrocnemius muscle
~upper trapezius muscle
~anterior muscles of the neck"
15971080|NCT03104036|Other|Faecal bacterial transplantation|Enema prepared from 50 g of stool of examined donor dissolved in 150 ml of normal saline
15971081|NCT03104036|Drug|Mesalazine 4G Enema|Standard mesalazine enema
15971082|NCT03104023|Procedure|Staple line inversion|A staple line inversion will be performed with a running suture of Polypropylene 2/0
15971083|NCT03104023|Combination Product|Staple line buttressing|The gastric section will be performed with a stapler with preloaded buttress material
15971084|NCT03104010|Drug|Somatropin Injection|Recombinant human growth hormone injection, 15IU/5mg/3ml/bottle. The first stage , 0.17mg/d(0.5IU/d), subcutaneous injection ,daily, 26weeks. The second stage(extension period study), 0.17mg/d(0.5IU/d), maximum ≤0.68mg/d (2IU/w),52 weeks.
15971085|NCT03103997|Procedure|EUS-guided liver biopsy|EUS-guided liver biopsy using needles with various preparations
15971086|NCT03103984|Other|Weight loss diet|Weight loss diet composed of 30% lipids, 30% proteins and 40% carbohydrates.
15971087|NCT03103971|Biological|Autologous Human Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing CD4+/CD8+ T-lymphocytes|Given IV
15971088|NCT03103971|Drug|Cyclophosphamide|Given IV
15971089|NCT03103971|Drug|Fludarabine|Given IV
15971090|NCT03103971|Other|Laboratory Biomarker Analysis|Correlative studies
15971091|NCT03103971|Procedure|Leukapheresis|Undergo leukapheresis
15971092|NCT03103971|Other|Pharmacological Study|Correlative studies
15971093|NCT03103958|Dietary Supplement|Probiotic|"Probiatop is a live microbial preparation saches containing 1g of the formulation composed by Lactobacillus acidophilus NCFM, 10⁹, Lactobacillus rhamnosus HN001 10⁹, Lactobacillus paracasei LPC-37 10⁹, Bifidobacterium lactis HN019 10⁹ combined with Polydextrose.
~Subjects will take two sachets per day after diluting them in 100 ml of water"
15971094|NCT03103958|Dietary Supplement|Placebo|"The placebo sachets were prepared by substituting equivalent amounts of Maltodextrin for the probiotic powder.
~Subjects will take two sachets per day after diluting them in 100 ml of water"
15971095|NCT03103945|Device|CDS box connection of the Niobe™ Remote Magnetic Navigation System|For all subjects included in the study, the ablation procedure will be started per standard of care. First mapping, pacing and electrocardiograms of the right atrium will be evaluated without the CDS box connected. Second the CDS box will be connected to the catheter and mapping, pacing and electrocardiograms will be recorded again. Next, ablation will be conducted per standard of care.
15971096|NCT03103932|Other|Biomarker guided discharge algorithm|participants randomized to the biomarker guided discharge algorithm will follow a pre-determined care pathway for treatment of heart failure symptoms based on admission NTproBNP levels
15971097|NCT03103919|Device|Kinesia-ONE™|Kinesia-ONE™ wearable sensor uses a subject-worn finger sensor and iPad mini application (APP) to objectively measure specific motor tasks related to Parkinson's disease symptoms such as tremor, bradykinesia (slowed movements), and dyskinesia (involuntary movements) in the Investigator's office. Subjects should wear the Kinesia-ONE™ device on the most affected side.
15971098|NCT03103919|Device|Kinesia-360™|Kinesia-360™ wearable sensor includes a wrist and ankle device, along with a cell phone, which is also APP-based, and is designed for continuous day time monitoring of Parkinson's disease symptoms. Subjects will wear Kinesia-360™ while they go about their daily lives, and symptom severity is continually captured to enable objective assessment of Parkinson's disease symptoms. Subjects should wear the Kinesia-360™ device bands on the most affected side.
15971099|NCT03103919|Drug|Rotigotine|All subjects will start Neupro treatment at a dose of either rotigotine 2 mg/24 h or 4 mg/24 h (according to the disease stage of the subject) which will then be adjusted based on symptom assessment either via standard care alone or via a combination of standard care and evaluation of the recordings made available by the Kinesia wearable technologies.
15971100|NCT03103906|Other|Cream (Test product)|Moisturizing cream with SPF (Sun protecting factor) 20
15971101|NCT03103906|Other|Cleanser (Reference Product)|Moisturizing facial cleanser
15971102|NCT03103906|Other|Sunscreen (Reference Product)|SPF 50 sunscreen
15971103|NCT03103893|Drug|Rapamycin|topical formulation
15971104|NCT03103880|Device|mHealth Asthma Adherence System|This Intervention includes the use of the mobile application and connected sensors to track adherence and engage patients in their care.
15971105|NCT03103880|Device|Remote Mobile Pulmonary Function Testing|This intervention includes remote patient monitoring of lung function using a connected spirometer used to capture pulmonary function testing (PFTs) monthly.
15971106|NCT03103880|Device|Remote Mobile Peak Flow Capture|This intervention includes remote patient monitoring of lung function using a connected spirometer used to capture peak flow and FEV1 metrics weekly.
15971107|NCT03103867|Device|CGM augmented pump with PLGS ,|5 weeks treatment CGM augmented pump with PLGS compared with 5 weeks treatment with insulin pump with CGM , without integration
15971108|NCT03103867|Device|Insulin pump with CGM|5 weeks treatment continuous subcutaneous insulin infusion pump with CGM without data integration,
15971109|NCT03103854|Behavioral|BURST physical activity|BURST is a novel exercise regimen consisting of three daily periods of 10 minutes of high intensity physical activity spread throughout the day.
15971110|NCT03103854|Behavioral|Text Message Reminders|Patients were sent daily text message reminders to remind them to exercise.
15971111|NCT03103854|Behavioral|Moderate Intensity Continuous Training|This is the current standard of care for cardiac rehabilitation patients. It consists of 1 daily period of 30 minutes of moderate intensity physical activity.
15971112|NCT03103841|Procedure|Sleep studies [Polysomnography]|Undertaking of sleep measurements by polysomnography and use of validated sleep questionnaires
15971113|NCT03103828|Behavioral|Computer-Tailored Intervention|CTI will receive telephone contact at three time points: baseline, two, and four months. Each contact consists of an integrated assessment and intervention feedback report, using an expert system. Participants are assessed for four different behaviors that together represent complete ACP engagement: communication with loved ones about views on quality of life versus quantity of life, communication with clinicians about views on quality of life versus quantity of life, assignment of a health care surrogate, and completion of a living will. The system takes the results of the assessment and results in an individualized feedback report.
15971114|NCT03103828|Behavioral|Motivational Interviewing|MET will receive telephone contact at three time points: baseline, two, and four months. They will undergo the assessment as described above receive and they will receive a second a telephone contact within two weeks of the assessment, which will consist of an MET session. If the surrogate has been enrolled in the study, the MET will be conducted with both the Veteran and the surrogate in a dyadic telephone interview. The goal of the interview is to strengthen commitment to engage in ACP and promote self-efficacy. The interviewer will also help the Veteran to reflect on the pros and cons of ACP engagement as elicited in the assessment process, to understand how to build on ACP behaviors already engaged in, and, if appropriate, to help the Veteran create a change plan for further ACP engagement.
15971115|NCT03103828|Behavioral|Motivational Enhancement Therapy|Participants assigned to CTI+MET will receive the CTI intervention at baseline, two months, and four months as described above. with a follow-up MET session as described above occurring within two weeks of each contact.
15971116|NCT03103815|Drug|Amivita|In each course, Amivita solution (500ml) will be administrated i.v. once daily for 4 weeks. After an interval of 2 weeks, the participants will be treated again. A total of 7 courses will be given,
15971117|NCT03103802|Device|intra-oral digital scanner and extra-oral digital scanner|intra-oral and extra-oral digital scanners used to obtain digital models
15971118|NCT03103789|Diagnostic Test|single catheter mucosal impedance testing|
15971119|NCT03103789|Diagnostic Test|balloon assembly mucosal impedance testing|
15971120|NCT03103776|Other|Comparison of Positive PCR Frequencies for Polyomavirus in Blood, Urine and / or Thyroid Tissue vs Basedow / Hashimoto|Comparison of Positive PCR Frequencies for Polyomavirus in Blood, Urine and / or Thyroid Tissue vs Basedow / Hashimoto
15971121|NCT03103763|Drug|Warfarin|Patients on warfarin for atrial fibrillation
15971122|NCT03103750|Procedure|Magnetic Resonance Imaging (MRI)|Magnetic resonance imaging (MRI) scans (3 T) will be collected in each subject for the purposes of excluding participants with anatomical abnormalities and anatomically co-registering PET and MRI for image analysis
15971123|NCT03103750|Drug|PHNO|Used as a tracer for in vivo imaging.
15971124|NCT03103750|Dietary Supplement|calcitriol|three 0.5 mcg capsules
15971125|NCT03103750|Drug|Placebo oral capsule|three 0.5 mcg capsules
15971126|NCT03103750|Procedure|high-resolution research tomography|A functional imaging technique that is used to observe metabolic processes in the body.
15971127|NCT03103750|Drug|Dextro Amphetamine|Dexedrine 0.3 mg/kg, to a maximum dose of 30 mg
15971128|NCT03103737|Behavioral|Virtual Reality (VR) and Reminiscence Intervention|First and third sessions are dedicated to remember positive and meaningful personal experiences. Second and fourth sessions are oriented to positive emotions by the use of VR. Participants can choose the virtual environment to work with.
15971129|NCT03103724|Drug|Xtandi|Enzalutamide 160 mg (4 x 40 mg capsules), orally once daily
15971130|NCT03103711|Behavioral|Virtual Reality Intervention|"Participants receive two sessions oriented to joy and two focused on relax. In the first 2 sessions patients can choose the environment (Emotional Parks or Walk through Nature) and in the following ones participants visit the alternate environments."
15971131|NCT03103698|Device|To demonstrate the monitoring of perioperative analgesia|To demonstrate that the monitoring of perioperative analgesia by the ANI device decreases intraoperative morphine consumption compared with conventional monitoring based on haemodynamic variations.
15971132|NCT03103698|Other|Standard preoperative evaluation of analgesia|To demonstrate that the monitoring of perioperative analgesia by the ANI device decreases intraoperative morphine consumption compared with conventional monitoring based on haemodynamic variations.
15971133|NCT03103685|Drug|Clopidogrel|The patient s in experimental arm will not be ask to stop P2Y12 inhibitor such as Clopidogrel, Prasugrel or Ticagrelor
15971134|NCT03103672|Procedure|Percutaneous transhepatic cholangiography|Percutaneous transhepatic cholangiography (PTC) can be performed via the right midaxillary approach, though a subxiphoid approach is occasionally needed
15971135|NCT03103659|Other|personalised care plan|Quality of life assessement in elderly cancer patients
15971136|NCT03103646|Drug|Lu AF35700|Tablets for oral use, single dose in a fasted state. EMs: 10 mg/day, PMs: 5 mg
15971137|NCT03103646|Drug|Itraconazole (200 mg)|100 mg Capsules for oral use, 200 mg/day. In a fed state
15971138|NCT03103646|Drug|Itraconazole (300 mg)|100mg Capsules for oral use, 300 mg/day. In a fasted state.
15971139|NCT03103633|Procedure|mean artery pressure|mean artery pressure declined with less than 20% of baseline
15971140|NCT03103633|Procedure|bispectral index|BIS 45-60 before and after CPB; and BIS 40-45 during CPB
15971141|NCT03103633|Procedure|Brain oxygen saturation|Brain oxygen saturation declined with less than 20% of baseline
15971142|NCT03103633|Other|Controlled|receiving standard measures to achieve a heart rate (HR) in the range of 60-100 beats/min, central venous oxygen saturation (Svco2) higher than 70%, lactate level lower than 3 mmol/L, hematocrit value higher than 28%, and urinary output higher than 0.5 mL/kg/hr.
15971143|NCT03103620|Device|COBRA PzF Coronary Stent System|COBRA PzF Coronary Stent System
15971144|NCT03103607|Diagnostic Test|Ophthalmological evaluation|exophthalmometry, evaluation of the Clinical Activity Score (CAS), assessment of diplopia, measurement of visual acuity, assessment of the corneal status; examination of the fundi
15971145|NCT03103607|Diagnostic Test|Questionnaire|Patients were asked to fill a questionnaire on self-perception related to GO with the following questions: i) are your eyes identical to the way they were before GO appeared?; ii) are your eyes normal? iii) do you have any limitations in daily activities related to your eyes?; iv) do you have any limitations in social life related to your eyes?
15971146|NCT03103594|Drug|DMSO|DMSO will be instilled intravesically.
15971147|NCT03103594|Drug|Botox|Botox will be instilled intravesically with DMSO.
15971148|NCT03103581|Drug|BLI4700|BLI4700 Bowel Preparation (Investigational Regimen)
15971149|NCT03103568|Drug|Nitisinone in Arm A|4 capsules of 20 mg nitisinone (80 mg) is given once daily for 17 days.
15971150|NCT03103568|Drug|Tolbutamide|A 500 mg tablet is given as single oral dose 2 weeks apart.
15971151|NCT03103568|Drug|Metoprolol|A 50 mg tablet of metoprolol tartrate is given as single oral dose 2 weeks apart.
15971152|NCT03103568|Drug|Chlorzoxazone|A 250 mg tablet is given as single oral dose 2 weeks apart.
15971153|NCT03103568|Drug|Furosemide|A single intravenous dose of 20 mg administered as an i.v. infusion is given 2 weeks apart.
15971154|NCT03103568|Drug|Nitisinone in Arm B|4 capsules of 20 mg nitisinone (80 mg) is given once daily for 16 days.
15971155|NCT03103555|Drug|Bortezomib|Bortezomib will be subcutaneously administered in 2 treatment cycles with 4 injections of 1.3 mg Bortezomib /m2 body surface per cycle.
15971156|NCT03103555|Drug|Cyclophosphamide|Low dose cyclophosphamide will be given orally for 4 month after completion 2 cycles of bortezomib
15971157|NCT03103542|Biological|Recombinant coagulation factor (rFVIIIFc)|"rFVIIIFc 200 IU/kg/day during ITI Period and thereafter adjusted according to the Investigator's judgement
~administered intravenously."
15971158|NCT03103529|Other|Active Rehabilitation|
15971159|NCT03103516|Procedure|early epidural decompression group|The patients will be assigned to early (within 24 hours after spinal cord injury) epidural decompression group (n=100) according to the patient's condition and operation time.
15971160|NCT03103516|Procedure|delayed epidural decompression group|The patients will be assigned to delayed (exceed 24 hours after spinal cord injury) epidural decompression group (n=100) according to the patient's condition and operation time.
15971161|NCT03103490|Drug|18F-FSPG|Patients will receive 8mCi of 18F-FSPG and undergo PET/MRI or PET/CT imaging to determine the ability of 18F-FSPG to localize to cardiac sarcoidosis or myocardial inflammation and the utility of PET/MR to detect these conditions.
15971162|NCT03103477|Other|Urine stability|This study is proposing to assess PAF and PAF-AH activity in urine after using various handling methods of the urine specimen. Better understanding of PAF stability will allow for better design of future experiments involving PAF in interstitial cystitis patients.
15971163|NCT03103464|Other|Standard-of-Care Therapy + Sit-to-Stand Therapy|Standard-of-care physical therapy 3x/wk for approximately 30 minutes each time + sit-to-stand training using the Movi chair 3x/wk for approximately 10 minutes each time.
15971164|NCT03103464|Other|Standard-of-Care Therapy|Standard-of-care physical therapy 3x/wk for approximately 30 minutes each time.
15971165|NCT03103451|Drug|BCD-121|
15971166|NCT03103451|Other|Placebo|
15971167|NCT03103438|Biological|BCD-089|
15971168|NCT03103412|Drug|TD-3504|TD-3504
15971169|NCT03103412|Drug|15N2-tofacitinib|15N2-tofacitinib
15971170|NCT03103412|Drug|Placebo|Placebo
15971171|NCT03103399|Drug|Comtan®|200 mg entacapone were to be taken concomitantly with each levodopa/DDCI dose.
15971172|NCT03103399|Drug|Nebicapone|50 mg, 100 mg and 150 mg doses of nebicapone were to be taken concomitantly with each levodopa/DDCI dose.
15971173|NCT03103399|Drug|Levodopa/DDCI|"Prior to the study, all patients were to have been receiving levodopa/DDCI therapy for at least 1 year with clear clinical improvement. At entry to the study, patients were to be receiving levodopa/DDCI therapy of at least 4 but not more than 8 (inclusive) standard daily doses.
~All patients were to continue receiving levodopa/DDCI during the study. Levodopa and DDCI were prescribed by the investigators and purchased locally by patients."
15971174|NCT03103399|Drug|Placebo|Administered orally as encapsulated tablets, which were identical in appearance to the study drugs
15971175|NCT03103386|Dietary Supplement|intake of food product with a patented fermented rye bran|During the treatment period, participants will be provided 2 packages of puff（fermented rye bran）and 2 packages of crisp bread to be included in the daily diet. Participants are free to consume the product any time during the day to facilitate compliance.
15971176|NCT03103386|Dietary Supplement|intake of food product with common refined wheat|During the treatment period, participants will be provided 2 packages of puff （common refined wheat）and 2 packages of crisp bread to be included in the daily diet. Participants are free to consume the product any time during the day to facilitate compliance.
15971177|NCT03103373|Device|Conventional monitor|Patients underwent non-cardiac surgery will be monitoring by regular monitors
15971178|NCT03103373|Device|Echocardiography|Patients will be monitoring by regular monitors plus echocardiography
15971179|NCT03103360|Device|videopupillometer|Measure of pupillary diameter and pupillary pain index via an infrared camera Each measure lasts approximately 20 seconds
15971180|NCT03103360|Procedure|skin incision|performed under general anesthesia by the surgeon, at the beginning of an elective or emergency surgery.
15971181|NCT03103334|Other|Zeneo® - Methotrexate|0.625 mL of methotrexate solution 40 mg/ML for subcutaneous injection with a prefilled and needle-free delivery system
15971182|NCT03103334|Drug|Methotrexate Biodim®|1 mL of methotrexate solution 25 mg/mL for subcutaneous injection with a conventional needle and syringe injection
15971183|NCT03103321|Other|Internet-Based Intervention|"Receive Knowing your Options decision aid"
15971184|NCT03103321|Other|Internet-Based Intervention|"Receive Prostate Choice decision aid"
15971185|NCT03103321|Other|Best Practice|Undergo usual care
15971186|NCT03103321|Other|Quality-of-Life Assessment|Ancillary studies
15971187|NCT03103321|Other|Questionnaire Administration|Ancillary studies
15971188|NCT03103321|Other|Survey Administration|Ancillary studies
15971189|NCT03103321|Other|Laboratory Biomarker Analysis|Correlative studies
15971190|NCT03103308|Other|Walk Training and Transplant|Subjects will receive free activity monitors and have three training sessions per week for the duration of their bone marrow transplant treatment
15971191|NCT03103308|Other|Activity Monitoring and Transplant|Subjects will receive free activity monitors for the duration of their bone marrow transplant treatment
15971192|NCT03103295|Biological|3D-Tissue Engineered Bone Equivalent|Administrated for operative delivery of 3D-Tissue Engineered Bone Equivalent
15971193|NCT03103282|Device|PuraStat®|Synthetic haemostatic material
15971194|NCT03103269|Behavioral|Challenge! Small Group Intervention|The Challenge! Small Group intervention consists of curriculum related to health behavior goal setting, healthy eating, and staying active, working out with Health Educators, and receiving a year-long membership to the YMCA.
15971195|NCT03103269|Other|Challenge! Environmental Intervention|The environmental intervention involves the formation of a Health and Activity Committee composed of community members, teachers, parents, school staff, and 8th grade girls from the school. Together, this group comes up with ways to make their school environment healthier.
15971196|NCT03103256|Drug|YHP1701|PO, Once daily (QD), 8 weeks
15971197|NCT03103256|Drug|YHR1703|PO, Once daily (QD), 8 weeks
15971198|NCT03103256|Drug|YHR1704|PO, Once daily (QD), 8 weeks
15971199|NCT03103243|Behavioral|Mindfulness Based Group Sessions|In-person group intervention sessions conducted with a combination of meditation, group exercise (yoga), group discussions, deep breathing and other mindfulness based practices.
15971200|NCT03103230|Device|Cortical magnetic stimulation|Motor Evoked Potentials of lips and hand recorded after cortical magnetic stimulation
15971201|NCT03103217|Behavioral|brief CBT for anxious pregnant women|one off 3 hour session including psychoeducation, exploration of cognitions and experiential practice of behavioural techniques.
15971202|NCT03103204|Combination Product|One-stage full-mouth disinfection with chlorhexidine|"Mechanical procedures, composed of full-mouth dental scaling and root planning and dental prophylaxis, will be completed within 24 hours (2 appointments in 2 consecutive mornings or afternoons).
~Chlorhexidine will be used as the antimicrobial agent in different concentrations (0.2%, 1% and 2%) and vehicles (solution, gel).
~Oral hygiene instructions will be given for all participants."
15971203|NCT03103191|Diagnostic Test|KL-6 levels|Measure of KL-6 in serum
15971204|NCT03103178|Other|Quality of life questionnaire|Measurement of quality of life
15971205|NCT03103152|Drug|High dose Aspirin & Vitamin D|Aspirin 1 x 300mg tablet daily & Vitamin D 4,000IU daily. (8 drops).
15971206|NCT03103152|Drug|High dose Aspirin, Vitamin D placebo|Aspirin 1 x 300mg tablet daily & Vitamin D placebo (8 drops).
15971207|NCT03103152|Drug|Low dose Aspirin , Vitamin D|Aspirin 1 x 100mg tablet daily & Vitamin D 4,000IU daily. (8 drops).
15971208|NCT03103152|Drug|Low dose Aspirin, Vitamin D placebo|Aspirin 1 x 100mg tablet daily & Vitamin D placebo 8 drops daily.
15971209|NCT03103152|Drug|Aspirin Placebo, Vitamin D|Aspirin 1 x 300mg placebo tablet daily & Vitamin D 4,000IU daily. (8 drops).
15971210|NCT03103152|Drug|Aspirin placebo, Vitamin D placebo|Aspirin 1 x 100mg placebo tablet daily & Vitamin D 4,000IU daily. (8 drops).
15971211|NCT03103139|Procedure|Transpapillary Stent|ERCP with placement of short stent
15971212|NCT03103139|Procedure|Stent across bile leak|ERCP with long stent
15971213|NCT03103126|Behavioral|Combined resistance exercise and walking|Combined resistance exercise and walking
15971214|NCT03103100|Drug|1% Lidocaine|10 mL of 1% lidocaine
15971215|NCT03103100|Drug|0.25% Bupivacaine|10 mL of 0.25% bupivacaine
15971216|NCT03103100|Drug|Bupivacaine plus Lidocaine|5 mL of 1% lidocaine and 5 mL of 0.25% bupivacaine
15971217|NCT03103087|Drug|Relugolix|Relugolix (40 mg) tablet administered orally once daily.
15971218|NCT03103087|Drug|Estradiol/norethindrone acetate|E2 (1.0 mg)/NETA (0.5 mg) co-formulated capsule administered orally once daily.
15971219|NCT03103087|Drug|Relugolix placebo|Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.
15971220|NCT03103087|Drug|Estradiol/norethindrone acetate placebo|E2 (0 mg)/NETA (0 mg) placebo capsule administered orally once daily and designed to match the capsule containing E2/NETA in size, shape, color, and odor.
15971221|NCT03103074|Drug|Botulinum B Toxin|Intradermal injections
15971222|NCT03103074|Other|Placebo Saline|Intradermal injections
15971223|NCT03103061|Drug|Lexiscan|Coronary vasodilator
15971224|NCT03103048|Diagnostic Test|Without bandages|All volunteers will be held the grasping force measurements without application of elastic adhesive bandage or micropore
15971225|NCT03103048|Diagnostic Test|With placebo|All volunteers will be held the grasping force measurements with application of micropore (placebo) on his forearm in both upper members
15971226|NCT03103048|Diagnostic Test|With bandage|All volunteers will be held the grasping force measurements with application of bandage without tension in the forearm in both upper members
15971227|NCT03103048|Diagnostic Test|With tensioned bandage|All volunteers will be held the grasping force measurements with application of bandage with twenty five percent tensioned on the forearm in both upper members
15971228|NCT03103035|Other|Blog|Participants randomised to the experimental group are exposed to one blog post each week for a period of 6 months. Blog posts focus on the improvement of fruits and vegetables consumption targeting four main determinants of the behavior: (1) knowledge; (2) attitude; (3) self-efficacy; and (4) motivation/goals. Each post included a step-by-step recipe developed by the research team and featuring fruits and vegetables. Recipes were described textually and also using pictures and/or video. Twenty-six posts were created over the six-month intervention.
15971229|NCT03103022|Drug|Acetaminophen|Oral acetaminophen [160 mg/5ml concentration] will be administered every 6 hours with dose of 15 mg/kg/dose for a total of twelve doses
15971230|NCT03103022|Drug|ibuprofen|Oral ibuprofen [100 mg/5 ml] at 10 mg/kg/dose on first day followed by 5 mg/kg/dose at 24 and 48 hours for a total of three doses
15971269|NCT03102723|Drug|Cangrelor|"Cangrelor treatment: IV Cangrelor as a single IV bolus (30 μg/kg) followed by an infusion (4 μg/kg/min) of at least 120 minutes duration or until PPCI procedure has ended (whichever is longer) - this will be initiated prior to PPCI. This dosing regimen is identical to that used in the CHAMPION trials.
~Or
~Placebo control: IV normal saline as a single IV bolus followed by an infusion of at least 120 minutes duration or until PPCI procedure has ended (whichever is longer) - this will be initiated prior to PPCI."
15971507|NCT03100942|Drug|Filgotinib|1 x 200 mg tablet administered orally once daily
15971231|NCT03103009|Drug|Pasireotide|Somatostatin analogues are a last resort for medical intervention in hyperinsulinemic hypoglycemia (HH). The hypoglycemia is very debilitating and can be even life threatening. There is limited experience with pasireotide in hyperinsulinemic hypoglycemia (only one publication); there is more experience with octreotide, both in adults and children and successful interventions with octreotide in hyperinsulinemic hypoglycemia have been published. Pasireotide via its different somatostatin receptor binding profile has clear effects on insulin, glucagon and incretin secretion and can ultimately lead to hyperglycemia. This mode of action (especially the effects on insulin and incretin secretion) could be very useful in the setting of hyperinsulinemic hypoglycemia.
15971232|NCT03102996|Drug|Nephrotrans|Sodium hydrogen carbonate, ATC-Code: A02AH
15971233|NCT03102996|Other|Placebo|Identical capsules without active substance.
15971234|NCT03102983|Other|MRI functional|vowels records and MRI session
15971235|NCT03102957|Other|functional MRI|
15971236|NCT03102944|Diagnostic Test|Minicare BNP|no real intervention since only leftover materials are used from volunteers and samples are not tested on Minicare BNP IVD device near any volunteer.
15971237|NCT03102931|Other|Reduced ROS/RNS content products|Participants will be given and asked to spoke only the cigarettes provided for them. Biosamples and surveys will be collected every 2 weeks throughout the study.
15971238|NCT03102931|Other|Typical to high (ROS/NOS) products|Participants will be given and asked to spoke only the cigarettes provided for them. Biosamples and surveys will be collected every 2 weeks throughout the study.
15971239|NCT03102918|Drug|Cannabidiol|Participants will receive either up to 800 mg Epidiolex over a 6-week treatment period.
15971240|NCT03102918|Drug|Placebo|Participants will receive placebo over a 6-week treatment period.
15971241|NCT03102905|Other|Measurement of the prevalence of the positivity of cutaneous HHV6 quantitative PCR in the cohort studied.|To evaluate the prevalence of the positivity of HHV6 PCR in the skin, during the exanthema in patients hospitalized for haemopathy.
15971242|NCT03102892|Procedure|Scaling root planing|Treatment by scaling and root planing alone.
15971243|NCT03102892|Procedure|Antimicrobial photodynamic therapy|Treatment with methylene blue dye and red laser
15971244|NCT03102879|Procedure|Regenerative Endodontic Procedure|Coronary access, conductometry, mechanized instrumentation, irrigation with sodium hypochlorite, intracanal calcium hydroxide medication and obturation with stem cells.
15971245|NCT03102879|Procedure|Conventional Root Canal Treatment|Coronary access, conductometry, mechanized instrumentation, irrigation with sodium hypochlorite, intracanal calcium hydroxide medication and obturation with gutta-percha.
15971246|NCT03102866|Other|Best Practice|Receive usual care
15971247|NCT03102866|Behavioral|Exercise Intervention|Undergo aerobic and strength training exercise
15971248|NCT03102866|Other|Quality-of-Life Assessment|Ancillary studies
15971249|NCT03102866|Other|Questionnaire Administration|Ancillary studies
15971250|NCT03102853|Other|Nordic diet|
15971251|NCT03102853|Other|Control diet|
15971252|NCT03102840|Diagnostic Test|Nasopharyngeal swab|Nasopharyngeal swab will be performed in all participants
15971253|NCT03102840|Diagnostic Test|blood sampling|Blood sampling will be done by finger-prick in a sub-set of participants
15971254|NCT03102827|Drug|Oxygen|Patients will receive oxygen with humidified air, fully saturated at 37° C at a flow rate of 20- 50 L/min. The ratio of oxygen and ambient air (FiO2) will be increased stepwise depending on patient's oxygen saturation.
15971255|NCT03102827|Other|Placebo|Ambient air without high-flow therapy administered during first night
15971256|NCT03102814|Behavioral|Current rehabilitation|The control group will receive the rehabilitation currently offered at each of the participating centers.
15971257|NCT03102814|Behavioral|The BRIDGE program|The experimental group will additionally receive the BRIDGE program, which comprises motivational interviewing, structured goal-setting, tailored follow-up, plans for self-management, and individualised written feedback that participants can use to monitor their progress and share with important care givers.
15971258|NCT03102801|Drug|Humulin S|Humulin S used to induce hypoglycaemia
15971259|NCT03102788|Behavioral|Rheumatologist-led care.|"Rheumatologist-led care comprises confirmation of diagnosis, information about hand osteoarthritis and symptom modifying medication, and, for some patients, Intra-articular injection of long-acting Corticosteroid.
~The rheumatologist may also refer participants to occupational therapy if needed."
15971260|NCT03102788|Behavioral|Occupational therapist-led care.|Occupational therapist-led care comprises confirmation of diagnosis, information about hand osteoarthritis and symptom modifying medication, teaching of hand exercises and ergonomic working methods, and, for some patients, provision assistive devices and orthoses/splints. The occupational therapist will refer patients to a short rheumatologist consultation if confirmation of diagnosis or intra-articular injections of long-acting Corticosteroid are needed.
15971261|NCT03102775|Other|Comprehensive follow-up program for low-income families|The main follow-up areas within the HOLF-program is to improve employment, housing, financial situation of the children. Beside manuals, family coordinators participate in five seminars with home-based tasks in between. Alo a comprehensive supervision structure is implemented that follow the train the trainer model. Coordinators ought to work directly with th families, but also with other actors important to the family, such as child-welfare and school. Coordinators should use specific tools improving the quality of the meetings, such as forms for preparation of meetings, being goal-focused and empowering.
15971262|NCT03102775|Other|local family projects|The control group offices will develop local family projects, depending on local needs. they will also recruit and follow-up families.
15971263|NCT03102762|Drug|Botulinum Toxin Type A|Drug: Botulinum Toxin Type A The treatment group will be injected with 100 units BTX-A one day following penile colour doppler assessment.
15971264|NCT03102762|Drug|Normal saline|The treatment group will be injected with 1 ml normal saline one day following penile colour doppler assessment.
15971265|NCT03102749|Other|metacholine provocation test and CT-scan low dose|Investigators perform a metacholine provocation test where expiratory CT slices were acquired at each dose
15971266|NCT03102736|Drug|Placebos|Placebo saline
15971267|NCT03102736|Drug|Ketamine|0.5 mg/kg ketamine
15971268|NCT03102736|Drug|Nitroprusside|0.5 mcg/kg nitroprusside
15971508|NCT03100942|Drug|Tirabrutinib|1 x 40 mg tablet administered orally once daily
15971270|NCT03102710|Device|transcranial direct current stimulation (tDCS)|tCDS safely applies a weak electrical current to your scalp using two sponge electrodes that look like flat circular pads. The pads will be held in place on your head with a neoprene cap. The pads will be attached to a generator that will send a weak stimulus to your scalp. This current influences the way that your brain cells work. When the stimulus starts, you might feel a tingling sensation underneath the electrode pads. That sensation is not painful and goes away in seconds.
15971271|NCT03102710|Other|Lidocaine cream|Lidocaine cream will be applied on the arm to reduce pain sensitivity (analgesia).
15971272|NCT03102710|Other|Capsaicin cream|Capsaicin cream will be applied on the arm to increase pain sensitivity (hyperalgesia).
15971273|NCT03102710|Other|Control cream|A neutral cream will be applied on the arm as a control.
15971274|NCT03102697|Device|Air-filled Intragastric balloon|Weight loss system that consists of an air balloon that occupies space in the stomach, thus reducing the gastric capacity and leaving less volume for food.
15971275|NCT03102684|Other|Secondhand exposure to e-cigarette aerosols (low)|"Participants will be exposed to secondhand aerosols produced by e-cigarette use. E-cigarette with low resistance will be used by an experienced smoker (tobacco flavor liquid, 12 mg nicotine, 4 sec puffs, 20-30 seconds inter-puff interval). Duration of exposure: 30 minutes.
~All study subjects will participate in this arm as the study has a cross-over design."
15971276|NCT03102684|Other|Secondhand exposure to e-cigarette aerosols (high)|"Participants will be exposed to secondhand aerosols produced by e-cigarette use. E-cigarette with high resistance will be used by an experienced smoker (tobacco flavor liquid, 12 mg nicotine, 4 sec puffs, 20-30 seconds inter-puff interval). Duration of exposure: 30 minutes.
~All study subjects will participate in this arm as the study has a cross-over design."
15971277|NCT03102671|Other|Use of HeartHab application followed by usual care|use of a mobile, app based multidisciplinary telerehabilitation program (2 months) followed by usual care (two months)
15971278|NCT03102671|Other|Usual care followed by the use of HeartHab application|Usual care (2 months) followed by the use of HeartHab application (two months)
15971279|NCT03102658|Drug|Micafungin|Administration of study drug
15971280|NCT03102645|Drug|Placebo Oral Tablet|Placebo film coated tablet: Lactose monohydrate, potato starch, gelatine, magnesium stearate, talc
15971281|NCT03102645|Drug|Imipramine Hydrochloride 25 MG|Two Imipramin DAK film coated tablets 25 mg each, single dose
15971282|NCT03102632|Other|High Water Intake|After 6 months of usual, unchanged diet and fluid intake, participants will be asked to increase the daily fluid intake based on the principal investigator's prescription. The actual amount of extra water prescribed will depend on the results of the participant's 24 hour urine test.
15971283|NCT03102606|Drug|Plinabulin|Plinabulin (BPI-2358) is a synthetic, low molecular weight, new chemical entity that belongs to the diketopiperazine class of compounds. Plinabulin is intended for intravenous (IV) infusion and is diluted in D5W and administered for 30 minutes (± 5 minutes).
15971284|NCT03102606|Drug|Pegfilgrastim|PEGFILGRASTIM is a long-acting granulocyte colony-stimulating factor that stimulates the growth of neutrophils, to reduce the incidence of fever and infection in patients with certain types of cancer who are receiving chemotherapy that affects the bone marrow.
15971285|NCT03102606|Other|Saline Placebo|Placebo Syringe 0.6 ml Saline to match the 0.6 ml pegfilgrastim administration
15971286|NCT03102606|Other|D5W Placebo|Placebo 250 ml D5W to match the administration of plinabulin diluted in 250 ml D5W
15971287|NCT03102593|Drug|ARGX-113|ARGX-113 (Dose A or Dose B) or matching placebo will be administered IV weekly
15971288|NCT03102593|Other|Placebo|ARGX-113 (Dose A or Dose B) or matching placebo will be administered IV weekly
15971289|NCT03102580|Other|OA Care Plan|Patient and surgeon will receive the OA Care Plan (currently under development). This Care Plan will inform Shared Decision for treatment of moderate to sever OA, including surgical and non-surgical options.
15971290|NCT03102567|Drug|GLPG1205 50mg q.d.|oral gelatin capsule containing 50mg GLPG1205 for q.d. administration - compared to placebo
15971291|NCT03102567|Drug|Placebo oral capsule|oral gelatin capsule containing placebo to match study arm 1 - q.d. administration
15971292|NCT03102567|Drug|GLPG1205 250 loading dose and 50mg q.d. maintenance dose|Open label - oral gelatin capsule containing 50mg GLPG1205 for one time 250mg loading dose and subsequent q.d. administration
15971293|NCT03102554|Genetic|Return of Genetic Results|The results of testing for genetic causes of DSD/hypospadias will be returned to parents of subjects who elect to receive these results.
15971294|NCT03102541|Other|None intervention|
15971295|NCT03102528|Other|No intervention|No intervention
15971296|NCT03102515|Drug|USG-TAP block|
15971297|NCT03102515|Drug|CIC|
15971298|NCT03102502|Device|EECP|Enhanced external counterpulsation (EECP) is a technique for assisting the circulation by decreasing the afterload of the left ventricle and augmenting the diastolic pressure externally by applying a negative pressure to the lower extremities during cardiac systole. EECP therapy is done by sequential inflation of 3 sets of cuffs wrapped around the lower extremities during diastole and deflation of the cuffs during systole. EECP enhances the aortic diastolic blood flow and coronary perfusion, leading to increased arterial wall shear stress in a pulsatile manner.
15971299|NCT03102502|Drug|Medical therapy|Guideline- driven standard medical treatment including statins,antiplatelet drugs（aspirin or Clopidogrel ）, anti-ischemic drugs （Nitroglycerin）
15971300|NCT03102489|Drug|BP101|Nasal spray
15971301|NCT03102489|Drug|Placebo|Nasal spray
15971302|NCT03102476|Drug|Humalog|Subcutaneous injection of Humalog and assessing Pharmacokinetics and Pharmacodynamics properties of Humalog under different environmental conditions
15971303|NCT03102463|Dietary Supplement|Water Control|120mL water given as a control, followed by a hyperinsulinemic-euglycaemic clamp
15971304|NCT03102463|Dietary Supplement|Milk derived hydrolysate|Milk derived hydrolysate made up as a milkshake in 120mL water, followed by a hyperinsulinemic-euglycaemic clamp
15971305|NCT03102463|Dietary Supplement|Parent Protein|Parent protein made up as a milkshake in 120mL water, followed by a hyperinsulinemic-euglycaemic clamp
15971306|NCT03102463|Other|Lipid Load|100mL oral lipid load
15971477|NCT03101111|Biological|MV-CHIK|Lyophilized, life attenuated, measles vectored Chikungunya vaccine; 5E+05 TCID50 (+/- 0.5 log) per dose
15971509|NCT03100942|Drug|Lanraplenib placebo|1 x tablet administered orally once daily
15971307|NCT03102450|Drug|Benzalkonium Chloride Spermicide Cream|"One dose of Pharmatex vaginal cream (benzalkonium chloride) must be used systematically before each intercourse, regardless of the cycle period, even during menstrual periods. In case of repeated acts of intercourse, an additional dose of cream must be used before each new act.
~Duration of treatment : 6 months (12 months optional)"
15971308|NCT03102437|Device|Optimizer Smart System|The Optimizer Smart System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day.
15971309|NCT03102424|Device|Transcutaneous Electrical Nerve Stimulator (DW1330)|The 20 weeks of treatment of the DW1330 device, all the patients enrolled should perform 1 treatment within 1 hour after dinner 5 days a week.
15971310|NCT03102424|Device|Sham DW1330 device|The Sham DW1330 device will be masked by the same appearance as the study device (DW1330). The usage of time and location of Sham DW1330 device will be completely the same with study device (DW1330). However, the electronic model, including the frequency and time consistence of electronic stimulation are different between the Sham DW1330 device and the study device (DW1330). The 20 weeks of treatment of the DW1330 device, all the patients enrolled should perform 1 treatment within 1 hour after dinner 5 days a week.
15971311|NCT03102398|Drug|TR-399 (5% Vardenafil HCl·3H2O, topical gel)|5% Vardenafil HCl·3H2O, topical gel, 2 drops (50ul, 2.5mg), q.d.
15971312|NCT03102385|Behavioral|Motivational Interview|A web-based computer-tailored intervention that includes open-ended questions, reflective responses, affirmations, and summarizing, as well as informing and advising. Specific topics include 1) individual motivations for giving, 2) the relationship between past donation behavior and the individual's personal goals/values, 3) donation importance and confidence rulers, 4) addressing donor concerns, and 5) summarizing.
15971313|NCT03102385|Behavioral|Knowledge Interview|A web-based interview that includes open-ended questions regarding blood donation knowledge.
15971314|NCT03102372|Dietary Supplement|Whey protein supplementation|
15971315|NCT03102372|Other|walking program|
15971316|NCT03102372|Other|Very Low Calorie Diet|
15971317|NCT03102359|Drug|Dexmedetomidine|Using dexmedetomidine at anesthesia induction and maintain until the end of the surgery
15971318|NCT03102359|Device|Cooling Helmet|Using cooling helmet for selective head cooling group and Selective Head Cooling and Dexmedetomidine group
15971319|NCT03102346|Other|home-based cardiac rehabilitation|The exercise training includes aerobic exercise (fast walking or cycling ,30-40 minutes per day,5-6 times a week), stretching exercise (15 minutes every time, 5-6 times a week), and resistance and balance training (each of 15 minutes every time, twice to 3 times a week).
15971320|NCT03102333|Device|Variable-rate Feedback Infusion mode|The PCA regimen consisted of fentanyl 20 μg/kg and Ramosetron Hcl 0.3 mg (total volume including saline: 100 ml) and was programmed to deliver 1 ml /h as a background infusion and a bolus of 1.5 ml on-demand, with a 15 min lockout time. It can increment or decrement rate(0.2ml/hr) by press bolus button during a 48 h period
15971321|NCT03102333|Device|Constant-rate Infusion mode|The PCA regimen consisted of fentanyl 20 μg/kg and Ramosetron Hcl 0.3 mg (total volume including saline: 100 ml) and was programmed to deliver 1 ml /h as a background infusion and a bolus of 1.5 ml on-demand, with a 15 min lockout time during a 48 h period
15971322|NCT03102320|Drug|Cisplatin|Cisplatin 25 mg/m2 IV administered on day 1 and day 8 of 21 day cycle, for up to maximum 6 cycles
15971323|NCT03102320|Drug|Gemcitabine|Gemcitabine 1000 mg/m2 IV administered on days 1 and 8 of a 21-day cycle
15971324|NCT03102320|Drug|Anetumab ravtansine (BAY94-9343)|Anetumab ravtansine 6.5mg/kg IV in monotherapy indications. For combination indications, the MTD determined in safety lead in phase will be administered
15971325|NCT03102307|Other|Not suitable for TAD|Registry of the rate of patients not suitable for TAD as initial CNB with clip placement of axillary lymph nodes is not possible and underlying medical contraindications, technical obstacles or miscellaneous reasons why needle biopsy and/or clip labeling of clinically affected lymph nodes cannot be done
15971326|NCT03102307|Procedure|Suitable for TAD|Registry of surgical outcome measures of targeted resection of the clipped node with optional sentinel node biopsy or axillary lymph node dissection with or without preceding neoadjuvant chemotherapy
15971327|NCT03102294|Other|inspiratory muscle training|inspiratory muscle training with 50% of MIP
15971328|NCT03102294|Other|"Placebo training"|placebo training with PowerBreathe (without inspiratory load)
15971329|NCT03102255|Procedure|Sniffing position|All procedure is done under sniffing position.
15971330|NCT03102255|Procedure|Nasal tip lifting|Before inserting the endotracheal tube to patient's nose, the researcher lift up the nose tip.
15971331|NCT03102242|Drug|Atezolizumab|Single arm phase II trial of induction immunotherapy with anti-PD-L1 for patients with unresectable stage III NSCLC and PS 0-1.
15971332|NCT03102229|Other|Enhanced Supportive Care - Status Checks|Would occur everyday during treatment when a patient is deemed high-risk.
15971333|NCT03102229|Other|Enhanced Supportive Care - Referrals|On an as-need basis, high risk patients can be referred to our nutritionist or palliative care doctor.
15971334|NCT03102216|Diagnostic Test|iSTAT|iSTAT troponin, INR, CG4+ and Chem8
15971335|NCT03102216|Diagnostic Test|CBC|Complete Blood Count
15971336|NCT03102216|Diagnostic Test|ECG|ElectroCardioGram
15971337|NCT03102216|Diagnostic Test|Lodox|Low dose x-ray
15971338|NCT03102190|Drug|Verapamil Hydrochloride Intranasal|Verapamil solution for injection, supplied in vials, will be utilized in a Neil Med Sinus Rinse of 240mL buffered normal saline.
15971339|NCT03102177|Drug|Administration of stable Isotope labeled levothyroxine|Administration of single dose of stable isotope carbon-13 labeled levothyroxine and measurement of blood levels of stable isotope-labeled levothyroxine
15971340|NCT03102164|Procedure|cardiac rehabilitation|The rehabilitation protocol comprises respiratory, assisted, active dynamic, and relaxation exercises, as well as short-term isometric exercises and general strength exercises of very low intensity, short duration and properly adjusted recovery phase; they are conducted in a lying, sitting, or standing position.
15971341|NCT03102151|Other|Community Campaign La CLAVE|A community campaign to teach community residents and professional networks the signs and symptoms of psychosis using social media, community talks, and advertising.
15971342|NCT03102125|Drug|Regadenoson|For use in stress myocardial perfusion imaging.
15971343|NCT03102112|Other|MRI examination|A noninvasive medical diagnostic technique in which the absorption and transmission of high-frequency radio waves are analysed as they irradiate the hydrogen atoms in water molecules and other tissue components placed in a strong magnetic field. This computerized analysis provides a powerful aid to the diagnosis and treatment planning of many diseases, including cancer.
15971344|NCT03102099|Procedure|contrast-enhanced ultrasound group|The contrast-enhanced ultrasound patients will undergo biopsy with contrast-enhanced ultrasound guidance.
15971345|NCT03102099|Procedure|conventional ultrasound group|The conventional ultrasound group will undergo biopsy with conventional ultrasound guidance.
15971346|NCT03102086|Procedure|Scaling|Scaling of dental calculus
15971347|NCT03102073|Diagnostic Test|Radner test|"The A5 reading booklet is held by the subject
~The subject is instructed to read sentence by sentence, by turning consecutively the pages of the booklet (on the first side is the number of sentence and the backward side contains the sentence)
~The subject is instructed to read the sentences aloud as quickly and accurately as possible to the end, and to not correct reading errors.
~One assessor is writing the reading time and records any reading errors on the scoring sheet while the second assessor is audio recording the operation
~Stop criterion: reading time longer than 20 seconds or severe errors."
15971348|NCT03102060|Other|Dietary Intervention|Undergo gluten free diet
15971349|NCT03102060|Other|Laboratory Biomarker Analysis|Correlative studies
15971350|NCT03102047|Drug|durvalumab|Within 3-7 days after completion of chemoradiation, patients will receive durvalumab (750 mg IV infusion) every 2 weeks for 4 doses on Day 1(Dose 1), Day 15 (Dose 2), Day 29 (Dose 3), and Day 43 (Dose 4)
15971351|NCT03102034|Biological|D46/NS2/N/ΔM2-2-HindIII|10^5 plaque-forming units (PFU) per 0.5ml vaccine; administered as nose drops
15971352|NCT03102034|Biological|Placebo|Isotonic diluent; administered as nose drops
15971353|NCT03102021|Drug|erythropoietin|500 units/kg daily for 3 days at onset of acute kidney injury
15971354|NCT03102021|Drug|saline|saline 10 ml for 3 days
15971355|NCT03102008|Behavioral|Unified Protocol for Emotional Disorders in Adolescents (UP-A)|The Unified Protocol for Emotional Disorders in Adolescents (UP-A), is a transdiagnostic therapeutic intervention employing core dysfunction approaches, defined as such due to their attendance to features of various (emotional) disorders. The treatment may work to ameliorate symptoms more broadly by targeting cross-cutting features common to the range of disorders targeted. Specifically, the UP-A might lead to the successful treatment of an array of emotional disorders in youth by targeting processes common across these frequently co-occurring problems including poor distress tolerance, limited cognitive flexibility, and heightened avoidance.
15971356|NCT03101995|Drug|Gemcitabine|"Gemcitabine 300 mg/m2, prepared in 0.5 liters of sodium chloride 0.9%, IV administered in 30 minutes weekly for a maximum of 6 weeks.
~Radiotherapy will start the first week, or as soon as the blood count is normal or the patient has recovered after blood transfusion. Radiotherapy will be applied, using an external beam releasing 40-50.4 Gy in 20-28 fractions: 1.8 Gy/day for 5 days/week, during 4 to 6 weeks.
~Intracavitary brachytherapy will be added to reach a total EQD2 dosage (α/β=10) of 78-86 Gy."
15971357|NCT03101982|Drug|HBO|Hyperbaric oxygenation (HBO) is defined as breathing of 100% oxygen under elevated ambient pressure in a hyperbaric chamber. HBO is considered a pharmacological therapy.
15971358|NCT03101969|Other|Call|not called, not reached, and spoken to
15971359|NCT03101956|Procedure|Lumbar Spine Manipulation|• The subject will be placed in sidelying on a treatment table. Facing the subject, the therapist will position the subject's superior thigh in flexion and rotate the subject's upper trunk to the opposite side. The therapist will place his cephalad forearm along the subject's superior lateral trunk and the caudal forearm along the subject's iliac crest and lateral hip. Lastly, the therapist will roll the subject towards himself or herself.
15971360|NCT03101956|Procedure|Lumbar Spine Manipulation Placebo|The subject will be placed in sidelying on a treatment table. Facing the subject, the therapist will position both hips and knees in approximately 45° of flexion. The therapist will place his or her cephalad forearm along the subject's superior lateral trunk and the caudal forearm along the subject's iliac crest and lateral hip. Lastly, the therapist will roll the subject towards himself or herself.
15971361|NCT03101943|Behavioral|Family Spirit Nurture (FSN)|The FSN intervention will be conducted over a 6-month period. Participants in the intervention group will receive 6- 45 minute lessons in their home or a private place of their choosing. The lessons focus on elimination or reduction of Sugar Sweetened Beverages (SSBs) among infants while teaching mothers complementary feeding and responsive parenting practices
15971362|NCT03101943|Other|Control Program|The control group will receive three home-based lessons with home safety information.Lessons will be delivered monthly (at 3, 4 and 5 months postpartum) in the same format as the FSN lessons, by trained FHCs in the home of the participant or in a private place of their choosing.
15971363|NCT03101943|Other|Water Delivery|Drinking water will be delivered to the household of each participant (both in the FSN intervention and control groups) from 6 to 9 months postpartum. The amount of water will be determined by the number of children and adults living in the household at the time of water delivery. The first delivery of water will occur at the time of the 6-month evaluation and the last delivery will occur at the time of the 9-month evaluation. Water will be delivered as often as weekly. Those families who do not need weekly water delivery (based on their preference and their usage of the first delivery of water) will receive water less frequently.
15971364|NCT03101930|Drug|Liraglutide|subcutaneous liraglutide daily
15971365|NCT03101930|Drug|Sitagliptin|oral sitagliptin daily
15971366|NCT03101930|Other|hypocaloric diet|Reduced calorie intake to achieve weight loss.
15971367|NCT03101930|Drug|Placebos|Subjects in the liraglutide arm will receive a placebo for sitagliptin. Those in the sitagliptin arm will receive a placebo for liraglutide. All subjects will receive a placebo for Exendin 9-39.
15971368|NCT03101930|Drug|Exendin (9-39)|All subjects will receive Exendin (9-39) or matching placebo in crossover fashion during study days on the first and third days of the second week after randomization and again on the 5th and 7th days of the 14th week of treatment.
15971369|NCT03101917|Device|The Microtable® Stereotactic System|x
15971370|NCT03101904|Dietary Supplement|Beetroot Juice|
15971371|NCT03101904|Dietary Supplement|Placebo|
15971478|NCT03101111|Biological|MMR-vaccine|Lyophilized mixture of life attenuated Measles, Mumps, and Rubella viruses; 1000, 12500, and 1000, respectively, TCID50 per dose
15971372|NCT03101891|Procedure|Serial amnioinfusions with isotonic fluid|Amnioinfusions will be performed by an expert in fetal procedures with a 20 or 22 gauge needle using sterile technique and ultrasound guidance. Local anesthetic will be employed. The fluid will consist of warmed isotonic fluid. Infusions may take up to 1 hour.
15971373|NCT03101891|Device|Spinal needle|A 20 or 22 gauge spinal needle will be used with sterile technique to access the uterus under ultrasound guidance and to infuse isotonic fluid.
15971374|NCT03101891|Drug|Isotonic fluid|Isotonic fluids, including normal saline or lactated ringers solution, will be infused into the uterus through a spinal needle under ultrasound guidance using sterile technique. This fluid will act as replacement amniotic fluid.
15971375|NCT03101878|Drug|Ionis AGT-LRx|Ascending single and multiple doses of Ionis AGT-LRx administered subcutaneously
15971376|NCT03101878|Drug|Placebo|Saline .9%
15971377|NCT03101865|Device|FlorenceM|The automated closed loop system (FlorenceM) will consist of: Next generation sensor augmented Medtronic insulin pump 640G (Medtronic Minimed, CA, USA) incorporating the Medtronic Enlite 3 family real time CGM and glucose suspend feature. An Android smartphone containing the Cambridge model predictive algorithm and communicating wirelessly with the insulin pump using a proprietary translator device.
15971378|NCT03101852|Dietary Supplement|Plumpy Nut|
15971379|NCT03101852|Dietary Supplement|Plumpy Sup|
15971380|NCT03101839|Drug|AZD4785|KRAS Antisense Oligonucleotide
15971381|NCT03101826|Behavioral|Listening Project Protocol|The filtered music intervention will consist of listening to computer-altered acoustic stimulation, designed to modulate the frequency band of vocal music passed to the participant. The frequency characteristics of the acoustic stimulation are selected to emphasize the relative importance of specific frequencies in conveying the information embedded in human speech Modulation of the acoustic energy within the frequencies of human voice, similar to an exaggerated vocal prosody, are hypothesized to recruit and modulate the neural regulation of the middle ear muscles and to functionally reduce sound hypersensitivities and improve auditory processing.
15971382|NCT03101800|Drug|Azathioprine and Allopurinol|Low dose Azathioprine in combination with allopurinol 100 mg for 1 year
15971383|NCT03101800|Drug|Azathioprine|Standard weight based azathioprine dosage
15971384|NCT03101787|Procedure|Extracorporeal cardiopulmonary resuscitation (ECPR)|"In addition to the routine response team, the ECLS team are called to the ED while the patient is transported to the hospital.
~The team consists of a physician skilled and qualified in femoral cannulation, a perfusionist and a scrub nurse.
~Upon the patient's arrival at the emergency department, CPR will be continued, with continuation of mechanical chest compressions with minimization of interruptions.
~Time from arrest to start of cannulation is < 60 minutes."
15971385|NCT03101774|Device|Threshold inspiratory muscle training|Threshold inspiratory muscle training device (Threshold Inspiration Muscle Trainer, Respironics Inc; Pittsburgh, Pennsylvania, USA). The intensiy of IMT was adjusted and verification using Pm measurement in laboratory. Patients spontaneously breathed using resistive-IMT and their Pm were measured simultaneously. Adjusted the intensity of resistive-IMT from small to large according to the Pm waveform. Adjustment completed while mean Pm achieved 60% of MIP and maintained at least 15 minute. Likewise, eligible patients in these group used the resistive IMT device for 15 minutes, twice per day, with an inspiratory load at 60% of PImax as previously adjustment. Training loads were adjusted to maintain 60% of the PImax every week.
15971386|NCT03101774|Device|Resistive inspiratory muscle training|Resistive inspiratory muscle training device(PFLEX, Respironics Inc; Pittsburgh, Pennsylvania, USA). The intensiy of IMT was adjusted and verification using Pm measurement in laboratory. Patients spontaneously breathed using resistive-IMT and their Pm were measured simultaneously. Adjusted the intensity of resistive-IMT from small to large according to the Pm waveform. Adjustment completed while mean Pm achieved 60% of MIP and maintained at least 15 minute. Likewise, eligible patients in these group used the resistive IMT device for 15 minutes, twice per day, with an inspiratory load at 60% of PImax as previously adjustment. Training loads were adjusted to maintain 60% of the PImax every week.
15971387|NCT03101774|Other|Control group|Conventional therapy without any inspiratory muscle training program
15971388|NCT03101748|Drug|Cyclophosphamide|Given IV
15971389|NCT03101748|Drug|Doxorubicin|Given IV
15971390|NCT03101748|Other|Laboratory Biomarker Analysis|Correlative studies
15971391|NCT03101748|Drug|Neratinib|Given PO
15971392|NCT03101748|Drug|Paclitaxel|Given IV
15971393|NCT03101748|Biological|Pertuzumab|Given IV
15971394|NCT03101748|Biological|Trastuzumab|Given IV
15971395|NCT03101735|Drug|Dimethyl Fumarate (DMF)|The non-interventional design allows the observation of patients in a broad range of settings reflecting routine clinical practice. All decisions on therapeutic or diagnostic procedures, treatments, management of the disease, or resource utilisation will be at the full discretion of the treating physician without interference by a sponsor or study protocol. All treatment decisions will follow the real-life treatment behaviour.
15971396|NCT03101722|Drug|BTHE and Huperzine A|huperzine A intervention
15971397|NCT03101722|Other|BETH|basic treatment and health education
15971398|NCT03101709|Drug|Cyclophosphamide|patients will receive a standard pre-conditioning regime with cyclophosphamide 0.8-1.0g/m2/day IV for 2 days(Day-5 to day-4).
15971399|NCT03101709|Drug|Fludarabine|Fludarabine 25 mg/m2/day IV for 3 days (Day-5 to day-3).
15971400|NCT03101709|Biological|CART-19|CART-19 cells will be administered using a split dose on day0(10%), 1(30%), and 2(60%) after completion of the chemotherapy.
15971401|NCT03101683|Radiation|Partial chest wall radiation therapy|A dose of 40 Gy in 16 fractions (2.5 Gy per fraction) is delivered in the area at risk of local recurrence (skin and the pectoralis muscles) delineated by surgical clips and 3D-MRI reconstruction for a precise localization of the tumor excised
15971402|NCT03101670|Drug|filgotinib|one filgotinib oral tablet q.d.
15971403|NCT03101670|Drug|Placebo Oral Tablet|one placebo oral tablet q.d.
15971404|NCT03101644|Drug|Darunavir|The investigated drugs are Prezista (darunavir 600 mg twice-daily or 800 mg once-daily) and Rezolsta (darunavir 800 mg/cobicistat 150 mg once-daily)
15971479|NCT03101098|Procedure|Retroperitoneal liagation of uterine artery|the site of ligation of uterine artery is the area that it originates from the internal iliac artery during TLH
15971480|NCT03101098|Procedure|Classical ligation of uterine artery|the site of ligation of uterine artery is the area alongside the cervix
15971405|NCT03101631|Diagnostic Test|Comprehensive Geriatric Assessment (CGA)|"CGA includes a set of evaluations to determine therapeutic decision based on mortality risk, toxicity risk and frailty group. Evaluations includes:
~Nutritional Assessment: Mini Nutritional Assessment (MNA)
~Functional Assessment: Get up and Go, Activities of Daily Living (ADL), Instrumental Activities of Daily Living (IADL), Karnofsky Scale, Walking one Block, Number of Falls in last 6 months and Hearing Loss.
~Cognitive Assessment: Mini-Mental State Examination (MMSE-30)
~Psychological status: Geriatric Depression Scale (GDS)
~Social Support: Medical Outcomes Study Social Support Survey (MOS-SSS)
~Comorbidity and Severity of Comorbidities: Charlson Comorbidity Index and Adult Comorbidity Evaluation (ACE-27)
~Age
~Haemoglobin
~CrCl
~Presence of geriatric syndromes"
15971406|NCT03101618|Other|Animal allergy|Allergic symptom occurs during exposure to laboratory or pet animal
15971407|NCT03101618|Other|Non-animal allergy|Allergic symptom does not occur during exposure to laboratory or pet animal
15971408|NCT03101605|Other|e-learning teaching module|As described
15971409|NCT03101605|Other|Standard teaching method|As described
15971410|NCT03101592|Other|Three-month ART dispensing|Patients enrolled in the three-month ART dispensing arm will receive a 90-day supply of ART from their provider for the duration of the study.
15971411|NCT03101592|Other|Six-month ART dispensing|Patients enrolled in the six-month ART dispensing arm will receive a 180-day supply of ART from their provider for the duration of the study.
15971412|NCT03101579|Drug|Pemetrexed|Pemetrexed,10-15 mg, intrathecal injection via lumbar puncture, twice per week for 2 weeks, followed by once per week for 2-4 weeks.
15971413|NCT03101579|Drug|Dexamethasone|Dexamethasone, 5 mg, intrathecal injection via lumbar puncture, simultaneously with pemetrexed, twice per week for 2 weeks, followed by once per week for 2-4 weeks.
15971414|NCT03101579|Drug|Folic Acid|Folic acid, 400 μg, oral, once per day, prior to the first intrathecal pemetrexed, until 21 days after the last intrathecal pemetrexed.
15971415|NCT03101579|Drug|Vitamin B12|A single dose of vitamin B12 1000 μg, intramuscular injection, before the first intrathecal pemetrexed.
15971416|NCT03101566|Drug|Gemcitabine|Gemcitabine 1000 mg/m2 IV
15971417|NCT03101566|Drug|Cisplatin|Cisplatin 25 mg/m2 IV
15971418|NCT03101566|Drug|Ipilimumab|Ipilimumab 1 mg/kg IV
15971419|NCT03101566|Drug|Nivolumab|Nivolumab 360 mg or 240 mg IV
15971420|NCT03101553|Behavioral|Interpretation Bias Modification|Eight 10-25 minute sessions of interpretation modification to reduce negative interpretation biases related to negative evaluation.
15971421|NCT03101553|Behavioral|Progressive Muscle Relaxation|Eight 15-minute sessions of progressive muscle relaxation (PMR).
15971422|NCT03101540|Drug|Omega-3 PUFA supplementation|Subjects received 2.2g of eicosapentaenoic acid (EPA) and 1.2g of docosahexaenoic acid (DHA) daily for the duration of the study.
15971423|NCT03101527|Drug|Omega-3 PUFA supplementation|Subjects received 2.2g of eicosapentaenoic acid (EPA) and 1.2g docosahexaenoic daily for the duration of the study
15971424|NCT03101514|Drug|Kanglaite|Kanglaite injection 200ml is injected intravenous from the first day to the last day of radiotherapy.
15971425|NCT03101514|Drug|chemotherapy|Cisplatin 80-100mg/m2 was used every 3 weeks during radiotherapy.
15971426|NCT03101501|Drug|Mitomycin c|Low dose mitomycin C at a concentration of 0.02% will be applied a duration of 10 to 30 seconds at the time of the surgical procedure.
15971427|NCT03101501|Device|Raindrop Near Vision Inlay|Implanted to improve near vision in Presbyopic or Pseudophakic subjects.
15971428|NCT03101488|Drug|KN035|KN035 is a monoclonal antibody drug which is formulated for subcutaneous injection in a single-use vial (brown neutral borosilicate) containing a total of 300 mg antibody in 1.5 ml of solution.
15971429|NCT03101475|Drug|Durvalumab (MEDI4736)|Durvalumab (MEDI4736) 1500mg Q4W in combination with tremelimumab for up to 4 doses/cycles, followed by durvalumab (MEDI4736) 1500mg Q4W for up to a maximum of 8 months with the last administration on week 48 unless there is unacceptable toxicity.
15971430|NCT03101475|Drug|Tremelimumab|Tremelimumab (75 mg IV Q4W) in combination with durvalumab (MEDI4736) (1500mg Q4W) for up to 4 doses/cycles
15971431|NCT03101475|Radiation|Sterotactic body radiation therapy (SBRT)|delivered in 3 fractions of 10 Gy over 1 week starting 8 to 14 days after first dose of immunotherapy
15971432|NCT03101475|Other|Radiofrequency ablation (RFA)|performed percutaneously under CT, MRI or sonographic guidance 8 to 14 days after start of immunotherapy
15971433|NCT03101462|Biological|Inactivated Influenza Vaccine|
15971434|NCT03101462|Biological|Live Attenuated Influenza Vaccine|
15971435|NCT03101449|Other|Finnish tube|Practice the exercise with Finnish tube before choir practice once a week for a period of 14 weeks.
15971436|NCT03101449|Other|Staw phonation|Practice the exercise straw phonation before choir practice once a week for a period of 14 weeks.
15971437|NCT03101436|Dietary Supplement|Extra Virgin Olive Oil and Red Wine|"Phase I: Extra VIrgin Olive Oil 80 grams per day (1 month)
~Washout Period: 15 days
~Phase II: Red Wine (270 ml per day) (1 month)"
15971438|NCT03101423|Drug|Interleukin-2|On +60 day after transplantation,check patients with STR more than or equal to 90%. transplantat interleukin-2 treatment per month
15971439|NCT03101423|Drug|Donor Regulatory T-Lymphocytes|On +60 day after transplantation,check patients with STR less than 90%. Donor Regulatory T-Lymphocytes infusion (DLI) treatment per month
15971440|NCT03101410|Behavioral|Gluten|Selected participants will be randomly allocated to treatment group (gluten or gluten free).
15971441|NCT03101410|Behavioral|Gluten free|Selected participants will be randomly allocated to treatment group (gluten or gluten free).
15971442|NCT03101384|Other|Diagnostic error|There is no intervention in our study. Patient will be managed with usual care. We will divide patients in the 2 groups according to the presence of diagnostic error.
15971443|NCT03101371|Drug|Catheter insertion with Povidone Iodine|The catheter will be treated with Povidone Iodine prior to insertion.
15971444|NCT03101371|Procedure|Standard of care catheter insertion|Catheter inserted right out of package.
15971445|NCT03101358|Drug|SOR007 (Uncoated Nanoparticle Paclitaxel) Ointment|One (1) Finger Tip Unit (FTU), or approximately 0.5 g, of SOR007 ointment will be applied topically to a 50 cm2 treatment area.
15971446|NCT03101345|Other|Peptamen® 1.5 vanilla|Administration orally
15971481|NCT03101085|Drug|S-equol|S-equol is an estrogen receptor β (ERβ) agonist. Provided in capsules
15971447|NCT03101332|Behavioral|Virtual Reality cognitive behavior therapy|"Cognitive interventions targeted to change catastrophic misinterpretations of the physiological symptoms that occur during a panic attack.
~Exposure via Virtual Reality to filmed sequences of environments typically feared by agoraphobic patients such as underground station/train, a tunnel, a lift and a public square, as well as exposure to the feared symptoms that occur in a typical panic attack.
~Interventions are delivered by a psychologist in face-to-face sessions."
15971448|NCT03101319|Drug|Vitamin D3 cholecalciferol|As mentioned in the description of the study arm
15971449|NCT03101319|Drug|B Complex Oral Tablet|As mentioned in the description of the study arm
15971450|NCT03101306|Other|MR scans|Additional imaging using MR scans.
15971451|NCT03101293|Drug|TAK-831|TAK-831 film-coated tablet.
15971452|NCT03101280|Drug|Atezolizumab|Atezolizumab 1200 mg (equivalent to an average body weight-based dose of 15 milligrams per kilogram [mg/kg]) will be administered by IV infusion once every 3 weeks, corresponding to a 21-day treatment cycle. Participants will receive atezolizumab starting on Cycle 1, Day 1. Participants deriving clinical benefit will be allowed to continue on study treatment until the absence of unacceptable toxicity or compelling evidence of disease progression.
15971453|NCT03101280|Drug|Rucaparib|The starting dosage level of rucaparib for Part 1 is 400 mg PO BID during a 21-day treatment cycle. During Part 1, the rucaparib doses were increased up to a maximum of 600 mg PO BID using a standard 3 + 3 dose escalation. RP2D was identified as 600 mg BID. During Part 2 of the study, rucaparib will be dosed at the RP2D determined in Part 1. Participants in Part 1 of the study will receive rucaparib starting on Cycle 1, Day 1. During Part 2, participants will receive rucaparib monotherapy during a 21-day run-in period. After completion of the rucaparib run-in period and the first on-treatment biopsy between Days 15 and 21 of the run-in period, participants will begin Cycle 1, Day 1 of the rucaparib. Participants deriving clinical benefit will be allowed to continue on study treatment until the absence of unacceptable toxicity or compelling evidence of disease progression.
15971454|NCT03101267|Drug|ASP4070|Intradermal vaccination at 2-week intervals
15971455|NCT03101267|Drug|Placebo|Intradermal vaccination at 2-week intervals
15971456|NCT03101254|Drug|LY3022855|LY3022855 is a colony-stimulating factor-1 receptor (CSF-1R) inhibitor
15971457|NCT03101254|Drug|Vemurafenib|Vemurafenib is a BRAF inhibitor that works by blocking altered BRAF proteins from stimulating the growth of melanoma cancer cells
15971458|NCT03101254|Drug|Cobimetinib|Cobimetinib works by blocking a protein called MEK that has been known to promote melanoma growth
15971461|NCT03101228|Behavioral|Reduced sitting|Subjects are guided to limit their sitting time during the day for 1 hour/day, by adding light activity with the help of an activity monitor. Subjects are not encouraged to increase their moderate to vigorous physical activity levels.
15971462|NCT03101215|Dietary Supplement|phosphorus|adding of phosphorus to high carbohydrate meal
15971463|NCT03101202|Device|SSD tube|The SSD tube allows the suction of subglottic secretions that collect above the cuff of the endotracheal tube
15971464|NCT03101189|Drug|ACT-541468|Capsule
15971465|NCT03101189|Drug|placebo|Matching placebo capsule
15971466|NCT03101176|Drug|SonoVue|The ultrasound contrast agent used for the CEUS specific ultrasound mode
15971467|NCT03101163|Biological|Autologous peripheral blood stem cells and hyaluronic acid|Regimen of intra-articular PBSC and HA injections and postoperative physiotherapy
15971468|NCT03101163|Other|Hyaluronic acid|Regimen of intra-articular HA injections and postoperative physiotherapy
15971469|NCT03101150|Drug|400 IU Vitamin D3|Antenatal multivitamin
15971470|NCT03101150|Drug|4000 IU Vitamin D3|4000 IU Vitamin D3 (cholecalciferol) daily = 40 drops daily
15971471|NCT03101137|Drug|Caudal block with dexmedetomedine|After induction, the electrical cardiometry is applied in supine position and a measurement for the baseline cardiac output, systemic vascular resistance and stroke volume is taken. In left lateral position, the back is sterilized. The block is done by introducing a 23-gauge needle perpendicular to the sacrococcygeal membrane. The needle is inserted until there is release of resistance as it pierces the sacro-coccygeal membrane. Then, it is directed upwards to make an angle of 20-30° with the skin about 2 mm. 1 ml/kg bupivacaine 0.25% along with dexmedetomidine 1 μg/kg (diluted with normal saline to 1ml) is injected over about 60s. Then, another measurement for the hemodynamics is taken at 5, 10, 20 and 30 minutes after caudal block.
15971472|NCT03101137|Drug|Caudal dexamethasone|After induction, the electrical cardiometry is applied in supine position and a measurement for the baseline cardiac output, systemic vascular resistance and stroke volume is taken. In left lateral position, the back is sterilized. The block is done by introducing a 23-gauge needle perpendicular to the sacrococcygeal membrane. The needle is inserted until there is release of resistance as it pierces the sacro-coccygeal membrane. Then, it is directed upwards to make an angle of 20-30° with the skin about 2 mm. 1 ml/kg bupivacaine 0.25% along with dexamethasone 0.1mg/kg (diluted with normal saline to 1ml) is injected over about 60s. Then, another measurement for the hemodynamics is taken at 5, 10, 20 and 30 minutes after caudal block.
15971473|NCT03101137|Drug|Control (bupivacaine)|After induction, the electrical cardiometry is applied in supine position and a measurement for the baseline cardiac output, systemic vascular resistance and stroke volume is taken. In left lateral position, the back is sterilized. The block is done by introducing a 23-gauge hypodermic needle perpendicular to the sacrococcygeal membrane. The needle is inserted until there is release of resistance as it pierces the sacro-coccygeal membrane. Then, it is directed upwards to make an angle of 20-30° with the skin about 2 mm. 1 ml/kg the control (bupivacaine) 0.25% is injected over about 60s. Then, another measurement for the hemodynamics is taken at 5, 10, 20 and 30 minutes after caudal block.
15971474|NCT03101124|Drug|Tranexamic Acid 25 mg/ml for wound surface moistening|Wound surface moistened with 20 ml of tranexamic acid 25 mg/ml (total dose 500 mg) prior to wound closure
15971475|NCT03101124|Drug|Tranexamic Acid 5 mg/ml as bolus in wound cavity|200 ml of tranexamic acid 5 mg/ml (total dose 1 g) as a bolus instilled into the wound cavity after wound closure, which will remain in the cavity until the activation of drains one hour later
15971476|NCT03101124|Drug|Tranexamic Acid Injectable Solution|1 g of tranexamic acid administered intravenously in accordance with prevailing routines directly prior to planned surgical procedure.
15971482|NCT03101085|Other|Placebo|Placebo capsules matched in size and color to S-equol capsules
15971483|NCT03101072|Other|"Fixed long antibiotic course of 14 days"|Only the duration of antibiotic therapy will be investigated in this study. (In all arms, the choice and mode of administration (IV vs. PO) of antibiotic(s) will be left to the patient's attending physician and consulting infectious disease specialist and thus will follow usual standards of care.)
15971484|NCT03101072|Other|"Fixed short antibiotic course of 7 days"|Only the duration of antibiotic therapy will be investigated in this study. (In all arms, the choice and mode of administration (IV vs. PO) of antibiotic(s) will be left to the patient's attending physician and consulting infectious disease specialist and thus will follow usual standards of care.)
15971485|NCT03101072|Other|"Individualized duration of antibiotic therapy"|Only the duration of antibiotic therapy will be investigated in this study. (In all arms, the choice and mode of administration (IV vs. PO) of antibiotic(s) will be left to the patient's attending physician and consulting infectious disease specialist and thus will follow usual standards of care.)
15971486|NCT03101059|Procedure|Non invasive ventilation - Continuous Positive Airway Pressure|To identify, through bronchoscopy, the prevalence of collapse and whether it is possible to counteract an optimum pressure generated by NIV with CPAP that reduces tracheal and bronchial collapse in patients with SMK; To study the frequency of OSAS in patients with MKS ; Record reversal of collapse with CPAP using chest tomography; To identify the impact of CPAP on the distribution of pulmonary ventilation through the analysis of electrical impedance tomography.
15971487|NCT03101046|Drug|Cabazitaxel|Experimental treatment arm: patients will be treated with intravenous cabazitaxel 20 mg/m² every 3 weeks up to 10 cycles.
15971488|NCT03101046|Drug|Docetaxel|standard treatment arm and cohort: Docetaxel is administered at the dose of 75 mg/m² over 1 hour every 3 weeks for 6 cycles (D1=D22).
15971489|NCT03101033|Device|Mechanical epidural neuroplasty|Guided by X-ray transillumination,an epidural needle will be inserted through sacral hiatus. A catheter （BS epidural catheter, BioSpine Co., Ltd, Korea） will be inserted through the epidural needle to the epidural space where disc herniation locates, mechanical adhesiolysis will be implemented.
15971490|NCT03101033|Drug|Transforaminal epidural compound betamethasone injection|Guided by X-ray transillumination, A puncture needle will be inserted to the intervertebral foramen in the vicinity of affected nerve root, and steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan®, Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected.
15971491|NCT03101033|Drug|Caudal epidural compound betamethasone injection|steroid injectant consists of 1 ml of Compound Betamethasone Injection (Diprospan® Schering-Plough Labo N.V., Belgium) and 4ml of 0.2% lidocaine will be injected through the epidural catheter after mechanical epidural neuroplasty.
15971492|NCT03101033|Drug|Epidural hyaluronidase injection|Hyaluronidase of 1500 IU （Sine®, SPH NO.1 Biochemical and Pharmaceutical Co., LTD）will be injected through the epidural catheter after mechanical epidural neuroplasty and caudal epidural compound betamethasone injection.
15971493|NCT03101020|Other|Active Visceral Manipulation|Visceral manipulation techniques consists of deep manual pressure in certain points of the abdomen and the amount of pressure will be respected according to the participant discomfort or pain. It will be performed cardia mobilization, pylori mobilization, Oddi's sphincter mobilization, duodenum-jejunum valve mobilization, ileocecal valve mobilization, global technique for the liver, global hemodynamic technique. Each technique will last 1 minutes, with the two last ones repeated 10 times.
15971494|NCT03101020|Other|Standard care physiotherapy|The care includes advice for correct postures to perform daily activities; abdominal, pelvic and lumbar muscles re-training and strengthening; and advice to perform at least 20 minutes' walk three times a week. The therapist will treat the participants once a week for a 5-week period. All treatment session will last 40 minutes.
15971495|NCT03101020|Other|Placebo Visceral Manipulation|The placebo intervention involves light touch at the same regions of the techniques the active visceral manipulation, and no intention on the part of the therapist to impart any therapeutic technique
15971496|NCT03101007|Device|ATTUNE Knee Prosthesis by DePuy|Total Knee Replacement (TKR) Surgery with cementless ATTUNE rotating platform Knee Prosthesis by DePuy
15971497|NCT03101007|Device|LCS Knee Prosthesis by DePuy|Total Knee Replacement Surgery with cementless LCS rotating platform Knee Prosthesis by DePuy
15971498|NCT03100994|Drug|Bupivacaine|injecting anesthetics to different local
15971499|NCT03100994|Device|Ultrasound|Ultrasound guided nerve block
15971500|NCT03100981|Behavioral|Internet-delivered Mindfulness-Based Cognitive Therapy|"Internet-delivered Mindfulness-Based Cognitive Therapy is a trainer-assisted course based on the manual for Mindfulness-Based Cognitive Therapy for depression. The course consists of 8 modules, one per week, for 8 weeks and one additional week for flexibility for the participants. In total 9 weeks with weekly written contact to the personal instructor.
~Each module has an overall theme with written theory, approximately 45 minutes of daily mindfulness practice and other daily assignments with the purpose of strengthening awareness in the everyday life."
15971501|NCT03100981|Behavioral|Waitlist control|"Participants in the control arm of the study will receive treatment as usual, which means that they are not offered interventions targeting psycho-social distress but also not prevented from participating in or seeking other psycho-social treatment during the course of the study.
~After the 6-months follow-up time has passed participants will get the opportunity to participate in 8 weeks of therapist-assisted internet-delivered Mindfulness-Based Cognitive Therapy, if the intervention is found efficient."
15971502|NCT03100968|Procedure|Palpation|Traditional epidural methods used for the identification of the midline using palpation prior to procedure
15971503|NCT03100968|Device|Ultrasound|Lumbar spinal ultrasound performed for identification of the midline prior to procedure.
15971504|NCT03100955|Drug|cisplatin, etoposide|The recommended regimen is cisplatin plus etoposide. cisplatin 75 mg/m2 iv on day 1, etoposide 120 mg/m2 iv on day 1-3, 3 weeks a cycle, total for 6 cycles is allowed.
15971505|NCT03100955|Drug|cisplatin, etoposide, apatinib|Standard chemotherapy treatment for patients with small cell lung cancer. Chemotherapy regimen contains a platinum drug and a topoisomerase inhibitor. Platinum drug=cisplatin 75 mg/m2 iv on day 1; topoisomerase inhibitor=etoposide 120 mg/m2 iv day 1-3, 3 weeks a cycle, total numbers of cycles 6.Used drugs=cisplatin and etoposide. Numbers of cycles 6. In addition to this, subjects will receive VEGF-TKI apatinib oral daily after chemotherapy treatment. Apatinib 500mg oral, once a day, until disease progression or death or un-tolerated toxicites.
15971506|NCT03100942|Drug|Lanraplenib|1 x 30 mg tablet administered orally once daily
15971510|NCT03100942|Drug|Filgotinib placebo|1 x tablet administered orally once daily
15971511|NCT03100942|Drug|Tirabrutinib placebo|1 x tablet administered orally once daily
15971512|NCT03100929|Diagnostic Test|Ultrasound|Pre-operational ultrasound for the detection of fetal heart rate, fetal presentation and presence of nuchal cord.
15971513|NCT03100916|Drug|BI 690517|once daily
15971514|NCT03100916|Drug|Placebo|once daily
15971515|NCT03100916|Drug|BI 690517 (Reference)|Fasting
15971516|NCT03100916|Drug|BI 690517|Non- fasting
15971517|NCT03100903|Drug|BI 655130|single dose
15971518|NCT03100890|Other|Preoperative training (hospital)|Preoperative hospital training
15971519|NCT03100890|Other|Preoperative training (home)|Preoperative in-home training
15971520|NCT03100877|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo ASCT
15971521|NCT03100877|Drug|Cyclophosphamide|Given IV
15971522|NCT03100877|Biological|Filgrastim|Given SC or IV
15971523|NCT03100877|Other|Laboratory Biomarker Analysis|Correlative studies
15971524|NCT03100877|Drug|Lenalidomide|Given PO
15971525|NCT03100877|Procedure|pheresis|Undergo apheresis
15971526|NCT03100877|Drug|Melphalan|Given IV
15971527|NCT03100877|Biological|Palifermin|Given IV
15971528|NCT03100877|Radiation|Total Marrow Irradiation|Undergo TMI
15971529|NCT03100864|Drug|Spesolimab|12 weeks treatment
15971530|NCT03100851|Dietary Supplement|Lactobacillus casei strain Shirota|a bottle of 100 mililiter probiotic dairy beverage containing 10^8 CFU Lactobacillus casei strain Shirota every day after lunch.
15971531|NCT03100838|Drug|Nifedipine 60 MG Extended Release Oral Tablet|Reference Drug (Brand)
15971532|NCT03100838|Drug|Nifedipine 60 MG Extended Release Oral Tablet|Test Drug (Generic)
15971533|NCT03100838|Drug|omeprazole/sodium bicarbonate|Proton Pump Inhibitor/Antacid for drug-drug interaction
15971534|NCT03100838|Device|SmartPill (TM)|Gastric pH measurement using SmartPill (TM) Technology
15971535|NCT03100825|Drug|QVM149|QVM149 (indacaterol acetate/glycopyrronium bromide/mometasone furoate)
15971536|NCT03100812|Behavioral|More intensive CHW Intervention|Group A participants will attend 4 monthly 90 minute group health education sessions that provide the tools and strategies to promote heart health to Filipino American individuals, families, and communities on high blood pressure and CVD. The CHWs will lead these sessions utilizing NHLBI's Healthy Heart Healthy Family, A CHW's Manual for the Filipino Community. Each of the group health education sessions will discuss different content related to CVD, hypertension, and other CVD risk factors. The first session focuses on assessing heart disease risk and recognition of heart attack signs. The second session focuses on physical activity and weight management and blood pressure control. The third session addresses control of cholesterol, and diabetes. The final 4th session teaches participants about nutrition and living smoke free.
15971537|NCT03100812|Behavioral|Less Intensive CHW Intervention|Individuals randomized to the less intensive CHW intervention will have the baseline, 4 month, and 8 month interviews and blood pressure measurements will be collected in those succeeding time points. Participants will also receive a 30 minute one on one session from the CHW and a referral to a physician if needed.
15971538|NCT03100799|Procedure|Arthroscopy|Arthroscopy of the target knee
15971539|NCT03100799|Procedure|Arthrocentesis|Arthrocentesis of the target knee and contralateral knee (if patient consents)
15971540|NCT03100799|Diagnostic Test|MRI|MRI with and without a gadolinium-based contrast agent
15971541|NCT03100786|Drug|Dexamethasone|Active treatment with dexamethasone from randomisation (IV followed by oral according to disease severity at the start of treatment): Dexamethasone for intravenous injection and dexamethasone for oral ingestion
15971542|NCT03100786|Other|Placebo|Treatment with matched placebo: Standard saline for intravenous injection and placebo oral tablets containing cellulose
15971543|NCT03100773|Other|Oral health educational strategy|Oral health educational strategy consisted of four consecutive sessions (once a week) about etiological factors of caries (using visual aids), oral hygiene instructions (using models), supervised toothbrushing and explanation of atraumatic restorative treatment (indications and stages).
15971544|NCT03100773|Procedure|Atraumatic Restorative Treatment|Atraumatic Restorative Treatment was performed using hand instruments for opening and cleaning the cavities and a high-viscosity glass-ionomer for restoration.
15971545|NCT03100747|Procedure|Bilamellar 3 mm|Trichiasis surgery using the bilamellar tarsal rotation procedure with incision 3 mm from the eyelid margin
15971546|NCT03100747|Procedure|Bilamellar 5 mm|Trichiasis surgery using the bilamellar tarsal rotation procedure with incision 5 mm from the eyelid margin
15971547|NCT03100747|Procedure|Trabut 3 mm|Trichiasis surgery using Trabut procedure with incision 3 mm from the eyelid margin
15971548|NCT03100734|Biological|Benepali|As specified in the treatment arm
15971549|NCT03100734|Biological|Enbrel|As specified in the treatment arm
15971550|NCT03100721|Behavioral|PNE+Physiotherapy|Physiotherapy cover kinesitherapy and exercises techniques. Besides that it will be covered the understanding and acknowledgement about how pain is processed.
15971551|NCT03100721|Procedure|Physiotherapy|Physiotherapy cover kinesitherapy and exercises techniques.
15971552|NCT03100708|Procedure|PIPAC|"Cisplatin 7.5 mg/m2 body surface in 150 ml NaCl 0,9% + Doxorubicin 1.5 mg/m2 body surface in 50 ml NaCl 0,9% in patients with ovarian, gastric, pancreatic cancer and in primary peritoneal tumors.
~Oxaliplatin 92 mg/m2 body surface in 150 ml dextrose solution in patients with colorectal cancer.
~The chemotherapeutics will be admitted to the abdomen by a nebulizer at a pressure of 200 psi and 12 mmHG with 0.5 mL/sec. Afterwards the chemotherapeutics can react for 30min before the abdominal gas will be drained to the clinics filtering system."
15971553|NCT03100695|Other|Concentrated autologous PRP-BMA|Injection of autologous, concentrated platelet-rich plasma and bone marrow aspirate at the site of fixation.
15971554|NCT03100669|Procedure|Pectus surgery|Patients undergoing surgical repair of pectus excavatum or carinatum
15971555|NCT03100656|Other|A breakfast sandwich|A meat-based breakfast sandwich
15971556|NCT03100643|Other|mHealth N'Gage mobile application|To enhance HIV care engagement among couples using mobile technology.
15971557|NCT03100630|Drug|RO7239361|Specified dose on specified days
15971584|NCT03100357|Other|Thyroidectomy|Thyroid surgery for benign nodular goiter
15971558|NCT03100617|Behavioral|Psychosocial caregiver intervention|Modified version of the REACH-VA intervention for family caregivers of persons with dementia. The intervention has several components including 1) caregiver education, 2) risk assessment, 3) caregiver needs assessment, 4) caregiver skill building and problem solving, and 4) caregiver stress reduction.
15971559|NCT03100604|Drug|desflurane,|Patients were divided into two groups according to inhalation agent administered for the surgery; Sevofluran, Group S (n=25) and Desfluran, Group D (N=25).
15971560|NCT03100604|Drug|Sevoflurane|For a drug, use generic name if established. Use the same name as in the associated Arm/Group Description(s).
15971561|NCT03100591|Drug|14C-radiolabeled ACT-132577|Single oral dose of 3.7 megabecquerel (MBq) (100 microcurie [μCi]) 14C-radiolabeled ACT-132577 administered as 1 capsule of 25 mg
15971562|NCT03100578|Device|WOPN TRANSMURAL DRAINAGE: PLASTIC STENT|"Endoscopic ultrasound-guided transmural drainage of walled-off pancreatic necrosis:
~The pancreatic collection will be located with the linear echoendoscope, and we will proceed to choose an optimal area to perform the puncture guided by EUS; with the absence of intervening vessels.
~This collection will be punctured with a 19 G needle or with an electrocautery device directly. Guidance will be advanced through the needle and the ostomy will proceed according to the routine of the experienced endoscopist.
~Placement of a plastic double pigtail, 5-10 cm in length, diameters 7-8,5-10 Fr. Minimum one 10 Fr prosthesis.
~Arm associated: PLASTIC STENT"
15971563|NCT03100578|Device|WOPN TRANSMURAL DRAINAGE: METALLIC STENT|"Endoscopic ultrasound-guided transmural drainage of walled-off pancreatic necrosis:
~The pancreatic collection will be located with the linear echoendoscope, and we will proceed to choose an optimal area to perform the puncture guided by EUS; with the absence of intervening vessels.
~This collection will be punctured with a 19 G needle or with an electrocautery device directly. Guidance will be advanced through the needle and the ostomy will proceed according to the routine of the experienced endoscopist.
~Placement of a metal self-expanding fully covered luminal apposition stent: 10, 15 or 20 mm diameter.
~Arm associated: SELF EXPANDABLE METALLIC STENT"
15971564|NCT03100565|Drug|local lidocaine spray|The lidocaine spray will be introduced to the cervix just before the biopsy procedure
15971565|NCT03100565|Other|forced coughing|The patients will be asked to forced coughing during the biopsy procedure
15971566|NCT03100552|Diagnostic Test|Endoscopic imaging|Analysis of the presence of dysplasia within sessile serrated polyps (SSP) using endoscopic imaging (high definition white light +- narrow band imaging)
15971567|NCT03100539|Other|Therapist treated massage|Participants randomized to the therapist-treated massage (TT-M) arm will receive a standardized Swedish massage protocol tailored to chronic neck pain. Massage sessions will involve a maximum of 60 minutes of hands-on, table time and occur twice a week (a frequency which balances practicality and efficacy) for 3 months.
15971568|NCT03100526|Behavioral|PACT Intensive Management|"Purpose: Implement a Patient Aligned Care Team (PACT) model that identifies and proactively manages Veterans at the highest risk for hospital admission and death while they are still in the ambulatory care setting.
~Goal:
~Reduce emergency department and urgent care utilization, hospitalization, and mortality in complex, high risk patients
~Improve Veteran and staff satisfaction
~Objectives:
~Maintain the patient in the home setting as much as possible
~Secure appropriate home environment to facilitate health and well-being
~Utilize comprehensive team-based care
~Engage appropriate VHA programs to provide interdisciplinary, coordinated, and timely management of complex medical issues"
15971569|NCT03100513|Drug|Lactulose|(lactulose) (20 to 30 g administered orally or by nasogastric tube (3 or more doses within 24 hours) or 200 g by rectal tube if oral intake was not possible or inadequate
15971570|NCT03100513|Drug|Polyethylene Glycol|PEG as single dose of (3sachets if patient <75Kg over 3 hours or 4 sachets if patient >75Kg over 4 hours) dministered orally or via a nasogastric tube (each sachet 64g/25Kg must be dissolved in one liter of water).
15971571|NCT03100500|Drug|QMF149|QMF149 150/320 μg once daily, delivered as powder in hard capsules via Concept1 inhaler
15971572|NCT03100487|Device|Apple iPod Shuffle|One session at least 5 days a week for a total of 8 weeks
15971573|NCT03100461|Other|I2|"A touch screen computer delivered implementation intentions (I2) intervention on CRC screening. Implementation intentions are the exact steps (the when, what, where, how) one will take to complete a test (the date and time, at home or at the doctor's office, with what supplies, etc.)."
15971574|NCT03100461|Other|Health Education|Standard of care approach that will provide basic information on CRC screening.
15971575|NCT03100448|Device|On1 Concept|NobelActive implant placement with simultaneous On1 Base placement
15971576|NCT03100435|Device|Er:YAG Laser|Titanium disks will be decontaminated ex-vivo with the Er:YAG laser.
15971577|NCT03100435|Other|Carbon Fiber Curette|Titanium disks will be decontaminated ex-vivo with carbon fiber curettes
15971578|NCT03100422|Device|ARMin|arm therapy robot
15971579|NCT03100422|Other|Occupational Therapy|bilateral arm training
15971580|NCT03100409|Other|Dietary modification|"Dietary intervention will consist on a low residue diet: 20% kcal from fat, 5g lactose/day, 20g fiber/day (5g from insoluble fiber).
~Dietary intervention will be adapted to the patient's individual requirements, according to the presence of comorbidities or renal deterioration.
~No comorbidities. Energy: 20-30 kcal/kg of body weight/day. Protein: 1.3 g/kg of body weight/day.
~Comorbidities (diabetes, hypertension), or geriatric patient. Energy: 25-30 kcal/kg of body weight/day. Protein: 1.5 g/kg of body weight/day.
~Renal deterioration. Energy: 30-35 kcal/kg of body weight/day. Protein: 1 g/kg of body weight/day. Sodium: 2000-2300 mg/day. Potassium: 1900-2730 mg/day. Phosphorus: 800-1000 mg/day."
15971585|NCT03100344|Drug|Nemolizumab|Injection every 4 weeks during 24 weeks (last injection at week 20)
15971586|NCT03100344|Drug|Placebo|Injection every 4 weeks during 24 weeks (last injection at week 20)
15971587|NCT03100331|Other|Neuropsychological testing|Comprehensive neuropsychological assessment and implementation of appropriate support and resources.
15971588|NCT03100318|Drug|FYU-981|Oral daily dosing for 14 weeks
15971589|NCT03100318|Drug|Benzbromarone|Oral daily dosing for 14 weeks
15971590|NCT03100305|Other|Collection of blood and urine|Collection of blood and urine before nutritional support, during total parenteral nutrition, during partial parenteral nutrition and during enteral nutrition
15971591|NCT03100292|Other|Sleeve gastrectomy or Roux-en-Y gastric bypass|
15971592|NCT03100279|Behavioral|Coping Cat/CAT Project|"The Coping Cat program, developed by Kendall and colleagues (Kendall, 1994; Kendall, 2000; Kendall, Kane, Howard, & Siqueland, 1989; Kendall, Flannery-Schroeder et al., 1997), involves (1) teaching children to identify their own anxious feelings and physiological signs of anxiety, (2) teaching children to identify their own anxiety-provoking cognitions, (3) developing a plan to guide coping - a plan that involves changing the child's thoughts (into positive self-talk) and actions (into self-initiated exposures), and (4) self-evaluation and self-reward. The therapist uses modeling (e.g., revealing therapist's own anxiety and sharing successful coping experiences), in vivo exposure tasks, role-playing (e.g., to prepare for exposure tasks), relaxation training, and contingent reinforcement (e.g., for trying and for succeeding at exposure tasks), in developing these four themes."
15971593|NCT03100279|Behavioral|Primary and Secondary Coping Enhancement Therapy|PASCET is a brief (11-15 sessions) CBT program for depressed youths typically aged 8-15. Sessions and practice assignments are built on findings concerning cognitive and behavioral features of youth depression (e.g., Lewinsohn et al., 1990; Stark et al., 1987), and on the two-process model of perceived control and coping (Rothbaum, Weisz, & Snyder, 1982; Weisz et al., 1984a,b). In this model, primary control involves efforts to cope by making objective conditions (e.g., one's activities, one's peer status) conform to one's wishes. In contrast, secondary control involves coping by adjusting oneself (e.g., one's expectations, interpretations) to fit objective conditions, so as to influence their subjective impact without altering the actual conditions. The goal is for youngsters to build their skills in primary and secondary control coping, and apply those skills to events and conditions that can trigger depression. Therapists are guided by a Therapist's Manual and use a youth workbook.
15971594|NCT03100266|Dietary Supplement|Probiotic|Lactobacillus rhamonosus GG
15971595|NCT03100266|Other|Inactive capsules|Placebo
15971596|NCT03100253|Drug|Tocilizumab|8 mg/kg i.v. every 4 weeks OR 162 mg s.c every seven days
15971597|NCT03100253|Drug|Etanercept|a. Etanercept if initial failure to monoclonal antibodies: infliximab, adalimumab, golimumab or certolizumab
15971598|NCT03100253|Drug|Infliximab|infliximab if initial failure to the receptor fusion protein, etanercept.
15971599|NCT03100253|Drug|Adalimumab|adalimumab if initial failure to the receptor fusion protein, etanercept.
15971600|NCT03100253|Drug|Golimumab|golimumab if initial failure to the receptor fusion protein, etanercept.
15971601|NCT03100253|Drug|Certolizumab Pegol|Certolizumab Pegol if initial failure to the receptor fusion protein, etanercept.
15971602|NCT03100240|Procedure|Modified Supper Long Protocol|In Modified Supper Long Protocol, GnRH-a was used twice in mid-luteal phaes
15971603|NCT03100227|Other|PET [18F] FDG|Measurement of carbohydrate metabolism at the individual level. Standardization of the individual imaging data in a standard anatomical space and then calculation of an average image through the group-level controls.
15971604|NCT03100227|Other|Anatomical MRI|All subjects will benefit from a 3D anatomical MRI to control the normality of their MRI and an automatic segmentation of 73 brain regions by multi-atlas segmentation.
15971605|NCT03100214|Other|Exercise|Patients randomized to the intervention group, in addition to routine physical therapy follow-up, will receive an early rehabilitation program, which will begin within the first 48 hours after admission. The patient will perform physical training (aerobic and anaerobic) 5 times a week during the hospitalization period, with sessions about an hour. The professional who supervises the training will be blinded to the results of the measurements.
15971606|NCT03100214|Other|Control|Patients randomized to the control group will continue to receive the physiotherapeutic follow-up performed by the physiotherapist of the Program for Adults with CF during the hospitalization period. Supervision includes respiratory physiotherapy involving inhalation therapy and techniques for removal of secretions
15971607|NCT03100201|Other|Intervention Armeo®Spring|The robotic-assisted training will be performed using the clinically evaluated Armeo®Spring medical device (Hocoma AG, Zurich, Switzerland). By means of a sensory orthosis, arm movements will be supported and transmitted to a computer system and visually shown on a screen.
15971608|NCT03100201|Other|Control Group|The control group will receive conventional occupational- and physiotherapy over 3 weeks
15971609|NCT03100188|Other|modified PD prescription|For patients on CAPD, fewer daily exchanges or fewer total weekly exchanges are prescribed. Patients on CCPD are prescribed shorter cycler time or fewer total cycles during the week.
15971610|NCT03100175|Behavioral|physiotherapy|strength training for upper and lower limbs fitness and balance work out
15971611|NCT03100162|Dietary Supplement|Probiotic|
15971612|NCT03100162|Dietary Supplement|Placebo|
15971616|NCT03100136|Drug|[11C]PF-06809247|PET Tracer
15971617|NCT03100123|Drug|Aspirin 81 mg|Aspirin 81 mg po daily in tablet form.
15971618|NCT03100123|Drug|Low-molecular-weight heparin|The LMWH regime will be at the discretion of the treating physician, with a suggested regime as follows: tinzaparin 4,500 IU sc daily until 20 weeks gestation, and then 4,500 IU sc twice daily until 37 weeks gestation.
15971619|NCT03100110|Device|NeuroCognitive Communicator|Comprises an electrode array in prefrontal cortex, another in motor cortex, Blackrock NeuroPort system and connectors, augmentative assistive communication application, robotic arm, and virtual reality environment.
15971622|NCT03100071|Drug|Apixaban|Patients will be treated with Low Molecular Weight Heparin (LMWH) for 1 week and then with apixaban 5 milligram (mg) twice daily for 11 weeks.
15971623|NCT03100058|Drug|LIK066|LIK066 will be supplied in different doses as tablets to be taken orally.
15971624|NCT03100058|Drug|Placebo|Placebo
15971625|NCT03100045|Drug|Artesunate Suppositories|Artesunate suppositories for the treatment of (AIN2/3) Anal Intraepithelial Neoplasia
15971626|NCT03100032|Biological|NVD-001|At the Investigator's discretion, one or two interbody polyetheretherketone (PEEK) cage(s) filled and surrounded with NVD-001.
15971627|NCT03100032|Procedure|Standard of Care|At the Investigator's discretion, one or two interbody polyetheretherketone (PEEK) cage(s) filled and surrounded with autologous locally cancellous bone (laminectomy)
15971628|NCT03100019|Dietary Supplement|Resveratrol|
15971629|NCT03100019|Drug|Placebo|
15971630|NCT03100006|Drug|Nivolumab|240mg of IV Nivolumab is administered over 30 mins every 2 weeks
15971631|NCT03100006|Drug|Oregovomab|IV Oregovomab is administered over 20 mins every 4 weeks at dose levels: 2mg, 1mg, or 0.5mg
15971632|NCT03099993|Other|Measurement of maximal forces of elbow pronosupination and flexion-extension|Maximal forces of elbow pronosupination and flexion-extension will be measured with a portable dynamometer.
15971633|NCT03099980|Biological|secukinumab|secukinumab 300 mg (2 x 150 mg pre-filled syringe) administered at Baseline, Weeks 1, 2, 3, 4, and then Q4W for 24 weeks via subcutaneous injections
15971634|NCT03099967|Device|Transcatheter closure of an atrial septal defect or patent foramen ovale.|In a prospective study in adults troponin T (TnT) serum concentrations were determined before and the day after transcatheter closure of an atrial septal defect (ASD) or patent foramen ovale (PFO).
15971635|NCT03099941|Other|Biofeedback|The aim of this study is to investigate effects of a biofeedback application that is alternative to physical therapist feedback in core stabilization training of patients with CNLBP.
15971636|NCT03099915|Other|completion of self-reported questionnaires|Single completion: Participants will have to complete self-reported questionnaires based on gina criteria and 12-item general health questionnaire
15971637|NCT03099902|Diagnostic Test|Lung function|Spirometry test
15971638|NCT03099902|Diagnostic Test|White blood cell DNA extraction|GSTP1 and TNFa polymorphisms with PCR
15971639|NCT03099902|Diagnostic Test|Urinary testing|Urinary nicotine and cotinine detection
15971640|NCT03099889|Behavioral|Physical Activity|Physical activity intervention based upon stage of change and social cognitive theory based interventions
15971641|NCT03099876|Procedure|treatment period|7 days treatment or 10 days treatment
15971642|NCT03099863|Drug|Cystoscopic Fluid containing Neosporin G. U. Irrigant|Normal saline cystoscopic fluid containing Neosporin G. U. Irrigant 1mL/1000mL
15971643|NCT03099863|Procedure|Cystoscopy|Diagnostic cystoscopy performed during pelvic floor surgery
15971644|NCT03099863|Drug|Cystoscopic Fluid/Placebo|Normal saline cystoscopic fluid
15971645|NCT03099850|Other|Data Management and Monitoring|The Coordinating and Data Management Center (CDMC) at MD Anderson Cancer Center responsible for monitoring protocol and regulatory compliance for consortium. CDMC responsible for maintaining and tracking IRB approval and regulatory documents from each site throughout the life of the study.
15971646|NCT03099824|Drug|GC4711 Oral Capsule G-101|82 mg (1 capsule)
15971647|NCT03099824|Drug|IV GC4419|GC4419 will be infused IV as a single dose of 27 mg in 247 mL normal saline, totaling 250 mL, over a 60-minute period using a programmable pump.
15971648|NCT03099824|Drug|GC4711 Oral Capsule G-101|164 mg (2 capsules)
15971649|NCT03099824|Drug|GC4711 Oral Capsule G-101|246 mg (3 capsules)
15971650|NCT03099824|Drug|GC4711 Oral Capsule G-111|175 mg (1 capsule)
15971651|NCT03099824|Drug|GC4711 Oral Capsule G-112|145 mg (1 capsule)
15971652|NCT03099824|Drug|GC4711 Oral Capsule G-119|233 mg (1 capsule)
15971653|NCT03099824|Drug|GC4711 Oral Capsule G-125|233 mg (1 capsule)
15971654|NCT03099824|Drug|IV GC4711|GC4711 will be infused IV as a single dose of 30 mg in 250 mL normal saline, totaling 251 mL, over a 60-minute period using a programmable pump.
15971655|NCT03099811|Behavioral|Incentive plan|The caregiver and designated social network member can each receive monthly financial incentives over the 6 month time interval. Additional monthly incentives will be received at 3- and 6-months if the participant's previous two monthly biomarker levels were below the lower-limit cutoff.
15971656|NCT03099811|Behavioral|Smoking cessation|Participants who wish to quit smoking will be referred upon study recruitment to the smoking cessation program that is provided at no-cost by the Maryland Department of Health and Mental Hygiene (DMMH). The DMMH provides standard counseling and nicotine replacement pharmacotherapies for clients and is offered online or at six health centers throughout Baltimore City.
15971657|NCT03099798|Other|Questionnaires|"All patients will complete a number of questionnaires at different time points.
~SF-12, WHOQoL-Bref, EQ-5D-5L, iPCQ, iMCQ
~1 week, 1 month, 3, 6 and 12 months after treatment"
15971658|NCT03099798|Diagnostic Test|MRI abdomen|Patients who were treated with splenic artery embolization will also undergo an MRI one month and one year after treatment.
15971659|NCT03099785|Drug|Rifamycin SV 600mg t.i.d.|Morning: one 600 mg tablet Afternoon: one 600 mg tablet Evening: one 600 mg tablet
15971660|NCT03099785|Drug|Rifamycin SV b.i.d. + Placebo|Morning. one 600 mg tablet Afternoon: one matching placebo tablet Evening: one 600 mg tablet
15971661|NCT03099785|Drug|Placebo t.i.d.|Morning. one matching placebo tablet Afternoon: one matching placebo tablet Evening: one matching placebo tablet
15971662|NCT03099772|Behavioral|CBT-IU|Cognitive-behavioral therapy for intolerance of uncertainty
15971663|NCT03099759|Dietary Supplement|Vitamin D|Vitamin D2/D3
15971664|NCT03099746|Behavioral|INVOLVE|Interactive content and decision coaching with tailored framing of messages to subject's informational processing style and stage of change to promote participatory decision making behavior. Consideration of options, consequences, values, and preferences to formulate an informed decision.
15971665|NCT03099746|Behavioral|Informational Support|Passive, non-tailored informational support. Screen-based education (videos) with information content on advance care decisions that occur in the intensive care unit.
15971666|NCT03099746|Behavioral|Usual Care|Routine decision support practices by the healthcare team. Family meetings, bedside updates, and access to printed or electronic decision aids.
15971667|NCT03099733|Other|text message|Participants will receive text message assessment and tailored intervention messages daily over the 14-day/two-week study period.
15971668|NCT03099720|Drug|Ropivacaine|local anesthetic will be given locally at the site of operation to decrease the level of pain after operation
15971669|NCT03099720|Drug|Placebo|placebo fluid will be given at the site of operation locally
15971670|NCT03099707|Behavioral|Treatment Ambassador|"This multi-component intervention, titled the Treatment Ambassador Program, will target people living with HIV who have not initiated ART within 3 months of testing positive. Our intervention will last for 8 sessions over 8-14 weeks, and will aim to address the three steams of influences on decision-making through a system of patient navigation and support with an assigned partner living with HIV who is trained in motivational interviewing. It will be aimed at addressing barriers to ART initiation identified through our prior qualitative research, as framed through the Theory of Triadic Influence, by addressing the three streams of influences on decision-making through a system of patient navigation and support."
15971671|NCT03099694|Procedure|noninvasive high-frequency ventilation (nHFOV)|NHFOV will be provided by a high frequency ventilator (CNO, Medin, Germany or SLE 5000, UK). NHFOV will be provided via binasal prongs.
15971672|NCT03099694|Procedure|nasal continuous positive airway pressure (nCPAP)|Infants assigned to the NCPAP group will be started on a pressure of 6 cmH2O (range: 6-8 cmH2O) by CPAP system (CNO Medin, Germany, Carefusion, USA)
15971673|NCT03099681|Other|Treatment for Epitheloid Sarcoma|Treatment Epitheloid Sarcoma according the disease guideline
15971674|NCT03099668|Other|Visit to a multidisciplinary clinic|Visit to a multidisciplinary clinic
15971675|NCT03099655|Device|Attain Stability Quad Left Ventricular Pacing Lead|cardiac stimulation
15971676|NCT03099642|Radiation|ultrasound-assisted lumbar puncture|The ultrasound probe type will be selected by the treating pediatric emergency physician who has been trained according to standards outlined below. They will first identify the conus medullaris and make a horizontal marking with a sterile pen on the patient's back. Using a transverse view, they will then identify the midline of the patient's spine (using adjacent spinous processes) and will make 2 vertical skin markings on either side of the probe. Next, they will orient the probe in a longitudinal view to identify the desired vertebral interspace and will make 2 horizontal skin markings on either side of the probe at this level. Finally the 4 lines will be joined together at an intersection point, which will be the predetermined site for puncture attempt.
15971677|NCT03099629|Behavioral|inspiratory muscle training|inspiratory muscle training will start with an intensity of 30% of maximal inspiratory pressure, 15 times/set, 3 sets/day, 7 days/week and training will continue until surgery is scheduled or 2 weeks after the completion of treatment if surgery is not suitable.
15971678|NCT03099616|Drug|Propofol|Propofol delivery will be controlled using automated closed loop anaesthesia delivery system which will control propofol delivery rate to consistent anaesthetic depth (BIS-50) feedback from the patient.
15971679|NCT03099616|Drug|Desflurane|Desflurane delivery will be controlled using a agent specific vaporiser. The dial concentration of the vaporiser will be adjusted to maintain a BIS of 50-55 in the patients.
15971680|NCT03099603|Drug|HTD1801|A small molecular compound for the treatment of primary sclerosing cholangitis
15971681|NCT03099590|Dietary Supplement|kudzu extract, puerarin|Capsules containing 500 mg of a crude kudzu extract (NPI-031, Alkontrol-herbal; Natural Pharmacia International, Burlington, MA) will be used, containing 19% puerarin, 4% daidzin and 2% daidzein, so each capsule contains a total of 25% active isoflavones or 125 mg.
15971682|NCT03099590|Dietary Supplement|Placebo control|Matched sugar beet placebo capsules will serve as placebo.
15971683|NCT03099577|Radiation|radiochemotherapy 1|concurrent radiochemotherapy: radiotherapy dose level 1: 60 Gy at 2 Gy/Fx/d, then 4.8 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly
15971684|NCT03099577|Radiation|radiochemotherapy 2|concurrent radiochemotherapy: radiotherapy dose level 2: 60 Gy at 2 Gy/Fx/d, then 9.6 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly
15971685|NCT03099577|Radiation|radiochemotherapy 3|concurrent radiochemotherapy: radiotherapy dose level 3: 60 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly
15971686|NCT03099577|Radiation|radiochemotherapy 4|concurrent radiochemotherapy: radiotherapy dose level 4: 60 Gy at 2 Gy/Fx/d, then 19.2 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly
15971687|NCT03099577|Radiation|radiochemotherapy 5|concurrent radiochemotherapy: radiotherapy dose level 5: 60 Gy at 2 Gy/Fx/d, then 4.8x5 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly
15971688|NCT03099577|Radiation|radiochemotherapy 6|concurrent radiochemotherapy: radiotherapy dose level 6: 60 Gy at 2 Gy/Fx/d, then 4.8x6 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly
15971689|NCT03099577|Radiation|radiochemotherapy 7|concurrent radiochemotherapy: radiotherapy dose level 7: 60 Gy at 2 Gy/Fx/d, then 4.8x7 Gy at 1.2 Gy/Fx/bid concurrent concurrent chemotherapy :carboplatin area under the curve (AUC) 2; paclitaxel: 45-50 mg/m2, weekly
15971690|NCT03099564|Drug|Pembrolizumab|pembrolizumab 200mg IV every three weeks
15971691|NCT03099564|Device|Y90 radioembolization|The first Y90 radioembolization treatment will be administered one week after the first dose of pembrolizumab. If a second Y90 radioembolization treatment is required for bilobar disease, this should occur within 4 weeks of the initial procedure (between Cycles 2 and 3 of pembrolizumab).
15971692|NCT03099551|Device|Group using manual toothbrush Curaprox 5460 Ultra Soft|Manual toothbrush usage with Bass technique twice a day during 2 minutes
15971693|NCT03099551|Device|Group using sonic toothbrush Edel White|Sonic toothbrush usage twice a day during 2 minutes
15971694|NCT03099538|Drug|Ixekizumab|Subcutaneous injection
15971695|NCT03099525|Other|ILD|This is an observational study without any intervention.
15971696|NCT03099512|Other|SFE|The 'short foot exercise' has been described as a means to isolate contraction of the plantar intrinsic muscles.
15971697|NCT03099512|Other|Exercise|Exercises which improves muscle strength, ROM...
15971767|NCT03099044|Other|Placebo comparator|Subjects consume 2 placebo beverages daily for 10 days. The dose-response controls for volume consumed.
15971698|NCT03099499|Drug|ONC201|ONC201 will be administered at a dose of 625 mg by mouth weekly until disease progression, unacceptable toxicity, or if the patient discontinues for any other reason. Radiologic tumor assessment would be performed at baseline, Cycle 3 Day 1, Cycle 5 Day 1, and at the end of every 3 cycles beyond cycle 5. All patients including those removed from the study due to unacceptable toxicity, will undergo radiologic tumor assessment at the time of discontinuation (End of treatment).
15971699|NCT03099486|Drug|Regorafenib|The dose of Regorafenib is 160 mg PO daily D1-D21 of 28-day cycle or last tolerated dose while on Regorafenib monotherapy.
15971700|NCT03099486|Drug|5-FU|5-FU dose D1 and D15 of 28 day cycle i400 mg/m2 bolus over 10 mins followed by 2400 mg/m2 continuous infusion over 46 hours
15971701|NCT03099486|Drug|Leucovorin|D1 and D15 of 28 day cycle Leucovorin 400 mg/m2 over 2 hours,
15971702|NCT03099473|Other|ocular electroacupuncture|During intervention period, patients will continue to keep medications for primary condition. Patient's skin located in the extraocular muscles projection area is routinely disinfected. A diameter of 0.20 mm and length of 25 mm needle is inserted slowly. Piercing depth is about 20mm. The electropuncture apparatus is used, each group of electrodes are distinguished with different colors of wires to generate current stimulations of current 1.0~1.5 milliampere (mA), voltage 9 volt(V), frequency 1.5 hertz (Hz), and duration of 40 minutes.
15971703|NCT03099473|Other|ocular acupuncture|During intervention period, patients will continue to keep medications for primary condition. Patient's skin located in the extraocular muscles projection area is routinely disinfected. A diameter of 0.20 mm and length of 25 mm needle is inserted slowly. Piercing depth is about 20mm.The duration of intervention is 40 minutes.
15971704|NCT03099473|Other|sham acupuncture|During intervention period, patients will continue to keep medications for primary condition. Patient's skin located in the extraocular muscles projection area is routinely disinfected. A diameter of 0.20 mm and length of 25 mm sham needle set is stick onto insertion area without piercing into the skin. The duration of intervention is 40 minutes.
15971705|NCT03099460|Other|ocular electroacupuncture|During intervention period, patients will continue to keep medications for primary condition. Patient's skin located in the extraocular muscles projection area is routinely disinfected. A diameter of 0.20 mm and length of 25 mm needle is inserted slowly. Piercing depth is about 20mm. The electropuncture apparatus is used, each group of electrodes are distinguished with different colors of wires to generate current stimulations of current 1.0~1.5 milliampere (mA), voltage 9 volt(V), frequency 1.5 hertz (Hz), and duration of 40 minutes.
15971706|NCT03099460|Other|ocular acupuncture|During intervention period, patients will continue to keep medications for primary condition. Patient's skin located in the extraocular muscles projection area is routinely disinfected. A diameter of 0.20 mm and length of 25 mm needle is inserted slowly. Piercing depth is about 20mm.The duration of intervention is 40 minutes.
15971707|NCT03099460|Other|sham acupuncture|During intervention period, patients will continue to keep medications for primary condition. Patient's skin located in the extraocular muscles projection area is routinely disinfected. A diameter of 0.20 mm and length of 25 mm sham needle set is stick onto insertion area without piercing into the skin. The duration of intervention is 40 minutes.
15971708|NCT03099447|Other|ocular electroacupuncture|During intervention period, patients will continue to keep medications for primary condition. Patient's skin located in the extraocular muscles projection area is routinely disinfected. A diameter of 0.20 mm and length of 25 mm needle is inserted slowly. Piercing depth is about 20mm. The electropuncture apparatus is used, each group of electrodes are distinguished with different colors of wires to generate current stimulations of current 1.0~1.5 milliampere (mA), voltage 9 volt(V), frequency 1.5 hertz (Hz), and duration of 40 minutes.
15971709|NCT03099447|Other|ocular acupuncture|During intervention period, patients will continue to keep medications for primary condition. Patient's skin located in the extraocular muscles projection area is routinely disinfected. A diameter of 0.20 mm and length of 25 mm needle is inserted slowly. Piercing depth is about 20mm.The duration of intervention is 40 minutes.
15971710|NCT03099447|Other|sham acupuncture|During intervention period, patients will continue to keep medications for primary condition. Patient's skin located in the extraocular muscles projection area is routinely disinfected. A diameter of 0.20 mm and length of 25 mm sham needle set is stick onto insertion area without piercing into the skin. The duration of intervention is 40 minutes.
15971711|NCT03099434|Behavioral|Facebook App|This web-based mobile application allows candidates to write a simple and effective story to share with their previously built network on Facebook to help share their story and identify a potential live donor.
15971712|NCT03099434|Behavioral|Live Donor Champion + Facebook App|"A Live Donor Champion (LDC) is a friend, family member, or community member who serves as an advocate for the candidate in their pursuit of live donation. The investigators have developed a six-month program that provides education and advocacy training to waitlist candidates and their LDCs."
15971713|NCT03099421|Procedure|Prostatic Artery Embolization|The procedure is performed with the patient under local anaesthetic and if necessary sedation. We will be using a percutaneous transfemoral approach, super-selective catheterisation of small prostatic arteries is carried out using microcatheters. Embolisation will be done using microspherical embolic material.
15971714|NCT03099408|Drug|Metronidazole Oral|Oral metronidazole 400 mg BID for 7 days at first month.
15971715|NCT03099408|Drug|"Metronidazole and Lactobacillus"|Oral metronidazole metronidazole 400 mg BID for 7 days at first month and Lactobacillus vaginal suppositories for 10 days at first month,second month and third month.
15971716|NCT03099382|Biological|SHR-1210|Subjects receive SHR-1210 intravenous at the dose 200mg on Day 1 every 2 weeks
15971717|NCT03099382|Drug|Docetaxel|Subjects receive Docetaxel intravenous at the dose 75mg/m2 on Day 1 every 3 weeks
15971718|NCT03099382|Drug|Irinotecan|Subjects receive Irinotecan intravenous at the dose 180mg/m2 on Day 1 every 2 weeks
15971719|NCT03099369|Behavioral|Daily Step-based Exercise|A 12-week step-based exercise prescription with the eventual goal of walking at least 5,000 steps a day.
15971720|NCT03099369|Behavioral|Symptom-based Exercise|A 12-week symptom-based exercise prescription adapted from clinical practice guidelines.
15971721|NCT03099369|Other|Fitbit Fitness Monitor|Used by the experimental group to assess outcome and to guide exercise therapy; used by the active comparator group to assess outcome only
15971722|NCT03099356|Drug|Cyclophosphamide|Cyclophosphamide 100 mg, PO, days 1-5 and 15-19
15971723|NCT03099356|Drug|Sirolimus|Sirolimus 4 mg, PO, days 1-28
15971724|NCT03099343|Behavioral|Location-based Tailored Messaging|The mobile application works by providing tailored messages targeted to participant locations that can help individuals to choose lower sodium foods.
15971725|NCT03099330|Drug|TQ-B3139|TQ-B3139 p.o. qd
15971726|NCT03099317|Other|Sinew acupuncture|Sinew acupuncture: subject will sit on chair with knee joint flexion with a most comfortable angle nearest to 90 degrees. Acupoints (1-2cm away from the point of tenderness or pain) near the knee will be punctured through the skin by using sterile needles of size 0.30mm × 40mm at the angle of 0-10 degrees pointing along the pain direction and meridian sinew. Immediately, needles will be retreated back just under the skin and inserted 10mm-20mm forward smoothly with minimal pain sensation. Walking and stepping will be advised and governed during acupuncture. The acupoint will be covered with non-allergic bandages to ensure sufficient blinding to the subject. The treatment will last 20 minutes for each session.
15971727|NCT03099317|Other|Sham acupuncture|Sham acupuncture: subject will receive the same procedures as the sinew acupuncture without penetrating the skin. The needle will be used to puncture on the acupoint slightly without passing through the skin. The acupoint will be covered with non-allergic bandages to ensure sufficient blinding to the subject.
15971728|NCT03099304|Drug|Ruxolitinib cream|Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
15971729|NCT03099304|Drug|Vehicle cream|Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
15971730|NCT03099291|Biological|RSV D46/NS2/N/ΔM2-2-HindIII Vaccine|10^5 plaque-forming units (PFUs); administered as nose drops
15971731|NCT03099291|Biological|Placebo|Administered as nose drops
15971732|NCT03099278|Drug|Ezetimibe|Ezetimibe 20 mg oral daily
15971733|NCT03099265|Drug|neoadjuvant mFOLFIRINOX|Patients will receive 8 cycles of mFOLFIRINOX every 2 weeks. mFOLFIRINOX will be dosed as follows: Oxaliplatin 85 mg/m2, followed by folinic acid 400 mg/m2 infused over 120 minutes and irinotecan 135 mg/m2 infused over 90 minutes, followed by 5-fluorouracil 300 mg/m2 IV bolus, followed by 2,400 mg/m2 continuous infusion for 46 hours. Levoleucovorin may be substituted for folinic acid at a dose of 200 mg/m2 infused over 120 minutes.
15971734|NCT03099265|Drug|Stereotactic body radiotherapy (SBRT)|Stereotactic body radiotherapy (SBRT) will be delivered to the primary tumor and any adjacent involved nodes to 33 Gy in 5 fractions over the course of 2 weeks, and within 4 weeks of chemotherapy.
15971735|NCT03099252|Other|Parent-targeted BSweet2Babies video|The video portrays three babies having blood tests while being i) BF, ii) held SSC with the mother, and iii) receiving sucrose. The calming effects of these strategies are powerfully portrayed. Voice-over in user-friendly language explains how parents can help their babies by partnering with clinicians to use these strategies. As per the definition of patient-targeted and mediated interventions, this video is: i) patient (parent)-targeted, as it actively engages parents to improve their knowledge, positively affect their experience (during newborn screening), change their behavior and their baby's outcomes; ii) patient-mediated, as the video enables parents to change health professional behavior.
15971736|NCT03099239|Biological|hCT-MSC infusion|hCT-MSCs are a product of allogeneic cells manufactured from digested umbilical cord tissue that is expanded in culture, cryopreserved and banked.
15971737|NCT03099226|Drug|Placebo|Placebo blue hard gelatine capsules
15971738|NCT03099226|Drug|BIA 5-453|Etamicastat (BIA 5-453) blue hard gelatine capsules - 50 Strength (mg)
15971739|NCT03099213|Drug|RAMIPRIL HOE498|Pharmaceutical form:Tablet Route of administration: Oral
15971740|NCT03099200|Other|No Intervention|
15971741|NCT03099187|Drug|Pirfenidone|Pirfenidone 267 mg capsules three times in a day.
15971742|NCT03099187|Drug|Placebo|Matching placebo capsules three times in a day.
15971749|NCT03099161|Drug|preladenant|Administered as an oral capsule BID on Days 1 through 21 of each 21-day cycle
15971750|NCT03099161|Biological|pembrolizumab|Administered as IV infusion on Day 1 of each 21-day cycle
15971751|NCT03099148|Drug|LY3337641 (R)|Administered orally
15971752|NCT03099148|Drug|LY3337641 (T1)|Administered orally
15971753|NCT03099148|Drug|LY3337641 (T2)|Administered orally
15971754|NCT03099135|Drug|No Treatment|No treatment will be given tp participants during this follow-up study of previous phase II and Phase III in which they have received Odalavir and AL-335 with or without Simeprevir.
15971755|NCT03099122|Biological|Rabbit Anti-thymocyte Immunoglobulin|"Pharmaceutical form: creamy-white powder
~Route of administration: intravenous"
15971756|NCT03099122|Drug|Tacrolimus|"Pharmaceutical form: tablet
~Route of administration: oral"
15971757|NCT03099122|Drug|Methylprednisolone|"Pharmaceutical form: powder
~Route of administration: intravenous"
15971758|NCT03099122|Drug|Mycophenolate mofetil|"Pharmaceutical form: capsule
~Route of administration: oral"
15971759|NCT03099122|Drug|Mycophenolate Na|"Pharmaceutical form: capsule
~Route of administration: oral"
15971760|NCT03099122|Drug|prednisone|"Pharmaceutical form: tablet
~Route of administration: oral"
15971761|NCT03099109|Drug|LY3321367|Administered IV
15971762|NCT03099109|Drug|LY3300054|Administered IV
15971763|NCT03099096|Drug|Mepolizumab|It is a clear to opalescent, colorless to pale yellow sterile solution for SC injection, supplied in a single-use, prefilled syringe containing 100 mg/mL mepolizumab with sodium phosphate, citric acid, sucrose EDTA and polysorbate 80 within an autoinjector.
15971764|NCT03099070|Behavioral|Stress|Trier Social Stress Test
15971765|NCT03099070|Other|Fasting|12-hour fasting prior to study visit
15971766|NCT03099057|Other|follow-up of patients after interventional rhythm operation|The follow-up will take place at 3 months postoperatively, then at 1 year and then annually for 5 years.
15971768|NCT03099044|Other|Single Active dose|Subjects consume 1 placebo + 1 Active beverages daily for 10 days. The dose-response controls for volume consumed.
15971769|NCT03099044|Other|Double Active dose|Subjects consume 2 Active beverages daily for 10 days. The dose-response controls for volume consumed.
15971770|NCT03099031|Drug|Tinzaparin|Subcutaneous injection of 175 IU/kg once daily for 6 months
15971771|NCT03099018|Diagnostic Test|Sofia Strep A FIA|Patients who presented with sore throat will be performed throat swab for the new fluorescent immunoasssay (Sofia Strep A FIA), for a standard RADT (Alere Testpack Strep A) and for culture and backup PCR in case of discrepant results.
15971772|NCT03099005|Drug|Cannabis|vaporization of cannabis
15971773|NCT03098992|Device|Fotona Dynamis Er:YAG Laser System|Treatment of urodynamic proven stress urinary incontinence using the Fotona Dynamis Er:YAG Laser System in the active arm
15971774|NCT03098992|Device|Fotona Dynamis Er:YAG Laser System with sham handpience|Sham treatment with a sham handpiece and parameter presentations masked
15971775|NCT03098979|Drug|Neladenoson bialanate (BAY1067197)|5 mg orally once daily for 20 weeks
15971776|NCT03098979|Drug|Neladenoson bialanate (BAY1067197)|10 mg orally once daily for 20 weeks
15971777|NCT03098979|Drug|Neladenoson bialanate (BAY1067197)|20 mg orally once daily for 20 weeks
15971778|NCT03098979|Drug|Neladenoson bialanate (BAY1067197)|30 mg orally once daily for 20 weeks
15971779|NCT03098979|Drug|Neladenoson bialanate (BAY1067197)|40 mg orally once daily for 20 weeks
15971780|NCT03098979|Drug|Placebo|Orally once daily for 20 weeks
15971781|NCT03098953|Drug|Loteprednol Etabonate|one drop per eye for each eye
15971782|NCT03098940|Drug|Chewing Gum|During the study healthy subjects will receive single doses of the various strengths of dronabinol
15971783|NCT03098927|Behavioral|Motor imagery training|Motor imagery training
15971784|NCT03098914|Other|Cohort Study； pathogen； clinical features|Cohort Study； pathogen； clinical features
15971785|NCT03098901|Diagnostic Test|Tc99m-labeled pyrophosphate scan|Intravenous injection of Tc99m-labeled pyrophosphate with consecutive whole body scan using gamma ray scanner for assessment of radioactive uptake in the heart. The results of the scan will be evaluated by a specialist in the field. The uptake will be graded using Perugini scale (0- no uptake, 1- uptake in heart less intense than in bones, 2-uptake in heart as intense as in bones, 3-uptake in heart more intense than in bones).
15971786|NCT03098888|Procedure|bronchoalveolar lavage|bronchoalveolar lavages performed for cytological assessment in critically ill patients with lung diseases, intubated or not
15971787|NCT03098875|Drug|Sevoflurane|General anesthesia using sevoflurane as a hypnotic agent
15971788|NCT03098875|Drug|Propofol|General anesthesia using propofol as a hypnotic agent
15971789|NCT03098875|Drug|Remifentanil|General anesthesia using remifentanil as an analgesic.
15971790|NCT03098849|Other|Buteyko Breathing Technique|Patients are trained in various exercises aiming at breath reduction and breath control as introduced by Dr. K. Buteyko
15971791|NCT03098836|Drug|ARN-509|240 mg orally daily
15971792|NCT03098836|Drug|Abiraterone Acetate|1000 mg orally daily
15971793|NCT03098836|Drug|Prednisone|5 mg orally twice daily (for total daily dose 10 mg)
15971794|NCT03098823|Drug|RAYOS|FDA approved RAYOS for indication of fatigue in Lupus.
15971795|NCT03098823|Drug|Prednisone|FDA approved corticosteroid frequently used for SLE.
15971796|NCT03098810|Drug|Zinc sulphate|Oral syrup zinc sulphate
15971797|NCT03098810|Other|Placebo|Oral syrup placebo
15971798|NCT03098797|Drug|Elamipretide|40 mg daily subcutaneous injection for 12 weeks
15971799|NCT03098784|Other|Exposure to aircraft exhaust|The exposed group is made up of Air France personnel mainly working in physical proximity to the runways of the Marseille Marignane or Parisian airports. These people are subject to direct exposure to exhaust from aircraft engines.
15971800|NCT03098784|Other|Non exposure to aircraft exhaust|The non-exposed group is made up of Air France personnel working mainly inside buildings at the Marseille Marignane or Parisian airports. These people are not subject to direct exposure to exhaust from aircraft engines.
15971801|NCT03098771|Procedure|the cell transplantation group|Patients with atherosclerotic lower limb ischemia will be randomly assigned to the cell transplantation group, which peripheral blood CD34+ cells transfected with ActiveMax® recombinant human vascular endothelial growth factor 165 (VEGF165) gene will be transplanted into the muscles of ischemic limbs in elderly patients with atherosclerotic lower limb ischemia.
15971802|NCT03098771|Drug|the control group|Patients with atherosclerotic lower limb ischemia will be randomly assigned to the control group, which 9% physiological saline will be injected into the muscles of ischemic limbs.
15971803|NCT03098745|Device|Omafilcon A|contact lens
15971804|NCT03098745|Device|Somofilcon A|contact lens
15971805|NCT03098745|Device|Omafilcon A - Proclear (PC)|contact lens
15971806|NCT03098732|Device|Magnetically Enhanced Diffusion (MED)|Treatment of Acute Ischemic Stroke with IV tPA and the adjunctive Magnetically Enhanced Diffusion (MED) System Procedure.
15971807|NCT03098732|Device|MED Workstation Magnet Sham Control|Treatment of Acute Ischemic Stroke with IV tPA and Sham use of the MED Workstation only, without the injection of MED MicroBeads.
15971808|NCT03098719|Behavioral|Active Mobility|see detailed discription
15971809|NCT03098706|Procedure|Procedure control: normothermia|Temperature will be maintained between 36.5° and 37.5°C in the control group. In case of temperature superior to 37.5°C or inferior to 36.5°C, a pharmaceutical treatment and/or active cooling or warming will be introduce to maintain temperature between the range of 36.5 - 37.5°C.
15971810|NCT03098706|Procedure|Procedure active|Therapeutic hypothermia ie targeted controlled temperature between 34° and 35°C will be induced in the active group. Usual method of controlled temperature will be used in ICU: internal active method or external active method.
15971811|NCT03098693|Behavioral|HIV Self-Testing|Access to home-based HIV self-testing kits for stable couples.
15971812|NCT03098693|Behavioral|Immediate Access to ART for HIV infected couple members|Immediate access to ART for HIV infected couple members (per current Tanzanian standard of care).
15971813|NCT03098693|Behavioral|Access to PrEP for HIV uninfected couple members|Access to PrEP for HIV uninfected couple members.
15971814|NCT03098680|Drug|Albuterol Sulfate|see arm/group descriptions
15971815|NCT03098680|Drug|Nicardipine Hydrochloride|see arm/group descriptions
15971816|NCT03098680|Drug|Dobutamine Hydrochloride|see arm/group descriptions
15971817|NCT03098680|Drug|Phenylephrine Hydrochloride|see arm/group descriptions
15971818|NCT03098680|Drug|Verapamil Hydrochloride|see arm/group descriptions
15971819|NCT03098680|Drug|Phentolamine Mesylate|see arm/group descriptions
15971820|NCT03098680|Drug|Placebo|see arm/group descriptions
15971821|NCT03098667|Device|LMA Protector|After induction of general anesthesia, the LMA Protector will be applied for airway management. The size of the laryngeal mask will be chosen according to the manufacturer's instructions. Lubricant gel will be applied to the dorsal side of the mask to ease the insertion to the oropharynx. The cuff of the mask will be filled with air by syringe until the indication of the integrated cuff pressure indicator is appropriate according to the manufacturer (green indication). If the indication changes during surgery, air will be added or removed accordingly. If the ventilation of the patient is inadequate at the beginning or anytime during the operation, the mask will be removed and the patient will be intubated.
15971822|NCT03098667|Device|Endotracheal tube|After induction of general anesthesia, the endotracheal tube be applied for airway management. The size of the tube will be 7.5 for female and 8.5 for male patients. The cuff of of the tube will be filled with 10ml air.
15971823|NCT03098654|Diagnostic Test|Blood glucose and blood pressure testing|Diabetes will be assessed using a 6-question risk assessment on a 10-point scale (based on a field-tested and culturally adapted International Diabetes Federation formula on DM risk factors and symptoms) and a random blood glucose test with a portable finger stick glucose monitor. Those with either: (1) a risk score of 5 or more, or (2) a random blood glucose with a value greater than 140 mg/dl, will be asked to return after fasting for at least 8 hours to have a fasting glucose test taken. Blood pressure will be assessed using a portable battery operated automatic BP cuff. The BP test will include three values taken at least 5-minutes apart and the 3 will be averaged to determine the final value.
15971824|NCT03098654|Behavioral|Diet and lifestyle counseling|All participants with elevated glucose or BP will receive personalized lifestyle counseling by trained counselors informed by lab results and that includes education on diabetes, hypertension, dietary assessment and recommendations, advice on physical activity, and the need to regularly monitor their glucose, BP, and adjust their diet, activity level, as needed. Personalized risk reduction plans will be negotiated with the client during their scheduled visits.
15971825|NCT03098654|Drug|DM/HTN medications as needed|Subjects will receive DM or HTN medications prescribed by the CTC clinician as needed.
15971826|NCT03098641|Procedure|pelvic organ prolapse repair|Surgery to repair pelvic organ prolapse through the vagina using stitches with the addition of surgical mesh.
15971827|NCT03098628|Biological|PCV Vaccine|PCV vaccination
15971828|NCT03098615|Drug|Jublia (Efinaconazole 10% Topical Solution)|Efinaconazole 10% Topical Solution will be applied to the great toenail with the DLSO and dermatophytoma.
15971829|NCT03098589|Drug|Revlimid|Revlimid
15971830|NCT03098576|Other|Matched targeted drug treatment|Matching a specific genetic abnormality (i.e. mutation) with the appropriate targeted drug.
15971831|NCT03098576|Other|Unmatched standard of care|"All patients with either no identified mutation or no available matching treatment but undergoing a systemic treatment will be enrolled in the control group."
15971832|NCT03098563|Drug|Blinded study medication|Blinded study medication: This is a double-blind within-subject Phase II trial. Study medications will remain blinded. Participants may receive a dose of medication from one or more of the following categories: prescription stimulants, prescription benzodiazepines, prescription opioids, prescription cannabinoids, over-the-counter medications or placebo (sugar pill). All subjects will serve as their own control. Study medication administration will be randomized within each participant.
15971833|NCT03098550|Biological|Nivolumab|Specified dose on specified days
15971834|NCT03098550|Biological|Daratumumab|Specified dose on specified days
15971835|NCT03098537|Drug|enteral nutrition + proton pump inhibitor|Critically ill patients receiving any form of enteral nutrition will be included into the study. The patients will be randomized either enteral nutrition only group or enteral nutrition and proton pump inhibitors group. This group will receive enteral nutrition and proton pump inhibitor
15971836|NCT03098537|Other|enteral nutrition only|Critically ill patients receiving any form of enteral nutrition will be included into the study. The patients will be randomized either enteral nutrition only group or enteral nutrition and proton pump inhibitors group. This group will receive only enteral nutrition.
15971837|NCT03098524|Procedure|Low tidal volume ventilation (LTV arm)|During cardiopulmonary bypass, mechanical ventilation is maintained with settings described above.
15971838|NCT03098524|Procedure|No ventilation (noV arm)|During cardiopulmonary bypass, no mechanical ventilation is performed.
15971839|NCT03098524|Procedure|Lung recruitment manoeuver|"An insufflation with positive end-expiratory pressure +30 cmH20 during 5 seconds.
~At the end of cardiopulmonary bypass, in the operative room. And after transfer to the ICU (intensive care unit)."
15971840|NCT03098511|Diagnostic Test|Neurological Diagnostic Evaluation|"Clinical Data:
~Demographic data
~Daily data (clinical exams, laboratory data)
~Drug administration
~Additional clinical or ancillary neurological determination test
~Diagnostic Intervention:
~CT-Perfusion
~CT-Angiography reconstructions
~Reference Standard:
~- Clinical Neurological Exam
~Blood Samples (Pharmacokinetics, Inflammatory & Nanovesicles Parameters):
~At the time of patient enrolment
~6 hours after patient enrolment
~At the time of the clinical neurological exam
~Secondary Outcome measures at 6 months:
~extended Glasgow Outcome Scale (GOSe)
~modified Rankin Scale (mRS)"
15971841|NCT03098498|Procedure|Subgingival Debridement|Removal of subgingival bacterial biofilms and subgingival calculus from periodontal lesions
15971842|NCT03098485|Drug|Levofloxacin|5 days of levofloxacin administration
15971843|NCT03098485|Drug|Azithromycin|5 days of azithromycin administration
15971844|NCT03098485|Drug|Cefpodoxime|5 days of cefpodoxime administration
15971845|NCT03098459|Other|Non-interventional observational prospective cohort study|Non-interventional observational prospective cohort study
15971846|NCT03098446|Behavioral|Prolonged sitting with exercise|Subjects will have a 2-day control period during which step count and diet will be controlled for and recreated for the other trial. Following this 2-day period, they will undergo the prolonged sitting trial with the acute bout of exercise on day 4. Day 5 will consist of the lipid tolerance test to determine the ability of the body to clear triglycerides.
15971847|NCT03098446|Behavioral|Prolonged sitting without exercise|Subjects will have a 2-day control period during which step count and diet will be controlled for and recreated for the other trial. Following this 2-day period, they will undergo the prolonged sitting trial, but will not be asked to complete an acute bout of exercise on day 4. Day 5 will consist of the lipid tolerance test to determine the ability of the body to clear triglycerides.
15971848|NCT03098433|Drug|Liothyronine|Single dose
15971849|NCT03098433|Drug|Levothyroxine|Active comparator
15971850|NCT03098433|Drug|Placebos|Placebo
15971851|NCT03098420|Drug|2mg Dexamethasone|0.5 mL (2mg) of dexamethasone and 0.5 ml of normal saline
15971852|NCT03098420|Drug|4mg Dexamethasone|1 mL (4mg) of dexamethasone
15971853|NCT03098420|Drug|Ropivacaine (TAP blocks)|20mL of 0% ropivacaine with 20mL of 0.5% ropivacaine
15971854|NCT03098420|Drug|Morphine|
15971855|NCT03098420|Drug|Bupivacaine Hydrochloride|
15971856|NCT03098420|Drug|Normal saline 1ml|1.0 ml of normal saline split between 2 sites with standard intrathecal bupivacaine and morphine
15971857|NCT03098420|Drug|Normal saline 0.5ml|0.5 ml of normal saline split between 2 sites with standard intrathecal bupivacaine and morphine
15971858|NCT03098407|Drug|Buprenorphine|This is a pilot study to establish the feasibility and acceptability of a randomized comparative effectiveness clinical trial comparing office-based buprenorphine vs. federally licensed methadone treatment programs for OD pregnant women.
15971859|NCT03098407|Drug|Methadone|This is a pilot study to establish the feasibility and acceptability of a randomized comparative effectiveness clinical trial comparing office-based buprenorphine vs. federally licensed methadone treatment programs for OD pregnant women.
15971860|NCT03098394|Device|Cepheid Xpert CT/NG Rapid Turnaround Test|This diagnostic test will be used to help clinicians determine the need for antibiotic prescriptions in patients with a suspected sexually tract infection.
15971861|NCT03098394|Device|Polymerase chain reaction (PCR)|This is the standard of care for diagnosis of a suspected sexually transmitted infection.
15971862|NCT03098368|Drug|Rotigotine|
15971863|NCT03098368|Drug|Placebo|Placebo of rotigotine patch
15971864|NCT03098355|Biological|4SCAR19/22 T cells|CD19/CD22-targeted 4th Generation CAR-T Cell (4SCAR19/22)
15971865|NCT03098355|Drug|Interleukin-2|Interleukin-2 of 250,000iu/m^2 every other day for 2 weeks and then rest for 2 weeks for up to 6 months.
15971866|NCT03098342|Procedure|Methylene blue-mediated photodynamic therapy|Using the 2% MB aqueous solution as a photosensitiser. After the rest period, the lesion was immediately illuminated with incoherent red light (peak emission spectrum at 630-640 nm)
15971867|NCT03098342|Drug|Amorolfine 5% Nail Lacquer|Patients will be detailed instruction regarding the use of 5% Amorofine Nail Lacquer (Loceryl®) as its recommended protocol.
15971868|NCT03098329|Other|Ct/GC screening|Men aged 15-24 years old will be tested for chlamydia and gonorrhea at community based venues; positive men and their sexual partners will be offered expedited treatment at participating pharmacies; positive men will be asked to be rescreened for Ct/GC at 3 months post treatment.
15971869|NCT03098316|Diagnostic Test|Metabolomics analysis of patient samples|Metabolomics analysis of patient samples by mass spectrometry and nuclear magnetic resonance spectroscopy.
15971870|NCT03098290|Procedure|Catheter-based endovascular revascularization|(e.g. PTA-alone, Bare-Metal or Drug-Eluting-Stent, Covered Stent, Atherectomy, Mechanical Thrombectomy, Scoring Ballon, Cutting Ballon)
15971871|NCT03098290|Procedure|Bypass-Surgery|Venous or alloplastic or comparable Bypass
15971872|NCT03098290|Procedure|Endarterectomy|Endarterectomy, Patchplasty
15971873|NCT03098277|Device|Accelerometer|Wear Microsoft Band 2
15971874|NCT03098277|Other|Laboratory Biomarker Analysis|Correlative studies
15971875|NCT03098277|Other|Physical Activity Measurement|Perform physical activities recorded by Microsoft Kinect 2
15971876|NCT03098277|Behavioral|Telephone-Based Intervention|Complete PRO questionnaires
15971877|NCT03098264|Procedure|Simultaneous surgery|Simultaneous surgery in complicated hepatolithiasis
15971878|NCT03098264|Procedure|staged surgery|staged surgery in complicated hepatolithiasis
15971879|NCT03098251|Procedure|3D typing|typing the patient with 3D typing system and give specific treatment
15971880|NCT03098251|Procedure|routine typing|typing the patient with routine typing system and give specific treatment
15971881|NCT03098238|Biological|Biological sample|Biological sampling of two citrate tubes (18 ml) during a normal blood
15971882|NCT03098225|Radiation|Orbital radiotherapy|A high-voltage linear accelerator will be used and a cumulative radiation dose of 20 Gy will be delivered to each eye in 10 fractionated doses over a period of 2 weeks. All patients will be treated in both eyes.
15971883|NCT03098225|Drug|Methylprednisolone|Methylprednisolone pulse therapy for 12 weeks as follows: 500 mg IV once weekly for 6 weeks, then 250 mg IV once weekly for a further 6 weeks. Cumulative dose 4.5 g.
15971884|NCT03098212|Other|Aromatherapy|On the day of admission for labor. Pregnant women select type of essential oil. Aroma diffuser is used during labor. Pain score was record during latent, early active and late active phase.
15971885|NCT03098199|Drug|300IU Gonal-F|<1.5 AMH group
15971886|NCT03098199|Drug|150IU Menopur|<1.5 AMH group
15971887|NCT03098199|Drug|225IU Gonal-F|1.6-2.5 AMH group
15971888|NCT03098199|Drug|75IU Menopur|1.6-2.5 AMH group 2.6-6.9 AMH group >7.0 AMH group
15971889|NCT03098199|Drug|150IU Gonal-F|2.6-6.9 AMH group
15971890|NCT03098199|Drug|75IU Gonal-F|>7.0 AMH group
15971891|NCT03098186|Behavioral|Intervention SMS|The active treatment will consist of SMS that are aimed to modified behavioral factors associated with poor adherence to cardiovascular medications used in secondary prevention. The SMS will be delivered daily during the first month, increasing one day of interval for each week during the second month , and weekly thereafter until end of month 12th. In addition, they will receive SMS thanking for their participation in the trial, reminders of trial appointment and informing if they have changed contact details. The frequency of this SMS will be monthly.
15971892|NCT03098186|Behavioral|Control SMS|Participants will only receive the SMS thanking for their participation in the trial, reminders of trial appointment and informing if they have changed contact details. The frequency of this SMS will be monthly.
15971893|NCT03098173|Procedure|Early colonoscopy|Performance of prepared colonoscopy within 24 h of arrival
15971894|NCT03098173|Procedure|Elective colonoscopy|Performance of prepared colonoscopy between 24 and 96 h after arrival
15971895|NCT03098160|Drug|Evofosfamide|Evofosfamide given on day one and in combination with Ipilimumab on day 8 of the first two cycles, Ipilimumab given alone on day 8 of last two cycles for a total of four 21 day dosing cycles.
15971896|NCT03098160|Drug|Ipilimumab|Evofosfamide given on day one and in combination with Ipilimumab on day 8 of the first two cycles, Ipilimumab given alone on day 8 of last two cycles for a total of four 21 day dosing cycles.
15971897|NCT03098134|Behavioral|Behavior Therapy|Virtual Reality and Video based Exposure Therapy
15971898|NCT03098134|Other|Health Education|Video based health education covering common myths and false believes about dental surgeries
15971899|NCT03098121|Drug|grazoprevir and elbasvir|For patients with chronic genotype 1a, with or without resistance associated variant (RAV) of NS5A, are expected to receive grazoprevir and elbasvir in a fixed-dose combination tablet once daily with ribavirin for 16 weeks, and for patients with chronic genotype 1b are expected to receive grazoprevir and elbasvir in a fixed-dose combination tablet once daily for 12 weeks.
15971900|NCT03098108|Radiation|Concurrent chemo-proton therapy|Proton therapy with simultaneous integrated boost technique Gross tumor volume 70.4 gray (Gy)/ 16 fractions and clinical target volume 44.8 Gy/16 fractions Capecitabine twice a day 825 mg/body square meter
15971901|NCT03098095|Behavioral|Physical Activity|Moderate physical activity
15971902|NCT03098082|Device|Actim Pancreatitis|Actim Pancreatitis (Medix Biochemica) is a urine trypsinogen-2 dipstick test (UTDT) that uses trypsinogen-2 as a biomarker for acute pancreatitis.
15971903|NCT03098056|Other|PROG2|"Nutritional Supplements to be administered:
~Protein Shakes: one shake po twice daily
~Phytosterol supplement: one capsule po twice daily
~Cinnamon: one tablet twice daily
~Fiber supplement; one shake twice daily
~Antioxidant supplement: 2 capsules daily with dinner
~Fish Oil supplement: 1 capsule twice daily with food
~Probiotic supplement: 1 capsule twice daily with food"
15971904|NCT03098030|Biological|Dinutuximab|Dinutuximab injection, for intravenous (IV) use
15971905|NCT03098030|Drug|Irinotecan|Irinotecan injection, IV infusion
15971906|NCT03098030|Drug|Topotecan|Topotecan for injection
15971907|NCT03098017|Other|Short pasta (dry)|50g available carbohydrate portion of penne (~71g uncooked) will be cooked according to package instructions and served with 500mL water
15971908|NCT03098017|Other|Long pasta (dry)|50g available carbohydrate portion of spaghetti (~71g uncooked) will be cooked according to package instructions and served with 500mL water
15971909|NCT03098017|Other|Couscous|50g available carbohydrate portion of couscous (~70g uncooked) will be cooked according to package instructions and served with 500mL water
15971910|NCT03098017|Other|Glucose|50g available carbohydrate portion of glucose monohydrate (~55g) will be dissolved in 500mL water
15971911|NCT03098004|Other|e-Cigarette|Participants will self-administer an experimenter-provided e-cigarette.
15971912|NCT03097991|Behavioral|Focused Coparenting Consultation|Six 90-minute sessions completed within 10 weeks address importance of coparenting for child development; overcoming challenges to coparenting collaboratively; anger and conflict management and communication skills. Parents develop a coparenting plan to support one another's involvement as parents to the baby. A 90-minute booster session one month after the baby's birth reinforces lessons learned in the 6-session intervention.
15971913|NCT03097978|Device|Commercial system|Transhumeral amputees who have had TMR will use a commercially available prosthesis with an elbow,wrist, and a hand with custom electronics and software for both direct and pattern recognition - based control.
15971914|NCT03097978|Device|RIC arm system|Transhumeral amputees who have had TMR will use the RIC arm system prosthesis with an elbow,wrist, and a hand with custom electronics and software for both direct and pattern recognition - based control.
15971915|NCT03097978|Other|Direct Control|Transhumeral amputees who have had TMR will use either a commercially available prosthesis or the RIC arm system prosthesis with an elbow,wrist, and a hand with custom electronics and software for both direct control.
15971916|NCT03097978|Other|Pattern Recognition|Transhumeral amputees who have had TMR will use either a commercially available prosthesis or the RIC arm system prosthesis with an elbow,wrist, and a hand with custom electronics and software for pattern recognition control.
15971917|NCT03097965|Dietary Supplement|PROGRAM|
15971918|NCT03097965|Other|DIET|
15971919|NCT03097939|Drug|Ipilimumab|1 mg/kg of IV Ipilimumab is admistered over 90 minutes every 6 weeks
15971920|NCT03097939|Drug|Nivolumab|3 mg/kg of IV Nivolumab is administered over 30 minutes every 2 weeks
15971921|NCT03097926|Procedure|Long alimentary limb BPD-DS|BPD-DS with a long strict alimentary limb and a 100-cm common channel.
15971922|NCT03097913|Device|video-stylet|recording each video-stylet endotracheal tube assembly advanced through the selected nasal cavity
15971923|NCT03097900|Drug|Caffeine Citrate|25 patients after elective colorectal surgery will be given 100 mg caffeine citrate orally diluted in 50 ml apple flavored water three times per day starting on the morning of postoperative day 1 after surgery until flatus will occur for the first time or to a maximal period time of 7 days, whichever comes earlier.
15971924|NCT03097900|Other|Water|25 patients after elective colorectal surgery will be given 50 ml apple flavored water three times per day starting on the morning of postoperative day 1 after surgery until flatus will occur for the first time or to a maximal period time of 7 days, whichever comes earlier.
15971925|NCT03097887|Procedure|Omega Loop Gastric Bypass|Bariatric/metabolic surgical procedure
15971926|NCT03097887|Device|Bilitec 2000™|The Bilitec 2000™ device will be used to measure the intensity of biliary reflux in the pouch.
15971927|NCT03097887|Device|V-Loc|Sewing device to perform the anti-reflux sutures.
15971928|NCT03097874|Behavioral|Family Based Treatment|Family Based Treatment of adolescent Anorexia Nervosa
15971929|NCT03097874|Behavioral|Family Based Treatment + Intensive Parental Coaching|Family Based Treatment of adolescent Anorexia Nervosa plus an Intensive Parental Coaching component.
15971930|NCT03097861|Drug|Lubiprostone|24 mcg administered orally BID
15971931|NCT03097861|Drug|Placebo|24 mcg administered orally BID
15971932|NCT03097848|Procedure|RFA|for eligible cases, radiofrequency ablation will be given only.
15971933|NCT03097848|Drug|Sorafenib|for eligible cases, combination treatment with RFA and Sorafenib will be given.That is sorafenib for 2 week,then radiofrequency ablation
15971934|NCT03097835|Drug|Hyper-Diluted Botox|"0.1ml of hyper-diluted Botox® Cosmetic will be administered in the superficial dermis using a 1ml luer lock syringe coupled with a 33g ½ needle"
15971935|NCT03097835|Drug|Topical anesthesia|Topical anesthesia will be bilaterally applied to the mid-face region for 20 minutes
15971936|NCT03097835|Other|0.9% saline solution|0.1ml of 0.9% saline solution will be administered to the side of the face
15971937|NCT03097809|Other|SEEG Recordings|To directly record brain activity from the frontal-limbic circuitry of subjects in the resting state and while they engage in behavioral tasks designed to assess emotional response to negative stimuli and different aspects of impulse control and emotional processing
15971938|NCT03097796|Drug|PUL-042|PUL-042 Inhalation Solution
15971939|NCT03097783|Device|Restylane Perlane Lidocaine|Intradermal injection
15971940|NCT03097770|Biological|anti-CD19/20-CAR vector-transduced T cells|genetically engineered lymphocyte therapy
15971941|NCT03097757|Diagnostic Test|Ultrasound|Ultrasound will be used as a real-time imaging modality to guide forearm fracture reduction.
15971942|NCT03097744|Device|Ceterix NovoStitch|The device allows the physician to place a circumferential compression stitch around meniscal tears. This stitch is placed by passing suture from the tibial side to the femoral side of the meniscus and across the tear. This allows compression across the entire tear surface.
15971943|NCT03097705|Diagnostic Test|OCT (Optical coherence tomography)|RNFL AND IOP MEASUREMNTS
15971944|NCT03097692|Procedure|ischemic preconditioning|ischemic preconditioning will be done after induction and before cardiopulmonary bypass by inflation the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3cycles
15971945|NCT03097692|Drug|Pharmacologic preconditionig|Pharmacologic preconditionig will be attained by sevoflurane anesthesia
15971946|NCT03097679|Device|Pulsar Stent|Percutane transluminal stent angioplasty with a Pulsar Stent of the superficial femoral artery for the treatment of peripheral arterial occlusive disease.
15971947|NCT03097679|Device|LifeStent Flexstar Vascular Stent|Percutane transluminal stent angioplasty with a LifeStent Flexstar Vascular Stent of the superficial femoral artery for the treatment of peripheral arterial occlusive disease.
15971948|NCT03097666|Device|C2 CRYOBALLOON SWIPE ABLATION SYSTEM|"The C2 CryoBalloon Swipe Ablation System (CryoBalloon Swipe) is a cryosurgical device with a nitrous oxide cooled balloon probe that is compatible with upper gastrointestinal diagnostic endoscopes."
15971949|NCT03097653|Other|Decision-aid|Web platform with a multilevel information and an aid for the decision to be taken. The content is splitted in 16-20 screens; each screen contains the answer to a common question (i.e. What is mammography screening? What are its benefits and harms? What results can be expected from the participation to mammography screening? What is breast cancer?). The information covers also controversial topics as overdiagnosis, overtreatment and the disagreement among scientists about harms and benefits' quantification.
15971950|NCT03097653|Other|Standard information|Web platform with a standard brochure. This standard brochure represents a combination of the best information available from the three participate centre' brochures.
15971951|NCT03097640|Other|CHAMP|CHAMP team members visit patients in the ED and on inpatient floors. Along with the patient's input, the team develops an Individualized Care Plan outlining the patient's medical and social history and providing recommendations to other providers on specific aspects of their care. Care plans are reviewed with patients on an individual basis and reviewed periodically by the CHAMP providers. CHAMP-enrolled participants are scheduled for physician and social worker follow-up appointments at the CHAMP clinic; this time is used to provide intensive case management, medical care, and psychosocial support.
15971952|NCT03097627|Drug|ICG Intervention|The intervention to be administered is the drug indocyanine green.
15971953|NCT03097627|Device|Near Infrared Camera|The intervention to detect the administered drug, indocyanine green.
15971954|NCT03097614|Device|TrueTear|The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.
15971955|NCT03097601|Diagnostic Test|ELR+CXCL cytokines levels are of sunitinib response|Demonstrate on independent cohorts of patients that ELR+CXCL cytokines levels are of sunitinib response
15971956|NCT03097588|Drug|Netupitant|300 mg, Given PO, QD
15971957|NCT03097588|Drug|Palonosetron Hydrochloride|0.5 mg, Given PO, QD
15971958|NCT03097588|Other|Questionnaire Administration|Ancillary studies
15971959|NCT03097575|Drug|ICG Intervention|Patients enrolled in the study will undergo injection of near infrared dye indocyanine green around the lung lesion or within the adjacent segmental bronchus at the time of surgery via navigational bronchoscopy, or if not amenable to navigational bronchoscopy injection, then injection will be carried out via a transthoracic approach through the incision or under CT-guidance.
15971960|NCT03097575|Device|Near Infrared Imaging|A near-infrared camera device will be used to detect indocyanine green following injection.
15971961|NCT03097562|Procedure|Femtosecond cataract surgery|Catalys create a circular opening for accessing and removing the cataract.
15971962|NCT03097549|Device|Tät®II Information app|Information about pelvic floor muscle training and bladder training for urgency and mixed urinary incontinence. Information about psychological factors and life style factors that might interfere with incontinence.
15971963|NCT03097549|Device|Tät®II Treatment app|Information about pelvic floor muscle training and bladder training for urgency and mixed urinary incontinence. Information about psychological factors and life style factors that might interfere with incontinence .Exercises for the pelvic floor muscles, for bladder training, and for behaviours of avoidance due to fear of leakage, a statistic function and possibility to set reminders. Individual advices regarding life style factors and training based on findings from the bladder diary and answers in the questionnaires.
15971964|NCT03097536|Other|Luna Bar|Luna Bar (blueberry bliss or lemon zest flavor) product of Clif
15971965|NCT03097523|Device|Custom Thigh Cuff|The aim is to achieve positive and near normal forward arterial vascular blood flow to the lower extremities. Milder cuff pressures up to 65 mmHg will be used to limit venous return to the upper body.
15971966|NCT03097510|Behavioral|Transcendental meditation|The TM technique was taught as a standard 7 step course over 4 consecutive days. Thereafter, subjects attended bimonthly group meetings for more advanced knowledge over the four month intervention period.
15971967|NCT03097497|Other|Physiotherapy re-education program|Physiotherapy Program based on the Re-education of Pre-activation of the Transverse Abdominal Muscle
15971968|NCT03097497|Other|Conventional treatment by GP|Patients will follow the general practitioner's advice including medication if needed
15971969|NCT03097484|Drug|lavender and chamomile essential oils|Our patches are obtained from BioEsse Technologies™. Each patch contains a 50:50 mixture of Lavender and Chamomile essential oils in a 55 microliter standard dose patch. The patches release the aromatherapy over a 2-8 hours period and the diffusion rate of each patch is identical. The back of the patch is layered with a hypoallergenic medical grade adhesive, similar to the material found on ECG leads.
15971970|NCT03097471|Device|BPK-S Integration (Ceramic)|primary total knee endoprosthesis
15971971|NCT03097458|Behavioral|Short-term Counselling for Families|Counselling for Families which can take up to 6 weeks, with regular meetings under the guidance of a trained psychotherapist.
15971972|NCT03097445|Drug|Nicotine patch|mailed 5-week course of Habitrol® transdermal nicotine patches
15971973|NCT03097432|Drug|ORALVAC COMPACT BÄUME|
15971974|NCT03097419|Procedure|Remote post-ischemic conditioning|"A manual sphygmomanometer will be inflated over the brachial artery of the participants' arm that does not have an intravenous catheter actively infusing medications. If both arms are in use, then the participant's non-dominant arm will be used.
~The sphygmomanometer will be inflated to a pressure at least 20 mmHg greater than the participants' last recorded systolic blood pressure.
~The sphygmomanometer will be inflated for 5 minutes then rapidly deflated for 5 minutes, thereby concluding one iteration.
~Five (5) total iterations constitute the treatment.
~The left arm will be preferentially used instead of the right arm, unless the left arm is receiving medication administration."
15971975|NCT03097406|Procedure|Global Unite hemiarthroplasty|A hemiarthroplasty used for complex fractures of the proximal humerus.
15971976|NCT03097406|Procedure|Global Advantage|A total shoulder prosthesis used for osteoarthritis
15971977|NCT03097406|Procedure|Global FX|A hemiarthroplasty used for complex fractures of the proximal humerus.
15971978|NCT03097406|Procedure|Global Unite total shoulder arthroplasty|A total shoulder prosthesis used for osteoarthritis
15971979|NCT03097393|Diagnostic Test|measure Serum procalcitonin level|measuring procalcitonin level
15971980|NCT03097380|Drug|AZD2115|AZD2115
15971981|NCT03097380|Drug|SPIRIVA|Tiotropium
15971982|NCT03097380|Radiation|[11C]AZ13754366|Radioligand
15971983|NCT03097367|Diagnostic Test|bladder neck level on cystography|All patients had investigated by retrograde cystography after LRP and were grouped according their bladder neck position: Level 0: bladder neck at or above the superior margin of the symphysis pubis (SMSP), Level -1: bladder neck at <2 cm below SMSP, and Level -2: bladder neck at >2 cm below SMSP.
15971984|NCT03097354|Other|no intervention/observational survey study design|no intervention/observational survey study design
15971985|NCT03097341|Drug|xisomab 3G3- Dose 1|Participants will receive a single intravenous dose of 0.1 mg/kg xisomab 3G3.
15971986|NCT03097341|Drug|xisomab 3G3-Dose 2|Participants will receive a single intravenous dose of 0.5 mg/kg xisomab 3G3.
15971987|NCT03097341|Drug|xisomab 3G3-Dose 3|Participants will receive a single intravenous dose of 2.0 mg/kg xisomab 3G3.
15971988|NCT03097341|Drug|xisomab 3G3- Dose 4|Participants will receive a single intravenous dose of 5.0 mg/kg xisomab 3G3.
15971989|NCT03097341|Other|Placebo|Participants will receive a single intravenous dose of placebo.
15971990|NCT03097328|Drug|TAK-228|TAK-228 works to inhibit or interfere with cellular functions involved in cell growth and survival. TAK-228 specifically targets a type of protein that can make chemicals that trigger cell growth, including cancer cell growth
15971991|NCT03097315|Drug|4 mg CLS-TA Suprachoriodal Injection|CLS-TA, 40 mg/mL (4 mg in 100 microliters), will be administered as a single injection at 2 timepoints
15971992|NCT03097302|Procedure|Laser keratotomy|Penetrating femtosecond laser assisted keratotomy to treat preexisting corneal astigmatism during lens surgery.
15971993|NCT03097289|Device|Trima Accel system|A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 5 day storage. The entire procedure is painless and should take 90 to 120 minutes.
15971994|NCT03097276|Procedure|blood sample|blood sample will be collected
15971995|NCT03097276|Radiation|CT scan|CT scan
15971996|NCT03097263|Other|Physical Rehabilitation program|
15971997|NCT03097237|Other|Wholegrain rye|Cereal products based on wholegrain rye
15971998|NCT03097237|Other|Refined wheat|Cereal products based on refined wheat
15971999|NCT03097224|Behavioral|Prehabilitation|Four weeks of tele-supervised prehabilitation
15972000|NCT03097211|Drug|Placebo|Placebo capsules. Orally, with 240 mL of potable water.
15972001|NCT03097211|Drug|BIA 6-512|The investigational products consisted of capsules containing BIA 6-512 25 mg, 50 mg, 75 mg, 100 mg. Orally, with 240 mL of potable water.
15972002|NCT03097211|Drug|Madopar® 250|Levodopa/benserazide immediate release tablets 200mg/50mg. Orally, with 240 mL of potable water.
15972003|NCT03097211|Drug|Nebicapone|Nebicapone 150 mg tablets. Orally, with 240 mL of potable water.
15972004|NCT03097198|Other|Plum-blossom Needle|"acupoint selection: Zhengguang 1, Zhengguang 2, GB20, GV14, LI4.
~plum-blossom needle manipulation methods: After the skin has been wiped with 75 % alcohol, plum-blossom needles will be tapped perpendicularly on the skin at the selected acupoints with wrist force and then lifted immediately. Each point will be tapped repeatedly for 20 to 50 times and both sides of cervical vertebra and temporal region, Suprao-infraorbital margin will be tapped repeatedly. Acupuncturists should tap the points gently to make patients feel only a little pain and stop when the skin gets flushed but is not bleeding."
15972005|NCT03097198|Drug|Tropicamide Eye Drops|Instill one drop in both eyes every night before bed.
15972006|NCT03097159|Procedure|Costoclavicular block|Group C for costoclavicular block Group S for supraclavicular block
15972072|NCT03096756|Other|GC4419 IV|infused IV as a single dose of 27 mg (3 mL GC4419 at 9 mg/mL) in 247 mL normal (0.9%) saline, totaling 250 mL, over a 60minute period using a programmable pump.
15972110|NCT03096457|Drug|Paromomycin Sulfate|topical application 2 times a day during 20 days
15972007|NCT03097146|Other|comprehensive multidisciplinary stroke care|"Patients will be treated in the pathological domain. Some of this treatment will be applied by the outpatient clinic itself (i.e. changes in medical secondary prevention or additional prescriptions, social work interventions), whereas most of it will be referred to other providers, if possible in vicinity to the patients' home. In order to ease treatment prescriptions and allow to measure treatment uptake, patients will also enrol in the case management system Ambulanzpartner. This allows the outpatient center to streamline prescription processes and measure uptake of therapies."
15972008|NCT03097133|Drug|Esketamine|Participants will receive intranasal esketamine 84 milligram (mg) two times per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25).
15972009|NCT03097133|Drug|Placebo|Participants will receive intranasal placebo two times per week for 4 weeks (Days 1, 4, 8, 11, 15, 18, 22, and 25).
15972010|NCT03097133|Other|Standard of Care|The standard of care antidepressant treatment (antidepressant monotherapy or antidepressant plus augmentation therapy) will be determined by the treating physician(s) based on clinical judgement and practice guidelines prior to randomization, and the treatment will be initiated on Day 1.
15972011|NCT03097120|Drug|0.625 mg of conjugated equine estrogen|one tablet containing 0.625 mg of conjugated equine estrogen and a placebo tablet daily
15972012|NCT03097120|Drug|0.625 mg of conjugated equine estrogen plus 2.5 mg of medroxyprogesterone acetate|one tablet of 0.625 mg of conjugated equine estrogen plus one tablet 2.5 mg of medroxyprogesterone acetate daily
15972013|NCT03097120|Drug|placebo tablets|two placebo tablets daily
15972014|NCT03097107|Drug|Saroglitazar Magnesium 1 mg|Randomly assigned patients will receive saroglitazar magnesium 1 mg orally once each morning before breakfast for 12 weeks
15972015|NCT03097107|Drug|Saroglitazar Magnesium 2 mg|Randomly assigned patients will receive saroglitazar magnesium 2 mg orally once each morning before breakfast for 12 weeks
15972016|NCT03097107|Drug|Saroglitazar Magnesium 4 mg|Randomly assigned patients will receive saroglitazar magnesium 4 mg orally once each morning before breakfast for 12 weeks
15972017|NCT03097107|Drug|Placebo|Randomly assigned patients will receive placebo orally once each morning before breakfast for 12 weeks
15972018|NCT03097094|Diagnostic Test|Male dog|Male dog extract
15972019|NCT03097094|Diagnostic Test|Female dog|Female dog extract
15972020|NCT03097081|Other|No orthosis|The intervention consists of a deviation of the standard protocol; patients do not receive a post-operative orthosis
15972021|NCT03097081|Device|Orthosis|Patients receive post-operative care following the standard protocol and wear an orthosis for 10-12 weeks.
15972022|NCT03097068|Drug|Lucentis|0.3mg Lucentis
15972023|NCT03097055|Procedure|Traditional Acupuncture|"widely ongoing traditional acupoints in scalp and limbs with traditional deqi manipulation, for stroke patient"
15972024|NCT03097055|Procedure|Minimal Acupuncture|non-traditional acupoints in scalp and limbs, with minimal manipulation
15972025|NCT03097042|Procedure|Embryo transfer any further manipulation|The catheter will be pulled back slowly and without rotation with the plunger still pushed forward
15972026|NCT03097042|Procedure|Embryo transfer with catheter Manipulation|catheter rotation during withdrawal
15972027|NCT03097029|Drug|Pancreatic Enzyme|All subjects will take pancreatic enzymes at a dose appropriate for their weight. Pancreatic enzymes are used to help digest fat and other nutrients.
15972028|NCT03097016|Drug|CC-122|All subjects will receive one 3 mg CC-122 capsule the morning of Day 1 which will be administered in the fasted state.
15972029|NCT03097003|Drug|Apremilast|Psoriasis patients treated with Otezla® (Apremilast) in Belgium
15972030|NCT03096990|Drug|apremilast|Psoriatic arthritis patients treated with Otezla® (apremilast) in Belgium
15972031|NCT03096977|Diagnostic Test|Scale for the assessment and rating of ataxia (SARA)|Clinical evaluation of the manual dexterity through the SARA scale.
15972032|NCT03096977|Device|JAMAR hand dynamometer|"Clinical evaluation of the prehension force using a JAMAR Dynamometer.
~The prehension effort is made with the arm along the body, forearm horizontal, elbow flexed at 90 degrees, wrist in neutral position. The handle of the dynamometer is set to the second notch. The effort required is maximum effort.
~Verbal encouragement is given during four successive tentative: the last three are averaged.
~Each effort will be separated by a rest period of one minute. Interval: 1 min - Repeat: 3 times per hand"
15972033|NCT03096977|Device|Vibratory sensibility testing|"Test carried out using a tuned fork applied to the styloid radial process.
~Position of the evaluated: elbow to the body with forearms horizontal and the wrist in neutral position. Stimulate the tuning fork and apply it to the styloid process of the radius. Ask the patient to say when he no longer feels the vibration.
~Repeat 3 times for each hand."
15972034|NCT03096977|Device|Sermes and Weinstein test|"Instrumental, quantitative method of tactile pressure sensation (dermal contact at constant pressure) using monofilaments. The monofilaments bend when a threshold force is applied to them.There is a kit of 5 monofilaments, each one corresponding to a different functional level.
~Familiarize the patient with the test, eyes open, on a normal healthy side. Determine the level of perception of the healthy side, eyes closed. Start with the finest monofilament. If the answer is negative, go to the next monofilament.
~The monofilaments applications are randomly made in the Wynn Parry areas, 3 times / area for blue and green filaments, then 1 time / zone for others.
~The monofilament must be applied in 1.5 sec, held 1.5 sec, removed in 1.5 sec. The patient must give a verbal response yes when he perceives the contact and the response time must be less than 3 sec."
15972035|NCT03096977|Device|Weber test|"Evaluate the discrimination of 2 motionless points. The tactile discrimination threshold is the smallest distance separating 2 simultaneous stimulations that are located and perceived separately.
~The pressure stops at the whitening of the skin. The patient should specify if he feels one or two spikes.
~To determine the discrimination threshold:
~Perform 10 stimulations of the same spacing in the same area. The smallest interval for which 7 correct answers are obtained is retained as threshold value.
~Perform the test 3 times."
15972036|NCT03096964|Other|Free walking training|The training period begin for both groups, will be comprised of eight weeks of duration, with frequency of three weekly sessions. Volume (session duration in minutes) and intensity (percentage of the heart rate at second threshold ) were the same for both groups, only differing in the use (NW) or not of the poles (FW). Each session will have of the Initial Part or warming-up, the Main Part and Final Part or cooling-down.
15972109|NCT03096470|Procedure|anesthesia|no anesthesia
15972037|NCT03096964|Other|Nordic walking training|The training period begin for both groups, will be comprised of eight weeks of duration, with frequency of three weekly sessions. Volume (session duration in minutes) and intensity (percentage of the heart rate at second threshold ) were the same for both groups, only differing in the use (NW) or not of the poles (FW). Each session will have of the Initial Part or warming-up, the Main Part and Final Part or cooling-down.
15972038|NCT03096951|Behavioral|Prehabilitation|Prehabilitation group will receive a 4-week tele-supervised prehabilitation and a 8-week tele-supervised postoperative rehabilitation.
15972039|NCT03096951|Other|Rehabilitation|Rehabilitation group will receive World Health Organization recommendations on physical activity for health before surgery and a 8-week tele-supervised postoperative rehabilitation.
15972040|NCT03096938|Diagnostic Test|methylation markers screening|Cell-free DNA extraction from plasma samples-Bisulfite conversion of cfDNA-Determination of DNA methylation levels by deep sequencing-Sequencing data analysis
15972041|NCT03096925|Behavioral|Guided self-help|Web-based guided self-help intervention
15972042|NCT03096912|Drug|Ribociclib|Ribociclib Oral 600 mg x 1 a day 21 days on 1 week off in 28 days cycles
15972043|NCT03096899|Other|Observational|Best Supportive Care
15972044|NCT03096886|Behavioral|Computer-Augmented Cognitive Behavioral Therapy|"The model of CCBT, Good Days Ahead (GDA) will be utilized, it has been found that it is not inferior to CBT in MDD treatment efficacy. CCBT participants will complete 9 modules of the GDA program, including 240 minutes of computer training; participants will also meet with a therapist on 6 occasions for a total of 180 minutes of clinician administered cognitive behavioral therapy."
15972045|NCT03096873|Behavioral|Combined Exercise Training|The combined exercise training were consisted with 5 minutes of warm-up, 20 minutes of resistant band exercises (Upper: seated rows, biceps curl, shoulder flexion, elbow flexion, pushup; Lower: hip flexion, hip extension, calf raise, leg press, squat), 30 minutes of treadmill walking, and 5 minutes of cool-down. Intensity of the training was gradually increased from 40-50% heart rate reserve in 1-4 weeks to 60-70% HRR in 9-12 weeks.
15972046|NCT03096860|Other|Active alcohol consumption|Comparison of alcohol consumption vs. placebo consumption and hookah smoking.
15972047|NCT03096860|Other|Placebo consumption|Comparison of alcohol consumption vs. placebo consumption and hookah smoking.
15972048|NCT03096847|Drug|ribociclib|All patients with oestrogen receptor positive advanced or metastatic breast cancer were treated with oral ribociclib at a dose of 600mg daily and oral letrozole 2.5mg daily. The study treatment for an individual patient began on Study Day 1 and continued until 80 weeks after the last patient enrolled the study or until disease progression, unacceptable toxicity, death or early discontinuation from the study for any other reason, whichever occured first.
15972049|NCT03096847|Drug|letrozole|All patients with oestrogen receptor positive advanced or metastatic breast cancer were treated with oral ribociclib at a dose of 600mg daily and oral letrozole 2.5mg daily. The study treatment for an individual patient began on Study Day 1 and continued until 80 weeks after the last patient enrolled the study or until disease progression, unacceptable toxicity, death or early discontinuation from the study for any other reason, whichever occured first.
15972050|NCT03096847|Drug|goserelin|Premenopausal patients additionally received goserelin 3.6mg as monthly implant
15972051|NCT03096834|Biological|AMG334 Pre-Filled Syringe (PFS)|subcutaneous injection of AMG 334
15972052|NCT03096834|Biological|Placebo Pre-Filled Syringe (PFS)|Subcutaneous injection of placebo
15972053|NCT03096821|Drug|ngFDS selected treatment|Treatment based on next-generation functional drug screening (ngFDS). Treatment with commercially available treatments (per package insert instructions) selected by functional drug screening. For drug screening tumor cells from bone marrow aspirates, peripheral blood, pleural effusion, or excised lymph node samples are purified over Ficoll gradient (bone marrow, peripheral blood, pleural effusion) (GE healthcare) or homogenized and filtered (lymph tissue).
15972055|NCT03096795|Drug|MEDI3506|Healthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single MEDI3506 Dose 1 or Dose 2 or Dose 3 or Dose 4 or Dose 5 or Dose 6 subcutaneously and Dose 6 intravenously in Part 1. Participants with COPD will receive 3 administration of MEDI3506 Dose 4 or Dose 5 or Dose 6 subcutaneously two weeks apart over a 4-week dosing period in Part 2. Healthy Japanese participants will receive a single dose of MEDI3506 Dose 6 intravenously in Part 3.
15972056|NCT03096795|Drug|Placebo|Healthy participants with a history of mild atopy and proven sensitivity to HDM will receive a single dose of placebo matched to MEDI3506 subcutaneously or intravenously in Part 1. Participants with COPD will receive 3 administration of placebo matched to MEDI3506 subcutaneously two weeks apart over a 4-week dosing period in Part 2. Healthy Japanese participants will receive a single dose of placebo matched to MEDI3506 intravenously in Part 3.
15972057|NCT03096782|Biological|Anti-Thymocyte Globulin|Given IV
15972058|NCT03096782|Drug|Busulfan|Given IV
15972059|NCT03096782|Drug|Clofarabine|Given IV
15972060|NCT03096782|Drug|Cyclophosphamide|Given IV
15972061|NCT03096782|Biological|Filgrastim-sndz|Given SC
15972062|NCT03096782|Drug|Fludarabine|Given IV
15972063|NCT03096782|Drug|Melphalan|Given IV
15972064|NCT03096782|Drug|Mycophenolate Mofetil|Given IV or PO
15972065|NCT03096782|Biological|Rituximab|Given IV
15972066|NCT03096782|Drug|Tacrolimus|Given IV
15972067|NCT03096782|Radiation|Total-Body Irradiation|Undergo total body irradiation
15972068|NCT03096782|Procedure|Umbilical Cord Blood Transplantation|Undergo cord blood transplant
15972069|NCT03096769|Other|Ergonomist|The intervention consists of each surgeon meeting with an ergonomist where the ergonomist will adjust the console settings and chair height to an ergonomically optimal position.
15972070|NCT03096756|Drug|GC4702 dry powder|5 mg GC4702 mixed with approximately 270 mg of Prosolv 90 LM - SMCC (siliconized microcrystalline cellulose). Planned dose levels of GC4702 encapsulated dry powder formulation are 50, 100, and 150 mg
15972071|NCT03096756|Drug|GC4702 lipid suspension|112 mg GC4702 mixed with Miglyol 812 plus 0.5% by weight BHA plus 1% by weight of Aerosil 200. Planned dose levels of GC4702 encapsulated lipid suspension formulation are 112, 224, and 336, 448, and 560 mg
15972073|NCT03096756|Other|Placebo Dry Powder|Product matches appearance of the GC4702 dry powder formulation. The Placebo will be 500 mg Miglyol 812 oil containing up to 1% of colloidal silicon dioxide in size 1 capsule.
15972074|NCT03096756|Other|Placebo lipid suspension|Product matches appearance of the GC4702 lipid suspension formulation. The Placebo will be 500 mg Miglyol 812 oil containing up to 1% of colloidal silicon dioxide in size 1 capsule.
15972075|NCT03096756|Other|Fed Condition|with 240 mL (8 fluid ounces) of tap water following a high calorie/high fat meal. Subjects assigned to the fed condition will receive a standard meal per U.S. FDA guidelines7 consisting of high calorie/high fat meal prior to dosing consisting of total calories of 800-1000 of which 150, 250 and 500-600 calories are from protein, carbohydrate and fat, respectively.
15972076|NCT03096756|Other|Fasting Condition|For the fasting condition, GC4702 will be administered following an overnight fast of at least 10 hours, with 240 mL (8 fluid ounces) of water. No food will be allowed for at least 4 hours post-dose. Water will be allowed as desired except for one hour before and after drug administration.
15972077|NCT03096756|Drug|GC4702 lipid suspension - Part 2|Two single doses of GC4702 (dose level to be selected based on Part 1 results), separated by a 7-day washout period
15972078|NCT03096743|Radiation|MR elastography|MR elastography image acquisition will be conducted on the Compact 3T MRI scanner using a modified single-shot spin-echo echo-planar imaging pulse sequence.
15972079|NCT03096743|Radiation|MRI structural brain imaging|MRI structural brain imaging will be done on the Compact 3T MRI at the same time as MR elastography.
15972080|NCT03096743|Procedure|Lumbar puncture|All patients with papilledema will get lumbar punctures with opening pressure as part of their work-up for papilledema. A small number of patients without increased intracranial pressure will receive a lumbar puncture.
15972081|NCT03096743|Other|Optical Coherence Tomography (OCT) imaging|Optical Coherence Tomography (OCT) imaging will measure the peripapillary retinal nerve fiber layer (RNFL) thickness measurements The images with enhanced depth imaging will be obtained to measure the Bruch's membrane orientation.
15972082|NCT03096743|Radiation|Optic nerve B-scan ultrasound|Ultrasound will be used to measure the optic nerve sheath diameter 3 mm posterior to the posterior scleral surface.
15972083|NCT03096730|Drug|Normal saline|Normal saline is intravenously administrated before anesthesia induction
15972084|NCT03096730|Drug|Remifentanil|Remifentanil is intravenously administrated
15972085|NCT03096730|Drug|Sufentanil|Sufentanil is intravenously administrated
15972086|NCT03096730|Drug|Dexmedetomidine injection|Dexmedetomidine is intravenously administrated before anesthesia induction
15972087|NCT03096730|Drug|Nalmefene|Nalmefene is intravenously administrated before anesthesia induction
15972088|NCT03096717|Diagnostic Test|colonoscopy and histology|colonic biopsies for detection of dysplasia
15972089|NCT03096704|Diagnostic Test|vitamine d dosage|dosage of vitamine D in slow transit time constipation
15972090|NCT03096691|Device|cervical pessary|Silicone rings known as arabin pessary are used to support the cervix in women with a sonographic short cervix.
15972091|NCT03096678|Diagnostic Test|Cardiac Magnetic Resonance Imaging|Using a comprehensive MR study (Function, LGE, Tissue Characterization, Strain, T1/T2 mapping) to predict the outcome of LBBB with different cardiac function.
15972092|NCT03096665|Diagnostic Test|blood test|Point of care blood analysis obtained from skin puncture
15972093|NCT03096652|Procedure|Approach for cancer resection|
15972094|NCT03096639|Device|Diaphragmatic Pacing Therapy DPTS|Subjects will undergo DPTS 2 times a day until successfully extubated with no reintubation within 48 hours.
15972095|NCT03096613|Drug|Levothyroxine|Levothyroxine is used to normalize the thyroid hormone level of patients allocated to levothyroxine.
15972096|NCT03096587|Device|XP Endo Finisher|a flexible single use NiTi file with small diameter and no taper, changes from straight M-phase to A-phase in body temperature
15972097|NCT03096587|Device|ultrasonic activated irrigation|by Satelec,Acteon, France
15972098|NCT03096574|Other|Questionnaire|The participants will be approached by a member of the study team and, following recruitment, participants will be asked to fill in a short paper or online questionnaire. Our estimated time for completion is 5-10 minutes, and this time will be stated at the start of the questionnaire. Having completed the questionnaire they will be free to leave without further follow up, and given the contact details of the investigators/research governance office whom they can contact if they have further questions or concerns.
15972099|NCT03096561|Diagnostic Test|blood draw from three different vessels|Patient in cardiac-arrest and cold exposure, diagnostic test: blood draw from three different vessels (central vein, artery, peripheral vein) and measuring of PR
15972100|NCT03096548|Behavioral|Sun Safety Ink! Program|The intervention will be comprised of an online skin cancer prevention training for all tattoo artists of participating studios. The training will include skin cancer rates and risk factors, tattoo rates, recommendations for sun protection practices, a rationale for the relationship of tattoo care and sun safety, and recommended communication strategies for artists to communicate skin cancer prevention to their clients. Additional printed materials (tip-card for clients, posters) to be displayed in tattoo studios, a Sun Safety Ink! website, and social media messages for tattoo studios' Facebook and Pinterest pages will be provided.
15972101|NCT03096548|Behavioral|Attention Control|Studios and artists in this attention control group will not receive the Sun Safety Ink! program. They will continue to provide standard aftercare instructions to clients. The program will be provided to them at the end of the study.
15972102|NCT03096535|Procedure|Cooling|Individualized cooling protocol.
15972103|NCT03096535|Procedure|Thermoneutral|Thermoneutral control day.
15972104|NCT03096522|Drug|Phenytoin 2% spray|Patients will undergo anal fistulotomy then they will use phenytoin 2% spray topically on the anal wound resulting from fistulotomy with each sitz bath (twice per day) untill the anal wound heals completely
15972105|NCT03096522|Procedure|Anal fistulotomy|Probing of the fistula tract followed by lay open of the tract and curettage of granulation tissue in its base
15972106|NCT03096509|Other|MISSION ABC Integrated Care clinic|The Investigators have developed a model of care incorporating key innovations for patients with asthma, COPD and undifferentiated breathlessness. This service is being implemented within Wessex CCGs.
15972107|NCT03096496|Other|QoL questionnaires|Quality of life questionnaires
15972108|NCT03096483|Device|OEC Elite system|Adults undergoing vascular, gastrointestinal (GI), urology or pain management procedures
15972111|NCT03096457|Drug|Pentamidine Isethionate|3 Intralesional injections at days 1,3 and 5
15972112|NCT03096457|Other|Placebo|topical application 2 times a day during 20 days
15972113|NCT03096444|Drug|Ketamine Hydrochloride|2g of topical 10% Ketamine will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.
15972114|NCT03096444|Drug|Amitriptyline Hydrochloride|2g of topical 5% Amitriptyline will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.
15972115|NCT03096444|Drug|Lidocaine Hydrochloride|2g of topical 5% Lidocaine will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.
15972116|NCT03096444|Combination Product|Ketamine hydrochloride, Amitriptyline hydrochloride, and Lidocaine hydrochloride|2g of topical KeAmLi-combo (ketamine 10%, amitriptyline 5%, and lidocaine 5%) will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.
15972117|NCT03096444|Drug|Lipoderm Cream|2g of topical vehicle (Lipoderm) will be applied for 30 minutes on one 4x4cm area on the volar forearm in one of two study visits.
15972118|NCT03096431|Behavioral|Physical Activity|"Self-exercise: number of steps per day, per fitness tracker; self-report of daily activity.
~One-to-one intervention: 30 minute sessions with licensed therapist to include warm-up, generalized strengthening, stretching."
15972119|NCT03096431|Behavioral|Cognitive rehabilitation|One-to-one intervention: 45 minutes sessions with licensed therapist to include graded cognitive tasks designed to improve executive functioning with focus on both restorative and compensatory approaches.
15972120|NCT03096418|Drug|Paclitaxel|Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
15972121|NCT03096405|Diagnostic Test|Polymerase Chain Reaction of Methicillin Resistant Staphyloccus Aureus|Polymerase Chain Reaction of Methicillin Resistant Staphyloccus Aureus
15972122|NCT03096392|Drug|HDV insulin lispro 100 UNT/ML|HDV is the active excipient, added to insulin lispro. HDV binds to a portion of the insulin lispro.
15972123|NCT03096392|Drug|Insulin Lispro 100 UNT/ML|Sterile Water for Injection is added to the insulin lispro, to dilute the insulin lispro equal to the HDV insulin lispro
15972124|NCT03096379|Diagnostic Test|Magnetic resonance imaging|Enterography performed via magnetic resonance imaging
15972125|NCT03096366|Device|Blood flow restriction|With BFR, exercises will be performed at 30% one-rep max with the BFR cuff placed around the proximal thigh and inflated to 80% of limb occlusion pressure (avg: 150 mmHg).
15972126|NCT03096366|Other|Physical therapy|Physical therapy consists of two or three 90-minute sessions per week for 6 weeks and a minimum of 18 visits required for study inclusion.
15972127|NCT03096353|Other|Placebo|saline
15972128|NCT03096353|Drug|Naloxone|We will be using naloxone at normal clinical doses as the study drug. Naloxone is an opiate antagonist and has been used since the 1960 s to reverse the effects of opiate overdoses.
15972129|NCT03096340|Drug|IT-141|Escalating doses administered in mg/m2, IV (in the vein) on days 1 and 15 of each 28 day cycle until progression or unacceptable toxicity develops.
15972130|NCT03096327|Drug|Montelukast|Montelukast sodium is a selective blocker of the CysLT1 receptor. For treatment of chronic asthma, montelukast is administered once daily to adults as a 10-mg film-coated tablet, to children aged 6-14 years as a 5-mg chewable tablet, and to children aged 2-5 years as a 4-mg chewable tablet form.
15972131|NCT03096327|Drug|Placebo|Patients in placebo group will receive identical looking drug (placebo) produced by same manufactured
15972132|NCT03096314|Drug|Vitamin D3|540,000 IU vitamin D3 delivered as a single, liquid enteral dose administered either orally or via naso/orogastric tube
15972133|NCT03096314|Drug|Placebo|A single, liquid enteral dose identical in appearance and consistency to cholecalciferol administered either orally or via naso/orogastric tube.
15972134|NCT03096301|Device|Low-intensity laser|Laser applications will be applied as initial treatment, with 2 sessions per week. A wave length of 780 nm, with an energy density of 25 J/cm2, a power of 50 mW and power density of 1.25 W/cm2, will be used for a duration of 20 seconds per point, resulting in a total energy of 1J per point. The laser will be applied at each point, using a conventional tip in contact with the skin, thus considering an area of 0.04 cm2
15972135|NCT03096301|Device|occlusal plates|"The group undergoing treatment with occlusal plates will be instructed to use the device during sleep, 8 hours per night, for a period of 12 months. The plates will be made following the principles established by Okenson (1998).
~Participants will be molded with alginate to obtain models. In the upper model, a 2 mm acetate plate will be made, to be later replaced with acrylic resin (STRINI et al., 2009), and these plates will be adjusted in centric relation, to promote occlusal stability and disocclusion guide.
~Weekly follow-up and adjustments will be performed during the evaluation period, until the completion of treatment"
15972136|NCT03096301|Device|Placebo|For the placebo group, all the measures described for the group 1 (LIL) will be adopted, however the laser equipment will remain switched off.
15972137|NCT03096288|Drug|Evolocumab|Patients will be randomly assigned to receive a single dose of either evolocumab 420 mg s.c. or placebo (0.9% sodium chloride s.c. injection).
15972138|NCT03096288|Other|Placebo|Patients will be randomly assigned to receive a single dose of either evolocumab 420 mg s.c. or placebo (0.9% sodium chloride s.c. injection).
15972139|NCT03096275|Drug|MMF|Patients were treated with Glucocorticoids combined with methotrexate and mycophenolate mofetil
15972140|NCT03096275|Drug|CYC|Patients were treated with Glucocorticoids and cyclophosphamide sequentially with azathioprine
15972141|NCT03096275|Drug|Glucocorticoids|Patients in the experimental group and comparator group were treated with Glucocorticoids and then gradually tapered
15972142|NCT03096275|Drug|MTX|Patients in the experimental group are treated with Glucocorticoids combined with MTX and MMF
15972143|NCT03096275|Drug|AZA|Patients in the active comparator group were treated with Glucocorticoids combined with CYC followed by AZA
15972144|NCT03096262|Behavioral|Output-Focus Condition|Users are asked to tag more, and force feedback is exerted the more points the user has
15972145|NCT03096262|Behavioral|Input-Focus Condition|Users are asked to tag more and force feedback is exerted based on the number of images the user has analyzed.
15972146|NCT03096249|Drug|Oxytocin|Syntocinon nasal spray: single dose of 24IU (3 puffs of 4IU per nostril)
15972147|NCT03096249|Other|Placebo|Placebo spray: single dose (3 puffs per nostril).
15972148|NCT03096236|Device|EFTR|EFTR with the FTRD developed for gastric resection (gFTRD).
15972149|NCT03096223|Drug|KHK4083|IV administration
15972150|NCT03096210|Other|Titanium-Prepared Platelet Rich Fibrin|Blood samples were collected from the each participant's arm in the test group by 20 ml syringe and then was transferred into 10ml grade IV titanium tube without anticoagulant. After centrifugation of blood samples (2800 rpm, 12 minutes) at room temperature, the T-PRF clot was removed from the tubes with sterile tweezers. 6 blood tubes were collected for a sinus floor elevation/lifting operation and 6 T-PRFs were prepared for each participant.
15972151|NCT03096210|Other|Allograft (CTBA Allograft)|After careful elevation of the schneiderian membrane without perforation, allograft was only used for augmentation of the sinus floor in the control group.
15972152|NCT03096197|Device|Exoskeleton-Assisted Walking|Exoskeleton-Assisted Walking (EAW) is an activity based therapy. Each group will receive 60 minutes of robotic intervention training per session, for a total of 80 sessions.
15972153|NCT03096197|Device|Transcutaneous Lumbosacral Stimulation (TLS)|EAW+TLS. This group will receive 60 minutes of exoskeleton assisted overground walking with simultaneous Transcutaneous Lumbosacral Stimulation (TLS) followed by 15 minutes of overground training without exoskeleton.
15972154|NCT03096184|Drug|Apatinib Mesylate Tablets|500 mg qd.p.o. every day for 21 days as a cycle
15972155|NCT03096184|Drug|Tegafur Gimeracil Oteracil Potassium Capsules|50mg bid p.o. every day for 14 days as a cycle
15972156|NCT03096171|Behavioral|Flourishing App Program|This intervention is based on relaxation, well-being promotion, meditation practices and positive psychology principles. The program is being evaluated in a classroom format into another project and was adapted for this project in the application format for mobile devices. It will last for 16 weeks, with trainings of 20 minutes, four times a week.
15972157|NCT03096158|Other|Ventilatory Muscle Training (TREMVEN)|"Early cardiac rehabilitation after coronary artery bypass graft:
~The enrolled participants will perform IMT or P-IMT for 20 minutes during the period of hospitalization, using the Power Breathe device (POWERbreathe International LTD). During training, subjects will be instructed to maintain diaphragmatic breathing at a rate at 15 to 20 breaths/min. The inspiratory load will be set at 30% of maximal static inspiratory pressure (PImax). It will be occur once per day until the hospital exit."
15972158|NCT03096158|Other|Aerobic Training (AERO)|"Early cardiac rehabilitation after coronary artery bypass graft:
~It will consist of supervised walking, lasting 20 minutes a day, during the period of hospitalization of the participants. Heart rate (HR) will be constantly monitored through a cardiac monitor (Polar), with the objective of maintaining between 50 and 60% of the maximum HR predicted by age; Similar to 40 to 50% of VO2max. Blood pressure, SpO2 and level of dyspnea (Borg's effort perception scale) will also be monitored constantly. It will be occur once per day until the hospital exit."
15972159|NCT03096158|Other|Isometric Handgrip Training (ISO)|"Early cardiac rehabilitation after coronary artery bypass graft:
~Study participants will perform 5 x 2 min alternating bilateral contractions of the hand flexor muscles at 30% maximum voluntary contraction with one minute rest between contractions, in a total of 20 minutes training during the period of hospitalization. It will be occur once per day until the hospital exit."
15972160|NCT03096145|Behavioral|Telephone counseling 1 session|1 call coaching session for nonsmokers that will be piloted and adapted in this study
15972161|NCT03096145|Behavioral|Mobile texting|nonsmokers will receive 3-5 text messages for 4 weeks
15972162|NCT03096145|Behavioral|Health incentive|Smokers receive a $25 gift card if they call the quitline
15972163|NCT03096132|Behavioral|Family Based Behavioral Treatment|Treatment includes 20 90 minute visits over 6 months which include 60 min parent and child separate groups and 30 min behavioral coaching. FBT includes information regarding nutrition and physical activity, as well as behavior therapy skills, including parenting skills, self-monitoring, problem solving skills, motivation systems, emotional regulation, stress management, stimulus control, and relapse prevention.
15972164|NCT03096132|Behavioral|Guided Self-Help Fam. Based Bx Treatment|Treatment includes 14 20 minute visits over 6 months. gshFBT is delivered to parent/child dyads and includes the same content in the FBT groups but it is provided in a manual. The 20-minute visits focus on clarifying information in the manuals, collecting weight and self-monitoring logs, and problem solving any barriers to implementation.
15972165|NCT03096119|Other|home blood pressure measurement|We ask participants to measure their home blood pressure 7 days or more.
15972166|NCT03096093|Biological|ACIT-1|Cell suspension
15972167|NCT03096080|Drug|Tesevatinib|One dose of the study drug in liquid form
15972168|NCT03096067|Other|Heavy slow resistance training|Resistance training for knee extensors. The exercise will be performed at 90% of 1 RM and slowly (6 s/repetition).
15972169|NCT03096067|Other|Moderate slow resistance training|Resistance training for knee extensors. The exercise will be performed at 55% of 1 RM and slowly (6 s/repetition).
15972170|NCT03096054|Drug|LY3143921 hydrate|LY3143921 hydrate will be administered orally on a daily schedule. Each cycle of treatment will consist of 21 days, and patients may initially receive up to 12 cycles. If the patient is benefitting, they may continue beyond 12 cycles.
15972171|NCT03096041|Device|Auriculotherapy for analgesic use|The ASP will be applied to specific pain points
15972172|NCT03096041|Device|Placebo auriculotherapy|The ASP will be applied to placebo points (not specific to pain)
15972173|NCT03096028|Other|maternal vitamin B12 folate level during pregnancy|Maternal Vitamin B12 and folate level at 18&28 weeks of pregnancy is the primary exposure of interest
15972174|NCT03096015|Behavioral|Intensive Comprehensive Aphasia Program|
15972175|NCT03096002|Behavioral|Lifestyle change|The 3-week lifestyle change program will introduce participants to a regular healthy lifestyle including exercise and dietary changes for reducing sugar intake, reducing refined/processed carbohydrate intake, increasing vegetable consumption. The 3-week program will include six supervised exercise sessions and three exercise sessions performed independently (e.g., at home or outside of the lab). The supervised session will include brief behavioral counseling sessions that teach participants self-regulatory skills to promote independence and long-term adherence to exercising and dietary changes.
15972201|NCT03095833|Other|Experimental Task fMRI|For each test the subjects will receive at the same time an image on the screen and a sample of wine (2 ml) delivered in the mouth of the subject thanks to the system of programmable pumps.
15972442|NCT03094325|Device|Pre Operative On-pump intraoperative echocardiography|Center tendency parameters(mean, standard deviation) will be reported for each outcome.
15972176|NCT03095989|Behavioral|Mindfulness|The structure of the protocol incorporates key features of Langer's mindfulness theory. Many of the tasks and exercises have demonstrated increased mindfulness in the general population and have been modified to incorporate ALS-specific exercises that make sense from patients and caregivers' points of view. The intervention provides easily understood multimedia (video and written) presentations of the framework of mindfulness and the aims of the planned tasks. The general structure of the protocol mixes different mindfulness elements; for every week there is a specific topic examined in depth. These topics are: Attention to variability; Positive and negative events; Unpredictability; Sense Making; and Novelty seeking / novelty producing. The overall duration of the protocol is 5 weeks.
15972177|NCT03095976|Procedure|Amnion-Chorion allograft membrane on the root surface of periodontally diseased site.|Application of Amnion-Chorion allograft membrane (ACM) on the root surface of periodontally diseased teeth in conjunction with corticocancellous allograft bone substitute covered by ACM in a combination GTR treatment of periodontal intrabony and furcation defects
15972178|NCT03095963|Other|a mixture of highly charged Lactobacilli and Bifidobacteria (VSL#3®)|Patients assigned to the study group took the probiotic supplement VSL#3® for two months, in addition to levothyroxine
15972179|NCT03095963|Drug|levothyroxin|replacement therapy for hypothyroidism
15972180|NCT03095950|Other|News items with spin|Interpretation of news items with spin
15972181|NCT03095950|Other|News items without spin|Interpretation of news items without spin
15972182|NCT03095924|Other|News items with spin|Interpretation of news items with spin
15972183|NCT03095924|Other|News items without spin|Interpretation of news items without spin
15972184|NCT03095911|Other|News items with spin|Interpretation of news items with spin
15972185|NCT03095911|Other|News items without spin|Interpretation of news items without spin
15972186|NCT03095898|Device|Electroacupuncture|Acupuncture is a form of alternative medicine and is used worldwide for different indications, mainly for pain management. It relies on the stimulation of specific acupuncture points along the skin of the body using thin needles.
15972188|NCT03095872|Device|CO2-laser|Patients with photo-damaged skin are treated with the CO2 laser to remove damaged skin layers.
15972189|NCT03095872|Drug|Vaseline|"After the laser treatment, the wound area will be divided into two parts with a sterile skin marker. One area will be treated with Vaseline, and be marked V. Thus, it is ensured that the care product will be applied correctly to the defined area. Postoperatively, this area of the wound will be treated with Vaseline. In the next seven days the patient will repeat the treatment every day at home."
15972190|NCT03095872|Drug|Bepanthen|"After the laser treatment, the wound area will be divided into two parts with a sterile skin marker. One area will be treated with Bepanthen® Wund- und Heilsalbe, and be marked B. Thus, it is ensured that the care product will be applied correctly to the defined area. Postoperatively, this area of the wound will be treated with Bepanthen® Wund- und Heilsalbe. In the next seven days the patient will repeat the treatment every day at home."
15972191|NCT03095859|Other|Physical rehabilitation.|Early mobility, aerobic exercise, upper and lower limb strength and flexibility training, trunk mobility and core strengthening, inclusive of respiratory therapy and education.
15972192|NCT03095846|Procedure|Cooling|Individualized cooling protocol
15972193|NCT03095833|Other|Odors|"Four odors are available: milk chocolate, dark chocolate, pineapple and apricot.
~In addition, a neutral odor will be used clean air, a control odor transmitted during the task by the olfactometer in the same way as the other 4 odors, the only variant being that no odor will be deposited in the U-tube containing the smells. The images corresponding to the odors will be displayed after the odor has been proposed."
15972194|NCT03095833|Other|Visual stimulation|Concerning behavioral passes, the subjects will be in front of a computer screen on which the task will be presented. For fMRI passes, the visual stimulation of the participant is done by a mirror system placed about 10 cm from the participant's eyes, allowing him to watch a translucent screen on which the visual stimuli are projected. The latter have an intensity similar to that of television images, and therefore below the maximum permitted by labor legislation. The stimuli will be projected via a video projector located at the back of the imager.
15972195|NCT03095833|Other|Experimental Task|"The olfactory sensitivity and the olfactory identification capacities of the subjects will be evaluated using the ETOC test. Subjects will have to define his state of hunger/satiety thanks to a questionnaire of hunger. Finally, subjects should assess the hedonic nature of the odor and the edibility of the odor source. The task to be performed will be the same for the behavioral study as for the imaging study. The subject will receive instruction from the following three: indulge yourself, the subject must think of the desire to eat the food that will be presented to him in olfactory and visual form; Be natural, the subject must act as naturally as possible; Or hold back, the subject must distance themselves from their desire to eat and control themselves. In a second step, an odor will be presented for 5 seconds. This will be based on the subject's inspiration, then an image associated with the odor will be presented for two seconds."
15972196|NCT03095833|Other|Blood tests|Before and after the imaging examination, a blood sample will be taken by a medical imaging manipulator affiliated with the CERMEP whose actions will be remunerated in accordance with the usual hygiene and safety rules. The samples taken will then be annotated with the subject code and kept at the CERMEP. The volume of ghrelin sampling is 5 ml (10 ml for two samples). The volume of the leptin is 5 ml (ie 10 ml for two samples).
15972197|NCT03095833|Other|Questionnaires and test administered|The proposed questionnaires respond to all ethical aspects established by international and national standards to undertake studies on human subjects. Two types of questionnaires will be used in this experiment: Inclusion of the Subjects and Exploratory Tests.
15972198|NCT03095833|Other|fMRI|The purpose of the imaging part is to determine how high-level cognitive control (the setpoint) can affect the price of a food and the olfactory and visual perception of these foods in healthy subjects and Prader-Willi patients.
15972199|NCT03095833|Other|Odors 2|To modify the floral character of the wine used, the investigators will use the β-ionone odorant molecule (4 (2,6,6-trimethyl-1-cyclohexenyl) -3-buten-2-one (CAS number 14901-07-6) Purity ≥97.0% (Fluka) This molecule is commonly found in wines with a violet odor.
15972200|NCT03095833|Other|Images|The visual stimulation of the subject will be done by a system of mirrors placed about 10 cm from the subject's eyes allows him to look at a translucent screen behind the MRI scanner and on which the visual stimuli are projected.
15972202|NCT03095833|Other|Genotyping for susceptibility to β-ionone|Sampling will be done by the subject himself by scratching and firmly pressing into the oral cavity, specifically at the cheeks and tongue for one minute, being careful not to touch the teeth and gums.
15972203|NCT03095833|Other|Experimental Task 2|The investigators will determine how perceptual judgments are modulated by cross-modal stimuli, as well as metacognitive judgments (how individuals judge their own sensory performance). In addition, they will determine how perceptual judgments are modified in the context of group decisions and how language influences performance.
15972204|NCT03095820|Behavioral|Supportive therapy|
15972205|NCT03095820|Behavioral|Multidomain intervention|
15972206|NCT03095807|Drug|NNC9204-1706 A|Administered subcutaneously (s.c., under the skin) Up to 7 dose cohorts will be investigated.
15972207|NCT03095807|Drug|Placebo|Administered subcutaneously (s.c., under the skin)
15972208|NCT03095794|Other|How people learn another's value preference during decision under risk|The aim of this study is to investigate how an agent learns another's value preference when they should make decisions on behalf of another. This experiment consists of 3 parts(i) measuring individual's loss aversion; (ii) feedback based learning of another's value preference; (iii) and decisions on behalf of others.
15972209|NCT03095794|Other|Neural mechanism of making a group decision under risk that influences on in-group members|how individuals evaluate the risk and the outcome when they should make a single agreement decision in a group that will influence every member's payoff regardless of individuals' decisions. For the first part of the experiment, we will measure the individual level of loss aversion which will be used as the parameter for controlling individual differences.
15972210|NCT03095794|Other|Neural mechanism of making a group decision that influences on out-group members|Human is decimated with other species by delegation of one responsibility. Although the person who has no-interests with the outcome of decision, they should make a delegated decision. Therefore, this decision has influences on others who are not part of the group. The third party punishment (Juries decision making) is one example of the decision made by a group influencing the out group members.
15972211|NCT03095794|Other|fMRI|For neuroimaging passes, the expected duration of each of the experimental protocols is about 1h30 for tasks 1 and 2 and about 2h for task 3. The maximum period foreseen for neuroimaging tests is 3 years and will start as soon as possible. Completion of the behavioral tests.
15972212|NCT03095781|Drug|XL888|Given PO
15972213|NCT03095781|Biological|Pembrolizumab|Given IV
15972214|NCT03095768|Other|Lifestyle Education and Cooking Demonstration|Participants will receive an interactive cooking demonstration as well as healthy lifestyle education
15972215|NCT03095755|Other|Ischemic Conditioning|Inflation of blood pressure cuff to 225 mmHg on paretic leg. 1 session: 5 minutes of inflation, 5 minutes deflation, repeated 5 times. Maximum 12 sessions over 4 weeks.
15972216|NCT03095755|Other|Sham|Inflation of blood pressure cuff to 25 mmHg on paretic leg. 1 session: 5 minutes of inflation, 5 minutes deflation, repeated 5 times. Maximum 12 sessions over 4 weeks.
15972217|NCT03095742|Diagnostic Test|Low MAP|Extracerebral MD catheters were positioned in a retrograde direction in the internal jugular vein
15972218|NCT03095742|Diagnostic Test|High MAP|Extracerebral MD catheters were positioned in a retrograde direction in the internal jugular vein
15972219|NCT03095729|Other|Neuropsychological tests|A battery of tests to evaluate the overall cognitive performance of the subjects (memory, executive, attentional or instrumental functions)
15972220|NCT03095716|Other|laparoscopic surgery|Impact of intraperitoneal pressure and warmed, humidified CO2 gas on clinical outcomes after laparoscopic surgery for uterine prolapse in patients aged ˃75 years
15972221|NCT03095703|Drug|Sirolimus|Participants will be given sirolimus tablets. The starting dose is 2 mg once daily which will be given in 1mg tablets. On day 7 the first trough level is measured (using the LC-MS/MS method) and if not within the target range of 5-8ng/ml, dosing adjustments are made. In case of dosing adjustments, the next trough level is measured seven days later and this is repeated weekly until the target range is achieved. In case trough levels are within the target range, the next trough level measurement is at month 3, after which dosing adjustments are made if necessary, and at month 6. The maximum daily dose is 40mg. No placebo is given.
15972222|NCT03095690|Other|High resolution peripheral scanner (HRpQCT).|radius and tibia osteodensitometry measurement
15972223|NCT03095677|Other|Program of training with exercises including apnea|16 training session on cycle ergometry with exercises including apneas.
15972224|NCT03095677|Other|Program of training with exercises without apnea|16 training session on cycle ergometry with exercises without apnea
15972225|NCT03095664|Behavioral|Intervention group|A behavior change program with 4 monthly 90-min sessions about healthy eating and physical activity.
15972226|NCT03095651|Biological|MK-5160 16 nmol/kg|MK-5160 16 nmol/kg, subcutaneous injection administered daily for 12 days
15972227|NCT03095651|Biological|MK-5160 32 nmol/kg|MK-5160 32 nmol/kg, subcutaneous injection administered daily for 12 days
15972228|NCT03095651|Biological|MK-5160 64 nmol/kg|MK-5160 64 nmol/kg, subcutaneous injection administered daily for 12 days
15972229|NCT03095651|Biological|Glargine 0.4 U/kg|Glargine 0.4 U/kg, subcutaneous injection administered daily for 12 days
15972230|NCT03095651|Biological|Placebo to Glargine|Placebo to glargine, subcutaneous injection administered daily for 12 days
15972231|NCT03095651|Biological|Placebo to MK-5160|Placebo to MK-5160, subcutaneous injection administered daily for 12 days
15972232|NCT03095651|Drug|Dextrose|20% solution of dextrose; adjusted to maintain the various glycemic levels at 100 mg/dL given as a continuous intravenous infusion for 6-30 hours.
15972233|NCT03095651|Biological|Glargine 0.6 U/kg|Glargine 0.6 U/kg, subcutaneous injection administered daily for 12 days
15972234|NCT03095638|Drug|Conventional dolutegravir 10 mg tablet|Single dose of five 10 mg DTG tablets will be administered directly to mouth with 240 mL of water in the morning to randomized subjects in fasting state present in Part 1. DTG will be a white, round shaped, biconvex tablet.
15972235|NCT03095638|Drug|Conventional dolutegravir 50 mg tablet|Single dose of one 50 mg tablet will be administered directly to mouth with 240 mL of water in the morning to randomized subjects in fasting state present in Part 1. DTG will be a white, round shaped, biconvex tablet.
15972310|NCT03095196|Drug|HF drugs|full medical therapy to treat HF symptoms and its progression.
15972311|NCT03095183|Device|Grape flavored Puritan Junior tongue depressor|
15972236|NCT03095638|Drug|Dispersible dolutegravir 5 mg tablet|Single dose of five 5 mg DTG tablets will be administered as dispersed in water or direct to mouth with 240 mL of water in the morning to randomized subjects in fasting state present in Part 2. DTG will be a white, round shaped, biconvex tablet.
15972237|NCT03095638|Drug|Conventional dolutegravir 25 mg tablet|Single dose of one 25 mg DTG tablet will be administered directly to mouth with 240 mL of water in the morning to randomized subjects in fasting state present in Part 2. DTG will be a white, round shaped, biconvex tablet.
15972238|NCT03095612|Drug|Selinexor|Oral XPO1 inhibitor selinexor (KPT-330) in combination with Docetaxel
15972239|NCT03095599|Biological|IVACFLU-S|"IVACFLU-S is seasonal inactivated, split virion, trivalent influenza vaccine (A/H3N2, A/H1N1, and B), produced in GCP facility by IVAC uses embryonated chicken eggs. This vaccine is purified by sucrose gradient ultracentrifugation (Alfa Wassermann, West Caldwell, NJ), and inactivated with formaldehyde. Each 0.5 mL dose of vaccine contains
~NYMC X-179A (A/California/7/2009) (H1N1) - 15μg hemagglutinin (HA)
~NYMC X-263B (A/HongKong/4801/2014) (H3N2) - 15μg HA
~NYMC BX-35 (B/Brisbane/60/2008) (B) - 15μg HA"
15972240|NCT03095599|Other|Placebo|Phosphate buffered saline with pH 7.2; 0.5 ml/per dose
15972241|NCT03095586|Other|News items with spin|Interpretation of news items with spin
15972242|NCT03095586|Other|News items without spin|Interpretation of news items without spin
15972243|NCT03095573|Device|Lateral-viewing CapsoCam device|Small bowel capsule endoscopy examination with the Lateral-viewing CapsoCam device
15972244|NCT03095573|Device|Axial-viewing capsule|Small bowel capsule endoscopy examination with the Axial-viewing capsule device
15972245|NCT03095560|Device|NIRVANA|Nirvana is the first device based on optoelectronic infrared sensors, though which the patient can simply interact through his movements. The rehabilitation exercises with audio-visual stimuli and feedback involve the perceptual-cognitive skills of patients, resulting in a motivational training. Several modes and increasing levels of difficulty characterize each exercise, so the therapist can use a pre-defined rehabilitative solution or new ones, according to patient's needs. The results achieved during rehabilitation allow the therapist to evaluate the patient's actual progress, and then to modify the rehabilitation program. The system is connected to a projector or a big screen (put in front of the patient), reproducing an interactive series of exercises (for trunk, upper and lower limbs, and cognition), thanks to an infrared video camera analyzing the patient's movements, it creates interactivity.
15972246|NCT03095547|Drug|cyclosporine A|Pharmacokinetic assessment Area Under the plasma concentration: time Curve (AUC) 0-t
15972247|NCT03095547|Drug|Posaconazole|Pharmacokinetic assessment AUC 0-tau
15972248|NCT03095547|Drug|Pantoprazole|Pharmacokinetic assessment AUC 0-tau
15972249|NCT03095547|Drug|F901318|Pharmacokinetic assessment AUC 0-tau
15972250|NCT03095547|Drug|Tacrolimus|Pharmacokinetic assessment AUC 0-t
15972251|NCT03095534|Behavioral|3-Step Workout for Life|a 10-week moderate exercise program
15972252|NCT03095521|Drug|Angal, lozenges [menthol],|Angal, administered per 1 lozenge, with an interval 2 hours or more, 6-10 lozenges per day, for a maximum 4 days or until full illness resolution.
15972253|NCT03095521|Drug|ANTI-ANGIN® FORMULA|"0,2 mg + 2 mg + 50 mg (LLC Valeant, Russia). Administered per 1 lozenge, with an interval 2 hours or more, up to 6 lozenges per day, for a maximum 5 days or until full illness resolution."
15972254|NCT03095508|Drug|Angal S, topical spray [Menthol]|0,5 mg + 2 mg (Sandoz d.d., Slovenia), administered as three to five consecutive presses on the actuator button, 6-10 times per day, for a maximum 4 days or until full illness resolution
15972255|NCT03095508|Drug|ANTI-ANGIN® FORMULA, topical metered spray|"0,12 mg + 0,24 mg (LLC Valeant, Russia) administered as one to two consecutive presses on the actuator button, up to 6 times per day, , for a maximum 5 days or until full illness resolution"
15972256|NCT03095495|Device|Heated Humidified High Flow Nasal Cannula|HHHFNC therapy is a simple to use system that delivers warm and moist air/oxygen mixture at high flow rates that generate positive airway pressure
15972257|NCT03095495|Device|Standard Therapy (Low Flow Nasal Cannula)|will be used only if the patient needs oxygenation and Rescue HHHFNC will be used if the patient needs PICU
15972258|NCT03095482|Device|Transcranial Direct Current Stimulation (tDCS)|Participants will receive 20 minutes of either active or sham tDCS prior to in vivo exposure to feared targets.
15972259|NCT03095482|Behavioral|In vivo exposure therapy|Participants will receive 30 minutes of in vivo exposure to feared targets following either active or sham tDCS
15972260|NCT03095469|Drug|Dexmedetomidine|when the operation begin,dexmedetomidine will be pumped at 0.4μg/kg•h for 15 minutes ,then reduce the dose to 0.2μg/kg•h until 24h after PCI.
15972261|NCT03095469|Drug|0.9%NaCl solution|when the operation begin,0.9%NaCl solution will be pumped at 0.1ml/kg•h until 24h after PCI.
15972262|NCT03095456|Drug|Revefenacin|Revefenacin administered via nebulization.
15972263|NCT03095456|Combination Product|Spiriva Handihaler®|Spiriva Handihaler® contains Spiriva (also known as Tiotropium) and is administered via HandiHaler® device.
15972264|NCT03095456|Drug|Placebo for Revefenacin|Placebo administered as double blind, double dummy via nebulization.
15972265|NCT03095456|Drug|Placebo for Spiriva Handihaler®|Placebo administered as double blind, double dummy via Spiriva HandiHaler®.
15972266|NCT03095443|Other|Music Therapy - Personalized Playlist|Participant receives personalized playlist.
15972267|NCT03095443|Other|Music Therapy - Standard Playlist|Participant receives a standard low beats per minute playlist.
15972268|NCT03095443|Other|Attention Control|Participant receives an audio-book.
15972269|NCT03095430|Device|Monitoring|Monitoring
15972270|NCT03095417|Behavioral|Physical Exercise Intervention|In home exercise intervention.
15972271|NCT03095417|Behavioral|Cognitive Training Intervention|Online cognitive training modules.
15972272|NCT03095417|Behavioral|Stretching Control|In home stretching.
15972273|NCT03095417|Behavioral|Cognitive Control|Online control puzzles and games.
15972274|NCT03095404|Drug|Low Dose Lidocaine|60 cc syringe with 2 vials of 1% lidocaine (40cc's) low dose solution using adjusted body weight formula
15972275|NCT03095404|Drug|High Dose Lidocaine|60 cc syringe with 2 vials of 2% lidocaine (40 cc's) high dose solution using adjusted body weight formula
15972312|NCT03095183|Device|Traditional unflavored Puritan Regular Tongue Depressor|
15972481|NCT03094065|Other|News items with spin|Interpretation of news items with spin
15972276|NCT03095391|Device|VFI|The IV administered visible fluorescent injectate (VFI)™ agent is comprised of a mixture of 2 different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.
15972277|NCT03095391|Device|Iohexol|Iohexol is a contrast enhancement agent which, following intravascular injection, is distributed in the extracellular fluid compartment and is excreted unchanged by glomerular filtration.
15972278|NCT03095378|Procedure|Control|Periodontal plastic surgery aiming root coverage by palatal connective tissue graft. Root treatment with scaling and root planing
15972279|NCT03095378|Procedure|citric acid plus tetracycline|Periodontal plastic surgery aiming root coverage by palatal connective tissue graft. Root treatment with citric acid plus tetracycline
15972280|NCT03095378|Procedure|antimicrobial photodynamic therapy|Periodontal plastic surgery aiming root coverage by palatal connective tissue graft. Root treatment with antimicrobial photodynamic therapy
15972281|NCT03095365|Other|Dry needling|Insertion of solid filament needles in the muscle
15972282|NCT03095365|Other|Pain neuroscience education|Explanation of the functioning of the central nervous system, the differences between acute pain and chronic pain and the importance of thoughts and beliefs in the processing and chronification of pain
15972283|NCT03095365|Other|Conventional treatment|Electrotherapy: Transcutaneous electrical nerve stimulation and microwaves
15972284|NCT03095352|Biological|Pembrolizumab|200 mg Given IV
15972285|NCT03095352|Drug|Carboplatin|Arm A: AUC 5 IV every 3 weeks Arm B: AUC 5 IV every 3 weeks
15972286|NCT03095352|Biological|Trastuzumab|For HER2+ patients: IV every 3 weeks using standard approved dosing
15972287|NCT03095339|Other|Educational package|The educational package was offered to 30 villages post randomization. The field team completed the SARAR PHAST with community members for 2-3 days in each intervention village. The movie was projected every night for 2-3 days in each intervention village.
15972288|NCT03095326|Dietary Supplement|Zinc|formula of ZnSO4, usually used to treat zinc deficiency.
15972289|NCT03095326|Drug|Sucrose|Placebo of sucrose syrup
15972290|NCT03095326|Biological|PCV Vaccine|Pneumococcal conjugate vaccine
15972291|NCT03095326|Biological|PPV Vaccine|Pneumococcal polysaccharide vaccine
15972292|NCT03095313|Other|18F-NaF|"At baseline a target dose of 125 MBq 18F-NaF will be administered intravenously to all subjects who will then undergo dual cardiac and respiratory-gated PET-CT imaging of the heart and aortic valve. 125ml of iodine-based contrast agent (iohexol [Omnipaque™]) will be given for the CT. Nitroglycerin will be given to increase the size of the coronary arteries and a possible dose of metoprolol may be given to control target heart rate.
~Repeat contrast-enhanced CT of the heart and aortic valve will be conducted at Year 2 to investigate to investigate whether 18F-NaF activity predicts progression of calcification in prosthetic valves."
15972293|NCT03095300|Procedure|Prone position|Patients are rotated from the supine to the prone position for a period of 2 hours.
15972294|NCT03095287|Biological|Alphanate|Daily intravenous infusion of Alphanate 100 IU/kg/day
15972295|NCT03095274|Drug|Durvalumab|Durvalumab, 1500 mg Q4W for 12 months.
15972296|NCT03095274|Drug|Tremelimumab|Tremelimumab 75 mg Q4W for up to 4 doses/cycles.
15972297|NCT03095261|Behavioral|Web-based exercise diary|All participants will have access to a web-based exercise tracking tool called ExTracker. Individuals will be asked to submit their exercise diaries daily for 52 weeks, using the ExTracker program. Upon entering exercise information, participants will receive individual (e.g., You've completed 50% of your exercise sessions this week!) and group-level (e.g., You and the other people in this study are walking across Canada! Next stop - Toronto!) feedback. Should participants cease to use the platform for one week, they will receive an email reminder to re-engage with the platform. Three such emails will be sent to lapsing participants.
15972298|NCT03095261|Device|Accelerometer|All participants will be asked to wear the StepsCount Piezo accelerometer, and track the steps per day and bout minutes of MVPA per day measured by the device. Additionally, participants will be mailed an accelerometer (and asked to return their used ones) at study weeks 26 and 52 in order for the researcher to confirm the data inputted into the ExTracker from the device.
15972299|NCT03095261|Behavioral|Virtual Reward|"Participants will earn 'virtual rewards' (i.e. a heart badge) each day they track their exercise, for the first six months of the study. In the second six months, participants will crossover to the other therapy, the 'financial incentive' therapy, for six months."
15972300|NCT03095261|Behavioral|Financial Incentive|"Participants will earn financial incentives each day they track their exercise, for the first six months of the study. In the second six months, participants will crossover to the other therapy, the 'virtual rewards' therapy, for six months."
15972301|NCT03095248|Drug|Selumetinib|Continuous twice daily dosing; oral agent
15972302|NCT03095235|Dietary Supplement|Dietary riboflavin|Dietary riboflavin is vitamin B2. It has been shown to be safe in children in the treatment of migraines at doses of 400 mg per day. There are no known documented side effects
15972303|NCT03095222|Drug|Ketamine|To be given as intravenous infusion. Ketamine infusions will be started at 5 mg/hr and can be increased by nursing staff based on patient-reported pain relief up to a maximum hourly rate of 20 mg/hr.
15972304|NCT03095222|Drug|Opioids|Standard of care for pain management.
15972305|NCT03095209|Drug|Carboplatin|chemo regimen will carboplatin-paclitaxel managed by the treating medical oncologist. Patients are planned to receive surgery at approximately 6 to 9 weeks (maximum 12 weeks post-CRT) after finishing CRT with surgical aspects determined by the treating surgical oncologist.
15972306|NCT03095209|Drug|Paclitaxel|chemo regimen will carboplatin-paclitaxel managed by the treating medical oncologist. Patients are planned to receive surgery at approximately 6 to 9 weeks (maximum 12 weeks post-CRT) after finishing CRT with surgical aspects determined by the treating surgical oncologist.
15972307|NCT03095209|Radiation|Radiation Therapy|The total radiation dose will be 50.4 Gy in daily fraction of 1.8 Gy for esophageal cancer and 60 Gy in daily fraction of 2 Gy for non-small cell lung cancer.
15972308|NCT03095196|Device|Multipolar CRT-d, plus conventional drug therapy for HF.|A random CRT-d implant performed via multipolar left ventricle lead, in failing heart patients treated by maximal drug therapy.
15972309|NCT03095196|Device|Bipolar CRT-d, plus conventional drug therapy for HF.|A random CRT-d implant performed via bipolar left ventricle lead (group B), in failing heart patients treated by maximal drug therapy.
15972313|NCT03095170|Behavioral|Computerized brain fitness training|Will use the commercially available Posit Science product BrainHQ™ (www.brainhq.com) on tablets (e.g. iPads). Participants will complete 45-60 minutes of training daily in the program.
15972314|NCT03095170|Behavioral|Yoga|Will use adapted Hatha Yoga where participants sit on armless chairs placed on sticky mats for some asana (poses) and use the chair for support throughout. This adapted Hatha Yoga style is appropriate for older adults including those who have limited mobility, use walkers or are in wheelchairs. The appropriately sequenced yoga practice meets the American College of Sports Medicine recommendation for older adults for muscle strengthening and flexibility. Instructions are modeled for the participants
15972315|NCT03095170|Behavioral|Wellness Education|The education component will involve daily 60-minute group sessions with topics such as Introduction to the Program, Living with MCI, Changes in Roles, Communication and Relationships, Sleep Hygiene, Steps to Healthy Brain Aging, Preventing Dementia, MCI and Depression, Nutrition, Safety and Assistive Technologies, and Participating in Research, Community Resources, Meaning and Purpose, and Joy.
15972316|NCT03095170|Behavioral|Support Group (patient and partner)|Journal© as a basis for reminiscence-focused group sessions. Partner: The care partner support group meets separately from the patient group for 45-60 minutes daily.
15972317|NCT03095170|Behavioral|Cognitive Rehabilitation|"Will provide each couple with memory compensation training 5 days per week for 2 weeks, with initial and ending adherence sessions. All sessions will involve 45- 60 minutes of training. The curriculum is described briefly here.
~Learning phases. three training stages from learning theory: 1) an acquisition phase in which use of the memory compensation system is learned, 2) an application phase in which a participant is taught to apply to his/her daily life, and 3) an adaptation phase in which a participant practices incorporating into his/her daily life so as to make its use habitual."
15972318|NCT03095157|Dietary Supplement|fractionated marine lipid concentrate derived from anchovy and sardine oil|Patients will be randomized to receive perioperative treatment versus placebo
15972319|NCT03095144|Device|Spinal anesthesia|Pyloromyotomy under spinal anesthesia
15972320|NCT03095144|Device|General anesthesia|Pyloromyotomy under general anesthesia
15972321|NCT03095131|Device|Heart Spectrum Blood Pressure Monitor|The Heart Spectrum Blood Pressure Monitor provides a convenient and effective filtering application compared with traditional methods that require a visit to a physician for a 12-lead ECG.
15972322|NCT03095118|Drug|Daratumumab|Intravenously (IV) at a dose of 16 mg/kg once weekly for 8 weeks, followed by once every 2 weeks for eight additional doses
15972323|NCT03095105|Drug|200 mg BIA 6-512|capsules containing BIA 6-512 200 mg was administered orally, with 240 mL of mineral water without gas at room tempera¬ture
15972324|NCT03095092|Drug|BIA 6-512 400 mg|4 capsules of BIA 6-512 100 mg / oral administration with 240 mL of potable water .Subjects were administered a 400 mg BIA 6-512 single-dose on two different occasions. In one treatment period subjects were dosed with a single oral dose of 400 mg after a fasting of at least 8 hours, and in the other treatment period subjects were dosed with a single oral dose of 400 mg after a standard meal. Subjects were requested to fast overnight for at least 8 hours before product administration.
15972325|NCT03095079|Drug|recombinant human endostatin|"Cisplatin:dose was based on patient's weight and could be adjusted for weight change,75 mg/m^2 by IV infusion separated in 3 different days Dacarbazine:250mg/m2,administered by intravenous (IV) infusion on the 1 to 5 day of each cycle
~Hr-endostatin:dose based on body surface area as 15mg/m2,continuous intravenous infusion from day 1 to day 14"
15972326|NCT03095066|Drug|AVP-786|oral capsules
15972327|NCT03095066|Drug|Placebo|oral capsules
15972328|NCT03095053|Procedure|comprehensive chromosome screening|"Biopsy Blastocysts with morphological grades of ≥2BB will be biopsied on day 5 of in vitro embryo culture. Biopsies will be performed using a Hamilton Thorne Zilos laser (Hamilton Thorne, MA, USA), with 3-10 trophectoderm cells removed from the blastocysts.
~Comprehensive chromosome screening All trophectoderm biopsies will be processed for analysis by Next-Generation Sequencing (NGS, Illumina, California, USA)."
15972329|NCT03095040|Drug|CM082 combined with everolimus|CM082 tablets (200 mg, 2 tablets) taken orally once a day on 28-day cycles, everolimus tablets (10 mg, 2 tablets) taken orally once a day on 28-day cycles
15972330|NCT03095040|Drug|CM082|CM082 tablets (200 mg, 2 tablets) taken orally once a day on 28-day cycles, dummy tablets for everolimus (2 tablets) taken orally once a day on 28-day cycles
15972331|NCT03095040|Drug|Everolimus|Everolimus tablets (10 mg, 2 tablets) taken orally once a day on 28-day cycles, dummy tablets for CM082 (2 tablets) taken orally once a day on 28-day cycles
15972332|NCT03095027|Device|FID122819 contact lenses|Investigational spherical silicone hydrogel contact lenses for daily disposable wear
15972333|NCT03095027|Device|Stenfilcon A contact lenses|Commercially available spherical silicone hydrogel contact lenses for daily disposable wear
15972334|NCT03095014|Procedure|Cesarean Myomectomy|Myomectomy was done during Cesarean section
15972335|NCT03095014|Procedure|Cesarean section|Cesarean delivery
15972336|NCT03095001|Drug|Bevacizumab|Bevacizumab 5mg/kg intraperitoneal administration every 3 weeks for 4-6 cycles
15972337|NCT03095001|Drug|Carboplatin|carboplatin AUC=5 intraperitoneal administration every 3 weeks 4-6 cycles
15972338|NCT03095001|Drug|paclitaxel|paclitaxel 175mg/m2, iv d1, every 3 weeks for 4-6 cycles
15972339|NCT03094988|Behavioral|Cognitive and physical prehabilitation|Participants engage in cognitive and physical training daily for approximately 2-4 weeks prior to surgery.
15972340|NCT03094988|Other|Active attention control|Participants will be provided with personal health educational materials and access to the control version of cognitive training program.
15972341|NCT03094962|Other|Motion capture|Capture kinematics of finger movements
15972342|NCT03094962|Diagnostic Test|MR scan|Capture MR images of hand and fingers in three postures
15972343|NCT03094962|Diagnostic Test|CT scan|Capture CT images of hand and fingers in three postures
15972364|NCT03094845|Biological|Placebo solution|15 injections over 7 weeks
15972365|NCT03094845|Biological|hdmASIT+TM|15 injections over 7 weeks
15972366|NCT03094832|Drug|Miransertib|Miransertib capsules administered orally either 1 hour before or 2 hours after a meal
15972367|NCT03094819|Behavioral|Financial Incentive|Participants will receive usual care and a $25 payment if they obtain a confirmed eye examination.
15972482|NCT03094065|Other|News items without spin|Interpretation of news items without spin
15972344|NCT03094949|Procedure|Partial Nephrectomy|The renal capsule is cut in a monopolar fashion around the tumor. After the renal artery is clamped with a bulldog clamp, cold cutting by scissors into the renal parenchymal boundary of the tumor is performed with an optimal surgical margin (a few millimeters). After retrograde injection of diluted indigo carmine, continuous suturing of the opened collecting system and transection of the major vessels is performed with intracorporeal knot-tying. Parenchymal suturing is performed in a continuous fashion. The 20-30 cm length of thread is used, and a knot is made at the end of the thread. A large Hem-o-lok polymer clip (Weck Closure System, Research Triangle Park, NC) is attached on the proximal side of the knot. Before the thread is tightened or cinched, the parenchyma is sutured in a running fashion with three or four stitches without any bolster so that the renal bed is kept in its natural position during the suturing.
15972345|NCT03094949|Procedure|microwave ablation|Microwave ablation is a technique that uses thermal therapy to induce complete necrosis of tumor in situ by using microwave ablation device.Antenna in the microwave ablation device was percutaneously inserted into the tumor and placed at designated place under US guidance. For tumors less than 1.5 cm, one antenna was inserted and for tumors measuring 1.5 cm or greater, two antennae were inserted in parallel with an inter-antenna distance of 1.0-2.5 cm, which were used simultaneously during MWA to obtain larger ablation zone. A 20G thermocouple was inserted about 0.5-1 cm away from the tumor for real-time temperature monitoring during MWA. MW emission didn't stop until the heat-generated hyperechoic water vapor completely encompassed the entire tumor and the measured temperature reached 60°C or remained above 54°C for at least three minutes.
15972346|NCT03094936|Procedure|APC|Ablation of the dilated gastro-jejunal anastomosis with Argon Plasma Coagulation. This procedure induces cicatrization process around the stoma and propitiates its reduction.
15972347|NCT03094936|Device|Endoscopic Suture Technique (OverStitch TM)|OverStitchTM Endoscopic Suturing System. Stitches will be placed per-orally with the aforementioned device around the dilated stoma in order to reduce the diameter of the anastomosis. In this group, ablation with APC will be done immediately before suturing.
15972348|NCT03094923|Other|Inspiratory Muscle Training|"The inspiratory muscle training (IMT) will be carried out in the IG with Threshold® IMT (Respironics New Jersey, Inc) consisting of a unidirectional flow control valve which assures the constant resistance (linear load) between 7 and 41cmH20.
~The IMT will be carried out in the sitting position with a load of 30% of the MIP during the two weeks preceding the surgery, seven days a week, twice daily in three series of ten repetitions with a 30 second interval between series, under the supervision of a physiotherapist. A load of 15% of the MIP was used only on the first day of training in order for the individual to adapt to the equipment. Subsequently, the 30% MIP load will be applied and readjusted according to the new MIP values determined every four days."
15972349|NCT03094910|Diagnostic Test|Examination of vibration perception threshold in fingertips|Vibration perception threshold is examined for 7 different frequences. All fingers are examined except for the thumbs.
15972350|NCT03094910|Diagnostic Test|Ewing's tests|A battery of tests invented to diagnose the cardiac autonomic neuropathy in diabetics. Heart rate and blood pressure are measured during Valsalva maneuver, deep breathing, active standing and prolonged handgrip.
15972351|NCT03094910|Diagnostic Test|Tilt table test|Blood pressure and heart rate are measured continuously while the participant is brought to a 60 degree position and held there for 15 minutes.
15972352|NCT03094910|Diagnostic Test|Thermography|An infrared thermographic camera is applied to record temperature of the fingers of the participant before and after cooling in 10 degree water for 1 min.
15972353|NCT03094910|Diagnostic Test|123I-MIBG|123I-MIBG is injected into a vein, and an early and a late scan is performed. Regions Of Interest are selected for the heart and mediastinum, and the ratio as well as well as the Washout Rate can be determined. MIBG is a noradrenaline analogue and the examination is performed to visualize a potential imbalance of the autonomic nervous system of the heart.
15972354|NCT03094910|Diagnostic Test|Blood samples|"The blood samples will be assayed for hemoglobin, long-term blood sugar, C-reactive protein, sodium, potassium, magnesium, albumin, TSH, vitamin B and D, and ionized calcium.
~Patients with suspected Raynaud's disease will be tested for anti-nuclear antibodies (ANA) to screen for underlying rheumatic illness.
~Blood samples will also be drawn during tilt table testing and assayed for plasma catecholamines."
15972355|NCT03094897|Drug|18F-Al-NOTA-MATBBN PET/CT|18F-Al-NOTA-MATBBN(PET imaging agent) given by vein before PET scans.Perform PET/CT for each enrolled volunteer or patient at 60-90min.
15972356|NCT03094897|Device|PET/CT|Imaging with 18F-Al-NOTA-MATBBN PET/CT.
15972357|NCT03094884|Radiation|Pulsed Low Dose Radiation|Treatment naïve patients with non-small cell lung cancer or esophageal cancer whose planned treatment regimen is concurrent CRT followed by surgery. The total radiation dose will be 50.4 Gy in daily fraction of 1.8 Gy for esophageal cancer and 60 Gy in daily fraction of 2 Gy for non-small cell lung cancer. The concurrent chemo regimen will carboplatin-paclitaxel managed by the treating medical oncologist. Patients are planned to receive surgery at approximately 6 to 9 weeks after finishing CRT with surgical aspects determined by the treating surgical oncologist.
15972358|NCT03094884|Drug|Carboplatin|Treatment naïve patients with non-small cell lung cancer or esophageal cancer whose planned treatment regimen is concurrent CRT followed by surgery. The total radiation dose will be 50.4 Gy in daily fraction of 1.8 Gy for esophageal cancer and 60 Gy in daily fraction of 2 Gy for non-small cell lung cancer. The concurrent chemo regimen will carboplatin-paclitaxel managed by the treating medical oncologist. Patients are planned to receive surgery at approximately 6 to 9 weeks after finishing CRT with surgical aspects determined by the treating surgical oncologist.
15972359|NCT03094884|Drug|Paclitaxel|Treatment naïve patients with non-small cell lung cancer or esophageal cancer whose planned treatment regimen is concurrent CRT followed by surgery. The total radiation dose will be 50.4 Gy in daily fraction of 1.8 Gy for esophageal cancer and 60 Gy in daily fraction of 2 Gy for non-small cell lung cancer. The concurrent chemo regimen will carboplatin-paclitaxel managed by the treating medical oncologist. Patients are planned to receive surgery at approximately 6 to 9 weeks after finishing CRT with surgical aspects determined by the treating surgical oncologist.
15972360|NCT03094871|Behavioral|FACE-PC|
15972361|NCT03094858|Device|Smartphone with prompts|Smartphone will be used to prompt randomly selected participants in intervention group to be active
15972362|NCT03094858|Device|Wristband|Wristband will monitor activity of all participants
15972363|NCT03094858|Device|Smartphone|Smartphone will be used to monitor activity but prompts will not be given to randomly selected participants
15972368|NCT03094819|Behavioral|Retinal Care DR|Participants will receive: (1) point of care risk assessment for vision- threatening diabetic retinopathy, (2) retinal specialist interpretation of their risk assessment data, and (3) care coordination designed to improve the eye examination rate for patients with diabetes at increased risk for vision- threatening diabetic retinopathy.
15972369|NCT03094806|Device|Acapella Vibratory PEP Therapy Device plus usual care|The acapella® Vibratory PEP Therapy System (PEP-FV) device is a handheld device that operates in same principle as standard FV. Unlike standard FV, it is not gravity dependent. It comes in two different devices to accommodate for different flows rates of the patient. It has similar properties of a standard FV and may be better tolerated.
15972370|NCT03094806|Device|Sham Acapella Vibratory PEP Device plus usual care|The Sham Acapella Vibratory PEP Device is the same as the Therapy Device, except the flutter valve has been removed from the device.
15972371|NCT03094793|Other|abnormal EEGs|"This study consists in a scalp EEG to detect, in real time, based on measurements of reaction time and accuracy of responses (recorded every two seconds), the level of attention given by the participant in a repetitive task of constant difficulty and correlate the behavioral results to AIC identified on the EEG recording. A computer equipped for the realization of the STABILO test is already available, its connection / synchronization with standard acquisition systems EEG data is already effective through an RS232 serial port.
~Included patients will see their EEG extended for fifteen minutes, during which they will carry out a computerized attentional task to evaluate the stability of the attention."
15972372|NCT03094780|Behavioral|Quality of life counseling|Will receive quality of life counseling from PI, social workers, and physical therapists
15972373|NCT03094780|Other|Video-conference quality of life counseling|Participants may video-conference to other sites to participate in group session dependent on Florida, Northfield and Arizona enrollment
15972374|NCT03094767|Other|Cardiovascular Rehabilitation|Aerobic and anaerobic exercises performed for 12 weeks, 3x/week, of 60 minutes each.
15972375|NCT03094767|Other|Initial and Final assessment|Measuring blood preassure, heart rate, Borg scale, respiratory rate, oxygen saturation and HbA1C in the first day of assessment and after 12 weeks.
15972376|NCT03094754|Procedure|nevi excision|After general anesthesia, nevi excision in children is performed.
15972377|NCT03094741|Other|CancerLife|CancerLife is a mobile digital solution that allows patients to broadcast their health status inside a private invitation only group, text, email or publicly in Facebook or Instagram. By doing, so the patient collects his/her own patient-reported outcomes data and then share this data with their doctor or care team.
15972378|NCT03094728|Diagnostic Test|HLA cross matching|"HLA Typing and Mismatch
~Cross matching (total and autocross):
~Cross match involves placing recipient serum onto donor lymphocytes and a cytotoxic reaction (deemed 'positive') suggests the presence of preformed donor specific antibodies (DSAs),Second, the original crossmatch should be repeated with the addition of the agent Dithiothreitol (DTT). DTT reduces the disulfide bonds in IgM thereby preventing IgM antibodies from generating a positive result."
15972379|NCT03094715|Device|Thrombectomy|Mechanical thrombectomy with state of the art thrombectomy devices (i.e. stent-retrievers, aspiration catheters). Devices will be used per instructions for use (IFU).
15972380|NCT03094715|Other|Best medical care|Best medical treatment will be performed as detailed in established Standard Operating Procedures, following regional guidelines (American Heart Association (AHA), European Stroke Organisation (ESO), Deutsche Schlaganfall-Gesellschaft (DSG), local country, etc.). If applicable, the reason for iv tissue plasminogen activator (tPA) ineligibility has to be documented on the eCRF.
15972381|NCT03094689|Other|Cold water immersion|
15972382|NCT03094689|Other|Water immersion|
15972383|NCT03094676|Other|Massage|Approximately 12 minutes of massage will be performed in full. The massage will be performed on the lower (anterior) and trunk (posterior)
15972384|NCT03094676|Other|Exercise|A wingate protocol will be performed followed by 10 sets of 10 squats followed by jumps.
15972385|NCT03094663|Drug|Bupivacaine|0.5% with epinephrine 30cc
15972386|NCT03094663|Drug|Methylprednisolone|40 mg/ml, 1 ml
15972387|NCT03094663|Drug|Cefazolin|500 mg in 10 ml
15972388|NCT03094663|Device|8 MHz. Chiba needle|22G/ 4 inches
15972389|NCT03094663|Drug|15 cc of bupivacaine 0.25% with 2 mg of preservative free Dexamethasone|15 cc of bupivacaine 0.25% with 2 mg of PF Dexamethasone
15972390|NCT03094663|Drug|25 cc 0.25% bupivacaine|25 cc 0.25% bupivacaine
15972391|NCT03094663|Drug|20cc 0.25% bupivacaine|20cc 0.25% bupivacaine
15972392|NCT03094663|Drug|2 mg IV dexamethasone.|2 mg IV dexamethasone.
15972393|NCT03094663|Drug|bupivacaine 0.5% with epinephrine 30cc|bupivacaine 0.5% with epinephrine 30cc
15972394|NCT03094650|Device|MindMotion PRO|Patients will receive five weeks of therapy with 2 sessions (minimum) per week lasting for 45-60 minutes each minimum. The training sessions are based on the MindMotion PRO's virtual reality exercises.
15972397|NCT03094624|Other|Neuropsychological and neurophysiological tests|Neuropsychological tests consist in listening to sounds in various contexts and providing behavioral responses with response-buttons. Neurophysiological tests consist in the recording of EEG and/or MEG signals or MRI images while realizing the neuropsychological tests, as well as anatomical MRI scanning to characterize the participants' brain anatomy and reconstruct the brain sources of surface EEG/MEG signals.
15972398|NCT03094624|Other|Experiment 1|Experiment 1 are interested in perception and musical memory vs. Language and contribute to our understanding of the functional and structural organization of the brain to perceive and memorize music and language.
15972399|NCT03094624|Other|Experiment 2|Experiment 2 focuses on perception and musical memory vs. Language and contribute to our understanding of the functional and structural organization of the brain to perceive and memorize music and language. The second experiment will also study short-term memory networks for musical and verbal materials, but the specificity will be the inclusion of a verbal material sung, thus representing the combination of both information. Experiment 2 is divided into two sub-parts. Indeed, the investigators will develop the musical and verbal materials during a first experimental part in experiment (experiment 2a) and then apply them in experimentation MEG (experiment 2b). Experiment 2a will allow us to test new equipment in a short term memory task under conditions that are less restrictive for the participants. Then the investigators will apply the optimal material that emerges for the MEG experiment.
15972400|NCT03094624|Other|Experiment 3|Experiment 3 will use Discordant Negativity (MMN; Mismatch Negativity) protocols in coupled EEG-MEG (experiment 3a) and EEG alone (experiment 3b) to investigate memory traces of sensory information. The MMN is used to probe auditory sensory memory (pre-requisite for short- or long-term storage), and has the advantage of being measured without requiring an active task from the participant.
15972401|NCT03094624|Other|Experiment 4|"Experiment 4 will study the neural correlates of long-term memory for musical and verbal material with fMRI. The testimonies of the amusicians suggest a deficit of the musical lexicon which contrasts with that the musical lexicon elaborated of the non-musician listeners."
15972402|NCT03094611|Biological|Inotuzumab Ozogamicin|Given IV
15972403|NCT03094598|Other|Leaflet|The length is 1.5 A4 pages, Flesch's Reading Ease Score (RES) is 57 (fairly difficult, comparable to a quality magazine), and Human Interest Score (HIS) is 37 (interesting, comparable to a digest magazine).
15972404|NCT03094598|Other|Brochure|The length is 2.5 A4 pages, RES is 43 (difficult, comparable to an academic magazine), and HIS is 25 (interesting, comparable to a digest magazine).
15972405|NCT03094598|Other|Booklet|The length is 12 A4 pages, RES is 11 (very difficult, comparable to a scientific magazine), and HIS is 22 (mildly interesting, comparable to a trade magazine).
15972406|NCT03094585|Other|Written and oral information|The written information (booklet) was 12 A4 pages long and took about 15 minutes to read. The oral information consisted of group sessions which focused on active feedback. Each session was lead by one of the authors who first went through the topics described in the booklet. The review of the topics was followed by a plenary discussion.
15972407|NCT03094585|Other|Written information|The written information (booklet) was 12 A4 pages long and took about 15 minutes to read.
15972408|NCT03094572|Other|visual motor tasks|"This exercise involves manipulating an object that corresponds to a racket, this racket has a virtual avatar that animated a virtual ball. The purpose is to make it bounce to a given height. This comes close to ping-pong game."
15972409|NCT03094559|Device|FlowMet|The FlowMet device will be placed on the index finger of the right hand. Signal fidelity will be assured by confirming the presence of a pulse waveform if one is expected and by assuring that an appropriate amount of light is be detected by the FlowMet device. Following placement of the FlowMet device, a period of 10 seconds will be allowed to elapse to allow transient changes in perfusion due to device placement to diminish. FlowMet blood flow data will be recorded for 20 seconds using the FlowMet data acquisition software. These steps will be repeated for digits 1 and 2 on the limb with diagnosed or suspected CLI, or on both limbs if both are diagnosed or suspected of having CLI.
15972410|NCT03094546|Dietary Supplement|Polyamine|12 months of polyamine supplementation (6 capsules/day)
15972411|NCT03094546|Dietary Supplement|Placebo|12 months of placebo intake (6 capsules/day)
15972412|NCT03094533|Drug|TIVA|total intravenous anesthesia with propofol
15972413|NCT03094533|Drug|VIMA|volatile induction and maintenance anesthesia with sevoflurane
15972414|NCT03094520|Device|tDCS|Transcranial direct current stimulation (tDCS)
15972415|NCT03094520|Device|sham-tDCS|sham stimulation
15972416|NCT03094507|Drug|Tivicay|50 mg once daily
15972417|NCT03094507|Drug|Rezolsta|darunavir 800 mg/cobicistat 150 mg once daily
15972418|NCT03094494|Other|none intervention|none intervention
15972419|NCT03094481|Procedure|SCPB|Bupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided Superficial Cervical Plexus Block at C4 or C5.
15972420|NCT03094481|Procedure|ISB|Bupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided Interscalene Brachial Plexus Block at C5 or C6.
15972421|NCT03094481|Procedure|SCPB + ISB|Bupivacaine hydrogen chloride Inj 0.5% epinephrine. 10ml injected for US guided SCPB at C4 or C5 + 10ml injected for ISB at C5 or C6.
15972422|NCT03094481|Drug|Bupivacaine hydrogen chloride , epinephrine|Bupivacaine hydrogen chloride Inj 0.5% (1:200,000) epinephrine
15972423|NCT03094468|Drug|P-3058 (terbinafine hydrochloride 10%)|Patients will apply the P-3058 nail solution once weekly in a double blind fashion. The overall treatment phase is of 48 weeks.
15972424|NCT03094468|Drug|Vehicle of P-3058|Patients will apply the Vehicle of P-3058 once weekly in a double blind fashion. The overall treatment phase is of 48 weeks.
15972425|NCT03094455|Other|Experimental group|Observation of video sequences showing uni¬manual or bimanual goal-directed actions followed by the execution of the observed actions either with plegic upper limb for unimanual or with both upper limbs for bimanual actions.
15972426|NCT03094442|Drug|Dexamethasone|An 8 mg dose of Dexamethasone is administered at the time of induction of general anesthesia. The medication is provided by the pharmacy in a blinded syringe.
15972427|NCT03094442|Drug|Normal saline|Normal saline contains 0.9% weight/ volume of sodium chloride. It is used routinely for intravenous resuscitation and fluid maintenance. Patients in the placebo arm will receive 2 ml of normal saline in the blinded syringe provided by the pharmacy.
15972428|NCT03094429|Drug|NaBen®|2000 mg/day or 1000 mg/day, twice daily
15972429|NCT03094429|Other|Placebo|0 mg total, twice daily
15972430|NCT03094416|Drug|levothyroxine sodium capsule|after the run-in period, patients will be switched to levothyroxine sodium capsule at the same dose used during run-in
15972431|NCT03094416|Drug|Proton pump inhibitor|for the whole study duration all subjects will keep taking their proton pump inhibitor medication, as per prescription and as before inclusion
15972432|NCT03094416|Drug|Levothyroxine Sodium Tablets|during the run-in period, subjects will continue taking their levothyroxine sodium tablet medication as per prescription and as before inclusion
15972433|NCT03094403|Drug|Azelaic Acid 15% topical gel|Gel
15972434|NCT03094403|Drug|Finacea® (azelaic acid) Gel, 15%|Gel
15972435|NCT03094403|Drug|Placebo|Gel
15972436|NCT03094377|Other|Multisensory therapy|Sensory stimulation, motor training and ADL training
15972437|NCT03094377|Other|Conventional training|Motor training and ADL training
15972438|NCT03094364|Behavioral|Gaming CI Therapy|Intensive remote (via video game) therapy for upper extremity hemiparesis.
15972439|NCT03094351|Procedure|esophagectomy|Robot assisted esophagectomy with extended two field lymphadenectomy.
15972440|NCT03094351|Procedure|esophagectomy|Conventional thoracoscopic esophagectomy with extended two field lymphadenectomy.
15972441|NCT03094338|Behavioral|stress, psychological|students respond to questionnaires
15972443|NCT03094325|Device|Pre Operative Transesophageal echocardiography (TEE) imaging|Center tendency parameters(mean, standard deviation) will be reported for each outcome.
15972444|NCT03094325|Device|Post Operative On-pump intraoperative echocardiography|Center tendency parameters(mean, standard deviation) will be reported for each outcome.
15972445|NCT03094325|Device|Post Operative Transesophageal echocardiography (TEE) imaging|Center tendency parameters(mean, standard deviation) will be reported for each outcome.
15972446|NCT03094312|Procedure|Dynamic Spectral Imaging (ISD)|cerebral stimulation: dynamic spectral imaging (ISD)
15972447|NCT03094286|Drug|Durvalumab|Durvalumab monotherapy of 1500mg every 4 weeks in solid tumors in HIV-1-infected patients until progression significant clinical deterioration, unacceptable toxicity, any criterion for withdrawal from the trial or trial drug is fulfilled
15972448|NCT03094273|Procedure|Saucerization biopsy|2 mm saucerization biopsy of dysplastic nevi
15972449|NCT03094260|Device|High intensity bright light therapy|"Treatment with light therapy in high intensity (10,000 lux), daily for 30 days between 6 am and 9 am for 30 minutes.
~Le device is placed at arm's length (at approximately 50-75cm from the eyes) within the field of vision. The light must bathe the face To ensure the light reaches your eyes, this appliance has a stand that can be set to a variable angle. If subject is sitting higher or standing and the top edge of the appliance is below eye level, the appliance will be placed in a tilted position so that its light points further upwards and reaches the eyes. If subject is sitting at a table or desk and the top edge of the appliance is above eye level. The appliance can be placed in a more upright position."
15972450|NCT03094260|Device|Low intensity light therapy|"Treatment with light therapy in low intensity (<500 lux), daily for 30 days between 6 am and 9 am for 30 minutes.
~Le device is placed at arm's length (at approximately 50-75cm from the eyes) within the field of vision. The light must bathe the face To ensure the light reaches your eyes, this appliance has a stand that can be set to a variable angle. If subjectis sitting higher or standing and the top edge of the appliance is below eye level, the appliance will be placed in a tilted position so that its light points further upwards and reaches the eyes. If subject is sitting at a table or desk and the top edge of the appliance is above eye level. The appliance can be placed in a more upright position."
15972451|NCT03094247|Drug|Amoxicillin|All patients with severe acute malnutrition will receive a course of amoxicillin.
15972452|NCT03094247|Dietary Supplement|HO-RUTF|HO-RUTF: Milk, perilla oil, palm oil, white sugar, high oleic peanuts
15972453|NCT03094247|Dietary Supplement|D-HO-RUTF|D-HO-RUTF: DHA, milk, perilla oil, palm oil, white sugar, high oleic peanuts
15972454|NCT03094247|Dietary Supplement|S-RUTF|S-RUTF: Milk, canola oil, palm oil, white sugar, standard peanuts
15972455|NCT03094234|Device|8mm-TIPS|Patients in this group would underwent TIPS placement with 8mm-diameter ePTFE-covered stents.
15972456|NCT03094234|Procedure|endoscopic variceal ligation (EVL)|Patients in this group would underwent sequential endoscopic variceal ligation and propranolol treatment.
15972457|NCT03094234|Drug|Propranolol|Appropriate dose of propranolol was administered to the patients.
15972458|NCT03094221|Device|Rhythmia Mapping System|Arrhythmia mapping will be performed using the Rhythmia mapping system, including its mapping catheter, either in the atria or ventricles depending on the clinical arrhythmia being treated. Detailed mapping will be performed to determine tissue voltage and arrhythmia mechanism/location according to standard clinical practice. This part of the study will take approximately 90-120 minutes. The catheter position and contact will be visualized with intra-cardiac echocardiography, which is also routinely used during these procedures, and to monitor for potential clinically related complications. Images will be recorded to establish criteria for mapping.
15972459|NCT03094208|Other|dual task balance training|balance exercises with cognitive and motor dual tasks
15972460|NCT03094208|Other|traditional balance training|balance exercises
15972461|NCT03094195|Drug|EMA401|EMA401
15972462|NCT03094195|Drug|Placebo|Placebo
15972463|NCT03094182|Drug|Iron Isomaltoside 1000|Randomly selected patients of the monofer group are given 1000mg of iron isomaltoside, which are mixed in 100ml normal saline, intravenous after induction for 30 minutes.
15972464|NCT03094182|Drug|Normal saline|Randomly selected patients in the control group receive an equivalent volume of normal saline as a placebo.
15972465|NCT03094169|Drug|AVID100 IV|AVID100 is administered once every 3 weeks
15972466|NCT03094156|Drug|Placebo|1 capsule of placebo [to be taken orally, with 240 mL of potable water]
15972467|NCT03094156|Drug|BIA 6-512|1 capsule of BIA 6-512 25mg or 1 capsule of BIA 6-512 50 mg or 1 capsule of BIA 6-512 75 mg or 1 capsule of BIA 6-512 100 mg [to be taken orally, with 240 mL of potable water]
15972468|NCT03094156|Drug|Madopar® 250|Levodopa/benserazide immediate release tablets 200mg/50mg [to be taken orally, with 240 mL of potable water]
15972469|NCT03094156|Drug|Comtan®|Entacapone 200 mg tablets [to be taken orally, with 240 mL of potable water]
15972470|NCT03094143|Procedure|Aortic valve intervention|The choice of either surgical aortic valve replacement or transcatheter aortic valve implantation (TAVI) will be made by the local clinical team according to local policies. In patients undergoing surgical replacement the choice of surgical technique and type of valve replacement used will be at the discretion of the operating surgeon. Patients found to have significant coronary artery disease requiring concomitant coronary artery bypass surgery will not be excluded. Similarly the choice of TAVI valve and need for percutaneous coronary intervention will be made by the TAVI heart team. The procedure should be performed as soon as possible and ideally within four months of randomisation and allocation to group A.
15972471|NCT03094130|Other|News items with spin|Interpretation of news items with spin
15972472|NCT03094130|Other|News items without spin|Interpretation of news items without spin
15972473|NCT03094117|Other|News items with spin|Interpretation of news items with spin
15972474|NCT03094117|Other|News items without spin|Interpretation of news items without spin
15972475|NCT03094104|Other|News items with spin|Interpretation of news items with spin
15972476|NCT03094104|Other|News items without spin|Interpretation of news items without spin
15972477|NCT03094091|Other|News items with spin|Interpretation of news items with spin
15972478|NCT03094091|Other|News items without spin|Interpretation of news items without spin
15972479|NCT03094078|Other|News item with spin|Interpretation of news item with spin
15972480|NCT03094078|Other|News item without spin|Interpretation of news item without spin
15972486|NCT03094052|Drug|Diphenoxylate Hydrochloride/Atropine Sulfate|Given PO
15972487|NCT03094039|Procedure|Ventilatory support while attached to the cord|Infants will receive active resuscitative care (intubation and ventilation) using a specific designed platform for 120 seconds during delayed cord clamping. Then the cord will be clamped forgoing resuscitation care.
15972488|NCT03094039|Procedure|Immediate cord clamping|Infants will receive immediate cord clamping, transferred to the resuscitation table, intubated and mechanical ventilated according to our current Congenital Diaphragm Hernia protocol.
15972489|NCT03094026|Behavioral|Lumosity|Computer-based online cognitive training program using the Lumosity cognitive training program.
15972490|NCT03094026|Behavioral|Lumosity (waitlist control)|Computer-based online cognitive training program using the Lumosity cognitive training program. The control group will receive the intervention after a waiting period of 12 weeks.
15972491|NCT03094013|Other|Assessment|Assessment
15972492|NCT03094000|Behavioral|MIND|"Both experimental and control groups receive 20 weekly sessions (1.5 hours each), based on principles of CBT-E (Fairburn, 2008), adapted for a group format .
~The experimental group will receive in addition to CBT-E a mindfulness based intervention comprising of 4 weekly group sessions (1.5 hours each) during the month prior to the CBT-E program. The mindfulness skills intervention will also be practiced throughout the CBT-E program at the beginning of every group session and independently as homework. Mindfulness intervention includes formal mindfulness practice (brief mindfulness meditation - 10 minutes each) and informal mindfulness practice (Other non meditation exercises, also known as mindfulness in everyday life- eg STOP)."
15972493|NCT03094000|Behavioral|CBT-E|The comparison group (control) will receive 4 weekly supportive-educational group sessions (1.5 hours each) prior to the group CBT-E program, with no mindfulness content or training.
15972494|NCT03093987|Other|Critical care ultrasound|Circulateory will be managed according to the result of critical ultrasound joint clearance of lactic acid in patients with shock
15972495|NCT03093974|Drug|Colistimethate Sodium|1 M units equivalent to 80 mg colistimethate sodium diluted in 1 mL saline solution 0.45%
15972496|NCT03093974|Drug|Saline Solution|1 ml saline solution 0.45%
15972497|NCT03093961|Device|IASD implant|Single arm for implant
15972498|NCT03093948|Procedure|Remote ischemic post-conditioning|Remote ischemic post-conditioning will undergo in both thighs at the beginning of targeted temperature management. This will be done with noninvasive measurement of blood pressure, with cuffs inflated to 200 mmHg for four 5 min cycles and interrupted three times for 5 min with cuff deflation.
15972499|NCT03093935|Device|StimRouter Neuromodulation System|The StimRouter Neuromodulation System is indicated for pain management in adults who have severe intractable chronic pain of peripheral nerve origin, as an adjunct to other modes of therapy (e.g., medications). The StimRouter is not intended to treat pain in the craniofacial region.
15972500|NCT03093922|Drug|Atezolizumab|1200 mg/m^2
15972501|NCT03093922|Drug|Gemcitabine|1000 mg/m^2
15972502|NCT03093922|Drug|Cisplatin|70 mg/m^2
15972503|NCT03093909|Drug|Gemcitabine|Nebulized dose of aerosol GCB twice a week continuously (escalating treatment dose schema, starting at 0.75 mg/kg to 3.0 mg/kg). Participants receive a pre-determined volume of nebulized solution, according to the dose level and weight of the participant, with each aerosol GCB administration. One cycle is 4 weeks in duration.
15972504|NCT03093896|Dietary Supplement|snack mix|commercial cereal mix with bits of beef jerky and coconut
15972505|NCT03093896|Dietary Supplement|almonds, 1.5 oz|almonds, 1.5 oz/day
15972506|NCT03093896|Dietary Supplement|almonds, 3 oz|almonds, 3.0 oz/day
15972507|NCT03093883|Drug|Ferrinemia|Test product Ferrinemia will be administered intravenously via a 18 gauge (18G) needle. For intravenous injection, a 5 mL single dose of test product (each mL containing 20 mg/mL elemental iron as iron sucrose in water for injection) will be diluted in 0.9% isotonic sterile sodium chloride (NaCl) up to 15 mL. The injection solution will be intravenously administered to the forearm vein, resulting in a total injection volume of 15 mL administered over a period of 5 minutes.
15972508|NCT03093883|Drug|Venofer|Reference product Venofer will be administered intravenously via a 18 gauge (18G) needle. For intravenous injection, a 5 mL single dose of test product (each mL containing 20 mg/mL elemental iron as iron sucrose in water for injection) will be diluted in 0.9% isotonic sterile sodium chloride (NaCl) up to 15 mL. The injection solution will be intravenously administered to the forearm vein, resulting in a total injection volume of 15 mL administered over a period of 5 minutes.
15972509|NCT03093870|Drug|Varlitinib|Varlitinib:300mg, oral tablets, twice daily. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death.
15972510|NCT03093870|Drug|Capecitabine|1000mg/m2, oral tablets, twice daily for 2 weeks followed by a 1-week rest period in 3-week cycles. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death.
15972511|NCT03093870|Drug|Placebo (for Varlitinib)|oral tablets, twice daily. Number of cycles: until disease progression, unacceptable toxicity, withdrawal of consent, or death
15972512|NCT03093857|Diagnostic Test|Determination of biomarker|Liquor, blood, and urine samples will be drawn and measured at different time points.
15972513|NCT03093844|Device|Miltenyi CliniMACS® CD34 Reagent System|Miltenyi CliniMACS® CD34 Reagent System will be used to prepare CD34+ enriched/T-cell depleted cells from haploidentical mobilized peripheral blood.
15972514|NCT03093831|Drug|Ibrutinib|560mg administered orally once daily.
15972515|NCT03093818|Other|Pharmacogenomic testing|"The pharmacogenomic panel to be used incorporates 48 genetic variants for the following 13 pharamacogenes: CYP2B6 (cytochrome P450), CYP2C19, CYP2C9, CYP2D6,CYP3A4, DPYD (dihydropyrimidine dehydrogenase), FVL (factor five Leiden), HLA-B (human leukocyte antigen), NUDT15 (Nudix hydrolase), SLCO1B1 (solute carrier organic anion transporter), TPMT (thiopurine methyltransferase), UGT1A1 (UDP-glucuronosyltransferase), and VKORC1 (vitamin K epoxide reductase complex)."
15972516|NCT03093805|Dietary Supplement|Calcipotriene|Topical vitamin D cream will be applied to affected areas of the skin.
15972517|NCT03093792|Other|Control|
15972518|NCT03093792|Other|American Heart Association plus exercise|
15972519|NCT03093792|Other|Curves Complete - I plus exercise|
15972520|NCT03093792|Other|Curves Complete - II plus exercise|
15972521|NCT03093779|Other|Health Information Assessment|Assess how hearing loss and health literacy alters the ability to access and comprehend online health information
15972522|NCT03093753|Other|Control (study 1)|Control meal will comprise of 50 g glucose dissolved in 200 ml water, to which the response of the test meals will be compared to
15972523|NCT03093753|Other|Test (study 1)|The test meal will comprise 50 g glucose in 200 ml water plus 50 mg oleuropein from olives
15972524|NCT03093753|Other|Control (study 2)|Control meal will comprise 109 g white bread to give 50 g available carbohydrate and 200 ml water, to which the response of the test meals will be compared to
15972525|NCT03093753|Dietary Supplement|Test (study 2)|The test meal will comprise 109 g white bread plus 50 mg oleuropein from olives dissolved in 200 ml water
15972526|NCT03093753|Other|Control (study 3)|Control meal will comprise whole-meal bread to give 50 g available carbohydrate and 200 ml water, to which the response of the test meals will be compared to
15972527|NCT03093753|Dietary Supplement|Test (study 3)|The test meal will comprise whole-meal bread plus 50 mg oleuropein from olives dissolved in 200 ml water
15972528|NCT03093753|Other|Control (study 4)|Control meal will comprise 50 g sucrose in 200 ml water, to which the response of the test meals will be compared to
15972529|NCT03093753|Dietary Supplement|Test (study 4)|The test meal will comprise 50 g sucrose in 200 ml water plus 50 mg oleuropein from olives
15972530|NCT03093753|Other|Control (study 5)|Control meal will comprise 25 g sucrose in 200 ml water, to which the response of the test meals will be compared to
15972531|NCT03093753|Other|Test (study 5)|The test meal will comprise 25 g sucrose in 200 ml water plus 160 mg oleuropein from olives
15972532|NCT03093753|Other|Control (study 6)|Normal diet 3 days prior to the visit day and 109 g bread with 200 ml water on the study day
15972533|NCT03093753|Other|Test (study 6)|High carbohydrate diet (23% fat, 55% carbohydrates and 22% protein) 3 days prior to the visit day and 109 g bread with 200 ml water on the study day
15972534|NCT03093753|Other|Control (study 7)|Normal diet 3 days prior to the visit day and 109 g bread with 200 ml water on the study day
15972535|NCT03093753|Other|Test (study 7)|High fat diet (44% fat, 34% carbohydrates and 22% protein) 3 days prior to the visit day and 109 g bread with 200 ml water on the study day
15972536|NCT03093740|Drug|Zepatier|Based on negative viral resistance testing of the donor treatment will be Zepatier
15972537|NCT03093740|Drug|Zepatier plus Sofosbuvir|Based on positive viral resistance testing of the donor treatment will be Zepatier with Sofosbuvir
15972538|NCT03093714|Drug|FDL169|CFTR corrector
15972539|NCT03093714|Drug|Placebo|Placebo for FDL169
15972540|NCT03093701|Drug|TLC399 (ProDex)|2-vial system: TLC399-DSP and TLC399-Lipid
15972541|NCT03093688|Biological|Infusion of iNKT cells and CD8+T cells|The eligible patients receive twice infusions of iNKT cells(1E8~1E10) and CD8+T cells(1E7~1E9) in one course of treatment.
15972542|NCT03093675|Device|TELELAP ALF-X Robotic Surgical System|The surgical procedures will be performed using the innovative TELELAP ALF-X robotic system, equipped with multiple independent arms. Initial entry will be through a classic open in which the arm with the video camera will be inserted. The device has four independent arms (one for the video camera and three for surgical instruments). Patients will be in the lithotomy position, supported by Allen stirrups and under general anesthesia. The uterus will be manipulated with a multi-use uterine manipulator. After having induced a pneumoperitoneum, high-definition 3D-technology optics will be inserted. Three laparoscopic instruments will be used to complete the procedure. Standard techniques will be used.
15972543|NCT03093662|Device|Ventilation with nasal cannula|Subject is fitted with a face mask and undergoes three continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear) while simultaneously wearing nasal cannula (Carefusion AirLife Standard Nasal Cannula) with 15 L/min oxygen flow. Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E).
15972544|NCT03093662|Device|Ventilation without nasal cannula|Subject is fitted with a face mask and undergoes three continuous minutes of positive pressure ventilation (Respironics AF521, EE with CapStrap headgear). Subject then removes mask and immediately exhales into an oxygen sensor (Maxtec Max-250E).
15972545|NCT03093649|Other|adverse events using patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire|The intervention was administrated through APP
15972546|NCT03093649|Other|do not report adverse events through patient-reported outcomes version of common terminology criteria for adverse events (PRO-CTCAE) questionaire|patients receive normal care and visit
15972547|NCT03093636|Device|Continuous Glucose Monitor (CGM)+Decision Support System (DSS)|"Continuous Glucose Monitor (CGM)+Decision Support System (DSS) study participants will use the inControl Advice App and a study CGM at home for 12 weeks. The DSS contains a smart bolus advisor that adjusts the size of the correction insulin boluses based on short-term blood glucose predictions. It is able to complete this function by evaluating CGM values, insulin usage and carbohydrate intake record. It also contains an exercise advisor, a bedtime advisor, hypoglycemia risk and long-term tracker of HbA1c. Subjects will use study basal and bolus insulin during the study."
15972548|NCT03093636|Other|Continuous Glucose Monitor (CGM) alone|Continuous Glucose Monitor (CGM) alone study participants will use a study CGM at home for 12 weeks. Subjects will use study basal and bolus insulin during the study.
15972549|NCT03093623|Behavioral|Physical activity|In physical activity experimental group, trained study nurses will interview with patients,give health education,teach how to use and record the Activity meter.Professionals will calculate Metabolic Equivalent of Task(MET) with formula weekly.MET = (intensity level 9 points * time of each exercise (hours) * Number of times per week + moderate level 5 points * time per activity (hours) * number of times per week + low level 3 points * time per activity (hours) * number of times per week),investigators hope patients in the first month MET can reach (3.75-7.49 MET-h/ week), and reach moderate or more than moderate activity (>= 7.5-16.49 MET-h/ week) at the starting of second month for at least one year.
15972550|NCT03093610|Procedure|Traditional|Removal of the chest tube after air leakage has ceased and fluid drainage is 200ml/24h or less.
15972551|NCT03093610|Procedure|Test|Removal of the chest tube after air leakage has ceased and fluid drainage is 5ml/kg/24h or less.
15972552|NCT03093597|Other|virgin coconut oil|One of the four locations (right proximal forearm, right distal forearm, left proximal forearm, left distal forearm) on the forearm will be selected to receive virgin coconut oil application twice daily for 2 weeks.
15972668|NCT03092830|Genetic|Molecular testing of DNA/RNA from skin tumors, SCC/BCC|Molecular testing of DNA/RNA from skin tumors, SCC/BCC
15972553|NCT03093597|Other|virgin jojoba oil|One of the four locations (right proximal forearm, right distal forearm, left proximal forearm, left distal forearm) on the forearm will be selected to receive virgin jojoba oil application twice daily for 2 weeks.
15972554|NCT03093597|Other|virgin almond oil|One of the four locations (right proximal forearm, right distal forearm, left proximal forearm, left distal forearm) on the forearm will be selected to receive virgin almond oil application twice daily for 2 weeks.
15972555|NCT03093597|Other|white petrolatum ointment|One of the four locations (right proximal forearm, right distal forearm, left proximal forearm, left distal forearm) on the forearm will be selected to receive white petrolatum ointment application twice daily for 2 weeks.
15972556|NCT03093584|Device|Auricular acupuncture|Auricular acupuncture with indwelling fixed auricular acupuncture needles
15972557|NCT03093584|Behavioral|Expressive writing|Expressive writing is a standard psychological method in treatment of exam anxiety
15972558|NCT03093571|Device|Auricular stimulation|Auricular stimulation with indwelling fixed needles
15972559|NCT03093571|Behavioral|Relaxation|Progressive muscle relaxation
15972560|NCT03093558|Behavioral|ECA/Kardia|Use of the ECA and Kardia daily for 30 days.
15972561|NCT03093545|Biological|Equine Rabies Immunoglobulin|40 IU per kg of body weight of ERIG at Day 0
15972562|NCT03093545|Biological|Purified chick-embryo cell rabies vaccine|1 ml of PCEC Rabies vaccine on days 0, 3, 7, 14 and 28.
15972563|NCT03093532|Other|ED SBIRT-HTN|"Participants in the ED-SBIRT-HTN group will receive the following interventions:
~1) screening (risk assessment/stratification), 2) a limited bedside echocardiogram (looking for evidence of subclinical cardiac disease), and 3) a urine microalbumin test (marker of early cardiovascular disease)."
15972564|NCT03093532|Other|PACHT-c|Participants randomized to the SBIRT-HTN +PACHT-c (Post-Acute Care Hypertension Transition Clinic) arm will receive all interventions of the ED SBIRT-HTN arm plus a 48-72 hour follow-up in the Post-Acute Care Hypertension Transition Clinic for repeat blood pressure assessment, review of screening assessments, and secured PCP appointment with a federally qualified health center within the study site's health system.
15972565|NCT03093519|Drug|KHK6640|Intravenous administration
15972566|NCT03093519|Drug|Placebo|Intravenous administration
15972567|NCT03093506|Drug|Low-dose rhEpo|60IU/kg/week
15972568|NCT03093506|Drug|Micro-dose rhEpo|20IU/kg/week
15972569|NCT03093506|Other|Placebo Control|Saline
15972570|NCT03093493|Diagnostic Test|Genotyping|Genotyping by next generation sequencing
15972571|NCT03093480|Biological|rFVIIIFc|rFVIIIFc 200 IU/kg/day in ITI Period, 50 or 100 IU/kg (adjusted according to Investigator judgement) in tapering Period, and prophylactic regimen in Follow-Up period as powder for injection administered intravenously.
15972572|NCT03093467|Behavioral|ASCENSO|Internet-based program: an adjunct support and monitoring system for the treatment of depression.
15972573|NCT03093467|Drug|Antidepressants or in combination with anxiolytics, neuroleptics or mood stabilizers.|Usual psychiatric treatment which may include drugs: antidepressant monotherapy or antidepressants in combination with anxiolytics, neuroleptics or mood stabilizers as needed, according to the psychiatric evaluation. Monthly controls during 5 months in average.
15972574|NCT03093467|Behavioral|Psychotherapy|Usual treatment: brief psychotherapy. One session per week, a total of 9 sessions in average.
15972575|NCT03093454|Drug|Lavender Essential Oil|Lavender essential oil will be applied topically and by inhalation to the lavender group.
15972576|NCT03093441|Other|Multimodal High-Intensity Interval Training Intervention|The intervention will occur 3 times per week for 12 weeks and include a warm-up, MM-HIIT or R-HIIT training protocol, and a cool down.
15972577|NCT03093428|Drug|Radium-223|Radium-223 is a calcium mimetic that hones in on bone metastases. It binds to new bone stroma and emits alpha particles, which induce double-stranded DNA breaks that result in tumor cell death.
15972578|NCT03093428|Drug|Pembrolizumab|Pembrolizumab is a PD-1 inhibitor
15972579|NCT03093415|Drug|elbasvir-grazoprevir (50 mg/100 mg)|12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)
15972580|NCT03093402|Drug|JBT-101|Participants will self-administer JBT-101 by mouth (orally), at prescribed dose and frequency per protocol, Days 1-84. Administration of dose(s) should be at least 8 hours apart.
15972581|NCT03093402|Drug|Placebo|Participants will self-administer JBT-101 placebo by mouth (orally), at prescribed dose and frequency per protocol, Days 1-84. Administration of dose(s) should be at least 8 hours apart.
15972582|NCT03093389|Drug|BIA 6-512|The investigational products consisted of capsules containing BIA 6-512 25 mg, 50 mg, 100 mg and 150 mg. Products were administered orally, with approximately 240 mL of water in case of Doses 1 and 13, and at least 150 mL of water in case of Doses 2 to 12. First dose (Dose 1) and last dose (Dose 13) were administered in fasting of at least 8 hours and subject remained fasted until to 2.5 h post-dose. Meals were not served within 1 hour prior and 1 hour after investigational product administration in Doses 2 to 12
15972583|NCT03093389|Drug|Placebo|Matching placebo capsules
15972584|NCT03093376|Behavioral|Effortful Control Camp|"An interactive, child-friendly camp. Effortful control (EC) camp is comprised of short, game-like exercises taught by camp counselors to groups of approximately 4-6 children. In total, 12 different exercises that teach inhibitory and attentional control, as well as visuospatial and working memory skills, will be administered.
~Tasks will allow for scaffolding (Halperin et al, 2013), or incremental increases in difficulty of the games over time. EC camp will occur over 4 mornings from 9AM to 12PM, on two consecutive weekends."
15972585|NCT03093363|Other|Pharmacist's intervention|"Pharmacist's intervention with asthmatic patients:
~Detailed questionnaire on asthma and treatments (atopy, comorbidities, smoking status, asthma control, adverse effects of treatments, etc.)
~Explanation of asthma and inflammation
~Explanation of triggers and how to avoid it
~Explanation of asthma treatments
~Explanation of the inhalation technique with a physical demonstration
~Emphasis on treatment adherence
~Assessment of comorbidities and their treatment
~Emphasis on influenza vaccination"
15972586|NCT03093363|Other|Questionnaires for control group|- Detailed questionnaire on asthma and treatments (atopy, comorbidities, smoking status, asthma control, adverse effects of treatments, etc.)
15972669|NCT03092817|Drug|Dexamethasone|Active treatment with dexamethasone from randomisation (IV followed by oral according to disease severity at the start of treatment): dexamethasone for intravenous injection and dexamethasone for oral ingestion
15972587|NCT03093350|Biological|TAA-specific CTLs|"Each patient will receive 2 injections at a fixed dose, 28 days apart, according to the following dose schedule: The expected volume of infusion will be 1 to 10 cc.
~Dose schedule:
~Day 0: 2 x 10^7 cells/m2
~Day 28: 2 x 10^7 cells/m2
~If patients have stable disease or a partial response by the Response Evaluation Criteria in Solid Tumors (RECIST) criteria at their 6 week evaluation after the 2nd cell dose, they will be eligible to receive up to 6 additional doses of CTLs, At least one month should have passed before each additional dose.. Each additional infusion will consist of the same cell number or less (if there is not enough product available for the subject's original dose) than their second infusion. Patients will not be able to receive additional doses until the initial safety profile is completed at 6 weeks following the second infusion."
15972588|NCT03093337|Other|Early post hospital discharge psychomotor therapy|The intervention consisted on 20 psychomotor therapy sessions between 2 and 9 months, in order to support infants' development, and parent-infant interactions and adjustment. The therapy was based on body and emotional positive feelings and experiences, leading to improve sensory motor and perceptive integration, interactive and exploratory behaviors, physiological and tonic-emotional self-regulation, motor organization and early coordination. The intervention was a partnership with the parents, leading to decode the baby needs and expectations, for the parents to experiment more positive feelings, to become more confident in their own skills and more sensitive, and in synchrony with their baby. Intervention was supported by a detailed assessment scale implemented in the regional network related to the follow-up for vulnerable babies.
15972589|NCT03093324|Drug|ALKS 8700|Administered as specified in the treatment arm.
15972590|NCT03093324|Drug|Dimethyl Fumarate|Administered as specified in the treatment arm.
15972591|NCT03093311|Other|NIRS based protocol|Each desaturation episode will be managed according to a standardized protocol - correction of extreme head position will be followed by optimisation of mean arterial pressure (MAP), arterial hemoglobin oxygen saturation, end tidal carbon dioxide concentration and a level of hemoglobine concentration.
15972592|NCT03093298|Other|Enteroscopy with biopsy sampling and mixed meal test|Enteroscopies with biopsy retrieval and mixed meal tests with blood sampling before and after Roux-en-Y gastric bypass surgery
15972593|NCT03093272|Drug|Leuprolide Acetate|a GnRH agonist
15972594|NCT03093272|Drug|Prednisone|Prednisone is a corticosteroid
15972595|NCT03093272|Drug|Docetaxel|Docetaxel is an antineoplastic agent that acts by disrupting the microtubular network in cells that is essential for mitotic and interphase cellular functions. Docetaxel binds to free tubulin and promotes the assembly of tubulin into stable microtubules while simultaneously inhibiting their disassembly.
15972596|NCT03093272|Drug|Apalutamide|The apalutamide drug substance is an almost white to slightly brown powder. The tablet formulation of apalutamide is an immediate release oral tablet containing 60-mg of drug substance, with a non-functional green film coat
15972597|NCT03093259|Drug|ABX464|ABX464 is a new Anti-inflammatory drug
15972598|NCT03093259|Drug|Placebo oral capsule|Placebo matching with ABX464
15972599|NCT03093246|Dietary Supplement|Omega-3 polyunsaturated fatty acids|3 g of omega-3 polyunsaturated fatty acids daily supplementation over a period of 180 days
15972600|NCT03093246|Drug|Aspirin|100 mg of aspirin daily supplementation over a period of 180 days
15972601|NCT03093246|Other|Placebo|Placebo pills over a period of 180 days
15972602|NCT03093246|Procedure|Full-mouth ultrasonic debridement|Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
15972603|NCT03093233|Other|no intervention|only descriptive data analysis
15972604|NCT03093207|Procedure|Open flap debridement|Open flap debridement will be performed to decontaminate root surface
15972605|NCT03093207|Other|Placebo|Placebo pills over a period of 180 days
15972606|NCT03093207|Dietary Supplement|Omega-3 polyunsaturated fatty acids|3 g of omega-3 polyunsaturated fatty acids daily supplementation over a period of 180 days
15972607|NCT03093207|Drug|Aspirin|100 mg of aspirin daily supplementation over a period of 180 days
15972608|NCT03093194|Other|vaginal preparation before CS with Septal soap and septol.|vaginal preparation before CS with Septal soap and septol.
15972609|NCT03093194|Other|No vaginal preparation before CS with Septal soap and septol.|No vaginal preparation before CS with Septal soap and septol.
15972610|NCT03093181|Other|Washout / Standard Cleanser|Participants will apply standard cleanser (Simple Kind to Skin Moisturising Facial Wash) twice daily (morning and night) with at least 8 hours between product applications. Participants will use the standard cleanser in a 5-7 day washout period and during the test phase of the study
15972611|NCT03093181|Other|Test product|Participants will apply 0.6 gram (g) of Test product (Moisturising Cream with Niacinamide) twice daily (morning and night) with at least 8 hours between product applications. Participants will use the test product during the test phase of the study.
15972612|NCT03093181|Other|Positive control cleanser|Participants will apply positive control cleanser (Neutrogena Visibly Clear Spot Clearing Facial Wash) twice daily (morning and night) with at least 8 hours between product applications. Participants will use the positive control cleanser during the test phase of the study.
15972613|NCT03093181|Other|Positive control moisturiser|Participants will apply 0.6 g of positive control moisturiser (Vivatinell Acnecinamide Gel Cream) twice daily (morning and night) with at least 8 hours between product applications. Participants will use the positive control moisturiser during the test phase of the study.
15972614|NCT03093168|Biological|Anti-BCMA CAR-T cells|Retroviral vector-transduced autologous T cells to express anti-BCMA CAR
15972615|NCT03093168|Drug|Fludarabine|dose: 25mg/m2/d
15972616|NCT03093168|Drug|Cyclophosphamide|Dose: 40mg/kg
15972617|NCT03093155|Drug|Ixabepilone|"Ixabepilone will be administered at 20 mg/m2 intravenously days 1, 8, 15 of a 28-day cycle over one hour.
~Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response"
15972670|NCT03092817|Other|Placebo|"Treatment with matched placebo:
~Standard saline for intravenous injection and placebo oral tablets containing cellulose"
15972671|NCT03092804|Procedure|ventriculo-peritoneal shunting|A mainstream therapy for NPH. It involves the device of CSF flow control of shunts and accessories(CFDA(I)20143665605)
15972672|NCT03092791|Biological|Sabin-Based Inactivated Poliomyelitis Vaccine (sIPV)|sIPV intramuscular injection
15972673|NCT03092791|Biological|Reference IPV|Reference IPV intramuscular injection
15972618|NCT03093155|Drug|Bevacizumab|"Bevacizumab will be administered at 10 mg/kg intravenously days 1, 15 of a 28-day cycle over one hour. Bevacizumab will be infused after ixabepilone. The first dose of bevacizumab will be administered intravenously over 90 minutes; the second dose may be administered over 60 minutes if no prior reaction to previous infusion; subsequent doses may be administered over 30 minutes if no prior reaction to previous infusion.
~Treatment will continue until progression, death, or prohibitive side effects. If any patient has a complete response, patient may stop treatment after 2 additional consolidation cycles following documented complete response."
15972619|NCT03093142|Device|tDCS & neurofeedback|tDCs and neurofeedback
15972620|NCT03093142|Device|neurofeedback|Neurofeedback
15972621|NCT03093142|Device|sham neurofeedback|sham neurofeedback
15972622|NCT03093129|Drug|artesunate|"Artesunate (Trade name : Arinate®)
~Artemisinins are a family of sesquiterpene trioxane anti-malarial agents derived from Sweet wormwood (Artemisia annua L) that have been used in traditional Chinese medicine for centuries to treat fevers. Artesunate, artemether and arteether are derivatives of artemisinin that are converted into their active metabolite dihydroartemisinin (DHA). Artesunate is approved for the treatment of uncomplicated and multidrug-resistant malaria and is on the WHO list of Essential Medicines (WHO., 2015)."
15972623|NCT03093129|Other|placebo|The matching placebo tablets contain lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica and a magnesium stearate blend.
15972624|NCT03093116|Drug|Oral repotrectinib (TPX-0005)|Oral repotrectinib (TPX-0005) capsules.
15972625|NCT03093103|Drug|Empagliflozin 10 mg|Prescription of empagliflozin 10 mg once a day Follow-up of renal parameters including BOLD MRI
15972626|NCT03093103|Drug|Placebo|Prescription of a placebo once a day Follow-up of renal parameters including BOLD MRI
15972627|NCT03093090|Dietary Supplement|Water|6 oz
15972628|NCT03093090|Dietary Supplement|Parmalat™ Whole Milk|6 oz
15972629|NCT03093090|Dietary Supplement|Similac Pro-Advance™|6 oz
15972630|NCT03093090|Dietary Supplement|Ensure Plus™|6 oz
15972631|NCT03093090|Drug|Furosemide 20 MG|Furosemide is a loop diuretic (water pill) that prevents your body from absorbing too much salt.
15972632|NCT03093077|Device|DePuy ATTUNE total knee arthroplasty system|A standard midvastus approach will be used for both alignment technique groups. This is a standard approach for exposing the knee joint for TKA.
15972633|NCT03093064|Drug|Natalizumab|Natalizumab is a humanized monoclonal antibody against the cell adhesion molecule α4-integrin, currently licensed for the treatment of multiple sclerosis and Crohn's disease.
15972634|NCT03093064|Other|Placebo: normal saline|Normal saline, intravenous infusion
15972635|NCT03093051|Device|Unpinning Termination therapy|Electrotherapy comprised of standard biphasic and monophasic pacing pulses
15972636|NCT03093038|Device|H-MAX stem & Delta-TT cup + polyethylene|H-MAX femoral stem & Delta-TT cup with a polyethylene insert
15972637|NCT03093038|Device|H-MAX stem & Delta-TT cup + ceramic|H-MAX femoral stem & Delta Delta-TT cup with a Ceramic insert
15972638|NCT03093038|Device|C2 stem & Delta-TT cup + ceramic|C2 femoral stem Delta Delta-TT cup with a Ceramic insert
15972639|NCT03093025|Drug|TS-121 10 mg|Orally taken once daily
15972640|NCT03093025|Drug|TS-121 50 mg|Orally taken once daily
15972641|NCT03093025|Drug|Placebo|Orally taken once daily
15972642|NCT03092999|Drug|Vilaprisan (BAY1002670)|2 mg tablet, single dose, oral administration
15972643|NCT03092986|Drug|Paclitaxel|paclitaxel 200 mg/m2 i.v over 3 hrs on day 1, every 21 days for 2 cycles followed by radiotherapy on day 42
15972644|NCT03092986|Drug|Carboplatin|carboplatin AUC 6 iv over 1 hr on day 1 , every 212 days for 2 cycle followed by radiotherapy on day 42
15972645|NCT03092986|Drug|Cisplatin|cisplatin 100 mg/m2 i.v over 2 hrs on day 1 and 29 followed by radiotherapy on day 50
15972646|NCT03092986|Drug|Vinblastine Sulfate|Vinblastin 5mg/m2 i.v on day 1,8,15,22 and 29 followed by radiotherapy on day 50
15972647|NCT03092986|Radiation|three dimensional conformal radiotherapy|three dimensional conformal radiotherapy would be given at day 42 after completion of paclitaxel and carboplatin 2 cycle and at day 50 after completion of cisplatin and vinblastin from d1 to d29
15972648|NCT03092973|Diagnostic Test|Ultrasound|
15972649|NCT03092960|Behavioral|Minimal intensity intervention|The minimal intensity intervention control includes the Group Lifestyle Balance (GLB) videos (DVD or online), standardized messages, and access to a lifestyle coach if initiated by the participant.
15972650|NCT03092960|Behavioral|HOMBRE|HOMBRE is a Group Lifestyle Balance (GLB)-based intervention tailored for men and available in 3 delivery modalities (coach-facilitated individual approach, coach-led online virtual groups, and coach-led in-person groups). A lifestyle coach will support men in making an informed choice of modality and will provide ongoing individualized feedback. All delivery modalities provide the same evidence-based curriculum and include self-monitoring and individualized feedback from the lifestyle coach.
15972651|NCT03092947|Other|No intervention|
15972652|NCT03092934|Drug|LY3295668|Oral capsules
15972653|NCT03092921|Device|F&P Mask Seal|Investigative Mask Seal to be used for OSA therapy
15972654|NCT03092921|Device|F&P Mask|Investigative Mask to be used for OSA therapy
15972655|NCT03092908|Dietary Supplement|mature vinegar|Administer 5 ml mature vinegar (Brand: Ninghuafu) three times a day.
15972656|NCT03092908|Dietary Supplement|placebo (water)|Administer 5 ml placebo (water) three times a day.
15972657|NCT03092895|Biological|SHR-1210|Subjects receive SHR-1210 intravenous at the dose 3mg/kg on Day 1 every 2 weeks
15972658|NCT03092895|Drug|Apatinib|Subjects receive Apatinib orally every day with a dose escalation
15972659|NCT03092895|Drug|FOLFOX4|Subjects receive FOLFOX4 treatment every 2 weeks
15972660|NCT03092895|Drug|GEMOX|Subjects receive GEMOX treatment every 2 weeks
15972661|NCT03092882|Behavioral|Diabetes Self-Management Program|The Diabetes Self-Management Program is a platform that includes a smart meter, access to coaching 24/7, and a mobile app and website that help members manage their diabetes. The program offers diabetes education and coaching delivered entirely through the smart meter and mobile app or website.
15972662|NCT03092869|Other|Feet and Ankle Mobilization|A set of manual therapy mobilization in feet and ankle joints
15972663|NCT03092869|Other|Proprioceptive Training|A set of proprioceptive exercises oriented to improve balance abilities
15972674|NCT03092791|Biological|sIPV Placebo|sIPV placebo-matching intramuscular injection
15972675|NCT03092778|Procedure|Cryoablation|"A computed tomography (CT) scan will be completed to map out where to insert the cryoablation needle. Numbing medicine will be used to numb the skin and deeper tissues before inserting the needle.
~The cryoablation needle will be inserted and directed toward the target area of the vagal nerve. A CT scan will be done during the procedure to help guide the needle which will be held in position by the study doctor(s) once it reaches the target area. With the needle in place, the study doctor(s) will freeze the zone over 3 minutes, a 2 minutes thaw will follow, then 2 more cycles of 3 minutes freeze and 2 minute thaw will complete the procedure. This portion of the procedure can last from 25 to 35 minutes. Once the targeted area has been properly treated, the cryoablation needle will be withdrawn."
15972676|NCT03092765|Drug|E6011|Intravenous administration
15972677|NCT03092765|Drug|Placebo|Intravenous administration
15972678|NCT03092752|Drug|oral antidiabetic drugs|OADs usage conditions and dose selection in T2DM patients
15972679|NCT03092739|Diagnostic Test|PD-L1 Immunocytochemistry (ICC)|PD-L1 expression in the cytological specimens will be assessed using different antibodies.
15972680|NCT03092739|Diagnostic Test|PD-L1 Immunohistochemistry (IHC)|PD-L1 expression in the histological specimens will be assessed using different antibodies.
15972681|NCT03092726|Drug|ASP8062|ASP8062 30 mg was administered orally as a single daily dose, taken preferably in the morning with or without food.
15972682|NCT03092726|Drug|Placebo|Placebo was administered orally as a single daily dose, taken preferably in the morning with or without food.
15972685|NCT03092674|Drug|Azacitidine|Given SC or IV
15972686|NCT03092674|Drug|Cytarabine|Given IV
15972687|NCT03092674|Drug|Decitabine|Given IV
15972688|NCT03092674|Other|Laboratory Biomarker Analysis|Correlative studies
15972689|NCT03092674|Drug|Midostaurin|Given PO
15972690|NCT03092674|Biological|Nivolumab|Given IV
15972691|NCT03092648|Biological|Bronchial basal cell|autologous bronchial basal cell transplantation
15972692|NCT03092635|Drug|OPC|OPC is a derivative of grape seed extract
15972693|NCT03092622|Other|Exercise|Exercise training intervention as described earlier.
15972694|NCT03092609|Behavioral|Attention Bias Modification|Attention bias modification (ABM) sessions will consist of a modified dot-probe task that only contains incongruent trials (i.e., target-dot - neutral stimulus 100% pairing).
15972695|NCT03092609|Behavioral|Attention Control|Attention control (AC) sessions, will consist of a standard dot-probe task (i.e., target-dot - neutral/threat stimulus 50% pairing). Thus, for AC participants, bias should remain the same, while ABM participants should show a reduced bias to threat.
15972696|NCT03092596|Behavioral|Patient-administered screening tool|screener for drug and alcohol misuse - NIDA Quick Screen combined with AUDIT and DAST
15972697|NCT03092596|Behavioral|Patient health navigator-administered screening tool|patient health navigator-administered screener
15972698|NCT03092596|Behavioral|Patient health navigator-assisted linkage to treatment|patient health navigator-assisted linkage to substance abuse treatment
15972699|NCT03092583|Other|Blood sample|35 mL, 7 tubes
15972700|NCT03092570|Device|With stimulation|ramp stimulation from 0 to 2 mA followed by 20 minutes of stimulation at 2mA while practicing during 3 of the 4 sessions
15972701|NCT03092570|Device|No stimulation|ramp stimulation from 0 to 2 mA followed by 30 sec of stimulation at 2mA.
15972702|NCT03092557|Other|Determination of local pleural strain|For each tidal volume, the local pleural strain will be determined over three consecutive respiratory cycles at four predetermined sites using lung ultrasonography.
15972703|NCT03092544|Drug|dimethyl fumarate|Active drug
15972704|NCT03092531|Behavioral|Positive STEPS|Step 1: 2 way SMS text messages; Step 2: Five in-person, counseling sessions. Each counseling session will last approximately 50 minutes.
15972709|NCT03092479|Behavioral|Behavioral Intervention|Eight bi-weekly small group sessions of approximately 10 participants with session content focused on addressing psychosocial changes after surgery, strategies for postoperative diet and adherence and preventing weight regain.
15972710|NCT03092466|Procedure|femoral nerve catheter|femoral block with Ropivacaine 0.75% (15 ml) in femoral catheter
15972711|NCT03092466|Drug|femoral group|femoral block with Ropivacaine 0.75% (15 ml) in femoral catheter
15972712|NCT03092466|Drug|control group|infusion of saline solution (15ml) in femoral catheter
15972713|NCT03092453|Biological|Mature dendritic cell (DC) vaccine|Mature DC 7.5-15 million/peptide followed by 2 booster every six weeks of 1-5 million/peptide followed by standard of care anti PD-1 therapy.
15972714|NCT03092453|Drug|Cyclophosphamide 300mg/m^2|administered prior to subject's first DC dose
15972715|NCT03092453|Drug|Pembrolizumab|administered 7-8 weeks after subject's last DC dose
15972716|NCT03092440|Other|serious game|"During three hours, each learner will play with the three different cases of the LabForGames Warning serious game."
15972717|NCT03092427|Dietary Supplement|VSL#3|Dietary Supplement
15972718|NCT03092427|Other|Placebo|Placebo
15972719|NCT03092414|Procedure|WLE and then LCI|The gastric mucosa was evaluated with WLE and then LCI by two different endoscopists.
15972720|NCT03092414|Procedure|LCI and then WLE|The gastric mucosa was evaluated with LCI and then WLE by two different endoscopists.
15972799|NCT03091816|Device|Computed Tomography Perfusion Imaging|Undergo DPCT
15972721|NCT03092388|Diagnostic Test|Multi Frequency Bioimpedance Analysis (mfBIA)|Multi Frequency Bioimpedance Analysis (mfBIA) uses very small electric current at different frequencies (5, 50, 100 kHz) to measure the resistance and reactance of the entire body and different segmental body compartiments. With a special software total body fluid can be calculated. By analyzing raw data at different frequencies a detailed view on body and segments fluid distribution is possible.
15972722|NCT03092388|Diagnostic Test|Polysomnography/Polygraphy (PSG/PG)|Sleep is digital recorded by using PSG/PG in hospital and manually analyzed by physicians according to current AASM guidelines.
15972723|NCT03092388|Diagnostic Test|Capillary Blood Gas Analysis (CBGA)|CBGA is a less invasive method to gain arterial blood like gas samples without the punctation of an artery. After inducing a good capillary perfusion, capillary blood is taken by a small punctation of the tip of one ear. The sample is automatically analysed in a blood gas analyzer.
15972724|NCT03092388|Diagnostic Test|Tilting Table with Hemodynamic Monitoring|A tilting table offers the opportunity to turn a study subject automatically from vertical into horizontal position and back. By using non-invasive monitoring technique, hemodynamic parameters are recorded permanently.
15972725|NCT03092375|Drug|Glecaprevir/Pibrentasvir (G/P) 300mg/120mg|daily
15972726|NCT03092375|Drug|Ribavirin 200Mg Tablet|Weight-based 1000-1200 mg
15972727|NCT03092349|Device|Vector optimisation|Evaluation of hemodynamically best LV Stimulation vector and device programming according to measurements
15972728|NCT03092336|Other|Electrical Stimulation|electrical stimulation training
15972729|NCT03092336|Other|Strength training|strength training group
15972730|NCT03092323|Drug|Pembrolizumab|Pembrolizumab will be administered at 200 mg intravenously every 3 weeks for patients on the treatment arm.
15972731|NCT03092310|Device|Artificial Pancreas Device|Artificial Pancreas Device
15972732|NCT03092284|Biological|Cardiology Stem Cell Centre Adipose Stem Cell (CSCC_ASC)|Direct intramyocardial injection of CSCC_ASC
15972733|NCT03092284|Biological|Placebo|Saline
15972734|NCT03092271|Behavioral|Stepped Care for Suicide Prevention|ZSQI plus Stepped Care for Suicide Prevention
15972735|NCT03092271|Behavioral|Zero Suicide Quality Improvement|ZSQI
15972736|NCT03092258|Other|Questionnaire|Questionnaire to be completed by staff
15972737|NCT03092245|Drug|OctaplasLG|OctaplasLG is given as an infusion when resuscitation fluids are required.
15972738|NCT03092245|Drug|Ringer-Acetate|Ringer-acetate is given as an infusion when resuscitation fluids are required.
15972739|NCT03092232|Drug|PF-06865571|Single ascending dose of PF-06865571 as extemporaneously prepared solution/suspension, once every 2 week in a cross over study: 5 mg, 50 mg, 500 mg, TBD (to be determined)/2000 mg.
15972740|NCT03092232|Drug|PF-06865571|Single ascending dose of PF-06865571 as extemporaneously prepared solution/suspension, once every 2 week in a cross over study: 15 mg, 150 mg, 1000 mg, TBD/2000 mg.
15972741|NCT03092232|Drug|PF-06865571|Single repeated (TBD mg) dose as extemporaneously prepared solution/suspension of PF-06865571.
15972742|NCT03092232|Drug|Placebo|Matching Placebo for PF-06865571 for each cohort.
15972743|NCT03092219|Device|TEOSYAL RHA Redensity|A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of streptococcus zooepidemicus, formulated to a concentration of 15 mg/g and 0.3% w/w lidocaine in a physiologic buffer.
15972744|NCT03092206|Drug|F/TAF|antiretroviral therapy
15972745|NCT03092206|Drug|E/C/F/TAF|antiretroviral therapy
15972746|NCT03092206|Drug|R/F/TAF|antiretroviral therapy
15972747|NCT03092193|Drug|Naproxen|20 phenotyped for CYP2C9 and CYP2C19 (by PCR) and for the pharmacokinetics of naproxen, saliva samples will be collected of these patients at different times after ingestion of a tablet of naproxen (500mg) (before, 0,25; 0,5; 0,75; 1; 1,5; 2; 3; 4; 5; 6; 8; 11; 24; 48; 72 e 96 hours after ingestion).
15972748|NCT03092193|Drug|Naproxen-esomeprazole|20 phenotyped for CYP2C9 and CYP2C19 (by PCR) and for the pharmacokinetics of naproxen-esomeprazole, saliva samples will be collected of these patients at different times after ingestion of a tablet of naproxen-esomeprazole (500mg+20mg) (after one month of the first collection) (before, 0,25; 0,5; 0,75; 1; 1,5; 2; 3; 4; 5; 6; 8; 11; 24; 48; 72 e 96 hours after ingestion).
15972749|NCT03092180|Drug|Intravenous Infusion|Intravenous infusion of follow medicine at disease onset: methyprednisolone and/or human intravenous immunoglobulin
15972750|NCT03092167|Other|Physical exercises|Physical exercises
15972751|NCT03092154|Drug|Lipid-lowering agents (Artovastatin)|Artovastatin 20 mg /day, orally, 12 consecutive weeks.
15972752|NCT03092141|Other|Physical training|
15972753|NCT03092115|Device|HIV medication adherence app|A medication adherence mobile application for HIV+ youth. It is a theory-driven, patient-centered, mobile phone-based intervention targeting medication adherence and engagement in care among HIV+ youth with features including, but not limited to: custom avatar, medication reminders, calendar tracking of medication adherence, and anonymous chat function for social support.
15972754|NCT03092102|Drug|HEC585|HEC585, a pyrimidone compound, is structurally related to pirfenidone, a pyridine compound.
15972755|NCT03092089|Drug|Definity, (Lipid Microspheres) Intravenous Suspension|Sonothrombolysis (High Impulse therapeutic ultrasound with infusion of ultrasound contrast agent Definity) will be applied before and after standard of care reperfusion therapy with PPCI
15972756|NCT03092089|Device|Myocardial Contrast Echocardiography|Myocardial contrast echocardiography will be applied before standard of care reperfusion therapy as well as prior to discharge and at 3 month follow up
15972757|NCT03092089|Procedure|Repurfusion therapy with PPCI|Patients will receive reperfusion therapy with PPCI as standard of care
15972758|NCT03092076|Drug|Ticagrelor|180 mg loading dose
15972759|NCT03092063|Behavioral|Tomando Control-Nurse|Tomando Control de su Diabetes-Nurse is a community-based intervention given in six 2.5 hour sessions. The Spanish-language sessions are led by two trained Registered Nurses. Subjects covered in these sessions include: 1) techniques to deal with the symptoms of diabetes and associated conditions; 2) appropriate exercise; 3) healthy eating; 4) correct use of diabetes medications; and 5) working more effectively with health care providers in a collaborative partnership. Participants make weekly action plans, share experiences, and help each other solve problems they encounter in creating and carrying out their self-management strategies.
15972800|NCT03091816|Other|Laboratory Biomarker Analysis|Correlative studies
15972760|NCT03092063|Behavioral|Tomando Control-Promotora|Tomando Control de su Diabetes-Promotora is a community-based intervention given in six 2.5 hour sessions. The Spanish-language sessions are led by two trained promotoras. Subjects covered in these sessions include: 1) techniques to deal with the symptoms of diabetes and associated conditions; 2) appropriate exercise; 3) healthy eating; 4) correct use of diabetes medications; and 5) working more effectively with health care providers in a collaborative partnership. Participants make weekly action plans, share experiences, and help each other solve problems they encounter in creating and carrying out their self-management strategies.
15972761|NCT03092063|Behavioral|Enhanced engagement|The Tomando Control clinician (either a promotora or a Registered Nurse, depending on the original group assignment), will conduct up to three home visits that are designed to explain the purpose of the TC intervention to a key relative so as to re-engage the family member in the group process
15972762|NCT03092063|Behavioral|Multifamily Group|"The multifamily group consists of three components: three initial joining sessions conducted with each of the families separately; a one-day (six hour) educational workshop; and ongoing multifamily group sessions."
15972763|NCT03092050|Behavioral|Guided Imagery and Mindfulness|This is a behavioral intervention using guided imagery and mindfulness techniques.
15972764|NCT03092050|Behavioral|Facilitated Discussion|This is a behavioral intervention that involves discussion and group support.
15972765|NCT03092037|Procedure|Blood draw|The Investigators will collect serum and whole blood from participants.
15972766|NCT03092024|Other|SPIN-HAND program|The internet-based SPIN-HAND program consists of 4 modules (1) Thumb Flexibility and Strength (3 exercises); (2) Finger Bending (3 exercises); (3) Finger Extension (3 exercises); and (4) Wrist Flexibility and Strength (2 exercises). The program includes sections on developing a personalized program, goal-setting strategies and examples, progress tracking, sharing goals and progress with friends and family, and patient stories of experiences with hand disability and hand exercises. Instructional videos demonstrate and explain how to perform each exercise properly with pictures to illustrate common mistakes. Separate versions of each exercise are available for patients with mild/moderate and more severe hand involvement.
15972767|NCT03092011|Drug|Clonidine|Clonidine at 0.38 mcg/kg/dose every 3 hours or 0.5 mcg/kg/dose every 4 hours Clonidine dose will be increased by 25% of the previous dose if needed. It will be decreased by 10% of the highest dose using the original/birth weight (same amount each time) every 24 to 48 hours, provided the scores remain below 8.
15972768|NCT03092011|Drug|Morphine Sulfate|Morphine at 0.03 mg/kg/dose every 3 hours or 0.04 mg/kg/dose every 4 hours Morphine dose will be increased by 25% of the previous dose if needed. It will be decreased by 10% of the highest dose using the original/birth weight (same amount each time) every 24 to 48 hours, provided the scores remain below 8.
15972769|NCT03091998|Drug|CD-NP|Participants will receive a subcutaneous injection of CD-NP (5 mcg / kg) daily for 3 days
15972770|NCT03091998|Other|Placebo|Participants will receive an ~ 1mL subcutaneous injection of normal saline, in lieu of Study Drug, for 3 days
15972771|NCT03091985|Device|PersonalFit - Breast shield|Subjects are to pump 15 min with the comparator device
15972772|NCT03091985|Device|Brownie - Breast shield|Subjects are to pump 15 min with the investigational device
15972773|NCT03091972|Procedure|Pulmonary vein isolation|A pulmonary vein isolation procedure will be performed using radiofrequency ablation with contact force monitoring.
15972774|NCT03091972|Procedure|Contact force assisted left atrial linear ablation|Left atrial linear ablation (Roof line and Anterior line) after pulmonary vein isolation during catheter ablation for persistent atrial fibrillation monitoring contact force.
15972775|NCT03091972|Procedure|left atrial linear ablation without contact force monitoring|Left atrial linear ablation (Roof line and Anterior line) after pulmonary vein isolation during catheter ablation for persistent atrial fibrillation without monitoring contact force.
15972776|NCT03091946|Other|Overnight oats with additional dried fruits, nuts and seeds|Oatmeal
15972777|NCT03091946|Other|Cooked cream of rice with additional dried fruits, nuts and seeds|Cooked cream of rice
15972778|NCT03091933|Biological|GLIDE|Gudide Lymphocyte by Immunopeptide Derived Expansion (GLIDE) is an anti- Minor histocompatibility (MiHA) cell line
15972779|NCT03091920|Drug|IW-1973|Oral Tablet
15972780|NCT03091920|Drug|Placebo|Oral Tablet
15972781|NCT03091894|Drug|Propofol|propofol intravenous infusion via syringe pump with loading dose of 0.5 mg/kg over 3 minutes then continuous infusion in a dose of 25-75 ug/kg/minute
15972782|NCT03091894|Drug|Dexmedetomidine|dexmedetomidine intravenous infusion via syringe pump with loading dose of 0.5ug/kg over 5 minutes the continuous infusion in a dose of 0.2-0.7ug/kg/hour in addition to the propofol infusion as in propofol group
15972783|NCT03091881|Drug|Granisetron 0.1 MG/ML|Granisetron 0.1 MG/ML Will be given 10 min before spinal block
15972784|NCT03091881|Drug|Placebos|Placebos will be given 10 min before spinal block
15972785|NCT03091868|Drug|Placebo oral capsule|Matching placebo capsules. Oral administration.
15972786|NCT03091868|Drug|Sinemet® 100/25|Single-dose of immediate release levodopa/carbidopa 100/25 mg consisted of 1 tablet of Sinemet® 100/25. Route of administration: Oral.
15972787|NCT03091868|Drug|Comtan®|Single-dose of entacapone 200 mg consisted of 1 tablet of Comtan®. Route of administration: Oral.
15972788|NCT03091868|Drug|BIA 6-512 25 mg|BIA 6-512 capsules strengths 25 mg. Oral administration.
15972789|NCT03091868|Drug|BIA 6-512 100 mg|BIA 6-512 capsules strengths 100 mg. Oral administration.
15972790|NCT03091855|Other|Questionnaire|Alzheimer's Disease Assessment Scale (ADAS-cog11) and Disability Assessment for Dementia (DAD) Questionnaires
15972791|NCT03091855|Diagnostic Test|Magnetic Resonance Imaging|MRI at baseline and at 24 months post-enrollment for 20 sub-study participants
15972792|NCT03091842|Behavioral|Exercise Intervention|Undergo supervised CARE program
15972793|NCT03091842|Behavioral|Exercise Intervention|Undergo supervised TARE program
15972794|NCT03091842|Behavioral|Exercise Intervention|Undergo home-based stretching program
15972795|NCT03091842|Other|Informational Intervention|Receive instructional DVD and booklet of the flexibility exercises
15972796|NCT03091842|Other|Laboratory Biomarker Analysis|Correlative studies
15972797|NCT03091842|Other|Quality-of-Life Assessment|Ancillary studies
15972798|NCT03091842|Other|Questionnaire Administration|Ancillary studies
15972801|NCT03091816|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
15972802|NCT03091803|Device|Dynamic Contrast-Enhanced Magnetic Resonance Imaging|Undergo GOCART DCE MRI
15972803|NCT03091803|Drug|Gadobenate Dimeglumine|Given IV
15972804|NCT03091803|Drug|Gadoterate Meglumine|Given IV
15972805|NCT03091803|Device|Magnetic Resonance Imaging|Undergo QSM and T1WI imaging
15972806|NCT03091790|Device|Synthetic Mesh|Synthetic mesh used during open ventral hernia repair
15972807|NCT03091790|Device|Biologic Mesh|Biologic mesh used during open ventral hernia repair
15972808|NCT03091777|Drug|GDC-229|GDC-229 is a vaginal gel.
15972809|NCT03091777|Drug|Metronidazole Vaginal Gel 0.75%|Metronidazole Vaginal Gel 0.75% is an FDA-approved drug
15972810|NCT03091777|Drug|Placebo|Inactive arm of the study
15972811|NCT03091751|Drug|BeneFIX|BeneFIX is a recombinant FIX that contains nonacog alfa, reconstituted in solvent and administered as a single dose of 65-75 IU/kg.
15972812|NCT03091738|Drug|Ramelteon Pill|Patients with compensated cirrhosis and insomnia will be provided ramelteon
15972813|NCT03091725|Procedure|Roux-en-Y gastric bypass surgery|A bariatric surgery procedure which will help individuals achieve 16-18% weight loss
15972814|NCT03091725|Behavioral|Very low-calorie diet|Subjects will meet with a dietitian and/or behaviorist over 4-6 months to lose 16-18% of their body weight.
15972815|NCT03091712|Device|Glooko Mobile Insulin Dosing System(MIDS)|Mobile Insulin Dosing System (MIDS) for all long acting insulin degludec titration management
15972816|NCT03091699|Drug|Nicotine|Participants will be required to smoke a cigarette to completion in a 20 minute time frame.
15972817|NCT03091699|Behavioral|Moderate Intensity Exercise|Participants will be required to perform 20 minutes of acute moderate intensity exercise (brisk walk) on a treadmill.
15972818|NCT03091686|Behavioral|HAPA SB Intervention Slideshow|In the experimental condition, participants will receive sedentary behaviour and diabetes information in the form of a slide show that will be viewed online. The intervention aims to address all components of the Health Action Process Approach. For the experimental group, the intervention material will target risk perceptions (RP) related to sitting by presenting evidence supported by research on sedentary behaviour and diabetes risk; outcome expectancies (OE) by presenting research on the effectiveness of breaking up sedentary time for improving blood sugar and insulin levels; and self-efficacy (SE) by providing strategies on how to reduce and break up sitting time.
15972819|NCT03091686|Behavioral|HAPA MVPA Attention-Control Slideshow|In the attention-control, participants will receive information in the form of a slide show that will be viewed online. The intervention aims to address all components of the Health Action Process Approach. The attention-control slide show will take the same approach as the Experimental group slideshow but the slides will be geared towards meeting moderate-vigorous physical activity guidelines.
15972820|NCT03091673|Drug|Glucagon|0.5 or 1.0 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector
15972821|NCT03091660|Biological|BCG Solution|Given intravesically
15972822|NCT03091660|Biological|BCG Tokyo-172 Strain Solution|Given intravesically
15972823|NCT03091660|Biological|BCG Tokyo-172 Strain Vaccine|Given ID
15972824|NCT03091660|Other|Laboratory Biomarker Analysis|Correlative studies
15972825|NCT03091647|Behavioral|acupressure intervention|Women in the acupressure intervention group will learn how to press three chief energy acupoints on each side of the body through an 11-minute Chinese-language video and press three acupoints (1 minute per acupoint) on both sides of the body every day for a total of 6 minutes per day for an 8-week intervention period and record their practice on daily logs. Women will be asked to return the logs every week by email or self-addressed envelopes.
15972826|NCT03091647|Behavioral|usual care|Women in the usual care group will receive primary and oncology care from their doctors as usual, and complete daily logs recording their fatigue and daily functioning levels. They also need to return the logs every week by email or self-addressed envelopes.
15972827|NCT03091634|Drug|xue-fu-zhu-yu capsule|participants are given to 6 xue-fu-zhu-yu capsule per time, twice a day. The duration is 7 weeks
15972828|NCT03091634|Drug|xue-fu-zhu-yu capsule simulated agent|participants are given to 6 xue-fu-zhu-yu capsule simulated agent per time, twice a day. The duration is 7 weeks
15972829|NCT03091595|Drug|15 mg E4/3 mg DRSP|15 mg E4/3 mg DRSP combined tablets will be administered orally once daily in a 24/4 day regimen for three consecutive cycles
15972830|NCT03091595|Drug|20 mcg EE/3 mg DRSP|20 mcg EE/3 mg DRSP combined tablets will be administered orally once daily in a 24/4 day regimen for three consecutive cycles
15972831|NCT03091582|Behavioral|Cognitive factors|The Cognitive-Behavioral Therapy (CBT) intervention will focus on catastrophizing and rumination. CBT emphasizes the role of cognitive and behavioral factors on affective distress
15972832|NCT03091582|Behavioral|Behavioral factors|The Cognitive-Behavioral Therapy (CBT) intervention will focus on catastrophizing and rumination. Behavioral factors on affective distress.
15972833|NCT03091582|Behavioral|Increase engagement of pleasant events|Behavioral Activation is grounded in learning theory and posits that lack of positive/active engagement of the person with his/her environment contributes to an increase in avoidant or passive behaviors and decreased reinforcement. An empirically validated treatment, behavioral activation reduces depressive symptoms and increase engagement of pleasant events.
15972834|NCT03091569|Other|Vitamin K Cream|To be applied topically 3 times in 24 hours (approximately at 8 and 16 hours post initial application) from the appearance of the erythema.
15972835|NCT03091569|Other|Placebo Cream|To be applied topically 3 times in 24 hours (approximately at 8 and 16 hours post initial application) from the appearance of the erythema.
15972836|NCT03091543|Drug|Madopar® HBS 125|1 capsule of Madopar® HBS 125 (levodopa 100 mg / benserazide 25 mg) in an open label manner, concomitantly with BIA 6-512/Placebo.
15972837|NCT03091543|Drug|Placebo|2 capsules of placebo
15972838|NCT03091543|Drug|BIA 6-512 25 mg dose|1 capsule of 25 mg plus 1 capsule of placebo
15972839|NCT03091543|Drug|BIA 6-512 50 mg dose|2 capsules of 25 mg
15972840|NCT03091543|Drug|BIA 6-512 100 mg dose|1 capsule of 100 mg plus 1 capsule of placebo
15972841|NCT03091543|Drug|BIA 6-512 200 mg dose|2 capsules of 100 mg
15972934|NCT03090672|Procedure|Tissue Stromal Vascular Fraction|tSVF
15972935|NCT03090672|Biological|Platelet Rich Plasma|PRP
15972936|NCT03090672|Procedure|Cellular Stromal Vascular Fraction|cSVF
15972842|NCT03091530|Other|Sleeper Stretch|The sleeper stretch protocol will follow the process described by Wilk with the subject lying on his throwing shoulder side, with the lateral border of the scapula on the table, and the glenohumeral and elbow joints both at 90 degrees of flexion. Participants will be instructed to passively internally rotate the shoulder with gentle overpressure applied on the dorsum of the dominant arm wrist by the nondominant hand to the point of stretch on the posterior aspect of the shoulder. Stretches will be held for 20 seconds each and repeated 4 times for optimal sustained collagen elongation. This protocol will be performed on days 0-4 after the throwing session.
15972843|NCT03091530|Other|90/90 Hip Lift with Balloon Blow Exercise|The 90/90 Hip Lift with Balloon Blow Exercise (BBE) will follow the guidelines described by the Postural Restoration Institute. The subjects will lie supine with hips and knees flexed to 90 degrees, the right arm flexed to end range and resting on the floor. Using the left arm to hold the balloon, subjects will inhale fully and exhale into a balloon while holding a posterior pelvic tilt. The subjects inhale and then exhale into the balloon fully, then hold their breath for 5 seconds while putting their tongue on the roof of their mouth.
15972844|NCT03091517|Behavioral|GlycoLeap|"GlycoLeap is a 24-week programme includes the following features:
~Interactive Education Lessons: Beginning week 1, the participant will be presented with a diabetes self-management education curriculum. These lessons are divided into 6 phases, and each lesson is fully accessible online from a computer or mobile phone, and takes approximately 10 - 15 minutes to complete.
~The Glyco Mobile Application: During the 24 week intervention period, the participant will use the Glyco mobile application that allows them to track their weight (measured on the wireless weighing scale), self-tested glucose readings (measured using the glucometer kit), and log their foods and meals by taking photos using their phone. A health coach will review the participant's data regularly, provide personalised feedback."
15972845|NCT03091504|Device|High flow nasal cannula|High flow nasal cannula is a soft and flexible nasal prongs with adjustable head strap fits over the patient's ears, it delivers a broad variety of gas flows directly into the nares without gas jetting.
15972846|NCT03091504|Drug|Albuterol Sulfate|Albuterol is a short acting inhaled bronchodilator
15972847|NCT03091491|Drug|Ipilimumab|Ipilimumab 1 mg/kg administered every 6 weeks as a 30 min IV infusion
15972848|NCT03091491|Drug|Nivolumab|Nivolumab 3 mg/kg administered every 2 weeks as a 30 min IV infusion
15972849|NCT03091478|Drug|Pembrolizumab|200mg every 3 weeks
15972850|NCT03091439|Drug|Dalbavancin|Participants received Dalbavancin 1500 mg, intravenous (IV) administration over 30 minutes on Day 1 and on Day 8.
15972851|NCT03091439|Drug|Standard of Care|Participants received an antibiotic consistent with standard of care (SOC) for osteomyelitis based on Investigator judgment. The duration of treatment was 4-6 weeks.
15972852|NCT03091426|Drug|Omiganan|Omiganan 1%
15972853|NCT03091426|Drug|Omiganan|Omiganan 1.75%
15972854|NCT03091426|Drug|Omiganan|Omiganan 2.5%
15972855|NCT03091426|Drug|Placebo|Vehicle
15972856|NCT03091413|Diagnostic Test|diaphragm ultrasound|"For each patient intubated and ventilated in our ICU we will performed diaphragm ultrasound during the weaning process.
~We will performed the measurement of diaphragmatic maximum excursion during a maximal inspiration using an abdominal standard preset with M-mode, with the so called anatomical M-mode.
~We will put the probe in the right subcostal window to use the hepatic window to assess the movement of the diaphragm. We will performed the measure of the diaphragm excursion with patient in semi-recumbent position and through a transhepatic transverse oblique scan while the patient is on mechanical ventilation and undergo a Pimax maneuver, that consists in a temporary occlusion of the airway with an expiratory pause.
~We will performed the measure three times, and we will take into account the best one made by the patient."
15972857|NCT03091400|Drug|Atomoxetine|Atomoxetine (40 mg qd titration dose for first seven days, followed by 80 mg qd target dose for remaining five weeks)
15972858|NCT03091400|Drug|Placebo|Identically encapsulated placebo, with dose matched to experimental agent (40 mg qd titration dose for first seven days, followed by 80 mg qd target dose for remaining five weeks)
15972859|NCT03091387|Diagnostic Test|Spontaneous Breathing Test|subjects when ready for extubation will be given a three minute spontaneous breathing test on ET-Cpap mode of the ventilator
15972860|NCT03091374|Drug|Somatotropin (Human)|
15972861|NCT03091361|Other|imaging, no intervention|no intervention
15972862|NCT03091348|Drug|Testosterone|Testosterone cypionate injection
15972863|NCT03091335|Other|Music-listening|Patients listen to music on headphones
15972864|NCT03091322|Device|Pacemaker of the Edora Family (Edora/ Evity/ Enitra/ Enticos) 8|Assessment of the AV Opt and LV VectorOpt features
15972865|NCT03091309|Other|Interactive educational video|A web-link to an educational video on IBD and pregnancy tailored to emphasize the importance of optimal disease control and medication adherence.
15972866|NCT03091309|Behavioral|Initial in-person counseling with an IBD nurse|This session will emphasize key points from the educational video and the nurse will answer any additional questions the subject may have. The nurse will assess subjects' medication adherence and specifically query any concerns subjects may have regarding specific medications and discuss their intentions to be adherent throughout pregnancy.
15972867|NCT03091309|Behavioral|Motivational interviewing|The nurse will be trained in a technique known as motivational interviewing (MI) specifically adapted for optimizing medication adherence during pregnancy.
15972868|NCT03091309|Behavioral|Telemedicine-based follow-up|The IBD nurse will arrange follow-up visits with each subject on a monthly basis with additional ad-hoc sessions as needed. The encounter will focus on monitoring disease activity adherence and applying MI communication skills to reinforce and improve the latter.
15972869|NCT03091309|Other|Monthly follow-up questionnaires|Web-based short questionnaires, administered monthly, will be used to assess medication adherence [self-reported using the 5 item Medication Adherence Report Scale (MARS-5)] and IBD related disease activated [self-reported using PRO-2 scale for Crohn's Disease related disease activity and 6-Point Mayo Score for Ulcerative Colitis related disease activity].
15972937|NCT03090659|Biological|LCAR-B38M CAR-T cell injection|
15972938|NCT03090646|Other|Financial Incentive|Up to three gift cards to a major online retailer.
15972939|NCT03090633|Device|Fetoscopy|Minimally invasive in-utero surgery
15972940|NCT03090620|Drug|Physostigmine|Administration of physostigmine bolus followed by an infusion
15972941|NCT03090620|Drug|Lorazepam|Administration of lorazepam bolus followed by normal saline infusion
15972870|NCT03091309|Other|Comprehensive questionnaires|Web-based detailed questionnaires, administered at enrolment and gestational week 34, will be used to assess medication adherence [self-reported using the Medication Adherence Report Scale (MARS-5)], patient trust in physician [self-reported using the Trust in Physician Scale (TIPS)], IBD related disease activated [self-reported using the PRO-2 or 6-Point Mayo Score], IBD-specific health related quality of life [self-reported using the Inflammatory Bowel Disease Questionnaire (IBDQ)], patient satisfaction [self-reported using the Patient Satisfaction with Healthcare in Inflammatory Bowel Disease (CACHE) questionnaire]and IBD specific knowledge [self-reported using the Crohn's and Colitis Knowledge (CCKNOW) questionnaire].
15972871|NCT03091257|Drug|Dabrafenib|Administered Orally BID
15972872|NCT03091257|Drug|Trametinib|Administered Orally once daily
15972873|NCT03091231|Diagnostic Test|mpUS multiparametric Ultrasound|compare the mpUS to other methods
15972874|NCT03091192|Drug|Savolitinib|600 mg (400 mg if <50 kg) by mouth (PO) with a meal once daily (QD), continuously
15972875|NCT03091192|Drug|Sunitinib|50 mg by mouth (PO) once daily (QD), with or w/o food, 4 weeks on/2weeks off
15972876|NCT03091179|Device|THRIVE|active nasal oxygen delivery system
15972877|NCT03091179|Device|Endotracheal tube|a plastic tube for mechanical ventilation
15972878|NCT03091166|Drug|Dexmedetomidine|
15972879|NCT03091153|Other|Medication Review|In depth medication review with a focus on deprescribing
15972880|NCT03091101|Device|Scleral lens wearing keratoconics|Cohort of keratoconics fitted with scleral lenses and monitored over 6 months
15972881|NCT03091088|Other|walking at an intense pace|Participants walk 6 kilometers in 1 hour at least 3 times per week
15972882|NCT03091088|Other|osteoporosis specific-oriented training|1 hour of physical activity, 2 times per week, based on the Asociación Española con la Osteoporosis y la Artrosis (AECOS) recommendations. Sessions are divided in 15 minutes of warmup (8 to 10, 60-second exercises), 30-35 minutes of combined exercises with loads and weights, as well as high intensity exercises, and 10-15 minutes of cooldown activities (based on Frederick relaxation techniques)
15972883|NCT03091075|Drug|Oxandrolone Pill|Treatment group will receive 24 mg Oxandrolone per day if male and 12 mg Oxandrolone per day if female, with dosing starting at time of surgery and continuing 12 weeks postoperative
15972884|NCT03091075|Drug|Placebo Oral Tablet|Placebo group will receive a placebo oral tablet, beginning at the time of surgery and continuing 12 weeks postoperative
15972885|NCT03091062|Device|Vest® Airway Clearance System|High frequency chest wall oscillation (HFCWO) therapy is commonly prescribed to provide routine airway clearance in patients with a need for regular airway clearance therapy. HFCWO generates high velocity expiratory airflow that is thought to mobilize secretions by the sheer force created.
15972886|NCT03091062|Device|Monarch™ System|Generates airflow at frequencies similar to those provided by HFCWO and also provides direct percussive therapy.
15972887|NCT03091036|Other|Proactive healthcare intervention|There is an intervention in the coordination of health resources, and monitoring readmissions and know the benefit in total cost of care in 4 month.
15972888|NCT03091023|Procedure|Endometrial Biopsy and endometrial fluid collection|
15972889|NCT03091010|Other|Fecal Microbiota Transplantation|Fecal Microbiota Transplantation will be given 100mL of suspension. It will given for a period of 7 days
15972890|NCT03091010|Drug|Steroids|Oral steroids 40 mg (prednisolone) will be given for a period of 7 days in hospital followed by 3 weeks on OPD basis
15972891|NCT03090997|Dietary Supplement|vitamin C (500 mg / day) + placebo|Adminstration of vitamin C (500 mg / day/orally) + placebo (same presentation like resveratrol)
15972892|NCT03090997|Dietary Supplement|resveratrol (500 mg / day) + placebo|Adminstration of resveratrol (500 mg / day/orally) + placebo (same presentation like vitamin C)
15972893|NCT03090997|Dietary Supplement|vitamin C (500 mg / day) and resveratrol (500 mg / day)|Adminstration of resveratrol (500 mg / day/orally) + vitamin C 500 mg/day/orally)
15972894|NCT03090984|Device|PMMA (BKU)|At serial time points before, during and after each study hemodialysis session using a BKU dialyzer, blood samples will be drawn for coagulation activation analyses.
15972895|NCT03090984|Device|PS (Phylter)|At serial time points before, during and after each study hemodialysis session using a Phylter dialyzer, blood samples will be drawn for coagulation activation
15972896|NCT03090984|Device|AN69ST (Evodial)|At serial time points before, during and after each study hemodialysis session using an Evodial dialyzer, blood samples will be drawn for coagulation activation
15972897|NCT03090971|Drug|Diclofenac Sodium|Following microporation, treatment neurofibromas will receive treatment with topical diclofenac
15972898|NCT03090971|Drug|Saline Solution|Following microporation, control neurofibromas will receive treatment with topical saline
15972899|NCT03090958|Behavioral|AllyQuest|AllyQuest is a novel, high impact secondary prevention intervention delivered via mobile phones to improve linkage and engagement in care among newly diagnosed HIV+ YMSM. The development of this intervention is both timely and vital given the urgency of the ongoing HIV epidemic among YMSM. The features of the intervention aim to target previously identified barriers to care among newly diagnosed youth, namely, low HIV health literacy, lack of social support, and internalized stigma related to their diagnosis.
15972900|NCT03090945|Other|This is an obsevational cohort study|no intervention
15972901|NCT03090932|Other|Blood draw|Research subjects will have two tubes of blood drawn, approximately 20mL.
15972902|NCT03090919|Biological|Platelet transfusion|
15972903|NCT03090919|Other|Saline|
15972904|NCT03090906|Procedure|Soft tissue augmentation palate|"Recipient site: Intrasulcular incision at the buccal side of the implant extending in one adjacent tooth for each side and a partial-thickness mucosal ﬂap raised. The connective tissue was secured with suture. Allocation to either treatment was performed according to a randomization table.
~Donor site A double-bladed scalpel handle 1,5mm was used in both areas to obtain the same thickness.
~Palate (CG) The double incision was made approximately 2 to 3 mm apical to the gingival margins of premolars. The donor tissue was removed and cross-mattress sutures were used to approximate the wound on the palate.
~In both groups the epithelial collar removed. Graft required dimensions for both groups:10mm height, 12mm length and 1,5mm thick."
15972942|NCT03090607|Device|Aluvra™|Endoscopic injection of bulking agent to the lower esophageal sphincter
15972943|NCT03090607|Drug|Saline|Endoscopic injection of saline
15973548|NCT03085940|Drug|Hydroxychloroquine|Hydroxychloroquine 400mg once daily initially
15972905|NCT03090906|Procedure|Soft tissue augmentation tuberosity|"Recipient site: Intrasulcular incision at the buccal side of the implant extending in one adjacent tooth for each side and a partial-thickness mucosal ﬂap raised. The connective tissue was secured with suture. Allocation to either treatment was performed according to a randomization table.
~Donor site A double-bladed scalpel handle 1,5mm was used in both areas to obtain the same thickness.
~Tuberosity (TG) The double incision was made from the distal of the terminal tooth. A second incision was made perpendicular to the linear incision at a distal point, which joined the two linear incisions. The graft was removed and a crossed horizontal suspension suture was used.
~Epithelial collar removed. Graft required dimensions for both groups:10mm height, 12mm length and 1,5mm thick."
15972906|NCT03090906|Device|Intraoral optical scan|Intraoral optical scan was performed at both groups at baseline, 3 months, 4 months and 12 months to be able to compare volumetric changes.
15972907|NCT03090893|Drug|ATryn continuous infusion|replenish serum thrombin levels
15972908|NCT03090880|Drug|Tinzaparin Sodium|Subcutaneous tinzaparin 4,500 IU once daily for six months.
15972909|NCT03090867|Other|Relatives or surrogates are encouraged to perform care|"The relative or surrogate will perform at least two cares a week among feeding, mouth care, hair wash, shaving, eye care, hand, foot and face massage.
~All care are planned and perform under the supervision or/and in collaboration with a caregiver.
~The relative or surrogate will give his opinion by completing the study questionnaires."
15972910|NCT03090867|Other|Conventional ,care|The relative or surrogate will not be encouraged to perform care. The management of the relative or surrogate wi ll not changed from the regular standard of the ICU.
15972911|NCT03090854|Diagnostic Test|ADASCog|Neuropsychological test
15972912|NCT03090841|Biological|Bio-specimen collected|
15972913|NCT03090828|Behavioral|app-based therapeutic education|Patients will connect to a platform providing information on end-stage renal disease and to contact health care providers.
15972914|NCT03090828|Behavioral|enhanced app-based therapeutic education|Patients in the enhanced app group will also have access to a social network. (forum, chat room)
15972915|NCT03090815|Genetic|Sequencing of ctDNA in plasma|Sequencing of ctDNA in plasma
15972916|NCT03090802|Behavioral|Mentoring Adolescent Mothers at School (MAMAS)|Through the MAMAS program, 12 older mentor mothers, who themselves were pregnant adolescents, will mentor 240 younger adolescent mothers to provide ongoing psychosocial support, navigate re-admission to school, and facilitate access to an existing State-sponsored cash transfer, the child support grant (CSG), in the early postpartum period.
15972917|NCT03090776|Drug|Ketamine|low dose bolus and infusion ketamine, administered under general anesthesia
15972918|NCT03090776|Other|Placebo saline|bolus and infusion saline, administered under general anesthesia
15972919|NCT03090763|Genetic|PCR and sequencing|Blood will be subsequently added into a test tube containing RNA solution of a stabilizer, necessary for preservation of the circulating miRNAs. Subsequently, centrifugation will be performed in a cooled centrifuge and the material thus processed will be kept for the subsequent isolation. The isolation of miRNA will be performed using the High Pure miRNA Isolation Kit (Roche, Basel, CHE) according to the manufacturer's standardized procedure. Presence and quality of the miRNA isolated will be spectrophotometrically confirmed using the NanoDrop device (ThermoScientific, Wilmington, DE, USA). By means of the data available in the on-line gene data basis, primers that are necessary for amplification of miRNA through the RT-PCR method using fluorescent dyes will be suggested.
15972920|NCT03090750|Drug|Lavender Oil|Lavender essential oil applied to cotton ball (3 drops) and placed in a medicine cup on bedside table
15972921|NCT03090750|Drug|Bergamot Oil|Bergamot essential oil applied to cotton ball (3 drops) and placed in a medicine cup on bedside table
15972922|NCT03090750|Other|Water|Tap water applied to cotton ball (3 drops) and placed in a medicine cup on bedside table
15972923|NCT03090737|Biological|Nivolumab|Specified Dose on Specified Days
15972924|NCT03090724|Drug|BIA 5-453|100 mg of BIA 5-453 (combination of two 50 mg capsules); Oral, once-daily (QD), in the morning in fasting conditions
15972925|NCT03090711|Device|Transcranial Magnetic Stimulation (TMS)|The investigators recently showed that the repeated application of the so-called continuous theta burst protocol (cTBS) over the contralesional hemisphere resulted in a long-standing improvement of visual hemineglect (Cazzoli et al., 2012). The cTBS protocol was developed by Huang et al. (Huang et al., 2005) and modified by the investigators' group (Nyffeler et al., 2006). TBS protocol consists of a burst of 3 pulses at a frequency of 30 Hz, repeated at 6 Hz. One continuous train includes 801 pulses, the duration of one cTBS train is 44 seconds.
15972926|NCT03090711|Device|Transcranial Alternating Current Stimulation (tACS)|TACS stimulation involves two electrodes placed on either side of the desired site of cortical stimulation. The mode of stimulation used in this experiment is identical to previous studies using tACS in sleep ( Marshall et al., 2006; Prehn-Kristensen et al., 2014 ). Stimulation follows a sinusoidal pattern from 0 to 260 μA. This pattern is delivered at 0.75 Hz and is repeated for 225 cycles; a total of 5 minutes of stimulation. This 5 minute pattern is again repeated 5 times, with a minute of no stimulation between each; thus for a total of 30 minutes.
15972927|NCT03090711|Device|sham Transcranial Magnetic Stimulation (TMS)|Sham coil will be used to exclude possible nonspecific effects of the TMS. The sham coil is shielded i.e., the magnetic field output is weakened and therefore insufficiently powerful to stimulate the cortex.
15972928|NCT03090711|Device|sham Transcranial Alternating Current Stimulation (tACS)|Sham stimulation will be used to exclude possible nonspecific effects of the tACS. Sham tACS stimulation will involve actual stimulation for the first 30 seconds of the ramp-up period (stimulation power is gradually increased until its final level), and then immediately gradually decreased until zero (without the intermediate 4 minutes of actual stimulation). This procedure will be repeated 5 times every 6 minutes and shall induce similar cutaneous sensations as real stimulation.
15972929|NCT03090698|Drug|Hylan G-F 20|intra-articular administration
15972930|NCT03090698|Drug|Triamcinolone|Intra-articular administration
15972931|NCT03090685|Procedure|True auriculotherapy with seeds|Roasted edible mustard seeds with ~ 2mm diameter fixed with adhesive tape in 4 to 5 specific body points to control musculoskeletal pain.
15972932|NCT03090685|Procedure|Placebo Auriculotherapy with seeds|Roasted edible mustard seeds with ~ 2mm diameter fixed with adhesive tape at 4 points located in the auricular lobe not specific for musculoskeletal pain.
15972933|NCT03090672|Drug|Normal Saline|Normal Saline IV delivery
15973549|NCT03085940|Drug|Placebo|Placebo
15972944|NCT03090594|Procedure|Biopsy|Is to obtain pulmonary parenchyma samples using a flexible bronchoscope.
15972945|NCT03090581|Procedure|Biopsies CP|Transbronchial biopsies will be obtained with a flexible bronchoscope, using a cryoprobe.
15972946|NCT03090581|Procedure|Biopsies FC|Transbronchial biopsies will be obtained with a flexible bronchoscope, using a forceps.
15972947|NCT03090568|Drug|BIA 5-453|BIA 5-453 capsules 50 mg. Route of administration: Oral. In one period subjects received 4 capsules of 50 mg of BIA 5-453 after a fasting of at least 10 hours, and in the other period subjects were dosed with 4 capsules of 50 mg of BIA 5-453 after a standard high-fat and high-calorie meal
15972948|NCT03090555|Procedure|Translational manipulation|After the patient receives an interscalene block on the affected side, a physical therapist performs a series of thrust manipulations on the participant's affected shoulder. The participant's identified limitations of physiological and accessory motion revealed during manual examination guided the physical therapist's choice of technique, which primarily consisted of an accessory superior to inferior accessory gliding motion performed in a physiological position of limited motion. Additional gliding manipulations in combined movement positions such as increased flexion or abduction plus internal or external rotation were utilized until full passive physiologic motion was restored.
15972949|NCT03090555|Procedure|Manual therapy|The first clinic treatment session for all study participants included instruction in the home program of static stretching, resistive exercise, and ice, issue of an illustrated handout and digital video disc detailing the same program, and manual therapy (MT) by a physical therapist that included all indicated grades of non-thrust manipulation of the joints and soft tissue. The MT intervention was targeted toward any identifiable upper quarter pain or movement impairments. Subsequent clinic treatment sessions included additional MT, progression of the strengthening exercises, and reinforcement of the home program.
15972950|NCT03090542|Dietary Supplement|clinoptilolite|randomized, open-label, cross-over study of control vs clinoptilolite with a washout period separating the 2 phases
15972951|NCT03090529|Other|Exercise Group|The 12-week exercise-training program will include three sessions of aerobic exercise per week
15972952|NCT03090516|Drug|Ginkgo biloba dispersible tablets|Arm C：Ginkgo biloba dispersible tablets，0.15g at a time， three times a day.
15972953|NCT03090516|Drug|Donepezil|Arm A：Aricept 5mg/day
15972954|NCT03090516|Drug|Ginkgo biloba dispersible tablets and Donepezil|Arm B：Ginkgo biloba dispersible tablets，0.15g at a time， three times a day.Aricept 5mg/day.
15972955|NCT03090503|Drug|Aripiprazole|Initial dose: 10 mg.
15972956|NCT03090503|Drug|Risperidone|Initial dose: 2 mg.
15972957|NCT03090490|Other|Antipsychotic treatment discontinuation|Withdrawal of antipsychotic medication to stabilized patients
15972958|NCT03090490|Other|Maintenance treatment discontinuation|Maintenance antipsychotic medication to stabilized patients
15972959|NCT03090477|Behavioral|Pharmaceutical care and adherence aids|Medication review including drug-interaction check, individual patient counseling to improve understanding of treatment rationale and to elicit and address treatment-related concerns, provision of information booklets and adherence aids (calender blister packaging and smartphone medication reminder application), phone calls and face-to-face visits to follow-up on medication-related issues scheduled over a period of 6 months.
15972960|NCT03090464|Other|Use of digital disease management tool|The purpose of the study is to evaluate if the provision of a digital disease management tool, in addition to SOC for T2DM, will improve glycemic control. The impact of the tool will be assessed in comparison to a Control group who will receive SOC alone. All participants will complete the PRO assessments. This is a real world study carried out at the point of care.
15972961|NCT03090451|Behavioral|Aerobic Exercise|Aerobic physical exercise on treadmill, with intensity based on prior VO2-max testing during the screening visit.
15972962|NCT03090438|Procedure|Varicocele embolization|Ultrasound guided right internal jugular vein access with placement of a vascular sheath. Fluoroscopically guided selective catheterization of the left and right (if bilateral) spermatic veins to the level of the inguinal ligament. Occlusion of the spermatic vein(s) by embolization coils and a sclerosing agent (sodium tetradecyl sulphate 3%).
15972963|NCT03090412|Drug|HPPH|Given IV
15972964|NCT03090412|Other|Laboratory Biomarker Analysis|Correlative studies
15972965|NCT03090412|Drug|Photodynamic Therapy|Undergo PDT
15972966|NCT03090412|Other|Quality-of-Life Assessment|Ancillary studies
15972967|NCT03090412|Procedure|Therapeutic Conventional Surgery|Undergo standard of care surgery
15972968|NCT03090399|Device|FloTrac|For patients belonging to case group a Pulse Contour Analysis was adopted for optimize fluid administration
15972969|NCT03090386|Other|Cognitive Surveys|Complete the Cognitive Communication Survey, standardized cognitive and language assessments, and the Follow-up Cognitive Communication Survey after treatment
15972970|NCT03090373|Device|UroShield|The UroShield is an externally applied acoustic actuator which generates surface acoustic waves and transmits them along the length of the catheter. The device does not come in direct contact with the subjects.
15972971|NCT03090360|Dietary Supplement|Infant formula (CF)|Formula-fed infants will be randomly assigned to receive one of the study formulas (CF or EF) orally, ad libitum, each day from Study Day 1 until Study Day 180, for a treatment duration of approximately 180 days.
15972972|NCT03090360|Dietary Supplement|Infant Formula (EF)|Formula-fed infants will be randomly assigned to receive one of the study formulas (CF or EF) orally, ad libitum, each day from Study Day 1 until Study Day 180, for a treatment duration of approximately 180 days.
15972973|NCT03090347|Other|Overconsumption of specific dietary nutrient|Subjects will be studied before and then after the consumption of a diet where specific nutrients are provided in excess.
15972974|NCT03090334|Diagnostic Test|De-escalation|Antifungal therapy will be stopped according with BG results
15972975|NCT03090321|Behavioral|Stand Prompt|The participant will receive a notification asking them to stand or walk if they have been sitting for longer than 60 minutes
15972976|NCT03090321|Behavioral|Step Prompt|The participant will receive a notification if they are below 5000 steps by 3pm each day asking them to get to 10000 steps.
15972977|NCT03090321|Behavioral|Cluster Prompt|The participant will receive daily information notifications specific to the activity cluster they fall into based on the activity data collected in phase 1 of the study
15972978|NCT03090321|Behavioral|Read AHA website|Daily reminder to read the newsfeed from the American Heart Association (AHA) website, this is a control arm
15972979|NCT03090308|Other|Noninvasive positive pressure ventilation|All patients were ventilated using NIPPV (Engstrom Carestation), which was delivered to the patient through full-face mask and was started with pressure support of 8-12 cmH2O and PEEP of 3-5 cmH2O and gradually increased in 2 cmH2O steps. When patients tolerate FiO2 ≤ 0.5 with pressure support ≤ 8 cmH2O and PEEP ≤ 5 cmH2O for > 6 consecutive hours, withdrawal from NIPPV was attempted daily in 30 minutes spontaneous breathing trials.
15972980|NCT03090295|Device|Palpation and Accuro|Identify placement for spinal
15972981|NCT03090282|Procedure|mechanical treatment(mainly scaling and root planing), periodontal surgery(if indicated), implant placement.|The investigators shall follow the regular procedure to these patients.
15972982|NCT03090269|Drug|Methylphenidate Pill|3-month follow-up to study the effective dose as a treatment for cocaine dependence in toxicity and reduction in cocaine use
15972983|NCT03090256|Device|AcrySof® IQ PanOptix™ IOL|Multifocal intraocular lens (IOL) (near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient
15972984|NCT03090243|Device|Virtual colonoscopy|Inserting a Foley catheter through the anus, and gas inflating of the bowel.
15972985|NCT03090230|Device|Relay Pro Thoracic Stent-Graft System|RelayPro Thoracic Stent-Grafts are designed for the management of patients with aneurysms and penetrating ulcers within the descending thoracic aorta (DTA). The device is designed specifically for use in the thoracic aorta.
15972986|NCT03090217|Behavioral|Pelvic Physiotherapy|1) daily pelvic floor muscle training (PFMT).
15972987|NCT03090217|Behavioral|Standard care (SC)|1) daily vaginal dilator therapy (10 to 15 minutes) and 2) usual care management.
15972988|NCT03090204|Procedure|ultrasound measurements|ultrasound measurements of myocardial deformation of free wall right ventricle at 4 time points during a session of intermittent hemodialysis : before the intermittent hemodialysis connection, just after starting hemodialysis, after 1 hour of hemodialysis and 5 minutes before restitution
15972989|NCT03090191|Biological|Clostridium difficile vaccine|Toxoid-based Clostridium difficile vaccine
15972990|NCT03090191|Biological|Placebo|Normal saline solution (0.9% sodium chloride)
15972991|NCT03090178|Other|electronic-Patient Report Outcome and wear of a wristband actigraph|Measurement of sleep quality and quantity with wristband actigraph and evaluation of quality of life with electronic-Patient Report Outcome
15972992|NCT03090165|Drug|ribociclib|400mg PO
15972993|NCT03090165|Drug|ribociclib|600mg PO
15972994|NCT03090165|Drug|Bicalutamide|150mg PO
15972995|NCT03090152|Procedure|Periarticular injection (Deep injection)|"Deep injection of cocktail containing Bupivacaine with Epi, 30mL; Morphine, 8mg/mL, 1mL; Methyprednislone, 40mg/mL, 1mL; Cefazolin, 500mg in 10 mL; saline, 22mL into the anterior capsule, the periosteum, the gluteus maximus, and the abductor muscles and fascia lata."
15972996|NCT03090152|Procedure|Periarticular injection (Superficial injection)|Superficial injection of 40mL 0.25% Bupivacaine into subcutaneous tissue prior to wound closure.
15972997|NCT03090152|Drug|Bupivacaine|EPCA: Bupivacaine 0.06%.
15972998|NCT03090152|Drug|Placebo|EPCA: Saline.
15972999|NCT03090139|Drug|Anti-TNF Therapy|Anti-TNF therapy.
15973000|NCT03090126|Other|Therapeutic education|Questionnaires
15973001|NCT03090113|Drug|Shuxuetong Injection|intravenous drip
15973002|NCT03090113|Drug|Placebo Injection|intravenous drip
15973003|NCT03090100|Drug|Guselkumab|Participants will receive 1 injection of active guselkumab at Weeks 0, 4, 12, 20, 28, 36, and 44.
15973004|NCT03090100|Drug|Placebo|Participants will receive 1 injection of placebo at Weeks 0, 4, 12, 20, 28, 36, and 44 and 2 injections of placebo at Weeks 1, 2, 3, 8, 16, 24, 32, and 40.
15973005|NCT03090100|Drug|Secukinumab|Participants will receive 2 injections of active secukinumab at Weeks 0, 1, 2, 3, 4 and every 4 weeks (q4w) thereafter through Week 44.
15973006|NCT03090087|Biological|Hypoxia|The purpose is to test the effect of A2A adrenoceptor stimulation on the diameter of retinal arterioles during hypoxia in vivo
15973007|NCT03090087|Drug|Regadenoson|The purpose is to test the effect of A2A adrenoceptor stimulation on the diameter of retinal arterioles during hypoxia in vivo
15973008|NCT03090074|Behavioral|Diet regime|Randomization to moderate or extreme low-carbohydrate Mediterranean diet advice.
15973009|NCT03090074|Behavioral|Type of psychological support|Randomization to group-based psychological support according to ACT or to traditional cognitive behavioral therapy
15973010|NCT03090061|Diagnostic Test|Light induced fluorescence intraoral camera|assessment of marginal integrity of resin composite restorations by light induced fluorescence intraoral camera
15973011|NCT03090061|Diagnostic Test|Visual-tactile assessment method according to FDI criteria|assessment of marginal integrity of resin composite restorations by visual-tactile method that includes the use of mirror, FDI probe under good illumination condition,
15973012|NCT03090048|Drug|Vitamin A|Vitamin A 2-3 % concentration
15973013|NCT03090048|Drug|Azithromycin|azithromycin monohydrate
15973014|NCT03090035|Drug|Pegylated Interferon α2|Peg-INF was given in a dose of 180 μg/week
15973015|NCT03090035|Drug|Ribavirin|ribavirin 1200 mg/day to every patient for the period of 24 weeks for HCV genotype 2 & 3
15973018|NCT03090009|Drug|Flurbiprofen|100 mg twice a day for 14 days
15973019|NCT03090009|Drug|Placebo Oral Tablet|placebo group
15973020|NCT03089996|Procedure|Piezocision|The first maxillary premolars will be extracted with orthodontic purpose. After 3 months of extraction, the orthodontic alignment and dental leveling will be obtained and a 0.016x0.022 stainless steel wire will be placed, as well as orthodontic mini-implants (Morelli®, Sorocaba, SP, Brazil). The retraction of the canines will begin using closed nickel-titanium spring (120g). The piezocision surgery will be performed only in one side of the mouth. Three vertical piezo-incisions will be performed near the edentulous region and mesially to the canine root, in the vestibular alveolar cortical bone with the Ultrasonic instrument (BS1 insert Piezotome ™, Satelec Group Acteon Merignac, France) in depth of 3 mm. The intraoral digital scans will be performed with 7 and 14 days after the start of retraction, and then 14 in 14 days to a maximum period of 6 months. The patients will be advised to take analgesics (paracetamol or dipyrone) only if necessary.
15973176|NCT03088826|Drug|Acetaminophen|650 mg Acetaminophen
15973177|NCT03088813|Drug|Irinotecan liposome injection|IV
15973021|NCT03089996|Procedure|Corticotomy|The first maxillary premolars will be extracted with orthodontic purpose. After 3 months of extraction, the orthodontic alignment and dental leveling will be obtained and a 0.016x0.022 stainless steel wire will be placed, as well as orthodontic mini-implants (Morelli, Sorocaba, SP, Brazil).The retraction of the canines will begin using closed nickel-titanium spring (120g).The corticotomy surgery will be performed at the day of begining of canine retraction only in one side of the mouth.A mucoperiosteal flap will be raised from the extraction region to the mesial of the canine.Perforations will be performed using a number 2 spherical drill bit in low speed handpiece under irrigation, only in the cortical none depth.The intraoral digital scans will be performed with 7 and 14 days after the start of retraction, and then 14 in 14 days to a maximum period of 6 months.The patients will be advised to take analgesics (paracetamol or dipyrone) only if necessary.
15973022|NCT03089996|Device|Control Side|The first maxillary premolars will be extracted with orthodontic purpose. Fixed orthodontic appliance will be bonded (0.022x0.025 slot with MBT prescription in incisors and Standart in the other teeth) with a power arm welded in the bracks upper canines brackets. After 3 months of extraction, the alignment and dental leveling will be obtained and a 0.016x0.022 stainless steel wire will be placed, as well as orthodontic mini-implants (Morelli®, Sorocaba, SP, Brazil) between the roots of the second premolars and molars. At that time an intra-oral digital scan will be performed. The retraction of the canines will begin using closed nickel-titanium spring (120g of force) from the power arm to the mini-implant. No surgery will be done at this side. The intraoral digital scans will be performed with 7 and 14 days after the start of retraction, and then 14 in 14 days to a maximum period of 6 months.
15973023|NCT03089983|Drug|Buprenorphine Naloxone|Sublingual pill with a 10-day induction phase and a 6-month monitored-treatment plan, with a choice to continue after 6 months or switch to methadone.
15973024|NCT03089983|Drug|Methadone|Participants will receive daily or weekly doses of oral methadone.
15973025|NCT03089983|Drug|Isoniazid|Participants will be randomized to receive standard INH as TB treatment in prison for 26 weeks.
15973026|NCT03089983|Drug|Rifapentine|Participants will be randomized to receive short course INH + RIF as TB treatment in prison for 12 weeks.
15973027|NCT03089970|Diagnostic Test|Exhaled breath condensate collection|Breath from humans is cooled, condensed, and collected
15973028|NCT03089957|Drug|Ulinastatin|200,000 IU ulinastatin will be dissolved in 100 mL of 0.9% normal saline by continuous intravenous infusion for 1h, 3 times per day for 5 days.
15973029|NCT03089957|Other|Usual care|Usual care in ICU.
15973030|NCT03089944|Drug|Glecaprevir/Pibrentasvir|Tablet
15973031|NCT03089931|Procedure|Cervical spinal surgery|Cervical laminoplasty or anterior discectomy and fusion
15973032|NCT03089918|Drug|11C-JNJ-63779586|Participants will receive IV injection with 11C-JNJ-63779586 in Part A and Part B.
15973033|NCT03089905|Drug|Sevoflurane|Experimental arm: end tidal concentration of 0.6 -0.8% or less. Active comparator arm: end tidal concentration of 2.5-3.0% or greater.
15973034|NCT03089905|Drug|Remifentanil|Experimental arm: loading dose: 1 mcg/kg, infusion starting at 0.1 mcg/kg/min or greater.
15973035|NCT03089905|Drug|Dexmedetomidine|Experimental arm: loading dose:1mcg/kg, infusion: 1 mcg/kg/hr.
15973036|NCT03089879|Biological|GVGH Shigella sonnei 1790GAHB vaccine|Single dose administered at Day 1, by intramuscular injection.
15973037|NCT03089866|Drug|Midazolam (0.02mg/kg)|Quantify the effects of sedation with midazolam on auditory activation and cognitive performance (mini Mental State exam and complex reaction time).
15973038|NCT03089853|Device|Neuromuscular electrical stimulation (NMES)|Bipolar self-adhesive neuromuscular stimulation electrodes will be placed over the quadriceps femoris muscle group. Stimulation pulses (30 Hz trains of 300 μsec biphasic pulses) will be delivered using the neuromuscular electrical stimulator. A 5 sec on/25 sec off work/rest ratio will be used initially, progressing to 10 sec on/30 sec off. The patient will be fully supported while knee extensions are performed as the participant sits in a chair. Current from the stimulator will be manually increased and determined by patient tolerance. The goal for each patient will be to reach the highest tolerable amplitude (up to 100mA). Training will be performed on each quadriceps femoris muscle, 30 minutes/day, for 2 weeks including hospital stay till return to the COPD Clinic. This will be followed by pulmonary rehabilitation exercises delivered at home via a smart phone for an additional 10 weeks. Rehabilitation will involve aerobics, strength training as well as breathing exercises.
15973039|NCT03089840|Device|OrganOx metra|Following the routine retrieval procedure at the donor hospital the liver will be flushed with cold preservation solution and prepared for cannulation. The donor organ is then placed on the OrganOx metra device and will be perfused with warmed solution. The OrganOx metra device containing the donor organ is then transported to the recipient transplant centre. The donor liver is then removed from the device and flushed with standard of care preservation solution. Alternatively, where more practical, the livers will be transported to the University of Alberta hospital with ≤ 6 hours of cold storage and then placed on the metra™ for ≥ 4 hours. Implantation and reperfusion of the liver proceed as per the usual practice of the recipient transplant centre.
15973040|NCT03089814|Procedure|ischemic conditioning|Four cycles of 5-min inflation of pneumatic cuff on upper extremity up to 200 mmHg, followed by 5-min deflation with no pressure.
15973041|NCT03089801|Other|Tablet-Enabled Video Telehealth|Veterans referred for tablet-enabled video telehealth will receive a VA-issued tablet that can be used to communicate via video with health care providers (e.g., for chronic disease management, mental health treatment, palliative care).
15973042|NCT03089788|Other|Home-based test|Home-based tests in which the participant pets his/her cat until he/she reaches a certain symptom strength.
15973043|NCT03089788|Other|Skin test|Skin Prick Tests will be performed with registered cat allergen extract.
15973044|NCT03089775|Drug|BBI-2000|Experimental
15973045|NCT03089775|Drug|Vehicle|Vehicle Comparator
15973046|NCT03089775|Other|Multiple treatments|BBI-2000, Vehicle, Clobetasol Propionate, No treatment
15973047|NCT03089762|Biological|Intra-articular injection of SVF plus PRP|administering SVF and PRP intra-articularly into patients with osteoarthritis grade 1 and 2
15973048|NCT03089736|Behavioral|Education|Six education areas was offered: pain and pain physiology, pain medication, side effects and prevention of side effects, abuse of medications, sleep advice and advice on anxiety.
15973178|NCT03088813|Drug|Topotecan|IV
15973179|NCT03088800|Drug|Ibuprofen|Oral Ibuprofen at 10 mg/kg dose
15973049|NCT03089736|Behavioral|Self Care|The following instructions on self-care for pain relief: apply ice or crushed ice in the oral cavity, lubricating and antiseptic mouth rinses, pain relieving gel, tongue movements and gaps exercises. Prevention of dryness in the mouth and throat; saliva stimulants and saliva substitute agents in different preparations, increased measures of good oral hygiene. Physical activities and regular rest once to several times per day. Sleep restriction and measures to treat sleep disorders.
15973050|NCT03089736|Other|Treatment as usual (TAU)|pharmacological treatment + advices
15973051|NCT03089723|Behavioral|Visual Analog Scale (VAS)|Answer Visual Analog Scale (VAS) questionnaire at baseline, 1 month, 3 months and 6 months
15973052|NCT03089723|Behavioral|Range of Motion (ROM)|submitted to ROM at at baseline, 1 month, 3 months and 6 months
15973053|NCT03089723|Behavioral|Palmar grip strength|submitted to palmar grip strength at at baseline, 1 month, 3 months and 6 months
15973054|NCT03089723|Behavioral|Lateral grip strength|submitted to lateral grip strength at at baseline, 1 month, 3 months and 6 months
15973055|NCT03089723|Behavioral|Pulp-pulp pinch strength|submitted to pulp-pulp pinch strength strength at at baseline, 1 month, 3 months and 6 months
15973056|NCT03089723|Drug|Lavage with physiologic saline solution|Joint lavage with physiologic saline solution. After emptying of the joint, 1mL saline solution will be injected.
15973057|NCT03089723|Drug|Lavage with physiologic saline solution and Osteonil® Mini|Joint lavage with physiologic saline solution and Osteonil® Mini
15973058|NCT03089723|Behavioral|Quick Dash|Answer Quick Dash questionnaire at baseline, 1 month, 3 months and 6 months
15973059|NCT03089723|Behavioral|Sollerman Test|Perform Sollerman Test at baseline, 1 month, 3 months and 6 months
15973060|NCT03089710|Other|Mini-fluid challenge|Mini-fluid challenge test with 100mL colloid infusion in 1 min
15973061|NCT03089697|Biological|N-Rephasin® SAL200|A single dose of SAL200 (SAL-1, 3mg/kg) intravenous administration of the study drug, in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA
15973062|NCT03089697|Other|Placebo|A single dose of the formulation buffer (placebo), excluding the main ingredient of the study drug in addition to the conventional standard treatment (antibiotics) for MRSA/MSSA
15973063|NCT03089684|Other|No intervention|No intervention
15973064|NCT03089671|Other|Vitamin B (riboflavin, vitamin B2)|Vitamin B is a natural health product approved as a colouring agent.
15973065|NCT03089671|Other|5% Dextrose in Water (D5W)|5% Dextrose in Water is an irrigation/instillation fluid, commonly used in intravenous lines.
15973066|NCT03089658|Drug|Avelumab|Avelumab should be administered intravenously as per the recommended dose. Administration of Avelumab should continue according to the recommended schedule until disease progression or unacceptable toxicity.
15973067|NCT03089645|Biological|MEDI5083 monotherapy|Dose-escalation MEDI5083 monotherapy followed by monotherapy with Durvalumab
15973068|NCT03089645|Biological|MEID5083 with Durvalumab or Tremelimumab|Sequential Medi5083 with concurrent Durvalumab or Tremelimumab, and intermittent Medi5083 with concurrent Durvalumab
15973069|NCT03089645|Biological|Medi5083 with Durvalumab and Docetaxel|Medi5083 with concurrent Durvalumab and Docetaxel randomized against Durvalumab and Docetaxel
15973070|NCT03089632|Other|Gluten-free diet|One-month gluten-free diet
15973071|NCT03089619|Drug|Human-Spongiosa|after tooth extraction, the dental alveolus is filled with the bone substitute material (Human-Spongiosa) and covered with a membrane (mucoderm®)
15973072|NCT03089619|Device|collacone®|after tooth extraction, the dental alveolus is filled with the bone substitute material (collacone®) and covered with a membrane (mucoderm®)
15973073|NCT03089606|Diagnostic Test|FDG PET/CT scan|FDG PET/CT scan with IV contrast prior to treatment and C11-AMT PET scan co-registered with CT scan without IV contrast
15973074|NCT03089606|Diagnostic Test|C11-AMT PET scan|C11-AMT PET scan co-registered with CT scan without IV contrast after FDG PET/CT scan with IV contrast before pembrolizumab
15973075|NCT03089606|Drug|Pembrolizumab|200 mg Pembrolizumab IV administered over 30 minutes on day 1. Repeat every 3 weeks for 4 cycles, until progression, or subject withdrawal for other reasons
15973076|NCT03089606|Diagnostic Test|FDG PET/CT scan with IV contrast|At end of Pembrolizumab treatment
15973077|NCT03089593|Other|Extract of ginger|The volunteers will receive two capsules containing 200mg of extract of ginger with 5% of gingerols (20 mg). Breakfast will be offered (bread, butter, turkey ham and industrialized fruit juice) and the participants will have 15 minutes to eat it.
15973078|NCT03089593|Other|Placebo (Cellulose)|The volunteers will receive two capsules containing cellulose (placebo). Breakfast will be offered (bread, butter, turkey ham and industrialized fruit juice) and the participants will have 15 minutes to eat it.
15973079|NCT03089580|Device|Intense Pulsed Light Therapy|Intense pulsed light therapy is a non-invasive and non-laser light treatment that was approved in 1995 by the FDA for dermatology. Participants will receive a total of 4 treatments over the course of the study.
15973080|NCT03089580|Procedure|Sham Treatment|The sham treatment will mimic the IPL treatment but no light will be delivered. Sham treatment will be administered 4 times throughout the study.
15973081|NCT03089567|Drug|Sodium Fluoride|5% Sodium Fluoride Varnish used for dental caries prevention and desensitizer
15973082|NCT03089567|Drug|Silver diamine fluoride|38% Silver Diamine Fluoride used for dental caries prevention and desensitizer
15973083|NCT03089554|Drug|Therapeutic Intervention|Therapeutic Intervention
15973084|NCT03089541|Behavioral|Survey Arm|Contingency Management for completion of surveys and evidence of tobacco use status
15973085|NCT03089528|Device|Videolaryngoscopy|the trachea will be intubated with a videolaryngoscope
15973086|NCT03089528|Device|laringoscope|the trachea will be intubated with a laringoscope
15973087|NCT03089515|Diagnostic Test|Cardio-Pulmonary Exercise Testing (CPET)|This test helps determine if the decreased tolerance to exercise or shortness of breath with activity a patient is experiencing is caused by a cardiac disease, versus a pulmonary disease.
15973180|NCT03088800|Drug|APAP|Oral APAP at 15mg/kg dose
15973181|NCT03088787|Device|Nexfin measuremtents|There will be only observational recordings, no interevntion
15973182|NCT03088774|Other|Information material|Online web-application developed together with patients with low back pain
15973183|NCT03088761|Device|cuffed tracheal tube|the changes in cuff pressure will be determined using a cuff manometer
15973088|NCT03089502|Other|Exercise Rehabilitation|The intervention will consist of a walking or biking program performed at an intensity of 60-80% of VO2peak, progressing to a minimum of 150 minutes/week. Each session will include a warm up and cool down. One weekly exercise session will be supervised and participants will be expected to complete four additional aerobic training sessions at home or in the community each week. Resistance training will be introduced during the 4th week of the program and will consist of 10 exercises targeting all major muscle groups. One weekly resistance training session will be supervised following the aerobic training, and participants will be expected to complete one to two additional sessions at home or in the community each week. Weekly education sessions will follow the supervised exercise session.
15973089|NCT03089489|Diagnostic Test|lung biomarkers in organ donor for PGD in lung recipient|Lung biopsies in organ donor before and after cold ischemia
15973090|NCT03089476|Other|Evaluating atopy in infants|This study does not have an intervention. There is the evaluation of the predictive value of TEWL and STS in atopic infants at risk of developing eczema and TEWL and STS in parents of infants.
15973091|NCT03089476|Other|Evaluating TEWL and STS in adults|This study does not have an intervention. There is the evaluation of the predictive value of TEWL and STS in atopic infants at risk of developing eczema and TEWL and STS in parents of infants.
15973092|NCT03089463|Diagnostic Test|Observation|The primary objective is to employ the measurements of neuropathy, micro/macro-perfusion, and biomechanics of the foot mainly tissue stiffness and plantar pressure to determine the vulnerability of foot to mechanical trauma and ulceration. From the data collected it is proposed that a prognostic risk stratification system will be developed based on the range of parameters collected to identify those that are at highest risk of ulceration incident. Those that are classed as high risk are to be sub-stratified to increase the accuracy of the system in predicting ulceration. This will allow a patient-specific approach to be taken in the prevention of ulcers by providing adequate information to predict ulceration incident.
15973093|NCT03089450|Device|CGBio stent|Percutaneous Coronary Intervention
15973094|NCT03089450|Device|Biomatrix flex|Percutaneous Coronary Intervention
15973095|NCT03089437|Behavioral|Prolonged Standing|Subject will stand for 12 hours and undergo a high fat tolerance test the subsequent day
15973096|NCT03089437|Behavioral|Prolonged Sitting|Subject will sit for 12 hours and undergo a high fat tolerance test the subsequent day
15973097|NCT03089424|Device|Placebo PBMT|The PBMT treatments will be performed using the Multi Radiance Medical™ Super Pulsed Laser MR4™ console (Solon, OH, USA), with the LS50 (emitter with an area of 20 cm2) and SE25 (emitter with an area of 4 cm2) cluster probes as emitters. Nine sites will be irradiated at patient's lumbar region: 3 central sites, using the SE25 (without any dose, 0 J); and 6 sites in the same direction, but laterally (both sides, 3 at a side), using the LS50 (without any dose, 0 J). Patients will be treated during 12 sessions over a period of four weeks (three sessions/week). At each treatment session, patients will receive a total dose of 0 J. At the end of the 12 treatment sessions, patients will receive a total dose of 0 J.
15973098|NCT03089424|Device|PBMT active|The PBMT treatments will be performed using the Multi Radiance Medical™ Super Pulsed Laser MR4™ console (Solon, OH, USA), with the LS50 (emitter with an area of 20 cm2) and SE25 (emitter with an area of 4 cm2) cluster probes as emitters. Nine sites will be irradiated at patient's lumbar region: 3 central sites, using the SE25 (3000 Hz of frequency, 3 minutes of irradiation per site, 24.75 J per site, a totalizing 74.25 J irradiated from SE25); and 6 sites in the same direction, but laterally (both sides, 3 at a side), using the LS50 (1000 Hz of frequency, 3 minutes of irradiation per site, 24.30 J per site, a total of 145.80 J irradiated from LS50). Patients will be treated during 12 sessions over a period of four weeks (three sessions/week). At each treatment session, patients will receive a total dose of 220.05 J. At the end of the 12 treatment sessions, patients will receive a total dose of 2640.60 J.
15973099|NCT03089398|Procedure|Hybrid Coronary Revascularization (isolated LIMA-LAD)|sternal-sparing, off-pump, isolated LIMA-LAD revascularization
15973100|NCT03089398|Device|Hybrid Coronary Revascularization (PCI)|percutaneous revascularization of at least one non-LAD target
15973101|NCT03089398|Device|Percutaneous Coronary Intervention|Multi-vessel PCI with metallic drug-eluting stents (DES) including the LAD and or LM. Only FDA approved commercially available metallic drug-eluting stents may be used in this protocol.
15973102|NCT03089385|Other|Hypertension tool|An algorithm developed by staff at UHN to help manage hypertension in hemodialysis patients.
15973103|NCT03089372|Device|ARIES-ED device|The Dornier Aries-ED device will be used for the purpose of the study. LI-ESWT will be applied to the penile shaft 3 areas, and the 2 crura (two sites).
15973104|NCT03089346|Diagnostic Test|Magnetic Resonance Imaging (MRI) with Ultrashort Echo Time (UTE)|Magnetic Resonance Imaging (MRI) with Ultrashort Echo Time (UTE) pulse sequences on a 1.5T magnet (Avanto dot, Siemens) with 3D reconstruction of the bronchial tree using Neko-MR software in asthma in order to assess bronchial thickness.
15973105|NCT03089346|Diagnostic Test|Computed tomography (CT)|Computed tomography (CT) on a Definition 64 (Siemens) with 3D reconstruction of the bronchial tree using Neko-3D software in asthma in order to assess bronchial thickness.
15973106|NCT03089333|Drug|Dapagliflozin 10mg|Dapagliflozin at a dose of 10mg daily in combination with metoformin and current antihypertensive therapy for 12 weeks
15973107|NCT03089333|Drug|Glibenclamide 5Mg Tablet|Glibenclamide at a dose of 5mg daily in combination with metoformin and current antihypertensive therapy for 12 weeks
15973108|NCT03089320|Behavioral|Contingency Management Counseling|Contingency management (CM) is an efficacious treatment for individuals with substance use disorders. In line with operant conditioning, CM typically provides reinforcers (rewards) contingent upon attaining specified goals such as decreased substance use and/or abstinence.
15973109|NCT03089320|Behavioral|Addiction Physician Management|Patients in the CM plus stepped care arm who have PEth > 8 ng/ml at 3 months will progress to Step 2 and receive onsite treatment from an Addiction Psychiatrist (APM) in the HIV clinic. APM will provide care that is typically provided by physicians in specialty referral programs.
15973184|NCT03088748|Device|Journey II posterior cruciate retaining total knee arthroplasty|
15973185|NCT03088748|Device|Journey II posterior bi-cruciate retaining total knee arthroplasty|
15973186|NCT03088735|Procedure|Blastocyst-stage embryo transfer strategy|Intra-uterine transfer of blastocist if in cleavage embryo stage the oocyte recipient has a mínimum of 3 availables embryos with at least one of good quality to transfer and also the inta-uterine transfer of cleavage embryo (day 3) when the recipient doesn't have the previous criteria.
15973110|NCT03089320|Behavioral|Motivational Enhancement Therapy|"Patients in the CM plus stepped care arm who have PEth > 8 ng/ml at 3 months will progress to Step 2 and receive onsite Motivational Enhancement Therapy (MET) from the Social Worker in the HIV clinic.
~MET is grounded in research on processes of natural recovery during which patients move through stages of change - precontemplation, contemplation, determination, action, and maintenance. The Social Worker's role is to assist the patient in moving through the stages of change. MET uses motivational interviewing and reflective listening to help patients identify internal sources of motivation to support reductions in alcohol."
15973111|NCT03089307|Device|Dornier Aries- ED device|The Dornier Aries-ED device will be used for the purpose of the study. LI-ESWT will be applied to the penile shaft 3 areas, and the 2 crura (two sites).
15973112|NCT03089294|Device|Aries ED device|The Dornier Aries-ED device will be used for the purpose of the study. LI-ESWT will be applied to the penile shaft 3 areas, and the 2 crura (two sites)
15973113|NCT03089281|Device|CRT-D|Commercially approved quadripolar Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D) devices and future generations of BSC X4 CRT-D devices approved by the appropriate regulatory bodies will be included in the trial. All devices utilized in the study will include SmartDelay™ and must be capable of providing SmartDelay recommendations for both biventricular pacing (BiV) and Left Ventricular (LV) only pacing.
15973114|NCT03089268|Procedure|Colonoscopy|A colonoscopy will be performed to all individuals.
15973115|NCT03089268|Procedure|Polypectomy or biopsy|All lesions will be removed or biopsied during the procedure
15973116|NCT03089268|Genetic|Molecular analysis|"Molecular analysis will be performed in all colorectal cancers and in those polyps diagnosed with serrated lesion"
15973117|NCT03089242|Other|observation of microRNA expression|no intervention
15973118|NCT03089229|Drug|HAT01H Cream|HAT01H Cream will be applied twice daily. The research team will provide instructions for the correct application of the treatment. If a lesion disappears, patients will continue applying the cream twice daily to the area. No additional creams, lotions or soaps other than provided test products will be allowed throughout the duration of the study.
15973119|NCT03089229|Drug|Vehicle Cream|Vehicle Cream will be applied twice daily. The research team will provide instructions for the correct application of the treatment. If a lesion disappears, patients will continue applying the cream twice daily to the area. No additional creams, lotions or soaps other than provided test products will be allowed throughout the duration of the study.
15973120|NCT03089216|Procedure|Combined Bleaching(2x20)|one clinical session with two applications of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.
15973121|NCT03089216|Procedure|Combined Bleaching(2x20) with arginine|one clinical session with two applications of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.
15973122|NCT03089216|Procedure|Combined Bleaching (1x20)|one clinical session with one application of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.
15973123|NCT03089216|Procedure|Combined Bleaching(1x20) with arginine|one clinical session with one application of 35% hydrogen peroxide of 20 minutes each. 10% carbamide peroxide for two hours daily over the course of two weeks.
15973124|NCT03089216|Drug|8% arginine and calcium carbonate|using during all the treatment.
15973125|NCT03089203|Biological|CART T cells|1-3x10^7
15973126|NCT03089203|Biological|CART T cells|1-3 x 10^8
15973127|NCT03089203|Drug|Cyclophosphamide 1g/m^2|day -3 of cohort 3 subjects only
15973128|NCT03089203|Biological|CART T cells|MTD given in Cohort 3 only
15973129|NCT03089190|Dietary Supplement|DC7-2|Effects on appetite
15973130|NCT03089190|Dietary Supplement|DC7-2 + potato protein isolate|Effects on appetite
15973131|NCT03089190|Dietary Supplement|Potato protein isolate|Effects on appetite
15973132|NCT03089190|Dietary Supplement|Placebo|Inactive whey protein, not expected to affect appetite.
15973133|NCT03089177|Behavioral|Community Garden Intervention|"The investigators will recruit prospective adult gardeners who have not been gardening for the past two years and who are listed on Denver Urban Gardens (DUG) wait lists. Individuals randomized to the garden intervention will receive a standardized garden resource package, which includes the following:
~A garden plot in a Denver Urban Garden
~Seeds and plant starts
~Introductory gardening workshop
~Social events including garden-specific events and garden mentoring.
~The Wait List Control group will remain on the community gardening wait lists and will not receive these resources.
~Duration of the intervention is 1 year."
15973134|NCT03089164|Diagnostic Test|Right heart catheterization|Each patient will have variables measured supine, sitting and standing positions
15973135|NCT03089151|Behavioral|Community Garden Intervention|"The investigators will recruit 30 prospective gardeners who have not been gardening for the past two years and who are listed on Denver Urban Gardens (DUG) wait lists. DUG randomly assigns people on each garden wait list to available plots, using a lottery. This creates a natural randomized experiment. Participants randomized to the garden intervention will receive a standardized garden resource package, which includes the following:
~A garden plot in a Denver Urban Garden
~Seeds and plant starts
~Introductory gardening workshop
~Social events including garden-specific events and garden mentoring.
~The non-gardening group will remain on the DUG wait lists and will not receive these resources.
~Duration of the intervention is 1 year."
15973136|NCT03089138|Drug|Regan Tangjiang|The treatment duration is 3 consecutive days.
15973137|NCT03089125|Behavioral|Dyspnea Intervention|"Dyspnea intervention will be administered over two sessions
~Patients will receive:
~Psychoeducation
~Relaxation training for reducing physiological stress
~Behavioral techniques for managing acute breathlessness"
15973138|NCT03089125|Other|Usual Care|Patients will receive any usual care for their dyspnea as deemed appropriate by their clinicians
15973139|NCT03089112|Drug|HGP1607|
15973140|NCT03089112|Drug|HGP1501|
15973141|NCT03089112|Drug|HGP1607+HGP1501|
15973142|NCT03089099|Other|Blood drawing|Blood drawing
15973143|NCT03089086|Biological|Licensed 4CMenB vaccine|Two doses (0.5 mL each) of Bexsero ® vaccine at least 1 month to <3 months apart in adolescents.
15973144|NCT03089073|Drug|Desmopressin|60μg or 120μg once daily at bedtime
15973145|NCT03089060|Device|Silicone Finger cap|Treatment with silicone finger cap
15973146|NCT03089060|Device|Film Dressing|Treatment with conventional film dressing
15973147|NCT03089047|Biological|Transfusion of rejuvenated and washed autolgous RBCs|Rejuvenation refers to the process of adding a mix of solutes (Rejuvesol®, Citra Labs, Braintree, MA; consists of sodium pyruvate, inosine, adenine, mono- and dibasic sodium phosphate) to older, stored (i.e., 2-3 DPG-depleted) blood to immediately restore 2,3-DPG and ATP levels in the stored red blood cells15. Rejuvenation was originally developed to prolong the storage life of rare-phenotype RBC units. It is FDA-approved for use in RBC units stored in CPD, CPDA-1, and AS-1. The major contraindication for the use of Rejuvesol® is in RBC units stored for fewer than 6 days due to high baseline 2,3-DPG and ATP levels. Rejuvenated units must be washed prior to administration to remove residual Rejuvesol that is not approved for iv administration in such concentrations.
15973148|NCT03089047|Biological|Transfusion of washed autolgous RBCs|Autologous RBCs will be washed prior to transfusion to maintain blinding and equalize volume and Hct with the rejuvenated and washed intervention arm
15973149|NCT03089021|Other|mulligan mobilization|mobilization with movement for spinous process or facet joint.
15973150|NCT03089021|Other|maitland mobilization|posterioanterior of spinous process or facet joint.
15973151|NCT03089008|Other|Eccentric exercises|
15973152|NCT03089008|Other|Stretching exercises|
15973153|NCT03088995|Diagnostic Test|Pilot study|Pilot study of HIV and viral hepatitis B and C screening in surgery
15973154|NCT03088982|Other|Questionnaire|"FPs who had agreed to participate worked according to the following plan: first, the multimorbid patient was asked to give his/her consent to participate in the study once the terms had been explained to him/her. After that, FPs completed a questionnaire about their patient.
~The purpose of this questionnaire was to explore potential decompensation risk factors within the themes and subthemes of multimorbidity."
15973155|NCT03088969|Other|questionnaire RTWSE|The evaluation of the self-efficiency perceived of return in the work of the patients by a validated auto-questionnaire is thus an additional objective parameter determining the risk factors of unfavorable evolution of the patients with Low Back Pain. This parameter also allows highlight other levers of actions in the therapeutic education.
15973156|NCT03088956|Other|Assessments|Cognitive, Behavioral and Functional as described in the Outcome Measures
15973157|NCT03088943|Other|TTE Apical 4 Chamber View|We will measure a number of echocardiography parameters by TTE (apical 4 Chamber View) prior to and after induction
15973158|NCT03088943|Other|TEE dTG View|We will measure a number of echocardiography parameters by TEE (dTG View) prior to cardiopulmonary bypass and after cardiopulmonary bypass (atrially paced at 80, 100, and 120 bpm)
15973159|NCT03088943|Other|TEE ME 4C View|We will measure a number of echocardiography parameters by TEE (ME 4C View) prior to cardiopulmonary bypass and after cardiopulmonary bypass (atrially paced at 80, 100, and 120 bpm)
15973160|NCT03088930|Drug|Crizotinib|Crizotinib is an oral receptor tyrosine kinase inhibitor of ALK, Hepatocyte Growth Factor Receptor (HGFR, c-Met), and ROS1 (c-ros). Crizotinib will be given as a neoadjuvant therapy before surgical resection. The recommended dose of crizotinib is 250mg orally. Participants on this trial will receive this dose, unless dose modification is necessary.
15973161|NCT03088904|Biological|FluMist® Quadrivalent|LAIV4 vaccine dosage is 0.2 mL. Vaccine will be administered as an intranasal spray. Each sprayer contains a single dose of FluMist® Quadrivalent; approximately one-half of the contents should be administered into each nostril. 0.1 mL (i.e., half of the dose from a single FluMist sprayer) is administered into each nostril while the recipient is in an upright position. Insert the tip of the sprayer just inside the nose and rapidly depress the plunger until the dose-divider clip stops the plunger. The dose divider clip is removed from the sprayer to administer the second half of the dose (0.1 mL) into the other nostril.
15973162|NCT03088904|Biological|Fluzone® Quadrivalent vaccine|IIV4 vaccine will be administered as a 0.5 mL dose, with a sterile, disposable syringe and needle by IM injection into the deltoid muscle.
15973163|NCT03088891|Other|Antioxidant-rich snacks|Bama Smoothies (Bama, Oslo, Norway), Freia Premium Dark Chocolate (Freia, Oslo, Norway), Walnuts (Eldorado, Norway), Dried fruits and berries (Cranberries, Gojiberries, apricots)(Bama, Oslo, Norway and Rema 1000, Norway)
15973164|NCT03088891|Other|Control snacks|Milkshake (Tine, Oslo, Norway), YT restitusjonsdrikk (Tine, Oslo, Norway), Bixit (Sætre, Oslo, Norway), Ritz (Mondelez, Oslo, Norway), White chololate (Freia, Oslo, Norway)
15973165|NCT03088878|Drug|Cirmtuzumab (2-16 kg/mg) plus Ibrutinib|Participants will receive escalating doses of cirmtuzumab (2-16 mg/kg) administered IV every 2 weeks for 5 administrations and then every 4 weeks thereafter, plus ibrutinib (420 or 560 mg) orally once daily, starting at week 4.
15973166|NCT03088878|Drug|Cirmtuzumab (300mg) plus Ibrutinib|Participants will receive cirmtuzumab (300 mg) administered IV every 2 weeks for 5 administrations and then every 4 weeks thereafter, plus ibrutinib (420 mg) orally once daily.
15973167|NCT03088878|Drug|Cirmtuzumab (600 mg) plus ibrutinib|Participants will receive cirmtuzumab (600 mg) administered IV every 2 weeks for 5 administrations and then every 4 weeks thereafter, plus ibrutinib (420 mg) orally once daily.
15973168|NCT03088878|Drug|Cirmtuzumab (RDR) plus ibrutinib|Participants will receive cirmtuzumab (600 mg) administered IV every 2 weeks for 3 administrations and then every 4 weeks thereafter, plus ibrutinib (420 or 560 mg) orally once daily
15973169|NCT03088878|Drug|Cirmtuzumab plus ibrutinib|Arm A: Participants will receive cirmtuzumab (600 mg) administered IV every 2 weeks for 3 administrations and then every 4 weeks thereafter, plus ibrutinib (420 mg) orally once daily.
15973170|NCT03088878|Drug|Ibrutinib alone|Arm B: Participants will receive ibrutinib (420 mg) orally once daily
15973171|NCT03088878|Drug|Cirmtuzumab + Ibrutinib (Arm A, B, C and D)|Participants will receive cirmtuzumab (600 mg) administered IV every 2 weeks for 3 administrations and then every 4 weeks thereafter, plus ibrutinib (560 mg) orally once daily.
15973172|NCT03088865|Diagnostic Test|aspirating first blood volume into a regular blood collection tube|order of blood drawing
15973173|NCT03088852|Drug|Magnesium Citrate 100 MG|initial intravenous treatment: Patients with magnesium levels 1-1.5 mg/dL will receive 2-4 grams of magnesium sulfate in the first 24 hours. Patients with magnesium levels 1.6-1.9 mg/dL will receive 1 gram of magnesium sulfate. participants with magnesium level ≥1 mg/dL, will be randomized, and oral magnesium therapy, Magnesium Citrate, ( or no treatment) will be started, and continued for at least three months. The experimental group will receive 400mg magnesium daily in two divided doses.
15973174|NCT03088826|Drug|Morphine Sulfate|15mg PO morphine sulfate
15973175|NCT03088826|Drug|Oxycodone|10mg Oxycodone
15973187|NCT03088735|Procedure|Cleavage-stage embryo transfer strategy|Inta-uterine transferring of cleavage embryo transfer (day 3 of develpment) in oocyte recipients
15973188|NCT03088722|Other|Training CHEWs to provide contraceptive implants|Training CHEWs to provide contraceptive implants
15973189|NCT03088709|Drug|Cyclophosphamide|IV medication given for prevention of graft versus host disease.
15973190|NCT03088709|Drug|Tacrolimus|IV medication given for prevention of graft versus host disease.
15973191|NCT03088709|Drug|Mycophenolate mofetil|IV medication given for prevention of graft versus host disease.
15973192|NCT03088709|Other|Haploidentical Stem Cell Transplantation|A stem cell transplant that involves matching a patient's tissue type, specifically their human leukocyte antigen (HLA) tissue type, with that of a related donor.
15973193|NCT03088696|Other|stimulation|activation of the acupuncture point
15973194|NCT03088696|Other|no stimulation|no activation of the acupuncture point
15973195|NCT03088683|Device|Nathanson Retractor|Liver will be retracted with Nathanson retractor
15973196|NCT03088683|Device|Reveel Retractor|Liver will be retracted with Reveel retractor
15973197|NCT03088670|Drug|Gosogliptin|20 mg per day, dose titration to 30 mg per day at Week 4 as required Administration: orally
15973198|NCT03088670|Drug|Vildagliptin|50 mg per day, dose titration to 100 mg per day at Week 4 as required (50 mg twice a day) Administration: orally
15973199|NCT03088670|Drug|Metformin|"1000 mg per day starting Week 12 (500 mg twice a day), dose titration to 2000 mg per day at Week 16 as required (1000 mg twice a day).
~Administration: orally"
15973200|NCT03088644|Drug|JNJ-54175446|JNJ-54175446 up to 600 mg suspension for oral dose administration.
15973201|NCT03088644|Drug|18F-JNJ-64413739|18F-JNJ-64413739 fluid for injection administered intravenously.
15973202|NCT03088631|Drug|Metformin|will receive metformin (1500 mg/day) starting with the commencement of oral contraceptive pills in the preceding cycle until the day of human chorionic gonadotropin triggering.
15973203|NCT03088631|Other|Placebo|will receive corn-flour placebo tablets (three tablets daily).
15973204|NCT03088618|Procedure|Nasal septoplasty|Type of surgery
15973205|NCT03088605|Drug|TOP1630 Ophthalmic Solution|Bilateral ocular drug administration
15973206|NCT03088605|Drug|Placebo to TOP1630 Ophthalmic Solution|Bilateral ocular drug administration
15973207|NCT03088592|Device|Deep Brain Stimulation|Subjects will have awake or asleep DBS surgery with STN or GPi placement. Microelectrode recordings will define the electrophysiological target prior to lead implantation. Cortical recordings will be done using µECoG grids (2.0 x 0.8 cm) placed over the cortex through the same burr hole used for lead implantation. Neural recordings will be made continuously throughout the procedure: before, during, and after DBS, and at all levels of anesthesia. A pulse generator will be connected and implanted either during the operation or within 7-10 days post-operatively. Subjects will be admitted overnight for observation with anticipated discharge the next morning. The researchers will also be collecting other routine data points (length of surgery, stereotactic accuracy, length of hospital stay, and post-operative complications).
15973208|NCT03088579|Device|GammaTile seed loader|Patients are chosen based on symptomatic tumor/radiographic finding of a surgically accessible mass. Surgery will be done in usual fashion. A cavity will be left where the tumor was. Size of operative bed will be measured using a surgical dissector and standard operating room ruler. A sheet of surgical fabric may be used to estimate size of cavity. If pathology is positive the study treatment will continue. If not, patient will not be on trial. If patient is eligible, radiation oncologist will form custom implants using a seed(s) of Cesium-131, with other biocompatible materials used to achieve maximum dosimetric conformality. Surgeon will place constructs into cavity until the operative bed is fully addressed. Implant is not expected to migrate. Surgicel, bioglue or similar material may be used to secure seeds. Wound will be closed in standard fashion. The last 10 patients will be asked to participate in an effort to gauge costs related to radiation portion of treatment.
15973209|NCT03088566|Procedure|The D-Foot method|The D-Foot method is a standardised routine of foot screening. The D-Foot i web program aimed to be used on a surf plate.
15973210|NCT03088566|Procedure|Conventional foot screening|The foot screening is performed with clinical conventional methods.
15973211|NCT03088553|Drug|Therapeutic Drug Monitoring|Trough concentration of ganciclovir and viral load measurement at each follow-up visit.
15973212|NCT03088540|Drug|Pemetrexed|Patients will be administered pemetrexed chemotherapy as per protocol with either cisplatin or carboplatin
15973213|NCT03088540|Drug|Paclitaxel|Patients will be administered paclitaxel chemotherapy as per protocol with either cisplatin or carboplatin
15973214|NCT03088540|Drug|Gemcitabine|Patients will be administered gemcitabine chemotherapy as per protocol with either cisplatin or carboplatin
15973215|NCT03088540|Drug|Cisplatin|Administered with either Pemetrexed, Paclitaxel or gemcitabine.
15973216|NCT03088540|Drug|Carboplatin|Administered with either Pemetrexed, Paclitaxel or gemcitabine.
15973217|NCT03088540|Drug|cemiplimab|Patients will be administered cemiplimab as per protocol.
15973218|NCT03088527|Drug|RAD140|RAD140 will be supplied as formulated drug-in-capsules for oral administration.
15973219|NCT03088514|Dietary Supplement|Beetroot juice|Beetroot juice (70ml daily) with or without inorganic nitrate
15973220|NCT03088501|Behavioral|Interactive voice response system|IVR allows the pregnant women, their family members to interact with a computer system using a telephone.Through IVR, women receive a 2-3 minute call that reminds them of lab test, their next follow-up visit and also provides information on child care attendance, breastfeeding, introduction of solid foods, motor development, and sleep.
15973221|NCT03088501|Behavioral|Mother and baby affairs workshop|Mother and baby affairs workshop will involve antenatal workshop and counseling for parents. The intervention will involve brief talk by health professionals, quiz activities, role-plays on personal hygiene, nutritional food, institutional delivery, precautions at the time of delivery, caring for the baby, feeding of colostrum, homemade baby food, immunization, and family planning measures.
15973222|NCT03088488|Diagnostic Test|fasting venous blood samples|
15973223|NCT03088475|Behavioral|nurse-led smartphone-based self-management programme|The participants in the experimental group will undergo nurse-led smartphone-based self-management programme (NSSMP), a 6-month programme comprising an individual education session, and a newly developed smartphone App as a self-help education resource
15973337|NCT03087708|Other|Quality-of-Life Assessment|Ancillary studies
15973224|NCT03088475|Behavioral|exiting nurse-led diabetes service|the patients in the control group will receive the exiting nurse-led diabetes service (i.e. NDS) provided by the hospital
15973225|NCT03088462|Other|Psychiatric management|Routine treatment for bipolar disorder with a psychiatrist including prescription of medications and potentially other treatments such as individual, group or light therapy.
15973226|NCT03088462|Behavioral|Psychosocial treatment|Any psychosocial treatment participant is involved in such as individual therapy, group therapy, or support groups.
15973227|NCT03088462|Behavioral|LiveWell Program|Participants work with a health coach to facilitate use of a smartphone application designed for people with bipolar disorder.
15973228|NCT03088436|Device|preoperative prone MRI and supine second-look ultrasound data|Patients were examined using a standard clinical MRI protocol in the prone position with both arms placed above the head. Second-look ultrasonographies were performed. Patients were instructed to lie supine, with their hands behind their heads.
15973229|NCT03088423|Radiation|SBRT delivers high dose selective irradiation with millimeter precision to a small volume. The Cyberknife® is a robotic SBRT dedicated device that can deliver 100 to 200 photobeams to the target|Seven to ten days before the scheduled CT, 2-4 fiducial markers were implanted percutaneously 2 to 5 cm next to the lesion under sonographic guidance following administration of local anesthesia, thus allowing real-time tracking during treatment. The total dose delivered was 45 Gy on the 80% isodose, in three fractions over 10 days. Gross tumor volume (GTV) was defined as the tumor mass that could be discerned by diagnostic imaging. An isotropic margin of 5 mm was added to account for the microscopic extension (clinical target volume, CTV) and another 3 mm margin was added to compensate for uncertainties regarding the position (previsional target volume, PTV)
15973230|NCT03088410|Drug|Zidovudine|neonatal 4 weeks prophylactic
15973231|NCT03088410|Drug|Nevirapine|neonatal 4 weeks prophylactic
15973232|NCT03088397|Behavioral|Patient Decision Aid|One sheet of postpartum contraceptive information arranged in a grid.
15973233|NCT03088397|Behavioral|Website|Patient directed to website with information on various contraceptive methods.
15973234|NCT03088397|Behavioral|Shared- Decision Making Counseling|Counseling using principles of shared-decision making
15973235|NCT03088384|Drug|Ketamine|Psychological survey instruments administered before and after a series of six low-dose infusions of ketamine.
15973236|NCT03088371|Drug|Bupivacaine 0.25%|For psoas sciatic block.
15973237|NCT03088371|Other|Pajunk Needle|For local anaesthesia application in psoas sciatic block
15973238|NCT03088371|Other|Portex combined spinal epidural kit|For combined spinal epidural anaesthesia
15973239|NCT03088371|Drug|Lidocaine 1%|For psoas sciatic block.
15973240|NCT03088371|Drug|Bupivacaine 0.5%|For spinal anaesthesia in combined spinal epidural anaesthesia.
15973241|NCT03088371|Drug|Lidocaine 2 %|For psoas sciatic block in the post-operative period
15973242|NCT03088371|Drug|Bupivacaine 0.125 %|For combined spinal epidural in the post-operative period.
15973243|NCT03088358|Drug|TeaRx|
15973244|NCT03088358|Drug|Enoxaparin|
15973245|NCT03088345|Drug|Vasopressin, Arginine|Subjects will be started on a blinded continuous infusion of study drug/placebo in the OR, immediately following the completion of the MUF at 0.3 mU/kg/min. All caregivers will be blinded to the arm assignment. The infusion will run for 20 hours, at which time it will be weaned off at 0.1 mU/hr, over 3 hours.During the active study period, the care team will treat subjects per SOC, using any preferred medication to correct low cardiac output; there is no restriction on using open-label vasopressin during the active study treatment period.
15973246|NCT03088345|Drug|Placebo|Subjects will be started on a blinded continuous infusion of study drug/placebo in the OR, immediately following the completion of the MUF at 0.3 mU/kg/min. All caregivers will be blinded to the arm assignment. The infusion will run for 20 hours, at which time it will be weaned off at 0.1 mU/hr, over 3 hours.During the active study period, the care team will treat subjects per SOC, using any preferred medication to correct low cardiac output; there is no restriction on using open-label vasopressin during the active study treatment period.
15973247|NCT03088332|Procedure|Endoscopic gastroplasty|Vertical endoscopic gastroplasty
15973248|NCT03088306|Drug|Standard analgesia use [Oxygen]|A protocol directed and clinically appropriate post-operative analgesia. In this study, standard post-operative analgesia is defined as: oxygen, volatile anesthesia, fentanyl, hydromorphone.
15973249|NCT03088306|Drug|Standard analgesia use [Hydromorphone]|A protocol directed and clinically appropriate post-operative analgesia. In this study, standard post-operative analgesia is defined as: oxygen, volatile anesthesia, fentanyl, hydromorphone.
15973250|NCT03088306|Drug|Standard analgesia use [Volatile Anesthesia]|A protocol directed and clinically appropriate post-operative analgesia. In this study, standard post-operative analgesia is defined as: oxygen, volatile anesthesia, fentanyl, hydromorphone.
15973251|NCT03088306|Drug|Standard analgesia use [Fentanyl]|A protocol directed and clinically appropriate post-operative analgesia. In this study, standard post-operative analgesia is defined as: oxygen, volatile anesthesia, fentanyl, hydromorphone.
15973252|NCT03088306|Drug|Multi-modal pain management [Acetaminophen + Gabapentin]|Administration of acetaminophen (1 gm po) plus gabapentin (600-1200 mg po) in the preparation area prior to surgery; pre-induction opioid titration with fentanyl until pain is relieved and/or respiratory depression ensues; intravenous ketamine (1 mg/kg load prior to incision then 10 mcg/kg/min) during surgery; acetaminophen, valium plus gabapentin during hospitalization; and prescription for acetaminophen, valium plus gabapentin at discharge.
15973253|NCT03088306|Drug|Multi-modal pain management [Fentanyl]|Administration of acetaminophen (1 gm po) plus gabapentin (600-1200 mg po) in the preparation area prior to surgery; pre-induction opioid titration with fentanyl until pain is relieved and/or respiratory depression ensues; intravenous ketamine (1 mg/kg load prior to incision then 10 mcg/kg/min) during surgery; acetaminophen, valium plus gabapentin during hospitalization; and prescription for acetaminophen, valium plus gabapentin at discharge.
15973254|NCT03088306|Drug|Multi-modal pain management [Intravenous Ketamine]|Administration of acetaminophen (1 gm po) plus gabapentin (600-1200 mg po) in the preparation area prior to surgery; pre-induction opioid titration with fentanyl until pain is relieved and/or respiratory depression ensues; intravenous ketamine (1 mg/kg load prior to incision then 10 mcg/kg/min) during surgery; acetaminophen, valium plus gabapentin during hospitalization; and prescription for acetaminophen, valium plus gabapentin at discharge.
15973255|NCT03088306|Drug|Multi-modal pain management [Valium + Gabapentin]|Administration of acetaminophen (1 gm po) plus gabapentin (600-1200 mg po) in the preparation area prior to surgery; pre-induction opioid titration with fentanyl until pain is relieved and/or respiratory depression ensues; intravenous ketamine (1 mg/kg load prior to incision then 10 mcg/kg/min) during surgery; acetaminophen, valium plus gabapentin during hospitalization; and prescription for acetaminophen, valium plus gabapentin at discharge.
15973256|NCT03088293|Drug|Infliximab|Patients will receive prednisone and infliximab (5 mg/kg at week 0, 2, 6, 11 and 16 as an intravenous (IV) infusion) in association with low-dose methotrexate (10 mg/week) for 16 weeks.
15973257|NCT03088293|Drug|Cyclophosphamide|Patients will receive prednisone and cyclophosphamide intravenously (700 mg/m2 every 4 weeks intravenously) (n=25) for 16 weeks.
15973258|NCT03088280|Drug|Thymoglobulin|reduced dose (3mg/Kg)
15973259|NCT03088267|Drug|amphetamine extended-release oral suspension, 2.5 mg/mL|5 mL1 (5 mg), 7 mL (17.5 mg) or 8 mL (20 mg) PO
15973260|NCT03088267|Drug|Placebo extended-release oral suspension|6, 7 or 8 mL PO
15973261|NCT03088254|Drug|Group I (Telmisartan 80 mg, Amlodipine 10 mg, Rosuvastatin 20 mg)|Twinstar(80/10 mg) and Rosuvastatin 20 mg for 8 weeks
15973262|NCT03088254|Drug|Group II (Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin placebo)|Twinstar(80/10 mg) and Rosuvastatin placebo for 8 weeks
15973263|NCT03088254|Drug|Group III (Telmisartan 80 mg, Amlodipine placebo, Rosuvastatin 20 mg)|Twinstar placebo, Amlodipine 10 mg and Rosuvastatin 20 mg for 8 weeks
15973264|NCT03088241|Other|switch|switch to second-line ART
15973265|NCT03088228|Diagnostic Test|gingival crevicular fluid collection|
15973266|NCT03088215|Device|shock-waves|Application of shock-waves (radial and focused)
15973267|NCT03088202|Other|Educational program|E-learning lectures, group exercises, skills training
15973268|NCT03088202|Other|Standardized care pathways|Pathways for systematic follow-up
15973269|NCT03088202|Other|Early palliative care|Compulsory referral to palliative care at inclusion
15973270|NCT03088176|Drug|Talimogene Laherparepvec 1 Million Pfu/Ml Inj,Susp,1Ml,Vil|Up to 4mL administered on C1D1 intratumorally
15973271|NCT03088176|Drug|Talimogene Laherparep 100 Mil Pfu/Ml 1Ml|Up to 4 ML administered on Week 4 Day 1 and every 2 weeks thereafter
15973272|NCT03088176|Drug|Dabrafenib|150mg PO qday
15973273|NCT03088176|Drug|Trametinib|2mg PO qday
15973274|NCT03088163|Device|Diffusion weighted magnetic resonance imaging|The enrolled colorectal liver metastases patients will receive DWI-MRI screening to evaluate the liver metastases before the chemotherapy, after the first cycle of chemotherapy and in the regular efficacy evaluation time, respectively.
15973275|NCT03088150|Procedure|Thermal ablation|Patients will undergo either radiofrequency ablation (RFA) or microwave ablation (MWA).
15973276|NCT03088150|Procedure|Surgical resection|In case of randomization to surgical resection, the surgeon will remove all target lesions as well as all additional unablatable lesions.
15973277|NCT03088137|Drug|Follitropin alfa (Gonal-f)|Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
15973278|NCT03088137|Drug|Follitropin alfa (Primapur)|Subcutaneous injection, fixed starting dose 150 IU for 5 days, maximum of 16 days of ovarian hyperstimulation
15973279|NCT03088124|Drug|Apalutamide|Patients will take orally everyday 240 mg of Apalutamide.
15973280|NCT03088111|Other|Collection of samples|To the extent possible, blood samples will be collected from all subjects prior to infusion and at specified time points post-infusion to determine serum obiltoxaximab concentrations and ATA titers. Scavenged blood samples can be utilized, if acceptable, to maximize sample analyses for pharmacokinetic and other investigational parameters. Data on other relevant laboratory testing will only be collected and evaluated if available in the subject's record (eg, protective antigen (PA), anti-PA, anti-lethal factor (LF), anti-edema factor, IgG antibodies, anthrax lethal toxin neutralizing activity, presence of anthrax LF, incidence and duration of B. anthracis bacteremia, and demonstration of B. anthracis antigens in tissues).
15973281|NCT03088111|Biological|Obiltoxaximab|Obiltoxaximab standard of care
15973282|NCT03088098|Device|LAAO|Left atrial appendage occlusion for stroke prevention
15973283|NCT03088085|Procedure|Self-mobilization|Subjects will mobilize thoracic spine and ribs with a foam roller every night before going to bed.
15973284|NCT03088085|Procedure|Sleep Education|Subjects will be educated on sleep hygiene in order to improve likelihood of having good sleep.
15973285|NCT03088072|Drug|Edoxaban|"Edoxaban 60mg once daily in patients with CrCl >50- ≤95 mL/min, or 30mg once daily in patients with CrCL 15-50 mL/min.
~If at 6 week TEE LAA closure is deemed acceptable by the operator (i.e., peri-device flow <5mm), edoxaban will be discontinued. Aspirin 81mg daily and clopidogrel 75mg daily will be administered until 6-month follow-up, then clopidogrel will be discontinued.
~If LAA unacceptable on 6-week TEE due to peri-device flow ≥5mm, edoxaban will be continued for an additional 6 weeks, and LAA reassessed by TEE If device thrombus is present at 6-week TEE, patient will be transitioned to aspirin 81 mg daily and adjusted-dose warfarin (goal INR, 2.0-3.0), and LAA reassessed by TEE in 6 weeks; further warfarin will be continued according to operator preference."
15973286|NCT03088072|Device|WATCHMAN LAA Closure|Per Inclusion Criteria, enrolled subjects must have a successful Left Atrial Appendage (LAA) Closure using the WATCHMAN Device
15973287|NCT03088072|Drug|Aspirin and Clopidogrel|"If at 6 week TEE LAA closure is deemed acceptable by the operator edoxaban will be discontinued, and aspirin 81mg daily and clopidogrel 75mg daily will be administered until 6-month follow-up. Then clopidogrel will be discontinued.
~Aspirin 325mg daily rather than 81mg daily can be administered according to operator preference after the 6-week follow-up visit."
15973288|NCT03088072|Drug|Aspirin and Warfarin|If device thrombus is present at 6-week TEE, patient will be transitioned to aspirin 81 mg daily and adjusted-dose warfarin (goal INR, 2.0-3.0), and LAA reassessed by TEE in 6 weeks; further warfarin will be continued according to operator preference.
15973289|NCT03088059|Drug|Afatinib|Afatinib 40 mg given orally, once daily, 1 cycle is 28 days
15973290|NCT03088059|Drug|Palbociclib|Palbociclib 125 mg given orally, once daily, 1 cycle is 28 days (21 days on treatment, then 7 days off)
15973291|NCT03088059|Drug|standard of care|Methotrexate, Paclitaxel, Docetaxel, Carboplatin, 5-Fluorouracil, Bleomycine, Gemcitabine, Mitomycine or Best supportive care
15973437|NCT03086798|Procedure|Magill forceps|Magill forceps techniques to facilitate nasotracheal tube advancement into trachea
15973292|NCT03088059|Drug|IPH2201|protocol v2.0 and 2.1 : Monalizumab 10mg/kg given intravenously over 60 minutes, once every 14 days, 1 cycle is 14 days protocol v4.0 : Monalizumab 750mg given intravenously over 60 minutes, once every 28 days, 1 cycle is 28 days
15973293|NCT03088059|Drug|Durvalumab|Durvalumab 1500mg given intravenously over 60 minutes, once every 28 days, 1 cycle is 28 days
15973294|NCT03088059|Drug|Niraparib|Niraparib 300 mg given orally, once daily, 1 cycle is 28 days
15973295|NCT03088059|Drug|BAY1163877|Rogaratinib 600 mg given orally, twice daily, 1 cycle is 28 days
15973296|NCT03088046|Drug|Micronized Progesterone|"Anovulatory women with Polycystic ovary syndrome and clinical hyperandrogenism attended in our Hospital will participate in the study. A patient information sheet will be provided and written consent will be obtained. Patients who give written consent will participate in the trial. All patient information will be confidential and only be available to researches involved in the study.
~Blood samples will be collected at baseline (Sample #1) and between the 3rd and the 5th day of withdrawal after 7 days of 100mg vaginal MP every 12 hours of administration(Sample#2)."
15973297|NCT03088033|Device|IASD System II implant|The primary component of the system is an implant placed in the atrial septum designed to allow left to right flow between the left atrium and right atrium to reduce the elevated left atrial pressure.
15973298|NCT03088033|Other|intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE)|intra-cardiac echocardiography (ICE), or transesophageal echocardiography (TEE) for examination of the atrial septum and left atrium.
15973299|NCT03088007|Other|Cognitive, adaptive, behavioral and academic assessment|Cognitive, adaptive, behavioral and academic assessment will be performed if not available in the records, using WISC-IV, VABS, GECEN and an academic skills rating form.
15973300|NCT03087994|Behavioral|Nutritional guidance intervention|participants in this group will attend 12 meeting of nutritional guidance
15973301|NCT03087994|Behavioral|Nutritional guidance intervention|Participants in this group will only receive nutrition guidance once during the study
15973302|NCT03087968|Drug|GS-4997|Experimental drug
15973303|NCT03087968|Drug|Prednisolone|Control drug that is also administered with the Experimental drug, GS-4997. This drug is used in both arms.
15973304|NCT03087968|Device|HepQuant SHUNT Test|"The HepQuant SHUNT Liver Diagnostic Kit is intended for use in the quantitative detection of 13C-cholate and d4-cholate in blood serum, collected after the intravenous administration of 13C-cholate and the oral ingestion of d4-cholate. The device is indicated to assess the severity of liver disease.
~For use by health care professionals. Administer the test under a physician's supervision. The HepQuant Analytical Testing Laboratory must analyze the serum samples."
15973305|NCT03087968|Drug|Placebo|Placebo
15973306|NCT03087955|Drug|Acoziborole (SCYX-7158)|
15973307|NCT03087942|Drug|QAW039|450 mg
15973308|NCT03087942|Drug|QAW39A|450 mg
15973309|NCT03087942|Drug|QAW39A2107|450 mg
15973310|NCT03087942|Drug|QAW39A2107|450 mg
15973311|NCT03087929|Other|Follow up|
15973312|NCT03087903|Dietary Supplement|Grape Seed Extract|Patients will take 150 mg of Grape Seed Extract (GSE) product by mouth twice daily (in the form of 75 mg capsule of Leucoselect Phytosome preparation). Total oral dosage is 300 mg of GSE per day for one year. Patients will be evaluated every 6 weeks for 3 months, then every 3 months thereafter for up to one year. PSA measurements will be obtained at these scheduled visits.
15973313|NCT03087890|Drug|Cotrimoxazole|Patients will receive preventive treatment with 2 tablets cotrimoxazole (80 mg trimethoprim, 400mg sulfamethoxazole) daily for 48 weeks
15973314|NCT03087890|Drug|Placebo|Patients will receive 2 tablets placebo daily for 48 weeks
15973315|NCT03087877|Device|Acetaminophen Challenge (G6 CGM)|Evaluation of acetaminophen effect on CGM glucose sensing
15973316|NCT03087864|Drug|Atezolizumab|Atezolizumab 1200 mg i.v. day 1-22-43-64-85
15973317|NCT03087864|Drug|Carboplatin|Chemotherapy
15973318|NCT03087864|Drug|Paclitaxel|Chemotherapy
15973319|NCT03087864|Radiation|Radiotherapy 23 x 1.8 Gy|Radiotherapy
15973320|NCT03087851|Drug|Zoledronic Acid|Intravenous infusion of 5 mg zoledronic acid
15973321|NCT03087825|Procedure|preoxygenation without inward leak|breathing a 100% inspired oxygen gas flow during 3 to 10 minutes
15973322|NCT03087825|Procedure|preoxygenation with inward leak|breathing a 100% inspired oxygen gas flow during 3 to 10 minutes with an inward air leak made possible through a specific calibrated piece on the inspiratory branch
15973323|NCT03087799|Behavioral|Brief Behavioral Treatment for Sleep|The BBT arm will consist of 2 in-person treatment visits and 2 telephone check-in visits. Treatment will involve psychoeducation about sleep hygiene and stimulus control as well as sleep schedule modification and sleep restriction. The treatment manual is attached for clarification. This manual is used solely to guide clinical decision making and will not be provided to participants.
15973324|NCT03087786|Drug|Nicotine Bitartrate Lozenge 4mg|Test Product
15973325|NCT03087786|Drug|Nicotine Polacrilex 4Mg Lozenge|Active Comparator
15973326|NCT03087773|Drug|Empagliflozin 10 mg|The subject will receive Empagliflozin 10 mg orally once daily for 26 weeks.
15973327|NCT03087773|Drug|Placebo Oral Tablet|The subject will receive Placebo orally once daily for 26 weeks.
15973328|NCT03087760|Drug|Pembrolizumab|Concurrent Pembrolizumab after proton reirradiation
15973329|NCT03087747|Procedure|Percutaneous cholecystostomy|Placement of drainage catheter into gallbladder lumen in order to evacuate inflamed content.
15973330|NCT03087734|Device|Implantation of new model of bar with oblique stabilizers|Implantation of new model of bar with oblique stabilizers
15973331|NCT03087734|Device|Implantation of regular bar with perpendicular stabilizers|Implantation of regular bar with perpendicular stabilizers
15973332|NCT03087721|Behavioral|HIIT-LV|"Supervised endurance treadmill training as walking/running uphill, 3 times/week during 12 weeks starting at 85-90% of previously determined maximum oxygen consumption (VO2 max). Warm-up 3 min at 30% of VO2 max, 3 min cool-down. Progression in intensity every 3erd week."
15973333|NCT03087721|Behavioral|CAE|Supervised moderate intensity treadmill training, 3 times/week for 12 weeks starting at 70% of VO2 max. Warm-up 3 min at 30% of VO2 max, 3 min cool-down. Progression in intensity every 3erd week.
15973334|NCT03087708|Drug|Naloxegol|Given PO
15973335|NCT03087708|Other|Placebo|Given PO
15973336|NCT03087708|Other|Laboratory Biomarker Analysis|Correlative studies
15973338|NCT03087695|Diagnostic Test|Plasma EBV DNA|Parameters analyzed will include (1) the change pattern of plasma EBV DNA concentrations, (2) various half-life values (t1/2) of plasma EBV DNA clearance rate calculated over different time periods.
15973339|NCT03087682|Diagnostic Test|Optical Coherence Tomography (OCT)|OCT is used to measure thickness (numbers) of retinal nerve fibres in different areas of the retina
15973340|NCT03087669|Device|LVAD flow velocity setting-Rounds per Minute(RPM) on HeartMate III®|Increase in LVAD RPM setting induces an actual increase in LVAD outflow to the patient.This gives the patient an increased systemic Cardiac Output(CO)
15973341|NCT03087669|Drug|MAP intervention using Noradrenalin|At a fixed RPM rate for the LVAD the Mean Arterial Pressure (MAP) is increased to preset levels of 60-70-80-90 mmHG using Noradrenalin
15973342|NCT03087656|Drug|Ceftriaxone|Intravenous Ceftriaxone will be given during the procedure.
15973343|NCT03087656|Drug|Levofloxacin|Oral Levofloxacin will be given for 3 days after the procedure.
15973344|NCT03087643|Other|Passive mobilization - PM|
15973345|NCT03087630|Behavioral|Reasoned-Based Intervention|Receives personalized feedback based on the reasoned pathway of the Prototype Willingness Model.
15973346|NCT03087630|Behavioral|Social-Based Intervention|Receives personalized feedback based on the social pathway of the Prototype Willingness Model.
15973347|NCT03087630|Behavioral|Integrated Intervention|Receives personalized feedback based on both the reasoned and social pathways of the Prototype Willingness Model.
15973348|NCT03087630|Behavioral|Attention Control|Receives personalized feedback related to nutrition and exercise, unrelated to drinking behavior.
15973349|NCT03087617|Device|Imbio Smoking Cessation Report|Research coordinators at the University of Michigan and HealthPartners will be provided access to the research version of LDA via an Imbio website. Following consent and lung screen, research coordinators will manually upload the study participants' images and download a resulting Report. Radiologists have been designated at both sites to review and approve the Report prior to mailing to participants. The Report will include information including the percent of damaged lung volume.
15973350|NCT03087617|Behavioral|Smoking Cessation Counseling|45 minute counseling session with a tobacco treatment specialist.
15973351|NCT03087617|Other|Usual Care|Usual Care for Lung Cancer Screening patients.
15973352|NCT03087604|Procedure|Thoracic epidural block|Thoracic epidural block with epidural placed with a loss of resistance technique alone.
15973353|NCT03087604|Procedure|Electrical Nerve stimulation|In the electrical stimulation group, following the location of the epidural space with a loss of resistance technique (using air), nerve stimulation will be utilized to elicit a myotomal contraction of the abdominal or thoracic wall.stimulating peripheral nerve catheters(19 Ga. x 90 cm StimuCath® Continuous Nerve Block Catheter with SnapLock™ Adapter (Arrow by Teleflex Medical, Morrisville, NC), and stimulation will be achieved using a B Braun Stimuplex HNS12 Nerve Stimulator product id 4892098.
15973354|NCT03087604|Drug|Solution For Thoracic epidural block|Dose of 3+2 ml of 1.5% lidocaine with 1:200,000 epinephrine
15973355|NCT03087591|Other|Laboratory Biomarker Analysis|Correlative studies
15973356|NCT03087591|Biological|siRNA-transfected Peripheral Blood Mononuclear Cells APN401|Given IV
15973357|NCT03087578|Other|electroacupncture|Patients will receive electroacupuncture treatment for 30 minutes per weekly session for 6 weeks.
15973358|NCT03087578|Drug|Mirabegron 50 MG [Myrbetriq]|Patients will receive 50 mg of mirabegron daily for 6 weeks.
15973359|NCT03087565|Procedure|subtotal hystrectomy|"A transverse lower abdominal incision (Pfannenstiel incision) The corpus is amputated just below the level of the isthmus and then the endocervical canal is electrocoagulated using monopolar electrocautery. The cervical stump is closed using vicryl 0 sutures.
~Revision of all pedicles to ensure hemostasis. Intraoperative antibiotics . The abdomen is closed in layers; the wound is covered with a sterile dressing."
15973360|NCT03087565|Procedure|Total hystrectomy|"A transverse lower abdominal incision (Pfannenstiel incision) The urinary bladder is dissected off the lower uterine segment of the uterus and cervix by blunt or sharp dissection. Revision of all pedicles to ensure hemostasis.
~The abdomen is closed in layers; the wound is covered with a sterile dressing."
15973361|NCT03087552|Procedure|Transradial balloon aortic valvuloplasty|Mini-invasive balloon aortic valvuloplasty consisting in transradial access
15973362|NCT03087552|Procedure|Transradial balloon aortic valvuloplasty|Rapid pacing using the 0.035-in. retrograde left ventricular support wire
15973363|NCT03087539|Biological|Abciximab|
15973364|NCT03087539|Biological|Placebo|
15973365|NCT03087526|Genetic|Non invasive prenatal diagnosis|Search for the familial mutation on isolated circulating fetal trophoblastic cells from maternal blood
15973366|NCT03087513|Drug|Sugammadex Injection [Bridion]|The study participants will receive 10 ml syringe containing Sugammadex (2mg/kg) in the first phase followed by Placebo 10 ml syringe containing of 0.9% of normal saline in the second phase.
15973367|NCT03087513|Drug|Placebo|The study participants will receive Placebo 10 ml syringe containing of 0.9% of normal saline in the first phase followed by 10 ml syringe containing Sugammadex (2mg/kg) in the second phase.
15973368|NCT03087474|Other|Non-Interventional|Non-Interventional
15973369|NCT03087461|Behavioral|Exercise and self-management|The intervention will include aerobic exercise and self-management education using technology.
15973370|NCT03087448|Drug|Ceritinib|"ALK tyrosine inhibitor, 300 mg - 450 mg PO daily.
~Phase I dose escalation:
~Ceritinib 300mg
~Ceritinib 450mg
~Ceritinib 450mg
~The Phase II doses will be determined by Phase I dose escalation study"
15973371|NCT03087448|Drug|Trametinib|"MEK kinase inhibitor, 1.5 mg - 2.0 mg PO daily.
~Phase I dose escalation:
~Trametinib 1.5mg
~Trametinib 1.5mg
~Trametinib 2.0mg
~The Phase II doses will be determined by Phase I dose escalation study"
15973372|NCT03087435|Device|Well-Being questionnaire|Development and validation of a tool to access residents well-being.
15973373|NCT03087422|Behavioral|Text message intervention|The intervention consists in sending text messages with orientation that helps in homecare, specifically attempting to minimize chemotherapy side effects.
15973374|NCT03087396|Device|Treatment of insufficiency fractures|Filling of micro fractures or insufficiency fractures with a bone substitute material
15973375|NCT03087370|Other|No intervention|No intervention
15973376|NCT03087357|Other|SmartNIPT|A novel, non-next generation sequencing (NGS) test that is designed to perform as well as conventional NGS screening while being simpler and less expensive.
15973377|NCT03087344|Device|Fibroscan and Acoustic Radiation Force Impulse|Liver stiffness and spleen stiffness will be measured before and after a standard meal is administered by Fibroscan and Acoustic Radiation Force Impulse
15973378|NCT03087344|Device|Fibroscan|Liver stiffness will be measured before and after a standard meal is administered
15973379|NCT03087344|Device|Acoustic Radiation Force Impulse|Liver stiffness and spleen stiffness will be measured before and after a standard meal is administered by Fibroscan and Acoustic Radiation Force Impulse
15973380|NCT03087331|Other|medication reviews, assessment, recommendations, education.|
15973381|NCT03087318|Behavioral|Physical activity|"Physical activity:
~3 sessions / week at least
~at least during 30 minutes each session
~at least at 50% of the maximal heart rate measured during the exercise stress testing (from the screening)
~during 3 months."
15973382|NCT03087305|Diagnostic Test|Supraclavicular lymph node ultrasound|Patients will have supraclavicular lymph node assessed prior to EBUS-TBNA
15973383|NCT03087292|Other|Resistance training with vascular occlusion|Patients will perform unilateral leg extension resistance training with vascular occlusion 2 times per week for a period of 8 weeks. Each training session will consist of 3 sets of 15 repetitions at the intensity of 30% 1 RM with 30 s of rest period between sets.
15973384|NCT03087279|Behavioral|Texas I-CAN!|physically active, academic lessons in the elementary school classroom
15973385|NCT03087266|Procedure|FM-SRP|Non surgical periodontal treatment performed in all dentition within 1-2 appointments in a 24 hour time frame.
15973386|NCT03087266|Procedure|Q-SRP|Non surgical periodontal treatment performed in 4 sessions comprising of a quadrant (1/4) of the dentition each. Performed in 3 weeks time frame.
15973387|NCT03087240|Procedure|Dental Prophylaxis|Prevention and treatment of periodontal diseases by cleaning of the teeth in the dental office using the procedures of dental scaling and dental polishing. The treatment includes plaque detection, removal of supra- and subgingival plaque and calculus, as well as motivation and demonstration for establishing a sufficient oral hygiene.
15973388|NCT03087227|Device|NEUTROSIS|evaluate a shared health information system (NEUTROSIS) for home-hospital management of febrile neutropenia after anti-tumor chemotherapy
15973389|NCT03087201|Drug|nabiximols|"starting dose (1 puff): 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD), maximum dose (12 puffs): 32.4 mg THC/30 mg CBD, no target dose is defined
~Duration of treatment: 13 weeks"
15973390|NCT03087201|Drug|placebo|analogous to experimental intervention
15973391|NCT03087188|Other|Utilization of inhalator|"After written consent patients will be asked whether they know how to use the inhalator and for how long therapy has been already conducted. Patients using the inhalator correctly have completed the study at this point. If patients have demonstrated incorrect use of the inhalator, a film sequence with instructions will be shown via a tablet. The learning success will be assessed subsequently. When patients show correct application, they will be asked to come back for a follow-up visit within 2 to 8 weeks, otherwise they will be retrained by study staff. At the follow-up visit another demonstration evaluation will be performed.
~While demonstrating patients will use the inhalator without any drug that could have any medicinal effect on them."
15973392|NCT03087175|Device|MGuard stent|MGuard micronet mesh-covered stent in treatment of STE and NSTE-ACS
15973393|NCT03087175|Device|Drug eluting stent and bare metal stent|Drug eluting stent and bare metal stent in treatment of STE and NSTE-ACS For example, Resolute Onyx
15973394|NCT03087162|Drug|Dexlansoprazole 60 mg once daily|Once daily dose dexlansoprazole(Dexlansoprazole(60) OD) in experimental arm and Twice daily dose dexlansoprazole(Dexlansoprazole(60) 1 BID) in active arm
15973395|NCT03087149|Dietary Supplement|monitored vit D supplementation|The vit D supplementation dose start from dose 500IU from 7th day of age and is modified based on vit D measurement at 4 week of age for infants born <30 GA, at 8 week of age for infants born <26 GA at 35+/-2 weeks PMA(postmenstrual age), +/-at 40+/-2 weeks PMA according to the protocol.
15973396|NCT03087149|Dietary Supplement|standard vit D supplementation|The vitamin D supplementation dose is 500IU from 7th day of age.
15973397|NCT03087136|Diagnostic Test|anti-aquaporin-4 antibody|Serum anti-aquaporin-4 antibody
15973398|NCT03087136|Diagnostic Test|anti-myelin oligodendrocyte glycoprotein|Serum anti-myelin oligodendrocyte glycoprotein
15973399|NCT03087123|Behavioral|P-Mobile App|The behavioral strategies are based on Social Cognitive Theory. The following topics will be covered: self-monitoring, goal setting, stimulus control, making time for exercise, exercising in- and outdoors, problem-solving, reinforcing PA, reducing sedentary behaviors, relapse prevention, parental modeling, lifestyle exercise, self-efficacy, self-management, parental PA modeling, parental co-participation, and establishing PA rules. Parents will be provided with adapted step goals (based on principles of shaping). Text messages will be designed to prompt PA, remind parents of concepts from the lessons, and motivate behavioral change.
15973400|NCT03087110|Biological|Matched sibling donor cord blood cell infusion|Single dose intravenous infusion of 12/12 HLA matched sibling donor cord blood cells (>1x10^7 cells/kg)
15973401|NCT03087097|Biological|Fecal Microbiota Transplantation|Fecal microbiota delivered by rectal catheter enema in participants 12-60 months of age with malnutrition (MAM or SAM) who are in the rehabilitation phase of treatment and have failed to respond to at least 4 weeks of standard therapy.
15973402|NCT03087084|Device|Cardiac Pacing and Impedance Measurement system|Subjects indicated for Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy Defibrillator device implant will be requested to perform some respiratory manoeuvres while impedance and electrogram signals are recorded by the system
15973403|NCT03087071|Other|Laboratory Biomarker Analysis|Correlative studies
15973404|NCT03087071|Biological|Panitumumab|Given IV
15973405|NCT03087071|Drug|Trametinib|Given PO
15973406|NCT03087058|Drug|Patiromer|4.2 g/day, 8.4 g/day and 16.8 g/day
15973407|NCT03087058|Drug|Patiromer|2 g/day, 4 g/day and 8 g/day
15973408|NCT03087058|Drug|Patiromer|1 g/day, 2 g/day and 4 g/day
15973409|NCT03087032|Drug|Liraglutide|Patients will receive adding Liraglutide to prandial insulin Lispro. The starting liraglutide dose was 0.6mg/day, then 1.2mg/day after 1 week and 1.8mg/day after a further week. The dose was maintained until study completion. Dose of insulin Lispro will be instructed on a titration schedule, adjusted every 3 days.
15973438|NCT03086798|Procedure|cuff inflation|cuff inflation techniques to facilitate nasotracheal tube advancement into trachea
15973410|NCT03087032|Drug|insulin glargine|Individuals randomized to adding insulin Glargine to prandial insulin Lispro will be instructed on a titration schedule, adjusted every 3 days. Patients subcutaneously self-injected once-daily at approximately the same time each day.
15973411|NCT03087019|Radiation|Radiation|Standard use of radiation is administered
15973412|NCT03087019|Drug|Pembrolizumab|Pembrolizumab is designed to restore the natural ability of the immune system to recognize and target cancer cells.
15973413|NCT03087006|Other|Automatic Self Transcending Meditation (ASTM)|Automatic Self Transcending Meditation (ASTM) is a class of meditation that helps quiet the mind. Research suggests that ASTM helps reduce depression, anxiety, stress, and may improve health related quality of life. Further, ASTM is easier to learn and to teach.
15973414|NCT03087006|Other|Treatment as Usual|Usual Care includes usual care of the participants including dry eye disease medications
15973415|NCT03086993|Combination Product|Melphalan/HDS|Melphalan/HDS treatment for up to six cycles, followed by a re-induction of CisGem.
15973416|NCT03086993|Drug|Cisplatin and Gemcitabine|continuous treatment with Cis/Gem until disease progression
15973417|NCT03086980|Other|Automatic Self Transcending Meditation|Automatic Self Transcending Meditation (ASTM) is a class of meditation that helps quiet the mind. Research suggests that ASTM helps reduce depression, anxiety, stress, and may improve health related quality of life. Further, ASTM is easier to learn and to teach.
15973418|NCT03086980|Other|Treatment as Usual|Usual Care will be provided.
15973419|NCT03086967|Device|Double-lumen balloon catheter|introduction of catheter into cervix for ripening prior to induction of labor following standard of care practices
15973420|NCT03086954|Biological|The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T)|This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-CD19-modified T cells can recognize and kill tumor cells in the body，follow-up 35 months.
15973421|NCT03086941|Device|I-gel|To compare between use of I-gel as a conduit for blind intubation and as a conduit for fiberoptic guided intubation in children. We also aim to validate the use of I-gel as conduit for blind intubation in absence of fiberoptic or lack of experience of its use.
15973422|NCT03086928|Other|lava ultimate|resin nano ceramic material
15973423|NCT03086928|Other|E.max cad|Lithium disilicate glass ceramic
15973424|NCT03086915|Drug|Neuromuscular Blocking Agent|Administration of neuromuscular blockers during anesthesia
15973425|NCT03086902|Device|Radiofrequency Ablation Catheter|Ablation of PVC with RF energy
15973426|NCT03086902|Device|Cryo Ablation catheter|Ablation pf PVC with Cryo enerygy
15973427|NCT03086889|Other|immersion virtual reality (VR)-based rehabilitation|Intervention group received VR-based rehabilitation,including Virtual kitchen and so on.The patients took part in the exercise program for 30 minutes each day, five times per week, for 3 weeks. All subjects received physiotherapy, which accounts for an average of 30 minutes of physiotherapy per day on tolerance.
15973428|NCT03086889|Other|traditional rehabilitation training|The traditional rehabilitation training included occupational therapy and physical therapy, patients took part in the traditional rehabilitation training for 60 minutes each day, five times per week, for 3 weeks.
15973429|NCT03086876|Behavioral|Level 4 Stepping Stones Triple P (SSTP)|Stepping Stones Triple P is a system of psychoeducational and behavioural approaches to parenting a child with LD and challenging behaviour that aims to increase parental confidence and skills so that parents are able to manage the child's behavior effectively. SSTP comprises different levels based on increasing family complexity.
15973430|NCT03086863|Device|electroacupuncture|All the patients in verum electroacupuncture group will receive acupuncture on the six adjacent acupoints (LI4, LI15, TE14, SI9, SI11, and GB21) in unilateral side. Acupuncture needles (stainless steel, 0.25 mm × 40 mm, Dong Bang Acupuncture Inc., Republic of Korea) will be inserted 10-15 mm in depth and de qi sensation will be elicited. Park sham guide tubes will be used in verum group, too. Low frequency stimulate (STN-111, Stratek, Republic of Korea) will be connected to the tips of needles to provide electrical stimulation at middle frequency (30 Hz). Needles with electrical stimulation will be retained for 20 minutes. Patients should take this procedure 3 times a week for 3 weeks (9 sessions in total).
15973431|NCT03086863|Device|sham electroacupuncture|We selected a non-penetrating sham needling, i.e., Park sham device, which has been developed and validated in preceding studies as comparison. On the exactly same 6 acupoints as verum electroacupuncture group, needles will be installed with Park sham guide tubes and the same electrical stimulators will be connected the tips of needles. Since the needles do not penetrate the skin, the stimulation is not electrically conducted. To be sure of patient blinding, the low frequency stimulate will be turned on with the same frequency (30 Hz), which makes a fake noise, resulting in letting patients believe that they are taking real electroacupuncture therapy for 20 minutes. Sham group will also 9 session for 3 weeks (3 sessions a week).
15973432|NCT03086850|Behavioral|Promotion of daily physical activity with a pedometer|"Patients will receive an ONwalk 100 pedometer (GEONAUTE, France) and will be instructed how to use it. They will be encouraged to be more active by using the pedometer to measure the number of steps walked daily and to record this in a diary, together with any information related to their clinical condition. Based on the cumulative step count for each day and the mean value since the last visit, patients will receive a task to increase their steps per day by the next appointment according to the next protocol:
~<6000 steps/day: increase by 3000 steps/day
~6000 - 10000 steps/day: reach 10000 steps/day
~> 10000 steps/day: maintain or increase steps"
15973433|NCT03086850|Other|Conventional treatment|Treatment and follow-up according to conventional clinical practice (SEPAR guidelines), including standard recommendations on healthy habits and lifestyle.
15973434|NCT03086837|Behavioral|Mobile phone based intervention|Participants will receive supporting messages through a mobile phone based intervention.
15973435|NCT03086824|Device|magnetic resonance-guided focused ultrasound|
15973436|NCT03086811|Behavioral|Mother Infant Feeding Interaction very early training|"weekly training meetings on 4 topics:
~What - proper nutrition and supplements for solid feeding phase (dietitian); What - the meaning of feeding to mother and infant (social worker).
~Who - feeding skills - knowledge and actual practices
~From anxiety to serenity - knowledge concerning growth patterns and common physical and emotional issues troubling parents of infants 4-12 months old.
~Prevention of obesity and emotional eating - practical advise and tips."
15973439|NCT03086785|Drug|Apatinib|apatinib 500mg qd po or combined capecitabine 1000mg/m2 bid d1-14 q3w
15973440|NCT03086772|Behavioral|Tai Chi|Individuals in the Tai Chi intervention group will participate in a 12-week Tai Chi program (one hour per class, two classes per week, plus home practice for 12 weeks) led by an experienced Tai Chi Instructor, assisted by an undergraduate research assistant.
15973441|NCT03086772|Behavioral|Light Exercise|Individuals in the exercise control group will meet for a twice weekly class involving walking, weight training, stretching and health education (one hour per class, two classes per week for 12 weeks, taught by a trained graduate research assistant, assisted by an undergraduate research assistant.
15973442|NCT03086759|Procedure|platelet rich plasm|intra-articular infiltration with platelet rich plasm
15973443|NCT03086759|Drug|Triamcinolone Hexacetonide|intra-articular infiltration withTriamcinolone Hexacetonide
15973444|NCT03086759|Procedure|Isotonic Saline Solution|intra-articular infiltration with Isotonic Saline Solution
15973445|NCT03086733|Drug|Metformin|850 mg tablets v/o OD for first 5 days 850 mg tablets v/o BID until day 21
15973446|NCT03086720|Procedure|Sodium hypochlorite|Application of 10% sodium hypochlorite (60 seconds) after the etching procedure and before the adhesive system.
15973447|NCT03086720|Procedure|Water|Treatment of acid etched dentin with sterilized water for 60 s before adhesive system application
15973448|NCT03086707|Other|Cigarette|After enrollment, and between Visit 2 and Visit 3, the subjects will abstain from smoking for a period of 8 hours. At Visit 3, after the 8-hour smoking abstinence period, the subjects will smoke 1 single cigarette.
15973449|NCT03086681|Drug|Endostar|Endostar: 7.5mg/m2 d1-10, repeat every 15 days, for 4 cycles
15973450|NCT03086681|Drug|DDP|DDP: 40mg /m2，per week, for 5 cycles
15973451|NCT03086668|Procedure|Conventional Jaw thrust Group|a video-stylet assisted nasotracheal intubation and facilitate by conventional jaw thrust technique
15973452|NCT03086668|Procedure|Fingers hook Group|a video-stylet assisted nasotracheal intubation and facilitate by fingers-hook technique
15973453|NCT03086655|Behavioral|Tel-me-box with reminder features|Participants will meet with a study staff member to go over their daily routines, including their pill taking schedule, and to work out a plan for tailored reminders. The participant will choose from the reminders available and convey their preferences regarding when reminders should be sent for the TMB. Preferences will be stored in an online secure database. If requested by the participant, the reminder schedule and type of reminder can be reprogrammed by study staff via an online portal. When the reminder is reprogrammed the TMB receives a new configuration SMS to update the device reminder settings.
15973454|NCT03086655|Behavioral|Tel-me-box|Participants receive tel-me-box device with no reminder features added.
15973455|NCT03086642|Drug|Talimogene laherparepvec|"T-Vec will be administered by intratumoral injection into pancreatic tumors accessible endoscopically with ultrasound guidance (at least one pancreatic lesion must be injected during each treatment).
~On day 1 of week 1 the first dose of talimogene laherparepvec will be up to 4.0 mL of 10^6 PFU/mL. The second injection up to 4.0 mL of 10^6, 10^7, or 10^8 PFU/mL should be administered no sooner than day 1 of week 4 but should not be delayed more than 7 days after the scheduled time point. The maximum volume of T-Vec administered at any one time is 4.0 mL for any individual lesion."
15973456|NCT03086629|Other|Patient Concerns Inventory|
15973457|NCT03086629|Other|No Patient Concerns Inventory|
15973458|NCT03086616|Drug|Convection Enhanced Delivery (CED) of Nanoliposomal irinotecan (nal-IRI)|Nal-IRI will be given directly into the tumor using CED.
15973459|NCT03086564|Biological|ADCC & TACE|Experimental groups will be given TACE as well as Activated-Dendritic Cells(1-2*10^8,intravenous drip),simultaneously.Cyclophosphamide(250mg/cm2,intravenous drip) will be used two days before TACE performed.
15973460|NCT03086564|Procedure|TACE|TACE solely in the first day of a clinical course.
15973461|NCT03086551|Device|Active continuous theta burst stimulation (cTBS)|Active cTBS over dorsolateral prefrontal cortex that has an effect upon dorsolateral prefrontal cortex brain activity.
15973462|NCT03086551|Device|Placebo (Sham) continuous theta burst stimulation|Sham stimulation over dorsolateral prefrontal cortex that looks and sounds like active cTBS but does not have any effect upon dorsolateral prefrontal cortex brain activity.
15973463|NCT03086551|Behavioral|Motor Practice|Upper limb reaching task to be practiced. Practice will be paired with Active/Sham stimulation. Twenty trials will occur before Active/Sham stimulation. 40 trials will be practiced after Active/Sham stimulation.
15973464|NCT03086538|Drug|Pemetrexed|Pemetrexed is a multitarget antifolate (MTA) whose mechanism of action relies mainly on the inhibition of TS, with weaker secondary effects on glycinamide ribonucleotide formyltransferase (GARFT) and dihydrofolate reductase (DHFR), leading to impairment of DNA synthesis and repair.
15973465|NCT03086538|Drug|Tarceva 100Mg Tablet|Erlotinib (tarceva) is oral epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI).
15973466|NCT03086525|Other|Diagnosis/Prognosis|The present study will be a prospective observational study of 4 years that will be carried out between September 2017 and September 2020 at the University of Malaga. Several questionnaires assessing different beliefs associated with pain will be administered to participants. The results will be evaluated at baseline (t1) and in 4 follow-ups (at 12 (t2), 24 (t3), 36 (t4) and 48 (t5) months.
15973467|NCT03086512|Device|Acutrak 2® - 7.5 Screw|"The Acumed Acutrak 2® - 7.5 is a fully-threaded headless screw fixation, composed of 17 unique screw size options. The Acutrak 2® - 7.5 is available in sizes from 40 mm to 120 mm and is inserted using a 4.0 mm hex driver over a .094 guide wire. The Acutrak 2 Part Number is 30-0XXX and 30-0XXX-S."
15973468|NCT03086512|Device|Synthes® 7.3 Cannulated Screw|The Synthes® 7.3 mm Cannulated screws are available in three thread options: 16 mm, 32 mm or fully threaded. This study will use the partially threaded options. The screws can be placed by small diameter guide wires. They are composed of 316L stainless steel or titanium alloy (Ti-6Al-7Nb).
15973469|NCT03086486|Drug|Pretomanid|200mg tablets
15973470|NCT03086486|Drug|Linezolid|Scored 600mg tablets
15973471|NCT03086486|Drug|Bedaquiline|100mg tablets
15973472|NCT03086486|Drug|Placebo Linezolid|Scored 600 mg tablets
15973473|NCT03086473|Drug|Caffeine Citrate|The intervention in this study is timing of the initial caffeine dose. In the Caffeine arm, participants will receive Caffeine Citrate 20mg/kg IV (volume dose 1ml/kg) within 2 hours of life, and Normal Saline (0.9% NaCl) 1ml/kg IV at 12 hours of life.
15973547|NCT03085953|Other|Waitlist Control|Control group will receive training following all measurements points to serve as a comparison group
15973474|NCT03086473|Drug|Placebo (Normal Saline)|The intervention in this study is timing of the initial caffeine dose. In the Placebo arm, participants will receive Normal Saline (0.9%NaCl) 1ml/kg IV within 2 hours of life, and Caffeine Citrate 20mg/kg IV (volume dose 1ml/kg) at 12 hours of life.
15973475|NCT03086460|Drug|CHF 1531 pMDI|Dose Response: Test one of five different doses of CHF 1531
15973476|NCT03086460|Drug|Formoterol Inhalation Solution|Active Control
15973477|NCT03086460|Drug|Placebo pMDI|Matched Placebo
15973478|NCT03086447|Device|Investigational Contact Lens|Senofilcon C Toric
15973479|NCT03086447|Device|Marketed Contact Lens|Air Optix for Astigmatism
15973480|NCT03086434|Other|Culturally Tailored Intervention|School-based substance use prevention
15973481|NCT03086434|Other|Standard Substance Abuse Education|Class room program
15973482|NCT03086421|Behavioral|Questionnaires|Participants, their parent/legal guardian, and if consented to another adult caregiver will be asked to complete several questionnaires evaluating the participant's social cognitive skills, social experience, neurocognitive functioning, and neurocognitive skills.
15973483|NCT03086408|Device|THRIVE|active nasal oxygen delivery system
15973484|NCT03086408|Device|Endotracheal tube or Supraglottic airway|Plastic devices for mechanical ventilation
15973485|NCT03086395|Drug|Obinutuzumab|Patients will be treated with a total of 2 cycles of obinutuzumab. Cycle 1 obinutuzumab dose is 1000 mg given intravenously (IV) on day 1, 8, 15. Cycle #1 day #1 dose of 1000 mg of obinutuzumab will be administered over 2 days. During Cycle 1, Day 1, 100 mg will be administered. On the following day (Cycle 1, Day 2), 900 mg will be administered. During cycle 2 patients will receive a single dose of obinutuzumab1000 mg IV on day 1. Cycle #2 will be given 21 days after the first cycle.
15973486|NCT03086382|Drug|Lacosamide (LCM) tablet|Treatment A: Single dose of Lacosamide (LCM) 200 mg given as 2 tablets of LCM 100 mg
15973487|NCT03086382|Drug|Lacosamide (LCM) syrup|Treatment B: Single dose of Lacosamide (LCM) 200 mg given as syrup
15973488|NCT03086369|Drug|Olaratumab|Administered IV
15973489|NCT03086369|Drug|Nab-paclitaxel|Administered IV
15973490|NCT03086369|Drug|Gemcitabine|Administered IV
15973491|NCT03086369|Drug|Placebo|Administered IV
15973492|NCT03086356|Drug|Dabigatran etexilate|Days 1-4 and Day 8-11
15973493|NCT03086356|Drug|Idarucizumab|Day 11
15973494|NCT03086343|Drug|Abatacept|IV infusion
15973495|NCT03086343|Drug|Placebo for abatacept|IV infusion
15973496|NCT03086343|Drug|Upadacitinib|15 mg extended release tablet
15973497|NCT03086343|Drug|Placebo for upadacitinib|Film-coated tablet
15973498|NCT03086330|Drug|Semaglutide|Semaglutide, gradually increased to 1.0 mg, injected once weekly under the skin (subcutaneously, s.c.) for 30 weeks
15973499|NCT03086330|Drug|Placebo|Semaglutide placebo, gradually increased to 1.0 mg, injected once weekly under the skin (subcutaneously, s.c.) for 30 weeks
15973500|NCT03086317|Device|Standard Catheter-Directed Thrombolysis|Catheter-directed thrombolysis requires placement of a multi-sidehole infusion catheter within the pulmonary arterial thrombus burden, under angiographic guidance. Thrombolytic medications are slowly infused through the catheter, which is left in place for the duration of the treatment. The treatment will be performed according to current standard of care and all technical considerations will be left to the discretion of the operator performing the procedure. All follow up is according to standard of care.
15973501|NCT03086317|Device|Ultrasound-Accelerated Thrombolysis|USAT is a modification of standard catheter-directed thrombolysis utilizing a proprietary system of local high frequency, low-power ultrasound to dissociate the fibrin matrix of the thrombus, allowing deeper penetration of lytic medication. The treatment will be performed according to current standard of care and all technical considerations will be left to the discretion of the operator performing the procedure. All follow up is according to standard of care.
15973502|NCT03086304|Device|transcutaneous acupoint electrical stimulation|Transcutaneous acupoint electrical stimulation is same to the traditional Chinese medicine acupuncture treatment,treat diseases by stimulate different acupuncture points.
15973503|NCT03086304|Device|no transcutaneous acupoint electrical stimulation|the choice of acupoints are same with TEAS group,tape over the electrode but don't give electroacupuncture stimulation.
15973504|NCT03086291|Drug|Simvastatin|Simvastatin 5-10mg/kg bid for 7 days and 14 days off treatment for 21 days
15973505|NCT03086278|Drug|AST-008|AST-008 is a toll-like receptor 9 agonist.
15973506|NCT03086265|Device|THRIVE|active nasal oxygen delivery system
15973507|NCT03086265|Device|Endotracheal tube|Plastic tube for supporting ventilation during surgery
15973508|NCT03086252|Procedure|Red Blood Cell Transfusions (RBCT)|Undergo patient-driven RBCT
15973509|NCT03086239|Drug|Rovalpituzumab tesirine|Intravenous
15973510|NCT03086226|Drug|Fosravuconazole|Fosravuconazole will be given in two arms either as 300mg or 200mg. The drop-the loser design adaptive clinical trial design will allow two stages of the trial separated by a data based decision. In the first stage a decision will be taken on which arm to drop either the Fosravuconazole 200 or the Fosravuconazole 300 arm. The best treatment will be compared against the standard of care, itraconazole. At the end the focus will be comparing the best treatment against standard of care.
15973511|NCT03086226|Drug|Itraconazole|This will be the active comparator
15973512|NCT03086213|Drug|Propofol|anaesthetic
15973513|NCT03086213|Drug|Sulfentanyl|anaesthetic
15973514|NCT03086213|Drug|Dexmedetomidine|anaesthetic
15973515|NCT03086213|Drug|Lidocaine|local anaesthetics
15973516|NCT03086213|Drug|Ropivacaine|local anaesthetics
15973517|NCT03086200|Behavioral|brief Motivational Interviewing|"All study participants will receive daily dosing text message reminders.
~Participants randomized to the MI-b Intervention and who are persistently non-adherence based on negative or non-responses to iTAB will be sent automated high alert messages notifying the participant to take their study medication and respond to iTAB. Both the study coordinator and the MI counselor will also receive the high alert message. Participants will be contacted by the MI counselor for a phone MI-b session within 72 hours of a high alert message to discuss adherence. Participants who continue to be non-adherent despite receiving these messages will be switched to receive alert messages on a monthly schedule."
15973518|NCT03086187|Device|Hephaistos unloading orthosis|The Hephaistos unloading orthosis greatly reduces plantarflexor muscle torque and plantarflexor muscle activation during any gait activity.
15973519|NCT03086174|Biological|humanized anti-PD-1 monoclonal antibody Toripalimab|humanized anti-PD-1 monoclonal antibody Toripalimab is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically.
15973520|NCT03086161|Behavioral|Interpersonal Psychotherapy|Six individual 1-hour sessions delivered over the course of pregnancy to address interpersonal problems areas that may lead to emotional eating, physical inactivity, and increased stress during pregnancy, which are drivers of excess weight gain in pregnancy
15973521|NCT03086161|Behavioral|Treatment-as-usual|Routine prenatal care as part of multidisciplinary adolescent pregnancy clinic, including medical (ob/gyn), nutrition, and social work
15973522|NCT03086148|Drug|Ketamine|Ketamine will be administrated intravenously at dural opening, with the total dose of 0.5 mg/kg and continual infusion for 40 minutes.
15973523|NCT03086148|Drug|Normal saline|Normal saline will be administrated intravenously at dural opening, with the total dose of 0.5 ml/kg and continual infusion for 40 minutes.
15973524|NCT03086135|Device|Osia System|An external Sound Processor captures and digitize the sound which is transferred to the internal implant where it is converted to an electrical signal. The electrical signal is further transferred as a vibration through an osseointegrated implant to the mastoid bone and eventually to the cochlea.
15973525|NCT03086122|Device|Continuous positive airway pressure|Continuous positive airway pressure treatment for patients randomized to CPAP treatment group. Treatment duration: 3 months.
15973526|NCT03086109|Other|Risk factors|Risk factors associated bone degenerative diseases
15973527|NCT03086096|Device|LifePearl Microspheres loaded with Irinotecan|LifePearl Microspheres are embolisation microspheres for transcatheter chemoembolisation (TACE), that can be loaded with chemotherapeutic agents. In this registry, LifePearl Microspheres will be loaded with Irinotecan.
15973528|NCT03086083|Behavioral|EMDR standard protocol|Patient have only one standard EMDR session about a traumatic situation remembered by him.
15973529|NCT03086083|Behavioral|protocol without brain stimulation|Patient have only one standard EMDR session about a traumatic situation remembered by him, however, without the bilateral brain stimulation.
15973530|NCT03086070|Drug|Omeprazole 20mg|omeprazole 20 mg capsules were administered per os half an hour before breakfast for 8 weeks
15973531|NCT03086070|Drug|Placebo oral capsule|Matching placebo oral capsules were administered per os half an hour before breakfast for 8 weeks
15973532|NCT03086057|Behavioral|PrEPare for Work: Strength Based Case Management (Stage 1)|Support, facilitate, and assist in linkage to PrEP clinic and to facilitate initiation of, and obtaining, PrEP medications.
15973533|NCT03086057|Behavioral|PrEPare for Work: Adherence Training and Counseling (Stage 2)|Up to three adherence training and counseling intervention sessions (once per week for two to three weeks) with a clinical interventionist.
15973534|NCT03086044|Drug|Sofosbuvir/velpatasvir|4 weeks of treatment beginning on the day of transplant or as soon as the recipient is able to tolerate oral medications after transplantation.
15973535|NCT03086044|Other|Monitoring|Close HCV viral load monitoring Will receive direct acting antiviral treatment with 6 weeks of sofosbuvir/velpatasvir if the recipient develops HCV viremia during the post-transplant HCV viral load testing
15973536|NCT03086031|Behavioral|Program -based vocational rehabilitation intervention|"The VR intervention lasts for a total of 6-9 months with first six different modules (3-month) that are individually planned, and second a work placement program (approximately 3-6 months). Each of the different modules follows a comprehensive standard operating procedures (SOP's). The six modules will be grouped into (a) individual therapies which includes neuropsychological sessions (10-hours), balance between work and everyday life (20-hours), and job matching (10-hours), (b) grouped-based therapies which includes psycho education (18-hours), mindfulness (15-hours), and physiotherapy training (15-hours), (c) an manualized family intervention program (8 sessions of 90 minutes), and an individual caregiver coaching (12-hours), (d) a work placement program including work practice (3-6 month), supported employment by the rehabilitation team (30-hours), and the development of a post rehabilitation plan (4-hours)."
15973537|NCT03086031|Behavioral|Conventional vocational rehabilitation (controls)|Treatment as usual delivered by the municipalities.
15973538|NCT03086018|Device|Successor hearing aid to Juna|The participants will all be experienced hearing instrument device users and will be switched from their current (control) devices to the new test device which succeeds the Juna device.
15973539|NCT03086005|Drug|Metformin|
15973540|NCT03085992|Drug|FOLFOXIRI plus Bevacizumab|"BEVACIZUMAB 5 mg/kg over 30 minutes, day 1
~IRINOTECAN 165 mg/sqm IV over 1-h, day 1
~OXALIPLATIN 85 mg/sqm IV over 2-h, day 1
~L-LEUCOVORIN 200 mg/sqm IV over 2-h, day 1
~5-FLUOROURACIL 3200 mg/sqm IV 48-h continuous infusion, starting on day 1 administered every two weeks for 6 cycles (3 months)."
15973541|NCT03085992|Other|Chemoradiotherapy plus Bevacizumab|"FLUOROURACIL 225 mg/sqm/day by protracted IV continuous infusion or -CAPECITABINE 825 mg/sqm/bid p.o. continuously without interruption for all the duration of radiation treatment;
~EXTERNAL-BEAM IRRADIATION 50.4 GY in 28 daily fractions over 5.5 weeks;
~BEVACIZUMAB 5 mg/kg over 30 minutes, starting on day 1 of radiation treatment day 1 and then every two weeks (for 3 cycles)."
15973542|NCT03085979|Procedure|Burch Colposuspension|Anti-incontinent surgery
15973543|NCT03085979|Procedure|trans obturator tape|Anti-incontinent surgery
15973544|NCT03085979|Procedure|tension free vaginal tape|Anti-incontinent surgery
15973545|NCT03085966|Biological|autologous immune cell therapy|Luteinizing Hormone Releasing Hormone Agonists (LHRH-a) and Autologous dendritic cells (DC) and central memory T cells (Tcm cells)
15973546|NCT03085953|Behavioral|Veteran Supportive Supervisor Training|"The family supportive supervisor behavior (FSSB) training intervention developed by Hammer and colleagues (2011) will be used as the basis for the development of the VSST intervention in the present study. In addition, we will draw on critical elements of training provided by the Employer Support of the Guard and Reserve (ESGR), information about potential mental and physical health effects of being in combat, and information to help reduce the stigma associated with returning veterans; in other words, de-clinicalizing their symptoms. Furthermore, this intervention study falls under the more general rubric of soldier resilience, but more specifically addresses both veteran and family resilience upon return from combat. The details of the training content will be researched and developed during the funded project period."
15973550|NCT03085927|Behavioral|Active Music Engagement|Three 45-minute sessions with a board-certified music therapist delivered over three days. Sessions are delivered in a private setting during in-patient hospitalization. During the first visit, parent and child will receive information on common responses of young children to cancer treatment and how parents can use music play activities to support their child during treatment. The music therapist will lead parent and child in a variety of music play activities. Parent and child will receive a music kit that includes items such as hand-held rhythm instruments, puppets, and a music CD. During the second and third visit the music therapist will lead parent and child child through the music play activities, answer questions, and make suggestions for using these activities in the hospital and at home.
15973551|NCT03085927|Behavioral|Audio Storybooks|Three 45-minute sessions with a board-certified music therapist delivered over three days. Sessions are delivered in a private setting during in-patient hospitalization. Each session children/parents will choose and listen to one of three illustrated children's books with audio recorded narration.
15973552|NCT03085914|Drug|Epacadostat|Epacadostat oral twice-daily continuous daily dosing at the protocol-defined dose.
15973553|NCT03085914|Drug|Pembrolizumab|Pembrolizumab
15973554|NCT03085914|Drug|Oxaliplatin|Oxaliplatin
15973555|NCT03085914|Drug|Leucovorin|Leucovorin
15973556|NCT03085914|Drug|5-Fluorouracil|5-Fluorouracil
15973557|NCT03085914|Drug|Gemcitabine|Gemcitabine
15973558|NCT03085914|Drug|nab-Paclitaxel|nab-Paclitaxel
15973559|NCT03085914|Drug|Carboplatin|Carboplatin
15973560|NCT03085914|Drug|Paclitaxel|Paclitaxel
15973561|NCT03085914|Drug|Pemetrexed|Pemetrexed
15973562|NCT03085914|Drug|Cyclophosphamide|Cyclophosphamide
15973563|NCT03085914|Drug|Carboplatin|Carboplatin
15973564|NCT03085914|Drug|Cisplatin|Cisplatin
15973565|NCT03085914|Drug|5-Fluorouracil|5-FU
15973566|NCT03085914|Drug|Investigator's choice of platinum agent|Investigator's choice of platinum agent: carboplatin or cisplatin
15973567|NCT03085901|Device|Precizon toric intraocular lens|Phacoemulsification and implantation of Precizon toric intraocular lens
15973568|NCT03085901|Device|Tecnis toric intraocular lens|Phacoemulsification and implantation of Tecnis toric intraocular lens
15973569|NCT03085849|Drug|Durvalumab|1500 mg IV on day 8 (flat dose) until progression
15973570|NCT03085849|Drug|Tremelimumab|75 mg IV on day 8 (flat dose) x 4 doses
15973571|NCT03085849|Drug|SGI-110|"SC daily for 5 days (days 1-5) until progression or toxicity
~Dose escalation scheme:
~Dose level -1 - SGI-110 20 mg/m2 SC daily; Dose level 0 - SGI-110 30 mg/m2 SC daily; Dose level 1 - SGI-110 45 mg/m2 SC daily; and SGI-110 given on days 1-5 of every 28 day cycle"
15973572|NCT03085836|Drug|TAK-438|TAK-438 tablets.
15973573|NCT03085823|Device|Sirolimus Coated Balloon|
15973575|NCT03085797|Drug|Mepolizumab|Mepolizumab injection 100 mg/millilitre (mL) is a clear to opalescent, colorless to pale yellow to pale brown sterile solution for SC injection in a single-use, safety syringe.
15973576|NCT03085797|Drug|Placebo|Placebo is a clear to opalescent, colorless sterile solution for SC injection in a single-use, safety syringe.
15973577|NCT03085797|Drug|Mometasone furoate|All participants will receive mometasone furoate usually 400 micrograms (mcg), 2 actuations (50 mcg/actuation) in each nostril twice daily. Intolerant participants will use 200g (2 actuations [50 g/actuation] in each nostril once daily).
15973578|NCT03085784|Drug|Aflibercept|The investigational product is intravitreal aflibercept injection (IAI), which will be supplied by Regeneron Pharmaceuticals, Inc. in sterile vials for intravitreal (IVT) injection. The study duration will be 52 weeks. Vials of drug must be used (defined as entered with needle) only once. All drug supplies are to be kept under recommended storage conditions. The injection volume will be 50μL (0.05 mL) and will be administered to the patients by IVT injection.
15973579|NCT03085771|Drug|desferal|It is a blinded randomized cross-over study that investigates the efficacy of DFO (50mg/kg) given i.v before intermittent hypoxia (IH) to improve the cardiorespiratory and angiogenetic response in patients with diabetes.
15973580|NCT03085771|Drug|Isotonic saline|It is a blinded randomized cross-over study that investigates the efficacy of isotonic saline given i.v before intermittent hypoxia (IH) to improve the cardiorespiratory and angiogenetic response in patients with diabetes.
15973581|NCT03085758|Biological|Adrecizumab|Single i.v. dose of 2 mg/kg (treatment arm A) or 4 mg/kg (treatment arm B)
15973582|NCT03085758|Biological|Placebo|Single i.v. dose of placebo (control group)
15973583|NCT03085745|Other|Transcranial Magnetic Stimulation (TMS)|TMS is a non invasive brain stimulation technique which allows to measure corticospinal excitability from peripheral muscles.
15973584|NCT03085732|Drug|Irrigation with Saline Solution|During hysterectomy after vaginal cuff closure 500-1000 mL saline irrigation will be done.
15973585|NCT03085719|Drug|Pembrolizumab|Keytruda is designed to restore the natural ability of the immune system to recognize and target cancer cells
15973586|NCT03085719|Radiation|Radiation|Radiation is used to shrink the cancer
15973587|NCT03085706|Biological|PBMC autotransplantation|Fourteen amyotrophic lateral sclerosis (ALS) patients are received peripheral blood mononuclear cell (PBMC) autotransplantation.
15973588|NCT03085680|Drug|Curcumin|Participants will be given curcumin (1000 mg/day), and will be instructed to consume two 500 mg capsules prior to breakfast every morning with a glass of water. Participants will be instructed to follow this dosing regimen throughout the entire three-month treatment period. Compliance with the dosing regimen will be monitored both through interview and by counting capsules left at monthly clinic visits.
15973589|NCT03085680|Drug|microcrystalline cellulose|Participants will be instructed to consume two capsules prior to breakfast every morning with a glass of water. Participants will be instructed to follow this dosing regimen throughout the entire three-month treatment period. Compliance with the dosing regimen will be monitored both through interview and by counting capsules left at monthly clinic visits.
15973590|NCT03085654|Drug|Oxytocin nasal spray|Intranasal administration of oxytocin 24 international units per dose.
15973591|NCT03085654|Drug|Placebo nasal spray|Intranasal administration of placebo 24 international units per dose.
15973624|NCT03085355|Procedure|Exercises and PNE|Exercise for stretching and strength for neck muscles and pain neuroscience education
15973592|NCT03085641|Device|Nasal high flow oxygen therapy|nHFT will be titrated during a first titration night and used at home during the night for 4 weeks consecutively
15973593|NCT03085628|Drug|Oxytocin|40IU
15973594|NCT03085628|Drug|Placebo|40IU
15973595|NCT03085615|Other|Jevity 1.5|Jevity 1.5 is an enteral nutrition product delivering 1.5 kcals/mL and 0.06 g protein/mL.
15973596|NCT03085602|Behavioral|Cognitive behavioral therapy|Therapy focused on explaining the physiological and psychological effects of nicotine. Training is focused on adherence to smoking instructions, physiological and psychological effects of nicotine, reviewing reasons for quitting, and coping with smoking urges. Smokers will be asked to begin smoking on a set schedule leading up to their quit day.
15973597|NCT03085602|Behavioral|Health education|Therapy that provides health education on the importance of healthy eating. Participants will be instructed to smoke as usual.
15973598|NCT03085563|Drug|Nitrous Oxide|Nitrous oxide will be delivered in one of two ways, using the titration method or rapid infusion method. Which ever method is used will be recorded. When using the titration method, starting at 20%, nitrous oxide will be added in 10% increments every 60 seconds until the ideal level of sedation has been met (not to exceed 70% nitrous oxide). Using the rapid infusion method, after the proper flow rate has been achieved with oxygen, the flowmeter will be increased to obtain 50% concentration of nitrous oxide. After 2-3 minutes if the patient does not have adequate sedation, nitrous oxide concentration will be increased to 70%.
15973599|NCT03085563|Drug|Midazolam|Intranasal midazolam with mucosal atomizer device administration will follow the Children's Hospital Colorado (CHCO) established policy 'Intranasal Administration (atomization) of Medications'. As per standard of care, each patient will receive a standardized dose of 0.4mg/kg (maximum dose of 10mg) of intranasal midazolam with the mucosal atomizer device for all procedures.
15973600|NCT03085550|Procedure|Fat grafting|Single treatment fat grafting infiltrated into diabetic ulcer wound
15973601|NCT03085550|Procedure|Fat grafting + platelet rich plasma|Single treatment fat grafting mixed with autologous platelet rich plasma infiltrated into diabetic ulcer wound. Autologous PRP is obtained using the ANGEL(TM) Concentrated Platelet Rich Plasma (cPRP) Separation Device which is FDA-regulated and CE certified
15973602|NCT03085524|Diagnostic Test|Platelet function testing|The investigators will test platelet reactivity at the beginning and midpoint of the first year after revascularization
15973603|NCT03085524|Diagnostic Test|Vascular ultrasonography|The investigators will test bypass graft and stent patency at 30 days, 6 months, and 1 year.
15973604|NCT03085511|Behavioral|Egg breakfast (EB)|Breakfast is considered as high quality protein diet, but has similar weight, energy, and macronutrients as the active comparator. The details are as follows: weight 291 g,energy 400 kcal, energy density 1.37 kcal/g, carbohydrate 42.9%, fat 35.6%, protein 19.8%, protein digestibility corrected amino acid score (PDCAAS) 100, leucine 1.77 g, glycemic load 24, fiber 1.0 g.
15973605|NCT03085511|Behavioral|Weight Loss Counseling|Weight loss counseling will be administered by a Registered Dietitian and will utilize information and materials derived from the Evidence Analysis Library (EAL) of the Academy of Nutrition and Dietetics (AND). Topics will include portion control, macronutrient distribution, snacking, eating out, cooking and grocery shopping, as well as behavioral strategies including self-monitoring, motivational interviewing, goal setting, and problem solving.
15973606|NCT03085511|Behavioral|Weight Loss Diet|Participants will have a 1200-1500kcals diet based on each individual's body weight during the study.
15973607|NCT03085511|Behavioral|Cereal Breakfast (CB)|Breakfast is considered as low quality protein diet, but has similar weight, energy, and macronutrients as that in experimental group. The details are as follows: weight 293 g, energy 398 kcal, energy density 1.36 kcal/g, carbohydrate 44.8%, fat 35.4%, protein 19.8%, protein digestibility corrected amino acid score (PDCAAS) 42, leucine 0.48 g, glycemic load 30.8, fiber 4.4 g.
15973608|NCT03085498|Other|No intervention|no intervention
15973609|NCT03085485|Drug|Ivacaftor 150 MG|Ivacaftor is a CFTR potentiator
15973610|NCT03085485|Drug|Placebo|placebo pills
15973611|NCT03085459|Behavioral|work Time|nurse got qualification certificate and the working time
15973612|NCT03085446|Behavioral|PDM nutritional intervention|personalized, diet-induced alterations in microbiota (PDM) for six months. (1) A 14-day running-in, no-treatment baseline assessment of all outcomes (T0); (2) A 6-month intervention period, with repeated assessments of all outcomes during the last two weeks of months 3 (T1) and 6 (T2). (3) A 12 month follow up (T3).
15973613|NCT03085446|Behavioral|General information on nutrition and health|General information on nutrition and health for six months: (1) A 14-day running-in, no-treatment baseline assessment of all outcomes (T0); (2) A 6-month intervention period, with repeated assessments of all outcomes during the last two weeks of months 3 (T1) and 6 (T2). (3) A 12 month follow up (T3),
15973614|NCT03085433|Device|Microfluidic Sperm Sorting|Microfluidic technology isolates healthy sperm by laminar flow, creating gradients through channels. The microfluidic chip we plan to study in our randomized clinical trial utilizes space-constrained microfluidic sorting to select highly motile and morphologically normal sperm in a flow and chemical-free design. Unlike the standard of density gradient centrifugation, no manipulation of sperm is required in this process. Raw semen is introduced into the inflow and only motile and morphologically normal sperm are able to swim through the chip to the outflow where it is collected for use.
15973615|NCT03085433|Procedure|in vitro fertilization|ivf/icsi
15973616|NCT03085420|Diagnostic Test|Echocardiogram|A baseline Echocardiogram test (ECHO) will be done one week from admission and monthly (+/- 1 week) or as ordered by a cardiologist.
15973617|NCT03085407|Procedure|early cholecystectomy|cholecystectomy was done within 48 after admission
15973618|NCT03085407|Procedure|delayed cholecystectomy|cholecystectomy was done after 30 days after randomization
15973619|NCT03085394|Drug|tranexamic acid|Preoperative intravenous administration of 2 grams tranexamic acid in 10 ml saline
15973620|NCT03085394|Drug|Placebo|Preoperative intravenous administration of 10 ml saline
15973621|NCT03085381|Biological|HPV vaccine|
15973622|NCT03085381|Biological|Placebo|
15973623|NCT03085368|Drug|lapatinib/herceptin|Lapatinib produced by glaxosmithkline. Oral small molecule epidermal growth factor tyrosine kinase inhibitor. Mainly used for combined with capecitabine in the treatment of ErbB-2 over expression, including received prior anthracycline, paclitaxel and trastuzumab (Herceptin) in the treatment of advanced or metastatic breast cancer. Our clinical trial want to see its benefit in early breast cancer
15973625|NCT03085355|Procedure|Osteopathic manipulative treatment|Osteopathic manipulative treatment associated exercise for stretching and strength for neck muscles and pain neuroscience education
15973626|NCT03085342|Diagnostic Test|Liver MRI|Multiparametric Liver MRI including following sequences: DCE, DWI, MRE, precontrast flow measurement, fat quantification.
15973627|NCT03085329|Device|Seattle-PAP|Seattle-PAP is a modified bubble CPAP device that has been given 510(k) clearance by the US FDA (K131502, October 11, 2013) and is thus recognized as substantially equivalent to other approved devices on the market. Results of a recently completed study in infants indicate that Bn-CPAP is associated with lower effort to breathe by spontaneously breathing premature infants.
15973628|NCT03085329|Device|Conventional bubble nasal CPAP|Infants enrolled in the study and randomized to this arm will be given respiratory support by bubble nasal CPAP using the Fisher & Paykel bubbler device, which is the standard of care at Nationwide Children's.
15973630|NCT03085303|Device|Full Body Blue Light Device|Full body blue light irradiation (phototherapy) of atopic dermatitis patients.
15973631|NCT03085290|Other|Autologous serum eye drops|Autologous serum eye drop doses will be 6 times daily in each eye
15973632|NCT03085290|Other|Allogeneic serum eye drops|Allogeneic serum eye drop doses will be 6 times daily in each eye
15973633|NCT03085277|Dietary Supplement|Bovine Colostrum|Bovine colostrum (BC) is the first milk from cows after birth and we suggest that BC may be used to supplement MM, instead of infant formula or DM. BC is a rich source of protein (up to 150 g/L) and bioactive components, including lactoferrin, lysozyme, lactoperoxidase, immunoglobulins, and various growth factors, such as, IGF-I and -II, EGFs, and TGF-β. BC has repeatedly been shown to have beneficial effects in a well-established piglet model of preterm infants, using various feeding regimens, including a gradual regimen that would mimic enteral feeding for preterm infants without access to MM during the first week.
15973634|NCT03085277|Dietary Supplement|Preterm Formula|Preterm formula is a type of infant formula designed for preterm infants. It is used when mother's own milk is not available or not in sufficient amount as the enteral feeding for preterm infants in hospitals that do not have donor human milk.
15973635|NCT03085264|Behavioral|Community Health Worker|Community Health Workers calls, texts and visits patient to support them in pre-established care plans as well as medication compliance/appointment attendance
15973636|NCT03085251|Device|Blood glucose monitoring systems for self-testing (BGMS)|"Measurement procedure
~Subjects will be asked to wash and dry their hands before the measurements.
~The measurement procedure for each reagent system lot of a BGMS will be as follows:
~Study personnel will collect a capillary blood sample from the subject's fingertip by skin puncture.
~Duplicate measurements on the sample will be consecutively performed with 2 test meters using reagent system units from the same vial / package.
~Capillary blood for measurements with all 3 test strip lots and for both comparison measurements will be taken from the same finger puncture.
~The sample will be applied to the reagent system units following specifications in the manufacturer's labelling."
15973637|NCT03085238|Device|M-Trap|Device(s) will be surgically implanted in the peritoneal cavity. Up to three (3) M-Trap devices will be surgically implanted via laparotomy in the right and left paracolic (pelvic) gutters and behind segment 6 of the liver within the peritoneal cavity of the patient at the time of surgical resection. Patients will receive standard platinum-based chemotherapy. If the cancer is diagnosed to have recurred, M-Trap devices with captured tumor cells will be removed via minimally invasive surgery (laparoscopy).
15973638|NCT03085225|Drug|Combination of trabectedin with durvalumab|"Dose Escalation : 3 doses of trabectedin given in combination with durvalumab (fixed dose) will be investigated.
~A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.).
~Expansion cohorts: Once the Maximum Tolerated Dose (MTD) has been defined, the expansion cohorts will be opened. All patients will be treated at the MTD of Trabectedin (as defined in the dose escalation part of the trial) given in association with Durvalumab with the same schedule as in the dose escalation part of the trial."
15973639|NCT03085212|Behavioral|Stress Free Now|Online stress management program developed by the Cleveland Clinic that uses mindfulness and cognitive-behavioral therapy to help individuals manage their stress.
15973640|NCT03085199|Procedure|Laparoscopic reinforcement suture|After cutting of duodenal stump of about 2 cm length using linear stapler, LARS commenced from upper to lower part on staple-line of duodenal stump. Continuous suture with invagination was performed using a barbed suture. In case of patient with short duodenal stump because of chronic ulcer or ectopic pancreas at duodenal bulb, 2 or 3 interrupted sutures without invagination of duodenal stump was conducted using barbed sutures.
15973641|NCT03085186|Drug|Crizotinib|
15973642|NCT03085173|Biological|EGFRt/19-28z/4-1BBL CAR T cells|Cohorts of 3-6 patients will be infused with escalating doses of EGFRt/19-28z/4-1BBL CAR T cells to establish the maximum tolerated dose (MTD). There are 4 planned dose levels: 1 x 10^5, 3 x 10^5, 1 x 10^6, and 3 x 10^6 CAR T cells/kg.
15973643|NCT03085160|Behavioral|Learning to Breathe|Six-session group program that involves meditation and interactive activities to learn mindfulness skills for coping with stress
15973644|NCT03085160|Behavioral|Health Education|Six-session group program that covers topics important for healthy living such as avoiding drug use, conflict resolution, bullying, sun safety and others
15973645|NCT03085147|Drug|Olaparib|For PARRi-FL, imaging patients will first gargle a solution of PARRi-FL for 1 min, then spit out this solution and gargle with a cleaning solution (the solvent used for PARRi-FL) for 1 min. Then fluorescence imaging of the oral cavity and pharynx will be performed with an endoscope. The intensity and extent of the fluorescence signal will be recorded by one of the investigators for the tumor and adjacent normal mucosa.
15973646|NCT03085134|Other|Test infant formula with HMOs|Extensively hydrolysed (whey protein) specialty infant formulas (FSMP) with HMOs intended for management of CMPA.
15973647|NCT03085134|Other|Control infant formula without HMOs|Extensively hydrolysed (whey protein) specialty infant formulas (FSMP) intended for management of CMPA.
15973648|NCT03085121|Procedure|Distal femoral resection in total knee arthroplasty|EM and IM alignment systems are used to make the distal femoral cut in a random order.
15973649|NCT03085108|Other|No Intervention|No Intervention
15973753|NCT03084276|Other|High-fat meal|High-fat meal
15973650|NCT03085095|Drug|Relugolix|Relugolix 120-mg tablet administered orally once daily following an oral loading dose of 360 mg (3 x 120-mg tablets) on Day 1
15973651|NCT03085095|Drug|Leuprolide Acetate|Leuprolide acetate depot suspension, 22.5 mg (or 11.25 mg in Japan, Taiwan, and China), every 3 months by subcutaneous injection
15973652|NCT03085082|Diagnostic Test|blood type test|a blood sample will be withdrawn from the subjects tested by anti A anti B and anti D antigens to detect the individuals blood group and RH. then statistical analysis to detect presence of a relationship between skeletal types of malocclusion and ABO blood groups
15973653|NCT03085069|Biological|SHR-1210|SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
15973654|NCT03085056|Drug|Trametinib|trametinib orally 2mg daily during each 4 week cycle
15973655|NCT03085056|Drug|Paclitaxel|paclitaxel 80mg/m^2 weekly for 3 out of 4 weeks
15973656|NCT03085043|Procedure|Bone Scan|Undergo bone scan
15973657|NCT03085043|Procedure|Computed Tomography|Undergo CT of the abdomen and pelvis
15973658|NCT03085043|Procedure|Magnetic Resonance Imaging|Undergo pelvic MRI
15973659|NCT03085043|Procedure|Magnetic Resonance Whole Body Diffusion-Weighted Imaging|Undergo magnetic resonance whole body diffusion-weighted imaging
15973660|NCT03085030|Drug|Antioxidant Formula|Antioxidant tablet will be taken by the patients
15973661|NCT03085030|Drug|Placebo|The placebo will be taken by the patients
15973662|NCT03085017|Device|BoneSeal|BoneSeal® is an absorbable synthetic bone hemostats that also contains of PLA, PEG and hydroxyapatite which supports bone re-growth. Product code MTJ. FDA number K142348.
15973663|NCT03085017|Device|Ostene|OSTENE is a synthetic, biodissolvable implant material that, provides immediate bone hemostasis, can be used on all bleeding bone surfaces, is completely biocompatible and water-soluble polymer, is a mechanical barrier that does not act biochemically.
15973664|NCT03085004|Drug|Ethanol|The cyst will be lavaged for 3 to 5 minutes using 98% ethanol as the lavage agent prior to infusing the cyst with the paclitaxel + gemcitabine admixture.
15973665|NCT03085004|Drug|Normal saline|The cyst will be lavaged for 3 to 5 minutes using normal saline as the lavage agent prior to infusing the cyst with the paclitaxel + gemcitabine admixture.
15973666|NCT03085004|Drug|Paclitaxel + Gemcitabine admixture|Following lavage, cysts will be infused with an admixture of 3mg/ml paclitaxel and 19mg/ml gemcitabine.
15973667|NCT03084978|Procedure|General Anesthesia|General anesthesia by standard endotracheal intubation.
15973668|NCT03084978|Procedure|Conscious Sedation|Conscious sedation
15973669|NCT03084952|Drug|18-Methoxycoronaridine|Drug under evaluation for leishmaniasis treatment
15973670|NCT03084952|Drug|Glucantime|Leishmaniasis standard drug in Brazil
15973671|NCT03084939|Biological|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) was administered intravenously on Day 1 of each 21-day cycle.
15973672|NCT03084939|Drug|Lapatinib|Lapatinib 1250 mg was administered orally once per day of each 21-day cycle.
15973673|NCT03084939|Drug|Capecitabine|Capecitabine 1000 milligrams per square meter (mg/m^2) was administered orally twice daily on Days 1-14 of each 21-day cycle.
15973674|NCT03084926|Drug|MP0274|Intravenous infusion of MP0274 as single agent at four planned dose levels, every three weeks until progressive disease, unacceptable toxicity or patient withdrawal for other reasons
15973675|NCT03084913|Other|Plant- based, olive oil diet|used as part of daily diet, followed for 8 weeks
15973676|NCT03084913|Other|Prostate Cancer Foundation diet|followed for 8 weeks
15973677|NCT03084900|Other|Arm 1|Patient-Centered Decision Support to Improve Diabetes Mgmt. We will use a computerized decision support system to aid clinicians to provide standard of care management while introducing patient-centered guidelines and outcomes measures.The intervention is the use of an electronic decision support tool. The decision support tool consists of a series of questions answered by the patients that will then allow the health care provider to address specific needs during the visit.
15973678|NCT03084887|Behavioral|manuals and follow-up|distribute manuals for patients before discharge and telephone follow-up per week until secondary hospital
15973679|NCT03084874|Behavioral|Physical activity and sedentary behavior coaching program|The intervention group will receive an individualized coaching program. During a motivational interview an experienced physiotherapist will asses participant's usual exercise habits, possible barriers and facilitators, self-efficacy and motivation to increase physical activity and reduce sedentary time. Based on these data (and baseline physical activity/sedentary information) an individualized, progressive program with specific goals setting and self-monitoring will be established (patients will be active participants and decision makers in this process).
15973680|NCT03084861|Drug|Cord Blood Eye Drops|Eye drops plasma from cord blood diluted v/v with Plasmalyte®, without antimicrobial preservatives
15973681|NCT03084861|Drug|Conventional treatment|"Artificial tears: Lubristil ®
~Therapeutic Contact lens: Air Optix Night&Day"
15973682|NCT03084848|Other|Training|25 training sessions of 15 minutes per day, 5 days a week for a month of crystallised intelligence
15973683|NCT03084848|Other|Training|25 training sessions of 15 minutes per day, 5 days a week for a month of inhibitory control
15973684|NCT03084835|Behavioral|Usual Care|Brief cessation counseling
15973685|NCT03084835|Behavioral|WEB+TXT|Access to Become an Ex website plus text messaging
15973686|NCT03084835|Behavioral|WEB+TXT+TTS|Access to Become an Ex website plus text messaging plus consult with a trained tobacco treatment specialist
15973687|NCT03084822|Behavioral|FAITH! App digital intervention|The digital app will include 10 education modules addressing the major CVD risk factors to be delivered on-demand through an innovative, interactive video series. The digital app will also support the multi-media education modules, interactive surveys/quizzes, self-monitoring (diet, physical activity), and social networking (discussion board) functionality.
15973688|NCT03084809|Drug|Cytokine-induced killer cells+ FOLFOX4|Day 1: Oxaliplatin 130 mg/m² IV infusion in 500 mL D5W. Day 2-6: leucovorin 200mg/m² IV infusion in D5W both given over 2 hours at the same time in separate bags Day 2-6: 5-FU 500 mg/m² IV bolus given continuously over 4-6 hours. The treatment is given for 4-6 cycles, every 3 weeks. Collected CIK cells were suspended with 100ml saline (containing 5ml 20% human serum albumin) and given continuously over 2 hours/ day for 3 days.
15973754|NCT03084276|Other|Low-fat meal|Low-fat meal with the same physical and organoleptic characteristics as the high-calorie meal.
15973689|NCT03084809|Drug|FOLFOX4|Day 1: Oxaliplatin 130 mg/m² IV infusion in 500 mL D5W. Day 2-6: leucovorin 200mg/m² IV infusion in D5W both given over 2 hours at the same time in separate bags Day 2-6: 5-FU 500 mg/m² IV bolus given continuously over 4-6 hours. The treatment is given for 4-6 cycles, every 3 weeks.
15973690|NCT03084796|Drug|CHF 5259|Dose Response: Test one of four different doses of CHF 5259
15973691|NCT03084796|Drug|Placebo|Placebo Control
15973692|NCT03084796|Drug|Tiotropium Bromide 18 µg Inhalation Capsule|Active Control
15973693|NCT03084783|Drug|Dexamethasone|Participants receive dexamethasone 10mg intravenously 6 hourly for 4 days.
15973694|NCT03084770|Diagnostic Test|Radiological imaging studies|Patients will be submitted to radiological imaging studies (CT scan and/or MRI and/ or 68Gallium PET/CT and/or Octreoscan and/or EUS+FNAand/or Octreoscan and/or EUS+FNA) at diagnosis, and then every 6 months for the first two years and yearly thereafter for five years in the absence of significant changes on imaging or symptoms appearance. Every 12 months (or 6 months for patients with Ki67> 2%) a high quality imaging (CT scan or MRI) is required.
15973695|NCT03084770|Other|Quality of Life Assessment|quality of life and the perceived burden of surveillance or follow-up after surgery for participants, will be investigated by administrating HADS questionnaire and EORTC QLQ-C30 (version 3) and EORTC QLQ-GI.NET21 Module.
15973696|NCT03084757|Diagnostic Test|research of druggable molecular alterations on tumor biopsy|The study will run in 2 steps. Before starting a new treatment, patients with advanced cancer will undergo a tumor biopsy of a metastatic site in order to perform molecular analyses seeking for druggable molecular alterations
15973697|NCT03084744|Behavioral|Schema therapy|Schema therapy for chronic depression, a face-to-face psychological intervention by clinical psychologists.
15973698|NCT03084744|Behavioral|Active monitoring|Active tele-monitoring by clinical psychologists.
15973699|NCT03084731|Dietary Supplement|Microbiota Directed Complementary Food (MDCF)|"For Study 1: Investigators will test 3 prototype MDCFs and the current RUSF standard of care for MAM to establish the effect size of each on MAZ repair in a 4 week twice daily intervention, with a 2 week post-intervention phase.
~Study 2: From study 1 Investigators will select most efficacious MDCF and compare with 2 additional MDCF prototypes to establish the effect size of each on MAZ repair in a 4 week twice daily intervention, with a 2 week post-intervention phase.
~Study 3: Investigators will select the lead MDCF from study 2 and examine the effects between the final MDCF versus current RUSF and also examine the impact dispensing of the lead MDCF once versus twice per day with a 4 week post-intervention period."
15973700|NCT03084718|Drug|CHF 781|Dose Response: Test one of three different doses of CHF 781
15973701|NCT03084718|Drug|Placebos|Placebo Control
15973702|NCT03084718|Drug|Beclomethasone Dipropionate|Active Control
15973703|NCT03084705|Device|Manumeter|A manumeter is a first-of-its-kind magnetic sensor to wirelessly detect hand and arm movement in a socially acceptable and easy to don package. The study participants will wear a small magnet as a ring, and a sensing/logging wristband detects changes in the magnetic field as the ring moves; the wristband can detect arm accelerations.
15973704|NCT03084692|Behavioral|Therapeutic Yoga and Resistance Exercise|Combined Program of Yoga and Resistance Exercise
15973705|NCT03084679|Other|Aerobic exercise in treadmill|30-40min of aerobic exercise in treadmill. The aerobic intensity will be established by heart rate levels that corresponded to anaerobic threshold up to 10% below the respiratory compensation point obtained in the cardiopulmonary exercise test. This intensity corresponded to 60-72% peak V̇o2. During the exercise sessions, when a training effect will be observed, as indicated by a decrease by 8 to 10% in heart rate, the treadmill velocity or inclination will be increased to return to the target heart rate levels.
15973706|NCT03084679|Other|Local strengthening exercises|15 min of local strengthening exercises will be performed in major muscle groups (legs, arms and trunk muscles): three series of each exercise, 12-15 repetitions.
15973707|NCT03084679|Other|Stretching exercises|5-min stretching exercises will be performed in major muscle groups (legs, arms and trunk muscles)
15973708|NCT03084666|Device|Zimmer ATS tourniquet system|The tourniquet is the same kind that is used in orthopedic surgeries to limit blood loss in arm or leg surgery. It can be inflated to a set pressure for a set amount of time.
15973709|NCT03084653|Other|Survey|Close-ended survey will be performed to the participants. The survey consisted of 18 questions (Appendix). The first six questions (#1-6) were related with respondent's demographical and educational data and experiences of surgical and laparoscopic practices. There were five questions to determine preferred technique for first entry (#7-11), three questions for complications (#12-14), and remaining four questions for safety maneuvers (#15-18).
15973713|NCT03084627|Behavioral|Tailored dietary advice|The nutrient adequacy of the diet of each patient will be evaluated, at baseline, by a diet quality index: the PANDiet. Then, tailored dietary advice aiming at improving the nutrient adequacy of the diet will be generated for each patient in the arm #2. Patients will choose 3 tailored dietary advices among 3 options during three appointments with a research project team member (the first in person and the second and the third by phone). Each appointment will be spaced of 2 weeks. In total, each patient in the arm #2 will choose nine tailored dietary advice. Tailored dietary advices are of two kinds: substitution of a consumed food item by a food item in the same food subgroup or modification of the consumed amount (increase or decrease) of a food item. Tailored dietary advices cannot generate an increase of more than 190 kcal or a decrease as compared to the observed energy intake.
15973714|NCT03084601|Drug|Calcium Hydroxide, Iodoform, paste|mixture of calcium hydroxide and iodoform
15973715|NCT03084601|Drug|3-mixtatin|3-mixtatin mixture of ciprofloxacin, metronidazole, cefixime, and simvastatin
15973716|NCT03084588|Drug|methadone|Patients will be given methadone at induction of anesthesia
15973717|NCT03084588|Procedure|Interscalene block|Patients will be given an interscalene block prior to induction of anesthesia
15973755|NCT03084263|Procedure|Arthroscopic Assisted Open Reduction Internal Fixation|Surgical fixation of ankle fractures with use of arthroscopy.
15973756|NCT03084263|Procedure|Open Reduction Internal Fixation|Surgical fixation of ankle fractures.
15973718|NCT03084575|Procedure|Thermal radio Frequency, selective (unilateral S3, bilateral S4 and S5) saddle rhizotomy|Thermal RF lesioning is done using Bailys RF generator. TRF parameters are 80 C, 120 seconds the TRF lesion is repeated after 180 rotation of the needle tip again after sensory and motor pre-stimulation.
15973719|NCT03084575|Drug|hyperbaric chemical saddle Rhizotomy (6 % pherol in glycerin)|L5-S1 intrathecal injection of 0.5-1 ml of 6 % pherol in glycerin. The patient is seated in the sitting position with 30-45o leaning backwards to make the posterior sensory roots lowermost.
15973720|NCT03084575|Device|Thermal RF lesioning is done using Bailys RF generator|
15973721|NCT03084562|Other|collect examination time, functional and clinical tolerability|Examination time : time from patient setup and launch of the pre-test to the end of the patient monitoring Functional tolerability : functional assessed by the patient Clinical tolerability : clinical score by the cardiologist
15973722|NCT03084549|Drug|Administration of Ropivacaïne|Administration of Ropivacaïne in the margins of the episiotomy
15973723|NCT03084549|Drug|Administration of placebo|Administration of placebo in the margins of the episiotomy
15973724|NCT03084536|Drug|Bupivacaine|-Given after general anesthesia
15973725|NCT03084536|Drug|Gabapentin|"As per routine care
~Will not be prescribed for any patient with preexisting kidney disease or ≥ 65 years."
15973726|NCT03084536|Drug|Celecoxib|"As per routine care
~Will not be prescribed for any patient with preexisting kidney disease or ≥ 65 years.
~Naproxen will be substituted for celecoxib in patients with sulfa allergies."
15973727|NCT03084536|Drug|Acetaminophen|-As per routine care
15973728|NCT03084536|Drug|Midazolam|-As per routine care
15973729|NCT03084536|Drug|Fentanyl|-As per routine care
15973731|NCT03084510|Device|Lotus Edge™ Valve System|"• The Lotus Edge™ Valve System consisting of two main components:
~a bioprosthetic bovine pericardial aortic valve, and
~a delivery system Device sizes include 23 mm, 25 mm and 27 mm diameter."
15973732|NCT03084497|Procedure|Infant Massage|"The first day, investigators will make the initial assessment of the baby through Psychomotor Development Scale of Early Childhood Brunet- Lézine. Participants will keep the sessions early attention and will participate in the course of Infant Massage, which develop for 5 weeks.
~Infant Massage course will take place with families and is based on the methodology and program of the International Association of Infant Massage ( IAIM ), created by Vimala McClure. The course will consist of 5 sessions (one per week) approximately 90 minutes. Parents will practice everyday the movements learned during the time of the study.
~When the course of Infant Massage finished, Investigators will conduct the final evaluation of the baby, the same way as in the initial evaluation."
15973733|NCT03084484|Dietary Supplement|Kiwifruit addition to the diet|Subjects were instructed to eat two kiwifruit per day during the whole study period. No recommendation on the type of kiwifruit, brand or origin was delivered. Kiwifruit was suggested to be taken as a whole and not mixed with sugar or other ingredients. No changes to their routinely dietary habits were suggested.
15973734|NCT03084484|Procedure|Non Surgical periodontal treatment|Non-surgical treatment of periodontal pockets with hand and ultrasonic instrumentation
15973737|NCT03084458|Behavioral|Fitbit|The Fitbit device will allow experimental group participant access to their daily step count.
15973738|NCT03084432|Diagnostic Test|Dual Energy X-ray Absorptiometry|Dual Energy X-ray Absorptiometry done for both studied groups
15973739|NCT03084419|Drug|Abatacept|"The IV dose varies according to weight:
~<60kg=500mg
~≥60 but≤100kg=750mg >100kg=1g
~This equates to approximately 10mg/kg."
15973740|NCT03084406|Other|Centervention-ATOD (CV-ATOD)|A customizable suite of online tools specifically designed to support quality implementation and sustainability of any ATOD-EBP within real-world service settings.
15973741|NCT03084380|Biological|Retroviral vector-transduced autologous T cells to express anti-GPC3 CARs|transcatheter arterial chemoembolization + CAR-T infusion
15973742|NCT03084380|Drug|Fludarabine|Fludarabine will be administered at dose of 25mg/m2/d
15973743|NCT03084380|Drug|Cyclophosphamide|Cyclophosphamide will be administered at dose of 40mg/kg for 1 day and then fludarabine will be given for the next 5 days and then the T cells will be administered
15973744|NCT03084367|Diagnostic Test|iFR pullback|iFR pullback assessment post angiographically successful PCI
15973745|NCT03084354|Other|Semi-structured interviews|Semi-structure interviews to gain a deep understanding of women's experiences of maternity bladder care. Interviews will last between thirty minutes to a couple of hours and they will be digitally recorded and transcribed verbatim.
15973746|NCT03084341|Procedure|Neuromuscular Electrical Elongation|Electrotherapy equipment will be used, choosing an interferential current through bipolar application,with a frequency of 4 kHz and a frequency modulation amplitude of 100 Hz.
15973747|NCT03084341|Procedure|Proprioceptive Neuromuscular Facilitation|Hold-relax technique that involves lengthening the muscle to the point of limitation, at which point the individual performs an isometric contraction for up to 10 s, followed by a passive movement of the limb into the new end-range.
15973748|NCT03084328|Dietary Supplement|Vitamind D|Patients will be given an over the counter vitamin D supplement of 2000 units of D3 daily for 6 months
15973749|NCT03084315|Device|E-Cig Zero Nicotine|E-Cig Zero Nicotine
15973750|NCT03084315|Device|E-Cig 24mg Nicotine|E-Cig 24mg Nicotine
15973751|NCT03084289|Biological|ChAd63-METRAP|The candidate vaccine applicable to the clinical trial is the Chimpanzee adenovirus 63 expressing Multiple epitopes and thrombospondin related adhesion protein.
15973752|NCT03084289|Biological|MVA ME-TRAP|The candidate vaccine applicable to the clinical trial is the Modified Vaccinia virus Ankara expressing Multiple epitopes and thrombospondin related adhesion protein.
15973757|NCT03084250|Drug|Peginterferon Alfa-2A|180μg/week, 48 weeks; 135μg/week,48weeks
15973758|NCT03084250|Drug|Adefovir, entecavir,tenofovir, either of them|Adefovir, entecavir,tenofovir, either of them is ok
15973759|NCT03084237|Biological|HLX02|8 mg/kg administered intravenously over 90 minutes as a loading dose on Day 1, Cycle 1 then 6 mg/kg every 3 weeks for subsequent cycles.
15973760|NCT03084237|Biological|Herceptin®|8 mg/kg administered intravenously over 90 minutes as a loading dose on Day 1, Cycle 1 then 6 mg/kg every 3 weeks for subsequent cycles
15973761|NCT03084237|Drug|docetaxel|75 mg/m2 will be administered on Day 2, Cycle 1.then be given every 3 weeks on Day 1 of each subsequent cycle
15973762|NCT03084224|Genetic|neurological and neurodegenerative diseases|NGS on a large scale of Patients with complexes phenotypes
15973763|NCT03084211|Other|Light exercise discharge instructions|Participants in the intervention group will receive discharge instructions prescribing light exercise following mild traumatic brain injury.
15973764|NCT03084198|Procedure|hiHep Bioartificial Liver Support System|Continuous treatment with the hiHep bioartificial liver support system for a minimum of 3 days to a maximum of 14 days. The subject's ultrafiltrated blood is circulated through 4 cartridges. The parameter is set to Circuit 1：120-200ml/min；Circuit 2：30-50ml/min；Circuit 3：200 ml/min.
15973765|NCT03084198|Procedure|Standard care for ALF|A standard of care for subjects with acute liver failure.
15973766|NCT03084159|Behavioral|Education worksheet|Patients who screen positive for CKD and give written informed consent to be a part of the study will have their chart flagged for the medical assistant and provider to give the education worksheet intervention. The education worksheet has been developed to be used as an electronic tool within the Electronic Medical Record. The provider will review it with the patient during the visit. A paper copy will print out for the patient at the end of the visit.
15973767|NCT03084146|Other|12-week elimination diet|individualized 12-week elimination diet based on the 4 most reactive foods +/- a gluten-free diet if there is detection of positive anti- tissue transglutaminase (tTG) IgG and IgA and anti-deamidated gliadin peptide (DGP) IgG and IgA
15973768|NCT03084133|Behavioral|Therapeutic Education Strategy|"In the experimental arm of the study (intervention group), a screening information and education system will be implemented. The particularities of the index cases likely to require an adaptation of the device will be collected, analyzed and taken into account (level of health literacy, socio-economic status, level of education, professional activity ...). The analysis and intervention frameworks derived from theories on health behaviors will be mobilized (theory of reasoned action, theory of planned behaviors) and applied in order to reinforce the intention of the target audience. The analysis and intervention frameworks resulting from the educational sciences will be integrated with a competence approach (Aizen, 1991, Denovel, Dufour, Prochaska, 1983, Le Boterf, 2002)."
15973769|NCT03084120|Other|Collection of bloods samples for the mother|-During pregnancy, childbirth and after delivery
15973770|NCT03084120|Other|Retrieval of umbilical cord blood.|-During childbirth
15973771|NCT03084120|Other|Retrieval of placenta.|-During childbirth
15973772|NCT03084120|Other|Collection of newborn's and mother's lock of hair.|-During childbirth
15973773|NCT03084120|Other|Dietetic Patient Outcomes Questionnaires for the mother.|-During pregnancy and after delivery
15973774|NCT03084120|Other|Parental questionnaires : ASQ (Ages & Stages questionnaires) and CFQ (Child Feeding Questionnaire).|-At 2 years of age
15973775|NCT03084107|Other|Questionnaire|The elderly participated in the application of smart devices and requested to complete technology acceptance model (TAM) questionnaires for these devices.
15973776|NCT03084094|Device|Transcranial Direct Current Stimulation|Non invasive brain modulation at a 2mA current during 20minutes
15973777|NCT03084081|Device|CO2 standard therapy|Standard therapy using carbon dioxide for freezing of tissue
15973778|NCT03084081|Device|CryoPen|Provides a means of freezing tissue without the use of gases or liquids
15973779|NCT03084081|Device|Thermocoagulator|Thermoablation
15973780|NCT03084068|Other|Human dehydrated umbilical cord allograft|human dehydrated umbilical cord allograft
15973781|NCT03084068|Other|Placebo|Open rotator cuff surgery with standard suture repair
15973782|NCT03084055|Behavioral|eMotion|eMotion is comprised of a series of weekly audio visual modules designed to increase exposure to positive activities and physical activity
15973783|NCT03084042|Device|fMRI|
15973784|NCT03084029|Drug|Oxytocin|40 international units
15973785|NCT03084029|Drug|Placebo|40 international units
15973786|NCT03084003|Dietary Supplement|Almonds|
15973787|NCT03084003|Dietary Supplement|Graham crackers|
15973788|NCT03083990|Biological|IBI305(Bevacizumab Biosimilar)|3mg/kg, infusion in 90minutes
15973789|NCT03083990|Drug|Avastin(Bevacizumab)|3mg/kg, infusion in 90minutes
15973790|NCT03083977|Other|Safe and Sound Protocol|The intervention features music processed based on the resonating frequencies of the middle ear
15973791|NCT03083964|Behavioral|Usual Care|Usual care is not considered an intervention. This arm of the study involves a lifestyle coaching intervention delivered in primary care sites to the subjects.
15973792|NCT03083964|Behavioral|Priming|The intervention is a just in time eating or physical activity reminder. Each individual participant reports physical activity goals as well as times that they most often eat. This information is used to select for that individual the best time to send an eating or physical activity reminder. The reminders come to the participant's smartphone or a study provided smartphone. Participants will receive reminder 2 to 4 times per day depending on their goals and behavior pattern.
15973793|NCT03083951|Procedure|Complete mesocolon excision|Laparoscopic sigmoidectomy with lymphadenectomy of the lymphatic tissue that accompanies the inferior mesenteric vein and a high tie ligation of the inferior mesenteric artery (complete mesocolon excision)
15973794|NCT03083951|Procedure|Conventional locoregional lymphadenectomy|Laparoscopic sigmoidectomy with lymphadenectomy of the lymphatic tissue that accompanies the inferior mesenteric artery and a high tie ligation of the inferior mesenteric artery with or without section of inferior mesenteric vein.
15973795|NCT03083938|Procedure|Omental Roll-up|Using omentum roll-up pancreato-jejunal anastomosis
15973796|NCT03083925|Device|TIPS|Transjugular Intrahepatic Portosystemic Shunt
15973797|NCT03083912|Dietary Supplement|Fortimel Complete|The residents included receive 2 bottle por day.
15973798|NCT03083899|Other|Out-patient clinic on demand (patient-initiated)|Free use of any resources in the out-patient clinic
15973799|NCT03083899|Other|Scheduled out-patient clinic|Scheduled use of the out-patient clinic
15973800|NCT03083886|Other|Identify, Coordinated, Enhanced (ICE) Decision Making + PCP led care|Subjects seeking care at a clinic assigned to this arm will receive the ICE care model through referral by their primary care provider. The ICE care model was developed by the Clinical Excellence Research Center at Stanford University based on a review of the peer-reviewed literature for adult subjects with incident neck or back pain less than six weeks in duration who are not using high-dose opioid medications or receiving spine-related long-term disability payments.
15973801|NCT03083886|Other|Individualized Postural Therapy (IPT) + PCP led care|IPT involves the evaluation of a subject's posture to identify postural and alignment deviations and, based on this, a personalized corrective exercise program is prescribed. This method does involve the use of prescription medications, surgery, or manipulation. A treatment course typically lasts eight sessions over eight weeks. In order to allow for the consistent delivery of this arm of the study at multiple study-sites across the country, IPT will be delivered by The Egoscue Method. Egoscue was founded in 1971 and has 25 clinics worldwide.
15973802|NCT03083886|Other|Usual PCP led care|Primary care provider will direct patients' care pathway.
15973803|NCT03083873|Biological|LN-145|A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After NMA lymphodepletion, patients are infused with their autologous TIL (LN-145) followed by IL-2 administration.
15973804|NCT03083873|Biological|LN-145-S1|A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After NMA lymphodepletion, patients are infused with autologous TIL (LN-145-S1) followed by IL-2 administration.
15973805|NCT03083860|Device|BEI|BrainMARC Ltd. has demonstrated in recent years the ability to extract effective attention markers from averaged ERP waves sampled with a single EEG channel (two electrodes). In addition, BrainMARC has developed a template matching method to extract the attention-related markers at the single-trial level. An index (termed Brain Engagement Index - BEI) can then be generated from a 1-minute, single-channel sample.
15973806|NCT03083847|Drug|Chloroquine Phosphate|Chloroquine has been widely used for treatment and prophylaxis of malaria since 1946 (Most, London et al. 1984). It was the treatment of choice for uncomplicated malaria for decades because it was safe, well tolerated, affordable and highly effective for the treatment of malaria. However, increasing spread of chloroquine- resistant Pf over the last two decades has severely limited its use (Wellems 2002). Chloroquine phosphate is U.S Food and Drug Administration (FDA) approved for suppressive treatment (prophylaxis) and for acute attacks of malaria due to P. vivax, P. malariae, P. ovale, and susceptible strains of Pf.
15973807|NCT03083847|Drug|Pyrimethamine|Pyrimethamine is a folic acid antagonist that has been commonly used as antimalarial drug for both treatment and prevention of malaria, usually in combination with sulfadoxine in adults, pregnant women, and children worldwide (Organization April 2013 (rev. January2014)
15973808|NCT03083847|Biological|Sanaria PfSPZ Challenge|Sanaria Inc has manufactured two strains of Sanaria PfSPZ Challenge: NF54 and 7G8. The Sanaria PfSPZ Challenge contains fully infectious PfSPZ purified from the salivary glands of Anopheles stephensi mosquitoes raised under aseptic conditions. The infectious PfSPZ are formulated in cryoprotectant to maintain potency for an extended period. Sanaria PfSPZ Challenge (NF54) is known to be susceptible to chloroquine, pyrimethamine, atovaquone, artesunate, but not mefloquine. Sanaria PfSPZ Challenge (7G8) is known to be susceptible to mefloquine, atovaquone, artemether and artesunate but not to chloroquine or pyrimethamine.
15973809|NCT03083834|Diagnostic Test|Cosyntropin stimulation test|At 0800h to 0900h, a 25 mm plastic intravenous line will be inserted in an antecubital vein. Then, 1 μg/ml ACTH aliquot stock solution will be pushed through, followed by 5 ml physiologic saline (0.9%). Serum cortisol and salivary free cortisol will measured just before ACTH administration and 30 minutes later.
15973810|NCT03083821|Drug|Baraclude|Specified dose on specified day
15973811|NCT03083808|Drug|Pembrolizumab|"Pembrolizumab 200mg IV every 21 days
~+
~Physician's choice chemotherapy with one of the following every 21 days:
~Docetaxel 75mg/m2 IV
~Pemetrexed 500mg/m2 IV (non-squamous only)
~Gemcitabine 1000mg/m2 IV on days 1 and 8"
15973812|NCT03083795|Behavioral|Social relationships intervention|Participants randomized to the social interaction cohort will meet on a monthly basis for a two hour group session designed to build social connections. In addition, participants will be paired with another study participant in this group, and will be asked to meet on a monthly basis for a minimum of 45 minutes. All participants in the social support cohort will continue to receive best standard diabetes management.
15973813|NCT03083782|Drug|Apixaban alone|A single dose of 10 mg apixaban administered orally at 0H on Day 1.
15973814|NCT03083782|Drug|Cyclosporine|Once daily dose of 100 mg cyclosporine administered orally on Days 1 to 3.
15973815|NCT03083782|Drug|Tacrolimus|Once daily dose of 5 mg tacrolimus administered orally on Days 1 to 3.
15973816|NCT03083782|Drug|Apixaban|A single dose of 10 mg apixaban administered orally on Day 3 immediately following cyclosporine
15973817|NCT03083782|Drug|Apixaban|A single dose of 10 mg apixaban administered orally on Day 3 immediately following tacrolimus
15973818|NCT03083743|Biological|Recombinant human Apo-2 ligand for Injection|150μg/kg/d IV (in the vein), on day 1 to 7 of each 21 day cycle
15973819|NCT03083743|Biological|Placebo|150μg/kg/d IV (in the vein), on day 1 to 7 of each 21 day cycle
15973820|NCT03083730|Other|Narrow band UVB treatment (NB-UVB)|NB-UVB light treatment NB-UVB light treatment for 3x/week for 12 weeks (36 visits)
15973821|NCT03083717|Diagnostic Test|Collection of breath samples, followed by analysis of exhaled breath using nanomaterial-based sensors (NaNose)|2-3 liters of breath sample will be collected in chemically inert Mylar bags. The breath samples will then be immediately transferred from the Mylar bags to Tenax sorbent tubes using a dedicated pump. Tubes will be sealed and kept in 4˚C until NA-NOSE analysis.
15973822|NCT03083704|Biological|Andexanet alfa (Gen 1 Process 2)|factor Xa inhibitor antidote
15973823|NCT03083704|Drug|Apixaban 5 MG|factor Xa inhibitor
15973824|NCT03083704|Drug|Rivaroxaban 20 MG|factor Xa inhibitor
15973825|NCT03083704|Drug|Enoxaparin sodium|low molecular weight heparin
15973826|NCT03083704|Drug|Edoxaban 60 MG|factor Xa inhibitor
15973827|NCT03083704|Biological|Andexanet alfa (Gen 2)|factor Xa inhibitor antidote
15973828|NCT03083704|Biological|Andexanet alfa (Gen 1 Process 3)|factor Xa inhibitor antidote
15973829|NCT03083704|Drug|Apixaban 10 MG|factor Xa inhibitor
15973830|NCT03083704|Drug|Rivaroxaban 10 MG|factor Xa inhibitor
15973831|NCT03083691|Drug|Nivolumab, Ipilimumab|Cohort 1: addition of ipilimumab in case of progression on nivolumab monotherapy.
15973832|NCT03083691|Drug|Nivolumab, Ipilimumab|Cohort 2: upfront combination therapy of nivolumab and ipilimumab for four cycles, followed by nivolumab monotherapy.
15973833|NCT03083678|Drug|Afatinib|Afatinib will be given daily in a dose of 40 mg orally in a 4 week cycle until disease progression or patient withdrawal.
15973836|NCT03083652|Device|Neuromuscular electrical stimulation|Neuromuscular electrical stimulation (30 minutes per day, 5 days/week) of the quadriceps femoris and gluteus maximus
15973837|NCT03083652|Other|Sham|Conventional physiotherapy with NMES device NOT activated
15973838|NCT03083639|Drug|Esomeprazole Capsule|Esomeprazole Capsule
15973839|NCT03083639|Drug|Esomeprazole Tablet|Esomeprazole Tablet
15973840|NCT03083626|Other|Cold pressor test|"The cold pressor test is a procedure used for examining pain threshold and tolerance by subjects placing their forearm in an ice bath. Each participant will take the CPT at 1 °C, 5°C, and 9°C. The first CPT will always be at 1 °C, to ensure participants tolerate the ice bath at the standard temperature. The order of the subsequent CPT at 5°C and 9°C, will be randomized to control for differential carry over effects. Participants will be instructed to say Pain when pain is initially detected (threshold). Then they will be asked to keep the immersed limb in the container until the pain can no longer be tolerated and say Stop and remove the arm from the water when tolerance is reached."
15973841|NCT03083613|Drug|Raltitrexed|Raltitrexed:3mg/m2,iv,d1, Every 3 weeks
15973842|NCT03083613|Drug|Paclitaxel|Paclitaxel:80mg/m2,iv,d1,d8, Every 3 weeks
15973843|NCT03083600|Dietary Supplement|Plant-based Protein Hydrolysate 1|Plant-based Protein Hydrolysate 2 for 12-weeks
15973844|NCT03083600|Dietary Supplement|Plant-based Protein Hydrolysate 2|Plant-based Protein Hydrolysate 2 for 12-weeks
15973845|NCT03083600|Dietary Supplement|Placebo|Cellulose Placebo for 12-weeks
15973846|NCT03083587|Behavioral|Normal lifestyle|Normal lifestyle
15973847|NCT03083587|Behavioral|Exercise|Mild exercise 3 min every half hour
15973848|NCT03083587|Procedure|muscle and fat biopsy|Biopsy under local anesthesia
15973849|NCT03083587|Device|Continuous glucose monitoring|Glucose concentrations during the study period
15973850|NCT03083587|Device|Activity monitoring (ActivePal)|Objective measurements of standing and sitting time
15973851|NCT03083574|Device|Photopheresis Theraflex ECP™|The Macopharma (Theraflex ECP™) approach is based on a multistep procedure involving (1) standard mononuclear cell apheresis, (2) injection of the 8-Mop in the apheresis bag, (3) UVA exposure of the bag in the Macogenic illumination device, and (4) reinfusion of the cells into the patients.
15973852|NCT03083561|Drug|LY3337641|Administered orally.
15973853|NCT03083561|Drug|Placebo|Administered orally.
15973854|NCT03083548|Diagnostic Test|Imaging|Conventional radiographs (hands/feet), CT of dominant hand, MRI of dominant hand, ultrasound (hands/shoulder/feet/hips/knees), fluorescence optical imaging of hands
15973855|NCT03083548|Diagnostic Test|Physical examinations|Joint assessment of hands and feet, pain sensitization test and functional tests
15973856|NCT03083548|Diagnostic Test|Questionnnaires|Self-reported demographic factors, clinical variables and OA history and symptoms
15973857|NCT03083535|Procedure|Tooth Brushing|Tooth Brushing with Dentifrice Tooth Brushing with Dentifrice (Standard Tooth Brushing technique will be demonstrated by using same type of tooth brush and toothpaste).
15973858|NCT03083535|Procedure|aloe vera Massaging|Tooth Brushing with Dentifrice (with same type of tooth brush and toothpaste) and massaging with aloe vera gel
15973859|NCT03083535|Procedure|SRP with aloe vera massaging|on one side of the arch only Scaling and Root Planing(SRP) to be done, while on the other side, after the Scaling and Root Planing massaging with aloe vera ge; shall be carried out by the patients/subjects
15973860|NCT03083522|Drug|Ojeok-San|Usage: 3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
15973861|NCT03083522|Drug|Placebo|Usage: 3g three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
15973862|NCT03083509|Other|Resistance exercise weight training session|A resistance exercise session was performed. Following a warm-up that consisted of five-minutes cycling at a self-selected intensity, as well as three progressive lifts at 50, 75, and 90% 6 rep max (RM), participants performed four sets of six repetitions at 100% of 6RM (as determined by the maximal weight lifted during the maximal strength assessment) of the following lifts; back squat, front squat, good mornings, and Bulgarian split-squat. Two minutes rest was afforded between sets and exercises.
15973863|NCT03083509|Other|High-Intensity stochastic cycling session|A high-intensity stochastic cycling session was performed. The cycling protocol was performed using a magnetically-braked cycle ergometer (Velotron, RacerMate). Following a 10 minute standardised warm-up including 3 × 3s sprints, participants completed a simulated road-race, consisting of sprints of varied length, differing work to rest ratios and short time-trials.
15973864|NCT03083509|Other|Simulated Team sport protocol|A simulated team sport protocol was performed. Participants performed a standardised warm-up consisting of performing three laps of the circuit jogging, and three laps at 50, 75, and 90% of perceived maximal speed. Participants were then afforded five minutes to perform self-selected stretching prior to commencing the session. Participants performed two sets of 45 minutes of the simulated team sport protocol, separated by 15 minutes rest. Each 45 minute period consisted of a one minute circuit repeated 45 times that replicates typical movement patterns observed during team sports and includes walking, jogging, jumping, sprinting, agility, and decelerations. Each circuit was initiated on the minute, therefore enabling participants to rest following the completion of each circuit. Pilot testing showed participants completes each circuit in approximately 48-55 seconds (sec) therefore enabling 5-12sec rest after each circuit.
15973897|NCT03083249|Other|Gardasil|None-data gathering only
15973898|NCT03083236|Other|Standard PBI|Standard Parent Based Intervention (PBI)
15973865|NCT03083496|Drug|Potassium Oxalate 5%|Prophylaxis, apply uniformly on the teeth, friccion for 10 seconds, wait 10 minutes, remove the gel from the teeth with cotton and abundant water.
15973866|NCT03083496|Drug|Potassium Oxalate 10%|Prophylaxis, apply uniformly on the teeth, friccion for 10 seconds, wait 10 minutes, remove the gel from the teeth with cotton and abundant water.
15973867|NCT03083483|Device|transcranial direct current stimulation (tDCS)|tDCS will apply a low, direct current for the duration of the study session while the subject is training the specific laparoscopic tasks.
15973868|NCT03083470|Drug|SOR007 (Uncoated Nanoparticulate Paclitaxel) Ointment|SOR007 will be applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolve. The maximum total amount of SOR007 that will be applied daily will be 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, will be treated.
15973869|NCT03083470|Other|SOR007 Ointment Vehicle|SOR007 ointment vehicle will be applied topically to a target AK lesion test field twice daily for up to 28 days, or until all lesions resolve. The maximum total amount of Ointment vehicle that will be applied daily will be 1 finger-tip unit (FTU), approximately 0.5g. No more than 25cm2, approximately 0.15% of the total body surface area, will be treated.
15973870|NCT03083457|Drug|Fluid resuscitation or amine administration|Fluid administration or amine administration if deemed necessary by the attending physician. Haemodynamics will be monitored through noninvasive cardiac output assessment by arterial pulse contour analysis
15973871|NCT03083457|Drug|General anesthetic|Total intravenous anesthesia with a standard protocol
15973872|NCT03083457|Drug|Fluid administration|3-5 ml/kg of balanced crystalloids will be administered throughout the whole surgical procedure
15973873|NCT03083457|Procedure|Low-tidal volume ventilation|Volume-control ventilation with tidal volume=7 ml/kg of predicted body weight for the entire surgical procedure. Respiratory rate will be set to maintain EtCO2 within a physiological range and kept unchanged for the entire duration of the study
15973874|NCT03083457|Procedure|Scheduled recruiting maneuvers|Pressure-control ventilation inspiratory pressure=10 cmH2O. Steplike 5-cmH2O-PEEP increase every 30 seconds to achieve a peep of 35 cmH2O, followed by 5-cmH2O-PEEP reduction every 30 seconds to set PEEP
15973875|NCT03083444|Diagnostic Test|Ultrasound|Measurement of thickness of radial artery wall thickness by ultrasound
15973876|NCT03083431|Drug|Propranolol|Oral propranolol (1.6 mg propranolol-hydrochloride/kg.d in 4 divided dosages)
15973877|NCT03083431|Drug|Placebo|Oral solution containing the same excipients as propranolol solution
15973878|NCT03083418|Device|control group|No EDP treatment
15973879|NCT03083418|Device|EDP|Turn on the device, and clean the skin where the patch will be located according to the screen tip. Paste the two groups of small electrodes to the inferior 1/3 of the outer edge of bilateral sternocleidomastoid, and the large electrodes are pasted to the corresponding 2nd intercostal skin surface of pectoralis major at midclavicular line.Adjusting the stimulus intensity according to the daily maximum tolerance (patients with no pain and tension).30 minutes continuous stimulation each time, twice a day, a total of one weeks of treatment .
15973880|NCT03083405|Drug|Opipramol|The study group will get a drug to decrease bruxism activity. Group will be evaluated using polysomnography included rhythmic masticatory muscle activity registration before and after intervention.
15973881|NCT03083392|Procedure|treatment of chronic maxillary sinusitis using DIVA system|chronic maxillary sinusitis treatment utilizing DIVA system for antral lavage
15973882|NCT03083392|Device|"dynamic implant valve approach - DIVA system"|The DIVA system will be used to apply saline lavage to the maxillary sinus
15973883|NCT03083379|Device|Volumetric Incentive Spirometry|"A study investigator will provide instruction on Incentive Spirometry procedure performance before supervised therapy and monitoring begins.
~Five minutes of eupneic ventilation EIT monitoring will occur before I.S. therapy commences.
~Study participants will be asked to take 10 deep breaths through the incentive spirometer's mouthpiece, followed by a 60 second pause.
~The 10-breath cycle will be repeated three times with respiratory therapist coaching.
~Five minutes of eupneic ventilation EIT monitoring will occur following the last I.S. lung expansion therapy breath cycle.
~Incentive Spirometry therapy and monitoring session will last about 15 minutes"
15973884|NCT03083379|Device|EzPAP® POSITIVE AIRWAY PRESSURE|"A study investigator will provide instruction on EzPAP® procedure performance before supervised therapy and monitoring begins. A second study investigator will perform EIT device set-up and monitoring only.
~Five minutes of eupneic ventilation EIT monitoring will occur before EzPAP® therapy commences.
~Study participants will be asked to breathe normally through the EzPAP® device's mouthpiece for 10 breaths, followed by a 60 second pause.
~The 10-breath cycle will be repeated three times with respiratory therapist coaching.
~Five minutes of eupneic ventilation EIT monitoring will occur following the last EzPAP® lung expansion therapy breath cycle.
~EzPAP® therapy and monitoring sessions will last about 15 minutes"
15973885|NCT03083366|Device|PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)|Bilateral s S3 sacral neuromodulation delivered via the PrimeAdvanced Surescan 97702 Neurostimulator - Medtronic (Minneapolis, MN)
15973886|NCT03083353|Drug|Isradipine|Isradipine will be administered 90 minutes prior to the initiation of cue exposure.
15973887|NCT03083353|Behavioral|Cue Exposure|Participants will be exposed to visual smoking cues (i.e., immersive 360 degree video environments) delivered through consumer VR headset and handle cigarette packs to activate and extinguish craving.
15973888|NCT03083340|Behavioral|Deprexis|Participants will complete an 8 week self-help computerized treatments through a web-based online Deprexis program.
15973889|NCT03083327|Dietary Supplement|Parenteral nutrition.|Nutrition support will be provides as per usual, but oral and enteral intake will be topped up with a standard parenteral nutrition solution. The standard parenteral nutrition solution will contain approximately 40 grams of amino acids/L, 40 g lipids/L and 100g dextrose/L).
15973890|NCT03083327|Other|Pragmatic standard care.|Nutrition support will be provided as per usual care.
15973891|NCT03083314|Procedure|SELECTIVE AXILLARY LYMPH NODE DISSECTION (SAD)|
15973892|NCT03083314|Procedure|COMPLETE AXILLARY DISSECTION (ALND)|
15973893|NCT03083301|Other|Medical Files data extraction|Medical Files data extraction
15973894|NCT03083288|Drug|[18F]FluorThanatrace|[18F]FluorThanatrace is a radiotracer for PET/CT
15973895|NCT03083275|Other|Resistance Training|
15973896|NCT03083262|Other|no intervention|None, there is no intervention
15973899|NCT03083236|Other|Enhanced|Enhanced Parent Based Intervention (EPBI)
15973900|NCT03083223|Other|position|Subjects were placed consecutively in random order in five different positions. SaO2 and vital signs were measured at each position after 10, 25, and 40 minutes.
15973901|NCT03083210|Drug|Lanreotide|Lanreotide, at a dose of 120mg subcutaneous injection every 28 days.
15973902|NCT03083197|Drug|Doxycycline 7 days|loading dose 200mg PO, then 100mg PO every 12 hours for 7 days
15973903|NCT03083197|Drug|Doxycycline 3 days|loading dose 200mg PO, then 100mg PO every 12 hours for 3 days
15973904|NCT03083197|Drug|Azithromycin 3 days|loading dose 1000mg PO on day 1, then 500mg PO every 24 hours on days 2 and 3
15973905|NCT03083184|Drug|Ethanol|An ethanol 40 % v/v - enoxaparin 1000 U/mL (Ethenox) interdialytic lock solution
15973906|NCT03083184|Drug|enoxaparin|An ethanol 40 % v/v - enoxaparin 1000 U/mL (Ethenox) interdialytic lock solution
15973907|NCT03083171|Drug|Endotoxin|At T=0 1 ng/kg E. Coli type O113 lipopolysaccharide is administrated intravenously as a bolus, followed by 1 ng/kg/hour for 3 hours.
15973908|NCT03083171|Drug|Placebo|At T=1 hour, placebo will be administered intravenously over a 1 hour period. Placebo is indistinguishable from Adrecizumab.
15973909|NCT03083171|Drug|Adrecizumab|At T=1 hour, Adrecizumab will be administered intravenously over a 1 hour period.
15973910|NCT03083158|Drug|Hepatitis B vaccine|1.0 ml (20 micrograms) suspension of hepatitis B surface antigen for intramuscular injection
15973911|NCT03083145|Dietary Supplement|Whey Protein Beverage|Beverage administered and postprandial appetite assessed for 2 hours followed by 1 hour monitoring of food intake from ad libitum snack tray.
15973912|NCT03083145|Dietary Supplement|Pea Protein Beverage|Beverage administered and postprandial appetite assessed for 2 hours followed by 1 hour monitoring of food intake from ad libitum snack tray.
15973913|NCT03083145|Behavioral|Snack Tray Choices|Items were selected from a snack tray filled with healthy and unhealthy snacks in order to determine if educational messaging influenced snack choices. Shack choices wre recorded on a check list by a third party observer.
15973916|NCT03083119|Drug|Xuesaitong soft capsule|Panax Notoginseng Saponins, Specification:0.33 per bag, once take two pills and twice a day during a month.
15973917|NCT03083119|Drug|Placebo oral capsule|Xuesaitong soft capsule Placebo, soft capsule, once take two pills and twice a day during a month.
15973918|NCT03083106|Device|Elevoplasty|The Elevo™ Kit Snoring Intervention Device is designed to facilitate deployment of the Elevo™ suture implant into the submucosal tissue of the soft palate via a minimally invasive, outpatient procedure performed by an otolaryngologist in a medical office setting.
15973919|NCT03083093|Diagnostic Test|The initial CTPA will be reviewed|The initial CTPA will be reviewed
15973920|NCT03083080|Procedure|VATS|VATS is the abbreviation of video-assisted thoracic surgery, which aims to minimize the wound for thoracic surgery and to enhance patient recovery after surgery
15973921|NCT03083080|Drug|Ropivacaine|30 mL 0.5% ropivacaine is used to achieve VATS block
15973922|NCT03083080|Drug|Epinephrine|1:400000 epinephrine is mixed with ropivacaine (local anesthetic) to reduce the risk of local anesthetic systemic toxicity
15973923|NCT03083067|Drug|Budesonide/formoterol|On the foundation of basic treatment strategies, inhaled budesonide/formoterol（160ug/4.5ug）will be used as an intervention drug for patients in PIC group. When air quality index (AQI) is above 200, they will temporary add one inhalation of budesonide/formoterol（160ug/4.5ug）twice a day until the third day after AQI drops below 200.
15973924|NCT03083067|Drug|tiotropium bromide|Inhaled tiotropium bromide(18ug) will be used as routine medicine according to doctor's advice.
15973925|NCT03083054|Biological|Autologous dendritic cells electroporated with WT1 mRNA|Production and application of autologous dendritic cells vaccines, 4 doses, biweekly
15973926|NCT03083041|Biological|SHR-1210|SHR-1210 will be administered as a 30-minute IV infusion Q2W at a dose of 200mg
15973927|NCT03083041|Drug|Apatinib|Apatinib tablet will be administered orally,once daily until progression
15973928|NCT03083028|Procedure|Non Operative|Patients who are treated non-operatively will be treated with a walking boot and allowed WBAT. Discharge from hospital will be determined by the patient walking 25m unaided by standby assistance. All patients will be reviewed between 7 and 14 days post injury with repeat x-rays by the treating surgeon.
15973929|NCT03083028|Procedure|Open reduction internal fixation of the ankl|The specific procedure for each patient managed operatively, both in the observational study and the RCT, will be determined by the operating surgeon. Any adverse intra-operative or post-operative event will be recorded. This includes but is not limited to death, infection and neurovascular injury. Post operatively, all patients will be NWB (non weight bearing) and placed in a POP (plaster of paris) below knee cast or walking boot. Discharge from hospital will be determined by the patient walking 25m unaided by standby assistance. The treating surgeon will review the patients after 10-14 days for a wound review, removal of sutures and change of cast to a fibreglass cast or walking boot (cam walker). The patient will be WBAT (weight bearing as tolerated) for a further 4 weeks.
15973930|NCT03083015|Procedure|revascularization|a sterile sharp needle was used to irritate the apical tissue until bleeding occurred apically in the root canal space so as to create a biological scaffold for the regenerative process
15973931|NCT03083015|Procedure|Apexification|a 3-5 mm thickness of MTA using a hand plugger and was verified radiographically.
15973932|NCT03082989|Device|fractional flow reserve performed|assessing fractional flow reserve to drive revascularization
15973933|NCT03082989|Other|fractional flow reserve not performed|description of the main reasons leading the operator to not use fractional flow reserve to drive the coronary revascularization
15973934|NCT03082963|Device|Electrogram Morphology Mapping (EMR)|Fifteen second AF recordings will be made using a multipolar electrode catheter to map the entire right atrium & then the left atrium.
15973935|NCT03082950|Diagnostic Test|polymerase chain reaction|PCR is performed with all patients. The result (hpv positive or negative) will define the patiens Group Affiliation.
15973936|NCT03082937|Drug|3 mg [14C]-A4250 capsule|Each subject will receive a single administration of 3 mg [14C]-A4250 capsule for oral administration containing not more than 4.3 MBq (116 μCi), in the fasted state.
15973937|NCT03082924|Device|Control group|Neither cycle training nor inspiratory muscle training.
15973938|NCT03082924|Device|Calibrated cycle ergometer|The most common device to perform cycle training is calibrated cycle ergometer.
15973939|NCT03082924|Device|Threshold loading device|Threshold loading device is used to perform inspiratory muscle training.
15973940|NCT03082924|Device|Calibrated cycle ergometer and threshold loading device|Combined cycle training and inspiratory muscle training.The threshold loading device is composed of a mouth -piece attached to a small plastic cylinder that contains a spring-loaded poppet value. The valve opens to permit inspiratory flow only once the person has generated adequate negative intrathoracic pressure to condense the spring.
15973941|NCT03082911|Other|Phone call|"A brief telephone intervention at the same time of sending the invitation letter plus the habitual invitation process used in the screening program (described in control group). Each phone call will last approximately 5 minutes.
~Calls will be made by the administrative staff of the Screening Technical Office, which is experienced in telephone attention."
15973942|NCT03082911|Other|Invitation letter|The habitual invitation strategy used in the screening program . Three letters are send by post: 1- An invitation letter plus an information leaflet and a list of pharmacies in which people can obtain the screening test. 2- A reminder letter for those who have not participated after 5 weeks of sending the first letter. 3- A second reminder letter for those who have collected the kit in the pharmacy but have not returned it with the sample
15973943|NCT03082898|Device|Indego Exoskeleton|Regular dosing of Indego Exoskeleton walking.
15973944|NCT03082885|Drug|Thymosin-α1|1.6 mg s.c injection once per day for 7 days, then 1.6 mg s.c injection twice a week for 11 weeks.
15973945|NCT03082872|Device|Cemented K-wire|Fracture of proximal phalanx was treated with Cemented K-wire.
15973946|NCT03082872|Device|Transfixion Pinning|Fracture of proximal phalanx was treated with transfixion pinning.
15973947|NCT03082859|Behavioral|Exercise|This a randomised cross-over study involving three different modes of exercise which will be compared to a no-exercise control.
15973948|NCT03082846|Radiation|hypofractionated radiation|The simultaneous integrated boost-intensity modulated technology is adopted to increase both the dose in the surgical cavity and residual tumor (PTV1).The dose at each fraction is gradually increased from 2.8 Gy/f (total of 20 times) with an escalating dose interval of 0.4 Gy in PTV1, until dose-limiting toxicity is present,the highest target single dose is 4 Gy/f. The planning target volume (PTV2) including the 2 cm region around surgical cavity and residual tumor remain unchanged, with 2.5 Gy each time and a total of 50 Gy/20f.
15973949|NCT03082846|Drug|Temozolomide chemotherapy|Temozolomide(TMZ) is administered orally every day at 75 mg/m2 during radiotherapy and at 150-200 mg/m2 for 12 cycles following completion of chemoradiotherapy.
15973950|NCT03082833|Drug|AZD2014|AZD2014 is a selective dual mTOR kinase inhibitor targeting both mTORC1 (rapamycin sensitive) and mTORC2 (rapamycin insensitive) complexes of mammalian Target Of Rapamycin (mTOR).
15973951|NCT03082820|Diagnostic Test|Pain-related evoked potentials (PREP)|PREP were performed bilaterally with a concentric surface electrode at twice the individual pain threshold.
15973952|NCT03082820|Diagnostic Test|Quantitative Sensory Testing (QST)|QST was performed bilaterally following the protocol of the German Network on Neuropathic Pain.
15973953|NCT03082820|Diagnostic Test|Nerve conduction studies (NCS)|NCS were performed with patients only.
15973954|NCT03082807|Dietary Supplement|NCDsport|Negative Calorie Diet supplemented with exercise
15973955|NCT03082807|Dietary Supplement|LCDsport|Low-Calorie diet with exercise
15973956|NCT03082794|Dietary Supplement|NCD|Negative Calorie Diet
15973957|NCT03082794|Dietary Supplement|LCD|Low Calorie Diet
15973958|NCT03082781|Dietary Supplement|NCDsport|Negative Calorie Diet supplemented with exercise
15973959|NCT03082781|Dietary Supplement|LCDsport|Low-Calorie diet with exercise
15973960|NCT03082768|Drug|[18F]MNI-968|Healthy volunteers recruited for the study will undergo two [18F]MNI-968 injections and PET scans.
15973961|NCT03082755|Drug|Gabapentin Enacarbil|1 to 2 GEn tablets (300 milligrams per tablet) will be administered once a day in the evening (about 5pm) for 8 weeks.
15973962|NCT03082755|Drug|Placebo Oral Tablet|1 to 2 Placebo Oral Tablets will be administered once a day in the evening (about 5pm) for 8 weeks.
15973963|NCT03082742|Drug|Hydrochlorothiazide|
15973964|NCT03082742|Drug|Furosemide|
15973965|NCT03082729|Drug|Apremilast|Apremilast (brand name Otezla) is a medication for the treatment of certain types of psoriasis and psoriatic arthritis.
15973966|NCT03082716|Drug|Custodiol Solution|After cross clamping patient will receive single dose of HTK custodiol cardioplegia. at temperature of 4-8°C and will be perfused for 6-8 minutes. Dose will start from 400 up to 1000 ml according to the child's body weight. Perfusion pressure will be kept at 70 - 80 mmHg until the heart is arrested.
15973967|NCT03082716|Drug|Blood cardioplegia|After cross clamping patient will receive blood cardioplegia, delivered by microplegia delivery system by adding potassium to the blood (K= 35 ml eq/L) . The initial dose will be 35ml/ kg, and subsequent doses 20-15 ml/kg given every 20 minutes at a Temperature of 10 - 15 °C, while maintaining a perfusion pressure of 100-125 mmHg.
15973968|NCT03082703|Behavioral|Text Messaging|Subjects contacted 3 times weekly via text messaging for the study period.
15973969|NCT03082690|Drug|DuoGel|1% IQP-0528 in gel formulation
15973970|NCT03082677|Drug|Ixazomib|Ixazomib beginning between day +100 to +150 at a dose of 4 mg orally once per week (3 weeks on/ 1 week off).
15973971|NCT03082664|Device|PICO Single Use Negative Pressure Wound Therapy|The PICO device will be placed over the closed cesarean section incision.
15973972|NCT03082651|Other|Alternating run training load|Runners will perform a variation of workouts, consisting of interval/speed work, tempo runs, and long-slow distance runs throughout each 7-day period
15973973|NCT03082651|Other|Alternating footwear|Runners will be assigned identical training sessions over a 7-day period but will alternate use of two different models of running shoes across successive workouts (Nike Pegasus and Nike Zoom Streak). The Zoom Streak has 10mm less midsole material, a less supportive heel counter and more flexible forefoot providing a more responsive feel to the runner.
15973974|NCT03082651|Other|Constant training|Runners will be assigned identical training sessions over a 7-day period.
15973975|NCT03082651|Other|Constant footwear|Runners perform runs in two pairs of the same assigned neutral-cushioned running shoe (Nike Pegasus).
15973976|NCT03082625|Drug|Transdermal Magnesium|Magnesium
15973977|NCT03082625|Drug|Placebo|
15973978|NCT03082612|Behavioral|Overcoming Psychological Distress through Hymns Intervention|The intervention will consist of participants viewing a selection of video recorded vignettes during 3 weekly sessions. There will be 5 vignettes included in each session with each vignette edited to a real time of 3-4 minutes (each session is 30 minutes). Since the intervention is designed to be self-administered, there will be a video recorded introduction and instructions for use narrated by the PI. The vignettes are of actual African American cancer survivors narrating stories of ways in which hymns can be used to overcome their anxieties and depressed moods through the use of a hymn. The hymns included represent exemplars from the 5 themes prevalent in the PI's previous research
15973979|NCT03082612|Behavioral|Usual care|Usual care includes education to increase cancer knowledge, treatment coaches, and psychological services.
15973980|NCT03082599|Device|Presbyopia and astigmatism correcting intraocular lens|The Symfony Toric IOL (ZXTx) is an extended depth of focus (EDOF) IOL design to improve the sharpness of vision at near, intermediate and far distances reducing the need of glasses after cataract surgery in patients with astigmatism.
15973981|NCT03082586|Radiation|radiochemotherapy 1|concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 7.2 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2, weekly; paclitaxel, 45-50 mg/m2, weekly
15973982|NCT03082586|Radiation|radiochemotherapy 2|concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 14.4 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
15973983|NCT03082586|Radiation|radiochemotherapy 3|concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 21.6 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
15973984|NCT03082586|Radiation|radiochemotherapy 4|concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 28.8 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
15973985|NCT03082586|Radiation|radiochemotherapy 5|concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 36 Gy at 1.2 Gy/Fx/bid; concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly;
15973986|NCT03082586|Radiation|radiochemotherapy 6|concurrent radiochemotherapy: radiotherapy dose level 1: 50 Gy at 2 Gy/Fx/d, then 43.2 Gy at 1.2 Gy/Fx/bid concurrent chemotherapy: carboplatin, area under the curve (AUC) 1.5-2,weekly; paclitaxel, 45-50 mg/m2, weekly
15973987|NCT03082573|Drug|H.P. Acthar gel|H.P. Acthar gel in treatment of Refractory RA
15973988|NCT03082560|Diagnostic Test|Boston Grade of Activity in Lichen Planopilaris|A clinical assessment tool to objectively and accurately measure activity and severity in lichen planopilaris over time.
15973989|NCT03082534|Drug|Pembrolizumab, Cetuximab|"Pembrolizumab (KEYTRUDA®; MK-3475) is a potent and highly selective humanized monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/kappa isotype designed to directly block the interaction between PD-1 and its ligands, programmed cell death ligand 1 (PD-L1) and programmed cell death ligand 2 (PD-L2). This blockade enhances functional activity of the target lymphocytes to facilitate tumor regression and ultimately immune rejection.
~Cetuximab (Erbitux®) binds specifically to the epidermal growth factor receptor (EGFR) on both normal and tumor cells, and competitively inhibits the binding of EGF and other ligands, such as transforming growth factor-alpha. Cetuximab can mediate antibody-dependent cellular cytotoxicity (ADCC), with in vitro assays and in vivo animal studies demonstrating that cetuximab inhibits the growth and survival of tumor cells expressing EGFR."
15973990|NCT03082521|Behavioral|Improving the antibiotic prescribing quality|The goal is to improve the antibiotic prescribing quality of GPs in a GPC by setting up a participatory action research. The interventions will be co-designed with the GPs.
15973991|NCT03082508|Device|Algisyl|Algisyl device (implants) administered during a surgical procedure
15973992|NCT03082508|Drug|Standard Medical Therapy|as per protocol
15973993|NCT03082495|Behavioral|Exercise|Supervised high-intensity interval training (HIIT) during NACRT followed by unsupervised moderate-to-vigorous intensity continuous exercise training after the completion of NACRT and before surgery
15973994|NCT03082482|Behavioral|Self-help materials|Self-help smoking cessation materials
15973995|NCT03082482|Drug|nicotine patch|Participants who smoke >10 cigarettes per day will receive 4 weeks of 21 mg, 2 weeks of 14 mg, and 2 weeks of 7 mg nicotine patches. Participants who smoke <10 cigarettes per day will receive 6 weeks of 14 mg and 2 weeks of 7 mg nicotine patches.
15973996|NCT03082482|Behavioral|Counseling|Proactive phone counseling with a Certified Tobacco Treatment Counselor
15973997|NCT03082482|Other|Smartphone-delivered automated treatment|Tailored video clips, text and graphical messages delivered automatically each week to the participant.
15973998|NCT03082469|Device|CytoSorb|Two consecutive 24h treatments with the CytoSorb-device
15973999|NCT03082456|Diagnostic Test|Molecular breast imaging|Molecular breast imaging will be performed at 5-10 minutes after intravenous injection of 15-20 millicurie (mCi) Tc-99m sestamibi. Both craniocaudal (CC) view and mediolateral oblique (MLO) images of the breast are taken.
15974000|NCT03082456|Diagnostic Test|Mammography|During the procedure, the breast is compressed using a dedicated mammography unit. Parallel-plate compression evens out the thickness of breast tissue to increase image quality by reducing the thickness of tissue that x-rays must penetrate, decreasing the amount of scattered radiation, reducing the required radiation dose, and holding the breast still (preventing motion blur). Both craniocaudal (CC) view and mediolateral oblique (MLO) images of the breast are taken.
15974001|NCT03082456|Diagnostic Test|Breast ultrasound|Ultrasound investigation of breast is performed by members of breast cancer team. If abnormality is found by the procedure, biopsy will not be performed directly.
15974035|NCT03082144|Radiation|Radiotherapy|The sites of symptomatic disease, bulky disease observed on MRI, including the whole brain and basis cranii, 40 Gy in 20 fractions;and/or segment of spinal canal received 40-50 Gy in 20-25 fractions.
15974036|NCT03082131|Dietary Supplement|Resistant Starch Wheat|The investigators will be testing high amylose wheat varieties developed by Arcadia Biosciences that have high levels of RS in the endosperm, the source of refined flour. Compared to regular wheat varieties with RS levels of less than 1%, Arcadia's wheat varieties contain between 16% and 34% RS.
15974037|NCT03082118|Device|Vesair Bladder Control System|Intravesical balloon
15974038|NCT03082105|Other|Breathing in snow|Breathing in snow with different physical properties
15974002|NCT03082443|Other|Therapeutic group|"The group will take place in six meetings lasting one hour. At the end of the intervention, a new group will be started.
~Issues related to illness, cardiopulmonary rehabilitation, aroused feelings and aspects of food education will be addressed, with the objective of improving nutritional profile, quality of life and reduction of stress level. During the meeting they will be constantly encouraged to express their feelings, doubts and exchanges of experiences.
~In the first individual care (both groups) an initial consultation will be performed when the sociodemographic and anthropometric data will be collected and the instruments will be applied: Lipp Adult Stress Inventory, SF-12 Quality of Life Assessment Questionnaire and Questionnaire Of Food Frequency. After three months, all participants will be reassessed by the psychologist and nutritionist and anthropometric data will be collected and the instruments applied again."
15974003|NCT03082430|Biological|autologous PRP.|one autologous PRP patient in this study and monitor and follow the evolution of pain and the knee function
15974004|NCT03082417|Other|Implementation|"The PAINFREE Initiative is a Multifaceted intervention:
~Educating and providing point-of-care tools to nurses working at Emergency Department to improve pain management in older adults with fractures
~Educating and providing point of care tools to Emergency Departments physicians working at Emergency Department to improve pain management in older adults with fractures
~Inform the patients and their family about how to better manage the pain after a fracture"
15974005|NCT03082404|Other|Inspiratory muscle training|Inspiratory muscle training will be performed during the first hour of hemodialysis treatment and the protocol will consist of five series with 10 repetitions, each series with a two-minute interval of according to patient tolerance. The overload will be adjusted weekly, beginning with 50% of the maximum inspiratory pressure, during the first week, 60% of maximum inspiratory pressure in the second and third week and 70% of maximum inspiratory pressure in the fourth and fifth weeks. Maximum inspiratory pressure will be evaluated before the protocol period and adjusted weekly by manovacuometry.
15974006|NCT03082391|Device|Heavyweight Mesh|Patients will undergo ventral hernia repair with heavweight mesh.
15974007|NCT03082391|Device|Mediumweight Mesh|Patients will undergo ventral hernia repair with mediumweight mesh.
15974008|NCT03082352|Drug|BF-Metoprolol Tablet 100mg|BF-Metoprolol Tablet 100mg is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
15974009|NCT03082352|Drug|Betaloc Tablet 100mg|Betaloc Tablet 100mg will be used as a comparator drug for the BE study
15974010|NCT03082339|Other|Cortisone|Observation of QTc-interval
15974011|NCT03082313|Behavioral|Movement Intervention|At each visit, the caregiver will be reminded of the infant's movement rate and proportion of unilateral and bilateral movements from the last visit. The research team will help the caregiver to determine possible ways to achieve the goal of 1200 movements per hour of awake time, with 1/3 single leg movements and 2/3 bilateral leg movements. Strategies to increase leg movements will be encouraged based on the infant's developmental level and what they demonstrate a response to, including: shake a toy when infant moves legs, sing a line of a song when infant moves legs, change the position of the infant to encourage more leg movement, or lightly tickle the legs and feet of the infant. The intervention will use the GAME (Goals - Activity - Motor Enrichment) protocol, a motor learning, environmental enrichment intervention that has recently been shown to be effective for improving motor skills in infants at high risk of cerebral palsy compared to standard care.
15974012|NCT03082300|Drug|naquotinib|Oral
15974013|NCT03082287|Device|Fecal Calprotectin Level|Measurement of calprotectin in feces
15974014|NCT03082274|Diagnostic Test|ConfirmMDx|ConfirmMDx is a molecular diagnostic assay which utilizes DNA isolated from biopsy tissues to determine if aberrant DNA methylation is occurring in three genes: GSTP1, RASSF1 and APC. ConfirmMDx is currently available to clinicians for use in cancer-negative extended-core biopsies to determine if occult cancer is present in the prostate.
15974015|NCT03082274|Diagnostic Test|SelectMDx|SelectMDx for Prostate Cancer is a reverse-transcription PCR (RT-PCR) assay performed on post-DRE, first-void urine specimens from patients with clinical risk factors for prostate cancer, who are being considered for biopsy. The test measures the mRNA levels of the DLX1 and HOXC6 biomarkers, using KLK3 as internal reference gene, to aid in patient selection for prostate biopsy.
15974016|NCT03082261|Device|Prodigy, Prodigy MRI or Proclaim Elite IPG|Subjects will be permanently implanted with either a Prodigy, Prodigy MRI or Proclaim Elite IPG
15974017|NCT03082248|Other|Physical Therapy|Patients allocated to the conservative treatment group will receive physical therapy according to the treatment-based classification approach and also educational leaflets and folders.
15974018|NCT03082248|Procedure|Spinal Surgery|Patients allocated to the surgical procedure group will undergo spinal surgery procedures and techniques specific for the low back region.
15974019|NCT03082235|Drug|E6742|gelatin capsules
15974020|NCT03082235|Drug|Placebo|gelatin capsules
15974025|NCT03082196|Drug|Test varnish|Topical application of test varnish to the teeth 4 times per year.
15974026|NCT03082196|Drug|Standard varnish|Topical application of test varnish to the teeth 4 times per year
15974027|NCT03082183|Drug|Rifampicin|once daily
15974028|NCT03082183|Drug|BI 425809|once daily
15974029|NCT03082170|Device|FEES|FEES test. During this test the investigators look at the pharynx and larynx of the participant while he eats and drinks Economy using number of textures aim to identify swallowing pathology.
15974030|NCT03082170|Diagnostic Test|SDQ|The participant will fill a questionnaire containing 14 questions.These Questions rigorously test all aspects of the swallowing. High score in this test is consistent with swallowing disorder.
15974031|NCT03082170|Behavioral|data review|Reviewing the data from the test summary of participants who have already undergone post operative swallowing assessment.
15974032|NCT03082157|Behavioral|Mighty Men Intervention|African American men assigned to this condition will receive: tailored goals/ messages, self-monitoring, small group meetings and educational and community-based information and resources.
15974033|NCT03082144|Drug|MTX|MTX 15 mg,via lumbar puncture,once per week, 4 weeks in total
15974034|NCT03082144|Drug|Ara-C|Ara-C 50mg,via lumbar puncture,once per week, 4 weeks in total
15974039|NCT03082092|Drug|Methylprednisolone Sodium Succinate|single intravenous dose of 125mg methylprednisolone diluted in 2.1ml of diluent given on induction of total knee replacement
15974040|NCT03082092|Drug|Placebos|0.9% intravenous saline (2.1ml) intravenously on induction of total knee replacement
15974041|NCT03082079|Procedure|ESD|Patient in ESD group undergo ESD for GIST, and regular follow-up are carried out for these patients on 72 ±3h,7±2d,14±2d,3 month,6 month,1 year,2 year,3 year,4 year,5 year after the treatment. The investigators record the success rate of operation,en bloc resection,operation time,complication rate,hospitalization days,hospitalization expenses,pathology results and tumor recurrence rate
15974042|NCT03082066|Other|CT or MRI scan|CT or MRI performed for underlying disease. CT and MRI scans used to asses bone and soft tissue diameter
15974043|NCT03082053|Drug|varlitinib|IMP
15974044|NCT03082053|Drug|capecitabine|Companion Medication
15974045|NCT03082040|Behavioral|home-based breathing training|The intervention group will undergo a home-based breathing training 20 minutes twice daily for four weeks. Participants in the control condition will participate the same breathing training after a four-week waiting list period.
15974046|NCT03082027|Diagnostic Test|ultrasonography|ultrasonography of median nerve
15974047|NCT03082014|Drug|Amlodipine|blood pressure lowering agent - dihydropyridine Ca2+-channel blocker
15974048|NCT03082014|Drug|Losartan|blood pressure lowering agent - angiotensin-receptor blockers
15974049|NCT03082014|Drug|Atenolol|blood pressure lowering agent - beta-blocker
15974050|NCT03082001|Drug|12% Sucrose|
15974051|NCT03082001|Drug|24% Sucrose|
15974052|NCT03081988|Other|chemoradiotherapy|concomitant chemoradiotherpay is routine treatment in locally advanced and advanced esophageal cancer and it is not for research.
15974053|NCT03081975|Device|HD white light or NBI|Use of NBI or HD white light
15974054|NCT03081962|Drug|Bundle|Combination of antibiotic intraperitoneal irrigation with gentamicin and clindamycin solution, use of Triclosan-impregnated sutures and mupirocin application over the skin staples.
15974055|NCT03081962|Procedure|Standard care|Standard care measures include decontamination of the skin during surgery with chlorhexidine alcohol solution, administration of systemic antibiotic prophylaxis and application of thermal blanket to avoid hypothermia. In the standard care protocol, the fascial closure will be performed with a polyglactin suture (without Triclosan impregnation).
15974056|NCT03081949|Drug|Oral Sodium Selenite 200 µg/day for 3 months|PPCM patients with selenium deficiency, who have not achieved LV reverse remodelling (LVRR) (LV end-diastolic dimension indexed to body surface area (LVEDDi) ≤33.0 mm/m2) at 6 months after diagnosis.
15974057|NCT03081936|Dietary Supplement|Oral consumption of Nutricia Aptamil Stage 1 formula|Daily oral consumption of Nutricia Aptamil Stage 1 formula
15974058|NCT03081936|Dietary Supplement|Oral consumption of a2® Platinum Stage 1 formula|Daily oral consumption of a2® Platinum Stage 1 formula
15974059|NCT03081936|Dietary Supplement|Oral consumption of breast milk|Daily oral consumption of breast milk
15974060|NCT03081923|Drug|Durvalumab|anti-PD-L1 mono therapy
15974061|NCT03081923|Drug|Tremelimumab|anti-CTLA4 drug Tremelimumab mono therapy
15974062|NCT03081910|Genetic|Autologous CD5.CAR/28zeta CAR T cells|"Three dose levels will be evaluated:
~Dose level one: 1×10^7 cells/m2
~Dose level two: 5×10^7 cells/m2
~Dose level three: 1×10^8 cells/m2
~The first six (6) patients treated on the study will be adults (>18 yrs of age).
~The T cells will be administered with Cytoxan and fludarabine."
15974063|NCT03081910|Drug|Fludarabine|Patients will receive 3 daily doses of fludarabine (30 mg/m2) to induce lymphopenia, finishing at least 24 hours before T cell infusion. Infusions should be given following hospital/pharmacy recommendations (including dose adjustments as appropriate per institutional guidelines) however at a minimum the fludarabine should be infused over 30 minutes. Mesna, IV hydration and anti-emetics should also be provided following local institutional guidelines.
15974064|NCT03081910|Drug|Cytoxan|Patients will receive 3 daily doses of cyclophosphamide (500 mg/m2/day) to induce lymphopenia, finishing at least 24 hours before T cell infusion. Infusions should be given following hospital/pharmacy recommendations (including dose adjustments as appropriate per institutional guidelines) however at a minimum the cyclophosphamide should be infused over 1 hour. Mesna, IV hydration and anti-emetics should also be provided following local institutional guidelines.
15974065|NCT03081910|Genetic|Allogeneic CD5.CAR/28zeta CAR T cells|"Three dose levels will be evaluated:
~Dose level one: 1×10^7 cells/m2
~Dose level two: 5×10^7 cells/m2
~Dose level three: 1×10^8 cells/m2
~The first six (6) patients treated on the study will be adults (>18 yrs of age)
~The T cells will be administered with Cytoxan and fludarabine."
15974066|NCT03081897|Drug|SPRANC Block group|General anaesthesia with Propofol (2mg/kgKG) and Remifentanil (0,1-0,4 µg/kg/min); additional regional anaesthesia (cervical plexus block) with an long acting local anesthetic according to clinical estimation of the treating anesthetist (about 15 ml Ropivacaine 0,75% around the carotid bifurcation, 5 ml Ropivacaine in the region of Erb´s Point of the superficial cervical plexus and 10 ml Ropivacaine at the area of skin incision on the tumor side); unilateral neck dissection.
15974067|NCT03081897|Drug|SPRANC Control group|General anaesthesia with Propofol (2mg/kgKG) and Remifentanil (0,1-0,4 µg/kg/min); additional regional Patient Control Group (no Intervention planned), general anaesthesia with Propofol (2mg/kgKG) and Remifentanil (0,1-0,4 µg/kg/min); unilateral neck dissection.
15974068|NCT03081884|Drug|FACBC PET-CT Imaging|"Participants will fast for 4 hours to normalize their neutral amino acid levels. One hour prior to the scan, participants will drink up to 450ml of standard oral contrast. Participants will lie on the scanning bed while the bed moves through the PET/CT scanner for the CT portion of the exam. After completion of the CT scan, approximately 10 units of FACBC will be injected for the PET scan portion of the exam. The bed will move through the scanner again and the PET portion of the exam will take 30 minutes. The entire visit will take about two hours.
~Standard of care procedures include conventional imaging (CT and/or MRI; bone scan and/or NaF PET per institutional standards) and radical prostatectomy with extended pelvic lymph node dissection."
15974107|NCT03081533|Other|Circle Dance Program (CircleCare)|Circle Dances derives from folk dances, but their current repertoire encompasses traditional and contemporary dances from diverse nations and cultures around the world. Most of the choreographies are danced with the participants placed in a circle, holding hands, repeating a pattern of steps to the rhythm of the music.
15974141|NCT03081247|Drug|BFF 320/9.6 µg|Budesonide and Formoterol Fumarate metered dose inhaler (BFF MDI)
15974069|NCT03081871|Other|Pharmacist-led cardiovascular risk service (CVRS)|CVRS pharmacists will access the study database including patient baseline information obtained from the medical record and patient entered data to make their assessments and recommendations to onsite physicians and onsite clinical pharmacists and individualize their communication with patients. The intervention will provide patient-centered counseling and education to improve medication adherence, lifestyle modifications and/or smoking cessation. The CVRS pharmacist does not make changes to therapy independently but, rather, provides the physicians and on-site pharmacists with action plans and status updates about adherence to Guideline metrics, which should markedly reduce the gaps in guideline-concordant therapy that place patients at risk for CVD events.
15974070|NCT03081871|Other|Mobile access to study Personal Health Record|Only subjects assigned to the intervention arm will have access to the mobile app version of the study personal Health Record.
15974071|NCT03081871|Other|Web access to study Personal Health Record|Subjects assigned to both the intervention and control arms will have access to the standard website version of the study personal Health Record.
15974072|NCT03081858|Drug|TSD-001|Administered via intravesical instillation.
15974073|NCT03081845|Dietary Supplement|Oral consumption of milk A1 in study phase 1|Oral consumption of 250 ml of milk containing both A1 and A2 type beta casein 2 times per day after meal for 5 days in study phase 1.
15974074|NCT03081845|Dietary Supplement|Oral consumption of milk A2 in study phase 1|Oral consumption of 250 ml of milk containing only A2 type beta casein 2 times per day after meal for 5 days in study phase 1.
15974075|NCT03081845|Dietary Supplement|Oral consumption of milk A1 in study phase 2|Oral consumption of 250 ml of milk containing both A1 and A2 type beta casein 2 times per day after meal for 5 days in study phase 2.
15974076|NCT03081845|Dietary Supplement|Oral consumption of milk A2 in study phase 2|Oral consumption of 250 ml of milk containing only A2 type beta casein 2 times per day after meal for 5 days in study phase 2.
15974077|NCT03081832|Drug|Oxytocin|Infant included in the ancient study (repeated administrations of oxytocin in infants with Prader Willi Syndrome aged from 0 to 6 months)
15974078|NCT03081832|Other|Control|Not treated.
15974079|NCT03081819|Drug|SH003|Herbal medicine for cancer treatment
15974081|NCT03081780|Biological|FATE-NK100|"Preparative regimen:
~Fludarabine 25 mg/m2 x 5 days start Day -6
~Cyclophosphamide 60 mg/kg x 2 days on Day -5 and -4
~Apheresis cell collection (collected from the Donor Day - 8) will be enriched for FATE-NK100 per CMC. IL-2 at 6 million IU subcutaneously (SC) every other day (EOD) for 6 doses with Dose 1 on Day 0 (no sooner than 4 hours post NK cells) and last dose no later than Day +12."
15974082|NCT03081767|Diagnostic Test|Digital PET/CT scan|The Division of Nuclear Medicine and Molecular Imaging at Stanford has installed the first ever GE-made digital PET/CT scanner worldwide. The investigators wish to determine if the digital PET/CT scanner offers equivalent image quality as the standard PET/CT scanner.
15974083|NCT03081754|Radiation|Doppler velocimetry|Doppler studies were performed within the last week before delivery using a 3.5-Mhz transducer, all measurements were performed with the mothers in a semi recumbent position. Color-flow imaging was used to visualize the ascending branch of the uterine arteries. Pulsed Doppler velocimetry was performed with a sample volume of 5 mm.
15974084|NCT03081728|Device|Interscalene Block with Ropivacaine Hcl 0.2% Inj Vil 10Ml|bolus 10ml of 0.5% ropivacaine followed by infusion @ 2ml/hr of 0.2% ropivacaine
15974085|NCT03081728|Drug|IV diclofenac and IV paracetamol|iv diclofenac 75 mg TDS iv paracetamol 1gm TDS
15974086|NCT03081715|Other|PD-1 Knockout T Cells|Programmed cell death 1(PD-1) gene will be knocked out by CRISPR Cas9
15974087|NCT03081702|Drug|Hydroxychloroquine|Hydroxychloroquine is approved/used for the treatment of rheumatoid arthritis, and discoid and systemic lupus erythematosus, as well as suppressive treatment and treatment of acute attacks of malaria.
15974088|NCT03081702|Drug|Itraconazole|Itraconazole is approved and used for the treatment of certain systemic fungal infections.
15974089|NCT03081689|Drug|Nivolumab 360 mg|Nivolumab 360 mg IV Q3W + Followed by adjuvant treatment for 1 year with Nivolumab 240 mg IV Q2W for 4 months and Nivolumab 480mg Q4W for 8 months
15974090|NCT03081689|Drug|Paclitaxel 200mg/m2|Paclitaxel 200mg/m2 IV Q3W
15974091|NCT03081689|Drug|Carboplatin AUC 6|Carboplatin AUC 6 IV Q3W
15974092|NCT03081676|Drug|Glimepiride 1Mg Tablet|Glimepiride
15974093|NCT03081676|Drug|Glucagon-like Peptide-1|GLP-1 infusion
15974094|NCT03081676|Drug|Glucose-Dependent Insulinotropic Polypeptide|GIP-infusion
15974095|NCT03081676|Drug|Placebo Oral Tablet|Placebo
15974096|NCT03081676|Drug|Placebo infusion|Placebo (saline)
15974097|NCT03081663|Procedure|Quads-Sparing Approach|Quadriceps-sparing mid-vastus approach for total knee arthroplasty
15974098|NCT03081663|Procedure|Medial Para-Patellar Approach|Medial para-patellar approach for total knee arthroplasty
15974099|NCT03081650|Device|Airvo Humidifier|
15974100|NCT03081611|Device|Ram cannula|Ventilatory support for preterm infants using Ram cannula
15974101|NCT03081611|Device|Short nasal prongs|Ventilatory support for preterm infants using short nasal prongs
15974102|NCT03081598|Drug|PBI-4050|Soft gelatine capsule containing 200 mg of the active ingredient per capsule
15974103|NCT03081598|Other|Placebo|Placebo soft gelatine capsule
15974104|NCT03081585|Behavioral|Satiety State|Participants were scanned twice: once after a meal and once after fasting for 24 hours
15974105|NCT03081572|Diagnostic Test|Platelet aggregation|Platelet aggregation
15974106|NCT03081559|Behavioral|Healthy Divas|Peer-based counseling to improve medication adherence and engagement in care
15974108|NCT03081520|Behavioral|Affective response MIT|Examine acute affective responses during and after five sessions of endurance training with moderate intensity continuous training
15974212|NCT03080675|Dietary Supplement|Nutrional blend of ingredients including vitamins and fish oil|
15974109|NCT03081520|Behavioral|Affective response HAIT|Examine acute affective responses during and after five sessions of endurance training with high-intensity aerobic interval training
15974110|NCT03081520|Behavioral|Affective response HIIT|Examine acute affective responses during and after five sessions of endurance training with high-intensity sprint interval training
15974111|NCT03081507|Behavioral|SM-LHW|Will not receive additional follow-up from the LHW, but will be encouraged during the session to make an appointment with their provider to schedule a mammogram and Pap test, or to consult the MARHABA webpage for information on low-cost and culturally appropriate referral sources of screening. Individuals assigned to this arm who did not attend an educational seminar will be mailed a packet containing a palm card, brochure, and letter encouraging them to speak with their provider about breast and cervical cancer screening and/or going to the MARHABA webpage. LHWs will complete a follow-up survey with participants by phone or in-person at 4 months after baseline
15974112|NCT03081507|Behavioral|PN-LHW|PNLHW participants will receive three planned contacts with LHWs that focus on navigation for obtaining mammogram and/or Pap testing.The initial contact will be made by phone and will focus on motivating participants to make an appointment with their primary care provider and/or obstetrician/gynecologist (OB/GYN), as well as provide information on low-cost or free care if necessary. The second contact will discuss the process of going to the appointment and the third contact will focus on the process of obtaining and interpreting. The second and third contacts will be either made by phone or in-person, depending on participant needs.
15974113|NCT03081494|Drug|spartalizumab (PDR001)|100 mg lyophilisate in vial received 400 mg every 4 weeks
15974114|NCT03081494|Drug|regorafenib|120 mg once daily first 21 days of each 28-day cycle (=4 weeks)
15974115|NCT03081481|Drug|PRX302|Single prostate cancer lesion injected with PRX302
15974116|NCT03081468|Device|Binocular OCT prototype|Participants in the study will undergo pupil measurement using a prototype binocular OCT imaging system (Envision Diagnostics, Inc., CA). For the binocular OCT imaging system, testing will be performed twice in the same session, by the same examiner, to allow assessment of repeatability (test-retest variability).
15974117|NCT03081468|Device|Konan RAPDx|Participants in the study will undergo pupil measurement using a validated, commercially available pupilometer (RAPDx; Konan Medical USA, Inc., Irvine, CA).
15974118|NCT03081455|Diagnostic Test|Diagnostic Test|Genetic Diagnostic Testing
15974119|NCT03081442|Drug|Misoprostol|600 micrograms of misoprostol vaginally as deep as possible six hours before IUD insertion
15974120|NCT03081442|Device|Intrauterine contraceptive device IUCD|"bimanual examination. The cervix was exposed by introducing a vaginal speculum, the cervix and vaginal vault were cleaned with povidone- iodine solution.
~The Next step was to sound The IUD was folded into the insertion tube immediately prior to insertion. The cervix was grasped with a tenaculum, and gently pulled downward The insertion tube was advanced into the uterus to the correct depth as marked on the tube by a sliding plastic flange.
~The outer sheath of the insert was withdrawn ashort distance to release the arms of the T and was then gently pushed inward again to elevate the opened T against the fundus of uterus ."
15974121|NCT03081416|Drug|Ketamine|Intranasal ketamine administration
15974122|NCT03081416|Drug|Normal saline|
15974123|NCT03081416|Drug|Metoclopramide|Standard therapy
15974124|NCT03081416|Drug|Ketorolac|standard therapy
15974125|NCT03081416|Drug|Dexamethasone|Standard therapy
15974126|NCT03081416|Drug|Benadryl|Standard therapy
15974127|NCT03081403|Device|Quantitative Sensory Testing|Study of detection thresholds of vibration, cold and pain related to the heat in the dominant hand of the subjects through the QST.
15974128|NCT03081390|Other|Mixed meal tolerance testing|An intravenous catheter is placed for serial blood draws for inflammatory markers and ancillary studies. The participant consumes a test meal, and measurements are made for 4 hours.
15974129|NCT03081390|Other|Skin conductance & cold pressor test|Skin conductance will be monitored continuously with 2 electrodes placed on the plantar surface of the foot. To induce pain, we will use the cold pressor test. Participants submerge one hand in a bath with iced water (2-4ºC) for 2 minutes. Blood pressure and heart rate are monitored every minute starting 5 minutes before the cold pressor test and for 10 minutes after the participant withdraws the hand from the bath. This testing will be performed at baseline and post-meal.
15974130|NCT03081390|Other|Flow-mediated dilation testing|At baseline and post-meal, we will assess flow-mediated dilation at the brachial artery using well-validated ultrasound techniques.
15974131|NCT03081364|Other|Initiate ACLS protocol if lethal arrythmia develops|Cardiac Rhythm Management
15974132|NCT03081351|Procedure|extended lymphadenectomy and nerve clearance|"The investigators will implement the pancreaticoduodenectomy using the principle of Total Peripancreas Excision to resect the lymph node and nerve plexus. The lymph node include standard 5,6,8a,12b1,12b2,12c,12a-b,14a-b,17a-b and extended 8p,9,12a,12p,14a-d,16a2,16b1 of the abdominal lymph node."
15974133|NCT03081351|Procedure|standard lymphadenectomy|The investigators will implement the pancreaticoduodenectomy using the standard lymphadenectomy. The lymph node include 5,6,8a,12b1,12b2,12c,12a-b,14a-b,17a-b of the abdominal lymph node.
15974134|NCT03081325|Procedure|low-dose lymphocyte immunotherapy|Peripheral venous blood (PBMCs) was drawn from the husbands of uRM and RIF patients and then the PBMCs were resuspended and administered intradermally to uRM and RIF patients 3 times at 3-week intervals. Once conceived, the uRM and RIF patients undergo 2 rounds of treatment at 8-week intervals.
15974135|NCT03081286|Procedure|Liposuction|Liposuction is performed on the abdomen or thighs as determined before randomization by the surgeon.
15974136|NCT03081286|Procedure|Fat graft|The harvested lipoaspirate is injected at the site of pain.
15974137|NCT03081286|Procedure|Sham graft (saline injection)|Saline will be injected at the site of pain instead of fat
15974138|NCT03081260|Other|Patellar resurfacing|The resurfacing of the patella is generally done at the end of the surgery, after having ejected the patella. A frontal bone cut is made using a dedicated ancillary to remove the entire cartilage. Orifices are then made in the patella so that the polyethylene implant can be accommodated with studs which will be cemented on the joint face of the ball joint.
15974139|NCT03081260|Other|Patellar non-resurfacing|Non-resurfacing of the patella does not involve any additional surgical action
15974140|NCT03081247|Drug|BGF 320/14.4/9.6 µg MDI|Budesonide, Glycopyrronium, and Formoterol Fumarate metered dose inhaler (BGF MDI)
15974213|NCT03080675|Dietary Supplement|Control|
15974142|NCT03081234|Drug|Ribociclib|Ribociclib 600 mg daily on days 1 to 21 of a 28-day cycle for 26 cycles (approximately 24 months). Ribociclib will be supplied in the form of 200 mg tablets.
15974143|NCT03081234|Drug|Placebo|Placebo 600 mg daily on days 1 to 21 of a 28-day cycle for 26 cycles (approximately 24 months). Placebo will be supplied in the form of 200 mg tablets.
15974144|NCT03081234|Drug|Adjuvant endocrine therapy|Tamoxifen 20 mg daily, or letrozole 2.5 mg daily, or anastrozole 1 mg daily, or exemestane 25 mg daily (male patients will be treated with tamoxifen 20 mg daily) for a total duration of at least 60 months. In premenopausal women, adjuvant endocrine therapy may include GnRH agonist administered every 28 days.
15974145|NCT03081221|Diagnostic Test|USG|
15974146|NCT03081208|Drug|Nolasiban 900mg|Nolasiban dispersible tablets for single oral administration
15974147|NCT03081208|Drug|Placebo|Placebo dispersible tablets for single oral administration
15974148|NCT03081195|Behavioral|MFG|The MFG is a series of weekly meetings guided by a protocol.Over the course of 16 weeks, groups are held weekly and are facilitated by trained and supervised group leaders (in this case either parent peers or community health outreach workers). Groups can consist of up to 20 families involving adult caregivers and all children over six years of age in the family. The protocols have been designed to provide opportunities during each session to directly apply content to the realities of family life, emergent cultural and values perspectives, as well as tailor messages to age of child. Redundancy for missed appointments and opportunities for reinforcement is built in. We aim for families to attend at least 8 meetings or more (out of 16 sessions in total), as findings suggests this dose is needed to reduce child conduct problems and the majority of families reach this goal.
15974149|NCT03081169|Drug|Enoxaparin Sodium 150 MG/ML Prefilled Syringe|The same drugs and dosages will be used in both groups, with only the timing being different
15974150|NCT03081169|Drug|Heparin|The same drugs and dosages will be used in both groups, with only the timing being different
15974151|NCT03081156|Drug|Glycopyrrolate / Formoterol|Exercise Tolerance
15974152|NCT03081143|Drug|FOLFIRI|Irinotecan 180 mg/m2; i.v. bolus of 5-FU 400 mg/m2, i.v. infusion of leucovorin* 400 mg/m2 , followed by a 46-hour continuous administration of 5-FU 2400 mg/m2 on day 1 and 15 of a 28-day cycle
15974153|NCT03081143|Drug|Ramucirumab|8 mg/kg i.v. infusion on day 1 and 15 of a 28-day cycle
15974154|NCT03081143|Drug|Paclitaxel|80 mg/m2 on day 1, 8, 15
15974155|NCT03081130|Procedure|Intravenous laser irradiation treatment|control group
15974156|NCT03081117|Drug|Insulin, intranasal|Regular insulin administered by specialized, non-commercial intranasal drug delivery device
15974157|NCT03081117|Drug|Placebo, intranasal|Saline solution administered by specialized, non-commercial intranasal drug delivery device
15974158|NCT03081104|Device|hystroscopy|The uterine cavity will be distended with saline or glycine, depending on the polarity of the resection system.with a maximum irrigation pressure of 110mmHg. The retained products will be resected from top to bottom with surgical resector without electric power. The use of forceps or curettes to facilitate the removal of material is permitted. If active bleeding occurs , elective coagulation by hystroscope is done to stop intrauterine bleeding. The deficit of distending media should be calculated at the end of procedure.
15974159|NCT03081104|Device|ultrasound|The transducer was held on the abdomen to obtain a longitudinal image of the uterus and cervix and provide the surgeon with a visual reference of the gestational sac, cervical canal and any instruments passed into the uterus.The progress of the operation was continuously monitored as the uterine contents were evacuated under visual control.
15974160|NCT03081104|Procedure|Aspiration|The cervical canal was dilated gradually with Hegar dilators up to the size corresponding to the weeks of gestation. The uterine cavity was evacuated using a plastic cannula attached to an electric suction apparatus. Negative pressure of 75 mmHg was used.
15974161|NCT03081091|Device|Acupuncture|"The needles used for the treatments will be single-use needles of two different gauge sizes. One size or the other will be used depending on the area to be treated and the physical condition of the patient. The needles and gauge sizes used in the study are as follows:
~Dong Bang siliconized needle 0.25 mm x 40 mm Dong Bang siliconized needle 0.20 mm x 30 mm
~The therapist will assess the patient's condition according to traditional Chinese medicine and will look at the relationship between the patient's most affected areas and the paths of the acupuncture meridians. Subsequently, the combination of Yuan and Luo points to be treated will be determined. This procedure will be followed before every acupuncture session, in such a way that the combination of the points used will depend on the evolution of the symptoms."
15974162|NCT03081091|Device|Sham Acupuncture|"It will follow the validated technique of sham acupuncture with the Park device, without needle penetration in the patient's body.
~The Park device for the performance of sham acupuncture consists of two plastic tubes, one sliding within the other, and inside which the needle created for the device slides. The longest tube is attached to a circular base, which has an adhesive surface that sticks to the skin so that the device and the needle cannot fall. Blunt ended needles will be used for this technique and thus the needle does not get to pass through the skin but produces a cutaneous stimulation similar to conventional acupuncture needles. These needles are supplied with the kit that contains the Park sham acupuncture device and are registered in the European Union as CE 0120."
15974163|NCT03081078|Behavioral|Volunteer support|Each participant will be matched with a pair of trained volunteers (under pre-determined safety measures), who will initiate caring contact via telephone or text messages at least twice a month for two months. Participants will be free to respond or not.
15974164|NCT03081078|Other|Mobile app|Participants will receive programmed care messages and reminders of community resources and healthcare contacts on a regular basis. The app will also provide simple self-help mood checking and relaxation exercises.
15974165|NCT03081065|Dietary Supplement|Mediterranean Diet|Nutritional advice to follow a Mediterranean diet and supplementation with extra virgin olive oil and nuts
15974166|NCT03081052|Drug|iNO|Subject will receive inhaled Nitric Oxide in this intervention
15974167|NCT03081052|Drug|iEPO|Subject will receive inhaled Epoprostrenol in this intervention
15974168|NCT03081039|Drug|Carboplatin|Arm A: Carboplatin or Cisplatin every 21 days for 6 cycles. Dose based on weight.
15974169|NCT03081039|Drug|Cisplatin|Arm A: Cisplatin or Carboplatin every 21 days for 6 cycles. Dose based on weight.
15974214|NCT03080662|Device|ORYGEN DUAL Sham Valve|Training of the inspiratory muscles during 5 weeks
15974170|NCT03081039|Drug|Gemcitabine|"Arm A: Given with either Cisplatin or Carboplatin every 21 days for 6 weeks. Dose based on individuals weight.
~Arm B: Gemcitabine alone every 21 days for 6 cycles. Dose based on weight."
15974171|NCT03081026|Diagnostic Test|Bilateral hip to ankle x-ray, exam and strength testing.|Only an X-Ray is performed and reviewed to identify any growth disturbances.
15974172|NCT03081013|Behavioral|Social information|Social comparison information will be provided to the study participants weekly via SMS
15974173|NCT03081013|Device|Fitbit|Fitbit is a wireless pedometer that tracks steps of participants and will be offered in conjunction with a tailored website with customised information for participants.
15974174|NCT03080987|Drug|JNJ-64179375 0.3 mg/kg|JNJ-64179375 0.3 milligram per kilogram (mg/kg) intravenous (IV) infusion on Day 1.
15974175|NCT03080987|Drug|JNJ-64179375 1.0 mg/kg|JNJ-64179375 1.0 mg/kg on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).
15974176|NCT03080987|Drug|JNJ-64179375 2.5 mg/kg|JNJ-64179375 2.5 mg/kg IV infusion on Day 1.
15974177|NCT03080987|Other|Placebo|Matching placebo on Day 1 administered as IV infusion (for Part 1) and SC injection (for Part 2).
15974178|NCT03080987|Drug|JNJ-64179375 (Dose to be Determined)|JNJ-64179375 IV infusion (Dose to be determined).
15974179|NCT03080974|Drug|Nivolumab|Given post-operatively every two weeks for a total of 4 doses. Dose based on weight.
15974180|NCT03080974|Procedure|Irreversible Electroporation|Non-thermal ablation of tumor
15974181|NCT03080961|Device|VIBLOK barrier cream|VIBLOK safety and performance has not been proven yet in humans with an HSV-2 infection.
15974182|NCT03080948|Behavioral|survey|Research assessments as part of this protocol will be scheduled during routine clinic visits
15974183|NCT03080948|Other|Saliva samples|Germline DNA analysis
15974184|NCT03080935|Drug|Evolocumab|Subjects will receive Evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM), according to the subject's preference.
15974185|NCT03080922|Biological|hematopoietic stem cell|high dose of donor G-CSF mobilized peripheral blood hematopoietic stem cell are infused to patient received normal chemotherapy
15974186|NCT03080909|Dietary Supplement|Encapsulated nutrients|Amino acid + Lipid; Probiotic bacteria; Lipid; Amino acid selected on their ability to stimulate release of GLP-1 and PYY
15974187|NCT03080909|Dietary Supplement|Placebo|Maltodextrin, which is not expected to stimulate release of GLP-1 and PYY
15974188|NCT03080896|Device|King Vision video-laryngoscope with #3 disposable blade and endotracheal tube stylet|intubation using King Vision video-laryngoscope with #3 disposable blade with stylet convert to intubation with video-laryngoscope and fiber-optic bronchoscope bronchoscope (aScope III) for failure to intubate after three attempts
15974189|NCT03080896|Device|fiberoptic bronchoscope aScope III|Intubation using the videolaryngoscope/fiberoptic bronchoscope (aScope III)
15974190|NCT03080883|Drug|Apixaban|Given PO
15974191|NCT03080870|Other|Art|Multicomponent art intervention
15974192|NCT03080857|Other|Virtual Platform|The platform will direct patients to review the Canadian Cardiovascular Guidelines and the Heart & Stroke website for commonly asked questions relating to atrial fibrillation, as well as recommendations regarding nutrition and activity.
15974193|NCT03080857|Device|AliveCor Heart Monitor|A substudy of patients enrolled into the CSAF Tool study who own a compatible smart phone will be randomized to the Alive Cor Heart Monitor plus the virtual platform versus the virtual platform alone. The purpose of this substudy is to assess the feasibility and effect of incorporating Alive COR into a virtual online patient-education platform on patients' quality of life and AF-related emergency room visits and hospitalizations.
15974194|NCT03080844|Behavioral|Delay time to first cigarette|Participants asked to delay time until they smoke first cigarette of the day.
15974195|NCT03080844|Behavioral|Therapy|Participants receive tips on how to resist the urge to smoke and control cravings to smoke.
15974196|NCT03080831|Drug|NaCl 0.9% in Glucose 5% + 40mmol/L Potassium|Study fluid used at maintenance rate of 27 mmol per kg of body weight per day from beginning of surgery until end of study.
15974197|NCT03080831|Drug|Glucion 5%|Study fluid used at maintenance rate of 27 mmol per kg of body weight per day from beginning of surgery until end of study.
15974198|NCT03080818|Dietary Supplement|Probiotic - Lactobacillus Rhamnosus GG|2 capsules per day for 90 days
15974199|NCT03080818|Other|Placebo|2 placebo capsules per day for 90 days
15974200|NCT03080805|Drug|Pyrotinib Plus Capecitabine|pyrotinib(400 mg once daily) + capecitabine (2000 mg/m^2 daily, 1000 mg/ m^2 BID)
15974201|NCT03080805|Drug|Lapatinib Plus Capecitabine|Lapatinib (1250 mg once daily)+ capecitabine (2000 mg/m^2 daily, 1000 mg/m^2 BID)
15974202|NCT03080792|Behavioral|Experimental: moderate to high-intensity exercise|2x per week endurance exercise (continuous moderate and high intensity intervall training on a cycle ergometer) and progressive resistance training (machine based hypertrophy training)
15974203|NCT03080766|Drug|Decitabine|Decitabine (trade name Dacogen®) is a cytidine deoxynucleoside analogue, which selectively inhibits DNA methyltransferases at low doses, resulting in gene promoter hypomethylation that can result in reactivation of tumor suppressor genes, induction of cellular differentiation or cellular senescence followed by programmed cell death.
15974204|NCT03080753|Device|Sphinkeeper|Intersphincteric implants in the anal sphincter
15974205|NCT03080740|Drug|Clindamycin palmitate hydrochloride dispersible tablet|300mg, oral after meal, twice daily, a total of 7days
15974206|NCT03080740|Drug|Metronidazole Tablet|400mg, oral after meal , twice daily, a total of 7days
15974207|NCT03080714|Device|Topcon DRI OCT Triton (plus)|The Topcon DRI OCT Triton (plus) is an OCT machine used for diagnostic purposes
15974208|NCT03080714|Device|3D OCT-1 Maestro|The 3D OCT-1 Maestro is an OCT machine used for diagnostic purposes
15974209|NCT03080701|Behavioral|Auto Mailing Plus Money|Participant receives money as a thank you for completing CRC screening within 6 months.
15974210|NCT03080701|Behavioral|Auto Mailing Plus Lottery|Participant has a 1 in 10 chance of winning money in a lottery for completing CRC screening within 6 months.
15974211|NCT03080688|Device|Prizma Oxygen Saturation Measurement|"A radial arterial cannula was placed in either the left or right wrist of each subject.
~Blood gas analysis to determine oxyhemoglobin saturation was performed on an OSM-3® multi-wavelength oximeter (Hemoximeter, Radiometer, Copenhagen). No subject was anemic (Hemoglobin ≤ 10gm•dl-1)."
15974259|NCT03080298|Drug|Placebo|
15974215|NCT03080662|Device|ORYGEN DUAL Valve|Training of the inspiratory muscles during 5 weeks
15974216|NCT03080649|Device|excavated with rotary bur|One of two identified caries lesions in the patient were randomly allocated to be excavated with rotary bur
15974217|NCT03080649|Device|Er:YAG laser|One of two identified caries lesions in the patient were randomly allocated to be excavated with Er:YAG laser
15974218|NCT03080636|Other|Aerobic exercise|30 minutes of treadmill exercise at 60-70% of heart rate reserve
15974219|NCT03080636|Other|Resistance exercise|30 minutes of circuit resistance session at 40% of 1 maximun repetition test
15974220|NCT03080636|Other|Control session|30 minutes seated resting
15974221|NCT03080597|Device|PrEP Smart app|"English-speaking males, between the ages of 18-30, who are enrolled at a HBCU or identify as Black/African American, who are currently prescribed PrEP (Truvada) for HIV Prevention, and owners of either an Android or iOS smartphone, will be asked to use an application on their smart phones called PrEP Smart.an application on their smart phones called PrEP Smart."
15974222|NCT03080584|Other|acupuncture|12 weeks of acupuncture comprising basic acupuncture, ear acupuncture and Moving cups. On top of the basic acupuncture, additional locations can be added.
15974223|NCT03080571|Biological|autologous BMMNC stem cells|Autologous BMMNC injected in the ipsilateral MCA
15974224|NCT03080571|Other|standard care|
15974225|NCT03080558|Drug|Indocyanine green|Use of Indocyanine Green during Rectal shaving by laparoscopy.
15974226|NCT03080545|Drug|Enstilar 0.005%-0.064% Topical Foam|Topical foam
15974227|NCT03080532|Other|dietary habits|
15974228|NCT03080519|Procedure|Endovascular Therapy|Balloon angioplasty and stenting for renal artery stenosis
15974229|NCT03080506|Device|Elastic abdominal binder|Participants will be fitted with an elastic abdominal binder at the time of procedure completion just before leaving the operating room. The binder will be placed snuggly tight on top of the hospital gown at the infraumbilical level with the incision positioned at the middle part of the binder. The patients will be encouraged to wear binders at all time. However, periods of break from wearing the binder will be allowed at their convenience.
15974230|NCT03080493|Drug|Gabapentin 600mg|Gabapentin 600 mg PO (two total doses, thereby lasting duration while osmotic dilators are in place)
15974231|NCT03080493|Drug|Placebo oral capsule|Packaged identical to gabapentin dosing
15974232|NCT03080493|Drug|acetaminophen/codeine and ibuprofen|Over the counter analgesic medications
15974233|NCT03080480|Drug|Pioglitazone|"Pioglitazone is PPARγ agonist that may be enhance ROS production and partially restore host phagocytes in CGD.
~pioglitazone is administered at a starting dose of 1 mg/kg and given the absence of adverse effects is progressively increased up to 3 mg/kg or 30 mg/daily."
15974234|NCT03080454|Device|sham Doublestim|PathMaker MyoRegulator device
15974235|NCT03080454|Device|anodal Doublestim|PathMaker MyoRegulator device
15974236|NCT03080441|Device|pressure stockings|pressure stockings worn during dialysis throughout treatment period
15974237|NCT03080441|Drug|Midodrine|administered Midodrine before each dialysis treatment during treatment period based on PI's judgement. Including consideration of blood pressure.
15974238|NCT03080441|Other|pressure stockings and midodrine|combination of Midodrine and pressure stocking before each dialysis treatment throughout treatment period
15974239|NCT03080428|Diagnostic Test|Genomic test|genomic test realized on surgery block or formalin-fixed paraffin-embedded slides
15974240|NCT03080415|Drug|Combined Therapy SOF and DCV|"1 whole or half tablet sofosbuvir and 1 whole or half tablet daclatasvir per day
~SOF dosage: 400 mg/day for greater than 45 kg weight patients; 200 mg/day for 17 kg to 45 kg patients
~DCV dosage: 60 mg/day for greater than 45 kg weight patients; 30 mg for 17 kg to 45 kg patients"
15974241|NCT03080402|Device|Mechanical Perturbation Training|The training program will consist of three stages and subjects will progress through each neuromuscular training stage.The training will consist of double- to single-limb movements with progression of jumping, hopping, and pivoting maneuvers on the perturbation device with an emphasis on proper technique and landing. The initial four sessions will focus on primarily on jumping and hopping maneuvers on double- and single-limb in the sagittal plane. The intermediate four sessions will incorporate additional medial and lateral maneuvers with the plyometric tasks. The final four sessions will incorporate rotational and pivoting activities with the maneuvers. The resultant protocol has been derived and optimized from previous published research studies and prevention techniques.
15974242|NCT03080389|Procedure|Extended Urine Culture|"Extended Urine Culture Standard cultures will include 0.001 ml of specimen plated on sheep blood agar and MacConkey agar. Plates were inoculated and incubated at 35 degrees Celsius for 24 hours. Samples were considered positive if there were 10^3 cfu or greater. The extended urine culture will be spun down by centrifuge (3000 rpm for 5 min) and 0.1 ml of the sediment will be cultured for 48 hours.
~The participants will fill out the Bother, UDI-6, and PUF questionnaires before the cultures. If a patient has a positive urine culture, the patient will be asked to repeat the questionnaires 7-30 days post treatment with antibiotics. A comparison will be made between the standard and extended urine cultures to assess for a difference in identification and treatment of uropathogens."
15974243|NCT03080376|Other|Web-based intervention with support|Web-based combined aerobics and muscular strength exercises.
15974244|NCT03080376|Other|Web-based intervention without support|Web-based combined aerobics and muscular strength exercises.
15974245|NCT03080376|Other|Traditional intervention|3 months of Printed-based combined aerobics and muscular strength exercise intervention.
15974246|NCT03080363|Drug|Bupivacaine|10 ml %0.5 bupivacaine
15974247|NCT03080363|Drug|Lidocaine|10 ml %2 lidocaine
15974248|NCT03080350|Drug|Fentanyl sublingual|Fentanyl sublingual
15974249|NCT03080350|Drug|Fentanyl ev|Fentanyl ev
15974250|NCT03080350|Drug|Placebo sublingual|Placebo sublingual
15974251|NCT03080350|Drug|Placebo ev|Placebo - NaCL 0,9% ev
15974252|NCT03080337|Other|Group Care|Participation in 12 group sessions with 6-10 women who are also pregnant and have diabetes.
15974253|NCT03080324|Drug|Fentanyl sublingual|Fentanyl sublingual
15974254|NCT03080324|Drug|Fentanyl ev|Fentanyl ev
15974255|NCT03080324|Drug|Placebo sublingual|Placebo sublingual
15974256|NCT03080324|Drug|Placebo ev|Saline
15974257|NCT03080311|Drug|APG-1252|Multiple dose cohorts, 30 minute IV infusion, twice weekly for 3 weeks of a cycle with 28 days.
15974258|NCT03080298|Drug|BP101|
15974260|NCT03080285|Device|over-glasses patch|Over-glasses patch (Tomato Eye Patch, Tomato Inc., Busan, South Korea) is applied to the patients. They were prescribed 2 hours of patching per day for the sound eye.
15974261|NCT03080285|Device|Conventional patch|Conventional patch (Opticlude Eye Patch, 3M, Maplewood, MN, USA) is applied to the patients. They were prescribed 2 hours of patching per day for the sound eye.
15974262|NCT03080272|Other|no intervention will take place|Only registration and data collection of patients' care and treatment will take place. There will be no changes in patients' treatment. No intervention will take place
15974263|NCT03080259|Behavioral|Stimulant Diversion Prevention (SDP)|provider training, patient/parent education and counseling, strategies for use by patients and parents, and treatment adjustments
15974264|NCT03080246|Behavioral|Strength Training Exercise|
15974265|NCT03080220|Device|Astym|therapeutic massage instrument
15974266|NCT03080220|Device|Stick|massage instrument
15974267|NCT03080220|Device|Massage|massage instruments
15974268|NCT03080207|Procedure|PRP method|It will first be placed on a 25 cc venous blood centrifuge in anticoagulated tubes containing acid citrate dextrose (ACD), and autologous venous blood will be centrifuged at 3200 rpm for 15 minutes. Using the PRP kit, the plasma rich in platelet volume of about 3 cc volume will be removed. This will be activated by the addition of platelet agonists such as thrombin, calcium gluconate or calcium chloride. Injections should be administered subcutaneously for 2-3 weeks, 3-4 times for inguinal, popliteal region and ankle for a total of 12 weeks. Also, all patients in this groups have received Complex Decongestive Physiotherapy (Manual lymph drainage (MLD), skin care, compression therapy and active therapeutic exercise).
15974269|NCT03080207|Procedure|Low Level Laser|"Low Density Laser treatment will be applied for the first 4 weeks every 12 weeks, the remaining 8 weeks 2 days / week. A total of 9 regions (6 point inguinal region and 3 points popliteal region) are to be applied by applying the laser head close to the skin (20000 Hz, 1.5 J / cm2) with the laser device and the regions where lymph nodes and lymph pathways are dense.
~During the application, the patient will be in the supine position for the popliteal region, with the patient in the supine position for the inguinal region and the legs free in the abdomen.Also, all patients in this groups have received Complex Decongestive Physiotherapy (Manual lymph drainage (MLD), skin care, compression therapy and active therapeutic exercise)."
15974270|NCT03080207|Procedure|Complex Decongestive Physiotherapy|Complex Decongestive Physiotherapy (CDP) consists of four basic components and two phases. Four basic components; Manual lymph drainage (MLD), skin care, compression therapy and therapeutic exercise. Phase I (intense phase): It is also referred to as the phase of reducing the remission. In this phase, skin care and compression bandages are renewed after daily MLD application. The patient is taught how to bandage on his own. (Phase I, 4 weeks) The duration of phase I may vary according to the patient. In Phase II, MLD can be administered 2 or 3 times per week depending on the needs of the individual. In this case, the patient is followed by home program. Our cases will be treated in Phase I every day for 12 weeks in total and 2 days / week in Phase II according to KBF phases. All patients in this group have received only Complex Decongestive Physiotherapy.
15974271|NCT03080194|Drug|paliperidone palmitate|Subjects in experimental group will be injected with 150mg eq and 100mg eq paliperidone palmitate in the deltoid at the 1st and 8th day, and afterwards a flexible dose of paliperidone palmitate from 75 to 150mg eq will be administrated monthly according to clinical judgement. Previous oral antipsychotics could be continued or withdrawn in 2-4 weeks after first paliperidone palmitate administration according to doctors' clinical judgement.
15974272|NCT03080194|Drug|control group|Subject in control group will be applied with oral antipsychotics or other conventional medication.
15974273|NCT03080181|Drug|Pasireotide 0.6 MG/ML|The aim of the study was to evaluate the effect of pasireotide on β -cell and adipose function in patients with Cushing's disease (CD).
15974274|NCT03080168|Device|Actigraph|This is NOT an intervention but a monitoring device. All participants will wear an Actigraph for the duration of their inpatient stay, as well as complete paper and computer assessments.
15974275|NCT03080155|Device|MIRA device imaging|MIRA Device imaging for adjunctive detection of breast cancer
15974276|NCT03080142|Drug|Exparel|Patients will receive an injection of 30ml of volume to each abdominal side with a total of 60 ml for bilateral TAP blocks.
15974277|NCT03080142|Drug|Ropivacaine|Patients will receive 30ml of ropivicaine. Peripheral nerve catheters will be placed approximately 3-5cm into the TAP space and secured to the skin with tegaderm tape. Infusions will be ordered with CADD pumps and will be initiated at a rate of 8ml/hr of 0.2% ropivicaine on the inpatient floor.
15974278|NCT03080129|Dietary Supplement|Fresubin energy|dietary protein energy supplement
15974279|NCT03080116|Drug|ARN-509|240mg/day (4x60mg tablets, Oral administration: OS)
15974280|NCT03080116|Drug|Degarelix|1st injection: 120mg Subcutaneous administration (SC) x2, 2nd-3rd SC injection 80mg monthly
15974281|NCT03080116|Other|Placebo|4 tablets, per OS
15974282|NCT03080103|Procedure|Laparoscopic or Open appendectomy|Laparoscopic three-port or single-port appendectomy; or conventional McBurney laparotomic appendectomy; or open appendectomy performed through midline incision
15974283|NCT03080103|Drug|Antibiotic-first therapy|Patients treated with antibiotics as first-line approach
15974284|NCT03080090|Behavioral|Aerobic exercise|Individuals will work with a YMCA personal trainer to engage in aerobic exercise 3 times a week (25 mins each) for 15 weeks.
15974285|NCT03080090|Behavioral|Smoking Cessation Intervention|Individuals will work with a national quitline to help them with their smoking cessation goals and make a quit attempt at week 5 of the program.
15974286|NCT03080077|Drug|Ricrolin+|The IONTOPHOR CXL iontophoresis applicator and the associated blepharostat will be placed onto the cornea to be treated. The applicator will be secured to the cornea and filled with Ricrolin+ which as been aspirated from the bottle using a syringe with a needle. The generator will be switched on and set to 1 mA for 5 minutes. The generator will then be disconnected and the applicator will be removed from the cornea.
15974321|NCT03079778|Procedure|transarterial chemoembolization|Transcatheter arterial chemoembolization (also called transarterial chemoembolization or TACE) is a minimally invasive procedure performed in interventional radiology to restrict a tumor's blood supply
15974322|NCT03079778|Radiation|TACE plus RT|radiobiologically guided radiation
15974624|NCT03077711|Drug|Trimethoprim|suppressive antibiotic. Estrogen cream may be prescribed if the patient is post-menopausal (but not as a part of this study).
15974287|NCT03080077|Drug|Epi-Off|Using topical anesthesia (proparacaine), the surgeon will create a complete corneal abrasion to facilitate riboflavin diffusion into the cornea. The epithelium will be removed by gently brushing the cornea with a scalpel. A corneal abrasion diameter of ~9mm is recommended, which may be adjusted as needed at the discretion of the investigator to accommodate individual eye geometry. Ultrasound corneal pachymetry should be performed before dis-epithelialization and after dis- epithelialization. Local anesthetics will be administered as needed to maintain patient comfort during the CXL procedure.
15974288|NCT03080064|Behavioral|Health Coach Intervention|Please see arm description.
15974289|NCT03080051|Drug|[18F]MNI-952|Subjects will undergo PET imaging using [18F]MNI-952, a PET radioligand for imaging tau.
15974290|NCT03080051|Drug|[18F]Florbetapir|Subjects with Alzheimer's disease will receive a [18F]florbetapir scan to compare distribution of tau in the brain compared to that of [18F]MNI-952.
15974291|NCT03080038|Other|Fluid Sparing Resuscitation Strategy|"Tier 1: Initiate IV/IO vasoactive medication infusion support immediately. Further IV/IO isotonic fluid bolus therapy [crystalloid (0.9% Normal Saline or Ringers Lactate) or colloid (5% Albumin)] should be avoided; small volume isotonic fluid boluses [5-10 mL/kg (250-500 mL for participants ≥ 50 kg)] may be provided if required due to A. Clinically unacceptable delay in ability to initiate vasoactive medication infusion(s) and/or 2. Documented intravascular hypovolemia.
~Tier 2: Vasoactive medication(s) should be preferentially titrated/escalated to achieve recommended ACCM hemodynamic goals. Further IV/IO isotonic fluid bolus therapy [crystalloid (0.9% Normal Saline or Ringers Lactate) or colloid (5% Albumin)] should be avoided; small volume isotonic fluid boluses [5-10 mL/kg (250-500 mL for participants ≥ 50 kg)] may be provided if required due to A. Documented intravascular hypovolemia.
~Intervention end: Patient is free from vasoactive medication support and shock is reversed."
15974292|NCT03080025|Behavioral|CBCT® (Cognitively Based Compassion-Training)|"The CBCT® (Cognitively Based Compassion-Training) as a secular approach was established as a structured protocol.
~The therapeutic tools are based on systemic approaches & techniques, which contains a resource- & solution orientation and the approach of Gottman's model of healthy relationships (e.g. trust and commitment - based on that - elements like the positive perspective).
~Four dyadic exercises are introduced to enhance positive reciprocity between the romantic partners (based on concepts of couple communication training):
~a) Building mindful ability to talk, b) building mindful ability to listen (without reacting initially), c) appreciation in action - indulging the partner, d) noticing, how the partner is doing something good for me - gratefulness in action verbally/non-verbally. Finally, the empathy exercise has been added inspired by CBASP therapy for chronic major depression."
15974293|NCT03080012|Other|Saliva sampling|Stimulated saliva samples are taken using cotton rolls.
15974294|NCT03080012|Other|Plasma/serum sampling|Simultaneously with saliva sampling.
15974297|NCT03079986|Other|Standard care irrespective of CL|Removal of surgical drains despite persistent CL, without dietary restrictions or dietary treatment for CL.
15974298|NCT03079986|Other|Dietary treatment (MCT-diet)|Dietary treatment with MCT-diet until resolution of CL.
15974299|NCT03079973|Drug|P-3073 (calcipotriene 0.005%)|Topical solution P-3073 (calcipotriene 0.005%) once daily for 24 weeks.
15974300|NCT03079973|Drug|Vehicle of P-3073|Once daily for 24 weeks.
15974301|NCT03079960|Device|Electrophysiological recording and measurement devices|Externalization of DBS connectors and macroelectrodes for simultaneous STN stimulation LFP recordings by the use of electrophysiological recording and measurement devices.
15974302|NCT03079934|Device|Absorb-BVS|BVS patients undergoing optical coherence tomography examination at follow-up
15974303|NCT03079921|Drug|Phentolamine|Physiologic receptor blockade (α1-receptor).
15974304|NCT03079921|Drug|Propranolol|Physiologic receptor blockade (β2-receptor).
15974305|NCT03079921|Drug|Placebo|100mL bag of Normal Saline Solution (NSS).
15974306|NCT03079908|Other|da Vinci Skills Simulator®|Initial robotic virtual reality surgical simulator Training (da Vinci Skills Simulator ® System), then laparoscopic dry box evaluation
15974307|NCT03079908|Other|LapSim®|Initial laparoscopic virtual reality surgical simulator training (LapSim ® System), then laparoscopic dry box evaluation
15974308|NCT03079908|Other|Dry lab box laparoscopic training|No initial simulator training. Dry lab box laparoscopic Training only.
15974309|NCT03079895|Behavioral|Thrive|Thrive is an online self-help tool designed to assess for depressive symptoms and give therapeutic suggestions based on Cognitive Behavioral Therapy principals.
15974310|NCT03079869|Drug|Ferric Citrate|One to two tablets of Ferric Citrate phosphorus binder administered by mouth before every meal to prevent dietary phosphorus absorption.
15974311|NCT03079856|Behavioral|Brief Intervention|"Intervention for emerging adults (EAs) seeking care in the ED. The intervention will be rooted in motivational interviewing (MI) and will be guided by social cognitive, self-determination, and the trans-theoretical theories. The ED visit presents a teachable moment for intervening to promote health behavior, therefore eligible EAs will receive a ~30 minute MI-based session in the ED. In order to capitalize on and potentially extend this moment, participants will receive daily booster notifications delivered through a secure mobile app that they will download to their phone at enrollment."
15974312|NCT03079843|Other|exposure to particulate matter with N 95 facemask|2 hours' / day exposure to particulate matter face mask worn during exposure.
15974313|NCT03079843|Other|exposure to particulate matter with no face mask|2 hours'/ day exposure to particulate matter with no face mask
15974314|NCT03079830|Drug|Piritramid|Piritramid will be administered i.v., if the patients feel pain after receiving a bolus of Ropivacaine or saline through the catheter.
15974315|NCT03079830|Drug|Saline|Piritramid will be administered i.v., if the patients feel pain after receiving a bolus of Ropivacaine or saline through the catheter.
15974316|NCT03079817|Other|Yoga Meditation|Yoga meditation using motor imagery to perceive movement patterns
15974317|NCT03079817|Other|Proprioceptive Drills|Active balance and proprioception drills
15974318|NCT03079804|Other|Experimental MWM|Mobilization with Movement
15974319|NCT03079804|Other|Experimental Thrust|Mobilization grade 5 (Thrust)
15974320|NCT03079804|Other|Placebo|Procedures similar to Experimental MWM group, but without aplly any force
15974448|NCT03078868|Device|Magnetic Resonance Scanner|MRI
15974323|NCT03079765|Behavioral|Behavioral skills training|Participants will receive feedback and error correction on their implementation of the assessment procedures. Feedback will take the form of the experimenter pointing out components of the assessment that are not being conducted accurately and error correction will take the form of the experimenter reviewing the correct way to implement that component of the assessment.
15974324|NCT03079765|Behavioral|Protocol Only|Participants will be given a written protocol describing how to conduct the target assessment procedure.
15974325|NCT03079752|Behavioral|Developmental Screening|Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment of suspected problems at 12 and 24 months of age
15974326|NCT03079752|Behavioral|Screening plus Transportation|Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment for suspected problems at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2.
15974327|NCT03079752|Behavioral|Screening, Transport, Prenatal Visits|Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment for suspected problems at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2, and were provided an average of 9 home visits by nurses during pregnancy.
15974328|NCT03079752|Behavioral|Screen, Transport, Prenatal/Inf Visits|Child participants were screened for sensory and developmental problems and referred for further evaluation and treatment for suspected problems at 12 and 24 months of age; their mothers were provided with free transportation for prenatal and well-child care through child age 2, and were provided an average of 9 home visits by nurses during pregnancy and 23 during the child's first two years of life.
15974329|NCT03079739|Diagnostic Test|fractional flow reserve|assessment with FFR in at least one coronary lesion
15974330|NCT03079713|Device|Handheld vibrator triggered during intravitreal injection for wet ARMD|A vibratory device cleaned with alcohol swabs between each use will be attached to the injectors' finger, placed on the lower eyelid of the treatment eye, and triggered during intravitreal injection
15974331|NCT03079713|Device|Normal eye esthesiometry with and without vibration|Healthy patients will undergo corneal and conjunctival esthesiometry with and without triggering of the wearable vibrator placed upon the lower lid of a single eye.
15974332|NCT03079713|Device|Handheld vibrator not triggered during intravitreal injection for wet ARMD|Control group undergoing standard intravitreal injection without triggering of the vibrator.
15974333|NCT03079700|Biological|Trichuris suis eggs|Live eggs from swine whipworm, Trichuris suis
15974334|NCT03079687|Drug|Olaparib tablets|Patients will receive olaparib tablets 300mg (two 150mg tablets) twice daily.
15974335|NCT03079674|Other|observational only- no intervention|observational only- no intervention
15974336|NCT03079648|Dietary Supplement|Angelica gigas N. extract|capsules (2cap/d, 1,000mg/d) for 12 weeks.
15974337|NCT03079648|Dietary Supplement|Placebo|Placebo for 12 weeks
15974338|NCT03079635|Dietary Supplement|Control|Beverage provided and a four hour postprandial assessment of energy metabolism using a metabolic cart and appetite using a visual analog scale follows.
15974339|NCT03079635|Dietary Supplement|Omega 3 fatty acids|Beverage provided and a four hour postprandial assessment of energy metabolism using a metabolic cart and appetite using a visual analog scale follows.
15974340|NCT03079622|Procedure|Electric Vacuum Aspiration|
15974341|NCT03079622|Procedure|Manual Vacuum Aspiration|
15974342|NCT03079609|Procedure|subinguinal microscopic varicocelectomy|During the procedure approximately 1cm long fragment of varicose vein will be taken for further investigation.
15974343|NCT03079609|Procedure|open hernia repair|During the procedure approximately 1cm long fragment of spermatic cord vein will be taken for further investigation.
15974344|NCT03079596|Procedure|ERAS perioperative cares|Patient's preoperative counseling & education before surgery No Bowel preparation Oral Carbohydrate Solution (OCS) loading until 2hours before surgery Fluid restriction & Management by pulse contour analysis or transesophageal doppler Early mobilization Early oral feeding (postoperative 1 day - sips of water, 2 days - semifluid diet (SFD), 3 days - soft blended diet (SBD)) Epidural patient controlled analgesics (no opioids analgesics) Postoperative Nausea Active Control Thromboembolism prophylaxis by low molecular weighted heparin (LMWH) Perioperative High content Oxygen therapy No drain insertion No Levin tube Patients will be discharged at POD#4 if there's no problem.
15974345|NCT03079596|Procedure|Conventional perioperative cares|No Patient's preoperative counseling & education before surgery Bowel preparation No Oral Carbohydrate Solution (OCS) loading until 2hours before surgery Conventional Fluid Management by clinical signs (Urine output, heart rate etc.) Conventional Mobilization Conventional oral feeding (POD#2 SOW, #3 SFD, #4 SBD) IV PCA Postoperative Nausea Control if needed No Thromboembolism prophylaxis No or Low Content Oxygen therapy Routine drain insertion Levin tube insertion if needed
15974346|NCT03079583|Dietary Supplement|Intervention-group|Biofortified Rice is grown by foliar Zn application
15974347|NCT03079583|Dietary Supplement|Control-group|Control Rice with normal zinc levels
15974348|NCT03079557|Drug|Intragastric botulinum toxin type A|200 units Botulinum toxin A (Allergan) injected intragastrically in the antrum every six months
15974349|NCT03079544|Combination Product|L-Asparaginase or or Pegaspargase containing chemotherapy|Patients receive at least one cycle of combinational chemotherapy containing L-asparaginas or Pegaspargase.
15974350|NCT03079531|Drug|Secukinumab|Secukinumab 300 mg administered subcutaneously.
15974351|NCT03079518|Drug|Ferric Carboxymaltose|single shot infusion
15974352|NCT03079518|Other|blood withdrawal|for determination of serum and urinary biomarkers of chronic kidney disease metabolism and other parameters
15974353|NCT03079505|Drug|Dasatinib 100 MG [Sprycel]|Dasatinib (Sprycel) 100 milligram, once-daily (QD) will be given to 25 patients orally
15974354|NCT03079505|Drug|Nilotinib 150mg oral capsule [Tasigna]|Nilotinib (Tasigna) 300 milligram, twice-daily (BID) will be given to 25 patients orally
15974355|NCT03079492|Device|Magnetic resonance imaging|Magnetic resonance imaging will be used to estimate brain temperature and cerebral blood flow
15974356|NCT03079479|Diagnostic Test|Muscle Strenght assesment|Muscle Strenght assesment of the hip muscles
15974357|NCT03079479|Diagnostic Test|2D Kinematics Analysis|2D Kinematics Analysis of the gait
15974449|NCT03078855|Dietary Supplement|Vitamin D|vitamin D3 2,000 IU daily
15974358|NCT03079466|Other|CPAP|This is a randomized study where patients are included consecutively under a randomization order that will be given to the investigators. Patients will continue to be treated with CPAP and other treatment with no CPAP for a duration of 3 months and with intention-to-treat analysis And by protocol.
15974359|NCT03079453|Drug|Dexamethasone|The patients in Group 1 were injected with dexamethasone (1 ml, 8 mg) through the uvula and soft palate tissue directly before tonsillectomy
15974360|NCT03079440|Drug|TEMCAP|Oral capecitabine 750 mg/m2 twice a day, Day 1 to 14 and oral temozolomide 200 mg/m2 once a day, Day 10 to 14
15974361|NCT03079427|Drug|Gemcitabine plus cisplatin|Gemcitabine 1,000 mg/m2 and cisplatin 25 mg/m2 Day 1 and 8, every 3 weeks
15974362|NCT03079427|Drug|Capecitabine|Capecitabine 1,250 mg/m2 Day 1 to 14, every 3 weeks
15974363|NCT03079414|Procedure|Invasive Electrophysiology Study|Invasive electrophysiology studies will be performed using four catheters placed in the right ventricular apex, the coronary sinus, the His bundle region, and the high right atrium. Standard induction protocols for supraventricular and ventricular arrhythmias will be utilized in the absence and presence of isoproterenol. Long-short ventricular extra-stimuli will also be delivered to screen for bundle branch reentrant ventricular tachycardia. The study is considered observational as the participating sites perform electrophysiology studies in this patient population as part of standard clinical care.
15974364|NCT03079401|Biological|MPC; rexlemestrocel-L|MPCs will be injected into the patient's myocardium during planned surgical procedures.
15974365|NCT03079388|Dietary Supplement|Ready-to-use-supplementary food|Specially formulated supplementary food for pregnancy
15974366|NCT03079388|Dietary Supplement|Corn-soy-blend|Standard of care for malnutrition in pregnancy in Sierra Leone
15974367|NCT03079388|Drug|Monthly intermittent preventive treatment of malaria during pregnancy (IPTp)|Sulfadoxine-pyrimethamine (500 mg / 25 mg) given every 4 weeks, beginning at enrollment or at 13 weeks' gestation, whichever is later.
15974368|NCT03079388|Drug|Standard intermittent preventive treatment of malaria during pregnancy (IPTp)|Standard of care for Sierra Leone is 2 doses of sulfadoxine/ pyrimethamine (500mg/ 25mg).
15974369|NCT03079388|Other|Insecticide-treated mosquito net|An insecticide-treated mosquito net at the time of enrollment into the study.
15974370|NCT03079388|Drug|Azithromycin|Azithromycin 1 gram given once in second trimester and again during weeks 28-34 of gestation.
15974371|NCT03079388|Drug|Albendazole|Single dose albendazole 400mg given in the second trimester.
15974372|NCT03079388|Combination Product|Bacterial vaginosis testing and treatment|Testing for bacterial vaginosis at enrollment and again at weeks 28-34 using a rapid diagnostic test for sialidase. Those with positive tests will receive extended release metronidazole 750mg daily for 7 days.
15974373|NCT03079375|Other|basic intervention|medication review
15974374|NCT03079375|Other|extended intervention|medication review, medication interview before discharge and follow-up
15974375|NCT03079349|Other|Medical Education|All candidates in the Active Comparator: Traditional Classroom will take a pre course test of the subject material followed by two 9-hour and one 8-hour educational sessions given over 3 consecutive days. Following the educational sessions all candidates in the Active Comparator: Traditional Classroom will take a post course test.
15974376|NCT03079349|Other|Medical Intervention|All candidates in the Experimental: Online Synchronous Classroom will take a pre course test of the subject material followed by two 9-hour and one 8-hour educational sessions given over 3 consecutive days. Following the educational sessions all candidates in theExperimental: Online Synchronous Classroom will take a post course test.
15974377|NCT03079336|Behavioral|Implementation - SOTA|The implementation of an evidence-based treatment is largely principle-based - allowing considerable therapeutic flexibility in determining and timing of different treatment aspects. In this condition progress, subtle changes and sudden gains may be an explicit topic and there is no restraint to avoid such topics. However, the therapists are not obligated to take a systematized focus on potential subtle changes and they may use the timing of the sessions to involve the patients into the other tasks of therapy.
15974378|NCT03079336|Behavioral|Implementation - Prolonged focus on changes|Systematized sequence of exploration of subtle changes at a prolonged check-in phase: (1) the precise change situation, (2) related emotional states, (3) related helpful thoughts and self-verbalizations, (4) reinforcement of generalized self-efficacy and treatment motivation, (5) benefit for the upcoming session goals (Flückiger, Grosse Holtforth, et al. 2013, 2014).
15974379|NCT03079336|Behavioral|Mastery your Anxiety and Worry (MAW)|"In the present study, the MAW-packet will be applied within a usual 16-session individual therapy format and up to 3 further booster sessions.
~The session format of 50-60 minute usually consists of (a) a check-in phase of 5 to 15 minutes that includes a patients welcoming, reviewing self-help and agenda setting, (b) a working phase around 35-45 minutes that focuses on the previously agreed session goals, (c) a feedback phase of 5 to 10 minutes that summarizes the session and previews the upcoming self-help assignment."
15974380|NCT03079323|Radiation|PART-trial|Elective radiation to the para-aortic lymph nodes 45 Gy / 1.8 Gy
15974381|NCT03079310|Device|Spinal cord stimulation|Range of pulse widths (200-500 microseconds) and frequencies (30-130 Hz) will be assessed for each patient
15974382|NCT03079297|Drug|L-Leucine|L-leucine is an essential amino acid which will be provided as an effervescent powder mixture to participants.
15974383|NCT03079297|Other|Maltodextrin|Maltodextrin is a nonsweet carbohydrate which will be provided as an effervescent powder mixture similar in taste and appearance to the L-leucine containing effervescent powder mixture
15974384|NCT03079284|Other|Holding during cooling|An initial set of vital sings will be recorded before the infant is removed from the isolette. The mother will sit in a reclining chair next to the isolette and place a thermal barrier over her chest and abdomen. The infant will be transferred to the mother by placing the hands under the cooling blanket so as to move the infant and cooling blanket together as one unit. The mother will be allowed to hold for thirty minutes provided that the infant's temperature does not increase by greater than one degree centigrade and the oxygen saturation does not drop below 90%. After thirty minutes, the infant will be returned to the isolette.
15974385|NCT03079271|Drug|Lacrisert, 5 Mg Ophthalmic Insert|
15974386|NCT03079258|Other|Exercise|Previously inactive pregnant women will be asked to complete 3-4 sessions of aerobic exercise each week for 24 weeks of 15-30 minutes in duration.
15974450|NCT03078855|Biological|Rituximab|Administered weekly x 4
15974451|NCT03078855|Other|Placebo|methylcellulose
15974387|NCT03079245|Other|Education Plus (E+)|Education Plus was an intervention developed by the study team based on the Center for Disease Control (CDC) 12 Step Campaign to Prevent Antimicrobial Resistance in Healthcare Settings. The study team provided Education Plus quarterly to prescribers at the three sites (NICU A, B, C) randomized to this intervention. Examples of topics presented were an overview of antimicrobial stewardship principles, epidemiology of healthcare-associated infections (HAIs), prevention of surgical site infections, antimicrobial susceptibility testing, and pharmacokinetic principles. Educational formats included didactic lectures, participation via the audience response system, case vignettes, and panel discussions.
15974388|NCT03079245|Other|Clinical Decision Support|The CDS tool was an intervention developed in consultation with neonatologists and pediatric infectious disease physicians from NICU A and B. Algorithms for empiric and targeted antimicrobial therapy for common pathogens and common clinical scenarios using local antimicrobial susceptibility patterns were developed. The CDS tool also provided additional components to facilitate antimicrobial prescribing, e.g., patient weight, day of life, previous culture results, antimicrobial orders, and selected laboratory results including white blood cell and platelet count, C-reactive protein, creatinine, and therapeutic drug levels. NICUs A and B also received E+
15974389|NCT03079245|Other|Prescriber Audit and Feedback|The prescriber audit and feedback (PAF) intervention was developed by the study team which held focus groups with neonatologists at NICU A (the site randomized to this intervention) to determine the feedback parameters and feedback format as previously described. Neonatologists at NICU A were provided aggregated prescribing data bimonthly that described inappropriate use as described below and prolonged therapy (>7 days) for culture-negative late onset sepsis. NICU A also received CDS and E+.
15974390|NCT03079232|Device|OCTAV Patient|In vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient.
15974391|NCT03079232|Device|OCTAV Control group|In vivo skin imaging performed by placing the tip of the OCTAV device directly in slight contact with the skin of the patient.
15974392|NCT03079219|Drug|Experimental drug: Aprepitant|Day 1: 125mg QD; Day 2 to Day 3: 80mg QD
15974393|NCT03079219|Drug|Experimental drug: Ondansetron|Day 1: 8mg BD, First dose 8mg, Second dose 8mg, 8 hours after first dose
15974394|NCT03079219|Drug|Experimental drug: Dexamethasone|Day 1: 12mg QD
15974395|NCT03079219|Drug|Experimental drug: Olanzapine|Day 1 to Day 5: 10mg QD
15974396|NCT03079219|Drug|Standard: Aprepitant|Day 1: 125mg QD, Day 2 to Day3: 80mg QD
15974397|NCT03079219|Drug|Standard: Ondansetron|Day 1: 8mg BD, First dose 8mg, second dose 8mg, 8 hours after first dose
15974398|NCT03079219|Drug|Standard: Dexamethasone|Day 1: 12mg QD ; Day 2 to Day 3: 4mg BD
15974399|NCT03079206|Diagnostic Test|Food challenge|food challenge with hazelnut
15974400|NCT03079206|Diagnostic Test|skin testing|Skin testing with hazelnut extract
15974401|NCT03079206|Diagnostic Test|blood sampling|blood sampling to perform basophile activation tests
15974402|NCT03079180|Other|Strength training at 80% 1RM|Detailed in Arms section's
15974403|NCT03079180|Other|Strength training at 55% 1RM|Detailed in Arms section's
15974404|NCT03079167|Drug|Epoetin Alfa|
15974405|NCT03079167|Drug|Normal saline|
15974406|NCT03079154|Other|Teacher-led MBCT course|9 x 2 hour group sessions following national guidelines for mindfulness-based cognitive therapy
15974407|NCT03079154|Other|Self-guided MBCT course|9 weeks of self-guided mindfulness-based cognitive therapy, following an audiobook covering the same material and exercises as the teacher-led intervention
15974408|NCT03079141|Drug|Eplerenone|"Patients will receive 25 milligrams oral eplerenone once daily for a week, and - when no abnormalities during blood testing for potassium and renal clearance can be detected both before treatment and during the first week of treatment - will receive 50 milligrams oral eplerenone for another 11 weeks thereafter.
~When patients are randomized to the eplerenone arm of this study, they will receive this treatment as a first cCSC treatment. Moreover, eplerenone treatment can be initiated in patients in whom SRF is still present on OCT at the Evaluation Visit at 3 months after PDT treatment."
15974409|NCT03079141|Other|Photodynamic therapy|"In the PDT treatment arm, all patients will receive an intravenous drip through which half-dose (3 mg/m2) verteporfin (Visudyne®) is administered, with an infusion time of 10 minutes. At exactly 15 minutes after the start of the infusion, PDT laser treatment is performed with standard 50 J/cm2 fluency, a wavelength of 689 nm, and a treatment duration of 83 seconds.
~When patients are randomized to the PDT arm of this study, they will receive this treatment as a first cCSC treatment. Moreover, PDT can be performed in patients in whom SRF is still present on OCT at the Evaluation Visit at 3 months after the start of eplerenone treatment."
15974410|NCT03079128|Behavioral|Intervention|Weight Watchers Intervention
15974411|NCT03079115|Drug|High-dose Atorvastatin|high-dose Atorvastatin (80 mg QD from 3 days before to 3 days after CAS, and thereafter 20mg QD until 30 days after CAS)
15974412|NCT03079115|Drug|Conventional-dose Atorvastatin|conventional-dose Atorvastatin(20 mg QD from 3 days before to 30 days after CAS).
15974413|NCT03079102|Drug|Nitric Oxide|An endogenous gaseous signaling molecule which stimulates soluble guanylate cyclase and may act via S-nitrosation, nitrite/nitrate or nitrated fatty acid formation.
15974414|NCT03079102|Drug|Nitrogen|Nitrogen is the carrier gas (vehicle) for iNO. Subjects receiving placebo will receive equivalent doses of nitrogen.
15974415|NCT03079089|Drug|Sequential Packaging (SET)|Sequential chemotherapy: - Thiotepa 5 mg/kg/day for 1 day (D-13) -Cyclophosphamide 400 mg/m²/day for 4 days (J-12 to J-9)- Etoposide 100 mg/m²/day for 4 days (J-12 to J-9) Repos days J-8 and J-6 Reduced-intensity conditioning (RIC)-Fludarabine 30 mg/m²/day for 5 days (J-5 to D-1)- Busulfan IV 3.2 mg/kg/day for 2 days (J-5 and J-4)- Anti-lymphocyte serum (Thymoglobuline) 2.5 mg / kg / day for 2 days (J-3 and J-2)
15974416|NCT03079089|Drug|Transfusion graft|Graft of peripheral stem cells is preferred at DO
15974417|NCT03079089|Drug|Prevention of GVHD|"Cyclophosphamide 50mg/ kg/day on days D + 3 and D + 5 - Cyclosporine A (CSA; 3 mg / kg / day IV from D+6)
~Mycophenolate mofetil (MMF; 30 mg/kg/ day, maximum x2 1g / day from day J+6)"
15974418|NCT03079089|Drug|Care supports|According to the protocols of each center
15974452|NCT03078842|Dietary Supplement|Zinc tablets, 20 mg per day|Participants will receive rehydration, dietary counseling, and 1 tablet per day for 14 days of zinc-tablets, each of which contains 20 mg of zinc
15974742|NCT03076827|Procedure|Hemi-arthroplasty|Hemi-arthroplasty starts in the morning in group A and starts in the afternoon in group P.
15974419|NCT03079089|Drug|Lymphocyte injection of prophylactic donor (PDLI)|"According to the protocols of each center. In the absence of clinical indication against-disease (GVHD), phasing MMF between days D + 35 and D + 56, then phasing APF between D + 62 and D + 90
~- PDLI: 3 injections from the D + 120 patients who discontinued immunosuppressive therapy for ≥ 1 month and having no active GVHD or history of acute GVHD grade> II."
15974420|NCT03079076|Drug|Bupivacaine|20 ml %0,25 bupivacaine bilaterally
15974421|NCT03079076|Drug|Saline|2 ml saline subcutaneously bilaterally
15974422|NCT03079063|Biological|Eptacog alfa, biosimilar|Either a single dose of eptacog alfa biosimilar 30 μg/kg and one single dose of NovoSeven 30 μg/kg, or vice versa, with doses separated by a washout period. Then, in an open follow up phase of 12 months, for every bleeding episode eptacog alfa biosimilar 30 μg/kg, on demand, for one of more days until resolution of bleeding, based on the Investigator's decision - or - prophylaxis with eptacog alfa biosimilar, with dose, frequency, and duration of treatment based on the Investigator's decision. The modality of treatment (on demand or prophylaxis) will be decided by the Investigator.
15974423|NCT03079063|Biological|Novoseven|Either a single dose of eptacog alfa biosimilar 30 μg/kg and one single dose of NovoSeven 30 μg/kg, or vice versa, with doses separated by a washout period.
15974424|NCT03079050|Drug|Dexlansoprazole 60 MG|This drug will be given to 34 random patients during the 2nd, 3rd, and 4th weeks of the month of Ramadan to assess its ability to relieve GERD symptoms
15974425|NCT03079037|Device|Stimulation|Traditional deep brain stimulation
15974426|NCT03079024|Device|Targeted Cognitive Training|"Auditory Training Module (20 hours): exercises designed to improve speed and accuracy of auditory processing while engaging working memory and cognitive control. Exercises adjust difficulty level to maintain an ~80% correct performance. Exercises contain stimuli spanning the acoustic organization of speech. In the initial stages, stimuli exaggerate the rapid temporal transitions by increasing amplitude and stretching in time. The exaggeration is gradually removed so that by the end, all stimuli have characteristics representative of real-world speech.
~Social Cognition Module (10 hours): exercises designed to improve core deficits of social cognition in psychosis. Exercises apply principles of implicit learning to restore capacity to process and utilize socially-relevant information, and includes training to improve perception of affect (visual/vocal) and social cues (faces, gazes, social situations), theory of mind, self-referential style, emotion labeling and working memory."
15974427|NCT03079024|Device|General Cognitive Exercises|The GCE will focus on executive dysfunction, as this domain is a significant, functionally important area of deficit in schizophrenia and has been the target of many previous studies. We will train this domain using a suite of engaging, adaptive web-based exercises that target executive function, intelligence, and spatial navigation developed by Posit Science. The exercises will be provide engaging, adaptive training as described in the Targeted Cognitive Training.
15974428|NCT03079011|Drug|Palbociclib 125mg|Palbociclib 125 mg once daily for 21 days followed by 7 days off to complete a 28-day cycle
15974429|NCT03079011|Drug|Aromatase Inhibitors|Letrozole: 2.5 mg once daily on a continuous scheme (tablets, per os) Anastrozole:1 mg once daily on a continuous scheme (tablets , per os) Exemestane: 25 mg once daily on a continuous scheme (tablets, per os)
15974430|NCT03079011|Drug|Fulvestrant Injectable Product|500 mg by intramuscular injection on days 1 and 15 of cycle one and then on day one of each subsequent cycle (28 days)
15974431|NCT03078998|Device|Leap Motion Based Exercises|Game based exercise
15974432|NCT03078985|Procedure|ablation for typical atrial flutter|Typical atrial flutter is treated by catheter ablation.
15974433|NCT03078985|Device|catheter ablation with study device|The study device is used inside the MRI environment to localize the cavotricuspid isthmus (CTI). The CTI is then treated with radiofrequency energy to achieve complete isthmus block.
15974434|NCT03078959|Other|immunohistochemistry|Samples will be stained using the SP263 antibody clone against PD-L1
15974435|NCT03078946|Drug|Dexmedetomidine Hydrochloride|30 patients received a loading dose of 1 μg/kg dexmedetomidine (Precedex; Hospira, Precedex 200 mcg/2 ml, Hospira. Inc, Lake Forest, USA) diluted in 100 ml 0.9% saline infused over 10 min immediately postoperative, followed by continuous infusion of 0.2- 0.7 μg/kg/h
15974436|NCT03078946|Drug|Morphine and Midazolam|30 patients received morphine in a dose of 10-50μg/ kg/hr as an analgesic (Morphine Sulphate ampoule; 10 mg/ 1ml, Misr Co.- Egypt) with midazolam in a dose of 0.05mg/kg up to 0.2 mg/kg (Dormicum; Roche; USA; ampoule containing 15 mg/3 ml mixed in sugar-free apple juice limiting the total volume mixed with a double volume of apple juice) repeated as needed.
15974437|NCT03078933|Device|Standard of Care|Standard of Care arm which includes wound care, dressings and debridement.
15974438|NCT03078933|Device|Nitric Oxide Therapy 2x week 6 min. plus standard of care|Active Therapy Nitric Oxide delivered topically to the wound twice a week for 6 minutes plus standard of care. Standard of care includes wound care, dressings and debridement.
15974439|NCT03078933|Device|Nitric Oxide Therapy 2x week 12 min. plus standard of care|Active Therapy Nitric Oxide delivered topically to the wound twice a week for 12 minutes plus standard of care. Standard of care includes wound care, dressings and debridement.
15974440|NCT03078933|Device|Nitric Oxide Therapy 4x week 6 min. plus standard of care|Active Therapy Nitric Oxide delivered topically to the wound four times a week for 6 minutes plus standard of care. Standard of care includes wound care, dressings and debridement.
15974441|NCT03078933|Device|Nitric Oxide Therapy 4x week 12 min. plus standard of care|Active Therapy Nitric Oxide delivered topically to the wound four times a week for 12 minutes plus standard of care. Standard of care includes wound care, dressings and debridement.
15974442|NCT03078920|Device|Naída CROS|At fitting Naída CROS and a loaner Naída CI processor are used for the duration of the study. The fitting software allows to enable a HIBAN link between the CI processor and the Naída CROS. The fitting of the CI processor is based on the clinical programming of the subject. No changes are made to the fitting parameters unless the subject requests changes. The fitting is done according to the clinical routine. The Naída CROS is pre-configured to communicate with the Naída CI when switched on.
15974443|NCT03078907|Drug|Selexipag|Film-coated tablets for oral use; one tablet (200 mcg) to eight tablets (1600 mcg) are administered depending on the individual tolerability.
15974444|NCT03078907|Drug|Placebo|Matching film coated tablets
15974445|NCT03078894|Diagnostic Test|Zika|Zika Diagnostic test
15974446|NCT03078894|Diagnostic Test|Chikagunya|Chikagunya Diagnostic test
15974447|NCT03078894|Diagnostic Test|Dengue|Dengue Diagnostic test
15974453|NCT03078842|Dietary Supplement|Zinc tablets, 10 mg per day|Participants will receive rehydration, dietary counseling, and 1 tablet per day for 14 days of zinc-tablets, each of which contains 10 mg of zinc
15974454|NCT03078842|Dietary Supplement|Zinc tablets, 5 mg per day|Participants will receive rehydration, dietary counseling, and 1 tablet per day for 14 days of zinc-tablets, each of which contains 5 mg of zinc
15974455|NCT03078829|Drug|Treatment with a GnRh agonists|All patients will be treated with GnRH agonists
15974456|NCT03078816|Device|Activa PC Primary Cell Neurostimulator - (Model 37601)|Deep Brain Stimulator system will be implanted using standard neurosurgical techniques. The device will deliver constant stimulation to the thalamus using settings programmed by study team.
15974457|NCT03078816|Device|Activa RC Rechargeable Neurostimulator - (Model 37612)|Deep Brain Stimulator system will be implanted using standard neurosurgical techniques. The device will deliver constant stimulation to the thalamus using settings programmed by study team.
15974458|NCT03078816|Device|Activa SC Single Cell Neurostimulator (Models 37602/37603)|Deep Brain Stimulator system will be implanted using standard neurosurgical techniques. The device will deliver constant stimulation to the thalamus using settings programmed by study team.
15974459|NCT03078816|Device|DBS Lead - (Model 3387|Deep Brain Stimulator system will be implanted using standard neurosurgical techniques. The device will deliver constant stimulation to the thalamus using settings programmed by study team.
15974460|NCT03078816|Device|DBS Extension - (Models 37085/6)|Deep Brain Stimulator system will be implanted using standard neurosurgical techniques. The device will deliver constant stimulation to the thalamus using settings programmed by study team.
15974461|NCT03078816|Device|Patient Programmer - (Model 37642)|Deep Brain Stimulator system will be implanted using standard neurosurgical techniques. The device will deliver constant stimulation to the thalamus using settings programmed by study team.
15974462|NCT03078816|Device|Test Stimulator - (Model 3625)|Deep Brain Stimulator system will be implanted using standard neurosurgical techniques. The device will deliver constant stimulation to the thalamus using settings programmed by study team.
15974463|NCT03078816|Device|N'Vision Clinician Programmer - (Model 8840)|Deep Brain Stimulator system will be implanted using standard neurosurgical techniques. The device will deliver constant stimulation to the thalamus using settings programmed by study team.
15974464|NCT03078816|Device|N'Vision Software Application Card - (Model 8870)|Deep Brain Stimulator system will be implanted using standard neurosurgical techniques. The device will deliver constant stimulation to the thalamus using settings programmed by study team.
15974465|NCT03078803|Biological|Fecal Microbiota Transplant (FMT)|FMT delivered by colonoscopy and oral capsules
15974466|NCT03078803|Biological|Placebo|Transfer of water only
15974467|NCT03078790|Device|iPad|a 10 minute electronic guided deep breathing module offered via an iPad
15974468|NCT03078777|Drug|Fexofenadine|Fexofenadine will be administered to patients.
15974469|NCT03078764|Other|Mobile health system|Patients will receive weekly automated IVR telephone calls for 12 weeks to assess their glycemic symptoms, medication adherence, dietary consumption, physical activity, sleep, and foot care. These 5-10 minute calls will follow a standardized Thai language IVR script developed specifically for this study.
15974470|NCT03078764|Other|E-mail reports and technical support for mHealth system|Nurses will also receive a technical troubleshooting guide, and have similar access to live telephone technical support. Once their patients' calls begin, nurses will begin receiving weekly e-mail reports summarizing each patients' assessment results, any active self-management problems the patients reported, and suggested strategies for supporting the patient's self-management.
15974471|NCT03078751|Drug|Ribociclib|"Ribociclib 600 mg daily on days 1 to 21 of a 28-day cycle for 26 cycles (approximately 24 months).
~Ribociclib was supplied in the form of 200 mg film-coated tablets taken by mouth."
15974472|NCT03078751|Drug|Adjuvant endocrine therapy|Letrozole 2.5 mg by mouth daily, or anastrozole 1 mg by mouth daily, exemestane 25 mg by mouth daily, tamoxifen 20 mg by mouth daily, for a total duration of at least 60 months. In premenopausal women, a GnRH agonist administered every 28 days.
15974473|NCT03078751|Drug|Placebo|"Placebo 600 mg daily on days 1 to 21 of a 28-day cycle for 26 cycles (approximately 24 months).
~Placebo was supplied in the form of 200 mg film-coated tablets taken by mouth."
15974474|NCT03078738|Drug|OMT-28|OMT-28 is a fully synthetic small molecule that belongs to the family of 17,18-epoxyeicosatetraenoic acids (17,18-EEQ) analogs, a natural metabolite of the omega-3 fatty acid eicosapentaenoic acid (EPA).
15974475|NCT03078738|Other|Matching Placebo|Microcrystalline cellulose
15974476|NCT03078725|Drug|Glyburide|oral hypoglycemic agent
15974477|NCT03078725|Drug|Metformin|oral hypoglycemic agent
15974478|NCT03078712|Other|Peripheral Perfusion guided resuscitation|Sequential approach with fluids (guided by dynamic predictors of fluid responsiveness), vasopressors titration, and inodilators according to peripheral perfusion.
15974479|NCT03078712|Other|Lactate guided resuscitation|Sequential approach with fluids (guided by dynamic predictors of fluid responsiveness), vasopressors titration, and inodilators according to lactate decrease.
15974480|NCT03078699|Radiation|stereotactic body radiation therapy|A total radiation dose of 35-50 Gy was delivered to the 50% isodose line covering at least 95% of the PTV (3.5-5Gy/fraction), and a total radiation dose of 49-70 Gy was delivered to the 70% isodose line covering at least 95% of GTV (4.9-7 Gy/fraction).
15974481|NCT03078686|Procedure|tSVF by lipoaspiration|Lipoaspiration Harvest tSVF closed syringe microcannula harvest, Tulip GEMS microcannula syringe system
15974482|NCT03078686|Procedure|PRP Concentration|Preparation of High Density PRP Centrifugation per manufacturer directive, Emcyte II PurePRP System
15974483|NCT03078686|Procedure|Emulsification tSVF|Preparation of emulsified tSVF harvested adipose; Use of ACM Device; Micronization of tSVF through Sterile Screen
15974484|NCT03078686|Procedure|cSVF isolation and concentration|Healeon Centrifuge (CC1000) enzymatic digestion, incubation, isolation and neutralization to prepare cSVF concentrates
15974485|NCT03078686|Procedure|cSVF in Normal Saline IV|cSVF + NS for IV Placement
15974486|NCT03078673|Other|training intervention, motor skill training|cross country specific motor skill strength training
15974487|NCT03078673|Other|training intervention, maximal strength training|general maximal strength training
15974488|NCT03078673|Other|control group|regular training
15974489|NCT03078660|Behavioral|Smartphone Application|The smartphone Application generates a shopping list for participants, based on a low caloric diet (energy requirements minus 500 kcals), taking into consideration the Dietary Guidelines for Americans' recommendations and also considering the available budget for each shopping event and the weekly discounts from major supermarkets.
15974490|NCT03078660|Behavioral|Traditional Nutritional Counseling|Participants will have a face-to-face counseling session with a registered dietitian, who will provide recommendations for a low caloric diet (energy requirements minus 500 kcals) using the food group sheets from the Dietary Guidelines for Americans.
15974491|NCT03078647|Device|Profound|The main intent of the Profound Dermal and Subdermal cartridges for cellulite treatment is to utilize a minimally-invasive approach to directly deliver radiofrequency (RF) energy into tissue through pairs of micro-electrode needles and use temperature sensors within the needles to reliably create fractional thermal injuries within the skin.
15974492|NCT03078634|Other|Multi-disciplinary clinic model|Clinic model incorporating multiple disciplines for the treatment of functional gut disorders. Disciplines include: gastroenterologists, psychiatrists, psychologists, hypnotherapists, behavioural therapists and dieticians. End of clinic case conference involving clinical disciplines will also occur to coordinate care.
15974493|NCT03078634|Other|Standard outpatient care|Standard care provided in outpatient clinics staffed by GI doctors only
15974494|NCT03078621|Biological|Stem Cell Therapy|Intravenous and Intrathecal transplantation of purified autologous bone marrow-derived stem cells and mesenchymal stem cells.
15974495|NCT03078608|Behavioral|Mindfulness meditation program (administered via mobile app)|Mobile app-based/online mindfulness meditation program
15974496|NCT03078608|Behavioral|Progressive muscle relaxation (via mobile app)|Mobile app-based/online progressive muscle relaxation program
15974497|NCT03078582|Drug|Zilucoplan (RA101495)|0.3mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
15974498|NCT03078569|Drug|Testosterone gel|treatment with testosterone gel
15974499|NCT03078556|Drug|Dolutegravir|Single dose of DTG 50 mg tablet along with 3TC (EPIVIR) tablet will be given to randomized subjects in parts 1 and 2 with 240 mL of room temperature water. DTG will be a white, film coated, round tablet engraved with SV 572 on one side and 50 on the other side.
15974500|NCT03078556|Drug|Lamivudine|"Single dose 3TC (commercial name: EPIVIR) 300 mg tablet along with DTG tablet will be given to randomized subjects in parts 1 and 2 with 240 mL of room temperature water.<br>3TC will be gray, diamond shaped tablet, engraved GX EJ7 on one side and plain on the other side."
15974501|NCT03078556|Drug|Dolutegravir + Lamivudine FDC Formulation 1|Single dose of DTG 50 mg combined with 3TC 300 mg in a FDC formulation 1 tablet will be administered to randomized subjects in treatment periods 1 and 2 (under fasted state) of Part 1 and the first 16 subjects in treatment period 3 (under fed) of Part 1 with 240 mL of room temperature water. &lt;br&gt;FDC formulation 1 tablets will be oval, biconvex, white, film coated tablet engraved 'SV H7I' on one face.
15974502|NCT03078556|Drug|Dolutegravir + Lamivudine FDC Formulation 2|Single dose of DTG 50 mg combined with 3TC 300 mg in a FDC formulation 2 tablet will be administered to randomized subjects in treatment periods 1 and 2 (under fasted state) and the first 16 subjects in treatment period 3 (under fed) of Part 2 with 240 mL of room temperature water. &lt;br&gt;FDC formulation 2 tablets will be oval, biconvex, white, film coated tablet engraved 'SV 13N' on one face.
15974503|NCT03078543|Device|ANTHEM™ PS Total Knee System implant|"The ANTHEM™ PS Total Knee System is a comprehensive system which allows surgeons to address simple to complex knee arthroplasties. The ANTHEM™ PS Total Knee System consists of the following components:
~Cobalt-Chrome (Co-Cr) femoral components - Posterior stabilised
~Titanium primary tibial components
~Posterior-stabilised ultra-high molecular weight polyethylene (UHMWPE)
~Polyethylene patella components The resulting product is sufficient to accommodate a wide range of clinical applications."
15974504|NCT03078530|Drug|Placebo|This is a pill with inactive ingredients
15974505|NCT03078530|Drug|Visbiome|This is a probiotic mixture available to randomized study participants, starting with subject 29
15974506|NCT03078530|Drug|VSL#3|This is a probiotic mixture available to the first 28 subjects randomized to the study
15974507|NCT03078517|Device|I-gel|After the induction of anesthesia, i-gel is inserted along the palatopharyngeal curve.
15974508|NCT03078517|Device|Laryngeal mask airway protector|After the inudction of anesthesia, laryngeal mask airway protector is inserted along the palatopharyngeal curve, and the cuff is inflated.
15974509|NCT03078504|Device|continuous renal replacement therapy using System One (TM) setup (Nxstage)|Participants who have been prescribed continuous renal replacement therapy will have hemodynamic parameters measured at various blood flow rates
15974510|NCT03078491|Other|eCGM (enhanced CGM)|Glucose (CGM and Bluetooth BG meter), insulin (pump or Bluetooth insulin pen) and activity data will be automatically uploaded via the subjects' tablet computers, and analyzed by the CDS. The CDS will, if indicated generate adjustable insulin dosing recommendations that will compensate for different insulin requirements following high vs low activity days. The recommendations of the CDS will be used by the clinical team in their therapeutic decision-making about insulin dosing adjustments at the scheduled study follow up visits and the remote visits between these in-person visits. In addition, study staff will provide recommendations regarding hypoglycemic warning symptoms, causes, and appropriateness of treatment.
15974511|NCT03078478|Drug|Insulin degludec|For subcutaneous (s.c., under the skin) injection once daily
15974512|NCT03078478|Drug|Insulin glargine|For subcutaneous (s.c., under the skin) injection once daily
15974513|NCT03078465|Drug|Ticagrelor|Daily administration of ticagrelor 180mg for 12 months
15974514|NCT03078465|Drug|Clopidogrel|Daily administration of clopidogrel 150mg for 12 months
15974515|NCT03078452|Device|Power drill|Undergo bone marrow biopsy using power drill
15974516|NCT03078452|Device|Jamshidi needle|Undergo bone marrow biopsy using Jamshidi needle
15974551|NCT03078192|Drug|GE-141, Hyperpolarized 129Xenon gas|XeMRI scans will provide 3D images of ventilation and gas exchange. Subjects will inhale HP 129Xe from the dose delivery bags. Then the subject will be moved into the scanner and they will undergo basic 1H localizer and anatomical scans. Once localization is complete, subjects will under-go several MRI scans after inhalation of HPXe
15974552|NCT03078192|Device|MRI|Perform MRI scans with administration of GE-141, Hyperpolarized 129Xenon
15975834|NCT03068260|Drug|Saline|30 ml saline 0,375% administered on each side as bilateral TQL blocks
15974517|NCT03078439|Other|Medical and neuropsychological assessments|"Assessment of health status and development will be performed in specific centers at 5 and a half years. This check-up includes a complete medical examination to look for visual, hearing, motor impairment and health problems, and psychological tests using standardized tools (WPPSI IV ((Wechsler Preschool and Primary Scales Intelligence)) and NEPSY 2 tests) to assess cognitive development of very preterm children.
~A parental questionnaire will be fulfilled to investigate family's social conditions, maternal health, autism spectrum disorders (Social Communication Questionnaire), the child's quality of life and behavioral development (Strengths and Difficulties Questionnaire)."
15974518|NCT03078426|Device|MRI|It will be performed on a 1.5-Tesla MR scanner (MAGNETOM Avanto, Siemens Healthcare, Erlangen, Germany). Acquisitions will be obtained in the axial plane using a 12-channel thorax/spine coil. Investigators will use previously published sequence parameters for each MRI sequence. PETRA will be acquired under free-breathing with respiratory gating at functional respiratory capacity.
15974519|NCT03078426|Other|Thoracic HRCT (standard reference)|It will be performed on a 16 (Sensation 16, Siemens®) or 64 channels (Definition 64, Siemens®), without contrast agent injection.
15974520|NCT03078400|Drug|SPL-108|Subcutaneous injection of 150 mg administered either one time or two times per day.
15974521|NCT03078387|Diagnostic Test|imaging|imaging before and after treatment
15974522|NCT03078374|Drug|Warfarin|Reduced dosage to obtain lower INR range
15974523|NCT03078361|Other|Immunochemical Fecal Occult Blood Test (I-FOBT) Kit|Both intervention groups will receive an I-FOBT kit (by study coordinator) with verbal and written instructions in Spanish on how to complete the stool sampling at home within 1 week, and mail the completed kit in the pre-addressed, postage paid mailer. Patients with abnormal results will receive a call explaining the meaning of an abnormal I-FOBT and encouraging them to take specific next steps.
15974524|NCT03078361|Behavioral|LATINOS CARES Toolkit|DVD + photonovella booklet), about colorectal cancer screening (CRCS) targeted for a Latino medically underserved population.
15974525|NCT03078361|Behavioral|Standard Intervention|Standard intervention (CDC brochure) on colorectal cancer screening in community health clinics.
15974526|NCT03078348|Other|Fecal Immunochemical Test (FIT) Kit|Free FIT Kits distributed at study entry.
15974527|NCT03078348|Behavioral|Culturally targeted Photo Novella Booklet|Culturally targeted Photo Novella Booklet + culturally targeted reminders. Print materials developed by the Centers for Disease Control and Prevention (CDC)) to provide information about CRC, importance of screening and available screening tests. Timed reminder letters and/or emails intended as a cue to action and as educational boost to facilitate participant screening decision making and screening uptake.
15974528|NCT03078348|Behavioral|Screen for Life Brochure|Screen for Life Brochure + standard reminders. Print materials developed by the Centers for Disease Control and Prevention (CDC)) to provide information about CRC, importance of screening and available screening tests. Timed reminder letters and/or emails intended as a cue to action and as educational boost to facilitate participant screening decision making and screening uptake.
15974529|NCT03078335|Other|Glove based care|Described in Experimental Arm: Glove based care
15974530|NCT03078335|Other|Standard of Care - Hand Hygiene|Hand Hygiene - hand washing with soap and water, or alcohol based hand rub
15974531|NCT03078322|Drug|AV-101|Oral capsules taken once daily (in addition to open-label treatment with a commercially available antidepressant)
15974532|NCT03078322|Drug|Placebo|Oral capsules taken once daily (in addition to open-label treatment with a commercially available antidepressant)
15974533|NCT03078309|Drug|cannabis|single dose sublingual cannabis (THC:CBD 1:1, THC:CBD 1:40)
15974534|NCT03078296|Other|survey respondents|all survey participants will be asked to complete a questionnaire
15974535|NCT03078283|Other|high-fiber food type|In 3 successive experiments, usual diet will be supplemented with snack foods containing fiber of plant, fruit or grain origin.
15974536|NCT03078270|Drug|botulinum toxin A|Single treatment visit for 5 injections of botulinum toxin A, 40 units (for females) and 50 units (for males)/
15974537|NCT03078270|Other|Placebo|single treatment visit for 5 injections of normal saline
15974538|NCT03078257|Drug|tirofiban in PV|"a loading dose of 10ug/kg tirofiban is given in 3 min through PV,followed by a maintenance dose of 0.15ug/kg*min for 48h.
~(clopidogrel 600 mg+aspirin( ASA) 300 mg)x1 day."
15974539|NCT03078257|Drug|tirofiban in IC|"a loading dose of 10ug/kg tirofiban is given in 3 min through IC,followed by a maintenance dose of 0.15ug/kg*min for 48h.
~(clopidogrel 600 mg+ ASA 300 mg)x1 day."
15974540|NCT03078257|Drug|antiplatelet thrombolysin|"a loading dose of 5 IU/60kg in 5 min through PV,followed by a maintenance dose of 0.002 IU/kg/h for 48h.
~(clopidogrel 600 mg+ ASA 300 mg)x1 day."
15974541|NCT03078257|Drug|placebo|"a loading dose of 5 IU/60kg in 5 min through PV,followed by a maintenance dose of 0.002 IU/kg/h for 48h.
~(clopidogrel 600 mg+ ASA 300 mg)x1 day."
15974542|NCT03078257|Drug|Clopidogrel|loading dose of 300 mg clopidogrel followed by a maintenance dose of 75 mg/d for at least 5 days
15974543|NCT03078257|Drug|Aspirin|loading dose of 300 mg aspirin followed by a maintenance dose of 100 mg/d for at least 5 days.
15974544|NCT03078257|Drug|Clopidogrel|loading dose of 600 mg clopidogrel followed by a maintenance dose of 75 mg/d for at least 5 days
15974545|NCT03078244|Other|N/A, observational study|
15974546|NCT03078231|Procedure|Color fundus photography|Subjects will undergo fundus photography before and after administration of mydriatic agent.
15974547|NCT03078231|Drug|Mydriatic Agent|Subjects will be administered mydriatic medication to dilate their pupils.
15974548|NCT03078218|Diagnostic Test|Pulse oximetry|The tool evaluated will be the assumption of peripherical arterial oxygen saturation by pulse oximetry. The pulse oximetry will identify hypoxemic CCHD and hypoxemic non-cardiac disease before discharge.The test will be realised before 24 hours of life in a newborn aged at least of 35 weeks of gestation.
15974549|NCT03078205|Other|The dual therapy|TCM prescriptionⅡof cultivated emotion and assisted reproduction +auricular acupoint therapy
15974550|NCT03078205|Other|The triple therapy|TCM prescriptionⅡof cultivated emotion and assisted reproduction + auricular acupoint therapy+ retention enema of TCM
15974585|NCT03077958|Procedure|Total Knee Replacement (2 different design)|Patients will randomely receive either Attune or PFC Sigma TKR
15974586|NCT03077945|Behavioral|heart rate variability biofeedback and cognitive reappraisal|
15974587|NCT03077945|Behavioral|control tasks|
15974553|NCT03078179|Dietary Supplement|Commercial Dairy Cow Milk|After obtaining parent´s informed consent and the baseline examination, from 3 to 5 years old, will start commercial dairy cow milk intake without probiotic (placebo) for 3 months. Clinical and microbiological testing of saliva at baseline and at the end will be performed. Differences in salivary pH (before and after a sugar solution), remineralization and demineralization in early Stage Decay and quantification of Streptococci of the mutans group.
15974554|NCT03078179|Dietary Supplement|Commercial Cow Milk with Probiotic|The children will initiate the milk intake with probiotic one week after having ingested the milk without probiotics. They will drink the milk with probiotic for 3 months. Clinical and microbiological testing of saliva will be performed. Clinical and microbiological testing of saliva at baseline and at the end will be performed. Differences in salivary pH (before and after a sugar solution), remineralization and demineralization in early Stage Decay and quantification of Streptococci of the mutans group.
15974555|NCT03078153|Behavioral|Financial Incentive|Participants will receive a $50 gift card at 3- and 6- month follow-up visits.
15974556|NCT03078153|Behavioral|Social Media Group|Participants will be invited to a study Facebook group which will have links to PrEP information and provide a forum for participants to ask questions and communicate their experience with PrEP
15974557|NCT03078140|Dietary Supplement|Triferdine|Triferdine 1 tablet daily Start from 14 weeks of gestation until delivery
15974558|NCT03078140|Dietary Supplement|Triferdine/Ferli-6|"For the participants assigned to this group, urine iodine level will be checked first.
~For participants with normal urine iodine level, Ferli-6 1 tab daily will be given.
~For those with low urine iodine level, Triferdine 1 tab daily will be given. Medication will be started from 14 weeks of gestation until delivery."
15974559|NCT03078127|Other|Baseline (Huff-Cough alone)|"Subjects will provide two huffs (forced expiratory maneuver with open glottis) followed by a cough every six minutes for a total of six Huff-Coughs."
15974560|NCT03078127|Device|Oscillatory Positive Expiatory Pressure Device|Subjects will use an Areobika® branded OPEP device (10 breaths through highest tolerated resistance) prior to undergoing a Huff-Cough. Subjects will use the device six times every six minutes.
15974561|NCT03078127|Device|Whole-Body Vibration Platform|Subjects will be seated on a PowerPlate® whole-body vibration platform for 90 seconds prior to Huff-Cough. Six intervals on the platform will be completed six minutes apart.
15974562|NCT03078127|Device|High Frequency Chest Wall Oscillatory Vest|"Subjects will use TheVest® using a standardized Minnesota Protocol divided into six, four-minute segments, each followed by a Huff-Cough."
15974563|NCT03078114|Other|Spinal Manipulation|The subject will be asked to lay down and bend in a specific way. The clinician will apply force to certain areas to manipulate the spine.
15974564|NCT03078114|Other|Placebo Spinal Manipulation|The subject will be asked to lay down and bend in a specific way. The clinician will apply force to certain areas to simulate manipulating the spine.
15974565|NCT03078101|Drug|Empagliflozin 10 MG [Jardiance]|administered orally once daily
15974566|NCT03078101|Drug|Placebo Oral Tablet|administered orally once daily
15974567|NCT03078088|Drug|Tham|alkalinizer
15974568|NCT03078088|Drug|Saline|Placebo
15974569|NCT03078075|Drug|Naltrexone: Vivitrol®|Naltrexone: 380 mg vial, 4 intramuscular injections administered every 3 weeks
15974570|NCT03078075|Drug|Placebo (PLB) Injectable|Placebo: 4 intramuscular injections administered every 3 weeks
15974571|NCT03078075|Drug|Bupropion: Wellbutrin XL®|Bupropion: 450 mg oral dose daily
15974572|NCT03078075|Drug|Placebo (PLB) Oral|Placebo: once-daily oral placebo tablets
15974573|NCT03078062|Drug|Dexamethasone|Administration of a single-dose of intravenous dexamethasone 8 mg during spinal anesthesia
15974574|NCT03078062|Drug|Normal saline|Administration of a single-dose of Normal saline during spinal anesthesia
15974575|NCT03078036|Genetic|Germline BRCA Test (blood)|If unavailable from the patient medical records, gBRCA gene mutation status will be tested as aligned to local clinical practice using a blood sample obtained preferably during routine clinical practice. (Note: Blood samples may be shipped to a central laboratory for testing and storage, based on local regulations for shipment of blood samples.)
15974576|NCT03078036|Genetic|FoundationOne Dx Genomic Profile (archival Tumour Specimen)|"Archival tumour specimen will be requested from all patients in the informed consent, but is not required for study enrolment (optional consent). Where sufficient archival tumour specimen is available and patients have consented to tumour specimen testing, FoundationOne Dx genomic profiling may take place as follows:
~Tumour Specimen: Acceptable samples include formalin-fixed, paraffin embedded (FFPE) tissue (preferred) or FFPE specimens, including core needle biopsies, fine-needle aspirates and effusion cytologies.
~Tumour Testing (optional): archival tumour specimens, where available, will be tested for mutations in HRR genes including BRCA1 and BRCA2 and other genomic alterations using the FoundationOne Dx genomic profile."
15974577|NCT03078036|Other|Follow-up|"Patients who test positive for a gBRCA gene mutation, and/or sBRCA or other HRR gene mutations (optional testing), will be followed prospectively for assessment of treatment patterns and associated clinical outcomes up to 30-months.
~- Patients who test negative for gBRCA gene mutations, sBRCA and other HRR gene mutations, no further data will be collected post baseline. Patients presenting other genomic alterations that are identified by the FoundationOne Dx genomic profile will not continue beyond baseline as part of this study."
15974578|NCT03078023|Device|swallowed sponge device|Swallowed sponge: Subjects having a clinical upper endoscopy will be asked to swallow the sponge 2 hours prior to EGD
15974579|NCT03078010|Drug|Piperacillin-tazobactam|piperacillin-tazobactam (4.5 gm IV q 6 hrs)
15974580|NCT03078010|Drug|cefepime|(2 gm IV q 8 hrs)
15974581|NCT03077997|Behavioral|Space from Diabetes|Space from Diabetes is an internet-delivered cognitive behaviour therapy-based programme for symptoms of depression, anxiety, & diabetes distress in people with type 2 diabetes mellitus.
15974582|NCT03077984|Combination Product|Chinese medicine treatment|The cohort of Chinese medicine treatment uses its comprehensive program of TCM on the basis of treatment with western medicine, including Chinese Herbs, acupuncture and acupoint application therapies.
15974583|NCT03077971|Behavioral|ACT Self-Help|Self-Help Intervention Workbook using an Acceptance and Commitment Therapy approach
15974584|NCT03077971|Behavioral|ACT Self-Help with Telephone Support|Self-Help Intervention Workbook using an Acceptance and Commitment Therapy approach alongside weekly telephone support calls
15974588|NCT03077932|Other|App Development and Open Pilot|"Phase 1 (app development) will consist of: 1) development of the BetterOFF prototype; and 2) series of usability studies with patients interested in discontinuing opioid medication.
~Phase 2 (open pilot) will involve conducting a 12-week open pilot trial (n=20) to test the feasibility and acceptability of the BetterOFF app with patients tapering from opiate medication."
15974589|NCT03077919|Drug|Ropivacaine|0.5% ropivacaine
15974590|NCT03077919|Drug|Sham treatment|preservative-free normal saline
15974591|NCT03077906|Other|Medical Files data extraction|Medical Files data extraction
15974592|NCT03077893|Device|Active Provant Therapy System|Treatment with active Provant Therapy System
15974593|NCT03077893|Device|Inactive (sham) Provant Therapy System|Treatment with Inactive (sham) Provant Therapy System
15974594|NCT03077880|Procedure|intra-operatory measurement during implant placement|mucoperiosteal flap, soft tissue thickness measurement, implant insertion
15974595|NCT03077867|Procedure|sinus floor augmentation with bone graft|sinus floor augmentation with lateral approach with bone graft
15974596|NCT03077854|Radiation|Functional Lung Avoidance Thoracic Radiotherapy|"Chemoradiation for non-small cell lung cancer: 60 Gy in 30 once-daily fractions (Dose reduction to 54 Gy in 30 once-daily fractions is allowed)
~Radiation alone for non-small cell lung cancer: 60 Gy in 25 once-daily fractions (Dose reduction to 55 Gy in 25 once-daily fractions is allowed)
~Chemoradiation for small-cell lung cancer: 45 Gy in 30 twice-daily fractions"
15974597|NCT03077854|Radiation|Standard Thoracic Radiotherapy|"Chemoradiation for non-small cell lung cancer: 60 Gy in 30 once-daily fractions (Dose reduction to 54 Gy in 30 once-daily fractions is allowed)
~Radiation alone for non-small cell lung cancer: 60 Gy in 25 once-daily fractions (Dose reduction to 55 Gy in 25 once-daily fractions is allowed)
~Chemoradiation for small-cell lung cancer: 45 Gy in 30 twice-daily fractions"
15974598|NCT03077841|Other|Laboratory Biomarker Analysis|Correlative studies
15974599|NCT03077841|Radiation|Partial Breast Irradiation|Undergo hypofractionated partial breast irradiation
15974600|NCT03077841|Other|Questionnaire Administration|Ancillary studies
15974601|NCT03077828|Drug|Carboplatin|Given IV
15974602|NCT03077828|Drug|Etoposide|Given IV
15974603|NCT03077828|Drug|Ifosfamide|Given IV
15974604|NCT03077828|Other|Laboratory Biomarker Analysis|Correlative studies
15974605|NCT03077828|Biological|Pembrolizumab|Given IV
15974606|NCT03077815|Other|Systematically intermittent arm exercise|While holding a rubber ball for 5 minutes a day, together with strappy elastic compression arm veinElastic bandages defined for using this research provides of standard bandages, according to research personnel Guide, reached hand elbow near heart end 4 (2~6) cm at of arm local pressure strong 50 mm-Hg (+/-10 mm-Hg) (about equivalent to provides pressure strong 6.67 thousand PA (kPa), also about equivalent to 0.97 PSI (pound per square inch)), to reached 5 minutes arm movement Shi short reduced vein return, promotion pathway vein extended of effect
15974607|NCT03077802|Other|Modified Seldinger technique, Experienced group|This is a technique for central venous catheterization. We will use needle that is covered with guiding sheath. After desired vessel puncture, guiding sheath is instantly slid over the needle into the vessel. The needle is withdrawn, guidewire is advanced through the guiding sheath, central catheter is placed into the vessel. The procedure will be performed by experienced practitioners who are board-certified anesthesiologist staffs and have experience of more than 50 central venous catheterizations in both techniques.
15974608|NCT03077802|Other|Seldinger technique, Experienced group|This is a technique for central venous catheterization. The desired vessel is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn. Central catheter is then passed over the guidewire into the vessel. The procedure will be performed by experienced practitioners who are board-certified anesthesiologist staffs and have experience of more than 50 central venous catheterizations in both techniques.
15974609|NCT03077802|Other|Modified Seldinger technique, Inexperienced group|This is a technique for central venous catheterization. We will use needle that is covered with guiding sheath. After desired vessel puncture, guiding sheath is instantly slid over the needle into the vessel. The needle is withdrawn, guidewire is advanced through the guiding sheath, central catheter is placed into the vessel. This technique will be performed by inexperienced practitioners who are junior residents and have experience of less than 50 central venous catheterizations in both techniques.
15974610|NCT03077802|Other|Seldinger technique, Inexperienced group|This is a technique for central venous catheterization. The desired vessel is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn. Central catheter is then passed over the guidewire into the vessel. This technique will be performed by inexperienced practitioners who are junior residents and have experience of less than 50 central venous catheterizations in both techniques.
15974611|NCT03077802|Other|Long-axis technique|Ultrasound probe is placed parallel to the vessel trajectories and needle is advanced using in-plane approach.
15974612|NCT03077802|Other|Short-axis technique|Ultrasound probe is placed vertical to the vessel trajectories and needle is advanced using out-of-plane approach.
15974613|NCT03077789|Procedure|TRABECULOTOMY|Evaluation of the prognosis of different surgery in congenital glaucoma
15974614|NCT03077776|Procedure|Biopsy|Biopsy of primary tumour to be performed prior to initiation of neoadjuvant chemotherapy
15974615|NCT03077776|Procedure|Biopsy (optional)|[Optional] biopsy of primary tumour to be performed after 4 weeks of neoadjuvant chemotherapy
15974616|NCT03077776|Procedure|Biopsy (metastatic)|Biopsy of metastatic site to be performed at the time of relapse
15974617|NCT03077763|Drug|Sodium Nitrite|
15974618|NCT03077750|Drug|VBP-245 Topical Gel|Topical application BID
15974619|NCT03077750|Drug|Vehicle|Vehicle Control With No Active Pharmaceutical Ingredients
15974620|NCT03077737|Behavioral|Choose to Change|Population-based letter outreach automated via the electronic health record system and text messaging targeted to low-income smokers. Paired with automated electronic referral for proactive quitline treatment (behavioral counseling plus nicotine replacement therapy).
15974621|NCT03077737|Behavioral|Enhanced usual care|Enhanced usual care based on Ask, Advise and Refer in which an electronic referral for proactive quitline treatment (behavioral counseling plus nicotine replacement therapy) is made during a clinic visit.
15974622|NCT03077724|Drug|Fish oil|Fish oil supplementation
15974625|NCT03077711|Drug|Methenamine hippurate|antiseptic used in the prevention of recurrent UTIs. Estrogen cream may be prescribed if the patient is post-menopausal (but not as a part of this study).
15974626|NCT03077698|Drug|Sodium Cridanimod|The study will investigate the efficacy of Sodium Cridanimod in conjunction with progestin therapy in a population of subjects with endometrial cancer, who have failed progestin monotherapy or who have been identified as PrR negative.
15974627|NCT03077698|Drug|progestin therapy|The study will investigator the use of progestin therapy in conjunction with Sodium Cridanimod
15974628|NCT03077685|Drug|NanoPac®|Subjects with locally advanced pancreatic adenocarcinoma will receive intratumoral (ITU) NanoPac® (Sterile Nanoparticulate Paclitaxel) via endoscopic ultrasound-guided direct injection.
15974629|NCT03077659|Drug|NanoPac®|Subjects with prostate cancer scheduled for prostatectomy will have NanoPac® injected intratumorally under image guidance directly into the lobe of the prostate with the dominant lesion 4 weeks prior to prostatectomy.
15974630|NCT03077646|Behavioral|Be SMART|An educational campaign that is non-political reviewing gun safety measures for preventing firearm injuries in children. There is both a video and written materials reviewing the information. The acronym SMART stands for: Secure all guns in your home, Model responsible behavior, Ask about unsecured guns in other homes, Recognize the risks of teen suicide, Tell your peers to be SMART
15974631|NCT03077646|Behavioral|Control: TSE|"A video called Kids and Smoke Don't Mix and handouts on tobacco smoke exposure (TSE) developed by the New York state quit-line."
15974632|NCT03077646|Behavioral|Be SMART + MD review|"An educational campaign that is non-political reviewing gun safety measures for preventing firearm injuries in children. There is both a video and written materials reviewing the information. The acronym SMART stands for: Secure all guns in your home, Model responsible behavior, Ask about unsecured guns in other homes, Recognize the risks of teen suicide, Tell your peers to be SMART.
~After being presented to parents/guardians via video and handouts, this information will be reviewed in person with a Physician."
15974633|NCT03077633|Procedure|Cervical Cerclage placement|Cervical Cerclage placement
15974634|NCT03077633|Drug|Vaginal Progesterone|200mg tab of vaginal progesterone administered daily from time of randomization until delivery.
15974635|NCT03077620|Drug|Suvorexant|Participants will be given a sleep aid (10mg or 20mg suvorexant) at bedtime for two consecutive nights that they are spending in a research unit.
15974636|NCT03077620|Drug|Placebo|Participants will be given a placebo at bedtime for two consecutive nights that they are spending in a research unit.
15974637|NCT03077607|Drug|Talazoparib|Arm A: 0.5 mg oral dose Arm B: 1 mg oral dose
15974638|NCT03077607|Drug|Itraconazole|100 mg oral dose
15974639|NCT03077607|Drug|Rifampin|600 mg oral dose
15974640|NCT03077594|Device|Mucosal Impedance|Aim 1: Mucosal impedance will be measured by an endoscopic probe 1 cm above the gastroesophageal junction, 5 cm above the gastroesophageal junction and in the proximal esophagus in an area not exposed to the index therapeutic radiofrequency ablation. Aim 2: Mucosal impedance will be measured 1 cm above gastroesophageal junction, 1 cm below previous squamous columnar junction, 1 cm above previous squamocolumnar junction.
15974641|NCT03077594|Other|Research Biopsies|Aim 1: Research biopsies will be obtained at 1 cm above the gastroesophageal junction, 5 cm above the gastroesophageal junction, and in the proximal esophagus in an area not exposed to the index therapeutic radiofrequency ablation. Aim 2: Aim 2: Research biopsies will be taken 1 cm above gastroesophageal junction, 1 cm below previous squamous columnar junction, 1 cm above previous squamocolumnar junction.
15974642|NCT03077594|Device|Volumetric Laser Endomicroscopy|Aim 2: Volumetric laser endomicroscopy will be done and marked at 1 cm above gastroesophageal junction, 1 cm below previous squamous columnar junction, 1 cm above previous squamocolumnar junction.
15974643|NCT03077581|Drug|Transevrsus abdominus plane block|a blunt needle was advanced in the midaxillary line to reach the fascial layer between the internal oblique and transverse abdominis muscles detected by facial click sensation. The LA was slowly injected so as to detect any sign of toxicity or incorrect needle tip position (as resistance) requiring needle repositioning then TAPB was repeated on the opposite side.
15974644|NCT03077581|Drug|Rectus sheath block|In RSB group, 2-3 cm from midline, about 3-5 cm above the umbilicus, the needle was advanced at right angle to the skin. The needle reaches the space between the posterior layer of the rectus sheath and rectus abdominis muscle detected by firm resistance of the posterior wall, The LA was slowly injected then the same steps were repeated on the other side.
15974645|NCT03077581|Drug|local anesthesia infiltartion|40 mls of 0.255 bupivacaine will be infiltrated at skin incision
15974646|NCT03077568|Behavioral|My Stress Control|"The web-based program is designed to educate the users in how stress can affect their health, provide tools to handle stress and also educate the users in a problem-solving method to prevent and manage stress-related problems in the future.
~The program is tailored for each user. The stress-management techniques included are: assertiveness training, change negative thinking, pleasant activity scheduling, relaxation, time-management, stimulus control and sleep restriction to improve sleep and physical activity.
~Central techniques to support behaivor change in My Stress Controll are encourage intention formulation, specific goal-setting, feedback on performance and reevaluation of goals."
15974647|NCT03077555|Drug|Zoely|quick start of combined hormonal contraception containing 1.5 mg estradiol /2.5 mg nomegestrol acetate
15974648|NCT03077555|Drug|Meliane ED|quick start of combined hormonal contraception containing 20 mcg ethinyl estradiol /75 mcg gestodene
15974649|NCT03077542|Procedure|haploidentical stem cell transplant|haploidentical stem cell transplant
15974650|NCT03077542|Drug|sirolimus|conditioning regimen
15974651|NCT03077542|Drug|campath|conditioning regimen
15974652|NCT03077542|Drug|pentostatin|conditioning regimen
15974653|NCT03077542|Drug|cyclophosphamide|conditioning regimen
15974654|NCT03077542|Drug|Hydroxyurea|conditioning regimen
15974655|NCT03077529|Dietary Supplement|Galacto-oligosacchride|During this period subjects will receive 5.65 grams of Vivinal GOS supplements three times daily for four weeks
15974656|NCT03077529|Dietary Supplement|Maltodextrin|During this period subjects will receive 7.24 grams of maltodextrin supplements three times daily for four weeks
15974657|NCT03077516|Device|Mobi-C|Device for cervical intervertebral disc replacement at one or two contiguous levels
15975121|NCT03073785|Radiation|Stereotactic Body Radiation Therapy|Undergo hypofractionated stereotactic radiotherapy
15974658|NCT03077503|Drug|Dexmedetomidine|Dexmedetomidine 1 µg/kg diluted to 20 ml with 0.9% normal saline was administration. If adverse events were occurred, the patient will receive rescue drugs.
15974659|NCT03077503|Drug|Fentanyl|Fentanyl 1 µg/kg diluted to 2 ml with 0.9% normal saline was administration. If adverse events were occurred, the patient will receive rescue drugs.
15974660|NCT03077503|Drug|0.9% normal saline|0.9% normal saline was use to dilute the study drugs
15974661|NCT03077503|Device|Skull pins|Skull pins were use to stabilized the patent' s head during surgery
15974662|NCT03077490|Device|Transvaginal mesh Uphold TM Vaginal Support System|
15974663|NCT03077490|Device|Transvaginal mesh Uphold TM Vaginal Support System.|
15974664|NCT03077477|Drug|AMXT 1501|Study treatment will be provided in tablet form; each containing 128 mg AMXT 1501 dicaprate salt, 80 mg of which is AMXT 1501 freebase (active drug), plus excipients and are orally administered.
15974665|NCT03077477|Drug|Placebo Oral Tablet|"Reference Therapy, Dose and Route of Administration:
~Placebo Tablets, orally administered"
15974666|NCT03077464|Behavioral|Behavioral nutrition education|Education aimed at improving knowledge, attitudes, and practices related to dietary intake, with a focus on impacting theorized mediators of nutrition-related behavior.
15974667|NCT03077451|Other|Laboratory Biomarker Analysis|Correlative studies
15974668|NCT03077451|Drug|Nelfinavir Mesylate|Given PO
15974669|NCT03077438|Biological|Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate|0.5 milliliter (mL), Intramuscular
15974670|NCT03077438|Biological|Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine|0.5 mL, Intramuscular
15974671|NCT03077425|Behavioral|Enhanced Usual Care (EUC)|Per Arm/Group Description, CHWs will provide a pamphlet and dental referral list to participants both groups.
15974672|NCT03077425|Behavioral|Intervention|Per Arm/Group Description, CHWs will a) conduct 6 home visits with mothers/families over a 12 month period along with follow-up phone support, and b) patient navigation support for child to receive 2 dental visits: one by 12 months of age and one by 18 months of age.
15974673|NCT03077412|Drug|Filgotinib|Tablet(s) administered orally once daily
15974674|NCT03077412|Drug|Placebo to match filgotinib|Tablet(s) administered orally once daily
15974675|NCT03077399|Device|SCALA|All items of SCALA are applied
15974676|NCT03077386|Behavioral|ENCOMPASS Intervention|Patients will be matched to a CHN who will conduct a needs assessment to determine the frequency of meetings. A CHN may perform any of the following: providing information to a patient's health care provider, translation, advocating for the patient, connecting the patient with resources (i.e., social, financial, insurance), helping patients set health related goals, liaising with a patient's employer, facilitating health care referrals and appointments, monitoring appointments, and facilitating transportation to appointments. These activities may require the CHN to be physically present at appointments or have direct contact with the patient's health care provider. Goal setting and support will be provided in person or over the telephone using motivational interviewing principles
15974677|NCT03077373|Behavioral|Counseling letter|"The brief counseling letter intervention aiming to reduce physical inactivity, sedentary time in leisure time as well as smoking is based on behavior change theories (Transtheoretical model of health behavior change and Health Action Process Approach).
~The computerized intervention system includes up to six interactions with participants. Recurrent assessments are initiated by the system and provide data for scheduling the proceeding intervention steps and selection of relevant content. Physical activity, sedentary time, smoking, and motivational measures to change or maintain behaviors according to the recommendations will be monitored over time and used to provide feedback in the form of letters."
15974678|NCT03077360|Behavioral|Lifestyle|Lifestyle changes to lose weight or become more fit
15974679|NCT03077347|Device|Transcranial Direct Current Stimulation|In tDCS, saline-soaked electrodes are temporary affixed to the scalp and connected to a battery-powered current generator. A weak (2 mA) constant current is then briefly applied (~20 minutes) to stimulate the targeted brain area (e.g. the DLPFC). To control for placebo effects, the study will utilize a sham stimulation protocol that consists of very brief constant stimulation (~1 minute). Subjects usually cannot discern the difference between the sham and experimental stimulation protocols due to habituation.
15974680|NCT03077334|Device|PET-CT|PET-CT will be done before operation and that is routine treatment procedure for pancreatic cancer.
15974681|NCT03077321|Behavioral|CARE plus Peer Mentor|A parent who has completed the standard CARE program will be recruited to be a peer mentor. The peer mentor will attend the CARE training for group leaders and will also be trained in motivational interviewing. These skills will then be used strategically in weekly phone discussions between the peer mentor and parent about practicing the CARE parenting skills in the home setting and planning for attending the 6 training sessions. The parent mentor will co-facilitate the CARE groups in the peer mentor arm along with 2 additional CARE therapists. The peer mentor will also call the parents in the peer mentor arm before each session to discuss progress on homework, and to address barriers for program attendance.
15974682|NCT03077321|Behavioral|CARE|CARE involves 6 weekly 90-minute sessions administered to 6-10 parents by 2 therapists. The initial phase focuses on developing parenting skills aimed at increasing attention to children's pro-social behaviors while ignoring minor attention seeking misbehaviors. The second phase teaches techniques for giving children effective commands in order to set age-appropriate limits and increase compliance. Children do not attend the training but parents are expected to practice the skills with their children between sessions.
15974683|NCT03077308|Procedure|Auditory and Visual Event-related Potentials and EEG|Specifically, through up to three standardized sessions (i.e., annual [every 10-14 months]), we will assess AEP and VEP. ERP recordings will also provide data for specific rhythms/band (gamma and alpha) pattern analyses as secondary measures as well as technical control data, which will help to exclude those with co-current seizures.
15974684|NCT03077295|Other|High Fibre|High fibre/carbohydrate (50% CHO, 35% fat and 15% Protein) with 45% calories at breakfast and 20% evening meal provided and buffet lunch. Total dietary fibre will be at least 30g/d for 2000kcal intake and provided as a mixed soluble and insoluble fibre sources to maintain palatability of the diet (e.g. wheat bran, fava bean, lentil, buckwheat).
15974769|NCT03076528|Other|Non-technology foot and ankle exercise program|Subjects are asked to perform non-technology based foot and ankle exercises, which include plantar flexion and extension.
15975122|NCT03073785|Drug|Zoledronic Acid|Given IV
15974685|NCT03077295|Other|High Protein|• High protein diet (30% protein, 35% fat and 35% CHO) with 45% calories at breakfast and 20% evening meal provided and buffet lunch. Protein will be a mixed meat matrix to include poultry, fish, red meat, prawns, eggs, dairy. Total dietary fibre will be no more than 15g/d for 2000kcal intake.
15974686|NCT03077282|Drug|Prasaprohyai|Prasaprohyai 95% ethanolic extract capsules will take three times a day before meals
15974687|NCT03077256|Device|BioBurst Fluid, Burst Allograft|BioBurst Fluid, Burst Allograft in Foot and Ankle Surgery
15974688|NCT03077243|Radiation|Intensity Modulated Radiotherapy (IMRT) - deintensified|60 Gy at 2 Gy/fx
15974689|NCT03077243|Radiation|Intensity Modulated Radiotherapy (IMRT) - standard|70 Gy at 2 Gy/fx
15974690|NCT03077243|Drug|Cisplatin (or alternative) - deintensified|The acceptable weekly chemotherapy regimens are Cisplatin 30 to 40 mg/m2 (first choice), Cetuximab 250mg/m2 (second choice), Carboplatin AUC 1.5 and paclitaxel 45 mg/m2 (third choice), Carboplatin AUC 3 (fourth choice). Chemotherapy will be given intravenously weekly during IMRT, 6 total doses.
15974691|NCT03077243|Drug|Cisplatin (or alternative) - standard|The acceptable weekly chemotherapy regimens are Cisplatin 30 to 40 mg/m2 (first choice), Cetuximab 250mg/m2 (second choice), Carboplatin AUC 1.5 and paclitaxel 45 mg/m2 (third choice), Carboplatin AUC 3 (fourth choice). Chemotherapy will be given intravenously weekly during IMRT, 7 total doses.
15974692|NCT03077243|Procedure|Assessment for surgical evaluation|Decision for surgical evaluation will be based on the results of the PET/CT and clinical exam 10-16 weeks after CRT. Patients with a positive PET/CT scan will undergo surgical evaluation at the discretion of the surgeon. Patients with a negative PET/CT scan will be observed.
15974693|NCT03077230|Behavioral|Pre/Post Test of a Lung Cancer Screening Decision Aid|After completing the baseline survey, the research team member will ask each participant asked to view the lung cancer screening decision aid on a tablet. The following areas regarding lung cancer screening: What is lung cancer?, Why is lung cancer a problem?, What is screening?, What is low-dose CT screening, Recommended frequency of screening, Screening factors, lung cancer risks and benefits (magnitude of benefit, harms, false positive, invasive procedures, radiation, stress/anxiety), Summary, Values Clarification, Screening Choice, and Smoking cessation messaging for current smokers OR positive reinforcement for former smokers.
15974694|NCT03077217|Drug|Rifaximin|The investigators use low-dose rifaximin for the treatment of patients with covert hepatic encephalopathy
15974695|NCT03077204|Biological|1 or 2-Level ACDF utilizing BIO4 with Bio AVS Cervical Allograft (with graft window).|The study will utilize the BIO4 on label as a 361 HCT/P (human cell, tissue and cellular and tissue-based product) for homologous use for the repair, replacement or reconstruction of bone defects. Interbody fusion (1 or 2-level fusion) in conjunction with an allograft (hct/p) interbody spacer (anterior approach in the cervical spine with hardware). Investigators will also use the Aviator Anterior Cervical Plating System for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Aviator Anterior Cervical Plating System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Aviator plates are intended to be used with the Aviator bone screws.
15974696|NCT03077204|Device|Aviator Anterior Cervical Plating System|The study will utilize the BIO4 on label as a 361 HCT/P (human cell, tissue and cellular and tissue-based product) for homologous use for the repair, replacement or reconstruction of bone defects. Interbody fusion (1 or 2-level fusion) in conjunction with an allograft (hct/p) interbody spacer (anterior approach in the cervical spine with hardware). Investigators will also use the Aviator Anterior Cervical Plating System for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The Aviator Anterior Cervical Plating System is intended for use as an aid in cervical spinal fusion and is intended for unilateral fixation. The Aviator plates are intended to be used with the Aviator bone screws.
15974697|NCT03077191|Other|Quality of life measurement|The quality of life of breast cancer patients treated with conservative surgery and adjuvant whole breast hypofractionated radiotherapy, without boost, will be evaluated.
15974698|NCT03077178|Procedure|Geriatric assessment|Geriatric assessment, questionnaire assessment
15974699|NCT03077165|Drug|S42909 100 mg|50 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.
15974700|NCT03077165|Drug|S42909 200 mg|50 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.
15974701|NCT03077165|Drug|S42909 400 mg|200 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.
15974702|NCT03077165|Drug|S42909 800 mg|200 mg Film-coated tablets per os administration,twice a day taken at the end of the morning and at evening meals.
15974703|NCT03077165|Drug|S42909 1200 mg|200 mg Film-coated tablets per os administration, twice a day taken at the end of the morning and at evening meals.
15974704|NCT03077165|Drug|Placebo Oral Tablet|Matching placebo tablets, per os administration, twice a day taken at the end of the morning and at evening meals.
15974705|NCT03077139|Device|Cardiac Resynchronization Therapy (CRT)|A CRT device sends small electrical impulses to both lower chambers of the heart to help them beat together in a more synchronized pattern.
15974706|NCT03077126|Other|Fleet Enema|Since a probe will be introduced into the participant's rectal area, participants will be instructed to give themself one regular Fleet enema.
15974707|NCT03077126|Device|Aixplorer® ShearWave Elastography (SWE™)|Pre-surgery ultrasound: Aixplorer® ShearWave Elastography (SWE™) Ultrasound System (made by SuperSonic Imagine, Inc.). The device is used transrectally. This device (ultrasound system) has been cleared by the United States Food and Drug Administration (FDA) for the indication for use as described in this consent form.
15974708|NCT03077126|Diagnostic Test|Pre-surgery Ultrasound|The ultrasound procedure referenced above will be performed at the participant's pre-op visit one to two weeks before their surgery.
15974709|NCT03077126|Procedure|Prostatectomy|Participants will undergo radical prostatectomy as currently performed at our Moffitt Cancer Center. This procedure is performed under general anesthesia in the operating room. This is considered standard of care.
15974710|NCT03077113|Diagnostic Test|4-D CT Scan|The 4-D CT scan shows how the tumor moves when patients breathe so that motion can be taken into account when planning the radiation. This is the usual way of planning lung radiation and everyone in this study will be planned using a 4-D CT scan.
15974770|NCT03076515|Device|Nerivio Migra neurostimulation|transcutaneous electrical stimulation
15974771|NCT03076515|Device|Sham Nerivio Migra|electrical stimulation- shame mode
15974711|NCT03077113|Diagnostic Test|SPECT-CT Scan|It may be possible to make a more accurate plan by using a SPECT-CT scan for planning that would result in less damage to healthy lung tissue. This is not yet proven. A SPECT-CT scan uses a special camera to detect radioactivity to produce pictures which can lead to more precise information.
15974712|NCT03077100|Other|Laboratory identification of positive cultures|Laboratory identification of positive cultures
15974713|NCT03077087|Device|thin Integra® (125 cm2)|125 cm2 represents approximately 0.7% of an average sized patient's total body surface area. The remaining injury areas would be covered with standard-thickness Integra® only. The donor graft, a 4 cm x 10 cm sheet of skin, would be meshed in a 3:1 ratio to be expanded to cover the 125 cm2 sheet of thin Integra®. The patient's post-operative care would be largely unchanged, although the patient would have a donor site of 40 cm2 that would be dressed and managed in the usual fashion.
15974714|NCT03077074|Other|low carbohydrate consumption|consumption of up to 60 grams of carbohydrate a day for 10 days FMRI will be performed prior and after the intervention during the luteal cycle phase
15974715|NCT03077061|Procedure|Open flap debridement|Open flap debridement using saline as irrigation
15974716|NCT03077061|Device|Bone replacement graft|Open flap debridement using saline as irrigation including a grafting procedure withBio-Oss Collagen®.
15974717|NCT03077048|Drug|Ketosteril®|Patients will be randomised to receive isonitrogenous and isocaloric LPD providing 0.6 g protein/kg BW/day and an energy intake of 30-35 kcal/kg BW/day with (test group) or without (control group) intake of Ketosteril® (1 tablet/5 kg BW/day). The control group will get additional food protein to balance the nitrogen content of Ketosteril® The mainly vegetarian diet will be maintained for 10 days.
15974718|NCT03077035|Other|glass ionomer sealants|
15974719|NCT03077035|Other|resin-based sealant|
15974720|NCT03077009|Drug|Hyaluronic Acid|Ultrasound guided injection for plantaris friction syndrome
15974721|NCT03076996|Behavioral|Online support group|"Participants will be enrolled to form five groups of 8 to 10 participants, and then participants will participate in the 6 sessions of the structured educational and group counseling curriculum through the online platform.
~The m/eHealth intervention components include:
~Informational messages that reflect the content of the structured group counseling curriculum, Positive Connections, and are posted to the group wall on a regular basis
~Moderated, closed group chats where ALHIV can interact with their peers and with a trained health counselor on a biweekly basis
~Access to a trained counselor via Facebook Messenger (during normal business hours) for the duration of the intervention who will be able to provide information or basic counseling on ART/HIV care related issues, with referral to health care services as needed"
15974722|NCT03076983|Device|Lung Monitoring with EIT device (PulmoVista 500)|"Patient's lungs will be monitored during clinical routine interventions with Dräger's EIT device (PulmoVista 500).
~No medical interventions to routine patient care required."
15974723|NCT03076970|Drug|lasmiditan 200 mg|drug including single placebo tablet
15974724|NCT03076970|Drug|Sumatriptan|drug including single placebo tablet
15974725|NCT03076970|Drug|matching placebo|single oral tablet -given with single lasmiditan tablet and with single sumatriptan tablet.
15974726|NCT03076957|Drug|CKD-516 Tablet|CKD-516 PO for 5 consecutive days and 2 days off in Combination with Irinotecan inj.
15974727|NCT03076944|Drug|UltraEZ|Prophylaxis, apply uniformly on the teeth, wait 15 minutes, remove the gel from the teeth with cotton and abundant water.
15974728|NCT03076944|Drug|Enamelast|Prophylaxis; dry the teeth; apply uniformly on the teeth with a thin layer.
15974729|NCT03076931|Procedure|Microlaryngoscopy|Standard clinical procedure, used to perform airway sizing and vocal fold calibration. Controls receive one as a research procedure, while study patients receive one as part of standard of care.
15974730|NCT03076931|Procedure|Voice Evaluation|Standard clinical procedure that includes aerodynamic, acoustic, and perceptual voice assessments, a pediatric voice handicap index questionnaire, videostroboscopy, and high-speed videoendoscopy. Controls will receive one as a research procedure, while study patients will receive three, one before their airway reconstruction, and two more in the year afterward, as part of standard of care.
15974731|NCT03076931|Procedure|Airway Reconstruction|This includes many types of invasive surgical procedures such as Laryngotracheoplasty to repair a patient's compromised airway. Only study patients will be receiving one, and it will be as part of standard of care unrelated to this study, but the data from surgery and outcomes being pertinent to the study.
15974732|NCT03076918|Device|FLEXITHERALIGHT PDT|Preparation of lesions, MAL application+occlusive dressing during 30 minutes+illumination 2.5 hours
15974733|NCT03076918|Device|Aktilite® Galderma|Preparation of lesions, MAL application+occlusive dressing during 3 hours+illumination 7 to 10 minutes
15974734|NCT03076905|Drug|F901318|Evaluation of AUC0-t
15974735|NCT03076892|Device|Aktilite® Galderma|preparation of the lesions, Metvixia application + occlusive dressing during 3 hours + illumination: 7 to 10 minutes
15974736|NCT03076892|Device|PHOS ISTOS PDT|preparation of the lesions, Metvixia application + occlusive dressing during 30 minutes + illumination: 2.5 hours
15974737|NCT03076879|Behavioral|Promoting participation in cervical cancer screening|"Nursing education: Women in the experimental group will be trained three times in total, one for the cervical cancer screening and the other two for the individual.
~Reminders by phone; Short messages and calls will be reminiscent of women's participation in cervical cancer screenings.
~Home visit; The content of the training is the key to cervical cancer and screening. After the group training, it is aimed to be an interactive education and counseling service in the form of question-answer method which is not understood by home visiting method.
~Brochure; The brochure for cervical cancer and screening will be given after group training."
15974738|NCT03076866|Other|observational follow-up:clinical, radiological et biological|
15974739|NCT03076853|Other|Opening of the Pharmaceutical Record|After a first prescription without the pharmaceutical record, the study investigator has to open the pharmaceutical record to obtain some additional data. After, he has to choose between maintain or modify his first prescription.
15974740|NCT03076840|Other|Kinesio tape|Kinesio Taping is another option for the treatment of poor hamstring extensibility, It was developed by Kenzo Kase in 1970 and gained a wide popularity by the elite athletes during the various championships and Olympic Games
15974741|NCT03076827|Procedure|Total hip replacement|Total hip replacement starts in the morning in group A and starts in the afternoon in group P.
15974881|NCT03075514|Other|MCT|Medium chain triglyceride ketogenic diet
15974743|NCT03076801|Behavioral|Choral Singing|In addition to usual medical care, participants in the intervention group will participate in weekly 60-90 minute singing sessions led by professional musicians over a 12-week period. Sessions will begin with a 5-minute physical warm-up of gentle stretching and a 5-minute vocal warm-up. Music will be selected from a variety of genres and eras. Attendance will be taken weekly.
15974744|NCT03076788|Other|electrocardiogram and echocardiography|"We retrieved all electrocardiograms and echocardiography made during the clinical examination of each athlete and each sedentary control.
~Standard 12 lead ECG
~Trans-thoracic echocardiography examination of cardiac function, morphology and intracardiac flow."
15974745|NCT03076775|Other|Maternal glycemic control|Maternal capillary blood glucose testing will be performed according to oral intake status: every 2 hours if not eating (NPO) or fasting and 1-hour postprandial if eating regular meals. Hyperglycemia, defined based on the American Diabetes Association and the American College of Obstetricians and Gynecologists recommendations as well as current practice at study sites, will be treated according to study guidelines based on oral intake status: insulin infusion if NPO and subcutaneous insulin if eating regular meals.
15974746|NCT03076762|Drug|intravesical onabotulinumtoxinA injection|Each vial of onabotulinumtoxinA will be diluted with 10 ml of normal saline, resulting in 10U onabotulinumtoxinA per 1.0 ml. Patients assigned for suburothelial BoNT-A injections received 20 injections in the bladder body whereas those assigned trigonal injections will receive 10 sites injections at the trigonal area (5 injections behind interureteric ridge and 5 inside the trigone).
15974747|NCT03076749|Other|Creating models for the diagnosis of BL allergy|
15974748|NCT03076736|Behavioral|Singing group + resource pack|SPA is a community-based, 10 weekly singing group. Each SPA session comprises 30 minutes of settling in/wrap-up and departure, and 60 minutes of group singing. Sessions will be led by a community music leader, co-facilitated by a person with aphasia, and involve the group singing from a songbook. Musical accompaniment will be provided by the facilitator(s). Small percussion instruments will be available for participants, enabling involvement of those with limited singing ability. Intervention content integrates the Information-Motivation-Behavioural (IMB) skills model of health behaviour change to support individuals in developing the social skills and confidence needed to improve psychosocial outcomes. Participants will also receive the resource pack.
15974749|NCT03076736|Behavioral|Resource pack|Resource pack with information on living with aphasia and local community activities.
15974750|NCT03076723|Other|Change in shunt opening pressure|An individually determined change in shunt opening pressure is compared to no change in opening pressure.
15974751|NCT03076723|Other|Simulated change in shunt opening pressure|The shunt opening pressure is reset to the same setting.
15974752|NCT03076710|Drug|Opioids delivered through PCA|IV up to 1 mg. morphine every 10 minutes on request and oral opioids up to 2 tablets of Percocet every 4 hours
15974753|NCT03076710|Drug|EXPAREL® infiltration|"22 gauge / 3.5 needle, into dermal/fascial/muscular/subcutaneous layers and up to 4mg IV morphine every 60 minutes on request and standardized oral opioids on request"
15974754|NCT03076697|Diagnostic Test|Fundus photography|Fundus photographs will be taken with our smartphone-based camera along with the standard of care, including traditional desktop fundus photography. We will test the feasibility and accuracy of a smartphone-based camera for diagnosing disease along with the stage of disease. Several ophthalmologists will grade the smartphone fundus photographs, the traditional retinal photographs, and the documented eye examination. We will assess the agreement between the graders for the diagnosis of eye disease. We will also assess the sensitivity and specificity of diagnoses with the smartphone, using traditional retinal imaging as the reference standard and in a separate analysis using the ophthalmologist's examination as the reference standard.
15974755|NCT03076684|Other|low-fructose diet|Subjects will consume a four-month diet with the goal of reducing added sugar intake from ≥13% of energy to <5% of energy and keeping their weight stable.
15974756|NCT03076684|Drug|Allopurinol|Subjects in the drug arm will take the drug allopurinol daily.
15974757|NCT03076671|Behavioral|Palliative Care|Palliative care training for community neurologists and use of telemedicine for team-based support of patients
15974758|NCT03076658|Radiation|EOS imaging|The EOS imaging system will be utilized to obtain full-body radiographs in frontal and sagittal projections obtained in the upright standing position. Measurements will include a coronal plumb-line, sagittal vertebral axis (SVA), external auditory meatus plumb-line, cervical lordosis, thoracic kyphosis, lumbar lordosis, hip flexion/extension, knee flexion/extension, ankle flexion/extension, T1 tilt, T1 spino-pelvic instance, acetabular index, pelvic tilt (PT), pelvic incidence (PI), and sacral slope (SS).
15974759|NCT03076645|Behavioral|Facilitator support and education|Group engaged with facilitator support and education
15974760|NCT03076632|Device|Cervical plus transcranial stimulation|Conditioning pulses of cervical electrical stimulation will be delivered before or after test pulses of transcranial magnetic stimulation.
15974761|NCT03076632|Device|Cervical stimulation plus hand/wrist exercise|Pulses of cervical stimulation will be delivered while the subject performs finger and wrist motor tasks.
15974762|NCT03076632|Device|Electromyographic (EMG)-triggered (closed-loop) stimulation|Force and EMG activity of specific hand muscles will be used to trigger peripheral nerve electrical stimulation or transcranial magnetic stimulation.
15974763|NCT03076619|Other|clinical ophthalmoscopy|To study the role of clinical ophthalmoscopy in PIH in diagnosis, prognosis, differential diagnosis, line of treatment and effect of treatment.
15974764|NCT03076606|Diagnostic Test|ophthalmologist examination|ophthalmologist examination after geriatric consultation
15974765|NCT03076593|Other|Exposure: Fall|Participants will be asked about prior falls
15974767|NCT03076541|Device|standard 24-h ambulatory polysomnography|A standard 24-h ambulatory ad libitum polysomnography including EEG, electro-oculography (EOG), electromyography (EMG), EKG, was performed by a standard clinical.
15974768|NCT03076528|Other|Sensor-based interactive exercise (game-based exercise)|This intervention includes interactive game-based lower extremity training including repetitive ankle movements in multiple directions. Wearable sensors will provide real-time feedback from foot and ankle position and allow perception of motor-errors during each motor-action
15974882|NCT03075501|Behavioral|Paired|Drug conditioning is assessed by pairing drug administration with a given context.
15974772|NCT03076489|Other|First Visit|blood sample , morpho-anatomic measures (height, weight, hip and size), impedancemetry and resting energy expenditure by indirect calorimetry, sample of urine and faeces previously collected at home
15974773|NCT03076489|Other|on-line questionnaires|The two on-line questionnaires (hedonic and caloric evaluation of foods and beverages on photos) will have to be completed by the volunteers between the first and the second visit to the University-Hospital.
15974774|NCT03076489|Device|fMRI|a cognitive two-choice test based on food and drink pictures, during fMRI. Before and after the fMRI session, an assessment of the state of hunger, thirst, and general status of the volunteer will be carried out using a numerical scale ranging from 1 to 10.
15974775|NCT03076476|Device|Bioresorbable Vascular Scaffolds (BVS)|Bioresorbable Vascular Scaffold. Introduced after the interim analysis (phase 2) for comparison with DES-slow.
15974776|NCT03076476|Device|Drug-Eluting Stent (DES) - slow|"Slow device inflation (mandated in the BVS IFU). To be compared with the DES-std group at interim analysis at the end of phase 1 stage.
~After the interim analysis DES-slow to be compared with BVS."
15974777|NCT03076476|Device|Drug-Eluting Stent (DES) - standard(std)|Metallic DES implanted in standard fashion. To be compared with the DES-slow group at interim analysis at the end of phase 1 stage.
15974778|NCT03076463|Dietary Supplement|GRAPOM|The whole intervention will be divided in 2 periods, control (CTR) and dried and milled grape pomace (GRAPOM). The two periods will have a duration of 6 weeks. During the CTR period, subjects will follow their normal dietary habits and samples will be collected at the beginning and at the end. No proper placebo could be found for the product, so this CTR period was chosen. During the GRAPOM period, the subjects will daily consume 8 g of the product solved in water and samples will be collected at the beginning and at the end.
15974779|NCT03076450|Device|Lung Ultrasound|Adjust PEEP real-time in term of LUS-RAS chang.
15974780|NCT03076450|Diagnostic Test|Maximum Oxygenation|Adjust PEEP real-time in term of PaO2+PaCO2≥400mmHg whether or not.
15974781|NCT03076437|Combination Product|Drugs and Anti-CD19-CAR transduced T cells|"Drug: Fludarabine On days -4 through -2, Fludarabine 30mg/m2 IV will be infused over 30 minutes. Drug: Cyclophosphamide On days -4 through -2, Cyclophosphamide 300mg/m2 IV will be infused over 60 minutes followed by fludarabine.
~Biological: Anti-CD19-CAR transduced T cells Modified cells will be infused IV over 30 minutes (1-3 days after the last dose of fludarabine)."
15974782|NCT03076424|Other|no intervention used|Patients will be giving a blood sample after 8 hours of fasting.
15974783|NCT03076411|Drug|Pepsin|
15974784|NCT03076385|Biological|VAL-506440|Escalating dose levels
15974785|NCT03076385|Other|Placebo|
15974786|NCT03076372|Drug|MM-310|MM-310
15974787|NCT03076359|Behavioral|Traditional Healer Support Program|"Traditional Healers will provide the traditional healer support program assistance, as previously described, to all newly diagnosed patients."
15974788|NCT03076359|Drug|Standard of Care|First-line ART will consist of two nucleoside reverse-transcriptase inhibitors (NRTIs) plus a non-nucleoside reverse-transcriptase inhibitor (NNRTI)- TDF + 3TC (or FTC) + EFV as a fixed-dose combination to be taken twice a day for the rest of the patient's life), clinic-based counseling, and community searches if lost to follow up.
15974789|NCT03076333|Diagnostic Test|PET/MR|Patient will be scheduled for a pre-treatment PET/MR and proceed to neoadjuvant radiation therapy per the direction of the radiation oncologist. At the end of the second week of radiation therapy the patient will undergo a mid-treatment PET/MR. The patient will the complete their radiation therapy. Four weeks after radiation therapy the patient will undergo a post-treatment PET/MR, and proceed for curative intent surgery at 6-8 weeks post radiation if they are still surgical candidates.
15974790|NCT03076320|Combination Product|PDF+M-DDO|Participants with moderate and severe acne will be treated two times a day on the face and superior back with a smooth layer (standard finger tip unit 0.5 g for an area of 100 to 120 square centimeters) of Zaxcell (Pirfenidone with M-DDO) in form of a gel. Patients have to wait 20 min without cover those sites.
15974791|NCT03076320|Combination Product|A+PBO|Participants with moderate and severe acne will be treated once a day (at night) on the face and superior back with a smooth layer (standard finger tip unit 0.5 g for an area of 100 to 120 square centimeters) of Effezel (Adapalene with benzoyl peroxide) in form of a gel. Patients have to wait 20 min without cover those sites
15974792|NCT03076307|Behavioral|Procedural Motor Skills with mirror-drawing of figures|Evaluation of error rate and speed for completion of a procedural motor task
15974793|NCT03076294|Device|TMS|Repetitive TMS involves application of electric currents in the patient's cortex by a magnetic field applied to the scalp of the patient through an eight-coil connected to a magnetic stimulator (MagStim Rapid² magnetic stimulator-UK). In a small percentage of patients, it may cause minimal discomfort with a mild headache sensation, which usually disappears after a few seconds. Depending on the parameters, rTMS can increase or decrease corticomotor excitability and by the connection of the motor cortex with the thalamus, influencing pain control. The patients will respond to an adverse effects questionnaire and will report the perception of real or sham stimulation.
15974794|NCT03076294|Other|Manual therapy (MT)|This intervention uses manual contact for diagnosis and treatment, its practitioners use an enormous amount of manual techniques to preserve the homeostasis through the recovery of dysfunctions, which may cause limitations in the physiological movements, in the accessory movements of the joints (WHO , 2010).
15974795|NCT03076281|Drug|Metformin Hydrochloride|Given orally
15974796|NCT03076281|Drug|Doxycycline|Given orally
15974797|NCT03076281|Drug|Metformin +Doxycycline|Given orally
15974798|NCT03076268|Behavioral|Treinta Millones de Palabras - Visitas al Hogar|TMP-Visitas al Hogar is a cultural and linguistic adaptation of the TMW-Home Visiting curriculum into Spanish. The 12-module curriculum has been translated into Spanish and adapted to address concerns that are vital to mono- and bilingual Spanish-speaking families, including the broadening research base for when to introduce a second language to a child and the benefits of bilingualism.
15974799|NCT03076255|Procedure|Computed Tomography|Undergo CT simulation
15974800|NCT03076255|Device|Medical Device|Given thermoplastic mask
15974801|NCT03076255|Device|Medical Device|Given MID
15974802|NCT03076255|Procedure|Cone-Beam Computed Tomography|Undergo CBCT imaging
15974803|NCT03076242|Other|GEM Registry|Men with a personal history of PCA; Unaffected males who are at higher risk for prostate cancer
15974883|NCT03075501|Drug|Stimulant or sedative|CS+ for paired, CS0 for unpaired
15974804|NCT03076229|Behavioral|Healthy Marriage Program|Provide the following allowable activities 1) marriage and relationship education/skills, 2) relationship enhancement, 3) premarital education, and 4) divorce reduction.
15974805|NCT03076216|Device|OncoSil™|The implantation of OncoSil™ under EUS
15974806|NCT03076203|Drug|Niraparib|Given orally
15974807|NCT03076203|Radiation|Radium Ra 223 Dichloride|Given intravenously
15974808|NCT03076190|Behavioral|Psychoeducational My Surgical Success Video|The 90-minute video includes instruction by Dr. Beth Darnall, PhD, a pain psychologist at the Stanford Pain Management Center. She teaches the viewer about the relationship between stress, pain, and catastrophizing and provides instruction and skills to reduce catastrophizing, decrease stress, and increase relaxation.
15974809|NCT03076177|Other|Taping application|Kinesio taping application will be applied for experimental group; non specific taping application for control
15974810|NCT03076164|Drug|Trametinib|Trametinib 1.5mg once daily by mouth
15974811|NCT03076164|Drug|Erlotinib|Erlotinib 75mg once daily by mouth
15974812|NCT03076151|Drug|Tacrolimus monohydrate (ADOPORT®)|Pharmacokinetic of Tracrolimus (ADOPORT®) on 9 blood sampling by kinetics on 4 kinetics
15974813|NCT03076138|Device|Gene-activated matrix (OCP + plasmid DNA with VEGF gene)|Bone grafting procedure with investigated medical device
15974814|NCT03076125|Behavioral|SCORRE|3 components based on the Health Belief Model
15974815|NCT03076125|Behavioral|Attention-Control Activity|sexual health education
15974816|NCT03076112|Drug|Ipragliflozin|Ipragliflozin as add-on to Metformin and Sulfonylurea in patients with poorly controlled type 2 diabetes
15974817|NCT03076112|Drug|Sitagliptin|Sitagliptin as add-on to Metformin and Sulfonylurea in patients with poorly controlled type 2 diabetes
15974818|NCT03076099|Drug|Dexmedetomidine|1.2 μg/kg Dexmedetomidine was administered intravenously constantly after tracheal extubation.
15974819|NCT03076099|Other|normal saline|equal volume of normal saline was administered intravenously constantly after tracheal extubation.
15974820|NCT03076086|Other|Induced sputum procedure|induced sputum is a sputum specimen produced for diagnostic tests by aerosol administration of a hypertonic saline solution.
15974821|NCT03076073|Other|Impact of physical activity on tendons|Single vs. multiple (up to 12 weeks) of different types of physical exercises (aerobic vs. anaerobic activities).
15974822|NCT03076060|Behavioral|Ketogenic diet|"Two different kind of diet, a Very Low Calories Ketogenic Diet (KD) and a sham weight-loss diet (SD), will be consecutively administered in each patient recruited in the study for one month. To avoid the bias of different caloric intake, SD group will undergo to a non-ketogenic Very Low Calories Diet . Randomly patients will start with KD or SD.
~Patients assigned to this arm will follow the KD."
15974823|NCT03076060|Behavioral|Sham Diet|"Two different kind of diet, a Very Low Calories Ketogenic Diet (KD) and a sham weight-loss diet (SD), will be consecutively administered in each patient recruited in the study for one month. To avoid the bias of different caloric intake, SD group will undergo to a non-ketogenic Very Low Calories Diet . Randomly patients will start with KD or SD.
~Patients assigned to this arm will follow the SD."
15974824|NCT03076047|Procedure|end-tidal CO2 (ETCO2) monitoring with Smart CapnoLine Plus O2|monitor end tidal CO2 levels while patients recover in post-anesthesia care unit (PACU) using the Smart CapnoLine Plus O2
15974825|NCT03076034|Device|Reference Point Indentation|"The Osteoprobe: Since these first reports of indentation measurements in humans in vivo, a more 'user-friendly' device, the Osteoprobe® has been developed by Active Life Scientific (Santa Barbara, CA) (10). The Osteoprobe®, which we will use in the current study, is smaller than the previous reference point indentation (RPI) instrument and is designed to be used in a hand-held fashion to allow for rapid measurements. The new instrument does not require a reference probe, because the inertia of the instrument keeps it adequately fixed in space during the short time of the indentation impact (~0.25 milliseconds). The main parameter measured is the distance that the probe further indents into the bone from the reference point. Key components of the Osteoprobe® include an impact generation mechanism, a displacement transducer, and a probe made of hardened stainless steel with a 90 degree conical tip, with a tip diameter of ~375 µm."
15974826|NCT03076021|Drug|Isotretinoin|Drug interaction study
15974827|NCT03076021|Drug|dextromethorphan|Drug interaction study
15974828|NCT03076008|Other|Observational|No intervention
15974829|NCT03075995|Other|hight-fat breakfast|It's divided into two stages.For the first stage,the subjects take lapatinib on an empty stomach,the steady state plasa concentration is examined on the 9th and 10th days after lapatinib is administered.The second stage,the subject take lapatinib with hight-fat breakfast,the steady state plasa concentration is examined as the first stage.
15974830|NCT03075956|Drug|5 mg E4 single-dose|A single oral dose of 5 mg E4 will be administered during Period 1 of the study.
15974831|NCT03075956|Drug|15 mg E4 single-dose|A single oral dose of 15 mg E4 will be administered during Period 1 of the study.
15974832|NCT03075956|Drug|45 mg E4 single-dose|A single oral dose of 45 mg E4 will be administered once orally during Period 1 of the study
15974833|NCT03075956|Drug|15 mg E4 multiple-dose|15 mg E4 will be administered once daily orally for 14 consecutive days during Period 2 of the study
15974834|NCT03075943|Dietary Supplement|InSea2|Daily supplement: 2 capsules of InSea2
15974835|NCT03075943|Dietary Supplement|Placebo|Daily supplement: 2 capsules of Placebo
15974836|NCT03075930|Device|Extended Electrocardiogram|ECG with 3 additional leads and a 5 minute recording
15974837|NCT03075930|Device|Body surface potential map|ECG with 184 leads and a 5 minute recording
15974838|NCT03075917|Other|Self Questionnaire|self questionnaire for allergic rhinitis control
15974839|NCT03075904|Drug|ALXN1830|Administered via IV infusion.
15974840|NCT03075891|Drug|Ivermectin 1% cream|Topical to the face, approximately one small pea size amount per facial region (right and left cheeks, forehead, chin, and nose) once a day for 12 weeks
15974841|NCT03075891|Drug|Doxycycline 40 mg MR (30 mg Immediate Release & 10 mg Delayed Release beads) capsules|1 Capsule once-daily for 12 weeks
15974842|NCT03075891|Other|Oral placebo capsules|1 Capsule once-daily for 12 weeks
15974843|NCT03075878|Drug|ALXN1830|Administered via IV infusion.
15974884|NCT03075501|Drug|Placebo|CS- for paired, CS0 for unpaired
15974885|NCT03075488|Device|Accuro|spinal anesthesia injection based on identification of entry site with pre-procedural ultrasound scan with Accuro device
15974844|NCT03075865|Device|OmniMax MMF system|OmniMax MMF system consists of arch bars and screws that work together to achieve temporary fixation of the maxilla and mandible to provide indirect or passive stabilization of fractures and maintenance of occlusion in the oral and maxillofacial region. The arch bars have hooks designed to accommodate either wires or elastic bands for temporary maxillomandibular fixation (MMF) either intraoperative or postoperative.
15974845|NCT03075852|Device|Heads- Up Display Surgery|Patient undergoes VR surgery with visualization using heads up display 3D monitor viewed by the operating surgeon.
15974846|NCT03075839|Other|Cigarette Brand Switching|Adult smokers will be switched from smoking menthol cigarettes to non-menthol cigarettes for a period of two weeks
15974847|NCT03075826|Drug|SGI-110|subcutaneously at a dose of 60 mg/m2
15974848|NCT03075813|Other|Intervention Cluster|Surgical surveillance date will be analyzed by optimized SPC methods. if signal is generated, study personnel in DICON will be notified to adjudicate the signal and determine if further action is needed.
15974849|NCT03075800|Behavioral|Assertive Community Treatment (ACT) + Illness Management and Recovery (IMR)|The integrated ACT+IMR model was developed and manualized prior to the start of this evaluation (27). The model incorporates the following key features: a) ACT staff provide IMR in office-based group and/or individual sessions in office or community settings; b) regular community follow-up by ACT staff to assist clients with practicing IMR skills and achieving their goals; c) regular communication within ACT team (e.g., during daily meetings) on IMR client goals and progress; and d) supervision and consultation on IMR within ACT.
15974850|NCT03075787|Device|standard 24-h ambulatory polysomnography|A standard 24-h ambulatory ad libitum polysomnography including EEG, electro-oculography (EOG), electromyography (EMG), EKG, was performed by a standard clinical.
15974851|NCT03075761|Device|Fitbit|The Fitbit will be utilized in the intervention arm to improve adherence to a 12-week activity regimen.
15974852|NCT03075761|Behavioral|30-minute education session|
15974853|NCT03075748|Device|TAAA Debranching Stent Graft System|The TAAA Debranching Stent Graft System is made up of two main body components and makes use of several off-the-shelf FDA-approved stent graft components. The two custom main body grafts are the thoracic bifurcation and the visceral manifold. The thoracic bifurcation is deployed in the thoracic aorta and provides the proximal seal for the device. The two limbs of the thoracic bifurcation allows for continued aortic flow while deploying the visceral segment. The visceral manifold is deployed within the larger 20 mm limb of the thoracic bifurcation to set the stage for the visceral debranching. The branches of the visceral manifold extend to the visceral vessel with the use of covered bridging stents and provide distal seal of the manifold.
15974854|NCT03075722|Device|Saturn nasal mask|Nasal mask for the treatment of obstructive sleep apnea (OSA)
15974855|NCT03075709|Other|Clinical Pathway (CPW)|CPWs bring the available evidence to a range of healthcare professionals by adapting guidelines to a local context and detailing the essential steps in the assessment and care of patients.
15974856|NCT03075696|Drug|Glofitamab|Glofitamab will be administered at a dose and as per the schedule specified in the respective arms.
15974857|NCT03075696|Drug|Obinutuzumab|Obinutuzumab 1000 mg single dose IV infusion on Day -7; or 2000 mg single dose administered on Day -7, or split into two 1000 mg doses administered on Days -1 and -7, and per the schedule specified in the respective arms.
15974858|NCT03075696|Drug|Tocilizumab|Tocilizumab will be administered as an IV infusion, if required, for the management of severe Cytokine Release Syndrome (CRS) occurring during or after any infusion of glofitamab, as per the methods described in the Summary of Product Characteristics (SmPC) or other similar local prescribing documents.
15974859|NCT03075683|Behavioral|Cognitive behavioural therapy|Eight sessions of internet-based CBT for insomnia comorbid with chronic pain, with active therapist support.
15974860|NCT03075683|Behavioral|Applied relaxation|Eight sessions of internet-based applied relaxation for insomnia comorbid with chronic pain, with active therapist support.
15974861|NCT03075670|Drug|N9-GP|A single dose of 50 IU/kg for intravenous (i.v.) injection
15974862|NCT03075670|Drug|ALPROLIX®|A single dose of 50 IU/kg for intravenous (i.v.) injection
15974863|NCT03075657|Drug|Risperidone|Risperidone will be prescribed at dose of 2 mg per day
15974864|NCT03075657|Drug|Risperidone and Ramelteon|Ramelteon will be prescribed 8mg/day as an add-on therapy to Risperidone 2 mg per day
15974865|NCT03075657|Drug|Haloperidol|Haloperidol will be prescribed at a dose of 4 mg per day
15974866|NCT03075657|Drug|Haloperidol and Ramelteon|Ramelteon will be prescribed 8mg/day as an add-on therapy to Haloperidol 4 mg per day
15974867|NCT03075644|Drug|somapacitan|Once weekly subcutaneous injections (s.c., under the skin)
15974868|NCT03075644|Drug|Norditropin|Daily subcutaneous injections (s.c., under the skin)
15974869|NCT03075631|Other|Questionnaire|Questionnaires
15974870|NCT03075618|Behavioral|Questionnaires|Questionnaires
15974871|NCT03075579|Drug|Medication Other|medication of atomoxetine
15974872|NCT03075579|Device|motor measurement and saliva collection|motor measurement by actometer and saliva collection for measurement of saliva cortisol and saliva alpha amylase
15974873|NCT03075566|Biological|Healthy subjects|- 207 healthy subjects were donors,(33.2±12.2 years) recruited from the Blood Bank Department of the University Hospital (Mahdia, Tunisia).
15974874|NCT03075566|Biological|Patients|- 310 subjects with CAD (60.3±11.0 years) were admitted to the Department of Cardiology, University Hospital (Monastir, Tunisia).
15974875|NCT03075553|Other|Laboratory Biomarker Analysis|Correlative studies
15974876|NCT03075553|Biological|Nivolumab|Given IV
15974877|NCT03075540|Behavioral|Genetic Counseling and Testing YouTube Video|Participants (n=40) will watch a 15-minute YouTube video that will describe the genetic counseling and testing process and risk/benefit information in a telenovela style format. Participants will complete pre- and post-assessments. After the session, participants interested in pursuing genetic counseling and testing services will be referred to the patient navigator at their respective sites, who will navigate participants to identified no cost or low cost services
15974878|NCT03075527|Drug|Tremelimumab|Tremelimumab blocks a receptor on immune cells that normally suppresses immune attack.
15974879|NCT03075527|Drug|Durvalumab|Durvalumab is a drug that blocks a protein often produced by cancer cells or surrounding cells to suppress immune cells from attacking cancer cells.
15974880|NCT03075514|Other|MKD|Modified ketogenic diet
15974886|NCT03075488|Procedure|cutaneous landmarks|spinal anesthesia injection based on identification of entry site with palpation of cutaneous landmarks
15974887|NCT03075475|Behavioral|Common Elements Treatment Approach|The Common Elements Treatment Approach (CETA), is a trans-diagnostic psychotherapy that is based on common evidence-based treatments for depression, anxiety, trauma and stress related disorders. This treatment can be used to treat individuals with any of these mental health problems and with any combination of these problems. CETA expands upon traditional treatment approaches that are designed to focus on one specific disorder and has been proven through multiple rigorous trials to reduce the burden of multiple common mental health problems and improve functionality among men and women living in low resource settings. CETA can be provided to people in their own communities by trained and supervised lay providers, for example community health workers.
15974888|NCT03075462|Drug|Fluzoparib|Fluzoparib either at 40,60,80mg twice daily,capsule oral.
15974889|NCT03075462|Drug|Apatinib|Apatinib at 250mg once daily, tablet oral
15974890|NCT03075436|Behavioral|Enhanced demand-side sanitation, hygiene|The enhanced, demand-side sanitation and hygiene intervention package will be informed by findings from formative research, and will consist of interventions designed to enhance sanitation and hygiene messaging to better facilitate behavior change, and intensify implementation of related community-based interventions via engagement of various delivery modalities.
15974891|NCT03075436|Behavioral|Standard of care|The comparison group will receive the current standard of care, including potential implementation of government-led policies and programs.
15974892|NCT03075423|Drug|Ipilimumab plus nivolumab|Ipilimumab every 3 weeks for 4 times Nivolumab every 3 weeks for 4 times followed by maintenance therapy with nivolumab every 2nd week
15974893|NCT03075423|Drug|Sunitinib|Sunitinib is administered orally 50 mg tablets for 4 weeks on and 2 weeks off
15974894|NCT03075410|Drug|GSK3036656|GSK3036656 is available as capsules (for oral administration) containing 5 mg, 25 mg or 100 mg of GSK3036656 as free base equivalent.
15974895|NCT03075410|Drug|Placebo|Placebo is a matching capsule containing Avicel PH (Suitable for Pharmaceutical Use) 102, for oral administration.
15974896|NCT03075397|Other|blood sample|A sample of HIV-1 infected patients's blood is collected
15974897|NCT03075397|Other|sperm sample|A sample of HIV-1 infected patients's sperm is collected
15974898|NCT03075384|Procedure|computer-assisted navigation system|The computer-assisted navigation system was applied in treatment of unilateral complicated zygomatic fractures
15974899|NCT03075371|Other|Glucose|75 g of glucose dissolved in 300 ml of water
15974900|NCT03075371|Other|Placebo|300 ml of tap water
15974901|NCT03075358|Drug|Lidocaine spray|Patients are locally anesthetized with 8 puffs (80 mg, 10mg/puff, 0.8 ml) of 10% lidocaine spray applied thoroughly to the cervix, 3 minutes before starting the procedure.
15974902|NCT03075358|Other|Normal saline spray|0.8 ml of normal saline spray is applied to the cervix, 3 minutes before starting the procedure
15974903|NCT03075345|Behavioral|Acceptance and commitment therapy|Four sessions of the ACT protocol will be psychoeducational in nature, with brief experiential exercises in the class and in-between session practice. It's aim is to allow individuals to be able to sit with difficult experiences (rather than fight against them) and in turn this may allow them to live towards what they value in life.
15974904|NCT03075345|Behavioral|Treatment as usual (dietetic intervention)|Six sessions of a dietetic intervention will be psychoeducational in nature around weight and nutrition, delivered by professionals working in the service.
15974905|NCT03075332|Other|combined training|Combined training consisting of aerobic and resisted training in the same training session for 15 weeks followed by 5 weeks of detraining
15974906|NCT03075319|Procedure|Received perioperative photograph|"All participants in experimental group were adviced to see periopertive knee photograph before rehabilitation everyday.
~Postoperative knee ROM were recorded at day 3, 6 week, 3 month and 6 month. Flexion and extension angle were measured with long arm goniometer.
~The outcome assessors were blinded to treatment groups."
15974907|NCT03075319|Procedure|Didn't receive perioperative photograph|"All participants in active comparator group didn't receive perioperative knee photograph.
~Postoperative knee ROM were recorded at day 3, 6 week, 3 month and 6 month. Flexion and extension angle were measured with long arm goniometer.
~The outcome assessors were blinded to treatment groups."
15974908|NCT03075306|Behavioral|intervention|the 12-month CHAMPION intervention with a health coach who provides healthy lifestyle counseling and support for weight management, a healthy diet and increased physical activity incorporating techniques to engage both the youth and parents
15974909|NCT03075293|Other|Determination of pain management|Determine of pain management given to children with appendicitis in ER according to their medical records
15974910|NCT03075280|Procedure|400ml high carbohydrate liquid diet before ERCP|400ml high carbohydrate liquid diet uptake 2 hours before ERCP
15974911|NCT03075267|Drug|PT010 (BGF MDI) 320/14.4/9.6 µg|A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8.
15974912|NCT03075267|Drug|PT010 (BGF MDI) 160/14.4/9.6 µg|A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8.
15974913|NCT03075267|Drug|PT003 (GFF MDI) 14.4/9.6 µg|A single dose of study drug will be administered on Day 1 and BID doses will be administered Day 2 through Day 7 of the Treatment Period, with a final single administration of study drug occurring on the morning of Day 8.
15974914|NCT03075254|Device|A Peltier for Sensory testing|Subjects will be trained to rate the magnitude of late sensations elicited following brief (700 msec) contact of a preheated thermode with the glabrous (palmar) skin of either hand/foot either numerically or using a visual analogue scale.
15974915|NCT03075254|Device|functional magnetic resonance imaging for Brain Neuroimaging|to evaluate baseline changes in regional cerebral blood flow to nociceptive thermal stimuli applied to the extremities of FM patients and healthy volunteers.
15975034|NCT03074448|Device|Aquanet|Aquanet bowel cleansing devices
15975035|NCT03074448|Drug|Sodium Picosulfate|Sodium Picosulfate solution (Picoprep)
15975036|NCT03074435|Device|Insecticidal paint|Houses will be painted with insecticidal paint
15975037|NCT03074435|Device|Larvicide|Larval breeding sites will be treated with larvicide
15974916|NCT03075254|Device|fMRI for Spinal Cord Neuroimaging|The subjects will be positioned supine and immobilized by means of a padded head support. The spinous process of the first thoracic vertebra (T1) will be aligned with the center of surface Neuro - coil. This coil will be employed for both transmission of radio-frequency (RF) pulses and detection of the magnetic resonance (MR) signal. A modified FLASH sequence will be employed to obtain Blood Oxygen Level Dependent (BOLD)-sensitive images of the spinal cord.
15974917|NCT03075241|Drug|Zolpidem|Zolpidem tablets, 10mg, 10pm (before bedtime) for 14 nights
15974918|NCT03075241|Drug|Zoplicone|Zoplicone tablets, 7.5mg, 10pm (before bedtime) for 14 nights
15974919|NCT03075241|Drug|Placebo|Inactive or inert pill which will be used as a comparator
15974920|NCT03075228|Device|IntelliCap|Sampling of the small intestine using a samling capsule.
15974921|NCT03075215|Device|Device Programming of the Boston Scientific Cardiac Resynchronization Therapy Defibrillator (CRT-D)|The optimization during the standard of care visits in the first 12 months following implantation
15974922|NCT03075202|Device|e-cigarette, brand name JUUL|This is not an experimental study/trial, rather a prospective observational study. Device will be offered to cohort, but they are not mandated to take or use the device.
15974923|NCT03075189|Dietary Supplement|Whey protein supplement|"During hospitalization the intervention group will receive a whey protein enriched snack/meal in the morning and before bedtime. They will be given 15 gr of protein every morning, and the meal before bedtime will vary in protein content according to the individual needs. Diet registration will be carried out every day during hospitalization. At discharge, participants in the intervention will be instructed and advised with focus on consuming more protein at home.
~The control group are having the ordinary hospital diet and are following normal guidelines. They are not offered the protein focused counseling at discharge.
~Both groups have diet registration and testing at baseline, discharge and follow-up."
15974924|NCT03075176|Device|Wavefront optimized LASIK|Wavefront optimized laser vision correction
15974925|NCT03075176|Device|Wavefront optimized Photorefractive Keratectomy|Wavefront optimized laser vision correction
15974926|NCT03075176|Device|Topography-guided LASIK|Topography-guided laser vision correction
15974927|NCT03075176|Device|Topography-guided Photorefractive Keratectomy|Topography-guided laser vision correction
15974928|NCT03075163|Procedure|Acupressure|"Specifically trained personnel will apply pressure on the wrists bilaterally at the P6 point for up to 3 minutes. The P6 point is located three fingerbreadths from the wrist crease on the volar surface of the arm between the palmaris longus and flexor carpi radialis.
~In the event of failure in the acupressure group, further treatments will be identical to the control group. Since Ondansetron is the standard Post Anesthetic Care Unit treatment, it will be first line rescue therapy except in the case that the patient has received 8mg in the past 6 hours. If needed, further antiemetic pharmacologic treatments may include, but are not limited to, phenergan, metoclopramide, haloperidol, diphenhydramine or propofol at the clinical discretion of the patient's anesthesiology care team."
15974929|NCT03075163|Drug|Ondansetron|Ondansetron is a medication that belongs to the drug class known as antiemetic and selective 5-HT3 receptor antagonist. Ondansetron is prescribed for the treatment of nausea and vomiting due to cancer chemotherapy and also used to prevent and treat nausea and vomiting after surgery.
15974930|NCT03075137|Device|External counter pulsation (ECP)|standard ECP protocol involves 35 one-hour sessions (once per day, 5 days a week) and continuous for 7 weeks. ECP consists of three sets of pneumatic cuffs attached to each of the patient's legs at the calf and lower and upper thigh. The inflation of the cuffs is triggered by a computer, and timing of the inflation is based on the R wave of the electrocardiogram. The ECP therapist adjusts the inflation and deflation timing to provide optimal blood movement per a finger plethysmogram waveform reading.
15974931|NCT03075124|Device|External Counter Pulsation|A standard ECP protocol involves 35 one-hour sessions (once per day, 5 days a week) and continuous for 7 weeks. ECP consists of three sets of pneumatic cuffs attached to each of the patient's legs at the calf and lower and upper thigh. The inflation of the cuffs is triggered by a computer, and timing of the inflation is based on the R wave of the electrocardiogram. The ECP therapist adjusts the inflation and deflation timing to provide optimal blood movement per a finger plethysmogram waveform reading.
15974932|NCT03075111|Diagnostic Test|ImmunoXpert|Host based immune response test distinguishing viral versus bacterial infection
15974933|NCT03075098|Device|Digital colposcope|Diagnostic accuracy of colposcopic examination; Swede scoring system will be used to evaluate the colposcopic examination. Then, the specificity (%) and the sensitivity (%) of colposcopic examination will be calculated using the cutoff value of 8 to segregate dysplastic from non-dysplastic lesions.
15974934|NCT03075085|Behavioral|WISE (We Inspire Smart Eating)|An enhanced implementation strategy for evidence-based obesity prevention in childcare
15974935|NCT03075072|Radiation|Whole brain radiation|Treatment of the whole brain with radiation. When possible the hippocampus will be spared from radiation.
15974936|NCT03075072|Radiation|Stereotactic radiation (SRS)|Focused radiation to each individual brain metastasis without treatment of the remainder of the brain.
15974937|NCT03075059|Behavioral|Child Life|For patients randomized to the intervention group, the Child Life specialist will reach out via telephone to offer support and expertise in helping prepare their child and themselves for outpatient surgery to help decrease anxiety and increase coping. Concepts covered will include: developmentally appropriate language for explaining surgery and related procedures, potential coping skills to ease separation for caregivers and pediatric patients. Additionally, written materials (attached) covering the same information will be sent via mail or email covering the same information discussed in the phone conversation to serve as a refresher and resource before the day of surgery. On the day of surgery, the patient will receive standard of care (SOC) Child Life Services available to all patients.
15974938|NCT03075046|Device|Blue LED 405 nm|It will be applied a 405 nm blue Tonderm LED with a power of 1.66 W / m2, in a closed room by a physiotherapist for 30 minutes. The apparatus shall be supported on a tripod, statically, externally, 5 cm away from the vulva and vagina region, with the patient naked, in gynecological stretcher and lithotomy position. The protocol will consist of only one session.
15974939|NCT03075046|Other|Questionnaire of anamnesis|The participants will answer the anamnesis Questionnaire that will be applied by the physiotherapist
15975038|NCT03074435|Biological|Ivermectin|Doses of Ivermectin will be injected to peri-domestic animals
15975185|NCT03073226|Device|Olympus Elite|New generation Olympus endoscope
15974940|NCT03075033|Device|Shikani optical stylet|Tracheal intubation is performed using Shikani optical stylet. The shikani optical stylet was bent to the same bend as a Mackintosh laryngoscope blade, lubricated and the endotracheal tube was mounted on it. The tube was settled to the stylet by the 'adjustable tube stop' so that the tip of the stylet did not project beyond the end of the tube. After intubation the 'tube stop' was released and the tube was unmounted into the trachea; the stylet was removed.
15974941|NCT03075033|Device|Flexible fiberoptic bronchoscope for|AwakeRracheal intubation using flexible fiberoptic bronchoscope in patients with cervical spine instability
15974942|NCT03075020|Other|Carbon monoxide|carbon monoxide, 4.7, Purity 99.997, inhalation of carbon monoxide in a volume corresponding to carboxyhemoglobin 10 and 20%, calculated from baseline Hg and body mass
15974943|NCT03075020|Other|AIR|Room air will be administered as placebo
15974944|NCT03075007|Radiation|Florbetaben F18|10Meq of Florbetaben F 18 via intravenous injection is to be used. Visit duration is approximately 3 hours.
15974945|NCT03075007|Procedure|Transcranial Doppler|All participants will undergo Doppler ultrasonography that measures the velocity of blood flow through the brain's blood vessels. Visit duration is approximately 45 minutes and will be scheduled for either the same day or another day as the PET scan.
15974946|NCT03074994|Drug|Peri-articular TXA (15 mg/kg)|combined with multimodal local anesthetic infiltration (0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg) mixed NSS up to 75 mL
15974947|NCT03074994|Drug|Intraarticular TXA 2 g (40 mL)|inject separate from multimodal local anesthetic infiltration (0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg mixed NSS up to 75 mL)
15974948|NCT03074994|Procedure|TXA combined with multimodal local anesthetic infiltration inject into peri-articular area|(Anterior soft tissue 25 mL+Medial gutter area 25 mL+Lateral gutter area 25 mL) prior to capsular closure and tourniquet deflation
15974949|NCT03074994|Procedure|TXA 40 mL inject into intraaricular knee capsule|after multimodal local anesthetic infiltration (Anterior soft tissue 25 mL+Medial gutter area 25 mL+Lateral gutter area 25 mL) prior to tourniquet deflation
15974950|NCT03074981|Device|Combined TopClosure & Vcare Alpha|"Combined TopClosure & Vcare Alpha Treatment. The investigators will debride the wound if necessary. Wound biopsies will be taken to determine the existing pathogens and direct the antibiotic treatment.
~Wound measurements will be taken. Afterwards the wound will be approximated by the TopClosure device and the patient will be connected to a Negative Wound pressure device Vcare Alpha.
~The investigators will change dressings according to schedule. If the wound is clean the investigators will change dressings every 3-5 days, If the wound is infected the investigators will change dressings every 2-4 days, If the investigators encounter a severe infected wound with a lot of pus the investigators will change dressings every 1-3 days, The investigators will determine the time to heal when the wound is clean and there is no further need for Negative Pressure Wound Treatment (ROI-NPT) up to 10 weeks."
15974951|NCT03074968|Drug|Benzydamine Hydrochloride|Benzydamine Hydrochloride application
15974952|NCT03074968|Drug|Normal saline|normal saline application
15974953|NCT03074955|Device|leg wrapping with tension|"Apply elastic bandages with tension to both legs before injecting propofol.
~After 3 minutes, remove elastic bandages."
15974954|NCT03074955|Procedure|Trendelenburg position|"Apply Trendelenburg position positon of 10 degree after injectin propofol
~After 3 minutes, change to supine position"
15974955|NCT03074955|Device|leg wrapping without tension|"Apply elastic bandages without tension to both legs before injecting propofol.
~After 3 minutes, remove elastic bandages"
15974956|NCT03074955|Procedure|supine position|1.maintain supine position
15974957|NCT03074942|Drug|Reslizumab|Reslizumab 3 mg/kg once / every 4 weeks during 24 weeks
15974958|NCT03074929|Behavioral|Novel risk communication|The investigators will develop novel risk communication messages to communicate the risks of childhood obesity to parents of children with obesity. The investigators will consider several novel approaches around message content and framing, but primarily, we propose using microsimulation models to forecast a child's long-term health risks, based on his age, race, gender, BMI, and family history of CVD.
15974959|NCT03074916|Device|DIP arthroplasty or arthrodesis|Arthroplasty of the DIP Joint or arthrodesis of the DIP joint
15974960|NCT03074903|Device|Intrauterine system|Women having the Skyla intrauterine system at different times during their menstrual cycle report their bleeding patterns through daily texts.
15974961|NCT03074890|Device|Application Protocol|Application lMassive Transfusion Protocol
15974962|NCT03074877|Behavioral|Family Check-Up|The Family Check-Up (FCU) is a brief, family-based program to prevent Substance Use/Substance Use Disorder (SU/SUD) with replicated efficacy
15974963|NCT03074864|Drug|Erlotinib Hydrochloride|Subjects receive erlotinib tablet 150mg orally once daily, after 12 weeks of induction phase, local radiotherapy is intercalated, and followed by 24-week erlotinib maintenance phase. At the end of maintenance, the subjects enter into the follow-up period.
15974964|NCT03074851|Dietary Supplement|low sodium salt|To give free low sodium salt intervention for 2 months
15974965|NCT03074851|Other|informational intervention|to give reporter informational intervention.
15974966|NCT03074838|Procedure|Transarterial aortic valve implantation - TAVI|After insertion of a guidewire, either through the femoral artery or through the ascending aorta, the aortic ostium is dilated by a balloon and the valve is introduced through a catheter and expanded in the ostium.
15974967|NCT03074838|Procedure|Surgical aortic valve replacement - SAVR|The patient is operated through a sternotomy and coupled to a heart lung machine. The aorta is opened and the native valve excised. Then a biological artificial heart valve is sutured in place.
15974968|NCT03074825|Drug|Chiauranib|Take 50mg orally once daily
15974969|NCT03074812|Device|Transcranial Direct Current Stimulation|Transcranial direct current stimulation (tDCS) is a commonly used non-invasive form of brain stimulation for studying motor functions in health and disease [36]. It involves the attachment of surface electrodes to the scalp through which very small electric currents (1 or 2mA) are applied via a current regulated device. The currents do not produce any sensation. The applied current affects excitability of underlying neural tissue.
15975039|NCT03074435|Behavioral|IEC|A reinforced information, education and communication strategy will be implemented.
15975040|NCT03074422|Procedure|Hypnosis|Hypnosis session performed by a board certified senior anesthesiologist during the frame fixation on the patient's head.
15974970|NCT03074799|Other|Symptom -based Screening(Child Contacts)|"Aim 1: Determine the number of child contacts per adult index case of tuberculosis to assess quality of contact tracing.
~Aim 2: Determine the percentage of child contacts initiated on IPT or antituberculous therapy (ATT) and compare between intervention (symptom-based, nurse-led initiation of IPT) vs control clinics (TST-based screening with referral to hospital, current standard of care).
~Aim 3: Compare outcomes of children initiated on IPT between both groups including: completion of therapy, discontinuation due to side effects, lost to follow up, and adherence while on therapy."
15974971|NCT03074799|Other|Clinical based Decisions|the child is symptomatic, they will be referred to the hospital for further evaluation of TB disease including both chest X-ray and testing of either sputum or swallowed sputum. If the child is asymptomatic, the TB nurse at the local clinic will initiate them on weight-appropriate dosing of IPT
15974972|NCT03074786|Drug|Dapivirine|Silicone elastomer vaginal matrix ring
15974973|NCT03074786|Drug|Truvada|Tablets to be taken orally daily
15974974|NCT03074773|Drug|Dexamethasone|"Dexamethasone is commonly used in the perioperative period to reduce postoperative nausea and vomiting. Additionally, it has been reported to have analgesic effects.
~The analgesic effect of epidural or perineural dexamethasone administration is not clear. Dexamethasone might have a local anesthetic effect on nerve by direct membrane action"
15974975|NCT03074773|Device|ultrasound|The growth of ultrasound technology and, with it, our ability to visualize the pleura and other structures in and around the paravertebral space has fueled a tremendous increased interest in performing thoracic paravertebral blocks. These blocks may be used for acute pain control, as an adjunct to general anesthesia for peri-operative pain control and, in some practices, as the primary anesthetic
15974976|NCT03074773|Procedure|paravertebral block|paravertebral block is an effective analgesic technique used in various types of surgery, trauma and chronic pain. it decreases postoperative pain and reduces opioid consumption which in turns improve postoperative pulmonary function hoping for early extubation.
15974977|NCT03074773|Drug|Bupivacaine|it is an amino amide local anesthetic drug
15974978|NCT03074773|Other|isotonic saline|sterile sodium chloride solution at physiological concentration (0.87%); used as diluting agent when added to local anesthetic drug
15974979|NCT03074760|Diagnostic Test|Adenovirus|Diagnostic test for the presence of the adenovirus in the population groups
15974980|NCT03074760|Diagnostic Test|Rotavirus|Diagnostic test for the presence of the Rotavirus in the population groups
15974981|NCT03074760|Diagnostic Test|H. pylori|Diagnostic test for the presence of H. pylori infection in the population groups
15974982|NCT03074747|Diagnostic Test|questionnaires|After filled the questionnaires, the patients will receive the PSG monitoring
15974983|NCT03074734|Other|Exposure to secondhand tobacco smoke|The intervention is exposure to secondhand smoke of COPD and asthma patients in outside smoking areas (no specific drugs or devices are tested in this study). Study subjects will be asked to spend at least 15 minutes in the outdoor smoking area, a preferable time of 30-60 mins. During the exposure period (15-60 min) subjects´ respiratory rates will be recorded using RESpeck device, as well as the air quality which will be monitored using AirSpeck device.
15974984|NCT03074721|Device|PCI Suite Software|PCI with PCI Suite Software
15974985|NCT03074721|Other|conventional PCI|conventional PCI without PCI Software
15974986|NCT03074708|Other|3D visualization and 3D printing|From January 2016 to December 2018,the clinical data of 200 patients with the hepatobiliary and pancreatic diseases will be collected.All the patients received abdominal CT scanning and 3D reconstruction. Then we used the 3D reconstruction model and the 3D printed model based on the 3D reconstruction model in the operation planning and the operation.The clinical data include operative time, intraoperative blood loss,and postoperative complications after surgery.
15974987|NCT03074695|Procedure|Dural puncture epidural (DPE)|Epidural with spinal needle placed to confirm cerebral spinal fluid (CSF) position. No intrathecal dosing
15974988|NCT03074695|Procedure|Standard Epidural (EPL)|Standard epidural placement
15974989|NCT03074695|Drug|Dural puncture epidural (DPE)|Epidural with spinal needle placed to confirm CSF position. No intrathecal dosing. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
15974990|NCT03074695|Drug|Standard Epidural (EPL)|Standard epidural placement. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
15974991|NCT03074682|Device|Lifeflow|Following a 5-minute training video where instructions on device are presented to participants, participants are given the device, a 1L NS bag, tubing and a 22g IV. Prior to beginning the simulation, they will demonstrate ability to set up the device and fill an empty container with fluid.
15974992|NCT03074682|Device|Push/Pull|Following a 5-minute training video where instructions on device are presented to participants, participants are given the device, a 1L NS bag, tubing and a 22g IV. Prior to beginning the simulation, they will demonstrate ability to set up the device and fill an empty container with fluid.
15974993|NCT03074682|Device|Pressure Bag|Following a 5-minute training video where instructions on device are presented to participants, participants are given the device, a 1L NS bag, tubing and a 22g IV. Prior to beginning the simulation, they will demonstrate ability to set up the device and fill an empty container with fluid.
15974994|NCT03074669|Behavioral|ACT program|ACT program consists of seven modules that have been adapted for the online environment. Each module is structured like a therapy session with at least two homework assignments.
15974995|NCT03074656|Other|Therapeutic drug monitoring|Treatment algorithm based on assessments of serum drug levels and anti-drug antibodies
15974996|NCT03074656|Other|Standard care|Treatment algorithm based on standard clinical assessments, without knowledge of serum drug levels and anti-drug antibodies
15974997|NCT03074643|Behavioral|Weight loss intervention months 0-6|All participants will undergo a dietary weight loss intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The weight loss intervention will incorporate nutrition education (via group and individual meetings with the study dietitian), self-monitoring skills, cognitive-behavioral strategies for promoting lifestyle behavior modifications, and planned meals. Behavioral and educational group and individual sessions will be held weekly in a 3:1 ratio (3 group and 1 individual session per month).
15975041|NCT03074409|Drug|oxytocin|self-administration of oxytocin (nasal spray)
15975042|NCT03074409|Drug|placebo|self-administration of placebo (nasal spray)
15975186|NCT03073226|Device|Olympus Spectrum|Current generation Olympus endoscope
15974998|NCT03074643|Behavioral|Exercise intervention months 0-6|All participants will be expected to participate in a supervised, center-based exercise program involving moderate-intensity aerobic exercise (e.g., treadmill walking) 3 days/wk during the 6-month weight loss intervention in accordance with the American Heart Association and the American College of Sports Medicine physical activity recommendations for older adults.
15974999|NCT03074643|Dietary Supplement|Carbohydrate supplement for months 0-6|Participants in the lower protein / higher CHO diet group (RecProt) will be provided a carbohydrate supplement (~50 g of carbohydrate and 220 calories) to consume daily during the 6 month weight loss intervention.
15975000|NCT03074643|Dietary Supplement|Protein supplement for months 0-6|Participants in the higher protein / lower CHO diet groups (6-mon HiProt and 18-mon HiProt) will be provided a protein supplement (~50 g of protein and 220 calories) to consume daily during the 6 month weight loss intervention.
15975001|NCT03074643|Dietary Supplement|Protein supplement for follow-up months 7-18|Participants in the higher protein / lower CHO diet (18-mon HiProt) will be provided a protein supplement (~50 g of protein and 220 calories) to consume daily during the 12-month follow-up.
15975002|NCT03074630|Drug|Dapagliflozin|5 weeks 10mg dapagliflozin once daily
15975003|NCT03074630|Drug|Rosuvastatin|9 weeks 10mg dapagliflozin once daily
15975004|NCT03074617|Other|LTE field|electromagnetic field of the latest standard in mobile communication (long term evolution, LTE)
15975005|NCT03074617|Other|sham field|no electromagnetic field
15975006|NCT03074604|Procedure|aortic no-touch OPCABG|(Study arm 1) In this intervention only the internal mammary artery grafts will be used (i.e. left internal mammary artery graft, right internal mammary artery graft, or a Y-graft that uses right internal mammary artery graft anastomosed onto left internal mammary artery graft to allow for a wide territory of myocardial revascularization). However, in the rare event that the aforementioned approach is insufficient to reach all target vessels, a reversed (great) saphenous vein graft may be used to extend the left internal mammary artery graft or the right internal mammary artery graft.
15975007|NCT03074604|Procedure|OPCABG with partial clamp applying carbon dioxide|(Study arm 2) In this intervention chest cavity will be insufflated with carbon dioxide at a flow above 5 l/min during the entire surgical procedure.
15975008|NCT03074604|Procedure|OPCABG with partial clamp|"(Study arm 3) This is the control arm undergoing traditional OPCABG with partial clamp."
15975009|NCT03074591|Drug|Ferric Carboxymaltose 50Mg/Ml Inj 15Ml|After baseline assessments patients will be randomised in a 1:1 ratio to receive Ferric Carboxymaltose IV or placebo/saline (normal saline: 0.9% w/v NaCl). In the Treatment group, Ferric Carboxymaltose will be administered according to the dosing schedule.
15975010|NCT03074591|Drug|Saline Solution for Injection|In the placebo/saline group, patients will receive the aequivalent number of normal saline infusions.
15975011|NCT03074578|Behavioral|Watching Video-clip 1|Video -clip 1 contains violent images and text
15975012|NCT03074578|Behavioral|Watching Video-clip 2|Video -clip 2 contains neutral images and text
15975013|NCT03074565|Device|Ultrasonic alone|Sanative therapy using ultrasonic instrumentation alone
15975014|NCT03074565|Device|Ultrasonic+|Sanative therapy using ultrasonic plus hand instrumentation
15975015|NCT03074552|Dietary Supplement|LactoLevure|The probiotic preparation will consist a combination of four probiotics: Lactobacillus acidophilus LA-5 1.75 × 109 CFU, Lactobacillus Plantarum 0.5 × 109 CFU, Bifidobacterium lactis BB-12 1.75 × 109 CFU και Saccharomyces boulardii 1.5 × 109 CFU per capsule (LactoLevure, UniPharma, Athens, Greece).
15975016|NCT03074552|Other|Placebo|Placebo will consist of identical capsules of powdered glucose polymer
15975017|NCT03074539|Drug|Riociguat|Patients will be treated with Riociguat according to guidelines (2015 ERS/ESC guidelines for the diagnosis and treatment of pulmonary hypertension) and manufacturers recommendation.
15975018|NCT03074539|Procedure|Pulmonary Endarteriectomy|Patients will receive Pulmonary Endarteriectomy if they are suitable for this procedure according to the recommendation of the local CTEPH board. Patients must also consent to this surgical procedure.
15975019|NCT03074539|Procedure|Ballon Pulmonary Angioplasty|Patients will receive Ballon Pulmonary Angioplasty if they are suitable for this procedure according to the recommendation of the local CTEPH board (e.g. not suitable for PEA). Patients must also consent to this procedure.The BPA will be accomplished in several interventions.
15975020|NCT03074526|Other|Amniotic Fluid|Amniotic Fluid
15975021|NCT03074526|Other|Saline Placebo|Saline Placebo
15975022|NCT03074513|Drug|Atezolizumab|Given IV
15975023|NCT03074513|Biological|Bevacizumab|Given IV
15975024|NCT03074513|Other|Laboratory Biomarker Analysis|Correlative studies
15975025|NCT03074513|Other|Pharmacological Study|Correlative studies
15975026|NCT03074500|Device|Kinesiotaping|Kinesio tape will be applied by using space correction and fascia correction technique on forearm of the patients for the treatment of lateral epicondylitis
15975027|NCT03074500|Other|Sham taping|Sham taping will be performed without using any technique
15975028|NCT03074500|Other|Exercise|Stretching exercises of wrist 30 seconds to one minute, twice a day and strengthening exercises will performed be 10 repetitions in 2 or 3 series. .
15975029|NCT03074487|Device|Near-infrared spectroscopy|
15975030|NCT03074487|Device|Long loop reflex measurements|
15975031|NCT03074474|Device|OviTex Permanent 1S|OviTex 1S is a reinforced bioscaffold consisting of layers of extra-cellular matrix derived from sheep stomachs. The layers are embroidered together with a monofilament polypropylene. One side of the mesh has blue polypropylene stitching, which provides a surface conducive to native tissue growth. The other side of the mesh is a smooth surface intended to minimize tissue attachment (adhesions).
15975032|NCT03074461|Procedure|Side-to-End Anastomosis|During the scheduled low anterior resection (LAR) in patients with distal rectal cancer and anticipated anastomosis in the mid or distal rectal third, the reconstruction phase of the LAR consists of the implementation of a side-to-end colorectal anastomosis.
15975033|NCT03074461|Procedure|Transverse Coloplasty|During the scheduled low anterior resection (LAR) in patients with distal rectal cancer and anticipated anastomosis in the mid or distal rectal third, the reconstruction phase of the LAR consists of the implementation of a transverse coloplasty pouch. For this purpose an end-to-end colorectal anastomosis is initially performed, followed by a longitudinal incision of approx. 8-10 cm length proximal of the anastomosis and a subsequent transverse suture in terms of the coloplasty technique.
15975043|NCT03074396|Device|Use of DialysisNet for doctor|DialysisNet is mobile application for physicians for haemodialysis patients. Patient-centred data integration and exchange were based on the American Society for Testing and Materials Continuity of Care Record standard.
15975044|NCT03074396|Device|Use of Avatar Beans for patient|Avatar Beans is mobile application for haemodialysis patients. Patient-centred data integration and exchange were based on the American Society for Testing and Materials Continuity of Care Record.
15975045|NCT03074383|Behavioral|Workshop|A 15-minute Individual meetings with each professional (nurse, pharmacist, nutritionist, physical educator, physiotherapist and social worker) of the multidisciplinary team in which diabetes education and self-care topics will be approached.
15975046|NCT03074383|Behavioral|Usual Care|Usual care at outpatient Diabetes clinic AND 3 brief meetings with research team to receive printed educational material.
15975047|NCT03074344|Device|XLHA+CoQ10|XLHA+CoQ10 for four times a day for 12 weeks.
15975048|NCT03074344|Device|Hyaluronic acid (HA)|Hyaluronic acid (HA) for four times a day for 12 weeks.
15975049|NCT03074331|Drug|SOF/VEL|400/100 mg FDC tablet(s) administered orally once daily
15975050|NCT03074318|Drug|Avelumab|Given IV
15975051|NCT03074318|Drug|Trabectedin|Given IV
15975052|NCT03074305|Device|PCI for in-bioresorbable scaffold stenosis|"In patients who have in-bioresorbable scaffold stenosis after bioresorbable scaffold implantation, PCI will performed according to the allocated arms
~DEB strategy
~DES strategy"
15975053|NCT03074292|Procedure|phototherapy|estimate oxidative stress and trace elements in neonates with unconjugated hyperbilirubinemia after exposure to phototherapy
15975054|NCT03074279|Other|Interview with a psychologist and self-reported questionnaires|The family members or patients who decide to participate in the study will be asked to complete an interview with a psychologist (semistructured interview, standard form, questionnaires) and self-reported questionnaires
15975055|NCT03074266|Diagnostic Test|GEM Hemochron 100 ACT|Activated Clotting Time
15975056|NCT03074253|Diagnostic Test|Echocardiography|Patients are undergoing echocardiography
15975057|NCT03074253|Diagnostic Test|magnetic resonance imaging|Patients are undergoing magnetic resonance imaging
15975058|NCT03074253|Diagnostic Test|computed tomography|Patients are undergoing computed tomography
15975059|NCT03074253|Diagnostic Test|blood withdrawl|Peripheral blood samples are being collected from all patients
15975060|NCT03074240|Procedure|TAPB Group|Subjects allocated to the TAPB group will be monitored for instances of intraoperative local anesthetic supplementation, analgesic administration, or conversion to general anesthesia will be compared.
15975061|NCT03074240|Procedure|RSB Group|Subjects allocated to the RSB group will be monitored for instances of intraoperative local anesthetic supplementation, analgesic administration, or conversion to general anesthesia will be compared.
15975062|NCT03074240|Procedure|conversion to general anesthesia|For those who do not respond to TAPB or RSB to allow for completion of the intended procedure.
15975063|NCT03074227|Other|Allogeneic faecal transplantation|"Patients will get bowel lavage through a nasoduodenal tube. This bowel lavage consists of 2-3 litres of macrogol electrolytes (Klean-Prep) solution. After that, patients will be treated with allogeneic faecal microbiota transplantation via the nasoduodenal tube.
~Faeces will be collected from a donor."
15975064|NCT03074227|Other|Autologous faecal transplantation|Patients will get bowel lavage through a nasoduodenal tube at our centre. This bowel lavage consists of 2-3 litres of macrogol electrolytes (Klean-Prep) solution. After that, patients will be treated with autologous faecal microbiota transplantation via the nasoduodenal tube.Faeces will be collected from the patient him/herself, in which their own faeces (autologous) will be used as a placebo.
15975065|NCT03074214|Procedure|percutaneous coronary intervention|"All STEMI patients enrolled will at first receive Device(such as: stent or balloon) treatment for their coronary artery."
15975066|NCT03074201|Procedure|Cholangioscopy|Cholangioscopy used instead of fluoroscopy-based ERCP to facilitate clearance of bile duct stones.
15975067|NCT03074201|Device|Spyglass DS Cholangioscope|Cholangioscopy used instead of fluoroscopy-based ERCP to facilitate clearance of bile duct stones.
15975068|NCT03074175|Radiation|radiotherapy|The patient in supine position with hands catch the plate column by crossing the head, and body fixed by vacuum mould. An enhanced 4DCT scan is conducted with a layer thickness and a distance each of 5 mm. the imaging information is input into the Eclipse program system,the gross tumor volume of the primary tumor (GTVt) and pathological lymph nodes (GTVn) are delineated,GTV is expanded in all 3D direction to create PGTV by 5mm margin for squamous cell carcinoma, or an 8mm margin for adenocarcinoma.Radiaion therapy is delivered by 5F-IMRT.For conventional fractionated radiotherapy,the prescribed dose covering 95% of PGTV is 60Gy/30F/6W.For hyperfractionated radiotherapy,the prescribed dose covering 95% of PGTV is 50Gy/11F/2W.lung V20 <25%, lung V30 <18%, spinal cord <36 Gy.
15975069|NCT03074162|Drug|Diclofenac Sodium|twice daily
15975070|NCT03074162|Drug|Diclofenac & Capsaicin|twice daily
15975071|NCT03074162|Drug|Diclofenac Sodium Topical Gel|twice daily
15975072|NCT03074136|Device|Photodinamic therapy|Dentin sealant (HELBO® Endo Seal, Bredent, Senden, Germany) will be applied over the crown area and light cured. The root canals will be filled with the phenothiazine chloride (HELBO® Endo Blue, Bredent, Senden, Germany), agitated with a size 15K-file and left in the canal for 2 min. After this time, the root canals will be rinsed with distilled water to remove the excess of the photosensitizer, dried with paper points. The disposable 450 µm fiberoptic tip (3D HELBO® Endo Probe, Bredent, Senden, Germany) will be placed in the apical portion of the root canal at the point where resistance to the fiber will be felt, and root canal will be irradiated with HELBO® TheraLite Laser (λ = 660 nm, power = 100 mW) for 60 s (total energy, 6 J) in a continuous wave mode.
15975073|NCT03074136|Device|Diode laser|High-power diode laser therapy will be applied by using Epic diode laser (Biolase® Technology, Inc., San Clemente, CA, USA) with settings determined in laboratory researches (λ = 940 nm, maximal power 10W).
15975074|NCT03074136|Drug|0.5% Sodium hypochlorite|Chemomechanical preparation will be completed by hand instruments, with minimal instrumentation, and usage of sodium hypochlorite with minimal bactericidal concentration (0.5%, pH 12), on room temperature (21 degrees Celsius).
15975117|NCT03073785|Drug|Capecitabine|Given PO
15975118|NCT03073785|Drug|Fluorouracil|Given IV
15975119|NCT03073785|Other|Laboratory Biomarker Analysis|Correlative studies
15975120|NCT03073785|Other|Pharmacological Study|Correlative studies
15975075|NCT03074123|Diagnostic Test|low-dose cosyntropin stimulation test|Each subject recruited in the study will undergo low dose cosyntropin stimulation test via intravenous short 2.5 cm plastic tube. 1 μg/ml ACTH aliquot stock solution will be pushed through, followed by 5 ml physiologic saline (0.9%). For each subject, serum and salivary cortisol will be measured just before cosyntropin administration and 30 minutes later.
15975076|NCT03074110|Device|Isocapnic hyperventilation|Mechanical hyperventilation to enhance elimination of inahalation anesthetics. Administration of a precalculated flow of CO2 according to gender and weight into the inspiratory limb of the breathing circuit in order to avoid hypocapnia.
15975077|NCT03074097|Drug|Bupivacaine 0.25%|Each patient received bilateral single shot ultrasound guided rectus sheath block under complete aseptic condition in a dose of 30 ml of bupivacaine 0.25% in each side immediately after induction of general anaesthesia
15975078|NCT03074071|Behavioral|Hope Enhancement Workshop|Participants in the workshops will be prompted and guided through exercises that help them get in touch with goals that are not explicitly related to cure of disease. These goals will include symptom relief and other personal and or professional objectives.
15975079|NCT03074058|Drug|Fosrenol ODT (Lanthanum Carbonate, BAY77-1931)|Fosrenol orally disintegrating tablet, ODT (Lanthanum Carbonate, BAY77-1931) 500 mg, TID
15975080|NCT03074058|Drug|Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931)|Fosrenol chewable Tablet (Lanthanum Carbonate, BAY77-1931) 500mg, TID
15975083|NCT03074032|Drug|ONC1-0013B|ONC1-0013B per os daily
15975084|NCT03074019|Dietary Supplement|Xylooligosaccacharide|XOS95 powder
15975085|NCT03074019|Dietary Supplement|Maltodextrin|Maltodextrin powder
15975086|NCT03074006|Drug|TEW-7197|50mg tablets (doses will be determined through dose-escalation part)
15975087|NCT03073993|Procedure|feeding tube insertion|Feeding tube was inserted in hemodynamically stable babies for purpose of feeding
15975088|NCT03073980|Drug|IV Acetaminophen|IV Acetaminophen for pain control during procedure
15975089|NCT03073980|Drug|PO Acetaminophen|PO Acetaminophen for pain control during procedure
15975090|NCT03073980|Other|Placebo IV Acetaminophen|Placebo IV Acetaminophen
15975091|NCT03073980|Other|Placebo PO Acetaminophen|Placebo PO Acetaminophen
15975092|NCT03073967|Drug|Pritelivir|100 mg tablets
15975093|NCT03073967|Drug|Foscarnet|Solution for iv infusion
15975094|NCT03073954|Other|Working memory training|"The working memory intervention training programme consists of a domain-general cognitive working memory training programme. One training session will take 20 to 30 minutes, and participants will have to complete approximately 40 cognitive training sessions.
~The sham treatment is the same as the intervention training however it does not increase in difficulty. Participants are presented with the same task at the same level of difficulty over and over again. Thus a training effect is not expected."
15975095|NCT03073954|Behavioral|Standardised healthy lifestyle coaching|Participants will receive standardised healthy living coaching focusing on healthy diet and daily physical activity.
15975096|NCT03073941|Device|Persona total knee system|314 participants with knee osteoarthritis set to receive primary total knee arthroplasty will receive either Persona knee or the Nexgen
15975097|NCT03073941|Device|Nexgen total knee system|314 participants with knee osteoarthritis set to receive primary total knee arthroplasty will receive either Persona knee or the Nexgen
15975098|NCT03073928|Procedure|Interscalene Block|Regional Anesthesia procedure in the neck
15975099|NCT03073928|Procedure|Paracoracoid SPB|Regional anesthesia procedure under the collar bone
15975100|NCT03073928|Drug|Ropivacaine|Amide local anesthetic Ropivacaine will be used in same concentration (milligrams) in both active comparator and experimental group
15975101|NCT03073902|Diagnostic Test|Liquid biopsy|Liquid biopsy
15975102|NCT03073889|Procedure|Scalp Nerve Block|A scalp nerve block involves regional anesthesia to the nerves that innervate the scalp, including the supraorbital and supratrochlear nerves, branches of the ophthalmic branch of the trigeminal nerve; the zygomaticotemporal nerves, terminal branch of division two of the trigeminal nerve; the auriculotemporal nerves, terminal branch of the mandibular division of the trigeminal nerve; the greater and lesser occipital nerves. The scalp block is performed bilaterally with 10 solution of 0.75% ropivacaine.
15975103|NCT03073889|Procedure|Scalp infiltration|Scalp infiltration before incision. Neurosurgeons infiltrate the planned incision by a 22-gauge needle penetrated deeply to the skin at a 45°angle with 10ml solution of 0.75% ropivacaine throughout the entire thickness of the scalp.
15975104|NCT03073889|Drug|Ropivacaine|
15975105|NCT03073876|Drug|Donepezil Hydrochloride|5mg of Donepezil Hydrochloride by mouth
15975106|NCT03073876|Drug|Placebo|prepared placebo looking exactly the same as drug. Participants took placebo by mouth for approximately 6 weeks, and after unblinding, they took donepezil hydrochloride for 6 months.
15975107|NCT03073863|Drug|Atorvastatin|Analysis
15975108|NCT03073850|Drug|Antiplatelet|ASA or clopidogrel
15975109|NCT03073850|Drug|Low dose oral anticoagulant|Edoxaban of 30mg
15975110|NCT03073850|Drug|Standard dose oral anticoagulant|Edoxaban of 60mg
15975111|NCT03073837|Other|Rhinovirus Challenge|Challenge with HRV-16 virus
15975112|NCT03073824|Device|vSculpt|Pelvic Floor Toning and Vaginal Rejuvenation Device
15975113|NCT03073811|Dietary Supplement|Protein enhanced nutrition intervention|Participants will be provided 30 grams of high quality protein (Ensure Max) three times a day for two weeks before surgery and four weeks after surgery.
15975114|NCT03073811|Other|Education Control|provided educational on the role of nutrition to prepare for and heal from surgery, and Registered Dietitian will instruct participant to follow instruction on handout and one oral nutrition supplement per day for two week before surgery.
15975115|NCT03073798|Drug|Roflumilast|500 mcg of Roflumilast which is a prescription medicine used in adults with severe COPD to decrease the number of flare-ups or the worsening of COPD symptoms
15975116|NCT03073798|Drug|Placebo|500 mcg of placebo is used
15975123|NCT03073772|Behavioral|Computer-based cognitive training|A total of 36 training sessions, approximately 20 minutes long each. Five different tasks were used in training all tapping different aspects of cognitive control such as updating, shifting, visuo-spatial working memory and episodic memory binding.
15975124|NCT03073772|Behavioral|Physical fitness training|A total of 36 training sessions, approximately 40 minutes long each, with physical fitness training performed as group indoor cycling. The participants were instructed to attain a load of approximately 65-80% of their maximum heart rate.
15975125|NCT03073759|Device|dTCS|Direct current (DC) (maximum of 2 mA) stimulation delivered through surface electrodes. One electrode will be positioned above the left or right primary motor cortex, the other electrode over the forehead.
15975126|NCT03073759|Device|Sham device|The device will administer a sham.
15975127|NCT03073746|Other|Health Search|
15975128|NCT03073746|Other|Standard Search|
15975129|NCT03073733|Biological|human retinal progenitor cells|live suspension of 3.0 or 6.0 x 10e6 human retinal progenitor cells (hRPC) suspended in clinical grade medium injected intravitreally under local anesthesia
15975130|NCT03073733|Other|Mock injection|pressing the hub of a syringe with no needle against the eye to mimic intravitreal injection
15975131|NCT03073707|Behavioral|Sample collection|Stool samples will be collected from household members of children diagnosed with NTS infection. In addition stool samples of animals and rats will be collected as well as samples of the water supply of the household.
15975132|NCT03073694|Drug|Mitomycin c|Mitomycin-c will be given to participants in Treatment Arm 1 as a one-time, intraoperative, intravenous administration for a duration of 90 minutes. 45 minutes into the perfusion, a maintenance dose will be administered.
15975133|NCT03073694|Drug|Melphalan|Melphalan will be given to participants in Treatment Arm 2 as a one-time, intraoperative, intravenous administration for a duration of 90 minutes.
15975134|NCT03073681|Device|Survey|Patients will complete a survey describing their satisfaction with vision after cataract surgery that was performed at least 2 months prior to study enrollment.
15975135|NCT03073668|Procedure|Anterior pericardiotomy|The surgical team will perform anterior pericardiotomy. This will not be a complete pericardiectomy but rather a limited anterior incision to gain access to the heart for surgical exposure.
15975136|NCT03073668|Drug|Saline|During the measurement of cardiac hemodynamic tests, a saline bolus of 300 ml will be administered over 1-2 minutes.
15975137|NCT03073655|Other|Negative Verbal Input|The treatment group received a standardized therapeutic KT application. The physical therapist said that it has been limited evidence of KT is effective during application.
15975138|NCT03073655|Other|Neutral Verbal Input|The treatment group received a standardized therapeutic KT application. The physical therapist said that it has been not known that KT is effective or not during application.
15975139|NCT03073655|Other|Positive Verbal Input|The treatment group received a standardized therapeutic KT application. The physical therapist said that it has been known that KT has excellent result during application.
15975140|NCT03073642|Other|Pain Education|Together with hydrotherapy, patients will receive pain therapeutic education
15975141|NCT03073642|Other|Hydrotherapy|Hydrotherapy sessions, lasting 45 minutes, twice a week for 12 weeks.
15975142|NCT03073629|Diagnostic Test|Clinical Pathway|Patients will be evaluated and managed in a specialized cardiovascular clinic to determine the etiology of right heart failure and begin treatment.
15975143|NCT03073616|Device|Lung ultrasound|Lung ultrasound and chest RX
15975146|NCT03073590|Combination Product|Intervention factory with hot lunch|A nutritionally enhanced lunch meal program (increased dietary diversity plus inclusion of multi-nutrient fortified rice), provision of once weekly iron/folate supplement to female workers, and a BCC program conducted in the factory setting focused on improving health and nutrition for women and children, with a focus on anemia prevention.The BCC program will be enhanced to include modules on nutrition (balanced diets/dietary diversity, iron/folate rich foods), infant and young child nutrition (IYCN), and an overview module on anemia prevention, hand-washing with soap and dietary diversity at the very beginning of the intervention.
15975147|NCT03073590|Combination Product|Intervention factory without lunch program|In a selected garment factory that does not have a lunch program, the intervention will consist of the twice weekly provision of iron/folate supplements to female workers, and the enhanced BCC program, as described above.
15975148|NCT03073590|Combination Product|Control factory with lunch program|One control factory who provides regular lunch meal and a nutrition and health behavior change communications (BCC) program.
15975149|NCT03073590|Behavioral|Control factory without lunch program|One control factory was selected where only the standard Behavior change communication (BCC) was implemented.
15975150|NCT03073577|Drug|Antiaging Glycopeptide|Antiaging Glycopeptide (PKX-001) will be supplemented to islet preservation medium during islet isolation process. On the day of transplantation, preserved islets supplemented with PKX-001 are collected and washed with Transplant Media, which does not contain PKX-001, as a standard procedure. The isolation team will evaluate the final islet product based on standard assays used in standard of care practice. When product release minimal criteria are met, islets will be clinically transplanted into patients intraportally by percutaneous transhepatic access.
15975151|NCT03073564|Diagnostic Test|Endurance test for upper limbs|Subjects will initially perform maximal incremental cardiopulmnar test of upper limbs to assess the suggestion of dynamic hyperinflation (DH). After that, it will be randomized, for those who presented DH, to perform the endurance test with and without the use of positive expiratory pressure mask.
15975152|NCT03073564|Diagnostic Test|Functional test|The 6-min pegboard and ring test (6PBRT) will be performed under usual breathing and during application of the EPAP mask. In this condition will be evaluated the presence of dynamic hyperinflation, perception of effort and dipnea, in addition to exercise capacity.
15975187|NCT03073213|Drug|Ixekizumab|Administered as subcutaneous (SC) injection
15975188|NCT03073200|Drug|Ixekizumab|Administered SC
15975189|NCT03073200|Drug|Placebo|Administered SC
15975153|NCT03073551|Other|Wii Group|Participants in the Wii group will be given a Wii console and video game to take home. The console includes a Wii balance board and remote controller. The Wii Fit game allows participants to choose different types of exercise such as yoga, aerobics, balance training, and more. Participant movements are shown on screen as they move with the balance board and remote control.
15975156|NCT03073512|Other|Ultrasound examination|Participants will undergo ultrasound examination at 32 weeks gestation
15975157|NCT03073499|Procedure|Oncological Home Hospitalization|
15975158|NCT03073486|Drug|Olumacostat Glasaretil Gel, 5.0%|Gel containing Olumacostat Glasaretil
15975159|NCT03073486|Other|Olumacostat Glasaretil Gel, Vehicle|Vehicle (placebo) gel
15975160|NCT03073473|Diagnostic Test|NantHealth GPS Cancer Test|Quantitative targeted proteonomics detected by mass spectrometry with whole genome (DNA) and whole transcriptome (RNA) sequencing.
15975161|NCT03073460|Other|Ultrasound examination|This exam is performed at 40 weeks gestation
15975162|NCT03073447|Other|Specific blood sample of women under 50 years with acute MI|The specific assays, corresponding to the tests carried out as part of the WAMIF study will be sampled before discharge. Some assays, including hormonal and thrombophilia will be centralized in order to standardize the results and their interpretation. All the biological data will be pooled and analyzed by IVS. a sample of blood will be made for later analysis in the context of a serum bank.
15975163|NCT03073421|Other|Qualitative interview|This interview will be 2 hours in length and will be conducted with a Peer Research Assistant (PRA). The PRAs will be women living with HIV.
15975164|NCT03073408|Drug|Propofol|Closed loop control for propofol administration guided by the BIS.
15975165|NCT03073408|Drug|Propofol|Manual control group: Propofol administration adjusted manually.
15975166|NCT03073395|Drug|[68Ga]P16-093|Imaging by Positron Emission Tomography after iv injection of [68Ga]P16-093
15975167|NCT03073382|Other|Chart review|This is a chart review of all patients who have underwent open prenatal repair of fetal myelomeningocele. Although prenatal repair is associated with improved neurologic outcomes and a decreased need for cerebrospinal fluid shunting after birth, one of the major risks is preterm delivery. This study is intended to identify maternal, fetal or intraoperative risk factors associated with preterm delivery.
15975168|NCT03073369|Drug|Ergocalciferol 50000 UNT|Oral Ergocalciferol 50000 IU once daily for 6 weeks
15975169|NCT03073369|Drug|Placebo|Oral Placebo - one capsule once daily for 6 weeks
15975170|NCT03073356|Biological|Infusion of 3-OHB|Increase in 3-OHB levels
15975171|NCT03073356|Biological|Infusion of placebo|NaCl
15975172|NCT03073343|Dietary Supplement|Betaine (trimethyglycine)|Betaine (trimethyglycine) is a food supplement that is approved for sale in the United States without a prescription. In this study, betaine will be provided to patients as a powder that can be mixed with aqueous solutions and consumed orally.
15975173|NCT03073330|Diagnostic Test|GDM screening with 75 g 2 hour GTT|Patients will be diagnosed with gestational diabetes if they have one abnormal value: Fasting ≥ 92; 2 hour ≥ 180 mg/dl;1 hour ≥ 153 mg/dl.
15975174|NCT03073330|Diagnostic Test|GDM screening with two step approach|1 hour glucola with 50 g glucose load followed by 100 g glucose load if 1 hour glucola positive
15975175|NCT03073317|Diagnostic Test|FullPIERS and sFlit/PLGF (Soluble fms-Like Tyrosine Kinase-1-to-Placental Growth Factor Ratio)|Once the centre is randomised to receive the intervention, all eligible women will have serum sFlt1/PlGF measurement performed and fullPIERS assessment and both results will be revealed to the care providers. This will include all women with pre-eclampsia or suspected pre-eclampsia cared for at the main hospital centres (and not be limited to women referred to the hospital from the community health centres). sFlt-1/PlGF will be tested by immunoassays (Roche Platform®). The result read out is provided by specific machines provided by Roche in less than one hour, which permits rapid clinical decision-making. Risk stratification using fullPIERS will be performed on tablet computers using a pre-defined risk scoring system integrated within the MedSciNet database.
15975176|NCT03073304|Drug|Crystalloid based prime solution|Crystalloid based prime solution
15975177|NCT03073304|Drug|Erythrocyte based prime solution|Erythrocyte based prime solution
15975178|NCT03073291|Behavioral|Responsible Marijuana Vendor Training|Employees at retail recreational marijuana stores assigned to the the responsible marijuana vendor training will register them on TrainToTend online training program, create a user profile, and complete the training within four weeks from initial registration. Personnel who complete the training will receive a certificate of completion. New hires at the stores during the trial will be registered and complete the training within four weeks of commencing work. Separate versions of the training will be available reflecting differences in the laws/regulations on recreational marijuana sales in Colorado, Oregon, and Washington State and the content will be reviewed and approved by state regulators.
15975179|NCT03073278|Radiation|Stereotactic Body Radiotherapy|Each group will have different dose of stereotactic body radiotherapy (SBRT). Depending on which group patients are in.
15975180|NCT03073265|Device|STA-Apixaban Calibrator & Control|Measurement of apixaban level will be done using anti-Xa assay (IVD).
15975181|NCT03073252|Other|Normal Protein|Consumption of a normal protein (NP), egg-based (13 g protein; whole eggs) breakfast bowl
15975182|NCT03073252|Other|HIgh Protein|Consumption of a high protein (HP), egg-based (30 g protein; whole eggs) breakfast bowl
15975183|NCT03073239|Genetic|ALS patients genetic characterization|Genetic findings in ALS patients
15975184|NCT03073239|Other|ALS patients epidemiological caracterization|Epidemiological characterization in ALS patients
15975191|NCT03073148|Device|Tangible Boost|Participants will treat their lenses with Tangible Boost, a kit designed to maintain the wettability of Hydra-PEG treated fluorosilicone acrylate lenses.
15975192|NCT03073148|Other|Placebo saline|"Participants will treat their lenses with a placebo Tangible Boost kit, which contains saline in place of the Tangible Boost solution."
15975193|NCT03073135|Behavioral|Psychodrama Group Therapy (PGT)|"The psychotherapeutic focus is on the here and now aspect of the patient's relationships. Conflicts are acted out during the sessions, yielding intense emotional re-experience in a safe environment, which will bring further cognitive understanding of past distressful life experiences and hopefully new adaptive ways of expressing and dealing with the problem."
15975194|NCT03073135|Behavioral|Supportive Group Therapy (SGT)|SGT is a form of treatment in which the therapist maintains a therapeutic relationship and a working alliance based on reality, support, clarification, assistance in troubleshooting, strong leadership, partial gratification of dependency needs, legitimating independence, development of pleasurable activities and adequate rest, guidance and advice to deal with current problems. This approach uses techniques to help patients feel safe, accepted, protected, encouraged and not anxious.
15975195|NCT03073122|Diagnostic Test|Brain MRI, neurocognitive and psychological testing|MRI of the brain and multiple tests of neurocognitive and psychological function including executive function, anxiety and depression
15975196|NCT03073096|Procedure|LVA at time of nodal dissection|Patients will receive a lymphatic-venous anastomosis at time of their required nodal dissection
15975197|NCT03073083|Procedure|Hamstring tendon autograft|ACL reconstruction surgery with hamstring tendon
15975198|NCT03073083|Procedure|Pattella tendon autograft|ACL reconstruction surgery with patella tendon
15975199|NCT03073083|Procedure|Quadriceps tendon autograft|ACL reconstruction surgery with quadriceps tendon
15975200|NCT03073070|Drug|biotin labeled RBCs|Autologous red blood cells are biotin labeled and transfused to the subjects. Survival of these red blood cells is tracked through examination of blood samples until no biotin-labeled red blood cells is detectable.
15975201|NCT03073057|Drug|Budesonide/formoterol|2 inhalations as a single dose
15975202|NCT03073057|Other|Charcoal|
15975203|NCT03073057|Drug|Symbicort Turbuhaler|2 inhalations as a single dose
15975204|NCT03073044|Diagnostic Test|BELASTUNGSFRAGEBOGEN PARKINSON KURZVERSION (BELA-P-K)|"we proposed the translation and validation of Bela-p-K, a questionnaire that evaluates the Quality of Life in parkinsonian patients.
~we applied the method of translation and back-translation at dutch version of questionnaire. after, we evaluated 103 PD patients with Bela-p-K and PDQ39.
~The internal consistency of questionnaire was analyzed calculating alpha-Chronbach. We also evaluated the construct validity correlating Bela-p-K and PDQ39"
15975205|NCT03073031|Device|Tablet: Samsung Galaxy Tab A|
15975206|NCT03073018|Drug|Fosinopril|oral administration, capsules
15975207|NCT03073018|Drug|Pravastatin|oral administration, capsules
15975208|NCT03073018|Drug|Fosinopril Placebo|oral administration, capsules
15975209|NCT03073018|Drug|Pravastatin Placebo|oral administration, capsules
15975210|NCT03073005|Other|Simulation-based Mastery Learning (SBML)|The SBML training group will first 1) watch the VAD video, then 2) participate in a SBML intervention using the simulator for a) driveline exit site sterile dressing changes; b) performing controller self-tests; c) changing power sources; d) troubleshooting emergent VAD-related malfunction; and e) recognizing specific signs and symptoms requiring immediate contact with the VAD team.
15975211|NCT03072992|Drug|Curcumin|Curcumin (CUC-01), 300mg i.v. , once weekly for 12 weeks.
15975212|NCT03072992|Drug|Paclitaxel|Paclitaxel (colorless solution) 80 mg /m2 BS, i.v., once weekly for 12 weeks.
15975213|NCT03072992|Drug|Placebo|Placebo i.v. solution, once weekly for 12 weeks
15975214|NCT03072979|Radiation|Stereotactic body radiotherapy|Stereotactic body radiotherapy
15975215|NCT03072966|Device|Wearable device (Fitbit Charge HR® or Fitbit Alta ®)|Physical activities will be monitored by wearable device.
15975216|NCT03072953|Drug|APD334|APD334 active treatment
15975217|NCT03072940|Other|Clinical investigations|Clinical examination, motor, cognitive, autonomous, psychological, olfactory and color vision tests, and rapid eye movement sleep characterization using video-polysomnography and 3 T magnetic resonance imaging
15975219|NCT03072914|Procedure|RIPC with RIPostC|The sphygmomanometer is closed to the lower limb and the cuff is inflated and the pressure is increased by 30 mmHg higher than the systolic blood pressure of each patient for 5 minutes. The loss of the distal pulse is confirmed by Doppler in the dorsalis pedis pulse. If there is a pulse, increase the pressure until it disappears. After 5 minutes of ischemia time, the cuff is deflated to confirm that the pulse has returned and has a reperfusion time of 5 minutes. A total of 4 cycles of 5 cycles of ischemic time and 5 minutes of reperfusion time are performed. (Estimated total 40 minutes) When the skull is started to close, RIpc with RIPostC group performs RpostC and the method is the same as the above RIPC method. (Estimated total 40 minutes)
15975220|NCT03072901|Device|EndoBarrier Gastrointestinal Liner|The EndoBarrier Gastrointestinal Liner (EndoBarrier) is a nonsurgical metabolic intervention for the treatment of Type 2 diabetes and obesity. By bypassing the duodenum and proximal jejunum, the device may alter signaling pathways that control metabolic processes.1, 2 The effect on patient's glucose levels is immediate as evidenced by meal tolerance testing.3 Since the device also promotes reduced appetite resulting in weight loss, the effect is maintained as the patient loses weight over the implant period. Most patients achieve normal HbA1c and fasting plasma glucose (FPG) levels rapidly within 3-6 months.
15975221|NCT03072888|Device|TENS|Transcutaneous Electrical Nerve Stimulation will be apply
15975222|NCT03072875|Device|CAMS-RAS|
15975223|NCT03072862|Device|Commercial Nucleus Cochlear Implant Systems|Commercially available Nucleus Cochlear Implant Systems, including Data Logging functionality
15975224|NCT03072849|Procedure|Pulmonary function testing|Each enrolled patient will receive pulmonary function testing every three months. Pulmonary function testing includes spirometry, plethysmography, and diffusion capacity measurements.
15975258|NCT03072615|Diagnostic Test|Stiffness measurement|Transient Elastopgraphy (TE) or Shear-Wave-Elastography
15975225|NCT03072849|Drug|FAM Therapy|All patients who have evidence of early airflow obstruction on pulmonary function testing will be started on FAM therapy. Early airflow obstruction is defined by a FEV1 decline of ≥10% predicted in addition to a FVC <0.8.
15975226|NCT03072836|Other|analysing microbiota|16SRNA gene sequencing of feces
15975227|NCT03072823|Dietary Supplement|n-3 Polyunsaturated fatty acid|2 g of Eicosapentaenoic acid (EPA) and 1 g of Docosahexaenoic acid (DHA)
15975228|NCT03072823|Dietary Supplement|placebo|olive oil ethyl esters
15975229|NCT03072810|Behavioral|Positive mindfulness program|4 week program consisting of 8 modules. Each module comprises an introduction video (approx. 10 minutes), a daily meditation (approx. 10 minutes) and a daily activity.
15975230|NCT03072784|Procedure|aortic cross clamping|duration of cross clamping, less than 90 minutes, or more than 90 minutes
15975231|NCT03072771|Drug|Blinatumomab|-Blinatumomab is a bispecific T cell engaging antibody
15975232|NCT03072771|Procedure|Autologous stem cell transplant|-Standard of care
15975233|NCT03072771|Drug|Carmustine|-Carmustine is an alkylating agent. It will be sourced from commercial supply. Institutional guidelines will be followed for storage, preparation, and administration of carmustine.
15975234|NCT03072771|Drug|Etoposide|-Etoposide is a semi-synthetic podophyllotoxin derivative. It will be sourced from commercial supply. Institutional guidelines will be followed for storage, preparation, and administration of etoposide.
15975235|NCT03072771|Drug|Cytarabine|-Cytarabine, commonly known as Ara-C, is a synthetic nucleoside. It will be sourced from commercial supply. Institutional guidelines will be followed for storage, preparation, and administration of cytarabine.
15975236|NCT03072771|Drug|Melphalan|-Melphalan is an alkylating agent. It will be sourced from commercial supply. Institutional guidelines will be followed for storage, preparation, and administration of melphalan.
15975237|NCT03072771|Procedure|Peripheral blood draws|-Day +42, Day + 43, Day +56, and Day +100
15975238|NCT03072758|Behavioral|Men's Club|"Interactive session: This will be a one-day five-hour session that will take place at the church, and will be facilitated by trained lactation nurses. This will involve a maximum of 10 male participants and will occur during the female partner's 3rd trimester. Male partners will (a) complete a structured questionnaire to determine baseline knowledge, attitudes and beliefs about breastfeeding practices, and (b) actively engage in educational information on the benefit of exclusive breastfeeding. At the end of the session, the participants will receive educational pamphlets on breastfeeding to reinforce all the information that had been provided.
~Phone call reminders: Participants will receive weekly robocalls during the first six weeks following the birth of the infant to reinforce the benefits of exclusive breastfeeding. This will be an automated service that will deliver the calls at a specific time of the day the participants have indicated on their questionnaire."
15975239|NCT03072745|Diagnostic Test|Neuropsychological assessment|Assessment with a neuropsychological test battery examining different aspects of memory and executive functioning
15975240|NCT03072732|Device|u-Cor System|Monitoring System
15975241|NCT03072732|Device|ZOE Fluid Status Monitor|Monitoring System
15975242|NCT03072719|Drug|Stannous Fluoride|Test dentifrice, participants will brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least one minute.
15975243|NCT03072719|Drug|Sodium Monofluorophosphate|Control dentifrice, participants will brush the whole mouth thoroughly for at least 1 minute.
15975244|NCT03072706|Device|Corin OPS™|The OPS Dynamic Hip Analysis is a computer software package used to generate simulations of a total joint replacement from patient imaging. The dynamic simulation is used for operative planning, including implant selection, sizing and placement; and to create custom instruments or delivery specifications referencing the patient's anatomy and bio-mechanics. The simulation can also be used for the post-operative evaluation of joint performance.
15975245|NCT03072706|Other|2D X-ray templating technology|Standard care where hip replacement is planned using 2D X-ray templating software
15975246|NCT03072693|Procedure|Home-based remote heart failure management|For patients randomized to Group 1, the home-based remote heart failure management system will be connected via the internet for active intervention. In Group 2 patients, the system will not be activated although all data will continue to be stored and reviewed at clinic visits. For patients in Group 1, clinically-assigned targets and alert thresholds of individual physiological parameters including blood pressure, pulse rate, and body weight will be decided before discharge and at entry into the three management modes. Site investigators will review individual patient physiological parameters upon clinic visits, and treatment can be initiated through instant communication (electronic communication and/or phone).
15975247|NCT03072693|Procedure|Home-based physiological parameter recording only|For patients randomized to Group 2, the home-based remote heart failure management system will continuously record and store patients information to be reviewed at clinic visits but not connected to internet. Site investigators will review individual patient physiological parameters upon clinic visits, and no treatment will be initiated through instant communication.
15975248|NCT03072680|Behavioral|BPS PAST|"Participants think about themselves in a past when they displayed their best self. Then, they visualize this with the help of audio instructions.
~They will practice within a mobile app."
15975249|NCT03072680|Behavioral|BPS FUT|"Participants think about themselves in the future after everything has gone as well as it possibly could. Then, they visualize this with the help of audio instructions.
~They will practice within a mobile app."
15975250|NCT03072680|Behavioral|DAILY ACTIVITIES|"Participants think about the activities they did during the last 24 hours. Then, they visualize this with the help of audio instructions.
~They will practice within a mobile app."
15975251|NCT03072667|Drug|Omegaven|Omegaven™ will be initiated at 0.5 gm fat/kg of body weight per day (5cc/kg per day of Omegaven™) for 2 days. On day 3, the rate of Omegaven™ will be increased to 1g/kg (10cc/kg) per day and will remain at this level thereafter unless otherwise indicated.
15975252|NCT03072654|Procedure|Thyroidectomy|Remove the nodular goiter on the neck by thyroidectomy (standard procedure)
15975253|NCT03072641|Dietary Supplement|ProBion Clinica|
15975254|NCT03072628|Other|e-cig with nicotine|use an e-cig with nicotine for 30 minutes
15975255|NCT03072628|Other|e-cig without nicotine|use an e-cig without nicotine for 30 minutes
15975256|NCT03072628|Other|nicotine inhaler|use a nicotine inhaler for 30 minutes
15975257|NCT03072628|Other|sham control|use an empty e-cigarette for 30 minutes
15975259|NCT03072602|Dietary Supplement|Study diet|Participants will consume the study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).
15975260|NCT03072602|Other|Glucose Challenge|Participants will come in fasting state on the main study visit day and will be given 75 gm oral glucose solution to drink, followed by blood collection every hour for next 8 hours.
15975261|NCT03072589|Drug|Regadenoson infusion|Dose escalation of Regadenoson when given as an infusion
15975262|NCT03072576|Device|Xpert MTB/RIF Ultra|Next generation Xpert MTB/RIF assay, this cartridge is intended for the detection of M. tuberculosis in sputum as well as the detection of M. tuberculosis mutations associated with resistance to rifampin
15975263|NCT03072550|Device|RenewalNail™ Plasma Treatment System|application of cold atmospheric plasma to a fungal infected toenail
15975264|NCT03072524|Diagnostic Test|FAST PLUS test|FAST PLUS test consists of two parts: the first one is the standard FAST test, which evaluates Speech (0-1), Facial palsy (0-1), Arm motor function (0-1), Time (0-1). The second part of the FAST PLUS test evaluates only the presence of severe arm or leg motor deficit (0-1), and unilateral occurrence of this motor function deficit (0-1).
15975265|NCT03072511|Behavioral|Spotlight on Smoke-Free Living: Mindsets and Decisions|Intervention will consist of elements to help quit smoking. All intervention elements will be informed by Construal Level Theory.
15975266|NCT03072511|Drug|Transdermal Nicotine Patch|TNP serve as nicotine replacement for individuals who are attempting to stop smoking. They are safe for use and dosing will be determined for each participant based off of manufacturer's recommendations.
15975267|NCT03072485|Drug|Sirolimus|Topical sirolimus applied to the skin
15975268|NCT03072485|Drug|Metformin|Topical metformin applied to the skin
15975269|NCT03072485|Drug|Diclofenac|Topical diclofenac applied to the skin
15975270|NCT03072472|Device|Endocuff Vision|The EndocuffTM (ARC Medical Design Ltd and Diagmed, UK) is a device (CE marked in UK) made of a soft plastic material with a unique dynamic shape. Endocuff Vision™ is placed snugly around the colonoscope tip prior to insertion. It does not project beyond the tip of the scope, providing an unrestricted view. It helps anchor the scope tip against the bowel wall to provide a stable platform of access. The soft, elastic projections are pushed back (recoiled) towards the scope shaft during insertion but evert during withdrawal to hold colon folds away from the field of view.
15975271|NCT03072446|Device|Gel-Beads embolic material|Patients will receive embolization of their uterine fibroids using Gel-Beads.
15975272|NCT03072433|Behavioral|Counseling Intervention Package|Daily 45 minutes of group teaching for primary caregivers, followed by 45 minutes of supervised play and stimulation with their children for a total of four days. Teaching modules consist of psychosocial stimulation, nutrition and feeding, and water, sanitation and hygiene practices.
15975273|NCT03072433|Behavioral|Standard of Care|Nutrition and water sanitation and hygiene counseling at any point prior to discharge from hospital as per the local nutrition rehabilitation unit standard of care. In addition, primary caregivers will be stimulated to play with their children in a play area.
15975274|NCT03072420|Other|Compression of the fingertip under MRI.|Compression of the fingertip by a static loading on the phalanx distal of the index of the subjects; Then also a shear stress in the transverse direction of the finger. The data provided by the MRI images will be geometric information such as the thickness of the skin and its possible variation as a function of the area of the finger, the total thickness of soft tissues in compression as a function of the variation in l The angle between the axis of the phalanx and the plane of contact; Mechanical type information relating to the displacements and reaction forces, to the internal deformations of the different areas of the finger.
15975275|NCT03072407|Biological|PB-119 injection|
15975276|NCT03072407|Biological|PB-119 injection placebo|
15975277|NCT03072394|Drug|Local anesthetic|Local skin anesthesia during radial coronary artery catheterization by EMLA anesthetic ointment
15975278|NCT03072394|Drug|local anaesthetic injection|Local skin anesthesia during radial coronary artery catheterization by lidocaine injection
15975279|NCT03072381|Biological|Platelet Rich Plasma - Group 1|Subjects in Group 1 (PRP) will receive a single ultrasound-guided intratendinous (common extensor tendon origin) injection of up to 3 mL autologous PEAK platelet-rich plasma at week 0 (baseline).
15975280|NCT03072381|Drug|Corticosteroid Control - Group 2|Subjects in Group 2 (corticosteroid control) will receive a single ultrasound-guided intratendinous injection approximately (may be limited by tendon/soft tissue limitations of the subject) of 2 mL 1% lidocaine + 1mL of him 40mg Kenalog (triamcinolone hexacetonide, 40mg/mL) at week 0.
15975281|NCT03072368|Other|Photograph|Babies will be photographed and eye color will be observed and documented at birth, 3 months and one year of age
15975282|NCT03072355|Other|Elastic Band|Localized muscle resistance test for shoulder
15975283|NCT03072355|Other|Isokinetic dynamometer|Localized muscle resistance test for shoulder
15975284|NCT03072342|Procedure|Intensive Periodontal Treatment|
15975285|NCT03072342|Procedure|Control Periodontal Treatment|
15975286|NCT03072329|Procedure|Pudendal nerve block|
15975287|NCT03072329|Drug|Bupivacaine|
15975288|NCT03072316|Other|3D surface imaging|3D photography
15975289|NCT03072316|Other|semi-structured interview|qualitative analysis using semi structured interview
15975290|NCT03072316|Other|applanation tonometry|measurement of breast compressibility
15975291|NCT03072303|Other|Web-based Survey|Patients will be sent an email invitation describing the study. If the participant wants to participate and is eligible, she will follow the survey link in the email message, which directs her to an IRB-approved online consent form. A unique survey link will be generated for each participant and included in the survey invitation, which is a customized email message. This link will allow the investigators to determine who completed the survey. The investigators will send repeat email invitations every two months (total of 3 invitations) to those invitees who have not yet participated. The investigators will allow approximately 6 months for enrollment and survey completion and expect that the study will close soon thereafter.
15975292|NCT03072290|Drug|Triamcinolone Acetonide|ultrasound-guided injection using 1ml of 10 mg (10mg/ml) or 40 mg (40 mg/ml) triamcinolone acetonide (Shincort)
15975293|NCT03072290|Drug|lidocaine hydrochloride|ultrasound-guided injection using 1 ml of 2% lidocaine hydrochloride (Xylocaine)
15975415|NCT03071380|Drug|Repatoxaban|1 tablet contains 10 mg rivaroxaban
15975416|NCT03071380|Drug|Xarelto|1 tablet contains 10 mg rivaroxaban
15975294|NCT03072277|Dietary Supplement|Docosa Hexaenoic Acid (DHA)|400 mg/day of Docosa-hexaenoic Acid (algal DHA) will given to the pregnant women (in the active group) from ≤20 weeks of gestation through 6 months postpartum.
15975295|NCT03072277|Dietary Supplement|Placebo|400 mg/day of placebo (corn/soy oil) will be given to the pregnant women from ≤20 weeks of gestation through 6 months postpartum.
15975296|NCT03072264|Behavioral|Body in Mind Training (BMT)|Session 1 - Stop; Session 2 - Intention; Session 3 - Attention; Session 4 - Scientist Myself; Session 5 - Self-Compassion; Sessions 6, 7, 8 - Practice.
15975297|NCT03072264|Drug|Fluoxetine|In this group, individuals will consult with a psychiatrist weekly and will receive fluoxetine in a dosage of 20 to 60mg/dia according to clinical response.
15975298|NCT03072264|Behavioral|Quality of Life Group|Session 1 - Psychoeducation; Session 2 - Substance Use; Session 3 - Sleep; Session 4 - Physical Exercise; Session 5 - Healthy Eating; Sessions 6, 7,8 - discussions.
15975299|NCT03072238|Drug|Ipatasertib|Oral tablets, 400 mg, given once daily (QD) beginning on Day 1 of Cycle 1 until disease progression or intolerable toxicity.
15975300|NCT03072238|Drug|Abiraterone|Oral tablets of abiraterone, 1000 mg QD, taken on an empty stomach and swallowed whole with water.
15975301|NCT03072238|Drug|Placebo|Oral tablets (matched to ipatasertib appearance), given QD beginning on Day 1 of Cycle 1 until disease progression or intolerable toxicity.
15975302|NCT03072238|Drug|Prednisone/Prednisolone|Oral tablets of 5 mg, taken twice daily (BID) until disease progression or intolerable toxicity.
15975303|NCT03072225|Drug|Herbal Medicine C-117|Herbal Medicine C-117 formula including 2 herbals and 2 insects
15975304|NCT03072225|Drug|The Placebo of Herbal Medicine C-117|The Placebo of Herbal Medicine C-117 formula including 4 herbals
15975305|NCT03072212|Other|Observational study|No intervention
15975306|NCT03072199|Drug|RiTUXimab Injection|Single dose of Rituximab given intravenously within 48hours of myocardial infarction
15975307|NCT03072186|Device|near-infrared light nasal endoscope used with ICG|Using the near-infrared light nasal endoscope with ICG will identify anatomical landmarks and and tumor characteristics to provide a clear demonstration of the blood supply.
15975308|NCT03072173|Drug|Xylometazoline|Patient will be given a nasal decongestant (Xylometazoline) prior to their 2nd or 3rd night of PSG.
15975309|NCT03072173|Drug|placebo (saline)|Patient will be given a placebo nasal spray (saline) prior to their 2nd or 3rd night of PSG.
15975310|NCT03072160|Drug|Pembrolizumab|Pembrolizumab 200 mg will be administered as a 30 minute intravenous (IV) infusion every 3 weeks.
15975311|NCT03072147|Drug|Teriparatide|20 mcg of teriparatide injected in thigh or abdomen once a day for 24 weeks.
15975312|NCT03072147|Drug|Placebo|20 mcg of saline injected in thigh or abdomen once a day for 24 weeks.
15975313|NCT03072134|Biological|Neural stem cells loaded with an oncolytic adenovirus|The primary objectives are to evaluate the safety of the combined therapy and determine the maximum tolerated dose (MTD) for a future Phase II study.
15975314|NCT03072121|Drug|Shexiang Baoxin pill|Conventional western medicine & shexiang baoxin pill
15975315|NCT03072121|Drug|SBP placebo|Conventional western medicine & placebo (for shexiang baoxin pill)
15975316|NCT03072121|Drug|Aspirin Enteric-coated Tablets|100mg tablet, one tablet daily.
15975317|NCT03072121|Drug|Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet|one tablet daily. (for patients who can't use aspirin)
15975318|NCT03072121|Drug|Atorvastatin Calcium|10 mg tablet, two tablets each night.
15975319|NCT03072121|Drug|Isosorbide Mononitrate Tab 20 MG|1 tablet two times daily.
15975320|NCT03072121|Drug|Metoprolol Tartrate Tab 25 MG|12.5 mg or 25 mg two times daily.
15975321|NCT03072121|Drug|Trimetazidine Dihydrochloride Tablets|20 mg tablet, one tablet three times daily.
15975322|NCT03072108|Dietary Supplement|Bonolive|2 caps per day of Bonolive
15975323|NCT03072108|Dietary Supplement|Placebo|2 caps per day of Placebo
15975324|NCT03072095|Behavioral|Text-only|Subjects will receive a text communication indicating they are overdue for colon cancer screening with the option to elect to receive a free, at-home FIT kit.
15975325|NCT03072095|Behavioral|Text + Lottery|Subjects will receive a text communication indicating they are overdue for colon cancer screening with the option to elect to receive a free, at-home FIT kit and a 1 in 5 chance to win a $100 gift card for completing the kit.
15975326|NCT03072082|Drug|Danlou Tablet|Conventional western medicine & Danlou Tablet
15975327|NCT03072082|Drug|DanLou Tablet placebo|Conventional western medicine & placebo (for Danlou Tablet)
15975328|NCT03072082|Drug|Aspirin Enteric-coated Tablets|100 mg tablet, one tablet daily.
15975329|NCT03072082|Drug|Clopidogrel Hydrogen Sulfate 75 MG Oral Tablet|One tablet daily. (for patients who can't use aspirin)
15975330|NCT03072082|Drug|Atorvastatin calcium|10 mg tablet, two tablets each night.
15975331|NCT03072082|Drug|Isosorbide Mononitrate Tab 20 MG|One tablet two times daily.
15975332|NCT03072082|Drug|Metoprolol Tartrate Tab 25 MG|12.5 mg or 25 mg two times daily.
15975333|NCT03072082|Drug|Trimetazidine Dihydrochloride Tablets|20 mg tablet, one tablet three times daily.
15975334|NCT03072056|Drug|MIN-101|
15975335|NCT03072043|Drug|APR-246|Phase 1b: Dose escalation of APR-246 via intravenous (IV) infusion, with starting dose of 50 mg/kg lean body weight (LBW). Phase 2: APR-246 at maximum tolerated dose (MTD).
15975336|NCT03072043|Drug|Azacitidine|Azacitidine is administered subcutaneously (SC) or via IV at 75 mg/m^2.
15975337|NCT03072030|Biological|GamEvac-Combi (vaccine)|vaccination
15975338|NCT03072030|Biological|Placebo|vaccination
15975339|NCT03072017|Behavioral|MBAT|Breathing-based intervention
15975340|NCT03072004|Device|LLLT|The LLLT will be applied using a diode laser device (Recover Laser MMOptics, São Carlos/SP- Brazil) with parameters: 808nm, continuous output, 100mW, 8J. Laser probe will be applied directly and perpendicularly in skin contact (5 points), the time of irradiation will be 80 seconds per point, and treatments will be applied for three times a week for 12 sessions.
15975341|NCT03072004|Device|Sham LLLT|"That group receive application sham LLLT. The laser will be turned off, but the procedure will be the same as with the LLLT group"
15975342|NCT03071991|Procedure|study group|local anesthetic drug will be used
15975343|NCT03071991|Procedure|control group|no local anesthetic drug will be used
15975417|NCT03071367|Other|Clinical Simulation|
15975344|NCT03071978|Device|CRT with LV-only pacing / bi-ventricular pacing|LV-fusion pacing group received cardiac resynchronization therapy with adaptive algorithm and disabled RV pacing. While BV pacing group received conventional cardiac resynchronization therapy without adaptive algorithm.
15975345|NCT03071965|Biological|Ciliary neurotrophic factor (CNTF)|The investigational product is the NT-501 encapsulated cell system, which consists of cells encapsulated within a semi-permeable polymer membrane and supportive matrices. NT-501 contains NTC-201 cells that secrete recombinant human CNTF, which were derived from genetically modified NTC-200 cells.
15975346|NCT03071965|Procedure|Surgery|Surgery to implant device for NT-501
15975347|NCT03071965|Procedure|Surgery|Sham surgery
15975348|NCT03071939|Other|Assessment of the insight of schizophrenic patients by themselves, their relatives and caregivers|"This study will evaluate the insight of the patient, something carried out in common practice within the Eastern Pole (CH Le Vinatier). This assessment will take place in the specific services where patients are cared for. It will make it possible to evaluate insight more closely by comparing the opinions of the three actors. There is no risk in this study.
~The study will be carried out over 2 years with a recruitment of 119 patients responding to the diagnosis of schizophrenia, taken care of within the Eastern Pole (Intra and Extrahospital services)."
15975349|NCT03071926|Drug|Pegylated Liposomal Doxorubicin|20 mg, qw, first 6 weeks ,every 8 weeks
15975350|NCT03071913|Procedure|Biospecimen Collection|Undergo collection of tissue and blood samples
15975351|NCT03071913|Other|Laboratory Biomarker Analysis|Correlative studies
15975352|NCT03071900|Diagnostic Test|circulating tumor cell analysis|Detect circulating tumor cells with CellCollector in SCCHN and control group.
15975353|NCT03071887|Behavioral|Relaxation Response Resiliency Program (3RP)|The 3RP blends stress management principles, cognitive behavioral therapy, and positive psychology. The 3RP focuses on 3 major areas: (1) eliciting the relaxation response; (2) increasing stress awareness; and (3) promoting adaptive strategies. The 3RP intervention currently consists of eight, 90-minute weekly group sessions. The investigators plan to adapt the intervention to address common concerns for older, HIV-infected women, including: stress of managing a chronic long-term, life threatening illness; additional medical comorbidities; pain and fatigue; stigma and social isolation; depression and anxiety; and sexuality concerns.
15975354|NCT03071874|Drug|AZD2014|AZD2014 is a dual mTORC1/mTORC2 inhibitor
15975355|NCT03071861|Drug|Darbepoetin Alfa|Single dose of 10 mcg/kg Darbepoetin Alpha given IV at less than 24 hours of age
15975356|NCT03071861|Drug|Normal Saline|Single dose of normal saline, IV, given at less than 24 hours of age
15975357|NCT03071848|Other|No Intervention|This was an observational study.
15975358|NCT03071822|Drug|cisplatin|PIGLETs
15975359|NCT03071822|Drug|ifosfamide|PIGLETs
15975360|NCT03071822|Drug|gemcitabine|PIGLETs
15975361|NCT03071822|Drug|L-asparaginase|PIGLETs
15975362|NCT03071822|Drug|etoposide|PIGLETs
15975363|NCT03071822|Drug|dexamethasone|PIGLETs
15975364|NCT03071796|Dietary Supplement|multivitamin supplement|supplement includes 97 natural extracts
15975365|NCT03071796|Dietary Supplement|Placebo|liquids with similar appearance and taste like multivitamin supplement for 12 weeks
15975366|NCT03071783|Device|Vacuum extraction intelligent system|Vacuum extraction intelligent system - this is the intervention
15975367|NCT03071770|Drug|ivosidenib (AG-120)|A single-dose of ivosidenib (AG-120) administered in healthy Japanese and Caucasian subjects
15975368|NCT03071757|Drug|ABBV-368|Intravenous infusion
15975369|NCT03071757|Drug|ABBV-181|Intravenous infusion
15975370|NCT03071744|Drug|Lazanda|Lazanda is supplied in glass bottles, containing 8 sprays of 100 mcL containing 100 mcg/100 mcL or 400 mcg/100 mcL concentration solution.
15975371|NCT03071731|Drug|Bronchodilators|Administration of a nebulized combination of bronchodilators before the administration of a functional test.
15975372|NCT03071731|Drug|Placebos|Administration of a nebulized placebo before the administration of a functional test
15975373|NCT03071718|Other|Mediterranean diet|"Subjects in the Med-D group will be assigned a personalized diet prepared on the basis of own eating habits as established by 7-d food diary recalls. Energy values of habitual diets will be kept unchanged during Med-D intervention. Briefly, Med-D will be prepared so as to achieve a weekly consumption of:
~7 portions of milk or yogurt plus whole grain cereals,
~7 portions of nuts (30g)
~At least 3 portion of absolute legumes
~14 portions of vegetables
~21 portions of fruit
~4 portions of whole grain pasta
~3 portions of whole grain pasta with vegetables or legumes
~7 portions of whole grain bread
~3 portions of fish
~Extravirgin olive oil as unique source of discretional fats All subjects will be requested not to change physical activity levels during the 8 week intervention period."
15975374|NCT03071718|Other|Control Diet|Control subjects will not change their habitual diet during intervention. All subjects will be requested not to change physical activity levels during the 8 week intervention period.
15975375|NCT03071705|Drug|Metformin|500 mg PO BID
15975376|NCT03071705|Drug|TKI|standard dose
15975377|NCT03071692|Drug|K-877|0.2mg tablet
15975378|NCT03071692|Drug|Placebo|K-877 matching placebo tablet
15975379|NCT03071679|Drug|Omiganan|Omignan 1%, 2.5%
15975380|NCT03071679|Drug|Imiquimod|Imiquimod 15mg
15975381|NCT03071679|Drug|Omiganan 1% and Imiquimod|Omiganan 1% and Imiquimod
15975382|NCT03071679|Drug|Omiganan 2.5% and Imiquimod|Omiganan 2.5% and Imiquimod
15975383|NCT03071679|Drug|Placebo|Vehicle
15975384|NCT03071666|Dietary Supplement|cobalamin|Vitamin supplment tablet containing 50µg cobalamin
15975385|NCT03071666|Dietary Supplement|placebo|A tablet identical to the vitamin supplement but containing no vitamin B12
15975386|NCT03071653|Procedure|Left Cardiac Sympathetic Denervation (LCSD)|The procedure involves the surgical removal of the lower half of the left stellate ganglion (T1) and thoracic ganglia (T2-T4), thereby removing the pro-arrhythmic noradrenergic input to the ventricles
15975418|NCT03071354|Dietary Supplement|HMB protein supplement (3g)|HMB 3g/day or iso-nitrogenous control (discussed below) in addition to standard enteral, and parenteral nutritional supplementation and standard nutrition when transferred to the ward. The dose of HMB was chosen based on multiple studies revealing efficacy of 3g/day improving muscle mass and demonstrating an excellent safety profile. Feeding will be initiated as per local practice. Enrolled patients will be randomized to supplementation with HMB (3g) or control will begin within 72 hours of admission to ICU.
15975387|NCT03071653|Other|Optimal Medical Therapy|"All eligible patients with heart failure and depressed left ventricular systolic function will receive guideline and evidence based optimal tolerated medical therapy. The level of risk associated with optimal medical therapy is considered very low. For the majority of patients with heart failure and depressed left ventricular systolic function this will include:
~A renin angiotensin system blocker at highest tolerated doses (e.g., enalapril 10mg twice daily or equivalent)
~A mineralocorticoid receptor antagonist (e.g., Spironolactone 25-50mg daily or equivalent)
~A Beta-blocker (e.g., Carvedilol 25mg twice daily or equivalent)
~The use of a loop diuretic and digitalis will be clinically driven and used at the discretion of the attending clinician"
15975388|NCT03071627|Other|New items with spin|Interpretation of news items with spin
15975389|NCT03071627|Other|New items without spin|Interpretation of news items without spin
15975390|NCT03071614|Other|News items with spin|Interpretation of news items with spin
15975391|NCT03071614|Other|News items without spin|Interpretation of news items without spin
15975392|NCT03071601|Drug|Lidocaine-Prilocaine Cream 2.5-2.5%|Topical anesthesia using a cream containing 2.5% Lidocaine and 2.5 % Prilocaine for at least 30 minutes on and around the wound before suture
15975393|NCT03071601|Drug|Lidocaine 1% Epinephrine 0.005mg/mL solution|Local anesthesia by subcutaneous injection of a solution containing 1% Lidocaine and 0.005mg/mL Epinephrine in and around the wound in the minutes preceding the suture of the wound
15975394|NCT03071588|Device|Mechanical rotary burs|A rotary drill made of steel or diamond impregnated materials attached to a steel shank, available in varying degree of sharpness, lengths and sizes used conventionally in preparation of teeth to receive a dental restoration.
15975395|NCT03071588|Device|Carisolv gel|A chemical gel made of a combination of amino acids and sodium hypochlorite used with hand instruments to soften and remove the decay to prepare the tooth to receive a dental restoration.
15975396|NCT03071575|Biological|Measles-rubella (MR) vaccine at 6 and 9 months|Arm A will receive MR vaccine dose at 6 and 9 months of age
15975397|NCT03071575|Biological|Measles-rubella (MR) vaccine at 9 months|Arm A will receive MR vaccine dose at 9 months of age
15975398|NCT03071562|Other|Yoga-mindfulness|"Sample class:
~Warm-up
~(15 minutes) Standing poses
~(15 minutes) Balance poses
~(15 minutes) Abdominals & back bends (10 minutes) Cool-down
~(5 minutes) Seated meditation Alternate nostril breathing Bellows breath Shoulder/neck stretches Cat-cow Forward fold Sun salutations Warrior 1 Warrior 2 Triangle Extended side angle Reverse warrior High lunge with twist Tree pose Standing holding knee Modified warrior 3 (chair support) Half moon
~Bird-dog Side plank Bridge Cobra Sphinx Corpse pose Side-lying Seated om
~Every month, a smudging ceremony will take place with an Aboriginal Elder for 5-10 minutes at the start of the class."
15975399|NCT03071549|Drug|Trichloroacetic acid peel|Skin degreasing will be performed before every session using acetone. Trichloroacetic acid 25% will be applied on one side of the face.
15975400|NCT03071549|Drug|combined azaleic and salicylic acids|Skin degreasing will be performed before every session using acetone. Azaleic acid 20% with salicylic acid 20% will be applied to the other side of the face.
15975401|NCT03071536|Drug|Furosemide Injection|Furosemide 1.5 mg/kg intravenously at 3 hours post-reperfusion of kidney allograft
15975402|NCT03071523|Procedure|coronally advanced lingual flap|Full-thickness crestal incision will be made over the edentulous ridge followed by one full-thickness vertical incision on the buccal side. On the buccal side, full thickness mucoperiosteal flap will be raised with horizontal incision 1-3 mm in depth performed in the buccal flap. On the lingual side, a full-thickness mucoperiosteal flap will be elevated until reaching the mylohyoid line. A band of mylohyoid muscle is inserted into the inner part of the lingual flap approximately 5 mm from the crest in an apical direction. A blunt instrument will be inserted below that connective band, and, with gentle traction in the coronal direction, this muscular insertion should be detached freeing the lingual flap from the mylohyoid.
15975403|NCT03071523|Procedure|periosteal releasing incision|Full-thickness crestal incision will be made over the edentulous ridge followed by one full-thickness vertical incision on the buccal side and a full thickness flap will be raised. Xenograft and Ti-mesh will be used to augment the defective site then incremental incisions of 1-3 mm into the periosteum and submucosa will be used to advance the muco-periosteal flap. The flap will then be sutured with interrupted sutures.
15975404|NCT03071510|Device|Atlas Genetics io® system|Specimen Collection
15975405|NCT03071497|Diagnostic Test|Non-invasive analysis of Zinc protoporphyrin|In patients fitting the inclusion criteria Zinc protoporphyrin will be measured non-invasively as proxy for iron deficiency. Results will be compared to ZnPP reference values measured via HPLC and with spectroscopical measurements performed on whole blood as well as with blood values (HB, MCH, MCV, ferritin, CRP, transferrin saturation, soluble transferrin receptor) assessed during clinical routine.
15975406|NCT03071484|Device|Transcranial Direct Current Stimulation|The tDCS is a non-invasive neuromodulatory technique that delivers low-intensity, direct current to cortical areas facilitating or inhibiting spontaneous neuronal activity.
15975407|NCT03071471|Device|MID-C|"The MID-C system is designed to correct the deformity step by step along a period of time, giving the skeletal and soft tissues accommodate any incremental correction.
~The MID-C System inherent benefits are:
~Only two screws are used
~Incision size is much smaller
~Simpler operation with shorter operative time
~Less complication thanks to the three points above.
~Minimal spinal mobility loss"
15975408|NCT03071432|Diagnostic Test|Paced breathing at 6, 10 and 15 breaths per minute|
15975409|NCT03071419|Behavioral|Nutrition and Parenting Intervention|The proposed intervention will evaluate and explore the unique influences that low-income fathers have on their preschool age children's obesogenic behaviors and obesity risk.
15975410|NCT03071406|Drug|Nivolumab|Nivolumab 240 mg/dose intravenously (IV) every 2 (q2) weeks.
15975411|NCT03071406|Drug|Ipilimumab|Ipilimumab 1 mg/kg/dose IV q6 weeks.
15975412|NCT03071406|Radiation|Stereotactic Body Radiation Therapy (SBRT)|Stereotactic Body Radiation Therapy 24Gy in 3 fractions.
15975413|NCT03071393|Device|Hypoxico Hyp-123|During acute intermittent hypoxia, subjects will undergo 15 brief exposures (60-120 seconds) of low oxygen air (9-15% inspired oxygen) delivered by an air generator, alternated with 15 brief exposures (60-120 seconds) of ambient room air.
15975414|NCT03071393|Device|Hypoxico Hyp-123|During sham intermittent hypoxia, subjects will undergo 15 brief exposures (60-120 seconds) of normal oxygen air (21% inspired oxygen) delivered by an air generator, alternated with 15 brief exposures (60-120 seconds) of ambient room air.
15975419|NCT03071354|Dietary Supplement|Nutritional Supplement|Control patients will receive 2 x 237mL bottles of the commercially available nutritional supplement (Ensure® Original) in addition to standard enteral, and parenteral nutritional supplementation and standard nutrition when transferred to the ward throughout the study. While the patient is intubated, the control nutritional supplement will be delivered via the enteral feeding tube. The participant will switch to oral administration once extubated
15975420|NCT03071341|Drug|AGT-181|Human Insulin Receptor Monoclonal Antibody-Human alpha-L-iduronidase (HIRMAb-IDUA) Fusion Protein
15975421|NCT03071328|Drug|Isovue-M 200|Diluted iodinated contrast will be injected under CT fluoroscopy guidance into bone, lymph node, soft tissue, or liver metastases in subjects with metastatic castrate resistant prostate cancer, metastatic urothelial carcinoma or metastatic renal cell carcinoma and pre and post-injection CT images will be obtained to characterize the parameters needed for optimal distribution throughout metastases of a given size. To validate the expression of CD155 in prostate cancer, a biopsy of the metastatic site will be obtained at the time of contrast injection and will be stained for CD155 expression.
15975422|NCT03071315|Other|CCT|CCT focuses on behavioral approach, mainly punitive punishment measures.
15975423|NCT03071315|Other|MMT|MMT is a combination of pharmaceutical and behavioral intervention.
15975424|NCT03071302|Other|EVALUATION OF VSX1, SOD1, and TIMP3 genes|Evaluation of VISX1, SOD1, TIMP3 genes in corneal epithelium, and in peripheral blood. Evaluation of pentacam parameters
15975425|NCT03071289|Radiation|Radiation Method B|The gross tumor volume (GTV) is the residual lesion after radical resection and given a dose of 60Gy. The clinical target volume (CTV) is delineated according to the lymph drainage pathway and included all the lymphocyst. The CTV is given a dose of 45Gy.
15975426|NCT03071289|Drug|Cisplatin|The regimen of chemotherapy is cisplatin 30mg/m2 every week.
15975427|NCT03071289|Radiation|Radiation Method A|The gross tumor volume (GTV) is the residual lesion after radical resection and given a dose of 60Gy. The clinical target volume (CTV) is delineated according to the lymph drainage pathway and given a dose of 45Gy.
15975428|NCT03071276|Drug|Selinexor|Given orally on days 1,3,8,10,22 and 24 of each cycle
15975429|NCT03071276|Drug|Fludarabine|Will be given intravenously (IV) over 30 minutes daily on days 16 through 20. Fludarabine may be given prior to day 16 if it is determined to be in the participant's best interest based on disease progression. Chemotherapy may be delayed by 1-3 days if clinically indicated.
15975430|NCT03071276|Drug|Cytarabine|Will be given IV over 4 hours daily on days 16 through 20. Cytarabine may be given prior to day 16 if it is determined to be in the participant's best interest based on disease progression. Chemotherapy may be delayed by 1-3 days if clinically indicated.
15975431|NCT03071276|Drug|methotrexate/hydrocortisone/cytarabine|Intrathecal (IT) triples will be given prior to cycle 1: IT cytarabine, IT methotrexate, and IT methotrexate/hydrocortisone/cytarabine (MHA) are acceptable. Patients without evidence of central nervous system (CNS) leukemia will receive no further IT therapy during cycle 1. Patients with CNS disease will receive weekly ITMHA until the cerebrospinal fluid becomes free of leukemia (minimum of 4 doses).
15975432|NCT03071263|Drug|Patiromer|2 packets/day starting dose, administered orally
15975433|NCT03071263|Drug|Placebo|2 packets/day starting dose, administered orally
15975434|NCT03071263|Drug|Spironolactone|25 mg tablet/day starting dose, administered orally
15975435|NCT03071250|Procedure|Total knee or Hip Arthroplasty|Patients who received either a total knee or hip arthroplasty will be identified
15975436|NCT03071237|Procedure|Gastrectomy|Patients with gastric cancer that needs receiving total or distal gastrectomy. During the surgery, IPA needs to be exposed and transected.
15975437|NCT03071224|Drug|[18F] MNI-946|Subjects will undergo PET imaging using [18F]MNI-946, a PET radioligand for imaging tau.
15975438|NCT03071224|Drug|[18F]Florbetapir|Subjects with Alzheimer's disease will receive a [18F]florbetapir scan to compare distribution of tau in the brain compared to that of [18F]MNI-946.
15975439|NCT03071211|Device|Plug-unplug catheter management|Transurethral catheter is plugged with a plastic cap and participants are taught to unplug during the day when they feel the urge to void or at least every 4 hours.
15975440|NCT03071211|Device|Continuous drainage catheter management|Transurethral catheter is attached to a continuous drainage bag.
15975441|NCT03071198|Procedure|TME|"Find the hypogastric nerve trunk in front of sacral promontory and protect it,be careful to use electrocautery hemostasis biased toward the side of rectal when handle lateral ligament of rectum and middle rectal artery and avoid to damage the pelvic plexus.
~At least a 2-cm margin to the lower edge of the tumor is adequate for distal bowel resection. Resect 5cm length distal rectal or all of the mesorectum.Check the integrity of the mesorectum in postoperative routine examination. Double stapling method is used for all low anastomosis operations."
15975442|NCT03071198|Radiation|Concurrent chemo-radiotherapy|Three-dimensional conformal radiotherapy as following: CTV 44Gy/22 times＋GTV1 6Gy/3 times(2Gy/time/day，5 days a week，totally 5 weeks),if rectal tumors do not regress obviously, additional GTV2 is necessary, 5.4Gy/3 times (1.8Gy/time/day). At the same time, Capecitabine (850mg/m2, two times every day) will be taken on radiotherapy day
15975443|NCT03071198|Drug|neoadjuvant CT|CAPEOX protocol:Oxaliplatin 130mg/m2 ivgtt 2-6h dl;(Capecitabine 1000mg/m2 2 times a day lasts for 14 days Repeat every 3 weeks
15975444|NCT03071198|Drug|adjuvant CT|CAPEOX protocol:Oxaliplatin 130mg/m2 ivgtt 2-6h dl;(Capecitabine 1000mg/m2 2 times a day lasts for 14 days Repeat every 3 weeks
15975445|NCT03071185|Procedure|femoral nerve block, common peroneal nerve block|For patients with fibular flaps harvested, femoral nerve block and common peroneal nerve with ropivacaine were administered. For patients with ALT flaps harvested, femoral nerve block with ropivacaine was administered.
15975446|NCT03071172|Drug|Triptorelin for Injection|Drugs for IVF-ET (in vitro fertilization and embryo transfer).
15975447|NCT03071172|Drug|Recombinant Human Choriogonadotropin alfa Solution for Injection|Drugs for IVF-ET (in vitro fertilization and embryo transfer).
15975448|NCT03071172|Drug|Progesterone Soft Capsules|Drugs for IVF-ET (in vitro fertilization and embryo transfer).
15975449|NCT03071159|Device|FreeStyle Flash Libre glucose monitoring system|glucose monitoring system with sensors
15975489|NCT03070860|Radiation|PET scan 18-FDG and 18-NAF|"Positron emission tomography (PET) is a medical imaging test performed in a nuclear medicine department.
~PET scan is performed by IV injection of a mildly radioactive tracer (NAF and FDG)."
15975490|NCT03070847|Drug|Tranexamic Acid|Dose: 5mg/kg
15975450|NCT03071146|Device|Bard® LifeStent® 5F Vascular Stent System|The LifeStent® Vascular Stent is a peripheral stent intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (SFA) and popliteal artery with reference vessel diameters ranging from 4.0 - 6.5 mm.
15975451|NCT03071120|Behavioral|Parent-Mediated Intervention|Children with ASD will participate in a 6-month parent-mediated intervention that will include direct intervention and parent education.
15975452|NCT03071107|Behavioral|Multi-disciplinary intervention|Participants in the intervention group will receive a multifactorial, interdisciplinary, treatment program intended to target pre-frailty for a 4-month period following randomization (physical meetings at 2-monthly time points with telephone consultations between meetings). The interventions will be individually tailored to each participant based on their frailty characteristics at baseline and amended if other problems are identified during the intervention program. This intervention team will consist of a renal dietitian and physiotherapist, both of whom will be trained and accredited in behavioural therapy intervention skills, and will focus on improving nutritional status and physical strength through resistance exercise training. They will be supported by a Clinical Research Fellow who will provide additional medical assessment to determine any reversible medical causes of frailty.
15975453|NCT03071094|Biological|Pexastimogene Devacirepvec (Pexa Vec)|Pexa-Vec (pexastimogene devacirepvec) will be administered as 3 bi-weekly intratumoral (IT) injections of 10^9 pfu at day 1 and weeks 2 and 4
15975454|NCT03071094|Drug|Nivolumab|Nivolumab will be administered intravenously every 2 weeks (from week 2)
15975455|NCT03071081|Drug|TOP1288|Oral TOP1288
15975456|NCT03071081|Drug|Placebo to TOP1288|Oral placebo to TOP1288
15975457|NCT03071068|Drug|Anti-PlGF recombinant monoclonal antibody, 4mg dose|3 intravitreal injections of THR-317 4mg approximately 1 month apart
15975458|NCT03071068|Drug|Anti-PlGF recombinant monoclonal antibody, 8mg dose|3 intravitreal injections of THR-317 8mg approximately 1 month apart
15975459|NCT03071055|Drug|Ranibizumab Injection [Lucentis]|intravitreal injection
15975460|NCT03071042|Drug|Apatinib|Apatinib Mesylate Tablets 425mg (500mg，675mg or 750mg) po. qd continuous;
15975461|NCT03071042|Drug|Docetaxel|Docetaxel 60mg/m2 ivgtt day 1, q21d Combined use of Docetaxel and Apatinib
15975462|NCT03071029|Behavioral|Monthly PAFP rates displayed at clinics.|Providers will receive visual and text feedback on their centre's PAFP uptake rates as they compare to the uptake rates of other centres. The feedback will be delivered monthly in a physical paper format.
15975463|NCT03071003|Drug|SENS-401|Oral Administration
15975464|NCT03071003|Drug|Placebo|Oral Administration
15975465|NCT03070990|Drug|Enfortumab vedotin|All subjects assigned will receive a single 30 minute intravenous infusion of enfortumab vedotin (ASG-22CE) once weekly for 3 weeks of every 4 weeks (i.e., on Days 1, 8, and 15). A cycle is 28 days.
15975466|NCT03070977|Other|Interprofessional clinical training unit|"In 2015, Psychiatry in Slagelse established an interprofessional clinical training unit. The aim was to create a new environment for learning, where students could learn from each other and develop competence in interprofessional collaboration. In the training unit there are more students than in the other standard psychiatric wards and several professions are included.
~A facilitator team is responsible for the interprofessional training. In autumn 2016 seven professionals participate in course of facilitating interprofessional collaboration and training. The intervention involved the total staff participation in an initial workshop.
~The training unit is based on two educational interventions: Student participation in clinical care teams and interprofessional group tuition sessions."
15975467|NCT03070964|Drug|plitidepsin|
15975468|NCT03070951|Drug|OBE2109|OBE2109 100mg tablets for oral administration once daily
15975469|NCT03070951|Drug|Placebo to match OBE2109|Placebo to match OBE2109 100mg tablets for oral administration once daily
15975470|NCT03070951|Drug|Placebo to match Add-back|Placebo to match Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
15975471|NCT03070951|Drug|Add-back|Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
15975472|NCT03070938|Device|PuraPly™ Antimicrobial Wound Matrix|PuraPly AM consists of a collagen sheet coated with polyhexamethylenbiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly AM is supplied dry in sheet form. The device is packaged in sterile, sealed single patches.
15975473|NCT03070925|Device|PuraPly™ Antimicrobial Wound Matrix|PuraPly AM consists of a collagen sheet coated with polyhexamethylene biguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly AM is supplied dry in sheet form. The device is packaged in sterile, sealed single patches.
15975474|NCT03070899|Drug|OBE2109|OBE2109 100mg tablets for oral administration once daily
15975475|NCT03070899|Drug|Placebo to match OBE2109|Placebo to match OBE2109 100mg tablets for oral administration once daily
15975476|NCT03070899|Drug|Placebo to match Add-back|Placebo to match Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
15975477|NCT03070899|Drug|Add-back|Add-back (E2 1 mg / NETA 0.5 mg) for oral administration once daily
15975478|NCT03070886|Drug|Bicalutamide|Given orally
15975479|NCT03070886|Drug|Docetaxel|Given IV
15975480|NCT03070886|Radiation|External Beam Radiation Therapy|Undergo external beam radiation therapy
15975481|NCT03070886|Drug|Flutamide|
15975482|NCT03070886|Drug|Goserelin Acetate|
15975483|NCT03070886|Other|Laboratory Biomarker Analysis|Correlative studies
15975484|NCT03070886|Drug|Leuprolide Acetate|
15975485|NCT03070886|Drug|Nilutamide|
15975486|NCT03070873|Device|Perigee and Apogee Mesh|The investigators divided the patients randomly into three groups :the group A received Perigee and Apogee polypropylene mesh(PA)；the group B received Gynecare prolift polypropylene mesh；the group C was without any mesh.
15975487|NCT03070873|Device|Gynecare Prolift Mesh|The investigators divided the patients randomly into three groups :the group A received Perigee and Apogee polypropylene mesh(PA)；the group B received Gynecare prolift polypropylene mesh；the group C was without any mesh.
15975488|NCT03070873|Procedure|Traditional Surgery|The investigators divided the patients randomly into three groups :the group A received Perigee and Apogee polypropylene mesh(PA)；the group B received Gynecare prolift polypropylene mesh；the group C was without any mesh.
15975491|NCT03070847|Drug|Tranexamic Acid|Dose: 10mg/kg
15975492|NCT03070847|Drug|Sodium Chloride|Tranexamic Acid would be diluted in 0,9% Sodium Chloride (0,9% NaCl) to cumulative volume of 20 ml.
15975493|NCT03070834|Device|Cook 'Celect' retrievable inferior vena cava filter|Cook 'Celect' device will be deployed If randomized to rIVCF insertion
15975494|NCT03070821|Other|rtfMRI neurofeedback training|Information about the state of brain activation was given to subjects. That information was visualised as a thermometer bar. Subjects tried to modulate that activation while performing a mental imagery task.
15975495|NCT03070821|Device|3T MRI|A 3T Siemens MRI scanner was used to implement rtfMRI neurofeedback training.
15975496|NCT03070795|Procedure|early feeding|start oral sips four hours after cesarean section
15975497|NCT03070795|Procedure|delayed feeding|start oral feeding on post operation day 1 (>12hours) after surgery
15975498|NCT03070782|Drug|ISIS 681257|ISIS 681257 solution for SC injection.
15975499|NCT03070782|Drug|Placebo|Sterile normal saline (0.9% NaCl)
15975500|NCT03070769|Procedure|Venous blood collection for biomarkers measurements|Venous blood was collected in all subjects for measurements of hs-C-reactive protein (hs-CRP), fibrinogen, erythrocyte sedimentation rate (ESR) and Uric Acid (UA) between 8:00 and 9:00 AM, following an overnight fast, shortly after the conclusion of the overnight polysomnography (PSG).
15975501|NCT03070756|Device|Minimal-Intervention - Specification of device settings|- device settings for auto-CPAP treatment night: therapy mode=APAP, Pmin=5hPa,Pmax=20 hPa, Soft-Start duration <=15 min, softPAP Level is selected based on patient comfort
15975502|NCT03070743|Procedure|Posterior Approach Compression Distraction Reduction Surgery|Posterior Approach Compression Distraction Reduction Surgery is performed.All of patients received this procedure routinely in the department of neurosurgery at Xuanwu Hospital.
15975503|NCT03070730|Drug|Droxidopa|Droxidopa: 100 mg or 300 mg t.i.d
15975504|NCT03070730|Drug|Atenolol|Atenolol: 50 mg Q.D.
15975505|NCT03070730|Drug|Placebos|Placebo: t.i.d
15975506|NCT03070717|Procedure|Observation & Diagnosis|SD-OCT, fundus autofluorescence, fundus photography, optional microperimetry, ophthalmic exams (BCVA, optical biometry), blood sampling.
15975507|NCT03070704|Drug|insulin degludec/liraglutide|Patients will be treated with commercially available Xultophy™ (insulin degludec / liraglutide) according to routine clinical practice at the discretion of the treating physician
15975508|NCT03070691|Drug|LDE225B|Cream, 2x daily
15975509|NCT03070691|Drug|Vehicle|cream, 2x daily
15975510|NCT03070678|Drug|Sotagliflozin (SAR439954)|"Pharmaceutical form: tablet
~Route of administration: oral"
15975511|NCT03070678|Drug|Mefenamic acid|"Pharmaceutical form: capsule
~Route of administration: oral"
15975512|NCT03070665|Drug|Norepinephrine|Increasing blood pressure up to 150mmHg for 5min using norepinephrine pump as initial dose 0.05μg/Kg.min during ESD operation, meanwhile check out the potential hemorrhage spot which is not obvious and then use the hot biopsy forceps to coagulate the bleeding spot, after that withdraw the norepinephrine and record the potential bleeding spot's location. The other procedures are the same as control groups'.
15975513|NCT03070652|Behavioral|NBO, Newborn behavioral observation|
15975514|NCT03070652|Behavioral|Practice as usual|
15975515|NCT03070639|Behavioral|Safe Sleep Intervention|A health educator will visit participant during their 2-week well visit in the clinic, to deliver a tailored intervention based on the baby's sleep practices. Participant will also receive a free pack'n play, sleep sack, and educational resources on safe sleep.
15975516|NCT03070639|Behavioral|Scald Prevention Intervention|A health educator will visit participant during their 2-week well visit in the clinic, to deliver a tailored intervention based on practices regarding scald risks in the home. Participant will also receive a bath thermometer, candy/frying thermometer, and educational resources on scald prevention.
15975517|NCT03070626|Dietary Supplement|PreOp®|No preoperative drink.
15975518|NCT03070613|Drug|Fluorescent Lectin Application|Fluorescein conjugated wisteria floribunda (a lectin).
15975519|NCT03070600|Other|Universal PrEP Counseling|Counseling at universal sites, will use a standardized counseling script to state that PrEP is available for women at risk for HIV, explain that HIV prevalence in the region is high, and will note that women with HIV positive partners or who don't know their partner's status may be at risk. Counseling will specify that women may have their own reasons to feel at risk or to want PrEP. Following standardized counseling, women will select PrEP at the same visit or will be allowed to deliberate on the decision and come back at the next visit with a decision. Women will be informed that it is advisable to use PrEP if they know their partner is HIV positive or if they do not know their partner's status and will be encouraged to bring untested partners to clinic if status is unknown.
15975520|NCT03070600|Other|Targeted PrEP Counseling|"Following enrollment, the targeted PrEP clinics will provide two inter-related innovations over two ANC visits. In the targeted PrEP clinics, any of the following three criteria can trigger enhanced PrEP counseling. A participant that meets any one of these criteria will receive PrEP counseling during the study visit where the criteria is met:
~Risk Score >6 (Risk score includes male partner status known/unknown, syphilis infection, and lifetime number of male partners) or any National AIDS and STI Control Programme (NASCOP) risk factors
~participant declines partner self-tests regardless of partner HIV status, and/or
~their partner declines self-testing or tests positive."
15975521|NCT03070587|Behavioral|Positive Affect Training for SAD|The PAT-S protocol will teach the participants the basics of mindfulness and how to be aware of their physical sensation, thoughts, and emotion at present moment by a nonjudgmental way in breathing, standing, or eating. After two mindfulness sessions, lovingkindness meditation (LKM) will be introduced. The participants will be taught to identify and focus the positive feelings such as gratitude, love, kindness, peacefulness, or friendliness when they wish their benefactor and beloved ones who they feel grateful or respectful, and transfer these feelings first to themselves, then to a neutral individual, to people whom they dislike, and finally to all living beings.
15975522|NCT03070574|Drug|mesalamine 2400 MG (5-ASA)|For this study IMP will be supplied as film-coated tablets packed in containers. Each patient will receive two different containers, each 1200mg of IMP (= 2400 mg), every 3 months (± 1 week), 100 tablets per container. The containers will be marked in different colours, to prevent the patients from taking two tablets from one container accidentally.
15975558|NCT03070366|Drug|Chemotherapy|"cisplatin
~5FU
~carboplatin
~cetuximab"
15975559|NCT03070366|Radiation|Stereotactic radiotherapy|Stereotactic radiotherapy
15975523|NCT03070574|Drug|mesalamine 1200 MG|For this study IMP will be supplied as film-coated tablets packed in containers. Each patient will receive two different containers of IMP (1200 mg/placebo) every 3 months (± 1 week), 100 tablets per container. The containers will be marked in different colours, to prevent the patients from taking two tablets from one container accidentally.
15975524|NCT03070574|Other|Placebo|For this study IMP will be supplied as film-coated tablets packed in containers. Each patient will receive two different containers of IMP (placebo/placebo) every 3 months (± 1 week), 100 tablets per container. The containers will be marked in different colours, to prevent the patients from taking two tablets from one container accidentally.
15975525|NCT03070561|Biological|sublingual film with peanut extract|
15975526|NCT03070548|Drug|Talazoparib|1 mg of talazoparib containing100 μCi of 14C-radiolabeled talazoparib
15975527|NCT03070535|Other|HIGH and LOW meal ingestion|The study will examine CSF biomarker responses to HIGH and LOW meals in 80 men and women with and without the E4 allele in a cross-over design. After an overnight fast, participants will ingest either a HIGH or LOW meal on separate days 3-5 weeks apart in random order. Three hours after meal ingestion, participants will undergo a cognitive battery, followed by spinal fluid collection. Blood samples will also be taken at 7 time points before and after meal ingestion.
15975528|NCT03070522|Drug|Prednisone|oral prednisone for 7 days during pulmonary exacerbation
15975529|NCT03070522|Drug|Placebos|Placebo
15975530|NCT03070509|Drug|Lisdexamfetamine|lisdexamfetamine 50 mg single dose
15975531|NCT03070496|Biological|Blood sampling|Blood sampling will be performed at 6 months after myocardial infarction to analyse diagnostic and prognostic biomarkers
15975532|NCT03070496|Procedure|ECG|ECG will be performed at 6 months after myocardial infarction
15975533|NCT03070496|Device|MRI|MRI will be performed at 1month after myocardial infarction to analyse ventricular remodeling and reperfusion.
15975534|NCT03070496|Other|Quality of life questionnaire|Patients will pass a quality of life questionnaire at 12 months after myocardial infarction
15975535|NCT03070483|Drug|Cholecalciferol|5000 IU cholecalciferol with 1000 mg calcium citrate daily
15975536|NCT03070470|Drug|Ranolazine|Ranolazine 1500 mg orally two times per day for 2.5 days
15975537|NCT03070470|Drug|Verapamil|Verapamil 120 mg immediate release (IR) morning and afternoon doses on Days 1 and 2, 240 mg extended release (ER) evening dose on Days 1 and 2, and 120 mg IR morning dose on Day 3 (all oral doses)
15975538|NCT03070470|Drug|Lopinavir / Ritonavir|Lopinavir / Ritonavir 800 mg / 200 mg orally two times per day for 2.5 days
15975539|NCT03070470|Drug|Chloroquine|Chloroquine 1000 mg on Day 1, 500 mg on Day 2, 1000 mg on Day 3 (all oral doses)
15975540|NCT03070470|Drug|Placebo|Placebo (administered orally)
15975541|NCT03070470|Drug|Dofetilide and Diltiazem|"In one period subjects receive Dofetilide 0.125 mg on Day 1, 0.375 mg on Day 3.
~In a second period (randomized cross-over) subject receive Diltiazem 120 mg IR morning dose on Day 8, 240 mg ER evening dose on Days 8 and 9, and 120 mg IR on Day 10 with coadministration of 0.25 mg dofetilide on Day 10."
15975542|NCT03070457|Other|Early discharge|Patients randomised to early discharge or not
15975543|NCT03070457|Other|Conventional protocol|Discharge as usually done 48-72 hours after surgery
15975544|NCT03070444|Device|CTC retainer|The CTC retainer consists of 0.8 hard Remanium® wire (Dentaurum, Germany) and is bonded with Tetric Flow (Ivoclar Vivadent, Liechtenstein) to the lower canines directly after debonding.
15975545|NCT03070444|Device|Essix retainer maxilla|The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.
15975546|NCT03070444|Device|Essix retainer mandible|The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.
15975547|NCT03070444|Procedure|Alginate impression|Alginate impressions are taken to made the cuspid-to-cuspid and Essix retainers, respectively. Dental casts are obtained at the debond appointment and at the follow-up visits after 6, 18 and 60 months.
15975548|NCT03070444|Other|Questionnaire|A questionnaire is completed at the follow-up visits.
15975549|NCT03070431|Radiation|High-precision RT 5x5 Gy in 1 week|Patients included in this study will receive a high-precision radiotherapy with 5x5 Gy in 1 week
15975550|NCT03070418|Procedure|Mini Incision Dynamic Hip Screw Technique|This technique is the same of AO Dynamic Hip Screw (DHS) technique using 4 holes plate or smaller, in this case it is enough to make just a 3 cm skin incision over the guide wire that is inserted parallel to the anteversion wire by using the 135° guide fixed on the T-handle; (step 2-2), and continuing AO technique steps, until step 3-4, for the plate assembling we remove the guide wire, and insert the plate sliding it through the skin cut over the femur shaft under the muscles using the plate for dissection the soft tissue above the bone surface non using any tool as periosteal elevator but the plate itself by holding it from its DHS screw canal and in 180 degree rotation position in axial aspect (transvers aspect) using the plate end for soft tissue gentle dissection over the bone, then turning the plate 180 degree over the bone shaft to the right position and sliding the DHS screw plat canal over the DHS screw using the measuring bar. Two skin stitches are enough.
15975551|NCT03070405|Drug|Tenofovir disoproxil fumarate 300mg|Single oral dose on the first day of each period
15975552|NCT03070405|Drug|Para-aminosalicylic acid Ca granule 5.28 g|Twice daily oral administration from the first day of each period to the seventh dose
15975553|NCT03070392|Biological|IMCgp100|IMCgp100 is to be administered at 20 mcg cycle 1 day1, then 30 mcg cycle 1 day 8, then 68 mcg cycle 1 day 15 and weekly thereafter by IV infusion over 15 minutes until confirmed disease progression or unacceptable toxicity
15975554|NCT03070392|Drug|Dacarbazine|Dacarbazine is to be administered at 1,000 mg/m2 of body surface area IV infusion every 3 weeks until disease progression or unacceptable toxicity
15975555|NCT03070392|Biological|Ipilimumab|Ipilimumab is to be administered at 3 mg/kg IV infusion over 90 minutes every 3 weeks for a total of 4 treatments
15975556|NCT03070392|Biological|Pembrolizumab|Pembrolizumab is to be administered at 2 mg/kg IV infusion up to a maximum of 200 mg administered Intravenously over 30 minutes every 3 weeks or 200 mg fixed dose administered intravenously every 3 weeks where approved locally until confirmed disease progression or unacceptable toxicity
15975557|NCT03070379|Procedure|Topical lidocaine pharyngeal anesthesia|Topical pharyngeal anesthesia by lidocaine was administrated 4-5 min before propofol sedation in patients who underwent esophagogastroduodenoscopy.
15975560|NCT03070353|Drug|Dextran 40|Dextran-40 infusion with the dose of 1 g/kg/day (10 ml/kg/day) for 2 days.
15975561|NCT03070340|Diagnostic Test|Breast Magnetic Resonance Imaging (MRI)|All women who are scheduled for a post-NAT breast MRI and mammogram will be asked to enroll in the study. The addition of contrast to the FFDM (CEDM) would be the only intervention.
15975562|NCT03070340|Diagnostic Test|Contrast Enhanced Mammography (CEDM)|All women who are scheduled for a post-NAT breast MRI and mammogram will be asked to enroll in the study. The addition of contrast to the FFDM (CEDM) would be the only intervention.
15975563|NCT03070327|Biological|EGFRt/BCMA-41BBz CAR T cell|Modified T cell infusions will be administered 2-7 days following the completion of conditioning chemotherapy.There are 3 planned dose levels for this study: 1x10^6, 3x10^6, and 1x10^7 EGFRt/BCMA-41BBz CAR T cells/kg, and a dose -1 level at 3x10^5 EGFRt/BCMA-41BBz CAR T cells/kg, if needed; each dose cohort will consist of 3-6 patients.
15975564|NCT03070327|Drug|Cyclophosphamide|Cyclophosphamide 3000 mg/m2 IV once on day -7 to -2 or low intensity cy/flu (cyclophosphamide 300 mg/m2/day x 3 + fludarabine 30 mg/m2/day x 3) with the last day occurring on day -7 to -2 are the default options for is the default conditioning chemotherapy.
15975565|NCT03070327|Drug|Lenalidomide.|A cohort of patients will be treated with CAR T cell therapy and concomitant Lenalidomide. 10mg PO 21/28 days will be started no less then 1 week prior to clinical apheresis.
15975566|NCT03070314|Drug|Echinaforce junior|Echinacea Purpurea Extract Pill, sweetened and with orange flavour
15975567|NCT03070301|Drug|LEE011|LEE011 200 mg daily
15975568|NCT03070301|Drug|everolimus|everolimus 5 mg daily or 2.5mg daily
15975569|NCT03070288|Other|Red-green-blue measurements of nasal mucosa image|Adobe Photoshop Elements 7.0 program automatically measures the numerical values of the RGB color components in the selected area
15975570|NCT03070275|Biological|Biocomplex: aBM-MSCs/fibrin glue/collagen fleece|Xeno-free, clinical-grade, autologous alveolar bone marrow mesenchymal stem cells enriched with autologous fibrin glue and loaded into a commercially available collagen fleece.
15975571|NCT03070275|Procedure|Two-stage surgical implant placement|Implants are surgically placed on the alveolar crest following a two-stage protocol and the manufacture's guidelines with no adjunctives.
15975572|NCT03070262|Drug|CA|caffeic acid, 300mg, tid, po
15975573|NCT03070262|Drug|placebo group|placebo tablet, 3 tablets, tid, po
15975574|NCT03070249|Behavioral|Professional Quality of Life (ProQoL) scale|COMPASSION SATISFACTION AND COMPASSION FATIGUE (PROQOL) measures how compassion for those who are cared for can affect providers in positive and negative ways. Questions about experiences, both positive and negative, as a provider reflecting the frequency experiences within the last 30 days. 1=Never 2=Rarely 3=Sometimes 4=Often 5=Very Often
15975575|NCT03070236|Other|Survey|Select questions will be ask in the survey
15975576|NCT03070223|Drug|Pitavastatin|One tablet (4 mg) taken once daily, orally with or without food
15975577|NCT03070223|Drug|Placebos|One tablet taken once daily, orally with or without food
15975578|NCT03070210|Procedure|EUS-celiac ganglia block (EUS-CGB)|The intervention technique of EUS-CGB is the realization of EUS-guided celiac block with injection of bupivacaine directly into the ganglia for patients with chronic pancreatitis.
15975579|NCT03070210|Procedure|EUS-celiac plexus block (EUS-CPB)|In the arm of EUS-CPB, the procedure is going to be performed with the standard EUS-guided celiac plexus block with injection of bupivacaine into the retroperitoneal space.
15975580|NCT03070197|Other|Exposure of interest: Brain MRI|Brain MRI will be conducted in all participants
15975581|NCT03070197|Other|Exposure of interest: neurodevelopmental assessments|neurodevelopmental testing will be conducted in all participants.
15975582|NCT03070184|Other|Exercise capacity VO2 max determination|Each participant's maximal oxygen capacity will be determined using a modified Bruce treadmill protocol.
15975583|NCT03070184|Dietary Supplement|Standardized meals|Participants will consume the standardized study diet for 3 days provided by the clinical research unit's metabolic kitchen (at UAB).
15975584|NCT03070184|Other|Exercise challenge|Each participant will walk at 70 % of his/her VO2max for 20 minutes on treadmill.
15975585|NCT03070184|Drug|Metoprolol Succinate ER|Each participant will receive metoprolol succinate starting at 50mg/day, titrated bi-weekly up to 200 mg/day for total duration of 6 weeks.
15975586|NCT03070171|Drug|dabigatran etexilate|single dose
15975587|NCT03070158|Behavioral|Attachment Promotion|"Attachment Promotion consists of:
~Education session about newborn and mother care.
~Training in multisensory stimulation using the ATVV Intervention (auditory, tactile, visual and vestibular)
~Two domiciliary visits to follow up and to give education about newborn care and ATVV Intervention.
~Daily Phone follows up."
15975588|NCT03070145|Other|Exercise Intervention|12-week moderate-intensity aerobic and strength training exercise intervention
15975589|NCT03070132|Drug|BIIB074|Administered as specified in the treatment arm
15975590|NCT03070132|Drug|Placebo|Matched placebo
15975591|NCT03070119|Drug|BIIB067|Participants will receive a loading dose regimen followed by maintenance dosing.
15975592|NCT03070106|Dietary Supplement|Functional Medicine|Subjects randomized to the Functional Medicine plus the usual care arm will receive nutrition therapy and dietary supplements. Functional Medicine labs will be used in part to determine which supplements will be prescribed.
15975593|NCT03070093|Drug|gilteritinib|oral
15975594|NCT03070080|Procedure|restrictive fluid strategy|restrictive lactated ringers as intraoperative fluid therapy in a dose of 6ml/kg/hour
15975595|NCT03070080|Procedure|conservative fluid strategy|conservative lactated ringers as intraoperative fluid therapy in a dose of 12ml/kg/hour
15975596|NCT03070067|Other|Non-Interventional Study|This is a non-interventional study. However, several blood samples will be taken which would not be taken as part of standard of care.
15975597|NCT03070054|Drug|20ml 0.25% bupivacaine-epinephrine|Extra-capsular local infiltration analgesic (LIA) administration of 20ml 0.25% bupivacaine-epinephrine
15975598|NCT03070041|Other|Baby-friendly Hospital Initiative|The intervention is Baby-friendly Hospital Initiative as described by WHO and UNICEF. The ten steps to successful breastfeeding will be implemented in the hospital.
15975599|NCT03070028|Procedure|crystallised phenol|crystallised phenol will be applied to sinus cavity
15975600|NCT03070028|Procedure|Platelet rich plasma|platelet rich plasma will be applied to sinus cavity
15975601|NCT03070015|Behavioral|Nutrisystem|The Nutrisystem Diet was 1000 kcal/day for week 1,and 1200 calories/day for women and 1500 calories/day for men after week 1.Subjects with BMI > 40 added 200 extra calories/day through grocery food add-ins.Subjects received 7 breakfast,7 lunches,7 dinners, and 14 shakes for week 1.Subjects added in vegetables & no-calorie beverages in week 1.After week 1,Nutrisystem provided 7 breakfasts,6 lunches,6 dinners, and 7 (women) or 14 (men) snacks/week.Subjects prepared 1 lunch & 1 dinner on their own weekly. Guidelines were given to allow subjects to select foods that fit within plan guidelines (~50% kcal from carbohydrate,~25% from protein,~25% from fat). Nutrisystem foods were about 60% of kcal target; grocery additions made the balance.Subjects received guidance as typical on Nutrisystem throughout the study period.Subjects were encouraged to call Nutrisystem counselors. Subjects randomized to this participated in Part A (4 weeks) and Part B (additional 8 weeks) of the study.
15975602|NCT03070015|Behavioral|Self-Directed DASH|The self-directed Dietary Approaches to Stop Hypertension group received instruction/education with handouts & sample meal plans, which met guidelines for DASH. All subjects followed a 1000 kcal/day DASH diet for week 1. After week 1, women ate 1200 kcal/day & men ate 1500 kcal/day. Subjects with BMI >40 added an extra 200 kcal/day. Subjects randomized to this group received one additional educational session beyond the Randomization visit on how to follow their prescribed meal plan. Subjects in this group only participated in Part A (4-weeks) of the study.
15975603|NCT03070002|Biological|Denosumab|Given SC
15975604|NCT03070002|Other|Laboratory Biomarker Analysis|Correlative studies
15975605|NCT03069989|Drug|GSK3008348|Solution for nebulisation. Available as clear colorless to pale yellow colored solution in a 5mL vial with 20 millimeter (mm) stopper and aluminium seal yellow colored solution in a 5mL vial with 20 millimeter (mm) stopper and aluminium seal.
15975606|NCT03069989|Drug|Placebo|Solution for nebulisation. Available as clear colorless to pale yellow colored solution in a 5mL vial with 20mm stopper and aluminium seal.
15975607|NCT03069989|Drug|[18F]-FBA-A20FMDV2|Radio-labeled peptide ligand for PET scan. Available as intravenous (IV) infusion, 20 mL.
15975608|NCT03069976|Drug|Metronidazole|Flagyl x 14 days.
15975609|NCT03069963|Drug|Z0063|"Pharmaceutical form: chewable tablets
~Route of administration: oral"
15975610|NCT03069963|Drug|Gaviscon|"Pharmaceutical form: chewable tablets
~Route of administration: oral"
15975611|NCT03069950|Drug|Floxuridine (FUDR)|5-Fluouracil (5FU) (1000 mg/m2/day continuous infusion over two days)
15975612|NCT03069950|Drug|Irinotecan (CPT-11)|Irinotecan (CPT) (150 mg/m2 IV over 30 min to an hour) on Day 1 and Day 15.
15975613|NCT03069950|Drug|FLUOROURACIL|5-Fluouracil (5FU) (1200 mg/m2/day continuous infusion over two days)
15975614|NCT03069950|Drug|PANITUMUMAB|Panitumumab (6 mg/kg IV over 60 min)
15975615|NCT03069950|Drug|DEXAMETHASONE|flat dose of 25 mg on Day 1
15975616|NCT03069950|Drug|Leucovorin|Leucovorin (LV) (400 mg/m2 IV over 30 min to an hour)
15975617|NCT03069937|Drug|Docetaxel|The docetaxel dose is a 75mg/m2 intravenous (given through the vein) injection.
15975618|NCT03069937|Drug|Degarelix|Degarelix will be given as a subcutaneous (given under the skin) injection in the abdomen. The first dose will be a 240mg dose; all other doses will be 80 mg.
15975619|NCT03069924|Behavioral|Gain-framed messaging|counseling plus gain-framed messaging
15975620|NCT03069924|Drug|Nicotine replacement therapy|counseling plus NRT
15975621|NCT03069924|Combination Product|Gain-framed messaging plus NRT|counseling plus gain-framed messaging and NRT
15975622|NCT03069924|Behavioral|Counseling alone|Counseling only
15975623|NCT03069911|Biological|OnabotulinumtoxinA|OnabotulinumtoxinA (29 units for women; 40 units for men) diluted with 0.9% sodium chloride (saline) solution to 40 units per milliliter (mL) (0.725 mL for women, 1 mL for men)
15975624|NCT03069911|Biological|Control|0.9% sodium chloride solution (saline) solution injections (0.725mL for women, 1mL for men)
15975625|NCT03069898|Behavioral|TRUE Dads|The TRUE Dads intervention consists of a set of 12 3-hour workshops that focus on enhancing fathers' role as co-parent, parent, and provider
15975626|NCT03069885|Device|Prevena|Incisional negative pressure wound therapy (iNPWT), is a new approach for surgical site closure using negative pressure wound therapy (NPWT). Recently, PrevenaTM have been approved as an iNPWT-system applied at the end of surgery, while still in a sterile environment. PrevenaTM consist of a sponge foam with a bactericidal silver lining dressed with an adherent film, connected to a vacuum device, producing a vacuum of 125 mm Hg. The PrevenaTM foam and dressing is placed over the suture line, and is recommended to be kept in place for a continuous period lasting between 2 and 7 days.
15975627|NCT03069885|Other|Standard Postoperative dressing|The standard postoperative dressing, using steri strips placed over the suture line.
15975628|NCT03069872|Diagnostic Test|Transvaginal ultrasound|Access to fast transvaginal ultrasound through general practice Develop and conduct training for general practicioners in the latest knowledge of ovarian cancer symptomatology
15975629|NCT03069859|Drug|TXA (1g)|1 gram of TXA (10 mL) diluted into 0.9% saline, 50 ml mini-bag (a total of 60 mL)
15975630|NCT03069859|Drug|Placebo (0.9% saline)|0.9% saline (10 mL), diluted into 0.9% saline, 50 ml mini-bag (a total of 60 mL)
15975631|NCT03069846|Device|Spectra-Scope|"The Spectra-Scope consists of the light collection module and the spectral analysis module.
~The light collection module is attached to the handpiece of short pulse Nd:YAG laser, and the analysis module is placed on the laser.
~Each potential skin cancer site, which has previously been identified as requiring biopsy, should be assessed using five laser shots that last approximately 10 milliseconds per shot and measurement. The laser shots must be made before the scheduled biopsy.
~All potentially cancerous lesions (or lesions that would usually undergo complete biopsy of the lesion or require follow up within three months) should be sampled. The Spectra-Scope will not provide a diagnosis at the time of sampling. Sites should record the spectra reported for each laser shot in the CRF."
15975632|NCT03069833|Diagnostic Test|Computer-aided diagnosis|computer-aided diagnosis to assist colonoscopists
15975633|NCT03069820|Drug|docetaxel and cisplatin|Patients receive TP (docetaxel and cisplatin) chemotherapy
15975634|NCT03069807|Other|Community/Primary Care|The treatment of Latent Tuberculosis Infection (LTBI) in the community by General Practitioners (Family Doctors) and Pharmacists
15975635|NCT03069807|Other|Hospital/TB Clinic|The treatment of Latent Tuberculosis Infection (LTBI) in the Hospital TB Clinic by specialist doctors and nurses
15975795|NCT03068624|Biological|Autologous CD8+ SLC45A2-specific T Lymphocytes|Given via hepatic arterial infusion via central catheter
15975636|NCT03069794|Diagnostic Test|Use of stable force platform|Use of stable force platform to appreciate the posture before and after spinal surgery
15975637|NCT03069781|Drug|17β-estradiol|1mg/day for 3-days and 3mg/day for 7-days of Estrance
15975638|NCT03069781|Drug|Polycose|400 mg/day for 10-days of Polycose (Abbott Laboratories, St. Laurent, QC, Canada)
15975639|NCT03069768|Device|mSMART|A smartphone application that targets medication adherence in substance users, providing information and reminders and tracking medication usage and factors interfering with adherence.
15975640|NCT03069768|Drug|Chantix|For the first 3 days smokers in this group will receive treatment with Chantix at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12-week active treatment duration.
15975641|NCT03069755|Other|No intervention|No intervention
15975642|NCT03069742|Other|RealRisks|RealRisks is a web-based patient decision aid with modules that present information about risk assessment and chemoprevention.
15975643|NCT03069742|Other|BNAV|Breast Cancer Risk Navigation (BNAV) tool is a web-based decision support tool with modules that present pertinent information for primary care providers regarding breast cancer risk assessment and preventative measures for their patients.
15975644|NCT03069729|Other|no intervention|This study evaluates s system intended to detect bio-markers of DPN. No interventions are involved in this non-invasive study.
15975645|NCT03069716|Device|Smartphone Text Messaging|A HIPPA compliant text messaging platform is linked to the Fitbit Application Program Interface. Real time activity data will be transmitted from the subject's smartphone to our mHealth platform via cellular network. Subjects will receive 3 texts/day in sync with their preferred morning, lunch, and evening leisure schedule (defined at enrollment). These texts will use personal, disease-specific, and provider information to deliver 2 types of messages customized to the current step count and sent in equal proportion. Messages are designed to facilitate self-awareness, reinforce step targets, and link physical activity with a reward or memorable cue.
15975646|NCT03069716|Device|Fitbit Charge HR|The Fitbit Charge HR tri-axial accelerometer will be used to continuously gather data on physical activity, heart rate, and sleep. This device provides feedback in units of activity (steps, stairs climbed, activity time, and exercise time) and heart rate (per second when active, per 5 seconds when inactive). It has been validated against research devices in free-living conditions and is relatively inexpensive.
15975647|NCT03069703|Biological|PCV13|one dose of PCV13 at D0 (arm A) or two double doses at D0 and D7 (Arm B) or one quadruple dose at D0 (arm C)
15975648|NCT03069703|Biological|PPV23|one dose of PPV23 at M5
15975649|NCT03069703|Drug|Rituximab|375 mg/m2/week for 4 consecutive weeks, at Days 0 ± 2 days, Day 7 ± 2 days, Day 14 ± 2 days and Day 21 ± 2 days, as induction therapy of vasculitis flare, followed by 500 mg-rituximab infusion every 6 months as maintenance therapy, i.e. at Month 6, Month 12 and Month 18
15975650|NCT03069690|Behavioral|HABITpreg|"Treatment during pregnancy will consist of up to 10 in person sessions taking place at regularly scheduled obstetric appointments, at the investigator's research building, or a nearby location. Participants in the HABITpregnancy group will also receive texts and phone calls between sessions. HABIT will focus on weight, physical activity, eating and psychosocial issues. Women will receive consultation about nutritional balance, dietary guidelines for pregnant women and advice to maintain an optimal rate of weight gain according to prepregnancy BMI. Women will use self-monitoring forms to identify and modify cues for unhealthy behaviors. Beliefs about body weight and eating during pregnancy will be addressed and effects of physical activity on body weight, health, and mood will be included.
~Due to COVID-19 restrictions and safety guidelines, HABIT pregnant treatment sessions have been taking place virtually, using video chat or phone calls starting in March 2020."
15975651|NCT03069690|Behavioral|HABITpost|"Treatment during the postpartum period (HABITpost) will consist of an intervention over the 24 weeks immediately following delivery. Treatment will include 12 biweekly sessions completed over the phone or in person. In person sessions will be done at the participant's home or another convenient location. Additionally, participants will receive calls and texts between sessions. Sessions will focus on weight, physical activity, eating and psychosocial issues.
~Due to COVID-19 restrictions and safety guidelines, HABIT post treatment sessions have been taking place virtually, using video chat or phone calls starting in March 2020."
15975652|NCT03069677|Other|music|patients in this group will receive research-selected music after the golden moment has been completed between the patient, provider, and nursing staff
15975653|NCT03069677|Drug|Midazolam|patients in this group will receive IV midazolam (1mg to 2mg max) after the golden moment has been completed
15975654|NCT03069664|Procedure|ERCP|endoscopic retrograde cholangiopancreatography
15975655|NCT03069664|Device|Covered Self-expandable Metal Stent|Pancreatic duct stent
15975656|NCT03069651|Other|Virtual Care|The use of Videoconferencing software to enable remote access to monitor patients in the 'Virtual Care' cohort.
15975657|NCT03069638|Drug|Dexmedetomidine|Intranasal administration of dexmedetomidine as a procedural sedation (intra-articular joint injection)
15975658|NCT03069638|Drug|Sedatives/Hypnotics,Other|Inhaled dinitrous oxide as procedural sedation (intra-articular joint injection)
15975659|NCT03069625|Behavioral|Sit-to-stand test|CF young patients will perform 2 STS tests. Number of repetitions, cardio-respiratory response and physiological adaptations during the second test will be monitored.
15975660|NCT03069625|Behavioral|6-Minute Walk Test|CF young patients will perform 2 6MWT tests. Number of repetitions, cardio-respiratory response and physiological adaptations during the second test will be monitored.
15975661|NCT03069612|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|rTMS administered bilaterally to the DLPFC at 20 Hz, 90% RMT, 25 trains
15975662|NCT03069599|Procedure|irreversible electroporation (IRE)|Irreversible electroporation is an emerging, mainly non-thermal ablative modality. It circumvents some downsides of thermal ablation and has the potential for broad application among patients with pancreatic cancer.
15975663|NCT03069586|Procedure|Pulmonary recruitment|At the end of surgery a manual pulmonary recruitment (5 sec, max 40 cmH2O) is given to the patiënt
15975664|NCT03069586|Procedure|No pulmonary recruitment|At the end of surgery no intervention was completed
15975665|NCT03069560|Device|SMS|SMS contact from the caregiver with patient after discharge in intervention group
15975796|NCT03068624|Drug|Cyclophosphamide|Given IV
15975797|NCT03068624|Biological|Ipilimumab|Given IV
15975666|NCT03069547|Other|Quadriceps Exercise program|"The exercise program is initiated at an individual clinical visit. An experienced physiotherapist introduces the participant to the exercise program and provides instructions to the individual exercises. An experienced physiotherapist provides the monthly supervision visits.
~The program details can be requested rom the responsible party. In brief the QE-program consists of:
~- A short warm-up and 3 specific exercises for the quadriceps muscle
~Progression of the exercise intensity is done by adding (additional) external loads, such as elastic rubber bands, free weights, etc."
15975667|NCT03069547|Other|Hip Exercise program|"The exercise program is initiated at an individual clinical visit. An experienced physiotherapist introduces the participant to the exercise program and provides instructions to the individual exercises. An experienced physiotherapist provides the monthly supervision visits.
~The program details be requested rom the responsible party. In brief the HE-program consists of:
~- A short warm-up and 3 specific exercises for the hip abductor and extensor muscles
~Progression of the exercise intensity is done by adding (additional) external loads, such as elastic rubber bands, body weight etc."
15975668|NCT03069534|Drug|RhIL-2|RhIL-2 treatment intervention was consisted of four courses of low-dose rhIL-2 plus standard anti-tuberculosis chemotharapy. rhIL-2 (500,000 U/m)regimen was given subcutaneously (SC) once every other day (q.o.d.) for 30 days and four courses were carried out separately during months 1, 3, 5, and 7.
15975670|NCT03069508|Drug|Clemizole Hydrochloride|Clemizole Hydrochloride will be administered orally for up to 24 weeks
15975671|NCT03069482|Device|Learn to Quit App|A smartphone app designed for individuals with serious mental illness. The main intervention components of the app are skills based on an intervention called Acceptance and Commitment Therapy that will (a) teach smoking cessation skills and (b) help cope with mental health symptoms. The app incorporates gaming features to keep users engaged, and a tracking component to record smoking habits and moods.
15975672|NCT03069482|Drug|Nicotine patch|Participants enrolled in the study will be given an 8-week course of Nicotine patches. The 8-week course of trans-dermal nicotine patches starting at 21mg/24h for 4 weeks, then transitioning to 14mg/24h for 2 weeks, and finally to 7mg/24h for the last 2 weeks. This dosing will follow recommendations contained in the US DHHS Clinical Practice Guidelines.
15975673|NCT03069482|Drug|Nicotine lozenge|Each participant will be given a 1-week course of 4mg Nicotine lozenges to be taken orally as nicotine cravings arise (about 10 lozenges per day). They will be directed to use them for the week following their quit date, using no more than once every 1-2 hours. This dosing will follow recommendations contained in the US DHHS Clinical Practice Guidelines.
15975674|NCT03069482|Behavioral|Technical Coaching|Coaching to assist the user on the use of each assigned smartphone app. This coaching will be delivered by research staff following a coaching procedure. These in-person coaching meetings will be brief (~15 minutes), done on a weekly basis for 4 weeks, and will have a focus on providing technical assistance.
15975675|NCT03069482|Device|NCI QuitGuide App|A smartphone app developed by the National Cancer Institute which uses recommendations contained in the US DHHS Clinical Practice Guidelines and smokefree.gov. NCI QuitGuide has the following intervention components: (a) psycho-education about the impact of smoking in health, (b) tracking of smoking habits, and (c) Tips for quitting (e.g., distraction strategies).
15975676|NCT03069469|Drug|DCC-3014|CSF1R inhibitor
15975677|NCT03069456|Device|BIS|
15975678|NCT03069456|Device|ADMS|
15975679|NCT03069443|Other|IHG home training|Participants of the intervention group will follow the IHG home training protocol for 20 weeks. The IHG training consists of isometric contractions applied with the hands on a Wii.
15975680|NCT03069430|Behavioral|SELFY (Self Management for Youth with SCD)|The intervention will be delivered via a mobile device (tablet) and consists of three components. 1. Education, will consist of continuous access to electronic educational resources on the SCD process, treatment, home management strategies, symptom prevention and management strategies. To address potential literacy barriers, an application that reads PDF files aloud will be downloaded onto devices. 2. symptom monitoring and tracking, will consist of an application for tracking and monitoring pain in SCD that also permits upload of symptom logs and text alerts to a health care provider. 3. caregiver-provider communication, consists of SMS messaging with a nurse who will: respond to alerts, monitor pain symptoms delivered via the mHealth application, and respond to text messages.
15975681|NCT03069417|Behavioral|Integrating Nuanced Support for Perinatal adherence and Depression|A 5-8 session intervention to decrease depressive symptoms and improve antiretroviral adherence among HIV-infected pregnant and postpartum women
15975682|NCT03069391|Behavioral|physical exercise alone (PES) first|following 2-week placebo for all participants, participants in this arm will then start their active intervention with a randomly assigned 2-week physical exercise-only intervention, then 2-week cognitive exercise-only intervention, then 2-week and 3 month intervals of iPACES™ (interactive physical and cognitive exercise)
15975683|NCT03069391|Device|cognitive exercise alone (iCE) first|following 2-week placebo for all participants, participants in this arm will then start their active intervention with a randomly assigned 2-week cognitive exercise-only intervention, then 2-week physical exercise-only intervention, then 2-week and 3 month intervals of iPACES™ (interactive physical and cognitive exercise)
15975684|NCT03069391|Device|interactive Physical and Cognitive Exercise (iPACES™)|following 2-week placebo for all participants, participants in this arm will then start their active intervention with a randomly assigned 2-week cognitive exercise-only intervention, then 2-week physical exercise-only intervention, then 2-week and 3 month intervals of iPACES™ (interactive physical and cognitive exercise)
15975685|NCT03069378|Drug|Talimogene Laherparepvec (T-VEC)|Talimogene laherparepvec treatment will be given at Day 1 Week 1, and every 3 weeks thereafter .
15975686|NCT03069378|Drug|Pembrolizumab|Pembrolizumab will be given at Day 1 week 1 and every 3 weeks thereafter.
15975687|NCT03069365|Drug|Glecaprevir/pibrentasvir|Film-coated tablet
15975688|NCT03069352|Drug|Placebo|tablet
15975689|NCT03069352|Drug|Venetoclax|tablet
15975690|NCT03069352|Drug|Cytarabine|Subcutaneous injection
15975691|NCT03069339|Drug|Carvedilol|Carvedilol will start at starting dose of 3.125 mg BD followed by 6.25 mg BD followed by 12.5 mg BD if BP 90/60 mmHg and HR 55/min
15975692|NCT03069339|Procedure|Endoscopic Variceal Ligation|EVL will be done every 3 weeks till eradication
15975693|NCT03069326|Drug|Ruxolitinib|Ruxolitinib will be given orally in an outpatient setting unless the patient is being seen inpatient for another reason. Ruxolitinib will be given continuously orally daily in 28-day cycles.
15975694|NCT03069326|Drug|Thalidomide|Thalidomide will be given orally in an outpatient setting unless the patient is being seen inpatient for another reason. thalidomide will be given continuously orally daily in 28-day cycles.
15975695|NCT03069313|Dietary Supplement|Vitamin B12|Vitamin B12 2500 micrograms sublingually per day over the course of 90 days (+/- 10 days)
15975696|NCT03069300|Drug|N-acetyl cysteine (NAC)|
15975697|NCT03069287|Behavioral|Benjamin Rose Institute (BRI) Care Consultation™ Program|The BRI Care Consultation™ can be delivered via face-to-face contact, telephone, mail, and/or email by a Care Consultant and caregiver who assists with daily activities, tasks, and health-related issues. BRI CareConsultation™ uses a secure, web-based Care Consultation Information System (CCIS) to guide the delivery of the intervention.
15975698|NCT03069274|Behavioral|Intervention|General nutritional recommendations, change drinking habits
15975699|NCT03069274|Behavioral|General nutritional recommendations|Only general nutritional recommendations were given
15975700|NCT03069261|Device|Indocyanine green angiography|
15975701|NCT03069248|Drug|Rituximab|
15975702|NCT03069248|Drug|Alpha Interferon|
15975703|NCT03069235|Behavioral|Family member / peer support|supplemental individualized counselling
15975704|NCT03069235|Behavioral|Enhanced intervention with counselor support|"hands on EBF demonstrations"
15975705|NCT03069235|Behavioral|standard of care|one on one and in-group counselling
15975706|NCT03069222|Other|Standard Rehabilitative Treatment|The patients will participate in standard but comprehensive SCI specific rehabilitation therapy provided by the SCI program at KIR. The therapy consists of 3 hours per day, 5 days a week. Motor function therapy includes standardized procedures for range of motion, passive and active muscle activities, and therapies to improve mobility. The treatment program for the enrolled patients will be standardized by Dr. Kirshblum, Director of the SCI program at KIR and a Co-Investigator of the study. Patients usually receive 4 weeks of rehabilitation treatment; however, if any of them are discharged earlier from KIR, their out-patient treatment activities will be monitored and the patients will be tested based on the planned schedule.
15975707|NCT03069209|Biological|Stem Cells|Intraovarian transplantation of autologous purified bone marrow-derived stem cells and mesenchymal stem cells.
15975708|NCT03069183|Drug|0.5% Ropivacaine|Ultrasound-guided suprainguinal fascia iliaca compartment block with 40mls 0.5% ropivacaine.
15975709|NCT03069183|Drug|Normal saline|Ultrasound-guided suprainguinal fascia iliaca compartment block with 40mls normal saline.
15975710|NCT03069170|Biological|Stem Cell Transplantation|Intravenous and Intrathecal injections of purified autologus bone marrow-derived stem cells.
15975711|NCT03069157|Procedure|lung recruitment maneuver|lung recruitment manoeuvre will be performed in patients using continuous positive airway pressure( CPAP) (30) cm H2O for (40) seconds after induction of anesthesia then patient will be converted to pressure controlled mode again with PEEP 5 cm H2O
15975712|NCT03069144|Drug|HAT1 topical solution|HAT1 topical solution will be applied twice daily. The research team will provide instructions for the correct application of the treatment. If a lesion disappears, patients will continue applying the cream twice daily to the area. No additional creams, lotions or soaps other than provided test products will be allowed throughout the duration of the study.
15975713|NCT03069144|Drug|Calcipotriol|Calcipotriol ointment (0.005%) will be applied twice daily. The research team will provide instructions for the correct application of the treatment. If a lesion disappears, patients will continue applying the cream twice daily to the area. No additional creams, lotions or soaps other than provided test products will be allowed throughout the duration of the study.
15975714|NCT03069131|Drug|Rifaximin|twice daily administration of 1 tablet containing 550 mg of active rifaximin
15975715|NCT03069131|Other|Placebo|twice daily administration of 1 rifaximin placebo tablet
15975716|NCT03069118|Behavioral|Treatment - Workit Health Online Program|"The Workit Health program is an adaptive recovery in your pocket harm reduction and sobriety solution that provides 24-hour access to adaptive lessons, mentorship, written and audio driven therapeutic exercises and tools, and peer-to-peer coaching. Users access our online site and enter an initial 90-day program that takes a holistic approach to recovery by addressing the physical, mental, emotional, and social aspects of addiction. As they advance, they move through successive levels that include lessons, activities, and assignments. Bonus materials, such as meditations and suggested reading, give users timely opportunities to dive deeper into a problem they are struggling with that day. Workit Health implements evidence-based strategies such as CBT, DBT, and MI."
15975717|NCT03069118|Behavioral|Control - Resource List|Tailored list of resources.
15975718|NCT03069105|Other|Questionnaire|Participants will complete paper and pencil or electronic questionnaires at the cancer center or in the privacy of their own homes.
15975719|NCT03069092|Behavioral|aerobic exercise|AE training will consist of 60 min of treadmill, elliptical, or bike exercise at a moderate to vigorous intensity (50-80% of heart rate reserve). Intensity of the exercise sessions will be built up gradually. Sessions will occur 3 times per week for the duration of the 1 year trial.
15975720|NCT03069092|Behavioral|resistance exercise|RE will consist of 3 sets of 8-15 repetitions at 50-80% of 1 rep-max of each exercise for 12 exercises (chest press, shoulder press, pull-down, back extension, abdominal crunch, torso rotation, biceps curl, triceps extension, leg press, leg extension, leg curl, and calf raise). Weight loads will be increased gradually. With one minute of rest between sets, this plan is estimated to take approximately 60 minutes per session. Sessions will occur 3 times per week for the duration of the 1 year trial
15975721|NCT03069092|Behavioral|Combined resistance and aerobic exercise|Participants will perform exactly the same AE and RE exercises as listed previously; however, the time of AE and RE will each be reduced to 30 min (for 60 min/session total). For the RE aspect, participants will perform 2 sets of 8-15 repetitions of 9 exercises (excluding biceps curl, triceps extension, and calf raise, as these are minor muscle groups). Exercise intensity and resistance will be increased gradually. Combined AE and RE sessions will take place 3 times per week for the duration of the trial.
15975798|NCT03068611|Behavioral|Standard Web-based Smoking Cessation|A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
15975722|NCT03069079|Procedure|Oral hygiene advice, non surgical periodontal treatment|For children affected by periodontal disease, oral hygiene advice, non surgical periodontal treatment will also be performed according to needs. This can be accompanied, when appropriate, by the use of local anaesthesia and adjunctive antimicrobials (systemic or locally applied subgingivally), according to the clinical presentation and the child's medical conditions. Accurate supra- and sub-gingival removal of calculus and dental plaque will be performed both with ultrasonic and/or manual instruments. The necessary sub-gingival debridement will be performed in 1 to 4 visits (either full mouth treatment, half-mouth treatment or quadrant-wise treatment) depending on patient preference and practical considerations, using manual (Gracey curettes, Hu-Friedy) and ultrasonic devices (EMS). .
15975723|NCT03069066|Device|Bioresorbable vascular scaffold. Absorb GT1 (Abbott)|
15975724|NCT03069040|Procedure|nerve sparing radical hysterectomy|Type C1 radical hysterectomy,that is nerve sparing radical hysterectomy, requires separation of two parts of the dorsal parametria: the medialpart , which entails recto -uterineandrecto-vaginal ligaments, and the lateral laminar structure, also called mesoureter, which contains the hypogastric plexus. Furthermore, type C1 requires only a partial dissection of the ureter from the ventral parametria, which is usually asymmetric towards more extensive resection of the medial leaf of the cranial (above the ureter) part of the ventral parametria .
15975725|NCT03069040|Procedure|radical hysterectomy|In the C2 type, the ureter is completely dissected from the ventral parametria up to the urinary bladder wall. Defining the resection limits on the longitudinal (deep parametrial or vertical) plane is crucial for distinguishing between types C1 and C2.
15975726|NCT03069027|Procedure|External nasal nerve block|Three single (midline injection) and 4 paired (bilateral injection) sites to block the external nasal sensation.
15975727|NCT03069027|Drug|saline adrenaline|
15975728|NCT03069027|Drug|Xylocaine, adrenaline|
15975729|NCT03069014|Drug|400mg LM11A-31-BHS|1 Oral Capsules (200mg of LM11A-31-BHS and 200mg of placebo) twice daily (morning & evening) for 26 weeks
15975730|NCT03069014|Drug|800mg LM11A-31-BHS|2 Oral Capsules (200mg of LM11A-31-BHS) twice daily (morning & evening) for 26 weeks
15975731|NCT03069014|Drug|Placebos|2 Oral Capsules (200mg of Placebo) twice daily (morning & evening) for 26 weeks
15975732|NCT03069001|Drug|Sofosbuvir-Simeprevir|-Sofosbuvir-Simeprevir group included 50 patients who received sofosbuvir 400 mg orally once-daily plus simeprevir 150 mg orally once-daily for 12 weeks.
15975733|NCT03069001|Drug|Sofosbuvir-Ribavirin|-Sofosbuvir-Ribavirin group included 40 patients who received sofosbuvir 400 mg orally once-daily plus ribavirin orally twice-daily for 24 weeks.
15975734|NCT03068988|Biological|mesenchymal stem cells|mesenchymal stem cells concentrate into the supraspinatus footprint during the surgery
15975735|NCT03068988|Procedure|without mesenchymal stem cells|rotator cuff surgery without mesenchymal stem cells
15975736|NCT03068975|Drug|Alvimopan|Patients who sustained abdominal trauma with resection of bowel and anastomosis will receive Alvimopan ( post operative dose only) and will monitor for post operative ileus.
15975737|NCT03068975|Drug|Placebo|Patients who sustained abdominal trauma with resection of bowel and anastomosis will receive the Placebo Pill (post operative dose only) and will monitor for post operative ileus.
15975738|NCT03068962|Other|beetroot Juice|Beetroot Juice
15975739|NCT03068962|Other|Buxton water|natural mineral water
15975740|NCT03068962|Other|antiseptic mouthwash then beetroot juice|Chlorhexidine glocunate
15975741|NCT03068949|Biological|FluBlok|FluBlok trivalent Influenza Vaccine .5 mL given Intramuscularly
15975742|NCT03068949|Biological|Fluzone|Fluzone Quadrivalent Influenza Vaccine .5 mL given intramuscularly
15975743|NCT03068949|Biological|FluCelVax|FluCelVax Quadrivalent Influenza Vaccine .5 mL given intramuscularly
15975744|NCT03068949|Biological|Fluzone HD|Fluzone HD Trivalent High Dose Influenza Vaccine .5 mL given intramuscularly
15975745|NCT03068936|Radiation|Intensity modulated radiotherapy|Intensity modulated radiotherapy once a day, 5 times a week, continuous treatment for about 6 weeks (DT 70Gy)
15975746|NCT03068936|Drug|Cisplatin|Synchronous cisplatin (100mg / m2 / times) chemotherapy, once every 3 weeks, a total of 2 times
15975747|NCT03068910|Drug|Micronized progesterone|Micronized progesterone 0.8 mg/kg at 0700, 1500, 2300 and 0700 h. Progesterone is a natural hormone.
15975748|NCT03068910|Drug|Spironolactone|Spironolactone is an androgen-receptor blocker commonly used (off-label) for hyperandrogenism. The spironolactone dose will be 50 mg taken orally twice daily (for two weeks before admission to the Clinical Research Unit).
15975749|NCT03068910|Drug|Placebo|Placebo contains only inert ingredients and is not expected to exert any direct physiological effects.
15975750|NCT03068897|Drug|Metaxalone|Metaxalone 400-800mg
15975751|NCT03068897|Drug|Tizanidine|Tizanidine 2-4mg
15975752|NCT03068897|Drug|Baclofen|Baclofen 10-20mg
15975753|NCT03068897|Drug|Ibuprofen 600 mg|Ibuprofen
15975754|NCT03068897|Behavioral|Educational intervention|Research personnel will provide each patient with a 15-minute educational intervention. This will be based on NIAMS's Handout on Health: Back Pain information webpage (available at http://www.niams.nih.gov/Health_Info/Back_Pain/default.asp) Research personnel will review each section of the information sheet with the patient and elicit questions.
15975755|NCT03068884|Device|Cathodal Transcranial direct current stimulation|Cathodal transcranial direct current stimulation over the dorsolateral prefrontal cortex
15975756|NCT03068884|Dietary Supplement|L-Tyrosine|Administration of 2 grams tyrosine
15975757|NCT03068884|Device|Transcranial direct current stimulation (sham)|Sham tDCS
15975758|NCT03068884|Dietary Supplement|Cellulose (placebo)|Administration of 2 grams cellulose
15975759|NCT03068871|Other|ACT|Psycho-educational group
15975760|NCT03068871|Other|CET|Psycho-educational group
15975761|NCT03068858|Diagnostic Test|real-time feedback of SYNTAX score category|
15975799|NCT03068611|Behavioral|Alcohol-focused Web-Based Smoking Cessation|A website and text messaging program that is publicly available through BecomeAnEX.com. Participants have access to the website whenever they wish.
15975835|NCT03068260|Drug|Acetaminophen|1 g orally administered postoperatively
15975836|NCT03068260|Drug|Ibuprofen 400Mg Tablet / Celebra 100 Mg tablet|orally administered postoperatively
15975837|NCT03068260|Device|ultrasound-guided nerve block|Transmuscular quadratus lumborum block, ultrasound-guided
15975762|NCT03068845|Device|Drug-eluting balloon angioplasty (DEBA)|"DEBA will be performed after pre-dilatation of the target lesion for subjects allocated to the experimental arm.
~If there is more than 1 stenosis, only the most severe stenosis will be designated the target lesion and treated according to treatment allocation. All other stenoses will be treated with conventional balloon angioplasty.
~High pressure balloon angioplasty may be performed if there is poor angioplasty results (significant residual stenosis of more than 30%).
~All patients will be started on dual antiplatelets (aspirin and clopidogrel) for 1 month after intervention, followed by 5 months of aspirin."
15975763|NCT03068845|Device|Conventional Balloon Angioplasty (CBA)|"CBA will be performed for the target lesion for subjects allocated to the active comparator arm.
~If there is more than 1 stenosis, only the most severe stenosis will be designated the target lesion and treated according to treatment allocation. All other stenoses will be treated with conventional balloon angioplasty.
~High pressure balloon angioplasty may be performed if there is poor angioplasty results (significant residual stenosis of more than 30%).
~All patients will be started on dual antiplatelets (aspirin and clopidogrel) for 1 month after intervention, followed by 5 months of aspirin."
15975764|NCT03068832|Biological|Personalized peptide vaccine|-It may take 3-4 months for sequencing, neoantigen prediction, and peptide manufacturing
15975765|NCT03068832|Drug|Poly ICLC|-Poly-ICLC is supplied by Oncovir in single-dose vials containing 1 mL of 2 mg/mL opalescent white suspension.
15975766|NCT03068832|Procedure|Peripheral blood draw|"After trial enrollment and up to 7 days after the 1st vaccine dose
~2 weeks after last dose
~Time of progression or discontinuation"
15975767|NCT03068819|Drug|CIML NK Cell Infusion|-Day 0
15975768|NCT03068819|Procedure|CD3+ T Cell Product Infusion|-Day -1
15975769|NCT03068806|Diagnostic Test|Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)|The investigators will use these techniques combined with attention tests, memory tests, and clinical interviews to explore connections between these measures and activity in the brain in patients with a diagnosis of schizophrenia and healthy controls.
15975770|NCT03068793|Diagnostic Test|Electroencephalography (EEG) and Magnetic Resonance Imaging (MRI)|We will use these techniques combined with tests of reward anticipation and clinical interviews to explore connections between these measures and activity in the brain in patients with a diagnosis of schizophrenia, major depressive disorder, gambling disorder, or post traumatic stress disorder and healthy controls.
15975771|NCT03068780|Drug|Oleogel-S10|10% birch bark extract in 90% sunflower oil
15975772|NCT03068780|Drug|Placebo|Sunflower oil gel
15975773|NCT03068767|Dietary Supplement|Vitamin D|
15975774|NCT03068754|Drug|Acthar|Repository corticotropin for subcutaneous injection
15975775|NCT03068754|Drug|Placebo|Matching placebo for subcutaneous injection
15975776|NCT03068741|Drug|Comparison 1: Prehospital Ceftriaxone|Paramedics will administer 1g of intramuscular ceftriaxone.
15975777|NCT03068741|Drug|Comparison 1: Placebo|Paramedics will administer an identical volume of reconstituted intramuscular placebo.
15975778|NCT03068741|Drug|Comparison 2: Liberal fluids|Paramedics will administer up to 2 litres of intravenous saline (0.9%) to all patients regardless of systolic blood pressure, and reassessing this infusion after each 250ml are infused.
15975779|NCT03068741|Drug|Comparison 2: Conservative fluids|Paramedics will administer intravenous saline (0.9%) according to the Medical Directive, which allows for infusion of fluids if systolic blood pressure is <90mmHg and continued until systolic blood pressure is >=100mmHg.
15975780|NCT03068728|Device|Arista|
15975781|NCT03068728|Device|Nexfoam|
15975782|NCT03068728|Device|Nasopore|
15975783|NCT03068715|Device|Active TBS-DLPFC|"Participants in the active stimulation group will receive intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of RMT and adjusted to the skull to cortical surface distance (see Nahas 2004).
~Stimulation will be delivered to the L-DLPFC using a MagPro stimulator."
15975784|NCT03068715|Device|Sham TBS-DLPFC|The parameters in the active arms will be as above with the internal randomization of the device internally switching to sham in a blinded fashion.
15975785|NCT03068715|Device|Open label TBS-DLPFC|"All patients will have the option to receive active, open label aTBS treatment after the 1-month mark, following the blinded phase.
~Stimulation will be delivered to the L-DLPFC using a MagPro stimulator or Nexstim TMS device."
15975786|NCT03068702|Device|Optical Coherence Tomography Angiography|
15975787|NCT03068689|Procedure|RIPC|RIPC is delivered with a standard blood pressure cuff placed on the upper arm and another standard blood pressure cuff placed on the upper thigh. The cuffs are then simultaneously inflated to 200 mm HG and left inflated for 5 minutes, then deflated to 0 mmHG and left uninflated for 5 minutes. This cycle is repeated twice, so that the RIPC protocol takes 20 minutes in total. If the systolic blood pressure is > 185mm HG the cuffs are inflated to 15 mmHG above that level.
15975788|NCT03068689|Other|Placebo|Placebo
15975789|NCT03068676|Behavioral|Space from Depression|internet-delivered CBT
15975790|NCT03068676|Behavioral|Space from Anxiety|internet-delivered CBT
15975791|NCT03068663|Other|Sampling|Patients will receive their standard treatments, surgery with/without chemotherapy. A patient intervention consists in taking samples of blood, saliva, faeces, lung/tumour tissue, and bronchoalveolar lavage fluid.
15975792|NCT03068650|Biological|rindopepimut|Rindopepimut is an experimental cancer vaccine that may act to promote anti-cancer effects in patients who have glioblastoma multiforme (GBM) that expresses an EGFR mutation, called EGFRvIII. Data from, a randomized, controlled phase 2 study in patients with EGFRvIII positive progressive glioblastoma (the ReACT trial) suggested that vaccination with rindopepimut could improve survival. A randomized, controlled phase III study in patients with newly diagnosed EGFRvIII expressing GBM did not show a survival advantage from rindopepimut vaccination.
15975793|NCT03068637|Behavioral|Carevive CPS|This intervention will focus on the use of the Carevive CPS at the point of care to enable providers to deliver evidence-based and personalized supportive care and symptom management plans to their MM patients receiving active treatment. The Carevive CPS collects electronic patient reported outcomes (ePROs) and clinical data, reported and entered by clinical staff and/or extracted from the electronic medical record (EMR), and uses these to auto-generate the personalized care plans. Care plan content is driven by practice guidelines and other peer-reviewed evidence, and includes patient education, resources, and referrals developed by expert cancer clinicians and researchers.
15975794|NCT03068624|Biological|Aldesleukin|Given SC
15975800|NCT03068598|Device|PulseOn watch/Suunto Spartan Ultra watch|The Watch (PulseOn or Suunto Spartan Ultra) and a smartphone will be given to the patient after discharge. After a brief training on how to use the sleep tracker, patient will monitor his sleep with watch during the five nights following the discharge. All data will be transmitted directly to the smartphone. Each morning, the patient will complete a questionnaire to assess the quality of his sleep and on day 5, during a standart follow up visit, he will complete a questionnaire evaluating the acceptability of the sleep recording device.
15975801|NCT03068585|Drug|Neovasculgen (Cambiogeneplasmid)|treatment
15975802|NCT03068533|Other|8% L-Arginine/calcium carbonate containing toothpaste|use of 8% L-Arginine/calcium carbonate containing toothpaste to relieve hypersensitivity
15975803|NCT03068533|Other|use of strontium acetate toothpaste|use of strontium acetate toothpaste to relieve hypersensitivity
15975804|NCT03068520|Diagnostic Test|PET MR|PET MR with 18 Fluorodopa ([18F]-DOPA) will be performed on patient at set intervals
15975805|NCT03068507|Behavioral|Trimodal prehabilitation management|Trimodal prehabilitation strategy includes physical exercise (moderate aerobic exercise combined with resistance exercise and respiratory training ), nutritional suggestion and optimization（whey protein supplement）, and psychological therapy, as well as conventional guidance (including preoperative anesthesia assessment, drug treatment recommendations for chronic disease, quit smoking and abstinence).
15975806|NCT03068481|Drug|KDT-3594|Oral administration
15975807|NCT03068481|Drug|Placebo|Oral administration
15975808|NCT03068468|Drug|BIIB092|BIIB092 intravenous infusion on specified days
15975809|NCT03068468|Drug|Placebo|Placebo intravenous infusion on specified days
15975810|NCT03068455|Biological|nivolumab|Specified Dose on Specified Days
15975811|NCT03068455|Biological|ipilimumab|Specified Dose on Specified Days
15975812|NCT03068442|Drug|Imaging with flutemetamol F 18 PET/CT|All subjects will undergo diagnostic imaging as the intervention. This imaging will be with flutemetamol F 18 PET/CT
15975813|NCT03068429|Drug|Sertraline Hydrochloride|first week: sertraline hydrochloride 50mg/day, second week: sertraline hydrochloride 100mg/day, third week: sertraline hydrochloride 150mg/day, fourth week: sertraline hydrochloride 200mg/day OBS.: Other SSRIs (fluoxetine, paroxetine, escitalopram) with equivalent dosage schedules can be used if patients report prior intolerance to sertraline
15975815|NCT03068403|Procedure|Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration|Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration
15975818|NCT03068377|Dietary Supplement|Experimental|Soft gel capsules containing a mixture of tomato extract, lutein, zeaxanthin as well as other phytonutrients and vitamins
15975819|NCT03068377|Dietary Supplement|Placebo|soft gel capsules without test material
15975820|NCT03068351|Drug|RO6870810|RO6870810 will be administered subcutaneously (SC) at ascending-dose levels (from 0.30 milligrams/kilogram [mg/kg] to 0.65 mg/kg). In Cycle 1, RO6870810 will be given on Day 1 (omitted on Day 2) and then every day from Day 3 through to Day 15. Starting at Cycle 2, it will be given every day from Day 1 to Day 14 of each 21-day cycle. In the first combination therapy cohort RO6870810 will be administered at one dose-level below the maximum tolerated dose (MTD).
15975821|NCT03068351|Biological|daratumumab|Daratumumab will be administered intravenously (IV) at a dose of 16 milligrams/kilogram (mg/kg) of body weight weekly for the first 8 weeks, every two weeks for the following 16 weeks, and every four weeks thereafter, until disease progression.
15975822|NCT03068338|Device|Robotic Sock|Soft robotic actuator used in a sock design technology to perform plantarflexion and dorsiflexion of the foot about the ankle joint.
15975823|NCT03068338|Device|Intermittent pneumatic compression|Conventional device used by hospitals
15975824|NCT03068325|Other|TF-EAT|
15975825|NCT03068312|Drug|Ivacaftor|IVA 150 mg tablet.
15975826|NCT03068312|Drug|Placebo|Placebo matched to IVA tablet.
15975827|NCT03068299|Other|Dance|Sessions of sixty minutes each, which will take place weekly, totaling 24 weeks (6 months). Ten minutes from the start of each session will be reserved for initial exercises, with movements of the upper limbs, lower, accompanied by a motivational music. The process of identifying and memorizing the movements will be carried out as many times as the group deems necessary. The rhythms include combinations of circular and ballroom dances, including waltz, cha-cha-cha, cancan, among others. In all the sessions, the last fifteen minutes are reserved for a conversation about the dance learned/practiced in the day. It is expected to have reached the proposal of a practice of 15 different choreographies and that this was a pleasant moment for all the participants.
15975828|NCT03068299|Other|Health care guidance|Control group will receive attention, through guidelines for care and health practices for the caregiver and the elderly care recipient. This attention should occur in the same number of sessions of the dance and group intervention group. The control group should follow the same subdivision of the intervention group, in terms of the number of participants per subgroup. The subjects of the guidelines will be raised by the demand of the participants themselves and then worked in an interdisciplinary way.
15975829|NCT03068286|Behavioral|Space in Diabetes|The SilverCloud interventions comprise of 8 modules of evidence-based CBT which have been tailored. Psychoeducational content in the diabetes programme focusses on the impact that mood can have on self-management and self-care when living with diabetes.
15975830|NCT03068286|Behavioral|Space in COPD|The SilverCloud interventions comprise of 8 modules of evidence-based CBT which have been tailored.Additional content on panic has been included in the COPD programme. Symptoms of COPD and anxiety can be closely linked, and this content provides CBT-based strategies for dealing with symptoms of panic and anxiety.
15975831|NCT03068286|Behavioral|Space in Chronic Pain|"The SilverCloud interventions comprise of 8 modules of evidence-based CBT which have been tailored. A module on health anxiety, titled Anxiety and your Health, has been added to the chronic pain programme. This module provides psychoeducational content on health anxiety, the unhelpful behaviours that accompany it and how these can negatively impact on the experience of pain."
15975832|NCT03068273|Device|Real-time CGM data|
15975833|NCT03068260|Drug|Ropivacaine|30 ml ropivacaine 0,375% administered on each side as bilateral TQL blocks
15975838|NCT03068260|Drug|Morphine|intravenously administered morphine via PCA-pump
15975839|NCT03068260|Device|Patient-controlled analgesia|PCA-pump with IV-Morphine. 5 mg administered per bolus. Lock-out time and max. dosage standardized.
15975840|NCT03068247|Drug|Duloxetine|10 week treatment
15975841|NCT03068247|Drug|Placebo|10 week treatment
15975842|NCT03068234|Drug|Pirfenidone|A chemical synthesized agent showing anti-fibrotic effects in idiopathic pulmonary fibrosis.
15975843|NCT03068234|Drug|Placebo oral capsule|Placebo for pirfenidone capsule
15975844|NCT03068234|Drug|Steroids|Low dose of glucocorticoids, a basic treatment for patients with systemic sclerosis
15975845|NCT03068221|Other|anaerobic exercise|assessing anaerobic exercise status
15975846|NCT03068208|Procedure|Methylene blue-mediated photodynamic therapy|The 2% MB aqueous solution was applied to the lesion until saturation occurred, followed by a occlusive dressing and rest period of 30 minutes. After the rest period, the lesion was immediately illuminated with incoherent red light (peak emission spectrum at 630-640 nm)
15975847|NCT03068195|Procedure|microwave ablation|KY2000 microwave ablation system was used in the experimental group. A power output of 60 W for 1-3 min for 1-3 cycles to treat the renal cysts according to the cysts size and classification.Percutaneous microwave ablation will be performed under the guidance of ultrasound while the laparoscopic microwave ablation will be performed under direct vision
15975848|NCT03068195|Procedure|laparoscopic decortication|conventional laparoscopic decortication will be performed to treat the renal cysts
15975849|NCT03068182|Device|Arm crank|Each participant practiced on arm crank (Hudson) from long sitting position for 40 minutes. Seat's height and distance were adjusted to achieve full extension of subject arms at horizontal shoulder-level position
15975850|NCT03068182|Device|Treadmill|Participant practiced on an electronic computerized treadmill for 40 minutes . participant began warming up with lowest speed treadmill exercise for 5 minutes at zero inclination. Treadmill speed was increased gradually to achieve the pre-determined individualized moderate intensity for 30 minutes
15975851|NCT03068182|Other|Exercise|
15975852|NCT03068156|Radiation|308-nm excimer laser|monochromator UVB laser (308nm)
15975853|NCT03068130|Drug|Bardoxolone methyl|Capsules of Bardoxolone methyl
15975854|NCT03068117|Other|Regular Early Specialist Symptom Control Treatment (RESSCT)|"Participants will be seen within three weeks of randomisation by the Specialist Palliative Care Team (SPCT), (regardless of, and in addition to, all other treatments being offered). The initial meeting will be an approximately 1 hour consultation with a member of the Specialist Palliative Care team. This may be either a Consultant or Specialist Palliative Care Clinical Nurse Specialist (SPCCNS).
~Patients will then continue to be seen regularly on at least a 4 weekly basis (regardless of other treatments, interventions and symptoms) by a member of the SPCT, with consultations lasting approximately 30 minutes. These monthly reviews will continue until end of trial (EOT) or patient death."
15975855|NCT03068104|Other|No intervention|
15975856|NCT03068091|Device|Chest CT|Inspiration and expiration chest CT
15975857|NCT03068091|Diagnostic Test|Pulmonary Function Testing|Measure lung function
15975858|NCT03068078|Dietary Supplement|Low carbohydrate diet high in monounsaturated fats|Participants will have to change their diet during 6 months
15975859|NCT03068065|Drug|Liraglutide|the dosage of liraglutide was 0.6 mg/day during the first week, 1.2 mg/day during the second week, and 1.8 mg/day from the third week to the conclusion of the study
15975860|NCT03068065|Drug|Metformin|the dosage of metformin was 250 mg thrice a day during the first week, 500 mg thrice a day during the second week, and 1000 mg twice a day from the third week to the conclusion of the study
15975861|NCT03068065|Drug|Gliclazide|the initial dosage of gliclazide was 30 mg before breakfast, which was gradually titrated to a maximum of 120 mg/day to achieve a fasting capillary plasma glucose of <7.0 mmol/L
15975862|NCT03068052|Behavioral|No incentive|Each participant will receive an email describing the importance of colorectal cancer screening and that they have been selected to receive a risk assessment. They will directed to an online platform where they will be asked about age, family history, and prior screening history. Those who are eligible for screening will be offered the VIP access phone number to schedule an appointment.
15975863|NCT03068052|Behavioral|Incentive|Each participant will receive an email describing the importance of colorectal cancer screening and that they have been selected to receive a risk assessment, for which they will received a loss-framed incentive. They will directed to an online platform where they will be asked about age, family history, and prior screening history. Those who are eligible for screening will be offered the VIP access phone number to schedule an appointment and will receive an additional unconditional pro-social incentive.
15975864|NCT03068039|Other|Oats breakfast porridge|Isoenergetic and isovolumteric oats breakfast porridge
15975865|NCT03068039|Other|Pearl (bajra) breakfast porridge|Isoenergetic and isovolumteric pearl (bajra) breakfast porridge
15975866|NCT03068026|Device|VitaBreath|The VitaBreath devise will be applied during the 1st minute of each resting period between exercise bouts and during the 1st minute of recovery.
15975867|NCT03068026|Other|Pursed Lip Breathing technique|Pursed Lip Breathing technique will be applied during the 1st minute of each resting period between exercise bouts and during the 1st minute of recovery.
15975868|NCT03068013|Behavioral|CALM|CALM intervention covers four domains, namely: 1) Symptom management and communication with health care providers; 2) Changes in self and relations with close others, 3) Spiritual well-being, sense of meaning and purpose, 4) Preparing for the future, sustaining hope and facing mortality
15975869|NCT03068013|Behavioral|SPI|Active Comparator: Supportive psycho-oncology intervention Supportive psycho-oncology intervention (SPI) includes counseling, psychoeducation and crisis intervention, which is the usual care intervention provided in our centres.
15975870|NCT03068000|Behavioral|Judo Training|Judo intervention is divided into general exercises: warm-up and stretching specific to the sport; Specific exercises of the sport: shock absorption, falls cushioning (Ukemi-waza), immobilization techniques (hon-kesa-gatame and tate-shiho-gatame) and projection (o-soto-gari, o-goshi, ashi-guruma, koshi-guruma, tai-otoshi and others); And fight simulation: randori.
15975871|NCT03068000|Behavioral|Ball Games|The Ball Games is divided into general exercises: heating and specific stretching with ball; Specific exercises of the sport: fundamentals of sports with ball, exercises with ball; And games: games will be given at the end of the lesson to work out all the fundamentals and specific exercises in general.
15975872|NCT03067987|Device|Low Intensity Linear Shockwave Device for the Treatment of Erectile Dysfunction.|"This is a prospective, randomized, clinical study aimed to evaluate the safety and efficacy of the two treatment schedules on symptomatic erectile dysfunction patients. The patients are randomized in a 1:1 ratio into two active treatment groups.
~Group A: 5 daily sessions within a week (Monday, Tuesday, Wednesday, Thursday, Friday), in which 720 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura).
~Group B: Three sessions per week (Monday, Wednesday, Friday) for 2 consecutive weeks, in which 600 shocks of treatment energy will be applied in every session to each treated region (left and right corpora cavernosa and crura)
~."
15975873|NCT03067974|Drug|Ketamine Hcl 100Mg/Ml Inj|10mg/kg of Ketamine Hcl 100Mg/Ml Inj to be administered intranasally for pediatric procedural sedation
15975874|NCT03067961|Other|Salmonella Typhi (S. Typhi)|Investigating the role of typhoid toxin in the pathogenesis of enteric fever
15975875|NCT03067948|Behavioral|Patient Designated Positive Screen Shared with Provider|Patient Designated Positive Screen Shared with Provider -- In the intervention, participants will be given the opportunity to determine which positive screen, if any, that the participant would like to discuss with the participant's provider at the next HIV primary care appointment. The participant will be notified that all positive screens will be shared with the provider prior to their next HIV primary care visit, and that any positive screen the patient has chosen to discuss with the provider will be specified. The provider will receive the PROs result (score, interpretation, and recommendation) prior to their next HIV primary care visit
15975876|NCT03067935|Drug|glembatumumab vedotin|
15975877|NCT03067922|Other|Non interventional study|Not applicable. No intervention will be done. it is an observational study assessing pain after mastectomy and the quality of life as assessed from validated questionnaires given to the patients at regular intervals
15975878|NCT03067909|Other|CIED surgery|
15975879|NCT03067896|Drug|Bupivacaine|Patients will receive intrathecal hyperbaric bupivacaine 12.5 mg in 2.5 ml
15975880|NCT03067896|Drug|Dexmedetomidine|Patients will receive intrathecal hyperbaric bupivacaine 10 mg in 2 ml with dexmdetomidine 5 µg in 0.5 ml normal saline
15975881|NCT03067896|Drug|Magnesium Sulfate|Patients will receive intrathecal hyperbaric bupivacaine 10 mg in 2 ml magnesium sulfate 50 mg in 0.5 ml normal saline
15975882|NCT03067883|Drug|Ombitasvir, Paritaprevir and Ritonavir|"A total of 40 HCV treatment naïve patients with or without compensated cirrhosis on regular hemodialysis will be enrolled in the study.
~These patients will receive an intervention of '25 mg ombitasvir, 150 mg paritaprevir, and 100 mg ritonavir' (2 capsules Qurevo®) plus ribavirin 200 mg daily for 12 weeks.
~Qurevo will be given once daily (on the day of dialysis, it will be given after dialysis session).
~Ribavirin will be given once daily (on the day of dialysis, it will be given 4 hrs before dialysis session )."
15975883|NCT03067870|Biological|Stem Cell Transplantation|"Intravenous administration of autologous bone marrow derived stem cells for immunomodulation.
~Transplantation of autologous bone marrow derived stem cells in joints."
15975884|NCT03067857|Biological|Stem Cells|Autologous bone marrow-derived stem cell populations injected via the intravenous and intrathecal routes.
15975885|NCT03067844|Drug|Alirocumab|Pre-filled auto-injector pen every second week, starting at day 1 and up to week 50
15975886|NCT03067831|Biological|Stem Cells|Transplantation of purified autologous bone marrow-derived stem cells.
15975887|NCT03067818|Procedure|Unaffected Transcranial Magnetic Stimulation|Non-invasive brain stimulation to unaffected hemisphere site prior to practice
15975888|NCT03067818|Procedure|Affected Transcranial Magnetic Stimulation|Non-invasive brain stimulation to affected hemisphere site prior to practice
15975889|NCT03067818|Procedure|Control Transcranial Magnetic Stimulation|Non-invasive brain stimulation to control site prior to practice
15975890|NCT03067805|Behavioral|Sexual Infidelity Condition|
15975891|NCT03067805|Behavioral|Emotional Infidelity Condition|
15975892|NCT03067805|Behavioral|Neutral Condition|
15975893|NCT03067805|Behavioral|Player in Jealousy Condition|
15975894|NCT03067805|Behavioral|Player in Non-Jealousy Condition|
15975895|NCT03067792|Drug|5-fluorouracil, irinotecan and leucovorin|In FOLFIRI group, patients received irinotecan 180 mg/m2 and 5-fluorouracil 400mg/m2 intravenously bolus injection on days 1 and leucovorin 200mg/m2 for 2 hours and 5-fluorouracil 600mg/m2 for 22 hours intravenously infusion on day 2 of a 14-day cycle.
15975896|NCT03067792|Drug|docetaxel and cisplatin|In DP group, patients received docetaxel 75 mg/m2 and cisplatin 75mg/m2 intravenously on days 1 of a 21-day cycle.
15975897|NCT03067779|Other|mHealth Tool|"The curriculum in the mHealth tool was derived in consultation with patient safety, informatics and adult educational curricula experts, and is comprised of clinical vignettes describing common patient safety themes in CKD and includes a pre- and post-test knowledge assessment. Topics of emphasis included NSAID risk awareness, hypoglycemia awareness, avoidance of volume depletion when ill (Sick Day Protocol) and avoidance of contrast-induced nephropathy."
15975898|NCT03067766|Procedure|Art Therapy|Participate in a comic art creation workshop
15975899|NCT03067766|Other|Interview|Undergo qualitative interviews
15975900|NCT03067766|Procedure|Quality-of-Life Assessment|Ancillary studies
15975901|NCT03067766|Other|Questionnaire Administration|Ancillary studies
15975902|NCT03067753|Drug|Monosialoganglioside Ganglioside|Monosialoganglioside ganglioside was given at 100 mg/time, once a day for 2 months.
15975903|NCT03067753|Drug|Methylprednisolone (Steroid Hormone)|Pulse steroid, methylprednisolone, was administered by intravenous infusion over 3 consecutive days. Three grams of methylprednisolone was given in each cycle. Administration of 1 g was infused over 1 h daily for 3 days on an in-patient basis, which then tailed off in 10 days with administration of oral prednisolone.
15975904|NCT03067753|Drug|Prednisolone|
15975905|NCT03067740|Drug|Bupivacaine|intraperitoneal instillation of bupivacaine 0.25% ( 2mg/kg) after excision of the appendix.
15975906|NCT03067740|Drug|Dexmedetomidine|intraperitoneal instillation of bupivacaine 0.25% ( 2mg/kg) plus dexmedetomidine 1mcg/kg after excision of the appendix.
15975907|NCT03067727|Drug|Dinoprostone|The DVI contains 10 mg Dinoprostone
15975908|NCT03067727|Drug|Placebo|The placebo product is identical with the active product except that it does not contain Dinoprostone.
15975909|NCT03067714|Other|Infant formula with added synbiotics|Intervention group: Infant Formula / Follow-On formula with partially hydrolysed cow's milk protein supplemented with prebiotics and probiotics.
15975910|NCT03067714|Other|Standard infant formula|Control group: Standard Infant Formula / Follow-On formula with intact cow's milk protein (only standard ingredients, without addition of pre- and probiotics).
15975911|NCT03067701|Drug|Carbon Monoxide|In healthy young adults 18-39 years of age, The investigator will determine if intermittent inhalation of 0.1% CO, from a 1-Liter bag once every minute for 30-40 min at a level that approaches the CO boost with hookah smoking, augments endothelial function.
15975912|NCT03067688|Drug|Temisartan+Amlodipine+Rosuvastatin (Combination drug)|PO, Once daily(QD), 8weeks
15975913|NCT03067688|Drug|Temisartan+Amlodipine|PO, Once daily(QD), 8weeks
15975914|NCT03067688|Drug|Temisartan+Rosuvastatin|PO, Once daily(QD), 8weeks
15975915|NCT03067675|Device|Topcon DRI OCT Triton (plus)|OCT Machine used for diagnostic purposes
15975916|NCT03067662|Other|Aerobic exercise|
15975917|NCT03067649|Behavioral|Motivational Interview|90-minute interview to discuss their concerns and possible barriers to seeking treatment for themselves
15975918|NCT03067649|Behavioral|Information only control|Participants are provided with a pamphlet containing referral information
15975919|NCT03067636|Behavioral|Physical Exercise|Physical exercise: Amount of time exercising gradually titrated from 90-minutes in week one to 180-minutes in week eight. Intensity titrated concurrently from 40 - 60% VO2 max in week one to 40 - 90% VO2 max in week eight. Eight week gym membership provided to all participants to facilitate engagement in exercise.
15975920|NCT03067636|Behavioral|Stress management training A|Stress management training A: Daily stress management training for eight weeks with training activity delivered via app. Session lengths titrated from 10-minutes per day in the first week to 20-minutes per day in week eight.
15975921|NCT03067636|Behavioral|Stress management training B|Stress management training B: Daily stress management training for eight weeks with training activity delivered via app. Session lengths titrated from 10-minutes per day in the first week to 20-minutes per day in week eight.
15975922|NCT03067623|Drug|PRP|PRP intrauterine infusion
15975923|NCT03067623|Device|Tomcat catheter|PRP intrauterine infusion by means Tomcat catheter
15975924|NCT03067610|Radiation|Intensity Modulated Radiation Therapy|The radiotherapy plan wil be delivered in 2 sequential courses. The first course involves 20 fractions of 2 Gy per fraction to the entire volume (gross disease and elective). The second course involves 15 fractions (thus, total of 35 fractions), at either 2 Gy (gross disease) or 1.6 Gy (microscopic disease and suspicious node) per fraction.
15975925|NCT03067610|Drug|chemotherapy|chemotherapy (if given, either cisplatin, cetuximab, or carboplatin-paclitaxel) per physician discretion
15975926|NCT03067597|Drug|Dinoprostone|The DVI contains 10 mg dinoprostone
15975927|NCT03067571|Biological|Daratumumab|Given IV
15975928|NCT03067558|Diagnostic Test|Children's automated respiratory rate monitor|"The Children's Respiration Monitor system comprises of an accelerometer based device, with a belt to attach the device to the child.
~The device measures the respiration rate in children under 5 years old and automatically classifies the breathing rate according to the IMNCI guidelines set by the World Health Organization. The device is intended to be used by health workers at the community level in low resource settings, clinical officers, nurses, midwives, clinicians (Professional Health Workers) at primary or secondary care facilities."
15975929|NCT03067558|Diagnostic Test|MK2 Acute Respiratory Infection (ARI) Timer|The MK2 ARI timer is a manual respiratory rate (RR) counting device used to assist frontline health workers in measuring the length of time to count the RR in children. It is the second generation of ARI timers (succeeding MK1 ARI timer). The ARI timer is the standard practice for measuring and classifying RR at community level.
15975930|NCT03067545|Other|Step rate increase|increase the step rate during running by 10% steps per minute
15975931|NCT03067532|Procedure|existed simulation system user|Investigator will divide the subject by the two groups. Each group will take about 15 minutes for exercising drive robotic surgery instrument by each simulation system. After 15 minutes, both group will take an short exam to check the ability to manage the robotic surgery instrument.
15975932|NCT03067532|Procedure|home made simulator user|Investigator will divide the subject by the two groups. Each group will take about 15 minutes for exercising drive robotic surgery instrument by each simulation system. After 15 minutes, both group will take an short exam to check the ability to manage the robotic surgery instrument.
15975933|NCT03067519|Other|Fast track surgery|early feeding and mobilization after surgery
15975934|NCT03067519|Other|Conventional management|Management per the primary surgeon
15975935|NCT03067506|Other|No intervention|No intervention
15975936|NCT03067493|Biological|Neo-MASCT|Patients assigned to Neo-MASCT treatment will receive 18 cycles of neo-MASCT (6 courses), with one cycle every month for the first year and one cycle every 2 months for the second year. Each cycle includes one DCs subcutaneous injection and one CTLs infusion.
15975937|NCT03067480|Device|iPro2 Professional CGM|Professional CGM measures interstitial glucose every 5 minutes via a glucose-oxidase-impregnated membrane during a 3 day period. The patient wearing professional CGM is blinded to the repeated measurements and the data is stored for retrospective analysis.
15975938|NCT03067467|Drug|Hyperpolarized 13C-Pyruvate|Hyperpolarized 13C-pyruvate IV bolus followed by brain MRSI.
15975939|NCT03067467|Drug|Gadolinium|Brain MRI performed with and without gadolinium-based contrast.
15975940|NCT03067454|Procedure|Early mobilisation|"Conservative treatment with early mobilisation
~The patient is instructed to do a fist and is not allowed to leave the clinic before. Active mobilisation under control (doctor or physiotherapist) is performed until healing of the fracture is documented."
15975941|NCT03067454|Procedure|Operation|Operation of the fracture. Usually open reduction and internal fixation with plates and screws or just screws within 2 weeks of injury. Immobilisation in a cast for two weeks followed by physiotherapy.
15975942|NCT03067441|Drug|bempedoic acid|bempedoic acid 180 mg tablets taken orally, once per day.
15975943|NCT03067428|Dietary Supplement|Glucose|Participants will adhere to a fructose restricted diet for a period of six weeks (<7.5 grams/meal and/or <10 grams/day; ad-libitum intake). In addition, the amount of fructose that will be restricted - which is based on the average individual fructose intake assessed prior to randomization - will be supplemented as glucose powder three times daily during the meal.
15976025|NCT03066843|Drug|ALA (5-aminolevulinic acid)|ALA (5-aminolevulinic acid) will be applied to subjects' skin for either zero time incubation or one hour incubation
15975944|NCT03067428|Dietary Supplement|Fructose|Participants will adhere to a fructose restricted diet for a period of six weeks (<7.5 grams/meal and/or <10 grams/day; ad-libitum intake). In addition, the amount of fructose that will be restricted - which is based on the average individual fructose intake assessed prior to randomization - will be supplemented as fructose powder three times daily during the meal.
15975945|NCT03067415|Drug|D565H(Latanoprost 25㎍/㎖)|D565H twice daily
15975946|NCT03067415|Drug|D565(Latanoprost 50㎍/㎖)|D565 once daily
15975947|NCT03067402|Other|Observation|Patient receives standard observation i.e. only do a nuclear imaging stress test if symptoms present themselves over the course of 3 years
15975948|NCT03067402|Diagnostic Test|Nuclear Perfusion Imaging Stress Test|Patient receives routine nuclear image perfusion stress test
15975949|NCT03067389|Diagnostic Test|Diagnostic test|Genetic diagnostic test
15975950|NCT03067376|Drug|[14C]-CORT125134|
15975951|NCT03067363|Drug|MOR107|MOR107 solution for injection
15975952|NCT03067363|Drug|Placebo|Solution for injection manufactured to match MOR107 solution for injection
15975953|NCT03067363|Other|Low sodium diet|Diet designed to restrict sodium intake to 40 mmol/day
15975954|NCT03067337|Device|Stainless Steel Crown (Group A)|Full coverage restoration for multi-surface carious teeth
15975955|NCT03067337|Device|NuSmile Zirconia Crowns (Group B)|Full coverage restoration for multi-surface carious teeth
15975956|NCT03067311|Behavioral|I-CAT|I-CAT is a novel therapeutic intervention combining mindfulness and meditation strategies to improve stress reactivity and increase meaningful coping, as well as a range of possible proximal (e.g. autonomic, endocrine, immune indices of stress reactivity, symptom severity) and distal measures (function, relapse, quality of life).
15975957|NCT03067311|Behavioral|Treatment as Usual|Treatment as usual defined by participant clinician at OASIS clinic.
15975958|NCT03067285|Drug|ELV/COBI/FTC/TAF|Treatment with ELV/COBI/FTC/TAF during 24 weeks since randomized.
15975959|NCT03067285|Drug|DTG/3TC/ABC + ELV/COBI/FTC/TAF|Patients continuing on treatment with DTG/3TC/ABC after the randomization for 4 weeks, and then switch to ELV/COBI/FTC/TAF for 24 weeks
15975960|NCT03067272|Device|FemBloc® Permanent Contraceptive System|The FemBloc Permanent Contraceptive System consists of treatment with a Delivery System and Biopolymer, and a confirmation test with the FemChec® Tubal Occlusion Confirmation device as part of a sonographic hysterosalpingogram (Sono HSG).
15975961|NCT03067259|Other|Exposure Group|Surgeries of high or low impact. They could be local , regional o general anesthesia; sedation or a combination of both.
15975962|NCT03067246|Device|VBM Intubating Laryngeal Tube|The position of the VBM Intubating Laryngeal Tube will be assessed using a fibreoptic scope following balloon inflation of the cuff. Seal pressure will be assessed with the presence of the inflated cuff. Endotracheal intubation through the intubating laryngeal tube with a size 7 VBM reinforced tube will be assessed using a fiberoptic scope.
15975963|NCT03067246|Device|I-Gel|The position of the I-Gel will be assessed using a fibreoptic scope. The seal pressure will be assessed with the specified design of the I-Gel in the absence of a cuff. Endotracheal intubation through the I-Gel with a size 7 reinforced endotracheal tube will be assessed using a fiberoptic scope.
15975964|NCT03067233|Other|Polysomnography|Complete polysomnography with : Electroencephalogry, electro-oculography, surface electromyography (chin muscle, anterior tibial muscles), nasal pressure, respiratory movements (plethysmography of thoracic and abdominal inductance), pulse oximetry and electrocardiography.
15975965|NCT03067220|Other|Virtual outpatient clinic appointment|Patients will be sent an appointment letter stating a specific day approximately 6 weeks after their discharge from hospital in which they will be contacted by telephone for a review by a junior doctor from the discharging team.
15975966|NCT03067220|Other|Standard outpatient clinic appointment|Patients will be sent an appointment letter to return to a scheduled outpatient clinic for review approximately 6 weeks after their discharge from hospital
15975967|NCT03067207|Behavioral|MARS-A|The intervention will consist of the 8-week mindfulness meditation program designed for adolescents with chronic health conditions.MARS-A is based on two established mindfulness-based interventions for adults: MBSR and MBCT. The content of the program will be the same for in-person and e-health groups: all participants will receive eight 90-minute weekly evening sessions led by two trained and experienced mindfulness providers. Sessions will include short meditation practices, breathing exercises, guided discussion, mindful movements and inquiry, adapted to the context of chronic illness. Every session will start with a brief review of home practice and will close with a discussion of the home practice for the following week.
15975968|NCT03067194|Drug|Celecoxib 100 MG|Celecoxib 100mg, Oral, BID(twice per day), During 6 weeks
15975969|NCT03067194|Drug|Celecoxib 200mg|Celecoxib 200mg, Oral, QD(once daily), During 6 weeks
15975981|NCT03067168|Drug|Bupivacaine|5 mL of 0.5% bupivacaine will be injected into 2 locations bilaterally.
15975982|NCT03067168|Drug|normal saline 0.9%|5 mL of 0.9% normal saline will be injected into 2 locations bilaterally.
15975983|NCT03067155|Genetic|CMV-specific T cells|
15975984|NCT03067155|Drug|Standard anti-viral therapy|Continue with the anti-viral treatment as per standard of care.
15975985|NCT03067142|Other|Observational|Not an interventional study. Analyses of previously collected urine specimens and data on estimated kidney filtering function.
15975986|NCT03067129|Drug|Glecaprevir/pibrentasvir adult formulation|Film-coated tablet (100 mg/40 mg)
15975987|NCT03067129|Drug|Glecaprevir/pibrentasvir pediatric formulation|Film-coated pellets/granules (15.67%/8.25%)
15976026|NCT03066843|Device|Blue light therapy|Subjects will be exposed to blue light
15975988|NCT03067116|Diagnostic Test|Posturography Evaluation|Posturography testing using the modified Clinical Testing of Sensory Integration in Balance (mCTSIB) protocol: the subjects will be required to stand on a hard or compliant surface in a comfortable posture, with eyes open or closed
15975989|NCT03067116|Diagnostic Test|Anthropometrics|measurement of height, minimum stance width (feet together or as close as they can be), circumference of the torso at the breast level, of the abdomen, of the hip, and of each thigh, and supine fundal height
15975990|NCT03067116|Diagnostic Test|Vitals|measurement (bilateral and seated/standing if applicable) of temperature, respiration rate, heart rate, blood pressure, pulse oxygenation and heart rate variability
15975991|NCT03067116|Other|Health and daily activity questionnaires|one time general health questionnaire as well as session questionnaires asking the subjects if they have fallen since their last testing session and how comfortable they are in doing daily activities
15975992|NCT03067103|Drug|Tramadol|Patients will receive injections in peritonsillar fossa of tramadol (2 mg/kg-2 ml)
15975993|NCT03067103|Drug|Ketamine|Patients will receive injections in peritonsillar fossa of ketamine prior to surgery
15975994|NCT03067103|Drug|Placebos|Patients will receive 2mL of saline solution in peritonsillar fossa prior to surgery
15975995|NCT03067090|Device|Aquamid Reconstruction|"AR contains 2.5% polyacrylamide and 97.5% non-pyrogenic water, with a unique molecular structure that allows the normal water exchange with the surrounding tissue without losing shape or effect. AR is biocompatible, non-biodegradable, stable and sterile.
~The gel is provided in a sterile, pre-filled 1 ml sealed syringe. The gel is intended to be injected intra-articularly with a sterile 21G x 2 inch (0.8 x 50 mm) needle."
15975996|NCT03067077|Procedure|SMILE|SMILE surgery
15975997|NCT03067077|Procedure|LASIK|LASIK surgery
15975998|NCT03067064|Other|no intervention|Clinical examination
15975999|NCT03067051|Drug|Verteporfin|In the last decade a clinical interest of developing new methods for minimally invasive treatments of organ-confined prostatic malignancies has been pursued. In this study the drug verteporfin for injection (VFI) is to be used with the SpectraCure P18 System (Interstitial multiple diode lasers and IDOSE® Software).
15976000|NCT03067051|Device|SpectraCure P18 System|Interstitial Photodynamic therapy is provided with the the SpectraCure P18 system
15976001|NCT03067038|Device|Single incision laparoscopic cholecystectomy|Laparoscopic cholecystectomy with single port device
15976002|NCT03067038|Device|Three port laparoscopic cholecystectomy|Laparoscopic cholecystectomy with three port
15976003|NCT03067025|Device|Actigraphy|Actiwatch Spectrum Plus will be worn on the non-dominant wrist 24 hours/day for seven days. Actigraphy is a valid and reliable objective measure of sleep patterns, including sleep quality, duration, and timing when compared to polysomnography (PSG).
15976004|NCT03067012|Other|Oncometabolic reconstruction|The length of biliopancreatic limb is 50cm and the length of Roux limb is 100cm. (long limb uncut Roux-en-Y gastrojejunostomy) These limbs are longer than the conventional uncut Roux-en-Y reconstruction for gastric cancer patients.
15976005|NCT03066999|Procedure|Cystoscopy|Patients will assign to either Group Cystoscopy (catheter placement via cystoscopy)
15976006|NCT03066999|Device|DirectVision|Patients will assign to either Group DirectVision (catheter placement via DirectVision)
15976007|NCT03066986|Drug|Delta-inulin|Addition of adjuvant, delta-inulin to JJA VIT regime, to determine if this will allow lower doses and shorter regimes to promote protective responses, reducing costs and morbidity of JJA VIT.
15976008|NCT03066986|Biological|Dose finding comparison|"Define minimum effective maintenance dose (50mcg vs 25mcg). In real world sting challenges after 12 months of JJA VIT objective systemic reaction rates after 50 and 100 mcg maintenance doses respectively 14/130 and 12/126 subjects vs reaction rates to stings in similar subjects without JJA VIT 70-76%. Venom delivery in sting likely <20mcg. Therefore minimum effective maintenance dose not yet defined."
15976009|NCT03066973|Behavioral|BREATHING EXERCISE|The intervention group was instructed on breathing exercise according to the established trial protocol.
15976010|NCT03066960|Procedure|Radiofrequency neurotomy|RF neurotomy represents a nerve destructive, coagulating technique affecting the conduction through all nerve fibers.
15976011|NCT03066960|Procedure|Sham treatment|Sham treatment represents no coagulation of the nerve and will not affect the nerve conduction.
15976012|NCT03066947|Biological|SV-BR-1-GM|See above
15976013|NCT03066947|Drug|Cyclophosphamide|Low dose pre-treatment to reduce regulatory T cells
15976014|NCT03066947|Biological|Interferon-alpha-2b|Low dose given in the vaccine site to boost the immune response
15976015|NCT03066934|Other|noninvasive ventilation respiratory support|
15976016|NCT03066921|Dietary Supplement|Probiotic packet|Probiotic formulation will be given at a dose of one packet thrice daily for 24 weeks, amounting to a total of 300 billion colony forming units(CFU)/day. Each packet contains 100 billion viable lyophilized bacteria of three strains of Lactobacillus viz Lactococcus lactis subsp. Lactis LL358 (BCRC910699)、Lactobacillus salivarius LS159 (BCRC910700) and Lactobacillus pentosus and excipients.
15976017|NCT03066921|Dietary Supplement|Placebo|Placebo packet will be given at a dose of one sachet thrice daily for 24 weeks; Placebo packet contain all excipients as present in packets (without the 3 strains of bacteria as mentioned above).
15976018|NCT03066908|Device|Sinopsys® Lacrimal Stent|Transcaruncular paranasal sinus or nasal cavity access for the purpose of irrigating the ethmoid sinus with saline
15976019|NCT03066895|Device|BabyGentleStick|Experimental device.
15976020|NCT03066895|Device|Standard Lancing Device|HMC standard of care.
15976021|NCT03066882|Dietary Supplement|NCD|negative calorie diet
15976022|NCT03066882|Dietary Supplement|LCD|low calorie diet
15976023|NCT03066869|Drug|H.P. ACTHAR GEL|H.P. Acthar Gel is an adrenocorticotropic hormone (ACTH) analogue indicated for ophthalmic diseases.
15976024|NCT03066856|Other|Dietary intervention|"The main aim of the trial is to reduce serum levels of IGF-I and IRm with a a low- calorie and low-protein diet. In humans, calorie restriction alone does not seem to significantly lower IGF-I; protein restriction is also required. In detail, recommendations for participants included in the intervention arm include:
~reducing protein intake, mainly milk and animal protein (except fish), down to 10-12% of total calorie intake.
~reducing high glycemic index food and high insulinemic foods.
~reducing sources of saturated fat (red and processed meat, milk and dairy products).
~eating mostly food of plant origin, with a wide variety of seasonal products."
15976027|NCT03066830|Drug|Sotagliflozin (SAR439954)|"Pharmaceutical form: tablet
~Route of administration: oral"
15976028|NCT03066830|Drug|Placebo|"Pharmaceutical form: tablet
~Route of administration: oral"
15976029|NCT03066830|Drug|Metformin|"Pharmaceutical form: tablet
~Route of administration: oral"
15976030|NCT03066830|Drug|Sulfonylurea|"Pharmaceutical form: tablet
~Route of administration: oral"
15976031|NCT03066817|Drug|Ergocalciferol 8000 IU/ML Oral Liquid [DRISDOL]|50cc of ergocalciferol 8000 IU/ml will be given to participants as a one-time dose.
15976032|NCT03066817|Drug|Propylene Glycol|50cc of propylene glycole will be given to participants as one-time dose, used as placebo
15976033|NCT03066804|Drug|sacubitril/valsartan|Sacubitril/valsartan is available as 24 mg/26 mg, 49 mg/51 mg, 97 mg/103 mg, respectively in tablet form to be taken orally
15976034|NCT03066804|Drug|Enalapril|Enalapril is available as 2.5 mg, 5 mg, and 10 mg tablet form to be taken orally
15976035|NCT03066804|Drug|Valsartan|Valsartan is available as 40 mg, 80 mg, 160 mg tablet form to be taken orally
15976036|NCT03066804|Drug|Placebo to match sacubitril/valsartan|Placebo to match LCZ696 50 mg, 100 mg, 200 mg tablet form to be taken orally
15976037|NCT03066804|Drug|Placebo to match enalapril|Placebo to match enalapril 2.5 mg, 5 mg, 10 mg tablet form to be taken orally
15976038|NCT03066804|Drug|Placebo to match valsartan|Placebo to match valsartan 40 mg, 80 mg, 160 mg tablet form to be taken orally
15976039|NCT03066791|Dietary Supplement|Turmeric tablets|
15976040|NCT03066791|Dietary Supplement|Curcumin and Bioperine tablets|
15976041|NCT03066791|Dietary Supplement|Placebo tablets|
15976047|NCT03066765|Device|Linguaflex Tongue Retractor|Tongue implant
15976048|NCT03066739|Drug|Remifentanil|0.1 micrograms/kg/mL
15976049|NCT03066739|Drug|Remifentanil+ Placebo|high dose remifentanil (0.4 mg) combined with placebo (HI, 0.4 micrograms/kg/mL)
15976050|NCT03066739|Drug|Remifentanil +ultra-low dose naloxone|high dose remifentanil (0.4 mg) combined with ultra-low dose naloxone (HN, 0.004 micrograms/kg/mL naloxone
15976051|NCT03066713|Other|Skin Off French Fry|Skin Off French Fries will be provided at breakfast and lunch
15976052|NCT03066713|Other|Skin On French Fry|Skin On French Fries will be provided at breakfast and lunch
15976053|NCT03066713|Other|Hash brown|Hash brown potatoes will be provided at breakfast and lunch.
15976054|NCT03066713|Other|Carbohydrate control|A pancake will be provided at breakfast, and pretzels will be provided at lunch.
15976055|NCT03066700|Device|Hemostatic powder|HemosprayTM (Tc-325) is an endoscopic hemostatis powder that came onto market recently. It is made of an inorganic, non-absorbable powder which acts locally at the mucosa. When spraying the powder on to the bleeding site, it creates an adherent stable barrier sheath that allows for at least temporary hemostasis. Neither luminal nor systemic side effects have been reported to date.
15976056|NCT03066687|Drug|Erdafitinib|Erdafitinib 9 mg (provided as one 4-mg tablet [G-024] and one 5-mg tablet [G-025]) will be administered orally on Day 1 in each Treatment Period of assigned sequence.
15976057|NCT03066674|Other|McKenzie group|Mobilization for lumbar spine,TENS,Exercises,Postural education ,Home exercises program.
15976058|NCT03066674|Other|Control group|TENS,Exercises,Postural education ,Home exercises program.
15976059|NCT03066661|Drug|Entrectinib|Open-label expanded access, capsules
15976060|NCT03066648|Drug|Decitabine|Decitabine is a cytidine deoxynucleoside analogue that selectively inhibits DNA methyltransferases at low doses, resulting in gene promoter hypomethylation.
15976061|NCT03066648|Drug|PDR001|PDR001 is a high-affinity, ligand-blocking, humanized IgG4 monoclonal antibody directed against PD-1 that blocks the binding of PD-L1 and PD-L2.
15976062|NCT03066648|Drug|MBG453|MBG453 is a high-affinity, humanized anti-TIM-3 IgG4 monoclonal antibody which blocks the binding of TIM-3 to phosphatidylserine (PtdSer).
15976063|NCT03066648|Drug|Azacitidine|Azacitidine (5-azacytidine) is a cytidine nucleoside analogue that selectively inhibits DNA methyltransferases at low doses, resulting in gene promoter hypomethylation
15976064|NCT03066635|Drug|Botulinum Toxin Type A 25 IU|injection with 25 IU botulinum toxin towards the otic ganglion (symptomatic side) using image-guided navigation and the MultiGuide device
15976065|NCT03066635|Drug|Botulinum Toxin Type A 12.5 IU|injection with 12.5 IU botulinum toxin towards the otic ganglion (symptomatic side) using image-guided navigation and the MultiGuide device
15976066|NCT03066622|Drug|Standard of Care as per attending physician|Patients are randomized to standard of care medication (as determined by attending physician)
15976067|NCT03066622|Drug|5mg rapidly dissolving olanzapine|5mg rapidly dissolving olanzapine
15976068|NCT03066609|Drug|Secukinumab 150 mg s.c.|150 mg s.c. at randomization, Weeks 1, 2, 3, 4 and every 4 weeks till Week 48
15976069|NCT03066609|Drug|Secukinumab 300 mg s.c.|300 mg s.c. at randomization, Weeks 1, 2, 3, 4 and every 4 weeks till Week 48
15976070|NCT03066609|Drug|Placebo|Placebo 150 or 300 mg s.c at randomization, Weeks 1, 2, 3, 4, and 8. PASI responders at week 12 continued to receive placebo till Week 48. PASI non-responders at Week 12 received Secukinumab 300mg at Weeks 12, 13, 14, 15, 16 and every 4 weeks till Week 48
15976071|NCT03066596|Behavioral|PRAGMATIC|Provider educational seminar, EHR prompt, outreach-worker care coordination
15976072|NCT03066583|Biological|trephination with placebo|trephination under US guidance and placebo injection
15976073|NCT03066583|Biological|trephination with platelet rich plasma|trephination under US guidance and platelet rich plasma injection
15976074|NCT03066570|Behavioral|Graded Exposure|Graded Exposure in vivo (GEXP) is a second-generation cognitive-behavioural intervention, and is characterized by systematic and repeated exposure to feared movements, activities and/or sensations in order to decrease fear and subsequently increase physical activity.
15976075|NCT03066557|Procedure|TACE and Apatinib|TACE and Apatinib 250mg po qd
15976076|NCT03066557|Procedure|TACE|TACE
15976077|NCT03066544|Drug|Bupivacaine|Nerve blocks with bupivacaine will be performed at initial visit
15976078|NCT03066544|Drug|Naratriptan Pill|one pill will be administered twice each day for 5 days
15976079|NCT03066544|Drug|Dexamethasone|one tablet will be administered twice each day for 3 days
15976080|NCT03066544|Drug|Ketorolac|ketorolac will be administered intramuscularly (IM) or intravenously (IV) at initial visit
15976081|NCT03066531|Behavioral|ACT-based intervention|
15976082|NCT03066531|Behavioral|CBT-based intervention|
15976083|NCT03066518|Drug|Melatonin 5 mg|
15976084|NCT03066518|Other|Placebo|
15976085|NCT03066505|Device|Active MeRT Treatment|A personalized biometrics-guided protocol known as magnetic EEG/EKG resonance therapy (MeRT) treatment that is tailored specifically to each patient's higher harmonic frequency of heart rate, which is nearest to the characteristic frequency of alpha EEG frequency.
15976086|NCT03066505|Device|Sham MeRT Treatment|A personalized biometrics-guided protocol similar to MeRT treatment that mimics magnetic EEG/EKG resonance therapy (MeRT) but does not emit active stimulation.
15976087|NCT03066492|Other|Northwestern Follow Up Care Coordination|Each patient is provided with information by telephone and mail, offering assistance to receive a follow-up appointment at the Northwestern Transitional Care Follow Up Clinic.
15976088|NCT03066492|Other|Federally Qualified Health Center|Each patient is provided with information by telephone and mail, offering assistance to receive a follow-up appointment at a nearby Federally Qualified Health Center.
15976089|NCT03066479|Device|Fitbit|Wearable activity & sleep tracker.
15976090|NCT03066479|Other|OSA questionnaire|Parents will complete a questionnaire assessing the potential symptoms their child is experiencing that are related to obstructive sleep apnea (OSA).
15976091|NCT03066479|Diagnostic Test|Polysomnography|All participants will be undergoing a sleep study as part of their clinical care.
15976092|NCT03066466|Drug|Atorvastatin|Oral medication given to prevent graft versus host disease in bone marrow transplant.
15976093|NCT03066466|Drug|Methotrexate|IV medication given to prevent graft versus host disease in bone marrow transplant.
15976094|NCT03066466|Drug|Tacrolimus|IV or Oral medication given to prevent graft versus host disease in bone marrow transplant.
15976095|NCT03066453|Drug|Tobi Inhalant Product|inhaled tobramycin 300 mg twice per day
15976096|NCT03066453|Drug|Nebcin|10 to 12 mg/kg/day in 1 injection for adults and 10 to 15 mg/kg in 1 pediatric injection (combined with another IV antibiotic)
15976097|NCT03066440|Drug|Normal saline|All intravenous fluids used in the treatment of pediatric diabetic ketoacidosis will be based in normal saline for participants in the interventional arm instead of normal saline (as given to participants in the control arm).
15976098|NCT03066440|Drug|Lactated Ringers|All intravenous fluids used in the treatment of pediatric diabetic ketoacidosis will be based in lactated ringer's solution for participants in the interventional arm instead of normal saline (as given to participants in the control arm).
15976099|NCT03066427|Drug|Sunitinib|Sunitinib 50 mg/d
15976100|NCT03066414|Procedure|echography|The inferior vena cava and the internal jugular vein diameters were measured by echography before and after blood withdrawal during a standardized respiratory maneuver
15976101|NCT03066401|Procedure|echography|The inferior vena cava and the internal jugular vein diameters were measured by echography before and after blood withdrawal during a standardized respiratory maneuver
15976102|NCT03066388|Other|Pulse pressure variations|Stroke volume and, pulse pressure variations obtained by noninvasive (ΔPPCNAP) and invasive (ΔPPART) devices are recorded immediately before and after volume expansion (VE), performed as a 30-minute infusion of 500 mL of 4% gelatin.
15976103|NCT03066375|Device|Echocardiography-Doppler|Ultrasonographic recordings are recorded immediately before and after volume expansion (VE), performed as a 30-minute infusion of 500 mL of 4% gelatin. Inferior Vena Cava diameters are measured during spontaneous and standardized respiratory cycles. Stroke volume is measured during spontaneous respiratory cycles.
15976104|NCT03066362|Other|Echocardiography-Doppler|Ultrasonographic recordings are recorded immediately before and after volume expansion (VE), performed as a 30-minute infusion of 500 mL of 4% gelatin. Inferior Vena Cava diameters are measured during spontaneous and standardized respiratory cycles. Stroke volume is measured during spontaneous respiratory cycles.
15976105|NCT03066349|Other|Questionnaires|FertiQoL and HADS (Hospital Anxiety and Depression Scale) questionnaires
15976106|NCT03066336|Device|Erchonia LunulaLaser|Active Low Level Laser Light Therapy
15976107|NCT03066323|Other|Rice with tea extract|Rice with tea extract
15976108|NCT03066323|Other|Rice without tea extract|Rice without tea extract
15976109|NCT03066310|Diagnostic Test|Next generation sequencing|The obtained DNA from the urine, blood and tumor (optional) will be tested by next generation sequencing for each arm.
15976110|NCT03066297|Procedure|Extent of pulmonary resection|Extent of pulmonary resection selected based on the institutional decision-making algorithm
15976111|NCT03066271|Other|Exercise +|Usual care
15976112|NCT03066271|Other|Control +|Usual care
15976113|NCT03066258|Genetic|RGX-314|RGX-314 is a recombinant adeno-associated virus (AAV) gene therapy vector carrying a coding sequence for a soluble anti-VEGF protein
15976114|NCT03066245|Biological|MSC-PLGA|Bone marrow derived MSC seeded on biodegradable PLGA, supplemented with PL.
15976115|NCT03066219|Drug|BRM421|A topical solution of BRIM421 ophthalmic drops
15976116|NCT03066219|Drug|Placebo|vehicle ophthalmic drops
15976117|NCT03066206|Drug|Poziotinib|Given PO
15976118|NCT03066193|Drug|Dronabinol and Palmitoylethanolamide|Participants will receive Dronabinol which will be slowly titrated in the first week of the study. They will be followed for a total of 12 weeks; in addition, participants will receive the PEA in a standing dose of 400mg. They will be followed for a total of 12 weeks.
15976119|NCT03066180|Device|Viveve SUI treatment|Non-ablative radiofrequency treatment with surface cooling
15976120|NCT03066167|Other|Validation of different dysphagia scores|
15976121|NCT03066154|Drug|oral docetaxel (ModraDoc/r)|Weekly once- or twice daily ModraDoc/r
15976122|NCT03066154|Drug|androgen deprivation therapy|ADT according to the standard of care
15976123|NCT03066154|Radiation|high-dose intensity-modulated radiation therapy|77 Gy in 35 fractions of 2.2 Gy, 5 fractions a week
15976124|NCT03066128|Diagnostic Test|Point-of-care viral load testing|Point-of-care viral load testing will be performed while the participant is in the clinic to ensure that participants receive the viral load results on the same day
15976125|NCT03066128|Other|Lab-based viral load testing|Viral load testing will be lab based and follow standard of care procedures
15976126|NCT03066115|Drug|L-NMMA|See arm description.
15976127|NCT03066115|Drug|Ketorolac|See arm description.
15976128|NCT03066115|Drug|Ascorbic Acid|See arm description.
15976129|NCT03066115|Procedure|Intravenous Catheter|Two intravenous catheters will be placed for each study visit. One catheter will be used for the intravenous infusion of study drugs (L-NMMA, Ketorolac, and Ascorbic Acid). The second catheter will be used to draw intermittent blood samples at 8-specific time points throughout each study visit to ensure pharmaceutical efficacy and examine systemic physiologic blood variables of interest.
15976130|NCT03066115|Procedure|Transcranial Doppler Ultrasound|MCAv will be measured via the transtemporal window while BAv will be measured through the transforaminal window with 2-MHz transcranial Doppler ultrasound probes (TCD, Neurovision model 500M, Multigon Industries, Inc.; Yonkers, NY, USA)
15976131|NCT03066102|Other|muscle fatigue|"Modified push-up plus exercise:
~the participants first supported by both knees and the single elbow, and then performed sustained scapular protraction for three minutes with ten repetitions in males and two minutes with five repetitions in females with forty-five seconds rest between."
15976132|NCT03066089|Drug|Fenfuro|
15976133|NCT03066076|Drug|Antithyroid Drug|Antithyroid drug
15976134|NCT03066076|Procedure|Total thyroidectomy|Operation
15976135|NCT03066050|Other|MV Repair|Participants underwent mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.
15976136|NCT03066050|Other|MV Replacement|Participants underwent mitral valve replacement and complete preservation of the sub-valvular apparatus.
15976137|NCT03066050|Other|CABG|Participants underwent coronary artery bypass grafting
15976138|NCT03066037|Procedure|regional-anaesthesiological infiltration|Patients with therapy refractory chronic pain are treated with local infiltration techniques using e.g. local anaesthetics, opioids or drug combinations. Targeted structures are e.g. Ganglion stellatum, Ganglion pterygopallatinum, Trigeminal nerve branches (V1-V3). Patients receive a context- sensitive number of blocks in a series of infiltrations depenting on their pain course.
15976139|NCT03066011|Drug|Isavuconazonium sulfate|Oral and Intravenous
15976140|NCT03066011|Drug|Voriconazole|Oral and Intravenous
15976141|NCT03066011|Drug|Posaconazole|Oral and intravenous
15976142|NCT03065998|Drug|Opipramol|PO
15976143|NCT03065998|Drug|Baclofen|PO
15976144|NCT03065972|Procedure|Surgical fistula creation from patient's anatomy|Patient will be randomized via computer system, to receive the fistula or graft. If fistula, surgeon creates fistula for hemodialysis access from patient's anatomy.
15976145|NCT03065972|Device|Surgical Graft implant|Patient will be randomized via computer system, to receive the fistula or graft. If graft, surgeon implants hemodialysis access using an FDA approved graft.
15976146|NCT03065959|Drug|reldesemtiv|oral
15976147|NCT03065959|Drug|Placebo|oral
15976148|NCT03065946|Other|Early wakening|By using an intravascular device to administer mild TH for 24 hours, patients can safely have their medically induced coma reversed early at 12 hours, allowing an accurate neurological assessment to be performed
15976149|NCT03065933|Drug|extended-release clonidine|Subjects will received 0.2 mg extended-release clonidine twice on second day of this three-day study.
15976150|NCT03065907|Other|Vision rehabilitation|A service menu containing the minimum vision rehabilitation visits will be provided and assessed according to the participant's vision needs. Minimum vision rehabilitation visits include refraction, best-corrected visual acuity assessment, near vision, contrast sensitivity, central visual field test, education and consultation; rehabilitation visit will then be individualized.
15976151|NCT03065894|Other|Matched Physical Therapy Intervention|"Patients who are medium-risk will receive up to 6-8 physical therapy (PT) visits over a 3 month period that is guided by published evidence based practice guidelines. The PT treatment will be tailored to the physical findings and specific patient needs, and appropriate exercises, spinal mobilization/manipulation, strengthening/stretching as well as a home program will be given to improve patient pain and function and reduce disability.
~Patients who are high-risk will receive the evidence based PT treatment as deemed necessary. In addition, the PT treatment will incorporate principles of psychologically informed practice to address psychosocial barriers (e.g., fear avoidance, anxiety, etc) that may be impeding disability reduction. This may include instruction on chronic pain rehabilitation techniques such as the use of: pacing in order to maintain or increase activity; graded activity principles in order to increase function; and pain education and understanding responses to pain."
15976152|NCT03065894|Other|Current Care in Family Medicine|Patient education, medication management
15976153|NCT03065881|Device|RETeval|The RETeval device measures the retina's electrical response to light, called an electroretinogram (ERG). The standards body ISCEV [1] recommends collecting normative data for ERGs to provide waveforms and statistically relevant measurements representing the range of ERGs from people with normal vision. LKC Technologies provides this information with their UTAS product line and wishes to collect such a database for the newest device: the RETeval device. As the RETeval device uses a different electrode to measure the ERG, the normal data for the UTAS product line is not transferable to the RETeval device. Ophthalmic practitioners would also like ERG examples of specific retinal disorders to help diagnose patients with abnormal ERGs. The RETeval device is FDA cleared (K142567),
15976154|NCT03065868|Drug|H. pylori eradication (Amoxaxillin, Lanston, Clarithromycin)|H. pylori eradication (Triple Therapy) as first line treatment if eradication failure, quadruple therpy will be provided as 2nd line treatment
15976155|NCT03065855|Procedure|Early removal group|Participants assigned to the experimental arm will have their urethral catheters removed at 2 days after after laparoscopic anterior resection of the rectum.
15976156|NCT03065855|Procedure|Normal removal group|Participants assigned to the control group will have their urethral catheters removed at 7days following surgery, as is standard practice in our institution.
15976189|NCT03065582|Other|Topical Product A|topical application sunscreen containing topical antioxidants and sunscreen filters
15976190|NCT03065582|Other|Topical Product B|topical application of product A without topical antioxidants
15976157|NCT03065842|Behavioral|Abortion- and contraceptive-use stigma reduction program|"An abortion- and contraceptive-use stigma reduction intervention (3-weeks), capturing i. Negative stereotypes associated with girls who have had an abortion. ii. Discrimination/exclusion of girls who have had an abortion. iii. Fear of coming in contact with a girls who have had an abortion. iv. Negative stereotypes about girls using a contraceptive method. v. Misconceptions about contraceptive use.
~The pedagogy will be based on that gender stereotypes, intent to control female sexuality, compulsory motherhood, are social constructs that can be deconstructed. Pedagogical methods will include role modelling, practice of desired behaviours, activities for building self-efficacy, and didactic instructions."
15976158|NCT03065842|Behavioral|Usual Standards|Usual standards according to the school curriculum in Kenya.
15976159|NCT03065829|Behavioral|ASSIST|Wearable sensor technology delivering mindfulness meditation training (MMT) and health promotion (sleep hygiene and physical activity) .
15976160|NCT03065829|Behavioral|Attention-Control|Wearable sensor technology only viewing biophysical sensor data.
15976161|NCT03065816|Drug|Z0063|Pharmaceutical form: chewable tablets Route of administration: oral
15976162|NCT03065816|Drug|Gaviscon|Pharmaceutical form: chewable tablets Route of administration: oral
15976163|NCT03065803|Procedure|Buccal plate expansion technique for dental socket preservation|"An internal osteotomy of the socket buccal plate will be performed with a piezotome (SurgyStar).
~Two vertical osteotomies and one horizontal osteotomy will be made to push the buccal plate outward from the socket. Two small cervical releasing incisions will be made in the mesiobuccal and distobuccal aspects of the socket to permit the displacement of the osteotomies in the area of keratinized tissue. The socket will be loaded with natural bovine bone mineral (cerabone). The biomaterial will be pressed to push the released buccal plate outward. A collagen bio absorbable membrane will be utilized to cover the socket. The collagen membrane plug will be stabilized on the top of the socket with a cross suture (silk 4/0)."
15976164|NCT03065803|Procedure|Guided bone regeneration technique for post-extraction dental socket preservation|After full-thickness flap reflection on buccal and lingual sides, atraumatic tooth extraction utilizing periotome will be performed.The periosteum of buccal flap will be incised; this would permit coronal advancement of facial flap and a tension-free primary closure. Extraction sockets will be grafted with natural bovine bone mineral (cerabone). Collagen membrane will be trimmed and placed on the grafted socket and alveolar bone.. Buccal and lingual/palatal flaps will be approximated utilizing interrupted simple loop and vertical mattress sutures (4/0)
15976165|NCT03065790|Diagnostic Test|2-Deoxy-2-[18F]fluoro-D-glucose (FDG)|2-Deoxy-2-[18F]fluoro-D-glucose (FDG)
15976166|NCT03065777|Device|ONE ENDO|single file rotary system
15976167|NCT03065777|Device|F6 SKYTaper|single file rotary system
15976168|NCT03065777|Device|ProTaper Universal|multi-file rotary system
15976169|NCT03065764|Drug|89Zr-Pembrolizumab|"eligible subjects will undergo two whole body immuno-PET scans with a non-therapeutic tracer dose (2 mg) of 89Zr-pembrolizumab; one with and one without a preceding cold therapeutic dose of pembrolizumab."
15976170|NCT03065751|Device|Plasmaexchange|TPE against fresh frozen plasma
15976171|NCT03065738|Other|tibial reduction osteotomy in total knee replacement|reduction osteotomy :downsizing of tibial tray with lateralization
15976172|NCT03065725|Procedure|late FDG|In addition to regular FDG-PET/CT 60 minutes post injection, an extra scan 180 minutes post injection is made.
15976173|NCT03065712|Drug|F-18 Fluoroestradiol|F-18 Fluoroestradiol will be administered for PET/CT scan.
15976174|NCT03065712|Procedure|Computed Tomography|Undergo PET/CT
15976175|NCT03065712|Procedure|Positron Emission Tomography|Undergo PET/CT
15976176|NCT03065712|Other|Laboratory Biomarker Analysis|Correlative studies
15976177|NCT03065699|Device|DIALIVE Liver Dialysis Device|ACLF patients will receive dialysis treatment for 8-12 hrs/day and on three to five consecutive days over a 10-day time period. Dialysis treatment is performed by using the DIALIVE device provided by YAQRIT Ltd.
15976178|NCT03065686|Genetic|identification of genetic factors|Clinical questionnaire and analysis of genetic data obtained by exome high-throughput sequencing
15976179|NCT03065673|Procedure|Potassium oxalate 5% gel|"Teeth will be cleaned using rubber cups associated to pumice and water
~Relative isolation with roller cotton will be done;
~Prior to each bleaching session, the patients will receive the potassium OXALATE 5%
~Gingival dam will be performed using a fluid resin (Top Dam, FGM, Brazil) desensitivity gel application on vestibular surface, for 10 minutes.
~A 35% hydrogen peroxide based bleaching agent will be mixed and applied on the vestibular surface of teeth, remaining for 40 minutes."
15976180|NCT03065673|Procedure|Placebo gel|"Teeth will be cleaned using rubber cups associated to pumice and water
~Relative isolation with roller cotton will be done;
~Prior to each bleaching session, the patients will receive the placebo gel
~Gingival dam will be performed using a fluid resin (Top Dam, FGM, Brazil) desensitivity gel application on vestibular surface, for 10 minutes.
~A 35% hydrogen peroxide based bleaching agent will be mixed and applied on the vestibular surface of teeth, remaining for 40 minutes."
15976181|NCT03065660|Drug|Mifepristone, Oral, 200 Mg|The Investigational Medicinal Product (IMP) is a single dose of 200mg mifepristone to be taken orally after confirmation of missed miscarriage by pelvic ultrasound scan.
15976182|NCT03065660|Drug|Placebo Oral Tablet|The placebo will be an oral tablet in the same form as the IMP, and identical in appearance.
15976183|NCT03065647|Device|Expedited Transport With Mechanical CPR|Patients with OHCA refractory to initial BLS and ACLS will be transported by EMS with ongoing mechanical CPR and ACLS to an emergency department capable of initiating ECPR.
15976184|NCT03065634|Behavioral|Return to work and living healthy after head and neck cancer|Return to work and living healthy after head and neck cancer (RELIANCE) is a 2-months group intervention for head and neck cancer patients delivered by a trained psychotherapist and a peer in eight sessions. The individual sessions aim to improve work ability, quality of life and psychological well-being
15976185|NCT03065634|Behavioral|socio-legal counseling|"Non-manualized socio-legal counseling
~two socio-legal counseling sessions delivered by a social worker"
15976186|NCT03065621|Drug|Palbociclib|Each cycle will be 28 days. Patient will take study drug daily during 21 days and then have a rest period of 7 days.
15976187|NCT03065595|Dietary Supplement|Ophiochepalus striatus extract|each sachet of ophiochepalus striatus extract is poured into 50 mL normal water and drink two times/day
15976188|NCT03065595|Other|Placebo|each sachet of placebo drug is poured into 50 mL normal water and drink two times/day
15976191|NCT03065582|Other|Topical Product C|Topical application of antioxidants only
15976192|NCT03065582|Other|Control|No product applied
15976193|NCT03065569|Drug|Bupivacaine|16 mL of 0.125% bupivacaine
15976194|NCT03065556|Drug|188-0551 Solution|Topical solution containing active drug
15976195|NCT03065556|Drug|Vehicle Solution|Topical solution containing no active drug
15976196|NCT03065530|Drug|Normal Saline|Drug: Normal saline control group receive NS after delivery. Drug: butorphanol tartrate PCA: butorphanol tartrate after cesarean section.
15976197|NCT03065530|Drug|Dexmedetomidine 0.03ug/kg/h|Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.03ug/kg/h Dexmedetomidine after cesarean section.
15976198|NCT03065530|Drug|Dexmedetomidine 0.05ug/kg/h|Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.05ug/kg/h Dexmedetomidine after cesarean section.
15976199|NCT03065530|Drug|Dexmedetomidine 0.08ug/kg/h|Drug: Dexmedetomidine This group receive Dex 0.5ug/kg after delivery. Drug: butorphanol tartrate and Dexmedetomidine. PCA: butorphanol tartrate with 0.08ug/kg/h Dexmedetomidine after cesarean section.
15976200|NCT03065517|Device|VillageWhere App|VillageWhere is a mobile phone app for use on both Android and iOS platforms by youth with conduct disorders and their parents.
15976201|NCT03065517|Device|Attention-Control Placebo App|Mobile phone app for use on both Android and iOS platforms.
15976202|NCT03065504|Dietary Supplement|Turmeric|
15976203|NCT03065504|Dietary Supplement|Turmeric-containing combination tablet|
15976204|NCT03065504|Dietary Supplement|Placebo tablets|
15976205|NCT03065491|Dietary Supplement|Combined nutraceutical|Plant sterols 800 mg + Red Yeast Rice containing 5 mg monacolin K + L-Tyrosol 50 mg per daily dose Oral administration: 1 tablet per day
15976206|NCT03065491|Other|Placebo|Oral administration: 1 tablet per day
15976207|NCT03065478|Dietary Supplement|OnLife|Daily dosing of dietary supplement OnLife
15976208|NCT03065465|Device|Over-the-scope hemoclipping device|A endoscopic entrapment of tissue for control of bleeding or other applications.
15976209|NCT03065465|Other|Standard endoscopic treatment|Standard therapy includes injection of dilute epinephrine, thermal coagulation with multipolar electrocautery (MPEC) probe, and/or hemoclips.
15976210|NCT03065439|Diagnostic Test|Static balance testing|Postural sway will be measured using a force plate (Metitur Good Balance System®).
15976211|NCT03065400|Drug|Pembrolizumab|200 mg of Pembolizumab administered via intravenous infusion over 30 mins given every 3 weeks
15976212|NCT03065387|Drug|Everolimus|Given PO
15976213|NCT03065387|Drug|Neratinib|Given PO
15976214|NCT03065387|Drug|Palbociclib|Given PO
15976215|NCT03065387|Drug|Trametinib|Given PO
15976216|NCT03065374|Biological|IMM-529|IMM-529
15976217|NCT03065374|Other|Placebo|Matching placebo
15976218|NCT03065348|Dietary Supplement|oral whey protein|This substance is specifically formulated to target the nutritional needs of the elderly when they require increased energy and strength, such as following a fall or fracture or for the management of under nutrition and frailty. It provides 300 kcal, 20g of protein and increased levels of vitamin D, calcium. Available in vanilla, caramel and strawberry-biscuit
15976219|NCT03065348|Dietary Supplement|Immunonutrition|This substance is a clinically proven nutritional solution for the dietary management of major elective surgery patients, to improve clinical outcomes, and reduce postoperative complications and length of hospital stay. IMPACT formulation contains omega-3 fatty acids, arginine and nucleotides, and is suitable for use as a sole source of nutrition. Oral IMPACT is a powdered sip feed that provides 303kcal per portion when reconstituted with water (74g powder plus 250ml water) and is enriched with omega-3 fatty acids, arginine, nucleotide, 3 gr of soluble fibre 321mg sodium, 402 mg potassium, 216 mg phosphate per portion.
15976220|NCT03065348|Dietary Supplement|Carbohydrate Drink|"Resource® preload™ contains the following elements:
~Per portion à 50gr 47.5 gr carbohydrate, < 10mg sodium, 190kcal"
15976221|NCT03065348|Other|Preoperative hydration|If urine specific gravity is >1.020 then additional tap water drinking will be encouraged (1% of ideal body weight)
15976222|NCT03065348|Other|continous spinal anesthesia|Surgery will be performed under continuous spinal anesthesia without general anesthesia
15976223|NCT03065335|Drug|Ketamine|N-methyl-D-aspartate (NMDA) glutamate receptor (NMDA-R) antagonist
15976224|NCT03065335|Other|Placebo|Placebo comparator
15976225|NCT03065322|Other|To assess risk of OSA|The risk of OSA will be assessed using the Berlin questionnaire and the Epworth Sleepiness Scale (ESS). Women with at high risk of OSA will have home-based sleep studies performed. Study participants will be divided based on the results of the Berlin and ESS questionnaires and sleep studies into two groups: 1) PCOS low risk OSA: women with normal ESS and normal Berlin questionnaire (no sleep studies performed), or women with normal sleep studies; and 2) PCOS OSA: women with OSA proven by sleep studies.
15976226|NCT03065309|Drug|Remifentanil|bolus dose
15976227|NCT03065296|Behavioral|Musculoskeletal (MSK) Prescription Didactic Lectures|In between phase 1 and phase 2 there will be a series of didactic lectures to educate resident on home exercise prescription and get them familiarized with the handouts.
15976228|NCT03065296|Other|Musculoskeletal (MSK) home exercise hand-outs|In between phase 1 and phase 2, residents will use home exercise hand-outs readily available and educate their patients in regards to those.
15976229|NCT03065283|Procedure|Diaphragm lift|The purpose is to generate the stretch of the peripheral fibers of the diaphragm, being performed with the patient in the supine position and the physiotherapist standing on the patient's head and Pulling the Your costal arch In the cephalic direction, for one minute, twice
15976230|NCT03065283|Procedure|Relaxation of the diaphragm pillars|Second technique aims to promote the rhythmic stretching of the double psoas diaphragm pillars, being performed with The patient in the ventral position and the therapist standing at his side placing the ulnar border of his cephalic hand on the last ribs and his caudal hand flattened in front of the popliteal fossa of the popliteal fossa, stretching was done for one minute
15976231|NCT03065270|Other|Use unstable shoes Masai Barefoot Technology (MBT)|Use of unstable shoes during 9 weeks, at least four hours per day.
15976232|NCT03065270|Other|Use conventional sport shoes|Use of conventional sport shoes during 9 weeks, at least four hours per day.
15976233|NCT03065257|Procedure|Endoscopic Resection|Any Endoscopic resection for Gastrointestinal disorders including neoplasms.
15976234|NCT03065244|Drug|IVIG|Subjects randomized to this arm will receive IVIG 2g/kg over 10-12 hours
15976235|NCT03065244|Drug|Infliximab|Subjects randomized to this arm will receive infliximab 10 mg/kg over 2 hours
15976236|NCT03065231|Device|Extraventricular Drain|As mentioned above, intervention will take place to promote subarachnoid blood diversion from cerebrospinal fluid after ruptured intracranial aneurysm.
15976237|NCT03065231|Device|Lumbar Drain|
15976238|NCT03065218|Radiation|99mTc sestamibi|The patient will receive an injection into the vein of a radioisotope 99mTc sestamibi dose 25mCi and will be imaged in 1 day.
15976239|NCT03065205|Device|Propeller Health device + asthma navigator|The patients will be monitored using the propeller health device for 6 months. The patients will be contacted at 2 month intervals by an asthma health educator to discuss barriers to adherence to asthma medications
15976240|NCT03065192|Drug|VY-AADC01|Single dose, neurosurgically infused, bilaterally into the striatum.
15976241|NCT03065179|Drug|Nivolumab/Ipilimumab|IV immunotherapy
15976242|NCT03065179|Radiation|SBRT|SBRT will be delivered in conjunction with immunotherapy
15976243|NCT03065166|Other|Raisin Treatment|Subjects will consume 3.2oz of dried Cabernet grapes during a single intervention time point.
15976244|NCT03065166|Other|Bagel Control|Subjects will consume 95g of whole wheat bagel during a single intervention time point.
15976245|NCT03065140|Other|Training or detraining|A period of detraining or a supervised exercise program.
15976246|NCT03065127|Behavioral|Cognitive Training|Training the cognitive domain may be accomplished by training various cognitive and executive functions with guided practice focusing on specific skills (e.g. visuospatial processing, executive function, memory, language, and attention). Cognitive training has been demonstrated to be efficacious in several studies in individuals with PD. Given the potential cognitive contribution to FOG episodes, this type of therapy may alleviate FOG by potentially improving upon planning, set-shifting, and/or response inhibition.
15976247|NCT03065127|Behavioral|Cognitive Behavioural Therapy|CBT has been demonstrated to be effective in the remediation of anxiety in individuals with PD. This may be beneficial to individuals experiencing FOG, given the evidence that anxiety may provoke FOG. During periods of elevated anxiety (e.g. walking in a threatening environment), freezers will be able to more efficiently process this limbic load resulting in greater resources available for movement control.
15976248|NCT03065127|Behavioral|Proprioceptive Training|Currently, studies investigating proprioceptive training as a treatment in PD are limited. However, this type of training has potential by improving proprioceptive processing. It would be expected that due to this training, when sensorimotor processing is challenged during locomotion (e.g. by removing visual feedback and preventing compensation of proprioception deficits), freezers would experience less decrements to gait due to an enhanced ability to process sensorimotor demands.
15976249|NCT03065114|Other|PGS|chromosome abnormality test from PGS and relationship between embryo development
15976250|NCT03065101|Device|Trigen Intertan|While both the Trigen InterTAN and Sliding Hip Screw are marketed and demonstrated to be suitable for treatment of the study indication, the randomisation is considered an intervention as it may be contrary to the treatment chosen by the surgeon were the patient not a study subject.
15976251|NCT03065101|Other|Post-Surgery Follow Up|The current clinical trend is for minimal follow up post-surgery, unless indicated by complications. The study protocol indicated that follow up telephone visits are to be performed at 8 weeks, 12 weeks and 12 months post-surgery and an outpatient follow up visit at 6 months post-surgery. While most outcome measures are conducted via questionnaire, the increase in follow up means that subjects may be exposed to increased ionising radiation.
15976252|NCT03065101|Device|Sliding Hip Screw|Sliding Hip Screw
15976253|NCT03065088|Behavioral|aLIFE|The aLiFE programme is taught by an instructor during six home visits and 3 phone calls during the 6-month intervention period. The programme will be personalised by use of an initial balance and strength assessment (aLiFE assessment tool). The participants assigns activities to his or her daily activities, and during subsequent home visits, the number of activities and task demands are upgraded. Participants will be taught how to select opportunities themselves to embed activities into their individual daily routine, and how to progress over time.
15976254|NCT03065088|Behavioral|eLIFE|The eLIFE includes a personalised ICT-administered training schedule using the activities developed in aLiFE, delivered in the form of video clips, pictures and text/verbal instructions on a smartphone and smartwatch application. Personalisation of activity content will be decided based on a phenotype tool and initial difficulty level is decided through the aLiFE assessment tool. In addition, a virtual instructor teaches the participants how to carry out the eLiFE programme. The user receives motivational messages and feedback, and there will be a possibility for social interaction between the participants. The instructors teach the eLiFE participants the programme during 4 home visits and 3 phone calls during the 6 month intervention period.
15976255|NCT03065088|Behavioral|control|The control group follows the World Health Organization's recommendations of physical activity. The control participants will receive one home visit and be given a written letter with the activity recommendations.
15976256|NCT03065075|Drug|Phenazopyridine|Phenazopyridine 200 mg on morning of postoperative day 1
15976257|NCT03065062|Drug|Palbociclib|Palbociclib will be administered orally once daily, 3 weeks out of every 4 in each cycle. The initial dose for part 1 of the study will be 100 mg daily. Dosing will be adjusted until Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) are established. No pre-medications for palbociclib are required. It should be administered with food.
15976258|NCT03065062|Drug|Gedatolisib|Gedatolisib will be administered once weekly on the first day for each of the four weeks during the 4-week cycle. The initial dose for part 1 of the study will be 110 mg. Dosing will be adjusted until Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) are established. No pre-medications for gedatolisib are required.
15976259|NCT03065049|Behavioral|Peer-Facilitated Counseling|Participants will engage in a 12-week physical activity intervention guided by a peer-facilitator at the methadone clinic they receive treatment. Participants will attend weekly groups, engage in a guided walking group, and utilize the Fitbit to self-monitor physical activity.
15976260|NCT03065049|Behavioral|Fitbit activity tracker|Participants will be given a Fitbit activity tracker to monitor physical activity.
15976261|NCT03065036|Drug|prestudy topical glaucoma medications|Reintroduction of prestudy topical glaucoma medications, introduced one medication at a time during each study visit, as necessary.
15976262|NCT03065023|Drug|MK-4621|IT/IL injection Fixed concentration of 0.2 mg/mL Starting dose: 0.2 mg
15976263|NCT03065010|Drug|BCD-115|Inhibitor of CDK8/19
15976264|NCT03064997|Dietary Supplement|Synergy 1|a daily dose: 7 g/day of Synergy1 (oligofructose enriched inulin) consumed for 12 weeks together with a strict gluten-free diet
15976265|NCT03064997|Dietary Supplement|Placebo|a daily dose: 7 g/day of placebo (maltodextrin) consumed for 12 weeks together with a strict gluten-free diet
15976266|NCT03064984|Other|CBS eyedrops|CBS eyedrops (prepared from umbilical cord blood serum) will be provided as frozen vials containing 0.8 ml of the product and will be administered at a regimen of 1 drop / 8 times day / each eye during the waking period, with the last administration to take before bedtime.
15976267|NCT03064984|Other|PBS eyedrops|PBS eyedrops (prepared from adult peripheral blood serum) will be provided as frozen vials containing 0.8 ml of the product and will be administered at a regimen of 1 drop / 8 times day / each eye during the waking period, with the last administration to take before bedtime.
15976268|NCT03064971|Behavioral|Standard Care|Standard of care provided by QuitlineNC includes Quit Coaches, counseling calls, nicotine replacement therapy, and written materials
15976269|NCT03064971|Behavioral|smoking cessation DVD|"The evidence-based How to Quit DVD contains 60 minutes of smoking cessation information and strategies"
15976270|NCT03064971|Behavioral|PTF DVD|Culturally specific smoking cessation DVD. This DVD contains 60 minutes of material.
15976271|NCT03064958|Other|Herbs and spices|Mix of commonly used herbs and spices
15976272|NCT03064958|Other|High fat meal|Meal containing 1000kcal and 45g fat
15976273|NCT03064945|Device|Livia|Livia® Transcutaneous Electrical Nerve Stimulation (TENS) is a novel pain management device for women suffering from dysmenorrhea
15976274|NCT03064932|Other|Controlled feeding diet|Average American diet with different levels of spices
15976275|NCT03064919|Behavioral|Curriculum Testing|An evidence-based curriculum for teaching preschool children to eat in response to internal hunger and fullness signals was developed by refining an existing curriculum. State-of-the art theories in early childhood science education, innovative virtual technology to provide more realistic simulations of hunger and fullness, and a parent training component to improve long-range sustainability were incorporated. This 9-wk intervention will be tested by forty children (ages 4-5). Key outcomes will be children's adjustment in intake in response to a first course (energy compensation) and children's intake of tasty snacks when not hungry (eating in the absence of hunger). Additionally, the investigators will measure other variables likely to impact the success of the curriculum, for example: child gender/age, parent feeding practices, parent education, infant feeding practices, child/parent weight status, and others.
15976276|NCT03064906|Device|Insulet AP (artificial pancreas) System|Insulet AP (artificial pancreas) system, using the Omnipod® insulin management system, Dexcom G4 Share® AP System and personalized model predictive control algorithm.
15976277|NCT03064893|Device|Alloderm|Reconstruction material
15976278|NCT03064893|Device|Dermacell|Reconstruction material
15976279|NCT03064880|Other|SV maximization|Voluven solution 250 mL infusion per 5 minutes up to the platau of Flank-starling law: status to SV change < 10% and maintained for 20 minutes
15976280|NCT03064867|Drug|Venetoclax|"Beginning with 400mg daily on days 1-10 of cycle 1-3
~Phase I dose escalation scheme:
~Dose Level -2 (DL-2): 100 mg daily, days 1-10, cycle 1-3
~DL-1: 200 mg daily, days 1-10, cycle 1-3
~DL1: 400 mg daily, days 1-10, cycle 1-3
~DL2: 600 mg daily, days 1-10, cycle 1-3
~DL3: 800 mg daily, days 1-10, cycle 1-3
~Phase II: Given at a dose of 400mg daily for 5 days"
15976281|NCT03064867|Drug|Rituximab|"Part of R-ICE treatment:
~Rituximab: 375 mg/m^2 intravenously (IV) on Day 1 of R-ICE every 21 days"
15976282|NCT03064867|Drug|Ifosfamide|"Part of R-ICE treatment:
~Ifosfamide: 5,000 mg/m^2 mixed together with mesna at a dose of 5,000 mg/m^2 over 24 hours beginning on Day 2 and completing on Day 3 of each 21-day cycle"
15976283|NCT03064867|Drug|Carboplatin|"Part of R-ICE treatment:
~Carboplatin: At a dose corresponding to an AUC = 5 based on Cockcroft-Gault calculation of GFR using adjusted body weight. Carboplatin is given IV on the Day 2 of RICE of each 21 day cycle"
15976284|NCT03064867|Drug|Etoposide|"Part of R-ICE treatment:
~Etoposide: 100 mg/m2by IV daily on 3 consecutive days (Days 1-3) of each 21-day cycle"
15976285|NCT03064854|Drug|PDR001|Powder for solution for infusion
15976286|NCT03064854|Drug|Cisplatin|Intravenous infusion
15976287|NCT03064854|Drug|Gemcitabine|Intravenous infusion
15976288|NCT03064854|Drug|Pemetrexed|Intravenous infusion
15976289|NCT03064854|Drug|Carboplatin|Intravenous infusion
15976290|NCT03064854|Drug|Paclitaxel|Intravenous infusion
15976291|NCT03064854|Drug|Canakinumab|Subcutaneous injection
15976292|NCT03064841|Drug|No Treatment|No treatment
15976293|NCT03064828|Radiation|CT colonoscopy(normal dose)|Perform CT colonoscopy with full bowel preparation and inflated colon,CT Scans on subjects with normal-dose protocol by setting scanning parameters as 120-140 kVp, 100-200mA
15976294|NCT03064828|Radiation|CT colonoscopy (low dose)|Perform CT colonoscopy with full bowel preparation and inflated colon,CT Scans on subjects with normal-dose protocol by setting scanning parameters as 120-140 kVp, 20-100mA
15976295|NCT03064815|Device|Videocapsule endoscopy|"Capsule endoscopy is a procedure that uses a tiny wireless camera to take pictures of your digestive tract. A capsule endoscopy camera sits inside a vitamin-size capsule you swallow. As the capsule travels through your digestive tract, the camera takes thousands of pictures that are transmitted to a recorder you wear on a belt around your waist.
~Capsule endoscopy helps doctors see inside your small intestine - an area that isn't easily reached with more-traditional endoscopy procedures."
15976296|NCT03064815|Procedure|colonoscopy|Colonoscopy is a test that allows your doctor to look at the inner lining of your large intestine (rectum and colon). He or she uses a thin, flexible tube called a colonoscope to look at the colon.
15976297|NCT03064815|Diagnostic Test|PROMETHEUS® IBD sgi Diagnostic™|This test combines serologic, genetic, and inflammation markers in a proprietary Smart Diagnostic Algorithm to provide added IBD diagnostic clarity. This test helps physicians differentiate IBD vs. non-IBD and CD vs. UC in one comprehensive blood test.
15976298|NCT03064815|Diagnostic Test|Fecal calprotectin|A stool test to measure inflammation in the gut.
15976299|NCT03064802|Device|BioBurst Fluid, Burst Allograft|BioBurst Fluid or Burst Allograft used to augment spinal fusion
15976300|NCT03064776|Device|m-RESIST Patients|A mobile system based on Information and Communications Technology (ICT), which is addressed to empower patients suffering from TRS and to involve their caregivers
15976301|NCT03064776|Device|m-RESIST Caregivers|A mobile system based on Information and Communications Technology (ICT), which is addressed to empower patients suffering from TRS and to involve their caregivers
15976302|NCT03064763|Drug|Talimogene laherparepvec|Talimogene laherparepvec will be administered as an intralesional injection.
15976303|NCT03064750|Behavioral|pelvic floor exercises|In preparation for surgery, patients receive individual information by a physiotherapist on pelvic floor anatomy and correct pelvic floor contraction. Patients are told to do the following pelvic floor exercises 3 times a day: 8-12 maximal contractions, hold contractions during 10 seconds, and 3 fast contractions after each long contraction. In addition exercise in groups with skilled physical therapists once a week during 12 weeks.
15976304|NCT03064750|Other|Waiting list|patients wait as usual until surgery without special treatment.
15976305|NCT03064737|Other|Skin biopsy for genetic analyze|"It will be offered to a subgroup of adult patients carrying genetic markers predisposing to the severity of the LD infection, a skin biopsy in order to realize genetic analyses.
~This visit will be conducted once the results of genetic markers obtained (between 30 and 36 months), a specific consent will be required to patients.
~The skin biopsy will be performed according to the Clinical Department use."
15976306|NCT03064724|Behavioral|"Interactive Mobile Doctor (iMD)"|"iMD delivers tailored interactive video education via a mobile tablet to smoking patients right before their clinic visit with a provider. iMD delivers the 5 A's (ask, advise, assess, assist, and arrange) and generates a bilingual tailored printout, which aims to increase patient-provider discussion on tobacco use and to promote smoking cessation. This version of iMD delivers the intervention in Korean or Vietnamese languages as preferred by the patient."
15976307|NCT03064711|Diagnostic Test|Electronyugraphy|Surface electromyography (sEMG) recorded diaphragmatic muscle activity during rest and while performing maximal voluntary ventilation
15976308|NCT03064698|Other|Post-partum Doppler ultrasound|Participants will undergo one uterine artery Doppler ultrasound at 6 weeks post-partum.
15976309|NCT03064672|Device|transcervical Balloon Catheters|induction of labor by transcervical Balloon Catheters insertion
15976310|NCT03064646|Other|Organ Preservation|Patients with a complete response or a almost complete response after neoadjuvant treatment will be offered an organ preservation strategy
15976311|NCT03064633|Drug|dexamethasone 8 mg|At the level of the umbilicus, the high-frequency ultrasound linear array probe (L 4 - 12) will be placed transversely on the anterolateral abdominal wall between the subcostal margin and the iliac crest. localization of the fascial plane between the internal oblique and the transversus abdominis muscles will be done. The local anesthetic solution mixture will be injected with short bevel needle. The TAP block will be performed on the both side using the same technique and the same local anesthetic solution mixture volume. For the patients randomized to dexamethasone group, the local anesthetic solution mixture will consist of a total volume of 40 ml containing bupivacaine 0.25 % and dexamethasone 8 mg.
15976312|NCT03064633|Drug|dexmedetomidine 80 µg|At the level of the umbilicus, the high-frequency ultrasound linear array probe (L 4 - 12) will be placed transversely on the anterolateral abdominal wall between the subcostal margin and the iliac crest. localization of the fascial plane between the internal oblique and the transversus abdominis muscles will be done. The local anesthetic solution mixture will be injected with short bevel needle. The TAP block will be performed on the both sides using the same technique and the same local anesthetic solution mixture volume. For the patients randomized to dexmedetomidine group, the local anesthetic solution mixture will consist of a total volume of 40 ml containing bupivacaine 0.25 % and dexmedetomidine 80 µg.
15976313|NCT03064633|Drug|Bupivacaine 0.25% Injectable Solution|38 ml of the solution will be prepared to be used in transversus abdominis plane block
15976314|NCT03064620|Biological|PCV|PCV7 was introduced in Israel (IL and EJ) in July 2009 PCV13 replaced PCV7 in IL and EJ on Oct 2010 PCV10 was introduced in PA in 2011
15976315|NCT03064607|Other|Fluid collection|Fluids tested for biomarker S100beta
15976316|NCT03064594|Procedure|Cornual pregnancy|we will get the information of operative time, blood loss and postoperative pregnancy and delivery rate.
15976317|NCT03064581|Behavioral|Intervention|The educational session consisted of a one-hour small group discussion (5-10 people). Gender-specific community health educators facilitated sessions for Pacific Islander women and for their spouses/significant others that included an educational video and other materials (brochure, calendar, and resource list). The video emphasized the importance of Pap testing for Pacific Islander women, and showed men supporting their women to get tested. Women's sessions provided basic information on cervical cancer and pap testing, and ended with verbal commitments and target screening dates by women to get screened. The men's education sessions contained similar information, with supplemental information on how to provide support for their wives to get tested and exercises on showing their support.
15976318|NCT03064568|Drug|Misoprostol 100Mcg Tab|
15976319|NCT03064568|Drug|Placebo|
15976320|NCT03064542|Drug|carbimazole (CMZ) or thiamazole (TMZ)|CMZ or TMZ will be used to treat the hyperthyroidism till the FT4/TSH is in normal range.
15976321|NCT03064529|Device|Accelerometer|All participants receive a wrist worn accelerometer to measure physical activity continuously before and after surgery
15976322|NCT03064516|Procedure|Endocrown|In experimental group, the researches will be performed in the Endocrown group- only the ceramic restoration will fill the pulp chambre in teeth treated endodontically. Cusps will be preserved.
15976323|NCT03064516|Procedure|Onlay and fiber pin|In control group, the researches will be performed in the onlay ceramic restorations with glass fiber pin group in endodontically treated teeth- the teeth receive a fiberglass pin in the main root canal and composite resin filling. Cusps will be preserved.
15976324|NCT03064503|Biological|Blood sampling|Blood sampling will be performed at inclusion to investigate some biological eligibility criteria, and the day of MRI in order to analyse fibrosis biomarkers and collagen synthesis biomarkers
15976325|NCT03064503|Device|MRI|MRI will be performed to measure interstitial fibrosis
15976326|NCT03064503|Biological|Skin auto-fluorescence|Skin auto-fluorescence measures will be performed to measure advanced glycation end-products (AGE) produced by collagen degradation
15976328|NCT03064477|Behavioral|Unified Protocol|Intervention group that carries out the Unified Protocol in a group format
15976329|NCT03064477|Behavioral|Cognitive Behavioral Therapy (TAU)|TAU group that carries out Cognitive Behavioral Therapy in an individual format
15976330|NCT03064464|Other|None Intervention|It is observational study, no interventios to any of the three study arms
15976331|NCT03064451|Procedure|cartofinder guided ablation followed by PVI|cartofinder guided ablation followed by PVI
15976332|NCT03064438|Drug|ACCU-D1|ACCU-D1
15976333|NCT03064438|Drug|Vehicle|Placebo Comparator
15976334|NCT03064425|Biological|Vaginal and blood sample collection|The researchers will obtain approximately 20 mL of blood from participants. Participants will also undergo a pelvic exam where a sample of cells will be collected from the cervix using two small cytobrushes. In addition, a cervicovaginal lavage will be collected using saline.
15976335|NCT03064412|Biological|Urine sample collection|A urine sample will be collected in each of the 3 trimesters of pregnancy, and also at 6 weeks post partum.
15976336|NCT03064412|Biological|Saliva collection|A saliva sample will be collected at one time point during the study - likely at the initial baseline visit.
15976337|NCT03064399|Procedure|without lateral ligament repairment|microfracture without repairment of the lateral ligament
15976338|NCT03064399|Procedure|lateral ligament repairment|microfracture combined with repairment of the lateral ligament
15976339|NCT03064386|Procedure|Plate fixation|internal fixation with the plate
15976340|NCT03064386|Procedure|Screw fixation|internal fixation with the screw
15976341|NCT03064360|Other|Laboratory Biomarker Analysis|Blood drawn for biomarker analysis at baseline and study exit. Finger sticks at baseline, interim, and study exit.
15976342|NCT03064360|Device|Patient Activity|Continuous monitoring of Patient Reported Informatics (PRIs) at study entry to study completion.
15976343|NCT03064360|Behavioral|Questionnaires|Symptom and quality of life questionnaire at baseline, and every week following to study completion
15976344|NCT03064347|Dietary Supplement|Sucrose plus Whole Milk Powder in Enteric Coating|Single dose enteric coated sucrose plus whole milk powder will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
15976345|NCT03064347|Dietary Supplement|Non coated Sucrose plus Whole Milk|Single dose sucrose plus whole milk powder with separate enteric coating materials will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
15976346|NCT03064347|Dietary Supplement|Sucrose in Enteric Coating|Single dose enteric coated sucrose will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
15976347|NCT03064347|Dietary Supplement|Sucrose with Separate Enteric Coating Materials|Single dose sucrose with separate enteric coating materials will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
15976348|NCT03064347|Dietary Supplement|Whey Protein in Enteric Coating|Single dose enteric coated whey protein will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
15976349|NCT03064347|Dietary Supplement|Whey Protein with Separate Enteric Coating Materials|Single dose whey protein with separate enteric coating materials will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
15976350|NCT03064347|Dietary Supplement|Pea Protein in Enteric Coating|Single dose enteric coated pea protein will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
15976351|NCT03064347|Dietary Supplement|Pea Protein with Separate Enteric Coating Materials|Single dose pea protein with separate enteric coating materials will be consumed by mouth. Blood will be drawn at baseline and then at 15 minute intervals for 3 hours from ingestion for measurement of GLP-1, PYY, C-peptide, insulin and glucose.Visual analog score will be used to record satiety and adverse symptoms every 15 minutes.
15976352|NCT03064334|Procedure|Total Knee Arthroplasty|surgical knee joints Arthroplasty
15976353|NCT03064321|Behavioral|Insomnia Intervention|The SHUTi intervention is based on a cognitive behavioral treatment for insomnia (CBT-I) and organized into six structured, weekly online sessions. Each week the participants will complete a 30-minute interactive learning module and to complete daily online sleep diaries will be used.
15976354|NCT03064321|Other|Information Control|Information on websites that are general health promoting
15976355|NCT03064308|Other|Exercise Programme|Participants will complete the High-Intensity Functional Exercise (HIFE) programme. The programme improves lower-limb strength, balance and mobility and all the exercises can be performed by the individual at home and with minimal equipment.
15976356|NCT03064295|Device|Myocardial Perfusion Cardiac MRI.|MRI with administration of a contrast drug and a stress agent, if no contraindications are present. The gadolinium based contrast agent to be used in this study is either Gadavist (up to 0.2 mL/kg body weight (0.2 mmol/kg) or MultiHance (0.2 mmol/kg) The IV stress agent is regadenoson (0.4mg/5ml bolus) or adenosine (dosage based on subject's weight and is set at 140mcg/kg/min
15976357|NCT03064295|Drug|Contrast|The intravenous gadolinium based contrast agent to be used in this study is either Gadavist (up to 0.2 mL/kg body weight (0.2 mmol/kg) or MultiHance (0.2 mmol/kg)
15976546|NCT03063021|Drug|N-Acetyl Cysteine (NAC)|Oral tablets of N-acetyl-cysteine
15976358|NCT03064295|Drug|Pharmacologic Stress Agent|The stress agent administered intravenously is regadenoson (0.4mg/5ml bolus) or adenosine (dosage based on subject's weight and is set at 140mcg/kg/min
15976359|NCT03064282|Other|Placebo|observation of skin changes if any
15976360|NCT03064282|Drug|papaverine|observation of symptoms
15976361|NCT03064269|Biological|CD19 CAR-T cells|CNS leukemia is defined as unequivocal evidence of leukemic blasts in the cerebrospinal fluid by cytology or flow cytometry; cranial palsies or a nonhemorrhagic mass seen in cranial computed tomography or magnetic resonance imaging because of infiltration by leukemia cells
15976362|NCT03064256|Behavioral|Physical training program|Physical training program consisted of three weekly sessions lasting up to one hour over a period of twelve weeks. and will be carried out respecting the traditional training principles: biological individuality, Specificity, overload, adaptation and reversibility
15976363|NCT03064256|Behavioral|Physical training program|All sessions were started with stretches for lower and upper limbs lasting 10 minutes for warm-up, and after trekking on treadmill using the predetermined critical velocity (Vcrit). The exercises were completed with cooling of the muscle groups for one minute still on the treadmill, plus 10 minutes of relaxation exercises on the mat at the end of aerobic exercise.
15976364|NCT03064243|Drug|apatinib|apatinib 500mg po. qd.
15976365|NCT03064230|Other|QoL questionnaire SF-12 and and a screening questionnaire|patient were asked to fill questionnaires
15976366|NCT03064217|Procedure|CLP and 12 weeks waiting|Restorative treatments will be initiated 12 weeks after clinical crown lengthenings (CLPs).
15976367|NCT03064217|Procedure|Digital impression taken at surgery|The final impression will be made at surgery.
15976368|NCT03064191|Combination Product|calcium hydroxide chlorhexidine combination|Endodontic intra-canal medicament used for decreasing postoperative signs ans symptoms
15976369|NCT03064191|Other|calcium hydroxide intra-canal medicament|Endodontic intra-canal medicament used for decreasing postoperative signs and symptoms.
15976370|NCT03064165|Drug|Bupivacaine-epinephrine|Nerve block with 15 mL bupivacain 5 mg/mL with epinephrine 5 µg/mL.
15976371|NCT03064165|Procedure|Sham block|Injection as for obturator nerve block, but with placebo
15976372|NCT03064165|Procedure|Obturator nerve block|Postoperative obturator nerve block
15976373|NCT03064165|Drug|Sodium Chloride 9mg/mL|Placebo
15976374|NCT03064152|Device|Rotational Thromboelastometry|ROTEM is a point-of-care coagulation assay.
15976375|NCT03064139|Behavioral|MCG|Community-based in person group training n mindful walking over 11 sessions in 6-months+ Activity monitor with feedback on activity levels
15976376|NCT03064139|Behavioral|SCG|Community-based in person group education in management of knee osteoarthritis (importance of physical activity, weight management, etc.) over 11 sessions in 6 months + Activity monitor with feedback on activity levels
15976380|NCT03064113|Drug|Placebo|
15976381|NCT03064113|Drug|TD-4208 700 μg|
15976382|NCT03064113|Drug|TD-4208 350 μg|
15976383|NCT03064113|Drug|Ipratropium 500 μg|
15976384|NCT03064100|Other|Observational Study|Exclusion from the study
15976385|NCT03064087|Device|Colli-Pee|First, two first-void urine samples will be collected with the Colli-Pee device (Novosanis NV, Wijnegem, Belgium) at home, the day before a visit to the colposcopy centre at a gynecology clinic.
15976386|NCT03064087|Device|Multi-Collect Swab|At the colposcopy clinic, one vaginal self-sample will be collected with the Multi-Collect Swab (Abbott GmbH & Co. KG, Wiesbaden, Germany).
15976387|NCT03064087|Device|Evalyn Brush|Another vaginal self-sample will be collected also at the colposcopy centre either with the Evalyn Brush (Rovers Medical Devices B.V., Oss, Netherlands)
15976388|NCT03064087|Device|Qvintip|or with Qvintip (Aprovix AB, Uppsala, Sweden).
15976389|NCT03064087|Diagnostic Test|Abbott RealTime High Risk HPV|The hrHPV assay used, will be the Abbott PCR (Abbott GmbH & Co. KG, Wiesbaden, Germany), which detects separately DNA of HPV16 and HPV18, as well as the pool of twelve other hrHPV types (HPV 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). The accuracy of this PCR assay for the detection of CIN2+ will be determined on all samples: on the first urine sample and on the vaginal and cervical samples. Furthermore, it is possible that in the future other assays will be validated.
15976390|NCT03064074|Drug|Fresolimumab|The purpose of this study is to determine if fresolimumab is safe as a treatment for OI. We will evaluate the safety of a single dose of fresolimumab in the 1st stage of the study. We will evaluate the safety of multiple doses of fresolimumab in the 2nd stage of the study. The Investigators will evaluate the effect of the two doses of fresolimumab in Stage 1 on markers of bone turnover and determine the dose that shows the greatest reduction in bone turnover markers compared to no treatment. This dose will be chosen for the repeat dose studies. If there were no significant changes between the bone turnover markers with either dose, the 4 mg/kg dose will be chosen for the repeat dose study.
15976391|NCT03064061|Device|Virtual reality|a device with virtual reality is given to the patients with a film of 18 minutes
15976392|NCT03064048|Dietary Supplement|Neo-ASA|Dietary supplement with nitric oxide in the form of a lozenge called Neo-ASA.
15976393|NCT03064048|Dietary Supplement|Placebo|Dietary supplement with no nitric oxide in the form of a lozenge to look and taste like the dietary supplement Neo-ASA
15976437|NCT03063749|Device|Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System|Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 2.0 mm - 4.0 mm
15976707|NCT03061656|Drug|Melphalan|2nd HDCT
15976394|NCT03064035|Drug|4-factor prothrombin complex concentrate (4FPCC)|4-factor prothrombin complex concentrate (4FPCC) contains all of the vitamin K-dependent clotting factors inhibited by warfarin, making it desirable for use in warfarin reversal for emergent bleeds. Multiple guidelines currently recommend 4FPCC for warfarin reversal in vitamin K-dependent major bleeding or intracranial hemorrhage. 4FPCC has a fast onset of action and has demonstrated significant reversal of INR within 10 minutes. Its duration of action is up to 8 hours, and for this reason it should be given concurrently with vitamin K. Vitamin K has a delayed onset of action due to its need to stimulate the synthesis of clotting factors so its effects begin as the effects of 4FPCC diminish. 4FPCC is the standard of care treatment for this clinical population in the Regions Hospital Emergency Department.
15976395|NCT03064022|Other|Growth|Some preterm infants grow at higher rates than others
15976396|NCT03064009|Other|Infection|This is an observational trial
15976397|NCT03063996|Procedure|peripheral IV access procedure|standard of care guided IV access into peripheral vein excluding IJ
15976398|NCT03063996|Procedure|Peripheral IJ access procedure|standard of care guided IV access into IJ
15976399|NCT03063983|Drug|Cyclophosphamide|Continuous oral cyclophosphamide
15976400|NCT03063983|Drug|Methotrexate|Continuous oral methotrexate
15976401|NCT03063970|Device|Dynamic Lycra Orthosis|Dynamic lycra orthoses: made to measure fabric lycra compression gauntlets individually tailored to correct upper limb movement and positioning. Worn for eight hours per day but may be removed for therapy and washing.
15976402|NCT03063970|Other|Usual Rehabilitation|Physiotherapy or Occupational Therapy delivered as routine part of rehabilitation
15976403|NCT03063944|Drug|STAT Inhibitor OPB-111077|Given PO
15976404|NCT03063944|Drug|Decitabine|Given IV
15976405|NCT03063944|Drug|Venetoclax|Given PO
15976406|NCT03063944|Other|Laboratory Biomarker Analysis|Correlative studies
15976407|NCT03063931|Drug|Magnesium: Magnésium UPSA Action Continue®|This clinical trial compares magnesium and placebo for the prevention of neuropathic pain induced by mastectomy assessed with a (0-10) numerical pain rating scale
15976408|NCT03063931|Drug|Placebo: Lactose|This clinical trial compares magnesium and placebo for the prevention of neuropathic pain induced by mastectomy assessed with a (0-10) numerical pain rating scale
15976409|NCT03063918|Other|Informational Intervention|Receive a workbook
15976410|NCT03063918|Other|Quality-of-Life Assessment|Ancillary studies
15976411|NCT03063918|Other|Questionnaire Administration|Ancillary studies
15976412|NCT03063918|Other|Survey Administration|Ancillary studies
15976413|NCT03063918|Behavioral|Telephone-Based Intervention|Receive personalized dietary intervention
15976414|NCT03063905|Drug|Buprenorphine|Patients taking buprenorphine to wean off an opiate addiction
15976415|NCT03063892|Drug|Tranexamic Acid (TXA)|Tranexamic acid is an antifibrinolytic used to control bleeding
15976416|NCT03063892|Drug|Saline solution|Saline solution is used as the placebo comparator
15976417|NCT03063879|Drug|Sofosbuvir 400 mg and daclatasvir 60 mg|Daily fixed dose combination pill (Sovodak) containing 400 mg sofosbuvir and 60 mg daclatasvir for 12 weeks if not cirrhotic (liver stiffness < 12 KPa) or 24 weeks if cirrhotic
15976418|NCT03063866|Drug|Propofol|Propofol 1 mg/kg i.v
15976419|NCT03063866|Drug|Midazolam|Midazolam 3 mg i.v
15976420|NCT03063866|Drug|Fentanyl|fentanyl 0.5 ug/kg
15976421|NCT03063853|Other|Removal of surgical clips at day 4 post operative vs day 8 post operative|Removal of surgical clips at day 4 post operative vs day 8 post operative
15976422|NCT03063853|Procedure|Elective cesarean delivery|non emergent elective cesarean delivery
15976423|NCT03063840|Device|Microwave ablation|Microwave ablation (MWA): Emprint Microwave Ablation system with 2.45 GHz microwave generator
15976424|NCT03063827|Drug|OnabotulinumtoxinA 200 UNT|Patient in the treatment arm received a single injection of onabotulinumtoxinA 200 UNT to the detrusor muscle at 20 sites of the bladder body.
15976425|NCT03063827|Diagnostic Test|Urothelial sensory protein levels|Bladder tissues were investigated for urothelial barrier and inflammation proteins as well as urothelial sensory protein levels by Western blotting, between SCI patients and 10 controls, as well as successful and failed treatment groups.
15976426|NCT03063814|Behavioral|APP|See arm description
15976427|NCT03063814|Behavioral|PHY|see arm description
15976428|NCT03063801|Other|Data extraction in medical files|Data extraction from medical files, countraverified by the bloodbank database for accuracy.
15976429|NCT03063788|Drug|3BNC117-Copper-64|3 mg/kg 3BNC117 combined with radio-isotope Copper-64
15976430|NCT03063775|Device|BioOss® + Mucograft Seal®|Placement of BioOss®-Collagen into the extraction socket. The Mucograft Seal® Membrane is then applied to the socket.
15976431|NCT03063775|Other|FGG + Bio-Oss®|Placement of BioOss®-Collagen into the extraction socket. The FGG is then attached to the socket.
15976432|NCT03063775|Other|FGG + Gelatine sponge (Spongostan®)|Placement of a Gelatine sponge into the extraction socket, then attaching the FGG to the socket.
15976433|NCT03063775|Device|Spongostan®+ Mucograft® Seal|Placement of a Gelatine sponge into the extraction socket, then attaching the Mucograft® Seal Membrane to the socket
15976434|NCT03063762|Drug|Atezolizumab|"Arms A and B Atezolizumab will be administered at a dose of 840 milligrams (mg) prior to RO6874281 administration as an intravenous (IV) infusion on Days 1, 15, 29, and once in 2 weeks from Day 29 onwards. Doses in the extension part will be based on the maximum tolerated dose determined in the escalation part.
~Arms C and D Atezolizumab will be administered at a dose of 1200mg as it is a Q3W schedule"
15976435|NCT03063762|Drug|Bevacizumab|"Arms A and B Bevacizumab will be administered at a dose of 10 milligrams per kilogram (mg/kg) after the atezolizumab administration, and prior to RO6874281 administration as an IV infusion on Days 15, 29, and once in 2 weeks from Day 29 onwards.
~In Arm D, Bevacizumab will be administered at a dose of 15mg/kg on Day 8 of Cycle 2 and on Day 8 of each consecutive cycle."
15976436|NCT03063762|Drug|RO6874281|"Arms A and B RO6874281 will be administered as an IV infusion on Days 1, 8, 15, 22, and 29, and once in 2 weeks from Day 29 onwards. Starting dose of RO6874281 will be 5 mg, and will be increased subsequently. Doses in the extension part will be based on the maximum tolerated dose determined in the escalation part.
~In Arms C and D, RO will be administered on Q3W schedule at the dose defined in the dose escalation part"
15976438|NCT03063749|Device|Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System|Medtronic Resolute Onyx™ Zotarolimus-Eluting Coronary Stent System, sizes 4.5 mm - 5.0 mm
15976439|NCT03063736|Drug|Entolimod|The objective is to compare adverse events and anti-tetanus (TT) antibody levels between patients getting entolimod vs no entolimod combined with tetanus-diphtheria (Td) vaccine. This clinical trial in 40 normal health subjects compares a single dose of 4 ug Td (2 ug of TT and 2 ug of diphtheria toxoid + 3000 ug of alum) with or without entolimod (1μg).
15976440|NCT03063736|Biological|Td Vaccine|The objective is to compare adverse events and anti-tetanus (TT) antibody levels between patients getting entolimod vs no entolimod combined with tetanus-diphtheria (Td) vaccine. This clinical trial in 40 normal health subjects compares a single dose of 4 ug Td (2 ug of TT and 2 ug of diphtheria toxoid + 3000 ug of alum) with or without entolimod (1μg).
15976441|NCT03063723|Drug|Ledipasvir-Sofosbuvir|8 CHC patients were treated with Sofosbuvir (400mg, qd)/Ledipasvir (90mg, qd) for 12 weeks
15976442|NCT03063723|Drug|Daclatasvir-Sofosbuvir|7 CHC patients were treated with Sofosbuvir (400mg, qd)/Daclatasvir (60mg,qd) for 12 weeks.
15976443|NCT03063710|Drug|olaparib|Initial dose is 300mg twice daily. Study treatment can be dose reduced to 250 mg bd as a first step and to 200 mg bd as a second step. There is no maximum duration for taking study treatment. Patients may continue to receive study treatment until disease progression as assessed by the investigator according to local standard clinical practice or any other discontinuation criteria.
15976444|NCT03063684|Device|Fractional / Pixel CO2 Laser|"The laser energy is transferred in a fractioned manner: the laser beam splits while passing through a lens to 81 dots (9 x 9 pixels) onto approximately 1 cm2, so the laser rays hit the tissue in small spots.
~For gynecological applications, the treatment is performed by a transducer, which was specifically designed for vaginal application."
15976445|NCT03063671|Drug|Ketamine, bupivacine,dexmedetomidine|thoracic epidural catheter insertion at T4-5
15976446|NCT03063658|Drug|Paracetamol|The first dose of 1 gr intravenous paracetamol will be administered preoperatively and the remaining three doses will be given each six hours in the early postoperative period.
15976447|NCT03063658|Drug|Ibuprofen 800 mg|The first dose of 800 mg intravenous ibuprofen will be administered preoperatively and the remaining three doses will be given each six hours in the early postoperative period.
15976448|NCT03063645|Drug|AC-1202|60 g AC-1202 mixed in 240 mL of water at Hour 0 Day 1
15976449|NCT03063645|Drug|AC-SD-01 (50 g)|50 g AC-SD-01 mixed in 240 mL of water at Hour 0 Day 1
15976450|NCT03063645|Drug|AC-SD-01 (75 g)|75 g AC-SD-01 mixed in 240 mL of water at Hour 0 Day 1
15976451|NCT03063632|Biological|Interferon Gamma-1b|Given SC
15976452|NCT03063632|Other|Laboratory Biomarker Analysis|Ancillary studies
15976453|NCT03063632|Biological|Pembrolizumab|Given IV
15976454|NCT03063619|Drug|Afimoxifene|Applied topically
15976455|NCT03063619|Other|Laboratory Biomarker Analysis|Correlative studies
15976456|NCT03063619|Other|Placebo|Applied topically
15976457|NCT03063619|Other|Questionnaire Administration|Ancillary studies
15976458|NCT03063606|Behavioral|Cognitive-Behavioral Therapy (CBT)|CBT specialist treatment
15976459|NCT03063606|Drug|NB Medication (on-going from acute treatment)|Naltrexone/bupropion combination (on-going blinded pharmacotherapy from acute treatment consisting of either naltrexone/bupropion or placebo)
15976460|NCT03063580|Drug|Sotagliflozin (SAR439954)|"Pharmaceutical form: tablets
~Route of administration: oral"
15976461|NCT03063580|Drug|Rifampicin|"Pharmaceutical form: capsules
~Route of administration: oral"
15976462|NCT03063567|Device|CPAP interfaces|All patients in study underwent crossover prospective trial of the same 3 types of CPAP interfaces (nasal mask, oronasal mask, nasal pillows) in randomized order. Trial was 1 month duration for each interface.
15976463|NCT03063554|Procedure|Endoscopic Ultrasound Guided Biliary Drainage|Endoscopic Ultrasound Guided biliary drainage with stent placement;
15976464|NCT03063554|Procedure|ERCP|Endoscopic Retrograde Cholangiopancreatography with transpapillary biliary stent placement
15976465|NCT03063541|Drug|Acetylsalicylic acid|100 mg daily as one tablet
15976466|NCT03063541|Other|intensive blood pressure control|Patients are encouraged to seek any therapy to have a systolic blood pressure of 120 or below. They will be provided with a blood pressure measurement device and are advised to control blood pressure daily.
15976467|NCT03063528|Behavioral|Healthy Eating and Physical Activity|"Participants will be assigned to a group of 8-10 other pregnant women to work towards the same healthy eating or physical activity behavior challenge each week for a total of 12 weeks. The challenges will not require travel or financial support, but will focus on modifying or encouraging daily lifestyle activities, such as drink 8 full glasses of water 3 times this week. Participants will track their healthy eating and physical activity behaviors in a mobile app. The HEPA condition will have access to podcasts and informational tips for having a healthy pregnancy through the study website. The HEPA condition will be able to log their weight on a daily basis and track their overall weight gain on a chart through the study website."
15976468|NCT03063528|Behavioral|Stress Reduction and Management|"Participants will be put into a group of 8-10 other pregnant women to work towards the same stress reduction and management goal each week for a total of 12 weeks. The challenges will not require travel or financial support, but will focus on modifying or encouraging daily lifestyle activities, such as take a 15 minute technology break each day this week. Participants will track their stress reduction and management behaviors in a mobile app. In addition, the SRAM condition will have access to meditation podcasts and informational tips for having a healthy pregnancy through the study website. Lastly, the SRAM condition will be able to rate their stress level on a daily basis and track their stress on a graph."
15976469|NCT03063515|Drug|Pyridostigmine|single oral dose of 60 mg pyridostigmine tablet
15976470|NCT03063489|Drug|Loteprednol Etabonate Ophthalmic Gel|Formulated LE into a gel (loteprednol etabonate ophthalmic gel, [Lotemax® gel])
15976471|NCT03063476|Drug|C-13 labeled Lysine|Carbon-13 is a stable naturally occurring heavy isotope of carbon. Inclusion of a 13C label on lysine allows for subsequent differentiation between endogenous and exogenous lysine and 2-AAA for calculation of clearance and excretion of the lysine bolus.
15976472|NCT03063476|Drug|Normal saline|Because patients will have multiple blood draws during the course of the study, subjects will have an IV placed to reduce the number of needle sticks. To keep the vein open for blood collections, we will infuse Normal (0.9%) Saline (NS) at a rate of approximately 10ml/hr in order to keep the line open.
15976473|NCT03063463|Procedure|pneumatic dilation|Pneumatic dilation of the lower esophageal sphincter (LES) consists of inserting a guide wire under visual control into the stomach and to pass the balloon over the guide wire. The balloon is inflated, disrupting the muscle fibers of the sphincter.
15976474|NCT03063463|Procedure|surgical myotomy|This procedure destroys the muscles at the gastroesophageal junction, allowing the valve (LES) between the esophagus and stomach to remain open.
15976475|NCT03063450|Drug|Nivolumab|Nivolumab at a dose of 240mg as a 30-minute IV infusion, on Day 1 of every 14 day treatment cycle
15976476|NCT03063450|Other|Placebo|Placebo consisting of sterile 0.9% sodium chloride as a 30-minute IV infusion, on Day 1 of every 14 day treatment cycle
15976477|NCT03063437|Biological|Encapsulated fecal microbiota preparation|30 capsules
15976478|NCT03063437|Biological|Encapsulated placebo|30 capsules
15976479|NCT03063424|Diagnostic Test|Eucapnic voluntary hyperventilation|
15976480|NCT03063424|Diagnostic Test|Exercise challenge on a cycle ergometer|
15976481|NCT03063411|Other|Executive Function Intervention|In the executive function training group, children will complete computerised tasks requiring working memory and inhibitory control over four weekly sessions lasting 15-20 minutes. The aim is to improve their executive function skills. In the active control group, children will complete computerised tasks requiring simple decision making and visual search skills over four weekly sessions lasting 15-20 minutes.
15976482|NCT03063411|Other|Active Control Group|This is the active control condition. Children will complete computerised tasks requiring simple decision making and visual search skills over four weekly sessions lasting 15-20 minutes.
15976483|NCT03063398|Diagnostic Test|No intervention, this is an observational study|Assessment for exocrine pancreatic insufficiency
15976484|NCT03063385|Behavioral|Parental Communication intervention|In this intervention, we focus on providing parents with basic knowledge about pregnancy, HIV/AIDS, and STDs as a basis for effectively communicating with their adolescents. We work to support attitudes and develop skills to facilitate communication in general and specifically sexual communication. Based on our prior work we focus on prevention beliefs, reaction beliefs, and communication efficacy. Importantly, we include a component on HIV/AIDS stigma as we conceptualize this to impact attitudes and communication about sex. We will program the intervention in such a way so that parents will have to view the Cuídalos program sequentially and in its totality before being able to review any content.
15976485|NCT03063385|Behavioral|Health promotion control condition|"In this intervention, we provide a web-based program relying on existing Spanish language web-sites to provide participants with helpful information to prevent significant health problems affecting Puerto Rican adolescents that are related, not to sexual behavior, but to other behaviors. Similar to the experimental condition, we will develop a set of homework related to diet and exercise that we will ask parents to complete with their adolescents."
15976486|NCT03063372|Dietary Supplement|Pomella pomegranate extract|Participants will take a 500 mg capsule of pomegranate extract twice daily for 28 days.
15976487|NCT03063372|Other|Placebo|Participants will take a gelatin placebo twice daily for 28 days.
15976488|NCT03063359|Drug|Intranasal fentanyl + Oral Placebo|Administration of intranasal fentanyl (1.5µg/kg) and Oral placebo (NaCl 0.9%) in children with acute pain in traumatic context on arrival in emergency pediatric department.
15976489|NCT03063359|Drug|Oral Morphine + Intranasal Placebo|Administration of oral morphine (0,4mg/kg) and intranasal placebo (NaCl 0.9%) in children with acute pain in traumatic context on arrival in emergency pediatric department.
15976490|NCT03063346|Dietary Supplement|Protein hydrolysate high dose|
15976491|NCT03063346|Dietary Supplement|Protein hydrolysate low dose|
15976492|NCT03063346|Dietary Supplement|Placebo|
15976493|NCT03063333|Other|Coping-oriented hypnosis|Hypnosis using coping-oriented suggestions based on reversal of statements from the pain catastrophizing scale plus current treatment.
15976494|NCT03063333|Other|Neutral hypnosis|Hypnosis using neutral suggestions plus current treatment
15976495|NCT03063320|Other|Spice blend|Test spices include cardamom, coriander, cumin, ginger, paprika, red pepper, turmeric, cinnamon
15976496|NCT03063307|Procedure|Atraumatic Restorative Treatment|
15976497|NCT03063307|Other|Silver Diamine Fluoride|
15976498|NCT03063294|Other|Online Toolkit|The online toolkit provides a set of tools that clinics can use to improve their care coordination processes.
15976499|NCT03063294|Other|Distance-based coaching|The distance-based coach supports included clinics in carrying out a quality improvement project focused on care coordination, either using the online toolkit or other resources determined by the clinic.
15976500|NCT03063281|Other|BIological analysis|Biological analysis : ficolin-2 et anti-ficolin-2 antibodies
15976501|NCT03063268|Behavioral|Trust-Enhanced Messaging on E-Consent|Messaging with trust-enhanced modification to the language that the research team has identified as beneficial additional knowledge to provide to participants. This messaging was reviewed by participants from Phase I and edited as suggested.
15976502|NCT03063268|Behavioral|Interactive features on E-Consent|Interactive hyperlinks to open up to further information for key words that participants from Phase I and prototype design and testing have identified as gaps in subject knowledge and provision of information to subjects.
15976503|NCT03063268|Behavioral|Standard E-Consent|Standard consent currently used by the University of Florida (UF) IRB with no trust-enhanced messaging or interactive hyperlinks that provide further information for subjects.
15976504|NCT03063255|Drug|Obturator block|Subjects allocated to the obturator block group will be monitored for the incidence of block and procedure-related adverse events. In addition to clinical observation, a Nerve Integrity Monitor (Medtronic) will be used to detect adductor spasm using continuous electromyography. Electrodes will be placed on the thigh to objectively detect and record instances of adductor spasm. One hour after arrival to post-anaesthesia care unit (PACU) or when discharge criteria are met (whichever comes first), repeat dynamometer measurements and TUG tests will be performed. Patients will be called 24-48 hours post procedure to inquire about falls or evidence of nerve injury, as well as patient satisfaction.
15976539|NCT03063073|Drug|Dexmedetomidine Injection [Precedex]|ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine (markyrene R sigma -Tec, Egypt) plus (1 µg/kg) Dexmedetomidine Injection [Precedex]
15976540|NCT03063073|Drug|Bupivacaine|
15976541|NCT03063060|Other|vitamin D levels and Calcium levels examination|observational
15976505|NCT03063255|Drug|Neuromuscular block|Subjects allocated to the neuromuscular block group will be monitored for the incidence of block and procedure-related adverse events. In addition to clinical observation, a Nerve Integrity Monitor (Medtronic) will be used to detect adductor spasm using continuous electromyography. Electrodes will be placed on the thigh to objectively detect and record instances of adductor spasm. One hour after arrival to PACU or when discharge criteria are met (whichever comes first), repeat dynamometer measurements and TUG tests will be performed. Patients will be called 24-48 hours post procedure to inquire about falls or evidence of nerve injury, as well as patient satisfaction.
15976506|NCT03063242|Drug|Sargramostim|Study participants (n=5 per project) will receive subcutaneous injection of sargramostim (6 ug/kg) daily until maximal mDC levels are achieved, as determined by a dose response curve.
15976507|NCT03063242|Biological|Blood samples|Blood samples will be drawn at baseline and during each subsequent visit
15976508|NCT03063229|Device|Accelerometer|Attach a monitor to participants thigh to measure their physical activity for 7 days. The monitor is called the Activpal Micro.
15976509|NCT03063229|Other|Anthropomentry|Take skinfold measurements of participants using Harpenden skinfold calipers.
15976510|NCT03063229|Procedure|Blood tests|Taking standard clinical blood tests to measure HbA1c, Glucose, FBC, U&E's, LFT's, Coagulation Screen, Lipid Profile, Thyroid Function, and Tacrolimus for transplant patients.
15976511|NCT03063229|Device|BODPOD|Measure body composition using a BODPOD machine. This uses Air displacement plethysmography.
15976512|NCT03063229|Procedure|MRI (Magnetic Resonance Imaging)|MRI Scans of abdomen, particularly the livers of islet transplant and insulin pump patients.
15976513|NCT03063229|Other|Food Diary|Participants will keep a 7 day weighed food diary.
15976514|NCT03063229|Device|CGMS (Continuous Glucose Monitoring System)|Participants will wear a CGMS for 7 days to measure their glucose control and pattern over a 7 day period.
15976515|NCT03063229|Other|Questionnaire and Hypo Score|Participants with Type 1 Diabetes will fill in 3 short questionnaires about their Diabetes.
15976516|NCT03063229|Procedure|Mixed Meal Tolerance Test (MMTT)|"The patients will under go a test which involves taking 30 minute glucose and C-peptide levels (blood test from a cannula) for 3 hours. They will consume 150ml of a mixed meal supplement drink Fortisip Compact at the start of the 3 hours, after having no morning insulin, breakfast and not eating anything from midnight the night before."
15976517|NCT03063229|Procedure|Indirect Calorimetry|During the Meal Tolerance Test, the patients will be resting on a bed in the research facility and breathing normally into a clear plastic hood. The machine connected to the hood (GEM) will analyse their resting energy expenditure from the gases expired in their breath. They will have the hood on for 2 hours.
15976518|NCT03063229|Drug|Doubly Labelled Water|The Doubly Labelled water will be prescribed for the participants and they will drink their 100ml dose of the stable isotope. Dose depends on the eight of the participant. The participant will then collect urine samples at home on day 5, 10 and 14 after drinking the water. They will store them in the freezer until they can bring them back to us.
15976519|NCT03063229|Drug|Hepatic Mitochondrial Oxidation breath test|Participants will be given a calculated amount of the stable isotope C-Octanoate, which will be delivered in a water solution. They will then be asked to breath down a small tube into a clear plastic collection bag 10 times over 2 hours.
15976520|NCT03063203|Drug|Decitabine|"After 2 cycles, patients with progressive disease or relapse (a clear progression with at least >20% bone marrow blasts and an increase of at least 50% from prior biopsy) should be removed from protocol and proceed to salvage treatment according to center preference
~Transplant eligible patients who achieve CR, CRc, or CRi, after 3 cycles with a suitable donor will proceed to conditioning regimen and transplant
~Transplant eligible patients with PR after 3 cycles may be removed from protocol and proceed to salvage treatment according to center preference
~Transplant eligible patients with a suitable donor who achieve mLFS, CR, CRc, or CRi, may proceed to transplant after at 3 cycles
~Transplant ineligible patients with (CR, CRc or CRi, PR) will continue on maintenance doses
~Transplant ineligible patient with SD after cycle 4 may be removed from protocol and proceed to alternative treatment or continue on protocol according to treating physician's preference."
15976521|NCT03063203|Procedure|Bone marrow biopsy/aspirate|"Baseline, Cycle 1 Day 10, Cycle 1 Day 28, Cycle 2 Day 28, Cycle 3 Day 28, and Progression or relapse
~Biopsy/aspirate on Cycle 1 Day 10 is for participants enrolled at Washington University only
~Biopsy/aspirate on Cycle 2 Day 28 is at the discretion of the treating physician"
15976522|NCT03063203|Procedure|Peripheral blood draw|-Baseline, Cycle 1 Day 10, Cycle 1 Day 28, Cycle 2 Day 28, Cycle 3 Day 28, and Progression/Relapse
15976523|NCT03063203|Procedure|Skin biopsy|"Optional but if refuse skin biopsy then participant can provided buccal swab
~There is no required time frame for this sample - it may have been collected months or even years prior to the first dose of decitabine
~If WBC at time of enrollment is >30,000/µl, skin biopsy should be collected at the time of C1D28 bone marrow biopsy or thereafter"
15976524|NCT03063203|Procedure|Buccal swab|-Baseline (if skin biopsy declined) and Cycle 2 Day 28
15976525|NCT03063190|Drug|Vitamin D|patients will receive vitamin D supplementation according to guidelines
15976526|NCT03063190|Drug|Placebo Oral Tablet|patients will receive placebo oral tablets
15976527|NCT03063177|Procedure|Spinal manipulative therapy|A SMT will be delivered by contacting the transverse processes of T7 through our apparatus. Each participant will receive one SMT per session for 3 sessions.
15976528|NCT03063164|Device|Intralase IFS150|Intralase flap creation
15976529|NCT03063164|Device|Visumax|Visumax flap creation
15976530|NCT03063151|Diagnostic Test|Surface Electromyography (EMG)|
15976531|NCT03063112|Device|Radiofrequency generator device|sympathetic blockade or ablation of thoracic splanchnic nerves
15976532|NCT03063112|Drug|Lidocaine|sympathetic blockade or ablation of thoracic splanchnic nerves
15976533|NCT03063112|Device|C arm fluoroscopic device|sympathetic blockade or ablation of thoracic splanchnic nerves
15976534|NCT03063112|Drug|Ethyl alcohol|sympathetic blockade or ablation of thoracic splanchnic nerves
15976535|NCT03063099|Other|ReNu™ Injection|Injection into the hip for the treatment of Osteoarthritis.
15976536|NCT03063086|Drug|QVM149 150/50/80 μg o.d.|A
15976537|NCT03063086|Drug|QVM149 150/50/160 μg o.d.|B
15976538|NCT03063086|Drug|salmeterol/fluticasone FDC 50/500 μg b.i.d.|C
15976542|NCT03063047|Other|PD21871AA|A 100s size menthol cigarette.
15976547|NCT03063008|Device|PEEK|"Procedure/Surgery:
~TLIF fusion with common PEEK cages."
15976548|NCT03063008|Device|TiPEEK|"Procedure/Surgery:
~TLIF fusion with titanium coated PEEK cages."
15976549|NCT03062995|Other|Infant Formula with added synbiotics|Intervention group: Infant Formula / Follow-On formula with partially hydrolysed cow's milk protein supplemented with prebiotics and probiotics.
15976550|NCT03062995|Other|Standard Infant formula|Control group: Standard Infant Formula / Follow-On formula with intact cow's milk protein (only standard ingredients, without addition of pre- and probiotics).
15976551|NCT03062982|Drug|Fluzoparib|2 doses separated by 7 days.
15976552|NCT03062969|Procedure|Cleavage stage biopsy group|"intracytoplasmatic sperm injection (ICSI)- (Invitro Fertilization)IVF
~Time lapse embryo culture
~Cleavage stage biopsy
~aCGH analysis
~Fresh euploid embryo transfer"
15976553|NCT03062969|Procedure|Trophectoderm biopsy group|"ICSI-IVF
~Time lapse embryo culture
~Day 3 zona pellucida opening
~Trophectoderm biopsy
~aCGH analysis
~Frozen-thawed euploid embryo transfer"
15976554|NCT03062956|Drug|MYK-491 or placebo|Oral suspension
15976555|NCT03062943|Drug|Nintedanib|
15976556|NCT03062930|Behavioral|Track 1|Training of non-paretic arm followed by sham condition
15976557|NCT03062930|Behavioral|Track 2|Same procedures as track 1, but completed in opposite order, starting with sham condition followed by the non-paretic arm training
15976558|NCT03062917|Diagnostic Test|Nasal and Bronchial Sampling|Nasal Absorption sampling, Bronchial sampling, Nasal Pharageal Aspirates, Blood sampling.
15976559|NCT03062904|Drug|Inhaled Bronchodilators +/- Inhaled Methacholine|"Combined Salbutamol 200μg and Ipratropium bromure 80μg (2 inhalations) if paradoxal answer
~Inhaled Methacholine based on international recommendations"
15976560|NCT03062891|Procedure|Online CBT for insomnia|See CBT arm description for information about the CBT intervention. More details can be found in source 4 in the reference list.
15976561|NCT03062878|Other|Arterial blood pressure|Continuously monitored for 5-30 minutes via finger photoplesmography
15976562|NCT03062878|Other|Vascular Ultrasound|Assessment of carotid artery cross sectional area and intima-media thickness. Assessment of brachial artery diameter
15976563|NCT03062878|Other|Venous blood sample|Evaluation of oxidative stress via serum lipid hydroperoxide
15976564|NCT03062878|Other|Skin microcirculatory blood flow|Assessed non-invasively in the forearm skin via Laser Doppler flowmetry in response to locally delivered acetylcholine (ACh) and sodium nitroprusside (SNP) via iontophoresis.
15976565|NCT03062865|Other|No intervention|
15976566|NCT03062852|Device|Medication safety vest|"The nurses preparing and administering medication will wear a medication safety vest. On the back of the vest, the sentance Do not disturb me. I am preparing medications is written to inform others professional, patients and visitors. A informational flyer will be put in the units to inform patients and visitors about the intervention."
15976567|NCT03062839|Drug|Melatonin 5 mg|Melatonin 5 mg taken 30 minutes before bed time
15976568|NCT03062813|Drug|Tacrolimus &entecavir|HBV-GN patients with nephrotic syndrome were randomly givenTacrolimus (0.05-0.1 mg/kg/day) combined with entecavir. Tacrolimus was divided into two daily doses at 12-hour intervals. Subsequent doses were adjusted to achieve a whole blood 12-hour trough level between 5 and 10 ng/ml.All patients will receive entecavir antiviral therapy(0.5mg/d), entecavir was taken once a day. All of HBV-GN patients were followed up to 25week.
15976569|NCT03062813|Drug|placebo & entecavir|HBV-GN patients with nephrotic syndrome were randomly givenTacrolimus placebo (0.05-0.1 mg/kg/day) combined with entecavir.Tacrolimus placebo was divided into two daily doses at 12-hour intervals. All patients will receive entecavir antiviral therapy(0.5mg/d), entecavir was taken once a day. All of HBV-GN patients were followed up to 25week.
15976570|NCT03062800|Drug|Thalidomide|100-200mg/d,oral ,qn
15976571|NCT03062800|Drug|pemetrexed|(500mg/m^2) on day 1 of 21-days cycle,ivgtt
15976572|NCT03062800|Drug|cisplatin|(75mg/m^2) on day 1 of 21-days cycle, ivgtt
15976573|NCT03062800|Drug|carboplatin|(AUC=5) on day 1 of 21-days cycle, ivgtt
15976574|NCT03062787|Device|Cingal® (Hyaluronic Acid plus Triamcinolone Hexacetonide)|Intra-articular injection
15976575|NCT03062787|Device|Monovisc® (Sodium hyaluronate)|Intra-articular injection
15976576|NCT03062774|Biological|PB-119 injection|
15976577|NCT03062761|Other|Infant Formula with prebiotics|Intervention group: Partially hydrolysed whey protein based infant formula containing prebiotics.
15976578|NCT03062761|Other|Standard Infant Formula|Control group: Intact cow's milk protein based infant formula containing prebiotics
15976579|NCT03062735|Other|Inspiratory Muscle Training|The Inspiratory Muscle Training (IMT) group will perform 30 inspiratory efforts, 5 times a week, twice a day, for 12 weeks, against a pressure threshold load equivalent to 50% of maximal inspiratory pressure.
15976580|NCT03062735|Other|Sham Inspiratory Muscle Training|The Sham Inspiratory Muscle Training (Sham-IMT) group will perform 30 inspiratory efforts, 5 times a week, twice a day, for 12 weeks, against a pressure threshold load equivalent to 15% of maximal inspiratory pressure.
15976581|NCT03062722|Procedure|keyhole approach|The surgical procedure was a direct microsurgical approach with a 1.5 cm incision in the thenar sulcus, under local anesthesia (3cc, 2% lidocaine) administered with an insulin needle. The keyhole approach applied to this anatomical region is based on a 1.5 cm skin incision from where the 0.5 cm dissection is completed in the subcutaneous plane in the side borders and 1cm in the distal and proximal borders. Thus, the subcutaneous phase of the dissection is completed with separation of the carpal ligament and resection of its borders. Once the transverse fibers are open, the perineural micro adhesions of the median nerve are resected and 3mm of the free borders of the carpal fibers found on the nerve are removed to avoid fibrosis. The wound is checked for hemostasis and closed in apposition with Vicryl 3-0 and a single subdermal 3-0 Nylon stitch.
15976582|NCT03062709|Behavioral|Breathe Easy Coalition written materials|written materials about secondhand and thirdhand environmental smoke exposure in children
15976583|NCT03062709|Behavioral|Maine Tobacco Helpline|referral to tobacco cessation counselor, helpline calls adult referred to provide counseling over the phone.
15976584|NCT03062709|Diagnostic Test|Urine cotinine testing|the child's urine is tested for cotinine, which is produced when the body absorbs nicotine. These results are communicated to the child's parent/guardian.
15976585|NCT03062696|Behavioral|CBT-RD|5-8 sessions of cognitive behavioral therapy for rumination disorder (CBT-RD), held once per week in an outpatient setting.
15976586|NCT03062683|Other|Lactate, prolactin and creatine kinase conc.|Lactate, prolactin and creatine kinase conc. in blood samples were measured
15976587|NCT03062670|Other|Retreat|Full day off-site training session
15976588|NCT03062657|Device|PRESTIGE LP™ Cervical Disc|The PRESTIGE LP™ Cervical Disc is an artificial cervical disc comprising of two low-profile metal plates that interface through a ball and trough mechanism, permitting segmental spinal motion. The PRESTIGE LP™ Cervical Disc was approved by the Food and Drug Administration (FDA) to be used at a single and two contiguous levels.
15976589|NCT03062644|Drug|MR308|two times daily; Mode of Administration:oral
15976590|NCT03062644|Drug|MR308|four times daily; Mode of Administration:oral
15976591|NCT03062644|Drug|MR308|two times daily; Mode of Administration:oral
15976592|NCT03062644|Drug|MR308|given four times daily to maintain the blind; Mode of Administration:oral
15976593|NCT03062631|Drug|3,4-Diaminopyridine|The investigator will prescribe an initial dose of 3,4 diaminopyridine (DAP) by mouth based on the participant's weight. This initial dose may be modified later according to the participant's response to treatment.
15976594|NCT03062618|Drug|PRCL-02|Oral tablet(s) administered with water
15976595|NCT03062618|Drug|Placebo Oral Tablet|Administered with water
15976596|NCT03062605|Drug|Iodine (Betadine)|
15976597|NCT03062605|Biological|NaOCL|
15976598|NCT03062592|Dietary Supplement|Pine nut oil|Subjects are supplemented with either no oil, hydrolyzed oil or non-hydrolyzed oil in combination with an OGTT
15976599|NCT03062579|Drug|Tocilizumab|Tocilizumab will be intravenously administered as the dosage of 8 mg/kg every 4 weeks, 6 weeks if possible, without concurrent other immunosuppressive treatments.
15976600|NCT03062566|Other|Blood sampling|Blood sampling from peripheral venous catheter routinely inserted in trauma patients during transportation
15976601|NCT03062553|Behavioral|Metacognitive Training (MCT)|MCT is a group-based program developed directly from current cognitive neuropsychiatry research findings on schizophrenia and psychosis. MCT shares knowledge gained in research labs to help individuals experiencing psychosis become more aware of the thinking patterns involved in their illness. The main purpose of the metacognitive training is to help people change the thinking patterns that cause delusions, thereby avoiding relapse into illness or reducing the impact of delusions.
15976602|NCT03062553|Behavioral|Sham/MCT|"The Sham/MCT group will include application of random patterns of low-grade currents to the same brain region as the neuromodulation condition.
~MCT is a group-based program developed directly from current cognitive neuropsychiatry research findings on schizophrenia and psychosis. MCT shares knowledge gained in research labs to help individuals experiencing psychosis become more aware of the thinking patterns involved in their illness. The main purpose of the metacognitive training is to help people change the thinking patterns that cause delusions, thereby avoiding relapse into illness or reducing the impact of delusions."
15976603|NCT03062553|Device|transcranial alternating current stimulation (tACS)|tACS is a non-invasive brain stimulation technique in which a weak electrical current is applied to the head. The current passing through the brain produces small changes in the excitability of the brain regions falling within the current flow. The current occur in an alternating manner (University of California-Berkeley, 2015).
15976604|NCT03062540|Drug|TNX-102 SL|Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks
15976605|NCT03062540|Drug|Placebo SL Tablet|Patients will take 2 tablets of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks
15976606|NCT03062527|Other|Dietary Intervention: Low vs. moderate glycemic index|
15976607|NCT03062514|Device|PINS Vagus Nerve Stimualtor|PINS Vagus Nerve Stimualtor
15976608|NCT03062501|Drug|Hydroxyurea|Patients hospitalized for uncomplicated pain crisis with a pain scale of ≥ 6 during the last 24 hours will receive a dose of 30-40 mg / kg hydroxyurea. This same dose of hydroxyurea will be repeated at 24 h and 48 h after the first dose of hydroxyurea, with dose suspension if the patient is discharged within 48 hours. Patients will also receive the center's usual practice and analgesia protocol.
15976609|NCT03062488|Drug|IV acetaminophen|multi-modal analgesia with IV acetaminophen
15976610|NCT03062488|Drug|Fentanyl|single modal analgesia
15976611|NCT03062488|Drug|PO acetaminophen|multi-modal analgesia with PO acetaminophen
15976612|NCT03062475|Behavioral|lifestyle intervention with dietary and exercise recommendation|"With the dietary intervention we aimed to promote a healthy pattern of eating but not necessarily to restrict energy intake.For example we suggested exchanging carbohydrate-rich foods with a medium-to-high glycaemic index for those with a lower glycaemic index to reduce the glycaemic load, and restricting dietary intake of saturated fat.
~With respect to advice on physical activity, we focused on incremental increases in walking from a pedometer assessed, or encourage them to do moderate cycling during pregnancy."
15976613|NCT03062462|Drug|Clopidogrel|double standard-dose clopidogrel treatment (300 mg loading dose, then 75 mg twice daily) for 5-7 days
15976614|NCT03062462|Drug|ticagrelor|half-dose ticagrelor treatment (90 mg loading dose, then 45 mg twice daily) for 5-7 days
15976615|NCT03062449|Drug|L-Serine|Gummy containing L serine dose
15976616|NCT03062449|Other|Placebo Gummy|Gummy with no dosing of L Serine
15976617|NCT03062436|Other|Stopping the standard drug therpy|Stopping the standard drug therapy of CML patients and monitoring their treatment free remission status
15976618|NCT03062436|Diagnostic Test|Quantitative bcrabl recording every month for first 6 months|Monthly recording of quantitative bcrabl by RQPCR on patients peripheral blood derived RNA. RQPCR will have minimum sensitivity of log4.5
15976619|NCT03062423|Drug|Sofodelevier|1 tablet contains 400 mg sofosbuvir
15976620|NCT03062423|Drug|Sovaldi (fist dose)|1 tablet contains 400 mg sofosbuvir
15976621|NCT03062423|Drug|Sovaldi (second dose)|1 tablet contains 400 mg sofosbuvir
15976622|NCT03062410|Other|Electronic PRO in daily clinical practice|All patients diagnosed with mRCC initiating TKI anti-VEGF treatment (Sunitinib or Pazopanib) will be invited to complete the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 cancer specific questionnaire and the EQ-5D before each visit with the physician. Questionnaires completion will be done by patients on tablets and/or computer terminals via the CHES software (Computer-based Health Evaluation System) at hospital before consultation or at home via secured portal. Physician will immediately have access to a visual summary of HRQOL evaluation.
15976623|NCT03062397|Drug|JPI-289 Low-dose|JPI-289 Low dose will be intravenously administered during 24 hours
15976624|NCT03062397|Drug|JPI-289 High-dose|JPI-289 High dose will be intravenously administered during 24 hours
15976625|NCT03062397|Drug|Placebo|Same dosage of JPI-289 Low and Hogh dose will be intravenously administered during 24 hours
15976626|NCT03062384|Dietary Supplement|AT-001|
15976627|NCT03062384|Dietary Supplement|Placebo|
15976628|NCT03062371|Behavioral|Playgroup|A semi-structured gathering of caregivers and their children in a community setting developed and implemented by a skilled provider.
15976629|NCT03062358|Biological|pembrolizumab|Administered as an intravenous (IV) infusion every 3 weeks (Q3W)
15976630|NCT03062358|Drug|placebo|Normal saline solution administered as an IV infusion Q3W
15976631|NCT03062358|Other|best supportive care (BSC)|BSC will include pain management and management of other potential complications including ascites per local standards of care.
15976632|NCT03062345|Other|Single-User Virtual Reality Upper Extremity Therapy|Virtual Reality games with the user as the only person required for participation
15976633|NCT03062345|Other|Multi-User Virtual Reality Upper Extremity Therapy|Virtual reality games in which more than one user is required for participation. Users interact in the virtual environment.
15976634|NCT03062332|Genetic|Faecal genome|Sequencing faecal genome is not the intervention measure.It is the Observational method to detect the component of faecal microbiota.
15976635|NCT03062319|Drug|Oral Anticoagulant|warfarin, dabigatran, rivaroxaban, apixaban, or edoxaban
15976636|NCT03062319|Drug|Antiplatelet Drug|aspirin, clopidogrel, prasugrel, ticlopidine, or cilostazol
15976637|NCT03062293|Device|Functional Re-adaptive Exercise Device|Exercise intervention 3 times per week for up to 30min. Difficulty and time will be progressed as indicated by clinical presentation, assessed by the Physiotherapist team.
15976638|NCT03062280|Drug|Hydrocortisone|Modified release hydrocortisone
15976639|NCT03062267|Other|Mobile Interventionist|A mobile interventionist is a trained clinician who provides supportive messaging through text messages via mobile devices (i.e. basic / smartphones)
15976640|NCT03062254|Drug|radium-223 dichloride|6 doses of Radium-223
15976641|NCT03062241|Procedure|Cryoablation|After left atrial appendage (LAA) thrombus exclusion, the transseptal puncture will be performed and intravenous heparin will be administered to achieve Activated Clotting Time (ACT) ≥300 seconds.The pulmonary vein (PV) isolation will be performed. Optimal cryoballoon positioning will be confirmed by PVs angiography. Pulmonary veins isolation will be confirmed by entrance/exit block using appropriate catheter. During cryoablation of the right PVs, high-output right phrenic nerve stimulation will be performed using a diagnostic catheter placed in the superior vena cava. Whenever decrease/loss of pacing capture will be observed, cryoablation will be immediately terminated.
15976642|NCT03062215|Behavioral|Space from Depression|Space from Depression programme (Yo puedo sentirme Bien -Spanish version) consists of seven modules of cognitive-behavioural therapy. The treatment includes self-monitoring, behavioural activation, cognitive restructuring, and challenging core beliefs. All modules have the same structure and format, which consist of quizzes, videos, educational content, activities with homework suggestions and a module review page.
15976643|NCT03062202|Behavioral|SilverCloud|SilverCloud Health is a leading provider of online therapeutic solutions to support and promote positive behavior change and mental wellness. SilverCloud delivers interventions for all of the anxiety disorders (panic disorder, social anxiety, phobias, GAD, health anxiety, OCD), depression and also comorbid depression and anxiety. The programs for the treatment of depression and anxiety employ several innovative engagement strategies for improving the user experience. These are divided into several categories: personal, interactive, supportive, and social. Research on the SilverCloud interventions has yielded significant clinical outcomes (Richards et al., 2015).
15976644|NCT03062176|Drug|Anakinra|Anakinra (Kineret)
15976645|NCT03062163|Other|Resveratrol lipoic Acid|Transdermal patch loaded with resveratrol and lipoic acid
15976646|NCT03062163|Other|Placebo|Transdermal patch loaded with normal saline
15976647|NCT03062150|Drug|Placebo|Placebo
15976648|NCT03062150|Drug|Fludrocortisone|Fludrocortisone
15976649|NCT03062150|Drug|D-Cycloserine|D-Cycloserine
15976650|NCT03062137|Diagnostic Test|blood gas sampling|
15976651|NCT03062124|Procedure|SpyGlass pancreatoscopy|During the SpyGlass pancreatoscopy procedure visually guided biopsies and flushing liquid are collected from the pancreatic duct
15976652|NCT03062111|Procedure|ProTouch Laser Enucleation of Prostate (LEP)|Laser enucleation of the prostate is a standard form of treatment for BPH used widely. The ProTouch laser is established to be safe and is newer than the holmium laser.
15976653|NCT03062111|Procedure|Transurethral Resection of Prostate (TURP)|TURP has been considered a gold standard for treatment of BPH in which rigid resectoscopes with bipolar cautery are used to endoscopically resect prostatic tissue.
15976654|NCT03062098|Device|ultrasound imaging|Ultrasound imaging during embryo transfer using a small vaginal probe.
15976655|NCT03062085|Other|Cataract|The genetic and environmental factors concerning to the pathogenesis of cataract in the three groups.
15976656|NCT03062072|Drug|Chemotherapy|Chemotherapy containing glucocorticoid as anti-emetics or anti-cancer agent except for targeted agents
15976657|NCT03062059|Drug|Intravesical 2000mg/52.6ml gemcitabine instillation|Intravesical 2000mg/52.6ml gemcitabine instillation during operation to prevent intravesical recurrence after radical nephroureterectomy in upper urinary tract urothelial carcinoma
15976658|NCT03062046|Device|RF ablation|RF ablation
15976659|NCT03062020|Device|QUIPP|Information required by QUIPP tool will be introduced ( obstetrical history, cervical length and quantitative fetal fibronectin value) and a percentage of risk of preterm birth will be given. Women with a high-risk value will be managed in Preterm Birth Prevention Clinic and women with low-risk value will be followed-up in a low-risk unit.
15976660|NCT03062007|Drug|BI-CON-02|BI-CON-02 prescribed as intravenous infusion once per 3 weeks. Investigational product therapy during 1 year (up to 18 cycles, duration of 21 days each).
15976661|NCT03061981|Drug|Placebo|After pre-dose assessments on Day 1, subjects will receive a single oral dose of IMP after an overnight fast in each Treatment Period.
15976708|NCT03061643|Drug|Docetaxel|docetaxel 40 mg/m2 IV every 2 weeks plus ADT
15976662|NCT03061981|Drug|Metformin|Subjects in the IE cohort will receive 500 mg metformin (IR formulation) at 12 hours on Day 1 and a single oral dose of the IMP with 500 mg metformin (IR formulation) after an overnight fast on Day 1, in Treatment Period 2.
15976663|NCT03061981|Drug|DA-1241|After pre-dose assessments on Day 1, subjects will receive a single oral dose of IMP after an overnight fast in each Treatment Period .
15976664|NCT03061968|Behavioral|acupressure|The babies in experimental group will be observed for one day, and then intervene the simplified acupressure three times a day for fifteen days, and continuously recoding the observation and records until discharge.
15976665|NCT03061955|Biological|influenza vaccination|administration of influenza vaccination
15976666|NCT03061942|Other|Arthroscopic rotator cuff repair without synovectomy|30 subjects will undergo conventional arthroscopic rotator cuff repair without synovectomy.
15976667|NCT03061942|Other|Arthroscopic rotator cuff repair with synovectomy|30 subjects will undergo arthroscopic rotator cuff repair with synovectomy. Synovectomy is an operation performed to remove inflamed synovial membrane of a joint. Arthroscopic synovectomy will be performed with the use of a shaver and a cautery device through the portals for arthroscopic rotator cuff repair.
15976668|NCT03061916|Dietary Supplement|Cinnamon|Cinnamon 20% will be given to participants after baseline collection of saliva
15976669|NCT03061916|Dietary Supplement|Ginger|Ginger 20% will be given to participants after baseline collection of saliva
15976670|NCT03061916|Drug|Chlorhexidine Gluconate|Chlorhexidine Gluconate will be given to participants after baseline collection of saliva
15976671|NCT03061903|Device|Prevena|"Closed Incision Negative Pressure Therapy (bandage over the incision sealed with negative pressure of a vacuum) to be placed on after surgery for 7 days.
~Prevena™, by KCI, is currently being used selectively in high-risk patients and a FDA-approved device."
15976672|NCT03061903|Device|Aquacel|"Water resistant, silver-impregnated, antimicrobial hydrofiber dressing that is placed on after surgery for 7 days.
~AQUACEL® Ag, by Convatec, is currently the standard of care for postoperative wound dressing and a FDA-approved device."
15976673|NCT03061877|Other|Anxiety or depression|The presence of anxiety or depression measured by the Hospital Anxiety and Depression Scale (HAD)
15976674|NCT03061864|Behavioral|Periviable Birth Plan|
15976675|NCT03061851|Behavioral|conventional treatment|the treatment plan by the investigators according to the patient's condition may be, this study does not interfere.
15976676|NCT03061851|Other|Maltose app|"Weekly diabetes-related science articles.
~Patients reported hypoglycemia or other adverse reactions, the competent physician to deal with.
~Questionnaires published out the hospital (2 weeks 1), the feedback for the problem.
~monitoring of abnormal blood glucose data or the presence of related discomfort, can communicate with the competent physician online.
~Personalize the development of diet, exercise program.
~different insulin and oral hypoglycemic drug medication time to remind.
~hypoglycemic drug side effects query."
15976677|NCT03061838|Drug|MabThera®|1000 mg intravenously
15976678|NCT03061838|Drug|Ritumax®|1000 mg intravenously
15976679|NCT03061825|Device|Zenith Alpha™ Abdominal Endovascular Graft|Zenith Alpha™ Abdominal Endovascular Graft for the treatment of abdominal aortic or aorto-iliac aneurysm.
15976680|NCT03061812|Drug|Rovalpituzumab tesirine|Powder for solution for infusion in vials.
15976681|NCT03061812|Drug|Topotecan|Powder or solution for infusion in vials. Topotecan is commercially available as both a powder and solution for infusion. Availability will vary by region.
15976682|NCT03061812|Drug|Dexamethasone|Oral tablet.
15976683|NCT03061799|Dietary Supplement|HPC-03|HPC-03 is extracts of danggui (angelica gigas nakai), taeunggung (cnidium rhizome), and broilers (cinnamon bark).
15976684|NCT03061799|Dietary Supplement|Placebo|Placebo is constituted of crystalline cellulose(50.5%), corn starch(33.10%), caramel color(1.90%), anhydrous citric acid(1.25%), silicon dioxide(1.90%), carboxymethylcellulose calcium(6.25%), magnesium stearate(2.50%), and coater (3.10%).
15976685|NCT03061773|Other|Exercise|Physical training: The combined training program consisted of 12-week aerobic, resistive and flexibility exercises, with 3 sessions per week of aerobic and resistive training in the same session (supervised by physical exercise coaches) and 2 sessions per week of Flexibility training (unsupervised). As stretching sessions were interspersed with sessions of aerobic and weathered training in the daytime period.
15976686|NCT03061773|Behavioral|Conventional hospital treatment|Conventional hospital treatment: The patients did not perform physical training
15976687|NCT03061760|Procedure|Radical prostatectomy|Radical prostatectomy due to prostate cancer.
15976688|NCT03061760|Diagnostic Test|Initial evaluation|Questioners, Ultrasound, Uroflowmetry
15976689|NCT03061760|Diagnostic Test|Evaluation after 1,3,6,9,12 months|Questioners, Ultrasound, Uroflowmetry
15976690|NCT03061747|Device|Assesment of outcome of implantable device patients|Evaluation during follow-up of the occurrence of atrial arrhythmias, hospitalizations, and of death.
15976691|NCT03061734|Drug|Naltrexone and Acetaminophen|Naltrexone plus acetaminophen
15976692|NCT03061734|Drug|Naltrexone and Acetaminophen-High Dose|Naltrexon (high dose) plus acetaminophen
15976693|NCT03061734|Drug|Naltrexone Alone (regular dose)|Naltrexone Alone plus Placebo
15976694|NCT03061734|Drug|Acetaminophen Alone|Acetaminophen Alone plus Placebo
15976695|NCT03061734|Drug|Matching Placebo|Two Placebo capsules
15976696|NCT03061721|Drug|Saroglitazar magnesium 1 mg|Patients randomly assigned to this group will receive Saroglitazar magnesium 1 mg tablet orally once daily for 16 weeks.
15976697|NCT03061721|Drug|Saroglitazar magnesium 2 mg|Patients randomly assigned to this group will receive Saroglitazar magnesium 2 mg tablet orally once daily for 16 weeks.
15976698|NCT03061721|Drug|Saroglitazar magnesium 4 mg|Patients randomly assigned to this group will receive Saroglitazar magnesium 4 mg tablet orally once daily for 16 weeks.
15976699|NCT03061721|Drug|Placebos|Patients randomly assigned to this group will receive placebo tablet orally once daily for 16 weeks.
15976700|NCT03061708|Drug|AZD2014|mTOR inhibitor
15976701|NCT03061682|Device|"Scharioth macula lens A45sml/A45smy"|Implantation of an add on intraocular lens to low vision patients
15976702|NCT03061656|Drug|Cyclophosphamide|1st HDCT
15976703|NCT03061656|Drug|Carboplatin|1st HDCT
15976704|NCT03061656|Drug|Etoposide|1st HDCT
15976705|NCT03061656|Radiation|131I-MIBG|2nd HDCT
15976706|NCT03061656|Drug|Thiotepa|2nd HDCT
15976709|NCT03061643|Other|Androgen-Deprivation Therapy (ADT)|docetaxel 40 mg/m2 IV every 2 weeks plus ADT
15976710|NCT03061630|Drug|Gemcitabine|D1.8.15 : GEMCITABINE 1000MG/M2
15976711|NCT03061630|Drug|Cisplatin|D1: CISPLATIN 60G/M2
15976712|NCT03061617|Other|VCV mode|set fixed 6ml/kg tide volume
15976713|NCT03061617|Other|PCV mode|adjust pressure to achieve tide volume of 6ml/kg
15976714|NCT03061604|Device|Hemospray|Hemospray is a novel hemostatic powder licensed for endoscopic hemostasis of non-variceal upper gastrointestinal bleeding which has been shown to be effective in preliminary studies for the management of patients with peptic ulcer bleeding, including those on anticoagulant or antithrombotic therapy . Recently, two case reports and a pilot study reported that hemostatic powder may be useful in emergency management of variceal bleeding as a bridge towards more definitive therapy
15976715|NCT03061604|Drug|Octreotide|"Octreotide will be administered to all patients at time of admission and will be continued for 24 hours
~• Dosage: 50 mcg bolus at admission then 25 mcg/hour"
15976716|NCT03061604|Biological|Blood transfusion|Blood transfusion will be administered to all patients if needed
15976717|NCT03061604|Drug|Ceftriaxone|Ceftriaxone will be administered to all patients on daily basis
15976718|NCT03061591|Dietary Supplement|Wholistic Turmeric capsules|Oral capsules of wholistic Turmeric capsules (Pukka herbs) curcumin (each capsule 0.5100 m gr curcumin) for a total of 4 gr/d divided twice daily.
15976719|NCT03061591|Other|Placebo|Placebo capsules
15976720|NCT03061578|Diagnostic Test|Tear Film Imager|Ocular surface imaging assessment by the Tear Film Imager (TFI)
15976721|NCT03061578|Diagnostic Test|Low Humidity Environmental Exposure Chamber (LH-EEC)|Subjects will enter the LH-EEC (<15% relative humidity (RH), temperature 22±5ºC, and 5±3ft/s directed air flow velocity) and remain for approximately 120 min.
15976722|NCT03061565|Drug|erythropoietin|Patients were given erythropoietin during the EPO-TBI study in 2010-2014. In the current follow-up we will evaluate any possible long term differences between patients treated with etrythropoietin compared to placebo.
15976723|NCT03061565|Drug|Placebos|Patients were given placebo during the EPO-TBI study in 2010-2014. In the current follow-up we will evaluate any possible long term differences between patients treated with etrythropoietin compared to placebo.
15976724|NCT03061552|Diagnostic Test|sonographic measurement of inferior vena cava diameter|pre-dialysis measurement of inferior vena cava diameter using echocardiography
15976725|NCT03061539|Drug|Nivolumab & Ipilimumab|"Nivolumab 1 mg/kg + ipilimumab 3 mg/kg every three weeks for a maximum of 4 doses.
~6 week gap after last combination dose.
~480 mg flat dose of nivolumab every 4 weeks for up to one year, or until progression, unacceptable toxicity or withdrawal of consent."
15976726|NCT03061526|Other|optical coherence tomography|measurement of reflectivity in different retinal layers based on optical coherence tomography findings
15976727|NCT03061513|Drug|Ubiquinol|Ubiquinol caplets 600mg/day
15976728|NCT03061513|Dietary Supplement|Placebo|placebo
15976729|NCT03061487|Procedure|Open Surgical Treatment of Aneurysm (Aneurysmectomy)|Aneurysmectomy is a surgical procedure in which a localized, dilated, weakened section of an artery (aneurysm) is removed (resected). The artery is either replaced with a synthetic graft, as seen in an aneurysm in the chest (thoracic aneurysm), abdomen (abdominal aneurysm) or leg (femoral or popliteal aneurysm).
15976730|NCT03061474|Drug|Nicotinamide|Niacinamide (nicotinamide; 99%) is produced in a 750 mg sustained release tablet.
15976731|NCT03061474|Drug|Placebo Comparator|Oral Tablet
15976732|NCT03061461|Device|rESWT|"All patients will receive standard care as follows:
~Wounds will be cleaned with distilled water and applied with collagen gel or collagen sheet on the wound and then closed with foam/gauze or gamgee.
~The clean wounds will be assessed using the TIME concept.
~Treatment with rESWT.
~Subsequently the wounds will be cleansed with distilled water, and collagen and glycerine gel will be applied and covered with adhesive dressings (Melolin, Smith & Nephew, Inc. Advanced Wound Management; Fort Worth, TX, USA).
~In addition, patients in arm rESWT will receive rESWT between Steps 2 and 3 of standard care as outlined in arm description rESWT."
15976733|NCT03061461|Device|Sham rESWT|"All patients will receive standard care as follows:
~Wounds will be cleaned with distilled water and applied with collagen gel or collagen sheet on the wound and then closed with foam/gauze or gamgee.
~The clean wounds will be assessed using the TIME concept.
~Treatment with sham rESWT.
~Subsequently the wounds will be cleansed with distilled water, and collagen and glycerine gel will be applied and covered with adhesive dressings (Melolin).
~In addition, patients in arm Sham rESWT will receive sham rESWT between Steps 2 and 3 of standard care as outlined in arm description Sham rESWT."
15976734|NCT03061448|Behavioral|Internet-based cognitive-behavior therapy|Internet-based cognitive-behavior therapy on a safe internet platform. Treatment is divided into eight modules, each containing homework assignments . The participants will be assigned a therapist that they can contact through a message system in the platform and expect answer within 24 hours.
15976735|NCT03061435|Procedure|Screening anal Pap smear - No high-resolution anoscopy|75% of patients with negative cytology on their anal Pap smear will not receive high-resolution anoscopy
15976736|NCT03061435|Procedure|Screening anal Pap smear - High-resolution anoscopy|25% of patients with negative cytology on their anal Pap smear will receive high-resolution anoscopy. All patients with positive (abnormal) cytology on their anal Pap smear will receive high-resolution anoscopy.
15976737|NCT03061422|Other|Xylitol|caries prevention chewing gum
15976738|NCT03061422|Other|xylitol with bicarbonate|caries prevention chewing gum
15976739|NCT03061422|Other|paraffin|chewing gum
15976740|NCT03061409|Dietary Supplement|Pharmavite Nature Made Multi for Him 50+|To examine whether one tablet a day of Pharmavite Nature Made Multi for Him 50+ will increase micro-nutrient status in older people taking multiple medications as compared to placebo
15976741|NCT03061409|Dietary Supplement|Placebo|served as placebo
15976742|NCT03061396|Other|Matching points PC6+CV12|Choose both Neiguan(PC6) and Zhongwan point(CV12).The needles are connected through a electro-acupuncture apparatus, the positive poles are linked to the needle, and the reference poles are located near the acupoint about 1cm with a electrode.Frequency is 2/10 hertz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10 milliampere. And plus 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron, Tropisetron，Granisetron or Ondansetron) and dexamethasone.
15976790|NCT03061058|Drug|Oxaliplatin|intravenous
15976743|NCT03061396|Other|Single points PC6|Choose Neiguan(PC6)of double upper limb.The needles are connected through a electro-acupuncture apparatus, the positive poles are linked to the needle, and the reference poles are located near the acupoint about 1cm with a electrode.Frequency is 2/10 hertz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10 milliampere. And plus 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron, Tropisetron，Granisetron or Ondansetron) and dexamethasone.
15976744|NCT03061383|Other|8% Arginine based toothpaste|toothpaste
15976745|NCT03061383|Other|8% strontium acetate based toothpaste|toothpaste
15976746|NCT03061383|Other|placebo|toothpaste
15976747|NCT03061370|Procedure|Esophagectomy or Gastrectomy|Surgical resection
15976748|NCT03061357|Behavioral|Activity tracker|Misfit Flash (Misfit Wearables Co., Burlingame, CA) activity tracker
15976749|NCT03061344|Biological|DVIU treated with liquid buccal mucosal graft|DVIU treated with liquid buccal mucosal graft; internal urethrotomy for urethral stricture followed by injection of morcellated buccal mucosal graft mixed with fibrin glue (Tisseel, Baxter)
15976750|NCT03061331|Drug|LUM/IVA|LUM 400 mg/IVA 250 mg every 12 hours (q12h)
15976751|NCT03061331|Drug|Placebo|No Active Drug
15976752|NCT03061292|Procedure|Pectoral Nerve Block|
15976753|NCT03061292|Procedure|Without Pectoral Nerve Block|
15976754|NCT03061279|Device|Fixation by Acutrak headless screw|The fixation provided by the Acutrak headless compression screws provide sufficient fixation to achieve union and a favorable clinical outcome in both horizontal and vertical medial malleolus fractures when compared to bicortical and unicortical screw fixation, tension band wiring, and mini-fragment or buttress plating
15976755|NCT03061279|Device|Fixation by headed screws, plates, and or wires|DePuy-Synthes Cannulated Cancellous Screws, DePuy-Synthes Cancellous Screws, DePuy-Synthes Cortical Screws, DePuy-Synthes 1/3 Tubular Plate, DePuy-Synthes Locking contrast dynamic compression (LC-DCP) Plate, DePuy-Synthes Pre-contoured Plate, and/or 18g Wire are the alternative methods of treatment of medial malleolus fracture.
15976756|NCT03061266|Behavioral|E-health Education|E-health education on shared care program will be established by different type's professionals including diabetes physicians, pharmacists, dietitians and diabetes health teacher.
15976757|NCT03061266|Other|Routine care|Routine care on shared care program as advised by clinical professionals, which included medications, dietary control and general physical activities.
15976758|NCT03061253|Other|Electronic Cigarette and behavioural change support.|The nicotine strength of Group A (nicotine-inclusive e-cigarettes) cartridges will be 18 mg/ml of nicotine strength. All participants will receive up to 6 behavioural change support sessions over the 3-month intervention period.
15976759|NCT03061253|Other|Nicotine-Free Electronic Cigarette and behavioural change support.|Group B participants will receive nicotine-free cartridges for the period of the intervention. All participants will receive up to 6 behavioural change support sessions over the 3-month intervention period.
15976760|NCT03061253|Other|Nicotine Replacement Therapy and behavioural change support.|Group C participants will be referred to smoking cessation services where they will be expected to receive Nicotine Replacement Therapy and up to 6 behavioural change support sessions over the 3-month intervention period, as per current guidelines.
15976761|NCT03061240|Device|Smart pain assessment tool|We record and analyze multiple bio-signals from post-operative patients in the attempt to evaluate their experienced pain.
15976762|NCT03061227|Drug|Intravenous glucagon|Randomized application of glucagon or saline during oral glucose tolerance test
15976763|NCT03061227|Drug|Intravenous saline|Randomized application of glucagon or saline during oral glucose tolerance test
15976764|NCT03061214|Drug|Semaglutide 0.5 mg|Up to 0.5 mg semaglutide injected subcutaneously (s.c., under the skin) once-weekly (OW) for 30 weeks
15976765|NCT03061214|Drug|Semaglutide 1.0 mg|Up to 1.0 mg semaglutide injected subcutaneously once-weekly for 30 weeks
15976766|NCT03061214|Drug|Sitagliptin placebo|Sitagliptin placebo tablets taken once-daily for 30 weeks
15976767|NCT03061214|Drug|Sitagliptin|100 mg sitagliptin tablets taken once-daily for 30 weeks
15976768|NCT03061214|Drug|Semaglutide placebo 0.5 mg|Semaglutide placebo (0.5 mg) injected subcutaneously once-weekly for 30 weeks
15976769|NCT03061214|Drug|Semaglutide placebo 1.0 mg|Semaglutide placebo (1.0 mg) injected subcutaneously once-weekly for 30 weeks
15976770|NCT03061201|Biological|SB-525 (PF-07055480)|Single dose of investigational product SB-525 (PF-07055480)
15976771|NCT03061188|Other|Laboratory Biomarker Analysis|Correlative studies
15976772|NCT03061188|Biological|Nivolumab|Given IV
15976773|NCT03061188|Other|Pharmacological Study|Correlative studies
15976774|NCT03061188|Drug|Veliparib|Given PO
15976775|NCT03061175|Other|Internet-Based Intervention|Receive web-based CPM-DA
15976776|NCT03061175|Other|Survey Administration|Ancillary studies
15976777|NCT03061162|Radiation|pulsed low dose rate radiation therapy|Pulsed low dose rate 3-dimensional conformal radiation therapy
15976778|NCT03061149|Other|Low-level laser therapy|
15976779|NCT03061149|Other|Ultrasound treatment|
15976780|NCT03061136|Drug|Clonazepam|
15976781|NCT03061136|Drug|Placebo|
15976782|NCT03061123|Other|Questionnaire|
15976783|NCT03061110|Biological|Stromal Vascular Fraction|Stromal Vascular Fraction will be produced from the subject's own adipose tissue by the Tissue Genesis Icellator device.
15976784|NCT03061110|Other|Usual Care|Usual care will include over-the-counter and prescription methods to treat xerostomia.
15976785|NCT03061097|Biological|Autologous fecal microbiota transplant (Auto-FMP Enema)|FMT is the process by which processed donor microbiota material is transplanted into recipients. The aim is to reconstitute the normal intestinal microbial flora in recipients. In this study, the fecal microbiota preparation will be made from the participant's own stool and processed into an auto-FMP enema formulation.
15976786|NCT03061097|Other|Placebo Enema Preparation|The placebo enema preparation will be identical in appearance but will not contain human feces to prevent unmasking of the trial arms.
15976787|NCT03061071|Device|NightBalance Sleep Position Trainer (SPT)|Subject to sleep with the SPT for a 6 week home use period followed by in-lab PSG.
15976788|NCT03061071|Device|Automated Adjusting Positive Airway Pressure (APAP)|Subject to sleep with the APAP for a 6 week home use period followed by in-lab PSG.
15976789|NCT03061058|Drug|Docetaxel|intraperitoneal and/or intravenous
15976795|NCT03061045|Drug|Sulfur Hexafluoride Lipid Type A Microspheres 25 MG Intravenous Powder for Suspension [LUMASON]|All patients enrolled in this study will undergo contrast enhanced ultrasound examination for assessment of brain perfusion.
15976796|NCT03061032|Drug|Sofosbuvir/Ledipasvir 12W|Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 12 weeks.
15976797|NCT03061032|Drug|Sofosbuvir/Ledipasvir plus Ribavirin 12W|Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 12 weeks.
15976798|NCT03061032|Drug|Sofosbuvir/Ledipasvir 24W|Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) for 24 weeks.
15976799|NCT03061032|Drug|Sofosbuvir/Ledipasvir plus Ribavirin 24W|Daily fixed dose combination of Sofosbuvir (400mg)/Ledipasvir (90 mg) plus Daily Ribavirin (1000-1200 mg) for 24 weeks.
15976800|NCT03061019|Procedure|Oral Myofunctional Therapy with exercices|Oral-Motor training of oral muscles (tongue, lips) associated with nasal hygiene with daily repetition of exercices and parental support.
15976801|NCT03061019|Procedure|Oral Myofunctional Therapy with soft oral appliance|Ora-Motor training of oral muscles (tongue, lips) associated with nasal hygiene, with reduced parental support.
15976802|NCT03061006|Drug|Dabigatran Etexilate|150 mg BID (CrCL > 30 mL/min) or 75 mg BID (CrCL > 15 to 30 mL/min); Assessment of kidney function every 6 months.
15976803|NCT03061006|Drug|Warfarin|Dose-adjusted (INR 2.0 - 3.0); Standard warfarin follow-up and education based upon system criteria.
15976804|NCT03060993|Drug|Cannabis|Patients will be administered cannabis (THC/CBD) in vaporized form.
15976805|NCT03060993|Drug|Placebo|Patients will be administered placebo (cannabis stripped of cannabinoids) in vaporized form.
15976806|NCT03060980|Drug|ITCA 650 20/60 mcg/day|ITCA 650 osmotic mini-pump delivering exenatide 20/60 mcg/day
15976807|NCT03060980|Drug|Empagliflozin (oral)|10 mg/day and 25 mg/day
15976808|NCT03060980|Drug|Glimepiride (oral)|1-6 mg/day
15976809|NCT03060967|Behavioral|Computer-based tasks|Computer-based tasks designed to assess size and time discrimination capacities of food and control images
15976810|NCT03060954|Device|MINI WELL READY ®|BILATERAL IMPLANTATION OF MINI WELL READY®, A PROGRESSIVE EXTENDED DEPTH OF FOCUS INTRAOCULAR LENS IN PATIENTS WITH CATARACT SURGERY
15976811|NCT03060954|Device|FINE VISION®|FINE VISION®, A TRIFOCAL INTRAOCULAR LENS IMPLANTATION IN PATIENTS WITH CATARACT SURGERY
15976812|NCT03060941|Behavioral|Physical activity education|Participants will be given educational materials on how to increase physical activity levels.
15976813|NCT03060941|Behavioral|Facility access|Participants will receive at 6 month membership to a local fitness facility.
15976814|NCT03060941|Behavioral|Supervised exercise sessions|Participants will attend weekly supervised exercise sessions with an exercise interventionist.
15976815|NCT03060941|Behavioral|Self-monitoring (Fitbit)|Participants will be given a Fitbit to monitor their physical activity levels.
15976816|NCT03060941|Behavioral|Active living counseling|Participants will attend 12 biweekly educational sessions about how to increase their physical activity levels.
15976817|NCT03060928|Procedure|Arthroscopic Rotator Cuff Repair|Arthroscopic Rotator Cuff Repair
15976818|NCT03060928|Procedure|Micro-perforations|Biological stimulation with micro-perforations
15976819|NCT03060928|Procedure|Artelon®|Biological stimulation with Artelon® Tissue Reinforcement
15976820|NCT03060915|Device|Polysomnography|Patient's undergo a polysomnography
15976821|NCT03060915|Device|Actigraphy|Patient's wear an actigraphy while doing the polysomnography
15976822|NCT03060902|Behavioral|Dialectical Behavior Therapy Skills|DBT Skills Training will follow the DBT Skills Training Manual Second Edition and the DBT Skills Training Handouts and Worksheets Second Edition.
15976823|NCT03060889|Drug|Tranexamic acid|10 mg/kg body weight will be given with induction of anesthesia by intravenous infusion
15976824|NCT03060863|Behavioral|2. Executive Functioning|Interventions will occur in 3 biweekly visits plus technology-based practice. The investigators will use computer-based working memory training to improve Executive Functioning (EF) and will use a working memory training game that has been used with children this age (N-back task).
15976825|NCT03060863|Behavioral|3. Food Bias|The investigators will use attention-bias retraining techniques that have been tested in adults that have children practice approach and avoidance attentional strategies using a joystick and food images (healthy and unhealthy foods). Interventions will occur in 3 biweekly visits. Children in this arm will use a computer-based approach avoidance task to reduce attentional biases for food by using a joystick to push away images of nonhealthy foods and pull closer images of healthy foods.
15976826|NCT03060863|Behavioral|4. Emotion Regulation|Interventions will occur in 3 biweekly visits plus home practice. The investigators will use assisted relaxation training where children are trained to monitor and control their heart rate and skin conductance using biofeedback in a computer-game context (Journey to Wild Divine).
15976827|NCT03060863|Behavioral|5. Future orientation|"Interventions will occur in 3 biweekly visits. Children will participate in an interview protocol designed to enhance their capacity to visualize upcoming future events and describe them in detail, with the goal to make the future become present."
15976828|NCT03060850|Drug|AC0010MA|Participants in the dose escalation cohorts will be treated with AC0010MA every 28 days
15976829|NCT03060837|Diagnostic Test|Preoperative Parameters|Preoperative Hmg and serum creatinine levels
15976830|NCT03060837|Other|Peroperative Parameters|Scope duration, perforation, hemorrhage, etc. complications
15976831|NCT03060837|Other|Postoperative Parameters|Stone-free rates, complications like postoperative hemorrhage and fever, hospital stay, etc
15976832|NCT03060837|Other|Movement of kidney|Changes in renal stone position during simultaneous normal ventilation and single lung ventilation.
15976833|NCT03060837|Procedure|single lung ventilation|Patients in this group will intubated with an endotracheal tube and then a bronchial blocker will be placed with the help of a fiberoptic bronchoscope or will be intubated with a double lumen endobronchial tube. One lung ventilation will be applied
15976834|NCT03060837|Procedure|standard ventilation|Patients in this group will be intubated with standart single lumen endotracheal tubes and standart two lung ventilation will be applied.
15976835|NCT03060824|Other|Blood sampling|To explore changes in osmolality during coronary artery bypass grafting surgery with the aid of Cardiopulmonary Bypass by repeated measurements of osmolality and concentration shifts of sodium, glucose and urea in plasma.
15976837|NCT03060798|Device|Near-infrared spectroscopy monitor|tissue oxygen saturation monitoring combined with vessel occlusion test
15976838|NCT03060785|Drug|Tenofovir Disoproxil Fumarate/Emtricitabine|
15976839|NCT03060772|Drug|Pioglitazone|Participants will take 30 mg of pioglitazone once daily for a total of two to four weeks for those randomized to therapy, until the next bronchoscopy is performed. Participants will receive 14 to 28 tablets of active pioglitazone, which is enough to complete the minimum 14-day course of therapy.
15976840|NCT03060759|Device|Light Therapy box|"The light box used for LT (SunRay by The Sunbox Company, Gaithersburg, Maryland, USA) is approximately 15.5 tall x 23 wide x 3.25 deep and is designed to stand on a desk or tabletop. It can be used both in the home or office. The light is delivered at a downward angle to maximize the effectiveness. The box runs on 124 watts and contains full spectrum 5000k 10,000 lux bulbs."
15976841|NCT03060746|Other|Newly Diagnosed|Gastric biopsy tested by composite reference method (CRM) (histology, urease, culture) and stool sample
15976842|NCT03060733|Other|Post-Therapy|Gastric biopsy tested by composite reference method (CRM) (histology, urease, culture) and stool sample
15976843|NCT03060707|Drug|Rocuronium Bromide|Continuously infuse, or bolus administer rocuronium.
15976844|NCT03060694|Other|diabetes|"a history of diabetes and using anti-diabetic medicines.
~fasting serum glucose level greater than 7.1mmol/L, or glycosylated hemoglobin percentage greater than 6.5%."
15976845|NCT03060681|Drug|Bupivacaine 0.5% injected in the thoraco-lumber inetrfacial plane block|After attaching basic monitors (ECG, SpO2, NIBP), the patient will take the prone position. Using the superficial probe of the ultrasound machine, the probe will be placed in transversally in midline position at selected level. The spinous process and interspinalis muscles will be identified. The probe was then moved laterally to identify the mulifidus muscle (MF) and the longissimus muscles (LG) where the local anesthetic will be injected. The needle will be advanced under real-time in-plane ultrasound guidance till it reaches the interface between the two muscles then a 1-2 ml of saline will be inserted to confirm needle site. 15 ml of bupivacaine 0.25 will be injected each side.
15976846|NCT03060668|Other|Peptamen intense|Study group will receive a nutritional formula containing 1.0 kcal/ml and 93 g/L of protein
15976847|NCT03060668|Other|Novasource senior|Control group will receive a nutritional formula containing 1.2 kcal/ml and 65 g/L of protein
15976848|NCT03060655|Biological|PLGA-Mg material|The PLGA-Mg material was used to accomplish the fixation of fragments. Then, the clinical outcome was assessed.
15976849|NCT03060655|Biological|titanium alloy|Traditional fixation was titanium alloy. the clinical outcome was assessed.
15976850|NCT03060642|Device|Tethered capsule sponge|Subjects swallow a tethered capsule sponge sampling device, which is then withdrawn through the mouth after an interval of 5 minutes.
15976851|NCT03060642|Device|Electronic nose device|Subjects breathe into the device, which then records an exhaled volatile organic compounds (VOC) signature.
15976855|NCT03060603|Drug|Erythropoietin|Recombinant Human Erythropoietin, three times in a week, until the correction of anemia, approximately two months.
15976856|NCT03060577|Drug|Inclisiran|Inclisiran is a synthetic, chemically modified small interfering ribonucleic acid (siRNA) targeting proprotein convertase subtilisin kexin type 9 (PCSK9) messenger ribonucleic acid (mRNA) with a covalently attached triantennary N-acetylgalactosamine (GalNAc) ligand.
15976857|NCT03060577|Drug|Evolocumab|Evolocumab is a fully human monoclonal antibody that inhibits PCSK9.
15976858|NCT03060564|Procedure|tendon graft|JRF Orthopedics Tendon Graft
15976859|NCT03060564|Other|No intervention|No intervention
15976860|NCT03060551|Procedure|SVF injection|SVF is increasingly recognised as an easily accessible source of regenerative cells with therapeutic potential in ischaemic or autoimmune disease. We aimed to measure for the first time the safety, tolerability and potential efficacy of autologous SVF cells local injections in patients with systemic sclerosis
15976861|NCT03060538|Drug|BFKB8488A|Administered subcutaneously starting on Day 1 and according to dosing schedule.
15976862|NCT03060538|Other|Placebo|Administered subcutaneously starting on Day 1 and according to dosing schedule.
15976863|NCT03060525|Behavioral|Deaf Weight Wise 2.0|"Deaf Weight Wise 2.0 is a group or individual intervention lead by trained, American Sign Language fluent Deaf counselors, who utilize an existing evidence-based curriculum that emphasizes healthy eating, exercise, and lifestyle components. It is a behavior change intervention that uses motivational interviewing techniques to help participants identify/recognize their own unhealthy behaviors, help individuals build skills that will promote behavior change, and help group members to support each other to make behavior changes. The Curriculum includes group exercise activities (Do It!), experiential learning activities (Try It! such as learning how to read a nutrition label or modify a recipe to make it healthier), and group activities related to food preparation or sampling healthy foods (Taste It!). Self-monitoring using daily food diaries and weekly weigh-ins is also a key component. The intervention also includes a 6-month follow up and maintenance phase."
15976864|NCT03060512|Drug|Polyethylene Glycol 3350|"Polyethylene Glycol 3350, 17 grams of powder to be dissolved in 4 to 8 ounces of water, juice, soda, coffee or tea to be taken once a day.
~Bisacodyl 5mg, 1-3 tablets may be taken by subject who does not experience a bowel movement within 72 hours."
15976865|NCT03060512|Drug|Movantik|"Movantik 25 mg, 1 tablet taken once a day on an empty stomach at least 1 hour prior to the first meal of the day or 2 hours after the meal.
~Bisacodyl 5mg, 1-3 tablets may be taken by subject who does not experience a bowel movement within 72 hours."
15976866|NCT03060486|Device|HYBENX®|"The mixture was then introduced inside the root canal using the pre-dosed syringe for 20 seconds with a sterile paper point with and up and down movement.
~Finally, the canal was rinsed with sterile saline water using a syringe with a side-vented 30 G needle."
15976867|NCT03060473|Drug|Azithromycin|Azithromycin 1 gm PO once
15976868|NCT03060473|Drug|Erythromycin|Erythromycin 250 mg IV every 6 hours for 48 hours followed by 500 mg PO every 8 hours for 5 days.
15976869|NCT03060473|Drug|Ampicillin|Ampicillin 2 gm IV every 6 hours for 2 days
15976870|NCT03060473|Drug|Amoxicillin|Amoxicillin 500 mg PO every 8 hours for 5 days (Azithromycin ARM) Amoxicillin 250 mg PO every 8 hours for 5 days (Erythromycin ARM)
15976871|NCT03060460|Diagnostic Test|Ultrasound guided sheath insertion|ultrasound is used routinely for sheath insertion
15976872|NCT03060447|Drug|Vesatolimod|Tablets Administered orally
15976873|NCT03060447|Drug|Placebo|Tablets Administered orally
15976874|NCT03060447|Drug|ART|ART regimens administered in accordance with their prescribing information. The following agents are allowed as part of the ART regimen: nucleoside reverse transcriptase inhibitors, raltegravir, dolutegravir (DTG), rilpivirine, and maraviroc.
15976875|NCT03060434|Drug|Pentoxifylline Oral Tablet|patient will receive for 15 days: Ibuprofen 600 mg bid; pregabalin 75 mg bid; paracetamol 1 g tid; pentoxifylline 400 mg bid
15976876|NCT03060434|Drug|Ibuprofen|patient will receive for 15 days: Ibuprofen 600 mg bid; pregabalin 75 mg bid; paracetamol 1 g tid
15976877|NCT03060421|Device|Aquamid reconstruction|Aquamid Reconstruction is a Polyacrylamide hydrogel that contains 2.5% polyacrylamide and 97.5% non-pyrogenic water, with a unique molecular structure that allows the normal water exchange with the surrounding tissue without losing shape. Aquamid Reconstruction is biocompatible, non-absorbable non-biodegradable, stable, and sterile. T Aquamid Reconstruction is injected into the knee joint cavity.
15976878|NCT03060395|Dietary Supplement|A2 milk 100|Days 1 and 2: 100 mL A2 milk twice a day
15976879|NCT03060395|Dietary Supplement|A2 milk 150|Days 3 and 4: 150 mL A2 milk twice a day
15976880|NCT03060395|Dietary Supplement|A2 milk 200|Days 5 and 6: 200 mL A2 milk twice a day
15976881|NCT03060395|Dietary Supplement|A2 milk 250|Days 7 to 14: 250 mL A2 milk twice a day
15976882|NCT03060395|Dietary Supplement|A1/A2 milk 100|Days 1 and 2: 100 mL A1/A2 milk twice a day
15976883|NCT03060395|Dietary Supplement|A1/A2 milk 150|Days 3 and 4: 150 mL A1/A2 milk twice a day
15976884|NCT03060395|Dietary Supplement|A1/A2 milk 200|Days 5 and 6: 200 mL A1/A2 milk twice a day
15976885|NCT03060395|Dietary Supplement|A1/A2 milk 250|Days 7 to14: 250 mL A1/A2 milk twice a day
15976886|NCT03060382|Device|balanced buttress absorbable spacer|For the patients of study group, a balanced buttress absorbable spacer was placed into the gap after the osteotomy of tibia and fibula to modify the lower limb line.
15976887|NCT03060382|Biological|total knee arthroplasty|Total knee arthroplasty was conducted for the patients of control group
15976888|NCT03060369|Device|CareGuide™ device|CareGuide™ is a minimal risk, non-invasive device that uses near-infrared spectroscopy to measure skeletal muscle oxygen saturation.
15976889|NCT03060356|Biological|T cells modified with RNA anti -cMET CAR|Intravenously administered, RNA electroporated autologous T cells expressing MET chimeric antigen receptors with tandem TCRζ and 4-1BB (TCRζ /4-1BB) co-stimulatory domains
15976890|NCT03060343|Biological|Zeushield Cytotoxic T Lymphocytes|"Three dose levels will be evaluated. Dose Level One: 1.0×10^5 cells/kg, Dose Level Two: 1.0×10^6 cells/kg, Dose Level Three: 1.0×10^7 cells/kg.
~At the discretion of the investigator, if patients with active disease have stable disease or a response at week 8 or on subsequent evaluations, they are eligible to receive up to 6 additional infusions at 8 to 12 week intervals."
15976891|NCT03060330|Procedure|Modified Laparoscopic Ventral Mesh Rectopexy|This group will undergo modified laparoscopic ventral mesh rectopexy alone
15976892|NCT03060330|Procedure|Modified Laparoscopic Ventral Mesh Rectopexy Combined with Stapled Trans-anal Rectal Resection|This group will undergo modified laparoscopic ventral mesh rectopexy combined with modified stapled trans-anal rectal resection
15976893|NCT03060317|Behavioral|Examination with neurological scales.|Coma Recovery Scale, Glasgo Coma Scale, FOUR scale
15976894|NCT03060304|Drug|Tamoxifen|Patients in study group will receive tamoxifen at a daily dose of 40 mg from day 3 to day 8.
15976895|NCT03060304|Drug|estradiol valerate|Patients in control group will receive estradiol valerate at a dose of 3 mg twice per day from day 3.
15976896|NCT03060291|Behavioral|FCU-Online, web/ mobile only|Participants will be invited to complete the FCU via the FCU-Online website. They will complete an assessment, receive computer-generated feedback, and access to skills units designed to teach parents the importance of using specific parenting skills, provide practice opportunities to try these skills, and tools to track their use of these parenting skills and any associated changes in child behavior.
15976897|NCT03060291|Behavioral|FCU-Online, web/ mobile + coach|"Participants will be invited to complete the FCU via the FCU-Online website. They will complete an assessment, receive computer-generated feedback, and access to skills units designed to teach parents the importance of using specific parenting skills, provide practice opportunities to try these skills, and tools to track their use of these parenting skills and any associated changes in child behavior. Participants will also have access to a family coach who will motivate parents to enhance parenting skills and provide support while they are learning to use these skills."
15976898|NCT03060278|Behavioral|Self-help materials|Self-help smoking cessation materials.
15976899|NCT03060278|Drug|nicotine patch|Participants who smoke >10 cigarettes per day will receive 4 weeks of 21 mg, 2 weeks of 14 mg and 2 weeks of 7 mg nicotine patches. Participants who smoke < 10 cigarettes per day will receive 6 weeks of 14 mg and 2 weeks of 7 mg nicotine patches.
15976900|NCT03060278|Other|Smartphone-delivered automated treatment|Tailored video clips, text and graphical messages delivered automatically each week to the participant.
15976901|NCT03060278|Behavioral|Counseling|Proactive phone counseling with a Certified Tobacco Treatment Counselor
15976902|NCT03060265|Drug|Paracetamol|Administrating Paracetamol IV pre-cesarean section
15976903|NCT03060265|Drug|PLACEBO|Administrating SALINE IV pre-cesarean section
15976904|NCT03060239|Other|Near Infrared Spectroscopy|Use of the near-infrared-spectroscopy (NIRS) to explore the cortical mechanism by which this sleep disorder would allow a disappearance of parkinsonian signs at night
15976905|NCT03060226|Diagnostic Test|blood sample|Search of blood predictive marker (s)
15976934|NCT03060018|Device|Sentec (SenTec) Digital Monitoring System with OxiVenT Sensor|The sensor will be attached to four anatomical positions (thoracic left and right; abdominal left and right), starting with the left thoracic position followed by 4-hourly clockwise position rotation. In case of severe oedema, the ear lobes will be used as anatomical measurement sites and changes to the contralateral ear lobe are made every 4 hours.
15976935|NCT03060005|Drug|Tears Naturale Forte|This medication is used to relieve dry, irritated eyes
15976906|NCT03060213|Behavioral|Fun For Wellness (FFW)|FFW consists of videos, games, and content teaching 14 skills to support seven drivers of change that promote well-being in I COPPE domains. The drivers form the acronym BET I CAN, which stands for: Behaviors, Emotions, Thoughts, Interactions, Context, Awareness, and Next Steps. B teaches basics of habit formation, including antecedents, behaviors, and consequences and techniques like goal setting, behavior tracking and rewards. E teaches how to build positive emotions and cope with negative ones. T teaches lessons from cognitive behavioral therapy. I builds communication skills such as empathy, listening and assertiveness. C teaches how to create healthier environmental contexts. A aims to increase insight. N emphasizes the need to make plans and anticipate barriers.
15976907|NCT03060200|Other|Self-administered online CBT plus therapist check in|The app being tested is comprised of courses, exercises and a behavioural activation component. Courses represent the psycho-educational background of the program, comprising topics such as: information on depression, what is CBT, healthy/unhealthy negative emotions, rational/irrational thoughts, behaviour, social support, relaxation techniques, sleep hygiene, relapse prevention, treatment adherence, and suicide prevention plan. Exercises use the information presented in the courses and follow the structure of a regular therapy session/ therapeutic homework. The following exercises are included in the app: Emotional Pulse, Find Irrational Thoughts, and Change Irrational Thoughts. The behavioural activation component consists in two main exercises: My goals and My Activities.
15976908|NCT03060200|Other|Sham self-administered online CBT plus therapist check in|The active placebo intervention will be delivered via the same platform and largely in the same format as the tested app: it will include the same sections and features as the original app, except for the complete exercises. In addition, the psychoeducation section, although mirroring the structure of the corresponding section in the original app, will include different content, elaborating on common sense psychological well being aspects.
15976909|NCT03060187|Other|KU Score|Exam with a max score of 10 and min score of 0. Designed as a preoperative assessment of the patient's airway.
15976911|NCT03060161|Behavioral|Health in the right measure|Nutritional monitoring and individual guidance on regular physical exercise.
15976912|NCT03060148|Device|Medtronic neurostimulation system|Dual leads for spinal cord stimulation will be performed at 90% of the motor threshold for 24 hours/day at 50 Hz and pulse width 0.2 ms
15976913|NCT03060135|Behavioral|Check Your Drinking|A anonymous brief survey designed to provide normative feedback of individual's drinking with the intent of motivating reductions in drinking
15976914|NCT03060135|Behavioral|Hello Sunday Morning|Brief online intervention that allows Individual's reflect on their drinking reductions progress and goals.
15976915|NCT03060122|Device|NIN|The InterX device will be applied by a trained therapist along the course of the dermatomes in the affected area, paying special attention to the location of major cutaneous nerves ensuring optimal treatment points are identified and treated within the neurologically related area.
15976916|NCT03060122|Device|Sham CES|The sham CES is identical to the regular device but ear clips will emit a dose at 100 mA, a sub-sensory level.
15976917|NCT03060122|Device|CES|Cranial Electrical Stimulation (CES) Alpha-Stim is a noninvasive medical treatment device that delivers a microcurrent (100 to 500 microamperes) via ear clip electrodes connected to a handheld device.
15976918|NCT03060109|Other|Blood draw within 12 hours of injury|
15976919|NCT03060096|Other|Severe Anxiety/depression: High Intensity Stepped Care|The stepped-care Telehealth high intensity intervention is tailored to participants with severe anxiety and depression. Ppts randomized to this group will have 12 weekly psychotherapy sessions delivered by phone with a licensed therapist. Participants will also receive a CBT (cognitive behavioral therapy) workbook including daily exercises to supplement understanding.
15976920|NCT03060096|Other|Moderate Anxiety/depression: Low Intensity Stepped care|The stepped care Telehealth low intensity intervention is tailored to participants with moderate anxiety and depression. Ppts randomized to this group will receive a self-guided CBT workbook and biweekly (every 2 weeks) check-in calls from a research staff person to assess changes in symptom severity and need for treatment/support.
15976921|NCT03060096|Other|Enhanced Usual Care Control|"Participants with moderate to severe anxiety/depression that are randomized to Enhanced Usual Care Control (EUC) will receive information about referrals/resources in their local area (support groups, mental health providers), NCI materials (Facing Forward: Life after Cancer Treatment, self-help workbooks, copy of the CBT (cognitive behavioral therapy) workbook on completion of the study."
15976922|NCT03060083|Other|Very low nicotine content (VLNC) cigarettes and nicotine replacement therapy (NRT)|Participants will switch to very low nicotine content (VLNC) cigarettes with the aid of nicotine replacement therapy (NRT)
15976923|NCT03060083|Other|Reduce cigarettes per day (CPD) with nicotine replacement therapy (NRT)|Participants will reduce cigarettes per day (CPD) with the aid of nicotine replacement therapy (NRT)
15976924|NCT03060070|Drug|Ketamine|Ketamine at a dose of 0.5mg/kg will be added to bupivacaine 0.25 (total volume 20ml) in each side using sonar guided TAP block
15976925|NCT03060070|Drug|dexmedetomidine|dexmedetomidine at a dose of 1ug/kg will be added to bupivacaine 0.25 (total volume 20ml) in each side using sonar guided TAP block
15976926|NCT03060070|Drug|control group|20ml of 0.25% bupivacaine will be injected in each side of the TAP block
15976928|NCT03060044|Drug|Salmeterol/fluticasone Easyhaler|
15976929|NCT03060044|Drug|Salmeterol/fluticasone Easyhaler with charcoal|
15976930|NCT03060044|Drug|Seretide Diskus|
15976931|NCT03060044|Drug|Seretide Diskus with charcoal|
15976932|NCT03060031|Drug|Oxytocin|Oxytocin intranasal administration, 40 IU, 5 puffs per nostril at 4 IU per puff delivered approximately 45 minutes prior to pain tasks.
15976933|NCT03060031|Drug|Placebo|Placebo intranasal administration, 5 puffs per nostril delivered approximately 45 minutes prior to pain tasks
15976936|NCT03060005|Drug|liposic|Liposic eye gel contain the active ingredient carbomer, which is a type of medicine known as an eye lubricant. It is used for the treatment of the symptoms of dry eye.
15976937|NCT03059992|Drug|Ibrexafungerp|Experimental Study Drug
15977404|NCT03056573|Device|Subclavian /Axillary TAVR implant|Subclavian /Axillary TAVR implant
15976938|NCT03059979|Drug|Methylprednisolone|methylprednisolone 1000 mg dissolved in 100 cc of NaCl 0.9%, by intravenous infusion in 30 minutes on three consecutive days Three-day treatment courses are given at week 0, week 4 and week 8.
15976939|NCT03059979|Other|sodium chloride|100 cc of NaCl 0,9% , administered by intravenous infusion in 30 minutes on three consecutive days Three-day treatment courses are given at week 0, week 4 and week 8.
15976940|NCT03059966|Procedure|Microsurgery technique for root coverage|Microsurgery technique for root coverage adapted for macrosurgery
15976941|NCT03059966|Biological|Microsurgery technique for root coverage associated to EMD|Microsurgery technique for root coverage adapted for macrosurgery associated to Enamel Matrix Derivative
15976942|NCT03059940|Behavioral|Questionnaires|Questionnaires completed at baseline and at 6 weeks, 12 weeks, and 6 months after the CT scan.
15976943|NCT03059940|Procedure|Low Dose Computed Tomography Scan|Participants have a CT scan of chest to look for signs of lung cancer.
15976944|NCT03059940|Other|Shared Decision Making + Video|Participants given shared decision making and discussion about screening with the LDCT provider. Participants watch a short video about lung cancer, CT scans, and smoking cessation.
15976945|NCT03059940|Behavioral|Cessation Counseling|Brief cessation counseling given by LDCT provider.
15976946|NCT03059940|Behavioral|Quitline|Participants referred to the Quitline for counseling. Participants have 5 smoking cessation counseling sessions over the next 12 weeks.
15976947|NCT03059940|Behavioral|Pharmacotherapy Discussion|Participant informed of the risk, benefits and relative efficacy of cessation medications and to assess their medication preferences, expectations and medical suitability for either option. At the conclusion of this conversation the patient is provided with an initial supply of the medication jointly decided between provider and patient.
15976948|NCT03059940|Drug|Nicotine Patch|Nicotine patch dispensed. Dosing at physician's discretion.
15976949|NCT03059940|Drug|Anti-Smoking Drug|Varenicline or Buproprion prescribed by study doctor with directions of when and how much of anti-smoking drug that should be taken each time.
15976950|NCT03059940|Behavioral|Tobacco Treatment Program|Participant referred to Tobacco Treatment Program (TTP). TTP provides 4-8 counseling sessions and pharmacotherapy over a 10-12 week period,
15976951|NCT03059940|Other|Carbon Monoxide (CO) Level Test|Participant asked to blow air through a CO-measuring device.
15976952|NCT03059927|Procedure|Knee arthroplasty, Cruciate retaining|Legion total knee arthroplasty implant component, Smith & Nephew, Cruciate Retaining design
15976953|NCT03059927|Procedure|Knee arthroplasty, Anterior stabilized|Legion total knee arthroplasty implant component, Smith & Nephew, Anterior Stabilized design
15976954|NCT03059927|Procedure|Knee arthroplasty, Posterior stabilized|Legion total knee arthroplasty implant component, Smith & Nephew, Posterior Stabilized design
15976955|NCT03059914|Device|InterOss|Anorganic bovine bone mineral - Xenograft
15976956|NCT03059914|Device|Bio-oss|Anorganic bovine bone mineral ( Xenograft)
15976957|NCT03059901|Other|Caminamos App|Mobile phone that encourages Latina women to walk together through social support.
15976958|NCT03059888|Drug|Abatacept Injection|Subcutaneous administration of abatacept
15976959|NCT03059875|Behavioral|Medical consultation for a Standardized Geriatric Evaluation|
15976960|NCT03059862|Dietary Supplement|L-tryptophan|3 g/day of L-tryptophan added to the standardized low-tryptophan diet. Duration: 3 weeks.
15976961|NCT03059862|Dietary Supplement|Placebo|A placebo will be added to the standardized low-tryptophan diet. Duration: 3 weeks.
15976962|NCT03059849|Drug|Adalimumab|Dose of adalimumab will be increased by 40mg every 2 weeks.
15976963|NCT03059836|Dietary Supplement|n3 PUFA-enriched fish oil|3000mg of Eicosapentaenoic acid per day and 1800mg of Docosahexaenoic acid per day
15976964|NCT03059836|Dietary Supplement|Placebo|Organic Sunflower Oil 5000mg per day
15976965|NCT03059823|Drug|retifanlimab|Anti-PD-1 monoclonal antibody
15976966|NCT03059810|Device|etafilcon A|Investigational Contact Lens
15976967|NCT03059797|Drug|Anlotinib|Anlotinib Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle
15976968|NCT03059797|Drug|Placebo|Placebo Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle
15976969|NCT03059784|Other|APP-based multifaceted management|Patients after PCI will be regularly given education materials, medication reminders, life-style behaviors instruction through APP. Cardiologists can interact with patients on advice provision and clinical support after discharge through APP.
15976970|NCT03059771|Behavioral|Mobile Enhancement of Motivation (MEMS)|The MEMS group will engage in a goal-setting session and then receive personalized text-messages to support goal attainment.
15976971|NCT03059771|Behavioral|Control|The control group will only engage in a goal-setting session.
15976972|NCT03059758|Other|fMRI|All participants are scanned while evaluating deductive reasoning problems. Their math skill is also assessed.
15976973|NCT03059745|Procedure|Cholecystectomy|Single Port and Multi-Port approaches trans-laparoscopic approaches with or without the use of the daVinci Surgical Robotic System.
15976974|NCT03059732|Other|Treatment|Observe the treatments of gastric cancer in each group
15976975|NCT03059719|Biological|Exenatide injection(Byetta)|
15976976|NCT03059719|Biological|PB-119 injection|
15976977|NCT03059706|Device|RegenoGel-OSP™|intra-articular injection of RegenoGel-OSP™ after arthroscopic surgery
15976978|NCT03059706|Other|saline|intra-articular injection of saline after arthroscopic surgery
15976979|NCT03059693|Drug|HAT1 topical cream|
15976980|NCT03059693|Drug|Vehicle cream|
15976981|NCT03059680|Other|High potassium diet|An increase in consumption of high potassium fruits and vegetables
15976982|NCT03059667|Drug|Atezolizumab|Atezolizumab at 1200 mg IV every 3 weeks
15976983|NCT03059667|Drug|Topotecan|oral 2.3 mg/m² or IV 1.5 mg/m² day 1-4 recommended
15976984|NCT03059667|Drug|Carboplatin|In accordance with the summary of product characteristics.
15976985|NCT03059667|Drug|Etoposide|In accordance with the summary of product characteristics.
15976986|NCT03059654|Procedure|tracheostomy|
15977045|NCT03059147|Drug|SF1126|SF1126 is a dual PI3 kinase/BRD4 inhibitor small molecule. It will be administered IV twice weekly (900 mg/m2 starting dose with escalation to 1000 mg/m2 per dose and 1100 mg/m2 per dose) at a dose determined by the cohort the patient is enrolled in until progression or unacceptable toxicity develops.
15976987|NCT03059628|Other|Personalized Normative Feedback|"This PNF technique use information designed to correct normative misperceptions to reduce heavy drinking. Much of the alcohol consumption among college students stems from the fairly widespread perception that one's peers expect regular and sometimes extreme drinking participation (subjective drinking norms). The PNF approach is designed to counter this perception by giving students accurate figures on how much their peers actually drink (actual drinking norms). It also aims to improve students' understanding of alcohol use in general and the firmly established negative outcomes associated with short - and long-term patterns of excessive drinking."
15976988|NCT03059628|Other|Brief Therapeutic Intervention|BTI are brief (typically one session 20-30 mns) and incorporate some or all of the following elements:feedback on the person's alcohol use and any alcohol-related harm; clarification as to what constitutes low risk alcohol consumption; information on the harms associated with risky alcohol use; benefits of reducing intake; motivational enhancement; analysis of high risk situations for drinking and coping strategies; and the development of a personal plan to reduce consumption.
15976989|NCT03059628|Other|Evaluation questionnaire|The patient have to fill the same evaluation questionnaire at J0, M6 and M12
15976990|NCT03059615|Drug|Nerofe|Nerofe is a first-in-class hormone-peptide with cancer suppressive properties. Nerofe is a derivative of the human hormone-peptide Tumor-Cells Apoptosis Factor (TCApF). It contains 14 amino-acids. Binding Nerofe to the T1/ST2 receptor caused a rapid activation both of Caspase 8 and Bcl-2 mediated downstream in proliferating cancer cells.
15976991|NCT03059615|Drug|Doxorubicin|Doxorubicin is an anthracycline antibiotic with antineoplastic activity. Doxorubicin, isolated from the bacterium Streptomyces peucetius var. caesius, is the hydroxylated congener of daunorubicin. Doxorubicin intercalates between base pairs in the DNA helix, thereby preventing DNA replication and ultimately inhibiting protein synthesis.
15976992|NCT03059602|Other|No specific treatment based intervention-health measurement instrument|Caregivers will receive a series of standard health measurement tools/survey from NIH's Patient Reported Outcome Measurement Information System (PROMIS)
15976993|NCT03059576|Other|Chronobiological status of the subjects|"Participation was completely voluntary and not remunerated. The subjects were organized into groups of 5 pairs, and were given an appointment at a university facility located in the city center, where informed consent was signed prior to the procedures indicated below. An informational letter was sent to pre-selected individuals. Later a phone call confirmed their availability.
~Temperature rhythm was assessed continuously for 7 days using a temperature sensor and programmed to collect information every 10 min.
~Body position and rest-activity rhythm were assessed over the same 7 days using a Acceleration Data Logger that record data every min and placed on the non-dominant arm by means of an elastic band, with its X axis parallel to the humerus bone.
~Diet and sleep record were completed over the same week, their sleep schedules and their nutritional status."
15976994|NCT03059563|Drug|Varenicline|Varenicline is an FDA-approved medication to facilitate smoking cessation. it is also a promising candidate to enhance dopamine signaling by upregulating dopamine D2/D3 (type 2) receptors in the striatum and improve cognitive function.
15976995|NCT03059563|Other|Placebo|A placebo containing no active ingredients will be used as a control to assess the effects of varenicline on dopamine D2/D3 receptor availability and cognitive function.
15976996|NCT03059537|Drug|Oral chenodeoxycholic acid stimulation|oral intake of chenodeoxycholic acid to stimulate the ileal bile acid transporter and farnesoid X receptor
15976997|NCT03059511|Drug|Nalbuphine|Opioid Pain Medicine
15976998|NCT03059498|Procedure|Unilateral PECS I and II block|A truncal block called the pectoralis nerve block (PECS I and II block). Unilateral. Using Bupivacaine
15976999|NCT03059498|Procedure|Bilateral PECS I and II block|A truncal block called the pectoralis nerve block (PECS I and II block). Bilateral. Using Bupivacaine.
15977000|NCT03059498|Drug|Bupivacaine|Bupivacaine solution 0.25%. At the PECS I site each patient will receive 10 cc of local anesthetic solution, and at the PECS II site an additional 20 cc of local anesthetic solution will be placed.
15977001|NCT03059485|Biological|DC/AML Fusion Vaccine|The Dendritic Cell Fusion Vaccine is an investigational agent that tries to help the immune system to recognize and fight against cancer cells
15977002|NCT03059485|Other|Observation|Traditional care provided by the hospital.
15977003|NCT03059472|Behavioral|Group 1 (Intervention)|"The investigators will evaluate the efficacy of the SHHC curriculum in a 24-week community-based randomized delayed intervention trial. They will compare changes in CVD-related anthropometric, physiologic, behavioral, and psychosocial parameters between subjects in 5 intervention and 6 delayed intervention communities. In addition, the investigators will evaluate changes in behavior, attitudes, and knowledge among SHHC intervention subjects' social network."
15977004|NCT03059472|Behavioral|Group 2 (Delayed intervention)|"The investigators will evaluate the efficacy of the SHHC curriculum in a 24-week community-based randomized delayed intervention trial. They will compare changes in CVD-related anthropometric, physiologic, behavioral, and psychosocial parameters between subjects in 5 intervention and 6 delayed intervention communities. In addition, the investigators will evaluate changes in behavior, attitudes, and knowledge among SHHC intervention subjects' social network."
15977005|NCT03059446|Drug|Cenicriviroc|Cenicriviroc 150 mg tablet once daily in the morning with food.
15977006|NCT03059433|Other|AVID Intervention|Advancement via Individual Determination (AVID) is a college preparatory program that participating high schools have available to students.
15977007|NCT03059407|Behavioral|Dog therapy only|Canine assisted therapy only during echocardiogram
15977008|NCT03059407|Behavioral|Dog plus standard distraction tech|Canine assisted therapy plus standard distraction techniques during echo
15977009|NCT03059407|Behavioral|Standard distraction techniques only|Standard distraction techniques (such as watching a movie) only during echocardiogram
15977010|NCT03059394|Device|Non intervention study|Test - Retest of measurements
15977011|NCT03059381|Drug|Fycompa|The usual oral dosage for adults and children 12 years of age or older is initially 2 milligrams (mg) once daily as perampanel at bedtime, and the daily dose may then be increased by 2 mg at intervals of 1 week or longer. The maintenance dose is 8 mg once daily in the absence of concomitant antiepileptic drugs that accelerate the metabolism of this product, or 8 to 12 mg once daily in the presence of such concomitant drugs. The dosage may be increased or decreased as necessary by 2 mg at intervals of 1 week or longer depending on symptoms, but the maximum daily dose should not be over 12 mg.
15977517|NCT03055754|Procedure|Control arm|No Endoscopic procedure
15977012|NCT03059368|Device|new bone fixation plate with screw|Fracture ends and injured posterior cruciate ligament will be exposed in twenty patients with tibial avulsion fracture of posterior cruciate ligament of knee through posterior approach. Open reduction will be conducted. The posterior cruciate ligament will be reconstructed with a new bone fixation plate with screw(cancellous bone screw).
15977013|NCT03059355|Biological|UCMSCs|Allogeneic Umbilical Cord Tissue derived MSCs (UCMSCs)
15977014|NCT03059355|Biological|BMMSCs|Bone Marrow derived Mesenchymal Stem Cells (BMMSCs)
15977015|NCT03059355|Other|Placebo|a single administration of placebo delivered via peripheral intravenous infusion.
15977016|NCT03059342|Procedure|single event multilevel surgery|
15977017|NCT03059329|Drug|Fycompa|The usual oral dosage for adults and children 12 years of age or older is initially 2 milligrams (mg) once daily as perampanel at bedtime, and the daily dose may then be increased by 2 mg at intervals of 1 week or longer. The maintenance dose is 8 mg once daily in the absence of concomitant antiepileptic drugs that accelerate the metabolism of this product, or 8 to 12 mg once daily in the presence of such concomitant drugs. The dosage may be increased or decreased as necessary by 2 mg at intervals of 1 week or longer depending on symptoms, but the maximum daily dose should not be over 12 mg.
15977018|NCT03059316|Combination Product|Massimo device|Massimo is a newly introduced device which can measure the peripheral organ perfusion and expressed it as perfusion index(PI).
15977019|NCT03059316|Drug|Nitroglycerin drug|Nitroglycerin is a drug used as an hypotensive agent through its vasodilation effect on veins
15977020|NCT03059316|Drug|Labetalol|Labetalol is an antagonist of adrenergic receptors (a1, b1, b2) which is used as an hypotensive inducer. This drug targets the beta receptors 5 to 10 times more specific than alpha receptors so that minor tachycardia happens
15977021|NCT03059303|Drug|Simeprevir 75 mg|"Part 1: Simeprevir (SMV) 75 mg taken orally as a component of FDC tablet in Treatment A, B, D and E and as a single agent capsule in Treatment C.
~Part 2: SMV 75 mg taken orally as a component of FDC tablet in Treatment A2, F (2 tablets of 37.5 mg each), and G (2 tablets of 37.5 mg each), and as a single agent capsule in Treatment C2."
15977022|NCT03059303|Drug|Odalasvir 25 mg|"Part 1: Odalasvir (ODV) 25 mg taken orally as a component of FDC tablet in Treatment A, D and E and as a single agent tablet in Treatment C.
~Part 2: ODV 25 mg taken orally as a component of FDC tablet in Treatment A2 and F (2-tablets of 12.5 mg each), and as a single agent tablet in Treatment C2."
15977023|NCT03059303|Drug|Odalasvir 12.5 mg|Part 1: ODV 12.5 mg taken orally as a component of FDC tablet in Treatment B.
15977024|NCT03059303|Drug|Odalasvir 75 mg|Part 2: ODV 75 mg taken orally as a component of FDC tablet (2 tablets of 37.5 mg each) in Treatment G.
15977025|NCT03059303|Drug|AL-335 800 mg|"Part 1: AL-335 800 mg taken orally as a component of FDC tablet in Treatment A, B, D and E and as a single agent tablet in Treatment C.
~Part 2: AL-335 800 mg taken orally as a component of FDC tablet in Treatment A2, F (2 tablets of 400 mg each), and G (2 tablets of 400 mg each) and as a single agent tablet in Treatment C2."
15977026|NCT03059303|Drug|Lansoprazole 30 mg|30 mg lansoprazole once daily from Day 1 to Day 5.
15977027|NCT03059303|Drug|Omeprazole 20 mg|20 mg omeprazole once daily from Day 1 to Day 5.
15977028|NCT03059290|Device|neolix file|first file used is C1 file size 25 taper 12% as orifice opener and for coronal flaring for 2/3 of canal length the A1 file size 25 taper 8% in narrow or curved canals if size 10 K file (Mani ,Japan ) is loose or pass easily in the canal , but in case of K-file size 20 loose in the canal so we choose large file size 40 taper 4% either of them to the full working length to the full working length with (X-Smart, Dentsply Maillefer, USA.), with speed 300-500 rpm and torque 1.5 N.cm
15977029|NCT03059277|Drug|Intravitreal Aflibercept|Intravitreal Aflibercept 2mg
15977030|NCT03059264|Other|Natural history|Longitudinal disease progression
15977031|NCT03059251|Biological|Obinutuzumab|Obinutuzumab will be administered as intravenous infusion for 6 cycles (28 days per cycle): 100 milligrams (mg) on day 1 Cycle 1, 900 mg on day 2 Cycle 1, 1000 mg on days 8 and 15 of Cycle 1, and 1000 mg on day 1 of Cycles 2-6.
15977032|NCT03059238|Drug|Celecoxib 200mg oral capsule|
15977033|NCT03059238|Drug|parecoxib sodium|
15977034|NCT03059238|Drug|controlled-release oxycodone|
15977035|NCT03059225|Device|repetitive transcranial magnetic stimulation (rTMS)|undergo contralesional 1Hz repetitive transcranial magnetic stimulation(rTMS) or high frequency ipsilesional rTMS for 10 daily sessions
15977036|NCT03059225|Device|Sham stimulation|2-week inhibitory non-dominate hemisphere rTMS program
15977037|NCT03059212|Device|rTMS|High frequency rTMS for 3 to 10 min to increase the excitability of cortex.
15977038|NCT03059212|Behavioral|Cognitive training program|A rehabilitation protocol that facilitates attention, memory, execution.
15977039|NCT03059199|Behavioral|Single-Arm Feasibility Study|Participants are provided with the HAT TRICK Playbook, a resource manual including weekly healthy eating and physical activity challenges and tracking logs. Each face-to-face session is facilitated by trained research staff, community partners, and health care professionals. Weekly sessions include information on physical activity, healthy eating, and behaviour change techniques (e.g., social support, goal setting, self-monitoring) and include an opportunity to be active/exercise.
15977040|NCT03059186|Behavioral|Gratitude diary|"The intervention involves keeping a record of three things that the individual feels grateful for during that day.
~This can be completed daily, and for the purpose of this study will be completed every evening for the duration of one week."
15977044|NCT03059160|Drug|Tridecanoic Acid|3 times daily oral doze of the drug for 20 weeks with 4 weeks of baseline and 4 weeks of washout
15977081|NCT03058939|Drug|FEC|Only administered to patients who received paclitaxel and carboplatin, and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable).
15977046|NCT03059147|Drug|Nivolumab|Nivolumab is a humanized, IgG4 isotype monoclonal antibody that binds to PD-1 and blocks binding of PD-1 to its ligands PD-L1 and PD-L2. It will be administered at 240 mg IV every 2 weeks until progression or unacceptable toxicity develops.
15977047|NCT03059134|Drug|Mirabegron 25mg|We compared the therapeutic effects and adverse events (AEs) in overactive bladder (OAB) patients receiving different combination of mirabegron and solifenacin.
15977048|NCT03059108|Procedure|Early Loading|The procedure in this group will consist on placing implant-supported restorations over the implants placed 4 weeks earlier. The device (dental implant) is of the same type in both groups.
15977049|NCT03059108|Procedure|Conventional Loading|The procedure in this group will consist on placing implant-supported restorations over the implants placed 8 weeks earlier. The device (dental implant) is of the same type in both groups.
15977050|NCT03059095|Behavioral|Yoga & Meditation|Yoga is an ancient Indian science and way of life that includes the practice of specific postures, regulated breathing, and meditation.mindfulness-based stress reduction, an intervention that teaches individuals to attend to the present moment in a nonjudgmental, accepting manner
15977051|NCT03059082|Behavioral|Recovery Navigator on an as needed basis up to 6 months|"This group will undergo contact with Recovery Navigator on an as needed basis up to 6 months and then have a 3 month and 6 month follow-up visit."
15977052|NCT03059082|Behavioral|Recovery Navigator prior to hospital discharge|This group will undergo one interaction with Recovery Navigator prior to hospital discharge and then have a 3 month and 6 month follow-up visit.
15977053|NCT03059082|Other|No interaction with Recovery Navigator|This group will not have any interaction with Recovery Navigator. They will have a 3 month and 6 month follow-up visit.
15977054|NCT03059069|Drug|Chonline Alphoscerate|Patients treated with Chonline Alphoscerate as add on therapy to their medication
15977055|NCT03059069|Drug|Placebo Oral Tablet|Patients maintain their medication with either Gliatamin or placebo for 6 months.
15977056|NCT03059056|Drug|Empagliflozin 25mg|Samples from six, healthy, adult, male, smoking, Egyptian volunteers (age: 22-33 years, Average weight: 77.8 kg, Average BMI: 29.2) will be collected at 0, 0.5, 1, 1.5, 2, 3, 4, 8 and 12 h after administration of Empagliflozin 25 mg
15977057|NCT03059043|Device|viscoelastic-free implantation system|Viscoelastic-free implantation system use balanced salt solution irrigation during the implantation
15977058|NCT03059043|Device|standard viscoelastic-assisted Implantation system|This method utilize the viscoelastic agent to fill and maintain the anterior chamber during the implantation
15977059|NCT03059030|Device|TheraSphere® Yttrium-90 Glass Microspheres, BTG International Inc.|The Interventional Radiologists will inject a dose of Yttrium 90 into your spleen through a small catheter placed in your femoral artery.The entire treatment visit is an outpatient procedure. You will only be admitted to the hospital if the physician deems it necessary due to any symptoms you may experience after the treatment is given. This visit may take 6 to 8 hours.
15977060|NCT03059017|Drug|Salbutamol Sulphate|salbutamol sulphate packaged as aerosol
15977061|NCT03059017|Drug|Niosomes|Niosomes
15977062|NCT03059004|Behavioral|TeMPO Home Exercise Program|This exercise program includes quadriceps, gluteus medius, gluteus maximus, and core exercises. The program includes a DVD and multi-page instruction pamphlet.
15977063|NCT03059004|Behavioral|Motivational SMS Messages|The motivational SMS messages will be sent three times per week encouraging participants to complete their exercises.
15977064|NCT03059004|Behavioral|In-Clinic Topical Therapy|Subjects will be assigned to a physical therapist and will attend 14 in-clinic topical therapy sessions. Sessions will include application of ultrasound, gel, and manual therapy.
15977065|NCT03059004|Behavioral|In-Clinic Exercise Therapy|Subjects will be assigned to a physical therapist and will attend 14 in-clinic exercise and manual therapy sessions. Sessions will include the same exercises from the Home Exercise Program but the in-clinic therapy setting will allow for more personalization.
15977066|NCT03058991|Behavioral|Distress Tolerance Intervention|See arm/group description.
15977067|NCT03058991|Behavioral|Working Memory Intervention|See arm/group description.
15977068|NCT03058991|Behavioral|Control Informational Intervention|See arm/group description.
15977069|NCT03058978|Device|Etonogestrel Implant|Ovarian function will be assessed with weekly serum progesterone levels. Participants will undergo weekly venipuncture for a total of four draws over a 30 day period. Participants will also complete a bleeding diary to assess daily bleeding patterns for the 30 day study period.
15977070|NCT03058965|Drug|[18F]MNI-958|Subjects will undergo PET imaging using [18F]MNI-958, a PET radioligand for imaging tau.
15977071|NCT03058965|Drug|[18F]Florbetapir|Subjects with Alzheimer's disease will receive a [18F]florbetapir scan to compare distribution of tau in the brain compared to that of [18F]MNI-958.
15977072|NCT03058965|Drug|DaTscan|DaTscan SPECT imaging will be completed in those PSP subjects who have not previously had DATScan imaging as part of the screening procedures.
15977073|NCT03058952|Behavioral|Mindfulness-Based Stress Reduction|An 8-week standardized group program to teach mindfulness skills. In MBSR, participants meet for 2.5 hours per week for 8 weeks in a group format. Participants receive instruction in mindfulness meditation according to a standardized curriculum and have the opportunity to ask questions.
15977074|NCT03058952|Behavioral|Chronic Disease Self-Management Program|The CDSMP is a structured program to teach self-management skills based on self-efficacy theory. CDSMP teaches self-management strategies and attempts to modify illness beliefs, enhance self-management capabilities and reinforce successful management strategies. CDSMP is based on self-efficacy theory, which posits that key determinants of behavior are: 1). self-efficacy (confidence in the ability to carry out an action) and 2). outcome expectancy (expectation that a particular goal will be achieved).
15977075|NCT03058939|Drug|Paclitaxel|Administered to all patients for a minimum of 8 doses with a possible maximum of 16 doses.
15977076|NCT03058939|Drug|Perjeta|Only administered to patients with HER2-positive disease.
15977077|NCT03058939|Drug|Herceptin SC|Only administered to patients with HER2-positive disease.
15977078|NCT03058939|Drug|Tamoxifen|Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole.
15977079|NCT03058939|Drug|Letrozole|Only administered to hormone-receptor positive patients. Patients will receive tamoxifen or letrozole.
15977080|NCT03058939|Drug|LHRH agonist|Administered to all premenopausal patients.
15977082|NCT03058939|Drug|Carboplatin|Only administered to patients who receive paclitaxel and were assessed as having poor response (defined as stable disease or progressive disease or partial response inoperable).
15977083|NCT03058926|Other|Data Management and Monitoring|"Clinical Research Support Center's Data Management and Multicenter Study Support (MCSS) teams responsible for monitoring protocol and regulatory compliance for all consortium studies.
~MCSS responsible for maintaining and tracking IRB approval and regulatory documents from each site throughout the life of the study."
15977084|NCT03058900|Drug|Fecal microbiota transplantation (FMT)|One fecal microbiota transplantation is performed at baseline using gastroscopic guidance. The transplant consists of 50 g feces obtained from a healthy non-related donor. The donor feces is suspended into NaCl (0.9%) and glycerol (10%), and will be stored at minus 80 degrees celsius until use. The total volume of the suspension is 250 mL and its temperature will be 37 degrees celsius when infused into the small intestine of the recipient.
15977085|NCT03058900|Other|Drug: Placebo (saline)|One identical appearing sham procedure is performed at baseline using gastroscopic guidance. 250 mL saline (NaCl 0.9%) is infused into the small intestine of the recipient.
15977086|NCT03058900|Drug|Methotrexate (MTX)|Weekly methotrexate in maximum tolerable dosis
15977087|NCT03058887|Other|Exercise intervention - Cycling|The patients that will be randomly allocated to the exercise group - cycling will be requested to perform an exercise session on a cycle ergometer. Each training will be consisted of high intensity interval training for 30 minutes (30s 100% PPO/ 30s passive recovery) twice per week for 3 months. Patients will perform two visits for the baseline measurements prior the exercise intervention by repeating them at the end of the exercise intervention (follow up measurements).
15977088|NCT03058887|Other|Exercise intervention - arm cranking|The patients that will be randomly allocated to the exercise group - arm cranking will be requested to perform an exercise session on an arm crank ergometer. Each training will be consisted of high intensity interval training for 30 minutes (30s 100% PPO/ 30s passive recovery) twice per week for 3 months. Patients will perform two visits for the baseline measurements prior the exercise intervention by repeating them at the end of the exercise intervention (follow up measurements).
15977089|NCT03058874|Device|Extra-vascular lung water measurements by ultrasound|Lung congestion measured by lung ultrasound (US-B lines) to guide dry-weight probing and UF intensification
15977090|NCT03058874|Other|Standard protocol of fluid management in hemodialysis|The intervention consists in applying a standard clinical approach for monitoring/tailoring fluid excess in HD patients.
15977091|NCT03058861|Behavioral|Play Nicely Program|Play Nicely multimedia program and handbook that provides education about healthy discipline strategies.
15977092|NCT03058848|Dietary Supplement|PKU Start|"PKU Start is a powdered, phenylalanine-free, infant formula, containing essential and non-essential amino acids, carbohydrate, fat, vitamins, minerals, trace elements and long chain polyunsaturated fatty acids (LCPs); Arachidonic acid (AA) and Docosahexaenoic acid (DHA). It is suitable for use from birth.
~The recommended amount of the product for each participant will be determined and prescribed by a dietitian."
15977093|NCT03058835|Drug|tenofovir disoproxil and emtricitabine|Pre-exposure Prophylaxis with Truvada will be distributed to all participants eligible to receive PrEP.
15977094|NCT03058822|Drug|BMS-931699|BMS-931699 single subcutaneous dose on Day 1
15977095|NCT03058809|Device|Oncopheresis|Oncopheresis is a type of apheresis incorporating an extracorporeal blood circuit and a filter to separate circulating tumor cells from normal blood components.
15977096|NCT03058796|Device|Contralaterally Controlled Functional Electrical Stimulation (CCFES)|The use of surface electrodes over the paretic finger and thumb extensors to deliver electrical stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove. uses surface electrodes over the paretic finger and thumb extensors to deliver stimulation with an intensity that is proportional to the degree of opening of the contralateral unimpaired hand wearing an instrumented glove.
15977097|NCT03058796|Device|Hand Therapy Video Games|The use of video games with NMES to encourage therapeutic hand movement at home
15977098|NCT03058783|Drug|IDP-124 Lotion|Lotion
15977099|NCT03058783|Drug|IDP-124 Vehicle Lotion|Lotion
15977100|NCT03058770|Other|Sensorimotor retraining|Subjects will receive education regarding sensation and sensory retraining; practice in detection and localization of touch and in discrimination of hardness, texture and temperature in sitting and standing with vision obscured; proprioception training; and practice of these sensations in functional activities.
15977101|NCT03058770|Other|Relaxation technique|Subjects will perform guided relaxation by using the Jacobson technique.
15977102|NCT03058757|Drug|intravesical mitomycin-C 40mg/20ml instillation|"neoadjuvant Intravesical mitomycin-C 40mg/20ml instillation
~one day before surgery
~four hours before surgery"
15977103|NCT03058744|Drug|IDP-118 Lotion|Lotion
15977104|NCT03058744|Drug|HP Monad Lotion|Lotion
15977105|NCT03058744|Drug|Ultravate Cream|Cream
15977106|NCT03058744|Drug|Tazorac Cream|Cream
15977107|NCT03058731|Device|Matristem|Paraesophageal hernia repair with MatriStem Surgical Matrix
15977108|NCT03058731|Device|Control|Paraesophageal hernia repair with other biologic mesh
15977109|NCT03058718|Other|Procalcitonin|The application of antimicrobial agents is determined by PCT results.
15977110|NCT03058718|Other|Clinical Experience|The application of antimicrobial agents is determined by clinical experience of doctors.
15977111|NCT03058705|Drug|Hexaminolevulinate HCL|Intravesical instillation of 100 mg hexaminolevulinate HCL will be performed via foley catheter at the initiation of the procedure. Although NIRF is more sensitive than bluelight cystoscopy, the current FDA approved dose will be used. Hexaminolevulinate has a favorable safety profile at this dose.
15977112|NCT03058705|Device|Near Infrared Fluorescence (NIRF)|NIRF is a highly sensitive multi-spectral imaging modality that speeds the detection of bladder cancer fluorescence after infusion of hexaminolevinulate.
15977113|NCT03058692|Biological|Influenza Multimeric-001 Vaccine|The M-001 vaccine consists of 3 repetitions of 9 conserved linear epitopes that are prepared as a single recombinant protein. The M-001 vaccine is expected to protect against existing as well as future seasonal and pandemic virus strains.
15977114|NCT03058692|Other|Placebo|Placebo is saline injection
15977155|NCT03058419|Drug|Omeprazole 20 mg|Subjects will receive omeprazole 20 mg capsule (1*20 mg) orally as a drug cocktail on Day 1, 7 and 11.
15977115|NCT03058692|Biological|Quadrivalent Recombinant Seasonal Influenza Vaccine|Quadrivalent Inactivated Influenza Vaccine (IIV4) for intramuscular injection is indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B present in the vaccine.
15977116|NCT03058679|Other|Diet|food for the diet will be provided to the participants for 6 weeks and participants will follow the diet on their own for the remaining 6 weeks
15977117|NCT03058666|Drug|Aerosolized Calfactant|Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.
15977118|NCT03058666|Device|Solarys|Aerosolization of Infasurf at 6ml/kg via the modified Solarys aerosol generator.
15977119|NCT03058653|Procedure|Small fluid boluses of 50 ml|Participants will receive small 50ml boluses of fluid up to 250ml in total. The remainder will be given as infusion pump method at a rate of 1000ml/hour which will complete in 15 minutes. In total, the 500ml will be given over 25 minutes.
15977120|NCT03058653|Device|LIDCORapid Monitor|Addition of the LIDCORapid Monitor to measure stroke volume
15977121|NCT03058640|Other|PKSA karate class|"Participants will attend at least 20/24 PKSA karate classes over a 12 week period, completing standard karate training lessons. Participants will also be encouraged to practice on their own at home.
~• Participants must attend at LEAST 20/24 classes"
15977122|NCT03058627|Procedure|PCI|FFR guided PCI
15977123|NCT03058614|Drug|CEUS|In subjects randomized into the CEUS arm, 2 mL of Lumason will be injected as a single dose via a nephrostomy tube at the time of postoperative renal ultrasound, following by 5 mL of normal saline flush. Subjects will be given up to one additional dose injected in the same fashion as indicated during the imaging study to confirm opacification of the ureter.
15977124|NCT03058614|Diagnostic Test|Non-contrast CT scan|The CT scan performed in this study arm is regularly performed to evaluate the kidney and look for residual stones after surgery both at UCSF and around the world. It does not require contrast injection, so risks from contrast allergy or any injection are absent. A low dose protocol will be used, and therefore, subjects will be exposed to a very small amount of ionizing radiation as low as 1-2 mSv if randomized into this arm.
15977125|NCT03058614|Diagnostic Test|Capping trial|Subjects who are randomized into this study arm will undergo both nephrostomy tube capping and a low dose non-contrast CT scan on the first day after surgery. Successfully passing a capping trial is defined as the absence of fever, worsened flank pain, and leakage around the nephrostomy tube within 4 hours after capping the tube.
15977126|NCT03058588|Genetic|Analysis with molecular biology|Molecular screening by next generation sequencing (NGS) platform, for known and unknown mutations potentially associated with the disease
15977127|NCT03058575|Dietary Supplement|Dietary MACs|"All subjects will have a dose-escalation period when randomized to the active arm that will occur as follows:
~Day 1: 1 scoop of product (morning, in the clinic)
~Day 2: 1 scoop of product (morning)
~Day 3: 2 scoops of product (morning and evening)
~Day 4: 2 scoops of product (morning and evening)
~Days 5-60: 3 scoops of product (morning, afternoon, evening)
~Other Names:
~Dietary fiber supplement"
15977128|NCT03058575|Other|Control|No Intervention for 8 weeks
15977129|NCT03058562|Drug|ABX-1431|ABX-1431, capsules, 40 mg in the fasting state
15977130|NCT03058562|Drug|Placebo Comparator|Matching Placebo
15977131|NCT03058562|Drug|ABX-1431|ABX-1431, capsules, 20 mg with a high fat meal
15977132|NCT03058549|Behavioral|Family Expectations|Relationship education and referral services for expectant couples.
15977133|NCT03058536|Device|Arabin Pessary|The cervical pessary will be inserted at the randomization and removed during the 36 week of pregnancy, unless labour occurs sooner.
15977134|NCT03058536|Drug|Vaginal Progesterone|Treatment with 400 mg micronized progesterone daily, until the day of randomization to 36 weeks of pregnancy.
15977135|NCT03058536|Other|Arabin Pessary and Progesterone|Arabin Pessary and Progesterone The cervical pessary will be inserted at the randomization and removed during the 36 week of pregnancy, unless labour occurs sooner. Treatment with 400 mg Micronized progesterone daily, until the day of randomization to 36 weeks of pregnancy.
15977136|NCT03058510|Procedure|Frequency domain optical coherence tomography|OCT is an established medical imaging technique that uses light to capture high-resolution, three-dimensional images of blood vessels
15977137|NCT03058497|Device|Temperature-Controlled Laminar Airflow Device (Airsonett®)|
15977138|NCT03058484|Behavioral|Community Health Worker intervention|The intervention included four integrated components: 1) formal linkage of CHWs to health facilities; 2) CHW-led antiretroviral therapy (ART) adherence counseling; 3) loss to follow-up tracing by CHWs; and 4) distribution of Action Birth Cards (ABCs), a birth planning tool.
15977139|NCT03058471|Drug|Methotrexate|methotrexate arm will be given methotrexate starting at 10 mg weekly to be increased to 25 mg maximum in subsequent visits gradually
15977140|NCT03058471|Drug|NSAID|this arm will be given NSAID to the tolerable full dose with pantoprazole
15977141|NCT03058471|Drug|Steroids|inj. depot methyl prednisolone 80 mg ,2 doses deep intramuscularly given one week apart to all patients who have 5 or more swollen or tender joints
15977142|NCT03058458|Drug|PIN201104|IV or SC administration
15977143|NCT03058458|Drug|Placebo|IV or SC administration
15977144|NCT03058445|Device|Echocardiography|Substernal 4 chamber view obtained, then MMode applied to RA, then 5ml of saline is injected
15977145|NCT03058445|Device|CVC|Injection of 5 ml of saline
15977146|NCT03058432|Radiation|Radiotherapy alone|
15977147|NCT03058432|Radiation|Concurrent chemoradiotherapy|
15977148|NCT03058419|Drug|JNJ-54175446 150 mg|Subjects will receive JNJ-54175446 150 mg capsules orally (1*100 mg + 1*50 mg) under fasted conditions on Day 7, 9, 10 and 11.
15977149|NCT03058419|Drug|JNJ-54175446 600 mg|Subjects will receive JNJ-54175446 600 mg (6*100 mg capsules) orally on Day 8.
15977150|NCT03058419|Drug|Midazolam 2 mg|Subjects will receive midazolam 2 mg oral emulsion [2 (milligram per milliliter (mg/mL)] as a drug cocktail on Day 1, 7 and 11.
15977151|NCT03058419|Drug|Warfarin 10 mg|Subjects will receive warfarin 10 mg tablets (2*5 mg) orally as a drug cocktail on Day 1, 7 and 11.
15977152|NCT03058419|Drug|Caffeine 50 mg|Subjects will receive caffeine 50 mg tablet (1*50 mg) orally as a drug cocktail on Day 1, 7 and 11.
15977153|NCT03058419|Drug|Dextromethorphan 30 mg|Subjects will receive dextromethorphan 30 mg capsule (1*30 mg) orally as a drug cocktail on Day 1, 7 and 11.
15977154|NCT03058419|Drug|Bupropion 150 mg|Subjects will receive Bupropion 150 mg tablet (1*150 mg) orally as a drug cocktail on Day 1, 7 and 11.
15977156|NCT03058406|Drug|Eribulin mesylate|Participants will receive 1.4 milligrams per square meter (mg/m2) administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle and beyond.
15977157|NCT03058393|Other|Teach-Back Lesson|A teach-back lesson will be given to providers (teach-back group) who have challenging clinical discussions with patients
15977158|NCT03058380|Other|Stated-Preferences Evaluation Instrument|A discrete choice experiment (Stated-Preferences Evaluation Instrument) will be electronically configured using best practice stated-preference methods to quantify preferences for total knee replacement versus unicompartmental knee replacement surgery.
15977159|NCT03058367|Dietary Supplement|IQP-AE-103 (330mg)|High dose capsules
15977160|NCT03058367|Dietary Supplement|IQP-AE-103 (165mg)|Low dose capsules
15977161|NCT03058367|Dietary Supplement|Placebo|Placebo identical to verum capsules
15977162|NCT03058354|Drug|Propofol|Patient undergoing surgery at Queen Mary Hospital, Hong Kong between 2014 to 2016 using intraoperative TIVA with propofol.
15977163|NCT03058354|Procedure|general anaesthesia|Patient undergoing surgery at Queen Mary Hospital, Hong Kong between 2014 to 2016 using general anaesthesia methods other than intraoperative TIVA with propofol.
15977164|NCT03058341|Drug|propofol|Monitoring and other anaesthetic procedures including the management of hypertension and hypotension will be the same as group S. The only difference is that induction and maintenance of general anaesthesia will be conducted using total intravenous infusion of propofol. Sevoflurane will not be used, and oxygen and air would be given to provide a FiO2 of 30-50%.
15977165|NCT03058341|Drug|Sevoflurane|Propofol 1.5-3mg/kg, remifentanil 0.5-1mcg/kg, and rocuronium 0.6-1mg/kg or atracurium 0.5mg/kg will be used intravenously (IV) for induction of general anaesthesia. Otrivin can be applied nasally at the discretion of the anaesthetist. Intubation would be performed after induction of general anaesthesia. General anaesthesia monitoring will be used. Sevoflurane, air and oxygen will be used for maintenance of general anaesthesia. FiO2 will be kept between 35-50%. BIS monitoring will be applied and level of anaesthetia will be titrated to keep a BIS value of 40-60. Intravenous remifentanil infusion between 0.1-0.25mcg/kg/min will be given and this will be titrated to optimal haemodynamic parameters. Muscle relaxants can be given during the operation as required.
15977166|NCT03058328|Other|Cognitive testing, testing of heart rate variability and blood samples|
15977167|NCT03058302|Behavioral|CETA (Common Elements Treatment Approach)|The Common Elements Treatment Approach, or CETA, is a transdiagnostic psychotherapy based on cognitive behavioral elements for mood, anxiety and trauma related problems. CETA is based on the fact that most evidence-based mental health treatments (EBTs) consist of similar components. The objective of CETA is to provide a single training in a range of therapy components that are similar across EBTs and to then teach counselors how to design a specific course of treatment for each client based on the client's presenting problems.
15977168|NCT03058289|Drug|INT230-6|"INT230-6 is clear sterile solution administered by injection directly into the tumor to be treated.
~The product contains a cell permeation agent with cisplatin and vinblastine sulfate at fixed concentrations.
~The drug is stored frozen and must be dosed at room temperature.
~The drug dose to be administered is set by the tumor volume of the target lesions - not the subject's body surface area"
15977169|NCT03058289|Biological|anti-PD-1 antibody|The anti-PD-1 antibody will be added concomitantly with INT230-6 as noted in cohort DEC and DEC2
15977170|NCT03058289|Biological|anti-CTLA-4 antibody|The anti-CTLA-4 antibody will be added concomitantly with INT230-6 as noted in cohort FEC
15977171|NCT03058276|Behavioral|Retrieval-Extinction Learning|The intervention consists of the accomplishment of the task of approach-avoidance of alcohol during 4 days of training. Subjects are instructed to respond with an approach movement (pulling a lever) to neutral images and to respond with avoidance movement (pushing the lever) to images of alcohol.
15977172|NCT03058276|Other|rTMS|Previous to rTMS completion, MRI scans were performed in order to determinate the motor threshold trough 1Hz stimuli and locate the desired area with the neuronavigator. Motor threshold is defined as the stimulus with less intensity, able to generate a motor potential of at least 50 µV in 10 trials. Next, patients were called for 5 times per week, along 2 weeks, for receiving brain stimulation with Magstim Rapid coil. rTMS is performed at 10 Hz, during 4.9 seconds,for each set of stimuli (20), with a interval between sets of 30 seconds.
15977173|NCT03058276|Other|SAM|Previous to rTMS completion, MRI scans were performed in order to determinate the motor threshold trough 1Hz stimuli and locate the desired area with the neuronavigator. Motor threshold is defined as the stimulus with less intensity, able to generate a motor potential of at least 50 µV in 10 trials. Next, patients were called for 5 times per week, along 2 weeks, for receiving brain stimulation with SAM coil.
15977174|NCT03058263|Drug|Dose of Neostigmine|Subjects were given partial dose of neostigmine as rocuronium reversal after the surgery had finished; subjects were given TOF ratio-based dose of neostigmine after the surgery had finished
15977175|NCT03058250|Other|Transesophageal echocardiography|
15977176|NCT03058237|Drug|Arbaclofen Placarbil SR|One low dose oral tablet of Arbaclofen Placarbil sustained release (SR) in the fasted state.
15977177|NCT03058237|Drug|Arbaclofen Placarbil MR Prototype A|One low dose oral tablet pf Arbaclofen Placarbil modified release (MR) Prototype A in the fasted state; this formulation may also be tested with 0.6 g/kg beverage diluted in orange juice
15977178|NCT03058237|Drug|Arbaclofen Placarbil MR Prototype B|One low dose oral tablet of Arbaclofen Placarbil modified release (MR) Prototype B; this formulation may also be tested with 0.6 g/kg beverage diluted in orange juice
15977179|NCT03058237|Drug|Arbaclofen Placarbil IR|One low dose oral capsule of Arbaclofen Placarbil immediate release (IR) in the fasted state.
15977180|NCT03058224|Drug|IGN-ES001|Only active product will be compared with placebo as described in Arms and Interventions.
15977181|NCT03058224|Drug|Parol 500 mg Tablets (acetaminophen)|Analgesic Rescue Medication
15977182|NCT03058211|Diagnostic Test|Echocardiography|Standard protocols
15977183|NCT03058211|Diagnostic Test|Cardiac Magnetic resonance|MRI with late gadolinium increase and T1 mapping
15977184|NCT03058198|Diagnostic Test|89Zr-ABT806 PET|Patients will be given IV bolus injection of 89Zr-ABT806(1-2mCi). The first 89Zr-ABT806 PET scan will be performed about 72 to 120 hours after injection of tracer. The second 89Zr-ABT806 PET scan will be performed about 120 to 168 hours after injection of tracer. Semi-quantitative analysis was performed using the maximum standardized uptake value (SUVmax) and T/N ratio.
15977518|NCT03055741|Drug|Donepezil|5mg or 10mg, once a day, 24 weeks
15977185|NCT03058172|Other|Odor presentation (for participants' perception)|Several different odors will be diffused by an olfactometer under the participants' nostrils, though a controlled airflow, and synchronously with the participants' respiration. fMRI designs require repeated stimulus presentation. Odors will also be presented (in flasks or in odor pens) outside the scanner.
15977186|NCT03058172|Other|Image presentation (for participants' perception)|Several different pictures will be displayed in front of the participants' face, though a through a mirror system in the scanner, or on a computer screen outside the scanner.
15977187|NCT03058159|Other|fMRI|fMRI scans will be acquired before and after a 40 min nap slot in the afternoon. Functional connectivity between brain region will be assessed analyzing the scans with the CONN toolbox of the Statistical Parametric Mapping (SPM) software.
15977188|NCT03058146|Behavioral|Mobile Health Walking Condition|Physically inactive older adults in this condition (N=30) will perform 3 months of prescribed brisk walking (to increase cardio respiratory fitness) in their real world environments, using mobile health (mHealth) devices during each exercise session to achieve and maintain a minimum of 150 minutes of moderate to vigorous physical activity (MVPA) per week.
15977189|NCT03058146|Behavioral|Healthy Aging Education Condition|The education control condition (N=30) will provide participants with printed materials and homework assignments on issues related to successful aging, such as nutrition, social activity, cognitive and social engagement.
15977190|NCT03058133|Other|fMRI study|Functional brain activations of face-voice processing during a gender task
15977191|NCT03058120|Other|Deferral of admission for stress test|Early discharge; admission and stress test are deferred.
15977192|NCT03058107|Dietary Supplement|Nutrition Therapy|At the time of diagnosis, patients will immediately be screened and started with Nutrition Therapy if assigned to group A. This regimen will stay in place for 6 weeks to 3 months, after which a switch will be made towards normal dietary counselling. Nutrition Therapy can be given orally, parenterally or via tube feeding (enteral nutrition), depending on the patient's status and aims at matching Caloric Intake with Resting Energy Expenditure. Moreover, a switch between these modalities is possible. Afterwards, standard dietary counselling will be given during the remainder of the study. Follow-up will last one year. If 6 months after the last enrolment the study shows a large difference with the control group, the study will be stopped for ethical reasons.
15977193|NCT03058107|Dietary Supplement|Control Therapy|At the time of diagnosis, patients will immediately be screened and started with standard dietary counselling for 1 year if assigned to group B. Dietary intervention can be orally, parenterally or via tube feeding (enteral nutrition), depending on the patient's status. Moreover, a switch between these modalities is possible. Follow-up will last 1 year. If 6 months after the last enrolment the study shows a large difference with the control group, the study will be stopped for ethical reasons.
15977194|NCT03058094|Drug|Pemetrexed|Pemetrexed will be administered as an intravenous infusion over 10 minutes on Day 1 of each 21-day cycle. Folic acid will be administered 1-2 weeks prior to the 1st dose, then daily during the treatment period until 21days post the last dose. Vitamin B12 will be administered on the same day of pemetrexed infusion during the treatment period. Corticosteroid will be adminstered on the day prior to, on the day, and on the day after infusion.
15977195|NCT03058094|Drug|Cisplatin 75mg/m2|Cisplatin will be administered as an intravenous infusion.
15977196|NCT03058094|Drug|AC0010|300mg, orally, BID
15977197|NCT03058081|Device|High Flow nasal cannula|High intensity Constant Work-Rate exercise test with High Flow Nasal Cannula in COPD patients involved in a Pulmonary Rehabilitation Program after an exacerbation (< 7 days after hospital discharge). High Flow nasal will be administered through nasal cannula using the Airvo2 (Fisher&Paykel)
15977198|NCT03058068|Biological|Allo-hMSCs|1 peripheral intravenous infusion of allogeneic human mesenchymal stem cells (hMSCs)
15977199|NCT03058068|Biological|Placebo|1 peripheral intravenous infusion
15977200|NCT03058055|Behavioral|Placebo|The placebo group will have unstructured lifestyle activities (normal lifestyle activities without restraint).
15977201|NCT03058055|Behavioral|Origami|Origami lessons (one hour/week) with daily take home Origami activities to complete
15977202|NCT03058055|Behavioral|Reading|Book club that includes weekly one hour meetings and daily reading assignments
15977203|NCT03058042|Other|Exercises of the pelvic floor muscle at home|Patients will perform pelvic floor exercises at home.
15977204|NCT03058042|Other|Exercises of the pelvic floor muscle in the outpatient|Patients will perform pelvic floor exercises in the outpatient.
15977205|NCT03058029|Device|Gelesis200|Subject would take Gelesis200 capsules 2 times per day.
15977206|NCT03058029|Device|Placebo|Subject would take placebo capsules 2 times per day.
15977207|NCT03058016|Other|Personalized recommendations for diet|Personalized recommendations for effective diet, lifestyle and activities based on the patient's parameters measurements and reactions
15977208|NCT03058003|Diagnostic Test|Posturography Evaluation|Posturography testing using the extended modified Clinical Testing of Sensory Integration in Balance (ext_mCTSIB) protocol: the subjects will be required to stand on a hard or compliant surface in a comfortable posture, feet shoulder width, with eyes open or closed, arms to the side and free to move, gazing forward, and breathing normally, with head straight, turned right or left, flexed or extended
15977209|NCT03058003|Other|Central Sensitization Inventory|Standard chronic pain questionnaire: the subjects will be required to score each of the 25 items on a scale from 0 (never) to 4 (always)
15977210|NCT03057990|Drug|Pyrimethamine|Pyrimethamine will be administered 50mg/100mg/150mg once daily on days 1-28 of each 28-day cycle. Administered using intra-patient dose escalation, starting at 50 mg and up to 150 mg.
15977211|NCT03057977|Drug|Empagliflozin|once daily
15977212|NCT03057977|Drug|Placebo|once daily
15977213|NCT03057964|Device|PDL (Pulsed Dye Laser)|For those in the experimental group, at each treatment visit, the subject's scar will be treated with PDL followed by fractional photothermolysis.
15977214|NCT03057964|Device|Fractional Photothermolysis Laser|For those in the experimental group, at each treatment visit, the subject's scar will be treated with PDL followed by fractional photothermolysis.
15977215|NCT03057951|Drug|Empagliflozin|once daily
15977216|NCT03057951|Drug|Placebo|once daily
15977217|NCT03057938|Drug|18F-Florbetaben (FBB)|All participants will receive a single intravenous dose of 300 MBq of FBB followed by PET scan.
15977218|NCT03057925|Device|Microwave Ablation|Ultrasound-guided Percutaneous Microwave Ablation
15977219|NCT03057912|Biological|TALEN|TALEN gel consists of TALEN plasmid, C32-447, Poloxmer 407 and distilled water as solvent.
15977220|NCT03057912|Biological|CRISPR/Cas9|CRISPR/Cas9 gel consists of CRISPR/Cas9 plasmid, C32-447, Poloxmer 407 and distilled water as solvent.
15977221|NCT03057899|Drug|TFG capsules (200 mg /capsule)|TFG capsules were prepared using extracts from Trigonella foenum-graecum seed and Lespedeza cuneata. During the study period, two capsules were taken daily for 8 weeks.
15977222|NCT03057899|Drug|Placebo oral capsule|During the study period, two capsules were taken daily for 8 weeks. Placebo and TFG capsules were identical in shape, color, and taste.
15977223|NCT03057886|Device|Comparative thermometers to compare with a new device|The made up for the choice of the thermometer to be to general anesthesia the oral and new device (Spot On thermometers) before anesthesia induction, after anesthesia induction the Spot On, and oral, and esophageal thermometers and after surgery in PACU the Spot On and oral thermometer. In group submitted to spinal anesthesia the made up for the choice of the thermometer to be the oral and Spot On thermometers before anesthesia induction, after anesthesia induction the Spot On and oral thermometers and after surgery in PACU the Spot On and oral thermometer.
15977224|NCT03057873|Dietary Supplement|High protein, high fiber dietary supplement|Dry powder to be mixed with 10 ounces of cold water
15977225|NCT03057873|Dietary Supplement|Placebo|Dry powder to be mixed with 10 ounces of cold water
15977226|NCT03057860|Other|No study intervention|
15977227|NCT03057847|Drug|Sofosbuvir/Velpatasvir|Sofosbuvir/Velpatasvir One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period
15977228|NCT03057834|Behavioral|Pelvic floor muscle exercise|Standardized pelvic floor muscle exercise regimen
15977229|NCT03057821|Other|3% hydrogen peroxide|The treatment group will also undergo skin preparation with 3% hydrogen peroxide.
15977230|NCT03057808|Behavioral|Gestational weight gain intervention|This intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. The intervention will focus on self-monitoring, clear goals (i.e., GWG, caloric intake exercise), and problem solving.
15977231|NCT03057808|Behavioral|Postpartum weight loss intervention|The PPWL intervention will provide individual, telephone-based sessions (20-30 minutes each) by trained interventionists. (The number of possible telephone sessions will depend on the level of support needed by each participant to meet her weight loss goals). The PPWL intervention will focus on self-monitoring; weight, dietary intake and exercise goals; and problem solving.
15977232|NCT03057795|Drug|Brentuximab Vedotin|Given IV
15977233|NCT03057795|Other|Laboratory Biomarker Analysis|Correlative studies
15977234|NCT03057795|Biological|Nivolumab|Given IV
15977235|NCT03057782|Device|Waveguard (TM) EEG cap|The device is an EEG cap - a non-invasive EEG positioning system used to quickly place a large number of surface electrodes in a quick and consistent manner on the head. The device will measure electrophysiological signals from the scalp at the time points in the study listed in the protocol.
15977236|NCT03057782|Device|Micro Movement Sensor|This device is not FDA approved. This device is in clinical use for all age groups and used for research purposes by neurologists, physiologists and anesthesiologists. In this study, the device is used to monitor breathing and movement in children; the device is not used for validation purposes.
15977237|NCT03057782|Device|Pico Movement Sensor|This device is not FDA approved. This device is in clinical use for all age groups and used for research purposes by neurologists, physiologists and anesthesiologists. In this study, the device is used to monitor respiration rate and gross body movement in children. The device will not be used for validation purposes.
15977238|NCT03057782|Device|QS Piezostimulator|This device is not FDA approved. This device is used for research purposes by neurologists and physiologists. It is a mechanical tactile stimulator for use in functional imaging experiments like MEG, fMRI or EEG. The stimulation is realized by using several different pin matrices. In this study, the device is used to stimulate the children's extremities in order to elicit somatosensory evoked responses.
15977239|NCT03057782|Device|tactileTM sensory evaluator|This device is not FDA approved. This device is used for clinical and research purposes by neurologists and physiologists. It is used to stimulate the children's extremities in order to elicit somatosensory evoked responses.
15977240|NCT03057769|Drug|Papillary epinephrine spraying|All patients in this group receive 20 ml of 0.02% epinephrine sprayed on the duodenal papilla, over a period of 10-15 seconds using sphincterotome, at the end of procedure, just before the withdrawal of endoscope.
15977241|NCT03057769|Drug|Papillary saline spraying|All patients in this group receive 20 ml of saline sprayed on the duodenal papilla, over a period of 10-15 seconds using sphincterotome, at the end of procedure, just before the withdrawal of endoscope.
15977242|NCT03057769|Drug|Indomethacin|All patients without contraindications should be administrated with rectal indomethacin within 30 min before ERCP.
15977243|NCT03057756|Combination Product|Km+ Mfx+ Pto + H + Cfz +E+Z|Second generation of anti tuberculosis Kanamycine, Moxifloxacine,Prothionamide, isoniazide,Clofazimine, Ethambutol,Pyrazinamide
15977244|NCT03057743|Device|Positron emission tomography (PET/CT) imaging|
15977245|NCT03057743|Device|radiotracer [18F]ISO-1|
15977246|NCT03057730|Biological|Acellular Dermal Matrix|ADM is a human-derived allograft material, treated to remove all cellular components so that only the connective tissue matrix remains.
15977247|NCT03057717|Other|2D ultrasound assessment|2D ultrasound assessment of fetal thymus size with measurements of the maximum transverse diameter and thymus perimeter
15977248|NCT03057704|Drug|Lidocaine injection flushed|The investigator administers IV lidocaine and flushes it into the subject prior to administering propofol.
15977249|NCT03057704|Drug|Lidocaine injection tourniquet|Intravenous lidocaine: tourniquet
15977250|NCT03057691|Other|antidepressive and anti-anxiety therapy|These therapies include antidepressants, antianxiety drugs and psychotherapy. Subjects choose the therapy follow their own will. All of the above-mentioned therapies are identified by experienced psychiatrists in the same center. The treatment information will be recorded in each visit. The study is considered non-interventional, and no antidepressive or anti-anxiety therapies are mandated.
15977251|NCT03057678|Other|Testing of Pre-Positioning Frame|Placement of bone screws, CT scanning, Surgical planning, Robot motion planning
15977252|NCT03057665|Device|Atomic Biomagnetometer|Measure magnetic field of fetal heartbeat
15977317|NCT03057132|Device|Cavilon Advanced Skin Protectant|Cavilon Advanced Skin Protectant
15977253|NCT03057652|Device|ReWalk|"ReWalk is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices.
~ReWalk training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. ReWalk phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours."
15977254|NCT03057652|Device|EKSO|"EKSO is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices.
~EKSO training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. EKSO phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours."
15977255|NCT03057652|Device|REX|"REX is a type of wearable robotic exoskeleton (WRE). Subjects will be randomly assigned the order of participation in the exoskeleton devices.
~REX training sessions will be scheduled for one hour to include don/doff of device, sit to stand, standing balance and walking. REX phase will require 2 hours pre and 2 hours post training for outcome measurement assessments, plus a minimum of 5 training sessions, with the possibility of up to 15 training sessions to reach a minimal assistance level. The total time commitment for each subject will range from 14-20 weeks and cover 27-72 hours."
15977256|NCT03057639|Other|Quality-of-Life Assessment|Ancillary studies
15977257|NCT03057639|Other|Questionnaire Administration|Ancillary studies
15977261|NCT03057613|Drug|Pembrolizumab|200mg every 3 weeks for 16 weeks given by IV infusion
15977262|NCT03057613|Radiation|IMRT 60-66Gy|60-66Gy for 6 weeks
15977263|NCT03057600|Drug|Paclitaxel|standard weekly paclitaxel in 28-day cycles
15977264|NCT03057600|Drug|CB-839|CB-839 administered as oral tablets twice daily (BID)
15977265|NCT03057587|Device|NIRS Monitoring|NIRS data will be collected throughout the surgery
15977266|NCT03057574|Drug|Follitropin Alfa|Patients must be prescribed Follitropin Alfa (Gonapure®)
15977267|NCT03057561|Drug|Cardiac MRI taken using contrast agent, Dotarem® (Gd-DOTA)|Gadolinium based contrast agent used in cardiac MRI scanning using 3.0 Tesla MRI
15977268|NCT03057561|Drug|Cardiac MRI with contrast agent, Gadovist|Brand of Gd-DO3A-butrol; contrast agent used in cardiac MRI scanning using 3.0 Tesla MRI
15977269|NCT03057548|Procedure|Cryo or RF Ablation only of Pulmonary Veins|"Artic Front Advance Cardiac Cryoabltion System used to ablate the Pulmonary Veins
~OR
~FDA Approved RF Ablation Catheter used to ablate the Pulmonary Veins.
~Ablation of the Pulmonary Veins alone"
15977270|NCT03057548|Procedure|Cryo or RF Ablation of Pulmonary Veins plus Ablation of the PLAW|"Cryoablation of the Pulmonary Veins plus RF Ablation of the PLAW
~OR
~RF Ablation of the Pulmonary Veins plus RF Ablation of the PLAW
~Ablation of the Pulmonary Veins plus RF ablation of the Posterior Left Atrial Wall (PLAW)"
15977271|NCT03057535|Drug|Sodium Bicarbonate|
15977272|NCT03057535|Drug|Sodium Chloride|
15977273|NCT03057522|Behavioral|Change in running cadence|The intervention will involve a home exercise program designed to increase the running cadence in recreational runners.
15977274|NCT03057509|Drug|Ga-68-DOTA-TOC|Ga-68-DOTA-TOC is a imaging radiotracer that is used for positron emission tomography imaging of a variety of the neuroendocrine tumors. This radiotracer in the body binds to several subtypes of the somatostatin receptor and accumulates in the tissue with high expression of these receptors. Therefore neuroendocrine tumors that express somatostatin receptors can be imaged using this radiotracer.
15977275|NCT03057509|Device|Siemens PET/MR scanner|Positron emission tomography-magnetic resonance (PET/MR) is a hybrid imaging technology that incorporates magnetic resonance imaging (MRI) soft tissue morphological imaging and positron emission tomography (PET) functional imaging. The Siemens PET/MR system (Biograph mMR) received a CE mark and FDA approval for clinical diagnostic imaging.
15977276|NCT03057509|Other|Standard Siemens Software|The Siemens PET/MR scanner are equipped with a standard clinical visualization software with the advanced application tools based on the Siemens image interpretation engine called syngo.via. This software allows for visualization and interpretation of the image data-sets in the clinical environment.
15977277|NCT03057509|Drug|LAR Octreotide|LAR octreotide is a man-made protein that is similar to a hormone in the body called somatostatin. LAR Octreotide lowers many substances in the body such as insulin and glucagon, growth hormone, and chemicals that affect digestion. LAR octreotide is used to treat a variety of clinical conditions but most importantly to reduce flushing episodes and watery diarrhea caused by cancerous tumors such as neuroendocrine tumors.
15977278|NCT03057496|Device|Collision warning device|The collision warning device is a pocket-sized, electronic system that includes a micro-computer, a clip-on miniature camera, a gyro-sensor, an accelerometer, and a rechargeable battery, all contained within a shoulder bag. It is about the size of a smart phone. When a potential collision is detected by the device it emits a warning to the user, either in the form of an audible beep or a tactile warning through bracelets worn on the wrist. The time to collision will be coded in both the auditory and tactile domains. The device is designed to only give warnings about high risk collisions, so the users will not be continually bombarded by warnings for every potential collision object in the environment.
15977279|NCT03057483|Biological|Seasonal Influenza vaccine|Seasonal Influenza vaccine
15977280|NCT03057470|Drug|50% bolus insulin correction|Patients will receive 50% of their usual bolus insulin correction for post-exercise hyperglycemia
15977281|NCT03057470|Drug|100% bolus insulin correction|Patients will receive 100% of their usual bolus insulin correction for post-exercise hyperglycemia
15977282|NCT03057470|Drug|150% bolus insulin correction|Patients will receive 150% of their usual bolus insulin correction for post-exercise hyperglycemia
15977283|NCT03057470|Other|0% bolus insulin correction|Patients will receive no bolus insulin correction for post-exercise hyperglycemia
15977354|NCT03056911|Drug|Ozone|Pain relief with chemonucleolysis by using ozone regard to age, sex, ASA score, and complications.
15977284|NCT03057457|Device|NGAL Test|The purpose of this study is to demonstrate that BioPorto Diagnostic's NGAL test is able to assist in determining the risk for acute kidney injury for patients who have been admitted to the intensive care unit.
15977285|NCT03057444|Dietary Supplement|SymbioIntest|The intervention is 2x 5g per day the food supplement SymbioIntest (resistant starch types III) over 8 weeks.
15977290|NCT03057418|Drug|Aurixim|Administration will be performed once a week during 4-week induction period, and then once per 12 weeks during supporting period, if necessary. Total maximum duration of the investigational therapy - 1 year, during which patients will receive up to 8 infusions of Aurixim.
15977291|NCT03057392|Other|immersion|participants will sit in a 34-35C while receive dialysis
15977292|NCT03057392|Other|sham session|dialysis while sitting in the dialysis chair
15977293|NCT03057379|Other|Vaccine Reminder Recall|The investigators will be sending recall notices via phone call to 11-17 year olds who are eligible but lacking HPV vaccine doses recorded in the New York State Immunization Information System (NYSIIS). The investigators will be testing the effectiveness and cost effectiveness of up to 3 notices per dose with usual care (no intervention)
15977294|NCT03057366|Drug|Pevonedistat|Pevonedistat intravenous infusion.
15977295|NCT03057366|Drug|[14C]-Pevonedistat|[14C]-Pevonedistat intravenous infusion.
15977296|NCT03057366|Drug|Docetaxel|Docetaxel intravenous infusion.
15977297|NCT03057366|Drug|Carboplatin|Carboplatin intravenous infusion.
15977298|NCT03057366|Drug|Paclitaxel|Paclitaxel intravenous infusion.
15977299|NCT03057353|Device|lumbar CT imaging|Collecting lumbar CT imaging data of 104 patients with lumbar spinal stenosis to observed the incidence of ligamentum flavum hypertrophy of patients with different nationalities, sexes, heights, ages, and weights and explored risk factors affecting ligamentum flavum hypertrophy.
15977300|NCT03057340|Biological|Dribble vaccine|DRibble vaccine with DC/CIK(The experimental group) DRibble vaccine will be administered at day1,22,55
15977301|NCT03057327|Behavioral|Improve awareness of checking moles|"Intervention:
~Improve awareness Each of the eight changing rooms will have a large mirror that can be used to see the face and chest. Each room will be equipped with a poster, brochures and the SSE kit consisting of the laminated card with a ruler on one edge and the magnifying lens will be fastened to the wall on a cord.
~Provide education The subject may chose to read the poster and a brochure. c) A woman research assistant will perform in-person exit interviews with participants to ascertain if women noticed the poster, and found the information relevant."
15977302|NCT03057327|Other|Comparator|Prior to placing the intervention materials into the changing rooms, 100 eligible subjects will be asked if they regularly check their moles for concerning features. If the response is yes, then they will be asked if they have found concerning moles and what they did next.
15977303|NCT03057314|Drug|Amorphous Calcium Carbonate|"Subjects will be administered with:
~ACC tablets, containing 200 mg elemental calcium
~1% ACC (i.e. 0.3% calcium) + 5 mL Water for Injection, as a sterile suspension"
15977304|NCT03057301|Device|iCare home tonometer|All subjects will be taught to use the home care tonometer.
15977305|NCT03057288|Device|fiducial markers placement|The main objective of this study is to evaluate the feasibility of fiducial markers placement under EUS guidance for patients with esophageal or rectal cancer with an indication of radiotherapy
15977306|NCT03057275|Device|Abdominal fetal/maternal monitoring|A single patch placed on the abdomen that incorporates 5 electrodes and a monitoring device
15977307|NCT03057262|Device|Repositioning splint|Application of repositioning splint in the study group.
15977308|NCT03057249|Other|Dynamic infrared thermography (DIRT)|Evaluating abdominal skin perfusion with DIRT
15977309|NCT03057236|Behavioral|Cognitive Behavior Coping Skills|The CBCS-HCV is a psychosocial intervention delivered in group format. Through 9 group sessions, patients will learn coping skills, relaxation techniques and other new cognitive and behavioral skills based on several empirically-supported cognitive behavioral interventions.
15977310|NCT03057223|Device|3D-printed patient-specific titanium plates|3D-printed patient-specific titanium plates will be used in patients.
15977311|NCT03057210|Other|Stress Protocol|Participants will be submitted to an exercise protocol consisting of a jumping program and a maximum short cycle test (ALMEIDAetal). The jumping program consists of 10 sets of 10 jumps with one minute interval between sets. The participants will then perform the Wingate Anaerobic Test protocol, which will be performed on a Biotec 2100 cycle ergometer (Cefise, Nova Odessa, Brazil). A 5-minute warm-up will be carried out where the participant will pedal at a speed of 60 to 90 rpm with a fixed load of 1.0 kg and perform sprints in the 2nd and 4th minute and the test itself, which consists of a maximum of pedals In 30 seconds with a stipulated load of 0.075 kP · kg-1 of the participant's body mass.
15977312|NCT03057210|Other|Massage Protocol|"the present protocol will have a total of 12 minutes duration, being six minutes in the anterior region of the thigh (three minutes for each limb) and six minutes in the posterior region of the trunk.
~Surface and deep sliding techniques will be used, the latter being presented in two intensities, moderate or intense, gradually increased. The massage will be performed towards the muscle fibers, from distal to proximal and following the lymphatic flow. In addition to the standardization of the intensity of the massage performed by the physiotherapist, in order to avoid causing discomfort and possible variations in the application of the technique, participants should report their level of comfort from a scale that considers the technique light, moderate or Intense, corresponding respectively to surface slip, Deep Slip 1 and Deep Slip 2."
15977313|NCT03057197|Procedure|new caudal injection technique|new caudal injection technique is applied to the Group B, which is that the needle only penetrates the sacrococcygeal ligament without being inserted into the sacral canal
15977314|NCT03057184|Behavioral|Intervention|The intervention will consist of 8 weekly sessions, with a duration of 90 minutes. Although each intervention is adapted to the specific behavioral problems
15977315|NCT03057145|Drug|Prexasertib|LY2606368 is a checkpoint kinase 1 (CHK1) inhibitor that is being developed as a treatment for patients with advanced cancer
15977316|NCT03057145|Drug|Olaparib|Olaparib is a poly (ADP-ribose) polymerase (PARP) inhibitor.
15977318|NCT03057119|Behavioral|Psycho-educational content (5 Minutes)|The interventionist will discuss substance use and misuse and the influence of substance use on self care.
15977319|NCT03057119|Behavioral|Readiness Assessment (10 minutes)|The interventionist will give the patient feedback on their ASSIST score and assess the patient's readiness to change based on Prochaska's stages of change.
15977320|NCT03057119|Behavioral|Goal-Setting (5 minutes)|The interventionist will use motivational interviewing techniques to identify the patients' most salient reasons for addressing substance use issues.
15977321|NCT03057119|Behavioral|Identifying and prioritizing needs (5 minutes)|The interventionist will use problem-solving techniques to help patients identify which services may best help them work towards their goals. Services will include (but are not limited to) emergency crisis services, counseling to deal with substance use, referral to local self-help groups (Alcoholics Anonymous, Narcotics Anonymous, etc.), legal assistance, faith-based counseling, mental health counseling or inpatient substance use treatment.
15977322|NCT03057119|Behavioral|Explanation of Peer Navigator and Session wrap (5 minutes)|The interventionist will use a referral resource guide to provide the contact information of agency representatives and help the patient formulate a plan for follow-up.
15977323|NCT03057106|Drug|Durvalumab|MEDI4736
15977324|NCT03057106|Drug|Tremelimumab|Tremelimumab
15977325|NCT03057106|Drug|Platinum-Based Drug|Pemetrexed, cisplatin, carboplatin or gemcitibine
15977326|NCT03057093|Other|Non interventional study|retrospective noninterventional study
15977327|NCT03057080|Procedure|Percutaneous transluminal angioplasty (PTA)|The main goal of the angioplasty (which was also the definition of technical success) was to achieve straight-line flow (SLF) from the aorta down to either a patent dorsalis pedis or plantar arch.
15977328|NCT03057067|Procedure|Embolization of pelvic vein varicosities|Embolization of pelvic vein varicosities
15977329|NCT03057054|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo alloHCT
15977330|NCT03057054|Biological|Lactobacillus plantarum strain 299|Given PO or via NJ, NG or G tube
15977331|NCT03057054|Biological|Lactobacillus plantarum strain 299v|Given PO or via NJ, NG or G tube
15977332|NCT03057054|Other|Placebo Administration|Given PO or via NJ, NG or G tube
15977333|NCT03057041|Drug|Fentanyl|100 mcg of intranasal fentanyl, 50 mcg/ mL in each nostril via mucosal atomizer 15 minutes prior to procedure start
15977334|NCT03057041|Drug|placebo|1 mL of sterile saline in each nostril via mucosal atomizer 15 minutes prior to procedure start
15977335|NCT03057028|Drug|Anakinra|
15977336|NCT03057015|Drug|Clonidine|50 mcg Clonidine added to the solution of 0.5% ropivacaine, 2 mg dexamethasone and 5 mcg/ml epinephrine for adductor canal block-present in the treatment group.
15977337|NCT03057015|Drug|Placebo|Normal saline added to the solution of 0.5% ropivacaine, 2 mg dexamethasone and 5 mcg/ml epinephrine for adductor canal block-present in the placebo group.
15977338|NCT03057015|Drug|Ropivacaine|Clonidine or Placebo added to the solution of 0.5% ropivacaine, 2 mg dexamethasone and 5 mcg/ml epinephrine for adductor canal block-present in both treatment and placebo groups.
15977339|NCT03057015|Drug|Dexamethasone|Clonidine or Placebo added to the solution of 0.5% ropivacaine, 2 mg dexamethasone and 5 mcg/ml epinephrine for adductor canal block-present in both treatment and placebo groups.
15977340|NCT03057015|Drug|Epinephrine|Clonidine or Placebo added to the solution of 0.5% ropivacaine, 2 mg dexamethasone and 5 mcg/ml epinephrine for adductor canal block-present in both treatment and placebo groups.
15977341|NCT03057002|Drug|Hyperpolarized 13C-Pyruvate|All subjects will be observed for myocardial hyperpolarized [1-13C]pyruvate flux during magnetic resonance spectroscopic imaging.
15977342|NCT03056989|Drug|SPX-101|Inhalation solution twice daily for 7 days.
15977343|NCT03056976|Device|Single-implant mandibular overdenture|Complete mandibular denture retained by a single midline implant
15977344|NCT03056976|Device|Two-implant mandibular overdenture|Complete mandibular denture retained by two implants in the canine region
15977345|NCT03056976|Device|Fixed mandibular denture|A fixed mandibular denture retained by four implants
15977346|NCT03056963|Behavioral|Positive Self-Reference Training|Participants in this intervention will review a brief psychoeducational video describing the training, and then be given cues every other day designed to practice skills. Participants will then practice visualizing and describing scenes based on these cues. This training will be focused on positive self-referent material.
15977347|NCT03056963|Behavioral|Neutral Training Control|Participants in this intervention will review a brief psychoeducational video describing the training, and then be given cues every other day designed to practice skills. Participants will then practice visualizing and describing scenes based on these cues. This training will be focused on neutral, non-self-referent material.
15977348|NCT03056950|Device|DELFI PTS ii portable tourniquet|A cuff will be wrapped around the most proximal portion of the arm of the involved extremity. In order to individualize the pressure for each subject, the limb occlusion pressure will be measured (with doppler ultrasound over the radial artery at the wrist level) at the first scheduled therapy visit. The cuff pressure utilized during the post-operative exercises will be set at 50% of the limb occlusion pressure. The subjects' strength will be re-assessed approximately every 2-4 weeks and the load will be increased as tolerated.
15977349|NCT03056937|Other|Bariatric surgery|evaluations pre and post bariatric surgery.
15977350|NCT03056937|Other|Control|without intervention, it will be performed only evaluations
15977351|NCT03056924|Biological|Pneumococcal Pneumonia vaccine|Vaccination for pneumococcal pneumonia will be carried out with either the PSV-23 (Pneumovax, Merck, Whitehouse Station, NJ) or the PCV-13 (Prevnar 13, Pfizer, Philadelphia, PA). Either vaccine is administered in a single dose of 0.5 mL intramuscularly.
15977352|NCT03056924|Biological|Influenza vaccine|Influenza vaccination will be carried out with the 2017-2018 trivalent component vaccine (Afluria, Seqirus USA Inc., King of Prussia, PA) or for patients over 65 years of age (Fluzone, Sanofi Pasteur, Swiftwater, PA). Both of these vaccines are administered in a single dose of 0.5 mL intramuscularly.
15977353|NCT03056924|Biological|Hepatitis B vaccine|Hepatitis B vaccination with be carried out with a single antigen, recombinant hepatitis B vaccine (Energix B, GlaxoSmithKline, Research Triangle Park, NC). This vaccine is administered in a three dose series with 1.0 mL given intramuscularly at 0, 1, and 6 months. For patients receiving a booster, a single intramuscular dose of 1.0 mL will be given.
15977357|NCT03056859|Device|Extravascular blood pressure transducer|Listed device is included in central venous catheter placement apparatus for consenting patients, according to manufacturer directions
15977358|NCT03056846|Dietary Supplement|Placebo|Placebo will be taken as a capsule twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
15977359|NCT03056846|Dietary Supplement|Probiotic Combination|A capsule containing a mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) will be taken twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
15977360|NCT03056846|Dietary Supplement|Bifidobacterium bifidum|A capsule containing Bifidobacterium bifidum (1.5 billion cells per capsule prior to expiration) will be taken twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
15977361|NCT03056846|Dietary Supplement|Bifidobacterium longum|A capsule containing Bifidobacterium bifidum (1.5 billion cells per capsule prior to expiration) will be taken twice daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). Inactive ingredients include gelatin, potato starch, and silica.
15977362|NCT03056833|Drug|ribociclib|Ribociclib (LEE-011) will be given on days 1-4, 8-11, and 15-18 of a 28 day cycle at 200, 400, or 600mg/day during the dose escalation phase. During the maintenance phase, ribociclib (LEE-011) will be given at 600mg/day, 3 weeks on, 1 week off until progression.
15977363|NCT03056833|Drug|Paclitaxel|During the escalation phase Paclitaxel will be given on days 1, 8, and 15 of a 28 day cycle.
15977364|NCT03056833|Drug|Carboplatin|During the escalation phase Carboplatin will be given on days 1, 8, and 15 of a 28 day cycle.
15977365|NCT03056820|Other|25° head-up position|Participant will be positioned at 25° angle for procedure.
15977366|NCT03056820|Other|55° head-up position|Participant will be positioned at 55° angle for procedure.
15977367|NCT03056807|Other|25° head-up position|Angle person is positioned for procedure.
15977368|NCT03056807|Other|55° head-up position|Angle person is positioned for procedure.
15977370|NCT03056781|Behavioral|social interaction|Participants will engage in a social interaction with another person
15977371|NCT03056781|Behavioral|food consumption|Participants will be offered food stuffs to eat/drink
15977372|NCT03056768|Behavioral|Multidomain intervention|1-year multidomain health promotion (physical, cognitive, nutritional intervention)
15977373|NCT03056768|Behavioral|Active control|Health promotion activities provided by local health bureau.
15977379|NCT03056742|Biological|Stempeucel(R)|Ex vivo cultured adult bone marrow derived allogeneic mesenchymal stem cells
15977380|NCT03056729|Drug|BIIB076|Administered as single intravenous (IV) infusion
15977381|NCT03056729|Drug|Placebo|Administered as single IV infusion
15977382|NCT03056716|Procedure|Silastic vs conventional drain in thoracic surgery|Apical drains will be identical in size and material, and the basal drains will be different in groups. The patients will be followed for daily amounts of fluid drainage, duration of air leaks and fluid drainage, and duration of hospitalization, and the results will be compared statistically to asses any possible relationships with the outcome and the type of basal drain used.
15977383|NCT03056703|Drug|Acetylsalicylic acid (Aspirin, BAY1019036)|One Fast Release Tablet containing 1000 mg acetylsalicylic acid
15977384|NCT03056703|Drug|Acetylsalicylic acid (Aspirin, BAY1019036)|Two Fast Release Tablets containing 500 mg acetylsalicylic acid each
15977385|NCT03056690|Drug|ASP0819|Oral capsule
15977386|NCT03056690|Drug|Placebo|Oral capsule
15977387|NCT03056677|Dietary Supplement|Control|200mls water will be given prior to a mixed carbohydrate meal
15977388|NCT03056677|Dietary Supplement|Normal Whey protein|Whey protein (50grams) drink will be given prior to a mixed carbohydrate meal
15977389|NCT03056677|Dietary Supplement|Modified whey protein|Modified whey protein (50grams) drink will be given prior to a mixed carbohydrate meal
15977390|NCT03056664|Procedure|Routine drainage surgery|
15977391|NCT03056664|Biological|MSC injection 01|Local MSC injection in peri-anal with a dose of 3×10E6/kg
15977392|NCT03056664|Biological|MSC injection 02|Local MSC injection in peri-anal with a dose of 6×10E6/kg
15977393|NCT03056664|Other|placebo|NS injection instead of MSC
15977394|NCT03056651|Other|treatment in day-care heart failure unit|
15977395|NCT03056638|Drug|Degarelix|Degarelix monthly for 6 months
15977396|NCT03056638|Radiation|stereotactic body radiosurgery (SBRT)|SBRT 8 Gy x 5
15977397|NCT03056625|Other|Vitamin A fortified rice|Lactating women will receive fortified rice one meal per day on weekdays for a period of 14 weeks.
15977398|NCT03056625|Other|Normal rice|Lactating women will receive normal rice one meal per day on weekdays for a period of 14 weeks.
15977399|NCT03056612|Other|Observation protocol|The whole cohort will be followed for 3 months, while Group 1 will be followed more closely.
15977400|NCT03056599|Drug|Multiple drug microinjection|This is a feasibility study in patients with localized or metastatic soft tissue sarcoma undergoing surgery to determine how sarcoma in situ responds to injected microdoses of anti-cancer therapeutics.
15977401|NCT03056599|Device|CIVO device|Feasibility of assessing drug response to precise local injection of anti-cancer drugs using Presage's CIVO device in soft tissue sarcoma patients undergoing surgery.
15977402|NCT03056586|Device|vaginal pessary|A vaginal pessary will be inserted at the end of the operation, for genital prolapse, and will be sutured to the vaginal wall. The pessary will stay in the vagina for 4 weeks.
15977403|NCT03056573|Device|Transaortic TAVR Implant|Transaortic TAVR implant
15977405|NCT03056560|Behavioral|TakeCARE (video bystander program)|brief video encouraging active responses to high-risk situations for campus violence
15977406|NCT03056547|Other|Induced dyspnea|"Biological samples will be assessed during and after breathing discomfort induced by laboratory models of dyspnea (work/effort, air hunger)."
15977407|NCT03056534|Device|R3 Biolox Delta Ceramic Acetabular System|All study related procedures with the R3 delta Ceramic Acetabular System must be performed according to the recommended surgical technique described in the labeling and in the instructions for use (IFU).
15977408|NCT03056521|Other|preoperative information about pain|It is information about analgesics, post operative pain, complications of pain, benefits of pain treatment and non pharmacologic treatment options.
15977409|NCT03056508|Behavioral|Exercise plus nutrition|On the same day as the exercise class, participants will also receive nutrition support. Participants will alter their overall diet to be consistent with recommendations outlined in our brain health food guide (BHFG) and receive diet counseling and strategy training to promote retention and enable this dietary change. For the first two months, diet group sessions will be held on a weekly basis. For the remaining four months, sessions will be divided between group sessions and individual meetings with study dietitians, on a predefined schedule. Participants will submit weekly logs outlining diet goals, plans, successes and obstacles to help direct identification of sequential goals.
15977410|NCT03056508|Behavioral|Exercise|Supervised group exercise will be performed once per week (60 minutes) and self-directed exercise (4 additional aerobic and 2-3 resistance training sessions per week) will be monitored by an exercise diary. The initial walking prescription will be set at ~1.6 km and an intensity equivalent to the anaerobic threshold and/or 60% VO2-peak. Progressions will be made every 2 weeks, increasing distance to a maximum of 6.4 km and then increasing to a max intensity of 80% of VO2-peak and/or max duration of 60 minutes. Heart rate and perceived exertion will be monitored. The program will last 6 months.
15977411|NCT03056495|Drug|N-hydroxy-N'-phenyl-octanediamide (Vorinostat)|N-hydroxy-N'-phenyl-octanediamide capsules once a day, three weeks of treatment; dose escalation with different dosages per cohort; One cohort of three subjects
15977412|NCT03056482|Drug|Ondansetron 8mg|Ondansetron 8 MG prepared in a 100 mL normal saline min-bag
15977413|NCT03056482|Drug|Haloperidol 0.05mg/kg|Haloperidol 0.05 mg/kg prepared in a 100 mL normal saline min-bag
15977414|NCT03056482|Drug|Haloperidol 0.1mg/kg|Haloperidol 0.1 mg/kg prepared in a 100 mL normal saline min-bag
15977415|NCT03056469|Other|Completion of patient-reported outcome (PRO) questionnaires|Patient-reported outcome (PRO) questionnaires are completed at home within one week before a patient-physician consultation at the outpatient clinic. The questionnaires are submitted online or on paper depending on the participants choice.
15977416|NCT03056456|Drug|LY900014|Administered subcutaneously (SC)
15977417|NCT03056456|Drug|Insulin Lispro (Humalog)|Administered SC
15977418|NCT03056443|Device|Continuous Positive Airway Pressure (CPAP)|The auto-CPAP group will be scheduled for follow-up with a phone call at 2 - 3 weeks post discharge, then in sleep medicine clinic at 1 month (+2 weeks) and 6 months (+2 weeks) to assess their progress on CPAP.
15977419|NCT03056430|Behavioral|Training|
15977420|NCT03056417|Behavioral|The Complete Health Improvement Program|The Complete Health Improvement Program is a nationally recognized program that encourages a diet of whole plant based foods, moderate exercise, stress reduction, and social support.
15977421|NCT03056404|Other|additional blood sample|
15977422|NCT03056404|Other|respiratory functional exploration|
15977423|NCT03056391|Drug|Paracetamol|">50kg: Paracetamol 1gm PO/NG 6 hourly for 72 hours (maximum dose 4g/24h) plus IV artesunate or oral artemether/lumefantrine.
~<50kg: Paracetamol 12.5-15mg/kg/dose 6 hourly for 72 hours (maximum total dose 5doses/24hours;75mg/kg) plus IV artesunate or oral artemether/lumefantrine."
15977424|NCT03056378|Biological|Standard RBCs|Transfusion of standard pRBCs that are matched for C, E and K
15977425|NCT03056365|Procedure|Advanced Nurse (AN)|Protocoled AN-based management of detox
15977426|NCT03056365|Procedure|General Practitioner (GP)|'As usual' medical management of detox
15977427|NCT03056352|Drug|Metoclopramide|Intravenous medication drip
15977428|NCT03056352|Drug|Diphenhydramine|Intravenous medication drip
15977429|NCT03056339|Drug|Fludarabine|30 mg/m2 by vein on Days -5 to -3.
15977430|NCT03056339|Drug|Cyclophosphamide|300 mg/m2 by vein on Days -5 to -3.
15977431|NCT03056339|Drug|Mesna|300 mg/m2 by vein on Days -5 to -3 before and after the cyclophosphamide dose.
15977432|NCT03056339|Biological|iC9/CAR.19/IL15-Transduced CB-NK Cells|"Infusion of iC9/CAR.19/IL15-transduced CB-NK cells on Day 0 by vein.
~Starting dose: 10E5"
15977433|NCT03056339|Drug|AP1903|If participant has graft-versus-host disease (GvHD) or cytokine release syndrome after the NK cell infusion, they will receive AP1903 0.4 mg/kg administered as an intravenous infusion.
15977434|NCT03056326|Drug|CHF6333 (Part 1 - SAD)|Single doses of CHF6333 at each period
15977435|NCT03056326|Drug|Placebo (Part 1 - SAD)|Single doses of placebo matching CHF6333 at each period
15977436|NCT03056326|Drug|CHF6333 (Part 2 - MAD)|once daily multiple doses of CHF6333 for 14 days
15977437|NCT03056326|Drug|Placebo (Part 2 - MAD)|once daily multiple doses of placebo matching CHF6333 for 14 days
15977438|NCT03056313|Behavioral|Proactive support of labor|In case of delayed labor, active labor is defined at an earlier stage; labor support is given with 1 cm opening of the cervix and painful contractions. Labor support interventions are started then.
15977439|NCT03056313|Behavioral|support of labor as usual|In case of delayed labor, active labor start is defined as usual at 3-4 cm opening of the cervix and regular contractions. Labor support interventions are started then.
15977440|NCT03056300|Device|Video-Assisted Thoracoscopic Lobectomy with powered vascular stapler|Powered Vascular Stapler used on vessels
15977441|NCT03056287|Behavioral|Aerobic exercise|treadmill aerobic exercise; 3 sessions per week, 40 minutes per session
15977442|NCT03056287|Other|Repetitive transcranial magnetic stimulation|Repeated non-invasive brain stimulation to the left dorsolateral prefrontal cortex.
15977443|NCT03056274|Drug|Metformin|Metformin Hydrochloride (HCl) Tablets, is an oral antihyperglycemic drug used in the management of type 2 diabetes
15977444|NCT03056274|Drug|Ursodeoxycholic Acid|Ursodeoxycholic acid (UDCA) is used to treat gallstones and primary biliary cirrhosis. UDCA is also used to treat obstetric cholestasis (OC), a liver condition that occurs specifically in pregnancy.
15977445|NCT03056261|Procedure|Combined general and epidural|Combined general and epidural anaesthesia
15977446|NCT03056261|Procedure|General anaesthesia|General anaesthesia
15977447|NCT03056248|Drug|Placebo oral capsule|On day 0, the day of the cardiac surgery placebo will be given once On day 1, one day after cardiac surgery placebo will be given once On day 2, two days after cardiac surgery placebo will be given once
15977448|NCT03056248|Drug|Lithium Carbonate|On day 0, the day of the cardiac surgery oral lithium will be given at dose 900mg once On day 1, one day after cardiac surgery oral lithium will be given at dose 900mg once On day 2, two days after cardiac surgery oral lithium will be given 900mg once
15977449|NCT03056235|Device|ELAPR002f|30mg/ml Tropoelastin cross-linked with derivatised hyaluronic acid
15977450|NCT03056235|Device|Saline|Saline control
15977451|NCT03056222|Device|Ablation catheter|Ablation of paroxysmal atrial fibrillation
15977452|NCT03056209|Drug|KL1333 25 mg|oral administration, single dose, 25 mg 1 tab
15977453|NCT03056209|Drug|KL1333 50 mg|oral administration, single dose, 25 mg 2 tabs
15977454|NCT03056209|Drug|KL1333 100 mg|oral administration, single dose, 100 mg 1 tab
15977455|NCT03056209|Drug|KL1333 200 mg|oral administration, single dose, 100 mg 2 tabs
15977456|NCT03056209|Drug|KL1333 400 mg|oral administration, single dose, 100 mg 4 tabs
15977457|NCT03056209|Drug|KL1333 600 mg|oral administration, single dose, 100 mg 6 tabs
15977458|NCT03056209|Drug|KL1333 800 mg|oral administration, single dose, 100 mg 8 tabs
15977459|NCT03056209|Drug|Placebo|oral administration, placebo
15977460|NCT03056196|Diagnostic Test|point of care ultrasound|want to assess the ability of d-dimer test and point of care ultrasound to role out lower leg DVT
15977461|NCT03056183|Behavioral|Depression Care Transitions (DCT)|DCT Intervention group - Patients in the DCT intervention will have a Transitional Care Social Worker (TCSW) who will maintain daily phone contact, home visits, and will attend with the patient medical and psychiatric appointments for an average of three months following discharge. Patients in the usual care group will proceed as usual (scheduled follow-up visits). These subjects will also be asked to complete questionnaires relating to quality of life and physical and mental health status.
15977462|NCT03056170|Device|real tDCS|"In active stimulation, the Transcranial Direct Current Stimulation device will produce a direct current of 1 mA from one electrode to the other for 30 min with a ramp up at the beginning and a ramp down at the end of the stimulation of 30 s. The sham or active mode is chosen by a numeric code."
15977463|NCT03056157|Behavioral|Adaptive Disclosure for Moral Injury and Loss|Ad-MIL is a 12-session treatment designed to address shame and guilt and to develop compassion for the self and the other. At the outset of AD-MIL, the investigators ask Veterans to enlist a family member or friend to provide support and to reinforce their plan for adaptive, purposeful functioning moving forward. The sessions that follow homework assignments involve a discussion to reinforce positive steps taken and identifying obstacles to completion (e.g., self-defeating beliefs). There is a special emphasis on discussing self-handicapping, namely feeling unworthy of getting better or living a good life. The goal is not only for Veterans to develop a sense of mastery in accomplishing tasks and to experience the benefits of the activities, but also to work on overcoming feelings of unworthiness.
15977464|NCT03056157|Behavioral|Present Centered Therapy|Participants randomized to the PCT arm will receive 12 sessions of therapy focused on problems occurring in the present (with no focus on trauma or re-visiting past experiences).
15977465|NCT03056144|Device|whole body vibration therapy|"The whole body vibration therapy regime is as follows:
~Day Vibration 1 Rest 1 Vibration 2 Rest 2 Vibration 3 Rest 3
~st 1 min;12Hz 3 min 1 min;12Hz 3 min 1 min;15Hz 3 min
~nd 1 min;15Hz 3 min 1 min;15Hz 3 min 2 min;15Hz 3 min
~th 2 min;15Hz 3 min 3 min;15Hz 3 min 3 min;15Hz 3 min
~th 2 min;24-25Hz 3 min 2 min;24-25Hz 3 min 2 min;24-25Hz 3 min >5th 3 min;24-25Hz 3 min 3 min;24-25Hz 3 min 3 min;24-25Hz 3 min
~The participants will perform mini-squats during Vibrations 1 and 3 and weight-shifting between right and left legs during Vibration 2 on the vibration platform under the supervision of a trained research assistant."
15977466|NCT03056131|Device|Diacutaneous Fibrolysis|Diacutaneous Fibrolysis is a non invasive physiotherapeutic technique applied by means a set of metallic hooks having the advantage of allowing a deeper and more precise application, which could not be achieved manually
15977467|NCT03056118|Drug|6-month dual anti-platelet therapy|Aspirin and P2Y12 inhibitor after percutaneous coronary intervention continues for 6 months
15977468|NCT03056118|Drug|12-month dual anti-platelet therapy|Aspirin and P2Y12 inhibitor after percutaneous coronary intervention continues for 12 months
15977469|NCT03056118|Device|Zotarolimus eluting stent|Zotarolimus eluting stent is applied to coronary stenotic lesion
15977470|NCT03056118|Device|Biolimus eluting stent|Biolimus eluting stent is applied to coronary stenotic lesion
15977471|NCT03056105|Other|Residential Insight Meditation Retreat|"Retreats at Spirit Rock Meditation Center were led by teams of 6 experienced teachers. Participants practiced noble silence-refraining from eye contact as well as verbal and written communication-except during meetings with teachers. Teachers lead guided Insight meditation practices, as well as meditations on loving-kindness, compassion, empathetic joy, and equanimity. The daily schedule consisted of sitting and walking meditation sessions (30-45 mins) totaling 8-10 hours/day, meals, and short work meditations (sweeping, dishes, etc.). Seated meditation was practiced as a group in a meditation hall with approximately 80 participants. Walking meditation took place in adjoining halls or on the grounds. Participants lived on-site during the retreat and were provided with a vegetarian diet."
15977472|NCT03056092|Drug|Intravitreal ranibizumab|Patients will be treated with intravitreal ranibizumab and have their aqueous humor obtained for cytokine analysis at every visit that an intravitreal injection is done
15977473|NCT03056079|Drug|Intravitreal aflibercept|Patients will receive intravitreal aflibercept on a variable dosing regimen and have aqueous humor sample obtained for cytokine analysis at every visit when an intravitreal injection is done.
15977474|NCT03056066|Device|Plethysmograph|A full Body Plethysmography examination
15977475|NCT03056053|Drug|Zolpidem|Commercially available tablets of zolpidem (5 or 10 mg) for oral use
15977519|NCT03055741|Drug|DHP1401|Total 500mg or 1,000mg was administrated in two divided doses a day for 24 weeks
15977520|NCT03055741|Drug|Placebo|Placebo was administrated in two divided dosed a day for 24 weeks
15977521|NCT03055728|Diagnostic Test|Rapid strep antigen detection test|Pharyngeal swab for rapid antigen detection of streptococcus
15977476|NCT03056040|Biological|Ravulizumab|All treatments were given as intravenous (IV) infusions. For participants weighing ≥40 to <60 kilograms (kg): 2400 mg was given as a single loading dose, followed by 3000 mg as maintenance dose. For participants weighing ≥60 to <100 kg: 2700 mg was given as a loading dose, followed by 3300 mg as maintenance dose. For participants weighing ≥100 kg: 3000 mg was given as a loading dose, followed by 3600 mg as maintenance dose.
15977477|NCT03056040|Biological|Eculizumab|All treatments were given as IV infusions. Participants received 900 mg of eculizumab q2w.
15977478|NCT03056027|Diagnostic Test|Ecocolordoppler ultrasound testicular evaluation|Ecocolordoppler ultrasound testicular evaluation
15977479|NCT03056014|Drug|N-acetyl cysteine|giving varying doses of NAC in order to determine which reduces oxidative stress.
15977480|NCT03056014|Dietary Supplement|omega 6 Fish oil ( PUFA)|giving varying doses of PUFA in order to determine which reduces oxidative stress.
15977481|NCT03056014|Dietary Supplement|Placebo|L-alanine placebo pill to determine if effect is supplement related or random effect.
15977482|NCT03056001|Drug|Pembrolizumab|IV infusion on day 1 of each 3 week cycle, at dose of 200 mg
15977483|NCT03056001|Drug|Doxorubicin|IV injection on day 1 of each 3 week cycle, starting at dose of 60 mg/m2 (may be escalated to 75 mg/m2 per investigator discretion after Cycle 1
15977484|NCT03055988|Drug|Tiotropium|Fixed Dose Combination
15977485|NCT03055988|Drug|Olodaterol|Fixed Dose Combination
15977486|NCT03055988|Drug|Fluticasone propionate|Fixed Dose Combination
15977487|NCT03055988|Drug|Salmeterol|Fixed Dose Combination
15977488|NCT03055975|Diagnostic Test|Detection of residual vital bacteria in the root canal space|Detection of residual vital bacteria in the root canal space. No intervention, as it is an observational study. Vital bacteria are looked for in the samples taken from the root canal space.
15977489|NCT03055962|Drug|E2609|tablet
15977490|NCT03055962|Drug|Placebo|tablet
15977491|NCT03055949|Behavioral|Early rehabilitation program|The investigators evaluated patients who were admitted SICU for more than 3 days for an early rehabilitation program and delivered one of 5-stepped rehabilitation program if the patient was eligible.
15977492|NCT03055936|Drug|Levodopa|Levodopa 50 mg or 100 mg or 150 mg
15977493|NCT03055936|Drug|Carbidopa|Carbidopa 12.5 mg or 25 mg or 65 mg
15977494|NCT03055936|Drug|ODM-104|ODM-104 50 mg or 100 mg
15977495|NCT03055923|Device|The Inflammacheck Device|A new hand-held, Non-invasive breathing test, that only requires tidal breathing.
15977496|NCT03055910|Diagnostic Test|Fractional Flow Reserve Measurement|Wire-based invasive measurement of the fractional flow reserve in the context of coronary angiography and percutaneous coronary intervention in order to assess the hemodynamic relevance of coronary artery stenoses
15977497|NCT03055897|Device|iLux 2020 System|Medical device that applies localized heat and pressure therapy to the eyelid in order to express melted meibum from obstructed glands
15977498|NCT03055884|Device|tDCS|active tDCS versus sham tDCS
15977499|NCT03055884|Behavioral|Verbal paired-associate learning task|with or without repeated retrieval practice
15977502|NCT03055858|Device|ADO II AS (PDA closure)|Closure of PDA using Amplatzer Duct Occluder II Additional Sizes (ADO II AS).
15977503|NCT03055845|Drug|STA363|STA363, containing 3 different doses of active ingredient, in a volume of 1.5 mL. Administered as intradiscal injection.
15977504|NCT03055845|Drug|Placebo|Matching placebo solution with identical appearance to the test product, used as reference treatment. Administered as intradiscal injection.
15977505|NCT03055832|Device|iLux 2020 System|Medical device that applies localized heat and pressure therapy to the eyelid in order to express melted meibum from obstructed glands
15977506|NCT03055832|Device|LipiFlow Pulsation System|Medical device that applies a combination of heat and pressure to the inner eyelid to remove gland obstructions and stagnant gland content
15977507|NCT03055819|Device|Brow Lift|Minimally Invasive Brow Lift
15977508|NCT03055806|Drug|IX-01 400 mg|IX-01 400 mg caplet
15977509|NCT03055806|Drug|Placebo|Placebo caplet(s)
15977510|NCT03055806|Drug|IX-01 800 mg|IX-01 800 mg (Two 400 mg caplets)
15977511|NCT03055806|Drug|IX-01 1200 mg|IX-01 1200 mg (Three 400 mg caplets)
15977512|NCT03055793|Other|budesonide formoterol fixed combination|Asthmatic patients who will be on budesonide formoterol fixed combination treatment administered by Elpenhaler device.
15977513|NCT03055780|Device|CT-FFR. CTA. FFR|Study is to compare results of CT FFR against CTA and interventional FFR
15977514|NCT03055767|Drug|OnabotulinumtoxinA|The AB subject group will receive OnabotulinumtoxinA in the first treatment and saline placebo in the second.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope.
15977515|NCT03055767|Other|Placebo (Saline)|The BA subject group will receive saline and then Onabotulinumtoxin. A.Both groups will then receive OnabotulinumtoxinA in the last two treatments. There will be one treatment at the beginning of each 12 week block, meaning 4 treatments over the 48 week study period total. Progress check-ups will occur every 6 weeks during the study. Randomization will be via selection of sealed envelope.
15977516|NCT03055754|Procedure|Argon randomized arm|Endoscopic argon plasma coagulation
15977522|NCT03055728|Diagnostic Test|throat culture|Pharyngeal swab for culture for bacteria (specifically streptococcus) presence
15977523|NCT03055702|Other|Mobile phone text message reminder|an SMS remind subjects to come for scheduled clinic appointment 24-72 hours before
15977524|NCT03055689|Behavioral|Educational telephone intervention|Subjects will receive a nurse-led educational telephone intervention for bowel preparation 24-48 hours before the colonoscopy
15977525|NCT03055689|Behavioral|Standard education for colonoscopy|Standard education for bowel preparation at the time of colonoscopy scheduling
15977526|NCT03055676|Other|Early drain removal|Removing drain(s) on postoperative day 3
15977527|NCT03055676|Other|Late drain removal|Removing drain(s) on postoperative day 5 or later
15977528|NCT03055663|Other|Sedation by watching virtual reality sedative program|Patients watch three-dimensional virtual reality program with headset and headphone during surgery.
15977529|NCT03055663|Procedure|Sedation by using intravenous sedative|Patients receive intravenous sedative (midazolam 1-2 mg bolus with 1 mg maintenance dose every 10- 30 minutes)
15977530|NCT03055663|Drug|Midazolam|Patients receive intravenous sedative (midazolam 1-2 mg bolus with 1 mg maintenance dose every 10- 30 minutes)
15977531|NCT03055650|Device|iLux 2020 System|Medical device that applies localized heat and pressure therapy to the eyelid in order to express melted meibum from obstructed glands
15977532|NCT03055637|Procedure|Furlow double opposing z-plasty|* Furlow, (1986) has described a technique for palatoplasty combining the principles of mucosal lengthening with creation of an intact muscular sling in the palate with double opposing Z-plasty. On the soft palate, mirror image Z-plasties are drawn, one for the nasal musoca and the other oral flaps, the nasal flaps are developed and closed first .The oral flaps are then approximated. The defect created usually closes readily. The closure lines of the two soft plate layers do not overlap, minimizing the potential for contracture. Also, this repair permits closure of the hard palate without lateral incisions
15977533|NCT03055637|Procedure|Two flap palatoplasty|design the 2-flap palatoplasty, with a 2-layer closure in the hard palate and 3-layer closure in the soft palate,
15977534|NCT03055624|Device|Embosphere microparticles for prostate artery embolization|Pelvic angiograms will be performed and microspheres delivered to the arteries supplying the prostate to alleviate symptoms of benign prostatic hyperplasia.
15977535|NCT03055611|Drug|ELOCTA|Extended half-life factor VIII product
15977536|NCT03055611|Drug|ALPROLIX|Extended half-life factor IX product
15977537|NCT03055598|Drug|Ferric Citrate|Doses can be adjusted as needed by 1 to 2 tablets up to a maximum of 12 tablets daily. Dose can be titrated at 1-week or longer intervals.
15977538|NCT03055585|Biological|Wolbachia-infected Aedes aegypti mosquitoes|Deployment of Wolbachia-infected Aedes aegypti mosquitoes
15977539|NCT03055585|Other|standard practice dengue control|standard practice dengue control activities conducted by dengue control program
15977540|NCT03055572|Other|Olfactory Training with Essential Oils|Participants will be instructed to sniff one of four provided odors for approximately 10 seconds followed by a 10 second break before repeating with each successive odor for a total of 5 minutes. Essential oils will be used for the odors. The intervention will be completed in the morning before breakfast and in the evening before bed. Participants will document compliance by completing a log of olfactory training sessions.
15977541|NCT03055572|Other|Olfactory Training with Pure Fragrance Oils|Participants will be instructed to sniff one of four provided odors for approximately 10 seconds followed by a 10 second break before repeating with each successive odor for a total of 5 minutes. Pure fragrance oils will be used for the odors. The intervention will be completed in the morning before breakfast and in the evening before bed. Participants will document compliance by completing a log of olfactory training sessions.
15977542|NCT03055559|Dietary Supplement|Globifer Forte|
15977543|NCT03055546|Drug|Oxytocin|intranasal administration of oxytocin
15977544|NCT03055546|Drug|Placebo|intranasal administration of placebo
15977545|NCT03055533|Behavioral|Headsprout reading program|Headsprout is a commercially available, computer-based program reading intervention that can be tailored to meet the individual needs of each child. Participants will have treatment sessions with a trained therapist lasting one to two hours, two to four days a week, for approximately twelve weeks.
15977546|NCT03055520|Other|cognitive training|The Kumon method (www.kumon.com) of arithmetic calculation employs the errorless-learning (EL) strategy and consists of a structured, hierarchical series of exercises, beginning with simple ones (e.g. addition and subtraction) and then proceeding to more complex exercises (e.g. advanced algebra, calculus).
15977547|NCT03055520|Other|placebo|nonspecific recreation including befriending and free simple activities.
15977548|NCT03055507|Drug|Ibuprofen 400 mg|Addition of ibuprofen to standard pain regimen.
15977549|NCT03055507|Drug|Acetaminophen 650 mg|Standard analgesic provided post-operatively to patients undergoing sinus surgery
15977550|NCT03055507|Drug|OxyCODONE 5 Mg Oral Tablet|Standard PRN medication offered post-operatively for breakthrough pain
15977551|NCT03055494|Biological|Secukinumab|Secukinumab 300 mg s.c. at randomization, Weeks 1, 2, 3, and 4 was followed by monthly dosing up to Week 48
15977552|NCT03055494|Biological|Placebo|Placebo s.c. at randomization, Weeks 1, 2, 3, 4, and 8; secukinumab 300 mg s.c. at Weeks 12, 13, 14, 15, and 16 followed by monthly dosing up to Week 48
15977553|NCT03055481|Other|High irradiance level of phototherapy|High irradiance level of phototherapy: the target irradiance level is 30-35uW per square centimeter per nanometer of wavelength.
15977554|NCT03055481|Other|Low irradiance level of phototherapy|Low irradiance level of phototherapy: the target irradiance level is 12-15uW per square centimeter per nanometer of wavelength
15977555|NCT03055468|Behavioral|Peer support|Peer support and antidepressant medications
15977556|NCT03055455|Diagnostic Test|MR imaging|Conventional structural imaging will be combined with advanced neuroimaging modalities to evaluate integrity of white matter tracts, regional brain perfusion, and the 3-dimensional volume of specific brain structures.
15977557|NCT03055442|Other|Dosage of myo-inositol|Quantitative analysis of myo-inositol was performed by gas chromatography-mass spectrometry (GC-MS)
15977558|NCT03055442|Other|Dosage of D-chiro-inositol|Quantitative analysis of D-chiro-inositol was performed by gas chromatography-mass spectrometry (GC-MS)
15977559|NCT03055429|Other|Full Scale Unit|Pre-test, usability, post-test
15977561|NCT03055403|Drug|M201-A Injection|Active Substance: M201-A Route of administration: continuous intravenous injection
15977562|NCT03055403|Drug|Placebo|Saline Placebo for M201-A Route of administration: continuous intravenous injection
15977563|NCT03055390|Drug|hyoscine butylbromide|Intravenous administration of hyoscine butylbromide during first stage of labor
15977564|NCT03055390|Drug|placebo|2ml of saline intravenous
15977565|NCT03055377|Drug|N-acetyl cysteine|N-acetylcysteine 1200 mg twice daily for 12 weeks (administered orally)
15977566|NCT03055377|Drug|Placebo oral capsule|Placebo (matched in appearance to N-acetylcysteine to preserve double-blind) twice daily for 12 weeks (administered orally)
15977567|NCT03055351|Behavioral|Stop&Go Intervention|Stop&Go intervention will be based on Self-determination theory. Patients will participate in four practically-oriented training sessions, focused on (1) nutrition and oral hygiene, (2) sleep habits and self-care, (3) physical activity and exercise, and (4) smoking cessation. In addition, the entire inpatient detoxification centre will be adapted to encourage autonomous physical activity and to reinforce the ideas presented in the training sessions.
15977568|NCT03055338|Drug|MK-8189|Oral CR tablets (4 mg) administered QD at the following dose strengths: 4 mg (1 tablet); 8 mg (2 tablets); 12 mg (3 tablets)
15977569|NCT03055338|Drug|Risperidone|Oral capsules (2 mg) administered QD at the following dose strengths: 2 mg (1 capsule); 4 mg (2 capsules); 6 mg (3 capsules)
15977570|NCT03055338|Drug|Placebo matching MK-8189|Oral placebo tablet(s) matching the MK-8189 tablet, administered QD.
15977571|NCT03055338|Drug|Placebo matching risperidone|Oral placebo capsule(s) matching the risperidone capsule, administered QD.
15977572|NCT03055325|Other|Observational study of patients undergoing surgery|Cognitive testing, testing of heart rate variability and collection of blood samples
15977573|NCT03055312|Drug|TPC|"Conventional chemotherapy(choose a):
~TX:(Docetaxel 75mg/m2 iv day1 and Capecitabine 950mg/m2 po twice daily days 1-14)every 3 weeks.
~GT:(Paclitaxel 175mg/m2 iv day1 and Gemcitabine 1250mg/m2 iv days 1 & days 8)every 3 weeks.
~GC:(Gemcitabine 1000mg/m2 on days 1 & days 8 and Carboplatin by Area Under Curve (AUC) 2 iv on days 1 & days 8) every 3 weeks"
15977574|NCT03055312|Drug|Bicalutamide 150 mg|Bicalutamide 150mg/day,every 28 days
15977575|NCT03055299|Other|COMEX intervention|Comprehensive Exercise
15977576|NCT03055286|Drug|CWP232291|"For cohort 1-3, a fixed dose of ara-C at 1 G/m2 will be administered IV over 2 hours daily from Day 1 to Day 5 following CWP232291 infusion.
~For cohort 4, a fixed dose of ara-C at 1 G/m2 will be administered IV over 2 hours daily from Day 1 to Day 7 following 250 mg/m2 CWP232291 infusion."
15977577|NCT03055273|Behavioral|SOCIABLE|SOCIABLE services involve a nurse, and occupational therapist and a handyman to support function among older adults with end stage renal disease. There is particular emphasis on supporting the social function and the physical and everyday living function.
15977578|NCT03055260|Device|Blood flow restriction cuff|The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.
15977579|NCT03055260|Device|Blood Flow restriction Cuff-Placebo|The intervention is the wearing of a cuff-like band around the affected limb, of which partially restricts blood flow to the limb.
15977580|NCT03055247|Drug|Ibuprofen|Ibuprofen: 3 mg/kg tid (total daily dose: 9 mg/kg); administered orally from day 1 to day 5 and then from day 14 to the day before the last LP.
15977581|NCT03055247|Drug|Myelostim|Myelostim (G-CSF): 5 µg/kg bid (total daily dose 10 µg/kg); administered subcutaneously from day 19 to the day of the last LP.
15977582|NCT03055247|Drug|Mozobil|Mozobil (Plerixafor): 0,24 mg/kg daily. When CD34+ are ≥ 10 /μL Plerixafor will be administered subcutaneously from the next day (or from day 24 if CD34+ are < 10 /μL) to the day of the last LP.
15977583|NCT03055234|Drug|Oral Treprostinil|Extended-release oral tablet for TID administration
15977584|NCT03055234|Drug|Placebo|Matching placebo for TID administration
15977585|NCT03055221|Drug|Intravenous Treprostinil|Intravenous treprostinil supplied in 20-mL vials and diluted to the appropriate concentration for administration.
15977586|NCT03055208|Radiation|gamma knife radiosurgery (15 Gy to 50% isodose)|Radiosurgery with a gamma knife resembles the application of a precisely focused, high single dose of ionizing irradiation.
15977587|NCT03055195|Drug|Mepolizumab 100 mg|Mepolizumab is available as lyophilized powder in sterile vials for injection. The content is reconstituted with 1.2 milliliter (mL) Sterile Water just prior to use. Subjects will receive 1mL (100 mg/mL) bolus subcutaneous injections.
15977588|NCT03055195|Drug|Placebo matching mepolizumab|Placebo is available as 0.9% sodium chloride solution. Subjects will receive 1mL bolus subcutaneous injections.
15977589|NCT03055182|Other|Physical rehabilitation program|Patients participate during 4 weeks to a physical rehabilitation program.
15977590|NCT03055169|Genetic|genetic analysis|
15977591|NCT03055169|Biological|blood and stools samples|
15977592|NCT03055156|Device|Low rebound mattress toppers|Patients will sleep on this mattress topper during their diagnostic sleep study.
15977593|NCT03055156|Device|High rebound mattress toppers|Patients will sleep on this mattress topper during their diagnostic sleep study.
15977594|NCT03055143|Drug|SPARC-08-038|2 mg/ml intravenous infusion
15977595|NCT03055143|Drug|Ref-08-038|2 mg/ml intravenous infusion
15977596|NCT03055130|Other|Thinprep Cytology Test (TCT) and HPV infection types were tested by gynecologist|
15977597|NCT03055117|Behavioral|Group-based exercise rehabilitation|Group- based physiotherapy-led exercise rehabilitation
15977598|NCT03055117|Behavioral|Individual exercise rehabilitation|Individual physiotherapy-led exercise rehabilitation
15977599|NCT03055117|Behavioral|Home exercise|Supervised home exercise
15977600|NCT03055104|Other|management of severe malnutrition|multidisciplinary assessment; guideline for the management of severe malnutrition in PUTH
15977601|NCT03055091|Other|Xylitol syrup|Each dose will be 5 mL of 400 g/L and subjects will receive Three to 5 doses will be given each day.
15977602|NCT03055091|Other|Placebo|Each dose looks and tastes like the xylitol syrup but it is not microbial. Each dose will be 5 mL of 300 g/L of sorbitol. Three to 5 doses will be given each day.
15977737|NCT03054103|Drug|Midazolam + Ketamine 10 MG/ML: 1 ML|10 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case.
15977603|NCT03055078|Biological|mesenchymal stem cells|Patients in the cell treated group were given umbilical cord derived mesenchymal stem cells by intravenous infusion besides conventional therapy. There was only conventional treatment in the control group. All patients after treatment for 1months, 3months, 6months and 9months were evaluated respectively the therapeutic effect.
15977604|NCT03055052|Other|Standard formula for preterm infants|Reconstituted in water and given to infants at more than 50% of feedings.
15977605|NCT03055052|Other|Formula with higher protein and new fat blend for preterm infants|Reconstituted in water and given to infants at more than 50% of feedings.
15977606|NCT03055026|Drug|Rivaroxaban|Tablets
15977607|NCT03055026|Drug|Placebo|Tablets
15977613|NCT03055000|Biological|AGS-v|AGS-v (unadjuvanted) as a suspension in WFI (0.5mL) on Day 0 and on Day 21
15977614|NCT03055000|Biological|AGS-v + adjuvant|ISA-51-adjuvanted AGS-v emulsified in WFI (0.5mL) on Day 0 and on Day 21
15977615|NCT03055000|Other|Placebo|WFI (0.5mL) on Day 0 and Day 21
15977616|NCT03054987|Procedure|EUS-BD|EUS-BD is a minimally invasive technique where the common bile duct (choledochoduodenostomy) is punctured under EUS-guidance and after transmural dilation, a stent is deployed for biliary drainage.
15977617|NCT03054987|Procedure|ERCP|During the ERCP, a small catheter and guidewire is inserted into the bile duct and the stent can be deployed into the duct.
15977618|NCT03054974|Other|Modern rehabilitation treatment|PT 1 hour per day and OT 30min per day
15977619|NCT03054974|Other|Modern rehabilitation &TCM|Traditional Chinese Medicine, including massage and medicated bath
15977620|NCT03054974|Other|modern rehabilitation &Baimai Ruangao|modern rehabilitation treatment with Baimai Ruangao and massage
15977621|NCT03054974|Other|modern rehabilitation &Tibetan medicine|modern rehabilitation treatment and Tibetan medicine(medicated bath with wuweiganlu and rub with baimairuangao)
15977622|NCT03054961|Device|Near-infrared spectroscopy|Measurement of CCO redox state and cerebral oxygenation during epileptic seizures.
15977623|NCT03054948|Drug|SMOFLipid|SMOFlipid is a lipid emulsion formed using soybean oil, medium chain triglycerides, olive oil, and fish oil.
15977624|NCT03054948|Drug|Standard therapy|In most cases standard therapy will be IntraLipid.
15977625|NCT03054935|Other|Indirect Calorimetry|Measurement of resting energy expenditure
15977626|NCT03054922|Drug|Normal Saline|IV infusion of 0.9% NaCl throughout surgery.
15977627|NCT03054922|Drug|Lactated Ringer|IV infusion of lactated ringer throughout surgery.
15977628|NCT03054922|Drug|Normosol-R Inj|IV infusion of Normosol throughout surgery.
15977629|NCT03054909|Biological|ALT-803 Subcutaneous|Patient receives ALT-803 10 mcg/kg subcutaneous weekly x 4 followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off)
15977630|NCT03054909|Biological|ALT-803 Intraperitoneal|Patient receives ALT-803 10 mcg/kg intraperitoneal weekly x 4 weeks followed by 4 weeks of no treatment before continuing with treatment courses 2, 3, and 4. Treatment courses 2, 3, and 4 are identical for all patients - ALT-803 10 mcg/kg subcutaneous weekly x 4 with a 4 week rest (4 weeks on/4 weeks off).
15977631|NCT03054896|Drug|Venetoclax|Venetoclax is an Antineoplastic Agent; BCL-2 Inhibitor
15977632|NCT03054896|Other|DA-EPOCH-R|Intensive chemotherapy regiment
15977633|NCT03054896|Other|R-CHOP|Intensive chemotherapy regiment
15977634|NCT03054870|Drug|Xe-133|Xe-133 ventilation scintigraphy
15977635|NCT03054870|Drug|Technegas|Technegas ventilation scintigraphy
15977636|NCT03054857|Drug|Dexmedetomidine|After skin incision, the dexmedetomidine group received a loading dose of 0.5 mcg/kg of Dexmedetomidine in 20 minutes followed by a continuous IV infusion at 0.4 mcg/kg/hr until the end of operation.
15977637|NCT03054857|Drug|Placebo|The control group received a loading dose and continuous IV infusion of normal saline at the same volume and rate as in the dexmedetomidine group
15977638|NCT03054844|Drug|Lidocaine|Lidocaine will be administered before administration of midazolam.
15977639|NCT03054844|Drug|Lidocaine and midazolam (PREMIX)|Lidocaine will be administered as a mixture with midazolam.
15977640|NCT03054844|Drug|Midazolam|Midazolam will be administered either after lidocaine, or as a mixture with lidocaine.
15977641|NCT03054831|Drug|liquid oxycodone|"The group will include 25 patients (children 2-5 years old). In this group the children will be randomized to receive 0.1mg/kg of liquid oxycodone via an orogastric tube before the procedure at the beginning of general anesthesia (after intubation).
~In this group 25 children will be randomized to receive 0.1mg/kg of liquid oxycodone via an orogastric tube after the procedure at the end of general anesthesia (before extubation).
~The group will include 25 patients (children 6-8 years old). In this group the children will be randomize to receive 0.1 mg/kg of liquid oxycodone orally before the surgery in pre-op holding.
~The group will include 25 patients (children 6-8 years old). In this group the children will be randomize to receive 0.1 mg/kg of liquid oxycodone orally after surgery in the Post Anesthesia Care Unit (PACU)."
15977642|NCT03054805|Drug|Magnesium Oxide|Magnesium oxide 250 mg per day for children with weight < 15 kg, 500 mg per day for weight <15-30 kg, and 1000 mg per day for weight > 30 kg
15977643|NCT03054805|Drug|MIYAIRI-BM|MIYAIRI-BM 1 g (1package) per day for children with weight < 15 kg, 2g per day for weight 15-30 kg, and 3g per day for weight > 30 kg
15977644|NCT03054792|Drug|18F-FAZA (F18-Fluoroazomycin Arabinoside)|Intravenous administration of a hypoxia marker, 18F- Fluoroazomycin arabinoside (FAZA), before a PET-MR imaging in order to identify areas of lower oxygen content on samples of a tumour.
15977645|NCT03054792|Diagnostic Test|Blood Oxygen Level Dependent [BOLD] MRI|BOLD is a non-invasive T2*-weighted MRI technique that is sensitive to the microvascular deoxyhemoglobin concentration. BOLD has the potential to monitor changes in tissue oxygenation in response to a gas breathing challenge to induce contrast.
15977738|NCT03054103|Drug|Midazolam + Normal saline|Preoperative control: Normal saline placebo given preoperatively. Then protocol followed for titration of midazolam up to 2 mg IV at beginning and during case.
15977646|NCT03054792|Diagnostic Test|Diffusion-Weighted [DW] MRI|DW MRI is a non-invasive technique that provides quantitative biophysical information about the movement of water in tissues and reflects the anisotropy of normal and pathologic cells
15977647|NCT03054792|Diagnostic Test|Magnetic Resonance Spectroscopy [MRS]|MRS is a non-invasive imaging technique that enables the generation of spectral profiles of low molecular weight metabolites that reflect status of a tissue
15977648|NCT03054779|Other|Canola Oil|Regular canola oil will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily.
15977649|NCT03054779|Other|High oleic acid canola oil|High oleic acid canola oil will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily.
15977650|NCT03054779|Other|Western diet oil combination|"A typical Western diet fat intake as a control treatment, comprised of 11% MUFA, 11% PUFA (9% omega-6 fatty acids and 2% omega-3 fatty acids), and 13% SFA, will be iso-calorically incorporated into fruit smoothies made with milk and consumed twice daily"
15977651|NCT03054766|Procedure|Ranibizumab combined macular laser|subjects in one group receive both macular laser photocoagulation and ranibizumab injections but ones in the other group just received ranibizumab injection.
15977652|NCT03054766|Drug|Ranibizumab|all subjections received 3+PRN ranibizumab injections by BCVA stabilization
15977653|NCT03054753|Behavioral|Abduction brace wearing time analysis|To evaluate the patient´s abduction brace wearing time a sensor = Orthotimer® (Rollerwerk, 72336 Balingen, Germany, www.orthotimer.com) is implanted in the abduction brace. The sensor measures the body temperature of the patient. Through that the wearing time can be evaluated.
15977654|NCT03054740|Drug|Gebauer Ethyl Chloride|Will be administered according to manufacturers recommendations which is to spray the aerosol can for 4-10 seconds from a distance of 3 to 9 inches. Do not spray longer than 10 seconds.
15977655|NCT03054740|Drug|Nature's Tears|Sterile water mist will be administered 1-2 sprays prior to intravenous access
15977656|NCT03054727|Other|Villalta phone score > or = to 5|"Follow up call. At the end of the follow-up, the patients who received an Utne and Sandset Villalta phone score > or = 5 will have a visit with clinical and CUS assessments of PTS/ venous insufficiency.
~All patients will have self administered-questionnaires. For Grenoble Center, the 200 first patients with clinical follow-up will have an Echo-Doppler examination."
15977657|NCT03054727|Other|Villalta phone score < 5|"Follow up call. At the end of the follow-up, the patients who received an Utne and Sandset Villalta phone score < 5, will don't have a clinical follow up.
~All patients will have self administered-questionnaires."
15977658|NCT03054714|Device|catheter replacement|catheter removal and delayed replacement, versus exchange over a guidewire
15977659|NCT03054701|Other|Hip specific resistance exercise|Hip specific resistance exercise
15977660|NCT03054701|Other|Knee specific resistance exercise|Knee specific resistance exercise
15977661|NCT03054688|Device|Somnotouch NIBP|Somnotouch NIBP in addition to standard blood pressure measurement
15977662|NCT03054675|Diagnostic Test|Spirometry|Absolute FEV1 is measured in every patient using a handheld spirometer
15977663|NCT03054662|Other|Education|Education of patients and caregivers about haemophilia and carriers of haemophilia.
15977664|NCT03054662|Diagnostic Test|Improve biological diagnosis and follow-up of haemophilia|train the laboratory to the diagnosis ans follow-up un haemophilia
15977665|NCT03054662|Drug|Implement haemostatic non substitutive care of haemophilia|Implement the use of DDAVP and antifibrinolytics in patients with haemophilia and symptomatic carriers
15977666|NCT03054662|Other|Implement non haemostatic care of haemophilia|Implement regular physiotherapy, develop dental care, promote the regular use of pain killers
15977667|NCT03054649|Device|HARMONI® Modular Intraocular Lens System|Two-component system consisting of a base and a separate optic that allows for an intraoperative exchange of the optic only without direct manipulation of the capsular bag
15977668|NCT03054649|Procedure|Intraoperative optic exchange|Removal of one optic and replacement with another during cataract surgery for the purpose of improving refractive outcomes
15977669|NCT03054623|Procedure|DRIL procedure|The DRIL procedure involves creation of a bypass from an arterial inflow site (usually mid brachial artery) proximal to the fistula inflow, to the bifurcation of the brachial artery distal to the fistula, with ligation of the intervening native vessel, thus restoring distal flow while preserving flow through the fistula.
15977670|NCT03054610|Drug|Betamethason Sodium Phosphate|
15977671|NCT03054610|Drug|Ropivacaine|
15977672|NCT03054610|Drug|Botulinum Toxins, Type A|
15977673|NCT03054597|Device|Circular light motion|Exercise with circular light motion
15977674|NCT03054597|Device|Diagonal light motion|Exercise with diagonal light motion
15977675|NCT03054597|Device|Peripheral light motion|Exercise with peripheral light motion
15977676|NCT03054597|Procedure|Exercise|
15977677|NCT03054584|Other|Collecting Nevi|Will be collecting Nevi and completing a DNA analysis, no intervention will be made.
15977678|NCT03054558|Other|Pelvic ultrasound both two dimensional and three dimentional|
15977679|NCT03054545|Drug|Iguratimod|Iguratimod 25mg twice a day, oral administrated.
15977680|NCT03054532|Drug|Durvalumab|Durvalumab intravenous 1500 mg
15977681|NCT03054532|Drug|Lenali|Lenalidomide oral 20 mg/day
15977682|NCT03054519|Drug|Metformin|Participants will be prescribed up to 2,000 mgs daily of metformin
15977683|NCT03054519|Drug|Placebo|Placebo pills will appear identical to the metformin to maintain blinding of participants and investigators.
15977684|NCT03054506|Device|CSP01|Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
15977685|NCT03054506|Device|Carboxymethylcellulose (CMC)|Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
15977686|NCT03054506|Device|Placebo|Subjects will take three capsules in the morning before breakfast, and three capsules at night before dinner each day for three weeks.
15977687|NCT03054493|Behavioral|no intervention|no intervention
15977688|NCT03054480|Device|Fractional Micro-Needle Radiofrequency|
15977689|NCT03054480|Drug|Botulinum toxin type A|
15978074|NCT03051282|Drug|Enalapril|Study participants in both arms will be treated with 10 mg enalapril orally once daily for seven consecutive days
15977690|NCT03054467|Drug|Caduet 10Mg-20Mg Tablet|Patients are randomly assigned to receive either amlodipine therapy (NORVASC 10 mg/day) or amlodipine/atorvastatin combination (CADUET 10/20mg) for 6 months. The starting dose of the drung is either 5mg amlodipine or 5/20mg CADUET. After 4 weeks, if the 5mg amlodipine is well tolerated, the dose is titrated to 10mg and 10/20mg CADUET
15977691|NCT03054467|Drug|NorvasC® 10 mg Tablets|Patients are randomly assigned to receive either amlodipine therapy (NORVASC 10 mg/day) or amlodipine/atorvastatin combination (CADUET 10/20mg) for 6 months. The starting dose of the drung is either 5mg amlodipine or 5/20mg CADUET. After 4 weeks, if the 5mg amlodipine is well tolerated, the dose is titrated to 10mg and 10/20mg CADUET
15977692|NCT03054454|Procedure|Podiatry|Podiatry treatments and care from the multidisciplinary team.
15977693|NCT03054441|Other|Actigraph|Actigraphs worn on wrists
15977694|NCT03054428|Drug|Dupilumab|Subcutaneous injection among the different quadrants of the abdomen (avoiding navel and waist areas), upper thighs, and upper arms.
15977695|NCT03054428|Drug|Placebo|Subcutaneous injection among the different quadrants of the abdomen (avoiding navel and waist areas), upper thighs, and upper arms.
15977696|NCT03054415|Procedure|endoscopy|colonic biopsies during endoscopy and anal manometry with barostat and anal endoflip
15977697|NCT03054402|Drug|BAY1834845|Escalating doses of BAY1834845 including comparison of solution and tablet in one dose group
15977698|NCT03054402|Drug|Placebo|Single dose of placebo
15977699|NCT03054389|Other|Qualitative Interview - Participants/ Patients|Qualitative interviews to understand the patient experience with the AskBio009-101 Study - Participants/ Patients
15977700|NCT03054389|Other|Qualitative Interview - Investigators and Study Coordinators|Qualitative interviews to understand the patient experience with the AskBio009-101 Study - Investigators and Study Coordinators
15977704|NCT03054363|Drug|Tucatinib in Combination with Palbociclib and Letrozole|"Starting dose of combination therapy :
~Tucatinib 300 mg PO BID Palbociclib 125 mg PO daily 21 day on, 7 days off Letrozole 2.5 mg PO daily
~Dose modifications, if necessary:
~If Palbociclib toxicity increased:
~Tucatinib 300 mg PO BID Palbociclib 100 mg PO daily 21 day on, 7 days off Letrozole 2.5 mg PO daily
~If Tucatinib toxicity increased:
~Tucatinib 250 mg PO BID Palbociclib 125 mg PO daily 21 day on, 7 days off Letrozole 2.5 mg PO daily
~If Palbociclib and Tucatinib toxicity increased:
~Tucatinib 250 mg PO BID Palbociclib 100 mg PO daily 21 day on, 7 days off Letrozole 2.5 mg PO daily
~Additional dose levels per protocol if PKs indicate a significant change to the metabolism of Tucatinib regardless of clinical toxicity."
15977705|NCT03054350|Drug|Vadadustat|Daily oral dose
15977706|NCT03054350|Drug|Placebo|Daily oral dose
15977707|NCT03054337|Drug|Vadadustat|
15977708|NCT03054337|Drug|Placebo|
15977709|NCT03054324|Diagnostic Test|Fractional Flow Reserve|Coronary fraction flow reserve (FFR), the ratio of the mean coronary pressure distal to a coronary stenosis to the mean aortic pressure during maximal coronary blood flow (hyperemia), defines the hemodynamic significance of coronary artery narrowing.
15977710|NCT03054311|Behavioral|Lifestyle Matters|
15977711|NCT03054298|Biological|huCART-meso cells|Intravenous administration or local delivery of lentiviral transduced huCART-meso cells in 7 cohorts with or without lymphodepletion..
15977712|NCT03054285|Drug|Levetiracetam|Participants assigned to the experimental arm will receive a seven day course of levetiracetam for post-traumatic brain injury
15977713|NCT03054272|Behavioral|Video|A 13-minute video based on a suggested CICO algorithm from the Difficult Airway Society that was produced at the University of Montreal Simulation Centre using high-fidelity settings.
15977714|NCT03054259|Drug|Rituximab|1000mg rituximab infusions on days 1 and 15 (monoclonal antibody)
15977715|NCT03054259|Drug|Methylprednisolone|100mg infusion on days 1 and 15
15977716|NCT03054259|Drug|Normal Saline|250ml infusion on days 1 and 15
15977717|NCT03054246|Other|Evaluation of chewing side preference|"The visual analog scale (VAS) is used. The individual will be asked to make 1 mark on a 10-cm line with  always left and always right at either end and with  no preference in the middle."
15977718|NCT03054233|Procedure|Crossed leg sitting position|Spinal anesthesia done in crossed leg sitting position
15977719|NCT03054220|Drug|Dextromethorphan 5 MG|
15977720|NCT03054220|Drug|Tramadol 10 mg|
15977721|NCT03054220|Drug|Duloxetine 60mg|
15977722|NCT03054220|Drug|Paroxetine 20 mg|
15977723|NCT03054207|Drug|Clopidogrel 300Mg Tablet|
15977724|NCT03054207|Drug|Prasugrel 60Mg|
15977725|NCT03054194|Drug|E2730|capsules
15977726|NCT03054194|Drug|Placebo|capsules
15977727|NCT03054181|Biological|HyQvia|
15977728|NCT03054168|Drug|Sustanon 250|The frequency of the injection will be every 2 weeks, 250mg of testosterone, intramuscular injection.
15977729|NCT03054168|Drug|Zoladex|The frequency of the injection will be just one injection, 3.6 mg of Zoladex, Subcutaneous injection (abdomen).
15977730|NCT03054168|Other|Placebo|
15977731|NCT03054155|Device|Alexandrite Laser|Alexandrite 755nm hair removal laser
15977732|NCT03054142|Other|no intervention|
15977733|NCT03054129|Other|Rehabilitation and balance training|"Stretching will be applied as hold-relax technique in PNF for shoulder flexion, abduction, internal and external rotations. Isotonic exercises will be done with elastic bands for strengthening.
~Home exercises will include postural, stretching and strengthening exercises. Balance exercises will receive as non-supervised program."
15977734|NCT03054129|Other|Rehabilitation program|Rehabilitation program will be same in this group except balance exercises.
15977735|NCT03054116|Diagnostic Test|Airflow pertubation device|Participants have airway resistance measured at the mouth by tidal breathing into a mouth-piece connected to the airflow perturbation device.
15977736|NCT03054103|Drug|Midazolam + Ketamine 10 MG/ML: 0.5 ML|5 mg ketamine IV given just prior to onset of case. Then titrated midazolam up to 2 mg IV at beginning and during case.
15978191|NCT03050359|Drug|TAK-438 Placebo|TAK-438 placebo-matching tablets.
15977739|NCT03054090|Other|Quality Improvement Support|Practices will receive a blended strategy of quality improvement facilitation to help participating practices incorporate PCOR clinical and organizational findings while building their overall practice capabilities. Primary care practices will be provided tools and training to improve the rates of screening and treatment of risk factors for heart attacks and strokes, as well as other chronic illnesses and the delivery of preventive services.
15977740|NCT03054077|Other|iPad with downloaded games|iPad with downloaded games will be given to children randomized to group 2 for use during their time in the peri-operative unit
15977741|NCT03054064|Device|Indego Exoskeleton|Six study sessions including five Indego training sessions over two weeks.
15977742|NCT03054051|Behavioral|Tumaini Mobile Phone Game|Tumaini is a scenario-based role-playing game application, optimized for use on low-cost Android smartphones. Participants will be invited to play the game for at least ten hours over a period of three weeks. The game is designed to: educate players about sexual health and HIV/AIDS; build risk-reduction skills and related self-efficacy for prevention of HIV/STIs and unintended pregnancy; challenge HIV stigma and harmful gender norms; and promote parent-child dialogue.
15977743|NCT03054038|Drug|Afatinib|Given by mouth
15977744|NCT03054038|Biological|Necitumumab|Given IV
15977745|NCT03054038|Other|Laboratory Biomarker Analysis|Correlative studies
15977746|NCT03054025|Device|Smart Phone Monitoring Device|Use activity tracker application
15977747|NCT03053999|Other|Genome Sequencing|Analyses includes genome sequencing based analysis to identify novel germline variations in blood DNAs and somatic changes in tumor DNAs, which may contribute to the development of pancreatic tumors.
15977748|NCT03053999|Other|Data Review|Clinical information retrieved from the patients' medical record including: de-identified demographic data (age, gender, race/ethnicity), medical history, family history, disease status, treatment response, survival information, and selected clinical data from medical record (calcium levels, calcitonin levels).
15977749|NCT03053986|Dietary Supplement|Apple polyphenols|1 tablet per day at evening before sleeping
15977750|NCT03053986|Other|Placebo|1 tablet per day at evening before sleeping
15977751|NCT03053973|Device|nocturnal noninvasive ventilation|Patients will be initiated on bilevel positive pressure non-invasive ventilation via a mask according to regular clinical practice.
15977752|NCT03053973|Other|Standard Care|Standard COPD care is given to all patients (pharmacological management, oxygen, rehabilitation if neccesary, etc.)
15977753|NCT03053960|Device|Computed Tomography|Undergo helical CT scan
15977754|NCT03053960|Device|Positron Emission Tomography and Computed Tomography Scan|Undergo PET/CT scan
15977755|NCT03053960|Device|Cone-Beam Computed Tomography|Undergo CBCT scan
15977756|NCT03053960|Device|Magnetic Resonance Imaging|Undergo MRI scan
15977757|NCT03053960|Procedure|Therapeutic Conventional Surgery|Undergo resection of tumor
15977758|NCT03053960|Procedure|Histopathologic Examination|Correlative studies
15977759|NCT03053947|Drug|Intranasal Ketamine|Administration of intranasal ketamine at a dose from 3 to 9 mg/kg for safe and effective procedural sedation for laceration repair in the ED for children aged 1 to 12 year-old.
15977760|NCT03053934|Behavioral|Online video-based counselling|Videoconferencing facilitates communication between individuals (i.e., the counsellor and the client) in different geographical locations enabling them to interact simultaneously with each other on a computer monitor in real time. In other words, both the client and the therapist communicate live using both visual and audio aids simulating in-person therapy albeit from two separate geographical locations.
15977761|NCT03053934|Behavioral|Traditional in-person counselling|"Traditional in-person counselling is often referred to as face-to-face and can be loosely defined as any mental health intervention, whereby the clinician is in the same room with a client. The terms in-person and same room are used less frequently, but it has been argued that these terms are more descriptive (since in videoconferencing, clients are also seen face-to-face on screen). Therefore, the current study uses the term in-person to describe traditional, face-to-face counselling."
15977762|NCT03053921|Procedure|recession coverage|recession coverage done using Zuchellis technique
15977763|NCT03053921|Procedure|recession coverage and membrane|recession coverage done using Zuchellis technique with placental membrane
15977764|NCT03053908|Procedure|Actigraphy|Recording of sleep/wake cycle and TST by actigraphy to be completed at home by subject over 7 days
15977765|NCT03053908|Procedure|Nocturnal Polysomnograpahy (NPSG)|N1 habituation and N2 data collection
15977766|NCT03053895|Procedure|CSDH - Bedside twist drill technique|For patients randomized to bedside drainage of CSDH, the twist-drill procedure will be conducted at the patient's bedside using local anesthetic
15977767|NCT03053895|Procedure|CSDH - Operating Room Burr-hole technique|For patients randomized to burr-hole drainage, the procedure will be performed in the operating room under local or general anesthesia based on the surgeon's and anesthesiologist's judgement of the clinical stability of the patient.
15977768|NCT03053882|Other|mouthwash|mouthwash containing herbal peppermint or green tea
15977769|NCT03053869|Drug|Benzodiazepine - limited use strategy|"No routine use of any intraoperative benzodiazepines.
~Accepted benzodiazepine use in the case of seizure, alcohol withdrawal, or known benzodiazepine dependence.
~Accepted benzodiazepine use in patients who are hemodynamically unstable and/or have cardiac anatomy that puts them at high risk of developing ischemia on induction of anesthesia."
15977770|NCT03053869|Drug|Benzodiazepine - Ad libitum strategy|"Administration of some benzodiazepine to most patients undergoing cardiac surgery.
~Accepted lack of benzodiazepine use in patients who have contraindications to the administration of these medications (e.g. documented allergy)."
15977771|NCT03053856|Drug|Pembrolizumab|Adjuvant pembrolizumab 200 mg every 3 weeks for up to 24 months. (treated with neoadjuvant concurrent chemoradiotherapy followed by curative resection)
15977772|NCT03053856|Procedure|Curative resection|Neoadjuvant concurrent chemoradiotherapy followed by curative resection
15977773|NCT03053856|Procedure|Neoadjuvant concurrent chemoradiotherapy|RT 44 Gy/22 Fractions for 5 weeks With Chemotherapy (Cisplatin 25mg/m2 once weekly, Paclitaxel 50mg/m2 once weekly)
15977774|NCT03053856|Drug|Cisplatin|25mg/m2 once weekly
15977775|NCT03053856|Drug|Paclitaxel|50mg/m2 once weekly
15978192|NCT03050359|Drug|Lansoprazole Placebo|Lansoprazole placebo-matching capsules
15978779|NCT03045770|Drug|Paclitaxel|Paclitaxel was used as first line treatment with AGC.
15977776|NCT03053843|Dietary Supplement|Mediterranean diet plus extra virgin olive oil|The patients in the intervention group will receive 1 liter of EVOO per week free of charge and dietary advice on how to follow a Mediterranean diet with contacts every two months. Dietary intervention will be carried out by nutritionists with previous experience in the PREDIMED study. All of them were registered, trained and certified for developing the PREDIMED intervention protocol that is similar to the one to be carried out in this study. The theoretical sessions with patients about dietary education shall be conducted in telephone form, using the internet and sending comprehensive written material to their homes that includes recipes, shopping lists, menus and explanations of typical food in the Mediterranean diet
15977777|NCT03053830|Drug|Ketamine|0.5mg/kg ketamine in normal saline. Infusion will be delivered during a 40 minute interval
15977778|NCT03053817|Other|Exercise group|Interval training will be performed for 21 minutes including a 3 minute warm-up and cool-down period. The interval program will be 15 minutes at 65-75% of maximal heart rate with 30 sec. bursts of exercise to 80-85%; intervals. Resistance training will be done as a circuit and will make use of weight machines and functional exercises. Resistance will be done in 2 sets of 15 repetitions and will last 24 minutes. The work load of the program is calibrated and is conducted at a specified rhythm. All exercise sessions will be supervised.
15977779|NCT03053804|Radiation|MR/PET|MR/PET with contrast media and FDG-18
15977780|NCT03053791|Procedure|Deep brain stimulation in mesencephalic locomotor region|Implantation of Electrodes in the Mesencephalic Locomotor Region for improvement of Locomotion and Gait
15977781|NCT03053791|Device|Implantation of a Deep brain stimulation system|Implantation of a Medtronic Activa SC Impulse Generator for chronic Stimulation of the selected target.
15977782|NCT03053778|Other|Early follow-up|Early follow-up until 4 weeks after discharge
15977783|NCT03053765|Other|training in IPT|Follow-up training in IPT to determine which best enhances fidelity
15977784|NCT03053752|Procedure|Transcutaneous Electric Nerve Stimulation|Eight sessions were held, once a week, lasting twenty minutes. For this purpose, the electrodes of the acoustic surface Taichong (LR-3), Hé gǔ (Ll-4), Yanglingquan (GB-34) and Neiguan (PC-6) connected to the TENS equipment (EL 608, brand NKL). The current of choice for a BURST type, with intermittent pulses, isolated at a frequency of 2 Hz, ranging from 1 to 10 mA.
15977785|NCT03053739|Drug|Sildenafil 20mg and Bosentan 62.5mg|Sildenafil 20 mg three times a day and bosentan 62.5mg two times a day
15977786|NCT03053739|Drug|Sildenafil 20mg and Placebo|Sildenafil 20 mg three times a day and placebo (matched for bosentan)two times a day
15977787|NCT03053726|Procedure|Variable Frequency Stimulation|vary the frequency of the stimulation parameter
15977788|NCT03053713|Behavioral|Mediterranean diet pattern|Subjects assigned to the Mediterranean diet pattern arm will receive nutrition advice from a Registered Dietitian (RD). The RD will meet with the subjects (in-person) to provide diet education at randomization, week 3 and week 6 of the intervention. Phone and e-mail follow-up will occur at week 2 and week 9 to provide cooking tips, recipes, videos and answer questions.
15977789|NCT03053713|Behavioral|Habitual diet (control)|Subjects assigned to follow their habitual group will be instructed to make no changes to their diet over 12 weeks.
15977790|NCT03053700|Drug|Bromonide 0.33% gel|Patients would be treated with full face application of bromonide 0.33% gel once daily for three months.
15977791|NCT03053700|Device|Intense Pulsed Light (M22)|Half of the patients' face would be subjected to three IPL treatment sessions three weeks apart from each other.
15977792|NCT03053687|Dietary Supplement|Nutritional supplementation standardized formula|Powder added to water, containing about 25% of recommended Daily Recommended Intake (DRI) for calories, high protein (25% of calories) and multivitamin and mineral (25%-100% of DRI for recommended daily allowance (RDA) or adequate intake
15977793|NCT03053687|Dietary Supplement|Placebo|Low caloric formula (Powder added to water) without added vitamins and mineral
15977794|NCT03053674|Other|Oral and written explanation|Oral and written explanation on importance of post-partum influenza vaccination for the health of their newborn infant
15977795|NCT03053674|Other|Follow-up questionnaire|Follow-up questionnaire to determine whether participants have receive post-partum vaccination
15977796|NCT03053648|Other|Self-acupressure|The subjects will be told to perform self-acupressure 30 min before sleep for 20 min every night for 4 weeks. Telephone follow-up will be made twice a week by the trained student research assistant during the 4-week treatment period to remind subjects to practice self-acupressure.
15977797|NCT03053648|Other|Sleep hygiene education|A training hand-out will be provided to each subject. The hand-outs included manualized sleep hygiene instructions. A registered nurse who has been trained by a clinical psychologist will be the instructor on sleep hygiene and activity scheduling. To enhance interaction and ensure the quality of teaching, each course will be conducted in a group of 5 participants.
15977798|NCT03053635|Drug|TLD1433 infusion and photodynamic therapy (PDT) treatment|TLD1433 is infused into the bladder, followed by repeated rinsing and treatment of bladder wall with photodynamic therapy (PDT).
15977799|NCT03053622|Biological|Mirikizumab Test|Administered SC
15977800|NCT03053622|Biological|Mirikizumab Test|Administered IV
15977801|NCT03053622|Biological|Mirikizumab Reference|Administered SC
15977802|NCT03053596|Device|DEB-TACE using anthracyclin loaded LifePearl™|The main purpose of this registry is to assess liver toxicity, treatment efficacy, and safety of DEB-TACE using anthracyclin loaded LifePearl™ for treatment of patients with unresectable hepatocellular carcinoma allocated to TACE treatment at multidisciplinary tumor board.
15977803|NCT03053583|Device|Laryngoscope blade|The POGO score assesses the percent of the glottic opening that can be seen with each blade
15977804|NCT03053570|Device|Cryoballoon|use Cryoballoon to isolation the Pulmonary Vein
15977805|NCT03053570|Device|Radiofrequency Energy(Contact Force)|use Radiofrequency Energy(Contact Force) to isolation the Pulmonary Vein
15977806|NCT03053557|Behavioral|Social Skills Coach|Social Skills Coach is a multi-platform interactive device that engages users with information and skills learned in social skills training programs. The program includes a web application and provider dashboard and encourages users to practice skills on the app and use them in the real world and then report how the application of skills was experienced.
15977807|NCT03053544|Drug|Metformin|Participants will self-administer 500mg metformin twice daily by mouth: 1) beginning 1-2 weeks prior to standard of care CRT, 2) during standard of care CRT and 3) until 30 days after the end of standard of care CRT.
15977808|NCT03053531|Device|"PockeTalker Hearing Assistive Device (HAD)"|Investigators will test impacts of the provision of the HAD on hearing and understanding, and preparation for discharge. Just prior to going home, consented subjects will answer a set of survey questions, using an electronic tablet to support impaired hearing.
15977809|NCT03053518|Device|Abbott Freestyle Libre Pro|A professional, blinded, continuous glucose monitoring device will be inserted on the back of the upper arm to measure interstitial glucose every 5 min for 4 times / day.
15977810|NCT03053518|Behavioral|LifeStyle|Isocaloric diets (breakfast, lunch, dinner, and 2 snacks), which will be prepared and delivered daily, including 2 days each of low, moderate, and high glycemic load (GL) foods.
15977811|NCT03053505|Biological|faecal human microbiota transplant (FMT)|"Non-randomized group R: Patients with recurrent CD infection are treated with FMT in this group.
~Randomized group FFMT: patients with initial CD infection who have severe disease or who are at high risk of recurrence or high risk of developing severe disease are treated with FMT."
15977812|NCT03053505|Drug|Vancomycin or Fidaxomicin|"Randomized group FAB: patients with initial CD infection who have severe disease or who are at high risk of recurrence or high risk of developing severe disease are treated with antibiotics (vancomycin per os 125mg four times a day for 10 days) in this group. In case of treatment failure changes in antibiotic regime (e.g. fidaxomicin per os 200mg per two times a day for 10 days) will be allowed in the line with the recommendations of current CDI treatment guidelines(13)."
15977813|NCT03053492|Device|Duck Duck Punch Play|The behavioral intervention will include playing a hands-free video game custom designed for stroke survivors.
15977814|NCT03053492|Behavioral|Commercially Available Game Play|The behavioral intervention will include playing a hands-free video game available off-the-shelf.
15977815|NCT03053479|Procedure|Laparoscopic sacrocolpopexy|see arm/group descriptions
15977816|NCT03053479|Procedure|Transvaginal mesh procedure|see arm/group descriptions
15977817|NCT03053479|Procedure|Amreich-Richter procedure|see arm/group descriptions
15977818|NCT03053466|Drug|APL-501|"Subjects will be assigned to a dose level in the order of study entry. Treatment includes a minimum of four 28-day cycles at three planned dose levels (1, 3, and 10 mg/kg). In the Dose Escalation Segment, each treatment cycle is comprised of 2 doses of study drug administered on Days 1 and 15 of a 28-day cycle. In the Cohort Extension, the treatment cycle will consist of 2 doses of study drug administered on Days 1 and 15 of a 28-day cycle.
~In Dose and Disease Expansion, the treatment cycle will consist of 2 doses of study drug (non-weight based dosing of 400 mg) administered on Days 1 and 15 of a 28-day cycle."
15977819|NCT03053453|Procedure|Spinal Surgery|TKA under standard of care spinal surgery.
15977820|NCT03053453|Device|Verasense Knee System device|Sensor measures and localizes peak load at the medial and lateral tibiofemoral joint interfaces. Loading data is thereby captured intra-operatively through the full range of movement (ROM) using the sensor system.
15977821|NCT03053440|Drug|BGB-3111|160mg PO BID until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
15977822|NCT03053440|Drug|Ibrutinib|420mg PO QD until progressive disease, unacceptable toxicity, death, withdrawal of consent, or study termination by sponsor
15977823|NCT03053427|Drug|Placebo|Oral administration
15977824|NCT03053427|Drug|Gabapentin enacarbil|Oral administration
15977825|NCT03053414|Dietary Supplement|Vitamin D (ergocalciferol and/ or cholecalciferol)|To evaluate effective repletion and supplementation for Vitamin D levels in patients with inflammatory bowel disease.
15977826|NCT03053401|Procedure|Adductor Canal Block|Under guidance of a linear ultrasound transducer probe (General Electric; GE). Performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg ( maximum of 40 mg ).
15977827|NCT03053401|Procedure|Femoral Nerve Block|Under guidance of a linear ultrasound transducer probe (General Electric;GE).Block will be performed using a 22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany).Solution to be injected will be a combination of Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) and methylprednisolone acetate 1 mg/kg (maximum of 40 mg ).
15977828|NCT03053401|Device|Ultrasound|Use of linear ultrasound transducer probe (General Electric;GE) to guide needle placement for both Adductor Canal Block and Femoral nerve Blocks
15977829|NCT03053401|Device|Stimuplex A needle|22-gauge 2-inch Stimuplex A needle ( B. Braun Medical Inc., Melsungen, Germany) used to perform both Adductor Canal Block and Femoral nerve Blocks.
15977830|NCT03053401|Drug|local anaesthetic injection|Ropivacaine 0.2 % ( 0.5 ml/kg, maximum of 30 ml) for either Adductor Canal Block and Femoral nerve Blocks.
15977831|NCT03053401|Drug|Steroid Drug|Methylprednisolone acetate 1 mg/kg (maximum of 40 mg ) for either Adductor Canal Block and Femoral nerve Blocks.
15977832|NCT03053388|Drug|Nitric Oxide|Nitric Oxide given via inhalation in cycles
15977833|NCT03053388|Other|Supportive treatment|Supportive treatment (including oxygen)
15977834|NCT03053375|Device|MDCure|Battery powered portable pulsed electromagnetic therapy device
15977835|NCT03053362|Drug|Vortioxetine|Observing change in cognition using THINC-it tool in patients with MDD.
15977836|NCT03053362|Other|THINC-it Tool|"Digitalized cognitive test application administering the following cognitive test components:
~Digit Symbol Substitution Test (DSST) Choice Reaction Time (CRT) One-back working memory tool Trail Making Test B (TMT-B) Perceived Deficits Questionnaire-5 Depression (PDQ-5-D)"
15977837|NCT03053336|Behavioral|App-technology to increase physical activity|Access to the smartphone-app during 12 weeks. A personal step goal is set for each individual in the app.
15977838|NCT03053323|Behavioral|Lifestyle Intervention|The lifestyle intervention consists of three components: nutrition, physical activity, and other areas of wellness. The intervention is administered individually each week for 10 weeks and is tailored for women with a history of depression who are in the first trimester of pregnancy or trying to conceive.
15977902|NCT03052751|Drug|UCB7665|UCB7665 will be administered in 2 different dosages (dose 1 and dose 2). UCB7665 (INN: Rozanolixizumab) is a humanized monoclonal antibody that is being developed for treatment of IgG autoantibody-mediated conditions such as myasthenia gravis (MG)
15977903|NCT03052751|Other|Placebo|Placebo will be administered in period 1 of dosage regimen 2.
15977904|NCT03052725|Drug|reslizumab|Reslizumab was provided in a pre-filled syringe.
15977839|NCT03053297|Other|Patient Reported Outcomes|"HRQoL will be assessed using questionnaire EORTC QLQ-C30 and the questionnaire EORTC QLQ-LC 13.
~These two questionnaires are validated instruments, translated in various languages and are not used as an intervention but rather to track patient quality of life and symptom reduction in real-life settings. Data for these patient reported outcomes will be collected prospectively from the time of enrolment until the end of follow-up. The two questionnaires will be self-administered by the patients in both cohorts at the enrolment visit and subsequently every 3 months (±1 month) at routine standard of care scheduled visits. The questionnaires are expected to take about 15 minutes to complete"
15977840|NCT03053284|Drug|Pasireotide 0.6Mg Solution for Injection|Pasireotide 0.6Mg Solution for Injection will be given once per study visit
15977841|NCT03053284|Drug|Saline Solution|Saline Solution injection will be given once per study visit
15977842|NCT03053271|Drug|ATR-101|During the 4-week randomized withdrawal period, subjects will be dosed for 4 weeks at the same dose level being used at the completion of the open-label dose-escalation period.
15977843|NCT03053271|Drug|Placebo|During the 4-week randomized withdrawal period, subjects will be dosed for 4 weeks with placebo that matches the same ATR-101 dose level being used at the completion of the open-label dose-escalation period.
15977844|NCT03053258|Device|Collection of exhaled breath sample|Collect exhaled breath sample from patients with suspected VAP
15977845|NCT03053245|Behavioral|Mobile Critical Care Program|The m-CCRP revolves around the central figure of a care coordinator who will organize and align recovery resources. The care coordinator is a registered nurse whose scope of practice includes health coaching, case managing, community organizing, and nursing care provider. The m-CCRP support team will consist of a critical care physician (Dr. Khan), a geriatrician with expertise in collaborative care (Dr. Boustani), an ICU collaborative care nurse (Dr. Lasiter), and a psychologist (Dr. Unverzagt). This team will meet weekly with the care coordinator. Drs. Khan and Boustani will be accessible to the coordinator through phone or pager at all times.
15977846|NCT03053245|Behavioral|Attention Control|Patients in this group will receive regular wellness calls from the research team.
15977847|NCT03053232|Device|Purse string suture device|Using purse string suture device to close gastrointestinal perforation under endoscopy.
15977848|NCT03053232|Device|Endoclips|Using endoclips to close gastrointestinal perforation under endoscopy.
15977849|NCT03053219|Drug|AC0010|Oral dose of 300mg bid,the two doses are advised to be administered at an interval of 12 hours
15977850|NCT03053206|Drug|ADE Protocol|"ADE chemotherapy
~Cytarabine (100mg/m2 d1-d10 BD), Daunorubicin (50mg/m2 d1-d3) and Etoposide (100 mg/m2 d1-5) over a period of 10 days"
15977852|NCT03053167|Drug|Irinotecan|Irinotecan: 180mg/㎡+NS250ml, ivgtt, 90min, d1 Every 3 weeks
15977853|NCT03053167|Drug|Raltitrexed|Raltitrexed: 3mg/㎡+NS100ml，ivgtt，15min, d1 Every 3 weeks
15977854|NCT03053154|Other|Sagittal pelvic tilt assessment|Each group passed by three phases of assessment. Firstly assess the pelvic tilt angles from sitting position. Secondly assess the pelvic tilt angles from dynamic sit to stand task. Thirdly, assess the ability to perform sit to stand task of each participant.
15977855|NCT03053141|Device|Rhythmia Mapping System|The Rhythmia Mapping System is a 3D electro-anatomical mapping system.
15977856|NCT03053128|Device|Cardiac shock wave therapy|Patients in CSWT group will receive CSWT for a 3-month therapy, located in their ischemia area with a energy of 0.09mJ/mm2. Patients will get therapy on every first week of the month and rest for following three weeks.
15977857|NCT03053128|Other|Sham cardiac shock wave (Control group)|Patients in sham CSWT group will receive sham cardiac shock wave, which is segregated by an air cushion.
15977858|NCT03053115|Drug|Liothyronine|Cases will take liothyronine drops in the morning and two hours after dinner
15977859|NCT03053115|Drug|Levothyroxin|Both cases and controls will take levothyroxine in the morning (entire dose for controls, reduced dose for cases)
15977860|NCT03053115|Drug|Placebos|Controls will take placebo two hours after dinner
15977861|NCT03053102|Drug|Danicopan|Danicopan was administered as multiple oral doses over a period of at least 28 days.
15977862|NCT03053089|Drug|AGT-181|Human Insulin Receptor Monoclonal Antibody-Human alpha-L-iduronidase (HIRMAb-IDUA) Fusion Protein
15977863|NCT03053076|Other|Autologous Umbilical Cord Blood Mononuclear Cells Therapy|Autologous Umbilical Cord Blood Mononuclear Cells Therapy in preterm for safety and effect evaluation
15977864|NCT03053076|Drug|0.9% Sodium Chloride|0.9% Sodium Chloride in control group
15977865|NCT03053063|Drug|SEL|Tablets administered orally once daily
15977866|NCT03053063|Drug|Placebo to match SEL 6 mg|Tablets administered orally once daily
15977867|NCT03053063|Drug|Placebo to match SEL 18 mg|Tablets administered orally once daily
15977868|NCT03053050|Drug|SEL|Tablets administered orally once daily
15977869|NCT03053050|Drug|Placebo to match SEL 6 mg|Tablets administered orally once daily
15977870|NCT03053050|Drug|Placebo to match SEL 18 mg|Tablets administered orally once daily
15977871|NCT03053037|Procedure|final apical size instrumentation|root canal instrumentation to two different final preparation sizes
15977872|NCT03053011|Other|Vibrating bracelet|A bracelet with vibrations triggered randomly overnight. The sleeper's awakening capability will be evaluated each time the bracelet vibrates (5 times in the night).
15977873|NCT03052998|Drug|Ivermectin|Effect of Ivermectin on frequency of seizures
15977874|NCT03052985|Procedure|urinary incontinence, pelvic organ or rectal prolapse surgery|The observatory is planned for following women after surgery for urinary incontinence, pelvic organ prolapse, or rectal prolapse whatever the type of surgery (by laparoscopy, laparotomy or vginal route) or the use of a mesh
15977875|NCT03052972|Drug|Flortaucipir F18|370 megabecquerel (MBq)(10 millicurie [mCi]) single dose
15977876|NCT03052972|Procedure|Brain PET scan|positron emission tomography (PET) scan of the brain
15977905|NCT03052712|Behavioral|social cognition|battery of tests of social cognition
15977906|NCT03052699|Procedure|vaginal Cesarean Section|follow-up to patients operated for vaginal Cesarean Section
15977907|NCT03052686|Other|Childbirth with uterine rupture|No intervention. Follow-up of women with rupture uterine at the childbirth.
15978503|NCT03048110|Drug|Rifampicin|600 mg QD administered as 1 x 600 mg tablet per dose in treatment period 3 on Study Days 1 to 10.
15977877|NCT03052959|Behavioral|Immediate Intervention|The 'BETTER' prevention practitioner intervention involves assessment of a person's current participation, or lack of participation, among domains of evidence-based chronic disease prevention and surveillance (CDPS) actions. The assessment is followed several days later by a supportive meeting with a prevention practitioner nurse, using principles of shared decision making and health coaching, to establish goals for accomplishing CDPS activities of the individual's choice during the subsequent six months to develop personal goals and targets for participating in CDPS actions during the following six months. In BETTER HEALTH: DURHAM, the prevention practitioner nurse will be a public health nurse from the Durham Region Health Department.
15977878|NCT03052959|Other|Wait List Intervention|The control arm will receive the prevention practitioner intervention 6 months after the intervention arm. Their outcomes will not be assessed in the study.
15977879|NCT03052946|Procedure|Bulking agent|Filling bulking agent in the anal canal
15977880|NCT03052946|Procedure|Endoanal electrostimulation|The technique used will be with a frequency of 30 to 40 Hz with pulse width of 200 ms with maximum intensity of 800mAmp and duration of 30 minutes
15977881|NCT03052933|Drug|Copanlisib|"For phase I study, participants will receive copanlisib (in combination with gemcitabine) IV infusion at a dose of 45 mg or 60 mg on Days 1, 8, and 15 of each 28-day treatment cycle. During phase I study, participants will be treated at the level of 45 mg/dose (level+0), or 60 mg/dose (level+1) of copanlisib. Maximal tolerated dose will be determined by modified 3+3 design including level-1 dose de-escalation.
~For phase II study, copanlisib dose level, determined during phase I study, will be administered on Days 1, 8, and 15.
~Maximum 6 cycles of gemcitabine and copanlisib combination and subsequent copanlisib monotherapy in participants with ≥ SD to copanlisib and gemcitabine until maximum 12 cycles will be given for this study."
15977882|NCT03052933|Drug|Gemcitabine|For phase I/II study, participants will receive gemcitabine (in combination with copanlisib) IV infusion at fixed dose of 1,000 mg/m2 on Days 1 and 8 of each 28-day treatment cycle until maximum 6 cycles.
15977884|NCT03052907|Behavioral|BSPAN|"Identify readiness assessment criteria (RAC) essential in determining a rural county's capacity to support comprehensive mammography and appropriate follow-up services.
~Using the RAC, we will determine which of the five BSPAN1 counties have capacity to manage and sustain the Outreach & Health Promotion and Delivery & Navigation components of the program (High Capacity), and which have the capacity to manage and sustain only the Outreach & Health Promotion component (Medium Capacity).
~Expand BSPAN to 12 new rural and underserved counties according to RAC score and evaluate each county's ability to implement program components and increase comprehensive mammography and appropriate follow-up."
15977885|NCT03052894|Device|Hydraulic Monitoring Device|"The hydraulic monitoring device externally measures the pressure associated with thumb strength applied to the device to determine the depth of neuromuscular blockade during general anesthesia.
~This will be compared to measurements using a current monitoring device in the same patient."
15977886|NCT03052894|Device|Standard EMG Monitoring Device|"Standard and in current usage, the electromyographic monitoring (EMG) device externally measures the action potential of the muscles of the thumb to determine the depth of neuromuscular blockade during general anesthesia.
~This will be used as the clinical monitoring device and as a comparator."
15977887|NCT03052881|Device|Robot assisted surgery|The PRECEYES Surgical System is a robotically assistive device developed by PRECEYES Medical Robotics, a Dutch-based research group at the Technische Universiteit Eindhoven. It has been designed to enhance surgical precision, specifically for vitreoretinal eye surgery. The device provides accuracy beyond human capabilities of <10μm in all directions (x, y, z planes). The surgeon is always in control of the instrument by manipulating the motion controller.
15977888|NCT03052868|Other|Cognitive Assessment|Cognitive testing session
15977889|NCT03052855|Other|Magnetic Resonance Imaging (MRI) and biological samples|Participants will have to do a MRI and biological samples.
15977890|NCT03052842|Drug|C16G2 Strip|Antimicrobial Peptide
15977891|NCT03052842|Other|Placebo Strip|Placebo
15977892|NCT03052829|Behavioral|Physical activity counseling|Subjects in this arm will receive counseling on how to increase their physical activity level.
15977893|NCT03052829|Behavioral|Usual care|Subjects will undergo their usual care without intervention
15977894|NCT03052816|Drug|Ice T|Ice/Tylenol/Toradol with dilaudid for breakthrough
15977895|NCT03052816|Drug|Motrin/Percocet/Dilaudid for breakthrough|Standard regimen
15977896|NCT03052803|Device|Fractional flow reserve measure|Comparison of different devices measuring fractional flow reserve
15977897|NCT03052790|Procedure|manually instrumented total knee arthroplasty|Manually instrumented implantation of a total knee prosthesis involves use of cutting guides or jigs that are secured to the femur and the tibia. The femoral guide is secured to the femur after an intramedullary referenced guide is placed into the femur and the rotational alignment is then assessed with use of the epicondylar axis. An extra-medullary tibial alignment guide will be used to create the tibial cut.
15977898|NCT03052790|Device|robotic assisted total knee arthroplasty|Robotically assisted surgery is used in conjunction with the preoperative CT scan and intra-operative bony registration of the patient's knee. Femoral and tibial trackers are placed and then the bone is registered using bony landmarks to allow the computer and robot to know where the patients' femur and tibia are in space. Once this is complete the preoperative templated surgical plan (performed by the PI) is used to register where to make the bony cuts in order to implant the knee components. The cutting process is performed by the surgeon with the robot assisting in guiding the cuts based on the registered CT anatomy. The surgeon has complete control of the cutting process with the assistance of the robot for placement of the cuts.
15977899|NCT03052777|Behavioral|Telephone counselling|The intervention is a 12 week telephone counselling exercise program where participants will receive weekly telephone counselling that targets key theoretical behavior change constructs. Participants will also receive a copy of Canada's Physical Activity Guideline.
15977900|NCT03052764|Biological|onabotulinumtoxinA|OnabotulinumtoxinA (BOTOX®) injection into the bladder.
15977901|NCT03052764|Drug|Placebo (saline)|Placebo (saline) injection into the bladder.
15979103|NCT03043365|Drug|LCMUFA-rich saury oil|4 capsules, 3 times a day after meals
15977908|NCT03052673|Drug|Fentanyl|Fentanyl 1mcg/kg will be given at induction of anaesthesia followed by intraoperative infusion of 0.5 mcg/kg/hr in both the arms . Postoperatively IV-PCA pump containing fentanyl will be attached to patients in both the arms
15977909|NCT03052673|Drug|ketamine|Ketamine 0.5 mg/kg will be given post-induction of anaesthesia followed by infusion of 0.5 mcg/kg /hr in the Ketamine + Fentanyl group arm
15977910|NCT03052660|Drug|Midazolam|Oral administration preoperatively
15977911|NCT03052660|Drug|Placebo oral capsule|Oral administration preoperatively
15977912|NCT03052647|Device|Dermaclip|Dermaclip is an adhesive latch device used for skin closure
15977913|NCT03052647|Device|Subcuticular suture|subcuticular suture will be used as the device to close the skin in this arm
15977914|NCT03052634|Drug|RC48-ADC 1.5 mg/kg (HER2 Positive)|15 advanced breast cancer participants with HER2 Positive will be treated with RC48-ADC at a dose of 1.5 mg/kg, every 2 weeks. They will continue the medication until one of the following conditions occurred: disease progression, intolerance of toxicity, withdrawal of informed consent, or treatment for 1 year.
15977915|NCT03052634|Drug|RC48-ADC 2.0 mg/kg (HER2 Positive)|15 advanced breast cancer participants with HER2 Positive will be treated with RC48-ADC at a dose of 2.0mg/kg, every 2 weeks. They will continue the medication until one of the following conditions occurred: disease progression, intolerance of toxicity, withdrawal of informed consent, or treatment for 1 year.
15977916|NCT03052634|Drug|RC48-ADC 2.5 mg/kg (HER2 Positive)|15 advanced breast cancer participants with HER2 Positive will be treated with RC48-ADC at a dose of 2.5 mg/kg, every 2 weeks. They will continue the medication until one of the following conditions occurred: disease progression, intolerance of toxicity, withdrawal of informed consent, or treatment for 1 year.
15977917|NCT03052634|Drug|RC48-ADC 2.0 mg/kg (HER2 Low Expression)|45 advanced breast cancer participants with HER2 Low Expression will be treated with RC48-ADC at a dose of 2.0 mg/kg, every 2 weeks. They will continue the medication until one of the following conditions occurred: disease progression, intolerance of toxicity, withdrawal of informed consent, or treatment for 1 year.
15977918|NCT03052621|Procedure|Omental transposition|Harvesting the omentum to cover irradiated defects of breast cancer
15977919|NCT03052608|Drug|Lorlatinib|ALK-positive NSCL treatment
15977920|NCT03052608|Drug|Crizotinib|ALK-positive NSCL treatment
15977921|NCT03052595|Diagnostic Test|Oral glucose tolerance test|Oral glucose tolerance test to measure glucose and insulin concentrations after oral glucose load
15977922|NCT03052595|Diagnostic Test|Testing of autonomous nervous system function|Autonomous nervous system function will be assessed using a battery of tests (orthostasis, Valsalva manoeuvre, heart rate variability recording, blood hormone levels, ect.)
15977923|NCT03052595|Diagnostic Test|Stroop test|Stroop test will be used to test cognitive function
15977924|NCT03052582|Other|Milk type|
15977925|NCT03052569|Drug|RXDX-105|Oral Capsules
15977926|NCT03052556|Procedure|Pap smear test and HPV test|"Included women will attend a consultation with a gynaecologist. Pap smear test with HPV test will be performed. Samples collected by cervical scrape with a brush, will be prepared for liquid-based cytology. A sample of the sample will be used for research on HPV (Multiplex DNA PCR).
~This method allows detection of 35 different HPV genotypes: high risk (HPV-16, -18, -26, -31, -33, -35, -39, -45, -51, -52, 53, -56, -58, -59, -66, -68, -70, -73, -82, and -85); and low risk (HPV-6, -11, -40, -42, -43, -44, -54, -61, -62, -71, -72, -81, -83, -84, and -89).
~Patients with an initial abnormal pap smear or a positive HPV test will be monitored:
~In case of an abnormal smear and / or positive HPV test, pap smear and HPV testing will be renewed every 6 months during the study period
~In case of an abnormal smear:
~ASC-US: the attitude will depend on the result of the HPV test ASC-H, LSIL, HSIL, AGUS, AGC, AIS, carcinoma: a colposcopy will be performed"
15977927|NCT03052543|Device|BIS™ Complete 2--Channel Monitor|monitor depth of anesthesia
15977928|NCT03052530|Device|Sapphire II PRO|To pre-dilate coronary arteries or bypass grafts during the subject's index procedure with Sapphire II PRO 1.0 and 1.25 PTCA dilatation catheters.
15977929|NCT03052517|Drug|QAW039 150 mg|One tablet of QAW039 150 mg once daily
15977930|NCT03052517|Drug|QAW039 450 mg|One tablet of QAW039 450 mg once daily
15977931|NCT03052517|Drug|Placebo|One tablet of Placebo once daily
15977932|NCT03052504|Other|Registration of complications|Prospective registration
15977933|NCT03052491|Dietary Supplement|Stem Cell 100+|Open-Label 10-Component Dietary Supplement
15977934|NCT03052478|Drug|Vismodegib 150 mg|Vismodegib 150 mg will be administered orally once a day for 21 days as one cycle.
15977935|NCT03052465|Other|Test soup meal feeding intervention|Cream of chicken soup (400g) (or mushroom for vegetarians) (Heinz, Wigan, UK) used as a test meal intervention. The nutrient content /100g is: energy (kcal) 51, protein (g) 1.5, carbohydrate (g) 4.7, fat (g) 2.93
15977936|NCT03052452|Other|My Nutritional Health App|The My Nutritional Health app built in LifeData will be used as the data collection platform for this study. We will use the data collected in the app testing to develop population-level FAST scores.
15977937|NCT03052439|Other|FODMAP|After 2 weeks on a low FODMAP diet, subject will undergo a reintroduction period. 5 different FODMAPs will be reintroduced (1 week at a time, followed by 1 week washout) in a blinded, randomized fashion.
15977938|NCT03052426|Device|Ergotron WorkFit - TL|A sit to stand work station.
15977939|NCT03052413|Dietary Supplement|Nutrafol|Eligible subjects will receive Nutrafol® to take daily for 180 days
15977940|NCT03052413|Dietary Supplement|placebo|Eligible subjects will receive Placebo to take daily for 180 days
15977941|NCT03052400|Drug|Mifepristone 600 mg daily|Glucocorticoid receptor antagonist
15977942|NCT03052400|Drug|Placebo|Matching placebo
15977943|NCT03052387|Other|assigned intervention|"* Local anesthesia with vasoconstrictor(V.C) used for hemostasis.
~chin block graft
~Scrubbing and draping of the patient will be carried out in a standard fashion using betadine surgical scrub.
~The donor site is usually the chin area, its approached using local anesthesia with VC at symphysis region.
~Low vestibular incision exposing the symphysis area to the inferior border of the mandible.
~Using fissure bur to harvest the graft for the defect.
~Closure using vicryl 3-O sutures."
15977999|NCT03051906|Radiation|Intensity modulated radiation therapy (IMRT)|A total dose of 69.9 Gy will be given with 2.12 Gy dose per fraction, delivered in 33 fractions over 7 weeks.
15978000|NCT03051893|Drug|Chronocort|Modified formulation of hydrocortisone
15977944|NCT03052374|Behavioral|VID-KIDS Intervention Program|"Investigators created VID-KIDS for mothers with PPD to improve sensitivity and positive responsiveness towards their infants. Video-feedback has the advantage of being visually concrete yet distant because the action and the feedback are not concurrent; this helps mothers maintain an element of objectivity that may minimize guilty feelings associated with potential perceived lack of parenting skills. Video-feedback interventionists are trained by investigators with manualized modules. Including: Introduction to Video-feedback; NCAST Keys to Caregiving Program; Infant Engagement and Disengagement Cues; Video-feedback Intervention Protocol; Overview of Behaviours of Interest; Case Studies; and Examples of Strengths-Based Feedback. VID-KIDS intervention follows an 8-step protocol."
15977945|NCT03052361|Drug|Ondansetron|Patients allocated to this arm will receive ondansetron in the ED triage.
15977946|NCT03052361|Drug|Placebos|similar looking and tasting liquid placebo
15977947|NCT03052348|Other|Polyethylene glycol hexadecyl ether & Betamethasone valerate cream 0.1%|Polyethylene glycol hexadecyl ether -Moisturizer. Betamethasone valerate cream 0.1% -Topical steroid
15977948|NCT03052348|Other|Fusidic acid, polyethylene glycol hexadecyl ether & Betamethasone valerate cream 0.1%|Polyethylene glycol hexadecyl ether -Moisturizer. Betamethasone valerate cream 0.1% -Topical steroid Fusidic Acid - Topical Antibiotic
15977949|NCT03052335|Device|Pillcam® COLON 2 Capsule|The second generation of PillCam colon capsule endoscopy (CCE-2) is 11.6 mm × 31.5 mm in size and has two imagers, that each have a 172° angle of view, allowing for almost 360° visual coverage of the colon. CCE-2 has an adaptive frame rate from 4 to 35 images per second. This means that the camera is able to capture up to 35 pictures while in motion whereas 4 images per second are captured when it is virtually stationary. During the examination the patient wears a sensor array which is attached to the abdomen and a data recorder for storage of the information generated by the ingested capsule. After the examination the data are downloaded into the workstation and a video is generated.
15977950|NCT03052335|Procedure|Colonoscopy|Optical colonoscopy is the standard method for evaluating the colon
15977951|NCT03052322|Drug|MSB11022|Participants received MSB11022 (modified buffer and stabilizer) subcutaneously at dose of 40 milligram (mg) every other week from Day 1 up to Week 48.
15977952|NCT03052322|Drug|EU-Humira|Participants received EU-Humira subcutaneously at dose of 40 mg every other week from Day 1 up to Week 48.
15977953|NCT03052309|Device|Passeo-18 Lux DCB|The decision to treat the patient with Passeo-18 DCB is at the investigator discretion. The endovascular procedure is performed as per standard of care and device Instructions For Use (IFU)
15977954|NCT03052296|Device|Passeo-18 Lux DCB|The endovascular procedure is conducted as per the local standard practice and device instruction for use
15977955|NCT03052283|Other|Questionnaire|non-interventional
15977956|NCT03052270|Drug|Arabin Pessary|Insertion of Arabin pessary for the prevention of preterm delivery
15977957|NCT03052257|Behavioral|Educational - glaucoma|Discussion of glaucoma and the potential for blindness, facilitated by the glaucoma educator using a 3-dimensional model eye and photographic representation of glaucomatous vision loss; One-one-one demonstration of eye drop instillation techniques, Provision of a mnemonic aid which alerts the participant to missed doses; Review of the participant manual: An illustrated brochure on glaucoma and eye drop instillation. An individualized schedule for dosing of glaucoma medications. Individualized suggestions for improving adherence based on the subject's responses to the (SASES).
15977958|NCT03052257|Behavioral|Dose monitoring and reminder|"Participants will be provided with a smart bottle to house one of their glaucoma medications. The smart bottle records the date and time that the bottle is opened. For participants in the intervention arm only, a reminder through AdhereTech will be activated."
15977959|NCT03052257|Behavioral|Educational - general|The control information session will include review of a Powerpoint presentation on general eye health, including but not specific to glaucoma.
15977960|NCT03052257|Behavioral|Dose monitoring|"Participants will be provided with a smart bottle to house one of their glaucoma medications. The smart bottle records the date and time that the bottle is opened."
15977961|NCT03052244|Device|tDCS+VI|2mA will be delivered over 20min to M1 via neuroConn DC stimulator combined with video presenting walking legs.
15977962|NCT03052244|Device|tDCS Sham+VI Sham|2mA will be delivered up to 30 sec to M1 via neuroConn DC stimulator combined with video presenting graphical illustration or nature movie for total duration of 20 min.
15977963|NCT03052231|Device|caremessage|Central to the mobile health information service is the interactive and personalized text-based message system that delivers actionable and tailored health content to participants: office visit appointment reminders; medication adherence reminders; and general health education messages.
15977964|NCT03052218|Device|Pupillometry|Pupillometry performed before administration of tramadol, at T0 and then 1 to twice per hour, during the stay of the patient in the emergency department
15977965|NCT03052205|Drug|IMO-2125|IMO-2125 will be administered by intratumoral injection on Days 1, 8, and 15 of Cycle 1 and on Day 1 of each subsequent cycle.
15977966|NCT03052179|Dietary Supplement|Poly-biotic|Before-after treatment
15977967|NCT03052166|Device|QT Ultrasound scan|QT Ultrasound scan
15977968|NCT03052153|Other|No investigational intervention performed for this study|No investigational intervention for the purpose of this study was performed; data collected is retrospective data previously collected for non-research purposes.
15977969|NCT03052140|Device|Lamelleye Dry Eye Drops|Liposomal multi-dose preservative-free sterile suspension which contains soy lecithin phospholipids, sphingomyelin and cholesterol, suspended in saline.
15977970|NCT03052140|Device|Optive Plus|Multi-dose sterile solution which contains sodium carboxymethylcellulose, glycerine, Castor Oil, Polysorbate 80, levocarnitine, and erythritol, preserved with PURITE® which breaks down into natural tear components in the eye
15977971|NCT03052127|Drug|Light-activated AU-011|Study treatment
15977972|NCT03052114|Device|Electrical Impedance Tomography|EIT comprises of a box of electronics similar in size to a video recorder, laptop computer and leads which link typically to 16 or 32 external ECG-like electrodes placed around the subject. Images are generated by applying tiny electrical signals through some electrodes and recording the resulting signals at others. The signals applied are completely safe, within established British and EU safety limits and cannot be felt.
15978072|NCT03051308|Combination Product|NPT and UW Solution|Tissue preservation solutions for transplantation
15977973|NCT03052075|Other|Retrospective Data Review|Retrospective, uncontrolled pre- and post-test design in a case series of approximately 250 patients who underwent parathyroidectomy at MD Anderson Cancer Center (years 1990 - 2013 ) and had bone density measures recorded at baseline and at one year post-surgery. Data extracted from the surgical oncology database for bone mineral density measures for each patient at multiple sites including the lumbar spine, total hip (right/left), femoral neck (right/left), and distal 1/3 radius. All measures recorded from two time points: presurgical (baseline) and postsurgical (all follow-up available dates beginning at 1 year post-parathyroidectomy).
15977974|NCT03052062|Dietary Supplement|Lipidrive|LipiDrive, 4 to 8 capsules per day, oral administration. Dose 1: 2.6 g Lipidrive per day Dose 2: 5.2 g Lipidrive per day
15977975|NCT03052049|Device|Prostate Artery Embolization|The PAE procedure will be completed on all enrolled patients in Interventional Radiology includes a pelvic/prostate angiogram and embolization with Bead Block microspheres to slow/block blood flow to the prostate.
15977976|NCT03052036|Procedure|Coronary Angiography|Coronary angiography to determine location of blocked or narrowed arteries.
15977977|NCT03052036|Procedure|Coronary revascularisation|PCI or CABG will be performed following coronary angiography at the discretion of the treating cardiologist.
15977978|NCT03052036|Other|Optimal Medical Therapy|Patients to receive conservative treatment in the form of guideline recommended secondary prevention therapy including antiplatelet therapy, statins, ACE Inhibitors and beta blockers.
15977979|NCT03052023|Procedure|dual approach laparoscopic inguinal hernioplasty|after pneumoperitoneum is done preperitoneal pneumo-dissection is done and then peritoneal incision done . dissection preperitoneally and sac dissection will be easy approached
15977980|NCT03052023|Procedure|TAPP|pneumoperitoneum is done and then through abdominal approach peritoneal dissection in done and sac reduction and then mesh fixation
15977981|NCT03052023|Procedure|(lichtenstein) repair|inguinal incision is done and inguinal canal approach anteriorly and then sac dissection and excision then mesh fixation to posterior wall and closure the incision in layers
15977985|NCT03051997|Behavioral|Caregiver Contingency Management + Usual Drug Court Treatment|In addition to receiving JDC treatment as usual described below, caregiver participants will receive prize draws for engaging in activities consistent with their adolescents' successful completion of the JDC program during the time the youth is actively involved in JDC and substance abuse treatment. Specific activities that may be reinforced include: attendance at drug court hearings; accompanying the youth to probation meetings; participating in home visits; attendance at the youth's drug treatment sessions; attendance at mental health provider meetings; attending groups for parents of youth with substance abuse issues; and completing other verifiable treatment-related activities. All activities will meet the goals of (directly or indirectly) enhancing caregiver participation in the JDC and/or treatment process. Caregivers will receive escalating chances for tangible reinforcers each week for completing up to 3 of the activities agreed upon by the caregiver and the therapist.
15977986|NCT03051997|Behavioral|Usual Drug Court Treatment|Standard outpatient substance abuse treatment services that a young person would receive while participating in JDC.
15977987|NCT03051984|Device|Neuromuscular electrical stimulation|NMES will be conducted on the quadriceps of the operative leg using a portable stimulation device, starting within 48-72 hrs of surgery. The operative leg will be immobilized at a neutral angle (~30º), with electrodes affixed to the anterior surface of the thigh. Symmetrical, biphasic pulses (400 µs duration at 50 Hz) will be used, with a duty cycle of 25% (10 s on, 30 s off), with patient-selected stimulation intensity to cause visible contractions below pain threshold. NMES sessions will occur 5 d/week, twice daily for 45 min (5 min warm-up) for 5 wks.
15977990|NCT03051958|Behavioral|Internet mindfulness&exposure treatment|"See description under Arm."
15977991|NCT03051958|Other|Treatment as usual|Written information about standard treatment for atopic dermatitis, that is information regarding how to use moisturizers and anti-inflammatory treatment such as Topical steroids.
15977992|NCT03051945|Drug|Ketamine Hydrochloride|Study drug will be infused while the participant sits or lies in a comfortable position. The dose of ketamine used does not cause unconsciousness but may cause perceptual disturbances.
15977993|NCT03051945|Other|Normal saline|Placebo
15977994|NCT03051932|Drug|Ofiramev® (IV Acetaminophen)|Post -op pain medication
15977995|NCT03051932|Drug|Placebo IV administration|Post -op pain
15977996|NCT03051919|Other|observation|
15977997|NCT03051906|Biological|Durvalumab|Durvalumab given intravenously at 1500 mg every 4 weeks; first two cycles concurrent with RT + cetuximab, 6 cycles after the end of RT as adjuvant treatment; treatment will be continued for a maximum of 8 months (concurrent phase included).
15977998|NCT03051906|Biological|Cetuximab|Cetuximab given intravenously weekly at 400mg/m2 loading dose 1 week before RT start, then 250 mg/m2 weekly thereafter.
15978001|NCT03051880|Drug|Repair Control EGF®|"A Split face study was done. Patients applied 1 finger tip unit of EGF cream on one side of face, twice a day for 8 weeks. Also, to evaluate the preventive effect of paronychia, patients applied same cream on the finger tips of one side hand, twice a day for 8 weeks.
~EGF cream(Repair Control EGF®) containing 10 ppm of rhEGF was prepared at D.N. Co., Ltd. (Seoul, South Korea)"
15978002|NCT03051880|Drug|Cream without rhEGF|"A Split face study was done. Patients applied 1 finger tip unit of cream on the other side of face, twice a day for 8 weeks. Patients applied same cream on the finger tips of the other side hand, twice a day for 8 weeks.
~Placebo cream was prepared at at D.N. Co., Ltd. (Seoul, South Korea), consisted of same ingredient with EGF cream except rhEGF"
15978003|NCT03051854|Behavioral|Interaction Competencies with children - for teachers|Core training components include teacher-student interaction, maltreatment prevention, effective discipline strategies, identifying and supporting burdened students and implementation of the training materials into the school setting.
15978004|NCT03051841|Drug|CKD-581|Intravenously on Days 1, 8 of each 21-day treatment cycle.
15978005|NCT03051828|Procedure|fencing|No intervention: practice fencing
15978006|NCT03051802|Device|Navigated Endoscopy|Navigated endoscopy used to guide the placement of HDR applicators in the esophagus or lung as a replacement to current standard of practice using fluoroscopic imaging.
15978007|NCT03051789|Device|Menstrual Cup|Menstrual cups are reusable bell-shaped receptacles made of high grade medical silicone which collect ~30 ml of menstrual blood when inserted into the vaginal canal
15978008|NCT03051789|Other|Cash transfer|A small stipend of Ksh 1500 (US$15, Dec15 exch) per term will be provided to girls, through a safe and secure mobile money transfer system provider, like M-Pesa, Equity, or Postbank. Monies will be transferred at the beginning of a term, based on school registry statistics confirming participants attended for at least 80% of the previous term.
15978009|NCT03051789|Other|Cups and Cash|Combination of both interventions, using the same interventions and implementation methods.
15978010|NCT03051776|Other|Kinesio Taping|
15978011|NCT03051776|Other|Compression Garment|
15978012|NCT03051750|Other|Complex Physical Therapy plus Pressotherapy|
15978013|NCT03051750|Other|Kinesio Taping|
15978014|NCT03051724|Other|Telematic follow up|Follow-up of OSA patients through automatic CPAP with data transmission (Dreamstation; Philips Respironics), a 24-hour voice mailbox available for questions or problems, and an Internet-connected (4G) tablet with a friendly mobile application for simple questionnaires.
15978015|NCT03051711|Drug|GBT440|Capsules which contain GBT440 drug substance in Swedish Orange
15978016|NCT03051698|Drug|C1-inhibitor|100 Unit/kg IV, one gift prior to broncho provocation.
15978017|NCT03051698|Other|Saline|0.9% NaCl
15978018|NCT03051698|Drug|Antibiotics|vancomycin, ciprofloxacin, metronidazole
15978019|NCT03051685|Drug|DFN-15 Dose 1|
15978020|NCT03051685|Drug|DFN-15 Dose 2|
15978021|NCT03051685|Drug|DFN-15 Dose 3|
15978022|NCT03051685|Drug|Active Comparator|
15978023|NCT03051672|Drug|Pembrolizumab|Pembrolizumab (formerly MK-3475) is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD1 and its ligands, PD-L1 and PD-L2.
15978024|NCT03051672|Radiation|Palliative radiotherapy|Palliative radiotherapy aims to shrink cancer, slow down its growth or control symptoms.
15978025|NCT03051659|Drug|Eribulin Mesylate|Eribulin mesylate is developed from a natural substance found in a sea sponge. Eribulin mesylate works by preventing cancer cells from multiplying
15978026|NCT03051659|Drug|Pembrolizumab|Pembrolizumab binds to PD-1, an inhibitory signaling receptor expressed on the surface of activated T cells, and blocks the binding to and activation of PD-1 by its ligands, which results in the activation of T-cell-mediated immune responses against tumor cells.
15978027|NCT03051646|Drug|Acetylsalicylic acid at 1st visit, then Placebo at 2nd visit|650 mg dose of acetylsalicylic acid is administered in a capsule one hour prior to exercise; Placebo oral capsule is administered one hour prior to exercise
15978028|NCT03051646|Drug|Placebo at 1st visit, then Acetylsalicylic acid at 2nd visit|Placebo oral capsule is administered one hour prior to exercise; 650 mg dose of acetylsalicylic acid is administered in a capsule one hour prior to exercise
15978029|NCT03051633|Behavioral|Be Under Your Own Influence|School based anti-drug use communications campaign
15978030|NCT03051620|Drug|Discontinue alendronate|136 patients with osteoporosis stopping treatment with alendronate.
15978031|NCT03051607|Drug|Tozadenant|1 Year Open Label, 120 mg BID tozadenant, with dose modification to 60 mg BID tozadenant permitted.
15978032|NCT03051594|Device|fluorescent camera|used too detect residual caries depending on the bacterial byproducts.
15978033|NCT03051594|Other|caries detector dye|dye used to detect the residual caries.
15978034|NCT03051594|Diagnostic Test|visual tactile assessment|method usually used to detect the residual caries.
15978035|NCT03051581|Device|18F-FDG PET/ CT|18F-FDG PET/CT will be conducted before, during and after chemotherapy. Patients were instructed to fast for at least 6 h before PET. The blood glucose level was measured to ensure that it was <200 mg/dL. 18F-FDG was intravenously administered at a dose of 3.7 MBq/kg. Approximately 60 ± 10 min post injection, a whole-body acquisition commenced in 6-8 bed positions (1 min/bed) using a hybrid system (PHILIPS Gemini TF) and covered from the base of the skull to the upper thigh, which was followed by CT in a non-contrast phase (modulated 100 mAs; 120 kV; slice thickness, 3 mm) for attenuation correction and anatomical localization purposes. The head acquisition was performed in one bed position (8-10min/bed).
15978036|NCT03051568|Device|18F-FDG PET/CT|18F-FDG PET/CT will be conducted before, during and after chemotherapy. Patients were instructed to fast for at least 6 h before PET. The blood glucose level was measured to ensure that it was <200 mg/dL. 18F-FDG was intravenously administered at a dose of 3.7 MBq/kg. Approximately 60 ± 10 min post injection, a whole-body acquisition commenced in 6-8 bed positions (1 min/bed) using a hybrid system (PHILIPS Gemini TF) and covered from the base of the skull to the upper thigh, which was followed by CT in a non-contrast phase (modulated 100 mAs; 120 kV; slice thickness, 3 mm) for attenuation correction and anatomical localization purposes. The head acquisition was performed in one bed position (8-10 min/bed).
15978073|NCT03051295|Other|Dental health information form|The format in which dentists receive information about diagnostic test results and efficacy of treatment.
15978037|NCT03051555|Device|18F-FDG PET/ CT|18F-FDG PET/CT will be conducted before, during and after chemotherapy. Patients were instructed to fast for at least 6 h before PET. The blood glucose level was measured to ensure that it was <200 mg/ dL. 18F-FDG was intravenously administered at a dose of 3.7 MBq/kg. Approximately 60 ± 10 min post injection, a whole-body acquisition commenced in 6-8 bed positions (1 min/bed) using a hybrid system (PHILIPS Gemini TF) and covered from the base of the skull to the upper thigh, which was followed by CT in a non-contrast phase (modulated 100 mAs; 120 kV; slice thickness, 3 mm) for attenuation correction and anatomical localization purposes. The head acquisition was performed in one bed position (8-10min/bed).
15978038|NCT03051542|Device|18F-FDG PET/CT|18F-FDG PET/CT will be conducted before, during and after chemotherapy. Patients were instructed to fast for at least 6 h before PET. The blood glucose level was measured to ensure that it was <200 mg/￼￼￼￼dL. 18F-FDG was intravenously administered at a dose of 3.7 MBq/kg. Approximately 60 ± 10 min post injection, a whole-body acquisition commenced in 6-8 bed positions (1 min/bed) using a hybrid system (PHILIPS Gemini TF) and covered from the base of the skull to the upper thigh, which was followed by CT in a non-contrast phase (modulated 100 mAs; 120 kV; slice thickness, 3 mm) for attenuation correction and anatomical localization purposes. The head acquisition was performed in one bed position (8-10 min/bed).
15978039|NCT03051529|Other|combined spinal epidural anesthesia|After approval by local research ethics committee of the Faculty of Medicine, and informed written consent obtained from all patients, 24 patients having dilated cardiomyopathy, subjected to vascular surgery in the lower half of the body under CSEA
15978040|NCT03051516|Other|Laboratory Biomarker Analysis|Correlative studies
15978041|NCT03051516|Other|Placebo Administration|Given IM
15978042|NCT03051516|Other|Questionnaire Administration|Ancillary studies
15978043|NCT03051516|Biological|Recombinant Human Papillomavirus Nonavalent Vaccine|Given IM
15978044|NCT03051503|Drug|The Transdermal Therapeutic System-Fentanyl (TTS-F)|(TTS-F) group (n=30) 50ug/h patch, placed 12 hours preoperatively
15978045|NCT03051503|Device|Intravenous patient-controlled analgesia (PCA) morphine|IV PCA morphine for pain in the postoperative period.
15978046|NCT03051490|Drug|Liprotamase|oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement
15978047|NCT03051490|Drug|porcine PERT|oral, enterically-coated, pig-derived, pancreatic enzyme replacement
15978048|NCT03051477|Drug|Helixor® M|3-hour IV infusion on Monday, Wednesday, and Friday of each week.
15978049|NCT03051464|Procedure|Complete responders and Non-complete responders|Patients that are complete responders will not have surgery. Patients that are non-complete responders will have surgery.
15978050|NCT03051464|Radiation|Chemoradiation + EBRT Boost|45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and an external beam boost of 9 Gy in 5
15978051|NCT03051464|Radiation|Chemoradiation + HDRBT Boost|45 Gy in 25 with concomitant 5-FU or Xeloda chemotherapy) and followed by a brachytherapy boost of 30 Gy in 3 fractions
15978052|NCT03051451|Drug|combination metformin hydrochloride/ fluoxetine 500/20 mg|"Group A will receive metformin 1000 mg and 40 mg of fluoxetine; after the increment phase.
~All treatment groups will receive, in addition to the intervention, recommendations of a diet based on a hyper protein, hypo caloric and low carbohydrate diet as well as an exercise routine according to age and physical condition"
15978053|NCT03051451|Drug|combination metformin hydrochloride/ fluoxetine 1000/20mg|"Group B will receive metformin 1700 mg and 40 mg of fluoxetine; after the increment phase.
~All treatment groups will receive, in addition to the intervention, recommendations of a diet based on a hyper protein, hypo caloric and low carbohydrate diet as well as an exercise routine according to age and physical condition"
15978054|NCT03051451|Drug|Placebo Oral Tablet|Group C will receive placebo oral tablet; All treatment groups will receive, in addition to the intervention, recommendations of a diet based on a hyper protein, hypo caloric and low carbohydrate diet as well as an exercise routine according to age and physical condition
15978055|NCT03051438|Procedure|Subxiphoid uniportal VATS|Patients were placed in a supine position, and the operating table was manipulated as needed to elevate the appropriate side of the body for surgery. The surgical procedures followed principles of pulmonary resections; in particular, similar to mediastinal lymphadenectomy for lung cancer, these procedures involved the individual dissection of veins, arteries and lobar bronchi.
15978056|NCT03051438|Procedure|Three-port VATS|The surgical procedures followed principles of pulmonary resections; in particular, similar to mediastinal lymphadenectomy for lung cancer, these procedures involved the individual dissection of veins, arteries and lobar bronchi
15978057|NCT03051425|Dietary Supplement|Probiotic yogurt|120 mL of Yogurt containing Lactobacillus delbrueckii subsp. bulgaricus, Streptococcus thermophilus, Lactobacillus casei, Bifidobacterium animalis ssp. lactis, and Lactobacillus plantarum
15978058|NCT03051425|Dietary Supplement|Placebo|120 mL of low-fat milk
15978059|NCT03051412|Other|No Intervention|No intervention
15978060|NCT03051399|Dietary Supplement|Placebo|The participants will be asked to orally ingest one capsule per day (500 mg maltodextrin, single serving), in combination with 200mL water.
15978061|NCT03051399|Dietary Supplement|EpiCor|The participants will be asked to orally ingest one capsule per day (500 mg EpiCor, single serving), in combination with 200mL water.
15978062|NCT03051386|Biological|VEE Vaccine|0.5 mL of VEE vaccine administered subcutaneously in the upper outer aspect of the triceps region.
15978063|NCT03051373|Drug|nanoparticle albumin-bound paclitaxel, S-1|Nanoparticle albumin-bound paclitaxel is given at 120mg/m2 intravenously over 30 minutes on day 1 and 8, in combination with S-1 which is orally administered (40-60 mg according to the body surface, Bid) on day 1-14 of each 21-days cycle. Number of cycle: 6 cycles.
15978064|NCT03051373|Drug|Gemcitabine, cisplatin|Gemcitabine is given at 1000mg/m2 combination with cisplatin 75mg/m2 intravenously on day 1 and 8 of each 21-days cycle. Number of cycle: 6 cycles.
15978065|NCT03051360|Drug|PCSK9 Inhibitor [EPC]|Patients will receive PCSK9 inhibitor by a biweekly injection
15978066|NCT03051360|Drug|Placebos|Patients will receive Placebo by a biweekly injection
15978067|NCT03051347|Other|Itch Questionnaire and Interview|
15978068|NCT03051347|Other|Stigma Questionnaire and Interview|
15978069|NCT03051347|Other|Cognitive Interview and PROMIS Itch Questionnaire|
15978070|NCT03051334|Other|diagnosed as bicuspid aortic valve|
15978071|NCT03051321|Device|Wellness toilet system|Water-based toileting with capacity to apply zinc oxide barrier spray to treat incontinence associated dermatitis
15978075|NCT03051269|Drug|Calcium chloride|Tumour site is injected with a solution of 9 mg/ml calcium chloride and afterwards the tumour site is given electroporation to facilitate calcium to enter the cell cytosol.
15978076|NCT03051269|Device|Electroporation|"Performed by single use electrodes attaches to a device called Cliniporator provided from IGEA, ITALY."
15978077|NCT03051256|Drug|REL-1017|REL-1017 will be administered as an oral solution. Patients will continue to take the same, stabilized antidepressant medication that they were taking at screening throughout the course of the study.
15978078|NCT03051256|Drug|Placebo|Placebo will be administered as an oral solution. Patients will continue to take the same, stabilized antidepressant medication that they were taking at screening throughout the course of the study.
15978079|NCT03051243|Drug|Linagliptin and Basal Insulin|Linagliptin and bed time insulin glargine linagliptin (trajenta) once daily combined with bed time basal insulin (glargine Lantus; sanofi) before meals
15978080|NCT03051243|Drug|Basal Insulin and Bolus Insulin|Basal bolus insulin regimen and insulin based therapy with glargine once daily before bedtime and glulisine (Apidra; sanofi) before meals
15978081|NCT03051217|Other|Placebo|"Pharmaceutical Form: Solution for injection in pre-filled syringe
~Concentration: 0.9 % saline
~Route of Administration: Subcutaneous use Q2W"
15978082|NCT03051217|Drug|Certolizumab Pegol|"Pharmaceutical Form: Solution for injection in pre-filled syringe
~Concentration: 200 mg/mL
~Route of Administration: Subcutaneous use"
15978083|NCT03051191|Diagnostic Test|micro RNA|micro RNA, cell free DNA and 16S rRNA genes will be explored cross-sectionally at enrollment.
15978084|NCT03051178|Device|Responsive deep brain stimulation|Responsive deep brain stimulation (R-DBS) therapy will be delivered responsively based on the level of their symptoms as detected by wearable EMG and inertia (acceleration) sensors.
15978085|NCT03051165|Device|Hypoglossal Nerve Stimulation Treatment Withdrawal|After 90 days of hypoglossal nerve stimulation (HGNS), therapy will be discontinued for 30 days before being reactivated.
15978086|NCT03051152|Procedure|D1 gastrectomy|Gastrectomy with limited lymph node dissection
15978087|NCT03051152|Procedure|D2 gastrectomy|Gastrectomy with extended lymph node dissection
15978088|NCT03051139|Behavioral|Multi-component LTVV implementation strategy|Multicomponent LTVV implementation strategy consisting of: 1) physician orientation, 2) physician audit and feedback, and 3) clinical decision support comprised of a) an ARDS screening tool using a natural language processing (NLP) algorithm, b) EHR-based tasks for clinicians to complete, and c) a clinician reminder system.
15978089|NCT03051126|Other|Tissue Samples|Fresh residual tissue samples will be obtained during parathyroid and/or pancreas tumor intervention (for pancreas tumor intervention in MEN1 patients with hyperparathyroidism and pancreatic lesions).
15978090|NCT03051100|Drug|Bempedoic acid 180mg|bempedoic acid 180 mg
15978091|NCT03051100|Drug|Ezetimibe 10mg|ezetimibe 10 mg
15978092|NCT03051100|Drug|Atorvastatin 20mg|atorvastatin 20 mg
15978093|NCT03051100|Other|Placebo|placebo
15978094|NCT03051087|Drug|Ganirelix acetate|
15978095|NCT03051074|Behavioral|Floating|Floating supine in a pool saturated with Epsom salt for up to 90 minutes
15978096|NCT03051074|Behavioral|Comparison|Watching a relaxing film for up to 90 minutes
15978097|NCT03051048|Procedure|Reperfusion|
15978098|NCT03051035|Drug|KO-947|Intravenous administration
15978099|NCT03051022|Drug|Dexamethasone 8 mg|Dexamethasone 8 mg was given via epidural catheter as an adjuvant to 12.5 mg of 0.125% bupivacaine in 10 cc syringe and added with 0.9% sodium chloride until the volume was 10 cc.
15978100|NCT03051022|Drug|Morphine 2 mg|Morphine 2 mg was given via epidural catheter as an adjuvant to 12.5 mg of 0.125% bupivacaine in 10 cc syringe and added with 0.9% sodium chloride until the volume was 10 cc.
15978101|NCT03051009|Drug|Desmopressin ODT 25 μg|
15978102|NCT03051009|Drug|Desmopressin ODT 50 μg|
15978103|NCT03050996|Procedure|robotic radical prostatectomy|Urodynamic evaluation during robotic radical prostatectomy
15978104|NCT03050983|Device|IPI|Enable the IPI algorithm and IPI alarm algorithm
15978105|NCT03050957|Dietary Supplement|menthol|Alimentary bolus supplemented with menthol
15978106|NCT03050944|Other|Lifestyle behaviour and dietary habits assessment|Lifestyle behaviour and dietary habits assessment
15978107|NCT03050931|Device|Electrical Impedance Tomography|EIT comprises of a box of electronics similar in size to a video recorder, laptop computer and leads which link typically to 16 or 32 external ECG-like electrodes placed around the subject. Images are generated by applying tiny electrical signals through some electrodes and recording the resulting signals at others. The signals applied are completely safe, within established British and EU safety limits and cannot be felt. For intracranial electrode studies, the EIT systems will be linked to the existing EEG video recording systems and EIT will be recorded at the same time using some or all of the available intracranial electrodes.
15978108|NCT03050918|Behavioral|Follow-up Phone Call|Patients will receive a first call attempt within 72 hours discharge.
15978109|NCT03050905|Drug|VEKIRAX|"Patients will be treated according to label recommendation as for GT1b (with and without cirrhosis) for 12 weeks. All subjects will receive Ombitasvir+Paritaprevir+Ritonavir (Viekirax).
~Study Regimen: ombitasvir+paritaprevir+ritonavir (25+150+100mg once daily)"
15978110|NCT03050905|Drug|EXVIERA|"Patients will be treated according to label recommendation as for GT1b (with and without cirrhosis) for 12 weeks. All subjects will receive Dasabuvir (Exviera).
~Study Regimen: dasabuvir (250 mg twice daily)"
15978111|NCT03050879|Drug|Indocyanine Green Tracer|Laparoscopic gastrectomy with lymph node dissection for gastric cancer using Indocyanine Green Tracer
15978112|NCT03050866|Drug|Cabazitaxel|25mg/m2 q3w
15978113|NCT03050866|Other|Antihistamine|As intravenous premedication (dexchlorpheniramine 5 mg, diphenhydramine 25 mg, or equivalent)
15978114|NCT03050866|Other|Corticosteroid|As intravenous premedication (dexamethasone 8 mg or equivalent)
15978115|NCT03050866|Other|H2 antagonist|As intravenous premedication (ranitidine or equivalent)
15978116|NCT03050866|Other|Antiemetic|Antiemetic prophylaxis is recommended and can be given orally or intravenously if necessary
15978193|NCT03050359|Drug|Bismuth-Containing Quadruple Therapy|1 g Amoxicillin, 500 mg clarithromycin and 600 mg bismuth potassium citrate/bismuth tripotassium dicitrate, twice daily (BID).
15978504|NCT03048097|Drug|Fluorodeoxyglucose|a radiopharmaceutical used in the medical imaging modality positron emission tomography (PET)
15978117|NCT03050853|Behavioral|E-cigarette|The e-cigarette arm will be provided with 8 weeks of free e-cigarettes based on self-report of regular tobacco use. Participants assigned in this arm will be asked to switch combustible tobacco with e-cigarettes. The appeal of e-cigarettes and health impacts will be measured, but we are not targeting quitting combustible tobacco or reducing craving.
15978118|NCT03050840|Behavioral|Way to Health|An online platform (Way to Health) will be used to test if self-monitoring plus gamification principles can increase steps per day and lower sugar sweetened beverage consumption per day, among obese children and adults, compared to self-monitoring alone.
15978119|NCT03050827|Drug|3% oxybutynin|Topical Gelnique 3%TM (3% oxybutynin) applied daily for 20 weeks in type 2 diabetic subjects with established peripheral neuropathy. Subjects will be randomized into placebo or active drug arms and instructed in how to apply 84 mg Gelnique 3%TM or hydrogel placebo to cover a 2 by 2 region of skin adjacent to the initial biopsy site. Treatment will continue daily for 20 weeks, with monthly phone calls to monitor compliance.
15978120|NCT03050827|Drug|Placebo|Non-active placebo for 3% oxybutynin
15978121|NCT03050814|Drug|Avelumab|10 mg/kg IV over 30-60 min on Day 1
15978122|NCT03050814|Biological|Ad-CEA vaccine|Subcutaneous injection in the thigh prior to Avelumab on Day 1 of cycles 1, 2 3, 5, 7, 9; every 6 cycles thereafter.
15978123|NCT03050814|Drug|Bevacizumab|5mg/kg IV over 30-90 min on day 1 (Arm A) or 2 (Arm B). Part of the standard of care therapy.
15978124|NCT03050814|Drug|5-FU|400mg/m2 (only Arm A) IV bolus on day 1. Part of the standard of care therapy.
15978125|NCT03050814|Drug|Leucovorin|400mg/m2 IV over 2 hours on day 1 (Arm A) or Day 2 (Arm B). Part of the standard of care therapy.
15978126|NCT03050814|Drug|Oxaliplatin|85mg/m2 (Arm A) or 68mg/m2 (Arm B) IV over 2 hours on day 1 (Arm A) or Day 2 (Arm B). Part of the standard of care therapy.
15978127|NCT03050814|Drug|Capecitabine|625 mg/m2 twice a day by mouth. Part of the standard of care therapy.
15978128|NCT03050814|Drug|5-FU|2400 mg/m2 (Arm A and B) IV over 46 hours (+/-2 hours) to start on Day 1 (ARM A) or Day 2 (Arm B). Part of the stanard of care therapy.
15978129|NCT03050801|Device|rTMS|Altering the connectivity of trans-synaptic pathways
15978130|NCT03050788|Device|Smartphone confocal microscopy|Imaging of skin lesion using the smartphone confocal microscopy
15978131|NCT03050775|Device|Heated Ventilator Circuit|active heat and humidification during anesthesia by warming inspire gases without a heat-moisture exchanger
15978132|NCT03050775|Device|Standard Ventilator Circuit|no active heat and humidification during anesthesia
15978133|NCT03050762|Other|Data Collection|Participant information collected from either source document or direct participant response.
15978134|NCT03050762|Behavioral|Follow Up|Participants followed up at the return to clinic visits. If participant cannot come to clinic, either a questionnaire mailed requesting follow-up, or participant called. Participants followed for a length of 15 years at intervals of every 2-3 years.
15978135|NCT03050749|Device|Princess® VOLUME|Princess® VOLUME injections up to 10 ml applied to the eligible subjects at the baseline visit, and the touch-up visit, if applicable.
15978136|NCT03050736|Drug|VAL-083 (Dianhydrogalactitol)|VAL-083 given by intravenous infusion with a starting dose of 20 mg/m2 IV. Escalating doses to be administered in sequential dose cohorts.
15978137|NCT03050723|Device|Princess® FILLER|Princess® FILLER injections up to 10 ml applied to the eligible subjects at the baseline visit, and the touch-up visit, if applicable.
15978138|NCT03050710|Device|Princess® VOLUME Lidocaine|Princess® VOLUME Lidocaine injections up to 10 ml given to the patients at baseline, and touch-up at week 2, if applicable
15978139|NCT03050697|Device|HARMONI® Modular Toric Intraocular Lens|Two-component system consisting of a base and a separate toric optic
15978140|NCT03050697|Procedure|Cataract extraction with intraocular lens (IOL) implantation|Cataract removal via manual phacoemulsification, followed by HMTIOL implantation
15978141|NCT03050684|Procedure|vaginal lavage group|vaginal washing will be applied with steril %0.9 NaCl serum (20cc) before intravaginal PGE2 insertion.
15978142|NCT03050684|Procedure|Control Group|vaginal washing will be not applied with steril %0.9 NaCl serum (20cc) before intravaginal PGE2 insertion.
15978143|NCT03050671|Device|Intermittent Pneumatic Compression, Rapid|Cyclic external compression in both calves through a cuff connected to a device which pumps venous blood in a sharp and rapid way
15978144|NCT03050671|Device|Intermittent Pneumatic Compression, Slow|Cyclic external compression in both calves through a cuff connected to a device which pumps venous blood in a smooth, slow and progressive way
15978145|NCT03050632|Behavioral|N-back|The N-back task is a measure of working memory in which individuals need to make a response to targets which are repeated letters either in a row (i.e., one-back) or in every-other-letter format (i.e., two-back).
15978146|NCT03050632|Behavioral|White Bear Task|For this thought suppression task, participants are instructed to inhibit thoughts of a white bear, and to indicate with a pencil mark every time the thought of the white bear occurs to them.
15978147|NCT03050619|Drug|Empagliflozin|
15978148|NCT03050619|Drug|Other SGLT2 inhibitors|
15978149|NCT03050619|Drug|Other non-insulin GLDs|metformin, sulfonylureas, DPP-4 inhibitors, GLP-1 agonists
15978150|NCT03050606|Other|Pilates|Exercises performed on the mat and apparatus, following the six principles of the Pilates method. The exercises will be performed in three levels of difficulty: basic, intermediate and advanced, according to the capacity of the patient.
15978151|NCT03050606|Other|Aerobic|Aerobic exercise will be carried out individually on treadmills or stationary bikes. The intensity of the training will be mild to moderate (57% to 76% of the maximal heart rate monitored by the frequencymeter).
15978152|NCT03050593|Diagnostic Test|MRI scan, Echo scan|
15978153|NCT03050580|Behavioral|self-esteem enhancement group|Subjects in the treatment group will join a six-session treatment for recognizing their strengths and resources through group activities and sharing. Each session is 1.5-2 hours long, and all sessions are designed for 4-8 abused women. The activities are designed and led with an aim to improve their self-esteem, general health, as well as to reduce the level of depression. This service is provided by registered social workers.
15978154|NCT03050580|Behavioral|Standard care for abused women|The shelter standard care and services will be provided to the abused women in one randomized shelter. Besides, standard care in shelters includes residential accommodations, emotional support, legal, housing and financial advice and referrals will be given to survivors who reported being abused.
15978155|NCT03050567|Diagnostic Test|Transcranial Doppler Ultrasound|Transcranial Doppler will be performed on the symptomatic (ipsilateral to an index event) middle cerebral artery in a quiet temperature controlled room. The middle cerebral artery will be identified through the temporal window in a supine position with a flow direction towards the probe. The subject will have a head frame (Marc 600 Spencer Technologies, USA) fitted to reduce motion and to secure a constant angle of the middle cerebral artery insonation depth at 50-60 mm from the skull surface. All recordings will be made using the ST3 Transcranial Doppler Ultrasound System (Spencer Technologies, USA) with a 2-MHz transducer for 1 hour. Emboli will be detected by listening for their characteristic short audible sound (range 10-100 ms, intensity threshold above 7 dB) and spectral appearance using the International Consensus Group microembolus identification criteria and an automated Embolus Detection Software (Spencer Technologies, USA).
15978156|NCT03050554|Drug|Avelumab|Avelumab 10mg/kg IV infusion every 2 weeks for 6 cycles
15978157|NCT03050554|Radiation|SBRT|SBRT: 12Gy x 4 fractions or 10Gy x 5 fractions (4-5 radiation doses given over 10-12 days every other day.)
15978158|NCT03050541|Drug|MDMA|This is a between subjects, double-blind, placebo controlled design. We are administering oral MDMA to healthy volunteers to measure its effects on the encoding, consolidation, and retrieval stages of memory.
15978159|NCT03050541|Drug|Placebo|
15978160|NCT03050528|Behavioral|Supervised Exercise|Participants will attend the weekly supervised exercise sessions for a period of eight weeks. The classes will be delivered to groups of up to ten participants and will be led by a physiotherapist. The classes will be one hour and thirty minutes in duration and will feature two components: education/advice and exercise. The education/advice sessions will cover topics such as pacing and goal setting and the physiotherapist will answer any queries from the participants in relation to physical activity over the course of the eight weeks. The exercise component will involve the provision of individualised exercises based on each participant's personal goals and the sessions will feature a combination of aerobic, stretching and strengthening exercise in a pool and a gym setting.
15978161|NCT03050528|Behavioral|Acceptance and Commitment Therapy|Participants will attend weekly group psychology sessions for an eight-week period. Each session will be two hours in duration and will delivered by a Senior Psychologist trained in Acceptance and Commitment Therapy (ACT). The sessions will feature an ACT treatment process that is designed to promote psychological flexibility through various methods including acceptance and values awareness. The overall aim is to promote behaviour change, enhancing patient engagement in meaningful activities and reducing pain-avoidant behaviours. There is an emphasis on mindfulness, experiential learning and the use of metaphor which is unique to ACT.
15978162|NCT03050515|Biological|Fecal Microbiota Transplantation|This is a single arm study. All participants will receive a single fecal transplant to determine effectiveness in treating refractory recurrent urinary tract infections.
15978163|NCT03050502|Device|Chest tube drain|This group will have an intra-pleural catheter placed with the intent of draining all intra-pleural blood (HTX). The size and nature of the catheter, manner of placement, and timing of removal will be at the discretion of the attending clinician.
15978164|NCT03050502|Other|Expectant management|This group will not have an intra-pleural catheter placed on the basis of the HTX, but will undergo standard observation/conservative management by the trauma service. Intra-pleural catheters may be placed after enrollment at the attending clinician's discretion.
15978165|NCT03050489|Procedure|On-Pump CABG.|Standard On-Pump CABG.
15978166|NCT03050489|Procedure|Off-Pump CABG.|Standard Off-Pump CABG.
15978167|NCT03050489|Procedure|BH-CABG MSC.|Patients with coronary artery bypass graft (CABG) surgery performed on beating heart with mechanical support of circulation
15978168|NCT03050476|Drug|bRESCAP|intravenous application before, during, and for 24 hours after heart surgery
15978169|NCT03050476|Drug|placebo|intravenous application before, during, and for 24 hours after heart surgery
15978170|NCT03050463|Procedure|Biospecimen Collection|Undergo blood and saliva sample collection
15978171|NCT03050463|Procedure|Functional Magnetic Resonance Imaging|Undergo fMRI related tasks
15978172|NCT03050463|Other|Questionnaire Administration|Ancillary studies
15978173|NCT03050450|Drug|25 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)|Drug: Lenalidomide 25 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
15978174|NCT03050450|Drug|50 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)|Drug: Lenalidomide 50 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
15978175|NCT03050450|Drug|100 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)|Drug: Lenalidomide 100 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
15978176|NCT03050450|Drug|150 mg/m2 Lenalidomide (Revlimid®) and 180 mg/m2 Vorinostat (Zolinza®)|Drug: Lenalidomide 150 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 180 mg/m2 days 1-7 and 15-21 of a 28 day cycle
15978177|NCT03050450|Drug|150 mg/m2 Lenalidomide (Revlimid®) and 230 mg/m2 Vorinostat (Zolinza®)|Drug: Lenalidomide 150 mg/m2 days 1-21 of a 28 days cycle Drug: Vorinostat 230 mg/m2 days 1-7 and 15-21 of a 28 day cycle
15978178|NCT03050437|Drug|Cisplatin|cisplatin is added to Pem/cis arm
15978179|NCT03050437|Drug|Pemetrexed|Pem is applied to both arms
15978180|NCT03050424|Drug|Ferric Carboxymaltose|Ferric Carboxymaltose injectable Product
15978181|NCT03050424|Drug|Sodium Chloride 0.9%|Sodium Chloride 0.9%
15978182|NCT03050411|Drug|Apatinib Mesylate Tablets|250mg, 500mg, 750mg, q.d., p.o.
15978183|NCT03050411|Drug|EGFR-TKIs (Erlotinib, Gefitinib and Osimertinib)|EGFR-TKIs include but are not limited erlotinib, gefitinib and osimertinib
15978184|NCT03050398|Drug|Ribociclib|ribociclib + letrozole
15978185|NCT03050398|Drug|letrozole|ribociclib + letrozole
15978186|NCT03050385|Device|transcranial direct current stimulation|
15978187|NCT03050372|Device|LFMS - Active|A non-invasive form of brain stimulation administered from a device resembling a bird cage. The device covers the top part of the head for the duration of stimulation (in the current study, 20 minutes)
15978188|NCT03050372|Device|LFMS - Sham|A simulation of the LFMS-Active intervention, using the same device that produces a sound similar to the sound made by the device during the active treatment, for a similar duration (in the current study, 20 minutes)
15978189|NCT03050359|Drug|TAK-438|TAK-438 tablets
15978190|NCT03050359|Drug|Lansoprazole|Lansoprazole capsules
15978194|NCT03050320|Other|Exercise|A biomechanical exercise program shown to decrease joint loading will be administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
15978195|NCT03050320|Other|No Exercise|A no exercise (control) group will be asked to maintain their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
15978196|NCT03050307|Drug|TAK-438|TAK-438 tablets
15978197|NCT03050307|Drug|Lansoprazole|Lansoprazole capsules
15978198|NCT03050307|Drug|TAK-438 Placebo|TAK-438 placebo-matching tablets
15978199|NCT03050307|Drug|Lansoprazole Placebo|Lansoprazole placebo-matching capsules
15978200|NCT03050307|Drug|Bismuth-Containing Quadruple Therapy|1 g Amoxicillin, 500 mg clarithromycin and 600 mg bismuth potassium citrate/bismuth tripotassium dicitrate, twice daily (BID).
15978201|NCT03050294|Behavioral|Phone calls|Phone calls twice daily
15978202|NCT03050294|Drug|Desoximetasone 0.25% spray|Desoximetasone 0.25% spray applied twice daily
15978203|NCT03050281|Other|Simulation/Cadaver lab|The primary focus of this study is to determine whether the use of a comprehensive, combined, and simplified approach of using cadavers and simulation laboratories to train third-year medical students will have a beneficial effect on student performance in the OB-GYN and surgical clerkships.
15978204|NCT03050281|Other|Lectures|Standard Anatomy lectures were offered.
15978205|NCT03050255|Other|Medical air|
15978206|NCT03050255|Other|Oxygen (2Liter/min)|
15978207|NCT03050255|Other|Oxygen (4Liter/min)|
15978208|NCT03050242|Drug|Glycopyrrolate|Intramuscular administration of glycopyrrolate 0.005mg/kg 1 hour before the surgery
15978209|NCT03050229|Drug|Empagliflozin|Empagliflozin 10mg/day once daily before or after breakfast
15978210|NCT03050229|Drug|Placebo|Placebo once daily before or after breakfast
15978211|NCT03050216|Biological|ALT-803|"Preparative Regimen:
~Fludarabine 25 mg/m2 x 5 days start day -6 Cyclophosphamide 60 mg/kg x 2 days on day -5 and -4
~ALT-803 Stimulated Donor NK Cells:
~The apheresis product (collected day -1) will be enriched for NK cells with the large-scale CliniMacs® device (Miltenyi) by depletion of CD3+ cells to remove T-lymphocytes and depletion of CD19+ cells to remove B-lymphocytes. The NK cell enriched product will be stimulated by overnight incubation with 36.1 ng/mL ALT-803 under GMP conditions and infused on day 0.
~ALT-803 to Facilitate NK Cell Survival and Expansion:
~ALT-803 at 10 mcg/kg subcutaneously (SC) with the 1st dose administered on day 0 (no sooner than 4 hours post NK cells), day +5 and day +10 for 3 doses total"
15978212|NCT03050203|Other|custom pack|Preparation of the surgical field using a custom pack. The use of a custom pack provides much of the material provided for the preparation of the surgical field with a single opening of the package , reducing the risk of contamination of the material.
15978213|NCT03050203|Other|standard care|The scrub nurse prepares the surgical field opening all the sterile packs it deems necessary for the surgery
15978214|NCT03050190|Genetic|Therapeutic 4SCAR19 cells|Autologous 4th generation withdrawal lentiviral-transduced 4S CAR-T19
15978215|NCT03050177|Drug|Gefitinib Tablet 250mg of Hunan Kelun|Single dose of Gefitinib Tablet 250mg of Hunan Kelun was administered under fed conditions after a 10-hour overnight fast.
15978216|NCT03050177|Drug|Iressa® Tablet 250mg of AZN|Single dose of Iressa® Tablet 250mg of AZN was administered under fed conditions after a 10-hour overnight fast.
15978217|NCT03050164|Drug|Gefitinib Tablet 250mg of Hunan Kelun|Single dose of Gefitinib Tablet 250mg of Hunan Kelun was administered after a 10-hour overnight fast.
15978218|NCT03050164|Drug|Iressa® Tablet 250mg of AZN|Single dose of Iressa® Tablet 250mg of AZN was administered after a 10-hour overnight fast.
15978219|NCT03050151|Drug|Dupilumab|Administration of dose of Dupilumab as per protocol by auto-injector or prefilled syringe
15978220|NCT03050151|Device|Auto-injector Device|Delivery of Dupilumab by auto-injector device
15978221|NCT03050151|Device|Prefilled syringe|Delivery of Dupilumab by prefilled syringe
15978222|NCT03050125|Device|Hypo-osmolar drop 1|180 mOsmol sterile saline drops used as a contact lens rewetting drop.
15978223|NCT03050125|Device|Hypo-osmolar drop 2|240 mOsmol sterile saline drops used as a contact lens rewetting drop.
15978224|NCT03050125|Device|Iso-osmolar drop|300 mOsmol sterile saline drops used as a contact lens rewetting drop.
15978225|NCT03050112|Other|MacNew questionnaire|Patients will be asked to fill in the MacNew questionnaire on quality of life (phone contact).
15978226|NCT03050099|Other|Non-Interventional Study|This is a non-interventional study. However, several blood samples will be taken which would not be taken as part of standard of care.
15978227|NCT03050086|Drug|BPX-04 1% minocycline topical gel|once daily administration of topical minocycline gel to face
15978228|NCT03050086|Drug|BPX-04 2% minocycline topical gel|once daily administration of topical minocycline gel to face
15978229|NCT03050086|Drug|BPX-04 vehicle topical gel|once daily administration of topical minocycline gel to face
15978230|NCT03050060|Drug|Atezolizumab|Given IV
15978231|NCT03050060|Radiation|Hypofractionated Radiation Therapy|Undergo hypofractionated radiation therapy
15978232|NCT03050060|Other|Laboratory Biomarker Analysis|Correlative studies
15978233|NCT03050060|Drug|Nelfinavir Mesylate|Given PO
15978234|NCT03050060|Biological|Nivolumab|Given IV
15978235|NCT03050060|Biological|Pembrolizumab|Given IV
15978236|NCT03050047|Biological|BCD-100|Anti-PD1 monoclonal antibody
15978237|NCT03050034|Device|WIN @ Hospital system|WIN @ Hospital system is a wearable and wireless system (Medical Class IIA) that allows continuous and real-time vital signs monitoring, automatically calculating the NEWS score with a personalized alert system for the patient. It does not require the continuous presence of the nurse in front of the control room, but is working with alert on portable devices (ipad).
15978238|NCT03050034|Other|Traditional monitoring|Vital signs control performed by nurse staff each 6 hours or more, according to medical advice.
15978239|NCT03050008|Other|FLACS USFREE|Cataract Surgery with Femtosecond Laser Without Ultrasound
15978240|NCT03050008|Other|Traditional Surgery|Traditional phacoemulsification cataract surgery using ultrasound.
15978241|NCT03049995|Procedure|Left ventricular contractile reserve SE|Stress protocols (either physical or pharmacological) will be performed according to recent guidelines recommendations (1,2,3). with special focus on Wall Motion Score Index.
15978242|NCT03049995|Procedure|B-lines SE|SE will be performed with special focus on lung sonography and B-lines score (3,4).B-lines will be scored with the 28-regions antero-lateral chest assessment as previously described at baseline and immediately after stopping exercise. A simplified 8-region scan is also allowed in order to save time without loss of critical information.
15978243|NCT03049995|Procedure|Left ventricular outflow tract gradient SE|SE will be performed with special focus on left ventricular outflow tract obstruction (3,4).
15978244|NCT03049995|Procedure|Diastolic function SE|SE will be performed with special focus on E/e', pulmonary artery systolic pressure, B-lines and left ventricular end-diastolic volume (3,4).
15978245|NCT03049995|Procedure|Mitral regurgitation SE|SE will be performed with special focus on mitral regurgitation and aortic valve gradients assessment (3,4).
15978246|NCT03049995|Procedure|Pulmonary hemodynamics SE|SE will be performed with special focus on pulmonary artery systolic pressure and pulmonary artery hemodynamics.
15978247|NCT03049995|Procedure|Coronary flow reserve SE|SE will be performed with special focus on regional wall motion + coronary artery flow velocity reserve.
15978248|NCT03049982|Device|Auto-titrating mandibular positioner test|Participants will undergo a theragnostic test using the auto-titrating mandibular positioner to determine if they are eligible candidates to use oral appliance therapy for their obstructive sleep apnea. The device works by moving the lower jaw forward in response to respiratory events while the participant sleeps. All participants will undergo the same test.
15978249|NCT03049969|Device|tDCS stimulation|up to 4.0 mA, dorsolateral prefrontal cortex (montage dependent on specific area of deficit) while completing cognitive training tasks
15978250|NCT03049956|Diagnostic Test|Ocular vestibular evoced myogenic potentials|The oVEMP technique is an accepted standard for testing otolith function in vestibular patients. It represents a quick, simple and non-invasive technique utilizing repetitive stimulation of the otolith organs with bone-conducted vibration to elicit an extraocular muscle response. Repetitive oVEMP stimulation leads to a characteristic decrement in patients with myasthenia, which can be quantified with surface electromyography from the inferior oblique muscle underneath the eye.
15978251|NCT03049943|Device|low level laser|
15978252|NCT03049930|Drug|Ketamine|Ketamine is a medication used for starting and maintaining anesthesia. Participants randomized to the ketamine arm will receive 1 mg/ml solution infused at 0.2 mg/kg/hour (0.2 ml/kg/h) for a maximum of 20 ml/hour.
15978253|NCT03049930|Drug|Sodium chloride|Participants randomized to the placebo arm will receive 0.9 mg/ml sodium chloride, infused at a rate of 0.2 ml/kg/hour
15978254|NCT03049917|Behavioral|Financial incentive|Conditional cash transfer upon HIV testing
15978255|NCT03049904|Behavioral|Vr2L 2Spirit|"Three weeks exploring the Vr2L 2Spirit island.
~Week 1: Learning Level. Contains the Vr2L 2Spirit island orientation, the learning paths covering HIV testing, harm reduction, safer sex, and condom use & condom use negotiation, the lodge, the in-world Motivational Interviewing (MI) counseling, and leisure activities.
~Week 2: Skills Building Level. The purpose of the city level is for participants to practice the knowledge gained in the Learning level through quests, challenges, and role play scenarios.
~Week 3: Experiential Level. Experiential interactions with other participants where they can practice the knowledge and skills they gained in the previous levels."
15978256|NCT03049891|Other|Data abstraction|The investigators will abstract clinical data from down-referral sites and from NHLS to determine whether children made it to their down-referral sites or whether children are in care at a different facility.
15978257|NCT03049891|Other|Tracing questionnaire|The investigators will attempt to contact and visit caregivers of children who are determined to be LTF from DNH or from down-referral sites. If located and after providing consent, caregivers will be administered a tracing questionnaire, or a verbal autopsy if their child has died.
15978258|NCT03049891|Other|Tier.net|For all children who started ART at DNH between 2004 and 2013, the investigators will abstract data on these children from the electronic medical system in South Africa called Tier.net.
15978259|NCT03049878|Drug|Paracetamol Codeine|preoperative administration
15978260|NCT03049878|Drug|Placebo Oral Tablet|preoperative administration
15978261|NCT03049852|Drug|CBT-001 single dose|One drop in the study administered one time
15978262|NCT03049852|Drug|Vehicle|One drop in the study administered three times daily (TID) for 4 weeks
15978263|NCT03049852|Drug|CBT-001 Multi-dose|One drop in the study administered three times daily (TID) for 4 weeks
15978264|NCT03049839|Behavioral|Intervention_ S|One year Structured intervention program for members of high-risk group (Subjects with FINDRISC score ≥12 points and impaired glucose tolerance (IGT))
15978265|NCT03049839|Behavioral|Intervention_ I|One year Informative intervention program for members of moderate risk group (People with normotolerant or impaired fasting glucose in the OGTT and a FINDRISC score ≥12 points)
15978266|NCT03049839|Behavioral|Intervention_ C|One year, Intervention program at Community level. People with a FINDRISC less than 12 points
15978267|NCT03049826|Other|Nutritional status|Body composition and nutrient status
15978268|NCT03049813|Behavioral|Virtual Reality Job Interview Training|Job interview training using virtual reality software created by SIMmersion, Inc, in addition to standard supported employment services.
15978269|NCT03049813|Other|Supported Employment (Services as Usual)|Standard supported employment services.
15978270|NCT03049800|Device|Magnetic Resonance Imaging|Functional, structural, and diffusion weighted imaging conducted with a 7T-PS scanner and a Prisma 3T scanner.
15978271|NCT03049787|Other|Home Exercise Protocol|Home exercise therapy protocol given to patient to be completed at home.
15978272|NCT03049787|Other|Physical Therapy Protocol|Formal physical therapy protocol to be given to physical therapist working with patient to direct formal intervention along with a home therapy protocol.
15978273|NCT03049761|Device|Water Flosser|Power interdental cleaner
15978274|NCT03049761|Device|String Floss|Mechanical interdental cleaner
15978275|NCT03049761|Device|Manual Toothbrush|ADA standard soft bristle toothbrush
15978276|NCT03049748|Device|Mobile phone app (VAD Care App)|"VAD Care App is a novel self-management tool being tested for patients with implantable LVADs. The app has daily push notifications (alerts), cues for daily self-management tasks, two-way communication using text messages and videoconferencing (virtual clinic), and links to LVAD self-management skills and videos easily accessible for self-management skill review."
15978505|NCT03048097|Drug|Rubidium|used in PET scans
15978277|NCT03049748|Other|Usual LVAD Care|Routine clinic follow-up visits over 6 months. Patients and caregivers will both receive self-management education post discharge and as needed throughout the duration of the study.
15978278|NCT03049735|Drug|Relugolix|Relugolix (40 mg) tablet administered orally once daily.
15978279|NCT03049735|Drug|Estradiol/norethindrone acetate|E2 (1.0 mg)/NETA (0.5 mg) co-formulated capsule administered orally once daily.
15978280|NCT03049735|Drug|Estradiol/norethindrone acetate placebo|E2 (0 mg)/NETA (0 mg) placebo capsule administered orally once daily and designed to match the capsule containing E2/NETA in size, shape, color, and odor.
15978281|NCT03049735|Drug|Relugolix placebo|Relugolix (0 mg) placebo tablet administered orally once daily and manufactured to match the relugolix tablet in size, shape, color, and odor.
15978282|NCT03049722|Device|Pacemaker|
15978283|NCT03049696|Behavioral|ENCOURAGEING START|16-week physical activity and behaviour modification/education program. CMBS approved bariatric surgery patients participate in structured, supervised physical activity sessions (2 per week) and behaviour modification-education classes during weeks 1 through 8. During weeks 9 through 16, patients will be given access to attend drop in physical activity sessions or can opt to complete physical activity at home.
15978284|NCT03049683|Other|Vestibular evoked myogenic potentials (VEMPs)|The c- and oVEMPs will be assessed in three different sessions including conventional sequential recordings and two different simultaneous recording methods, i.e., unilateral simultaneous recording of cVEMPs and oVEMPs during monaural stimulation (Figure 1A) and bilateral simultaneous recording of each VEMP during binaural stimulation (Figure 1B).
15978285|NCT03049670|Device|latent available chlorine (LAC)|local application on the necrotic infected tissue
15978286|NCT03049657|Device|Angiolite|Percutaneous coronary intervention
15978287|NCT03049657|Device|Xience|Percutaneous coronary intervention
15978288|NCT03049644|Procedure|Mechanical Diagnosis and Therapy|Identification of directional preference.
15978289|NCT03049644|Procedure|Manual Therapy|Mechanically based treatment based on taking joint to end range and thrusting or soft tissue manipulation.
15978290|NCT03049631|Dietary Supplement|Raspberry and fructooligosaccharide|Red raspberries (1 cup equivalent) with fructooligosaccharide (8 g)
15978291|NCT03049631|Dietary Supplement|Raspberry|Red raspberries (1 cup equivalent)
15978292|NCT03049618|Other|Laboratory Biomarker Analysis|Correlative studies
15978293|NCT03049618|Biological|Pembrolizumab|Given IV
15978294|NCT03049618|Biological|Recombinant EphB4-HSA Fusion Protein|Given IV
15978295|NCT03049605|Device|Magnetic therapy|low intensity pulsed magnetic therapy with a frequency of 200 Hertz and intensity of 50 Gauss . Magnetic device will be applied on each patient from a comfortable supine lying position. After the connection of appliance to electrical supply, the actions of PEMF will be directed and adjusted over lumbar spine, hip regions and calf muscles of both lower limbs.
15978296|NCT03049605|Device|laser therapy|laser therapy of Helium neon infrared laser (850 nano-meter) was used in continuous wave mode from a comfortable prone lying position on the whole plantar surface of the foot and the lumbo-sacral area by four points, and two points laterally to the spine.
15978297|NCT03049605|Drug|Only medical treatment|Fifteen patients with diabetic peripheral neuropathy were treated with antidiabtic drugs and lyrica 150 milligram daily
15978298|NCT03049592|Other|HIBISCUS counseling|Third trimester prenatal appointment with a family planning specialist for contraceptive counseling utilizing the Contraceptive CHOICE counseling script - emphasizing the WHO birth-to-pregnancy recommendation of 18 months, and a follow up postpartum contraception visit with a family planning specialist.
15978299|NCT03049579|Dietary Supplement|Weiquan Yogurt with probiotics|150 ml daily consumption for a total of 12 weeks
15978300|NCT03049579|Dietary Supplement|Weiquan Yogurt without probiotics|150 ml daily consumption for a total of 12 weeks
15978301|NCT03049566|Other|preoperative questionnaires|no intervention, cross-sectional survey in a single group
15978302|NCT03049553|Device|Cobas HPV-DNA test|"Cobas HPV-DNA testing device from Roche is already in standard use in the Danish screening program for purpose of triage and primary screening of women 60+. It has four signals; HPV-negative, HPV-16, HPV-18 and other"
15978303|NCT03049540|Drug|Tadalafil 20 MG|Multi-center, double-blind, 1:1 randomized, placebo-controlled clinical trial with Tadalafil
15978304|NCT03049540|Drug|Placebo 20 MG|Multi-center, double-blind, 1:1 randomized, placebo-controlled clinical trial with Tadalafil
15978305|NCT03049527|Behavioral|Education, Incentives and Feedback|The study participants will receive additional educational activities, including low-literacy fact sheets on liquid intake guidelines, cards with instructions on how to self-monitor urine color and volume, and flyers and posters placed throughout the worksite. All consenting study participants will be offered incentives to start the work day hydrated and then to maintain or improve their hydration status over the work shift. Participants who do not meet hydration goals will receive additional coaching and feedback on ways to improve hydration.Feedback will also be provided to all groups about their productivity level to help participants recognize the connection between improved health and function.
15978306|NCT03049501|Behavioral|Caregiving condition|The intervention will consist of multimedia features accessible via the study-provided tablet. The components include: skill-building sessions and modules; a resource guide; an annotated reading list; information and tips; expert educational seminars (video); and structured support group sessions (6 sessions). All the sessions (home-based, one-on-one, and support group sessions) will last about 60-90 minutes.
15978307|NCT03049501|Behavioral|Nutrition condition|The intervention will provide resource and information tips on topics related to Nutrition for a total of 8 sessions. The first and last session will be home-based and all the other sessions will be conducted via web-conferencing using the tablet provided.
15978308|NCT03049488|Biological|VRC-RSVRGP084-00-VP|VRC-RSVRGP084-00-VP is an investigational respiratory syncytial virus (RSV) vaccine.
15978309|NCT03049488|Other|Aluminum Hydroxide Suspension|Aluminum Hydroxide Suspension, alum, is an adjuvant.
15978312|NCT03049449|Biological|Anti-CD30-CAR T cells|Dose-escalation trial starting dose: 0.3x106 CAR+ T cells/kg(weight based dosing)(up to a maximum dose of 18x106 CAR+ T cells/kg)infuse on day 0
15978313|NCT03049449|Drug|Cyclophosphamide|300 or 500 mg/m2 IV infusion over 30 minutes on days -5, -4 and -3
15978314|NCT03049449|Drug|Fludarabine|30 mg/m2 IV infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4,and -3
15978315|NCT03049436|Other|Program of adapted physical activity|
15978316|NCT03049423|Device|MRI scans|30 patients with ankle ligament and tendon injury were selected in accordance with the diagnostic criteria of ankle ligament and tendon injury in the trial group. Each participant was required to undergo MRI scans in normal position and during complete plantar flexion and complete dorsiflexion.
15978317|NCT03049423|Diagnostic Test|MRI scans and general physical examination|30 patients with normal ankle joint were selected in accordance with the diagnostic criteria of ankle ligament and tendon injury in the control group. Each participant was required to undergo MRI scans and general physical examination in normal position and during complete plantar flexion and complete dorsiflexion.
15978318|NCT03049410|Procedure|Intracorporeal Robot Assisted Radical Cystectomy|Intracorporeal robot assisted radical cystoprostatectomy or anterior exenteration
15978319|NCT03049410|Procedure|Open Radical Cystectomy|Removal of bladder and adjacent organs
15978320|NCT03049397|Other|Communication Intervention|Complete Enhancing Connections program
15978321|NCT03049397|Other|Questionnaire Administration|Ancillary studies
15978322|NCT03049384|Other|Traditional Exercise|The traditional exercise group will undertake a supervised exercise intervention involving aerobic exercise and light resistance training, in line with published guidelines for exercise in cancer survivors.
15978323|NCT03049384|Other|Tailored Exercise|The tailored training group will be prescribed an individualized exercise intervention designed specifically to counteract deficits (e.g. neuromuscular) of difficulties (e.g. sleep disturbance) identified during pre-intervention testing.
15978324|NCT03049371|Other|No Intervention for both groups|No Intervention for both groups However, computer-administered questionnaire will collect quantitative demographic information and details about surgical history, neovaginal health, neovaginal practices, and sexual behavior including neovaginal intercourse and drug use history from each participant
15978325|NCT03049358|Other|Physiologic Testing|Undergo UPSIT smell test
15978326|NCT03049358|Other|Quality-of-Life Assessment|Ancillary studies
15978327|NCT03049358|Procedure|Sham Intervention|Undergo sham training
15978328|NCT03049358|Procedure|Therapeutic Procedure|Undergo olfactory training
15978329|NCT03049358|Other|rose essential oil|patient smells rose oil in vial
15978330|NCT03049358|Other|lemon essential oil|patient smells lemon oil in vial
15978331|NCT03049358|Other|clove essential oil|patient smells clove oil in vial
15978332|NCT03049358|Other|eucalyptus essential oil|patient smells eucalyptus oil in vial
15978333|NCT03049358|Other|canola oil placebo|patient smells canola oil in vial
15978334|NCT03049345|Procedure|Sentinel Lymph Node Sampling|The day before surgery, 2mL of endoscopically-placed technetium 99m sulfur colloid solution will be injected submucosally at 4 points around the tumour. At the time of surgery, 2cc of 1% isosulfan blue dye will be similarly injected. Laparoscopically, the gastrocolic ligament will be opened to expose all gastric lymph node drainage basins. Using visual inspection and a laparoscopic gamma probe, blue nodes and those emitting 10x greater than background activity will be considered sentinel nodes and extracted. Sentinel lymph nodes and resected specimens will be analyzed by permanent section.
15978335|NCT03049345|Drug|Radioactive Tracers|see above
15978336|NCT03049345|Drug|Methylene Blue 20 MG/ML|see above
15978337|NCT03049332|Behavioral|self- and family-management intervention sessions|The self- and family management intervention will have six elements: (a) biofeedback for relaxation; (b) family support; (c) coping skills; (d) anxiety, stress, and depression management; (e) cognitive-behavioral management skills; and (f) psycho-educational classes.
15978338|NCT03049319|Device|Psoriashield in the presence of a non-UV absorbing block.|The psoriashield will be applied to patient's back in the presence of a non-UV absorbing block.
15978339|NCT03049319|Device|Psoriashield in the presence of a UV absorbing block.|The psoriashield will be applied to patient's back in the presence of a UV absorbing block.
15978340|NCT03049319|Device|Psoriashield|The psoriashield will be applied to patient's back.
15978341|NCT03049319|Device|Xtrac laser in the presence of a non-UV absorbing block.|The Xtrac laser will be applied to patient's back in the presence of a UV absorbing block.
15978342|NCT03049319|Device|Xtrac in the presence of a UV absorbing block.|The Xtrac laser will be applied to patient's back in the presence of a non-UV absorbing block.
15978343|NCT03049319|Device|Xtrac laser|The Xtrac laser will be applied to patient's back.
15978344|NCT03049306|Drug|Propranolol Oral Tablet|Patients will receive Propranolol LA 80 mg PO at 7 PM before sleep (on CPAP withdrawal nights only)
15978345|NCT03049306|Drug|Placebo Oral Tablet|Patients will receive Placebo tablet at 7 PM before sleep (on CPAP withdrawal nights only)
15978346|NCT03049306|Device|CPAP|Patients will sleep in the lab wearing CPAP
15978347|NCT03049293|Drug|Midazolam|The impact of Midazolam levels in follicular fluid.
15978348|NCT03049280|Device|Transoral robotic surgery|Transoral robotic surgery for T1 & T2 oropharyngeal cancers
15978349|NCT03049267|Drug|Apremilast|Fifteen patients will be supplied of apremilast for daily oral use; 16 weeks.
15978350|NCT03049267|Drug|Placebo Oral Tablet|Five patients will be supplied with placebo tablets with identical labeling as apremilast for daily use; 16 weeks.
15978351|NCT03049241|Other|neuromuscular fatigue|The main aim of the present protocol is to compare the effect of knee extensors and ankle plantarflexors length on the development and aetiology of neuromuscular fatigue, in children and adults
15978385|NCT03049007|Diagnostic Test|Survey|Completion of surveys with diagnostic measurements (e.g., PGD, depression, anxiety, PTSD).
15978469|NCT03048370|Procedure|Right warm CVS|Caloric vestibular stimulation (CVS), which involves the irrigation of cold or warm water into the external ear canal, induces a temperature gradient across the semicircular canals of the vestibular apparatus stimulating the vestibular nerve. It is commonly used in both otolaryngology to assess vestibular function and neurology to test brain stem function
15978352|NCT03049228|Diagnostic Test|31P-MRS scan and cardiac MRI scan|"31P-MRS measurement of the heart: Phosphorous magnetic resonance spectroscopy (31P-MRS) will be used for the determination of the energy status of the heart in vivo. The localization of phosphorus energy metabolites in the heart will be performed by one-dimensional spectroscopic imaging, resulting in spectra from slices through the heart of 1 cm thickness. The peaks of PCr and ATP will be fitted in order to calculate the ATP/PCr ratio.
~The measurement of cardiac function is a standardised protocol. In the 4 chamber view setting a T1 mapping sequence will be performed for the detection of fibrosis. Hereafter patients will receive contrast for T2 mapping and late enhancement studies for determining extracellular volume and ischemia."
15978353|NCT03049228|Diagnostic Test|Atrial biopsy for high-resolution respirometry|Mitochondrial respiration rates are ex vivo measured in tissue homogenates under exposure of different substrates, stimulating different complexes of the electron transport chain of the mitochondria.
15978354|NCT03049228|Diagnostic Test|Blood analysis|To determine blood glucose metabolism and renal function.
15978355|NCT03049228|Diagnostic Test|Body composition|This device uses air displacement plethysmography for determining percent fat and fat-free mass in adults and children. The 5-minute test consists of measuring the subject's mass (weight) using a very accurate electronic scale, and volume, which is determined by sitting inside the BOD POD chamber. From these two measurements, the subject's body composition is calculated.
15978356|NCT03049228|Diagnostic Test|Indirect Calorimetry|As basal energy metabolism might be related to cardiac metabolism and mitochondrial function, and basal metabolic rate shows inter-individual variance, it is an important subject characteristic of the patients. Resting substrate oxidation rates are measured with indirect calorimetry for 30 minutes. A ventilated hood is connected to indirect calorimetry equipment, which measures concentrations of oxygen consumption and CO2 production. From these parameters, the respiratory quotient (RQ), as well as energy expenditure and substrate metabolism will be computed. During this measurement, every 10 minutes (so 4 times) one tube of blood (10ml) will be drawn for the analysis of lipid and glucose metabolites.
15978357|NCT03049215|Device|Lumen Apposing Metal Stent (LAMS)|The AXIOS Stent and Electrocautery-Enhanced Delivery System is an endoscopic device designed to enable the ultrasound trained interventional endoscopist to deliver a transenteric stent between the gastrointestinal tract and a pancreatic pseudocyst.
15978358|NCT03049215|Device|LAMS plus double pigtail stent|The AXIOS Stent and Electrocautery-Enhanced Delivery System is an endoscopic device designed to enable the ultrasound trained interventional endoscopist to deliver a transenteric stent between the gastrointestinal tract and a pancreatic pseudocyst. The double pigtail stent is a routinely used plastic biliary stent.
15978359|NCT03049189|Drug|177Lu-edotreotide PRRT|PRRT using 177Lu-edotreotide will be performed 3-monthly. A maximum of four cycles will be administered.
15978360|NCT03049189|Drug|Everolimus|Everolimus will be adminstered as a standard dosis of 10 mg daily which may be reduced where required for acceptable tolerability.
15978361|NCT03049189|Other|Amino-Acid Solution|The Amino-Acid Solution (AAS) to be used in this study will contain a mixture of 25 g lysine and 25 g arginine diluted in 2000 mL of electrolyte solution, infused over 4 - 6 h, starting 30 - 60 min before PRRT
15978362|NCT03049176|Drug|PrEP (Truvada)|oral, daily Truvada for HIV-negative participants
15978363|NCT03049176|Drug|Antiretrovirals|oral daily antiretrovirals and frequent viral load monitoring for HIV-positive participant
15978364|NCT03049176|Procedure|Semen washing|collection of semen from an HIV-positive man, processing semen to remove HIV, followed by intrauterine insemination
15978365|NCT03049176|Procedure|Artificial vaginal insemination|collection of semen from an HIV-negative man, followed by intravaginal insemination
15978366|NCT03049163|Drug|vitrectomy under topical anesthesia [Proparacaine HCL (Alcaine®)]|to observe the anesthesia effect of topical anesthesia of 27-gauge vitrectomy for vitreous floaters
15978367|NCT03049137|Procedure|Computer Guided Stent Augmentation|Defective alveolar ridge is to be replaced by simultaneous implant placement with ring graft augmentation (Trephine Drill to obtain the ring graft autogenous bone) using computer guided stent and covered with Platelet-rich fibrin (PRF), by using venous blood from the patient, a centrifuge will be used to obtain the top layer after centrifuging blood at 3000 Revolution Per Minute (RPM) for 10 minutes.
15978368|NCT03049137|Procedure|Free Hand Augmentation|Defective alveolar ridge is to be replaced by Free Hand simultaneous implant placement with ring graft augmentation (Trephine Drill to obtain the ring graft autogenous bone) and covered with Platelet-rich fibrin (PRF), by using venous blood from the patient, a centrifuge will be used to obtain the top layer after centrifuging blood at 3000 RPM for 10 minutes.
15978369|NCT03049137|Drug|Platelet-rich fibrin (PRF)|
15978370|NCT03049137|Device|implant|
15978371|NCT03049124|Behavioral|Exercise|Participants will engage in supervised exercise 3 times per week for 60-75 minutes/session for 12 weeks. Sessions will include a warm-up (aerobic activity less than < 60% of heart rate reserve), aerobic training (30 minutes of exercise at 60-75% of heart rate reserve, using cycle ergometers/treadmills), strength training (8 exercises; upper body, lower body, and core), and a cool-down (aerobic activity less than < 60% of heart rate reserve) component.
15978372|NCT03049111|Biological|Der f|Inhalation of Der f in mild asthmatics who are sensitive to Der f.
15978373|NCT03049098|Behavioral|Simulation|A 9-minute scenario based on an ACLS bradycardia algorithm in which a high-fidelity mannequin requires external pacing
15978374|NCT03049085|Drug|Aspirin|preoperative uncoated 75 mg Aspirin is administered 2 hours prior OPCAB
15978375|NCT03049085|Drug|vitamin C|preoperative 75 mg Vit. C (Placebo) is administered 2 hours prior OPCAB
15978376|NCT03049072|Radiation|Protons and Carbon Ions|
15978377|NCT03049059|Device|Fractional Picosecond 1,064 nm laser|Fractional Picosecond 1,064 nm laser and daily application with 4% hydroquinone cream
15978378|NCT03049059|Drug|4% hydroquinone cream|
15978379|NCT03049046|Drug|CC100|synthetic caffeic acid phenethylester
15978380|NCT03049046|Drug|Placebos|Diluent
15978381|NCT03049033|Other|Neurologic Music Therapy|Neurologic Music Therapy uses rhythms to change brain activity and function.
15978382|NCT03049033|Other|Occupational Therapy|Occupational Therapy uses traditional motor training.
15978383|NCT03049033|Other|Music Supported Therapy|Music Supported Therapy uses musical instruments to train fine motor movements.
15978384|NCT03049020|Procedure|laparoscopic sacrocolpopexy|standard laparoscopic sacrocolpopexy for prolapse treatment
15978386|NCT03048994|Dietary Supplement|Glutamine|"Patients randomised to receive glutamine supplementation will receive IV glutamine (0.5g/kg body weight/day) continuously over 24 hours.
~IV glutamine will be administered for 5 days or less if death ensues prior to 5 days or transferred to another hospital prior to 5 days. IV glutamine will be continued even if the patient is transferred outside the ICU but within the hospital.
~An intravenous saline solution that is identical in volume, color and consistency will be administered to the placebo group with the same dosing regimen and duration."
15978387|NCT03048994|Dietary Supplement|Placebo|"Nutritional support will be continued as per managing ICU team discretion.
~Management of severe sepsis will be continued as per managing ICU team discretion.
~Weaning patients from mechanical ventilation will be done as per managing ICU team discretion.
~To minimise differences between centers, active dissemination of practice guidelines for nutritional support, sepsis management and weaning will be carried out."
15978388|NCT03048981|Drug|Fish oil|Blood samples before and after 10 day intake of maximum dose fish oil
15978389|NCT03048968|Procedure|Gait, sit-to-stand movement, stair climbing and treadmill gait|Spatio temporal characteristics, muscle activation and foot pressure distribution are measured by motion capture system, surface electromyography (sEMG) and F-Scan Mobile system during 10m walking test. Muscle activation and foot pressure distribution are measured by surface electromyography (sEMG) and F-Scan Mobile system during five times sit-to-stand test.Muscle activation and foot pressure distribution are measured by surface electromyography (sEMG) and F-Scan Mobile system during stair climbing. Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.
15978390|NCT03048968|Procedure|Sit-to-stand movement and treadmill gait|Muscle activation and foot pressure distribution are measured by surface electromyography (sEMG) and F-Scan Mobile system during five times sit-to-stand test. Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.
15978391|NCT03048968|Device|gait enhancing mechatronic system (GEMS)|"Gait, sit-to-stand movement, stair climbing and treadmill gait with GEMS and without GEMS in elderly adults.
~Sit-to-stand movement and treadmill gait with GEMS and without GEMS in stroke patients."
15978392|NCT03048968|Device|treadmill|Cortical activation is measured by functional Near-Infrared-Spectroscopy (fNIRS) (NIRScout, NIRx, Germany) during treadmill gait.
15978393|NCT03048955|Device|Superion® IDS|Device is a non-fusion, spinal column load-sharing device used to stabilize the spine at the implanted leve
15978394|NCT03048955|Procedure|Direct decompression Surgery|A surgical procedure - the control
15978395|NCT03048942|Drug|Cabazitaxel|3 weekly cyctotoxic chemotherapy
15978396|NCT03048942|Drug|Paclitaxel|Weekly cyctotoxic chemotherapy
15978397|NCT03048929|Biological|Typhoid Vi Polysaccharide Vaccine|Salmonella typhi capsular polysaccharide vaccine (Typhoid Vi Polysaccharide Vaccine): Each dose of 0.5ml Salmonella typhi capsular polysaccharide vaccine (Sanofi Pasteur, SA) is formulated to contain 25μg of purified Vi polysaccharide in a colorless isotonic phosphate buffered saline (pH 7±0.3), 4.150mg of sodium chloride, 0.065mg of disodium phosphate, 0.023mg of monosodium phosphate and 0.5ml of sterile water for injection. It is indicated for use by humans aged 2 years and older for protection against typhoid fever.
15978398|NCT03048929|Biological|Placebo|The placebo injection will consist of 0.5mL of saline.
15978399|NCT03048916|Other|general swallowing therapy|including a session of oral exercises, tactile stimulation, compensatory techniques, swallowing maneuvers that are taught to the participants by a speech therapist.
15978400|NCT03048916|Other|NMES therapy|he NMES therapy with VitalStim therapeutic device will be done by one physician who is licensed practitioner and certified in use of the VitalStim device. The placement of 2-channel electrodes is depended on the dysphagic types and the findings on VFS.
15978401|NCT03048903|Drug|Rheum Palmatum Root|Rhubarb is commercially certified rhubarb(Rheum palmatum , Sichuan origin, provided by the pharmacy of my hospital), ground into a powder, over 80 mesh steel mesh.The dose is 6g in the first 2 days, 3 times / day, oral or nasal feeding,two days later the dose is reduced to 3g, three times / day, oral or nasal feeding.
15978402|NCT03048903|Drug|Starch Corn|Starch Corn is harmless to people .The use dosage is same as Rheum Palmaturn Root.The dose is 6g in the first 2 days, 3 times / day, oral or nasal feeding,two days later the dose is reduced to 3g, three times / day, oral or nasal feeding.
15978403|NCT03048890|Behavioral|Physical activity levels|Patients with severely low physical activity levels will be notified to consult their physician.
15978404|NCT03048877|Drug|Apatinib Oral Tablet|Apatinib Mesylate Tablets
15978405|NCT03048877|Drug|Placebo Oral Tablet|Placebo Oral Tablet
15978406|NCT03048851|Device|Low dosage SES group|The participants were randomly assigned to one of the five intervention groups. Low dosage SES group received the SES (Micro-Z Mini, Prizm Medical Inc., USA) training in addition to traditional rehabilitation. Each SES session involved electrical stimulation followed by UE training in addition to home program.The novel SES programs were conducted twice per week, for 12 weeks. Each SES session involved electrical stimulation followed by UE training in addition to home program. The SES was applied to the forearm and whole hand with mesh glove (Electro-Mesh Glove-Sleeve Electrode Kit) for 45 minutes and arm with wrap for 45 minutes. The pulse width was set to 300us for all stimulation levels. The frequency was set to 100 Hz and 10 Hz.
15978407|NCT03048851|Device|High dosage SES group|The participants were randomly assigned to one of the five intervention groups. High dosage SES group received the SES (Micro-Z Mini, Prizm Medical Inc., USA) training in addition to traditional rehabilitation. Each SES session involved electrical stimulation followed by UE training in addition to home program.The novel SES programs were conducted twice per week, for 12 weeks. Each SES session involved electrical stimulation followed by UE training in addition to home program. The SES was applied to the forearm and whole hand with mesh glove (Electro-Mesh Glove-Sleeve Electrode Kit) for 90 minutes and arm with wrap for 90 minutes. The pulse width was set to 300us for all stimulation levels. The frequency was set to 100 Hz and 10 Hz.
15978468|NCT03048370|Procedure|Left warm CVS|Caloric vestibular stimulation (CVS), which involves the irrigation of cold or warm water into the external ear canal, induces a temperature gradient across the semicircular canals of the vestibular apparatus stimulating the vestibular nerve. It is commonly used in both otolaryngology to assess vestibular function and neurology to test brain stem function
15978569|NCT03047590|Behavioral|Choice-based Exercise Intensity|Participants are instructed to choose whichever intensity they want, rather than regulate their intensity based on heart rate.
15978408|NCT03048851|Device|VRCIT group|The participants were randomly assigned to one of the five intervention groups. VRCIT group received the VRCIT training plus traditional rehabilitation, conducted twice per week for 12 weeks. Each VRCIT session involved practice of functional tasks with the more affected UE followed by virtual-reality based eye-hand coordination tasks with the more affected UE for, plus home program, and restraint of the less affected UE for 1.5 hours per day. The functional training of the more affected UE focused on massive practice of functional activities using the more affected arm, with the principles of shaping and repetitive task practice applied during training. The VRCIT combined CIT and commercially available VR-based systems including Sony Playstation EyeToy and Nintendo Wii.
15978409|NCT03048851|Device|VRCIT+SES group|The participants were randomly assigned to one of the five intervention groups. VRCIT+SES group executed VR programs by affected UE in Mesh-gloves (Electro-Mesh Glove-Sleeve Electrode Kit) with the optimal SES (Micro-Z Mini, Prizm Medical Inc., USA) protocol formulated from the 1st phase study. The VRCIT program was conducted 1.5 hours/time, twice/week for 12 weeks. The VRCIT combined CIT and commercially available VR-based systems. Some commercially programs, such as Sony Playstation EyeToy (Sony Computer Entertainment America, Foster City, Calif., USA), and Nintendo Wii (Nintendo Domestic Distributor, College Point, N.Y., USA).
15978410|NCT03048851|Procedure|traditional rehabilitation program|The participants were randomly assigned to one of the five intervention groups. The absence of muscle contractions was controlled by the investigator the sham stimulation was carried out identically, but the stimulation amplitude was set to 0 milliampere(mA). Subjects were not informed about the stimulation level and were instructed to distract attention from the stimulation.
15978411|NCT03048838|Behavioral|Risk reduction behavioral intervention|
15978412|NCT03048838|Behavioral|Wellness Promotion Intervention|
15978413|NCT03048825|Drug|Colchicine|Colchicine 0.5 mg twice daily
15978414|NCT03048825|Drug|Spironolactone|Spironolactone 25 mg once daily
15978415|NCT03048825|Device|SYNERGY Bioabsorbable Polymer Drug-Eluting Stent|Trial participants who receive a SYNERGY™ Bioabsorbable Polymer Drug-Eluting (everolimus) Stent during their index PCI for STEMI will be included in the SYNERGY Stent Registry.
15978416|NCT03048825|Drug|Colchicine-Placebo|Matching Colchicine-placebo twice daily
15978417|NCT03048825|Drug|Spironolactone-Placebo|Matching Spironolactone-Placebo once daily
15978418|NCT03048812|Device|O'Ring Attachment (A)|Attachment A will be inserted in three months of follow up,followed by treatment B in a random order
15978419|NCT03048812|Device|Equator Attachment (B)|Attachment B will be inserted in three months of follow up,followed by treatment A in a random order
15978420|NCT03048799|Device|Radiofrequency|The radiofrequency application protocol will be used in the form of capacitive electrical transfer, bipolar configuration, with CAPENERGY device (Figure 1), which has two electrodes: an active one, which will be introduced into the anal region, using a condom and gel to The emission of radiofrequency and another electrode, dispersive, coupled to the patient's hip, which will function as earth. The active electrode has at its end a sensor capable of capturing the temperature. The temperature used in the treatment will be 41 ° C, which this parameter will be placed in the equipment. Upon reaching the desired heating, the apparatus maintains the temperature and thus the application of the radiofrequency will be maintained for 2 minutes.
15978421|NCT03048786|Behavioral|Control|Participants will receive automated text messages used by SmokefreeTXT. The messages are designed to provide encouragement, support, and information about quitting smoking. Participants will receive 1-5 automated messages per day for 6-8 weeks depending on choice of quit date.
15978422|NCT03048786|Behavioral|Peer Mentoring|"Participants will receive a modified version of the automated text messages sent to the control arm plus random assignment to a peer mentor. The modified messages include automated conversation starters, designed to stimulate conversation with the peer mentor. The peer mentor will then send personalized, tailored responses. The peer mentor is a former smoker who has completed a training program developed by the investigator team. Participants will receive 1-5 automated messages per day for 6-8 weeks depending on choice of quit date."
15978423|NCT03048773|Device|shockwave therapy|Intervention with shockwave therapy
15978424|NCT03048773|Other|PT|Physical therapy 3 times per week for 3 weeks
15978425|NCT03048773|Other|placebo|sham shockwave therapy
15978426|NCT03048760|Other|MRI scan|All participants will undergo 2 MRI scans - 1 at the time of their radiotherapy planning scans & 1 after approx. 2 weeks of radiotherapy treatment.
15978427|NCT03048747|Drug|Tolvaptan Oral Tablet|Tolvaptan tablets at 7.5, 15, 30 (one tablet each), or 60 mg (two 30 mg tablets) will be orally administered once daily after breakfast for up to 30 days.
15978428|NCT03048721|Procedure|Skin Tape Stripping|For psoriasis group, tape-stripping will be done in both involved and uninvolved skin. The tape-stripping will be performed within 2.5 cm of the first punch biopsy. For healthy control group, tape-stripping will be performed on normal skin, within 2.5. cm of the first punch biopsy.
15978429|NCT03048721|Procedure|Punch Biopsy|For psoriasis group, one punch biopsy will be taken from each of the following areas: involved skin, tape-stripped involved skin, uninvolved skin, and tape-stripped uninvolved skin. For healthy control group, one punch biopsy will be taken from each of the following areas: normal skin and tape-stripped normal skin (within 2.5 cm of the first punch biopsy).
15978430|NCT03048708|Procedure|Bariatric surgery|patients who had received treatment with bariatric surgery for medical reasons
15978431|NCT03048695|Behavioral|GMT|Metacognitive strategy training where the primary objective is to stop ongoing behavior to define goal hierarchies and monitor performance
15978432|NCT03048682|Device|Foley catheter - Early Voiding Trial|"All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial.
~Subjects in the Early Voiding group will have their repeat voiding trial on post-op day #2, 3, or 4 will undergo an in-office voiding trial. The experimental group will return for an in-office voiding trial sooner than the active comparator."
15978433|NCT03048682|Device|Foley catheter - Late Voiding Trial|"All subjects that are discharged home with a Foley catheter will need an in-office repeat voiding trial.
~Subjects in the Late Voiding group will have their repeat voiding trial on post-op day #7 or after. This is our current practice"
15978501|NCT03048110|Drug|BAY1841788 (ODM-201)|In Period 1, 600 mg single dose administered as 2x300 mg tablets on Study Day 1, In Period 2, 600 mg single dose administered as 2x300 mg tablets on Study Day 5, In Period 3, 600 mg single dose administered as 2x300 mg tablets at Study Day 8.
15978434|NCT03048669|Other|Continuous quality improvement|A quality improvement team at the health district and at the clinics levels. A clinic level QI team will include at least one staff each from antenatal care (ANC), delivery/maternity, and well-child services. The head of the each QI team plus a supervisor from the health district bureau and a study team member constitute the district QI team. Immediately following randomization, we will bring together QI teams to review program and quality indicators from their clinics and across districts to identify key bottlenecks in the care delivery system and agree on an action plan to modify them. QI teams will be responsible for the implementation of the action plan at the level of their respective clinics. Every three months, using data from the monitoring system, the process will be repeated for a duration 18 months. To limit possible contamination, all staff from a randomized district/clinic who may have a dual appointment in another facility will be excluded from QI teams.
15978435|NCT03048656|Other|static posturography|The measurement of the weight distribution and the static posturography was performed on the balance platform Good Balance by Metitur . The device is comprised of the triangular force platform with electronic system and computer software. The body weight distribution was evaluated in the upright standing with eyes open, feet placed 20 cm from each other.The individual stood motionlessly for 15 s, then the measurement was recorded. The static posturography was performed with 3 various positions of feet, both with eyes open and eyes closed. (1) Position : normal standing - an upright standing with feet placed parallel 20 cm apart for 30 s. (2) Position: tandem - a stance with one foot placed ahead of the other. for 20 s. (3) Position: one leg standing: stance on the one leg for 20 s.
15978436|NCT03048643|Behavioral|Outpatient parenteral antibiotic therapy|Subjects randomized to OPAT will complete IV antibiotic therapy for infective endocarditis as an outpatient according to published guidelines.
15978437|NCT03048630|Behavioral|Education|Owner-to-Worker training about reducing chemical exposures in nail salons
15978438|NCT03048604|Device|Genio(TM) bilateral hypoglossal nerve stimulation system|Subjects will be consented, enrolled and eligibility criteria checked. If the subject is eligible, subject will proceed with the Genio(TM) implant implantation. Four (4) weeks after implantation, the implant will be activated and the subject will be assessed at 1 month plus 1 week, 2, 3, 4 and 6 month(s) after implantation.
15978439|NCT03048591|Device|electroacupuncture|Acupoint selection: Bilateral Hegu (LI4), Qu-chi (LI1) of upper limbs and bilateral Zusanli (ST36) ,Taichung (LR3)of lower limbs.
15978440|NCT03048578|Drug|Saxenda|Week 1: 0.6mg/day Week 2: 1.2mg/day Week 3: 1.8mg/day Week 4: 2.4mg/day Week 5 and Onward: 3.0mg/day
15978441|NCT03048578|Drug|Placebo|Subcutaneous Saline Solution
15978442|NCT03048565|Behavioral|MBSR|Mindfulness is a skill that helps people manage their thoughts so that the stressful impact of unhelpful thoughts can be limited. The aim of the mindfulness based intervention in this study is to help caregivers manage stressful thoughts and events and help them respond to life stressors in a positive way.
15978443|NCT03048552|Behavioral|Family CONNECT|Linkage specialists, who are clinical social workers and embedded within the probation departments, will work with specifically caregiver-youth dyads in the Family CONNECT arm to link youth to substance use services.
15978444|NCT03048539|Procedure|Transoral endoscopic thyroidectomy|This procedure will remove thyroid lobe through oral vestibule. Aim to avoid scar at anterior neck.
15978445|NCT03048526|Device|NovaTears®|Topical eye drops for lubrication of the ocular surface
15978446|NCT03048526|Device|Hydrabak®|Eye drops
15978447|NCT03048513|Other|Patient who presented with melioidosis in head and neck|Investigators assess the patients who had the pus culture positive with Burkholderia pseudomallei.
15978448|NCT03048500|Other|Laboratory Biomarker Analysis|Correlative studies
15978449|NCT03048500|Drug|Metformin Hydrochloride|Given PO
15978450|NCT03048500|Biological|Nivolumab|Given IV
15978451|NCT03048474|Drug|nivolumab and ipilimumab|
15978452|NCT03048461|Device|Platelet Rich Plasma Prep System|intradermal injections of platelet rich plasma to an area of alopecia
15978453|NCT03048461|Drug|Placebo|intradermal injections to an area of alopecia
15978454|NCT03048448|Drug|Fevipiprant|Single 450mg dose
15978455|NCT03048435|Other|EORTC QLQ CX-24|Disease specific Patient Reported Outcome measurement tool developed by the European Organization for Research and Treatment of Cancer (EORTC). This questionnaire covers symptoms common to women with cervical cancer and captures the impact of disease and/or treatment on domains including: urologic and gastro-intestinal symptoms, sexual functioning and body image.
15978456|NCT03048435|Other|Physician Feedback Form|This Feedback form to be completed by oncologists who have had at least one consenting patient participating in this study.
15978457|NCT03048422|Drug|Dolutegravir|One 50 mg DTG tablet will be administered orally once daily
15978458|NCT03048422|Drug|Emtricitabine/tenofovir alafenamide|One fixed-dose combination tablet (FTC 200 mg/TAF 25 mg) will be administered orally once daily
15978459|NCT03048422|Drug|Emtricitabine/tenofovir disoproxil fumarate|One fixed-dose combination tablet (FTC 200 mg/TDF 300 mg) will be administered orally once daily
15978460|NCT03048422|Drug|Efavirenz/emtricitabine/tenofovir disoproxil fumarate|One fixed-dose combination tablet (EFV 600 mg/FTC 200 mg/TDF 300 mg) will be administered orally once daily
15978461|NCT03048409|Other|Enteral Formula|Enteral feeding with a peptide-based formula.
15978462|NCT03048396|Procedure|Uterus transplantation|
15978463|NCT03048383|Drug|OnabotulinumtoxinA Injectable Product|Administered to treat facial synkinesis
15978464|NCT03048383|Drug|AbobotulinumtoxinA Injectable Product|Administered to treat facial synkinesis
15978465|NCT03048383|Drug|Incobotulinumtoxin A Injectable Product|Administered to treat facial synkinesis
15978466|NCT03048370|Procedure|Left body temperature VS|Caloric vestibular stimulation (CVS), which involves the irrigation of cold or warm water into the external ear canal, induces a temperature gradient across the semicircular canals of the vestibular apparatus stimulating the vestibular nerve. It is commonly used in both otolaryngology to assess vestibular function and neurology to test brain stem function
15978467|NCT03048370|Procedure|Right body temperature VS|Caloric vestibular stimulation (CVS), which involves the irrigation of cold or warm water into the external ear canal, induces a temperature gradient across the semicircular canals of the vestibular apparatus stimulating the vestibular nerve. It is commonly used in both otolaryngology to assess vestibular function and neurology to test brain stem function
15978470|NCT03048370|Procedure|Left cold CVS|Caloric vestibular stimulation (CVS), which involves the irrigation of cold or warm water into the external ear canal, induces a temperature gradient across the semicircular canals of the vestibular apparatus stimulating the vestibular nerve. It is commonly used in both otolaryngology to assess vestibular function and neurology to test brain stem function
15978471|NCT03048370|Procedure|Right cold CVS|Caloric vestibular stimulation (CVS), which involves the irrigation of cold or warm water into the external ear canal, induces a temperature gradient across the semicircular canals of the vestibular apparatus stimulating the vestibular nerve. It is commonly used in both otolaryngology to assess vestibular function and neurology to test brain stem function
15978472|NCT03048357|Device|Freedom Bed|Fully Integrated Lateral Rotation Bed System that automatically turns the patient to a specific angle in degrees between from 15-25 with dwell times between 1-120 minutes.
15978473|NCT03048357|Other|Standard hospital bed|Caregiver turning patients to one side then the other every 2 hours for pressure relief over bony prominence's.
15978474|NCT03048344|Drug|ORH-2014|ORH-2014 capsule 5 mg orally with dose escalations of 5 mg intervals.
15978475|NCT03048344|Drug|ORH-2014|ORH-2014 capsule at recommended dose orally.
15978476|NCT03048331|Device|Functional Electrical Stimulation|"Functional electrical stimulation is applied with stimulators according to the lesion. In case of a upper motor neuron lesion the stimulation operates via nerve. For the stimulation surface electrodes are placed on the skin over the muscle belly. The stimulation of the innervated muscles will be conducted using the following conditions:
~300-400 usec, 20-50 Hz, amplitude depends on the quality of muscle contraction (20-80 mA). the duty cycle of the stimulation is 3 sec. ramp up, 5 ec. plateau, 2 sec. ramp down, 10 sec. pause."
15978477|NCT03048318|Procedure|Arterial Flushing|
15978478|NCT03048318|Procedure|Portal Flushing|
15978479|NCT03048292|Other|Acute Endovascular Stroke Treatment|
15978480|NCT03048279|Behavioral|Questionnaires|"Multiple Endocrine Neoplasia Syndromes: MEN1/MEN2 Group: Participants interviewed by phone and/or mail to obtain medical history specific to their diagnosis of either MEN1 or MEN2.
~Close Relatives of Registered MDACC MEN Patients Group: Participants asked to complete a health and family history questionnaire. This questionnaire process may be completed by phone or mail."
15978481|NCT03048253|Biological|OrienX010|Beijing biological technology co., LTD. Research and development of the source and force of recombinant human GM-CSF herpes simplex virus injection (OrienX010), is a genetically engineered type 1 herpes simplex virus (HSV - 1) as the carrier insert GM-CSF gene therapy drug.Its carrier is made of isolated from patients with oral Chinese wild single blister virus type I (CL1), after gene recombination technology successively removing ICP34.5, ICP47 and insert the deactivation ICP6 gene, and at the site of the original ICP34.5 insert guided by IE promoter of hCMV human GM-CSF gene.
15978482|NCT03048240|Device|"perPDT"|"The protocol requires the realization of specific procedures in addition to the usual care.
~The per-operative photodynamic therapy (perPDT) added to surgery for glioblastoma excision. The patient will receive 5-ALA (5- alanine ,GLIOLAN drinkable) 4h before surgery + lighting of the tumor bed by a light source (laser) at the end of resection (Prolonged surgery of 45 minutes)."
15978483|NCT03048240|Drug|GLIOLAN|patient will receive 5-ALA (5- alanine ,GLIOLAN drinkable) 4h before surgery
15978484|NCT03048227|Device|Continuous Glucose Measurement (CGM)|Patients will manage their diabetes with the help of Continuous Glucose Measurements (Abbott Freestyle Navigator II).
15978485|NCT03048214|Procedure|Infraclavicular nerve block|Infraclavicular nerve block is a relatively safe and straightforward brachial plexus nerve block that can be used to provide intraoperative regional anaesthesia for upper limb surgeries from the elbow to fingers.
15978486|NCT03048214|Procedure|General anaesthesia|Usual practice for upper limb surgeries.
15978487|NCT03048201|Device|Physica Kinematic Retaining Knee System|Modular total knee prosthesis with a Kinematic Retaining mechanism and posterior cruciate ligament (PCL) preservation
15978488|NCT03048201|Device|Physica Cruciate Retaining Knee System|Total knee prosthesis with posterior cruciate ligament (PCL) preservation
15978489|NCT03048201|Device|Physica Posterior Stabilized Knee System|Total knee prosthesis that sacrifices the posterior cruciate ligament (PCL) and replaces the functionality of the PCL with a post-cam mechanism.
15978490|NCT03048188|Other|wound dressing|Manuka honey wound dressing
15978491|NCT03048175|Procedure|Wisdom tooth removal|After inferior dental and buccal nerve anesthesia a triangular full thickness flap with releasing incision on the mesio-buccal aspect of the second molar is designed. Ostectomy is then performed and tooth is sectioned and gently elevated. Once all the tooth components are extracted, the socket is carefully inspected and flap is sutured with interrupted sutures.
15978492|NCT03048162|Drug|sodium chloride|500 ml of 0.9% isotonic sodium chloride
15978493|NCT03048162|Drug|Hydroxyethylstarch|500 ml of 6% Hydroxyethylstarch
15978494|NCT03048162|Drug|Ringer-Lactate Infusion Solution Bag|500 ml of Ringer-Lactate Infusion Solution Bag
15978495|NCT03048136|Drug|Nivolumab|Specified dose on specified days
15978496|NCT03048136|Drug|Ipilimumab|Specified dose on specified days
15978497|NCT03048123|Procedure|Hepatic arterial infusion|A standard hepatic artery catheter was introduced via the femoral artery percutaneously. Selective catheterization of the proper hepatic artery was performed using standard diagnostic catheters and fluoroscopic guidance. In the event of multiple arterial supply(including superior-mesenteric artery), the proportion of the liver supplied by each artery was estimated by the arteriogram. After optimal positioning of the catheter in dominant supplying artery to ensure minimal reflux, the catheter was fixed and connected with infusion tube. In the condition of multiple tumors on both left and right lobe, the gastroduodenal artery was embolized and the catheter was positioned in the hepatic proper artery for infusion. Folfox Protocol were infused through the fixed catheter sequentially
15978498|NCT03048123|Procedure|Transarterial chemoembolization|Previous procedure was same with hepatic arterial infusion chemotherapy. After optimal positioning of the catheter, TACE Drug Protocol were injected.
15978499|NCT03048123|Drug|Folfox Protocol|oxaliplatin,leucovorin and 5-FU
15978500|NCT03048123|Drug|TACE Drug Protocol|lipiodol mixed with chemotherapy drugs(EADM , lobaplatin, and MMC) followed by polyvinyl alcohol particles (PVA)
15978502|NCT03048110|Drug|Itraconazole|200 mg twice daily (BID) administered as 2 x 100 mg capsules per dose in treatment period 2 on Study Day 1, 200 mg once daily (QD) administered as 2 x 100 mg capsules per dose in treatment period 2 on Study Days 2 to 7.
15978506|NCT03048097|Diagnostic Test|FDG-PET/CT with Rb82 Myocardial Perfusion Imaging|A 18-20 gauge catheter equipped with a 3-way stopcock will be inserted preferably in the antecubital vein. Cardiac FDG-PET imaging will be performed on the YNHH GE Discovery ST PET/CT scanner following a high fat/low carbohydrate diet and a prolonged fast as is current clinical protocol. Resting ECG-gated dynamic Rb-82 PET imaging will be performed using 20-30 mCi of Rb82 as per YNHH clinical imaging protocol and established clinical guidelines. FDG-PET imaging will be performed following a high fat/low carbohydrate diet (instructions provided to patient) and a fast of greater than 12 hours. The patient will be injected with the same dose of FDG (8-10mCi) as they received for their index clinical examination. Cardiac FDG imaging will be performed using a single 3D acquisition over the heart. Low-dose CT images (120 kV, 50-150 mA based on BMI) for the purposes of attenuation correction will be performed before Rb82 and FDG imaging sequences.
15978507|NCT03048084|Drug|Levetiracetam|Antiepileptic drug levetiracetam
15978508|NCT03048084|Drug|Valproic Acid|Antiepileptic drug valproic acid
15978509|NCT03048071|Other|Data collection within medical files|Data collection within medical files
15978510|NCT03048058|Drug|brimonidine topical gel 0.33% & survey|The internet survey will ask them how often they have used their medication that week, as well as giving them treatment tips and reminders about rosacea triggers. They will be asked a variety of questions during the weekly internet survey- such as the amount of erythema they currently have (measured by VAS scale), how much burning and stinging they have, how often they have used the medication and where did they apply the medication, as well as any additional side effects they may be having from the medication.
15978511|NCT03048058|Drug|brimonidine topical gel 0.33% & SOC|All subjects will receive standard-of-care brimonidine topical gel 0.33%
15978512|NCT03048045|Procedure|Supportive Periodontal Treatment (SPT)|Assessment of Gingival Bleeding Index and Plaque Control Record, re-instruction and re-motivation to effective individual plaque control, professional tooth cleaning, application of a fluoride gel. Twice a year a periodontal charting with probing pocket depths (PPD) and vertical attachment Level (PAL-V) are obtained at 6 sites per tooth. Thirty seconds after probing bleeding on probing (BOP) is recorded. Sites exhibiting PPD = 4 mm and BOP as well as sites with PPD >/= 5 mm are scaled subgingivally. Assignment of SPT intervals is performed according to the periodontal risk assessment (PRA).
15978513|NCT03048032|Procedure|Blood sampling|Besides routine clinical, laboratory and instrumental evaluation, blood samples will be taken within 4 hours of presentation to the hospital. Plasma samples, stored and frozen at -80°C, will be analyzed at the INSERM UMR942 institute in Paris. Up to 15 novel will be measured during the study: copeptine, proenkephalin, high sensitivity troponin T, troponin I, brain natriuretic peptide (BNP), N-terminal pro-BNP, adrenomedullin, soluble ST2, galectine 3, C-reactive protein, interleukine 6, procalcitonin, cystatin C, neutrophil gelatinase associated lipocalin.
15978514|NCT03048032|Procedure|Echocardiography exam|A standard echocardiography as well as examination focused on right ventricle (RV) will be performed in a period of 48 hours of admission. Novel qualitative and quantitative parameters of right ventricle function and structure will be measured. These include RV diameter at base and midlevel, a measure of RV fractional area change (FAC), tissue doppler imaging derived tricuspid lateral annular systolic velocity wave (S'), tricuspid annular plane systolic excursion (TAPSE), velocity and gradient of tricuspid regurgitation, estimated systolic RV and RA pressure, RV wall strain and strain rate.
15978515|NCT03048019|Drug|Tirofiban|Patients will receive Tirofiban during the PCI procedure
15978516|NCT03048019|Drug|Cangrelor|Patients will receive Cangrelor during the PCI procedure
15978517|NCT03048006|Procedure|MRI with Dotarem|
15978518|NCT03047993|Drug|Azacitidine|Given IV or SC
15978519|NCT03047993|Drug|Glutaminase Inhibitor CB-839|Given PO
15978520|NCT03047980|Drug|Sirolimus|Low dose oral sirolimus
15978521|NCT03047967|Diagnostic Test|lung function tests|baby-body plethysmography
15978522|NCT03047967|Diagnostic Test|Nasal brushing|Epithelial sample collecting for in vitro study
15978523|NCT03047954|Drug|Broncho-Vaxom|BV is an orally administered immunostimulating preparation, which consists of a lyophilised bacterial extract prepared from 8 bacterial species (Haemophilus influenzae, Streptococcus pneumoniae, Klebsiella pneumoniae and ozaenae, Staphylococcus aureus, Streptococcus pyogenes and viridans, Neisseria catarrhalis)
15978524|NCT03047954|Drug|Placebo - Cap|Matching Placebo capsule administered
15978525|NCT03047941|Diagnostic Test|Determination of optimal cutoff values.|The results of the four scores will be compared with the results of the polysomnography (PSG). A statistical analysis will be performed to determine the optimal cutoff value of each of the four scores to detect severe OSA patient with hypoxemia.
15978526|NCT03047928|Drug|Nivolumab|Nivolumab 3 mg/kg is administered biweekly as long as there is clinical benefit.
15978527|NCT03047928|Biological|PD-L1/IDO peptide vaccine|The vaccine is administered biweekly for a total of 6 times, then every fourth week up to 47 weeks, whereupon no additional vaccinations will be given. A total of 15 vaccines will be administered. A vaccine consists of 100 μg PD-L1 long1 peptide, 100 μg IDO long peptide and 500 μl Montande as adjuvant.
15978528|NCT03047915|Other|Music|The intervention consists of listening to a choice of music for 30 to 60 minutes on a loaned iPad with disposable headphones.
15978529|NCT03047902|Other|Group 1 - Parents will be present for the Questionnaire.|"In Group 1 the parents will be present for the questionnaire. The information on the questionnaire will be disclosed to them.
~In Group 2 the parents will not be present for the questionnaire and the information will not be disclosed to them."
15978530|NCT03047902|Other|Group 2- Parents will not be present for the Questionnaire|
15978531|NCT03047889|Drug|standard therapy|standard therapy for advanced/metastatic breast cancer
15978532|NCT03047876|Procedure|aortic arch surgery|Children, from neonatal age to late infancy, undergoing aortic arch surgery (n=20) will have cerebral perfusion measurements during surgery, including during the cooling and rewarming phase, whilst on cardiopulmonary bypass and during the recovery period in the intensive care unit
15978533|NCT03047863|Drug|Repair Control EGF®|"A Split face study was done. Patients applied 1 finger tip unit of EGF cream on one side of face, twice a day for 4 weeks.
~EGF cream(Repair Control EGF®) containing 10 ppm of rhEGF was prepared at D.N. Co., Ltd. (Seoul, South Korea)"
15978570|NCT03047590|Behavioral|Positive Affect Focus|Participants are instructed to focus on feeling good while exercising.
15978780|NCT03045770|Drug|calcium levofolinate|Calcium levofolinate was used as first line treatment with AGC.
15978534|NCT03047863|Drug|Cream without rhEGF|"A Split face study was done. Patients applied 1 finger tip unit of cream on the other side of face, twice a day for 4 weeks.
~Placebo cream was prepared at at D.N. Co., Ltd. (Seoul, South Korea), consisted of same ingredient with EGF cream except rhEGF"
15978535|NCT03047850|Diagnostic Test|Comparison of Delta Down and Delta Pulse Pressure|Comparison of Delta Down and Delta Pulse Pressure Before and After Sternotomy.
15978536|NCT03047837|Drug|Aspirin (ASA) + Metformin (MET)|Arm D (experimental arm) Treatment: active ASA + active MET Dose: 100 mg, 1 tablet daily + 850 mg,1 tablet twice a day (BID) Duration: 12 months
15978537|NCT03047837|Drug|ASA|Arm C (experimental arm) Treatment: active ASA + placebo MET Dose: 100 mg, 1 tablet daily + 1 tablet twice a day (BID) Duration: 12 months
15978538|NCT03047837|Drug|MET|Arm B (experimental arm) Treatment: placebo ASA + active MET Dose: 1 tablet daily+ 850 mg, 1 tablet twice a day (BID) Duration: 12 months
15978539|NCT03047837|Drug|Placebos|Arm A (control arm) Treatment: placebo ASA + placebo MET Doses: 1 tablet daily +1 tablet twice a day (BID) Duration: 12 months
15978540|NCT03047824|Device|Intravascular continuous monitoring|Bedside usual insulin therapy guided by continuous glucose monitoring
15978541|NCT03047824|Other|Standard of care|Bedside usual insulin therapy guided by intemittent glucose monitoring
15978542|NCT03047811|Other|TCR - T cell therapy|Low dose group: 1 x 10 ^8 /kg T cell total reinfusion. High dose groups: 10 x 10 ^ 8 / kgT cell total reinfusion.
15978543|NCT03047798|Drug|Mouthrinse|"A randomized clinical intervention study was planned with a cross-over design. The 34 subjects were randomly allocated to one of the three experimental groups: 1) the control; 2) ASM group for aqueous single-phase mouthrinse; 3) OTM group for oil-water two-phase mouthrinse.
~Subjects were instructed to use the prescribed mouthrinse to gargle their mouth for one minute, twice daily for two weeks. The completion of each experiment regimen was followed by a 2-week washout period, after which the subjects of each group were permutated to the next mouthrinse trial until all three groups underwent the three mouthrinse trial regimen."
15978544|NCT03047772|Drug|Atorvastatin|Routine dose of Atorvastatin therapy
15978545|NCT03047772|Drug|Intensive Atorvastatin|Intensive dose of Atorvastatin therapy
15978546|NCT03047772|Drug|Low dose BMMSC|Low dose autologous Bone Marrow Mesenchymal Stem Cells transplantation
15978547|NCT03047772|Drug|Middle dose BMMSC|Middle dose autologous Bone Marrow Mesenchymal Stem Cells transplantation
15978548|NCT03047772|Drug|High dose BMMSC|High dose autologous Bone Marrow Mesenchymal Stem Cells transplantation
15978549|NCT03047772|Drug|Transplantation|Optimal dose autologous Bone Marrow Mesenchymal Stem Cells transplantation
15978550|NCT03047759|Device|water flosser|Powered
15978551|NCT03047759|Device|air floss|Powered
15978552|NCT03047746|Device|CliniMACs|Peripheral blood stem cells from closely matched unrelated or partially matched related donors will be processed using the CliniMACS device to remove TCRalpha/beta T cells and B cells, in accordance with the Investigator Brochure and Technical Manual following the laboratory standard operating procedures (SOPs) and using aseptic technique
15978553|NCT03047733|Device|The XTRAC Excimer Laser System|Initial irradiation dose was 50 mJ/cm2 on face and 100 mJ/cm2 on trunk and extremities. If there had not been minimal asymptomatic erythema, energy level was escalated by 50 mJ/cm2.
15978554|NCT03047733|Drug|Topical tacrolimus 0.1% ointment|Application of topical tacrolimus 0.1% ointment on the both lesions once daily.
15978555|NCT03047720|Device|Lully Sleep Guardian|"In the initial phase, participant baseline is established. In the Therapeutic Phase, each participant will complete the study phases (S1 and S2) in the order determined by their assigned treatment arm. During the scheduled awakening protocol using Lully Sleep Guardian, a scheduled awakening will be performed each night with the Lully pod.
~During the initial and therapeutic phases of this study, participants are asked to enter responses daily into a Lully Study app. The app will send a prompt each morning. The questions the participant is prompted to answer serve to document occurrence of bedwetting and the degree of wetness.
~In addition, the family will complete the KIDSCREEN 27 and the Vancouver questionnaire at defined intervals throughout the study."
15978556|NCT03047720|Device|Lully Sleep Guardian|"In the initial phase, participant baseline is established. In the Therapeutic Phase, each participant will complete the study phases (S1 and S2) in the order determined by their assigned treatment arm. During the scheduled awakening protocol using Lully Sleep Guardian, a scheduled awakening will be performed each night with the Lully pod.
~During the initial and therapeutic phases of this study, participants are asked to enter responses daily into a Lully Study app. The app will send a prompt each morning. The questions the participant is prompted to answer serve to document occurrence of bedwetting and the degree of wetness.
~In addition, the family will complete the KIDSCREEN 27 and the Vancouver questionnaire at defined intervals throughout the study."
15978557|NCT03047707|Diagnostic Test|S-Shearwave and TE|S-Shearwave elastography and Transient elastography (TE) are performed to evaluate hepatic stiffness.
15978558|NCT03047694|Other|tablet therapy|stimulation of the lexico semantic system on a tactile tablet therapy for 3 months
15978559|NCT03047694|Other|usual care|speech therapy
15978560|NCT03047681|Diagnostic Test|venous blood withdrawl|patients will be asked for a venous blood sample
15978561|NCT03047668|Dietary Supplement|diet with/without supplementation|diet with/without supplementation with PUFAs
15978562|NCT03047655|Behavioral|Lifestyle intervention (physical activity)|Dietary treatment with or without additional motivation on more physical activity
15978563|NCT03047655|Dietary Supplement|Lifestyle intervention (PUFA/isomaltulose-enriched muffin)|
15978564|NCT03047642|Diagnostic Test|Biomarker assay|There is no intervention on the patients but biomarker assays are being evaluated for their performance to distinguish bacterial infection from non-bacterial infections in febrile patients
15978565|NCT03047629|Drug|ENT-01|Daily dosing with ENT-01. ENT-01 is an orally administered proprietary substance formulated as a small 25mg coated tablet. Dosing will range from 25-200mg, and the dose will be taken upon awakening on an empty stomach with 8oz water simultaneous to dopamine.
15978566|NCT03047629|Other|Placebo|Daily dosing with a placebo
15978567|NCT03047616|Other|Blood and Urine Collection|
15978568|NCT03047603|Diagnostic Test|PIVKA-II|Serum samples are tested for tumor markers including PIVKA-II,AFP,AFP-L3% and biochemical tests.
15978571|NCT03047590|Behavioral|Heart rate-based Exercise Intensity|Participants are instructed to regulate their exercise intensity based on their heart rate.
15978572|NCT03047577|Behavioral|Brief intervention|A 15-20minute discussion about the patients alcohol use and its association with current health conditions, option for a discussion with social worker and written material (information about how alcohol affects health and contact details for seeking more support)
15978573|NCT03047564|Device|Coated Total Knee Arthroplasty|Implantation of a coated Total Knee Arthroplasty
15978574|NCT03047564|Device|Standard Total Knee Arthroplasty|Implantation of a Standard Total Knee Arthroplasty
15978575|NCT03047551|Procedure|Transabdominal sonography|Ultrasound machines vary by site. At Planned Parenthood and Columbia University Medical Center, providers utilize the LOGIQ P5 ultrasound machine, manufactured by General Electric Healthcare.
15978576|NCT03047551|Procedure|Transvaginal sonography|Ultrasound machines vary by site. At Planned Parenthood and Columbia University Medical Center, providers utilize the LOGIQ P5 ultrasound machine, manufactured by General Electric Healthcare.
15978577|NCT03047538|Drug|Atorvastatin, Amlodipine, Perindopril|To compare free and fixed combination of atorvastatin, perindopril, amlodipine
15978578|NCT03047525|Biological|Cytokine-induced Killer Cells|Concurrent of chemotherapy plus 4 cycles of Dendritic and Cytokine-induced Killer Cells(DC-CIK) treatment and 4 cycles of Cytokine-induced Killer Cells(CIK) treatment
15978579|NCT03047512|Behavioral|Experimental: Internet-based program|"Adolescents who obtain a score between 2 and 4 on the PHQ-3 will be invited to use the information module, the psychoeducational material and the symptom monitoring with personalized automatic feedback.
~Adolescents who obtain a score between 5 and 6 on the PHQ-3 will be invited to use, in addition to the above, group forum activities (peer support moderated by mental health professionals) and the possibility of a chat (individualized support by mental health professionals).
~Adolescents who obtain a score greater than 6 on the PHQ-3 or that have suicidal thoughts will be invited to see the mental health counselor of the institution and the possibility of their reference to face-to-face professional attention will be considered."
15978580|NCT03047499|Drug|Botulinum toxin type A|Botulinum toxin type-A injection
15978581|NCT03047473|Biological|avelumab|add on of avelumab 10mg/kg IV to standard therapy
15978582|NCT03047460|Other|multimodal evoked potentials|
15978583|NCT03047447|Behavioral|Dietary Ketosis: Regulator of Obesity and Metabolic Syndrome|30 adults previously diagnosed with MetS randomly prescribed to one of three groups: a sustained ketogenic diet with no exercise, the participant's normal diet with no exercise, or participant's normal diet with 3-5 days per week of exercise for 30 minutes
15978584|NCT03047421|Diagnostic Test|Comparison of accuracy of DES-OSA and P-SAP scores|Comparison of accuracy of DES-OSA and P-SAP scores with the result of the PSG (polysomnography)
15978585|NCT03047408|Procedure|Video polysomnography|the main objective of our study is to longitudinally evaluate clinical and vPSG features of RBD, including measure of RSWA, in patients with PD-RBD, after three years from the diagnosis of RBD, in order to ascertain whether RBD features remain stable over time. The possible remission of RBD with the progression of PD would question indeed its reliability as prognostic bio-marker.
15978586|NCT03047395|Biological|risankizumab|Risankizumab 150 mg administered by subcutaneous injection every 12 weeks.
15978587|NCT03047382|Other|AKI Care Bundle|Patients identified as high risk of AKI by the electronic clinical prediction model will be managed with a care bundle of best practice.
15978588|NCT03047356|Behavioral|"If-then plans"|"If-then plans (or implementation intentions) involve linking in memory critical situations (e.g., temptations) with appropriate responses (e.g., substitution)"
15978589|NCT03047356|Other|Control|Exposure to critical situations (e.g., temptations) and appropriate responses (e.g., substitution) but not linked in memory
15978590|NCT03047343|Other|Retrospective data extraction in medical files|Retrospective data extraction in medical files
15978591|NCT03047330|Drug|Leuprolide Acetate|one injection of open-label intramuscular dose of leuprolide (3.75-mg depot), a gonadotropin-releasing hormone agonist that rapidly suppresses estradiol and temporarily achieves ovarian suppression.
15978592|NCT03047330|Other|Fragmented sleep|Fragmented sleep will be experimentally induced.
15978593|NCT03047317|Biological|MABp1|Single dose of intravenous MABp1
15978594|NCT03047304|Diagnostic Test|Trans abdominal sonography|Trans abdominal sonography in order to measure fetal PR interval.
15978595|NCT03047291|Drug|Probiotic|30 probiotic tablets were given after the mechanical debridement of implants with mucositis and periimplantitis.
15978596|NCT03047291|Device|Placebo Oral Tablet|30 placebo tablets were given after the mechanical debridement of implants with mucositis and periimplantitis.
15978597|NCT03047278|Procedure|Serial Blood Samples|Serial blood samples were collected at times 0, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 24 and 36 hours after gabapentin administration, for all patients.
15978598|NCT03047278|Procedure|Serial Urine Samples|Serial urine samples were collected at intervals 0-8 hours, 8-16 hours, 16-24 hours and 24-36 hours after gabapentin administration, for all patients.
15978599|NCT03047278|Drug|Gabapentin 300 mg|All patients were treated with oral single dose of gabapentin 300 mg.
15978600|NCT03047278|Drug|Cetirizine Hydrochloride 10 mg|Patients of control group were treated with cetirizine hydrochloride, 10 mg, twice as day, orally, for five days.
15978601|NCT03047265|Drug|Paclitaxel|Paclitaxel 135mg / m2 D1, DDP 20mg / m2 D1-4, D1,D29 of RT, a total of 2 courses.
15978602|NCT03047265|Drug|Cisplatin|Cisplatin 100mg / m2 , D1,D22,D43 of RT, a total of 3 courses.
15978603|NCT03047252|Device|Home-based rehabilitation with a digital biofeedback system|"The system will be used independently by the patients to perform rehabilitation sessions at home, under remote monitoring from the clinical team. A tailored rehabilitation program will be prescribed, based on the following principles:
~STAGE 1 (Weeks 0-2) Open kinetic chain exercises without added resistance: lying, sitting and standing (with support) Strengthening of hip flexors and extensors Ice pack application after each session and throughout the day as needed STAGE 2 (weeks 3-6) Open kinetic chain exercises with added resistance, progressing to closed kinetic chain exercises, with strengthening of knee flexors and extensors and knee stabilization Progression to standing exercises without support lying, sitting and standing (with support) Exercises with steps Ice pack application after each session and throughout the day as needed STAGE 3 (Weeks 7-8) Eccentric strengthening exercises Exercises involving steps Multi-directional exercises"
15978637|NCT03046927|Drug|Ergocalciferol|Each subject on the experimental arm will receive one capsule of ergocalciferol per week for 2 months; and then once every 2 weeks for 10 months
15978604|NCT03047252|Other|Conventional Home-based rehabilitation|"Patients will perform 3 weekly rehabilitation sessions, with a duration of 1 hour, for 8 weeks, provided by a physical therapist. The rehabilitation program will respect the following principles:
~STAGE 1 (Weeks 0-2) Soft tissue massage Active assisted mobilisation of the knee to increase range of motion Gait training with bilateral support Open kinetic chain exercises without added resistance Strengthening of hip flexors and extensors Ice pack application STAGE 2 (weeks 3-6) Soft tissue massage Active assisted mobilisation of the knee to increase range of motion Open kinetic chain exercises with added resistance, progressing to closed kinetic chain exercises, with strengthening of knee flexors/ extensors and knee stabilisation Gait training with progressive withdrawal of external support Ice pack application STAGE 3 (Weeks 7-8) Eccentric strengthening exercises Exercises involving steps Weight-bearing exercises on uneven surfaces Ice pack application"
15978605|NCT03047239|Device|SENSIMED Triggerfish|Smart contact lens based device indicated to detect the peak patterns of variation in intraocular pressure over a maximum period of 24 hours
15978606|NCT03047226|Other|next-generation sequencing|Use next-generation sequencing to test germline mutation and microsatellite instability.
15978607|NCT03047213|Drug|Sapanisertib|Given PO
15978608|NCT03047200|Biological|Islet cell transplantation|The process is based on the enzymatic isolation of the pancreatic islets of Langerhans from an organ procured from a cadaveric donor; the islets obtained are injected into the liver of the recipient via percutaneous catheterization of the portal venous system . This procedure allows the selective transplantation of the insulin-producing cell population avoiding open surgery as well as the transplantation of the duodenum and the exocrine pancreas and their related morbidity.
15978609|NCT03047187|Diagnostic Test|ACLR|"quadriceps and hamstring isometric muscles test
~single hop for distance
~IKDC, KOOS, Tampa and ACL-RSI Questionnaires"
15978610|NCT03047174|Other|Mepitel® Film|Mepitel® Film is a gentle, sterile, transparent, breathable film dressing consisting of polyurethane film coated with a special contact layer. The film dressing is supported with a paper frame for ease of application. Mepitel® Film is an ultra thin, transparent, breathable soft silicone film dressing.
15978611|NCT03047174|Other|Standard Care|"Cream: Fatty cream with 2-5% urea is applied to the irradiated skin 3-4 times daily.
~Mometasone furoate cream: In addition to the fatty cream with 2-5% urea, mometasone furoate cream (solution 0.1%) is applied to the irradiated skin once daily."
15978612|NCT03047161|Device|fetal MCG|assess fetal heart rate and rhythm
15978613|NCT03047148|Other|Data mining from records|The relevant data for this investigation is extracted from the patient records database as well as from the assessment results of the ongoing quality control process that were collected by the nursing staff of the postoperative recovery units.
15978614|NCT03047135|Drug|Olaparib|Olaparib will be dispensed to patients on Day 1 and every 28 days thereafter until the patient completes the study, withdraws from the study or closure of the study.
15978615|NCT03047109|Drug|Phenylephrine|30 patients will receive Phenylephrine 30 µg/minute by syringe pump infusion for 30 minutes.
15978616|NCT03047109|Drug|Ephedrine|30 patients will receive Ephedrine 3 mg/ minute by syringe pump infusion for 30 minutes.
15978617|NCT03047096|Drug|hyaluronic acid|intra-Articular injection
15978618|NCT03047096|Drug|hyaluronic acid and corticosteroids|intra-Articular injection
15978619|NCT03047083|Other|Treatment patterns among AML patients|This is a retrospective cohort study of AML patients with or without FLT3 mutation who were exposed to treatments for AML per treating physician's decision between 1 January 2013 and 31 December 2015.
15978620|NCT03047083|Other|AML-related healthcare resources|This is a retrospective cohort study of AML patients with or without FLT3 mutation who were exposed to treatments for AML per treating physician's decision between 1 January 2013 and 31 December 2015.
15978621|NCT03047070|Drug|Lidocaine|IV Lidocaine infusion
15978622|NCT03047070|Drug|Normal saline|IV normal saline infusion
15978623|NCT03047057|Drug|Lidocaine|IV Lidocaine infusion
15978624|NCT03047057|Drug|IV normal saline|IV normal saline infusion
15978625|NCT03047044|Other|Optimizing basal infusion (B.I)|In the intervention group, the optimizing B.I PCA mode will be setted. This mode is setted that the amount of administered drug per hour will be increased by 0.3 ml by pressing bolus button (The interval: ~ 8 hr: 2 - 4 ml, 8-24 hr: 1 - 3 ml, 24 hours ~ : 0.5 - 2.5 ml). Conversely, if the bolus button is not used for 90 minutes, the administered amount of drug per hour is setted to be reduced by 0.1 ml, and the maximum (or minimum) allowable flow rate is 4 ml (or 0.5 ml).
15978626|NCT03047044|Other|Conventional PCA mode|Mode setting; total volume: 150 ml, flow rate: 2 ml, bolus volume: 0.5 ml, and LOT: 10 minutes
15978627|NCT03047018|Behavioral|The Changing Health in Autism through Nutrition, Getting fit and Expanding variety (CHANGE) Program|The CHANGE program is a a six-month long intervention consisting of 16 sessions. The first 10 sessions occur weekly while the remaining 6 sessions occur bi-weekly. Sessions last about 1 hour each. Nutrition intervention focuses on decreasing excess calories from liquids and solids and creating a balanced meal plan. Physical activity intervention uses fading strategies to increase participation in exercise. Behavior strategies promote success with meeting goals. Problem-solving techniques address challenges to adherence with implementing the program in the home setting. The standardized protocols include educational handouts, clinic-based activities and assessment procedures, and caregiver-directed homework and data collection.
15978628|NCT03047005|Drug|NB medication (Naltrexone Bupropion combination)|NB medication
15978629|NCT03047005|Other|Placebo|Placebo
15978630|NCT03046992|Drug|YH25448|"Dose Escalation: YH25448 20mg~320mg, PO
~Dose Expansion: YH25448 40mg~240mg, PO
~Dose Extension: Recommended Dose 240mg of YH25448"
15978631|NCT03046979|Drug|Apatinib|500mg, once a day, oral of each 28 day cycle. Number of cycle: until progression or unacceptable toxicity develops.
15978632|NCT03046966|Procedure|Intervention: Receives Training|"• Complete a Hands-on Intubation in the Simulation Lab with PI instructing:
~Using state of the art technology, a Storz C-MAC video laryngoscope
~Identifying anatomical landmarks
~Practice on the manikin until intubation occurs within 15 seconds"
15978633|NCT03046966|Other|Intervention: Control No Training|• Does not receive simulation training with PI. Only standard training.
15978634|NCT03046953|Drug|Avelumab|anti-PDL1 antibody
15978635|NCT03046940|Other|Patient-centered style of communication|Different doctor-patient communication
15978636|NCT03046940|Other|Doctor-centered style of communication|Different doctor-patient communication
15978638|NCT03046927|Other|Placebo|Each subject on the placebo arm will receive one capsule of placebo per week for 2 months; and then once every 2 weeks for 10 months
15978639|NCT03046914|Genetic|HLA-B*5801 test|Check whether a participant has HLA-B*5801 allele or not, before administration of allopurinol
15978640|NCT03046901|Drug|Vancomycin|Vancomycin belongs to the family of medicines called antibiotics.When taken by mouth, is used to treat Clostridium difficile-associated diarrhea (also called C diff). C diff is a type of bacteria that causes severe diarrhea. Oral Vancomycin is also used to treat enterocolitis caused by a certain bacteria (e.g., Staphylococcus aureus). Subjects enrolled in the study will take 500 mg capsule, 3 times per day for 3-12 weeks.
15978641|NCT03046888|Procedure|Robot assisted pyelolithotomy|A 12-mm camera port is placed at the level of the umbilicus and lateral; this port is moved farther laterally in morbidly obese patients to allow for the instruments to reach the target organs. Two 8-mm robotic trocars are placed under direct vision and a 12-mm assistant port is placed in the midline a 5-8 cm above the umbilicus. For right-sided stones, an additional 5-mm port is placed in the midline just below the xiphoid process for liver retraction. Placement of the trocars can be changed according to surgeon preference. After reflecting the colon medially, the renal pelvis will be dissected and identified, a flexible cystoscope will be inserted via an assisted trocar and introduced into the renal pelvis through a minor incision. The kidney stones will then be extracted with a basket and either removed via the port or placed in a specimen retrieval bag.
15978642|NCT03046875|Other|Transcutaneous Spinal Cord Stimulation|Transcutaneous Spinal Cord Stimulation is a non-invasive mechanism to enhance excitation of spinal neural circuitry and represents a promising supplement to existing physical therapy programs. Transcutaneous Spinal Cord Stimulation will be applied (via the Vectra Neo) using a 5cm x10cm oval electrode placed midline on the skin between spinous process T11 -T12 as a cathode and two 7.5cm x 13cm rectangular electrodes placed symmetrically on the skin over the lower abdomen as anodes.7,9 A symmetrical biphasic rectangular waveform, at 50Hz and 1millisecond, will be used to provide 30 continuous minutes of stimulation.
15978643|NCT03046875|Other|Sham stimulation|Sham procedures, well documented in Transcranial DC Stimulation (tDCS), will be used. Electrodes will be placed as they are in the Transcutaneous Spinal Cord Stimulation condition. Stimulation will be applied at subject's maximum intensity for 30 seconds and then discontinued.
15978648|NCT03046849|Other|next-generation sequencing|Use next-generation sequencing to test germline mutation.
15978649|NCT03046836|Drug|Oxytocin|40 IU oxytocin nasal spray
15978650|NCT03046836|Drug|Placebo|Saline
15978651|NCT03046810|Device|Wellness toileting system|This group will use the wash, dry, cleanse, and apply zinc oxide barrier spray routinely for all toileting.
15978652|NCT03046797|Device|Fibroptic intubation through Boussignac valve opening|After patients being put in HELP position to facilitate both ventilation and intubation, mask ventilation will be continued and FOB intubation will be performed from Boussignac valve opening.
15978653|NCT03046797|Device|Classic Fibroptic intubation|After patients being put in HELP position to facilitate both ventilation and incubation, mask ventilation will be terminated then FOB intubation will be done by an experienced anesthetist.
15978654|NCT03046784|Other|haemodynamic evaluation|continous haemodynamic monitoring is performed with digital Nexfin captor in two positions. in the same time transthoracic cardiac ultrasonography is performed to calculate cardiac output using velocity time index of aortic outflow chamber.
15978655|NCT03046771|Behavioral|Transport PLUS group|The Transport Plus EMTs will offer to perform the FHA and DCA for all transports of patients aged 65 or older, who are being transported from The Mount Sinai Hospital to a private residence.
15978656|NCT03046758|Drug|A combination of fosfomycin, metronidazole and GM-CSF i.p.|All drugs will be administered together intraperitoneally at the end of the surgery after the appendix has been removed.
15978657|NCT03046732|Other|"Implementing Explore Transplant Education"|"The Explore Transplant Ontario (ETO) education program"
15978658|NCT03046719|Drug|Bupivacaine 0,5%|Bupivacaine 0,5% was given on the subconjunctiva, in between stitches by the surgeon after finishing the last stitches
15978659|NCT03046719|Drug|NaCl 0,9%|NaCl 0,9% was given on the subconjunctiva, in between stitches by the surgeon after finishing the last stitches
15978660|NCT03046706|Behavioral|post operative voice rest|After surgery, a week of total silence. In the second week after surgery talking is allowed for 20 minutes a day.
15978661|NCT03046706|Behavioral|No voice rest|No limitations regarding post operative speech. Members can talk indefinitely after surgery with no special restrictions
15978662|NCT03046693|Drug|Group A Citicoline 1000 mg oral tablet|Citicoline 1000 mg will be repackaged and given to Group A for 60 days
15978663|NCT03046693|Drug|Group B placebo oral tablet|Placebo will be repackaged and given to Group B for 60 days
15978664|NCT03046680|Other|Health Coaching|
15978665|NCT03046680|Other|Multiprofessional Team|
15978666|NCT03046667|Dietary Supplement|Barley β-glucan|The test beverages with Barley β-glucan is consumed by the participants for the first time at the trial site, followed by a 1 week running-in period were the participants was ingesting half a dose of test drinks. Subsequent were a full dose of the test drinks consumed for 5 weeks. In total was the test drinks consumed for 6 weeks.
15978667|NCT03046667|Dietary Supplement|Control|The control beverages is consumed by the participants for the first time at the trial site, followed by a 1 week running-in period were the participants was ingesting half a dose of test drinks. Subsequent were a full dose of the test drinks
15978668|NCT03046654|Diagnostic Test|Trans vaginal sonography|Trans vaginal sonography performed once every 4 weeks from the time of cerclage placement until the time of cerclage removal to evaluate cerclage position and distance from internal and external os'.
15978669|NCT03046654|Diagnostic Test|Vaginal examination|Vaginal examination performed once every 4 weeks from the time of cerclage placement until the time of cerclage removal to evaluate cervical conditions including cervical dilatation, cervical effacement and pressure on the cerclage.
15978776|NCT03045770|Drug|Fluorouracil|Fluorouracil was used as first line treatment with AGC.
15978670|NCT03046654|Diagnostic Test|Speculum examination|Speculum examination performed once every 4 weeks from the time of cerclage placement until the time of cerclage removal to evaluate cerclage position and vaginal bleeding.
15978671|NCT03046641|Other|Continuous training|Study group I (42 participants) received the continuous training.
15978672|NCT03046641|Other|The interval training|Study group II (40 participants) received the interval training.
15978673|NCT03046628|Device|TcPO2|
15978674|NCT03046628|Device|Green laser (at 532nm) and a fast camera|
15978675|NCT03046615|Device|EEG Electrode Patch|The additional electrodes are modified EEG electrodes (used in clinical practice on the head already) placed in a silicone molding. These are placed lateral to the eye with the patient asleep. These are then wired to the same recording apparatus that we would commonly use for recording.
15978676|NCT03046615|Device|Standard Needles|Needles are placed in the muscles surrounding the eye to measure eye movements.
15978677|NCT03046589|Drug|DP13|dose escalation
15978678|NCT03046589|Drug|placebo|control to dose-escalation
15978679|NCT03046576|Diagnostic Test|plasma DPP4 activity|DPP4a was determined by enzymatic assays.
15978680|NCT03046563|Other|Acupressure and Abdominal Massage|Pressing the Hegu (LI 4), Zusanli (ST 36) , Tianshu(ST 25) and abdominal massage for eight minutes
15978681|NCT03046563|Other|Pressing the Sham points|Pressing the sham points for eight minutes
15978682|NCT03046550|Drug|NTM-1634|NTM-1634 drug product is a mixture of four human monoclonal IgG1 antibodies. Three dose cohorts (A: 0.33 mg/kg B: 0.66 mg/kg, and C: 1 mg/kg).
15978683|NCT03046550|Drug|Placebo|placebo
15978684|NCT03046537|Diagnostic Test|Breath test|Collecting breath test from participants
15978685|NCT03046524|Other|Chart Review|Data between the years of 1/1/2002 and 12/31/2013 analyzed.
15978686|NCT03046511|Drug|Cefazolin|A post- procedure administration of Cefazolin will be compared with a pre-operative intravenous dose
15978687|NCT03046498|Behavioral|Evidence-Based Program|DSMP and DPP
15978688|NCT03046485|Behavioral|Self management program 'Living with Vision Loss'|group met for 6 weeks, 2 hours per week, to discuss strategies for living with low vision
15978689|NCT03046472|Other|Physical Therapy treatment for Postural Behavior|"Physical Therapy treatment for Postural Behavior: intervention program will include physical awareness by using a mirror and practice for good posture, and exercises for flexibility, strength and muscle endurance.
~All participants will get 10-15 minutes of exercise for performing every day."
15978690|NCT03046459|Biological|BNZ132-1-40|pegylated peptide inhibiting IL-2, IL-9 and IL-15
15978691|NCT03046446|Drug|FX006 32 mg|Single intra-articular injection
15978692|NCT03046420|Other|Chart review|This is a retrospective chart review study. The charts of patients who meet the inclusion criteria will be abstracted into a standardized electronic case report form, as described in Section 5. A standardized case report form for each patient will be created so as to collect uniform data. Charts data for one year back to the start date of data abstraction will be included in the study
15978693|NCT03046407|Biological|retinal pigment epithelium transplantation|Transplant retinal pigment epithelium derived from human embryonic stem cells into subretinal space of patients with dry age-related macular degeneration(dry AMD).
15978694|NCT03046394|Device|C-SACH|Solid Ankle Cushion Heel by Otto Bock, advertised for activity category 1
15978695|NCT03046394|Device|B-DER|Dynamic Motion by Otto Bock, advertised for activity category 2-3
15978696|NCT03046394|Device|A-DER|Triton by Otto Bock, advertised for activity category 3-4
15978697|NCT03046381|Drug|Tocilizumab|Tocilizumab 162mg 1x weekly s.c.
15978698|NCT03046368|Behavioral|Targeted cover letter|The intervention Group will receive a cover letter with targeted content with the purpose of increasing participation
15978699|NCT03046355|Procedure|Labor induction at 37.0 to 37.6 weeks of gestation|Diagnosis of FGR with induction at 37 weeks 0 days of gestation to 37 weeks and 6 days
15978700|NCT03046355|Procedure|Expectant monitoring until delivery|Diagnosis of FGR managed with expectant monitoring and delivery as indicated
15978701|NCT03046342|Diagnostic Test|Molecular method (PCR)|"Stool samples are being processed through molecular method (PCR) for children with GE.
~Epidemiology of acute Gastroenteritis in the pediatric population in Qatar"
15978702|NCT03046329|Behavioral|Carevive CPS|This intervention will focus on the use of the Carevive CPS at the point of care to enable providers to deliver evidence-based and personalized supportive care and symptom management plans to their MM patients receiving active treatment. The Carevive CPS collects electronic patient reported outcomes (ePROs) and clinical data, reported and entered by clinical staff and/or extracted from the electronic medical record (EMR), and uses these to auto-generate the personalized care plans. Care plan content is driven by practice guidelines and other peer-reviewed evidence, and includes patient education, resources, and referrals developed by expert cancer clinicians and researchers.
15978703|NCT03046316|Other|local consolidative treatment|local consolidative treatment to primary or metastases, which includes surgery, radiotherapy or interventional therapy
15978704|NCT03046303|Procedure|ERAS|optimized pain control, restricted I.V. fluids, early initiation of post-operative oral feeding and enforced mobilization
15978705|NCT03046290|Procedure|circumcision|
15978706|NCT03046290|Drug|Lidocaine|
15978707|NCT03046290|Drug|Ropivacaine|
15978708|NCT03046277|Other|No intervention|No intervention
15978709|NCT03046251|Drug|Natalizumab|
15978710|NCT03046238|Drug|Dexmedetomidine|preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine plus Dexmedetomidine (1 µg/kg)
15978711|NCT03046238|Drug|placebo|preoperative ultrasound guided modified Pecs block with 30 mL of 0.25% bupivacaine
15978712|NCT03046225|Device|Transcutaneous electrical nerve stimulation|TENS was applied in the conventional mode, through two self-adhesive electrodes of size 5x9cm positioned parallel to the lumbar spine, on the nerve roots of L3, L4 and L5, with frequency of 100 Hz and pulse duration of 100 μs, for 30 minutes. The intensity was adjusted according to the maximum tolerance of the patient and was gradually increased, with his permission, during the application time.
15978713|NCT03046225|Device|Continuous passive movement device|CPM device was used for 30 minutes and realized continuous passive flexion and extension of the operated knee.
15978777|NCT03045770|Drug|Oxaliplatin|Oxaliplatin was used as first line treatment with AGC.
15978778|NCT03045770|Drug|Irinotecan|Irinotecan was used as first line treatment with AGC.
15978714|NCT03046225|Other|Exercises|Active exercises of plantar flexion and dorsal flexion of the ankles, adduction and abduction of the hips and flexion and extension of the operated knees. All exercises were performed in 10 repetitions, with the patient positioned in the supine position in the bed.
15978715|NCT03046212|Device|Transcutaneous electrical nerve stimulation|TENS: it was applied in the conventional mode, through four self-adhesive electrodes of size 5x9cm positioned about five centimeters from the edges of the surgical scar, with frequency of 100 Hz and pulse duration of 100μs, for 30 minutes. The intensity was adjusted according to the maximum tolerance of the patient and was it increased during the application time with their permission.
15978716|NCT03046212|Other|Exercises|Active exercises of plantar flexion and dorsal flexion of the ankles, flexion and extension of the knees and adduction and abduction of the hips, in both lower limbs. All exercises were performed with the patient in the supine position in the bed, in 10 repetitions.
15978717|NCT03046199|Other|Questionnaire|Targeted screening of COPD by GPs via the GOLD / HAS questionnaire. The questionnaire includes 4 questions for patients over 40. At least one positive response is an indication to perform a spirometry.
15978718|NCT03046199|Other|Coordination|Information of the GPs of the existence of a coordination of the care of proximity to facilitate the access to the spirometry (identification of a referent specialist, making appointments).
15978719|NCT03046186|Diagnostic Test|Mixed meal test with double tracer technique|
15978720|NCT03046173|Other|concentrated growth factors|These patients were randomly assigned to receive concentrated growth factors, hydroxyapatite and autogenous bone at bone defect sites in the experimental group.
15978721|NCT03046173|Other|hydroxyapatite and autogenous bone|These patients were randomly assigned to receive hydroxyapatite and autogenous bone at bone defect sites in the control group.
15978722|NCT03046160|Other|Manual therapy (Mobilization with movement)|grade III mobilizations with movement, performed in sitting for 6-10 repetitions for 3 sets
15978723|NCT03046160|Other|neck and scapular exercises.|A program of 12 neck and scapular exercises.
15978724|NCT03046160|Other|corrective tape|elastic tape used to correct the anterior tilt of the scapula
15978725|NCT03046147|Procedure|Roux-en-Y gastric bypass|Roux-en-Y gastric bypass surgery for morbid obesity
15978726|NCT03046134|Biological|PCV13|Conjugated pneumococcal vaccine
15978727|NCT03046121|Behavioral|Family-centered Function-focused Care (Fam-FFC)|"An educational empowerment model for family CGs that includes a care pathway, provided within a social-ecological in-patient framework promoting specialized care to patients with ADRD. The intervention creates an enabling milieu for the person with ADRD through environmental and policy assessment/modification, staff education, unit-based champions, and individualized goal setting that focuses on functional recovery during hospitalization and the immediate post-acute period."
15978728|NCT03046108|Device|blind injection of Morton neuroma|Introduction of a needle based in anatomical landmark
15978729|NCT03046108|Drug|blind injection of Mepivacaine|blind injection of 1 cc of Mepivacaine Normon 2% ®
15978730|NCT03046108|Drug|blind injection of Triamcinolone|blind injection of 40 mg of triamcinolone (trigon depot ®)
15978731|NCT03046108|Device|ultrasound guided injection|Introduction of a needle based guided by ultrasound
15978732|NCT03046108|Drug|guided injection of mepivacaine|ultrasound guided injection of 1 cc of Mepivacaine Normon 2% ®
15978733|NCT03046108|Drug|guided injection of Triamcinolone|ultrasound guided injection of 40 mg of triamcinolone (trigon depot ®)
15978734|NCT03046095|Other|Unilateral Resistance Exercise|Unilateral Resistance exercise will include training three days per week and each session will include 3 sets of leg extension and 3 sets of leg press. In each set, the participant will complete a maximum of 12 repetitions.
15978735|NCT03046095|Procedure|Immobilization|During the last two weeks of the study (week 8-10), a Don Joy adjustable knee brace will be applied to the participant's leg randomized to immobilization. The brace will be applied at a 40 degree angle relative to complete extension.
15978736|NCT03046082|Drug|Antibiotics|Observation of antibiotic types given to patients with pneumonia.
15978737|NCT03046069|Other|Telephone interviews|Qualitative concept elicitation telephone interviews will be conducted in subjects with COPD to explore treatment effectiveness, symptoms, quality of life, and features of treatment that are considered to be most important to them when making treatment choices.
15978738|NCT03046069|Other|In-person focus groups|Qualitative concept elicitation in-person focus groups will be conducted in subjects with COPD to explore treatment effectiveness, symptoms, quality of life, and features of treatment that are considered to be most important to them when making treatment choices.
15978739|NCT03046069|Other|DCE surveys- cognitive interviews|Draft version of the DCE surveys will be tested with subjects in cognitive interviews to explore the saliency of the attribute choices and assess whether the attributes are understandable, meaningful and comprehensive.
15978740|NCT03046069|Other|Modified DCE|The modified DCEs will be piloted with subjects with COPD in each country to refine the underlying design and ensure that information is collected in an efficient way to enable the statistical analysis to be as precise as possible.
15978741|NCT03046069|Other|Online DCE survey|An online DCE survey questionnaire will be given to the subjects to identify subject preferences, priorities and treatment goals.
15978742|NCT03046056|Drug|Filgotinib|Tablet(s) administered orally once daily
15978743|NCT03046056|Drug|Placebo to match filgotinib|Tablet(s) administered orally once daily
15978744|NCT03046043|Procedure|pulmonary vein isolation|pulmonary vein isolation is conducted on the junction between the left atrium and pulmonary vein
15978745|NCT03046043|Procedure|Low-Voltage & CFAE guided ablation|In CFAE guided ablation,. Within low voltage zone, CFAE areas defined by shortest SCI and high ICL are identified.-Areas with the shortest SCI and high ICL within low voltage areas should be targeted first, followed by longer SCI regions (up to 120ms). Radiofrequency energy is delivered at target sites for 30-60 sec until the local electrogram is completely eliminated.
15978746|NCT03046030|Other|Real acupuncture|Verum acupuncture will be applied on the right SP6 and SP9. For each subject, leg position, acupoint location, and needling parameters (1-2 cm depth, 120 rotations / minute, 90˚ insertion angle, moderate deqi sensations on a 0-10 scale) will be kept constant. For the low dose acupuncture group, needles will be rotated at one point and then the other in 15-second rotations with 20-30 second breaks. The specific starting acupoint will be randomized across subjects but kept consistent for each subject across sessions.
15978747|NCT03046030|Other|Sham acupuncture|Placebo acupuncture will be applied at two sham points using specially designed sham acupuncture needles [20, 35, 104-106]. The sham needles differ from regular needles by possessing blunt and retractable tips. Instead of penetrating the skin, the point of the Streitberger needle retracts up the handle shaft when the acupuncturist presses it against the skin. This sham device has been validated by studies showing that subjects cannot distinguish between genuine and sham needling [20, 35, 104]. Two sham points will be used during placebo acupuncture: sham point 1 is located 1 cun posterior to the superior 1/3 of K9 and K10. Sham 2 is located 1 cun posterior to K8. Both points are located on the leg where there is no meridian passing through. Sham acupuncture treatment will be the same as verum acupuncture.
15978748|NCT03046030|Other|VGAIT|In Session 1, all patients will first be introduced to acupuncture treatment, particularly the sensation evoked by acupuncture needles. This will be followed by a five-minute acupuncture exposure applied by a licensed acupuncturist. The exposure will include multiple acupuncture needle manipulations across the two acupoints (SP 6 and SP 9) used in this study. The paradigm applied will be identical to real acupuncture treatment, and the procedure will also be video recorded for the following session. At the beginning of the VGAIT session, patients will be trained for imagery acupuncture outside the fMRI scan. Subjects will first read a script introducing the imagery acupuncture treatment. Then, VGAIT will be applied during scanning. Identical to the acupuncture treatment, there are two fMRI scans during VGAIT, each lasting about 10 minutes. We will ask the patient to measure the sensations they feel during treatment using the MGH Acupuncture Sensation Scale (MASS) after treatment.
15978749|NCT03046030|Other|VGAIT control|The control condition will be the same as VGAIT, except we will use cotton swabs repeatedly touching at non-acupoints with a frequency of about 1 Hz using the same paradigm of verum / sham acupuncture. They will also read a script describing what they are about to see. Then, VGAIT control will be applied during scanning. We will ask the patient to measure the sensations they feel during treatment using the MASS after treatment.
15978750|NCT03046017|Device|tDCS|Electrical stimulation will be applied on the head to temporarily influence brain activity in specific regions.
15978751|NCT03046017|Other|Lidocaine cream|Lidocaine cream will be applied to reduce pain sensitivity (analgesia).
15978752|NCT03046017|Other|Control cream|A neutral cream will be applied as a control.
15978753|NCT03046004|Other|Decision aid for breast cancer screening|Women in the intervention arm will receive a leaflet with detailed information on the benefits (breast cancer mortality reduction, less intensive treatments) and harms (false positive results and overdiagnosis).
15978754|NCT03046004|Other|Standard leaflet|Women in the control arm will receive a standard leaflet that does not mention harms and recommends accepting the invitation to participate in the biennial exams of the EDBCP.
15978755|NCT03045991|Behavioral|aerobic exercise training|The aerobic exercise program using progressive resistive stationary bicycle training which will contain warm-up, resistive physical exercise, and cool-down. The training resistance will increase with improvement of participants' performance.
15978756|NCT03045991|Behavioral|control training|The control training program will receive 30 minutes non-aerobic exercise training, including stretching muscle skills, joint mobility exercises; in addition to one 30-minute session of unstructured mental activities, such as reading books or reading educational films.
15978757|NCT03045991|Behavioral|cognitive training|The computerized cognitive training program will be implemented with the brainHQ to target abilities of visuospatial processing, attention, memory, and executive function. The level of the training program will become more difficult with progress in participants' targeted cognitive abilities.
15978758|NCT03045965|Procedure|Salpingectomy|The intervention is a routine salpingectomy, performed laparoscopically, through laparotomy or vaginally.
15978759|NCT03045952|Procedure|microwave ablation device|Microwave ablation is a technique that uses thermal therapy to induce complete necrosis of tumor in situ by using microwave ablation device.
15978760|NCT03045939|Device|cervical ripening device|insertion of the double balloon device for 12 hours (standard care) vs 6 hours, following oxytocin IV infusion according local protocol guidelines as mentioned above
15978761|NCT03045926|Drug|Diosmectite (Smecta®)|
15978762|NCT03045913|Device|Genoss DES|The Genoss DES (Genoss, Korea) L-605 cobalt chromium (CoCr) platform with a strut thickness of 70 µm Sirolimus drug with concentration of 1.15µg/mm2 Abluminal biodegradable PLA and PLGA polymers.
15978763|NCT03045900|Other|Shaded bulk-fill resin composite|Dental bulk-fill resin composite with shades A1, A2, A3
15978764|NCT03045887|Drug|GSK2292767 50 μg|GSK2292767 50 μg blended with lactose and magnesium stearate per blister as powder for inhalation
15978765|NCT03045887|Drug|GSK2292767 500 μg|GSK2292767 500 μg blended with lactose and magnesium stearate per blister as powder for inhalation
15978766|NCT03045887|Drug|Placebo|Lactose as powder for inhalation
15978767|NCT03045861|Drug|GSK2838232|GSK2838232 capsules will be supplied as swedish orange, unmarked capsule (50 mg), and white, unmarked capsules (10 mg) in high-density polyethylene bottles.
15978768|NCT03045861|Drug|Cobicistat|Cobicistat tablets 150 mg will be supplied as an orange, round, biconvex, film-coated tablet in bulk containers for individualized dosing.
15978769|NCT03045848|Device|Biofreedom drug-coated stent|BioFreedom (Biosensors International Technologies, Singapore) is the only polymer- and carrier-free drug coated stent with Biolimus A9 in a selectively micro-structured abluminal surface. It is a stainless steel bare metal surface with 120 micron thick corrugated ring strut.
15978770|NCT03045835|Device|BASKA mask|Baska mask will be inserted during induction of anaesthesia and once patient is in an adequate anaesthetic depth
15978771|NCT03045835|Device|Endotracheal intubation|Endotracheal intubation will be carried out during induction of anaesthesia and once patient is in an adequate anaesthetic depth
15978772|NCT03045822|Drug|Bioimpedance analysis|
15978773|NCT03045809|Diagnostic Test|Urogenital infection point-of-care tests|Instead of syndromic management of symptomatic women, the study offers screening of high risk women regardless of symptoms using point-of-care tests for HIV, TV, and BV (all women), syphilis, NG, and CT (when risk score positive), and UTI (when symptomatic).
15978774|NCT03045796|Device|Oxygen Saturation measured by WristOx|Patients will be hooked up to finger cuffs as well as ECGs to monitor oxygen saturations in different part of the body.
15978775|NCT03045783|Drug|Cefotiam|Prophylactic use of antibiotics group：Prophylactic use of antibiotics during endoscopic treatment, cefotiam 2.0g intravenous
15978781|NCT03045744|Device|long-term paired associative stimulation|Paired associative stimulation (PAS) administered 3 times per week. PAS comprises transcranial magnetic stimulation (eXimia magnetic stimulator, Nexstim Ltd, Helsinki, Finland) and peripheral nerve stimulation (given with Dantec Keypoint® electroneuromyography device (Natus Medical Incorporated, Pleasanton, CA, USA)).
15978782|NCT03045718|Behavioral|Horticultural Therapy|The Horticultural Therapy intervention will be delivered by trained facilitators at the Therapeutic Garden at Hort Park, and consists of 1 hour sessions weekly for 9 months. The Horticultural Therapy program is designed to stimulate the senses through interaction with the tasks and the environment, promote social interaction and also to promote a sense of self-worth through completion of projects. It encompasses a range of activities including general gardening and also project-based craft activities.
15978783|NCT03045705|Behavioral|Routine pain management|Women that will be asked according to the routine management regarding pain management during labor, meaning frequent inquiries regarding the woman's wishes to receive analgesia by the medical team.
15978784|NCT03045705|Behavioral|No inquiry regarding analgesia|women will not be asked about analgesia during labor by the medical team, but will be able to receive the modality of choice at the time of choice.
15978785|NCT03045692|Diagnostic Test|kidney function assessment by 4 hour creatinine clearance|4 hour creatinine clearance is used to decide colistin maintenance dosage.
15978786|NCT03045692|Diagnostic Test|kidney function assessment by creatinine based eGFR|creatinine based eGFR (which is not revised value with standardized body surface area, that is, 1.73m2) are used to decide colistin maintenance dosage.
15978787|NCT03045679|Other|RYGB|laparoscopic RYGB
15978788|NCT03045679|Other|OAGB/MGB|laparoscopic OAGB/MGB
15978789|NCT03045666|Other|Exercise program|patients who are stable on Macitentan therapy (received in both groups before enrollment) and will exercise at a pulmonary rehabilitation program twice a week for 12 weeks
15978790|NCT03045653|Drug|Tamoxifen Oral Product|Tamoxifen 100 mg/d or high-dose Tamoxifen(100 mg/d ) plus chemotherapy
15978791|NCT03045640|Other|FSI ECD|The FSI ECD intervention was delivered in a structured curriculum format, covering a range of topics from health, water and sanitation, good hygiene, early stimulation, conflict resolution, to good communication. It was designed to improve vulnerable households home environment and engagement with their children in order to improve child development outcomes. The curriculum was delivered by bachelor-level trained staff with beneficiaries on an individual, one on one basis, using active coaching to promote child well being and behaviors with caregivers.
15978792|NCT03045627|Drug|AraC|ARA-C subcutaneously in a 12-hour infusion on days 1 through 14
15978793|NCT03045627|Drug|Aclarubicin|Aclarubicin(Acla) 5～7mg/m2/d，intravenously on days 1 through 8
15978794|NCT03045627|Drug|Peg-G-CSF|PEG-G-CSF 6mg subcutaneously on days 0.
15978795|NCT03045627|Drug|G-CSF|G-CSF 200 μg·m-2·d-1, subcutaneously on days 0 through 14.
15978796|NCT03045614|Other|No intervention|No intervention
15978797|NCT03045601|Diagnostic Test|CT-FFR|Invasive FFR and CCTA With CT-FFR
15978798|NCT03045601|Diagnostic Test|Stress echocardiography|Stress echocardiography and invasive FFR
15978799|NCT03045588|Other|Combined exercise and diet intervention|Both groups exercise 6 times per week in 4 weeks conducted as 3 evening and 3 morning sessions per week. Both groups receive dietary products to be consumed immediately before and after each evening and morning session, respectively. One group conduct morning sessions in a fasted state, the other conduct the morning sessions in a fed state. Performance pre and post is measured, and muscle biopsies are obtained.
15978800|NCT03045562|Drug|Normal saline|Patients will be assigned to receive 100ml of normal saline in catherter room setting,and following similar medicine once daily for 7 days.
15978801|NCT03045562|Drug|Salvianolate injection|Patients will be assigned to receive Salvianolate injection dissolved in 100ml of normal saline in catherter room setting,and following similar medicine once daily for 7 days.
15978802|NCT03045549|Device|Digital biofeedback system|"The system will be used independently by the patients to perform rehabilitation sessions at home, under remote monitoring from the clinical team. A tailored rehabilitation program will be prescribed, based on the following principles:
~STAGE 1 (Weeks 0-6) Open kinetic chain exercises without added resistance: lying, sitting and standing (with support) Strengthening of hip flexors and abductors (mainly) Ice pack application STAGE 2 (weeks 7-8) Open kinetic chain exercises with added resistance: lying, sitting (high chair) and standing (with progression to standing without support) Strengthening of hip flexors and abductors (mainly) Ice pack application after each session"
15978803|NCT03045549|Other|Conventional home-based rehabilitation|"Patients will perform 3 weekly rehabilitation sessions, with a duration of 1 hour, for 8 weeks, provided by a physical therapist. The rehabilitation program will respect the following principles:
~STAGE 1 (Weeks 0-6) Soft tissue massage Active assisted mobilization of the hip joint to increase range of motion (avoiding internal rotation and adduction) Gait training with bilateral assistive devices Isometric exercises progressing to open chain, low-impact, concentric exercises with strengthening of hip abductors and flexors Ice pack application STAGE 2 (weeks 7-8) Soft tissue massage Gait training with progressive withdrawal of assistive devices Balance exercises with progression to one-leg support Open-chain strengthening exercises against resistance with progression to closed-chain exercises Ice pack application"
15978804|NCT03045536|Device|MML (Fa. ESKA/Orthodynamics)|Classification of complications according to MSTS
15978805|NCT03045523|Drug|GLPG2222 150 mg q.d.|GLPG2222 150 mg administered as a ready-to-use oral suspension, once daily (q.d.) for 29 days
15978806|NCT03045523|Drug|GLPG2222 300 mg q.d.|GLPG2222 300 mg administered as a ready-to-use oral suspension, once daily (q.d.) for 29 days
15978807|NCT03045523|Drug|Placebo|Placebo administered as a ready-to-use oral suspension, once daily (q.d.) for 29 days
15978808|NCT03045510|Drug|decitabine|Decitabine 3.5mg/m2，ivdrip，qd x 5d, every four weeks for one cycle. It will be given six cycles.
15978809|NCT03045497|Drug|Perflutren Lipid Microspheres|Given IV
15978810|NCT03045497|Device|Dynamic Contrast-Enhanced Ultrasound Imaging|Undergo contrast-enhanced ultrasound imaging
15978811|NCT03045497|Device|Contrast-enhanced Magnetic Resonance Imaging|Undergo contrast-enhanced Magnetic Resonance Imaging
15978812|NCT03045484|Drug|Controlled-release oxycodone|CRO is effective for 12 h. Patient takes it only twice a day. The minimum oral unit of CRO is a 10 mg tablet, so the minimum daily dose was 10 mg.
15978813|NCT03045484|Other|Chemoradiotherapy|Radiotherapy were administered intensity modulated radiation therapy wiht a dose of 1.8-2.2Gy per fraction, 30-32 fraction for various tumor locations. Chemotherapy drugs platinum was used once a weak with 100mg/㎡.
15978814|NCT03045471|Drug|R-EPOCH|Rituximab: an anti-CD20 monoclonal antibody, which has the ability to kill B cells, be they normal or malignant; Etoposide: a topoisomerase inhibitor from the group of epipodofyllotoxins; Prednisolone: a glucocorticoid hormone that can cause apoptosis and lysis of both normal and malignant lymphocytes; Oncovin, also known as vincristine: a vinca alkaloid that binds to the protein tubulin, thereby preventing the formation of microtubules and mitosis; Cyclophosphamide: an alkylating antineoplastic agent; Hydroxydaunorubicin, also known as doxorubicin: an anthracycline antibiotic that is able to intercalate DNA, damaging it and preventing the cell division.
15978815|NCT03045471|Drug|R-CHOP|Rituximab: an anti-CD20 monoclonal antibody, which has the ability to kill B cells, be they normal or malignant; Prednisolone: a glucocorticoid hormone that can cause apoptosis and lysis of both normal and malignant lymphocytes; Oncovin, also known as vincristine: a vinca alkaloid that binds to the protein tubulin, thereby preventing the formation of microtubules and mitosis; Cyclophosphamide: an alkylating antineoplastic agent; Hydroxydaunorubicin, also known as doxorubicin: an anthracycline antibiotic that is able to intercalate DNA, damaging it and preventing the cell division.
15978816|NCT03045458|Device|tissue level dental implant|After local anesthesia, full thickness flaps were reflected, and osteotomies were prepared in the first mandibular molar sites. In these surgical operations, 20 tissue-level implants 12 mm in length and 4.8 mm in diameter were inserted in Group I. Cover screw was removed and replaced with healing abutments.
15978817|NCT03045458|Device|Bone level dental implant|After local anesthesia, full thickness flaps were reflected, and osteotomies were prepared in the first mandibular molar sites. In these surgical operations, 20 bone-level dental implants 12 mm in length and 4.8 mm in diameter were inserted inGroup II. Three months later, second-stage surgery was performed and implant exposed into the oral cavity. Cover screw was removed and replaced with healing abutments. Three months waited for second surgery in bone level implants.
15978818|NCT03045445|Diagnostic Test|Double Low-Dose protocol CT|Double low-dose protocol CT (Low radiation dose quadriphasic liver CT and low dose of iodine contrast media) at spectral dual energy CT scanner
15978819|NCT03045445|Diagnostic Test|Standard protocol CT|standard protocol CT (standard dose quadriphasic liver CT and standard dose of iodine contrast media) at spectral dual energy CT scanner
15978820|NCT03045432|Other|video-teaching|By watching a video specially designed by a rehabilitation team, the participants may learn how to position their affected arm properly (30 minutes per time, twice a day for five days in a week), how to transfer safely with the help from the caregivers, how to execute appropriate passive range of motion exercises regularly (15 minutes per time, twice a day for five days in a week), and be taught to be aware of not doing insecure pulley exercises nor carrying stuffs which are too heavy.
15978821|NCT03045432|Other|oral-teaching|The nurses will teach patients how to position their affected arm properly, how to transfer safely with the help from the caregivers, how to execute appropriate passive range of motion exercises regularly, and be taught to be aware of not doing insecure pulley exercises nor carrying stuffs which are too heavy on the admission date of hospitalization.
15978822|NCT03045432|Other|regular rehabilitation program|Regular occupational therapy program and regular physical therapy program in the rehabilitation department of the hospital.
15978823|NCT03045419|Procedure|gadoxetic acid-enhanced liver MRI|liver MRI using a standard dose (0.025mmol/kg) of gadoxetic acid
15978824|NCT03045406|Drug|Apixaban|Tablets
15978825|NCT03045406|Drug|Dalteparin|Injections
15978826|NCT03045393|Drug|Mirvetuximab Soravtansine (IMGN853)|Mirvetuximab Soravtansine is a targeted drug for tumors that express high levels of folate receptor alpha.
15978827|NCT03045380|Other|Game based physical activity training|Based on the physical levels of the patients, appropriate games will be selected and video game based physical activity training will be started. Video games will be played with Xbox One with motion sensor (Microsoft) and a 50'' Liquid Crystal Display. Depending on the prognosis of the patients, the grades of the games and types of the games will be changed. A game based physical activity training session takes 30 to 45 minutes. The program will be administered once a week for 8 weeks.
15978828|NCT03045380|Other|Conventional physiotherapy|A conventional physiotherapy program including balance, upper extremity, and core stabilization exercises will be implemented. A conventional physiotherapy session takes 30 to 45 minutes. The program will be administered once a week for 8 weeks.
15978829|NCT03045367|Procedure|Phacoemulsification, intraocular lens implant, vitrectomy.|Cataract extraction, intraocular lens implant, vitrectomy, epiretinal membrane and inner limiting retinal membrane peeling.
15978830|NCT03045354|Other|Mashed potatoes|Isocaloric (450 kcal) breakfast treatments of eggs with a side of mashed potatoes
15978831|NCT03045354|Other|Traditional breakfast|Isocaloric (450 kcal) control breakfast treatments of cereal, milk, toast and jam
15978832|NCT03045354|Other|Breakfast skipping|No breakfast
15978833|NCT03045354|Other|French fries|Isocaloric (450 kcal) breakfast treatments of eggs with a side of French fries
15978834|NCT03045354|Other|Beans|Isocaloric (450 kcal) breakfast treatments of eggs with a side of beans
15978835|NCT03045341|Drug|NB medication (Naltrexone Bupropion combination)|NB medication
15978836|NCT03045341|Behavioral|Behavioral Weight Loss (BWL) counseling|BWL counseling
15978837|NCT03045341|Other|Placebo|Placebo
15978838|NCT03045328|Drug|Ibrutinib|Administered at 420 mg/day, as oral capsules (3 x 140 mg), starting Day 1, Week 1.
15978839|NCT03045328|Drug|Venetoclax|Administered as tablets, starting Day 1, Week 9, with dose increasing every 7 days through 5 dose levels (20 mg; 50 mg; 100 mg; 200 mg; 400 mg).
15978840|NCT03045315|Other|IVF Procedure|
15978841|NCT03045302|Drug|BIM23B065|Subcutaneous twice a day or three times a day administration of BIM23B065. Dose will be 0.4, 0.6, 0.8 or 1 mg (twice a day or three times a day).
15978842|NCT03045289|Behavioral|Plant-Based Diet|Women will be provided with 3 meals daily, delivered to their home, for 8 weeks, along with a multivitamin, and will attend weekly office visits.
15978910|NCT03044691|Behavioral|ResearchACTS software|screen patients for tobacco and nicotine product use (using the anticipate and ask components of the 6As) by having youth complete a tobacco and nicotine use screening tool using the ResearchACTS software.
15978843|NCT03045276|Behavioral|Behavioral Feedback and Economic Incentives: Arm 1|"The purpose of this study is to determine the effectiveness of behavioral feedback plus economic incentives to promote treatment adherence among a large diverse population of adolescents and young adults (AYA) with kidney transplants (KT) or spina bifida (SB). In Arm 1, participants will not receive personalized feedback, nor will they receive the extra incentive of $10 for meeting their adherence goal."
15978844|NCT03045276|Behavioral|Behavioral Feedback and Economic Incentives: Arm 2|"The purpose of this study is to determine the effectiveness of behavioral feedback plus economic incentives to promote treatment adherence among a large diverse population of adolescents and young adults (AYA) with kidney transplants (KT) or spina bifida (SB). In Arm 2, participants will receive personalized feedback, and an extra incentive of $10 for meeting their adherence goal."
15978845|NCT03045263|Behavioral|Pivotal Response Treatment|Behavioral intervention for autism
15978846|NCT03045250|Device|Corneal confocal microscopy|Confocal miscroscopy will be used to assess corneal nerve changes due to hyperglycemia.
15978847|NCT03045250|Procedure|Skin biopsy|Skin biopsy will be used to assess the appearance of nerve fibers in subjects with type 1 diabetes.
15978848|NCT03045250|Procedure|Nerve conduction study|Nerve conduction studies will be use to assess for neuropathy.
15978849|NCT03045250|Other|Blood draw|Subjects will undergo a one time blood draw for biomarkers.
15978850|NCT03045237|Other|physical exercises classes|3 physical exercises classes, one of them in the pool.
15978851|NCT03045224|Device|PTA, balloon angioplasty, stent|
15978852|NCT03045211|Device|Dynamic Standing Table|The dynamic standing table is a height-adjustable standing table which gives periodic cues to the user to make stepping movements.
15978853|NCT03045198|Drug|Azithromycin|
15978854|NCT03045185|Procedure|RET using Ciprofloxacin 100mg, and Metronidazole 100mg.|"First Treatment Visit: Tooth isolation, access, pulp extirpation and root canal irrigation with 0.5% sodium hypochlorite. Canal negotiation, canal drying using paper points. Delivery of the Bi antibiotic paste (mixture of Bi antibiotic paste (Ciprofloxacin 100mg and Metronidazole 100mg with sterile water). Sealing tooth access with glass ionomer cement.
~Second Treatment Visit: Tooth analgesia using plain local analgesics, isolatation and re-access as described above. Irrigation of root canal system using normal saline followed by paper point dying. Initiation of bleeding through insertion of a sterile 23-gauge needle with a length of 2 mm beyond the working length into the periapical tissues. Access sealed using Portland cement, followed by glass ionomer and then composite resin."
15978855|NCT03045172|Biological|Platelet Rich Plasma|PRP
15978856|NCT03045172|Drug|Placebo|Saline
15978857|NCT03045159|Behavioral|Strong Families Strong Forces|Parenting program
15978858|NCT03045159|Behavioral|Strong Parents|self-care program
15978859|NCT03045146|Other|Multimodal brain imaging|Comparison of the Rate of Good Neurological Functional Outcome defined by Modified Rankin Scale 0-2, 3 Months after an acute ischemic stroke treated by thrombectomy according to the presence or not of a Target Mismatch on Baseline imaging (MRI or CTP).
15978860|NCT03045133|Drug|Methadone|Immediately after the induction of anesthesia, patients will receive intravenously methadone 0.1 mg/kg
15978861|NCT03045133|Drug|Morphine|Immediately after the induction of anesthesia, patients will receive intravenously morphine 0.1 mg/kg
15978862|NCT03045107|Procedure|Laparoscopic right colectomy with intracorporeal ileocolic anastomosis (IIA)|After complete right colon mobilization and ileocolic and right colic vessels ligation, the proximal transverse colon and the terminal ileum are transected with a laparoscopic EndoGIA TM stapler (Covidien Medtronic). The antimesenteric side of the stapled ends of the transverse colon and terminal ileum are approximated by a stay suture tied intracorporeally and then held by the assistant. An antimesenteric enterotomy and an antimesenteric colotomy are made about 10 cm distal to the stapled ends of the transverse colon and terminal ileum, respectively. A side-to-side anastomosis is fashioned with a laparoscopic EndoGIA TM stapler (Covidien Medtronic). The enterotomies are then closed by two layers of reabsorbable sutures tied intracorporeally. The specimen is delivered through a small Pfannenstiel or a median incision. A big dressing covering all incisions will be applied, similar to that used for the EIA group.
15978863|NCT03045107|Procedure|Laparoscopic right colectomy with extracorporeal ileocolic anastomosis (EIA)|After complete right colon mobilization and ileocolic and right colic vessels ligation, the terminal ileum, right colon, and proximal transverse colon are exteriorized for bowel division through a small midline skin incision in the upper abdomen. A primary ileocolic side-to-side handsewn or mechanical (with GIA stapler - Covidien Medtronic) anastomosis is fashioned and the bowel returned to the abdominal cavity. After reinduction of pneumoperitoneum, the lack of twists of the ileocolic anastomosis is checked. A big dressing covering all incisions will be applied.
15978864|NCT03045081|Behavioral|PainTracker Self-Manager|Interactive web-based educational and assessment program supported by a nurse care manager
15978865|NCT03045068|Biological|Platelet Transfusion|"Post CPB- Platelet transfusion 20ml/kg via a central venous line is continued at a rate of 100 ml/hour till completion.
~Initial transfusion to occur proximal to the hemofilter on the MUF circuit for as long as MUF lasts
~Subsequent platelet transfusion continued till completion via central venous access to the patient"
15978866|NCT03045068|Biological|FFP and Cryoprecipitate|"1 unit of cryoprecipitate administered during MUF and or after MUF as needed
~FFP transfusion 10ml/kg during MUF and or after MUF as needed"
15978867|NCT03045068|Biological|PRBC and cell saver Transfusion|1. Transfuse for target Hematocrit > 40 in neonates with SV physiology; Transfuse for Hematocrit> 33 for 2-Ventricle physiology
15978868|NCT03045068|Biological|Factor Concentrate (Bebulin)|1. Based on clinical bleeding and achievement of hemostasis
15978869|NCT03045055|Device|Remote ischemic conditioning.|The RIC procedure consists of four cycles of unilateral arm ischemia for 5 minutes, which was followed by reperfusion for another 5 minutes. The procedure is performed with an electric, autocontrol device with a cuff that inflated to a pressure of 200 mmHg during the ischemia period. RIC is performed before recanalization of the occluded artery, immediately following successful recanalization, and once daily for the subsequent 7 days.
15978870|NCT03045055|Procedure|Endovascular treatment.|Endovascular treatment of acute ischemic stroke is performed by experienced neuroradiologist according to the latest guideline from American Heart Association and American Stroke Association.It includes thrombectomy, intra-arterial thrombolysis, thrombus aspiration, stenting and balloon angioplasty.
15979024|NCT03043820|Drug|Raloxifene|Oral selective estrogen receptor modulator (SERM).
15978871|NCT03045055|Device|Sham remote ischemic conditioning|The sham RIC procedure consists of four cycles of unilateral arm ischemia for 5 minutes, which was followed by reperfusion for another 5 minutes. The procedure is performed with an electric, autocontrol device with a cuff that inflated to a pressure of 30 mmHg during the ischemia period. Sham RIC is performed before recanalization of the occluded artery, immediately following successful recanalization, and once daily for the subsequent 7 days.
15978872|NCT03045042|Drug|Enzyme Replacement Agent|Patients will be treated following the decision of their doctors. The investigators are going to analyze serum samples of these patients
15978873|NCT03045029|Drug|Oral treprostinil|Sustained-release oral tablets for TID administration
15978874|NCT03045016|Drug|Prazosin, ALPRESS® LP 2,5 et 5 mg|"Patients will take Prazosin during 28 days ; there are two periods of treatment (escalation of doses):
~PERIOD 1 (Day 0 - Day 7): 1 tablet of ALPRESS LP 2.5 mg (Prazosin) at bedtime for 7 days
~PERIOD 2 (Day 8 - Day 27): 1 morning tablet of ALPRESS LP 5 mg (Prazosin) at bedtime for 21 days."
15978875|NCT03045003|Behavioral|RESIL Intervention|Interventions tested in this study are the following: i) educational sessions with oncologists and nurses, ii) direct, electronic feed-back of resilience and needs screening in a monitoring sheet including intervention propositions and iii) consultation provided by a clinical nurse specialist to patients (in intervention B only) Interventions have been developed based on previous studies on the efficacy of screening of patient reported outcomes and direct feed-back to health care professionals and on previous studies on interventions to enhance resilience in nursing or psycho-oncology with proven efficacy. Interventions provided in the monitoring sheet have been validated by experienced Swiss oncology nurses, oncologists and psycho-oncologists.
15978876|NCT03044977|Drug|90Y-DOTA-3-Tyr-Octreotide|Peptide receptor radiotherapy (PRRT) using Yttrium-90 as the active radionuclide. For intravenous administration only.
15978877|NCT03044977|Drug|131I-MIBG|Peptide receptor radiotherapy (PRRT) using Iodine-131 as the active radionuclide. For intravenous administration only.
15978878|NCT03044964|Drug|Ranolazine|Patients will be started on 500mg twice daily and may be increased to 1000mg twice daily after 1 week. Patients will or may remain on the 1000mg for 5 weeks.
15978879|NCT03044964|Drug|Placebo|Patients will be started on 500mg twice daily and may be increased to 1000mg twice daily after 1 week. Patients will or may remain on the 1000mg for 5 weeks.
15978880|NCT03044951|Procedure|cryoballoon ablation|cryoballoon ablation：pulmonary vein isolation by cryoballoon
15978881|NCT03044951|Procedure|radiofrequency ablation|radiofrequency ablation: pulmonary vein isolation by radiofrequency energy
15978882|NCT03044938|Drug|salbutamol|Salbutamol or albuterol is a short-acting β2 adrenergic receptor agonist used for the relief of bronchospasm in conditions such as asthma and chronic obstructive pulmonary disease.
15978883|NCT03044938|Drug|Placebo|Neutral preparation for pharmacological effects, given in substitution of a medicine, for the purpose of provoking or controlling reactions, ger. Of a psychological nature, accompanying such a therapeutic procedure.
15978884|NCT03044925|Procedure|Remote magnetic navigation|Pulmonary vein isolation and other areas ablation guided by remote magnetic navigation
15978885|NCT03044925|Procedure|Cryoablation|Pulmonary vein isolation and other areas ablation used by cryoballoon
15978886|NCT03044912|Drug|mirabegron|To evaluate the efficacy and safety of Mirabegron 50 mg vs 25 mg in Taiwanese patients with overactive bladder syndrome
15978887|NCT03044899|Procedure|All surgeries in adult patients|All surgeries in adult patients
15978888|NCT03044886|Dietary Supplement|vitamin D|Subjects took vitamin D or placebo
15978889|NCT03044873|Drug|BMS-986165|Rosuvastatin on Day 1. BMS 986165 on Days 5-8 and Days 10-12. On Day 9, BMS 986165 coadministered with an oral dose of rosuvastatin.
15978890|NCT03044873|Drug|Rosuvastatin|Rosuvastatin on Day 1. BMS 986165 on Days 5-8 and Days 10-12. On Day 9, BMS 986165 coadministered with an oral dose of rosuvastatin.
15978891|NCT03044860|Procedure|Double-balloon enteroscopy (DBE) with biopsy retrieval|With the use of a double-balloon enteroscopy device, study participants underwent upper and lower enteroscopies with mucosal biopsy mucosal biopsy retrieval from every ~30 cm of the small intestine and specific locations in the large intestine
15978892|NCT03044847|Other|COPD group|The treatments will be determined by their treating physicians and no additional investigational drugs will be applied to the patients included in this study.
15978893|NCT03044834|Other|PPB|Global current care
15978894|NCT03044821|Procedure|Open-Uterus Fetal Repair|Single arm study. All patients will receive the open-uterus fetal repair.
15978895|NCT03044808|Drug|Lidocaine|
15978896|NCT03044808|Drug|Saline|
15978897|NCT03044795|Drug|Veliparib|Subjects in part A and part B will all start treatment with oral veliparib monotherapy twice a day. Patients will receive oral veliparib BID on days 1- 21, q3 weeks. All subjects will start with veliparib 300 mg, if the subject tolerates 300 mg BID for 2 weeks, veliparib may be increased to 400 mg BID at the investigator's discretion. Subjects will self-administer the morning dose and the evening dose of veliparib approximately 12 hours after the morning dose with or without food. ANC must be above 1.5 × 109/L in order to commence a new cycle.
15978898|NCT03044782|Other|53-Item Survey|
15978899|NCT03044769|Procedure|Malformations resection|Resection of the malformation lung sections with a healthy adjacent part
15978900|NCT03044756|Drug|Omit Citrotide 0.25 dose on the day of triggering of ovulation|Omit Citrotide 0.25 dose on the day of triggering of ovulation
15978901|NCT03044743|Drug|Fludarabine|To modify immune micro-environment
15978902|NCT03044743|Drug|Cyclophosphamide|To modify immune micro-environment
15978903|NCT03044743|Drug|Interleukin-2|To sustain the survival of infused T cells
15978904|NCT03044730|Drug|Capecitabine|Given PO
15978905|NCT03044730|Other|Laboratory Biomarker Analysis|Correlative studies
15978906|NCT03044730|Biological|Pembrolizumab|Given IV
15978907|NCT03044717|Other|Nutrition survey|Survey will be done prior to the initiation of the education
15978908|NCT03044717|Other|Educational Conference|A prevention educational conference will be available to attend once every 5 weeks.
15978909|NCT03044717|Other|3-hour nutrition module|Nutrition module will be provided by the Gaples Institute to participants as part of this study. This will be completed online via e-mail
15979025|NCT03043820|Drug|Placebo|Tablets identical in form and color to intervention.
15978911|NCT03044678|Behavioral|REACH for Success|Exposure-based cognitive behavioral with social skill training (cognitive self control, relaxation, skills for conversations and assertiveness)
15978912|NCT03044678|Behavioral|Self-Study|Books for youth about anxiety management
15978913|NCT03044665|Drug|Rosuvastatin|Subjects will start rosuvastatin 20 mg a day irrespective of previous lipid-lowering treatment or LDL-cholesterol level as current US guideline.
15978914|NCT03044665|Drug|Rosuvastatin plus ezetimibe|Subjects will start single combination pill of rosuvastatin 10 mg plus ezetimibe 10 mg a day irrespective of previous lipid-lowering treatment or LDL-cholesterol level.
15978915|NCT03044652|Device|WO2085 Moisturising Cream|2.5 g of the investigational product WO2085 Moisturising Cream will be applied intravaginally, once daily in the evening. After improvement of the symptoms the frequency may be reduced by the patient as needed. In addition 0.5 g (1 fingertip unit) may be applied to the outer genital area as needed (also several times per day).
15978916|NCT03044652|Drug|Estriol Cream 0.1%|0.5 g of the reference product Estriol Cream 0.1% will be applied intravaginally once daily in the evening for the first 3 weeks. Subsequently, the frequency will be reduced to twice a week for the last 3 weeks for all patients in this treatment group.
15978917|NCT03044639|Drug|Lipid Emulsions, Intravenous|The every day provision of lipid emulsion as a part of parenteral nutrition along with dextrose, amino acids, electrolytes, trace elements, vitamins and water in the dose of 0.8-1.0 g/kg/day.
15978918|NCT03044626|Drug|Radiotherapy|"Nivolumab 240 mg fixed dose (q2w). First dose followed by radiotherapy. Radiotherapy has to start at the latest 72 hours after nivolumab administration.
~Radiotherapy: A metastatic site will be treated with a radiation dose of 4 Gy for a total of 5 courses during a two week time interval (total dose 20 Gy)"
15978919|NCT03044626|Drug|Nivolumab|Nivolumab 240 mg fixed dose (q2w)
15978920|NCT03044613|Drug|Nivolumab|240mg or 1 mg/kg administered IV
15978921|NCT03044613|Drug|Relatlimab|80mg administered IV
15978922|NCT03044613|Drug|Carboplatin|standard care dose
15978923|NCT03044613|Drug|Paclitaxel|standard care dose
15978924|NCT03044613|Radiation|Radiation|standard care dose
15978925|NCT03044600|Other|Chart Review|Patient charts will be reviewed to collect demographic data, pre-operative and post-operative clinical and laboratory data, operative reports, and pathology reports.
15978926|NCT03044600|Other|HRPT2 Mutation Evaluation|Archived formalin-fixed paraffin-embedded (FFPE) tissue blocks from surgical specimens of patients stained for parafibromin to evaluate for HRPT2 mutations.
15978927|NCT03044587|Drug|Arm NaI-IRI + 5-FU + Leucovorin (Arm A)|Nal-IRI (80 mg/m2 as a 1.5 hour infusion), 5-FU (2400 mg/m2 as 46 hour infusion) and Leucovorin (400 mg/m2 as 0.5 hour infusion) Cycle q2w
15978928|NCT03044587|Drug|Arm Cisplatin + Gemcitabine (Arm B)|Cisplatin (25 mg/m2 as 1 hour infusion on D1, D8) and Gemcitabine (1000 mg/m2 as 0.5 hour infusion on D1, D8) Cycle q3w
15978929|NCT03044574|Device|SCD|Intermittent pneumatic compression (IPC) with Kendall SCD™ Sequential Compression System 700 used continuously when the patient is in bed with 6-hours night interval free of compression: from 0 a.m. to 6 a.m. In the ICU SCD used continuously all day, and in surgery department - all time of bed resting. SCD used until discharge.
15978930|NCT03044574|Device|GCS|Thigh-length graduated compression stockings with pressure of 18-21 mm. Hg at the ankle used all the time until discharge plus one month after discharge
15978931|NCT03044574|Drug|LMWH|LMWH enoxaparin (Clexane) 40 mg once a day subcutaneously started on 1st or 2-5th postoperative day according to the bleeding risk and used until discharge.
15978932|NCT03044561|Drug|Sildenafil Citrate|25 mg orally, 4 times per day for 21 days
15978933|NCT03044561|Drug|matching placebo|orally, 4 times per day for 21 days
15978934|NCT03044548|Other|Supportive supervision|" Supportive supervision. The specific characteristics of the supportive supervision as intended in this project are outlined below.
~Frequency: Biweekly in the first 3-5 months, than monthly. Duration: approximately 2 hours in each HC at each visit. Provider: local staff (nutritionist, DHO) trained in integrated management acute malnutrition (IMAM) guidelines and in methods of  supportive supervision.
~Receivers: nurses working at HC level with children with malnutrition.
~Reference guidelines:
~• Current National IMAM guidelines
~Attitude and philosophy:
~• Participatory peer-to-peer model based on the Plan - Do- Study- Act quality improvement (QI) Cycle ."
15978935|NCT03044522|Other|Opioid Education|
15978936|NCT03044509|Diagnostic Test|Secreted cytokine assay|Blood collected in a sodium-heparin tube will be used for the assay using novel TB-specific antigens. After incubation the supernatant will be harvested and cryopreserved at -80 °C for further testing of cytokines. Cytokines will be measured using a bead-based multiplex assay reader (MAGPIX, Luminex Crop., Austin, USA).
15978937|NCT03044509|Diagnostic Test|Intracellular cytokine assay|Blood will be stimulated with recombinant MTB-specific antigens, ESAT-6, CFP-10, positive control or left unstimulated. Following an initial duration of stimulation, Brefeldin-A will be added and the blood incubated for a further 5 hours. White cells will be fixed and cryopreserved at - 80°. Batched analysis within 6 months of cryopreservation will be done using multi-colour flow cytometry.
15978938|NCT03044496|Drug|Supraclavicular nerve block|Supraclavicular nerve block using ultrasound and 10ml ropivacaine 0.5% with 20ml mepivacaine 1%
15978939|NCT03044483|Other|Measurement of sublingual microcirculatory parameters|Measurement of the sublingual microcirculatory function using the CytoCam-IDF imaging device to establish the normal range for each age group noted.
15978940|NCT03044470|Other|cryotherapy|Role of cryotherapy in reduction of post operative pain
15978941|NCT03044457|Procedure|TKA|"femoral and tibial positioning using the reversed gap technique"
15978942|NCT03044444|Dietary Supplement|citrus extract|Participants will receive either a low or high dose citrus extract
15978943|NCT03044444|Other|placebo|participants will receive 500mg of maltodextrin
15978944|NCT03044431|Procedure|Cell therapy|Each participant will receive cell therapy with stem cells harvested either from peripheral blood or from bone marrow plus peripheral blood; after harvest, cells are processed and returned to the patient via peripheral circulation on the same day.
15978945|NCT03044418|Other|Application of ET laser tube in propofol anesthesia|The special ET laser tube covered by aluminum tape is used during anesthesia of endolaryngeal laser surgery.
15978946|NCT03044405|Diagnostic Test|Fluid challenge|Fluid bolus of 500 ml of crystalloids is given over 15 minutes. Positive fluid responsiveness is defined by an increase in SV of at least 15%.
15978947|NCT03044405|Diagnostic Test|Focused transthoracic echocardiography|Focused transthoracic echocardiography is performed to assess expansion of stroke volume after fluid challenge. Also mitral E and A waves, left ventricle outflow tract velocity time integral (LVOT VTI) and its variability, inferior vena cava diameters during breathing cycles are measured.
15978948|NCT03044392|Other|Next Bolus Interval|Next Bolus Interval 15, 30, or 45 minutes
15978949|NCT03044379|Drug|Dapivirine gel (0.05%)|MTN-026/IPM 038 will use the HTI pre-filled applicator, the same applicator that has been utilized in other rectal studies.
15978950|NCT03044379|Other|Universal HEC placebo gel|
15978951|NCT03044366|Other|general anesthesia management of preterm infants|general anesthesia management of preterm infants
15978952|NCT03044353|Drug|GSK2315698 (CPHPC)|20mg/hour, IV (in the vein) for up to 72hours followed by 60mg three times daily subcutaneous injection for 11 days. Number of cycles: up to 6. Dose level and frequency adjusted according to renal function
15978953|NCT03044353|Biological|GSK2398852 (anti-SAP mAb)|Up to 1200mg, IV divided over days 1 and 3. Number of cycles: up to 6. Dose level adjusted based on tolerability.
15978954|NCT03044340|Other|impedance measurement and pain evaluation|Measurement of chlorine ions impedance by SUDOSCAN and pain due to temperature evaluation with THERMOTEST
15978955|NCT03044327|Procedure|LPS challenge|LPS inhalation and bronchial instillation
15978956|NCT03044314|Drug|Illoprost and nitric oxide administration|Iloprost will be administered by the I-neb ultrasonic nebulizer (Respironics, Cedar Grove, New Jersey) with a disposable attachment that allows for administration to a supine patient at a concentration of 10 µg/ml with a 10 minute dose of 2.5 µg and then repeated to a cumulative dose of 5.0 µg if tolerated.
15978957|NCT03044301|Combination Product|Intramuscular ZENEO® injection|Sodium Chloride (0.9 %)
15978958|NCT03044301|Combination Product|Subcutaneous high ZENEO® injection|Sodium Chloride (0.9 %)
15978959|NCT03044301|Combination Product|Subcutaneous low ZENEO® injection|Sodium Chloride (0.9 %)
15978960|NCT03044288|Other|New adhesive strip|This is a strip made of a newly developed adhesive. This adhesive might in the future be part of an ostomy product.
15978961|NCT03044288|Other|Standard adhesive strip|this is a standard adhesive strip (hydrocolloid). This adhesive is currently used in marketed ostomy devices.
15978962|NCT03044275|Other|New adhesive strip|This is a newly developed adhesive strip that in the future might be part of an ostomy device
15978963|NCT03044275|Other|Standard adhesive strip|This is a standard adhesive strip (hydrocolloid). The adhesive is a part of an ostomy device
15978964|NCT03044262|Other|Standard adhesive strip|This is a standard adhesive strip (hydrocolloid) that is part of an ostomy device
15978965|NCT03044262|Other|New adhesive strip|This is a newly developed adhesive strip that in the future might be part of an ostomy device
15978966|NCT03044249|Drug|MP-101|Capsules
15978967|NCT03044249|Drug|Placebo|Capsules
15978968|NCT03044236|Procedure|Stretching|The novel stretching technique will be done on a supine position. subjects will be asked bridge as high as possible. After That, Participants will then flex their shoulder and elbow to 90°. Participants will use the other hand to push to the point of mild discomfort and simultaneously maintain contraction while progressing the stretch.
15978969|NCT03044210|Other|Metabolic evaluation|"diet assessment
~biological evaluation
~clinical evaluation
~metabolic evaluation (calorimetry)"
15978970|NCT03044197|Device|MRI/ultrasound transperineal prostate biopsy|3-6 targeted biopsy cores from each prostate region of interest
15978971|NCT03044197|Device|transrectal ultrasound-guided prostate biopsy|12 systematic biopsy cores
15978972|NCT03044184|Drug|Tranexamic Acid|Transamine is an antifibrinolytic medication given systemically via the intravenous route
15978973|NCT03044171|Device|Low Level Laser Therapy|Laser therapy: it was used the infrared spectrum with wavelength of 808 nm in its active environment AsGaAl, in two points: cervical and central-medial region of the incisors, canines and premolars.
15978974|NCT03044171|Drug|1.1% Sodium Fluoride|Fluoride therapy: 1.1% sodium fluoride 5000 ppm was applied for 5 minutes on the vestibular surface of all pre-bleached dental elements.
15978975|NCT03044171|Drug|In-office dental bleaching|Both groups received the in-office bleaching treatment. Three 15-minute applications of the 35% hydrogen peroxide gel were performed, totaling 45 minutes in each of the 4 sessions, with a 7-day interval.
15978976|NCT03044158|Device|GeneXpert I|Onsite molecular testing with GeneXpert I as a replacement for microscopy
15978977|NCT03044158|Behavioral|Process re-design|Research and Uganda NTLP staff will engage health center staff in a discussion of how to re-organize clinical, laboratory and pharmacy services to enable same-day TB diagnosis and treatment.
15978978|NCT03044158|Other|Performance Feedback|Feedback of TB diagnostic evaluation quality indicators to health center staff
15978979|NCT03044145|Behavioral|The Cultural Formulation Interview-Engagement Aid|Culture affects how all people communicate and understand the world. Culture is important because patients and clinicians from different cultural backgrounds may have different preferences for communication. Mismatch in the clinician's approach and the patient's expectations of care can lead to patient dissatisfaction and discontinuation with treatment. Patients and clinicians may also have different views about what caused an illness, how it functions, what makes it better or worse, and the types of treatment needed. The CFI-EA is a series of questions over three sessions that clinicians can use to clarify patient views about treatment and communication so that patients stay in treatment longer. Clinicians can use the CFI-EA to customize their current treatment plans.
15978980|NCT03044145|Behavioral|The Cultural Formulation Interview-Engagement Aid (Revised)|The study team will revise the CFI-EA based on patient and clinician feedback. The study team expects that the revisions will consist of changes to the questions such as adding or subtracting specific items or revising the wording of the content. The study team do not anticipate other changes, though we will let our empirical data analyses guide revisions in consultation with the K23 mentor team.
15978981|NCT03044145|Behavioral|Treatment as usual|Standard mental health treatment at FHMC
15978982|NCT03044132|Other|DermACELL AWM|Decellularized regenerative human tissue matrix allograft (dermis) processed using proprietary Matracell® technology
15978983|NCT03044119|Biological|Dental Implant with PRFM|placement of a minimum of two adjacent dental implants being randomly assigned into (G1) - Dental implant with PRFM
15979026|NCT03043807|Drug|Leuprolide Acetate|22.5mg by intramuscular (IM) injection every 3 months
15978984|NCT03044119|Biological|Dental Implant with PRFM and PBMSCs|placement of a minimum of two adjacent dental implants being randomly assigned into (G2) - Dental implant with peripheral blood mesenchymal stem cells embedded in PRFM.
15978985|NCT03044106|Device|CLRT|CLRT is a novel method of laser stimulation on specific cranial reflex points that modulate muscle tone.
15978986|NCT03044093|Drug|Mifepristone|The group that will get in addition to Misoprostol also Mifepristone
15978987|NCT03044093|Drug|Placebo|The group that will only get Misoprostol
15978988|NCT03044093|Drug|Misoprostol|Both groups will get think drug
15978989|NCT03044080|Drug|IncobotulinumtoxinA|Three consecutive injections of 200-300 units of IncobotulinumtoxinA (Xeomin ®) under ultrasound guidance. The IncobotulinumtoxinA will be distributed according to the individual clinical pattern of spasticity: plantar flexor muscles (triceps sural: gastrocnemius and soleus), tibialis posterior, flexor digitorum longus.
15978990|NCT03044080|Drug|OnabotulinumtoxinA|ree consecutive injections of 200-300 units of OnabotulinumtoxinA (Botox ®) under ultrasound guidance. The BoNT/A will be distributed according to the individual clinical pattern of spasticity: plantar flexor muscles (triceps sural: gastrocnemius and soleus), tibialis posterior, flexor digitorum longus.
15978991|NCT03044067|Other|Pain neuroscience education + Exercise|A session of Pain neuroscience education + Exercise covers the activity, strength and endurance of lower and upper muscles of the extremities. Besides that it will be covered the understanding and acknowledgement about how pain is processed.
15978992|NCT03044067|Other|Exercise|A session of exercise covers the activity, strength and endurance of lower and upper muscles of the extremities.
15978993|NCT03044054|Device|ECHOPULSE|HIFU Under ultrasound guidance
15978994|NCT03044041|Drug|Tranexamic Acid|IA (intra-articular) tranexamic acid after capsule closure
15978995|NCT03044028|Device|CyMedica Orthopedics QB1 e-vive™ system|a multifunctional electrotherapy device providing neuromuscular electrical stimulation (NMES), for improving quadriceps strength and improving functional outcomes accelerating functional recovery in patients managed with total knee arthroplasty (TKA).
15978996|NCT03044015|Behavioral|community based integrated strategy for secondary prevention of OF|Educational programme on pharmacological treatment, diet recommendations, physical activity programme on OF prevention in primary care
15978997|NCT03044015|Behavioral|as usual|
15978998|NCT03044002|Device|Biotronik 4 French Portfolio|Ambulatory intervention by femoral access for endovascular treatment of lower-extremity peripheral artery disease
15978999|NCT03044002|Device|6 French Portfolio|Ambulatory intervention by femoral access for endovascular treatment of lower-extremity peripheral artery disease
15979000|NCT03043989|Drug|Docetaxel|6 infusions of Docetaxel with 18 doses clarithromycin
15979001|NCT03043989|Drug|Cabazitaxel|6 infusions of Cabazitaxel with 18 doses clarithromycin
15979002|NCT03043989|Drug|Clarithromycin|18 doses of clarithromycin with either Docetaxel or Cabazitaxel
15979003|NCT03043976|Device|Actigraph GT9X Link device|"Assessment of the level of physical activity of PH patients using the Actigraph GT9X Link device that includes a triaxial accelerometer and can be enabled to show on its display the number of steps taken for the day, so that it can also be used by the patients as a common pedometer.
~Evaluation of the effects of an 8 week step count-based light touch training programme to see if activity can be increased"
15979004|NCT03043963|Behavioral|Sleep Extension|Lengthen the duration of sleep time.
15979005|NCT03043963|Behavioral|Sleep Timing|Regularize the timing of the sleep period.
15979006|NCT03043950|Drug|Panitumumab|Patients will be scheduled to receive first line therapy with the combination of Panitumumab (6 mg / kg i.v, given once every two weeks) and FOLFIRI or FOLFOX, according to current SmPC.
15979007|NCT03043937|Other|registry|
15979008|NCT03043924|Drug|Cyproterone Acetate + estradiol|"PCOS will receive:
~50mg cyproterone acetate (Androcur®) in combination with p.o. 2mg estradiol daily"
15979009|NCT03043924|Drug|Levonorgestrel, Ethinyl Estradiol 0.1-0.02Mg Oral Tablet|Healthy volunteers receive combined oral contraceptive (COC) consisting 0.02 mg ethinylestradiol and 0.1mg of progestins (Leeloo Gé®)
15979010|NCT03043898|Other|Lung sound transmission measurement|Sound at chest wall is recorded using a sensor array during the bronchoscopy procedure, while a sound is played down the working channel of the bronchoscope.
15979011|NCT03043898|Other|Lung sound recording|Lung sounds are recorded using a sensor array.
15979012|NCT03043885|Device|FDBA|Graft material used to graft extraction socket
15979013|NCT03043885|Device|PRF|Autologous blood product used to graft extraction socket
15979014|NCT03043885|Procedure|Blood Clot|Surgical treatment of extraction socket without addition of graft material
15979015|NCT03043872|Drug|Durvalumab|IV infusions every 3 weeks for 12 weeks (4 cycles) and every 4 weeks thereafter until PD or other discontinuation criteria.
15979016|NCT03043872|Drug|Tremelimumab|IV infusions every 3 weeks for 12 weeks(4 cycles). An additional dose of tremelimumab will be administered in the week 16.
15979017|NCT03043872|Drug|Carboplatin|up to 4 cycles every 3 weeks in Arm 1 and 2, up to 6 cycles every 3 weeks in Arm 3
15979018|NCT03043872|Drug|Cisplatin|up to 4 cycles every 3 weeks in Arm 1 and 2, up to 6 cycles every 3 weeks in Arm 3
15979019|NCT03043872|Drug|Etoposide|up to 4 cycles every 3 weeks in Arm 1 and 2, up to 6 cycles every 3 weeks in Arm 3
15979020|NCT03043859|Behavioral|Pure Prairie Living Program|Education session (n=5) on healthy eating, menu planning and skill building for effective diabetes management
15979021|NCT03043846|Other|Follow-up every 3 months during 1 year (data collection in eCRF)|
15979022|NCT03043846|Other|Follow-up every month to follow the pre-defined strategy|
15979023|NCT03043833|Behavioral|The Wellbeing Course|"The Wellbeing Course (Titov et al., 2011) includes five online lessons:
~Lesson 1 presents information on the prevalence of anxiety disorders and depression as well as on how they may interfere with life goals. This lesson also discusses how cognitive, behavioral and physical symptoms can contribute to poor emotional health.
~Lesson 2 presents different strategies to generate realistic cognitions.
~Lesson 3 describes strategies for physical de-arousal and for re-engaging in reinforcing activities.
~Lesson 4 describes avoidance and safety behaviors in relation with anxiety and depression along with graded exposure.
~Lesson 5 is about problem solving, relapse prevention and staying well.
~For each lesson, a Do It Yourself guide is included as well vignettes and additional material."
15979027|NCT03043807|Drug|Docetaxel|75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles. Dose may decreased in the following intervals: 65 mg/M2, 55 mg/M2, 35 mg/M2.
15979028|NCT03043807|Drug|Bicalutamide|bicalutamide (Casodex) 50mg by mouth daily
15979029|NCT03043807|Radiation|Radiation|Radiation will be delivered in 1 to 5 fractions, and the dose and fractionation schedule will depend on the size and location of the lesion and the surrounding normal tissue constraints in accordance with AAPM Task Group 101 recommendations. Typical doses include 16 - 24 Gy in 1 fraction, 48 - 50 Gy in 4 fractions, and 50 - 60 Gy in 5 fractions.
15979030|NCT03043807|Drug|Abiraterone Acetate|Abiraterone acetate 1000 mg / day may be given at the investigator's discretion.
15979031|NCT03043794|Radiation|Stereotactic Body Radiation SBRT|Stereotactic Body Radiation to the breast to 21 Gy
15979032|NCT03043781|Other|Continuous epidural infusion|Continuous infusion, 5 ml/h
15979033|NCT03043781|Other|Intermittent epidural bolus|Intermittent bolus 5 ml every hour
15979034|NCT03043742|Drug|Bone Marrow Derived Autologous CD133+ Selected Cell Product|Injection of bone marrow derived autologous CD133+ cell product into laser channels during Trans-Myocardial Revascularization
15979035|NCT03043729|Drug|Oxaliplatin|Oxaliplatin 85 mg/m^2, as 2h infusion on Day 1 (Arm A + Arm B)
15979036|NCT03043729|Drug|5-FU|5-FU 400 mg/m^2 i.v. as bolus on Day 1 and 2400 mg/m^2 as 46 h infusion q2w (Arm A + Arm B)
15979037|NCT03043729|Drug|Leucovorin|Leucovorin 350 mg/m^2 i.v. as 2h infusion on Day 1 (Arm A + Arm B)
15979038|NCT03043729|Biological|Aflibercept|Aflibercept 4 mg/kg BW i.v. on Day 1 q2w (Arm B, Cycles 1 to 5)
15979039|NCT03043716|Other|PAP therapy with telemonitoring|Patients will receive a prescription for PAP therapy in the course of their clinical Routine pathway and afterwards be asked to enrol in the registry. The will be asked if they are willing to use telemonitoring technology.
15979040|NCT03043703|Device|AirSense 10 AutoSet for Her|Positive airway pressure
15979041|NCT03043690|Dietary Supplement|Ammonium succinate|2 capsules of ammonium succinate-based dietary supplement (one white, 200 mg, and one orange, 200 mg), once a day, in the morning with a meal, for 90 days.
15979042|NCT03043690|Other|Placebo|2 capsules of ammonium succinate-based dietary supplement (one white, 200 mg, and one orange, 200 mg), once a day, in the morning with a meal, for 90 days.
15979043|NCT03043677|Biological|Ex-vivo stimulation of cells with infliximab, golimumab, adalimumab, vedolizumab and ustekinumab|"Ex-vivo conditioning of lamina propria and peripheral blood mononuclear cells.
~Here, we will address whether the current available biological therapies for IBD patients (infliximab, golimumab, adalimumab, vedolizumab and ustekinumab) elicit a differential effect on the mucosal capacity to recruit circulating leukocytes on an ex-vivo approach using transwell culture systems."
15979044|NCT03043664|Drug|Somatuline Depot|Somatuline depot (Lanreotide depot) 90mg SQ every 3 weeks
15979045|NCT03043664|Drug|Keytruda|Keytruda (pembrolizumab) 200mg IV every 3 weeks
15979046|NCT03043651|Drug|Oral treprostinil|Sustained-release oral tablets for TID administration
15979047|NCT03043638|Procedure|CAF+ADM+PRP|CAF+ADM+PRP group treated with coronally advanced flap technique including ADM placement, In CAF+ADM+PRP group, ADM was hydrated in the platelet-poor plasma (PPP) and the PRP was applied to surgical sites prior to final suturing.
15979048|NCT03043638|Procedure|CAF+ADM|CAF+ADM group treated with coronally advanced flap technique including ADM placement without PRP application
15979049|NCT03043625|Other|Visceral manipulation|Participants will be instructed to lie down comfortably on a stretcher in the supine position, with lower limbs flexed and abdomen exposed, and the physiotherapist positioned to the right side of the patient. The therapeutic intervention will be began with the left hand of the physiotherapist in contact with the lower region of the stomach, to which a force will be applied so that the organ was moved in an upper and lateral left direction while the right hand controlled and directed the knees of the patient to the right side until the moment when the physiotherapist notice an increase in tension in the stomach region. For the liver manipulation, the same procedures will be followed, however, with contact in the right epigastric region and the knees directed to the left side. The same position will be maintained for each organ treated until the physiotherapist could feel, through touch, a decrease in the tension of the viscera. The mean treatment time will 5 minutes.
15979050|NCT03043625|Other|Control group (CG)|The CG will be received placebo treatment. In the placebo treatment, the therapist should place the hands over the navel region without exerting any local tension for 1 minute.
15979051|NCT03043612|Device|Cook Sof-Flex® Double Pigtail Ureteral Stent coextruded with doxazosin|Placement of drug-coated ureteral stent when temporary ureteral stenting is indicated following ureteroscopy for urolithiasis
15979052|NCT03043612|Device|Cook Sof-Flex® Double Pigtail Ureteral Stent|Placement of a commercially available ureteral stent when temporary ureteral stenting is indicated following ureteroscopy for urolithiasis
15979053|NCT03043599|Radiation|Thoracic Radiation Therapy|All participants will receive radiation therapy (3Gy x 10 fractions) to the chest for 10 days (Monday through Friday for 2 weeks).
15979054|NCT03043599|Drug|Ipilimumab|Ipilimumab 3 mg/kg (90 minute IV infusion) will be administered every 3 weeks for 4 doses.
15979055|NCT03043599|Drug|Nivolumab|Nivolumab 1 mg/kg (30 minute IV infusion) will be administered every 3 weeks for 4 doses, followed by nivolumab 480 mg every 4 weeks.
15979056|NCT03043573|Behavioral|PATH-MCI|Problem Adaptation Therapy for Mild Cognitively Impaired Adults (PATH-MCI) differs from standard of care psychotherapy by offering a combination of emotion regulation techniques with the provision of environmental adaptation tools (notes, checklists, calendars, etc.), the use of the WellPATH app, and the participation of a willing and available caregiver.
15979057|NCT03043573|Behavioral|Supportive Therapy|ST focuses on: 1. facilitating expression of affect; 2. conveying to the patient that he or she is understood; 3. offering empathy; and 4. highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors.
15979058|NCT03043560|Drug|Ezogabine|daily for 5 weeks
15979059|NCT03043560|Drug|Placebos|placebo pill daily for 5 weeks
15979060|NCT03043547|Drug|nal-IRI|nal-IRI [Irinotecan liposome] (80 mg/m2 as a 1.5 hour infusion)
15979061|NCT03043547|Drug|5-FU|5-FU [5-Fluorouracil] (2400 mg/m2 as 46 hour infusion)
15979062|NCT03043547|Drug|leucovorin|leucovorin (400 mg/m2 as 0.5 hour infusion)
15979102|NCT03043365|Drug|control fish oil|4 capsules, 3 times a day after meals
15979063|NCT03043534|Other|shave gel|"Non marketed pre-shave gel with the following INCI list of ingredients:
~WATER, GLYCERIN, DIMETHICONE, LAURETH-23, PETROLATUM, ACRYLAMIDE/SODIUM ACRYLOYLDIMETHYLTAURATE COPOLYMER, ISOPROPYL PALMITATE, HYDROXYETHYLCELLULOSE, FRAGRANCE, PEG-23M, C13-14 ISOPARAFFIN, DMDM HYDANTOIN, DISODIUM EDTA, LAURETH-7, IODOPROPYNYL BUTYLCARBAMATE"
15979064|NCT03043534|Other|Brush|All subjects randomized to brush will use the brush with each shave
15979065|NCT03043521|Drug|Dexlansoprazole 60 MG|
15979066|NCT03043521|Drug|CJ-12420 50mg|
15979067|NCT03043521|Drug|CJ-12420 100mg|
15979068|NCT03043521|Drug|CJ-12420 200mg|
15979069|NCT03043508|Other|Chart Review|Database reviewed to obtain patient and disease characteristics, laboratory values, imaging results, hormone parameters (menopausal status, bioidentical hormone use, oral contraception use, gestational status and diagnosis of a prolactinoma) and vital status.
15979070|NCT03043508|Behavioral|Questionnaire|Participants sent an email questionnaire to complete regarding their pregnancy and hormone use history.
15979071|NCT03043495|Procedure|Ultrasound guided supraclavicular brachial plexus block|ultrasound guided Supraclavicular brachial plexus block
15979072|NCT03043495|Drug|Dexamethasone|Various doses of Dexamethasone (2, 4 & 8 mg) to be used as an Adjuvant to Local anesthetic drugs
15979073|NCT03043482|Drug|Single VS-105/placebo to healthy|In Part 1, single ascending doses of VS-105 or placebo will be administered to approximately 5 cohorts of 8 healthy subjects in each cohort with 6 receiving active and 2 receiving placebo.
15979074|NCT03043482|Drug|Multiple VS-105/placebo to healthy|In Part 2, multiple ascending doses of VS 105 or placebo will be administered each morning over 7 consecutive days to approximately 3 cohorts of 8 healthy subjects in each cohort with 6 receiving active and 2 receiving placebo..
15979075|NCT03043482|Drug|Multiple VS-105/placebo to HD subjects|In Part 3, multiple ascending doses of VS 105 will be administered over 14 consecutive days to approximately 3 cohorts that will each include 4 hemodialysis subjects with 3 receiving active drug and 1 receiving placebo.
15979076|NCT03043469|Other|Short-form survey instrument|Questionnaire with questions about quality of life. Takes about 5 minutes to be completed.
15979077|NCT03043469|Other|Demographic data|height, weight, age, gender, list of comorbidities, health history, level of physical activity, medicines in use. Takes about 10 minutes to be completed.
15979078|NCT03043469|Other|Hospital Anxiety and Depression Scale|Questionnaire with questions about anxiety and depression. Takes about 5 minutes to be completed.
15979079|NCT03043469|Other|Nijmegen questionnaire|Answering questions about symptoms related to breathing. Takes about 5 minutes to be completed.
15979080|NCT03043469|Other|The Self-evaluation of breathing questionnaire|Answering questions about self-evaluation of breathing. Takes about 5 minutes to be completed
15979081|NCT03043469|Other|six-minute exercise test|Cycling against certain load in a bicycle for 6 minutes. Takes about 16 minutes to be completed together with indirect calorimetry, oxygen saturation monitoring, heart rate variability analysis and continuous monitoring of arterial blood pressure).
15979082|NCT03043469|Other|Indirect calorimetry|Breathing through a mask that measures levels of oxygen, carbon dioxide, breathing frequency and others (non-invasively). Takes about 16 minutes to be completed, together with the 6-minute exercise test.
15979083|NCT03043469|Other|Oxygen saturation monitoring|The measurement of the amount of oxygen which is attached to haemoglobin molecules (non-invasively). Takes about 16 minutes to be completed, together with the 6-minute exercise test.
15979084|NCT03043469|Other|Heart rate variability analysis|Measurement of the variation in the beat-to-beat interval (non-invasively). Takes about 16 minutes to be completed, together with the 6-minute exercise test.
15979085|NCT03043469|Other|Continuous measurement of arterial blood pressure|Measurement of blood pressure based on the peripheral pulse using a finger cuff (non-invasively). Takes about 16 minutes to be completed, together with the 6-minute exercise test.
15979086|NCT03043469|Diagnostic Test|Lung function test|Breathing through a mouth-piece in many different ways in order to measure the function of the lungs (non-invasively).
15979087|NCT03043469|Other|Respiratory muscle function|Breathing through a mouth-piece in many different ways in order to measure the function of the respiratory muscles (non-invasively).
15979088|NCT03043469|Other|Manual assessment of respiratory motion|Measure of the movements of the thorax while the participant is breathing (non-invasively).
15979089|NCT03043469|Other|Breath-hold test|Holding the breath a few times for as long as possible.
15979090|NCT03043469|Other|Physical Activity monitoring|Wearing a light-weight activity monitor to be wore on the hip for 7 consecutive days during, at least, 8 hours per day.
15979091|NCT03043469|Other|Asthma Control Questionnaire|Only for asthmatics: answering questions about the control the participant has over this respiratory condition/symptoms.
15979092|NCT03043456|Device|Thermoplastic complete denture|A device used to substitute the teeth for edentulous patients made of thermoplastic resin
15979093|NCT03043456|Device|Conventional acrylic resin complete denture|A device used to substitute the teeth for edentulous patients made of acrylic resin
15979094|NCT03043443|Drug|Melatonin|Natural health product for sleep problems treatment
15979095|NCT03043443|Drug|Placebo|Lactose containing pills
15979096|NCT03043430|Drug|Ketamine 100 MG/ML|Administer ketamine via mucosal atomization device
15979097|NCT03043430|Drug|Midazolam 5 MG/ML|Administer midazolam via mucosal atomization device
15979098|NCT03043417|Behavioral|CHC's given the intervention|CHC's NOT given the intervention
15979099|NCT03043404|Device|Transcatheter aortic valve replacement|TAVR with Lotus Valve Flex System
15979100|NCT03043391|Biological|Polio/Rhinovirus Recombinant (PVSRIPO)|PVSRIPO will be delivered intratumorally by convection-enhanced delivery (CED) using an intracerebral catheter placed within the enhancing portion of the tumor. A stereotactic biopsy will be performed prior to virus administration. Immediately following the stereotactically-guided tumor biopsy, a catheter will be implanted in the operating room at a site the same or different from that used for the biopsy using sterile techniques under general anesthesia. The entire volume of PVSRIPO to be delivered will be pre-loaded into a syringe by the investigational pharmacist and connected to the catheter under sterile conditions in the Pediatric Intensive Care Unit (PICU) just prior to beginning of infusion.
15979101|NCT03043378|Behavioral|Questionnaires|Participants complete three questionnaires at consultation visit.
15979104|NCT03043352|Dietary Supplement|Management of SAM at home|LHWs will identify and treat all cases of severe acute malnutrition (SAM) in children under-five years at household level compared with the standard CMAM program
15979105|NCT03043352|Dietary Supplement|Management of SAM at facility|LHWs will identify SAM as per 'Standard CMAM program' (MUAC < 11.5cm) and will refer all cases to the health facility BHU/ satellite site (ACF) for further management and counselling by health workers (ACF CMAM Nurse) at facility level.
15979106|NCT03043339|Other|Stool Specimen Collection|Participants will provide a stool sample at baseline (pre-operation) and 30 days after the transplant operation. Stool specimens will be self-collected by the participant.
15979107|NCT03043339|Other|Anal Swab Sampling|Anal swabs will be collected prior to surgery (baseline) and at post-operation days 2, 15, and 30. Participants whose planned hospitalization duration is extended from the pre-surgical plan will have an additional, optional, anal swab collected 2 days prior to their anticipated hospital discharge date. Anal swabs will be collected by the study team, except for the standard of care post-operative appointment (30 days after the operation) for the living donors who will collect their own samples.
15979108|NCT03043339|Other|Short Diet Assessment (SDA)|The study coordinator will administer the Short Diet Assessment (SDA) to participants prior to surgery at baseline and post-operation days 2, 15, and 30. Participants whose planned hospital length of stay is extended from the pre-surgical plan will complete the questionnaire 2 days prior to their anticipated hospital discharge date.
15979109|NCT03043339|Other|NHANES Dietary Screener Questionnaire (DSQ)|The National Health and Nutrition Examination Survey (NHANES) 2009-2010 Dietary Screener Questionnaire will be completed on Post-Operative Day 2. The questionnaire asks about foods consumed during the past 30 days. There are 25 items on the questionnaire and additional questions may be asked depending on responses provided. The questionnaire will be self-administered or administered by a study team member.
15979110|NCT03043326|Drug|Tenofovir Disoproxil Fumarate and Emtricitabine|This is an observational study. Pre-exposure Prophylaxis with TDF/3TC will be distributed to all participants elegible to receive PrEP.
15979113|NCT03043300|Other|Screening Criteria Review|"The screening criteria review is an 8 item instrument collecting information during screening about overall health, including self-reported chronic intestinal conditions, immunocompromising conditions, the use of certain medication types (immunosuppressives and antibiotics), and pregnancy status. The instrument will also collect dates of planned travel to South(east) as well as preferred dates for study visits and reminder contacts.
~This instrument will be administered verbally by the study team and completed no more than 4 weeks prior to travel departure from the United States."
15979114|NCT03043300|Other|Pre-Travel Questionnaire|"The pre-travel questionnaire is a 29 item instrument collecting information about baseline characteristics, dietary habits, travel plans, and health history.
~This questionnaire will be administered verbally by the study team and completed 1 week prior to travel departure from the United States."
15979115|NCT03043300|Other|Pre-Travel Stool Specimen Collection|"The pre-travel stool specimen collection will occur 1 week prior to travel departure from the United States.
~The processing and analyses of this stool specimen will be performed by the Centers for Disease Control and Prevention."
15979116|NCT03043300|Other|Short-Term Post-Travel Questionnaire|"The short-term post-travel questionnaire is a 19 item instrument collecting information about dates and locations of travel, food and beverages consumed while traveling, and illnesses during or following traveling.
~This questionnaire will be administered verbally by the study team and completed 2 weeks after returning to the United States from travel."
15979117|NCT03043300|Other|Short-Term Post-Travel Stool Specimen Collection|"The short-term post-travel stool specimen collection will occur 2 weeks after returning to the United States from travel.
~The processing and analyses of this stool specimen will be performed by the Centers for Disease Control and Prevention."
15979118|NCT03043300|Other|Long-Term Post-Travel Questionnaire|"The long-term post-travel questionnaire is a 16 item instrument collecting information about illnesses since last study visit, dietary habits since last study visit, and any traveling since the last visit.
~This questionnaire will be administered verbally by the study team and completed 14 weeks after returning to the United States from travel."
15979119|NCT03043300|Other|Long-Term Post-Travel Stool Specimen Collection|"The short-term post-travel stool specimen collection will occur 14 weeks after returning to the United States from travel.
~The processing and analyses of this stool specimen will be performed by the Centers for Disease Control and Prevention."
15979120|NCT03043287|Biological|onabotulinumtoxinA|onabotulinumtoxinA (BOTOX®)100 to 200 U
15979121|NCT03043274|Drug|Cangrelor|Cangrelor 30 mcg/kg bolus followed by a 4 mcg/kg/min intravenous infusion prior to PCI will be given. It will be continued for ≥ 2 hours or for the duration of the procedure, whichever is longer.
15979122|NCT03043261|Behavioral|Williams LifeSkills|Online multi-media interactive training modules which address 10 core skills to improve coping, stress management and interpersonal relationships.
15979123|NCT03043248|Drug|TRK-700|repeated oral administration
15979124|NCT03043248|Drug|Digoxin|single oral administration with/without TRK-700
15979125|NCT03043248|Drug|Midazolam|single oral administration with/without TRK-700
15979126|NCT03043222|Device|UroLift as artifical device for prostatic urethral lift.|UroLift as artifical device for prostatic urethral lift. The PUL treatment is a minimally invasive approach to treating an enlarged prostate, or BPH, that lifts or holds the enlarged prostate tissue using clips so that it is out of the way so it no longer blocks the urethra. There is no cutting, heating or removal of prostate tissue.
15979127|NCT03043222|Device|Embospheres Microspheres as embolic agents for prostate artery embolization|Embospheres Microspheres as embolic agents for prostate artery embolization Arterial access will be obtained.Under live X-ray monitoring and using contrast, a catheter will be advanced into the artery to the prostate gland.Small micro spherical particles (Embopheres Microspheres) will be injected though the catheter to occlude the artery and cut off blood supply to the enlarged prostate. The prostate is then expected to shrink , thus relieving urinary symptoms related to prostate enlargement.There is no cutting or removal of prostate tissue.Once the procedure is complete, in case of wrist access compression will be achieved with a band; in case of groin access a closure device will be used to plug the site of entry.
15979128|NCT03043209|Genetic|Genomic sequencing|Genomic sequencing of DNA in Blood sample and myectomy tissue
15979129|NCT03043196|Drug|SRP plus Rosuvastatin gel|SRP followed by Rosuvastatin placement into intrabony defect
15979130|NCT03043196|Drug|SRP plus placebo gel|SRP followed by placebo gel placement into intrabony defect
15979131|NCT03043183|Procedure|perioperational nutrition surpport|Oral enteral nutrition support（25 kcal/kg or 1.5 g protein/kg） for 3 days before operation
15979132|NCT03043170|Device|Ultrasound Cardiac Output Monitor|a device for assessing haemodynamics continuously and non-invasively using Doppler wave ultrasound
15979133|NCT03043157|Drug|rocuronium|intravenous rocuronium infusion
15979134|NCT03043144|Other|Worsening of olfaction from enrollment visit to 6 months|Worsening of olfaction from enrollment visit to 6 months will be evaluated for association with the primary and secondary outcomes
15979135|NCT03043144|Other|Worsening of taste from enrollment visit to 6 months|Worsening of taste from enrollment visit to 6 months will be evaluated for association with the primary and secondary outcomes
15979136|NCT03043144|Other|Serum Zinc|Serum zinc will be evaluated for association with taste and/or smell impairment
15979137|NCT03043144|Other|Chronic rhinosinusitis|Chronic rhinosinusitis will be evaluated for association with smell impairment
15979138|NCT03043144|Other|Dialysis adequacy|Dialysis adequacy will be evaluated for association with taste and/or smell impairment
15979139|NCT03043144|Other|Decayed missing filled teeth index (DMFT)|DMFT will be evaluated for association with taste impairment
15979140|NCT03043131|Drug|Plasmalyte A|Plasma Lyte -A is administered intra operatively to maintain the hemodynamic status of patients
15979141|NCT03043131|Drug|Ringer Lactate|Ringer's lactate is administered intra operatively to maintain the hemodynamic status of patients
15979142|NCT03043118|Other|Variety Intervention|Vegetable flavor variety created with multiple herb and spice blends
15979143|NCT03043105|Drug|Thalidomide, cyclophosphamide and prednisone|"Thalidomide: 100mg QN for 1 year; And maintained with 100mg QN for the second year;
~Cyclophosphamide: 300mg/m2 on Day 1, 8, 15, 22 every month for 1 year;
~Prednisone: 1mg/kg on Day 1-2, 8-9, 15-16, 22-23 every month for 1 year."
15979144|NCT03043079|Diagnostic Test|Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity|Abdominal Ultrasound Acoustic Radiation Forced Impulse Shear Wave Velocity (ARFI-SWV)
15979145|NCT03043066|Procedure|Scaling and root planing|subjects underwent full mouth supragingival and subgingival scaling
15979146|NCT03043066|Drug|scaling and root planing along with antibiotic intervention|subjects underwent full mouth supragingival and subgingival scaling along with antibiotic intervention of amoxicillin of 500 mg and metronidazole of 400 mg thrice daily for 7 days
15979147|NCT03043053|Drug|oxytocin nasal spray|oxytocin intranasal spray
15979148|NCT03043053|Drug|Placebo|Placebo nasal spray
15979149|NCT03043040|Behavioral|Telephone follow up|Already described in previous page
15979150|NCT03043040|Behavioral|Treatment as usual|Already described in previous page
15979151|NCT03043027|Drug|liposomal bupivicaine|local anesthetic
15979152|NCT03043027|Drug|Bupivacaine|local anesthetic
15979153|NCT03043027|Drug|Saline Solution|saline injection
15979154|NCT03043014|Drug|Mifépristone versus Misoprostol|The women will be randomized into two groups: Mifépristone group and Misoprostol group. The main endpoint will be the per-operating pain. The other endpoints are the pre and post-operative pain, the complications (cervical tearing, uterine perforation, hemorrhage requiring the use of blood products or an hemostatic intervention), the surgical time necessary to terminate the pregnancy, the side-effects of the drugs. The amount of per-operating bleeding and the duration of the intervention . The investigators assume that the use of Mifepristone in the cervical preparation of the surgical abortion under LA would reduce the per-operating pain. The number of patients required is 55 in each arm.
15979155|NCT03043001|Drug|Memantine|All the subjects will receive add-on memantine for 12 week
15979156|NCT03042988|Other|Heating pad|Heat stress applied on the trunk for up to 8 hours
15979157|NCT03042988|Other|Sham control|heating pad turned off applied on the trunk for up to 8 hours
15979158|NCT03042975|Other|MRI|Functional and structural MRI of the brain will be conducted to identify disorder specific neural markers
15979159|NCT03042975|Procedure|Blood draw|Blood samples will be collected, the DNA will be extracted and banked for genetic studies.
15979160|NCT03042962|Other|MRI|Functional and structural MRI of the brain will be conducted to identify disorder specific neural markers
15979161|NCT03042962|Procedure|Blood draw|Blood samples will be collected, the DNA will be extracted and banked for genetic studies
15979162|NCT03042949|Device|Blood pressure measurement|Blood pressure measurement with a standard plethysmograph
15979163|NCT03042949|Device|Blood pressure measurement with the new device|Blood pressure measurement with the optical sensor, Elfor -1 device.
15979164|NCT03042936|Behavioral|Insulin Superheroes Club Curriculum|This curriculum promotes healthier physical activity, nutrition, sleep, and stress coping practices. The intervention lasts 12-months: registration, six evaluation sessions (2-3 hours per evaluation: Weeks 1, 8, and 16, 6-month, 9-month, and 12-month), and 16-weekly, 3-bi weekly, 6-monthly educational and physical activity sessions each lasting 90 minutes.
15979165|NCT03042923|Drug|lactulose:mannitol (L:M) oral challenge|
15979166|NCT03042910|Drug|Talazoparib|Talazoparib 1 mg orally once daily.
15979167|NCT03042897|Dietary Supplement|Dietary Intervention|Undergo DASH diet
15979168|NCT03042897|Behavioral|Exercise Intervention|Undergo in aerobic exercise
15979169|NCT03042897|Other|Laboratory Biomarker Analysis|Correlative studies
15979170|NCT03042897|Other|Quality-of-Life Assessment|Ancillary studies
15979206|NCT03042585|Radiation|Total body irradiation|When radiation is given in a way to cover the whole body, it is called total body irradiation.
15979207|NCT03042572|Drug|Allogeneic Mesenchymal Stromal Cell|Intramuscular allogeneic BM-MSC injection: MSCs will be extracted from BM of healthy volunteers, expanded with human platelet lysate, and stored. Patients will receive intramuscular allogeneic BM-MSC injections at 30 sites in the lower leg of the ischemic limb. Blinded syringes are provided and cell suspensions will be injected intramuscularly by an experienced operator into multiple sites (30 sites, 1-1.5cm in depth, volume of 1.0mL containing 5*10^6 MSC per site; total 150*10^6 BM-MSCs) in the ischemic lower extremity. Injections will be performed under IV analgesia (fentanyl) and sedation (midazolam) if necessary.
15979171|NCT03042884|Behavioral|Questionnaires|"Inpatient Group: Participants complete a questionnaire about any symptoms they may have had in the past 24 hours. The questionnaire should take about 5 minutes to complete.
~Within 24 hours of being discharged, same questionnaire about symptoms and a questionnaire about experience with the wearable exercise tracker. These questionnaires should take about 10 minutes total to complete.
~Outpatient Group: Participants complete 2 questionnaires about any symptoms they may have had in the past 24 hours and their current level of physical function. These should take about 10 minutes total to complete.
~At the end of the 14-day period, participant called by the study staff to remind them to complete the same 2 questionnaires about symptoms and level of physical function. Participants complete another questionnaire about their experience with the wearable exercise tracker. These questionnaires should take about 15 minutes total to complete."
15979172|NCT03042884|Device|Wearable Exercise Tracker Watch|"Inpatient Group: Participants receive a wearable exercise tracker watch upon admission to acute inpatient rehabilitation unit. Participant to wear the exercise tracker watch on their wrist for 24 hours a day. Device to be returned within 24 hours before being discharged.
~Outpatient Group: Participants receive a wearable exercise tracker watch to wear on their wrist for 24 hours a day for 14 days. Device to be returned at next visit."
15979173|NCT03042871|Drug|0.5mg intravitreal ranibizumab|Patients received ranibizumab (0.5mg, Novartis AG, Basel, Switzerland) via a pars plana transcleral injection through 30-gauge needle at 3.5 to 4mm of inferotemporal limbus. Levofloxacin eye drops ( Cravit Eye Drops, Santen, Japan) was instilled 4 times a day in the study eye before the treatment at least 1 day. Povidone-iodine (5%, Luofushan Pharmaceutical Co., China) was applied to the conjunctiva bulbi and the fornices for at least 3 minutes before injection. Patients were instructed to continue the levofloxacin eye drops 4 times a day for 3 days
15979174|NCT03042858|Other|Infants with PPV|Data will be collected for up to 18 years to monitor for inguinal hernia.
15979175|NCT03042858|Other|Infants without PPV|Basic data will be collected regarding the surgery and the subject's study participation will be complete.
15979176|NCT03042845|Device|Tiger cardiac catheter|Tiger cardiac catheter
15979177|NCT03042845|Device|Judkins 3.5L/4R cardiac catheters|Judkins 3.5L/4R cardiac catheters
15979178|NCT03042832|Behavioral|LOCI|Leadership development with coaching and organizational change support
15979179|NCT03042832|Behavioral|Internet Based Webinar Leadership Training|Internet Based Webinar Leadership Training
15979180|NCT03042819|Drug|Selinexor|Selinexor is a Selective Inhibitor of Nuclear Export (SINE) compound that binds and inactivates Exportin 1 (XPO1), thereby forcing the nuclear retention of key tumor suppressor proteins (TSPs).
15979181|NCT03042819|Drug|Doxorubicin|Doxorubicin is currently approved for various cancers. Doxorubicin inhibits DNA synthesis and repair by inhibiting topoisomerase II and also by intercalation between base pairs on the DNA helix. These actions result in the blockade of DNA and RNA synthesis and fragmentation of DNA.
15979182|NCT03042806|Behavioral|questionnaire|all the COPD patients will be ask to complete the questionnaire
15979183|NCT03042793|Biological|PD-L1 peptide vaccine|PD-L1 peptide given subcutaneously with Montanide ISA-51
15979184|NCT03042780|Drug|FOLFIRINOX|The FOLFIRINOX regimen consists of oxaliplatin given as a 2-hour intravenous infusion, immediately followed by leucovorin given as a 2-hour intra-venous infusion, with the addition, after 30 minutes, of irinotecan given as a 90-minute intravenous infusion. This study treatment is immediately followed by a continuous intravenous infusion of 5-Fluorouracil (5-FU) over a 46-hour period every 2 weeks.
15979185|NCT03042780|Drug|Granulocyte colony-stimulating factor (G-CSF)|The use of G-CSF will not be mandatory as primary prophylaxis, but will be allowed at investigators' discretion. If febrile neutropenia occurs, than the use of G-CSF will be mandatory after each following cycle of treatment.
15979186|NCT03042767|Biological|IMM-124E|IMM-124E is a hyper-immune, bovine colostrum (milk) powder with flavoring.
15979187|NCT03042767|Other|Placebo|Matched Placebo
15979188|NCT03042754|Diagnostic Test|XpertMTB/RIF|
15979189|NCT03042741|Biological|atherosclerosis vaccine|Atherosclerosis vaccine, V6, formulated as an oral pill made from from pooled antigens derived from adipose tissue
15979190|NCT03042741|Biological|Placebo pills|Half of the patients will be randomly assigned to receive placebo pill
15979191|NCT03042728|Behavioral|Dog Interaction|A therapy dog will visit the patients.
15979192|NCT03042728|Behavioral|Human Interaction|A human will visit the patients.
15979193|NCT03042715|Behavioral|Qualitative Interviews|phase 1 of the study entail refining the psychological intervention based on caregivers' feedback
15979194|NCT03042702|Drug|Kevetrin|Kevetrin dose to associated cohort
15979195|NCT03042702|Drug|Kevetrin|Kevetrin dose to associated cohort
15979196|NCT03042689|Drug|Regorafenib|Regorafenib will be administered on a 28 day cycle Treatment will be administered on outpatient basis at a pre-determine dosage.
15979197|NCT03042663|Procedure|USG stellate ganglion block|After verification of proper needle position and aspiration to exclude vascular spread, 1mL of the injectate will be injected to see proper tissue spread as well as patient response. After one minute the remaining volume will be injected under real time ultrasound imaging.
15979198|NCT03042650|Behavioral|Intensive Referral Intervention Group|The Intensive Referral Intervention Group will review a series of pamphlets regarding participation in 12-step meetings as well as smoking cessation that will be presented in a group setting to probationers in 3 sessions.
15979199|NCT03042650|Behavioral|Standard Practice Facilitated Group|The Standard Practice Facilitated Group will receive 3 sessions of the current standard practice for facilitated groups.
15979200|NCT03042637|Drug|Acthar Gel and Tacrolimus|Combination therapy with Acthar Gel and Tacrolimus (0.5-3.0 mg BID) following 6 months of ACTH therapy only
15979201|NCT03042624|Dietary Supplement|Fermented rice|7 g of powder obtained from Lactobacillus paracasei CBA L74
15979202|NCT03042624|Dietary Supplement|Maltodextrins|7 g of maltodextrins powder
15979203|NCT03042611|Drug|Apatinib|Daily oral dose of Apatinib plus Best Supportive Care defined as palliative non-cancer therapy at the Investigator's discretion
15979204|NCT03042611|Other|Placebo|Daily oral dose of Placebo with Best Supportive Care defined as palliative non-cancer therapy at the Investigator's discretion
15979205|NCT03042598|Device|Biphasic Cuirass Ventilation|The RTX Respirator will be applied to the patient's chest to provide non-invasive ventilatory support using a Biphasic Cuirass Ventilation technology to increase the safe apnic period during intubation.
15979208|NCT03042572|Other|Placebo|Intramuscular placebo injections. Patients will receive intramuscular placebo injections at 30 prespecified sites in the lower leg of the ischemic limb. Blinded syringes are provided and will be injected intramuscularly by an experienced operator into multiple sites (30 sites, 1-1.5cm in depth, volume of 1.0mL placebo per site) in the ischemic lower extremity. Injections will be performed under IV analgesia (fentanyl) and sedation (midazolam) if necessary.
15979209|NCT03042559|Device|Protonics Knee brace|The Protonics system has been introduced to physical therapists as a potential treatment for PFPS. The system includes a brace set to resist knee flexion and a set of specific exercises to perform daily. Through resistance to knee flexion, the system is advertised to decrease retropatellar contact pressure due to changes in pelvis inclination and available hip rotation. Specifically, resistance to knee flexion is purported to increase hamstring activity and inhibit the activity of the tensor fasciae latae and psoas muscles. The manufacturer asserts that prolonged use of the system results in greater hamstring activation, which leads to permanent structural changes through reciprocal inhibition at the hip and pelvis. The warm-up consisted of the subject wearing the ProtonicsTM knee brace set at a moderate resistance level and flexing the knees while sitting, standing, and reclining in the supine and prone positions.
15979210|NCT03042559|Device|Sports Cords|Subjects assigned to the sport cord group were asked to do the same warm-ups and exercises using the sport cord in the supine, standing, sitting, and prone positions. prone. The only difference is that subjects were asked to only walk backwards instead of forwards in order to avoid activation of the hip flexor muscle. The appropriate level of resistance for each subject was calculated by multiplying their weight in pounds by 0.3. Subjects were then given either light, medium, or heavy resistance cords according to the following classification scheme: light (pink color) with resistance 3 (R3), 0-30 lbs.; medium (orange color) with resistance 5 (R5) 0-50 lbs.; heavy (yellow color) with resistance 7 (R7) 0-70 lbs. All subjects completed three study visits, and a total of four measurements were taken at baseline, immediately following the first session, at two weeks, and at 4 weeks.
15979211|NCT03042546|Drug|Calcium Sulfate|Calcium Sulfate with abx will be used in the defect
15979212|NCT03042546|Drug|PMMA|PMMA with abx will be used in the defect
15979213|NCT03042546|Other|No treatment|The defect will not be treated
15979214|NCT03042533|Device|Conventional Compression|Method of Nail fitting
15979215|NCT03042533|Device|Standard Backslapping|Method of Nail fitting
15979216|NCT03042533|Device|Dynamic Locking with Backslapping|Method of Nail fitting
15979217|NCT03042520|Other|Observation only|
15979218|NCT03042507|Behavioral|Comprehensive Behavioral Intervention for Tics (CBIT)|The existing CBIT protocol includes a functional assessment procedure designed to identify relevant contextual variables (both antecedent and consequent) impacting tic expression and guide the development of an individualized behavioral program to neutralize these contextual influences in the service of tic reduction and psychoeducational component. Given the central role that negative social reactions typically play in tic exacerbation and maintenance, psychoeducation about tics is systematically provided to parents, siblings, and other caretakers and prominent individuals in the child's life. The other primary CBIT component, Habit Reversal Training (HRT), is used to weaken or eliminate the negative reinforcement cycle created by tic-contingent reduction in premonitory urge.
15979219|NCT03042494|Dietary Supplement|Control|Isocaloric food without the test prebiotic.
15979220|NCT03042494|Dietary Supplement|Prebiotic|Prebiotic consumed as 7 g/d in a snack food in Group 1 and consumed as 2.5-3 g/d in a snack food in Group 2.
15979221|NCT03042468|Drug|177Lu-PSMA-617|177Lu-PSMA-617 [50mCi (1.85GBq) - 300mCi (11.1GBq)] intravenous X2 doses, 2 weeks apart (Visit 1 and 2)
15979222|NCT03042468|Drug|68Ga-PSMA-HBED-CC|68Ga-PSMA-HBED-CC [5 ±2mCi or 185 ±74MBq] intravenous during screening and at 12 weeks with standard imaging
15979223|NCT03042455|Device|Armeo and rTMS|"The Armeo, a robot with a spring mechanism allowing adjustable arm weight support, can generate assistive forces of up to 66N in flexion/extension and up to 30N for the arm and forearm respectively. This robot integrates seven angle sensors and one pressure sensor that allow direct interaction between the motion of the patient's arm and the associated therapy software. rTMS is a magnetic method used to stimulate small regions of the brain.
~The Robot and rTMS group will receive the robot-assisted upper arm training and rTMS for 5 times per week, for 4 weeks. And all patients of three groups will receive the additional conventional occupational therapy for 30 minutes daily 5 times per week, for 4 weeks."
15979224|NCT03042455|Device|Armeo|The Armeo, a robot with a spring mechanism allowing adjustable arm weight support, can generate assistive forces of up to 66N in flexion/extension and up to 30N for the arm and forearm respectively. This robot integrates seven angle sensors and one pressure sensor that allow direct interaction between the motion of the patient's arm and the associated therapy software. The Robot group will receive the robot-assisted upper arm training for 30 minutes daily 5 times per week, for 4 weeks. And all patients of three groups will receive the additional conventional occupational therapy for 30 minutes daily 5 times per week, for 4 weeks.
15979225|NCT03042455|Other|Control group|The conventional group will receive occupational therapy for 30 minutes daily 5 times per week, for 4 weeks instead of Robot or rTMS. And all patients of three groups will receive the additional conventional occupational therapy for 30 minutes daily 5 times per week, for 4 weeks.
15979226|NCT03042442|Diagnostic Test|Point-of care biomarkers|Point-of care biomarkers(Activin,Midkine) assessed by WB and IHC
15979227|NCT03042442|Other|Clinical, venous blood samples, pancreatic tissue|Clinical evaluation, venous blood samples and pancreatic tissue needed for determining point-of-care biomarkers.
15979228|NCT03042442|Other|Follow-up|Participants will be assessed (by telephone) over a period of 2 years
15979229|NCT03042429|Drug|Cycles N8, N5 and N6|two chemotherapy cycles N8 followed by standard arm therapy
15979230|NCT03042429|Drug|Cycles N5 and N6|Standard arm six chemotherapy cycles (3xN5 and 3x N6) followed by myeloablative therapy with stem cell support and isotretinoin
15979231|NCT03042416|Drug|18F-DOPA|18F-DOPA intravenous injection single dose
15979271|NCT03042078|Device|Conventional fluoroscopic ablation|Catheter ablation will be performed under the guidance of Ensite NavX plus fluoroscopy.
15979272|NCT03042065|Device|vibrating Mesh nebulizer|Receive in the same aerosol solution 5 mg of Salbutamol (Ventolin, Glaxo, 5 mg / ml solution for nebulization) mixed with 0.5 mg Ipratropium Bromide (0.25 mg / ml) by nebulization every 20 min For 3 doses during the first hour of treatment, using vibrating Mesh nebulizer
15979232|NCT03042403|Other|Breath stacking|During initial rest period, the volunteer remained seated for 10' in spontaneous breathing. Right after, the measurement of arterial pressure, of SpO2 (%), of heart rate, of respiratory frequency and applied to a modified effort perception Borg. During carrying out of the breath stacking technic, the volunteer remained seated, being requested to hold the mask on his/her face not allowing air scape, The volunteer was oriented to inhale normally and exhale all the air during expiration for 20 seconds, and the variables were assessement again the same variables of control. In the final rest period, right after technic end, the volunteers remained seated for 10 minutes in spontaneous breathing and again the same variables of control at the 10th minute were assessed.
15979233|NCT03042377|Other|Single-Visit Retreatment|The teeth in this group were treated according to the guidelines for root canal retreatment in single-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were obturated with gutta percha and coronal restoration was made using composite and/or fully crown if necessary.
15979234|NCT03042377|Drug|"Multiple-Visit-Calcium Hydroxide"|The teeth in this group were treated according to the guidelines for root canal retreatment in multiple-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were treated with calcium hydroxide and the cavity was filled with temporary restorative material.
15979235|NCT03042377|Drug|"Multiple-Visit-Corticosteroid Paste"|The teeth in this group were treated according to the guidelines for root canal retreatment in multiple-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were treated with corticosteroid & antibiotic paste and the cavity was filled with temporary restorative material.
15979236|NCT03042377|Drug|"Multiple-Visit-Antibiotic Paste"|The teeth in this group were treated according to the guidelines for root canal retreatment in multiple-session. The filling was removed and cavity was opened. Then root canal filling was removed from the root canals completely using retreatment kit. After irrigation protocol, root canals were treated with an antibiotic paste and the cavity was filled with temporary restorative material.
15979237|NCT03042364|Other|Pipelle de Cornier|RCT with endometrial scratching prior to hormone treatment in ART. Aspiration of uterine secretion at transfer day
15979238|NCT03042351|Device|Magic Kegel app|Pelvic floor muscles recover exercises with a specific device and Magic Kegel App
15979239|NCT03042338|Behavioral|CET: Central Executive Training|CET: Central Executive Training
15979240|NCT03042338|Behavioral|CET: Comparison Executive Training|CET: Comparison Executive Training
15979241|NCT03042325|Drug|Alogliptin|Alogliptin tablets
15979242|NCT03042312|Drug|177Lu-PSMA-617|Lutetium (177Lu) -DOTA (1,4,7,10-tetra-azacyclododecane-N,N',N'',N'''-tetraacetic acid )-PSMA has three components: PSMA is the targeting vector , DOTA (1, 4, 7, 10-tetraazacyclododecane-1, 4, 7, 10-tetraacetic acid) is a radiometal chelator and a linking group, and 177Lu is the beta emitter that upon internalization delivers radiation to the nucleus of tumor cells to cause DNA damage. The targeting vector utilizes glu-urea-lys sequence which is an inhibitor capable of binding to the domain of PSMA. These components have been previously used in human subjects and in medical research.
15979243|NCT03042299|Drug|TAK-536|TAK-536 granules.
15979244|NCT03042299|Drug|TAK-536|TAK-536 tablet.
15979245|NCT03042273|Dietary Supplement|High Strength Cranberry|Softgel capsule
15979246|NCT03042273|Dietary Supplement|Placebo|Soy oil to match High Strength Cranberry Softgel Capsule
15979247|NCT03042260|Drug|Trimethoprim-Sulfamethoxazole|oral tablets, 3 times a week, for a minimum of 6 months and maximum of 1 year.
15979248|NCT03042260|Drug|Placebo Oral Tablet|oral tablets, 3 times a week, for a minimum of 6 months and maximum of 1 year.
15979249|NCT03042247|Diagnostic Test|FDG PET/TC and FDG PET/MRI|Combined assessment with FDG PET/TC and PET/MRI
15979250|NCT03042234|Other|Group Insulin-Resistant|High intensity interval training: 3 to 6 sets of 60-second sprints at 100% of the peak velocity interspersed by a 3-min active recovery period.
15979251|NCT03042234|Other|Group Insulin-Sensitive|High intensity interval training: 3 to 6 sets of 60-second sprints at 100% of the peak velocity interspersed by a 3-min active recovery period.
15979252|NCT03042208|Other|Self guided handout|Written handout with basic weight management strategies
15979253|NCT03042208|Behavioral|Weight Watchers|Access to Weight Watchers in-person meetings and online tools
15979254|NCT03042195|Other|Parenteral Nutrition|Supplementary parenteral nutrition to achieve 100% coverage of estimated needs
15979255|NCT03042182|Biological|Oral therapeutic vaccine V3-X to treat cholangiocarcinoma|One single pill of V3-X vaccine administered once per day to patients with cholangiocarcinoma
15979256|NCT03042169|Drug|Preoperative Chemotherapy|Standard chemotherapy regiments according to risk of recurrence
15979257|NCT03042169|Procedure|Surgery|the surgical treatment will undergo gastrectomy between D1 and D30 after randomization.
15979258|NCT03042169|Drug|Postoperative chemotherapy|Chemotherapy should be restarted between D1 and D30 post-randomization
15979259|NCT03042156|Radiation|Palliative Radiation Therapy|
15979260|NCT03042143|Biological|Human umbilical cord derived CD362 enriched MSCs|Infusion of Human umbilical cord derived CD362 enriched MSCs
15979261|NCT03042143|Biological|Placebo (Plasma-Lyte 148)|Infusion of placebo
15979262|NCT03042130|Other|Standard of care|standard of care
15979263|NCT03042130|Drug|Iron Carboxymaltose|Two IV doses
15979264|NCT03042117|Other|periodontal probing|A periodontal probe will be inserted between the tooth and the gum in the gingival sulcus and a measurement of the pocket depth will be measured by a trained dentist in all subjects
15979265|NCT03042104|Device|Edwards SAPIEN 3 / SAPIEN 3 Ultra THV|Patients will receive the SAPIEN 3 / SAPIEN 3 Ultra THV.
15979266|NCT03042091|Drug|Polyethylene Glycol|Given orally
15979267|NCT03042091|Drug|Neomycin|Given orally
15979268|NCT03042091|Drug|Metronidazole Hydrochloride|Given orally
15979269|NCT03042091|Procedure|Therapeutic Conventional Surgery|Undergo colorectal resection
15979270|NCT03042078|Device|Zero-fluoroscopic ablation|Catheter ablation will be performed under the guidance of Ensite NavX and without the use of fluoroscopy.
15979440|NCT03040973|Drug|capmatinib|tablet for oral use 400 mg BID
15979273|NCT03042065|Device|jet nebulizer|Receive in the same aerosol solution 5 mg of Salbutamol (Ventolin, Glaxo, 5 mg / ml solution for nebulization) mixed with 0.5 mg Ipratropium Bromide (0.25 mg / ml) by nebulization every 20 min For 3 doses during the first hour of treatment, using jet nebulizer
15979274|NCT03042052|Drug|detrusor infection of Botulinum toxin|detrusor injection
15979275|NCT03042039|Other|New Care|New organisational care model delivering integrated healthcare (IHC) supported by ICT infrastructure (electronically shared-care platform).
15979276|NCT03042013|Drug|ASP8273|Oral
15979277|NCT03042000|Other|non-NCRT|without the preoperative concurrent chemoradiothearpy (no neoadjuvant chemoradiation)
15979278|NCT03042000|Other|NCRT|the preoperative concurrent chemoradiothearpy (neoadjuvant chemoradiation)
15979279|NCT03042000|Drug|capecitabine with oxaliplatin|combined chemotherapy with capecitabine with oxaliplatin
15979280|NCT03042000|Drug|capecitabine|single-agent chemotherapy with capecitabine
15979281|NCT03042000|Procedure|TEM|transanal endoscopic microsurgery (TEM) excision of the lesion
15979282|NCT03042000|Procedure|radical resection|radical resection of rectal cancer
15979283|NCT03041987|Other|Demographic factors, biomedical measurements, drugs used for controlling metabolic disorders, etc|
15979284|NCT03041974|Procedure|Red Blood Cell transfusion|
15979285|NCT03041974|Procedure|Microparticles quantification|Flow cytometric quantification of microparticles in transfused blood
15979286|NCT03041961|Dietary Supplement|Placebo|Identical formulation as the treatment consisting of colored maltodextrin using artificial colors.
15979287|NCT03041961|Dietary Supplement|Aronia full spectrum|Powdered whole fruit obtained from aronia berries (Aronia melanocarpa)
15979288|NCT03041961|Dietary Supplement|Aronia extract|Powdered extract obtained from aronia berries (Aronia melanocarpa)
15979289|NCT03041948|Procedure|Ilioinguinal/iliohypogastric nerve block|See arm description
15979290|NCT03041948|Procedure|Caudal-epidural nerve block|See arm description
15979291|NCT03041948|Drug|Acetaminophen|See arm description
15979292|NCT03041948|Drug|Sevoflurane|See arm description
15979293|NCT03041948|Drug|Remifentanil|See arm description
15979294|NCT03041948|Drug|Propofol|See arm description
15979295|NCT03041948|Drug|Morphine|See arm description
15979296|NCT03041948|Drug|Ondansetron|See arm description
15979297|NCT03041948|Drug|Dexamethasone|See arm description
15979298|NCT03041948|Drug|Ketorolac|See arm description
15979299|NCT03041935|Procedure|Ilioinguinal/iliohypogastric nerve block|See arm description
15979300|NCT03041935|Procedure|Caudal-epidural nerve block|See arm description
15979301|NCT03041935|Drug|Acetaminophen|See arm description
15979302|NCT03041935|Drug|Sevoflurane|See arm description
15979303|NCT03041935|Drug|Remifentanil|See arm description
15979304|NCT03041935|Drug|Propofol|See arm description
15979305|NCT03041935|Drug|Morphine|See arm description
15979306|NCT03041935|Drug|Ondansetron|See arm description
15979307|NCT03041935|Drug|Dexamethasone|See arm description
15979308|NCT03041935|Drug|Ketorolac|See arm description
15979309|NCT03041935|Drug|Ropivacaine|See arm description
15979310|NCT03041909|Drug|GBT440|Oral drug
15979311|NCT03041896|Device|coflex® Interlaminar Technology|Interlaminer Technology
15979312|NCT03041883|Procedure|Crosslinking with riboflavin of the corneal graft-support|Corneal graft support for the KPro will be crosslinked and used with the standard surgical technique
15979313|NCT03041883|Procedure|De-epithelisation of the corneal graft support with instillation of riboflavin|Corneal graft-support will be de-epithelialized and soaked with riboflavin and then used with the standard surgical technique
15979314|NCT03041870|Device|PET-fMRI scan|fMRI scan include MR sequences: BOLD and fMRI. The PET acquisition will be carried out in dynamic for 90 consecutive minutes following intravenous administration of 4 MBq / kg dose of [11C]DASB bolus.
15979315|NCT03041857|Radiation|Observational use of fluoroscopy|
15979316|NCT03041844|Device|Low Frequency, Low Intensity Ultrasound|Therapeutic ultrasound (20 kHz, <100 mW/cm2 spatial peak-temporal peak)
15979317|NCT03041844|Device|Sham Applicator|Sham ultrasound applicator
15979318|NCT03041818|Behavioral|Horseback riding therapy|Apply 30 minutes/session, twice a week for 8 weeks of horseback riding therapy (provided with 1 horse rider, 2 side walkers)
15979319|NCT03041805|Procedure|EVLT|Endovenous laser treatment of great saphenous vein, small saphenous vein, accessorial saphenous vein with different laser wavelength and any bare type
15979320|NCT03041805|Procedure|RFA|Radiofrequency ablation of great saphenous vein, small saphenous vein, accessorial saphenous vein with ClosureFast technique
15979321|NCT03041805|Procedure|USFS|Ultrasound guided foam sclerotherapy of great saphenous vein, small saphenous vein, accessorial saphenous vein with polidocanol or tetradecyl sulphate of any concentration
15979322|NCT03041805|Procedure|HL/stripping|High ligation and stripping of great saphenous vein, small saphenous vein, accessorial saphenous vein
15979323|NCT03041805|Procedure|Miniphlebectomy|Miniphlebectomy of any varicose veins under local, regional or general anaesthesia
15979324|NCT03041805|Procedure|Sclerotherapy|Foam or liquid sclerotherapy of any varicose veins with polidocanol or tetradecyl sulphate of any concentration
15979325|NCT03041805|Device|GCS|Graduated compression stockings may be used after procedure by the decision of the doctor
15979326|NCT03041805|Drug|LMWH|Low-molecular-weight heparin may be used after procedure by the decision of the doctor
15979327|NCT03041792|Drug|Liraglutide|Liraglutide
15979328|NCT03041792|Other|Placebo|Placebo
15979329|NCT03041779|Drug|Diclofenac Sodium 50Mg Suppository|
15979330|NCT03041779|Drug|Paracetamol 500Mg Suppository|
15979331|NCT03041766|Biological|Sm14|Three 0.5 mL intra-muscular injections of the vaccine solution (50µg Sm14) will be administered on D0, W4, W8 (D = day, W = week).
15979332|NCT03041766|Drug|GLA-SE solution|Two (2) adjuvant concentrations will be made and packaged at 0.4 mL/vial, per GMP standards. One lot at the concentration of 10µg/mL for injection in the first cohort at 2.5µg GLA-SE/injection and one lot at the concentration of 20µg/mL for the second cohort intended to receive 5.0µg of GLA-SE/injection
15979441|NCT03040973|Drug|Nazartinib|Tablets/Capsules for oral use 100 mg QD
15979333|NCT03041740|Drug|Perfluorooctyl Bromide|Subjects in the PFOB group will receive PFOB partial liquid ventilation instilled via side port of endotracheal tube (2.5 mL/kg/day) across 10 treatment days.
15979334|NCT03041727|Other|Fascial Manipulation|Fascial Manipulation is a manual therapy that focused on deep muscular fascial.
15979335|NCT03041727|Other|Standard exercises protocol|Stretching and strengthening exercises
15979336|NCT03041701|Drug|Dasatinib|Once daily on days -7 through day 27 during cycle 1, and then days 0-27 for subsequent cycles.
15979337|NCT03041701|Drug|Ganitumab|Once every 2 weeks beginning on day 0.
15979338|NCT03041688|Drug|Decitabine|Given IV
15979339|NCT03041688|Drug|MDM2 Inhibitor KRT-232|Given PO
15979340|NCT03041675|Device|Laser Acupuncture group|47 participants receive 10 seconds of Laser Acupuncture(808nM/300mW) on acupoints RN6, RN4, and RN12. The whole duration of treatment is 3 times a week, for 8 weeks.
15979341|NCT03041675|Device|Sham Laser Acupuncture group|The investigators apply the Laser Acupuncture pen (without pressing the Laser button) on other 47 participants' acupoints RN6, RN4, and RN12. The whole duration of treatment is 3 times a week, for 8 weeks.
15979342|NCT03041662|Diagnostic Test|MR/MRCP|MR/MRCP
15979345|NCT03041636|Drug|Ruxolitinib|Given PO
15979346|NCT03041636|Drug|Ruxolitinib Phosphate|Given PO
15979347|NCT03041610|Behavioral|Walking intervention|The intervention will be delivered over a six-month period and will consist of: (1) an individualized pedometer-based walking program with weekly step goals, (2) regular visits to the clinic including face-to-face session with the physician, and (3) regular telephone calls with the research nurse in between the face-to-face contacts.
15979348|NCT03041597|Procedure|placement of implants|surgical procedure and placement of implants
15979349|NCT03041597|Procedure|immediate loading|cone-anchored implant supported removable dental prostheses placement
15979350|NCT03041597|Procedure|conventional loading|cone-anchored implant supported removable dental prostheses placement in 3mo
15979351|NCT03041597|Device|Ankylos implant|
15979352|NCT03041584|Procedure|Guided placement|implant placement with use of guide
15979353|NCT03041584|Procedure|Non-guided placement|conventional implant placement
15979354|NCT03041584|Device|Astra Tech TX implant|
15979355|NCT03041571|Behavioral|Patient Provider Orientation Scale|Investigators are interested in the impact that our activity has on the students' patient-centeredness. Investigators will use the Patient-Practitioner Orientation Scale (PPOS), which will be completed by both the student and the patient prior to the encounter. Following the interview, the co-investigators will lead a discussion with the patient and student. Investigators will discuss differences in patient and student PPOS scores, and how each party felt the interview went. Investigators will examine if the patients feel the interview differed from typical interactions with health care providers, and how this made the patient feel. The students will describe what was learned from the patients story as well as try to explore reasons why providers may not always learn the patient's illness story.
15979356|NCT03041571|Behavioral|Interview performed by MHP student|"The MHP students took a course called Medical Humanities in the fall of 2016. MHP students learned patient interviewing skills and the importance of gathering the patients illness story. The students will conduct an interview with a patient with chronic illness, which will be focused on gather information about how the patients illness affects daily life as well as interactions with the health care system."
15979357|NCT03041558|Behavioral|SafeCare+ (SC+)|SafeCare intervention with the additional Healthy Relationships (HR) module
15979358|NCT03041558|Behavioral|SafeCare (SC)|SafeCare intervention as usual
15979359|NCT03041545|Device|Fitbit|Women enrolled in the study will be asked to wear a Fitbit from one week prior to chemotherapy until six months post-chemotherapy. The Fitbit is a watch-sized, wrist worn, physical activity tracker. A button, when pressed, displays the wearer's accumulated daily steps, mileage, and steps climbed.
15979360|NCT03041532|Procedure|Proximal retroflexion|The investigator explore twice right colon, first front view and second forward viewing or proximal retroflexion depends on randomization
15979361|NCT03041532|Procedure|Frontal view|The investigator explore twice right colon with frontal viewing
15979362|NCT03041519|Procedure|Zero-fluoroscopy ablation|Catheter ablation will be performed under the guidance of Ensite NavX and without fluoroscopy.
15979363|NCT03041519|Procedure|Conventional fluoroscopy ablation|Catheter ablation will be performed under the guidance of fluoroscopy pllus Ensite NavX.
15979364|NCT03041506|Drug|Lidocaine|"Infiltration of local anesthetic agents around target nerves (C5, C6 nerve roots), US guidance, for shoulder pain relief and muscle relaxation.
~Lidocaine 2%: 15 -20 ml."
15979365|NCT03041506|Procedure|US guided ISCB|"Infiltration of local anesthetic agents around target nerves (C5, C6 nerve roots), US guidance, for shoulder pain relief and muscle relaxation.
~Lidocaine 2%: 15 -20 ml."
15979366|NCT03041506|Drug|Midazolam|IV administration up to a maximum dosage of 0.1 mg/kg (bolus of 1 mg by titration every 30-60 seconds) for sedation and pain relief.
15979367|NCT03041506|Drug|Ketamine|IV administration up to maximum dosage of 100 mg IV (bolus of 25 mg by titration every 30-60 seconds) for sedation and pain relief.
15979368|NCT03041493|Behavioral|Electronic cigarette|During the first encounter, blood pressure and endothelium-dependent relaxation (EDR) will be measured by flow mediated dilatation (FMD), and a small peripheral IV catheter will be placed in the participant's median antecubital or cephalic vein. A blood sample (10 mL) for EPCs and F2-isoprostanes will be collected. One urine sample will also be collected for measurement of urinary F2-isoprostanes, cotinine and creatinine. These will serve as both baseline measures for subsequent acute exposure to nicotine and as measures of chronic nicotine exposure. The second encounter will be scheduled 4 hours after the first encounter. At that time a blood sample (5 mL) for EPCs will be collected followed by harvesting of vascular endothelial cells for eNOS and NF-κB expression.
15979442|NCT03040973|Drug|Gefitinib|tablets for oral use 250mg QD
15979443|NCT03040947|Other|Cardiovascular Magnetic Resonance|
15979489|NCT03040609|Behavioral|Test at 6 months|To perform the classification with the scale by orthoptist at the end 6 months.
15979369|NCT03041493|Behavioral|traditional cigarette|During the first encounter, blood pressure and endothelium-dependent relaxation (EDR) will be measured by flow mediated dilatation (FMD), and a small peripheral IV catheter will be placed in the participant's median antecubital or cephalic vein. A blood sample (10 mL) for EPCs and F2-isoprostanes will be collected. One urine sample will also be collected for measurement of urinary F2-isoprostanes, cotinine and creatinine. These will serve as both baseline measures for subsequent acute exposure to nicotine and as measures of chronic nicotine exposure. The second encounter will be scheduled 4 hours after the first encounter. At that time a blood sample (5 mL) for EPCs will be collected followed by harvesting of vascular endothelial cells for eNOS and NF-κB expression.
15979370|NCT03041493|Behavioral|(sham cigarette) - no actual exposure to cigarettes|During the first encounter, blood pressure and endothelium-dependent relaxation (EDR) will be measured by flow mediated dilatation (FMD), and a small peripheral IV catheter will be placed in the participant's median antecubital or cephalic vein. A blood sample (10 mL) for EPCs and F2-isoprostanes will be collected. One urine sample will also be collected for measurement of urinary F2-isoprostanes, cotinine and creatinine. These will be compared to the second set of laboratory measurements done at the second encounter that will be scheduled 4 hours after the first encounter. At that time an additional blood sample (5 mL) for EPCs will be collected followed by harvesting of vascular endothelial cells for eNOS and NF-κB expression.
15979371|NCT03041480|Diagnostic Test|serum lipid levels and Lp-PLA2|Estimation of Total Cholesterol, triglyceride, High density lipoprotein, Low density lipoprotein, very low density lipoprotein and Lipoprotein associated lipophosphase A2 in chronic periodontitis
15979372|NCT03041467|Device|IN.PACT AV DCB|IN.PACT™ AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon
15979373|NCT03041467|Device|Standard Balloon Angioplasty|Standard PTA Balloon
15979374|NCT03041454|Other|Novel systematic review format|A 2-page summary of systematic review content that has been designed in collaboration with policy makers and health care managers.
15979375|NCT03041441|Device|MRI algorithm|MRI sequences have been developed that may be able to estimate intracranial pressure in a non-invasive fashion
15979376|NCT03041441|Procedure|Lumbar puncture|Lumbar puncture according to the standard-of-care treatment plan.
15979377|NCT03041441|Procedure|Epidural patching|Epidural patching will be performed to the standard-of -care treatment plan
15979378|NCT03041428|Device|Ultraprotective ventilation|Adjusting ventilator parameters for 3 ml/kg of tidal volume in order to achieve the ultra protective strategy
15979379|NCT03041415|Behavioral|ALED Alone Physical Activity Program|• 12-week class focused on teaching self-regulatory skills to increase regular PA
15979380|NCT03041415|Behavioral|ALED + Our Voice PA Program|"12-week class focused on teaching self-regulatory skills to increase regular PA
~Neighborhood assessment, consensus-building, & advocacy program in which participants are taught skills to promote neighborhood-level changes in support of regular Physical activity"
15979381|NCT03041402|Other|PSP|PSP, setting the inspiratory pressure support ≥8 cmH2O to obtain a tidal volume of 6-8 mL•kg-1 of body weight, the fastest rate of pressurization (0.0 sec) and I/E cycling at 35% of peak inspiratory flow
15979382|NCT03041402|Other|NAVA|NAVA, adjusting the NAVA level in order to achieve a comparable peak EAdi (EAdipeak) as during PSP with a safety Paw upper limit of 30 cmH2O
15979383|NCT03041402|Other|PSN|PSN, setting the NAVA level at its maximum (i.e; 15 cmH2O/mcV), and an upper Paw limit such to obtain the same overall Paw applied during PSP
15979384|NCT03041389|Behavioral|CCBT-I Group|Every patient will have a unique password to access to CCBT-I. The program consists of 5 cores: sleep log, day's lesson, activities, relaxation and progress. Each day, the patients fill in sleep logs before getting the day's lesson. Filling sleep log will be reminded daily by the program coach from Sleep Center.
15979385|NCT03041389|Behavioral|Control Group|Reading material only including recommendations about sleep hygiene, stimulus control and sleep restriction. Access to the CCBT-I program through the internet (Cleveland Clinic Wellness Go! To Sleep six-week online program), if proven effective, after the study is completed.
15979386|NCT03041376|Behavioral|Walking intervention|The intervention will be delivered over a six-month period and will consist of: (1) an individualized pedometer-based walking program with weekly step goals, (2) regular visits to the clinic including face-to-face session with the physician, and (3) regular telephone calls with the research nurse in between the face-to-face contacts.
15979387|NCT03041363|Drug|Triheptanoin|Triheptanoin will be administered for 7 days 4 times daily.
15979388|NCT03041350|Other|Smartphone video-assisted ALS(advanced life support)|As an preparation for this study, personnel training in mock advanced life support (ALS) simulation including the smartphone video call methodology was conducted. The smartphones were not separately purchased or produced; commercially available smartphones already owned by the emergency medical service (EMS) personnel and medical directors were used. To facilitate the smartphone video call between the medical director and the EMS personnel and to prevent the caregivers or others nearby from hearing the conversation, Bluetooth earphone sets were used. Data were collected using the cardiopulmonary resuscitation (CPR) recording form uploaded in SNS which consisted of EMS personnel and medical directors, and the quality of CPR was evaluated
15979389|NCT03041337|Diagnostic Test|stress echocardiography|"stress echocardiography will be performed in accordance with the current guidelines on a variable load 45° cycle ergometer with an incremental workload of 25 W every 2 minutes up to the symptom-limited maximal tolerated workload. Echocardiographic measurements will be acquired at baseline, at peak exercise and during recovery of 5 minutes.
~The electrocardiogram and blood pressure will be monitored at each workload. Termination criteria and / or positive test criteria for inducible myocardial ischemia will follow the current recommendations"
15979390|NCT03041324|Biological|SB-913|Single dose of each of the 3 components of SB-913: ZFN1, ZFN2 and hIDS Donor
15979391|NCT03041311|Drug|Trilaciclib|Trilaciclib IV
15979392|NCT03041311|Drug|Placebo|Placebo IV
15979393|NCT03041311|Drug|Carboplatin|Carboplatin IV
15979394|NCT03041311|Drug|Etoposide|Etoposide IV
15979395|NCT03041311|Drug|Atezolizumab|Atezolizumab IV
15979396|NCT03041298|Procedure|MR mammography with Dotarem|
15979444|NCT03040934|Device|Firehawk sirolimus target eluting coronary stent system|98 subjects will be enrolled to receive a test device of Firehawk sirolimus target eluting coronary stent system
15979490|NCT03040596|Drug|Fluticasone propionate|fluticasone inhaler 44mcg/puff, 2 puffs twice a day for 4 weeks
15979397|NCT03041285|Drug|idronoxil (NOX66) suppository|"Patients in Group 1 will be given 400mg of Idronoxil suppository (NOX66) (1 suppository) daily from Day 0(1 day before radiotherapy) until 7 days after radiotherapy. Group 2 will be given Idronoxil (NOX66) 800mg (2 suppositories) daily from Day 0 until 7 days after radiotherapy.
~All patients will receive one course of Stereotactic Body Radiation Therapy (SBRT), to be delivered in 20 Gray in 5 fractions.
~Radiotherapy session will involve irradiation of 1-2 lesions.
~."
15979398|NCT03041285|Radiation|Stereotactic Body Radiation Therapy|All patients (Group 1 and Group 2) will receive one course of Stereotactic Body Radiation Therapy (SBRT), to be delivered in 20 Gray in 5 daily fractions on consecutive days. Radiotherapy session (week 1) will involve irradiation to 1-2 lesions.
15979399|NCT03041259|Drug|Rejuveinix Low Dose|A intravenous administration of Rejuveinix after standard mechanical intervention of blocked peripheral artery
15979400|NCT03041259|Drug|Rejuveinix High Dose|A intravenous administration of Rejuveinix after standard mechanical intervention of blocked peripheral artery
15979401|NCT03041246|Procedure|Pelvic floor fascial mobilization|The manual manipulation of the pelvic floor involves intra vaginal superficial as well as pelvic skin area pressure points.
15979402|NCT03041233|Other|Observation / Data Collection|"The following data will be reviewed / collected:
~BASELINE VISIT: Patient demographics; Atrial fibrillation History; Cardiovascular history; Cardiac medical history.
~ABLATION PROCEDURE: Devices used; Ablation parameters; Ablation success definition and result; Operator feedback (Device combination chosen, device maneuverability, ease of use in combination with other device); Number, experience and type of attending personnel; Definition of standard of care (follow-up procedures and occurrence).
~6 and 12 MONTH FOLLOW-UP (+/- 30 DAYS): Recurrence of atrial arrhythmias: list of atrial arrhythmias since last visit, classify episodes, duration of the episodes; Changes in therapy; In case of Repeat Ablation Procedures, reconnections and new ablations will be recorded."
15979403|NCT03041220|Procedure|cesarean section|obese patients (BMI of 30 or greater) who have had a cesarean section
15979404|NCT03041207|Behavioral|Development and implementation of an antibiotic guideline|A consensus conference will develop and then implement a guideline for stopping vs. continuing antibiotics in infants with suspected ventilator-associated infection
15979405|NCT03041194|Other|dietary affects|Dietary affects on urine pH in relation to Interstitial cystitis symptoms
15979406|NCT03041181|Drug|Docetaxel|Docetaxel 75 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)
15979407|NCT03041181|Drug|Nivolumab|Nivolumab 360 mg IV Day 1 of each cycle (21 days = 1 cycle)
15979408|NCT03041181|Drug|Gemcitabine|Gemcitabine 1000 mg/m2 IV Day 1 and Day 8 of each cycle (21 days = 1 cycle)
15979409|NCT03041181|Drug|Pemetrexed|Pemetrexed 500 mg/m2 IV Day 1 of each cycle (21 days = 1 cycle)
15979410|NCT03041168|Device|Carotid Stenotic Scan|Each subject will have been scheduled for a carotid ultrasound, or other imaging test of the neck (carotids) as ordered by his/her physician for clinical or screening purposes. These studies will be read by a Jefferson radiologist and a report generated for standard clinical purposes. These reports and the images will be collected and de-identified to be used as comparator measurements to the CSS results. The CSS device is shaped like a stethoscope with 3 small gel pads. It is positioned with a gel pad on either side of the neck and one on the front of the chest. The scan takes about 1-2 minutes to provide an image on the screen of the device cart. The scan device pads just lie on the skin and do not use any invasive techniques to provide the image.
15979411|NCT03041155|Behavioral|Muscle respiratory training|Muscle respiratory training during hemodialysis sessions
15979412|NCT03041142|Behavioral|Interdisciplinary intervention|Physical Activity, nutrition and Psychological
15979413|NCT03041142|Other|Routine|The participants continued to maintain their routine
15979414|NCT03041129|Diagnostic Test|oral glucose tolerance test|6 hours OGTT
15979415|NCT03041129|Diagnostic Test|MRI of liver|MRI of the liver and use of DIXON method
15979416|NCT03041116|Drug|Fosmetpantotenate|Daily dosing
15979417|NCT03041116|Drug|Placebo|Daily dosing
15979418|NCT03041103|Other|Food Product 1|50 grams of fortified nutritious product from legumes
15979419|NCT03041090|Device|Lucerno ID (identification) System|The Lucerno ID is intended to dynamically measure the uptake of radiotracer in a particular organ or body region during the radiotracer uptake period as part of nuclear medicine (NM) procedures. The Lucerno ID is indicated for use as a tool for trained healthcare professionals (technologists, NM physicians, and radiologists) to help assess whether a radiotracer injection has resulted in an infiltration. The LD ID can be used by healthcare professionals including nuclear medical technologists, nuclear medicine physicians, or any other medical staff in a NM facility, once they have received the necessary training into the use of the system.
15979420|NCT03041077|Dietary Supplement|Instaflex Advanced|Joint function
15979421|NCT03041077|Dietary Supplement|Placebo|Placebo
15979422|NCT03041064|Other|50/100|SPF
15979423|NCT03041064|Other|100/50|SPF
15979424|NCT03041051|Biological|PCV13|
15979425|NCT03041051|Biological|PPV23|
15979426|NCT03041038|Drug|Secukinumab|Anti IL-17A antibody
15979427|NCT03041038|Drug|Placebo|
15979428|NCT03041025|Drug|GSK2330811|GSK2330811 will be provided in vials and packed in 1 vial per carton. Each vial will contain 1.2 mL fill with 1 mL extractable volume at 100 mg/mL.
15979429|NCT03041025|Drug|Placebo|Normal saline (0.9 percent weight per volume sodium chloride).
15979430|NCT03041012|Drug|Romidepsin|5mg/m2 romidepsin will be administered IV on days 10, 17, and 24 after initiating ART
15979431|NCT03041012|Drug|3BNC117|30 mg/kg 3BNC117 will be administered IV on day 7 and 21 after initiating ART
15979432|NCT03041012|Drug|Antiretrovirals|Combination antiretroviral therapy
15979433|NCT03040999|Biological|Pembrolizumab|Administered as an intravenous (IV) infusion every 3 weeks (Q3W)
15979434|NCT03040999|Drug|Placebo|Normal saline or dextrose solution administered as an IV infusion Q3W
15979435|NCT03040999|Drug|Cisplatin|100 mg/m^2 administered as an IV infusion Q3W
15979436|NCT03040999|Radiation|Accelerated Fractionation (AFX) Radiotherapy|70 Gray (Gy) given in 35 fractions over 6 weeks
15979437|NCT03040999|Radiation|Standard Fractionation (SFX) Radiotherapy|70 Gy given in 35 fractions over 7 weeks
15979438|NCT03040986|Other|Laboratory Biomarker Analysis|Correlative studies
15979439|NCT03040986|Drug|Selumetinib Sulfate|Given by mouth (PO)
15979445|NCT03040934|Device|XIENCE Everolimus-Eluting Coronary Stent System|98 subjects will be enrolled to receive a control device of XIENCE Everolimus-Eluting Coronary Stent System
15979446|NCT03040921|Procedure|Uterine transposition.|Surgical transposition of the uterus to the upper abdomen. After the end of radiotherapy, rectosigmoidectomy is performed and the uterus is repositioned into the pelvis.
15979447|NCT03040895|Other|Group-based ICDP-intervention|Group-based ICDP-intervention for caregivers through a sequence of eight meetings
15979448|NCT03040895|Other|Treatment as usual|Treatment as usual through the data collection period (6 months)
15979449|NCT03040882|Other|cotton sock|Application of a cotton sock in the immediate postoperative period before applied the Walker
15979450|NCT03040882|Other|Elastic Compression Wraps|Application of an Elastic Compression Wraps in the lower limb in the immediate postoperative period before applied the Walker (standard care)
15979451|NCT03040856|Dietary Supplement|Alpha Linolenic Acid|Alpha Linolenic Acid enriched diet
15979452|NCT03040856|Dietary Supplement|Omega 3 enriched diet ( DHA+EPA)|Omega 3 (DHA+EPA) supplementation enriched diet
15979453|NCT03040856|Other|Placebo|Placebo capsules containing olive oil
15979454|NCT03040830|Drug|Progesterone 100 IM/day|Progesterone IM 100 mg /day was started on day of egg retrieval in egg retrieval arm and on day of embryo transfer in the embryo transfer arm
15979455|NCT03040817|Procedure|Gastric peroral endoscopic pyloromyotomy (G-POEM)|"G-POEM procedure:
~A. Premixed methylene blue/normal saline were injected into gastric antrum submucosa at greater curvature, 5 cm proximal to the pylorus.
~B. Submucosal tunnel was created via endoscopic submucosal dissection. C. A white thick pyloric band, was in contrast to a thin-walled submucosal space of the duodenum observed distally.
~D. Pyloromyotomy starts with dissection of the pyloric ring exposing muscular layer underneath.
~E. Circular and longitudinal myotomy for 2-3 cm. F. Serosa indicates appropriate depth of myotomy. G. Reevaluation of the mucosotomy site. H. Mucosal entry was closed with clips from distal mucosal incision point."
15979456|NCT03040817|Drug|Esomeprazole + Mosapride|Each participant receive Esomeprazole （Nexium） 40mg bid + Mosapride （Mosapride Citrate Tablets） 5mg tid.
15979458|NCT03040791|Drug|Nivolumab|Nivolumab
15979459|NCT03040778|Drug|Pentoxifylline|Pentoxifylline is a commonly used medication for muscle pain associated with peripheral artery disease. It is a methylated xanthine derivative that improves peripheral blood flow, flexibility of red blood cell membranes, microcirculation, and tissue oxygenation and reduces viscosity of blood.
15979460|NCT03040778|Drug|Placebo|Placebo tablets
15979461|NCT03040778|Drug|Tocopherol|Tocopherol (vitamin E) impairs tissue fibrosis and is a potent oxygen radical scavenger that may reduce damage caused by free radicals impacting necrosis.
15979462|NCT03040765|Drug|Denosumab 60 MG/ML Prefilled Syringe|Denosumab 60 MG/ML will be administered to 20 patients with b-thalassemia major
15979463|NCT03040765|Drug|Zoledronic Acid 5Mg/Bag 100Ml Inj|Zoledronic Acid 5Mg/Bag 100Ml Inj will be administered to 20 patients with b-thalassemia major
15979464|NCT03040752|Drug|Nifedipine 20 Mg|nifedipine 20 mg tablets (Epilat Retard®, EIPICO, Egypt) twice daily, starting 12 hours after arrest of threatened preterm labor
15979465|NCT03040752|Drug|Ritodrine Oral Tablet|Ritodrine 5 mg tablets (Yutopar®, PHARCO, Alexandria) every 6 hours, starting 12 hours after arrest of threatened preterm labor
15979466|NCT03040739|Other|use of O'ARM imaging system|use of O'ARM imaging system
15979467|NCT03040726|Drug|Netupitant|Given PO
15979468|NCT03040726|Drug|Palonosetron|Given PO
15979469|NCT03040726|Drug|Palonosetron Hydrochloride|Given PO
15979470|NCT03040726|Other|Placebo|Given PO
15979471|NCT03040726|Other|Questionnaire Administration|Ancillary studies
15979472|NCT03040713|Drug|Flortaucipir F18|370 megabecquerel (MBq)(10 millicurie [mCi]) injection, single dose
15979473|NCT03040713|Procedure|Brain PET scan|positron emission tomography (PET) scan of the brain
15979474|NCT03040700|Other|Myocardial Perfusion Scan|Myocardial perfusion scan will be performed at rest and during pharmacological stress with dipyridamole (99mTc-Sestamibi)
15979475|NCT03040700|Other|Coronary CTA|Coronary CTA will be performed using a 320-detector scanner, 0.5 mm slice thickness, with gantry rotation of 350ms. Prior to each scan, the patient's blood pressure and heart rate will be assessed, and if the heart rate is above 70bpm, beta-blockers will be given orally. Following oral beta blocker administration, if the heart rate is still greater than 64bpm, intravenous metoprolol will be administered. A total of 70-100 mL of iodinated contrast will be administered via an automated injector at a rate of 5mL/s. All coronary CTA images will be transferred to a workstation (Vitrea FX-Vital Image) and analyzed by two experienced cardiac imagers who are blinded to all other data using a standard 18-segment coronary tree model.
15979476|NCT03040687|Biological|Anti CS6 BSIgG product (Lot PD1601105CS)|
15979477|NCT03040687|Biological|Anti B7A BSIgG product (Lot PD1601132ET)|
15979478|NCT03040687|Biological|Bovine Immunoglobin Negative Control (Lot PD161071NC)|
15979479|NCT03040687|Biological|B7A- CS6-expressing ETEC challenge strain|
15979480|NCT03040674|Procedure|Cell therapy|Each participant will receive cell therapy with stem cells harvested either from peripheral blood or from bone marrow plus peripheral blood; after harvest, cells are processed and returned to the patient via peripheral circulation on the same day
15979481|NCT03040661|Procedure|Ablation for atrial fibrillation.|Ablation for atrial fibrillation.
15979482|NCT03040648|Device|DSA|DSA was used for detection of intravascular injection
15979483|NCT03040648|Device|RTF|RTF was used for detection of intravascular injection
15979484|NCT03040635|Drug|Risdiplam|Single oral doses of Risdiplam will be administered on Day 1.
15979485|NCT03040635|Drug|Placebo|Single oral doses of Risdiplam matching placebo will be administered on Day 1.
15979486|NCT03040622|Device|WATCHMAN Left Atrial Appendage Closure|WATCHMAN Left Atrial Appendage Closure
15979487|NCT03040609|Behavioral|Visual-behavioral Scale at day 1|To perform the classification with the scale by caregiver.
15979488|NCT03040609|Behavioral|Test-retest at the end of 2 weeks|To perform the classification with the scale by orthoptist at the end of 2 weeks
15979491|NCT03040596|Behavioral|Standard voice therapy|Standard voice therapy sessions
15979492|NCT03040583|Other|No intervention|Patients data will be collected during their disease follow-up
15979493|NCT03040570|Procedure|Conservative oxygenation target|Participants allocated to the conservative oxygenation target group will receive supplemental oxygen and ventilator settings at the discretion of the treating clinical team with the aim of peripheral oxygen saturations remaining 88-92% (inclusive).
15979494|NCT03040570|Procedure|Liberal oxygenation target|Participants allocated to the liberal oxygenation target group will receive supplemental oxygen and ventilator settings at the discretion of the treating clinical team with the aim of peripheral oxygen saturations remaining >94%.
15979495|NCT03040557|Device|Flexible footwear|- Arm Flexible footwear: The intervention will be with flexible shoes in women with plantar fasciitis (acute and chronic) and will have a duration will be six months, for six hours a day, seven days a week (42 hours / week).
15979496|NCT03040557|Device|Orthopedic insole|- Arm Orthopedic insole: The intervention will be with orthopedic insole in women with plantar fasciitis (acute and chronic) and will have a duration will be six months, for six hours a day, seven days a week (42 hours / week).
15979497|NCT03040544|Procedure|LTB-Curriculum|The Lübeck Toolbox (LTB) curriculum has a structured training program, in which the laparoscopic basic skills are to be learned in six consecutive exercises. In doing so, the curriculum has precise targets for each of the six exercises based on the abilities of 15 MIS experts as a benchmark. The LTB curriculum is thus a structured training program with clear objectives that enable the technical learning of MIS basic skills comparable to the expert level.
15979498|NCT03040544|Procedure|Laparoscopic cholecystectomy|Performing Laparoscopic cholecystectomy by surgical residents without previous experience in MIS
15979499|NCT03040531|Dietary Supplement|Genistein aglycone|27mg bid in tablets
15979500|NCT03040531|Drug|Alendronate Oral Tablet|70 mg/week in tablets
15979501|NCT03040531|Dietary Supplement|Calcium + vitamin D3 tablet|500mg Calcium + 200 IU Vitamin D3 bid in tablets
15979502|NCT03040518|Behavioral|Narrative SMS|Narrative SMS have been defined as interactive life stories based around a range of characters (varying in age and socio-demographics) which can simulate the processes that make group-based interventions successful: humour, banter, peer support, facts about diet and PA and evidence based BCTs. The narrative form draws on real world learning from the film, television and games industry. When theorised, the narrative enables engagement with characters who convey the message of the intervention, and facilitate the viewer's empathy. Through creating an empathic bond with the character, users pay more attention to and become engaged and immersed within the story. This appears to lead to optimal learning and conceptualisation of the target information.
15979503|NCT03040518|Behavioral|Endowment Incentive|All participants will be 'endowed' with an incentive at the start of the trial. It will be placed into a hypothetical personal account which is theirs for a year (no withdrawals). Participants will be able to secure money for verified weight loss at 3, 6, and 12 months.
15979504|NCT03040505|Other|questionnary|Participant's verbalization will be audio recorded and then transcribed by investigators. The investigators will use predefined categories to score the strategies mentioned by participants during the think aloud task.
15979505|NCT03040479|Drug|lasmiditan 200 mg|single dose
15979506|NCT03040466|Device|reusable fiberoptic ureteroscope|We will use reusable fiberoptic ureteroscopes for the treatment of kidney and ureter stones.
15979507|NCT03040466|Device|disposable digital ureteroscope|We will use disposable digital ureteroscopes for the treatment of kidney and ureter stones.
15979508|NCT03040453|Device|Microwave ablation|
15979509|NCT03040453|Device|Irreversible electroporation|
15979510|NCT03040440|Device|Cylindrical endotracheal tube|Cylindrical endotracheal tube was intubated
15979511|NCT03040440|Device|TaperGaurd endotracheal tube|TaperGaurd endotracheal tube was intubated
15979512|NCT03040427|Drug|F-18 florbetapir|Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid).
15979513|NCT03040414|Device|MedtronicMinimed 670G 3.0 hybrid closed loop system|The components of the intervention are the insulin pump with insulin delivery algorithm (PID).
15979514|NCT03040414|Device|Medtronic Minimed 670G 4.0 AHCL with Guardian Sensor (3) continuous glucose monitoring sensor.|The components of the intervention are the insulin pump with insulin delivery algorithm (PID + Fuzzy Logic) and Guardian Sensor (3).
15979515|NCT03040401|Drug|Cohort 1, Ceplene® and Proleukin®|"Patients in Cohort 1 will be administered only Ceplene® during the first treatment cycles and Ceplene® in combination with Proleukin® during treatment cycles 2-4.
~IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2."
15979516|NCT03040401|Drug|Cohort 2, Ceplene® and Proleukin®|"Patients in Cohort 2 will be administered Ceplene® in combination with Proleukin® during all treatment cycles 1-4.
~IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2."
15979517|NCT03040401|Drug|Cohort 3, Ceplene® and Proleukin®|"Cohort 3 will receive either only Ceplene® during treatment cycles 1-4 or Ceplene® in combination with Proleukin® during treatment cycles 1-4. Treatment will be decided by the study committee based on the safety profile of treatment administered to cohort 1 and 2.
~IL-2 will be administered s.c., 1 µg/kg (=16400 IU/kg) body weight twice daily (BID) during treatment periods. Ceplene® will be administered s.c. 0.5 mg BID after IL-2."
15979518|NCT03040375|Behavioral|Peer counselling|
15979519|NCT03040362|Drug|[14C]-lasmiditan|[14C]-lasmiditan as a 200 mg (approximately 100 µCi) oral solution
15979520|NCT03040349|Behavioral|Training|The training program consists of a one-day core session addressing tobacco use with patients in the context of a busy primary care practice setting.The curriculum design was designed to be 2/3 theory and 1/3 practical. The program employs teaching techniques including role-play and case-study approaches known to enhance practice change.
15979595|NCT03039751|Drug|AdvVEGF-D|AdvVEGF-D will be injected into 10 sites of the myocardium
15979596|NCT03039751|Drug|Control Rx|Placebo (buffer solution without gene) will be injected into 10 sites of the myocardium
15979597|NCT03039738|Device|Vital Sync IM & VPMP (Surveillance Monitoring)|The Vital Sync™ Informatics Manager (IM) & Virtual Patient Monitoring Platform (VPMP) is an electronic medical record connectivity and remote continuous patient monitoring software solution.
15979521|NCT03040349|Behavioral|Provider and Patient Tools|Provider and patient tools were translated and adapted for use in primary care settings in Greece. A tool kit of resources will be distributed to providers which includes: patient tobacco use survey; provider consult form; provider medication reference sheet; patient quit plan booklet; and, waiting room posters. The provider consult form uses a checklist style set-up and provides real-time reminders for conducting an initial smoking cessation visit and follow-up appointments. The TiTAN Crete tools are available online at www.titan.uoc.gr
15979522|NCT03040349|Behavioral|E-blast and Webinars|In order to develop the network and continue to provide training opportunities for skills development we will develop a communication platform via an email list-serv to proactively communicate with providers who participate in the TiTAN program. A quarterly e-blast will be sent to all health care professionals involved in the TiTAN program. The e-blast will address the latest evidence-base practice, and skill development. Links to videos will also be provided. A webinar series will be scheduled to cover topics identified as interest by the primary health care providers. The webinar series will also be linked the Global Bridges EPACTT project.
15979523|NCT03040336|Behavioral|Prehabilitation|The 6-week long prehabilitation intervention will include (1) strength and balance training; (2) inspiratory muscle training; and (3) nutritional coaching and supplementation.
15979524|NCT03040323|Drug|Lumason 60.7Mg Powder for Injection|Lumason 60.7Mg Powder for Injection injected prior to ultrasound-guided biopsy
15979525|NCT03040323|Drug|Placebos|Placebos injected prior to ultrasound-guided biopsy
15979526|NCT03040310|Other|Back Rx program|The Back Rx program can be viewed via a smartphone app.
15979527|NCT03040297|Device|Tracheal gas insufflation 6 L/min|Endotracheal flow (6 L/min) of respiratory gases with standard FiO2
15979528|NCT03040297|Device|Tracheal gas insufflation 11 L/min|Endotracheal flow (11 L/min) of respiratory gases with standard FiO2
15979529|NCT03040297|Device|Tracheal gas insufflation catheter, without gas flow|Tracheal gas insufflation catheter, without gas flow
15979530|NCT03040284|Device|Echodia® hand-held equipment (ELIOS)|
15979531|NCT03040271|Other|Health-E-PALS-|Intervention to promote Healthy Eating and Physical Activity in Lebanese School-Children It comprises in class-activities, meetings with parents, improvement of school food service
15979532|NCT03040258|Other|Health-E-PALS-Pilot|Intervention to promote Healthy Eating and Physical Activity in Lebanese School-Children It comprises in class-activities, meetings with parents, improvement of school food service
15979533|NCT03040245|Behavioral|Whiplash book|
15979534|NCT03040232|Other|biomechanical assessment|biomechanical and strength assessment of both groups
15979535|NCT03040219|Drug|Folic Acid|Tablets
15979536|NCT03040193|Drug|Lignocaine Nebulization|4% Lignocaine delivered via Nebulization
15979537|NCT03040193|Drug|Saline Nebulization|Normal Saline Delivered via Nebulization
15979538|NCT03040180|Drug|Electrochemotherapy with bleomycin|Systemic injection, once only treatment
15979539|NCT03040180|Device|EndoVE|Electroporation using an endoscopic electroporation device
15979540|NCT03040167|Procedure|PEC 1 block|Under echoguidance, injection of the substance of interest between the major and minor pectoral muscles.
15979541|NCT03040167|Drug|Bupivacaine with epinephrine|Treatment group
15979542|NCT03040167|Drug|Normal saline|Placebo group
15979543|NCT03040154|Other|"Video Documentary entitled, Para Sa Kinabukasan ng Mga Anak (For Our Children's Future)"|
15979544|NCT03040154|Other|Usual Care Video that is publicly available|
15979545|NCT03040141|Drug|Low dose of VIS410|Single intravenous infusion of fixed low dose of VIS410 in addition to oseltamivir
15979546|NCT03040141|Drug|High dose of VIS410|Single intravenous infusion of fixed high dose of VIS410 in addition to oseltamivir
15979547|NCT03040141|Drug|Placebo|Single intravenous infusion of placebo in addition to oseltamivir
15979548|NCT03040128|Drug|Minocycline|high-dose, intravenous minocycline
15979549|NCT03040128|Other|normal saline infusion|
15979550|NCT03040115|Other|Non-Interventional Study|
15979551|NCT03040102|Other|Hospice Video Educational Tool|it's a 6 minute video regarding hospice care
15979552|NCT03040102|Other|Standard of Care|Standard of Care practice is used
15979553|NCT03040089|Device|PICO+4|picosecond, neodymium-doped yttrium aluminum garnet laser
15979554|NCT03040089|Drug|Neoquine Cream 2%|2% hydroquinone cream
15979555|NCT03040076|Behavioral|Cognitive Bias Treatment|Two computerized tasks will be administered during four intervention sessions. During the first task, the Word Sentence Association Paradigm, participants see a threat or benign word and then an ambiguous sentence. Participants press one if they believe the word and sentence are related and two if they believe the word and sentence are not related. Participants are given feedback that they responded correctly if they state that a benign word is related to the sentence or they state that a threat word is not related to the sentence. The second task is the Ambiguous Scenarios Task. In each trial, an ambiguous scenario, ending in a benign word, appears on the screen. After the scenario is presented, participants respond to a comprehension question and are given feedback on their performance.
15979556|NCT03040076|Behavioral|Relaxation Condition|Participants assigned to the active control group will complete four sessions of progressive muscle relaxation training. Two alternating relaxation scripts will be used. The scripts will be presented as Youtube videos with a blank black screen and will instruct participants to keep their eyes closed for the duration of the training. Participants will access the videos through Qualtrics to ensure that data can be gathered about their compliance. The relaxation scripts used in the present study will be modified versions of those currently being tested by other researchers utilizing cognitive bias modification paradigms. The relaxation training sessions will be matched to the length of the treatment condition and therefore will last approximately 30 minutes.
15979557|NCT03040063|Procedure|Combined endovascular approach (EVAR)|"puncture of SFA in orthograde position if possible
~DSA through 4F dilator, proof of occlusion
~wire test
~Heparin 70-80 IU/kg i.a.
~implantation of peripheral stent graft VIABAHN
~implantation of peripheral stent SUPERA into stent graft
~insertion of strait flush catheter for local thrombolysis
~administration of continuous local thrombolysis in the dose of 1 mg/hr., unfractionated heparin continuously (APTT 1,5-2x) according to the department standards
~control angiography in 12 hrs or earlier according to clinical status and symptoms
~repeated angiography in 24 hrs"
15979598|NCT03039738|Device|Telemetry Monitoring|Continuous ECG monitoring for hospitalized patients at-risk for cardiac events.
15979558|NCT03040063|Procedure|Standard optimal therapy (OPT)|"puncture of SFA in orthograde position if possible
~DSA through 4F dilator, proof of occlusion
~wire test
~Unfractionated heparin 70-80 IU/kg i.a.
~insertion of strait flush catheter for local thrombolysis
~administration of continuous local thrombolysis in the dose of 1 mg/hr., unfractionated heparin continuously (APTTT 1,5-2x)
~control angiography in 12 hrs or according to clinical status and symptoms
~repeated angiography in24 hrs
~Final result review, vascular team consultation and indication for surgical or conservative management of popliteal artery aneurysm."
15979559|NCT03040050|Other|rPCR results|Interventional group: rPCR results will be shared with the clinical provider to determine appropriate standard of care antibiotic treatment at time of standard of care prostate biopsy.
15979560|NCT03040050|Other|Control group|Control group: rPCR results will not be shared with the clinical provider at time of standard of care prostate biopsy. Standard of care antibiotic selection will be up to the discretion of the clinical provider.
15979561|NCT03040024|Drug|Ketamine|Ketamine will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.
15979562|NCT03040024|Drug|Placebo|Placebo will be administered intravenously after administration of general anesthesia and prior to the first surgical incision.
15979563|NCT03040024|Device|Electroencephalogram (EEG)|A processed EEG device will be used during the surgical procedure to gather raw EEG data for off line analysis among patients developing post-operative delirium.
15979564|NCT03040011|Drug|Dexamethasone|Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.
15979565|NCT03040011|Drug|Bupivacaine|Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.
15979566|NCT03040011|Procedure|Bilateral Pudendal Nerve Block|Performed transvaginally. The ischial spines will be palpated transvaginally and the sacrospinous ligament identified as a firm band running medially and posteriorly from the ischial spine to the sacrum. The needle guide will be inserted and positioned against the vaginal mucosa on the sacrospinous ligament approximately 1 cm medial and inferior to the ischial spine. When the needle guide is properly positioned, the spinal needle is advanced approximately 1cm through the vaginal mucosa into the sacrospinous ligament. The needle will be aspirated to ensure no intravascular needle placement. With a negative aspirate, 5 milliliters of solution are injected. This same procedure will be performed on the contralateral side.
15979567|NCT03040011|Procedure|Bilateral Levator Ani Muscle Injection|Performed transperineally. With thumb, superomedial aspect of obturator foramen is palpated 2-3 cm lateral to the clitoris. The index and middle finger are in the vagina to confirm obturator foramen. A spinal needle is inserted through the the obturator foramen into the obturator internus muscle. The needle is angled slightly posteriorly towards the ischial spine, parallel to the arcus tendineus levator ani and arcus tendineus fascia pelvis. The needle is advanced to the level of the ischial spine, the vaginal hand ensuring that the needle has not perforated the vaginal wall. Once the needle tip is at a depth of the ischial spine, aspiration is performed to ensure no intravascular needle placement. 5 milliliters of solution is injected along the length of the needle tract.
15979568|NCT03040011|Drug|Saline|Pudendal Nerve and Levator Muscle Injection. See additional information in study arm description.
15979569|NCT03039985|Device|Zirconia crowns (Prettau®)|Monolithic zirconia molar crowns are, after randomization, placed in patients with or without bruxism
15979570|NCT03039985|Device|lithium disilicate crowns (IPSe.max®)|lithium disilicate molar crowns are, after randomization, placed in patients with or without bruxism
15979571|NCT03039972|Diagnostic Test|No intervention|No intervention
15979572|NCT03039959|Diagnostic Test|No intervention|No intervention
15979573|NCT03039946|Device|Closed-Loop GDFT|Patients receive fluids in the form of 100ml boluses of crystalloid (Plasmalyte) over 6 minutes via an automated closed-loop goal-directed fluid therapy (GDFT) system guided by non-invasive flow monitoring (Clearsight system). Additional boluses of colloid or crystalloid can be administered under the attending anesthesiologist's discretion (e.g. to compensate blood loss) .
15979574|NCT03039946|Other|Restrictive Fluid Therapy|Patients receive fluids (Plasmalyte) via a restrictive approach with a baseline of of 4ml/kg/h. Additional boluses of colloid or crystalloid can be administered under the attending anesthesiologist's discretion (e.g. to compensate blood loss) .
15979575|NCT03039933|Behavioral|Fear of Hypoglycemia|Participants will receive exposure and response prevention and/or hypoglycemia awareness training.
15979576|NCT03039933|Other|Treatment As Usual|Treatment As Usual
15979577|NCT03039920|Other|Electronic cigarette|Smoking of electronic cigarette
15979578|NCT03039920|Other|Conventional cigarette|Smoking tobacco cigarette
15979579|NCT03039907|Procedure|Total Knee Arthroplasty|Total knee arthroplasty
15979580|NCT03039894|Other|Gradebook Game|Students in the intervention group will spend time meeting as teams to review their scorecards, and do team-building activities, all of which will occur during non-content periods at school (Advisory and Enrichment).
15979581|NCT03039881|Device|Non-Invasive Respiratory Volume Monitor|The device requires the application of a monitoring PadSets to the patient's skin similar to EKG electrodes and, as such, poses minimal risk.
15979582|NCT03039855|Device|TIARA valve and transapical delivery system|Transcatheter mitral valve replacement
15979583|NCT03039842|Drug|Dextromethorphan|
15979584|NCT03039842|Drug|Memantine|
15979585|NCT03039842|Drug|dextromethorphan+memantine|
15979586|NCT03039842|Drug|placebo+valproate|
15979587|NCT03039829|Dietary Supplement|Creatine nitrate, low dose|Creatine nitrate at 3.0 grams (2.0 grams creatine, 1.0 gram nitrate, 3.0 grams dextrose)
15979588|NCT03039829|Dietary Supplement|Creatine nitrate, high dose|Creatine nitrate at 6.0 grams (4.0 grams creatine, 2.0 grams nitrate)
15979589|NCT03039829|Dietary Supplement|Placebo|Placebo at 6.0 grams (6.0 grams dextrose)
15979590|NCT03039816|Device|Nasaleze|Nasaleze cellulose powder
15979591|NCT03039816|Device|Placebo|Lactose powder in the same plastic container as Nasaleze and with the same taste
15979592|NCT03039803|Procedure|uterine closure during cesarean section|
15979593|NCT03039790|Biological|NoV Vaccine|No NoV vaccine injection administered.
15979594|NCT03039764|Device|Rapael|This group will receive virtual reality-based rehabilitation intervention wearing Rapael glove made by Neofect supplemented with standard occupational services per conventional protocols.
15979599|NCT03039725|Other|Observational|Retrospective chart review on vaccine compliance
15979600|NCT03039699|Drug|Ergoferon|
15979601|NCT03039699|Drug|Placebo|
15979602|NCT03039686|Drug|RO7239361|Take RO7239361 subcutaneously on specified days over a 48 week blinded period
15979603|NCT03039686|Drug|Placebo for RO7239361|Take placebo subcutaneously on specified days over a 48 week blinded period
15979604|NCT03039673|Drug|Riluzole|"All patients will be treated with Riluzole for a period of three months prior to final inclusion and randomization. Riluzole treatment will continue throughout the 18 months of follow-up planned for in this protocol.
~Riluzole treatment is part of routine care for patients with ALS."
15979605|NCT03039673|Drug|IL-2|"The dose of IL-2 to be used in this study will be 2.0 million IU/day.
~Each treatment course will last 5 days (i.e. 1 sub-cutaneous injection per day for 5 consecutive days). The 5-day course will be repeated every 4-weeks over an 18-month treatment period.
~In case of intolerance, a flexible dose-reduction schedule is available."
15979606|NCT03039673|Drug|5% glucose water solution|"The placebo consists of 5% glucose water solution, which is the matrix with which low-dose IL-2 injections are prepared in the experimental arm. Placebo injections are prepared in exactly the same manner as IL-2 injections, just without the IL-2.
~Each treatment course will last 5 days (i.e. 1 sub-cutaneous injection per day for 5 consecutive days). The 5-day course will be repeated every 4-weeks over an 18-month treatment period."
15979607|NCT03039660|Behavioral|RefreshMD|Online Sleep Improvement Course
15979608|NCT03039660|Behavioral|Bond Between Us|Online Educational Course
15979609|NCT03039621|Drug|Ergoferon|For oral use.
15979610|NCT03039621|Drug|Placebo|For oral use.
15979611|NCT03039608|Drug|combination of local steroid injection（triamcinolone ）with oral steroid administration（prednisone）|local steroid injection and oral steroid
15979612|NCT03039608|Drug|oral steroid administration（prednisone）|oral steroid
15979613|NCT03039595|Other|Ploidy and tumour:stromal ratio measurements|Ploidy and tumour:stromal ratio measurements will be made on specimens of early rectal cancer removed by transanal endoscopic microsurgery (TEM)
15979614|NCT03039582|Diagnostic Test|Bidigital palpation|palpation of the anovaginal distance with two fingers
15979615|NCT03039582|Diagnostic Test|Perineal ultrasound|ultrasound measurement of the anovaginal distance
15979616|NCT03039569|Behavioral|Text messaging|"The messages will consist of information on how to increase fruits and vegetables and reduce high-fat and sugary foods intake, increase the availability of fruits and vegetables and reduce high-fat and sugary foods in the home, strategies to increase diabetes self-management skills, and awareness of cardiovascular disease risk perception and knowledge. The text messages will be derived from the American Association of Diabetes Educator (AADE) handouts (Reducing Risks, Monitoring, Healthy Coping, Problem Solving, Taking Medication, Healthy Eating, and Exercise). The control group will not receive text messages"
15979617|NCT03039556|Behavioral|Normal Daily Steps|Complete normal daily ambulation for one week
15979618|NCT03039556|Behavioral|Step-Reduction|Reduce daily ambulation to fewer than 1000 steps per day for two weeks
15979619|NCT03039556|Behavioral|Return to Normal Daily Steps|Increase daily ambulation to 100% of normal daily step-count for two weeks
15979620|NCT03039543|Drug|Rocuronium|Intravenous rocuronium was used to maintain moderate (TOF count of 1 or 2) neuromuscular blockade for patients with moderate neuromuscular blockade whereas intravenous rocuronium was used to maintain deep (TOF count of 0 with post-tetanic count of 2) neuromuscular blockade for patients with deep neuromuscular blockade.
15979621|NCT03039543|Drug|Sugammadex|Patients in moderate neuromuscular blockade are reversed with 2 mg/kg sugammadex at a TOF count of 1 or 2 and patients in the deep neuromuscular blockade are reversed with 4 mg/kg sugammadex at post-tetanic count of 2.
15979622|NCT03039530|Behavioral|Group Cognitive Behavioral Therapy|9 weekly 2-hour group CBT sessions delivered by 2 trained Public Health Nurses.
15979623|NCT03039530|Behavioral|Postnatal Care As Usual|Postnatal care as usual will involve treatment from their family physician and midwife or obstetrician, and voluntary participation in programs offered by Niagara Region Public Health and in the community.
15979624|NCT03039517|Device|ACTitouch|The device is applied to the lower leg (calf, ankle, and foot) and consists of an under-sock worn against the skin, a compression sleeve containing 4 inflatable chambers and a controller unit. The controller provides the airflow to inflate the chambers and monitors and adjusts the chamber pressure to maintain the intended treatment pressures.
15979625|NCT03039517|Device|Compression garments (stockings)|"Compression garments (stockings) now serve as the generally recommended standard of care for patients post DVT and will be utilized as the control compression method in this study. Compression garments utilized in this study will be below the knee style with a pressure range of 30-40 mmHg. If a patient does not have compression garments as indicated, these stockings will be provided."
15979626|NCT03039504|Dietary Supplement|Potensa, a succinate-based dietary supplement|Potensa - a dietary supplement: 4 capsules (2 white 200mg each and 2 blue 200 mg each) once a day with a meal or immediately after a meal, preferably after breakfast, for 3 months.
15979627|NCT03039504|Dietary Supplement|Placebo|Placebo: 4 capsules (2 white 200mg each and 2 blue 200 mg each) once a day with a meal or immediately after a meal, preferably after breakfast, for 3 months.
15979628|NCT03039491|Biological|Pneumococcal polysaccharide vaccine 23 valent|This is the pneumococcal vaccine consisting of the capsular polysaccharides of 23 serotypes of Streptococcus pneumoniae
15979629|NCT03039491|Biological|13 valent conjugated pneumococcal vaccine|This is the pneumococcal vaccine consisting of the capsular polysaccharides of 13 serotypes of Streptococcus pneumoniae conjugated to non-toxic diphtheria carrier protein 197
15979630|NCT03039478|Dietary Supplement|Xylitol 7g|Xylitol 7g in 300mL tap water
15979631|NCT03039478|Dietary Supplement|Erythritol 10g|Erythritol 10g in 300mL tap water
15979632|NCT03039478|Dietary Supplement|Xylitol 17g|Xylitol 17g in 300mL tap water
15979633|NCT03039478|Dietary Supplement|Xylitol 35g|Xylitol 35g in 300mL tap water
15979634|NCT03039478|Dietary Supplement|Erythritol 25g|Erythritol 25g in 300mL tap water
15979635|NCT03039478|Dietary Supplement|Erythritol 50g|Erythritol 50g in 300mL tap water
15979716|NCT03038854|Other|Test GUM|Growing up milks (GUMs) are milk-based drinks with vitamins and minerals for toddlers and pre-school children.
15981123|NCT03028467|Drug|Methotrexate|Methotrexate capsule/tablet 8-16 mg per week is given orally.
15979636|NCT03039465|Device|Modified Trans-Esophageal Prosthesis|This device is a biomedical grade silicon voice prosthesis with an inner esophageal flange, a stem and an outer tracheal flange. Insertion would be done through a modified 'romovac' inserter set / curved metal inserter (provided with the TEP) and an oesophagoscope in case of secondary insertion would be used. in patients with existing TEP puncture / who require a TEP change, on out-patient basis, the insertion would be done with a novel two-part inserter device (front loading)
15979637|NCT03039452|Behavioral|High intensity interval training|Each training session will consist of a 3-5 minute warm-up, followed by 10 repetitions of 1-minute bouts at individualized training intensity with 1-minute rest periods.
15979638|NCT03039439|Procedure|Biospecimen Collection|Previously collected tumor tissue and blood samples
15979639|NCT03039439|Other|Laboratory Biomarker Analysis|Correlative studies
15979640|NCT03039426|Drug|Bupivacaine|0.5% bupivacaine 20ml divided in two; 10 ml intraperitoneal infiltration and 10 ml subcutaneous infiltration
15979641|NCT03039426|Drug|Diclofenac|diclofenac 75 mg intramuscular, 2 hours postoperation
15979642|NCT03039413|Drug|Copper Cu 64 TP3805|Given IV
15979643|NCT03039413|Procedure|Positron Emission Tomography|Undergo Cu-64-TP3805 Positron Emission Tomography scan
15979644|NCT03039413|Procedure|Computed Tomography|Undergo Cu-64-TP3805 Computed Tomography scan
15979645|NCT03039400|Behavioral|Physiotherapist-guided home exercise with web-based support|Those in the web-based physio group will access their exercise program online and will be able to leave messages for their physiotherapist on the platform. Physiotherapists will monitor usage and respond to messages every two weeks.
15979646|NCT03039400|Behavioral|Physiotherapist-guided home exercise with standard support|Those in the standard care group will receive a written, home-based exercise program. Participants in the usual care group will be asked to keep an exercise diary, in paper format.
15979647|NCT03039387|Device|anodal transcranial direct current stimulation|
15979648|NCT03039387|Device|transcranial direct current stimulation (sham)|for the placebo control condition, the transcranial direct current stimulation will only last for 30 seconds and will then be ramped down.
15979649|NCT03039374|Other|Magnetic resonance imaging|The extent of obstetric anal sphincter injury will be evaluated using MRI, endoanal ultrasound and anal manometry
15979650|NCT03039361|Behavioral|Equine Assisted Psychotherapy|Therapist will use Equine Assisted Growth and Learning Association (EAGALA) modeled Equine Assisted Psychotherapy.
15979651|NCT03039348|Other|semi-structured interview using a questionnaire|semi-structured interview using a questionnaire
15979652|NCT03039322|Diagnostic Test|Serum Golgi Protein 73|Serum test
15979653|NCT03039309|Procedure|Endoscopic Submucosal Dissection|Endoscopic submucosal dissection is an endoscopic resection technique that utilises an endoscopic knife to remove lesions within the gastrointestinal tract in an en bloc fashion.
15979654|NCT03039296|Procedure|Endoscopic rhizotomy|Endoscopic rhizotomy (facet joint denervation) is carried out through the insertion of an endoscope to the medial spinal nerve area with the help of mobile C-arm x-ray guidance. The tissue surrounding the medial nerves is endoscopically visualized and dissected with a sterile grasper to expose the nerve structure. Finally, a radiofrequency probe is used to ablate the problematic medial branch nerve under direct endoscopic control. The procedure is concluded with the removal of the endoscope and the small incision is closed with 1-2 skin sutures.
15979655|NCT03039283|Device|Nucleus CI532 cochlear implant|Retrospective study of the commercial CI532 cochlear implant
15979656|NCT03039270|Other|With sonic activation (SMART Device®)|The operator applied a desensitizing gel containing 5% potassium nitrate and 2% sodium fluoride (Desensibilize KF 2%, FGM, SC, Brazil) on the vestibular surfaces of the participant's anterior teeth. In the sonic activation side, immediately after the gel's application, sonic activation(Smart Sonic Device, FGM, SC, Brazil) was performed for 1.5 minutes in total for side (30 seconds per tooth). After the time of 30 seconds in each of the three anterior teeth of the respective side, the gel was removed from teeth with cotton. After removal of the desensitizing gel, gingival tissues were isolated and the bleaching gel were applied.
15979657|NCT03039270|Other|Control (Without sonic activation)|The operator applied a desensitizing gel containing 5% potassium nitrate and 2% sodium fluoride (Desensibilize KF 2%, FGM,SC, Brazil) on the vestibular surfaces of the participant's anterior teeth. In the side allocated for application without sonic activation, gel was kept for 10 minutes, after which it was removed from the teeth. After removal of the desensitizing gel, gingival tissues were isolated and the bleaching gel were applied.
15979658|NCT03039257|Dietary Supplement|Vitamin A|Dose administration will start with 2500 IU/kg with maximum dose of 250,000 IU orally.
15979659|NCT03039244|Other|Photodynamic therapy|After Scaling and root planing, periodontal pockets will receive the antimicrobial (aPDT) photodynamic therapy. Shortly phenothiazine hydrochloride photosensitizing is applied at a concentration of 10mg/mL from the pocket bottom to the gingival margin. After 1 minute, irrigation is performed from periodontal pockets with distilled water to remove excess dye. The stained area is then irradiated with a diode laser with 660 nm of wavelength and maximum power of 60 mW/cm², through a fiber-optic probe of 0.6 mm diameter. Exposure to radiation will occur at six sites per tooth under treatment, making the total time of 1 minute per element, or the equivalent of 10 seconds per site. The aPDT applications will be repeated in the same way until the second week in the days 2, 7 and 14.
15979660|NCT03039244|Other|Control Group|A sham procedure will be held simultaneously in pairs of contralateral teeth selected that will not receive the aPDT (control group).
15979661|NCT03039244|Device|Diode Laser|
15979662|NCT03039231|Device|Freespira Breathing System|Following authorization from a study team member, patient will be assigned an FBS to take home and perform 4 weeks of training exercises twice a day for 17 minutes each time. Efficacy of the FBS system will be evaluate over the 4 week period and at 2 and 6 month follow-up periods.
15979663|NCT03039218|Device|Dornier Aries 2|Extracorporeal Shock Wave Device for treatment of mild erectile dysfunction
15979664|NCT03039218|Device|Placebo / Sham|Inactive (placebo/sham) Extracorporeal Shock Wave Device for treatment of mild erectile dysfunction
15979665|NCT03039205|Drug|Clopidogrel|Clopidogrel 600 mg loading dose + 75 mg q.d. for 7 to 9 days
15979666|NCT03039205|Drug|Ticagrelor|Ticagrelor 180 mg loading dose + 90 mg b.i.d. for 7 to 9 days
15979667|NCT03039192|Drug|Esketamine|Intranasal esketamine solution 84 milligram (mg)
15979668|NCT03039192|Other|Placebo|Intranasal Placebo solution
15979669|NCT03039192|Other|Standard of Care|The standard of care antidepressant treatment (antidepressant monotherapy or antidepressant plus augmentation therapy) will be determined by the treating physician(s) based on clinical judgement and practice guidelines prior to randomization, and the treatment will be initiated on Day 1.
15979670|NCT03039179|Device|polyurethane foam dress|Application of the polyurethane foam dress at the heel in the immediate postoperative period before applied the Walker
15979671|NCT03039166|Device|MRI 7T|
15979672|NCT03039166|Device|MRI 3 T|
15979673|NCT03039166|Biological|blood sample|
15979674|NCT03039140|Other|Educational Intervention|Attend weekly educational sessions
15979675|NCT03039140|Behavioral|Exercise Intervention|Participate in CR program
15979676|NCT03039140|Other|Quality-of-Life Assessment|Ancillary studies
15979677|NCT03039140|Other|Questionnaire Administration|Ancillary studies
15979678|NCT03039127|Device|Immunostimulating Interstitial Laser Thermotherapy|Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a tumor specific immunologic response.
15979679|NCT03039114|Drug|Parsaclisib|Parsaclisib at the protocol-defined starting dose administered once daily for 8 weeks followed by once weekly.
15979680|NCT03039114|Drug|Hexal|Bendamustine 90 mg/m^2 administered intravenously at protocol-defined timepoints.
15979681|NCT03039114|Drug|Gazyvaro|Obinutuzumab 1000 mg by intravenous infusion at protocol-defined timepoints.
15979682|NCT03039101|Procedure|Nasal lavage|determine frequency of CD49d expressing neutrophils in the nasal lavage by flow cytometry
15979683|NCT03039101|Procedure|Nasal allergen challenge|A small amount of allergen extract will be applied to one naris.
15979684|NCT03039101|Procedure|Epicutaneous skin testing|Skin testing (prick) to determine allergies.
15979685|NCT03039101|Procedure|Peripheral blood|Peripheral blood draw
15979686|NCT03039101|Drug|Montelukast 10Mg Tablet|one pill orally, daily, for 1 week
15979687|NCT03039101|Drug|Placebo Oral Tablet|one pill orally, daily, for 1 week
15979688|NCT03039088|Other|Follow-up after 12 weeks after TNF alpha blockers initiation|
15979689|NCT03039075|Drug|Metformin SR Tablet|Metformin SR Tablet made in Conquer pharmaceutical co., LTD
15979690|NCT03039049|Drug|Triptorelin 0.1 mg|a single dose of Triptorelin 0.1 mg subcutaneously administered 6 days after oocyte retrieval.
15979691|NCT03039036|Procedure|Amniotomy|Artificially rupturing membranes
15979692|NCT03039036|Device|Foley Catheter|Foley catheter device is commonly used for cervical ripening during labor induction. It is used independently or in combination with pharmacologic augmentation. It is inserted in the cervix and the balloon is then inflated with 60 cc of saline. It is removed when either 1. it falls out under gentile traction during labor checks or 2. it is de-inflated at 12 hours after placement. If at the time of de-inflation at 12 hours, the desired affect has not been achieved, the provider may choose to place another foley balloon or use an alternative method of induction (misoprostol). This is an eligibility criteria and only patients who are undergoing induction with a Foley Catheter will be approached for enrollment.
15979693|NCT03039036|Drug|Misoprostol|Misoprostol is a medication that is commonly used for cervical ripening during labor induction. It is commonly used independently or in combination with mechanical methods, such as a foley catheter. The commonly used dose during term labor induction is 25 mcg. Use of this medication will be decided by the provider.
15979694|NCT03039023|Dietary Supplement|Choline Bitartrate|500mg choline bitartrate tablets
15979695|NCT03039023|Other|Pre-cooked, pre-peeled whole hardboiled eggs|Obtained from a commercial source.
15979696|NCT03039023|Other|Egg whites from pre-cooked, pre-peeled hardboiled eggs|Egg whites from pre-cooked, pre-peeled hardboiled eggs. The yolks are removed and discarded.
15979697|NCT03039023|Dietary Supplement|Phosphatidylcholine capsules|420 mg phosphatidylcholine capsules obtained from a commercial source.
15979698|NCT03038984|Behavioral|At Home Screening procedure On demand|Home monitoring is a supportive treatment. Patients are randomized to screen themselves on demand
15979699|NCT03038984|Behavioral|At Home Screening procedure every 3 months|Home monitoring is a supportive treatment. Patients are randomized to screen themselves every 3 months
15979700|NCT03038971|Biological|Dose Level 1|Short and Tall Ragweed Mix
15979701|NCT03038971|Biological|Dose Level 2|Short and Tall Ragweed Mix
15979702|NCT03038971|Biological|Placebo|Saline with 0.4% Phenol
15979703|NCT03038958|Drug|Isobaric 2-chloroprocaine|intrathecal injection of 50 mg isobaric 2-Chloroprocaine
15979704|NCT03038958|Drug|Hyperbaric prilocaine|intrathecal injection of 50 mg hyperbaric prilocaine 2%
15979705|NCT03038945|Other|2/0 barbed suture|Close vaginal vault 2 planes with 2/0 barbed suture in patients with total laparoscopic hysterectomy in benign pathology
15979706|NCT03038945|Other|0/0 Vicryl suture|Close vaginal vault 2 planes with 0/0 Vicryl suture in patients with total laparoscopic hysterectomy in benign pathology
15979707|NCT03038919|Drug|Testosterone cypionate|Bi-weekly intramuscular injection of testosterone cypionate 200mg.
15979708|NCT03038919|Other|Standard nutrition and physical therapy at ICU|follow-up of the patient without use of testosterone cypionate
15979709|NCT03038893|Diagnostic Test|Point Of Care Ultrasound (PODUS)|Patients were first submitted to Point Of Care Ultrasound (POCUS) and then to Echo Doppler Ultrasound (EDUS) for the diagnosis of DVT.
15979710|NCT03038893|Diagnostic Test|Echo Doppler Ultrasound (EDUS)|Patients were submitted only to Echo Doppler Ultrasound (EDUS) for the diagnosis of DVT.
15979711|NCT03038880|Drug|Faricimab|Faricimab was administered via IVT injections as specified during the treatment period.
15979712|NCT03038880|Drug|Ranibizumab|Ranibizumab was administered via IVT injections as specified during the treatment period.
15979713|NCT03038880|Drug|Sham Procedure|The sham was a procedure that mimicked an IVT injection and involved the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It was administered to participants in the faricimab treatments arms at applicable visits to maintain masking among treatment arms.
15979714|NCT03038867|Drug|Duloxetine|Duloxetine orally 60mg daily for 5 weeks, then taper to 30mg daily for 1 week
15979715|NCT03038867|Drug|Placebo|Placebo orally 2 tabs daily for 5 weeks, then taper to 1 tab daily for 1 week
15981129|NCT03028441|Biological|VRC-CHKVLP059-00-VP|Measles-vectored Chikungunya vaccine
15979717|NCT03038854|Other|Standard GUM|Growing up milks (GUMs) are milk-based drinks with vitamins and minerals for toddlers and pre-school children.
15979718|NCT03038854|Other|Cows' milk|Homogenized store-bought full fat cow's milk.
15979719|NCT03038841|Device|Mobile Health|Patients discharged from hospital will be equipped with a tracking bracelet and a smart phone
15979720|NCT03038828|Biological|Leukocyte Interleukin, Injection|Immunotherapy
15979721|NCT03038815|Device|VACOped|restriction of ankle joint motion
15979722|NCT03038815|Device|Ortho Tri|restriction of ankle joint motion
15979723|NCT03038802|Biological|Therapeutic hepatitis B vaccine|HBV vaccine based on unique combination of recombinant PreS hepatitis B surface antigen particles formulated with Advax-2 adjuvant
15979724|NCT03038802|Biological|Commercial Hepatitis B vaccine|Commercially available prophylactic hepatitis B vaccine formulated with alum adjuvant
15979725|NCT03038776|Biological|Recombinant influenza hemagglutinin|Avian H7N9 influenza vaccine
15979726|NCT03038763|Other|Eligibility Screening|Investigators will call eligible mothers to screen for the possibility that eligible mothers may have passed HCV on to adult children. Investigators will consent these mothers to contact the adult child(ren), as the child(ren) must be informed of the mother's HCV status, if not already known.
15979727|NCT03038763|Diagnostic Test|HCV test|Adult children will be invited to Penn or a Penn affiliate to have labwork, testing HCV antibody and HCV quant. If the quant comes back positive, investigators will also test genotype and fibrosure.
15979728|NCT03038750|Other|Eligibility and lifestyle restrictions check.|Eligibility will be assessed at each study visit and participants will be informed in advance of their visit.
15979729|NCT03038750|Other|Medical history, demographic and lifestyle factors|Medical History, participants demographics and lifestyle factors will be assessed by the participant completion of the medical history and ethnicity questionnaires.
15979730|NCT03038750|Other|Anthropometric measurements: height, weight, and body fat|Height measured by stadiometer. Weight and body fat measured by Tanita scale bioelectrical impedance analysis.
15979731|NCT03038750|Other|Blood pressure and heart rate|Parameters will be measured using a validated, automated device while seated and again after 3-5 min standing. All measurements will be done in triplicate.
15979732|NCT03038750|Other|Forearm blood flow: Visit 1 (EDNRA)|Intra-arterial infusion of Phenylephrine at doses of 0.75, 2.5, and 7.5 μg/min for 6 min each (18 min in total). FBF measured in the last 3 minutes. There will be a 30 minute washout with saline followed by Endothelin-1 infusion of at a dose of 5 pmol/min for 90 min.
15979733|NCT03038750|Other|Forearm blood flow: Visit 2 (EDNRA)|Intra-arterial infusion of Sodium nitroprusside infusion at doses of 1, 3, and 10 μg/min for 6 min each (18 min in total). FBF measured in the last 3 minutes. There will be a 20 minute washout with saline followed by infusion of BQ-123 at a dose of 10 nmol/min for 90 min.
15979734|NCT03038750|Other|Blood biochemistry (PNPLA3)|25ml blood will be taken from the participant in a glucose fasting state. Following a high carbohydrate meal, a second 25ml blood sample will be taken. Clinical Biochemistry tests and detailed lipid analysis will be performed.
15979735|NCT03038750|Other|Blood EPCR function (PROCR)|Blood sample taken will be analysed via ELISA and FACS.
15979736|NCT03038750|Other|Blood platelet coagulation and function (PROCR)|Blood sample taken will be analysed using a Platelet coagulation and function assay.
15979737|NCT03038750|Other|Blood endothelial permeability (PROCR)|Blood sample will be analysed in vitro using a permeability assay kit.
15979738|NCT03038750|Other|Blood leukocyte-endothelium adhesion (PROCR)|Blood sample will be analysed in vitro using a leukocyte-endothelium adhesion assay.
15979739|NCT03038750|Other|Baseline Venepuncture (PNPLA3, Visit 1)|Up to 25ml Blood will be taken.
15979740|NCT03038750|Other|Deuterium water - Loading dose 1 (PNPLA3, Visit 1)|Loading dose of 3 g/kg body water.
15979741|NCT03038750|Other|Deuterium water - Loading dose 2 (PNPLA3, Visit 1)|Loading dose of 3 g/kg body water.
15979742|NCT03038750|Other|Energy-balanced dinner (PNPLA3, Visit 1)|Provided following baseline bloods and loading dose 1.
15979743|NCT03038750|Other|Fasting venepuncture (PNPLA3, Visit 2)|Up to 25ml Blood will be taken.
15979744|NCT03038750|Other|Deuterium water - Maintenance dose (PNPLA3, Visit 2)|every hour, maintenance dose 0.04 g/kg body water
15979745|NCT03038750|Other|Consumption of high carbohydrate meal (PNPLA3, Visit 2)|Provided following fasting blood sample.
15979746|NCT03038750|Other|Postprandial Venepuncture (PNPLA3, Visit 2)|Up to 25ml Blood will be taken.
15979747|NCT03038750|Other|Venepuncture (PROCR)|Up to 50ml Blood will be taken.
15979748|NCT03038737|Other|bre.flex|"In the recent time thermoplastic materials become quite popular in clinical practice such as nylon and acetal resins. since the 1950, polyamide resin (nylons) provide improved esthetics and reduction of rotational forces on the abutment teeth due to their low elastic modulus(3).
~The major disadvantage of a nylon RDP is the inability for a reline procedure and the lack of occlusal rests as well as rigid frameworks, that could lead to occlusal instability and sinking, especially in Kennedy class I and II cases. On the other hand, acetal resins present adequate mechanical strength to form a frame-work more rigid than nylon with retentive clasps, connectors, and supportive elements; however, the acetal resin material lacks natural translucency and vitality."
15979749|NCT03038737|Other|PEEK|PEEK has been successfully used over the last years in the medical ﬁeld, and orthopedics, speciﬁcally. which presents high biocompatibility, good mechanical properties, high temperature resistance, and chemical stability due to a 4 GPa modulus of elasticity, it is as elastic as bone and can reduce stresses transferred to the abutment teeth.Additional advantages of this polymer material are elimination of allergic reactions and metallic taste, high polishing qualities, low plaque afﬁnity, and good wear resistance, it has only recently been used in dentistry.
15979750|NCT03038724|Diagnostic Test|Rapid HIV test|
15979751|NCT03038711|Drug|BMS-986166|Specified dose on specified days
15979752|NCT03038711|Other|Placebo matching BMS-986166|Specified dose on specified days
15979787|NCT03038347|Behavioral|Education only|Six modules containing only PDF-files with text-based information. Participants can download the modules and associated materials from an online platform they need to register for. They receive access to modules once a week. After six weeks the education is completed.
15979788|NCT03038334|Dietary Supplement|Magnesium sulfate|Transdermal application of Magnesium sulfate 250mg every four hours per day for 90 days.
15979753|NCT03038685|Behavioral|Strokecoach.be - digital coaching program for stroke patients|The stroke coach gives patients two education sessions during hospitalization (risk factor management, review of medications and clinical evolution). During these sessions, study participation will be proposed. Eligibility will partially depend on their historical use of the internet and e-mail. The aim is to have the digital platform personalized for his/her individual needs, risk factors and remaining neurologic signs/symptoms. Tips and tricks to deal with lifestyle modification will be delivered on regular basis. Meanwhile, patients will be asked to complete on a pre-specified frequency their data regarding their cardiovascular risk profile. Additionally, participants will be contacted at 0.5-1-2 and 6 months by phone calls or videoconsultancy. To standardize, an adapted, digital version of the standardized WSO Post-Stroke Checklist shall be used as a decision-support flowchart. A report of the consultation will be derived after the videoconsultancy.
15979756|NCT03038659|Device|Penile Duplex|Measuring intima media thickness
15979757|NCT03038646|Drug|MIN-101|
15979758|NCT03038633|Other|Novel Medical Food|This medical food takes advantage of the stability and high level of solubility of the human H-ferritin protein to be absorbed by the body as an iron source; indeed H-ferritin is enriched in breast milk as the mechanism for transferring iron from mother to infants. Once the ferritin has been absorbed from the gut, uptake into each organ is regulated by a specific extracellular receptor pathway to deliver iron in the body's preferred bioavailable form.
15979759|NCT03038620|Drug|Liraglutide|Liraglutide is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the liraglutide dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
15979760|NCT03038620|Drug|Placebo|Placebo is administered once daily by subcutaneous injections with the pen-injector, either in the abdomen, thigh or upper arm. Injections can be done at any time of day irrespective of meals. Subjects will be instructed to escalate the placebo dose to 3.0 mg/day over a 4 week period following an initial dose of 0.6 mg/day and weekly dose escalation steps of 0.6 mg/day.
15979761|NCT03038607|Drug|Aspirin|This group were subjected to aspirin 75 mg once daily for 6 weeks.
15979762|NCT03038594|Drug|Somatropin|
15979763|NCT03038594|Drug|0.09% Saline Solution|
15979764|NCT03038568|Diagnostic Test|CT scan|Patients with colorectal liver metastases scheduled for abdominopelvic CECT will be consented to undergo an additional CT of their abdomen (termed add-on CT) within 15 seconds, before or after, their clinical portal venous phase CT (PV CT), which is performed at a fixed delay of 80 seconds at our institution.
15979765|NCT03038542|Behavioral|Gain-framed text messages|
15979766|NCT03038542|Behavioral|Standard care text messages|
15979767|NCT03038529|Procedure|Classic postrolateral extraarticular percutaneous approach for O3 injection|Receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2 through the classic postrolateral extraarticular percutaneous approach
15979768|NCT03038529|Procedure|Postrolateral transforaminal approach (Yess approach ) for O3 injection|Group B receive 10 ml of ozone oxygen mixture 30 ug O3/ml O2 through postrolateral transforaminal approach (Yess approach ).
15979769|NCT03038516|Drug|Cholecalciferol|To test the hypothesis that vitamin D treatment during 12 weeks to palliative cancer patients is superior to placebo in decreasing opioid consumption, fatigue and infectious burden and increase quality of life.
15979770|NCT03038516|Device|Placebo|To test the hypothesis that placebo is inferior to vitamin D treatment during 12 weeks to palliative cancer patients in decreasing opioid consumption,
15979771|NCT03038503|Drug|Methylene Blue|after defined refractory shock (need NE>0.5 mcg/kg/min) add Methylene blue 1 mg/kg iv drip then 2 hr later drip 0.5 mg/kg/hr*4 hr (intervention add on to standard care)
15979772|NCT03038503|Drug|Terlipressin|after defined refractory shock (need NE>0.5 mcg/kg/min) add terlipressin 1 mg IV then repeated dose 20 min later if unstable BP (intervention add on to standard care)
15979773|NCT03038490|Dietary Supplement|ABOUND|an oral mixture of arginine, glutamine and beta-hydroxy-beta-methylbutyrate
15979774|NCT03038477|Drug|Durvalumab|1500mg of Durvalumab will be given every 4 weeks (Q4W) for 12 months in patients enrolled in Arm A.
15979775|NCT03038464|Diagnostic Test|Synovial biopsy|Biopsy of jint prior reimplantation of new joint prosthesis
15979776|NCT03038451|Drug|S-NOR (s-amlodipine) 2,5 mg & 5 mg tablet|
15979777|NCT03038438|Device|Abre venous self-expanding stent system|venous stent
15979778|NCT03038425|Drug|Normal Saline|This is the placebo intervention - normal saline infused in the adductor canal via a catheter. There are no anticipated therapeutic effect
15979779|NCT03038425|Drug|Ropivacaine|This is the treatment intervention - ropivacaine 0.2% infused in the adductor canal via a catheter. This will provide analgesia to the knee after TKA
15979780|NCT03038399|Drug|Vamorolone 0.25 mg/day/day|Oral administration of 0.25 mg/kg/day daily for 24 months.
15979781|NCT03038399|Drug|Vamorolone 0.75 mg/day/day|Oral administration of 0.75 mg/kg/day daily for 24 months.
15979782|NCT03038399|Drug|Vamorolone 2.0 mg/day/day|Oral administration of 2.0 mg/kg/day daily for 24 months.
15979783|NCT03038399|Drug|Vamorolone 6.0 mg/day/day|Oral administration of 6.0 mg/kg/day daily for 24 months.
15979784|NCT03038386|Other|Dual Energy CT|In this study all patients undergo DECT scan to assess the value of DECT scan in diagnosing acute arthritis caused by gout. If the DECT scan demonstrates MSU depositions and the diagnosis of gout was not ascertained prior to DECT scanning by MSU crystals in the synovial fluid, then additional ultrasound guided aspiration will take place, with knowledge of DECT results, followed by repeat microscopy
15979785|NCT03038373|Procedure|Laparoscopic Sleeve Gastrectomy|Laparoscopic Sleeve Gastrectomy will be conducted based on standard protocol.
15979786|NCT03038347|Behavioral|Training|Six modules containing PDF-files with text-based information, video files, case studies with associated questions and practical exercises. Participants can download the modules and associated materials from an online platform they need to register for. They receive access to modules and associated exercises once a week. After six weeks the training is completed.
15979789|NCT03038321|Drug|sofenacin|solifenacin 10 mg, 6 hours after IVI of BCG and continue for another 2 days post instillation
15979790|NCT03038321|Drug|Tavanic|levofloxacin 500 mg, 6 hours after IVI of BCG and continue for another 2 days post instillation.
15979791|NCT03038321|Drug|Xefo|lornoxicam 8 mg, 6 hours after IVI of BCG and continue for another 2 days post instillation.
15979792|NCT03038308|Drug|Ropinirole|0.25mg/day - 6.0mg/day oral non-ergoline dopamine agonist ropinirole
15979793|NCT03038295|Drug|Propranolol|Oral propranolol:0.25mg/kg daily(every 24 hours)；Eye drop propranolol(0.2%):3 microdrops,in each eye, four times daily (every 6 hours) .Both administration routes will be discontinued until retinal vascularization will be completed, but no more than 90 days.The study will be discontinued immediately in the presence of serious adverse effects attributable to the pharmacological actions of propranolol (severe hypotension, bradycardia or bronchospasm).In case of surgery or induction of anesthesia during the administration of propranolol, the drug should be discontinued at least 24 hours before surgery.In cases of severe hypotension or bradycardia may be administered one or more of the following drugs:Atropine.Isoproterenol hydrochloride (isoprenaline).Terlipressin.Glucagon In case of severe bronchospasm may be used salbutamol aerosol or salbutamol + ipratropium bromide. Betamethasone could be used for aerosol or systemic (intravenous or intramuscular).
15979794|NCT03038295|Drug|placebo|Oral/eye drop placebo will be taken in enrolled newborns. Other treatment will follow the standard treatment schedule of Early Treatment For Retinopathy Of Prematurity Cooperative Group.
15979795|NCT03038282|Dietary Supplement|Chromium Chloride|Transdermal chromium chloride 50 to 600 mcg/day.
15979796|NCT03038282|Other|Individual Exercise|Participants will engage in 150 minutes of exercise over 3-5 days per week for 12 weeks
15979797|NCT03038269|Behavioral|Upper Extremity Robotics, tDCS|Participant will receive 20 minutes of non-invasive brain stimulation followed by one hour of shoulder/wrist robotic training.
15979798|NCT03038256|Drug|concurrent capecitabine-based long-term radiotherapy followed by 4 cycles XELOX and a delayed TME|"concurrent capecitabine-based long-term radiotherapy: capecitabine 825mg/m2,bid,d1-5, q week with Radiation treatment. Radiation treatment was given at 1·8 Gy per day, 5 days per week for 5-6 weeks, after a 45 Gy radiation dose in 25 fractions to the pelvis, a boost dose of 5·4 Gy in 3 fractions to the tumor bed or concurrent boosted.
~XELOX:
~Oxaliplatin: 130mg/m2,IV,d1; Capecitabine: 1000mg/m2,bid,d1-14; repeated every 3 weeks
~Surgery Procedure:
~Total Mesorectal Excision"
15979799|NCT03038256|Drug|concurrent capecitabine-based long-term radiotherapy followed by a Regular TME and 6 Cycles XELOX|"concurrent capecitabine-based long-term radiotherapy: capecitabine 825mg/m2,bid,d1-5, q week with Radiation treatment. Radiation treatment was given at 1·8 Gy per day, 5 days per week for 5-6 weeks, after a 45 Gy radiation dose in 25 fractions to the pelvis, a boost dose of 5·4 Gy in 3 fractions to the tumor bed or concurrent boosted.
~XELOX:
~Oxaliplatin: 130mg/m2,IV,d1; Capecitabine: 1000mg/m2,bid,d1-14; repeated every 3 weeks
~Surgery Procedure:
~Total Mesorectal Excision"
15979800|NCT03038243|Biological|Shigella flexneri 2a whole cell (Sf2aWC) vaccine and double mutant E. coli heat labile toxin (dmLT)|2.25 x 10^11 Sf2aWC cells +10 µg dmLT administered orally on Days 0, 28, and 56
15979801|NCT03038243|Biological|Shigella flexneri 2a whole cell (Sf2aWC) vaccine|2.25 x 10^11 Sf2WC cells administered orally on Days 0, 28, and 56
15979802|NCT03038243|Other|Placebo|2.0 grams of NaHCO3 dissolved in 150 mL of sterile water
15979803|NCT03038230|Drug|MCLA-117 bispecific antibody|MCLA-117, a human bispecific IgG antibody which targets CLEC12A and CD3
15979804|NCT03038217|Drug|Capecitabine +/- Oxaliplatin|Patients in ACT group will undergo postoperative adjuvant chemotherapy with single agent Capecitabine regimen or combined Capecitabine +Oxaliplatin regimen.
15979805|NCT03038217|Procedure|local resection|Patients in the LR group will undergo local resection of the T1-2N0 rectal carcinoma
15979806|NCT03038217|Procedure|radical resection|Patients in the RR group will undergo radical resection of the T1-2N0 rectal carcinoma
15979807|NCT03038217|Other|No adjuvant chemotherapy|Patients in Non-ACT group will not undergo postoperative adjuvant chemotherapy.
15979808|NCT03038204|Procedure|The papillary muscle approximation|"Surgery is performed through median sternotomy, aortic and bicaval cannulation, normothermic perfusion, and antegrade cardioplegia with the use of cardioplegic solution.
~After coronary anastomosis, the mitral valve is exposed by a transseptal incision.
~The papillary muscles are approximated through the mitral valve at the level of papillary muscles heads. Nonabsorbable, braided sutures of 2-0 (Ethibond, Ethicon, Inc.) with PTFE felt pledgets are used for this purpose.
~Annuloplasty mitral rings of different sizes are anchored using multiple deep U-shaped stitches of Ethibond 2-0 (Ethicon, Inc., USA). After MV repair, the LV is forcefully filled with saline water to test the valve competence. After satisfactory hydraulic test walls of the heart chambers are sutured."
15979809|NCT03038191|Device|Neuroelectrics Enobio 8(R)|Monitoring
15979810|NCT03038178|Drug|LAI plus multi-drug regimen|Liposomal Amikacin for Inhalation (LAI) is the experimental treatment which, in this single arm will be taken in conjunction with standard of care multi-drug treatment regimen
15979811|NCT03038152|Procedure|Axillary Lymph Node Dissection|Undergo targeted axillary lymph node dissection
15979812|NCT03038152|Procedure|Localization|Undergo axillary lymph node localization
15979813|NCT03038152|Device|Medical Device|Receive Magseed via ultrasound guided injection
15979814|NCT03038139|Other|Cervical exercises|Cervical correction program consist of 3 strengthening and 2 stretching exercises for neck and scapula Lumbosacral correction program consist of strengthening and stretching exercises for lumbar and sacral regions
15979815|NCT03038139|Other|Lumosacral exercises|Cervical and Lumbosacral correction program Lumbosacral program consist of 2 strengthening and 4 stretching exercises
15979816|NCT03038126|Other|CCHT|Veterans Administration (VA) CCHT program available to veterans with difficult to manage chronic conditions and employing an established guideline-based CKD DMP, augmented laboratory monitoring, and decision support from the VA Renal Inter-disciplinary Safety clinic (RISC).
15979817|NCT03038126|Other|Usual care|Standard clinical care
15979818|NCT03038113|Drug|RO7062931|Administered subcutaneously in Parts 1 and 2. Part 1 will be administered in single-ascending doses after 0.1 mg/kg starting dose. Subsequent doses of 0.3, 1, 2 and 4 mg/kg may be administered based upon tolerability. In Part 2a, participants will receive two monthly doses of either 0.4, 0.8, 1.2 times the saturation dose or placebo. In Part 2b, a dose selected from Part 2a will be administered to participants randomized into 4 cohorts QW or Q2W. In Part 2c, participants will receive RO7062831 QW on top of another therapy for up to 24 or 48 weeks.
15979819|NCT03038113|Drug|Placebo|Part 1 cohorts: active drug vs placebo 4:1. Part 2a 4 parallel cohorts of 3 active drug doses and placebo in 1:1:1:1. Part 2b active drug vs placebo in 3:1 in 2 parallel cohorts.
15979820|NCT03038113|Drug|Immune Modulator|Participants in Part 2c will receive an immune modulator subcutaneously QW for up to 48 weeks.
15979821|NCT03038100|Drug|Paclitaxel|Paclitaxel 175 milligrams per square meter (mg/m^2) IV infusion on Day 1 of each 21-day cycle
15979822|NCT03038100|Drug|Carboplatin|Carboplatin at a dose to achieve a target area under the curve (AUC) of 6 milligrams per milliliter*minute (mg/mL*min) on Day 1 of each 21-day cycle for a total of 6 cycles
15979823|NCT03038100|Drug|Atezolizumab|Atezolizumab 1200 mg IV infusion on Day 1 of each 21-day cycle
15979824|NCT03038100|Drug|Bevacizumab|Bevacizumab 15 milligrams per kilogram (mg/kg) IV infusion as per the schedule specified in respective arms
15979825|NCT03038100|Drug|Atezolizumab Placebo|Placebo matching to atezolizumab on Day 1 of each 21-day cycle
15979826|NCT03038087|Device|SENSE Device|"The SENSE device transmits a low power tailored electro-magnetic pulse across the patient's brain and detects changes in the signal that may indicate intracranial hemorrhage. The device consists of two parts:
~A molded plastic headpiece containing the antenna array, and
~A processing control unit.
~The SENSE device will be placed on the subject within 15 minutes of a baseline head CT, or as soon as practicable. The SENSE device will be set to scan every 10 minutes until the device is removed after completion of the SENSE measurement corresponding to the 72 hour CT scan. The investigator will be blinded to the data collected from the SENSE device."
15979827|NCT03038074|Device|Pulse Oximeter with respiration rate sensor|
15979828|NCT03038061|Other|Patients undergoing Laparoscopic Surgery|Data are to be obtained at three phases at supine horizontal position (during spontaneous breathing, at mechanically ventilated patient under general anesthesia with muscle relaxation and at mechanically ventilated patient under general anesthesia with muscle relaxation during insufflation of carbon dioxide into the peritoneal cavity to achieve exposure during laparoscopic surgery).
15979829|NCT03038048|Procedure|Varying needle size with intravitreal ranibizumab or aflibercept|Varying gauge of needle, 33 gauge vs 30 gauge
15979830|NCT03038035|Drug|MLC901|24 weeks intervention with orally MLC901. 2 capsules 3 times a day
15979831|NCT03038035|Drug|Placebo|24 weeks intervention with orally placebo. 2 capsules 3 times a day
15979832|NCT03038022|Drug|MGL-3196|Oral
15979833|NCT03038022|Drug|Placebo|Oral
15979834|NCT03038009|Drug|Pantoprazole|Pantoprazole (40mg qd) will be concomitant used with DAPT
15979835|NCT03037996|Other|patients' response|patients' satisfaction to anesthesia services
15979836|NCT03037983|Device|Repetitive transcranial magnetic stimulation|rTMS is a non-invasive procedure, in which the administration of a transient magnetic field induces electrical currents in specific, targeted brain regions. The intervention will be administered in 20 sessions lasting 50 minutes each over the course of 2-6 weeks. Up to two sessions may be scheduled per day with a one-hour interval in-between.
15979837|NCT03037983|Device|Sham|Subjects will still attend treatment sessions as outlined in the rTMS intervention. However, the device will not deliver any stimulation to the subject.
15979838|NCT03037970|Drug|RhPDGF-BB|One 2x4x.3cm of collagen wound matrix is saturated with 2.0 ml of the rhPDGF-BB solution.
15979839|NCT03037970|Other|Placebo|Collagen Wound Dressing wetted with buffer.
15979840|NCT03037957|Device|ARIES Group A Strep Assay|
15979841|NCT03037944|Drug|Yasmin|(ethinyl estradiol 0.03 mg/ drospirenone 3 mg) tablets
15979842|NCT03037944|Device|Metraplant-E|"Levonorgestrel-releasing Intrauterine System modified levonorgestrel-releasing intrauterine system from the old IUD Metraplant, modified by Azzam 2013"
15979843|NCT03037931|Drug|Ferric Carboxymaltose|Intravenous Iron
15979844|NCT03037931|Drug|Placebo|Normal Saline Solution
15979845|NCT03037918|Dietary Supplement|Yakult light|A fermented milk drink containing the probiotic Lactobacillus casei Shirota
15979846|NCT03037905|Device|SignatureSuite OR Integration System by STERIS Corporation|SignatureSuite OR Integration System by STERIS Corporation is a device that controls audio and visual components of the operating room environment in order to provide a more relaxing and calming operating room environment for patients prior to surgery and on emergence from anesthesia after surgery.
15979847|NCT03037892|Drug|Midazolam, Fentanyl|Two minutes before the colonoscopy procedure, a bolus of midazolam 0.03mg/Kg and 1.5microgram/Kg fentanyl will be given intravenously over 60 sec in group 1. 0.5 mg of midazolam intravenously can be given every two minutes till the patient is sufficiently sedated (sleeping but arousable on calling). The colonoscopy can start at this end point. Increments of 0.5mcg/Kg of fentanyl will be given if patient complains of pain, which can be repeated every 5 minutes if there is persistent pain.
15979848|NCT03037892|Drug|Midazolam, Remifentanil|The patient in group 2 Target controlled infusion of Remifentanil to 3.0 ng/ml will be started 2 minutes before procedure. The patient will then be given same doses of midazolam in 0.5 mg increments till sedated sufficiently (sleeping but arousable on verbal command). During Colonoscopy the dose of Remifentanil could be increased by 0.5ng/ml if patient complained of pain upto 4.0ng/ml.
15979849|NCT03037892|Drug|Remifentanil|The group 3 patient will receive only Remifentanil in the same doses as given in group
15979850|NCT03037879|Other|SPT|Participants in the SPT group will receive 10 training sessions over 5 weeks.
15979851|NCT03037879|Other|SPT Control|Participants in the SPT control group will receive 10 computer-based control sessions over a five-week period during which they will engage in computer-based training. However, they will not be exposed to the training materials central to the SPT.
15979852|NCT03037879|Other|mSMT|Participants in the mSMT group will meet with the trainer twice per week for five weeks. Sessions last 45-60 minutes each and are spread over 5 weeks.
15979853|NCT03037879|Other|mSMT Control|Participants in the mSMT control group will meet with the therapist at the same frequency and for the same duration as those in the mSMT experimental group. However, subjects will not be exposed to the training materials central to the mSMT.
15979854|NCT03037866|Behavioral|LifeSkills Training for College|The intervention will consist of e-learning modules (self-guided) and small-group sessions (facilitator led). The intervention is designed for new college students and is aimed at providing tools and strategies to help them maximize opportunities and adeptly handle the challenges ahead. The intervention will teach them the knowledge and skills needed to stay safe from problems that are prevalent among new students on college campuses, such as alcohol and drug abuse and sexual violence.
15979855|NCT03037853|Other|Healthy volunteers|MRI scanner
15981171|NCT03028142|Drug|1.5 mg RPL554 plus tiotropium|
15979856|NCT03037840|Device|Low intensity amplitude-modulated RF EMFs|Low intensity amplitude-modulated radiofrequency electromagnetic fields,the carrier frequency is 27.12MHz with a power of about 100mW
15979857|NCT03037827|Procedure|Endovenous laser ablation (EVLA)|Endovenous laser ablation with laser wavelength 1470 nm and radial laser fiber
15979858|NCT03037827|Device|Laser|Device for endovenous laser ablation manufactured by Biolitec AG company (ELVeS system) - diode laser with a wavelength of 1470 nm
15979859|NCT03037814|Device|Compomer|Aesthetic resin dental materials that are used to replace structure loss, commonly for dental caries of primary tooth. Compomers designed to combine the aesthetics of traditional composite resins with the fluoride release and adhesion of glass-ionomer cements.
15979860|NCT03037814|Device|RMGIC|Dental restorative materials that are a combination of the desirable properties of glass-ionomer (fluoride release and chemical adhesion) with high strength and low solubility of resins.
15979861|NCT03037814|Device|Giomer|Giomers are dental materials that are hybrid of compomers and glass ionomers, and are used to restore dental caries.
15979862|NCT03037814|Device|Amalgam|Amalgam is a silver-colored dental restorative material that can be used to restore both primary and permanent posterior teeth which have dental caries.
15979863|NCT03037801|Device|Intrapulmonary Percussive Ventilation (Percussionaire Corp, Sandpoint, Idaho)|IPV physiotherapy 3 times a day
15979864|NCT03037788|Drug|WO3979|Application of cream to each axilla
15979865|NCT03037788|Drug|WO3970|Application of cream to each axilla
15979866|NCT03037788|Drug|WO3992|Application of cream to each axilla
15979867|NCT03037788|Drug|Placebo (WO3988)|Application of cream to each axilla
15979868|NCT03037775|Other|Baseline|measurement of baseline hemodynamic parameters
15979869|NCT03037775|Device|e-cigarette without nicotine|measurement hemodynamic parameters during smoking e-cigarette without nicotine
15979870|NCT03037775|Device|e-cigarette with nicotine|measurement hemodynamic parameters smoking e-cigarette with nicotine
15979871|NCT03037775|Device|traditional cigarette|measurement hemodynamic parameters smoking traditional cigarette
15979872|NCT03037762|Procedure|Flexible Endoscopic Evaluation of Swallowing|
15979873|NCT03037749|Drug|Alcohol beverage|Alcohol beverage
15979874|NCT03037749|Drug|Placebo beverage|Placebo beverage
15979875|NCT03037736|Drug|5-Fluorouracil|5-fluorouracil is an antimetabolite that is commonly used in glaucoma surgery to prevent postoperative scaring.
15979876|NCT03037736|Drug|Bevacizumab|Bevacizumab is an anti-VEGF antibody that is commonly used to prevent or treat neovascularization in retinal disorders.
15979877|NCT03037736|Drug|Normal saline|Normal saline will be used as the placebo.
15979878|NCT03037723|Other|CT simulation|
15979879|NCT03037710|Device|HealthPatch|A multi-sensor device to collect continuous vital signs
15979880|NCT03037697|Other|TheraTogs Arm|TheraTogs Arm Received Soft Orthotic undergarments
15979881|NCT03037697|Other|Traditional Treatment|"Traditional treatment to Dyskinetic CP
~1- Trunk control exercises 2- Core stability training 3- Proximal dynamic stability for the shoulder and pelvic girdles components. 4- Back and abdominal strengthening exercises 5- Standing exercises : - Standing alone gradually increase time. - Stride standing alone. - Step standing alone (other limb supported on wooden step then soft step and finally on small ball). - Standing on balance board"
15979882|NCT03037684|Diagnostic Test|neurophysiology|electrophysiologic measurements of peripheral nerves
15979883|NCT03037671|Device|Continuous Glucose Monitor (CGM)|Participants will wear the continuous glucose monitor (GCM) device during the peri-HSCT period for the duration of their initial hospital admission. No intervention based on results.
15979884|NCT03037658|Other|Offering a financial incentive to increase walking|"After a baseline week of walking while wearing a pedometer, participants will be randomly assigned to one of the five conditions. In each of these conditions, participants will have the chance to earn .02/step for each additional step per day (on average across the week, above baseline levels). After a week of incentivized walking, participants will again be asked to wear the pedometer for one final week (with no incentive).
~Because the investigators need a week of walking before the incentive week, it is important that participants do not know the specific incentive aspect at the beginning of the study. Therefore, the investigators will not disclose the incentive structure at the beginning of the study. The investigators will debrief participants at the end of the study, and they will be fully informed of the purposes of the study at that time."
15979885|NCT03037645|Drug|SNS-062|SNS-062 will be orally administered twice daily and available in capsules containing either 25 mg or 100 mg of active ingredient.
15979886|NCT03037632|Behavioral|Family Heart Talk Booklet|
15979887|NCT03037619|Behavioral|Fitbit|Participants randomized to Fitbit will be mailed a Fitbit and encouraged to wear it over the next 4 months
15979888|NCT03037619|Behavioral|Fitbit+Support|"Participants will identify a Buddy and both the participant and Buddy will be mailed a Fitbit. Both participant and Buddy will be asked to Friend each other on Fitbit and encouraged to wear the monitor over the next 4 months."
15979889|NCT03037606|Drug|Rabelis DDR 50 mg Capsules|Rabelis DDR 50 mg Capsules once daily for seven days.
15979890|NCT03037606|Drug|Pariet 20 mg Enteric Coated Tablets|Pariet 20 mg Enteric Coated Tablets once daily for seven days.
15979891|NCT03037593|Drug|4000 IU vitamin D3|vitamin D supplementation (4000 IU vitamin D3 +prenatal vitamin
15979892|NCT03037580|Drug|Oral treprostinil|Sustained-release oral tablets for TID administration
15979893|NCT03037580|Drug|Placebo|Placebo (sugar pill) for TID oral administration
15979894|NCT03037567|Behavioral|Modified Weight Watchers plan|Weight Watchers is a structured lifestyle modification program that includes a food plan based on balanced diet and healthy eating, activity plan designed to promote progressive physical activity increase, group support and cognitive behavior modification. Participants attend weekly in-person group meetings led by a trained Weight Watchers meeting leader and have a suite of electronic tools available through an iPhone app.
15979895|NCT03037554|Device|Sleepwear with Lateralized Thermal Characteristics|Subjects will wear sleepwear constructed with insulating fabric on one side and conductive fabric on the other side, arranged bilaterally.
15979896|NCT03037554|Device|Sham-Lateralized Sleepwear|Subjects will wear sleepwear constructed with two insulating fabrics arranged bilaterally.
15979897|NCT03037541|Drug|Carac Cream|Carac Cream will be used once daily for seven consecutive days
15979898|NCT03037541|Drug|Placebo Cetaphil cream|Placebo Cetaphil Cream will be used once daily for seven consecutive days
15979899|NCT03037528|Behavioral|diet and lifestyle program|Participants will be taught how to follow a very low carbohydrate, ketogenic diet, become more physically active, and get adequate sleep.
15979900|NCT03037528|Behavioral|positive affect informational materials|Participants will be taught about positive affect skills, such as gratitude, positive reappraisal, and personal strengths.
15979901|NCT03037528|Behavioral|mindfulness informational materials|Participants will be taught about mindfulness and mindful eating techniques.
15979902|NCT03037528|Behavioral|dietary tracking|Participants will be asked to track their diet consistently.
15979903|NCT03037515|Drug|Tranexamic Acid|To identify if intravenous tranexamic acid is superior to oral tranexamic acid in reducing blood loss and need for transfusion in lumbar spine surgery.
15979904|NCT03037502|Behavioral|Tailor Made: Solutions for your health (A su Medida: Soluciones para su salud)|Assess the effectiveness of a person-specific, randomized controlled pilot weight loss study of 80 African American and 40 Latino men; to compare changes in chronic disease risk behaviors (e.g., diet and physical activity), adiposity measures (e.g., body fat), and psychosocial mediators (e.g., social support, autonomous motivation) between data collected at baseline and at 3-months.
15979905|NCT03037489|Drug|MIV-711|MIV-711 administered orally once daily
15979906|NCT03037476|Behavioral|Web-based PFI|A web-based 5 component Personalized Feedback Tool covering content on: 1) Stimulants, 2) Marijuana, 3) PSM and unwanted effects, 4) Academics, and 5) Alcohol.
15979907|NCT03037476|Behavioral|In-person PFI|A 1.5 hour in-person brief personalized feedback intervention utilizing a motivational interviewing approach to discuss the student's PSM misuse, alcohol and other drug use, and review personalized graphic feedback.
15979908|NCT03037450|Procedure|Miniinvasive corneal neurotization|Neurotization of a neurotrophic cornea
15979909|NCT03037437|Drug|Sorafenib (SOR)|Patients will receive SOR 400 mg by PO twice daily on Cycle1/Day1 (C1D1).
15979910|NCT03037437|Drug|Hydroxychloroquine (HCQ)|400mg by mouth daily
15979911|NCT03037424|Drug|Octafibrin|Octafibrin will be administered when the blood bank receives an order for fibrinogen supplementation
15979912|NCT03037424|Drug|Cryoprecipitate|Cryoprecipitate will be administered when the blood bank receives an order for fibrinogen supplementation
15979913|NCT03037411|Device|Peripheral stenting|stent implantation during the index procedure
15979914|NCT03037398|Device|Vercise Deep Brain Stimulation System|
15979915|NCT03037385|Drug|pralsetinib (BLU-667)|pralsetinib (BLU-667) is a potent and selective inhibitor of the RET mutations, fusions, and predicted resistant mutants
15979916|NCT03037372|Drug|ART, Atorvastatin|ART, Atorvastatin
15979917|NCT03037372|Drug|ART, Rosuvastatin|ART, Rosuvastatin
15979918|NCT03037372|Drug|ART, No statin|ART, No statin
15979919|NCT03037372|Drug|Healthy-HIV-negative|Age-matched, Healthy HIV-negative
15979920|NCT03037359|Biological|Bivigam|Human immune globulin
15979921|NCT03037359|Biological|Other|Human immune globulin
15979922|NCT03037346|Other|Questionnaire Administration|Complete questionnaires about MPOAD
15979923|NCT03037346|Other|Questionnaire Administration|Ancillary studies
15979924|NCT03037346|Other|Video|Watch educational video
15979925|NCT03037333|Procedure|Transvenous cardiac pacing guided by fluoroscopy|Transvenous cardiac estimulation
15979926|NCT03037333|Procedure|Transvenous cardiac pacing guided by ECG/ECHO|Transvenous cardiac estimulation
15979927|NCT03037320|Procedure|comparison of coronally advanced flap and semilunar vestibular incision technique for root coverage in maxillary teeth|
15979928|NCT03037307|Other|Test Product|Five strips of test adhesive cream for upper denture, as per application instructions.
15979929|NCT03037307|Other|Positive Contol|Three dabs of positive control adhesive cream for upper denture, as per application instructions.
15979930|NCT03037307|Other|Negative Control|No adhesive
15979931|NCT03037294|Dietary Supplement|Preoperative protein supplementation|Daily 40 g of pre-sleep protein supplementation during 2-week preoperative period.
15979932|NCT03037281|Diagnostic Test|Septic|30mls of blood will be sampled by venepuncture, or sampled from indwelling lines (in the case of septic patients on intensive care). Blood will be sampled using standard techniques, and transferred to EDTA containing blood bottles, and undergo processing immediately.
15979933|NCT03037268|Device|Lytro Plenoptic Camera and 28D lens|"visual acuity measured, intraocular pressure obtained, eyes dilated as part of a standard exam for intended patient visit
~screened and consented for study
~subjected to bilateral plenoptic ophthalmoscopy
~mydriatic, single-field fundus images obtained
~images reviewed for quality and diagnostic utility by a masked grader"
15979934|NCT03037255|Other|long term conditions|Long term conditions including diabetes mellitus, chronic obstructive pulmonary disease or asthma, chronic heart failure, chronic renal failure, cerebrovascular disease or peripheral vascular disease.
15979935|NCT03037242|Procedure|Transtibial pullout technique|Evaluating radographs
15979936|NCT03037229|Device|Smartphone ECG|
15979937|NCT03037229|Device|Standard 12-lead ECG|
15979938|NCT03037216|Other|Exercise Intervention|10 Week aerobic exercise training
15979939|NCT03037203|Drug|JZP-110|75 mg, 150 mg, 300 mg
15979940|NCT03037203|Other|Placebo|
15979941|NCT03037190|Other|withdrawal of gluten from the diet|Gluten free diet the same recommendations as for patients with diabetes and known celiac disease
15979942|NCT03037164|Device|INTERCEPT Blood System for Red Blood Cells|The pathogen reduction process begins with a unit of RBCs derived from whole blood that is separated according to local regulations and standard operating procedures at the Blood Centers. RBCs are suspended in AS-5. Leukocyte-reduction of whole blood or RBCs will be performed per manufacturer's instructions. The INTERCEPT Blood System process is performed on a single unit of leukocyte-depleted RBC in AS-5.
15979943|NCT03037164|Device|Conventional (Control)|Conventional RBC components ordered and administered to study patients by their treating physicians according to the local standards of care
15979944|NCT03037151|Drug|Grazaoprevir/Elbasavir|treatment naive
15979945|NCT03037151|Drug|Grazaoprevir/Elbasavir/RBV|treatment experienced
15979946|NCT03037138|Other|Blood flow Rate profiling|Blood flow rate profiling during dialysis session
15979947|NCT03037125|Procedure|Split Crest with PRF|Narrow ridges are split to increase the ridge width and immediate implants are placed with PRF closing the gap
15979948|NCT03037125|Procedure|Split Crest without PRF|Narrow ridges are split to increase the ridge width and immediate implants are placed without grafting
15979949|NCT03037112|Behavioral|Education|The first intervention is an educational intervention regarding appropriate diagnosis and treatment of common respiratory infections. This education will be delivered in an interactive lecture format for providers with follow up short informational video clips available over the course of the project.
15979950|NCT03037112|Behavioral|Communication Skills|The second intervention is an education plus communication skills training intervention. This training session will include identical antibiotic education training, good and bad communication examples, training on negative behavioral framing, and education regarding key drivers of patient satisfaction. Additionally providers will be informed of parent's desire for antibiotics rating prior to their consultation with the patient.
15979951|NCT03037099|Behavioral|Enhanced GI Concept Education|
15979952|NCT03037073|Drug|Duloxetine|35 patients will receive duloxetine (Cymbalta; Eli Lilly & Company, Indiana, USA) 30 mg orally with sips of water, 2 h before induction of anesthesia.
15979953|NCT03037073|Drug|Placebo oral capsule|35 patients will receive similar-looking placebo capsules (starch capsules) orally with sips of water, 2 h before induction of anesthesia.
15979954|NCT03037060|Other|[11C]-(+)-PHNO PET scan|PET scan
15979955|NCT03037060|Other|Alcohol Self-Administration|Session for assessing motivation for consuming alcohol.
15979956|NCT03037060|Other|Craving Task|Cue exposure paradigm
15979957|NCT03037060|Other|MRI scan|MRI scan scan to analyze the PET data will be administered.
15979958|NCT03037060|Other|Neuropsychological Assessment|Cognitive questionnaires administered over course of study.
15979959|NCT03037047|Drug|0.9% Sodium Chloride Injection|Patients will treated with 0.9% Sodium Chloride Injection on the basis of conventional therapy for 14 days.
15979960|NCT03037047|Drug|salvianolate injection|Patients will treated with salvianolate injection on the basis of conventional therapy for 14 days.
15979961|NCT03037034|Device|Forcep|"Following the injection around a submucosal tumor, the adjacent mucosa or submucosa was grasped with the forceps and pulled away to form a tent. The tissue was dissected using an electrocoagulating current."
15979962|NCT03037008|Device|Perineal Sonography|In a modified lithotomy position (supine position with elevated legs), probands will get an examination of their pelvic floor by using a common ultrasound probe head on the perineum. During the examination, the bladder should be filled with around 300ml. If patient appear with empty bladder, the examination can be repeated on an other date. During the examination, the pelvic floor will be observed during rest, coughing and valsalva-maneuver. One examination takes around 30minutes. During ultrasound, we want to illustrate the urethral mobility, the bladder neck opening and the urethral angle as well as the distance from the urethra to the symphysis.
15979963|NCT03036995|Drug|Apremilast|Patient will receive narrow UVB treatment and apremilast (2 tablets for day) during 24 weeks. If the patient is responder (response is defined as an increase of at least 30 % in the VASI score at W24 compare to Baseline), he will receive narrow UVB treatment according the and apremilast during 24 weeks.
15979964|NCT03036995|Other|Placebo|Patient will receive narrow UVB treatment and placebo (2 tablets for day) during 24 weeks. If the patient is responder (response is defined as an increase of at least 30 % in the VASI score at W24 compare to Baseline), he will receive narrow UVB treatment according the and placebo during 24 weeks.
15979965|NCT03036943|Radiation|Fluciclovine|Fluciclovine (18F) PET/CT scan completed >= 48 hours prior to surgical resection for breast cancer
15979966|NCT03036930|Other|Laboratory Biomarker Analysis|Correlative studies
15979967|NCT03036930|Other|Questionnaire Administration|Ancillary studies
15979968|NCT03036930|Biological|Recombinant Human Papillomavirus Nonavalent Vaccine|Given IM
15979969|NCT03036904|Drug|Venetoclax|Venetoclax will be administered orally on days 3-12 in cycle 1, and days 1-10 with all subsequent cycles except dose level -1. If dose level -1 is required, venetoclax will be administered on days 3-7 in cycle 1 and 1-5 with subsequent cycles.
15979970|NCT03036904|Drug|Rituximab|Rituximab will be administered as an IV infusion at 375 mg/m2 on day 1 of each cycle of DA-EPOCH-R, immediately prior to the start of chemotherapy. Oral pre-medication 650 mg of acetaminophen and 50-100 mg diphenhydramine hydrochloride will be administered 30 to 60 minutes prior to starting each infusion of rituximab. The first rituximab infusion should be started at 50 mg/hr, and increased in 50-mg/hr increments every 30 minutes to a maximum rate of 400 mg/hr. If this rate of escalation is well tolerated the second and subsequent infusions can begin at a rate of 100 mg/hr and increase in 100 mg/hr increments every 30 minutes to a maximum of 400 mg/hr. CAUTION: DO NOT ADMINISTER AS AN INTRAVENOUS PUSH OR BOLUS.
15979971|NCT03036904|Drug|Etoposide|Etoposide will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. The drug will be given by IV route.
15979972|NCT03036904|Drug|Vincristine Sulfate|Vincristine Sulfate will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. The drug will be given by IV route.
15979973|NCT03036904|Drug|Cyclophosphamide|Cyclophosphamide will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. The drug will be given by IV route.
15979974|NCT03036904|Drug|Prednisone|Prednisone will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. Prednisone will be given orally.
15979975|NCT03036904|Drug|Doxorubicin Hydrochloride|Doxorubicin Hydrochloride will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. The drug will be given by IV route.
15979976|NCT03036891|Drug|Naloxegol 25 MG Oral Tablet [Movantik]|Patients will be given the study drug (Movantik 25 mg).They will take this daily in the morning 1 hour before breakfast for four weeks.
15979977|NCT03036891|Drug|Placebo Oral Tablet|Patients will be given Placebo (Placebo 25 mg).They will take this daily in the morning 1 hour before breakfast for four weeks.
15979978|NCT03036878|Other|ReNu|ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid.
15979979|NCT03036865|Drug|BOS161721|Single dose administered IV or SC
15979980|NCT03036865|Drug|Placebo|Single dose administered IV or SC
15979981|NCT03036852|Drug|SOF/VEL|400/100 mg fixed-dose combination (FDC) tablet(s) administered orally once daily
15979982|NCT03036839|Drug|LDV/SOF|90/400 mg fixed- dose combination (FDC) tablet administered orally once daily
15979983|NCT03036826|Drug|Piperacillin/tazobactam|antiinfective therapy with Piperacillin/Tazobactam within routine care
15979984|NCT03036826|Drug|Meropenem|antiinfective therapy with Meropenem within routine care
15979985|NCT03036813|Drug|voxelotor|
15979986|NCT03036813|Other|Placebo|
15979987|NCT03036800|Drug|Saxenda|standard care plus targeted use of Liraglutide (LIRA) 3mg when pre-specified stopping rules for the medication apply. Liraglutide (Saxenda) 6 mg/mL solution for injection in pre-filled pen, administered by subcutaneous injection. Dose escalation to 3.0 mg daily (or maximum tolerated dose)
15979988|NCT03036800|Other|Specialist Obesity Management Services|Specialist Obesity Management Services standard of care
15979989|NCT03036787|Behavioral|family based intervention|behavioural advises to family for normal motor development
15979990|NCT03036774|Procedure|Ultrasonic measurement of antral area|"Antral area is measured by ultrasound using a curvilinear abdominal probe of 2-5 MHz and a Logiq E (General Electrics) type echograph or equivalent.
~Ultrasound is done before the induction of general anesthesia. Three consecutive measurements of the anteroposterior (AP) and cranio-caudal (CC) diameters are performed.
~Antral area (CSA expressed in mm²) is show by the following formula: CSA = AP × CC × π / 4.
~Antral area will correspond to the average of the three measures."
15979991|NCT03036761|Procedure|Auriculotherapy|3 sessions of auriculotherapy at one month intervals.
15979992|NCT03036748|Dietary Supplement|Standardized sodium diet|Dietary Supplement: Standardized salt diet 150 mmol NaCl per day given as three meals daily for 5 consecutive days.
15979993|NCT03036748|Drug|Tbl amiloride|Drug: Amiloride Amiloride tablet 10-20 mg two times daily (morning and afternoon) for one day
15979994|NCT03036735|Device|steroid eluting spacer|The Restora Mometasone Furate Eluting Spacer will be compared to the Silastic spacer.
15979995|NCT03036722|Other|Flaxseed|Flaxseed is a member of the genus Linum in the family Linaceae. It is a food and fiber crop and it occurs in two basic varieties: brown and yellow or golden (also known as golden linseeds).
15979996|NCT03036722|Other|Placebo control porridge|control porridge matched for energy and fat content.
15979997|NCT03036696|Other|Pregnant Mothers Interview|"Pregnant mothers will be interviewed and asked to provide feedback on common strategies used for recruitment, challenges that would preclude them from enrolling and participating in CRTs, their preferences for incentives, data collection, bio-specimen collection and preferences for methods related to non-invasive sample collection.
~Data collection for pregnant mothers includes Clinical Health Update (3rd trimester) and Physical Activity questionnaires.
~The following will be collected from mothers during the interview: self-reported behavioral data, maternal human milk (HM), stool, urine, saliva, and vaginal swab."
15979998|NCT03036696|Other|Breastfeeding Mothers Interview|"Breastfeeding mothers will be interviewed and asked to provide feedback on common strategies used for recruitment, challenges that would preclude them from enrolling and participating in CRTs, their preferences for incentives, data collection, bio-specimen collection, and preferences for methods related to non-invasive sample collection.
~Data collection for breastfeeding mothers includes Clinical Health update (post-natal), Infant Feeding, and Physical Activity questionnaires.
~The following will be collected from mothers during the interview: self-reported behavioral data, maternal human milk (HM), stool, urine, saliva, and vaginal swab."
15979999|NCT03036683|Device|Transcranial direct current stimulation|Transcranial direct current stimulation will be administered for 20 minutes using a CE approved stimulator (NeuroConn, Ilmenau, Germany).
15980000|NCT03036683|Device|Sham transcranial direct current stimulation|The same device will be used as in the active stimulation group, but stimulation will be terminated after 30 seconds.
15980001|NCT03036657|Device|MAC acupuncture needles|"Sterile single-use MAC acupuncture needles (0.22 x 25 mm, TianJin Haing Lim Sou Won Medical Equipment Co, Ltd, South Korea. Used for Manual Acupuncture
~Used for: Manual Acupuncture to PC3, PC5 or HT3, HT4 for 20 min"
15980002|NCT03036657|Device|Electrostimulator 6c.Pro, Pantheon Research, Venice, CA|"Electrostimulator used for delivery or Low-Frequency or High-Frequency Electroacupuncture
~Used for Interventions:
~Low-frequency Continuous Electroacupuncture to PC3, PC5 or HT3, HT4 for 20 min AND High-frequency Continuous Electroacupuncture to PC3, PC5 or HT3, HT4 for 20 min"
15980003|NCT03036644|Device|e-cigarette (PG+VG without nicotine; low temperature)|
15980004|NCT03036644|Device|e-cigarette (PG+VG with nicotine; low temperature)|
15980005|NCT03036644|Device|e-cigarette (PG+VG without nicotine; high temperature)|
15980006|NCT03036644|Device|e-cigarette (PG+VG with nicotine; high temperature)|
15980007|NCT03036644|Other|tobacco cigarette|
15980008|NCT03036618|Dietary Supplement|Quinoa|Test wheat bread roll (approximately 160g weight) delivering 20 g quinoa consumed per day.
15980009|NCT03036618|Dietary Supplement|Wheat|Test wheat bread roll (approximately 160g weight) without quinoa.
15980010|NCT03036605|Drug|Bupivacaine|%0.5 bupivacaine
15980011|NCT03036605|Drug|Dexamethasone|8 mg Dexamethasone
15980012|NCT03036592|Behavioral|Early OGTT|Test glucose tolerance using identical mixed 75 gr of glucose under early condition (4 hours before habitual bedtime)
15980013|NCT03036592|Behavioral|Late OGTT|Test glucose tolerance using identical mixed 75 gr of glucose under late condition (1 hour before habitual bedtime)
15980014|NCT03036579|Device|Celtra Duo|Full ceramic crowns will be made from the high strength ceramic, Celtra Duo.
15980015|NCT03036566|Device|Lithium disilicate ceramic (Ivoclar)|Three unit high strength ceramic bridges replacing a single tooth.
15980016|NCT03036553|Other|Diagnosis/Prognosis|The present study will be a prospective multi-centric 12-month study that will be conducted between May 2017 and April 2019 in four primary care centers and a hospital in the province of Malaga. Several questionnaires assessing different psychological factors will be administered to these participants. The results will be evaluated at baseline (t1) and at 3-fold follow-up (after 3 (t2), 6 (t3) and 12 months (t4)).
15980017|NCT03036540|Device|application in midline catheter|The routine insertion of midline catheter for the patients admitted in hospital who needs peripheral venous approach for the period more than 5 days or with the insufficient peripheral veins system
15980058|NCT03036319|Device|Sham tRNS|Participants will receive sham transcranial random noise stimulation for up to 260 sessions
15980059|NCT03036306|Drug|SCX-001|Nefopam cream formulation
15980060|NCT03036306|Other|Placebo|Cream formulation without Nefopam
15980018|NCT03036527|Procedure|Activity-based locomotor training|The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stepping (IRB 07.0066).
15980019|NCT03036527|Procedure|Activity-based stand training|The weight-bearing activity-based intervention will be provided via a standardized locomotor training program that is provided clinically at Frazier Rehab Institute within the NeuroRecovery Network (NRN); or similar interventions in a research protocol of stand only program (07.0268). The stand only intervention may also be provided as part of this study.
15980020|NCT03036527|Procedure|Activity-based upper arm ergometry|The non-weight bearing activity-based upper arm ergometry intervention will be provided via a standardized arm crank therapy provided within this study.
15980021|NCT03036514|Device|Sublingual sufentanil tablet system|Usage of a new patient-controlled SSTS in the postoperative phase after laminectomy or spinal fusion.
15980022|NCT03036514|Drug|Patient-controlled intravenous analgesia|Usage of classically used patient-controlled intravenous mophine-based postoperative analgesia after laminectomy or spinal fusion.
15980023|NCT03036501|Drug|[^14C]-Risdiplam|[^14C]-Risdiplam 18 mg oral solution with approximately 0.75 megabecquerel MBq (20 microcuries [μCi]) of [14C]-labeled Risdiplam.
15980024|NCT03036488|Biological|Pembrolizumab|On Day 1 of each cycle in the neoadjuvant and adjuvant phases of the study for a total of 17 cycles; intravenous (IV) infusion.
15980025|NCT03036488|Drug|Carboplatin|On Day 1 of Cycles 1-4 of the neoadjuvant phase of the study OR on Days 1, 8, 15 of Cycles 1-4 of the neoadjuvant phase of the study; IV infusion.
15980026|NCT03036488|Drug|Paclitaxel|On Days 1, 8 and 15 of Cycles 1-4 in the neoadjuvant phase of the study; IV infusion.
15980027|NCT03036488|Drug|Doxorubicin|On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV injection.
15980028|NCT03036488|Drug|Epirubicin|On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV injection.
15980029|NCT03036488|Drug|Cyclophosphamide|On Day 1 of Cycles 5-8 of the neoadjuvant phase of the study; IV infusion.
15980030|NCT03036488|Drug|Placebo|normal saline solution or dextrose: On Day 1 of each cycle in the neoadjuvant and adjuvant phases of the study for a total of 17 cycles; IV infusion
15980031|NCT03036488|Biological|Granulocyte colony stimulating factor: Filgrastim or Pegfilgastrim|For prevention of neutropenia, filgrastim 5 μg/kg/day via subcutaneous (SC) injection administered per standard of care after chemotherapy OR pegfilgastrim 100 µg/kg (individualized) or 6 mg (general approach) via SC injection administered per standard of care.
15980032|NCT03036475|Device|Sienna+ injection|Subcutaneous injection of Sienna+ in the morning of operation day
15980033|NCT03036462|Drug|Iron|i.v. iron administration
15980034|NCT03036462|Drug|Saline|i.v. NaCl administration
15980035|NCT03036449|Behavioral|Education program for NICU caregivers.|"Intervention includes a main initial educational program, maintenance education programs and tools supply
~- Main educational program will include 9 hours of courses into NICU (1 hour each week) and @ learning modules validation.
~Topics: Main causes of medication errors, How to analyse retrospectively medication errors, Strategies to reduce medication errors, How to improve communication between health professional; Task interruption; Standardisation of preparation…..
~Maintenance education program will return on specific topics of main program and will be fitted to each NICU needs.
~Examples of Tools: check lists, medication neonatal formulary, Sound alike and Look alike drug lists…"
15980036|NCT03036436|Behavioral|Intervention|A physical activity intervention, delivered remotely using a combination of the Fitbit application and support from a chartered physiotherapist.
15980037|NCT03036423|Behavioral|Online video education|
15980038|NCT03036423|Behavioral|Computerized mental exercises|
15980039|NCT03036410|Device|standard telephone setting|without streaming function
15980040|NCT03036410|Device|DECT|cordless telephone (streaming to both hearing devices)
15980041|NCT03036410|Device|EasyCall|accessories for Bluetooth capable mobile telephones (streaming to both hearing devices)
15980042|NCT03036410|Device|DuoPhone|streaming function, which provides the speech signal to both ears
15980043|NCT03036384|Drug|HB Prilocaine 2% (varying dose)|Varying dose of hyperbaric (HB) prilocaine 2% according to sensitive response of previous subjects. The dose of hyperbaric prilocaine 2% will be administrated intrathecally with 100µg of morphine and 2.5µg of sufentanyl
15980044|NCT03036384|Drug|HB Prilocaine 2%|The dose of 45mg of hyperbaric (HB) prilocaine 2% will be administrated intrathecally with 100µg of morphine and 2.5µg of sufentanyl
15980045|NCT03036384|Drug|Sufentanil|2.5µg sufentanyl
15980046|NCT03036384|Drug|Morphine|100 µg Morphine
15980047|NCT03036371|Behavioral|High Intensity Interval Exercise|6 week at-home aerobic exercise protocol
15980048|NCT03036358|Other|teledermatology consult|Information from the dermatologic assessment will be entered into the patients chart.
15980049|NCT03036358|Other|Routine Care|The dermatologic assessment will occur but not added to the patients medical record. Dermatology may still be consulted but will be at the prerogative of the treating hospitalist.
15980050|NCT03036345|Device|Dual-monitoring|Monitored using both INVOS and FORE-SIGHT monitors.
15980051|NCT03036332|Behavioral|Aerobic interval training|Carried out 3 times per week for 16 weeks
15980052|NCT03036319|Device|Active tDCS|Participants will receive active tDCS at up to 4mA per electrode for up to 40 minutes for up to 260 sessions.
15980053|NCT03036319|Device|Sham tDCS|Participants will receive sham tDCS for up to 260 sessions
15980054|NCT03036319|Behavioral|Cognitively based intervention|Participants may receive a cognitively based intervention that targets the particular cognitive and/or functional abilities of interest. This includes methods of cognitive training, cognitive remediation, and cognitive rehabilitation for up to 260 sessions
15980055|NCT03036319|Device|Active tACS|Participants will receive active transcranial alternating current stimulation at up to 4mA per electrode for up to 40 minutes for up to 260 sessions
15980056|NCT03036319|Device|Sham tACS|Participants will receive sham transcranial alternating current stimulation for up to 260 sessions
15980057|NCT03036319|Device|Active tRNS|Participants will receive active transcranial random noise stimulation at up to 4mA per electrode for up to 40 minutes for up to 260 sessions
15980061|NCT03036293|Drug|Tenoten|Tablet for oral use.
15980063|NCT03036267|Behavioral|BREATHE|Primary care providers (PCPs) randomized to BREATHE will be trained to deliver the 7-minute brief shared decision-making intervention using a 4-step motivational interviewing approach.
15980064|NCT03036267|Other|Attention Control Condition|PCPs randomized to the control intervention will not receive any specific training. To control for contact, they will be instructed to engage in a 7-minute diet and exercise discussion as this will not confound results.
15980065|NCT03036254|Device|HBOT intervention|"HBOT is a treatment in which oxygen-enriched air (up to 100%) is administered to patients at a pressure.
~HBOT intervention arm - 3 months of HBOT treatment, 9 months observation
~all participants receive HBOT treatment for 3 months at year 2"
15980066|NCT03036254|Device|Sham intervention|"Sham was selected as the control condition rather than usual care to equate intervention groups with respect to other variables that could influence cognition and functional status, such as a new challenge (completing an activity program), peer socialization, and attention from staff."
15980067|NCT03036241|Device|Conventional angioplasty|Angioplasty with conventional balloon
15980068|NCT03036241|Device|Angioplasty with drug-eluting balloon|Angioplasty with drug-eluting balloon
15980069|NCT03036228|Drug|Karonudib|Dose escalation of administration with Karonudib.
15980070|NCT03036215|Behavioral|PACT Experimental Arm|The study will employ a self-management program, entitled Personalized Activated Care and Training (PACT) that is a tailored 8-week progressive web-based training program supported by a health coach to enhance understanding, compliance, and success in improving TMD pain. The program provides 8 weeks of structured didactic and experiential training on exercises and cognitive- behavioral training to reduce risk factors that contribute to delayed recovery and enhance protective factors that have evidence of improving TMD pain.
15980071|NCT03036202|Drug|Epinephrine|This is truly an observational study to determine T1/2 for epinephrine and time to peak concentration following a single dose of epinephrine in a cardiac arrest setting
15980072|NCT03036189|Behavioral|baa nnilah|7 meetings in the community led by a trained community facilitator
15980073|NCT03036176|Behavioral|Play-based family centered stimulation|Children in the intervention group received routine medical treatment and nutritional rehabilitation services in hospital; their primary caregivers were given basic orientations on child care, feeding and nutrition. Children attended play-based stimulation sessions in which trained nurses demonstrated caregivers on how to stimulate the SAM child using play materials and facilities at playroom and playground of the hospital. After discharge from hospital, they were followed up at home and visited three times over a period of six months. During the visits, new play materials were provided and caregivers were shown how to use them to stimulate the SAM child.
15980074|NCT03036176|Other|no intervention|On the other hand, the control SAM group did not receive the guided psychomotor/psychosocial stimulation services although they had access to the playground facilities. Both the intervention and the control groups received all the routine medical care and dietary rehabilitation services at the hospital.
15980075|NCT03036163|Drug|PBTZ169 - 40 mg|40 mg of PBTZ169 (1 capsule) orally once in fasting state
15980076|NCT03036163|Drug|PBTZ169 - 80 mg|80 mg of PBTZ169 (2 capsules 40 mg) orally once in fasting state
15980077|NCT03036163|Drug|PBTZ169 - 160 mg|160 mg of PBTZ169 (4 capsules 40 mg) orally once in fasting state
15980078|NCT03036163|Drug|PBTZ169 - 320 mg|320 mg of PBTZ169 (8 capsules 40 mg) orally once in fasting state
15980079|NCT03036163|Drug|PBTZ169 - 640 mg|640 mg of PBTZ169 (16 capsules 40 mg) orally once in fasting state
15980080|NCT03036163|Drug|PBTZ169 - 320 mg (multiple administration)|320 mg of PBTZ169 (8 capsules 40 mg) orally once per day in fasting state for 14 days
15980081|NCT03036163|Drug|PBTZ169 - 640 mg (multiple administration)|640 mg of PBTZ169 (16 capsules 40 mg) orally once per day in fasting state for 14 days
15980082|NCT03036150|Drug|Dapagliflozin|10 mg or 5 mg tablets given once daily, per oral use.
15980083|NCT03036150|Drug|Placebo|Placebo matching dapagliflozin 10 mg or 5 mg
15980084|NCT03036137|Device|Transcranial Direct Current Stimulation|Anodal stimulation of the temporoparietal left area with an cathode over the right dorsolateral prefrontal cortex. Stimulation will be applied for 20 minutes at 2 mA.
15980085|NCT03036137|Device|Sham Transcranial Direct Current Stimulation|Sham tDCS sessions will last 20 minutes
15980086|NCT03036124|Drug|Dapagliflozin|10 mg or 5 mg tablets given once daily, per oral use.
15980087|NCT03036124|Drug|Placebo|Placebo matching dapagliflozin 10 mg or 5 mg.
15980088|NCT03036111|Drug|Trimebutine|Trimebutine suppository will be inserted in the anal canal on completion of hemorrhoidectomy then at six and 12 hours postoperatively.
15980089|NCT03036111|Procedure|Hemorrhoidectomy|Patients will undergo classic Milliagn-Morgan hemorrhoidectomy
15980095|NCT03036085|Drug|Liposomal bupivacaine|In the operating room after induction of general anesthesia patients will be positioned in a lateral decubitus position, prepared and draped in a sterile fashion. Under thoracoscopic guidance, a posterior intercostal nerve block will be performed with liposomal bupivacaine plus normal saline.
15980096|NCT03036085|Drug|Bupivacaine|In the operating room after induction of general anesthesia patients will be positioned in a lateral decubitus position, prepared and draped in a sterile fashion. Under thoracoscopic guidance, a posterior intercostal nerve block will be performed with bupivacaine plus epinephrine plus normal saline.
15980097|NCT03036085|Drug|Epinephrine|In the operating room after induction of general anesthesia patients will be positioned in a lateral decubitus position, prepared and draped in a sterile fashion. Under thoracoscopic guidance, a posterior intercostal nerve block will be performed with bupivacaine plus epinephrine plus normal saline.
15980098|NCT03036085|Drug|Normal saline|In the operating room after induction of general anesthesia patients will be positioned in a lateral decubitus position, prepared and draped in a sterile fashion. Under thoracoscopic guidance, a posterior intercostal nerve block will be performed with liposomal bupivacaine plus normal saline or with bupivacaine plus epinephrine plus normal saline.
15980099|NCT03036072|Other|Strict normothermia|
15980100|NCT03036072|Device|Delayed Rewarming|Use of the servo-controlled cooling blanket for delayed rewarming to target temperature.
15980101|NCT03036059|Drug|400 μg/kg Ivermectin + 400 mg Albendazole|400ug/Kg, tablet, given orally once or twice a year.
15980102|NCT03036046|Drug|F901318 with fluconazole low dose|adverse events
15980103|NCT03036046|Drug|F901318 with fluconazole high dose|adverse events
15980104|NCT03036046|Drug|F901318 with posaconazole|adverse events
15980105|NCT03036033|Device|SaeboGlove|All participants are given a Saebo glove to use during their stroke recovery.
15980106|NCT03036020|Radiation|CereTom Neurologica Samsung|Diagnosis of acute stroke patients by cerebral CT diagnostics prehospital
15980107|NCT03036007|Other|Prescribed Physical Activity|General physical activity prescribed by a physiotherapist
15980108|NCT03036007|Other|Exercises with Internet support|Neck-specific exercise with Internet support
15980109|NCT03035994|Other|Real-Time Biofeedback|A custom written MatLab script will sample bilateral peak vertical ground reaction forces and display the magnitude in real time on a screen placed in front of the participant. A target line will be placed in the middle of the screen which corresponds to one of the three loading conditions. Participants will be instructed to alter their movement in an attempt to match each limb's vertical ground reaction force to the target line.
15980110|NCT03035981|Other|White rice, low amylose|White and brown rice were tested for differences in gastric emptying rate and appetitive response
15980111|NCT03035981|Other|White rice, high amylose|White and brown rice were tested for differences in gastric emptying rate and appetitive response
15980112|NCT03035981|Other|White rice, slow|White and brown rice were tested for differences in gastric emptying rate and appetitive response
15980113|NCT03035981|Other|White rice, resistant|White and brown rice were tested for differences in gastric emptying rate and appetitive response
15980114|NCT03035981|Other|Brown rice, low amylose|White and brown rice were tested for differences in gastric emptying rate and appetitive response
15980115|NCT03035981|Other|Brown rice, high amylose|White and brown rice were tested for differences in gastric emptying rate and appetitive response
15980116|NCT03035981|Other|Fructooligosaccharide (FOS)|White and brown rice were tested for differences in gastric emptying rate and appetitive response
15980117|NCT03035968|Other|Vojta therapy|
15980118|NCT03035968|Other|conventional physiotherapy|
15980119|NCT03035955|Drug|Azelaic acid|15% gel twice daily for four weeks to one side of face
15980120|NCT03035942|Drug|Dexamethasone|Dexamethasone 8 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.
15980121|NCT03035942|Drug|Ondansetron|Ondansetron 4 mg (made up to 5 mL with normal saline) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.
15980122|NCT03035942|Drug|Saline|Normal saline (5 mL total volume) will be drawn into each syringe which will be offered to the anesthesia provider after the opaque envelope was opened and administered immediately after spinal anesthesia was performed.
15980123|NCT03035929|Drug|Dexamethasone|A single dose of dexamethasone IV 4 mg will be administered.
15980124|NCT03035916|Other|Transversus abdominis plane block|Participants in this group receive ultrasound-guided TAP block under bilateral costal margin with multiple injections of 40ml 0.375% ropivacaine after the induction of general anesthesia, 30 minutes later the surgery will be started.
15980125|NCT03035916|Other|Epidural anesthesia|Participants in the Epidural group receive a epidural block (T8-9) with 2 mL of 1.6% lidocaine as a test dose before induction. After a successful placement of epidural catheter, the block then is established with 5 mL of 0.375% ropivacaine and continous infusion of 0.375% ropivacaine(5 mL/h) during the surgery.
15980126|NCT03035916|Other|control|The Control group receives standard IV-inhaled general anesthesia.
15980127|NCT03035903|Device|Not holding, then holding the MedGem®|Subjects will have a RMR measurement taken first while not holding the MedGem®, and then while holding the MedGem®
15980128|NCT03035903|Device|Holding, then not holding the MedGem®|Subjects will have a RMR measurement taken first while holding the MedGem®, and then while not holding the MedGem®
15980129|NCT03035890|Radiation|Radiation|Radiation therapy will be administered in 3 or 5 fractions over 3-10 days, at a recommended dose of 8-15 Gy per fraction for 3 total fractions (total dose 24-45 Gy) or 6-10 Gy per fraction for 5 total fractions (total dose 30-50 Gy)
15980130|NCT03035890|Drug|Immuno-Therapeutic Agent|"Immune checkpoint inhibitors that are FDA approved for use in patients with metastatic NSCLC will be acceptable for use concurrently with radiotherapy in this trial. The choice of agents will be at the treating medical oncologist's discretion, and include:
~Nivolumab 240mg or 3 mg/kg once every 2 weeks (14 day cycle)
~Pembrolizumab 200mg or 2 mg/kg once every 3 weeks (21 day cycle)
~Atezolizumab 1200 mg once every 3 weeks (21 day cycle)
~These agents should be continued per standard of care until either disease progression or unacceptable toxicity."
15980131|NCT03035877|Behavioral|Multisystemic Therapy-Emerging Adults|MST-EA is a home- and community-based treatment for emerging adults (ages 17-21) that aims to address antisocial behavior and problems caused by substance use disorders. The model also addresses co-occurring mental health problems when present. Therapists work directly with the young adult and his/her social network. This treatment also involves the use of coaches who help young people develop skills for young adulthood.
15980132|NCT03035877|Behavioral|Enhanced Treatment as Usual|With Enhanced Treatment as Usual (E-TAU), emerging adults will get the treatments that they usually receive when they have a substance use disorder and have been in trouble with the law. In addition, they will receive travel vouchers for attending services, a card with an individualized list of contacts when in crisis, and facilitation with identifying need of services and accessing those services.
15980133|NCT03035864|Drug|rhNGF|Eye Drop 20 μg/mL
15980134|NCT03035864|Other|Vehicle|Vehicle Eye Drop
15980135|NCT03035851|Behavioral|Aerobic exercise|
15980136|NCT03035851|Behavioral|Stretch and Strength|
15980137|NCT03035838|Drug|Fosaprepitant|Within 24 hours from injury, IVAMEND (the intravenous formulation of the NK-1 antagonist fosaprepitant) will be administered at a dose of 300 mg, intravenously over 1 hour.
15980368|NCT03034252|Procedure|Patients with Liposarcoma|Evaluation of Liposarcoma treated in a single center
15980138|NCT03035825|Dietary Supplement|Oral moisturizing jelly|Gel-based artificial saliva is an edible non-nutritious gel intended to relieve dry mouth
15980139|NCT03035825|Other|Artificial saliva|A non-edible oral lubricating gel for dry mouth patients
15980140|NCT03035812|Drug|Alkali|Oral intake of alkali therapy whatever the formulation (alkali-based water, powder or pharmaceutics)
15980141|NCT03035799|Other|Paleolithic diet|Paleolithic diet
15980142|NCT03035799|Other|General Healthful Diet|General Healthful Diet
15980143|NCT03035773|Behavioral|Care Plan Only|Patient participants randomized to Arm A will be sent a copy of the SCP within 3 months of completion of treatment and a copy will be added to their medical record. A copy of the SCP will also be sent to the PCP on record. The SCP will be completed by a nurse, nurse practitioner, or physician assistant. The SCP will be accompanied by a cover letter that will be signed by a member of the clinical team.
15980144|NCT03035773|Behavioral|Care Plan During a Visit|Patient participants randomized to Arm B will receive a copy of the SCP during an in-person 'stethoscope free' visit with a nurse, nurse practitioner, or physician assistant. A copy of the SCP will be added to the medical record and a copy will be sent to the primary care provider on record. The visit will be scheduled after consent is signed and will occur between 1 and 3 months after completion of treatment. The visit will focus on review of the SCP content and offer an opportunity for patients to ask questions about any aspect of the plan or associated treatment and survivorship issues.
15980145|NCT03035773|Behavioral|Care Plan During a Visit with an Additional Visit|Participants randomized to Arm C will receive a copy of the SCP during an in-person 'stethoscope free' visit with a nurse, nurse practitioner, or physician assistant. A copy of the SCP will be added to the medical record and a copy will be sent to the primary care provider. The visit will be scheduled after consent is signed and will occur between 1-3 months after completion of treatment. The initial visit will focus on review of the SCP content and offer an opportunity for patients to ask questions about any aspect of the plan or associated treatment and survivorship issues. Patients will also receive a follow up survivorship visit 7-10 months after the end of treatment that will focus on a review of the SCP and offer the opportunity to ask about any persistent or emerging issues.
15980146|NCT03035760|Drug|Oxfendazole|methyl-5 (6)-phenylsulfiyl-2-benzimidazole carbamate, is a broad spectrum benzimidazole antihelminthic. It is the sulphoxide metabolite of fenbendazole.
15980147|NCT03035747|Procedure|conventional surgery|high ligation and stripping of incompetent saphenous veins
15980148|NCT03035747|Procedure|endovenous laser ablation|endovenous laser ablation of incompetent saphenous veins
15980149|NCT03035747|Procedure|sclerotherapy|ultrasound guided or catheter or or any other methods sclerotherapy of incompetent saphenous or varicose veins
15980150|NCT03035747|Procedure|endovenous radiofrequency ablation|endovenous radiofrequency ablation of incompetent saphenous veins
15980151|NCT03035747|Procedure|phlebectomy|hooks phlebectomy of varicose veins
15980152|NCT03035734|Drug|BMS-986141 Form A Tablet|tablet
15980153|NCT03035734|Drug|BMS-986141 Form B tablet (low dose)|tablet
15980154|NCT03035734|Drug|BMS-986141 Form B tablet (high dose)|tablet
15980155|NCT03035721|Dietary Supplement|Low protein formula|Infants were enrolled to receive low protein formula (energy: 65 kcal/100 mL, protein: 1.2 g/100 mL, protein-to-energy ratio:1.9 g/100 kcal, carbohydrates: 8 g/100 mL, fat: 3.1 g/100 mL) for the firsts 4 months of life.
15980156|NCT03035721|Dietary Supplement|Standard protein formula|Infants were enrolled to receive standard protein formula (energy: 68 kcal/100 mL, protein: 1.7 g/100 mL, protein-to-energy ratio:2.5 g/100 kcal, carbohydrates: 7.1 g/100 mL, fat: 3.5 g/100 mL) for the firsts 4 months of life.
15980157|NCT03035708|Drug|Varenicline|1 mg BID
15980158|NCT03035708|Drug|Placebo oral capsule|1 mg BID
15980159|NCT03035695|Device|Axiostat®|
15980160|NCT03035695|Device|Cotton Gauze|
15980161|NCT03035682|Other|Augmented Media Group|The intervention group will receive traditional PT services deemed clinically appropriate via examination plus home exercise prescription augmented via a mobile health application. The augmented media group will receive digital exercise prescription via a mobile health application source (Physitrack) that includes: high definition video and pictures, education material and written instruction, reminder notification and in-app logging of completion.
15980162|NCT03035682|Other|Traditional Group|The Traditional Group will receive traditional PT services deemed clinically appropriate via examination plus traditional home exercise prescription.
15980163|NCT03035669|Behavioral|Mindfulness group|8 week program
15980164|NCT03035669|Behavioral|Reading group|8 week program
15980165|NCT03035656|Drug|Ropivacaine|Administration of Ropivaciane via epidural injection intra-operatively
15980166|NCT03035656|Other|Saline|Administration of saline via epidural injection intra-operatively
15980167|NCT03035643|Device|AMDS|The device will be implanted during an already planned surgical intervention for aortic dissection repair. The participant will be observed and data gathered during the surgery and routine standard of care follow up visits.
15980168|NCT03035630|Drug|Avelumab|Avelumab 10mg/kg IV over 60 minutes on D1 and D15 of every 28 day cycle
15980169|NCT03035630|Drug|Sunitinib|Sunitinib 50 mg once daily from D1 to D14 of every 21 day cycle
15980170|NCT03035617|Drug|Bupivacaine|Bupivacaine is long acting local anesthetic drug. Though minimum toxic dose of bupivacaine for intra-peritoneal use is not defined, analgesic effect of its intra-peritoneal use especially after laparoscopic cholecystectomy has been assessed in several interventional studies. Intra-peritoneal use of up to 50ml of .25% , , or up to 20ml of .5% solution has not shown any drug related adverse reactions .
15980171|NCT03035617|Other|Saline|In control arm mesh will be soaked in normal saline solution as is routinely done.
15980172|NCT03035604|Other|Comprehensive Geriatric Assessment|Undergo nutritional geriatric assessment
15980173|NCT03035591|Drug|ODM-207|
15980174|NCT03035578|Drug|Morphine|Sampling blood for development of Morphine Pharmacokinetic/Pharmacodynamic Model for Neonatal Population
15980175|NCT03035578|Drug|Morphine|Sampling saliva for development of Morphine Pharmacokinetic/Pharmacodynamic Model for Neonatal Population
15980176|NCT03035565|Behavioral|Computerized Cognitive Training with Brain HQ|Computerized Cognitive Training Brain HQ activities initiated and continued 1 hour/day, 5 days/week for 8 weeks
15980177|NCT03035565|Behavioral|Computerized Crossword Puzzles|Computerized Crossword Puzzles activities initiated and continued 1 hour/day, 5 days/week for 8 weeks
15980178|NCT03035552|Behavioral|Pacifier activated music player|Therefore the immediate goal of the current proposal is to demonstrate that intensive NNS-training using reinforcement with mother's voice can improve the oral feeding outcomes of infants with CCHD using a randomized controlled trial (RCT) design, with wait-list controls to ensure that infants in the trial all benefit from a treatment with only demonstrated positive effects. Establishment of optimal NNS patterns in the first 6 months after birth in these infants will improve downstream feeding skills and may promote better motor and language outcomes by one year of age.
15980179|NCT03035539|Other|Cardiac rehabilitation|AF specific cardiac rehabilitation Group education 1 hour each week for 3 months Physical training 1 hour each week for 3 months with physiotherapist
15980180|NCT03035539|Other|Standard treatment|Standard treatment
15980181|NCT03035513|Other|Continuous spikes and waves during slow sleep (CSWS)|
15980182|NCT03035500|Other|Educational Intervention|Receive health education
15980183|NCT03035500|Other|Laboratory Biomarker Analysis|Correlative studies
15980184|NCT03035500|Other|Long-term Follow-up|Undergo long-term follow-up using survivorship care plan
15980185|NCT03035500|Other|Quality-of-Life Assessment|Ancillary studies
15980186|NCT03035500|Other|Questionnaire Administration|Ancillary studies
15980187|NCT03035487|Device|Ultrasound guided prostate exam using SOC ultrasound system|
15980188|NCT03035487|Device|mpMRI guided prostate examination using PI-RADS v2|mpMRI guided prostate examination using standard of care MRI system
15980189|NCT03035487|Device|High-resolution micro-ultrasound guided prostate biopsy|
15980190|NCT03035474|Other|Digital Engagement|Patient engagement to improve self-management/medication adherence
15980191|NCT03035474|Other|Direct Engagement|Health system engagement to improve local QI programs
15980192|NCT03035448|Behavioral|Questionnaires|"Participants complete 3 assessment questionnaires during an already-scheduled office visit. These questionnaires should take about 9 minutes to complete.
~Participant completes 3 questionnaires after watching the second video about whether they think 1 of the videos was better than the other, and about their attitude toward psychology services. These questionnaires should take about 4 minutes to complete."
15980193|NCT03035448|Other|Video Presentation|Participant watches 2 videos showing actors playing a doctor, counselor, and patient, discussing psychology service options.
15980194|NCT03035435|Other|fast-track rehabilitation|
15980195|NCT03035435|Other|standard care rehabilitation|
15980196|NCT03035422|Drug|Sequential Packaging (SET)|"Sequential chemotherapy:
~Thiotepa 5 mg / kg / day for 1 day (D-13)
~Cyclophosphamide 400 mg / m² / day for 4 days (J-12 to J-9)
~Etoposide 100 mg / m² / day for 4 days (J-12 to J-9) Repos days J-8 and J-6 Reduced-intensity conditioning (RIC)
~Fludarabine 30 mg / m² / day for 5 days (J-5 to D-1)
~Busulfan IV 3.2 mg / kg / day for 2 days (J-5 and J-4)
~Anti-lymphocyte serum (Thymoglobuline) 2.5 mg / kg / day for 2 days (J-3 and J-2)"
15980197|NCT03035422|Drug|Transfusion graft|Graft of peripheral stem cells is preferred at D0
15980198|NCT03035422|Drug|Prevention of GVHD|"Cyclophosphamide 50mg / kg / day on days D + 3 and D + 5
~Cyclosporine A (CSA; 3 mg / kg / day IV from D + 6)
~Mycophenolate mofetil (MMF; 30 mg / kg / day, maximum x2 1g / day from day J + 6)"
15980199|NCT03035422|Drug|Care supports|According to the protocols of each center
15980200|NCT03035422|Drug|Lymphocyte injection of prophylactic donor (PDLI)|"According to the protocols of each center. In the absence of clinical indication against-disease (GVHD), phasing MMF between days D + 35 and D + 56, then phasing APF between D + 62 and D + 90
~- PDLI: 3 injections from the D + 120 patients who discontinued immunosuppressive therapy for ≥ 1 month and having no active GVHD or history of acute GVHD grade> II"
15980201|NCT03035409|Drug|Anamorelin Hydrochloride|Given PO
15980202|NCT03035409|Behavioral|Exercise Intervention|Undergo physical activity
15980203|NCT03035409|Other|Laboratory Biomarker Analysis|Correlative studies
15980204|NCT03035409|Other|Nutritional Assessment|Undergo nutritional counseling
15980205|NCT03035409|Other|Quality-of-Life Assessment|Ancillary studies
15980206|NCT03035409|Other|Questionnaire Administration|Ancillary studies
15980207|NCT03035396|Device|Diassess Influenza A and B Test|
15980208|NCT03035383|Procedure|Purse string technique|Thyroidectomy closure is performed using purse string suturing technique.
15980209|NCT03035383|Procedure|Conventional technique|Thyroidectomy closure is performed using conventional suturing technique.
15980210|NCT03035370|Biological|Viaskin PT 25 mcg|Two applications of Viaskin 25 mcg PT at a 2-week interval (D0 and D14).
15980211|NCT03035370|Biological|Viaskin PT 50 mcg|Two applications of Viaskin 50 mcg PT at a 2-week interval (D0 and D14).
15980212|NCT03035370|Biological|Viaskin PT Placebo|Two applications of Viaskin PT Placebo at a 2-week interval (D0 and D14).
15980213|NCT03035370|Biological|Boostrix™|Four weeks after the second Viaskin application (at Day 42 of the study), all subjects will receive a dose of diphtheria-tetanus-pertussis vaccine (Boostrix® dTpa) to ensure the optimal recall of their immunity against pertussis.
15980214|NCT03035357|Drug|Daratumumab|16 mg/kg by vein once weekly for a total of 4 doses.
15980215|NCT03035344|Other|Metabolome study|Metabolome study in ALL patients compared to healthy controls
15980216|NCT03035331|Procedure|Cryosurgery|Undergo cryosurgery
15980217|NCT03035331|Biological|Dendritic Cell Therapy|Given IT
15980218|NCT03035331|Other|Laboratory Biomarker Analysis|Correlative studies
15980219|NCT03035331|Biological|Pembrolizumab|Given IV
15980220|NCT03035331|Biological|Pneumococcal 13-valent Conjugate Vaccine|Given by injection
15980221|NCT03035331|Other|Quality-of-Life Assessment|Ancillary studies
15980222|NCT03035318|Device|DePuy Global® Anchor Peg Glenoid Instrumentation|Placement of glenoid component will be performed using DePuy Global® Anchor Peg Glenoid Instrumentation.
15980223|NCT03035318|Device|DePuy Global® Anchor Peg Instrumentation with SmartBone™|Placement of glenoid component will be performed using DePuy Global® Anchor Peg Instrumentation with SmartBone™.
15980224|NCT03035318|Device|IRI with SmartBone™|Placement of glenoid component will be performed using Intelligent Reusable Instrumentation (IRI) with SmartBone™.
15980225|NCT03035318|Device|RTI with SmartBone™|Placement of glenoid component will be performed using Real Time Instrumentation (RTI) with SmartBone™.
15980369|NCT03034239|Dietary Supplement|Protein supplementation|+ insect protein
15980226|NCT03035318|Device|IRI with SmartBase|Placement of glenoid component will be performed using Intelligent Reusable Instrumentation (IRI) with SmartBase.
15980227|NCT03035305|Dietary Supplement|Lipid-based Nutrient Supplement (LNS)|"For each round of SMC distribution (total of 4 rounds):
~For children aged 6-11 months: 15 sachets/month or 50g every two days for 4 weeks
~For children aged 12-59 months: 21 sachets/month or 50g per day for 3 weeks"
15980228|NCT03035305|Drug|Seasonal malaria chemoprevention|"For each round of SMC distribution (total of 4 rounds):
~For children aged 6-11 months: sulfadoxine 250mg/pyrimethamine 12.5mg and amodiaquine 75mg
~For children aged 12-59 months: sulfadoxine 500mg/pyrimethamine 25mg and amodiaquine 150mg
~D1 : 1 tablet sulfadoxine-pyrimethamine + 1 tablet amodiaquine D2 : 1 tablet amodiaquine D3 : 1 tablet amodiaquine"
15980229|NCT03035279|Drug|SC-006|Intravenous
15980230|NCT03035279|Drug|ABBV-181|Intravenous
15980231|NCT03035266|Other|Blood Flow Restriction|Delfi's Personalized Tourniquet System for Blood Flow Restriction has been specifically designed to safely regulate and control tourniquet pressure. Occlusion pressures will be set at 80% of total occlusive pressure as determined by the Doppler sensor. Each subject will perform 4 sets of each exercise (1 set of 30 repetitions followed by 3 sets of 15 repetitions). The pressure will remain through completion of the final set, but not to exceed 5 minutes. One minute rest without tourniquet application will be performed between 5 minute cycles. Sets and repetitions will remain constant for each subject; however, resistance will be incrementally increased after the subject is able to complete all 75 repetitions without loss of proper form.
15980232|NCT03035266|Other|Standard rehabilitation|Standard of care for post-operative condition
15980233|NCT03035253|Drug|OMP-305B83|
15980234|NCT03035253|Drug|FOLFIRI|Treatment will consist of OMP-305B83 and the FOLFIRI chemotherapy regimen.
15980235|NCT03035253|Drug|FOLFOX|Treatment will consist of OMP-305B83 and the FOLFOX chemotherapy regimen.
15980236|NCT03035240|Behavioral|Financial Education|Participants randomized to financial education will undergo a year long financial education. This involves 9 weeks of weekly classes followed by one on one coaching for a year.
15980237|NCT03035227|Procedure|Catheter Ablation|Catheter ablation of atrial or ventricular arrhythmia. The technique and type of ablation will be at the discretion of the treating electrophysiologists.
15980238|NCT03035227|Drug|Anti-Arrhythmics|Anti-Arrhythmic drugs that are deemed to be appropriate for the given participants's arrhythmia by the treating physician.
15980239|NCT03035214|Drug|Dexamethasone (Steroids)|Is to describe the use of integrated assessment of respiratory physiology using Targeted Neonatal Echocardiography, assessment of optimal Functional Residual Capacity and the tolerance of lung oxygen uptake at different oxygen levels, and hence early prediction of Bronchopulmonary Dysplasia and the underlying pathophysiology by periodic application of the oxygen tolerance test; which may help early targeted treatment of this common disease.
15980240|NCT03035188|Drug|Vismodegib|1 capsule (150 mg vismodegib) taken once daily for a maximum of 12 weeks.
15980241|NCT03035175|Other|Video Laryngoscopy|Residents intubate using video laryngoscopy.
15980242|NCT03035175|Other|Traditional Laryngoscopy|Residents intubate without using video laryngoscopy.
15980243|NCT03035162|Device|Transcranial direct current stimulation|Dual Active/sham tDCS will be applied over the leg motor area (M1) priori to conventional physical therapy (1 hours). Anodal on affected hemisphere, Cathodal on unaffected hemisphere. Each participant will complete two experiments (active/sham tDCS). The interval between two experiments is at least 48 hours. The two experiments will be performed in random order for each subject.
15980244|NCT03035149|Other|Weight Management Program|Obese subjects partake in a medically supervised weight management program. This lifestyle modification program involves weekly three hour sessions for six months and monthly sessions for six months. The first twelve weeks comprise an initial weight loss phase when patients are placed on a 900 Kcal/day meal replacement. This is followed by a four week transition to a 1200-1800 Kcal diet followed by a ten week maintenance phase of 10 weekly sessions.The majority of weight loss occurs during the first 26 weeks followed by a 26 week period of stabilization of weight loss. Hence subjects are evaluated after the first 26 weeks.
15980245|NCT03035123|Behavioral|Therapeutic education|Interventional arm
15980246|NCT03035110|Behavioral|Dialectical Behavioural Therapy (DBT) based skills groups|Dialectical Behavioural Therapy (DBT) involves skills that help people manage their emotions and tolerate distress. This therapy is found effective in reducing self-harm behaviour for outpatients with Borderline Personality Disorder.
15980247|NCT03035097|Other|Biorepository|One-time blood draw for blood to be stored in a biorepositoy
15980248|NCT03035084|Drug|Vitamin D3|Single oral dose of 50,000 IU of vitamin D3
15980249|NCT03035084|Drug|Vitamin D2|Single oral dose of 50,000 IU of vitamin D2
15980250|NCT03035084|Drug|Placebo oral capsule|Placebo oral capsule
15980251|NCT03035071|Procedure|minimally invasive esophagectomy|In the MIE group the laparoscopic procedure was performed for gastric tube formation. The patient was placed in supine position with legs apart. The surgeon stands between the legs using a five-trocar technique. Laparoscopy will be followed by an anterolateral thoracotomy in the fourth intercostal space.
15980252|NCT03035071|Procedure|open esophagectomy|in the open group the gastric mobilization and gastric tube formation will be perfumed with an open surgical approach. Laparotomy will be performed, followed by an anterolateral thoracotomy in the fourth intercostal space.
15980253|NCT03035058|Drug|Vedolizumab|Vedolizumab intravenous infusion
15980254|NCT03035058|Drug|Placebo|Placebo
15980255|NCT03035045|Drug|Paracetamol|
15980256|NCT03035045|Drug|Placebo Oral Tablet|
15980257|NCT03035032|Drug|Leuprolide|Subcutaneous Injection
15980258|NCT03035019|Behavioral|Lantern|This pilot will evaluate how the availability of a virtual stress management resource can help patients reduce anxiety and improve quality of life.
15980259|NCT03035006|Drug|Lipotecan|Lipotecan based concurrent chemoradiotherapy
15980288|NCT03034785|Device|FlexiMitt|The proposed research designs and fabricates a new technological innovation in wearable soft-sensors, called flexi-mitts, for measuring force modulation and joint angles of the hand (wrist and fingers) of toddlers.
15980289|NCT03034772|Drug|Dorzolamide-timolol|Topical eye drop (active comparator) used twice daily for study duration
15980290|NCT03034772|Other|Artificial tears|Topical eye drop (placebo comparator) used twice daily for study duration
15980260|NCT03034993|Behavioral|Text Messaging|"Subjects will receive text messages with reminders of their upcoming outpatient health care appointments at the Boston Health Care for the Homeless Program (BHCHP) clinic. The text message will indicate the time of the appointment and the location (e.g. Remember appointment Friday March 15 at 10am in the Yawkey building). Appointment reminder text messages will be sent 3 days ahead and again 1 day ahead of the appointment date. Medication related texts will be sent every other day and will be educational and motivational (e.g. Keep taking medications that way the doctor prescribed them, even if feeling fine). Mood related texts will also be sent every other day and ask about mood on a 1 to 5 scale. The participant will text back a response."
15980261|NCT03034980|Other|Training intensity (workload) during ergospirometry|The reached workload (W) during each training is noted during 12 weeks of rehabilitation. The relative intensity is expressed as a percentage of VT1 and VT2.
15980262|NCT03034967|Drug|Danirixin|Danirixin is available as 5, 10, 25, 35 and 50 mg white, film-coated, oval or round shaped tablets for oral administration.
15980263|NCT03034967|Drug|Danirixin matching placebo|Danirixin matching placebo will be available as white, film-coated, oval or round shaped tablets for oral administration.
15980264|NCT03034967|Drug|Standard of care|Participants will continue with their standard of care inhaled medications (i.e. long acting bronchodilators with or without inhaled corticosteroids) during the study treatment.
15980265|NCT03034967|Drug|Rescue medication|Participants will continue to use rescue medication(s). The following rescue medications may be used: short acting beta agonists, short acting muscarinic antagonists, or short acting combination bronchodilators.
15980266|NCT03034954|Device|Active HD-tDCS|Participants will receive active HD-tDCS at 3mA for 20 minutes
15980267|NCT03034954|Device|Sham HD-tDCS|Participants will receive sham HD-tDCS
15980268|NCT03034941|Drug|Metformin|In the metformin group metformin was initiated at a dose of 500 mg once per day and increased by 500 mg every 3 days up to 1000 mg twice per day per os for 12 weeks
15980269|NCT03034941|Drug|Liraglutide + metformin|In the COMBI group the initial dose of metformin was 500 mg for at least 2 wk and gradually increased to a final dose of 1000 mg twice per day. Liraglutide 1.2 mg once per day s.c. was added after first two weeks of monotherapy with metformin.
15980270|NCT03034928|Device|Contact lens with investigational coating 1|Contact lens with investigational coating 1 pre-cycled in OPTI-FREE® RepleniSH® Multi-Purpose Disinfecting Solution (MPDS)
15980271|NCT03034928|Device|Balafilcon A contact lens|Balafilcon A contact lens pre-cycled OPTI-FREE® RepleniSH® MPDS
15980272|NCT03034928|Device|OPTI-FREE® RepleniSH® MPDS|Multipurpose contact lens solution
15980273|NCT03034928|Device|Contact lens with investigational coating 2|Contact lens with investigational coating 2 pre-cycled in OPTI-FREE® RepleniSH® MPDS
15980274|NCT03034915|Drug|UMEC/VI 62.5/25 mcg via ELLIPTA|ELLIPTA DPI inhaler will contain two individual blister strips with 30 blisters per strip; the first strip contains umeclidinium bromide (62.5 mcg per blister) blended with lactose monohydrate and magnesium stearate and second strip contains vilanterol trifenatae (25 mcg per blister) blended with lactose monohydrate and magnesium stearate.
15980275|NCT03034915|Drug|UMEC 62.5 mcg via ELLIPTA|The ELLIPTA inhaler will contain one blister strip, which will have 30 blisters of umeclidinium bromide (62.5 mcg).
15980276|NCT03034915|Drug|Salmeterol 50 mcg via DISKUS|The DISKUS inhaler will contain one blister strip, which will have 60 blisters of salmeterol xinafoate (50 mcg). The DISKUS will provide a total of 60 doses (60 blisters) and will deliver, when actuated, the contents of a single blister strip.
15980277|NCT03034915|Drug|Placebo via ELLIPTA|Lactose dry powder will be administered using ELLIPTA for both treatment periods. ELLIPTA DPI inhaler will contain two individual blister strips with 30 blisters per strip; containing lactose dry powder.
15980278|NCT03034915|Drug|Placebo via DISKUS|Lactose dry powder will be administered using DISKUS for both treatment periods. The DISKUS inhaler will contain one blister strip, which will have 60 blisters of lactose dry powder. The DISKUS will provide a total of 60 doses (60 blisters) and will deliver, when actuated, the contents of a single blister strip.
15980279|NCT03034863|Behavioral|Safe Actions for Families to Encourage Recovery|A novel, 5-session intervention to enhance currently mandated VA suicide safety planning by involving family members to support its implementation. Incorporation of education about suicide risk factors and teaching communication skills of active listening and making a positive request will supply Veterans and family members with the knowledge and tools needed to 1) identify potential warning signs, and 2) discuss Veteran ideation or family concerns with assurance that such requests will be listened to with validation and support, creating an ally for the suicidal Veteran in his struggle. As discussed above, research has demonstrated compellingly that suicidal desire is motivated by two interpersonal factors; perceived burdensomeness and thwarted belongingness. SAFER aims to increase family support for the Veteran to directly mitigate Veteran loneliness and sense of being a burden to others.
15980280|NCT03034863|Behavioral|Treatment-as-Usual|The comparison condition will be an assessment-only enhanced treatment-as-usual (TAU).
15980281|NCT03034850|Procedure|CRS/HIPEC|The generic surgical approach involved peritonectomy procedures and visceral resections called CRS as described by Sugarbaker (1995). Peritoneal disease burden was assessed using the perito- neal cancer index (PCI), which scores 13 intra-abdominal sites on a scale of 0 (no disease) to 3 (lesion size > 5 cm), thus giving a range of possible scores from 0 to 39. The same team performed the surgical procedure of all included patients. Before connection to the patient, the circuit was filled with dextrose 5% (2 L/m2 body surface area) and warmed to 37°C.
15980282|NCT03034837|Drug|resin sealant|Sealing the occlusal surface of the included molars using the market product of SDI conseal f once.
15980283|NCT03034837|Drug|ART sealant|"Sealing the occlusal surface of the included molars using the market product of 3M ESPE KetacTM Molar Easymix glass ionomer cement once."
15980284|NCT03034824|Procedure|SRP+940±15 nm diode laser|In addition to Non-surgical periodontal treatment, the individuals diagnosed with Generalized Aggressive Periodontitis were applied the 940±15 nm diode laser.
15980285|NCT03034824|Procedure|SRP+Er,Cr:YSGG laser|In addition to Non-surgical periodontal treatment, the individuals diagnosed with Generalized Aggressive Periodontitis were applied the Er,Cr:YSGG laser.
15980286|NCT03034824|Procedure|Scaling and root planing (SRP)-Control|Only Non-surgical periodontal treatment
15980287|NCT03034811|Device|Persona Partial Knee system|Fixed bearing partial knee
15980370|NCT03034239|Other|Resistance training|Resistance exercise
15980291|NCT03034759|Other|individualized insulin sensitivity index (ISind)|"The new insulin sensitivity index, named SISP is calculated from data derived from insulin pump and glucose monitoring (CGM) uploads."
15980292|NCT03034746|Other|Physical activity (PA)|It will perform a program consist of 15 min of warm-up, 60 min of aerobic and resistance training, and 15 min of cool-down.
15980293|NCT03034746|Other|cognitive treatment (CT)|The cognitive stimulation group will received a rehabilitation program with multimodal repetitive stimulation in order to exercise and reinforce the cognitive skills of the participant to slow/prevent the decline. In particular the treatment will be focused on reorient the patient about his/her-self, his/her history and his/her environment, to improve the memory skill by teaching compensatory and restitutive strategies, to help the patient to the discussion about everyday life and in particular to the everyday problems
15980294|NCT03034733|Drug|Dexamethasone|intravenous dexamethasone, two groups: 0,15 mg/kg, 0,25 mg/kg
15980295|NCT03034733|Drug|Sodium Chloride, (24)NaCl 0,9%|intravenous placebo
15980296|NCT03034720|Behavioral|Collaborative Care|Intervention subjects will receive treatment from an MSW-trained care manager over the course of 6-months after randomization. Intervention team members will work collaboratively with primary care providers to link physical and mental health care longitudinally through outpatient follow-up and community rehabilitation. Intervention subjects and their families and collaborative team members will share information and deliberate treatment decisions with each other in order to develop an individually tailored treatment plan. Stepped, higher intensity care will be available for intervention subjects with recurrent symptoms. Stepped up care will include CBT booster sessions targeting post-concussive and related symptom comorbidity as well as psychopharmacologic assessment and treatment.
15980297|NCT03034707|Dietary Supplement|biotin|
15980298|NCT03034694|Other|teledermatology consult|teledermatology consult
15980299|NCT03034694|Other|Routine Care|The patient will undergo imaging but this report will not be put into the chart.
15980300|NCT03034681|Other|Physiotherapy technique: TENS|
15980301|NCT03034681|Other|Physiotherapy technique: Vojta Therapy|
15980302|NCT03034668|Dietary Supplement|CS16-003 Full dose|350 mg 'Rhodiola rosea L. & Rhaptonticum carthamoides extracts
15980303|NCT03034668|Dietary Supplement|CS16-003 Half dose|175 mg 'Rhodiola rosea L. & Rhaptonticum carthamoides extracts + maltodextrin 175 mg
15980304|NCT03034668|Dietary Supplement|Placebo|Maltodextrin: 350 mg
15980305|NCT03034655|Device|CDP|Vestibular rehabilitation using CDP
15980306|NCT03034655|Device|Mobile posturography|Vestibular rehabilitation using mobile posturography
15980307|NCT03034655|Other|10 sessions|Vestibular rehabilitation, ten sessions
15980308|NCT03034655|Other|5 sessions|Vestibular rehabilitation, five sessions
15980309|NCT03034642|Procedure|Bronchoscopy with bilateral bronchoalveolar lavages|Bronchoscopy with bilateral bronchoalveolar lavages
15980310|NCT03034629|Behavioral|Short-term aerobic exercise|One bout of moderate intensity exercise (75% of maximal predicated heart rate).
15980311|NCT03034616|Device|OLIVA device|"OLIVA device is a laparoscopic device with a standard handle and a tip built of 5 parallel razor blades enclosed by protective cap opened by a separate button.
~This device will enable to perform shallow slashes on the ovarian cortex following the grasping of the ovary without damaging other abdominal and pelvic organs"
15980312|NCT03034603|Dietary Supplement|Nutri-jelly with PEITC|Nutri-jelly with PEITC resulted from an addition of tested amount of PEITC, which was shown in animal model to delay cancer growth, into Nutri-jelly.
15980313|NCT03034603|Dietary Supplement|Nutri-jelly|Nutri-jelly is an edible nutritious gel for patients with chewing and swallowing difficulties. One milligram of Nutri-jelly contains approximately 1 kcal.
15980314|NCT03034590|Other|questionnaire|
15980315|NCT03034577|Drug|Sugammadex|Reversal of neuromuscular block Sugammadex dosage will be adjusted to body weight and PTC/TOF count at the time of reversal, and not administered until PTC at least 1. Dosage will be 4mg/kg if TOF = 0 and PTC ≥ 1; and 2 mg/kg if TOF ≥1.
15980316|NCT03034577|Drug|Neostigmine|Neostigmine 50 micrograms/kg coupled with atropine 20 micrograms/kg or glycopyrrolate 5 micrograms/kg, to a maximum dose of neostigmine of 5.0 mg. The neostigmine should not be administered until the TOF has at least 3 twitches present.
15980317|NCT03034564|Drug|Northera|
15980318|NCT03034564|Drug|Placebo Oral Tablet|
15980319|NCT03034551|Behavioral|Financial Incentive, Mobile Phone App, and Cellular Scale|Subjects will be provided a cellular-connected digital scale and will be offered $150 to use the app each day to log one daily self-weighing and one medication check-in. Medication check-ins consist of uploading daily photos of pills at the time of self-administration through the Wellth app. If a 2 lb or greater daily increase in weight, or a 5 lb weekly increase in weight is detected in any patient, a UMCPP physician or nurse will be alerted via automatic email and text. A physician or a nurse will then call the patient to assess the patient's symptoms. If there are increasing heart failure symptoms, the physician or nurse will suggest the patient see their doctor within the next 48 hours and will notify the patient's primary care physician and cardiologist.
15980320|NCT03034538|Drug|Zonegran|100mg
15980321|NCT03034538|Drug|Zonegran|200mg
15980322|NCT03034499|Procedure|Single-port sacrocolpopexy|Single-port sacrocolpopexy surgery for the repair of vaginal apex prolapse.
15980323|NCT03034499|Procedure|Multi-port sacrocolpopexy|Multi-port sacrocolpopexy surgery for the repair of vaginal apex prolapse.
15980324|NCT03034486|Drug|D930, D565|Period 1: D565 administered 1 time for one day/ Period 2: D930 administered 3 time per day for 9 days/ Period 3: D565(1 time per day) with D930(3 time per day) administered for 9days
15980363|NCT03034304|Drug|Ifosfamide|2g/m2/d, intravenous drip for 30min. Administration is conducted for continuous 5 days. After 4 weeks, the above cycle is repeated for 6 continuous cycles
15980364|NCT03034304|Drug|PD1 antibody|200 mg/every two weeks ,four weeks is a cycle. Subjects were treated with MASCT-I combined with PD1 antibody until disease progression, MASCT-I intolerance or study completion. If PD1 antibody intolerance occurs, MASCT-I therapy alone will continue. MASCT-I and PD1 antibody are adminnistered according to their respective drug cycle without interfering with each other.
15980365|NCT03034291|Dietary Supplement|Cacao 70%|Consumption for 8 weeks of 50 grams of chocolate per day with 70% cocoa solids.
15980366|NCT03034291|Dietary Supplement|White chocolate|
15980406|NCT03033862|Device|Bioresorbable Vascular Scaffold|Bioresorbable Vascular Scaffold
15980325|NCT03034473|Other|Translational Research and multimodal treatment|"Blood/biopsy samples (tumor & mucosa) are taken pretherapeutically. Blood samples (serum & plasma) are drawn at 11 time points during RCTx (e.g. for analysis of 5-FU metabolism, genomic DNA extraction). After pathohistological workup of the TME specimen, the formalin-fixed material will be transferred to the central biobank of KFO179. Blood samples (plasma & serum) will be drawn during 5y-follow-up. Treatment (based on CAO/ARO/AIO-94- and CAO/ARO/AIO-04-phase-III trials of the GRCSG):
~Preoperative RCT: 28x1.8 Gy (total: 50.4 Gy, 5 fractions per week on d1-d38) combined with 5-FU (1000 mg/m2/d) as 120 h civ during 1st and 5th week.
~TME-surgery is performed 6 weeks after RCTx. 4 to 8 weeks after surgery, patients receive either 4 cycles 5-FU (500 mg 5-FU/m2 iv, d1-5, repeat d 29-33) or 3 cycles (6 single appl.) of FOLFOX regimen [(400 mg FA/m2, 2-h civ, d 1; 100 mg oxaliplatin/m2, 2-h civ in 500 ml Glucose 5%, d 1; 2400 mg 5-FU/m2 as 46-h civ) on d1+d15, d30+d45 and d60+d75]."
15980326|NCT03034460|Drug|CD5024 1% cream|500 µL on half-face, five days a week during 6 weeks
15980327|NCT03034460|Drug|CD5024 cream placebo|500 µL on half-face, five days a week during 6 weeks
15980328|NCT03034460|Drug|CD0271/CD1579 gel|500 µL on half-face, five days a week during 6 weeks
15980329|NCT03034460|Drug|CD0271/CD1579 gel placebo|500 µL on half-face, five days a week during 6 weeks
15980330|NCT03034447|Other|Questionnaire|Children and parents are going to inform data regarding socioeconomical status, asthma and rhinitis diagnosis, asthma and rhinitis control, medications, sleep complaints, and sleep habits
15980331|NCT03034447|Other|Lung Function Test|Children are going to blow in a machine that measures how the lung is working
15980332|NCT03034447|Other|Home Sleep Study|Children are going to sleep at home with a device that tells if they stop breathing during sleep
15980333|NCT03034434|Device|Trans-vaginal ultrasound|Three trans-vaginal ultrasounds, the 1st to be performed 8 hours post delivery, the 2nd 24 hours after delivery and the 3rd 48 hours after delivery.
15980334|NCT03034421|Behavioral|Bed rest|Patients will undergo bed rest for 48 hours following endoscopic valve implantation.
15980335|NCT03034408|Drug|Nalmefene|
15980336|NCT03034408|Drug|Baclofen|
15980337|NCT03034408|Drug|Placebo Oral Capsule|
15980338|NCT03034395|Procedure|Wide Local Excision|Surgery
15980339|NCT03034382|Drug|Morphine|5 mg morphine in 5 ml volume are injected perineurally as adjuvants for 10 ml of lidocaine + epinephrine 1:400,000 in ultrasound guided interscalene block
15980340|NCT03034382|Drug|Nalbuphine|5 mg nalbuphine in 5 ml volume are injected perineurally as adjuvants for 10 ml of lidocaine + epinephrine 1:400,000 in ultrasound guided interscalene block
15980341|NCT03034382|Drug|Bupivacaine 0.5%|10 ml of 1% lidocaine +1:400,000 epinephrine and 5 ml of bupivacaine 0.5% injected perineurally in interscalene block
15980342|NCT03034382|Drug|Lidocaine Hydrochloride 1% and epinephrine 1:400,000|10 ml of 1% lidocaine and 1:400,000 epinephrine were injected perineurally in interscalene block
15980343|NCT03034369|Other|Access to Care|Patient reported outcome survey administered at baseline and 12 months to measure satisfaction with access to care.
15980344|NCT03034369|Other|Depression Screening|Analysis of health care claims data for depression screenings at baseline and 12 months.
15980345|NCT03034369|Other|Patient-Provider Relationship|Patient reported outcome survey administered at baseline and 12 months to measure satisfaction with patient-provider relationship.
15980346|NCT03034369|Other|Patient-Clinic Interactions|Patient reported outcome survey administered at baseline and 12 months to measure satisfaction with patient-clinic interactions.
15980347|NCT03034369|Other|Stigma|Patient reported outcome survey administered at baseline and 12 months to measure perceived stigma.
15980348|NCT03034369|Other|Provider Continuity|Patient reported outcome survey administered at baseline and 12 months to measure satisfaction with provider continuity.
15980349|NCT03034369|Other|Symptom Severity|Patient reported outcome survey administered at baseline and 12 months to measure symptom severity.
15980350|NCT03034369|Other|Diagnoses|Patient reported outcome survey administered at baseline and 12 months to measure diagnoses.
15980351|NCT03034369|Other|Social support|Patient reported outcome survey administered at baseline and 12 months to assess social support and outlets.
15980352|NCT03034369|Other|Preventive Screening|Analysis of health care claims data for preventive screenings at baseline and 12 months.
15980353|NCT03034369|Other|Inpatient Hospitalization Utilization|Analysis of health care claims data for Inpatient Hospitalization Utilization at baseline and 12 months.
15980354|NCT03034369|Other|Inpatient Readmissions|Analysis of health care claims data for Inpatient Hospitalization Readmissions at baseline and 12 months.
15980355|NCT03034369|Other|Post-Admission follow-up|Analysis of health care claims data for Post-Admission follow-up at baseline and 12 months.
15980356|NCT03034356|Drug|Levetiracetam|Anticonvulsant drug
15980357|NCT03034356|Drug|Placebo|Placebo
15980358|NCT03034343|Behavioral|Mindfulness|
15980359|NCT03034330|Other|Two-Tier Stroke Family Empowerment|The family-based care management intervention will be implemented in two tiers. The first tier is the Family Care Management that a care manager is responsible for empowering family caregivers to support their stroke survivors through reorganizing family roles, enhancing family functioning, and maximizing their family and community resources. The second tier is led by trained volunteers who are responsible for increasing the capacity of caregivers for the mastery of stroke care by providing psychoeducation, skill-training, and social support. Each caregiver participant will be assigned a care manager and a volunteer. All care managers who are social workers from the participating centres have undergone 4-day training to improve their knowledge of stroke and skills required for the intervention. Similarly, volunteers have undergone 6.5-day training to equip them with the knowledge and skills to conduct the intervention.
15980360|NCT03034330|Other|Volunteer Support Psychoeducation|The active control group will receive a standard, non-family-based psychoeducation intervention provided by the trained volunteers under the supervision of care managers. It will provide 4 in-home visits and 2 telephone follow-up interviews about psychoeducation for caregivers of stroke survivors.
15980361|NCT03034317|Device|NeuRx DPS|Patients who are diagnosed with ALS, have initiated NIV and choose to have the NeuRx DPS implanted.
15980362|NCT03034304|Biological|MASCT-I|The final products of MASCT-I technology are dendritic cells (DC) and effector T cells
15980367|NCT03034278|Other|Not applicable - no intervention|Not applicable - no intervention, observational survey study.
15980371|NCT03034226|Other|Glucose clamp technique|Hyperinsulinemic euglycemic and hyperinsulinemic hypoglycemic clamp procedure with infusion of insulin and glucose
15980372|NCT03034213|Device|Gentrix™ Surgical Matrix (Treatment)|Gentrix™ Surgical Matrix will be placed in the retrorectus space. The anterior midline fascia will be closed with long-acting absorbable suture either with a running or interrupted manner as per the surgeon's discretion.
15980373|NCT03034213|Device|Permacol, Parietex, Progrip, Strattice Perforated, or Surgimend (Control)|A biological or prosthetic mesh (Permacol, Parietex, Progrip, Strattice Perforated, or Surgimend) will be placed in the retrorectus space. The anterior midline fascia will be closed with long-acting absorbable suture either with a running or interrupted manner as per the surgeon's discretion.
15980374|NCT03034200|Drug|ONC201|625mg ONC201 will be given on two consecutive days each week
15980375|NCT03034161|Device|Thermal imaging|Thermal imaging of the various stages of pressure ulcer will be analyzed to determine if a recognizable pattern of thermal distribution can be identified which can then be applied to identify patients at risk of developing pressure ulcers at an earlier stage in their hospital course.
15980376|NCT03034148|Diagnostic Test|Platelet Acetyl Coenzyme A Carboxylase analysis in CAD|
15980377|NCT03034135|Drug|Disulfiram/Copper|Disulfiram/copper gluconate is taken three times a day.
15980378|NCT03034135|Drug|Temozolomide (TMZ)|TMZ is given per standard of care
15980379|NCT03034109|Device|Transcranial Direct Current Stimulation|TDCS involves sending a weak electrical current to the brain to modulate brain functions.
15980380|NCT03034096|Drug|Propofol|Maintenance of general anesthesia with propofol infusion
15980381|NCT03034096|Drug|Volatile Agent|Maintenance of general anesthesia with volatile agent (sevoflurane, desflurane, or isoflurane)
15980382|NCT03034083|Behavioral|Elevate|Study participants receive needs assessment and 8 hours of classes over a 4-week period in healthy couple functioning behaviors, relationship quality/stability, and parenting skills.
15980383|NCT03034070|Diagnostic Test|Diagnostic performance 3D T1|"Although non-invasive, the prospective addition of a new MRI sequence to a routine MRI protocol is considered by our ethical committee as an interventional study."
15980384|NCT03034057|Drug|Sayana Press|Sayana Press in the Uniject injection system
15980387|NCT03034005|Drug|Budesonide|1600 ug inhaled daily for 6 weeks
15980388|NCT03033992|Device|Optune System (NovoTTF-200A System, Tumor Treating Fields, TTFields)|The Optune, a.k.a. Tumor Treating Fields (TTFields), will be worn for a minimum of 18 hours a day, with a recommendation of 22 hours/day for at least 23 days in a 28-day cycle. Cycle 1 includes 7 days training period, followed by 28 days treatment (total 35 days). The patients will receive multiple 28-day cycles of continuous Optune treatment. In the absence of treatment related serious adverse events or disease progression, Optune will continue up to 26 cycles.
15980389|NCT03033966|Device|NIRS based Cerebral Oximetry|Cerebral Oximetric measurement before and after decompressive craniectomy
15980390|NCT03033953|Dietary Supplement|Native whey|
15980391|NCT03033953|Dietary Supplement|Milk|
15980392|NCT03033953|Other|Strength training|
15980393|NCT03033940|Radiation|Observational use of fluoroscopy|
15980394|NCT03033927|Diagnostic Test|CTC isolocation and analysis|Circulating tumorigenic cell (CTC) isolation and enrichment will be performed using a proprietary invasion assay.
15980400|NCT03033901|Device|Polysomnography - Level 1 and Level 3|Participants will undergo simultaneous administration of Level 1 and 3 polysomnography on the rehabilitation unit with study funded sleep technologist present to meet Level 1 standards.
15980401|NCT03033901|Device|Actigraphy monitoring|Participants will undergo actigraphy monitoring to assess habitual sleep duration to determine readiness for polysomnography and examine trajectory and duration of sleep.
15980402|NCT03033901|Other|Sleep Apnea Screening|Participants and their family member or proxy, and clinical staff will be asked to answer questions in order to complete the three standardized sleep apnea screening measures.
15980403|NCT03033888|Behavioral|Health-Literacy Focused Education Session|
15980404|NCT03033875|Behavioral|Tele-Savvy|The Tele-Savvy program engages groups of six dementia family caregivers in a program that extends over 43 days. The program begins with a scheduled 75-minute group videoconference led by facilitators; similar group videoconferences then take place weekly for six weeks. In between the video-conferences, caregivers will receive daily emails with links to 5-15 minute on-line video lessons that can be watched on their own schedule as often as they wish. The videoconferences allow caregivers to report enactment of learned and self-developed management strategy behaviors into their own caregiving and allow them to raise questions. Each daily video presents a teaching point linked to the overall curriculum. The lesson is carried forward by brief, scripted talks by experts or is enacted in vignettes in which a fictional family caring for a father living with Alzheimer's demonstrates effective caregiving techniques linked to the day's teaching points.
15980405|NCT03033875|Behavioral|Healthy Living Education Program|The Healthy Living Education Program contains video and text materials on exercise, diet, and healthy living. Participants will be asked to log into the Canvas site daily over the course of six weeks to view the videos. Each participant will also receive 7 weekly brief scripted phone or video calls from a project facilitator to inquire about participants' use of the materials. Additionally, all participants will convene weekly for a video conference centered on the application of healthy living strategies. Facilitators will greet and check in with each of the caregivers, coach and debrief caregivers on the homework, answer questions and/or respond to feedback about the week's material, review key points and concepts from the week's video sessions and introduce new material, report on any activities that caregivers may have implemented based on the materials, and provide homework assignments.
15980408|NCT03033849|Device|Blood glucose monitoring system for self-testing Contour® Next One|"This is a user performance study, that is intended to show whether people with diabetes are able to obtain accurate measurement results with a blood glucose monitoring system (BGMS).
~The subjects' measurement technique (e.g. applying blood onto the system reagent, reading the result) will be observed and documented by study personnel.
~Immediately after the measurement by the subject, the study personnel will perform a measurement with the same test meter.
~Measurement results obtained by the subjects with the BGMS will be compared to measurement results obtained with the comparison method.
~Sample collection for the comparison measurement will be performed by study personnel within 5 min after the subject's measurement with the test meter.
~The samples will be collected from the subjects' skin puncture (if possible), an additional skin puncture (if required) will be documented.
~An additional skin puncture will be performed by study personnel with single-use lancing devices."
15980409|NCT03033849|Device|Blood glucose monitoring system for self-testing Accu-Chek® Aviva Connect|
15980410|NCT03033849|Device|Blood glucose monitoring system for self-testing FreeStyle Freedom Lite|
15980411|NCT03033849|Device|Blood glucose monitoring system for self-testing OneTouch® Verio|
15980412|NCT03033849|Device|Blood glucose monitoring system for self-testing GlucoMen® areo|
15980413|NCT03033836|Drug|ARV treatment|Dolutegravir 50 mg QD plus co-formulated emtricitabine 200 mg/tenofovir 300 mg QD.
15980414|NCT03033823|Drug|Magnesium|Usual care (i.e. without any restriction of drug therapy) plus oral tablet magnesium supplementation: 426.6mg of magnesium per day three times daily (i.e. 142.2 mg for each shot) throughout the study (i.e. fifteen days). In case of diarrhea, nearly half-dosage will be used (i.e. 189.6mg).
15980415|NCT03033823|Drug|Placebo Oral Tablet|Usual care (i.e. without any restriction of drug therapy) plus oral placebo, totally similar to the verum, three times daily throughout the study (i.e. fifteen days). In case of diarrhea, nearly half-dosage will be used.
15980416|NCT03033810|Device|Fractional flow reserve and instantaneous wave-free ratio|"To explain discrepancies between FFR and iFR using demographic, morphological, genetic and functional indices.
~The development of software for the automatic detection of the lowest point of microvascular resistance."
15980417|NCT03033797|Device|MoviLetrando|Half of the participants will play two different levels of the Game MoviLetrando, two minutes each.
15980418|NCT03033797|Device|MoveHero|Half of the participants will play 2 minutes of the game MoveHero.
15980419|NCT03033784|Drug|8 International Units (IU) of Oxytocin|Participants will receive one dose of intranasal oxytocin at a dose of 8IU.
15980420|NCT03033784|Drug|24IU of Oxytocin|Participants will receive one dose of intranasal oxytocin at a dose of 24IU.
15980421|NCT03033784|Drug|48IU of Oxytocin|Participants will receive one dose of intranasal oxytocin at a dose of 48IU.
15980422|NCT03033784|Drug|Placebo|Participants will receive an intranasal placebo to match the oxytocin doses.
15980423|NCT03033771|Device|Implantation with the Multilayer Flow Modulator (MFM)|Endovascular implantation with the MFM
15980424|NCT03033758|Other|Budesonide/Formoterol treated patients|patients who are eligible to start their treatment with budesonide/formoterol therapy
15980425|NCT03033745|Drug|IgPro20|A liquid formulation of normal human IgG at a concentration of 20% administered as a subcutaneous infusion at a dose prescribed by subject's physician prior to study entry.
15980426|NCT03033732|Drug|Methadone|Methadone is a synthetic analgesic drug used as a substitute drug in the treatment of opioid use disorder. Methadone is administered via strict daily witnessed ingestion.
15980427|NCT03033732|Drug|Buprenorphine-Naloxone|Buprenorphine/Naloxone is an opioid agonist treatment used to treat opioid use disorder. Buprenorphine/Naloxone is administered via flexible take home dosing once the patient has reached stabilization as per physician discretion.
15980428|NCT03033719|Procedure|Laparotomy|Open surgery
15980429|NCT03033719|Procedure|Laparoscopy|Minimally invasive surgery
15980430|NCT03033706|Procedure|Pulse pressure variation guided fluid therapy|Pulse pressure variation obtained from invasive blood pressure waveform
15980431|NCT03033706|Procedure|Traditional fluid therapy|4 ml/Kg/hr ringer solution plus rescue fluid bolus of 200 ml Ringer solution if Mean arterial pressure decreased by 20% with central venous pressure less than 4 mmHg.
15980432|NCT03033706|Procedure|Brain tumor excision|Brain tumor excision under general anesthesia
15980433|NCT03033693|Other|Bispectral index will be targeted at 50|The depth of general anesthesia will be monitored by bispectral index (BIS) at 50.
15980434|NCT03033693|Other|Bispectral index will be targeted at 35|The depth of general anesthesia will be monitored by bispectral index (BIS) at 35.
15980435|NCT03033680|Drug|[F-18]PBR06|PET radiopharmaceutical
15980436|NCT03033667|Dietary Supplement|G group|patients received 500 cc of glucose 10% containing 50 g of glucose proving patients with 200 Kcal with 556 mosmoles/L
15980437|NCT03033667|Dietary Supplement|group L|patients received 100 cc of lipid solution (soybean 30%, medium chain triglycerides 30%,olive oil 25%,fish oil 15% and 20 mg vitamine E) containing 20 g lipid which provided patients with 200 Kcal with osmolarity of 380 mosmoles /L. with a flow rate of infusion of 12.5 cc per hour
15980438|NCT03033667|Dietary Supplement|Group C|Over night fasting with no supplementation
15980439|NCT03033654|Other|Sunscreen, Actinica|Two Consecutive Sunscreen Applications
15980440|NCT03033641|Device|Ablation procedure|All enrolled subjects who have ablation targets identified will undergo CARTOFINDER guided ablation (CFGA) followed by PVI. Subjects will be followed per the protocol schedule. Subjects who have no ablation target identified on the baseline CARTOFINDER map will undergo ablation per the institution's standard of care and be followed for 7 days for safety monitoring, then exit from the study.
15980441|NCT03033628|Device|injection using DentalVibe comfort system|giving maxillary infiltration injection of dental local anesthesia using DentalVibe comfort system.
15980442|NCT03033628|Device|traditional dental injection|giving maxillary infiltration injection of dental local anesthesia without using DentalVibe comfort system.
15980443|NCT03033615|Device|PixelShine|Machine learning algorithm
15980444|NCT03033615|Device|Conventional processing|Iterative reconstruction software
15980445|NCT03033602|Behavioral|written exposure therapy|five sessions of writing about traumatic experience.
15980446|NCT03033602|Behavioral|CPT, cognitive only|12 sessions of cognitive therapy related to traumatic experience.
15980447|NCT03033589|Drug|Marcaine 0.25 % Injectable Solution|For the adductor canal block, 20 mL of 0.25% marcaine will be injected with the use of ultrasound guidance into the adductor canal by the attending anesthesiologist on the case in the pre-op holding area.
15980448|NCT03033589|Drug|Marcaine 0.25 % Injectable Solution|For the femoral nerve block, 30 mL of 0.25% marcaine will be injected with the use of ultrasound guidance around the femoral nerve sheath by the attending anesthesiologist on the case in the pre-op holding area.
15980449|NCT03033576|Biological|Ipilimumab|Given IV
15980450|NCT03033576|Biological|Nivolumab|Given IV
15980451|NCT03033563|Procedure|Intracytoplasmic sperm injection|Intracytoplasmic sperm injection
15980452|NCT03033550|Behavioral|brief negotiated mobile application|The intervention will supplement the standard of care with the following steps: (1) mobile- based brief negotiated Intervention ( BNI); (2) a customized companion communication vaccine report to be given before AFG sees provider; and (3) automated interactive Electronic Recall/Reminder Messages (Text messaging), including text messaging and access to a website which includes information about HPV, HPV Vaccine, and cervical cancer screening guideline.
15980453|NCT03033537|Drug|Verapamil|Local treatment of erectile dysfunction
15980454|NCT03033524|Drug|TTAC-0001|Calculated amount of drug will be diluted with normal saline and administered intravenously.
15980455|NCT03033511|Drug|Placebo for dexamethasone|Placebo for dexamethasone PO twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle.
15980456|NCT03033511|Drug|Placebo for rovalpituzumab tesirine|Placebo for rovalpituzumab tesirine administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
15980457|NCT03033511|Drug|Rovalpituzumab tesirine|Rovalpituzumab tesirine 0.3 mg/kg administered intravenously Day 1 of each 6-week cycle, omitting every third cycle
15980458|NCT03033511|Drug|Dexamethasone|Dexamethasone 8 mg administered orally (PO) twice daily on Day -1, Day 1 (the day of dosing), and Day 2 of each 6 week cycle, omitting every third cycle.
15980459|NCT03033498|Drug|ABBV-951|ABBV-951 administered by subcutaneous infusion.
15980460|NCT03033485|Radiation|18F-P3BZA|18F-P3BZA is a type of 18F labeled Picolinamide targeting melanin which is highly secreted in Melanoma. The toxicity of P3BZA was evaluated by SoBran Bioscience. The final report showed that there no signs of toxicity during the conduct of the toxicity study. No treatment-related differences were noted in mean body weight and body weight changes, clinical chemistry, haematology, or coagulation parameter after a single intravenous dose of P3BZA at 0.0589mg/kg.
15980461|NCT03033472|Drug|600 mg Clindamycin orally|600 mg Clindamycin orally 30 minutes before treatment
15980462|NCT03033472|Drug|Oral Placebo|Oral Placebo 30 minutes before treatment
15980463|NCT03033459|Behavioral|Motivational Interviewing|"Motivational Interviewing (MI) is a psychosocial intervention designed to help individuals increase readiness for behavior change by increasing intrinsic motivation and resolving ambivalence. MI founders MI conversations help clients change behavior through identifying and resolving discrepancies between goal behaviors and actual behaviors. Behavior change is promoted through the elicitation of change talk, or client-verbalized arguments for change. In MI, change talk is elicited through two major components: the therapeutic relationship, or the embodiment of the spirit of MI, and technical skill."
15980464|NCT03033459|Behavioral|Psychoeducation Control|Psychoeducation on infant development, age 0-15 months, brief education on breastfeeding.
15980465|NCT03033446|Radiation|Y-90 Radioembolization|Dose of Yttrium-90 is determined based on BSA, size of liver tumor, and dose modifications required for percent lung shunting between 10-20% on the Tc-99MMA scan
15980466|NCT03033446|Drug|Nivolumab|21 days after Radioembolization, 240mg of IV Nivolumab over 30 minutes will be administered every 2 weeks
15980467|NCT03033433|Drug|DCB-DM101|determination of optimal dose for Stage 2
15980468|NCT03033420|Device|A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules|A smartphone-based monitoring system including a) an integrated feedback loop between patients and clinicians and b) context-aware CBT modules
15980469|NCT03033407|Other|Tailored mobile coaching messages|Intervention was adding tailored mobile coaching to current usual diabetes care. The participants received regular mobile messages via Switch app according to entered data, such as self-monitoring of blood glucose, blood pressure, exercise, dietary record, medication record, and body weight. Contents of messages were alert for the unused, weather, behavioral recommendation, education about diabetes, and individualized advices.
15980470|NCT03033394|Drug|Beta-lactam antibiotic|Routine clinical dosing
15980471|NCT03033381|Device|Color Doppler Ultrasound|Radiological evaluation was performed by a single radiologist using CDUS for operated side testis of each patient preoperatively and on days 7 and 30 post-surgery. Longitudinal, anteroposterior, and transverse diameters of the testis were measured, and the testicular volume was calculated automatically using the CDUS device (volume = 0.523 × D1 × D2 × D3, where D1, D2, and D3 were the maximal longitudinal, anteroposterior, and transverse diameters defined by CDUS) for both testicles in each patient . Peak systolic velocity (PSV) was calculated using the CDUS system (in cm3/s) for both testicles in each patient.
15980472|NCT03033381|Device|Color Doppler Ultrasound|Radiological evaluation was performed by a single radiologist using CDUS for nonoperated side testis of each patient preoperatively and on days 7 and 30 post-surgery. Longitudinal, anteroposterior, and transverse diameters of the testis were measured, and the testicular volume was calculated automatically using the CDUS device (volume = 0.523 × D1 × D2 × D3, where D1, D2, and D3 were the maximal longitudinal, anteroposterior, and transverse diameters defined by CDUS) for both testicles in each patient . Peak systolic velocity (PSV) was calculated using the CDUS system (in cm3/s) for both testicles in each patient.
15980473|NCT03033368|Drug|Rilpivirine|Rilpivirine 25 mg tablet
15980474|NCT03033355|Drug|Intradetrusor injection of Botulinum Toxin-A|Using cystoscopy, Botulinum Toxin-A is injected into the bladder.
15980475|NCT03033342|Drug|Oral single doses of MRX-4|Oral single escalating doses of MRX-4
15980476|NCT03033342|Drug|Oral multiple doses of MRX-4|Multiple ascending doses of MRX-4 given twice daily for 10 days
15980477|NCT03033342|Drug|MRX-4 co-administered with omeprazole|MRX-4 given orally on Day 1 and Day 7, co-administered with omeprazole on Day 3 through Day 7
15980478|NCT03033342|Drug|Oral single doses of placebo|Single doses of placebo to match MRX-4
15981172|NCT03028142|Drug|6 mg RPL554 plus tiotropium|
15980479|NCT03033342|Drug|Oral multiple doses of placebo|Oral placebo given twice daily for 10 days to match the oral MRX-4
15980480|NCT03033342|Drug|Placebo co-administered with omeprazole|Placebo given orally on Day 1 and Day 7, co-administered with omeprazole on Day 3 through Day 7
15980481|NCT03033329|Drug|Single intravenous doses of MRX-4|Intravenous single escalating doses of MRX-4
15980482|NCT03033329|Drug|Single intravenous doses of placebo|Intravenous single doses of placebo to match MRX-4
15980483|NCT03033329|Drug|Multiple intravenous doses of MRX-4|Multiple ascending doses of MRX-4 given intravenously twice daily for 10 days
15980484|NCT03033329|Drug|Multiple intravenous doses of placebo|Multiple doses of placebo to match MRX-4 given intravenously twice daily for 10 days
15980485|NCT03033329|Drug|Single dose of intravenous and oral MRX-4|Crossover single dose of intravenous and oral MRX-4 given on Day 1 and Day 4
15980486|NCT03033316|Drug|Dexamethasone|
15980487|NCT03033303|Biological|Hu3F8|Day 1: hu3F8 infused iv over ~30 to 90 minutes. Day 3: hu3F8 infused iv over ~30 to 90 minutes. Day 5: hu3F8 infused iv over ~30 to 90 minutes.
15980488|NCT03033303|Drug|GM-CSF|Days -4 to 0: GM-CSF 250 mcg/m2/day, subcutaneously. Days 1 to 5: GM-CSF 500 mcg/m2/day, subcutaneously.
15980489|NCT03033303|Drug|Isotretinoin|Isotretinoin is administered at 160 mg/m2/d, divided into two doses, x14 days.
15980490|NCT03033290|Drug|Bu-Zhong-Yi-Qi-Tang|Qi-tonifying regimen of traditional Chinese herbal medicine
15980491|NCT03033290|Drug|placebo|placebo control
15980492|NCT03033277|Biological|Placebo transplantation|Intraovarian injection of placebo through vagina under the guidance of ultrasonic.
15980493|NCT03033277|Biological|HUC-MSCs transplantation|Intraovarian injection of HUC-MSCs through vagina under the guidance of ultrasonic.
15980494|NCT03033264|Drug|Dinoprostone|10 mg of a Dinoprostone vaginal insert.
15980495|NCT03033264|Device|Double lumen cervical ripening balloon.|Double lumen cervical ripening balloon.
15980496|NCT03033251|Device|Non Invasive Ventilation|Patients will receive non invasive ventilation as a standard of care.
15980497|NCT03033251|Device|High Flow Oxygen Cannula 50|Patients will receive High Flow Oxygen Cannula with a flow set at 50 L/min
15980498|NCT03033251|Device|High Flow Oxygen Cannula 30|Patients will receive High Flow Oxygen Cannula with a flow set at 30 L/min
15980499|NCT03033225|Procedure|Endoscopic Ultrasound|Undergo EUS-guided PDT
15980500|NCT03033225|Drug|Photodynamic Therapy|Undergo EUS-guided PDT
15980501|NCT03033225|Other|Quality-of-Life Assessment|Ancillary studies
15980502|NCT03033225|Other|Questionnaire Administration|Ancillary studies
15980503|NCT03033225|Drug|Verteporfin|Given IV
15980504|NCT03033212|Other|Therapist-Guided Rehabilitation|Rehabilitation consists of exercises guided by a certified physical therapist. These exercises include: aerobics, walking tests, stability exercises, and strengthening exercises.
15980505|NCT03033212|Other|Self-Guided Rehabilitation|Rehabilitation consists of self-guided exercises with provided instructions. These exercises include: aerobics, walking tests, stability exercises, and strengthening exercises.
15980506|NCT03033199|Drug|Probiotic Agent|probiotic capsules containing three viable and freezedried strains-Lactobacillus acidophilus,Lactobacillus casei, and Bifidobacterium bifidum：2 capsules, bid x 4 weeks for one cycle. It will be given for one or two cycles.
15980507|NCT03033199|Drug|Dexamethasone|Dexamethasone 40 mg per day, 4 consecutive days
15980508|NCT03033160|Drug|Estradiol Ring|
15980509|NCT03033147|Drug|Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet|2 gm of amoxicillin/ clavulanic acid combination orally 30 minutes before root canal treatment
15980510|NCT03033147|Drug|Oral placebo|placebo 30 minutes before root canal treatment
15980511|NCT03033134|Device|BSJ003W|BSJ003W implant
15980512|NCT03033121|Drug|Growth Hormone|
15980513|NCT03033108|Drug|Emixustat|Once daily, tablet for oral administration
15980514|NCT03033095|Drug|Etanercept ® 50 mg|The etanercept is not the experimental study drug. Etanercept is a treatment justifying the inclusion of patients and is used in accordance with its marketing authorization.
15980515|NCT03033082|Other|Questionnaire sheets|"A- Marital satisfaction Index (MSI). Interview (Modified Arabic translation)
~B- Sexual Satisfaction Scale:(SSS). The Arabic version of the sexual satisfaction scale was used.
~C- International Index of Erectile Function Questionnaire (IIEF-5): For male subjects.
~D- The Eysenck Personality Questionnaire (EPQ):
~The Arabic version of the EPQ was used."
15980516|NCT03033069|Drug|Brexpiprazole (OPC-34712)|
15980517|NCT03033069|Drug|Sertraline|
15980518|NCT03033069|Other|Placebo|
15980519|NCT03033056|Behavioral|Test of fear conditioning|Behavioral and brain correlates of conditioned fear generalization and avoidance will be assessed using fMRI and related to levels of anxiety related psychopathology.
15980520|NCT03033043|Device|Relay Pro Stent-Graft|Endovascular treatment of an aortic dissection
15980521|NCT03033030|Diagnostic Test|Ultrasound|Ultrasound examination
15980522|NCT03033017|Other|Blood Testing|
15980523|NCT03033004|Device|Conventional Cryolipolysis|Treatment will be a cold exposure of the subcutaneous fat for 60 minutes using the Polarys device. Polarys is a commercially available cryolipolitic device.
15980524|NCT03033004|Device|Contrast Cryolipolysis|Treatment will consist of a heat exposure of the subcutaneous fat for 10 minutes followed by 60 minutes of cold exposure and 10 minutes of heat exposure again. Cold and heat will be provided by the Polarys device. Polarys is a commercially available cryolipolitic device.
15980525|NCT03033004|Device|Reperfusion Cryolipolysis|Treatment will be a cold exposure of the subcutaneous fat for 60 minutes followed by 10 minutes of heat exposure using the Polarys device. Polarys is a commercially available cryolipolitic device.
15980526|NCT03032978|Other|Calcium hydroxide|Pulp capping material
15980527|NCT03032978|Other|Calcium silicate|Pulp capping material
15980528|NCT03032965|Drug|Adenosine|"Subject will receive 6-24 mg of intravenous adenosine given rapidly for each PV in order to assess dormant PV conduction.
~Subjects in this group will also receive isoproterenol to assess inducibility of AF with re-isolation of PVs and targeting non PV sources of AF if necessary.Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate."
15981173|NCT03028142|Drug|Placebo plus tiotropium|
15980529|NCT03032965|Drug|Isoproterenol|Isoproterenol will be infused through a femoral vein at rates of 5, 10, 15, and 20 μg/min for 2 minutes at each infusion rate. The isoproterenol infusion will be discontinued upon induction of AF, a decrease in systolic blood pressure to<85 mmHg, complaints of severe chest tightness, electrocardiographic changes suggestive of ischemia, or upon completion of the infusion protocol.
15980530|NCT03032952|Other|"Feel Stress Free mobile application"|This online and mobile application uses relaxation techniques, thought challenging, mini-games and mood tracking to help reduce feelings of stress, anxiety and depression.
15980531|NCT03032939|Procedure|endotracheal intubation|standard endotracheal intubation of surgical patients after induction of anesthesia
15980532|NCT03032926|Behavioral|Open Trial|Behavioral Intervention
15980533|NCT03032913|Procedure|Blood samples|Blood samples for both group
15980534|NCT03032913|Procedure|Portal vein blood sample|Portal vein blood sample during surgery procedure for the Pancreatic Ductal Adenocarcinoma group
15980535|NCT03032887|Behavioral|voice prompts|voice prompts on disinfectant dispenser
15980536|NCT03032887|Behavioral|agitation|Education, reminders and optimising materials
15980537|NCT03032874|Procedure|Colonoscopy|They all had screening colonoscopy
15980538|NCT03032861|Other|Orange juice|Thirty days before the beginning of trial, women (n= 10; BMI 23.8 kg/m2; 28 years) will be advised to not consumed foods containing prebiotic, probiotic and fibers, and citrus fruits and beverages. After 30 days, the participants will consume 300 mL of orange juice daily during 60 days. After 60 days of orange juice intervention, the participants will be submitted to 30 days of washout. Samples of blood, urine and feces will collect in five different occasions (baseline, 30 day, 60 day, 90 day, and 120 day) in order to evaluate the prebiotic effect of orange juice on gut microbiota and the bioavailability of its flavanones in blood, urine and feces.
15980539|NCT03032848|Drug|Conjugated Estrogen|use of 1 gram per day
15980540|NCT03032848|Drug|Promestriene|use of 1 gram per day
15980541|NCT03032848|Drug|Estriol|use of 1 gram per day
15980542|NCT03032848|Drug|Vaginal Moisturizer - Cream|use of 1 gram per day
15980543|NCT03032809|Other|Vessel Wall MR imaging|Magnetic resonance images of the intracranial arteries will be acquired using the 3 Tesla MR scanners. Intracranial vessels will be imaged by high resolution vessel wall MR imaging to characterize vessel wall enhancement characteristics and wall thickness.
15980544|NCT03032796|Behavioral|Body-Brain Trainer|A novel video game-based intervention that incorporates i) adaptive algorithms critical for cognitive training, ii) physiological measures such as heart rate into the core game mechanics, and iii) motion capture technology to incorporate whole-body kinematics into game play. This group will train for 36 minutes per day, 3 days a week for 8 weeks.
15980545|NCT03032796|Behavioral|Body Trainer|"A novel video game-based intervention that incorporates physiological measures such as heart rate into the core game mechanics, with motion capture technology to incorporate whole-body kinematics into game play. This group will train for 36 minutes per day, 3 days a week for 8 weeks. The Body Trainer group will train using closed-loop adaptive algorithms to challenge physical performance as guided by heart rate, such that the amount of movement needed to respond on each task will dynamically change depending upon the participant being below/above a predetermined derived level of exertion. During Body Training, participants will only perform a basic reaction task in each level/module to ensure only the most minimal cognitive challenge is present"
15980546|NCT03032796|Behavioral|Brain Trainer|"The Brain Trainer group will train using the aforementioned closed-loop adaptive algorithms to challenge cognitive performance, except while sitting down and playing with an Xbox control pad (thus removing all physical training aspects). This group will train for 36 minutes per day, 3 days a week for 8 weeks."
15980547|NCT03032796|Behavioral|Expectancy Matched Control|The placebo-matched control group will engage in a battery of three apps (playing each app 10 minutes per day, 5 days a week for 8 weeks completed in the laboratory that we believe will have no significant impact on the cognitive or physical fitness measures we are assessing: i) an app with 100 different logic games of varying difficulty and length, ii) a language-learning app with 10 language options, and iii) an app that offers a guided Tai Chi program. We have pre-determined that this approach generates matched expectancy compared to our training groups: we asked 100 naïve individuals to predict how they would expect to improve performance on our outcome measures after training on one of these platforms, revealing that placebo training generates equivalent expectations of improvement across each outcome measure as the BBT group.
15980548|NCT03032783|Radiation|Total-Body Irradiation|Undergo Total Body Irradiation
15980549|NCT03032783|Procedure|Donor Lymphocyte Infusion|Undergo Donor Lymphocyte Infusion
15980550|NCT03032783|Drug|Cyclophosphamide|Given IV
15980551|NCT03032783|Drug|Tacrolimus|Given IV
15980552|NCT03032783|Drug|Mycophenolate Mofetil|Given IV
15980553|NCT03032783|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo Hematopoietic Stem Cell Transplantation
15980554|NCT03032770|Device|two-dimensional ultrasound and color Doppler|the eligible participants will be searched for signs suggestive of placenta accreta; low implantation of the gestational sac (<4cm from the external os), presence of placental lakes, Disruption of placental-myometrial interface and trophoblast overlapping a uterine scar by 2 dimensional transvaginal ultrasound and Intraplacental dilated vessels, turbulent blood flows and greatly increased periplacental vascularity by Doppler ultrasound by level II sonographer and co-investigator under his supervision using ultrasound device.
15980555|NCT03032757|Dietary Supplement|Essential amino acids|240 mg essential amino acids per kg body weight dissolved in 500 ml of water provided after exercise.
15980556|NCT03032744|Other|Asthma Assessment & Management|Asthma Assessment & Management based on NAEPP-EPR3 guidelines
15980557|NCT03032744|Other|Asthma Education|Asthma education on medications
15980558|NCT03032744|Other|Controller medication at school|Students will receive the morning dose of their daily preventive asthma medication at school on school days.
15980559|NCT03032731|Behavioral|Website and pedometer intervention|Self-directed, website-based intervention delivered with a pedometer to promote understanding of health and health behaviour change.
15980560|NCT03032731|Other|Control|Standard, publicly available NHS resources for healthy lifestyles.
15980561|NCT03032718|Behavioral|Whole-body vibration training|Whole-body vibration exercise
15980677|NCT03031847|Device|Cardiac Resynchronization Therapy Pacemaker|Patients randomized to the pacemaker arm will receive a CRT-P device.
15980562|NCT03032705|Device|SonicFill™ 2|The intervention in arm 1 is SonicFill™ 2, a sonic-activated, bulk fill dental composite system for posterior restorations that requires no additional capping layer.
15980563|NCT03032705|Device|Filtek™ Supreme|The intervention in arm 2 is Filtek™ Supreme Ultra, a Universal Nanocomposite dental restorative material that is visible-light activated and designed for use in anterior and posterior restorations of any class.
15980564|NCT03032692|Device|SWORD|Both arms will perform two separate sessions consisting of one exercise - shoulder flexion with elbow flexion at 90 degrees - for 4 minutes in two experimental conditions: with and without biofeedback. Group 1 will perform the exercise with biofeedback first and without biofeedback after; group 2 performed the exercise in the opposite order. The SWORD system will be used to record movement data in both sessions.
15980565|NCT03032692|Other|Exercise with biofeedback|
15980566|NCT03032692|Other|exercise without biofeedback|
15980567|NCT03032679|Other|Non interventional study|No intervention
15980568|NCT03032666|Drug|sofosbuvir/velpatasvir|treatment of hepatitis C genotype 1-6 in patients with transfusion-dependent thalassemia.
15980569|NCT03032653|Other|Late Rehabilitation|"Post-0p: Non weight-bearing and no range of motion for 2 weeks post treatment. 2 weeks: Splint removed, removable pre-fabricated walking boot applied. WB as tolerated with boot, range of motion out of boot.
~6 weeks: Boot discontinued and full unrestricted and unprotected WB and ROM permitted 6 weeks:"
15980570|NCT03032653|Other|Early Rehabilitation|Weightbearing and range of motion as tolerated within the limitations of participant's own comfort. Use of ambulatory aides of any kind is permitted as needed without restriction. No brace or splint of any kind is permitted
15980571|NCT03032640|Other|Oral Glucose Tolerance Test (OGTT)|Once we test the fasting plasma glucose (after an overnight fast), subject will receive a 75g glucose beverage they will have to drink within 5 minutes. Then after drinking the beverage, 8 blood samples will be collected through the IV catheter, over the next 3 hours.
15980572|NCT03032640|Other|Assessment of dietary compliance|Assessment of consumption of non-caloric artificial sweeteners
15980573|NCT03032640|Other|Stool sampling|Subjects will provide a stool sample.
15980574|NCT03032640|Other|Sodium Saccharin|Subjects in group 1 and group 3 will be provided with sodium saccharin.
15980575|NCT03032640|Other|Placebo|Subjects in group 2 will be provided with placebo.
15980576|NCT03032640|Other|Lactisole|Subjects in group 3 and group 4 will be provided with lactisole.
15980577|NCT03032627|Procedure|Collection of discarded heart tissue|Discarded heart tissue will be collected from patients undergoing the aforementioned cardiac surgeries.
15980578|NCT03032614|Drug|Carboplatin|Carboplatin is a second generation tetravalent organic platinum compound. Similar to cisplatin, carboplatin produces predominantly interstrand DNA crosslinks as opposed to DNA-protein crosslinks. Carboplatin is cell-cycle non-specific.
15980579|NCT03032614|Drug|Eribulin|Eribulin Mesylate is a synthetic halichondrin analog.
15980580|NCT03032614|Drug|Veliparib|Veliparib is a potent PARP inhibitor that delays the repair of DNA damage induced by chemotherapeutics.
15980581|NCT03032601|Dietary Supplement|N-acetyl Cysteine|The study consists of two arms. The first arm of this study will receive intravenous and oral NAC, a strong antioxidant that increases brain glutathione, which may be beneficial in MS. NAC, is the N-acetyl derivative of the naturally occurring amino acid, L-cysteine. It is a common over-the-counter supplement that is also available as an injectable pharmaceutical that protects the liver in cases of acetaminophen overdose. It has the potential to reduce markers of oxidative damage, protect against cell death, and to increase glutathione in blood, which might be useful in preventing oxidative damage in MS patients. The second arm will be a waitlist control receiving standard MS care. It should be noted that both arms will receive standard of care while enrolled into the study.
15980582|NCT03032588|Biological|sIPV|Participants will receive single dose (0.5 milliliter [mL]) of sIPV as a suspension for intramuscular injection on Day 1.
15980583|NCT03032588|Biological|cIPV|Participants will receive single dose (0.5 mL) of cIPV as a suspension for intramuscular injection on Day 1.
15980584|NCT03032575|Behavioral|SEARCH010/RV254|
15980585|NCT03032562|Diagnostic Test|Multimodal measurement of respiratory muscle function and strength|Sleep-studies, capnography, spiromanometry, phrenic nerve conduction studies, magnetic phrenic nerve stimulation, diaphragmatic ultrasound
15980586|NCT03032549|Dietary Supplement|RTD|Ready to Drink Supplement
15980587|NCT03032549|Dietary Supplement|Placebo|Placebo
15980588|NCT03032536|Drug|AL-3778|AL-3778 tablets or capsules
15980589|NCT03032536|Drug|Entecavir|Entecavir once daily for 14 days
15980590|NCT03032536|Drug|Tenofovir disoproxil fumarate|Tenofovir disoproxil fumarate once daily for 14 days
15980591|NCT03032523|Diagnostic Test|Standard of care glucose test|If the CGM in the remote monitoring group detects a blood sugar less than 46mg/dl, a confirmatory standard of care glucose test will be performed to confirm the low blood sugar.
15980592|NCT03032510|Drug|Eravacycline|
15980593|NCT03032510|Drug|Ertapenem|
15980594|NCT03032510|Drug|Placebo|
15980595|NCT03032510|Drug|Levofloxacin|
15980596|NCT03032497|Device|EEG-based BCI analysis of fear avoidance|Scalp EEG signals that are acquired and recorded from experiment 1 and 2 are analysed for healthy controls, participants with low back pain and participants with lower limb pain. Comparisons of signal patterns are made between groups. Assuming unique signal patterns are obtained for each groups, these signals are further analysed and used to develop a feedback brain training system to better manage pain and ideally reduce fear-avoidant behaviors towards pain.
15980597|NCT03032484|Drug|Bevacizumab|Bevacizumab is FDA approved as a treatment for recurrent Glioblastoma following failure of radiation therapy and temozolomide.
15980598|NCT03032484|Drug|TVB-2640|TVB-2640 is a potent and reversible inhibitor of the FASN enzyme. TVB-2640 inhibits the β-ketoacyl reductase (KR) enzymatic activity of the FASN enzyme.
15980599|NCT03032471|Other|There is no intervention for this study. Patients are allocated to the study groups based on whether or not DCI occurs.|There is no intervention for this study. Patients are allocated to the study groups based on whether or not DCI occurs.
15980600|NCT03032458|Drug|Pethidine|pethidine 25 mg IV bolus injection before start of session plus placebo gel then then IV infusion, so that the total dose doesn't exceed 1mg/kg
15981206|NCT03027908|Other|Fluoride Toothpaste 1|Toothpaste containing 1450 ppm F as Sodium Fluoride
15980601|NCT03032458|Drug|Ketorolac|ketorolac IV bolus injection before start of session plus placebo gel then 30 mg IV infusion so that total dose doesn't exceed 60 mg.
15980602|NCT03032458|Drug|Xylocaine Gel|Xylocaine gel locally 15 minutes before session with 10 mg normal saline IV bolus before session then IV normal saline infusion then
15980603|NCT03032445|Other|Alcoholic Beer|Subject will be asked to consume alcoholic beer within 30 minutes. Subject will be monitored for 60 minutes at commencement of study beverage.
15980604|NCT03032445|Other|Non alcoholic beer|Subject will be asked to consume non alcoholic beer within 30 minutes. Subject will be monitored for 60 minutes at commencement of study beverage.
15980605|NCT03032432|Device|Dynamic Elastic Garment (DEG) brace|Improve function of the shoulder
15980606|NCT03032432|Drug|Corticosteroid injection|Injection to improve rotator cuff tendinosis pain and functional score
15980607|NCT03032419|Biological|IPV-Al SSI|3 primary injections of IPV-Al SSI at 6, 10, and 14 weeks of age and 1 booster at 9 months of age
15980608|NCT03032419|Biological|IPV SSI|3 primary injections of IPV SSI at 6, 10, and 14 weeks of age and 1 booster at 9 months of age
15980609|NCT03032406|Drug|Hydroxychloroquine|Hydroxychloroquine
15980610|NCT03032406|Drug|Everolimus|Everolimus
15980611|NCT03032393|Other|high-power|Subjects will stand with hands on their hips, elbows pointing out and feet approximately one foot apart (high-power) for 20 seconds.
15980612|NCT03032393|Other|low-power|Subjects will stand with hands and arms wrapping around the torso and feet together (low-power) for 20 seconds.
15980613|NCT03032380|Drug|Cefiderocol|2000 mg intravenously every 8 hours for a period of 7 to14 days (dosage adjustment is necessary based on renal function)
15980614|NCT03032380|Drug|Meropenem|2000 mg intravenously every 8 hours for a period of 7 to 14 days (dosage adjustment is necessary based on renal function)
15980615|NCT03032380|Drug|Linezolid|600 mg of linezolid administered intravenously over 30 minutes to 2 hours, every 12 hours.
15980616|NCT03032367|Drug|bedaquiline|
15980617|NCT03032354|Drug|Lactobacillus rhamnosus GG and Bifidobacterium lactis BB12|Combination therapy of probiotics during 6 months
15980618|NCT03032354|Other|Placebo, (Placebo group)|Placebo during 6 months
15980619|NCT03032328|Dietary Supplement|vitamin D supplement|Patients will be given a dose of vitamin D for at least 2 months
15980620|NCT03032315|Drug|TAH Tablet (Telmisartan80/Amlodipine besylate10/Hydrochlorothiazide12.5)|Telmisartan 80.0 mg, Amlodipine besylate 13.87 mg (Amlodipine 10 mg), Hydrochlorothiazide 12.5 mg combination-drug would be administered orally once
15980621|NCT03032315|Drug|TWYNSTA(Telmisartan+Amlodipine besylate)|TWYNSTA 2 Tab. 40/5mg(Telmisartan 40 mg, Amlodipine besylate 6.935 mg(Amlodipine 5 mg) would be administered orally once
15980622|NCT03032315|Drug|Hydrochlorothiazide|Dichlozid 1 Tab.(Hydrochlorothiazide 12.5 mg) would be administered orally once
15980623|NCT03032302|Dietary Supplement|Swisse Womens 50+ Ultivite Multivitamin|Single tablet taken once daily
15980624|NCT03032302|Dietary Supplement|Holland and Barrett Triple Strength Omega-3 Fish Oil|Single capsule taken once daily
15980625|NCT03032289|Behavioral|Active Transport|Active transport, most commonly walking or cycling, is the use of physical activity to commute.
15980626|NCT03032276|Other|Safe motherhood and newborn health promotion package|The intervention package consists of three components: facility, community and linkages between the community and health facilities. Facility based interventions will serve both the comparison and intervention arms. However, other two interventions will serve the intervention arm only. Specific interventions and approaches for the three components will be implemented within the MOH&FW service delivery system to improve MNH practices in families and communities and to increase the use of MNH services from appropriate facilities/providers. The intervention package has been developed based on the experiences from SMPP in Narsingdi district and on the basis of consultations with the International Advisory Body (IAB) that included GoB, JICA, ICDDR,B, other experts and stakeholders.
15980627|NCT03032263|Device|Video Laryngoscopy for nasal intubation|The anesthesia provider will use a video laryngoscope to facilitate the nasal intubation for the procedure.
15980628|NCT03032263|Device|Direct Laryngoscopy|These patients will be nasally intubated for their procedure via direct laryngoscopy
15980629|NCT03032250|Other|Communication Intervention|Attend interventionist sessions
15980630|NCT03032250|Other|Watch video|Watch video on a DVD
15980631|NCT03032250|Other|Module completion of the Prepare to Care kit|Complete modules of the Prepare to Care kit
15980632|NCT03032250|Other|Quality-of-Life Assessment|Ancillary studies
15980633|NCT03032250|Other|Survey Administration|Ancillary studies
15980634|NCT03032250|Other|Salivary cortisol collection|Obtained at three times a day (at awakening, 30 minutes post awakening and bedtime) for two consecutive days for eligible caregivers in both groups. Samples collected by placing a cotton ball under the tongue for approximately 1-2 minutes which is subsequently stored in a plastic tube and refrigerated.
15980635|NCT03032237|Other|Nutritional intervention - protein-rich|"Both groups will receive readymade meals (Sligro) for each day during the 4-week intervention period (28 hot meals in total per participant). They will also receive other food products from FrieslandCampina's assortment to freely consume during the intervention period.
~To keep the intervention as close as possible to the real life situation, meals and foods will be home-delivered twice a week as the participants are already used to.
~Intervention group will receive protein-rich meals and protein-rich foods and drinks."
15980636|NCT03032237|Other|Nutritional intervention - standard|"Both groups will receive readymade meals (Sligro) for each day during the 4-week intervention period (28 hot meals in total per participant). They will also receive other food products from FrieslandCampina's assortment to freely consume during the intervention period.
~To keep the intervention as close as possible to the real life situation, meals and foods will be home-delivered twice a week as the participants are already used to.
~Control group will receive standard (not protein-rich) meals and standard foods and drinks."
15980637|NCT03032224|Procedure|Resection of the esophagus and the gastroesophageal junction|
15980638|NCT03032211|Device|Alfapump|Implant Alfapump® System
15980639|NCT03032198|Device|Imagio OA/US|Diagnostic opto-acoustic gray-scale ultrasound
15980640|NCT03032185|Device|Transcutaneous Elevtrical Nerve Stimulation|
15980643|NCT03032146|Procedure|Cardiac Rehabilitation|Cardiac rehabilitation is a multidisciplinary framework which focuses on improving the functioning of heart disease patients to facilitate and optimize the return to a regular routine as early as possible. The rehabilitation program provides the tools for the maintenance of a healthy lifestyle, encouraging participants to take part in recreational activities and includes extending their daily functioning.
15980644|NCT03032133|Procedure|Regional pain control|Regional pain catheter
15980645|NCT03032133|Procedure|Local pain control|Local intraarticular pain catheter
15980646|NCT03032120|Dietary Supplement|Orange juice|Lean and obese subjects drank one single dose (5 mL/kg body weight) of fresh-squeezed orange juice (FOJ) and processed orange juice (POJ) followed by an ad libitum breakfast. A washout period of seven days among each beverage (FOJ, POJ and control) was applied.
15980647|NCT03032120|Dietary Supplement|Control|Lean and obese subjects drank one single dose (5 mL/kg body weight) of an energy and sugars-matched orange-flavored drink (control), followed by an ad libitum breakfast. A washout period of seven days among each beverage (FOJ, POJ and control) was applied.
15980648|NCT03032107|Drug|T-DM1|-T-DM1 will be administered intravenousely in clinic on day 1 of each 3-week cycle
15980649|NCT03032107|Drug|Pembrolizumab|-Pembrolizumab will be administered intravenousely in clinic on day 1 of each 3-week cycle
15980650|NCT03032094|Procedure|connective tissue graft|palatal connective tissue graft to attain root coverage
15980651|NCT03032081|Other|High intensity exercise|High intensity exercise, defined as an exercise intensity of > 80% of heart rate reserve. Heart rate reserve is the maximum measured heart rate minus the measured resting heart rate.
15980652|NCT03032081|Other|Moderate intensity exercise|Moderate intensity exercise, defined as 50 to 60% of heart rate reserve for 40 to 47 minutes per day, 4 days per week, for 8 weeks. Heart rate reserve is the maximum measured heart rate minus the measured resting heart rate.
15980653|NCT03032068|Other|At-Home Monitoring|Patient reported outcomes, functional measures such as the maximum attainable range of motion (AROM) and the number of steps taken will be tracked using sensors worn by the patient. The AROM sensor values will be verified with range of motion measurements taken using a goniometer during therapy and MD visits.
15980654|NCT03032042|Drug|Azithromycin|
15980655|NCT03032042|Drug|Albendazole|
15980656|NCT03032042|Drug|Delayed treatment|Albendazole+Azithromycin
15980657|NCT03032029|Device|Adaptive Servo-Ventilation|Adaptive Bi-Level positive airway pressure with a targeted minute ventilation and auto-adjusting expiratory pressure level.
15980658|NCT03032003|Other|Cysticlean|2 BID for 15 days
15980659|NCT03032003|Other|Placebo|2 BID for 15 days
15980660|NCT03031990|Behavioral|In-person yoga for fertility group|The participants in this group will complete the Yoga for Fertility class at Pulling Down the Moon: An Integrative Center for Fertility. This consists of a 30 minute discussion session followed by a 60 minute Vinyasa style yoga class one time a week for a total of 6 weeks. Participants must attend at least 5 out of the 6 sessions to be included in the analysis.
15980661|NCT03031990|Behavioral|Online yoga for fertility group|The participants in this group will complete an online webinar of the Yoga for Fertility class and engage in a home yoga practice with the Pulling Down the Moon Yoga DVD. This will occur one time a week for a total of 6 weeks. Participants must complete at least 5 out of the 6 sessions to be included in the analysis.
15980662|NCT03031990|Behavioral|In person discussion only group|The participants in this group will attend an in-person 30 minute discussion session at Pulling Down the Moon. This will occur one time a week for a total of 6 weeks. Participants must complete at least 5 out of the 6 sessions to be included in the analysis.
15980663|NCT03031977|Other|visceral mobilization|
15980664|NCT03031964|Device|revision multihole acetabular cup|post market study of multi hole revision acetabular cup
15980665|NCT03031951|Behavioral|Lifestyle Intervention Group|The intervention group will start the lifestyle intervention with a 60-minute nutrition appointment given by a certified dietitian. This meeting is intended to provide a well-balanced personalized diet plan, calculated to create a moderate reduction from ~300 to 500kcal/day according to each participant's energy requirements and preferences. Two additional follow-up appointments are also planned to adjust the individual energy requirements throughout the intervention. Subjects will attend 12 educational sessions for a healthy lifestyle in groups of 10-15 participants, for approximately 4 months. Sessions will last 60-90 minutes and will include educational content and practical application classroom exercises in the areas of physical activity and exercise, diet and eating behavior, and behavior modification. The inclusion of self-regulation skills, such as pedometer use, recording food regularly and monitoring weight, is also part of the curriculum. Weight will be monitored weekly.
15980666|NCT03031938|Drug|Investigational medical product (IMP) administered in parent study|IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen, diclofenac, administered in parent study
15980667|NCT03031925|Other|ANXA2|serum and urinary concentration
15980668|NCT03031912|Biological|V920 (rVSVΔG-ZEBOV-GP) Ebola Virus Vaccine|The rVSVΔG-ZEBOV-GP vaccine is a live attenuated recombinant virus consisting of a single recombinant VSV isolate (11481 nt, strain Indiana) with the gene for the Zaire ebolavirus GP (ZEBOV GP), Kikwit strain replacing the gene for the VSV GP, which has been deleted. This results in a VSV backbone with the ZEBOV GP constituting the envelope of the virus.
15980669|NCT03031912|Other|Saline|Normal saline (0.9%) has been chosen as an inert substance to serve as placebo control.
15980670|NCT03031899|Procedure|Biopsy|rose bengal stain and toluidine is applied over a premalignant lesion and positively stained lesions are subjected to biopsy.
15980671|NCT03031899|Diagnostic Test|Rose Bengal|the lesions stained positive were subjected to biopsy
15980672|NCT03031899|Diagnostic Test|toluidine blue|the lesions stained positive were subjected to biopsy
15980673|NCT03031886|Other|low glycaemic index intervention|Low GI sweetener would be added to the treatment meals. 30 grams of isomaltulose to dinner and breakfast and 20 grams of isomaltulose to lunch and snack.
15980674|NCT03031886|Other|high glycaemic index intervention|High GI sweetener would be added to the treatment meals. 30 grams of sucrose to dinner and breakfast and 20 grams of sucrose to lunch and snack.
15980675|NCT03031873|Device|MRI perfusion imaging|Evaluate the evolution of progressive obliteration of the AVM nidus
15980676|NCT03031860|Other|Semiquantitative Cough Strength Score|Evaluate extubation outcome according to degree of evaluated Semiquantitative Cough Strength Score
15980678|NCT03031847|Device|Cardiac Resynchronization Therapy Defibrillator|Patients randomized to the defibrillator arm will receive a CRT-D device.
15980679|NCT03031834|Drug|Quinapril|
15980680|NCT03031821|Drug|Metformin|Metformin Duration: 18 months 850 mg PO OD x 30 days then 850 mg PO BID for duration
15980681|NCT03031821|Drug|Placebo Oral Tablet|"Placebo Oral Tablet Duration 18 months
~1 tablet (850 mg) PO OD x 30 days then 1 tablet PO BID for duration"
15980682|NCT03031808|Drug|Lidocaine spray (2%)|Spraying trachea from 2 cm above the vocal cords and 5 cm down with a straw with multiple side holes
15980683|NCT03031808|Drug|Muscle Relaxant (Rocuronium)|After induction of anesthesia, the participants are given 0,6 mg/kg bodyweight intravenously.
15980684|NCT03031808|Other|No Muscle relaxant, no Lidocaine|This group get general anesthesia without Rocuronium or Lidocaine
15980685|NCT03031795|Drug|Ketorolac|Oral Tablet
15980686|NCT03031795|Drug|Placebo|Oral Tablet
15980687|NCT03031782|Drug|AIN457|Secukinumab (AIN457) is a high-affinity fully human monoclonal anti-human antibody that targets IL-17A and neutralizes activity.
15980688|NCT03031782|Other|Matched placebo|Matched placebo to AIN457 for use in the double blind Treatment Period 2
15980689|NCT03031756|Device|glycine powder air-polishing (Air-Flows)Perio Powder|
15980690|NCT03031756|Device|ultrasonic (Piezon Master 700; EMS, Nyon, Switzerland)|
15980691|NCT03031730|Drug|Carfilzomib|Given IV
15980692|NCT03031730|Drug|Dexamethasone|Given PO
15980693|NCT03031730|Drug|Dexamethasone Sodium Phosphate|Given IV
15980694|NCT03031730|Drug|Lenalidomide|Given PO
15980695|NCT03031730|Drug|MDM2 Inhibitor KRT-232|Given PO
15980696|NCT03031717|Procedure|Transjugular intrahepatic portosystemic shunt|
15980697|NCT03031704|Procedure|Endoscopic mucosectomy|Performing adenoma resection through standardized endoscopic mucosectomy of duodenal adenoma.
15980698|NCT03031691|Drug|brontictuzumab|starting dose of 1.5mg/kg administered intravenously (IV)
15980699|NCT03031691|Drug|trifluridine/tipiracil|
15980700|NCT03031678|Device|Electric-Acoustic Stimulation (EAS) Cochlear Implant System|Combination of a cochlear implant and a hearing aid
15980701|NCT03031652|Device|Phacoemulsification|The device device used to provide and perform small profile entry for cataract extraction with or without option of insertion of a specified intraocular lens implant
15980702|NCT03031639|Procedure|Endoscopic approach thyroidectomy|Thyroid surgery using endoscopy.
15980703|NCT03031626|Biological|Medical Air vs Oxygen|Medical Air/Oxygen will be given
15980704|NCT03031613|Procedure|PEEP group|Application of 5cmH20 positive end expiratory pressure
15980705|NCT03031613|Procedure|ZEEP group|No application of positive end expiratory pressure
15980706|NCT03031600|Diagnostic Test|Radiodilution via Daxor BVA-100|The BVA-100 measures the hematocrit and residual plasma radioactivity of each sample in a semi-automated process, and the residual radioactivity is compared from that of the pre-injection sample to determine plasma volume. The plasma volume and BVA-100-measured hematocrit are then used to calculate the red cell volume and actual blood volume. The BVA-100 is FDA approved for blood volume measurement in vivo, has a reported precision of ± 2.5%, and has demonstrated accuracy and specificity in blood volume assessment in clinical and research settings (Van, P.Y., et al., 2011, Borovka, M., et al., 2013).
15980707|NCT03031600|Diagnostic Test|Hemodilution via hematocrit measurement|Hemodilution uses the ideal blood volume and serial hematocrit measures drawn before and after administration of a known quantity of IV fluid to estimate blood volume. Ideal blood volume is calculated using the methods described by Feldschuh and colleagues (Feldschuh, J. and Y. Enson, 1977; Feldschuh, J. and S. Katz, 2007). Hematocrit is measured using the Abbot iSTAT point of care testing device and the lab. Urine output is measured in ml. The ideal blood volume, pre and post-bolus hematocrit, fluid bolus volume, and urine output will be used to calculate estimated blood volume using a mathematical model previously described by the investigators (D'Angelo, M., et al., 2015).
15980708|NCT03031587|Other|Additional MRI acquisition sequences|It deals with specific sequences of rapid imaging acquisition in gradient echo (4 to 5 slices/cardiac cycle) with synchronization on the surface ECG systematically included in a cardiac MRI examination, together with update of the slice position depending on the respiratory state (established technique of navigator echo). The acquisition is repeated over 300 cardiac cycles to monitor myocardial temperature changes
15980709|NCT03031587|Device|MRI|cardiac MRI
15980710|NCT03031574|Drug|SUVN-D4010|Tablets
15980711|NCT03031561|Device|Ultrasound|Undergo standard ultrasound
15980712|NCT03031561|Device|MicoPure ultrasound|Undergo MicoPure ultrasound
15980713|NCT03031561|Procedure|Biopsy of Breast|Undergo breast biopsy or surgical resection
15980714|NCT03031548|Device|Point-of-care ultrasound exam|No intervention
15980715|NCT03031548|Radiation|Reposition ETT|ETT will be repositioned based on CXR by fluoroscopy
15980716|NCT03031535|Drug|Intranasal octreotide acetate|Intranasal spray of octreotide acetate
15980717|NCT03031535|Drug|Subcutaneous octreotide acetate|Subcutaneous injectable solution of octreotide acetate
15980718|NCT03031535|Diagnostic Test|Growth hormone-releasing hormone|Part of the well established GHRH/Arginine challenge to detect GH deficiency.
15980719|NCT03031535|Diagnostic Test|Arginine hydrochloride|Part of the well established GHRH/Arginine challenge to detect GH deficiency.
15980720|NCT03031522|Radiation|18F-IRS|According to experiment, 18F-IRS was non-toxic and stable in serum.
15980721|NCT03031509|Biological|Human Amniotic Epithelial Cells|Human Amniotic Epithelial Cells transplant after debridement
15980722|NCT03031509|Procedure|debridement|debridement
15980723|NCT03031496|Drug|GSK3542503 (HCTZ 50mg/Amiloride HCl 5mg tablets)|"GSK3542503 (HCTZ 50mg/Amiloride HCl 5mg tablets) are cream-colored, circular, flat faced uncoated tablets with beveled edges having break line on one side and BD embossed on the other side."
15980724|NCT03031496|Drug|Moduretic (HCTZ 50mg/Amiloride HCl 5mg tablets)|"Moduretic (HCTZ 50mg/Amiloride HCl 5mg tablets) tablets are peach-colored, half scored, diamond shaped tablets marked MSD917."
15980768|NCT03031158|Behavioral|SFEX+H|Participants will receive an intervention consisting of heat to the low back, manual therapy to the hip (including movement of the hip by the therapist), hip-focused strengthening exercises and a trunk muscle training program including exercises for the abdominal and low back muscles. The intervention will be delivered twice weekly for 8 weeks.
15980725|NCT03031483|Drug|clarithromycin and lenalidomide|"Each treatment course will consist of:
~Oral Lenalidomide (Revlimid) once daily for 21 days at a dose 20 mg; in case of drug-related adverse events the dose can be reduced to 15 and 10 mg/day; Oral Clarithromycin 500 mg twice daily for 28 days. Courses will be repeated every 28 days. After the first 3 courses patients with stable disease or better response will be given another three courses. Patients with complete remission or disease progression after 6 courses will be taken off study, while patients with partial response or stable disease will receive 3 further courses of treatment. Again, patients with complete response or disease progression will stop therapy, while patients with partial response/stable disease will receive 3 further courses up to a maximum of 12 courses in total."
15980726|NCT03031470|Drug|Reparixin|Reparixin 168 hrs continuous infusion
15980727|NCT03031470|Other|Standard care procedures|Standard procedures for administration of Immunosuppressive and support post transplant therapies
15980728|NCT03031457|Diagnostic Test|Duplex ultrasound|Duplex ultrasound of lower extremity venous system
15980729|NCT03031444|Drug|Cetuximab plus FOLFIRI/FOLFOX|cetuximab was added into the routine perioperative chemotherapy(FOLFIRI/FOLFOX) to evaluate its safety and efficacy
15980730|NCT03031444|Drug|FOLFIRI/FOLFOX/CapeOX|to evaluate its safety and efficacy of routine perioperative chemotherapy(FOLFIRI/FOLFOX/CapeOX)
15980731|NCT03031431|Device|Non-Electric Infant Warmer|Electric warmers are the standard of care in developed countries, but are extremely costly, complicated with risk of causing both hypo and hyperthermia with misuse, and often not feasible in settings without stable electricity. Through a multi-institutional collaboration, the investigators have developed an electricity-free infant warmer.
15980732|NCT03031418|Diagnostic Test|ExoDx Prostate Intelliscore|ExoDx Prostate (IntelliScore) is a non-invasive, urinary 3-gene expression validated test in which the results of the assay are adjunctive to the ordering physician's clinical judgment and work-up of the patient in the determination of whether a prostate needle biopsy is necessary. The ExoDx Prostate (IntelliScore) was clinically validated to discriminate patients with higher grade prostate cancer from those with more indolent lower grade cancer and benign disease.
15980733|NCT03031405|Drug|Oxytocin nasal spray|
15980734|NCT03031405|Drug|Placebos|Placebo nasal spray
15980735|NCT03031392|Diagnostic Test|Sensitivity test|Routine clinical and radiographic examination
15980736|NCT03031379|Other|shortened fast|fast of 45 minutes prior to surgery as opposed to standard 6 hour fast
15980737|NCT03031366|Other|3d roadmap guidance|TIPS was established using 3d roadmap
15980738|NCT03031366|Other|conventional TIPS procedure|conventional TIPS procedure using wedged hepatic venography
15980739|NCT03031353|Drug|Misoprostol|Misoprostol is given before elective cesarean section as prophylaxis against post partum hemorrhage
15980740|NCT03031353|Drug|Placebos|placebos tablet will be given before elective Cesarean sections
15980741|NCT03031340|Drug|Pregabalin|On the day of the surgery, 1hour + 15 minutes before the surgery starts, the subject will receive either 300mg of pregabalin or a similarly packaged placebo. On post operative day one, 150 mg of pregabalin or placebo will be given in two doses 12hrs apart.
15980742|NCT03031340|Other|placebo|placebo
15980743|NCT03031327|Device|Lubricin 20µg/ml eye drops|Lubricin 20µg/ml eye drops 3 times per day
15980744|NCT03031327|Device|Lubricin 50µg/ml eye drops|Lubricin 50µg/ml eye drops 3 times per day
15980745|NCT03031327|Device|Sodium hyaluronate (HA) 0.18% eye drops|Sodium hyaluronate (HA) 0.18% eye drops 3 times per day
15980746|NCT03031314|Device|barbed suture|
15980747|NCT03031314|Device|standard suture|
15980748|NCT03031301|Device|Vibrant capsule|One Vibrant capsule will be ingested 5 times per week for 8 weeks of treatment.
15980749|NCT03031301|Device|Sham capsule|One Sham capsule will be ingested 5 times per week for 8 weeks of treatment.
15980750|NCT03031288|Device|A|standard bottle
15980751|NCT03031288|Device|B|vented base bottle
15980752|NCT03031275|Radiation|High-resolution computed tomography|HRCT of the thorax
15980753|NCT03031275|Radiation|Magnetic resonance imaging|MRI of the brain
15980754|NCT03031275|Behavioral|Cognitive testing|Neuropsychological testing
15980755|NCT03031262|Drug|Cytarabine|Cytarabine at a dose of 3g/㎡/d on the first, third and fifth day.
15980756|NCT03031262|Drug|Chidamide|Chidamide at a dose of 20mg/d twice a week for 3 months.
15980757|NCT03031249|Drug|Cytarabine|Cytarabine at a dose of 3g/㎡/d on the first, third and fifth day.
15980758|NCT03031249|Drug|all-trans retinoic acid|ATRA at a dose of 30mg/㎡/d on day 1-14.
15980759|NCT03031249|Drug|Arsenic Trioxide|ATO at a dose of 10mg/d on day 1-14
15980760|NCT03031236|Behavioral|Psychosocial stimulation, Cognitive behavioral therapy and positive parenting practice|The mothers of intervention (ECD+HN) group will receive fortnightly group sessions for 12 months that will include combined messages on a) psychosocial stimulation, b) positive parenting to prevent child maltreatment and c) cognitive behavioural therapy (CBT) for positive thinking, d) health and nutrition messages and e) 15 micronutrient sprinkle supplement.(90 sachets of over 6 month-period)
15980761|NCT03031223|Radiation|low-level laser therapy|low-level laser therapy
15980762|NCT03031210|Drug|Amoxicillin|(90 mg/kg/day) twice daily
15980763|NCT03031197|Combination Product|Tailored realtime triggered reminder pkg|"Core intervention: 1) real time, personalized wireless reminder messages when ART doses are not taken on time, and 2) 'feedback' on adherence behavior via monthly interactive counseling sessions informed by summaries of their previous month's behavior. Personalized features of the intervention will be selected by each patient and may include 1) reminders sent to the WPC (light or chimes) or to patient's or caregiver's cell phone if dose is late; 2) content of text messages from a menu of options; 3) use of youth-friendly WPC adherence reports for interactive counseling sessions; 4) additional counseling by clinic staff; 5) a buddy system, by choosing someone to review the adherence report with him/her; and 6) a reward message after a pre-selected time period of excellent adherence."
15980764|NCT03031184|Drug|Mirtazapine|
15980765|NCT03031184|Other|Placebo|
15980766|NCT03031171|Behavioral|Screening patient navigation|The program offered assistance with scheduling, paperwork, arranging transportation, answering questions and providing education about screening and colorectal cancer.
15980767|NCT03031171|Behavioral|Non-Navigated|Randomly matched sample of non-navigated clinic patients
15980769|NCT03031158|Behavioral|SFEX|Participants will receive an intervention consisting of heat to the low back, manual therapy to the hip (including movement of the hip by the therapist) and a trunk muscle training program including exercises for the abdominal and low back muscles. The intervention will be delivered twice weekly for 8 weeks.
15980770|NCT03031145|Biological|Felis Domesticus|Nasal Administration of Felis Domesticus
15980771|NCT03031132|Behavioral|HP-Beverage Breakfast|Participants will consume high protein beverage (shake) breakfast meals each morning.
15980772|NCT03031132|Behavioral|HP-Solid Breakfast|Participants will consume high protein solid (traditional food items) breakfast meals each morning.
15980773|NCT03031132|Behavioral|Breakfast Skipping|Participants will skip breakfast each morning.
15980774|NCT03031119|Drug|Placebo|Tablets administered once or twice daily, with food, in Part A.
15980775|NCT03031119|Drug|PF-06835919|Tablets administered once or twice daily, with food, in Part A. Tablets administered once or twice daily, with food and atorvastatin in Part B.
15980776|NCT03031119|Drug|atorvastatin|In Part B, tablets administered once or twice daily, with food, with and without PF-06835919.
15980777|NCT03031093|Radiation|inhalation protocol|technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution
15980778|NCT03031093|Device|High Flow Nasal Cannula|aerosol solution of technetium labeled diethylenetriaminepenta-acetic acid (99mTc-DTPA) (1mCi) and bronchodilators (fenoterol (2.5 mg) and ipratropium bromide (0.25 mg)) with 0.9% saline solution (total 1,5 ml) using a vibrating MESH inhaler (Aerogen® Solo, Aerogen Ltd, Galway, Ireland). A High Flow Nasal Cannula will deliver the aerosol at a 30L/min flow of oxigen.
15980779|NCT03031080|Device|Thermoplastic Hand Splint|Thermoplastic Night splint created and moulded to the individual patients hand in-house using generic thermoplastic.
15980780|NCT03031067|Device|Machine perfusion|"The graft preservation will be performed perfusing with a oxygenated solution of preservation at 4°C for two hours with Exiper, Bologna Machine Perfusion, developed by Medica s.p.a and our research group.
~Flow and pressure values will be set up for the kidney and liver perfusion, differently. The oxygenation of solution will be performed by an oxygenator and a filter for decapneization / oxygenation. During the perfusion the oxygen pressure will be required between 600-750 mmHg (pO2 80-100 Kpa), as reported in the scientific literature. The pH, lactate concentration, and oxygen (PO2) and carbon dioxide (PCO2) partial pressure were measured in the preservation solution at T0 and T1 by means of a standard haemogasanalyzer."
15980781|NCT03031054|Procedure|Sono-guided injection with hyaluronic acid|Sono-guided injection with hyaluronic acid (ARTZDispo, 25 mg/2.5 ml) between carpal tunnel and median nerve
15980782|NCT03031054|Procedure|Sono-guided injection with normal saline|Sono-guided injection with 2.5cc Normal saline (0.9%) between carpal tunnel and median nerve
15980783|NCT03031041|Procedure|Ultrasound-guided short-axis hydrodissection with 5cc normal saline|Ultrasound-guided short-axis hydrodissection with 5cc normal saline between carpal tunnel and median nerve
15980784|NCT03031041|Procedure|Ultrasound-guided long-axis hydrodissection with 3cc normal saline|Ultrasound-guided long-axis hydrodissection with 3cc normal saline between carpal tunnel and median nerve
15980785|NCT03031028|Other|ketogenic diet|Ketogenic Diet is a high fat, low carbohydrate diet.
15980786|NCT03031015|Device|Cemented K-wire Fixation|Fractures were reduced and then fixed with cemented K-wires.
15980787|NCT03031015|Device|Plating|Fractures were reduced and then fixed with Plate.
15980788|NCT03031002|Behavioral|Exposure treatment for spider fear|Two sessions (each session = 60 minutes) of in-vivo exposure treatment (including psychoeducation) with two different spiders. Exposures comprise a hierarchy of 7 steps, to be completed with both spiders.
15980789|NCT03030989|Drug|Chlorhexidine Gluconate 2% Wipe|
15980790|NCT03030989|Drug|Placebo Wipe|
15980791|NCT03030976|Drug|cyclophosphamide|Patients receive cyclophosphamide (Cy) on day -2 and day -1 to reduce B cells. The dose is 0.5g/m2/d.
15980792|NCT03030976|Drug|anti-CD19-CAR-T cells|A 2nd CAR, CD19 as target protein, 4-1BB as co-stimulator, and optimized the spatial conformation by a suitable hinge & transmembrane domain sequences. Patients infused with anti-CD19-CAR-T cells transduced with lentivirus on day 0 in the absence of disease progression or unacceptable toxicity to treatment of SLE. The dose is 1E6~1E7 CD19-CAR positive T cells. The cells infusion process may last for 30 min.
15980793|NCT03030963|Other|Equal ratio ventilation(ERV)|Set the inspiratory to expiratory ratio 1:1 during mechanical ventilation
15980794|NCT03030963|Other|"I:E Ratio 1:2"|Set the inspiratory to expiratory ratio 1:2 during mechanical ventilation
15980795|NCT03030950|Drug|Dexmedetomidine|to investigate the effect of dexmedetomidine on motor and sensory properties of adductor canal block
15980796|NCT03030950|Drug|Normal saline|to give normal saline to the other group as a placebo
15980797|NCT03030937|Drug|Apatinib|Apatinib, a novel targeted inhibitor of VEGF receptor 2 (VEGFR2).
15980798|NCT03030937|Drug|Irinotecan|Irinotecan was used as second line treatment with AGC.
15980799|NCT03030924|Device|Solace|Noninvasive physiologic monitor
15980800|NCT03030911|Drug|Dexmedetomidine|The drug will be administered for sedation and its effect on basal metabolic rate will be investigated
15980801|NCT03030911|Drug|Midazolam|The drug will be administered for sedation and its effect on basal metabolic rate will be investigated
15980802|NCT03030911|Drug|Fentanyl|The drug will be administered in both groups
15980803|NCT03030911|Device|Indirect calorimetry|The device will be used for measurement of basal metabolic rate
15980804|NCT03030898|Diagnostic Test|respiratory variation of the right internal jugular vein|respiratory variation of the right internal jugular vein vs respiratory variation of superior and inferior cava vena
15980805|NCT03030885|Drug|131I-MIP-1095|"First Therapeutic Dose with 131I-MIP-1095 to be administered no later than 30 days after dosimetry dose, which will be designated Day 1 of the Treatment Phase 2nd and 3rd Therapeutic Doses with 131I-MIP-1095 to be administered 12 weeks apart Monthly Follow-Up Visits until Week 41. 1st Therapeutic Dose with 131I-MIP-1095 to start after qualifying from dosimetry on Day 8 or no later than 30 days after dosimetry dose.
~2nd and 3rd Therapeutic Doses with 131I-MIP-1095 to be administered 12 weeks apart Monthly Follow-Up Visits until Week 53"
15980806|NCT03030872|Device|Investigational software|The study evaluated retrospective de-identified cases that were processed after the imaging procedure had been completed (off-line) using a dedicated workstation.
15980808|NCT03030859|Other|Usual Care plus LEF-SCP|Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, as well as review LEF self-care educational manual and videos
15980809|NCT03030859|Other|Usual Care plus LEF-SCP plus Follow-up|Undergo Motivational Interviewing sessions and LEF Self-Care Training sessions, and review LEF self-care educational manual and videos, as well as meet with the study lymphedema therapist
15980810|NCT03030846|Other|Stabilization exercise|18 sessions during 6 consecutive weeks, three times per week, 30 or 40 minutes per session including: Twenty minutes for receiving hot pack and TENS and 10 or 20 minutes for training the exercises in 7 level : 1.Train the specific contraction of the deep abdominal muscles, multifidus and pelvic floor muscles(PFM). 2.Train the specific contraction of deep abdominal muscles with coactivation of multifidus and PFM in supine, prone, sitting, standing and quadruped position. 3. Segmental control exercises in close kinematic chain. 4. Segmental control exercises in open kinematic chain with limb loading, emphasis on abdominal muscles. 5. Segmental control exercises in open kinematic chain with limb loading, emphasis on back extensor muscles. 6. Progress exercises to functional task. 7. Coactivation of abdominal and multifidus muscles with limb loading in aerobic tasks.
15980811|NCT03030846|Other|Control group|8 sessions during 6 consecutive weeks, three times per week, per session including: Twenty minutes for receiving hot pack and TENS
15980812|NCT03030833|Device|Pulse Oximeter|Comparison of pulse oximetry to blood gas analyzer.
15980813|NCT03030820|Procedure|Dental Cleaning|This is standard of care dental cleaning as is guided by the initial dental evaluation
15980814|NCT03030807|Diagnostic Test|Right heart catheterization (in case of suspected PH)|
15980815|NCT03030794|Device|Repetitive transcranial magnetic stimulation|A non-invasive method of brain stimulation that emits a magnetic pulse.
15980816|NCT03030794|Device|Repetitive transcranial magnetic stimulation (sham)|No brain stimulation will be administered.
15980817|NCT03030768|Drug|PrEP|An integrated, phased safer conception intervention that focuses on ART use by the HIV-1 infected partner, PrEP use by the HIV-1 uninfected partner, and timed condomless sex during the peri-conception period.
15980818|NCT03030768|Behavioral|Counseling on timed condomless sex, ART and PrEP adherence|An integrated, phased safer conception intervention that focuses on ART use by the HIV-1 infected partner, PrEP use by the HIV-1 uninfected partner, and timed condomless sex
15980819|NCT03030755|Other|Optical coherence tomography|
15980820|NCT03030742|Other|Survey|"A survey will be administered at two time points (time of hospital discharge and 2-4 weeks postpartum) to determine:
~Satisfaction with pain control 2-4 weeks postpartum
~Patient-reported use of opioid medication postpartum (receipt of prescription, filling of prescription, if refill was obtained, and number of opioid pills remaining at the time of follow-up)
~Patient characteristics associated with high opioid use
~Methods of storage and disposal of unused opioids"
15980821|NCT03030716|Dietary Supplement|95% condensed proanthocyanidins from grape seed extract|0.03, 0.25, and 1.5 g 95% condensed proanthocyanidins from grape seed extract consumed three times daily for 4 weeks each
15980822|NCT03030703|Dietary Supplement|phytic acid|350 mg phytic acid (inositol hexaphosphate) three times daily for four weeks
15980823|NCT03030690|Other|Glass Carbomer Cement|Restoration of proximal lesions in primary molars using glass carbomer cement
15980824|NCT03030690|Other|Composite Resin|Restoration of proximal lesions in primary molars using composite resin.
15980825|NCT03030690|Other|Resin Modified Glass Ionomer Cement|Restoration of proximal lesions in primary molars using resin modified glass ionomer cement
15980826|NCT03030677|Procedure|Pectoralis II block & catheter without Lidocaine dissection|B Braun Catheter Kit Contiplex with a 18 gauge needle will be used. After topicalization of the skin and sterilization using ultrasound guidance to facilitate performing insertion of the canula. Confirming the tip position will be done by ultrasonography while performing pectoralis type 2 block for cases undergoing simple mastectomy procedures
15980827|NCT03030677|Procedure|Pectoralis II block & catheter with Lidocaine dissection|B Braun Catheter Kit Contiplex with a 18 gauge needle will be used. After topicalization of the skin and sterilization using ultrasound guidance to facilitate performing insertion of the canula. 10 ml of lidocaine 1% will be injected for plan dissection to facilitate the procedure. Confirming the tip position will be done by ultrasonography while performing pectoralis type 2 block for cases undergoing simple mastectomy procedures
15980828|NCT03030677|Other|catheter insertion|catheter insertion after Lidocaine dissection
15980829|NCT03030664|Dietary Supplement|L.reuteri|Each day, at about the same time, the subjects will be given 5 drops (1x10^8 CFU) of the study product in connection with feeding
15980830|NCT03030664|Drug|Placebo|Same formulation as study product, without probiotics.
15980831|NCT03030651|Behavioral|Breastfeeding Education and Support|Women Development Army (WDA) leaders will function as peers for mothers in intervention group. There will be two visits during pregnancy and 8 visits postnatally. During pregnancy, WDA leaders will cover in detail the importance of EBF, feeding colostrum first, and discouraging prelacteal foods and encourage the mother to deliver at the nearby health center. During Postnatal visits, mothers will be observed positioning, attaching, and feeding the new-born, with appropriate feedback provided, solving any BF problems, encourage the mothers to continue exclusive breastfeeding for 6 months, emphasize nutrition for sufficient breast milk to breastfeed successfully and hands-on guidance only when necessary.
15980832|NCT03030638|Drug|Olodaterol|Drug
15980833|NCT03030638|Drug|Indacaterol|Drug
15980834|NCT03030625|Radiation|IGRT/VMAT focal therapy boost to DIL|Image-guided/VMAT focal Intensification dose to intraprostatic dominant lesion in men with localized prostate cancer (PCa) of intermediate and high risk (criteria NCCN) eligible to receive radiotherapy
15980835|NCT03030612|Drug|ARGX-110|ARGX-110 will be administered intravenously.
15980836|NCT03030612|Drug|AZA|AZA will be administered subcutaneously/intravenously.
15980837|NCT03030599|Drug|JZP-258|JZP-258 oral solution 0.5 g/mL, which is equivalent to 0.413 g/mL of oxybate
15980838|NCT03030599|Other|Placebo|Matching placebo solution (aqueous solution containing sodium citrate, malic acid, and sucralose; all ingredients were compendial [United States Pharmacopeia/ National Formulary])
15980839|NCT03030573|Procedure|Reconstruction of the bile duct with the round ligament|In patients who had bile duct defect by injury or resection, the Round ligament will be used to reconstruct the defect. Surgical technique, the early and long term postoperative measures are detailed in the investigators protocol.
15980840|NCT03030560|Drug|Lidocaine|patients (n = 20) will receive a loading dose of lidocaine 2 mg ̸ kg slowly IV just before induction of anesthesia, then the lidocaine infusion started at a rate of 3 mg ̸ kg/h, and continued until the end of the operation.
15980841|NCT03030560|Drug|0.9% Sodium-chloride|patients (n = 20) will receive an equal volume of 0.9% saline (both the loading and the infusion), the infusion will be initiated at the time of induction of anesthesia and continued until the end of the operation.
15980842|NCT03030547|Device|SenseWear activity monitor|Individuals will wear SenseWear activity monitors on right triceps muscle for 5 days. The data stored on the device will be recorded in computer using the software. Individuals will be given information of the resulting data (total number of steps, total energy expenditure, the number of daily steps and energy expenditure, physical activity duration in different intensity).
15980845|NCT03030521|Diagnostic Test|the aortic delamination test|The aortic delamination test will be performed in the dissected tissue of all patient. The processes of this test has been descripted in the summary.
15980846|NCT03030508|Other|No intervention|
15980847|NCT03030495|Device|Comprehensive physiologic evaluation|Comprehensive physiologic evaluation using pressure-temperature sensor wire to measure fractional flow reserve, coronary flow reserve, index of microcirculatory resistance
15980848|NCT03030495|Device|Intravascular imaging devices|Intravascular ultrasound or optical coherence tomography
15980849|NCT03030482|Procedure|touch massage|Patients will have a touch massage session during 30 minutes the intervention will take place remotely (1 h) of all events that can generate anxiety
15980850|NCT03030469|Other|Change in electronic health record default for new opioid analgesic prescriptions|
15980851|NCT03030456|Device|Power Plate®|Training of elderly women with Whole Body Vibrations through the use of a vibratory platform.
15980852|NCT03030430|Biological|BAT1706 injection|1mg/kg, IV on day 1
15980853|NCT03030430|Biological|EU-sourced Avastin|1mg/kg, IV on day 1
15980854|NCT03030430|Biological|US-sourced Avastin|1mg/kg, IV on day 1
15980856|NCT03030391|Other|PET|
15980857|NCT03030391|Other|MRI|
15980860|NCT03030365|Device|"Siemens Biograph mMR PET-MR (3T)"|Standardly used Magnetic resonance imaging (MRI) protocols, including resting state fMRI, task fMRI, T1 weighted imaging. In addition Patients will receive an intravenous injection of 2-5mCi of 18F-FDG prior to PET MRI.
15980861|NCT03030352|Behavioral|How-to Parenting Program|The How-to Parenting Program addresses all three key dimensions of optimal parenting; autonomy support, affiliation and structure. With weekly workshops, the How-to-Parenting Program optimizes learning by (1) linking group content with parents' needs, (2) facilitating awareness with perspective taking activities, (3) offering concrete parenting skills, (4) modeling the skills and providing practice in a predictable and non-judgmental environment, (5) emphasizing the importance of implementing these skills at home for long term behavioral change, and (6) offering tools (i.e., exercise booklet, skill summary) that facilitate information retention.
15980862|NCT03030339|Other|High VA intake, recent VAS|Children who are exposed to multiple VA programs, have received a high-dose VA supplement (VAS; 200,000 IU) in the past month, and are identified as being likely to have chronic excessive dietary VA intake.
15980863|NCT03030339|Other|High VA intake|Children who are exposed to multiple VA programs, have received a high-dose VA supplement (200,000 IU) in the past 3-6 months, and are identified as being likely to have chronic excessive dietary VA intake.
15980864|NCT03030339|Other|Low/adequate VA intake|Children who are not exposed to multiple VA programs, have received a high-dose VA supplement in the past 3-6 months, and are identified as being likely to have chronic low to adequate dietary VA intake.
15980865|NCT03030326|Behavioral|heart rate variability biofeedback|Patients learn to increase heart rate variability by breathing at the resonance frequency of the cardiovascular system, at approximately 6 breaths/min, varying among people.
15980866|NCT03030313|Device|Reassure Non-Contact Respiration Monitor|Reassure Respiration Monitor uses very low power radio waves to detect respiratory movements of a person while asleep in bed - without physical contact with the individual. Algorithms analyze the respiratory movement signals and extract information about respiration rate and variability. This data is uploaded to a secure cloud infrastructure for storage.
15980867|NCT03030300|Drug|Novolin 30R;Pioglitazone;Metformin|"Insulin (Novolin 30R) was titrated according to the level of blood glucose until reached euglycemia (FPG≤6.1mmol/L and/or P2hBG≤8.0mmol/L and/or HbA1c ≤6.5%). After glucose was well controlled within these targets for 4 weeks, insulin dosage was gradually decreased until discontinued;
~Pioglitazone hydrochloride was discontinued if the glucose was well controlled at the 6th week after the cessation of insulin;
~Metformin was the last drug that to be discontinued if the glucose was still well controlled at the 4th week after the cessation of pioglitazone."
15980868|NCT03030287|Drug|OMP-305B83|intravenous (in the vein) infusion
15980869|NCT03030287|Drug|Paclitaxel|administered intravenously
15980870|NCT03030274|Device|Occlutech AFR device|Catheter-guided placement of an AFR device following balloon atrial septostomy.
15980874|NCT03030248|Drug|Vancomycin Oral Capsule|We have chosen oral vancomycin capsules as it is currently a standard of care for Clostridium difficile infections, is poorly absorbed by the intestines, and is easier to blind compared to oral vancomycin solution.
15980875|NCT03030248|Drug|Placebo Oral Capsule|A capsule containing gelatin, polyethylene glycol, titanium dioxide, iron oxide, and FD&C blue No. 2. Contains the inactive ingredients of the vancomycin oral capsule, as mixed by the Froedtert Health Research Pharmacy.
15980876|NCT03030235|Drug|Dapagliflozin 10Mg Oral Tablet|Dapagliflozin 10Mg Oral Tablet
15980877|NCT03030235|Drug|Dapagliflozin matching placebo|Dapagliflozin matching placebo
15980878|NCT03030222|Drug|Empagliflozin 10Mg Tab|Empagliflozin 10Mg Tab
15980879|NCT03030222|Drug|Placebo Oral Tablet|Empagliflozin matching placebo
15980880|NCT03030209|Procedure|Distal pancreatectomy|Distal pancreatectomy with or without splenectomy using minimal invasive or open approach
15980881|NCT03030196|Drug|Denosumab|NaCl 0.9% injection is used as placebo
15980882|NCT03030183|Drug|Zilucoplan (RA101495)|0.3 mg/kg subcutaneously (SC) at Day 1 (loading dose) followed by a starting maintenance dose of 0.1 mg/kg daily SC
15980883|NCT03030170|Device|ENDO GIA X-tra Thick reload with Tri Staple Technology|Suture of the pancreas by normal stapling
15980884|NCT03030170|Device|ENDO GIA Articulating Reinforced Reload with Tri-Staple Technology|Suture of the pancreas by reinforced stapling
15980885|NCT03030157|Drug|pirarubicin(THP)|
15980886|NCT03030144|Other|Evidence based nursing recommendations|The intervention group gets the evidence based nursing interventions for the conservative management of urinary incontinence in female nursing homes.
15980887|NCT03030131|Drug|Durvalumab|durvalumab 750 mg IV Day1, 15, 29
15980888|NCT03030118|Drug|Hydroxychloroquine|Hydroxychloroquine is classified as an anti-malarial and it is has immunomodulatory functions that make it useful for treatment of autoimmune disorders including systemic lupus erythematosus and rheumatoid arthritis.
15980889|NCT03030118|Drug|Placebo Oral Capsule|An oral capsule placebo is made to match the active intervention medication hydroxychloroquine.
15980890|NCT03030105|Drug|BPN14770|investigational drug
15980891|NCT03030105|Drug|BPN14770 placebo|placebo
15980892|NCT03030105|Drug|Donepezil|comparator
15980893|NCT03030105|Drug|Donepezil placebo|placebo
15980894|NCT03030105|Drug|Scopolamine 0.6 MG/ML|cognition impairment
15980895|NCT03030105|Drug|Scopolamine placebo|placebo
15980896|NCT03030092|Other|Maximal Strength Training|leg pres and abduction exercises
15980897|NCT03030079|Device|Experimental Electrical Stimulation Regimen|The electrodes will pass an electrical current through the skin and into the muscle first at a low intensity for 5 minutes to allow the subject to adjust to the sensation. The current will then be gradually increased to a level sufficient to elicit a non-painful motor contraction. The subject will sit in a relaxed position as the electrical stimulator contracts the muscles for a duration of 15 minutes.
15980898|NCT03030066|Drug|DS-1001b|Generic not assigned
15980899|NCT03030053|Dietary Supplement|Cocoa-Flavanol Supplements|3 capsules each containing 300mg cocoa flavanols (total daily dose of 900mg cocoa-flavanols).
15980900|NCT03030053|Dietary Supplement|Control Supplements|3 capsules each containing 0mg cocoa-flavanols
15980901|NCT03030040|Behavioral|The self-help book: Williams, M. & Penman, D. (2011). Mindfulness: A practical guide to finding peace in a frantic world. London: Piatkus.|Participants will be provided with a copy of the self-help book, and asked to read it and follow the activities outlined in it, over eight weeks. They will receive weekly standardized emails, to provide information about mindfulness and encouragement to engage with the self-help book.
15980902|NCT03030027|Behavioral|Connecting Through Caregiving|The Connecting Through Caregiving intervention focuses on reappraisal exercises on intergeneration relationships in caregiving, involving the following: 1) enhancing self-awareness of the caregiver, 2) developing interpersonal empathy for the care-recipient, 3) help-seeking in caregiving, 4) balancing self-care and caring and 5) negotiating action plans.
15980903|NCT03030027|Other|Basic Skills Building|Skill building involves: 1) monitoring activities, 2) pleasant event scheduling, 3) communicating with the care recipient, 4) communicating with family members and 5) review implementation
15980904|NCT03030014|Behavioral|educational programm|Oral health education will be done for children and their care givers about various diseases affecting the oral cavity, the effects of bad oral hygiene and tooth decay, importance of tooth brushing, and correct methods of tooth brushing.Three follow up examination is assessed after one week, three weeks and six weeks using questionnaire for evaluation of participant satisfaction about oral health and using OHIS index for evaluating the effect of the dental educational program on the oral health status of deaf children.
15980905|NCT03030014|Other|no educational program|without oral health education will be done for children and their care givers about various diseases affecting the oral cavity, the effects of bad oral hygiene and tooth decay, importance of tooth brushing, and correct methods of tooth brushing.Three follow up examination is assessed after one week, three weeks and six weeks using questionnaire for evaluation of participant satisfaction about oral health and using OHIS index for evaluating the effect of the dental educational program on the oral health status of deaf children.
15980906|NCT03030001|Biological|PD-1 antibody expressing mesothelin specific CAR-T cells|Patients will receive an IV infusion of PD-1 antibody expressing mesothelin specific CAR engineered peripheral blood leukocyte. On day 21, cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.
15980907|NCT03029988|Drug|Tilmanocept (Technetium Tc 99m tilmanocept Injection)|Drug: Technetium Tc 99m tilmanocept
15980908|NCT03029988|Procedure|SPECT/CT Imaging|4-6 hours post-injection SPECT/CT will be obtained in the abdominal region.
15981207|NCT03027908|Other|Fluoride Toothpaste 2|Toothpaste containing 1450 ppm F as Sodium Fluoride
15980909|NCT03029975|Behavioral|Resistance Training Exercise|Participants will undergo 10 weeks of progressive resistance exercise training while following their randomly assigned nutritional intervention.
15980910|NCT03029975|Behavioral|Beef Protein Consumption|Following each resistance training sessions, participants will consume either a 3oz or 6oz beef patty (corresponding to the randomly assigned nutritional intervention group). Participants will also be provided with beef protein powder and beef snack bars to help them achieve their assigned protein goals during the intervention period.
15980911|NCT03029962|Behavioral|Girl2Girl|"Girl2Girl is a text messaging-based teenage pregnancy prevention program specifically for 14-18 year old LGB adolescent females. Content is guided by the Information-Motivation-Behavioral Skills (IMB) model and focuses on: HIV information, motivations to engage in HIV preventive behavior, communication skills, behavioral skills (e.g., using a condom; HIV testing); and healthy/unhealthy relationships. Behavioral skills content is reinforced using brief online videos. The intervention is 7 weeks long. A booster is delivered 12-weeks post-intervention end and reviews the topics covered in the intervention. Girl2Girl content is tailored based upon sexual experience (i.e., whether one is abstinent or sexually active) and whether one is same-sex or dually attracted."
15980912|NCT03029949|Behavioral|ACT with VR|6 weekly 120-minute group sessions of acceptance and commitment therapy with vestibular rehabilitation, and brief (approximately 15 minute) individual follow-up sessions at 1 and 3 months after the group treatment
15980913|NCT03029949|Behavioral|self-treatment VR|booklet written on vestibular rehabilitation for self-treatment
15980914|NCT03029949|Other|clinical management|clinical management and pharmacotherapy as usual for chronic dizziness
15980915|NCT03029923|Behavioral|Experimental: Behavioral Activation Treatment for Cardiac Smokers (BAT-CS)|All participants will receive one hour of standard smoking cessation counseling during their hospitalization for an acute coronary syndrome. Participants will be randomized 1 week after discharge. Those assigned to BAT-CS condition will receive 5 more counseling sessions over the 12 weeks after discharge. The first will be up to one hour and will be conducted in person. The next 4 sessions will occur by phone and will take about 30 minutes. Post-discharge sessions will be focused on smoking cessation and mood management using behavioral activation techniques. Participants will be offered the nicotine patch if medically cleared.
15980916|NCT03029923|Behavioral|Smoking cessation plus Health and Wellness|All participants will receive one hour of standard smoking cessation counseling during their hospitalization for an acute coronary syndrome. Participants will be randomized 1 week after discharge. Those assigned to the Smoking cessation plus Health and Wellness condition will receive 5 more counseling sessions over the 12 weeks after hospital discharge. The first will be up to one hour and will be conducted in person. The next 4 sessions will occur over the phone and will take about 30 minutes. Post-discharge sessions will be focused on smoking cessation and didactic health and wellness education. Participants will be offered the nicotine patch if medically cleared.
15980917|NCT03029910|Other|Cryotherapy and eccentric exercise|12 weeks, 5 days/week, once a day, 2 exercises, 3 sets/exercise, 15 repetition/set. Of excentric exercise of foot plantar flexors. First exercise with knee in extension. Second exercise with knee in flexion. Previously subjects should cool their leg in ice water during sixteen minutes at a temperature of 8ºC (+/-2ºC)
15980918|NCT03029910|Other|Vibration and eccentric exercise|12 weeks, 5 days/week, once a day, 2 exercises, 3 sets/exercise, 15 repetition/set. Of excentric exercise of foot plantar flexors. First exercise with knee in extension. Second exercise with knee in flexion. During the exercise subjects will be subjected to vibration. Vibration parameters: Frequency: 35Hz, Amplitude: 4 millimeters, Force: 3,9G
15980919|NCT03029897|Other|My eReport France|"patients are educated to the use of My eReport France application"
15980920|NCT03029884|Device|Medtronic Activa PC+S|In Aim 2 we will perform closed loop DBS versus sham (randomized) to evaluate efficacy of stimulation for analgesia. In Aim 3, closed-loop DBS will be compared to open-loop DBS in a patient blinded, randomized fashion.
15980921|NCT03029871|Biological|Ad5-yCD/mutTKSR39rep-ADP Adenovirus|oncolytic adenovirus
15980922|NCT03029858|Other|No interventions will be taken in this Observational study|TAGRISSO(osimertinib/AZD9291）
15980923|NCT03029845|Drug|Propranolol 1|Participants will take 20 mg propranolol twice a day for 2 weeks
15980924|NCT03029845|Drug|Propranolol 2|Participants will take 10 mg propranolol twice a day for 2 weeks
15980925|NCT03029845|Drug|Placebo|Participants will take placebo twice a day for 2 weeks
15980926|NCT03029832|Drug|MOXR0916|MOXR0916, 300 milligram (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle.
15980927|NCT03029832|Drug|Atezolizumab|Atezolizumab, 1200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle.
15980928|NCT03029819|Behavioral|Mindfulness-based Addiction Treatment|Mindfulness-based Addiction Treatment (MBAT) consists of 8 weekly 2-hour sessions that teach mindfulness and cognitive-behavioral strategies for smoking cessation (Wetter et al., 2009).
15980929|NCT03029819|Behavioral|iQuit Mindfully|iQuit Mindfully involves text messages on each day between treatment sessions. The text messages provide mindfulness and cognitive-behavioral strategies and support for smoking cessation.
15980930|NCT03029819|Behavioral|Self-Help guide|Self-help materials for smoking cessation are based on the Treating Tobacco Use and Dependence Clinical Practice Guideline (Fiore et al. Clinical practice guideline for treating tobacco use and dependence, 2008).
15980931|NCT03029819|Drug|Nicotine Patch|Patch therapy (beginning the week before quit day) for participants who smoke >10 cigarettes/day will consist of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day will consist of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.
15980932|NCT03029806|Other|Aldosterone response to AngII LS|Change in aldosterone from baseline to after Ang II infusion on a LS diet
15980933|NCT03029806|Other|Renal blood flow response to salt|Change in renal blood flow: High salt to low salt diet
15980934|NCT03029806|Other|Vascular Stiffness|Change in vascular stiffness, baseline compared to AngII
15980935|NCT03029793|Other|Biomarkers Testing|CRT resistance biomarkers will be detected before CRT, 2-3 weeks after the initiation of CRT, and 4 weeks post-CRT.
15980936|NCT03029793|Other|Functional Imaging analysis|The SUV value and texture parameters of 18F-FDG PET-CT as well as ADC values DWI-MRI will be measures before CRT, 2-3 weeks after the initiation of CRT, and 4 weeks post-CRT.
15980937|NCT03029780|Biological|Opdivo|Specified dose on specified days
15980939|NCT03029767|Other|Aerobic exercise .|The aerobic exercise group will perform brisk walking. Intensity of the aerobic exercise program will be progressively increased throughout the 16-week program. Intensity of aerobic exercise will be 40-65% of maximum heart rate , which is low to moderate.Duration of each session will be 45 minutes. Aerobic exercise will be performed 3 days per week.
15980940|NCT03029767|Other|Resistance exercise|"The resistance exercise group will perform 8 different exercises. Frequency of exercises per week is 3 days and duration of each exercise session is 45minutes. Interval rest among different exercises is 1minute.The intensity and repetition of resistance exercises is progressive. Participants will be exercised at 30% intensity (low intensity) for upper body and 50% intensity (moderate intensity) repetition voluntary maximum for lower body.
~Progressive, dynamic and rhythmical, alternative to upper-body and lower-body works and circuit resistance training of low to moderate intensity exercises will be executed."
15980941|NCT03029767|Other|Aerobic and resistance exercise|The aerobic and resistance exercise group will perform 23 minutes aerobic exercises and 22 minutes resistance exercises. The exercises will be performed three days per week . Intensity of aerobic and resistance exercise group for aerobic and resistance exercises are similar with intensity of aerobic group and resistance group exercises respectively.
15980942|NCT03029754|Procedure|Passive leg raise|A baseline vein diameter will be obtained using ultrasound by the sub-investigator. Then a nurse will raise the child's legs using a bolster while a second measurement of the child's vein diameter is recorded by the sub-investigator. The anesthesiologist will then place the IV and rate the degree of difficulty encountered.
15980943|NCT03029741|Drug|AZD0284|Subjects will receive a single oral dose of 4 to 120 mg AZD0284 oral suspension 5 mg/mL in the fasted state
15980944|NCT03029741|Drug|[14C]AZD0284|Following administration of the AZD0284 oral suspension subjects will receive an IV infusion of 20 μg [14C]AZD0284 solution
15980945|NCT03029715|Drug|Propofol|Total intravenous anaesthesia.
15980946|NCT03029715|Drug|Remifentanil|Narcotics
15980947|NCT03029715|Drug|Dexmedetomidine|Total intravenous anaesthesia
15980948|NCT03029715|Drug|Desflurane|Inhalation anaesthesia.
15980949|NCT03029702|Drug|Insulin|Insulin will be used for GDM treatment
15980950|NCT03029702|Drug|Glyburide|Glyburide will be used for GDM treatment
15980951|NCT03029702|Drug|Metformin|Metformin will be used for GDM treatment
15980952|NCT03029689|Drug|Raltegravir|Raltegravir 1200 mg (2 tablets x 600mg) once daily plus current ART during 48 weeks from randomization
15980953|NCT03029689|Drug|Placebo|Placebo (2 tablets of placebo) once daily plus current ART during 48 weeks from randomization.
15980954|NCT03029689|Drug|Current ART|3-drug antiretroviral treatment including PI/r/c or NNRTI
15980955|NCT03029676|Drug|benzodiazepines|sedative
15980956|NCT03029676|Drug|opioid|analgetic, sedative
15980957|NCT03029676|Procedure|spinal anesthesia|
15980958|NCT03029663|Procedure|Transurethral resection of the bladder tumour|
15980959|NCT03029650|Drug|Transderm Scop®|TDDS dosage is 1.5 mg/72 hrs
15980960|NCT03029650|Drug|Intravenous scopolamine hydrobromide|0.4 mg via intravenous injection
15980961|NCT03029637|Device|RBBs with no or minimal preparation of their abutment teeth|Placement of resin bonded bridges on teeth with no or minimal cutting of their supporting teeth
15980962|NCT03029637|Device|RBBs with routine tooth preparation of their abutment teeth|Placement of resin bonded bridges on teeth after routine cutting of their supporting teeth
15980963|NCT03029624|Device|eCoin|Patients are implanted with active implantable device called eCoin. eCoin is turned ON in order to deliver neuromodulation therapy.
15980964|NCT03029611|Drug|Carboplatin|Given IV
15980965|NCT03029611|Procedure|Gynecological Surgical Procedure|Undergo cytoreductive surgery
15980966|NCT03029611|Other|Laboratory Biomarker Analysis|Correlative studies
15980967|NCT03029611|Drug|Paclitaxel|Given IV
15980968|NCT03029611|Biological|pUMVC3-hIGFBP-2 Multi-Epitope Plasmid DNA Vaccine|Given ID
15980969|NCT03029598|Drug|Carboplatin|Given IV
15980970|NCT03029598|Other|Laboratory Biomarker Analysis|Correlative studies
15980971|NCT03029598|Biological|Pembrolizumab|Given IV
15980972|NCT03029585|Drug|NanoPac® 100 mg/m2|Single intraperitoneal injection of 100 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
15980973|NCT03029585|Drug|NanoPac® 200 mg/m2|Single intraperitoneal injection of 200 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
15980974|NCT03029585|Drug|NanoPac® 300 mg/m2|Single intraperitoneal injection of 300 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
15980975|NCT03029585|Drug|NanoPac® 400 mg/m2|Single intraperitoneal injection of 400 mg/m2 NanoPac® during cytoreductive surgery, followed by standard-of-care IV carboplatin and IV paclitaxel treatment
15980976|NCT03029585|Drug|Standard of Care Intravenous Chemotherapy|Cytoreductive surgery followed by standard-of-care IV carboplatin and IV paclitaxel treatment
15980977|NCT03029572|Drug|Diet supplementation|Micronutriment supplementation therapy
15980978|NCT03029572|Procedure|Bariatric surgery|Roux-en-Y gastric bypass provided in both arms.
15980979|NCT03029559|Other|Intermittent Hypoxia|"A single session of IH will last for 45 minutes and will consist of alternating phases of hypoxia(FiO2 :9%-11%) and hyperoxia (FiO2 :22%-38%).
~Each hypoxic interval will last for 2 minutes whereas the hyperoxic interval lasts for 1 minute each (15, two-minute episodes of hypoxia and 15, one-minute episodes of hyperoxia)."
15980980|NCT03029559|Other|Inspiratory Threshold Loading|Subjects will undergo inspiratory threshold loading using a commercially available Threshold IMT device (Power breathe®). ITL will be administered at an intensity of 80% of the individual's maximal inspiratory pressure (MIP). The subjects will be instructed to take 10 deep, forceful breaths through the threshold device followed by at least 2 minutes of rest. The process will be repeated 4 more times for a total of 5 sets of 10 breaths each.
15980981|NCT03029559|Other|Sham Intermittent Hypoxia|Subjects will be exposed to a session of sham Intermittent hypoxia.This will consist of breathing room air for 45 minutes through a hypoxicator.
15980982|NCT03029533|Drug|Leuprolide Acetate|DWJ108J, SC injection, once(Day1)
15980983|NCT03029533|Drug|Leuprolide Acetate|Leuplin DPS Inj, SC injection, once(Day1)
15980984|NCT03029520|Other|Root canal obturation with iRoot SP sealer|Postoperative pain after root canal obturation with iRoot SP sealer with patients who has (mandibular premolar/molar) vital and devital pulps.
15980985|NCT03029520|Other|Root canal obturation with AH Plus Sealer|Postoperative pain after root canal obturation with AH Plus sealer with patients who has (mandibular premolar/molar) vital and devital pulps.
15980986|NCT03029507|Behavioral|ACT Enhanced ShipShape|The ACT components focus on: a) thoughts, feelings, and bodily sensations that are often present in the context of efforts to lose weight or improve fitness; b) limitations of previous efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness of experiences; and e) identification of personal values and setting and pursuing values-consistent goals in order to achieve improved quality of life.
15980987|NCT03029507|Behavioral|Standard ShipShape (SS)|The materials and format of the Standard SS-only protocol are based on recommendations from the Navy and Marine Corps Public Health Center. These include: a) education for nutrition and physical activity; b) creating and documenting goals for weight loss and physical fitness; c) a food diary to track eating habits throughout the program; d) developing behavioral strategies to initiate/maintain an exercise program; e) monitoring of physical activity (pedometer provided by the study); and f) identifying and overcoming personal triggers for over-eating.
15980988|NCT03029494|Device|stabilization splint|Hard acrylic type of splint with full coverage of occlusal surfaces of upper teeth, with a thickness of about 1.5 mm at the level of the first molar.
15980989|NCT03029494|Drug|Placebo Oral Tablet|sugar pill manufactured to mimic 1000 mg Vitamin C
15980990|NCT03029494|Device|placebo splint|Ineffectively designed oral appliance: an acrylic palatal plate will be used (without influence on occlusion, TMJ and masticatory muscles).
15980991|NCT03029494|Dietary Supplement|Vitamin C|1000 mg
15980992|NCT03029481|Drug|Ganitumab|The patient will receive ganitumab, 18 mg/kg/dose intravenously every 2 weeks until clinical progression or decision to move to an alternate therapy.
15980993|NCT03029468|Behavioral|cognitive behavioral therapy|CBT teaches users how to recognize negative thoughts and emotions, use cognitive skills and problem-solving, and apply coping behaviors such as distraction, activity scheduling, and relaxation.
15980994|NCT03029468|Behavioral|eEducation|Pain and sickle cell disease education delivered through a mobile electronic device
15980995|NCT03029455|Drug|VX-659|
15980996|NCT03029455|Drug|Tezacaftor|
15980997|NCT03029455|Drug|Ivacaftor|
15980998|NCT03029455|Drug|VX-659 Matching Placebo|
15980999|NCT03029455|Drug|Triple Combination (TC) Matching Placebos|
15981000|NCT03029442|Drug|Denosumab (Prolia)|In clinical trials, denosumab (Amgen Inc., Thousand Oaks, CA), has been shown to be more potent in reducing osteoclastosis and function than bisphosphonates. The dose of denosumab chosen for our protocol in patients after acute SCI will be the same dose that has been shown to be efficacious to treat postmenopausal osteoporosis (60 mg SQ q 6 months).
15981001|NCT03029442|Other|Placebo (normal saline)|Identical Denosumab volume of normal saline
15981002|NCT03029429|Drug|Theophylline|oral theophylline
15981003|NCT03029429|Drug|Placebos|oral placebo
15981004|NCT03029416|Radiation|Stereotactic Body Radiation Therapy|Stereotactic Body Radiation Therapy using different fractionation schedules
15981005|NCT03029403|Drug|Pembrolizumab|Given intravenously in clinic, at 200 mg, on Day 1 of every 21-day cycle.
15981006|NCT03029403|Biological|DPX-Survivac|Given by injection under the skin of the upper thigh in clinic. Participants will receive one priming dose of 0.25 mL of DPX-Survivac on Cycle 1 Day 1. After about 6 weeks, participants will receive an additional boosting dose of 0.25 or 0.5 mL DPX-Survivac.
15981007|NCT03029403|Drug|Cyclophosphamide|Given orally, at 50 mg, twice a day, starting about 7 days before Cycle 1 Day 1, then continue 7 days off, 7 days on.
15981008|NCT03029390|Dietary Supplement|Berberine|"Berberine capsules, 500 mg, three per day before each meal during 14 weeks.
~The patients will have a running period during two weeks:
~First week they will receive one 500 mg capsule before breakfast Second week they will receive two 500 mg capsules (before breakfast and meal) From the third week until the end of the study (14 week), they will be receive three 500 mg"
15981009|NCT03029390|Drug|Metformin|"Metformin capsules, 850 mg, two per day before breakfast and dinner and one placebo capsule before lunch during 14 weeks.
~The patients will have a running period:
~First week they will receive one 850 mg capsule before breakfast Second week they will receive one 500 mg capsules (before breakfast) and one placebo capsule (before meal).
~From the third week until the end of the study (14 week), they will be receive two 850 mg capsules (before breakfast and dinner) and one placebo capsule (before meal)."
15981010|NCT03029377|Other|Posture Study, Autonomic Function Tests, and a Stress Test|Participants will undergo a Posture Study, Autonomic Function Tests, and a Stress Test. Participants' blood will be drawn to measure markers of sympathetic nervous system function at baseline, in three postural positions, after autonomic tests, and after a stress test.
15981011|NCT03029364|Behavioral|Study Protocol|"Participants will complete three study protocols 7 - 28 days apart which includes:
~3 x main trial days (max. 150 mins) involving body composition analysis, indirect calorimetry, a blood sample, optional muscle and / or adipose tissue biopsies and a maximal cardiorespiratory fitness test.
~2 x lifestyle monitoring periods (physical activity and diet) for the prior 7 days before each main trial day.
~Maintenance of habitual habits, dietary and physical activity behaviour patterns
~We are observing biological / health parameters in a group of individuals who will be assessed under resting and exercising conditions. The current study does not involve an intervention."
15981012|NCT03029351|Drug|Exenatide Extended Release for Inj Susp 2 MG|Exenatide extended release treatment weekly for 1 year in T2DM patients with micro- and macroalbuminuria
15981013|NCT03029351|Drug|Placebos|placebo treatment weekly for 1 year in type 2 diabetes with micro-and macroalbuminuria
15981014|NCT03029338|Biological|CD19 CAR T cells|CD19 CAR T cells was transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:4-1BB.
15981124|NCT03028467|Drug|Placebo|Placebo is supplied as liquid as sterile 0.9% sodium chloride solution and will be administered as SC injection.
15981125|NCT03028467|Drug|Folic acid|Folic acid tablet 5 mg per week is given orally.
15981208|NCT03027895|Device|Lumen-apposing metal stent (LAMS)|Endoscopic Ultrasound-guided Drainage of WON with LAMS
15981015|NCT03029312|Device|Galileo M|Motorized board producing side-to-side alternating vertical sinusoidal (rotational) vibrations around a fulcrum in the mid-section of the plate. The vibration frequency can be selected by the user who stands on the board with both feet, wearing shoes. The peak-to-peak displacement to which the feet are exposed increases with the distance of the feet from the centre line of the vibrating board. Three positions marked 1, 2 and 3 are indicated on the vibrating board, corresponding to peak-to-peak displacements of 2, 4, and 6mm. The peak acceleration exerted by vibration exercise increases with higher frequencies and higher amplitudes.
15981016|NCT03029299|Device|FilmArray RP EZ|Patients in the intervention arm will be tested with the FilmArray RP EZ and the results of the test will be provided to the treating clinician
15981017|NCT03029286|Behavioral|Usual Care Arm|Health information provided by the American Cancer Society Website
15981018|NCT03029286|Behavioral|Personalized Web Intervention Arm|Women will be assigned to view a tailored website featuring their personalized risk information for breast cancer related to breast density and other factors.
15981019|NCT03029273|Drug|Cyclophosphamide and Fludarabine|Seven days prior to infusion of TCR-T cell, subjects receive cytoreductive chemotherapy with cyclophosphamide (250-500mg/m2/day) plus fludarabine (25mg/m2/day) for 3 days.
15981020|NCT03029273|Biological|Anti-NY-ESO-1 TCR transduced T cells|A single dose of Anti-NY-ESO-1 TCR transduced T cells (about 5×109) will be intravenously (i.v.) administered Additionally, following infusion of Anti-NY-ESO-1 TCR transduced T cells, IL-2 subcutaneous injections (500,000 IU/day) will be administered for 14 days concomitantly to each subject.
15981021|NCT03029260|Other|Neural mobilization - tension.|"Neural mobilization in tension consists of using combinations of joint movement known to maximize the tension and lengthening of peripheral nervous structures.
~The intervention will be delivered in one session only."
15981022|NCT03029260|Other|Neural mobilization - gliding|"Gliding neural mobilization consists of using combinations of joint movement known to maximize the movement of the peripheral nerves in relation to adjacent structures.
~The intervention will be delivered in one session only."
15981023|NCT03029247|Drug|Daprodustat|Daprodustat will be available as oral tablets at unit dose strength of 1, 2, 4, 6, 8 and 10 mg.
15981024|NCT03029247|Drug|Epoetin alfa|Epoetin alfa will be administered according to local labelling and clinical practice guidelines to keep Hgb in the target range (10.0-11.0 g/dL)
15981025|NCT03029234|Drug|Dexamethasone|20 mg intravenous (IV) or oral dexamethasone on days 1, 2, 8, 9, 15, 16, 22, and 23 in 28-day cycles.
15981026|NCT03029234|Drug|Carfilzomib|Infusion of IV carfilzomib on days 1, 2, 8, 9, 15 and 16 in each 28-day cycle.
15981027|NCT03029221|Other|PREP 8.0 curriculum developed by PREP|healthy marriage and relationship education
15981028|NCT03029221|Other|Within My Reach curriculum developed by PREP|healthy marriage and relationship education
15981029|NCT03029221|Other|Within Our Reach 8 Hours curriculum|healthy marriage and relationship education
15981033|NCT03029195|Device|Nasoalveolar molding therapy|Presurgical infant orthopedics
15981034|NCT03029182|Other|Walking+simulated-altitude|Participants will walk on a treadmill for up to 50 minutes at a 16% oxygen level (administered via exercise mask), which is similar in altitude to Flagstaff, AZ. The progression of exercise training will be based on a varying percents of heart rate reserve.
15981035|NCT03029182|Behavioral|Walking (control)|Participants will walk on a treadmill for up to 50 minutes.The progression of exercise training will be based on a varying percents of heart rate reserve.
15981036|NCT03029169|Drug|Propafenone i.v.|Treatment
15981037|NCT03029169|Drug|Amiodarone i.v.|Treatment
15981038|NCT03029156|Device|Aeroneb nebulizer|"The Aeroneb Nebulizer System is a portable medical device for single patient use that is intended to aerosolize physician-prescribed solutions for inhalation to patients on and off ventilation.
~The Aeroneb Adapter is an accessory specific to the Aeroneb Nebulizer. It facilitates intermittent and continuous nebulization and optional supply of supplemental oxygen to adult patients in hospital use environments via a mouthpiece or aerosol mask. The Aeroneb Nebulizer System and Adapter are FDA approved devices for nebulizing solutions including bronchodilators (albuterol and ipratropium)."
15981039|NCT03029156|Device|Small volume jet nebulizer|The bronchodilators will be administered via small volume jet nebulizer
15981040|NCT03029143|Drug|Vedolizumab IV|Vedolizumab intravenous infusion
15981041|NCT03029130|Device|Catheter extension|Foley transurethral catheter placed to allow continuous drainage of urine.
15981042|NCT03029117|Procedure|correction of rheumatic valve lesions|
15981043|NCT03029104|Combination Product|CXLO Corneal Strengthening Solution and UVA Illumination Device|CXLO Corneal Strengthening Solution
15981044|NCT03029091|Drug|Losartan Potassium|Losartan potassium
15981045|NCT03029078|Drug|fecal microbiota transplant|We will perform a fecal microbiota transplant for patients harboring XDR bacteria in their digestive tract
15981046|NCT03029052|Behavioral|Reconciliation|In addition to standard healthcare procedures, the pharmacist will analyze discharge prescriptions and proceed to medication reconciliation. A patient's counseling session will also be provided by the pharmacist. A reconciliation mail will be addressed to the PCP.
15981047|NCT03029039|Other|Blood samples|Blood samples will be collected at inclusion.
15981048|NCT03029026|Other|Baseline assessment|Baseline assessment will include clinical history, Quality of Life Questionnaire (EQ-5D/SF-12), a 6-minute-walk test, blood sampling for haematocrit, renal function, biomarkers (NT-pro-BNP and troponin), and biobanking (also for AL exclusions if scanning positive), a urine sample for biobanking (also for AL exclusions if scanning positive), as well as tests performed as the routine pre-operative work-up (clinical electrocardiogram, blood pressure to estimate global LV afterload, valvulo-arterial impedance).
15981126|NCT03028454|Dietary Supplement|Ginger Root|Capsules containing 250 mg of ginger root extract standardized to contain at least 5% gingerol compounds, as well as an additional 225 mg of regular ginger root.
15981049|NCT03029026|Procedure|Transthoracic echocardiography|"Patients will undergo a clinical transthoracic echocardiogram for the assessment of AS severity and diastolic function in line with the British Society of Echocardiography guidance. Simultaneous, optimised 2-chamber, 3-chamber and 4-chamber views will need to be recorded (over 3 cycles) for strain analysis.
~Severe AS will be defined using standard echocardiography guidelines in conjunction with MDT consensus."
15981050|NCT03029026|Procedure|99mTc-3,3-diphosphono-1,2-propanodicarboxylic acid scintigraphy|Scanning will use a hybrid SPECT-CT gamma camera after intravenous injection of 700 MBq of DPD (effective dose 4mSv). Acquisition technique: 5-minute (early) and then 3-hour (late) whole body planar scans, followed by SPECT-CT of the heart. Qualitative visual (Perugini) scoring of the cardiac uptake is performed from the 3-hour whole body planar images and the SPECT-CT images.
15981051|NCT03029026|Radiation|CT 3-5-minute post-contrast research sequences|Cardiac CT for ECV will use the dedicated cardiac CT scanner (Somatom FORCE; Siemens Medical Solutions, Germany). 3-5-minute post contrast research images will be taken at the end of the clinically indicated TAVR work-up CT.
15981052|NCT03029026|Procedure|Cardiac Magnetic Resonance|CMR will be performed using a 1.5-T Aera for standard late gadolinium enhancement, as well as T1 mapping and ECV.
15981053|NCT03029026|Procedure|Endomyocardial biopsy|Septal tissue specimens will be taken under direct vision by the surgical team using a 14-gauge coaxial needle system. Biopsies will be screened for amyloid by Congo red staining; if positive, tissue will be fully sub-typed (immunohistochemistry, mass spectrometry).
15981054|NCT03029026|Other|Follow-up assessment|1-year follow-up with clinical echocardiogram (for sAVR and TAVI patients) and/or telephone interview for all patients (if not carried out in person at the time of the echocardiogram). This will include a follow up Quality of Life Questionnaire as per baseline. If attending clinic or echocardiogram a 6-minute-walk test will also be performed.
15981055|NCT03029013|Drug|Apatinib|Apatinib， 250 mg qd，po，after 7 days , paclitaxel (135-175 mg/m2) and platinum two drug standard chemotherapy, 21 days as a treatment cycle，during the chemotherapy of 7-21 days continue to offer the Apatinib. without disease progress, after 4 chemotherapy cycles, patients continue to accept the Apatinib maintenance treatment.
15981056|NCT03029000|Drug|Tbo-filgrastim|solution for subcutaneous injection
15981057|NCT03028987|Biological|Fluzone®|Fluzone® Quadrivalent (IIV4; inactivated influenza virus vaccine)
15981058|NCT03028987|Biological|FluMist®|FluMist® Intranasal Spray (quadrivalent, live, attenuated influenza vaccine)
15981059|NCT03028974|Biological|Fluzone®|Fluzone® Quadrivalent: Quadrivalent influenza virus vaccine
15981060|NCT03028974|Biological|FluMist®|FluMist® Quadrivalent: Quadrivalent influenza virus vaccine live, intranasal spray
15981061|NCT03028961|Other|Stanford Letter|Receive and complete the Stanford Letter
15981062|NCT03028961|Other|Interview|Undergo semi-structured, research staff-led interview
15981063|NCT03028961|Other|Questionnaire Administration|Ancillary studies
15981064|NCT03028961|Other|CA Advance Health Care Directive Form|Receive and complete the CA Advance Health Care Directive Form
15981065|NCT03028948|Other|Internet-Based Intervention|Access ITW
15981066|NCT03028948|Other|Questionnaire Administration|Ancillary studies
15981067|NCT03028948|Other|Survey Administration|Ancillary studies
15981068|NCT03028935|Behavioral|Exercise Intervention|Undergo instructor-led exercise program
15981069|NCT03028935|Behavioral|Nutritional Intervention|Undergo instructor-led nutritional education program
15981070|NCT03028922|Device|creos xenogain|GBR procedure will be performed using creors xenogain bone graft substitute in patients that need horizontal bone augmentation prior to implant placement. The defect should be located in the pre-molar and molar region of the mandible
15981071|NCT03028909|Drug|Oseltamivir|Standard of care for influenza caused by Type A strains
15981072|NCT03028909|Drug|MEDI8852|MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) administered via infusion.
15981073|NCT03028909|Drug|Placebo|Salt-water solution containing no active ingredients.
15981074|NCT03028896|Procedure|90° rotational technique|the LMA FlexibleTM was rotated counter-clockwise through 90°
15981075|NCT03028883|Other|Dose adjustments|Do higher doses of buprenorphine result in a higher rate of neonatal abstinence syndrome as compared to lower doses of buprenorphine
15981076|NCT03028870|Drug|V120083|Capsules
15981077|NCT03028870|Drug|Naproxen|Capsules
15981078|NCT03028870|Drug|Placebo|Capsules to match V120083 and/or naproxen
15981079|NCT03028857|Drug|Choline|Mothers are instructed to take the capsules twice a day, five 450 mg phosphatidylcholine capsules at breakfast and five phosphatidylcholine 450 mg capsules at dinner.
15981080|NCT03028857|Dietary Supplement|Placebo|Mothers are instructed to take the capsules twice a day, five placebo corn oil capsules at breakfast and five placebo corn oil capsules at dinner.
15981081|NCT03028844|Other|Music therapy|The musical intervention will be played for ten minutes prior to venepuncture
15981082|NCT03028831|Dietary Supplement|70g of fully digestible starch amylopectin corn starch|Fully digestible amylopectin corn starch
15981083|NCT03028831|Dietary Supplement|Resistant starch|70g high-amylose maize starch
15981084|NCT03028805|Other|Automatic inclusion of COPD orders in admission orders|Use of real-time data to identify a population of patients with COPD and prompt improved adherence to evidence-based guidelines through the automatic inclusion of a COPD order set in the admission orders.
15981085|NCT03028805|Other|Dynamic, end-user order set design|Use of a dynamic order set that has been end-user tested prior to launch rather than designed centrally by a committee to test use of order set components.
15981086|NCT03028792|Behavioral|Attention Modification Program|"Each trial begins with a fixation cross at the center of the computer screen for 500 ms. The cross is then replaced by a face pair presented in the center of the screen. The face pair disappears and a probe (letter E or F) appears immediately in the location of one of the two previous stimuli. Youth will be instructed to decide whether the letter is an E or an F and press the corresponding mouse button. This paradigm has been modified to facilitate an attention bias away from threat material. In this case, the probe always replaces the neutral stimuli. Thus, although there will be no specific instruction to direct attention away from the threat stimuli, on all trials, the position of the neutral stimulus will indicate the position of the probe."
15981127|NCT03028454|Dietary Supplement|Placebo|Capsules containing rice flour powder.
15981087|NCT03028792|Behavioral|Attention Control Condition|"Each trial begins with a fixation cross presented in the center of the computer screen. The cross is then replaced by a face pair presented in the center of the screen. The face pair disappears and a probe (letter E or F) appears immediately in the location of one of the two previous stimuli. Youth will be instructed to decide whether the letter is an E or an F and press the corresponding mouse button. This paradigm is not intended to facilitate an attention bias away from threat material. In this case, the probe randomly replaces the threat or neutral stimulus."
15981088|NCT03028779|Procedure|Fast-track Total Hip and knee arthroplasty|To be able to do a total knee or hip arthroplasty and return the patient home in less then 24 hours
15981089|NCT03028766|Drug|AZD1775|AZD1775 is a potent, selective small molecule inhibitor of WEE1
15981090|NCT03028766|Drug|Cisplatin|Chemotherapy drug
15981091|NCT03028766|Radiation|Radiotherapy|Intensity Modulated Radiotherapy
15981092|NCT03028753|Device|Bladder scan post void residual|After voiding on the commode, all subjects will have a post void residual measured by bladder scanner
15981093|NCT03028753|Procedure|Straight catheter post void residual|After voiding on the commode and having a post void residual measured by bladder scanner, all subjects will have a post void residual measured by straight catheter performed with usual sterile technique.
15981094|NCT03028753|Procedure|Back fill voiding trial|Prior to catheter removal, all subjects will undergo a back fill voiding trial. The bag of the foley catheter will be removed and the subjects bladder will be filled with 300cc of normal saline (or as much as they can tolerate). The foley catheter will then be removed and the subject will be asked to void on the commode. The voided volume will be measured.
15981095|NCT03028740|Drug|Cenicriviroc|1 tablet QD
15981096|NCT03028740|Drug|Placebo|1 tablet QD
15981097|NCT03028727|Procedure|Ultrasonic Scaling and root planing|Procedure of scaling and root planing at day 0 and at 1 week
15981098|NCT03028727|Procedure|980 nm diode laser irradiation|Procedure of scaling and root planing and application of 980 nm diode laser at day 0 and at 1 week
15981099|NCT03028714|Behavioral|Technology-based nutrition education|All participants will undertake anthropometric measurements and assessments of blood pressure and blood glucose. They will be also asked to complete online questionnaires with regards to nutrition and physical activity. Participants in the intervention group will receive additional access to a website, providing information about nutrition topics including alcohol and physical activity. Through the website participants will be asked to play online quiz-games related to the nutrition topics. Each play will include game elements such as time, point collection and graphics. Participants will be asked to play the games as much as they want to improve their scores and to use the website as a reference tool.
15981100|NCT03028701|Drug|Formoterol/Budesonide 12/400 mcg Discair|Formoterol/Budesonide 12/400 mcg Inhalation Powder (1 puff) once daily via Discair®
15981101|NCT03028688|Device|High flow nasal cannula oxygen|Participants will receive high flow nasal cannula oxygen delivery during anesthesia. Participants will also have transcutaneous PCO2 measurements performed using a cutaneous electrode.
15981102|NCT03028675|Other|MRI Scan|MRI scans will consist of a 1-hour brain scan for both patients and controls.
15981103|NCT03028662|Behavioral|Retrieval-Extinction Learning|The intervention consists of the accomplishment of the task of approach-avoidance of alcohol during 4 days of training. Subjects are instructed to respond with an approach movement (pulling a lever) to neutral images and to respond with avoidance movement (pushing the lever) to images of alcohol.
15981104|NCT03028649|Dietary Supplement|β-hydroxy-β-methylbutyrate and a placebo supplementation|
15981105|NCT03028623|Procedure|Salpingectomy|Bilateral salpingectomy will be performed instead of standard tubal ligation as sterilization during cesarean section.
15981106|NCT03028623|Procedure|Tubal ligation|Standard tubal ligation by either Parkland or Pomeroy technique will be performed at cesarean section
15981107|NCT03028610|Device|radiofrequency generator|
15981108|NCT03028597|Behavioral|Intervention Values Affirmation|Participants are asked to circle the two or three values that are MOST important to them. Next, participants are asked to think about times when the values chosen might be important to THEMSELVES and then write a few sentences to describe when and why they might be important.
15981109|NCT03028597|Behavioral|Control Values Affirmation|Participants are asked to circle the two or three items that are LEAST important to them. Next, participants are asked to think about times when the values chosen might be important to SOMEONE ELSE and then write a few sentences to describe when and why they might be important.
15981110|NCT03028584|Behavioral|Survey|Subjects (cancer patients and clinicians) will complete up to 2 surveys.
15981111|NCT03028571|Drug|Trimethaphan|Trimethaphan 4 mg/min IV will be given as a pharmacological tool to study the role of the autonomic nervous system on the regulation of endogenous glucose production by the liver.
15981112|NCT03028571|Other|Saline|IV saline at a rate of 48 mL/hr, will be given during the insulin clamp to resemble the volume infused in the intact day
15981113|NCT03028545|Behavioral|Collection of the individual narrative, semi-directed interviews|Visit one : individual interview Individual narrative Passing Psychometric Measurement Scales of Recovery: Score at Warwick and Wellness Scale Andreasen scale score Visit two Focus group
15981114|NCT03028532|Drug|Clomid|Participants will self-administer Clomid (50mg oral tablet) once daily for 30 consecutive days
15981115|NCT03028519|Drug|Vitamin D3|Vitamin D3
15981116|NCT03028506|Other|Carbohydrate intake|By calculating carbohydrate amounts at meals and snacks, as well as classifying meals and snacks as high fat, the investigators will examine the correlation to higher preprandial blood glucose values and large for gestational age infants.
15981117|NCT03028493|Behavioral|Original SAFE Intervention|A CDC recommended, evidence-based falls prevention intervention.
15981118|NCT03028493|Behavioral|Adapted SAFE Intervention|An adapted version of the SAFE intervention meant to target older adults with low vision.
15981120|NCT03028467|Drug|GSK3196165 Dose 1|GSK3196165 is supplied as liquid and will be administered as SC injection.
15981121|NCT03028467|Drug|GSK3196165 Dose 2|GSK3196165 is supplied as liquid and will be administered as SC injection.
15981122|NCT03028467|Drug|GSK3196165 Dose 3|GSK3196165 is supplied as liquid and will be administered as SC injection.
15981130|NCT03028428|Biological|Placenta Derived Mesenchymal Stem Cell|1ml 1*10^7 Placenta Derived Mesenchymal Stem Cell administered into the knee joint once
15981131|NCT03028428|Drug|Sodium Hyaluronate|Sodium hyaluronate administered into the knee joint once
15981132|NCT03028415|Device|AMPLEX|A bone graft substitute
15981133|NCT03028415|Procedure|Autogenous Bone Graft (ABG)|Control material administered by surgical implant
15981134|NCT03028402|Procedure|C5-C6 arthrodesis|A standard Smith Robinson anterior medial approach to the cervical spine. Vertebral endplates will be prepared by removing the cartilage endplate. Tricortical anterior iliac crest autografts will be harvested with a low-speed oscillating saw. Allografts will be fresh-frozen, vacuum-sealed, nonradiated tricortical grafts. All grafts will be fashioned in a typical Smith-Robinson formation. The motion segment will be distracted approximately 2-mm beyond the graft height before the insertion of each graft. Fusion plate will be contoured to cervical lordosis. Cervical plates will be positioned using surgical midline markers. All rigid anterior plate fixations will be performed using titanium anterior fixed-angle screw systems.
15981135|NCT03028389|Procedure|limb remote ischemic preconditioning(LRIP)|LRIP consisted of three cycles of left upper limb ischemia induced by inflating a blood pressure cuff on the left upper arm to 200mmHg, with an intervening 5 minutes of reperfusion, during which time the cuff was deflated.
15981136|NCT03028376|Other|Blood sampling|Blood sampling from peripheral venous catheter routinely inserted in trauma patients during transportation
15981137|NCT03028363|Drug|Olumacostat Glasaretil Gel, 5.0%|Gel containing Olumacostat Glasaretil
15981138|NCT03028363|Other|Olumacostat Glasaretil Gel, Vehicle|Vehicle (placebo) gel
15981139|NCT03028350|Drug|Ifetroban Oral Capsule|Subjects will be treated with oral ifetroban daily for 8 weeks
15981140|NCT03028350|Drug|Placebo Oral Capsule|Subjects will be treated with oral placebo daily for 8 weeks
15981141|NCT03028337|Radiation|Spine Radiosurgery|"Spine Radiosurgery - 1 Dose: For single fraction and multifraction arms, 0.01 cc of the cord allowed to receive 10 Gy and 14 Gy, respectively while 0.01 cc of the cauda equina allowed to receive 14 Gy and 18 Gy, respectively.
~Spine Radiosurgery - 3 Doses (3 days): The dose for the multifraction arm is 27 Gy in 3 fractions (9 Gy per fraction)."
15981142|NCT03028337|Behavioral|Questionnaires|"Participants complete 3 questionnaires about any pain they may be having, quality-of-life, and any other symptoms. It should take about 10 minutes to complete these questionnaires.
~Questionnaires completed at Baseline and at Months 3,6,9,12,18, and 24 and then every 6 months after that during follow up."
15981143|NCT03028324|Device|Transcranial Magnetic Stimulation (TMS)|Non-invasive brain stimulation, high frequency repetitive TMS delivered in 10 sessions over a 2-week period.
15981144|NCT03028311|Procedure|Angiography|Undergo angiography
15981145|NCT03028311|Procedure|Computed Tomography|Undergo SPECT-CT
15981146|NCT03028311|Procedure|Planar Imaging|Undergo planar imaging
15981147|NCT03028311|Radiation|Radioembolization|Undergo radioembolization
15981148|NCT03028311|Procedure|Single Photon Emission Computed Tomography|Undergo SPECT-CT
15981149|NCT03028311|Radiation|Technetium Tc-99m Albumin Aggregated|Given via arterial catheter
15981150|NCT03028311|Other|Yttrium Y 90 Resin Microspheres|Given via arterial catheter
15981151|NCT03028298|Drug|Low dose sildenafil citrate|
15981152|NCT03028298|Drug|High dose sildenafil citrate|
15981153|NCT03028285|Drug|arginine sodium succinate|Healthy volunteers will receive the experimental drug (arginine sodium succinate 1.4% solution; Unifusol) intravenously at 3 different combinations of dose and infusion rate under the close monitoring of vital signs and other safety parameters.
15981154|NCT03028272|Other|Skye Barrier|Substrate derived from amniotic tissue that is FDA-approved for human implantation
15981155|NCT03028272|Other|Fascia|Autologous donor substrate. Examples include tragal cartilage, perichondrium, temporalis fascia, and temporoparietal fascia
15981156|NCT03028259|Other|lab results|Comparison of lab results
15981157|NCT03028246|Device|ExAblate 4000 System|Focused ultrasound
15981158|NCT03028233|Behavioral|Healthy Lifestyle|A Community Health Worker coaches families regarding healthy eating, physical activity, and obesity prevention, and promotes the use of existing built environment resources.
15981159|NCT03028233|Behavioral|Positive Parenting|A Community Health Worker coaches parents on improving positive parenting skills and promotes the use of relevant community resources.
15981160|NCT03028220|Device|Dexcom G5 Continuous Glucose Monitor|Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values
15981161|NCT03028220|Device|Abbott Freestyle Libre|Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data
15981162|NCT03028207|Procedure|Medical tests|During Visit 1, subjects will go through medical tests including spirometry, bronchodilation test, pulse oximetry, cooximetry, and bioimpedance. Additional tests will be performed at up to 9 centers such as pulmonary diffusion test, 6 minute walk test, CT during the same visit.
15981163|NCT03028207|Other|Questionnaire|During Visit 1, subjects will be given an Electronic Case Report Form (eCRF) with a series of questionnaire such as Health Related Quality of Life (HRQoL) CAT questionnaire, HADS anxiety scale, YPAS physical activity questionnaire, ECSC respiratory symptoms questionnaire, occupational exposure related questionnaire, MMSE questionnaire, Fagerstrom test, Prochaska test.
15981164|NCT03028194|Procedure|Curettage|Postpartum uterine curettage with a sharp curette # 14 or #16, immediately after delivery of the placenta.
15981165|NCT03028194|Procedure|Placebo|No procedure after delivery of the placenta
15981166|NCT03028168|Other|Yôga|Intervention observing respiratory frequency (RF) of 15- 20 respiratory cycles per minute (rcpm). A standardized 7-minute final relaxation .
15981167|NCT03028168|Other|Breathing technique|Intervention uses diaphragmatic breathing, observing slow respiratory frequency, between 5-8 rcpm. A standardized 7-minute final relaxation.
15981168|NCT03028168|Other|Control group|Patients will be oriented to keep their pharmacological routine and daily activities, with no structured exercises. They will have to return to the hospital for post-testing after 8 weeks from randomization
15981169|NCT03028155|Drug|Oxaliplatin: BSA-based HIPEC|oxaliplatin: 460 mg/m2 volume: dependent on the capacity of the peritoneal cavity of the patient
15981170|NCT03028155|Drug|Oxaliplatin: Concentration-based HIPEC|oxaliplatin: 230 mg/L
15981174|NCT03028129|Drug|Isoniazid 900 milligrams|Oral tablet, with the isoniazid 900mg, given two weekly. The administration will be supervised.
15981175|NCT03028129|Drug|Placebo|Oral tablet, without the active ingredient, similar in size, weight, color, taste and odor.
15981176|NCT03028116|Biological|influenza vaccine|"A allantoic split inactivated seasonal influenza vaccine has been prepared on eggs and is made from inactivated parts of the following influenza virus strains:
~NIBRG-121xp (A/California/7/2009 (H1N1)v and А/PR/8/34 (H1N1)), NYMC X-217 (A/Victoria/361/2011(H3N2) and А/PR/8/34 (H1N1)), NYMC BX-49 (B/Texas/06/2011 (Yamagata lineage) - like High Yield Reassortant (1:1:6) With B/Lee/40 NP, B/Panama/45/90 NS genes)."
15981177|NCT03028116|Biological|Placebo|water for injection
15981178|NCT03028103|Drug|Tazemetostat|Tazemetostat is a selective oral small molecule inhibitor of EZH2
15981179|NCT03028103|Drug|Fluconazole|200mg will be orally administered QD for 4 days in order to determine CYP3A4 inhibition when administered concomitantly with tazemetostat
15981180|NCT03028103|Drug|Omeprazole|Using omeprazole as a probe substrate, 20mg will be orally administered for a total of 5 days in order to determine the potential of tazemetostat to inhibit or induce CYP2C19. Omeprazole is also being used to determine the effect of increased gastric pH on metabolism of tazemetostat.
15981181|NCT03028103|Drug|Repaglinide|Using repaglinide as a probe substrate, 25mg will be orally administered for a total of 2 days in order to determine the potential of tazemetostat to inhibit or induce CYP2C8.
15981182|NCT03028090|Device|SHERLOCK 3CG™ Tip Confirmation System with MODUS Software|The SHERLOCK 3CG™ Tip Confirmation System (TCS) is a fully-integrated magnetic tracking and ECG-based PICC tip confirmation technology. It was cleared by the FDA on March 19, 2012 and is indicated for use as an alternative to chest x-ray and fluoroscopy for PICC tip placement confirmation in adult patients. In order to further develop the SHERLOCK 3CG™ platform and simplify the PICC placement for the clinician, Bard Access Systems, Inc. is developing MODUS, a software package.
15981183|NCT03028077|Dietary Supplement|GS-3K8|GS-3K8 (ultrafiltered red ginseng extract) 1 g/day
15981184|NCT03028077|Dietary Supplement|GINst15|GINst15 (hydrolyzed ginseng extract) 1 g/day
15981185|NCT03028077|Dietary Supplement|Placebo|Placebo 1 g/day
15981186|NCT03028064|Other|blood taking|in this cohort study, we will take blood to examine the platelet function
15981187|NCT03028038|Drug|Platelet Rich Plasma|"Platelet Rich Plasma (PRP) will be injected beneath the buccal periosteal of the first molar and premolar in one mouth side with a split-mouth design before the beginning of Rapid Maxillary Expansion and after 7 days of it.
~High resolution cone beam computed tomography (CBCT) will be taken before treatment and after 3 months when the Hyrax is removed."
15981188|NCT03028038|Drug|No Platelet Rich Plasma|"No Platelet Rich Plasma (PRP) will be injected in the other mouth side with a split-mouth design during Rapid Maxillary Expansion.
~High resolution cone beam computed tomography (CBCT) will be taken before treatment and after 3 months when the Hyrax is removed."
15981189|NCT03028025|Device|StatSeal|Patients randomly assigned to the experimental group will have a Statseal Advance (SSA) disc applied after withdrawing the radial sheath 2-4 cm. A Tegaderm dressing will be applied to secure the disc position. The TR band will be applied over the SSA disc with the center of the balloon (the green dot) over the center of the SSA disc. The TR band will be inflated with 8cc of air (which is typically occlusive pressure), and the sheath removed. No deflation will occur immediately. After 20 minutes of pressure, 3 cc of air will be removed from the TR band. After an additional 20 minutes (40 minutes after procedure), the TR band will be completely deflated, and the TR band left in place. After an additional 20 minutes (60 minutes after procedure) the TR band will be removed.
15981190|NCT03028025|Device|TR Band|Patients randomly assigned to the control group will have a TR band applied over the arteriotomy site and inflated with 15-18ml of air. After aspirating and clearing the contents of the sheath, the radial sheath will be removed. The TR band will be deflated until bleeding occurs, and 2 ml of air will be reintroduced to provide hemostasis. Patent hemostasis will be documented with plethysmography and oximetry as described below within 5 minutes after band application and removal, and within 30 min of discharge or after 24 hours. The TR band will be left inflated and in place for 2 hours following the procedure for all patients (regardless of diagnostic or PCI procedure), after which deflation attempts will commence.
15981191|NCT03028012|Drug|Ketorolac|Participants may be randomized to receive Ketorolac for their TPI. This randomized study will compare the efficacy of the three substances used in TPIs.
15981192|NCT03028012|Drug|Lidocaine|Participants may be randomized to receive Lidocaine for their TPI. This randomized study will compare the efficacy of the three substances used in TPIs.
15981193|NCT03028012|Drug|Dexamethasone|Participants may be randomized to receive Dexamethasone for their TPI. This randomized study will compare the efficacy of the three substances used in TPIs.
15981194|NCT03027999|Other|tight nursing follow-up|"In addition to the usual follow-up by their rheumatologist tight nursing follow-up patients will benefit of
~a training session to self-assess their RA: Self-assessment of the number of painful and swollen joints, of pain and disease activity (global assessment by the patient) (self-DAS). During this session, a scheduled dosage of ESR and CRP levels will be given to the patient.
~A monthly call by a nurse who inquires about the results of the patient's self-assessment. As soon as she suspects a relapse of RA, she plans a consultation to confirm or not the relapse. For this purpose, she calculates the DAS28 taking into account the results of the biological test, the articular count and the disease activity. Clinical relapse is documented by a DAS28-CRP > 2.7"
15981195|NCT03027986|Behavioral|postural rehabilitation program|This program is based on sensory-motor control
15981196|NCT03027973|Drug|UPA|Experimental drug
15981197|NCT03027973|Drug|TEA|Active comparator
15981198|NCT03027973|Drug|Placebo (for UPA)|Sugar pill manufactured to mimic UPA 5 mg
15981199|NCT03027973|Drug|Placebo (for TEA)|Sugar pill manufactured to mimic TEA 500mg
15981200|NCT03027960|Drug|Empagliflozin|10mg empagliflozin for a 2-week period
15981201|NCT03027960|Drug|Placebo Oral Capsule|10 mg placebo for a 2-week period
15981202|NCT03027947|Device|Spinal cord stimulator|Spinal cord stimulator leads (2-3 leads) will be placed in the lumbar epidural space of lower limb amputees to determine if the patient experiences any pain reduction from spinal cord stimulation.
15981203|NCT03027934|Drug|Ticagrelor|Ticagrelor, 90mg twice daily
15981204|NCT03027934|Drug|Prasugrel|Prasurgrel, 10mg once daily
15981205|NCT03027921|Other|elastography|
15981209|NCT03027895|Device|Double pigtail plastic stent (DPPS)|Endoscopic Ultrasound-guided Drainage of WON with DPPS
15981210|NCT03027882|Other|No Intervention|This is a reliability/validity study of a functional clinical test. There is no intervention
15981211|NCT03027869|Device|transcranial direct current stimulation|15 minute anodal stimulation 1.5mA
15981212|NCT03027856|Device|Magmaris|Implantation of a sirolimus eluting bioresorbable magnesium stent
15981213|NCT03027843|Drug|Growth Hormone|in GH group, patients have weekly injections of GH dose 14 iu, until the day of hCG.
15981214|NCT03027830|Device|iFR pressure-wire|The instantaneous wave-free ratio (iFR) as an adenosine-independent index of coronary stenosis severity, calculated as the ratio between the distal trans-stenotic pressure and the proximal coronary pressure during a specific diastolic wave-free period
15981215|NCT03027830|Device|Conventional|Other diagnostic devices (including FFR and angiography)
15981216|NCT03027817|Procedure|Prone Positioning|Noninvasive cardiac output monitoring parameters were recorded before and after prone positioning.
15981217|NCT03027804|Procedure|Ross Operation|Replacement of the aortic valve by means of pulmonary artery autograft
15981218|NCT03027791|Behavioral|Virtual Reality|Participation in Virtual Reality experiences focused on a) education about the effects of high sodium foods on coronary arteries, blood pressure, the kidneys, and the cerebral vasculature, and b) stress management.
15981219|NCT03027791|Behavioral|Group Sessions|12 weekly group sessions that will provide education on topics related to hypertension, dietary sodium, physical activity and stress.
15981220|NCT03027778|Other|Exercise|Intradialytic pedalling exercise during regular dialysis sessions (3x per week) for 4 months
15981221|NCT03027752|Procedure|Operation carotid endarterectomy with plastic of xenopericardial patch|Under local anesthesia Sol.Novocaini 0.25%, wires or endotracheal anesthesia using the standard access the bifurcation of the common carotid artery, internal carotid artery, isolated on identical distance external carotid artery. Common carotid artery cut then performed a longitudinal arteriotomy on the front of the anterior surface of the internal carotid artery. Under the visual control performs a sequence of endarterectomy of the internal carotid artery. Plastic arteriotomy performed patche of ksenoperikardial (Kemperiplas-Neo) treated with epoxy compounds.
15981222|NCT03027752|Procedure|New method of operation сarotid endarterectomy with autoarterial remodeling of bifurcation CCA|Under local anesthesia Sol.Novocaini 0.25%, or endotracheal anesthesia using the standard access the bifurcation of the common carotid artery, internal carotid artery, isolated on identical distance external carotid artery. Carotid glomus separated and moves downward and backward bifurcation of the common carotid artery. External carotid artery is cut off at an angle of 45º from the mouth with a portion of the common carotid artery, then performed a longitudinal arteriotomy on the front of the medial surface of the internal carotid and posterior-lateral surface of the external carotid artery. Under the visual control performs a sequence of endarterectomy of the internal and external carotid arteries. The final recovery of the arteries is performed by crosslinking of their walls with each other in a side by side type between the internal and external carotid arteries 6/0 Polypropylene thread with two needles.
15981223|NCT03027739|Biological|CART-19|CART-19 cells treated
15981224|NCT03027726|Behavioral|lifestyle and psycho-educational program|The family-based healthy lifestyle education and psychological education program will be followed once every two weeks (11 sessions over 22 weeks) for 90 minutes (45 minutes in the healthy lifestyle education program and 45 minutes in the psycho-educational intervention). The sessions of the healthy lifestyle education and psycho-educational interventions will be developed simultaneously and delivered to both parents (or caregivers) and children, separately. The family-based healthy lifestyle education program will be conducted by experienced nutritionists and the psycho-educational program by experienced psychologists in behavior changes
15981225|NCT03027726|Other|Exercise plus lifestyle and psycho-educational program|The intervention group will attend the same lifestyle education and psycho-educational program plus the exercise program. The exercise group will do exercise 3 days/week, 90 minutes per session, over a 22-week period. The program will be offered to the families five days per week to choose a total of three days/week. Sessions will be designed and supervised by exercise specialists. The duration of training sessions will be 90 minutes of exercise, including warm-up, moderate to vigorous aerobic activities, and strength exercises
15981226|NCT03027713|Procedure|weaning protocol|The patients were allocated in the NAVA weaning protocol group o in the PSV weaning protocol group
15981227|NCT03027700|Device|MRI|MRI scan performed on 1.5T Philips Ingenia MRI scanner.
15981228|NCT03027687|Device|tDCS|tDCS is an electrical brain stimulation method
15981229|NCT03027674|Drug|10% nifedipine cream|Topical treatment for Raynaud
15981230|NCT03027674|Drug|5% sildenafil cream|Topical treatment for Raynaud
15981231|NCT03027661|Drug|Bupivacaine|Inject 10 mL of 0.5% bupivacaine into cervical stroma
15981232|NCT03027661|Drug|0.9% Sodium Chloride|Inject 10 mL of 0.9% NaCl into cervical stroma
15981233|NCT03027648|Procedure|Placement of levonorgestrel-releasing intrauterine system|All the patients accepted treatment of levonorgestrel-releasing intrauterine system
15981234|NCT03027635|Device|PleurX, peritoneal tunnelated catheter|A permanent catheter
15981235|NCT03027635|Device|Large Volume Paracentesis|Short time drainage
15981236|NCT03027635|Drug|Ciprofloxacin 500Mg Tablet|SBP prophylaxis
15981237|NCT03027622|Behavioral|quality of life in the patients with mild pericoronitis|active surviallence by OHIP-14 TR after treatment
15981238|NCT03027609|Drug|AR-105|monoclonal antibody
15981239|NCT03027609|Drug|placebo|matching placebo
15981240|NCT03027596|Procedure|Remote ischemic conditioning|
15981241|NCT03027583|Dietary Supplement|Probiotic|6 weeks daily oral intake of a probiotic strain.
15981242|NCT03027583|Dietary Supplement|Placebo|6 weeks daily oral intake of placebo.
15981243|NCT03027570|Behavioral|Control|Five-month interdisciplinary program, including: twice a week one-hour group exercise activity sessions, 3-5 group meetings with a dietician, 12-13 parent sessions with a social worker, and a healthy cooking workshop, each child will take part in individual sessions including: two appointments with a pediatrician, three sessions with a dietician and two sessions with a physical therapist serving as a consultant for physical activity.
15981354|NCT03026556|Drug|Dabigatran vs. Rivaroxaban|observed for 6 years
15981355|NCT03026556|Drug|Dabigatran vs. Apixaban|Observed for 6 years
15981244|NCT03027570|Behavioral|Exergame activity_EXG|"In addition to the treatment given to the control group (as described above), the EXG group will obtain home access to the app Just Dance Now and part of a weekly exercise session will include a group activity with the app."
15981245|NCT03027570|Other|Application activity|"The application - Just Dance Now will be downloaded to the cellular phone of the child or parent. Exercise using the app will be used by cell phone connection to the child's home computer and as part of exercise group activity."
15981246|NCT03027557|Drug|Cinacalcet 30 mg Tablet|Participants in one arm will receive 30 mg cinacalcet each day.
15981247|NCT03027557|Drug|Denosumab Inj 60 mg/ml|Participants in two arms will receive 60 mg Denosumab biannually.
15981248|NCT03027557|Other|Placebo tablets|Participants in two arms will receive one placebo-tablet each day.
15981249|NCT03027557|Other|Saline Injection (Placebo)|Participants in one arm will receive saline injections as placebo for denosumab.
15981250|NCT03027544|Radiation|tomotherapy|"Tomotherapy: The regular fraction modes were as follows: a. lesions≥3 cm:52Gy/4Gy/13f or 52.5Gy/3.5Gy/15f; b. lesions<2cm:36Gy/12Gy/3f or 24Gy/24Gy/1f; for lesions located in function areas, it would be adjusted to 40Gy/8Gy/5f; c. lesions 2-3cm: 40-48Gy/8-10Gy/6-4f; d. lesions located in brainstem:50-60Gy/2.5-3Gy/20f; 3. multiple lesions with large lesion: whole brain radiation (WBRT) with 40Gy/2Gy/20f and concurrent boost of 60Gy/3Gy/20f of the lesions.
~TMZ is used if necessary: concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/ m2*5d, q28d, up to 6cycles."
15981251|NCT03027531|Behavioral|eKISS: electronic KIOSK for Safer-Sex|An interactive computer-based intervention for safer-sex which provides individualized feedback about protective and risky sexual behaviors; offers instructive video modules for safe-sex; elicits change behavior and identification of behavior change goal using elements of motivational interviewing.
15981252|NCT03027518|Other|WILD 5 Wellness|Participants will be asked to voluntarily engage in integrated, prescriptive, and trackable wellness interventions combining five wellness elements including exercise, mindfulness, sleep, social connectedness, and nutrition.
15981253|NCT03027505|Drug|Ready to Use Therapeutic Food (RUTF)|"MUAC used as the primary admission and exit criteria for children with MUAC <125mm and no medical complication.
~Single treatment of RUTF for severe and moderate malnourished children and gradual reduction of doses according to the MUAC and the weight of the child during treatment. MUAC split into 3 categories:
~MUAC <115 mm: 175 kcal /kg/day
~115 <MUAC <120mm: 125kcal/kg/day
~120 <MUAC <125mm: 75kcal/kg/day"
15981254|NCT03027492|Other|Gluten free diet|The investigators will evaluate the modification of gynaecological disorder after a gluten (wheat)-free diet.
15981255|NCT03027479|Other|Samples|Blood samples, muscle biopsy, adipose tissue samples and ovarian cancer tumor sample
15981256|NCT03027466|Behavioral|Self-affirmation induction|Participants will be randomly assigned to one of 4 conditions as part of a 2 (Integrated affirmation: Affirmation texts present versus absent) X 2 (Baseline affirmation: questionnaire present versus absent) design (these affirmations are described below). Those in the control condition will receive no changes to the app (standard of care control condition). Booster affirmation: Participants will receive an integrated affirmation every time they spontaneously report experiencing a craving. These will show up in a screen that shows Tips. We will be able to assess how many times participants reported experiencing a craving and thus saw a booster message.
15981257|NCT03027414|Drug|Transcranial Magnetic Stimulatin Sham|TMS device is used to determine the effect of non-invasive brain stimulation on anxiety and anxiety-cognition interactions in healthy subjects.
15981258|NCT03027414|Device|Transcranial Magnetic Stimulation|TMS device is used to determine the effect of non-invasive brain stimulation on anxiety and anxiety-cognition interactions in healthy subjects.
15981260|NCT03027375|Drug|Qishen Granules|The QSG are manufactured by Beijing tcmages Pharmaceutical Co., Ltd. (Beijing, China), a company that has obtained Chinese Good Manufacturing Practice for Pharmaceutical Products certification. All the ingredients have been approved by the Chinese Ministry of Food and Drug Safety. 13.6 grams (dry weight) of granules consist of six herbs: Astragalus membranaceus (Fisch.) Bge. var. Mongolicus (Bge.) Hsiao (6g), Salvia miltiorrhiza Bge. (1.5g), Lonicera japonica Thunb. (2g), Scrophularia ningpoensis Hemsl. (2g), Aconitum carmichaeli Debx. (0.9g), and Glycyrrhiza uralensis Fisch. (1.2g).
15981261|NCT03027375|Drug|Placebo|The placebo is manufactured by Beijing tcmages Pharmaceutical Co., Ltd. (Beijing, China) as well, following the Specification for processing Chinese medicine in Beijing. The placebo granules are similar in appearance, taste, and scent to the Qishen granules.
15981262|NCT03027362|Other|Cognitive behavioral therapy (CBT) and medication|Sixteen sessions over 14 weeks.
15981263|NCT03027362|Other|Psychoeducation and medication|
15981264|NCT03027349|Other|No intervention are provided|
15981265|NCT03027336|Dietary Supplement|Coleosoma|patients will take one tablet of 500mg daily for 12 weeks. No dose titration is foreseen.
15981266|NCT03027336|Dietary Supplement|Placebo|patients will take one tablet daily for 12 weeks.
15981267|NCT03027323|Device|AxoTrack System|The AxoTrack system is a novel ultrasound guidance system intended to facilitate central venous cannulation (CVC) by a single operator as well as to reduce complications and time associated with CVC. The AxoTrack has a small ultrasound scan head which facilitates imaging of the subclavian vein.
15981268|NCT03027284|Drug|Merestinib|Administered orally
15981269|NCT03027284|Drug|Cisplatin|Administered IV
15981270|NCT03027284|Drug|Gemcitabine|Administered IV
15981271|NCT03027258|Other|mHealth|"HBI participants who consent will be enrolled in this study and will have data collected from their community screening stored in a secure, web-based database. The stored data will be encrypted into a Quick Response code embedded in a smart card. A unique identification number and participant's blood group type will be on the outside of the card. There will be no names or any other identifiers. Each participating center will identify a dedicated delivery room staff that will be trained to read the contents of the card using the cell phone application as well as enter new data in the participant's profile. When a participant presents at delivery without the card, information can still be obtained from the secure, web-based database and confirmed using the participant's name, date of birth and cell phone number. This information is provided to the clinician to guide management of the infant."
15981272|NCT03027245|Drug|Eribulin|
15981356|NCT03026543|Procedure|Pulmonary Recruitment Maneuver|
15981273|NCT03027232|Other|No intervention (drugs) will be given. Purpose: collecting blood for in vitro studies|No drugs or interventions are given. Single purpose is to draw blood from healthy subjects to study immune cell biology in vitro. No records about subjects to be kept.
15981274|NCT03027219|Drug|Alprostadil|Vasodilator for anastomosis-site of free flap
15981275|NCT03027206|Other|Vibration technique|Comparison of different technique
15981276|NCT03027206|Other|Acceleration of expiratory flow|Comparison of different technique
15981277|NCT03027193|Biological|ChAdOx2 HAV|The ChAdOx2 HAV vaccine consists of the replication-deficient simian adenovirus vector ChAdOx2, containing the Mycobacterium avium subspecies paratuberculosis (MAP) antigens
15981278|NCT03027193|Biological|MVA HAV|The MVA HAV vaccine consists of the replication deficient modified vaccinia virus Ankara (MVA) containing the Mycobacterium avium subspecies paratuberculosis (MAP) antigens.
15981279|NCT03027180|Device|Noninvasive positive airway pressure with different levels|
15981280|NCT03027167|Drug|Aspirin|
15981281|NCT03027167|Device|(Post- discharge) Mechanical Compression Device|
15981282|NCT03027154|Biological|ESAT6-CFP10 in left arm and TB-PPD in right arm|All subjects including TB subjects in 5-18 years old、non-TB subjects in 5-18 years old、TB subjects under 5 years old and non-TB subjects under 5 years old inject ESAT6-CFP10 in left arm and TB-PPD in right arm respectively. Two drug must use at the same participant and in different arms.
15981283|NCT03027154|Biological|ESAT6-CFP10 in right arm and TB-PPD in left arm|All subjects including TB subjects in 5-18 years old、non-TB subjects in 5-18 years old、TB subjects under 5 years old and non-TB subjects under 5 years old inject ESAT6-CFP10 in right arm and TB-PPD in left arm respectively. Two drug must use at the same participant and in different arms.
15981284|NCT03027141|Behavioral|Face recognition task|Inside the MRI scanner and during the experiment, participants will be asked to make judgments about the identity they perceived in each morphed picture.
15981285|NCT03027128|Biological|haNK™ for Infusion|haNK™ for Infusion is a human, allogeneic, NK cell line that has been engineered to produce endogenous, intracellularly retained IL-2 and to express CD16, the high-affinity (158V) Fc gamma receptor (FcγRIIIa/CD16a).
15981286|NCT03027115|Drug|Tamsulosin|Tamsulosin treatment for 7 days pre-operatively
15981287|NCT03027102|Biological|DNT cells|DNT cells will be expanded (increased in numbers) in the laboratory, in order to enhance their tumour destroying potential before infusion into AML patients.
15981288|NCT03027076|Procedure|Genitourinary Specimen Collection|Collect urethral swab, urine before prostatic massage (pre-M), urine after prostatic massage (post-M) and Expressed Prostatic Secretion (EPS)
15981289|NCT03027076|Procedure|Collect midstream urine samples|Collect midstream urine samples
15981290|NCT03027063|Behavioral|10,000 steps|Participants will be asked to achieve 10,000 steps daily and to participate in 30 minutes of continuous exercise of their choosing. They will also receive text messages during the week and weekly motivational call
15981291|NCT03027063|Behavioral|Usual Care|Participants will receive the ACC/AHA exercise guidelines
15981292|NCT03027050|Procedure|T-PRF|Applied for treatment of periodontal bone loss.
15981293|NCT03027050|Procedure|Open Flap Debridement alone|
15981294|NCT03027024|Device|Implantation of IOL: PhysIOL POD F GF|Implantation of trifocal IOL POD F GF consisting of hydrophobic material
15981295|NCT03027011|Procedure|Remote Ischemic Preconditioning|RIPC will be induced during anesthesia by 3 cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure 200mmHg
15981296|NCT03027011|Procedure|Control|Control group without remote ischemic preconditioning
15981297|NCT03026998|Procedure|MRI|MRI will be performed each year during 10 years.
15981298|NCT03026985|Other|Observational cohort|Ultrasound assessment of quadriceps, muscle strength testing, highest mobility level
15981299|NCT03026972|Biological|Placebo|The placebo drug contains 20mg mannitol and 10 millimole(mM) phosphate buffer(PB).population I～population IV are coxal muscle injection of placebo.
15981300|NCT03026972|Biological|Low dose adjuvant|Population I and polulation IV are coxal muscle injection of low dose adjuvant.
15981301|NCT03026972|Biological|High dose adjuvant|Population II ,Population III and Population IV are coxal muscle injection of high dose adjuvant.
15981302|NCT03026972|Biological|Low dose vaccine|Population I and population IV are coxal muscle injection of low dose vaccine.
15981303|NCT03026972|Biological|High dose vaccine|Population II,population III and population IV are coxal muscle injection of high dose vaccine .
15981304|NCT03026959|Behavioral|Mindfulness|The mindfulness intervention follows the structure described by Short, Mazmanian, Ozen, & Bédard, (2015).
15981305|NCT03026946|Drug|Alitretinoin|Oral alitretinoin capsule of 30mg once daily for a total of 24 weeks.
15981306|NCT03026946|Drug|cyclosporin A|Oral cyclosporine A start dose 5 mg/kg/day (split in 2 doses), decreasing the dose after 8 weeks to 3 - 3.5 mg/kg/day (split in 2 doses). The treatment period is 24 weeks.
15981307|NCT03026933|Drug|KI1107 4 Capsules, QD|KI1107 4 Capsules
15981308|NCT03026933|Drug|Rosuvastatin Calcium 20 MG, QD|Rosuvastatin Calcium 20mg, QD
15981309|NCT03026920|Procedure|less invasive method|The less invasive surgical method was conducted in this study. Then, the clinical results were compared with the patients treated using traditional methods to assess the less invasive method.
15981310|NCT03026907|Drug|Alitretinoin|Oral alitretinoin capsule of 30mg once daily for a total of 24 weeks.
15981311|NCT03026907|Drug|Azathioprine|Oral azathioprine tablets twice daily in a dose of 1.5 or 2.5mg/kg/day, depending on the thiopurine methyltransferase (TPMT) activity.
15981312|NCT03026894|Radiation|Panoramic Radiograph|Measurement of bone resorption
15981313|NCT03026894|Device|T-Scan III occlusal system|Recording percentage of force in maximum intercuspation
15981314|NCT03026881|Drug|Fluzoparib|Fluzoparib either at 20,30,40mg twice daily,capsule oral.
15981315|NCT03026881|Drug|Apatinib|Oral
15981316|NCT03026881|Drug|Paclitaxel|Intravenous injection
15981317|NCT03026868|Procedure|quadrilateral surface plate|Both anterior and posterior approaches were always conducted to manage the fragments of quadrilateral surface. Novel quadrilateral surface plate was used in this study to examine whether the fragments could be fixed through single Stoppa approach.
15981357|NCT03026543|Procedure|Laparoscopic cholecystectomy|
15981358|NCT03026543|Device|Ventilator|
15981318|NCT03026855|Biological|Autologous PRP Gel and PRP Injection|"Autologous PRP prepared using the Res-Q™ 60 PRP system from patient's whole blood, will be injected subcutaneously around the periphery of the wound/ulcer.
~Based on the wound size and area, autologous platelet gel obtained by spraying simultaneously equal volumes of PRP and activator solution (thrombin with calcium chloride) will be applied topically over the ulcer or wound.
~Single dose of PRP injections and application of PRP gel will be administered, only on the day of treatment."
15981319|NCT03026842|Drug|Decitabine|20 mg/m2/day for 5 days
15981320|NCT03026842|Drug|Daunorubicin, Cytarabine|Daunorubicin: 45 mg/m2/day for 3 days; Cytarabine: 100 mg/m2/day for 5 days
15981321|NCT03026842|Drug|Mitoxantrone, Cytarabine|Mitoxantrone: 8 mg/m2/day for 3 days; Cytarabine: 100 mg/m2/day for 5 days
15981322|NCT03026842|Drug|Aclacinomycin, Cytarabine|Aclacinomycin: 20 mg/day for 5 days; Cytarabine: 100 mg/m2/day for 5 days
15981323|NCT03026829|Device|CART sound therapy|"The study consists of two parts:
~Phase 1: laboratory evaluation of CART sound acceptability
~Phase 2: take home evaluation of CART sound therapy including baseline without CART"
15981324|NCT03026816|Device|Epidural Spinal Cord Stimulation|epidural spinal cord stimulator
15981325|NCT03026803|Drug|Oxaliplatin|Given IV
15981326|NCT03026803|Drug|Capecitabine|Given PO
15981327|NCT03026790|Other|Medication management|Individualized management of medications for pain
15981328|NCT03026790|Other|Non-pharmacological pain management|Individualized management of non-medication pain treatment approaches
15981329|NCT03026790|Drug|Buprenorphine-Naloxone|Option of using buprenorphine-naloxone to assist with opioid dose reduction or discontinuation
15981330|NCT03026777|Drug|intravenous crystalloid fluid, 500 mL|
15981333|NCT03026751|Procedure|Bone Marrow Aspirate|Bone marrow aspirate
15981334|NCT03026738|Procedure|Laparoscopic anterior mesh rectopexy|fixation of the rectum anteriorly using laparosopy and polypropylene mesh
15981335|NCT03026738|Procedure|Laparoscopic posterior mesh rectopexy|fixation of the rectum posteriorly using laparosopy and polypropylene mesh
15981336|NCT03026738|Device|polypropylene mesh|A strip of polypropylene mesh will be introduced and sutured.
15981337|NCT03026725|Other|Tri-calcium Phosphate|A paste contains Tri Calcium Phosphate & Fluoride
15981338|NCT03026725|Other|Placebo|paste manufactured to mimic Clinpro, without Tri Calcium Phosphate
15981339|NCT03026712|Device|Real dual tDCS + Robotic Arm Therapy|"Dual tDCS (anodic on injured hemisphere, cathodic on healthy hemisphere). Motor cortex will be simultaneously stimulated at an intensity equal to 1-2 mA and for a maximum duration of 20 minutes just before 30 minutes of arm robotic task oriented treatment performed with an exoskeleton device (Armeo Power).
~The intervention will be performed 5 times per week for 2 consecutive weeks."
15981340|NCT03026712|Device|SHAM tDCS + Robotic Arm Therapy|"SHAM bilateral tDCS for a maximum duration of 20 minutes just before 30 minutes of arm robotic task oriented treatment performed with an exoskeleton device (Armeo Power).
~The intervention will be performed 5 times per week for 2 consecutive weeks."
15981341|NCT03026699|Behavioral|eSNAP|Participants in the intervention group will then be given a tablet loaded with the eSNAP application and asked to create a visualization of their social networks. Upon completion, participants will be asked to review their ecomaps and complete the user experience questionnaire.
15981342|NCT03026699|Behavioral|Questionnaires|Participants will complete demographics and baseline (T1; baseline) questionnaires. For all participants Time 2 (T2; 3 week) and Time 3 (T3; 6 week) questionnaires will be completed either by phone, mail, or email (depending on participant preference) to assess longer-term effects of eSNAP on outcomes versus controls.
15981343|NCT03026673|Other|NSAID use|The purpose of the study is to establish that NSAIDS are an appropriate analgesic to be used in the postpartum period, and thus women in the immediate postpartum period are the focus of this study.
15981344|NCT03026660|Dietary Supplement|Moringa Oleifera|
15981345|NCT03026660|Dietary Supplement|Cabbage Placebo|
15981346|NCT03026647|Procedure|Suture|To examine different types of suture material used for hysterotomy closure in cesarean section and determine if one is preferred above other types due to a complications profile.
15981347|NCT03026634|Behavioral|Sleep-disordered breathing|Prevalence and dynamic of sleep-disordered breathing after heart transplantation
15981348|NCT03026621|Dietary Supplement|Lignite Extract|"The study design is a double-blind case-control trial, whereby half of the participants will be cases and will be asked to take 5mL 'Restore' mineral supplement three times each day. The other half of the participants will be controls and will be asked to take 5mL of a placebo three times each day. Both the study leader and the participants will be blinded to who receives Restore and who receive placebo."
15981349|NCT03026621|Other|Herbal tea|This is an herbal tea that will look like the control
15981350|NCT03026608|Behavioral|Veggie Van Program|This includes 1.) Weekly delivery of fresh local produce; 2.) Cooking and nutrition demonstrations; 3.) Weekly newsletters about cooking, nutrition and local produce mailed to all study participants and distributed at Veggie Van
15981351|NCT03026595|Other|no intervention|no intervention
15981352|NCT03026582|Device|Intestinal ultra-sound monitoring|Children diagnosed with either CD or UC will be enrolled at diagnosis or at any time point during follow-up. Patients' characteristics will be retrieved from their medical files including demographic details, disease phenotype, endoscopic and radiologic variables, anthropometric measures, laboratory evaluation, complication and therapeutic regimens. At enrollment and every 3 months for a total period of 2 years all patients will perform intestinal US during regular clinic visits. All other measures including laboratory exams, anthropometric measurements and disease activity indices (either PCDAI for CD or PUCAI for UC) will be performed as part of standard of care.
15981353|NCT03026569|Other|Orange juice (500 mL/d)|The patients were instructed to drink orange juice in two daily portions during eight consecutive weeks. Patients from both groups were asked to maintain their usual lifestyle, diet, and physical activity, and they were checked weekly by the researcher's team. Assessments of anthropometric data, dietary intake, as well as blood sample collection for biochemical analysis were performed in all participants on the first and last day of the experiment.
15981359|NCT03026530|Procedure|Pulmonary recruitment maneuver|The participants in the experimental arm receives 1 minute of ventilator-piloted pulmonary recruitment with positive inspiratory pressure set to 40 cm H2O, at the end of laparoscopic bariatric surgery.
15981360|NCT03026530|Procedure|Laparoscopic bariatric surgery|
15981361|NCT03026530|Device|Ventilator|
15981362|NCT03026517|Drug|Dabrafenib|
15981363|NCT03026517|Drug|Trametinib|
15981364|NCT03026517|Drug|Phenformin|
15981365|NCT03026504|Drug|Baricitinib|4 milligrams oral Baricitinib daily for 52 weeks
15981366|NCT03026491|Other|Chewing evaluation|Each child was required to bite and chew a standardized biscuit while chewing video recording. Chewing function was scored with the Karaduman Chewing Performance Scale (KCPS).
15981367|NCT03026478|Drug|Betamethasone Dipropionate|
15981368|NCT03026478|Drug|Clobetasol Propionate|
15981369|NCT03026465|Device|Polymer-free stent|PCI using a polymer-free dual-drug sirolimus- and probucol-eluting stent (Coroflex ISAR)
15981370|NCT03026465|Device|Biodegradable-polymer stent|PCI using a biodegradable-polymer biolimus-eluting stent (Biomatrix)
15981371|NCT03026452|Procedure|US-guided RFA|The investigators used percutaneously US-guided radiofrequency ablation for patients with small hepatocellular carcinoma,and estimated the safety and efficacy of this treatment through 2-year follow-up of US/CEUS/CT/MRI and the tumor markers.
15981372|NCT03026426|Behavioral|CONEMO|"Participants will be offered a behavioral activation-based intervention delivered by an application for smartphones (CONEMO) oriented to encourage them to be more active and to incorporate more activities in participants' everyday life.
~Nurses will train participants to use CONEMO, make phone calls when participants are non-adherent, and provide technical support when necessary. Nurses will be supervised by clinical psychologists."
15981373|NCT03026413|Procedure|pulmonary vein antrum modification|
15981374|NCT03026400|Procedure|Transumbilical incision|While both types of incision were considered equal regarding the potential clinical outcome, the investigators considered the transumbilical incision to be the ''intervention'' and the subumbilical incision to be the ''standard care comparator'' since the transumbilical incision take a few more minutes to be completed.
15981375|NCT03026400|Procedure|Subumbilical incision|Considered here as the ''control'' intervention.
15981376|NCT03026387|Behavioral|Neuropsychological battery tests|"The neuropsychological battery tests is composed with: Continuous Performance Test, Iowa Gambling Test, Verbal fluency (animals), Emotional stroop, Self-injury implicit association test.
~The neuropsychological battery assesses domains heavily involved in suicidal behavior: impulsivity, affective dysregulation, alterations in decision-making (risky choices), selective attention and verbal fluidity"
15981377|NCT03026374|Behavioral|Be Resilient to Breast Cancer|This is a supportive-expressive group therapy.
15981378|NCT03026361|Genetic|global proteomic profiling|Global proteomic profiling was performed on OLP and OSCC samples and healthy mucosa. Obtained data was analysed in Uniprot database (http://uniprot.org) with the emphasis on extracellular matrix proteins. In total, 55 extracellular matrix proteins were found to be expressed in analysed samples with very high confidence.
15981379|NCT03026348|Biological|RSV F Vaccine with Aluminum Phosphate Adjuvant|
15981380|NCT03026348|Biological|RSV F Vaccine|
15981381|NCT03026348|Biological|Matrix-M1 Adjuvant|
15981382|NCT03026348|Other|Phosphate Buffer|
15981383|NCT03026335|Behavioral|Positive Action|Based upon a Cognitive Behavioral Therapy model, intervened schools were engaged in providing curriculum, school infrastructure elements, and parent/community involvement activities around a single model aimed to provide positive support for behaviors. Six areas were identified: self-concept, body/mind, responsible self-management, treating others they way you want to be treated, telling yourself the truth, and continual improvement of self.
15981384|NCT03026335|Behavioral|Control|Business as usual with students in non-itervened schools
15981385|NCT03026322|Other|Manual Ventilation|Beginning after the administration of sedation/neuromuscular blockade, manual ventilation will be provided by bag-valve-mask until the initiation of laryngoscopy. In patients requiring more than one attempt at laryngoscopy, bag-valve-mask ventilation will resume between laryngoscopy attempts.
15981386|NCT03026322|Other|No Manual Ventilation|Between the administration of sedation/neuromuscular blockade and intubation, ventilation will not be provided unless the patient experiences an arterial oxygen saturation less than 90%. For patients who experience an oxygen saturation less than 90% after induction, bag-valve-mask ventilation may be provided.
15981387|NCT03026309|Other|no intervantion|no intervention is being performed, only observational evaluations.
15981388|NCT03026296|Behavioral|Healthy Life Center|Depending on what behavior participants aim to change, they get individual counselling using elements from motivational interviewing, group-based exercise twice a week, diet courses and tobacco secession courses during three months
15981389|NCT03026283|Device|HeartFLow CT-FFR|Patients receiving CCTA to diagnose stable chest pain or stable angina will receive CT-FFR to estimate rate of flow through the coronary arteries. The rate of flow will be compared to the rate found on Invasive FFR (the gold standard) if the subject receives invasive FFR.
15981390|NCT03026270|Other|Paraffin|The application of paraffin wax will be performed with the patient in the supine position at rest for at least 10 min, then with an appropriate brush (5 cm wide), will spend several layers with the brush into two distinct groups, seven or ten layers depending on the outcome of randomisation, in the region of interest of the upper limb, being scarred, surrounded by a plastic film film remaining in the area for 15 minutes, and then discarded
15981391|NCT03026257|Device|Lotrafilcon B contact lenses with added wetting agent|Silicone hydrogel contact lenses
15981392|NCT03026257|Device|Samfilcon A contact lenses|Habitual silicone hydrogel contact lenses
15981393|NCT03026257|Device|POLYQUAD/ALDOX-preserved contact lens solution with added wetting agent|Multi-purpose disinfecting solution for contact lens care
15981394|NCT03026257|Device|Hydrogen peroxide-based contact lens solution with added wetting agent|Solution for contact lens cleaning and disinfecting
15981395|NCT03026257|Device|Senofilcon C contact lenses|Habitual silicone hydrogel contact lenses
15981396|NCT03026257|Device|Senofilcon A contact lenses|Habitual silicone hydrogel contact lenses with a replacement pair issued after 2 weeks
15981397|NCT03026257|Device|Comfilcon A contact lenses|Habitual silicone hydrogel contact lenses
15981398|NCT03026257|Device|Habitual Multi-Purpose Solution (HMPS)|Multi-purpose solution for contact lens care according to participant's habitual brand, used per manufacturer's instructions
15981399|NCT03026244|Dietary Supplement|Milk protein, prebiotics, vitamin D|3 weeks supplementation with milk protein only, followed by 3 weeks milk protein + prebiotics, followed by 3 weeks milk protein + prebiotics + vitamin D
15981400|NCT03026244|Dietary Supplement|Placebo product|3 periods of 3 weeks placebo product
15981401|NCT03026231|Biological|PRIM-DJ2727|Thirty eligible subjects with PD will be randomly assigned to receive either PRIM-DJ2727 in orally administered enteric-coated capsules or placebo capsules
15981402|NCT03026231|Drug|Placebo (for PRIM-DJ2727)|Thirty eligible subjects with PD will be randomly assigned to receive placebo capsules
15981403|NCT03026218|Other|GlucoseMama application with blood sugar monitoring and carb monitoring.|We will use the Glucosemama application to review glucose and carb logs on a weekly basis. This will be reviewed with the patient in order to adjust dietary and medicals.
15981404|NCT03026218|Other|Group prenatal care for GDM.|group prenatal care is a group based intervention where individuals with GDM will meet together to learn about pregnancy and diabetes.
15981405|NCT03026205|Drug|ARMS-I|
15981406|NCT03026192|Device|near infrared spectroscopy|Near infrared spectroscopy will be placed on infants both with and without hsPDA
15981407|NCT03026179|Behavioral|Play Nicely|Play Nicely is a multimedia program that teaches parents about appropriate methods to discipline.
15981408|NCT03026166|Drug|Ipilimumab|Administered by intravenous infusion
15981409|NCT03026166|Drug|Nivolumab|Administered by intravenous infusion
15981410|NCT03026166|Drug|Rovalpituzumab tesirine|Administered by intravenous infusion
15981411|NCT03026153|Behavioral|Control Group Oral Survey 1|Oral survey 1 will be administered as control intervention: patients will be asked how willing they would be to take an injectable medication to control their psoriasis which required once-monthly injections
15981412|NCT03026153|Behavioral|Intervention Group Oral Survey 2|Oral Survey 2 will be administered as the intervention: patients will be asked how willing they would be to take an injectable medication to control their psoriasis which required once-daily injections, then surveyor would ask how willing they would be to take an injectable medication which required only once-monthly injections
15981413|NCT03026140|Drug|Nivolumab|Nivolumab 3mg/kg (day 1 and day 15), administered neoadjuvant before surgery
15981414|NCT03026140|Drug|Ipilimumab|Ipilimumab 1 mg/kg (day 1) ,administered neoadjuvant before surgery
15981415|NCT03026140|Drug|Celecoxib 200mg|celecoxib will be administered starting day 1 until 1 day before surgery daily (if patient is randomized to group 2 (only applicable for patients with a MSS tumor)
15981416|NCT03026127|Behavioral|Cognitive Reappraisal Intervention for Suicide Prevention|Cognitive Reappraisal Intervention for Suicide Prevention, or CRISP, is a psychosocial intervention aimed to reduce suicide risk in middle-aged and older adults who have been hospitalized for suicidal ideation or suicide attempt. CRISP offers a combination of emotion regulation techniques, including changing the subject's perspective or the way he/she thinks to improve emotion reactions. Additional strategies taught include the provision of environmental adaptation tools (notes, checklists, calendars, etc), phone calls, and a tablet application called WellPATH.
15981417|NCT03026127|Behavioral|Supportive Therapy|ST focuses on: 1. facilitating expression of affect; 2. conveying to the patient that he or she is understood; 3. offering empathy; and 4. highlighting positive experiences. The ST manual aims to standardize nonspecific therapeutic factors
15981418|NCT03026114|Other|No intervention is planned in our study.|No intervention is planned in our study.
15981419|NCT03026101|Other|Nitroglycerin|Intra-arterial adminstration to dilate external carotid artery branches to replicate migraine pain
15981420|NCT03026088|Drug|Bisoprolol|Participants received Bisoprolol orally, once daily at a dose of 1.25 milligram (mg) up to Weeks 3, and then it was up-titrated to 2.5 mg up to Week 6, 3.75 mg up to Week 10, 5 mg up to Week 14, 7.5 mg up to Week 18 and 10 mg up to Week 26.
15981421|NCT03026075|Device|Motus Cleansing System (MCS)|The MCS enables colon cleansing during standard colonoscopy using a standard colonoscope. The cleansing device, which is attached to the tip of the colonoscope and is connected to an external workstation, generates fluid jets within the colon thus dissolving the feces into small parts. The fecal matter & fluids are drained through the evacuation pipe of the cleansing device into a collecting reservoir.
15981422|NCT03026062|Biological|Durvalumab|Given IV
15981423|NCT03026062|Biological|Tremelimumab|Given IV
15981424|NCT03026049|Device|deep venous stenting|Deep venous stent
15981425|NCT03026036|Radiation|PET Scan with Raclopride|A subsample (21 per group) will complete the PET imaging.
15981426|NCT03026023|Drug|Combindation treatment with Grazoprevir and Elbasvir fixed dose combination tablet, with or without ribavirin|HCV treatment for 12 to 16 weeks. Treatment length and addition of ribavirin based upon presence of baseline resistance associated variant in the HCV virus. Medications given concurrently.
15981427|NCT03026010|Procedure|central blood pressure|SphygmoCor XCEL will be used to measure both standard blood pressure in the arm and central pressure, the blood pressure at the heart.
15981428|NCT03025997|Dietary Supplement|Active yoghurt|Active yoghurt (containing encapsulated lipid) will be ingested after a standardized breakfast, and subsequently satiety and food intake will be measured.
15981429|NCT03025997|Dietary Supplement|Placebo yoghurt|Placebo yoghurt (containing non-encapsulated lipid) will be ingested after a standardized breakfast, and subsequently satiety and food intake will be measured.
15981430|NCT03025984|Behavioral|Texting|patient adherence to her recommended care regimen after intervention of a text message reminder and education system
15981431|NCT03025971|Device|J-Valve Transcatheter Aortic valve replacement|Transapical Transcatheter Aortic Valve Replacement
15981432|NCT03025958|Drug|Nimotuzumab|
15981433|NCT03025958|Radiation|Radiation|
15981434|NCT03025945|Drug|Nepafenac 0.3%|
15981435|NCT03025945|Drug|Saline Solution|
15981436|NCT03025932|Procedure|repair of giant hiatal hernia with mesh and anterior fundoplication|
15981437|NCT03025906|Drug|Phenobarbital|In the PB group, a loading dose of 20 mg/kg (may give an additional 10 mg/kg) begins at a rate of 50 mg/min followed by IV 100 mg q6 h.
15981468|NCT03025685|Procedure|Coronary stenting|A standard endovascular procedure of percutaneous coronary intervention with coronary stenting
15981438|NCT03025906|Drug|Valproate|In the VPA group, a loading dose of 30 mg/kg (may give an additional 15 mg/kg) begins at a rate of 3 mg/kg per min followed by a continuous infusion at a rate of 1-2 mg/kg per hour.
15981439|NCT03025893|Drug|Sunitinib|Sunitinib, 300 mg administered orally in a weekly schedule.
15981440|NCT03025893|Drug|Lomustine|Lomustine 110 mg/m2, taken orally on day 1 every 6 weeks.
15981441|NCT03025880|Drug|Pembrolizumab|Pembrolizumab at a dose of 200mg as an intravenous (IV) 30 minutes infusion on day 1 of each 21-day cycle. Treatment will be repeated on day 1 of each 21-day cycle until objective disease progression, clinical progression (under investigator criteria), unacceptable toxicity, death or withdrawal of consent, whichever occurs first. Patients completing 24 months of uninterrupted treatment with pembrolizumab or 35 administrations of study medication will stop pembrolizumab treatment (though may continue with gemcitabine). Subjects who stop pembrolizumab after 24 months may be eligible for up to one year of additional pembrolizumab treatment if they progress after stopping it.
15981442|NCT03025880|Drug|Gemcitabine|Gemcitabine at a dose of 1,250mg/m2 as an intravenous (IV) 60 minutes infusion on day 1 and 8 of each 21-day cycle. Treatment will be repeated on day 1 of each 21-day cycle until objective disease progression, clinical progression (under investigator criteria), unacceptable toxicity, death or withdrawal of consent, whichever occurs first.
15981443|NCT03025867|Drug|Niraparib|
15981444|NCT03025841|Drug|Ceftaroline|
15981445|NCT03025828|Drug|ACTHar|for 6 months
15981446|NCT03025815|Other|Intervention group|Oral stimulation program consists of the a 15 minutes stimulation program, whereby the first 12 minutes involved stroking the cheeks, lips, gums, and tongue, and the final 3 minutes consists of sucking on a pacifier routinely.
15981447|NCT03025815|Other|Control group|sham stimulation program consists of the same researcher placing her hands for 15 minutes.
15981448|NCT03025789|Drug|Fexinidazole|Tablets of 600 mg Patients with a weight between 20 and 34kg: 1200mg for 4 days, then 600mg for 6 days Patients with a weight of 35kg and above: 1800mg for 4 days, then 1200mg for 6 days
15981449|NCT03025776|Behavioral|Reaching|sitting reaching under various task conditions (size, speed, location)
15981450|NCT03025776|Behavioral|Kinematic collection while reaching|sitting reaching under various task conditions (size, speed, location), told how many & which hand to use, kinematic data collected
15981451|NCT03025763|Other|Craniosynostosis Network Environmental Survey|Questionnaire is administered to the mothers of affected participants regarding medical history and environmental exposures during pregnancy, delivery, and neonatal period. Optional.
15981452|NCT03025763|Other|2D/3D Photography|Full frontal and lateral face and other parts of the body may be taken for dysmorphic assessment. There is the risk of identification and loss of confidentiality. Optional.
15981453|NCT03025763|Procedure|Buccal Swab Cell Sampling|One or more swabs, like a Q-tip (for children), or saliva collection kit (for adults) will be used to collect buccal cells. With a swab, they will brush the inside of the mouth several times. With saliva collection kit, they will collect their saliva by spitting into a container several times using a commercially available saliva collection kit. Required.
15981454|NCT03025763|Procedure|Blood sampling|Venipuncture so that one teaspoon to tablespoons (1-20 ml.) of blood is collected. The volume drawn will be dependent on the age and size of the child. Minimal amounts may be required for DNA, but to establish a lymphoblastoid or iPS cell line at least 3 to 10 ml will be required independent of age. In the case of an infant, if 3 to 10 ml cannot be obtained, then a lymphoblastoid or iPS cell line will not be created. Optional.
15981455|NCT03025763|Procedure|Skin Biopsy|For those who do not undergo surgery or the skin removal is not considered part of the surgical procedure. After proper cleaning, a piece of skin the size of a pencil eraser (about 4 mm or 1/8 inch in diameter) will be removed (using a circular blade or scalpel) from the arm (inside of arm or forearm in a spot that is as unnoticeable as possible). This area will be covered with a Band-Aid. No stitches are usually required. A crust will form and eventually fall off. Optional.
15981456|NCT03025763|Procedure|Tissues from a Clinically Indicated Procedure|In some instances when there is discarded tissues and specimens (including skin and bone at the time of reconstructive craniofacial surgery), they will be collected by making arrangements with their physicians. Some of these tissues will be used to generate cell lines. Optional.
15981457|NCT03025763|Procedure|Pre-operative CT Scan Image Files.|Optional for those who had a previous CT scan for a prior traumatic event.
15981458|NCT03025750|Biological|IPV-Al SSI|Total of three primary injections of IPV-Al SSI, one at 2, 4 and 6 months of age
15981459|NCT03025750|Biological|IPV SSI|Total of three primary injections of IPV SSI, one at 2, 4 and 6 months of age
15981460|NCT03025724|Drug|Levulan Kerastick|Intervention group subjects will undergo a surgical excision of the tumor. Then a clear transparency film will be used to trace the clinical margins of the lesion, as well as any other distinctive skin markings such as nevi or birthmarks. Subjects will then undergo the study procedure where the area to be treated will be swabbed with an alcohol wipe and allowed to dry. Next, the investigator will apply topical 20% 5-ALA (Levulan Kerastick; DUSA Pharmaceuticals) to the SCCis. Then, the area will be occluded with Tegaderm film for 3 hours.
15981461|NCT03025724|Device|blue light source|At the end of the incubation period, the Tegaderm will be removed and the patient will be exposed to a blue light source (BLU-U; DUSA Pharmaceuticals).
15981462|NCT03025724|Other|participant satisfaction survey|Participants will be asked to fill out a satisfaction survey.
15981463|NCT03025698|Drug|Eltrombopag|Tablet for oral use, once daily or Powder for oral suspension (PfOS), once daily
15981464|NCT03025698|Drug|hATG|Horse ATG (ATGAM) (hATG) is not considered an investigational medicinal product (IMP)
15981465|NCT03025698|Drug|CsA|Cyclosporine (CsA) will be by supplied as either oral capsules or oral solution, administered twice a day
15981466|NCT03025685|Procedure|TRUST technique|A soft hydrophilic wire easily pass through the invisible small vessels in the distal parts of a coronary artery into a heart cavity. It is necessary to pass a wire softly and forward as deep as possible. Quite often the wire goes through the left ventricle to aorta arch, and sometimes distal soft tip can be visible in a descending aorta. Thus the stiffest part of the wire become staying on all length of artery, straightening bends and giving the maximum support. After that balloons and stents can be delivered more easily
15981467|NCT03025685|Procedure|Anchoring Technique|A standard endovascular technique of coronary wire support improvement
15981469|NCT03025659|Other|Pyruvate levels|An additional 1 ml of arterial blood will be drawn at each routine postoperative blood draw (Hour 0, 1, 2, 3, 4, 6, 8, 10, 12, 24, 36, and 48 for participants 10kg and above or only at Hour 0, 2, 4, 6, 8, and 12 for infants under 10 kg) to measure the concentration of pyruvate in blood.
15981470|NCT03025646|Other|Mental Health care services & home based training|"From day 0 of the study period we will initiate setting up the intervention in two schools, which will include two components:
~Implementing mental health care services at schools targeting the mothers diagnosed as having depression who have consented to participate in the study (intervention mother).
~Psychologists will provide counseling session over 4-6 months period. Every month a psychiatrist will visit each school for reviewing the records of the mothers and mothers will be referred to the National Institute of Mental Health (NIMH) if necessary
~Organizing training sessions of the intervention mothers for supporting enhanced child care at home.
~Organizing training of the intervention mothers by special educator through a parental training module in the schools. Special educator will conduct refresher training at home every month."
15981471|NCT03025633|Other|PEARL|PEARL, is a commercially available PC-based tool that provides a realistic and functional 3D model of a linac and, having uploaded example treatments it can demonstrate the treatment procedure and also relevant anatomical information.
15981472|NCT03025620|Dietary Supplement|Rapeseed oil|Active comparator arm : Dietary Supplement: rapeseed oil supplementation (10g per day) and margarine with a high level of alpha-linolenic acid (12.5g per day) during 42 days.
15981473|NCT03025620|Dietary Supplement|Sunflower oil|Placebo comparator arm : Dietary Supplement: sunflower oil supplementation (10g per day) and margarine with a high level of inoleic acid (12.5g per day) during 42 days.
15981474|NCT03025607|Device|JOOL Health Mobile Phone Application|JOOL Health is a mobile phone-based application that aims to increase autonomous motivation to prevent T2DM by helping individuals make connections between certain health behaviors and the energy and willpower needed to achieve personal goals. On a daily basis, JOOL Health users chart the following health behaviors: Sleep, Presence, Activity, Creativity, and Eating. On a weekly basis, JOOL Health users are asked to record how well they lived according to their purpose and values. Through the integration of user-entered information with contextual data, JOOL Health provides tailored messaging and daily predictions of individuals' energy and willpower.
15981475|NCT03025594|Drug|Gonyautoxins|Periarticular infiltration of 40mcg of Gonyautoxin diluted in 30cc of Sodium Chloride 0.9%, with pH 6.2 and isosmotic. This solution will be administer targeting posterior capsule, both retinaculum, collateral ligaments, quadriceps and patelar tendon and subcutaneous tissue just before wound closure of total knee arhroplasty
15981476|NCT03025594|Drug|Chirocaine ketorolac epinephrine|Periarticular infiltration of 150ml of Chirocaine 2%, 60mg of ketorolac and 0.75mg of epinephrine. This solution will be administer targeting posterior capsule, both retinaculum, collateral ligaments, quadriceps and patelar tendon and subcutaneous tissue jbefore wound closure of total knee arhroplasty.
15981477|NCT03025581|Other|Nipple stimulation|For the intervention group participants will be instructed to gently massage alternate breasts, especially around the nipples for 15 minutes every 6 hours until the appearance of regular contractions but not more than 24 hours. Moist cloth or lubricating or moisturizing cream will be offered to facilitate the procedure according to individual preferences. In the control group all participants will be asked to avoid any breast stimulation during the study period.
15981478|NCT03025568|Other|PEEK|PEEK (poly-ether-ether-ketone) has been successfully used over the last years in the medical ﬁeld, and orthopedics, speciﬁcally. which presents high biocompatibility, good mechanical properties, high temperature resistance, and chemical stability due to a 4 GPa modulus of elasticity, it is as elastic as bone and can reduce stresses transferred to the abutment teeth. Additional advantages of this polymer material are elimination of allergic reactions and metallic taste, high polishing qualities, low plaque afﬁnity, and good wear resistance, it has only recently been used in dentistry.
15981479|NCT03025568|Other|Bre.flex|In the recent time thermoplastic materials (breflex) become quite popular in clinical practice such as nylon and acetal resins. since the 1950, polyamide resin (nylons) provide improved esthetics and reduction of rotational forces on the abutment teeth due to their low elastic modulus.
15981480|NCT03025555|Other|PEEK|"Polyetheretherketone (PEEK) is a synthetic, tooth colored polymeric material that has been used as a biomaterial in orthopedics for many years but recently used as removable prosthetic material. Advantages of this polymer material are elimination of allergic reactions, high polishing qualities, low plaque affinity, and good wear resistance.
~It has been proven that it shows high mechanical and biological properties. Studies evaluating the properties of this material are limited and need more clinical tests."
15981481|NCT03025555|Other|Bre.flex|Bre.flex is a nylon-based thermoplastic material, composed of nylon PA 12 (polyamide).Nylon exhibits high physical strength, heat resistance and chemical resistance. It can be easily modified to increase stiffness and wear resistance. Nylon resin can be semi-translucent and provides excellent esthetics but it is a little more difficult to adjust and polish.
15981482|NCT03025542|Drug|Bimekizumab|Based on their randomization subjects will receive a combination of several injections of Bimekizumab.
15981483|NCT03025542|Other|Placebo|Subjects will receive injections of Placebo.
15981484|NCT03025529|Device|Transcranial Magnetic Stimulation|Transcranial Magnetic Stimulation or TMS is a noninvasive procedure (meaning it does not enter the body) that is used to stimulate a part of the brain using a magnetic field. This magnetic field can pass through the head safely and painlessly. TMS can be used to change activity in the brain.
15981485|NCT03025529|Device|Sham Transcranial Magnetic Stimulation|Sham Transcranial Magnetic Stimulation or sham TMS is like active TMS, a noninvasive procedure (meaning it does not enter the body) that is used to stimulate a part of the brain using a magnetic field. TMS can be used to change activity in the brain but in this intervention, the coil will be angled 90 degrees from the scalp, resting on one wing of the coil, and therefore will not be delivering active TMS.
15981517|NCT03025282|Drug|CD10367 3% Solution - Desquamated zone|Once daily application for 3 weeks
15981518|NCT03025282|Drug|CD10367 solution placebo - Desquamated zone|Once daily application for 3 weeks
15981519|NCT03025269|Drug|Ocrelizumab|This is not a drug intervention study, we are doing an observational study with those who have been prescribed Ocrelizumab by their neurologists during clinical routine appointments
15981520|NCT03025256|Biological|Nivolumab|Given IV or IT
15981609|NCT03024580|Drug|Anastrozole 1Mg Tablet|Anastrozole 1 mg PO daily OR
15981486|NCT03025516|Device|Rapid Biosensor Systems (RBS) TB Breathalyser|Rapid Biosensor Systems (RBS) recently developed a portable, non-invasive, rapid TB diagnostic 'Breathalyser' capable of diagnosing TB in patient breath samples collected while patients cough (Figure 1). The TB Breathalyser comprises a disposable, single-use sample collection tube and a multi-use reader. At the bottom of the collection tube is a glass bio-sensor coated with a biochemical sensor that is formulated to react with TB bacilli. Patients cough into the collection tube after nebulization with 0.9% saline solution. Following sample collection, the tube is placed into the reader, where a diode laser interrogates the biochemical coating in the sample collection tube and reports the presence of TB bacilli. The entire process takes about two minutes.
15981487|NCT03025516|Device|eNose AeonoseTM|The eNose Company has also developed a hand-held, non-invasive rapid TB diagnostic 'electronic nose' (AeonoseTM) for TB detection based upon analysis of exhaled breath. After the device has been calibrated, the patient is instructed to breathe into the device through a mouthpiece for 5 minutes. Within the device is a micro-hotplate, metal-oxide sensor which behaves as a semiconductor at high temperature. Redox-reactions occurring at the sensor surface result in changes in resistance, with results read and interpreted by a phone application to confirm the presence of MTB.
15981488|NCT03025503|Other|nipple stimulation|
15981489|NCT03025490|Device|Capnographic monitoring|Capnographic monitoring is used during the sedation.
15981490|NCT03025477|Drug|CC0 - Carboplatin (IV) - Paclitaxel (IV)|(6 cycles)
15981491|NCT03025477|Drug|CC0 - Cisplatin (IP) - Epirubicin (IV)|(6 cycles)
15981492|NCT03025477|Drug|CC>0 - Carboplatin (IV)- Paclitaxel (IV)|"carboplatin (IV) - paclitaxel (IV) (3 cycles)
~Interval surgery
~Carboplatin (IV) - paclitaxel (IV) (3 cycles)"
15981493|NCT03025477|Drug|CC>0 - Cisplatin (IP/IV)- Epirubicin (IV)|"Cisplatin (IV) - Epirubicin (IV) (3 cycles)
~Interval surgery :
~if CC0: Cisplatin (IP) - Epirubicin (IV) (3 cycles)
~if CC>0 Cisplatin (IV)- Epirubicin (IV) (3 cycles)"
15981494|NCT03025464|Device|Obstructive Sleep Apnea Screening Device|Assessment of ability of device to detect apneas and hypopneas to screen for OSA
15981495|NCT03025451|Behavioral|The Complete Health Improvement Program|CHIP focuses on food, diet, activity, exercise, stress management, by viewing videos, cooking demonstrations, discussion, and exercise. Intervention nurtures intelligent self-care through enhanced understanding of the epidemiology, etiology, and risk factors associated with chronic lifestyle related diseases. The primary focus is the consumption of plant-based whole foods, such as fresh fruits, vegetables, whole grains, legumes, and nuts. The goal was to keep dietary fat below 20% of total calories, daily intake of added sugar below 10 tsps, sodium below 2,000 mg, and cholesterol below 50 mg. High fiber food intake (>35 g/day) is encouraged, and flexibility exercises, a daily walk of 30 minutes or 10,000 steps and daily use of stress management techniques.
15981497|NCT03025412|Procedure|endoscopic surgery|Ambulatory surgery. Same surgeon for all patients. General anesthesia. Full debridement of the paratenon and crural fascia. Also the plantaris longus tendon is debrided, but no additional tenotomy executed. Postoperative rehabilitation. Oral nonsteroidal anti-inflammatory drugs 7 days postoperatively. Active ankle dorsiflexion and plantar flexion from day 1 postoperative. Partly weight bearing (30 kg) from day 1 postoperative. Full weight bearing allowed from week 3 postoperative. Gradually increased load, both in activity of daily living, stationary bike and stretching, with individually and pragmatic progression due to pain response. From week 6 postoperative the patients start the same exercise regimen as the conservative treatment group.
15981498|NCT03025412|Behavioral|physiotherapy and exercise|Exercise schedule: Weeks 1-6, Eccentric unilateral loading while standing on the step of a staircase performed in two exercises; with straight knee and with bent knee. Weeks 7-9, Eccentric - Concentric loading while standing on the step of a staircase performed with straight knee and bent knee. Dose: 15 repetitions x 3 performed with straight knee, and 15 repetitions x 3 performed with bent knee. 3 - 4 times a week. Weeks 10-12, Eccentric - Concentric loading while standing on the step of a staircase performed with straight knee and bent knee. Dose: 15 repetitions maximum (15RM) x 3 performed with straight knee, and 15 RM x 3 performed with bent knee. 3 - 4 times a week. One leg performance or hand hold weight for extra load is used to obtain the exact number of RM.
15981499|NCT03025399|Drug|Tangwang prescription|A kind of Granule(Tangwang prescription) was composition by five Chinese herbal medicines, every bag has 4.87g granules.
15981500|NCT03025399|Drug|Placebo|Placebo is a simulated drug of tangwang prescription,included weight, appearance, colour, taste,smell and solubility.
15981501|NCT03025386|Other|logatoms test|A forced choice test will evaluate the discrimination of the most confusing logatoms in the cochlear implant users, and representative of the French language.
15981502|NCT03025386|Other|Electroencephalography|Mesure of the mismatch negativity wave
15981503|NCT03025373|Other|Visuo-acoustic stimulation|Controlled visual and acoustic stimulation in a virtual reality setting
15981504|NCT03025360|Drug|Larotrectinib (Vitrakvi, BAY2757556)|Larotrectinib will be administered orally as capsule or liquid solution as specified by the treating physician.
15981505|NCT03025347|Other|Control|Participants complete a resting control condition instead of a run.
15981506|NCT03025347|Other|Exercise|Participants complete a 60 minute run at 70% of their maximal oxygen uptake
15981507|NCT03025334|Device|High-definition transcranial direct current stimulation|brain stimulation to increase neuronal excitability in the targeted regions
15981508|NCT03025321|Device|transcranial Direct Current Stimulation (tDCS)|tDCS is an electrical brain stimulation method Participants will receive real-tDCS or sham twice daily for 13 min with an interval of 20 min for five consecutive days.
15981511|NCT03025295|Drug|Dexmedetomidine|Dexmedetomidine is common used to improve the prognosis and life quality of patients.
15981512|NCT03025295|Drug|Saline|It is safe Placebo.
15981513|NCT03025282|Drug|CD10367 3% Solution - Non-desquamated zone|Once daily application for 3 weeks
15981514|NCT03025282|Drug|CD10367 1% Solution - Non-desquamated zone|Once daily application for 3 weeks
15981515|NCT03025282|Drug|CD10367 solution placebo - Non-desquamated zone|Once daily application for 3 weeks
15981516|NCT03025282|Drug|Betneval ointment - Non-desquamated zone|Once daily application for 3 weeks
15981521|NCT03025243|Device|computer aided surgical guide|comparing accuracy of surgical guide of printing layer thickness of 50 micron and 100 micron by superimposition of pre-operative and post-operative CBCT
15981522|NCT03025230|Other|Dry needling and electric stimulation|Dry needling technique and the application of electric stimulation of levator scapulae PG
15981523|NCT03025230|Other|Dry needling|Treatment of PG with a filiform needle in levator scapulae muscle
15981524|NCT03025217|Behavioral|Total Lifestyle Coaching (TLC)|
15981525|NCT03025204|Biological|Enamel Matrix Proteins|EMD is composed of different proteins, 90% of which are amelogenins, which has the capacity to induce processes involved in the regeneration of periodontal tissues in a manner similar to normal tissue development (48). Several clinical and animal model studies have demonstrated the use of enamel matrix-derived proteins in regenerative periodontal procedures for the formation of a new periodontium.
15981526|NCT03025204|Procedure|Open Flap Debridement|After administration of local anesthetics, full-thickness flaps will be raised in order to access all defect faces. Sulcular incisions will be performed extending to mesial and distal adjacent teeth, including the entire papilla in the flap. No relaxing incisions will be performed. All granulation tissue will then be carefully removed, and subsequently scaling and root planing will be performed. The surgical area will be irrigated with 0.9% saline and carefully inspected to ensure that all steps have been satisfactorily performed until then.
15981527|NCT03025191|Behavioral|Speaker/Listener technique|Couple will learn taking turns as the speaker and as the listener who paraphrases the speaker's point.The couple will then identify an issue they have faced in their relationship and will role-play using the technique to discuss it.
15981528|NCT03025191|Behavioral|Social Support|Identification of and mapping sources of social support and the types of support provided by members of the network. Participants will also identify the strengths and weaknesses of their support network and think through ways to strengthen those networks.
15981529|NCT03025191|Behavioral|Problem-Solving|Couple will be taught steps to systematically analyze a problem and brainstorm solutions through a short video. Steps include identify the trigger/problem; identify the goal for addressing the problem; brainstorm possible solutions for each partner; evaluate the solutions and pick the best; and act on the best solution.
15981530|NCT03025191|Behavioral|Goal Setting|Couple will be introduced to the concept of short- and long-term goal setting, including components of goal and planning for potential barriers. The couple will then set a goal for themselves that incorporates the skills obtained during the intervention, such as strengthening ties in their social support network. Participants will fill in a worksheet outlining their goal, potential barriers, and solutions to those barriers.
15981531|NCT03025178|Procedure|4Fr central venous catheter insertion|The central venous catheter is placed at left internal jugular vein in infant, and its tip is confirmed by transthoracic echocardiography.
15981532|NCT03025165|Other|Community Adherence Clubs|Provision of ART care in the community to a club of 20-25 HIV+ patients
15981533|NCT03025165|Other|Home-Based ART Delivery|Provision of ART care to an individual at their home
15981534|NCT03025165|Other|Standard of Care|Delivery of ART adherence support, symptom screening and dispensation of medications at the local clinic according to local guidelines.
15981535|NCT03025152|Dietary Supplement|Hou Gu Mi Xi|Hou Gu Mi Xi is a dietary therapy form of Shen Ling Bai Zhu San, which removes atractylodes and platycodon grandiflorum, adds perilla leaf for adapting a dietary therapy.
15981536|NCT03025152|Other|placebo|The placebo has same appearance, taste and smell as Hou Gu Mi Xi.
15981537|NCT03025139|Other|Educational Intervention|Attend survivorship education
15981538|NCT03025139|Other|Laboratory Biomarker Analysis|Correlative studies
15981539|NCT03025139|Procedure|Meditation Therapy|Attend mindfulness meditation
15981540|NCT03025139|Other|Questionnaire Administration|Ancillary studies
15981541|NCT03025126|Other|Multimedial Rehabilitation|
15981542|NCT03025126|Other|Usual care program|Usual care at home program according to healthcare professional's advice
15981543|NCT03025113|Drug|ketoprofen and cyclobenzaprine association|The patient will take 2 tablets (Combination of ketoprofen and cyclobenzaprine), oral, per day, each 12h.
15981544|NCT03025113|Drug|Cyclobenzaprine|The patient will take 2 tablets (cyclobenzaprine), oral, per day, each 12h.
15981545|NCT03025087|Drug|Hydroxychloroquine|Participants will be getting hydroxychloroquine
15981546|NCT03025061|Other|Assessment of E-nose measurements|Breath sampling through E-nose pneumopipe
15981547|NCT03025048|Behavioral|A holistic dietary intervention for persons with spinal cord injury|A lifestyle program over 9 weeks combining individual consultations with a dieatitian and interdiciplinary group sessions
15981548|NCT03025035|Drug|Pembrolizumab|Pembrolizumab IV solution administered on Day 1 of each 3-week cycle
15981549|NCT03025035|Drug|Olaparib|Olaparib administered orally twice a day
15981550|NCT03025022|Drug|14C-JNJ-42847922 40 mg|Participants will receive a single 40 mg oral dose of 14C-JNJ-42847922 containing maximally 100 MicroCurie as a 40 milliLitre (mL) solution.
15981551|NCT03025009|Drug|LY3192767|Administered SC.
15981552|NCT03025009|Drug|Basal Insulin Peglispro|Administered SC.
15981553|NCT03025009|Drug|Insulin Glargine|Administered SC.
15981554|NCT03025009|Drug|Placebo|Administered SC.
15981555|NCT03024996|Drug|Atezolizumab|Atezolizumab 1200 mg IV infusion q3w
15981556|NCT03024996|Other|Placebo|Placebo matching to atezolizumab q3w
15981557|NCT03024983|Other|Glucose|Glucose monohydrate (55 g) dissolved with 500 mL of water
15981558|NCT03024983|Other|Semolina soup|Semolina soup (322 g) eaten with 500 mL of water
15981559|NCT03024983|Other|Bread|Bread (122 g) eaten with 500 mL of water
15981560|NCT03024983|Other|Penne (fresh)|Cooked penne (132 g) eaten with 500 mL of water
15981561|NCT03024983|Other|Penne (dry)|Cooked penne (142 g) eaten with 500 mL of water
15981562|NCT03024983|Other|Spaghetti (dry)|Cooked spaghetti (142 g) eaten with 500 mL of water
15981563|NCT03024970|Device|stenfilcon A lens with solution additive (test)|silicone hydrogel lens
15981564|NCT03024970|Device|stenfilcon A lens (control)|contact lens
15981565|NCT03024957|Drug|Morphine Sulfate|Intrathecal injection as the patients will be placed in the sitting position and a 25-gauge Quincke needle will be placed in the L2-3 or L3-4 interspaces with injection of morphine sulphate .
15981566|NCT03024957|Drug|Dexmedetomidine|Intrathecal injection as the patients will be placed in the sitting position and a 25-gauge Quincke needle will be placed in the L2-3 or L3-4 interspaces.
15981567|NCT03024957|Drug|Bupivacaine|Intrathecal injection as the patients will be placed in the sitting position and a 25-gauge Quincke needle will be placed in the L2-3 or L3-4 interspaces.
15981568|NCT03024944|Drug|18F-THK-5351|Intravenous (IV) catheter (tube) placed in participant arm. A small amount of 18F-THK-5351 will be injected into the IV enough time has passed for this contrast to collect in the tissue in the brain (approximately one half-hour), and participant will lie on a bed which slides into a PET Scanner to complete Tau imaging.
15981569|NCT03024931|Other|observational study|No intervention
15981570|NCT03024905|Behavioral|Village meeting and travel vouchers|"The interventions are:
~Village meetings by community health workers to educate women and their families about safe birthing.
~Vouchers for free transport by motorcycle taxi drivers to access health facility at delivery."
15981571|NCT03024905|Device|Birth kit with misoprostol|Provision of birth kit with clean delivery supplies (soap, 2 pairs of gloves, 2 cord clamps, surgical blade, and 600 mcg misoprostol for the woman to take immediately after the delivery to prevent postpartum hemorrhage).
15981572|NCT03024892|Procedure|ICG GB|ICG was given by intra-gallbladder injection, then the near-infrared image guide laparoscopic cholecystectomy were performed.
15981573|NCT03024892|Procedure|ICG IV|ICG was given by systemic injection, then the near-infrared image guide laparoscopic cholecystectomy were performed.
15981574|NCT03024892|Procedure|LC conventional|simple laparoscopic cholecystectomy was performed under white light image.
15981575|NCT03024892|Procedure|LC conventional and IOC|simple laparoscopic cholecystectomy was performed under white light image and intraoperaitve cholangiography guidance.
15981576|NCT03024879|Drug|Erythromycin|
15981577|NCT03024879|Drug|Saline|
15981578|NCT03024853|Behavioral|BPS PAST|
15981579|NCT03024853|Behavioral|BPS PRESENT|
15981580|NCT03024853|Behavioral|BPS FUTURE|
15981581|NCT03024853|Behavioral|CONTROL|
15981582|NCT03024840|Drug|Sevoflurane|Sevoflurane: 1%~2%
15981583|NCT03024840|Drug|Propofol|Propofol: 9-15 mg/kg/h
15981584|NCT03024827|Drug|CanniMed® 1:20|A cannabidiol (CBD): tetrahydrocannabinol (Δ9 THC) 20:1 ratio product will be provided as an oil-based suspension.
15981585|NCT03024814|Drug|Acetaminophen|"The first group will receive acetaminophen as the following
~Loading dose: 20 mg/kg in the first 12-24 hours To be diluted in D5W up to 3-5 ml and to be infused over 15 minutes.
~Maintenance dose: 7.5 mg/kg after 6 hrs from the loading dose and to be repeat every 6 hours for 3 days."
15981586|NCT03024814|Drug|Dextrose 5|"The second group will receive placebo (D5W) as the following
~Loading dose: 3-5 ml in the first 12-24 hours To be infused over 15 minutes.
~Maintenance dose: 3-5 ml after 6 hrs from the loading dose and to be repeat every 6 hours for 3 days."
15981587|NCT03024801|Drug|autologous platelet-rich plasma|The patients with knee cartilage injury were randomized to the intra-articular injection of autologous platelet-rich plasma group.
15981588|NCT03024801|Drug|normal saline|The patients with knee cartilage injury were randomized to the normal saline group.
15981589|NCT03024788|Device|syringe, fundus camera etc|Physical examination, fundus examination, blood and urine samples collection
15981590|NCT03024775|Dietary Supplement|Wheat flour|Wheat flour will be administered three times per day for 15 days.
15981591|NCT03024775|Dietary Supplement|Placebo|Placebo (xylose) will be administered three times per day for 15 days.
15981592|NCT03024762|Procedure|targeted Provider-Initiated-Testing and Counseling (tPITC)|The intervention arm involves children and adolescents with unknown HIV status, aged between 6 weeks to 19 years, born to parents living with HIV/AIDS. These children will be identified for HIV testing through their parents diagnosed with HIV or receiving HIV care in the hospital.
15981593|NCT03024736|Other|buprenorphin|"if buprenorphine has better neonatal outcomes compared to methadone in
~the treatment of opioid-maintained pregnant women"
15981594|NCT03024723|Device|nasal mask CPAP|CPAP and ventilation administered via nasal mask
15981595|NCT03024710|Behavioral|Intervention cluster|The mother- infant pairs (the infant who has completed his/her 6 month of age from the date of birth along with their mother) of intervention clusters will receive the CF practice counselling in groups as soon as enrolment is completed by CHRW at fixed site clinic and refreshers will be arranged 3 months apart from first training in groups at same place and by same person. However CHRWs will also counsel each participant during her bimonthly household visit.
15981596|NCT03024697|Procedure|Pectoral Plane Block|
15981597|NCT03024697|Procedure|Local Anaesthetic Wound Infusion Catheter|Levobupivicaine 0.1% @10ml/hr via a wound infusion catheter
15981598|NCT03024684|Drug|Atorvastatin|Atorvastatin 10mg daily
15981599|NCT03024684|Drug|Placebo Oral Tablet|Placebo one tablet daily
15981600|NCT03024671|Other|Patch test application|test patch with cosmetic product will be applied to the back
15981601|NCT03024658|Other|positive end expiratory pressure (PEEP)|Positive end expiratory pressure was applied using anesthesia machine at the time of induction in the patients undergoing laparoscopic bariatric surgery
15981602|NCT03024645|Behavioral|Be A Mom|The Be a Mom program is a web-based self-guided cognitive-behavioral intervention to prevent postpartum depression, targeting postpartum women. It consists of 5 weekly modules, each module targeting a specific thematic content, and providing women with both information and specific therapeutic strategies (with a strong focus on cognitive-behavioral techniques) to address each thematic content. Modules are sequential.
15981603|NCT03024645|Other|Treatment as usually (TAU)|performed in primary care settings
15981604|NCT03024632|Procedure|Trial of labor|trial of labor after 3 or more previous cesarean deliveries
15981605|NCT03024619|Other|Pain and Urinary pH|assess the correlation between urinary pH and Interstitial Cystitis (IC) pain, with emphasis placed on exploring the type and severity of pain
15981606|NCT03024606|Behavioral|text messages focused on smoking cessation and pregnancy|The impact of a text-message service on smoking cessation in medically underserved, obstetric patients when added to the usual care of pharmacist-driven CBT smoking cessation program and smoking cessation pharmacotherapy with either the nicotine replacement patch or bupropion.
15981607|NCT03024593|Behavioral|Health- and illness-related internet use|
15981608|NCT03024580|Drug|Megestrol Acetate 160Mg Tablet|Megestrol acetate 160 mg PO daily
15981610|NCT03024580|Drug|Letrozole 2.5Mg Tablet|Letrozole 2.5 mg PO daily OR
15981611|NCT03024580|Drug|Exemestane 25 MG|Exemestane 25 mg PO daily
15981612|NCT03024580|Drug|Tamoxifen 20Mg Tablet|Tamoxifen 20 mg PO daily
15981613|NCT03024580|Drug|Fulvestrant 50Mg Solution for Injection|Fulvestrant 500 mg IM d1, d14, d28 and q28 days
15981614|NCT03024567|Dietary Supplement|Salt|10 capsules daily for 14 days
15981615|NCT03024567|Dietary Supplement|Placebo|10 capsules daily for 14 days
15981616|NCT03024554|Device|Implantation of the Bifurcated Multilayer Flow Modulator|
15981617|NCT03024528|Behavioral|CPOT assessment|Polish version of Critical care pain observation tool validation.
15981618|NCT03024515|Drug|opioids titration|Standard Practice Arm
15981619|NCT03024515|Drug|predefined titration steps|comprising of oxycodone immediate release (OXYNORM) and oxycodone sustained release (OXYCONTIN) in pre-defined doses and frequencies
15981620|NCT03024502|Drug|EPP-AF Gel 1%|Administration intravaginal of EPP-AG Gel 1%, 1x/day, 7 days
15981621|NCT03024502|Drug|EPP-AF Gel 2%|Administration intravaginal of EPP-AG Gel 1%, 1x/day, 7 days
15981622|NCT03024502|Drug|Clotrimazole|Administration intravaginal of clotrimazol, 1x/day, 7 days
15981623|NCT03024489|Drug|Palbociclib|Dose Level -1: 100 mg oral every other day 3 week-on and 1-week of during IMRT (Day 1-21 and Day 29-49).
15981624|NCT03024489|Drug|Palbociclib|Dose Level 1: 75 mg per oral daily 3 week-on and 1-week of during IMRT (Day 1-21 and Day 29-49).
15981625|NCT03024489|Drug|Palbociclib|Dose Level 2: 100 mg per oral daily 3 week-on and 1-week of during IMRT (Day 1-21 and Day 29-49).
15981626|NCT03024489|Drug|Palbociclib|Dose Level 3: 125 mg per oral daily 3 week-on and 1-week of during IMRT (Day 1-21 and Day 29-49).
15981627|NCT03024489|Drug|Cetuximab|All dose levels: 400 mg/m2 IV at 7 days before (day -7) starting radiation and then 250 mg/m2 IV weekly for 7 weeks.
15981628|NCT03024489|Radiation|Intensity Modulated Radiation Therapy|5 days on/2 days off with a total dose of 70 Gy for 33-35 fractions.
15981629|NCT03024476|Behavioral|Behavioral intensification|"Suggested algorithm for behavioral intensification:
~If frequency of BP measurement ≤5 in a week, send a texting message
~If frequency of BP measurement ≤3 in a week, make a telephone contact by research nurse
~Target range of home-systolic blood pressure: 110 - 135
~If rate of outlier exceeds 50% in a week (based on ≥5 measurements in a week), make a telephone contact by research nurse (applied at least 2 weeks after randomization). A call for breakthrough visit may be issued when clinically required (decided by the institutional investigator)
~If frequency of BP measurement ≥ 10 in a week and frequency of outlier = 0 in a week, send a texting message to encourage and compliment on excellent BP management"
15981630|NCT03024476|Drug|Pharmacological intensification based on olmesartan|"Study drug will be provided from the roll-in period.
~Step I:
~Use olmesartan 20 mg only if mean systolic blood pressure ≤150 mm Hg during the immediate past 2 days
~Use olmesartan 40 mg if mean systolic blood pressure >150 during the immediate past 2 days
~Step II: olmesartan 20 mg or 40 mg + amlodipine 5 mg
~Step III: olmesartan 20 mg or 40 mg + amlodipine 10 mg
~Step IV: olmesartan 20 mg or 40 mg + amlodipine 10 mg + hydrochlorothiazide 12.5 mg
~If blood pressure profile showed high degree variability to evoke clinical concern, consider discontinuation of hydrochlorothiazide or reduction of olmesartan dose.
~Use of beta-blockers is permitted if clinically indicated.
~At each clinic visit regardless of regular or breakthrough visit, follow the pharmacological intensification rule."
15981631|NCT03024476|Device|Bluetooth-equipped sphygmomanometer|"Participants will be given a wireless Bluetooth-equipped sphygmomanometer system, which is connected to the main server through the participants' own smartphone. (Identical for both intervention and control groups)
~Every blood pressure and heart rate measured will be encrypted and stored in the main server. (Identical for both intervention and control groups)"
15981632|NCT03024463|Procedure|IM-SLNB and IMLN dissection|Internal mammary sentinel lymph node biopsy followed by internal mammary lymph node dissection
15981633|NCT03024450|Drug|H+CT|All patients were treated with trastuzumab plus chemotherapy as the first-line therapy. There were no protocol-specified chemotherapy regimens. This is a prospective observational study. Efficacy and safety of trastuzumab were analyzed, clinical and pathological data were collected to evaluate the potential prognostic factors on progressive free survival.
15981634|NCT03024437|Drug|Atezolizumab|Atezolizumab will be given intravenously every 3 weeks at 1200 mg.
15981635|NCT03024437|Drug|Bevacizumab|Bevacizumab will be given intravenously every 3 weeks at 15 mg/kg.
15981636|NCT03024437|Drug|Entinostat|Entinostat will be given orally every 7 days at 1, 3, or 5 mg depending upon phase. In Phase I, dose levels will be tested in up to 3 cohorts starting at 1 mg. In Phase II, the dose will be the recommended phase II dose that was determined during Phase I (i.e., 1, 3, or 5 mg).
15981637|NCT03024424|Behavioral|Early disclosure|
15981638|NCT03024424|Behavioral|Late disclosure|
15981639|NCT03024411|Other|iPod (Music/video games)|Experimental patients will be given an iPod to enjoy music/video games during induction of labor.
15981640|NCT03024385|Behavioral|Well Child Visits|Mothers of young infants will be screened for maternal behaviors that affect the outcome of future pregnancies. These behaviors are related to the following: family planning; smoking status, prenatal vitamin use and maternal depression. Mothers with positive screens will be offered appropriate resources. This will all take place during the child's routine well-child visit.
15981641|NCT03024372|Device|AV Fistula creation with sutures|End-to-side anastomosis (of AV fistula) is to be constructed using sutures. The incision is to be irrigated and closed using Vicryl, Biosyn and skin glue.
15981642|NCT03024372|Device|AV Fistula creation with clips|End-to-side anastomosis (of AV fistula) is to be constructed using clips. The incision is to be irrigated and closed using Vicryl, Biosyn and skin glue.
15981643|NCT03024359|Dietary Supplement|Extra virgin olive oil|2 liters of extra virgin olive oil will be given to participants to include/use in their daily foods.
15981685|NCT03024008|Biological|BonoFill-II|"Surgery will be performed under local or general anesthetics according to the Investigator's and anesthesiologist discretion.
~A standard orthopedic approach will be made according to the fracture site.Then the transplantation of BonoFill-II into the fracture site and the fixation of the fracture by intramedullary nail or plate and screws or external fixator as required will be performed.
~internal fixation (plate and screws and intramedullary nails) will not be routinely removed. External fixators will be removed upon achievement of satisfactory bone union."
15981644|NCT03024320|Behavioral|M2M|An eHealth platform has been designed to deliver a home-based package using the extensive set of movement patterns that have been adapted for people with a range of physical/mobility disability, called Movement-To-Music (M2M). The M2M prescription will be based on the participant's baseline level of health, function and fitness. Each movement pattern will be available in three different positions - standing, standing with support (chair) and seated. The duration of each M2M session will be gradually increased during the Adoption phase from three 20-minute sessions (10 min. aerobic & 10 min. strength) during weeks 1 to 3 (60 min/wk), to 45-min sessions (30 min. aerobic & 15 min. strength) during weeks 4 to 6 (135 min/wk), and to 50-min sessions (150 min/week) during weeks 7 to 12 (excluding 5-min warmup and 5-min cool down).
15981645|NCT03024320|Behavioral|Attention Control|Telecoaching on health-based topics, not including physical activity.
15981646|NCT03024307|Other|pharmacists involved OPCSP|This was an open labelled randomised study. Rheumatic diseases patients were recruited and arbitrarily divided into the intervention group (usual care plus OPCSP) and the non-intervention group (usual care only). Those enrolled in the research were scheduled for follow-up for eight consecutive visits. Improvements in lab results and direct costs were compared longitudinally (pre and post analysis) between the groups.
15981647|NCT03024294|Other|Post-operative care pathway for patients undergoing VATS lobectomy or segmentectomy|To place participants on this specific post-operative care pathway upon the completion of their VATS surgery to determine the discharge rate by midnight on post-operative day (POD) three.
15981648|NCT03024268|Device|Figulla Flex Occluder (Occlutech)|Interventional closure of the iASD with an Figulla Flex Occluder (Occlutech)
15981649|NCT03024255|Drug|BBI-4000 Concentration 1|Lowest test dose
15981650|NCT03024255|Drug|BBI-4000 Concentration 2|Test dose between high and low concentrations
15981651|NCT03024255|Drug|BBI-4000 Concentration 3|Highest test dose
15981652|NCT03024255|Drug|Vehicle (Placebo)|Vehicle without drug
15981653|NCT03024242|Device|Tight vaginoscope|
15981654|NCT03024229|Device|LifePort® perfusion machine|Renal perfusion on LifePort® machine
15981655|NCT03024216|Drug|Atezolizumab1200 mg IV|Subjects in ARM 1 will receive 2 doses of atezolizumab 1200 mg intravenously (week 1 and week 4). If no dose limiting toxicity continue onto maintenance, week 13 and receive atezolizumab 1200 mg intravenously every 3 weeks until toxicities or lack of clinical benefit. Subjects in ARM 2 will receive 2 doses at approximately 3 weeks each of atezolizumab 1200 mg intravenously (weeks 7 and 10). If no dose limiting toxicity, continue to receive atezolizumab 1200 mg intravenously every 3 weeks, starting week 13, until toxicities or lack of clinical benefit.
15981656|NCT03024216|Drug|Sipuleucel-T|Subjects in ARM 1 will receive sipuleucel-T administered in 3 doses at approximately 2-week intervals (weeks 6, 8, 10). Subjects in ARM 2 will receive sipuleucel-T administered in 3 doses at approximately 2-week intervals (weeks 1, 3 and 5)
15981657|NCT03024203|Behavioral|Cognitive Remediation - Executive Training|Cognitive remediation is a cognitive and behavioural therapy designed to improve cognitive skills such as memory, and problem solving ability.
15981658|NCT03024203|Behavioral|Cognitive Remediation - Perceptual Training|Cognitive remediation is a cognitive and behavioural therapy designed to improve cognitive skills such as attention, and processing speed.
15981659|NCT03024190|Other|Kinesiotaping|The technique of Kinesiotaping for spastic wrists and fingers in stroke patients is performed from the proximal interphalangeal joints of all fingers acted on the extensor carpal and digital muscle groups, with an anchor at the proximal one-third forearm.
15981660|NCT03024190|Other|stretching exercise|15- min stretching exercise for upper extremity twice daily
15981661|NCT03024190|Other|OT rehabilitation program|regular rehabilitation program for 3 weeks
15981662|NCT03024177|Drug|Vapendavir|Vapendavir Tablets, 264 mg
15981663|NCT03024177|Drug|Placebo Oral Tablet|Vapendavir 264 mg matching tablets
15981664|NCT03024164|Other|Treatment following current guidelines|Treatment following current guidelines
15981665|NCT03024151|Drug|Comthyroid|T4/T3 combination replacement
15981666|NCT03024151|Drug|Synthroid|T4 mono replacement
15981667|NCT03024138|Radiation|Repeat CT scan|
15981668|NCT03024125|Other|High protein|To observe the effect of a high protein (HP) diet over muscle mass, fat mass, and strength changes, focusing in differences between the NP and HP groups.
15981669|NCT03024125|Other|Normal protein|To observe the effect of a normal protein (NP) diet over muscle mass, fat mass, and strength changes
15981670|NCT03024125|Other|Training|The physical strength training will be performed equally by both groups, containing exercises for upper and lower limbs and aiming for hypertrophy.
15981671|NCT03024112|Device|Heated humified high-flow nasal cannula Oxygen|
15981672|NCT03024112|Other|Standard oxygen therapy|
15981673|NCT03024099|Other|Hippotherapy once a week|Hippotherapy once a week
15981674|NCT03024099|Other|Hippotherapy twice a week|Hippotherapy twice a week
15981675|NCT03024086|Drug|DWJ1252|DWJ1252 and Placebo of Gasmotin
15981676|NCT03024086|Drug|Gasmotin|Gasmotin and Placebo of DWJ1252
15981677|NCT03024073|Procedure|BB-Phaco|Phacoemulsification with bilateral bifocal lenses implantation
15981678|NCT03024060|Drug|ALA|20% ALA applied to 4-15 lesions on the face or scalp 14-18 hours prior to 10 J/cm2 blue light
15981679|NCT03024060|Drug|Vehicle|Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to 4-15 lesions on the face or scalp 14-18 hours prior to 10 J/cm2 blue light
15981680|NCT03024060|Device|IBL 20 mW|10 J/cm2 blue light delivered at 20mW/cm2 for 8 minutes 20 seconds
15981681|NCT03024060|Device|IBL 10 mW|10 J/cm2 blue light delivered at 10mW/cm2 for 16 minutes 40 seconds
15981682|NCT03024047|Device|Pacemaker|
15981683|NCT03024034|Drug|TP-271|single oral dose of TP 271 or placebo, randomized 3:1, doses escalating as 25 mg, 50 mg, 100 mg, 150 mg, 200 mg, and 300 mg, and a final crossover cohort of 50 mg TP-271 and 50 mg TP-271 with 250 mg of EDTA, or placebo and 250 mg of EDTA
15981684|NCT03024021|Device|Near-infrared spectroscopy (NIRS) (INVOS®, Covidien)|As we start the targeted temperature management protocol (24 hours of hypothermia adjusted to 33-36 C and afterwards up to five days of normothermia [36.5 C]) NIRS sensor pads will be placed over the right and left frontal area. Regional cerebral oxygen values will be continuously recorded at the NIRS monitor. Tests to assess neurological outcome will be performed. Patients will be assessed in terms of neurological performance tests and regional cerebral oxygen.
15981686|NCT03023995|Procedure|CAF with Platelet rich fibrin|In test group, preparation of PRF was carried out, after which the flap was coronally positioned over the membrane to completely cover it and secured with 4-0 non resorbable sutures.
15981687|NCT03023995|Procedure|CAF with connective tissue graft|In control group, connective tissue graft was harvested, after which the flap was coronally positioned over the graft to completely cover it and secured with 4-0 non resorbable.
15981688|NCT03023982|Drug|Bupivacaine Hydrochloride|40 cc 0.25% of Bupivacaine Hydrochloride injection using ultrasound approach will be administered between pectoralis minor and serratus anterior muscle at the 3rd and 4th rib
15981689|NCT03023982|Device|Ultrasound|All blocks will be done under ultrasound
15981690|NCT03023982|Procedure|Thoracotomy|The patient population will include patients that undergo either open thoracotomy or thoracoscopy for anatomic and non-anatomic lung resection. The standard thoracoscopy approach in our institute includes three holes technic. There are two incisions of 1 cm and utility incision of 4 cm. The standard thoracotomy is posterior- lateral thoracotomy which divided the latissimus dorsi muscle but spears the serratus anterior muscle.
15981691|NCT03023982|Drug|Opioids|standard pain control with opioids
15981692|NCT03023982|Drug|NSAID|standard pain control with NSAIDs
15981693|NCT03023969|Drug|ozone oxygen mixture|receive 10 ml of ozone oxygen mixture under variable dosing
15981694|NCT03023956|Procedure|Locking plates were used for proximal humeral fractures.|
15981695|NCT03023943|Other|Instrument Assisted Soft Tissue Mobilization|Intervention will be 10 minutes of GT1 instrument application at anterior thigh using sweep technique.
15981696|NCT03023930|Other|Standard Dissemination Practice|Emergency department provider education using a grand rounds format. The content of the lecture will cover the scope of the opioid problem, ED specific facts related to the epidemic, potential models of intervention including the results of publications outlining the efficacy of ED-initiated BUP.
15981697|NCT03023930|Other|Implementation Facilitation (IF)|"IF involves a formative evaluation to identify the specific and dynamic needs of stakeholders and the context for implementation of evidence-based practices. This evaluation informs the initial tailoring and refinement of the IF, which includes a bundle of services tailored to meet site-specific needs, such as identifying and engaging local stakeholders, providing extensive ongoing education, tailoring program to the site and monitoring performance and offering feedback."
15981698|NCT03023917|Procedure|umbilical cord milking|Infants were placed at or below level of the placenta and about 25cm of the umbilical cord was vigorously milked towards the umbilicus two to three times before clamping the cord. The milking speed was about 25cm/2 seconds
15981699|NCT03023917|Procedure|umbilical cord clamping immediately|umbilical cord was cut immediately after birth
15981700|NCT03023904|Biological|Nivolumab|Given IV
15981701|NCT03023904|Other|Laboratory Biomarker Analysis|Correlative studies
15981702|NCT03023891|Drug|Prednisone|Prednisone 60 mg tablet once
15981703|NCT03023878|Drug|Blinatumomab|Blinatumomab monotherapy was supplied in single-use sterile glass injection vials and administered as an IV infusion.
15981704|NCT03023878|Drug|Investigator's Choice Chemotherapy|"During the run-in period participants received 6 cycles of standard of care rituximab-chemotherapy dosed per investigator's institution standard as follows:
~R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine,prednisone)
~R-DA-EPOCH (rituximab and dose adjusted-etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin) or
~R-CHOEP (rituximab and cyclophosphamide, doxorubicin, vincristine, prednisone, and etoposide)."
15981705|NCT03023878|Drug|Dexamethasone|Dexamethasone 20 mg IV: within 1 hour prior to start of treatment in each treatment cycle, and within 1 hour prior to dose-step (increase).
15981706|NCT03023865|Procedure|Staged stress function|A preoperative staged stress function procedure for elongation of the proximal and distal segments to achieve utilizing the native esophagus to establish esophageal continuity
15981707|NCT03023852|Drug|JNJ-63623872|Participants will receive JNJ-63623872 600 mg (2*300 mg) oral tablets in Panel 1 and 2 under Fasted conditions.
15981708|NCT03023852|Drug|Oseltamivir|Participants will receive Oseltamivir 75 mg (1*75 mg) oral capsule (reference) in Treatment D of Panel 2 and Oseltamivir 75 mg administered as JNJ-63623872/37.5 mg Oseltamivir oral FDC tablet concept formulation (test 3) in Treatment E of Panel 2.
15981709|NCT03023826|Drug|LY3202626 (R-Fasting)|Administered orally
15981710|NCT03023826|Drug|LY3202626 (T1-Fasting)|Administered orally
15981711|NCT03023826|Drug|LY3202626 (T1-Fed)|Administered orally
15981712|NCT03023813|Other|Intervention|Written material provided.
15981713|NCT03023800|Procedure|Macular buckling|Surgical procedures of macular buckling, drainage of aqueous fluid (0.1-0.2 ml) through limbal paracentesis, and inject gas ( C3F8 100%, 0.2ml-0.3ml) into vitreous body through pars plana, under systemic anesthesia.
15981714|NCT03023800|Procedure|Vitrectomy|Surgical procedures of small gauge vitrectomy, internal limiting membrane peeling, and gas (C3F8, 14%) tamponage, under local or systemic anesthesia
15981715|NCT03023787|Drug|Hepalatide|There are three cohorts as follows 4.2mg, 6.3mg, 8.4mg. At each dose level, healthy volunteers will be received treatment drug by abdominal subcutaneous injection once a day for seven days and will be monitored for 3 days.
15981716|NCT03023787|Drug|Placebo|There are three cohorts as follows 4.2mg, 6.3mg, 8.4mg. At each dose level, healthy volunteers will be received control drug by abdominal subcutaneous injection once a day for seven days and will be monitored for 3 days.
15981717|NCT03023774|Drug|Neupogen|neupogen 30 IU once intrauterine at the time of ovum pickup
15981718|NCT03023761|Device|low level laser|low level laser irradiation
15981719|NCT03023761|Device|laser sham|laser without irradiation
15981720|NCT03023748|Drug|Intravenous Paricalcitol|Twenty four months of intravenous paricalcitol will be given twice or thrice weekly post-hemodialysis depending on frequency of hemodialysis of the patients
15981721|NCT03023735|Other|None. This is an observational study|
15981723|NCT03023709|Biological|Fluzone®|quadrivalent, inactivated influenza virus vaccine, intramuscular
15981724|NCT03023709|Biological|FluMist®|quadrivalent, live, attenuated influenza vaccine, intranasal spray
15981762|NCT03023423|Drug|Atezolizumab|Participants will receive atezolizumab 1200 mg intravenously.
15981725|NCT03023696|Procedure|Bilateral Cervical Keyhole Foraminotomy|Under microscopic or loop magnification, a high-speed burr is used to perform the foraminotomy. The keyhole foraminotomy begins at the lamina-facet junction, with careful consideration of the amount of facet resection. Typically, only the medial one third is drilled. Then a 1- or 2-mm Kerrison punch can be carefully placed over the nerve root and then used to undercut the facet, ensuring that the spine is not destabilized by the foraminotomy. The amount of facet resection must not exceed 50% in order to preserve spine stability.
15981726|NCT03023696|Procedure|Cervical Decompression|Cervical decompression for myelopathy, including the following procedures: laminoplasty, laminectomy, discectomy and fusion
15981728|NCT03023670|Procedure|cardiopulmonary bypass|Low flow of mixed oxygen / air (1:1L) will be used during the period of cardiopulmonary bypass
15981729|NCT03023670|Procedure|cardiopulmonary bypass|Low rate (4\min) with low tidal volume ( 2ml/kg ) will be used during the period of cardiopulmonary bypass.
15981730|NCT03023657|Other|Detection of arousal|Detecting facial microexpression before visible facial expressions in patient with disorder of consciousness after severe brain injury
15981731|NCT03023644|Behavioral|Cogmed Working Memory Training|Cogmed Working Memory Program will be used as a computerized home-based intervention. Families will an iPad with a web-based software program. The 25 sessions will be completed individually by the child with parental supervision. For the first 5 sessions, the participant trains on the same set of games; on the 6th session and every 5th session thereafter, a new task is introduced and replaces one of the initial tasks. At the end of each session, the child can play an age-appropriate computerized game as a reward. After each session, results are uploaded by parents to a secure website, to keep track of the participant's progress. Families will be contacted weekly to check program function and discuss concerns.
15981732|NCT03023631|Biological|Recombinant Human Papillomavirus Nonavalent Vaccine|Given IM
15981733|NCT03023618|Device|FloTrac|Stroke Volume has been maintained at 90% of the maximal Stroke Volume as in NICE protocol 2011
15981734|NCT03023605|Behavioral|Training Intervention for PE Diagnosis|"Focused on the Emergency Department staff and the rotating residents during the months 4 and 5 of 2015, and consisted of:
~Clinical Update Sessions for staff ED (20 physicians)
~training sessions for residents that rotate in ED (60 physicians )
~Development of a triptych, including clinical prediction scales, combination algorithm of scales and D-Dimmer value
~Development of posters, with brief information
~Dissemination by e-mail of scientific information
~Direct reminder during the working day"
15981735|NCT03023592|Drug|Iguratimod|Iguratimod 25 mg orally twice a day for 24 weeks
15981736|NCT03023579|Other|The star excursion balance test|
15981737|NCT03023566|Drug|Dotarem|Dotarem at dose of 0.1 mmol/kg of body weight (routine/standard of care)
15981738|NCT03023553|Biological|Fluzone®|Influenza Virus Vaccine Suspension for Intramuscular Injection
15981739|NCT03023553|Biological|FluMist®|Influenza Virus Vaccine Live, Intranasal Spray
15981740|NCT03023540|Drug|PXT3003|Liquid oral solution, 5 mL (Dose 1 or Dose 2) bid OR 10 mL (Dose 1) bid
15981741|NCT03023527|Drug|Nivolumab|
15981742|NCT03023527|Drug|Pomalidomide|
15981743|NCT03023527|Drug|Dexamethasone|
15981744|NCT03023527|Drug|Elotuzumab|
15981745|NCT03023514|Dietary Supplement|Oral Lipoic acid|300 mg ALA x2 (1pill orally/12h) to the recipient from the day of the donors pick up until 8 week of pregnancy
15981746|NCT03023514|Drug|Vaginal Progesterone|200 mg Vaginal Progesterone (1 vaginal capsule/24h) from the day of the donors pick up until 8 week of pregnancy
15981747|NCT03023501|Drug|Gabapentin|
15981748|NCT03023501|Drug|Placebo Oral Capsule|
15981749|NCT03023488|Procedure|flexible ureteroscopy|Flexible ureteroscopy is an endourological procedure performed for kidney stones. The flexible ureteroscope is a device used to reach the renal cavities through the natural urinary tract in a retrograde fashion. During the operation, irrigation fluid is used to expand the cavities to provide space for movement of the device and also to provide clear vision.
15981750|NCT03023488|Device|Doppler Ultrasound examination|peak systolic velocities (PSV) and end diastolic velocities (EDV) of the arteries will be measured and then resistive index (RI) and pulsatility index (PI) will be calculated.
15981751|NCT03023488|Device|laser lithotripsy|The laser fiber extending into the cavities through the working channel of the ureteroscope is used to fragment the stones. Laser energy is generated by the laser machine and transmitted to the stones via the laser fiber.
15981752|NCT03023475|Device|LigaSure endoscopic vessel harvesting|The radial artery will be harvested endoscopically using the LigaSure system.
15981753|NCT03023475|Device|TLS2 endoscopic vessel harvesting|The radial artery will be harvested endoscopically using the TLS2 system.
15981754|NCT03023462|Drug|Oksykodonhydroklorid|Oksykodonhydroklorid, 5 - 10 mg intravenously or orally postoperatively to reduce pain. Repetition until effect.
15981755|NCT03023462|Drug|Ondansetron and Droperidol|When nausea and vomiting: Ondansetron 4mg and droperidol 0,625 mg intravenously
15981756|NCT03023462|Drug|Ropivacaine|Local anesthetic for the block
15981757|NCT03023449|Drug|Nitric Oxide|Inhaled Nitric Oxide gas
15981758|NCT03023436|Procedure|Cytoreductive surgery|"Gastrectomy with D2 lymph node dissection and Metastasectomy for peritoneal metastatic sites only.
~A total, distal, or proximal gastrectomy and the type of reconstruction will be selected according to the surgeon's experience.
~Metastasectomy is limited to peritoneal metastatic sites only to render the patient no evidence of disease (NED) with at least 1cm negative margins when possible."
15981759|NCT03023436|Procedure|Hyperthermic Intraperitoneal Chemotherapy|Docetaxel 120 mg diluted in 5.0 L of saline is forced into the abdomen through the inflow catheter by a pump and pulled out through the drains as a heated intraperitoneal perfusion.A heat exchanger keeps the intraperitoneal fluid at 43±0.5℃ and duration limited to 70 minutes.24 hours after cytoreductive surgery no less than 2 cycles postoperative chemotherapy will be recommended.
15981760|NCT03023436|Drug|Fluoropyrimidine|CF regimens or other first line regimens based on Fluoropyrimidine and Platinum according to the NCCN Guidelines（Gastric Cancer，version 3.2016) are recommended.Regimens and dosing schedules are not limited in this trial.
15981761|NCT03023436|Drug|Cisplatin|CF regimens or other first line regimens based on Fluoropyrimidine and Platinum according to the NCCN Guidelines（Gastric Cancer，version 3.2016) are recommended.Regimens and dosing schedules are not limited in this trial.
15981763|NCT03023423|Drug|Daratumumab|Participants will receive daratumumab 16 mg/kg intravenously.
15981764|NCT03023410|Procedure|VERASENSE|Sensor-Assisted Revision TKA
15981765|NCT03023397|Biological|Der f|Nasal administration of Dermatophagoides farinae with 100 allergen units (AU), 500 AU, and finally 1000 AU
15981766|NCT03023358|Drug|chidamide|30mg po twice a week
15981767|NCT03023358|Drug|cyclophosphamide|750mg/m2 iv on day 1
15981768|NCT03023358|Drug|liposomal doxorubicin|30mg/m2 iv on day 1
15981769|NCT03023358|Drug|vincristine|1.4mg/m2 iv on day 1
15981770|NCT03023358|Drug|prednisone|100mg/d po on day 1-5
15981771|NCT03023345|Device|Microwave trans rectal focal treatment|Microwave trans-rectal ablation of the prostatic index tumor using MRI-transrectal ultrasound image registration
15981772|NCT03023332|Behavioral|Resourcefulness Training|A cognitive-behavioral intervention delivered through iPad technology that consists of teaching and reinforcing personal (self-help) and social (help-seeking) resourcefulness skills.
15981773|NCT03023332|Behavioral|Biofeedback training|"Use of a heart-rate variability (HRV) tracking device to enable one to learn to alter physiology to improve health. Devices are used to measure physiological activity, e.g., breathing and heart function, and provide rapid, accurate feedback to the user, thereby enabling desired physiological changes that can endure over time without continued use of the device and continue to influence behavior."
15981774|NCT03023332|Behavioral|Bipolar Education|An educational program designed to teach family caregivers of about the types, causes, symptoms, episodes, warning signs, and treatments for individuals with bipolar disorder, as well as available resources for assisting a family member with bipolar disorder. The content to be presented within an audiovisual format using iPad technology follows the recommendations and guidelines developed through research and by the Depression and Bipolar Support Alliance and the National Institute of Mental Health.
15981775|NCT03023319|Drug|Bosutinib|100mg daily for 4 cycles (21 days per cycle)
15981776|NCT03023319|Drug|Pemetrexed|500 mg/m2 every 21 days for 4 cycles
15981777|NCT03023306|Other|Antiemetics perioperatively|Preemptive group ondansetron 4 mg will be administered 1h before surgery Intraoperative group Ondansetron 4 mg will be administered intraoperatively
15981778|NCT03023293|Other|n-3 PUFAs consumption and irisin|The investigators plan to collect n-3 PUFAs and irisin information at 24-28 weeks' gestation, 42 days postpartum, 1 year postpartum and 2 years postpartum
15981779|NCT03023280|Procedure|Radiofrequency ablation|
15981780|NCT03023267|Behavioral|Music therapy and Kangaroo care|Mother holding baby in skin to skin position while singing
15981781|NCT03023267|Behavioral|Kangaroo Care alone|Mother holding baby in skin to skin position without singing
15981782|NCT03023254|Other|Hydrotherapy|3-week Avène hydrotherapy
15981783|NCT03023241|Procedure|biopsy|cold cup bladder biopsies and bladder washings under anesthesia, blood and urine collection
15981784|NCT03023228|Behavioral|diabetes self-management education|1-group, pre-test/post-test design feasibility and preliminary efficacy evaluation of diabetes survival skills self-management education delivered at the hospital bedside.
15981785|NCT03023215|Procedure|Meditation|Participants guided through 10 minutes of intervention by a mind-body specialist who will follow a standardized script prior to stereotactic breast biopsy (SBB). Mind-body specialist will also accompany participant during SBB to continue intervention.
15981786|NCT03023215|Procedure|Electroencephalogram|Electroencephalogram (EEG) activity recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB.
15981787|NCT03023215|Behavioral|Questionnaires|Self-report measures (anxiety and pain) assessed at baseline, immediately before, during, and after the SBB.
15981788|NCT03023215|Procedure|Heart Rate|Heart rate (HR) recorded at baseline, for 10 minutes prior to the SBB, throughout the SBB, and immediately following SBB.
15981789|NCT03023202|Other|PMMTB (Precision Medicine Molecular Tumor Board)|PMMTB is a clinical intervention, NOT a research intervention. The research component of this study is to observe the outcomes of the PMMTB.
15981790|NCT03023189|Drug|Tranexamic acid|"At randomisation : loading dose of 1g of intravenous tranexamic acid for 10 min, immediately followed by an intravenous infusion of 3g of TA over 24h.
~Total dose : 4 g of TA"
15981791|NCT03023189|Drug|Placebo|At randomisation : loading dose of 10 mL of intravenous isotonic saline for 10 min, immediately followed by an intravenous infusion of 30 mL of isotonic saline over 24h Total dose : 40 mL of Placebo
15981792|NCT03023176|Biological|Fluzone® standard IIV3|Influenza Virus Vaccine Suspension (0.5ml) for Intramuscular Injection
15981793|NCT03023176|Biological|Fluzone® standard IIV3 Pediatric Dose|Influenza Virus Vaccine Suspension (0.25ml) for Intramuscular Injection
15981794|NCT03023163|Other|Longitudinal|Participants that completed the Impact of Age on Cardiovascular, Cerebrovascular, Cerebrovascular and Cognitive Health study, will be re-assessed again to compare longitudinal (3-5 years) change in blood pressure, cerebral blood flow, arterial stiffness and cognitive health.
15981795|NCT03023150|Other|Ischemic Preconditioning|
15981796|NCT03023150|Other|Sham|
15981797|NCT03023137|Behavioral|Walking & dietary modification|"Daily walking at a moderate pace (4 km/h) > 40 min, 7/7. Those remaining seated most of the day should walk 25-30 min twice a day, avoiding >12 h of physical inactivity. Walking may be replaced by stationary bicycle rides or swimming when convenient, which often occurred near term and when the mother was obese.
~At least two daily servings of protein-rich food (≥ 4 g/kg of meat, poultry, fish or eggs) per day. Avoidance of high-carbohydrate, low-fiber meals, such as snacks, candies, fiber-free juices, coconut water or sugar-sweetened beverages. Sucralose could be used as a sweetener. Participants are recommended to use ondansetron for nausea and vomiting prevention"
15981798|NCT03023124|Drug|Trabectedin|Treatment with trabectedin repeated every 21 days for 6 cycles
15981799|NCT03023124|Drug|Adriamycin|Treatment with Adriamycin at day 1 every 21 days for 6 cycles
15981800|NCT03023124|Drug|Dacarbazine|Treatment with Dacarbazine at days 1 and 2 every 21 days for 6 cycles
15981801|NCT03023111|Drug|Sbv|Standard treatment for CL, parenteral drug used during 20 days.
15981802|NCT03023111|Drug|Miltefosine plus placebo|Oral treatment for CL, capsules with 50mg used 3 times a day, during 28 days. Placebo gel cream will be used topically.
15981803|NCT03023111|Drug|Miltefosine plus GM-CSF|Oral treatment for CL, capsules with 50mg used 3 times a day, during 28 days. GM-CSF gel cream will be used topically.
15981804|NCT03023098|Device|Conventional PTA|After passing the stenosis it is dilated with a conventional balloon. The patient is randomized to a second dilatation with a conventional balloon
15981805|NCT03023098|Device|Drug-eluting balloon|After passing the stenosis it is dilated with a conventional balloon. The patient is randomized to a second dilatation with a drug-eluting balloon
15981806|NCT03023085|Drug|BLI4700|BLI4700 bowel preparation
15981807|NCT03023072|Other|Incontinence Detection System|
15981808|NCT03023059|Drug|Carbidopa-Levodopa, 25 Mg-100 Mg Oral Tablet|See Arm description
15981809|NCT03023046|Drug|Cyclophosphamide|Given IV
15981810|NCT03023046|Drug|Dasatinib|Given PO
15981811|NCT03023046|Drug|Doxorubicin|Given IV
15981812|NCT03023046|Drug|Etoposide|Given IV
15981813|NCT03023046|Drug|Imatinib Mesylate|Given PO
15981814|NCT03023046|Other|Laboratory Biomarker Analysis|Correlative studies
15981815|NCT03023046|Drug|Prednisone|Given PO
15981816|NCT03023046|Biological|Rituximab|Given IV
15981817|NCT03023046|Drug|Vincristine Sulfate|Given IV
15981818|NCT03023033|Behavioral|mHealth messaging|SMS appointment reminders and health messaging via mobile phones
15981819|NCT03023033|Behavioral|Transport Payments|A payment scaled to reflect the cost of typical return transport fare for residents of the clinic catchment area
15981820|NCT03023020|Drug|Aspirin|Dosing per current guidelines and local practice
15981821|NCT03023020|Drug|P2Y12 inhibitor|Dosing per current guidelines and local practice
15981822|NCT03023007|Procedure|Loco-regional anaesthesia|Loco-regional anaesthesia
15981823|NCT03022994|Other|Duodenum and rectum examination|All subjects will undergo upper gastrointestinal endoscopy and proctoscopy. In addition, it will be also evaluated duodenal and rectal biopsies.
15981824|NCT03022981|Drug|SOF/VEL|SOF/VEL fixed-dose combination (FDC) 400/100 mg tablets or SOF/VEL FDC 200/50 mg tablets (based on swallowability assessment)
15981825|NCT03022981|Drug|SOF/VEL|SOF/VEL FDC 200/50 mg oral granules
15981826|NCT03022968|Drug|[18F]T807 PET|Imaging with [18F]T807 PET
15981827|NCT03022955|Dietary Supplement|Dark chocolate bar|Dark chocolate bar (70% cocoa solids (~500kcal, ~50% fat)), 100g / day for 3 days to assess postprandial brain activity and colonic transit by FDG-PET.
15981828|NCT03022955|Dietary Supplement|Dark chocolate mousse|Dark chocolate mousse (150g, ~500kcal, ~50% fat) to assess gastric emptying and oro-caecal transit time by scintigraphy.
15981829|NCT03022955|Dietary Supplement|White chocolate bar|White chocolate bar (0% cocoa solids (~500kcal, 50% fat)), 100g / day for 3 days to assess postprandial brain activity and colonic transit by FDG-PET.
15981830|NCT03022955|Dietary Supplement|White chocolate mousse|White chocolate mousse (150g, ~500kcal, ~50% fat) to assess gastric emptying and oro-caecal transit time by scintigraphy.
15981831|NCT03022942|Other|GROUP Costal mobilization & Diaphragm Release|Costal mobilization technique (Rib raising): The patient will be lying. The Therapist supports the last four pulps of both hands at the rib angles, gently traverses the rib angles in the posterior-anterior direction, using the stretcher as a lever to facilitate the elevation of the costal angles. Siting: The Therapist hugs the patient by supporting the ribs of the fingers at the rib angles, gently traverses the rib angles bilaterally in the anterior-lateral direction. Manual Diaphragm Release Technique: The therapist makes manual contact with the underside of the costal border of the common cartilage of the last rib. In the inspiratory phase, the therapist draws the points of contact with both hands in a cephalad direction and slightly Accompanying the movement of the rib cage.
15981832|NCT03022942|Other|GROUP Manual Diaphragm Release|The therapist makes manual contact with the underside of the costal border of the common cartilage of the last rib. In the inspiratory phase, the therapist draws the points of contact with both hands in a cephalad direction and slightly Accompanying the movement of the rib cage.
15981833|NCT03022929|Behavioral|Enhanced Antimicrobial Stewardship Commitment and Feedback|Goes beyond the GetSmart recommendations to discern whether these recommendations can be improved upon.
15981834|NCT03022916|Drug|Nail Polish + Efinaconazole Solution|Application of Jublia to the nail of one big toe on top of the nail polish
15981835|NCT03022916|Other|Nail polish|Application of nail polish only to both big toe nails
15981836|NCT03022916|Drug|Base Coat + Nail Polish + Top Coat + Efinaconazole Solution|Application of Jublia to the nail of one big toe on top of the nail polish with layers of top coat and base coat
15981837|NCT03022916|Drug|Nail Polish + Top Coat + Efinaconazole Solution|Application of Jublia to the nail of one big toe on top of the nail polish with layer of top coat
15981838|NCT03022903|Procedure|Aminolevulinic Acid (ALA)|Photosensitizing
15981839|NCT03022890|Behavioral|hatha yoga|12 weeks of hour-long gentle hatha yoga classes
15981840|NCT03022890|Behavioral|health education|12 weeks of hour-long classes on nutrition, sleep, coping with pain, and other health educaiton topics
15981841|NCT03022877|Drug|Levosimendan|In a prospective randomized setting, patients are included with an acute STEMI of the anterior wall. A bolus administration Levosimendan with/without following continuous infusion over 24 hours compared to a control group (placebo) will be examined. The initiation of therapy is carried out for 10 min. prior to reperfusion. The coronary Intervention is performed immediately after inclusion at the latest within 6 hours after the onset of symptoms. The administration of Levosimendan is based on a fixed schema: Bolus: 12 µg/kg over 10 min I. V., starting 10 min before recanalization and an addition of 0.1-0.2 µg/kg/min i. v. for 24 hours in the continuous infusion group.
15981842|NCT03022851|Device|Occlutech AFR Device|Catheter-guided transeptal placement of an AFR device following balloon atrial septostomy (BAS) -procedure.
15981843|NCT03022838|Drug|Caffeine|From the point of enrollment, patients will substitute their daily dietary caffeine with either placebo- or capsulated caffeine tablets (Recip®, 100mg).
15981844|NCT03022825|Drug|N-803 and BCG|BCG and N-803 will be mixed together (with saline) and administered via intravesical instillation weekly for 6 consecutive weeks (induction). After the first disease assessment, eligible patients will receive either a 3-week maintenance course or a 6-week re-induction course (second treatment period) at Month 3. Eligible patients will continue to receive maintenance treatment in the third treatment period at Months 6, 9, 12, and 18. Eligible patients will continue to receive maintenance treatment in the optional fourth treatment period at Months 24, 30 and 36.
15982096|NCT03020771|Biological|KIRIM-KONGO-VAX|Crimean-Congo Hemorrhagic Fever Vaccine
15982097|NCT03020771|Other|Placebo|
15981845|NCT03022825|Drug|N-803|N-803 will be administered via intravesical instillation weekly for 6 consecutive weeks (induction). After the first disease assessment, eligible patients will receive either a 3-week maintenance course or a 6-week re-induction course (second treatment period) at Month 3. Eligible patients will continue to receive maintenance treatment in the third treatment period at Months 6, 9, 12, and 18. Eligible patients will continue to receive maintenance treatment in the optional fourth treatment period at Months 24, 30 and 36.
15981846|NCT03022812|Other|Neck-specific exercise|Neck-specific exercise
15981847|NCT03022799|Drug|KM-819|
15981848|NCT03022799|Drug|Placebo|
15981849|NCT03022786|Other|Order set|Inpatient order set and ambulatory care guide offer guidance on initial compression to decrease edema, obtaining gradient compression stockings, how to access evaluation by vascular medicine for pain or dermatology for evaluation of allergic contact dermatitis if itch persists, etc
15981850|NCT03022786|Other|Motivational Interviewing training for home health aides|"Home Care aides trained about use of compression stockings and use of motivational interviewing as a tool to help patients make behavior changes to reduce leg swelling. This is part of our 'tool kit'.
~There will be a focus group comprised of providers. This focus group will explore the perceptions of the providers and what unmet needs remain for the patients."
15981851|NCT03022786|Other|Tools & Education|Engaged physical therapists to evaluate patients for ability to don stockings, to assess need for strengthening exercises or leg exercises to improve venous return. This is part of our 'tool kit'
15981852|NCT03022773|Other|Carotenoid measurements|"Carotenoid measurements of the eye (macula) are obtained through non-invasive ophthalmic photographs using the Heidelberg Spectralis imaging system.
~Carotenoid measurements of the skin are measured by a laboratory instrument that uses a painless blue laser light for exposure of the skin and a photodetector for scattered light.
~Carotenoid measurements in the blood are obtained through routine venipuncture."
15981853|NCT03022760|Behavioral|Work-related measures|After mapping the patient's psychosocial work situation using tools provided at the one-day training, the patient's employer will be contacted and involved in the rehabilitation planning.
15981854|NCT03022747|Drug|Allopurinol|Allopurinol is added to standard oral 6-mercaptopurine and methotrexate
15981855|NCT03022747|Drug|Standard treatment|Oral 6-mercaptopurine and methotrexate
15981856|NCT03022734|Drug|chemotherapy|cetuximab 250mg/m2 or bevacizumab 5mg/kg, FOLFOX (oxaliplatin 85mg/m2, leucovorin 200mg/m2, 5-FU 400mg/m2, 5-FU continuous 1200mg/m2) or FOLFIRI (irinotecan 180mg/m2, leucovorin 200mg/m2, 5-FU 400mg/m2, 5-FU continuous 1200mg/m2)
15981857|NCT03022734|Radiation|radiotherapy|After FOLFOX 4cycle, subject have short course radiotherapy 5Gy for 5 days.
15981858|NCT03022721|Other|No interventions are planned for this study.|No interventions are planned for this study, it is purely observational.
15981859|NCT03022708|Device|Xeltis Bioabsorbable Pulmonary Valved Conduit|Surgical implantation of Xeltis Bioabsorbable Pulmonary Valved Conduit
15981860|NCT03022695|Device|High Intensity Focused Ultrasound|
15981861|NCT03022669|Behavioral|Text Message|Annie (VA text messaging program) or mobile Health manager (private text messaging program for non-VA female participants recruited at non-VA facility)
15981862|NCT03022669|Behavioral|Mobile Application|
15981863|NCT03022669|Other|Website|American Heart Association patient education website
15981864|NCT03022656|Device|Active Brace system|
15981865|NCT03022643|Behavioral|Interpersonal Social Rhythms Psychotherapy|The treatment involves 8-weeks of individual psychotherapy. Weekly sessions will be 60-minute long and will take place at the Pain Research Center. The treatment focuses on 1) the link between life events, pain severity, sleep disturbances, fatigue, and mood, 2) social and behavioral rhythms and sleep-wake disturbances, 3) identification and management of rhythm dysregulation and the triggers for it, 4) allowing and facilitating the mourning of the loss healthy self, 5) identification and appropriate management of symptoms.
15981866|NCT03022643|Other|Bright Light Device|All patients will be provided with a bright light device (Re-Timer) and will be instructed to use it in the first 2-hours of the day (for a minimum of 30 minutes) throughout the 8-week treatment period.
15981867|NCT03022630|Other|Comprehensive Palliative Care services|Participants who are randomly assigned to the intervention arm will receive informational materials, comprehensive inpatient palliative care consultations with a palliative care physician or nurse practitioner, in addition to standard hepatic care. If the patient is discharged, follow-up consults will be provided by a palliative care nurse via telephone contact. Telephone contacts will occur on a flexible schedule (e.g., weekly, bi-weekly, monthly) based on the needs and wishes of the patient, at a minimum frequency of once a month. If a need for further care is identified from a telephone contact, appropriate follow-up (referral, appointment, clinical communication, etc.) will occur per standard procedures. If the participant is readmitted, the consultation schedule will restart.
15981868|NCT03022630|Other|Usual hepatic care|Participants randomized to the usual care arm will not be scheduled to meet with the palliative care service unless a consult is requested by the patient, the family, or treating physician. These consultations would include the same palliative care services as the intervention arm, excluding the informational patient materials and telephone consultations.
15981869|NCT03022617|Drug|Apremilast|
15981870|NCT03022604|Dietary Supplement|C4/Generation 4|12 grams of C4/Generation 4
15981871|NCT03022604|Dietary Supplement|C450X|12 grams of C450X
15981872|NCT03022604|Dietary Supplement|Placebo|12 grams of flavored dextrose
15981873|NCT03022591|Other|Management|management of twin pregnancies with a short cervix diagnosed between 16 0/7 WGA to 27 6/7 WGA.
15981874|NCT03022578|Procedure|Laser Interstitial Thermal Therapy|Undergo LITT
15981875|NCT03022578|Drug|Lomustine|Given PO
15981876|NCT03022565|Drug|Vorinostat|Study participants who meet the criteria of Class 2 uveal melanoma and no radiologic evidence of metastases will be treated with 400 mg of Vorinostat daily for 15 days.
15981878|NCT03022526|Procedure|CSE|
15981879|NCT03022526|Procedure|Epidural|
15981880|NCT03022526|Drug|Bupivacaine / fentaNYL|
15981881|NCT03022513|Other|Gluten free diet|The investigators will evaluate the prevalence of fibromyalgia-like joint/muscle pain and the possible ultrasonographical alterations (i.e. synovitis) of hands and feet joints in NCWS patient at baseline (i.e. at the moment of diagnosis) and after a gluten free diet period of almost 6 months.
15981882|NCT03022500|Drug|durvalumab + tremelimumab|Durvalumab: 1.5g Q4W plus Tremelimumab: 75mg Q4W up to 4cycle then Durvalumab 750mg Q2W, till PD or unacceptable toxicity.
15981883|NCT03022474|Behavioral|Healthy Lifestyles Intervention|The program included three major components. The first component consists of live lectures to kindergarten staff about basic nutrition and food concepts that attempted to correct false beliefs. The second component was a health curriculum for children that focused on promoting healthy nutrition habits and a healthy living style. Preschools were required to ensure that children received a health education lesson every two weeks. The third component was aimed at educating parents and consisted of lectures every two months, preschool-home communication every week and child growth monitoring every three months.
15981884|NCT03022461|Other|Long term follow-up|
15981885|NCT03022448|Other|No Intervention|This is a NIS. No intervention.
15981886|NCT03022435|Biological|TIV|Influenza Virus Vaccine Suspension for Intramuscular Injection
15981887|NCT03022435|Biological|High-Dose TIV|High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe
15981888|NCT03022435|Biological|LAIV|Live, attenuated influenza vaccine for Intranasal Spray
15981889|NCT03022422|Biological|TIV|Influenza Virus Vaccine Suspension for Intramuscular Injection
15981890|NCT03022422|Biological|High-Dose TIV|High-Dose Influenza Virus Vaccine supplied in a prefilled, single-dose syringe for intramuscular injection
15981891|NCT03022409|Drug|Ceralasertib|"Ceralasertib is an oral agent and will be dosed at 160 mg. Ceralasertib tablets should be taken at the same time each day, approximately 12 hours apart (maximum ± 2 hour window) with one glass of water.
~Ceralasertib is a potent, selective inhibitor of the serine/threonine-specific protein kinase, ataxia telangiectasia and Rad3-related protein (ATR), with good selectivity against other phosphatidylinositol 3-kinase-related kinase (PIKK) family members."
15981892|NCT03022409|Drug|Olaparib|"Olaparib is available as a green film-coated tablet containing 100 mg or 150 mg of Olaparib. Patients will be administered Olaparib orally twice daily at 300 mg bid. The Olaprib tablets should be taken at the same time each day, approximately 12 hours apart with one glass of water.
~Olaparib (AZD2281, KU-0059436) is a potent Polyadenosine 5'diphosphoribose [poly (ADP ribose)] polymerisation (PARP) inhibitor (PARP-1, -2 and -3) that is being developed as an oral therapy, both as a monotherapy (including maintenance) and for combination with chemotherapy and other anti-cancer agents."
15981893|NCT03022396|Biological|High Dose Fluzone® (intramuscular)|Licensed seasonal High dose trivalent inactivated influenza
15981894|NCT03022396|Biological|Fluzone® (intramuscular)|Licensed seasonal trivalent inactivated influenza
15981896|NCT03022370|Behavioral|Stepping Stones and Creating Futures|"Stepping Stones consists of 10 sessions. It seeks to strengthen relationships and to transform views on gender and in the process impact on exposure to, or participation in, gender-based violence and HIV risk. These cover gender and peer influences our actions; sex and love; conception and contraception; STIs and HIV; safer sex and condoms; GBV; motivations for behaviour (including influences of alcohol and poverty); and communication skills.
~Creating Futures is a facilitated group intervention of eleven sessions. It seeks to strengthen livelihoods. The key sessions include: setting medium term livelihood goals, the need for assets and coping with crises; social resources for livelihoods (trust and community participation); getting and keeping jobs; and savings and spending."
15981897|NCT03022357|Other|Patient assessment|Clinical examination, Examination, Questionnaires
15981898|NCT03022357|Radiation|DATScan|In small subgroup
15981899|NCT03022357|Radiation|Orbital X-Ray|If foreign body in eye needs exclusion
15981900|NCT03022357|Other|Magnetic Resonance Imaging (MRI)|MRI scanning of all subjects
15981901|NCT03022344|Radiation|Cardiac CT|
15981902|NCT03022318|Drug|carbidopa-levodopa 25-100 mg tablets|See arm/group descriptions
15981903|NCT03022305|Behavioral|Group one - standard therapy|Group two - standard physical therapy treatment for shoulder and hip maladjustment.
15981904|NCT03022305|Behavioral|Group two - neuromuscular therapy|Use of physical therapy treatment for shoulder and hip maladjustment.
15981905|NCT03022292|Drug|Aflibercept Ophthalmic|IAI given for active exudative macular degeneration (CNV, SRF, PED) per SOC
15981906|NCT03022292|Device|optovue angiovue|FDA approved Optovue Angiovue will be used to monitor progression and responsiveness of active exudative macular degeneration to IAI.
15981907|NCT03022279|Procedure|TAP Blocks|ultrasound guided transversus abdominis plane block utilizing 0.2% ropivacaine
15981908|NCT03022279|Procedure|local wound infiltration|local anesthesia provided at the surgical site utilizing 0.2% ropivacaine
15981909|NCT03022279|Drug|0.2% ropivacaine|2.5 mg/kg or 1 mL/kg of 0.2% ropivacaine
15981910|NCT03022279|Device|ultrasound|ultrasound guidance
15981911|NCT03022266|Behavioral|Financial Incentive and Mobile Phone App|Subjects receiving the Financial Incentive and Mobile Phone App will each participate in a 90-day adherence promotion program. When users first log in to the app, the screen will display an incentive of $150 that participants have earned by enrolling in the program. Participants will be told that each missed medication check-in will result in a $2 deduction from the account before it is paid out. Each $50 portion (minus any penalties) of the $150 incentive will be paid out in 30-day installments by remotely crediting a previously distributed debit card. Adherence will be measured simultaneously by app photos and CleverCap(R) electronic monitoring (EM) devices filled with a 90-day supply of aspirin. Claims data will be analyzed for a 90 day period to account for any hospital admissions.
15981912|NCT03022253|Biological|Liberal platelet transfusion|"Liberal platelet transfusion: In Intervention group the investigators will transfuse platelet concentrates to maintain a platelet count above 1,00,000 per microliter until one of the following endpoints is met, whichever is applicable:
~PDA closes or
~A maximum of 120 hours after the point of randomisation"
15981913|NCT03022253|Biological|Restrictive platelet transfusion|"The investigators will transfuse platelets only if:
~(i) Platelet count is < 20,000 per microliter or (ii) Subject has a clinical bleed or (iii) Subject has platelet count < 50000 per microliter and requires a major non-neurosurgical interventional procedure as per the current standard of care, or (iv) Subject has a platelet count < 1, 00,000 per microliter and requires a neurosurgical procedure"
15981951|NCT03021980|Behavioral|SuperFIT|Behavioural intervention with two components. One component will consist of social and physical environmental changes at the preschools and the other component consists of a family educational program.
15981914|NCT03022253|Drug|Paracetamol|"As all subjects recruited in the trial will have hemodynamically significant (hs) PDA, they will all be medically treated as per standard of care. Treatment regimens will be as follows, depending on the discretion of the treating physician:
~Paracetamol:
~Dosage-15 mg/kg/dose every 6 hourly x 12 doses Route - IV"
15981915|NCT03022253|Drug|Ibuprofen|"As all subjects recruited in the trial will have hemodynamically significant (hs) PDA, they will all be medically treated as per standard of care. Treatment regimens will be as follows, depending on the discretion of the treating physician:
~Ibuprofen:
~Dosage-10 mg/kg stat followed by 5 mg/kg/dose x 2 doses at 24 hours intervals Route- oral"
15981916|NCT03022240|Drug|Propofol|The child will be randomized via a block design to receive either a volatile anesthetic (induction: sevoflurane), or total intravenous anesthetic technique (induction: propofol)
15981917|NCT03022240|Drug|Sevoflurane|The child will be randomized via a block design to receive either a volatile anesthetic (induction: sevoflurane), or total intravenous anesthetic technique (induction: propofol)
15981918|NCT03022240|Drug|Ametop|Each patient will receive Ametop local anesthetic to the dorsum of both hands 30-45 minutes prior to induction.
15981919|NCT03022240|Drug|Ondansetron|Each patient will receive the antiemetic ondansetron 0.1mg/kg IV.
15981920|NCT03022227|Other|telemedicine|telemedicine applied to adult cochlear implant users' follow-up
15981921|NCT03022214|Dietary Supplement|Placebo|Microcrystalline cellulose capsules x 5 morning and night with meals for two days prior to exercise test and 5 capsules taken on the morning of the test with the first meal
15981922|NCT03022214|Dietary Supplement|Intervention|"Daily capsules will be divided into two servings, one serving to be taken in the morning with breakfast, and one serving to be taken in the evening with dinner. Each serving containing 5 capsules, as follows:
~EnduraCell broccoli sprout powder: 3 capsules
~Bulk Powders Green tea extract: 1 capsule
~Bulk Powders Cinnamon Bark Extract: 1 capsule taken for two days prior to exercise test and 5 capsules taken on the morning of the test with the first meal"
15981923|NCT03022201|Drug|DA-9701|Following 2-week screening period, study participants in this group will be given a standard dose of DA-9701 (30 mg t.i.d). Concomitant anti-PD medication will be continued without modification during the trial. The investigators will evaluate dyspepsia and constipation symptoms, gastric emptying by MRI, UPDRS and clinical variables at baseline and at the end of the study.
15981924|NCT03022201|Drug|Domperidone|Following 2-week screening period, study participants in this group will be given a standard dose of domperidone (10 mg t.i.d). Concomitant anti-PD medication will be continued without modification during the trial. The investigators will evaluate dyspepsia and constipation symptoms, gastric emptying by MRI, UPDRS and clinical variables at baseline and at the end of the study.
15981925|NCT03022201|Drug|Placebo domperidone|
15981926|NCT03022201|Drug|Placebo DA-9701|
15981927|NCT03022175|Drug|SPR741|"SAD: Double-blind dosing will occur in cohorts 1 through 8. Six participants will receive single doses of SPR741. The dose escalation steps may be altered following review of the safety data upon completion of each cohort.
~MAD: The Safety Management Group will evaluate the safety and tolerability data obtained for the participants in Cohorts 1-5 to determine the appropriate dose level of intravenous q8h dosing of SPR741 to be utilized in the first cohort (Cohort 9) in the MAD. Dosing will commence on the morning of Day 1. Three doses will be administered per day at approximately 8 hours apart. Daily dosing will continue for a total of 14 consecutive days."
15981928|NCT03022175|Drug|Placebo|0.9% sodium chloride for injection. SAD: Two participants in each cohort will receive matching placebo. MAD: Two participants in each cohort will receive matching placebo.
15981929|NCT03022149|Device|Doctormate® (200mmHg)|Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 200mmHg.
15981930|NCT03022149|Device|Doctormate® (60mmHg)|Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 60mmHg.
15981931|NCT03022136|Other|cold sensation method|Complete sensory loss to ice will be evaluated form anterior median line to posterior median line at the end of surgery.
15981932|NCT03022123|Drug|PL-doxorubicin and epirubicin|PL-doxorubicin 35-40 mg/m(2) and epirubicin 70 mg/m(2) were given in combination with standard dosage of prednisone, vincristine, cyclophosphamide, rituximab (according to CHOP-R regimen) every 21 days for six courses.
15981933|NCT03022110|Device|Endoscopic Ultrasound-guided Drainage|Pancratic pseudocyst drainaged under the guide of Endoscopic Ultrasound
15981934|NCT03022097|Drug|Aclidinium bromide/formoterol Fixed-Dose Combination|Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination, twice per day via Genuair
15981935|NCT03022097|Drug|Aclidinium bromide|Inhaled Aclidinium bromide 400 μg, twice per day via Genuair
15981936|NCT03022097|Drug|Formoterol Fumarate|Inhaled Formoterol Fumarate 12 μg, twice per day via Turbuhaler
15981937|NCT03022097|Drug|Placebo|Inhaled dose-matched placebo, twice per day via Genuair or via Turbuhaler
15981938|NCT03022084|Device|Desyncra|This group will use the sound-therapy device, Desyncra™ for Tinnitus Therapy System.
15981939|NCT03022084|Other|Cognitive Behavioral Therapy|Standard of Care
15981940|NCT03022071|Other|Cognitive behavior therapy|In this study we want to compare CBT and PDT and examine whether some patients will benefit from CBT and other from PDT. More specifically we want to examine moderators and mediators for improvement in depressive symptoms in the two interventions arms.
15981941|NCT03022058|Device|Ear-EEG system|Measurement of the neural activity in the brain by use of the Ear-EEG device, which is a customized earplug containing 6 embedded dry electrodes placed inside the ear canal and in the concha of the ear.
15981942|NCT03022045|Drug|risankizumab|risankizumab administered by subcutaneous injection
15981943|NCT03022032|Device|Fitbit Zip|Fitbit Zip
15981944|NCT03022032|Other|HOPE App|HOPE App
15981945|NCT03022032|Other|Standard of Care|Standard of Care
15981946|NCT03022032|Device|Fitbit Charge 2|Fitbit Charge 2
15981947|NCT03022032|Other|SMART Study Intervention|SMART study app + Beiwe study app + Fitbit
15981948|NCT03022019|Device|ReNovaCell|
15981949|NCT03022006|Drug|elbasvir, grazoprevir|
15981950|NCT03021993|Drug|Nivolumab|Nivolumab will be administered on days 1, 15 and 29. If disease has progressed at day 29, the subject will proceed to surgery. If a response or stable disease is present after the third dose, a fourth dose will be given on day 43, then the subject will proceed to surgery.
15981952|NCT03021954|Biological|Platelet Rich Plasma|Platelet rich plasma is produced by obtaining patient's whole blood and processed by centrifugation and activation by CaCl2.
15981953|NCT03021941|Drug|Elelyso 60 units/kg|All patients receive Elelyso 60 units/kg.
15981954|NCT03021928|Other|Time-To-Treatment Randomization|The time after symptom onset to initiate treatment will be randomized to one of four possible treatment arms: 60 hours, 132 hours, 228 hours, or 324 hours (+/- 12 hours each).
15981955|NCT03021915|Other|OvaPrime Treatment|The treatment is based on identified EggPC cells in the outer-most layer of the ovary. During OvaPrime, the EggPC cells are isolated from biopsy tissue obtained from the outer layer of the ovary. OvaScience separates the EggPC cells and these isolated cells are then returned to the IVF clinic - there is no culture or expansion of the EggPC cells during this process. Upon receipt of the autologous EggPC cells, the clinic initiates the process of reintroducing the cells into the follicular development zone of the woman's own ovary using a laparoscopic procedure. Once in the ovary, the EggPC cells have the opportunity to develop and mature into fertilizable eggs naturally or with controlled ovarian hyperstimulation (when stimulated by exogenous gonadotropins) using standard IVF protocols.
15981956|NCT03021902|Drug|IV amino acids|IV amino acids delivered by continuous infusion, such that the total enteral and IV protein will be between 2.0-2.5 g/kg/day as a combination of amino acid infusion plus standard feeding.
15981957|NCT03021902|Device|In-bed cycle ergometry exercise|"In-bed cycle ergometry exercise delivered in 45-minute sessions once-daily 5 days per week according to a detailed specific protocol that includes a safety check in combination with vigorous verbal encouragement from trained research staff delivering the intervention to promote active cycling.
~Cycling is protocolized to provide graduated increases in resistance during each session and between daily sessions. Cycling will continue through ICU discharge or 21 calendar days after randomization. The intervention will specifically occur during ICU stay."
15981958|NCT03021889|Behavioral|Nutritional therapy|The nutritional therapy intervention group received monthly nutritional guidelines for 12 weeks focusing on the diet for dyslipidemia, based on the recommendation of the type I diet of the Clinical Protocol and Therapeutic Guidelines for Management of HIV Infection in children and adolescents. In addition, participants in the intervention group received weekly phone calls for nutritional counseling.
15981959|NCT03021889|Behavioral|Control group|The control group was followed according to the ambulatory care routine, which consists of medical follow-up by the assistant team.
15981960|NCT03021876|Drug|L-carnitine|treatment with oral L-carnitine, 1500 mg/body per day
15981961|NCT03021876|Other|usual intake|baseliner
15981962|NCT03021863|Behavioral|Group A Reminder|Tone of reminder email (duty 14 days followed by duty 28 days for non-responders)
15981963|NCT03021863|Behavioral|Group B Reminder|Tone of reminder email (encouragement 14 days followed by encouragement 28 days for non-responders)
15981964|NCT03021863|Behavioral|Group C Reminder|Tone of reminder email (encouragement 14 days followed by duty for non-responders 28 days)
15981965|NCT03021863|Behavioral|Group D Reminder|Tone of reminder email (duty 14 days followed by encouragement for non-responders 28 days)
15981966|NCT03021863|Behavioral|Group E Reminder|Tone of reminder email (generic reminders 14 days followed by 28 days for non-responders)
15981967|NCT03021863|Behavioral|Group F Reminder|Tone of reminder email (generic 14 days followed by duty for non-responders 28 days)
15981968|NCT03021863|Behavioral|Group G Reminder|Tone of reminder email (generic 14 days followed by encouragement for non-responders 28 days)
15981969|NCT03021863|Behavioral|Group H Reminder|Tone of reminder email ( duty14 days followed by generic for non-responders 28 days)
15981970|NCT03021863|Behavioral|Group I Reminder|Tone of reminder email (encouragement 14 days followed by generic non-responders 28 days)
15981971|NCT03021850|Procedure|Flexibility training with or without different thermal modalities|Flexibility training of the hamstring muscles by passive static stretching of the hamstring muscles in 10 30-second repetitions, with a 10-second pause between each repetition associated with or without short-wave heating or cryotherapy
15981972|NCT03021837|Other|antenatal corticosteroid|Will look at maternal glucose level after corticosteroids
15981973|NCT03021811|Device|KLOX LumiHeal BioPhotonic System|Real-life use of KLOX LumiHeal BioPhotonic System in combination with standard of care.
15981974|NCT03021798|Other|No Drug and no aspecific intervention|No intervention
15981975|NCT03021785|Biological|TK001|TK001 will be administered intravitreal injection.
15981976|NCT03021772|Drug|Neostigmine|Patients will receive intravenous 3mg/kg lidocaine 2 % (diluted with normal saline to 40 ml) + 0.5 mg neostigmine for Bier block.
15981977|NCT03021772|Drug|Dexamethasone|Patients will receive intravenous 3mg/kg lidocaine 2 % (diluted with normal saline to 40 ml) + 8 mg dexamethasone for Bier block.
15981978|NCT03021759|Behavioral|Active choice|Statin options are framed to physicians as an active choice to prescribe or not prescribe a statin
15981979|NCT03021759|Behavioral|Social comparison feedback|Statin prescribing rates are communicated to physicians and along with how their performance compares to their peers
15981980|NCT03021746|Behavioral|Diabetes Self Management Support (DSMS)|
15981981|NCT03021733|Procedure|Operative management|Rotator cuff surgery
15981982|NCT03021720|Procedure|Arterial access|Location of arterial puncture
15981983|NCT03021694|Dietary Supplement|Testing of micellar casein, blended micellar casein and native whey, versus native whey to determine post-ingestion aminoacidemia, glycemia, and insulinemia in young adult men|
15981984|NCT03021681|Other|autologous bronchial basal cell transplantation|the investigators obtained extraction bronchial basal cells micro tissue from 3~4 grade bronchus, then purified and selectively amplified bronchial basal cells to reserve . After a period of time, the basal lamina of the bronchial epithelial cells can be stored in the liquid nitrogen cell bank for a long time. Before applied to the patient, bronchial basal cells need to go through a series of strict examination. Then, bronchoscopy was performed again and the bronchial basal lamina suspension was injected directly into the lesion site .
15981985|NCT03021668|Device|Prevena Peel & Place Dressing|Prevena Peel & Place Dressing is a device that can be used for closure of the surgical site. It provides negative pressure to the surgical wound
15981986|NCT03021668|Other|Standard Closure of the Surgical Incision|This would involve standard closure of the incision site
15982053|NCT03021174|Behavioral|EXCAP Exercise|12 weeks of at-home walking and resistance exercise
15981987|NCT03021655|Behavioral|Adventure-based intervention group|One-day adventure-based training will be assigned to subjects and the activities include wall climbing, rope course and health talk on mood, pressure management and smoking cessation.
15981988|NCT03021655|Behavioral|WhatsApp intervention group|A WhatsApp group will be opened for the subjects and we will send messages about mood and pressure management to them and encourage them to quit smoking. The subjects can share their unhappy things in the group.
15981989|NCT03021655|Behavioral|Control group|Telephone follow-up will be conducted at 1-week, 1-, 3-, 6-, 9-, 12-, 24-month and smoking cessation counselling will be delivered to the subjects.
15981990|NCT03021642|Drug|Tepotinib test (Treatment Period 1)|Subjects will be administered a single oral dose of test treatment of film-coated tepotinib tablet (1 * 500 mg tablet) in Treatment period 1 (Day 1)
15981991|NCT03021642|Drug|Tepotinib reference (Treatment Period 2)|Followed by a 21-day washout after Treatment period 1 (Day 1), subjects will be administered a single oral dose of reference treatment of film-coated tepotinib tablet (5 * 100 mg tablet) in Treatment period 2 (Day 22)
15981992|NCT03021642|Drug|Tepotinib reference (Treatment Period 1)|Subjects will be administered a single oral dose of reference treatment of film-coated tepotinib tablet (5 * 100 mg tablet) in Treatment period 1 (Day 1)
15981993|NCT03021642|Drug|Tepotinib test (Treatment Period 2)|Followed by a 21-day washout after Treatment period 1 (Day 1), subjects will be administered a single oral dose of test treatment of film-coated tepotinib tablet (1 * 500 mg tablet) in Treatment period 2 (Day 22)
15981994|NCT03021629|Other|Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by an enzyme-linked immuno-absorbent assay|
15981995|NCT03021616|Other|energy drink|32oz of commercially available energy drink
15981996|NCT03021616|Other|Moxifloxacin 400mg|400mg moxifloxacin active control drink
15981997|NCT03021616|Other|Placebo|Placebo drink
15981998|NCT03021603|Behavioral|Brief Hope Intervention|"The present Brief Hope Intervention (BHI) is a four-weeks individual intervention:
~Hope enhancement strategies included sharing and recalling past successes, hope-based goal mapping exercises, examining possible pathways to reach the targeted goals, hope visualization exercise and positive self-talk.
~Purpose: help participants to develop positive thoughts.
~The programme consists of four sessions:
~Two face-to-face sessions (1-hour) and two telephone follow up (30 mins) Homework: A booklet is prepared for the participants for reviewing their planned goals and recording achieved targets."
15981999|NCT03021590|Drug|Clarithromycin 500Mg Oral Tablet|"Amoxicillin 1000 mg Tablets every 12 hours , Esomeprazole 20 mg Capsule days all
~,Clarithromycin 500 mg Tablets and Tinidazole 500 mg Tablets every 12 hours for 14 days all by mouth"
15982000|NCT03021590|Drug|Levofloxacin 500Mg Oral Tablet|Amoxicillin 1000 mg Tablets , Esomeprazole 20 mg Capsule,Levofloxacin 500 mg Tablets and Tinidazole 500 mg Tablets all every 12 hours for 14 days all by mouth
15982001|NCT03021577|Device|Orbital Atherectomy System (OAS)|The Cardiovascular Systems, Inc. (CSI) Diamondback 360 Coronary Orbital Atherectomy System (OAS) is a catheter-based system designed for facilitating stent delivery in patients with coronary artery lesions. The OAS consists of the hand-held CSI DIAMONDBACK 360 Coronary Orbital Atherectomy Device (OAD), the CSI Saline Infusion Pump (OAS pump), the CSI ViperWire Advance Coronary Guide Wire (VIPERWIRE guide wire), and the CSI ViperSlide Lubricant.
15982002|NCT03021577|Device|Rotablator Rotational Atherectomy System|The Rotablator Rotational Atherectomy System is comprised of a Rotablator RotaGlide, a Rotablator RotaLink Plus/RotaWire/Console
15982003|NCT03021577|Procedure|Magnetic Resonance Imaging (MRI)|In a subset of patients (n= 20) a baseline cardiac MRI will be performed prior to PCI and repeated 24 hours after PCI to quantify the total volume of myocardial necrosis secondary to PCI.
15982004|NCT03021564|Other|cardiopulmonary resuscitation|Basic cardiopulmonary resuscitation : external electric shock, external cardiac massage, adrenaline injection ...
15982005|NCT03021538|Device|Extracorporeal Membrane Oxygenation|ECMO is used during lung transplant procedure
15982006|NCT03021538|Device|Cardiopulmonary Bypass|CPB is used during lung transplant procedure
15982007|NCT03021525|Procedure|Individualized Goal Directed Therapy|The trial intervention period will commence from the induction of anesthesia until 8 hours after surgery, or until discharging from the postoperative intensive or intermediate care unit. All patients in the intervention group receive basic vital sign monitoring. For inotropic support dobutamine, and as vasopressor norepinephrine are drugs of choice. Hemodynamic management is performed according to standard treatment until an arterial line is placed. The signal of the arterial line is then processed either by calibrated or non-calibrated pulse contour analysis for pulse pressure variation (PPV) and cardiac index (CI) measurement. Fluid challenge will be performed by infusion of 500 ml in <15 minute. Choice of fluid in case of indicated fluid loading is determined on basis of the recent guideline for intravasal volume therapy. Patients receive fluids and vasoactive agents following a protocol of individualized parameters regularly achieved by extended hemodynamic monitoring.
15982008|NCT03021525|Procedure|Control Group|Patients in the control group will be treated according to established basic treatment goals (heart rate <100 bpm, mean arterial pressure >65 mmHg, SpO2>94%, and core temperature >36° C). Basic anesthesiological monitoring by five-lead-electrocardiogram, pulse oximetry, non-invasive blood pressure monitoring and capnography is performed in every patient of the control group. Placement of an arterial and central venous line, as well as fluid and catecholamines administration, are at the discretion of the treating clinician.
15982009|NCT03021512|Procedure|Phaco with Restor|Phacoemulsification with bilateral bifocal intraocular lenses implantation
15982010|NCT03021512|Procedure|Phaco with Panoptix|Phacoemulsification with bilateral trifocal intraocular lenses implantation
15982011|NCT03021499|Drug|Voclosporin|calcineurin inhibitor
15982012|NCT03021499|Drug|Placebo Oral Capsule|matching placebo capsule
15982013|NCT03021486|Drug|Chlorpromazine|Given IV
15982014|NCT03021486|Drug|Haloperidol|Given IV
15982015|NCT03021486|Other|Quality-of-Life Assessment|Ancillary studies
15982016|NCT03021486|Other|Questionnaire Administration|Ancillary studies
15982017|NCT03021460|Drug|Ibrutinib|Given PO
15982018|NCT03021460|Other|Laboratory Biomarker Analysis|Correlative studies
15982019|NCT03021460|Biological|Pembrolizumab|Given IV
15982054|NCT03021174|Behavioral|Nutrition Education Control|12 weeks of implementing eating tips
15982322|NCT03019263|Other|Control|Nutritional counseling
15982020|NCT03021434|Other|Community and household water safety education sessions|Data collectors will give a short community presentation on water treatment, as well as safe water handling and storage. Then, data collectors will immediately visit households and review this information. Data collectors will return within 72 hours and review this information once more.
15982021|NCT03021434|Other|Household-specific water quality information|Household specific water quality data will be provided in two ways. In the Standard Testing Arm, water quality data will be analyzed in a laboratory by standard methods and results will be delivered to households. In the Test Kit arm, water quality data will be analyzed in households using provided water test kits.
15982022|NCT03021434|Other|Low-cost microbiological water test kits|Intervention component consists of low-cost, biodegradable that tests for the presence of E. coli in water samples. The test uses Aquatest broth medium with resorufin methyl ester chromogen. Presence of E. coli (positive test) imparts bright red color, making it easy to use/interpret at the household level with minimal training
15982023|NCT03021421|Procedure|intratechal (subarachnoidal )injection|10 mg (2 cc) intrathecal single shot injection
15982024|NCT03021421|Procedure|lombar plexus and sciatic nerve injection|USG -guided lumbar plexus visualised and 20 ml local anaesthetic mixture (15 cc %0,5 Bupivacaine Hydrochloride 5 cc and %2 Lidocaine 5 cc ) for lombar plexus single shot injection
15982025|NCT03021408|Other|MIRT + Treadmill|PD patients will undergo a 4-week MIRT. All patients in the MIRT+Treadmill Plus group will undergo 10-minutes treadmill training twice per day, 5 times a week, for 4 weeks.
15982026|NCT03021408|Other|MIRT + Treadmill Plus|PD patients will undergo a 4-week MIRT. All patients in the MIRT+Treadmill Plus group will undergo 10-minutes treadmill-plus training (with visual and auditory cues) twice per day, 5 times a week, for 4 weeks.
15982027|NCT03021408|Other|MIRT + Virtual Reality|PD patients will undergo a 4-week MIRT. All patients in the MIRT+Virtual Reality (VR) group will undergo 10-minutes VR training with enhanced perceptions (visual, auditory, and haptic inputs), twice per day, 5 times a week, for 4 weeks.
15982028|NCT03021395|Drug|Decitabine|Decitabine at a dose of 20mg/㎡/d on day 1-5.
15982029|NCT03021382|Other|data collection, non-intervention|
15982030|NCT03021369|Device|Pleural drainage system|Pleural drainage system is connected to the chest tubes after surgery.
15982031|NCT03021356|Device|Aortic xenograft|After randomization, the aortic xenograft is implanted in the standard fashion
15982032|NCT03021343|Drug|Colchicine|colchicine given as per trial protocol
15982033|NCT03021330|Drug|Daunomycin and Cytarabine (DA Regimen)|"Cytarabine at a dose of 100mg/㎡/d on day 1-7.
~Daunomycin at a dose of 60mg/㎡/d on day 1-3."
15982034|NCT03021330|Drug|Daunomycin and Cytarabine (Intermediate Dose of DA Regimen)|"Cytarabine at a dose of 100mg/㎡/d on day 1-4 and 1g/㎡/d on day 5-7.
~Daunomycin at a dose of 60mg/㎡/d on day 1-3."
15982035|NCT03021317|Drug|ACTHar|The patients will be given 80 Units subcutaneously of ACTHAR at the time of MS relapse daily for 10 days.
15982036|NCT03021304|Drug|Mepolizumab|It is a clear to opalescent, colorless to pale yellow sterile solution for SC injection, supplied in a single-use, prefilled syringe containing 100 mg/mL mepolizumab with sodium phosphate, citric acid, sucrose EDTA and polysorbate 80 within a safety syringe.
15982037|NCT03021291|Device|Gelesis100 (2.25 g)|Three capsules of Gelesis100, each containing a 750 mg mixture of two food-grade materials: carboxymethylcellulose that is cross-linked with citric acid.
15982038|NCT03021278|Other|Saline injection|In the saline injection group, low back pain will be induced via 1.0 ml hypertonic (5% NaCl) saline bolus injection which is a commonly used model of acute low back pain. Saline will be injected into the right (or left) lumbar longissimus muscle 50 mm lateral to the spinous process just above (5 mm) previously marked point. Injections will be performed by a physician under ultrasound imaging guidance to ensure that each single injection will be equally placed at a depth of 30 mm. The side for the pain induction will be randomised across subjects. The place of needle insertion and corresponding point on the opposite side of the body will be covered by placing a small piece of adhesive plaster.
15982039|NCT03021278|Other|Sham injection|In the sham-injection group (placebo comparator), a real needle will be shown to the participants to imitate and produce the anticipation of a pain experience. A pinprick sensation will be produced by a weighted stimulus applied perpendicularly to the skin just above without piercing the skin. A stimulus of 512 mN will be used to produce a pinprick sensation and activation of cutaneous nociceptors. Adhesive tapes covering stimulation points will also be provided.
15982040|NCT03021265|Drug|T80/A5/H12.5 FDC|Drug
15982041|NCT03021252|Device|High intensity IEMT|Training load will be the maximum inspiratory / expiratory load defined according to patient tolerance equivalent to 10 maximal repetitions (RM) as 10 consecutive inspirations / expirations (x 5 set), three times per day, during 8 weeks. External loads will be increased weekly at intervals of 10 cm H2O as tolerated. Patients will receive standard swallow therapy consisting of swallowing manoeuvres, oral exercises, and compensatory techniques aimed to improve self-management of dysphagia and protect the airway.
15982042|NCT03021252|Device|Sham IEMT|5 sets of 10 inspirations and expirations in a sham IEMT trainer, three times a day, during 8 weeks.
15982043|NCT03021239|Procedure|Echo Guided Testing|
15982044|NCT03021239|Procedure|Hemodynamic-Echo Ramp Testing -|
15982045|NCT03021226|Behavioral|Fatherhood Development|Fatherhood Development is a curriculum based program provided by a facilitator through a skill-based education intervention.
15982046|NCT03021226|Behavioral|Relationship Enhancement|Relationship Enhancement is a curriculum based program provided by a facilitator through a skill-based education intervention.
15982047|NCT03021226|Behavioral|Financial Literacy|Relationship Enhancement is a curriculum based program provided by a facilitator through skill-based education intervention.
15982048|NCT03021200|Device|Green indocianine|Laser fluorescence using green indocianine guiding the surgical procedure.
15982049|NCT03021187|Drug|semaglutide|Oral semaglutide administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment
15982050|NCT03021187|Drug|semaglutide|Oral semaglutide (3 mg followed by 7 mg) administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment
15982051|NCT03021187|Drug|semaglutide|Oral semaglutide (3 mg followed by 7 mg and finally 14 mg) administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment
15982052|NCT03021187|Drug|placebo|Oral semaglutide placebo administered once-daily for 52 weeks as an add-on to the subjects' pre-trial insulin treatment
15982055|NCT03021161|Drug|Probiotic Formula|The intervention group will receive once daily capsules containing 109 CFU of Lactobacillus rhamnosus HN001, Lactobacillus paracasei Lpc-37 and Bifidobacterium animalis ssp. Lactis HN019
15982056|NCT03021161|Other|Placebo Oral Capsule|Capsule containing no probiotic
15982057|NCT03021148|Other|Questionnaire|Administration of questionnaire.
15982058|NCT03021135|Procedure|Conventional Endoscopic Mucosal Resection|Conventional Endoscopic Mucosal Resection
15982059|NCT03021135|Procedure|Underwater Endoscopic Mucosal Resection|Underwater Endoscopic Mucosal Resection
15982060|NCT03021122|Device|PedAMINES™ / Conventional Method|"Each nurse will be asked to prepare a 5 μg/kg/min continuous infusion of dopamine (Period 1) and then to prepare a 0.1 μg/kg/min continuous infusion of norepinephrine (Period 2) for a 25kg boy using the studied delivery devices according to the sequence randomly assigned based on a cross-over design:
~• PedAMINES™ (Period 1) and then Conventional Method (Period 2)"
15982061|NCT03021122|Device|Conventional Method / PedAMINES™|"Each nurse will be asked to prepare a 5 μg/kg/min continuous infusion of dopamine (Period 1) and then to prepare a 0.1 μg/kg/min continuous infusion of norepinephrine (Period 2) for a 25kg boy using the studied delivery devices according to the sequence randomly assigned based on a cross-over design:
~• Conventional Method (Period 1) and then PedAMINES™ (Period 2)"
15982062|NCT03021109|Device|Measurement of inferior vena cava diameters with ultrasound|The patient is placed in the supine position. Curvilinear probe is used. Subxiphoid view is obtained. The IVC is visualized in the longitudinal plane as it enters the right atrium. The diameter of the IVC for calculation of the caval index is measured 2 cm from where it enters the right atrium
15982063|NCT03021096|Other|Surveys|The study is just using validated surveys to assess pain and mood states after surgery
15982064|NCT03021083|Device|IONSYS Patch|Patient controlled transdermal fentanyl patch, IONSYS, applied to patient in place of a PCA.
15982065|NCT03021070|Other|Conditional cash transfer|For each honoured and verified health visit that is made on time following enrollment, a woman receives a cash transfer. The value reduces by one quarter for each week of delayed visit, and no reward is offered for any visit made 3 weeks after the appointment date. Transportation cost by a local taxi to the health facility, and is a value that has been approved by the research ethics committee for many studies in the region as reasonable compensation for research participants.
15982066|NCT03021057|Drug|pembrolizumab|200mg i.v. once every 3 weeks Number of Cycles: until progression or unacceptable toxicity develops
15982067|NCT03021044|Other|physical activity intervention|30, 60, 90 and 120 days after hospital discharge a clinical visit and session of physical activity training and program
15982068|NCT03021044|Other|standard of care|30, 60, 90 and 120 days after hospital discharge a clinical visit with correct style life recommendation
15982069|NCT03021031|Other|Observational|Observational study
15982070|NCT03021018|Drug|Brivaracetam|"Pharmaceutical Form: Solution for infusion
~Concentration: 10 mg/ml
~Route of Administration: intravenous"
15982071|NCT03021018|Drug|Lorazepam|"Pharmaceutical Form: Solution for injection
~Route of Administration: intravenous"
15982072|NCT03021005|Behavioral|HIV Self-testing|
15982073|NCT03020992|Drug|Certolizumab Pegol|"pharmaceutical form: solution for infusion in prefilled syringe
~concentration: 200 mg/mL
~route of administration: subcutaneous"
15982074|NCT03020979|Drug|Apatinib|Patients will take 500mg apatinib daily orally.
15982075|NCT03020966|Drug|Acetaminophen|Oral acetaminophen, intravenous placebo
15982076|NCT03020966|Drug|Acetaminophen|Intravenous acetaminophen, oral placebo
15982077|NCT03020953|Other|Exercise + Estrogen|12 weeks resistance training and estrogen patches
15982078|NCT03020953|Other|Exercise + Placebo|12 weeks resistance training and placebo patches
15982079|NCT03020940|Drug|Cefuroxime Axetil Dispersible Tablets|"Oral. This product can be taken orally, can also be added to the amount of warm water after mixing evenly.
~Adult general 0.25g (one time), 2 times a day, the general course of treatment for 5 to 10 days.
~Severe Infection or suspected pneumonia, a 0.5g (once 2), 2 times a day; general urinary tract infection, a Times a 0.125g (one and a half tablets), 2 times a day; for patients with no complications of gonorrhea recommended dose of 1g (4 Tablets), a single taking.
~Children generally a dose of 0.125g (one-half tablets), 2 times a day; for less than two years of age in the middle ear Inflammatory patients, a 0.125g (one half tablets), 2 times a day; for greater than two years of otitis media patients, one Times a 0.25g (one time), 2 times a day; more than 12 years of age in children, the same dose for adults"
15982080|NCT03020927|Behavioral|Reciprocal Imitation Training (Therapist-Delivered)|Naturalistic Developmental Behavioral Intervention aimed at improving social imitation skills.
15982081|NCT03020927|Behavioral|Reciprocal Imitation Training (Therapist + Parent Delivered)|Naturalistic Developmental Behavioral Intervention aimed at improving social imitation skills, using a combination of therapist-delivered intervention and parent training to deliver intervention in the home setting.
15982082|NCT03020914|Device|Audiovisual Distraction|watching a movie using video glasses and headphones
15982083|NCT03020901|Drug|Teicoplanin for Injection|Use Teicoplanin for Injection
15982084|NCT03020888|Device|Magseed and Sentimag|Magseed marker and Sentimag probe for lesion localization
15982085|NCT03020875|Drug|Ofirmev|Intravenously administered acetaminophen.
15982086|NCT03020875|Drug|Per Os Acetaminophen|Orally administered acetaminophen.
15982087|NCT03020862|Dietary Supplement|Dietary beetroot juice|Consumed as concentrated beetroot juice from James White Drinks England (Beet-it) and contained 300 mg dietary nitrate. Dose: 2x70 mL consumed twice a day for six days.
15982088|NCT03020836|Behavioral|Referral to primary care physician for hypertension control|Referral to primary care physician for hypertension control
15982089|NCT03020836|Behavioral|Referral to smoking quit line|Referral to Maryland Tobacco/Smoking quit line for help with smoking cessation
15982090|NCT03020823|Drug|SCB01A|intra-subject dose escalation, 12, 18, 24 mg/m2, 24h-IV infusion (in the vein) on day 1 and 8 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
15982091|NCT03020810|Drug|Dupilumab|The patient will receive a 600 mg subcutaneous dupilumab loading dose on Day 1, and then 300 mg subcutaneous dupilumab every 2 weeks
15982092|NCT03020797|Drug|Perampanel|
15982093|NCT03020797|Drug|Placebo Oral Tablet|
15982094|NCT03020784|Drug|Placebo|Placebo
15982095|NCT03020784|Drug|PF-06818883|Treatment
15982098|NCT03020758|Dietary Supplement|Dried Fruit|Mixture of equal parts 4 dried fruits (figs, raisins, dates, plums) totaling 3/4 cup daily.
15982099|NCT03020758|Other|High Carbohydrate Snack|Calorie-matched carbohydrate-rich snack.
15982100|NCT03020745|Drug|GSK3389404|GSK3389404 is available as Clear colorless to slightly yellow solution for injection.
15982101|NCT03020745|Drug|Placebo|Placebo is available as a Clear colorless solution.
15982102|NCT03020732|Procedure|test groups|Coronally advanced flap procedure is a mucogingival surgery technique that was used to prepare recipient sites. Concentrated growth factor(CGF) membranes were placed over the exposed root surface. The flap was advanced 1 mm coronally from CEJ to completely cover.
15982103|NCT03020732|Procedure|control groups|Coronally advanced flap procedure is a mucogingival surgery technique that was used to prepare recipient sites. Subepithelial connective tissue graft was placed over the exposed root surface. The flap was advanced 1 mm coronally from CEJ to completely cover.
15982104|NCT03020719|Drug|Oral Glutathione|Oral Glutathione oral powder
15982105|NCT03020719|Drug|Placebo|Placebo oral powder
15982106|NCT03020706|Drug|Magnesium Sulfate, Injectable|magnesium sulphate intravenous administration during general anesthesia
15982107|NCT03020693|Procedure|Invasive electrostimulation combined with exercises|Procedure for producing analgesia by introducing the TENS current through a needle combined with a exercises program.
15982108|NCT03020693|Procedure|Placebo electrostimulation and exercises|First: Sham dry needling. After: electrostimulation using surfaces electrodes. Finally a exercises program.
15982109|NCT03020680|Dietary Supplement|Coenzyme Q10|To examine whether 200 mg/d ubiquinol for 14 days increase coenzyme Q10 status by a larger degree than 200 mg/d ubiquinone
15982110|NCT03020654|Other|Virtual environment with fast moving objects|A beach/park environment with graded moving objects, the individual will complete head and eye exercises.
15982111|NCT03020654|Other|Virtual environment with no movement|A beach/park environment with static objects, the individual will complete head and eye exercises.
15982112|NCT03020641|Procedure|Low pressure pneumoperitoneum|Low pressure pneumoperitoneum
15982113|NCT03020641|Procedure|standard pneumoperitoneum pressure|standard pneumoperitoneum pressure
15982114|NCT03020628|Biological|NBP607-QIV|For subjects 6 months to 35 months of age, Single dose administration, Intra-muscular [* 2 doses for subjects without influenza vaccination history, administered at least 4 weeks apart]
15982115|NCT03020628|Biological|NBP607-TIV|For subjects 6 months to 35 months of age, Single dose administration, Intra-muscular [* 2 doses for subjects without influenza vaccination history, administered at least 4 weeks apart]
15982116|NCT03020615|Drug|Hydroxyurea|Given orally once daily.
15982117|NCT03020602|Other|Laboratory Biomarker Analysis|Correlative studies
15982118|NCT03020602|Other|Pharmacological Study|Correlative studies
15982119|NCT03020602|Drug|Ubidecarenone Injectable Nanosuspension|Given IV
15982120|NCT03020589|Drug|Tacrolimus|See description in arm/group sections
15982121|NCT03020576|Device|Amadeo Hand Robot Device|This is a robotic device designed to offer rehabilitation to remediate weakness and limitations of range of motion of the hand and fingers.
15982122|NCT03020576|Other|Conventional Therapy|This arm involves treatment using conventional methods designed to promote range of motion, strength, coordination and function at the level of the shoulder, elbow, wrist and hand.
15982123|NCT03020563|Drug|Liposomal Bupivacaine|Liposomal Bupivacaine
15982124|NCT03020563|Drug|Bupivacaine|Bupivacaine
15982125|NCT03020537|Biological|Fluzone|Fluzone (Influenza Virus Vaccine) Suspension for Intramuscular Injection 2013-2014 Formula.
15982126|NCT03020524|Biological|Autologous CD4 T-Cells|all participants will receive a single infusion of C34-CXCR4-modified CD4+ T-cells at one of 3 dose levels. The first 3 subjects will receive dose level 1 of 0.8-1x109 transduced CD4+T-cells. Provided no dose limiting toxicity (DLT) is seen at the first dose level, the next 3 subjects will receive infusion at the 2nd dose level of 2.4-3x109 transduced CD4+ T-cells. If no DLT occurs at that dose, the final 3 subjects will receive the 3rd dose level of 0.8-1x1010 transduced CD4+ T-cells. In the event of a DLT (grade 3 or higher unexpected, related AE) recruitment will be paused pending DSMB decision
15982127|NCT03020511|Other|Ancient wheat flours|Ancient wheat flours will be administered in open label for 30 days
15982128|NCT03020498|Biological|Fluzone|Influenza Virus Vaccine Suspension for Intramuscular Injection
15982129|NCT03020498|Biological|FluMist|Influenza Virus Vaccine Live, Intranasal Intranasal Spray
15982130|NCT03020485|Other|Isomaltulose|Isomaltulose is a disaccharide made up of one molecule glucose and fructose with a (α1-6) linkage.
15982131|NCT03020485|Other|Sucrose|Sucrose is normal table sugar
15982133|NCT03020459|Procedure|peeling-reposition|"After dying with Brilliant Blue G (BBG, Brilliant Blue; Gender, Germany), a horizontal ILM strip is peeled off in inferior quadrant of macular area. Then the ILM was peeled from inferior to superior area continuously. The ILM roll  was unfolded with assistance of perfluoro-n-octane (PFO). Finally, the position of the fixed ILM flap is adjusted under PFO bubble using flute needle or forceps.This was followed by a complete fluid-gas exchange using 14% perfluoropropane gas.Patients are introduced to maintain facedown position for two weeks postoperatively."
15982134|NCT03020459|Procedure|peeling|After dying with Brilliant Blue G (Brilliant Blue; Gender, Germany), a horizontal ILM strip is peeled off in inferior quadrant of macular area. Then, the strand of ILM was peeled off radially from the foveal center to vascular arcade. In result, a round -shaped with 2.5-3.5 disc diameter ILM -peeled area was created.This was followed by a complete fluid-gas exchange using 14% perfluoropropane gas. Patients are encourage to maintain facedown position for two weeks postoperatively.
15982135|NCT03020459|Drug|Brilliant Blue G|We intravitreal injected 0.1ml of Brilliant Blue G (Brilliant Blue; Gender, Germany) to dye ILM before ILM peeling.
15982136|NCT03020459|Other|postoperative posture|Patients of both two groups need to keep prone position for two weeks after the operation.
15982137|NCT03020459|Device|Constellation 23-gauge vitrectomy system|All surgical procedures are operated on the Constellation 23-gauge vitrectomy system (Alcon Laboratories Inc, Fort Worth, TX).
15982138|NCT03020446|Device|Sorbion Dressing|Sorbion dressing will be placed on venous leg ulcer and changed weekly for 4 weeks
15982139|NCT03020433|Device|rTMS Contralesional M1|1Hz Contalesional M1 repetitive transcranial magnetic stimulation (1500 pulses, 25 minutes, 90% AMT
15982140|NCT03020433|Device|rTMS Contralesional PMC|5Hz Contralesional PMC repetitive transcranial magnetic stimulation (1500 pulses, 10 minutes, 5 trains of 300 pulses each with 1 minute rest in between, 90% AMT)
15982141|NCT03020433|Device|rTMS Ipsilesional PMC|5HZ Ipsilesional PMC repetitive transcranial magnetic stimulation (1500 pulses, 10 minutes, 5 trains of 300 pulses each with 1 minute rest in between, 90% AMT)
15982142|NCT03020433|Device|rTMS sham at Ipsilesional M1|1Hz Ipsilesional M1 sham repetitive transcranial magnetic stimulation (1500 pulses, 25 minutes, 50% MSO)
15982143|NCT03020420|Other|Cicatricell Cream|Cream to be applied 2 times a day for 8weeks to 6 months
15982144|NCT03020407|Procedure|IVC Ultrasound-guided|IVC is identified in longitudinal section in the subcostal area of a patient using the curvilinear probe of standard ultrasound. The selected area of IVC diameter measurement is set at 2 centimeters distal to the confluence of hepatic vein by M-mode coupled by two-dimensional mode on frozen screen images using the Sonosite® X-porte.
15982145|NCT03020407|Drug|Antibiotics|Prompt empirical antibiotics will be given to the patients within one hour before the treatment allocation.
15982146|NCT03020407|Drug|Vasopressor|The threshold to the need of a vasopressor is set at mean arterial pressure below 65 mmHg if a patient's condition does not response to the fluid therapy.
15982147|NCT03020368|Biological|Leeches|
15982148|NCT03020368|Drug|Diclofenac|
15982149|NCT03020355|Procedure|Placental Blood Drainage|Immediately after vaginal delivery, after clamping and cutting the cord-the cord will unclamped and the blood will drained until the flow ceased.
15982150|NCT03020355|Procedure|not Placental Blood Drainage|In the control group, the clamped cord will not released.
15982151|NCT03020329|Drug|Paclitaxel liposome|"Patients receive paclitaxel liposome(135mg/m2 on day 1),cisplatin (75mg/m2 Separate injection on day 1 to 3) and 5-fluorouracil (3750mg/m2 CIV 120h ) every three weeks for three cycl es before the radiotherapy.
~Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
~Radical radiotherapy:Intensive modulate radiotherapy (IMRT),total dose for nasopharynx and nodule of neck:60Gy/30F,2.0Gy/daily."
15982152|NCT03020329|Drug|Cisplatin|Cisplatin (75mg/m2 Separate injection on day 1 to 3) with Paclitaxel liposome and 5-fu every three weeks for three cycles before the radiotherapy.Cisplatin(100mg/m2) every three weeks for three cycles during radiotherapy.
15982153|NCT03020329|Drug|5-fu|Fluorouracil (3750mg/m2 CIV 120h)with Paclitaxel liposomeand cisplatin every three weeks for three cycles before the radiotherapy.
15982154|NCT03020329|Radiation|Radical radiotherapy|Intensive modulate radiotherapy (IMRT) will be implement,total dose for nasopharynx and nodule of neck:60Gy(Gray)/30F(Fraction),2.0Gy/daily,5 days/week.
15982155|NCT03020316|Behavioral|Peer Mentor|A volunteer with a similar disease as the subject
15982156|NCT03020316|Behavioral|Transcendental Meditation|A meditation technique
15982157|NCT03020303|Drug|Spironolactone 25Mg Tablet|Randomized participants will receive a study supply of spironolactone 25 mg tablets. They will be instructed to take 1 tablet daily.
15982158|NCT03020303|Drug|Placebo Oral Tablet|Randomized participants will receive a study supply of placebo tablets with no active medical ingredients. They will be instructed to take 1 tablet daily.
15982159|NCT03020290|Device|Endovascular treatment for PAD during medical care (SuperA stent (Abbott))|Long femoropopliteal stenting with SuperA devices during medical care. The endovascular treatment for PAD will be done during the usual medical treatment of patient. The intervention is not carried out within the framework of the research protocol
15982160|NCT03020277|Other|Ecological Momentary Assessment with Smartphone© Application|Filling of the application every 3 days for 6 months by subjects (parents of patients with ASD)
15982161|NCT03020264|Device|glycemic sensor FREESTYLE Libre Pro|Collection of hypoglycemia episodes with glycemic sensor FREESTYLE Libre Pro
15982162|NCT03020251|Other|preoperative chest physiotherapy|preoperative chest physiotherapy : 5 sessions per week during 3 weeks
15982163|NCT03020251|Other|preoperative rehabilitation program|exercise training at home : 5 sessions per week during 3 weeks
15982164|NCT03020238|Procedure|BiClamp group|electric energy
15982165|NCT03020238|Procedure|water jet group|water jet energy
15982166|NCT03020225|Dietary Supplement|White cheese|animal protein food source: White cheese (contains 30g protein), intact, plus 250ml mineral water
15982167|NCT03020225|Dietary Supplement|Green peas|Green peas (contains 30g protein), intact, cooked, plus 250ml mineral water
15982168|NCT03020225|Dietary Supplement|Mankai|Wolffia globosa (Mankai, contains 30g protein), intact, cooked, plus 250ml mineral water
15982169|NCT03020212|Drug|Oxygen|The subjects will be randomly assigned to receive or not LTOT and they will be followed for 30 months. At baseline and then at 10, 20 and 30 months, they will be clinically evaluated with arterial blood gases, pulse oximetry, echocardiography, spirometry with bronchodilator, diffusion capacity, quality of life (SGRQ), neurocognitive performance (MMSE) and six minutes walk test. The primary outcome will evaluate the ratio of occurrence of erythrocytosis or pulmonary hypertension. Secondary outcomes will be evaluated quality of life, lung function, neurocognitive performance and exercise tolerance by comparing the groups with and without LTOT.
15982170|NCT03020199|Biological|Secukinumab|Secukinumab (AIN457) 300 mg will be administered in an open-label fashion according to label as 2 s.c. injections of secukinumab 150 mg (1-mL liquid formulation in a pre-filled syringe). Each 300-mg dose will be provided as 2 pre-filled syringes of 150-mg secukinumab in a single box. Each syringe is labeled as AIN457 150 mg/1 mL.
15982171|NCT03020199|Radiation|nbUVB|Narrow-band UVB applied in 1 or 2 cycles, each comprising a period of 12 weeks with 2 to 3 treatment sessions per week totaling 24 to 36 sessions per cycle. The application will be performed according to the investigational site's protocol, taking into account the patient's skin type. A maximum dose of 3 J/cm2 on the body and 1 J/cm2 on the face is recommended
15982172|NCT03020199|Biological|Secukinumab|Secukinumab (AIN457) 300 mg will be administered in an open-label fashion according to label as 2 s.c. injections of secukinumab 150 mg (1-mL liquid formulation in a pre-filled syringe). Each 300-mg dose will be provided as 2 pre-filled syringes of 150-mg secukinumab in a single box. Each syringe is labeled as AIN457 150 mg/1 mL
15982323|NCT03019250|Dietary Supplement|Colostrum|Enteral colostrum 20g/day powdered colostrum to be mixed in with water and given via nasogastric tube q4 hrs.
15982173|NCT03020199|Biological|Secukinumab|Secukinumab (AIN457) 300 mg will be administered in an open-label fashion according to label as 2 s.c. injections of secukinumab 150 mg (1-mL liquid formulation in a pre-filled syringe). Each 300-mg dose will be provided as 2 pre-filled syringes of 150-mg secukinumab in a single box. Each syringe is labeled as AIN457 150 mg/1 mL
15982174|NCT03020199|Biological|Secukinumab|Secukinumab (AIN457) 300 mg will be administered in an open-label fashion according to label as 2 s.c. injections of secukinumab 150 mg (1-mL liquid formulation in a pre-filled syringe). Each 300-mg dose will be provided as 2 pre-filled syringes of 150-mg secukinumab in a single box. Each syringe is labeled as AIN457 150 mg/1 mL
15982175|NCT03020199|Drug|Calcipotriol|Its a topical treatment for Psoriasis. the concentration it is used is 50mcg/g
15982176|NCT03020199|Drug|Betamethasone|this is topical cream which is used in 0.5mg/g concentration
15982177|NCT03020186|Other|Physical activity|
15982178|NCT03020186|Other|Physical activity+ MED diet|
15982179|NCT03020186|Other|Physical activity+green MED diet|****Sub-study from all 3 main arms: Autologous fecal microbiota supplement intervention derived from the time of maximal weight loss: At the 6-month time period, the time of anticipated greatest weight reduction, participants's feces samples will be processed to capsulized inocula. Samples will be frozen within 2 hours and will be kept at -80c pending analysis. Participants will be randomized to receive either research capsules or identical placebo capsules between 8 and 14 months time period. Placebo capsules will consist of a combination of powdered cocoa and vegetable gelatin in normal saline/glycerol and will be identical in appearance to research capsules.
15982180|NCT03020173|Other|Laboratory study|Laboratory analysis to determine composition of granulosa and oocytes
15982181|NCT03020160|Drug|Emicizumab|Emicizumab will be administered according to dose and schedule described in respective arms. Upon implementation of protocol Version 5, treatment duration will be extended. During this study prolongation, participants will have the opportunity to switch to a preferred emicizumab dosing regimen (1.5 mg/kg weekly, 3 mg/kg every 2 weeks, or 6 mg/kg every 4 weeks) in order to provide them the same flexibility as with commercial product.
15982182|NCT03020134|Drug|Ravidasvir|Ravidasvir tablet administered orally 200mg QD on day 1, 13 - 23
15982183|NCT03020134|Drug|Danoprevir|Danoprevir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23
15982184|NCT03020134|Drug|Ritonavir|Ritonavir tablet administered orally 100mg QD on day 7 and 13, 100mg BID on day 14-22, 100mg QD on day 23
15982185|NCT03020134|Drug|Placebo|Placebo
15982186|NCT03020121|Procedure|Colposcopy/biopsy|Colposcopy/biopsy will be performed on all subjects
15982187|NCT03020108|Other|Blood sample|2 cc blood samples will be drawn from antecubital vein
15982188|NCT03020095|Drug|Ravidasvir|Ravidasvir 200mg tablet administered orally once daily
15982189|NCT03020095|Drug|Danoprevir|Danoprevir 100mg tablet administered orally twice daily
15982190|NCT03020095|Drug|Ritonavir|Ritonavir 100mg tablet administered orally twice daily
15982191|NCT03020095|Drug|Ribavirin|Ribavirin(RBV)1000/1200 mg/day (bodyweight<75/≥75 kg)administered orally
15982192|NCT03020082|Drug|Danoprevir|Danoprevir (DNV)administered orally 100mg BID for 12 weeks;
15982193|NCT03020082|Drug|Ritonavir|Ritonavir administered orally 100mg BID for 12 weeks;
15982194|NCT03020082|Drug|peginterferon alfa-2a|PEG-IFN abdominal or thigh subcutaneous injection, 180μg, once a week for 12 weeks;
15982195|NCT03020082|Drug|RBV|RBV administered orally 500mg (5 tablets)( body weight <75Kg) BID, 600mg (6 tablets) BID body weight ≥75Kg, for 12 weeks.
15982196|NCT03020069|Device|CGMS Device|
15982197|NCT03020069|Other|No Device|
15982198|NCT03020056|Drug|Phacolin eye drops|After enrollment, the participants will be provided antioxidant eye drops, Phacolin (Zhongshan ophthalmic center, China) for free.The eye drops will be administered 4 times per day for 1 year.Then either phacoemulsification or manual small incision cataract surgery will be performed.
15982199|NCT03020056|Procedure|cataract surgery|After enrollment,either phacoemulsification or manual small incision cataract surgery will be performed within 4 weeks.
15982200|NCT03020030|Drug|Pegaspargase|Arm A: Standard/Fixed Dose Pegaspargase (2500 IU/m2 every 2 weeks) Arm B: Reduced Dose (PK-adjusted) Pegaspargase (Starting Dose: 2000 IU/m2) Arm X: Directly Assigned Standard Dose (2500 IU/m2): For all VHR and patients who decline randomization
15982201|NCT03020030|Drug|Erwinia asparaginase|Only for patients with Pegaspargase allergy or silent inactivation.
15982202|NCT03020030|Drug|Cyclophosphamide|Standard of Care
15982203|NCT03020030|Drug|CYTARABINE|Standard of Care
15982204|NCT03020030|Drug|DASATINIB|Standard of Care
15982205|NCT03020030|Drug|DEXAMETHASONE|Standard of Care
15982206|NCT03020030|Drug|Dexrazoxane|Standard of Care
15982207|NCT03020030|Drug|Doxorubicin|Standard of Care
15982208|NCT03020030|Drug|ETOPOSIDE|Standard of Care
15982209|NCT03020030|Drug|HYDROCORTISONE|Standard of Care
15982210|NCT03020030|Drug|LEUCOVORIN CALCIUM|Standard of Care
15982211|NCT03020030|Drug|MERCAPTOPURINE|Standard of Care
15982212|NCT03020030|Drug|METHOTREXATE|Standard of Care
15982213|NCT03020030|Drug|NELARABINE|Standard of Care
15982214|NCT03020030|Drug|Vincristine|Standard of Care
15982215|NCT03020017|Other|Laboratory Biomarker Analysis|Correlative studies
15982216|NCT03020017|Other|Pharmacological Study|Correlative studies
15982217|NCT03020017|Drug|Targeted Molecular Therapy|Given NU-0129 IV
15982218|NCT03020004|Drug|Danoprevir|Danoprevir (DNV) 100mg tablet administered orally twice daily
15982219|NCT03020004|Drug|Ritonavir|Ritonavir 100mg tablet administered orally twice daily
15982220|NCT03020004|Drug|peginterferon alfa-2a|PegIFN subcutaneous injection at 180 mcg weekly
15982221|NCT03020004|Drug|Ribavirin (RBV)|Ribavirin (RBV)1000/1200 mg/day (bodyweight<75/≥75 kg)
15982222|NCT03019991|Drug|Danoprevir|Danoprevir(DNV)administered orally 100mg QD on day 1, day 4 and day 14; 100mg BID on day 5 -day 13
15982223|NCT03019991|Drug|Ritonavir|Ritonavir administered orally 100mg QD on day 4 and day 14; 100mg BID on day 5 -day 13
15982224|NCT03019991|Drug|Placebo|ASC 08 Placebo administered orally 100mg QD on day 1, day 4 and day 14; 100mg BID on day 5 -day 13
15982324|NCT03019250|Dietary Supplement|Maltodextrin|Maltodextrin mixed with water given via NG tube Q 4 hours.
15982225|NCT03019978|Other|PCAMS assessments|This is a longitudinal study, where data will be collected from 54 individuals who are already enrolled in Pennsylvania's ACAP program. Participants will be required to complete online assessments at baseline and then quarterly over a two-year time period.
15982226|NCT03019965|Drug|Intermittent Piperacillin/tazobactam|Piperacillin/tazobactam administered in 30 minutes infusion.
15982227|NCT03019965|Drug|Continuous Piperacillin/tazobactam|Piperacillin/tazobactam administered in 24 hours infusion.
15982228|NCT03019965|Drug|Intermittent Imipenem|Imipenem administered in 60 minutes infusion.
15982229|NCT03019965|Drug|Extended Imipenem|Imipenem administered in 6 hours infusion.
15982230|NCT03019965|Drug|Intermittent Meropenem|Meropenem administered in 60 minutes infusion.
15982231|NCT03019965|Drug|Extended Meropenem|Meropenem administered in 8 hours infusion.
15982232|NCT03019952|Behavioral|Care Coordination Visit|This is a longitudinal study. Adolescents or young adults with autism will participate in this study. Participants will be required to complete a baseline of assessment measures at enrollment and then monthly assessments (described in the study procedures below) during the first (approximately) 10-15 minutes of each visit with the t-CARE coordinator. The remainder of the visit will focus on care coordination and clinical treatment goals.
15982234|NCT03019926|Biological|Hydroxychloroquine dosage|Blood sample from a 6 ml tube, performed in the common practice.
15982235|NCT03019913|Other|Observational cohort|Evaluation of bedside methods to measure muscularity in critically ill patients
15982236|NCT03019900|Procedure|Red blood cells transfusions|The survey was designated to assess the practices of blood transfusion, specifically about the threshold and factors that can modify this threshold.
15982237|NCT03019887|Drug|reduction of risperidone, haloperidol, olanzapine, quetiapine, aripiprazole, paliperidone, levomepromazine, perphenazine|
15982238|NCT03019874|Dietary Supplement|Cranberry Extract|3 x Cystorenal Cranberry plus daily for 6 months (contains 300 mg Cranberry-Extract, 100 mg Pumpkin seeds-Extract, 20 mg Vitamin C und 0,47 mg Riboflavin)
15982239|NCT03019861|Behavioral|Ayurvedic nutritional counseling|
15982240|NCT03019861|Behavioral|Conventional nutritional counseling|
15982241|NCT03019848|Dietary Supplement|Curcumin|
15982242|NCT03019848|Other|Placebo|
15982243|NCT03019835|Drug|Neostigmine (40 mcg / kg) at different time of neuromuscular block's recovery|
15982244|NCT03019835|Other|Spontaneous recovery|just measuring the Train Of Four at 3 6 9 12 and 15 minutes and measure the Train Of Four Ratio
15982245|NCT03019822|Drug|LSD|100ug per os, single dose
15982246|NCT03019822|Drug|MDMA|125mg per os, single dose
15982247|NCT03019822|Drug|Amphetamine|40.3mg per os, single dose
15982248|NCT03019822|Drug|Placebo|Capsules containing mannitol looking identical to the other drugs
15982249|NCT03019809|Biological|G-CSF for Conditioning before HSCT.|Mobilization of hematopoietic stem (HSC) into circulation
15982250|NCT03019809|Biological|Plerixafor for Conditioning before HSCT.|Directed inhibition of CXC chemokine receptor type 4 (CXCR4) for opening enough BM niches for adequate donor HSC engraftment.
15982251|NCT03019796|Drug|MEDICATION AND EXERCISE TRAINING|"PARTICIPANTS WILL BE (IN A RANDOMIZED BLINDED FASHION) WITHDRAWN OF THEIR HYPERTENSIVE MEDICATION (I.E., PLACEBO) IN ONE OCCASION AND TESTED WITH THEIR MEDICATION IN ANOTHER, WITH A WEEK WASHOUT PERIOD.
~THIS TESTING WILL BE REPEATED AFER 4 MONTHS OF EXERCISE TRAINING (48 SESSIONS OF 43 MIN EACH ONE)."
15982252|NCT03019783|Drug|Atazanavir|The active group will switch from a non-atazanavir regimen to an atazanavir-based regimen.
15982253|NCT03019783|Other|Placebo|The control group will stay on their baseline regimen
15982254|NCT03019770|Behavioral|PrEP Decision Aid|All participants will participate in a simulated or actual clinical visit with a healthcare provider. During this visit, they will review the Decision Aid which will give them an HIV risk score and ask questions about their values. The goal of these visits will be to make an informed decision about whether or not to begin using PrEP.
15982255|NCT03019757|Radiation|DaTscan|A functional imaging of the dopamine transporter using the radioligand [123I]FP-CIT
15982256|NCT03019757|Radiation|F18-AV-45|A brain scan to to measure the extent of amyloid deposition
15982257|NCT03019757|Radiation|FDG-PET|a brain scan measuring total and regional cerebral glucose metabolism wtih positron emission tomographs with 2-(18F)
15982258|NCT03019757|Genetic|APOE genotype|10 ml of whole blood will be drawn and shipped to Athena Diagnostics for genetic testing.
15982259|NCT03019757|Procedure|Polysomnogram|Overnight sleep study
15982260|NCT03019757|Behavioral|Clinical Assessment|Clinical assessments include cognitive, behavioral, and motor evaluations
15982261|NCT03019744|Device|MeCFES-assisted task-oriented upper limb rehabilitation|
15982262|NCT03019744|Other|Usual Care task-oriented upper limb rehabilitation|
15982263|NCT03019731|Behavioral|Therapist-directed Behavioral Therapy|The therapist-directed behavioral therapy group will have their first appointment scheduled within one week of assignment. In the Therapist-directed face-face training program, training instructions will be manualized, in order to match the parent instructional guidelines provided in the home-based DVD. This manual will include the specific psychoeducation, awareness training, competing response training, differential reinforcement of incompatible behaviors, and other adaptive behavioral instructions contained within the home-based DVD. The therapist will match the sequence and required components within the behavior-based training DVD. Face-face training will be administered across 10 weeks (6 weekly sessions followed by 2 bi-weekly sessions).
15982264|NCT03019731|Behavioral|Home-based DVD Therapy|In order to mimic the slight delay between randomization and start of the therapist-directed treatment, those assigned to the Home-based DVD cohort will have the DVD and training materials mailed to their homes. Parents will also receive a written instructional form and a log sheet for tracking the use of the DVD and the time and duration of practice sessions. Any questions regarding patient care and treatment will be directed to Dr. Singer.
15982265|NCT03019718|Other|GSA-Online plus|A 12-week online writing intervention based on the Core Conflictual Relationship Theme Method (CCRT) with feedback provided by online therapists.
15982266|NCT03019705|Other|Observation|
15982267|NCT03019666|Biological|Nicotinamide Expanded Haploidentical or Mismatched Related Donor Natural Killer Cells|"Cyclophosphamide 40 mg/kg x 1 day on Day -5
~Fludarabine 25 mg/m^2 x 3 days (Day -5, Day -4, day-3)"
15982268|NCT03019653|Drug|ANX-042|The first 20 subjects will receive a dose 0.003 µg/kg/min by infusion, the next 20 subjects will receive a dose of 0.006 µg/kg/min, then the next 20 subjects will receive 0.01 µg/kg/min.
15982269|NCT03019653|Drug|Placebo|The pharmacy created a placebo for this study is sterile Dextrose (5%) solution (D5W) 0.9% Sodium Chloride for intravenous administration to match study drug.
15982270|NCT03019640|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo stem cell transplant
15982271|NCT03019640|Drug|Carmustine|Given IV
15982272|NCT03019640|Biological|Cord Blood-derived Expanded Allogeneic Natural Killer Cells|Given IV
15982273|NCT03019640|Drug|Cytarabine|Given IV
15982274|NCT03019640|Drug|Etoposide|Given IV
15982275|NCT03019640|Biological|Filgrastim|Given SC
15982276|NCT03019640|Drug|Lenalidomide|Given PO
15982277|NCT03019640|Drug|Melphalan|Given IV
15982278|NCT03019640|Biological|Rituximab|Given IV
15982279|NCT03019627|Drug|NGF|Eye Drop 20 μg/mL
15982280|NCT03019627|Other|Vehicle|Vehicle Eye Drop
15982281|NCT03019614|Drug|Hydrocortisone|Generic hydrocortisone
15982282|NCT03019614|Drug|Chronocort|Modified formulation of hydrocortisone
15982283|NCT03019601|Behavioral|Group Education|Structured group education on family planning facilitated by Peer Champions
15982284|NCT03019588|Biological|Pembrolizumab|IV infusion
15982285|NCT03019588|Drug|Paclitaxel|IV infusion
15982286|NCT03019575|Drug|Corifollitropin alfa|CFA administered 100 μg (if body weight ≤60 kg) or 150 μg (if body weight >60 kg) by SC injection, once every 2 weeks for 64 weeks (Day 1, Week 0 through Week 64).
15982287|NCT03019575|Drug|hCG|hCG 500-5000 IU reconstituted with 1 ml of 0.9% sodium chloride solution, as a SC injection twice a week for 52 weeks (last day of Week 12 through Week 64).
15982288|NCT03019562|Drug|Oxycodone|4mg of oxycodone iv 20 min before the end of surgery, 10ug/kg of fentanyl in Patient-Controlled Analgesia(PCA)
15982289|NCT03019562|Drug|Fentanyl|50ug of fentanyl iv 20 min before the end of surgery, 10ug/kg of fentanyl in Patient-Controlled Analgesia(PCA),
15982290|NCT03019549|Drug|Lanabecestat|Administered orally
15982291|NCT03019549|Drug|Rosuvastatin|Administered orally
15982292|NCT03019536|Drug|LY3303560 - IV|Administered IV
15982293|NCT03019536|Drug|Placebo - IV|Administered IV
15982294|NCT03019536|Drug|Florbetapir F 18|Administered IV during the Positron Emission Tomography (PET) scan performed during screening.
15982295|NCT03019536|Drug|Flortaucipir F18|Administered IV during the PET scan performed during the study.
15982296|NCT03019523|Dietary Supplement|Caffeine Blend|Taken orally in capsule form
15982297|NCT03019523|Other|Sugar Pill|Taken orally in capsule form
15982303|NCT03019484|Behavioral|Breastfeeding support|Self-efficacy
15982304|NCT03019471|Genetic|Isolation of tumor DNA|
15982305|NCT03019458|Dietary Supplement|MINGO|6 20oz sachets will be taken daily by intervention group
15982306|NCT03019432|Behavioral|Observational clinical assessment|perception of verticality measures SVV and SPV; somatosensory assessment RASP
15982307|NCT03019419|Drug|Perampanel|4mg/d or 8mg/d
15982308|NCT03019419|Drug|placebo|placebo
15982309|NCT03019406|Drug|avalglucosidase alfa GZ402666|Pharmaceutical form: powder for concentrate for solution for infusion Route of administration: intravenous
15982310|NCT03019406|Drug|alglucosidase alfa GZ419829|Pharmaceutical form: powder for concentrate for solution for infusion Route of administration: intravenous
15982311|NCT03019393|Other|Beef|200 g beef topside which is fully cooked will be provided to participant after overnight fast. The intervention is one time only.
15982312|NCT03019380|Device|removing cerumen from external ear (Wondertip)|The wondertip will be coiled into the external ear canal with the purpose of grasping and evacuating the cerumen. Following the evacuation, the depth of the external ear canal will be messured.
15982313|NCT03019367|Procedure|Umbilical cord milking UCM|At delivery, the umbilical cord is grasped, and blood is pushed toward the infant 4 times before it is clamped. This procedure infuses a placental transfusion of blood into the preterm neonate and can be done in 15-20 seconds.
15982314|NCT03019367|Procedure|Delayed cord clamping DCC|At delivery, delayed cord clamping will be performed by having the delivering obstetrician delay clamping of the umbilical cord for at least 60 seconds.
15982315|NCT03019354|Device|high-flow nasal oxygen|Using high-flow nasal oxygen 10 L/min before anesthesia induction, then using high-flow nasal oxygen 30-50 L/min during intravenous general anesthesia.
15982316|NCT03019354|Device|Oxygen mask|Using oxygen mask with oxygen flow 10 L/min before and during intravenous general anesthesia.
15982317|NCT03019328|Other|Peanut in diet|
15982318|NCT03019302|Device|Arrow PICC with Chloragard Technology|chlorhexidine is chemically bonded to the intra- luminal catheter surfaces from tip to hub, and extra-luminal catheter body
15982319|NCT03019289|Drug|pridopidine (90 mg)|single dose will be administered in Cohort 1. Other optional cohorts 2 and 3 may include single dose 0.5 mg, 1 mg, 2.5 mg, 5 mg, 10 mg, 22.5 mg, 45 mg, or 67.5 mg. The dose will be selected based on the results obtained from Cohorts 1 and 2.
15982320|NCT03019276|Drug|TQ-B3101|Escalating doses of TQ-B3101 will be administered orally on a continuous dosing schedule. Doses to be evaluated will range from 100 mg to 500 mg/day administered either once or twice a day. A treatment cycle is considered to be 28 days .
15982321|NCT03019263|Dietary Supplement|Nutraceutical|Nutritional counseling plus one pill of an active product (Trixy®) containing Berberine, Tocotrienols and Chlorogenic acid
15982328|NCT03019224|Procedure|Selection and preparation of the volunteers|Patients who sought the postgraduate dental clinic for whitening were invited to participate in the study. They were informed by the researcher (dentist) about all the aspects of the study and who might participate or discontinue the participation at any moment during the treatment. In addition, it was clarified that their participation was voluntary and refusal to participate would not result in any penalty or loss of benefits.
15982329|NCT03019224|Procedure|Evaluation of the tooth color|"The evaluation of the tooth color was performed by using a spectrophotometer (Easyshade, Vident, Brea, CA, USA). The color was analysed with the tooth hydrated before of the start the first whitening session and one week after.
~The spectrophotometer was always used in the same position by a silicon guide, which was prepared with dental arch molds by adding high viscosity vinyl polysiloxane material (Express XT, 3M ESPE, Sumaré, SP, Brazil). After polymerization, an opening was made in the mold corresponding to the buccal surface of the upper central incisors, allowing the color of the tooth to be evaluated with the tip of the spectrophotometer at the height of the middle third."
15982330|NCT03019224|Procedure|Relative isolation|The clinical procedures were performed under relative isolation using lip retractor (Arcflex, FGM, Joinville, SC, Brazil) and dental cotton rollers to apply a gingival protection barrier (Top Dam, FGM, Joinville, SC, Brazil) extending from right first molar to left first molar in both arches.
15982331|NCT03019224|Procedure|Gingival protection barrier|The gingival protection barrier was placed over the margins and gingival papilla corresponding to the areas receiving the whitening gel with approximately 3 mm in height and photopolymerized for 20 seconds in each group of three tooth. Photo-activation was performed with high power LEDs (light intensity = 600mw / cm²) (RadiiCal, São Paulo, SP, Brazil).
15982332|NCT03019224|Procedure|Application of desensitizing gel|The desensitizing gel containing 5% potassium nitrate associated with 2% sodium fluoride (Desensibilize KF 2%, FGM, Joinville, SC, Brazil) was applied with a microbrush (Brush KG, KG Sorensen, Cotia, SP) on the buccal surface from right first molar to left first molar in both arches and remaining for 10 minutes. Then, the desensitizer was then removed with water jet and disposable plastic suction cannula.
15982333|NCT03019224|Drug|Hydrogen peroxide|The handling of 35% hydrogen peroxide (Whiteness HP, FGM, Joinville, SC, Brazil) followed the manufacturer's recommendations, which consisted of mixing 3 drops of 35%hydrogen peroxide for 1 drop of thickener, with this mixture being sufficient for application to at least three tooth. The gel remained in contact with the buccal surface of the tooth for 15 minutes and was removed with disposable plastic suction cannula and water wash. This procedure was performed three times per clinical session. The volunteers underwent three whitening clinical sessions with one week interval between them.
15982334|NCT03019224|Procedure|Used a dentifrice|Among the clinical whitening sessions, each volunteer used an unidentified dentifrice corresponding to their experimental group, which was previously defined by means of a draw made by a dentist who did not participate in the study. Thus, the researcher (dentist) who provided the dentifrice and the volunteer were not aware of which experimental group belonged (i.e. double blind).
15982335|NCT03019211|Other|Exercise|
15982336|NCT03019198|Drug|Tranexamic Acid Injectable Solution|Intravenous 15 mg per kilogram tranexamic acid
15982337|NCT03019198|Drug|Placebo - Concentrate|
15982338|NCT03019185|Drug|Placebo Oral Capsule|Capsule containing an inert placebo
15982339|NCT03019185|Drug|Bardoxolone Methyl|Bardoxolone methyl dose escalated from 5 mg to a maximum of 20 or 30 mg, depending on baseline proteinuria status.
15982340|NCT03019172|Combination Product|Lactobacillus reuteri|Sachet one contains a total of 5*10^8 CFU of Lactobacillus reuteri DSM 16666 & Lactobacillus reuteri DSM 17938, mixed with maltodextrin for flowability during production. Sachet two contains instant cranberry drink composed of Cranberry extract, xylitol, cranberry aroma, monosodium citrate, zink gluconate, silica. The products will be taken twice per day, morning and evening. The daily dose in the active group will be at least 5*10^8 CFU of L.reuteri DSM16666 and L. reuteri DSM17938), PAC-A and zinc
15982341|NCT03019172|Dietary Supplement|Sachet with cranberry + placebo|Sachet one contains placebo for probiotics (maltodextrin). Sachet two contains instant cranberry drink composed of Cranberry extract, xylitol, cranberry aroma, monosodium citrate, zink gluconate, silica.
15982342|NCT03019159|Device|Teleconsulting|
15982343|NCT03019146|Other|HIIT|
15982344|NCT03019146|Other|HOLD|
15982345|NCT03019146|Other|HUG|
15982346|NCT03019133|Device|Sound reduction|Subjects will wear noise reduction headphones between the hours of 8:00 pm and 8:00 am.
15982347|NCT03019133|Device|Sound masking|Subjects will wear wear headphones playing relaxing music between the hours of 8:00 pm and 8:00 am.
15982348|NCT03019120|Drug|Vitamin D|"Subjects will undergo a cognitive evaluation using the Montreal Cognitive Assessment (MoCA) screening test and the Neurotrax computerized cognitive assessment battery.
~Subjects will receive a supplemental monthly oral dose of 60000 units Vitamin D administered by a nurse for a period of 3 months.
~Levels of serum calcium will be repeated monthly (end of month 1, 2, 3).
~Subjects will undergo a repeat blood test to examine the level of vitamin D at the end of 3 months of follow-up.
~At 3-month follow-up subjects will be asked to complete the Neurotrax computerized cognitive assessment battery."
15982349|NCT03019094|Device|The RENOVA tibial nerve stimulation system|Study participants will be implanted with the RENOVA tibial nerve stimulation system
15982350|NCT03019081|Drug|Isoproterenol|The goal of this experiment is to use isoproterenol in the context of inhibitory fear learning to reduce eating-related anxiety in AN, and to explore whether these changes are related to interoceptive awareness and autonomic reactivity.
15982351|NCT03019081|Other|placebo|placebo
15982352|NCT03019055|Biological|CAR-20/19-T cells (1.0 x10^5 CAR-20/19-T cells/kg)|"CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.
~Phase 1 Dose Level 0: 2.5 x10^5 CAR-20/19-T cells/kg (starting dose level)"
15982353|NCT03019055|Biological|CAR-20/19-T cells (2.5 x10^5 CAR-20/19-T cells/kg)|"CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.
~Phase 1 Dose Level 1: 7.5 x10^5 CAR-20/19-T cells/kg"
15982354|NCT03019055|Biological|CAR-20/19-T cells (7.5 x10^5 CAR-20/19-T cells/kg)|"CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.
~Phase 1 Dose Level 2: 2.5 x10^6 CAR-20/19-T cells/kg (goal cell dose)
~Phase 1b Expansion Dose Level: 2.5 x 10^6 cells/kg (single infusion)"
15982355|NCT03019055|Biological|CAR-20/19-T cells (2.5 x10^6 CAR-20/19-T cells/kg)|CAR-20/19-T cells will be administered either fresh or thawed after cryopreservation by IV injection.
15982356|NCT03019042|Dietary Supplement|Hou Gu Mi Xi|Hou Gu Mi Xi is a dietary therapy form of Shen Ling Bai Zhu San, of which removes atractylodes and platycodon grandiflorum, adds perilla leaf for adapting a dietary therapy.
15982357|NCT03019042|Other|placebo|The placebo has same appearance, taste and smell as Hou Gu Mi Xi.
15982358|NCT03019029|Other|18-F Florbetapir PET/MR scan|18-F Florbetapir PET/MR scan, PET/MR on a GE SIGNA PET/MR scanner
15982359|NCT03019016|Procedure|Right Colectomy|Robotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to midtransverse colon.
15982362|NCT03018990|Other|Ethanol|1 milliliter per kilogram body weight adjusted for elevated body mass index
15982363|NCT03018977|Other|The sedative weaning protocol group|After physician decide to wean sedative or analgesic drugs. We divided to 2 groups including high risk group and low risk group. The sedative weaning protocol were used in these patients which rely on the high risk or low risk group.
15982364|NCT03018977|Other|The usual group|After physician decide to wean sedative or analgesic drugs. The sedative/analgesic drugs were weaned depend on physician
15982365|NCT03018964|Procedure|Solo surgery|Solo surgery using a camera scope holder in single incision laparoscopic cholecystectomy
15982366|NCT03018964|Procedure|operation with a camera operator in SILC|conventional single incision laparoscopic cholecystectomy with a scopist
15982367|NCT03018951|Other|Tool Development meeting|Consenting participants will be invited to attend up to four meetings concerning the design of the specialist tool to assess frailty in older adults with a diagnosis of functional mental illness. The meetings will be small with up to three participants and the Chief Investigator present. The Chief Investigator will present the group with plans and ideas for the proposed assessment tool and facilitate discussions relating to these ideas. Participants will be encouraged to share their opinions and any ideas they may have. The chief investigator will take written meeting minutes during each session, which will be checked and agreed on by all meeting attendees. Each meeting will last no more than 90 minutes.
15982368|NCT03018951|Other|Pilot Test 1 assessment session|Consenting participants will engage in a one off assessment session where the newly devised specialist tool to assess frailty in older adults with a diagnosis of functional mental illness will be administered. Participants will be asked a series of verbal questions related to frailty indicators and asked to engage in basic observational tests of walking speed and both static and dynamic balance. Qualitative data will be gathered from the participant to establish the comprehensibility, relevance, acceptability and feasibility of the tool via a questionnaire that includes both Likert scales and open ended questions. To assess the comprehensibility of the tool's questions each participant will also be asked to rephrase a subset of the tools questions. The duration of the assessment session will be 90 minutes maximum.
15982369|NCT03018951|Other|Pilot Test 2 assessment session|Consenting participants will engage in a one off assessment session where the revised specialist tool to assess frailty in older adults with a diagnosis of functional mental illness will be administered. The administration of the tool will follow the same process as in pilot test 1. Participants will then be asked to complete a further self-rated frailty assessment tool: the Tilburg Frailty Indicator. Again, following the administration of the tools, qualitative data will be gathered from the participant to establish the comprehensibility, relevance, acceptability and feasibility of the revised tool as per the methods in pilot test 1. The tool will be scored by a study researcher and the study's chief investigator at the same time to assess inter-rater reliability. The duration of the assessment session will be 90 minutes maximum.
15982370|NCT03018938|Drug|Insulin Analog Mid Mixture|Administered SC
15982371|NCT03018938|Drug|Basal Insulin Analog|Administered SC
15982372|NCT03018925|Drug|Golimumab|The treatment followed was an induction of 200 mg of Golimumab at week 0, and 100 mg at week 2. Under 70 Kg, the follow-up treatment dose would be 50 mg/month, and 100 mg/month in patients above 70 Kg asindicated in standard clinical practice.
15982373|NCT03018912|Other|Sleep VS|"During check in patients are instructed to complete the Sleep VS survey packet only. The Sleep VS survey packet will take approximately 4 minutes to complete. The packet includes the subjective Sleep VS and additional sleep questionnaires, such as ESS, FOSQ-10, ISI, and sleep-wake pattern questions.
~The subjective Sleep VS is composed of the following 2 questions:
~How many days a week are you satisfied with your sleep?
~How many days a week is sleepiness a problem?"
15982374|NCT03018899|Procedure|paravertebral block|Ultrasound guided two-segment paravertebral block
15982375|NCT03018899|Procedure|epidural anesthesia|thoracic epidural anesthesia
15982376|NCT03018886|Other|GHRH plus arginine test|One ug/kg GHRH [GHRH(1-29), GEREF Serono, Italy] was administered as an iv bolus at time 0 min, followed by arginine (L-arginine monohydrochloride, Braun, Melsungen, Germany) 0.5 g/kg (max 30g9 over 30 min. Blood samples were drawn at -15,0,15,30,45,60,75,90 min.
15982377|NCT03018873|Other|remote ischemic preconditioning （RIPC）|once RIPC: three five-minute cycles of upper limb ischaemia and three five-minute pauses using a blood pressure cuff inflated to 200 mmHg.
15982378|NCT03018860|Procedure|"Moderate management"|"After randomization, women allocated to the intervention group, i.e. moderate pushing, are encouraged to push only 2 times per contractions, to respect contractions without pushing and there is no limit of pushing duration."
15982379|NCT03018860|Procedure|"Intensive management"|This group corresponds to usual obstetrical management of active second stage in France. In France, national guidelines recommend to limit maternal expulsive efforts to 30 minutes (grade C). Thus, physicians (midwives and obstetricians) encourage usually women to push 3 times per contractions and to push on every contraction in order to deliver into a 30 minutes timing.
15982380|NCT03018847|Device|COPD Co-Pilot|The COPD Co-Pilot is a system that guides a patient through a software application (web or mobile app) to collect, track, and trend daily symptoms related to Chronic Obstructive Pulmonary Disease (COPD). The system is intended to be used by patients as a support tool to track COPD symptoms as part of their personal disease management plan. The COPD Co-Pilot allows health care providers to view and triage subject symptoms via the provider web-based application. Health care providers also have the ability to send responses to subjects, like medication recommendations, through preset forms in the system.
15982381|NCT03018834|Drug|ANAKINRA 100 mg/daily subcutaneously|ANAKINRA 100 mg/daily subcutaneously once a day until hospital discharge, for a maximum of 14 days, in addition to standard care: ACE and Beta-blocker for 6 months.
15982382|NCT03018834|Drug|Placebo|PLACEBO 100 mg/daily subcutaneously once a day until hospital discharge, for a maximum of 14 days, in addition to standard care: ACE and Beta-blocker for 6 months.
15982383|NCT03018821|Drug|Standard - Yinchengao Decoction plus Ganlu Detoxification Pill|Yinchengao Decoction plus Ganlu Detoxification Pill is one Chinese Medicine Formula for the TCM syndrome: Damp-heat blocking middle jiao.
15982384|NCT03018821|Drug|Entecavir or Tenofovir|Western drug for anti-HBV such as Entecavir and Tenofovir
15982385|NCT03018821|Drug|Standard - Ge Xia Zhu Yu Decoction|Ge Xia Zhu Yu Decoction is one Chinese Medicine Formula for the TCM syndrome: internal blood stasis.
15982386|NCT03018821|Drug|Advanced - Supplemented Taohong Huazhuo Decoction|Supplemented Taohong Huazhuo Decoction is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: Damp-heat blocking middle jiao.
15982387|NCT03018821|Drug|Standard - Chaihu Shugan San|Chaihu Shugan San is one Chinese Medicine Formula for the TCM syndrome: Liver depression and qi stagnation.
15982388|NCT03018821|Drug|Advanced - Soothe the liver and regulate qi Decoction|Soothe the liver and regulate qi Decoction is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: Liver depression and qi stagnation.
15982389|NCT03018821|Drug|Standard - Xiaoyao powder|Xiaoyao powder is one Chinese Medicine Formula for the TCM syndrome: Stagnation of liver qi and spleen deficiency.
15982390|NCT03018821|Drug|Advanced - Supplemented Ganbi Decoction|Supplemented Ganbi Decoction is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: Stagnation of liver qi and spleen deficiency.
15982391|NCT03018821|Drug|Standard - Yiguan Decoction|Yiguan Decoction is one Chinese Medicine Formula for the TCM syndrome: Yin deficiency of liver and kidney.
15982392|NCT03018821|Drug|Advanced - Supplemented Zimu Dan|Supplemented Zimu Dan is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: Yin deficiency of liver and kidney.
15982393|NCT03018821|Drug|Standard - Fuzilizhong Decoction plus Jinkui Shenqi Bolus|Fuzilizhong Decoction plus Jinkui Shenqi Bolus is one Chinese Medicine Formula for the TCM syndrome: Yang deficiency of spleen and kidney.
15982394|NCT03018821|Drug|Advanced - Guifu Erxian Decoction|Guifu Erxian Decoction is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: Yang deficiency of spleen and kidney.
15982395|NCT03018821|Drug|Advanced - Supplemented Ganji Decoction|Supplemented Ganji Decoction is one Chinese Medicine Formula suggested by national wide known TCM doctors who expertise in chronic hepatitis B for the TCM syndrome: internal blood stasis.
15982396|NCT03018808|Other|Minimal questionnaire|The minimal questionnaire is a reduced version of the medical interview and it will include questions about sociodemographic information, previous diagnosis of COPD, co-morbidities and smoking habits.
15982397|NCT03018808|Other|Medical interview|Medical interview includes medical history, sociodemographic and clinical information, including disease history, treatment history, smoking habits and use of biomass.
15982398|NCT03018808|Other|CAT|The CAT is a questionnaire for COPD patients and is designed to measure the impact of COPD on a person's life over time.
15982399|NCT03018808|Procedure|Blood test|Blood samples will be collected at indicated time points
15982400|NCT03018808|Other|anthropometric measures|Anthropologic measures will be performed.
15982401|NCT03018808|Other|Oximetry|Digital pulse oximeter on the index finger after five minutes rest and before receiving bronchodilator for spirometry will be used to measure the pulse arterial oximetry. The average of three measurements at 10 second intervals will be recorded. The heart rate will be provided by the pulse oximeter.
15982402|NCT03018795|Procedure|Decontamination of implant surfaces|Decontamination of implant surfaces in combination with regenerative surgery
15982403|NCT03018782|Other|Brief Pain Inventory Short Form|Brief Pain Inventory Short Form
15982404|NCT03018769|Drug|Chinese Herb|
15982405|NCT03018756|Drug|Fentanyl Citrate|100 mcg fentanyl citrate will be inhaled via nebulizer.
15982406|NCT03018756|Drug|Placebo|0.9% saline solution will be inhaled via nebulizer
15982407|NCT03018743|Drug|Dapoxetine|Patients receive dapoxetine (taken 1-3 hours before sexual intercourse) 30mg as needed. A dose escalation to 60mg will be consented after 1 month in case of low efficacy. Patients will be re-evaluated 1, 3, 6, 12, and 24 months after initiating therapy regarding the treatment status and the reasons for treatment discontinuation in the case of discontinuation. If patients missed any visits, they will be contacted by telephone or mail to collect their treatment data.
15982408|NCT03018730|Biological|PRX-102 (pegunigalsidase alfa)|PRX-102 1 mg/kg every 2 weeks
15982409|NCT03018717|Other|Telemonitoring Constant|telemedicine of Constant
15982410|NCT03018717|Other|Standard clinical care|The patient will self-monitor heart rate, blood pressure, weight, diuresis, and capillary glycemia (in the case of diabetes)
15982411|NCT03018704|Drug|Topiramate|anticonvulsant medication
15982412|NCT03018704|Drug|placebo|inactive medication
15982413|NCT03018691|Drug|OPA-15406|
15982414|NCT03018691|Drug|Placebos|
15982415|NCT03018665|Drug|Exenatide|subcutaneous injection，5ug twice a day the first month，10ug twice a day the second and third month
15982416|NCT03018665|Drug|BIAsp30|subcutaneous injection，fit dosage twice a day in three months
15982417|NCT03018665|Drug|Metformin|oral，0.85g，twice a day in three months
15982418|NCT03018652|Drug|Intravenous immunoglobulin|IVIG 0.5 g/kg, up to maximum of 80 grams will be given on the day of randomization and then every 4 ± 1 weeks for 44 weeks (Total 48 weeks)
15982419|NCT03018652|Drug|Normal Saline|5 mL/kg, up to maximum of 800 mL will be given on the day of randomization (this will match the volume of 0.5g/kg of IVIG product) and then every 4 ± 1 weeks for 44 weeks (Total 48 weeks)
15982420|NCT03018639|Behavioral|Dialectical Behavior Therapy|DBT is a cognitive-behavioral treatment program that was developed to treat suicidal Patients with BPD (Linehan, 1993).
15982421|NCT03018626|Drug|Rituximab|rituximab (375 mg/m2) given intravenously (IV) on day 0
15982422|NCT03018626|Drug|Etoposide|Etoposide(50 mg/m2) given continuous intravenously (CIV) from day 1-4(96 hours)
15982423|NCT03018626|Drug|Doxorubicin|Doxorubicin(10 mg/m2) given continuous intravenously (CIV) from day 1-4(96 hours)
15982424|NCT03018626|Drug|Vincristine|Vincristine(0.4 mg/m2) given continuous intravenously (CIV) from day 1-4(96 hours)
15982425|NCT03018626|Drug|Cyclophosphamide|Cyclophosphamide(750 mg/m2)/dayg IV on days 5
15982426|NCT03018626|Drug|Prednisone|prednisone (100 mg) given orally bid on days 1 through to 5.
15982427|NCT03018626|Drug|Doxorubicin|Doxorubicin (75 mg/m2) given intravenously (IV) on day 1,
15982428|NCT03018626|Drug|Cyclophosphamide|Cyclophosphamide (1,200 mg/m2) given intravenously (IV) on day 1,
15982429|NCT03018626|Drug|Vindesine|Vindesine (2 mg/m2) given on days 1 and 5
15982430|NCT03018626|Drug|Bleomycin|Bleomycin (10 mg) given IV on days 1 and 5
15982431|NCT03018613|Other|Fecal Microbiota Transplantation|Fecal Microbiota Transplantation and the traditional treatments for chronic functional constipation in part 1.
15982432|NCT03018613|Other|Normal Saline|Normal saline and the traditional treatments for chronic functional constipation in part 2
15982433|NCT03018600|Behavioral|diet and exercise intervention|consult nutrious doctors giving specific food and take regular exercise when under steroid therapy
15982434|NCT03018587|Device|TruSculpt|Subject(s) will receive 1 Trusculpt (Radio Frequency) Device Treatment
15982435|NCT03018561|Other|Exercise and Cognitive testing|Maximal cardiopulmonary test Rest cognitive testing
15982436|NCT03018548|Other|blood draw|subjects will have blood drawn done. This blood will then be exposed to blasting with CO2 cartridge
15982437|NCT03018535|Drug|Rituximab|Rituximab,1 g IV, day 1 and day 15
15982438|NCT03018535|Drug|Methylprednisolone|Methylprednisolone 1 g IV daily for 3 doses, then oral methylprednisolone (0.4 mg/kg/day) or oral prednisone (0.5mg/kg/day) for 27 days during Month 1, 3, 5.
15982439|NCT03018535|Drug|Cyclophosphamide|Month 2, 4 and 6: Oral Cyclophosphamide (2.0 mg/kg/day) for 30 days
15982440|NCT03018522|Other|Postoperative cognitive dysfunction|Neuropsychological tests of all patients will conduct on the one day prior to surgery, the 7th day after surgery, and the 3rd month after surgery
15982441|NCT03018509|Drug|JTE-451|Active drug tablets containing JTE-451
15982442|NCT03018509|Drug|Placebo|Placebo tablets identical in appearance to the active drug tablets
15982443|NCT03018496|Dietary Supplement|Beta-Hydroxy-Beta-Methylbutyrate|
15982444|NCT03018496|Other|Placebo|
15982445|NCT03018483|Device|Variable PSV|"Pressure support is to a targeted mean tidal volume of 6 to 8 ml/kg; the maximal inspiratory pressure ≤40 cmH2O; the flow trigger is set at 2 l/min; inspiratory cycling-off at 25% of peak flow; PEEP and FiO2 for oxygen saturation SaO2 ≥92%, with PEEP ≥5 cmH2O.
~In patients ventilated with variable PSV, the pressure support variability is as high as possible (up to 100%), while not exceeding the maximal inspiratory pressure determined by the treating physician."
15982446|NCT03018483|Device|Conventional PSV|Pressure support is to a targeted mean tidal volume of 6 to 8 ml/kg; the maximal inspiratory pressure ≤40 cmH2O; the flow trigger is set at 2 l/min; inspiratory cycling-off at 25% of peak flow; PEEP and FiO2 for oxygen saturation SaO2 ≥92%, with PEEP ≥5 cmH2O. The adjustment of pressure support until extubation follows these rules for both non-variable and variable PSV groups: pressure support is gradually adjusted in decrements (or increments) of 0 to 5 cmH2O. PEEP is decreased in steps of 0 to 5 cmH2O; PEEP and FiO2 are adjusted to achieve a SaO2 ≥92%, with a PEEP ≥5 cmH2O.
15982447|NCT03018483|Device|Automated PSV|Pressure support is to a targeted mean tidal volume of 6 to 8 ml/kg; the maximal inspiratory pressure ≤40 cmH2O; the flow trigger is set at 2 l/min; inspiratory cycling-off at 25% of peak flow; PEEP and FiO2 for oxygen saturation SaO2 ≥92%, with PEEP ≥5 cmH2O.Smart CareTM as total automated procedure will be used.
15982448|NCT03018483|Device|NAVA|NAVA level is to a targeted mean tidal volume of 6 to 8 ml/kg; the maximal inspiratory pressure ≤40 cmH2O; the Edi level was increased by step of 0,2 cm/h2o/ mcvolt, PEEP and FiO2 for oxygen saturation SaO2 ≥92%, with PEEP ≥5 cmH2O.
15982449|NCT03018470|Other|Analysis of data from NIV built-in software|Analysis of breathing pattern using data obtained from NIV built-in software
15982450|NCT03018457|Device|ISQ|Measured by Osstell.
15982451|NCT03018444|Drug|Atorvastatin|Atorvastatin tablet
15982452|NCT03018444|Other|Placebo|Placebo tablet
15982453|NCT03018431|Other|CT Scan|patients undergoing chest CT scan at admission and repeated lung ultrasonography
15982454|NCT03018418|Radiation|Proton therapy|Primary target volume 50.4-54 CGE in 28-30 fractions; Nodal volumes 42-54 CGE in 28-30 fractions
15982455|NCT03018418|Drug|Chemotherapy|5FU 1000 mg/m2/day as 96 hour infusion days 1-5 and 29-33; Mitomycin 10mg/m2 days 1 and 29
15982456|NCT03018405|Biological|NKR-2 cells|"In cohorts 1-6, the schedule of administration will be 3 NKR-2 doses administered with a 2-week interval. In absence of progressive disease at the first tumor assessment following NKR-2 administration (on Visit D29 for hematological tumors or on Visit D57 for solid tumors), and according to product availability, the patient will receive a new cycle of 3 administrations maximum with a 2-week interval, at a dose of 1x109 NKR-2 cells per injection, or at the same dose of cycle 1 if it was below 1x109 NKR-2 cells.
~Patients in cohorts 8-9 (solid arm) and 10-11 (hematological arm) of first segment will receive 3 treatment doses at 1x109 NKR-2 (cohorts 8 and 10) or 3x109 NKR-2 (cohorts 9 and 11) per injection, with a 1-week interval between each dose. A second cycle of three NKR-2 injections at the same dose as in 1st cycle will be administered 2 weeks after the third NKR-2 injection, and with a 2-week interval between each dose."
15982457|NCT03018392|Device|Stryker Tritanium Spinal System|open transforaminal lumbar interbody fusion (TLIF) utilizing the Stryker Tritanium cages with pedicle screw fixation according to instructions for use and package labeling for on-label indications
15982458|NCT03018366|Drug|17beta Estradiol|Participants will use a dose of transdermal estradiol 0.1 mg/day patch for 12 weeks +/- 1week. PAT index and sphygmoCor vascular measures and serum immune markers will be measured after 6 and 12 weeks +/- 1week on estrogen patches. Patches will be applied by the participant to the lower abdomen twice weekly, alternating sides.
15982459|NCT03018366|Drug|Transdermal placebo patch|Participants will use a dose of placebo patches for 12 weeks +/- 1 week. Placebos will be applied by the participant to the lower abdomen twice weekly, alternating sides.
15982460|NCT03018366|Drug|Progesterone|After 12 weeks +/- 1week of transdermal estradiol patch, participants will use estrogen patch plus progesterone for 2 additional weeks +/- 3 days. Progesterone 200mg is a peanut based product and for patients with a peanut allergy we will replace this with a synthetic progestin at an equivalent dose, medroxyprogesterone 10mg.
15982461|NCT03018366|Drug|Placebo Pill|After 12 weeks +/- 1week of transdermal placebo patch, participants will use placebo patch plus placebo pill for 2 additional weeks +/- 3 days.
15982462|NCT03018353|Drug|Patients receiving Sof/Vel (Epclusa) and Navigation services|Implementing HCV treatment in the jails using FDA-approved medications and continuing there treatment in the community if they are released during their treatment regimen.
15982463|NCT03018340|Drug|Pimavanserin|Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study.
15982464|NCT03018340|Other|Placebo|Placebo, taken as two tablets, once daily by mouth All patients continued to receive selective serotonin reuptake inhibitor/serotonin norepinephrine reuptake inhibitor (SSRI/SNRI) antidepressants at a stable dose for the duration of the study.
15982465|NCT03018314|Other|Blood sample|Serum analysis
15982466|NCT03018301|Drug|Ketamine|will receive 0.25 mg/kg intravenous ketamine diluted with normal saline to 20 ml delivered over 10 minutes.
15982467|NCT03018301|Other|Normal saline|will receive intravenous 20 ml of normal saline, delivered over 10 minutes.
15982468|NCT03018288|Drug|Pembrolizumab|Pembrolizumab at 200mg will be administered on day 1 as a 30 minute IV infusion (prior to RT) every 3 weeks during RT on days 1, 22 and 43. At one year, if patients are doing well they may continue pembolizumab for 12 more months alone or in conjunction with HSPPC-96 or placebo vaccine if any is available.
15982469|NCT03018288|Biological|HSPPC-96|One week post RT, patients will receive weekly x 4 a dose of HSPPC-96 0.4mL intradermal vaccine or placebo. HSPPC-96 vaccine or placebo will then be given 21 days after the day 5 dose of TMZ. HSPPC-96 vaccine or placebo vaccine will be given for 6 cycles or until supply runs out. Patients who receive placebo will be matched for number of vaccine injections that were generated by their tumor tissue. At one year, if patients are doing well they may continue pembrolizumab for 12 more months alone or in conjunction with HSPPC-96 or placebo vaccine if any is available.
15982470|NCT03018288|Drug|Temozolomide|TMZ will be administered on day 1 of radiation therapy (before RT treatment) and continue throughout RT at the dose of 75 mg/m2. Post RT: The starting TMZ dose will be 150 mg/m2/day for cycle 1, days 1-5, with a single dose escalation to 200 mg/m2/day (days 29-33) and for all subsequent treatment if no treatment-related adverse events greater than Grade 2 are noted. TMZ will be given for 6 cycles.
15982471|NCT03018288|Other|Placebo|One week post RT, patients will receive weekly x 4 a dose of HSPPC-96 0.4mL intradermal vaccine or placebo. HSPPC-96 vaccine or placebo will then be given 21 days after the day 5 dose of TMZ. HSPPC-96 vaccine or placebo vaccine will be given for 6 cycles or until supply runs out. Patients who receive placebo will be matched for number of vaccine injections that were generated by their tumor tissue. At one year, if patients are doing well they may continue pembrolizumab for 12 more months alone or in conjunction with HSPPC-96 or placebo vaccine if any is available.
15982472|NCT03018275|Biological|Roseomonas mucosa|R mucosa grown in Hank's balanced salt solution. Bacteria is washed, quantitated spectrophotometrically, suspended in 10%-15% sucrose, and lyophilized.
15982473|NCT03018262|Device|TMS - sub-study 1|TMS pulses will be applied to the motor hotspot of the surround muscle to identify the TMS-evoked potentials corresponding to motor surround inhibition (SI)
15982474|NCT03018262|Device|TMS - sub-study 2|TMS will be used to stimulate the motor cortex and an inhibitory region of the inferior parietal lobe
15982475|NCT03018262|Device|TMS - sub-study 3|TMS pulses will be delivered to the primary motor cortex at rest, at the onset of the motor task, or during the motor task
15982476|NCT03018249|Drug|Entinostat|Given PO
15982477|NCT03018249|Procedure|Hysterectomy|Undergo hysterectomy
15982478|NCT03018249|Other|Laboratory Biomarker Analysis|Correlative studies
15982479|NCT03018249|Drug|Medroxyprogesterone Acetate|Given IM
15982480|NCT03018236|Drug|Alcohol N-acetylcysteine|1200 mg of NAC per day, taken in two doses, for subjects with alcohol use disorder
15982481|NCT03018236|Drug|Alcohol Placebo|Flour pills looking exactly the same as the active compound, for subjects with alcohol use disorder
15982482|NCT03018236|Drug|Cocaine N-acetylcysteine|1200 mg of NAC per day, taken in two doses, for subjects with cocaine use disorder
15982483|NCT03018236|Drug|Cocaine Placebo|Flour pills looking exactly the same as the active compound, for subjects with cocaine use disorder
15982484|NCT03018223|Drug|Fludarabine|Myeloablative conditioning: 40 mg/m^2 daily for 4 days. Dose will be adjusted for estimated creatinine clearance. Reduced intensity conditioning: 30 mg/m^2 daily on days -6, -5, -4, -3 and -2. Dose will be adjusted for estimated creatinine clearance.
15982485|NCT03018223|Drug|Busulfan|Myeloablative conditioning: IV dosing targeted for a daily total area under curve (AUC) 5300 mmol*min/L for 4 days. Busulfan AUC will be pharmacokinetically targeted. An AUC 3500 mmol*min/l may be considered in patients over 60 years of age or with multiple comorbidities. Chemotherapy may start on day -6 or day -5 depending on the day of admission (-6 for Wednesday admission, -5 for Sunday admission).
15982486|NCT03018223|Drug|Cyclophosphamide|Reduced intensity conditioning: 14.5 mg/kg/day on days -6, -5. GVHD prophylaxis: 50 mg/kg ideal body weight (IBW) daily dose will be given on days +3 and +4 post-transplant as an IV infusion over 1-2 hours.
15982487|NCT03018223|Radiation|Total body irradiation (TBI)|Reduced intensity conditioning: 200 centigray (cGy) on day -1.
15982488|NCT03018223|Procedure|Peripheral Blood Hematopoietic Cell Transplantation (HCT)|On day 0, patients will receive a peripheral blood hematopoietic cell graft.
15982489|NCT03018223|Drug|Sirolimus (SIR)|GVHD prophylaxis: SIR will be administered as a 9 mg oral loading dose on day +5, followed by maintenance. SIR levels will be monitored and maintenance dosing adjusted as needed for a target trough level 8 to 14 ng/ml, per Moffitt BMT program standard practice. In the absence of acute GVHD, sirolimus taper will start on day +90 (+/- 10 days) and it is suggested to finish by day +180.
15982490|NCT03018223|Drug|Mycophenolate mofetil (MMF)|GVHD prophylaxis: MMF will start on day +5 at a dose of 15 mg/kg every 8 hours IV with the maximum daily dose not to exceed 3 gm. MMF will be changed to orally (PO) and discontinued on day +35 (without taper) in the absence of acute GVHD.
15982491|NCT03018223|Drug|Granulocyte-colony stimulating factor (G-CSF)|Growth factor support: G-CSF will be given beginning on day 5 at a dose of 5 mcg/kg/day (rounding to the nearest vial dose), until absolute granulocyte count (ANC) is > 1,000/mm^3 for three consecutive days. G-CSF may be given IV or subcutaneously.
15982493|NCT03018197|Other|Medication Education|Medication education delivered via the personal health record (MyChart) pertinent to the anticoagulation medication dabigatran. Education newsletters will be sent at 4, 6, and 10 weeks post-enrollment.
15982494|NCT03018184|Other|MRI and Muscle Dynamometer|
15982495|NCT03018171|Drug|Clonidine|Intrathecal clonidine addiction
15982496|NCT03018171|Drug|Sufentanil|Intrathecal
15982497|NCT03018158|Device|denture wear.|MR Imaging was collected with or without denture wear.
15982498|NCT03018145|Device|Wagon|
15982499|NCT03018145|Device|Standard stretcher car|
15982500|NCT03018132|Other|mental health screening, education and referral program|"I. Psychosocial assessments:
~Mental health screening for: (1) depressive symptoms with the EPDS, (2) post-traumatic stress symptoms with the IES, (3) for perceived stress with the PSS (4) for anxiety with the OASIS.
~Exercise, smoking & substance use, sleep and nutrition.
~II. If women are above cutoff values the SCID will be conducted.
~III. Education and referral information via Maternal Mental Health NOW:
~All receive a brochure entitled, Speak Up When You Are Down
~If above cutoffs, participants will also receive referral information; and will be scheduled for a SCID
~Trained study staff will review the brochure and show the woman how to use the MMHN online referral system to input their zip code and find preferred maternal mental health practitioners.
~IV. Follow up with a survey at 3 months postpartum: acceptability of screening, benefit of referral service, and outcome of this referral."
15982501|NCT03018119|Other|Survey|
15982502|NCT03018106|Drug|Ospemifene|Ospemifene is a selective estrogen receptor modulator (SERM), and it is the only SERM approved in the United States to treat moderate to severe dyspareunia associated with VVA. It is an oral medication that is taken as a 60mg tablet once daily. Food intake increases its absorption by 2 to 3-fold, and this is not impacted by the fat or calorie content of the food. It is metabolized primarily in the liver, and is excreted in feces.
15982503|NCT03018106|Drug|Vaginal conjugated estrogens|Conjugated estrogens are a mixture of several different estrogen salts derived from natural sources and blended to approximate the composition of estrogens in the urine of pregnant horses. The main components are sodium estrone sulphate and sodium equilin sulfate. Vaginal estrogen is considered the medication of choice for treating vulvovaginal atrophy (VVA).
15982504|NCT03018093|Biological|C-CAR-011|CD19-targeted chimeric antigen receptor T cells
15982505|NCT03018080|Drug|Pembrolizumab|IV (in the vein) on day 1 of a 21 day cycle
15982506|NCT03018080|Drug|Paclitaxel|IV (in the vein) on days 1 and 8 of a 21 day cycle
15982507|NCT03018067|Drug|RDX227675|
15982508|NCT03018067|Drug|Placebo|
15982509|NCT03018054|Drug|E6007|once daily administration
15982510|NCT03018054|Drug|Placebo|once daily administration
15982511|NCT03018041|Drug|Omacor|"As described in Arms."
15982512|NCT03018041|Drug|Placebo Oral Capsule|"As described in Arms."
15982513|NCT03018028|Drug|Semaglutide|Oral administration once daily
15982514|NCT03018028|Drug|Placebo|Oral administration once daily
15982515|NCT03018028|Drug|Liraglutide|Subcutaneous (s.c., under the skin) injection once daily
15982516|NCT03018015|Drug|Ibuprofen 400 mg oral powder|
15982517|NCT03018015|Drug|Ibuprofen 400 mg film-coated tablet|
15982518|NCT03018015|Drug|Ibuprofen 400 mg soft capsule|
15982519|NCT03018002|Other|iSTAR|"Each component of the iSTAR intervention targets a specific point along the HIV continuum: confidential, onsite integrated laboratory tests during baby showers targets HIV diagnosis (b) church-based Health Advisors (CHAs) trained in motivational interviewing and quality improvement skills as promotoras target linkage, engagement and adherence by providing counseling and other support to HIV-infected women and children (c) integrated network of community and clinic case management targets reduction in loss to follow-up.
~CHAs will support participants during the study period by being available to accompany them to clinic visits, review laboratory results and medications after clinic visits. They will be available to speak with them at intervals to see how they are doing either by phone or through home visits as they prefer. At each follow-up study visit, the trained CHA will review and collect data on participants' clinic visits, treatment, and laboratory results."
15982520|NCT03017989|Device|NIRF imaging|By using a fluorescence imaging device (with an adapted light source and camera), a fluorescent dye can be made visible. By injecting the fluorescent dye intravenously, the vascularization will be visible. Thereby, structures with altered vascularization are expected to 'light up' differently than the surrounding.
15982521|NCT03017963|Drug|Sodium Thiosulfate Pentahydrate|Sodium Thiosulfate Pentahydrate is administered intravenously in 250 centiliters infusion fluid in two doses: first dose with an infusion rate of 16.66 milliliter (ml) per minute (min), second dose with 8.33 ml / min
15982522|NCT03017950|Drug|CKD-330|
15982523|NCT03017950|Drug|D086|
15982524|NCT03017950|Drug|CKD-330 + D086|
15982525|NCT03017937|Device|Q-collar|capture ultrasound images at each pressure point
15982526|NCT03017924|Device|Q collar|q-collar concussion prevention device
15982527|NCT03017911|Procedure|Piccline|
15982528|NCT03017898|Procedure|Laser Coagulation|Laser coagulation of anal fistula
15982529|NCT03017872|Drug|NRTIs|"In SOC arm, choice of NRTIs determined by clinician, guided by either genotypic resistance testing or use of a protocol-specified algorithm for N(t)RTI selection.
~In D2N arm, NRTIs are predetermined."
15982530|NCT03017872|Drug|Dolutegravir|50mg tablet by mouth once daily for 96 weeks.
15982531|NCT03017872|Drug|Darunavir|800mg tablet by mouth once daily for 96 weeks.
15982532|NCT03017872|Drug|Ritonavir|100mg tablet by mouth once daily for 96 weeks.
15982533|NCT03017859|Device|High flow nasal cannula|We shall use the Airvo 2 device to administer humidified and warmed air at high flow during sleep.
15982534|NCT03017846|Drug|Cantharidin|Application of topical cantharidin
15982535|NCT03017833|Other|Laboratory Biomarker Analysis|Correlative studies
15982536|NCT03017833|Drug|Metformin|Given PO
15982537|NCT03017833|Other|Pharmacological Study|Ancillary studies
15982538|NCT03017833|Drug|Sapanisertib|Given PO
15982539|NCT03017820|Procedure|Computed Tomography|Undergo SPECT/CT
15982540|NCT03017820|Drug|Cyclophosphamide|Given IV
15982541|NCT03017820|Other|Laboratory Biomarker Analysis|Correlative studies
15982542|NCT03017820|Other|Pharmacological Study|Correlative studies
15982543|NCT03017820|Biological|Recombinant Vesicular Stomatitis Virus-expressing Human Interferon Beta and Sodium-Iodide Symporter|Given IV
15982544|NCT03017820|Drug|Ruxolitinib Phosphate|Given PO
15982545|NCT03017820|Procedure|Single Photon Emission Computed Tomography|Undergo SPECT/CT
15982546|NCT03017807|Biological|Recombinant Anti-EGFr Antibody|Low-dose level patients received cetuximab initial dose 100 mg/m2 and 4 weeks later 250 mg/m2 weekly maintenance to the disease progression or unacceptable toxicity or death or withdraw informed consent.High-dose level patients received cetuximab initial dose 400 mg/m2 and 4 weeks later loading 400 mg/m2 and 250 mg/m2 weekly maintenance to the disease progression or unacceptable toxicity or death or withdraw informed consent.
15982547|NCT03017768|Dietary Supplement|Acute tryptophan depletion|an amino-acid mixture will be administered without tryptophan (active comparator). After an incubation period of 5 hours esophageal sensitivity will be assessed by multimodal stimulation to evaluate the effect of depleted tryptophan levels on esophageal sensitivity
15982548|NCT03017768|Dietary Supplement|Placebo|an amino-acid mixture with tryptophan (placebo mixture) will be administered. After an incubation period of 5 hours esophageal sensitivity will be assessed by multimodal stimulation
15982549|NCT03017768|Device|Multimodal stimulation probe|The multimodal esophageal probe allows to perform 4 types of stimulations in the esophagus (thermal, mechanical, electrical and chemical stimulation). These 4 modalities will be evaluated to assess esophageal sensitivity.
15982550|NCT03017755|Other|Survey for Patients Treated for Scoliosis and ther Families|Your Scoliosis Journey: A Survey for Patients Treated for Scoliosis and ther Families
15982551|NCT03017729|Biological|Botulinum toxin type A|This is an observational study designed to reflect real world clinical practice in the use of abobotulinumtoxinA. AbobotulinumtoxinA injected doses, frequency of injections, number of injection sites and volume injected per site are in accordance with the current USPI and physician's clinical practice.
15982552|NCT03017716|Other|Gluten free diet|The investigators will evaluate the effect of a gluten free diet (GFD) in IBP patients, randomly assigned to receive standard therapy for IBP or standard therapy for IBP plus GFD, for a period of at least one year.
15982553|NCT03017703|Drug|Eplerenone|
15982554|NCT03017664|Other|Peptide-based enteral formula|Peptide-based, higher protein and higher calorie enteral formula
15982555|NCT03017664|Other|Retrospective review of enteral tube feeding formula|Enteral formula tube feeding will be retrospectively reviewed
15982556|NCT03017651|Dietary Supplement|OM3-supplement 1|1g of OM3-supplement 1 will be given to subjects to look at DHA/EPA blood absorption
15982557|NCT03017651|Dietary Supplement|OM3-supplement 2|1g of OM3-supplement 2 will be given to subjects to look at DHA/EPA blood absorption
15982558|NCT03017638|Other|Questionaire|Patients undergoing primary laparoscopic colectomy patients under general anesthesia with an additional Quadratus lumborum block (QLB ) will be asked to fill out a questionnaires detailing: numeric verbal analogue scores (VAS) and quality of recovery score(QoR) preoperatively, 24 hours, 48 hour and four weeks after surgery. Additional data will be collected: ASA physical status, demographics, intra- and post operative opiate(expressed as morphine equivalent in mg/kg) and non opiate consumption in order to assess the analgesic efficacy of QLB for primary laparoscopic colectomy. QLB will be performed as per standard routine regimens, in the operating room after induction of general anesthesia and prior to surgery.
15982559|NCT03017625|Other|Blood is drawn|Blood analyses
15982560|NCT03017612|Device|Raindrop Near Vision Inlay|A single-arm study to evaluate the effectiveness of a 2 mm corneal inlay (Raindrop Near Vision Inlay) for the treatment of presbyopia (age-related near vision loss). The anterior curvature of the cornea is re-shaped after implanting the Raindrop Near Vision Inlay in the non-dominant eye under a femtosecond laser flap to improve near and intermediate vision.
15982561|NCT03017599|Device|20-gauge ProCore FNB needle|"The investigators will prospectively collect data base including patients who underwent EUS-guided biopsy with the 20-gauge ProCore histology needle for the evaluation of Pancreatic solid mass.
~EUS procedures will be performed under sedation with linear echoendoscopes. Once the lesion will be penetrated, the stylet will be removed, and suction will be applied for 10 to 20 seconds by using a 10-ml syringe while moving the needle to and fro. All samples will processed at the pathology departments for histological analysis with documentation."
15982562|NCT03017586|Device|Beijing Pins Medical Co., Ltd. Deep Brain Stimulator|Deep Brain Stimulation for primary dystonia subjects
15982563|NCT03017573|Procedure|Tumor biopsies / Tumor surgery|"Tumoral tissues samples must be collected at different times points :
~at the time of surgery
~before first cycle of adjuvant treatment (if possible)
~at progression (if possible)
~OR
~before neoadjuvant therapy
~at the time of surgery
~before first cycle of adjuvant treatment (if possible)
~at progression (if possible)"
15982564|NCT03017573|Procedure|Blood withdrawal|"Blood samples must be collected at different times points :
~at the time of surgery
~after surgery
~before first cycle of adjuvant treatment or before radiotherapy
~before second cycle of adjuvant treatment or after radiotherapy
~at progression
~OR
~before neoadjuvant therapy
~during neoadjuvant therapy (post cycle 1)
~at the time of surgery
~before first cycle of adjuvant treatment or before radiotherapy
~before second cycle of adjuvant treatment or after radiotherapy
~at progression"
15982565|NCT03017560|Behavioral|Computerized cognitive treatment|Participants will engage in auditory and verbal memory exercises intended to improve verbal memory functioning. The exercises are: Elephant Memory, Words where are you?, Split words, Bird Songs, Sound check, and You've got voicemail. Participants will complete the exercises 1 hour per day, 6 days per week, for 6 weeks. The program automatically adjusts difficulty level according to individual performance. The program captures and reports all relevant data to the primary investigator, including accuracy and reaction time (speed), which will be used to measure progress.
15982566|NCT03017547|Drug|IC14|Blocks CD14 signalling which is responsible for disease pathogenesis in ARDS
15982567|NCT03017547|Other|Placebo|sterile normal saline for infusion
15982568|NCT03017534|Procedure|Spinal Manual Therapy|Supine thoracic spine sham manipulation located between the levels of T4-7; identical procedure as an active treatment intervention but without the delivery of a high velocity low amplitude thrust
15982569|NCT03017521|Drug|TAS-117|TAS-117 16mg, daily
15982570|NCT03017508|Drug|BHV-0223|35mg of sublingual riluzole before performing an anxiety provoking speech task. Participants will then be clinically assessed every hour for 3 hours.
15983845|NCT03008733|Other|Ultrasound UHF peripheral nerves|Ultrasound UHF peripheral nerves
15982571|NCT03017508|Drug|Placebo|a sublingual tablet identical to the active drug will be given before performing an anxiety provoking speech task. Participants will then be clinically assessed every hour for three hours.
15982572|NCT03017495|Drug|Midazolam|2 mg/mL oral solution
15982573|NCT03017495|Drug|ACT-541468|Hard gelatin capsules for oral use at a strength of 25 mg
15982574|NCT03017482|Device|Medtronic 670G|"This is an open labeled follow up of a clinical startup of a newly approved FDA closed loop insulin delivery system. It is essentially a prospective chart review of the clinically startup of a FDA closed loop system and has many elements of a quality improvement project with additional features of:
~Questionnaires about the utility and impact of the device
~Use of the device in children younger than the current FDA approval range"
15982575|NCT03017469|Other|ARISE|"Full day (7.5 hours) workshop consisting of a resilience-focused seminar facilitated by our Employee Assistance Provider (EAP) [Shepell], an introduction to hospital based resources including EAP and health and wellness offerings, and an introduction to self-care and self-care techniques including yoga and stretches, stress relief using the senses and mindfulness
~Half day (3.75 hours) workshop focusing on the following self-care techniques: mindfulness, yoga and stretching, and creative and reflective reading and writing
~Peer support through social media engagement (closed Facebook group) for 3 months post-intervention participation
~Five online, instructor-guided mindfulness sessions (Zoom)"
15982576|NCT03017456|Behavioral|Survivorship Care Plan|"SCP-Intervention: Patients in the SCP-Int arm will attend a one-time appointment with a trained oncology nurse while the patients in the UC arm will receive care according to the hospital standards for follow-up care. The intervention will be delivered during a regular follow-up appointment, face-to-face and will inform and educate patients on self-management and support as well as promote access to and coordination of post-treatment care. The appointment will focus on empowering the PC survivor to actively self-manage persistent treatment effects and to decrease their risk of late effects by providing effective health information, support, and self-management support. Nurses will integrate a number of active behavior change ingredients including the integration of motivational interviewing techniques which are effective in increasing healthy behaviors."
15982577|NCT03017443|Behavioral|Nutrisystem Turbo 10|Turbo10 plan provided approx. 1000 kcal/d for all subjects and included portion controlled foods/shakes for the first week (week 0). All food, except non-starchy vegetables and no-calorie beverages, was provided for the first week (week 0). Starting week 1, subjects followed the My Way plan intervention through week 16.
15982578|NCT03017443|Behavioral|Nutrisystem My Way|The Nutrisystem My Way plan provided 7 breakfasts, 6 lunches, 6 dinners, and 7 (women) or 14 (men) snacks/desserts as pre-packaged portion controlled foods every week. Subjects were instructed to prepare one lunch and one dinner on their own each week. General guidelines and recommendations were provided by Nutrisystem in order to allow subjects to self-select appropriate foods for these eating occasions that fit within the My Way plan guidelines (~50% kcal from carbohydrate, ~25% from protein, ~25% from fat). Women were assigned to 1200 calories per day and men were assigned to 1500 calories per day. Nutrisystem packaged foods accounted for approximately 60% of daily calorie target; recommended grocery food additions (which subjects purchased on their own) accounted for the balance.
15982579|NCT03017443|Behavioral|Nutrisystem DASH|The Nutrisystem DASH plan was a modification of the My Way plan designed to meet the nutrition profile of the DASH Diet, as described in NIH materials. Key nutritional targets included < 30% fat (< 7% saturated fat), < 150 mg/d of cholesterol, and < 2300 mg/d of sodium. Key dietary targets were consumption of 7-10 servings of fruit/vegetables/day, 2-3 servings of low-fat dairy/day, and 3 servings nuts/seeds/week. The Nutrisystem DASH plan included a subset of the Nutrisystem menu [7 breakfasts, 6 lunches, 6 dinners, plus snacks as portion-controlled foods every week], as well as modified guidelines for grocery additions, to achieve the nutrition targets of the DASH diet. Women consumed 1200 kcal/day and men consumed 1500 kcal/day.
15982580|NCT03017443|Behavioral|Dieting on Your Own (DIY) - DASH|The self-directed diet included publicly available information consistent with the Dietary Approaches to Stop Hypertension (DASH) diet instructing individuals to consume a reduced calorie diet to support self-directed weight loss efforts. Women were assigned to a 1200 calorie diet and men were assigned to a 1500 calorie diet. Information on the self-directed diet was provided at the beginning of the intervention (visit 2, week 0). Subjects randomized to this group did not receive additional dietary counseling throughout the study period.
15982581|NCT03017430|Drug|Pregabalin|Pregabalin 600 mg a day for six-seven days along with symptomatic therapy: Doxylamin 30 mg/day, Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine).
15982582|NCT03017430|Drug|Clonidine|Clonidine 600 micrograms a day for six-seven days along with symptomatic therapy: Doxylamin 30 mg/day, Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine)
15982583|NCT03017430|Drug|Doxylamin|
15982584|NCT03017430|Drug|Ketorolac, Loperamide, Metoclopramide, Nefazolin and Phenazepam (benzodiazepine)|
15982585|NCT03017417|Other|Exercise Intervention|Various exercise tests
15982586|NCT03017417|Other|standard of care|standard treatment
15982587|NCT03017404|Drug|Doxorubicin Hydrochloride Liposome Injection|
15982588|NCT03017404|Drug|Cyclophosphamide|
15982589|NCT03017404|Drug|docetaxel|
15982590|NCT03017391|Drug|metoclopramide|metoclopramide 10 mg tablets 3x daily orally or suppositories 10 mg 3x daily rectally, use until toxicity
15982591|NCT03017391|Drug|granisetron|granisetron patch 3.1mg/24 hours, use until toxicity
15982592|NCT03017391|Drug|Dexamethasone|dexamethasone 8 mg, last step in both algorithms
15982593|NCT03017391|Drug|Granisetron 2Mg Tablet|granisetron 2 mg loading dose
15982594|NCT03017378|Biological|TB/FLU-01L|TB / FLU-01L (intranasal application)
15982595|NCT03017378|Biological|TB/FLU-01L|TB/FLU-01L (sublingual application)
15982596|NCT03017365|Other|Stable Resistance Training|traditional machine-based resistance training
15982597|NCT03017365|Other|Unstable Resistance Training|free weight resistance training using unstable devices
15982598|NCT03017365|Other|Adductor/Abductor Resistance Training|machine-based adductor/abductor resistance training
15982599|NCT03017352|Drug|Exenatide|
15982600|NCT03017352|Drug|Placebos|
15982601|NCT03017339|Other|Functional Exercise|
15982602|NCT03017339|Radiation|Low Level Laser Therapy|
15982603|NCT03017339|Radiation|Placebo Low Level Laser Therapy|Low Level Laser Therapy with the device off
15982604|NCT03017326|Drug|Cisplatin|Arms A and B - cisplatin is used alone Arms C, D, E and F - cisplatin us used in combination
15982605|NCT03017326|Drug|Doxorubicin|Arms C, D and E used in combination
15982606|NCT03017326|Drug|Carboplatin|Arms C and D used in combination
15982607|NCT03017326|Drug|5Fluorouracil|Arm C used alone
15982608|NCT03017326|Drug|Vincristine|Arms C and D used in combination
15982609|NCT03017326|Drug|Etoposide|Arm D used in combination
15982610|NCT03017326|Drug|Irinotecan|Arm D used in combination
15982611|NCT03017326|Drug|Gemcitabine|Arm F used in combination
15982612|NCT03017326|Drug|Oxaliplatin|Arm F used in combination
15982613|NCT03017326|Drug|Sorafenib|Arm used in combination
15982614|NCT03017313|Drug|LHRH analogues|3-or 6-month formulations
15982615|NCT03017300|Device|Threshold IMT®|A device used to offer threshold load to inspiratory muscle
15982616|NCT03017300|Device|PFLEX®|A device used to offer resisive to inspiratory muscle
15982617|NCT03017287|Device|GlucoMe App|Assessment of the the GlucoMe App
15982618|NCT03017274|Other|Abdominal ultrasound examination|All subjects undergone abdominal ultrasonography at the Outpatient of Ultrasonography of the Department of Internal Medicine at the University Hospital of Palermo, Italy.
15982619|NCT03017261|Device|TSolution One®|Total knee arthroplasty with the TSolution One® System for the preparation of the femoral and tibial cuts.
15982620|NCT03017248|Drug|Ketamine|ketamine
15982621|NCT03017248|Drug|Placebos|0.9% normal saline
15982622|NCT03017248|Drug|Morphine|Morphine
15982623|NCT03017235|Drug|Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Acid Oral Solution|Supplied as two 160 mL ready-to-drink bottles, per subject, without further reconstitution, before administration.
15982624|NCT03017235|Drug|Sodium Picosulfate, Magnesium Oxide and Anhydrous Citric Powder|Supplied as two sachets per subject. Subjects will be instructed to reconstitute the medication by combining the contents of one packet with approximately five (5) ounces of cold water and stirring for two to three minutes.
15982625|NCT03017222|Drug|Ondansetron|Ondansetron also has been reported as effective prophylactic and therapeutic 5-HT3 receptor antagonist for the treatment of PONV. Ramosetron has been shown to have a very strong effect for preventing PONV in previous meta-analyses, but in recent report, its clinical significance may be questioned to request for additional study.
15982626|NCT03017222|Drug|Ramosetron|Ramosetron is a newly developed selective 5-HT3 (5 hydroxytryptamine 3) receptor antagonist with longer duration of action up to 48hours and higher receptor affinity, than its previously developed congeners, including ondansetron.
15982627|NCT03017209|Dietary Supplement|Locally-prepared bar|School children in first grade will receive their supplement 5 days a week in the morning before school starts. Younger children will receive the supplement 5 days a week in the morning at the community health center, distributed by community health workers. The teachers and community health workers will record amount of supplement consumption daily during the study, and will report the information weekly to the local research team throughout the intervention period.
15982628|NCT03017209|Dietary Supplement|USAID Corn Soy Blend Plus|School children in first grade will receive their supplement 5 days a week in the morning before school starts. Younger children will receive the supplement 5 days a week in the morning at the community health center, distributed by community health workers. The teachers and community health workers will record amount of supplement consumption daily during the study, and will report the information weekly to the local research team throughout the intervention period.
15982629|NCT03017209|Other|Placebo|School children in first grade will receive their supplement 5 days a week in the morning before school starts. Younger children will receive the supplement 5 days a week in the morning at the community health center, distributed by community health workers. The teachers and community health workers will record amount of supplement consumption daily during the study, and will report the information weekly to the local research team throughout the intervention period.
15982630|NCT03017196|Other|My Life, My Healthcare Discussion Aid|The My Life, My Healthcare instrument is a conversational tool designed to help patients and clinicians discuss capacity in clinical conversations of primary care.
15982631|NCT03017183|Procedure|EBUS-TBNA|Endobronchial ultrasound guided transbronchial needle aspiration
15982632|NCT03017183|Procedure|Endobronchial forceps biopsy|Conventional endobronchial forceps biopsy
15982633|NCT03017170|Drug|Dried Cranberry|"Dried cranberry powder is not an extract of cranberries, but a full spectrum ingredient. It is comprised of a proprietary ratio of dried cranberry fruit, cranberry pomace, and cranberry seeds, each of which is a recognized food and/or dietary ingredient. One 500 mg capsule of dried cranberry powder consists of approximately 25 grams of cranberry fruit."
15982634|NCT03017170|Drug|Placebo Oral Capsule|Colored Maltodextrin: Proprietary mixture of: maltodextrin and food grade colors
15982635|NCT03017157|Other|Echo-cardiogram|Patients will undergo echo-cardiogram to determine improvement in their heart function and this will be compared to thyroid function
15982636|NCT03017157|Other|Blood test|Blood test to determine thyroid function
15982637|NCT03017144|Other|Pit crew model education|A pit crew model for resuscitation is educated to all resuscitation team members.
15982638|NCT03017131|Biological|Aldesleukin|Given SC
15982639|NCT03017131|Drug|Cyclophosphamide|Given IV
15982640|NCT03017131|Drug|Decitabine|Given IV
15982641|NCT03017131|Biological|Genetically Engineered NY-ESO-1-specific T Lymphocytes|Given IV and IP
15982642|NCT03017131|Other|Laboratory Biomarker Analysis|Correlative studies
15982643|NCT03017118|Dietary Supplement|Turmeric|Subjects will receive turmeric (100 mg pastille) 3 times per day for 6 weeks.
15982644|NCT03017118|Other|Placebo|Subjects in the control group will receive a placebo 3 times per day for 6 weeks.
15982645|NCT03017105|Other|Cross-education of strength-training|Strength-training exercises using isometric contractions and resistance bands to be performed with the uninjured arm
15982646|NCT03017105|Other|Usual rehabilitation|Exercises to improve range of movement, strength and movement control (as standard for non-operatively managed proximal humerus fractures)
15982647|NCT03017092|Behavioral|Tablet-guided tobacco intervention|This intervention, as guided by a tablet computer, is a brief (20 minute) counseling intervention designed to increase motivation to quit smoking and to increase knowledge of methods of quitting.
15982648|NCT03017079|Dietary Supplement|semi-solid agent|after infusion of semi-solid agent, Intermittent enteral feeding is applied less than 60 mins
15982649|NCT03017079|Other|standard enteral feeding|Intermittent enteral feeding is applied less than 60 mins
15982650|NCT03017066|Device|Ultrasound|Ultrasound assessment of gastric volume is performed three times; before ingestion of infant formula or carbohydrate drink; 1 hour prior to the surgery; and before induction of general anesthesia.
15982651|NCT03017066|Other|General anesthesia|Scheduled operation under general anesthesia
15982652|NCT03017053|Radiation|Radiotherapy|Radiotherapy after primary surgery in the treatment of early oral cancer based on adverse pathological factor
15982653|NCT03017053|Procedure|Elective neck dissection|Elective neck dissection after primary surgery in the treatment of early oral cancer based on adverse pathological factor
15982654|NCT03017040|Device|CT scan|A CT scan of the wrist
15982655|NCT03017040|Device|Fluoroscopy Scan|A fluoroscopy scan of the wrist.
15982656|NCT03017027|Behavioral|Therapy dog visitation (TDV)|The TDV intervention consists of a one-time 10 minute TDV with the dog handler and his/her dog interacting with the patient. The therapy dog visitation program is a currently established program and each therapy dog meets obedience, temperament, and health standards required by the organization and are deemed appropriate to therapy dog visitation. For hygienic reasons, dogs are bathed before visitation and the patient is required to wash hands before and after the visit. The TDV will be casual and not restrict the handler with conversing, which is standard practice in TDV. The therapy dog will be leashed and controlled by the dog handler. If the participant wants the dog to be placed on the bed, a clean sheet will be placed on the bed in between the dog and patient. The TDV will be casual and not restrict the handler with conversing, which is standard practice in TDV. Tactile and visual contact with the dog will be promoted.
15982657|NCT03017027|Behavioral|non-TDV control|Participants randomized to the control condition will receive a new plush stuffed animal for the same 10-min timeframe without any structured activities. At the end of the session, a stuffed animal will be offered to the participant to keep.
15982658|NCT03017001|Dietary Supplement|CHO (carbohydrate)|Patients in this group received a preoperative fast for solids for 6h and a drink containing water plus 12.5% maltodextrine (carbohydrate) 2h before anesthesia
15982659|NCT03017001|Drug|intravenous w-3 PUFA|Patients in this groups received during the operation (intraoperative) a dose of intravenous w3-PUFA
15982660|NCT03017001|Other|CHO (carbohydrate) plus intravenous w3-PUFA|Patients in this group received a preoperative fast for solids for 6h and a drink containing water plus 12.5% maltodextrine (carbohydrate) 2h before anesthesia, plus an intravenous dose of w3-PUFA intraoperatively
15982661|NCT03016988|Drug|Bortezomib|Bortezomib(V) 1.3mg/m2, subcutaneously,day 1,4,8,11;
15982662|NCT03016988|Drug|Fludarabine|Fludarabine(F) 25mg/m2, intravenously day 1-3;
15982663|NCT03016988|Drug|Cytarabine|Cytarabine(A) 500mg/m2 for 3 days(day1-3)
15982664|NCT03016975|Device|Edwards Cardioband System|Transcatheter mitral valve repair with the Edwards Cardioband System
15982665|NCT03016962|Device|cap-assisted colonoscopy|cap-assisted colonoscopy
15982666|NCT03016962|Device|Standard colonoscopy|Standard colonoscopy
15982667|NCT03016949|Biological|IPV|Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
15982668|NCT03016949|Biological|f-IPV|Comparison of different vaccination schedules with 2 different vaccines (IPV and f-IPV) and 2 different types of administration (IM and ID)
15982669|NCT03016923|Device|FES Therapy|FES therapy will be administered over the course of 1 hour sessions that will be take place 3 times per week over 16 weeks, for a total of 48 sessions.
15982670|NCT03016897|Other|Respirometer, Handgrip Meter, Skulpt Chisel, ActigraphyMeter|Respirometer, Handgrip Meter, Skulpt Chisel, ActigraphyMeter
15982671|NCT03016884|Biological|Zostavax vaccine|After the screening, the eligible patients who provided the informed consent, will be administered the zoster vaccine.
15982672|NCT03016871|Drug|Carboplatin|Given IV
15982673|NCT03016871|Drug|Etoposide|Given IV
15982674|NCT03016871|Drug|Ifosfamide|Given IV
15982675|NCT03016871|Other|Laboratory Biomarker Analysis|Correlative studies
15982676|NCT03016871|Biological|Nivolumab|Given IV
15982677|NCT03016858|Procedure|Thoracoscopic Bullectomy Surgery|undergoing the Thoracoscopic Bullectomy Surgery
15982678|NCT03016832|Drug|Placebo drug that simulates Irbesartan tablets|Placebo drug that simulates Irbesartan tablets 150mg /qd, oral dosing
15982679|NCT03016832|Drug|irbesartan tablets|irbesartan tablets 150mg /qd, oral dosing
15982680|NCT03016832|Drug|Placebo drug that simulates HuangKui capsule|Placebo drug that simulates HuangKui capsule 2.5g/tid, oral dosing
15982681|NCT03016832|Drug|HuangKui Capsule|HuangKui Capsule 2.5g/tid, oral dosing.
15982682|NCT03016819|Drug|AL3818|Anlotinib (AL3818) 12 mg orally administered once daily in 21-day cycles (14 days on treatment, 7 days off treatment)
15982683|NCT03016819|Drug|Dacarbazine|Dacarbazine 1000 mg/m2 as a 20-120 minute IV infusion on Day 1 of each 21-day treatment cycle
15982684|NCT03016819|Drug|AL3818 or placebo|AL3818 or placebo 12 mg orally administered once daily in 21-day cycles (14 days on treatment, 7 days off treatment)
15982685|NCT03016806|Radiation|Total Body Irradiation 1200 cGy|Total Body Irradiation 1200 cGy in 8 fractions
15982686|NCT03016806|Radiation|Total Body Irradiation 200 cGy|Total Body Irradiation 200 cGy in one fraction
15982687|NCT03016806|Drug|Cyclophosphamide|50 mg/kg or 60 mg/kg
15982688|NCT03016806|Drug|Mesna|50 mg/kg or 60 mg/kg plus 10% loading dose
15982689|NCT03016806|Procedure|Cord Blood Infusion|Intravenous infusion of cord blood stem cells
15982690|NCT03016806|Drug|Busulfan|0.8 mg/kg x 16 doses
15982691|NCT03016806|Drug|Fludarabine|30 mg/m2/day x 5 or 40 mg/m2/day x 5
15982692|NCT03016806|Drug|Melphalan|140 mg/m2
15982693|NCT03016793|Drug|Puerarin|purabone (puerarin) is a bone graft used for surgical repair of bony defects.
15982694|NCT03016793|Drug|β- tricalcium phosphate|β- tricalcium phosphate is a bone graft used for surgical repair of bony defects
15982695|NCT03016793|Drug|β- tricalcium phosphate alone|β- tricalcium phosphate is a bone graft used for surgical repair of bony defects
15982836|NCT03015818|Other|18F-Fluoride PET-CT ; CT calcium scoring ; 18F-FDG PET-CT|18F-Fluoride PET-CT CT calcium scoring 18F-FDG PET-CT
15982696|NCT03016780|Other|Fecal Microbiota Transplantation|Fecal microbiota transplantation and the traditional treatments for ulcerative colitis in part 1.
15982697|NCT03016780|Other|Normal Saline|Normal saline and the traditional treatments for ulcerative colitisin in part 2.
15982698|NCT03016767|Procedure|Manual oral stimulation protocol|
15982699|NCT03016754|Device|Wearable Cardioverter Defibrillator|LifeVest Wearable Cardioverter Defibrillator
15982700|NCT03016741|Biological|GnRH agonist/antagonist|Given GnRH agonist/antagonist therapy
15982701|NCT03016741|Drug|Prednisone|Given by mouth
15982702|NCT03016741|Drug|Abiraterone Acetate|Given by mouth
15982703|NCT03016741|Drug|Enzalutamide|Given by mouth
15982704|NCT03016728|Behavioral|Physical Activity|Participants will receive a 12-week home-based physical activity program that has been individualized using their baseline assessment results. The program will be comprised of aerobic training (2 days/week) and resistance training (2 days/week). The aerobic training will be performed unsupervised. The resistance training will be performed under the supervision of a study team member (who will visit participants homes) for the first 6 weeks to ensure proper form and safety.
15982705|NCT03016715|Drug|Sirolimus 2%|
15982706|NCT03016715|Drug|Vehicle|
15982707|NCT03016702|Other|Cognitive stress tests during functional MRI|Subjects will undergo progressively more complex cognitive stress tests that assess memory and executive function while undergoing fMRI.
15982708|NCT03016702|Other|Cognitive stress tests during gait task|Subjects will undergo progressively more complex cognitive stress tests that assess memory and executive function both in sitting and while ambulating on a force sensor mat.
15982709|NCT03016676|Other|Spinal Manipulation|High velocity low amplitude thrust (HVLA) to the lumbar region of the spine between L1 and L5 vertebrae. The exact level thrust will be at the discretion of the treating practitioner determined by the level with the greatest perceivable motion restriction. The HVLA thrust will be performed with the patient side lying in a neutral.They take part in 12 treatment visits, 10 to 20 minutes sessions of SM over 2 weeks. Light soft tissue techniques (i.e., active and passive muscle stretching, and ischemic compression of tender points) may be used as needed to facilitate the manual therapy.
15982710|NCT03016676|Other|Exercise therapy|Self education, supervised exercise visits, and home exercise. The overall objectives are to help patient's mange their LBP and prevent future LBP recurrences. Total number of visits 12.Each visit starts with 10 minutes of self-care education to help patients establish and monitor goals aligned with the exercise program and enhance their understanding of LBP. Participants will be taught the importance of movement and activity, pain management techniques, and methods for developing spinal posture awareness during activities of daily living (e.g., lifting, pushing, pulling, sitting, getting out of bed, and using a backpack).
15982711|NCT03016663|Procedure|Technique of Breast Lipofilling|"Identification of the donor site Procedure carried out in single sessions under GA. Abdominal site identified and outlined with a skin marker.
~Fat Harvesting Berlin autologous lipotransplantation technique used according to the BEAULI protocol described by Ueberreiter et al.
~Infiltration solution -Klein'solution contains 1 cc of epinephrine (1:500,000) diluted in 500 cc of 0.001% lactate ringer solution (LRS).
~Fat Processing After aspiration of nonviable components of the aspirate, fat graft washed using Lactate Ringer Solution for three times. The fat processing and washing were performed by the same assistant for all patients.
~Fat Transfer (Injection) Fat is injected in small amounts as the needle is gradually withdrawn. Periglandular planes and intrapectoral planes are used. Intraparenchymal injection avoided."
15982712|NCT03016650|Drug|Acetaminophen|Patients receive 100 mL of physiologic saline with 1 g IV paracetamol 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after PCNL
15982713|NCT03016650|Drug|Ibuprofen|Patients receive 100 mL of physiologic saline with 800 mg IV ibuprofen 30 minutes before the end of the operation and postoperatively 6, 12 and 18 hours after PCNL
15982714|NCT03016637|Device|SharkCore (TM) FNB Exchange System|
15982715|NCT03016624|Device|OCT guided PCI|oct guided
15982716|NCT03016624|Device|Angiography guided PCI|angio guided
15982717|NCT03016611|Drug|Chewing Ticagrelor LD|180 mg Chewing Ticagrelor
15982718|NCT03016611|Drug|Chewing Prasugrel LD|60 mg Chewing Prasugrel
15982719|NCT03016598|Drug|Intranasal oxytocin|Each Veteran with a stimulant use disorder, receiving MMT for OUD will receive a oxytocin nasal spray 40 International Units (IU) to be self administered twice daily over 6 weeks while in the MMT program. The veteran will come in for a total of 7 weekly visits. At baseline and during the last visit the veteran will complete at Trier Social Stress Test (TSST), and psychophysiological and biomarkers of stress will be collected. At every weekly visit a urine sample and self-reported drug use will be collected and therapy attendance will be recorded.
15982720|NCT03016598|Drug|Intranasal placebo|Each Veteran with a stimulant use disorder, receiving MMT for OUD will receive a placebo nasal spray 40IU to be self administered twice daily over 6 weeks while in the MMT program. The veteran will come in for a total of 7 weekly visits. At baseline and during the last visit the veteran will complete at Trier Social Stress Test (TSST), and psychophysiological and biomarkers of stress will be collected. At every weekly visit a urine sample and self-reported drug use will be collected and therapy attendance will be recorded.
15982721|NCT03016585|Other|Tai Chi Training|Participants practiced, under supervised instruction, 10 forms from the classic Yang style of Tai Chi 3 times per wk for 12 weeks.The Tai Chi sessions lasted approximately 55 minutes and included a 10-minute warm up, 40 minutes of practice and exercise finalizing with a 5-minute cooldown period.
15982722|NCT03016572|Behavioral|Standard of Care|Follow-Up Calls, Questionnaires
15982723|NCT03016572|Behavioral|Crisis Intervention|Frontline Services will be administering follow up phone calls for participants of the study, recently discharged from the emergency room.
15982724|NCT03016572|Behavioral|Wraparound Services|Tapestry will be assigning case management services for participants randomized into the third arm of the study.
15982725|NCT03016559|Other|releasing muscle|At baseline, hip and knee angles were measured. The quadratus lumborum muscle was released. After that, the hip and knee angles were re-measured.
15982755|NCT03016338|Drug|TSR-042|500 mg once intravenously on day 1 of cycle (From cycle 1-4 followed by 1000 mg intravenously every 6 weeks for maximum of 2 yrs)
15982756|NCT03016325|Drug|HNO Donor|Infusion
15982757|NCT03016325|Drug|Placebo|Infusion
15982968|NCT03014882|Drug|L-Carnitine and N-acetyl cysteine|
15982726|NCT03016546|Behavioral|BEST-maCARE|Features of the integrated BEST-maCARE intervention approach include: Integration of depression screening and linkages to HIV and mental health treatment in the context of perinatal care; A trained, clinic-based nurse (study nurse) plays a mediating role between the health system and its beneficiaries; scheduling of appointments; and, accompanying the patient as needed to initial appointments if desired, and, follow up. Low cost, mobile phone technology is used for frequent one:to:one patient contact with a health care provider (the study nurse) to facilitate continuity of care (for mental health, HIV and pregnancy across the continuum of care from prenatal through postpartum) and promotion of self-care (adherence) and retention in care with a theory-guided, empirically-supported, standardized counseling intervention that is delivered proactively by the study nurse over 18 weeks.
15982727|NCT03016546|Behavioral|Attention Control Condition|The control group will receive an intervention that is time and attention equivalent to the experimental condition. The attention effect that is likely with provision of a mobile phone in the experimental condition will be controlled by providing mobile phone to the control group participants and, they will receive time matched calls from the study nurse with content of the calls focused on infant and maternal nutritional health education per Indian National Guidelines. The phone will be used for delivery of the interventions and may also be used by study staff for purposes of establishing contact or to collect survey interview data if necessary. Time, date, and content of all phone contacts will be documented by the nurse and evaluated in the analysis.
15982728|NCT03016533|Drug|Dolutegravir film-coated tablets|Dolutegravir film-coated tablets will be provided as 10 mg, 25 mg and 50 mg tablets. It will be administered at the dose of approximately 1 mg/kilogram (kg) with maximum dose of 50 mg to participants as per their age and weight band.
15982729|NCT03016533|Drug|Dolutegravir film-coated dispersible tablets|Dolutegravir film-coated dispersible tablets will be provided as 5 mg dispersible tablets. It will be administered at the appropriate dose as determined by results of the parent protocol to participants as per their age and weight band.
15982730|NCT03016533|Drug|ABC/DTG/3TC immediate release tablets|ABC/DTG/3TC immediate release tablets will be provided as biconvex, oval tablets containing 600 mg ABC, 50 mg DTG and 300 mg 3TC.
15982731|NCT03016533|Drug|ABC/DTG/3TC film-coated dispersible tablets|ABC/DTG/3TC dispersible tablets will be provided as biconvex, oval, film-coated tablets containing 60 mg ABC, 5 mg DTG and 30 mg 3TC.
15982732|NCT03016520|Drug|DWJ1392|
15982733|NCT03016520|Drug|DWC20164|
15982734|NCT03016494|Drug|Co-administration of DWC20155 and DWC20156|
15982735|NCT03016494|Drug|DWJ1386 Tab.|
15982736|NCT03016481|Behavioral|Active Comparator: the Community Health Worker -Personalized Support for Progress|Subjects will meet with their CHW to prioritize their needs detected by the Promote psychosocial screening and identify their preferences for intervention using a secure, online card sorting tool called Optimal Sort. The subject will explain her/his rationale for each decision to the CHW, allowing them both to begin to identify goals. The prioritization survey results provide subjects a personalized package of services that map onto the four main intervention options: legal help, problem solving therapy, medical consultation, or social services.
15982737|NCT03016481|Behavioral|Care as Usual- Social Worker|Based on their assessment and the subjects' needs, brief onsite interventions are provided and consist of empowerment focused advocacy, IPV education, community referrals, and safety planning. Participants determine follow-up. This will be a short-term interaction as routinely practiced across hospital settings.
15982738|NCT03016468|Drug|Parenteral Remodulin (treprostinil) injection|Remodulin will be provided in vial strengths of 1, 2.5, 5, and 10 mg/mL. Subjects will be admitted to the hospital and IV Remodulin will be initiated within 12 hours after the last dose of selexipag. Subjects will remain under observation in the inpatient setting for at least the first 72 hours of Remodulin administration. Subjects will be transitioned to an equivalent dose of SC Remodulin at discharge.
15982739|NCT03016468|Drug|Oral Treprostinil|Oral treprostinil will be provided as 0.125-, 0.25-, 1-, or 2.5-mg extended-release tablets. Oral treprostinil will be dosed three times daily with food.
15982740|NCT03016455|Other|Presence of DSA w/ cAMR|
15982741|NCT03016455|Other|Presence of DSA w/o cAMR|
15982742|NCT03016455|Other|No DSA No cAMR|
15982743|NCT03016442|Device|Cook Double Balloon Catheter|A double- balloon catheter (Cook Cervical Ripener Balloon,Cook OB/GYN,Spencer IN) is inserted into cervical canal under direct visualisation during a sterile speculum examination.İt is placed for 12 hours
15982744|NCT03016442|Drug|Dinoprostone|10 mg of dinoprostone in a hydrogel insert is placed high in the vaginal fornix. İt is placed for 12 hours.It is a controlled release formulation which has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg/hr.
15982745|NCT03016403|Behavioral|Stepped-Care Intervention|The intervention delivered evidence-based CBT and stress management across eight counseling sessions.
15982746|NCT03016403|Behavioral|Enhanced Usual Care|Consists of a list of standard mental health resources offered at the participating hospital, local community, or national non-profit organizations.
15982747|NCT03016377|Biological|iC9-CAR19 cells|Three dose levels are being evaluated: dose level -1 (1 x 10^5), dose level 1 (5 x 10^5), and dose level 2 ( 1x 10^6)
15982748|NCT03016377|Drug|Rimiducid|Subjects who develop grade 4 CRS or grade 2/3 CRS that is unresponsive to standard of care interventions will be given Rimiducid at .4 mg/kg.
15982749|NCT03016377|Drug|Cyclophosphamide|900 mg/m^2 IV over 1 hour on day 4 of lymphodepleting chemotherapy.
15982750|NCT03016377|Drug|Fludarabine|25 mg/m^2/day IV over 30 minutes administered for 3 consecutive days.
15982751|NCT03016364|Device|APP software|A software used to by physicians to adjust the dose of Oxycodone Hydrochloride Prolonged-release Tablets for advanced patient's with cancer pain
15982752|NCT03016351|Other|Aerobic Training|After the subject meets all inclusion and exclusion criteria, the subject will be randomized equally to either the ResistanceTraining group (RT) or Aerobic Training group (AT) for weeks 9-16 of the intervention. The participants will be supervised by physical therapists and/or exercise physiologists. Sessions will occur 3 days a week and will be 45 minutes in duration.
15982753|NCT03016351|Other|Resistance Training|After the subject meets all inclusion and exclusion criteria, the subject will be randomized equally to either the ResistanceTraining group (RT) or Aerobic Training group (AT) for weeks 9-16 of the intervention. The participants will be supervised by physical therapists and/or exercise physiologists. Sessions will occur 3 days a week and will be 45 minutes in duration.
15982760|NCT03016299|Procedure|microfracture techniques|Drill will be performed in 3 contiguous areas. First Area by Nailing, Second by KW drilling and 3rd area drilled by regular drill obtaining a triangle with the three drilled epicenters.
15982761|NCT03016286|Other|vibration|Whole body vibration at 25Hz frequency
15982762|NCT03016273|Procedure|creation of bladder flap|Creation of the bladder flap, i.e., dissecting the urinary bladder from the lower segment of the uterus is a standard part of cesarean section (CS).
15982763|NCT03016260|Biological|Infliximab|Anti-TNF alpha originator
15982764|NCT03016260|Biological|Adalimumab|Anti-TNF alpha originator
15982765|NCT03016260|Biological|Etanercept|Anti-TNF alpha originator
15982766|NCT03016260|Biological|Golimumab|Anti-TNF alpha originator
15982767|NCT03016260|Biological|Certolizumab Pegol|Anti-TNF alpha originator
15982768|NCT03016260|Biological|Infliximab biosimilar|Anti-TNF alpha Infliximab biosimilars
15982769|NCT03016260|Biological|Etanercept biosimilar|Anti-TNF alpha Etanercept biosimilar
15982770|NCT03016260|Biological|Infliximab biosimilar|Anti-TNF alpha Infliximab biosimilar
15982771|NCT03016247|Behavioral|TRUST Intervention|The TRUST intervention will be guided by Rotenberg's Framework of Interpersonal Trust 3. The TRUST group will meet with an interventionist trained in weight self-management for eight 90-minute weekly sessions. Each session will include adolescent/parent trust-building exercises (honesty, reliability, emotional connection), didactic content, experiential skills developing (nutrition label reading), behavior-change goal-setting, and problem-solving.
15982772|NCT03016247|Behavioral|Enhanced Usual Care|Single meeting with a Nutritionist for physical activity and eating counseling.
15982773|NCT03016234|Drug|Desflurane|On arrival in the operating room, initial intraocular pressure is measured after administration of alcaine 0.5% eye drop and routine monitoring and bispectral index(BIS) are applied. Anesthesia is induced with pentothal sodium inj (thiopental sodium 0.53g) 5-6mg/kg and esmeron inj (rocuronium bromide 50mg/5ml) 1mg/kg. Then endotracheal intubation is performed, anesthesia is maintained with 50% oxygen-air-4~7% desflurane inhalation and intravenous remifentanil continous infusion (effect site concentration 3-6ng/mL) during operation. Desflurane concentration is titrated to maintain BIS values within a target range 40-60 during operation. Mean arterial blood pressure, peak airway pressure, end tidal carbon dioxide, and IOP on both eyes are measured at defined intervals.
15982774|NCT03016234|Drug|Propofol|On arrival in the operating room, initial intraocular pressure is measured after administration of alcaine 0.5% eye drop and routine monitoring and bispectral index(BIS) are applied. Anesthesia is induced with fresofol MCT 1% inj (1% propofol) 1.5-2.5mg/kg and esmeron inj (rocuronium bromide 50mg/5ml) 1mg/kg. Then endotracheal intubation is performed, anesthesia is maintained with intravenous fresofol MCT 2% inj (2% propofol, effect site concentration 2.5-5μg/mL) and remifentanil (effect site concentration 3-6ng/mL) continous infusion. Effect site concentration of propofol is titrated to maintain BIS values within a target range 40-60 during operation. Mean arterial blood pressure, peak airway pressure, end tidal carbon dioxide, and IOP on both eyes are measured at defined intervals.
15982775|NCT03016221|Other|Axanova hot gel|Axanova hot gel is a topical product with a warming effect. It contains menthol, pine needle oil, wintergreen oil, rosemary oil, eucalyptus oil, incense oil.
15982776|NCT03016221|Other|Axanova activ gel|Axanova activ gel is a topical product with a revulsive effect. It contains menthol, pine needle oil, orange oil, lemon oil, wintergreen oil, glycosaminoglycans.
15982777|NCT03016221|Other|Perskindol Dolo Gel|Perskindol Dolo Gel is a topical product with a warming effect. It contains wintergreen oil, pine needle oil, aromatics, excipients.
15982778|NCT03016221|Other|Perskindol Classic Gel|Perskindol Classic Gel is a topical product with a revulsive effect. It contains menthol, wintergreen oil, pine needle oil, lemon oil, orange peel oil, lemon bergamot oil, rosemary oil, lavender oil, excipients.
15982779|NCT03016221|Other|Perskindol Cool Kühl-Gel|Perskindol Cool Kühl-Gel is a topical product with a cooling effect. It contains levomenthol, color E131, aromatics, excipients.
15982780|NCT03016221|Other|Dolor-X Hot Gel|Dolor-X Hot Gel is a topical product with a warming effect. It contains isopropyl alcohol, water, menthol, hyprolose, camphor, trometamol, paprika, wintergreen oil, excipients.
15982781|NCT03016221|Other|Dolor-X Classic Gel|Dolor-X Classic Gel is a revulsive product. It contains water, isopropyl alcohol, menthol, spruce, hyprolose, trometamol, wintergreen oil, excipients.
15982782|NCT03016221|Other|Dolor-X Cool Gel|Dolor-X Cool Gel is a cooling product. It contains water, isopropyl alcohol, menthol, trometamol, color E131, excipients.
15982783|NCT03016208|Drug|Misoprostol vaginal insert|
15982784|NCT03016182|Procedure|Remote Ischemic Preconditioning|RIPC will be induced during anesthesia by 3 cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure 200mmHg
15982785|NCT03016182|Procedure|Control|Control group witnout remote ischemic preconditioning
15982786|NCT03016169|Device|Trifecta GT (Glide Technology) Valve|Surgical aortic valve replacement with Trifecta GT Valve.
15982787|NCT03016156|Other|CRADLE|"A smartphone software application designed to detect leukocoria using a sophisticated photoluminic analysis.
~The investigator or designee will perform tests with CRADLE in separate patient cohorts with known diagnosis of retinoblastoma, congenital glaucoma, or cataracts."
15982788|NCT03016156|Other|Red reflex testing|Traditional red reflex testing for leukocoria using a direct ophthalmoscope on routine eye examination. Red reflex testing via direct ophthalmoscope will be performed before dilation, using the ophthalmoscope held close to the examiner's eye, focused on the pupil, viewed at 12 to 18 inches from the patient's eyes, with the room lights dimmed, in accordance with the American Academy of Pediatrics guidelines.
15982789|NCT03016143|Biological|Allantoic Split Inactivated Seasonal flu Vaccine|Allantoic split inactivated seasonal influenza vaccine has been prepared on eggs and is made from inactivated parts of the following influenza virus strains: NIBRG-121xp (A/California/7/2009 (H1N1)v and А/PR/8/34 (H1N1)), NYMC X-217 (A/ Victoria/361/2011(H3N2) and А/PR/8/34 (H1N1)), NYMC BX-49 (B/Texas/06/2011 (Yamagata lineage) - like High Yield Reassortant (1:1:6) With B/Lee/40 NP, B/Panama/45/90 NS genes).
15982790|NCT03016143|Biological|VAXIGRIP|Vaxigrip - Seasonal Influenza, split virion, inactivated vaccine. Sanofi Pasteur Serial Number N3E681V
15982791|NCT03016130|Other|Diet|Diet Intervention: Subjects will undergo stratified randomization to account for the heterogeneous population, to receive one of the two diets: liberalized hospital diet (Diet A) or a neutropenic diet (Diet B).
15982792|NCT03016117|Procedure|Pecs II block and parasternal block|The Pecs II block will be performed under ultrasound guidance, at fourth rib level, on the axillary line, into the fascial plane between pectoralis minor muscle and serratus muscle. The parasternal block will be performed under ultrasound guidance, at the second and fourth intercostal space, between the pectoralis major muscle and the intercostal muscles, near to the external intercostal membrane.
15982793|NCT03016104|Device|Magpro X100 + Option|In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of MST in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks.
15982794|NCT03016104|Device|ThymatronSystem Ⅳ Electroconvulsive System|In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of modified ECT in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks
15982795|NCT03016104|Other|treatment as usual (TAU)|Participants will engage in their inpatient treatment program as-usual.
15982796|NCT03016091|Drug|Pembrolizumab|anti PD-L1
15982797|NCT03016078|Device|Mepilex Border Post-Op Ag|To investigate if there was any skin damage under the dressing from operation day to last visit.
15982798|NCT03016065|Dietary Supplement|Pea Fiber|Baked goods (2 snacks) with fiber-fortified with 5 g/snack of ground pea hulls
15982799|NCT03016065|Dietary Supplement|Control|Baked goods (2 snacks) without added fiber
15982800|NCT03016052|Behavioral|ABMT|Participants will be trained with a dot-probe task including angry-neutral faces. The task will be adapted for the oddball paradigm, such that in 80% of trials the probe will appear in place of the neutral face, and in 20% of trials in place of the angry face.
15982801|NCT03016039|Dietary Supplement|Curcumin supplementation|use of curcumin supplementation as an additive treatment to the conventional treatment
15982802|NCT03016026|Procedure|ERAS|Undergo an ERAS program
15982803|NCT03016013|Biological|Placebo plus MTX|All patients had a foundation MTX therapy.The researchers evaluated the efficacy of the patient in 12 week.Study investigator evaluate the patients of curative effect.The researchers evaluated the efficacy of the patient in 12 week.Evaluation of efficacy in patients if not get the ACR20 response, adjust the treatment plan given the test drug.Test group continue to the test drug,placebo group switch to the test drug.
15982804|NCT03016013|Biological|RC18 160 mg plus MTX|
15982805|NCT03016000|Drug|Thalidomide|Thalidomide 50mg daily by mouth( increase 25mg after 2 weeks if tolerated Until 200mg/day) until disease progression or intolerance due to AEs.The dose could be reduced if patient experienced grade 2 or higher AEs. Does reductions for AEs were recommended (200 mg daily to 100 mg daily, 100 mg daily to 50 mg daily).In patients intolerant of 50mg/ day, thalidomide discontinuation was allowed.
15982806|NCT03016000|Other|Observation|Just observation
15982807|NCT03015987|Other|diode laser activated irrigation|diode laser became the most common and affordable type of laser used in endodontics for many uses , its disinfection effect is an important issue which not discussed in clinical trial before , So this study is assigned to study that
15982808|NCT03015974|Drug|Corticosteroid|
15982809|NCT03015974|Drug|Cyclophosphamide|
15982810|NCT03015974|Drug|Mycophenolate mofetil|
15982811|NCT03015974|Drug|Dipyridamole|
15982812|NCT03015974|Drug|ACE Inhibitor or Angiotensin receptor antagonist|
15982813|NCT03015961|Drug|EXPAREL and bupivacaine HCl|"Drug: EXPAREL EXPAREL and bupivacaine HCl
~Other Name: bupivacaine liposome injectable suspension Drug: Bupivacaine Single dose of bupivacaine HCl 0.5%
~Other Name: bupivacaine HCl"
15982814|NCT03015961|Drug|Bupivacaine HCl|"Drug: Bupivacaine Single dose of bupivacaine HCl 0.5%
~Other Name: bupivacaine HCl"
15982815|NCT03015948|Drug|SHR4640|a single dose of SHR4640 (n=8) for each dose cohort
15982816|NCT03015948|Drug|Placebo|a single dose of placebo (n=2) for each dose cohort .
15982817|NCT03015935|Procedure|visual-assisted entry|First trocar entry will be performed with visual-assisted trocar
15982818|NCT03015935|Procedure|Veress entry|First trocar entry will be performed with Veress
15982819|NCT03015922|Drug|Lenalidomide or Pomalidomide|Patients will received either lenalidomide or pomalidomide, depending on which drug they were receiving prior to the trial (they will receive the same as before).
15982820|NCT03015922|Biological|REOLYSIN|Patients will receive Reolysin alongside either lenalidomide or pomalidomide
15982821|NCT03015909|Drug|Somatropin|
15982822|NCT03015896|Other|Laboratory Biomarker Analysis|Correlative studies
15982823|NCT03015896|Drug|Lenalidomide|Given PO
15982824|NCT03015896|Biological|Nivolumab|Given IV
15982825|NCT03015883|Radiation|Diffusing Alpha Radiation Emitters Therapy (DaRT)|An intratumoral insertion of a seed(s), loaded with Radium-224, securely fixed in the seeds. The seeds release by recoil into the tumor short-lived alpha-emitting atoms.
15982826|NCT03015870|Behavioral|Vocal exercise with real-time feedback|The feedback intervention will use iPads pre-installed with a PDF of vocal exercises for the full duration of the study and with an app which will provide tailored feedback regarding pitch, loudness, and duration of phonation during practice sessions.
15982827|NCT03015870|Behavioral|Vocal exercise with recording|The recording intervention will use an iPad pre-installed with the PDF of vocal exercises for the full duration of the study, but no feedback app.Participants audio record self while performing vocal exercises
15982828|NCT03015857|Drug|phenylephrine|- phenylephrine; a vasopressor drug given to prevent post spinal hypotension
15982829|NCT03015857|Drug|Norepinephrine|- norepinephrine; a vasopressor drug given to prevent post spinal hypotension
15982830|NCT03015857|Drug|Bupivacaine|intrathecal bupivacaine 10 mg will be given in both groups
15982831|NCT03015857|Drug|Fentanyl|intrathecal fentanyl 20 mcg will be given in both groups
15982832|NCT03015857|Drug|Placebo (normal saline)|
15982833|NCT03015844|Drug|131-I-meta-iodobenzylguanidine|
15982834|NCT03015831|Drug|Colchicine|Colchicine will be given to open heart surgery patients
15982835|NCT03015831|Drug|Placebo Oral Tablet|Placebo Oral Tablet will be given to open heart surgery patients according to randomization
15982837|NCT03015805|Behavioral|Contingency Management|"Contingency Management (CM) utilizes behavior modification & cognitive behavioral strategies to target adolescent alcohol or other drug (AOD) use. Protocol components are as follows: (a) The provider introduces CM to the family and engages them in the intervention; (b) The provider conducts Antecedent-Behavior-Consequence (ABC) assessments of the youth's AOD use with the youth and caregiver; (c) Based on the results of the ABC assessments, self-management planning and drug refusal skills training are implemented by the provider in collaboration with the caregiver; (d) Concurrently, a point and level system contract is filled in by the family, which provides rewards/privileges for negative drug and alcohol tests and disincentives (e.g., extra chores) for positive tests. Until continued abstinence is achieved, components b through d are repeated; (e) The provider collaborates with the family to develop plans for sustaining long-term abstinence. Typical duration of CM is 12-16 weeks."
15982838|NCT03015805|Behavioral|Probation as Usual|Standard services that a young person would receive while under probation supervision in the state of Oregon.
15982839|NCT03015792|Drug|Dexamethasone|Given PO
15982840|NCT03015792|Drug|Ibrutinib|Given PO
15982841|NCT03015792|Other|Laboratory Biomarker Analysis|Correlative studies
15982842|NCT03015792|Drug|Lenalidomide|Given PO
15982843|NCT03015792|Other|Pharmacological Study|Correlative studies
15982844|NCT03015792|Other|Quality-of-Life Assessment|Ancillary studies
15982845|NCT03015779|Other|cultured autologous oral mucosal epithelial cell sheet|a prospective study,Before and after self control
15982846|NCT03015766|Other|auricular acupressure therapy|Auricular acupressure, is a therapeutic method in which specific acupoints on the ear are stimulated to treat various disorders of the body. This practice is based on the theory that there are specific points on the auricle which correspond to major organs or systems of the body; and therapeutic effect on the corresponding target organ or system can be exerted by manipulating auricular acupoints. Auricular acupressure applies stimulation through pressure on specific acupoints by the imbedded beads, usually Semen Vaccaria (Wang Bu Liu Xing) or stainless steel beads. This therapeutic method is non-invasive and can be self-manipulated by the recipients at times required.
15982847|NCT03015766|Other|sham auricular acupressure therapy|The intervention is the same as that in the experimental group only when the points are five Helix points (HX 5-9). These points are clearly remote from the inner ear area and have no evidence for insomnia treatment.
15982848|NCT03015753|Behavioral|Tai Chi training|The 12-week Tai Chi training will be prescribed with three 1-hour instructor-led sessions and two 1-hour self-practice sessions per week. A modified 32-short form Yang-style Tai Chi Chuan will be adopted. The instructor-led sessions will be operated by qualified Tai Chi masters. The training activity will be delivered in group. The group size is 15 to 18 persons.
15982849|NCT03015753|Other|Waiting list control group|At the end of the trial, participants in this arm will be offered Tai Chi training similar as Tai Chi training (TC) group.
15982850|NCT03015740|Other|Laboratory Biomarker Analysis|Correlative studies
15982851|NCT03015740|Biological|Nivolumab|Given IV
15982852|NCT03015740|Other|Quality-of-Life Assessment|Ancillary studies
15982853|NCT03015740|Other|Questionnaire Administration|Ancillary studies
15982854|NCT03015740|Drug|Sitravatinib|Given PO
15982855|NCT03015727|Drug|Docetaxel|3 cycles of DOC neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2.
15982856|NCT03015727|Drug|Cisplatin|3 cycles of DDP neoadjuvant chemotherapy at day1,22 and 43 with cisplatin 75mg/m2.
15982857|NCT03015727|Radiation|IMRT/TOMO|intensity modulated radiation therapy or tomotherapy
15982858|NCT03015727|Drug|Chemotherapy|2 cycles of cisplatin concurrent chemotherapy at day 64 and 85 with cisplatin 100mg/m2.
15982859|NCT03015714|Other|MIRT|MIRT consists of a 4-week rehabilitation program in a hospital setting, which entails four daily sessions of physical therapy for five days and one hour of physical exercise on the sixth day. On the seventh day the patient rests. The duration of each session, including recovery periods, is about one hour. The first session consists of a one-to-one session with a physical therapist. The second session includes aerobic exercises to improve balance and gait, using different devices: a stabilometric platform with visual cues, a treadmill plus and a cycloergometer. The third session consists of occupational therapy, the fourth one includes one hour of speech therapy.
15982860|NCT03015714|Other|MIRT-AT|Patients in the MIRT-AT group will undergo the land-based therapy described in MIRT plus three sessions per week (Monday, Wednesday, Friday) of aquatic therapy. On days of aquatic therapy the first session of MIRT was not provided. The aquatic therapy program included aerobic exercises and physical activities to improve balance, motor skills, coordination and joints mobility. The water sessions were divided into 3 phases: i) Warm Up Exercises, ii) Central session Training, iii) Cool-down.
15982861|NCT03015701|Drug|Mifepristone|a 19 norsteroid with anti-progesterone and anti glucocorticoid activity which competitively inhibits binding of the hormone to its receptor
15982862|NCT03015701|Other|Placebo|placebo matching mifepristone
15982863|NCT03015688|Radiation|x-ray images|
15982864|NCT03015675|Drug|ascorbic acid|20g/day, D1-3, every 2 weeks
15982865|NCT03015675|Drug|mFOLFOX6|"mFOLFOX6
~Oxaliplatin 85 mg/m² d1 concurrent with
~Leucovorin 400 mg/m², followed by
~Bolus 5FU 400 mg/m² , followed by
~Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks"
15982866|NCT03015662|Other|Dry Needling Therapy|Dry needling procedures will be performed in the following pairs of muscles in the same intervention: occipital, splenius capitis, sternocleidomastoid (Clavicular branch TrPs 1, 2 and 3; sternal branch TrPs 1, 2, 3 and 4), scalene (anterior TrPs 1, and 2; medial TrP (Trigger Point) 1; posterior TrP 1), trapezius (upper TrPs 1, and 2; middle TrPs 5, 6 and 7; lower TrPs 3, and 4), supraspinatus (central point; myotendinous union; tendon insertion), infraspinatus (medial/superior; lateral/superior; lateral scapular side; medial scapular side), and multifidus (level C6).
15982867|NCT03015662|Other|Myofascial Release Therapy|Patients will develope a myofascial therapy protocol, administered in the following order in the same intervention: deep fascia release in temporal region, suboccipital release, compression-decompression of temporomandibular joint, global release of cervicodorsal fascia, release of pectoral region, diaphragm release (transverse slide), and transverse diaphragmatic plane.
15982868|NCT03015649|Device|SAVI SCOUT Surgical Guidance System|SAVI SCOUT Surgical Guidance System is a non-wire system, which uses nonradioactive light-activated radar, to provide breast surgeons with real-time guidance to locate and remove the target lesion in the breast and/or axillary tissue.
15982869|NCT03015636|Behavioral|Adjusted CBT-i for ADHD|This is a version of CBT for insomnia (CBT-i) developed during the pilot phase of this Project. Traditional CBT-i is adjusted for use in the adult ADHD population. This behavioral intervention adresses not only traditional aspects of insomnia, but also sleep phase problems and other aspects of sleep specifically relevant to the ADHD-population. Treatment is given as 10 weekly group sessions with telephone calls from the therapist between sessions to increase adherence and adress individual patient needs.
15982870|NCT03015636|Other|Treatment as Usual|Usual care at the ADHD-clinic. This mostly entails managing pharmacological treatment for ADHD, comorbid psychiatric problems and/or sleep problems. The clinic also provides different group treatments, for instance mindfulness groups and groups for developing behavioral strategies for managing ADHD symptoms, and individual therapy.
15982871|NCT03015623|Biological|SBI-101|SBI-101 is a biologic/device combination product that combines two components: allogeneic human mesenchymal stromal cells (MSCs) and an FDA-approved plasmapheresis device. SBI-101 is administered via integration into a Continuous Renal Replacement Therapy circuit and is designed to regulate inflammation and promote repair of injured tissue.
15982872|NCT03015623|Device|Sham|The sham control is an FDA-approved plasmapheresis device, without MSCs, which is integrated into a Continuous Renal Replacement Therapy circuit.
15982873|NCT03015610|Drug|commercially available lansoprazole|these participants will receive a one-time dose of lansoprazole followed by PK analysis and then once daily lansoprazole for 24 weeks
15982874|NCT03015610|Drug|matched placebo|these participants will receive a one-time dose of lansoprazole followed by PK analysis and then once daily placebo for 24 weeks
15982875|NCT03015597|Behavioral|Contingency Management|Contingency management is a behavioural intervention based on the principals of operant conditioning that is widely used in the addictions field. At the most basic level, contingency management works by providing rewards as reinforcement for desired behaviours. In the current study, the desired behaviours are either attendance at the clinic and abstinence from tobacco smoking, or just attendance at the clinic, dependent on the arm of the trial that participants are randomised to. Participants in the experimental condition will receive shopping vouchers for attending the clinic and providing a breath CO recording of <10ppm. Participants in the control condition will receive shopping vouchers for attending the clinic, regardless of their breath CO recording results.
15982876|NCT03015571|Device|Esophagus inspection in Narrow Band imaging.|During the endoscope withdrawal after cardia examination NBI will be used for esophagus inspection.
15982877|NCT03015571|Device|Standard High definition endoscopy.|Whole procedure will be performed in standard High definition endoscopy.
15982878|NCT03015571|Device|Esophagus inspection in Narrow Band imaging and increased care.|During the endoscope withdrawal after cardia examination NBI will be used for esophagus inspection and with increased care of cervical inlet patches detection.
15982879|NCT03015571|Device|Standard High definition endoscopy and increased care.|Whole procedure will be performed in standard High definition endoscopy with increased care of cervical inlet patches detection.
15982880|NCT03015558|Device|transcranial direct current stimulation of opercular-insular cortex - anodal active tDCS session|transcranial direct current stimulations of opercular-insular cortex. Three sessions separated by a minimum of 2 weeks, with three different conditions: one session with anodal active tDCS, one with active control, and one with sham control.
15982881|NCT03015558|Device|transcranial direct current stimulation of opercular-insular cortex - active control session|transcranial direct current stimulations of opercular-insular cortex. Three sessions separated by a minimum of 2 weeks, with three different conditions: one session with anodal active tDCS, one with active control, and one with sham control.
15982882|NCT03015558|Device|transcranial direct current stimulation of opercular-insular cortex - sham control session.|transcranial direct current stimulations of opercular-insular cortex. Three sessions separated by a minimum of 2 weeks, with three different conditions: one session with anodal active tDCS, one with active control, and one with sham control.
15982883|NCT03015545|Device|paretic leg-control|standing on the vibration platform, with no vibration signals delivered.
15982884|NCT03015545|Device|paretic leg-WBV|standing on the vibration platform, with WBV at 30Hz, 1.5mm.
15982885|NCT03015545|Device|non-paretic leg-control|standing on the vibration platform, with no vibration signals delivered.
15982886|NCT03015545|Device|non-paretic leg-WBV|standing on the vibration platform, with WBV at 30Hz, 1.5mm.
15982891|NCT03015519|Drug|Albiglutide|30 mg of lyophilized albiglutide will be delivered from a prefilled dual chamber glass cartridge (DCC). The pen injector system will deliver 0.5 mL albiglutide as a single subcutaneous injection once a week.
15982892|NCT03015519|Drug|Placebo|Matching placebo will be delivered from a prefilled dual chamber glass cartridge DCC. The pen injector system will deliver 0.5 mL matching placebo as a single subcutaneous injection once a week.
15982893|NCT03015506|Other|Bread|
15982894|NCT03015493|Other|Neural mobilization combined with traction|Neural mobilization techniques combined with cervical traction for the cervical nerve roots
15982895|NCT03015493|Other|Traction|Traction techniques for the cervical spine
15982896|NCT03015480|Behavioral|Remote counseling|For an 8 week period, patients will be asked to enter dietary information into the MyFitnessPal mobile application or website. Dietitians will access this information and provide personalized motivational interview phone calls on a weekly basis. After the initial 8 weeks, patients will receive a dietitian follow-up phone call around 5 and 11 months later.
15982897|NCT03015467|Other|Fecal Microbiota Transplantation|Fecal Microbiota Transplantation and the traditional treatments for Acute Pancreatitis with gut mucosal barrier dysfunction and unbalance of gut microflora in part 1
15982898|NCT03015467|Other|normal saline|normal saline and the traditional treatments for Acute Pancreatitis with gut mucosal barrier dysfunction and unbalance of gut microflora in part 2
15982899|NCT03015454|Other|Severe Sepsis Prediction|Upon receiving an InSight alert, healthcare provider follows standard practices in assessing possible (severe) sepsis and intervening accordingly.
15983046|NCT03014414|Behavioral|Weight Watchers|Focus on losing weight first via convenient meetings and personalized online tools
15982900|NCT03015454|Other|Severe Sepsis Detection|Upon receiving information from the severe sepsis detector in the UCSF electronic health record, healthcare provider follows standard practices in assessing possible (severe) sepsis and intervening accordingly.
15982901|NCT03015441|Other|Milk product fermented by lactic bacteria or not fermented|2 pots of 125g consumed daily during 28 days
15982902|NCT03015428|Other|psychoeducation|Providing knowledge and skills development in family caregivers of people with dementia, through a structured psychoeducational programme
15982903|NCT03015415|Procedure|Elbow Open Arthrolyses|Elbow arthrolysis by posterior access
15982904|NCT03015415|Procedure|Non-surgical intervention|Rehabilitation with splinting protocols
15982905|NCT03015402|Drug|Sodium Nitrite|40 mg PO (by mouth) TID (three times each day) for 10 weeks
15982906|NCT03015402|Drug|Placebo Oral Capsule|Placebo capsule that is of identical size, shape, and color to experimental drug capsule PO (by mouth) TID (three times each day) for 10 weeks
15982907|NCT03015389|Procedure|Diagnostic Test|WATS3D brush biopsy
15982908|NCT03015350|Drug|Sevoflurane|Measurement of blood desflurane level during one lung ventilation
15982909|NCT03015350|Drug|Desflurane|Measurement of blood desflurane level during one lung ventilation
15982910|NCT03015337|Behavioral|New physical education instructions|
15982911|NCT03015324|Drug|Hydroxychloroquine|Hydroxychloroquine
15982912|NCT03015311|Drug|Intensive BP control|For all participants, Olmesartan Medoxomil tablets or Amlodipine Besylate tablets will be used as an initial therapy. Other drugs, including hydrochlorothiazide and β-blockers, are allowed, in order to achieve the SBP target. If the target BP level is not achieved during the Follow-up periods, adjustment of drug type and dosage will be carried out according to procedures defined in the protocol.
15982913|NCT03015311|Drug|Standard BP control|For all participants, Olmesartan Medoxomil tablets or Amlodipine Besylate tablets will be used as an initial therapy. Other drugs, including hydrochlorothiazide and β-blockers, are allowed, in order to achieve the SBP target. If the target BP level is not achieved during the Follow-up periods, adjustment of drug type and dosage will be carried out according to procedures defined in the protocol.
15982914|NCT03015298|Device|PET/MRI|The recruited patients will receive a PET/MRI examination to evaluation the stage and resectability of the cancer.
15982915|NCT03015298|Device|PET/CT|At the next day of PET/MRI examination,A PET/CT examination will be performed.
15982916|NCT03015285|Behavioral|Cognitive Behavioural Therapy|A type of talk therapy called cognitive behaviour therapy (CBT) will be delivered to both groups.
15982917|NCT03015272|Behavioral|Auditory-Motor Mapping Training|AMMT is a novel, intonation-based intervention that is accompanied by simultaneous tapping each spoken syllable on tuned drums, designed to help minimally verbal children between the ages of 5.5 and12.0 years develop and/or improve speech output. AMMT is administered 1-on-1 for 45 min./day, 5 days/week (25 sessions) by researchers trained in the method.
15982918|NCT03015272|Behavioral|Speech-Repetition Therapy|SRT is a novel, non-intonation-based intervention designed to help minimally verbal children between the ages of 5.5 and 12 years develop and/or improve speech output. SRT is administered 1-on-1 for 45 min./day, 5 days/week (25 sessions) by researchers trained in this intervention. SRT serves as a control intervention to AMMT.
15982919|NCT03015259|Drug|Budesonide/Formoterol fumarate dihydrate|Experimental: Treatment 1
15982920|NCT03015259|Drug|Symbicort|Active Comparator: Treatment 2
15982921|NCT03015259|Drug|Placebo|Placebo Comparator: Treatment 3
15982922|NCT03015246|Drug|Extended release morphine|Dose (tailored to each participant based on his/her pre-experimental opioid use amount) is administered in 3 divided daily doses.
15982923|NCT03015246|Drug|Buprenorphine/Naloxone low dose|Buprenorphine/Naloxone dose of 1.4/0.36 mg/day
15982924|NCT03015246|Drug|Buprenorphine/Naloxone moderate dose|Buprenorphine/Naloxone dose of 4.2/1.08 mg/day
15982925|NCT03015246|Drug|Buprenorphine/Naloxone high dose|Buprenorphine/Naloxone dose of 12.8/3.16 mg/day
15982926|NCT03015246|Drug|Active stressor|Yohimbine hydrochloride 60mg + Hydrocortisone 20mg tablet
15982927|NCT03015246|Drug|Placebo stressor|Lactose
15982928|NCT03015220|Drug|Semaglutide|Oral administration once-daily, as add-on to pre-trial oral antidiabetic drug (OAD).
15982929|NCT03015220|Drug|Dulaglutide|Subcutaneously administration (s.c., under the skin) once-weekly, as add-on to pre-trial oral antidiabetic drug (OAD).
15982930|NCT03015207|Drug|NNC0194-0499|
15982931|NCT03015207|Drug|Placebo|
15982932|NCT03015194|Device|Edwards SAPIEN 3 transcatheter heart valve|"Used to relieve aortic stenosis in patients with symptomatic heart disease
~In this study it is not used for aortic stenosis-----the device is used in the mitral valve position."
15982933|NCT03015194|Device|ASHI INTECC Astato XS 20|"The Astato 0.014 guidewire is used for transcatheter electrosurgery in two steps in this procedure. First it is used for leaflet traversal during electrification. This procedure is similar to the use of the Astato XS20 and an amputated Asahi Confienza Pro 12 in the transcaval IDE investigation recently published. Second, the midshaft is focally denuded and electrified for the leaflet traversal step."
15982934|NCT03015181|Biological|VRC-HIVMAB075-00-AB|VRC07-523LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.
15982935|NCT03015168|Radiation|capecitabine and concurrent intensity modulated radiotherapy|patients with rectal cancer undergoing capecitabine and concurrent intensity modulated radiotherapy
15982936|NCT03015155|Procedure|Infusion of Cold Saline into Local Infarction Myocardium.|Infusion of Cold Saline into the Area of Ischemic Myocardium by Using Aspirated Catheter Before the Ischemia/reperfusion.
15982937|NCT03015142|Device|New image-guidance software|Patients in this group had spine surgery with new image-guidance software application
15982938|NCT03015129|Drug|Durvalumab|
15982939|NCT03015129|Drug|Tremelimumab|
15982940|NCT03015116|Other|Stretching|Daily foot and ankle stretching protocol
15982941|NCT03015116|Other|Cryotherapy|Daily cryotherapy in conjunction with stretching
15982942|NCT03015116|Device|Photobiomodulation Low Power|Photobiomodulation treatment with 10W power output
15982943|NCT03015116|Device|Photobiomodulation High Power|Photobiomodulation treatment with 25W power output
15983048|NCT03014401|Procedure|Arthroscopic debridement only|standard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal.
15982944|NCT03015103|Device|Intimate Lubrificant Gel|All the volunteers will receive the application of four dressings (3 placebos and 1 containing the tested product). After a certain period of time, photoirritation and photosensitization will be measured through the evaluation of tested region.
15982945|NCT03015090|Drug|Theophylline|After oral theophylline 200mg per day for one week, blood sample will be collected for determining plasma concentrations of theophylline and it's metabolites and the genotypes of CYP1A2
15982946|NCT03015077|Dietary Supplement|oral glutamine|L-Glutamine and maltodextrin are both nutritional supplements. In the glutamine arm: 10 g L-Glutamine and 5 g maltodextrin. The patients take their supplements three times a day during the period: 7 days before radiotherapy to 14 days after radiotherapy.
15982947|NCT03015077|Dietary Supplement|placebo|in the placebo arm: 15 g maltodextrin. The patients take their supplements three times a day during the period: 7 days before radiotherapy to 14 days after radiotherapy.
15982948|NCT03015077|Radiation|Radiotherapy|All patients undergo radiotherapy. 5 days a week. All patients had a dental evaluation for good oral hygiene prior to computed tomography simulation for radiotherapy. Post-operative patients received planned course of adjuvant treatment of 60 to 66 Gy in 2-Gy fractions to the surgical bed. The course of radiation was initiated no more than 6 weeks after resection. Patients without operation received definitive treatment to 70 Gy in 2-Gy fractions.
15982949|NCT03015064|Other|Myocardial Infarction|Observational study of myocardial Infarction patients
15982950|NCT03015051|Drug|Oxygen|
15982951|NCT03015025|Genetic|Acenocoumarol|A blood sample was collected for CYP2C9, VKORC1, CYP4F2, APOE and 2 variants of POR genotypes.
15982952|NCT03015012|Genetic|Personalized Nutrigenomics Testing (PNT)|Participants will receive nutrition counselling from a registered dietitian based on the results of their personalized nutrigenomics testing. Nutrition and physical activity counselling will focus on weight management. Individuals recruited from The East Elgin Family Health Team will complete the GLB Program, but will be given personalized nutrition and physical activity advice based on the results of their nutrigenomics test. Transplant participants will receive a monthly follow-up email or phone call reviewing their nutrition and physical activity plan, until 12 months after baseline data collection. Reminders of lifestyle goals will be incorporated into the GLB Program for participants at the East Elgin Family Health Team.
15982953|NCT03015012|Other|Standard Nutrition Intervention (SNI)|Transplant participants will receive standard nutrition counselling from a registered dietitian focused on strategies from the Canadian Diabetes Association's patient resource 'Just the Basics.' Nutrition and physical activity counselling will focus on weight management. Individuals recruited from The East Elgin Family Health Team will complete the standard GLB Program. Transplant participants will receive a monthly follow-up email or phone call reviewing their nutrition and physical activity plan, until 12 months after baseline data collection. Reminders of lifestyle goals will be incorporated into the GLB Program for participants at the East Elgin Family Health Team.
15982954|NCT03014999|Device|High frequency rTMS (repetitive Transcranial Magnetic Stimulation)|Higher cortical representation area of first right dorsal interosseous muscle will be determined through a figure-eight coil connected to the magnetic stimulator (Rapid2, Magstim, UK) held manually and at 45 degrees from the midline over the right primary motor cortex (C3 - 10/20 System). Then, will be determined the rest motor threshold by finding the lowest stimulator output that elicit motor evoked potential at least 50μV. After determined the RMT, the coil will be positioned over the scalp (Cz - 10/20 System). Thereafter, RMT will be measure. rTMS protocols was based on previous studies. High frequency protocol: 10Hz, 90% RMT, 45 trains, 40 stimuli per train, inter interval of 28s, 1800 stimuli. After each rTMS session, presence of adverse effects will be computed.
15982955|NCT03014999|Device|Low frequency rTMS (repetitive Transcranial Magnetic Stimulation)|Initially, the higher cortical representation area (hotspot) of first right dorsal interosseous (FDI) muscle will be determined through a figure-eight coil connected to the magnetic stimulator (Rapid2, Magstim, UK) held manually and at 45 degrees from the midline, will be placed over the right primary motor cortex (C3 - 10/20 System). Then, will be determined the rest motor threshold (RMT) by finding the lowest stimulator output that elicit motor evoked potential (MEP) at least 50 microvolts (μV). After determined the RMT, the coil will be positioned over the scalp (Cz - 10/20 System). Thereafter, RMT will be measure. Low frequency protocol: 1Hz, 90% RMT, 1500 stimuli (1 train). After each rTMS session, presence of adverse effects will be computed
15982956|NCT03014999|Device|sham rTMS (repetitive Transcranial Magnetic Stimulation)|The hotspot of first right dorsal interosseous (FDI) muscle will be determinate through a figure-eight coil connected to the magnetic stimulator positioned over the motor primary cortex (C3). Then, the motor threshold (RMT) of FDI will be measure. Sham rTMS will be performed with low frequency (1Hz, 90% RMT, 1500 stimuli) protocol using two coils. The first one - connected to the stimulator - will be positioned on a coil support close to the volunteer but not visible. Therefore, characteristic stimulation noises will be audible. The second - disconnected to the stimulator - will be placed over primary motor area Cz. After each rTMS session, presence of adverse effects will be computed.
15982957|NCT03014973|Biological|intra-prostatic concentration of sexual steroids|
15982958|NCT03014973|Procedure|Trans-rectal biopsy|
15982959|NCT03014960|Other|Online Cognitive Behavioral Therapy for Insomnia (CBT-I)|CBT-I is a psychological treatment designed to break the patterns of maladaptive thinking and behavior that maintain insomnia. CBT-I includes a range of techniques including a behavioral component (stimulus control, sleep restriction, relaxation) combined with a cognitive component (managing sleep related worries, the racing mind and intrusive thoughts) and an educational (sleep hygiene) component.
15982960|NCT03014947|Drug|MSB11022|Subjects will receive single dose of 40 milligram (mg) MSB11022 as a subcutaneous injection in the lower abdomen on Day 1.
15982961|NCT03014947|Drug|US-licensed Humira|Subject will receive single dose of 40 mg US-licensed Humira as a subcutaneous injection in the lower abdomen on Day 1.
15982962|NCT03014947|Drug|EU-approved Humira|Subject will receive single dose of 40 mg EU-approved Humira as a subcutaneous injection in the lower abdomen on Day 1.
15982963|NCT03014921|Other|iron injection|Injection of a 250mL saline solution added with 500mg of iron (Ferinject)
15982964|NCT03014921|Other|saline solution injection|Injection of a 250mL saline solution
15982965|NCT03014908|Other|Blood sampling|Determine the metabolic phenotype of blood plasma by proton-NMR spectroscopy
15982966|NCT03014895|Drug|Placebo|Intravenous infusion
15982967|NCT03014895|Drug|E3112|Intravenous infusion
15982969|NCT03014869|Device|High flow nasal cannula|High flow nasal cannula (HFNC) is a new emerging noninvasive respiratory support technology, which mainly includes high flow (15-60 L/min) device, heating humidification device and nasal cannula for high flow. A large number of physiological studies confirmed that HFNC has the following critical physiological effects: promoting airway humidification, improving tolerance of treatment, reducing the physiological dead space on the upper respiratory tract, producing a certain level of positive end expiratory pressure (2-7 cmH2O), decreasing the work of breathing and so on.
15982970|NCT03014856|Other|Blood sampling|Determine the metabolic phenotype of blood plasma by proton-NMR spectroscopy
15982971|NCT03014843|Drug|Naloxone|20µg/kg/h intravenous infusion after 0.4mg bolus of Naloxone and 0.6mL IM NaCl (0.9%) injection (this step is necessary to keep the subject blinded for the condition since nalaxone and methylnaltrexone have different administration routes)
15982972|NCT03014843|Drug|Methylnaltrexone Bromide|12mg/0.6mL subcutaneous injection and 1mL bolus of NaCl (0.9%) followed by intravenous infusion (this step is necessary to keep the subject blinded for the condition since nalaxone and methylnaltrexone have different administration routes)
15982973|NCT03014843|Other|Placebo|0.6 mL of NaCl 0.9% will be injected IM and 1mL bolus injection of NaCl(0.9%) will be administered IV followed by IV NaCl 0.9% infusion
15982974|NCT03014830|Drug|Alirocumab|150 mg SQ every 2 weeks
15982975|NCT03014830|Drug|Placebos|Placebo injections SQ every 2 weeks
15982976|NCT03014817|Procedure|Ultrasonically activated scalpel|Dissection with ultrasonically activated scalpel
15982977|NCT03014817|Procedure|Electrocautery|Dissection with electrocautery
15982978|NCT03014804|Biological|autologous dendritic cells pulsed with tumor lysate antigen Vaccine|Given ID
15982979|NCT03014804|Other|Laboratory Biomarker Analysis|Correlative studies
15982980|NCT03014804|Biological|Nivolumab|Given IV
15982981|NCT03014804|Other|Quality-of-Life Assessment|Ancillary studies
15982982|NCT03014804|Other|Questionnaire Administration|Ancillary studies
15982983|NCT03014791|Other|Brief lifestyle/medical history questionnaire|Core Measurement
15982984|NCT03014791|Other|Anthropometric measures|Core Measurement
15982985|NCT03014791|Other|Blood pressure and arterial stiffness|Core Measurement
15982986|NCT03014791|Other|Cardiac output and lung function|Core Measurement
15982987|NCT03014791|Other|Heart rate variability|Core Measurement
15982988|NCT03014791|Other|Blood sample & spot urine sample|Core Measurement
15982989|NCT03014791|Other|24 hour ambulatory blood pressure monitor|Detailed Measurement (Optional for participants).
15982990|NCT03014791|Other|24 hour urine collection|Detailed Measurement (Optional for participants).
15982991|NCT03014791|Other|Echocardiograph: Left ventricular mass|Detailed Measurement (Optional for participants).
15982992|NCT03014791|Other|Large artery structure: Carotid intima-media thickness|Detailed Measurement (Optional for participants).
15982993|NCT03014791|Other|Small artery structure: Minimum forearm vascular resistance|Detailed Measurement (Optional for participants).
15982994|NCT03014791|Other|Large artery endothelial function|Flow- and salbutamol-mediated vasodilatation Detailed Measurement (Optional for participants).
15982995|NCT03014791|Other|Small artery endothelial function: Forearm blood flow|Detailed Measurement (Optional for participants).
15982996|NCT03014791|Other|Dundee step test|Systolic blood pressure response to submaximal exercise Detailed Measurement (Optional for participants).
15982997|NCT03014791|Other|Detailed haemodynamic response to submaximal exercise|Detailed Measurement (Optional for participants).
15982998|NCT03014791|Other|Cardiopulmonary fitness: Maximum oxygen consumption|Detailed Measurement (Optional for participants).
15982999|NCT03014791|Other|Haemodynamic response to mental stress|Detailed Measurement (Optional for participants).
15983000|NCT03014791|Other|Small artery dilatory function: Forearm blood flow|Detailed Measurement (Optional for participants).
15983001|NCT03014778|Drug|The Chlorhexidine gluconate 0.05%|Washing vagina pre- operatively with Chlorhexidine gluconate 0.05%
15983002|NCT03014778|Drug|10% Povidone iodine|Washing vagina pre- operatively with 10% Povidone iodine
15983003|NCT03014765|Other|EDOP|no intervention
15983004|NCT03014752|Other|Classical ketogenic diet|The classical ketogenic diet with a ratio of 4 to 1 (4:1), each 4 grams of fat to each gram of carbohydrate plus protein, will be introduced gradually.
15983005|NCT03014752|Other|Modified Atkins diet|The modified Atkins diet with a ratio of 1 or 2 to 1 (1:1, 2:1), each 1 or 2 grams of fat to each gram of carbohydrate plus protein, will be introduced gradually.
15983006|NCT03014739|Other|Supersonic ShearWave Elastography|ShearWave Elastography (SWE) is part of routine ultrasound examination
15983007|NCT03014726|Device|Urotronic Drug Coated Balloon (DCB)|Urotronic Drug Coated Balloon (DCB) is a catheter with a tapered atraumatic tip. The distal end of the catheter has a semi-compliant inflatable balloon coated with a proprietary coating containing the drug and carriers.
15983008|NCT03014713|Drug|Dezocine|Dezocine 0.01mg/kg/h intravenous administration during the first two days after surgery.
15983009|NCT03014713|Drug|Flubiprofen|Flubiprofen 0.5mg/kg/h intravenous administration during the first two days after surgery.
15983010|NCT03014713|Drug|Dexmedetomidine|Dexmedetomidine 0.1μg/kg/h intravenous administration during the first two days after surgery.
15983011|NCT03014700|Biological|Fibrinogen Concentrate|Subject will be administered Fibrinogen Concentrate to control bleeding after open heart surgery when randomized to Fibrinogen Concentrate group
15983012|NCT03014700|Biological|Cryoprecipitate|Subject will be administered Cryoprecipitate to control bleeding after open heart surgery when randomized to Cryoprecipitate group
15983013|NCT03014687|Drug|Placebo|PO BID placebo for 7 days. Postoperative days 1 through 7: patients will administer saline spray (e.g., Ocean nasal spray) to both nostrils four times daily. Postoperative days 8 through 30: patients will begin twice daily sinus irrigation rinse (e.g., Neti-pot) until day 30. After day 30, patients will perform sinus irrigation as needed. If a patient is unable to tolerate nasal rinses, saline spray can be used as an alternative.
15983047|NCT03014401|Procedure|Arthroscopic debridement with stem cell transplantation|Autologous fat pad harvest and transplantation of cells after standard arthroscopic treatment consisting of: partial meniscectomy, synovectomy, chondroplasty, loose body removal.
15983014|NCT03014687|Drug|Oral Antibiotics cefdinir or trimethoprim/sulfamethoxazole|Oral antibiotics (cefdinir [Omnicef®] 300 mg PO BID or trimethoprim/sulfamethoxazole [Bactrim DS™] PO BID for cephalosporin intolerant patients) for 7 days.Postoperative days 1 through 7: patients will administer saline spray (e.g., Ocean nasal spray) to both nostrils four times daily. Postoperative days 8 through 30: patients will begin twice daily sinus irrigation rinse (e.g., Neti-pot) until day 30. After day 30, patients will perform sinus irrigation as needed. If a patient is unable to tolerate nasal rinses, saline spray can be used as an alternative.
15983015|NCT03014674|Biological|Lyophilized mepolizumab|Mepolizumab will be provided as white, uniform, lyophilized cake in vials with unit dose strength of 100 mg/vial for reconstitution in 1.2 mL sterile water for injection (SWFI). Following reconstitution it forms a clear to opalescent, colorless to pale yellow solution for SC injection.
15983016|NCT03014674|Biological|Liquid mepolizumab|Mepolizumab will be provided as a clear to opalescent, colorless to pale yellow sterile solution for SC injection, supplied in a single-use, prefilled autoinjector or safety syringe containing 100 mg/mL mepolizumab with sodium phosphate, citric acid, sucrose ethylenediaminetetraacetic acid and polysorbate 80.
15983017|NCT03014674|Device|Prefilled autoinjector|Single use, disposable autoinjector will be assembled with the prefilled syringe containing the drug product. It will enable automatic delivery of the drug product under the power of a spring mechanism following activation of the device. Start and end of injection clicks will inform the user of correct use. A plastic needle will cover shield the needle before and after injection to minimize the potential for needle stick injuries.
15983018|NCT03014674|Device|Prefilled Safety Syringe|Single use, disposable safety syringe with a retracting needle guard and locking system.
15983019|NCT03014661|Other|Quality of life under or after therapy with Pollinex quattro|To measure Quality of life using the DLQI-index in year one, year two, year three or six month after therapy with Pollinex quattro plus.
15983020|NCT03014648|Drug|Atezolizumab|Atezolizumab will be administered through an IV over 60 minutes at a dose of 1200mg on Day 1 of each 21-day cycle. If the first dose is tolerated without any infusion-related adverse events, the following doses can be administered over 30 minutes.
15983021|NCT03014635|Biological|Botulinum Toxins, Type A|Intramuscular injection
15983022|NCT03014635|Biological|Placebos|Intramuscular injection
15983023|NCT03014622|Biological|Botulinum Toxins, Type A|Intramuscular injection
15983024|NCT03014622|Biological|Placebos|Intramuscular injection
15983025|NCT03014596|Other|Assert|The Assert-method is a counselling method used to assess and systematically follow up the individual adolescents' perceived needs.
15983026|NCT03014583|Device|Precision Spectra™ system|Neurostimulation procedures
15983027|NCT03014570|Behavioral|EIT-4-BPSD|This arm includes the four step intervention: 1. Assessment of the environment and policies; 2. Education of staff; 3. Establishing person-centered care plans; and 4. Mentoring and motivating staff. We provide the sites with a research nurse who works with an identified stakeholder group and champion within the facility and visits the settings monthly, connects by email weekly to complete the four intervention steps. The implementation process is guided by the Evidence Integration Triangle (EIT) framework. The EIT brings together evidence and key stakeholders from the facility to influence care practices. EIT includes: participatory implementation processes, provision of practical evidence-based interventions, and pragmatic measures of progress toward goals.
15983028|NCT03014570|Behavioral|Education-only Control|This arm includes step 2 only of the EIT-4-BPSD. Facilities are provided with education abouthow to provide behavioral interventions for behavioral symptoms associated with dementia. They can have the education face-to-face or via a powerpoint or webinar.
15983029|NCT03014557|Device|left atrial appendage closure device implantation|to permanently implant a WATCHMAN left atrial appendage closure device through trans-catheter approach
15983030|NCT03014544|Device|Computer- administered test battery|Participants in this observational study will only undergo sequential cognitive performance evaluations by computer- administered cognitive test battery.
15983031|NCT03014544|Device|Examiner- administered test battery|Participants in this observational study will only undergo sequential cognitive performance evaluations by examiner- administered cognitive test battery.
15983032|NCT03014531|Other|almond|
15983033|NCT03014531|Other|high-carbohydrate control food|
15983034|NCT03014518|Other|Clinical assessments and blood samples; follow-up for 12 mos|Kiddie-Sads Present and Lifetime Version Diagnostic Interview, Columbia-Suicide Severity Rating Scale, Suicidal Ideation Questionnaire, Children's Depression Rating Scale-Revised, Multidimensional Anxiety Scale for Children (2nd Ed), Adverse Childhood Experiences Questionnaire, Life Events Checklist-5, Pubertal Development Scale. All assessments administered at baseline, and a smaller subset of assessments administered at discharge and other time points throughout 12 months follow-up. Blood samples taken at baseline (admission to unit) and day of discharge.
15983035|NCT03014518|Other|Clinical assessments and blood samples; no 12mo follow-up|Kiddie-Sads Present and Lifetime Version Diagnostic Interview, Columbia-Suicide Severity Rating Scale, Suicidal Ideation Questionnaire, Children's Depression Rating Scale-Revised, Multidimensional Anxiety Scale for Children (2nd Ed), Adverse Childhood Experiences Questionnaire, Life Events Checklist-5, Pubertal Development Scale. All assessments administered at baseline, and a smaller subset of assessments administered at discharge time point (5-7 days after baseline). Blood samples taken at baseline and discharge time points (5-7 days after baseline).
15983036|NCT03014505|Biological|FMT|Fecal Microbiota Transplantation and the traditional treatments for Decompensated Cirrhosis in part 1
15983037|NCT03014505|Other|traditional treatments|traditional treatments for Decompensated Cirrhosis in part 2
15983038|NCT03014492|Device|Q Collar|Collar designed to mitigate slosh in the brain
15983039|NCT03014479|Drug|Trelagliptin|Trelagliptin 100 mg or 50 mg
15983040|NCT03014479|Drug|Daily DPP-4 inhibitor|Alogliptin, anagliptin, linagliptin, saxagliptin, sitagliptin, teneligliptin or vildagliptin
15983041|NCT03014466|Behavioral|Use of Video Projector|Bed mounted video projector that is used to play videos of the patient's choosing prior to induction of anesthesia
15983042|NCT03014466|Behavioral|Use of Video Tablet|7 inch video tablet that is used for displaying videos of the patient's choosing prior to induction of anesthesia
15983043|NCT03014440|Drug|Cannabidiol|
15983044|NCT03014427|Other|Biological Database|Biological Database
15983045|NCT03014414|Behavioral|Fun First|Learn key enjoyable maintenance skills before losing weight
15983049|NCT03014388|Other|autogenous bone|Autogenous bone graft (gold standard). sinus lift with autogenous bone.
15983050|NCT03014388|Other|Mineralized plasmatic matrix|By using venoud blood from the patient, together with bone graft, a centrifuge will be used to obtain the top layer after centrifuging blood at 3000 RPM.
15983051|NCT03014375|Drug|BIA-5-453|Each subject will receive a single oral dose of 100 μCi/ 3.7 MBq 14C labeled BIA 5-453 (600 mg).
15983052|NCT03014362|Device|Neuronetics NeuroStar XPLOR magnetic stimulator - Active|"Localization: Left prefrontal dorsolateral neocortex. Dose Delivery: Figure-8 solid core coil at 120% motor threshold, 10 Hz, 4 second train duration, 10 second interval for 30 minutes.
~Treatment Dose: ~4k/session, 12-15k/day, 36-45k total pulses. Sessions: 9 in total; 3/day for 3 consecutive days over and above SOC."
15983053|NCT03014362|Device|Neuronetics NeuroStar XPLOR magnetic stimulator - Sham|Localization: Left prefrontal dorsolateral neocortex. Sham Delivery: Figure-8 solid core coil rendered inert via blocking insert. Dose: Zero pulses. Sessions: 9 in total; 3/day for 3 consecutive days over and above SOC.
15983054|NCT03014349|Other|Analysis of medical records|Individuals with primary open-angle glaucoma and/or glaucoma suspects, selected from the electronic records of the VER Hospital. The following variables will be observed: gender, age, race, systemic diseases, intraocular pressure, type of glaucoma, complementary exams and degree of evolution. All patients were given a complete ophthalmologic examination, including Goldmann and pneumatic tonometry.
15983055|NCT03014336|Device|memsorb|memsorb is a CO2 filter replacing current chemical CO2 absorbers
15983056|NCT03014323|Drug|Galantamine|Galantamine 4 mg twice a day for 4 weeks
15983057|NCT03014323|Drug|Placebo|Placebo 1 capsule twice a day for 4 weeks
15983058|NCT03014310|Drug|AS03|AS03 oil-in-water emulsion adjuvant.
15983059|NCT03014310|Drug|MF59 adjuvant|Microfluoridized adjuvant 59 (MF59) is an oil-in-water emulsion.
15983060|NCT03014310|Biological|Monovalent Influenza A/H5N8 vaccine|Monovalent inactivated influenza A/H5N8 virus vaccine for IM injection. prepared from influenza virus propagated in chicken egg fluid using seed virus prepared from the candidate vaccine virus (CVV), influenza virus A/gyrfalcon/Washington/41088-6/2014(H5N8)-PR8-IDCDC-RG43A (abbreviated as IDCDC-RG43A).
15983061|NCT03014297|Drug|everolimus|everolimus
15983062|NCT03014297|Drug|fosbretabulin|fosbretabulin
15983063|NCT03014271|Behavioral|Sources of Strength (SOS) Prevention Program|Sources of Strength is an evidence based program for youth suicide that trains student key leaders to strengthen social connectedness and healthy norms school-wide and is listed on the National Registry of Evidence Based Programs and Practices (NREPP).
15983064|NCT03014258|Biological|NF54 P. falciparum malaria challenge|Aseptically-raised A. stephensi female mosquitoes infected with aseptically-raised P. falciparum parasites of the NF54 strain.
15983065|NCT03014232|Procedure|SLED-f with HCO dialyzer|Online SLED-f with high cut-off dialyzers were performed using the Fresenius 5008S hemodiafiltration machines (Fresenius Medical Care, Bad Homburg, Germany). Super-flux, Sureflux 150FH (Nipro Corporation, Osaka, Japan; cellulose triacetate material, pore size 78 A◦, Kuf 66.9 mL/hr/mmHg, surface area 1.5 m2) were used. Dialysis time and blood flow rate were 6 hours and 200 mL/min, respectively. The predilution reinfusion fluid rate and dialysate flow rate were 80 and 220 mL/min, respectively (the total dialysis fluid flow rate was 300 mL/min).
15983066|NCT03014232|Procedure|SLED-f with HF dialyzer|Online SLED-f with standard high-flux dialyzers were performed using the same Fresenius 5008S hemodiafiltration machines (Fresenius Medical Care, Bad Homburg, Germany). High-flux ELISIO 150H (Nipro Corporation, Osaka, Japan; polynephron material, pore size 50-60 A◦, Kuf 67 mL/hr/mmHg, surface area 1.5 m2) were used. Dialysis time and blood flow rate were 6 hours and 200 mL/min, respectively. The predilution reinfusion fluid rate and dialysate flow rate were 80 and 220 mL/min, respectively (the total dialysis fluid flow rate was 300 mL/min).
15983067|NCT03014219|Drug|Only 1 arm: treatment with MSC-AFP|Eligible patients will be treated with a fistula plug that has been coated with autologous mesenchymal stromal cell. Drug study. Single dose of 20 million cells.
15983068|NCT03014193|Device|Semiquantitative Multi-Level Pregnancy Test|
15983069|NCT03014180|Device|"In-Clinic LVAT"|Algorithm offers automatic threshold measurement of differents vectors of left ventricular stimulation.
15983070|NCT03014167|Drug|Albendazole|All eligible individuals will receive a single dose of 400 mg albendazole.
15983071|NCT03014154|Other|Training|
15983072|NCT03014141|Other|Oat bran (Oatwell 28)|11 g oat bran containing 3.1 gram oat beta-glucan
15983073|NCT03014141|Other|Maltodextrin|11 g of Maltodextrin
15983074|NCT03014128|Other|Clinical examination and data processing of questionnaires|xy
15983075|NCT03014115|Dietary Supplement|combination ARA + DHA|combination ARA + DHA supplemented infant formula
15983076|NCT03014115|Dietary Supplement|DHA|DHA supplemented infant formula
15983077|NCT03014102|Drug|Recombinant Human Thrombopoietin|Recombinant human Thrombopoietin is a full length glycosylated molecule identical to endogenous Thrombopoietin.
15983078|NCT03014089|Biological|mRNA-1325|Escalating dose levels
15983079|NCT03014089|Other|Placebo|
15983080|NCT03014076|Drug|GP2 peptide + GM-CSF vaccine plus trastuzumab|HLA-A2+/A3+ subjects are given the GP2 peptide vaccine plus trastuzumab
15983081|NCT03014076|Drug|Trastuzumab|HLA-A2-/A3- patients are followed as controls receiving trastuzumab only.
15983082|NCT03014050|Device|e-Tapper TT-R1|"The e-Tapper is a non-invasive, handheld electronic device designed to apply micro current stimulation to a person's hands at specified points representing various body parts, such as the head, leg, or foot. This is one form of Bio-Electro Stimulation Therapy known as the 11-point Hand Treatment System. The current delivered is less than one milliampere."
15983083|NCT03014037|Procedure|Unilateral Bone Marrow Procurement|A total of 61cc of bone marrow will be procured under ultrasound guidance from one posterior superior iliac spine (PSIS) via 3 passes, each at least 1 cm apart, through the bone cortex. In each pass, investigators will obtain 2.3cc of BMA with a 60cc syringes.
15983084|NCT03014037|Procedure|Bilateral Bone Marrow Procurement|30.5cc of bone marrow will be obtained under ultrasound guidance from each posterior superior iliac spine (PSIS) with 3 passes, at least 1 cm apart, per side (10.17cc per pass) using 60cc syringes. The collection from each PSIS will be combined to yield a total of 61cc.
15983085|NCT03014024|Other|Low-Level Laser Therapy|The laser is an infrared (invisible) 60 mW 904 nm, made by Irradia Midlaser
15983846|NCT03008733|Other|Electro myography surface nerves|Electro myography surface nerves
15983086|NCT03014024|Other|Placebo Low Level Laser therapy|This i laser is not giving any irradiation, but is identical to the infrared (invisible) 60 mW 904 nm Irradia Midlaser, made by Irradia.
15983087|NCT03014011|Other|Hypoglycaemic clamp|The clamp is performed by insulin and adjustable 20% glucose infusions, with the aim to lower and keep plasma blood glucose levels at 3 mmol/L for outcome measurements.
15983088|NCT03014011|Other|Euglycaemic clamp|The clamp is performed by insulin and adjustable 20% glucose infusions, with the aim to keep plasma blood glucose levels at 6 mmol/L for outcome measurements.
15983089|NCT03013998|Biological|Samalizumab (BAML-16-001-S1)|300 mg/m2, IV, on days 1, 3, and 24; followed by 300 mg/m2, IV, every 21 days for 2 years in the absence of toxicity or disease progression. Dose may be de-escalated to 150 mg/m2 or escalated to 600 mg/m2 based on occurrence of dose-limiting toxicity.
15983090|NCT03013998|Biological|BI 836858 (BAML-16-001-S2)|20 mg/m2, IV, on days 9, 16, and 23 of a 28-day cycle; followed 20 by mg/m2, IV, on days 1, 8, 15 and 22 of each 28-day cycle for 2 years in the absence of toxicity or disease progression (reduced to monthly administration in event of complete response or complete response with incomplete blood count recovery). Dose may be escalated to a maximum dose of 320 mg/m2 or de-escalated to 10 mg/m2 based on occurrence of dose-limiting toxicity.
15983091|NCT03013998|Other|Laboratory Biomarker Analysis|Molecular genomic assessment to assign patients to targeted therapy (sub-study) based on their specific subtype of acute myeloid leukemia
15983092|NCT03013998|Drug|Daunorubicin (BAML-16-001-S1)|60 mg/m2, IV, on days 4, 5, and 6 of the induction cycle
15983093|NCT03013998|Drug|Cytarabine (BAML-16-001-S1)|100 mg/m2, IV, on days 4 through 10 of the 24-day induction cycle; 1000 mg/m2, IV, on days 2, 4, and 6 of the consolidation cycle 1 and days 1, 3, and 5 of consolidation cycles 2 through 4
15983094|NCT03013998|Drug|Azacitidine (BAML-16-001-S2)|75 mg/m2, IV, on days 1 through 7 of each 28-day cycle for 2 years in the absence of toxicity or disease progression
15983095|NCT03013998|Drug|AG-221 (BAML-16-001-S3)|100 mg, oral, daily until time of intolerance or disease progression. Dose may be de-escalated to 50 mg based on occurrence of dose-limiting toxicity.
15983096|NCT03013998|Drug|Azacitidine (BAML-16-001-S3)|75 mg/m2, IV or SC, on days 1 through 7 of each 28-day cycle starting with cycle 6 and ending after 12 cycles for patients not attaining complete remission or complete remission with incomplete blood count recovery after 5 cycles of monotherapy with AG-221
15983097|NCT03013998|Drug|Entospletinib (BAML-16-001-S4)|200 mg, oral, twice daily for 5 years until time of intolerance or disease progression. Dose may be escalated to 400 mg.
15983098|NCT03013998|Drug|Azacitidine (BAML-16-001-S4)|75 mg/m2, IV or SC, on days 1 through 7 of each 28-day cycle and continuing for 12 cycles. Treatment starts after 1 cycle of monotherapy with entospletinib for patients not attaining complete remission or complete remission with incomplete blood count recovery or after later cycles of monotherapy with entospletinib for patients with disease progression.
15983099|NCT03013998|Drug|Entospletinib (BAML-16-001-S5)|400 mg, oral, twice daily for 2 years on study until time of intolerance or disease progression. Dose may be de-escalated to 200 mg twice daily or 200 mg once daily based on occurrence of dose-limiting toxicity.
15983100|NCT03013998|Drug|Decitabine (BAML-16-001-S5)|20 mg/m2, IV, on days 1 through 5 or 10 of each 28-day cycle and continuing for up to 11 cycles. During the first induction cycle, and the 2nd and 3rd induction cycles if they are needed, administration occurs on days 1 through 10 of each 28-day cycle. During subsequent consolidation, decitabine is administered on days 1 through 5 of each 28-day cycle and continuing for up to 11 cycles. Duration may be reduced by 1 day based on occurrence of dose-limiting toxicity, and patients may switch to entospletinib monotherapy maintenance at any time if they develop toxicity or are unwilling to continue decitabine during consolidation therapy.
15983101|NCT03013998|Drug|Entospletinib (BAML-16-001-S6)|400 mg, oral, twice daily for 2 years until time of intolerance or disease progression.
15983102|NCT03013998|Drug|Daunorubicin (BAML-16-001-S6)|60 mg/m2, IV, on days 1-3 or 1-2 of each 28-day cycle for the first and second induction cycle, respectively
15983103|NCT03013998|Drug|Cytarabine (BAML-16-001-S6)|100 mg/m2, IV, on days 1 through 7 or 1 through 5 of each 28-day cycle for the first and second induction cycle, respectively; then 1000 mg/m2 (patients ≥60 years) or 3000 mg/m2 (younger patients with creatinine clearance >30 mL/min and <50 mL/min), IV, every 12 hours on days 1, 3, and 5 of each 28-day cycle for up to 4 consolidation cycles
15983104|NCT03013998|Drug|Pevonedistat (BAML-16-001-S9)|20 mg/m2, IV, on days 1, 3, and 5 of each 28-day cycle and continuing for 24 cycles in the absence of toxicity or disease progression
15983105|NCT03013998|Drug|Azacitidine (BAML-16-001-S9)|75 mg/m2, IV or SC, on days 1 through 7 or days 1 through 5 and then 8 through 9 (based on institutional guidelines) of each 28-day cycle and continuing for 12 cycles in the absence of toxicity or disease progression
15983106|NCT03013998|Drug|AG-120 (BAML-16-001-S16)|500 mg, oral, daily until time of intolerance or disease progression. Dose may be de-escalated to 250 mg based on occurrence of dose-limiting toxicity.
15983107|NCT03013998|Drug|Azacitidine (BAML-16-001-S16)|75 mg/m2, IV or SC, on days 1 through 7 or days 1 through 5 and then 8 through 9 (based on institutional guidelines) of each 28-day cycle and continuing for 12 cycles in the absence of toxicity or disease progression
15983108|NCT03013998|Drug|Gilteritinib (BAML-16-001-S8 Group 1)|"120 mg, oral, daily, with treatment continuing based on bone marrow results at 28 and 56 days. Patients with partial response at 28 days continue treatment for an additional 28 days. Patients with complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) at 28 or 56 days continue treatment for 5 years until time of intolerance or disease progression. Patients with less than partial response at 28 days or partial response at 28 days followed by less than CR or CRi at 56 days proceed to combination treatment with decitabine or non-study alternative.
~The combination dose is 80 mg, oral, daily, for 5 years until time of intolerance or disease progression (patients who do not achieve CR or CRi after 3 cycles will discontinue study treatment). The combination dose may be escalated to 120 mg daily or de-escalated to 80 mg daily given after decitabine rather than in combination with decitabine based on absence or occurrence of dose-limiting toxicity."
15983132|NCT03013855|Device|FIT-SOC|Study subjects will be given a standard kit for fecal immunochemical test by their primary healthcare provider. As per standard practice, the patient will take the kit home and use the included FIT applicator to collect a stool sample from spontaneously passed stool during a regular bowel movement. The patient will then mail the stool sample to the lab in a pre-paid envelope, which is provided in the kit.
15983109|NCT03013998|Drug|Decitabine (BAML-16-001-S8 Group 1)|20 mg/m2, IV, on days 1 through 10 of each 28-day cycle and continuing for up to 3 cycles. Treatment starts after 1-2 cycles of monotherapy with gilteritinib if patients do not attain complete remission (CR) or complete remission with incomplete hematologic recovery (CRi) with monotherapy. Patients who do not achieve CR/CRi after 3 cycles of combination therapy will discontinue study treatment. If CR or CRi is obtained with combination therapy after 3 cycles, decitabine will be administered on days 1-5 of each subsequent 28-day cycle until progression, intolerance, or patient desire to discontinue therapy.
15983110|NCT03013998|Drug|AZD5153 (BAML-16-001-S10)|20 mg, oral, once daily during 7-day lead-in and then on days 1 through 21 of each 28-day cycle for up to 2 years or until allogeneic stem cell transplantation, time of intolerance, or disease progression [if the continuous administration AZD5153 on Days 1-21 of a 28-day cycle is not tolerated, an alternative schedule of 2 weeks on and 2 weeks off (i.e. AZD5153 will be administered on Days 1-14 of a 28-day cycle) will be explored]. Dose may be de-escalated to 10 mg or escalated to 30 mg based on occurrence of dose-limiting toxicity during phase 1 dose escalation. Starting with Cycle 2, patients may receive concomitant fluconazole, isavuconazole, or posaconazole and doses adjusted to 2, 5, or 8 mg daily. The Phase 1b expansion pharmacokinetics cohort will allow for posaconazole starting at Cycle 1 with AZD5153 dose adjusted from 10, 20, or 30 mg daily to 2, 5, or 8 mg daily. Phase 2 dose will be based on Phase 1 results.
15983111|NCT03013998|Drug|Venetoclax (BAML-16-001-S10)|400 mg, oral, on days 1 through 21 of each 28-day cycle and continuing for up to 12 cycles (for Cycle 1, day 1 dose will be 100 mg, day 2 dose 200 mg, and days 3 onward 400 mg). Starting with Cycle 2, patients may receive concomitant fluconazole or isavuconazole and daily doses adjusted to 200 mg, or posaconazole and daily doses adjusted to 70 mg. The Phase 1b expansion pharmacokinetics cohort will allow for posaconazole starting at Cycle 1 with Venetoclax dose adjusted to 10 mg on day 1, 20 mg on day 2, 50 mg on day 3, and 70 mg on day 4 onward).
15983112|NCT03013998|Drug|TP-0903 (BAML-16-001-S14)|37 mg, oral, once daily on days 1 through 21 of each 28-day cycle for up to 2 years to time of intolerance or disease progression. Dose may be de-escalated to as low as 12 mg or escalated to 50 mg based on occurrence of dose-limiting toxicity during Phase 1 dose escalation. Phase 2 dose will be based on Phase 1 results.
15983113|NCT03013998|Drug|Decitabine (BAML-16-001-S14)|20 mg/m2, IV, on days 1 through 5 or 10 of each 28-day cycle and continuing for up to 2 years to time of intolerance or disease progression. During the first induction cycle, and the 2nd and 3rd induction cycles if they are needed, administration occurs on days 1 through 10 of each 28-day cycle. During maintenance, decitabine is administered on days 1 through 5 of each 28-day cycle. Patients may switch to TP-0903 monotherapy maintenance if they develop toxicity or are unwilling to continue decitabine during maintenance therapy.
15983114|NCT03013998|Drug|Decitabine (BAML-16-001-S8 Group 2)|20 mg/m2, IV, on days 8 through 12 of the first 35-day induction cycle, then on days 1 through 5 of subsequent 28-day cycles and continuing for up to 60 cycles, disease progression, intolerance, or patient desire to discontinue therapy.
15983115|NCT03013998|Drug|Venetoclax (BAML-16-001-S8 Group 2)|Oral dosing based on concurrent antifungal use. Dose without use of concomitant antifungal is 400mg, dose if on posaconazole is 70mg, dose if on voriconazole is 100mg, and dose if on moderate CYP3A inhibitors (ie fluconazole, isavuconazole) is 200mg continuing for up to 12 total cycles. For the 35-day induction cycle 1, dosing is days 2 through 28. For the 28-day induction cycle 2, if needed, dosing is days 1 through 21. For the 28-day consolidation cycles, dosing is days 1-15.
15983116|NCT03013998|Drug|AZD5991 (BAML-16-001-S18)|150 mg, IV, on days 1, 4, 8, 11, 15, and 18 of three 28-day cycles; followed by 150 mg/m2, IV, on days 1, 4, 8, and 11 of twenty-one 28-day cycles; followed by 150 mg/m2 on days 1 and 4 of each 28-day cycle until time of progression, unacceptable toxicity, death, or 57 total cycles of treatment. Dose may be escalated to a maximum dose of 400 mg or de-escalated to 100 mg based on occurrence of dose-limiting toxicity.
15983117|NCT03013998|Drug|Azacitidine (BAML-16-001-S18)|75 mg/m2, IV or SC, on days 1-7 or days 1-5 and 8 and 9 or days 1-2 and 5-9 (based on institutional guidelines) of each 28-day cycle until time of progression, unacceptable toxicity, death, or 57 total cycles of treatment
15983118|NCT03013985|Drug|Glargine U300|Glargine U300 is a new generation long-acting insulin.
15983119|NCT03013985|Drug|Glargine U100|Glargine U100 is a long-acting insulin.
15983120|NCT03013985|Drug|Glulisine Insulin|Glulisine is a mealtime insulin taken either 15 minutes before or 20 minutes after a meal.
15983121|NCT03013959|Drug|Pranoprofen|it is an NSAIDs.As is reported, NSAIDs(pranoprofen) eye drops can suppress herpes simplex virus（HSV-1） reactivation and reduce inflammatory reaction in vitro and in vivo. In Clinical, there is no risk of corneal tissue melting, glaucoma, cataract by topical application of NSAIDs.
15983122|NCT03013946|Behavioral|Concomitant coaching|"The corner stones of the pro-active coaching are as follows:
~Patient education:
~Information on nature and severity of treatment emergent AEs
~information about remedies for TEAEs
~propagation and explanation of tests and treatment decisions
~Patient instruction on self-care and preventive measures
~Preemptive AE treatment strategies
~Supervision of reported ADR severity, ADR mitigation strategies according to recommendations of the PREPARE protocol and cancer treatment modification by treating physician in close collaboration with the coach"
15983123|NCT03013933|Drug|Brentuximab Vedotin|Given IV
15983124|NCT03013933|Drug|Cyclosporine|Given PO
15983125|NCT03013933|Other|Pharmacokinetic Study|Correlative studies
15983126|NCT03013933|Drug|Verapamil|Given PO
15983127|NCT03013933|Drug|Verapamil Hydrochloride|Given PO
15983128|NCT03013907|Behavioral|UPLIFT|Session 1: Introduction to UPLIFT/Noticing Thoughts Session 2: Checking and Changing Thoughts Session 3: Coping & Relaxing Session 4: Attention & Mindfulness Session 5: The Present as a Calm Place Session 6: Thoughts as Changeable, Thoughts as Not Fixed Session 7: Focus on Pleasure & the Importance of Reinforcement Session 8: Preventing Lapses and Giving Thanks
15983129|NCT03013907|Behavioral|Usual care|Subjects randomized to UC will be advised to seek help from their primary care physician (PCP) or other sources as they normally would if they encountered symptomatic deterioration or other difficulties over the course of the study
15983130|NCT03013881|Biological|UB-921|150 mg/vial
15983131|NCT03013881|Biological|Herceptin|440 mg/vial
15983178|NCT03013465|Other|Control Diet|Participants will receive a controlled diet with 0 g/d of broccoli. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet.
15983133|NCT03013855|Device|FIT-DRE|Study subjects will have a digital rectal exam completed by their primary care providers during the physical exam portion of a routine clinic visit. The stool collected on the examiner's finger will be applied to the FIT applicator in the standard kit, which will then be sent to the lab for processing.
15983134|NCT03013842|Device|Raydiant Oximetry Sensor System|Administration of Fetal Oximetry Probe on 36 weeks or greater pregnant women
15983135|NCT03013829|Behavioral|KPD Educational Video|LKDs and recipients assigned to the video-based KPD education group will receive the same living donation and KPD educational materials as those in the UC group. Also, as in the UC group, they will be encouraged by the site coordinator to review the educational materials. In addition, following randomization to this group, participants will be sent an email encouraging them to watch an embedded KPD education video. This video will be professionally designed and will highlight the operational features of KPD and address the specific barriers highlighted in our formative research. The primary goal of these sessions is to increase living donation and KPD knowledge of risks and benefits and to reduce specific concerns that are based on inaccurate information. The intent is not to persuade LKDs or recipients to pursue living donation or KPD, but to ensure that they have sufficient information to make an informed choice that is consistent with their own values and preferences.
15983136|NCT03013816|Behavioral|Organ Donation Education: Testimonial Messaging|The testimonial messaging video intervention will be shown
15983137|NCT03013816|Behavioral|Organ Donation Education: Informational Messaging|The informational messaging video intervention will be shown
15983138|NCT03013816|Behavioral|Organ Donation Education: Blended Messaging|The blended messaging video intervention will be shown
15983139|NCT03013803|Dietary Supplement|Nutricomp Drink Plus Fibre|
15983140|NCT03013790|Drug|Melatonin|Patients will receive Melatonin at 2 different doses or a placebo
15983141|NCT03013777|Behavioral|8-week CBT Program|
15983142|NCT03013764|Behavioral|normal protein diet|subjects will undergo 10 days of low physical activity while consuming a normal protein diet
15983143|NCT03013764|Behavioral|high protein intake|subjects will undergo 10 days of low physical activity while consuming a high protein diet
15983144|NCT03013751|Drug|Udenafil|Active drug
15983145|NCT03013738|Behavioral|Growing Pro-Social Program|GPS is a structured cognitive-behavioral group program aimed to reduce the prominence of early maladaptive schemas
15983146|NCT03013738|Other|Treatment As Usual|TAU in Portuguese prisons is primarily aimed to increase educational and professional qualifications
15983147|NCT03013725|Other|No intervention|No intervention
15983148|NCT03013712|Biological|CAR-T cell immunotherapy|This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at EpCAM antigen.
15983149|NCT03013699|Behavioral|Cruciferous and Dark Leafy Green Intervention|Participants receive individual dietary counseling from a Registered Dietitian who will focus on increasing intake of cruciferous and green leafy vegetables while addressing any disease- and treatment-related eating difficulties experienced by the participant.
15983150|NCT03013699|Behavioral|Usual Dietary Care|Participants receive standard educational materials that focus on healthy eating for cancer survivors and the opportunity to briefly discuss nutrition-related concerns with the Registered Dietitian weekly.
15983151|NCT03013686|Procedure|Interval appendectomy|Laparoscopic appendectomy
15983152|NCT03013686|Procedure|Follow-up with MRI|Abdominal MRI
15983153|NCT03013673|Other|No intervention|No intervention
15983154|NCT03013660|Other|Limited Financial Support|Subjects randomized to this arm will be contacted to be informed that they are eligible to receive a weekly financial transfer to help them spend more time with their baby at the NICU. The intervention participants will be eligible to receive this transfer every 7 days, starting on the day of enrollment.
15983155|NCT03013647|Drug|Methyl Aminolevulinate|"Patients will be treated with Daylight Photodynamic therapy, following these steps:
~mild curettage of the AK lesions
~application of a chemical sunscreen SPF 30
~application of methyl aminolevulinate cream (Metvix R, Galderma Laboratories)
~exposition to daylight, for 120 minutes
~cleaning of the face"
15983156|NCT03013634|Drug|Dexmedetomidine|Dexmedetomidine infusion:loading 0.5ug/kg for 10min, then 0.5 ug/kg/h until the end of operation.
15983157|NCT03013634|Drug|Normal saline|Equal volume normal saline substitute for dexmedetomidine
15983158|NCT03013608|Procedure|Simple relocation of the nail plate in nailbed injuries in paediatric population|Repositioning the nail bed without sutures
15983159|NCT03013595|Behavioral|TRAM feedback|
15983160|NCT03013582|Biological|Amnion Tendon Wrapping|Tendon is wrapped with the allograft
15983161|NCT03013582|Procedure|Surgical Tenolysis|Surgical release of peritendinous scarred tissue
15983162|NCT03013556|Drug|Group A, TDF|TDF for 96 weeks
15983163|NCT03013556|Drug|Group B:TDF then TDF and Peginterferon alfa-2a|Subjects will be treated by TDF in the first 48 weeks, then will be treated by the combination of TDF and Peginterferon alfa-2a for another 48 weeks
15983164|NCT03013556|Drug|Group C:TDF and Peginterferon alfa-2a then TDF|Subjects will be treated by the combination of TDF and Peginterferon alfa-2a for the first 48 weeks, then will be treated by TDF for another 48 weeks.
15983165|NCT03013543|Drug|Setmelanotide|RM-493 once daily subcutaneous injection
15983166|NCT03013530|Procedure|Decision making for ICU patients' care|Study of factors involved in the decision-making for ICU patients' care. Effect of advance directives (AD).
15983167|NCT03013517|Drug|Viaskin Peanut 250µg|DBV712 250 µg, once daily
15983168|NCT03013504|Drug|HD201|Loading dose of 8mg/kg in Cycle 1 and 6mg/kg in subsequent cycles.
15983169|NCT03013504|Drug|Herceptin|Loading dose of 8mg/kg in Cycle 1 and 6mg/kg in subsequent cycles.
15983170|NCT03013504|Drug|Docetaxel|75mg/m2 via i.v. infusion during cycles 1 to 4.
15983171|NCT03013504|Drug|Epirubicin|75 mg/m2 via i.v. infusion during cycles 5-8.
15983172|NCT03013504|Drug|Cyclophosphamide|500 mg/m2 via i.v. infusion during cycles 5-8.
15983173|NCT03013491|Drug|CX-072|
15983174|NCT03013491|Drug|ipilimumab|
15983175|NCT03013491|Drug|vemurafenib|
15983176|NCT03013478|Behavioral|Standard Treatment As Usual (TAU)|Treatment normally offered at this primary care clinic
15983177|NCT03013478|Behavioral|CBT4CBT program|
15983604|NCT03010488|Behavioral|Morning Light Therapy|10,000 Lux light for 30 minutes through a light box each morning at patient's desired wake up time.
15983179|NCT03013465|Other|Base Diet with Broccoli|Participants will receive a controlled diet with 100 g of broccoli at both breakfast and dinner daily. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet.
15983180|NCT03013452|Device|oPEP|Daily chest clearance (chest physiotherapy) using an oPEP (Aerobika) device.
15983181|NCT03013452|Behavioral|Autogenic drainage|Daily chest clearance (chest physiotherapy) by Autogenic Drainage method.
15983182|NCT03013439|Drug|Iron Isomaltoside|The trial is a dose escalating trial.
15983183|NCT03013426|Drug|NVX-508|Administration of NVX-508 emulsion intravenously
15983184|NCT03013413|Procedure|Shear Wave Elastography|Undergo ultrasound-based elastography imaging using the Aixplorer system
15983185|NCT03013413|Procedure|Ultrasound Elasticity Imaging|Undergo ultrasound-based elastography imaging using the Aixplorer system
15983186|NCT03013413|Procedure|Ultrasound-Guided Prostate Biopsy|Undergo standard of care ultrasound-guided prostate biopsy
15983187|NCT03013400|Drug|Ebselen|Ebselen is an opaque capsule containing 200 mg of ebselen is a selenium-based GPx mimic and IMPase inhibitor.
15983188|NCT03013400|Drug|Placebo oral capsule|Placebo is identical in appearance to the ebselen capsules
15983189|NCT03013387|Radiation|90Y-DOTA-3-tyr-Octreotide|90Y-DOTATOC is a radiopharmaceutical that will be used l as a treatment for both children and adults with neuroendocrine and other somatostatin receptor positive tumors.
15983190|NCT03013387|Procedure|Positron Emission Tomography (PET) whole body scan|68Ga-DOTATOC is a radiopharmaceutical used in PET scans to identify tumors as it can adhere to Somatostatin Receptors.
15983191|NCT03013387|Drug|Amino Acids|This is a solution of amino acids that will decrease the amount of 90Y-DOTATOC that recirculates through the body after injection, therefore decreasing radiation dose to the kidneys.
15983192|NCT03013361|Drug|Bupivacaine|Post operative pain control
15983193|NCT03013361|Drug|Ropivacaine|Post operative pain control
15983194|NCT03013361|Other|Normal Saline|Acts as comparator
15983195|NCT03013348|Device|Brain Sentinel's sEMG Post-processing algorithm|Brain Sentinel has developed a post processing method that identifies sEMG signals (recorded from the biceps brachii or as muscle artifact in electroencephalography [EEG] recordings) that are pathognomonic for PNES activity.
15983196|NCT03013335|Drug|Nivolumab|"The dose and schedule of nivolumab in this study will be 3 mg/kg every 2 weeks. Infusion of nivolumab will be performed in 30 minutes (± 5 minutes).
~Nivolumab will be administered every 2 weeks until death, disease progression, unacceptable toxicity or withdrawal of the informed consent"
15983197|NCT03013322|Drug|Physostigmine|
15983198|NCT03013322|Drug|Isotonic Saline|
15983199|NCT03013309|Behavioral|Family Check-Up 4 Health|A parent-training intervention to improve child health and prevent/manage obesity
15983200|NCT03013309|Other|Treatment as usual|Treatment as usual
15983201|NCT03013296|Other|GIP-A|GIP-A
15983202|NCT03013296|Other|Placebo|Placebo
15983203|NCT03013296|Other|GLP-1 receptor antagonist Exendin[9-39]|Exendin[9-39]
15983204|NCT03013296|Other|GIP-A + Exendin[9-39]|GIP-A + Exendin[9-39]
15983205|NCT03013283|Other|self questionnaire|"Interface side effects and degree of satisfaction of the patients
~Technician evaluation and device measures."
15983206|NCT03013270|Other|Aerobic-Resistance-Inspiratory|Patients will be submitted to a 12 week, 3 times/week, continuous aerobic (e.g. bike) training programme at an intensity of 60-80% max HR (or peakVO2) for 30 min combined with resistance training at an intensity of 50% of 1 Repetition Maximum (1RM) for quads training and upper limb exercises (elbow flex/shoulder flex/abd) using dumbbells (1-2 kg) (12-15 reps/3sets) for 10 min, combined also with inspiratory muscle training with a flow-resistive loading system at an intensity of 60% of maximal inspiratory pressure/sustained maximal inspiratory pressure (PImax/SPImax) for 20 min (Aerobic (30min) + Resistance (10min) + Inspiratory (20min) = 60 min)
15983207|NCT03013270|Other|Aerobic-Resistance|"Patients will be submitted to a 12 week, 3 times/week, continuous aerobic (e.g. bike) training programme at an intensity of 60-80% max HR (or peakVO2) for 30 min combined with resistance training at an intensity of 50% of 1RM for quads training, pectoralis m, serratus anterior m, and latissimus dorsi m and upper limb exercises (elbow flex/shoulder flex/abd) using dumbbells (1-2 kg) (12-15 reps/3sets).
~(Aerobic (30min) + Resistance (30min) = 60 min)"
15983208|NCT03013270|Other|Aerobic-Inspiratory|Patients will be submitted to a 12 week, 3 times/week, continuous aerobic (e.g. bike) training programme at an intensity of 60-80% max HR (or peakVO2) for 30 min combined with inspiratory muscle training with a flow-resistive loading system at an intensity of 60% of maximal inspiratory pressure/sustained maximal inspiratory pressure (PImax/SPImax) for 30min (Aerobic (30min) + Inspiratory (30min) = 60 min)
15983209|NCT03013270|Other|Aerobic Training|Patients will be submitted to a 12 week, 3 times/week continuous aerobic (e.g. bike) training programme at an intensity of 60-80% max HR (or peakVO2) for 30 min combined with callisthenics progressing to treadmill or bike (at the same intensity) for 30 min (Aerobic training = 60 min)
15983210|NCT03013257|Device|Echopulse|Replacing HIFU for the Graves' disease patients who traditionally have RAI to remission
15983211|NCT03013244|Behavioral|The Body Project: More Than Muscles|Participants complete a variety of activities designed to counter internalization of the lean, muscular body ideal for men.
15983212|NCT03013231|Behavioral|Brief Resilience Scale|6 months post-op, patients will complete the BRS survey as a method of evaluating resilience.
15983213|NCT03013218|Drug|Evorpacept (ALX148)|Evorpacept (ALX148)
15983214|NCT03013218|Drug|Pembrolizumab|Keytruda
15983215|NCT03013218|Drug|Trastuzumab|Herceptin
15983216|NCT03013218|Drug|Rituximab|Rituxan
15983217|NCT03013218|Drug|Ramucirumab + Paclitaxel|Standard of care chemotherapy
15983218|NCT03013218|Drug|5-FU + Cisplatin|Standard of care chemotherapy
15983219|NCT03013205|Procedure|Intraarticular triamcinolone injection|triamcinolone 10mg/mL
15983220|NCT03013205|Procedure|Intraarticular Xylocaine injection|Xylocaine 1% 4ml
15983221|NCT03013205|Procedure|Coracohumeral ligament triamcinolone injection|triamcinolone 10mg/mL
15983222|NCT03013205|Procedure|Physiotherapy|
15983223|NCT03013192|Other|Text message reminder|Patients will receive automated text message reminders regarding their physical therapy
15983748|NCT03009461|Drug|Sorafenib|400 mg of sorafenib (consisting of two 200-mg tablets) twice daily.
15983224|NCT03013166|Other|Corticosteroid medication|Patients will be grouped into Cohort 1 (IR hydrocortisone), cohort 2 (IR prednisolone), cohort 3 (MR hydrocortisone), or cohort 4 (IR to MR hydrocortisone) depending on which oral corticosteroid medications were received during the observation period.
15983225|NCT03013153|Procedure|Low ligation with apical lymph node dissection|Low ligation with apical lymph node dissection (LAND). Left colic artery (LCA) is identified according to the CT 3D-reconstruction, tie the sigmoid artery and superior rectal artery, preserved LCA while low ligation of the inferior mesenteric artery is performed. Lymphadenectomy to the apical lymph nodes (No.253)is performed around the IMA until 2 cm from the aorta.
15983226|NCT03013153|Procedure|High ligation|High ligation (HL) Open the peritoneum proceeds cephalad towards the duodenojejunal angle of Treitz, and the mesenteric root is incised 1 cm below the inferior margin of the pancreas. The aortomesenteric window is opened wide and the inferior mesenteric vessels are exposed. The IMA is ligated and divided at 2 cm from its origin. The inferior mesenteric vein (IMV) is divided and ligated below the pancreatic margin.
15983227|NCT03013140|Drug|Fluid therapy|"Goal directed Fluid therapy: Within 30 minutes before spinal anaesthesia, repeat Ringer's Injection 3ml/kg within 3 minutes with 1-min gap until ΔSV<5%"
15983228|NCT03013140|Procedure|Spinal anaesthesia|Inject marcaine and fentanyl to CSF for anaesthesia
15983229|NCT03013127|Drug|Pembrolizumab|Pembrolizumab is a humanized antibody used in cancer immunotherapy.
15983230|NCT03013114|Drug|Bortezomib|Bortezomib was given by intravenous bolus injection at a dose of 1.3 mg/m2 on days 1, 4, 8 and 11, repeated every 21 days. It will be given four cycles.
15983231|NCT03013101|Biological|humanized anti-PD-1 monoclonal antibody toripalimab|humanized anti-PD-1 monoclonal antibody (JS001) is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically.
15983232|NCT03013088|Device|CTO Crossing|With confirmation that the target vessel is completely occluded by the target CTO lesion, the operator shall initially attempt crossing the proximal end of the target CTO lesion by advancing ShockWireTM device ≥ 1cm. The SoundBite Crossing device can be activated as needed to perform the procedure and may be used for the entire length of the lesion(s).
15983233|NCT03013075|Procedure|Spinal anesthesia with Bupivacaine heavy and Morphine|Spinal anesthesia with Bupivacaine heavy 40 mg and Morphine 250 micro grams will be given to patient in addition to the routine general anesthesia before the start of surgery
15983234|NCT03013075|Drug|Bupivacaine heavy and Morphine|
15983235|NCT03013075|Drug|General Anesthetics|
15983236|NCT03013049|Procedure|Non cultured epidermal cell suspension|Non cultured epidermal cell suspension Split thickness skin specimen will be transferred under aseptic conditions to a container with normal salineand transferred to laboratory. There, the skin graft will be transferred to Trypsin-EDTA solution (0.25% trypsin and 0.02% EDTA) in a Petri dish and incubated overnight at 4°C in 5% CO2 to separate the epidermis from the dermis.Afterwards, the Trypsin-EDTA solution will be removed and PBS will be added and pipetted well so as to separate the cells from the tissue.The suspension will be centrifuged at 1000 rpm for 5 minutes.The supernatant will then be discarded and Phosphate buffer saline is added to make suspension of non-cultured epidermal cells.
15983237|NCT03013049|Procedure|Non cultured dermal cell suspension|Non-cultured Dermal Cell Suspension Skin punch will be collected in phosphate buffer saline (PBS) with antibiotics (penicillin and streptomycin). The epidermis will be cut off from dermis carefully using a surgical blade (Epidermal part will be used for the epidermal cell suspension). Dermis will be then cut into small pieces and incubated in collagenase (1mg/ml) overnight at room temperature. Next day content will be diluted with PBS and centrifuged at 1000rpm for 5 minutes. Pellet will be washed three times with PBS to remove collagenase activity. Phosphate buffer saline is added to make suspension of non-cultured dermal cells and will be used for the autologous transplantation.
15983238|NCT03013036|Device|Ultrasonography|
15983239|NCT03013036|Drug|Sevoflurane|
15983240|NCT03013036|Drug|intravenous midazolam|
15983241|NCT03013036|Drug|Propofol|
15983242|NCT03013036|Drug|fentanyl and rocuronium|
15983243|NCT03013023|Behavioral|BS|NNS, FT, positional support, and oral sucrose feeding
15983244|NCT03013023|Behavioral|Routine care|Routine NICU care
15983245|NCT03013023|Behavioral|PITP|Parents will learn to regulate infant responses while implementing caregiving activities.
15983246|NCT03013023|Behavioral|BS+PITP|Parents will learn to regulate infant responses while implementing caregiving activities. Supportive interventions, i.e., NNS, FT, positional support, and oral sucrose feeding, will be provided while infants are undergoing painful procedures.
15983247|NCT03013010|Drug|Tegafur-Gimeracil-Oteracil Potassium|The dose of S-1 is according to body-surface area (BSA): patients with a BSA of less than 1.25 m2 received 80 mg daily; those with a BSA of 1.25 m2 or more but less than 1.5 m2 received 100 mg daily; and those with a BSA of 1.5 m2 or more received 120 mg daily. oxaliplatin 130mg/m2, intravenously, on day 1.
15983248|NCT03013010|Radiation|Chemoradiotherapy|"Chemotherapy: S-1 40-60mg/m2 orally, oral tablet twice daily, days 1-5 of each week of radiotherapy.
~Radiotherapy: 45 Gy of radiation in 25 fractions, five days per week for five weeks."
15983249|NCT03013010|Procedure|Gastric resection|A standard D2 gastrectomy was recommended. The type of gastrectomy performed depended on the location and extent of the primary lesion. For middle third tumors, the gastric margin was recommended to be more than 5 cm, and a total gastrectomy was performed. For lower third tumors, a 2 cm duodenal margin was recommended and a subtotal or total gastrectomy was considered. For upper third tumors, a 3 cm esophageal margin was recommended and a total gastrectomy or esophagogastrectomy was performed. Billroth I or Roux-en-y gastrojejunostomy was performed for distal gastrectomy patients, Roux-en-y esophagojejunostomy was performed for total gastrectomy patients.
15983250|NCT03013010|Drug|Oxaliplatin|The dose of oxaliplatin is according to body-surface area (BSA): 130mg/m2, intravenously, on day 1.
15983251|NCT03012997|Other|Fraction of inspired oxygen 40%|
15983252|NCT03012997|Other|Fraction of inspired oxygen 100%|
15983358|NCT03012243|Procedure|Gallbladder aspiration|Percutaneous ultrasound-guided aspiration of bile from the gallbladder. This is performed without leaving a drain in the gallbladder. The aspiration is performed with the intention to relief the pressure in the gallbladder, without drain.
15983749|NCT03009448|Other|Interview|Each subject will be interviewed using a semi constructed interview.
15983253|NCT03012984|Drug|Dexmedetomidine supplemented morphine analgesia|Patients in this group will receive patient-controlled intravenous analgesia for 3 days after surgery. The formula is a mixture of dexmedetomidine (1.25 ug/ml) and morphine (0.5 mg/ml), diluted with normal saline to 160 ml. 5-HT3 receptor antagonist is added when necessary. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with a bolus dose of 2 ml each time and a lockout time from 6 to 8 minutes according to patients' condition.
15983254|NCT03012984|Drug|Morphine analgesia|Patients in this group will receive patient-controlled intravenous analgesia for 3 days after surgery. The formula is morphine (0.5 mg/ml) diluted with normal saline to 160 ml. 5-HT3 receptor antagonist is added when necessary. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with a bolus dose of 2 ml each time and a lockout time from 6 to 8 minutes according to patients' condition.
15983255|NCT03012971|Drug|Dexmedetomidine supplemented morphine analgesia|Patients in this group receive patient-controlled intravenous analgesia for 3 days after surgery. The formula is a mixture of dexmedetomidine (1.25 ug/ml) and morphine (0.5 mg/ml), diluted with normal saline to 160 ml. 5-HT3 receptor antagonist is added when necessary. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with a bolus dose of 2 ml at each time and a lockout time from 6 to 8 minutes.
15983256|NCT03012971|Drug|Morphine analgesia|Patients in this group receive patient-controlled intravenous analgesia for 3 days after surgery. The formula is morphine (0.5 mg/ml), diluted with normal saline to 160 ml. 5-HT3 receptor antagonist is added when necessary. The analgesic pump is set to administer a background infusion at a rate of 1 ml/h, with a bolus dose of 2 ml at each time and a lockout time from 6 to 8 minutes.
15983257|NCT03012958|Other|Lung clearance index (LCI)|LCI is determined by the number of lung volume turnovers necessary to clear the lungs of an inert tracer gas such as nitrogen that is inhaled at the beginning of the test. The LCI is calculated by determining the cumulative expired volume (CEV) and then dividing the CEV by the functional residual capacity. Values of less than7.0 indicate normal values while an LCI greater than 7.0 is associated with heterogeneity in ventilation and distal airway abnormalities. The ability to detect peripheral airway disease may make LCI a better modality for detecting distal airways abnormalities seen on lung histopathology but often missed on traditional pulmonary function testing.
15983258|NCT03012945|Drug|Combined epidural-general anesthesia|Combined epidural-general anesthesia and postoperative epidural analgesia. General anesthesia is performed as that in the general anesthesia group. Epidural anesthesia is performed with ropivacaine. Epidural analgesia is performed with a mixture of ropivacaine and sufentanil.
15983259|NCT03012945|Drug|General anesthesia|General anesthesia and postoperative intravenous analgesia. General anesthesia is performed with propofol induction and propofol and/or sevoflurane maintenance. Intravenous analgesia is performed with morphine.
15983260|NCT03012932|Behavioral|HPV self-sampling|All participants will receive HPV self-sampling intervention. HPV self-sampling is a cervical cancer screening that can be done in private, using a device that is similar to a tampon. This intervention tests for high-risk HPV, the primary cause of cervical cancer. Each participant will complete the intervention one time only.
15983261|NCT03012919|Other|active decision support system|The active decision support system in this study is a goal directed therapy (GDT) protocol where threshold hemodynamic values are defined when to give fluid, vasopressors and inotropes. Hemodynamic values are measured with the LiDCOrapid device, which uses pulse contour analysis to continuously monitor cardiac output and respiratory variations in stroke volume (SVV).
15983262|NCT03012906|Other|the prevalence of ischemic events|
15983263|NCT03012893|Device|Ultrasound sagittal scan|Convex transducer will be placed at patient's neck using paramedian sagittal scan and pointing toward the chest apex aiming to identify the first rib. Then move the transducer medially to identify the transverse process along with identify C7 transverse process will appear on the image as a hyperechoic shadow without continue to the rib laterally. Place the C7 spinous process on the midpoint of the probe and the spinous process correspondence to the midline will be marked as C7.
15983264|NCT03012893|Device|Ultrasound transverse scan|Linear transducer will be placed at patient's lateral neck using transverse scan. The unique characteristic of sonography of transvers process of C6 and C7 will be used to identify the transverse process of C6 and C7. C6 transverse process has a very prominence anterior tubercle (known as Chassaignac tubercle). While anterior tubercle of C7 is absent. After identifying the C7 transverse process, simultaneously the color Doppler mode will be activated to identify the vertebral artery for double confirmation.
15983265|NCT03012893|Procedure|Fluoroscopic technique|C7 spinous process will be identified by counting down from C1 vertebral body and spinous process.
15983266|NCT03012880|Biological|Daratumumab|Given IV
15983267|NCT03012880|Drug|Dexamethasone|Given PO
15983268|NCT03012880|Drug|Ixazomib Citrate|Given PO
15983269|NCT03012880|Other|Laboratory Biomarker Analysis|Correlative studies
15983270|NCT03012880|Drug|Lenalidomide|Given PO
15983271|NCT03012880|Other|Questionnaire Administration|Ancillary studies
15983272|NCT03012867|Other|Diben, Fresenius Kabi|Patients receive Diben continously for 7 days
15983273|NCT03012867|Other|Fresubin original fibre, Fresenius Kabi|Patients receive Fresubin original fibre continously for 7 days
15983274|NCT03012854|Procedure|short-myotomy|"Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 8-10 cm proximal to the gastroesophageal junction (GEJ).
~Submucosal tunnelling. A long submucosal tunnel is created to 3 cm distal to the GEJ.
~Endoscopic myotomy is carried out in a proximal to distal direction to a total length less than 7 cm. The expected end point of myotomy is 2 cm distal to the GEJ.
~Myotomy of inner circular muscle bundles and outer longitudinal muscle layer is done.
~Closure of mucosal entry: the mucosal incision is closed using hemostatic clips."
15983275|NCT03012854|Procedure|long-myotomy|"Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 8-10 cm proximal to the gastroesophageal junction (GEJ).
~Submucosal tunnelling. A long submucosal tunnel is created to 3 cm distal to the GEJ.
~Endoscopic myotomy is carried out in a proximal to distal direction to a total length more than 7 cm. The expected end point of myotomy is 2 cm distal to the GEJ.
~Myotomy of inner circular muscle bundles and outer longitudinal muscle layer is done.
~Closure of mucosal entry: the mucosal incision is closed using hemostatic clips."
15983482|NCT03011528|Drug|Maintenance|"* 1st year : VC
~Vinblastine, IV, 3mg/m², once a week (except during radiotherapy: 1mg/m², 3 times a week)
~Cyclophosphamide, PO, 25mg/m² continuously"
15983276|NCT03012854|Procedure|full-thickness myotomy|"Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 8-10 cm proximal to the gastroesophageal junction (GEJ).
~Submucosal tunnelling. A long submucosal tunnel is created to 3 cm distal to the GEJ.
~Endoscopic myotomy is carried out in a proximal to distal direction to a total length more than 7 cm. The expected end point of myotomy is 2 cm distal to the GEJ.
~Myotomy of inner circular muscle bundles and outer longitudinal muscle layer is done.
~Closure of mucosal entry: the mucosal incision is closed using hemostatic clips."
15983277|NCT03012854|Procedure|circular myotomy|"Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 8-10 cm proximal to the gastroesophageal junction (GEJ).
~Submucosal tunnelling. A long submucosal tunnel is created to 3 cm distal to the GEJ.
~Endoscopic myotomy is carried out in a proximal to distal direction to a total length more than 7 cm. The expected end point of myotomy is 2 cm distal to the GEJ.
~Myotomy of inner circular muscle bundles is done, leaving the outer longitudinal muscle layer intact.
~Closure of mucosal entry: the mucosal incision is closed using hemostatic clips."
15983278|NCT03012841|Device|Arctic Front Advance Cardiac CryoAblation Catheter|Cryoablation
15983279|NCT03012828|Drug|Moxidectin|Moxidectin is a broad spectrum macrocyclic lactone endectocide
15983280|NCT03012828|Other|Placebo|
15983281|NCT03012815|Drug|Gabapentin|Gabapentin administered as a taper
15983282|NCT03012815|Drug|Benzodiazepines|Benzodiazepines administered using a symptoms triggered protocol
15983283|NCT03012815|Drug|Divalproex Sodium|Given in addition to gabapentin in high risk patients (i.e. seizures, TBI history, DT history)
15983284|NCT03012802|Procedure|Colorectal Surgery|Postoperative Audit
15983285|NCT03012789|Procedure|Surgery|Surgical excision
15983286|NCT03012776|Device|Total Posterior Spine System (TOPS)|Placement of TOPS System to provide posterior stabilization following decompression to treat lumbar spinal stenosis and spondylolisthesis
15983287|NCT03012776|Procedure|Transforaminal Lumbar Interbody Fusion (TLIF)|Fusion with placement of interbody cage and posterolateral instrumentation
15983288|NCT03012763|Drug|Paracetamol|Oral administration of 250 mg paracetamol
15983289|NCT03012763|Drug|Sulfasalazine|Oral administration of 50 mg sulfasalazine
15983290|NCT03012763|Drug|Fexofenadine|Oral administration of 120 mg fexofenadine
15983291|NCT03012763|Drug|Valsartan|Oral administration of 40 mg valsartan
15983292|NCT03012763|Device|non-caloric water|Oral administration of 240 ml non-caloric water
15983293|NCT03012763|Device|caloric drink|Oral administration of 240 ml caloric drink
15983294|NCT03012763|Device|grapefruit juice|Oral administration of 240 ml grapefruit juice
15983295|NCT03012750|Drug|Indocyanine Green|Perioperative application of 0.1 mg ICG per kg Body weight
15983296|NCT03012737|Device|Trilogy 100 ® (Philips Respironics)|Trilogy 100 ® (Philips Respironics) on MPV mode.
15983297|NCT03012724|Device|H7-Coil|Deep transcranial magnetic stimulation for the treatment of major dispersion disorder with the H7-Coil
15983298|NCT03012724|Device|H1-Coil|Deep transcranial magnetic stimulation for the treatment of major depression disorder with the FDA cleared H1-Coil
15983299|NCT03012711|Other|Neuromuscular exercise training|
15983300|NCT03012698|Device|Ocular Repetitive Magnetic Stimulation (RMS) treatment|"First stage: Patients will be asked to undergo a one-time treatment with Epitech Corneal Magnetic Stimulation Device on one eye. The worst eye will be treated; if both eyes are equal, the right eye will be treated.
~Second stage: will be treated on both eyes, applying treatment to both eyes sequentially during the same visit."
15983301|NCT03012672|Drug|Cladribine|Given IV
15983302|NCT03012672|Drug|Cytarabine|Given IV
15983303|NCT03012672|Biological|Granulocyte Colony-Stimulating Factor|Given SC
15983304|NCT03012672|Drug|Mitoxantrone Hydrochloride|Given IV
15983305|NCT03012672|Other|Quality-of-Life Assessment|Ancillary studies
15983306|NCT03012672|Other|Questionnaire Administration|Ancillary studies
15983307|NCT03012659|Behavioral|Contraceptive Counseling Training|"Intervention sites will receive:
~In person training: All staff at an intervention health center will participate in a one-day counseling training.
~On-site shadowing: Trainers will shadow staff in-clinic the day following the training to observe the counseling implementation and provide additional coaching and support.
~Technical assistance: A Planned Parenthood clinic operations expert will provide follow-up technical assistance."
15983308|NCT03012646|Drug|Inhaled Treprostinil|Inhaled treprostinil (6 mcg/breath) administered four times daily
15983309|NCT03012633|Device|Lysis timer|Lysis Timer compared with standard laboratory test to diagnose hyperfibrinolysis during liver transplantation.
15983310|NCT03012620|Drug|Pembrolizumab|Treatment
15983311|NCT03012607|Drug|Truvada|Participants will be randomized into 1 of 3 groups (10 participants/group) to receive a controlled number of doses of tenofovir disoproxil fumarate (TDF, 300mg) in a combination pill with emtricitabine (FTC, 200mg) (Truvada®)
15983312|NCT03012594|Drug|Lanreotide|Dosage: 120mg Dosage form: subcutaneous injection, pre-filled syringe Dosage frequency: 3 injections over 12 weeks, each dose administered 4 weeks apart
15983313|NCT03012581|Drug|Nivolumab|Treatment
15983314|NCT03012568|Device|SJM Implantable cardiac devices|SJM implantable devices undergoing MRI scan
15983315|NCT03012542|Dietary Supplement|Diet 1|Diet controlled in amount and source of carbohydrates or fiber containing foods.
15983316|NCT03012542|Dietary Supplement|Diet 2|Diet controlled in amount and source of carbohydrates or fiber containing foods.
15983317|NCT03012529|Drug|Rifampin|Subjects who are randomly assigned to adjunctive rifampin will receive a 600 mg oral daily dose targeted for a six-week period. If a subject experiences gastrointestinal intolerance on once daily dosing, the study drug may be administered as rifampin 300 mg twice a day.
15983318|NCT03012529|Drug|Riboflavin Placebo|A placebo capsule will be administered daily to match frequency and duration of rifampin interventional drug. For the purpose of mimicking urine discoloration when taking rifampin, riboflavin will be added to the placebo to produce a urine discoloration effect.
15983319|NCT03012516|Behavioral|PAP-treatment by physiotherapist|
15983320|NCT03012516|Behavioral|Ordinary PAP-treatment at the health care center|
15983598|NCT03010553|Procedure|Detection and resection of sentinel lymph node|
15983321|NCT03012503|Drug|BioFreeze|The estimated surface area of the average adult's neck is 350cm and the standard dose of Biofreeze® to achieve a clinically significant effect has been sited to be 1ml/200cm2 of skin surface area. Using this data approximately 1.75 ml of the assigned gel was applied to each participant's neck (posterior, anterior, left lateral and right lateral) by the same member of the research team, 5 minutes prior to an independent practitioner performing cervical manipulation on the participant.
15983322|NCT03012503|Drug|Placebos|control gel with a similar packaging, texture, and scent as Brand X but without the active ingredient of menthol
15983323|NCT03012490|Other|CRT-P or CRT-D standard remote monitoring|standard for the control group: remote monitoring of ventricular rhythm disorders and technical parameters of the implanted system
15983324|NCT03012490|Other|CRT-P or CRT-D full remote monitoring|Full follow-up for the Active group: remote monitoring of ventricular rhythm disorders and technical parameters of the implanted system + supraventricular rhythm disorders, parameters related to heart failure, including symptoms and clinical signs of the patient
15983325|NCT03012490|Other|Symptoms and signs remote monitoring|symptoms and clinical signs of the patient
15983326|NCT03012477|Drug|Cisplatin|Cisplatin will be given on the first day of every cycle. Each cycle is 21 days long.
15983327|NCT03012477|Drug|AZD1775|The first dose of AZD1775 will be administered in clinic on the first day of the second cycle. Subsequent doses will be taken approximately 12 hours apart for a total of five doses. Each cycle is 21 days long.
15983328|NCT03012464|Other|Pathologic and functional assessment|Random biopsies will be taken from the pelvic floor muscles, external anal sphincter, and the lateral supportive ligaments of the rectum during surgical treatment of rectal prolapse whether via the abdominal or perineal approach. Tissue samples will be subjected to immunohistochemistry to calculate the ratio between collagen type I and type III, and to reveal any myopathic or degenerative changes
15983329|NCT03012451|Behavioral|Advancing Adolescents|"The Advancing Adolescents programme is a structured 8-week psychosocial intervention for adolescents in humanitarian crises, based on profound stress attunement processes. It features three elements that are widely viewed as important to support youth adjustment in contexts of complex emergencies: (i) safety: establishment of a 'safe space' within the community as a base for activities and site of protection; (ii) support: facilitation of social support and self-expression; and (iii) structured activities: access to scheduled group activities."
15983330|NCT03012438|Device|NIRF imaging in thyroid surgery|a fluorescence imaging system and 7.5 mg of ICG will be used to visualize the parathyroids glands.
15983331|NCT03012425|Behavioral|Cognitive Behavioral Therapy for Insomnia (CBT-I)|
15983332|NCT03012425|Device|Acupuncture|
15983333|NCT03012425|Behavioral|questionnaires|
15983334|NCT03012425|Other|Diurnal Cortisol|saliva test
15983335|NCT03012412|Behavioral|Mindfulness Based Program for Infertility|The Mindfulness Based Program for Infertility is a manualized group psychological intervention derived from contextual or 3rd wave cognitive-behavioral therapies intended to develop mindfulness and acceptance skills, as well as to promote perceptions of self-efficacy to deal with the demands of an infertility diagnosis and medical treatment. It comprises 10 weekly sessions of approximately 2hr each, run in small groups (ranging from 10 to 13 participants).
15983336|NCT03012399|Behavioral|Hypnosedation|Undergo hypnosedation
15983337|NCT03012399|Other|Questionnaire Administration|Ancillary studies
15983338|NCT03012399|Behavioral|Verbal Support|Speak with min-body specialist
15983339|NCT03012386|Drug|Sildenafil Citrate|phosphodiesterase 5 inhibitor
15983340|NCT03012373|Procedure|Ear acupressure alone|The magnet pellets were placed with adhesive tape at shenmen point of both ears and were pressed 5 times every 5 minutes for 15 minutes then were attached until next treatment and change now one. The patients received this treatment 2 times a week for 4 weeks.
15983341|NCT03012373|Procedure|Electroacupuncture plus ear acupressure|Acupuncture included Hegu (LI 4) and Zusanli (ST 36) on both hands and legs with electrical stimulation was conducted. The frequency of electrical stimulation was 5 Hz and wave form was adjustable. The intensities of the stimulation were increased in 1 mA increments to maximal tolerable intensity. At the same time, The magnet pellets were placed with adhesive tape at shenmen point of both ears and were pressed 5 times every 5 minutes for 15 minutes. After 15 minutes treatment, acupuncture needles were removed and magnet pellets were attached until next treatment and change now one. The patients received this treatment 2 times a week for 4 weeks.
15983342|NCT03012360|Drug|ceftriaxone|2 g iv every 24h
15983343|NCT03012360|Drug|ciprofloxacin|400 mg iv every 8h
15983344|NCT03012360|Drug|imipenem|1 g iv every 8h
15983345|NCT03012360|Drug|linezolid|600 mg iv every 12h
15983346|NCT03012360|Drug|placebo|The SSI 0.9% or dextrose 5% used are based on routine procedure in different participating centers.Placebo will be prepared using IV bags, with the same of quantity as IMP
15983347|NCT03012347|Drug|BAY987517|Subjects will be instructed to apply the test article in a split-body and face configuration, to the assigned side of the body (face, arms, torso, and legs), as they normally would before going outdoors for a run, walk or other sport related activity. (Formulation: RB# Y73-161)
15983348|NCT03012347|Drug|BullFrog Gel Sunscreen Land Sport SPF-50|Subjects will be instructed to apply the test article in a split-body and face configuration, to the assigned side of the body (face, arms, torso, and legs), as they normally would before going outdoors for a run, walk or other sport related activity.
15983349|NCT03012334|Drug|Lasmiditan|Dose is based on treatment sequence in 5-way crossover
15983350|NCT03012334|Drug|Alprazolam|Active comparator based on treatment sequence in 5-way crossover
15983351|NCT03012334|Other|Placebo|Placebo comparator based on treatment sequence in 5-way crossover
15983352|NCT03012321|Drug|Olaparib|
15983353|NCT03012321|Drug|Abiraterone Acetate|
15983354|NCT03012321|Drug|Prednisone|
15983355|NCT03012282|Device|Computed Tomography Perfusion Imaging|Undergo CT perfusion sequence
15983356|NCT03012269|Behavioral|Working memory training|
15983357|NCT03012256|Other|Cardio-respiratory management model|Includes scheduled nurse-led self-management support (based on a training program, and tool-kit), advanced care and goal planning, clinical pharmacist education reconciliation, team case rounds, Situation, Background, Assessment and Recommendation (SBAR) communication protocol with primary care, and a standardized transition package
15983750|NCT03009435|Other|prophylactic manual rotation|
15983359|NCT03012243|Procedure|Cholecystostomy|Ultrasound-guided insertion of drain in the gallbladder. The drain is left in the gallbladder until clinical assessment and laboratory analyses show that the acute cholecystitis has been successfully treated.
15983360|NCT03012230|Other|Laboratory Biomarker Analysis|Correlative studies
15983361|NCT03012230|Biological|Pembrolizumab|Given IV
15983362|NCT03012230|Drug|Ruxolitinib Phosphate|Given PO
15983363|NCT03012217|Other|Observational Study|
15983364|NCT03012204|Device|real LFrTMS at unaffected M1|"Compare the effect of LFrTMS at unaffected M1 to that of all sham stimulation on motor rehabilitation after cerebrovascular disease .
~rTMS: Repetitive Transcranial Magnetic Stimulation. Combination Elements: ①6 hertz(Hz) rTMS at unaffected M1 before LFrTMS at unaffected M1 ;②6 Hz rTMS at affected M1;③1 Hz rTMS at unaffected M1.
~The four groups are the combinations of real or sham ①/②/③."
15983365|NCT03012204|Device|real primed LFrTMS at unaffected M1|"Compare the effect of primed LFrTMS at unaffected M1 to that of LFrTMS at unaffected M1 on motor rehabilitation after cerebrovascular disease .
~rTMS: Repetitive Transcranial Magnetic Stimulation. Combination Elements: ①6 hertz(Hz) rTMS at unaffected M1 before LFrTMS at unaffected M1 ;②6 Hz rTMS at affected M1;③1 Hz rTMS at unaffected M1.
~The four groups are the combinations of real or sham ①/②/③."
15983366|NCT03012204|Device|combined rTMS at both M1|"Compare the effect of combined rTMS at both M1 to that of primed LFrTMS at unaffected M1 on motor rehabilitation after cerebrovascular disease .
~rTMS: Repetitive Transcranial Magnetic Stimulation. Combination Elements: ①6 hertz(Hz) rTMS at unaffected M1 before LFrTMS at unaffected M1 ;②6 Hz rTMS at affected M1;③1 Hz rTMS at unaffected M1.
~The four groups are the combinations of real or sham ①/②/③."
15983367|NCT03012204|Device|all sham stimulation|used as controls to eliminate the placebo effect of all kinds of combinated rTMS
15983368|NCT03012191|Drug|Gentamicin Sulfate|Participants will be divided into three cohorts: topical gentamicin; Topical gentamicin with microneedle roller assistance; IV gentamicin. While the intervention is the same drug, the topical gentamicin is compounded into a 0.5% ointment and the IV gentamicin is prepared to 7.5 mg/kg body weight and administered over a 30 minutes.
15983369|NCT03012178|Procedure|Mitral valve surgery|ACC/AHA guideline directed mitral valve repair or replacement
15983370|NCT03012165|Drug|ADX-102 Ophthalmic Drops (0.5%)|ADX-102 Ophthalmic Drops (0.5%) administered twice in two weeks.
15983371|NCT03012165|Drug|ADX-102 Ophthalmic Drops (0.1%)|ADX-102 Ophthalmic Drops (0.1%) administered twice in two weeks.
15983372|NCT03012165|Drug|Vehicle of ADX-102 Ophthalmic Drops|Vehicle of ADX-102 Ophthalmic Drops administered twice in two weeks.
15983373|NCT03012152|Procedure|Standard conservative breast surgery|
15983374|NCT03012152|Procedure|Oncoplastic breast surgery|
15983375|NCT03012126|Behavioral|Healthy Weight Clinic|
15983376|NCT03012126|Behavioral|Healthy Weight and Your Child|
15983377|NCT03012113|Drug|Mirabegron|
15983378|NCT03012113|Other|Short term mild cooling|
15983379|NCT03012113|Drug|Placebo Oral Capsule|
15983380|NCT03012100|Drug|Cyclophosphamide|Given PO
15983381|NCT03012100|Other|Laboratory Biomarker Analysis|Correlative studies
15983382|NCT03012100|Biological|Multi-epitope Folate Receptor Alpha Peptide Vaccine|Given ID
15983383|NCT03012100|Other|Placebo Administration|Given ID
15983384|NCT03012100|Biological|Sargramostim|Given ID
15983385|NCT03012087|Behavioral|MyHealthyChoices|My Healthy Choices explains what opioid pain medications are, assesses and explains the patient's risk factors related to taking opioids, assesses patient preferences about pain medications, and produces a tailored patient report based on the answers. The patient is encouraged to show the report to the treating ED clinician so they can discuss medication options for treating the patient's pain. Following discharge from the ED, intervention group participants discharged with a prescription pain reliever receive messages about safe medication use, storage, and disposal and access to an educational web portal that contains more information on prescription pain medications and safety.
15983386|NCT03012087|Other|Health Risk Assessment|The WellSource health risk assessment content focuses on general health promotion, and the participant's overall health and wellness. A summary report based on the participants' answers is sent to their email address.
15983387|NCT03012074|Behavioral|Type 2 Diabetes Self-Management|Patients with Type 2 Diabetes
15983388|NCT03012061|Drug|Placebo|Placebo is a white powder to be administered using ELLIPTA DPI which hold two individual blister strips, both of which contains lactose monohydrate blended with magnesium stearate.
15983389|NCT03012061|Drug|UMEC|UMEC is a white powder to be administered using ELLIPTA DPI which hold two individual blister strips, one of which contains GSK573719 blended with lactose blended with magnesium stearate and another one contains lactose monohydrate blended with magnesium stearate.
15983390|NCT03012061|Drug|Fluticasone Furoate|FF is a white powder to be administered using ELLIPTA DPI which hold two individual blister strips, one of which contains GW685698 blended with lactose monohydrate and another one contains lactose monohydrate with magnesium stearate.
15983391|NCT03012061|Drug|Albuterol/salbutamol|Albuterol/salbutamol is to be administered via metered-dose inhaler as a rescue drug on need basis throughout the study.
15983392|NCT03012048|Device|Silver-impregnated ceramic tablet|"A silver-impregnated ceramic disk used for drinking water treatment that was developed by engineers at the University of Virginia. When the ceramic disk is placed in a household water storage container, silver diffuses through the porous ceramic into the water at a release rate that is effective for continual disinfection of waterborne pathogens while remaining below the silver drinking water standard. The disk is effective for daily treatment of 10 to 15 liters for at least six months.
~This intervention was removed from the study in July 2017 (approximately at 1 year of follow-up)."
15983393|NCT03012048|Device|Silver-impregnated ceramic water filter|"Silver-impregnated ceramic water filter are well-developed, tested, and widely-used devices. In addition to mechanically removing pathogens, the filter is treated with silver to reduce live pathogens that pass through the filter and to provide residual disinfectant to reduce risk of recontamination after treatment.
~This intervention was replaced with ceramic filters without silver in Dec 2017 (approximately at 1.5 years of follow-up)."
15983394|NCT03012048|Device|Safe-storage water container|The safe-storage water containers used in this study are plastic buckets with a spigot, purchased locally.
15983599|NCT03010540|Drug|MORPHINE PLUS FENTANYL|Effect Of Morphine Plus Fentanyl On Emergence Delirium
15983395|NCT03012035|Other|positive treatment expectations|Before participants undergo the exposure training their expectation of treatment efficacy is manipulated with different information regarding the following treatment. The experimental group will get positive treatment expectations induced with the accurate information, that exposure training refers to the gold standard in psychotherapy to reduce spider fear (= open administration of treatment).
15983396|NCT03012035|Other|neutral treatment expectations|The comparator group will get neutral expectations regarding treatment outcome. To induce neutral treatment expectations about the following exposure training, it is necessary to tell them they are in the comparator group and that they will receive a comparator condition exposure training for diagnostic purposes only (= hidden administration of treatment).
15983397|NCT03012009|Device|full ablative CO2 laser|ablation to the level of de dermal papilla
15983398|NCT03012009|Device|fractional ablative CO2 laser|180 micron HP, pulse 8ms, 15% overlay, 30 W (943J/cm)
15983399|NCT03012009|Drug|MAL|
15983400|NCT03012009|Device|LED lamp|peak wavelength 630 nm, 37J/cm2
15983401|NCT03012009|Drug|lidocaine hydrochloride 2% with epinephrine|
15983402|NCT03011996|Drug|CLR 500mg|Cohort 1: bid for 5 days Cohort 2: bid for 7 days
15983403|NCT03011996|Drug|CJ-12420 100mg|Cohort 1: bid for 5 days Cohort 2: bid for 7 days
15983404|NCT03011996|Drug|CJ-12420 50mg|Cohort 2: bid for 7 days
15983405|NCT03011996|Drug|AMX 1g|Cohort 1: bid for 5 days Cohort 2: bid for 7 days
15983406|NCT03011996|Drug|Pantoprazole 40mg|Cohort 2: bid for 7 days
15983407|NCT03011983|Device|MEG|MEG is a non-invasive functional imaging technique that can measure slow-wave neural activity.
15983408|NCT03011983|Device|MRI|MRI is a non-invasive imaging modality that provides measures of brain structure.
15983409|NCT03011983|Behavioral|Neuropsychology assessment|A battery of tests will be administered by a neuropsychologist to evaluate the cognitive function of adolescents with concussion compared to healthy controls.
15983410|NCT03011970|Drug|Oxytocin|
15983411|NCT03011970|Drug|Placebo|
15983412|NCT03011944|Other|Quality Improvement Program|Nutrition screening, Nutrition consult, Oral Nutritional Supplement will be implemented in the Home Health branches as standard of care.
15983413|NCT03011931|Drug|Simvastatin|20 mg Simvastatin given, Blood draw, Urine collection, Celiac serology testing, DNA sampling, Dietary review
15983414|NCT03011918|Other|Data Collection prior to first fall for all fallers|Weight history. Descriptive analysis of weight history in single event fallers compared to multiple event fallers. Information on use of any nutrition supplementation exposure will also be collected
15983415|NCT03011918|Other|Hgb value|Hgb decline. Descriptive analysis of single event fallers compared to multiple event fallers will be analyzed. Use of nutrition supplement exposure will be collected
15983416|NCT03011918|Other|Vitamin D|Descriptive analysis of vitamin D status of single event fallers compared to multiple event fallers will be analyzed. Use of nutrition supplement exposure will be collected..
15983417|NCT03011918|Other|C-Reactive Protein|Descriptive analysis of C-RP value status of single event fallers as compared to multiple event fallers will be analyzed. Use of nutrition supplement exposure data will be collected.
15983418|NCT03011905|Drug|Dexamethasone|4 ml DexaGalen 4 mg/ml
15983419|NCT03011905|Drug|NaCl (Control)|4 ml NaCl 9 mg/ml
15983420|NCT03011905|Drug|Paracetamol|Premedication and as needed after operation
15983421|NCT03011905|Drug|EtoriCoxib|Premedication and first 2 postoperative days.
15983422|NCT03011905|Drug|Oxycodone|Total of 3 doses of OxyContin postoperatively. OxyNorm as needed.
15983423|NCT03011905|Drug|Ropivacaine|In brachial plexus block
15983424|NCT03011892|Drug|Ruxolitinib 0.15% Cream QD|Ruxolitinib 0.15% cream QD
15983425|NCT03011892|Drug|Ruxolitinib 0.5% Cream QD|Ruxolitinib 0.5% cream QD
15983426|NCT03011892|Drug|Ruxolitinib 1.5% Cream QD|Ruxolitinib 1.5% cream QD
15983427|NCT03011892|Drug|Ruxolitinib 1.5% Cream BID|Ruxolitinib 1.5% cream BID
15983428|NCT03011892|Drug|Triamcinolone 0.1% Cream BID|Triamcinolone 0.1% cream BID
15983429|NCT03011892|Drug|Vehicle Cream BID|Vehicle cream BID
15983430|NCT03011879|Other|clinical pathway|
15983431|NCT03011866|Drug|Wound topically irrigated with 500mg TXA|
15983432|NCT03011866|Drug|1mg/kg/hr TXA intravenous infusion till the last suture|
15983433|NCT03011853|Procedure|Non-invasive and/or invasive mechanical ventilation|Use of Non-invasive and invasive mechanical ventilation, focussing particularly on the first respiratory support mode in ICU
15983434|NCT03011840|Other|Information leaflet|Patient information leaflet with instructions to be carried out before procedure under general anesthesia
15983435|NCT03011827|Other|Fibrinogen and/or platelets administration|Fibrinogen and/or platelets administration to maintain clot amplitude at 10 minutes of the thromboelastometry between 35-40 mm along liver transplant procedure
15983436|NCT03011814|Biological|Durvalumab|Given IV
15983437|NCT03011814|Other|Laboratory Biomarker Analysis|Correlative studies
15983438|NCT03011814|Drug|Lenalidomide|Given PO
15983439|NCT03011801|Behavioral|Interpersonal Therapy|reducing conflict in relationships, increasing social support in relationships, improving communication, reducing depressive symptoms
15983440|NCT03011801|Behavioral|Enhanced usual care|Treatment as Usual, including eclectic and supportive therapy, as well as psychiatric medication
15983441|NCT03011788|Drug|Golytely Oral Solution|Bowel purge prior to,colonoscopy
15983442|NCT03011775|Drug|Pioglitazone 15 mg Tablet|1 tablet per day in the morning for 6 months
15983443|NCT03011775|Drug|Isosorbide Dinitrate 10Mg Tablet|1-2 tablets 2 times a day
15983444|NCT03011775|Drug|Acetylsalicylic Acid 75Mg Tablet|1 tablet per a day
15983445|NCT03011775|Drug|Bisoprolol Fumarate 2.5 MG Oral Tablet|1 tablet per a day
15983446|NCT03011775|Drug|Rosuvastatin Calcium 20 MG Oral Tablet|1 tablet per a day
15983447|NCT03011775|Drug|ramipril 5 MG|1 tablet per a day
15983481|NCT03011528|Drug|Consolidation BuMel|"After induction phase and local treatment (surgery and/or radiotherapy) and before PBSC:
~Busulfan, IV, D-5 to D-2, dosa according to the weight
~Melphalan, IV, D-1, 140 mg/m²
~Peripheral Blood Stem Cell infusion:
~- PBSC infusion, D0, at least 3.10^6 CD34/kg"
15983600|NCT03010540|Drug|Fentanyl|Effect Of Fentanyl Only On Emergence Delirium
15983448|NCT03011762|Device|Computer controlled mandibular positioner|Participants in this arm will complete the computer controlled mandibular positioner test. The study participant, study dentist, and PI are all blinded to the outcome of the CCMP test. Those participants predicted to experience therapeutic success with OAT will have their oral appliance set at the predicted protrusive level; those participants predicted to experience therapeutic failure will have their oral appliance set at a default position. Outcome home sleep tests with the oral appliance in place will be used to determine the accuracy of the prediction.
15983449|NCT03011749|Other|FLT PET/CT|FLT PET/CT before first series of Radium-223 and after 2 series
15983450|NCT03011736|Other|Laboratory Biomarker Analysis|Correlative studies
15983451|NCT03011736|Procedure|Parathyroidectomy|Undergo parathyroidectomy
15983452|NCT03011723|Behavioral|Resource oriented music therapy|"10 weeks of tailored individual music therapy for PWD and a caregiver. Pre and post assessment in addition.
~The music therapy consists of one or more of the following activities:
~Singing
~Listening to live music
~Listening to recorded music
~Dancing
~Conversations about memories/reminiscence
~Exercising to music
~Breathing exercises and relaxing exercises
~The treatment is following the principles of resource oriented music therapy as described by Rolvsjord et al (2005)"
15983453|NCT03011710|Device|ProVari v2.5 (E-cigarette)|An electronic cigarette or e-cigarette is a handheld electronic device that vaporizes a flavored liquid. The user inhales the vapor. The fluid in the e-cigarette, called e-liquid, is usually made of nicotine, propylene glycol, glycerine, and flavorings.
15983454|NCT03011710|Device|Marlboro Gold (Conventional cigarette)|Conventional cigarette
15983455|NCT03011710|Device|Cigarette tip|Placebo device
15983456|NCT03011684|Drug|Tamoxifen|For ER Positive Randomization
15983457|NCT03011684|Drug|Letrozole|For ER Positive Randomization
15983458|NCT03011671|Drug|Acetazolamide|ACZ will be given at an initial dose of 250 mg twice a day (BID) and then escalated to 500 mg BID after 1 week. ACZ will be given on days 1-21 of each cycle.
15983459|NCT03011671|Drug|Temozolomide|For cycle 1 of the maintenance phase, TMZ will administered at 150 mg/m2 on days 1- 5 followed by 23 days with no drug. For cycles 2- 6, TMZ can be increased to 200 mg/m2 at the discretion of the treating investigator.
15983460|NCT03011658|Procedure|venepuncture|for both the groups, HADS questionnaire will be administered to assess the levels of anxiety and depression. The placebo group ( group A) will not be having subjects suffering from oral lichen planus
15983461|NCT03011645|Drug|Ziprasidone|Given by mouth, single dose of 60 mg.
15983462|NCT03011645|Drug|Lorcaserin|Given by mouth, single dose of 20 mg.
15983463|NCT03011645|Drug|Placebo Oral Tablet|Given by mouth, single dose.
15983464|NCT03011632|Drug|Mometasone Nasal|a group of children who will receive a nasal mometasone in an atomiser for three months (one application, once per day) and supplemental 3ml 0.9% Sodium chloride (NaCl) solution in a nasal nebuliser once a day for 3 months
15983465|NCT03011632|Drug|placebo mometasone|a group of children without IgE-dependent hypersensitivity who will receive nasal mometasone placebo in an atomiser for three months (one application, once per day) and supplemental 3ml 0.9% NaCl solution in a nasal nebuliser once a day for 3 months,
15983466|NCT03011619|Behavioral|Usual Standard of Care|medication management, group therapy, and individual therapy.
15983467|NCT03011619|Behavioral|Cognitive Behavioral Therapy Condition (CBT)|CBT, including a sequence of sessions that builds upon prior sessions and planned exercises, including worksheets and journal entries.
15983468|NCT03011606|Procedure|Robotic Surgery|Robotic Surgery after Focal Ablation Therapy
15983469|NCT03011593|Other|Nutrition Support Product|Nutrition support product contains macronutrients, micronutrients, glutamine, and prebiotics. Product is in powder form (41 grams per serving) and is mixed with water or juice before consumption. Taken orally as a nutritional shake twice per day.
15983470|NCT03011580|Dietary Supplement|Fultium-D3|Fultium-D3 (oral cholecalciferol or vitamin D3) will be given to participants in the immediate supplementation arm at a dose of 9,600 IU/day for 8 weeks at V2. At V3, all participants will be given a supply of Fultium-D3 at a dose of 3,200 IU/day.
15983471|NCT03011580|Dietary Supplement|Placebo|3 capsules of placebo will be given daily to participants in the delayed supplementation arm for 8 weeks at V2.
15983472|NCT03011567|Drug|Acetaminophen|Participants will receive acetaminophen for postpartum mild pain relief
15983473|NCT03011567|Drug|Ibuprofen|Participants will receive ibuprofen for postpartum mild pain relief
15983474|NCT03011554|Device|Implantable Miniature Telescope (IMT)|Monocular implantation of the IMT.
15983475|NCT03011541|Procedure|Arm 1|"Procedure/ Surgery: RB (Retrobulbar)
~Retrobulbar injection of Bone Marrow Derived Stem Cells (BMSC)
~Procedure/Surgery: ST (Subtenon)
~Subtenon injection of Bone Marrow Derived Stem Cells (BMSC)
~Procedure/Surgery: IV (Intravenous)
~Intravenous injection of Bone Marrow Derived Stem Cells (BMSC)"
15983476|NCT03011541|Procedure|Arm 2|"Procedure/Surgery: RB (Retrobulbar)
~Retrobulbar injection of Bone Marrow Derived Stem Cells (BMSC)
~Procedure/Surgery: ST (Subtenon)
~Subtenon injection of Bone Marrow Derived Stem Cells (BMSC)
~Procedure/Surgery: IV (Intravenous)
~Intravenous injection of Bone Marrow Derived Stem Cells (BMSC)
~Procedure/Surgery: IVIT (Intravitreal)
~Intravitreal injection of Bone Marrow Derived Stem Cells (BMSC)"
15983477|NCT03011541|Procedure|Arm 3|"Procedure/Surgery: RB (Retrobulbar)
~Retrobulbar injection of Bone Marrow Derived Stem Cells (BMSC)
~Procedure/Surgery: ST (Subtenon)
~Subtenon injection of Bone Marrow Derived Stem Cells (BMSC)
~Procedure/Surgery: IV (Intravenous)
~Intravenous injection of Bone Marrow Derived Stem Cells (BMSC)
~Procedure/Surgery: IO (Intraocular)
~Intraocular injection of Bone Marrow Derived Stem Cells (BMSC) with vitrectomy prior to intraocular injection. For example, may include larger amount of stem cells in the intravitreal cavity, intraneuronal injections or subretinal injections of stem cells."
15983478|NCT03011528|Drug|VDC-IE x2|"Week 1, 5, 9 and week 13:
~Vincristine, IV, D1, 1.5mg/m²
~Doxorubicine, IV, D1-D2, 37.5mg/m²
~Cyclophosphamide, IV, D1, 1.2g/m²
~Week 3, 7, 11 and week 15:
~Ifosfamide, IV, D15 to D19, 1.8g/m²/d
~Etoposide, IV, D15 to D19, 100mg/m²/d"
15983479|NCT03011528|Drug|VDC-IE|"Week 1 and week 5:
~Vincristine, IV, D1, 1.5mg/m²
~Doxorubicine, IV, D1-D2, 37.5mg/m²
~Cyclophosphamide, IV, D1, 1.2g/m²
~Week 3, and week 7:
~Ifosfamide, IV, D15 to D19, 1.8g/m²/d
~Etoposide, IV, D15 to D19, 100mg/m²/d"
15983480|NCT03011528|Drug|TEMIRI|"Week 9, 12, 15 and week 18:
~Temozolomide, PO, D1 to D5, 150mg/m²/d
~Irinotecan, IV, D1 to D5, 50mg/m²/d"
15983483|NCT03011528|Procedure|Local treatment by surgery|Surgical excision of whole site of the primary tumour and metastatic sites (outside pulmonary sites) can take place before or after the high dose consolidation chemotherapy. Radiotherapy can be added
15983484|NCT03011528|Radiation|Local treatment by radiotherapy|Radiotherapy of whole site of the primary tumour and metastatic sites (outside pulmonary sites) can take place before or after the high dose consolidation chemotherapy
15983485|NCT03011502|Other|Biological samples collection of blood and feces|
15983486|NCT03011489|Device|Vacuum formed aligners|Infants will receive this appliance which is a maxillary plate with nasal stent in addition to taping on the upper lip (taping is a modified step in Figueroa's technique.
15983487|NCT03011476|Drug|Donepezil|"Start with 5 mg/day for 4 weeks
~Increased to 10 mg/day for 8 weeks"
15983488|NCT03011476|Drug|Placebos|"Start with 5 mg/day for 4 weeks
~Increased to 10 mg/day for 8 weeks"
15983489|NCT03011463|Drug|intravenous infusion of 2 mg trospium chloride|intravenous infusion of 2 mg trospium chloride in 20 ml saline within 60 min and 240 ml tap water p.o
15983490|NCT03011463|Drug|oral administration of 30 mg trospium chloride|oral administration of 30 mg trospium chloride with 240 ml tap water
15983491|NCT03011463|Drug|oral administration of 300 mg ranitidine|oral administration of 300 mg ranitidine with 240 ml tap water
15983492|NCT03011463|Drug|oral administration of 500 mg clarithromycin|oral administration of 500 mg clarithromycin with 240 ml tap water
15983493|NCT03011450|Drug|K-877|
15983494|NCT03011450|Drug|Fenofibrate|
15983495|NCT03011450|Drug|Placebo (for K-877)|
15983496|NCT03011437|Other|Esophagogastroduodenoscopy|Esophagogastroduodenoscopy is an examining method for upper gastrointestinal disease.
15983497|NCT03011424|Device|Extracorporeal liver support therapy (ELS)|ELS by using the Molecular Adsorbent Recirculating System (MARS) is based on a modified haemodialysis that allows the removal of water-soluble and protein bound toxins over an albumin-coated high flux membrane against recycled exogenous albumin.
15983498|NCT03011398|Procedure|Orthobiologic Procedures|To observe the improvement in subject-reported clinical outcomes for percutaneous orthopedic procedures used to treat musculoskeletal disorders.
15983499|NCT03011385|Behavioral|Individual Planning|"Participants are filling in the planning forms, referring to their individual physical activity. Both members of the dyad form their own, interdependent plans.
~The following behavior change techniques (BCT) are included in the planning intervention protocol: action planning, barrier identification, prompting self-talk, relapse prevention/coping planning. Applications of all BCT included references to planning."
15983500|NCT03011385|Behavioral|Dyadic Planning|"Participants are filling in the planning forms jointly. Planning refers to physical activity of only one person in the dyad. The other person in the dyad is actively participating in forming plans by the target person.
~The following BCT are included in the planning intervention protocol: action planning, barrier identification, prompting self-talk, relapse prevention/ coping planning. Applications of all BCT included references to planning."
15983501|NCT03011385|Behavioral|Collaborative Planning|Participants are filling in the planning forms jointly. Planning refers to physical activity of both persons in the dyad. Physical activity may be performed jointly by both persons in the dyad. The following BCT are included in the planning intervention protocol: action planning, barrier identification, prompting self-talk, relapse prevention/ coping planning. Applications of all BCT included references to planning.
15983502|NCT03011385|Behavioral|Education|The education group participants receive extended physical activity and healthy nutrition education program. The education includes: (1) the guidelines for physical activity and healthy nutrition, tailored to age and health status of the participants, (2) the examples of exercises and their metabolic equivalent; (3) information about healthy body mass and body composition.
15983503|NCT03011372|Drug|Pemigatinib|"Pemigatinib once a day by mouth for 2 consecutive weeks and 1 week off therapy.
~Participants will receive either the intermittent dose (as written) or continuous dosing."
15983504|NCT03011359|Other|Optimizing B.I (New) PCA mode|In the intervention group, the optimizing B.I PCA mode will be setted. This mode is setted that the amount of administered drug per hour will be increased by 0.3 ml by pressing bolus button (The interval: ~ 6 hr: 1.5 - 3.5 ml, 6-24 hr: 1 - 3 ml, 24 hr ~ : 0.5 - 2.5 ml). Conversely, if the bolus button is not used for 90 minutes, the administered amount of drug per hour is setted to be reduced by 0.1 ml, and the maximum (or minimum) allowable flow rate is 3.5 ml (or 0.5 ml).
15983505|NCT03011359|Other|Conventional PCA mode|(Mode setting; total volume: 150 ml, flow rate: 2 ml, bolus volume: 0.5 ml, and LOT: 10 minutes)
15983506|NCT03011346|Device|Symetis ACURATE neo/TF transfemoral TAVI system|Transcatheter aortic valve implantation of a Symetis ACURATE neo/TF bioprosthesis by transfemoral access, pre-dilatation mandatory.
15983507|NCT03011346|Device|Edwards Sapien 3 Transcatheter Heart Valve|Transcatheter aortic valve implantation of an Edwards Sapien 3 bioprosthesis by transfemoral access.
15983511|NCT03011320|Drug|EC1456|intravenous (IV) bolus dose
15983512|NCT03011320|Drug|99mTc-Etarfolatide|Injection of unlabeled etarfolatide followed by etarfolatide labeled with 740 to 925 megabecquerels (MBq) [20 to 25 millicuries (mCi)] of sodium pertechnetate Tc-99m injection, followed by a single-photon emission tomography (SPECT) or single-photon emission tomography with in-line x-ray computed tomography (SPECT/CT) scan.
15983513|NCT03011307|Drug|Oxytocin|spinal injection of oxytocin
15983514|NCT03011307|Drug|Placebos|spinal injection of placebo
15983515|NCT03011294|Device|Continuous positive airway pressure (CPAP)|
15983516|NCT03011294|Device|Nasal strip|
15983517|NCT03011281|Drug|Tofacitinib|
15983518|NCT03011268|Other|Discontinuation of anti-TNF treatment|Discontinuation of treatment with Infliximab, Adalimumab, and Golimumab in order to record time to relapse occurrences
15983519|NCT03011268|Other|Continuation of anti-TNF treatment|Continuation of treatment with Infliximab, Adalimumab, and Golimumab for 2 years after randomization, then discontinue
15983520|NCT03011255|Biological|peptide specific CTL|Radiation: RT to 60 Gy, 5 x per week，for 6 weeks Biological: Peptide specific CTL Peptide specific CTL will be administered by intravenous injection on day 28 of radiation.
15983521|NCT03011229|Device|Pro Core Needle|Needle will be used in standard fashion utilizing a slow pull technique by an expert endoscopist who is familiar with EUS and use of both needles.
15983522|NCT03011229|Device|medtronic Sharkcore Needle|Needle will be used in standard fashion utilizing a slow pull technique by an expert endoscopist who is familiar with EUS and use of both needles.
15983523|NCT03011216|Behavioral|Adaptive emotional cognitive control training|Is supposed to train ability to continuously update emotional material in working memory.
15983524|NCT03011216|Behavioral|Adaptive non-emotional feature match task|Does not train updating of working memory content; may train reaction time speed, visual search, or concentration abilities.
15983525|NCT03011203|Other|physical exercise|In session II and III participants will perform an exercise test on a bicycle inside and outside the MR scanner.
15983526|NCT03011190|Behavioral|Emotional regulation|Educate people with difficulty in regulating their emotions and help them acquire skills to do so
15983527|NCT03011177|Drug|Teneligliptin|teneligliptin 20mg qd
15983528|NCT03011177|Drug|Linagliptin|linagliptin 5mg qd
15983529|NCT03011164|Procedure|Walk and Run|Once participants are eligible, they will undergo the experimental procedure. Before data collection, they will walk or run on a treadmill in barefoot for ten minutes to adapt the condition. The a gait analysis system will collect the data while they walk or run on the treadmill in barefoot at selected gait speed.
15983530|NCT03011138|Procedure|Gait velocity|Once participants are eligible, they will undergo the experimental procedure. Before data collection, they will walk on a treadmill in barefoot for ten minutes to adapt the condition. The a gait analysis system will collect the data while they walk on the treadmill in barefoot at selected gait speed.
15983531|NCT03011125|Drug|dexlansoprazole injection|
15983532|NCT03011125|Other|placebo|
15983533|NCT03011112|Procedure|Observational procedure|All the patients will undergo a standard observational procedure: i) diagnosed with KOA; ii) take a radiographic examination (x-ray); iii) assessed by WOMAC; iv) take an physical examination to avoid other disease; iv) take a gait examination on a treadmill in barefoot.
15983534|NCT03011099|Device|Robotic exoskeleton training|During the training, subjects will wear a lower extremity exoskeleton robotic walking device. Subjects will participate in individualized treatment sessions which may include: sit to stand, static and dynamic standing balance, weight shifting, walking, turning, and stand to sit. Each training session will last up to 90 minutes (60 minutes of training with 30 minutes for setup, don/doff of device) and training will be held 5 days per week for 3 weeks with a total of 15 sessions. During the training period, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise.
15983535|NCT03011099|Other|Conventional physical therapy|During the training, subjects will receive conventional physical therapy that is designed to facilitate/promote gait. This will include individualized treatment sessions for each subject and may involve stretching, strengthening, balance training, standing, and gait training. Subjects will not be able to participate in any form of robotic assisted or body weight supported treadmill training. Each training session will last up to 60 minutes and training will be held 5 days per week for 3 weeks with a total of 15 sessions. Consistent with the RET group, subjects will be required to maintain the same amount and level of regular daily physical activity and exercise during study period.
15983536|NCT03011060|Procedure|Neo-adjuvant Chemotherapy|A preoperative chemotherapy based on anthracyclines and taxanes.
15983537|NCT03011060|Drug|Capecitabine|Capecitabine 1000mg/m2 tablets twice a day for 8 cycles.
15983538|NCT03011047|Procedure|endoscopic trans-antral approach|new surgical approach to repair the orbital floor fractures through the maxillary sinus
15983539|NCT03011047|Procedure|trans-orbital surgical approach|through the lower eyelid below the eyelashes ,then down to bone the herniated orbital content will be reduced through this incision traditional surgical approach to repair orbital floor fractures
15983540|NCT03011034|Drug|Talacotuzumab|Talacotuzumab 9 mg/kg will be administered as an IV infusion.
15983541|NCT03011034|Drug|Daratumumab|Daratumumab 16 mg/kg will be administered as an IV infusion.
15983542|NCT03011021|Drug|Liraglutide|Dose escalation of Liraglutide starts from 0.6 mg up to 1.2 mg per day.
15983543|NCT03011021|Biological|UCB-Treg|Receive Treg infusion: 1~5*10^6/kg b.w. in 100ml normal saline
15983544|NCT03011021|Drug|Insulin|Receive insulin following clinician's instruction.
15983545|NCT03011008|Drug|Liraglutide|Dose escalation of liraglutide starts from 0.6 mg up to 1.2 mg per day.
15983546|NCT03011008|Drug|Insulin|Receive insulin following clinician's instruction.
15983547|NCT03010995|Drug|Prazosin|Prazosin will used to study the mechanism involved in nicotine induced acute cardiovascular changes
15983548|NCT03010982|Drug|Tazemetostat and [14C] Tazemetostat|Tazemetostat is a selective oral small molecule inhibitor of EZH2.
15983549|NCT03010969|Procedure|Acute abdominal surgery|Acute abdominal surgery within 72 hours of admission to the department of surgery
15983550|NCT03010943|Device|Virtual reality headset|Feasibility and tolerance
15983551|NCT03010930|Other|Supplementation of diet with MSG|Subjects eat normal diet and consume 8 ounces of vegetable broth with added MSG one time per day for 1 month
15983552|NCT03010930|Other|No supplementation of diet with MSG|Subjects eat normal diet and consume 8 ounces of low glutamate vegetable broth without MSG (sodium-matched with NaCl) one time per day for 1 month
15983553|NCT03010917|Drug|Fish Oil with ethanol and placebo ethanol infusions|Fish Oil with ethanol and placebo ethanol infusions
15983554|NCT03010917|Drug|Placebo with ethanol and placebo ethanol infusions|Placebo with ethanol and placebo ethanol infusions
15983555|NCT03010904|Other|Dietary intervention|
15983556|NCT03010891|Behavioral|The bundle of supportive interventions|usual NICU care +positioning + gentle touch + modulating infant states + facilitated tucking + NNS+ oral sucrose+ routine KMC > 45 minutes
15983557|NCT03010891|Behavioral|Usual NICU care|usual NICU care + positioning + gentle touch +routine KMC < 20 minutes
15983558|NCT03010878|Other|Yoga|"The yoga intervention group addressed pain as a primary variable and balance as a secondary variable and how to best manage these symptoms in the clinic and community.
~Yoga was delivered in sitting, standing, and floor postures"
15983603|NCT03010501|Other|Food Energy Density|Food Energy density manipulated
15983751|NCT03009422|Drug|Local application pentostam|
15983559|NCT03010878|Other|Self-management|The self-management education group was provide once a month through University of Colorado Health Fort Collins Family Medicine Residency Program Pain Management Clinic. The program consisted of lifestyle variations, accountability, modifications, and strategies to management pain in daily life.
15983560|NCT03010865|Drug|Sodium Butyrate|Sodium butyrate is being supplied by T.E. Neesby (Brain White, T.E. Neesby, Inc.) in 730 mg capsules. The company asserts that their material is 98% pure and food grade. We will have identical placebo capsules. Subjects will receive 3 capsules twice daily (morning and late afternoon or evening) for a total of 4380 mg/day.
15983561|NCT03010865|Drug|Placebo Oral Capsule|Placebo Oral Capsule is also being supplied by T.E. Neesby (Brain White, T.E. Neesby, Inc.) and there is no difference from appearance, smell and taste. It contains 1.5 mg sodium butyrate per capsule. Subjects will receive 3 capsules twice daily (morning and late afternoon or evening) for a total of 9 mg/day.
15983562|NCT03010852|Behavioral|Focused incentive spirometer education and monitoring|
15983563|NCT03010839|Procedure|Modified Remote Ischemic Preconditioning|mRIPC will be induced at 24 h, 12 h and 1 h before surgery and once before induction of anesthesia by 3 cycles of 5-min upper limb ischemia and 5-min reperfusion using a blood-pressure cuff inflated to a pressure 200mmHg
15983564|NCT03010839|Procedure|Control|Control group witnout remote ischemic preconditioning
15983565|NCT03010813|Procedure|Robotic single port surgery and NOTES|Robotic single port colorectal surgery; Robotic transanal surgery; Robotic single port urologic surgery; Transoral robotic surgery
15983566|NCT03010800|Device|With Yoni.Fit|Abbreviated Pad Test with Yoni.Fit first, then without Yoni.Fit.
15983567|NCT03010800|Device|Without Yoni.Fit|Abbreviated Pad Test without Yoni.Fit, then with Yoni.Fit.
15983568|NCT03010787|Drug|V565|single ascending dose of V565
15983569|NCT03010787|Drug|V565|Multiple dose
15983570|NCT03010787|Drug|Placebo|Single and multiple dose
15983571|NCT03010787|Drug|V565|Open-label single dose
15983572|NCT03010787|Drug|V565|Open-label single ascending dose
15983573|NCT03010774|Behavioral|Risk Stratification|Every night, subjects will be risk stratified into low-risk or medium- to high-risk using a physiologic risk score, eCART. Subjects who meet the low-risk criteria will not be woken up for routine nighttime vitals (typically at midnight and at 4 am). However, subjects will continue to be woken up for laboratory draws, procedures, or treatments as per usual. Subjects who are medium- to high-risk will continue to be woken up at night for routine nighttime vitals. Alarms for all subjects, including low-risk subjects, will continue to alert nurses in real-time. If the primary nurse of a low-risk subject is alerted of an alarm, the nurse will have to go into the subject's room to turn off the alarm and therefore check on the patient.
15983574|NCT03010774|Behavioral|Usual Care|The subject will continue to receive routine vital sign measurements and charting, standard for the ward or according to the physician orders, including routine spot-check vital signs, regardless of risk level.
15983575|NCT03010761|Drug|escitalopram|antidepressant use for the betel-quid abstinence
15983576|NCT03010761|Drug|Moclobemide|antidepressant use for the betel-quid abstinence
15983577|NCT03010761|Drug|Placebo - Cap|Placebo - Cap
15983578|NCT03010748|Device|Scheimpflug tomography system (Pentacam) measurement|The Scheimpflug tomography system (Pentacam,Oculus GmbH, Wetzlar, Germany) is a rotating Scheimpflug camera that measures 138,000 true elevation points to compute corneal topography. Patients were asked to blink twice and then look at the fixation device. Image acquisition was a 2-second scan of 50 rotational Scheimpflug images through the corneal sighting point, the point where the ray of light from the fovea to the fixation device crossed the cornea. All measurements were performed just after a blink to minimize the effect of tear film alteration on the data. Acceptable maps had at least 10.0 mm of corneal coverage with no extrapolated data in the central 9.0 mm zone.
15983579|NCT03010735|Dietary Supplement|probiotics|Daily take 4.0E+10 CFU of probiotics
15983580|NCT03010735|Dietary Supplement|Placebo|
15983581|NCT03010722|Drug|Regorafenib|"Patients meeting all of the inclusion criteria and none of the exclusion criteria will receive regorafenib 160 mg orally (po) od for 3 weeks of every 4-week cycle. Each cycle will comprise 3 weeks of treatment followed by 1 week without treatment, hereafter described as 3 weeks on/1 week off. Each 160-mg dose will include four regorafenib 40-mg tablets."
15983582|NCT03010696|Other|No interventions, questionnaire, collect specimen|
15983583|NCT03010683|Drug|Liraglutide|Stimulation of Glucagon like peptide-1 receptor by liraglutide (Victoza) 1.8mg once daily as a subcutaneous injection
15983584|NCT03010683|Drug|Metformin|Antidiabetic drug-biguanide class (Glucophage) 1000mg twice daily per os
15983585|NCT03010670|Drug|Oxytocin|A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril) will be administered before the assessment of the neurophysiological measures.
15983586|NCT03010670|Other|Placebo|A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril) will be administered before the assessment of the neurophysiological measures.
15983587|NCT03010657|Other|Experimental intervention|Subjects will be asked to consume certain foods during chemotherapy treatment.
15983588|NCT03010644|Other|n/a - observational study|n/a - observational study
15983589|NCT03010631|Drug|Cohort 1: Lubiprostone Capsule, Fasted|Lubiprostone soft gelatin capsule administered under fasted conditions
15983590|NCT03010631|Drug|Cohort 1: Lubiprostone Sprinkle Formulation, Fasted|Lubiprostone sprinkle formulation administered under fasted conditions
15983591|NCT03010631|Drug|Cohort 2: Lubiprostone Sprinkle Formulation, Fed|Lubiprostone sprinkle formulation administered under fed conditions
15983592|NCT03010631|Drug|Cohort 2: Lubiprostone Sprinkle Formulation, Fasted|Lubiprostone sprinkle formulation administered under fasted conditions
15983593|NCT03010618|Other|Hall technique stainless steel crowns|Primary carious tooth will be treated with stainless steel crowns without local anesthesia or caries removal and the increase in the occlusal vertical dimension will be monitored in two subsequent appointments with measuring canine overbite.
15983594|NCT03010605|Device|Measuring Every Day Device|
15983595|NCT03010605|Other|Physical Therapy|
15983596|NCT03010579|Drug|erythropoietin|Erythropoietin will be administered subcutaneously (s.c.) at the dose of 10 000 IU, three times a week. If necessary,oral ferrous succinate vitamins B12 and folic acid will be administered.
15983597|NCT03010579|Drug|iron supplementation|If necessary, oral ferrous succinate, vitamins B12 and folic acid will be administered.
15983605|NCT03010488|Behavioral|Assigned Sleep Times|Sleep times will be assigned to subjects that will allow them to drive their regular sleep times closer to those they determine to be optimal at study initiation.
15983606|NCT03010488|Device|Goggles|Subjects will wear goggles during saliva collection and Bright Light Therapy
15983607|NCT03010475|Drug|Furosemide|Oral administration A total of three single doses.
15983608|NCT03010475|Drug|Rosuvastatin|Oral administration. A total of three single doses.
15983609|NCT03010475|Drug|SNAC|Oral administration. A total of five single doses.
15983610|NCT03010475|Drug|Semaglutide|Oral administration. Once daily.
15983611|NCT03010462|Device|Nexstim NBS guided active rTMS|Nexstim NBS guided active rTMS + standardized task-oriented therapy
15983612|NCT03010462|Device|Nexstim NBS guided sham rTMS|Nexstim NBS guided sham rTMS + standardized task-oriented therapy
15983613|NCT03010449|Device|Intra-bronchial valve and blood|Intra-bronchial valve implantation in combination with autologous blood instillation
15983614|NCT03010436|Drug|Benralizumab|one injection 30 mg under the subjects skin every 4 weeks for 8 weeks and then every 8 weeks for 24 weeks for a total of 5 treatments.
15983615|NCT03010423|Drug|Nicorandil|Participants received Nicorandil 5 milligram (mg) tablet, three times a day for 12 weeks.
15983616|NCT03010384|Other|Rehabilitation program|
15983617|NCT03010371|Behavioral|Positive Psychotherapy|Positive Psychotherapy (PP) is designed to treat cancer survivors with moderate/severe adaptation difficulties after completing cancer treatments (Ochoa et al., 2010). The objectives are the facilitation and promotion of post-traumatic growth and quality of life, and the reduction of emotional distress (anxiety, depression and post-traumatic symptoms). Secondary consequences of this psychological improvement is a better transition to daily life and the restoration of a good psychosocial functioning (labor reincorporation, adherence to treatments and follow-up, and the adoption of healthy lifestyles). The program consists of twelve sessions of 90 minutes per week in a closed group (5 to 7 participants). Each session focuses on the different topics and tasks defined in the Positive Psychotherapy for cancer survivors (Ochoa et al., 2010).
15983618|NCT03010371|Behavioral|Positive Online Psychotherapy|The Positive Online Psychotherapy (POP) is based on the PP program, but being adapted to an online version. Patients in this experimental condition will have access to a secure virtual platform (supervised and dependent from the Catalan Health Department). The POP consists of twelve weekly sessions of 90 minutes, in a closed-group format (5-7 participants). Patients have a simultaneous group-connection to the online platform, together with a clinical psychologist who lead the tasks according to the focuses of each session.
15983619|NCT03010371|Behavioral|Cognitive Behavioral Therapy|"The Cognitive Behavioral Therapy (CBT) is based on the Cognitive Behavioral Stress Management (Antoni, 2003) and the training program derived from it, Breast Cancer Stress Management and Relaxation Training (B-SMART) by Antoni Michael (2003). In its Spanish version, it is a 10-session therapy aimed to reduce cancer-related emotional distress, facilitating adjustment to illness and greater quality of life. Stress management and relaxation techniques help patients to identify their own stress responses and learn alternative ways of thinking and acting in response to the demands they perceive as highly stressful."
15983620|NCT03010358|Drug|Entospletinib|Given PO
15983621|NCT03010358|Other|Laboratory Biomarker Analysis|Correlative studies
15983622|NCT03010358|Biological|Obinutuzumab|Given IV
15983623|NCT03010358|Other|Pharmacological Study|Correlative studies
15983624|NCT03010345|Device|Osmed self inflating tissue expanders|Osmed self inflating tissue expanders will be placed 21 days before bone grafting the cleft to gain soft tissue coverage
15983625|NCT03010345|Other|Iliac bone graft|Bone grafting the cleft without the use of osmed self inflating tissue expander
15983626|NCT03010332|Biological|Cytomegalovirus-specific Cytotoxic T Lymphocytes (CMV-CTLs)|ATA230 (third-party donor-derived CMV-CTLs) are cytotoxic T lymphocytes that specifically kill cells presenting CMV protein antigens.
15983627|NCT03010319|Device|PriMatrix Dermal Repair Scaffold|Application of PriMatrix to ulcer
15983628|NCT03010319|Device|Secondary Dressings|Dressings to ensure moist wound environment
15983629|NCT03010319|Device|Offloading device|Offloading device to decrease pressure to wound area
15983630|NCT03010306|Other|CASITA|
15983631|NCT03010280|Dietary Supplement|Immunonutrition|Balanced high-protein formula enriched with Omega-3 fatty acids. 200 ml of formula every 8 hours during 10 days preoperatively
15983632|NCT03010280|Dietary Supplement|Balanced high-protein formula|Balanced high-protein formula, without Omega-3 fatty acids. 200 ml of formula every 8 hours during 10 days preoperatively
15983633|NCT03010267|Drug|DP-R213|Investigational product is prescribed to all of randomized subjects
15983634|NCT03010267|Drug|Raloxifene|Investigational product is prescribed to all of randomized subjects
15983635|NCT03010267|Drug|Cholecaliferol|Investigational product is prescribed to all of randomized subjects
15983636|NCT03010254|Device|ACRYSOF® IQ Extended Depth of Focus IOL|Implantable IOL intending to extend the depth of focus and provide continuous functional vision from distance to near while maintaining distance vision and a visual disturbance profile comparable to a monofocal IOL; intended for long-term use over the lifetime of the pseudophakic subject
15983637|NCT03010254|Device|ACRYSOF® IQ Monofocal IOL|Monofocal IOL implanted for long-term use over the lifetime of the pseudophakic subject
15983638|NCT03010254|Procedure|Cataract surgery|IOL bilateral implantation
15983639|NCT03010241|Drug|Tangbi (prescription)|A kind of Granule(Tang bi fang) was made from five kind of Chinese herbs. Other: Standard medical care Standard medical care is in accordance with China Guideline for type 2 diabetes (2013).
15983640|NCT03010241|Drug|Placebo|"Granule(Placebo) is in accordance with Tangbi prescription in appearance, colour, taste.
~Other: Standard medical care. Standard medical care is in accordance with China Guideline for type 2 diabetes (2013)."
15983641|NCT03010228|Biological|VLA15 with Alum|I.M. vaccination with a multivalent outer surface protein A (OspA) based vaccine candidate on days 0, 28 and 56; three different doses
15983642|NCT03010228|Biological|VLA15 without Alum|I.M. vaccination with a multivalent outer surface protein A (OspA) based vaccine candidate on days 0, 28 and 56; three different doses
15983752|NCT03009422|Drug|intra-lisional pentostam|
15983753|NCT03009422|Device|fractional CO2 laser|
15983847|NCT03008720|Device|Transcranial direct current stimulation (tDCS)|
15983643|NCT03010215|Other|Distal Metatarsal Minimally invasive Osteotomy (DMMO)|"Percutaneous dorsal incision at the level of the the distal part of the metatarsal bone, a Shannon burr is introduced at the level of metatarsal neck, with orientation of at approximately 45°, keeping the articular cartilage surface of the metatarsal head as reference point on the superior cortex.
~In this position, under fluoroscopic control, the osteotomy is started following a distal-dorsal and proximal-plantar direction. In this way the metatarsal head moves proximally and dorsally reducing the metatarsal pressure on the plantar ulcer."
15983644|NCT03010202|Drug|Dexamethasone|Comparing the effect of Rituximab infusion With or without Dexamethasone
15983645|NCT03010202|Drug|Rituximab|Comparing maintenance dose of 500mg Rituximab at week 1 and week 24 to Placebo
15983646|NCT03010189|Device|Actigraphy|A small computer in the shape of a wristwatch, that registers movement and assesses sleep quality.
15983647|NCT03010189|Device|Heart-rate variability monitoring|A small computer that registers variation in heart rate, which reflects cardiac autonomic tone.
15983648|NCT03010189|Device|Pupillometry|A handheld infrared camera that sends out a light flash and records the pupil as it contracts and dilates, as a measure of pupillary autonomic tone.
15983649|NCT03010176|Drug|Ulevostinag|IT injection
15983650|NCT03010176|Biological|Pembrolizumab|IV infusion
15983651|NCT03010163|Other|Health Fair|Testing includes weight, height, waist and blood pressure testing. In the event that the participants are unable to meet in person for health measurements, the staff will accept self-reported measurements over the phone.
15983652|NCT03010163|Other|Pedometer|The Fitbit One/Alta/Inspire wireless tracking pedometers measures steps taken, calories burned, distance traveled and sleep pattern. The Fitbit Alta/Inspire also sends reminders to move, which are notifications that remind the wearer to walk at least 250 steps each hour. If the wearer has not walked 250 steps within the hour, the device will vibrate and send an on-screen reminder 10 minutes before the hour. The reminders to move will be turned off during baseline and will be turned on at randomization for all participants.
15983653|NCT03010163|Other|Text Messaging|Daily healthy living advice and encouraging messages about walking through text messages
15983654|NCT03010163|Other|Social Network Support|Family or friends will provide encouragement and remind participants to maintain in a healthy lifestyle and increase daily walking activities
15983655|NCT03010150|Procedure|Biospecimen Collection|Provide blood samples
15983656|NCT03010150|Other|Questionnaire Administration|Ancillary studies
15983657|NCT03010137|Procedure|Incisional Negative Pressure Wound Therapy|
15983658|NCT03010137|Procedure|Standard Closure with Skin Glue|
15983659|NCT03010137|Device|PICO (Smith&Nephew)|Off the shelf, disposable negative pressure wound therapy device. Contains sterile dressing as well as an attached small (pager sized) suction device/canister.
15983660|NCT03010137|Device|Dermabond|Final wound closure with skin glue.
15983661|NCT03010124|Procedure|Blood sample|
15983662|NCT03010111|Other|QFT-IT Test and other blood sampling|In all enrolled health care workers, QFT-IT Test and other blood sampling were performed.
15983663|NCT03010098|Device|Dual-Loop TCI|the investigator modified the effect-site target concentrations by NI.If NI fall down to 46 and keep 46 more than 30 seconds,propofol and remifentanil were infused as feedback automatically to achieve the target NI of 26-46
15983664|NCT03010098|Device|Open-Loop TCI|the investigator modified the effect-site target concentrations of both drugs without minimum or maximum concentration limits without using the Narcotrend monitor only depend on the experience of anesthesiologist.
15983665|NCT03010085|Procedure|Open left-sided hepatectomy|Open left-sided hepatectomy Laparotomy (upper midline, inverted 'L', or Benz incision) Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy
15983666|NCT03010085|Procedure|Laparoscopic left-sided hepatectomy|Trocar insertion Mobilization of the liver Glissonian approach or individual isolation technique Left lateral sectionectomy or left hemihepatectomy
15983667|NCT03010072|Drug|low-dose sucroferric oxyhydroxide|250 mg suroferric oxyhydroxide
15983668|NCT03010072|Drug|high-dose sucroferric oxyhydroxide|2000 mg suroferric oxyhydroxide
15983669|NCT03010059|Drug|JNJ-64041575 (oral suspension formulation)|Participants will receive 240 mg JNJ-64041575 under fasted and fed conditions in Panel 1 as current/new concept oral suspension formulation.
15983670|NCT03010059|Drug|JNJ-64041575 (oral tablet formulation )|Participants will receive 250 mg JNJ-64041575 under fasted and fed conditions in Panel 2 as current/new concept oral tablet formulation.
15983671|NCT03010046|Drug|ANX005|Single ascending dose intravenous infusion
15983672|NCT03010046|Drug|IVIg|IVIg infusion in Cohorts 4b and 5b only. Randomized to ANX005 followed by IVIg or placebo followed by IVIg.
15983673|NCT03010046|Drug|Placebos|0.9% saline intravenous infusion
15983674|NCT03010033|Other|pulmonary rehabilitation|"pulmonary rehabilitation (preoperative part): lower extremity endurance training (using bike ergometer for 3 days, 2 times/day, 15-20min/time) or stair climbing training (3 days, 2 times/day, 30min/time), keep dyspnea index (Borg) score between 5 to 7 points. And inspiratory muscle training (using threshold inspiratory muscle trainer for 3 days, 5 times/day, 2 sessions/time, every session includes 10-20 cycle respirations).
~pulmonary rehabilitation (postoperative part): inspiratory muscle training (using threshold inspiratory muscle trainer until hospital discharge, 3-5 times/day, 1 session/time, every session includes 10-20 cycle respirations)."
15983675|NCT03010020|Behavioral|PCC|Personalized Cognitive Counseling (PCC) sessions will be delivered as described above.
15983676|NCT03010020|Behavioral|Traditional Counseling|GC/CT-infected participants in the standard of care arm (and all GC/CT-negative participants screened for infection) will receive standard post-test counseling in accordance with Peruvian Ministry of Health guidelines.
15983677|NCT03009994|Procedure|Repair of uterine incision|
15983678|NCT03009994|Procedure|Exteriorization of the uterus|
15983679|NCT03009994|Procedure|Non exteriorization of the uterus|
15983680|NCT03009981|Drug|Apalutamide|Take apalutamide 240 mg (four 60 mg tablets) orally once daily, starting on C1D1 and continuing throughout 52-week treatment period.
15983798|NCT03009058|Drug|Irinotecan|Standard of Care chemotherapy
15983799|NCT03009058|Drug|Oxaliplatin|Standard of Care chemotherapy
15983800|NCT03009058|Biological|cetuximab|Standard of Care immunotherapy
15983801|NCT03009058|Biological|Anti-PD1|Standard of Care immunotherapy
15983681|NCT03009981|Drug|LHRH Analogue|"Patients will receive a LHRH analogue therapy of either Degarelix OR Leuprolide with bicalutamide.
~Degarelix:
~Patients will receive subcutaneous injections every 28 days (+/- 3 days). Patients will receive a loading dose of 240 mg (two 120 mg injections) on C1D1, followed by maintenance dose of 80 mg on Day 1 of subsequent cycles.
~Leuprolide:
~Patients treated with leuprolide will receive a 7.5 mg IM injection on C1D1. Patients in arm A ONLY will take this in combination with bicalutamide 50 mg orally once daily starting on C1D1 and continuing for 28 days through completion of cycle 1. Starting on C2D1, patients will continue on one of the following two treatments at investigator discretion:
~Leuprolide 7.5 mg IM injection on Day 1 of subsequent cycles without concurrent bicalutamide.
~OR:
~Leuprolide 22.5 mg IM injection at the following visits without concurrent bicalutamide: C2D1, C5D1, C8D1, and C11D1."
15983682|NCT03009981|Drug|Abiraterone Acetate|Take abiraterone acetate 1000 mg (four 250 mg tablets) orally once daily, starting on C1D1 and continuing throughout 52-week treatment period.
15983683|NCT03009981|Drug|Prednisone|Take two prednisone 5 mg tablets daily, starting on C1D1 and continuing throughout the 52-week treatment period. Following completion of treatment period, patients will taper off prednisone per institutional guidelines. Suggested tapering plan: prednisone 5 mg daily for 7 days, then 2.5 mg daily for 7 days before discontinuing.
15983684|NCT03009968|Other|Post-void residual free voiding trial|Will proceed with voiding trial and assess bladder emptying based on voided amount without checking a post-void residual.
15983685|NCT03009929|Other|Observational study|No intervention, observational only
15983686|NCT03009916|Drug|"cholestagel® (Colesevelam)"|3750mg
15983687|NCT03009916|Drug|Placebos|3750mg
15983688|NCT03009890|Procedure|Surgery (Open Reduction Internal Fixation)|Either volar of dorsal plating or both
15983689|NCT03009890|Procedure|Cast treatment|Hospitals may use their preferred protocol
15983690|NCT03009877|Device|Optiflow F&P 850™ System|"Optiflow™ (Fisher & Paykel Healthcare Limited, East Tamaki, Auckland-New Zealand) offers the ability to comfortably deliver a complete range of oxygen concentrations and flows to extend the traditional boundaries of oxygen therapy.
~This will be placed on the patient immediately upon entering the operating room for 5 minutes, at 50 liters per minute then increased to 70 liters per minute after induction."
15983691|NCT03009877|Device|facemask|We will apply the facemask to the patient immediately upon entering the operating room to pre-oxygenate for five minutes.
15983692|NCT03009877|Drug|Rocuronium|Rocuronium will be administered after the ability to mask ventilate is determined.
15983693|NCT03009877|Drug|Propofol|Propofol infusion 50 micrograms to 150 micrograms will be administered immediately on induction to maintain sedation throughout apneic oxygenation.
15983694|NCT03009877|Drug|Fentanyl|Fentanyl will be administered at the beginning of induction, 2 micrograms per kilogram.
15983695|NCT03009877|Drug|Midazolam|midazolam will be given upon induction, 1-2 milligrams at the anesthesiologist's discretion.
15983696|NCT03009877|Device|C-MAC Premium Video Intubation Platform-KARL STORZ|After patient is induced, the 5.5mm flexible intubation video scope (C-MAC Premium Video Intubation Platform-KARL STORZ) will then be introduced into the oropharynx and advanced into the trachea with the assistance of the C-MAC video laryngoscope (3 or 4 blade based on anesthesiologist's discretion).
15983697|NCT03009864|Drug|Tangshen Prescription|The prescription contains granules of five Chinese herbal medicines, every bag weighs 4.87g, take it one bag each time, two times a day.
15983698|NCT03009864|Drug|Placebos|Treatment with placebo corresponding to each dose of Tangshen Prescription , every bag weighs 4.87g, take it one bag each time, two times a day.
15983699|NCT03009851|Behavioral|OBCHI|Occupation-based cultural heritage intervention emphasizing the cultural background of residents in LTC settings.
15983700|NCT03009838|Drug|Letrozole|oral tablets 2.5 mg
15983701|NCT03009838|Procedure|ovarian drilling|laparoscopic electrocauterization
15983702|NCT03009812|Procedure|Longitudinal uterine incision|
15983703|NCT03009812|Procedure|Transverse uterine incision|
15983704|NCT03009799|Drug|Iota-Carrageenan|One drop in each eye 8 times per day for 7 days (mandatory), then 4 to 8 times/day for the next 14 days until Day 21
15983705|NCT03009799|Drug|Carmellose|1 drop in each eye 8 times/day for 7 days (mandatory), then 4 to 8 times/day for the next 14 days until day 21
15983706|NCT03009786|Other|Measurement of salivary flow|A compress of about 0.95 g which is weighed and then placed under the tongue of the subject for 5 minutes. Once the time has elapsed, the compress is weighed, a simple subtraction determines the weight of saliva produced in 5 minutes
15983707|NCT03009773|Other|rehabilitation multitasking walking.|rehabilitation multitasking walking.
15983708|NCT03009773|Other|Traditional walking rehabilitation|Traditional walking rehabilitation
15983709|NCT03009760|Drug|CJ-12420 50mg(HP-)|CJ-12420 50mg in H. pylori negative subject
15983710|NCT03009760|Drug|CJ-12420 100mg(HP-)|CJ-12420 100mg in H. pylori negative subject
15983711|NCT03009760|Drug|CJ-12420 50mg(HP+)|CJ-12420 50mg in H. pylori positive subject
15983712|NCT03009760|Drug|CJ-12420 100mg(HP+)|CJ-12420 100mg in H. pylori positive subject
15983713|NCT03009734|Drug|ATx201 dermal formulations 2%|Topical application of ATx201 dermal formulations 2%
15983714|NCT03009721|Drug|Other: Not applicable-observational study|
15983715|NCT03009708|Other|Blood samples|Two blood tubes will be collected each week during 8 weeks maximum for the present study. Samples will start at day 30 post-graft and finish at day 90 post-graft maximum.
15983716|NCT03009695|Device|High frequency repetitive dTMS|Focal rTMS will be performed using a Magstim Rapid2 magnetic stimulator (The Magstim Co. Ltd., U.K.) equipped with an H-shaped coil. The used H-coil version is the H-addiction specifically designed to stimulate the insula and the Pre-Frontal Cortex (PFC). This novel H-coil allows direct stimulation of deeper brain regions, like insula (3 cm vs 1.5 cm from the skull). Before each stimulation the resting Motor Threshold (rMT) should be determined. The rMT will be determined over the left primary motor cortex, afterwards the coil will be moved forward 6 cm anterior the motor spot and aligned symmetrically over the PFC and insula. Repetitive dTMS induces long-lasting changes in neural excitability and dopamine release, specifically high-frequency rTMS (18 Hz) enhances cortical excitability.
15983802|NCT03009058|Biological|Ipilimumab|Standard of Care immunotherapy
15983803|NCT03009058|Drug|Cyclophosphamide|Standard of Care chemotherapy
15983804|NCT03009045|Drug|Tedizolid|200mg oral tedizolid one pill per day
15983717|NCT03009695|Device|Low frequency repetitive dTMS|Focal rTMS will be performed using a Magstim Rapid2 magnetic stimulator (The Magstim Co. Ltd., U.K.) equipped with an H-shaped coil. The used H-coil version is the H-addiction specifically designed to stimulate the insula and the Pre-Frontal Cortex (PFC). This novel H-coil allows direct stimulation of deeper brain regions, like insula (3 cm vs 1.5 cm from the skull). Before each stimulation the resting Motor Threshold (rMT) should be determined. The rMT will be determined over the left primary motor cortex, afterwards the coil will be moved forward 6 cm anterior the motor spot and aligned symmetrically over the PFC and insula. Repetitive dTMS induces long-lasting changes in neural excitability and dopamine release, specifically low-frequency rTMS (1 Hz) inhibits cortical excitability.
15983718|NCT03009695|Device|Sham|Sham stimulation will be performed by an H-sham-coil. The H-sham-coil is designed to mimic the auditory artifacts and the scalp sensation evoked by the real coil, without stimulating the brain itself. As in the other groups, in each patient the rMT will be determined before each repetitive dTMS session. The sham stimulation will be performed either at high frequency (50% of subjects) or at low-frequency (50% of subjects), according to the previously described methodologies. All obese people in this group will be submitted at the sight of food preferred (cue).
15983719|NCT03009682|Drug|Olaparib|"Dosage and Schedule : Olaparib 300 mg BID per os every 12 hours administered daily. One cycle is consisted of 21 days.
~Two x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 mL of water. The olaparib tablets should be swallowed whole and not chewed, crushed, dissolved or divided. Olaparib can be taken with a light meal/snack."
15983720|NCT03009656|Other|No study specific interventions|
15983721|NCT03009643|Drug|Inhaled Nitric Oxide|Patients are treated with iNO for 3-5 days.The concentration of inhaled Nitric Oxide is around 5-10ppm.
15983722|NCT03009643|Device|lung protective mechanical ventilation|Mechanical ventilation in the SIMV mode (ventilators Evita 2 or 4,Dräger, Lübeck, Germany) with VT 6-8ml/kg
15983723|NCT03009643|Device|Hemodynamic monitoring|Flotrac/Vigileo (Edwards Lifesciences) are used to guide the fluid management.
15983724|NCT03009630|Procedure|RFA|Patients diagnosed with early-stage NSCLC and signing the informed consent will be performed RFA under the guidance of ENB.
15983725|NCT03009630|Device|ENB|ENB will be used to guide bronchoscope into the accurate location of the lesion during RFA.
15983726|NCT03009617|Behavioral|the educational program and counseling|to examine the effectiveness of web-based health education and consultation on health promotion behaviors of adolescents, their e-health literacy, and their information levels.
15983727|NCT03009604|Drug|Simethicone|Simethicone 40mg oral tablets
15983728|NCT03009604|Drug|Enema|sodium dihydrogen phosphate dihydrate 19.2 gram & disodium hydrogen phosphate dodecahydrate 7.2 gram, in addition to purified water
15983729|NCT03009591|Other|Experimental group|"Longitudinal surface sliding maneuver over the superficial fascia in the anterior region of the arm and the forearm. Applied in 3 strokes.
~Transverse sliding of the flexor muscles of the wrist and fingers.
~Transverse sliding for the biceps brachii muscle.
~Longitudinal surface sliding over the superficial fascia in the posterior arm region.
~Transverse sliding over the brachial triceps tendon.
~Transverse sliding for the pectoralis major muscle.
~Transverse sliding for the posterior axillary region pectoralis major muscle.
~Induction of the posterior axillary fold.
~Induction (crossed hands over the brachial region and forearm).
~Maneuver of transverse planes for the cervicothoracic region.
~Upper limb telescopic maneuver."
15983730|NCT03009578|Drug|Iron Sucrose Injection|iron Intramuscular injections
15983731|NCT03009578|Drug|Ferrous Bisglycinate|oral iron tablets
15983732|NCT03009565|Other|coronary artery disease|
15983733|NCT03009552|Procedure|speckle tracking echocardiography|Speckle tracking echocardiography is used for measuring parameters of cardiac mechanics: left ventricle strain and strain rate; left ventricle twist, untwist and torsion; left atrium strain and strain rate; right ventricle longitudinal strain and strain rate. Echocardiography will be performed within 24 hours of admission, 72 hours after admission and 1 month after discharge.
15983734|NCT03009539|Behavioral|eHealth Familias Unidas Primary Care|"The experimental condition will consist of eHealth Familias Unidas Primary Care. eHealth Familias Unidas Primary Care is an adaptation of the face-to-face version of Familias Unidas. As with face-to-face Familias Unidas, eHealth Familias Unidas Primary Care aims to prevent drug use, sexual risk behaviors, and STIs by improving family functioning. Similar to face-to-face Familias Unidas, eHealth Familias Unidas is a multi-level intervention that targets risk and protective factors at the multiple systems affecting the youth and youths' family."
15983735|NCT03009526|Drug|Sulfadoxine-pyrimethamine|500 mg sulfadoxine and 25 mg pyrimethamine
15983736|NCT03009526|Drug|dihydroartemisinin-piperaquine|40 mg dihydroartemisinin and 320 mg piperaquine
15983737|NCT03009513|Drug|Teneligliptin+Glimepiride|
15983738|NCT03009500|Drug|Bupivacaine|
15983739|NCT03009500|Drug|Depo-Medrol Injectable Product|
15983740|NCT03009500|Other|Saline (Sodium Chloride) solution|
15983741|NCT03009500|Drug|Lidocaine|Each injection of study medications will be preceded by subcutaneous injections of 1 mLs of 2% lidocaine at each injection site to reduce discomfort of the study participants from the injections
15983742|NCT03009487|Drug|Amlodipine/Olmesartan 10/40mg (Combination drug), Rosuvastatin 20mg|co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg), Crestor Tab. 20mg(Rosuvastatin 20mg) and placebo of Olmesartan 40mg
15983743|NCT03009487|Drug|Olmesartan 40 mg, Rosuvastatin 20mg|co-administration of Olmetec tab. 40mg(Olmesartan 40mg), Crestor tab. 20mg(Rosuvastatin 20mg) and placebo of Sevikar Tab 10/40mg(Amlodipine/Olmesartan 10/40mg).
15983744|NCT03009487|Drug|Amlodipine/Olmesartan 10/40mg (Combination drug)|co-administration of Sevikar tab. 10/40mg(Amlodipine/Olmesartan 10/40mg) 10/40mg, Placebo of Olmesartan Tab. 40mg and Placebo of Rosuvastatin 20mg
15983745|NCT03009474|Drug|CJ-30060|Fixed-dose combination drug containing Amlodipine 5 mg and Valsartan 160 mg and Rosuvastatin 10 mg
15983746|NCT03009474|Drug|Exforge tab 5/160mg, Crestor tab 10mg|Co-administration of Amlodipine 5 mg/ Valsartan 160 mg(combination drug) and Rosuvastatin 10 mg
15983747|NCT03009461|Procedure|HAIC|Intra-arterial chemotherapy consisted of infusions of oxaliplatin (35 mg/m2 for 2 hours), followed by 5-fluorouracil (600 mg/m2 for 22 hours) on day1-3 every 4 weeks. For each cycle, leucovorin calcium 200 mg/m2 was intravenously administered for 2 hours from beginning of 5-fluorouracil infusion.
15983805|NCT03009032|Dietary Supplement|PMT25341|
15983754|NCT03009409|Drug|Ketamine Injectable Solution|"Once IV access has been obtained and a facemask has been applied for pre-oxygenation, the loading dose (0.25 mg/kg) of the study drug will be given over 60 seconds and the fixed infusion (5 mcg/kg/min to a maximum of 60 mg/hour) will be initiated by the anesthetist through the pump interface.
~The study drug will be infused at a constant rate of 5 mcg/kg/min throughout the maintenance phase, until the end of the procedure (last suture), up to a maximum cumulative dose of 100 mg. If at any point the anesthesiologist feels that it is clinically necessary to reduce the amount of study drug infusion rate, they may opt to reduce the infusion rate by 50% (to 2.5 mcg/kg/min), or stop the infusion entirely."
15983755|NCT03009409|Other|Placebo|Participants in the control group will receive an equivalent volume bolus and infusion of normal saline to mimic the ketamine infusion in the ketamine group.
15983756|NCT03009396|Drug|RHB-104 (fixed-dose combination: 95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine)|For patients on ACTIVE or PLACEBO in the parent study (RHB-104-01), who were not in remission after 26 weeks
15983757|NCT03009383|Device|A bedside portable endoscopy|
15983758|NCT03009344|Drug|tazemetostat|tazemetostat tablets
15983759|NCT03009331|Procedure|Lungrecruitment manoeuver in prone position.|Postoperative lungrecruitment in prone position, pressure-controlled ventilation peak inspiratory pressure 40 cm H2O combined with PEEP 20 cm H2O during 60 seconds.
15983760|NCT03009331|Procedure|Lungrecruitment manoeuver in supine position.|Postoperative lungrecruitment in supine position, pressure-controlled ventilation peak inspiratory pressure 40 cm H2O combined with PEEP 20 cm H2O during 60 seconds.
15983761|NCT03009318|Other|tumors are confirmed by surgery and pathology|Each patient undergoes both MRS and MET PET scan before surgery. The lesion will be considered as a glioma when either MRS or MET PET results indicated the diagnosis. Pathologic diagnosis will be performed to confirm the final diagnosis.
15983762|NCT03009305|Other|Lower body negative pressure|Model of hypovolemia: Lower body negative pressure down to -80 mmHg (maximum).
15983763|NCT03009305|Device|Continuous positive airway pressure|CPAP of 0, 5 and 10 cm water (H2O).
15983764|NCT03009305|Device|Positive expiratory pressure|PEP of 0, 5 and 10 cm H2O.
15983765|NCT03009292|Drug|lenvatinib|once daily continuous dosing
15983766|NCT03009266|Drug|Sonazoid|Myocardial contrast echocardiography ischemic memory imaging using intravenous administration of Sonazoid
15983767|NCT03009253|Other|order of treatment|the 2 arms have different orders of treatment,participants in arm A accept concurrent chemoradiotherapy at first and then accept evalution for surgery.In arm B,participants accept concurrent chemoradiotherapy at first and then accept evalution for surgery.
15983768|NCT03009240|Drug|Decitabine|Given IV
15983769|NCT03009240|Other|Laboratory Biomarker Analysis|Correlative studies
15983770|NCT03009240|Drug|Pevonedistat|Given IV
15983771|NCT03009240|Other|Pharmacological Study|Correlative studies
15983772|NCT03009227|Procedure|Colonic resection with D2 lymph node dissection|Appropriate to the tumor location colonic resection is performed with D2 lymph node dissection
15983773|NCT03009227|Procedure|Colonic resection with D3 lymph node dissection|Appropriate to the tumor location colonic resection is performed with D3 lymph node dissection
15983774|NCT03009214|Drug|AMC303|AMC303 is a CD44v6 inhibitor blocking receptor tyrosine kinase (RTK) pathways
15983775|NCT03009201|Drug|Doxorubicin Hydrochloride|Given IV
15983776|NCT03009201|Other|Laboratory Biomarker Analysis|Correlative studies
15983777|NCT03009201|Other|Pharmacological Study|Correlative studies
15983778|NCT03009201|Drug|Ribociclib|Given PO
15983779|NCT03009175|Device|Implantable Cardiac Defibrillator, Cardiac Resynchronization Therapy Defibrillator/Pacemaker|
15983780|NCT03009162|Drug|Lasmiditan|200 mg, single oral tablet
15983781|NCT03009149|Other|Aerobic exercise|Aerobic exercise will perform 3 days per week
15983782|NCT03009136|Drug|SCRT|composed of eight herbs: Glycyrrhiza uralensis Fischer 1g Zingiber officinale Roscoe 0.5g Cinnamomum cassia Blume 0.2g, Ephedra sinica Stapf 0.5g, Pinellia ternata Breitenbach 2.67g, Paeonia lactiflora PALL 1g, Asiasarum sieboldi F. Maekawa 0.5g, Schisandra chinensis 2.67g (per 9g of granules)
15983783|NCT03009136|Drug|Placebos|is made of lactose, corn starch and caramel coloring, and has appearance, shape, weight, taste, and color similar to SCRT
15983784|NCT03009123|Other|Erectile dysfunction|Patients with ED are considered belonging to the exposure group.
15983785|NCT03009110|Device|Prophylactic NPWT|The Prevena NPWT system is a small, lightweight, portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary foam and adhesive dressing. It is supplied as a pump with a sterile dressing kit and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 13 to 20 cm and more. The pump maintains negative pressure of -125 mmHg to the wound surface. The device is placed after skin closure.
15983786|NCT03009110|Device|Standard Dressing|Standard wound dressing is routine postoperative wound dressing consisting of layers of gauze and adhesive tape.
15983787|NCT03009097|Biological|DFDBA|13 intrabony defects in chronic periodontitis patients were treated with allograft (DFDBA)
15983788|NCT03009097|Drug|DFDBA with atorvastatin|13 intrabony defects in chronic periodontitis patients were treated with allograft (DFDBA) in combination with atorvastatin gel
15983789|NCT03009084|Behavioral|Lifestyle counseling|Lifestyle counseling of modifiable risk factors of chronic kidney disease: telemonitoring of blood pressure, counseling for smoking cessation, losing weight and increasing the physical activity.
15983790|NCT03009071|Procedure|Doin (conduction exercise)|Doin (conduction exercise) will be combined with acupuncture as active and passive movement to the aim of effective treatment of pain and functional disability. Doin (conduction exercise) sessions will be conducted 2 times a week for 5 weeks.
15983791|NCT03009071|Device|Acupuncture|Acupuncture will be performed with manual stimulation (needle twirling) to evoke de-qi sensation. Acupuncture sessions will be conducted 2 times a week for 5 weeks.
15983792|NCT03009058|Biological|IMM-101|A suspension of heat killed whole cell Mycobacterium obuense NCTC 13365
15983793|NCT03009058|Drug|Gemcitabine|Standard of Care chemotherapy
15983794|NCT03009058|Drug|Nabpaclitaxel|Standard of Care chemotherapy
15983795|NCT03009058|Drug|Capecitabine|Standard of Care chemotherapy
15983796|NCT03009058|Drug|Folinic Acid|Standard of Care chemotherapy
15983797|NCT03009058|Drug|Fluorouracil|Standard of Care chemotherapy
15983809|NCT03009006|Drug|Chlorhexidine 2% gel - Calcium Hydroxide Paste - Non-Setting|Calcium Hydroxide Mixed With Chlorhexidin efficacy of calcium hydroxide and 2 % chlorhexidine gel and combination of both on the anaerobic bacteria, It was clear from the study that calcium hydroxide had limited efficacy against facultative anaerobes, but effective against obligate anaerobes while chlorhexidine only and combination group were effective against all species of anaerobic bacteria
15983810|NCT03009006|Drug|Calcium Hydroxide Paste - Non-Setting|Calcium Hydroxide The antimicrobial activity of calcium hydroxide Ca(OH)2 is related to the release of hydroxyl ions in an aqueous environment leading to damage in the bacterial cytoplasmic membrane, protein denaturation and DNA damage
15983811|NCT03008993|Behavioral|HQIS implementation|
15983812|NCT03008980|Other|Diagnostic Test|
15983813|NCT03008967|Other|Arthroplasty and postoperative rehabilitation.|Patients undergoing total knee or total hip arthroplasty and their response to postoperative rehabilitation.
15983814|NCT03008954|Device|GSP3|Each capsule of GSP3 (previously Attiva) contains 700 mg of a mixture of two food-grade materials: carboxymethylcellulose that is cross-linked with citric acid.
15983815|NCT03008954|Dietary Supplement|Avicel (modified Cellulose)|Each capsule of Avicel contains approximately 350 mg of microcrystalline cellulose
15983816|NCT03008941|Biological|FMT|Capsules with fecal microbiota from healthy donors
15983817|NCT03008941|Other|Placebo|Placebo capsules
15983818|NCT03008928|Behavioral|Alcooquizz|
15983819|NCT03008915|Drug|Aspirin|81mg aspirin taken once per day in the morning
15983820|NCT03008915|Drug|Placebo|placebo taken once per day in the morning
15983821|NCT03008915|Other|Withdrawal from alpha1 antitrypsin replacement therapy|After the completion of the randomization to aspirin and placebo, participants who are on alpha1 replacement therapy are asked to withhold their usual alpha1 antitrypsin replacement therapy for 5 weeks. This is not randomized.
15983822|NCT03008902|Procedure|Near-infrared passive motion capture recording|Full body movement will be recorded during movements using near infrared passive motion capture. This procedure is non-invasive and standard practice in biomechanics labs. Movement will be recorded using an eight-camera system. Retroreflective markers are placed at strategic joint locations to characterize limb movement. Accuracies of the marker positions are sub-millimeter, and allow accurate characterization of limb rotation and translation during movements. Passive reflective marker clusters (3 markers each) will be attached to subjects at 8 locations along the spine. Additional markers will be applied to the manubrium of the sternum, head, pelvis, and extremities. Eight EMG surface electrode pairs will be used to record activation from the left and right erector spinae, latissimus dorsi, trapezius and rectus abdominis muscles during all motions.
15983823|NCT03008889|Drug|N-acetylcysteine|"Participants will start with taking 900mg of NAC once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects will return to the study site to review adverse events.
~In the absence of dose limiting adverse events attributable to the study drug, the dose will be gradually increased to 900 mg twice per day for study days 8-28.
~If this dose is well-tolerated, the dose will be increased to 900 three times per day for study days 29-63."
15983824|NCT03008889|Drug|Placebo|"Participants will start with taking 900mg of the placebo once per day for one week (study days 1-7). At Day 7, parents (or primary caregiver) and subjects will return to the study site to review adverse events. The dosing for the placebo will increase in the same fashion as the active treatment.
~In the absence of dose limiting adverse events attributable to the study drug, the dose will be gradually increased to 900 mg twice per day for study days 8-28.
~If this dose is well-tolerated, the dose will be increased to 900 three times per day for study days 29-63."
15983825|NCT03008876|Drug|Acetaminophen|infants receive acetaminophen for treatment of their PDA
15983826|NCT03008876|Drug|Ibuprofen|infants receive ibuprofen, standard of care in our unit, for treatment of a PDA
15983827|NCT03008863|Other|Education|
15983828|NCT03008850|Drug|MgSo4|"Patients will be randomly allocated to one of two groups:
~Group (M): 2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml (25 mg) MgSO4 will be injected intrathecally.
~Group(P): 2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml normal saline will be injected intrathecally."
15983829|NCT03008850|Drug|Placebo|"Patients will be randomly allocated to one of two groups:
~Group (M): 2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml (25 mg) MgSO4 will be injected intrathecally.
~Group(P): 2 ml (10 mg) of 0.5% heavy bupivacaine plus 0.5 ml normal saline will be injected intrathecally."
15983830|NCT03008837|Device|Military Field Stimulator|The Military Field Stimulator (MFS/Neuro-Stim System), a percutaneous electrical neural field stimulation (PENFS) device evolved from PENS, is currently employed by the United States (US) military and used in the VA (contract number V797D-50453). There is some evidence based on a small trial of 20 postoperative patients that suggests PENS may have greater benefit than acupuncture for acute pain.
15983831|NCT03008837|Other|Standard Therapy|Standard therapy for fibromyalgia will include physical therapy, medication management through the Anesthesiology Pain Clinic, and referral to a pain psychologist.
15983832|NCT03008811|Procedure|Pulmonary vein isolation with cryoballoon catheter.|Device: Arctic Front Advance™ cardiac cryoablation catheter system.
15983833|NCT03008811|Procedure|Pulmonary vein isolation with radiofrequency ablation.|Device: TactiCath™ Quartz irrigated ablation catheter (St. Jude Medical) with aid of 3-D mapping system (EnSite Precision, St. Jude Medical).
15983834|NCT03008798|Drug|Herbal Medicine C-117|C117 formula including 2 herbals and 2 insects
15983835|NCT03008798|Drug|The Placebo of Herbal Medicine C-117|
15983836|NCT03008785|Other|exercise|The training program consisted of aerobic and resisted combined physical exercises performed during 10 weeks, three times weekly with 45 minutes sessions: 5 minutes of warm-up on treadmill, 20 minutes of aerobic exercises and 20 minutes of resistance exercises.
15983837|NCT03008785|Other|isoflavone|Daily supplementation in 1 capsule per day of 100mg of isoflavones (containing 3.3% genistein, 93.5% dadzein and 3.2% glycitein).
15983838|NCT03008785|Other|Placebo|Daily supplementation in 1 capsule per day containing starch of corn.
15983839|NCT03008759|Other|Dentifrice 100% Nano-F|Use of few of dentifrice 100% Nanoencapsulated Fluoride on brushing for one week, twice day.
15983840|NCT03008759|Other|Dentifrice 50% Nano-F|Use of few of dentifrice 50% Nanoencapsulated Fluoride on brushing for one week, twice day.
15983841|NCT03008759|Other|Dentifrice standard|Use of few of dentifrice on brushing for one week, twice day. It's for the positive control of fluorid
15983850|NCT03008707|Procedure|Laparoscopic Peritoneal Lavage|LPL is done by irrigation with at least 6 L of warm saline throughout the abdominal cavity and after that, putting a drain in Douglas cavity through the port sites
15983851|NCT03008694|Device|PET/CT|pet/ct is used as radiotherapy simulation
15983852|NCT03008681|Device|Andresen functional removable orthodontic appliance|Included patients were treated for 24 months with a Functional removable orthodontic appliance, the Andresen activator. The initial checks were performed after 6 weeks with subsequent checks being carried out every 8th week, with the final follow-up at 24 months. The patient underwent functional treatment using the activator described in the protocol with midlines coincidence.
15983853|NCT03008668|Other|acupuncture|a stimulation of the body or auricular points
15983854|NCT03008655|Procedure|intradermal tranexamic acid|intradermal tranexamic acid injection
15983855|NCT03008655|Device|Nd-YAG|six session at two-week interval of low influence 1064 Nd:YAG laser (6 mm spot size, energy fluence 1.2 - 1.4 J/cm 2 at 10 Hz)
15983856|NCT03008642|Other|CO-Rebreathing technique at diagnosis of polycythemia|The intervention consists in one red cell mass determination using the CO-Rebreathing technique at diagnosis of polycythemia, in addition to the regular tests performed in this indication, including RCM isotopic measurement.
15983857|NCT03008629|Device|Podofix nail brace|Podofix nail brace
15983858|NCT03008629|Device|Combiped nail brace|Combiped nail brace
15983859|NCT03008629|Device|Podofix and then Combiped nail brace|Podofix and then Combiped nail brace
15983860|NCT03008616|Biological|AMAG-423 (digoxin immune fab)|AMAG-423 (digoxin immune fab) 3.2 mg/kg, 30 minute IV infusion, every 6 hours x 4 days
15983861|NCT03008616|Other|Placebo|Normal saline, 30 minute IV infusion, every 6 hours x 4 days
15983862|NCT03008603|Device|XACT Robotic System|The XACT device is a real-time, CT image guided, 3-dimensional robotic system. The XACT device is intended for use as an image guided positioning and steering system for insertion of clinical tools, such as biopsy needles, ablation needles, etc., during minimally invasive percutaneous procedures. The system is defined to guide (i.e., position and steer) the tool according to a predefined trajectory following a registration process between the device's coordinate system and real-time CT images.
15983863|NCT03008590|Drug|Naltrexone|One 4.5 mg capsule each evening
15983864|NCT03008590|Drug|Placebo|One capsule each evening
15983865|NCT03008577|Other|Change in ambient operating room temperature|
15983866|NCT03008564|Other|Ultrasound scanning of the lower limb in volunteers|"Several reference points will be marked by anatomical landmarks and/or ultrasound: the anterior superior iliac spine; base of patella; apex of the femoral triangle A measuring tape will be used to measure the anterior superior iliac spine (landmark); the base of the patella (landmark); apex of femoral triangle (ultrasound); and distal most portion of adductor canal (Point B described earlier; ultrasound). We will then measure the ASIS to: 1) base of patella; 2) apex of femoral triangle; and 3) Point B. We will repeat the same procedure on the opposite leg. Once complete, the volunteer will be allowed to dress and leave. The procedure should take approximately 10-20 minutes for each volunteer. The following things will be recorded for each subject:
~Age
~Gender
~Weight
~Height
~BMI
~Distance of ASIS to base of patella
~Distance of Point A to base of patella
~Distance of Point B to base of patella
~Distance of apex of femoral triangle to base of patella"
15983867|NCT03008551|Drug|Empagliflozin|Each participant will receive empagliflozin 25mg daily for 3 months.
15983868|NCT03008551|Drug|Metformin|Each participant will receive metformin 1500mg daily for 3 months.
15983869|NCT03008538|Other|MPM(Mineralized plasmatic matrix).|Preparation of sticky bone graft by addition of growth factors obtained from patient's vebous blood.
15983870|NCT03008538|Other|Autogenous Bone Graft|Socket preservation using autogenous bone graft for preservation of bone width and height for future implant insertion.
15983871|NCT03008525|Biological|subcutaneous and visceral adipose tissue biopsies|
15983872|NCT03008525|Biological|blood samples analysis|
15983873|NCT03008512|Drug|Genexol-PM|
15983874|NCT03008499|Biological|High-activity natural killer|Each treatment: 8~10 billion cells in all, transfuion in 3 times, i.v.
15983875|NCT03008486|Device|Real soft splint (6 cm)|
15983876|NCT03008486|Device|Placebo soft splint (1 cm)|
15983877|NCT03008473|Device|video laryngoscope and chest CT iminge|
15983878|NCT03008473|Device|Conventional intubation of uniblocker|
15983879|NCT03008460|Drug|Eziclen®/Izinova®|Oral solution taken the evening before the colonoscopy
15983880|NCT03008460|Drug|Klean-Prep®|Oral solution taken the evening before the colonoscopy
15983881|NCT03008447|Drug|LEM5|Single dose of lemborexant 5 mg administered within 5 minutes before bedtime.
15983882|NCT03008447|Drug|LEM10|Single dose of lemborexant 10 mg administered within 5 minutes before bedtime.
15983883|NCT03008447|Drug|ZOL|Single dose of zolpidem 6.25 mg administered within 5 minutes before bedtime.
15983884|NCT03008447|Drug|PBO|Single dose of placebo administered within 5 minutes before bedtime.
15983885|NCT03008434|Other|Assigned Interventions|Yoga Group: designed for chronic TBI was provided two times a week for 8 weeks.
15983886|NCT03008421|Dietary Supplement|Astarte® (HSO Health Care GmbH, Vienna, Austria)|oral intake of Astarte® (HSO Health Care GmbH, Vienna, Austria) as described
15983887|NCT03008421|Other|Placebo|Identical-looking oral potato-maltodextrin-based placebo
15983888|NCT03008408|Drug|Everolimus|Given PO
15983889|NCT03008408|Drug|Letrozole|Given PO
15983890|NCT03008408|Drug|Ribociclib|Given PO
15983891|NCT03008395|Behavioral|EMMA|Dialogue tools will be used to develop personally relevant behavioural goals consistent with diabetes self-management
15983892|NCT03008395|Other|Treatment as Usual|Participants randomized to this intervention will receive standard diabetes education sessions. These include group education session and follow up session based on clinician-generated recommendations.
15983893|NCT03008382|Drug|Metoprolol Tartrate Oral Tablet|Metoprolol is a beta-blocker commonly used for mild blood pressure control, and also commonly used for migraine. Subjects with IC/BPS or MPP will start metoprolol at 25 mg once daily and increase to the goal dose of 25 mg 2/day after one week and continue for 8 weeks total.
15983894|NCT03008382|Drug|Placebo Oral Tablet|Subjects with IC/BPS or MPP will start placebo distributed in a double-blind manner. Subjects will take placebo once daily and increase to the goal dose of 25 mg 2/day after one week and continue for 8 weeks total.
15983898|NCT03008356|Dietary Supplement|L-carnitine 1000 mg twice daily|Oral L-carnitine to be taken twice daily for 8 weeks
15983899|NCT03008356|Behavioral|Weekly health coaching calls|Weekly health coaching calls lasting 10-15 minutes
15983900|NCT03008356|Dietary Supplement|Placebo capsules|
15983901|NCT03008343|Device|Irreversible Electroporation|One kind of electric ablation machine from Angiodynamic company (USA)
15983902|NCT03008343|Biological|Natural killer|Each treatment: 8-10 billion cells in all, transfuion in 3 times, i.v.
15983903|NCT03008330|Biological|High-activity natural killer|Each treatment: 8-10 billion cells in all, transfuion in 3 times, i.v.
15983904|NCT03008317|Device|PEEK|a metallic denture base
15983905|NCT03008304|Drug|High-activity natural killer|Each treatment: 8~10 billion cells in all, transfuion in 3 times, i.v.
15983906|NCT03008291|Procedure|CRT-D Implantation|Cardiac resynchronization therapy defibrillator
15983907|NCT03008291|Procedure|CRT-P Implantation|Cardiac resynchronization therapy pacemaker
15983908|NCT03008291|Procedure|Dual Chamber Pacemaker Implantation|
15983911|NCT03008265|Other|Postoperative fascial dehiscence|
15983912|NCT03008252|Other|Lactose breath test|Lactose breath test in NCWS patients with symptoms related to milk and/or milk derivates ingestion.
15983913|NCT03008252|Other|DBPC cow's milk protein challenge|DBPC cow's milk protein challenge in NCWS patients with symptoms related to milk and/or milk derivates ingestion.
15983914|NCT03008239|Device|FiberSense sensor|The FiberSense system is a glucose-monitoring device indicated for continually recording interstitial fluid glucose levels in patients ages 18 and older with insulin dependent diabetes mellitus for the purpose of improving diabetes management.
15983915|NCT03008239|Device|Dexcom Sensor|Dexcom is a continuous glucose monitoring (CGM) system. The display device shows the glucose readings and the trend.
15983916|NCT03008226|Device|Implementation of 9 mm intrabronchial valves|
15983917|NCT03008213|Drug|Netupitant and Palonosetron|300 mg of netupitant and 0.5 mg of palonosetron
15983918|NCT03008200|Device|ultrasound examination|intrauterine fetal pulmonary artery acceleration time to ejection time ratio measurement via ultrasound
15983919|NCT03008187|Drug|SEL24/MEN1703|SEL24/MEN1703 will be given as oral capsules once daily for 14 consecutive days over a 21-day treatment cycle.
15983920|NCT03008174|Other|Early one-way speaking valve (OWSV) assessment|The OWSV assessment by speech language pathologists will be completed at 12-24 hours following percutaneous tracheostomy procedure, which is earlier than the current standard of care of 48 hours or later.
15983921|NCT03008161|Drug|NPT088|IgG1 Fc-GAIM fusion protein, a recombinant fusion protein
15983922|NCT03008161|Drug|Placebo|Placebo
15983923|NCT03008148|Radiation|CCRT|CCRT Phase: Radiation(60 Gy in 2 Gy/fx) + daily Temozolomide (75 mg/m²/day for 6 weeks).
15983924|NCT03008148|Drug|Temozolomide|Temozolomide 150-200 mg/m² Day 1-5 of 28-Day for a maximum of 6 cycles.
15983925|NCT03008148|Drug|Siroquine|"Chemotherapy Phase: Temozolomide 150-200 mg/m² Day 1-5 of 28-Day for a maximum of 6 cycles + Daily JP001(2 tablets once a day) for 24 weeks (4 weeks for each cycle).
~Maintenance Phase: JP001(2 tablets once a day) until disease progression confirmed."
15983926|NCT03008135|Other|Elderly Mobility Scale|The Elderly Mobility Scale was devised to assess the mobility of fragile elderly people, and contains seven items considered as essential for performing the basic activities of the daily routine: Lying down to sitting, sitting to lying down, sitting to standing, standing, Gait/ work on body posture, timed walk (6 meters) and work on Functional Reach/movements?
15983927|NCT03008135|Other|Frailty scale|"6 questions are asked to the person about his or her living conditions to determine the level of frailty. The scale is produced by the board High Health Authority"
15983928|NCT03008122|Other|Placebo|Placebo
15983929|NCT03008122|Biological|Zika Virus Purified Inactivated Vaccine (ZPIV)|Zika Virus Purified Inactivated Vaccine with aluminum hydroxide adjuvant.
15983930|NCT03008109|Drug|EGFR-TK Inhibitor|
15983931|NCT03008096|Procedure|Laparoscopic Sleeve Gastrectomy|Routine Laparoscopic Sleeve Gastrectomy is performed on obese patients supported by Left-Ventricular Assist Device in order to reach a Body Mass Index sufficient for heart transplantation listing.
15983932|NCT03008083|Drug|3 months DAPT|Subjects will continue DAPT with P2Y12 inhibitors and Aspirin (ASA) up to 90 days, after which patients will continue on monotherapy with ASA only, unless contraindications for ASA emerge.
15983933|NCT03008083|Drug|12 months DAPT|Subjects will continue DAPT with P2Y12 inhibitors and Aspirin (ASA) up to 360 days, after which patients will continue on monotherapy with ASA only, unless contraindications for ASA emerge.
15983934|NCT03008070|Drug|IVA337|1200mg
15983935|NCT03008070|Drug|IVA337|800mg
15983936|NCT03008070|Drug|Placebo|Placebo to match
15983937|NCT03008057|Dietary Supplement|vitamin D|vitamin D supplement, 4000 IU tablet daily , one time a day, for 3 months
15983938|NCT03008057|Dietary Supplement|vitamin D placebo|vitamin D placebo tablet (Containing starch powder), one time a day, for 3 months
15983939|NCT03008044|Device|FiberSense system|A novel CGM system based on a FiberSense system placed through the dermis of the patient.
15983940|NCT03008031|Procedure|CESM with a reduced dose of contrast agent|
15983941|NCT03008018|Drug|KA2507|KA2507, an orally-active new chemical entity, is a potent and selective inhibitor of the HDAC6 enzyme, with potential clinical utility in the treatment of melanoma and other solid tumors. KA2507 has been shown to display potent in vitro activity in a range of cancer cell lines, including melanoma cell lines. KA2507 exerts potent in vivo efficacy in a syngeneic model of B16 melanoma. Here, the combination of the agent's direct tumor growth inhibition and metastasis suppression, coupled with its immunotherapeutic activity - demonstrated by decreased expression of STAT-3 and PD-L1 and increased expression of acetylated tubulin, gp100 and MHC Class I in tumors - have been observed.
15983942|NCT03008005|Drug|Placebo Oral Capsule|Placebo is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and contains only dextrose in opaque capsules.
15983943|NCT03008005|Drug|Dronabinol Cap 5 milligrams (MG)|Dronabinol (5mg) is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and is placed in an opaque capsule with dextrose filler.
15983944|NCT03008005|Drug|Dronabinol Cap 10 milligrams (MG)|Dronabinol (10mg) is administered only once (approximately 120 min prior to MR scanning in Visit 3) by the oral route and is placed in an opaque capsule with dextrose filler.
15983945|NCT03007992|Drug|Vinorelbine|Oral vinorelbine will be administered at a daily dose of 30 mg (flat dose without any adaptation to body weight or body surface area) without breaks. Treatment will continue until disease progression, occurrence of unacceptable toxicity, patient's refusal or investigator's decision to stop the treatment.
15983946|NCT03007979|Drug|Palbociclib|Palbociclib at a dose of 125 mg should be taken by mouth with food on a 5 days on/2 days off schedule
15983947|NCT03007979|Drug|Letrozole|Patients who are receiving letrozole will take it daily by mouth, every day of each 28-day cycle, at a dose of 2.5 mg.
15983948|NCT03007979|Drug|Fulvestrant|Patients who are receiving fulvestrant will receive it at a dose of 500 mg as two 5 mL intramuscular injections (one into each buttock) on Days 1 and 15 of Cycle 1 and then on Day 1 of each cycle thereafter.
15983949|NCT03007979|Procedure|Optional research biopsy|Patients may consent to paired tumor biopsies at baseline and time of progression.
15983950|NCT03007979|Drug|Goserelin|Goserelin is given as a subcutaneous injection every 28 days. It is preferred to be given on Day 1 of each cycle, but it may be administered on any day of the treatment cycle to accommodate its specific Q28-day cycle. It will be given to pre- and peri-menopausal women only.
15983951|NCT03007979|Procedure|Research blood draw|"-Blood will be drawn at the following time points for serum, plasma, cfDNA, and germline DNA (only at baseline):
~Baseline
~C1D15
~C2D1
~Every 2-3 months thereafter (to coincide with imaging studies)
~Time of progression"
15983952|NCT03007979|Procedure|Circulating tumor cell blood draw|-Baseline, cycle 2 day 1, post 2 or 3 months of therapy (to coincide with first tumor imaging), and progression
15983953|NCT03007979|Procedure|Tumor biopsy (optional)|-Baseline and progression
15983954|NCT03007966|Procedure|Ilioinguinal / Iliohypogastric Block|Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided ilioinguinal / iliohypogastric block technique.
15983955|NCT03007966|Procedure|Quadratus Lumborum Block|Patients randomized to this arm will receive 25cc's of Bupivacaine 0.25% + Epinephrine 1:200k + Clonidine 1.66mcg/cc administered via an ultrasound guided quadratus lumborum block technique.
15983956|NCT03007966|Drug|Bupivacaine 0.25%|Administered as part of the local anesthetic mixture
15983957|NCT03007966|Drug|Epinephrine 1:200k|Administered as part of the local anesthetic mixture
15983958|NCT03007966|Drug|Clonidine 1.66mcg/cc|Administered as part of the local anesthetic mixture
15983959|NCT03007953|Behavioral|Palliative Care|Care delivered by a nurse, including symptom assessment and management, patient education on lung cancer and treatment options, discussion and communication about preferences for care, psychosocial assessment (including referrals to ancillary services), and patient-centered resources. A personalized treatment plan based on the patient's lung cancer stage, treatment, symptoms and psychosocial needs will be developed by the palliative care team (physician, study nurse) with input from the patient and family member. The study nurse will assess patient's symptoms, implement and monitor the treatment plan applying established End-of- Life Nursing Education Consortium (ELNEC) for Veterans protocols.
15983960|NCT03007940|Other|Coach Site Visit|The coach will conduct a one-day on site visit and will review the walk-through and DDCAT assessment results, and help the change team design an initial change project with Plan-Do-Study-Act (PDSA) cycles. The site visit will use a standardized agenda to ensure NIATx fidelity.
15983961|NCT03007940|Other|Walk-through|Walk-Through: Provider change teams will participate in a coach-led webinar that introduces how to conduct a NIATx walk-through from the co-occurring patient perspective and how to write up results using a standard report format. The walk-through will be conducted within two months of the initial coach site visit.
15983962|NCT03007940|Other|Learning Sessions|The study includes two one-day coach-led learning sessions. The learning sessions promote peer-to-peer sharing about specific goals and objectives. The agenda is tailored to specific treatment service integration issues. The first coach-led learning session teaches providers how to use NIATx process improvement strategies. Providers share walk-through results and initial change projects. Skill development activities include how to: identify change opportunities, use specific tools (e.g., flowcharting), develop PDSA cycles, effectively use data and learning successful change strategies. At the final session, providers present results, sustainment plans, and identify ways for the group to continue to interact.
15983963|NCT03007940|Other|Coaching|A NIATx coach leads the active 12 month implementation phase. The coach works with executive directors, change leaders and teams. After the site visit, a coach will hold individual monthly coaching calls (10 hours in total), and participate in group coaching calls (2 hours in total). In the individual calls, the coach and change team review change projects; discuss successes; and identify ideas for future change projects. Group coaching calls involve change leaders from multiple providers. On these calls, change leaders will discuss common change-related issues, progress, and exchange innovative implementation strategies with their peers. These calls provide opportunities for the coach to share new strategies and discuss implementation issues such as the development of a sustain plan.
15983964|NCT03007940|Other|Business as Usual|Programs in this intervention will continue with their own plans without coaching support to integrate services for individuals with co-occurring substance abuse and mental health disorders. Once the programs in the wait-list control group receive the NIATx Strategy, they will participate in all of the interventions listed above.
15983965|NCT03007927|Drug|Bupivacaine-Dexamethasone|Bupivacaine 1,5 mg/kg-Dexamethasone 2ml 8 mg
15983966|NCT03007927|Drug|Bupivacaine- physiological solution|Bupivacaine 1,5 mg/kg- physiological solution
15983967|NCT03007901|Behavioral|Mindful Climate Action|Educational and Behavioral Training Curriculum: An article describing our proposed program was recently published in Sustainability (1) and is summarized here. Experienced instructors from the UW Integrative Medicine Mindfulness Program will teach the 8-week program. Classes will meet weekly for 2½ hours, with a 6 hour weekend retreat. Twenty to 45 minutes of daily home practice will be guided by audio recordings leading participants through body scan, sitting meditations, breath awareness, and mindful movement. Each of the 2½ hour weekly classes includes topics (~30 min) relating to climate change, energy use, and carbon footprint.
15983968|NCT03007888|Drug|IR CD-LD|Immediate Release Tablet containing carbidopa-levodopa flexible dosing
15983969|NCT03007888|Drug|ER CD-LD|Extended Release capsules containing carbidopa-levodopa flexible dosing
15983970|NCT03007875|Biological|high-activity natural killer|Each treatment: 8~10 billion cells in all, transfuion in 3 times, i.v.
15983971|NCT03007836|Biological|High-activity natural killer|Each treatment: 8~10 billion cells in all, transfuion in 3 times, i.v.
15983972|NCT03007823|Biological|High-activity natural killer|Each treatment: 8-10 billion cells in all, transfuion in 3 times, i.v.
15983973|NCT03007810|Drug|Hemay005|Subjects will be randomized into 6 cohorts(10mg, 20mg, 40mg, 80mg, 120mg, 180mg) orally single dose
15983974|NCT03007810|Drug|Placebos|Subjects will be randomized into 5 cohorts(20mg, 40mg, 80mg, 120mg, 180mg) orally single dose
15983975|NCT03007797|Behavioral|vaccination rate for influenza|
15983976|NCT03007784|Device|transcranial direct current stimulation (tDCS) / Comparison of current intensities|
15983977|NCT03007771|Device|Magnetic Resonance-guided High-Intensity Focused Ultrasound|-Heating will not be performed in two areas of the body near each other (for example, not heating in two different places of the same thigh) to minimize the risk of overheating any one part of the subject's body. Heating a second target site is not mandatory, even if time allows, and the participant may refuse.
15983980|NCT03007745|Device|autoadjusting continuous positive airway pressure|Participants in both arms who are diagnosed with obstructive sleep apnea will be treated with autoadjusting continuous positive airway pressure
15983981|NCT03007732|Drug|Pembrolizumab|200 mg IV every 21 days for up to 13 doses (Arms 1 and 2)
15983982|NCT03007732|Drug|SD-101|5 mg will be delivered to the dominant prostatic tumor lesion at time of fiducial marker placement (1-5 weeks prior to Cycle 1, Day 1) and and 1-3 weeks after Cycle 1 Day 1
15983983|NCT03007732|Drug|Leuprolide acetate|22.5 mg will be given intramuscularly (IM). First injection 3 months prior to Cycle 1 Day 1. Intermittent androgen deprivation therapy will be given every 3 months starting Cycle 1, Day 1 for 3 additional doses.
15983984|NCT03007732|Drug|Abiraterone Acetate|1000 mg oral dosage will be given daily for 3 months prior to Cycle 1, Day 1 and daily for 9 months starting Cycle 1, Day 1.
15983985|NCT03007732|Drug|Prednisone|5 mg oral dosage will be given daily for 3 months prior to Cycle 1 Day 1 and daily for 9 months starting Cycle 1, Day 1.
15983986|NCT03007732|Radiation|Stereotactic Body Radiation Therapy|7 Gy x 5 fractions (35 Gy total) 1-2 weeks after fiducial marker placement and simulation over 10-14 days.
15983987|NCT03007719|Drug|Fluorine F 18 Ara-G|Given IV
15983988|NCT03007719|Procedure|Positron Emission Tomography|Undergo PET/MR imaging
15983989|NCT03007719|Procedure|Magnetic Resonance Imaging|Undergo PET/MR imaging
15983990|NCT03007706|Procedure|Women undergo cesarean section delivery|
15983991|NCT03007693|Drug|JNJ-61393215|Participants will receive JNJ-61393215 for 7 days.
15983992|NCT03007693|Drug|Placebo|Participants will receive JNJ- 61393215 matching placebo for 7 days.
15983993|NCT03007680|Other|Core muscle activation|
15983994|NCT03007654|Device|Mediclore|apply medical device fully around intrauterine surgery area
15983995|NCT03007654|Device|Adept|apply medical device fully around intrauterine surgery area
15983996|NCT03007641|Behavioral|Didactic session|This session will include an overview of the approach to and management of older MBC patients through a case-based presentation.
15983997|NCT03007641|Behavioral|Comprehensive Geriatric Assessment|The Comprehensive Geriatric Assessment (CGA) is a composite of assessment scales evaluating physical, psychological, and social well-being, and is the recommended tool for evaluating an older cancer patient and determining appropriateness of therapy.
15983998|NCT03007628|Device|Magpro X100|In addition to treatment as usual (TAU), participants are supposed to receive ten sessions of MST in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks.
15983999|NCT03007628|Device|ThymatronSystem Ⅳ Electroconvulsive System|In addition to treatment as usual (TAU), participants are supposed to receive ten sessions of modified ECT in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks.
15984000|NCT03007628|Other|Treatment as usual (TAU)|Participants will engage in their intpatient treatment program as-usual.
15984001|NCT03007615|Other|Intimate Lubricant Gel|
15984002|NCT03007602|Other|Upper Extremity Aerobic Exercise|"Range of maximal heart rate is being followed by a polar band during supervised session each week.
~Aerobic exercise is being trained for 30 min-per/day, 3 days/week, 6 weeks. All sessions are being performed by a physiotherapist at cardiopulmonary rehabilitation department."
15984003|NCT03007589|Drug|otc sunscreens|Sunscreens of various SPF levels and ingredients
15984004|NCT03007589|Other|sun protection fabrics|fabrics
15984005|NCT03007589|Other|Optical Filters|Optical filters and surfaces used in solar simulators
15984006|NCT03007576|Biological|RegStem|RegStem, 1.5 ml, one injection
15984007|NCT03007563|Device|bilirubin concentration estimation from smartphone pictures|pictures taken of the skin covering the breast bone
15984008|NCT03007563|Procedure|bilirubin concentration measured in standard blood samples|
15984009|NCT03007563|Device|bilirubin concentration measured by transcutaneous device|
15984010|NCT03007550|Procedure|Laparoscopic total gastrectomy|LTG with D1+/D2-10 lymphadenectomy for patients with clinical stage I (T1N0M0、T1N1M0、T2N0M0) gastric adenocarcinoma
15984052|NCT03007290|Other|Therapeutic drug monitoring|Therapeutic drug monitoring for colistin
15984011|NCT03007550|Procedure|Open total gastrectomy|OTG with D1+/D2-10 lymphadenectomy for patients with clinical stage I (T1N0M0、T1N1M0、T2N0M0) gastric adenocarcinoma
15984012|NCT03007537|Drug|Erythropoietin|10000 IU erythropoietin, subcutaneous injection
15984013|NCT03007537|Drug|0.9% sodium chloride|0.9% sodium chloride 1ml, subcutaneous injection
15984014|NCT03007537|Procedure|cardiac surgery|included valve, coronary artery bypass graft or surgery for congenital heart diseases
15984015|NCT03007524|Drug|High dose Rosuvastatin|20mg/d qN, at least 6 months
15984016|NCT03007524|Drug|Low dose Rosuvastatin|10mg/d qN, at least 6 months
15984017|NCT03007511|Device|Fidmi enhanced enteral feeding device|Fidmi enhanced enteral feeding device is intended to provide nutrition to a patient directly into the stomach through a stoma. The Fidmi PEG device would be investigated in this study on patients suffering from dysphagia, who are scheduled for PEG procedure in order to improve surgical initial insertion, device replacement and removal.
15984018|NCT03007485|Other|Telehealth Pulmonary Rehabilitation|Exercise bikes equipped with software that enables a respiratory therapist to remotely conduct a pulmonary rehabilitation session with a patient while he or she is at home (or at a local community center). The patient's vital signs are continually monitored and the RT is able to remotely alert 911 if a patient is in distress. Educational videos and stretching exercises are also incorporated into this session to mimic what a standard pulmonary rehabilitation session offers.
15984019|NCT03007472|Device|CI532|Cochlear implant
15984020|NCT03007472|Device|Nucleus 7|Sound processor
15984021|NCT03007459|Other|Psychological health|Observing and measuring baseline, and changes in, psychological health through a fitness contest preparation period
15984022|NCT03007459|Other|Physiological health|Observing and measuring baseline, and changes in, physiological health through a fitness contest preparation period
15984023|NCT03007446|Drug|Apatinib|Apatinib :A starting dose of apatinib was administered 500 mg daily
15984024|NCT03007446|Drug|Oxaliplatin|Oxaliplatin:130 mg/m2，d1，ivgtt，in a 21 day cycle
15984025|NCT03007446|Drug|S-1|S-1:40mg，bid，d1-14，po，in a 21 day cycle.
15984026|NCT03007433|Other|400ml of Liquid Nutrient Drink|12MBq Technetium-99m-DTPA will be added as a non-absorbable marker incorporated into liquid nutrient drink Fortisip Vanilla (Nutricia Clinical)
15984027|NCT03007420|Drug|Occipital Nerve Block (ONB) using lidocaine and dexamethosone|Patients enrolled in the study will be randomized to receive either an ONB or a CMBB. The assignment of the procedure will be randomized however neither the patients nor the investigator will be blinded to the procedure. Patients randomized to receive an ONB will receive the block with dexamethasone 2mg (steroid) each site with 3ml 1% lidocaine (local anesthetic), for a total of two sites.
15984028|NCT03007420|Drug|Cervical Medial Branch Block (CMBB) using lidocaine and dexamethosone|Patients enrolled in the study will be randomized to receive either an ONB or a CMBB. The assignment of the procedure will be randomized however neither the patients nor the investigator will be blinded to the procedure. Patients randomized to receive CMBB will receive the block with dexamethasone 1.5mg (steroid) each site with 2 ml 1% lidocaine (local anesthetic), for a total of three sites on each side.
15984029|NCT03007407|Drug|durvalumab|Following three doses of hypofractionated palliative radiation (Days -2, -1, and Day 0 prior to Cycle 1), patients will receive durvalumab (1500 mg IV infusion) on Day 1 for 4 cycles (in combination with tremelimumab). Beginning with Cycle 5 through Cycle 12, patients will receive durvalumab alone (1500 mg/IV infusion) on Day 1 of each 28 day cycle.
15984030|NCT03007407|Drug|Tremelimumab|Following three doses of hypofractionated palliative radiation (Days -2, -1, and Day 0 prior to Cycle 1), patients will receive tremelimumab (75 mg IV infusion) on Day 1 for 4 cycles (in combination with durvalumab).
15984031|NCT03007394|Drug|Lorcaserin|Lorcaserin Capsule
15984032|NCT03007394|Drug|Placebo Oral Capsule|sugar pill to mimic lorcaserin 10mg capsule
15984033|NCT03007381|Drug|Ketorolac Tromethamine|Intravenous analgesic
15984034|NCT03007381|Drug|Normal Saline|Sham comparator
15984035|NCT03007368|Other|Rice|Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.
15984036|NCT03007368|Other|Potato|Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response .
15984037|NCT03007368|Other|Pasta|Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.
15984038|NCT03007368|Other|Sorghum thick porridge|Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.
15984039|NCT03007368|Other|Millet thick porridge|Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.
15984040|NCT03007368|Other|Millet couscous|Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.
15984041|NCT03007368|Other|Millet thin porridge|Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.
15984042|NCT03007368|Other|Millet thin monikuru porridge|Different modern and traditional starch-based foods found in Bamako, Mali were tested for differences in gastric emptying rate and appetitive response.
15984043|NCT03007355|Other|peripheral perfusion index measurement|
15984044|NCT03007342|Drug|Amoxicillin/Clavulanate Potassium 875 mg-125 mg oral tablet|
15984045|NCT03007342|Drug|Placebo|
15984046|NCT03007329|Drug|Exenatide|Exenatide will be combined with Dapagliflozin
15984047|NCT03007329|Drug|Exenatide matching Placebo|Exenatide matching Placebo will be combined with Dapagliflozin
15984048|NCT03007329|Drug|Dapagliflozin|Dapagliflozin, in both arms
15984049|NCT03007316|Procedure|VIP graft|surgical soft tissue grafting concomitant to implant placement
15984050|NCT03007303|Drug|Atypical Antipsychotic|Olanzapine: tablet ,5-20mg, Po q.d. Risperidone: tablet ,1-3 mg, Po q.d. Quetiapine: tablet ,100-400mg, Po b.i.d. ziprasidone : tablet ,40 -80mg, Po b.i.d.
15984051|NCT03007303|Other|atypical antipsychotic combined with MECT|The schizophrenia who matches the indications such as severe negativism, refused to eating or stupor may be treated with antipsychotic combined with MECT, the frequency and times of MECT depend on the state of illness
15984053|NCT03007277|Other|PANJO|PANJO consists on a 6 to 12 home visitation intervention aiming at supporting the parents, supporting their upcoming then relationship with their first newbord child and to help them reaching all services they may need.
15984054|NCT03007264|Device|Cold Atmospheric Plasma|CAP will be applied on one volar arm of volunteers for a total of 2 minutes.
15984055|NCT03007251|Other|"Eurythmy Therapy Movement R"|
15984056|NCT03007251|Other|"Eurythmy Therapy Movement L"|
15984057|NCT03007251|Other|"Eurythmy Therapy Movement B"|
15984058|NCT03007251|Other|Normal movements during walking or standing|
15984059|NCT03007238|Biological|Aldesleukin|Given SC
15984060|NCT03007238|Procedure|Extracorporeal Photopheresis|Undergo ECP
15984061|NCT03007238|Other|Laboratory Biomarker Analysis|Correlative studies
15984062|NCT03007238|Other|Quality-of-Life Assessment|Ancillary studies
15984063|NCT03007225|Drug|Trans-arterial chemoembolization (TACE)|"TACE procedures were performed by experienced radiologists by fluoroscopy. The femoral artery was catheterized under local anesthesia, with a 4F catheter with Copra head configuration. Conventional angiography of the Coeliac and Hepatic arteries to delineate the feeding arteries of the tumors and to exclude portal venous shunting. Then vascular catheter was inserted super-selectively into the branch of the hepatic artery that is the main feeder of the tumor. Chemoembolization then was performed.
~Ten milliliters of Lipiodol was mixed with 100 mg of Doxorubicin hydrochloride and 5ml of Urografin emulsified to create a milky solution. The emulsion slowly was infused into the tumour Gel foam embolization was performed by cutting gel foam sheets into small pledges mannully then mixed with a contrast material and an impirical antibiotic (gentamycin 80 mg). Injection of the mixture slowly under fluoroscopy guidance till complete stasis was achieved."
15984064|NCT03007225|Drug|TACE with Drug Eluting Beads procedure|"The same was done as cTACE till the super selective catheterization of the feeding artery.
~Loading of the beads with Doxorubicin hydrochloride (100-150 mg) was done in vitro an hour before the beginning of catheterization. The loaded beads were then aspirated from the vial into a syringe filled with nonionic contrast medium. Once the feeding artery was identified and catheter was in placement, the loaded beads were infused slowly under fluoroscopic guidance. Two different sizes of DC beads were used, 100-300 μm and 300-500. Starting with the smaller sized beads to occlude the tumoral bed followed by the larger sized one to embolize the proximal vessels. The injection of the loaded beads was performed as selective as possible using either a4F diagnostic catheter (Cobra head catheter; Cordis, USA) or 2.7F microcatheter (Progreat; Terumo, Japan)."
15984065|NCT03007212|Procedure|transarterial chemoembolization versus the standard treatment with sorafinib|TACE procedures were performed by the interventional radiologist through femoral artery approach in all patients. Super-selective cannulation of the main feeders was performed using a microcatheter whenever possible. The c-TACE protocol consisted of intra-arterial infusion of cisplatin 50-100 mg mixed with lipiodol ,Just prior to injection, emulsion is prepared by intensive mixing of equal volumes of cytotoxic drug solution and iodized oil using the pumping method with two syringes and a three way stop cock. Injection is guided by fluoroscopy and results in dense accumulation of the emulsion within the tumor vascular bed. Injection of poor iodized oil up to a maximum volume of 10-20 cc is an option and is followed by embolization of feeding arteries by Gelfoam cubes .Endpoints of conventional TACE are complete filling of the tumor vascular bed with iodized oil and stop-flow in subsegmental and segmental feeding arteries..
15984066|NCT03007173|Procedure|umbilicus preserving surgery|excision of umbilical complex
15984067|NCT03007160|Drug|Potassium Citrate Extended-release Tablets|Daily 3.24g, Po ,Tid, each 1.08g/tablets
15984068|NCT03007147|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo HSCT
15984069|NCT03007147|Drug|Cyclophosphamide|Given IV
15984070|NCT03007147|Drug|Cytarabine|Given IV, SC, or IT
15984071|NCT03007147|Drug|Daunorubicin Hydrochloride|Given IV
15984072|NCT03007147|Drug|Dexamethasone|Given PO or IV
15984073|NCT03007147|Drug|Dexrazoxane Hydrochloride|Given IV
15984074|NCT03007147|Drug|Doxorubicin|Given IV
15984075|NCT03007147|Drug|Etoposide|Given IV
15984076|NCT03007147|Biological|Filgrastim|Given IV
15984077|NCT03007147|Drug|Ifosfamide|Given IV
15984078|NCT03007147|Drug|Imatinib Mesylate|Given PO
15984079|NCT03007147|Other|Laboratory Biomarker Analysis|Correlative studies
15984080|NCT03007147|Drug|Leucovorin Calcium|Given PO or IV
15984081|NCT03007147|Drug|Mercaptopurine|Given PO
15984082|NCT03007147|Drug|Mercaptopurine|Given PO
15984083|NCT03007147|Drug|Methotrexate|Given IT
15984084|NCT03007147|Drug|Methylprednisolone|Given IV
15984085|NCT03007147|Drug|Pegaspargase|Given IV
15984086|NCT03007147|Drug|Prednisolone|Given PO
15984087|NCT03007147|Other|Questionnaire Administration|Ancillary studies
15984088|NCT03007147|Drug|Therapeutic Hydrocortisone|Given IT
15984089|NCT03007147|Drug|Thioguanine|Given PO
15984090|NCT03007147|Drug|Vincristine Sulfate|Given IV
15984091|NCT03007134|Other|Retrospective Chart Review|No intervention.
15984092|NCT03007121|Drug|Morphine intrathecal|Administration of intrathecal injection of 0.3 mg preservative-free morphine in 3 ml NS
15984093|NCT03007121|Drug|Bupivacaine + Sufentanil epidural|Continuous epidural infusion of a mixture containing in 1 ml bupivacaine 0,125% and sufentanil 0,4 mcg at 8 ml/h.
15984094|NCT03007121|Drug|Morphine intravenous|Patiernt-controlled i.v. analgesia with morphine
15984095|NCT03007108|Other|blood withdrawal|
15984096|NCT03007095|Behavioral|Evaluation of the children's social cognitive development|standardized neuropsychological tests
15984097|NCT03007082|Device|Revive SE intracranial thrombectomy device|"Intra-arterial mechanical thrombectomy with Revive SE；
~According to patient condition, the investigator could determine intravenous thrombolysis or not at his/her discretion"
15984098|NCT03007069|Other|Mineralized plasmatic matrix (MPM).|By using venoud blood from the patient, together with bone graft, a centrifuge will be used to obtain the top layer after centrifuging blood at 3000 RPM, for 10 minutes , Which will result if sticky bone graft consistency after mixing.
15984099|NCT03007069|Other|Autogenous bone graft (gold standard).|Exposed implant threads are to be covered with autogenous bone and collagen membrane.
15984491|NCT03004313|Procedure|Pet Scan|Subjects will undergo Pet Scanning for 90 minutes
15984100|NCT03007056|Other|High flow nasal cannula|High flow nasal cannula added to the therapeutic arsenal in neonatal care
15984101|NCT03007043|Other|blood sample|
15984102|NCT03007030|Drug|Brentuximab Vedotin|Given IV
15984103|NCT03007030|Other|Laboratory Biomarker Analysis|Correlative studies
15984104|NCT03007017|Procedure|Deceased donor nephrectomy, prior to cross clamp of donor aorta|"The investigators will perform a prospective investigation of organ recoveries during which the left kidney will be removed prior to cessation of cardiac activity. The second kidney will be removed in the standard fashion. To do this, investigators will adopt techniques used in living donor kidney transplantation. Specifically, a specialized vascular stapler will be used to divide the renal artery at the level of aorta, followed by the vein, at the level of the vena cava. As such, no cuff of abdominal aorta or vena cava will be present on the target kidneys. Once removed from the body, just as is done for living donor kidney transplantation, the kidneys will be immediately flushed. As this ex-vivo flush is already performed for cadaveric kidney transplantation, there should be no additional cost for performing this portion of the procedure. Approximately 15 minutes of additional surgical dissection (prior to stopping the heart) will be required under the proposed study."
15984105|NCT03007017|Procedure|Deceased donor nephrectomy, standard of care|The investigators will remove the right kidney in the stand of care procedures for cadaveric kidney transplantation
15984106|NCT03007004|Drug|Botulinum toxin type B (2500 units / vial)|BTX-B (E2014, Eisai, NerBloc®) was injected subcutaneously from the palmar side into seven locations around interphalangeal metacarpophalangeal joints, targeting the neurovascular bundles just proximal to the A1 pulley (the radial and ulnar sides of the first finger, the radial side of second finger, the ulnar side of the fifth finger and between the second to fifth fingers). Three locations between the second and third fingers, the third and fourth fingers, and the fourth and fifth fingers were injected with 400 U (0.2 ml) of BTX-B. In addition, the radial and ulnar sides of the first finger, the radial side of the second finger, and the ulnar side of the fifth finger were injected with half a dose of BTX-B (200 units; 0.1 ml). A total of 2000 U (1.0 ml) of BTX-B was injected into one hand. Injections were performed using a 30-gauge needle.
15984107|NCT03007004|Drug|Physiological saline|Saline solution was injected subcutaneously from the palmar side into seven locations around interphalangeal metacarpophalangeal joints, targeting the neurovascular bundles just proximal to the A1 pulley (the radial and ulnar sides of the first finger, the radial side of second finger, the ulnar side of the fifth finger and between the second to fifth fingers). Three locations between the second and third fingers, the third and fourth fingers, and the fourth and fifth fingers were injected with saline (0.2 ml). In addition, the radial and ulnar sides of the first finger, the radial side of the second finger, and the ulnar side of the fifth finger were injected with half a dose of saline (0.1 ml). A total of 1.0 ml of saline was injected into one hand. Injections were performed using a 30-gauge needle.
15984108|NCT03006991|Other|therapeutic drug monitoring|dose of methotrexate can be adjusted by therapeutic drug monitoring.
15984109|NCT03006978|Device|TearCare|
15984110|NCT03006978|Device|Warm Compress|
15984111|NCT03006965|Drug|octocog alfa|Pharmacokinetic Characterization of the Hemophilia A Population in Spain using an standalone web-based software
15984112|NCT03006965|Drug|rurioctocog alfa pegol|Pharmacokinetic Characterization of the Hemophilia A Population in Spain using an standalone web-based software
15984113|NCT03006952|Drug|Pentoxifylline|pentoxifylline arm took 400 mg pentoxifylline twice daily plus 50mg losartan daily for 12 weeks.
15984114|NCT03006952|Drug|Losartan|losartan arm took 100mg losartan daily for 12 weeks.
15984115|NCT03006939|Procedure|Cytoreductive surgery|Cytoreductive surgery in terms of tumor debulking is performed in order to promote survival
15984118|NCT03006913|Behavioral|In-person|At all sites, patients randomized to/preferring in-person counseling will meet with a counselor.
15984119|NCT03006913|Behavioral|By phone|Patients in the phone arm will receive a scheduled call at their home.
15984120|NCT03006913|Behavioral|By video|Because low income patients are not likely to have video conference capability at home, this service will be offered at all three hospitals, and patients will have scheduled appointments to come to the hospital to receive counseling delivered through a computer.
15984121|NCT03006900|Other|Pilates|Pilates
15984122|NCT03006900|Other|Massage|Massage
15984123|NCT03006887|Drug|lenvatinib|lenvatinib capsules
15984124|NCT03006887|Drug|pembrolizumab|pembrolizumab intravenous infusion
15984125|NCT03006874|Drug|CJ-12420 100mg QD|CJ-12420 100mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose erosive esophagitis is not endoscopically healed at Week 4, subjects will receive additional 4 week treatment of CJ-12420 100mg.
15984126|NCT03006874|Drug|Esomeprazole 40mg|Esomeprazole 40mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose erosive esophagitis is not endoscopically healed at Week 4, subjects will receive additional 4 week treatment of Esomeprazole 40mg.
15984127|NCT03006874|Drug|CJ-12420 50mg QD|CJ-12420 50mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose erosive esophagitis is not endoscopically healed at Week 4, subjects will receive additional 4 week treatment of CJ-12420 50mg.
15984128|NCT03006861|Dietary Supplement|3.5 mL/d topical creatine|
15984129|NCT03006861|Dietary Supplement|3.5 mL/d topical placebo|
15984130|NCT03006861|Dietary Supplement|21 g/d Oral creatine|
15984131|NCT03006861|Dietary Supplement|21 g/d oral placebo|
15984132|NCT03006848|Drug|Avelumab|Patients will be administered avelumab at a dose of 10 mg/kg intravenously (IV) over 60 minutes on days 1 and 15 of each cycle, with a cycle lasting 28 days. Patients will receive avelumab every 2 weeks in cycles of 28 days for up to 24 months, or 26 cycles.
15984133|NCT03006848|Other|Questionnaires|To assess quality of life, patients will complete questionnaires at four time points.
15984134|NCT03006835|Drug|Clopidogrel|
15984135|NCT03006822|Other|Pressure release 90|This is a massage technique that aims is eliminate myofascial trigger points for to treat muscle pain.
15984136|NCT03006822|Other|Pressure release 60|This is a massage technique that aims is eliminate myofascial trigger points for to treat muscle pain.
15984492|NCT03004313|Procedure|MRI scan|
15984493|NCT03004313|Procedure|Quantitative Sensory Testing (QST)|
15984137|NCT03006822|Other|Pressure release 30|This is a massage technique that aims is eliminate myofascial trigger points for to treat muscle pain.
15984138|NCT03006809|Biological|Fecal Microbiota Transplantation (FMT), OpenBiome|Delivered by colonoscopy, enema or orally (as capsules)
15984139|NCT03006809|Other|pretreatment antibiotics|5 day course (vancomycin PO 500mg bid, metronidazole PO 500mg bid, and neomycin PO 500mg bid) starting 6 days prior FMT
15984140|NCT03006783|Procedure|Cross-face nerve graft|connecting the healthy facial nerve to the affected facial nerve
15984141|NCT03006770|Biological|PLX-PAD|Local intramuscular (IM) injections of PLX-PAD in the index leg.
15984142|NCT03006770|Biological|Placebo|Local intramuscular (IM) injections of Placebo in the index leg.
15984143|NCT03006757|Other|titanium dioxide denture base|
15984144|NCT03006744|Behavioral|Phonological awareness training|Training on specific ways to improve children's phonological awareness by making them more aware of the sound structure of words.
15984145|NCT03006744|Behavioral|Reading enjoyment training|Training on how to make reading enjoyable for children.
15984146|NCT03006731|Behavioral|High Intensity Interval Training|Supervised HIIT sessions will be conducted on a treadmill at Toronto Rehab's Cardiac Rehabilitation and Secondary Prevention Program. During each of the three supervised HIIT sessions each week, subjects will be prescribed 2 protocols with a combination of short to moderate duration exercise of near maximal intensity alternating longer periods of active recovery. The total duration for each HIT session will be approximately 20 minutes with an additional 5 minutes warm-up and cool down period.
15984147|NCT03006731|Behavioral|Moderate Intensity Continuous Exercise|MICE sessions represent the standard of care exercise prescription at TRI. Participants will be instructed to complete 20-60 minutes of continuous aerobic exercise at or around the ventilatory anaerobic threshold achieved on the cardiopulmonary exercise test.
15984148|NCT03006718|Other|PROMIS for Pain Management App|At hospital discharge, the investigators will collect baseline surveys, a blood sample, and download the PROMIS for Pain Management App onto the subject's mobile device. For five consecutive weeks, PROMIS measures will be collected through weekly surveys. The investigators plan to compensate patients for their time. Patients will come back to the hospital after 35 days for a final blood draw and set of surveys. In the event a patient gets readmitted, the investigators will record that admission. The investigators will also collect Proxy PROMIS measures from parents of participants between the ages of 8 and 17-years who have agreed to participate in the study. It is the goal of the investigators to engage one of the parents in the reporting of weekly validated Proxy PROMIS measures.
15984149|NCT03006705|Drug|Nivolumab|Nivolumab: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).
15984150|NCT03006705|Drug|Tegafur-gimeracil-oteracil potassium|Tegafur-gimeracil-oteracil potassium combination drug 40 - 60 mg bid orally in 28 days, followed by 14 days off
15984151|NCT03006705|Drug|Oxaliplatin|Oxaliplatin 130 mg/m2 (body surface area) solution intravenously for 2 hours once-daily, followed by 20 days off.
15984152|NCT03006705|Drug|Capecitabine|Capecitabine 1000 mg2 (body surface area) bid orally in 14 days, followed by 7 days off.
15984153|NCT03006705|Drug|Placebo|Placebo: 360 mg solution intravenously for 30 min in every 3 weeks (maximum 1 year).
15984154|NCT03006692|Other|With arterial blood gas, parameters not being normal can be corrected|If arterial blood gas is analysed answers provide the possibility to make more accurate diagnosis and treat specific abnormal parameters (e.g. electrolytes, oxygenation and so forth).
15984155|NCT03006679|Drug|Meropenem-Vaborbactam|meropenem 2 g and vaborbactam 2 g
15984156|NCT03006679|Drug|Piperacillin/Tazobactam|piperacillin 4 g and tazobactam 0.5 g
15984157|NCT03006666|Behavioral|CHW Training|"CHWs will be trained in DM concepts, motivational interviewing, brief action planning, and stages of behavior change. CHWs will participate in a 105- hour core competency training. CHWs will conduct mock telephone counseling calls with trained standardized patients to enhance skills, gain feedback and develop confidence in these techniques.
~In addition to these training experiences, CHWs will have letter templates, motivational interviewing scripts, and protocols available for patient outreach to standardize and guide patient outreach .
~The completion of the CHW training will be followed by a final examination of knowledge and evaluation of trial encounters with mock participants (consisting of research staff and advisory board members).
~Individuals who do not pass will receive intensive remediation and be required to repeat the examination.
~Community Health Worker Coaching Intervention."
15984158|NCT03006666|Behavioral|Data Only|The teams randomly allocated will not have access to Community Health Workers.
15984159|NCT03006653|Behavioral|Assessment only|Mobile ecological assessment only.
15984160|NCT03006640|Drug|Subcutaneous nitroglycrin|In both groups, a 1 ml filled insulin syringe is delivered to a blinded operator who infiltrated it subcutaneously over 1 cm along the radial artery course. In the NTG group, the syringe contains 200 µg of NTG while in control group the syringe is filled with saline
15984161|NCT03006640|Drug|Subcutaneous saline|In both groups, a 1 ml filled insulin syringe is delivered to a blinded operator who infiltrated it subcutaneously over 1 cm along the radial artery course. In the NTG group, the syringe contains 200 µg of NTG while in control group the syringe is filled with saline
15984162|NCT03006627|Drug|postoperative morphine|Postoperatively, A loading dose of morphine will be given in incremental doses of 1 mg 5 min apart, till the VAS score reached ≤3. The dose of morphine required to reduce the VAS score to ≤3 will be recorded. Subsequently, PCA pump will be configured to deliver a bolus of 1 mg with a lock-out period lasting for 20 min.
15984163|NCT03006614|Drug|NVB|
15984164|NCT03006614|Drug|EPI|
15984165|NCT03006614|Drug|DDP|
15984166|NCT03006614|Drug|CAP|
15984167|NCT03006614|Drug|GEM|
15984168|NCT03006614|Drug|H|
15984169|NCT03006614|Drug|CTX|
15984170|NCT03006614|Drug|T|
15984171|NCT03006601|Other|Office-based accommodative/vergence therapy|Office-based accommodative/vergence therapy (60 minutes per visit, one time per week, 12 weeks) and home reinforcement (15 minutes each time, five times per week, 12 weeks)
15984218|NCT03006263|Procedure|Laparoscopy Assisted Total Gastrectomy|After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy,Laparoscopy Assisted Total Gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.
15984494|NCT03004300|Procedure|Rapid maxillary expansion|Device
15984172|NCT03006588|Procedure|EUS-FNA for RPLN in NPC patients|An EUS probe was introduced to nasopharynx and the retropharyngeal space (RPS) were scanned. The suspicious recurrent RPLN, which was characterized as (1) roughly round and homogeneously hypo-echoic lesion in RPS; (2) located anterior to the carotid sheath which contained the internal carotid artery (ICA) and the internal jugular vein (IJV). Subsequently, guiding by EUS, a dedicated 22G needle was used to puncture into the enlarged RPLN, then the aspiration was conducted The entire EUS-FNA procedure was repeated at least three times till the satisfied strip tissue was obtained. The obtained tissue samples were sent for pathologic detection and the supernatant fluid was for thinprep cytologic test (TCT).
15984173|NCT03006575|Radiation|split-course radiotherapy|split-course chest radiation at 40-51 Gy/10-17f and 15-24 Gy/5-8f
15984174|NCT03006575|Drug|concurrent chemotherapy|weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡) concurrent with chest radiation
15984175|NCT03006562|Drug|Subcutaneous Heparin|5,000 units of subcutaneous heparin before surgery and then every 8 hours after surgery until discharge from the hospital.
15984176|NCT03006549|Behavioral|Emergency Manual (Crisis Checklist)|participants will have an Emergency Manual available to them during the crisis simulation scenario.
15984177|NCT03006536|Device|Li-ESWT|Participants will undergo 6 treatment sessions 2/week with 1 week pause with the Duolith® SD1 machine (Storz, Tägerwilen, Switzerland) according to the company's instructions
15984178|NCT03006523|Procedure|Intrauterine insemination|IUI will be performed with a Wallace® insemination 2 Catheter (Cooper Surgical, Trumbull, CT, USA) depositing 0.2 or 0.5 ml of the sperm sample at the uterine fundus. All IUIs will be performed between 12 p.m. and 4 p.m. After the procedure, 10 min of bed rest will be prescribed. Inseminations will be performed every day of the week, including weekends.
15984179|NCT03006510|Other|Hypoglycemia prediction alert|"In real time, for a patient with a glucose <90 mg/d, using a hypoglycemia prediction model that takes into account patient weight, renal function, eating and insulin dosing a risk score is produced.
~If the Risk score is >35, then the patient is determined to be at risk for hypoglycemia in the next 72 hours.
~If a patient is determined to be at risk for hypoglycemia, the following will occur:
~Alert will be generated and sent via careweb a pager alert system that sends the alert specifically to the current oncall provider The alert also points the provider to the EMR order section where a formal more detailed alert gives recommendationsd for changes in insulin dosing to potentially prevent hypoglycemia."
15984180|NCT03006497|Other|Exercise program based on motor learning principles|The exercise program will include simple activities exposing volunteers in various environmental conditions with a view to adjust their head posture in such conditions. The progressiveness of exercises will be based on the two-dimensional classification system of Gentile (1987). Furthermore, external attentional focus will be used.
15984181|NCT03006484|Other|No intervention|No intervention will be needed.
15984182|NCT03006471|Drug|Dapagliflozin|10 mg, one per day before breakfast during 12 weeks.
15984183|NCT03006471|Drug|Placebo - Cap|one per day before breakfast during 12 weeks.
15984184|NCT03006458|Device|comfilcon A|toric contact lens
15984185|NCT03006458|Device|omafilcon B|toric contact lens
15984186|NCT03006445|Drug|FYU-981|
15984187|NCT03006432|Drug|Oxaliplatin|
15984188|NCT03006432|Drug|5Fluorouracil bolus|
15984189|NCT03006432|Drug|5Fluorouracil continu|
15984190|NCT03006432|Drug|Docetaxel|
15984191|NCT03006432|Drug|Folinic Acid|
15984192|NCT03006419|Drug|Basiliximab|Standard induction therapy
15984193|NCT03006419|Drug|Thymoglobulin|Induction therapy
15984194|NCT03006406|Drug|Long term GnRH-a (3.75mg)|patient in this group only receive GnRH-a 3.75 for pituitary down-regulation
15984197|NCT03006380|Drug|oxytocin|Ecbolic used to reduce blood loss
15984198|NCT03006367|Drug|NFC-1 100 mg|
15984199|NCT03006367|Drug|NFC-1 200 mg|
15984200|NCT03006367|Drug|NFC-1 400 mg|
15984201|NCT03006367|Drug|NFC-1 800 mg|
15984202|NCT03006354|Device|nHFOV|Ventilator (Leoni-Plus Ventilator, Heinen-Lowenstein, Germany) derived high frequency oscillatory ventilation, using binasal prongs
15984203|NCT03006354|Device|nCPAP|Ventilator (Leoni-Plus or Leoni-2 Ventilator, Heinen-Lowenstein, Germany) derived high frequency oscillatory ventilation, using binasal prongs
15984204|NCT03006341|Drug|Dabigatran etexilate|observed upto 12 months
15984205|NCT03006341|Drug|Warfarin|Observed upto 12 months
15984206|NCT03006328|Behavioral|GEM|GEM tool +Health Coaching
15984207|NCT03006328|Behavioral|Enhanced Usual Care|Patients in the EUC arm will receive non-tailored weight management handouts. Patients will follow-up with their primary care teams as needed.
15984208|NCT03006315|Device|Garmin Vivofit device|Participants will be bio-monitored using the Garmin Vivofit mobile wearable device at baseline (at least 1-7 days prior to treatment initiation) and during induction chemotherapy up to completion of 6 cycles. For those patients continuing with ASCT, patients will be bio-monitored up to 90 days post ASCT.
15984209|NCT03006315|Behavioral|Mobile Health quality of life assessements|
15984210|NCT03006302|Drug|Epacadostat|50, 100, 300, or 600 mg taken by mouth twice a day, every day of each cycle
15984211|NCT03006302|Drug|Pembrolizumab|200 mg IV on Day 1 of each cycle
15984212|NCT03006302|Biological|CRS-207|1x10^9 CFU given IV on Day 2 of Cycles 3-6 (Arm A) or Day 2 of Cycles 1-6 (Arm B)
15984213|NCT03006302|Drug|CY|200 mg/m^2 given IV on Day 1 of Cycles 1-2 (Arm A only)
15984214|NCT03006302|Biological|GVAX|5x10^8 cells given as 6 intradermal injections on Day 2 of Cycles 1-2 (Arm A only)
15984215|NCT03006276|Drug|DFN-15 Active|
15984216|NCT03006276|Other|DFN-15 Placebo|
15984217|NCT03006263|Procedure|Totally Laparoscopic Total Gastrectomy|After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy,Totally Laparoscopic Total Gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.
15984352|NCT03005288|Other|Placebo|intravenous infusion every four weeks
15984495|NCT03004300|Procedure|Adenotonsillectomy|Surgery
15984219|NCT03006250|Drug|Desflurane|Desflurane is the volatile agent with low blood: gas partition coefficient (0.42), its uptake and elimination from the body of a patient are rapid, which results in a fast onset of anesthesia and a fast recovery from anesthesia. This property provides desflurane as an ideal agent for the ambulatory anesthesia. However, its pungent odor is concerned to irritate the upper airway and may cause significant respiratory complications.
15984220|NCT03006250|Drug|Sevoflurane|Sevoflurane has a blood: gas partition coefficient of 0.65, which is slightly greater than desflurane. The major advantage over desflurane is the better scented. It is considered to be less airway irritation in LMA anesthesia with smooth induction and recovery.
15984221|NCT03006237|Drug|IS-001|10mg, 20mg or 40 mg IV IS-001 drug administered during surgery
15984222|NCT03006237|Device|da Vinci® Si/Xi Surgical System|robot-assisted minimally invasive hysterectomy surgery performed with da Vinci® Si/Xi Surgical System with Firefly® Fluorescent Imaging
15984223|NCT03006224|Other|One Lung Ventilation|
15984224|NCT03006211|Other|Nitrogen protoxide|
15984225|NCT03006211|Other|Oxygen|
15984226|NCT03006185|Device|Ablative Fractional Carbon Dioxide (CO2) Laser|Ablative Fractional Carbon Dioxide (CO2) Laser treatment is randomly allocated to one of two tests areas in each study participant. Laser treatment consists of targeted ablation of actinic keratoses and field laser treatment of the entire test area. After laser treatment, application of methyl aminolevulinate (MAL), a topical photosensitising agent, is performed. The test area thereafter undergoes 2 hours of daylight photodynamic therapy.
15984227|NCT03006185|Device|Microdermabrasion|Microdermabrasion (processing of the skin with a sandpaper-like material) is randomly allocated to one of two tests areas in each study participant. Microdermabrasion treatment consists of targeted treatment of actinic keratoses and field treatment of the entire test area. Afterwards, application of methyl aminolevulinate (MAL), a topical photosensitising agent, is performed. The test area then undergoes 2 hours of daylight photodynamic therapy.
15984228|NCT03006172|Drug|Inavolisib|Participants will receive oral inavolisib once daily on Days 1-28 of each 28-day cycle (Arms A, B, C, D, E, F) or Days 1-21 of each 21-day cycle (Arm G).
15984229|NCT03006172|Drug|Fulvestrant|Participants will receive fulvestrant 500 mg, administered intramuscularly on Days 1 and 15 of Cycle 1. For subsequent cycles, participants will receive fulvestrant intramuscularly on Day 1 of each cycle.
15984230|NCT03006172|Drug|Letrozole|Participants will receive once daily oral doses of letrozole 2.5 mg on Days 1-28 of each cycle.
15984231|NCT03006172|Drug|Palbociclib|Participants will receive once daily oral doses of palbociclib 125 mg on Days 1-21 of each cycle.
15984232|NCT03006172|Drug|Metformin|Participants will receive oral metformin once daily, starting on Cycle 1, Day 1, as tolerated.
15984233|NCT03006172|Drug|Trastuzumab|Participants will receive trastuzumab, administered by IV infusion on Day 1 of each 21-day cycle, at a loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg for subsequent cycles, until disease progression or unacceptable toxicity.
15984234|NCT03006172|Drug|Pertuzumab|Participants will receive pertuzumab, administered by IV infusion on Day 1 of each 21-day cycle, at a loading dose of 840 mg for Cycle 1 and a dose of 420 mg for subsequent cycles, until disease progression or unacceptable toxicity.
15984235|NCT03006159|Drug|SHR0534|
15984236|NCT03006159|Drug|Placebo|
15984237|NCT03006146|Drug|Sargramostim|Participants will receive a single administration of inhaled sargramostim (either 125 mcg or 250 mcg dose)
15984238|NCT03006120|Procedure|Retroperitoneal hematoma due to cardiac catheterization|
15984239|NCT03006107|Procedure|intraligamentary injection piroxicam|"intraligamentary injection Piroxicam is another NSAID that which has the ability for the treatment of pain, fever and inflammation in the body , has a half-life of 50h in the plasma , oral piroxicam reaches a peak concentration in the plasma within 2 to 4 hours .
~The needle will be placed in the gingival sulcus at a 30- degree angle to the long axis of the tooth then apical pressure is applied until the needle wedged into the periodontal ligament between the tooth and the alveolar crest of the bone"
15984240|NCT03006107|Procedure|Intraligamentary mepevacaine|mepevacaine is an anesthetic (numbing medicine) that blocks the nerve impulses that send pain signals to brain . It is also used as an anesthetic for dental procedures.
15984241|NCT03006081|Drug|Intravitreal Aflibercept injection|Six number of injections at baseline, 1M, 2M, 3M, 4M, and 5M
15984242|NCT03006068|Drug|Upadacitinib (ABT-494)|Upadacitinib (ABT-494) will be administered orally.
15984243|NCT03006068|Drug|Placebo|Placebo will be administered orally.
15984244|NCT03006055|Device|Circulating tumor cells|
15984245|NCT03006042|Drug|Bupivacaine|
15984246|NCT03006029|Drug|TAB08|The initial dose of TAB08 will be 1 µg/kg TAB08 will be administered i.v. over 1 hour weekly for 3 weeks followed by 3 weeks of no treatment; with 6 weeks interval between start of each treatment cycle.
15984247|NCT03006016|Drug|Omega-3 Fatty Acid|The enrollment in the study is proposed by an investigator (surgeon) in each centre at the time of a preoperative visit (V0). Randomization takes place the week before the visit with the investigating surgeon in charge of the patient (V1) when the bariatric procedure is scheduled: omega-3 group (1650 mg of omega-3 / day for 4 weeks without caloric restriction) or placebo group.
15984248|NCT03006016|Other|Placebo|The enrollment in the study is proposed by an investigator (surgeon) in each centre at the time of a preoperative visit (V0). Randomization takes place the week before the visit with the investigating surgeon in charge of the patient (V1) when the bariatric procedure is scheduled: omega-3 group (1650 mg of omega-3 / day for 4 weeks without caloric restriction) or placebo group.
15984249|NCT03006003|Drug|Raloxifene|Raloxifene tratment more than 4 weeks
15984250|NCT03006003|Drug|Alendronate|Alendronic acid 70mg with Colecalciferol 70mcg
15984251|NCT03005990|Other|Exercise training group|The conditioning period (24 weeks) of the exercise intervention was under the supervision of an exercise physiologist. The conditioning protocol included aerobic exercise sessions 3 times per week with 70-85% of maximal heart rate(max HR) for 30 mins and resistance sessions 3 times per week with an intensity of 80% of one-repetition maximum(1RM), 3 sets of 8 repetitions maximum. Each participant will measured the borg rating of perceived exertion scale and heart rate monitor during exercise. Exercise sessions were conducted in the afternoon (3-5 PM).
15984389|NCT03005041|Other|Biotene mouthwash|Participants will rinse their mouth with 15 mL of Biotene mouthwash swishing for 30 seconds.
15984811|NCT03002077|Drug|Rapastinel|Rapastinel pre-filled syringes for IV injections.
15984252|NCT03005977|Procedure|Urodynamics|UDS is to be performed with prolapse reduced by a speculum. The patient will be asked to valsalva three times then cough while seated after 150 ml of fluid is instilled in the bladder and then again at 300 ml. The same provocative measures will be performed at capacity, with the catheter in place and without the catheter if no leak is identified. If the patient leaks at any volume or if the patient leaks during the cough pressure profile (CPP), the test will be considered positive. If the patient does not leak during filling nor during the CPP then the test will be considered negative.
15984253|NCT03005964|Drug|AM001 Cream, 7.5%|Active Cream
15984254|NCT03005964|Drug|Vehicle Cream|Placebo
15984255|NCT03005951|Other|A= Yes Breakfast|Study visit will include analysis of cognitive function (CTET), insulin, glucagon, C-peptide, free fatty acids, and GLP-1 when given breakfast and lunch
15984256|NCT03005951|Other|B=No Breakfast|Study visit will include analysis of cognitive function (CTET), insulin, glucagon, C-peptide, free fatty acids, and GLP-1 when breakfast is skipped and lunch is provided.
15984257|NCT03005938|Procedure|Spinal manipulation|"Spinal manipulation (SM) is a therapeutic intervention performed on spinal articulations in which force is applied to the spine. The selected joint is moved to its end range of motion, followed by application of an rapid impulse or thrust to achieve a gapping of the target joint.
~SM is performed by an orthopedic medical doctor certified in Manual Therapy. After manual evaluation, high-velocity low-amplitude SM is carried out in all regions of the spine, including thoracic adjustments in the prone position, lumbar manipulation in lateral recumbent position, and cervical manipulation in sitting position."
15984258|NCT03005938|Procedure|Imitation of the spinal manipulation|Imitation of the SM physically and visually resembles the act of SM. It comprises placing the patient in the same positions and performing the same movements as during SM but without applying the force in the end range of motion.
15984259|NCT03005925|Device|Smartphone|Smartphone application coupled with a hand dynamometer
15984260|NCT03005925|Other|physical follow up|regular visits with the specialist
15984261|NCT03005912|Device|Conventional acoustic telephony|Quantification of speech comprehension by means of the Hochmair-Schulz-Moser sentence test.
15984262|NCT03005912|Device|Conventional bluetooth telephony|Quantification of speech comprehension by means of the Hochmair-Schulz-Moser sentence test.
15984263|NCT03005912|Device|VoIP acoustic telephony|Quantification of speech comprehension by means of the Hochmair-Schulz-Moser sentence test.
15984264|NCT03005912|Device|VoIP bluetooth telephony|Quantification of speech comprehension by means of the Hochmair-Schulz-Moser sentence test.
15984265|NCT03005899|Drug|SyB P-1501|"After extubation and adequate titration by Fentanyl intravenous injection, the investigational product is applied to outer upper arm or chest on patient who confirmed treatment eligibility. Fentanyl 40 μg per dose is delivered over a 10-minute period by pressing the dosing button by the subject as needed. The 10-minute dosing period is a system lock-out time, allowing for a maximum of 6 doses per hour. One system is operable for 24 hours or until 80 doses are delivered, whichever occurs first.
~Duration of application of the investigational product is 24 hours. Duration of application may be extended for up to 72 hours or until the third system is used, whichever occurs first, if the patient requests it and the specified tests can be performed"
15984266|NCT03005899|Drug|SyB P-1501 placebo|Identical to SyB P-1501 containing hydrogel that contains the active ingredient fentanyl HCI in its structure and appearance but production of an electric current and subsequent drug administration by iontophoresis are prevented because of its modified circuit.
15984267|NCT03005886|Procedure|Periodontal examination|"periodontal examination included the assessment of plaque index (PI), gingival index(GI), probing depth (PD), bleeding on probing (BOP) and clinical attachment level (CAL).
~All subjects underwent a periodontal examination performed by the same periodontitis (ZTÇ) Prior to the study, the examiner was calibrated for reproducibility of PD and CAL measurements"
15984268|NCT03005886|Procedure|GCF sampling|GCF samples were collected using commercially available periopaper . The sample site was gently air-dried and all supragingival plaque was removed. The area was carefully isolated with cotton rolls and a saliva ejector was used to prevent the samples from being contaminated by saliva. The paper strips were inserted into the pockets until slight resistance was felt and left in place for 30s.
15984269|NCT03005886|Procedure|phase I therapy|comprehensive proper plaque control program, scaling, subgingival curettage and root Phase I Periodontal Therapy planning
15984270|NCT03005873|Drug|TLC599 LD group|Single dose via intra-articular injection
15984271|NCT03005873|Drug|Normal Saline|Single dose via intra-articular injection
15984272|NCT03005873|Drug|TLC599 HD group|Single dose via intra-articular injection
15984273|NCT03005860|Drug|2,6-Diisopropylphenol|In Propofol group, anesthesia will be induced with Propofol TCI using Schneider model to achieve a target site concentration of 4 - 6 mcg/ml. Propofol TCI to achieve BIS (Bispectral Index) between 40-60.
15984274|NCT03005860|Drug|Fluoromethyl hexafluoroisopropyl ether|In Sevoflurane group, anesthesia will be induced with 5 - 7mg/kg thiopental, maintenance with O2 with air 50:50%, sevoflurane 2-2.5 %, Further fentanyl, in increments of 1 mcg/kg - and atracurium 0.15 mg/kg, will be given as indicated by the clinical signs and hemodynamic changes.
15984275|NCT03005860|Drug|Fentanyl Citrate|Inj. fentanyl 2 mcg/kg will be used as an adjunct during anaesthetic induction.
15984276|NCT03005860|Drug|Atracurium Besylate|Inj. atracurium 0.5 mg/kg for will be administered for facilitating LMA placement
15984277|NCT03005847|Dietary Supplement|fermented papaya preparation|dietary supplementation with fermented papaya preparation
15984278|NCT03005834|Other|incidence of cancers|With a continuous surveillance system to track all subsequent incidents of CVD and/or non-CVD via direct contact in the outpatient department, hospital records, and a mailed questionnaire at least once a year, an incidence of cancers was identified.
15984279|NCT03005821|Other|Chinese pediatric massage therapy + usual care|
15984280|NCT03005821|Other|Sham massage therapy + usual care|
15984281|NCT03005808|Drug|Ropivacaine|Surgery for appendicitis
15984282|NCT03005795|Device|Headphones|Music can be heard through headphones
15984283|NCT03005795|Other|No Headphones|No Headphones will be used.
15984284|NCT03005782|Drug|REGN3767|
15984285|NCT03005782|Drug|cemiplimab|
15984286|NCT03005756|Device|Needle guiding robot|This intervention is to evaluate the safety and efficacy of a needle guiding robot for assisting targeting in CT-guided radiofrequency ablation of hepatocelluar carcinomas.
15984287|NCT03005743|Radiation|Magnetic Resonance Image based Brachytherapy|MRI based BT prescription will be in accordance to the GEC-ESTRO guidelines [Intention will be to treat the whole cervix and the remaining residual tumour tissue at the primary site at the time of BT (high risk-clinical target volume) to a dose level analogue to the dose level previously prescribed for point-A]
15984288|NCT03005743|Radiation|Conventional Radiograph based Brachytherapy|The standard conventional radiography based prescription will be according to Manchester system Point A and bladder & rectum ICRU point dose constraints
15984289|NCT03005730|Other|phototherapy|The portable PainAway® nine-diode cluster (Multi Radiance Medical®, Solon, OH, USA) will be employed. This system has one 905 nm laser diode, four 875 nm LED diodes and four 670 nm LED diodes. The aperture size of device is 4 cm2.
15984290|NCT03005730|Other|phototherapy placebo|The placebo portable. The aperture size of device is 4 cm2 .
15984291|NCT03005717|Drug|LIPO-202|
15984292|NCT03005717|Drug|Placebo for LIPO-202|Lyophile manufactured to mimic LIPO-202 lyophile.
15984293|NCT03005704|Drug|Antiplatelet treatment|Subjects will be treated with ticagrelor in combination with acetylsalicylic acid for five days. Ticagrelor will be administered at a loading dose of 180 mg, followed by 90 mg twice daily maintenance dose. Acetylsalicylic acid will be administered at a dose of 81 mg daily.
15984294|NCT03005691|Radiation|Spectroscopy|"Spectroscopy is a noninvasive method to assess brain chemistry. The signal of the hydrogen atom attached to a certain molecule or metabolite has a particular frequency associated with a given metabolite. The utility of Spectroscopy is based on the fact thet the nuclei of atoms have magnetic properties that can be used to obtain chemical information regarding both the type of molecule and it is concentration.
~The subjects will be scanned on a 3-T Siemens system and an 12-channel phased-array coil will be used to provide an optimum signal-to-noise ratio for spectroscopy data."
15984295|NCT03005691|Other|Questionnaires|Questionnaires are important to assess the chronic pain and their impact in the quality of life. For this reason, we will assess the Brief Pain Inventory (BPI), it is used to evaluate the subject's perception of pain severity and its interference. Moreover, we will assess neuropathic pain symptoms with the NPSI to detect paresthesia/dysaesthesia, evoked pain and paroxysmal pain. The catastrophizing score will be measured with the Pain Catastrophizing Helplessness Subscale. Also,we will assess the disability after whiplash using the Neck Disability Index.
15984296|NCT03005691|Procedure|Conditioned Pain Modulation|Conditioned Pain Modulation over the tenar eminence. The test will be a heat tonic stimulus which evoke a 3-pain intensity. The conditioning stimulus will be a cold water immersion (12ºC)
15984297|NCT03005678|Drug|Denosumab|active treatment group
15984298|NCT03005678|Drug|Alendronate|comparator
15984299|NCT03005665|Drug|Acetazolamide|
15984300|NCT03005665|Drug|Normal Saline|
15984301|NCT03005652|Behavioral|Mindfulness weekly courses for 8 weeks|The mindfulness intervention combines intensive training in mindfulness and compassion meditations, light movement and yoga activities, and psycho-educational components to promote nonjudgmental awareness of present moment experiences.
15984302|NCT03005652|Behavioral|Health education weekly courses for 8 weeks|The health education intervention is group-based programme has been developed and validated in an SCD population. Each session of the course covers different subjects, which include self-management, problem-solving, sleep, stress, exercise, managing medicines and memory, communicating with healthcare professionals, eating, and planning for the future.
15984303|NCT03005639|Drug|Vemurafenib and Cobimetinib|All participants will receive study treatment for up to 56 days (8 weeks). After completing treatment, they will undergo a lymph node removal surgery. After surgery, they will have follow-up visit 2-4 weeks after surgery.
15984304|NCT03005626|Other|Therapeutic education|
15984305|NCT03005626|Other|Standard follow-up|
15984306|NCT03005613|Procedure|ischial spine fascia fixation|The participants will receive ischial spine fascia fixation.
15984307|NCT03005613|Procedure|sacrospinous ligament fixation|The participants will receive sacrospinous ligament fixation.
15984308|NCT03005574|Behavioral|TSW-HP|TSW-HP involves home practice of cognitive exercises along with the training sessions facilitated by the cognitive specialist at the agency.
15984309|NCT03005574|Behavioral|TSW-T|Participants assigned to traditional TSW will receive the usual TSW program which includes a one hour session per week at BCS for 6 months. This group will not receive home based cognitive practice exercises
15984310|NCT03005561|Behavioral|Play Back Sessions|"100 participants that will be participating in two Play Back meetings. Playback define that improvisation as a theater facilitator asks the audience to share moments, feelings and stories of his daily life, and a group of actors improvise their stories in front of the stage as a kind of play-back. Unlike hobbies such as sports or singing, the method allows not only to unload the tensions but also communication and collaboration. It is very reminiscent of psychodrama, but unlike, is not considered a therapeutic tool."
15984311|NCT03005548|Device|Transcranial direct current stimulation|"Transcranial direct current stimulation. All eligible patients will be treated with patient-controlled IV morphine analgesia by PCA (PCA pump (CADD-Legacy PCA Pump, Deltec, Inc.) IV morphine bolus 1 mg, lockout time 10 mins.).
~Device: wireless tDCS (StarStim, NeuroElectrics) non-invasive brain stimulation with a pair of electrodes with saline-soaked pads for delivery of direct current at intensity 2 mA for 20 mins."
15984312|NCT03005548|Drug|Morphine|"In Sham comparator group All eligible patients will be treated with patient-controlled IV morphine analgesia (PCA) (PCA pump (CADD-Legacy PCA Pump (Deltec, Inc.) morphine IV bolus 1 mg, lockout time 10 mins).
~Device: wireless tDCS (StarStim, NeuroElectrics) non-invasive brain stimulation with a pair of electrodes with saline-soaked pads for delivery of direct current at intensity 2 mA for 30s at the beginning."
15984313|NCT03005535|Other|Vitaminized corn oil|Oil consumption at the two main meals, lunch and dinner (15gx2 per day)
15984314|NCT03005535|Other|Olive oil|Oil consumption at the two main meals, lunch and dinner (15gx2 per day)
15984315|NCT03005522|Drug|oral dexamethasone|Patient will be dosed with either placebo or with the study drug, 10mg oral dexamethasone, to be administered by mouth one time in the ED
15984316|NCT03005522|Drug|Placebo Oral Capsule|dosed with placebo
15984390|NCT03005041|Other|Bottled mineral water|Participants will rinse their mouth with 15 mL of the water swishing for 30 seconds.
15984391|NCT03005015|Drug|Lenvatinib|
15984392|NCT03005015|Drug|Doxorubicin|
15984393|NCT03005002|Biological|Durvalumab|Given IV
15984317|NCT03005509|Other|TQIM checklist|"The intervention phase will include an intense training period covering:
~Conduct of Trauma Quality Improvement Meeting (TQIM) (and Trauma Quality Improvement program in general). The training will be delivered using the World Health Organization (WHO) Trauma Quality Improvement Programmes short course and online resources.
~Implementation of Trauma Quality Improvement Meeting (TQIM) Checklist."
15984318|NCT03005496|Drug|Zinc|included in intervention arm
15984319|NCT03005496|Drug|Nifedipine|included in intervention and control arm
15984320|NCT03005496|Drug|Beta Carotene|included in intervention arm
15984321|NCT03005496|Drug|Vitamin D3|included in intervention arm
15984322|NCT03005496|Drug|Dexamethasone|included in intervention and control arm
15984323|NCT03005483|Drug|Gabapentin|Orthopedic Surgery was applied for the treatment of osseous disorders
15984324|NCT03005483|Other|Placebo|Orthopedic Surgery was applied for the treatment of osseous disorders
15984325|NCT03005470|Device|TELEM|Participants in the telemonitoring home blood pressure (TELEM) group will receive an oscillometric monitor to measure blood pressure at home for six months. Measurements will be made early in the morning (5:00 to 10:00) and in the evening (18:00 to 21:00) for at least five days a week (including one day during the weekend). Each blood pressure measure will be sent to the center of the study coordination center through software downloaded on the participant's smartphone.
15984326|NCT03005470|Device|TELEMEV|In the lifestyle telemonitoring group (TELEMEV), participants will receive customized standardized text messages to stimulate lifestyle changes and adherence to blood pressure lowering medication. The messages will be focused on the adoption of DASH diet, sodium restriction, increase of physical activity, weight control and adherence to drug treatment. They will be sent out on four of the five days of the week at random times. The messages will be sent to the smarphones through a software developed for this study.
15984327|NCT03005470|Device|TELEM-TELEMEV|Participants in the TELEM plus TELEMEV (TELEM-TELEMEV) will receive both interventions as previously described.
15984328|NCT03005470|Other|UCT|Participants in the control group will receive usual clinical treatment (UCT) on pre-scheduled visits, but will not receive any technological tool to stimulate blood pressure control or lifestyle modification.
15984329|NCT03005457|Behavioral|Hemiparesis Therapy with VR|An in-home therapist-as-consultant model of CI therapy in which motor practice with shaping and the Motor Activity Log with problem solving were delivered via a custom avatar-based video game called Recovery Rapids
15984330|NCT03005444|Drug|Rivaroxaban|10mg/day, for 2 years
15984331|NCT03005431|Behavioral|Parent training and support|Parents will be given access to participate in an on-line support forum and a set of on-line parent training modules.
15984332|NCT03005418|Biological|Human Acellular Vessel (HAV)|The investigational medicinal product (IMP) is a Humacyte Human Acellular Vessel (HAV), which is a tissue-engineered vascular prosthesis for arterial bypass or reconstruction in patients with peripheral arterial disease or peripheral arterial trauma. It is a sterile, non-pyrogenic acellular tubular vessel composed of human collagen types I and III and other extracellular matrix proteins, including fibronectin and vitronectin. The vessel is 6 mm in diameter and approximately 42 cm in length. The product is supplied on a silicone mandrel immersed in sterile phosphate buffered saline in a sealed and labeled plastic container. The Humacyte HAV is implanted using standard vascular surgical techniques similar to placement of predicate peripheral vascular prostheses.
15984333|NCT03005405|Procedure|Ionomer Restoration (control)|Restoration of moderate caries lesions after partial caries removal using high viscosity glass ionomer cements
15984334|NCT03005405|Procedure|Ionomer Sealant (test)|Sealing of moderate caries lesions without any caries removal or cavity opening.
15984335|NCT03005405|Procedure|Oral hygiene orientation and professional fluoride application|Oral hygiene orientation and professional fluoride application
15984336|NCT03005392|Other|exercise|"An exercise program will be designed over 16 weeks with 55 sessions, moderately increasing the volume and intensity of the load every 4 weeks. The program will consist of strength exercises, flexibility and aerobic endurance, which will be explained in videos and are going to be available in an online platform.
~The physiotherapist will contact the patient and/or tutor weekly so as to answer and doubts they may have with respect to the exercise program and to further supervise their compliance (group with intervention)."
15984337|NCT03005379|Drug|Fecal Microbiota Therapy (FMT)|Oral capsule-delivered FMT
15984338|NCT03005379|Drug|Placebo|Oral capsule-delivered placebo
15984339|NCT03005366|Drug|Vernakalant|Initial infusion: 3 mg/kg intravenously over a 10 minute period. For patients weighing ≥ 113 kg, the maximum initial dose will be 339 mg. If conversion to sinus rhythm does not occur within 15 minutes after the end of the initial infusion, a second 10 minute infusion of 2 mg/kg will be administered. For patients weighing ≥ 113 kg, the maximum second infusion will be 226 mg.
15984340|NCT03005366|Drug|Flecainide|2 mg /kg (max 150 mg) intravenously over 10 minutes.
15984341|NCT03005353|Drug|Cumin seed extract|patients will receive the drug in suppository form
15984342|NCT03005353|Drug|clotrimazole|patients will receive the drug in suppository form
15984343|NCT03005340|Drug|Treatment B|Bazedoxifene 20 mg
15984344|NCT03005340|Drug|Treatment C|Cholecalciferol granule 10 mg
15984345|NCT03005340|Drug|Treatment BC|Bazedoxifene 20 mg, Cholecalciferol granule 10 mg
15984346|NCT03005327|Drug|X4P-001|Mavorixafor will be provided as either 25 mg or 100 mg capsules.
15984347|NCT03005314|Procedure|chemotherapy|chemotherapy before surgery
15984348|NCT03005314|Procedure|Surgery|chemotherapy after surgery
15984349|NCT03005301|Device|intelligent electroacupuncture instrument|"Choice of major points: GB20, GB21, EX-B2, GV14. Choice of adjunct points based on syndrome differentiation.
~Trial instrument of this study is the CX-DZ-Ⅱ type intelligent electroacupuncture therapeutic instrument.Choice of acupuncture needle: one-off stainless acupuncture needle, which is 25~40mm in length and 0.30~0,38mm in diameter.Waveform: continuous-wave with frequency of 120~250 times per minute and current intensity within patients' tolerance.Treatment time: each treatment time is 30 minutes."
15984350|NCT03005301|Device|Hwato electroacupuncture instrument|"Choice of major points: GB20, GB21, EX-B2, GV14. Choice of adjunct points based on syndrome differentiation.
~The Hwato electroacupuncture treatment instrument. Waveform: continuous-wave with frequency of 120~250 times per minute and current intensity within patients' tolerance.
~Treatment time: each treatment time is 30 minutes."
15984351|NCT03005288|Drug|BYM338 10 mg/kg|intravenous infusion every four weeks
15984353|NCT03005275|Other|IVM|"FSH injection: Day 9, 10 and 11 (can be adjusted 1-3 days before or after to avoid Ultrasound and OPU on holidays). Dose: normally 100 IU/day (maybe 75 - 150 IU/day).
~Follicle and endometrium can be evaluated: on the day of final injection or one day later.
~hCG 10.000 IU: one day after the final FSH injection, at 9 p.m. Can be adjusted HCG injection day (± 1-2 days) to avoid Ultrasound and OPU on vacation.
~OPU: 1,5 day after hCG injection (normally 36-42 hours later). Sperm collection: on OPU day (if mature follicle presents) or 1 day after OPU day.
~Embryo transfer: 3 days after OPU. Luteal support: progesterone gel (90 mg once daily) intra-vaginally and estradiol (4 mg/day PO, twice daily) initiated on the day of OPU or the day thereafter."
15984354|NCT03005275|Other|ICSI|"Daily SC injections with rFSH (minimum starting dose is around 150 IUI) are started on On day 2 or day 3 of the menstrual cycle (Stimulation Day 1) and continue up to and including Stimulation Day 7.
~From Stimulation Day 8 onwards, subjects from ICSI treatment groups will continue with a daily SC dose of rFSH up to the day before GnRH agonist day. The maximum rFSH dose to continue treatment after the first 7 days is 300 IU but the dose could be adjusted when desired.
~As soon as three follicles of 17mm are observed by USS at least, a GnRH agonist (Triptorelin 0.2 mg) will be used for final oocyte maturation at the same day. About 34-36 h thereafter, OPU followed by ICSI is performed. Two days after oocyte pick-up 2 fresh embryos will be transferred"
15984355|NCT03005262|Drug|MLN8237|
15984356|NCT03005249|Procedure|neural stem cells therapy group|The patients will be assigned to neural stem cells therapy group for cerebral palsy.
15984357|NCT03005249|Other|the control group|The patients will be assigned to the control group for cerebral palsy.
15984358|NCT03005236|Drug|ENVARSUS|Envarsus is a once-a-day oral formulation of tacrolimus.
15984359|NCT03005236|Drug|Standard twice daily tacrolimus|Standard tacrolimus will include twice-daily formulations that are currently available.
15984360|NCT03005223|Drug|Co-administration of DWC20155/DWC20156|
15984361|NCT03005223|Drug|DWC20163|
15984362|NCT03005210|Drug|Magicbuvir Plus|1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir
15984363|NCT03005210|Drug|Harvoni (fist dose)|1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir
15984364|NCT03005210|Drug|Harvoni (second dose)|1 tablet contains 400 mg Sofosbuvir and 90 mg Ledipasvir
15984365|NCT03005197|Device|Laser Doppler Flowmetry|
15984366|NCT03005184|Drug|Valsartan 80 mg bid|oral medication during run-in and washout period
15984367|NCT03005184|Drug|Enalapril 10 mg bid|oral medication
15984368|NCT03005184|Drug|Sacubitril-Valsartan 200 mg bid|oral medication
15984369|NCT03005184|Drug|Icatibant|intravenous medication
15984370|NCT03005184|Drug|Placebo|intravenous medication
15984371|NCT03005171|Drug|Bupivacaine|Thoracic epidural bupivacaine infusion
15984372|NCT03005171|Drug|Lidocaine|Intravenous lidocaine infusion
15984373|NCT03005158|Other|Validation Phase|Standard care across all sites during the validation phase will rule out myocardial infarction in those with presentation troponin below the 99th centile with greater than 6 hours of symptoms at the time of blood sampling. In those with less than 6 hours of symptoms, a second test will be measured 6- 12 hours after presentation.
15984374|NCT03005158|Other|Randomization Phase|Standard care or HighSTEACS pathway.
15984375|NCT03005158|Other|Implementation Phase|Implementation of the HighSTEACS pathway to rule out myocardial infarction in patients with suspected acute coronary syndrome. Myocardial infarction will be ruled out if presentation cardiac troponin concentrations are <5 ng/L in those with at least 2 hours of symptoms at the time of blood sampling. In patients with less than two hours of symptoms, or where cardiac troponin concentrations are between 5ng/L and the 99th centile, repeat testing will be recommended at 3 hours. Myocardial infarction will be ruled out at 3 hours if cardiac troponin concentrations are unchanged (<3 ng/L change) and remain ≤99th centile on retesting. Those remaining ≤99th centile on retesting but demonstrating a significant change will require admission for further testing at 6-12 hours.
15984376|NCT03005145|Other|7 days of adequate antibiotic treatment|The choice of treatment including type, dose, route and interval of antibiotic will be left at the discretion of treating team as long as it is appropriate for the bacteremia
15984377|NCT03005145|Other|14 days of adequate antibiotic treatment.|The choice of treatment including type, dose, route and interval of antibiotic will be left at the discretion of treating team as long as it is appropriate for the bacteremia
15984378|NCT03005132|Other|Normal brain tissue|The investigators will extract total protein, DNA and RNA from the samples.
15984379|NCT03005119|Drug|PTL201|Two piece acid resistance hard capsule filled with seamless gelatin matrix green beads containing tetrahydrocannabinol (THC) and cannabidiol (CBD). Each capsule contain 5 mg THC and 5 mg CBD
15984380|NCT03005119|Drug|Placebo Oral Capsule|Placebo seamless gelatin matrix green beads containing excipients only
15984381|NCT03005106|Biological|StrataGraft Skin Tissue|StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).
15984382|NCT03005106|Procedure|Autograft|The current standard of care procedure for the treatment of severe burns. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original burn wound.
15984383|NCT03005093|Other|CAREGIVERS|The Turkish Feeding/Swallowing Impact Survey will be completed by the caregivers
15984384|NCT03005093|Other|CHILDREN OF CAREGIVERS|Chewing performance with Karaduman Chewing Performance Scale, tongue control with Tongue Thrust Rating Scale, dysphagia symptom severity with the Pediatric version of the Eating Assessment Tool will be evaluated. These assessments will be done before and after swallowing rehabilitation program.
15984385|NCT03005067|Drug|Carbomer 980 (1146A)|Test product containing carbomer 980 gel
15984386|NCT03005067|Other|Placebo|Reference product containing vehicle without carbomer 980 gel
15984387|NCT03005054|Biological|StrataGraft Skin Tissue|StrataGraft® skin tissue is provided as a suturable rectangular piece of stratified epithelial tissue composed of a living dermal matrix containing dermal fibroblasts overlaid with human epidermal keratinocytes (NIKS®).
15984388|NCT03005054|Procedure|Autograft|The current standard of care procedure for the treatment of severe complex skin defects. The procedure involves the removal of a sheet of healthy skin from an uninjured site on the patient and using it to cover the original wound.
15984394|NCT03005002|Other|Laboratory Biomarker Analysis|Correlative studies
15984396|NCT03004989|Behavioral|Programme|The participants of this study had participated in one of three different RTW-GPs. These programmes are designed to enable participants to proactively take action in their daily lives and in collaboration with employers achieve the best possible working conditions. All the group sessions are based on cognitive theory where attention, awareness and reflection on one's own work and life situation is important
15984397|NCT03004976|Biological|Umbilical Cord Blood|Umbilical cord blood will be infused intravenously through a peripheral IV line after premedication with diphenhydramine, hydrocortisone, and acetaminophen. Units will be from a public cord blood bank with selection based on blood type, race, and the number of cells in the pre cryopreservation product, targeting a dose range of 0.5 to 5 x 10^7 TNCC/kg.
15984398|NCT03004976|Other|Placebo|The placebo product will be acellular and will consist of tissue culture medium 199 (TC-199 [pink]) with 1% dimethyl sulfoxide (DMSO), which are standard components in cellular products. The volume of placebo product will be 50 mL, which is in the range of a typical UCB unit that has been washed and thawed after cryopreservation. Infusion and premedication procedures will be the same as those conducted for the umbilical cord blood arm.
15984399|NCT03004963|Device|Body composition monitor|Both body composition monitor (BCM) is used to evaluate the volume status of patients.
15984400|NCT03004963|Device|clinical indexes|The investigators evaluate the volume status of patients according to clinical indexes.
15984401|NCT03004937|Other|Family Medicine Hearing Loss Best Practice Alert|A Best Practice Alert, or BPA, was created in the electronic medical record system, which fires when patients meet the inclusion criteria. It reminds providers to ask their patients if they think have a hearing loss and allows them to respond as needed (refer to audiology, add hearing loss to the problem summary list, or dismiss for one year).
15984402|NCT03004924|Drug|SHP640|Instill 1 drop of SHP640 (povidone-iodine [PVPI] 0.6% and Dexamethasone 0.1%) ophthalmic suspension in each eye QID (with a minimum of 2 hours between doses) for 7 days.
15984403|NCT03004924|Drug|PVP-I 0.6%|Instill 1 drop of PVP-I 0.6% ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days.
15984404|NCT03004924|Drug|Placebo|Instill 1 drop of placebo ophthalmic solution in each eye 4 times QID (with a minimum of 2 hours between doses) for 7 days.
15984405|NCT03004911|Device|ProFibro (Mobile application)|ProFibro, a mobile Android application in Brazilian Portuguese to promote self-care in patients with fibromyalgia
15984406|NCT03004911|Device|Paper booklet|A 64-page booklet with content similar to the mobile application
15984407|NCT03004898|Behavioral|multidisciplinary renal education|multidisciplinary CKD care involving case management nurse, dietitian, social worker, pharmacists.
15984408|NCT03004885|Device|PrismaLung|Low flow Extracorporeal CO2 removal using a 0.32 m² membrane oxygenator
15984409|NCT03004846|Drug|GSK2981278 ointment|"GSK2981278 ointment will be applied topically twice daily for 8 weeks to all subjects in Part A and to randomized subjects in Part B. GSK2981278 will be a white to off-white ointment and a thin layer will be applied to all affected areas for given timeframe.
~GSK2981278 is available as white to off-white ointment in unit strength 4% (w/w), 2% (w/w) and 0.8% (w/w), for topical application for application as thin layer to all affected areas ."
15984410|NCT03004846|Drug|Vehicle ointment|It will be supplied as white to off-white vehicle ointment for topical application.
15984411|NCT03004833|Drug|Nivolumab|Infusion of Nivolumab
15984412|NCT03004833|Drug|Adriamycin|Infusion of Adriamycin
15984413|NCT03004833|Drug|Vinblastine|Infusion of Vinblastine
15984414|NCT03004833|Drug|Dacarbazine|Infusion of Dacarbazine
15984415|NCT03004820|Device|Remote Ischemic Conditioning|RIC consist of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on bilateral upper limbs twice a day. Medication strategy is based on physician's best judgement.
15984416|NCT03004807|Dietary Supplement|Centrum Silver Mens' Formula|Multivitamin/Multimineral dietary supplement produced for Pfizer for use in older men.
15984417|NCT03004807|Other|Control|A matching tablet to the dietary supplement, but without any active ingredients
15984418|NCT03004794|Other|medical records review|
15984419|NCT03004781|Behavioral|Parenting program|
15984420|NCT03004768|Drug|BMS-986165|Oral solution dose of 24 mg [14C] BMS-986165 containing approximately 100 micro Ci of TRA
15984421|NCT03004755|Other|Tissue Harvest|
15984422|NCT03004742|Dietary Supplement|Flavonoid|Flavonoid rich supplement
15984423|NCT03004742|Dietary Supplement|Placebo|Placebo
15984424|NCT03004729|Other|CoMiSS questionnaire|
15984425|NCT03004716|Other|Aerobic training|"5 consecutive patients with chronicle obstructive pulmonary disease are offered to participate in the protocol when they have reached 45 min of aerobic training during their pulmonary rehabilitation program.
~During 5 sessions of 45 min, they are monitored with an oximeter device (Nonin 3150) which records heart rate (HR) and oxygen transcutaneous saturation (SpO2). The device also communicates with a telemedicine medical gateway which sends these data to a remote telemedicine center. Data are then provided on a secured online platform and compared with data recorded on the device (Nonin 3150)."
15984426|NCT03004703|Drug|Tocilizumab|Active drug: Tocilizumab, 20 mg/ml; 14 ml (280 mg) dissolved in 100 ml NaCl 0.9 % i.v. once.
15984427|NCT03004703|Drug|Sodium chloride 0.9%|Placebo: Sodium chloride 0.9%; 100 ml i.v. once.
15984428|NCT03004690|Device|PPE Suit A|In this randomized study following good clinical practice guidelines nineteen study volunteers were recruited to wear one of two different types of randomly allocated PPE suits. Suit A has to be used by randomly selected participants to perform four different tests six times at 22°C on one day and four times at 28°C on another day in the local core facility clinical research center.
15984429|NCT03004690|Device|PPE Suit B|Suit B has to be used by randomly selected participants to perform four different tests six times at 22°C on one day and four times at 28°C on another day in the local core facility clinical research center.
15984430|NCT03004677|Behavioral|Continuous skin-to-skin contact|Infants will rest in skin-to-skin contact on parents' chest 24 hours a day alternating between the parents. The parents will note who provides the SSC and if and for how long they are off SSC for any reason.
15984431|NCT03004677|Other|Standard Care|Infants will receive regular care in the NICU. Parents may practice SSC if they like. Parents will note if, with whom, and for how long they provide SSC.
15984598|NCT03003715|Procedure|transcranial direct current stimulation (tDCS)|In active tDCS, a 2 milli-amp transcranial direct current stimulation is for 20 minutes.
15984432|NCT03004664|Behavioral|Support Empowerment Model|The DSMS combines a series of clinically informed group didactic sessions that use a patient self-determination approach to empower patients to take control of their own diabetes health with follow-up supports to sustain self-management gains achieved during the sessions.
15984433|NCT03004664|Behavioral|The Chronic Care Model|the CCM focuses on addressing social determinants of health by meeting the medical, cultural, and linguistic needs of patients through integration of cultural norms and social relationships from the patient population into program design
15984434|NCT03004651|Other|Power Doppler ultrasound|Mesure of synovitis (≥ grade 1 synovitis on a semi-quantitative scale)
15984435|NCT03004651|Other|Clinical evaluation|swollen joint count (SJC) as componant of SDAI
15984436|NCT03004638|Drug|MEDI6012 40 mg|Participants received 3 doses of 40 milligram (mg) MEDI6012 IV on Days 1, 8, and 15.
15984437|NCT03004638|Drug|Placebo|Participants received 3 doses of placebo matching with MEDI6012 intravenously (IV) on Days 1, 8, and 15.
15984438|NCT03004638|Drug|MEDI6012 120 mg|Participants received 3 doses of 120 mg MEDI6012 IV on Days 1, 8, and 15.
15984439|NCT03004638|Drug|MEDI6012 300 mg|Participants received 3 doses of 300 mg MEDI6012 IV on Days 1, 8, and 15.
15984440|NCT03004638|Drug|Placebo IV Push|Participants received 3 doses of placebo matching with MEDI6012 by IV push. A loading dose on Day 1 and maintenance doses on Days 3 and 10.
15984441|NCT03004638|Drug|MEDI6012 IV Push|Participants received 3 doses of MEDI6012 by IV push as 300 mg loading dose on Day 1, and maintenance doses of 150 mg and 100 mg on Day 3 and Day 10, respectively.
15984442|NCT03004625|Drug|daclatasvir|to evaluate the treatment efficacy and safety of the drug in HCV patients
15984443|NCT03004625|Drug|asunaprevir|to evaluate the treatment efficacy and safety of the drug in HCV patients
15984444|NCT03004625|Drug|Ribavirin|to evaluate the treatment efficacy and safety of the drug in HCV patients
15984445|NCT03004612|Combination Product|Linagliptin + metformin|Linagliptin-Metformin 2.5/850mg twice daily plus a lifestyle modification program based on nutritional assesment, physical activity prescription and general counseling
15984446|NCT03004612|Drug|Metformin|Metformin 850mg twice daily plus a lifestyle modification program based on nutritional assesment, physical activity prescription and general counseling
15984447|NCT03004599|Device|SYM-SV-002 Aortic Bioprosthesis and SYM-DS-002 Transfemoral Delivery System|Transcatheter Aortic Valve Implantation via Transfemoral Approach
15984448|NCT03004586|Device|25-Gauge Needle|Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by using a 25-gauge needle.
15984449|NCT03004586|Device|22-Gauge Needle|Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed by using a 25-gauge needle.
15984450|NCT03004586|Procedure|Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration (EBUS-TBNA)|Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed.
15984451|NCT03004573|Other|Neuropsychological detailed tests with focus on social cognition|MATTIS, MOCA, BREF, Light points test, PDQ39
15984452|NCT03004560|Procedure|Standard Laparoscopic Approach|Minimally invasive laparoscopic surgery with 5-10 mm incisions.
15984453|NCT03004560|Procedure|Percutaneous Approach|Minimally invasive laparoscopic surgery with 2-3 mm incisions.
15984454|NCT03004547|Other|Measuring sodium content|Sodium MRI measurement of sodium content in the tissues of all participants
15984455|NCT03004534|Drug|darolutamide|Oral 300 mg tablets; 600 mg (2 x 300 mg tablets) taken twice per day, to a daily dose of 1200 mg.
15984456|NCT03004521|Drug|Quetiapine|Quetipatine prescribed in addition to the patient's existing antidepressant treatment.
15984457|NCT03004521|Drug|Lithium|Lithium prescribed in addition to the patient's existing antidepressant treatment.
15984458|NCT03004508|Dietary Supplement|Gingko Biloba Extract|120mg/day, twice a day, 6 month
15984459|NCT03004508|Dietary Supplement|Placebo|120mg/day, twice a day, 6 month
15984460|NCT03004495|Drug|CHF5259 and CHF6001|b.i.d. for 14 days
15984461|NCT03004495|Drug|CHF5259 + placebo|b.i.d. for 14 days
15984462|NCT03004495|Drug|CHF6001 + placebo|b.i.d. for 14 days
15984463|NCT03004495|Other|Placebo|b.i.d. for 14 days
15984464|NCT03004469|Drug|P-3074|
15984465|NCT03004469|Drug|Finasteride|
15984466|NCT03004469|Drug|P-3074 Vehicle|
15984467|NCT03004469|Drug|Finasteride Placebo|
15984468|NCT03004456|Other|Distraction|Distraction will be provided by allowing the patient to will choose an age appropriate application (e.g. movie, game) which will be held for them during the blood draw.
15984469|NCT03004443|Drug|Infliximab|Infliximab will be administered intravenously (IV) as 5 mg/kg body weight over a 2 to 2.5 hour period.
15984470|NCT03004443|Drug|Placebo|Saline solution will be administered intravenously over a 2 to 2.5 hour period.
15984471|NCT03004430|Behavioral|Mantra Meditation|Silent mantra meditation with spiritual mantra
15984472|NCT03004430|Behavioral|Progressive Muscle Relaxation|Progressive Muscle Relaxation
15984473|NCT03004417|Drug|CHF 6001 Dose1|CHF 6001 plus placebo
15984474|NCT03004417|Drug|CHF 6001 Dose2|CHF 6001 only (high dose)
15984475|NCT03004417|Other|Placebo|Placebo only
15984476|NCT03004404|Drug|Placebo|
15984477|NCT03004404|Drug|BI 730357|
15984478|NCT03004378|Behavioral|Activity Tracker|Fitbit Alta
15984479|NCT03004365|Drug|27.2 mg C16G2 Varnish|Antimicrobial Peptide
15984480|NCT03004365|Drug|13.6 mg C16G2 Varnish|Antimicrobial Peptide
15984481|NCT03004365|Drug|54.4 mg C16G2 Varnish|Antimicrobial Peptide
15984482|NCT03004365|Drug|Placebo Varnish|Placebo
15984483|NCT03004352|Other|retrograde flow|Two pneumatic cuffs were placed on the experimental arm, one on the lower forearm, and the other on the upper arm. Two cuffs were simultaneously inflated for 20 minutes. The distal cuff was inflated to 75 mm Hg and the proximal cuff was inflated to 40 mm Hg. The contralateral (control) arm was cuff free during this intervention.
15984484|NCT03004352|Other|oxygen|Supplemental 100% oxygen administered through a nasal cannula.
15984485|NCT03004339|Drug|SOR007 Ointment 2.0%|
15984486|NCT03004339|Drug|SOR007 Ointment 1.0%|
15984487|NCT03004339|Drug|SOR007 Ointment 0.3%|
15984488|NCT03004339|Drug|SOR007 Ointment 0.15%|
15984489|NCT03004339|Drug|SOR007 Ointment Placebo|
15984496|NCT03004287|Drug|Carfilzomib|Given by vein: days 1 and 2 of Induction; days 1, 8, 15, and 22 of Consolidation 1; and days 1, 8, 15, and 22 of alternating 3-month blocks during Maintenance.
15984497|NCT03004287|Drug|Thalidomide|Given by mouth at bedtime: days 1-4 of Induction
15984498|NCT03004287|Drug|Dexamethasone|Given by mouth or by vein: days 1-4 of Induction; days -4 - -1 of Transplant(s); and days 1, 8, 15, and 22 of every cycle during Maintenance
15984499|NCT03004287|Drug|Daratumumab|Given by vein: day -1 of induction; days 1 and 8 of Immunological Consolidations; and day 1 of each Maintenance cycle
15984500|NCT03004287|Drug|Cisplatin|Given by vein: days 1-4 (continuous infusion) of Induction
15984501|NCT03004287|Drug|Adriamycin|Given by vein: days 1-4 (continuous infusion) of Induction
15984502|NCT03004287|Drug|Cyclophosphamide|Given by vein: days 1-4 (continuous infusion) of Induction
15984503|NCT03004287|Drug|Etoposide|Given by vein: days 1-4 (continuous infusion) of Induction
15984504|NCT03004287|Drug|Melphalan|Given by vein: days -4 - -1 of Transplant(s)
15984505|NCT03004287|Procedure|ASCT|day 0 of Transplant(s)
15984506|NCT03004287|Drug|Lenalidomide|Given by mouth: days 1-21 of alternating 3-month blocks during Maintenance
15984507|NCT03004287|Drug|Bortezomib|Given by vein or subcutaneous injection: may be substituted for carfilzomib throughout the study regimen at the discretion of the treating physician
15984508|NCT03004274|Other|Running sutures|
15984509|NCT03004274|Other|Interrupted sutures|
15984510|NCT03004261|Biological|donor derived cytomegalovirus specific T lymphocytes|donor derived cytomegalovirus specific T lymphocytes will be transfused to recipients of hematopoietic stem cell transplant when they are sero-positive for CMV-DNA.
15984511|NCT03004261|Drug|Foscarnet|Foscarnet may be used for the treatment of CMV infection before and after the CMV-CTL infusion.
15984512|NCT03004261|Drug|Ganciclovir|Ganciclovir may be used for the treatment of CMV infection before and after CMV-CTL infusion.
15984513|NCT03004248|Biological|Botulinum Toxins, Type A|Intramuscular Injection
15984514|NCT03004235|Device|Observational data collection|Observational data collection
15984515|NCT03004222|Drug|Bupivacaine|20 ml of 0.5% Bupivacaine
15984516|NCT03004222|Drug|Placebos|
15984517|NCT03004209|Drug|Erythropoietin|three times per a week 100IU / k
15984518|NCT03004196|Drug|Probiotic Toothpaste|G.D Probiotic Toothpaste bacteriocin Lactic Acid Bacteria
15984519|NCT03004196|Drug|Dr. Reddy's Clohex|0.20% Chlorhexidine Mouthwash
15984520|NCT03004196|Other|Control Group|No Probiotic toothpaste & Chlorhexidine Mouthwash
15984521|NCT03004183|Biological|ADV/HSV-tk|Replication-defective recombinant adenovirus vector
15984522|NCT03004183|Drug|Valacyclovir|Prodrug of the antiviral drug acyclovir
15984523|NCT03004183|Radiation|SBRT|Low-dose SBRT
15984524|NCT03004183|Drug|Pembrolizumab|Humanized immunoglobulin G4 anti-programmed death-1 (PD-1) monoclonal antibody
15984525|NCT03004170|Behavioral|Telephone-Administered Motivational Interviewing Plus Behavioral Skills Training|
15984526|NCT03004170|Behavioral|Telephone-Administered Coping Effectiveness Training|
15984527|NCT03004157|Procedure|cardiopulmonary resuscitation|CPR for 10 minutes with a chest compression: ventilation ratio of 15:2 according to international CPR guidelines
15984528|NCT03004144|Other|FLOAT|
15984529|NCT03004131|Drug|Azelastine hydrochloride + fluticasone propionate nasal spray|
15984530|NCT03004131|Drug|Placebos|
15984531|NCT03004131|Drug|fluticasone propionate nasal spray + loratadine|
15984532|NCT03004118|Dietary Supplement|Nutridrink|Liquid meal of 200ml
15984533|NCT03004118|Device|High resolution manometry probe|Catheter inserted via the nose into the stomach to measure intragastric pressure.
15984534|NCT03004118|Device|perfusion catheter|Catheter inserted via the nose into the stomach to perfuse the nutridrink intragastricly.
15984535|NCT03004118|Drug|Placebo Oral Tablet|4 week oral intake (daily)
15984536|NCT03004118|Drug|Ursochol oral tablet|4 week oral intake (daily) (dose of 10.5mg/kg/day)
15984537|NCT03004118|Device|Duodenal fluid aspiration catheter|Catheter inserted via the nose into the duodenum to aspirate duodenal fluids for 2.5 hours.
15984538|NCT03004118|Procedure|Duodenogastroscopy|Catheter inserted via the mounth into the duodenum to take duodenal biopsies.
15984539|NCT03004118|Procedure|Blood sample|Blood sample will be taken to measure liver enzyme serum levels and marker for bile acid synthesis.
15984540|NCT03004105|Drug|Selumetinib|"Safety Run-In - Beginning dose is Selumetinib 50 mg by mouth twice a day on Days 1 through 28 of a 28 day cycle
~Intermittent Arm - Participants receive Selumetinib at 75 mg by mouth twice a day for 7 days on and 7 days off.
~Continuous Arm - Participants take Selumetinib twice daily on Days 1 to 28 of a 28 day cycle. Dose determined by safety run-in."
15984541|NCT03004105|Drug|Durvalumab|Safety Run-In, Intermittent Arm, Continuous Arm - Durvalumab 1500 mg by vein on Day 1 of a 28 day cycle.
15984542|NCT03004105|Behavioral|Phone Calls|About every 6 months, participant called by a member of the study staff to ask how participant is doing and if participant has started any new treatments outside of the study. These calls should last about 10 minutes each time.
15984543|NCT03004092|Procedure|blood sample|Twice weekly blood sample, and at every outpatient visit
15984544|NCT03004066|Drug|Daptomycin|standard care
15984545|NCT03004053|Device|Reflectance Confocal Microscopy (RCM) endoscope device|
15984546|NCT03004040|Biological|Flu Vaccine|
15984547|NCT03004027|Other|Self help leaflet|Self help leaflet entitled 'Building confidence in social situations: A guide for people living with a visible skin differences'
15984548|NCT03004014|Other|Sleep endoscopy during propofol induced sleep|It will be performed a sleep endoscopy during drug induced sleep endoscopy
15984549|NCT03004001|Drug|Alirocumab|150 mg biweekly
15984550|NCT03004001|Drug|Alirocumab placebo|placebo
15984551|NCT03004001|Drug|Atorvastatin|20 mg/day
15984552|NCT03003988|Dietary Supplement|Creatine monohydrate|Creatine monohydrate (6.0 g) + dextrose (0.5 g)
15984553|NCT03003988|Dietary Supplement|Creatine nitrate|Creatine nitrate (5.0 g creatine monohydrate + 1.5 g. creatine nitrate that provides 1.0 g. of creatine and 0.5 g. nitrate in 2:1 ratio)
15984554|NCT03003988|Dietary Supplement|Placebo|Placebo (6.5 g dextrose)
15984662|NCT03003260|Other|CBD chewing gum|
15984555|NCT03003975|Device|PVI by single cryoballoon application guided by Achieve Mapping Catheter|Pulmonary vein isolation by single cryoballoon application guided by recorded electrogram signals from an internal Mapping Catheter and by temperature drop if mapping of signals is not possible (temperature cutoff < or = -40 degrees C)
15984556|NCT03003975|Device|PVI by 2 routine cryoballoon applications|Pulmonary vein isolation by 2 cryoballoon applications guided by degree of occlusion and by temperature drop according to discretion of physician
15984563|NCT03003949|Drug|Estradiol Patch, 0.1 Mg/24 Hours Weekly Transdermal Film, Extended Release|Transdermal Estradiol worn daily for 16 weeks (patch changed every 7 days).
15984564|NCT03003949|Drug|Placebo Patch|Matching placebo patches to be worn every day for 16 weeks (patch changed every 7 days).
15984565|NCT03003949|Drug|Progesterone Capsule|Micronized progesterone (200 mg) will be administered every day for 12 days during the 9th week of randomization and again following randomization at the 17th week
15984566|NCT03003949|Drug|Placebo Oral Capsule|Matching placebo capsules will be administered orally every day for 12 days during the 9th week of randomization and again following randomization at the 17th week.
15984567|NCT03003936|Behavioral|Dinner timing|Glucose tolerance after a late diner (1 hour before habitual bedtime) differs from early dinner (4 hours before habitual bedtime) due to the concurrence of meal timing with different levels of endogenous melatonin. This effect can be different among risk allele carriers (G) or non-rick allele carriers (C) of the MTNR1B.
15984568|NCT03003923|Behavioral|Taste exposure|Exposure to the same vegetable
15984569|NCT03003923|Behavioral|Nutritional education|Eat Well and Strive for Five nutritional education
15984570|NCT03003910|Behavioral|Best Possible Self|Intervention group which requires people to envision themselves in a future in which all has gone in the best possible way.
15984571|NCT03003910|Behavioral|Daily Activities|Control group which consists of thinking and writing about all the activities and situations that had taken place during the last 24 h.
15984572|NCT03003897|Other|Soluble Fiber|Participants receiving soluble fiber.
15984573|NCT03003897|Other|Placebo|Participants receiving placebo.
15984574|NCT03003884|Drug|Remimazolam Tosilate|Initial dose plus supplemental doses as necessary.
15984575|NCT03003884|Drug|Propofol|Initial dose plus supplemental doses as necessary.
15984576|NCT03003871|Device|Powered toothbrush|Oral-B® AdvancePowerTM 400 series
15984577|NCT03003871|Device|Manual toothbrush|Oral-B® Pro-Health All-In-One
15984578|NCT03003871|Other|Toothpaste|Colgate Maximum Cavity Protection®
15984579|NCT03003871|Other|0.2% chlorhexidine gluconate mouth rinse|CorsodylPTMP
15984580|NCT03003858|Device|0.1% HA-based film-forming device (Gengigel Prof® Fluid)|0.1% HA-based film-forming device (Gengigel Prof® Fluid, Ricerfarma, Milano, Italy) administered (oral rinses for 3-5 min.) three to five times a day over a 4-week period as an adjunct to domiciliary care and oral hygiene instructions and motivation
15984581|NCT03003845|Other|Questionnaires|QOL and pain questionnaires will be given to patients at 3, 6, and 12 months post surgery
15984582|NCT03003845|Other|Collection of Blood samples|Blood for PBLs will be collected at 3, 6, and 12 months post surgery
15984583|NCT03003832|Other|Change in electronic health record default for new opioid analgesic prescriptions|
15984584|NCT03003819|Device|Control Collagen Wound Dressing|Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic and local anesthetic, minimally traumatic extraction will be performed with periotomes . After degranulation and bone graft placement, control or test biomaterial will be placed according to the randomization schedule and surgical instructions for each biomaterial.
15984585|NCT03003819|Device|Test Collagen Matrix|Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic and local anesthetic, minimally traumatic extraction will be performed with periotomes . After degranulation and bone graft placement, control or test biomaterial will be placed according to the randomization schedule and surgical instructions for each biomaterial.
15984586|NCT03003806|Device|DreaMed Advisor Pro|Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted using the DreaMed Advisor Pro
15984587|NCT03003806|Other|Medical guided recommendation|Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted by the medical team
15984588|NCT03003793|Diagnostic Test|Hyperinsulinemic euglycemic clamp|Hyperinsulinemic euglycemic clamp to detect insulin sensitivity
15984589|NCT03003780|Behavioral|Mindful Steps|Integrated website, activity tracker, and mind-body training
15984590|NCT03003754|Behavioral|High Intensity Training (HIT) + Resistance Training (RT)|Exercise will be performed at three sessions per week. Post statistical analyses will be including analyses by the 3 sub-groups proposed. All sessions will be supervised by an exercise physiologist during 6 weeks.
15984591|NCT03003754|Behavioral|Control group|Post statistical analyses will be including analyses by the 3 sub-groups proposed Exercise will be performed at three sessions per week. All sessions will be supervised by an exercise physiologist during 6 weeks.
15984592|NCT03003728|Drug|Elotuzumab|Elotuzumab 10 mg/kg via intravenous infusion on days -16, -3, 12, and 26
15984593|NCT03003728|Drug|Melphalan|Melphalan 200 mg/m2 Ivia intravenous infusion on day -3
15984594|NCT03003728|Procedure|Autologous Stem Cell Transplant (ASCT)|ASCT on day -2
15984595|NCT03003728|Biological|Expanded Natural Killer (ENK) Cells|ENK cell infusion on day 0
15984596|NCT03003728|Drug|ALT-803|ALT-803 (Interleukin-15 superagonist) 10 ug/kg via subcutaneous injection on days 1, 8, 15, and 22
15984597|NCT03003715|Procedure|PET Scans|Two 90 minute scans whose maximum radiological dose is 15 mCi [11 C] carfentanil, a selective and specific mu-opioid receptor radioligand. The first one provided baseline data, and the second occurred with the sequence of sham tDCS and tDCS as described in each arm description.
15984663|NCT03003260|Other|Placebo|
15984599|NCT03003715|Procedure|MRI|No radiotracer is used; 3 tesla scanner; all participants have MRI prior to PET scans.
15984600|NCT03003715|Other|sham tDCS (prior to real tDCS)|For sham tDCS, current is applied only for 30 seconds, as sensations arising from tDCS treatment occur only at the beginning of application; however the equipment will be on the participant for 20 minutes to match that of the active tDCS application.
15984601|NCT03003702|Device|Nonin|
15984602|NCT03003689|Procedure|Scaling and Root Planing|Standard of care scaling and root planing using hand instruments and ultrasonic scaler
15984603|NCT03003689|Device|Er:YAG Laser|Er:YAG laser as an adjunct therapy to standard of care scaling and root planing using hand instruments and ultrasonic
15984604|NCT03003676|Biological|ONCOS-102|Engineered oncolytic adenovirus expressing Granulocyte-macrophage colony stimulating factor (GM-CSF)
15984605|NCT03003676|Drug|Cyclophosphamide|Pre-treatment
15984606|NCT03003676|Drug|Pembrolizumab|PD1 blockade
15984607|NCT03003663|Device|SensableCare System|The SensableCare System is evaluated for reducing bed falls.
15984608|NCT03003650|Device|ACURATE TF™|ACURATE TF™Transfemoral Aortic Bioprosthesis is intended for subjects with severe symptomatic Aortic Stenosis and are considered high risk for surgical conventional Aortic Valve Replacement .
15984609|NCT03003637|Drug|Nivolumab|Nivolumab (240 mg flat dose, week 1 and week 3, twice in total) monotherapy, neoadjuvant to SOC (surgery with or without adjuvant (C)RT).
15984610|NCT03003637|Drug|Ipilimumab|Ipilimumab (1 mg/kg) only in week 1, in combination with nivolumab (240 mg flat dose, week 1 and week 3, twice in total), neoadjuvant to SOC (surgery with or without adjuvant (C)RT).
15984611|NCT03003624|Device|Colorado® microdissection needle|The primary feature of the Colorado® microdissection needle is the ultra-sharp tungsten tip that delivers the wave-form from the electrosurgery generator to a very small spot. This allows the use of extremely low wattages, resulting in less tissue necrosis, precision cutting and cautery, and less post-operative pain.
15984612|NCT03003624|Device|Cautery tip|Studies have shown that, heat generated by electrosurgical devices are influenced by factors like duration of contact between tissue and electrode tip, current intensity, electro section waveform and the electrode tip size. A larger tip causes more tissue damage, increased operating power and more amount of lateral heat production. This led to the development of microdissection needle with fine electrode tip and efficient power usage. The use of microdissection needles does not have any significant difference in wound healing or pain when compared with scalpel.
15984613|NCT03003624|Device|BP blade|Studies have shown that, heat generated by electrosurgical devices are influenced by factors like duration of contact between tissue and electrode tip, current intensity, electro section waveform and the electrode tip size. A larger tip causes more tissue damage, increased operating power and more amount of lateral heat production. This led to the development of microdissection needle with fine electrode tip and efficient power usage. The use of microdissection needles does not have any significant difference in wound healing or pain when compared with scalpel.
15984614|NCT03003611|Procedure|hypnose sedation|Patient will be anesthetized with an hypnose sedation and a complement with light anesthesia
15984615|NCT03003611|Procedure|general anesthesia|Patient will be anesthetized with a classical general anesthesia
15984616|NCT03003598|Other|Videolaryngoscope|This device is used in endotracheal intubation and tonopen device for measuring of intraocular pressure. The investigators want to evaluate which one is better.
15984617|NCT03003598|Other|Direct laryngoscope|This device is used in endotracheal intubation and tonopen device for measuring of intraocular pressure. The investigators want to evaluate which one is better.
15984618|NCT03003585|Other|Direct laryngoscope|This device is used in endotracheal intubation and tonopen device for measuring of intraocular pressure. The investigators want to evaluate which one is better.
15984619|NCT03003585|Other|Fiberoptic bronchoscope|This device is used in endotracheal intubation and tonopen device for measuring of intraocular pressure. The investigators want to evaluate which one is better.
15984620|NCT03003572|Other|Blood samples|Blood samples will be collected at inclusion to determine anti-Ro/SSA IgE titers (Enzyme Linked ImmunoSorbent Assay ELISA).
15984621|NCT03003559|Device|High flow nasal cannula|High flow nasal cannula (HFNC) is a new emerging noninvasive respiratory support technology, which mainly includes high flow (15-60 L/min) device, heating humidification device and nasal cannula for high flow. A large number of physiological studies confirmed that HFNC has the following critical physiological effects: promoting airway humidification, improving tolerance of treatment, reducing the physiological dead space on the upper respiratory tract, producing a certain level of positive end expiratory pressure (2-7 cmH2O), decreasing the work of breathing and so on.
15984622|NCT03003546|Other|Laboratory Biomarker Analysis|Correlative studies
15984623|NCT03003546|Drug|Nab-paclitaxel/Rituximab-coated Nanoparticle AR160|Given IV
15984624|NCT03003546|Other|Pharmacological Study|Correlative studies
15984625|NCT03003533|Genetic|SPK-8011|A novel, bio-engineered, recombinant adeno-associated viral vector carrying human factor VIII gene
15984626|NCT03003520|Drug|Durvalumab|"Durvalumab was supplied in single use vials as a liquid solution containing 500 mg (nominal) of durvalumab at a concentration of 50 mg/mL to be infused by intravenous (IV) injection.
~Day 1 of each treatment cycle (Induction Period and Consolidation Period) started with the administration of IV durvalumab followed by a 2-hour observation period post infusion."
15984627|NCT03003520|Drug|Rituximab|Subsequent to durvalumab infusion, rituximab was administered by IV. Rituximab administration could be split over 2 consecutive days according to local clinical practice. Rapid infusion of rituximab was not allowed in this clinical study.
15984628|NCT03003520|Drug|Doxorubicin|A component of the CHOP therapy administered by IV. CHOP therapy was administered following rituximab.
15984629|NCT03003520|Drug|Vincristine|A component of the CHOP therapy administered by IV. CHOP therapy was administered following rituximab.
15984630|NCT03003520|Drug|Cyclophosphamide|A component of the CHOP therapy administered by IV. CHOP therapy was administered following rituximab.
15984631|NCT03003520|Drug|Prednisone|"Prednisone was administered as an IV infusion or by mouth (PO) on Day 1, followed by PO administration on Days 2-5 of each cycle.
~Prednisone could be given prior to other drugs of the CHOP therapy. It was administered after lenalidomide dosing in the R2-CHOP treatment arm."
15984632|NCT03003520|Drug|Lenalidomide|Lenalidomide was administered orally in capsule form on Days 1-14 of the DUR+R2-CHOP treatment arm only.
15984633|NCT03003507|Dietary Supplement|Enteral Formula With Fructose|Low-carbohydrate Enteral Formula With Fructose
15984634|NCT03003507|Dietary Supplement|Enteral Formula Without Fructose|Low-carbohydrate Enteral Formula Without Fructose
15984635|NCT03003494|Drug|Spiolto® Respimat®|observations taken in a period of approximately 6 weeks
15984636|NCT03003468|Drug|Imprime PGG|Arm A: Phase Ib Cohort 1: 2mg/kg IV; Arm A: Phase Ib Cohort 2: 4mg/kg IV
15984637|NCT03003468|Drug|MK-3475|200mg IV
15984638|NCT03003468|Drug|Imprime PGG|Arm B: Phase II treatment: administered at the maximum safe dose of 2mg or 4 mg as established in the Phase Ib cohort study.
15984639|NCT03003455|Procedure|Nasotracheal intubation over a bougie|Nasotracheal intubation over a bougie, placed with videolaryngoscopy assistance, via a nasopharyngeal airway with or without the aid of Magill forceps
15984640|NCT03003455|Procedure|Conventional Nasotracheal Intubation|Blind passage of an endotracheal tube via the nare followed by videolaryngoscopy-assisted passage through the glottis, with or without the aid of Magill forceps
15984641|NCT03003442|Dietary Supplement|Supradyn® Energy 3RDA|Multivitamin/mineral containing co-Q10
15984642|NCT03003442|Dietary Supplement|Placebo|Placebo
15984643|NCT03003429|Other|Heart rate monitor|The intervention consist in monitoring the heart rate variability during one night by using a heart rate monitor and a Polar RS800CX
15984644|NCT03003416|Drug|dexamethasone intravitreal implant|Dexamethasone intravitreal implant (OZURDEX®) as prescribed in clinical practice.
15984645|NCT03003403|Behavioral|Intervention Program|Balance is testing a pragmatic approach to promote weight maintenance among overweight patients and patients with obesity within local community health centers who experience barriers to losing weight. The intervention utilizes the interactive obesity treatment approach, which creates an energy deficit by having participants achieve simple, straightforward, and concrete behavior change goals (e.g., no fast food, no sugary drinks, walk 10,000 steps per day). The Balance intervention involves tailored behavior change goals; self-monitoring using connected scales and mobile technologies; responsive coaching, and tailored feedback and skills training.
15984646|NCT03003390|Drug|Enoxaparin|The clinical nurse will give enoxaparin subcutaneously every 12 hours at the currently used starting dose of 0.75 mg/kg for children ≤2 months old or 0.5 mg/kg (maximum of 40 mg) for older children. The 1st dose will be given <24 hours after insertion of the catheter. Doses will be adjusted to target an anti-Xa level of 0.2-0.5 IU/mL.
15984647|NCT03003377|Device|laryngeal mask supreme|Sevoflurane was administered by facial mask with concomitant remifentanil administration (at an effect-site of 4 ng/ml). The LMAS was inserted according to the manufacturer's recommendations with the patient's head in the neutral position. After equilibrium the LMAS was inserted and secured according to the manufacturer's recommendations, without using muscle relaxants. A single measurement will be obtained from each patient. If the patient reacted with movement, a 1-2 mg/kg dose of Propofol was administered.
15984648|NCT03003377|Device|laryngeal mask proseal|Sevoflurane was administered by facial mask with concomitant remifentanil administration (at an effect-site of 4 ng/ml).The LMAP was inserted according to the manufacturer's recommendations with the patient's head in the neutral position. After equilibrium the LMAP was inserted and secured according to the manufacturer's recommendations, without using muscle relaxants. A single measurement will be obtained from each patient. If the patient reacted with movement, a 1-2 mg/kg dose of Propofol was administered.
15984649|NCT03003364|Drug|XCEL-UMC-BETA|Intrathecal allogeneic cell therapy in a blinded syringe
15984650|NCT03003364|Drug|Placebo|Placebo in a blinded syringe
15984651|NCT03003338|Drug|OBV/PTV/r and DSV|OBV/PTV/r (12.5 mg/ 75 mg/ 50 mg) in combination with DSV (250 mg): Two tablets of OBV/PTV/r in the morning and one tablet of DSV in the morning and one tablet of DSV in the evening orally with a meal without regard to fat or calorie content.
15984652|NCT03003338|Drug|Placebo to match OBV/PTV/r and DSV|Placebo to match OBV/PTV/r and DSV
15984653|NCT03003325|Drug|AOP2014|AOP2014 will be supplied to the patients as pre-filled auto-injection pens, containing 250 µg of active drug (0.5 ml solution for injection). One pen may be used twice within a time period of 4 weeks. Hence investigators will provide one prefilled pen at every monthly visit. AOP2014 will be self-injected subcutaneously by patients once every 14 days at the single doses of 100 µg (0.2 ml).
15984654|NCT03003325|Procedure|Phlebotomies|According to current common clinical practice the regimen must be selected accordingly to maintain the recommended level of HCT< 45%. Once normalization of the hematocrit has been achieved, blood counts at regular intervals (every 4 weeks) will establish the frequency of future phlebotomies. Sufficient blood should be removed to maintain the hematocrit below 45%.
15984655|NCT03003325|Drug|ASA|100 mg/daily of ASA is recommended (when there are not contraindications) according with current guidelines for this risk class of patients
15984656|NCT03003299|Device|Edwards SAPIEN 3 THV|Edwards SAPIEN 3 THV system Model 9600TFX with the associated delivery systems.
15984657|NCT03003286|Behavioral|Unstuck and on Target (UOT)|Unstuck and on Target (UOT) is a novel and innovative cognitive-behavioral treatment that directly addresses executive functioning and self-regulation deficits in ASD and ADHD. UOT is the first contextually-based EF treatment that targets flexibility, goal-setting and planning through a cognitive-behavioral program centered on self-regulatory scripts that are consistently modeled and reinforced. Parents, teachers, and interventionists will be taught to model and support flexibility across settings. Children will also participate in a peer group intervention setting.
15984658|NCT03003286|Behavioral|Parents and Teachers Supporting Students (PATSS)|The Contingency Behavior Management (CBM) intervention was developed by the researchers and called Parents and Teachers Supporting Students (PATSS) as a current best practice intervention that was comparable in design to Unstuck and on Target. The goal is to improve child behavioral outcomes by training parents, teachers and interventionists in core principles of behavior management like social learning and behavioral change. Children were also included in small group sessions where they identify their own behavior goals and meaningful reinforcers.
15984659|NCT03003273|Other|stoppage of antibiotics|antibiotics will be stopped in arm - A on randomization, once child is afebrile for at least 24 hours and fulfills the inclusion criteria.
15984660|NCT03003273|Other|amoxycillin/clavulanic acid|In arm - B, once the child is randomized, oral antibiotics will be started (Amoxicillin/ Clavulanic acid + Levofloxacin)
15984661|NCT03003273|Other|levofloxacin|In arm - B, once the child is randomized, oral antibiotics will be started (Amoxicillin/ Clavulanic acid + Levofloxacin)
15984668|NCT03003234|Procedure|Duodenogastroscopy|Catheter goes through the mouth in the duodenum to take duodenal biopsies.
15984669|NCT03003234|Device|Duodenal aspiration catheter|Catheter goes through the nose in the duodenum to aspirate duodenal fluid in fasted and fed state.
15984670|NCT03003234|Dietary Supplement|Nutri drink|Liquid meal of 200 ml.
15984671|NCT03003221|Behavioral|AIR-P Dental Toolkit|The AIR-P Dental Toolkit is designed to provide caregivers with guidance and information related to dental care and support strategies for children with autism spectrum disorder.
15984672|NCT03003221|Behavioral|Parent Training|The parent-training intervention integrates strategies shown to be efficacious for: 1) improving adherence to dental care, 2) enhancing dental experiences for children with neurotypical development and high levels of dental fear, and 3) evidence-based behavioral techniques established for children with autism spectrum disorder.
15984673|NCT03003208|Other|Pulmonary rehabilitation|An exercise and education program
15984674|NCT03003195|Drug|P10s-PADRE|All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection for a total of 4 vaccinations.
15984675|NCT03003169|Other|Medical questionnaire|"quality of life questionnaire (EORTC QLQ-C30 and QLQ-BR23)
~Hospital Anxiety and Depression scale
~satisfaction care questionnaire (IN-PATSAT32)"
15984676|NCT03003156|Procedure|25 Hz magnetic seizure therapy|In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of 25 Hz MST in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks.
15984677|NCT03003156|Procedure|50 Hz magnetic seizure therapy|In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of 50 Hz MST in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks.
15984678|NCT03003143|Drug|Vigabatrin 500 MG|
15984679|NCT03003130|Device|Restylane Defyne|Intradermal injection
15984680|NCT03003130|Device|Restylane|Intradermal injection
15984681|NCT03003117|Behavioral|Experimental: Intervention Program|"The home based educational component from the 3rd trimester of pregnancy to when the child is aged 24 months seeks to build knowledge, skills and social support (social cognitive theory, anticipatory guidance) to the parents regarding feeding practices (focussing on breastfeeding and complementary feeding), consistent with the French Nutrition and Health Program (PNNS) guidelines (component 1). Fresh fruit and vegetable baskets are made available at a reduced price from the 3rd trimester of pregnancy to when the toddler is aged 24 m (component 2), along with the provision of follow-on formula and baby food vouchers from 6 to 24 m (component 3).
~One home visit is scheduled during the 3rd trimester of pregnancy. Another visit will take place in the maternity ward after the child is born. Five further home visits will take place when the child is aged 3, 6, 12, 18 and 24 m."
15984682|NCT03003117|Behavioral|Active comparator: Usual Care|Usual Care reflects the standard treatment currently provided within the frame of the French health care system. One home visit is scheduled during the 3rd trimester of pregnancy. Another visit will take place in the maternity ward after the child is born. Five further home visits will take place when the child is aged 3, 6, 12, 18 and 24 m. If nutritional questions are raised by parents, dieticians will restrict their responses based on the food guides of the PNNS.
15984683|NCT03003104|Drug|DMT210 Topical Gel 5%|
15984684|NCT03003104|Other|Vehicle Control|
15984685|NCT03003091|Other|Needs-based patient education|
15984686|NCT03003091|Other|Traditional patient education|
15984687|NCT03003078|Device|OncoSil™|The implantation of OncoSil™
15984688|NCT03003065|Drug|Temoporfin|A single treatment with Temoporfin (Foscan) 3 mg given intravenously followed by PDT with laser light at 652 nm (Ceralas, Biolitec, Germany) within 72 hours
15984689|NCT03003052|Procedure|Dental implants|Data collection from pre-implant assessment, implant surgery, and hygiene recall appointments, to assess implant survival and success.
15984690|NCT03003039|Biological|GB241|Single intravenous infusion (IV) 375 mg/m2
15984691|NCT03003039|Biological|Rituximab|Single intravenous infusion (IV) 375 mg/m2
15984692|NCT03003026|Other|Novel task-specific bike skills training program|Participants randomised to the intervention group will participate in a novel task-specific bike skills training program. The intervention involves seven key components: it is group-based, intensive (2 hours per day for 3 days plus a home program for the remaining days of the one week period), task-specific, goal-directed, and therapist led, with parent involvement and conducted in an ecological setting. Each program will be run by a physiotherapist and allied health assistant during the school holidays.
15984693|NCT03003026|Other|Parent-led home-based bike skills training program|The comparison group will involve a parent-led home-based bike skills training program. Parents of children randomized to the comparison group will receive written information and telephone support from a physiotherapist on training bike skills. They will be encouraged to work with their child towards their bike skills goals for at least 30-45 minutes per day over a one week period during the school holidays in home and community environments.
15984694|NCT03003013|Procedure|Biphasic Bone Graft Material (BGM) in Combination With Autologous Platelet-rich Fibrin (PRF)|
15984695|NCT03003000|Drug|ibuprofen|
15984696|NCT03003000|Drug|caffeine|
15984697|NCT03003000|Drug|placebo|
15984698|NCT03002987|Behavioral|Active Pregnancy policy|Education (3 hours) of leaders in how to implement Active pregnancy policy at their departments/work places
15984699|NCT03002974|Drug|Anakinra 100 mg|100 mg/0.67 mL solution in single-use prefilled syringes for subcutaneous injection
15984700|NCT03002974|Drug|Triamcinolone Acetonide 40 mg|1 mL intramuscular injection of a 40 mg/mL injectable suspension
15984701|NCT03002974|Drug|Placebo to Anakinra 100 mg|sterile solution for injection (0.67 mL) in a single-use prefilled syringe identical to the anakinra syringe
15984702|NCT03002974|Drug|Placebo to Triamcinolone Acetonide 40 mg|1 mL intramuscular injectable suspension with identical appearance as the Triamcinolone Acetonide suspension
15984703|NCT03002961|Drug|RBP-6000|single dose of RBP-6000, preceded by a pharmacokinetic (PK) sample followed by serial PK samples post-dose. Additionally subjects to remain in the clinic through Day 21 for safety assessments
15984704|NCT03002961|Drug|Suboxone|RBP-6000 injection after 7 days of SL Suboxone administration. Interventions as above with additional daily PK collections during Suboxone treatment prior to RBP-6000 administration
15984705|NCT03002948|Other|Orgasm|"clitoris volume, suprapubic angle, urethra-levator gap, suburethral triangle area measurement could made using 4 D transperineal ultrasonography. Clitoris fourchette distance, clitoris perineal body distance, clitoris urethra distance could made with special compasses.
~Female Sexual Function Index orgasm domain score"
15984706|NCT03002935|Drug|BPM31510 Oral Nanosuspension 4%|Oral nanosuspension formulation of BPM31510 (ubidecarenone, USP)
15984707|NCT03002922|Drug|BAY987517|Sunscreen formula Y65-158
15984708|NCT03002909|Device|epidural catheter|
15984709|NCT03002909|Device|preperitoneal catheter|
15984710|NCT03002896|Behavioral|Pep-Pal|Pep-Pal is designed to complement the utilization of other resources, provide support when no other resources can be obtained, or provide support in the interim until greater resources can be obtained. In this way, Pep-Pal is a resource for our most hard to reach caregivers.
15984711|NCT03002896|Other|Treatment as Usual|
15984712|NCT03002883|Behavioral|Usual Care|"Participant provided Quit Kit water bottle with small cessation aids (eg. sunflower seeds) and educated about student health as a cessation resource"
15984713|NCT03002883|Behavioral|Brief Motivational Interviewing|Peer educator conducts brief motivational interviewing about smoking cessation and participant goals
15984714|NCT03002883|Behavioral|Direct referral to quitline|Peer educator educates about state quitline services and gets verbal consent to use quitline's direct referral web portal for quitline to contact participant in 1-2 business days about free counseling services to make a quit plan
15984715|NCT03002870|Other|Questionnaires|Patients will receive questionnaires yearly to follow their QOL
15984716|NCT03002857|Device|LMA-C|LMA-C will be placed into the patients airway following anesthesia induction. The placement will be done as suggested in supine position with a standard gel pillow under patients head.
15984717|NCT03002857|Device|Baska Mask|Baska Mask will be placed into the patients airway following anesthesia induction. The placement will be done as suggested in supine position with a standard gel pillow under patients head.
15984718|NCT03002857|Device|I-gel|I-gel LMA placement will be done as suggested in supine position with a standard gel pillow under patients head.
15984719|NCT03002844|Drug|EGFR-TK Inhibitor|EGFR-TKI (gefitinib 250mg per day)
15984720|NCT03002844|Drug|EGFR-TKI|EGFR-TKI (gefitinib 250mg per day)
15984721|NCT03002844|Drug|EGFR-TKI and Chemotherapy|pemetrexed 500mg per kg q3w/gemcitabine 1000mg per kg q3w and carboplatin AUC=5 q3w
15984722|NCT03002831|Biological|Cytokine-induced Killer Cells|
15984723|NCT03002831|Drug|Tegafur-Gimeracil-Oteracil Potassium|
15984724|NCT03002805|Drug|CBT-1®|"CBT-1®, oral, on days 1-7 of each cycle 21-day cycle. Participants will be assigned to dose level of CBT-1®:
~Dose level 1 - 50 mg/m2/day Dose level 2 - 100 mg/m2/day Dose level 3 - 150 mg/m2/day Dose level 4 - 200 mg/m2/day Dose level 5 - 250 mg/m2/day Dose level 6 - 300 mg/m2/day doxorubicin, 37.5 mg/m2, IV, on days 5 and 6 of each cycle Study treatment discontinued after 450 mg/m2 lifetime cumulative dose of doxorubicin reached or after 4-5 cycles completed."
15984725|NCT03002792|Procedure|general anesthesia|nitrous oxide, sevoflurane, propofol, cisatracurium, fentanyl for induction and maintenance with sevoflurane
15984726|NCT03002779|Drug|JNJ-53718678|Participants will receive a single 500 milligram (mg) dose of 14C-JNJ-53718678 as an oral liquid solution containing 14C-labeled and unlabeled JNJ-53718678 corresponding to a radioactivity dose.
15984727|NCT03002766|Procedure|Breast conservative surgery|
15984728|NCT03002753|Behavioral|detached mindfulness|Please see detailed study description.
15984729|NCT03002753|Behavioral|cognitive restructuring|Please see detailed study description.
15984730|NCT03002714|Other|Exercise|
15984731|NCT03002701|Behavioral|UNDERPIN-ICU program|UNDERPIN-ICU consists of standardized protocols focusing on several modifiable risk factors for delirium, including cognitive impairment, sleep deprivation, immobility and visual and hearing impairment.
15984732|NCT03002688|Other|Survey|Verbal survey will be given before and after the cataract surgery, and on the day following the second cataract surgery.
15984733|NCT03002675|Drug|Bydureon|exenatide (Bydureon) 2mg s.c. 1x/wk
15984734|NCT03002662|Other|colonoscopy|
15984735|NCT03002649|Drug|Tofacitinib|Tofacitinib comes as an extended-release (XR) (long-acting) tablet to take by mouth. The extended-release tablet is usually taken with or without food once daily.
15984736|NCT03002636|Procedure|anesthesia|Anesthesia : (1) General Anesthesia (GA)(2) Epidural Anesthesia (EA) (3) Combined Spinal-Epidural Anesthesia (CSEA)
15984737|NCT03002623|Drug|CUDC-907|60 mg (2 capsules of 30 mg capsules) will be given orally once a day 5 days on and 2 days off.
15984738|NCT03002610|Other|Pls|Text format with simple explanation of the survey topic main findings and is intended for lay audience.
15984739|NCT03002610|Other|Infographics|Cochrane started developing infographics, where short textual information about research is supported by visual representations of the main findings and is also aimed at the lay public The investigators will examine whether this format is better in information uptake than standard PLS.
15984740|NCT03002610|Other|Scientific abstract|Scientific abstract the text written for the academic population and practitioners, with scientific abbreviations which enables experts to go into more detail about the topic.
15984741|NCT03002597|Device|BrainPort V200 Device|To see if the device can be used in a pediatric population by measuring the subjects' improvement over baseline in any of the following areas: light detection, light localization, movement perception, and standardized object recognition tasks after use of the BrainPort.
15984742|NCT03002584|Other|completion of self-reported questionnaires|"Single completion: Participants will have to complete the IGQ, the generic health status EQ-5D questionnaire, the specific FDDQL questionnaire (Functional Digestive Disorders Quality of Life).
~Test-retest: during the second completion within a mean 7-day interval, participants will complete the IGQ and a single global Gastro-Intestinal Well-Being scale"
15984743|NCT03002571|Drug|IDP-124 Lotion|Lotion
15984744|NCT03002571|Drug|IDP-124 Vehicle Lotion|Lotion
15984745|NCT03002545|Dietary Supplement|Magnesium citrate|
15984746|NCT03002545|Dietary Supplement|Placebo|
15984747|NCT03002532|Radiation|whole brain radiotherapy|
15984748|NCT03002519|Biological|PLX-R18|Intramuscular (IM) administration of PLX-R18
15984749|NCT03002506|Drug|Ceftolozane/tazobactam|Single dose of 2 grams/1 gram intravenously administered over 60 minutes.
15984750|NCT03002493|Drug|Eribulin mesylate|"Treatment phase: During Cycle 1, eribulin mesylate was administered as a 2 to 5 minute (min) intravenous (IV) infusion at 1.4 mg/m2 on Day 1 and Day 15 of 21-day cycle. During subsequent cycles, eribulin mesylate administration as a 2 to 5 min IV infusion at 1.4 mg/m2 on Day 1 and Day 8 of a 21-day cycle.
~Extension phase: Eribulin mesylate was administered continuously as a 2 to 5 min IV infusion at 1.4 mg/m2 on Day 1 and Day 8 of 21-day cycles, as long as the Investigator considered eribulin mesylate therapy to be clinically appropriate."
15984751|NCT03002493|Drug|Eribulin mesylate|
15984752|NCT03002493|Drug|Rifampicin|Treatment phase: Rifampicin 600 mg was administered orally once a day, from Day 9 to Day 20 of 28-day cycle of Cycle 1.
15984753|NCT03002480|Other|Thromboelastography-Guided Treatment Regimen|"The thromboelastograph (TEG) will be used to determine the best bypassing agent for the management of subjects with severe hemophilia A with inhibitors. Patients will be assigned that bypassing agent and dose for the treatment of their bleeding episodes and subsequently will be followed for a period of 6 months to determine their annual bleeding rate."
15984754|NCT03002467|Other|PESI score|
15984755|NCT03002454|Drug|99mTc MDP Injection:neutron-bombardment|Technetium (99mTc) Medronate Injection USP labeled with 99mTc derived from neutron-activation-produced 99Mo.
15984756|NCT03002441|Device|Same-Day Dilapan-S|Dilapan-S cervical dilators placed the same day as the D&E procedure
15984757|NCT03002441|Device|Overnight Dilapan-S|Dilapan-S cervical dilators placed the day prior to D&E procedure
15984758|NCT03002428|Drug|Teriparatide (PF708)|Subcutaneous injection
15984759|NCT03002428|Drug|Teriparatide (Forteo)|Subcutaneous injection
15984762|NCT03002402|Behavioral|Internet-based CBT-I|Internet-based cognitive-behavioral treatment for insomnia
15984763|NCT03002389|Drug|Anoro Ellipta|inhaler approved by FDA (strength umeclidinium 65 microgram + vilanterol 25 microgram) One puff once a day for 30 days
15984764|NCT03002389|Drug|Arnuity Ellipta|inhaler approved by FDA (strength 250 microgram) One puff twice a day for 30 days
15984765|NCT03002376|Drug|REGN2810|REGN2810 treatment
15984766|NCT03002363|Behavioral|Video Modeling Intervention|Prior to arrival of the audiological evaluation, the child and caregiver will be required to watch one of two videos created by the research personnel. One video, the intervention video, is a behavior modeling video walking through the entire audiological evaluation. It also includes tips for caregivers to practice with their child before the appointment. The other video is a placebo video that discusses hearing, listening and ears, that does not discuss tips for caregivers to practice with their child before the appointment. The placebo video is not related to the audiological evaluation.
15984767|NCT03002363|Behavioral|Placebo Video|The other video is a placebo video that discusses hearing, listening and ears, that does not discuss tips for caregivers to practice with their child before the appointment. The placebo video is not related to the audiological evaluation.
15984768|NCT03002337|Behavioral|Aromatherapy massage|All of the participants in the aromatherapy group underwent aromatherapy massage for 70 minutes every two weeks between 16 to 36 weeks GA (ten sessions total). The aromatic massage oils were composed of 2 c.c. lavender (Lavandula angustifolia) blended with 98 c.c. almond oil. This concentration of the mixed essential oil was kept at room temperature for massage use.
15984769|NCT03002337|Behavioral|Yoga exercise|Prenatal yoga was offered in six 70-minute yoga sessions per week for 20 weeks, with 10-12 women in each session. Each participant should attend two sessions of yoga every two days, held in a quiet room near the prenatal clinic. Yoga specifically designed for women during the second and third trimesters, was guided by a midwife who was certified as a yoga instructor. Yoga included physical postures/ stretch, deep breathing, guided imagery, and deep relaxation. Before each posture/stretch, the instructor guided participants to relax each body part and calm their mind.
15984770|NCT03002324|Behavioral|Baseline Survey|The baseline survey is a combination of the Vaccine Confidence Scale, and a short form of the Parents' Attitudes about Childhood Vaccines (PACV) Scale. Participants will be asked an additional 10 questions developed as a part of a behavioral phenotyping questionnaire to assess behavioral biases at baseline within the study population. Demographic information and intent to vaccinate will also be collected.
15984771|NCT03002324|Behavioral|Current CDC Message|Participants randomized to the current CDC message arm will read a message taken almost directly from the CDC Vaccine Information Sheet (VIS) on HPV. This message was minimally altered for length and clarity.
15984772|NCT03002324|Behavioral|Cervical Cancer Message|Participants randomized to the cervical cancer messaging arm will receive a message developed by the study team to appeal tenants of the Health Belief Model (self-efficacy, perceived benefit) and on the purity tenant of the moral foundations theory.
15984773|NCT03002324|Behavioral|Control Message|Participants randomized to the non-vaccine related control arm will read a bird-feeding passage.
15984774|NCT03002324|Behavioral|Post-Intervention Survey|The immediate post-intervention survey will include questions from the Vaccine Confidence Scale and the PACV short scale. Intent to vaccinate will be assessed.
15984808|NCT03002090|Dietary Supplement|BZKL Untrained|1. BaZhen KeLi capsules: Traditional Chinese herbal supplement composed of: Radix Paeoniae Alba (White peony root), Rhizoma Atractylodis (Atractylodes), Rhizoma Chuanxiong (Chuanxiong), Radix Angelicae Sinensis (Angelica), Radix Codonopsis Pilosula (Codonopsis), Poria cocos (Poria), licorice, and Rehmannia glutinosa Each pill contained 5g of licorice and 10g of all other ingredients. Dosed in 2 capsules taken individually by mouth with breakfast and dinner. Analysis has shown that each capsule contained 0.5mg of elemental iron.
15984809|NCT03002090|Dietary Supplement|Placebo Trained|1. Aerobic Training: 25 minutes/day, 5 days/week for 8 weeks working at an intensity between 75-85% of age-predicted maximum heart rate.
15984775|NCT03002311|Device|Epharmix/CareSignal eHealth|The self-scheduling text and phone messaging system was built by Epharmix/CareSignal. Participants in the intervention group began receiving text or voice messages (for landlines) starting 1 hour following ED discharge if during normal business hours, or at 1000 the next business morning. Automated messages were sent up to 3 days in a row or until the participant responded or opted out. The phone system would ultimately connect them directly to their referral provider or clinic to schedule an appointment. Once participants hung up with the referral clinic, the intervention texted or called back to solicit the appointment date. If a date was entered, the system sent reminders at 14 days, 7 days, 3 days, and 1 day before the appointment. After the appointment, the intervention texted or called participants to confirm if they attended.
15984776|NCT03002298|Behavioral|DMD gesture task|Timing coincident task in a virtual environment, using motor learning protocol in which a gesture in front of a webcam shoub be done to reach the task
15984777|NCT03002298|Behavioral|DMD button-press task|Timing coincident task in a virtual environment, using motor learning protocol in which the task shoub be done by pressing a button on the keyboard
15984778|NCT03002298|Behavioral|Control group gesture task|Timing coincident task in a virtual environment, using motor learning protocol in which a gesture in front of a webcam shoub be done to reach the task
15984779|NCT03002298|Behavioral|Control group button-press task|Timing coincident task in a virtual environment, using motor learning protocol in which the task shoub be done by pressing a button on the keyboard
15984780|NCT03002285|Behavioral|Cerebral Palsy group|Group with Cerebral Palsy that performed the Fitts law in a computer task
15984781|NCT03002285|Behavioral|Control group|Group with typical development that performed the Fitts law in a computer task
15984782|NCT03002272|Device|TAVR|subjects that underwent TAVR more than 3 years ago
15984783|NCT03002272|Device|SAVR|Historical controls will be selected from among patients at the same site who underwent isolated bioprosthetic SAVR more than 3 years ago
15984784|NCT03002259|Drug|Dexamethasone|Dexamethasone administered as a single IV injection after induction of anaesthesia, but before initiation of CPB. Prepare as a 20 mg/mL dexamethasone solution, made up with 0.9% saline to 10 ml.
15984785|NCT03002246|Other|Ultrasound Examination|Research volunteers will be invited to have a 2D/3D ultrasound research scan 4-7 days from delivery.This ultrasound scan will take approximately 30 minutes to complete.
15984786|NCT03002233|Drug|TRK-820|
15984787|NCT03002220|Drug|radium-223|Radium-223 at a dose of 55 kBq
15984790|NCT03002194|Device|Cutometer|Skin elasticity will be measured by a Cutometer prior to beginning treatment, week 7 and 3 months after completion of the treatment.
15984791|NCT03002194|Other|Photographs|Photographs will be taken prior to beginning treatment, week 7 and 3 months after completion of the treatment.
15984792|NCT03002181|Other|Education|70 minute education session.
15984793|NCT03002168|Dietary Supplement|Alpha-cyclodextrin|Alpha-cyclodextrin is approved by the Food and Drug Administration as a dietary ingredient.
15984794|NCT03002168|Dietary Supplement|Placebo|Placebo tablets identical in appearance to the active comparator
15984795|NCT03002168|Radiation|Triolein radiolabeled with 100 microcuries of 3^Hydrogen|A MicroCurie (µCi) is a measure of radioactivity.
15984796|NCT03002168|Radiation|Tripalmitin radiolabeled with 20 microcuries of 14^Carbon|A MicroCurie (µCi) is a measure of radioactivity.
15984797|NCT03002155|Other|EnhanceFitness community exercise program|Level I EnhanceFitness class is a seated fitness class that includes warm up, aerobics, cool down, balance training, strength training, and stretching.
15984798|NCT03002142|Device|Hearing aids|Phonak Audéo B-R (Target V 5.0)
15984799|NCT03002142|Device|Placebo|Phonak Audéo B-R (Target V 5.0) without amplification
15984800|NCT03002129|Other|fluid challenge|At two pre-defined time points during the procedure, enrolled patients will receive a fluid bolus of 5 ml/kg during 5 minutes
15984801|NCT03002116|Other|Tissue thermometry using non-invasive microwave radiometry device|In Patients included in the four study groups underwent non-invasive tissue thermometry using microwave radiometry (MWR) device, at the same room temperature and with the same methodology. Specifically, the probe of the RTM-01-RES (University of Bolton, UK) device was by applied on the surface of the foot tissue at an angle of 90o degrees for approximately 8 to 10 seconds in pre-determined sites. Measurements were performed by two independent operators. Three measurements were taken from each site. The mean value of the three values calculated by the 2 different operators was used for the analysis. Measurements were recorded using a dedicated software.
15984802|NCT03002103|Drug|EndoTAG-1|
15984803|NCT03002103|Drug|Paclitaxel|
15984804|NCT03002103|Drug|Gemcitabine Hydrochloride|
15984805|NCT03002090|Dietary Supplement|Iron trained|"Ferrous sulfate: 100 mg/day of FeSO4 dosed in 2 capsules taken individually by mouth with breakfast and dinner. Capsules were made with FeSO4 and dextrose. Analysis has shown that each capsule contains 11mg of elemental iron, which is expected to be absorbed at roughly 33% bioavailability.
~Aerobic Training: 25 minutes/day, 5 days/week for 8 weeks working at an intensity between 75-85% of age-predicted maximum heart rate."
15984806|NCT03002090|Dietary Supplement|Iron Untrained|1. Ferrous sulfate: 100 mg/day of FeSO4 dosed in 2 capsules taken individually by mouth with breakfast and dinner. Capsules were made with FeSO4 and dextrose. Analysis has shown that each capsule contains 11mg of elemental iron, which is expected to be absorbed at roughly 33% bioavailability.
15984807|NCT03002090|Dietary Supplement|BZKL Trained|"BaZhen KeLi capsules: Traditional Chinese herbal supplement composed of: Radix Paeoniae Alba (White peony root), Rhizoma Atractylodis (Atractylodes), Rhizoma Chuanxiong (Chuanxiong), Radix Angelicae Sinensis (Angelica), Radix Codonopsis Pilosula (Codonopsis), Poria cocos (Poria), licorice, and Rehmannia glutinosa Each pill contained 5g of licorice and 10g of all other ingredients. Dosed in 2 capsules taken individually by mouth with breakfast and dinner. Analysis has shown that each capsule contained 0.5mg of elemental iron.
~Aerobic Training: 25 minutes/day, 5 days/week for 8 weeks working at an intensity between 75-85% of age-predicted maximum heart rate."
15984812|NCT03002064|Drug|Docetaxel|60mg per square metre on day 1, repeated every 3 weeks till progression or at most 6 cycles.
15984813|NCT03002064|Drug|Fluorouracil|5-fluorouracil 3750mg per square metre, civ 120 hours every 3 weeks till progression or at most 6 cycles
15984814|NCT03002064|Drug|Cisplatin|Cisplatin: 60mg per square metre on day 1, repeated every 3 weeks till progression or at most 6 cycles
15984815|NCT03002051|Device|EUS-guided drainage|"Ultrasonographic evaluation of the lesion by linear echoendoscope and positioning for transenteric puncture in shortest distance between enteric wall and the target lumen for drainage.
~EUS-guided transenteric puncture by using a 19-gauge needle followed by placement of a 0.035 or 0.025-inch guidewire into the target lumen.
~After the needle is removed in remaining the guidewire, the tract is dilated over the guidewire by using bougie dilator or needle type cystotome (Endoflex, Voerde, Germany). And then, the tract may be more dilated by using balloon catheter (4-mm).
~After dilation of the tract, stent delivery system is inserted over the guidewire into the target lumen.
~After complete deployment of the distal flange under EUS and fluoroscopic guidance into the target lumen, proximal retraction of the delivery system until the blue mark on the handle of the introducer is seen. And then, the proximal flange is deployed slowly under endoscopic guidance."
15984816|NCT03002038|Drug|Azathioprine|Patients are started with Azathioprine 50 mg tablets, taken orally twice a day. The medication dose is increased gradually with the aim of lymphocytes count bellow 1500 and to the maximum dose of 3 g Azathioprine per day. Cell blood count is checked once a week in the first month of treatment, once every two weeks in the second month of treatment, and monthly in the third month of treatment to make decision about medication dose.
15984817|NCT03002038|Drug|Rituximab|Patients will receive 1 g of Rituximab (two vials of RediTux 500 mg/50 ml) in 500 cc normal saline serum through intravenous infusion and this will be repeated two weeks later. This cycle will be repeated every 6 months.
15984818|NCT03002025|Drug|JNJ-64304500|Participants will receive JNJ-64304500 as SC injection.
15984819|NCT03002025|Drug|Placebo|Participants will receive matching placebo to JNJ-64304500 as SC injection.
15984820|NCT03002012|Drug|Sertraline|sertraline 400mg/day
15984821|NCT03002012|Drug|Placebo Oral Tablet|matched placebo tablet
15984822|NCT03002012|Drug|Fluconazole|Standard of Care Fluconazole per World Health Organization and Ugandan Guidelines (800mg/day x 2 weeks, 400mg/day x10 weeks, 200mg through 6 months).
15984823|NCT03001999|Behavioral|PP-MI health behavior intervention|"The positive psychology exercises include 3 modules:
~Gratitude-based activities, Strength-based activities, and Meaning-based activities. Various goal setting exercises will appear in each of the 14 study sessions."
15984824|NCT03001986|Biological|inactivated EV71 vaccine (KMB-17 cells)|Receiving 2 doses of the EV71 inactivated vaccine at an interval of 1 month.
15984825|NCT03001973|Other|No Intervention|Registration of all LN patients in the First Affiliated Hospital of Sun Yat-sen University and other hospitals which have signed the contract in China.
15984826|NCT03001960|Drug|Preloading before TAVI|Preloading with Aspirin and Clopidogrel before TAVI
15984827|NCT03001960|Drug|Postloading after TAVI|Postloading with Aspirin and Clopidogrel after TAVI
15984828|NCT03001947|Other|No intervention|Registration of all IgAN patients in the First Affiliated Hospital of Sun Yat-sen University and other hospitals which have signed the contract in China.
15984829|NCT03001934|Other|No intervention|Registration of all NS patients in the First Affiliated Hospital of Sun Yat-sen University and other hospitals which have signed the contract in China.
15984830|NCT03001921|Other|No intervention|Registration of all HD patients in the First Affiliated Hospital of Sun Yat-sen University and other hospital which have signed the contract in China.
15984831|NCT03001908|Other|glenohumeral mobilization-oscillation|posterior glide mobilizations oscillated at 1hz, 4 x 30 seconds
15984832|NCT03001908|Other|glenohumeral mobilization-sustained|posterior glide mobilization, sustained 4 x 30 seconds
15984833|NCT03001895|Drug|18F-DCFPyL PET/CT|18F-DCFPyL PET/CT
15984834|NCT03001882|Biological|Nivolumab|Specified dose on specified days
15984835|NCT03001882|Biological|Ipilimumab|Specified dose on specified days
15984836|NCT03001869|Drug|68Ga-HBED-CC-PSMA PET/CT|68Ga-HBED-CC-PSMA PET/CT Scan
15984837|NCT03001856|Procedure|Oblique Intradermal Suture|
15984838|NCT03001856|Procedure|Intradermal Suture|
15984839|NCT03001843|Drug|Ketamine|Anesthesia of only Ketamine
15984840|NCT03001843|Drug|Narcotics|The narcotic group will receive no ketamine but rather a more standard anesthetic
15984841|NCT03001843|Behavioral|pain scale|0-10 pain scale. 0 = no pain and 10 = worst pain
15984842|NCT03001830|Biological|AAV2/8-HLP-FVIII-V3|Infusion of AAV2/8-HLP-FVIII-V3
15984843|NCT03001817|Drug|K-877|
15984844|NCT03001817|Drug|Fenofibrate|
15984845|NCT03001817|Drug|Placebo (for K-877)|
15984846|NCT03001817|Drug|Placebo (for Fenofibrate)|
15984847|NCT03001791|Procedure|Excisional biopsy with Er:YAG laser|Excisional biopsy of fibrous hyperplasia in the buccal mucosa in local anesthesia with Er:YAG laser (Lite TouchTM, Synergon Dental Lasers, Light instruments Ltd., Yokneam Elite, Israel), λ = 2940nnm. Soft tissue biopsy mode with water cooling, frequency 35 Hz, pulse duration 250-390 µsec, pulse energy of 200 mJ, power 7 Watt . Cylindrical sapphire tip, 400 µm in diameter, without contact to the tissue.
15984848|NCT03001791|Procedure|Excisional biopsy with CO2 laser|Excisional biopsy of fibrous hyperplasia in the buccal mucosa in local anesthesia with CO2 laser (Spectra DENTA Surgical Carbon Dioxide Laser, MAX Engineering Ltd., Gyeonggi-Do, Korea), λ = 10'600nnm. cf mode (frequency 140 Hz, pulse duration 400 µsec, pulse energy 33 mJ,a power 4.62 watts). Laser beam with a spot size of 0.2 mm, non-contact mode.
15984849|NCT03001791|Procedure|Excisional biopsy with scalpel|Excisional biopsy of fibrous hyperplasia in the buccal mucosa in local anesthesia with scalpel (blade 15C). Polyamide sutures (Seralon 5-DS15, Serag Wiessner KG, Naila, Germany).
15984850|NCT03001778|Other|Usability Testing|"Usability testing of ready made workouts in a group format."
15984851|NCT03001765|Other|"Intensive Monitoring Strategy: Reveal LINQ™ Insertable Cardiac Monitoring System."|Intensive monitoring strategy of discharge from Emergency Department with 30 day SEEQ external monitor, followed by implantable cardiac Reveal LINQ monitor if negative 30 day result.
15984852|NCT03001752|Device|Open flap immediate implant|Post-extraction implants will be inserted through open flap, without bone grafting
15984853|NCT03001752|Device|Open flap immediate implant and bone grafting|Post-extraction implants will be inserted through open flap, adding bone grafting
15984854|NCT03001752|Device|Flapless immediate implant|Post-extraction implants will be inserted without elevating flap or inserting bone grafting
15984855|NCT03001739|Drug|Urapidil Hydrochloride Injection|Urapidil Hydrochloride Injection or other antihypertensive agents to decrease the BP to the target level.
15984856|NCT03001726|Procedure|Gastrectomy|In patients assigned to surgery followed by chemo- therapy, a total, distal, or proximal gastrectomy with metastasis dissection was done depending on tumour location.
15984857|NCT03001726|Drug|oxaliplatin|oxaliplatin 100 mg/m2
15984858|NCT03001726|Drug|S1|S1 40mg/m2
15984859|NCT03001726|Drug|Docetaxel|docetaxel 40 mg/m2
15984860|NCT03001713|Behavioral|CV WIZARD|"This project will determine whether a sophisticated CDS system will be effective in CHCs. The innovative, point-of-care, web-based CDS system we will test (CV Wizard) generates a guideline-based prioritized summary of each patient's major CVD risk factors, then presents patient and provider 'views' of this summary, with individualized care recommendations."
15984861|NCT03001700|Device|Serranator™ Alto PTA Serration Balloon Catheter|The Serranator™ is an over-the-wire (OTW) balloon dilatation catheter designed to perform percutaneous transluminal angioplasty (PTA) for peripheral indications.
15984862|NCT03001687|Dietary Supplement|enteral supplementation with vitamin D|"Patients allocated to the vitamin D + group receive enteral supplementation with high-dose vitamin D (250.000UI)"
15984863|NCT03001687|Other|blood collection 3mL|all patients will have hepcidin levels measured in the first 24 hours after admission and one week after
15984864|NCT03001674|Device|Conductance catheterization|CD Leycom Conductance Catheter
15984865|NCT03001661|Device|Dilapan-S|DILAPAN-S® is a non-pharmacological synthetic rod, which is inserted into the cervical canal and through the internal os, for cervical ripening prior to induction. Its mode of action consists in the hydrophilic properties of the device absorbing fluids from surrounding tissue structures, thus expanding the volume of DILAPAN-S® sticks, usually within a 12-hour period. Subsequently it exerts radial pressure on the surrounding structures (cervix) to dilate progressively. Endocervical pressure on the cervix results not only in its mechanical dilatation but the pressure on the endocervical structures also stimulates the production of endogenous PGs and promotes cervical ripening through its collagenolytic action.
15984866|NCT03001661|Drug|Dinoprostone|Dinoprostone slow release 10mg vaginal insert is currently the standard method used for induction of labour in the NHS, particularly in nulliparous woman.
15984867|NCT03001648|Procedure|PGS (Preimplantation Genetic Screening) with trophectoderm biopsy|PGS (Preimplantation Genetic Screening) with trophectoderm biopsy using arrays comparative genomic hybridizatioon (aCGH)
15984868|NCT03001635|Drug|Oxytocin|26 patients will receive Oxytocin infusion for 6h while 26 will receive placebo. all other treatments will be the same and up to date with the current guidelines.
15984869|NCT03001635|Drug|Placebos|26 patients will receive 0.9% normal saline infusion for 6h as placebo
15984870|NCT03001622|Biological|IFX-1|chimeric, monoclonal antibody
15984871|NCT03001609|Drug|AC0010|Oral dose of 14C-labeled AC0010 suspension including 200 mg/83μCi[14C]
15984872|NCT03001596|Procedure|Neoadjuvant Chemoradiotherapy|Before surgery, patients in this group receive neoadjuvant chemoradiotherapy. A total dose of 40 Gy is delivered in 20 fractions (5 fractions per week) for 4 weeks. Chemotherapy is delivered concomitantly and composed of four cycles of paclitaxel 50mg per square meter of body-surface area and cisplatin 25mg per square meter of body-surface area weekly at the intervals of radiotherapy. After neoadjuvant therapy of 4-8 weeks, minimally invasive esophagectomy is performed.
15984873|NCT03001596|Procedure|Neoadjuvant Chemotherapy|Before surgery, patients in this group receive neoadjuvant chemotherapy. Chemotherapy is delivered and composed of two cycles of paclitaxel 135mg per square meter of body-surface area and cisplatin 75mg per square meter of body-surface area every 4 weeks. After neoadjuvant therapy of 4-8 weeks, minimally invasive esophagectomy is performed.
15984874|NCT03001596|Procedure|Minimally Invasive Esophagectomy|After neoadjuvant therapy, patients in groups receive minimally invasive esophagectomy
15984875|NCT03001583|Behavioral|Education program with cooking lessons|Structured education program of mediterranean diet and lifestyle changes with cooking lessons delivered in monthly visits for an induction phase of 6 months, with an extension period of up to two years.
15984876|NCT03001583|Behavioral|Education program WITHOUT cooking lessons|Structured education program of mediterranean diet and lifestyle changes WITHOUT cooking lessons delivered in monthly visits for an induction phase of 6 months, with an extension period of up to two years.
15984877|NCT03001570|Drug|Cetuximab plus Radiotherapy|Standard dose of a curative radiotherapy treatment is 70Gy given with conventional fractionation (2G daily) in an overall length of 7 weeks. In this study, the fractionation has been modified accordingly Cetuximab pharmacokinetics. Cetuximab will be administered with standard schedule: charge dose of 400mg/mq a week before the beginning of concurrent treatment, then weekly doses of 250mg/mq intravenous for 7 administration. This schedule to obtain the same biological efficacy on tumour with lower toxicity on healthy tissues.
15984878|NCT03001557|Drug|Lemborexant 2.5 mg|Lemborexant 2.5 mg tablets
15984879|NCT03001557|Drug|Lemborexant 5 mg|Lemborexant 5 mg tablets
15984880|NCT03001557|Drug|Lemborexant 10 mg|Lemborexant 10 mg tablets
15984881|NCT03001557|Drug|Lemborexant 15 mg|Lemborexant 5 mg and 10 mg tablets
15984882|NCT03001557|Drug|Lemborexant-matched placebo|Lemborexant-matched placebo tablets
15984883|NCT03001544|Biological|TS23|comparison of different doses
15984884|NCT03001531|Device|HydroSun|a skin area of the lower limb will be treated three times with ultraviolet light emitted by a halogen lamp
15984885|NCT03001531|Device|Hilotherm|a skin area of the lower limb will be treated three times with heat applied by a sleeve
15984886|NCT03001479|Dietary Supplement|Similac Human Milk Fortifier Hydrolyzed Protein Concentrated Liquid|HMF with additional hydrolyzed protein
15984887|NCT03001466|Drug|urea-loaded nanoparticles eye drops|one drop five times a day for 8 weeks
15984888|NCT03001466|Drug|Balance Salt Solution eye drops|one drop five times a day for 8 weeks
15984889|NCT03001453|Drug|Liposomal Bupivacaine|266mg liposomal bupivacaine
15984890|NCT03001453|Drug|0.25% Bupivacaine with epinephrine|0.25% bupivacaine with epinephrine
15984891|NCT03001453|Drug|Saline|Normal saline
15984892|NCT03001440|Other|KAB survey|The KAB survey will be conducted among study population to evaluate their understanding of the potential serious risk with the use of ZYBAN. The 20 minutes survey can be completed either online or through a telephone interview.
15984893|NCT03001427|Behavioral|Structured center-based lifestyle intervention|
15984894|NCT03001427|Behavioral|Standard education and physician advice|
15984895|NCT03001414|Biological|Placebo followed by Autologous EPCs transfected with human eNOS|4 doses of placebo in first 6 months followed by 4 doses of autologous EPCs transfected with eNOS in second 6 months
15984896|NCT03001414|Biological|Autologous EPCs transfected with human eNOS followed by Placebo|4 doses of autologous EPCs transfected with eNOS in first 6 months followed by 4 doses of placebo in second 6 months
15984897|NCT03001414|Biological|Autologous EPCs transfected with human eNOS|4 doses of autologous EPCs transfected with eNOS in first 6 months which is repeated in second 6 months
15984898|NCT03001401|Other|iDesign|One group will under go standard LASIK using iDesign platform (J&J, USA). Visual acuity, tomography outcomes, biomechanical outcomes and inflammation in myopic eyes treated with iDesign and SMILE are proposed to be evaluated under the study.
15984899|NCT03001401|Other|SMILE|The other group will undergo SMILE for treatment refractive error (Carl Zeiss, Germany). isual acuity, tomography outcomes, biomechanical outcomes and inflammation in myopic eyes treated with iDesign and SMILE are proposed to be evaluated under the study.
15984900|NCT03001388|Procedure|Transient Elastography (TE)|Participants enrolled in Cystic Fibrosis Liver Disease Network (CFLD NET)Prediction by Ultrasound of the Risk of Hepatic Cirrhosis in Cystic Fibrosis (PUSH) study in longitudinal follow up at centers with Fibroscan available (currently 8/11 centers)
15984901|NCT03001375|Procedure|Laparoscopic high anterior resection splenic flexure mobilization|
15984902|NCT03001375|Procedure|Laparoscopic high anterior resection without splenic flexure mobilization|
15984903|NCT03001362|Radiation|Radical external beam radiotherapy|pelvic radiotherapy to a dose of 45 Gy in 25 fractions with a tumor boost to a dose of 9 Gy in 5 fractions (thus total of 54 Gy/30 fractions to the primary tumor), combined with radio sensitizing chemotherapy.
15984904|NCT03001349|Procedure|Computed Tomography|Undergo PET/CT
15984905|NCT03001349|Drug|Gallium Ga 68-Edotreotide|Given IV
15984906|NCT03001349|Procedure|Positron Emission Tomography|Undergo PET/CT
15984907|NCT03001336|Other|no intervention|This is a cross-sectional study
15984908|NCT03001323|Drug|Degludec|"Discharge on once a day degludec insulin by pen (supplied by Novo) at dose 0.3 U/kg with reduction to 0.2 U/kg for GFR <30 ml/hr.
~Fast acting insulin that patient is using will be adjusted so that total daily dose given to cover 2 or 3 meals is equal to the long-acting insulin dose. Patient will have basal bolus regimen either using carb counting or with set doses for meals.
~Insulin adjustment if hypoglycemia (less than 60 mg/dl) or if fasting BG over 140 despite insulin compliance. For hypoglycemia, dose will be lowered 0.05 U/kg and for elevated fasting glucose it will be raised 0.05 U/kg.
~Phone calls every month and clinic visits every 3 months for 1 year with dose adjustment as above."
15984909|NCT03001323|Drug|Standard long-acting|"Discharge on once a day long-acting insulin by pen that patient is using at time of enrollment (supplied by clinic) at dose 0.3 U/kg with reduction to 0.2 U/kg for GFR <30 ml/hr.
~Fast acting insulin that patient is using will be adjusted so that total daily dose given to cover 2 or 3 meals is equal to the long-acting insulin dose. Patient will have basal bolus regimen either using carb counting or with set doses for meals.
~Insulin adjustment if hypoglycemia (less than 60 mg/dl) or if fasting BG over 140 despite insulin compliance. For hypoglycemia, dose will be lowered 0.05 U/kg and for elevated fasting glucose it will be raised 0.05 U/kg.
~Phone calls every month and clinic visits every 3 months for 1 year with dose adjustment as above."
15984910|NCT03001310|Biological|AAV - CNGB3|Comparison of different dosages of AAV-CNGB3
15984911|NCT03001297|Biological|Placebo|Participants will receive single dose of placebo matched MEDI5884 injection SC on Day 1
15984912|NCT03001297|Biological|MEDI5884 Dose 1|Participants will receive single dose MEDI5884 Dose 1 injection SC on Day 1.
15984913|NCT03001297|Biological|MEDI5884 Dose 2|Participants will receive single dose MEDI5884 Dose 2 injection SC on Day 1
15984914|NCT03001297|Biological|MEDI5884 Dose 3|Participants will receive single dose MEDI5884 Dose 3 injection SC on Day 1
15984915|NCT03001297|Biological|MEDI5884 Dose 4|Participants will receive single dose MEDI5884 Dose 4 injection SC on Day 1
15984916|NCT03001284|Other|NO intervention|
15984917|NCT03001271|Drug|Angiotensin 1-7|
15984918|NCT03001271|Other|Placebo|
15984919|NCT03001258|Other|Presbyopia screening training|The training module and the protocol were designed in a way that a layman with limited education could be trained for screening and could sell reading glasses without any hassle, accurately and responsibly. Training module included the general anatomy of eye, common vision problems, aetiologies, determination of proper acuity of vision, sales techniques of the reading glass, marketing of products and services, and management of inventory and referrals. All the providers who participated in the current study, had no prior experience/training of screening presbyopia before the intervention. Each of the intervention arm used letter acuity chart i.e. Snellen chart as it commonly used for as a test of visual acuity
15984920|NCT03001245|Behavioral|Interpersonal Counseling|Interpersonal Counseling 1+6 sessions
15984921|NCT03001245|Behavioral|Standard treatment|Psychosocial treatment 1+6 sessions guided by the professional's standard professional principles and routinely available methods
15984922|NCT03001232|Behavioral|Movement-oriented Dementia Care|The intervention is a new multidisciplinary approach that focuses on optimizing physical activity and independence in daily care and activities. MDC intended to incorporate all persons surrounding the patients. The nursing staff was intensively trained by an expert in MDC, and played a central role in continuously stimulating patients to function as independently as possible. Geriatric physicians and physiotherapists advised the nursing staff about participants' medical and physical limitations to ensure safe stimulation. Consequently, a plan was created for each resident to determine the daily routines they were capable of performing themselves. Caregivers and volunteers were informed about the benefits of an active lifestyle during several open meetings.
15984923|NCT03001219|Drug|Anti-TNF-alpha|Participants will continue their pre-trial anti-TNF-alpha therapy at a stable dose.
15984924|NCT03001219|Drug|Methotrexate|Participants will continue their pre-trial methotrexate therapy at a stable dose.
15984925|NCT03001219|Drug|Placebo|Participants will receive intravenous infusion of placebo.
15984926|NCT03001219|Drug|RO7123520|Participants will receive intravenous infusion of RO7123520.
15984927|NCT03001206|Device|Master Caution System|"The purpose of this study is to evaluate the effectiveness and usability of the Master Caution System for 12 leads continuous monitoring of ECG signal in the ICCU.
~The purpose of the study is to evaluate the effectiveness and usability of using Master Caution 12 leads Garment for stress test.
~The purpose of the study is to reassess the adequate size of the Master Caution Garment (MCG)."
15984928|NCT03001193|Drug|DF 01|
15984929|NCT03001193|Drug|Oxytocin|
15984930|NCT03001193|Drug|Placebo|
15984931|NCT03001154|Behavioral|Face-to-face Virtual Reality Exposure Therapy|In session, systematic, hierarchical exposure to feared stimuli with therapist.
15984932|NCT03001154|Behavioral|Internet-administered Virtual Reality Exposure Therapy|Therapist-guided, Internet-administered Virtual Reality Exposure Therapy self-help program
15984933|NCT03001154|Other|Waiting-list|Weekly assessments of public speaking
15984934|NCT03001141|Other|Observational|Device: MultiPoint Pacing will be enabled in enrolled patients at the discretion of the physician.
15984935|NCT03001128|Drug|Antiretroviral treatment pause|Antiretroviral treatment pause
15984936|NCT03001102|Device|4% Chlorhexidine gluconate|Cationic biguanide - antimicrobial action rubbing in the skin.
15984937|NCT03001102|Device|10% PVPI degermante|Polymer soluble in water of iodine with polyvinylpyrrolidone (PVP) - antimicrobial action rubbing in the skin.
15984938|NCT03001102|Device|Soap without antiseptic|Liquid soap with glycerin, neutral pH. Skin cleansing
15984939|NCT03001089|Drug|Oral Fludrocortisone (enteral)|Oral Fludrocortisone (enteral) at a dose of 10 mcg 2 times daily (every 12 hours) for 8 days from day 1 (first administration between H24 and H30, and then every 12 hours) until day 8.
15984940|NCT03001089|Drug|Placebo Oral Tablet|oral placebo (enteral) at a dose of 10 mcg 2 times daily (every 12 hours) for 8 days from day 1 (first administration between H24 and H30, and then every 12 hours) until day 8.
15984941|NCT03001076|Drug|Bempedoic acid|bempedoic acid 180 mg tablet
15984942|NCT03001076|Drug|Ezetimibe|ezetimibe 10 mg tablet
15984943|NCT03001076|Other|Placebo|matching placebo tablet
15984944|NCT03001063|Other|Supported Self-Management|This Supported Self-Management intervention consists of bibliotherapy (the Antidepressant Skills Workshop) that is provided to a patient by a health or social worker. The patient is supported in the use of the skills found in the workbook over the course of two months. The skills in the workbook are based on the principles of Cognitive Behavioural Therapy.
15984945|NCT03001063|Other|Enhanced treatment as usual|Participants in the control arm will received enhanced treatment as usual in the form of usual care at primary care centres and a leaflet providing information about depression.
15984946|NCT03001050|Device|PINPOINT System|To use the camera probe and identify the tendon and footprint vascularity at the time of surgery
15984947|NCT03001024|Behavioral|Implementation of WayToServe Español|Following baseline assessment and randomization to experimental condition, premises assigned to the intervention condition will be contacted and recruited to the trial. Managers will provide a list of all servers. All servers will be registered by project staff on the WTS-E website and provided a unique identification code, which will track their use of the training and associate it with the premise. Servers will complete a profile on the program during their first login. Servers will be asked to complete the training within four weeks from initial registration; email and text reminders will be sent to those who do not login within one week of initial registration.
15984948|NCT03001024|Behavioral|Usual and Customary RBS Training|The premises randomized to the UC training condition will be, in effect, blind to the investigation. Server training is mandatory for all servers in New Mexico. Server training is voluntary in Texas but heavily incentivized by TABC's Safe Harbor clause. Under this clause, liquor licensees are held harmless for any service infractions if all servers are trained and certified by an approved RBS trainer; instead, the server is cited for the infraction.
15984949|NCT03001011|Drug|Placebo|"Pharmaceutical form: tablet
~Route of administration: oral"
15984950|NCT03001011|Drug|Sevelamer Carbonate (GZ419831)|"Pharmaceutical form: tablet
~Route of administration: oral"
15984951|NCT03000998|Behavioral|Web App Intervention Group|All baseline and follow-up data collection will be conducted via online surveys and a customized web portal and include parent self-reports and clinic records of vaccination of boys
15984952|NCT03000998|Behavioral|Usual Customary Care Group|Participants randomized to the usual and customary care (UC) group will receive a website with a pamphlet on HPV vaccination from the Centers for Disease Control and Prevention (CDC) in Portable Document Format (PDF) format.
15984953|NCT03000985|Behavioral|Psychoeducation|6 session psychoeducation program with the family caregiver of schizophrenics patients.
15984954|NCT03000972|Procedure|Cement augmentation|
15984955|NCT03000972|Procedure|PFN-A Nail|
15984956|NCT03000946|Drug|Somatostatin|Lyophilisate and solution for IV use (glass ampoule of lyophilisate + 1 ml glass ampoule of solvent) 6 mg per day Continuous intravenous infusion for 6,5 days
15984957|NCT03000946|Drug|Octreotide|Solution for Subcutaneous use 100μg, every 8 hours Subcutaneous injection for 6,5 days
15984958|NCT03000920|Other|SMS before invitation|A couple of days before the invitation letter, an SMS will be sent to announce the arrival of the invitation letter to the mammogram
15984959|NCT03000920|Other|SMS Reminder 1|If it is necessary for the women to have a reminder 1, the usual mail will be replaced by an SMS.
15984960|NCT03000907|Other|Intervention|Diet and physical exercises
15984961|NCT03000894|Behavioral|Cognitive Behavioral Therapy for Insomnia (CBT-I)|This CBT-I is a 4 sessions 60-90 minutes group-based therapy administered by a nurse therapist. Each session has 6-8 participants.
15984962|NCT03000881|Other|standard adhesive|This is a standard adhesive (hydrocolloid)
15984963|NCT03000881|Other|New adhesive strip|This is a newly developed adhesive strip
15984964|NCT03000868|Procedure|Cold endoscopic mucosal resection|Cold endoscopic mucosal resection (EMR) means removing small colorectal polyps (<1cm) with snare without the use of electocautery after injection of normal saline into the submucosa.
15984965|NCT03000868|Procedure|Hot endoscopic mucosal resection|Hot endoscopic mucosal resection (EMR) means removing small colorectalpolyps (<1cm) with snare without the use of electocautery after injection of normal saline into the submucosa.
15984966|NCT03000855|Procedure|EUS-guided choledocho-duodenostomy|"The CBD would be identified by a linear echoendoscope and a suitable puncture site in the bulb of the duodenum would be located. The common bile duct would be punctured with a 19-gauge needle and the position would be confirmed by aspiration of bile and contrast injection. A 0.025 or 0.035 guide wire would be passed through the needle in to the CBD. A fully covered metal stent would then be inserted after track dilation."
15984967|NCT03000855|Procedure|Endoscopic retrograde cholangiopancreatography with covered metallic stent|After cannulation of the CBD, a cholangiography would be performed to assess the diameter of the CBD, the length and position of the biliary stricture. The endoscopist would decide on the appropriate size of SEMS to be placed. The stents should be visible from the duodenal lumen after deployment.
15984968|NCT03000842|Device|transcutaneous vagal nerve stimulation on|electrical current on positioned in the ear to estimate vagal branch of auricular nerve
15984969|NCT03000842|Device|transcutaneous vagal nerve stimulation off|an electrical current off positioned in the ear to estimate vagal branch of auricular nerve
15984972|NCT03000816|Radiation|SBRT|Patients with 1-4 metastases located in less than 2 organs/ lymphatic drainage regions that are 5 cm or less from each other and simultaneously treated with SBRT.
15984973|NCT03000803|Behavioral|Early Total Caloric Intake|Provide subjects a regimented amount of calories at each meal.
15984974|NCT03000803|Behavioral|Late Total Caloric Intake|Provide subjects a regimented amount of calories at each meal.
15984975|NCT03000790|Device|Lingual Ring Splint|"A polyvinyl (polypropylene) material was chosen, which is biocompatible, nontoxic, hypoallergenic, and has a hardness of about 60-70 Shore, The thickness of 3 mm in the occlusive active portion and 2 mm in the other parts was constructed.
~The lingual ring consists of Two lateral genal shields that are vertical and symmetric, and have a right- and left-of-oval form, Two interocclusive levels with a roughly triangular form, but with round angles also right and left symmetric, double arch superior arch and inferior archwill make the Ring around the tongue"
15984976|NCT03000777|Dietary Supplement|melatonin plus zinc|Melatonin 1 mg plus Zinc 10 mg o.d. 1 hour before going to bed during 16 weeks
15984977|NCT03000777|Other|Placebo|Isomaltose o.d. 1 hour before going to bed during 16 weeks
15984978|NCT03000764|Other|skin biopsies|"Biopsies (12 G) will be performed :
~in non-irradiated breast skin
~in irradiated breast skin"
15984979|NCT03000764|Other|blood samples|"blood samples are collected:
~10 ml in EDTA tube
~2,5 ml in PAXgene Blood RNA tube
~4 ml in EDTA tube"
15984980|NCT03000751|Other|Simple Audit Report|The simple audit provides comparison and feedback on radiation doses.
15984981|NCT03000751|Other|Multi-Component Intervention|The multi-component intervention gives tailored feedback on needed changes plus guidance using quality improvement methods that facilitate organizational change. Provides access to experts, detailed audit, collaborative calls, and site visits (as needed).
15984982|NCT03000751|Other|In-Person Meeting|Collaborator meeting with an emphasis on quality improvement.
15984983|NCT03000725|Behavioral|Using Practice and Learning to Increase Favorable Thoughts|"Description of the UPLIFT program: Participants who choose to participate in UPLIFT will complete 8 weekly group sessions via telephone.
~Session 1: Introduction to UPLIFT/Noticing Thoughts Session 2: Checking and Changing Thoughts Session 3: Coping & Relaxing Session 4: Attention & Mindfulness Session 5: The Present as a Calm Place Session 6: Thoughts as Changeable, Thoughts as Not Fixed Session 7: Focus on Pleasure & the Importance of Reinforcement Session 8: Preventing Lapses and Giving Thanks"
15984984|NCT03000725|Behavioral|Usual Care|Participants randomized to the UC group will receive printed educational materials on management of epilepsy in English or Spanish as preferred.
15984985|NCT03000712|Biological|Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml|biological : Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml drug: saline solution
15984986|NCT03000699|Behavioral|Cognitive Bias Modification|Training paragraphs describe scenarios designed to be ambiguous at the outset and to resolve in a positive direction, with the intention of establishing a learning contingency between the ambiguity at the beginning of the scenario and the positive resolution that becomes clear towards the end of the statement.
15984987|NCT03000686|Biological|GSK2586881|GSK2586881 will be a clear colorless liquid for IV infusion over 3- 5 mins and will be administered as unit dose 0.8 mg/kg.
15984988|NCT03000686|Other|Placebo|Normal saline (0.9%) will be administered as a single IV dose infusion over 3 to 5 min.
15984989|NCT03000673|Drug|Enoxaparin|Specified dose of Enoxaparin on specified days
15984990|NCT03000673|Drug|unfractionated heparin (UFH)|Specified dose of UFH on specified days
15984991|NCT03000673|Drug|BMS-986177|Specified dose of BMS-986177 on specified day
15984992|NCT03000660|Drug|Venetoclax|Venetoclax at one of four escalating doses
15984993|NCT03000660|Drug|Dexamethasone|Dexamethasone 20mg by mouth on days 1, 8, 15, and 22 of each cycle.
15984994|NCT03000647|Procedure|Pelvic floor exercises guided by a physiotherapist|Subjects perform two types of contractions of the pelvic floor in two different positions 3 times a day and once a week they check it with a physiotherapist (this day only they do it twice at home)
15984995|NCT03000647|Procedure|Non guided pelvic floor exercises|Subjects perform two types of contractions of the pelvic floor in two different positions 3 times a day. They do not attend to meetings with a physiotherapist
15984996|NCT03000634|Drug|Elotuzumab|Administered through a small tube that goes directly into the vein
15984997|NCT03000634|Drug|Bortezomib|Administered as a subcutaneous injection under the skin
15984998|NCT03000634|Drug|Lenalidomide|Capsule taken by mouth
15984999|NCT03000634|Drug|Dexamethasone|Taken by mouth
15985000|NCT03000608|Drug|SAN021 Serum|SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.
15985122|NCT02999633|Drug|dexamethasone|Pharmaceutical form:pills Route of administration: oral
15985123|NCT02999633|Drug|dexamethasone|Pharmaceutical form:solution Route of administration: intravenous
15985001|NCT03000608|Drug|SAN021 Placebo|SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.
15985002|NCT03000595|Drug|SAN007 Cream|A cream containing 5% East Indian sandalwood oil (EISO).
15985003|NCT03000595|Drug|Placebo|The vehicle cream
15985004|NCT03000582|Dietary Supplement|Creatine monohydrate|Creatine monohydrate (5.0 g creatine monohydrate, 1.5 g dextrose)
15985005|NCT03000582|Dietary Supplement|Creatine nitrate-1|Creatine nitrate-1 (1.0 g creatine monohydrate, 0.5 g nitrate, 5.0 g dextrose)
15985006|NCT03000582|Dietary Supplement|Creatine nitrate-2|Creatine nitrate-2 (2.0 g creatine monohydrate, 1.0 g nitrate, 3.5 g dextrose)
15985007|NCT03000582|Dietary Supplement|Placebo|Placebo (6.5 g dextrose)
15985008|NCT03000569|Drug|SAGE-217|
15985009|NCT03000569|Drug|Levodopa|Levodopa (including carbidopa-levodopa) administered as antiparkinsonian agent(s).
15985010|NCT03000569|Drug|Antiparkinsonian Agent(s)|Antiparkinsonian agent(s) were administered as a clinical practice as standard of care, which includes levodopa (i.e. levodopa/carbidopa) or dopamine agonists or catechol-O-methyltransferase (COMT) inhibitors or monoamine oxidase (BMAO-B) inhibitors.
15985011|NCT03000556|Drug|0.3% Sodium Hyaluronate Eye Drop|The patients need to use 0.3% Sodium Hyaluronate Eye Drop for 3 month.
15985012|NCT03000543|Biological|Vaccine|Pentavalent vaccine. It is a combination of five different antigens (Hepatitis B (HBV)/ Haemophilus influenzae type b (HiB) / Tetanus-Diphtheria-whole cell Pertussis (TDwP)).
15985013|NCT03000530|Drug|SAGE-217|
15985014|NCT03000530|Drug|Placebo|
15985015|NCT03000504|Device|Ballooned intercostal drain|Patients will have a Rocket Medical 16F ballooned intercostal drain inserted as per usual clinical guidelines. No other change to treatment will be made, and the drain is inserted in exactly the same way as a standard drain, using the Seldinger technique.
15985016|NCT03000491|Other|No intervention|
15985017|NCT03000478|Behavioral|Prolonged Exposure|
15985018|NCT03000478|Behavioral|Virtual Reality Exposure Therapy|
15985019|NCT03000465|Procedure|Laparoscopic colorectal surgery|Minimizing intra-abdominal insufflation pressure in laparoscopic colorectal surgery as an individualized strategy
15985020|NCT03000452|Drug|DARATUMUMAB|DARATUMUMAB
15985021|NCT03000452|Drug|DURVALUMAB|DURVALUMAB
15985024|NCT03000426|Procedure|Free gingival graft|Free gingival graft removal from palate for socket preservation
15985025|NCT03000426|Device|GaAlAs laser|Utilization of GaAlAs laser to irradiation on the palatal donor site for photobiomodulation
15985026|NCT03000413|Drug|Ketamine|Active treatment
15985027|NCT03000413|Drug|Fentanyl|
15985028|NCT03000400|Behavioral|The Traumatic Brain Injury Family System Intervention.|Theoretically based intervention consisting of 8 weekly 90 minutes sessions addressing specific topics according to a manual.
15985029|NCT03000400|Behavioral|Psycho-educational session at OUH|2.5 hour psycho-educational session for the patient's family members.
15985030|NCT03000387|Drug|Nicotine Patch|Active nicotine patch of 21 mg, 14 mg and 7 mg
15985031|NCT03000387|Drug|Placebos|Matching placebo patches of 21 mg, 14 mg and 7 mg
15985032|NCT03000374|Drug|Panitumumab|Panitumumab will be administered intravenously (IV) in a dose of 6 mg/kg on day 1 every 14 days. Panitumumab will be supplied to sites by the study sponsor in 5-mL and 20-mL vials, at a concentration of 20 mg/mL.
15985033|NCT03000374|Drug|5Fluorouracil|Once every 14 days. Day 1: 400 mg/m2 in IV bolus and a 46-hour infusion of 5-FU 2400 mg/m².
15985034|NCT03000374|Drug|Oxaliplatin|Once every 14 days. Day 1: 85 mg/m2 I.V. infusión in 250-500 mL, over two hours, followed by 5-FU
15985035|NCT03000374|Drug|Leucovorin|Once every 14 days. Day 1: 200 mg/m2 I.V., over two hours, followed by 5-FU
15985036|NCT03000361|Procedure|Motorized Spiral Colonoscopy|For any pathological finding during colonoscopy standard endoscopic techniques, e.g. forceps biopsy, injection, endoscopic mucosal resection, argon plasma coagulation
15985037|NCT03000348|Drug|Cysteamine|Oral Cysteamine Capsule
15985038|NCT03000348|Drug|Placebo Oral Capsule|Placebo Oral Capsule
15985039|NCT03000322|Device|Cooling Vest|A cool therapy device intended to provide moderate, controlled cooling (approximately 15C/59F) by absorbing heat. The material in the vest is safe, non-toxic, and eco-friendly.
15985040|NCT03000309|Drug|Apremilast|
15985041|NCT03000296|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Hematopoietic stem cell transplantation Lymphoablation followed by hematopoietic stem cell transplantation to rescue the immune system.
15985042|NCT03000283|Drug|Conivaptan|"Patients will receive 20mg IV of the study drug every 12 hours equaling 40mg/day over 2 days (4 doses total), in addition to the standardized ICH management targets using the PI's version of standardized ICH management targets.Usual standard of care can include sedation and analgesia as needed, elevation of the head of the bed, mannitol and/or saline as needed to reduce ICP, and temperature control with antipyretics such as acetaminophen.
~The conivaptan bolus (20mg), which is premixed with 100ml of 5% dextrose in water, is infused (peripherally) over 30 minutes, most commonly through an already placed central line."
15985043|NCT03000270|Device|Impella unloading prior to PPCI|Impella unloading prior to PPCI
15985044|NCT03000257|Drug|Venetoclax|Tablet taken orally
15985045|NCT03000257|Drug|Rovalpituzumab Tesirine|Intravenous infusion
15985046|NCT03000257|Drug|ABBV-181|Intravenous infusion
15985047|NCT03000218|Drug|Ursodeoxycholic acid|Ursodeoxycholic acid 300mg bid for 8 weeks
15985048|NCT03000218|Drug|Metformin|Day 29 to 56: Metformin 500mg bid
15985049|NCT03000218|Drug|Placebo|Day 1 to 56: Placebo bid
15985050|NCT03000205|Device|hypertonic dextrose water|20% hypertonic dextrose water injection for chronic shoulder pain at Week0
15985051|NCT03000205|Device|Normal saline and Lidocaine.|Normal Saline injection for chronic shoulder pain at Week0 (Arms:Placebo Comparator: Placebo)
15985124|NCT02999633|Drug|acetaminophen|Pharmaceutical form:pills Route of administration: oral
15985053|NCT03000166|Behavioral|Step-Up Intervention|Intervention group participants will meet with a study facilitator during 5 regularly scheduled visits for chemotherapy. The facilitator will provide education about the benefits of physical activity and strategies to overcome barriers to physical activity, help the participants to set physical activity goals based on ability and preferences, and educate the participant on using a physical activity tracker.
15985054|NCT03000153|Other|Completing the Goals Form|The Goals Form is a personalised outcome measure where clients enter their goals in collaboration with their assessor. Goals are then rated at the start of every session and open the therapeutic dialogue.
15985055|NCT03000140|Behavioral|High Intensity Interval Training|High Intensity Interval Training pre-hypertensive group; Exercise will be performed at three sessions per week. All sessions will be supervised by an exercise physiologist during 16 weeks.
15985056|NCT03000140|Behavioral|Control group|Moderade Intensity Interval Training pre-hypertensive group; Exercise will be performed at three sessions per week. All sessions will be supervised by an exercise physiologist during 16 weeks.
15985057|NCT03000127|Drug|AndroGel 1 % Topical Gel|testosterone gel
15985058|NCT03000127|Drug|Placebos|Placebo gel
15985059|NCT03000114|Procedure|Percutaneous Needle Aponeurotomy|
15985060|NCT03000114|Drug|XIAFLEX|
15985061|NCT03000101|Other|100% pomegranate juice|125 mL of 100% pomegranate juice twice daily for 12 weeks
15985062|NCT03000101|Other|placebo beverage|125 mL of placebo beverage twice daily for 12 weeks
15985063|NCT03000088|Device|intubate with 60° angled stylet|
15985064|NCT03000088|Device|intubate with 60° angled stylet|
15985065|NCT03000075|Drug|risankizumab|Risankizumab pre-filled syringe, administered by subcutaneous (SC) injection
15985066|NCT03000075|Drug|placebo for risankizumab|Placebo for risankizumab pre-filled syringe, administered by subcutaneous (SC) injection
15985067|NCT03000062|Behavioral|Intervention group|Please see the preceding section
15985068|NCT03000049|Other|bedside blood culture|
15985069|NCT03000036|Drug|Doxorubicin|Patients had prescribed endovenous doxorubicin as part of their chemotherapy regimen (mean cumulative dose 102,66 mg/m2, administered in 4 doses with 21 days interval).
15985070|NCT03000036|Device|Achieva, Philips Medical Systems (3T magnet)|Patients were imaged in supine position in a 3T magnet (Achieva, Philips Medical Systems, Best, The Netherlands). The protocol consisted of electrocardiographically gated cine imaging with steady state free-precession to assess left ventricular (LV) ejection fraction and LV mass. For imaging of late gadolinium-DTPA enhancement (LGE) we used an inversion-recovery-prepared, gradient-echo sequence with segmented acquisition, which was triggered every other heartbeat. LGE images were acquired during end-expiratory breath-holding, after administration of Dotarem. T1 was performed with a Look-Locker sequence with a non-slice-selective adiabatic inversion pulse, followed by segmented gradient-echo acquisition for 17 times after inversion, covering approximately two cardiac cycles. T1 imaging was repeated in the same LV short-axis slice, once before and five to seven times after the injection of gadolinium to cover an approximately 30-min period of slow contrast clearance.
15985071|NCT03000036|Drug|Gadoterate Meglumine|LGE images were acquired starting within 10 min after bolus administration of a cumulative dose of 0.2 mmol/Kg of gadoterate meglumine (Dotarem, Guerbet, Aulnay-sous-Bois, France).
15985072|NCT03000010|Device|Incisional Wound Vac|
15985073|NCT03000010|Other|Standard Bandage|
15985074|NCT02999997|Behavioral|Ronnie Gardiner Method (RGM)|RGM includes functional exercises consisting of cognitively challenging multi-task exercises. The exercises are performed sitting down or standing up with weight shifting exercises. The practitioner projects unique symbols shaped as red or blue hands and feet on the wall in specific 'choreoscores' of 2-8 bars. Red symbolizes left side of the body, blue the right side. Each symbol is accompanied with a certain movement and sound code. To the sound of rhythmical music the participants follow the symbols beat by beat, performing the movements and pronouncing the word. The exercises are progressed by increasing the tempo of the music, or by using more symbols. The practitioner uses a shirt with the color red on one side, and blue on the other side, in order to facilitate for the participants.
15985075|NCT02999984|Genetic|Infusion of autologous cryopreserved EFS-ADA LV CD34+ cells (OTL-101)|autologous cryopreserved EFS-ADA LV CD34+ cells (OTL-101) are infused intravenously
15985076|NCT02999984|Drug|busulfan|Busulfan is used for non-myoablative conditioning
15985077|NCT02999984|Drug|PEG-ADA ERT|PEG-ADA ERT is discontinued at Day +30 (-3/+15 days) after successful engraftment
15985078|NCT02999971|Other|circuit class therapy in water|The circuit, the main part of the session, include a series of 10 different workstations, arranged to progress in complexity, in order to work several segments of the body, oriented towards a functional recovery objective. These stations will be made up of task-specific activities for gait, balance and dexterity. Time in each workstation will be 5 minutes divided as follows: 4 minutes work period and 1 minute rest period, of these, last 30 seconds will be change period for crossing from one workstation to the next. After 50 minutes, each patient will have covered the 10 workstations, thus working in all of the objectives pursued in the realization on this CCT: gait, balance and dexterity.
15985079|NCT02999971|Other|circuit class therapy on land|The circuit, the main part of the session, include a series of 10 different workstations, arranged to progress in complexity, in order to work several segments of the body, oriented towards a functional recovery objective. These stations will be made up of task-specific activities for gait, balance and dexterity. Time in each workstation will be 5 minutes divided as follows: 4 minutes work period and 1 minute rest period, of these, last 30 seconds will be change period for crossing from one workstation to the next. After 50 minutes, each patient will have covered the 10 workstations, thus working in all of the objectives pursued in the realization on this CCT: gait, balance and dexterity.
15985080|NCT02999958|Biological|Antioxidants|In the Treatment Arm, the G-Series culture media system will be used with antioxidants
15985081|NCT02999945|Dietary Supplement|SGA-enhanced nutrients|Infants will receive fortified breast milk (>50% meals/d fortified, 1,4 g protein, 85 kcal/100ml, FM85, Nestle ®) or post discharge formula (2g protein; 73-75 kcal/100ml; Aptamil PDF, Milupa® or Beba F Nestle® ) between discharge and 52nd week of gestation (three months after term
15985082|NCT02999945|Dietary Supplement|IUGR-enhanced nutrients|Infants will receive fortified breast milk (>50% meals/d fortified, 1,4 g protein, 85 kcal/100ml, FM85, Nestle ®) or post discharge formula (2g protein; 73-75 kcal/100ml; Aptamil PDF, Milupa® or Beba F Nestle® ) between discharge and 52nd week of gestation (three months after term
15985083|NCT02999945|Other|SGA-standard nutrients|Infants will receive unfortified breast milk (65-70kcal/100ml) or starter formula (1,2- 1,3g protein, 66 kcal/100ml Beba Pre Pro Start, Nestle® or Aptamil Pre, Milupa ®) between discharge and 52nd week of gestation (three months after term)
15985084|NCT02999945|Other|IUGR-standard nutrients|Infants will receive unfortified breast milk (65-70kcal/100ml) or starter formula (1,2- 1,3g protein, 66 kcal/100ml Beba Pre Pro Start, Nestle® or Aptamil Pre, Milupa ®) between discharge and 52nd week of gestation (three months after term)
15985085|NCT02999932|Other|SpO2 directed oxygen therapy|Oxygen therapy was administered to achieve targeted SpO2.
15985086|NCT02999919|Procedure|spinal anesthesia|12.5 mg hyperbaric bupivacaine intrathecally following a successful dural puncture performed with a 27G Quincke spinal needle at the L3-4 or L4-5 intervertebral space in the sitting position
15985087|NCT02999906|Drug|Oral Treprostinil|Sustained release oral tablets for three times daily administration
15985088|NCT02999906|Drug|Placebo|Placebo (sugar pill) for three times daily oral administration
15985089|NCT02999893|Drug|APR-246|APR-246 (also known as PRIMA-1MET), a first-in-class agent targeting mutant p53 resulting in re-expression of wild-type p53 activity.
15985090|NCT02999880|Procedure|Polychromatic layering|Only two composite resin material shades will be used (opaque dentine composite and enamel shade composite).
15985091|NCT02999867|Dietary Supplement|triticale and mung bean|subjects are assigned to intake of triticale and mung bean for 30 days
15985092|NCT02999867|Dietary Supplement|adzuki bean|subjects are assigned to intake of adzuki bean for 30 days
15985093|NCT02999854|Biological|ATIR101|ATIR101 is a T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells using photodynamic treatment; single dose of 2×10E6 viable T-cells/kg body weight between 28 and 32 days after the HSCT (intravenous infusion)
15985094|NCT02999854|Drug|Cyclophosphamide|High dose post-transplant cyclophosphamide 50 mg/kg/day at 3 and 4/5 days after the HSCT (powder for intravenous infusion)
15985095|NCT02999854|Procedure|T-cell depleted HSCT from a related, haploidentical donor|T-cell depleted graft prepared from peripheral blood stem cells using the CD34+ cell selection method; infused after a total body irradiation (TBI) or non-TBI conditioning regimen
15985096|NCT02999854|Procedure|T-cell replete HSCT from a related, haploidentical donor|T-cell replete (full, non-manipulated) graft prepared from either bone marrow or peripheral blood stem cells; infused after a total body irradiation (TBI) or non-TBI conditioning regimen
15985097|NCT02999841|Drug|Acarbose|1-2 week: 50mg tid; 3-24 week: 100mg tid.
15985098|NCT02999841|Drug|Vildagliptin|1-24 week: 50mg bid
15985099|NCT02999828|Biological|inactivated EV71 vaccine (KMB-17)|3.0EU of inactivated enterovirus 71 vaccine (KMB-17) on day 0, 28.
15985100|NCT02999815|Procedure|Human tetanus immunoglobulin|Adults admitted to ICU at Hospital for Tropical Diseases will be randomized to receive either human (3000 IU) or equine (21,000 units) intramuscular antitoxin. Second, participants will be randomized to receive the addition of 500 IU intrathecal human antitoxin.
15985101|NCT02999815|Procedure|Intramuscular antitoxin|First, adults admitted to ICU at Hospital for Tropical Diseases will be randomized to receive either human (3000 IU) or equine (21,000 units) intramuscular antitoxin including a 0.05ml test dose (ie 75 units equine antitoxin or 12.5 IU human antitoxin). Second, participants will be randomized with sham procedure
15985102|NCT02999802|Behavioral|Exercise|Progressive resistance exercise training
15985103|NCT02999789|Device|SmartInhaler with reminder function turned on|The SmartInhaler is a medication monitoring system that functions as a patient reminder device. It monitors asthma medication adherence and also functions by providing an audiovisual reminder.
15985104|NCT02999789|Device|SmartInhaler|The SmartInhaler is a medication monitoring system manufactured by Adherium that also functions as a patient reminder device. It monitors asthma medication adherence and also functions by providing an audiovisual reminder.
15985105|NCT02999776|Device|Laser microporation alone|The Er:YAG laser induced microporation of 5 cm2 of a plaque surface, followed by application of an OpSiteTM Flexigrid Transparent Dressing for 4 hours. This treatment will also be repeated twice weekly for 8 weeks.
15985106|NCT02999776|Drug|Standard of care-daily administration of Daivobet|The other control treatment is Daivobet®, which is applied topically daily for 8 weeks on one pre-selected randomized plaque.
15985107|NCT02999776|Drug|Laser microporation + topical application of Etanercept|Immediately following microporation of a 5 cm² area of the designated plaque with the P.L.E.A.S.E.® Professional laser, 0.0625 ml of Etanercept (50 mg/ml) solution for injection in pre-filled syringes will be applied to the microporated surface of the lesion. The treated area will then be covered with OpSiteTM Flexigrid Transparent Dressing for 4 hours. This treatment procedure will be repeated twice weekly for 8 weeks.
15985108|NCT02999763|Device|SlimShape|SlimShape radiofrequency treatment to the abdomen
15985109|NCT02999750|Other|individual therapy|Patient will be treated with individual therapy.
15985110|NCT02999737|Biological|Platelet Rich Plasma for 4 sessions|Injection of autologous platelet rich plasma into areas of alopecia on the scalp every month x 3 sessions then every 3 months x 1 session (total 4 sessions)
15985111|NCT02999737|Biological|Platelet rich plasma for 2 sessions|Injection of autologous platelet rich plasma into areas of alopecia on the scalp every 3 months x 2 sessions (total 2 sessions)
15985112|NCT02999724|Drug|Gabapentin|Gabapentin 300-600 mg 1 hour preop
15985113|NCT02999724|Other|placebo|placebo capsule(s) 1 hour preop
15985114|NCT02999711|Drug|REGN3500|REGN3500 dose
15985115|NCT02999711|Drug|Placebo|Matching placebo
15985116|NCT02999698|Other|Observational|Observational
15985117|NCT02999685|Behavioral|Home-base Pulmonary Rehab with Health Coaching|
15985118|NCT02999672|Drug|Trastuzumab Emtansine|Trastuzumab emtansine will be administered as Regimen A (2.4 mg/kg qw via IV infusion) or Regimen B (3.6 mg/kg q3w via IV infusion) until unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first.
15985119|NCT02999659|Device|Pupilometer|Device to measure change in pupil diameter due to a defined light stimulus.
15985120|NCT02999646|Other|MVX-ONCO-1|Autologous cells: 1 vial containing 4x10^6 irradiated tumor cells Capsules: 2 biocompatible capsules loaded with 8x10^5 MVX-1 cells
15985121|NCT02999633|Drug|Isatuximab SAR650984|Pharmaceutical form:solution Route of administration: intravenous
15985125|NCT02999633|Drug|ranitidine|Pharmaceutical form:solution Route of administration: intravenous
15985126|NCT02999633|Drug|diphenhydramine|Pharmaceutical form:solution Route of administration: intravenous
15985127|NCT02999620|Dietary Supplement|Alpha-cyclodextrin|Alpha-cyclodextrin (α-CD) is a soluble dietary fiber that has a history of use in foods and as a pharmaceutical excipient. Recently the ability of the fiber to bind to dietary fat has led to further investigation of the possible health benefits of dietary supplementation with this fiber.
15985128|NCT02999620|Dietary Supplement|Placebo|Identical looking placebo tablet to active (Alpha-cyclodextrin)
15985129|NCT02999607|Other|transcranial direct current stimulation|0.5 mA, 1mA, 2mA for 10 minutes each
15985130|NCT02999594|Drug|Tramadol Hydrochloride|50mg intramuscularly
15985131|NCT02999594|Drug|Distilled Water|2ml intramuscularly
15985132|NCT02999581|Dietary Supplement|C4 Extreme, C4 Extreme (without Advantra Z)|
15985133|NCT02999568|Other|Physical exercise|Women who practice high level of physical activity, as defined by International Physical Activity Questionnaire, for the past 3 years will be recruited. These women will will be asked to fulfill the International Physical Activity Questionnaire and additional questionnaire regarding relevant demographic and medical information. Blood samples to anti-mullerian hormone , leptin, and hormonal profile will be obtained in day 3 of menstruation. Ultrasound will be performed to measure Antral Follicular count and ovarian blood flow
15985134|NCT02999555|Procedure|Ovum pickup|Ovum pickup or Egg retrieval, that is performed not for the purpose of the study, but for the purpose of well known in vitro fertilization indications
15985135|NCT02999542|Other|Music|Children will be randomised to receive either music via headphones or silence via headphones
15985136|NCT02999542|Other|No music|Children will be randomised to receive either music via headphones or silence via headphones
15985137|NCT02999529|Other|Educational Video|Participants will be asked if they know the meaning of six words related to cancer treatment. Following the interview, participants will watch a video explaining the meaning of the six words. After viewing the video, participants will be re-interviewed about the meaning of the six words.
15985138|NCT02999516|Other|Motor imaginary|Participants imagine doing a motor task watching a video recording
15985139|NCT02999516|Other|Non Motor imaginary|Participants watch a television documentary
15985140|NCT02999516|Other|tDCS|transcranial direct current stimulation (tDCS) stimulation during 20 minutes in the motor cortex (bilaterally) at 1mA of intensity.
15985141|NCT02999516|Other|tDCS sham|tDCS stimulation during 30 seconds in the motor cortex (bilaterally) at 1mA of intensity and then 19 minutes and 30 seconds without any stimulation.
15985142|NCT02999516|Other|Neurofeedback|EEG monitoring of the cerebral cortex in real time with positive feedback in the computer screen when participants motor cortex is activated. The positive feedback consist in an object that moves to the top of the screen when activation occurs in the motor cortex. This task last during 20 minutes.
15985143|NCT02999516|Other|Neurofeedback sham|EEG monitoring of the cerebral cortex in real time with randomized feedback in the computer screen despite motor cortex activation. The positive feedback consist in an object that moves to the top of the screen in a randomized time. This task last during 20 minutes.
15985144|NCT02999503|Behavioral|Nutritional education|Nutritional education trough a personal online nutritional consultant
15985145|NCT02999490|Radiation|18F-FDG|18F-FDG is positron emission tomography imaging agent which is already widely used in PET/CT examination.
15985146|NCT02999477|Drug|Pembrolizumab|Pembrolizumab will be administered in clinic every three weeks.
15985147|NCT02999477|Drug|Nab-Paclitaxel|Nab-Paclitaxel will be administered in clinic every week.
15985148|NCT02999477|Procedure|Biopsy|Biopsies for research purposes will be performed at three separate timepoints during treatment.
15985149|NCT02999464|Other|Qigong|The experimental group will be required to practice a total of 50 minutes of qigong training 3 times per week and for 16 weeks
15985150|NCT02999464|Other|Fitness exercise|Active control group will be required to practice a total of 50 minutes of fitness training 3 times per week and for 16 weeks
15985151|NCT02999451|Device|snare-assisted POEM|"POEM is performed by using a snare which is retracted into the sheath to expose the tip, leaving a 1-2mm length for operation.
~After submucosal injection, an initial 2-cm mucosal incision is made by a snare in the posterior esophageal wall.
~A submucosal tunnel from the esophagus to the gastric cardia is created using a snare.
~Full-thickness myotomy is performed and extended 2-3 cm beyond the esophagogastric junction (EGJ) using a snare.
~The mucosal incision is closed with endoclips."
15985152|NCT02999451|Device|knife-assisted POEM|"POEM is performed by using a conventional endoscopic knife.
~After submucosal injection, an initial 2-cm mucosal incision is made by a knife in the posterior esophageal wall.
~A submucosal tunnel from the esophagus to the gastric cardia is created using a knife.
~Full-thickness myotomy is performed and extended 2-3 cm beyond the esophagogastric junction (EGJ) using a knife.
~The mucosal incision is closed with endoclips."
15985153|NCT02999438|Device|Actigraph to check activity levels at home|
15985154|NCT02999425|Other|Education|Educational intervention
15985155|NCT02999412|Procedure|Comprehensive medication review|"A thorough medication reconciliation, including a patient/carer interview, by a clinical pharmacist.
~The clinical pharmacist performs a comprehensive medication review in collaboration with the ward physician and patient, similar to a level three clinical medication review as earlier described in the literature [4]. This includes a structured, critical examination of all of the patient's medications in relation to the patient's conditions, based on information from the patient and the medical record. The objective is to optimise the impact of medications and minimizing the number of medication-related problems. The effects of medication changes will be monitored during the hospital stay by the physician or pharmacist, depending on the specific situation.
~Before discharge, the clinical pharmacist performs another medication reconciliation to check if the patient's prescriptions for medications to be used after hospital stay are consistent with the patient's medical record."
15985223|NCT02998918|Dietary Supplement|PolyResveratrol Supplementation|Participants will take 1 mg of a polyresveratrol phytosome supplement each day for one week. The acute effect (1 hr) of one 500 mg dose of the polyresveratrol phytosome supplement on inflammation will be examined along with the short-term effect (1 week).
15985270|NCT02998554|Drug|SHP640|Instill 1 drop of SHP640 (PVP-I 0.6% and Dexamethasone 0.1%) ophthalmic suspension in each eye 4 times daily (QID) (with a minimum of 2 hours between doses) for 7 days.
15985156|NCT02999412|Procedure|Comprehensive medication review with active follow-up|"The same as I1 but with the following additions:
~In case of any monitoring needs or necessary subsequent actions to be taken after hospital discharge, the clinical pharmacist and the ward physician send an electronic medication review referral to the patient's primary care physician upon discharge.
~A first phone call to the patient or carer is made by the clinical pharmacist 2-7 days after the patient is discharged depending on health condition and the pharmacist's availability. This phone call aims to ensure that all information has been understood correctly and to find out if any problems, concerns or questions have arisen after discharge.
~A second phone call will be made by the clinical pharmacist approximately 30 days after hospital discharge. This phone call aims to find out how the patient is managing the medication and if any problems, concerns or questions have arisen, and to provide the patient with a motivational boost."
15985157|NCT02999412|Procedure|Usual Care|The control group will receive usual hospital care. According to Swedish legislation, usual care includes medication reconciliation upon admission. Next to that, the law requires a medication report addressing the patient's medication treatment to be given to the patient or carer upon hospital discharge and to be attached to the electronic discharge letter. This report contains a motivation and explanation to the changes in medication treatment that have been made during hospital stay, as well as the patient's updated medication list. These mandatory activities are currently carried out to various degree within the different hospitals and wards. Other activities as described in the interventions above may be carried out to a certain degree as well, but no clinical pharmacist will be involved.
15985158|NCT02999399|Other|Brussel Sprouts|Subjects are given ~150 g of Brussels sprouts once daily for 7 consecutive days.
15985159|NCT02999399|Drug|Deuterated Phenanthrene|Subjects are given 1 microgram of deuterated phenanthrene [D10]phe at baseline and after 7 days of Brussels sprout consumption. Urine is collected for 6 hours after each dose.
15985160|NCT02999373|Other|Autologous Umbilical Cord Blood Mononuclear Cells Therapy|Autologous Umbilical Cord Blood Mononuclear Cells Therapy in preterm for prevention of infection
15985161|NCT02999373|Drug|0.9% Sodium Chloride|0.9% Sodium Chloride in control group
15985162|NCT02999360|Behavioral|Language therapy|There will be three blocks of treatment, ideally three times a week 100 minutes per day. Treatment will target impairment-directed speech language therapy (SLT) approaches or compensatory-directed SLT in each of the three treatment blocks. Half of the participants will receive the impairment-directed SLT. Half of the participants, will receive treatment that will target compensatory-directed speech language therapy approaches that are focused on functional communication skills in the conversational context. Methods of treatment will include PACE (Promoting Aphasics Communicative Effectiveness (Davis, 2005), conversational coaching (Hopper et al., 2002), and supported conversation (Kagan et al., 2001). The clinician will model and encourage all (verbal and non verbal) modalities of communication.
15985163|NCT02999360|Behavioral|Background Music|30 minutes background music only
15985164|NCT02999360|Behavioral|Aerobic Exercise|There will be three blocks of treatment and the AE will take place for all participants during one or two treatment blocks (randomly assigned), threetimes a week (sessions are three times a week prior to speech therapy but may be one or two times a week if a session is missed or may be up to four or five times a week if one or two sessions are missed and rescheduled due to weather or other circumstances).
15985165|NCT02999334|Behavioral|Group Antenatal Care|To examine the effect of type of care on completion of the recommended antenatal and postnatal visits as well as perinatal health outcomes, including knowledge, behaviors, psychosocial well-being, pregnancy-related empowerment, satisfaction with ANC care.
15985166|NCT02999321|Other|aspartame|will be given 5mg aspartame or 15 mg aspartame
15985167|NCT02999321|Other|water|control group
15985168|NCT02999308|Other|Observe the patient's condition and then change the regimen|The patients will be assessed every 3 months and the treatment regimen will be modified by the result of assessment.
15985169|NCT02999295|Biological|Ramucirumab|Ramucirumab (8 mg/kg) is administered.
15985170|NCT02999295|Biological|Nivolumab|Nivolumab (3.0 mg/kg or 1.0 mg/kg) is administered.
15985171|NCT02999282|Device|Anodal transcranial direct current stimulation|10 sessions of anodal transcranial direct current stimulation (5 days/week for 2 weeks)
15985172|NCT02999282|Device|Sham transcranial direct current stimulation|10 sessions of sham transcranial direct current stimulation (5 days/week for 2 weeks)
15985173|NCT02999269|Device|MECTA Spectrum 5000Q Amplitude|Current
15985174|NCT02999256|Dietary Supplement|Montmorency Tart Cherry Juice|
15985175|NCT02999256|Other|Placebo|
15985176|NCT02999243|Behavioral|HIV self-testing|The intervention group will be offered HIV self-testing kits for testing HIV status
15985177|NCT02999243|Behavioral|Harm reduction education|Both arms will receive harm reduction education
15985178|NCT02999230|Other|Caries Free 1.5% Arginine|Study toothpaste assigned containing 1.5% Arginine. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day.
15985179|NCT02999230|Other|Caries Free Placebo Sodium Fluoride|Marketed Toothpaste containing 1100 ppm F as Sodium Fluoride will be assigned. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day.
15985180|NCT02999230|Other|Caries Active 1.5% Arginine|Study toothpaste assigned containing 1.5% Arginine. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day.
15985181|NCT02999230|Other|Caries Active- Placebo Sodium Fluoride|Marketed Toothpaste containing 1100 ppm F as Sodium Fluoride will be assigned. Subjects will also receive a Colgate Wave Comfort Adult Toothbrush to brush their teeth with twice a day.
15985182|NCT02999217|Drug|Iron isomaltoside|"Intravenous injection 1 g given postoperatively in the recovery ward.
~Blood tests including red blood cell count, plasma ferritin, haemoglobin, haematocrit, mean corpuscular volume, mean haemoglobin concentration are made 1 day preoperatively, day 1, day 3 postoperatively, day of discharge and 1 month after discharge.
~Reticulocyte count and reticulocyte haemoglobin concentration tests are made on the day of discharge and 1 month after discharge.
~Count of total consumption of intravenous blood products. Count of total intravenous fluids. Clinical recovery and complications. Duration of hospital stay."
15985224|NCT02998918|Dietary Supplement|Curcumin Supplementation|Participants will take 1 mg of a curcumin phytosome supplement each day for one week. The acute effect (1 hr) of one 500 mg dose of the curcumin phytosome supplement on inflammation will be examined along with the short-term effect (1 week).
15985183|NCT02999217|Drug|Saline|"Intravenous injection given postoperatively in the recovery ward.
~Blood tests including red blood cell count, plasma ferritin, haemoglobin, haematocrit, mean corpuscular volume, mean haemoglobin concentration are made 1 day preoperatively, day 1, day 3 postoperatively, day of discharge and 1 month after discharge.
~Reticulocyte count and reticulocyte haemoglobin concentration tests are made on the day of discharge and 1 month after discharge.
~Count of total consumption of intravenous blood products. Count of total intravenous fluids. Clinical recovery and complications. Duration of hospital stay."
15985184|NCT02999204|Drug|Vitamin D3|Two different doses of Vitamin D3
15985185|NCT02999191|Drug|BI 1467335 (Treatment A)|
15985186|NCT02999191|Drug|BI 1467335 (Treatment B)|
15985187|NCT02999191|Drug|BI 1467335 (Treatment C)|
15985188|NCT02999178|Drug|Nintedanib|
15985189|NCT02999178|Drug|Placebo|
15985190|NCT02999165|Other|Breast feeding|Infants on respiratory support will be allowed to attempt to breast feed (with a top up nasogastric tube feed if required).
15985191|NCT02999165|Other|Nasogastric feeding|The control intervention is feeding via nasogastric tube
15985192|NCT02999152|Other|blood and urines samples|"For all patients the blood samples must be organized: Before, 4 hours (+/-30 min), 1 day, 2 days, and 3 days after the start of the radiation therapy.
~Collections of urine must be organized: Before, 1 day, and 2 days after the radiation therapy."
15985193|NCT02999126|Drug|Propofol|Propofol intravenously by a stepwise TCI titration with Marsh pharmacokinetic model
15985194|NCT02999126|Drug|Remifentanil Hydrochloride|Remifentanil intravenously 6 ng/ml by TCI effect site, 3 min prior to intubation and maintained at that concentration throughout the study. If clinical signs of inadequate analgesia are present, remifentanil target concentration will be increased by 1 ng/ml.
15985195|NCT02999100|Drug|IH Oxytocin|Oxytocin will be supplied as colourless and clear hard capsule with powder blend for inhalation with unit dose strength 400 mcg and 200 mcg. It will be administered using ROTAHALER dry powder inhaler (DPI).
15985196|NCT02999100|Drug|IM Oxytocin|Oxytocin will be supplied for solution for infusion in 1ml ampoule containing colourless and clear sterile solution with unit dose strength 5 I.U./mL, or 10 I.U./mL for IM administration
15985197|NCT02999100|Drug|IV Oxytocin|Oxytocin will be supplied as solution for infusion in 1ml ampoule containing colourless and clear sterile solution to be administered as a 30-second IV bolus with unit dose strength 5 I.U./mL, or 10 I.U./mL.
15985198|NCT02999100|Device|ROTAHALER|ROTAHALER DPI device is a high airflow resistance capsule-based inhaler. It will be used to deliver IH oxytocin
15985199|NCT02999087|Drug|Cetuximab|Loading dose of 400 mg/m² IV on Day-8, followed by weekly dose of 250 mg/m² IV during the whole course of RT.
15985200|NCT02999087|Drug|avelumab|IV infusion of avelumab (10 mg/kg over 1 hour) once every 2 weeks. Avelumab will start on Day-8 together with cetuximab and subsequently every 2 weeks during the course of RT. Avelumab with be continued every 2 weeks for an additional 12 months following RT.
15985201|NCT02999087|Drug|Cisplatin|100 mg/m² IV after hyperhydration and at a maximal rate of 1 mg/min, on days 1, 22, 43.
15985202|NCT02999087|Radiation|IMRT|RT will be performed using IMRT (intensity modulated radiotherapy), with a simultaneous integrated boost (SIB) technique. RT dose to the GTV will be 69.96 Gy in 2.12 Gy daily fractions over 6.5 weeks (33 fractions). Prophylactic dose will be 52.8 Gy in 1.6 Gy daily fractions over 6.5 weeks (33 fractions).
15985203|NCT02999074|Other|Resistance exercise|The training will take place twice weekly over the course of neoadjuvant CTx at the NCT Heidelberg or in regional qualified centers under supervision and guidance of experienced exercise therapists. The progressive resistance exercise comprises 8 machine-based exercises, each performed in 3 sets, 12 repetitions at 60-80% of one repetition maximum (1-RM).
15985204|NCT02999074|Other|Aerobic exercise|The training will take place twice weekly over the course of neoadjuvant CTx at the NCT Heidelberg or in regional qualified centers under supervision and guidance of experienced exercise therapists. The aerobic exercise will be performed on a cycle ergometer (or alternatively at a treadmill, elliptical, rowing ergometer, or combination) progressing from 60% to 70% VO2max with increasing duration. During weeks 7-18 the goal is to perform an extensive interval training.
15985205|NCT02999074|Other|Usual care during neoadjuvant chemotherapy/Exercise after surgery|The control group receives no exercise intervention during neoadjuvant CTx, which reflects the usual care condition. To investigate effects of different exercise timing, and to provide those patients also a potential health benefit and reduce drop-out and contamination, the control group will receive 18 weeks resistance or aerobic exercise (according to their personal preferences) after breast cancer surgery.
15985206|NCT02999048|Drug|Panax Notoginseng Saponins|Panax Notoginseng Saponins integrated with conventional therapy
15985207|NCT02999022|Drug|Lithium Carbonate|Intervention begins 14 days after injury for non-surgical participants and 2 weeks after surgery for participants who have surgical treatment of their fractures.
15985208|NCT02999022|Drug|Lactose Placebo|Intervention begins 14 days after injury for non-surgical participants and 2 weeks after surgery for participants who have surgical treatment of their fractures.
15985209|NCT02999009|Device|Trident II Tritanium Acetabular Shell|A hemispherical acetabular shell indicated for cementless application.
15985210|NCT02998996|Biological|15 µg HA/strain and 1% Endocine™|intranasal administration
15985211|NCT02998996|Biological|15 µg HA/strain and 2% Endocine™|intranasal administration
15985212|NCT02998996|Biological|15 µg HA/strain|intranasal administration
15985213|NCT02998996|Biological|intramuscular comparator|intramuscular administration
15985214|NCT02998996|Biological|intranasal comparator|intranasal administration
15985215|NCT02998996|Biological|Placebo, Saline|intranasal administration
15985216|NCT02998983|Drug|Racotumomab|
15985217|NCT02998970|Drug|Empagliflozin|single oral tablet once daily.
15985218|NCT02998970|Drug|Placebo|single oral tablet once daily.
15985219|NCT02998957|Device|AcuTENS|Stimulation of acupuncture point Dingchuan using transcutaneous electrical nerve stimulation (TENS) instead of needles
15985220|NCT02998957|Device|Sham AcuTENS|Portable TENS electrostimulation device with no electrical output
15985221|NCT02998931|Drug|Glutamin|Enteral Glutamine 0.3g/kg/day powdered glutamine to be mixed in with water and given via nasogastric tube q4 hrs
15985222|NCT02998931|Other|Maltodextrin|Maltodextrin mixed with water given via NG tube Q 4 hours
15985225|NCT02998905|Drug|NOAC|Apixaban or dabigatran or edoxaban or rivaroxaban at recommended dosing for stroke prevention in atrial fibrillation. The particular agent is at the discretion of the local investigator.
15985226|NCT02998905|Drug|Acetylsalicylic Acid|Acetylsalicylic acid 81 mg/day
15985227|NCT02998892|Behavioral|Traditional Exercise Training|Participants will be asked to perform moderate-intensity exercise (brisk walking) for 45 minutes for 5 days/week for 4 weeks. This intervention corresponds to the current recommendations.
15985228|NCT02998892|Behavioral|Daily Microbursts of Activity|Participants will be asked to break up their sedentary activities of daily living for 5-minutes every hour for 10 hours, 5 days/week, by brisk walking for 4 weeks.
15985230|NCT02998866|Procedure|Esophageal Temperature-Guided Ablation|Esophageal temperature-guided ablation (if esophageal temperatures drop too low during cryoablation, the physician will stop the ablation) in order to increase the safety profile of cryoballoon pulmonary vein (a vein carrying blood from the participants lungs to the left side of the participants heart known as the left atrium) isolation (PVI [means a balloon shaped catheter will be placed at the opening of each pulmonary vein and tissue will be cooled in order to create an ablation line (line of scar tissue) between the left side of the participants heart and each pulmonary vein. This is done to prevent the triggers that typically cause intermittent atrial fibrillation (known as Paroxsymal Atrial Fibrillation) by providing one center's experience.
15985231|NCT02998853|Other|QFR measurement by dedicated workstation on xrays angio selected runs|The patient undergoes coronary angiography; if at least one stenosis from 40 to 90% in non culprit is present and FFR is indicated by guidelines the patient is enrolled to 3d Angio QFR evaluation; no adjunctive invasive procedures are needed for QFR measurements
15985232|NCT02998840|Biological|B244|odorless suspension
15985233|NCT02998840|Biological|Vehicle|odorless suspension
15985234|NCT02998827|Drug|Thalidomide|
15985235|NCT02998827|Drug|infliximab, azathioprine|other treatment include infliximab, azathioprine
15985236|NCT02998827|Other|enteral nutrition|
15985237|NCT02998814|Other|acid-etch|acid-etch
15985238|NCT02998814|Other|self-etch adhesive|Self etch (7th generation ) bonding agent
15985239|NCT02998814|Other|etch-and-rinse adhesive|Total etch bonding agent (5th generation)
15985240|NCT02998814|Other|self-etch adhesive after acid-etch|acid etch + self-etch adhesive Self etch (7th generation ) bonding agent
15985241|NCT02998801|Other|IPAD|Patients undergoing surgery will watch the video using an PAD
15985242|NCT02998801|Other|VR Goggles|Patients undergoing surgery will watch the video using goggles
15985243|NCT02998775|Drug|Plasma Sampling|No lenvatinib will be administered in this study; however, plasma samples will be obtained for assessment of in vitro lenvatinib protein binding.
15985244|NCT02998736|Drug|Cialis|"Cialis 20 mg daily by mouth for 16 day. 5 days prior to surgery, day of surgery and 10 days post surgery.
~Influenza vaccine 0.5mL day of surgery"
15985245|NCT02998736|Biological|Influenza vaccine|One 0.5mL intramuscular injection the day of surgery
15985246|NCT02998723|Other|Early Booster Teaching|The early booster group will receive a booster teaching session at 3 weeks post-training followed by feedback.
15985247|NCT02998723|Other|Late Booster Teaching|The late booster group will receive a booster teaching session at 2 months post-training followed by feedback
15985248|NCT02998697|Drug|Ferrous Sulfate|Ferrous sulfate 200 mg t.i.d for 90 days
15985249|NCT02998697|Drug|Placebo Oral Capsule|Lactose 200 mg t.i.d for 90 days
15985250|NCT02998684|Device|Active Transcranial Direct Current Stimulation|
15985251|NCT02998684|Device|Sham Transcranial Direct Current Stimulation|
15985252|NCT02998684|Behavioral|PEERS Social Skills Training|14 weekly social skills training sessions for all participants
15985253|NCT02998671|Biological|CJM112|
15985254|NCT02998671|Other|Placebo|
15985255|NCT02998658|Device|Vaginal cuff closure using barbed sutures|Vaginal cuff will be closed using a 24-cm × 24-cm 0 polydioxanone double-armed suture on a 26-mm half-circle reverse cutting needle( STRATAFIX™ Spiral PDO Knotless Tissue Control Device, Ethicon Inc , Somerville, NJ, USA )
15985256|NCT02998658|Device|Vaginal cuff closure using conventional sutures|Vaginal cuff will be closed using 1-0 polyglactin 910 suture(VICRYL™.; Ethicon Inc, Sommerville, NJ) .
15985259|NCT02998632|Procedure|Mineralized plasmatic matrix for bone augmentation|Vertical bone augmentation of defective posterior mandibular alveolar ridge using MPM (Mineralized Plasmatic Matrix) bone graft.
15985260|NCT02998632|Procedure|Autogenous bone for bone augmentation|Vertical bone augmentation of defective posterior mandibular alveolar ridge using autogenous bone graft (gold standard) covered by titanium membrane.
15985261|NCT02998619|Radiation|Radiotherapy|Radiation to prostate/seminal vesicles including pelvic lymph nodes Postoperative radiation to prostate bed including pelvic lymph nodes
15985262|NCT02998606|Drug|Naloxegol|MOVANTIK™ 25 mg, daily
15985263|NCT02998606|Drug|Placebo Oral Capsule|Placebo 25 mg, daily
15985264|NCT02998593|Drug|Bahman capsules|Oral Use of Bahman capsules for 3 months by patients.
15985265|NCT02998593|Drug|Placebo|Oral use of placebo capsules by patients for 3 months.
15985266|NCT02998580|Device|LFR followed by HFL|Magventure Cool B70 Coil with RX100 Stimulator
15985267|NCT02998580|Device|cTBS followed by iTBS|Magventure Cool B70 Coil with RX100 Stimulator
15985268|NCT02998567|Drug|Guadecitabine|In arm 1 (escalation) and 2 (expansion).
15985269|NCT02998567|Drug|Pembrolizumab|In arm 1 (escalation) and 2 (expansion).
15985271|NCT02998554|Drug|Placebo|Instill 1 drop of placebo ophthalmic solution in each eye QID for 7 days.
15985272|NCT02998541|Drug|SHP640|Participants will receive one drop of SHP640 (0.1 % dexamethasone and 0.6% PVP-I) ophthalmic suspension in each eye QID (with a minimum of 2 hours between doses) for 7 days.
15985273|NCT02998541|Drug|PVP-I 0.6%|Participants will receive one drop of PVP-I ophthalmic solution in each eye QID (with a minimum of 2 hours between doses) for 7 days.
15985274|NCT02998541|Other|Placebo|Participants will receive one drop of placebo ophthalmic solution in each eye QID (with a minimum of 2 hours between doses) for 7 days.
15985275|NCT02998528|Biological|Nivolumab|
15985276|NCT02998528|Drug|Cisplatin|
15985277|NCT02998528|Drug|Vinorelbine|
15985278|NCT02998528|Drug|Gemcitabine|
15985279|NCT02998528|Drug|Docetaxel|
15985280|NCT02998528|Drug|Pemetrexed|
15985281|NCT02998528|Drug|Carboplatin|
15985282|NCT02998528|Drug|Paclitaxel|
15985283|NCT02998528|Biological|Ipilimumab|This arm is closed and no longer enrolling patients.
15985284|NCT02998515|Device|Companion (Liquid oxygen device)|
15985285|NCT02998515|Device|Activox (concentrator)|
15985286|NCT02998502|Device|Freespira Breathing System|Over an 8-week period the efficacy of the FBS system in youth will be tested, with those in the randomized active device group. The control group will not receive the device until completion of the 8 week baseline.
15985287|NCT02998489|Other|Fast milk advancement|30-40 cc/kg/d of human milk or formula milk until total enteral feeding has been achieved
15985288|NCT02998489|Other|Traditional milk advancement|20 cc/kg/d of human milk or formula milk until total enteral feeding has been achieved
15985289|NCT02998476|Drug|Parsaclisib|Parsaclisib once daily for 8 weeks followed by once weekly
15985290|NCT02998463|Device|skin-to-skin facilitating garment|Fabric garment designed to accommodate term neonates having skin-to-skin contact.
15985291|NCT02998450|Drug|IMR-687|1 of 6 possible single doses administered orally following overnight fast
15985292|NCT02998450|Drug|Placebo Oral Capsule|Placebo oral capsule with 50 mg microcrystalline cellulose in capsules identical to those used for the active pharmaceutical ingredient.
15985293|NCT02998437|Drug|Ilaprazole 10mg|Period 1: Ilaprazole 10mg, one a day, one day Period 2: Ilaprazole 10mg, twice a day, 6 days
15985294|NCT02998437|Drug|Clarithromycin 500mg|Period 1: Clarithromycin 500mg 1 tab., twice a day, one day Period 2: Clarithromycin 500mg 1 tab., one a day at 5 day
15985295|NCT02998437|Drug|Amoxicillin 500 Mg|Period 1: Amoxicillin 500mg 2 cap., one a day, one day Period 2: Amoxicillin 500mg 2 cap., one a day at 5 day
15985296|NCT02998424|Drug|Propofol|Continuous infusion
15985297|NCT02998424|Device|Pupillary diameter measurement|Instantaneous measure
15985298|NCT02998411|Other|Titration|
15985299|NCT02998398|Other|Switch from REMICADE® to INFLECTRA®|Treatment with an infliximab biosimilar (i.e. INFLECTRA® ) for all patients which have been treated by REMICADE® for at least 4 months
15985300|NCT02998385|Drug|Cisplatin|intravenous, concomitant to irradiation
15985301|NCT02998385|Radiation|radiotherapy|66 à 70 Gy per fractions of 2 Gy, 1 fraction/day, 5 fractions/week
15985302|NCT02998372|Procedure|patellar stabilization|surgery to either alter soft tissues around the patella or reorient the patellar tendon to restore patellar stability
15985303|NCT02998359|Device|Hemiarthroplasty|A cemented polished double taper stem hemiarthroplasty inserted via an anterior-lateral surgical approach (Zimmer incorporated, UK).
15985304|NCT02998359|Device|Total hip arthroplasty|A cemented polished double taper stem arthroplasty stem inserted via an anterior-lateral surgical approach with a cemented acetabular cup (Zimmer incorporated, UK).
15985305|NCT02998333|Procedure|Surgical stabilization|Surgical stabilization of the ankle joint, performed as an open or arthroscopic procedure.
15985306|NCT02998320|Drug|Genvoya|Oral use (one tablet each day); 150/150/200/10 mg; 28 days
15985307|NCT02998307|Procedure|CPR Training|Brief CPR assessment and training done during working hours with real-time performance feedback
15985308|NCT02998294|Device|Respiratory Volume Monitor(RVM)|The purpose of this study was to determine the accuracy of one-time respiratory volume measured by RVM compared to the one-time respiratory volume measured by mechanical ventilation in post-operative ICU patients.
15985309|NCT02998294|Device|artificial respirator|The purpose of this study was to determine the accuracy of one-time respiratory volume measured by RVM compared to the one-time respiratory volume measured by mechanical ventilation in post-operative ICU patients.
15985310|NCT02998281|Device|Threshold (IMT)|Training is going to perform by using a pressure threshold- loading device (Threshold, IMT, USA) used to inhale against a same-pressure load every inhalation for strengthening primarily the diaphragm and rib cage muscles. The device pressure is adjusted according to PImax, and reliability/reproducibility has been demonstrated.
15985311|NCT02998268|Drug|Pembrolizumab|Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
15985312|NCT02998268|Drug|Taxol|Taxol is a novel antimicrotubule agent that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions.
15985313|NCT02998268|Drug|Carboplatin|Carboplatin is a platinum coordination compound that is used as a cancer chemotherapeutic agent. Carboplatin produces predominantly interstrand DNA cross-links rather than DNA -protein cross-links.
15985314|NCT02998255|Drug|Single dose of 2L PEG|Patients at average risk for inadequate BP were given instructions for bowel preparation through phone call a day before scheduled colonoscopy. Patients began to drink 2 L of PEG 4-6 hours before colonoscopy at a rate of 250 mL every 15 minutes.
15985315|NCT02998255|Drug|Split dose of 4L PEG|All patients at average risk for inadequate BP were given instructions for bowel preparation through phone call a day before scheduled colonoscopy. the participants began to drink the first 2 L of PEG at 7:00-9:00 PM on the day before colonoscopy at a rate of 250 mL every 15 minutes. On the day of the procedure, patients took the remaining 2 L 4-6 hours before colonoscopy.
15985316|NCT02998242|Drug|Apatinib|
15985317|NCT02998242|Radiation|SBRT to symptomatic bony metastatic bony site(s)|
15985318|NCT02998229|Device|Artisse™|Intrasaccular Device
15985319|NCT02998216|Procedure|Bilateral sacrospinous fixation|Bilateral sacrospinous vaginal suspension
15985320|NCT02998203|Dietary Supplement|Organic diet|Full organic diet from certified organic products as obtained from certified producers and cooked by a certified organic restaurant. five meals each day delivered to students.
15985321|NCT02998190|Drug|Single Ascending Doses of EB8018|
15985322|NCT02998190|Drug|Single Ascending Doses of placebo|
15985323|NCT02998190|Drug|Multiple Ascending Doses of EB8018|
15985324|NCT02998190|Drug|Multiple Ascending Doses of placebo|
15985325|NCT02998164|Behavioral|augmentative and alternative communication technology|
15985326|NCT02998164|Behavioral|Usual Care|No change to the therapy care received
15985327|NCT02998151|Drug|Acamprosate|two 666 pills
15985328|NCT02998151|Drug|Lovastatin|two 20mg pills
15985329|NCT02998151|Drug|Minocycline|two 135mg pills
15985330|NCT02998151|Drug|Placebo|
15985331|NCT02998125|Procedure|Total knee arthroplasty|prospective assessments for the functional outcome before and after the total knee arthroplasty
15985332|NCT02998112|Drug|fecal microbiota transplantation|Fecal microbiota which was purified from fresh stool defecated by a healthy donor
15985333|NCT02998112|Drug|Saline|
15985334|NCT02998099|Drug|Rivipansel|A single dose of IV rivipansel over 20 minutes.
15985335|NCT02998086|Behavioral|Promoting Resilience in Stress Management|Skills-based intervention designed to promote resilience resources
15985336|NCT02998073|Behavioral|Stop, Now and Plan|SNAP program was developed to target justice-involved youth (6 years and older) who have problems with aggression, CD, and/or gang affiliation. SNAP focuses on engaging youth in interesting and creative learning modules by providing real life scenarios designed to improve self-control, impulsive behaviors, decision-making skills, and pro-social skills. SNAP treatment is delivered over a 13-week period.
15985337|NCT02998060|Procedure|Pedicle Screw Placement|As a part of the lumbar spinal fusion procedure, posterior pedicle screws will be placed.
15985338|NCT02998060|Device|SpineAssist®/Renaissance® (Mazor Robotics Ltd. Caesarea, Israel)|This robot will be used to guide pedicle screws into their trajectories.
15985339|NCT02998060|Device|3D C-Arm (Ziehm Imaging, Nuremberg, Germany)|This 3D Fluoroscope will be used to navigate pedicle screws into their trajectories.
15985340|NCT02998047|Drug|Lintuzumab AC 225|Lintuzumab-Ac225 is an immunoconjugate [antibody: anti-CD 33 antibody and radioactive isotope: Actinium (225Ac)] for the treatment of multiple myeloma.
15985341|NCT02998034|Device|Uncemented Furlong Hemiarthroplasty|A furlong uncemeneted hyroxyapatite coated prosthesis.The hydroxyapatite stimulates bone ingrowth around the prosthesis and is this is thought to reduce loosening of the implant, residual pain and the long-term revision rate.
15985342|NCT02998034|Device|Cemented tapered stem hemiarthroplasty|A cemented double tapered stem hemiarthroplasty
15985343|NCT02998021|Device|Vibrating Dumbbell|Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks. The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively, first by increasing the frequency of the vibration (max. 40 Hz) then by the addition of more weight, based on weekly assessments and consultation with the senior investigators.
15985344|NCT02998021|Device|Standard Dumbbell|"Supervised training sessions will occur optimally, 3 times per week for a total of 12 consecutive weeks.
~The sessions will involve nine exercises specifically designed to improve upper limb muscle function. The beginning training intensity for each participant will be based on their one rep max for each exercise, which is determined during baseline laboratory testing in accordance with standard procedures. Training intensity will be adjusted progressively by the addition of more weight, based on weekly assessments and consultation with the senior investigators.
~To obtain as much data as possible on resistance training with vibration within study timeline, a modification was recently approved by the Institutional Review Board (IRB) to cease enrolling subjects into standard dumbbell training."
15985345|NCT02998008|Behavioral|high intensity interval training|
15985346|NCT02997995|Drug|Immune-attractant|The first cohort patients will receive tremelimumab (3 mg/kg, single infusion) as immune-attractants combined with exemestane (25 mg daily).
15985347|NCT02997995|Drug|Durvalumab|Durvalumab (lymphocyte activation) will be administrated at a dose of 1500 mg Q4W (equivalent to 20 mg/kg Q4W) IV, combined with exemestane (25 mg daily), for six months
15985348|NCT02997995|Procedure|Biopsy|After three weeks (+/- 3 days) of immune-attractants, a tumor biopsy will be done. Patients who present >10% CD8+ cells in the tumor after 3 weeks will receive the Durvalumab
15985349|NCT02997982|Drug|Valaciclovir 500Mg Tablet|Valaciclovir treatment (oral, 500 mg tablets). First week: 500 mg three times daily, second to fourth week: 1000 mg three times daily.
15985350|NCT02997969|Biological|DNA-HIV-PT123 vaccine|Contains a mixture of 3 DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C ZM96 gag, 2) clade C ZM96 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose 4 mg administered as 1 mL intramuscularly (IM)
15985351|NCT02997969|Biological|Protein/MF59 vaccine|clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered as 0.5 mL IM
15985352|NCT02997969|Biological|Placebo|Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products
15985353|NCT02997956|Drug|Tocilizumab|Participants will receive Tocilizumab (ACTEMRA®) at 4, 6, or 8 mg/kg IV dose escalation on days 1, 29 and 57.
15985354|NCT02997956|Procedure|Transcatheter Arterial Chemoembolization|Minimally invasive procedure performed in interventional radiology to restrict a tumor's blood supply
15985355|NCT02997943|Behavioral|Step 1 Treatment: APP|Participants will receive a smartphone app to track weight, dietary intake and physical activity, and a technology core consisting of web-based weekly lessons, wireless scale, and activity tracker. Participants will use their own smartphone to receive the study smartphone application.
15985356|NCT02997943|Behavioral|Step 1 Treatment: APP + Coaching|Participants will receive a smartphone app to track weight, dietary intake and physical activity; a technology core consisting of web-based weekly lessons, wireless scale, and activity tracker; 12 weekly telephone coaching sessions. Participants will use their own smartphone to receive the study smartphone application.
15985357|NCT02997943|Behavioral|Step 2 Treatment Strategy: Modest Step-up|In addition to first line treatment, participants identified as non-responders will be provided an additional mHealth intervention component (push notifications) for the remaining 12 weeks.
15985358|NCT02997943|Behavioral|Step 2 Treatment Strategy: Vigorous Step-up|In addition to the first line treatment, participants identified as non-responders will be provided an additional mHealth intervention component (push notifications) plus a traditional weight loss intervention component (coaching, meal replacements).
15985359|NCT02997930|Behavioral|fMRI|fMRI for measuring function connectivity and DTI will be done between day 2 to day 5.
15985360|NCT02997930|Behavioral|Montreal Cognitive Assessment (MoCA)|A measure of general cognition
15985361|NCT02997930|Behavioral|Digital Clock Drawing Test Command and Copy|A measure of current cognition using digital pen technology
15985362|NCT02997930|Behavioral|Wide Range Achievement Test reading subtest|A measure of premorbid intellectual estimate
15985363|NCT02997930|Behavioral|Hopkins Verbal Learning Test (HVLT)|A measure of declarative memory
15985364|NCT02997930|Behavioral|General Depression Scale (GDS)|A measure of the of presence of depression.
15985365|NCT02997917|Behavioral|Education|
15985366|NCT02997917|Behavioral|Sham|
15985367|NCT02997904|Device|Apply Liquid Then Comb Out|Apply liquid to dry hair, wait for 5 minutes, then comb out lice and eggs for up to one hour
15985368|NCT02997891|Diagnostic Test|everyday activity|To objectively quantify the everyday activity, there are a variety of instruments, without a currently gold standard. Therefore, in addition the investigators use objectified measurement parameters with the aid of a pedometer (GARMIN vivofit) on every three measuring time points (before surgery, 3 months after surgery, 6 months after surgery).
15985369|NCT02997891|Diagnostic Test|cognitive performance|Standardized neuropsychological assessment methods are used to assess the cognitive performance. To assess the degree of mobility, health status and the physical activity standardized questionnaires are used.
15985370|NCT02997878|Biological|Orbcel-C|Selected Mesenchymal Stromal Cells derived from human ubmical cord
15985371|NCT02997865|Behavioral|Stepped care for depression|Cognitive behavior therapy (CBT), plus referral to the participant's own physician to discuss antidepressant medications if indicated.
15985372|NCT02997852|Behavioral|Therapy dog visitation|The TDV will consist of a 10-minute visit from the same Faithful Paws animal handler and her dog. Each therapy dog meets obedience, temperament, and health standards appropriate to therapy dog visitation in hospital settings. The dog will be leashed and under control of the animal handler and the TDV will be casual and not restrict the handler with conversing, which is standard practice in TDV. Visual and tactile contact with the dog will be promoted by the animal handler. Per hospital protocol, the patient will be assisted in washing his/her hands before and after the TDV and the dog will be placed on the bed or remain at the bedside in close proximity allowing petting. A clean sheet will be placed over the patient when the dog is placed on the bed. The research staff will collect data before and after each arm of the study.
15985373|NCT02997839|Behavioral|sleep disruption|"Group two will have interrupted sleep at time periods of 2 hours post operatively.
~Group two will be woken every 2 hours, which is the standard NCCU protocol."
15985374|NCT02997826|Other|Infantil formula|
15985375|NCT02997800|Drug|Esmolol|Following induction and intubation, any increase in heart rate (HR) or mean arterial pressure (MAP) >20% of baseline will be treated with an initial intravenous bolus of esmolol 30 mg IV (30 mg in 5 ml of normal saline). An intravenous esmolol infusion will be initiated at 5mcg/kg/min after the first intravenous bolus dose and will be titrated up by 5mcg/kg/min each time HR or MAP >20% of baseline. An intravenous bolus of placebo (normal saline 1 ml) will be administered whenever a change to the infusion rate is made.
15985376|NCT02997800|Drug|Labetalol|Following induction and intubation, any increase in heart rate (HR) or mean arterial pressure (MAP) >20% of baseline will be treated with an initial intravenous bolus of labetalol 10 mg IV (10 mg in 5 ml of normal saline). Any further increases in HR or MAP >20% of baseline will be treated with intravenous boluses of labetalol 5 mg in 1 ml every 5 minutes as needed. An intravenous placebo infusion (normal saline) will be initiated at 5 mcg/kg/min after the first intravenous bolus dose and will be titrated up by 5 mcg/kg/min each time an additional intravenous bolus is given.
15985377|NCT02997800|Drug|Fentanyl|Following induction and intubation, any increase in heart rate (HR) or mean arterial pressure (MAP) >20% of baseline will be treated with an initial intravenous bolus of fentanyl 50 mcg IV (50 mcg in 5 ml of normal saline). Any further increases in HR or MAP >20% of baseline will be treated with intravenous boluses of fentanyl 25 mcg in 1 ml every 5 minutes as needed. An intravenous placebo infusion (normal saline) will be initiated at 5 mcg/kg/min after the first intravenous bolus dose and will be titrated up by 5 mcg/kg/min each time an additional intravenous bolus is given.
15985378|NCT02997800|Other|saline infusion|An intravenous placebo infusion (normal saline) will be initiated at 5 mcg/kg/min after the first intravenous bolus drug dose (fentanyl or labetalol depending upon randomization) and will be titrated up by 5 mcg/kg/min each time an additional intravenous bolus is given.
15985379|NCT02997800|Other|1 ml saline infusion|Every time the infusion rate of esmolol is changed, 1 ml of normal saline will be infused.
15985380|NCT02997774|Other|Cooler dialysis|Having dialysis at a slightly cooler temperature (35 vs 36.5 degrees Celsius)
15985381|NCT02997774|Other|Standard Dialysis|Having dialysis at a standard temperature (36.5 degrees Celsius)
15985382|NCT02997761|Biological|Blinatumomab|Given IV
15985383|NCT02997761|Drug|Ibrutinib|Given PO
15985384|NCT02997748|Procedure|Remote ischemic preconditioning (RIPC)|3 cycles or more cycles of 5 to 10-min inflation of a blood-pressure cuff to 200 mm HG (or at least to a pressure 50 mmHG higher than the systolic arterial pressure) to one upper arm followed by 5 min reperfusion with the cuff deflated. In Non-Responder two additional cycles of 10 min cuff inflation will be performed in arm 6.
15985420|NCT02997436|Device|Laser speckle flowmetry|"A galvanic current (0.1 mA) will be applied between 2 patches on the forearm of patient and protocol was repeated at 4 minutes.
~Microvascular response to current application (CIV) will be recorded by laser speckle flowmetry 10 minutes later.
~Measurement of the value of skin blood flow (by laser speckle) at the stimulated area as compare to a non stimulated adjacent skin value taken as a reference Usual treatment will be recorded"
15985421|NCT02997410|Device|Ozone|
15985422|NCT02997410|Device|Placebo (for Ozone)|
15985423|NCT02997410|Device|Dental treatment with occlusal splint|
15985385|NCT02997735|Behavioral|Quitline Delivered Treatment|The PA Free quitline is funded by the Pennsylvania Department of Health and staffed by trained cessation counselors available 24 hours a day, 7 days a week. Counseling is available in English and Spanish and can be provided in at least 15 additional languages through a third party. All smokers who enroll in smoking cessation treatment will receive counseling and support consistent with accepted clinical practice guidelines. This treatment includes as many as 5 proactive counseling calls, each designed to help develop problem-solving and coping skills, secure social support, and plan for long-term abstinence. Participants can also call an 800 telephone number as needed for additional support between calls. The timing of counseling calls will be relapse sensitive and include a call 1-2 days after the quit date, another telephone call a week after the first call, and additional calls generally occurring at 2-3-week intervals thereafter.
15985386|NCT02997722|Drug|Ketamine|IV infusion of ketamine 0.5 mg/kg administered over 45 minutes.
15985387|NCT02997722|Drug|Normal Saline|IV infusion of 100 ml of normal saline over 45 minutes.
15985388|NCT02997696|Drug|ONO-4474|
15985389|NCT02997696|Drug|Placebo matching ONO-4474|
15985390|NCT02997683|Device|Body Vibration platform GALILEO|3 month home based training on whole Body Vibration platform GALILEO
15985391|NCT02997683|Other|exercises at home on the floor|exercises at home on the floor
15985392|NCT02997670|Other|Algorithmic Cardiac Resynchronisation Therapy Optimisation|Use of a computer algorithm to run through multiple combinations of pacing options in patients who have a Cardiac resynchronisation pacemaker with defibrillator where a quadripolar lead has been implanted. These quadripolar leads offer extra options for pacing locations across the heart, as well as for different combinations and sequences of pacing stimuli.
15985393|NCT02997657|Behavioral|Positive Psychotherapy|Exercises designed to boost moods, positive behaviors, and positive cognitions.
15985394|NCT02997657|Behavioral|Standard smoking cessation counseling|Counseling designed to provide support and problem solving for smoking cessation
15985395|NCT02997657|Drug|Transdermal Patch, Nicotine|
15985396|NCT02997644|Behavioral|Video Education|"The content of the education focuses on providing a historical perspective for opioid prescription from the time when the risk of dependence was highly underestimated. The video discusses the current evidence for the effect of opioid medications in non-cancer non-acute pain. It also discusses some of the dangers of long-term opioid usage.
~The consent, enrollment, and video education will take about 20-30 minutes for patients in this group, and occur at the end of their preoperative visit. The patient will watch the video on a portable Tablet computer."
15985397|NCT02997644|Behavioral|Usual Care Group|Patients that are randomized to usual care will only receive the regular instructions about opioid usage they typically receive from their surgeon.
15985398|NCT02997631|Device|MEDi Robot|Distraction therapy using an interactive humanoid robot
15985399|NCT02997618|Behavioral|Community based exercise programme|20 week community (home or gym based) exercise programme
15985400|NCT02997618|Other|Control|Usual care consisting of advice.
15985401|NCT02997605|Drug|GlucoCorticoid|"After inclusion in the study, the first part is an open follow-up period where all patients will receive 5 mg of prednisone daily for one month. After one month, if patients still have a DAS28 ≤3.2, they will be randomized into two arms: Group 1: GC tapering group / Group 2: Hydrocortisone replacement group.
~After randomisation, there are four scheduled visits: M4, M7, M9 and M12. Patients withdrawing from GC therapy will be instructed, that if they start feeling unwell during or after the GC tapering protocol they should not taper the steroid dose any further, but contact the centre responsible for the protocol. If GC induced adrenal insufficiency is confirmed or strongly suspected, GC replacement will be secured using hydrocortisone."
15985402|NCT02997592|Device|SpinCare dressing|The burn wound is dressed using the SpinCare wound dressing
15985403|NCT02997579|Procedure|patellar resurfacing|patellar component insert with cement
15985404|NCT02997566|Other|Autonomic evaluation|
15985405|NCT02997553|Drug|Indocyanine green|Each patient receive injection of indocyanine green just before surgery Specify total dose : 2.5 mg/ml (Intravenous use)
15985406|NCT02997553|Drug|Technetium99|"Each patient receives injection of Technetium 99 ( injected in subcutaneously) before surgery.
~Lymphoscintigraphy is performed to identify the sentinel node"
15985407|NCT02997553|Device|Optonuclear probe|The detection of sentinel lymph node will be conducted by an optonuclear probe able to detect the radioactive and the fluorescence signal during surgery.
15985408|NCT02997553|Device|Quest Camera|The detection of sentinel lymph node will be conducted by a camera able to determine imagery of fluorescence during surgery.
15985409|NCT02997527|Device|Intraluminal Impedance|Esophageal impedance testing measures epithelial integrity as reflected through the ability of the mucosa to conduct electric current. Recently, a site specific endoscopically placed impedance probe has been developed that can measure esophageal mucosal impedance at any point of the esophagus.
15985410|NCT02997514|Behavioral|Solution Focused Coaching|SFC is an approach that uses strategic questioning to help the client envision what they would like to be different and how they will take action towards achieving their goals.
15985411|NCT02997514|Behavioral|Intensive Solution Focused Coaching|Intensive SFC is an approach that uses strategic questioning to help the client envision what they would like to be different and how they will take action towards achieving their goals.
15985412|NCT02997501|Procedure|T790M+ Testing|The patient will need to have T790M+ testing
15985413|NCT02997501|Procedure|Baseline Visit Blood & Urine Testing|Blood count and standard chemistry testing to ensure patient meets inclusion/exclusion criteria
15985414|NCT02997501|Procedure|Baseline ECG|ECG to ensure absence of any cardiac abnormality
15985415|NCT02997501|Procedure|Visual Slit-Lamp Testing|Slit-lamp testing performed to ensure patients do not have any eye abnormalities or symptoms
15985416|NCT02997501|Drug|AZD9291 Dosing|Patients to be provided with AZD9291 every 6 weeks (+/- 7 days)
15985417|NCT02997501|Procedure|Plasma AZD9291 testing|The patient will need to have plasma AZD9291 testing before treatment
15985418|NCT02997488|Device|Pentax Airwayscope|intubation using Pentax Airwayscope
15985419|NCT02997488|Device|McGrath Videolaryngoscope|intubation using McGrath Videolaryngoscope
15985424|NCT02997397|Procedure|tourniquet(+)|A novel atraumatic tourniquet technique, applied via placing a vascular clamp widely on both the infundibulopelvic ligament and uterine arteries.
15985425|NCT02997397|Procedure|tourniquet(-)|
15985426|NCT02997384|Other|Information|information of women about their risk of breast cancer and the screening methods recommended for them
15985427|NCT02997371|Drug|Anakinra Prefilled Syringe|Administration as initially intravenous injection followed by a intravenous infusion
15985428|NCT02997371|Drug|Isotonic saline|Placebo, administration as initially intravenous injection followed by a intravenous infusion
15985429|NCT02997358|Drug|Doxorubicin|
15985430|NCT02997358|Drug|Trabectedin|
15985431|NCT02997345|Other|There is no intervention associated with this study.|There is no intervention associated with this study.
15985432|NCT02997332|Drug|Durvalumab|Durvalumab will be administered every 3 weeks for 3 injections at week 1, 4, 7. Dose levels: the durvalumab first dose level is 1120 mg Q3W, and the dose level -1 is 750 mg Q3W.
15985433|NCT02997332|Drug|Docetaxel|Docetaxel 75mg/m² on D2, IV in 1 hour
15985434|NCT02997332|Drug|Cisplatin|Cisplatin 75mg/m² on D2, IV in 3 hours
15985435|NCT02997332|Drug|5 Fluorouracil|5 Fluorouracil 750mg/m²/day on D2, D3, D4, D5, D6 IV in 24 hours
15985436|NCT02997306|Procedure|Superior/Medial Running Sutures|Simple interrupted stitches and running (continuous) stitches are the two most frequently used suturing techniques. The erythema secondary to these suturing techniques will be compared by utilizing them side-by-side for closure of post-Moh's surgical defect repair in each patient. This intervention consists of running sutures being used for closure of the Superior/Medial half of the incision, and interrupted sutures being used on the Inferior/Lateral half of the incision.
15985437|NCT02997306|Procedure|Inferior/Lateral Running Sutures|Simple interrupted stitches and running (continuous) stitches are the two most frequently used suturing techniques. The erythema secondary to these suturing techniques will be compared by utilizing them side-by-side for closure of post-Moh's surgical defect repair in each patient. This intervention consists of running sutures being used for closure of the Inferior/Lateral half of the incision, and interrupted sutures being used on the Superior/Medial half of the incision.
15985438|NCT02997293|Other|Enhanced Recovery protocol|The Enhanced Recovery protocol focuses on many areas or perioperative care, including non-narcotic pain management, optimization of fluid balance throughout the perioperative course, early eating, ambulation, early removal of drains postoperatively, and preoperative patient education.
15985439|NCT02997280|Drug|Ruxolitinib Oral Tablet|"Dose reduction criteria for acute GVHD: grade 4 neutropenia or grade 4 thrombocytopenia related to ruxolitinib administration based on the decision of attending physician.
~Dose reduction criteria for chronic GVHD: grade 3 neutropenia, grade 3 thrombocytopenia or anemia requiring transfusion, related to ruxolitinib administration based on the decision of attending physician.
~Reduced dose schedule: 5 mg bid for adults and children with body weight > 40 kg, 0.08 mg/kg bid for children with body weight < 40 kg.
~Treatment discontinuation criteria: complete response; absence of response after 28 days or progressive disease after 7 days for acute GVHD; absence of response after 84 days or progressive disease after 28 days for chronic GVHD; life-threatening complications."
15985440|NCT02997267|Procedure|Closure of the ileostomy|Surgical closure of the protective ileostomy (reconnection of intestinal loops)
15985441|NCT02997241|Biological|OncoCare|Personalized monitoring
15985442|NCT02997241|Drug|chemotherapy for colorectal carcinoma|chemotherapy for colorectal carcinoma
15985450|NCT02997215|Drug|Lidocaine|lidocaine infusion during surgery
15985451|NCT02997215|Drug|Saline Placebo|saline infusion at same rate as intervention group during surgery
15985452|NCT02997202|Drug|gilteritinib|oral
15985453|NCT02997202|Drug|Placebo|oral
15985454|NCT02997189|Drug|OTO-104|12 mg dexamethasone administered intratympanically
15985455|NCT02997176|Drug|Talazoparib|Daily oral doses of talazoparib 0.5 mg
15985456|NCT02997163|Drug|Talazoparib|Daily oral doses of talazoparib 0.5 mg
15985457|NCT02997150|Drug|IL-2 Low dose|"Patients receive low doses of Interleukin 2: 0.5 million UI/m²/ injection subcutaneously.
~The treatment is initiated with an induction phase of one injection per day for 5 consecutive days, followed by a maintenance phase in which patients will receive one injection every 14 days for 6 months.
~At the same time, corticoid treatment will be tapered until its complete withdrawal no later than 3 months from the first injection"
15985458|NCT02997137|Dietary Supplement|BOT-01|"Amino acid composition with micronutrients, once a day (in the morning) content of a sachet mixed with 200 ml water.
~Duration: 12 weeks"
15985459|NCT02997137|Other|Placebo|"Placebo, once a day (in the morning) content of a sachet mixed with 200 ml water.
~Placebo contains no amino acids and micronutrients and is identical in appearance and solution properties.
~Duration: 12 weeks"
15985460|NCT02997124|Procedure|local infiltration and TAP block|Local infiltration of the iliac crest harvest site along with TAP block using 0.2 % Ropivacaine is done
15985461|NCT02997124|Procedure|local infiltration only|Only local infiltration with 0.2% Ropivacaine of the iliac crest harvest site is done.
15985462|NCT02997111|Device|PFA-100|The PFA-100 will be used to assess platelet function before and after energy drink consumption.
15985463|NCT02997085|Device|Live-Action 360° Video Virtual Reality|360° Video Virtual Reality (VVR) is made by filming with multiple HD cameras carefully arranged to capture all angles in a 360° area of a live action event. Then those angles are stitched together in post-production into a 360-degree texture sphere and the sphere is then mapped to the head tracker on the users head mounted display (HMD). Leading to the effect that when a user turns his head, the user's view of the live action video footage turns with them in real time allowing the user to look around anywhere in the 360 degrees of filmed footage of the live action event. Participants randomized to the Live-Action 360° VVR group will be outfitted with a Samsung Gear VR HMD and will view a 9-minute live-action 360° VVR video. The 9 minutes of footage will be alternating 30 second clips of central Texas locations.
15985548|NCT02996409|Other|Progressive exercise program|A 12-week during progressive exercise training program consisting of isometric, isotonic and eccentric calf exercises.
15985464|NCT02997085|Device|CGI 360° Video Virtual Reality|Participants randomized to the CGI 360° VVR condition will also be outfitted with a Samsung Gear VR head mounted display. Participants will view the same content for the same duration as in the Live-Action 360° VVR condition, but the footage will be animated instead of live-action footage.
15985465|NCT02997059|Drug|Fluconazole|200 mg/ day
15985466|NCT02997059|Other|Placebo|
15985467|NCT02997033|Other|No intervention|No intervention
15985468|NCT02997020|Other|EDSPD|The equipment & conditions for measuring bioelectric changes across the sinus mucosa are based on the standard NPD protocol, including use of agar-filled PE90 tubing for the probing electrode and limiting perfusion solutions to Ringer, Ringer + amiloride (100 µM), chloride-free gluconate with amiloride + isoproterenol (10 µM). The potential difference will be monitored in actively inflamed areas as judged by endoscopy in comparison to an agar-filled reference butterfly electrode placed in the volar aspect of the forearm. A stable potential with the mean value of a 10-s scoring interval after perfusion of each solution will be recorded by a blinded investigator.
15985469|NCT02997007|Device|active tDCS|Participants will receive active tDCS over the angular gyrus on five consecutive days
15985470|NCT02997007|Device|sham tDCS|Participants will receive sham tDCS over the angular gyrus on five consecutive days
15985471|NCT02996968|Procedure|Self-removal|Self-discontinuation of a transurethral catheter
15985472|NCT02996955|Behavioral|social support|behaviour change intervention
15985473|NCT02996955|Behavioral|treatment of illness perceptions|educational interview
15985474|NCT02996955|Device|Activ8|wearing a move monitor
15985475|NCT02996955|Other|activity advice|walking or cycling 5 days a week during at least half an hour
15985476|NCT02996942|Biological|Factor VIII replacement|Patients receive their usual treatment
15985477|NCT02996929|Device|LC System|Subjects will undergo CIED lead extraction with the LC system
15985478|NCT02996916|Drug|Olmesartan|10-40mg daily
15985479|NCT02996916|Drug|Amlodipine|2.5-10mg daily
15985480|NCT02996890|Biological|MV-ZIKA|MV-Zika vaccine
15985481|NCT02996890|Other|Placebo|physiological saline
15985482|NCT02996864|Other|Healthy Detours App|"The app features:
~Immediate and relevant feedback at the point of decision-making to reinforce healthy lifestyle behaviors within a population making crucial lifestyle choices.
~User-centered and location-specific tailored information to provide users with information to improve future decision-making through activity tracking.
~Multiple health-tracking features (i.e., diet and PA tracking, and accelerometry for PA and sleep) that will aid in self-monitoring."
15985483|NCT02996864|Other|Fat Secret App|Freely available app for weight loss and nutrition. Includes food and exercise diaries; calorie counting.
15985484|NCT02996838|Drug|TQ-B3234|TQ-B3234 p.o. qd
15985485|NCT02996825|Drug|Gemcitabine|Given IV
15985486|NCT02996825|Drug|Gemcitabine Hydrochloride|Given IV
15985487|NCT02996825|Other|Laboratory Biomarker Analysis|Correlative studies
15985488|NCT02996825|Biological|Mirvetuximab Soravtansine|Given IV
15985489|NCT02996825|Other|Pharmacological Study|Correlative studies
15985490|NCT02996812|Drug|Exendin (9-39)|
15985491|NCT02996799|Other|Umbilical cord milking|Milking of the umbilical cord at delivery
15985492|NCT02996786|Dietary Supplement|Danggui Buxue Tang|Danggui Buxue Tang purchased from Kaiser Pharmaceutical
15985493|NCT02996786|Other|Placebo|Consisting of corn starch and carboxymethyl cellulose
15985494|NCT02996773|Drug|Bendamustine|After transplant, given intravenously on day +4 as part of Phase Ib.
15985495|NCT02996773|Drug|Cyclophosphamide|After transplant, given intravenously on day +3 as part of Phase 1b.
15985496|NCT02996760|Drug|Growth Factor, Platelet-Derived|0,5 mL, vaginal use , 3 dose number
15985497|NCT02996747|Procedure|curettage (intralesional surgery)|comparison of two different tumors treated by curettage
15985498|NCT02996734|Procedure|curettage and resection|the investigators analyzed patients with giant cell tumor of bone who underwent curettage or resection with or without denosumab administration
15985499|NCT02996721|Biological|Vitamin D3|Vitamin D3 (cholecalciferol) will be provided to participants of the study.
15985500|NCT02996695|Drug|Artesunate|Artesunate is a succinic ester of artemether.
15985501|NCT02996695|Drug|Chloroquine|4-aminoquinolone, antimalarial agent for oral administration
15985502|NCT02996695|Biological|PfSPZ (NF54) Challenge|Cryopreserved Plasmodium falciparum (Pf) fully infectious sporozoites (SPZ) that have been developed to be used to infect volunteers in controlled human malaria infection (CHMI) to assess the efficacy of antimalarial drugs and vaccines. The PfSPZ (NF54) Challenge contains a laboratory malaria strain isolated from a Dutch traveler to Africa.
15985503|NCT02996695|Other|Placebo|Placebo
15985504|NCT02996682|Drug|SOF/VEL|400/100 mg FDC tablet administered orally once daily
15985505|NCT02996682|Drug|RBV|Capsules administered orally in a divided daily dose
15985506|NCT02996656|Drug|Cefazolin|Antibiotic that will be give before a Trauma or elective open shoulder surgery
15985507|NCT02996656|Drug|Ceftriaxone|Antibiotic that will be give before a Trauma or elective open shoulder surgery
15985508|NCT02996643|Device|Ultrasound Assisted Group|A custom brace standing frame, a medical ultrasound system, a custom pressure measurement system, and in-house Ultrasound measurement software were used to assist brace casting for the intervention group.
15985509|NCT02996630|Procedure|Sonography|Fetal Ultrasound exploration
15985510|NCT02996630|Device|Magnetic Resonance Imaging|Fetal MRI for brain study
15985511|NCT02996630|Other|Bailey Test|Neurodevelopment paediatric assessment test performed at 2 years of age.
15985512|NCT02996630|Procedure|Surgical intervention|Congenital Heart Disease repair
15985513|NCT02996630|Procedure|Brain monitoring|EEG and continuous brain oximetry before surgery.
15985514|NCT02996630|Procedure|cord blood sample|Cord blood samples will be taken after birth in both groups.
15985545|NCT02996422|Behavioral|Community cooking classes|Cooking classes will be delivered to groups of 8-12 adult participants as a series of 8 weekly classes in community venues. The content of each class is driven by topics and themes identified and prioritized by community members, namely cooking healthy on tight budget.
15985546|NCT02996409|Drug|HVIGI|High Volume Image-Guided Injection with a saline/lidocain solution
15985621|NCT02995889|Device|FLT-PET|
15985515|NCT02996617|Drug|rhG-CSF regimen|Patients weren't preventive use of rhG-CSF.If their WBC≤1×10^ 9/L,they were administered rhG-CSF:5ug/kg/day until their WBC≥4×10^ 9/L.Chemotherapy regimen: CHOP: Epirubicin：70 mg/m2 , Cyclophosphamide：750 mg/m2, Vincristine: 1.4 mg/m2 , Prednison：100mg/d; CHOPE: Epirubicin：70 mg/m2, Cyclophosphamide：750 mg/m2,Vincristine: 1.4 mg/m2,Prednison：100mg/d,Etoposide: 100 mg/（m2•d）;EPOCH:etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin;Hyper-CVAD(A):hyperfractionated cyclophosphamide, vincristine,doxorubicin, dexamethasone, cytarabine and methotrexate;GemOx-R:Gemcitabine, Oxaliplatin;GDP:gemcitabine, dexamethasone, and cisplatin
15985516|NCT02996617|Drug|Pegylated rhG-CSF regimen|Patients were administered pegylated rhG-CSF 6mg（weight≥45Kg）or 3mg（weight≤45Kg）once 24 hours after the end of chemotherapy drugs of every chemotherapy cycle.Chemotherapy regimen: CHOP: Epirubicin：70 mg/m2 , Cyclophosphamide：750 mg/m2, Vincristine: 1.4 mg/m2 , Prednison：100mg/d; CHOPE: Epirubicin：70 mg/m2, Cyclophosphamide：750 mg/m2,Vincristine: 1.4 mg/m2,Prednison：100mg/d,Etoposide: 100 mg/（m2•d）;EPOCH:etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin;Hyper-CVAD(A):hyperfractionated cyclophosphamide, vincristine,doxorubicin, dexamethasone, cytarabine and methotrexate;GemOx-R:Gemcitabine, Oxaliplatin;GDP:gemcitabine, dexamethasone, and cisplatin
15985517|NCT02996604|Other|acupuncture|Manual acupuncture treatment will be conducted. thirty minutes duration every time, five times per week for one course, a total four courses.
15985518|NCT02996591|Procedure|25 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for popliteal nerve block|
15985519|NCT02996591|Procedure|10 mL of 0.25% bupivacaine plus 2 mg preservative-free (PF) dexamethasone / 30 ml for adductor canal nerve block|
15985520|NCT02996591|Drug|Midazolam, 2-5 mg IV + Glycopyrrolate, 0.1 mg IV + Ketamine, 10-20 mg + propofol as needed|
15985521|NCT02996591|Procedure|45-60 mg of 1.5% mepivacaine for spinal anesthesia|
15985522|NCT02996591|Procedure|LMA insertion + titrated propofol infusion + sevoflurane + ketamine 10 mg/hr for general anesthesia|
15985523|NCT02996578|Dietary Supplement|polyphenol rich chocolate bar|High polyphenol content chocolate bar. Each participant will consume 581.4mg of polyphenols
15985524|NCT02996578|Dietary Supplement|polyphenol rich cocoa powder|High polyphenol content cocoa powder. Each participant will consume 6g containing 554mg of polyphenols
15985525|NCT02996578|Dietary Supplement|low polyphenol content chocolate bar|Low polyphenol content matched chocolate bar. Each participant will consume 198.5mg of polyphenols
15985526|NCT02996578|Dietary Supplement|low polyphenol content cocoa powder|Low polyphenol content cocoa powder. Each participant will consume 6g containing 191.2mg of polyphenols
15985527|NCT02996565|Other|Best Practice Clinic-Based Care|"Relies primarily on the physician-medical assistant dyad and face-to-face visits to promote:
~Improved recognition of uncontrolled BP at primary care encounters,
~Therapeutic action to address uncontrolled BP at primary care encounters,
~Reliable follow-up visits to re-assess uncontrolled BP every 2-4 weeks."
15985528|NCT02996565|Other|Telehealth Care|"All elements of Clinic-Based Care are performed, plus a telemonitoring and pharmacist case management program is offered, specifically:
~Referral to care by MTM pharmacist or Nurse Practitioner and receiving a home blood pressure telemonitoring device
~Systematic home BP telemonitoring with data transmitted into patient medical record
~Systematic home-based care by pharmacist or nurse practitioner via telephone and/or secure email"
15985529|NCT02996552|Procedure|M & T Repair Group|After the mitral valve repair a device for tricuspid annuloplasty will be implanted.
15985530|NCT02996552|Procedure|Mitral-Only Group|Mitral valve repair alone; after the mitral valve repair no device for tricuspid annuloplasty will be implanted.
15985531|NCT02996539|Other|Clinical examination and laboratory measurements|Subjects were interviewed by a physician regarding their medical history, history of hypoglycemic attacks, smoking status, and alcohol consumption. Concentrations of blood urea nitrogen (BUN) and serum creatinine (SCr) were analyzed by the urease-ultraviolet rate method and picric acid method, respectively. Serum uric acid was determined using the enzymatic colorimetric method. Serum hemoglobin A1c (HbA1c) was measured by liquid enzymatic assay. Urine albumin and urine creatinine were found through immune turbidimetric analysis and the enzymatic method, respectively.
15985532|NCT02996513|Other|Retinol Isotope Dilution (RID)|13C-retinyl acetate will be administered to subjects in order to assess their body retinol pools
15985533|NCT02996500|Drug|PF-06650833|Investigational
15985534|NCT02996500|Drug|Placebo|Placebo
15985535|NCT02996500|Drug|Tofacitinib|Investigational
15985536|NCT02996487|Drug|Vancomycin|
15985537|NCT02996487|Other|Placebo|
15985538|NCT02996474|Drug|Pembrolizumab|200 mg will be administered as a 30 minute IV infusion every 3 weeks. Every effort should be made to target infusion timing to be as close to 30 minutes as possible. However, given the variability of infusion pumps, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).
15985539|NCT02996474|Drug|Decitabine|Will be administered at a dose of 20 mg/m2 by continuous intravenous infusion over 1 hour repeated daily ordinarily on days 8 through 12 and 15 through 19 of alternative cycles (ie: cycles 1, 3, 5, 7). Decitabine should be repeated every 6 weeks.
15985540|NCT02996461|Biological|VRC-ZKADNA090-00-VP|VRC-ZKADNA090-00-VP is an investigational ZIKV DNA vaccine that is intended to prevent Zika virus infection.
15985541|NCT02996448|Drug|NDV-3A|A vaccine containing recombinant Candida albicans agglutinin-like sequence 3 (rAls3) protein as the antigen, formulated with AlOH adjuvant in phosphate buffered saline. Participants will receive a single 0.5 mL dose containing 300 micrograms of rAls3 and 0.5 mg of aluminum as AlOH, delivered via intramuscular injection.
15985542|NCT02996435|Behavioral|Mobile Application Intervention|Mobile phone application that sends reminders and allows participants to self-manage their medication adherence. Monitoring of participant adherence from this tool will be performed by the central coordinating center, which will send notifications or contact the participant based on the adherence history in accordance with the study protocol.
15985543|NCT02996435|Other|No Intervention|Participants will receive physician- or nurse-guided standard of care.
15985544|NCT02996422|Behavioral|School-based water campaign|Includes: 1) the installation of filtered water bottle refilling stations, 2) the distribution of reusable water bottles to all students and teachers, and 3) a social marketing campaign to support the increase of water consumption among students.
15985547|NCT02996409|Drug|LVIGI|Placebo control with injection of a saline/lidocain solution (low volume)
15985549|NCT02996396|Device|Nellix Endovascular Aneurysm Sealing System (Nellix®-System)|The Nellix system is comprised of two independent flow channels, one to each iliac artery. Each flow channel consists of a balloon-expanded ePTFE covered stent surrounded by a Polymer-filled EndoBag which fills the blood lumen within the aorta, and seals the aneurysm from side-branch flow.
15985550|NCT02996383|Device|Internal fixation|Internal fixation of the fracture with a Targon FN implant (BBraun Ltd, Germany)
15985551|NCT02996383|Device|Cemented Hemiarthroplasty|Replacement of the femoral head with a cemented hemiarthroplasty
15985552|NCT02996370|Other|papilla fill index|The clinical photographs were taken baseline, 3 and 6 month. Two T shaped full-round hexagonal straight filaments, each 5 mm, were used in the taking of standardized images.
15985553|NCT02996370|Other|crestal bone loss|Crestal bone loss was measured on digital radiographs at baseline, 3 and 6 month with a Java program me (Image-J 3.0 NIH, Bethesda, USA)
15985554|NCT02996370|Other|probing depth|The change of probing depth between baseline, 3 and 6month. Probing depth was measured with a plastic periodontal probe (mm)
15985555|NCT02996370|Other|Modified sulcus bleeding index|Modified bleeding index was measured baseline, 3 and 6 month. Presence of bleeding on probing were performed at four sites of implants.
15985556|NCT02996370|Other|Modified plaque index|Modified plaque index was measured baseline, 3 and 6 month. Presence of plaque index was performed at four sites of implants.
15985557|NCT02996344|Other|Didactic training|Six online training modules pertaining to suicide prevention in primary care.
15985558|NCT02996344|Other|Standardized patient interaction|Two standardized patient practice interactions - 1 face-to-face, 1 remote/telehealth.
15985559|NCT02996331|Other|2 hour repositioning|Current PrU prevention protocols recommend repositioning moderate, high, and severe risk residents a minimum of every 2 hours. We propose to include low risk residents because studies suggest they too develop PrUs. New pressure redistribution mattresses may make 2 hour repositioning unnecessary, but optimal time between repositioning remains unclear. Aim is to determine differences in incidence of new PrUs in NH residents (low, moderate, high risk level) using VE surfaces and repositioned at 2, 3, and 4 hour frequencies.
15985560|NCT02996331|Other|3 hour repositioning|It is expected that repositioning frequency can be extended for NH residents who are low, moderate, and high risk for pressure ulcer (PrU) development and on visco-elastic (VE) high-density foam support-surfaces without compromising PrU incidence. This intervention will include a 3 hour repositioning interval.
15985561|NCT02996331|Other|4 hour repositioning|It is expected that repositioning frequency can be extended for NH residents who are low, moderate, and high risk for pressure ulcer (PrU) development and on visco-elastic (VE) high-density foam support-surfaces without compromising PrU incidence. This intervention will include a 4 hour repositioning interval.
15985562|NCT02996318|Device|Paclitaxel coated balloon (SeQuent Please)|Paclitaxel coated balloon (SeQuent Please)
15985563|NCT02996318|Device|Sirolimus coated balloon|Sirolimus coated balloon
15985564|NCT02996305|Drug|OV101 Regimen 1|
15985565|NCT02996305|Drug|OV101 regimen 2|
15985566|NCT02996305|Other|Placebo|
15985567|NCT02996292|Device|Traditional brackets|Treating of crowding using traditional brackets
15985568|NCT02996292|Device|Active self-ligating brackets|Treating of crowding using active self-ligating brackets
15985569|NCT02996292|Device|Passive self-ligating brackets|Treating of crowding using passive self-ligating brackets
15985570|NCT02996266|Device|Targeted Temperature Management|Prophylactic normothermia
15985571|NCT02996266|Other|Standard Care|No intervention to control temperature unless fever occurs
15985572|NCT02996253|Procedure|FHL transfer|endoscopic transfer og flexor hallucis longus
15985573|NCT02996240|Dietary Supplement|Omega-3 FFA|Omega-3 Free Fatty Acid will be given as a fish oil in a capsule.
15985574|NCT02996227|Procedure|TAP block|Transversus Abdominis Plane (TAP) blocks will be performed preoperatively. An in-plane ultrasound will be used in TAP block procedure.
15985575|NCT02996227|Procedure|Epidural analgesia|Epidural catheters will be inserted preoperatively.
15985576|NCT02996227|Drug|EXPAREL|Once the target area is positioned, plain bupivacaine 0.25%, 20ml will be given to open the space and then single dose (10ml) of liposomal bupivacaine (Exparel) mixed with saline (10 ml) will be injected in each side. Total dose of Exparel will be 20 mL.
15985577|NCT02996227|Drug|Bupivacaine|Once an epidural catheter is successfully positioned, an infusion will be initiated intraoperatively. Bupivacaine standard solution without additives will be prepared for each patient in epidural group.
15985578|NCT02996214|Drug|Paclitaxel Liposome|Paclitaxel liposome injection 175 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles.
15985579|NCT02996214|Drug|Gemcitabine|Gemcitabine 1000 mg/m^2, given on days 1 and 8 of a 21-day cycle, for 4-6 cycles.
15985580|NCT02996214|Drug|Cisplatin|Cisplatin 75 mg/m^2, given on day 1 of a 21-day cycle, for 4-6 cycles.
15985581|NCT02996201|Other|Completion of PRO-CTCAE items before consultation|Patients report PRO-CTCAE symptoms on a tablet computer before each cycle of chemotherapy
15985582|NCT02996188|Procedure|routine therapeutic paracentesis|
15985583|NCT02996175|Behavioral|Behavioral Sleep Treatment|"Introduction to the treatment program, an overview of common sleep problems in DS, and the basic principles of the behavioral approach as it relates to sleep problems
~Information on healthy sleep hygiene, preventative techniques, and use of visual supports
~Information on reinforcement and extinction procedures for bedtime struggles, codependence, night waking, early waking
~Information on procedures for delayed sleep onset and problematic sleep associations
~Feedback on implementation of behavioral sleep treatments and strategies for managing sleep hygiene in the future"
15985584|NCT02996175|Behavioral|Standard of care sleep treatment enhanced with psychoeducation|"Introduction to the general-education program, build rapport with family, and review basic information on Down syndrome
~Introduction to understanding and interpreting results from clinical evaluations
~Introduction to educational planning, expectations, and transition planning
~Introduction to lifespan development and advocacy and support services available
~Feedback on current concerns and methods for obtaining services to manage concerns"
15985622|NCT02995876|Procedure|Glaze layer|A coating of a glaze layer will be used at the inner surface of the bridge to improve adhesion
15985623|NCT02995876|Procedure|E-max Press layer|A coating of E-max Press layer will be used at the inner surface of the bridge to improve adhesion
15985585|NCT02996162|Device|Massimo Root Monitoring System|The Masimo Root system is a patient monitoring and connectivity platform; Root displays patient monitoring information from the connected modules. This will be used as a non-invasive way to determine infants' pCO2. The equipment will be used in the inpatient portion of the study up to twice weekly for 5 minutes to obtain approximately 150 end tidal CO2 values and recorded over time for each infant. In the outpatient portion, it will be used in each clinic visit in a similar fashion.
15985586|NCT02996162|Device|ISA-Infrared Sidestream Gas Analyzer|The ISA-Infrared Sidestream Gas Analyzer displays end-tidal carbon dioxide waveforms and measurements and trends of end tidal CO2. This will be used as a non-invasive way to determine infants' pCO2. The equipment will be used in the inpatient portion of the study up to twice weekly for 5 minutes to obtain approximately 150 end tidal CO2 values and recorded over time for each infant. In the outpatient portion, it will be used in each clinic visit in a similar fashion.
15985587|NCT02996149|Procedure|Endoscopic lung volume reduction coil treatment|
15985588|NCT02996136|Device|Flu Symptoms|Flu Symptoms
15985589|NCT02996123|Other|cad/cam maxillary dentures|patients wearing cad/cam designed and milled dentures
15985590|NCT02996110|Biological|Nivolumab|
15985591|NCT02996110|Biological|Ipilimumab|
15985592|NCT02996110|Biological|Relatlimab|
15985593|NCT02996110|Drug|BMS-986205|
15985594|NCT02996110|Drug|BMS-813160|
15985595|NCT02996097|Device|The Lutronic electronic carbon dioxide (eCO2) Plus laser system|CO2 ablative laser plus intralesional triamcinolone acetonide A topical EMLA cream or tetracaine 7%/lidocaine 23% will be applied to the both treatment sites and after sufficient anesthesia is attained, one keloid will be treated with the fractional CO2 laser using standard protocol as practiced in our clinics followed by intralesional triamcinolone acetonide. One lesion would be treated with fractional CO2 ablative laser followed with intralesional triamcinolone acetonide at 4 weeks intervals
15985596|NCT02996097|Drug|Intralesional Triamcinolone Acetonide|
15985597|NCT02996071|Procedure|laparoscopic sleeve gastrectomy|a sleeve gastrectomy operation that is performed laparoscopically.
15985598|NCT02996058|Drug|Dexmedetomidine 0.35µg/kg /h|the infants will receive a maintenance dose of 0.35µg/kg /h of Dexmedetomidne without a loading dose and guided by the assessed sedation scale
15985599|NCT02996058|Drug|Dexmedetomidine 0.5µg/kg /h|the infants will receive a maintenance dose of 0.5µg/kg /h of Dexmedetomidne without a loading dose and guided by the assessed sedation scale
15985600|NCT02996045|Other|Clinical Decision Support (CDS)|"A best practices alert (BPA) pop-up screen providing CDS will appear at physician sign-off for all scans scored 1-6, and scans scored 7-8 for which an alternative scan scored 8-9 exists.
~This screen will show the appropriateness score of the original scan order, and will display up to 7 alternative scans that are scored >4 and greater than or equal to the original score for the same indications and patient characteristics. It will also display a link to relevant ACR documentation relevant to the selected scan and indication."
15985601|NCT02996032|Other|Vascular and Pulmonary Ultrasound|
15985602|NCT02996019|Drug|Etrolizumab|Etrolizumab will be administered at a dose of 105 milligrams (mg).
15985603|NCT02996019|Device|Auto-Injector (AI)|The pre-filled AI will be used to administer etrolizumab.
15985604|NCT02996019|Device|Prefilled Syringe With Needle Safety Device (PFS-NSD)|The PFS-NSD will be used to administer etrolizumab.
15985605|NCT02996006|Procedure|stepwise vascular control|"Before liver parenchymal resection, we performed total hepatic vascular preparation for occlusion with portal triad (PT), infra-hepatic inferior vena cava (IIVC), and supra-hepatic inferior vena cava (SIVC) preparation in order. Then we performed step-by-step vascular occlusion according to the individual bleeding situation."
15985606|NCT02995993|Drug|Moss-aGal (recombinant human alpha-galactosidase A produced in moss)|Single i.v. Infusion of 0.2 mg/kg moss-aGal over 60 minutes
15985607|NCT02995980|Device|Dual-Energy Contrast-Enhanced (DECE) mammography|Contrast mammography
15985608|NCT02995980|Device|digital mammography|routine digital mammography
15985609|NCT02995967|Procedure|Hydrodistention|The hydrodistention will then be performed with the bladder filled at a pressure of 80 cm H2O and noted to be full as evidenced by no further influx of water into the bladder. This volume will be held in the bladder for 5 minutes.
15985610|NCT02995967|Drug|Botulinum toxin-A|Intradetrusor injection of 100 units of botulinum toxin a
15985611|NCT02995954|Drug|Perindopril/Amlodipine|Single table containing Perindopril/Amlodipine
15985612|NCT02995928|Procedure|Decompressive craniectomy|Decompressive craniectomy: All patients in the treatment group will receive decompressive craniectomy of at least 12 cm according to institutional guidelines and a published surgical protocol during the clipping surgery within 48 hours form the onset.
15985613|NCT02995928|Procedure|Best medical treatment|Best medical treatment: Best medical treatment is based on American Heart Association/American Stroke Association (AHA/ASA) and European Stroke Organisation (ESO) as published in the current protocol from 2012 and 2013 respectively.
15985614|NCT02995915|Other|Nicotine Replacement Therapy|Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum or nicotine lozenge, and will be instructed to use the rescue method as needed to reduce cigarette cravings
15985615|NCT02995915|Drug|Bupropion|All participants who are medically eligible will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
15985616|NCT02995915|Behavioral|Cognitive Behavioral Treatment|Participants will receive 4 60-minute sessions of CBT telephone counseling for alcohol and smoking cessation.
15985617|NCT02995915|Behavioral|Mobile Contingency Management|Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence, and breathalyzer to confirm abstinence from alcohol. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for videos that suggest smoking abstinence and alcohol abstinence.
15985618|NCT02995915|Behavioral|Mobile Monitoring|Participants will be asked to provide video recordings of themselves taking carbon monoxide readings and breathalyzer. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for providing the video recordings, regardless of abstinence.
15985619|NCT02995902|Device|FLT-PET|
15985620|NCT02995902|Device|MRI|
15985626|NCT02995850|Drug|CRS+HIPEC|"Ib
~Dose-escalation of intraperitoneal paclitaxel will follow a modified 3 + 3 dose escalation procedure.
~II
~① CRS If PCI <12, CRS will be performed by gastrectomy with D2-lymphadenectomy and resection of any involved adjacent structures.
~If PCI≥12, instead of CRS, 3 times of IP paclitaxel +cisplatin and oral S-1 chemotherapy every 3 weeks, and then PCI <12, CRS will be done.
~② Extensiveintraperitoneal lavage Peritoneal lavage after CRS will be done with 10 L before HIPEC.
~③ HIPEC Following surgery HIPEC will be performed using CDDP (60 mg/m2) and PTX (P2RD mg/m2). IP chemotherapy will be performed.
~④ Post-operative intraperitoneal chemotherapy Postoperative chemotherapy will be done 8 cycles of IP paclitaxel+ cisplatin and oral S-1 after 4 weeks."
15985627|NCT02995837|Other|Sleep Study|Overnight, video-recorded sleep study will be performed in a dedicated pediatric sleep lab. Sleep architecture, apneas and hypopneas, arterial oxygen saturation and end-tidal carbon dioxide tension will be evaluated during the sleep study. Safety measures including arterial oxygen saturation using pulse oximetry, EEG and EKG will be continuously monitored during the study.
15985628|NCT02995837|Other|Neurocognitive Testing|Cognitive and behavioral measures including intelligence, attention, working memory, and processing speed will be assessed by a trained psychologist.
15985629|NCT02995837|Other|CBF During Wakefulness|Cerebral blood flow (CBF) will be measure using Diffuse optical and correlation spectroscopy (DOS/DCS), a non-significant risk device used to collect data for this study but not being tested as part of the protocol. Light sources and detectors which are embedded in a rubber pad will be attached to the subject's head in order to record right and left hemispheric cerebral blood flow, total hemoglobin concentration and tissue oxygen saturation. Measurements will be continuously recorded during the study and averaged for purposes of statistical analysis. With DOS/DCS in place, ventilatory response to hypercapnia will be determined using the rebreathing technique, a standard clinical test. While CBF is being measured, subjects will wear nose clips and sit comfortably breathing through a mouthpiece while the level of carbon dioxide is adjusted over a 3-4 minute period. Oxygen and carbon dioxide levels will be carefully monitored throughout the testing.
15985630|NCT02995837|Other|CBF During Sleep|This is the same as the CBF testing during wakefulness/daytime except that it will be done during a sleep study performed with a continuous positive airway pressure (CPAP) mask not nose clips and a mouthpiece. With DOS/DCS in place, ventilatory response to hypercapnia will be determined using the rebreathing technique. While CBF is being measured, OSAS subjects will receive an individualized positive pressure aimed at treating obstructive sleep apnea and controls will receive a standard pressure. End-tidal carbon dioxide will be measured via a port in the mask. A constant flow of carbon dioxide will be introduced to the circuit, a slowly adjusted until the patient arouses or for a maximum of 3 minutes, whichever occurs first. One trial will be attempted in each sleep stage (slow-wave sleep and rapid-eye-movement) with a minimum of 15 minute of breathing room air between challenges. Oxygen and carbon dioxide levels will be carefully monitored throughout the testing.
15985631|NCT02995824|Other|Raltegravir-based antiretroviral therapy|To analyze retrospectively the efficacy and safety of raltegravir plus 2 nucleoside reverse transcriptase inhibitors (NRTI) [lamivudine (3TC) or emtricitabine.(FTC) plus abacavir (ABC) or tenofovir (TDF)] [Group 1] versus other ART regimens including boosted PI or NNRTIs [Group 2] in 271 HIV/HCV-coinfected patients who underwent liver transplantation between 2002 and 2012 and were followed until December 2016.
15985632|NCT02995811|Other|Observational Cohort|Ultrasound assessment of 4 muscles, activity monitoring, daily global peripheral skeletal muscle strength
15985633|NCT02995798|Other|Cortical Bone thickness and Hounsfield unit (HU) numbers|Cortical Bone thickness and Hounsfield unit (HU) numbers considering BMD
15985634|NCT02995785|Other|simulation-based training|simulation-based training:The first aid skill simulation training with discussion and debriefing(75-min) and TMS online lecture(15-min).
15985635|NCT02995785|Other|traditional training|traditional training:Give TMS online lecture(15-min).
15985636|NCT02995772|Drug|Aromatase Inhibitors (Arimidex)|Comparison of efficacy with chemotherapy
15985637|NCT02995772|Drug|Tamoxifen|Comparison of efficacy with chemotherapy
15985638|NCT02995772|Procedure|SOB|Comparison of efficacy with chemotherapy
15985639|NCT02995772|Drug|FAC|Comparison of efficacy with hormonal therapy
15985640|NCT02995772|Drug|Aromatase Inhibitors (Femara)|Comparison of efficacy with chemotherapy
15985641|NCT02995772|Drug|Aromatase Inhibitors (Aromasin)|Comparison of efficacy with chemotherapy
15985642|NCT02995759|Other|Seizure Action Plan|The action plan will be electronically formatted in the EMR. After electronic creation, the primary neurologist and patient/caregiver will create a patient-specific plan.
15985643|NCT02995746|Drug|Dexamethasone|"On study visit #1 all patients will have a SD-OCT scan and measurement of baseline visual acuity. All patients will receive the 0.7mg dexamethasone intravitreal implant
~Subsequent follow-up visits will be at 1 month, 2 months, 3 months, 4 months, 5 months, and 6 months after intravitreal injection of dexamethasone implant
~Each visit will consist of measurement of visual acuity, intraocular pressure, dilated fundoscopic examination, and SD-OCT scan
~Anticipated duration of the study: 6 months"
15985644|NCT02995733|Drug|PARTICS using QVAR|Patient takes inhaled corticosteroid at the time of rescue inhaler use
15985645|NCT02995720|Drug|Fimasartan/Amlodipine combination drug, Rosuvastatin|
15985646|NCT02995707|Drug|Thalidomide|thalidomide:50mg/d p.o at bedtime
15985647|NCT02995694|Drug|Estradiol|Estradiol Vaginal Cream
15985648|NCT02995694|Drug|Placebos|Placebo with no active pharmaceutical ingredients. Topical vaginal cream
15985649|NCT02995694|Drug|Reference|Estrace Vaginal Cream
15985650|NCT02995681|Other|Balance training|Balance exercises will include: functional lower extremity training, gait training under challenging conditions and training to increase stability during changes in body positions.
15985651|NCT02995681|Other|Pulmonary rehab|Pulmonary rehab includes: supervised exercise (aerobic exercise, resistance exercise) disease-specific education, and psychological and social support.
15985652|NCT02995668|Other|Strength-Function|Preoperative functional and strength capabilities training.
15985653|NCT02995668|Other|Balance-Proprioception|Preoperative proprioceptive and balance capabilities training
15985654|NCT02995655|Drug|CX-01|CX-01 at a dose of 4mg/kg on Day 1 of each 28-day cycle, followed by a continuous intravenous infusion at a dose of 0.25 mg/kg/hour for Days 1 through 7 of each cycle.
15985655|NCT02995655|Drug|Azacitidine|Azacitidine at a dose of 75mg/m^2 on Days 1-7 of each 28-day cycle.
15985656|NCT02995655|Procedure|Bone marrow biopsy|-Baseline, day 28 of even-numbered cycle through Cycle 6, and end of study
15985657|NCT02995655|Procedure|Peripheral blood draw|-Day 1 of each cycle, day 3 of each cycle, day 7 of each cycle, day 28 of every even-numbered cycle through Cycle 6, and end of study
15985658|NCT02995642|Drug|18F-FPPRGD2|One single intravenous injection.
15985659|NCT02995642|Device|Positron emission tomography|Undergo 18F-FPPRGD2 PET/CT or PET/MRI
15985660|NCT02995642|Procedure|Computed tomography|Undergo 18F-FPPRGD2 PET/CT or PET/MRI
15985661|NCT02995642|Device|Magnetic Resonance Imaging|Undergo 18F-FPPRGD2 PET/CT or PET/MRI
15985662|NCT02995629|Procedure|laser indirect ophthalmoscopy pan retinal photocoagulation|"Prior to procedure, eligible patient is dilated and a topical anesthesia is administered 3 to 5 minutes prior to treatment initiation
~Treatment duration is fixed at 50 minutes and power is titrated until moderate gray-white burns are achieved, avoiding long ciliary nerves
~Target treatment of 250 spots
~Only one eye per eligible patient randomized with regard to whether green or yellow laser utilized first
~After treatment,pain assessment conducted:spot count, laser parameters and treatment duration recorded for each respective laser wavelength"
15985663|NCT02995616|Device|Regular therapy settings|Patients will walk in the Lokomat according to their regular therapy settings for a minimum of 20 minutes (i.e. minimum tolerable guidance force (GF), minimal tolerable body weight support (BWS) and maximum tolerable walking speed)
15985664|NCT02995616|Device|100% guidance force|Patients will walk in the Lokomat with 100% GF for a minimum of 20 minutes (same amount of body weight support and walking speed as in the first session)
15985665|NCT02995616|Device|60% guidance force|Patients will walk in the Lokomat with 60% GF for a minimum of 20 minutes (same amount of body weight support and walking speed as in the first session)
15985666|NCT02995603|Device|Nano-X patient rotation|Patients are required to completed validated questionnaires to quantify their experience of horizontal rotation.
15985667|NCT02995590|Drug|Hyperpolarized He3|Hyperpolarized Helium can be used as a Contrast Agent for Lung Images using MRI.
15985668|NCT02995577|Other|Feeding tolerant|
15985669|NCT02995577|Other|Feeding intolerant|
15985670|NCT02995577|Other|Necrotizing enterocolitis|
15985671|NCT02995564|Behavioral|social skills therapy|Sixteen week manual based social skills curriculum targeting social fluency and responsiveness.
15985672|NCT02995551|Procedure|Arthroscopic meniscal repair or resection|Arthroscopic meniscal repair or resection following standard procedures.
15985673|NCT02995551|Behavioral|Exercise and education|A 12-week (2 exercise sessions per week) supervised neuromuscular and strengthening exercise program tailored to 18-40 years old patients with a meniscal tear combined with patient education teaching the participants about their disease and how to manage it through exercise and in their daily life.
15985674|NCT02995512|Drug|Colchicine 0.6 mg tablets|1.2 mg PO followed by 0.6 mg PO 1 hour later
15985675|NCT02995486|Other|Exercise|Otago Exercise Program for falls prevention after discharge due to fall-related injuries.
15985676|NCT02995473|Drug|NP000888|270 µg/g topical (BID) for 24 weeks
15985677|NCT02995473|Drug|Vehicle|Topical (BID) for 24 weeks
15985678|NCT02995460|Behavioral|interval training|4x4 high intensity interval training
15985679|NCT02995447|Other|differences between surface and intracerebral EEG|No intervention is performed. Im- and explantation of intracerebral electrodes is performed for clinical and not for study purposes. The only difference between study and non-study patients is that the surface as well as the intracerebral EEG is recorded and stored in the former, while it is discarded in the latter.
15985680|NCT02995434|Device|Virtual Reality Headset|"The following VR experiences will be used:
~Virtual Meditative Walk:http://painstudieslab.com/projects/virtual-meditative-walk/ Qualia: Zen Eagle:http://www.mobiointeractive.com/big-picture/index.html Obduction: http://obduction.com/ Carpe Lucem: http://store.steampowered.com/app/433700/Carpe_Lucem__Seize_The_Light_VR/"
15985681|NCT02995434|Other|2D PC|"The control group will be exposed to 2D equivalent versions of the same multimedia experiences but on their PC screen (without the VR headset use). These will be functionally similar to the VR experiences. These will include:
~Virtual Meditative Walk:http://painstudieslab.com/projects/virtual-meditative-walk/ Qualia: Zen Eagle:http://www.mobiointeractive.com/big-picture/index.html Obduction: http://obduction.com/ The Witness: http://store.steampowered.com/app/210970/"
15985682|NCT02995408|Behavioral|Relaxation Response Resiliency Program for Parents of Children with ASD|
15985683|NCT02995395|Device|Mucosal Impedance Balloon catheter|"During the clinical endoscopy (a standard procedure that allows your doctor to look at the inside of your swallowing tube), the 2 mm catheter (tiny tube), called an Intraluminal Impedance Balloon, will be passed through the channel of the standard endoscope.
~o The catheter (tiny tube) will be placed through the endoscope in your esophagus (swallowing tube) for two minutes, readings from the catheter will be recorded."
15985684|NCT02995382|Procedure|Anterior Intramuscular Transposition|Anterior intramuscular transposition technique to decompress the ulnar nerve at the level of the elbow
15985685|NCT02995369|Device|Dryshield|DryShield (DS) is an all-in-one isolation system. It combines the tasks of fluid evacuation, tongue and cheek retraction, and serves as a bite block. Its design allows it to suction and isolate half the oral cavity at a time.
15985686|NCT02995369|Other|Cotton rolls|Cotton Roll Isolation requires placing cotton rolls along the buccal mucosa, especially over the parotid glands ducts for maxillary teeth. For the mandibular teeth, the cotton rolls are placed in the buccal vestibule and the floor of the mouth (between the lower buccal mucosa and underneath and/or between the tongue). With this technique, a high-speed evacuation of saliva and water is used.
15985687|NCT02995356|Other|Collecting cervical liquid and sera samples|
15985688|NCT02995343|Procedure|Hypogastric and/or uterine artery ligation|
15985689|NCT02995330|Procedure|Bone marrow transplantation|Infused with non-T-cell depleted bone marrow from a related female donor on Day 0
15985690|NCT02995330|Drug|Cytoxan|Cytoxan 50mg/kg IV on Days +3 and +4
15985691|NCT02995330|Drug|testosterone cypionate|testosterone cypionate 400 mg IM will be administered on Day +60, +90, and +120 (every 30 days x 3 doses)
15985692|NCT02995317|Other|Number of falls based on an one year follow-up|
15985693|NCT02995304|Drug|Morphine premedication|30 children will 0.1 mg/kg morphine as a premedication 20 to 30 min before surgical incision.
15985694|NCT02995304|Drug|Midazolam premedication|All children who will receive 0.025 mg/kg midazolam IV as a premedication 20 to 30 min before surgical incision.
15985695|NCT02995304|Drug|Saline premedication (placebo)|30 children in midazolam only group will receive saline after midazolam
15985696|NCT02995291|Drug|OraVerse|1.7ml OraVerse (0.4 mg phentolamine mesylate) will be injected once after the participants are found to be well anesthetized following an injection of 1.8ml Bupivacaine 0.5% (inferior alveolar nerve block). Oraverse will be injected at the same site Bupivacaine was injected.
15985697|NCT02995291|Drug|Saline Water (Control)|1.7ml saline water will be injected once after the participants are found to be well anesthetized following an injection of 1.8ml Bupivacaine 0.5% (inferior alveolar nerve block). The water will be injected at the same site Bupivacaine was injected.
15985698|NCT02995278|Other|Does not include a drug needing FDA approval and therefore it is not by definition, a Clinical Drug Trial as defined by FDA.|
15985699|NCT02995265|Device|Exoskeleton Program|Subjects will wear the exoskeleton device at each physiotherapy session to work on improving mobility and walking ability.
15985700|NCT02995265|Other|Usual Care Program|Subjects will receive hands-on physiotherapy to improve their mobility and walking ability. Physiotherapy session will be tailored to subject individually by their therapist.
15985701|NCT02995252|Other|Blood draws|
15985702|NCT02995252|Drug|Tenofovir Alafenamide|25 mg tablet, once a day by mouth.
15985703|NCT02995252|Other|Knowledge Index Questionnaire|
15985704|NCT02995252|Other|Liver transient elastography (FibroScan)|Participants of the hepatitis B treatment sub-study may have FibroScans completed at baseline, during the study with liver enzyme normalization, and at the end of the study.
15985705|NCT02995252|Procedure|Liver Biopsy|40 participants of the hepatitis B treatment sub-study will have liver biopsies prior to starting tenofovir alafenamide, and at years 1 and 2 of receiving treatment.
15985706|NCT02995239|Drug|CJ-12420 formulation 2|CJ-12420 formulation 2
15985707|NCT02995239|Drug|CJ-12420 formulation 1|CJ-12420 formulation 1
15985708|NCT02995226|Other|Clinical and biological examination, Saliva (or blood) test Glycemia, thermal test, cognitive and bike tests, questionnaires|Clinical and biological examination, Saliva (or blood) test, glycemia, thermal test, cognitive and bike tests, questionnaires
15985709|NCT02995226|Other|Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnaires|Clinical examination, Glycemia, saliva (or blood) test, thermal test, cognitive and bike tests, questionnaires
15985710|NCT02995213|Behavioral|Accelerometer based feedback about paretic arm use|
15985711|NCT02995200|Behavioral|Accelerometer Based Feedback|
15985712|NCT02995187|Drug|Apatinib Mesylate tablet|Apatinib 500 mg in tablet once daily
15985713|NCT02995174|Device|Dichoptic video game in an i-Pod touch device|Amblyope will wear a pair of red green goggles and play the video game with 'contrast-balanced' images displayed on the screen of an i-Pod touch device. The eye with weaker eyesight will see the image with high contrast, and the good eye will see the image with low contrast. The subject will play the game one hour per day for 6 weeks.
15985714|NCT02995174|Device|Video game in an i-Pod touch device|Amblyope will wear a pair of red green goggles and play the video game with equal contrast images displayed on the screen of an i-Pod touch device. Both eyes will see the image of same contrast. The subject will play the game one hour per day for 6 weeks.
15985715|NCT02995161|Drug|BAY987521|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z43-106)
15985716|NCT02995161|Drug|SPF control|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
15985717|NCT02995148|Drug|BAY987521|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z43-104)
15985718|NCT02995148|Drug|SPF Control|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
15985719|NCT02995135|Drug|BAY987517|"Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
~(Formulation Code: Z43-094)"
15985720|NCT02995135|Drug|SFP Control|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
15985721|NCT02995122|Drug|BAY987516|"Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
~(Formulation Code: Z43-090)"
15985722|NCT02995122|Drug|SPF Control|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
15985723|NCT02995109|Drug|BAY987521|"Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
~(Formulation Code: Z11-004)"
15985724|NCT02995109|Drug|SPF Control|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
15985725|NCT02995096|Procedure|Pre-treatment|Non-transplantation pre-treatments prior to transplantation (e.g. radiofrequency ablation, transcatheter arterial chemoembolization)
15985726|NCT02995096|Drug|Sirolimus based immunosuppression|Immunosuppression regimens containing Sirolimus
15985727|NCT02995083|Drug|40 mg Depo-Medrol in 1 ml, 9 ml of 1% lidocaine|Patients will receive an ultrasound guided intra-articular injection of 40 mg Depo-Medrol in 1 ml, 9 ml of 1% lidocaine
15985728|NCT02995083|Drug|Normal Saline 10 ml|Patients will receive an ultrasound guided intra-articular injection of Normal Saline 10 ml
15985729|NCT02995083|Drug|Air 10 ml|Patients will receive an ultrasound guided intra-articular injection of Air 10 ml
15985730|NCT02995070|Procedure|CTG|Periodontal plastic surgery for root coverage by the trapezoidal flap plus connective tissue graft
15985731|NCT02995070|Device|LLLT|Low Level Laser Therapy on the buccal recipient site of connective tissue graft.
15985732|NCT02995070|Device|SHAM|Simulation of GaAlAs laser to irradiation on connective tissue graft recipient site.
15985733|NCT02995057|Device|Gold- or silver-coated, or uncoated nickel microneedles|The stratum corneum of the participants will be breached with the gold- and silver-coated, or uncoated nickel microneedles.
15985734|NCT02995044|Drug|BAY987521|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z09-180)
15985735|NCT02995044|Drug|SPF Control|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
15985736|NCT02995031|Drug|BAY987521|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z09-177)
15985737|NCT02995031|Drug|SPF Control|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
15985738|NCT02995018|Drug|BAY987521|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z09-174)
15985739|NCT02995018|Drug|SPF Control|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
15985740|NCT02995005|Drug|Tenofovir Disoproxil Fumarate|300 mg daily
15985741|NCT02994992|Drug|BAY 987516|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z46-100)
15985742|NCT02994992|Drug|SPF Control|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
15985743|NCT02994979|Other|Delirium-prevention|"Patients will be seen by an intervention CNA at least once daily 7 days a week. The CNA will be English/Spanish bilingual and will provide intervention components guided by structured protocols and a daily visit form. A typical visit lasts 30 minutes and begins with an introduction and orientation activity followed by provision of water, a reminiscence activity or game, a physical exercise, and a snack and second cup of water. Patients may also receive a relaxation visit at night and given a warm drink, a hand or foot massage, and quiet music. Daily visits will last for the duration of the illness and 7 days following the illness end. Illness end is defined as the last day of illness treatment (e.g., last day of antibiotics) or monitoring (e.g., last day on nursing 24-hour report). During weekly intervention staff meetings patients will be discussed with the primary medical and nursing team. The planned intervention group sample size results in a case load of 4-8 patients."
15985744|NCT02994979|Other|Sham comparator|Usual care plus sham visits by CNA
15985745|NCT02994966|Device|Surrosense|
15985746|NCT02994966|Other|Standard care|
15985747|NCT02994953|Drug|Avelumab|Subjects will receive avelumab intravenous (IV) infusion once a week on Day 1 and Day 15 of each cycle.
15985748|NCT02994953|Drug|M9241|Subjects will receive Subcutaneous (SC) injection of M9241 in escalating doses on Day 1 of each cycle.
15985749|NCT02994953|Drug|Avelumab (Once weekly)|Subjects will receive avelumab once weekly in combination with M9241 every 4 weeks at M9241 maximum tolerated dose (MTD) for first 12 weeks followed by avelumab once every 2 weeks plus M9241 once every 4 weeks at M9241 MTD until a criterion for treatment discontinuation has been met.
15985750|NCT02994953|Drug|M9241 (MTD)|Subjects will receive M9241 at M9241 MTD once every 4 weeks until a criterion for treatment discontinuation has been met.
15985751|NCT02994953|Drug|Avelumab (Expansion cohort)|Subjects in the expansion cohorts will receive Induction Therapy (Avelumab once weekly + M9241 once every 4 weeks) through Cycle 3 (for 12 weeks) then starting at Cycle 4, Continuation Therapy (Avelumab once every 2 weeks + M9241 once every 4 weeks).
15985752|NCT02994940|Drug|Acetaminophen|already included in arm/group descriptions
15985753|NCT02994927|Drug|CCX168|Orally administered
15985754|NCT02994927|Drug|Prednisone|Orally administered
15985755|NCT02994927|Drug|Cyclophosphamide|Orally or intravenously administered
15985756|NCT02994927|Biological|Rituximab|Intravenously administered
15985757|NCT02994927|Drug|Azathioprine|Orally administered
15985758|NCT02994914|Other|Onco Geriatric Evaluation|"Seven tests will be performed by an onco geriatrician : Activities of Daily Living, Instrumental Activities Of Daily Living, Mini Mental State Examination, mini Geriatric Depression Scale, Mini Nutritional Assessment, Cumulative Illness Rating Scale-Geriatric, and  timed get up and go  tests. Those tests lead to a score, and this score will determine the scheme of patients radiotherapy."
15985759|NCT02994888|Drug|Cetuximab|All patients will be offered cetuximab 500mg/m2 every 2 weeks, until the time of progression
15985760|NCT02994875|Dietary Supplement|N-acetylcysteine|NAC is an FDA-approved dietary supplement with antioxidant properties that is available over-the-counter. NAC has no contraindications.
15985761|NCT02994875|Other|Placebo|Sugar pill
15985762|NCT02994862|Other|Galla Chinnesis|new Remineralizing Agent before Bonding to teeth with amelogenesis imperfecta
15985763|NCT02994862|Other|Conventional Bonding|Normal Bonding Protocol
15985764|NCT02994836|Biological|Anti-TNF: Infliximab (Infusion)|Infliximab (Infusion 5mg/kg milligram(s)/Kilogram-Intravenous use)(Visit1,visit 3,visit 4,visit 5, visit 6 and visit 7)
15985765|NCT02994836|Drug|Anti-TNF discontinuation: Physiological saline solution|Physiological saline solution (Infusion-Intravenous use)(Visit1,visit 3,visit 4,visit 5, visit 6 and visit 7)
15985766|NCT02994836|Biological|Anti-TNF:Adalimumab (Subcutaneus)|Adalimumab (Subcutaneus 40 mg milligram(s)-subcutaneus)(Visit 1,visit 2,visit 3,visit 4,visit 5, visit 6 and visit 7).
15985767|NCT02994836|Drug|Anti-TNF discontinuation: Physiological saline solution|Physiological saline solution (Injection-subcutaneous use)(Visit 1,visit 2,visit 3,visit 4,visit 5, visit 6 and visit 7).
15985768|NCT02994810|Other|Breastfeeding guidance|Breastfeeding guidance
15985769|NCT02994784|Drug|Propylene Glycol-Free Melphalan Hydrochloride|Intravenous Propylene Glycol-Free Melphalan Hydrochloride
15985770|NCT02994771|Drug|Lymfactin® [1 x 10E10 vp]|Lymfactin® [1 x 10E10 vp] will be administered as a single dose via perinodal injection in a volume of 2 mL.
15985771|NCT02994771|Drug|Lymfactin® [1 x 10E11 vp]|Lymfactin® [1 x 10E11 vp] will be administered as a single dose via perinodal injection in a volume of 2 mL.
15985772|NCT02994758|Other|Personalised treatment|Treatment based on NGS or DSRT
15985773|NCT02994745|Drug|Fimasartan, Atorvastatin|
15985774|NCT02994732|Drug|[14C]-BVD-523|[14C]-BVD-523 administered as a 600-mg (approximately 200 µCi) oral dose to 6 healthy male subjects following a 2-hour fast from food (not including water) that follows breakfast.
15985775|NCT02994719|Drug|Anti-Parkinson medication|During the optional second visit subjects with neurological disease and already on anti-parkinson medication are asked to come off their anti-parkinson medication.
15985960|NCT02993250|Drug|AL-335|Participants will receive AL-335 800 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.
15985776|NCT02994719|Device|Deep Brain Stimulation|During the optional second visit subjects with neurological disease already treated with deep brain stimulation are asked to come temporarily stop deep brain stimulation and resume stimulation, with walking trials done in each condition.
15985777|NCT02994706|Procedure|Home Monitoring|Participants selected to receive home monitoring, in addition to routine CF care, will be given a digital lung function monitor (spirometer) and a modified mobile phone.
15985778|NCT02994706|Other|Clinical Care|Participants selected for this arm will continue to receive routine clinical care.
15985779|NCT02994693|Device|OFDI capsule imaging|Imaging of Barrett's esophagus (BE) using OFDI capsule imaging
15985780|NCT02994680|Device|Three-burner LPG stove|The intervention arm will receive a three-burner LPG stove upon enrollment. The control arm will receive the stove one year after enrollment.
15985781|NCT02994680|Other|Delivery of LPG tanks|One year supply of LPG fuel, in the form of delivery of 20 kg tank that holds 10 kg of LPG. Delivered to homes.
15985782|NCT02994680|Other|Vouchers for LPG tanks|One year supply of LPG, in the form of vouchers to obtain a free LPG tanks from a distribution center. (Beginning one year after enrollment, for one year)
15985783|NCT02994667|Device|Permanent Pacemaker Placement|
15985784|NCT02994654|Device|ReCell|"The ReCell-assigned treatment area will be treated as described in the product's Instructions for Use. In summary, 1ml of fluid physically covers a treatment area of 80 cm2. Each milliliter of fluid contains cells harvested from a square centimeter of thin split-thickness skin sample.
~The reagents and components of the ReCell kit are used, in a scalable fashion, to facilitate disaggregation of cells from skin samples into filtered cell suspension. Areas to be harvested for skin samples are to be clean and show no evidence of surrounding cellulitis or infection. Treatment area sizes and cell suspension volumes are to be recorded."
15985785|NCT02994641|Procedure|COMA Score Assessment|
15985786|NCT02994628|Other|Water|Water only without carbohydrate
15985787|NCT02994628|Other|Mini banana|Ingest mini banana containing higher phenolics and carbohydrate concentration
15985788|NCT02994628|Other|Cavendish banana|Ingest Cavendish banana (common banana)
15985789|NCT02994628|Other|6% sugar beverage|Ingest 6% sugar beverage containing same glucose and fructose profile as banana
15985790|NCT02994602|Drug|Nestorone + Testosterone Combination Gel|The combined gel is a transdermal treatment that will be applied as three single applications to a male subject's arms and shoulders on three different treatment days. The formulation will be a hydro alcoholic gel containing about 1.43% T (14.3 mg T/g gel). About 9 to 14% of the steroid (T or NES) in the gel applied is available to the body. The amount of gel to be applied each application will be approximately 5 mL in volume. The gel application volume will contain 62.5 mg of T that will deliver approximately 6 mg T to the body per day (Swerdloff et al., 2000; Wang et al., 2000). This gel volume will also contain 8.3 mg of NES that will deliver about 0.8 mg of NES to the body per day (NES 8 mg/d + T 60 mg/d (NES8/T60) gel).
15985791|NCT02994589|Other|Tegaderm™(Absorbant, 3M)|3M™ Tegaderm™ Dressing helps provide the natural moisture balance conducive to wound healing.
15985792|NCT02994589|Device|OASIS® wound matrix|OASIS® Matrix is indicated for the management of wounds including: partial- and full-thickness wounds, pressure ulcers, venous ulcers, chronic vascular ulcers, diabetic ulcers, trauma wounds (abrasions, lacerations, second-degree burns, skin tears), draining wounds, surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence).
15985793|NCT02994589|Other|Xeroform™|Xeroform™ consists of a fine-mesh gauze impregnated with bismuth tribromophenate.
15985794|NCT02994576|Drug|Atezolizumab|Atezolizumab, 1200 mg administered I.V. once
15985795|NCT02994563|Device|Thrombectomy Device|The Amnis Thrombectomy Device is intended to restore blood flow by removing thrombus from intracranial vessels in patients experiencing ischemic stroke
15985796|NCT02994550|Drug|FSH/LH|
15985797|NCT02994537|Other|Different biochemical results or pathogenesis.|Comparing the pathogenesis,clinical characteristics and treatment effects between the acute autoimmune hepatitis group and the chronic autoimmune hepatitis group. The investigators don't use special intervention.
15985798|NCT02994524|Procedure|Rerouting technique for transsphincteric perianal fistula|
15985799|NCT02994498|Drug|DCB-BO1301|1, 2, or 3 capsules, three times a day, oral, at most 48 weeks
15985800|NCT02994485|Drug|Simvastatin|Simvastatin 20 mg/day for two weeks (increased to 40 mg/day at day 15) for another two weeks plus the routine treatment
15985801|NCT02994472|Radiation|Gastric emptying scintigraphy using 99mTc-DTPA|
15985802|NCT02994459|Other|Weight Loss|Diet-induced weight loss (obese only)
15985803|NCT02994446|Device|Saline-Enhanced Radiofrequency Catheter and Ablation System|Ablation of ventricular tachycardia with a saline-enhanced radiofrequency ablation catheter
15985804|NCT02994433|Drug|Nitrous Oxide|Nitrous oxide, an odorless, colorless gas typically used as an induction agent for general anesthesia or for dental sedation, is a known N-methyl-D-aspartate (NMDA) antagonist. It will be given at 50% nitrous oxide/50% oxygen in this study.
15985805|NCT02994433|Drug|Placebo gas|Placebo gas given at 50% nitrogen [inert]/50% oxygen.
15985806|NCT02994433|Device|MRI|MRIs done on all participants, this is a tool we are using to measure outcomes. No treatment is from an MRI.
15985807|NCT02994407|Drug|turoctocog alfa pegol|"Part A: Participants will receive a single dose of turoctocog alfa pegol, administered subcutaneously (under the skin), at a dose of 12.5, 25 or 50 U/kg.
~Part B: Participants will receive a daily dose of turoctocog alfa pegol, as identified in Part A, as a subcutaneous (under the skin) injection for a period of 3 months."
15985808|NCT02994394|Drug|OPC-41061|
15985809|NCT02994381|Drug|RPC1063|
15985810|NCT02994368|Other|Observation|
15985811|NCT02994355|Other|Systems Analysis and Improvement Approach|"Understanding the cascade from FP clinic enrollment to HIV testing
~Use process mapping to identify modifiable bottlenecks
~Define and implement workflow adaptations to eliminate modifiable bottlenecks
~Monitor change in performance
~Repeat the analysis and improvement cycle (steps 1-4)"
15985812|NCT02994342|Device|Vaginal gel, Medical Device Class 2A|Application twice a day of vaginal gel for 56 consecutive days
15985813|NCT02994329|Device|OraQuick® HIV Self-Test (Orasure Technologies, Thailand)|All individuals aged 16 and above who are approached by community health workers conducting door-to door HIV testing will be offered the choice to use an oral HIV self test kit or to have standard of care finger-prick rapid HIV testing
15985814|NCT02994316|Other|Copeptine dosage in children with diabetic ketoacidosis at diagnosis|Blood collection of 3 mL for copeptin dosage will be taken at different times in the first hours of management of diabetic ketoacodosis in children under the age of 16 years
15985815|NCT02994290|Drug|HPV vaccine|After the vaccine is administered (or the patient declines the vaccine), a member of the research team (RA) will approach eligible postpartum women and invite them to participate in individual in-depth interviews.
15985816|NCT02994290|Behavioral|Inpatient Postpartum HPV Immunization Quality Improvement Program|"The program coordinator (PC) will screen electronic medical records of Women's Center patients admitted to the inpatient postpartum service for IPP-HPV eligibility: women ≤ 26 years of age who have not received all 3 doses.
~Nurses and providers in the Women's Center will be encouraged to discuss the HPV vaccine during prenatal care and recommend postpartum immunization to vaccine eligible women.
~All patients will be provided with a Vaccine Information Sheet as is required by law. A postpartum nurse will then administer the HPV vaccine as routine care prior to discharge (unless the patient refuses). A postpartum provider will be available to answer any questions or concerns as needed."
15985817|NCT02994277|Device|1° Phase: UVa algorithm 2° Phase: ITBA/UNLP algorithm|The UVa algorithm is an already established mathematical model that can be programmed in DiAs software to manage glycaemia in T1DM through a subcutaneous insulin pump and a continous glucose monitoring. This algorthm works on a meal announcement basis and will be tested during the first phase of the trial. The ITBA/UNLP algorithm is a new development with safety mechanisms improved and without need of meal anouncement. This algorithm will be tested during the second phase of the trial.
15985818|NCT02994264|Radiation|adjuvant concurrent chemoradiation|
15985819|NCT02994251|Drug|gemcitabine|1000 mg/m^2 of gemcitabine on Day 1 and 8, Dosages may be modified or delayed due to toxicities
15985820|NCT02994251|Drug|Cisplatin|25 mg/m^2 on Day 1 and 8, Dosages may be modified or delayed due to toxicities
15985821|NCT02994251|Drug|Conventional TACE (transarterial chemoembolization) with Doxorubicin/Mitomycin-C|If conventional transarterial chemoembolization (TACE) is warranted based on MRI assessment and the patient meets all the eligibility criteria for TACE therapy, then cTACE will be scheduled to take place during Week 3 of that cycle. Patients will always receive the first cTACE for study; follow-up cTACE will occur on demand.
15985822|NCT02994238|Device|Remote Health Management Sensor Platform|The Propeller sensor monitors the use of inhaled medications, capturing the date, time, and number of uses. The sensor then transmits this information using Bluetooth to a paired smart phone or hub. Data can be uploaded to the caregiver's smart phone and to the patient's web portal, which their healthcare team will have access to help overall management.
15985823|NCT02994225|Drug|Indocyanine Green|"Subcutaneous injection (1 ml) of the indocyanine green into the ipsilateral upper extremity 10 min before the surgery.
~Near Infra-red images acquisition is performed during surgery"
15985824|NCT02994212|Dietary Supplement|Monthly distribution of RUTF|115 children eligible for the outpatient treatment of SAM were provided a monthly ration of RUTF.
15985825|NCT02994199|Other|Active video gaming|Participants will engage in active video game play using two off-the-shelf (OTS) and two adapted controllers using the Wii gaming console. Controllers are: OTS balance board, OTS gaming mat, Adapted balance board, Adapted gaming mat.
15985826|NCT02994186|Procedure|Bariatric Surgery|These are patients who will be having either Vertical Sleeve Gastrectomy or Roux-en-Y Gastric Bypass.
15985827|NCT02994186|Other|Medical Weight Loss Program|These are patients who will be starting a structured medical weight loss program.
15985828|NCT02994173|Drug|Oxycodone|Current clinical practice, used as a control in this study
15985829|NCT02994173|Drug|S-Ketamine 0.25|dosage
15985830|NCT02994173|Drug|S-Ketamine 0.5|dosage
15985831|NCT02994173|Drug|S-Ketamine 0.75|dosage
15985832|NCT02994160|Other|FastLIFE electrode|Implant temporary FastLIFE electrodes and record the nerve signals that control delicate finger motions and play back the nerve signals that give the hand feelings of touch and movement.
15985833|NCT02994147|Drug|Placebo|Placebo-only control study medication is the same formulation as active treatment without active ingredient
15985834|NCT02994147|Drug|AC-201CR|The investigational product is formulated as controlled-release (CR) tablets
15985835|NCT02994134|Behavioral|Moderate intensity exercise.|Moderate intensity aerobic exercise intervention (delivered at 55-64% age-predicted maximal heart rate), 4 times per week for 4 weeks.
15985836|NCT02994134|Behavioral|High intensity exercise.|High intensity aerobic exercise intervention (delivered at 65-90% age-predicted maximal heart rate), 4 times per week for 4 weeks.
15985837|NCT02994108|Behavioral|txt2protect|Text messages sharing HIV/STI prevention information with a focus on HPV infection and vaccination.
15985838|NCT02994108|Behavioral|Sexual Health Control|Text messages sharing HIV/STI prevention and healthy relationship building information, including information about HPV infection and vaccination.
15985839|NCT02994095|Behavioral|Pilot Study|Trained community health agents used Motivational Interviewing-based counseling and action planning in monthly home visits with adults with diabetes
15985840|NCT02994082|Behavioral|Tailored behavioral intervention|Participants will receive a standard six session cognitive behavioral intervention for smokeless tobacco cessation combined with supplemental treatment modules based on individual need and preferences.
15985841|NCT02994082|Behavioral|Behavioral activation for elevated depressive symptoms|Participants with elevated depressive symptoms may receive this six session telephone-based behavioral activation intervention.
15985842|NCT02994082|Behavioral|Post-cessation weight gain management|Participants with concerns about gaining weight after quitting smokeless tobacco use may receive this six session telephone-based behavioral self-management intervention designed to help attenuate post-cessation weight gain.
15985843|NCT02994082|Behavioral|Alcohol use risk reduction|Participants engaging in risky alcohol use may receive this six session telephone-based behavioral intervention for reducing alcohol use.
15985844|NCT02994082|Drug|Nicotine replacement therapy - transdermal nicotine patch|Medication selection will be based on individual participant preferences, medical history, and contraindications.
15985845|NCT02994082|Drug|Nicotine replacement therapy - nicotine lozenge|Medication selection will be based on individual participant preferences, medical history, and contraindications.
15985961|NCT02993250|Drug|Odalasvir (ODV)|Participants will receive ODV 25 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.
15985846|NCT02994082|Drug|Nicotine replacement therapy - nicotine gum|Medication selection will be based on individual participant preferences, medical history, and contraindications.
15985847|NCT02994082|Drug|Bupropion sustained release|Medication selection will be based on individual participant preferences, medical history, and contraindications.
15985848|NCT02994082|Drug|Varenicline|Medication selection will be based on individual participant preferences, medical history, and contraindications.
15985849|NCT02994082|Drug|Combination nicotine replacement therapy|Medication selection will be based on individual participant preferences, medical history, and contraindications. Possible combinations include nicotine patch + nicotine lozenge and nicotine patch + nicotine gum.
15985850|NCT02994082|Drug|Combination nicotine replacement therapy + bupropion|Medication selection will be based on individual participant preferences, medical history, and contraindications. Possible combinations include nicotine patch + bupropion, nicotine gum + bupropion, and nicotine lozenge + bupropion.
15985851|NCT02994082|Behavioral|Tobacco quit line|Referral to the Department of Veterans Affairs tobacco telephone quit line.
15985852|NCT02994082|Behavioral|Educational materials|Information regarding the VA tobacco quit line and associated treatment services, self-help materials for tobacco cessation, and information about tobacco cessation medications available in the VA,
15985853|NCT02994069|Drug|Cisplatin|Cisplatin
15985854|NCT02994069|Radiation|XRT|Radiation Therapy
15985855|NCT02994056|Drug|SOF/VEL|400/100 mg FDC tablet administered orally once daily
15985856|NCT02994056|Drug|RBV|Tablets administered orally at 600 mg, if well tolerated then up to a maximum total daily dose of 1000 to 1200 mg (based on weight) divided twice daily.
15985857|NCT02994043|Behavioral|Mindfulness Plus Relapse Prevention Therapy|An 8-week, outpatient psychotherapy that uses cognitive-behavioral components to reduce alcohol-related consequences.
15985858|NCT02994043|Behavioral|Relapse Prevention Therapy|An 8-week, outpatient psychotherapy that combines mindfulness components with relapse prevention.
15985859|NCT02994017|Other|cardiopulmonary exercise testing|The Cardiopulmonary exercise testing (CPET) was performed at the beginning of the study, the same at each center. Each patient underwent a symptom-limited incremental exercise test on an ergometric bicycle (Ergoline-Ergometrics 800®). The protocol included a warm-up period of 3 min at 20 W followed by a progressively increasing work rate (WR) in a ramp fashion and then 3 min recovery. The ramped WR increment was individualized (range,8-30 W/min). during exercise, heart rate (HR) was monitored continuously by 12-lead ECG, and arterial oxygen saturation (SpO2) was measured by pulse oximetry (Nellcor N-395). The expired gases were analyzed with an Ergocard®, focusing on oxygen consumption(VO2), carbon dioxide production (VCO2), minute ventilation (VE), and tidal volume (VT).
15985860|NCT02994004|Other|no intervention|
15985861|NCT02993991|Drug|Mocetinostat|Mocetinostat (MGCD0103) is a potent small molecule HDAC inhibitor that targets human HDAC isoforms. It is an orally bioavailable, second generation benzamide inhibitor of HDAC 1, 2, 3 and 11 with broad spectrum antitumor activity in vitro and in vivo.
15985862|NCT02993991|Biological|Durvalumab|Durvalumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody directed against human PD-L1. It is selective for recombinant PD-L1 and blocks the binding of recombinant PD-L1 to the PD-1 and CD80 receptors.
15985863|NCT02993965|Other|Vaccine Reminder/Recall|The investigators will be sending recall notices via phone call or postcard to 11-17 year olds or 11-14 year olds who are eligible but lacking HPV vaccine doses recorded in the Colorado Immunization Information System (CIIS). The investigators will be testing the effectiveness and cost effectiveness of up to 3 notices per dose with usual care (no intervention) for bringing children 11-17 years old up to date on HPV vaccination. They will also be testing the effectiveness and cost effectiveness of using mail vs. phone call reminder notices (as compared to no intervention) for bringing 11-14 year olds up to date on HPV vaccination.
15985864|NCT02993952|Device|Transcranial Direct Current Stimulation|For electrode placement, the criteria used by the 10/20 electroencephalography system will be obeyed and the electrodes will be positioned area C3 for the anode and Fp2 (contralateral supraorbital area) for the cathode electrode. A constant current of 2mA will be applied for 20 minutes.
15985865|NCT02993952|Device|Sham Transcranial Direct Current Stimulation|For electrode placement, the criteria used by the 10/20 electroencephalography system will be obeyed and the electrodes will be positioned area C3 for the anode and Fp2 (contralateral supraorbital area) for the cathode electrode, but the stimulator was turned off after 30 seconds of stimulation. Therefore, patients in the sham group felt the initial itching sensation but received no current for the rest of the stimulation period.
15985866|NCT02993939|Procedure|Interscalene block|Ultrasound guided single shot block above the clavicle
15985867|NCT02993939|Procedure|Infraclavicular-suprascapular block|Combined block of nerves far away from phrenic nerve
15985868|NCT02993926|Drug|Enantone|Enantone suspension for injection
15985869|NCT02993926|Drug|GnRH agonist|A non-Enantone GnRH agonist
15985870|NCT02993913|Drug|Simmiparib|Simmiparib Tablets, oral administration
15985871|NCT02993900|Device|Image-Guided Brachytherapy|Brachytherapy will be precisely inserted with the assistance of magnetic resonance (MRI) scans
15985872|NCT02993887|Behavioral|Resourcefulness Training|This intervention will include a one time face to face instruction on Resourcefulness Training that entails 8 self-help and help-seeking skills plus viewing short video vignettes of caregivers describing application of the resourcefulness skills. In addition, participants will use daily journaling to describe application of the resourcefulness skills in their daily caregiving with their technology-dependent child.
15985873|NCT02993887|Behavioral|Mindfulness|The mindfulness intervention will include the use of an app daily via Stop, Think, Breathe.
15985874|NCT02993874|Dietary Supplement|Creatine|The experimental group will ingest for seven days (Loading - phase 1), 5g (4x/day) of creatine monohydrate associated with the clinical treatment (30-45 minutes of walking, 3 times a week). Subsequently, they will ingest for 49 days (Maintenance - phase 2), 3g (1x / day) creatine monohydrate associated with clinical treatment (30-45 minutes of walking, 3 times a week). They will be given guidance by telephone, so that they can reach the necessary recommendations for the study.
15985962|NCT02993250|Drug|Simeprevir (SMV)|Participants will receive SMV 75 mg once daily for 8 weeks in cohort 1 and 12 weeks in cohort 2.
15985963|NCT02993237|Drug|DRV/COBI FDC placebo tablet|Participants will receive 1 placebo tablet matching the DRV/COBI 800/150 milligram (mg) FDC
15985875|NCT02993874|Dietary Supplement|Placebo|The placebo group will ingest for seven days (Loading - phase 1), 5g (4x / day) of dextrose associated to clinical treatment (30-45 minutes of walking, 3 times per week). Subsequently, they will ingest for 49 days (Maintenance phase 2), 3g (1x / day) of dextrose associated with the clinical treatment (30-45 minutes of walking, 3 times a week). They will be given guidance by telephone, so that they can reach the necessary recommendations for the study.
15985876|NCT02993861|Other|Anti-epileptics|
15985877|NCT02993848|Other|No intervention|
15985878|NCT02993835|Other|Labeled iron salt Fe54|Fe salt enriched with Fe 54 isotopes
15985879|NCT02993835|Other|Labeled iron salt Fe57|Fe salt enriched with Fe 57 isotopes
15985880|NCT02993835|Other|Labeled iron salt Fe58|Fe salt enriched with Fe 58 isotopes
15985881|NCT02993822|Drug|Orvepitant Maleate|Tablet, once daily, oral
15985882|NCT02993822|Drug|Placebo|Tablet, once daily, oral
15985883|NCT02993809|Biological|BM-ECs and PRPE|
15985884|NCT02993809|Biological|BM-ECs|
15985885|NCT02993783|Drug|Vedolizumab|Vedolizumab IV infusion
15985886|NCT02993770|Procedure|Endoscopic DCR|Endonasal endoscopic technique as described by Wormold et al.
15985887|NCT02993770|Procedure|External DCR|External DCR
15985888|NCT02993757|Biological|CYD Dengue Vaccine|0.5 mL, SC injection at Day 0, Month 6 and 12, respectively.
15985889|NCT02993757|Biological|CYD Dengue Vaccine|0.5 mL, SC injection at Month 1, 7 and 13, respectively.
15985890|NCT02993757|Biological|Human Papillomavirus Quadrivalent [Types 6, 11, 16, and 18] Vaccine, Recombinant.|0.5 mL, IM injection at Day 0 and Month 6, respectively.
15985891|NCT02993731|Drug|Napabucasin|Napabucasin will be administered orally, twice daily, with doses separated by approximately 12 hours.
15985892|NCT02993731|Drug|Nab-paclitaxel|Nab-paclitaxel 125 mg/m^2 immediately followed by gemcitabine 1000 mg/m^2 will be administered on Days 1, 8 and 15 of every 28-day cycle via intravenous infusion.
15985893|NCT02993731|Drug|Gemcitabine|Nab-paclitaxel 125 mg/m^2 immediately followed by gemcitabine 1000 mg/m^2 will be administered on Days 1, 8 and 15 of every 28-day cycle via intravenous infusion.
15985894|NCT02993718|Drug|Dexmedetomidine|As a loading dose, 0.5 μg/kg dexmedetomidine was administered over 10 min, which was then administered continuously at a dose of 0.2-0.8 μg/kg/h. Sedation was maintained at modified observer's assessment of alertness/sedation scale 3
15985895|NCT02993718|Drug|Propofol|Propofol was infused continuously via a target-controlled infusion device, and the effect-site concentration was maintained with a range of 0.5-2.0 μg/ml. Sedation was maintained at modified observer's assessment of alertness/sedation scale 3
15985896|NCT02993705|Drug|Trabectedin|Chemotherapy drug
15985897|NCT02993692|Device|Direct laryngoscopy and fiberoptic bronchoscopy|These devices is used in endotracheal intubation and tonopen for measuring of intraoculer pressure. I want to see whcih is better.
15985898|NCT02993679|Procedure|reconstruction of the ACL and anterolateral ligament|reconstruction of the ACL and anterolateral ligament
15985899|NCT02993666|Device|Bair Hugger|forced air warming with Bair Hugger air warmer
15985900|NCT02993653|Radiation|High-dose Intensity-modulated radiotherapy|Pelvic High-dose Intensity-modulated radiotherapy with stereotactic radiotherapy or intracavitary radiotherapy
15985901|NCT02993640|Drug|vasopressin + nitro|vasopressin infusion 4,8 U/h for 20 minutes, thereafter nitroglycerine infusion to a MAP of 60 for 5 minutes.
15985902|NCT02993627|Dietary Supplement|Spirulina|2 g(4* 500 mg tablets) daily intake of Spirulina Platensis
15985903|NCT02993627|Other|diet therapy|low calorie diet (-500 or -300 kcal) composed of 55% carbohydrate, 15% protein and 30% fat
15985904|NCT02993601|Device|Heartfelt-1|The patients will stand in front of the Heartfelt-1 in order for images to be captured and the volume of their lower legs measured.
15985905|NCT02993601|Device|Weighing scales|The patient will be asked to stand on standard medical weighing scales, to measure their weight.
15985906|NCT02993601|Other|Medical grading of oedema|A member of the research team will assess the severity of the peripheral oedema on a scale of 1-5.
15985907|NCT02993601|Other|Baseline assessements|At the point study participants are recruited, their age, sex, diagnosis, aetiology of heart failure, LVEF (Left ventricular ejection fraction), medical and device therapy, time since diagnosis, BNP (B-type Natriuretic Peptide), CRP (C-Reactive Protein), renal function (EGFR), Haemoglobin, albumin and urinalysis will be assessed unless recent (less that 6 months old) results are available. The number of Heart failure hospital admissions in the last 2 years, LACE score, co-morbidities will also be noted.
15985908|NCT02993601|Device|Water displacement method|This will involve filling a gauge with lukewarm water (27-35oC +-2oC) up to the appropriate level. The appropriate level is determined by the water stabilising after some has flown out of the gauge into the waste bucket. Once the water level is stable the patient, who is sitting on a chair will be gently plunging the foot (naked) in the gauge until their foot is flat on the bottom on the gauge. The water flowing out of the gauge into the measuring bucket will be collected until the flow of water stops. Four small marks with non-toxic /non-permanent pen will be made on the lower leg of the patient to indicate where the water level was at. The water which has been collected in the measuring bucket will be weighted with precision scales to determine the volume of water displaced by the insertion of the foot. The patient's foot will then be dried.
15985909|NCT02993601|Device|Callipers measurements|This will involve making 4 marks on one of the foot/lower leg (small cross) using non-toxic / non- permanent pen. The measurement will consist of making 6 measurements between those marks using callipers, and reporting the distance on a calibrated tape.
15985910|NCT02993601|Device|Measuring tape|The measurements taken using a medical tape measure will involve the circumference of the ankle to be measured as well as the circumference at the level of the arch of the foot. The medical tape used will be a CE marked disposable medical measuring tape to minimise the risk of infection. The measurements will be done on both feet.
15985911|NCT02993588|Drug|Melatonin|Melatonin 6 mg tablet once daily
15985912|NCT02993588|Other|Placebo|one tablet once daily
15985913|NCT02993575|Drug|Flucloxacillin|Dose according to summary of product characteristics (SPC) or local protocols: intermittent and continuous infusion
15985914|NCT02993562|Drug|Levothyroxine|Normal treatment with levothyroxine.
15985915|NCT02993536|Other|Biospecimen Collection|
15985916|NCT02993523|Drug|Azacitidine|Solution for subcutaneous or intravenous administration
15985919|NCT02993510|Procedure|Microfracture|Microfracture is a well-established arthroscopic surgical technique for cartilage repair which involves several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect, with resultant complete defect fill by a well-anchored clot
15985920|NCT02993510|Device|Chondro-Gide sutured|Implantation of Chondro-Gide membrane using atraumatic sutures following microfracture via mini-arthrotomy
15985921|NCT02993510|Device|Chondro-Gide glued|Implantation of Chondro-Gide membrane using Fibrin glue following microfracture via mini-arthrotomy
15985922|NCT02993497|Device|Infrared camera|In patients undergoing spinal anesthesia, the respiratory parameters are measured using an Infrared camera.
15985923|NCT02993497|Device|RVM(Respiratory Volume Monitor)|In patients undergoing spinal anesthesia, the respiratory parameters are measured using an RVM(Respiratory Volume Monitor).
15985924|NCT02993484|Drug|Dimethyl Malonate|Heart tissue will be obtained from patients undergoing heart surgery. The tissue will be used to test the properties of ischemia and different cardioprotective interventions.
15985925|NCT02993484|Biological|Ischemic preconditioning|Heart tissue will be obtained from patients undergoing heart surgery. The tissue will be used to test the properties of ischemia and different cardioprotective interventions.
15985926|NCT02993484|Other|Ischemia reperfusion|Heart tissue will be obtained from patients undergoing heart surgery. The tissue will be used to test the properties of ischemia and different cardioprotective interventions.
15985927|NCT02993484|Other|Sham|Heart tissue will be obtained from patients undergoing heart surgery. The tissue will be used to test the properties of ischemia and different cardioprotective interventions.
15985928|NCT02993471|Drug|Drug Cocktail|Administered orally
15985929|NCT02993471|Drug|Ixekizumab|Administered SC
15985930|NCT02993458|Other|DASH diet|DASH style diet rich in fruits, vegetables, and low-fat dairy foods and low in saturated fat and total fat
15985931|NCT02993458|Other|Low Na diet|Sodium intake of 1500 mg/d (65 mmol, or 0.75 mg/Kcal/d), representing the Adequate Intake recommended by the Institute of Medicine.
15985932|NCT02993458|Other|High Na diet|Sodium intake of 3500 mg/d (152 mmol, or 1.73 mg/Kcal/d, representing the highest sodium intake used for adults in the DASH Sodium trial.
15985933|NCT02993458|Other|Usual Diet|The usual diet will include foods that provide the majority of energy for adolescents in the U.S., i.e. grain based desserts, pizza, sugary drinks,pasta, chicken, and chicken mixed dishes.
15985934|NCT02993445|Other|Alternate Nostril Breathing|
15985935|NCT02993445|Device|Foot Reflexology|
15985936|NCT02993432|Device|Foley catheter filled to 80cc|A Foley catheter is inserted through the cervix and filled to 80cc
15985937|NCT02993432|Drug|prostaglandin of the clinician's choice|Insertion of the prostaglandin (Prostin (1mg dinoprostone vaginal gel) or Cervidil (10mg vaginal slow release insert)) of the clinicians choice into the vagina for the purpose of cervical ripening
15985938|NCT02993419|Drug|Bacillus licheniformis Intervention|On the basis of the use of antibiotics in children with symptomatic treatment, the addition of experimental drugs 1 bag each time, three times a day, for taking seven days; children observed during the test is no longer taking other probiotic preparations, and any other proprietary Chinese medicine preparation
15985939|NCT02993419|Other|placebo Intervention|On the basis of the use of antibiotics in children with symptomatic treatment, the addition of placebo drugs 1 bag each time, three times a day, for taking seven days; children observed during the test is no longer taking other probiotic preparations, and any other proprietary Chinese medicine preparation
15985940|NCT02993406|Drug|Bempedoic acid 180 mg tablet|Patients take bempedoic acid 180 mg tablet orally once daily
15985941|NCT02993406|Drug|Matching placebo tablet|Patients take matching placebo tablet orally once daily
15985942|NCT02993393|Other|Teacher|The teachers' questionnaire based on table of specification of the learning contents, consisted of 4 parts: airway evaluation, patient preparation, strategic planning and follow up care.
15985943|NCT02993393|Other|Student|The students' questionnaire comprised 3 parts: learning content, process and evaluation.
15985944|NCT02993380|Dietary Supplement|Stir-fried olive oil group|Stir-fried olive oil group taking food with extra-virgin olive oil in stir fried food or any food with olive oil in heated under 150 degrees of celsius minimal dose per week is 30gram, providing amount of olive oil with meals is 10gram, three times in a weeks
15985945|NCT02993380|Dietary Supplement|Natural olive oil group|Natural olive oil group taking food with extra-virgin any food with olive oil in , minimal dose per week is 30grams, providing amount of olive oil with meals is 10gram, three times in a weeks
15985946|NCT02993367|Drug|Butylphthalide Soft Capsules|DL-3-n-butylphthalide (NBP) (Fig. 1) is a synthetic chiral compound containing L- and D-isomers of butylphthalide.Butylphthalide Soft Capsules is the oral preparation.
15985947|NCT02993367|Drug|Placebo Butylphthalide Soft Capsules|
15985948|NCT02993354|Device|The EUM300 (electrical uterine myography)|External monitor intended for the evaluation of electrical signals originating in the uterus, thus providing a tool for measuring uterine activity as well as fetal heart rate.
15985949|NCT02993341|Drug|Tranexamic Acid|
15985950|NCT02993341|Other|Saline Wash|
15985951|NCT02993328|Drug|SAN021 Serum|SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.
15985952|NCT02993328|Drug|SAN021 Placebo|SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.
15985953|NCT02993315|Biological|nDC vaccination|
15985954|NCT02993315|Biological|placebo injection|
15985955|NCT02993302|Drug|1α-D3|patients were given PTU and 1α-D3
15985956|NCT02993302|Drug|Placebos|patients were given PTU and placebos
15985957|NCT02993289|Other|Different well-known treatments|
15985958|NCT02993276|Device|Neurocap®|NEUROCAP®, a bioresorbable nerve capping device based upon the NEUROLAC® nerve guide, is indicated to protect a peripheral nerve end and to separate the nerve from surrounding environment to reduce the development of a symptomatic neuroma.
15985959|NCT02993263|Device|VectraplexECG System with CEB®|The device will be used after noncardiac surgery
15985964|NCT02993237|Drug|D/C/F/TAF FDC placebo tablets|Participants will receive 1 placebo tablet matching the D/C/F/TAF 800/150/200/10 mg FDC.
15985965|NCT02993224|Drug|Deferasirox dispersable tablet (DT)|"Deferasirox DT was provided as 125 mg, 250 mg, 500 mg dispersible tablets for oral use. The strengths provided in an individual country could differ and reflected the strengths available commercially in each country.
~For iron chelation naive participants, the starting dose on Baseline Day 1 was 20 mg/kg/day in TDT and 10 mg/kg/day in NTDT.
~For iron chelation (deferoxamine and/or deferiprone) pre-treated participants, the starting dose was equivalent to the dose of deferoxamine received (for participants pre-treated with deferoxamine) and based on their serum ferritin levels (for participants pre-treated with deferiprone).
~Participants took deferasirox DT once daily for 24 weeks (core phase). The required number of deferasirox DT tablets were to be dispersed with gentle stirring in a glass of water."
15985966|NCT02993224|Drug|Deferasirox film coated tablet (FCT)|"Deferasirox FCT was provided as 90 mg, 180 mg, 360 mg film coated tablets for oral use. The FCT starting dose on Week 25 was 14 mg/kg/day in TDT and 7 mg/kg/day in NTDT.
~Participants took deferasirox FCT once daily for 24 weeks during the core phase and up to 48 weeks during the extension phase. For patients with difficulties in swallowing deferasirox FCT, it was allowed to crush the film-coated tablets and administer the study drug by sprinkling the full dose on soft food (like yogurt or apple puree)."
15985967|NCT02993211|Device|Bipolar transurethral standard resection|Olympus TURis Bipolar HF-resection electrode (Model: WA22306D)
15985968|NCT02993211|Device|Bipolar transurethral en bloc resection|Olympus TURis Bipolar HF-resection electrode (Model: WA22306D)
15985969|NCT02993198|Drug|Carvedilol|
15985970|NCT02993185|Behavioral|Your Move|"Your Move (YM) is an interactive sex education intervention. Groups of girls are randomly assigned to YM or Eat Smart (ES), a control interactive nutrition education intervention. Each program consist of seven 75-minute sessions, and each session contains 60 minutes of facilitator-led discussion, video clips, activities, and games as well as 15 minutes of personal reflection time during which girls practice the decision making skills they have learned. Participants complete online surveys about their attitudes, knowledge, and behavior related to food and nutrition and relationships and sex at baseline and also 3 months after the program ends."
15985971|NCT02993185|Behavioral|Eat Smart|"Eat Smart (ES) is an interactive nutrition education intervention. Groups of girls are randomly assigned to ES or Your Move, an interactive sex education intervention. Each program consist of seven 75-minute sessions, and each session contains 60 minutes of facilitator-led discussion, video clips, activities, and games as well as 15 minutes of personal reflection time during which girls practice the decision making skills they have learned. Participants complete online surveys about their attitudes, knowledge, and behavior related to food and nutrition and relationships and sex at baseline and also 3 months after the program ends."
15985972|NCT02993159|Drug|Afimoxifene|Applied to the breast
15985973|NCT02993159|Other|Laboratory Biomarker Analysis|Correlative studies
15985974|NCT02993159|Other|Placebo|Given PO
15985975|NCT02993159|Other|Placebo|Applied to the breast
15985976|NCT02993159|Drug|Tamoxifen Citrate|Given PO
15985982|NCT02993133|Drug|Cellcept® in autoimmune bullous dermatoses|The administration will follow the recommendations for the use of Cellcept® in autoimmune bullous dermatoses
15985983|NCT02993107|Biological|AR101|AR101 powder provided in capsules & sachets
15985984|NCT02993094|Drug|Ixazomib|Cycles will be repeated every four weeks. All subjects will continue on study drug until disease progression, unacceptable toxicity or treatment discontinuation for any other reason.
15985985|NCT02993094|Drug|Carboplatin|Cycles will be repeated every four weeks. Cycles will be repeated every four weeks. All subjects will continue on study drug until disease progression, unacceptable toxicity or treatment discontinuation for any other reason.
15985986|NCT02993068|Other|Educational Intervention|Watch genetic testing online educational video
15985987|NCT02993068|Other|Genetic Counseling|Receive post-telephone genetic counseling
15985988|NCT02993068|Other|Genetic Counseling|Receive pre-telephone genetic counseling
15985989|NCT02993068|Other|Laboratory Biomarker Analysis|Correlative studies
15985990|NCT02993068|Other|Questionnaire Administration|Ancillary studies
15985991|NCT02993055|Drug|Ulimorelin|
15985992|NCT02993055|Other|Placebo|
15985993|NCT02993042|Device|Robot-assisted gait training|Patients should use their belts (Harness) to support their weight when walking in equipment. In the first training session, the patient focuses on fitting and adapting the equipment and helps the patient learn. To minimize skin damage, the patient can wear a protector. The initial walking speed starts at 1.5km / h (0.42m / s) and can be increased gradually to 3.0km / h (0.83m / s) by increasing to 0.2km / h (0.06m / s) per session. The therapist provides appropriate visual and auditory instructions to allow the patient to participate as fully as possible in the walking cycle provided by the walking robot. The treatment time per session is 30 minutes except for the time of wearing and releasing.
15985994|NCT02993029|Drug|99Tc-MDP|99Tc-MDP 15mg in 100ml normal saline intravenously dripped every twice a week for 5 weeks, every 1weeks for 10 weeks, every 2weeks for 10 weeks, every 1 month for 6 months.
15985995|NCT02993029|Drug|Celecoxib|Celecoxib capsule 200mg qd by mouth.
15985996|NCT02993016|Procedure|patient-specific instruments|
15985997|NCT02993016|Device|The Signature™ Vanguard|
15985998|NCT02993016|Procedure|conventional instruments|
15985999|NCT02993016|Device|Vanguard PS(posterior stabilized)|
15986000|NCT02993003|Device|Nasopharyngeal probe|nasopharyngeal probe insertion
15986001|NCT02992990|Procedure|Bladder tumor biopsy|Bladder tumor biopsy performed at the time of the preoperative office flexible cystoscopic evaluation.
15986002|NCT02992977|Biological|AutoSynVax™ vaccine|AutoSynVax™ vaccine + QS-21 Stimulon® adjuvant
15986003|NCT02992964|Drug|Nivolumab|Nivolumab (also referred to as BMS-936558 or MDX1106) is a human monoclonal antibody (HuMAb; immunoglobulin G4 [IgG4]-S228P) that targets the programmed death-1 (PD-1) cluster of differentiation 279 (CD279) cell surface membrane receptor.
15986004|NCT02992951|Device|DACC-Coated Post Operative Dressing|Leukomed Sorbact is a non-active coated wound dressing, containing Dialkylcarbomoylchloride. This is a bacteria-binding compound that adheres bacteria via hydrophobic interaction and removes them from the wound bed at dressing change.
15986005|NCT02992938|Drug|Acetazolamide|
15986006|NCT02992938|Drug|Placebo Oral Tablet|
15986007|NCT02992925|Biological|DPT-IPV-Hib-High（Combined Vaccine）|
15986008|NCT02992925|Biological|DPT-IPV-Hib-Low（Combined Vaccine）|
15986009|NCT02992925|Biological|Hib vaccine|
15986010|NCT02992925|Biological|DPT-IPV|
15986011|NCT02992912|Drug|Anti-PD-L1 antibody atezolizumab|1200 mg every 3 weeks
15986012|NCT02992912|Procedure|SABR|Hypofractionated SABR will be delivered at a dose of 45 Gy in 3 fractions of 15 Gy
15986013|NCT02992899|Device|GammaCore/electroCore non-invasive VNS device|Vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The intensity of the stimulus (the current amplitude) is adjusted by the user, to the maximum tolerable level to ensure VNS without causing excessive pain (typically 10-30 V), the burst frequency to 5 kilohertz (kHz), and the envelope frequency to 25 Hz. These are the standard frequency settings that electroCore has demonstrated to be most effective in capturing the vagus nerve based on evoked potential studies. The duration of delivery is 2 minutes, one minute into which the high-resolution positron emission tomography (HR-PET) scan is conducted; following an additional 8 minutes, a second VNS delivery is administered, after which another scan is obtained.
15986014|NCT02992899|Device|Sham gammaCore/electroCore|Sham vasal nerve stimulation (VNS) is self-administered using the electroCore non-invasive VNS device. The device is programmed such that no actual stimulation is given to the vagus nerve. The duration of delivery is 2 minutes, one minute into which the HR-PET scan is conducted; following an additional 8 minutes, a second sham VNS delivery is administered, after which another scan is obtained.
15986015|NCT02992899|Drug|O-15 water|Oxygen-15 labelled water is a radioactive variation of regular water, in which the oxygen atom has been replaced by oxygen-15 (15O), a positron-emitting isotope. 15O-water is used as a radioactive tracer for measuring and quantifying blood flow using positron emission tomography (PET) . H2[15O] will be prepared on-site in the Emory PET Center cyclotron. During the hours of the test, an intravenous infusion of normal saline will be started to permit the bolus injection of H2[15O]. Subjects will receive a 20 mCi intravenous bolus of H2[15O] for each of the 14 scans during exposure to neutral and traumatic scripts.
15986016|NCT02992886|Radiation|Preoperative radiation|Radiation treatment before surgery
15986017|NCT02992886|Drug|Raltitrexed|concurrent chemotherapy
15986018|NCT02992886|Procedure|Pelvic surgery|
15986019|NCT02992873|Device|Layperson allocated to start CPR and fetch nearest AED|Dispatching laypersons to fetch an AED and start CPR in out-of-hospital cardiac arrest
15986020|NCT02992873|Device|Layperson allocated to start CPR|Dispatching laypersons to start CPR out-of-hospital cardiac arrest
15986021|NCT02992860|Drug|JNJ-56022473|JNJ-56022473 will be supplied as a lyophilized product containing 100mg of active pharmaceutical ingredient (50 mg/mL after reconstitution with 2.0 mL sterile water for injection). The JNJ-56022473 dose administered will be dependent upon the subject's weight at baseline. The JNJ-56022473 dose should be adjusted in case the subject's weight changes by > 10%. JNJ- 56022473 will be administered in 250 mL IV infusion over approximately 180 minutes using an infusion pump.
15986022|NCT02992860|Procedure|Bone marrow analyses and CBC with differential|Bone marrow analyses and CBC with differential will be performed by a central laboratory. If the marrow cannot be aspirated, a biopsy should be performed.
15986023|NCT02992860|Other|Flow cytometry analyses|Characterization of LSCs and blasts (including CD123 and CD38 expression) will be performed as study-related analyses in the context of this protocol by central flow cytometry using bone marrow samples.
15986024|NCT02992860|Other|Central biobanking|Central biobanking of study samples (bone marrow, peripheral blood as well as a buccal swab) will be carried out in Dresden.
15986025|NCT02992860|Procedure|Histopathology analysis|A bone marrow biopsy is taken whenever it seems necessary to the investigator.
15986026|NCT02992860|Genetic|Cytogenetic analysis|The cytogenetic analysis with banding analysis (optional FISH) have to be performed at local labs. Therefore 2 - 5 ml of bone marrow will be collected and analysed.
15986027|NCT02992860|Procedure|Serum chemistry|For serum chemistry 15 ml (2 x 7,5 ml) of peripheral blood have to be collected.
15986028|NCT02992860|Procedure|Automated CBC|For CBC a minimum of 3 ml of peripheral blood have to be collected.
15986029|NCT02992860|Procedure|Pregnancy Test|Serum or urine pregnancy testing β-HCG with a sensitivity of at least 25 mIU/mL is to be done not more than 3 days prior to initiation of JNJ-56022473 in female patients with childbearing potential. Furthermore, serum or urine pregnancy testing has to be done after end of treatment (EoT) visit.
15986030|NCT02992847|Other|Unenhanced MRI|
15986031|NCT02992834|Biological|IL-2 pre-treated CD19 cells|IL-2 stimulated, CD28-ζ-vector transfected T cells(TCRζ chimeric antigen receptor-T cell)， were administered at 1×106/kg by single infusion
15986032|NCT02992834|Biological|IL-7/IL-15 pre-treated CD19 cells|IL-7/IL-15 stimulated, CD28-ζ-vector transfected T cells(TCRζ chimeric antigen receptor-T cell)， were administered at 1×106/kg by single infusion
15986033|NCT02992821|Procedure|Bed-side pocket size ultrasound imaging|
15986034|NCT02992821|Procedure|High frame rate tracking doppler|
15986035|NCT02992808|Drug|recombinant gonadotropins|
15986036|NCT02992808|Drug|HP-HMG|
15986037|NCT02992795|Device|BrainPulse|JanMedical's BrainPulse measures the brain motion caused by pulsatile blood flow from the cardiac cycle referred to as the BrainPulse signal. The BrainPulse measures skull acceleration in response to tge brain motion using an array of sensors placed on the head.
15986038|NCT02992782|Behavioral|Standard Care|Home program of decongestive exercise and daily use of a compression sleeve
15986039|NCT02992782|Behavioral|Exercise and Compression Garment|Decongestive progressive resistance exercise using flat-knit garment and daily use of a compression sleeve
15986040|NCT02992782|Behavioral|Exercise and Adjustable Compression Wrap|Decongestive progressive resistance exercise using adjustable compression wrap and daily use of a compression sleeve
15986041|NCT02992756|Drug|Growth Factors|one dose 3-6 mL of PRP obtained by PRGF Endoret
15986045|NCT02992730|Behavioral|No Intervention|No Intervention
15986046|NCT02992704|Drug|Peginterferon Alfa-2A|peginterferon alpha 2a 180mcg weekly for either 24 or 48 weeks
15986047|NCT02992691|Drug|20% w/w sodium bicarbonate|Dentifrice containing 20% w/w sodium bicarbonate.
15986048|NCT02992691|Drug|35% w/w sodium bicarbonate|Dentifrice containing 35% w/w sodium bicarbonate.
15986049|NCT02992691|Drug|50% w/w sodium bicarbonate|Dentifrice containing 20% w/w sodium bicarbonate.
15986050|NCT02992691|Drug|67% w/w sodium bicarbonate|Dentifrice containing 67% w/w sodium bicarbonate.
15986051|NCT02992691|Drug|0% w/w sodium bicarbonate|Dentifrice containing 0% sodium bicarbonate and 1450 parts per million (ppm) fluoride.
15986052|NCT02992678|Drug|Pentoxifylline|Pentoxifylline, 400 mg, 3 times daily by mouth the day before ERCP procedure. Subjects received up to a maximum of 3 doses.
15986053|NCT02992678|Drug|Placebo|Placebo, 400 mg, 3 times daily by mouth by mouth the day before ERCP procedure. . Subjects received up to a maximum of 3 doses.
15986054|NCT02992665|Drug|Ca Ionophore A23187|Sibling oocytes are to be randomized to artificially activated using Calcium ionophore in cases with severely compromized semen parameters
15986055|NCT02992665|Other|Placebo|Placebo is used to control Ca ionophore group
15986056|NCT02992652|Drug|Allopurinol|600 mg of allopurinol divided in two oral doses before the procedure (300 mg at 15 hours and 300 mg at 3 hours before ERCP)
15986057|NCT02992639|Behavioral|Control group|The participants who included in control group did not receive any treatment.
15986058|NCT02992639|Behavioral|Weight loss group|The participants who included in weight loss group followed a 12-week weight loss program consisting of a 300 kcal/day reduction of thier usual caloric intakes
15986059|NCT02992626|Other|Human-dog interaction|The tests are completed in the presence of a dog. Further, before starting the tests, the children have 15 minutes to interact with the present dog.
15986060|NCT02992626|Other|Stuffed toy dog|The tests are completed in the presence of a stuffed toy dog. Further, before starting the tests, the children have 15 minutes to play with the stuffed toy dog.
15986061|NCT02992613|Procedure|total knee arthroplasty with ultra-congruent (UC) insert|
15986062|NCT02992613|Procedure|total knee arthroplasty with posterior-stabilized (PS) insert|
15986063|NCT02992587|Other|CAF, Comprehensive assessment of frailty|CAF, Comprehensive assessment of frailty. A scoring system of the patients physical status. By smaller physical test of balance, strength and walking speed.
15986064|NCT02992574|Radiation|Post Mastectomy Radiation therapy|Post mastectomy radiotherapy to the chest wall and ipsilateral supra-clavicular fossa to a dose of 40 Gy in 15 fractions over 3 weeks
15986065|NCT02992561|Behavioral|FORNET (adapted version)|
15986066|NCT02992548|Drug|Pravastatin|
15986067|NCT02992535|Device|Intense Pulse Light Energy delivery (IPL)|
15986068|NCT02992522|Drug|Lenalidomide|Given PO
15986069|NCT02992522|Biological|Obinutuzumab|Given IV
15986070|NCT02992522|Drug|Venetoclax|Given PO
15986071|NCT02992509|Device|EMED detruset(TM) intravesical electrical stimulation|"There will be a total of 8 therapy sessions, each lasting 15 minutes. The sessions will be done in a serial fashion, 2 per week for 4 consecutive weeks. The electrical parameters utilized will be those previously determined to be appropriate for OAB and UUI. As the beneficial effect of electrical stimulation is dependent on a maximal level of stimulation, the stimulation voltage will be increased during the first minute of treatment until the maximum tolerated by the patient is established and then backed-off by 1-2 Volts. The therapy will continue for 15 minutes in total for each session. The VAS will be marked by the patient before each treatment session throughout the therapy period, and other questionnaires will be administered."
15986072|NCT02992496|Drug|Ketamine|1mg/kg, 6 applications over 2 weeks
15986073|NCT02992496|Drug|Midazolam Hydrochloride|0.03mg/kg, 6 applications over 2 weeks
15986074|NCT02992483|Drug|MIK665|MIK665
15986075|NCT02992470|Dietary Supplement|Hydrolyzed oyster extract|1 tablet of oyster extract t.i.d. for 8 weeks
15986076|NCT02992470|Dietary Supplement|Placebo|1 tablet of maltodextrin t.i.d. for 8 weeks
15986077|NCT02992457|Drug|Sofosbuvir|Sofosbuvir 400 mg daily.
15986078|NCT02992457|Drug|Ribavirin|Ribavirin 1000-1200 mg daily
15986079|NCT02992457|Drug|Pegylated-interferon alfa-2a|Pegylated interferon alfa-2a once weekly for 3 months
15986080|NCT02992457|Drug|Simeprevir|Olysio once daily.
15986081|NCT02992457|Drug|Daclatasvir|Dakla once daily for three months.
15986082|NCT02992457|Drug|Ritaprevir, paritaprevir, ombetasvir|Querevo for three months
15986083|NCT02992457|Drug|Sofosbuvir and Ledipasvir|Once daily for three months
15986084|NCT02992457|Drug|Salvage therapy|three months in repeated treatment failure
15986085|NCT02992444|Other|Standard adhesive strip|This is a standard adhesive strip (hydrocolloid)
15986086|NCT02992444|Other|Experimental adhesive strip|This is a strip of a newly developed adhesive.
15986087|NCT02992431|Behavioral|Participatory patient care planning|Intervention includes the patient activation questionnaire form, a visit to the nurse who conducts the measurements (blood pressure, waist measurement, weight and length) and a visit to the general practitioner who discusses and agrees with the patient about the treatment goals and follow-up resulting in the written PPCP.
15986088|NCT02992431|Other|Usual care|Usual care including standard disease specific follow-up with visit to general practitioner.
15986089|NCT02992418|Biological|CYD Dengue Vaccine|0.5 milliliter (mL), Subcutaneous at Month 1, 7 and Month 13, respectively
15986090|NCT02992418|Biological|Tdap: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine adsorbed|0.5 mL, intramuscularly (IM) at Month 1.
15986091|NCT02992418|Biological|Tdap: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed|0.5 mL, intramuscularly at Day 0.
15986092|NCT02992405|Behavioral|FOCUS Resilience Enhancement Program|Each couple or family will have 10 weekly 75 minute sessions comprising the treatment protocol.Questionnaires will be administered at baseline-before the immediate treatment phase (T1) and after the 10-week treatment is completed (T2).
15986196|NCT02991677|Behavioral|aerobic exercise intervention|Exercise physiologist supervised walking or running on the treadmill 3 times weekly for 12 weeks.
15986093|NCT02992405|Behavioral|Waitlist (No Study Treatment)|Participants assigned to the Waitlist (No Treatment) group will receive the study intervention only after the 10 weeks of the immediate treatment phase has been completed. Questionnaires will be administered at baseline-before the immediate treatment phase (T1) and after the immediate treatment phase is completed (T2).
15986094|NCT02992392|Drug|Liposic|one eye of the participant recieved Lipoic
15986095|NCT02992392|Drug|Tears Naturale Forte|the other eye of the participant recieved Tears Naturale Forte
15986096|NCT02992379|Device|pivot splint|A 2-mm-thick, hard, clear sheet of resin will be adapted to the maxillary arch . Small amount of selfcuring acrylic will be added to the anterior portion of the appliance as a stop for the lower incisor. The area of this stop is approximately 4 to 6 mm. The patient is instructed to protrude the mandible slightly and to open and close the mouth In this position. Self-curing acrylic will be added to the occluding surface of the appliance. All occluding areas, except the contact on the anterior stop . Excess acrylic surrounding the centric contacts is removed with a hard rubber wheel on a lathe.
15986097|NCT02992379|Device|stabilizing splint|A 2-mm-thick, hard, clear sheet of resin will be adapted to the maxillary arch . Small amount of self-curing acrylic will be added to the anterior portion of the appliance as a stop for the lower incisor. The area of this stop is approximately 4 to 6 mm. The patient is instructed to protrude the mandible slightly and to open and close the mouth In this position. Self-curing acrylic will be added to the occluding surface of the appliance. All occluding areas, except the contact on the anterior stop . Excess acrylic surrounding the centric contacts is removed with a hard rubber wheel on a lathe. intervention: pivot splint
15986098|NCT02992366|Procedure|implant placement|implant placement
15986099|NCT02992353|Procedure|Three-port pulmonary resection surgery|Three-port pulmonary resection surgery
15986100|NCT02992353|Procedure|Single-port or two-port surgery|Single-port or two-port pulmonary resection surgery
15986101|NCT02992340|Drug|Varlitinib|Per oral (PO) Varlitinib BID (starting dose at 200 mg BID)
15986102|NCT02992340|Drug|Cisplatin|On D1 and D8, every 3 weeks. Cisplatin (25 mg per square meter of body surface area) in 1 litre of 0.9% saline with 20 mmol of potassium chloride and 8 mmol of magnesium sulfate intravenous (IV) infusion for 2 hours, followed by 500 mL of 0.9% saline over 30 minutes before the administration of Gemcitabine
15986103|NCT02992340|Drug|Gemcitabine|On D1 and D8, every 3 weeks. Gemcitabine (1000 mg per square meter of body surface area) as a 30-minute infusion.
15986104|NCT02992314|Device|Metaqil™ Oral Rinse|Metaqil™ is a proprietary formulation of GRAS ingradients
15986105|NCT02992314|Device|Placebo|Placebo formulation with out the active ingredients
15986106|NCT02992301|Drug|Alirocumab|Injectable prescription medicine called a PCSK9 inhibitor.
15986107|NCT02992288|Drug|Neladenoson bialanate (BAY1067197)|5 mg orally once daily for 20 weeks
15986108|NCT02992288|Drug|Neladenoson bialanate (BAY1067197)|10 mg orally once daily for 20 weeks
15986109|NCT02992288|Drug|Neladenoson bialanate (BAY1067197)|20 mg orally once daily for 20 weeks
15986110|NCT02992288|Drug|Neladenoson bialanate (BAY1067197)|30 mg orally once daily for 20 weeks
15986111|NCT02992288|Drug|Neladenoson bialanate (BAY1067197)|40 mg orally once daily for 20 weeks
15986112|NCT02992288|Drug|Placebo|Orally once daily for 20 weeks
15986113|NCT02992275|Other|Neuromuscular electrical stimulation (NMES)|Participants will receive NMES to the hip abductors while performing strength training 3 times per week for 24 weeks
15986114|NCT02992275|Other|Multi-Modality Balance Intervention (MMBI)|Participants will attend a group balance class that focuses on movement and obstacle negotiation 3 times per week for 24 weeks
15986115|NCT02992262|Device|Point of care ocular ultrasound|
15986116|NCT02992236|Drug|VAS203|Infusion of NO-Synthase inhibitor VAS203
15986117|NCT02992236|Drug|Saline|Infusion of saline
15986118|NCT02992210|Genetic|4SCAR-GD2|
15986119|NCT02992197|Biological|Rotarix, dose 1|Rotarix, dose 1
15986120|NCT02992197|Biological|Rotarix, dose 2|Rotarix, dose 2
15986121|NCT02992197|Drug|Placebo (for Rotarix dose 2)|Sterile water to provide volume equivalent as a second dose of Rotarix
15986122|NCT02992184|Device|HCV RNA detection with Genedrive assay|
15986123|NCT02992184|Device|HCV RNA detection with RealTime HCV|
15986124|NCT02992171|Behavioral|care management by oncology nurses|The intervention employs a care management approach to facilitate provision of primary palliative care within existing oncology clinic structures. The intervention is deployed through a series of nurse-led encounters occurring before or after regularly-scheduled oncology clinic visits.
15986125|NCT02992158|Behavioral|behavioral activation|
15986126|NCT02992158|Behavioral|treatment-as-usual|psychotherapy (and potentially medication) as part of treatment-as-usual provided in a community mental health center
15986127|NCT02992132|Drug|Pimavanserin 34 mg|Pimavanserin 34 mg, tablet, taken as two 17 mg tablets, once daily by mouth
15986128|NCT02992132|Drug|Pimavanserin 20 mg|Pimavanserin 20 mg, tablet, taken as two 10 mg tablets, once daily by mouth
15986129|NCT02992132|Other|Placebo|Placebo, taken as two tablets, once daily by mouth
15986130|NCT02992119|Biological|RTS,S/AS01B Fractional dose|RTS,S/AS01B standard dose at Month 0 and Month 1 + RTS,S/AS01B fractional dose (1/5th dose) at Month 2.
15986131|NCT02992119|Biological|Double RTS,S/AS01E Fractional dose|A double dose of RTS,S/AS01E standard dose at Month 0 and Month 1 + a double dose of RTS,S/AS01E fractional dose (1/5th dose) at Month 2.
15986132|NCT02992119|Biological|RTS,S/AS01E Standard dose|RTS,S/AS01E standard dose at Month 0, Month 1 and Month 2.
15986133|NCT02992119|Biological|RTS,S/AS01E + DHA-PIP+PQ Standard dose|RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0, Month 1 and Month 2
15986134|NCT02992119|Biological|RTS,S/AS01E Fractional dose|RTS,S/AS01E standard dose at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) at Month 2.
15986135|NCT02992119|Biological|RTS,S/AS01E + DHA-PIP+PQ Fractional dose|RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 and Month 1 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2.
15986136|NCT02992119|Biological|RTS,S/AS01E + DHA-PIP+PQ Fractional two-dose|RTS,S/AS01E standard dose + DHA-PIP+PQ at Month 0 + RTS,S/AS01E fractional dose (1/5th dose) + DHA-PIP+PQ at Month 2
15986197|NCT02991677|Other|control group|weekly contact by study staff with survivorship information offered not related to neuropathy.
15986137|NCT02992106|Other|Parental questionnaires|"We will provide parents with questionnaires depending on the age of their children:
~Children aged 0-6 years old:
~Questionnaire on socio-demographic characteristics
~Dutch Eating Behaviour Questionnaire
~Food Frequency Questionnaire
~Ages and Stages Questionnaire
~Strengths and Difficulties Questionnaire
~Questionnaire on developmental milestones
~Questionnaire on behaviour
~Children older than 6 years:
~Questionnaire on socio-demographic characteristics
~Dutch Eating Behaviour Questionnaire
~Food Frequency Questionnaire
~Pediatric Quality of Life Questionnaire
~Children's Behaviour Questionnaire in Dutch
~Questionnaire on developmental milestones
~Developmental Coordination Disorder Questionnaire
~Strengths and Difficulties Questionnaire"
15986138|NCT02992106|Other|Blood sample|We will determine the following biochemical parameters: glucose, insulin, total cholesterol, LDL, HDL, triglycerides, uric acid, IGF-1, adiponectin, leptin, hs-CRP, IL-6, TNF-α and ICAM-1.
15986139|NCT02992106|Other|Urine sample|We will take a urine sample to evaluate the albumin to creatinin ratio.
15986140|NCT02992106|Other|Anthropometric measurements|We will measure weight, Height, hip, waist and neck circumference, blood pressure, 4-site skinfold measurements and BIA.
15986141|NCT02992106|Other|Ultrasound|We will do an abdominal ultrasound to measure the abdominal fat accumulation
15986142|NCT02992106|Other|EndoPAT|We will use the EndoPAT device to measure endothelial function, which is a non-invasive and innovative technique (peripheral pulse wave amplitude measurement).
15986143|NCT02992106|Other|Faces Pain Scale|After performing the measurements with the EndoPAT device, Harpender kalliper and ultrasound, the children will be asked to fill out a Faces Pain Scale, validated for children aged 4-16 years old and obtained for use from the International Association for the Study of Pain
15986144|NCT02992093|Other|all the indicators|BMI、WHR、FSH、LH、PRL、T、E2、TG、CHOL、LDL-C、HDL-C、FBG、OGTT、FINS、insulin release test、HOMA index、identification of metabolites
15986145|NCT02992080|Other|miRNAs isolation from blood samples of patients and control|Blood sample collection in specific PAXGene tubes
15986146|NCT02992054|Other|stimulating activities|
15986147|NCT02992041|Drug|VVZ-149 Injections|IV infusion of 900 or 1100 mg of VVZ-149
15986148|NCT02992041|Drug|Placebo|IV infusion of 0 mg of VVZ-149
15986149|NCT02992028|Drug|Intravenous Nutrition (Vitamins) injection|
15986150|NCT02992028|Drug|Intravenous Saline injection|
15986151|NCT02992015|Drug|Gemcitabine|Participants receive a one time IV dose of gemcitabine prior to having standard of care surgery.
15986152|NCT02992002|Other|Fluid Challenge|Infusion of a standardized amount of crystalloid solution (500 ml) to assess fluid responsiveness by means of changes in cardiac output, assessed by transpulmonary thermodilution.
15986153|NCT02991989|Behavioral|Exercise Snacking|"Each bout of exercise snacking consists of 5 exercise. Each exercise is performed for one minute, with aim of completing as many repetitions as possible of that exercise in that minute. One minute of rest is observed between each exercise of the exercise snack. The five exercises are; sit-to-stand from a chair, marching on the spot, seated knee extensions alternating legs, standing knee bends alternating legs, and standing calf raises. The sit-to-stand exercise is always performed first, with the number of repetitions achieved recorded, and subsequent exercises performed in any order without recording of repetitions.
~Two exercise snacks are completed each day for 28 days; once in the morning and once in the evening, or at least separated by 2 hours."
15986154|NCT02991989|Dietary Supplement|Yogurt|Participants are asked to consume 150 g of yogurt (Arla, Skyr- natural flavour) with their breakfast meal. Participants may substitute the yogurt for another part of their regular breakfast, or add the yogurt to their regular breakfast, with participants asked to record a log book of daily yogurt consumption and to complete a three day food diary during the last week of the 28 day intervention period.
15986155|NCT02991976|Procedure|Oxygen concentration|Shunting, raising concentration of O2 because of improving regional cerebral oxygen saturation (rSO2), keeping blood pressure above 120-130 mmHg, positive end expiratory pressure (PEEP)
15986156|NCT02991963|Other|Interview|A survey will be included patient demographics, information on malaria treatment, bed net use and possible risk factors for acquiring malaria, as well as questions about their travel and usage of mobile phones
15986157|NCT02991963|Other|Blood collection (Dried Blood Spot)|Dried Blood Spot
15986158|NCT02991963|Other|Blood Collection (Venous Blood collection)|Venous Blood collection
15986159|NCT02991963|Other|Blood Smear|Slide blood smear
15986160|NCT02991950|Drug|Parnaparin Sodium|Parnaparin sodium ( Fluxum 4250 anti-Xa IU /0.4 mL or Fluxum 6400 anti-Xa IU /0.6mL; Alfa Wassermann S.p.A.) was administered at a dose of 100 IU/kg/day from the day before the beginning of the stimulation phase of the cycle until the result of the procedure was confirmed by pregnancy and, in the case of evolutive pregnancy, until delivery or the end of pregnancy
15986161|NCT02991937|Drug|Piperacillin/Tazobactam|24 hours of IV antibiotic administration
15986162|NCT02991937|Procedure|Surgical Treatment|Appendectomy
15986163|NCT02991911|Biological|MEDI3726 Post-Chemo|Single agent MEDI3726 after abiraterone or enzalutatmide, with a prior taxane-based chemotherapy in the mCRPC setting
15986164|NCT02991911|Biological|MEDI3726 Pre-Chemo|Single agent MEDI3726 after abiraterone or enzalutatmide, without a prior taxane-based chemotherapy in the mCRPC setting
15986165|NCT02991911|Biological|MEDI3726 & Enzalutamide Combo|MEDI3726 in combination with Enzalutatmide after prior treatment with abiraterone, with or without a prior taxane-based chemotherapy in the mCRPC setting
15986166|NCT02991898|Biological|Infusion of Treg|"Allopurinol on day -7 to day 0 Cyclophosphamide 50 mg/kg IV over 2 hours on day -6 Fludarabine 30mg/m2 IV over 1 hour on day -6, -5, -4, -3, and -2 Total Body Irradiation 200 cGy as a single dose
~Sirolimus 8mg-12mg oral loading dose followed by single dose 4mg/day. Levels are to be monitored 3 times/week in the first week, weekly until day +60, and as clinically indicated until day +100 post-transplantation.
~Mycophenolate Mofetil (MMF) 3 gram/day IV/PO divided in 2 or 3 doses. Stop MMF at day +30 or 7 days after neutrophil recovery, whichever day is later, if no acute GVHD.
~DUCBT followed Tregs - double umbilical cord blood transplant (FIRST) followed by the Treg cell infusion (SECOND) no sooner than 1 hour, but within 24 hours after the 2nd cord blood infusion."
15986167|NCT02991885|Biological|HAL-MPE1|Weekly subcutaneous administrations of HAL-MPE1
15986168|NCT02991885|Drug|HAL-MPE1 placebo|Weekly subcutaneous administrations of HAL-MPE1 placebo
15986434|NCT02989922|Biological|SHR-1210|SHR-1210 is a humanized anti-PD1 IgG4 monoclonal antibody
15986169|NCT02991872|Procedure|Blood draw|Subjects aged from ≥6 to ≤17 years at the time of enrolment in the parent clinical trial (following the CFDA post-marketing commitment requirement) and who received the full PEP rabies regimen as an intramuscular injection according to the vaccine group to which they were assigned in the V49_24 (NCT01680016) study will be invited to take part in this study. Single blood draw from subjects at Day-1/Visit-1. Subjects will be observed for 15 minutes after the blood draw.
15986170|NCT02991859|Drug|Fluticasone furoate (FF) Dry Powder Inhaler|Dry inhalation powder 25 mcg, 100 mcg, and 200 mcg per blister strip will be administered using ELLIPTA for both treatment periods
15986171|NCT02991859|Drug|Fluticasone propionate (FP) Dry Powder Inhaler|Dry Inhalation powder 50 mcg, 100 mcg, 250 mcg, and 500 mcg per blister strip will be administered using DISKUS for both treatment periods
15986172|NCT02991859|Drug|Budesonide (BUD) Turbuhaler|Budesonide comprises white to off-white rounded granules, which disintegrate to a fine powder upon slight pressure, will be administered using Turbuhaler for both treatment periods.
15986173|NCT02991859|Drug|Placebo (ELLIPTA or DISKUS)|Lactose dry powder inhaler will be administered using ELLIPTA or DISKUS for both treatment periods.
15986174|NCT02991833|Other|A New Incontinence Care Product|The novel incontinent care product is dressed and removed removed by opening both sides. In the part surrounding the waist and thights of the novel incontinent care product flexibility is achieved by planting rubber bien. When developing new incontinence care products was taken counselling from a faculty member from Department of Textile Engineering of one University Faculty of Engineering. The insurance policies was prepared for each patients attended to the study (Number: 481360).New care product is put on the experimental group. Perineal care was made to patients twice a day and after each defecation. After each perineal care, the novel incontinent care product was changed.
15986175|NCT02991833|Other|Diaper|In patients of the diaper group was used the optimum adult diaper (Pads, Linea TENA, SCA, Hygiene, Goteborg, Sweden) which was available in the market. Perineal care was made to patients twice a day and after each defecation. After each perineal care, the diaper was changed.
15986176|NCT02991820|Device|Miller|Direct laryngoscopy and endotracheal intubation attempted by each provider using direct laryngoscopy (DL) with a Miller laryngoscope
15986177|NCT02991820|Device|Macintosh|Direct laryngoscopy and endotracheal intubation attempted by each provider using DL with a Macintosh laryngoscope
15986178|NCT02991820|Device|C-MAC|Indirect laryngoscopy and endotracheal intubation attempted by each provider using the C-MAC video laryngoscope
15986179|NCT02991820|Device|GlideScope|Indirect laryngoscopy and endotracheal intubation attempted by each provider using the GlideScope video laryngoscope
15986180|NCT02991807|Drug|RAD001|"RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
~Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time (delete: each day) in the morning after a light, nonfat breakfast."
15986181|NCT02991807|Drug|Placebo|"Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
~Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time (delete: each day) in the morning after a light, nonfat breakfast."
15986182|NCT02991794|Device|EinsteinVision 3D visualization system|Elective laparoscopic radical prostatectomy due to histologically proven prostate cancer using EinsteinVision® 3D visualization system.
15986183|NCT02991781|Other|Biofeedback and Neurofeedback Training|The protocol will consist of 5 sessions of skin temperature biofeedback and 20 sessions of a neurofeedback training protocol that will consist of Alpha-Theta ratio up-training. The aim of the training is to reach a crossover state, were initially Alpha activity will increase and then in a deeper state, the Theta activity will take over. This state is associated with a reverie and disidentification with problems, stress or traumatic experiences. Therefore, the subjects will learn how to increase their Theta/Alpha ratio.
15986184|NCT02991781|Drug|Varenicline use for smoking cessation|The protocol will consist 1 mg varenicline use twice daily following a 1-week titration for 3 months.
15986185|NCT02991781|Other|Sham Neurofeedback|Subjects will receive equal sessions of sham neurofeedback, and thus serve as a control group for the analysis and design of the study.
15986186|NCT02991781|Other|Passive Control|Subjects will not receive any intervention, but they will be measured via a clinical and psychometric evaluation with a time-difference of 3 months. This is equal to the intervention time. Hence, the subjects in this intervention type will serve as a control group for the analysis and design of the study.
15986187|NCT02991768|Drug|Entocort|A corticosteroid that decreases levels of inflammatory cytokines.
15986188|NCT02991768|Drug|Placebos|Placebo is matched to the study drug.
15986189|NCT02991742|Other|contrast media|Compare 2 contrast media
15986190|NCT02991729|Other|iPad-based decision aid|This is a novel decision aid developed by genetic counselors and Maternal Fetal Medicine physicians. It is used via an iPad and is interactive. It is available in English and Spanish has been piloted by 20 English and Spanish speaking women. It takes approximately 15 minutes to complete.
15986191|NCT02991729|Other|Genetic counseling appointment|All participants will undergo an approximately 15 minute educational genetic counseling appointment regarding aneuploidy screening options. Should family history concerns be identified on intake, this visit may be extended to include a discussion of additional issues.
15986192|NCT02991716|Other|recorded patients|No intervention applied, only recording of cutaneous ECG signal from specific points on the torsi
15986193|NCT02991703|Device|pOpmètre®|the pOpmètre® uses saturation sensors,
15986194|NCT02991703|Device|Sphygmocor|the Sphygmocor uses applanation tonometry
15986195|NCT02991690|Other|Hypothermia|To deliver intravascular hypothermia, an Alsius Icy CoolGuard® catheter (US Food and Drug Administration approved, Premarket Notification [510(k), K030421]; Alsius Corporation, Irvine, California) will be inserted through the femoral vein using a sterile technique. Patients will be cooled at a maximum rate (2-2.5 ºC/hr.) until they reach the target temperature (T 33 ºC), which will be maintained for 48 hours, and then re-warmed at 0.1 ºC/hr. until normothermia (T 37ºC) is achieved.
15987055|NCT02985242|Drug|Empagliflozin placebo|Placebo tablet manufactured to mimic Empagliflozin 25 mg film-coated tablet
15986198|NCT02991677|Behavioral|resistive training|Exercise physiologist supervised upper and lower extremity resistive training 3 times weekly for 12 weeks
15986199|NCT02991664|Other|Equia Forte|Glass ionomer restorative system
15986200|NCT02991664|Other|G-aenial Posterior|Micro hybrid composite resin
15986201|NCT02991651|Drug|IRX4204|RXR agonist
15986202|NCT02991651|Drug|erlotinib|inhibitor of phosphorylation of the tyrosine kinase associated with the epidermal growth factor receptor
15986203|NCT02991638|Drug|Ibrutinib|Relapsed / refractory chronic lymphocytic leukemia and Waldenstrom macroglobulinaemia (lymphoplasmacytic lymphoma): 420 mg daily Relapsed / refractory mantle cell lymphoma: 560 mg daily Relapsed / refractory indolent B-cell non-Hodgkin lymphoma: 560 mg daily Treatment is continued until disease progression
15986204|NCT02991625|Drug|Placebos|Positive treatment expectations will be induced by giving participants capsules containing inert material and telling them that the capsules contain an effective drug that has been approved for treating Chronic Back Pain. They will be requested to take two capsules twice a day and report their pain on paper forms organized as a calendar.
15986205|NCT02991625|Other|Waitlist|These Chronic Back Pain participants will not be given any placebos and will be requested to report their pain on paper forms organized as a calendar.
15986206|NCT02991625|Other|Healthy Controls|Healthy control participants will not receive a placebo drug or be put on a waitlist.
15986207|NCT02991612|Drug|Rifaximin|Patients receive Rifaximin 400mg bid for 2 months
15986208|NCT02991599|Biological|60 µg dose hepatitis B vaccine|three-dose, 60 µg per dose
15986209|NCT02991599|Biological|20 µg dose hepatitis B vaccine|three-dose, 20 µg per dose
15986210|NCT02991586|Behavioral|Dialectical Behaviour Therapy|Group of families
15986211|NCT02991573|Device|Prime & Bond Universal|Prime & Bond Universal
15986212|NCT02991573|Device|Ceram X|
15986213|NCT02991573|Device|Prime & Bond XP|Control
15986214|NCT02991573|Procedure|technique 1|
15986215|NCT02991573|Procedure|technique 2|
15986216|NCT02991560|Other|Strengthening exercises|The exercises consisted of 3 sets with 20 repetitions of wrist and elbow flexion; 2 sets with 10 repetitions of wrist extension strengthening starting with 50% of the maximum strength and density increasing the resistance each week; and finally, 2 sets with 10 repetitions of the wrist flexor and extensor muscle groups comprising 20 sec of stretching and 10 sec of relaxing using the healthy hand.
15986217|NCT02991560|Other|Intensive Physioytherapy|The treatment consisted of a cold pack (enclosed in a moist towel for 12 minutes around the elbow joint), TENS (in an asymmetrical biphasic wave form and burst modulation, current width 150 mms, pulse frequency 5 Hz), and deep transverse friction massage (2 minutes of application to the locally sensitive areas determined through palpation on anterolateral surface of lateral epicondyle) followed by home exercises.
15986218|NCT02991560|Device|Kinesio taping|Kinesio tape has been implemented on forearm of the patients for the treatment of lateral epicondylitis
15986219|NCT02991560|Device|Athletic taping|By athletic taping, similar effects with Kinesio taping were aimed to gain. Considering the McConnel principles
15986220|NCT02991547|Other|Observational|
15986221|NCT02991534|Behavioral|CV Toolkit Components|"Patient completes a CV self screener.
~Patient discusses CV risks factors with primary care providers and CV risks are documented and discussed for action steps and referrals.
~Patient will be recommended to attend a gender tailored facilitated workgroup - Gateways to Healthy Living to make specific SMART goals and commit to patient preferred services or program"
15986222|NCT02991521|Procedure|Fast exam|Positional change before Fast exam
15986223|NCT02991508|Drug|Placebo|
15986224|NCT02991508|Drug|Adrecizumab|
15986225|NCT02991495|Biological|Stamaril, Sanofi Pasteur|"Full dose
~Fractional dose: one fifth (1/5)"
15986226|NCT02991495|Biological|Yellow fever vaccine, Bio-Manguinhos|"Full dose
~Fractional dose: one fifth (1/5)"
15986227|NCT02991495|Biological|Yellow fever vaccine, Institut Pasteur|"Full dose
~Fractional dose: one fifth (1/5)"
15986228|NCT02991495|Biological|Yellow fever vaccine, Chumakov Institute|"Full dose
~Fractional dose: one fifth (1/5)"
15986229|NCT02991495|Biological|Yellow fever vaccine, Chumakov Institute|"Full dose
~Fractional dose: one fifth (1/5)"
15986230|NCT02991495|Biological|Yellow fever vaccine, Chumakov Institute|"Full dose
~Fractional dose: one fifth (1/5)"
15986231|NCT02991482|Drug|Pembrolizumab|Pembrolizumab (MK-3475) is a potent and highly selective humanised monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. This blockade enhances functional activity of the target lymphocytes to facilitate tumour regression and ultimately immune rejection.
15986232|NCT02991482|Drug|Gemcitabine|"Gemcitabine replaces one of the building blocks of nucleic acids, in this case cytidine, during DNA replication. The process arrests tumour growth, as new nucleosides cannot be attached to the faulty nucleoside, resulting in apoptosis (cellular suicide)."
15986233|NCT02991482|Drug|Vinorelbine|Vinorelbine is a vinca alkaloid cytotoxic chemotherapy that is available in intravenous and oral preparations with EMA licenses in lung cancer and breast cancer. Vinorelbine blocks mitosis in phase G2-M, causing cell death in interphase or at the following mitosis.
15986234|NCT02991469|Drug|Sarilumab SAR153191 (REGN88)|"Pharmaceutical form: Solution
~Route of administration: Subcutaneous"
15986235|NCT02991456|Drug|Rolapitant|single 180 mg dose by mouth
15986236|NCT02991456|Drug|Ondansetron|8 mg by mouth daily
15986237|NCT02991443|Behavioral|Mindfulness based stress reduction|Mindfulness based stress reduction consisted of 8 group sessions for parents of children with IBD
15986238|NCT02991430|Device|active neuromodulation for episodic migraine headache|Non-invasive brainstem neuromodulator. Active and placebo devices appear identical
15986239|NCT02991430|Device|placebo neuromodulation for episodic migraine headache|Sham non-invasive brainstem neuromodulator. Active and placebo devices appear identical
15986240|NCT02991417|Biological|CDVAX|
15986241|NCT02991404|Procedure|Multimodal Peripheral Nerve Block Injection|After successful placement of the adductor canal catheter placed in standard fashion , the patient will receive a one-time 20 ml bolus of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, and 1:400,000 epinephrine followed by a continuous infusion of 0.125% bupivacaine set at 10ml/hour.
15986370|NCT02990416|Radiation|Ionizing Radiation|Electromagnetic or corpuscular radiation capable of producing ions, directly or indirectly, in its passage through matter.
15986242|NCT02991404|Procedure|Single Shot Adductor Canal Block|A total of 20 ml of solution containing a combination of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, 150 micrograms of buprenorphine, 2 mg of dexamethasone, and 1:400,000 epinephrine will be administered underneath the Sartorius muscle. A sham catheter will then be placed subcutaneously into the Sartorius muscle, secured in typical fashion, and connected to a pump containing saline to provide similar shape and weight with an opaque bag covering the pump. The pump will be run at the lowest possible ml/hour rate, which is currently 0.1 ml/hour with the current pump used in our hospital.
15986243|NCT02991404|Drug|Initial Bolus|20 ml bolus of 0.25% bupivacaine, 1.67 mcg/ml of clonidine, and 1:400,000 epinephrine
15986244|NCT02991404|Drug|Continuous infusion|Continuous infusion of 0.125% bupivacaine
15986245|NCT02991391|Other|None, use of a questionnaire|Telephone health survey using 2015 Behavioral Risk Factor Surveillance Survey in Texas, Florida, South Carolina, and Kentucky that includes questions regarding tobacco exposure and respiratory symptoms
15986246|NCT02991378|Behavioral|Children's emotional and stress coping program|Giving the children lessons about the emotional self-regulation skills and stress coping skills, with the psychoeducation books and lectures for the teachers and parents.
15986247|NCT02991365|Other|nasal insulin|
15986248|NCT02991365|Other|placebo spray|
15986249|NCT02991352|Device|Image guided needle placement|Stereotactic MRI based image guidance to aid in the placement of percutaneous needles into vascular malformations using a CE marked navigation system (CAS-One IR, CAScination AG)
15986250|NCT02991339|Drug|Dexamethasone|Dexamethasone 10 mg iv for 2 days; then 5 mg iv for 1 day
15986251|NCT02991326|Other|Osteopathic Manipulative Treatment|"The Osteopathic manipulative treatment will follow the approach bellow (using latex gloves for intra oral techniques):
~Compression of the fourth ventricle;
~inhibitory intra-oral pressure technique (IPT) of the temporal muscle;
~inhibition of the inferior head of the lateral pterygoid muscle;
~intra-oral inhibition of the masseter muscle;
~Balanced ligamentous tension (BLT) of the accessory ligaments - sphenopalatine;
~BLT of the accessory ligaments - pterygomandibular raphe;
~sphenopalatine ganglion technique;
~Craniosacral rebalancing;"
15986252|NCT02991326|Other|Sham intervention|The sham intervention will be made in the same examination table and the same position, with the use of the latex gloves, to simulate the Osteopathic Manipulative Treatment, only doing simple touches without therapeutic effect intention.
15986253|NCT02991313|Device|Endocardial Ablation Procedure|
15986254|NCT02991300|Device|BioPoly RS Partial Resurfacing Patella Implant|
15986255|NCT02991287|Procedure|Inguinal hernia repair|
15986256|NCT02991287|Procedure|Abdominal hysterectomy|
15986257|NCT02991287|Procedure|Vaginal hysterectomy|
15986258|NCT02991287|Procedure|Thoracotomy|
15986259|NCT02991274|Procedure|genomic testing of T790M mutation|patients will need to have genomic testing of T790M mutation at hospital laboratories and in central laboratory.
15986260|NCT02991261|Drug|SPARC001 type I|Treatment type I
15986261|NCT02991261|Drug|SPARC001 type II|Treatment type II
15986262|NCT02991261|Drug|Reference001 type I|Hydrocodone-acetaminophen
15986263|NCT02991261|Drug|Reference001 type II|Hydrocodone Acetaminophen
15986264|NCT02991248|Device|robotic training|robotic training by applying pelvis force perturbation
15986265|NCT02991248|Device|spinal cord electrical stimulation|Applying direct current electrical stimulation on spinal cord
15986266|NCT02991248|Device|treadmill|conventional treadmill training only
15986267|NCT02991235|Dietary Supplement|PRJ212|6 capsules of study product will be taken daily and orally.
15986268|NCT02991235|Dietary Supplement|Placebo|6 capsules of study product will be taken daily and orally.
15986269|NCT02991222|Drug|SPARC001 type I|Treatment type I
15986270|NCT02991222|Drug|SPARC001 type II|Treatment type II
15986271|NCT02991222|Drug|Reference001 type I|Hydrocodone-Acetaminophen
15986272|NCT02991222|Drug|Reference001 type II|Hydrocodone-Acetaminophen
15986273|NCT02991209|Drug|Testosterone|
15986274|NCT02991209|Drug|Placebos|
15986275|NCT02991196|Drug|DS-8273a + nivolumab|Nivolumab will be administered at 240 mg intravenously (IV) once every two weeks (Q2W) over 30 (± 5) minutes (on Days 1 and 15 of each cycle of 28 days). DS-8273a will be administered [90 (± 15) minutes on Day 1 of Cycle 1, and 60 (± 15) minutes in subsequent infusions] after the end of the nivolumab infusion in ascending doses up to 1200 mg IV Q2W. The regimen is adjusted based on injection site reactions or adverse events. Additional dose combinations may be considered based on the assessment of safety, primary pharmacodynamic (PDy) effects, and preliminary anti-tumor activities.
15986276|NCT02991183|Behavioral|ACT|A psychological therapy to help people i) notice and accept difficult thoughts and emotions; ii) identify what they value in life and iii) make changes to their behaviour to promote these values.
15986277|NCT02991170|Procedure|unipolar or bipolar radiofrequency ablation+CABG|Patients with myocardial infarction related potential malignant ventricular arrhythmia undergoing unipolar or bipolar radiofrequency ablation and Coronary Artery Bypass Grafts at the same time
15986278|NCT02991170|Procedure|CABG|Patients with myocardial infarction related potential malignant ventricular arrhythmia undergoing Coronary Artery Bypass Grafts
15986279|NCT02991157|Drug|Nimodipine|
15986280|NCT02991144|Genetic|scAAV8OTC|non-replicating, recombinant scAAV8 encoding human ornithine transcarbamylase (OTC)
15986281|NCT02991144|Drug|Oral prednisone|Initiated before dosing with DTX301, sustained for 4 weeks, followed by tapering
15986282|NCT02991131|Drug|Tedizolid (Sivextro, BAY1192631)|Antibiotic
15986283|NCT02991131|Drug|Linezolid|Antibiotic
15986284|NCT02991118|Drug|bempedoic acid|bempedoic acid 180 mg tablet taken orally, once daily. Patients remain on ongoing lipid-modifying therapy (not study provided)
15986285|NCT02991118|Drug|placebo|Matching placebo tablet taken orally, once daily. Patients remain on ongoing lipid-modifying therapy (not study provided)
15986367|NCT02990429|Procedure|Intravenous Fluid Warmer|"record room temperature
~record core temperature (tympanic membrane)
~General anesthesia
~using ranger warmer
~Intravenous fluid at room temperature
~room temperature and core temperature q15 minutes
~anesthesia finish, stop ranger warmer
~record core temperature before recovery room"
15986368|NCT02990416|Biological|A-dmDT390-bisFv(UCHT1)|anti-T cell immunotoxin (antibody targeting CD3 on T-cells tagged with diphtheria toxin without binding domain)
15986286|NCT02991092|Procedure|fluid administration|"After surgery, patients in the experiment group were provided with intravenous fluid administration at 1.0ml/Kg/h and encouraged to take food and drink water early after surgery, and the intravenous fluid administration was stopped immediately when the oral intake was more than 1500ml/h; patients in the control group strictly followed the fasting and were provided with the intravenous fluid administration according to Total amount of fluid = physiological requirement + additional loss (fever + gastrointestinal decompression) + amount lost until their intestinal function completely recovered."
15986287|NCT02991079|Other|Intervention group|"Smartphone with APP (EVIDENT) for 3 months, cardio-health rides and feeding workshop.
~Counseling on physical activity and Mediterranean diet."
15986288|NCT02991079|Other|Control: Lifestyle counseling|Conseling on physical activity and nutrition (intervention)
15986289|NCT02991053|Drug|ketamine|
15986290|NCT02991040|Device|Revanesse Ultra+ (with lidocaine)|Bilateral nasolabial fold trial to compare the safety and efficacy profiles of Revanesse® Ultra + (with lidocaine) to Revanesse® Ultra (comparator)
15986291|NCT02991040|Device|Revanesse Ultra|Comparator without lidocaine
15986294|NCT02991014|Behavioral|researcher-selected frequency-modulated music|Music pieces have been selected in advance by the researchers. Furthermore, musical frequencies have been artificially modulated.
15986295|NCT02991014|Behavioral|researcher-selected non-modulated music|The same music pieces as in the active comparator arm have been selected in advance by the researchers, but no artificial frequency modulation.
15986296|NCT02991014|Behavioral|participant-selected non-modulated music|Participants bring their own choice of personally preferred music pieces and listen to them during the intervention sessions. There is no frequency modulation in this condition.
15986297|NCT02991001|Procedure|Ultrasound-guided hydrodissection|Ultrasound-guided hydrodissection with 5cc normal saline between carpal tunnel and median nerve.
15986298|NCT02991001|Procedure|Placebo ultrasound-guided injection|Ultrasound-guided injection with 5cc normal saline at subcutaneous layer beyond carpal tunnel
15986299|NCT02991001|Device|Ultrasound|
15986300|NCT02991001|Drug|Normal Saline|
15986301|NCT02990975|Drug|ketamine|
15986302|NCT02990962|Drug|5% dextrose|Ultrasound-guided perineural injection with 5% dextrose (5cc) between carpal tunnel and surrounding median nerve with hydrodissection.
15986303|NCT02990962|Drug|1cc 2% Xylocaine+4cc Triamcinolone (40mg)|Ultrasound-guided perineural injection with1cc 2% Xylocaine+4cc Triamcinolone (40mg) between carpal tunnel and surrounding median nerve with hydrodissection.
15986304|NCT02990949|Other|Timing of trigger|
15986305|NCT02990936|Other|Tumor delineation|Measurement of tumor volume and neck nodes volume on a diagnostic CT and a pre-treatment CT by computerized delineation in order to calculate tumor growth velocity and tumor doubling time and describe tumoral kinetics patterns
15986306|NCT02990923|Device|High-Flow Needleless Valve|
15986307|NCT02990923|Device|DualCap Disinfection Devices|
15986308|NCT02990910|Drug|Individualized opioid analgesia|(a）positive result 10μg/kg morphine; negative result 50μg/kg morphine.
15986309|NCT02990910|Device|conventional opioid analgesia|(b) all received 25μg/kg morphine
15986311|NCT02990884|Drug|ketamine|
15986312|NCT02990871|Other|early neurological rehabilitation|start of neurological rehabilitation between 3rd and 15th day after ABI
15986313|NCT02990871|Other|no-early neurological rehabilitation|start of neurological rehabilitation between 20th and 90th day after ABI
15986314|NCT02990858|Drug|PRO 140 SC injections|
15986315|NCT02990845|Drug|Pembrolizumab/ Exemestane/ Leuprolide|Dose level 1 (Pembrolizumab 150 mg IV Q2W); Dose level -1 (Pembrolizumab 100 mg IV Q2W); Dose level -2 (Pembrolizumab 50 mg IV Q2W) Combination with Exemestane 25 mg PO QD, and Leuprolide 3.75 mg SC Q4W
15986316|NCT02990832|Device|Exciton|"Exsalt® Wound Dressings will be applied by the physician/nursing staff.
~The test product, exsalt® Wound Dressings (0.4 mg Ag/cm2) will be applied after wound cleansing or debridement if required.
~Dressings will be changed weekly, either at the out-patient facility or at home with provided dressings. At regular intervals throughout the study, as per the existing Diabetes Foot Care Clinical Care Pathway, wound assessment including size determination, Exsalt Wound Assessment Form, any adverse events will be reported, with tracing and/or photography included where available.
~Maximum treatment course will be 28 days (end of study) or until wound closure."
15986317|NCT02990819|Device|Apha/beta T and CD19+ cell depletion using CliniMACS device|Stem cells will be processed using the CliniMACS device for alpha/beta and CD19+ T cell depletion. Processing of cells using the CliniMACS will occur in accordance with the Investigator Brochure and Technical Manual following the laboratory SOPs and using aseptic technique.
15986318|NCT02990806|Biological|NI-071|20 ml vial containing 100 mg for a final reconstitution volume of 10 mg/mL
15986319|NCT02990806|Biological|Infliximab|20 ml vial containing 100 mg for a final reconstitution volume of 10 mg/mL
15986320|NCT02990793|Device|Active MeRT Treatment|A personalized biometrics-guided protocol known as magnetic EEG/ECG resonance therapy (MeRT) treatment that is tailored specifically to each participant's EEG intrinsic alpha frequency (IAF). rTMS is applied at the participant's IAF.
15986321|NCT02990793|Device|Sham MeRT Treatment|rTMS coil does not emit magnetic stimulation.
15986322|NCT02990780|Radiation|Conventionally fractionated concurrent chemo-radiotherapy|5Fx/W,2Gy/Fx,Dt:PTV-G:60Gy/30F/6W.
15986323|NCT02990780|Radiation|Accelerated hypofractionated concurrent chemo-radiotherapy|5Fx/W,2.5Gy/Fx,Dt:PTV-G:55Gy/22F/4.4W.
15986324|NCT02990754|Behavioral|Physical activity education|Instruction in suitable physical activity options and education about physical activity with CHD.
15986369|NCT02990416|Biological|Pembrolizumab|A humanized monoclonal immunoglobulin (Ig) G4 antibody directed against human cell surface receptor PD-1 (programmed death-1 or programmed cell death-1) with potential immune checkpoint inhibitory and antineoplastic activities.
15986371|NCT02990403|Drug|Aspirin|
15986372|NCT02990403|Drug|Heparin|
15986325|NCT02990728|Drug|Metformin|The enrolled patient is allocated to either LNG-IUS only or LNG-IUS + metformin by central randomization with study site allocation. A 90-100 days of continuous treatment before first histologic assessment of treatment response is required. The patient will receive endometrial curettage or hysteroscopic evaluation and resection of suspected lesion after 90-100 days of treatment. Patients with good response to assigned treatment will continue the treatment for another 90-100 days and second histologic assessment will be performed. Patients with poor response to assigned treatment at first assessment will receive additive oral progestin therapy, along with the assigned regimen(s) as, Oral progestin, either medroxyprogesterone acetate 500 mg daily or oral megestrol acetate 160 mg daily After a total of at least 6 months treatment period, the patient with good response at first assessment is suggested to keep the Mirena for maintenance until plan to get pregnant
15986326|NCT02990728|Device|Mirena®|
15986327|NCT02990715|Device|C-Scan System|"To establish the efficacy of C-Scan Capsule System and FIT in detecting patients with polypoid lesions ≥ 10mm, compared with Optical Colonoscopy
~To evaluate the safety of the C-Scan Capsule System procedure"
15986328|NCT02990702|Other|Ultrasound guided retroclavicular block|Ultrasound guided retroclavicular block for forearm or hand surgery
15986329|NCT02990702|Other|Ultrasound guided coracoid infraclavicular block|Ultrasound guided infraclavicular block for forearm or hand surgery
15986330|NCT02990702|Drug|Bupivacaine|
15986331|NCT02990702|Device|Ultrasound|
15986332|NCT02990689|Device|Trifocal Intraocular Lens|bifocal intraocular lens (IOL)
15986333|NCT02990689|Device|Bifocal Intraocular Lens|trifocal intraocular lens (IOL)
15986334|NCT02990689|Device|Low Addition Bifocal Intraocular Lens|low near addition intraocular lens (IOL)
15986335|NCT02990676|Behavioral|Computerised cognitive training|Computerised cognitive training regime
15986336|NCT02990663|Other|Use of blood pressure lowering medication at bedtime|Blood pressure lowering medications will be switched (one at a time as tolerated) to bedtime, or maintained at bedtime if already taken at that time. All decisions related to which, and how many, medications to switch are at the discretion of the care provider.
15986337|NCT02990663|Other|Use of blood pressure lowering medication in the morning|Blood pressure lowering medications will be switched (one at a time as tolerated) to morning, or maintained in the morning if already taken at that time. All decisions related to which, and how many, medications to switch are at the discretion of the care provider.
15986338|NCT02990650|Behavioral|Balance Task Training with therapist guarding support|"Nine balance tasks:
~long forward step
~forward reach
~push forward
~push backward
~step over hurdle
~step up on foam surface
~step up on solid surface
~sit-to-stand
~step onto slippery surface The therapist will provide guarding support"
15986339|NCT02990650|Behavioral|Balance task training with robotic guarding support|"Nine balance tasks:
~long forward step
~forward reach
~push forward
~push backward
~step over hurdle
~step up on foam surface
~step up on solid surface
~sit-to-stand
~step onto slippery surface The guarding support will be provided by a robot"
15986340|NCT02990650|Behavioral|Challneged balance task training with robotic guarding support|"Nine balance tasks where the subject is challenged to perform at a harder level of difficulty:
~long forward step
~forward reach
~push forward
~push backward
~step over hurdle
~step up on foam surface
~step up on solid surface
~sit-to-stand
~step onto slippery surface The guarding support will be provided by a robot"
15986341|NCT02990637|Dietary Supplement|OLECOL|Olive leaf extract
15986342|NCT02990637|Dietary Supplement|Placebo|Maltodextrin
15986343|NCT02990624|Radiation|PUVA|36 sessions of psoralen-ultraviolet A, divided as 3 sessions weekly
15986344|NCT02990585|Other|Back school|
15986345|NCT02990546|Drug|midodrine|Midodrine will be given to treatment arm as enteral medication
15986346|NCT02990546|Other|Standard of Care|Patients in the control arm will receive standard of care for septic shock
15986347|NCT02990533|Drug|Testosterone|
15986348|NCT02990533|Dietary Supplement|Protein Supplement|
15986349|NCT02990533|Other|Placebo Injection|
15986350|NCT02990533|Other|Placebo supplement|
15986351|NCT02990507|Other|AVEED: Arm rotation, video display|Participants rotate arm cranks for 5 minutes then rest for 5 minutes.
15986352|NCT02990507|Other|AVEED: Arm rotation, without video display|Participants rotate arm cranks for 5 minutes then rest for 5 minutes.
15986353|NCT02990507|Other|AVEED: Leg rotation, arm-energy input, video display|Participants rotate leg cranks for 5 minutes then rest for 5 minutes.
15986354|NCT02990507|Other|AVEED: Leg rotation, arm-energy input, without video display|Participants rotate leg cranks for 5 minutes then rest for 5 minutes.
15986355|NCT02990494|Behavioral|STANDARD|Standard Internet-delivered behavioral weight loss
15986356|NCT02990494|Behavioral|PREVENT|enhanced standard Internet-delivered behavioral weight loss program
15986357|NCT02990494|Behavioral|PROMOTE|enhanced standard Internet-delivered behavioral weight loss program
15986361|NCT02990468|Drug|BMX-001|Subcutaneous injection.
15986362|NCT02990468|Radiation|Radiation Therapy|Patients will receive standard dose intensity modulated radiation therapy (IMRT).
15986363|NCT02990468|Drug|Cisplatin|Cisplatin will be administered per institution's standard of care practice.
15986364|NCT02990455|Drug|Reduced nicotine cigarettes|Participants will be assigned to undergo two experimental conditions (i.e., exclusive smoking of RNC Low or Moderate in their home environment for 7 days) in a double-blind, randomized, crossover design. The two experimental conditions will be separated by a 7-day period of return to smoking of participants' own brand of cigarette.
15986365|NCT02990442|Device|rTMS|repetitive transcranial magnetic stimulation, 1Hz protocol to right dorsolateral pre frontal cortex (R_DLPFC)
15986366|NCT02990429|Procedure|Forced Air warmer|"record room temperature
~record core temperature (tympanic membrane)
~General anesthesia
~using forced air warmer (bair hugger)
~Intravenous fluid at room temperature
~room temperature and core temperature q15 minutes
~anesthesia finish, stop bair hugger
~record core temperature before recovery room"
15986376|NCT02990377|Behavioral|RL-supported IVR intervention|Participants in the intervention group receive interactive voice response calls where they are asked to report information about their health and medications using their touch-tone phone. Based on their responses, participants may receive brief or extended motivational messages during the call, or they may be assigned to receive a 20 minute motivational enhancement session with a study therapist over the phone.
15986377|NCT02990364|Drug|Sucrose|Sucrose was given to three out of the 4 intervention groups, to assess its effectiveness in managing pain during circumcision.
15986378|NCT02990364|Drug|Lidocaine|Lidocaine was given as a local anesthetic via Ring and Dorsal Penile Block to two of the intervention groups, in combination with the topical cream EMLA and sucking on sucrose.
15986379|NCT02990364|Drug|EMLA Topical Product|EMLA cream will be applied 70 minutes to the circumcision to all participants of the study.
15986380|NCT02990351|Procedure|loco regional therapies for HCC|29 HCC patients received locoregonal therapy as a bridging therapy for those who were within milan and as downstaging for those were initially beyond milan. The main LRT types used for our patients were TACE and or RFA and microwave ablation
15986384|NCT02990325|Drug|ABX464 150mg|ABX464 given orally at 150 mg per day from Day 0 to Day 28 (Cohort 1/ HIV infected subjects)
15986385|NCT02990325|Drug|ABX464 50mg|ABX464 given orally at 50 mg per day from Day 0 to Day 84 (Cohort 3 / HIV infected subjects) or from Day 0 to Day 28 (Cohort 2 / non HIV infected subjects)
15986386|NCT02990312|Drug|Sirolimus + Maraviroc|Patients will be placed on the combination of Sirolimus and Maraviroc starting on Day 0 and followed for 96 weeks during which they will have regular monitoring of both clinical safety labs, Sirolimus levels, and research labs to look at the HIV reservoir, CCR5 density, and immune activation
15986387|NCT02990299|Behavioral|mHealth for Diabetes Adherence Support|Participants will be paired with a health coach who will provide ongoing support and resources in medication and lifestyle adherence and diabetes self-management. The health coach will perform regular home visits, telephone support and tailored text-messages based on the participant's preferences and needs. They will help assess barriers to adherence and use motivational interviewing to help patients set goals and create action plans. They will also facilitate videoconferences with an assigned clinical pharmacist who will provide consultation on medication use, reconciliation and adherence, identify therapeutic goals and formulate an approved plan of care.
15986388|NCT02990286|Drug|Rituximab|Rituximab 500mg concentrate for solution for infusion. One course of IV rituximab consisting of a first infusion of 1000 mg (500 ml solution) rituximab (day 1 infusion), and a second infusion of 1000 mg (500 ml solution) rituximab two weeks later (day 15 infusion)
15986389|NCT02990286|Drug|Placebo of Rituximab|500 ml of saline (0.9% sodium chloride) for infusion One course of intravenous placebo of rituximab consisting of a first infusion of 500 ml of saline (0.9% sodium chloride) infusion (day 1 infusion), and a second infusion of 500 ml of saline infusion two weeks later (day 15 infusion)
15986390|NCT02990286|Drug|Mycophenolate Mofetil|"Mycophenolate Mofetil 500mg film-coated tablets
~1 gram twice daily on oral route of MMF (= 2 grams daily) for 6 months."
15986391|NCT02990273|Biological|Blood transfusion|
15986392|NCT02990260|Dietary Supplement|Saccharomyces cerevisiae|Live Saccharomyces cerevisiae
15986393|NCT02990260|Dietary Supplement|Lynside Wall Basic|yeast cell walls
15986394|NCT02990260|Dietary Supplement|Placebo|Maize starch and magnesium stearate
15986395|NCT02990247|Device|anharmonic morphological analysis of the respiratory signals (AMARS)|
15986396|NCT02990234|Procedure|Capsular Repair|
15986397|NCT02990234|Procedure|No Capsular Repair|
15986398|NCT02990221|Drug|Ingenol mebutate|150 mcg / g per day, to be applied on a predetermined area of 25 cm2 of skin of the face or scalp, for 3 days consecutive
15986399|NCT02990221|Procedure|cryotherapy|application with 5 seconds of freezing time of each lesion located in a predetermined skin area of 25 cm2 of the face or scalp
15986400|NCT02990208|Behavioral|Diaphragmatic breathing|Patients trained in the technique of diaphragmatic breathing were instructed to take a breath by contracting the diaphragm and were trained to maintain their respiration frequency. They were told to inhale through the nose for four seconds and exhale through the mouth for six seconds (six cycles per minute). Patients then had five minutes to practice by following verbal breathing instructions provided over headphones. During VR exposure breathing instructions were provided via headphones. Diaphragmatic is thought to reduce arousal on the physiological level (Hazlett-Stevens & Craske, 2009) but at the same time not to divert attention from the feared situation to the same extent as other coping strategies
15986401|NCT02990208|Behavioral|Virtual Reality Exposure Therapy|Exposure to fear-evoking stimuli is conducted more often in virtual environments using simulators or similar computer-technologies (Virtual Reality Exposure Therapy, VRET). One great advantage of using VR-technologies is that it is possible to create an environment which is highly controllable by its creators. Feared stimuli or scenarios can be varied on individual purposes and presented several times. This facilitates the practice of exposure-based treatments especially for situations or places difficult to access or requiring a considerable amount of time and/or money (e.g. being in war zones or a passenger on a flight), where in vivo exposures have often not been conducted or only in a limited manner (Mühlberger & Pauli, 2011)
15986402|NCT02990195|Other|Chyme reinfusion|
15986403|NCT02990169|Device|CATS tonometer prism|IOP tonometer prism for assessment of intraocular pressure
15986404|NCT02990169|Device|Goldmann Tonometer prism|IOP tonometer prism for assessment of intraocular pressure
15986405|NCT02990156|Device|Coil Embolization System|deposits coils in the aneurysm sac by electrolytical detachment; coil types include Complex Finish, Complex Frame, and Helical. The coils are made of a platinum - tungsten alloy, have a minimum diameter of 2 mm and a maximum diameter of 24mm. The intended use of the Microport NeuroTech Coil Embolization System is for the endovascular embolization of intracranial aneurysms.
15986406|NCT02990156|Device|Cotrol device from Medronic|Control device from Medronic (include AxiumTM Detachable Coils and AxiumTM Prime Detachable Coils) are manufactured by ev3 (Medtronic, Irvine, California, USA);
15987056|NCT02985242|Drug|Glimepiride placebo|Placebo tablet manufactured to mimic Glimepiride 2 mg tablet
15986407|NCT02990143|Procedure|Ologen|Ologen® CM,a biodegradable scaffold matrix, induces a regenerative non-scarring wound healing process without using anti-fibrotic agents.
15986408|NCT02990130|Other|Observational|
15986409|NCT02990117|Other|No Intervention|No Intervention
15986410|NCT02990091|Drug|Omega 3 fatty acid|LOVAZA is an FDA approved drug that is lawfully marketed in the United States by GlaxoSmithKline. There is no intent to use the results of this study to support a change in the labeling or the advertising of the drug. The highest dose administered for the study is the recommended prescribed dose of LOVAZA, therefore not creating greater risk. The patient population and route of administration will not significantly increase the risk associated with the use of the product. We will be using this drug under an IND exemption.
15986411|NCT02990091|Dietary Supplement|Safflower seed oil|Safflower seed oil is a commonly used dietary supplement. It has been chosen to be used as a comparative to the LOVAZA because of its non-omega-3 fats. There will be no increased risk due to dosage, route of administration, or patient population.
15986412|NCT02990078|Drug|Sildenafil citrate|Sildenafil is a potent and specific PDE5 inhibitor, which was initially developed for the treatment of hypertension and angina. Its effectiveness as a treatment for male erectile dysfunction became apparent during Phase I clinical trials, and the focus of drug development shifted to this indication. In patients with cerebrovascular dysfunction, a few preliminary studies have used sildenafil to increase CVR. Participants in the pilot study had CVR tested in response to hypercapnia measured twice, at baseline and then 1 hour after administration of sildenafil citrate, 50 mg by mouth. The investigators have an IND exemption for the uses in this study.
15986413|NCT02990078|Device|Functional Near Infared Spectroscopy|Functional near-infrared spectroscopy (fNIRS) will be used to measure regional cerebral blood flow and cerebrovascular reactivity. are connected to the scalp and surrounding detectors a few cm away detect the light as it scatters through the underlying tissues. The technique is able to detect changes in the absorption spectrum of the tissue corresponding to the concentrations of oxyhemoglobin (HbO2) and deoxyhemoglobin (HbR), and indicate local perfusion changes.
15986414|NCT02990078|Other|Hypercapnia Challenge|The study device is a Douglas Bag that traditionally is designed to measure respiratory exchange. It consists of large bag attached to a mouthpiece utilized to hold either expired air from the subject or filled with different concentrations of air to be aspired. For the purposes of this study, the Douglas Bag will be utilized to induce hypercapnia in the subject. The bag is equipped with a switch that allows rapid shifting from room air to 5% CO2 each minute over 7 minutes.
15986415|NCT02990065|Dietary Supplement|PROTEIN SUPPLEMENTATION|
15986416|NCT02990052|Procedure|Volar plating|Open reduction and volar fixed-angle plate fixation of distal radius fracture
15986417|NCT02990052|Procedure|Conservative treatment|Closed reduction & casting of distal radius fracture
15986418|NCT02990039|Behavioral|Counseling letter|The intervention is based on the Health Action Process Approach. The first letter provides information on knowledge regarding sedentary time and physical activity as well as intervenes on self-efficacy depending on the mindset of participants (non-intender, intender, actor). The second letter focuses on benefits and barriers of physical activity as well as the role of social support for physical activity. In case of actional stage, the third letter intervenes on self-efficacy again and suggests action and coping planning. Otherwise, the letter includes ipsative feedback according to the second letter.
15986419|NCT02990026|Behavioral|Specialty Mental Health Probation|Specialty mental health probation includes the following components: (1) exclusively mentally ill caseload of probationers; (2) reduced caseload of 40-45 probationers; (3) problem-solving supervision orientation; (4) ongoing training and consultation; and (5) greater connection with local mental health services
15986420|NCT02990013|Device|Avenova|Subjects will all undergo the treatment arm where their skin will be cleansed with four different agents: AvenovaTM , povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol
15986421|NCT02990013|Drug|Povidone-iodine 5% solution|Subjects will all undergo the treatment arm where their skin will be cleansed with four different agents: AvenovaTM , povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol
15986422|NCT02990013|Drug|4% chlorhexidine|Subjects will all undergo the treatment arm where their skin will be cleansed with four different agents: AvenovaTM , povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol
15986423|NCT02990013|Drug|Isopropyl alcohol|Subjects will all undergo the treatment arm where their skin will be cleansed with four different agents: AvenovaTM , povidone-iodine 5% solution, 4% chlorhexidine and isopropyl alcohol
15986424|NCT02990000|Behavioral|Scientific Match|We have developed an innovative, personalized Match System based on provider track records determined with a multidimensional outcomes tool - the Treatment Outcome Package (TOP). Specifically, patients are assigned to therapists with previously established strengths (i.e., being historically effective) in treating their primary problems (e.g., depression, anxiety).
15986425|NCT02989987|Behavioral|Narrative Exposure Therapy|
15986426|NCT02989987|Behavioral|Social Support|A local counselors provides social support on demand.
15986427|NCT02989974|Behavioral|KY LEADS Survivorship Care|"Survivor: Survivor questionnaire 1 at enrollment; KY LEADS Survivorship Care Program; survivor questionnaire 2 one week after program completion; survivor questionnaire 3 six months after enrollment.
~Caregiver: Caregiver questionnaire 1 at enrollment;KY LEADS Survivorship Care Program; caregiver questionnaire 2 one week after program completion; caregiver questionnaire 3 six months after enrollment"
15986428|NCT02989961|Other|Resticutis|Autologous, Activated-Platelets type of Preparation
15986429|NCT02989961|Other|Platelet-Poor Plasma (PPP)|A preparation of low platelet plasma obtained by a high-speed centrifugation step.
15986430|NCT02989948|Device|Physician-modified aortic endograft|Use of physician-modified fenestrated Cook Zenith Alpha Thoracic Endovascular Graft for the endovascular treatment of asymptomatic, non-ruptured thoracoabdominal aortic aneurysms of any Crawford extent (I-V) meeting traditional size criteria for open surgical repair.
15986431|NCT02989935|Procedure|Ventilation|Measurements of ventilation with subjects seated, and breathing across a pneumotachygraph and pressure transducer to measure inspiratory airflow, during both resting and CO2 stimulated breathing.
15986432|NCT02989935|Procedure|Parasternal EMG|Recordings of electrical activity (EMG) from the parasternal intercostal muscle in the second intercostal space on the upper anterior chest wall adjacent to the sternum.
15986433|NCT02989935|Procedure|Phrenic magnetic stimulation|Bilateral maximal magnetic stimulation (Magstim) of the phrenic nerves.
15986435|NCT02989909|Device|CATS tonometer prism|demonstrate that not more than 5% of the paired differences between the reference tonometer (CATS prism) reading and the test tonometer (Goldmann prism) reading for each pressure range
15986436|NCT02989909|Device|Goldmann tonometer prism|demonstrate that not more than 5% of the paired differences between the reference tonometer (CATS prism) reading and the test tonometer (Goldmann prism) reading for each pressure range
15986437|NCT02989896|Device|perfusion index|
15986438|NCT02989883|Other|peroral endoscopic myotomy|The procedure consists of four steps: 1) mucosal incision 10-15 cm above the esophagogastric junction to allow entry into the submucosa, 2) creation of a submucosal tunnel until the lower esophageal sphincter is reached, 3) myotomy of the circular muscle layer, and 4) closure of the mucosal entry with endoclips.
15986439|NCT02989870|Radiation|Stereotactic Body Radiation Therapy (SBRT)|"Participants will receive 3-5 fractions of radiation as determined by the dose level at time of enrollment. The starting dose level will be Dose Level 1: 8 Gy x 3 fractions for a total of 24 Gy. If sufficient treatment related toxicity is observed at the initial starting dose, then the dose will be reduced to 16 Gy in 2 fractions of 8 Gy. The dose per fraction for each participant will be provided at the time of registration based on the toxicity experience of the previous participants on study. This will be escalated to 40 Gy in 5 fractions of 8 Gy."
15986440|NCT02989870|Drug|Sorafenib|Sorafenib by mouth (PO): 200 mg twice a day (BID) then 400 mg BID.
15986441|NCT02989870|Drug|Bavituximab|Bavituximab intravenously (IV): 3 mg/kg every week (q wk).
15986442|NCT02989857|Drug|AG-120|
15986443|NCT02989857|Drug|AG-120 matched placebo|
15986444|NCT02989844|Drug|N-803|N-803 at 6 mcg/kg SQ Day 1 of a 4 week (28 day) cycle with ± 1 week window Continue N-803 every 4 weeks for 10 doses or until relapse, unacceptable toxicity, or patient refusal, whichever comes earlier.
15986445|NCT02989831|Device|Vibrating insoles 'on'|Duration: 30-60 seconds
15986446|NCT02989818|Other|Endoscopic Submucosal Dissection|This intervention is part of the subjects standard of care and is a method to remove the Gastrointestinal lesion.
15986447|NCT02989805|Behavioral|Care Management|Professionals and peers will each deliver the same intervention. The intervention combines a traditional medical model of care management with a recovery-based approach.
15986448|NCT02989792|Genetic|Blood sampling for genotyping|Venous punction of maximum 10 millilitres
15986449|NCT02989792|Other|Personality Questionnaires completion|Completion of the following questionnaires: Multidimensional Personality Questionnaire (MPSQ), Interpersonal Reactivity Index (IRI) and Behavioral inhibition system/ Behavioral activation systems (BISBAS) questionnaires
15986450|NCT02989779|Drug|NK1 Antagonist|
15986451|NCT02989779|Drug|Placebo Oral Capsule|
15986452|NCT02989766|Behavioral|Education on Breast Feeding|Subjects in the intervention arm will complete 3 activity sheets prenatally-study related.
15986453|NCT02989753|Dietary Supplement|VAL070-A|After randomization (V1 visit), 8 capsules per day of VAL070-A during 12 weeks (from visit V1 to visit V2). They will consume 3 capsules at the beginning of their breakfast, 2 capsules at the beginning of their lunch and 3 capsules at the beginning of their dinner.
15986454|NCT02989753|Dietary Supplement|VAL070-B|After randomization (V1 visit), 8 capsules per day of VAL070-B during 12 weeks (from visit V1 to visit V2). They will consume 3 capsules at the beginning of their breakfast, 2 capsules at the beginning of their lunch and 3 capsules at the beginning of their dinner.
15986455|NCT02989753|Dietary Supplement|Placebo|After randomization (V1 visit), 8 capsules per day of placebo during 12 weeks (from visit V1 to visit V2). They will consume 3 capsules at the beginning of their breakfast, 2 capsules at the beginning of their lunch and 3 capsules at the beginning of their dinner.
15986456|NCT02989740|Procedure|Optical Coherence Tomography|Patients aged ≥ 18 years bearing target lesions that fulfil the inclusion criteria and have undergone FFR and OCT imaging as per clinical practice will be enrolled in the study.
15986457|NCT02989727|Drug|Lamotrigine|Lamotrigine tablets at dosages of 25mg/day for Week 1 and Week 2, 50mg/day for Week 3 and Week 4, 100mg/day for Week 5, and 200mg/day for Week 6, Week 7, and Week 8.
15986458|NCT02989727|Drug|Placebos|Placebo tablets
15986459|NCT02989714|Drug|Interleukin-2|600,000 IU/kg/dose intravenously during two 5-day cycles 9 days apart
15986460|NCT02989714|Drug|Nivolumab|Nivolumab will be administered intravenously at 240 mg/dose over 60 minutes every 14 days, starting 1 week to 3 weeks after the start date of the first cycle of IL2 and continued for up to 48 weeks total in the absence of disease progression
15986461|NCT02989701|Drug|Plerixafor|Dose escalation of Plerixafor for Hematopoietic stem cell mobilization in patients with Sickle Cell Disease
15986462|NCT02989688|Dietary Supplement|Nepro HP (Abbott Nutrition)|oral nutritional supplement drink with modified carbohydrate composition
15986463|NCT02989688|Dietary Supplement|Fortisip compact protein 125 ml + Calogen 20ml (Nutricia)|Fortisip compact protein 125 ml + Calogen 20ml (Nutricia) oral nutritional supplement drink macronutrient matched with standard carbohydrate composition
15986464|NCT02989688|Dietary Supplement|Fortisip compact 125 ml (Nutricia)|Fortisip compact 125 ml (Nutricia) oral nutritional supplement drink - standard
15986465|NCT02989675|Drug|10% dextrose|Bolus of 10% dextrose 5mls/kg
15986466|NCT02989662|Drug|Mifepristone|Participants receive 6 doses.
15986467|NCT02989662|Drug|Placebo - Cap|Participants receive 6 doses
15986468|NCT02989649|Drug|Alogliptin|Alogliptin tablets
15986469|NCT02989649|Drug|Alogliptin FDC With Pioglitazone|Alogliptin FDC with pioglitazone tablets
15986470|NCT02989649|Drug|Alogliptin FDC With Metformin|Alogliptin FDC with metformin tablets
15986471|NCT02989636|Other|Laboratory Biomarker Analysis|Correlative studies
15986472|NCT02989636|Biological|Nivolumab|Given IV
15986473|NCT02989636|Radiation|Stereotactic Radiosurgery|Undergo SRS
15986474|NCT02989623|Radiation|Copper Cu 64 TP3805|Given Intravenously
15986475|NCT02989623|Procedure|Positron Emission Tomography and Computed Tomography Scan|Undergo copper Cu 64 TP3805 PET/CT scan
15986476|NCT02989610|Device|Omnidirectional stimulation|At the 3-month follow-up, therapeutic window, symptom relief and side effect thresholds are evaluated at the best level for omnidirectional stimulation with the Infinity DBS lead.
15986576|NCT02988843|Drug|Brentuximab Vedotin|Dose level 1: 1.8 mg/kg every 21 days (up to 180 mg) Dose level -1 :1.2 mg/kg every 21 days ( up to 120 mg)
15986477|NCT02989610|Device|Directional stimulation|At the 3-month follow-up, therapeutic window, symptom relief and side effect thresholds are evaluated using directional contacts at the best segmented level of the Infinity DBS lead.
15986478|NCT02989597|Drug|Methadone Hydrochloride|IV administration of methadone intra-operatively for a single dose
15986479|NCT02989597|Other|Standard pain regimen|Control
15986480|NCT02989584|Drug|Atezolizumab|
15986481|NCT02989584|Drug|Gemcitabine|
15986482|NCT02989584|Drug|Cisplatin|
15986483|NCT02989571|Drug|Intravenous normal saline administered at 250ml/hr|Intravenous normal saline administered at 250ml/hr
15986484|NCT02989571|Drug|Intravenous normal saline administered at 125ml/hr|Intravenous normal saline administered at 125ml/hr
15986485|NCT02989558|Drug|Ticagrelor plus ASA|Subjects in the Ticagrelor group will receive ASA 80mg qd 7 days prior to the TAVI procedure and for 90 days and Ticagrelor 90mg bid 1 day prior to the TAVI procedure and for 90 days.
15986486|NCT02989558|Drug|Clopidogrel plus ASA|Subjects in the Clopidogrel group will receive ASA 80mg qd 7 days prior to the TAVI procedure and for 90 days and Clopidogrel as a loading dose of 300 mg 1 day prior to the TAVI procedure and thereafter 75mg qd for 90 days.
15986487|NCT02989545|Device|Anal Tape|
15986488|NCT02989519|Drug|dydrogesterone|
15986489|NCT02989519|Drug|Micronized progesterone|
15986490|NCT02989493|Drug|Doxazosin|Doxazosin
15986491|NCT02989493|Other|Placebo|Placebo
15986492|NCT02989480|Radiation|PET CT|PET CT scans
15986493|NCT02989480|Other|Cardiac MRI|Cardiac MRI
15986494|NCT02989467|Drug|Aprepitant|Subjects will receive one tablet daily for 5 consecutive days. On Day 1 subjects will take a 125mg tablet, on Days 2-5, subjects will take an 80 mg tablet.
15986495|NCT02989467|Drug|Placebo|Subjects will receive one placebo tablet daily for 5 consecutive days.
15986496|NCT02989454|Other|Assessment of exercise capacity and cardiac energetics|Cardiopulmonary exercise testing and Magnetic Resonance Spectroscopy
15986497|NCT02989428|Procedure|Early parathyroidectomy group (EPTX-group)|Participants will undergo parathyroidectomy as soon as possible
15986498|NCT02989415|Other|Mechanical Ventilation|Mechanical ventilation during robotic surgery
15986499|NCT02989402|Drug|Rivastigmine|15 cm2 patch sizes loaded with 27 mg of rivastigmine
15986500|NCT02989389|Drug|LY3323795|Administered orally
15986501|NCT02989389|Drug|Itraconazole|Administered orally
15986502|NCT02989389|Drug|Placebo|Administered orally
15986503|NCT02989376|Procedure|After detection of occluded vessels by vascular imaging using carotid duplex ultrasound, digital subtraction angiography is immediately performed before acute endovascular treatment.|When the ratio of the end diastolic velocity in the common carotid arteries is greater than 1.4 or the diastolic flow in the internal carotid artery is not detected by vascular imaging using carotid duplex ultrasound, digital subtraction angiography is immediately performed before acute endovascular treatment. If vessel occlusion is not detected by carotid duplex ultrasound, additional vascular imaging including MR angiography or CT angiography is considered.
15986504|NCT02989363|Procedure|Device O-Arm in DBS|Deep brain stimulation surgeries with device O-Arm
15986505|NCT02989363|Procedure|Device O-Arm in RAQUIS|Complex back surgeries with the device O-Arm
15986506|NCT02989363|Procedure|Not device O-Arm in DBS|Deep brain stimulation surgeries without the device O-Arm
15986507|NCT02989363|Procedure|Not device O-Arm in RAQUIS|Complex back surgeries without the device O-Arm
15986508|NCT02989350|Dietary Supplement|Lactobacillus reuteri DSM 17938|Lactobacillus reuteri DSM 17938 vs Placebo
15986509|NCT02989350|Dietary Supplement|Placebo|Lactobacillus reuteri DSM 17938 vs Placebo
15986510|NCT02989324|Drug|MisoprostoL|Vaginal MisoprostoL
15986511|NCT02989324|Device|Foley Catheter|Misoprostol Plus Foley Catheter
15986512|NCT02989311|Dietary Supplement|Fortified maize porridge (MNP and Iron)|Maize porridge fortified with MNP and labelled iron compound
15986513|NCT02989311|Dietary Supplement|Fortified Maize porridge (MNP + Iron + GOS)|Maize porridge fortified with MNP + GOS and labelled iron compound
15986514|NCT02989298|Other|No intervention|Registration of all PD patients in the First Affiliated Hospital of Sun Yat-sen University and other hospitals，which have signed the contract in China.
15986515|NCT02989272|Drug|Sulfate, Magnesium|magnesium group (30 patients) who will receive pretreatment by intravenous infusion of magnesium sulfate 60 mg / kg
15986516|NCT02989272|Other|saline group|saline group (30 patients) who will receive pretreatment by saline solution
15986517|NCT02989259|Drug|Apatinib|apatinib 500mg p.o. qd
15986520|NCT02989233|Other|Non-surgical periodontal treatment|Scaling and oral hygiene instructions with brochure, model or video
15986521|NCT02989220|Other|Positive Reappraisal Coping Intervention|
15986522|NCT02989207|Procedure|Trabeculectomy|The current standard surgical treatment for glaucoma remains trabeculectomy. Wound healing modulation with antifibrotic agents, like MMC and 5-fluorouracil (5-FU), has been shown to increase the success of glaucoma filtering surgery in high-risk eyes
15986523|NCT02989207|Device|Baerveldt tube surgery|All glaucoma drainage devices consist of a tube which is inserted into the anterior chamber of the eye, draining aqueous humour to a plate which maintains a minimum bleb size and allows the collection of aqueous humour to be absorbed into the surrounding tissue.
15986524|NCT02989207|Drug|mitomycin-C|This is an anti scarring agent whcih is an standard adjunctive treatment in glaucoma surgery
15986525|NCT02989194|Drug|VIS410 low dose|Single intravenous fixed low dose of VIS410
15986526|NCT02989194|Drug|VIS410 high dose|Single intravenous fixed high dose of VIS410
15986527|NCT02989194|Drug|Placebo|Single intravenous infusion of placebo
15986528|NCT02989181|Device|Continues Positive Airway Pressure (CPAP)|Mask with positive airway pressure during exhalation which maintains the airway open
15986529|NCT02989168|Drug|GBT440|GBT440: Capsules which contain GBT440 drug substance in Swedish orange
15986577|NCT02988843|Drug|Bevacizumab|15 mg/kg every 21 days
15986578|NCT02988830|Device|Subcutaneous Electric Lumbar Stimulation|
15986530|NCT02989142|Behavioral|INTER-ACT|"Pre-conception coaching sessions: We encourage less motivated women to participate to the trial by collaborating with Kind & Gezin from the very beginning, as most timepoints of the counselling sessions coincide with the time points of the Kind&Gezin vaccine scheme (postpartum week 6, week 8, week 12, 6 months). We will organize the coaching in a mother and baby friendly community-based setting or in the hospitals, as preferred by the mothers.
~Pregnancy coaching sessions: take place in hospital, at the time of the three planned ultrasound scans.
~By consequence, the applied methodology can be applied as such at the moment of global utilisation in Flanders."
15986531|NCT02989129|Behavioral|Questionnaires|Questionnaires regarding quality of life, pain level, and related symptoms completed at Baseline and at End of Study Visit.. It should take less than 1 hour to complete these questionnaires.
15986532|NCT02989129|Drug|Quercetin|500 mg by mouth twice daily (after breakfast and dinner) for 12 weeks during study.
15986533|NCT02989116|Behavioral|Inhibition training|Inhibition training on a tactile tablet for a month (20 sessions of 15 min)
15986534|NCT02989116|Behavioral|Working memory training|Working memory training on a tactile tablet for a month (20 sessions of 15 min)
15986535|NCT02989116|Behavioral|Mindfulness training|Mindfulness training on a tactile tablet for a month (20 sessions of 15 min)
15986536|NCT02989116|Behavioral|Active control training|Active control training on a tactile tablet for a month (20 sessions of 15 min)
15986537|NCT02989116|Genetic|Saliva collection|Collection of a saliva sample for genotyping
15986538|NCT02989116|Procedure|Brain Magnetic Resonance Imaging|Structural and functional MRI
15986539|NCT02989116|Behavioral|Cognitive testing|Battery of cognitive and academic tasks on executive functions
15986540|NCT02989090|Other|Receive Detailed ICD Information-electronic|Receive Detailed ICD Information (Patient Notification Summary Report) via an electronic Patient Portal vs control
15986541|NCT02989090|Other|Receive Detailed ICD Information-paper|Receive Detailed ICD Information (Patient Notification Summary Report) via paper vs control
15986542|NCT02989064|Genetic|Autologous genetically modified MAGE A10ᶜ⁷⁹⁶T cells|Infusion of autologous genetically modified MAGE A10ᶜ⁷⁹⁶T on Day 1
15986543|NCT02989051|Other|Restrictive fluid regimen|In this treatment arm, patients will receive a maximal daily fluid intake of 70% of normal requirements (for a healthy child).
15986544|NCT02989051|Other|Liberal fluid regimen|This is considered current standard clinical treatment, wherein patients will receive a fluid regimen of >85% of normal fluid recommendations (for a healthy child).
15986545|NCT02989038|Other|Very Low Nicotine Content Cigarettes|cigarettes with 0.03 nicotine yield with 0.4 mg/g nicotine content and 9.0 mg tar yield
15986546|NCT02989038|Other|Intermediate Nicotine Content Cigarettes|cigarettes with 0.12 nicotine yield with 2.4 mg/g nicotine content and 9.0 mg tar yield
15986547|NCT02989038|Other|Normal Nicotine Content Cigarettes|cigarettes with 0.8 nicotine yield with 15.8 mg/g nicotine content and 10.5 mg tar yield
15986548|NCT02989025|Drug|17 OHPC|The study participant will be given 17 OHPC, 250mg IM at admission and every 7 days thereafter.
15986549|NCT02989012|Drug|GanMaoKangNing Granules|3 times a day, 2 bags each time.
15986550|NCT02989012|Drug|Analogous Oseltamivir Phosphate Capsules|2 times a day,1 capsule each time.
15986551|NCT02989012|Drug|Oseltamivir Phosphate Capsules|2 times a day,1 capsule each time.
15986552|NCT02989012|Drug|Analogous GanMaoKangNing Granules|3 times a day, 2 bags each time.
15986553|NCT02988999|Dietary Supplement|D-allulose|D-allulose (psicose), a C-3 epimer of D-fructose, is defined one of the rare sugars since it is rarely found in nature. Rare sugars are monosaccharides which present in small quantities in commercial mixtures of D-glucose and D-fructose obtained from hydrolysis of sucrose or isomerization of D-glucose (5). D-allulose (psicose) has been demonstrated to be a non-calorie monosaccharide which has approximately 70% sweetness of sucrose. Various physiological activities of D-allulose (psicose) have been revealed. Of those, its glucose suppressive effect has been proven by both animal and clinical studies.
15986554|NCT02988999|Dietary Supplement|erythritol|non-calorie sweetener
15986555|NCT02988986|Drug|TAK-228|MTORC1/2 inhibitor
15986556|NCT02988986|Drug|Tamoxifen|Non-steroidal anti-estrogen
15986557|NCT02988973|Drug|roxadustat|Oral administration
15986558|NCT02988973|Drug|DA|Subcutaneous administration
15986562|NCT02988947|Other|PNE+HyP|This is a combined PNE and Hypnosis psychological intervention. PNE is a cognitive based approach that highlights the biopsychosocial model of pain and focuses on neurophysiological and neurobiological processes and pain representation. Hypnosis aims at promoting pain control, increasing positive coping strategies, and targeting positive psychological variables.
15986563|NCT02988921|Device|MRI and CT|
15986564|NCT02988921|Radiation|Ratiotherapy|
15986565|NCT02988921|Drug|Paclitaxel, platinum-based drug|
15986566|NCT02988908|Drug|Donepezil|"Participants received donepezil as 5mg pills per day for 6 weeks, then 10 mg per day for the remainder of the 52-week trial.
~Participants also received 2 weeks of memory training at weeks 13-14"
15986567|NCT02988908|Drug|Placebos|"Participants received placebo as 5mg pills per day for 6 weeks, then 10 mg per day for the remainder of the 52-week trial.
~Participants also received 2 weeks of memory training at weeks 13-14"
15986568|NCT02988895|Radiation|episcleral brachytherapy|The study intervention is an outpatient, ambulatory procedure performed under local anesthesia with anesthesia assist.
15986569|NCT02988882|Drug|Dexamethasone|
15986570|NCT02988882|Other|Placebo Vehicle|
15986571|NCT02988869|Drug|Tiotropium/Formoterol|Tiotropium/Formoterol 18/12 mcg Inhalation Powder (1 puff) once daily via Discair®
15986572|NCT02988869|Drug|Tiotropium|Tiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler
15986573|NCT02988869|Drug|Formoterol|Formoterol 12 mcg Inhalation Powder (1 puff) twice daily via Aerolizer
15986574|NCT02988869|Drug|Tiotropium|Tiotropium 18 mcg Inhalation Powder (1 puff) once daily via Handihaler
15986575|NCT02988856|Device|Magnetic lid system|Small externally mounted magnetic lid arrays are attached to the eye lid (s). Glasses with a second magnet system may be combined with the arrays depending on the lid condition. The device intends to facilitate eye opening and closing.
15986579|NCT02988817|Biological|Enapotamab vedotin (HuMax-AXL-ADC)|All arms of the trial (both in escalation and expansion phase) will be administered enapotamab vedotin (HuMax-AXL-ADC)
15986580|NCT02988804|Device|endotracheal tube|"In the Endotracheal group In the ETT group, the procedure will be exactly the same except that the ETT will not be exchanged and the patient will be directly extubated
~Hemodynamic variables (blood pressure, HR, CO, rSO2, TCD) will be recorded at 8 moments:
~baseline, in the operating room before anesthetic induction (non invasive arterial pressure)
~end of surgery, before awakening (ETT group) or before ETT replacement (LMA group)
~at 1, 5, 10, 15, 30 and 60 min after extubation or LMA removal (according to group assignment)."
15986581|NCT02988804|Device|Laryngeal mask|"In the LMA group, after aspirating pharyngeal secretions and with the patient still under general anesthesia, we will insert a Proseal LMA (Laryngeal Mask Co. Ltd., Le Rocher, Victoria, Mahe Seychelles) and extubate the trachea using a guided Bailey technique
~Hemodynamic variables (blood pressure, HR, CO, rSO2, TCD) will be recorded at 8 moments:
~baseline, in the operating room before anesthetic induction (non invasive arterial pressure)
~end of surgery, before awakening (ETT group) or before ETT replacement (LMA group)
~at 1, 5, 10, 15, 30 and 60 min after extubation or LMA removal (according to group assignment)."
15986582|NCT02988791|Dietary Supplement|probiotic (BIfidobacterium, BB-12®)|probiotic (Bifidobacterium, BB-12®)
15986583|NCT02988791|Dietary Supplement|Placebo|Placebo
15986584|NCT02988778|Drug|Budesonid 50mcg (Noex)|Suspention to nasal use, 2 atomization in each nostril during the morning and at night.
15986585|NCT02988778|Drug|Budesonid 50mcg (Busonid)|Suspention to nasal use, 2 atomization in each nostril during the morning and at night.
15986586|NCT02988765|Procedure|Groin ultrasound +/- fine needle aspiration|"Preoperative ultrasound morphometry (USM) of the inguino-femoral lymph nodes (IFLN).
~The FNAC and/or FNAB is performed in case of suspicious nodes, if at least one of the selected criteria is relieved during ultrasound"
15986587|NCT02988752|Device|Electronic Mobile Device|Measure C/D Ratio With An Equipment Attached To A Ophthalmoscope That Will Determine C/D Ratio Without Touching Patient's Eyes. To Perform It We Need Mydriatic Conditions.
15986588|NCT02988752|Device|Optical Coherence Tomography|Measure C/D Ratio With OCT, Considered Gold Standard Equipment
15986589|NCT02988739|Biological|seasonal influenza vaccine|influenza vaccine containing 15 µg haemagglutinin of three seasonal influenza virus strains recommended by WHO
15986590|NCT02988739|Device|fractional Er:Yag laser|Fraction laser device to apply micorpores of defined depth and density into skin.
15986591|NCT02988726|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Adults with a recurrent/residual Neurofibroma or Schwannoma will receive Antineoplaston therapy (Atengenal + Astugenal).
15986592|NCT02988713|Device|Programming|Programming spinal cord stimulation (SCS) in patients undergoing a Boston Scientific (BSC) spinal cord stimulation (SCS) temporary trial
15986593|NCT02988700|Drug|Intrathecal hyperbaric bupivacaine 0.25mg/kg 0.5%|The lumber puncture will be made in the lateral position at the L4-5 or L5-S1 interspace with a 25 G pencil point Quincke spinal needle with a short bevel and the orifice of the spinal needle will be turned cephalad.
15986594|NCT02988700|Drug|caudal plain bupivacaine 2.5mg/kg 0.25%|"The sacral hiatus between the sacral conru will be palpated. While inserting the 23-G needle at 45° to the skin in the midline, a distance give or pop will be felt as the needle passes the sacral ligament into the caudal space, the needle will be tilted more toward the skin surface and inserted 2-3mm deeper."
15986595|NCT02988661|Behavioral|Chronic Disease Self-Management Program (CDSMP)|The CDSMP consist of 6 weekly classes of two and a half hours each one, for six weeks. A group of 10-16 people with different chronic conditions attend the classes together. Classes are facilitated by two certified leaders, one or both of whom are non-health professionals with chronic diseases. The workshop covers topics such as: 1) how to deal with frustration, fatigue, pain and isolation, 2) exercise for maintaining and improving strength, flexibility, and endurance, 3) communicating effectively with family, friends, and health professionals, 4) nutrition, 5) decision making, 6) appropriate use of medications and how to evaluate new treatments. Participants receive a companion book, Living a Healthy Life with Chronic Conditions, and an audio relaxation CD, Relaxation for Mind and Body.
15986596|NCT02988648|Radiation|Radioiodide (131I-)|The Phase I portion will follow a 3+3 design with 4 dose levels (30, 60, 120, and 200 mCi) of I- treatment. The maximum tolerated dose (from Phase I) will be used in the Phase II efficacy assessment which will follow a Simon's optimal two-stage design.
15986597|NCT02988635|Other|Early Palliative Care|Subjects who are randomized to the Standard Oncology Care with Early Palliative Care will meet with the palliative care team at their next medical oncology or infusion visit. They will meet with the palliative care clinician at least every three weeks. They will complete questionnaire at 12 weeks after enrollment.
15986598|NCT02988622|Device|Fraxel Laser|One half of the scar is treated with Fraxel Laser
15986599|NCT02988622|Device|CO2 Laser|One half of the scar is treated with CO2 Laser.
15986600|NCT02988609|Device|fMRI|fMRI at 3 different times after concussion: just after concussion (V1), once players have clinically recovered (V2) and 3 months after V2 (V3).
15986601|NCT02988596|Other|Multidimensional Active Rehabilitation|Participants will be asked to complete activities aimed at: stabilization of symptoms, impairment reduction, activity integration, recovery acceleration and sport specific application during a 20 minute session at least 4 times a week. Activities will be selected by the supervising clinician with respect to the specific impairment presentation of each participant. Session logs will be completed by each clinician and will include the following information: initial symptom checklist, activity parameters, percentage of rest during the session, participants rating of perceived exertion, and final symptom checklist, session satisfaction rating, and session feedback.
15986602|NCT02988596|Other|Enhanced Graded Exertion|Participants will be asked to use their symptoms to guide their activity from the time of their injury until they are asymptomatic. Once they are asymptomatic they will begin the graded exertion (Zurich/Berlin Protocol). During this time clinicians will complete session logs that include the following information: initial symptom checklist, phase of graded return to play progression, activity parameters, percentage of rest during the session, participants rating of perceived exertion, and final symptom checklist, session satisfaction rating, and session feedback.
15986603|NCT02988583|Device|Surgery using low viscosity silicone oil|Pars plans vitrectomy using low viscosity silicone oil
15986604|NCT02988583|Device|Surgery using high viscosity silicone oil|Pars plans vitrectomy using high viscosity silicone oil
15986605|NCT02988570|Behavioral|computer-evaluation of the language|A computer-evaluation of the language will be done for children born very preterm preterm in 2011 in the region of Haute-Normandie in France
15986606|NCT02988557|Procedure|walking on a treadmill with a sloped surface|walking on a treadmill with a sloped surface
15986607|NCT02988557|Device|treadmill|walking on a treadmill with a sloped surface
15986608|NCT02988544|Procedure|Artificial shrinkage|Artificial shrinkage of blastocyst
15986609|NCT02988531|Other|PET/MR scan|Patients to undergo PET/MR scanning after PET/CT scan. Patients will have had an injection of 18F Sodium Fluoride for their PET/CT therefore will not need another dose of radiotracer prior to their PET/MR scan.
15986610|NCT02988518|Behavioral|COGMED program|"Patient should connect on his computer at home, 5 times a week, for 5 weeks. Every day, the patient has to do 8 exercises for a total duration of 30 to 45 minutes.
~In total, the patient will have to complete 25 sessions. The difficulty level of the proposed items adjust automatically to the patient's maximum capacity to compel him to provide a cognitive effort. A progression index assesses the progress made by the patient.
~Every week, the investigator will call the patient for 10 minutes in order to gather the patient's feelings, his difficulties, provide some advice and encourage him.
~The investigator will have to analyze the results of curves available for each event, as well as the patient's progress index."
15986611|NCT02988505|Other|Standard care|
15986612|NCT02988492|Device|MRI perfusion imaging|Evaluate the sensitivity and specificity of whole---brain CTP in predicting 24 hour DWI---MRI infarct in patients with acute proximal anterior circulation occlusions successfully recanalized with endovascular treatment.
15986613|NCT02988479|Other|Out of pocket payments in patients|
15986614|NCT02988466|Biological|Haplo HCT <55 years old|"Fludarabine (Flu)
~Cyclophosphamide (Cy)
~Melphalan (Mel)
~Total body irradiation (TBI)
~Non-T-cell depleted donor bone marrow stem cell infusion Day 0"
15986615|NCT02988466|Biological|Haplo HCT ≥55 years old|"Fludarabine (Flu)
~Cyclophosphamide (Cy)
~Melphalan (Mel): Dose reduction by 30%
~Total body irradiation (TBI)
~Non-T-cell depleted donor bone marrow stem cell infusion"
15986616|NCT02988466|Drug|GVHD Prophylaxis|"Cyclophosphamide (Cy)
~Tacrolimus (Tac)
~Mycophenolate mofetil (MMF)"
15986617|NCT02988466|Biological|Haplo HCT ≥55 and < 65 years old|"Fludarabine (Flu)
~Cyclophosphamide (Cy)
~Melphalan (Mel)
~Total body irradiation (TBI)
~non-T-cell depleted donor bone marrow stem cells"
15986618|NCT02988466|Biological|Haplo HCT ≥65 and ≤75 years old|"Fludarabine (Flu)
~Cyclophosphamide (Cy)
~Total body irradiation (TBI)"
15986619|NCT02988453|Other|MBT-CD|MBT-CD is a disorder-specific modification of MBT, initially developed for patients with Borderline Personality Disorder. It is a manualized and psychodynamically oriented psychotherapy with the aim to increase the mentalization capacity of adolescents in close relationships. The therapy consists of 2 psychoeducational group sessions, 30 individual therapy sessions and 10 family sessions. The average duration of therapy is 6 months.
15986620|NCT02988440|Drug|PDR001|PDR001 will be administered intravenously
15986621|NCT02988440|Drug|Sorafenib|Sorafenib is formulated as a tablet.
15986622|NCT02988401|Drug|Insulin|All patients will receive either insulin or placebo using the Vianase III N2B device during the first 24 weeks of the study.
15986623|NCT02988401|Drug|Placebo (Sterile diluent)|All patients will receive either insulin or placebo using Vianase III N2B device during the first 24 weeks of the study.
15986624|NCT02988388|Procedure|Lung biopsy/lobectomy|Lung biopsies and lobectomies are not experimental. Participants will undergo a lung biopsy or a lobectomy as part of standard of care.
15986625|NCT02988375|Behavioral|dCBTI|
15986626|NCT02988375|Behavioral|Sleep Education|
15986627|NCT02988362|Drug|HL068 16/10mg|Candesartan 16mg and Amlodipine 10mg
15986628|NCT02988362|Drug|Candesartan 16mg and Amlodipine 10mg|
15986629|NCT02988349|Other|Colgate® Sensitive Pro-Relief® toothpaste|Subjects will be instructed to brush their teeth twice daily for 3 min using Colgate® Sensitive Pro-Relief® toothpaste for 2 weeks.
15986630|NCT02988323|Other|Cervicovestibular Physio (CV PT)|See description in CVPT arm
15986631|NCT02988323|Other|Low-Level Aerobic Exercise (LLAE)|See description in LLAE arm
15986632|NCT02988323|Other|Combination (LLAE and CV PT)|See description in LLAE and CVPT arm
15986633|NCT02988310|Other|No intervention|
15986634|NCT02988297|Drug|RNS60|Nebulized RNS60 will be administered by daily inhalation for 24 weeks.
15986635|NCT02988297|Drug|Placebo|Nebulized Placebo will be administered by daily inhalation for 24 weeks.
15986636|NCT02988284|Other|No intervention|
15986637|NCT02988271|Other|Interview|Participate in interview
15986638|NCT02988271|Procedure|Meditation Therapy|Complete meditation therapy
15986639|NCT02988271|Procedure|Quality-of-Life Assessment|Complete questionnaires
15986640|NCT02988271|Procedure|Supportive Care|Receive supportive care
15986641|NCT02988258|Genetic|CMV-TCR transduced donor-derived T cells|Dose escalation
15986642|NCT02988245|Drug|Geneticure Panel for HTN therapy|Using either Genetics (Geneticure for HTN multi-gene panel) or JNC-8 guidelines for prescribing for patients with hypertension
15986643|NCT02988245|Drug|JNC-8|Using JNC-8 guidelines to guide therapy
15986644|NCT02988232|Drug|Sogyeonghwalhyeol-tang|herbal extract
15986645|NCT02988232|Drug|Placebo|extract powder with same appearance, odor and color as SGHH
15986646|NCT02988219|Drug|Bupivacaine-fentanyl|Local anesthetic
15986647|NCT02988219|Device|Holter ECG monitor|3-chanel, CM5 leads
15986648|NCT02988219|Procedure|Open kidney cancer surgery|Lateral position
15986649|NCT02988219|Procedure|General anesthesia|
15986650|NCT02988219|Procedure|Epidural Anaesthesia|
15986651|NCT02988206|Behavioral|Personalized Objects|personalized objects are based on the observation or the reports from family
15986652|NCT02988206|Behavioral|non-personalized Objects|non-personalized objects are based on the suggestion in CRS-R,which are comb and cup
15986653|NCT02988193|Device|optima4BP Medication Management|A clinical reasoning expert system is used to determine the need for a medication treatment optimization. If a treatment optimization is needed, the expert system generates a recommendation that is sent to the treating physician.
15986821|NCT02987101|Drug|Adipose-Derived Regenerative Cells|Cells isolated from adipose-derived tissue will be injected locally around and under the wound.
15986654|NCT02988180|Other|basic services|The age-matched control children received the basic services such as family-home, food, clothing, health care, protection and education. However, they were not provided with the play-based developmental stimulation.
15986655|NCT02988180|Other|the play-based developmental stimulation|Children in the intervention group received basic services such as family-home, food, clothing, health care, protection and education for older children. In addition, there received play-based developmental stimulation integrated into the services.
15986656|NCT02988154|Other|Simulation training|Simulation training (computer simulation of the procedure, followed by simulation on a dead animal model).
15986657|NCT02988154|Other|''See one, do one'' approach|The participants watch an experienced surgeon perform the EVD placement, after which the participants attempt to perform the procedure independantly on the skull model.
15986660|NCT02988115|Drug|bempedoic acid|bempedoic acid 180 mg tablet
15986661|NCT02988115|Other|placebo|Matching placebo tablet
15986662|NCT02988102|Other|Following S100B and NSE in head trauma|Following S100B and NSE in head trauma in correlation with Head CT and post concussion syndrome and Lisat11
15986663|NCT02988089|Drug|Clarithromycin susceptibility dependant strategy|"Patients in this group will receive a 14-day bismuth-based quadruple regimen to eradicate H. pylori. Antimicrobial susceptibility testing (AST) will be used to test the susceptibility of clarithromycin.
~If clarithromycin is susceptible, amoxicillin 1 g b.i.d and clarithromycin 500 mg b.i.d will be chosen; If clarithromycin is resistant, amoxicillin 1 g bid and furazolidone 100 mg b.i.d will be chosen."
15986664|NCT02988089|Drug|2 susceptible antibiotics (amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline )|Patients in this group will receive a a 14-day bismuth-based quadruple regimen to eradicate H. pylori. The regimen is consist of a PPI, Colloidal Bismuth Pectin and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated.
15986665|NCT02988089|Drug|proton pump inhibitor (PPI) and Colloidal Bismuth Pectin|all patients need these two drugs.
15986666|NCT02988089|Drug|amoxicillin and clarithromycin or amoxicillin and furazolidone|patients in the 6 antibiotics dependant group will use these intervention.
15986667|NCT02988089|Drug|amoxicillin and furazolidone or amoxicillin and tetracycline|salvage therapy for negative culture when the results of culture are negative
15986668|NCT02988089|Drug|amoxicillin and furazolidone or amoxicillin and Tinidazole or amoxicillin and Levofloxacin|salvage therapy for failed eradication if failed with AST guided eradication therapy
15986669|NCT02988076|Device|PEER Interactive Report|A subinvestigator treating a Treatment Group subject will receive the Psychiatric Electroencephalogram Evaluation Registry (PEER) Interactive Report (of probable medication response) under investigation and will incorporate the Report information during prescription of medications to the Subject. A subinvestigator treating a Control Group subject will NOT receive the PEER Report and will treat the Subject with Standard of Care. The subject will be blinded to group assignment and will provide the primary outcome measure - Quick Inventory of Depressive Symptomatology - Self Report 16 item questionnaire.
15986670|NCT02988063|Drug|Polidocanol Endovenous Microfoam (PEM)|Polidocanol endovenous microfoam (PEM) is a sclerosing agent indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein system above and below the knee. PEM improves the symptoms of superficial venous incompetence and the appearance of visible varicosities.
15986671|NCT02988050|Drug|Remifentanil|Remifentanil used for conscious sedation.
15986672|NCT02988050|Drug|Dexmedetomidine|Dexmedetomidine used for conscious sedation.
15986673|NCT02988050|Drug|Propofol|Used for conscious sedation.
15986674|NCT02988050|Drug|Bupivacaine|Local anaesthetics
15986675|NCT02988050|Drug|Lidocaine|Local anaesthetic
15986676|NCT02988050|Drug|Epinephrine|With local anaesthetic for skin infiltration.
15986677|NCT02988037|Behavioral|A-DBT-A|Adapted Dialectical Behaviour Therapy for Adolescents
15986678|NCT02988024|Drug|LY03005|LY03005
15986679|NCT02988024|Drug|Pristiq|
15986680|NCT02988011|Procedure|Gastric by-pass surgery|Gastric by-pass surgery is expected to achieve a mean weight loss of 7-8kg in 4 weeks, which is similar weight-loss achieved in the other arm (low-caloric diet) during this time period.
15986681|NCT02988011|Dietary Supplement|Low-caloric diet|Energy restricted diet with a total energy intake of 800-1200kcal/day
15986682|NCT02987998|Drug|Cisplatin|Cisplatin (50mg/m2 IV D1, 8, 29, 36)
15986683|NCT02987998|Drug|Etoposide|Etoposide (50mg/m2 IV D1-5, 29-33)
15986684|NCT02987998|Drug|Pembrolizumab|Pembrolizumab (200mg IV D1, 21, 42)
15986685|NCT02987998|Drug|Radiation|Radiation (1.8Gy/D to 45Gy in 25 fractions)
15986686|NCT02987985|Drug|Acetaminophen, gabapentin|acetaminophen 15 mg/kg, gabapentin 10 mg/kg
15986687|NCT02987985|Drug|Acetaminophen|acetaminophen 15 mg/kg
15986688|NCT02987985|Drug|Ketamine , Lidocaine , Dexmedetomidine|Ketamine 0.5 mg/kg, Lidocaine 1 mg/kg, Dexmedetomidine 0.3 mcg/kg
15986689|NCT02987985|Drug|Fentanyl, Dexmedetomidine|Fentanyl 0.5 mcg/kg, Dexmedetomidine 0.3 mcg/kg
15986690|NCT02987985|Drug|Dexamethasone , Ondansetron|Dexamethasone 150 mcg/kg, Ondansetron 50 mg/kg
15986691|NCT02987985|Drug|Sevoflurane|Sevoflurane (dose titrated to effect)
15986692|NCT02987985|Drug|Sevoflurane, Fentanyl|Sevoflurane (dose titrated to effect), Fentanyl as needed (dose at anesthesiologist's discretion)
15986693|NCT02987972|Biological|V114 Lot 1|Lot 1: Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
15986694|NCT02987972|Biological|V114 Lot 2|Lot 2: Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose
15986695|NCT02987972|Biological|Prevnar 13™|Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose
15986822|NCT02987088|Drug|Sodium Nitrite|
15986823|NCT02987075|Other|Compacting embryo transferring|transfer of 2 utilizable compacting embryos
15986696|NCT02987959|Drug|TAK-228|TAK-228 is a novel, highly selective, orally bioavailable adenosine 5' triphosphate (ATP)-competitive inhibitor of the serine/threonine kinase referred to as the mechanistic target of rapamycin (mTOR). TAK-228 (formerly INK128) targets 2 distinct mTOR complexes, mTOR complex 1 (mTORC1) and mTOR complex 2 (mTORC2).
15986697|NCT02987946|Device|IPD Device delivered by Converis|After randomization patients will be subjected to perioperative (48 hrs) intermittent pneumatic compression.
15986698|NCT02987946|Drug|Fraxiparine|All patients receive Fraxiparine 2850 IE daily, starting preoperatively compatible with current practice.
15986699|NCT02987920|Drug|Dextromethorphan|Additional medication to perioperative analgesic regimen in Group B
15986700|NCT02987920|Drug|Placebo - Concentrate|Additional medication to perioperative analgesic regimen to Group A
15986701|NCT02987920|Drug|Acetaminophen|Multimodal analgesic regimen to Group A and Group B
15986702|NCT02987920|Drug|Oxycodone|Multimodal analgesic regimen to Group A and Group B
15986703|NCT02987920|Drug|Celecoxib|Multimodal analgesic regimen to Group A and Group B
15986704|NCT02987920|Drug|Pantoprazole|Multimodal analgesic regimen to Group A and Group B
15986705|NCT02987920|Drug|Ketorolac|Multimodal analgesic regimen to Group A and Group B
15986706|NCT02987920|Drug|Gabapentin|Multimodal analgesic regimen to Group A and Group B
15986707|NCT02987920|Drug|Hydromorphone|Multimodal analgesic regimen to Group A and Group B
15986708|NCT02987907|Drug|Dexamethasone|use dexamethasone 10mg (2ml) I.A. during TACE
15986709|NCT02987907|Drug|Normal Saline|use normal saline 2ml I.A. during TACE
15986710|NCT02987894|Device|ACURATE neo™ Aortic Bioprosthesis|TAVI, transcatheter aortic valve replacement. Transfemoral access.
15986711|NCT02987881|Behavioral|Home-based aerobic exercise and nutritional counseling|Moderate walking and running with nutritional counseling at study visits.
15986712|NCT02987868|Drug|Amino acid supplement first day|An orally administered supplement of the proprietary amino acid derivative
15986713|NCT02987868|Drug|Placebo first day|A non-active orally administered supplement of the proprietary amino acid derivative
15986714|NCT02987868|Drug|Amino acid supplement second day|An orally administered supplement of the proprietary amino acid derivative
15986715|NCT02987868|Drug|Placebo second day|A non-active orally administered supplement of the proprietary amino acid derivative
15986716|NCT02987855|Procedure|Lipoaspiration|Closed syringe harvesting subdermal fat
15986717|NCT02987855|Procedure|ADcSVF isolation|Isolation of AD-cSVF from lipoaspirate via enzymatic digestion
15986718|NCT02987855|Procedure|Normal Saline IV|Normal Saline IV containing autologous AD-cSVF
15986719|NCT02987842|Device|TruScan Neurofeedback|Neurofeedback and quantitative EEG system
15986720|NCT02987829|Drug|TRC253|TRC253 is a high-affinity, small molecule antagonist of the androgen receptor (AR) with inhibitory activity against wild type AR and specific mutated variants of AR. TRC253 blocks AR nuclear translocation as well as AR binding to DNA and is an antagonist of transcription for wild type AR and mutated AR. TRC253 is orally active and does not have agonist activity towards either the wild type or mutated ARs. TRC253 treatment in the Hershberger assay results in complete inhibition of androgen sensitive organ development. TRC253 is efficacious in an LNCaP xenograft model driven by F876L (also known as F877L) mutant AR.
15986721|NCT02987816|Device|Sham tDCS|NeuroConn Direct-Current Stimulator. Sham tDCS: 45 second ramp up to 1milliamp, 60 second current hold at 1milliamp, 45 second ramp down to 0milliamp. Anode positioned over the left primary motor cortex, and the cathode over the contralateral supraorbital area.
15986722|NCT02987816|Device|Anodal tDCS|NeuroConn Direct-Current Stimulator. Sham tDCS: 45 second ramp up to 1milliamp, 20 minute current hold at 1milliamp, 45 second ramp down to 0milliamp. Anode positioned over the left primary motor cortex, and the cathode over the contralateral supraorbital area.
15986724|NCT02987790|Other|C-reactive protein|PCR assays shall be performed daily on serum obtained from blood collected for routine intensive care examinations up to 2 days after antibiotic withdrawal. In the PCR group, antibiotic suspension will be encouraged when levels of this marker are <35mg / L (if peak PCR below 100mg / L); or reduce 50% of the highest value (if PCR peak> 100mg / L), with a limit of seven days, if there is clinical improvement.
15986725|NCT02987764|Other|cord milking|For infants in the cord milking group, the cord will be clamped at the longest distance possible and neonatal team will bring the infant to the resuscitation table for further care. The clinical care will be provided by the clinicians taking care of the infant. The research team will be trained and be responsible for requesting the obstetrician in advance to provide the maximum length of umbilical cord.
15986726|NCT02987751|Drug|Glargine + Glulisine|Glargine should be taken 30 minutes before breakfast/dinner, the dose is adjusted as per fasting blood glucose during each visit and Glulisine should be taken 20 minutes before breakfast/dinner, the dose is adjusted as per postprandial blood glucose during each visit
15986727|NCT02987751|Drug|Premixed analogue insulin (70/30)|Premixed analogue insulin should be taken 30 minutes before breakfast/dinner, the dose is adjusted as per fasting blood glucose during each visit.
15986728|NCT02987738|Drug|Dapagliflozin|two administrations in the evening and 12 hours later
15986729|NCT02987738|Drug|Placebo Oral Tablet|two administrations in the evening and 12 hours later
15986730|NCT02987725|Behavioral|Hypnosis|A 30-minute Hypnosis session with a trained clinician focused on relaxation and hypnotic suggestions for pain relief and reduced stress responses.
15986731|NCT02987725|Behavioral|Attention Control|A 30-minute historical story read by a research clinician.
15986732|NCT02987712|Other|Thromboelastography based protocol|patients will be treated according to a new thromboelastography based protocol
15986733|NCT02987699|Drug|5-Fu, oxaliplatin , leucovorin|Drug: 5-Fu, oxaliplatin and regular dose of leucovorin Regimen: (1) 5-Fu: 2800 mg/m2 (2) oxaliplatin: 135 mg/m2 (3) leucovorin: 400mg/m2
15986734|NCT02987699|Drug|5-Fu, oxaliplatin , leucovorin|Drug: 5-Fu, oxaliplatin and regular dosage of leucovorin Regimen: (1) 5-Fu: 1400 mg/m2 (2) oxaliplatin: 135 mg/m2 (3) leucovorin: 400mg/m2
15987211|NCT02984150|Dietary Supplement|dodecanoic acid|
15986735|NCT02987699|Drug|5-Fu, oxaliplatin , leucovorin|Drug: 5-Fu, oxaliplatin and regular dosage of leucovorin Regimen: (1) 5-Fu: 2800 mg/m2 (2) oxaliplatin: 85 mg/m2 (3) leucovorin: 400mg/m2
15986736|NCT02987686|Drug|Topical Infliximab|Aside from the standard treatment, patients will receive topical infliximab ( 10mg/ml) four (4) time per day for four (4) weeks.
15986737|NCT02987673|Procedure|MGB/OAGB|
15986738|NCT02987673|Procedure|LSG|
15986739|NCT02987660|Procedure|Topography Guided LASIK|Corneal surgery for refractive error correction
15986740|NCT02987660|Procedure|Small Incision Lenticular Extraction|Refractive surgical procedure for the correction of myopia with or without astigmatism
15986741|NCT02987660|Device|WaveLight EX500 Excimer Laser System|As used for corneal stroma ablation (refractive error correction). The treatment is intended to last the subject's lifetime.
15986742|NCT02987660|Device|VisuMax Surgical Laser|As used for lenticule creation/removal (refractive error correction). The treatment is intended to last the subject's lifetime.
15986743|NCT02987647|Other|Hidrafemme|The complete treatment will have followed four weeks of duration and application of the product should take place twice a week.
15986744|NCT02987647|Other|Vagidrat|The complete treatment will have followed four weeks of duration and application of the product should take place twice a week.
15986745|NCT02987647|Other|Lubrinat|The complete treatment will have followed four weeks of duration and application of the product should take place twice a week.
15986746|NCT02987647|Other|Antrofi|The complete treatment will have followed four weeks of duration and application of the product should take place twice a week.
15986747|NCT02987634|Other|PeriActive|mouthwash
15986748|NCT02987621|Device|tDCS|Less than 10V of Transcranial Direct Current Stimulation. Sham 0V of Transcranial Direct Current Stimulation.
15986749|NCT02987608|Device|Power Up|Smartphone phone app
15986750|NCT02987595|Other|Whole-grain rye, high lignan|Intervention week 1-8: 50 g rolled rye + 50 g puffs + 4 pieces of crisp bread + 70 g pasta. Additionally for intervention week 4-8: 4 lignan capsules per day
15986751|NCT02987595|Other|Whole-grain wheat, low lignan|Intervention week 1-8: 100 g puffs + 4 pieces of crisp bread + 70 g pasta.
15986753|NCT02987569|Behavioral|mConnect plus mobile connections to multidisciplinary professionals & peers|mConnect is the integration of evidence-based HPN interventions delivered via professionally moderated iPad visual meetings with peers, and reinforced by HPN related skill-building games (apps) and iPad music guided short naps.
15986754|NCT02987569|Behavioral|iPad use plus one mobile connections to multidisciplinary professionals & peers|iPad with a data plan and one professionally moderated iPad visual meeting with peers.
15986755|NCT02987556|Device|Continuous Glucose Monitoring|Collection of glucose data
15986756|NCT02987556|Device|External Insulin Pump|insulin delivery
15986757|NCT02987556|Other|telemdecine|Remote follow up by care health providers team
15986758|NCT02987556|Device|The Diabeloop Software (Model predictive control)|Diabeloop is a Closed-loop (CL) system with a Model Predictive Control (MPC) algorithm reinforced by a decisional matrix, uploaded on a dedicated android smartphone linked to Dexcom CGM and a Cellnovo or Kaleido insulin patch-pump. The Diabeloop software calculates the insulin dose according to the patient's needs.
15986759|NCT02987543|Drug|olaparib|300 mg (2x 150 mg tablets) twice daily
15986760|NCT02987543|Drug|enzalutamide|160 mg (4 x 40 mg capsules) once daily
15986761|NCT02987543|Drug|abiraterone acetate|1,000 mg (4 x 250 mg tablets) once daily
15986762|NCT02987543|Drug|abiraterone acetate|1,000 mg (2 x 500 mg tablets) once daily
15986763|NCT02987543|Drug|enzalutamide|160 mg (4 x 40 mg tablets) once daily
15986764|NCT02987530|Drug|Dolutegravir|Oral use, 50mg/day
15986765|NCT02987530|Drug|Darunavir-cobicistat|Oral use, 800-150mg/day
15986766|NCT02987530|Drug|Emtricitabine-Tenofovir|Oral use, Emtricititabine : 200mg/day Ténofovir : 245mg
15986767|NCT02987517|Other|Increased running cadence gait retraining|Runners use an increased cadence, or step rate, 7.5% greater than baseline preferred cadence
15986768|NCT02987517|Other|Forefoot Strike gait retraining|Runners use a forefoot strike running gait instead of a rear foot strike running gait.
15986769|NCT02987517|Other|Strengthening exercises|foot and ankle strengthening exercises performed by all subjects to prepare musculoskeletal tissues for requirements of new running gait.
15986770|NCT02987504|Drug|Samalizumab|Samalizumab is a humanized, anti CD200 monoclonal antibody provided as a sterile 5 mg/milliliters (mL) solution for IV administration.
15986771|NCT02987491|Behavioral|Exercise|Participants will perform 2 metabolic study days of either resting or acute bout of cycling exercise in a randomized cross-over design.
15986772|NCT02987465|Drug|Darbepoetin Alfa|Darbepoetin is not a study drug and is prescribed as part of routine treatment of anaemia in CKD1. Darbepoetin is licensed for use for the treatment of anaemia in the context of CKD. It will be provided as part of the standard clinical care of the renal patients in this study. Healthy Volunteers will not be treated with Darbepoetin.
15986773|NCT02987465|Drug|Acetylcholine|Acetylcholine is being used as a challenge agent in this study and assesses NO-mediated vasodilation
15986774|NCT02987465|Drug|Noradrenaline|Noradrenaline is being used as a challenge agent in this study and is an endogenous a1 adrenoceptor agonist
15986775|NCT02987465|Drug|BQ 123|BQ 123 is being used as a challenge agent in this study and is an (Endothelin A) ETA receptor agonist.
15986776|NCT02987452|Other|aerobic exercise|Aerobic exercise (EA): activity on a treadmill lasting 45 minutes with intensity of 50-60% of maximum heart rate (HR) obtained from ergometer test
15986777|NCT02987452|Other|resistance exercise|resistance exercise (RE): 4 series of 12 repetitions of resistance exercises at moderate intensity (until moderate fatigue), for 45 minutes
15987212|NCT02984150|Dietary Supplement|saline|
15986778|NCT02987452|Other|combined exercise|combined exercise (CE): EA (25 minutes) + ER (20 minutes), with an interval of 2 minutes between sessions totalizing 45 minutes
15986779|NCT02987439|Other|Pulmonary rehabilitation|The intervention is pulmonary rehabilitation
15986780|NCT02987426|Behavioral|Mindfulness-oriented intervention|"The 10 minutes daily sessions every weekday, will take place at the inpatient unit in groups of 10 people. The intervention will be alternating between three forms of moving mindfulness-oriented interventions as detailed below:
~Seated Tai Chi: patients will slowly move their arms in soft movements coordinated with slow breaths Gentle stretching: patients will slowly stretch their bodies coordinated with the breath and with awareness of physical sensations throughout the body4 Walking meditation: patients will walk slowly in no particular direction, focusing close attention on the act of walking"
15986781|NCT02987413|Biological|Autologous Mesenchymal stem cells (MSCs)|2 intrathecal autologous MSCs infusions (1x10^8 cells) will be performed, escalated from 30 days apart
15986782|NCT02987400|Drug|Venetoclax|3 cycles followed by 9 cycles consolidation if not transplant eligible
15986783|NCT02987400|Drug|Obinutuzumab|3 cycles followed by 9 cycles consolidation if not transplant eligible
15986784|NCT02987387|Device|SAPIEN XT THV|SAPIEN XT THV will be implanted in the pulmonic position.
15986785|NCT02987374|Biological|2011-2012 Fluzone IIV3 (IM)|2011-2012 Fluzone IIV3 vaccine delivered intramuscularly (IM)
15986786|NCT02987361|Device|DC-STIMULATOR PLUS|2mA for 20minutes a day, 5 days per weeks, totally 2 weeks
15986787|NCT02987348|Drug|exenatide once weekly|patients received exenatide once weekly treatment under their standard care, no intervention was given by the study investigator
15986788|NCT02987348|Drug|exenatide twice daily|patients with exenatide twice daily treatment under their standard care, no intervention was given by the study investigator.
15986789|NCT02987348|Drug|basal insulin|patients with basal insulin treatment under their standard care, no intervention was given by the study investigator
15986790|NCT02987335|Drug|Pancreatic Clamp|We are not performing any interventions; we are only characterizing participants using tests. The hormones that we are administering are not a treatment but are typically used in context of routine care.
15986791|NCT02987322|Dietary Supplement|honey|Ziziphus honey (sider honey) orally in a dose of 1ml (1.2g)/kg/day for 3 months
15986792|NCT02987296|Dietary Supplement|Immunonutrition with arginine|Nutritional beverage containing supplemental arginine taken 3 times per day
15986793|NCT02987296|Dietary Supplement|Immunonutrition without Arginine|Nutritional beverage without supplemental arginine taken 3 times per day
15986794|NCT02987270|Drug|Dihydroartemisinin-piperaquine|Dihydroartemisinin-piperaquine is an antimalarial in the artemisinin-based combination therapy class of drugs. It is the Kenya Ministry of Health second-line treatment for malaria in Kenya.
15986795|NCT02987257|Drug|Harmonized supportive care|Harmonized supportive care with placebo cyclosporine days 0-14 and etanercept placebo days 0 and 3
15986796|NCT02987257|Drug|Cyclosporine 5 mg/kg bid days 0-14|Harmonized supportive care with placebo etanercept days 0 and 3
15986797|NCT02987257|Drug|Etanercept 50 mg sc day 0 and day 3|Harmonized supportive care with placebo cyclosporine days 0-14
15986798|NCT02987244|Drug|Chidamide|"Six cycles of therapy will be administered,and each cycle of treatment is 28 days.
~Phase I: Patients were treated at the following dose levels: 15, 20, and 25 mg twice per week to determine the MDT Phase II: If MTD was not reached at 25mg dose level of Chidamide. The followed study will use 20mg twice per week as experimental dose."
15986799|NCT02987244|Drug|Cyclophosphamide|Cyclophosphamide(750mg/m2) was administered intravenously on d1
15986800|NCT02987244|Drug|Epirubicin|epirubicin (70mg/m2)was administered intravenously on d1;
15986801|NCT02987244|Drug|Vindesine|vindesine (4mg)was administered intravenously on d1;
15986802|NCT02987244|Drug|Etoposide|etoposide (100mg) was administered intravenously on d1,2,3.
15986803|NCT02987244|Drug|Prednisone|prednisone (60mg/m2)was administered intravenously by oral d1-5.
15986804|NCT02987231|Procedure|CAF|Periodontal plastic surgery for root coverage by the trapezoidal flap
15986805|NCT02987231|Device|ES|Local electric stimulation for 120 seconds, once a day for a week
15986806|NCT02987231|Device|SHAM|Simulation of electric stimulation protocol. In Sham stimulation non current will be applied
15986807|NCT02987218|Drug|Propofol|Intravenous hypnotic agent Decrease Cerebral Metabolic reduction Decrease ICP Better cognitive Function preservation
15986808|NCT02987218|Drug|Desflurane|Inhalational agent. Decreases cerebral metabolism Increase /decreases ICP Cognition preservation
15986809|NCT02987205|Device|Revanesse Ultra|NLF correction
15986810|NCT02987205|Device|Restylane|NLF Correction
15986811|NCT02987192|Device|pen type 27 gauge needles|minimally invasive group patients will receive pen type 27 gauge needles.
15986812|NCT02987192|Device|cutting type 22 gauge needles|traditional group patients will receive cutting type 22 gauge needles.
15986813|NCT02987179|Other|Observational|Collect anthropomorphic, WatchPAT, Crit-line Monitor measurements as well as sleep questionnaires and video records
15986814|NCT02987166|Radiation|High-Dose Conformal Radiation Therapy|"24 Gy in 3 fractions of 8Gy each for bone and/or soft tissue lesions
~30 Gy in 5 fractions of 6 Gy each for prostate gland"
15986815|NCT02987166|Drug|Pembrolizumab|200 mg
15986816|NCT02987153|Radiation|Kypho-IORT|The radiation source is inserted into the lesion and switched on for a few minutes to provide intraoperative radiotherapy accurately targeted to the tissues that are at the highest risk of local recurrence. The dosimetric characteristics and clinical applications of this device have been well studied.
15986817|NCT02987140|Behavioral|Clinical evaluations|Participants will receive clinical evaluations, and practice the finger sequence task used to assess context-dependency along with EEG assessment. On the second day, the participants will receive the TMS assessment.
15986818|NCT02987114|Drug|PLT101|PTL 101 (Cannabidiol, CBD) Two piece hard capsules filled with seamless gelatin matrix green beads containing CBD (50 or 100 mg CBD per capsule) The beads should be administered following a meal, mixed with food
15986819|NCT02987101|Procedure|Liposuction|Adipose tissue is harvested by liposuction from either abdomen or thighs.
15986820|NCT02987101|Other|Standard wound care|Patients will receive standard wound care and dressings independent of their participation in this study at the discretion of the wound nurses.
15986824|NCT02987075|Other|Non- compacting embryo transferring|transfer of 2 utilizable non-compacting embryos have 7-9 cells with under 20% fragmentation.
15986825|NCT02987036|Device|Aerogen|Two doses of aerosolized Albuterol sulfate (2.5 mg dissolved in saline) At study start (T l 0) and after 6 hours (Tll0) by mesh nebulizer
15986826|NCT02987036|Device|Jet nebulizer|Two doses of aerosolized Albuterol sulfate (2.5 mg dissolved in saline) At study start (T l 0) and after 6 hours (Tll0) by Jet nebulizer
15986827|NCT02987023|Procedure|uterus transplantation|Uterus transplantation from live donor
15986828|NCT02987010|Drug|IDH305|Isocitrate Dehydrogenase 1 inhibitor
15986829|NCT02986984|Other|There is no intervention|There are no interventions
15986830|NCT02986971|Device|New IMD|The contraceptive implants of the subjects in this arm are removed by the new IMD.
15986831|NCT02986958|Other|Pre-visit patient-family agenda-setting checklist|Pre-visit patient-family agenda-setting checklist
15986832|NCT02986958|Other|Usual care|routine primary care
15986833|NCT02986945|Behavioral|Resiliency App|
15986834|NCT02986932|Device|BBB opening|Open BBB using ExAblate focused ultrasound and (Definity®) contrast agent
15986835|NCT02986919|Drug|CPI-0610|"Optional tumor biopsy will be obtained prior to Day 1 of CPI-0610 administration.
~CPI-0610 will be administered 200mg orally once a daily for 14 consecutive days followed by a 7-day break. The 14 days of CPI-0610 dosing and the 7-day break together constitute 1 cycle of treatment. The dose will not be adjusted for body weight or body surface area."
15986836|NCT02986906|Drug|5% dextrose|Ultrasound-guided 5cc 5% dextrose injection between medial epicondyle and ulnar nerve
15986837|NCT02986906|Drug|2cc 0.9% normal saline+3cc Triamcinolone (30mg)|Ultrasound-guided 2cc 0.9% normal saline+3cc Triamcinolone (30mg) injection between medial epicondyle and ulnar nerve
15986838|NCT02986906|Device|Ultrasound|The ultrasound was used for injection guidance
15986839|NCT02986893|Behavioral|Dietary Intervention|Participants will be assigned to follow a specific diet for 6 months. This will involve meetings with the study nutritionist at least monthly as well as regular assessments related to adherence and effects.
15986840|NCT02986893|Behavioral|Non-dietary Intervention Arm|Participants will be requested to follow their usual diet and attend monthly meetings at the MS center to discuss various topics with a focus on wellness in MS for 6 months.
15986841|NCT02986880|Drug|Botulinum toxin A|
15986842|NCT02986880|Procedure|Placebo|Injection of sodium chloride (NaCl) 9/1000
15986843|NCT02986867|Radiation|SAbR Treatment of Lesions|"SAbR will be administered as per the guidelines of UTSW with a single 24-27Gy or three 10-14 Gy/fraction fractions totaling 33-48Gy. Lesions receiving SAbR will be called radiated lesions."
15986844|NCT02986854|Biological|Meningococcal (groups A, C, W and Y) oligosaccharide diphtheria CRM-197 conjugate Vaccine (Menveo)|One intramuscular injection of MenACWY at Day 1.
15986845|NCT02986828|Drug|platelet rich plasma|Ultrasound-guided 3cc PRP injection between proximal carpal tunnel and median nerve.
15986846|NCT02986828|Drug|Normal saline|Ultrasound-guided 3cc normal saline injection between proximal carpal tunnel and median nerve.
15986847|NCT02986828|Device|Ultrasound|
15986848|NCT02986815|Other|[11C]Acetate Brain Imaging|Patients will be imaged on a Siemens Biograph 64 slice PET CT scanner. After placing the patient on the scanner and securing the head in a head restraint, a low dose CT of the brain will be acquired. Images with 3 mm slice thickness and spaced at 1.5 mm intervals will be reconstructed in a 300 mm field of view. The purpose of the CT is for image localization and attenuation correction and it is not considered to be a diagnostic quality CT. Following the completion of the CT, the [11C]Acetate will be administered. A dynamic PET image will be acquired in 3D list mode for a total of 30 minutes.
15986849|NCT02986776|Behavioral|Inpatient Care|21 days of inpatient substance misuse treatment
15986850|NCT02986776|Behavioral|Outpatient Care|21 days of outpatient substance misuse treatment
15986851|NCT02986763|Biological|Questionnaire, blood, urine, hair and dust samplings|
15986852|NCT02986750|Device|Thealoz Duo Eye Drops|Manufacturer: Laboratoires Thea, France
15986853|NCT02986750|Device|Optive Eye Drops|Manufacturer: Allergan Pharmaceuticals, Ireland
15986854|NCT02986750|Device|Systane Ultra Eye Drops|Manufacturer: Alcon Pharma GmbH
15986855|NCT02986737|Device|ACURATE neo™ and ACURATE TA™ LP|ACURATE neo™ Aortic Bioprosthesis and ACURATE TA™ LP Transapical Delivery System on patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open-heart surgery is considered to be high risk
15986856|NCT02986711|Behavioral|Motivational Text Messages|Motivational text messages in addition to survey questions about smoking status
15986857|NCT02986711|Behavioral|Control|Only survey questions about smoking status
15986858|NCT02986698|Biological|in utero hematopoietic stem cell transplantation|This is a phase 1 safety study to demonstrate it is safe for both the mother and fetus to perform In utero hematopoietic stem cell transplantation of maternal derived stem cells at the time of intrauterine transplantation of red blood cells to treat fetuses affected with alpha-thalassemia major.
15986859|NCT02986685|Drug|Trimebutine Maleate|Rabeprazole 20mg once daily was administered during the 8 weeks' screening stage ,then oral trimebutine maleate 200mg three times daily combined with rabeprazole 20mg once daily were administered to the experimental arm for 4 weeks.
15986860|NCT02986685|Drug|rabeprazole|Rabeprazole 20mg once daily was administered during the 8 weeks' screening stage,and rabeprazole 20mg once daily was administered to other arm for additional 4 weeks.
15986861|NCT02986672|Dietary Supplement|Calanus oil|Omega-3 oil in form of calanus oil
15986862|NCT02986672|Other|Medical Paraffin|2ml per day
15986863|NCT02986659|Drug|Metformin|
15986864|NCT02986659|Drug|Placebo|
15986865|NCT02986633|Other|Echocardiography|
15986866|NCT02986620|Genetic|IDH mutation test performed at diagnosis or relapse until January 31st, 2019.|Observation of the test result.
15986867|NCT02986607|Drug|parathyroid hormon 1-84|Hypoparathyroidism patients will receive Natpara in continous subcutaneous infusion delivered by a pump for 4-7 days.
15986868|NCT02986594|Drug|Aspirin|
15986869|NCT02986594|Drug|Heparin|
15986900|NCT02986347|Procedure|Intravenous regional anesthesia (Bier)|Intravenous regional anesthesia (Bier Technique)
15986901|NCT02986347|Procedure|Local anesthesia with adrenaline|local anesthesia with adrenaline without limber garroting (Lalonde Technique)
15986870|NCT02986568|Procedure|Cervical cancer|"If tumor sized ≥ 5cm, undergo neoadjuvant chemotherapy with Cisplatin before surgery. (40mg/m2 on day 1 of each 7 day cycle for 5 cycles), then perform Fusion TMMR after neoadjuvant chemotherapy with cisplatin as above.
~If tumor size < 5cm, perform Fusion Total mesometrial resection (TMMR)
~After surgery, if resection margin, more than two pelvic lymph node or more than one para-aortic lymph node is positive in pathologic report, undergo adjuvant chemotherapy.
~If not, no adjuvant therapy."
15986871|NCT02986568|Procedure|Uterine cancer|"Perform Fusion Peritoneal mesometrial resection (PMMR).
~After surgery, if resection margin, more than two pelvic lymph node or more than one para-aortic lymph node is positive in pathologic report, undergo adjuvant chemotherapy.
~If not, no adjuvant therapy."
15986872|NCT02986568|Procedure|Cervical cancer, pelvic sidewall invasion|"Perform Fusion Laterally extended endopelvic resection (LEER).
~After surgery, if resection margin, more than two pelvic lymph node or more than one para-aortic lymph node is positive in pathologic report, undergo adjuvant chemotherapy. Patients with primary disease will be treated with adjvuant chemotherapy. In case of recurrent disease, bevacizumab, paclitaxel, and cisplaitn will be administered regardless of the pathologic report (bevacizumab 15mg/kg on day 1, paclitaxel 135mg/m2 on day 1, and cisplatin 50mg/m2 on day 2, of each 21 day cycle).
~If not, no adjuvant therapy."
15986873|NCT02986568|Procedure|Non-cervical cancer, pelvic sidewall invasion|"Perform Fusion Laterally extended endopelvic resection (LEER).
~After surgery, appropriate adjuvant chemotherapy will be administered depending on the tumor type."
15986874|NCT02986555|Device|Existing Biofeedback|Using relaxing assisted biofeedback approach
15986875|NCT02986555|Device|Biofeedback accompanied with virtual reality|Using relaxation approach with existing biofeedback accompanied by virtual reality relaxation
15986876|NCT02986542|Procedure|Femoral artery catheterization|The intervention will be performed by a single experienced individual.
15986877|NCT02986529|Drug|GV-971|
15986878|NCT02986529|Drug|Placebos|
15986879|NCT02986516|Other|Randomized Cohort|Surgical treatment with different approach, based on the characteristics of the tumor or definitive high dose radiotherapy (carbon ion radiotherapy, proton-therapy, mixed photons-proton therapy) will be assigned by randomization
15986880|NCT02986516|Radiation|Prospective cohort|Surgical treatment or definitive high dose radiotherapy will be selected by the patients and will be prospectively evaluated
15986881|NCT02986503|Drug|Doxorubicin+cisplatin+ifosfamide|Chemotherapy for Good responder high grade osteosarcoma
15986882|NCT02986503|Drug|Doxorubicin+cisplatin+ifosfamide+methotrexate|Chemotherapy for Poor responder high grade osteosarcoma
15986883|NCT02986490|Biological|Blood sample|Blood sample
15986884|NCT02986477|Other|Contrast Ultrasound|For diagnostic purposes, intravesicle administration of contrast ultrasound agent will be performed to study vesicoureteral reflux.
15986885|NCT02986464|Device|Virtual Reality Prototype|VR prototype installed around the tank in the hydrotherapy room to give the child a sense of immersion in the virtual world with a possibility of interaction depending on the child's age and condition.
15986886|NCT02986464|Other|Standard Pharmacological Treatment|According to the unit's protocol and adjusted to each participant's age, weight and condition by the anesthetist and the pain clinic nurse.
15986887|NCT02986451|Drug|clarithromycin|Clarithromycin 500mg PO twice daily on days 1-28 for a 28-day cycle.
15986888|NCT02986451|Drug|Lenalidomide|Lenalidomide 25mg PO daily on days 1-21 of a 28-day cycle
15986889|NCT02986451|Drug|Dexamethasone|Dexamethasone 40mg PO will be given on days 1, 8, 15, 22 of a 28-day cycle.
15986890|NCT02986438|Device|Repetitive Transcranial Magnetic Stimulation|"The investigators will use a Magpro R-30 MagVenture quick stimulator, equipped with an 8-reel, 75 mm internal diameter in each spiral.
~Each patient will receive consistent treatment in 2 sessions a day for 10 consecutive business days in the first two weeks, then receive 2 weekly sessions, until the year of treatment is completed. Each session will consist of the application of 30 trains of 10 seconds duration separated by intervals of one minute, at a fixed frequency (5Hz or 10Hz), to 100% of the motor threshold."
15986891|NCT02986438|Device|Repetitive Transcranial Magnetic Stimulation (Sham)|"The investigators will use a Magpro R-30 MagVenture quick stimulator, equipped with an 8-reel, 75 mm internal diameter in each spiral with a coil that allows simulated stimulation (Coil AP).
~This condition will only last two weeks."
15986892|NCT02986425|Other|STRIP intervention|"The STRIP intervention consists of 9 steps:
~structured history taking of medication
~recording medication and diagnoses in STRIPA
~structured drug review based on the STRIPA with the integrated Screening Tool of Older Person's Prescriptions (STOPP)/ Screening Tool to Alert Doctors to the Right Treatment (START) criteria
~communication and discussion of the structured drug review with prescribing physician with possible adaptation of the recommendation
~shared decision-making with the patient with possible adaptation of the recommendation
~optional revision based on new accumulating data during hospitalisation (e.g. new diagnoses, adverse drug reactions)
~generation of general practioner (GP) report
~delivery of the report to the patient and to the GP (optional additional direct communication)
~follow-up"
15986893|NCT02986425|Other|Control|Standard care in the department where the trial is conducted. To keep the patients and the blinded team members blinded one questionnaire will be conducted by the intervention team in both arms. This is considered a SHAM intervention.
15986894|NCT02986412|Other|CG428|The experimental group will receive CG428. For each application, the patient should shake the bottle before spraying 10-12 times directly to the dry scalp whole area, with the nozzle, and then gently massage the whole scalp with fingertips in order to spread the lotion evenly until it has completely penetrated the scalp. Hairs should not be washed or shampooed within 1 hour following study treatment administration. Each dose should be spaced out by minimum 4 hours.
15986895|NCT02986399|Other|Fast track patient pathway|Admittance: Ambulance - Radiology - Orthopaedic ward. Focus on preoperative information, stress reduction, pain relief, early mobilization and nutritional status.
15986896|NCT02986386|Procedure|Dental occlusion restoration|Placement of dental implants by surgical intervention followed, after a healing period of 2 months, by fabrication and installation of implant supported dental prosthesis
15986897|NCT02986386|Procedure|Orthodontic treatment of malocclusion|Orthodontic therapy to treat malocclusion
15986898|NCT02986373|Biological|risankizumab|Risankizumab administered by subcutaneous injection.
15986899|NCT02986360|Behavioral|Vidscrip educational video|Vidscrip educational video provide to women
15986902|NCT02986334|Drug|Naproxen|Subjects enrolled in the active treatment arm will receive 500mg of Naproxen prescribed twice daily, once in the morning and evening.
15986903|NCT02986334|Drug|Omeprazole|Subjects enrolled in the active treatment arm will receive 20mg of Omeprazole prescribed twice daily, once in the morning and evening. Furthermore, subjects should take this one hour before a meal.
15986904|NCT02986334|Drug|Placebo|Subjects enrolled in the inactive treatment arm will receive two prescriptions, however, there are no active ingredients and are intended to look identical to the active treatment. Therefore, subjects will be instructed exactly the same way as if they were ingesting the active treatment.
15986905|NCT02986321|Drug|CHF6001|Dose response: Test one of 4 different doses of CHF6001
15986906|NCT02986321|Drug|Budesonide|active control
15986907|NCT02986321|Drug|Placebo|placebo control
15986908|NCT02986308|Other|No intervention|
15986909|NCT02986295|Device|BioMimeTM Stent, Ultimaster® Stent|
15986910|NCT02986282|Device|ABI measurement using both doppler and oscillometric method|
15986911|NCT02986269|Procedure|general anesthesia across LMA|general anesthesia across LMA
15986912|NCT02986269|Procedure|Spontaneous breathing(SB)|general anesthesia across LMA under SB without PSV
15986913|NCT02986269|Procedure|Pressure Support Ventilation|general anesthesia across LMA under SB with PSV
15986914|NCT02986256|Behavioral|Taking pictures|Photograph of foot ulcer with transmission to referring nurse 1 time per week
15986915|NCT02986256|Behavioral|Visit at home|Home visit by the referring nurse every 15 days
15986916|NCT02986243|Other|Exercise|6 months worth of exercise regimen
15986917|NCT02986243|Dietary Supplement|Diet Plan|Each subject will receive a personalized diet plan from nutritionist.
15986918|NCT02986230|Other|Cancer prevention wizard (CPW)|The cancer prevention wizard is a point of care clinical decision support system designed to identify patients that are due for preventative cancer services and provides evidenced-based recommendations to the patient and provider.
15986919|NCT02986217|Other|regular structured assessment of surgical performance|
15986920|NCT02986204|Procedure|removal of ENG implant|"the researcher(s) will ask you to: Visit 1 - SCREENING VISIT
~questions about your medical/contraception history
~Review medical record
~physical examination
~urine sample for pregnancy test
~Visit 2a - Radiology
~Have an ultrasound of your arm
~The radiologist will mark your arm at the location of the implant.
~Visit 2b
~ultrasound of your arm to locate the implant. This is done by feeling the area.
~Have your ENG implant removed through a numbed small cut. The researcher will apply a pressure bandage to the site(s). This will reduce bleeding/decrease swelling.
~Have the removal procedure video recorded.
~Visit 3 - FOLLOW UP VISIT approximately 2 weeks after Visit 2:
~Provide a urine sample for pregnancy test
~Have the implant removal site examined"
15986921|NCT02986204|Procedure|continuation of ING implant|"the researcher(s) will ask you to:
~To answer questions about your medical and contraception history
~Review your medical record
~Have a physical examination by the researcher
~Provide a urine sample for pregnancy test
~Have an ultrasound of your arm"
15986922|NCT02986191|Procedure|Mucograft|This method of grafting will be used to treat the gingival recession using coronally advanced flaps.
15986923|NCT02986191|Procedure|Connective Tissue Graft|This will be used in the traditional manner to correct gingival recession
15986924|NCT02986178|Biological|PVSRIPO|A single dose of an oncolytic polio/rhinovirus recombinant (PVSRIPO)
15986925|NCT02986165|Dietary Supplement|Placebo control|The placebo control is water containing a commercially available orange flavoured powder (Kool aid) which will be diluted according to the manufacturer's instructions
15986926|NCT02986165|Dietary Supplement|Low dose pomace extract|Immediately prior to ingestion, 'drinks' containing 1 g of tomato pomace extract will be prepared at the research facility. The water used to dilute the extract will be flavoured using a commercially available orange flavoured powder (Kool aid) which will be diluted according to the manufacturer's instructions before adding to the tomato pomace extract.
15986927|NCT02986165|Dietary Supplement|High dose pomace extract|Immediately prior to ingestion, 'drinks' containing 2.5 g of tomato pomace extract will be prepared at the research facility. The water used to dilute the extract will be flavoured using a commercially available orange flavoured powder (Kool aid) which will be diluted according to the manufacturer's instructions before adding to the tomato pomace extract.
15986928|NCT02986152|Behavioral|Cancer Distress Coach Mobile App|"Cancer Distress Coach is a stand-alone symptom management tool with three basic components. The Learn about Distress module provides psycho-education. The Insights module includes an inspiring Quote of the Day, daily activity planning tips, a graph displaying the user's distress level plotted over time, and assessment feedback. The main action of the application is in the Activities module that provides patients with skills to manage their stress in the moment they experience it. Depending on the severity, the patient is routed to any of a number of helpful skills based on cognitive-behavioral principles. The stress management tools include positive imageries, soothing songs and pictures, and the Relax-Identify-Decide tool. Also included is find support and get support now to connect the user to his/her support network and locate informal cancer and non-cancer related support or (immediate) professional care."
15986929|NCT02986139|Drug|Commercial Formulation Etanercept|Etanercept was supplied in a single-use SureClick autoinjector as a sterile, preservative-free solution for SC injection containing 0.98 mL of 50 mg/mL etanercept in the commercial formulation.
15986930|NCT02986139|Drug|New Formulation Etanercept|Etanercept was supplied in a single-use SureClick autoinjector as a sterile, preservative-free solution for SC injection containing 0.98 mL of 50 mg/mL etanercept in the new formulation.
15986931|NCT02986126|Behavioral|Resiliency Class|See Arm Description
15986932|NCT02986126|Other|Resource for Services (RS)|See Resource for Services (RS) Description
15986933|NCT02986113|Behavioral|MAPS tailored multimedia patient activation program|
15986934|NCT02986113|Behavioral|Sleep hygiene video|3 minute video on sleep hygiene produced by HealthiNation
15986935|NCT02986113|Behavioral|Telephone evidence-based follow-up care|3 months of suicide-focused collaborative mental health care, directed by a supervising psychiatrist and implemented by a care manager working with the patient and their primary care provider
15986936|NCT02986113|Behavioral|Commitment to Living for Primary Care|Brief (30 minutes total time) video modules presenting participating patients' primary care providers with a patient-centered framework for suicide risk assessment and intervention
15986937|NCT02986100|Drug|C-14 labeled Rucaparib|Each dosage unit consists of a hard gelatin capsule filled with cold rucaparib camsylate and [14C]-rucaparib camsylate salt. Each capsule contains approximately 150 mg rucaparib (free base weight) and approximately 35 µCi of [14C]-rucaparib. Each patient will ingest four capsules in the fasted state for a total dose of 600 mg rucaparib (free base weight) with approximately 140 µCi of [14C]-rucaparib
15986938|NCT02986100|Drug|Rucaparib|200 & 300 mg tablet
15986939|NCT02986087|Device|Fetal Tracheal Occlusion|Fetuses with congenital diaphragmatic hernia with an observed to expected lung-to-head ratio of <25%, LHR <1, o/e LHR<30% (moderate), singleton pregnancy, no known other anomalies, gestational age < 29 weeks 6 days, no maternal disease, maternal age > 18 years old meet criteria to be offered tracheal occlusion. We want to test feasibility and efficacy in our center as a requirement to enter the TOTAL trial.
15986940|NCT02986074|Device|Paresthesia mapping lead evaluation first|Subjects will evaluate the clinical efficacy of stimulation delivered using the lead implanted using paresthesia mapping in the first part of the SCS trial and using the lead implanted using anatomical midline placement in the second part of the SCS trial
15986941|NCT02986074|Device|Anatomical midline lead evaluation first|Subjects will evaluate the clinical efficacy of stimulation delivered using the lead implanted using anatomical midline in the first part of the SCS trial and using the lead implanted using paresthesia mapping placement in the second part of the SCS trial
15986942|NCT02986061|Device|Urinary catheter|
15986943|NCT02986048|Other|Proton Beam Therapy|Intervention is not assigned. Only patient data is being collected
15986944|NCT02986035|Other|ECA cream|
15986945|NCT02986022|Behavioral|Resilience|Self-efficacy, optimism, altruism, goal setting
15986946|NCT02986022|Behavioral|Information|Information and resources about education, medical care, housing, employment, and community facilities available in Hong Kong and Mainland China
15986947|NCT02986009|Behavioral|Parenting|"The parenting intervention consists of four weekly sessions, each lasting two hours. The intervention was designed according to the parenting characteristics of Chinese parents in Hong Kong. The four sessions cover: 1) response modification (stop and rest), 2) relaxation/enhancing positive moods (relax and play), 3) cognitive reframing (think), and 4) using social support (talk and share). Discussion, practice, and questions are involved in each session."
15986948|NCT02986009|Behavioral|Information|The information intervention consists of four weekly sessions, each lasting for two hours. The contents cover information and resources about education, medical care, housing, employment, and community facilities available in Hong Kong and Mainland China.
15986949|NCT02985996|Drug|Truvada|Truvada is intended for the treatment of HIV-1 infection. Truvada is a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg in one tablet.
15986950|NCT02985996|Drug|Genvoya|Genvoya is a 1-pill, once-a-day prescription medicine used to treat HIV-1. Genvoya is a combination of 150 mg of elvitegravir, 150 mg of cobicistat, 200 mg of emtricitabine, and 10 mg of tenofovir alafenamid in one tablet.
15986951|NCT02985983|Drug|KHK4827|Administered KHK4827 by subcutaneous (SC) injection until week 66.
15986952|NCT02985983|Drug|Placebo|Administered Placebo by subcutaneous (SC) injection until week 16. Administered KHK4827 by SC injection from week 17 until week 66.
15986953|NCT02985970|Other|questionnaire|The questionnaire will be send to all members of ČSARIM with the selected 4 controversial clinical scenarios in which the RSI should be used
15986958|NCT02985944|Procedure|Colonoscopy|Colonoscopy performed in adult consecutive patients for different indications
15986959|NCT02985931|Other|Diagnostic imaging scans of SPECT and MRI|
15986960|NCT02985918|Device|High-intensity NPPV|The patients will receive noninvasive positive pressure ventilation using S/T mode. The inspiratory positive airway pressure will be initially set at 10 cmH2O, and will be continuously adjusted by increments/decrements of 1-2 cmH2O, according to subjects' tolerance (up to 30 cmH2O), to obtain a VT of 15 mL/kg of predicted body weight, and to achieve normocapnia as possible as it can.
15986961|NCT02985918|Device|Conventional-intensity NPPV|The patients will receive noninvasive positive pressure ventilation using S/T mode. The inspiratory positive airway pressure will be initially set at 10 cmH2O, and will be continuously adjusted by increments/decrements of 1-2 cmH2O, according to subjects' tolerance (up to 20 cmH2O), to obtain a VT of 10 mL/kg of predicted body weight.
15986962|NCT02985905|Dietary Supplement|zinc sulfate|The subfertile group treated with zinc sulfate, every participant took two capsules of zinc sulfate per day for three months (each one 220 mg).
15986963|NCT02985892|Other|SSASG|"Both groups will perform segmental stabilization exercises (SS), which emphasis is for the lumbar multifidus muscles (ML) and transversus abdominis (TAR), using protocol proposed by Richardson et al. Four types of exercises will be carried out with four sets of ten exercises. Muscle contractions will be held for ten seconds and followed by ten seconds rest. Between each type of exercise patients will rest for one-minute interval.
~Patients of segmental stabilization active stretching group (SSASG) will perform stretch exercises in four sets of 30 seconds for each muscle. The active stretching exercises will last 15 minutes. The muscles that will be stretched are pectorals, latissimus dorsi, latissimus dorsi, teres major, rectus abdominis, external and internal oblique."
15986964|NCT02985892|Other|SSPSG|"Both groups will perform segmental stabilization exercises (SS), which emphasis is for the lumbar multifidus muscles (ML) and transversus abdominis (TAR), using protocol proposed by Richardson et al. Four types of exercises will be carried out with four sets of ten exercises. Muscle contractions will be held for ten seconds and followed by ten seconds rest. Between each type of exercise patients will rest for one-minute interval.
~Patients of segmental stabilization placebo stretching group (SSPSG) will perform exercises that simulate stretching, but the muscles will not suffer effective stretch. The placebo stretching exercises will last 15 minutes. The muscles that will be stretched are wrist flexors and extensors muscles and fingers flexors and extensors muscles."
15986965|NCT02985879|Drug|Placebo|Participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW >59 kg, 4.7 mL/min or 282 mL/hr.
15987048|NCT02985255|Drug|Docetaxel|Neoadjuvant Arm
15987049|NCT02985255|Drug|Cisplatin|Neoadjuvant Arm
15986966|NCT02985879|Drug|ABBV-8E12|Participants with 44-49 kg body weight (BW) had an intravenous infusion rate of 3.5 mL/min or 210 mL/hr; those with 50-58 kg BW, 4.0 mL/min or 240 mL/hr; and those with a BW >59 kg, 4.7 mL/min or 282 mL/hr. For participants in Cohort 2, ABBV-8E12 doses may have been decreased after the evaluation by the Data Monitoring Committee of available safety, tolerability and pharmacokinetic data.
15986967|NCT02985866|Device|Artificial Pancreas|Use of CTR at home for 3 months
15986968|NCT02985866|Other|Sensor Augmented Therapy|Use of personal pump with study CGM & glucometer at home for 3 months
15986969|NCT02985840|Drug|Ondansetron|Patients receive intravenous ondansetron (4mg) followed by two 5ml normal saline flushes
15986970|NCT02985840|Drug|Dexamethasone|Patients receive intravenous ondansetron(4mg) followed by intravenous dexamethasone (4mg), followed by a single 5ml normal saline flush
15986971|NCT02985827|Drug|Rohto (r) Hydra|Rohto (r) Hydra; Over the counter Eyedrop, 1 gtt OU single-masked in-office dose
15986972|NCT02985827|Drug|Systane (r) Ultra|Systane (r) Ultra; Over the counter Eyedrop, 1 gtt OU single-masked in-office dose
15986973|NCT02985801|Drug|Pancrelipase|Lipase 16,000 United States Pharmacopoeia (USP) units, protease 57,500 USP units, and amylase 60,500 USP units
15986974|NCT02985801|Drug|Placebo Oral Capsule|Placebo Oral Capsule
15986975|NCT02985775|Biological|Donor-derived CMVpp65-specific T cells|About 1 million per kg CMVpp65-specific T cells will be infused once acute GVHD ocurred post haploidentical transplantation.
15986976|NCT02985762|Drug|EXPAREL|
15986977|NCT02985749|Drug|Intranasal Oxytocin|This study is examining the short-term efficacy and tolerability of intranasal oxytocin for the treatment of social impairment in youths and adults with high-functioning ASD (HF-ASD).
15986978|NCT02985736|Drug|Topicort Topical Spray|
15986979|NCT02985723|Device|AT LISA tri toric 939MP|
15986980|NCT02985710|Device|Sudoscan|The Sudoscan is a non invasive procedure and similar to standing on a scale to be weighed. Sudoscan measurements are made in compliance with the manufacturer's recommended procedures. The measurement is rapid and non-invasive, and requires no advance preparation.
15986981|NCT02985710|Procedure|Skin biopsy|For subjects that give additional consent, skin biopsy will be done in standard fashion under sterile conditions. Assessment of nerve fiber density typically involves a 3-mm punch biopsy of skin from the leg (10 cm above the external malleolus).
15986982|NCT02985710|Procedure|QSART|QSRT (quantitative sudomotor axon reflex test) testing involves having a technician wipe the subject's arms and leg with alcohol, then tissue to wipe it dry. Electrodes filled with acetylcholine are put on three areas of the leg and one on the wrist, stimulators are turned on and sweat responses are measured.
15986983|NCT02985697|Drug|Dexmedetomidine|The intervention being tested is intranasal dexmedetomidine
15986984|NCT02985697|Drug|Midazolam Hydrochloride|Oral midazolam is being used as the Active Comparator. It will also be used in conjunction with IN dexmedetomidine in some experimental groups.
15986985|NCT02985697|Drug|Nitrous Oxide|Nitrous oxide to be administered in conjunction with other interventions, per study design.
15986986|NCT02985684|Device|GORE® CARDIOFORM ASD Occluder|Percutaneous Atrial Septal Defect Closure
15986987|NCT02985671|Drug|orphenadrine, acetaminophen, caffeine and diclofenac sodium|orphenadrine 35mg, acetaminophen 325mg, caffeine 65mg and diclofenac sodium 50mg tablet
15986988|NCT02985671|Drug|Diclofenac Sodium 50 MG|Voltaren (diclofenac sodium 50mg) tablet
15986989|NCT02985671|Drug|Placebo (for experimental drug)|tablet without active substances, manufactured to mimic experimental product tablet
15986990|NCT02985671|Drug|Placebo (for Voltaren)|tablet without active substances, manufactured to mimic Voltaren 50mg tablet
15986991|NCT02985658|Drug|Veliparib|"Patients will start veliparib at 300 mg po BID days 1 through 21 of the first 21 day cycle, then increase to 400 mg po BID days 1 through 21 of each subsequent cycle, as tolerated by the patient.
~At the treating investigator's discretion, and with principal investigator approval, veliparib may be used in combination with cisplatin and/or vinorelbine. Veliparib (300mg) will be dosed po BID on Days 1 through 14 of each 21-day cycle.
~The patient will receive therapy as long as there is therapeutic benefit"
15986992|NCT02985658|Drug|Cisplatin|Cisplatin will be administered intravenously (75 mg/m2) on Day 1 of each cycle
15986993|NCT02985658|Drug|Vinorelbine|Vinorelbine will be administered intravenously on Day 1 and Day 8 of each 21-day cycle
15986994|NCT02985645|Procedure|maxillary sinus augmentation with CGF|Graftless maxillary sinus augmentation surgery with CGF application utilizing DIVA system
15986995|NCT02985645|Device|"dynamic implant valve approach - DIVA system"|The DIVA system will be used to apply the CGF to the maxillary sinus.
15986996|NCT02985632|Drug|BMS-986141|
15986997|NCT02985619|Drug|Bevacizumab|intravitreus injection of 0,05ml containing Bevacizumab (1,25mg/0,05ml)
15986998|NCT02985619|Drug|Triamcinolone Acetonide|intravitreus injection of 0,03ml containing Triamcinolone Acetonide (1,20 mg/0,03ml)
15986999|NCT02985606|Other|Caffeine powder -60|
15987000|NCT02985606|Other|Caffeine powder -30|
15987001|NCT02985606|Other|Caffeine powder 0|
15987002|NCT02985606|Other|Placebo powder -60|
15987003|NCT02985606|Other|Placebo powder -30|
15987004|NCT02985606|Other|Placebo powder 0|
15987005|NCT02985593|Drug|KHK4083|
15987006|NCT02985593|Drug|Placebo|
15987007|NCT02985580|Dietary Supplement|Blueberry|
15987008|NCT02985580|Dietary Supplement|Placebo|
15987009|NCT02985567|Other|Intraocular pressure evaluation|Intraocular pressure checked with Icare rebound tonometer at 25 minutes after induction, followed by every 10 minutes until sedation was complete.
15987010|NCT02985554|Drug|Nivolumab|Nivolumab dose escalation will be used for the intensification phase with starting dose at 1m/kg every 2 weeks for 4 doses.
15987011|NCT02985541|Drug|Levonorgestrel IUS (Mirena, BAY86-5028)|Levonorgestrel intrauterine delivery system (IUS) with an initial in vitro release rate of 20 μg Levonorgestrel per day
15987012|NCT02985528|Other|further diagnostic|further diagnostic procedures - mainly CHEST CT -
15987050|NCT02985255|Drug|5FU|Neoadjuvant Arm
15987051|NCT02985255|Radiation|Radiotherapy|Neoadjuvant Arm
15987052|NCT02985255|Procedure|Glossectomy|Neoadjuvant Arm
15987053|NCT02985242|Drug|Empagliflozin|Empagliflozin film-coated tablet
15987054|NCT02985242|Drug|Glimepiride|Glimepiride tablet
15987013|NCT02985515|Combination Product|Smell training|"Eligible participants will be provided with a NeilMed Sinus Rinse Regular Bottle Kit and a one-month supply of USP Grade Sodium Chloride & Sodium Bicarbonate Mixture commercially prepared packets. Participants will need to purchase distilled water or boil tap water for five minutes for use with the saline irrigation. The contents of two capsules (0.5mg budesonide each) will be dissolved into NeilMed Sinus Rinse Regular Bottle along with the saline rinse. Both nasal cavities will be irrigated once daily for 30 days.
~Participants who do not have objective improvement in their olfaction after the trial of budesonide irrigation will have a baseline resting-state fMRI (rs-fMRI) and undergo 12 weeks of smell training. Smell training involves the participants smelling 4 vials of essential odors twice a day for 12 weeks. Following smell training, participants will have their smell ability re-evaluated and a second rs-fMRI performed."
15987014|NCT02985502|Other|pancreatogenic diabetes|pancreatogenic diabetes
15987015|NCT02985489|Dietary Supplement|Olimel Parenteral Nutrition|Olimel 5.7% with electrolytes
15987016|NCT02985476|Other|Health reports|Participants were sent 3 sets of individualised, educationally enriched health reports about their diagnosed inflammatory bowel disease history, care plan and updates on their recent health status, results or encounters with health care services.
15987017|NCT02985450|Biological|Engerix-B|Hepatitis B Vaccine
15987018|NCT02985437|Drug|Surfactants|
15987019|NCT02985437|Drug|Saline Solution|
15987020|NCT02985424|Other|18F-FDG PET/CT|18F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography
15987021|NCT02985411|Behavioral|Immediate Gardening Intervention|Provided with supplies to plan/plant 3 vegetable gardens over the course of a year. Survivors will be paired with a master gardener from their local Cooperative Extension to help guide them and provide mentorship in vegetable gardening,
15987022|NCT02985411|Other|Delayed Gardening Intervention|Subjects will be monitored for 1-year and will then receive the same vegetable gardening intervention as described under the Immediate Gardening Intervention
15987023|NCT02985398|Biological|ALD403 (Eptinezumab)|
15987024|NCT02985385|Other|Palliative management|Diagnostic studies for abnormal fetal ultrasounds
15987025|NCT02985372|Drug|Decitabine|All patients were treated with decitabine of 15 mg/ m2 intravenously over 4h for 5 consecutive days (day 1-5) for priming combined with cytarabine of 10 mg/m2 q12h for 10 days (day 4-13).
15987026|NCT02985372|Drug|Cytarabine|
15987027|NCT02985359|Dietary Supplement|Nutributter|Daily 20g Nutributter provided to children 6 to 24 month of age
15987028|NCT02985359|Behavioral|Social Behavioral Change Communication (SBCC)|Social Behavioral Change Communication (SBCC) activity focused on improving infant and young child feeding (IYCF) practices and water, sanitation, and hygiene (WASH) behaviors through community groups.
15987029|NCT02985346|Biological|Bone marrow mesenchymal stem cells in treatment of Idiopathic pulmonary hemosiderosis|
15987030|NCT02985333|Drug|Paclitaxel|Paclitaxel 170 mg/m(2) IV over 3 h d1
15987031|NCT02985333|Drug|Cyclophosphamide|Cyclophosphamide 200mgmg/m(2) IV d1,3,5
15987032|NCT02985333|Drug|Dexamethasone|Dexamethasone 20mg iv d1-4
15987033|NCT02985320|Biological|Single-dose regimen of high dosage investigational sIPV|The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
15987034|NCT02985320|Biological|Single-dose regimen of medium dosage investigational sIPV|The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
15987035|NCT02985320|Biological|Three-dose regimen of high dosage investigational sIPV|The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
15987036|NCT02985320|Biological|Three-dose regimen of medium dosage investigational sIPV|The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
15987037|NCT02985320|Biological|Three-dose regimen of low dosage investigational sIPV|The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
15987038|NCT02985320|Biological|Three-dose regimen of commercialized sIPV|The control vaccine was manufactured by Chinese Academy of Medical Sciences.
15987039|NCT02985320|Biological|Three-dose regimen of commercialized IPV|The control vaccine was manufactured by Sanofi Pasteur S.A (IMOVAX POLIO).
15987040|NCT02985307|Behavioral|Short Message Text Service|A service designed by professionals inside the National Health Service (NHS) to provide support and advice for participants to manage weight loss. It combines the expertise of the healthcare team and the convenience of the participant's own mobile phone to give prompts and advice to act on. It makes use of the familiar and convenient mobile phone text service 'SMS' to communicate directly with participants.
15987041|NCT02985307|Behavioral|Standard Weight Management Group|A standard Lothian NHS group programme facilitated by a Dietitian
15987042|NCT02985294|Other|Multiple Excitability Measures of peripheral nerves|The technique of threshold tracking can be used to obtain several measures of peripheral nerve excitability (Multiple Excitability Measures or MEM), such as refractoriness, supernormality, strength-duration time constant and 'threshold electrotonus' (i.e. the changes in threshold produced by long-lasting depolarizing or hyperpolarizing current pulses). Each of these measurements depends on membrane potential and on other biophysical properties of the axons. Many of these excitability parameters are very constant among different subjects, while other, such as the current/threshold parameters and the super/sub-excitability parameters, appear to be characteristic of an individual
15987043|NCT02985281|Drug|Sofosbuvir Oral Product|direct acting antiviral drug for HCV infection
15987044|NCT02985281|Drug|Ribavirin|antiviral drug for HCV infection
15987045|NCT02985268|Device|MitraClip|The MitraClip Clip Delivery System is indicated for the percutaneous reduction of significant symptomatic mitral regurgitation (MR ≥ 3+) due to primary abnormality of the mitral apparatus [degenerative MR] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.
15987046|NCT02985268|Drug|Optimal Medical Therapy|Optimal medical therapy administered as per the Guideline Direct Medical Therapy (GDMT) as defined in the 2013 ACCF/AHA Heart Failure Guidelines with maximum tolerated doses of an ACE-inhibitor or Angiotensin Receptor Blocker (ARB) and beta-blocker
15987047|NCT02985268|Device|CRT-D|Cardiac Resynchronization Therapy with defibrillation therapy devices will be implanted according to the Heart Rhythm Society Guidelines for implanted devices.
15987057|NCT02985229|Drug|Mifepristone|The option of home or clinic administration of 200 mg oral mifepristone
15987058|NCT02985229|Drug|Misoprostol|800 μg buccal misoprostol through 70 days LMP following administration of mifepristone
15987059|NCT02985216|Drug|YHD1119|"YHD1119 150mg, PO YHD1119 300mg, PO
~YHD1119 600mg, PO"
15987060|NCT02985216|Drug|Lyrica|Lyrica 75mg, PO Lyrica 150mg, PO Lyrica 300mg, PO
15987061|NCT02985203|Drug|Vinorelbine Oral|Oral vinorelbine plus cisplatin Followed by Metronomic oral Vinorelbine
15987062|NCT02985190|Drug|Azacitidine|Azacitidine at 75mg/m²/j for 7 days.
15987063|NCT02985177|Drug|Fentanyl intranasal + Oral Hydromorphone|Analgesics
15987064|NCT02985177|Drug|Fentanyl intranasal + Oral ibuprofen|Analgesics
15987065|NCT02985164|Radiation|PDSa|After an anesthesiologist administered a narcotic and an induction agent to a patient (total intravenous anesthesia, TIVA), an endoscopist commenced the procedure. A co-researcher turned on Pocket Radiation Dosimeter label as PDSa1 (outside lead apron),PDSa2 (inside lead apron).
15987066|NCT02985164|Radiation|PDSb|After an anesthesiologist administered a narcotic and an induction agent to a patient (total intravenous anesthesia, TIVA), an endoscopist commenced the procedure. A co-researcher turned on Pocket Radiation Dosimeter label as PDSb1 (outside lead apron), PDSb2 (inside lead apron).
15987067|NCT02985151|Device|Syneron-Candela CO2RE Laser|This fractionated ablative laser will administer energy at either a high intensity setting or a low intensity setting to subjects randomized into a particular treatment group. It will be operated by the principle investigator, who has extensive experience with laser therapy.
15987068|NCT02985138|Procedure|TLIF and unilateral pedicle screw fixation|TLIF combined with posterior unilateral pedicle screw fixation
15987069|NCT02985138|Procedure|TLIF and bilateral pedicle screw fixation|TLIF combined with posterior bilateral pedicle screw fixation
15987070|NCT02985138|Device|Pedicle screw and cage|Pedicle screw and cage
15987071|NCT02985125|Drug|LEE011|Treatment cycles are 28 days long. It is taken orally. The dosage varies depending on the study arm.
15987072|NCT02985125|Drug|Everolimus|Treatment cycles are 28 days long. It is taken orally. On all arms, the dosage will be 2.5mg.
15987073|NCT02985112|Device|FFR and IVUS-NIRS|
15987074|NCT02985099|Drug|SRP plus Rosuvastatin gel|SRP followed by 1.2% Rosuvastatin placement into intrabony defect
15987075|NCT02985099|Drug|SRP plus placebo gel|SRP followed by placebo gel placement into intrabony defect
15987076|NCT02985086|Drug|Cefoxitin|
15987077|NCT02985086|Drug|oxytocin/misoprostol|
15987078|NCT02985073|Device|Veritas®|Biologic mesh
15987079|NCT02985073|Device|TIGR®|Non biologic mesh
15987080|NCT02985060|Device|Arctic Sun|"Induction phase: At a temperature of 4℃, a saline 500 mL or 1 L is intravenously administered.
~Arctic sun (surface freezing equipment) Target temperature: 35±0.5℃ Within 12 hours of the onset of symptoms, the therapeutic hypothermia is performed
~Maintenance phase:The use of bedside shivering assessment scale (BSAS) The use of Columbia anti-shivering protocol,Maintenance period: 48 hours
~Recovery phase:Rewarming velocity: 0.05~0.1℃ (within 30 hours)"
15987081|NCT02985060|Other|Standard treatment|"All the patients receive standard treatment modalities for stroke, which are applicable to the international treatment guidelines.
~In all the patients, neurological assessments and NIHSS scoring are performed on a daily basis for 4 days with the help of board-certified nurses or specialists in stroke.
~Blood pressure, respiratory rate and heart rate are measured at least once at a 4-hour interval for 4 days.
~Using an esophageal thermometer, the central temperature is measured at a 2-hour interval for 5 days."
15987082|NCT02985060|Drug|Saline|
15987083|NCT02985047|Other|Brief Admission|Participants randomised to Brief admission (BA) will participate in a negotiation together with their out-patient clinician and a representative from the ward. The aim of the negotiation is to form an individualised contract defining how BA will work for them. After signing the contract, will have the possibility to admit themselves to hospital according to the procedure stated in the contract.
15987084|NCT02985034|Procedure|RFA|Radiofrequency ablation (RFA) is performed according to routine practice, and then safety margin is assessed by a) visual side-by-side comparison between pre-RFA MRI and post-RFA CT, and b) registration software for two modalities.
15987085|NCT02985021|Drug|Carboplatin|Chemotherapy
15987086|NCT02985021|Drug|Docetaxel|Chemotherapy
15987087|NCT02984995|Drug|Quizartinib|Quizartinib was orally administered once daily every morning. Treatment with quizartinib was administered in 28-day cycles and continued until the discontinuation criteria for treatment were met.
15987088|NCT02984982|Drug|Alirocumab SAR236553|"Pharmaceutical form: Solution for injection
~Route of administration: Subcutaneous"
15987089|NCT02984982|Drug|Atorvastatin|"Pharmaceutical form: tablet
~Route of administration: oral"
15987090|NCT02984982|Drug|Rosuvastatin|"Pharmaceutical form: tablet
~Route of administration: oral"
15987091|NCT02984982|Drug|Fenofibrate|"Pharmaceutical form: tablet
~Route of administration: oral"
15987092|NCT02984982|Drug|Bezafibrate|"Pharmaceutical form: tablet
~Route of administration: oral"
15987093|NCT02984982|Drug|Ezetimibe|"Pharmaceutical form: tablet
~Route of administration: oral"
15987094|NCT02984982|Drug|Antiplatelets|"Pharmaceutical form: tablet or capsule
~Route of administration: oral"
15987095|NCT02984982|Drug|Anticoagulants|"Pharmaceutical form: tablet or capsule
~Route of administration: oral"
15987096|NCT02984956|Device|pleth variability index|
15987097|NCT02984943|Device|Hyperbaric Oxygen|30 treatments of Hyperbaric Oxygen.
15987098|NCT02984930|Drug|Administration of study drug (esomeprazole, mosapride)|Esomeprazole(Hanxium®) 40 mg once daily and mosapride (Gasmotin®) 5 mg t.i.d for 4 weeks.
15987099|NCT02984930|Drug|Administration of study drug (esomeprazole, placebo tablet)|Esomeprazole(Hanxium®) 40 mg once daily and placebo tablets that are identical to mosapride tablets t.i.d (3 times a day) for 4 weeks.
15987100|NCT02984930|Procedure|upper endoscopy, scintigraphy|After medication(4weeks), subjects will be undergo upper endoscopy and scintigraphy.
15987101|NCT02984917|Procedure|Anterior transversalis fascia approach|Patients will undergo inguinal hernia repair via the anterior transversalis fascia approach.
15987102|NCT02984917|Procedure|Preperitoneal space approach|Patients will undergo inguinal hernia repair via the preperitoneal space approach.
15987103|NCT02984904|Other|survey|survey
15987104|NCT02984891|Procedure|Optical Coherence Tomography (OCT)|Procedure will be performed using the OCT Dragonfly catheter is a hydrophilic-coated catheter that uses infrared light with a central wavelength between 1,250 and 1,350 nm. Axial resolution with OCT is 10-20 microns, and maximum tissue penetration with OCT is approximately 1.5 mm-3 mm.
15987105|NCT02984891|Procedure|Intravascular Ultrasound (IVUS)|Procedure will be performed using the IVUS Kodama catheter is a hydrophilic-coated catheter that used high-fidelity ultrasound transmission to capture high-definition images of coronary artery anatomy. It uses ultrasound waves with a frequency of 40 or 60 MHz, as opposed to 20 MHz in conventional IVUS, to improve resolution while optimizing tissue penetration. It provides axial resolution of < 40 microns and tissue penetration of 10 mm.
15987106|NCT02984878|Device|Revanesse Ultra|Nasolabial Fold correction
15987107|NCT02984865|Drug|Sulfentanyl|
15987108|NCT02984865|Drug|Nalbuphine|
15987109|NCT02984865|Drug|flubiprofen axetil|
15987110|NCT02984865|Procedure|rectus sheath block|Transversus abdominis plane (TAP) block combined with rectus sheath (RS) block will be applied in Group ESRD
15987111|NCT02984852|Drug|Darunavir (DRV)|Darunavir 800 milligram (mg) will be taken orally in FDC together with COBI(150mg)/FTC(200mg)/TAF(10mg).
15987112|NCT02984852|Drug|Cobicistat (COBI)|Cobicistat 150 milligram (mg) will be taken orally in FDC together with DRV(800mg)/FTC(200mg)/TAF(10mg).
15987113|NCT02984852|Drug|Emtricitabine (FTC)|Emtricitabine 200 milligram (mg) will be taken orally in FDC together with COBI(150mg)/DRV(800mg)/TAF(10mg).
15987114|NCT02984852|Drug|Tenofovir Alafenamide (TAF)|Tenofovir Alafenamide 10 milligram (mg) will be taken orally in FDC together with COBI(150mg)/FTC(200mg)/DRV(800mg).
15987115|NCT02984839|Device|Stimpod NMS450® Nerve Stimulator, by Xavant™ Technology|Quantitative train-of-four (TOF) ratio will be recorded in the post anesthesia care unit (PACU) via Stimpod NMS450
15987116|NCT02984826|Other|Strength training|The specific ST group trained and fulfilled a 10 week training diary. The ST consisted of 4 shoulder exercises. During the training the relative loading was progressively increased from 12 repetitions maximum (RM) (70% of maximal intensity) at the beginning to 8 RM (80 % of the maximal intensity). ST was performed with slow concentric and eccentric muscle contractions with resistance from the elastic bands.
15987117|NCT02984826|Other|Ergonomic and posture|The control group was instructed in ergonomics and posture correction (EP). They were instructed to pay attention to their sitting posture, and how they used a computer or other working tools. Further they were asked to do a posture correction exercise 3 times a day with 10 repetitions. The EP were seen twice during the 10 week period, and had a phone call every 2 weeks. After 10 weeks they were instructed that they should stop the exercise but continue to be conscious of their ergonomics and sitting position.
15987118|NCT02984813|Drug|GlaucoHealth|Containing alpha lipoic acid, citicoline, Co-enzyme Q10, Ginkgo biloba extract, grape seed extract, N-acetyl-cysteine, curcumin, and green tea extract
15987119|NCT02984813|Drug|GlaucoSelect|Containing curcumin, bilberry extract, and grape seed extract
15987120|NCT02984813|Drug|Placebo|No active ingredients
15987121|NCT02984800|Other|Anesthesia induction|All patients will have inhaled induction of anesthesia by facemask using oxygen and 8% sevoflurane for 2 to 4 minutes followed by placement of an IV cannula. After performing PVB injections, the sevoflurane concentration will be decreased to 0.4% to 0.8% and maintained until completion of surgery.
15987122|NCT02984800|Other|PVB injection at L1-L2|Patients will receive a single PVB injection at L1-L2 and placebo PVB injections at T12-L1 and L2-L3.
15987123|NCT02984800|Other|PVB injections at T12-L1, L1-L2 and L2-L3.|Patients will have PVB injections at T12-L1, L1-L2 and L2-L3.
15987124|NCT02984787|Procedure|3D Laparoscopic total gastrectomy|When participants with advanced proximal gastric cancer are randomized in the 3D laparoscopic-assisted totalgastrectomy (3D-LTG) group, they will received 3D-LTG with spleen-preserving splenic hilum lymph nodes dissection
15987125|NCT02984787|Procedure|2D Laparoscopic total gastrectomy|When participants with advanced proximal gastric cancer are randomized in the 2D laparoscopic-assisted totalgastrectomy (2D-LTG) group, they will received 2D-LTG with spleen-preserving splenic hilum lymph nodes dissection
15987126|NCT02984774|Procedure|Cystectomy|Segment of cystic wall from the patients for planned cystectomy was taken after operation and was preserved at -80º Celsius for further analysis
15987127|NCT02984774|Procedure|Endometrial sampling|Endometrial sampling was performed at the same operation with the planned operation for the main indication and was preserved at -80º Celsius for further analysis
15987128|NCT02984774|Procedure|Peripheric blood sampling|4 cc peripheric venous blood was sampled into the EDTA(Ethylenediaminetetraacetic acid)-containing tubes during catheterization for anesthesia was preserved at 4º Celsius for further analysis
15987129|NCT02984774|Procedure|Ovarian tissue sampling|2cm linear tissue sample from ovarian cortex was performed at the same operation with the planned operation for the main indication and was preserved at -80º Celsius for further analysis
15987130|NCT02984761|Radiation|Stereotactic Radiotherapy|Stereotactic radiotherapy uses high doses of ionizing energy to treat cancer cells with image guidance. The treatment is delivered in an outpatient setting, and for purposes of this trial is delivered in 3-5 fractions.
15987131|NCT02984761|Procedure|Anatomic Pulmonary Resection|An anatomic pulmonary resection is an oncologic procedure that dissects out an anatomically defined segment of the lung to remove all of the lung tissue around a lung tumor. It requires an operation with general anesthesia, with a short hospital stay. The procedure entails removal of lymph nodes inside the chest that might not be easily accessible without an operation.
15987132|NCT02984748|Device|Cochlear implant|
15987133|NCT02984735|Other|Evaluation|Descriptive characteristics including age, height and weight were recorded. Chewing performance level was determined with the Karaduman Chewing Performance Scale (KCPS). Each child was placed in a sitting position (either on a chair or on his/her mother's arm) with the head upright and with the midline position and arms and legs supported, and required to bite and chew a standardized biscuit, and no clue was given on how to chew. The physical therapist rated the chewing performance according to the KCPS. All children underwent a physical examination by a physical therapist to determine gross motor function by applying the Gross Motor Function Classification System (GMFCS). In addition to GMFCS, number of affected limbs of the children was also noted.
15987134|NCT02984722|Drug|Metformin|
15987251|NCT02983825|Device|Continuous positive airway pressure (CPAP); level changes|as per arm description
15987135|NCT02984709|Behavioral|Positive Psychology Intervention|Health Behavior Contract - Baseline visit Education Packet - Baseline visit Positive psychology training for teen and parents - baseline visit Parent praise reminder (text message) - one time per week (over 8 week intervention period) Teen gratitude message (text message) - every Monday (over 8 week intervention period) Teen positive value message (text message) - every Wednesday (over 8 week intervention period) Teen mood booster (text message) - every Thursday and Saturday and alternative Sundays (over 8 week intervention period) Small gift ($5 gift card code sent every 2 weeks for 8 weeks)
15987136|NCT02984709|Behavioral|Education|Health Behavior Contract - Baseline visit Education Packet - Baseline visit
15987137|NCT02984696|Drug|1 mg of transdermal estradiol daily and 10mg of oral MPA|
15987138|NCT02984683|Drug|SAR566658 (ACT14884)|Pharmaceutical form:Solution Route of administration: Intravenous
15987139|NCT02984670|Behavioral|Cognitive Therapy|Cognitive Therapy involves challenging negative automatic thoughts about sleep and the use of behavioral experiments to challenge and test five cognitive processes (i.e., worry, dysfunctional thoughts, monitoring, safety behaviours, misperception) proposed to perpetuate insomnia.
15987140|NCT02984670|Behavioral|Behavior Therapy|Behavior Therapy involves the use of stimulus control and sleep restriction in order to reverse maladaptive sleep habits (time in bed, napping, bedtime variability, rise time variability) proposed to maintain insomnia. It also involves the practice of sleep hygiene principles.
15987141|NCT02984670|Behavioral|Waitlist.|The waitlist serves as a passive control which will receive the same measures administered to the cognitive and behaviour therapy groups.
15987142|NCT02984657|Procedure|Surgical patients in 2012 with anesthesia and nursing staff less attuned to intraoperative RTP.|RTP, reverse Trendelenburg positioning
15987143|NCT02984657|Procedure|Surgical patients in 2015 with enhanced anesthesia and nursing staff awareness and use of intraoperative RTP.|RTP, reverse Trendelenburg positioning
15987144|NCT02984644|Drug|Dapagliflozin|Three 5-hour measurements (after dapagliflozin 10mg administration) of endogenous glucose production (EGP) will be performed on separate days.
15987145|NCT02984644|Drug|Placebo|Three 5-hour measurements (after placebo administration) of endogenous glucose production (EGP) will be performed on separate days.
15987146|NCT02984631|Procedure|Preventing pulm HTN during exercise|Balloon catheter is inflated within the IVC to maintain pulmonary pressures during exercise.
15987147|NCT02984618|Procedure|Sphenopalatine ganglion block|Cotton- tipped applicators inserted up through the nose followed by infusion of ligdocaine through the applicators.
15987148|NCT02984618|Procedure|Epidural blood patch|Autologous sterile blood (20ml) will be infused in the lombar epidural space.
15987149|NCT02984605|Dietary Supplement|nutritional meal replacement|1 times a day with bags of nutritional meal replacement + individualized exercise prescription
15987150|NCT02984592|Behavioral|physical exercise|regular exercise programs in the previous 6 months.
15987151|NCT02984579|Device|YD REBA MTB-MDR|Conducted on stored, de-identified leftover samples. A line probe assay designed for detection of Multidrug-resistant tuberculosis (MDR-TB). The REBA MTB-MDR® assay is a qualitative in vitro test for the identification of Mycobacterium tuberculosis (MTB) complex and its susceptibility to rifampin and isoniazid from cultured samples and smear positive specimens.
15987152|NCT02984579|Device|Hain Genotype MTBDRplus V1|Conducted on stored, de-identified leftover samples. There is only one Line Probe Assay for molecular MTB drug resistance globally available, the GenoType® MTBDRplus V.1 from Hain Lifescience. This assay includes rpoB gene probes for Rifampin (RIF) resistance, katG gene probes for high level Isoniazid (INH) resistance, and inhA gene probes for determination of low level INH resistance
15987153|NCT02984579|Device|Hain Genotype MTBDRplus V2|Conducted on stored, de-identified leftover samples. An updated version of the Hain Genotype MTBDRplus V1 assay, the Genotype MTBDRplus V.2 line probe assay, showed increased sensitivity for MTB detection in the 2 studies published so far
15987154|NCT02984566|Device|Kilovoltage Intrafraction Monitoring|KIM is a novel intrafraction real-time tumour localization method. It involves a single gantry-mounted kV x-ray imager acquiring 2D projections of implanted fiducial markers. 3D positions are then reconstructed by maximum likelihood estimation of a 3D probability density function.
15987155|NCT02984540|Other|Low-Carbohydrate Diet|Participants assigned to the Modified Ketogenic-Mediterranean Diet will keep their carbohydrate consumption below 20 grams per day throughout the 6-week intervention.
15987156|NCT02984540|Other|Low-Fat Diet|Participants assigned to the Low-Fat Diet will be encouraged to limit their amount of fat intake to <40 grams/day, while eating plentiful fruits, vegetables, and carbohydrates containing adequate fiber.
15987157|NCT02984527|Device|wet wipes|intimate hygiene with disposable wet wipes
15987158|NCT02984527|Device|water and soap|Intimate hygiene with water and soap
15987159|NCT02984514|Radiation|Positron emission tomography with tracer 18F-deoxy glucose|Assessment of activity of brown adipose tissue with positron emission tomography using the tracer 18F-deoxy glucose
15987160|NCT02984501|Radiation|Radiation|Radiotherapy target volumes are established by CT scan and PET-CT scan. Radiotherapy is delivered with a total dose of 54-59 Gy with fractionation of 1.8 Gy daily for 5 days a week. The Planning Target Volume (PTV) is defined by CTV with a safety margin of 1cm in all directions to include organ motion and set-up errors. Organs at risk for radiation-induced side effects are contoured on the dose planning CT and dose volume histograms (DVH) are calculated. All treatments are delivered with a 15-MV linear accelerator (Varian Medical System) with a multifield isocentric technique using a multileaf collimator. A quality-control protocol are applied for all patients with periodical digital portal images to evaluate the precision of the set-up.
15987161|NCT02984501|Drug|Chemotherapy|The induction phase of the treatment plan is designed to administer gemcitabine 1000 mg/mq and oxaliplatin 100 mg/mq every 14 days for four doses. Chemotherapy concurrent to conformal radiation therapy is gemcitabine at the dose of 600 mg/mq weekly.
15987162|NCT02984488|Procedure|single visits|Endodontic treatment is done and completed in a single visit using protaper next rotary system.
15987163|NCT02984488|Procedure|two visits|Endodontic treatment is done and completed in two visits using protaper next rotary system.
15987164|NCT02984475|Drug|Metformin|
15987213|NCT02984137|Other|testing, evaluation, sampling|neuroimaging biomarkers using positron emission tomography and magnetic resonance imaging, and evaluation of neurological & neurocognitive status by using a predefined neuropsychological assessment battery.
15987165|NCT02984462|Procedure|percutaneous Akin osteotomy|The act to AKIN is osteotomy in percutaneous; This technique can be performed with or without fixation, and both methods make reference in the literature. With fixation method to get rid of the risk of loss of the surgical reduction of the misalignment, but requires an additional surgical procedure marked by the implementation of a percutaneous cannulated screw on part of the osteotomy. Without fixing method allows to get rid of this gesture, and risk a possible annoys by osteo-synthesis material. Surgical dressings of surgery of hallux valgus allow to keep the reduction for 15 days. Both techniques give excellent results and are performed in our service of routinely.
15987166|NCT02984449|Behavioral|Pre+post-operative Cardiac rehabilitation|CR has the aim to influence favorably the underlying cause of cardiovascular disease, as well as to provide the best possible physical, mental and social conditions (BACPR, 2012).
15987167|NCT02984449|Behavioral|Postoperative Cardiac rehabilitation|CR has the aim to influence favorably the underlying cause of cardiovascular disease, as well as to provide the best possible physical, mental and social conditions (BACPR, 2012).
15987168|NCT02984436|Procedure|Blood Sample|Blood samples will be collected from study participants for hs-cTnT analysis. Results of hs-cTnT will be used for research purposes only. Providers and participants will be blinded to results and participants will be treated by their healthcare providers per the standard of care.
15987169|NCT02984436|Behavioral|HEART Score|The HEART Score is a prospectively studied scoring system to help emergency departments risk-stratify chest pain patients. Patients score on a scale of 0-10.
15987170|NCT02984410|Radiation|Intensity-Modulated Radiation Therapy (IMRT)|IMRT (Simultaneous Integrated Boost (SIB) and accelerated regimen) with selective neck node dissection
15987171|NCT02984410|Procedure|Trans Oral Surgery (TOS)|TOS (Trans Oral Laser Microsurgery (TLM), Trans Oral Robotic Surgery (TORS), conventional) with selective neck node dissection
15987172|NCT02984397|Drug|Ketotifen Fumarate|Ketotifen is a second-generation noncompetitive H1-antihistamine and mast cell stabilizer. It is most commonly sold as a salt with fumaric acid, ketotifen fumarate, and is available in two forms. In its ophthalmic form, it is used to treat allergic conjunctivitis, or the itchy red eyes caused by allergies. In its oral form, it is used to prevent asthma attacks.
15987173|NCT02984397|Drug|Placebo|
15987174|NCT02984397|Other|Standard of Care|
15987175|NCT02984384|Drug|Acetylsalicylic acid|The Aspirin intervention will be 81 mg enteral (by mouth, feeding tube or rectal) twice a day with no variation in dosing allowed.
15987176|NCT02984384|Drug|Low Molecular Weight Heparin (LMWH)|The LMWH intervention will be 30 mg enoxaparin subcutaneous (under the skin) twice a day with variations in dosing allowed, per the standard of care at sites, as needed for patients who are very obese or exhibit renal dysfunction.
15987177|NCT02984371|Procedure|Coronary artery bypass grafting|
15987178|NCT02984371|Procedure|Epicardial ganglionated plexi ablation|
15987179|NCT02984371|Procedure|implantable loop recorder|
15987180|NCT02984358|Other|Animal protein based diet|
15987181|NCT02984358|Other|Low-nucleotide mycoprotein based diet|
15987182|NCT02984358|Other|High-nucleotide mycoprotein based diet|
15987183|NCT02984345|Other|Mycoprotein beverage|Mycoprotein protein beverage
15987184|NCT02984345|Other|Milk protein beverage|Milk protein beverage
15987185|NCT02984332|Other|Lower limb immobilisation (leg brace)|
15987186|NCT02984319|Dietary Supplement|Cherry versus placebo concentrate|Acute cherry concentrate
15987187|NCT02984306|Dietary Supplement|Cherry powder|
15987188|NCT02984306|Dietary Supplement|Placebo|
15987189|NCT02984293|Drug|Atorvastatin|Atorvastatin 80 mg once daily for 28 days.
15987190|NCT02984293|Drug|Placebo|Placebo once daily for 28 days.
15987191|NCT02984267|Device|Ultrasound|Using ultrasound guidance to evaluate the spine prior to epidural placement
15987192|NCT02984267|Other|Palpation|Using palpation only to evaluate the spine prior to epidural placement
15987193|NCT02984254|Device|Womac|Answer Womac questionnaires at baseline, 1 month, 3 months and 1 year
15987194|NCT02984254|Device|Lequesne|Answer Lequesne questionnaires at baseline, 1 month, 3 months and 1 year
15987195|NCT02984254|Device|Timed-up-and-go (TUG)|Perform Timed-up-and-go (TUG) at baseline, 1 month, 3 months and 1 year
15987196|NCT02984254|Device|five-times-sit-to-stand-test (FTSST)|Perform the five-times-sit-to-stand-test (FTSST) at baseline, 1 month, 3 months and 1 year
15987197|NCT02984254|Device|Six-minute walk test.|Perform six-minute walk test at baseline, 3 months and 1 year
15987198|NCT02984254|Device|functional patellofemoral neoprene brace|Use the functional patellofemoral neoprene brace for 2 hours/day minimum - 12 hours/day maximum
15987199|NCT02984254|Device|neoprene sleeve brace.|Use the neoprene sleeve brace for 2 hours/day minimum - 12 hours/day maximum
15987200|NCT02984241|Behavioral|eHealth Coping Skills Training|Access to a specialized coping skills training website
15987201|NCT02984241|Behavioral|eHealth Usual Web Care|Access to a website in which helpful information on coping that is available on the internet has been systematically collected and organized in one place for easy retrieval
15987202|NCT02984241|Behavioral|Coach Support|Access to a professional coach by phone
15987203|NCT02984228|Biological|PRP|
15987204|NCT02984228|Drug|Hyaluronic Acid|
15987205|NCT02984228|Device|Ultrasound|
15987206|NCT02984202|Device|auditory midbrain implant (AMI)|
15987207|NCT02984189|Other|Inspiratory muscle training|The inspiratory muscle training (IMT) will be realized, to compare three intensities differents the training (Inspiratory critical pressure, 60% maximal inspiratory pressure and sham). The IMT will be performed for 11 weeks (33 sessions, 3 times/week, 1-hour duration). The session will consist of 5-min warm-up (50% of the training load) and 3 sets of 15 minutes (breathing against 100% of the training load) with 1-min interval between them, using a linear inspiratory load resistor (Device: PowerBreathe K5).
15987208|NCT02984176|Drug|Simethicone Tab 40 mg|3 tablets of Simethicone Tab 40 mg (one tablet after each meal) and to fast overnight the day before the operation.
15987209|NCT02984176|Drug|Placebo Tablets|3 tablets of Placebo Tablets (one tablet after each meal) and to fast overnight the day before the operation.
15987210|NCT02984163|Behavioral|Exercise|Exercise sessions will include a combination of aerobic, resistance, balance, and flexibility exercises delivered in a circuit-type class setting or group personal training format.
15987214|NCT02984124|Behavioral|Informed Assent Discussion|"Participants randomized to the intervention arm will participate in a discussion about CPR with a study doctor that follows these steps:
~Patient's values and preferences for therapies and outcomes elicited from patient and family; overall therapeutic goals formulated
~Description of CPR and dying process provided
~Personalized explanation provided about probable lack of achieving any reasonable therapeutic goal with CPR (i.e. why s/he is a poor candidate for CPR due to underlying illness)
~Patient and family informed that due to severe underlying illness and high likelihood that CPR will be burdensome/harmful and will not provide benefit, CPR will not be offered unless they disagree (except in rare circumstance where overall therapeutic goals from step 1 are to preserve life regardless of quality of that life) Assessment of patient's and family's understanding of issues discussed; patients may actively disagree and request CPR be performed, but CPR not explicitly offered"
15987215|NCT02984124|Behavioral|Usual Care with Attention Control|Participants who are randomized to the usual care arm will receive a friendly visit in the hospital from research personnel to ask if they have any questions or concerns. Follow up assessments and time windows will be explained. Importance of their participation in the study will be emphasized.
15987216|NCT02984111|Drug|normal saline|
15987217|NCT02984111|Drug|erythropoietin|
15987218|NCT02984098|Drug|Dextrose|before heel lance, 2ml oral dextrose gel 25%or 40% was administered, and pain related intensity was evaluated with premature infant pain profile scale
15987219|NCT02984085|Drug|Genetically corrected cultured epidermal autograft (ATMP)|"Genetically corrected cultured epidermal autograft (Hologene 7) is intended for transplantation onto surgically prepared blistering skin areas of RDEB patients and permanent regeneration of a healthy, functional and renewing epidermis sustained by the engraftment of transduced epidermal stem cells.
~By taking some autologous epidermal cells, a new layer of transgenic tissue is grown in the laboratory. This layer of tissue is then implanted by a surgeon into the damaged area. The implantation can be done in one or more areas and repeated in case of failure of the first surgery."
15987220|NCT02984072|Drug|Menthol|Topical menthol in aqueous cream
15987221|NCT02984072|Drug|Aqueous Cream|placebo
15987222|NCT02984059|Genetic|Genomic DNA|blood draw
15987223|NCT02984059|Genetic|RNA analysis|Mucosal Biopsy via colonoscopy
15987224|NCT02984059|Genetic|Microbiome|Stool microbiome
15987225|NCT02984059|Other|Calprotectin|stool or blood analysis for calprotectin
15987226|NCT02984059|Other|Pain questionnaires|PSDS PCS-C/P PBI APPT
15987227|NCT02984059|Other|Anxiety/Depression Questionnaires|RCADS-25 CSI-24 ARCS
15987228|NCT02984046|Drug|Protein CC16|
15987229|NCT02984033|Radiation|Head and Neck patients|Treatment consists of Intensity Modulated Radiation Therapy (until 2.2 Gy) with a total dose of 50-66 Gy in post-operative setting and 66-72 Gy in radical setting.
15987230|NCT02984007|Behavioral|Motivational Interviewing|"Mothers randomized in the intervention group will receive an educational session based on the motivational interviewing (MI) approach with a research assistant (RA). The RA will have first received a standardized training session on the content and techniques of MI.
~The MI intervention will be carried out in simple and understandable language in order to allow discussion and questions from parents rather than provide prescriptive and direct information. The intervention will last approximatively 15 to 20 minutes."
15987231|NCT02984007|Other|Information flyer|Mothers randomized in the control group will receive a locally information flyer on childhood vaccines without any oral explanation by the research assistant.
15987232|NCT02983994|Device|TURBUHALER®|
15987233|NCT02983994|Device|SPIROMAX®|
15987234|NCT02983981|Drug|Topicort Topical Spray|open label Topicort spray
15987235|NCT02983968|Other|Description of the cirrhosis management|
15987236|NCT02983955|Device|UPnRIDE Powered Wheelchair|The UPnRIDE Powered Wheelchair device is a product which changes people position from sitting to standing and standing to sitting. The product provides indoor and outdoor mobility.
15987237|NCT02983942|Dietary Supplement|ketogenic diet|Ketogenic diet is given to maintain blood ketone level above 2 mmol/L.
15987238|NCT02983942|Dietary Supplement|Routine diet|Routine diet is given without blood ketone requirement
15987239|NCT02983929|Procedure|Rehabilitation after total knee arthroplasty|All the included patients followed a rehabilitation program in the Polyvalent Geriatric Rehabilitation Clinic after total knee arthroplasty.
15987240|NCT02983916|Procedure|Adhesiolysis|Diagnostic laparoscopy or laparotomy with lysis of adhesions.
15987241|NCT02983903|Procedure|transbronchial biopsy|
15987242|NCT02983890|Drug|Dicloxacillin|"Tablets containing dicloxacillin are taken 500mg 2x 3 times per day, for 10 days. Followed by test-day nr 1 at day 11.
~Both arms receives both treatments, randomly assigned"
15987243|NCT02983890|Drug|Placebos|"No drug are taken for 10 days. Non-blinded. Followed by test-day nr 1 at day 11.
~Both arms receives both treatments, randomly assigned"
15987244|NCT02983877|Behavioral|iTAB-CV|"Stage 1 of the intervention will be introduced. Researchers will conduct an interview in order to customize iTAB-CV for each participant at the baseline session. In the first month, participants will receive alternating daily texts with educational and motivational content and a daily mood rating request to both monitor their mood and to determine adherence to the intervention.
~In the second stage for the following month, participants will receive daily texts which will include medication reminders, contextual cues, and immediate reinforcement for medication taking behavior in addition to the content from stage 1."
15987245|NCT02983864|Behavioral|BASICS|A one session intervention focused on reducing drinking with motivational interviewing
15987246|NCT02983864|Behavioral|Integrated BASICS|A one session intervention focused on reducing drinking and sexual behavior while drinking
15987247|NCT02983864|Behavioral|Relaxation|A one session intervention focused on increasing relaxation skills
15987248|NCT02983864|Behavioral|Integrated Bystander|A one session intervention focused on reducing sexual assault with a focus on the role of alcohol
15987249|NCT02983851|Procedure|Noninvasive mechanical ventilation|Noninvasive mechanical ventilation will be delivered to the patient through a mask. The mask will be adjusted and connected to a ventilation system.
15987250|NCT02983851|Procedure|Invasive mechanical ventilation|Invasive mechanical ventilation will be initially performed by using the volume controlled mode, and could be adjusted to pressure controlled mode or other modes based on clinical situation.
15987252|NCT02983799|Drug|OLAPARIB|300 mg olaparib tablets taken orally twice daily
15987253|NCT02983786|Drug|Indocyanine Green|ICG will be injected to derive absolute CBF and calibrate the DCS monitor to yield continuous absolute CBF. During each 12-hour monitoring session, for up to 14 days, the ICG will be injected at baseline(0.2 mg/kg,(4), every four hours (or less if signal is stable).
15987254|NCT02983773|Drug|THC 7.2%|1 smoked marijuana cigarette with 7.2% THC
15987255|NCT02983773|Drug|THC 3.0%|1 smoked marijuana cigarette with 3.0% THC
15987256|NCT02983773|Drug|Placebo|1 smoked placebo marijuana cigarette
15987257|NCT02983760|Device|Planar V/Q-based strategy|Strategy based on planar pulmonary scintigraphy
15987258|NCT02983760|Device|CTPA-based strategy|Strategy based on pulmonary angiography
15987259|NCT02983760|Device|V/Q SPECT-based strategy|Strategy based on pulmonary tomoscintigraphy
15987260|NCT02983747|Other|PRP Treatment(P)|Ultrasound(Philips® iU22 ultrasound system) guided intra-disk injection using 2 ml of platelet rich plasma, containing 0.2 ml of calcium chloride(SINE®, SHANGHAI XINYI PHARMACEUTIAL Co . Ltd .) per treatment
15987261|NCT02983747|Drug|Medication Treatment(Loxoprofen Sodium tablets,M)|Loxoprofen Sodium tablets(LOXONNIN®, DAICHI SANKYO PHARMACEUTIAL (SHANGHAI) Co . Ltd .)，P.O., 60mg, three times a day
15987262|NCT02983734|Drug|D-cycloserine|Partial agonist of N-methyl-D-aspartate (NMDA) receptor
15987263|NCT02983734|Drug|Placebos|Sugar pill
15987264|NCT02983721|Procedure|transradial|transradial route for coronary angiography and PCI
15987265|NCT02983721|Procedure|Transfemoral|transfemoral route for coronary angiography and PCI
15987266|NCT02983708|Biological|Peripheral blood mononuclear cells (mPBMC)|
15987267|NCT02983708|Drug|G-CSF|
15987268|NCT02983708|Drug|Placebo|
15987269|NCT02983695|Drug|TIL-TC150|The active ingredients in TIL-TC150 are tetrahydrocannabinol (THC) and Cannabidiol (CBD), isolated from the Cannabis sativa L. strains produced by Tilray, and formulated into an oral liquid drug product.
15987270|NCT02983682|Drug|Lidocaine Infusion|Patients will receive lidocaine infusion of 42 micrograms/kg/minute over tow hours for a total of 5 mg/kg.
15987271|NCT02983669|Dietary Supplement|Thyme|Thyme capsule 350 mg twice daily
15987272|NCT02983669|Other|Placebo|Placebo capsule 350 mg twice daily
15987273|NCT02983656|Biological|live attenuated varicella vaccine|
15987274|NCT02983630|Other|Penicillin allergy testing|The standard protocol for testing for penicillin hypersensitivity, including initial skin testing with prick and intradermal evaluation followed by oral challenge if skin testing is negative.
15987275|NCT02983617|Drug|Tirabrutinib|80 mg (1 x 80 mg or 4 x 20 mg or 2 x 40 mg) tablets administered orally once daily
15987276|NCT02983617|Drug|Entospletinib|400 mg (2 x 200 mg) tablets administered orally once daily
15987277|NCT02983617|Drug|Obinutuzumab|Obinutuzumab 100 mg on Day 1, 900 mg on Day 1 or 2, and 1000 mg subsequently for up to 8 doses administered intravenously over 21 weeks
15987278|NCT02983604|Drug|GS-5829|Tablet(s) administered orally once daily
15987279|NCT02983604|Drug|Exemestane|25 mg tablet administered orally once daily (or in accordance with locally approved labeling)
15987280|NCT02983604|Drug|Fulvestrant|"Administered every 28 days (± 3 days) intramuscularly in accordance with locally approved labeling
~Participants initiating fulvestrant on Cycle 1 Day 1 and have not received any prior dose of fulvestrant will receive a single additional dose of fulvestrant on Cycle 1 Day 15."
15987281|NCT02983591|Drug|Misoprostol after delivery|Patients will receive 1000 mcg Misoprostol per rectum
15987282|NCT02983591|Drug|Oxytocin after delivery|Patients will receive 20 units oxytocin intravenously in one liter of Lactated Ringer solution at a rate of 150ml/h
15987283|NCT02983591|Drug|Oxytocin before delivery|All patients will receive oxytocin 0.5-1 milliUnit/min IV, titrated to 1-2 milliUnit/min every 15-60 min before delivery to induce labor
15987284|NCT02983578|Drug|Danvatirsen|Given IV
15987285|NCT02983578|Biological|Durvalumab|Given IV
15987286|NCT02983565|Device|Intelligent oxygen therapy system (iO2Ts)|
15987287|NCT02983552|Other|iPad®|Binocular therapy using a Dig Rush application on an iPad®
15987288|NCT02983552|Other|Spectacle correction|Spectacle correction for all waking hours, 7 days per week
15987289|NCT02983526|Device|Total hip replacement (2 different designs)|Patients will randomly receive either CFP or Corail stem
15987290|NCT02983513|Behavioral|Early Intervention|
15987291|NCT02983487|Procedure|Nasopharyngeal sampling|Nasopharyngeal sample by aspiration or swabbing
15987292|NCT02983487|Procedure|Blood Sampling|Blood sample by the tip of a finger (fingerprick)
15987293|NCT02983474|Procedure|cholecystectomy|"Laparoscopic surgery
~Reverse Trendelenburg position
~Skin incision and trocar insertion
~CO2 gas insufflation
~Intra-abdominal inspection and gallbladder exposure
~Gallbladder traction
~Calot triangle exposure
~Cystic artery and cystic duct isolation
~Gallbladder bed dissection
~Bleeding control
~Gallbladder extraction
~Trocar removal and wound closure
~Open surgery
~Supine position
~Skin incision
~Intra-abdominal inspection and gallbladder exposure
~5. Gallbladder traction 6. Calot triangle exposure 7. Cystic artery and cystic duct isolation 8. Gallbladder bed dissection 9. Gallbladder extraction 10. Bleeding control 11. Wound closure"
15987294|NCT02983461|Drug|Sildenafil|Sildenafil, 20mg x 3 times a day for 10 weeks
15987295|NCT02983461|Drug|Placebo|Placebo oral tablet, 3 times a day for 10 weeks
15987296|NCT02983448|Device|transcutaneous vagus nerve stimulation|All patients will receive both active and sham transcutaneous vagus nerve stimulation, with the order being randomized
15987297|NCT02983435|Other|G1 - Thrust manipulation|Osteopathic manipulation with Thrust technique. The Group 1 (G1) will receive the Thrust technique applied at the level of dysfunction. Subject in lateral decubitus, with one lower limb extended and the other in flexion, to the level of the targeted vertebra; upper trunk rotated back until the same vertebra; at the end of the range of movement will be applied the high speed and low amplitude impulse (Thrust).
15987370|NCT02982889|Drug|LIQ865B bupivacaine formulation|single subcutaneous injection in medial calf
15987371|NCT02982889|Drug|Diluent for LIQ865|Sterile diluent composed of 12.5mg/g sodium hyaluronate, 5.8mg/g sodium chloride, 1mg/g polysorbate 80, 6.1mg/g Tris base, in sterile water for injection - single subcutaneous injection
15987372|NCT02982889|Drug|0.5% bupivacaine hydrochoride|single subcutaneous injection
15987298|NCT02983435|Other|G2 - Muscle Energy|Osteopathic manipulation with Muscle Energy technique. The Group 2 (G2) will receive the Muscle Energy technique applied at the level of dysfunction. Subject in lateral decubitus, with the upper and lower trunk flexed until the target vertebra, and upper trunk rotated back to the level of the same vertebra; lumbar in lateral flexion (using the subject's feet) until the target vertebra. Following the command the subject will perform an isometric contraction of 3-5 seconds against the therapist's hand (pushing the hand towards the floor), repeated 3 times.
15987299|NCT02983422|Drug|aminophylline|To increase the dose of frusemide until 15mg/h with Syringe pumps. If the urine doesn't reach 1ml/kg/h,then combined with Aminophylline(loading dose of 5mg/kg，and maintenance dose of 0.5mg/kg)
15987300|NCT02983422|Drug|frusemide|Use frusemide with Syringe pumps,maximum dose to 15mg/h
15987301|NCT02983422|Drug|normal saline|Placebo bolus followed by IV infusions of normal saline (0.9%) every hour (matched by volume and appearance to the treatment group)
15987302|NCT02983409|Radiation|Pstone|A adult patients who were diagnosed as urinary stone by the urinary CT
15987303|NCT02983396|Device|Diagnostic accuracy of Mini Relf Device|Evaluation of the Mini Relf Device when it is applied on daily basis at home and during coronary angioplasty at 60 second acute coronary occlusion angioplasty
15987304|NCT02983383|Procedure|TAP block group (Group T)|At the end of the operation, patients in Group T in the supine position will have a USI probe placed at the middle point between the costal edge and iliac crest (within the Petit triangle) after necessary antiseptic conditions are ensured. Then after the abdominal muscle layers are observed, the needle (Stimuplex Ultra 22G, 100mm, B.Braun, Germany) tip will be advanced through the muscle layers and pass the fascia, feeling the fascial click, monitored by USI in controlled fashion. After feeling the second click (passing the internal oblique muscle fascia), a test dose of 0.5-1 ml saline will be administered to determine the localization of the needle tip. Then noting the location, with frequent aspiration local anesthetic agent will be administered to the neurofascial plane for TAP block.
15987305|NCT02983383|Procedure|spinal anesthesia|Patients in Group P will have adjuvant added to spinal anesthesia (25 G, Quincke spinal anesthesia needle, Egemen,Turkey).
15987306|NCT02983370|Procedure|Minicraniotomy|The surgical method for the implantation of the intracortical microelectrodes is straightforward and follows the standard neurosurgical procedures. Briefly, after the scalp is prepped with an antiseptic, a small skin incision is made. Then the skin and muscles are lifted off from the bone and folded back. Next, one small burr hole or a minicraniotomy of approximately 1.5 cm is made in the skull. This is a minimally invasive procedure that allows an easy access to the brain and is a standard procedure widely used in neurosurgery.
15987307|NCT02983357|Radiation|CT, X-Ray|2 anterior-posterior (AP) radiographs of the glenohumeral joint, one in internal rotation and the other in external rotation, along with axillary lateral films, will be completed of the affected operated shoulder. Also, a computed tomographic scan without contrast performed of same shoulder.
15987308|NCT02983357|Other|Physical assessment|Physically evaluate for shoulder function and pain using American Shoulder Elbow Score (ASES) Constant score and the Simple Shoulder Test to obtain specific shoulder functional, motion,and strength outcomes.
15987309|NCT02983357|Other|Questionnaire|Rand Short Form Health Survey (Rand SF-36) which is a patient completed quality of life measurement
15987310|NCT02983344|Drug|Ropivacaine|Fascia iliaca compartment block using ropivacaine
15987311|NCT02983344|Drug|Fentanyl|Intravenous fentanyl
15987312|NCT02983344|Device|Ultrasound|Ultrasound-guided fascia iliaca compartment block
15987313|NCT02983331|Procedure|complications during procedure|patients may have anesthesia related complications during procedure
15987314|NCT02983305|Device|Head-Mounted Display|Head-mounted displays (HMD) are a class of technology that are worn on the user's head and project an image either in front of or into the eye.
15987315|NCT02983292|Device|PyroTITAN™ HRA|Humeral Resurfacing
15987316|NCT02983279|Dietary Supplement|Dietary Intervention|Undergo caloric restriction diet
15987317|NCT02983279|Other|Counseling|Undergo counselor-led dietary counseling
15987318|NCT02983279|Procedure|Therapeutic|Undergo standard of care surgery
15987319|NCT02983266|Device|InTENsity MicroCombo|An electrotherapy device.
15987320|NCT02983253|Other|blood sample|none, only laboratory tests on blood serum
15987321|NCT02983240|Device|Electrical Uterine Pacemaker|The catheter is placed under ultrasound guidance into the posterior vaginal fornix next to the external cervical os. The electrode connectors are attached to the EI device. Activating the EI device involves: 1) turning the current pulse duration rotary dial clockwise to the desired setting; this is an important setting and should be set at 20ms; 2) turning the current frequency rotary dial clockwise to the desired setting; 3) turn on the EI device on with the on/off toggle switch; 4) SLOWLY turning the current strength rotary dial clockwise to the desired setting, at this time the red light should be flashing. Usually 5-10mA of current is sufficient, but 20 mA is a maximum. Based on the tocometer recordings the least amount of EI current is given to inhibit the uterine contractions.
15987322|NCT02983227|Drug|GDC-0853|GDC-0853 was administered orally at a dose of 200mg, as per the dosing schedules described above.
15987323|NCT02983214|Drug|Clopidogrel|
15987324|NCT02983214|Drug|Cilostazol|
15987325|NCT02983201|Other|filiform needle|Patients will receive filiform needle treatment only.During the study period, a maximum of two courses of acupuncture therapy, consisting of 7 sessions each, will be administered. Treatment will be given twice per week. After completing the first course of 7 sessions, there will be a break of one week, at the end of which the second course will commence. Treatment will come to a halt as soon as the pain has totally subsided.
15987326|NCT02983201|Other|thumbtack needle|Thumbtack intra-dermal needle will be applied to selected acupuncture points after filiform needle treatment. The thumbtack needle will remain embedded in the patient's dermal part for 2-3 days as per instruction.During the study period, a maximum of two courses of acupuncture therapy, consisting of 7 sessions each, will be administered. Treatment will be given twice per week. After completing the first course of 7 sessions, there will be a break of one week, at the end of which the second course will commence. Treatment will come to a halt as soon as the pain has totally subsided.
15987327|NCT02983188|Drug|Berberine|Berberine tablets, 0.3g every time, two times daily
15987328|NCT02983188|Drug|Placebos|Placebo tablets, 0.3g every time, two times daily
15987477|NCT02982226|Other|Corticosteroid Injection|Corticosteroids are considered a standard of care for treatment of Plantar Fasciitis
15987329|NCT02983188|Drug|Antipsychotic Agents|Antipsychotic agents prescribed at the discretion of the patients' psychiatrists with respect to patients' conditions. Concomitant use of other psychotropic drugs, including antidepressants, anxiolytics, and mood stabilizers for mood disorders, benzodiazepines and non-benzodiazepines for insomnia, and anticholinergics for extrapyramidal symptoms, was allowed as usual. For those who were under anti-hyperlipidemic, antihypertensive and anti-diabetic treatment, they were allowed to continue their current medications throughout the study.
15987330|NCT02983175|Other|ultrasound assessment of gastric content|"Achievement of gastric ultrasound (specific procedure) :
~Gastric ultrasound is performed specifically for the study by a senior anesthetist physician in a patient placed supine, semi-sitting by an angle of 45 ° relative to the horizontal.
~Standardised achievement of the antral ultrasound by the following method:
~First, a qualitative assessment of antral contents in 3 grades according to the Perlas method [24].
~Second, performing a quantitative analysis of antral contents calculating the CSA.
~Then, volume of gastric contents calculation as from the CSA."
15987331|NCT02983149|Device|Double lumen tube|Use an double lumen tube to achieve one lung ventilation in thoracic surgeries
15987332|NCT02983149|Device|Fuji blocker|Use the Fuji blocker to achieve one lung ventilation in thoracic surgeries
15987333|NCT02983149|Device|EZ blocker|Use the EZ blocker to achieve one lung ventilation in thoracic surgeries
15987334|NCT02983136|Behavioral|Dialogue and inter-professional learning|"The middle and front-line leaders of the study OR will participate in an intervention based on an iKT model. Components of the intervention will include:
~Two workshops, consisting of educational sessions covering the state of the art regarding person-centeredness, prevention of infections, leadership, and implementation. The educational component and results of pre-studies will work as frameworks for the dialogues between the front-line leaders and the research group. In dialogues the participants will be given the opportunity to reflect on barriers to and enablers of change; and
~The participants will be supported in creating an action plan aimed at facilitating the anaesthesia providers' change of practice."
15987335|NCT02983123|Procedure|1-hour hs-cTnT|
15987336|NCT02983110|Procedure|Anoscopy with Rectal Tissue Sampling|All subjects will provide 10 pieces of rectal tissue
15987337|NCT02983110|Procedure|Phlebotomy|• Procedure: Blood plasma/serum collection Approximately 17 mL of blood will be taken from each subject just prior to tissue sampling.
15987338|NCT02983110|Procedure|Female Genital Tract Sampling|Cohorts B only will have cervical cells, cervical tissue, and vaginal tissue collected
15987339|NCT02983097|Drug|Rituximab|Rituximab 375 mg/m²
15987340|NCT02983097|Drug|Cisplatin|Cisplatinum 100 mg / m²
15987341|NCT02983097|Drug|Carboplatin|Carboplatinum AUC5
15987342|NCT02983097|Drug|Dexamethasone|Dexamethasone 40 mg
15987343|NCT02983097|Drug|Cytarabine|Cytarabine 2000 mg/m², administered twice
15987344|NCT02983097|Drug|Lenalidomide|5-20 mg administered either d1-d7, or d-6-d7
15987345|NCT02983097|Drug|PegFilgrastim|PegFilgrastim 6 mg
15987346|NCT02983097|Procedure|peripheral stem cell collection|collection of peripheral stem cells for autologous stem cell transplantation
15987347|NCT02983084|Device|Orthodontic archwire|Archwire used to align teeth in an orthodontic fixed appliance
15987348|NCT02983071|Drug|G1T38|
15987349|NCT02983071|Drug|Fulvestrant|
15987350|NCT02983058|Radiation|PET/SPECT Scan|PET scan will be performed on a mCT scanner
15987351|NCT02983058|Device|MRI Scan|Structural MRI will be obtained to permit co-registration of PET images
15987352|NCT02983045|Drug|Combination of NKTR-214 + nivolumab|Patients with select tumor types will receive NKTR-214 doses administered either q3w or q2w, in combination with 240 mg nivolumab q2w or in combination with 360 mg of nivolumab q3w.
15987353|NCT02983045|Drug|Combination of NKTR-214 + nivolumab|Select patient cohorts with select tumor types will be dosed with NKTR-214 + nivolumab at the RP2D + other anti-cancer therapies per institution standard.
15987354|NCT02983045|Drug|Combination of NKTR-214 + nivolumab + ipilimumab|Combination of NKTR-214 at 0.006 mg/kg q3w in combination with nivolumab and ipilimumab in up to three different dosing schedules to identify dose and schedules that will proceed into Part 4.
15987355|NCT02983045|Drug|Combination of NKTR-214 + nivolumab + ipilimumab|Combination of NKTR-214 + nivolumab + ipilimumab will be administered at the RP2D dose/schedule in patient cohorts with select tumor types.
15987356|NCT02983032|Behavioral|BBTI|3 group sessions over 4 weeks
15987357|NCT02983019|Drug|Kagocel|Investigators could prescribe other drugs in frame of routine clinical practice
15987360|NCT02982980|Procedure|Physiotherapy Guidance|Pre and postoperative assessment and orientation, guidelines for lymphedema prevention and self drainage, follow-up for rehabilitation or maintenance of joint amplitude of shoulder movements and functional return.
15987361|NCT02982980|Procedure|Physiotherapy Muscle strengthening|The exercises performed were active-free, with the aid of a stick or resistance by elastic bands and dumbbells for flexion, extension, adduction, abduction, external and internal rotation of the shoulder, and elbow flexion and extension, besides activities to enable movements Functional. The mode of execution of the exercises was isotonic, done slowly and within the joint amplitude reached by the patient, using resistance according to the muscular capacity of each patient.
15987362|NCT02982967|Other|Physical Activity|Recreational Physical Activity (Duration: 60 minutes; Intensity: 65%-85% heart rate reserve; Frequency: 4 sessions/week).
15987363|NCT02982954|Drug|Nivolumab|Specified dose on specified day
15987364|NCT02982954|Drug|Ipilimumab|Specified Dose on Specified Day
15987365|NCT02982941|Drug|Enoblituzumab|enoblituzumab administered IV weekly for up to 96 weeks
15987366|NCT02982915|Biological|Longeveron Mesenchymal Stem Cells (LMSCs)|Intravenously delivered
15987367|NCT02982915|Biological|Fluzone High Dose Vaccine|Intramuscular injection
15987368|NCT02982902|Biological|CMV specific adoptive t-cells|It is expected that the cell dose will be in the range of 10^3 - 10^5 virus - specific, antigen selected T cells per kg of recipient weight.
15987369|NCT02982889|Drug|LIQ865A bupivacaine formulation|single subcutaneous injection in medial calf
15987373|NCT02982876|Procedure|Dynamic Flexible Bronchoscopy|The bronchoscope will be introduced into the proximal trachea at the level of the cricoid. At that point, patients will be instructed to take a deep breath, hold it and then blow it out (forced expiratory maneuver). Maneuvers will be done at the following six sites: proximal trachea at the level of the cricoid; mid-trachea 5 cm proximal to the carina; distal trachea 2 cm proximal to the carina; right main stem bronchus at the right tracheobronchial angle; bronchus intermedius and left main bronchus at the left tracheobronchial angle
15987374|NCT02982876|Procedure|Rigid Bronchoscopy|Under general anesthesia, a rigid bronchoscope (Bryan-Dumon Series II; Bryan Corporation; Woburn, MA) will be introduced, and respiration will be maintained through jet ventilation.
15987375|NCT02982876|Device|Stent placement|Silicone Y stent or uncovered self-expanding metallic stent will be placed in the standard fashion and good fit will be confirmed visually.
15987376|NCT02982850|Drug|Dabigatran|
15987377|NCT02982850|Drug|Acetylsalicylic acid|
15987378|NCT02982850|Drug|Warfarin|
15987379|NCT02982837|Drug|PEG-IFN & Nucleos(t)tide analogues|Subjects who will be randomized to receive 180 Mcg/ week as an add-on Pegylated Interferon therapy α-2 A with their ongoing NUCLEOTIDE analogues for 48 weeks.
15987380|NCT02982837|Drug|Nucleos(t)tide analogues|Subjects will continue on the same dose of Nucleoside/nucleotide analogues as they started the study.
15987381|NCT02982824|Dietary Supplement|Magnesium|Oral magnesium
15987382|NCT02982824|Drug|Placebo - Concentrate|Placebo will be given
15987383|NCT02982811|Device|i-ACT|3x 45 min training with i-ACT system (analytical and functional training) during 6 weeks, additional to therapy as usual (i.e. occupational therapy, physiotherapy, etc.)
15987384|NCT02982798|Drug|Metformin + Rosuvastatin|administration of Metformin + Rosuvastatin
15987385|NCT02982798|Drug|JLP-1310|administration of JLP-1310
15987386|NCT02982785|Behavioral|Standard post-operative rehabilitation|
15987387|NCT02982772|Other|Combination Therapy|"Brief behavioral intervention
~The test product is a transdermal nicotine patch for 12 weeks. The dosage of the test product depends on the new algorithm (amount, addiction, prior attempts) Nicotine Gums for 12 weeks."
15987388|NCT02982772|Other|Standard Care Intervention|"Brief Behavioral Intervention
~The test product is transdermal Nicotine replacement patch for 10 weeks.The dosage of the test product follows the product guidelines and depends on the amount of cigarettes used.
~Standard Flavored Gums for 10 weeks"
15987389|NCT02982759|Behavioral|Multi-Level Intervention|The multi-level interventions will include activities at the individual level, family level, school level, and community level.
15987390|NCT02982759|Behavioral|Genetic Newsletters|The comparison will receive generic newsletters
15987391|NCT02982746|Other|gPCC (Gothenburg Person Centred Care)|
15987392|NCT02982733|Other|ABS|Ankaferd Blood Stopper
15987393|NCT02982733|Device|TR Band|Transradial band
15987394|NCT02982733|Other|CS|Sterile Gauze
15987395|NCT02982720|Drug|Pembrolizumab|Pembrolizumab will be administered intravenously.
15987396|NCT02982720|Drug|Sylatron|Sylatron will be administered subcutaneously.
15987397|NCT02982707|Drug|BMS-986177|Single oral dose
15987398|NCT02982694|Drug|Atezolizumab|Atezolizumab will be administered 1200 mg in 250 ml 0.9% NaCl IV infusion bag, on day 1 of each cycle of 21 days.
15987399|NCT02982694|Drug|Bevacizumab|Bevacizumab will be administered 7.5 ml/kg (diluted in 0.9% sodium chloride solution) on day 1 of each 21 days cycle.
15987400|NCT02982681|Drug|Platelet rich fibrin|In the test site the graft was then carefully compacted from the base of the defect coronally. PRF membrane was placed in the test site
15987401|NCT02982681|Drug|Bioactive Glass|The control site were packed with the bioactive glass graft alone
15987402|NCT02982668|Other|Initial enteral feeding|
15987403|NCT02982668|Drug|erythromycin|gastrointestinal (GI) motility improving
15987404|NCT02982655|Procedure|Individualized BP lowering|
15987405|NCT02982642|Drug|1612 capsule|Subjects will be assigned 1612 capsule,3 capsules per time(0.38g per capsule), 3 times per day.1612 capsule is a Chinse herbal medicine,which can tonification of spleen and kidney, mainly contains shudihuang(Rehmannia glutinosa),shanyao(Dioscorea opposita),shichangpu(Uncaria rhynchophylla)and so on,
15987406|NCT02982642|Drug|Placebos|Subjects will be assigned placebo identified to 1612 capsule,3 capsules per time, 3 times per day
15987407|NCT02982629|Behavioral|Reminder letter Intervention|Patients in this group receive letters and phone calls to reschedule missed follow-up appointments.
15987408|NCT02982616|Dietary Supplement|Dodecanoic acid|The middle chain saturated fatty acid that can be widely found in daily food.
15987409|NCT02982616|Behavioral|Positive emotion|Positive emotion induced by facial expressions and classic music.
15987410|NCT02982616|Dietary Supplement|saline|saline
15987411|NCT02982616|Behavioral|neutral emotion|Neutral emotion induced by facial expressions and classic music.
15987412|NCT02982603|Drug|Qinggongshoutao Bolus|Qinggongshoutao bolus and placebo identified to Ginkgo Biloba Extract 761
15987413|NCT02982603|Drug|Ginkgo Biloba Extract 761|Placebo identified to Qinggongshoutao bolus and Ginkgo Biloba Extract 761
15987414|NCT02982603|Drug|Placebos|Placebo identified to Qinggongshoutao Bolus and placebo identified to Ginkgo biloba
15987415|NCT02982590|Drug|Apixaban 5 MG Oral Tablet [ELIQUIS]|Apixaban is licensed for treatment of deep vein thrombosis and pulmonary embolism. Hence, a good study drug for left ventricular thrombosis for possibility of a new indication.
15987416|NCT02982590|Drug|Warfarin Sodium|as controlled arm since warfarin is the standard therapy for LV thrombus
15987417|NCT02982577|Drug|Pilocarpine|Spray the basis of 1.54% pilocarpine, 3 times per day (each 8 hours), during 90 days.
15987418|NCT02982577|Other|Spray without Pilocarpine|Spray without pilocarpine, 3 times per day (each 8 hours), during 90 days.
15987419|NCT02982564|Behavioral|Exercise Program Low Intensity|This arm includes a low-intensity intervention and will have a duration of six months. Participants will be provided with a heart rate monitor to train at the intensity according to group assignment. Progression for both programs in the endurance component will be slower and more gradual for deconditioned participants, and may require multiple shorter periods (5-10 minutes) with rest intervals.
15987476|NCT02982226|Other|ReNu Injection|ReNu is an allograft tissue composed of particularized amniotic membrane and cell from the amniotic fluid.
15987420|NCT02982564|Behavioral|Exercise Program Moderate Intensity|This arm includes a moderate-intensity intervention and will have a duration of six months. Participants will be provided with a heart rate monitor to train at the intensity according to group assignment. Progression for both programs in the endurance component will be slower and more gradual for deconditioned participants, and may require multiple shorter periods (5-10 minutes) with rest intervals.
15987421|NCT02982551|Drug|Insulin|Insulin will be administered peripherally to observe the effects of circulating insulin on brain activity
15987422|NCT02982551|Other|Taste Task|Participants will taste milkshakes and a tasteless solution to observe the brain responses to palatable taste.
15987423|NCT02982551|Other|Magnetic Resonance Imaging|Participants will complete two MRI scans approximately 60 minutes apart - one under baseline fasting conditions and the second during isoglycemic-hyperinsulinemia. Each functional scan will include a resting-state BOLD sequence followed by a taste-reward task. Functional MRI sequences will last approximately 30 minutes. MRI scanning will also include approximately 30 minutes of structural MRI scans.
15987424|NCT02982551|Drug|Dextrose|During hyperinsulinemic clamp, participants will be infused with a variable rate dextrose infusion will be used to keep the blood sugar level within 5mg/dl of the baseline glucose value.
15987425|NCT02982538|Behavioral|Extended Training in Prolonged Exposure Therapy for PTSD|Extended training in Prolonged Exposure consists of a 4-day PE workshop, followed by expert PE consultation on 2 training cases. PE consultation consists of weekly telephone calls with expert PE therapists at the University of Pennsylvania, who will review video-recordings of providers PE sessions and provide feedback. Consultation is considered complete if the consultant has reviewed a minimum of 12 video-recorded sessions across 2 training cases, and has provided feedback on all of the crucial elements of PE (e.g., rationale, imaginal exposure, in vivo exposure, processing).
15987426|NCT02982538|Behavioral|Standard Training in Prolonged Exposure Therapy for PTSD|Standard training in PE consists of a 4-day professional workshop on Prolonged Exposure Therapy. This is similar to the standard training approach that has been used to train providers in delivery of PE in the Army.
15987427|NCT02982525|Dietary Supplement|No Mussels|Habitual diet only
15987428|NCT02982525|Dietary Supplement|One mussel portion|1 x 75g mussel portions provided per week
15987429|NCT02982525|Dietary Supplement|Two mussel portions|2 x 75g mussel portions provided per week
15987430|NCT02982525|Dietary Supplement|Three mussel portions|3 x 75g mussel portions provided per week
15987431|NCT02982512|Drug|Dexmedetomidine|Administration of dexmedetomidine a different concetrations
15987432|NCT02982499|Device|magnetic resonance image (MRI)|Radiographic imaging that takes about 30-45 minutes
15987433|NCT02982499|Device|Optical Coherence Tomography (OCT)|Images taken from the back of the eye (retina)
15987434|NCT02982486|Drug|Ipilimumab|Ipilimumab 1 mg/kg every 6 weeks
15987435|NCT02982486|Drug|Nivolumab|Ninolumab 240 mg IV every 2 weeks
15987436|NCT02982460|Other|Isoinertial + eccentric exercise|A session of isionertial + eccentric exercise covers the activity, strength and endurance of scapular muscles.
15987437|NCT02982460|Other|Eccentric exercise|A session of eccentric exercise covers the strength of scapular muscles.
15987438|NCT02982447|Device|blue laser imaging colonoscopy|Insertion to cecum was performed under white light(WL) and once the cecum was reached, the Blue Laser Imaging mode was switched on during withdrawal of endoscope for complete colonic examination. Second colonoscopic examination was performed in a similar manner after the first complete withdrawal of the colonoscope. WL was used on insertion and WL was used on withdrawal
15987439|NCT02982447|Device|conventional white light colonoscopy|In this arm, WL was used for both insertion and withdrawal of the colonoscope during the first-pass and second-pass examinations.
15987440|NCT02982434|Drug|Pharmaceutical composition containing botulinum toxin|
15987441|NCT02982434|Drug|0.9% normal saline|
15987442|NCT02982434|Procedure|Coronary artery bypass grafting|
15987443|NCT02982421|Behavioral|Group art therapy|Participants will engage in an art therapy group tailored at emotion expression related to the experience of breast cancer survivorship.
15987444|NCT02982421|Behavioral|Control|Participants will receive Psychoeducational material in the form of a lecture and will engage in the coloring of mandalas.
15987445|NCT02982408|Dietary Supplement|High carbohydrate overfeeding|"All participant's individual energy requirement will be determined in mega joules (MJ) per day. The energy requirement will be multiplied by a factor 1.5 for a low physical activity level (PAL). The MJ will be rounded up or down to the nearest whole number.
~The participant will receive food corresponding to ~25% additional energy above their calculated energy requirement. The 25% extra energy will be supplied to the participants for 4 weeks in the form of food containing simple carbohydrates. The subjects will be given a daily snack package containing processed foods or refined foods such as sweets, cookies, soft drinks, juice etc. To ensure an adequate energy surplus (i.e. weight gain), physical activity has to be decreased to a low level during the 4 weeks overfeeding period."
15987446|NCT02982408|Behavioral|Exercise|"Half of the participants will be randomized to a 3-month exercise-training program.
~The training program consists of combined aerobic training and strength training. The training program is performed unsupervised 3 times per week 45 minutes per session for 3 months in the local fitness center. Before engaging in the training program a maximal oxygen consumption test (VO2 max) are conducted and the maximal heartrate (HR) are determined.Participants are wearing the Polar V800 HR monitor and are asked to note their HR in a training log at the end of the last interval at each training session. The strength training program consist of 6 exercises (2 exercises paired together) involving the large muscle groups. The first training session is completed supervised at Rigshospitalet . After 6 weeks the training program is adjusted. Compliance will be ensured by phone calls, text messages and e-mails from study personnel."
15987474|NCT02982239|Other|Information Session|"all 40 participants will attend a 1-hour information session about sleep delivered by the PIs, to be followed by a 1-hour Q&A period.
~Peer educators will receive and extra 1-hour training session on how to handle questions and when to refer back to the PIs."
15987475|NCT02982239|Behavioral|Text messages|All participants will receive text messages in the evening that will include adherence reminders, encouraging statements, and tips for improving sleep. Messages will be randomized, with no more than 3 messages of any type per week. Messages will serve as a cue to action without being overly repetitive or predictable.
15987519|NCT02981940|Procedure|Surgery|Surgery
15987447|NCT02982408|Behavioral|Normal physical activity|"The other half of the participants will be randomized to a 3-month with normal physical activity level (control).
~The participants will have to return to the physical activity level they had before entering the study (baseline level). Compliance will be ensured by phone calls and text messages from study personnel. The subjects will wear a simple pedometer on the hip showing the number of steps. Once a week a text message (SMS-track) is automatically sent asking the participants to enter the weekly number of steps. The test personnel receive the reply and contact the participant if the number of steps does not match the baseline level. During the first and the last 7 days of the exercise intervention participants are wearing 2 accelerometers measuring their physical activity behavior."
15987448|NCT02982395|Drug|Nanoxel®M|Intravesical
15987449|NCT02982395|Drug|Mitomycin-C|Intravesical
15987450|NCT02982382|Other|Manipulative Therapy|Subjects will receive techniques of High Velocity and Low Amplitude (HVLA) or grade V manipulation to the lumbar region (lumbar roll), and pain education based on the biopsychosocial approach.
15987451|NCT02982382|Other|Pain Education|Individuals will receive pain education based in a biopsychosocial approach
15987452|NCT02982382|Other|Sham|The individuals will receive a simulation of spinal manipulation (sham) involving manual contact over lumbar region totaling 5 minutes.
15987453|NCT02982369|Other|Spinal Manipulation|High-velocity and low-amplitude (HVLA) manipulation techniques to the cervical and thoracic region
15987454|NCT02982369|Other|Pain Education|Subjects will receive pain education based in biopsychosocial approach
15987455|NCT02982369|Other|Sham|A simulation of spinal manipulation (sham), involving manual contact over the cervical and thoracic region totaling 10 minutes.
15987456|NCT02982356|Procedure|Fetal Selective Reduction Technology|Fetal Selective Reduction Technology will be conducted according to different gestational weeks: before 16weeks, 16~24 weeks, 24~27+6 weeks,>28weeks
15987457|NCT02982356|Drug|Potassium Chloride|
15987458|NCT02982343|Behavioral|Falls management plus exercise training|Participants will undergo a session of falls management and education followed by 12 weeks of strength and balance training. Strength training will be performed 4 times per week. Resistance training of the proximal muscles will be prescribed progressing to loads of 60% of 1 repetition maximum, 8-12 repetitions. Weaker muscles will be trained using 2 sets of 8-12 repetitions against gravity. They will also give a selection of exercises targeting balance to challenge stability and sensory feedback using equipment such as foam cushions, though will be individual based on participants' limitations and abilities. Participants will be asked to perform balance exercises daily.
15987459|NCT02982343|Behavioral|Falls management only|Participants will undergo a session of falls management and education.
15987460|NCT02982330|Behavioral|Low Carbohydrate Breakfast|A low carbohydrate breakfast containing <10% carbohydrate, ~75% fat, and 15% protein. Matched for calories to the active comparator arm.
15987461|NCT02982330|Behavioral|Guidelines Breakfast|A low fat breakfast containing ~55% carbohydrate, <30% fat, and 15% protein. Matched for calories to the experimental arm.
15987462|NCT02982317|Procedure|Manual palpation identification lumbar spine|
15987463|NCT02982317|Procedure|Automated ultrasound technology identification|This technology involves a standard ultrasound machine and curvilinear probe- what is novel is the software which will be connected to the ultrasound machine
15987464|NCT02982317|Procedure|Lumbar level identification gold standard ultrasound|
15987465|NCT02982304|Device|Deep Brain Stimulation|Deep Brain Stimulation Electrode
15987466|NCT02982291|Procedure|Williams flexion protocol|The Williams flexion protocol group will participate in 15 treatment sessions.
15987467|NCT02982291|Procedure|Focused spinal stenosis rehabilitation|The focused spinal stenosis rehabilitation group will participate in 5 treatment sessions.
15987468|NCT02982278|Behavioral|Community-based Intervention under Nurse Guidance after Stroke|CINGS is a 12-week nurse coordinated, Community Health Worker intervention structure. Intervention home visits will be conducted by the CHW and will include home-based training in self-care and self-management strategies alongside strategies to address risk of negative stroke outcomes that will be determined once these risk factors are identified and community-engaged approaches to their resolution derived. CHW efforts will be guided via televideo interactions with nurse coordinator. During home-visits, self-reported assessments will be collected via RedCap as well as assessments collected by the CHW and research nurse (weight, blood pressure, medication adherence). After baseline, participants randomized to the intervention group will have home visits, once a week for the first month, and biweekly for the other two months, conducted by the CHW. Additionally, there will be post-intervention follow-up assessments at 3, 6, and 12-month time intervals.
15987469|NCT02982252|Behavioral|CoPILOT|Participants in all groups will receive either six or twelve hours of training in a standard powered wheelchair; however, the CoPILOT groups will use remote control technology we have developed. The technology provides the trainer with remote control of wheelchair speed and direction allowing the trainer to override the participant's actions as needed to ensure safe error-free shared controlled wheelchair training. The CoPILOT approach will accommodate varied learning needs, as per adult learning principles, while decreasing trainer input until the participant can complete tasks independently.
15987470|NCT02982239|Behavioral|Sleep Diary|All 40 chosen students will be provided a link to complete a daily sleep diary for 10 weeks. Sleep diary will assess activity before bed, bedtime, time to fall asleep, number of awakenings, time awake after sleep onset, time out of bed, time of final awakening, perceived sleep quality. Diary also asks about naps taken during the day, caffeine and tobacco consumption, and an additional space for open-ended comments from the participant.
15987471|NCT02982239|Device|Fitness tracker|All 40 chosen students will receive a fitness tracker. The fit bit will estimate sleep and physical activity as well as adherence to the program. participants will have access to their own data. Data will also be monitored from the lab using Fitabase which provides access to day, hour, and minute-level resolution of data for steps taken, intensity class, calories burned, and sleep (length, movement, and quality).
15987472|NCT02982239|Device|Blue-Blocking Glasses|Half of the 40 chosen students (N=20) will be provided with blue blocking glasses. The blue-blocking glasses will ensure that blue light from electronic devices will not interfere with circadian rhythm or sleep onset, and allow students to fall asleep earlier.
15987473|NCT02982239|Device|LED light|Half of the 40 chosen students (N=20) will be provided with a bright LED light. The bright LED light will provide bright blue light in the morning to help students wake and an amber light to promote earlier bedtimes.
15987478|NCT02982213|Other|Companion Present|A companion will be present during the epidural catheter placement.
15987479|NCT02982187|Device|Placebo ELLIPTA|It is a dry powder inhaler device that can hold two individual blisters: one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate.
15987480|NCT02982187|Device|Placebo DISKUS|It is a placebo dry powder inhaler with one blister strip containing lactose monohydrate.
15987481|NCT02982187|Device|Placebo TURBUHALER|It is a placebo dry powder inhaler containing lactose monohydrate.
15987482|NCT02982187|Device|Placebo HANDIHALER|Placebo capsules contain lactose monohydrate in the form of powder for oral inhalation, to be used with HANDIHALER device.
15987483|NCT02982187|Other|PQ1|Consists of 2 questions to assess subjects' preference of device attributes and dosing regimens. The 4 versions of the questionnaire ask the same questions, but differ in the ordering of inhalers in their responses.
15987484|NCT02982187|Other|PQ2|Consists of 2 questions to assess subjects' preference of device attributes and dosing regimens. The 4 versions of the questionnaire ask the same questions.
15987485|NCT02982187|Other|PQ3|Consists of 2 questions to assess subjects' preference of device attributes and dosing regimens. The 4 versions of the questionnaire ask the same questions.
15987486|NCT02982187|Other|PQ4|Consists of 2 questions to assess subjects' preference of device attributes and dosing regimens. The 4 versions of the questionnaire ask the same questions.
15987489|NCT02982161|Drug|MR308|Over-encapsulated tablet, Dosing frequency: two times daily, Mode of administration: oral
15987490|NCT02982161|Drug|Tramadol|Over-encapsulated capsule, Dosing frequency: four times daily, Mode of administration: oral
15987491|NCT02982161|Drug|Placebo|Capsule, Dosing frequency: four times daily, Mode of administration: oral
15987492|NCT02982148|Device|methylene blue intradermal injection|Methylene blue has been prove to be effective and safe as a blue dye for sentinel lymph node biopsy in early breast cancer patient. But it was also reported by some article that adverse skin lesions appeared after methylene blue injections for sentinel lymph node localization. But the effectiveness and safety of methylene blue intradermal injection has not yet been investigated.
15987493|NCT02982148|Device|methylene blue subcutaneous injection|Methylene blue subcutaneous injection has become one of the standard method for sentinel lymph node biopsy for breast cancer patients. In such case, we use this method to be an active comparator for the intradermal injection group.
15987494|NCT02982135|Other|bypass surgery and indrect bypass surgery|bypass surgery ： patients recieved STA-MCA bypass indrect bypass surgery：patients recieved EDAS or mutiple bur holes
15987495|NCT02982122|Other|For both groups, CPP targets will be achieved first by ICP control if this is raised and then by ABP support by titration (up or down) of vasopressors and fluids according to local protocols.|For both groups, CPP targets will be achieved first by ICP control if this is raised and then by ABP support by titration (up or down) of vasopressors and fluids according to local protocols.
15987496|NCT02982096|Device|Cellutome Device|Use of FDA approved Cellutome treatment on burn wounds
15987497|NCT02982096|Other|Standard of Care|Acellular burn wound management
15987498|NCT02982083|Drug|Raloxifene hydrochloride|20 patients consume raloxifene hydrochloride oral tablet daily for one year.
15987499|NCT02982083|Drug|Placebo Oral Tablet|20 patients consume placebo oral tablets daily for one year.
15987500|NCT02982070|Behavioral|Mental Toughness Training|Behavioral training in goal-building, mindfulness, and the growth mindset.
15987501|NCT02982057|Device|the ABSORB:bioresorbable vascular scaffold|
15987502|NCT02982057|Drug|O.M.T|
15987503|NCT02982044|Other|Suprasystolic (300 mmHg) cuff compressions|10 minutes of ECG-gated repeated suprasystolic (300 mmHg) cuff compressions, with inflation occurring every other heart cycle. These cuff compressions may be triggered 0 seconds, 0.2 seconds, or 0.4 seconds from the R spike (systole) on the ECG signal.
15987504|NCT02982044|Other|Handgrip exercise|10 minutes of ECG-gated rhythmic handgrip exercise at 30% maximal voluntary contraction, with contraction occurring every other heart cycle
15987505|NCT02982044|Other|Passive heat stress|10 minutes of passive heat stress at 42 degrees Celsius with a commercially available heating blanket
15987506|NCT02982031|Procedure|shamrock|This scanning technique is performed in the lateral decubitus position with the side of interest facing upwards. The transducer is placed in the transverse plane on the flank of the patient cranially to the iliac crest. The quadratus lumborum muscle is identified medial to the aponeurosis of the transversus abdominis muscle. With the psoas muscle anterior to the transverse process, the erector spinae muscle posterior to the transverse process, and the quadratus lumborum muscle attached to the apex of the transverse process of L4.
15987507|NCT02982031|Procedure|paramedian transverse scan|The ultrasound transducer is positioned 4 cm lateral to the midline along the intercristal line and just above the iliac crest. The transducer is also directed slightly medially.
15987508|NCT02982018|Device|senofilcon A with new UV blocker|Investigational Contact Lens
15987509|NCT02982018|Device|senofilcon A|J&J Marketed Contact Lens
15987510|NCT02982005|Drug|KHK4827|Administered KHK4827 by subcutaneous (SC) injection until week 62.
15987511|NCT02982005|Drug|Placebo|Administered placebo by subcutaneous (SC) injection until week 12. Administered KHK4827 by SC injection from week 13 until week 62.
15987512|NCT02981979|Drug|Leflunomide 10mg Tab|20mg per day for leflunomide group during the entire study; 20mg per day for control group during the maintenance therapy (start from the 25th week till the end of the study).
15987513|NCT02981979|Drug|Prednisone Acetate|basic therapy（start with 0.6mg/kg/d and maintained for 4 weeks, then reducing 5mg every 2 weeks until 10mg per day if the subject achieve clinical remission.）
15987514|NCT02981979|Drug|Placebos|used in control group during the induced remission therapy for 24 weeks.
15987515|NCT02981966|Drug|Dapagliflozin|dapagliflozin, 10mg tablet
15987516|NCT02981966|Drug|Placebo|Placebo for dapagliflozin
15987517|NCT02981953|Device|Cardioband Tricuspid|The Cardioband Adjustable implant is delivered and anchored to the tricuspid valve annulus by a transfemoral delivery system. The Cardioband TR will be deployed and adjusted under trans-esophageal and fluoroscopy guidance.
15987518|NCT02981940|Drug|Abemaciclib|Abemaciclib capsule
15987521|NCT02981914|Drug|Pembrolizumab|Pembrolizumab will be administered at a fixed dose of 200 mg IV every 3 weeks for a max of 24 months, so long as there is no disease progression.
15987522|NCT02981901|Other|Patient with ovarian epithelial cancer|
15987523|NCT02981888|Radiation|X-Ray|X-ray of the abdomen will be performed to assess colonic transit
15987524|NCT02981875|Other|oculomotor training|a sequence of vision training exercises which focused mainly in oculomotor skill
15987525|NCT02981875|Other|placebo|placebo vision training exercises involving minimal accommodation and vergence eye movement.
15987526|NCT02981862|Other|CaptHPV method|"20 ml of blood sample will be made before the beginning of all treatment. This blood sample will be sent to the CERBA Laboratory for analysis.
~In parallel, a standard anatomopathological and virological analysis will be carried out from a biopsy or from a tumor sample by the Tumor Biology Unit at Lorraine Institute of Oncology
~The results of both analyzes will be compared blindly."
15987527|NCT02981836|Biological|Investigational live attenuated varicella vaccine|The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
15987528|NCT02981836|Biological|diluent of lyophilized vaccine|The diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
15987529|NCT02981823|Procedure|hip replacement|The patients undergo hip replacement with the collum femoris preserving stem suffered from periprosthetic fractures.
15987530|NCT02981810|Device|Arthrocare® Corporation (ArthroCare Corporation, 7500 Rialto Boulevard Austin, Texas 78735) COBLATION electrode ReFlex Ultra 55*|The treatment was conducted using an Arthrocare® Corporation (ArthroCare Corporation, 7500 Rialto Boulevard Austin, Texas 78735) COBLATION electrode ReFlex Ultra 55* for tonsillar tissue ablation at low temperatures with only one treatment. All the patients underwent tonsil channeling treatment with coblation, and 4-6 channels were done in each tonsil under local anesthesia, in the operating room. The patients were observed overnight.
15987531|NCT02981810|Procedure|tonsillectomy|
15987532|NCT02981797|Other|Blood Collection During Standard of Care Treatment|Blood collection for baseline CTC numeration and H2AX assay. Circulating prostate cancer cell analysis requires blood draw of 7.5 ml (about 1 ½ teaspoons) of blood, to be performed at the screening, 1-2 hours before the third and sixth dose of radium 223 and 24 hours after the first, third, sixth dose of Radium 223. Standard of care Radium 223 treatment is given every 4 weeks for a total of 6 treatments and post Radium 223 follow up at week 24 is also considered standard of care. Other than these standard clinic visits and treatments, the study only requires 3 extra trips to the cancer center for blood draw at 24 hours after the first, third, sixth dose of Radium 223. Blood draws other than circulating tumor cell analysis is considered standard of care and doesn't require extra visits.
15987533|NCT02981784|Drug|Ponatinib (Iclusig®)|Novel tyrosine kinase inhibitor active in patients with an ABL T315I mutation compared to conventional or reduced intensity allogeneic stem cell transplantation.
15987534|NCT02981784|Procedure|allogeneic stem cell transplantation|
15987535|NCT02981771|Behavioral|Balance activity program|Participants will take part in a biweekly, 12 week physical activity program that will include balance and coordination exercises
15987536|NCT02981771|Behavioral|Strength activity program|Participants will take part in a biweekly, 12 week physical activity program that will include traditional strength exercises
15987537|NCT02981745|Drug|CT-1530|Relapsed or Refractory B Cell Non-Hodgkin Lymphoma, Chronic Lymphocytic Leukemia, Waldenstrom's Macroglobulinemia, FL, Diffuse B-cell lymphoma, Mental-cell lymphoma
15987538|NCT02981732|Other|Liuwei Dihuang Pill|
15987539|NCT02981719|Procedure|simultaneous gemcitabine and irreversible electroporation|gemcitabine intravenous infusion prior to irreversible electroporation treatment
15987540|NCT02981719|Procedure|irreversible electroporation|percutaneous irreversible electroporation was performmed for locally advaanced pancreatic cancer.
15987541|NCT02981706|Procedure|Arteriovenous Fistula (AVF)|The location of vascular access placement in the upper extremity will be based on pre-surgery vein mapping and the appearance of the vessels at the time of the surgery, with the most distal clinically acceptable location used. When no contra-indication is present, the vascular access will be placed in the non-dominant arm per standard of care. In this case, the vascular access will be an arteriovenous fistula, or connection between a native artery and vein.
15987542|NCT02981706|Procedure|Arteriovenous Graft (AVG)|The location of vascular access placement in the upper extremity will be based on pre-surgery vein mapping and the appearance of the vessels at the time of the surgery, with the most distal clinically acceptable location used. When no contra-indication is present, the vascular access will be placed in the non-dominant arm per standard of care. In this case, the vascular access will be an arteriovenous graft, or synthetic connection between a native artery and vein.
15987543|NCT02981693|Procedure|Root canal sealer|Patients who required root canal therapy were enrolled and allotted into either iRoot SP arm or AH Plus arm randomly.For Test Arm: iRoot SP was used as a sealer. Obturation was performed with Gutta-percha cones and root canal sealer by continuous-wave condensation technique. For Control Arm: AH Plus was used as root canal sealer. The same steps were followed for obturation as in Test Arm.
15987544|NCT02981680|Procedure|Remote Ischemic Preconditioning (RIPC)|Remote ischemic preconditioning (RIPC) is a phenomenon in which brief ischemia of one organ or tissue, provokes a protective effect that can reduce the mass of infarction caused by vessel occlusion and reperfusion.
15987545|NCT02981680|Procedure|sham-RIPC|
15987546|NCT02981667|Other|Exercise intensity|Participants were randomized to 1 or 2 exercise intensities, moderate or high (interval training).
15987547|NCT02981654|Device|Alma Lasers Pixel carbon dioxide laser system|The vaginal handpiece sheath is lubricated with baby oil. Set the initial energy level (startup set up recommendations: High mode, 40 millijoule/pixel; according to the patient reaction you can increase up to 120 max. Pulse mode or Repeat mode). The handpiece is inserted as distally as possible, with the laser energy's window oriented to the 12:00 o'clock position. There are position markings on the handpiece. Trigger a laser pulse by pressing the footswitch. Shoot the laser and rotate the probe by one hour at a time. When you reach the 12:00 o'clock position again, withdrawal the headpiece back by one centimeter and repeat the rotational treatment process.
15987548|NCT02981641|Radiation|Intraoperative radiotherapy (IORT)|Total dose: 18~22 Gy; Single dose: 18~22 Gy; Frequency: 1
15987549|NCT02981641|Drug|Sequential chemotherapy|Sequential chemotherapy
15987634|NCT02981069|Drug|Exenatide|Byetta 5 to 10 ug (twice daily) Bydureon 2mg (once weekly)
15987550|NCT02981641|Radiation|Three dimensional conformal radiation therapy (3D-CRT)|Total dose: 60 Gy; Single dose: 2 Gy; Frequency: 30
15987551|NCT02981641|Drug|Concurrent chemotherapy|Gemcitabine (GEM), 800 mg/m2 weekly on Day 1-21, Q28d; or S-1 orally, 400 mg/d, bid on Day 1-21, Q28d
15987560|NCT02981615|Drug|Levofloxacin|one tablet (500mg) a day, from day 10 to day 28 in every cycle of the 4 first cycles
15987561|NCT02981615|Drug|Placebo Oral Tablet|one tablet a day, from day 10 to day 28 in every cycle of the 4 first cycles
15987562|NCT02981602|Drug|IONIS-HBVRx|Ascending multiple doses of IONIS-HBVRx by subcutaneous (SC) injection
15987563|NCT02981602|Drug|Placebo|Placebo
15987564|NCT02981589|Device|Invasive mechanical ventilation|Invasive ventilation was performed to all eligible patients. When patients met predefined criteria, spontaneous breathing trial was performed. Given spontaneous breathing trial passed, patients were extubated; on the contrary, patients would continue to receive invasive ventilation. If patients had respiratory failure after extubation, reintubation and invasive ventilation were necessary.
15987565|NCT02981576|Biological|Autologous Mesenchymal Stem Cells|Autologous Mesenchymal Stem Cells will be collected from patients, prepared in the lab and then injected intrathecally.
15987566|NCT02981563|Other|Time Together|For a fixed time during the day, staff dedicates their time to exclusively engage with the patients. Different activities will be offered to both patients and staff, such as playing board games, taking a walk, or having individual conversations. Other duties of more administrative nature, visits and meetings will be performed at other times during the day. Through this, opportunities for interaction are both created and protected.
15987567|NCT02981537|Device|two-staged endobronchial blocker insertion|positioning endobronchial blockers in two-staged method
15987568|NCT02981537|Device|single-staged endobronchial blocker insertion|positioning endobronchial blockers in traditional single-staged method
15987569|NCT02981524|Drug|CY|CY is administered intravenously at 200 mg/m2
15987570|NCT02981524|Biological|GVAX|GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting
15987571|NCT02981524|Drug|Pembrolizumab|Pembrolizumab is administered intravenously at 200 mg
15987572|NCT02981511|Device|optiflow|Optiflow device used for preoxygenation
15987573|NCT02981498|Procedure|Hepatic arterial infusion chemotherapy|administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
15987574|NCT02981498|Drug|Folfox Protocol|Oxaliplatin , fluorouracil, and leucovorin
15987575|NCT02981485|Device|Fat Grafting|Treatment of breast cancer related lymphedema by fat grafting
15987576|NCT02981472|Drug|Apixaban|Specified dose on specified days
15987577|NCT02981472|Drug|Vitamin K Antagonist (VKA)|Specified dose on specified days
15987578|NCT02981472|Drug|Low Molecular Weight Heparin (LMWH)|Specified dose on specified days
15987579|NCT02981459|Drug|Mirabegron|daily mirabegron 25mg with the option to increase dose based on symptoms to 50mg daily after 4 weeks
15987580|NCT02981446|Drug|DE-117|DE-117 ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
15987581|NCT02981446|Drug|Latanoprost ophthalmic solution|Latanoprost ophthalmic solution will be taken one drop, once daily for 3 months in both eyes.
15987582|NCT02981420|Behavioral|Safety planning|Safety Planning Intervention. This brief one-session intervention, based on cognitive behavioral principles, is designed to help individuals identify a concrete list of coping strategies and social supports that youth can utilize preceding or during a crisis to lower imminent risk of suicidal behavior. In youth who also report nonsuicidal self-injurious behavior (NSSI), the safety plan will address both suicidal and nonsuicidal behavior. The plan helps youth identify possible triggers to SI/crisis including self-monitoring of suicidal thoughts, feelings, and behaviors; advance planning to remove lethal means; determine distress tolerance/emotion regulation skills that may be helpful; identify accessible social supports to target hopelessness/sense of isolation; reinforce the commitment to seek treatment; and, how and where to access emergency care.
15987583|NCT02981407|Biological|Red Blood Cell Transfusion|Transfusion of packed red blood cell units
15987584|NCT02981394|Procedure|Bone Marrow Aspirate Concentrate Injection|BMAC will be collected in the outpatient setting with local anesthesia. The collection site will be the Posterior Superior Iliac Spine (PSIS). This will be visualized under ultrasound prior to collection. Local anesthesia with 1% lidocaine will be performed prior to the harvest. BMAC harvest will be performed using the Arthrex Angel BMAC System using the Arthrex collection protocol. The Arthrex Angel machine will be used to separate BMAC contents for injection based on Arthrex collection protocol. Machine settings, volume of collection and volume of output have not been standardized and will be based upon harvest and the condition treated. These will be variables recorded for consideration of optimal settings based on the patient-reported outcomes.
15987585|NCT02981381|Device|NEST-1|The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of PTSD. The device includes an EEG recording module that is used to record individualized alpha frequency (IAF) on randomized personal passport modules (PPM) pre-assigned to be NEST-1 compatible.
15987586|NCT02981381|Device|SHAM|The SHAM NeoSync EEG Synchronized TMS (NEST) is a device, identical to the active NEST-1 device, that is configured to simulate the delivery of active treatment without actively delivering sTMS therapy. The device includes an EEG recording module that is used to record individualized alpha frequency (IAF) on randomized personal passport modules (PPM) pre-assigned to be SHAM compatible.
15987587|NCT02981381|Device|NEST-2|The open-label NeoSync EEG Synchronized TMS (NEST) that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of PTSD. The device is distinct in both color and sound both SHAM and NEST-1 devices. PPMs corresponding with both SHAM and NEST-1 devices are compatible with the NEST-2 device.
15987588|NCT02981368|Drug|18F-DCFPyL Injection|A single dose of 9±1 mCi (333±37 MBq) IV injection of 18F-DCFPyL
15987589|NCT02981368|Diagnostic Test|PET/CT imaging|PET/CT imaging will be acquired 1-2 hours post-PyL injection
15987590|NCT02981355|Procedure|Microfracture treatment|Microfracture is performed by penetrating the subchondral bone beneath the cartilage lesion inducing a bleeding response.
15987591|NCT02981355|Device|BST-CarGel|BST-CarGel is combined with fresh, autologous whole blood and applied to the lesion on the femoral condyle with a syringe following microfracture arthroscopic surgery.
15987592|NCT02981342|Drug|Abemaciclib|Administered orally
15987593|NCT02981342|Drug|LY3023414|Administered orally
15987594|NCT02981342|Drug|Gemcitabine|Administered IV
15987595|NCT02981342|Drug|Capecitabine|Administered orally
15987596|NCT02981329|Drug|Metformin|Metfomin will be taken daily. The metformin dose will be increased during two time points per subject if protocol dose escalation criteria is met.
15987597|NCT02981329|Behavioral|Questionnaires|Questionnaires will be completed to assess the impact quality of life
15987598|NCT02981316|Biological|RBX7455|Microbiota capsule(s) given twice daily in the morning, and in the evening.
15987599|NCT02981303|Biological|Imprime PGG|Imprime PGG is a soluble, β-1,3/1,6 glucan isolated from the cell wall of a proprietary Saccharomyces cerevisiae yeast strain. Imprime PGG acts as a Pathogen-Associated Molecular Pattern (PAMP). Imprime will be administered at a dose of 4 mg/kg IV over a 2-hour infusion time on Days 1, 8 and 15 of each 3-week treatment cycle.
15987600|NCT02981303|Drug|Pembrolizumab|Pembrolizumab is a humanized monoclonal antibody against the programmed death receptor-1 protein. Pembrolizumab will be given at a fixed dose of 200 mg IV over 30 minutes on Day 1 of each 3-week treatment cycle after the Imprime infusion.
15987601|NCT02981290|Drug|Renodapt|Renodapt will be administered as 500 milligrams (mg) tablet orally on Day 1 in any treatment periods.
15987602|NCT02981290|Drug|Mycept|Mycept will be administered as 500 mg tablet orally on Day 1 in any treatment periods.
15987603|NCT02981290|Drug|Cellmune|Cellmune will be administered as 500 mg tablet orally on Day 1 in any treatment periods.
15987604|NCT02981290|Drug|CellCept|CellCept will be administered as 500 mg tablet orally on Day 1 in any treatment periods.
15987605|NCT02981277|Drug|Transcricoid injection|Lignocaine delivery using Transcricoid Injection
15987606|NCT02981277|Drug|Spray as you go|Lignocaine delivery using Spray as you go method
15987607|NCT02981264|Drug|Transcricoid Injection|
15987608|NCT02981264|Drug|Spray as you go|
15987609|NCT02981251|Behavioral|Health education with support by trained female health volunteer|Along with usual care four sessions of interactive health education will be provided to the participants by medical officer and/or registered nurse based on a syllabus for six months. Trained female female health volunteer will motivate the participants through their home visit twice a month where they will monitor blood pressure and counsel the family members to support the patient.
15987610|NCT02981238|Dietary Supplement|Phytostandard® Eschscholtzia / Valerian|
15987611|NCT02981225|Dietary Supplement|Phytostandard® Rhodiola-Saffron|
15987612|NCT02981212|Drug|Mycophenolate Mofetil|less than 80 kg: 1,500 mg / day , 80 kg or more: 2,000 mg / day divided twice a day and administered orally
15987613|NCT02981212|Drug|ACE inhibitor|maintain conservative treatment (using ACE inhibitor or ARB for blood pressure regulation and proteinuria suppression treatment) just as before randomization
15987614|NCT02981212|Drug|Corticosteroid|combination with Mycophenolate Mofetil
15987615|NCT02981212|Drug|ARB|maintain conservative treatment (using ACE inhibitor or ARB for blood pressure regulation and proteinuria suppression treatment) just as before randomization
15987616|NCT02981199|Procedure|stem cell transplantation|conditioning with chemotherapy [VMD regimen(bortezomib, melphalan, dexamethasone) or Mel+Vel regimen(melphalan, bortezomib)], then stem cell transfusion
15987617|NCT02981186|Device|IOL implantation experimental|Implantation of trifocal IOL POD F GF consisting of hydrophobic material
15987618|NCT02981186|Device|IOL implantation comparator|Implantation of trifocal IOL POD F consisting of hydrophilic material
15987619|NCT02981173|Drug|0.143 mg/kg Psilocybin or 10 mg Psilocybin|0.143 mg/kg psilocybin capsule (weight-based option) or 10 mg psilocybin capsule (fixed-dose option) ingested on each of three test days (5 days apart +/- 1-2 days)
15987620|NCT02981173|Drug|0.0143 mg/kg Psilocybin or 1 mg Psilocybin|0.0143 mg/kg psilocybin capsule (weight-based option) or 1 mg psilocybin (fixed-dose option) ingested on each of three test days (5 days apart +/- 1-2 days)
15987621|NCT02981173|Drug|Placebo|Microcrystalline cellulose capsule ingested on each of three test days (5 days apart +/- 1-2 days)
15987622|NCT02981160|Other|Dietary|The REE testing will be done with the Breezing device, a breath analyzer developed at Arizona State University. The Breezing device is an indirect calorimetry analyzer that measures the rate of oxygen consumption and carbon dioxide production, and determines how much energy the body is burning (REE), and the type of nutrients the body uses to produce energy (energy source). The Breezing device is a cellphone-size, battery-operated, portable technology that syncs with smartphones and electronic pads. The patients will be asked to breathe into a mouthpiece connected to the Breezing device; the data will be then beamed wirelessly to the device. The breath analysis data will displayed on the screen in conjunction with an estimate of total calories burned each day (total energy expenditure, TEE).
15987623|NCT02981147|Drug|Phytus (Cisti, Thyme and Ivy Leaves)|Phytus is a medicinal herb containing Ivy leaves, Cisti and Thyme.
15987624|NCT02981134|Procedure|Computed tomographic scan|after 1year of BVS implantation, computed tomographic scan will be performed
15987625|NCT02981121|Behavioral|Exercise and Diet remedies|
15987626|NCT02981121|Drug|Metformin|
15987627|NCT02981108|Drug|HS-10296|
15987628|NCT02981095|Procedure|Thyroidectomy|Thyroidectomy performed by the same surgical and anesthesia team
15987629|NCT02981095|Drug|Bupivacaine|bupivacaine 0.5%, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.
15987630|NCT02981095|Drug|Saline Solution|%0.9 sodium chloride solution, 10cc was administered to surgical field after completion of Thyroidectomy and approximately 15-30 minutes before the extubation.
15987631|NCT02981082|Drug|Dimethyl Fumarate (DMF)|Dimethyl Fumarate (DMF) is a prescription medicine used to treat relapsing multiple sclerosis.
15987632|NCT02981082|Drug|Placebo Oral Tablet|Sugar pill manufactured to mimic Dimethyl Fumarate (DMF)
15987633|NCT02981069|Drug|Dapagliflozin|10mg
15987636|NCT02981056|Other|Johnson's Baby Top-To-Toe Wash|During the study period, the different intervention products/regimens will be assigned to each group of subjects and replaced their daily wash and or body lotion products. Usage frequency: Ideally 7 times a week, at least 5 times a week, no more than once in the same day.
15987637|NCT02981056|Other|Johnson's Baby Lotion|During the study period, the different intervention products/regimens will be assigned to each group of subjects and replaced their daily wash and or body lotion products. Usage frequency: at least once a day, no more than twice in the same day.
15987638|NCT02981056|Other|Water (in lieu of bathing products)|During the study period, the different intervention products/regimens will be assigned to each group of subjects and replaced their daily wash and or body lotion products. Usage frequency: Ideally 7 times a week, at least 5 times a week, no more than once in the same day.
15987639|NCT02981030|Drug|Mifepristone|Women seeking medical abortion will be offered the option to take mifepristone at home
15987640|NCT02981030|Drug|Misoprostol|Women seeking medical abortion will be offered the option to take misoprostol at home. Misoprostol will be administered buccally.
15987641|NCT02981017|Device|Porcine Intestinal submucosal xenograft|Cook Biodesign ENT repair graft will be used in the experimental group to cover exposed bone in the sinonasal cavity as a result of the Draf III/endoscopic modified lothrop procedure.
15987642|NCT02980991|Drug|Pemetrexed|Two cycles of pemetrexed 500mg/m2 day 1, 21 days per cycle for patients before surgery
15987643|NCT02980991|Drug|Cisplatin|Two cycles of cisplatin 75mg/m2 day 1 (or 25mg/m2 day 1-3), 21 days per cycle for patients before surgery
15987644|NCT02980978|Behavioral|Coaching|Focus on nutrition, activity and appropriate medication use and adherence
15987645|NCT02980965|Drug|letrozole, leuprorelin, fluorouracil, epirubicin, cyclophosphamide, docetaxel|Postmenopausal patients were treated with letrozole 2.5mg/day p.o until complement of neoadjuvant chemotherapy before surgery, while premenopausal ones received letrozole 2.5mg/day p.o and a subcutaneous injection of the GnRH-a, leuprorelin, as concomitant treatment with neoadjuvant chemotherapy (fluorouracil 600mg/m2 IV, epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles followed by docetaxel 100mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles; or epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles, followed by docetaxel 80mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles), letrozole was delivered after 1 week of first dose of leuprorelin injection.
15987646|NCT02980965|Drug|fluorouracil, epirubicin, cyclophosphamide, docetaxel|Patients received fluorouracil 500mg/m2 IV, epirubicin 90mg/m2 IV and cyclophosphamide 500mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles followed by docetaxel 100mg/m2 IV on day 1 at 3-weekly intervals for 3 cycles; or epirubicin 90mg/m2 IV and cyclophosphamide 600mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles, followed by docetaxel 100mg/m2 IV on day 1 at 2-weekly intervals for 4 cycles.
15987647|NCT02980952|Other|High-fat overfeeding|
15987648|NCT02980952|Other|Forearm immobilization|
15987649|NCT02980939|Other|iv fluid infusion|Intravenous isotonic saline infusion
15987650|NCT02980926|Drug|Mepivacaine|This is a shorter acting spinal anesthetic as compared to the current standard of care at this institution.
15987651|NCT02980926|Drug|Bupivacaine|This is the current standard of care at this institution and many centers. This is a longer acting spinal anesthetic compared to the study drug.
15987652|NCT02980913|Device|Thealoz Duo eye drops and Thealoz Duo gel|Thealoz Duo eye drops during the day + Thealoz Duo gel at night (1 drop before going to bed) for 7 days
15987653|NCT02980913|Device|Thealoz Duo gel|Thealoz Duo gel during the day and at night for 7 days
15987654|NCT02980900|Dietary Supplement|Post exercise protein-polyphenol supplement|Participants will ingest a post exercise protein-polyphenol supplement. This will begin 6 days before eccentric exercise and will end 6 days after eccentric exercise.
15987655|NCT02980900|Dietary Supplement|Post exercise placebo supplement|Participants will ingest an isocaloric placebo supplement after exercise. This will begin 6 days before eccentric exercise and will end 6 days after eccentric exercise.
15987656|NCT02980900|Dietary Supplement|Pre bed protein-polyphenol supplement|Participants will ingest a protein-polyphenol supplement before bed. This will begin 6 days before eccentric exercise and will end 6 days after eccentric exercise.
15987657|NCT02980900|Dietary Supplement|Pre bed placebo supplement|Participants will ingest an isocaloric placebo supplement before bed. This will begin 6 days before eccentric exercise and will end 6 days after eccentric exercise.
15987659|NCT02980874|Drug|suprachoroidal CLS-TA|suprachoroidal injection of CLS-TA
15987660|NCT02980874|Drug|suprachoroidal sham|suprachoroidal sham procedure
15987661|NCT02980874|Drug|IVT aflibercept|2 mg intravitreal injection of aflibercept
15987662|NCT02980861|Procedure|Laparoscopic total gastrectomy|When the participants with advanced proximal gastric cancer are randomized in the laparoscopic totalgastrectomy (LATG) group, they will received LTG with spleen-preserving splenic hilum lymph nodes dissection.
15987663|NCT02980861|Procedure|Open total gastrectomy|When the participants with advanced proximal gastric cancer are randomized in the open total gastrectomy(OTG) group, they will received OTG with spleen-preserving splenic hilum lymph nodes dissection.
15987664|NCT02980848|Other|Screening digital mammography|Screening with digital mammography alone
15987665|NCT02980848|Other|Screening digital breast tomosynthesis|Screening with digital mammography plus digital breast tomosynthesis
15987666|NCT02980848|Other|Screening breast magnetic resonance imaging|Screening with digital mammography plus breast magnetic resonance imaging
15987667|NCT02980848|Other|Diagnostic mammography|Pre-operative diagnostic work-up with mammography alone
15987668|NCT02980848|Other|Pre-operative breast magnetic resonance imaging|Pre-operative diagnostic work-up with mammography plus breast magnetic resonance imaging
15987669|NCT02980835|Drug|Normal Saline|Blocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectate B contains 10 mL of 0.9% normal saline.
15987838|NCT02979535|Biological|Human Papillomavirus Bivalent [Types 16 and 18] Vaccine, Recombinant|0.5 mL, IM at Day 0 and Month 6
15987670|NCT02980835|Drug|Ropivacaine|Blocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectate A and C contain 9 and 24 mL of ropivacaine HCl 0.5%, respectively.
15987671|NCT02980835|Drug|Epinephrine|Blocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectate C contains 0.125 mL of epinephrine-1:1000 preparation.
15987672|NCT02980835|Drug|Dexamethasone|Blocking the nerves between the ribs with a local anesthetic is normally done as a part of routine care at the end of the surgery in one set of injections. Intervention group will receive injectate A at the beginning and injectate B and C prior to the closure. Control group receive injectate B at the beginning of surgery and injectate A and C prior to the closure and end of surgery. Injectates A and C both contain 1 mL of dexamethasone 4mg/mL preparation.
15987673|NCT02980809|Drug|Apatinib|
15987674|NCT02980809|Drug|Topotecan|
15987675|NCT02980796|Behavioral|Exercise|Each experimental day participants will complete an acute bout of exercise on a recumbent bike.
15987676|NCT02980796|Behavioral|Practice|Each experimental day participants will complete a session of skilled motor practice.
15987677|NCT02980783|Device|Juvéderm® VOLIFT®™ with Lidocaine|Juvéderm® VOLIFT®™ (hyaluronic acid) with Lidocaine is injected into the dynamic radial cheek line skin depressions on Day 1; volume of injection will not exceed 2 mL per side. If applicable, a touch-up of Juvéderm® VOLIFT®™ with Lidocaine will be injected on Day 14; volume will not exceed 1 mL per side.
15987678|NCT02980757|Drug|Gliclazide 120 mg MR Tablets Formula A|
15987679|NCT02980757|Drug|Gliclazide 120 mg MR Tablets|
15987680|NCT02980757|Drug|Gliclazide 120 mg MR Tablets Formula B|
15987681|NCT02980744|Behavioral|Sedentary behaviour intervention|The intervention is based on socio-cognitive theory and focuses on building and increasing confidence (self-efficacy) to make a behaviour change. Output from the activity monitor (i.e. activPAL) will provide visual feedback of usual activity. Action plans targeting areas of high sedentary behaviour will be developed. A wrist-worn Misfit activity monitor is used as a self-monitoring tool throughout the intervention. This commercially available device provides activity information in real time, and sets daily targets for physical activity. A checklist will be used to address: 1) use of walking aids; 2) incidence of falls; 3) review and progression of home exercise program; and 4) quality of walking. The intervention visits will be conducted by a physical therapist.
15987682|NCT02980731|Drug|Venetoclax|Tablet
15987683|NCT02980718|Behavioral|intensive olfactory training|
15987684|NCT02980718|Behavioral|ordinary olfactory training|
15987685|NCT02980705|Drug|SUNPG1622 I dose|Injection
15987686|NCT02980705|Drug|Placebo dose|Injection
15987687|NCT02980692|Drug|SUNPG1623 I|injection
15987688|NCT02980692|Drug|SUNPG1623 II|injection
15987689|NCT02980692|Drug|SUNPG1623 III|injection
15987690|NCT02980692|Drug|SUNPG1623 IV|injection
15987691|NCT02980692|Drug|PLACEBO|injection
15987692|NCT02980679|Drug|CTC|After injection of CTC, a whole body and thyroid scan will be performed.
15987693|NCT02980679|Drug|G-PERT|After injection of G-PERT, a whole body and thyroid scan will be performed.
15987694|NCT02980666|Drug|Teduglutide|0.05 mg/kg/day SC injection once daily for 24 weeks.
15987695|NCT02980653|Drug|Megestrol acetate (MA) 400 mg/day|Megestrol acetate (MA) will be given on 400 mg/day as eligible patient begin CCRT. Total treatment period is for a maximum of 12 weeks calculated from the date of first dose.
15987696|NCT02980627|Behavioral|Therapy with Mobile App Enhancement|"Treatment includes 12 weekly therapy sessions with daily RR app use between sessions. Intervention is CBT-based and specifically draws from ACT. ACT is a contextual behavior therapy that emphasizes the function of behavior (e.g., affect regulation) and helps individuals accept (or tolerate) emotional discomfort for a broader purpose (i.e., personal values). Broadly, treatment will focus on improving diabetes management by increasing patients' capacity to effectively cope with psychological barriers to self-care using acceptance and mindfulness strategies."
15987697|NCT02980614|Device|4D flow imaging|To compare the quantification of pulmonary valve leakage by standard 2D flow MRI and 4D flow MRI by measuring the regurgitation fraction (ratio of retrograde blood flow to anterograde flow) in the pulmonary artery
15987698|NCT02980601|Device|Integra plus STSG|A sheet of Integra directly on the wound bed with subsequent removal of the overlying silicone sheet and immediate application of a 0.008mm STSG
15987699|NCT02980601|Procedure|STSG|0.012mm STSG
15987700|NCT02980588|Device|SGC directed glycemic control|the patients' blood glucose is controlled by SGC system through insulin continuous infusion whose dosage is determinated by SGC
15987701|NCT02980575|Other|Music|
15987702|NCT02980575|Other|Exercise|
15987703|NCT02980562|Drug|Polyethylene Glycols|(Split dose 2L PEG-Asc)
15987704|NCT02980562|Drug|Bisacodyl|(1L PEG-Asc plus bisacodyl)
15987705|NCT02980549|Other|children's sleep habits questionnaire|survey of children's sleep habits completed by parent
15987706|NCT02980523|Drug|PRO-157|PRO-157 (Pazufloxacin 0.06%) Laboratories Sophia S.A. de C.V., ophthalmic solution
15987707|NCT02980523|Drug|Vigamox|Vigamox® (Moxifloxacin 0.5%), Alcon Laboratories, S.A. de C.V., ophthalmic solution
15987708|NCT02980523|Drug|Zymar®|Zymar® (Gatifloxacin 0.3%), Allergan, S.A. de C.V., ophthalmic solution
15987709|NCT02980523|Drug|Lagricel Ofteno®|Lagricel Ofteno® Sodium hyaluronate 0.4%, Laboratories Sophia S.A. de C.V., ophthalmic solution
15987710|NCT02980510|Drug|Panitumumab, oxaliplatin, folinic acid, 5-fluoruracil|
15987711|NCT02980510|Drug|Panitumumab, oxaliplatin, folinic acid, 5-fluoruracil, irinotecan|
15987712|NCT02980497|Other|Listerine Zero Mouthwash (without alcohol)|20 ml of rinse for 30 seconds, twice a day
15987713|NCT02980497|Other|Listerine Antiseptic Mouthwash (with alcohol)|20 ml of rinse for 30 seconds, twice a day
15987839|NCT02979535|Biological|Human Papillomavirus Bivalent [Types 16 and 18] Vaccine, Recombinant|0.5 mL, IM at Day 0 and Month 6
15987714|NCT02980484|Procedure|Active|Repetitive transcranial magnetic stimulation (rTMS) will be applied to the left dorsolateral prefrontal cortex (DLPFC) (4000 pulses, 10 Hz, 5-sec trains, 25-sec inter-train interval) followed by the right DLPFC (1000 pulses, 1 Hz frequency, single train). The DLPFC will be identified using individual subject-level resting-state network estimation (Hacker et al, 2013). Each treatment will be completed over the course of 1 hour, and each subject will receive a total of 20 treatments over the course of 20 consecutive weekdays.
15987715|NCT02980484|Procedure|Sham|Treatment that looks and feels similar to active rTMS will be administered as a sham treatment.
15987716|NCT02980471|Device|Pulse Oximeter|Blood removal and reintroduction as measured by the plethysmograph of a pulse oximeter
15987717|NCT02980458|Drug|Deferiprone 500Mg Tablet|
15987718|NCT02980458|Drug|Deferiprone 500 MG Oral Tablet [Ferriprox]|
15987719|NCT02980445|Behavioral|Outdoor activity 1|40-minute outdoor activity
15987720|NCT02980445|Behavioral|Outdoor activity 2|Dose 1 plus an additional 40-minute outdoor activities during recesses
15987721|NCT02980432|Other|changes in whole-body roll position and visual/haptic stimuli presented|In different whole-body roll positions subjects will be presented a luminous line or a rod in combination with a moving or stationary background. Participants will be asked to align the line or the rod along perceived direction of gravity.
15987722|NCT02980419|Behavioral|presentation of visual and vestibular stimuli|In each participant the investigators will assess verticality perception in whole-body upright position by use of the SVV, the SPV and the SHV after static roll-tilt at ±90deg over 5min. Measurements will be obtained on a motor-driven turntable and two different roll-tilt positions will be applied (±90°). A visual line (SVV), a rod (SHV) or the turntable itself will be adjusted to indicate perceived direction of vertical. A total of three measuring sessions, each lasting about 60 minutes are scheduled.
15987723|NCT02980406|Dietary Supplement|FODMAP|Fermentable oligo-, di- and monosaccharides and polyols are poorly absorbed carbohydrates that are known to cause symptoms in IBS patients.
15987724|NCT02980406|Dietary Supplement|Glucose (control)|Glucose is not a FODMAP.
15987725|NCT02980393|Behavioral|Lifestyle intervention|The structured lifestyle intervention involves alternating weekly phone calls with two health coaches: a registered dietitian and a fitness specialist. A total of 50 phone calls (25 nutrition-related and 25 physical activity-related) are delivered over the one-year study. After six months in the program, participants are introduced to supporting program-specific software that they can access online, as an additional way to interact with the program, set goals, and record their progress. Client and family-centred nutrition and physical activity counselling includes an initial and regular behavioural assessment, and subsequent conversations (i.e., phone calls) using motivational interviewing techniques intended to increase knowledge or skills, and improve behaviours.
15987726|NCT02980380|Other|Non-invasive brain computer interface|"The hemodynamic change in the motor cortex of the CLIS patient will be recorded across many sessions spread over more than a year and will be used to train a classifier to predict the yes and no answering pattern of the CLIS patient. For patient who can still open their eyes but cannot use any other means of communication will control an EEG based BCI for communication."
15987727|NCT02980367|Other|Non-Surgical Management (Rehabilitation)|Routine ACL rehabilitation protocols used at the participating site will be followed. As part of the site selection process, documentary evidence of the use of or willingness to adopt a rehabilitation protocol that reflects the guidelines of the mandatory aims/goals set for the study rehabilitation intervention will be required.
15987728|NCT02980367|Procedure|Surgical Management (Reconstruction)|All surgical reconstructions will be patella tendon or hamstrings tendon depending on the surgeon's preference. All other care will be routine, including immediate post-operative care.
15987730|NCT02980328|Device|Low-level light therapy|we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating overactive bladder. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule.
15987731|NCT02980328|Device|Placebo|we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating overactive bladder. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule.
15987732|NCT02980315|Other|CAR-T cells|the patients treat with CAR-T cells
15987733|NCT02980302|Procedure|Cutaneous biopsy|Under local anesthesia
15987734|NCT02980276|Drug|Metformin Hydrochloride|Women randomised to the metformin group will receive metformin 500mg once daily, with the dose titrated upwards every 2 days over 10 days increasing to a maximum of 2500mg Metformin daily (5 tablets) or maximum tolerated dose, in addition to usual care (exercise and MNT), and taken until delivery.
15987735|NCT02980276|Other|Placebo|Women randomised to the placebo group will receive 1 placebo tablet once daily, with the dose titrated upwards every 2 days over 10 days increasing to a maximum of five placebo tablets daily, in addition to usual care (exercise and MNT), and taken until delivery.
15987736|NCT02980263|Drug|Canakinumab|
15987737|NCT02980250|Drug|Low dose|0.2mg group-The premature infant will be fed with 0.2mg/kg/tds domperidone and will be tested the residual glucose everyday in a 7-days period.
15987738|NCT02980250|Drug|normal dose|0.4mg group-The premature infant will be fed with 0.4mg/kg/tds domperidone and will be tested the residual glucose everyday in a 7-days period.
15987739|NCT02980250|Drug|over dose|0.6mg group-The premature infant will be fed with 0.6mg/kg/tds domperidone and will be tested the residual glucose everyday in a 7-days period.
15987740|NCT02980250|Drug|Glucose|Glucose group-The premature infant will be fed with glucose and will be tested the residual glucose everyday in a 7-days period.
15987765|NCT02980094|Dietary Supplement|Milk Antioxidant group(A)|There is no intervention pre-specified before the institutionalized elderly to receive three times per day of milk (total 600ml of milk all day) produced by lactating cows fed with the following diets: control (C)+selenium and vitamin E (A).
15987741|NCT02980237|Other|eHealth_additional support|An e-learning education program whose audiovisual content will be implemented. Nine audiovisual e-Health program will be composed of nine video classes addressing the following topics: 1) musculoskeletal health, 2) healthy diet and 3) mental health were identified through focus group. A communication tool will be adopted is the Moodle environment. All the participants will be able to whipping the web platform and questions regarding access and navigation are answered by e-mail. All participants will be monitored, as viewing the videos, and whenever it is identified that the participants not accessed and lack of interest of reasons. A team of tutors will be responsible for online support providing reinforcing stimuli and clarifying any questions (intervention group) on the content.
15987742|NCT02980237|Other|eHealth_program|The comparative group will receive the same eHealth education program that intervention group. But the comparative group will receive only audiovisuals without additional support. .
15987743|NCT02980224|Drug|OmegaD|OmegaD Softgels
15987744|NCT02980224|Drug|Placebo|Placebo Softgels
15987745|NCT02980211|Drug|Alveolar Ridge Reconstruction|Reconstruction of dehiscence defects in extraction sockets with a minimally invasive technique using a particulate bone allograft and a non-absorbable dense polytetrafluoroethylene (dPTFE) membrane
15987746|NCT02980198|Biological|IFN-Kinoid|IM administration
15987747|NCT02980198|Other|Placebo|IM administration
15987748|NCT02980198|Other|ISA 51|adjuvant
15987749|NCT02980185|Procedure|Laparoscopic primary cytoreduction|Primary cytoreduction for ovarian cancer performed through a completely minimally-invasive approach
15987750|NCT02980172|Other|Pain evaluation|Evaluation of pain using a numerical scale (1 to 10)
15987751|NCT02980159|Other|Triage liaison physician|A triage liaison physician is present from 7:30 am to 10:30 pm, Monday to Friday, with the mission to evaluate quickly patients who cannot be immediately installed in an ED room
15987752|NCT02980146|Other|Non interventional study|
15987753|NCT02980133|Drug|Fluticasone Propionate|Fluticasone propionate was administered via MDPI per the dose and schedule specified in the arm.
15987754|NCT02980133|Drug|Fluticasone Propionate/Salmeterol|Fluticasone propionate/salmeterol was administered via MDPI per the dose and schedule specified in the arm.
15987755|NCT02980133|Drug|Placebo MDPI|Matching placebo was administered via MDPI per the schedule specified in the arm.
15987756|NCT02980120|Other|SCID-I|The structured clinical interview for DSM-IV Axis I Disorder (SCID-I, German translation, see Wittchen, Zaudig & Fydrich, 1997) is a semi-structured interview to diagnose AN and BM. It allows a detailed assessment of ED symptoms across different settings and time periods necessary to make an accurate diagnosis.
15987757|NCT02980120|Other|EAT|The Eating Attitudes Test (EAT) is a standardized questionnaire of symptoms and concerns related to ED (Garner & Garfield, 1979, German translation by Steinhausen). The questionnaire consists of 40 items on a six-point Likert scale, providing information
15987758|NCT02980120|Other|EDI-2|The Eating Disorder Inventory 2 (Paul & Thiel, 2004) is a self-report questionnaire on psychological features generally associated with AN and BN.The instrument consists of 91 items on a six-point Likert scale. The 11 scales are drive for thinness, bulimia, body dissatisfaction, ineffectiveness, perfectionism, interpersonal distrust, interoceptive awareness, maturity fears, asceticism (provisional), impulse regulation (provisional) and social insecurity (provisional). It was designed as a diagnostic aid; its psychometrics have been tested, with studies demonstrating satisfactory internal consistency reliability coefficients (between .44 and .93), test-retest reliability of .79 to .95 (after one week) and above .80 (after three weeks), and content, convergent and discriminant validity.
15987759|NCT02980120|Other|SCID-II|The SCID-II interview (German, see Wittchen, Zaudig & Fydrich, 1997) is a widely used and researched instrument to assess DSM-IV-TR personality disorders.The interview covers all ten DSM-IV personality disorders (antisocial, avoidant, borderline, dependent, histrionic, narcissistic, obsessive-compulsive, paranoid, schizoid and schizotypal), PD not otherwise specified, and appendix categories (depressive PD and passive-aggressive PD) and is used to make personality disorder diagnoses either dimensionally or categorically (present-absent). Furthermore, it allows the investigation of patterns of PD that co-occur with other mental disorders as well as the analysis of the underlying structure of personality pathology.
15987760|NCT02980120|Other|LoPF|In order to specifically focus on certain personality traits, we use the LoPF as an additional measure. It is a well-validated and reliable self-report questionnaire to measure healthy and pathological personality functioning in adolescents. It is based on the DSM-5 Section III Alternative Model for Personality disorders and covers core impairments in adolescents' personality functioning: identity, self-direction (self-related personality functioning), intimacy/ attachment and empathy/ social-related personality functioning (Sevecke & Krischer, 2011).
15987761|NCT02980120|Other|HAWIK-IV|The Wechsler Intelligence Scale for Children (HAWIK-IV, Petermann & Petermann, 2008) will be used assess intelligence. For adolescents older than 16.11 years, we will use the German version of the Wechsler Adult Intelligence Scale (HAWIE-IV).Results from test-retest reliability demonstrate that the mean retest scores for all subtests are higher than the mean test scores from first administration, with effect sizes ranging from .08 (comprehension) to .60 (picture completion). The test has demonstrated an acceptable relationship to other measures of achievement, memory, adaptive behavior, emotional intelligence and giftedness in children and adolescents (Canivez, 2014). For the non-clinical adolescent sample, we will use two subtests of the HAWIK.
15987762|NCT02980120|Device|fMRI|To measure food-related brain activation, event-related fMRI will be used, with phases of high-caloric images alternating with phases of low-caloric images and images of fixation cross (not related to food images). A total of 18 blocks will be performed - see figure below. The duration of each phase will be 30 seconds. In a second run, the patients and control subjects will drink chocolate milk and water, alternating every 30 seconds, through a long silicon tube. This procedure was successfully tested in a previous fMRI study with adult AN patients (Gizewski et al. 2010, Vocks et al. 2011) and has now been adopted in preliminary measurements for young AN patients.
15987763|NCT02980107|Other|Infographics|Cochrane started developing infographics, where short textual information about research is supported by visual representations of the main findings and is also aimed at the lay public The investigators will examine whether this format is better in information uptake than standard PLS.
15987764|NCT02980107|Other|PLS|Text format with simple explanation of the survey topic main findings and is intended for lay audience.
15987766|NCT02980094|Dietary Supplement|Milk Oil group(O)|There is no intervention pre-specified before the institutionalized elderly to receive three times per day of milk (total 600ml of milk all day) produced by lactating cows fed with the following diets: control (C)+sunflower oil (O).
15987767|NCT02980094|Dietary Supplement|Milk Antioxidant and oil(AO)|There is no intervention pre-specified before the institutionalized elderly to receive three times per day of milk (total 600ml of milk all day) produced by lactating cows fed with the following diets:control (C)+selenium, vitamin E and sunflower oil (AO).
15987768|NCT02980094|Dietary Supplement|Milk Control group(C)|There is no intervention pre-specified before the institutionalized elderly to receive three times per day of milk (total 600ml of milk all day) produced by lactating cows fed with the following diets: control (C)
15987769|NCT02980081|Other|abdominal plain x-ray|Abdominal plain x-ray as prescribed by the emergency physician
15987770|NCT02980068|Drug|15N Nitrate|1,000 mg/11.8 mmol, oral, on day one, hour zero
15987771|NCT02980068|Drug|14N Nitrate|1,000 mg/11.18 mmol, oral, on day hour, hour zero
15987772|NCT02980055|Procedure|collagen matrix|Surgical procedure for root coverage using collagen matrix
15987773|NCT02980055|Procedure|connective tissue graft|Surgical procedure for root coverage using connective tissue graft
15987774|NCT02980042|Drug|Ocrelizumab|A humanized monoclonal antibody that targets CD20 and selectively depleted CD-20 expressing B cells
15987775|NCT02980042|Drug|Rituximab|A chimeric monoclonal antibody against CD20.
15987776|NCT02980029|Drug|TVB-2640|TVB-2640 is a potent and reversible inhibitor of the FASN enzyme. TVB-2640 inhibits the β-ketoacyl reductase (KR) enzymatic activity of the FASN enzyme. TVB-2640 is uncompetitive towards both NADPH and acetoacetyl-CoA in inhibiting KR activity.
15987777|NCT02980029|Other|Placebo|Placebo
15987778|NCT02980016|Drug|rifapentine + isoniazid|Rifapentine + isoniazid Once weekly rifapentine (at a dose of 900 mg) plus isoniazid (at a dose of 900 mg), with adjustment for participants weighing ≤50 kg
15987779|NCT02980016|Drug|Isoniazid|Daily self-administered isoniazid (at a dose of 300 mg/daily), with adjustment for participants weighing ≤24 kg
15987780|NCT02980003|Drug|isotonic saline|patients will start hydration with isotonic saline 6 hours before angiography and continue for 12 hours after the procedure.
15987781|NCT02980003|Drug|i.v. sodium bicarbonate|patients will start hydration with isotonic saline 6 hours before angiography and continue for 12 hours after the procedure. The patient receives solution of 1.4% sodium bicarbonate (167 mEq/L; 334 mOsm/L) one hours and six hours after procedure.
15987782|NCT02980003|Drug|oral sodium bicarbonate|patients will start hydration with isotonic saline 6 hours before angiography and continue for 12 hours after the procedure. One hour before the angiography and 3 hours after patients will receive oral sodium bicarbonate at the dose of 4 g (47.6 mEq) dissolved in 60 mL of water
15987783|NCT02979990|Other|Instructional Video|The experimental group will be asked to view a set of videos that demonstrate proper usage of controlled ovarian stimulation medication. They will have the opportunity to review instructional videos as needed throughout the ovarian stimulation process.
15987784|NCT02979990|Other|Control Video|The control group will have access to a video about the IVF process
15987785|NCT02979977|Drug|cetuximab|30-60 minutes after the recommended pre-medications, cetuximab will be administered intravenously at a dose of 400mg/m2 on cycle 1, day 1 of treatment (loading dose) and at a dose of 250mg/m2 every 7 days (+/- 1 day) thereafter. Alternatively, patients can be treated at a dose of 500mg/m2 every 14 days (+/- 2 days).
15987786|NCT02979977|Drug|afatinib|Patients will take a single oral dose of afatinib each day at a dose of 30 mg. Afatinib dose will not be escalated beyond the 30 mg daily oral dose; dose reductions of afatinib can occur to manage treatment related adverse events.
15987787|NCT02979964|Behavioral|Audit and Feedback|
15987788|NCT02979938|Other|Semen analysis and semen PCR for Zika virus|Every two weeks subjects provide a semen sample which is analysed and then frozen for RT-PCR and viral load. Semen sample testing for the presence of ZIKV (Institute of Tropical Medicine, Belgium) will be performed using both a ZIKV-specific, in-house duplex real-time RT-PCR, targeting a 102bp and 121bp sequence of the NS5 gene and the RealStar® Zika Virus RT-PCR Kit (Altona). Quantitative viral load RNA measurements will be expressed utilizing threshold cycle values because a standardized viral load reference method is not available. To test for infectivity of ZIKV in semen, ZIKV isolation will be attempted in semen samples with a high viral ZIKV load (i.e. positive ZIKV PCR result and Ct-values below 30) by inoculation in Vero cells.
15987789|NCT02979925|Device|Active Transcutaneous Magnetic Stimulation|Active transcutaneous magnetic stimulation (TMS) at the target site of nerve damage/injury.
15987790|NCT02979925|Device|Sham Transcutaneous Magnetic Stimulation|Sham TMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
15987791|NCT02979912|Biological|Platelet Lysate|Eye drops of Platelet Lysate
15987792|NCT02979899|Biological|TRC105|TRC105 antibody
15987793|NCT02979899|Drug|Votrient|pazopanib
15987794|NCT02979886|Drug|GnRH-a|the hormone reaction to the down regulation of the patients
15987795|NCT02979886|Drug|Human Menopausal Gonadotropins|the effects on the serum LH level of day of HCG
15987835|NCT02979548|Drug|Metoclopramide|Dopamine receptor antagonist , acts at CTZ. Rescue medication, injection metoclopramide 0.5 mg/kg body weight/day.
15987836|NCT02979535|Biological|CYD Dengue Vaccine|0.5 mL, SC at Day 0, Months 6 and 12
15987837|NCT02979535|Biological|CYD Dengue Vaccine|0.5 mL, SC at Months 1, 7, and 13
15987800|NCT02979847|Procedure|hybrid approach|Before transseptal puncture, epicardial puncture is performed through subxyphoid approach. Atrial epicardial potentials are recorded using multi-electrode catheter, leading an activation map for atrial tachycardia and map for continuous fractionated atrial electrograms during atrial fibrillation. Endocardial potentials are also recorded in the same fashion. Procedural endpoint is a tachycardia termination or a noninducibility of tachycardia.
15987801|NCT02979847|Procedure|conventional endocardial approach|Atrial endocardial potentials are recorded using multi-electrode catheter, leading an activation map for atrial tachycardia and map for continuous fractionated atrial electrograms during atrial fibrillation. Procedural endpoint is a tachycardia termination or a noninducibility of tachycardia.
15987802|NCT02979821|Drug|Poziotinib|A cycle of study treatment is defined as 28 days.
15987803|NCT02979808|Device|Navina Smart|Subjects treatment-naïve to transanal irrigation (TAI). Frequency of TAI will be tailored to each subject.
15987804|NCT02979795|Procedure|Preoperative chemoradiotherapy|Preoperative chemoradiotherapy. 2.5 Gray/fraction (Total in 45-54 Gray)
15987805|NCT02979782|Procedure|Endo-CABG|minimal invasive cardiac intervention
15987806|NCT02979782|Procedure|PCI|stenting procedure
15987807|NCT02979769|Drug|Palovarotene|Palovarotene will be taken orally once daily at approximately the same time each day.
15987808|NCT02979756|Procedure|Decentralized GDM screening and initial management|Screening for GDM and initialization of nutritional therapy at the first level of care
15987809|NCT02979743|Behavioral|Occupational therapy|
15987810|NCT02979743|Other|Occupational therapy puls acupuncture and massage methods|
15987811|NCT02979730|Other|Core Lab Test|For patients randomized to the Core Lab Testing Arm, ED physicians will order an influenza test to be performed in the core lab.
15987812|NCT02979730|Other|ED Point of Care Test|For patients randomized to the ED Point of Care Testing Arm, the Research Assistant will perform influenza testing in the Emergency Department, using the Cobas Liat Influenza A/B assay
15987813|NCT02979717|Dietary Supplement|High protein, high fiber dietary supplement|
15987814|NCT02979717|Other|Low protein, low fiber comparator|
15987815|NCT02979704|Drug|Rosuvastatin|45 patients will be treated with rosuvastatin at a dose of (5-10) mg orally once daily dose for 08 weeks
15987816|NCT02979704|Drug|Atorvastatin|45 patients will be treated with atorvastatin at a dose of (10-20) mg orally once daily dose for 08 weeks
15987817|NCT02979691|Radiation|SIB-IMRT|
15987818|NCT02979691|Drug|S-1|
15987819|NCT02979678|Other|Questionnaire|The questionnaire should be updated with respect to wording, terminology.
15987820|NCT02979665|Drug|Ranibizumab Ophthalmic|"Ranibizumab (trade name Lucentis among others) is a monoclonal antibody fragment (Fab) created from the same parent mouse antibody as bevacizumab. It is an anti-angiogenic that has been approved to treat the wet type of age-related macular degeneration (AMD, also ARMD), a common form of age-related vision loss and diabetic macular edema (DME)."
15987821|NCT02979639|Biological|GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A)|2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm on a 2 month schedule.
15987822|NCT02979626|Procedure|Respiratory nasal swab|Nasal swabs will be obtained for testing by the study nurses. If a respiratory sample has already been collected as part of routine clinical care, this will replace the study collection, and no additional testing will be required.
15987823|NCT02979613|Drug|TAF|25 mg tablet administered orally once daily
15987824|NCT02979613|Drug|TDF|300 mg tablet administered orally once daily
15987825|NCT02979613|Drug|TAF Placebo|Tablet administered orally once daily
15987826|NCT02979613|Drug|TDF Placebo|Tablet administered orally once daily
15987827|NCT02979587|Device|Harmony TPV System|"The Harmony™ TPV (Model NTPV0022) is comprised of a 22mm porcine pericardium valve, sewn to a polyester-covered nitinol frame.
~The Harmony TPV 25 and mTPV 25 (Model HTPV254952 and HTPV254252, respectively) is comprised of a 25mm porcine pericardium valve, sewn to a polyester covered asymmetrical hourglass nitinol frame with larger diameter inflow and outflow as well as shorter length compared to TPV 22 (Harmony TPV 25 Model HTPV254952 is not applicable for Continued Clinical Experience).
~The Harmony Delivery System (DS) for the TPV 22, TPV 25, and mTPV 25 (NTPVDS0022 and HTPVDS0025) are all 25 Fr delivery systems using a coil loading catheter."
15987828|NCT02979574|Procedure|Electro-Acupuncture (EA)|Participants will receive 10 treatment of Electro-Acupuncture over the course of 10 weeks (with a maximum of 2 treatments per week). The acupuncturist will insert acupuncture needles in at least 4 local points around the body with the most pain and at least 4 distant points to address the patient's baseline constitution. The needles will be electrically stimulate at 2 Hz by connecting to a TENS unit. The needles will be in place for 30 minutes.
15987829|NCT02979574|Procedure|Battle Field Acupuncture (BFA)|Participants will receive 10 treatment of Battle Field Acupuncture over the course of 10 weeks (with a maximum of 2 treatments per week). Acupuncture needles will be placed in the participants' ears. The total duration of BFA delivery is about 10 to 20 minutes depending on how many needles are used in the procedure.
15987830|NCT02979574|Device|Wait List Control (WLC)|After the waiting period (12 weeks from randomization), participants in the WLC will receive up to ten treatments of either EA or BFA based on their personal preference.
15987831|NCT02979561|Drug|Dabigatran Etexilate|All patients in this group continue to receive unfractionated heparin for 5-7 days, and then transferred to the drug Pradaxa dose of 150 mg 2 times a day. Pradaxa administration continued until the end of the treatment period. The treatment period starts on the day of randomization and lasts for 6 months.
15987832|NCT02979561|Drug|Warfarin|all patients continue to receive unfractionated heparin intravenously and at the same time (from the date of randomization) start warfarin, accompanied by regular measurement of the INR every day or every other day. As soon as INR reaches the range of 2.0 to 3.0, the administration of the unfractionated heparin should be discontinued. Further measurements of INR should be performed once a month during outpatient visits. The patient continues to receive warfarin under the control of the INR till the end of the treatment period. The treatment period starts on the day of randomization and lasts for 6 months.
15987833|NCT02979548|Drug|Aprepitant|Aprepitant is a non peptide, selective, Neurokinin type 1 (NK 1) receptor antagonist. Group A will receive Aprepitant as an add-on anti-emetic therapy in addition to ondansetron.
15987834|NCT02979548|Drug|Ondansetron|Ondansetron is 5HT3 Receptor antagonist used to treat and prevent chemotherapy induced nausea and vomiting
15987844|NCT02979509|Other|Endoscopic ultrasound- (EUS) guided tissue sampling|EUS- guided tissue sampling of solid and/or cystic pancreatic and non-pancreatic lesions as part of their medical care.
15987845|NCT02979496|Dietary Supplement|0 g pomace (control)|16 oz of juice containing 0 g of citrus pomace will be consumed each day for 3 weeks by participants in the group receiving this assignment (group is unknown, double-blinded)
15987846|NCT02979496|Dietary Supplement|90 g pomace|16 oz of juice containing 90 g of citrus pomace will be consumed each day for 3 weeks by participants in the group receiving this assignment (group is unknown, double-blinded).
15987847|NCT02979496|Dietary Supplement|180 g pomace|16 oz of juice containing 180 g of citrus pomace will be consumed each day for 3 weeks by participants in the group receiving this assignment (group is unknown, double-blinded).
15987848|NCT02979496|Dietary Supplement|Flavored water (control)|16 oz of a flavored, calorie-matched water beverage will be consumed each day for 3 weeks by participants in the group receiving this assignment (group is unknown, double-blinded).
15987849|NCT02979483|Procedure|Integrative supportive care|"At the inclusion, the investigator determine a personalized program of supportive care procedures for each patient (for instance : treatment of pain and nutritional support,stenting of bile duct and/or duodenum, tumor biopsy for pathologic diagnosis ,..)
~At the end on the integrative supportive care, according to the ECOG-PS of patients , they will be classified into two groups:
~Group 1 :Good prognosis - ECOG-PS 0-1 and eligible for clinical trial, FOLFIRINOX or gemcitabine + nab-paclitaxel.
~Patient will be treated by : FOLFIRINOX or gemcitabine-nab-paclitaxel or clinical trial
~- Group 2 : Poor prognosis - ECOG-PS 2-4 and / or ineligible for clinical trial, FOLFIRINOX or gemcitabine + nab-paclitaxel.
~Patients will be treated by: FOLFOX7lightened"
15987850|NCT02979457|Behavioral|Awareness of degree of worry|degree of worry is a definition made for this project. It is roothed in coping psychology but has been influenced by the construct of self-rated health. Will blinding of DOW have an effect on triage outcome.
15987851|NCT02979444|Behavioral|Mothers and Babies Groups|"The Mothers and Babies group intervention is comprised of 6, two hour sessions. It is divided into three overall sections, one on each of the following Cognitive Behavioral Theory components; Pleasant Activities, Thoughts, and Contact with Others. In each of these sections, participants are first taught to understand how the component influences her mood. This teaching of the relationships between CBT components and mood is referred to as psychoeducation. In addition to psychoeducation, participants also receive concrete skills in each of the three sections (pleasant activities, thoughts, contact with others). These skills are intended to provide participants with a toolkit of approaches they can use to improve their mood."
15987852|NCT02979431|Biological|ALX-0171 3.0 mg/kg|
15987853|NCT02979431|Biological|ALX-0171 6.0 mg/kg|
15987854|NCT02979431|Biological|ALX-0171 9.0 mg/kg|
15987855|NCT02979431|Other|Placebo|
15987856|NCT02979405|Drug|Phenylephrine|prophylactic infusion of phenylephrine 40 mcg/min
15987857|NCT02979392|Drug|TENPA (Targeting-Enhancing Nanoparticles of Paclitaxel)|TENPA IV once every 3 weeks (Phase I starting dose 75 mg/m2)
15987858|NCT02979379|Other|Pain|
15987859|NCT02979366|Drug|S64315 once a week|S64315 will be administered via i.v. infusion from 30 minutes and up to 3 hours once every week (21- day cycle), the starting dose is 50 mg. As data emerge during the study, the infusion duration and alternative dosing regimen may be changed.
15987860|NCT02979366|Drug|S64315 twice a week|S64315 will be administered via i.v. infusion from 30 minutes and up to 3 hours twice every week (28- day cycle), the starting dose is 50 mg. As data emerge during the study, the infusion duration and alternative dosing regimen may be changed.
15987861|NCT02979353|Behavioral|Shed-Meds: A Patient-Centered Deprescribing Intervention|The goal of the intervention is to safely deprescribe medications, as defined by dose reductions and stopped medications, based on a combination of clinical criteria and patient preferences.
15987862|NCT02979340|Procedure|MRI|non-invasive assessment of hepatic fibrosis and steatosis
15987863|NCT02979327|Drug|Adderall capsule|Amphetamine
15987864|NCT02979327|Drug|Placebo capsule|Placebo capsule
15987865|NCT02979314|Device|Galvanic Vestibular Stimulation|The investigators aim to study the influence of Galvanic Vestibular Stimulation on the brain mechanisms underlying illusory self-motion and its influence on egocentric mental transformation. As a control condition sham stimulation will be applied by the same device within the same participants in different trials. Participants should not note the difference.
15987866|NCT02979301|Drug|Tamoxifen|5 mg or 10 mg tamoxifen per day for 30 days.
15987867|NCT02979288|Drug|Lactobacillus casei rhamnosus (Lcr 35 regenerans)|Probiotic vaginal tablets vith active probiotic strains
15987868|NCT02979288|Other|NO Intervention|NO Intervention
15987869|NCT02979275|Procedure|Open heart surgery on cardiopulmonary bypass.|Brain oximetry and tissue saturation will be measured during operation. NGAL, cystatin-C, and Acute Kidney Injury Network (AKIN) criteria of AKI will be assessed durin first post-op day.
15987870|NCT02979262|Behavioral|Fathers for Change|
15987871|NCT02979262|Behavioral|Parent Education|
15987872|NCT02979249|Drug|Oral Iron|for one year
15987873|NCT02979236|Device|STENTYS Xposition S|
15987874|NCT02979223|Drug|sodium picosulfate and magnesium citrate, polyethylene glycol with ascorbic acid|"sodium picosulfate and magnesium citrate and 2L polyethylene glycol with ascorbic acid are used as combination method.
~There is a difference in the order of intake between two group"
15987875|NCT02979210|Other|Artificial Fecal Insult|protease/bile acid cocktail 200 microliters (1500 µg/ml trypsin/chymotrypsin protease mixture, 6.5 mg/ml cholic acid sodium, 6.2 mg/ml deoxycholic acid sodium, and 3.1 mg/ml chenodeoxycholic acid sodium in phosphate buffered saline
15987876|NCT02979210|Other|Phosphate Buffered Saline|200 microliters of phosphate buffered saline
15987877|NCT02979197|Drug|OE 10 mg amlodipine besylate tablet|
15987878|NCT02979197|Drug|OE 200 mg celecoxib capsule|
15987879|NCT02979197|Drug|Matched placebo for OE amlodipine besylate tablet|
15987880|NCT02979197|Drug|Matched placebo for OE celecoxib capsule|
15987881|NCT02979184|Other|Intensive decongestive physiotherapy|2 weeks of intensive decongestive physiotherapy
15987882|NCT02979171|Device|Laryngeal Mask Airway Classic|
15987883|NCT02979158|Procedure|CPB Low Dose|Performing CPB with low dose heparin and coated equipment
15987884|NCT02979158|Procedure|CPB High Dose|Performing CPB with high dose heparin and uncoated equipment
15987886|NCT02979132|Drug|Eisensulfat LOMAPHARM 50 mg|oral intake of an 'Eisensulfat LOMAPHARM 50 mg' tablet every morning for 90 days
15987887|NCT02979132|Drug|Ferinject(R)|Single-dose Ferinject(R) administration
15987888|NCT02979132|Dietary Supplement|iron fortified biscuits|consumption of an iron-fortfied biscuit every morning for 90 days
15987889|NCT02979106|Other|Test meal|Assessment of postprandial responses to a mixed meal containing fructose in carriers of one mutated ALDOB allele.
15987890|NCT02979093|Drug|Oxytocin|All women in both groups will receive 2 fMRIs according to our research protocol. Fifty minutes before the first fMRI, the women will administer nasal spray which will randomly contain either oxytocin or placebo. A month later the woman will return for the 2nd fMRI and administer nasal spray containing the substance they did not receive at the first scan. The randomization is double blinded with only the pharmacy knowing which nasal spray to provide at which fMRI visit.
15987891|NCT02979093|Drug|Placebos|All women in both groups will receive 2 fMRIs according to our research protocol. Fifty minutes before the first fMRI, the women will administer nasal spray which will randomly contain either oxytocin or placebo. A month later the woman will return for the 2nd fMRI and administer nasal spray containing the substance they did not receive at the first scan. The randomization is double blinded with only the pharmacy knowing which nasal spray to provide at which fMRI visit.
15987892|NCT02979080|Other|Eisensulfat LOMAPHARM 50 mg|Eisensulfat LOMAPHARM 50 mg administration for 120 days
15987893|NCT02979067|Procedure|Nasal oxygen flow|Nasal oxygen flow during apnoea
15987894|NCT02979054|Device|T4020|
15987895|NCT02979054|Device|Placebo|
15987896|NCT02979041|Behavioral|Interactive virtual reality training|"The proposed VR intervention program will provide active training to be performed individually 4 times a week for 20 minutes a session.
~The intervention program will be supervised by qualified, experienced physiotherapists, and will include individual training and two follow up meetings during the study period. The intervention program will include strengthening and endurance exercises for the cervical and shoulder girdle muscles. Training will include sensorimotor control and functional, quick, accurate, neck motion, using interactive VR training systems. This type of advanced training is very relevant to the pilots function in the cockpit as it includes interactive tasks aimed to increase range, speed, smoothness, accuracy, and control of cervical motion."
15987897|NCT02979041|Other|Standard Care|physiotherapy and medical care as provided currently
15987898|NCT02979028|Device|TEAS|Transcutaneous electrical acupoint stimulation
15987899|NCT02979015|Drug|alirocumab SAR236553 (REGN727)|"Pharmaceutical form: Solution for injection
~Route of administration: Subcutaneous"
15987900|NCT02979015|Drug|placebo|"Pharmaceutical form: Solution for injection
~Route of administration: Subcutaneous"
15987901|NCT02978989|Procedure|nonsolo LC|This patient is scheduled to undergo nonsolo laparoscpic cholecystectomy.
15987902|NCT02978989|Procedure|solo LC|This patient is scheduled to undergo solo laparoscpic cholecystectomy.
15987903|NCT02978976|Drug|Betamethasone|will receive two doses of 12mg betamethasone ( Dipropfos ® SCHERING-PLOUGH; Kenilworth, New Jersey, USA) intramuscularly (IM) 24 hours apart.
15987904|NCT02978976|Drug|saline|saline placebo injection in the same regimen.
15987905|NCT02978963|Behavioral|Cognitive behavioral therapy|CBT focused on reducing intolerance of uncertainty
15987906|NCT02978950|Other|Duplex ultrasound surveillance|bilateral lower extremity venous duplex
15987907|NCT02978950|Other|No ultrasound surveillance|will have daily exam and history as per normal clinical routine
15987908|NCT02978924|Device|tsDCS|20 min of treatment applied at the thoracic level (active electrode) with reference placed on the right shoulder
15987909|NCT02978911|Procedure|preoperative cerebral MRI and operative findings|
15987910|NCT02978885|Radiation|SPECT-CT imaging|Injection of AxV-128 labeled with 99mTc followed by SPECT CT
15987911|NCT02978885|Drug|AxV-128/Tc|Injection of AxV-128 labeled with 99mTc
15987912|NCT02978885|Procedure|Whipple procedure|"A Whipple procedure - also known as a pancreaticoduodenectomy - is a complex operation to remove the head of the pancreas, the first part of the small intestine (duodenum), the gallbladder and the bile duct.
~The Whipple procedure is used to treat tumors and other disorders of the pancreas, intestine and bile duct. It is the most often used surgery to treat pancreatic cancer that's confined to the head of the pancreas. After performing the Whipple procedure, your surgeon reconnects the remaining organs to allow you to digest food normally after surgery. Standard of care."
15987913|NCT02978885|Procedure|Major surgery|Additional surgical procedure(s) that is clinically indicated. Standard of care.
15987914|NCT02978859|Drug|MGCD516|Administered at 150 mg orally, daily, in continuous 21 day cycles. An orally available, potent small molecular inhibitor of several related receptor tyrosine kinases.
15987915|NCT02978846|Other|Clinical Observation|Undergo side effects evaluation using cards
15987916|NCT02978833|Biological|PRP|
15987917|NCT02978833|Biological|Whole Blood|
15987918|NCT02978833|Device|Ultrasound|
15987919|NCT02978820|Other|SEAS exercise|Patient were referred by medical doctor with a prescription of brace and exercise training for their moderate scoliotic curves. Patients were randomly divided into two groups. The SEAS group received SEAS exercises one times in a week for four months. In addition patients in SEAS groups were wearing spinal brace for their scoliosis in this period
15987920|NCT02978820|Other|CS exercise|Patient were referred by medical doctor with a prescription of brace and exercise training for their moderate scoliotic curves. Patients were randomly divided into two groups. The CS group received core stabilization exercise training one times in a week for four months. In addition patients in SEAS groups were wearing spinal brace for their scoliosis in this period
15987921|NCT02978807|Procedure|Point of care and venous screening|
15987922|NCT02978781|Drug|SAGE-217|SAGE-217 Oral Solution
15987923|NCT02978781|Drug|SAGE-217|SAGE-217 Capsules
15987924|NCT02978781|Drug|Placebo|SAGE-217 matching placebo capsules
15987925|NCT02978768|Other|Exercise|First year, the investigators investigate the effect of 12-week Tai Chi 6-Form accompanied with music rhythm for patients with mild and moderate AD in behavioral and general health, functional and cognitive decline.
15987926|NCT02978768|Device|Computer-based cognitive training|Second year, the investigators investigate the effect of 12-week computer-based cognitive training games for patients with mild and moderate AD in behavioral and general health, functional and cognitive decline.
15987927|NCT02978768|Device|Physico-Mental rehabilitation Wii|Third year, the investigators investigate the effect of 12-week Physico-Mental rehabilitation Wii (PM Wii) for patients with mild and moderate AD in behavioral and general health, functional and cognitive decline.
15987928|NCT02978755|Drug|GM102|GM102 escalating doses (phase1)
15987929|NCT02978755|Drug|Paclitaxel + carboplatin|GM102 escalating doses combined with paclitaxel and carboplatin
15987930|NCT02978755|Drug|GM102|GM102 single agent at recommended dose in 3 parallel cohorts (sex cord, epithelial ovarian, cervix cancers)
15987931|NCT02978742|Behavioral|Adaptive Recovery Record App|Participants will use the Recovery Record smartphone app, which is a meal monitoring tool, that incorporates discrete reminders, motivational tools, social support, summative feedback, and coping skill suggestions. Participants will also receive tailored, algorithm-generated content in a structured manner that mimics the progression of psychotherapy (e.g., checking in with users, reminding them of their reasons for wanting to recover, and working towards goals) over the course of 8 weeks.
15987932|NCT02978742|Behavioral|Standardized Coaching|Coaches (dietitians or mental health clinicians) will review patients' logs daily and participants will receive one communication of standardized feedback each day through the app based on their food records. A standardized feedback manual to be used by coaches has been developed by co-investigators (two PhD psychologists and one psychiatrist), and all feedback will be monitored for consistency and quality by co-investigators.
15987933|NCT02978729|Other|Two-way videoconference remote genetic counseling|
15987934|NCT02978729|Other|Telephone remote genetic counseling|
15987935|NCT02978716|Drug|Trilaciclib|G1T28
15987936|NCT02978716|Drug|Gemcitabine|Gemcitabine
15987937|NCT02978716|Drug|Carboplatin|Carboplatin
15987938|NCT02978703|Drug|COPD Pharmacologic Substance|COPD patients treated by Fluticasone / Salmetrol via Elpenhaler device
15987939|NCT02978690|Drug|BI655130|
15987940|NCT02978677|Radiation|Radiotherapy 68 Gy(RBE)|Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 18 Gy(RBE) proton
15987941|NCT02978677|Radiation|Radiotherapy 72 Gy(RBE)|Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 18 Gy(RBE) proton and boost 2 to 4 Gy(RBE) proton
15987942|NCT02978677|Radiation|Radiotherapy 60 Gy(RBE)|Radiotherapy 2.0 to 50 Gy(RBE) photon or proton and boost 2 to 10 Gy(RBE) proton
15987943|NCT02978664|Procedure|Air insufflation|Air insufflation during colonoscopy including insertion phase
15987944|NCT02978664|Procedure|water immersion|Water will infused during insertion phase and removed during withdrawal phase of colonoscopy.
15987945|NCT02978664|Procedure|Water exchange|Water will infused and removed during insertion phase of colonoscopy
15987946|NCT02978651|Drug|Pitolisant (BF2.649)|
15987947|NCT02978651|Drug|Placebo Oral Tablet|
15987948|NCT02978638|Device|Finetech Vocare Bladder System|Participants will be implanted with the existing FDA-approved Finetech Vocare Bladder System stimulator and electrodes.
15987949|NCT02978625|Other|Laboratory Biomarker Analysis|Correlative studies
15987950|NCT02978625|Biological|Nivolumab|Given IV
15987951|NCT02978625|Biological|Talimogene Laherparepvec|Given IT
15987952|NCT02978612|Drug|Capecitabine|Capecitabine is a prodrug to 5-fluorouracil. It is used for adjuvant chemotherapy after surgery for colon cancer. The tablets are either 150 mg or 500 mg
15987953|NCT02978599|Drug|AVL-3288|daily for 5 days
15987954|NCT02978599|Drug|Placebo|daily for 5 days
15987955|NCT02978586|Device|[Ga-68]PSMA PET/MR|All participants will undergo at least 1 baseline [Ga-68]PSMA PET/MR. If participants test positive for [Ga-68]PSMA tumor uptake, they will under up to 2 additional scans
15987956|NCT02978573|Device|Cartiva|Cartiva Synthetic Cartilage Implant
15987957|NCT02978560|Device|fluorescence-mediated photoplethysmography|Indocyanine green dye (ICG) will be injected intravenously as a sterile solution at a dose of 0.5 mg/kg, and then imaging of skin will be done with a fluorescence camera. The ICG-angiogram sequence will consist of 1.5 x 2.0-cm field-of-view ICG fluorescence images acquired at the rate of approximately 30/sec during a period of about 15 seconds. Following acquisition of the initial transit angiogram sequence, several additional 15-second-long image sequences will be acquired during the next half-hour, but without any additional injections.
15987958|NCT02978547|Drug|Metformin Hydrochloride 500Mg Tablet|In the event of any grade 2 toxicities (with the exception of hyperglycemia), metformin will be withheld until improvement to ≤ grade 1, then restarted at a dose of 500 mg daily. In the event of grade ≥ 3 toxicities related to metformin, treatment will be discontinued. Metformin therapy will also be discontinued if serum lactate levels are above normal values.
15987959|NCT02978534|Drug|Quetiapine|Quetiapine concentrations will be observed in women who have already (under the guidance of a physician) decided to continue taking Quetiapine for the treatment of Bipolar Disorder (any subtype) or Schizophrenia during pregnancy.
15987960|NCT02978521|Other|Pulmonary rehabilitation|Session 1: ventilatory pattern training Session 2,3: ventilatory pattern + respiratory training with incentive spirometer Session 4-6: Sessions 1-3 training continues + training with Positive expiratory pressure device (Threshold PEP) and breathing trainer Threshold IMT) Sessions 7-9: Continue respiratory training + resistance training with RECK MOTOmed2 ergometer at a 30% intensity until 60% is achieved Session 10-12: Continue with previous training + treadmill training
15987961|NCT02978508|Drug|Permethrin Cream, 5%|Subjects on Test product will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.
15987962|NCT02978508|Drug|Elimite|Subjects on RLD will receive a maximum of two doses, 60 g each, during the study. The first dose will be applied on Day 1 in an outpatient setting, after the visit to the clinical site (preferably in the evening). The second dose will be applied on Day 14±2 only if retreatment is necessary.
15987963|NCT02978495|Drug|Doxorubicin|Doxorrubicin 60 mg/m2 4 cycles each 21 days
15987964|NCT02978495|Drug|Carboplatin|Carboplatin AUC 1,5 once a week, for 12 weeks
15987965|NCT02978495|Drug|Paclitaxel|80mg/m2 weekly for 12 weeks
15987966|NCT02978495|Drug|Cyclophosphamide|600mg/m2 4 cycles each 21 days
15987967|NCT02978482|Drug|durvalumab|durvalumab (MEDI4736) 20mg/kg via IV infusion every 4 weeks until confirmed disease progression or unacceptable toxicity
15987968|NCT02978482|Drug|tremelimumab + durvalumab|20 mg/kg durvalumab (MEDI4736) via IV infusion q4w and 1 mg/kg tremelimumab via IV infusion q4w for up to 4 doses/cycles, and then continue 20 mg/kg durvalumab (MEDI4736) q4w starting on Week 16 for up to confirmed disease progression
15987969|NCT02978469|Other|Life style changing: reducing sedentary behavior|"The program includes 23 meetings held once per week (with holiday breaks). Each meeting lasts 90 minutes, consisting of exercise training.
~the group will meet for information providing and discussion. Participants are guided in the process of creating a focussed individualized activity plan.
~In the group setting they will experience a variety of activities enabling them to explore activities they prefer: each participant receive three personal consultation meetings. The group will experience sport and recreational activities with persons with physical impairments. Also activities in sport in community facilities."
15987970|NCT02978456|Device|quantitative coronary angiography guided coronary intervention with sirolimus-eluting Orsiro/Orsiro mission stent|In the quantitative coronary angiography-guided group, sirolimus-eluting Orsiro/Orsiro mission stent size and length is chosen to cover the entire length of the culprit lesions according to quantitative coronary angiography measurements. Selection of the sirolimus-eluting Orsiro/Orsiro mission stent size should be guided by both quantitative coronary angiography measurement and visual estimate, and is recommended to be based on distal reference vessel diameter by quantitative coronary angiography (distal reference vessel diameter by quantitative coronary angiography plus ~10% of distal reference vessel diameter).
15987971|NCT02978456|Device|intravascular ultrasound guided coronary intervention with sirolimus-eluting Orsiro/Orsiro mission stent|In the intravascular ultrasound -guided group, sirolimus-eluting Orsiro/Orsiro mission stent size and length is selected by intravascular ultrasound measurements.
15987972|NCT02978443|Drug|Nivolumab|nivolumab administered IV over 60 minutes at 1 mg/kg every 3 weeks for 4 treatment cycles (Induction) then continue with nivolumab administered IV over 60 minutes at 3 mg/kg every 2 weeks
15987973|NCT02978443|Drug|Ipilimumab|ipilimumab administered IV over 90 minutes at 3 mg/kg every 3 weeks for 4 treatment cycles (Induction)
15987974|NCT02978430|Device|Computer-assisted GDFT|Patients receive fluid therapy via a computer-assisted goal-directed fluid therapy (GDFT) prototype closed-loop (automated) system guided by a cardiac output monitor.
15987975|NCT02978430|Other|Standard of care|Patients receive fluid management based only on static variables (e.g. arterial pressure, heart rate, CVP, and urine output). This control group (started retrospectively before the first included patient of the closed-loop goal directed fluid therapy group) consists of the same population undergoing the same surgery as the closed-loop GDFT group.
15987976|NCT02978417|Drug|Naltrexone for extended-release injectable suspension|Opioid-dependent Drug Court clients enrolled in the study will receive monthly injections of Vivitrol for up to 12 months if they continue to be medically eligible and willing.
15987977|NCT02978417|Drug|Oral naltrexone|Opioid-dependent Drug Court clients enrolled in the study will receive prescriptions for oral naltrexone for up to 12 months if they continue to be medically eligible and willing.
15987978|NCT02978404|Drug|Nivolumab|Nivolumab is administered to patients to a maximum of 2 year.
15987979|NCT02978404|Radiation|Radiosurgery|Up to 10 cubic centimeter of brain metastases will be treated with radiosurgery. The dose of radiosurgery depends on the size of individual metastases.
15987980|NCT02978391|Procedure|endoscopic adhesive powder|
15987981|NCT02978391|Drug|epinephrine|
15987982|NCT02978391|Device|Endoscopic Wound Dressing (Next Biomedical)|
15987983|NCT02978378|Other|biomarker levels|The level of the biomarker hyaluronic acid will be measured
15987984|NCT02978365|Other|Questionnaires|Patients will fill self-reported functional shoulder scales (1. Western Ontario Shoulder Instability index - WOSI, and 2. Disabilities of Arm, Shoulder and Hand questionnaire - DASH), as well as a Fear Avoidance Belief Questionnaire (FABQ).
15987985|NCT02978365|Device|Isokinetic Strength Measurement|Isokinetic strength will be measured using a Biodex Isokinetic System 4.0 (Shirley, NY)
15987986|NCT02978352|Other|learning|
15987987|NCT02978339|Drug|Curcumin|Subjects will receive one 750 mg softgel by mouth twice a day for 12 weeks. Each each 750 mg CuraMed® softgel supplies 500 mg of highly bioavailable BCM-95 curcumin.
15987988|NCT02978326|Drug|SAGE-217|
15987989|NCT02978326|Drug|Placebo|
15987990|NCT02978313|Drug|Cetuximab|anti-EGFR monoclonal antibody
15987991|NCT02978313|Drug|mFOLFOX6|Oxaliplatin+LV5FU2
15987992|NCT02978313|Drug|FOLFIRI|Irinotecan+LV5FU2
15987993|NCT02978300|Device|NIV/HFNC|Pressure support level to achieve an expired tidal volume between 6 and 8 ml/kg of predicted body weight Positive end expiratory pressure from 5 to 10 cm H2O, aiming a PEEP level ≥ 8 cm H2O FiO2 set to achieve SpO2 ≥ 92%
15987994|NCT02978300|Device|HFNC|Gas flow of 60 l/min and FiO2 set to achieve SpO2 ≥ 92%
15987995|NCT02978287|Drug|BAVU Solution|Tissue preservation solution for transplantation
15987996|NCT02978274|Drug|MMF|MMF withdrawal by engraftment post haplo-SCT
15987997|NCT02978274|Drug|MMF|MMF withdrawal by 2 month post haplo-SCT
15987998|NCT02978261|Drug|PLB1001|PLB1001 is a capsule in the form of 25 mg and 100mg, twice daily.
15987999|NCT02978235|Drug|TAS4464|Intravenous (IV) Infusion
15988000|NCT02978222|Biological|FRα peptide plus Adjuvant (GM-CSF)|Intradermal injection FRα peptides, 500μg each - plus GM-CSF 125 μg
15988001|NCT02978222|Drug|Adjuvant (GM-CSF) Alone|Intradermal injection 125 μg GM-CSF
15988002|NCT02978209|Device|7.5 %|Patient untreated with moisturizers for 1-2 weeks will start applying moisturizers containing urea at concentration 0 % on one half of the body twice a day while applying the same moisturizer with 7.5 % urea on the other half of the body in the same quantity at the same frequence
15988003|NCT02978196|Procedure|Injection of 99m-Tc-NM-01|Patient is injected with micro-dose of 99m-Tc-NM-01
15988004|NCT02978183|Biological|ST266|One (1) drop of 1X ST266 ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
15988005|NCT02978183|Drug|Saline (0.9% NaCl)|One (1) drop of saline ophthalmic eye drops will be administered to each eye 4 times a day for 8 days.
15988006|NCT02978170|Procedure|Cone-Beam Computed Tomography|Undergo CBCT
15988007|NCT02978157|Drug|esomeprazole+amox+levo|esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d.
15988008|NCT02978157|Drug|esomeprazole+bismuth+tetra+levo|esomeprazole 40 mg b.d., bismuth 120 mg q.d.s., tetracycline 500 mg q.d.s., and levofloxacin 500 mg o.d.
15988009|NCT02978144|Radiation|SPECT-CT imaging|Injection of AxV-128 labeled with 99mTc followed by SPECT-CT
15988010|NCT02978144|Drug|AxV-128/Tc|Injection of AxV-128 labeled with 99mTc
15988011|NCT02978131|Other|Histopathological study|
15988012|NCT02978131|Other|Molecular study (Polymerase chain reaction)|
15988014|NCT02978105|Other|self-conditioning techniques|Self-hypnosis to increase self-control before meals and every food compulsion episode
15988015|NCT02978105|Other|standard care (diet, exercise and behavioral therapy)|dietary recommendations, exercise recommendations, and behavioral recommendations
15988016|NCT02978079|Device|Automated pupillometry|Automated pupillometry will be performed in patients with acute stroke with the intention of diagnosing Horner's syndrome
15988017|NCT02978066|Other|Spinal anaesthesia|
15988018|NCT02978053|Behavioral|Bright light|Bright light for 30 minutes during night shifts (between 2 AM and 3 AM the first night, between 3 AM and 4 AM the second night, between 4 AM and 5 AM the third night).
15988019|NCT02978053|Behavioral|Red light|Red light for 30 minutes during night shifts (between 2 AM and 3 AM the first night, between 3 AM and 4 AM the second night, between 4 AM and 5 AM the third night).
15988020|NCT02978040|Drug|Cangrelor|Cangrelor will be administered as bolus of 30 µg/Kg followed by infusion at 4 µg/Kg/min for 2 h (or to the end of PCI); at the end of infusion, oral prasugrel at loading dose of 60 mg will be administrated, then 10 mg daily (5 mg daily if body weight < 60 kg or age > 75 years old).
15988021|NCT02978040|Drug|Tirofiban|Tirofiban will be administrated as 25 µg/Kg bolus followed by infusion at 0.15 µg/Kg/min for 2 h (or to the end of PCI) (infusion rate of 0.075 µg/Kg/min for patients with creatinine clearance < 60 ml/min); at the end of infusion, oral prasugrel at loading dose of 60 mg will be administrated, then 10 mg daily (5 mg daily if body weight < 60 kg or age > 75 years old) .
15988022|NCT02978040|Drug|Prasugrel|In the prasugrel arm no intravenous anti-platelet drug will be administered. Patients will be randomized to oral integer prasugrel or chewed oral prasugrel at an identical loading dose of 60 mg, then 10 mg daily (5 mg daily if body weight < 60 kg or age > 75 years old).
15988023|NCT02978027|Behavioral|Brief Advice|
15988024|NCT02978027|Behavioral|NIAAA Clinician's Guide|
15988025|NCT02978027|Behavioral|Motivational Interviewing (MI)|
15988026|NCT02978014|Device|ProSpare|A novel rectal obturator (ProSpare) acting as a non-invasive daily on-line image guided tool, a rectal spacer and a prostate bed stabiliser
15988027|NCT02978001|Other|Stabile Isotope tracers|Non-radioactive tracers used in hyperinsulinaemic euglycaemic clamp
15988028|NCT02977988|Behavioral|Mindfulness Meditation|MBRP-W is delivered in 12 bi-weekly 80-minute group sessions. Facilitators with previous experience in MBSR and trained in MBRP-W will deliver each group. Each session has a central theme and is divided into five segments consisting of: (a) a welcome meditation or other mindfulness practice, (b) a review of session objectives, (c) a brief didactic psycho-educational presentation and discussion based on the session's theme, (d) experiential and formal meditation or other practices, and (e) readings and assignments for the next class. Participants are expected to learn skill building techniques to reducing stress using mindfulness-based principles to complement their recovery treatment program.
15988029|NCT02977988|Behavioral|Brain and Recovery (B&R)|B&R is delivered in 12 bi-weekly 80-minute group sessions delivered by two trained interventionists. The B&R group will receive didactic education on the neurobiology of addiction. B&R contains no information on behavior change, stress reduction, or mindfulness-based or relapse-related content. The intervention was developed over three years with a population similar to those in the study and with input from patients and experts on neurobiology of addiction. Topics include: (1) brain structures and functions related to addiction, (2) effects of various types of substances on the brain, and (3) rewarding effects and how these lead to addiction. Participants are expected to gain knowledge pertaining to the effects of drugs on the brain.
15988030|NCT02977975|Other|Raw sauerkraut|Sauerkraut fermentations have been shown to contain a broad range of microorganisms, including Leuconostoc mesenteroides, Lactobacillus plantarum, Leuconostoc citreum, Leuconostoc argentinum, Lactobacillus paraplantarum, and Lactobacillus coryniformis. Some of these bacteria, such as Lactobacillus plantarum, are classified as probiotics.
15988031|NCT02977975|Other|Pasteurized sauerkraut|Sauerkraut without live bacteria.
15988032|NCT02977962|Behavioral|Cognitive-Behavior Therapy|This therapy has been designed for adolescents with high functioning ASD and involves 16 weekly session where the participant learns coping skills related to addressing anxiety (e.g., exposure therapy, cognitive therapy, social skills training).
15988033|NCT02977962|Other|Treatment as Usual|Those who choose to participate will be enrolled in the 16 week study. They will required to attend 3 assessments - pre-treatment (week 0), mid-treatment (week 8), and post-treatment (week 16). Those in this group will not receive the Cognitive-Behavior Therapy, and instead will undergo therapy for their anxiety as they usually would, whether by using medication or working with a therapist.
15988034|NCT02977949|Drug|Raloxifene|
15988035|NCT02977936|Dietary Supplement|Cartimotil Fort|1 to 4 capsules per day during 90 days
15988036|NCT02977923|Device|VR distraction via Oculus Rift|In addition to standard pharmacological treatment, Virtual reality distraction through the use of Oculus Rift® will be used as the experimental intervention. The Oculus Rift (Consumer version) is made of two Oled panels with a resolution of 1200p running at 90Hz. It has very effective 360 degree positional tracking and integrated 3D audio. These combine to produce a high level of immersion, with high photorealism while maintaining the low latency necessary to induce presence and prevent cybersickness. The child, depending on the site of the injury, will have the opportunity to interact with the game. Video games, approved by healthcare professionals with extensive experience in pediatrics, were adapted for children and tailored to minimize cyber sickness.
15988037|NCT02977923|Other|Standard pharmacological treatment|according to the unit's protocol and adjusted to each participant's age, weight and condition by the anesthetist and pain clinic nurse.
15988038|NCT02977910|Procedure|repair of deltoid ligament|intraoperative repair of deltoid ligament combined with ORIF
15988039|NCT02977897|Drug|Octreotide Acetate|Octreotide 100mcg SC q12h for 5 days
15988179|NCT02976766|Drug|Gypenosides|Participants will receive gypenosides 360 mg/day (120 mg three times a day) for 10 days.
15988040|NCT02977884|Behavioral|The Complete Health Improvement Program|CHIP focuses on food, diet, activity, exercise, stress management, by viewing videos, cooking demonstrations, discussion, and exercise. Intervention nurtures intelligent self-care through enhanced understanding of the epidemiology, etiology, and risk factors associated with chronic lifestyle related diseases. The primary focus is the consumption of plant-based whole foods, such as fresh fruits, vegetables, whole grains, legumes, and nuts. The goal was to keep dietary fat below 20% of total calories, daily intake of added sugar below 10 tsps, sodium below 2,000 mg, and cholesterol below 50 mg. High fiber food intake (>35 g/day) is encouraged, and flexibility exercises, a daily walk of 30 minutes or 10,000 steps and daily use of stress management techniques.
15988041|NCT02977871|Procedure|Bladder flap|Performing uterine incision and cesarean section with a bladder flap.
15988042|NCT02977858|Other|Educational practice for HCPs,Dissemination only|Study participants are health care professionals (HCPs) who will be provided educational material and complete knowledge assessments
15988043|NCT02977858|Other|Educational practice for HCPs,Spaced Education|Study participants are health care professionals (HCPs) who will be provided educational material via a Spaced Education program; participants will subsequently complete knowledge assessments
15988044|NCT02977845|Behavioral|Qigong|"Qigong has long been regarded as a form of mind-body intervention in Traditional Chinese Medicine (TCM), which simultaneously exercises the mind and the body for treating many chronic diseases and promoting wellness. About a hundred million people are currently practicing Qigong in China. Qigong is now regarded as a form of self-practise mind-body exercise and recently relevant to sports activity, which is officially known as Health Qigong. It is different from Medical Qigong which involves a TCM practitioner to emit Qi to heal the patients."
15988045|NCT02977832|Dietary Supplement|Odyliresin|Odyliresin 2 ml, 20 drops once daily and alpha-antagonist (alfuzosin 10 mg)
15988046|NCT02977832|Drug|Alfuzosin|10Mg Oral Tablet, Extended Release
15988047|NCT02977819|Other|Meditation practice|18 months
15988048|NCT02977819|Other|Learning English as a foreign language|18 months
15988049|NCT02977793|Device|Tomey EM-4000 Specular Microscope|
15988050|NCT02977793|Device|Konan CellChek XL Specular Microscope|
15988051|NCT02977780|Drug|Temozolomide|Temzolomide capsules
15988052|NCT02977780|Drug|Neratinib|Neratinib tablets
15988053|NCT02977767|Procedure|Conversational hypnosis|Conversational hypnosis starts since the enter of the nurse in patient's room and last since the nurse leaves the room. Change of canula is performed under conversational hypnosis.
15988054|NCT02977754|Other|This is an observational study|Imaging
15988055|NCT02977741|Drug|Olanzapine|
15988056|NCT02977728|Other|Olfactory Evaluation|The investigators will evaluate the olfactory system of all participants by the use of the Sniffin'Sticks batterie
15988057|NCT02977715|Biological|IMVAMUNE|Two doses of attenuated live virus smallpox vaccine (IMVAMUNE liquid formulation or lyophilized formulation) administered on days 0 and 28 via subcutaneous injection (deltoid) (1 x 108 Tissue Culture Infectious Dose 50 [TCID50] per 0.5 mL)
15988058|NCT02977689|Drug|IDH305|study drug used to inhibit IDH1 mutation in these tumors, resulting in anti-tumor activity.
15988059|NCT02977663|Other|Magnetic Resonance Imaging (MRI)|"Chest MRI during the MRI cerebral
~2 tubes of blood taken during the medical visit"
15988060|NCT02977650|Procedure|Endoscopic ultrasonography-guided fine needle aspiration|
15988061|NCT02977637|Procedure|Feraheme MRI/MRA|
15988062|NCT02977624|Behavioral|The Cognitive Orientation to daily Occupational Performance|
15988063|NCT02977611|Drug|Iron sucrose|Iron sucrose will be infused at dose of 500 mg over a one hour period
15988064|NCT02977585|Device|10 cmH2O peep|positive end expiratory pressure
15988065|NCT02977572|Device|Non-Invasive Ventilation|In arm description
15988066|NCT02977572|Device|Continuous Positive AirwayPressure CPAP|In arm description
15988067|NCT02977559|Device|Laryngeal Tube Suction Disposable|Device for ventilation
15988068|NCT02977559|Device|Laryngeal Mask Airway AuraGain|Ventilation device
15988069|NCT02977546|Device|Noninvasive pulse contour analysis|For noninvasive pulse contour Analysis we use the CNAP-Monitor (CNSystems Medizintechnik AG, Graz, Austria)
15988070|NCT02977546|Device|Pulmonary artery catheterization|As a reference method we use the Goldstandard intermittent thermodilution via a PAC which is regularly performed during the patients Hospital stay
15988071|NCT02977533|Drug|GZ402668|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
15988072|NCT02977533|Drug|Placebo|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
15988073|NCT02977533|Drug|Acyclovir|"Pharmaceutical form: tablet
~Route of administration: oral"
15988074|NCT02977520|Procedure|Printing, Three-Dimensional|To establish 3D model of cerebral aneurysms and have preoperative evaluation.
15988075|NCT02977507|Other|Lytera 2.0|Lytera 2.0 applied to the affected areas twice a day, in the morning and evening, every day for 12 weeks.
15988076|NCT02977507|Drug|4% Hydroquinone Topical Cream|4% Hydroquinone Topical Cream applied to the affected areas twice a day, in the morning and evening, every day for 12 weeks.
15988077|NCT02977507|Other|SkinMedica Facial Cleanser|SkinMedica facial cleanser applied to the face as directed.
15988078|NCT02977507|Other|SkinMedica Rejuvenative Moisturizer|SkinMedica rejuvenative moisturizer applied to the face as directed.
15988079|NCT02977507|Other|SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen|SkinMedica Essential Defense Mineral Shield Broad Spectrum SPF 35 sunscreen applied to the face as directed.
15988080|NCT02977494|Drug|Daratumumab|Daratumumab (JNJ-54767414) is a novel human IgG1monoclonal Antibody (mAb) that binds with high affinity to a unique epitope on CD38
15988081|NCT02977494|Drug|Bortezomib|
15988082|NCT02977494|Drug|Dexamethasone|
15988083|NCT02977468|Drug|Merck 3475 Pembrolizumab|Participants receive Pembrolizumab by vein over about 30 minutes on Day 1 of one to two cycles.
15988084|NCT02977468|Radiation|Intraoperative radiation therapy (IORT)|Participants will receive Intraoperative radiation therapy (IORT) on the day of surgery.
15988085|NCT02977442|Behavioral|exercise|
15988086|NCT02977429|Other|standardized fluid therapy|The patients with ScvO2 <70% will receive the standardized fluid therapy for 6 hours.
15988087|NCT02977429|Other|conventional fluid therapy|The patients with ScvO2 ≥ 70% will receive the conventional fluid therapy.
15988091|NCT02977390|Other|Passive leg raise|By tilting the patient's bed from sitting 45 degrees to supine with legs tilted up 45 degrees we recruit the blood volume in the legs and can measure a reversible fluid challenge on stroke volume.
15988092|NCT02977377|Other|Exercise therapy|Cases will take the treatment 1-hour, 3 days in a week for 8 weeks.
15988093|NCT02977377|Other|Whole body vibration|4 sets, 1 min application and 1min rest whole body vibration and after that exercises. Cases will take the treatment 1-hour, 3 days in a week for 8 weeks.
15988094|NCT02977364|Drug|HS-10241|
15988095|NCT02977351|Procedure|Non-surgical periodontal treatment|
15988096|NCT02977338|Other|Retrospective review|
15988097|NCT02977325|Other|water cure|
15988098|NCT02977312|Drug|Imatinib|Observation of chronic myeloid leukemia (CML) patients in chronic phase (CP) treated with Cemivil
15988099|NCT02977299|Drug|Aripiprazole|Oral adjunctive therapy with aripiprazole, dose adjusted for effectiveness and tolerability.
15988100|NCT02977299|Device|Repetitive transcranial magnetic stimulation (rTMS)|Adjunctive therapy with transcranial magnetic stimulation, dose adjusted for effectiveness and tolerability.
15988101|NCT02977299|Drug|Venlafaxine XR|Oral switch therapy with venlafaxine, dose adjusted for effectiveness and tolerability.
15988102|NCT02977286|Drug|Naloxegol Oral Tablet|Naloxegol Oral Tablet 25 mg (or 12.5 mg) po (enteral) daily
15988103|NCT02977286|Drug|Placebo Oral Tablet|Placebo Oral Tablet po (enteral) twice daily
15988104|NCT02977286|Drug|Docusate Sodium 100 Mg oral capsule [Colace]|Docusate Sodium 100 mg po (enteral) twice daily
15988105|NCT02977286|Drug|Senna 217 Mg Oral Tablet|Senna 127 mg oral tablet daily if no spontaneous bowel movement >/=3 days after scheduled opioid initiation; increase to two senna 127 mg tables if no no spontaneous bowel movement >/=4 days after scheduled opioid initiation. Repeat two senna 127 mg tablets if no spontaneous bowel movement >/=5 days after scheduled opioid initiation. Repeat two senna 127 mg tablets if no spontaneous bowel movement >/=6 days after scheduled opioid initiation.
15988106|NCT02977286|Drug|Polyethylene Glycols|Polyethylene Glycols 17 g daily if no spontaneous bowel movement >/=3 days after scheduled opioid initiation; increase to 34 g daily if no spontaneous bowel movement >/=4 days after scheduled opioid initiation. Repeat 34 g daily if no spontaneous bowel movement >/= 5 days after scheduled opioid initiation. Repeat 34 g daily if no spontaneous bowel movement >/= 6 days after scheduled opioid initiation.
15988107|NCT02977286|Drug|Bisacodyl 10 mg Suppository|Insert one suppository if no spontaneous bowel movement >/=4 days after scheduled opioid initiation. Repeat if no spontaneous bowel movement >/= 5 days after scheduled opioid initiation. Repeat if no spontaneous bowel movement >/= 6 days after scheduled opioid initiation.
15988108|NCT02977286|Drug|Magnesium Citrate Oral Liquid Product|Administer one 10 oz bottle if no spontaneous bowel movement >/= 5 days after scheduled opioid initiation.
15988109|NCT02977286|Drug|Methylnaltrexone|Administer 8 mg or 16 mg (depending on subject's weight) subcutaneously x 1 if no spontaneous bowel movement >/= 6 days after scheduled opioid initiation, consult surgery/gastroenterology and discontinue study medication.
15988110|NCT02977273|Other|Thin/100% Portion|Thin textured rice meal (ground rice grains) served in a regular portion size (100 %: 700g)
15988111|NCT02977273|Other|Thin/150% Portion|Thin textured rice meal (ground rice grains) served in a larger portion size (150 %: 1050g)
15988112|NCT02977273|Other|Thick/100% Portion|Thick textured rice meal (whole rice grains) served in a regular portion size (100 %: 700g)
15988113|NCT02977273|Other|Thick/150% Portion|Thick textured rice meal (whole rice grains) served in a larger portion size (150 %: 1050g)
15988114|NCT02977260|Other|Thin/Low Energy|Thin textured rice meal (ground rice grains) with lower energy density (0.57 kcal/g)
15988115|NCT02977260|Other|Thin/High Energy|Thin textured rice meal (ground rice grains) with higher energy density (1.01 kcal/g)
15988116|NCT02977260|Other|Thick/Low Energy|Thicker textured rice meal (whole rice grains) with lower energy density (0.57 kcal/g)
15988117|NCT02977260|Other|Thick/High Energy|Thicker textured rice meal (whole rice grains) and high energy density (1.01 kcal/g)
15988118|NCT02977247|Other|Non-Interventional|Only standard care procedures will be performed for clinical intervention and diagnostic purposes.
15988119|NCT02977247|Device|Automated Whole Breast Ultrasound|Bilateral breast ultrasound images will be captured, but not clinically evaluated for diagnostic purposes by a physician.
15988120|NCT02977234|Drug|Isoamyl 2-Cyanoacrylate|
15988121|NCT02977221|Procedure|Piezosurgery|The device tip will be used to to create small vertical incisions into the cortex of the dento-alveolar process of the lower anterior teeth.
15988122|NCT02977208|Procedure|Sparse blood sampling|Blood samples are being collected at times 0, 90 and 240 minutes after gabapentin administration.
15988123|NCT02977208|Procedure|Urine sampling|Urine samples are being collected during the dosing interval, only in patients hospitalized at Hospital Estadual de Américo Brasiliense (HEAB).
15988124|NCT02977208|Procedure|DNA extraction|Blood sample are being collected for DNA extraction. DNA are being extracted from the whole blood of all patients for genotyping of the SLC22A2 c.808G>T and SLC22A4 c.1507C>T polymorphisms
15988125|NCT02977208|Drug|Gabapentin|All patients undergoing chronic treatment with gabapentin are being recruited.
15988126|NCT02977195|Drug|NP137|Treatment will be administered as long as patient experiences clinical benefit in the opinion of the investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent.
15988127|NCT02977182|Other|Complete Decongestive Therapy (CDT)|CDT is a multimodal therapy consisting of four components: manual lymph drainage, compression wrapping, exercise, and skin care
15988128|NCT02977169|Radiation|PORT|3-dimensional conformal or intensity-modulated radiotherapy, total dose of 50.4 Gy, 1.8 Gy once daily over 5.5 weeks, following the standard and consistent PORT CTV delineation guideline
15988180|NCT02976766|Drug|Placebo|Participants will receive placebo three times a day for 10 days.
15988129|NCT02977169|Drug|Platinum-based two drug chemotherapy (cisplatin/carboplatin + vinorelbine or cisplatin/carboplatin + pemetrexed regimen)|Cisplatin/ carboplatin + vinorelbine regimen for squamous cell lung carcinoma Cisplatin/carboplatin + pemetrexed regimen for lung adenocarcinoma
15988130|NCT02977156|Biological|Pexa-Vec|IT Injections will be performed by a radiologist using imaging-guidance, ultrasound or computed tomography (CT). The dose to be injected could be divided between 1 to 5 tumor lesions.
15988131|NCT02977156|Drug|Ipilimumab|IT Injections will be performed by a radiologist using imaging-guidance, ultrasound or computed tomography (CT). The dose to be injected could be divided between 1 to 5 tumor lesions.
15988132|NCT02977143|Procedure|Fluid loading of volulyte 300 ml|Administration of volulyte 300 ml and measurement of increase in cardiac index
15988133|NCT02977130|Behavioral|Map group|diabetes shared care plus conversation map intervention
15988134|NCT02977130|Behavioral|Control group|diabetes shared care
15988135|NCT02977117|Other|Dialysate magnesium (1.0 mmol/L)|Dialysate magnesium will be increased from 0.5 mmol/L to 1.0 mmol/L for 4 weeks after which subjects will return to dialysate magnesium 0.5 mmol/L for 2 weeks observation.
15988136|NCT02977117|Other|Dialysate magnesium (0.5 mmol/L)|Dialysate magnesium will be maintained at 0.5 mmol/L for the duration of the trial.
15988137|NCT02977104|Other|Maestro ECG|Telemetry is obtained through the Maestro handheld ECG device.
15988138|NCT02977091|Other|change in fitness level|fitness level assessed by the Euro-fit tests for school age children.including 1.body fat 2. single leg balance test 3.Plate Tapping -for speed of limb movement 4.Sit-and-Reach flexibility test 5. Standing Broad Jump - measures explosive leg power. 6.Handgrip Test - measures static arm strength 7.Sit-Ups in 30 seconds - measures trunk strength 8.Bent Arm Hang - muscular endurance/functional strength 9.20 m endurance shuttle-run - cardiorespiratory endurance Wingate anaerobic test which is a 30 seconds maximum pedaling against resistance on bike for evaluating the anaerobic fitness
15988139|NCT02977078|Behavioral|Active feedback on monitored inhaler use|Feedback given on inhaler use by research nurse/ doctor based on mobile application feedback
15988140|NCT02977078|Device|Inhaler casing|Monitors inhaler use
15988141|NCT02977078|Device|Mobile application|Mobile application software linked to inhaler casing
15988142|NCT02977065|Drug|Atorvastatin 20mg|PO daily for 4weeks
15988143|NCT02977065|Drug|Atorvastatin 20 mg + CKD-519 50 mg|PO daily for 4weeks
15988144|NCT02977065|Drug|Atorvastatin 20 mg + CKD-519 100 mg|PO daily for 4weeks
15988145|NCT02977065|Drug|Atorvastatin 20 mg + CKD-519 200 mg|PO daily for 4weeks
15988146|NCT02977065|Drug|Rosuvastatin 10 mg|PO daily for 4weeks
15988147|NCT02977065|Drug|Rosuvastatin 10 mg + CKD-519 100 mg|PO daily for 4weeks
15988148|NCT02977052|Drug|Ipilimumab|
15988149|NCT02977052|Drug|Nivolumab|
15988150|NCT02977052|Procedure|Surgery|Surgery will be done at 6 weeks
15988151|NCT02977052|Procedure|Blood for PBMCs|Blood will be taken for translational research on PBMCs
15988152|NCT02977052|Procedure|Biopsies|Biopsies will be taken during screening and at relapse.
15988153|NCT02977039|Other|NDPR diet|nutrient rich plant based diert
15988154|NCT02977039|Other|USDA healthy eating diet|DASH diet
15988155|NCT02977026|Behavioral|CYD|
15988156|NCT02977026|Behavioral|AHC|
15988157|NCT02977013|Diagnostic Test|Anti-Xa assay|Correlation between anti-Xa assay and the efficacy and safety of enoxaparin in the treatment of pulmonary embolism
15988158|NCT02977000|Drug|Propranolol|Propranolol was administered orally as a dose of 1.5 mg/kg.d divided q8h.investigators used powdered drug, dissolved in 5% dextrose. The treatment was continued until complete development of retinal vascularization, although administration was not permitted for more than 90 days.
15988159|NCT02976987|Drug|Cidofovir|
15988160|NCT02976974|Other|Manual therapy|Application of different manual therapy techniques through posterior and inferior humeral head slides, as well as scapular movements. Also, rotator interval stretching will be done.
15988161|NCT02976974|Other|Therapeutic exercise|"Shoulder extension: Elastic bands.
~Shoulder flexion: Elastic bands
~Shoulder external rotation: Elastic bands.
~Scapulothoracic stability: Movement of scapular adduction guided by the physiotherapist, keeping the position for few seconds ; standing push up on the wall.
~Thoracic column movements: Flexion-extension"
15988162|NCT02976961|Other|Supportive care|Information, guidance, supportive care, and psychological intervention
15988163|NCT02976948|Other|No intervention|
15988164|NCT02976935|Other|hyperpolarised 129 Xenon|Hyperpolarised 129 Xe to assess lung function
15988165|NCT02976922|Dietary Supplement|Probiotic lozenge|10 patients with RAS are randomised to active treatment with probiotic lozenge, one lozenge twice daily for 3 months and other 10 patients with RAS are randomised to treatment with placebo lozenge, one lozenge twice daily for 3 months.
15988166|NCT02976909|Drug|Paclitaxel+Cisplatin+5fluorouracil|Patients will receive the following chemotherapy: Paclitaxel 135mg/m2 IV over 3 hours on Day 1; Cisplatin 75mg/m2 IV over 1 hours on Day 1; 5-FU 4g/m2 for 5 days continuous infusion from Day 1 to Day 5.
15988167|NCT02976896|Drug|Apatinib Mesylate|Patients will receive Apatinib Mesylate at 500mg/times,oral one times daily for 28 days.
15988168|NCT02976883|Other|[18F]HX4 diagnostic PET/CT scan|Single intravenous injection of [18F]HX4 and PET/CT scan
15988169|NCT02976870|Radiation|Ultrasound|Single ultrasound scan of kidney on side of body where ALIF was performed. If hydronephrosis of this kidney is detected, the second kidney will also be scanned.
15988170|NCT02976857|Biological|C-CAR-011|lymphocytes will be transduced with lentiviral vector containing CAR-CD19 gene.
15988171|NCT02976844|Procedure|Positive end-expiratory Pressure|Positive end-expiratory pressure will be used during mechanical ventilation.
15988172|NCT02976831|Drug|AZD0284|Oral solution, concentration: 2 mg/mL and 15 mg/mL
15988173|NCT02976831|Drug|Placebo|Placebo matching AZD0284 in the form of an oral solution with water.
15988174|NCT02976805|Drug|4L PegLyte + 15 mg bisacodyl|Randomized
15988175|NCT02976805|Drug|6L PegLyte + 15 mg bisacodyl|Randomized
15988176|NCT02976792|Procedure|Renal Resistive Index/NephroCheck™test|Renal Resistive Index and NephroCheck™ test before TAVI and after TAVI
15988177|NCT02976779|Drug|OWC MGC cream|Topical cream containing 3% CBD and 3% THC for Psoriasis treatment
15988178|NCT02976779|Drug|OWC Control Cream|Topical Cream without active ingredients
15988181|NCT02976753|Drug|efmoroctocog alfa|extended half-life factor VIII product
15988182|NCT02976753|Drug|Factor VIII|conventional factor VIII product
15988183|NCT02976740|Radiation|SBRT|Stereotactic body radiotherapy A type of radiation therapy to the Metastasis lesion
15988184|NCT02976740|Drug|Immunological Agent|Subcutaneous injection of human recombined granulocyte-macrophage colony stimulating factor (125ug/m² per day) will be executed from day 1 to day 14 in this cycle. Another metastasis lesion will be treated likewise concurrently with rhGM-CSF in a consecutive cycle.
15988185|NCT02976740|Drug|Immunological Factors|Thymosin Alpha 1(1.6mg Biw)will be executed from the fist Week to the 12th Weeks.
15988186|NCT02976727|Drug|Topical Vitamin D (Calcipotriol) application|Calcipotriol ointment 50 mcg/g (Daivonex, Leo Pharma, Denmark) was applied twice for daily on treatment area for 15 consecutive days.
15988187|NCT02976727|Drug|Placebo cream application|placebo cream (indistinguishable from calcipotriol cream by visual and physical appearance and sense of smell) was applied twice for daily on treatment area for 15 consecutive days.
15988188|NCT02976727|Drug|lidocaine/prilocaine (5%) application|For AFL pre-treatment, lidocaine/prilocaine (5%) cream (EMLA; Astra Pharmaceuticals, LP, Westborough, MA, USA) was applied to the treatment area under occlusion for 30 min
15988189|NCT02976727|Device|2940-nm Er:YAG AFL pretreatment|After the anaesthetic cream was removed, AFL therapy was performed using a 2940-nm Er:YAG AFL (Joule; Sciton Inc., Palo Alto, CA, USA) at 300-550 µm ablation depth, level 1 coagulation, 22% treatment density and a single pulse
15988190|NCT02976727|Drug|MAL application|Immediately after AFL treatment, an approximately 1- mm-thick layer of MAL (Metvix, PhotoCure ASA, Oslo, Norway) was applied to the lesion and on 5 mm of surrounding normal tissue. Incubation time is 3 hours
15988191|NCT02976727|Other|Measurements of the fluorescence intensity|After 3 hours of application with MAL, saline wash was performed and fluorescence imaging analysis was performed with ultraviolet examination light (model 31602,356 nm; Burton Medical Products Crop.) at 10 cm height above the base of each lesion. The red fluorescence (610 nm-700 nm) was separated and extracted by ImageJ program and then used to measure the amount of 633 nm fluorescence of protoporphyrin IX.
15988192|NCT02976727|Device|irradiation with red light-emitting diode lamp|After incubation for 3 hours, the dressing and cream were removed, and the area was cleansed with saline. The area was irradiated with a red light-emitting diode lamp (Aktilite CL 128; PhotoCure ASA, Oslo, Norway) with peak emission at 632 nm, placed 5 cm away from the skin surface, and a total light dose of 37 J/cm-2. All patients wore protective goggles during illumination.
15988194|NCT02976701|Drug|DLBS1033|
15988195|NCT02976701|Drug|Placebo|
15988196|NCT02976701|Drug|Standard therapy|Standard therapy which consists of: aspirin enteric-coated tablet 1 x 80 mg and clopidogrel film-coated tablet 1 x 75 mg daily for four weeks will be given to both arms.
15988197|NCT02976688|Other|Sodium Propionate|Sodium propionate is a non-toxic food additive, confirmed and licensed by the European Food Safety Authority (EFSA) sodium propionate E281. We are planning the oral application of 500 mg SP 2x per day. This dose is about 0.014 mg/kg of the body weight. Therefore, no risk of toxicity is expected in the patients.
15988198|NCT02976675|Biological|PEG-somatropin|Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/bottle Group of dosing per week:0.20 mg /kg/w, once per week for 26 weeks
15988199|NCT02976675|Biological|PEG-somatropin|Pegylated somatropin, injection, 54IU/9.0mg/1.0ml/bottle Group of dosing per two weeks:0.20 mg /kg/2w，once per two weeks for 26 weeks
15988200|NCT02976662|Procedure|Artificial shrinkage|Artificially eliminated blastocoelic fluid before vitrification procedures.
15988201|NCT02976636|Behavioral|Family-based behavioral therapy|Traditional family-based, group-based behavioral therapy for weight loss. Parent and child groups will be held separately. Intervention will consist of 20 sessions: 16 weekly sessions, and then every other week for 4 sessions.
15988202|NCT02976636|Behavioral|Parenting training|Parenting skills training for parents. Parent and child groups will be held separately and only parents will receive this training. Children will not receive any additional materials. Intervention will consist of 20 sessions: 16 weekly sessions, and then every other week for 4 sessions.
15988203|NCT02976623|Other|metric-based feedback training|Structured feedback; a trained investigator will give feedback according to a set of metrics and errors previously developed and validated. Trainees will undergo deliberate practice on the volunteer until they demonstrate adequate and objective performance as assessed by the set of metrics and errors provided.
15988204|NCT02976610|Device|Hemolysis Point-of-Care test|Hemolysis measurement of plasma using a point of care test to determine the hemolysis level in plasma
15988205|NCT02976597|Drug|Bupivacaine 0.25% 20ml on each side Sonar guided TAB|Bupivacaine 0.25% 20ml on each side Sonar guided TAP block. After careful aspiration injection of 20ml of 0.25% bupivacaine will be performed and hypoechoic layer will be detected on ultrasound then the maneuver will be repeated on the other side
15988206|NCT02976597|Drug|Morphine 10mg|Morphine 10mg will be added to bupivacaine in sonar guided- TAP block divided into 5mg on each side.
15988207|NCT02976597|Drug|Morphine 15mg|Morphine 15mg will be added to bupivacaine in sonar guided- TAP block divided into 7.5mg on each side.
15988208|NCT02976571|Drug|Bupivacaine|Sub cutaneous and/or Intraperitoneal Marcaine application
15988209|NCT02976558|Behavioral|Clown theatrical Performance|
15988210|NCT02976558|Procedure|Acupuncture|Acupuncture according to Traditional Chinese Medicine
15988211|NCT02976558|Behavioral|Music Therapy TaKeTiNa|
15988212|NCT02976545|Device|fMRI (functional Magnetic Resonance Imaging)|fMRI examination
15988213|NCT02976545|Behavioral|psychiatric evaluation|psychiatric evaluation
15988214|NCT02976532|Other|Electromagnetic tracking unit in femoral derotation surgery|Use of the electromagnetic tracking system during the surgical procedure in addition to the normal measurement with goniometer, the different devices listed are combined to form the EMT system unit
15988215|NCT02976519|Drug|BI 443651|twice daily
15988217|NCT02976506|Behavioral|Unsupervised exercise program|Both control and intervention group undergo clinical evaluation, and anthropometric measurements, blood pressure (casual and ambulatory blood pressure monitoring), physical and laboratorial tests, and the assesment of Quality of Life by Questionnaire SF-36 were done at the beginning and the end of the study.After a period of 12 weeks of unsupervised walking program in which participants were asked to do it three times a week at least, at a moderate intensity (40 to < 60% of heart rate reserve), all participants underwent a complete re-evaluation to compare the results obtained with the proposed program. Data were analyzed using SPPS, v.23.0.
15988218|NCT02976506|Behavioral|Physical fitness and quality of life|Both control and intervention group undergo clinical evaluation, and anthropometric measurements, blood pressure (casual and ambulatory blood pressure monitoring), physical and laboratorial tests, and the assesment of Quality of Life by Questionnaire SF-36 were done at the beginning and the end of the study.After a period of 12 weeks of unsupervised walking program in which participants were asked to do it three times a week at least, at a moderate intensity (40 to < 60% of heart rate reserve), all participants underwent a complete re-evaluation to compare the results obtained with the proposed program. Data were analyzed using SPPS, v.23.0.
15988219|NCT02976493|Other|No Intervention|No Intervention
15988220|NCT02976480|Procedure|Irrigation|A designated unblinded medical team member (nurse, emergency room physician or resident/trainee uninvolved in that particular patient's care) will prepare the laceration for repair and perform the irrigation. Irrigation will be delivered through a 20 Gauge 1 inch long catheter mounted on a 60 millilitre syringe. The volume of normal saline used will be calculated as 60 millilitre per centimetre length of laceration for a maximum of 300 millilitre. Once completed, the treating physician will enter the room and proceed to the laceration closure with the method and equipment of his choice. Both the patient (through eye covering) and the treating physician will remain blinded to the intervention.
15988221|NCT02976480|Procedure|No irrigation|A designated unblinded medical team member (nurse, emergency room physician or resident/trainee uninvolved in that particular patient's care) will prepare the laceration for repair. The laceration will not directly be irrigated. In order to ensure blinding of the subjects, the surrounding of the wound will be irrigated with a total of 60 millilitre of normal saline delivered through a 20 Gauge 1 inch long catheter mounted on a 60 millilitre syringe. Care will be taken not to enter a margin of 5cm from the laceration edges. Once completed, the treating physician will enter the room and proceed to the laceration closure with the method and equipment of his choice. Both the patient (through eye covering) and the treating physician will remain blinded to the intervention.
15988222|NCT02976467|Drug|Fulacimstat (BAY1142524)|25 mg BAY 1142524 are given twice daily over a treatment period of 6 months
15988223|NCT02976467|Drug|Placebo|Matching placebo tablets are given twice daily over a treatment period of 6 months
15988224|NCT02976454|Behavioral|Guided Self-Help Obesity Treatment|Guided Self-Help obesity treatment will be provided by a health coach in the clinic. The treatment involves 14 sessions: 1 one-hour session and 13 twenty-minute sessions with the health coach who will provide behavioral obesity treatment.
15988225|NCT02976454|Behavioral|Family-based behavioral obesity treatment|Traditional family-based, group-based behavioral weight control program. The treatment involves 20 hourly group-based sessions for parents and children separately, which occurs weekly for 16 weeks, then every other week for the last 2 months (4 session).
15988226|NCT02976441|Radiation|Radiation therapy|
15988227|NCT02976441|Drug|Temozolomide|
15988228|NCT02976441|Procedure|Stem cell collection|
15988229|NCT02976441|Procedure|Stem cell infusion|
15988230|NCT02976428|Procedure|Sensor Guided Soft Tissue Balancing|Primary TKR with soft tissue balancing with a sensor guided device.
15988231|NCT02976428|Procedure|Standard Soft Tissue Balancing|Primary TKR with soft tissue balancing with a standard of care manual tensiometer device.
15988232|NCT02976415|Other|In-Bed Cycling|20 minutes of in-bed cycling, either active, passive or a combination of active and passive.
15988233|NCT02976402|Radiation|SBRT|"Postoperative RT consisting in:
~31 Gy in 5 sessions each of 6.2 Gy (adjuvant intent) delivered in one week
~32.5 Gy in 5 sessions each of 6.5 Gy (salvage intent) delivered in one week"
15988234|NCT02976389|Other|Financial Incentive: High|dlParticipants in this group will receive an additional $40/month to use towards the purchase of SNAP eligible fruits and vegetables. They will be able to access these dollars through an electronic wallet (e-wallet) that is tied to their customer loyalty card. They will also have access to the fruit and vegetable promotions that include discount pricing and SNAP-Ed programming (e.g., in-store cooking classes, tours, and healthy food self-labeling system) to educate and support the purchasing behaviors of SNAP-eligible families.
15988235|NCT02976389|Other|Financial Incentive: Middle|Participants in this group will receive an additional $20/month to use towards the purchase of SNAP eligible fruits and vegetables. They will be able to access these dollars through an electronic wallet (e-wallet) that is tied to their customer loyalty card. They will also have access to the fruit and vegetable promotions that include discount pricing and SNAP-Ed programming (e.g., in-store cooking classes, tours, and healthy food self-labeling system) to educate and support the purchasing behaviors of SNAP-eligible families.
15988236|NCT02976389|Other|Financial Incentive: Low|Participants in this group will receive an additional $10/month to use towards the purchase of SNAP eligible fruits and vegetables. They will be able to access these dollars through an electronic wallet (e-wallet) that is tied to their customer loyalty card. They will also have access to the fruit and vegetable promotions that include discount pricing and SNAP-Ed programming (e.g., in-store cooking classes, tours, and healthy food self-labeling system) to educate and support the purchasing behaviors of SNAP-eligible families.
15988237|NCT02976376|Other|The Box|The Box contains four smartphone compatible devices. Patients will measure their vital signs and automatically send them to the hospital.
15988238|NCT02976363|Radiation|Radiotherapy breast cancer|
15988239|NCT02976363|Other|Evaluation Maximal Respiratory Pressures|
15988240|NCT02976337|Drug|Naloxone|active drug infusion
15988241|NCT02976337|Drug|Normal Saline|placebo comparator
15988242|NCT02976324|Device|external diaphragmatic pacemaker group|9 counts per minute, with stimulate frequency 40 Hz
15988243|NCT02976311|Procedure|cesarean section(C/S) via the modified Misgav-Ladach technique|the first consecutive 44 patients underwent C/S via the modified Misgav-Ladach technique
15988350|NCT02975453|Drug|Rivaroxaban (Xarelto, BAY59-7939)|As prescribed by the treating physician
15988244|NCT02976311|Procedure|cesarean section via the Pfannenstiel-Kerr technique|the second consecutive 44 patients underwent C/S via the Pfannenstiel-Kerr technique
15988245|NCT02976298|Other|transcranial magnetic stimulation|comparison of different conditions of transcranial magnetic stimulation
15988246|NCT02976285|Procedure|arthroscopic rotator cuff repair with a polyester patch|Patients were operated under general anesthesia and a supraclavicular nerve block, in a beach-chair position with 80° forward shoulder flexion and traction between 3-5 kg. After washing and draping a standard viewing portal was placed at the dorsal softspot. Further portals included, a lateral, a dorso-lateral, an antero-lateral and an anterior portal. If additional pathologies were present, they were treated simultaneously and mostly involved the long head of the biceps tendon, treated with tenodesis or tenotomy respectively. After a thorough bursectomy, the rupture was fully visualized and thereafter its size was estimated. Following debridement of the footprint, we used a triple row repair and implanted the patch.
15988247|NCT02976272|Other|bortezomib|
15988248|NCT02976259|Drug|Dolutegravir|All patients included must have treated by dolutegravir. They will have some exams (plasma samples, sperm samples)
15988249|NCT02976246|Dietary Supplement|Vitamin K2 (MK7)|One tablet of vitamin K2 (MK7) 360 micrograms given once daily.
15988250|NCT02976246|Other|Placebo|One tablet of placebo given once daily.
15988251|NCT02976220|Other|Digital Education|Online videos, illustrations, and text materials designed to improve participants' awareness and understanding of kidney function, kidney disease, kidney failure options, peritoneal dialysis, home hemodialysis, in-center hemodialysis, kidney transplant, medical management, and treatment decision. Also includes online messaging system and discussion board designed to allow participants to message study nurse and peer mentor, as well as to engage in group discussion in an open forum and about specific scenarios.
15988252|NCT02976194|Drug|ranibizumab|Ranibizumab 0.5mg is injected into the vitreous cavity through the pars plana using 30 gauge (or narrower) needle-attached syringe.
15988253|NCT02976181|Device|IPG|Patient might require IPG device to be implanted under standard of care
15988254|NCT02976168|Other|12° head down tilt|supine head down tilt
15988255|NCT02976155|Other|A standard enteral nutrition protocol|Patients in the experimental arm, the practice of enteral nutrition will based on a standard protocol. The core content of this protocol includes five step：1. Whether the participants need nutrition therapy? 2. The choice of nutrition way? 3. Nasogastric tube or nasointestinal tube? 4. The choice of enteral nutrition type? 5. The target calorie and protein of the participants? And how to achieve these target？(In this study, the practice of the above protocol is the only intervention).
15988256|NCT02976142|Procedure|neoadjuvant chemoimmunotherapy|
15988257|NCT02976129|Drug|V565|Daily dosing of V565 three times a day orally for 6 weeks
15988258|NCT02976129|Drug|Placebo|Daily dosing of placebo three times a day orally for 6 weeks
15988259|NCT02976116|Drug|Fruquintinib|Fruquintinib will be administered orally once daily from Day 1 to Day 21 per 28-day cycle until disease progression or unacceptable toxicity
15988260|NCT02976116|Drug|Gefitinib|Gefitinib will be administered orally once daily per 28-day cycle or unacceptable toxicity
15988261|NCT02976103|Device|Jacki Recovery jacket|An outer jacket that holds surgical drains and allows access for blood draws
15988262|NCT02976103|Other|Standard Care Pain medicine/management|Standard care pain medicine and management in hospitals where the study enrolls
15988263|NCT02976077|Behavioral|RC2S+|new cognitive remediation program
15988264|NCT02976077|Behavioral|active comparator|cognitive remediation program
15988265|NCT02976064|Behavioral|PreHabilitation|"Case identification: Candidates fulfilling the inclusion criteria will be identified by the anesthesiologist.
~Case evaluation: Candidates will be assessed to identify the overall needs and perform a baseline evaluation.
~Personalized Work plan definition: Personalization of the plan involves a calendar and planning of face to face visits and remote contacts; intensity of the supervised exercise training program; threshold of steps per day; nutritional intervention; psychological intervention; and integration of the intervention into the overall work plan.
~Work plan execution & 5-Follow-up+event handling: Involve the follow-up tasks, including non-scheduled interactions through the personal health folder (PHF)
~6-Discharge: Patient will be discharged from prehabilitation and moved to rehabilitation."
15988266|NCT02976064|Behavioral|Rehabilitation in chronic stable patients in primary care|"Case identification: Candidates fulfilling the inclusion criteria will be identified by the general practitioner.
~Case evaluation: The primary care team will characterize the candidates, covering: i) patient requirements defining the work plan; ii) aerobic capacity and physical activity; iii) identification of factors modulating adherence.
~Personalized work plan definition: The community-based intervention will include reassessment of the patient's work plan aiming at optimization of both pharmacological and non-pharmacological therapies. Consist of a motivational interview and a physical activity (PA) intervention (6-month duration) based on supervised endurance training, promotion of PA and empowerment for self-management using the PHF.
~Work plan execution & 5-Follow-up+event handling: The ICT-support will facilitate the program follow up.
~6-Discharge: The patient will be discharged or moved to the PA service addressed to citizens at risk & patients with mild disease."
15988267|NCT02976064|Behavioral|Rehabilitation in mild chronic patients and citizens at risk|"Case identification: Candidates fulfilling the inclusion criteria will be identified by the GP.
~Case evaluation: i) patient requirements defining the work plan; ii) aerobic capacity and PA; iii) identification of factors modulating adherence.
~Personalized work plan definition: i) motivational interview; ii) training for the use of the PHF for self-management; and iii) assign one case manager for off-line remote surveillance. The following optional modules are envisaged: i) basic service (above); ii) endurance training programs; iii) community physical activity group sessions; and/or, iv) upgraded PA program including sensors and close off-line supervision.
~Work plan execution & 5-Follow-up+event handling: The ICT-support will facilitate the program follow up.
~6-Discharge: The basic version of the promotion of PA program is conceived for a timeless duration. However, the different modules included in the service portfolio will have specific agendas and associated costs."
15988268|NCT02976051|Radiation|HART-CN|HART-CN: Hyperfractionated accelerated radiotherapy with weekly concommitant cis-platin and daily nimorazole
15988269|NCT02976038|Drug|elamipretide|40 mg, subcutaneous injections (in the abdomen) daily for the shortest of the following: 260 weeks; regulatory approval and commercial availability of elamipretide in the subject's respective country; or termination of the clinical development for elamipretide in subjects with PMD.
15988270|NCT02976025|Other|Longitudinal Remote Consultation|Longitudinal Remote Consultation utilizes video conferencing to efficiently link providers to consultants who provide timely feedback and training in collaborative care. LRC will be provided in addition to standard collaborative care training and support.
15988271|NCT02976025|Other|Collaborative Care|Standard collaborative care implementation training and support.
15988272|NCT02976012|Drug|Aflibercept|. Study eyes will receive one preoperative intravitreal aflibercept injection (IAI) <21 days prior to vitrectomy and one intraoperative intravitreal aflibercept at end of surgery. Eyes will be randomized on the day of surgery or 1-2 weeks post-operatively to either a q8week IAI dosing regimen group or a q16week IAI dosing regimen group.
15988273|NCT02976012|Procedure|Endolaserless Vitrectomy|Endolaserless vitrectomy and intraoperative and postoperative IAI in patients with PDR-related vitreous hemorrhage
15988274|NCT02975999|Drug|Vasopressin|Vasopressin at dose of 0.4mU/kg/min will be started on the assigned group once coming off cardiopulmonary bypass following the Fontan operation.
15988275|NCT02975999|Drug|Normal Saline|Normal saline at starting dose of 0.4mU/kg/min will be started on the assigned group once coming off cardiopulmonary bypass following the Fontan operation.
15988276|NCT02975986|Other|123I-BMIPP|Uptake of radioactive isotope by the kidney
15988277|NCT02975986|Other|99mTc-MAG3|Uptake of radioactive isotope by the kidney
15988278|NCT02975973|Device|transcranial direct current stimulation|transcranial direct current stimulation (tDCS) is a safe, noninvasive, weak electrical current delivery that stimulates brain function. It is a novel therapeutic for cognition in schizophrenia.
15988279|NCT02975960|Biological|injection of autologous stromal vascular fraction|"Acquiring autologous stromal vascular fraction (SVF) from liposuction
~purifying SVF from lipoaspirates and making syringe filled with SVF
~SVF injection - Inject SVF on fingers subcutaneously."
15988280|NCT02975947|Device|Humidified, warmed CO2 insufflation of open peritoneum using Fisher & Paykel's HUMIGARD (Fisher & Paykel Healthcare Ltd, Auckland, New Zealand)|The study group will receive warmed (37°C), humidified (98% RH) carbon dioxide into the open peritoneal cavity using the Fisher & Paykel's HUMIGARD system (Fisher & Paykel Healthcare Ltd, Auckland, New Zealand). This will create a local atmosphere of 100% carbon dioxide (warmed, humidified) in the open peritoneal cavity.
15988281|NCT02975947|Device|Standard heating|Standard intraoperative warming measures including heated blankets, heating with forced warmed air, warming of fluids, and insulation of limbs and head
15988282|NCT02975934|Drug|Rucaparib|Rucaparib will be administered daily.
15988283|NCT02975934|Drug|Abiraterone acetate or Enzalutamide or Docetaxel|Abiraterone acetate and enzalutamide will be administered daily. Docetaxel will be administered every 3 weeks.
15988284|NCT02975921|Drug|Povidone-Iodine|Intrapleural administration of Povidone-Iodine
15988285|NCT02975895|Device|Hydrophobic IOL: Vivinex (HOYA)|Patients requiring cataract surgery will be randomized to one of the two types of IOLs.
15988286|NCT02975895|Device|Hydrophilic IOL: INCISE (Bausch+Lomb)|Patients requiring cataract surgery will be randomized to one of the two types of IOLs.
15988287|NCT02975882|Drug|Irinotecan Hydrochloride|Given PO
15988288|NCT02975882|Other|Laboratory Biomarker Analysis|Correlative studies
15988289|NCT02975882|Drug|Nanoparticle Albumin-Bound Rapamycin|Given IV
15988290|NCT02975882|Other|Pharmacological Study|Correlative studies
15988291|NCT02975882|Drug|Temozolomide|Given PO
15988292|NCT02975869|Other|Standard Leukemia Care|
15988293|NCT02975869|Other|Palliative Care|
15988294|NCT02975856|Dietary Supplement|Table Red Wine|
15988295|NCT02975856|Dietary Supplement|Young Port Red Wine|
15988296|NCT02975843|Drug|Beclometasone dipropionate/Formoterol Fumarate/Glycopyrronium|single inhalation of 99mTc radiolabelled CHF 5993 pMDI (4 puffs for a total dose of: Beclometasone diproprionate (BDP) 400 μg, Formoterol fumarate (FF) 24 μg, Glycopirronium bromide (GB) 50 μg)
15988297|NCT02975830|Radiation|Three dimensional CT based images|Right bronchial angle, left bronchial angle
15988298|NCT02975817|Other|Hibler's|Passive body heat retention using multiple-layer tight wrapping of patient
15988299|NCT02975817|Other|Warm Air|Active, convective warming of patient using warm air blanket
15988300|NCT02975804|Device|Tymo|All children will be calibrated using the Tymo in a static sitting position in each treatment session. The amplitude of the force and weight distribution generated by the child between the two sides of the body will be recorded. This information will be used to set up the Tymo as a training module (the intervention) by the software, in which the child will move the trunk forward, backward and sideways to participate in a computer game in sitting. The child will choose which game they want in each treatment session and they have to stay on the same game for at least 10 minutes before changing to another game.
15988301|NCT02975791|Other|Marking the cricothyroid membrane after ultrasound|Ultrasonography is applied to the subjects neck in order to identify the cricothyroid membrane - subsequently the membrane is marked with a pen
15988302|NCT02975791|Procedure|Marking of the cricothyroid membrane after Palpation|Palpation is applied to the subjects neck in order to identify the cricothyroid membrane- subsequently the membrane is marked with a pen
15988303|NCT02975778|Device|Pain Monitor™|Pain measured by Pain Monitor™
15988304|NCT02975765|Procedure|Piezosurgery|The surgical tip is going to be used to make small cuts into the cortex of the alveolar bone between the crowded teeth.
15988305|NCT02975752|Genetic|LC-RT-PCR and NGS|highly sensitive PCR vs. multiplex targeted-resequencing
15988306|NCT02975739|Device|Holmium-166 (poly L lactic acid) microspheres|Intratumoral injections of Holmium-166 (poly L lactic acid) microspheres
15988307|NCT02975726|Device|Peritoneal Dialysis Catheter|Peritoneal dialysis catheter insertion in order to drain access fluid within the belly for patients with liver cirrhosis and refractory ascites.
15988308|NCT02975726|Procedure|Large Volume Paracentesis|Insertion of a needle into the peritoneal cavity where ascites accumulates, then attaching the needle to a collection system that drains the ascites by gravity. This procedure is part of the standard care for the treatment of refractory ascites.
15988309|NCT02975726|Biological|25% Human Serum Albumin injection|Patients will be given Human Serum Albumin after the initial drain of ascites fluid: 100cc for 5-10L drainage, 200cc for 10-15L drainage.
15988310|NCT02975726|Procedure|Bloodwork|Monthly bloodwork will be done as part of usual standard of care.
15988311|NCT02975700|Drug|PLX3397|
15988312|NCT02975687|Biological|CD19 CAR T cells|CD19 CAR T cells was transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:4-1BB.
15988313|NCT02975674|Device|MT-12 dental implant|Placement of the MT-12 dental implant with Morse taper implant-abutment connection
15988314|NCT02975674|Device|CON.INT dental implant|Placement of the CON.INT dental implant with internal hexagon implant-abutment connection
15988315|NCT02975648|Behavioral|educational model + follow up|Orientation from health professionals at discharge, educational program with explanation of booklets and telephone follow-up (three calls)
15988316|NCT02975648|Behavioral|usual care|Hospital health professionals offered orientation on care after discharge
15988317|NCT02975635|Other|Questionnaire|Patients are given a questionnaire with items related to personality and behaviour.
15988318|NCT02975622|Procedure|Central venous catheterization|Ultrasound guided central venous catheterization
15988319|NCT02975609|Radiation|Conventional Fractionated Radiotherapy|5Fx/W,3Gy/Fx,Dt:PTV-G:30Gy/10F/2W for metastatic sites, Dt:60Gy/30F for primary tumor and metastatic lymph node.
15988320|NCT02975609|Radiation|Stereotactic Body Radiation Therapy|30Gy/3-5F for the primary and the metastases.
15988321|NCT02975596|Other|Awareness|Awareness: Conduct an awareness campaign throughout Alachua County to alert the community in general to the significance of Serogroup B meningococcal disease in the United States. To inform the material included in the awareness campaign and the education materials, semi-structured interviews with members for each of the key stakeholder groups: students, parents, and medical practitioners will be conducted.
15988322|NCT02975596|Other|Education|Education: This component will be both web-based and in-person to meet the individual needs of the learners. There will be parent and a student (18-23 years old) version of the educational curriculum. National resources of patient -focused materials and guidelines will be adapted. There will be pre- and post-education surveys to assess knowledge and vaccine decision-making.
15988323|NCT02975596|Other|Empowerment|"Empowerment: A guided program for adolescents and young adults on Decision-Making for your Health will be offered on the vaccination days to assist youth in assessing and utilizing health information to guide their personal decision-making for vaccines."
15988324|NCT02975596|Other|Accessibility|Accessibility: MenB vaccine will be offer on the high school and university campuses through a collaborative program between the local schools, university and department of health. We will offer students booster shots of Men ACWY and HPV at the same time. All vaccines will be offered free of charge. Each vaccine administered will be recorded in Florida SHOTS.
15988325|NCT02975583|Drug|Vorapaxar|2.08 mg oral tablet daily
15988326|NCT02975583|Drug|Placebos|Placebo oral tablet daily
15988327|NCT02975570|Drug|Delamanid|Delamanid is a medication used to treat tuberculosis. Specifically it is used, along with other antituberculosis medications, for active multidrug-resistant tuberculosis. It is taken by mouth.
15988328|NCT02975570|Drug|Linezolid|Linezolid is an antibiotic used for the treatment of infections caused by Gram-positive bacteria that are resistant to other antibiotics.
15988329|NCT02975570|Drug|Levofloxacin|Levoflaxacin is an antibiotic used to treat a number of bacterial infections including acute bacterial sinusitis, pneumonia, urinary tract infections, chronic prostatitis, and some types of gastroenteritis. Along with other antibiotics it may be used to treat tuberculosis.
15988330|NCT02975570|Drug|Pyrazinamide|Pyrazinamide is a medication used in combination with other drugs such as isoniazid and rifampicin in the treatment of Mycobacterium tuberculosis.
15988331|NCT02975570|Drug|WHO MDR-TB regimen|The WHO guidelines recommend the following 5-agent treatment regimen for MDR-TB: pyrazinamide; a fluoroquinolone; a parenteral agent (typically amikacin or kanamycin); ethionamide (or prothionamide); and either cycloserine or para-aminosalicylic acid, with preference for cycloserine. Short (9 mos) or longer (20-24 mos) treatment schedules can be used.
15988332|NCT02975557|Drug|Brimonidine 0.15%|Brimonidine 0.15% eye drops 2 times a day for 12 weeks
15988333|NCT02975557|Drug|Brimonidine 0.075%|Brimonidine 0.075% (1:1 dilution will be performed using 0.15% Alphagan-P solution with Refresh Plus Artificial Tears solution) eye drops 2 times a day for 12 weeks.
15988334|NCT02975557|Drug|Placebo|Placebo (Refresh plus Artificial Tear) dispensed in Brimonidine bottles 2 times a day for 12 weeks.
15988335|NCT02975544|Behavioral|CRECES programme|The first unit of CRECES programme was implemented in 8 sessions. Each session was 40-50 minutes long and delivered during four weeks. Parents were provided with home-extension activities.
15988336|NCT02975531|Other|Simulator's construction|Model to build the mold for the simulator
15988337|NCT02975531|Other|Model Features|Volunteers to determine the elasticity of the skin and cirtometry neck to compare with the simulator.
15988338|NCT02975531|Other|Parameterization technique|Evaluation of the simulator features and parameterization of the Pompage technique in the simulator.
15988339|NCT02975531|Other|Simulator training|Training of pompage technique using the simulator.
15988340|NCT02975531|Other|Training Evaluation|Evaluation of volunteers from GE group before and after training with the simulator.
15988341|NCT02975518|Biological|Administration of radio labelled endothelial outgrowth cells|Radio labelled endothelial outgrowth cells will be administered to patients undergoing elective coronary angiography and stenting. They will be administered intra-venously and intra-arterially (right radial artery) in separate arms. Migratory behaviour of these cells will be defined using PET CT. Intra-venous and intra-arterial injection of free radio tracer will serve as a control comparator arms.
15988342|NCT02975505|Other|Strict blood pressure control|Systolic Blood Pressure Target < 120 mm Hg (measured at home)
15988343|NCT02975492|Drug|Cholecalciferol sequential dose|sequential dose administration of the treatment
15988344|NCT02975492|Drug|Cholecalciferol daily dose|daily dose administration of the treatment
15988345|NCT02975479|Drug|ALK Diluent|
15988346|NCT02975479|Drug|ALK Alutard SQ 5-grasses or ALK Alutard Birch|Depot formulation of relevant allergen adsorbed to aluminium hydroxide in a suspension.
15988347|NCT02975466|Device|Insertion of AirQ Blocker and intubation through the device|Insertion of the SGA device and evaluation of easiness of endotracheal intubation
15988348|NCT02975466|Device|Insertion of AuraGain and intubation through the device|Insertion of the SGA device and evaluation of easiness of endotracheal intubation
15988349|NCT02975466|Device|Insertion of I-Gel and intubation through the device|Insertion of the SGA device and evaluation of easiness of endotracheal intubation
15988351|NCT02975440|Drug|Rifampicin|11 single oral doses of 600 mg Rifampicin resulting in a total dose of 6600 mg Rifampicin.
15988352|NCT02975440|Drug|Midazolam|2 single oral doses of 1 mg Midazolam resulting in a total dose of 2 mg Midazolam
15988353|NCT02975440|Drug|BAY1002670_Vilaprisan|2 single oral doses of 4 mg Vilaprisan resulting in a total dose of 8 mg Vilaprisan
15988354|NCT02975427|Other|Diet group|All participants were prescribed an appropriate diet with caloric restriction and an exercise program and underwent a follow-up examination 3±1 months later.
15988355|NCT02975414|Procedure|rTARUP technique|obot-assisted rTARUP technique
15988356|NCT02975401|Procedure|rTAPP technique|robot-assisted rTAPP technique
15988357|NCT02975388|Drug|RO7079901|Participants will receive a single dose of 1000 milligrams (mg) RO7079901 as a 30-minute intravenous (IV) infusion.
15988358|NCT02975375|Procedure|Preoperative geriatric consult or assessment|A preoperative geriatric consult or assessment will be considered to be present if such a consult or assessment is billed by a geriatrician for a patient in the cohort within 4 months preceding surgery. For the primary analysis we will collapse both geriatric consultations and comprehensive geriatric assessments into a single exposure level.
15988359|NCT02975375|Procedure|No Preoperative geriatric consult or assessment|No assessment or consult billed in the 4 months before surgery
15988360|NCT02975362|Other|Acupuncture Treatment|Acupuncture Treatment Acupoint selection base on disease stage combined adjunct acupuncture acupoint base on syndrome differentiation.①Base on disease stage: Flaccid paralysis period: DU24, DU20, Motor Area , LI15, LI14, LI11, SJ5, LI4, GB31, EX-LE2, GB34, ST36, ST40.Spastic period: DU24, DU20, Motor Area , SJ10, SJ13, LI10, SJ8, SJ5, SJ4, SJ4, BL37, BL40, BL39, BL55, BL57, ST41, GB40, BL60.②Base on syndrome differentiation:Excess syndrome of yang-type: LR3, ST37; Deficiency syndrome of Yang-type: KI3, BL23; Excess syndrome of yin-type: SP9, GB20;Deficiency syndrome of Yin-type: CV6, BL23.③Electroacupuncture acupoint: Flaccid paralysis period: LI15, LI4, GB31, ST40; Spastic period: SJ13, SJ5, BL40, BL57.30minutes each time,twenty times / treatment course，two treatment courses in total.
15988361|NCT02975362|Other|Rehabilitation Treatment|Rehabilitation treatment The rehabilitation program was designed according to the Chinese stroke rehabilitation treatment guidelines, which included physical therapy (PT) and occupational therapy (OT). The rehabilitation programs will be carried out five times a week (that is, Monday to Friday) for 8 weeks, and every time the rehabilitation treatment( PT and OT) will last approximately for 1 hour. All rehabilitation treatment will be carried out by qualified therapists
15988362|NCT02975349|Drug|Evobrutinib|Participants received Evobrutinib 75 milligrams (mg) orally, twice daily (BID) up to Week 48
15988363|NCT02975349|Drug|Evobrutinib|Participants received Evobrutinib 25 mg orally, once daily (QD) up to Week 48
15988364|NCT02975349|Drug|Evobrutinib|Participants received Evobrutinib 75 mg orally, QD up to Week 48
15988365|NCT02975349|Drug|Placebo|Placebo were administered for 24 weeks
15988366|NCT02975349|Drug|Tecfidera|Tecfidera; 120 mg hard capsule BID for 7 days then 240 mg hard capsule BID for duration of treatment (48 weeks).
15988367|NCT02975349|Drug|Evobrutinib|Following Placebo for 24 weeks, participants received Evobrutinib 25 milligram (mg) orally, once daily (QD) from Week 24 to 48 weeks.
15988368|NCT02975336|Drug|Placebo|Participants received placebo matched to M2951 orally for 52 weeks.
15988369|NCT02975336|Drug|M2951|Participants received 25 milligrams (mg) of M2951 orally once daily (QD) for 52 weeks.
15988370|NCT02975336|Drug|M2951|Participants received 75 mg of M2951 orally QD for 52 weeks.
15988371|NCT02975336|Drug|M2951|Participants received 50 mg of M2951 orally twice daily (BID) for 52 weeks.
15988372|NCT02975336|Drug|M2951|Participants who had received Placebo or M2951 (25 mg QD, 75 mg QD or 50 mg BID) during DBPC period were switched to receive 50 mg M2951 orally BID in LTE period for 104 weeks.
15988373|NCT02975323|Drug|Carvedilol|Single dose of oral carvedilol 12.5 mg and wait till the time there's 20% reduction in hepatic wedge pressure gradient from the baseline.
15988374|NCT02975310|Procedure|Endoscopic polypectomy in clinic (EPIC)|The experimental intervention is endoscopic polypectomy performed in clinic (EPIC) where nasal polyps are removed using a microdebrider under local and topical anesthesia in the outpatient clinic.
15988375|NCT02975310|Procedure|Endoscopic Sinus Surgery (ESS)|The control intervention is endoscopic sinus surgery (ESS), a minimally invasive procedure that is the current standard that involves polypectomy with a microdebrider as well as sinus ostia enlargement of the affected sinuses performed in the operating room under general anesthesia.
15988376|NCT02975310|Other|General Anesthesia|ESS will be performed under general anesthesia in the operating room
15988377|NCT02975310|Other|Local and topical anesthesia|EPIC will be performed under topical and local anesthesia in a clinic setting
15988378|NCT02975297|Drug|Exenatide|Exenatide Injectable Product will be administered at a dose of 2 mg subcutaneously once a week for 6 weeks.
15988379|NCT02975297|Drug|NRT|Nicotine Patch (21mg) / 24 hours.
15988380|NCT02975297|Behavioral|Counseling|Brief individual behavioral smoking cessation counseling.
15988381|NCT02975297|Drug|Placebo|Normal saline.
15988382|NCT02975271|Drug|Serlopitant|
15988383|NCT02975271|Drug|Placebo|Matching placebo
15988384|NCT02975258|Procedure|Blood draw|Blood will be drawn for plasma, serum, and peripheral blood mononuclear cells.
15988385|NCT02975258|Other|Questionnaires|The following questionnaires are administered to participants by study personnel: Gingo Asthma Questionnaire (GAQ) and the Asthma Quality of Life questionnaire (AQL).
15988386|NCT02975258|Procedure|Spirometry|Spirometry is a simple breathing test that measures the amount of air in one's lungs and how well one can move that air by forcefully blowing 3 or more times into a mouthpiece. A series of these maneuvers will be performed under the instruction of a respiratory technician or respiratory therapist.
15988387|NCT02975258|Procedure|Methacholine challenge test|A methacholine challenge is a common test often used to support a diagnosis of asthma. The test consists of inhaling increasing doses of methacholine through a nebulizer to assess how quickly the participant's airways narrow.
15988569|NCT02974114|Drug|Paracetamol and caffeine|Test product containing 500 mg paracetamol and 65 mg caffeine
15988570|NCT02974114|Drug|Paracetamol|Test product containing 500 mg paracetamol
15988571|NCT02974114|Other|Placebo|Placebo to match paracetamol 665mg sustained release tablets
15988572|NCT02974101|Other|registration of AdaptiveStim|
15988388|NCT02975258|Radiation|Quantitative CT scans|There will be a standard chest CT and an abdominal CT. The CT scans capture contiguous volume scans acquired at slice thicknesses of 5.0 mm in the axial plane and reconstructed with 512 x 512 pixel matrices. CT examinations will encompass the entire thorax and the abdomen and will be performed during a breath-hold at end-inspiration. The investigators will measure % of lung tissue below a threshold for emphysema (i.e. -950 Hounsfield units). Measurements have been histologically-verified and give reproducible measurements. The data set is assembled and analyzed with the image data anonymized. If the participant has had a research chest CT scan done recently, only the abdomen CT will be done.
15988389|NCT02975258|Procedure|Urine pregnancy test|All female participants with childbearing potential will be asked to provide a urine sample for pregnancy testing. The result of the pregnancy test must be negative in order for her to be in this research study.
15988390|NCT02975258|Procedure|Adipose biopsy|The doctor will obtain a sample of fat cells from the participant's abdomen. Numbing medicine will be applied. A needle is placed through the skin & into the fat pad under the skin. A blunt-tip hollow cannula is then used to aspirate fat tissue through the incision.
15988391|NCT02975258|Procedure|Exhaled nitric oxide measurement|The investigators will measure concentrations of exhaled nitric oxide by asking the participant to inhale deeply, and then exhale very slowly into a mouthpiece for between 10-15 seconds.
15988392|NCT02975245|Procedure|Semen collection and analysis|Semen sample will be collected prior to the initiation of chemotherapy and one week after the first round of chemotherapy.
15988393|NCT02975232|Behavioral|F&V economic incentive|50% off eligible fresh, frozen and canned fruits and vegetables (up to $10/day)
15988394|NCT02975232|Behavioral|Cooking Matters Store Tour|Participants will be asked to attend one Coking Matters store tour during January or February 2017
15988395|NCT02975219|Drug|Bevacizumab-800CW|4.5mg Bevacizumab-800CW will be administered intravenously three days prior to surgery
15988396|NCT02975206|Drug|Serlopitant High Dose|serlopitant tablets - high dose
15988397|NCT02975206|Drug|Placebo Oral Tablet|placebo tablet
15988398|NCT02975206|Drug|Serlopitant Low Dose|serlopitant tablets - low dose
15988399|NCT02975193|Behavioral|Computer task assessing cognition|Participants will complete a short computer game to assess cognition.
15988400|NCT02975193|Behavioral|Impulsive-Compulsive Disorders in Parkinson's Disease|Standard clinical questionnaire
15988401|NCT02975193|Procedure|Deep Brain Stimulation Surgery|DBS surgery for the implantation of electrodes for the treatment of motor disorders.
15988402|NCT02975180|Device|FES|The MyndMove FES System (MyndTec Inc., Mississauga, ON) is a fully programmable FES device with eight channels. This system allows motor practice of 17 different reaching and grasping protocols. The muscles stimulated may include the anterior, middle and posterior deltoid, biceps and triceps brachii, flexor digitorum superficialis and profundus, extensor digitorum, thenar eminence, lumbricals, and interossei. The sophistication of this system is unique. In contrast, many of the MyndMove stimulation protocols involve activation of small muscles that are used for fine motor control. The second FES device that will be used is the Odstock 2-channel Stimulator (FES Mobility Ltd., Vancouver, BC). While less sophisticated than the MyndMove system, it is smaller and more portable.
15988403|NCT02975180|Behavioral|Conventional|Conventional training involves repetitive practice of upper extremity movements with manual assistance provided by a therapist as needed.
15988404|NCT02975167|Other|Outpatient Cervical Ripening|The experimental arm of the study will be subjects randomized to the outpatient group. Once randomized, subjects will complete a survey assessing their attitudes, fears, anxiety, satisfaction and expected hours of sleep with outpatient induction of labor. Following placement of the Foley catheter, the subjects will be given detailed instructions for which to return to the hospital, as well as provided a 24 hour phone number to call if they have questions. They will be instructed to return to the hospital once the catheter falls out or if 24 hours has passed since its placement. Upon returning to the hospital, subjects will complete another survey assessing their satisfaction with their induction process.
15988405|NCT02975167|Other|Inpatient Cervical Ripening|Once randomized to this group, subjects will complete a survey assessing their attitudes, fears, anxiety, satisfaction and expected hours of sleep with inpatient induction of labor. Following placement of the Foley catheter, the subjects will undergo normal labor monitoring until their Foley catheter either falls out or is removed at 24 hours. At this time subjects will complete another survey assessing their satisfaction with their induction process.
15988406|NCT02975167|Procedure|Foley catheter placement|Subjects randomized to both the inpatient and the outpatient arms will receive this intervention following completion of a survey. A Bard(TM) 16G two-way 5cc silicone-coated latex Foley catheter will be placed by a physician-member of the research team using a sterile metal speculum and ring forceps, or by hand, depending on physician preference. Once placed within the cervical canal, the Foley will be filled with 60cc of saline
15988407|NCT02975167|Behavioral|Pre-Foley Questionnaire|Prior to randomization into inpatient or outpatient arms, all subjects will complete a questionnaire assessing their attitudes, opinions, fears and anxiety regarding induction of labor.
15988408|NCT02975167|Behavioral|Post-Foley Questionnaire|Following removal of the Foley catheter (either by a physician at 24 hours or spontaneously), all subjects will complete the same questionnaire as prior assessing their attitudes, opinions, fears and anxiety regarding their induction of labor.
15988409|NCT02975167|Procedure|Fetal Non-Stress Test|Following placement of the Foley catheter, all subjects, regardless of arm they are randomized to, will undergo a 20-minute NST. The NST will be read by a physician-member of the research team. If the NST is considered to be suspicious based on the physician's evaluation, subjects randomized to the outpatient arm will be moved to the inpatient arm, but evaluated as part of the outpatient arm on an intent-to-treat basis. All subjects randomized to the inpatient arm will be placed on continuous fetal heart rate monitoring, regardless of physician evaluation of the NST.
15988410|NCT02975154|Device|Microcurrent therapy|The microcurrent therapy will be applied with electrodes that are fixed around the knee. The two electrodes of channel A will be placed at the inner and outer side of the knee that is most affected by pain. The two electrodes of channel B will be placed above and below the patella. An apparatus with CE certificate will be used.
15988411|NCT02975141|Drug|Afatinib 30Mg Tab|Study Drug
15988412|NCT02975141|Drug|Afatinib 40Mg Tab|Study Drug
15988413|NCT02975141|Drug|Gemzar|Chemotherapy Backbone
15988414|NCT02975141|Drug|Abraxane|Chemotherapy Backbone
15988415|NCT02975128|Device|BLES system and conventional lumpectomy|Each patient undergoes the same procedure. Under general anaesthesia for the normal surgical procedure, the tumor is first removed using the BLES system under US guidance. Next, the normal surgical procedure is performed, excising the BLES excision cavity and a ≥ 1cm margin of surrounding tissue, also guided by the US appearance after the BLES procedure.
15988416|NCT02975115|Other|RQ-PCR RNA Analysis|Conventional Q-RT-PCR every 3 months
15988417|NCT02975102|Device|CBL-101 Eye Drops|CBL-101 Eye Drops 3 to 6 times per day for 3 months.
15988418|NCT02975102|Device|Vismed® Multi|Vismed® Multi 3 to 6 times per day for 3 months.
15988419|NCT02975089|Dietary Supplement|"multi-nutrient supplement"|"1.3g/d multivitamins & minerals powder
~Leaflet content (same as control)"
15988420|NCT02975089|Dietary Supplement|"multi-nutrient & soy protein supplement"|"1.3g/d multivitamins & minerals powder
~16g/d isolated soy protein powder
~Leaflet content (same as control)"
15988421|NCT02975089|Dietary Supplement|Nutrition education on balanced diet & food supplement|"Nutrition education with a designed plate
~10g/d mixed nuts (cashews, pumpkin seeds, walnuts, macadamia, pine nuts, and almonds)
~25g/d milk powder (skimmed and calcium added)
~Leaflet content (same as control)"
15988422|NCT02975076|Drug|Sanchitongshu|The study drugs were manufactured according to Good Manufacturing Practice (GMP) by the Pharmaceutical Factory of Chengdu Huasun Group Inc. Ltd. and presented in the form capsules. Every Sanchitongshu capsule weighed 200 mg, contained 100 mg of panaxatriol saponin (PTS) and 100 mg inactive excipient (starch). PTS comprised of dried extracts from roots of Radix Notoginseng, and had been standardised with respect to Ginsenoside Rg1 (50%), Ginsenoside Re (6%), Notoginsenoside R1 (11%). The amounts of the active ingredients were determined by analytical RP-HPLC using an acetonitrile-water gradient system as mobile hase. The peaks were detected by UV-DAD.
15988423|NCT02975076|Drug|placebo of Sanchitongshu|The Sanchitongshu placebo capsule contained dark brown muscovado sugar and the same inactive excipient (starch).
15988424|NCT02975076|Drug|Aspirin|
15988425|NCT02975076|Drug|Clopidogrel|
15988426|NCT02975076|Drug|placebo of clopidogrel|
15988427|NCT02975063|Behavioral|A&T IYCF intervention|(1) Interpersonal communication through frontline workers/volunteers to increase mothers' knowledge and practice of optimal infant and young child feeding (IYCF) behaviors. Interpersonal communication will involve multiple contacts with mothers and an array of IYCF messages; (2) Community mobilization activities to raise awareness of the benefits of optimal IYCF practices among opinion leaders and family members, and increase their support to mother for IYCF; (3) Training of facility and community-based health workers on IYCF to improve their ability to support mothers and provide timely information on IYCF; and (4) Mass media communication on IYCF.
15988428|NCT02975050|Other|Location|
15988429|NCT02975037|Drug|Sildenafil|sildenafil 25 mg PO
15988430|NCT02975037|Drug|Erythromycin|erythromycin 250 mg PO
15988431|NCT02975037|Drug|Itraconazole|itraconazole 100 mg PO
15988432|NCT02975024|Device|laser speckle contrast imaging of the oral mucosa|Non-invasive method to measure tissue blood perfusion applied for oral mucosa
15988433|NCT02975024|Device|wound fluid measurement|Wound fluid at the wound margin is collected using filter strip and volumetrically measured by Periotron 8010 instrument.
15988434|NCT02975024|Device|quantitative determination of VEGF|For the quantitative determination of VEGF in the fourth day wound fluid sample the Human VEGF Quantikine ELISA Kit will be used.
15988435|NCT02975011|Drug|Herbal medicine|Herbal medicine will be administered in water-based decoction (120ml) and dried powder (2g) form (Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, Saposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycine max, Atractylodes japonica).
15988436|NCT02975011|Procedure|Chuna manipulation|Chuna is a Korean spinal manipulation that incorporates spinal manipulation techniques for joint mobilization involving high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement. Chuna manipulation will be administered to pelvic, lumbar, thoracic, and cervical vertebrae at the physician's discretion.
15988437|NCT02975011|Procedure|Bee venom pharmacopuncture|Bee venom pharmacopuncture will be administered only after confirming a negative response to hypersensitivity skin test. Diluted bee venom (saline:bee venom ratio, 10,000:1) filtered for allergens will be injected at 4-5 acupoints proximal to the dysfunctional site at the physician's discretion. Each acupuncture point will be injected to a total of 0.5-1 cc using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
15988438|NCT02975011|Procedure|Pharmacopuncture|Pharmacopuncture consisting of select herbal ingredients will be administered at Hyeopcheok (Huatuo Jiaji, EX B2), Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
15988439|NCT02975011|Procedure|Acupuncture|Acupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
15988440|NCT02975011|Procedure|Electroacupuncture|Electroacupuncture treatment will be administered using mainly proximal acupuncture points and Ah-shi points.
15988441|NCT02975011|Procedure|Cupping|Cupping treatment will be administered at 1-2 points using mainly proximal acupuncture points and Ah-shi points.
15988442|NCT02975011|Other|Other intervention(s)|Patients will be allowed any other additional intervention(s) as deemed necessary by the attending physician regardless of type or dose, and patterns of use will be investigated and recorded as an pragmatic clinical study.
15988443|NCT02974998|Behavioral|Young Women's Health CoOp (YWHC)|Participants received HTC and engaged in a two-session gender-focused intervention. The intervention included information addressing the intersection of substance use, sexual risk, and violence through skill building, role-play, and rehearsal. The intervention also encouraged positive goal-seeking to access linkages to health care within the larger social ecological framework of where the young women live.
15988444|NCT02974998|Behavioral|Standard HTC|Participants received the standard HTC available in South Africa for this population.
15988445|NCT02974985|Device|injection of Restylane Lyft and Restylane L|Intervention--Injections of volumizing products to the midface, nasolabial fold, and marionette folds in female patients in two different age groups
15988573|NCT02974088|Device|Neem-based lotion plus louse comb|Neem-based conditioning lotion was applied to washed and towel dried hair followed by systematic combing using a head louse detection and removal comb
15988446|NCT02974959|Device|gammaCore active device|The nVNS therapy will be performed using the gammaCore-R (electroCore LLC, NJ), which is an external hand-held vagal nerve stimulator. The gammaCore-R produces a low voltage electric signal consisting of five 5000 Hz pulses that are repeated at a rate of 25 Hz. It allows for a 120 second stimulation session. The stimulation will occur twice daily, one time in the morning and one time in the evening. This should be done as close to 12 hours apart as possible and should occur twice daily for the entire 12 week study period.
15988447|NCT02974959|Device|gammaCore sham device|The sham device appears identical to the gammaCore but does not provide a frequency of stimulation powerful enough to stimulate either efferent or afferent fibers of the vagus nerve. However, it does supply a low frequency current which will cause a tingling of this skin to improve blinding of the patients.
15988448|NCT02974946|Device|RenalGuard|
15988449|NCT02974933|Drug|Apatinib combined with pemetrexed|For those pretreated non-squamous non-small cell lung cancer, treat with apatinib 500mg Qd, po.combined with pemetrexed continue until disease progression
15988450|NCT02974920|Drug|Rivaroxaban 10 MG|Rivaroxaban 10 mg once daily for 180 days
15988451|NCT02974920|Drug|Aspirin|Aspirin 100 mg once daily for 180 days
15988452|NCT02974907|Drug|RGN-259|A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, four times a day (QID) for 28 days
15988453|NCT02974907|Drug|Placebo|It is composed of the same excipients as RGN-259 but does not contain Tβ4
15988454|NCT02974894|Dietary Supplement|Probiotic (Lactobacillus Plantarum)|
15988455|NCT02974894|Dietary Supplement|Placebo|
15988456|NCT02974881|Device|Transcatheter Mitral Valve Replacement|Minimally invasive transcatheter mitral valve implantation using the HighLife™ TMVR system
15988457|NCT02974868|Drug|PF-06651600|200 mg QD during induction and 50 mg QD during Maintenance
15988458|NCT02974868|Drug|PF-06700841|60 mg QD during induction and 30 mg QD during maintenance
15988459|NCT02974868|Drug|Placebo|Placebo
15988460|NCT02974855|Biological|PF-06741086|PF-06741086 subcutaneous (SC) injection
15988461|NCT02974855|Biological|PF-06741086|PF-06741086 SC injection
15988462|NCT02974855|Biological|PF-06741086|PF-06741086 SC injection
15988463|NCT02974855|Biological|PF-06741086|PF-06741086 SC injection
15988464|NCT02974842|Device|MAKO 7|Hysteroscopic cell sampling
15988465|NCT02974829|Other|follow-up|
15988466|NCT02974816|Device|Glooko's mobile application|Standard of care and Remote monitoring
15988467|NCT02974803|Drug|Dabrafenib|Dabrafenib 150 mg twice a day until progression or unaccepted toxicity.
15988468|NCT02974803|Drug|Trametinib|Trametinib 2 mg once daily until progression or unaccepted toxicity.
15988469|NCT02974790|Procedure|Echocardiography|Two-dimensional imaging echocardiography
15988470|NCT02974777|Drug|DAPT reduction|Reduction of standard dose DAPT due to low platelet reactivity
15988471|NCT02974777|Drug|DAPT on-target|Standard DAPT within the therapeutic window of platelet reactivity
15988472|NCT02974777|Drug|DAPT intensification|Intensification of standard dose DAPT due to high platelet reactivity
15988473|NCT02974764|Other|No intervention/exposures|
15988474|NCT02974751|Procedure|Aquablation|Aquablation is a minimally invasive transurethral surgical procedure using the AQUABEAM system, a personalized image-guided waterject resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue.
15988475|NCT02974738|Drug|Belzutifan|Belzutifan is a highly selective small molecule that inhibits the function of the HIF-2α transcription factor. As a result, hypoxic signaling in cancer cells is impaired, blocking the transcription of several genes involved in oncogenesis
15988481|NCT02974712|Drug|Fentanyl|
15988482|NCT02974712|Drug|Saline|
15988483|NCT02974699|Dietary Supplement|Potato Starch (Bob's Red Mill)|Subjects will be assigned to Potato Starch (active) following assessment of their gut microbiome.
15988484|NCT02974699|Dietary Supplement|Pregelatinized Starch (Resource ThickenUp)|Subjects will be assigned to Pregelatinized Starch (placebo) following assessment of their gut microbiome.
15988485|NCT02974686|Drug|Everolimus|
15988486|NCT02974686|Drug|Mycophenolic Acid|
15988487|NCT02974673|Procedure|Ejaculatory test|Measures of sphincter pressures during ejaculation will be registered using a sensor introduced in the urethra on patient with spinal cord injury.
15988488|NCT02974660|Drug|Protamine sulfate|
15988489|NCT02974660|Drug|0.9% NaCl|
15988490|NCT02974647|Drug|Ruxolitinib|
15988491|NCT02974634|Other|Ostomy self management training|Ostomy Self management Training group in which subject will learn using pouches and equipment, skin care, ostomy complications, nutritional needs, Impact on feelings, clothing changes, social relationships, being prepared for emergencies, Intimacy and sexuality, communication skills, tips for travelling and physical activity recommendations
15988492|NCT02974621|Biological|Bevacizumab|Given IV
15988493|NCT02974621|Drug|Cediranib|Given PO
15988494|NCT02974621|Drug|Cediranib Maleate|Given PO
15988495|NCT02974621|Drug|Olaparib|Given PO
15988496|NCT02974582|Behavioral|Exposure to smoking advertising with coupon|Direct mail marketing of smoking advertising with discount coupon
15988497|NCT02974582|Behavioral|Exposure to smoking advertising without coupons|Direct mail marketing of smoking advertising without discount coupon
15988498|NCT02974582|Behavioral|Exposure to non health related images|Control group
15988574|NCT02974088|Device|Neem-based lotion plus grooming comb|Neem-based conditioning lotion was applied to washed and towel dried hair followed by combing through using a regular grooming comb
15988575|NCT02974075|Procedure|Salvage lymph node dissection|Open pelvic surgery to dissect pelvic lymph nodes. The landmarks for dissection are: 1. Inferior mesenteric artery 2. Ilioinguinal nerve 3. Inguinal ligament 4. Dorsal pelvic floor 5. Urinary bladder
15988499|NCT02974569|Device|Computer Symptom Capture Tool|"C-SCAT is an investigator developed app that is delivered via an iPad. The original CSCAT included the 30 symptoms from the Memorial Symptom Assessment Scale. The recently updated version includes two additional symptoms feeling bloated and sexual dysfunction that are included in the adult version of the MSAS.21 These symptoms were added based on feedback from the initial AYA sample of 13-29 year olds and in consideration of the developmental perspectives of the AYA population.The CSCAT allows the user to create an image of his or her symptom experience."
15988500|NCT02974556|Procedure|Standard surgical treatment|Standard surgical treatment (open or laparoscopic techniques) containing at least 12 lymph-nodes for accurate pN staging.
15988501|NCT02974556|Procedure|Proactive management|Colon cancer patients (high-risk T3 and T4) without peritoneal or systemic metastases are resected for cure. Simultaneously patients will undergo infracolic omentectomy, appendectomy, exeresis of the liver round ligament and, in women, a bilateral oophorectomy. After positioning three in- and outflow catheters HIPEC perfusion starts with a minimum of 2 L isotonic dialysis fluid at a flow-rate of 1-2 l min and an inflow temperature of 42-43° C with a total of 30 minutes perfusion time. Before the beginning of HIPEC 5-fluouracil and leucovorin will be administrated intravenously to potentiate oxaliplatin activity.
15988502|NCT02974556|Drug|Standard adjuvant systemic chemotherapy|Adjuvant systemic chemotherapy (according CAPOX or FOLFOX regimens for a total of 6 months) will be reserved in patients with pT3 tumors with poor prognostic factors, in patients with pT4 tumors and when lymph-nodes metastases are present. Presence or absence of peritoneal recurrence will be evaluated by MDCT every six months for the first 24 months and later every year for the next three years in both study arms.
15988503|NCT02974543|Device|Sham Treatment: unimodal auditory stimulation|All subjects will be told they will receive either Sham or Active Treatment, but will not know which treatment is assigned. Set up for the sham treatment is the same as the active treatment.
15988504|NCT02974543|Device|Active Treatment: Bimodal auditory-somatosensory stimulation|"Somatosensory stimulation will be delivered by pads positioned on the cheek overlying the trigeminal ganglion, the juncture of the temporomandibular joint or on the neck at overlying cervical nerves, c1 or c2, determined by the manner in which the subject can modulate the tinnitus.
~The auditory stimulus will be individualized based on subject baseline audiogram and tinnitus test results and is presented through a calibrated earphone."
15988505|NCT02974530|Other|Neurological evaluation|
15988506|NCT02974530|Other|Laryngological evaluation|
15988507|NCT02974530|Other|MRI evaluation|
15988508|NCT02974530|Other|Breathing investigation|
15988509|NCT02974530|Other|MRI and articulatory investigation|
15988510|NCT02974530|Other|Postural investigation|
15988511|NCT02974530|Other|Voice and soundscape investigation|
15988512|NCT02974517|Device|EmbryoScope®|The intervention is EmbryoScope® versus conventional incubators.
15988513|NCT02974504|Drug|evogliptin|evogliptin 5mg tablet qd + placebo tablet matching to linagliptin 5mg
15988514|NCT02974504|Drug|Linagliptin|linagliptin 5 mg tablet qd + placebo tablet matching to evogliptin 5mg
15988515|NCT02974491|Other|Fuji apple juice|On two different days, each volunteer consumed 300 mL Fuji apple juice (AJ), immediately after a dialysis section. After a washout period of 3 weeks, the volunteers drank 150 mL Fuji AJ in a similar manner as described above. Before and after 30 and 60 min of AJ consumption, blood samples were withdrawn for biochemical analysis.
15988516|NCT02974478|Dietary Supplement|Orange juice with meals|orange juice (20% of energy requirement/day)
15988517|NCT02974478|Dietary Supplement|Orange juice between meals|orange juice (20% of energy requirement/day)
15988518|NCT02974478|Dietary Supplement|Sugar sweetened beverage between meals|Sugar sweetened beverage (20% of energy requirement/day)
15988519|NCT02974465|Procedure|Biofeedback Electromyography|protocol of sEMG-BFB that consisted of active movements in glenohumeral abduction guided by the visual signal of the register equipment. The protocol was the following: firstly proof active movements were requested in glenohumeral abduction without feeling any pain in order to teach the visual signal of their muscle activity. The therapist dedicated around 10 minutes in each session for subject learned to control the activation of both muscles in the limits that physical therapist marked with each individual in particular (controlling the activation in the upper trapezius). Once integrated information, shoulder abduction were requested following 4 main principles.
15988520|NCT02974465|Procedure|Sham Biofeedback Electromyography|consisted of Sham-EMG biofeedback, in which the electrodes were placed as the same method as the EG (Fig. 2) but the screen emit no signal. The subject performed 3 sequences of 10 abduction contractions (first degrees) without pain feeling and with 5 minutes of rest between sequences.
15988521|NCT02974465|Procedure|Conventional Physical Therapy Treatment|All participants received a conventional daily treatment of neurological physical therapy. Since no evidence has been found about a specific therapy that specially could benefit hemiparesis consequences, the common approach in this center consists of a combination of different specific concepts (Bobath, Brunnstrom, Rood, Johnstone, Propioceptive Neuromuscular Facilitation, Perfetti, Vojta, Motor Relearning Programme,…), exercise programs, electrotherapy, myofascial techniques, etc…
15988522|NCT02974439|Drug|LANDI-Amlodipine Besylate Tablet 5mg|LANDI-Amlodipine Besylate Tablet 5mg is a generic product manufactured by YangTZE River Pharmaceutical Group Shanghai Haini Pharmaceutical Co., Ltd.
15988523|NCT02974439|Drug|Norvasc Tablets 5mg|Norvasc Tablet 5mg will be used as a comparator drug for the BE study.
15988524|NCT02974426|Radiation|PORT-first|PORT administered at the first day of adjuvant therapy, using 3- dimensional conformal or intensity-modulated radiation, total dose of 50.4 Gy, 1.8 Gy once daily over 5.5 weeks.
15988525|NCT02974426|Radiation|PORT-last|PORT administered sequentially after participants received adjuvant chemotherapy for four cycles, using 3- dimensional conformal or intensity-modulated radiation, total dose of 50.4 Gy, 1.8 Gy once daily over 5.5 weeks.
15988526|NCT02974426|Drug|Platinum-based two drug chemotherapy (cisplatin/carboplatin + vinorelbine or cisplatin/carboplatin + pemetrexed regimen)|Cisplatin/ carboplatin + vinorelbine regimen for squamous cell lung carcinoma Cisplatin/carboplatin + pemetrexed regimen for lung adenocarcinoma
15988576|NCT02974062|Other|Lumbar stabilization exercise|Participants were trained using lumbar stabilization exercise based on their initial lumbar stability level. They were received a 30-minute exercise for 1 session in this study.
15988577|NCT02974049|Drug|Albendazole|"Subjects in Arms 1, 2, and 4 will receive 400mg of Albendazole
~Subjects in Arm 3 will receive 800mg of Albendazole"
15988527|NCT02974413|Behavioral|self-care supported|The intervention to be performed will be based on the principles and steps of supported self-care, guided by Behavior Change Protocol (Behavior Change Protocol - BCP) and consists of an educational program with quarterly meetings, and individual at home, through home visits, and group in the Basic Health Unit (BHU), in addition to telephone monitoring in the interval between two meetings. This intervention will be applied together adult men with type 2 diabetes who are randomized in the intervention group (IG) for six months. Thus, these men will take part in three meetings, individual or group, and will receive four telephone calls in between the face meetings. Our objective is to draw with this intervention by the participant, an individual plan of self-care, based on concretras goals and supports you in the implementation of this plan, in order to improve their self-efficacy in self-care and therefore glycemic control.The study will also include a Control Group (CG).
15988528|NCT02974400|Behavioral|Internet-based, CBT-oriented, guided self-help|The self-help program includes sessions regarding (1) cognitive model, (2) sleep hygiene, (3) mindfulness, (4) meta-cognition, (5) coping with voice hearing, (6) persecutory ideation, (7) worrying, (8) self-esteem, (9) depression, (10) social competence, and (11) relapse prevention.
15988529|NCT02974387|Drug|Fluorometholone(FML)|
15988530|NCT02974387|Drug|Loteprednol (Lotemax)|
15988531|NCT02974374|Drug|PF-06835919|Single or repeated, escalating dose
15988532|NCT02974374|Other|Placebo|Single or repeated, escalating dose
15988533|NCT02974361|Drug|Ibuprofen|
15988534|NCT02974361|Drug|Ibuprofen Lysine|
15988535|NCT02974361|Drug|Ibuprofen-LDH|
15988536|NCT02974348|Drug|Arthemeter-lumefantrine|Randomization codes were computer-generated by an offsite investigator and provided to a study nurse responsible for treatment allocation. All other study personnel were blinded to the treatment assignments, and patients were not informed of their treatment regimen. Participants from Group 1: AL, Group 2 : DHAP, Group3 : ASMQ were also given appointment card for days 1, 2, 3, 7, 14, 21, 28, 35 and 42 for clinical examination and blood smears. Blood was taken on filter paper on each of these visits.
15988537|NCT02974348|Drug|Artesunate mefloquine|Artequin® is an antimalarial drug presented as infant co-formulation of two separate drugs
15988538|NCT02974348|Drug|Dihydroartemisinin piperaquine|Malacur®. is an antimalarial drug presentad as co-formulation of two separate drugs
15988539|NCT02974348|Drug|Paracetamol|Paracetamol, is an antipyretic drug, presented as tablets or syrup in infants formulation
15988540|NCT02974348|Drug|Amoxicillin|Amoxicillin is an antibiotic with no reported activity on plasmodium
15988541|NCT02974348|Drug|Quinine|quinine sulphate is an antimalaria drug administered as a second line or rescue drug
15988542|NCT02974335|Behavioral|Interviews with Stakeholders|The information gained from stakeholders will be applied in an iterative process to develop a best-practice approach to screening patients, and to build the EHR tools (CDEs and CDS) that will be further tailored and tested in Phase 2, and then implemented in one clinic in Phase 3.
15988543|NCT02974322|Drug|GED-0301|GED-0301
15988544|NCT02974322|Drug|Placebo|Placebo
15988545|NCT02974309|Behavioral|Sleep Extension|All youth in this condition are asked to extend their sleep to 10 hours or at least one hour, whichever is longer
15988546|NCT02974309|Behavioral|Routine|All youth in this condition are asked to follow the routines set by their clinical care team.
15988547|NCT02974296|Device|transcranial magnetic stimulation|non invasive brain stimulation approach
15988548|NCT02974283|Other|Normobaric oxygen therapy|"In this study, it is simple to administer via oxygen storage facemask at flow rates of 10 L/min for 4 hours. This therapy start should within 1 hour after diagnosed ischemic stroke and uninterrupted during other treatments including r-tPA thrombolytic therapy and standard clinical treatment. .
~Other Names:"
15988549|NCT02974270|Drug|Leuprolide|
15988550|NCT02974257|Drug|Thiamine|Thiamine 500mg IV twice daily for 2 days
15988551|NCT02974257|Other|placebo|100mL normal saline IV every 12 hours for 2 days
15988552|NCT02974244|Drug|exenatide once weekly|exenatide treatment in the customary clinical care in the USA
15988553|NCT02974244|Drug|basal insulin|basal insulin treatment in the customary clinical care in USA
15988554|NCT02974231|Radiation|Intensity-modulated radiation therapy|
15988555|NCT02974205|Procedure|Jack brace|Rehabilitation after acute isolated PCL rupture with orthosis
15988556|NCT02974205|Device|Rehabilitation|Rehabilitation after acute isolated PCL rupture without orthosis
15988557|NCT02974205|Device|össur brace|Rehabilitation after acute isolated PCL rupture
15988558|NCT02974192|Other|Neopterin|Neopterin will be measured by using standard laboratory methods on the first day of admission.
15988559|NCT02974179|Biological|Subjects from Study AG-CLI-0206 who received AMG0001|Subjects from Study AG-CLI-0206 who received the study product AMG0001
15988560|NCT02974166|Other|Conventional Group|Rigid occlusal splints and medication (Ibuprofen and Cyclobenzaprine Hydrochloride) were made and prescribed under the dentist professor supervision. Likewise, speech therapists performed assessments, measurements, massages, stretches and therapeutic exercises for head, neck and mouth regions.
15988561|NCT02974166|Other|Osteopathic Group|Same assistance of Conventional Group, cited above, plus the osteopathic care during 20 to 30 minutes once a week during four weeks. The osteopathic treatment consisted in an individualized assessment of mobility restrictions of myofascial tissues and joints and the application of smooth techniques such myofascial release, membranous strain and counterstrain, muscle energy, cranial and high velocity and low amplitude.
15988562|NCT02974166|Drug|Ibuprofen|The medication was prescribed by the dentist as nonsteroidal anti-inflammatory drug if necessary.
15988563|NCT02974166|Drug|Cyclobenzaprine Hydrochloride|The medication was prescribed by the dentist as muscle relaxer if necessary.
15988564|NCT02974153|Biological|ALD403 (Eptinezumab)|
15988565|NCT02974153|Biological|Placebo|
15988566|NCT02974140|Device|Cataract Refractive Suite (CRS)|Configuration consisting of Verion™ Image Guided System, LenSx® Laser and ORA™ System with VerifEye+™ (with or without VerifEye Lynk), combined for use in surgical pre-op planning and during cataract surgery
15988567|NCT02974140|Procedure|Standard manual technique|Standard biometry for intra-ocular lens (IOL) calculation and cataract removal using phacoemulsification technique
15988568|NCT02974127|Radiation|Radiotherapy|Multisession radiosurgery
15988578|NCT02974049|Drug|Ivermectin|Subjects in Arms 1 and 4 will receive 200mg/kg body weight
15988579|NCT02974049|Drug|Diethylcarbamazine|Participants in Arm 4 will receive 6mg/kg of Diethylcarbamazine per body weight
15988580|NCT02974036|Other|Patient education for osteoarthritis|Group sessions and optional supervised exercise.
15988581|NCT02974023|Device|Pain Gear|PainGear [ActiPatch®] (BioElectronics Corporation, MD, USA) has been recently introduced as an 'topical' analgesic for localized musculoskeletal pain. PainGear is a noninvasive, low power, easy to use, pulsed shortwave therapy device for localized musculo¬skeletal pain.
15988582|NCT02974010|Drug|NRX-101 Oral Capsule|Prospective Randomized Factorial Design Study as per arm/group descriptions
15988583|NCT02974010|Drug|Lurasidone Oral Capsule|Prospective Randomized Factorial Design Study as per arm/group descriptions
15988584|NCT02974010|Drug|Ketamine Intravenous Infusion|Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
15988585|NCT02974010|Drug|Saline Solution Intravenous Infusion|Randomized administration of Ketamine or Placebo in a 3 to 1 ratio
15988586|NCT02973997|Other|Laboratory Biomarker Analysis|Correlative studies
15988587|NCT02973997|Drug|Lenvatinib|Given PO
15988588|NCT02973997|Drug|Lenvatinib Mesylate|Given PO
15988589|NCT02973997|Biological|Pembrolizumab|Given IV
15988590|NCT02973958|Drug|Bupivacaine|See active comparator description
15988591|NCT02973958|Drug|Sevoflurane|See active comparator description
15988592|NCT02973958|Drug|Acetaminophen|See active comparator description
15988593|NCT02973958|Drug|Ibuprofen|See active comparator description
15988594|NCT02973958|Drug|Ketorolac|See experimental arm description
15988595|NCT02973945|Device|High Flow Nasal Cannula|"During the pulmonary rehabilitation program, patients will train the aerobic capacity on a treadmill. Patients in the intervention arm will receive oxygen trough High Flow Nasal Cannula (HFNC) at 50 lpm and 40% of oxygen.
~The aerobic capacity training plan will be conducted three times a week over 24 sessions."
15988596|NCT02973945|Device|The Venturi Mask|"During the pulmonary rehabilitation program, patients will train the aerobic capacity on a treadmill. Patients in the control arm will receive oxygen trough The Venturi Mask (VM) at 40% of oxygen.
~The aerobic capacity training plan will be conducted three times a week over 24 sessions."
15988597|NCT02973932|Behavioral|Cognitive-bahavioral psychotherapy|
15988598|NCT02973919|Behavioral|Eye Movement Desensitization and Reprocessing Therapy|In 1989, Shapiro discovered that while talking about negative life events or thoughts, rhythmic eye movements on a horizontal axis can alleviate the associated vividness and burden (Shapiro, 1989). She established the psychodynamic-behavioral Eye Movement Desensitization and Reprocessing (EMDR) Therapy, which includes the induction of rhythmic eye movements as a central feature. EMDR is regarded as an efficient treatment tool. Several times it has also been successfully applied in the field of specific phobias (de Jongh, ten Broeke, & Renssen, 1999; de Jongh, Holmshaw, Carswell, & van Wijk, 2011; Lapsekili & Yelboga, 2014; Muris, Merckelbach, van Haaften, & Mayer, 1997) and there is a standard protocol for using EMDR on specific fears and phobias (de Jongh, 2015).
15988599|NCT02973919|Behavioral|Virtual Reality Exposure Therapy|Exposure to fear-evoking stimuli is conducted more often in virtual environments using simulators or similar computer-technologies (Virtual Reality Exposure Therapy, VRET). One great advantage of using VR-technologies is that it is possible to create an environment which is highly controllable by its creators. Feared stimuli or scenarios can be varied on individual purposes and presented several times. This facili- tates the practice of exposure-based treatments especially for situations or places diffi- cult to access or requiring a considerable amount of time and/or money (e.g. being in war zones or a passenger on a flight), where in vivo exposures have often not been con- ducted or only in a limited manner (Mühlberger & Pauli, 2011).
15988600|NCT02973906|Other|ADAPT Self Directed web|In the self-directed web-only ADAPT condition, participants have access to the full ADAPT website (10 modules, online discussion forum
15988601|NCT02973906|Other|ADAPT individualized web-facilitated|This condition comprises access to the full ADAPT web program as described above, with augmentation of individual facilitator web support (i.e. the facilitator connects via Google Hangout). Facilitators meet with families at a mutually convenient time weekly (10-14 weeks, approximately 3 sessions per month).
15988602|NCT02973906|Other|Group-based ADAPT|Groups will meet weekly for 120 minutes, at a time convenient to participants (usually early evening). Groups cover core ADAPT/PMTO topics:
15988603|NCT02973893|Biological|Placebo|Placebo
15988604|NCT02973893|Biological|VF001-DP LD|VF001-DP contains parts of normal vitronectin and Insulin-like growth factor 1 (IGF-I) combined in a single protein.
15988605|NCT02973893|Biological|VF001-DP HD|VF001-DP contains parts of normal vitronectin and Insulin-like growth factor 1 (IGF-I) combined in a single protein.
15988606|NCT02973880|Drug|NETILDEX™ ophthalmic gel|"1 drop of NETILDEX™ (Netilmicin Sulfate 3mg/ml / Dexamethasone Disodium Phosphate 1mg/ml) ophthalmic gel immediately after the surgery then 1 drop twice daily (b.i.d.) from Day 1 until Day 14 after surgery + 1 drop of XANTERGEL™ ophthalmic gel twice daily (b.i.d.) from Day 1 until Day 14 after surgery.
~Bromfenac 0.9 mg/ml 1 drop twice daily (b.i.d.) for 3 days before cataract surgery."
15988607|NCT02973880|Drug|NETILDEX™ eye drops solution|"1 drop of NETILDEX™ (Netilmicin Sulfate 3mg/ml / Dexamethasone Disodium Phosphate 1mg/ml) eye drops solution immediately after the surgery then 1 drop four times a day (q.i.d.) from Day 1 until Day 14 after surgery.
~Bromfenac 0.9 mg/ml 1 drop twice daily (b.i.d.) for 3 days before cataract surgery."
15988608|NCT02973841|Device|Sono-ease device|insertion of US guided IJV using sono-ease device
15988609|NCT02973828|Procedure|Imaging|This is an observational study only, with no interventions. Volunteers will undergo MRI imaging on the MR Linac, however this will not affect, change or initiate any intervention, or change to their care path.
15988610|NCT02973815|Behavioral|NU-HOME Intervention|The NU-HOME family intervention program consists of seven monthly group sessions, individual goal setting calls and online materials to support the sessions. The intervention focuses on promoting healthful family meals where parents and children cook and eat together, healthful home food and physical activity environments, and being active together as a family.
15988611|NCT02973802|Biological|ATX-GD-59|Disease specific immune modulating treatment for Graves Disease
15988699|NCT02973204|Procedure|Radiofrequency ablation (RFA) or surgery|Intended curative surgery or RFA
15988700|NCT02973204|Drug|Everolimus|
15988612|NCT02973789|Device|NovoTTF-100L|Patients receive continuous TTFields treatment using the NovoTTF-100L device. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the chest. The treatment enables the patient to maintain regular daily routine.
15988613|NCT02973789|Drug|Immune checkpoint inhibitors or docetaxel|Patients receive standard of care with Immune checkpoint inhibitors or docetaxel
15988614|NCT02973776|Drug|LEO 90100 aerosol foam|
15988615|NCT02973776|Drug|Dermoval®/Dermovate®|
15988616|NCT02973776|Drug|Diprosone|
15988617|NCT02973776|Drug|Elocon|
15988618|NCT02973776|Drug|Locoid|
15988619|NCT02973776|Other|LEO 90100 foam vehicle|
15988620|NCT02973763|Drug|Alflutinib|
15988621|NCT02973750|Procedure|Baseline Biopsy|Baseline biopsy (and ascites fluid sampling if applicable). This is done during the normal work-up procedures.
15988622|NCT02973750|Procedure|Tissue Collection|Tissue collection during debulking surgery.
15988623|NCT02973750|Procedure|Blood Draws|Blood samples for paclitaxel and carboplatin plasma levels will be collected in the study. Paclitaxel will be measured on cycle 1 day 1 at predose and then at the end of the infusion, followed by 1, 2, 4, 8 hours after the end of infusion, then on cycle 1 day 2 at 24 hours after the end of infusion. Carboplatin will be sampled for on cycle 1 day 1 at predose and then at the end of the infusion, followed by 0.5, 1.5, 3.5, 7.5 hours after the end of infusion, then on cycle 1 day 2 at 23.5 hours after the end of infusion.
15988624|NCT02973737|Drug|pyrotinib|400 mg once daily
15988625|NCT02973737|Drug|placebo|400 mg once daily
15988626|NCT02973737|Drug|Capecitabine|1000 mg/m2 per day on day 1 through 14, every 21 days.
15988627|NCT02973724|Drug|Remifentanil|The concentration of remifentanil was determined by biased-coin up and down design, starting from 1.0 ng/ml (0.4 ng/ml as a step size)
15988628|NCT02973724|Drug|Propofol anesthesia|Anesthesia was induced with propofol target-controlled infusion at an effect-site concentration of 5.0 μg/ml.
15988629|NCT02973711|Drug|Nilotinib|Nilotinib 300 mg BID
15988630|NCT02973711|Drug|Ruxolitinib|Ruxolitinib, 10, 15 or 20mg BID
15988631|NCT02973698|Other|chin-down posture maneuver|it was performed the training of Chin-down postural maneuver with saliva and water. Besides, the subjects received instructions regarding feeding.
15988632|NCT02973698|Other|Orientations about swallowing|The instructions about feeding were performed. The individuals received all the instructions on a written document.
15988633|NCT02973698|Other|Control|No intervention will do
15988634|NCT02973685|Procedure|Hepatic arterial infusion chemotherapy|A standard hepatic artery catheter was introduced via the femoral artery percutaneously. Selective catheterization of the proper hepatic artery was performed using standard diagnostic catheters and fluoroscopic guidance. In the event of multiple arterial supply(including superior-mesenteric artery), the proportion of the liver supplied by each artery was estimated by the arteriogram. After optimal positioning of the catheter in dominant supplying artery to ensure minimal reflux, the catheter was fixed and connected with infusion tube. In the condition of multiple tumors on both left and right lobe, the gastroduodenal artery was embolized and the catheter was positioned in the hepatic proper artery for infusion. Folfox Protocol were infused through the fixed catheter sequentially.
15988635|NCT02973685|Procedure|Transarterial chemoembolization|Previous procedure was same with hepatic arterial infusion chemotherapy. After optimal positioning of the catheter, TACE Drug Protocol were injected.
15988636|NCT02973685|Drug|Folfox Protocol|oxaliplatin,leucovorin and 5-FU
15988637|NCT02973685|Drug|TACE Drug Protocol|lipiodol mixed with chemotherapy drugs(EADM , lobaplatin, with or without MMC) followed by polyvinyl alcohol particles (PVA)
15988638|NCT02973672|Drug|SGM-101|4 days before surgery, SGM-101 will be administered to the patient by intravenous injections.
15988639|NCT02973659|Drug|Oxybutynin|10% oxybutynin gel (one side) Vs placebo aqueous gel (other side) - 2/d application, 1 month
15988640|NCT02973659|Drug|Placebos|
15988641|NCT02973646|Drug|Entecavir or Tenofovir|Patients in nucleos(t)ide analogues treatment for 12 weeks group will receive nucleos(t)ide analogs therapy (Entecavir tablet 0.5mg/d or Tenofovir tablet 300mg/d) from Week 25th to 36th.
15988642|NCT02973646|Drug|Peginterferon Alfa-2B|
15988643|NCT02973633|Device|Diffusion Tensor MRI (DTI)|Diffusion Tensor MRI (DTI) measures the diffusion of water in the heart, which allows the orientation of the muscle fibers in the heart to be determined.
15988644|NCT02973633|Drug|Gadolinium DOTA Meglumine|Late Gadolinium enhancement
15988645|NCT02973620|Drug|Levosimendan|levosimendan infusion started at 0.1 mcg/kg/min for 6-12 hours, increased to 0.2 mcg/kg/min for 24-36 hours
15988646|NCT02973607|Procedure|Nephrectomy|This is observational in design.
15988647|NCT02973594|Drug|Ivabradine|
15988648|NCT02973594|Drug|Placebo|
15988649|NCT02973581|Drug|Metamizol|in group A patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1-1,25 gram
15988650|NCT02973581|Drug|Acetaminophen|in group P patients will receive pre-emptive analgesia using intravenous infusion of acetaminophen in a single dose of 10-15 mg per kg of body weight
15988651|NCT02973581|Drug|0,5 % bupivacaine with of 2% lidocaine|in group PBB patients in group BF will receive regional peribulbar block using a solution of 0,5% bupivacaine (2,5 ml) with 2% lidocaine (2,5 ml)
15988652|NCT02973581|Drug|Proxymetacaine|in group T patients will receive topical analgesia using a solution of 0,5% Alcaine
15988653|NCT02973568|Other|Observational Study|
15988654|NCT02973555|Other|PRP injection|autologous intrauterine infusion of PRP
15988655|NCT02973542|Drug|Ethosuximide|The study will aim to evaluate the effectiveness of ethosuximide on abdominal pain in patients with IBS, its tolerance and its impact on patient quality of life, severity of symptoms related to IBS and the use of analgesics / antispasmodic / regulators transit.
15988656|NCT02973542|Other|Placebo|The study will aim to evaluate the effectiveness of ethosuximide on abdominal pain in patients with IBS, its tolerance and its impact on patient quality of life, severity of symptoms related to IBS and the use of analgesics / antispasmodic / regulators transit.
15988657|NCT02973529|Device|Absorb|Randomization to implantation of Absorb BVS in bifurcation lesion
15988658|NCT02973529|Device|Desolve|Randomization to implantation of Desolve BRS in bifurcation lesion
15988701|NCT02973204|Drug|Lanreotide|Or other somatostatin analogues (SSTA), eg. Sandostatin
15988661|NCT02973503|Drug|Elbasvir/Grazoprevir Fixed Dose Combination|Evaluate the efficacy of Elbasvir/Grazoprevir Fixed-Dose Combination for 8 Weeks in Treatment-Naïve, HCV GT1b-Infected Patients, with non- severe fibrosis as measured by the proportion of subjects with sustained viral response 12 weeks after cessation of treatment (SVR 12).
15988662|NCT02973490|Device|Transanal Tube Drainage|Using transanal tube drainage after colorectal ESD
15988663|NCT02973477|Drug|Dapagliflozin|Dapagliflozin is a sodium glucose transporter-2 (SGLT-2) inhibitor, a new class of glucose lowering agent that reduces hyperglycemia in patients with T2D by reducing renal glucose reabsorption.
15988664|NCT02973477|Drug|Glimepiride|Glimepiride is a sulfonylurea agent that reduces hyperglycemia in patients with T2D by stimulating insulin release from the pancreatic beta cells and reduction of glucose output from the liver.
15988665|NCT02973464|Drug|Valganciclovir|Oral at a dose of 450mg or 900mg per day begin within 10 days till to Day 100 posttransplant
15988666|NCT02973464|Drug|Ganciclovir|intravenous GCV 5mg/kg/d after renal transplantation for the first 14 days, and then oral GCV 1g 3 times daily till to Day 100 posttransplant.
15988667|NCT02973451|Drug|Laparoscopic Guided Bupivacaine|Bupivacaine Laparoscopic GuidedTransversus Abdominis Plane Block
15988668|NCT02973451|Drug|local Bupivacaine|Bupivacaine Trocar Site Infiltration
15988669|NCT02973438|Device|Intermittent Hypoxia (IH)|Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute hypoxic intervals (FIO2 = 0.09-0.12) with 3-minute normoxic intervals (FIO2 = 0.21). During hypoxic intervals, oxygen concentration may be adjusted to maintain participants SpO2 levels between 75-90%.
15988670|NCT02973438|Device|SHAM|Administered over a period of 5 consecutive days involving daily, hour long sessions of alternating 6-minute normoxic intervals (FIO2 = 0.21) with 3-minute normoxic intervals (FIO2 = 0.21).
15988671|NCT02973425|Behavioral|Take a Break as an augmentation to NRT-sampling in Motivation Phase|NRT sampling experience & Suite of mHealth motivational tools and mini-games.
15988672|NCT02973425|Behavioral|NRT and mHealth assessment tool without feedback|NRT and mHealth assessment tool without feedback
15988673|NCT02973399|Drug|SNX-5422 plus ibrutinib|SNX-5422 capsule(s) dosed every other day for 21 days out of a 28-day treatment cycle to a total dose of 56 mg/m2 SNX-5422. Subjects will self-administer daily oral ibrutinib in the afternoon at least 8 hours apart from SNX-5422 for 28 days of each cycle.
15988674|NCT02973386|Drug|IMRT combine with cisplatin concurrent chemotherapy|Patients in the control arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1 and day 22) during RT.
15988675|NCT02973386|Drug|IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy|Patients in the experimental arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1 and day 22) during RT,followed by adjuvant chemotherapy with oral capecitabine(1000mg/m2/ twice a day for 14 days)every three weeks for eight cycles at 4 weeks later after RT.
15988676|NCT02973373|Device|MRI with High-frequency non-invasive ventilation|MRI performed under high-frequency non-invasive ventilation
15988677|NCT02973373|Other|MRI without High-frequency non-invasive ventilation|MRI performed without High-frequency non-invasive ventilation
15988678|NCT02973360|Drug|Docosahexaenoic Acid|Oral Capsule
15988679|NCT02973360|Drug|Placebo|Oral Capsule
15988680|NCT02973347|Other|Intermittent enteral feeding|The intervention is the schedule under which ventilated children are offered enteral feeding attempts: feed administered via the nasogastric tube less than 30 mins.
15988681|NCT02973347|Other|Continuous enteral feeding|The intervention is the schedule under which ventilated children are offered enteral feeding attempts: feed administered via the nasogastric tube for 24 hours.
15988682|NCT02973334|Other|Ingestion of artificially-sweetened beverages|From t=60 to the end of the metabolic test, volunteers will ingest 7 beverages containing non nutritive sweeteners (25 mL / beverage) every 15 minutes after 10-sec mouth rinsing.
15988683|NCT02973334|Other|Ingestion of sugar-sweetened beverages|From t=60 to the end of the metabolic test, volunteers will ingest 7 beverages containing sugar (25 mL / beverage) every 15 minutes after 10-sec mouth rinsing.
15988684|NCT02973334|Other|Ingestion of water|From t=60 to the end of the metabolic test, volunteers will ingest 7 water beverages (25 mL / beverage) every 15 minutes after 10-sec mouth rinsing.
15988685|NCT02973321|Drug|SAR425899|Self-administered by SC injection using a solution for injection in cartridge.
15988686|NCT02973321|Drug|Placebo|Self-administered by SC injection using a solution for injection in cartridge.
15988687|NCT02973321|Drug|Liraglutide|Self-administered by SC injection using a pre-filled pen.
15988688|NCT02973321|Drug|Metformin|Orally administered at a stable dose , >=1500 mg daily stable dose or maximal tolerated dose.
15988689|NCT02973308|Other|Observer|Observer A and observer B
15988690|NCT02973295|Drug|Silymarin|Capsules contains 100 mg of silymarin
15988691|NCT02973295|Other|Placebo Oral Capsule|Capsule will be identical in shape, size and color, packed in the same way like verum
15988692|NCT02973282|Other|Recording of Infants and Children's Cough Sounds|Smartphone recordings of the cough sounds of infants and children presenting to a participating site with signs or symptoms of respiratory disease
15988693|NCT02973269|Biological|daxibotulinumtoxin type A|Intramuscular injection
15988694|NCT02973269|Biological|Placebo|Intramuscular injection
15988695|NCT02973243|Device|Automatic RR Measurement|Different newly developed respiration rate sensors are applied at the bedside during the intervention phase which send data to the IntelliVue Guardian System.
15988696|NCT02973230|Other|Dosage of VEGF serum concentration|Blood samples were collected by peripheral venous puncture before treatment; a total 15 mL of blood was withdrawn (2 mL for β-hCG, 3mL for progesterone, 10 mL for VEGF determinations). Blood samples for VEGF were collected in siliconized tubes and were allowed to coagulate at room temperature for 2-6 hours.
15988697|NCT02973217|Device|Immunostimulating Interstitial Laser Thermotherapy|
15988698|NCT02973204|Drug|Sorafenib|
15988703|NCT02973178|Device|Scanadu Urine Device|Device to allow lay user to perform urinalysis test at home.
15988704|NCT02973152|Procedure|Thyroplasty|This medialisation/augmentation technique is a static technique, performed under local anaesthesia that aims to improve the positioning of the paralysed vocal fold. It uses a silastic implant readily available in different sizes according to size of larynx and gender of the patient. The correct size can be determined intraoperatively by using a measuring device while listening and visualising the larynx with flexible fiberoptic scope simultaneously.
15988705|NCT02973152|Procedure|Reinnervation|For laryngeal reinnervation, ansa cervicalis to recurrent laryngeal nerve repair technique will be used. In this technique, the functioning ansa cervicalis nerve that overlies the internal jugular vein and the distal stump of injured recurrent laryngeal nerve (RLN) will be identified and anastomosed without tension (Crumley RL. Teflon versus thyroplasty versus nerve transfer: a comparison. The Annals of otology, rhinology, and laryngology. 1990;99(10 Pt 1):759-63).
15988706|NCT02973139|Other|Medical Thoracoscopy|Medical thoracoscopy will be performed as per standard protocols.
15988707|NCT02973139|Other|Fibrinolytic Group|Patients will receive intrapleural combination of TPA (10 mg) and DNAse (5 mg). Therapy will be given twice daily for a maximum of 6 doses
15988708|NCT02973126|Procedure|FFRct and SPECT|enable the comparison of diagnostic performance of FFRct and SPECT in subjects with suspected stable CAD after abnormal SPECT imaging who have no contraindications to coronary computed tomography angiography (CCTA).
15988709|NCT02973113|Biological|EBVST Cells|EBVST cells in an expected volume of 10-20cc will be given by intravenous injection over 2-10 minutes through either a peripheral or a central line.
15988710|NCT02973113|Biological|Nivolumab|Nivolumab 3mg/kg (max dose: 240 mg) will be administered as an intravenous infusion over 60 minutes.
15988711|NCT02973100|Drug|Dulaglutide|Administered SC
15988712|NCT02973100|Drug|Placebo|Administered SC
15988713|NCT02973087|Biological|von Willebrand factor (Recombinant)|OD participants will receive intravenous (IV) rVWF:RCo at an initial prophylactic dose of 50 +/- 10 International Unit per Kilogram (IU/kg) twice (two infusions) a week for at least 12 months up to 15 months and may be increased up to 80 IU/kg. pdVWF switch cohort participants will receive rVWF:RCo equivalent (± 10%) to the weekly VWF dose received during prophylactic treatment with pdVWF.
15988714|NCT02973087|Biological|Antihemophilic Factor (Recombinant)|During prophylaxis period any bleeding episodes requiring substitution therapy with VWF concentrate to control bleeding will be treated with rVWF with or without ADVATE. Participants will receive rFVIII IV if necessary for OD treatment of breakthrough bleeds or for peri-operative. The dose will be according to the bleeding type and severity and it will be adjusted to the clinical response.
15988715|NCT02973074|Dietary Supplement|OLEOvital|2sachets with 30mg iron per day for a 4 weeks period
15988716|NCT02973061|Other|Questionnaires|All participants families will fulfill a periodic questionnaire regarding attention, behaviour.
15988717|NCT02973048|Drug|Hyperbaric bupivacaine|The dose of 10 mg of hyperbaric bupivacaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
15988718|NCT02973048|Drug|Hyperbaric prilocaine|The dose of 50 mg of hyperbaric prilocaine will be administered to one of two groups intrathecally and the quality of sensory and motor block as well as side-effects will be observed at precise time points.
15988719|NCT02973035|Drug|Amlodipine|
15988720|NCT02973035|Drug|Valsartan|
15988721|NCT02973022|Other|CC&S|Three educational modules -- Cancer Basics, Cancer Prevention, and Cancer Screening -- intended to increase cancer awareness. The full CC&S curriculum is currently available at http://chdi.wisc.edu/cancer-clear-simple-curriculum-rural-adaptation.
15988722|NCT02972996|Other|Blueberry|22 g freeze-dried whole blueberry powder
15988723|NCT02972996|Other|Placebo|22 g placebo blueberry powder
15988724|NCT02972983|Drug|Daptomycin|Adjuvant therapy for up to five days
15988725|NCT02972983|Other|Placebo|Placebo
15988726|NCT02972970|Device|Aveera|Subjects will use the 3D crafted CPAP mask. All subjects will receive a mask to use
15988727|NCT02972957|Biological|Nasovac-S|one of 0.5ml intranasal dose of trivalent live attenuated vaccine (LAIV)
15988728|NCT02972957|Drug|Azithromycin|a single dose of Azithromycin (liquid formulation - Zithromax) at 20mg/Kg (up to a maximum adult dose 1g) to be given to a subset of subjects
15988731|NCT02972918|Drug|Levosimendan|24h preoperative infusion of levosimendan (0,1 mcg/Kg/min)
15988732|NCT02972905|Drug|GSK2269557 ELLIPTA DPI|GSK2269557 ELLIPTA DPI contains GSK2269557 blended with lactose and magnesium stearate. This will be supplied in two strength of 100 mcg per blister and 500 mcg per blister.
15988733|NCT02972905|Drug|Placebo ELLIPTA DPI|Placebo ELLIPTA DPI contains lactose
15988734|NCT02972879|Procedure|Therapeutic modalities: Orthotic (Group 1)|participants will be instructed to remove the orthosis only two hours in the morning, two hours in the afternoon and two hours at night to avoid joint stiffness
15988735|NCT02972879|Procedure|Therapeutic modalities: LLLT (Group 2)|"The LLLT parameters are:
~LASER 904nm
~P: 1.5W/cm²
~30mV/cm²
~Area 2 cm²
~1 Joule por ponto ( in the A1 pulley)"
15988736|NCT02972879|Procedure|Therapeutic modalities: Paraffin (Group 3)|"Paraffin will be heated and maintained at 50 ° C. Participants will immerse their affected hand 10 times in heated paraffin, then they will roll up their affected hand in a towel that they will bring, after 20 minutes timed by a trained professional, the subjects will remove the towel and paraffin glove:"
15988737|NCT02972879|Procedure|Corticosteroid injection (Group 4)|The injection solution is composed of 1 ml of betamethasone and 1 ml of 2% lidocaine.This group may repeat the procedure in two weeks if they report that there was no improvement of the triggering or pain.
15988738|NCT02972866|Drug|Budesonide|Suspention to nasal use, 2 atomization in each nostril during the morning and at night.
15988740|NCT02972840|Drug|Acalabrutinib|Administered orally (PO)
15988741|NCT02972840|Drug|Bendamustine|Administered intravenously (IV)
15988742|NCT02972840|Drug|Rituximab|Administered intravenously (IV)
15988744|NCT02972827|Device|NICOM/FloTrac|Use of noninvasive cardiac output and minimally invasive cardiac output monitors
15988745|NCT02972827|Other|Crystalloid Fluid Challenge|500-1000ml Normal Saline or Plasmalyte intravenous fluid bolus will be given at baseline, and following a positive passive leg raise response as defined by a 10% or greater increase in any of: stroke volume index, cardiac index, or pulse pressure, as measured by the NICOM or FloTrac Monitors.
15988746|NCT02972814|Device|Laboratory based troponin test|acquisition of blood troponin level by Roche Cobas E 603
15988747|NCT02972814|Device|Point of care based troponin test 1|acquisition of blood troponin level by Radiometer EQT 90 Flex
15988748|NCT02972814|Device|Point of care based troponin test 2|acquisition of blood troponin level by Philips Minicare I-20
15988749|NCT02972801|Procedure|Testicular biopsy|Testicular biopsy is performed to obtain testicular tissue for cryopreservation
15988750|NCT02972788|Drug|Enamel Matrix Proteins Derivative|Enamel matrix proteins derivative will be placed in deep periodontal pocket during routine periodontal maintenance therapy.
15988751|NCT02972788|Other|Saline|Saline will be placed in deep periodontal pocket during routine periodontal maintenance therapy.
15988752|NCT02972775|Other|no interventions. observational study|
15988753|NCT02972762|Drug|Diprivan|anesthesia will be maintained with remifentanil and Diprivan.we use Diprivan close-loop to control the anesthesia depth,and the anesthesia depth will be detected with BIS machine.the usage of remifentanil、ropivacaine、sufentanil and cisatracurium in both arms is no difference.
15988754|NCT02972749|Behavioral|Intervention|Recommendations for lifestyle changes which have shown to reduce IOP. recommendations include: Moderate aerobic exercise, High fiber diet, sleeping with a head elevation and moderating caffeine intake. while continuing prescribed medical therapy.
15988755|NCT02972736|Radiation|Radiation dose expressed as DAP|
15988756|NCT02972723|Drug|Metformin|Oral Metformin 1g bd. (total = 2g per day) for 14 days
15988757|NCT02972710|Other|Supine thoracic spine thrust manipulation|The participant will be positioned so that small amplitude quick stretch can be applied to the least mobile area of the thoracic spine that is identified during the spinal segmental mobility testing. The thoracic spine thrust manipulation will be applied at an appropriate range of motion as identified by the clinician.
15988758|NCT02972710|Other|Seated thoracic spine thrust manipulation|The participant will be positioned so that small amplitude quick stretch can be applied to the least mobile area of the thoracic spine that is identified during the spinal segmental mobility testing. The thoracic spine thrust manipulation will be applied at an appropriate range of motion as identified by the clinician.
15988759|NCT02972697|Radiation|11C-acetate ligand|
15988760|NCT02972697|Radiation|FDG ligand|
15988761|NCT02972684|Device|Thrombo-elastometry POC testing|Use of thrombo-elastometry point of care test and algorithm guided predetermined intervention during peri operative haemorrhage
15988762|NCT02972671|Device|MiStent (MT005) Coronary Artery Stent|Implantation of a coronary artery stent in an all-comers population, including patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for percutaneous coronary interventions
15988763|NCT02972671|Device|Xience Coronary Artery Stent|Implantation of a coronary artery stent in an all-comers population, including patients with symptomatic coronary artery disease including patients with chronic stable angina, silent ischemia, and acute coronary syndromes, who qualify for percutaneous coronary interventions
15988764|NCT02972658|Drug|Lanabecestat|Administered orally
15988765|NCT02972645|Drug|LY3305677|Administered SC
15988766|NCT02972645|Drug|Placebo|Administered SC
15988767|NCT02972632|Drug|Vortioxetine|Vortioxetine tablet
15988768|NCT02972619|Other|Structured Multicomponent Intervention (MCI)|Multicomponent Intervention (MCI) includes 1) algorithm-driven antihypertensive treatment for all hypertensive individuals using fixed-dose combination (FDC) and lipid lowering for high risk hypertensive individuals, 2) motivational conversation for high-risk hypertensive individuals and 3) telephone based follow-ups of all hypertensive individuals by a team of physician supervised nurse, and 4) discounts on FDC antihypertensive medications
15988769|NCT02972593|Biological|Blood and blood products for transfusion|Randomization would not occur until the patient's Hgb dropped below 7 g/dL. If the patient is randomized to the liberal arm, they would be transfused to keep their Hgb >7 g/dL. If the patient is randomized to the conservative arm, they would not be transfused until their Hgb drops below 5.5 g/dL. If the patient's Hgb does not drop below 7.0 g/dL, randomization will not be done.
15988770|NCT02972580|Genetic|Genetic characterization|Confirmatory genetic testing for mutation in DMD gene (Carrier Status) for subjects in respective Cohorts
15988771|NCT02972567|Dietary Supplement|Lactobacillus spp|9 log10 cfu/capsule. 1 capsule/day for 12 weeks
15988772|NCT02972567|Dietary Supplement|Control|Maltodextrin
15988773|NCT02972554|Drug|Propanolol hydrochloride|One-time dose of 40mg of propranolol
15988774|NCT02972554|Other|Placebo|Outside casing matching that of active drug
15988775|NCT02972541|Device|Stenting with neoadjuvant chemotherapy|After clinical success of colonic stenting, patients will be given neoadjuvant chemotherapy. Surgery is performed after 3 cycles of mFOLFOX6 or 2 cycles of CapeOx. The choice of surgery performed is up to the individual consultant colorectal surgeon. Patients will receive 5-9 cycles of mFOLFOX6 or 4-6 cycles of CapeoX after surgery. Each cycle of mFOLFOX6 consists of racemic leucovorin 400 mg/m², oxaliplatin 85 mg/m² in a 2-h infusion, bolus fluorouracil 400 mg/m² on day 1, and a 46-h infusion of fluorouracil 2400 mg/m². Each cycle of CapeOx consists of oxaliplatin 130 mg/m2, capecitabine 100 mg/m2 twice daily for 14 days.
15988776|NCT02972541|Device|Stenting with immediate Surgery|After clinical success of colonic stenting, patients will undergo surgery 7-14 days later. The choice of surgery performed is up to the individual consultant colorectal surgeon. Patients will receive 8-12 cycles of mFOLFOX6 or 6-8 cycles of CapeoX after surgery. Each cycle of mFOLFOX6 consists of racemic leucovorin 400 mg/m², oxaliplatin 85 mg/m² in a 2-h infusion, bolus fluorouracil 400 mg/m² on day 1, and a 46-h infusion of fluorouracil 2400 mg/m². Each cycle of CapeOx consists of oxaliplatin 130 mg/m2, capecitabine 100 mg/m2 twice daily for 14 days.
15988777|NCT02972528|Biological|Platelet Lysate|Direct injection of allogenic Platelet Lysate
15988778|NCT02972528|Biological|Platelet Poor Plasma|Direct injection of allogenic Platelet Poor Plasma
15989249|NCT02969057|Other|Breakfast with rice bran oil|25 grams of rice bran oil
15988779|NCT02972515|Behavioral|See Me Smoke-Free|See Me Smoke-Free is a multi-behavioral mobile application focusing on increasing smoking cessation, healthy eating, and moderate to intense physical activity. The app tracks the participant's quit date, and eating/physical activity goals. Participants have access to guided imagery audio files that they are instructed to listen to every day for at least 30 days. Participants can earn awards for meeting the study goals.
15988780|NCT02972515|Device|Smart phone|See Me Smoke-Free mHealth app delivered via a smart phone
15988781|NCT02972502|Drug|Metoclopramide|Patients receive 10 mg of intravenous (IV) metoclopramide.
15988782|NCT02972502|Drug|Haloperidol|Patients receive 2.5 mg of IV haloperidol.
15988783|NCT02972502|Other|Normal Saline|All patients receive a 1-liter bolus of normal saline (NS)
15988784|NCT02972502|Drug|Diphenhydramine|All patients receive 25 mg of intravenous (IV) diphenhydramine.
15988785|NCT02972489|Device|3D OFDI guidance arm|Subjects randomized to 3D-guidance arm will undergo optical frequency domain imaging (OFDI) assessment in the main vessel after re-wiring into the jailed side branch following stent implantation. If the position of the wire is not located in the optimal cell, further attempts to redirect the wire to the optimal cell will be performed, with subsequent OFDI acquisitions to confirm position in 2D and off-line 3D reconstruction. After procedure, OFDI is performed in the main branch.
15988786|NCT02972489|Device|Angio guidance arm|In angiography-guidance group, wire recrossing into the side branch will be performed using conventional fluoroscopic/angiographic guidance. After finishing the procedure, OFDI is performed in the main branch but the results will be blinded to the operators.
15988787|NCT02972476|Drug|Budesonide & formoterol fumarate and Aclidinium bromide|
15988788|NCT02972476|Drug|Fluticasone 500 & salmeterol and Aclidinium bromide|
15988789|NCT02972476|Drug|Fluticasone 250 & salmeterol and Aclidinium bromide|
15988790|NCT02972476|Drug|Aclidinium bromide & formoterol fumarate|
15988791|NCT02972463|Dietary Supplement|Immunoglobulin Y|
15988792|NCT02972463|Other|Placebo|
15988793|NCT02972450|Biological|GTU-MultiHIV B-clade vaccine + MVA HIV-B HIV vaccine|"The vaccine is a solution of HIV MVA vectors (see section 1.3.2) in S08 buffer (10mM Tris/hydrochloride (Tris/HCl), Saccharose 5% (w/v), 10mM Sodium Glutamate (Na Glu), 50mM Sodium Chloride (NaCl), water PPI, pH 8.0).
~0.5ml of ANRS MVA HIV-B (1 x 108 pfu/ml) or placebo for MVA (S8 buffer) will be administered intramuscularly in the deltoid muscle of the non-dominant upper arm. Participants will be observed for one hour after the injection."
15988794|NCT02972450|Biological|GTU-MultiHIV B-clade vaccine + MVA HIV-B HIV vaccine+ Vedolizumab|"The vaccine is a solution of HIV MVA vectors (see section 1.3.2) in S08 buffer (10mM Tris/hydrochloride (Tris/HCl), Saccharose 5% (w/v), 10mM Sodium Glutamate (Na Glu), 50mM Sodium Chloride (NaCl), water PPI, pH 8.0).
~0.5ml of ANRS MVA HIV-B (1 x 108 pfu/ml) or placebo for MVA (S8 buffer) will be administered intramuscularly in the deltoid muscle of the non-dominant upper arm. Participants will be observed for one hour after the injection. Vedolizumab is administered as an intravenous infusion over 30 mins in the dominant arm. After infusion, the line should be flushed with 30mls of normal saline."
15988795|NCT02972450|Drug|Vedolizumab 300 MG [Entyvio]|Vedolizumab is administered as an intravenous infusion over 30 mins in the dominant arm. After infusion, the line should be flushed with 30mls of normal saline.
15988796|NCT02972450|Other|Placebo|"Placebo for MVA it is a solution composed of S08 buffer (as for the MVA vaccine) that will be administered intramuscularly in the deltoid muscle of the non-dominant upper arm. Participants will be observed for one hour after the injection.
~Placebo for GTU-MultiHIV B-clade vaccine: Sodium Chloride (NaCl) for infusion, 0.9%.
~Placebo for Vedolizumab: Sodium Chloride (NaCl) for infusion, 0.9% in 250 ml infusion bags."
15988797|NCT02972437|Other|sample taking|throat culture and oral cavity sample
15988798|NCT02972424|Drug|Teriparatide Prefilled Syringe|TPTD 20 mcg
15988799|NCT02972424|Drug|Placebo|Matching placebo as a prefilled syringe with all inactive ingredients
15988800|NCT02972411|Behavioral|Voluntary ventilatory response|Training of the subjects for voluntary increase in the respiratory minute ventilation
15988801|NCT02972411|Drug|Acetazolamide|Acetazolamide 125mg. PO every 12 hours since 24 hours before ascent, until 48 hours at high altitude
15988804|NCT02972385|Procedure|Mouthwash sample|A one time mouthwash sample will be performed.
15988805|NCT02972385|Procedure|Blood Draw|Patients who are receiving a blood draw during their regular clinical appointment will be asked for a blood sample of 15 milliliters. Genomic DNA will be isolated for genotyping and patient plasma samples will also be stored.
15988806|NCT02972372|Procedure|CRT|"Drug: Capecitabine(Aibin) capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 weeks in total
~Other Names:
~Aibin Drug: Oxaliplatin(Aiheng) Oxaliplatin(Aiheng)：65mg/m2，d1，8, 22, 29,I.V.
~Other Names:
~Aiheng cisplatin: 75mg/m2 d1，29 or d1, 29, 57, 85. 5-Fu：750mg/m2 CIV24h d1-4，d29-32 or d1-4，d29-32, d57-60, d85-88.
~Radiation: Radiotherapy concurrent radiotherapy：IMRT radiotherapy 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity"
15988807|NCT02972372|Procedure|surgery|The patients randomized to receive either standard esophagectomy will have the operation performed in an open manner with two-field lymphadenectomy
15988808|NCT02972359|Drug|Neridronic acid|Neridronic acid administered as intravenous infusion.
15988809|NCT02972346|Drug|ACTH|routine treatment plus ACTH 0.4 Unit/kg/day (Maximum 25Unit) for three consecutive days every 4 weeks
15988810|NCT02972333|Drug|AZD9291 80mg oral each day|All eligible patients will have access to AZD9291 regimen through the ASTRIS study as long as they continue to show clinical benefit.
15988811|NCT02972333|Radiation|Radiation therapy|Radiation therapy will be implemented according to investigator's clinical practice.Based on the guidelines provided for the interruption of ADZ9291 with brain radiation therapy, a 7-10 days washout period before radiotherapy and 1 week period after completion of brain radiothearpy before re-starting AZD9291.
15988812|NCT02972320|Drug|temozolomide|temozolomide maintain therapeutic
15988813|NCT02972307|Other|wheelchair skills|the extent to which caregivers enhance the wheelchair skills of powered wheelchair users
15989049|NCT02970500|Drug|Methylphenidate HCl 10Mg SR|Methylphenidate HCl 10Mg SR (Phase 1) and Methylphenidate HCl 20Mg SR (Phase 2)
15988814|NCT02972294|Drug|Iron Isomaltoside 1000|Iron Isomaltoside 1000 will be use. Blinding procedure will be put in place for the administration of the treatment
15988815|NCT02972294|Drug|Tranexamic Acid|Tranexamic acid will be use.
15988816|NCT02972294|Drug|Placebos iron isomaltoside 1000|placebo of Iron Isomaltoside 1000 correspond to a saline solution. Blinding procedure will be put in place for the administration of this treatment
15988817|NCT02972294|Drug|Placebos tranexamic acid|placebo of tranexamic acid correspond to a saline solution.
15988818|NCT02972281|Biological|Immunological diagnosis tests|(Non exhaustive list): hemogram, IgG, A, M, IgG subclasses, complement, vaccinal response to protein and polysaccharide antigens, ...
15988819|NCT02972268|Drug|Tamsulosin 0.2mg + Solifenacin 5mg|Tamsulosin 0.2mg + Solifenacin 5mg for 12wks
15988820|NCT02972268|Drug|Tamsulosin 0.2mg + Placebo(Solifenacin)|Tamsulosin 0.2mg + Placebo(Solifenacin) for 12wks
15988821|NCT02972255|Drug|RO7079901|RO7079901 will be administered as per schedule described in individual arm.
15988822|NCT02972255|Drug|Meropenem|Meropenem will be administered as per schedule described in individual arm.
15988823|NCT02972255|Other|RO7049389 Placebo|Placebo matching to RO7049389 will be administered as per schedule described in individual arm.
15988824|NCT02972255|Other|Meropenem Placebo|Placebo matching to meropenem will be administered as per schedule described in individual arm.
15988825|NCT02972242|Radiation|Field of View|Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography
15988826|NCT02972229|Radiation|10x(3-5) Gy IMRT|10x(3-5) Gy IMRT on partial vertebral body for spinal metastases
15988827|NCT02972229|Radiation|10x3 Gy IMRT|10x3 Gy IMRT on whole vertebral body for spinal metastases
15988828|NCT02972216|Drug|Nolbaxol|
15988829|NCT02972216|Drug|Taxotere|
15988830|NCT02972216|Drug|cisplatin|
15988831|NCT02972203|Behavioral|Mindfulness Training for Primary Care|• MPTC is a primary care adaptation that includes core common Mindfulness-Based Intervention (MBI) elements. MTPC is a referral-based, insurance-reimbursable 8-week group psychotherapy delivered primarily by Patient-Centered Medical Home-integrated behavioral clinicians. MTPC groups are 2 hours long for 8 weeks, with a 7-hour day of silent group practice on a weekend. MTPC also emphasizes psychoeducational skills for self-regulation including a collaborative primary care provider (PCP) action-planning appointment during week 6.
15988832|NCT02972203|Behavioral|Mindfulness Intro. +resources +waitlist|Control arm: Participants receive a 60-minute introduction to mindfulness group plus referral to a list of community mindfulness resources such as private-pay community mindfulness classes, mobile mindfulness applications, books, and online recordings. These participants are added to a 6-month waitlist for a Cambridge Health Alliance mindfulness-based intervention group. All participants are scheduled to meet with their primary care provider during week 6 for a collaborative action planning visit.
15988833|NCT02972190|Procedure|Bilateral decompression with TLIF|Bilateral decompression of neural elements combined with TLIF
15988834|NCT02972190|Procedure|laminectomy with PLIF|Decompression of neural elements using laminectomy combined with PLIF
15988835|NCT02972190|Device|Pedicle screw and interbody cage|Pedicle screw and interbody cage
15988836|NCT02972177|Procedure|Radiofrequency ablation|Transbronchial radiofrequency ablation will be performed under the guidance of navigation bronchoscopy.
15988837|NCT02972177|Procedure|Microwave ablation|Transbronchial microwave ablation will be performed under the guidance of navigation bronchoscopy.
15988838|NCT02972164|Behavioral|Weight loss program for school children|"The intervention involves developing social and emotional competences, promotion of healthy lifestyle, use of activity monitoring devices to promote increased activity and enlisting family to maintain weight loss in the long term.
~The intervention group receives all program components: 1. Parent information sessions and orientation, 2. Two week intensive weight loss and lifestyle education camp, 3. after school clubs for consolidation (including physical activity and lifestyle education), and 4. wearable sensors and social media modules with parental involvement. Assessed outcomes include pre- and post-measurement at each phase included: weight, height, BMI, waist circumference, blood pressure, physical activity, dietary intakes, self-esteem, and subjective well-being."
15988839|NCT02972151|Drug|Comprehensive treatment of TCM|Subjects were treated with comprehensive treatment of TCM including Oral medicine: 1 dose daily by our hospital pharmacy medicine room Decoction decoction, each agent 200ml, and the 2 ton service. 10 days for a course of treatment, continuous treatment of 3 courses; retention enema with traditional Chinese medicine oral drugs according to different types of concentrated decoction enema, each dose of medicine decocting 2 times, 2 days of external application of Chinese medicine: Chinese medicine enema; break into powder, into the bag, steam for 45 minutes, and so the temperature dropped to appropriate, will be installed a Chinese medicine bag used on patients with lower abdomen for 20 minutes. Above method, a course of treatment for 10 days, continuous treatment of 3 courses.
15988840|NCT02972151|Other|Expectant treatment|Expectant treatment group patients were not treated during the observation period.（3 months after the start of the trial and 1 months after the end of the trial.）From the point of view of medical ethics, the expectant treatment group of patients at the end of the observation period, given the treatment of traditional Chinese medicine treatment group.
15988841|NCT02972125|Drug|Lacosamide (LCM) tablet|Treatment A: Single dose of Lacosamide (LCM) 100 mg tablet
15988842|NCT02972125|Drug|Lacosamide (LCM) dry syrup|Treatment B: Single dose of Lacosamide (LCM) 100 mg given as dry syrup
15988843|NCT02972112|Behavioral|CBT|novel cognitive behavioral protocol for the treatment of tokophobia
15988844|NCT02972112|Other|Sham|standard birth preparation sessions.
15988845|NCT02972099|Device|TcPRF|Transcutaneous Pulsed Radiofrequency is a method that is widely used for control of pain. There are no known complications. In this study a Radiofrequency generator will be used that has a separate outlet for transcutaneous use. It is used in the daily clinical practice in the Pain Center of the Swiss Paraplegic Center.
15988846|NCT02972099|Device|Placebo|In the Placebo Treatment, no current will be delivered. Since no sensations are produced by TcPRF treatment the patients won't recognize the difference.
15988847|NCT02972086|Behavioral|Behavioral Parent Training (BPT)|A specific intervention modality that has been shown to improve key functional outcomes in youth with ADHD.
15988848|NCT02972073|Other|Exercise intervention|Physical therapist will provide exercise for patients with low back pain for 60 minutes per day, 2-3 days per week for the total of 8 weeks.
15988849|NCT02972060|Drug|ODM-201|ODM-201 is a novel, oral, potent nonsteroidal AR inhibitor. ODM 201 will be administered as oral 300-mg tablets. The dose of study drug to be administered is 600 mg (2 x 300-mg tablets) b.i.d. to a daily dose of 1200 mg. It is recommended that ODM-201 be taken with food. Treatment should be initiated within 28 days from randomization.
15988850|NCT02972060|Drug|ADT|"ADT by means of LHRH antagonist for 24 weeks or by LHRH agonist therapy for 24 weeks with 4 weeks of anti-androgen to prevent flare.
~This includes leuprolide, goserelin, triptorelin, and degarelix. Beyond week 24, the treatment will be left to the discretion of the treating physician."
15988851|NCT02972047|Behavioral|Diaphragmatic Breathing|Subjects in this are practice diaphragmatic breathing for 30 minutes after each meal.
15988852|NCT02972047|Behavioral|Sham Comparator|Sham therapy (listening to music/watching TV for 30 minutes after each meal
15988853|NCT02972034|Drug|MK-8353|PO capsule
15988854|NCT02972034|Biological|Pembrolizumab|IV infusion
15988855|NCT02972021|Device|High-flow nasal cannula|
15988856|NCT02971995|Device|PET Scan ou TEP-TDM|Performance of the PET/CT using Flurocholine in order to detect the localization of the pathological fixation of the tracer and to determine the place where to take the biopsy
15988857|NCT02971995|Device|mpMRI|Performance of the mpMRI in order to determine the place where to take the biopsy
15988858|NCT02971982|Drug|rituximab /Dexamethasone/cyclophosphamide|rituximab:375mg/m2 ,Dexamethasone 20mg q12h,cyclophosphamide 750mg
15988859|NCT02971982|Drug|Velcade/Dexamethasone/cyclophosphamide|Velcade:1.3mg/m2,Dexamethasone 10mg q12h,cyclophosphamide 750mg
15988861|NCT02971943|Procedure|internal fixation for ankle fractures|The patients with ankle injury underwent internal fixation for ankle fractures and ligament repair. Ankle was observed with X-ray and magnetic resonance imaging.
15988862|NCT02971930|Biological|BAY94-9027|Intravenous infusion of BAY94-9027
15988863|NCT02971917|Radiation|Chest x-ray image acquisition|Obtain a digital X-ray chest image of the patient
15988864|NCT02971917|Radiation|Creation of TRUVIEW ART applied image|"Application of TRUVIEW ART to the original chest x-ray image to create a new set of TRUVIEW ART applied image.
~Outcome: 2 versions of chest image
~Original Chest X-ray (w/o TRUVIEW ART)
~TRUVIEW ART applied image"
15988865|NCT02971917|Radiation|Comparison of TRUVIEW ART image with original image|Comparison of 2 versions of chest image side by side Performance evaluation may consist of detailed categories such as expression of chest structure, visibility level of pulmonary vascular system, etc. For all categories visibility and preference will be scored and each category will be analyzed to point out any statistical difference
15988866|NCT02971904|Other|human milk collection|
15988867|NCT02971891|Drug|CLS006 (Furosemide) Topical Gel|
15988868|NCT02971891|Drug|Vehicle Topical Gel|
15988869|NCT02971878|Biological|Acetyl-L-carnitine (ALC), N-acetyl-L-cysteine (NAC) and α-lipoic acid (ALA)|Human embryos will be cultured in media that contains 3 antioxidants (Acetyl-L-carnitine (ALC), N-acetyl-L-cysteine (NAC) and α-lipoic acid (ALA)) that can be found in the in vivo Environment.
15988870|NCT02971865|Behavioral|CBT/CMT|Cognitive Behavioral Therapy (CBT - training to change nutritional thoughts and behaviors) and Chiropractic Manipulative Therapy (CMT - High Velocity, low amplitude chiropractic manipulation) were delivered in average total 8 visits in a year. The interventions were comparable in format (individual visit), duration (30 minute visits), frequency (monthly), and number of participants per group (see intervention details). Each intervention was delivered according to a protocol in which all instructors were trained. (Figure 3: Chiropractic/Behavioral health and Primary care Integration Protocol.) Routine care varied with patient complaints at the time of visit.
15988871|NCT02971865|Other|Control group traditional primary care|No change in care usually given
15988872|NCT02971839|Drug|VX-561|
15988873|NCT02971839|Drug|Placebo|
15988874|NCT02971839|Drug|IVA|
15988875|NCT02971826|Device|REVIVETM SE thrombectomy|Mechanical thrombectomy using the REVIVETM SE device in patient with an ischemic stroke due to an intracranial arterial occlusion
15988876|NCT02971813|Behavioral|Facebook|"Volunteers will be recruited during inpatient stay, or via phone call or in person after discharge and prior to beginning cardiac rehabilitation.
~Participants will be given a baseline BREQ-3 survey and a PNSE scale.
~Patients will be randomized to Facebook™ versus comparison groups using a blocked randomization.
~The Facebook™ intervention will include peer support, education, provider support and text message prompts when new posts are added.
~Educational posts will cover topics that will cover healthcare information.
~Provider support will be posted much like the educational posts.
~The data collection for this study will take place prior to beginning cardiac rehabilitation, at which time the participants will receive the BREQ-3 and PNSE surveys either in person or via email link.
~Post-testing will include a BREQ-3 and PNSE surveys and count of the number of sessions completed in a 3 month period of time."
15988877|NCT02971800|Drug|sodium fluorescein injection 10%|
15988878|NCT02971787|Dietary Supplement|Probiotics|Day 1-21: 2 capsules per day
15988879|NCT02971787|Dietary Supplement|Salt|Day 8-21: 10 tablets à 600 mg per day
15988880|NCT02971761|Drug|Enobosarm|Given PO
15988881|NCT02971761|Other|Laboratory Biomarker Analysis|Correlative studies
15988882|NCT02971761|Biological|Pembrolizumab|Given IV
15988883|NCT02971748|Biological|Pembrolizumab|Given IV
15988884|NCT02971735|Other|mobile technology of e-learning (M-TEL)|UME students learn the Top 10 emergent ORL-HNS disorders using the M-TEL including the IM module or the PPS module.
15988885|NCT02971722|Drug|JY09|2mg/1ml/bottle
15988886|NCT02971722|Drug|Placebo|1ml/bottle
15988887|NCT02971709|Behavioral|Shade Sail|Shade sails had powder-coated or gout galvanized steel poles and a lighter colored shade cloth to transmit visual light. The shade cloth met Ultraviolet Protection Factor (UPF) ratings to reduce UV under the shade cloth by 94%. The final shade sail designs and sizes were determined with input from parks department staff and complied with all local engineering, building, and planning codes. Shade sails exceeded the minimum safety requirements for strength (for wind and snow load), resistance to light degradation, and UV transmission. The design minimized climbing access points and hazards to adjacent activities.
15989045|NCT02970539|Drug|Oraxol|Oraxol (Paclitaxel and HM30181A) will be dosed orally. Paclitaxel will be supplied as capsules and HM30181A will be supplied as tablets.
15988888|NCT02971696|Drug|Sorafenib|Sorafenib will be administrated at a dose of 400 mg twice daily (consisting of two 200-mg tablets).Treatment interruptions and up to two dose reductions (first to 400 mg once daily and then to 400 mg every 2 days) will permitted for drug- related adverse effects. If further dose reductions will required, patients will withdraw from the study
15988889|NCT02971696|Drug|Best Supportive care|Liver Support, pain management
15988890|NCT02971683|Drug|Abatacept subcutaneous|Specified dose of Abatacept subcutaneous on specified days
15988891|NCT02971683|Drug|Placebo|Placebo of Abatacept subcutaneous
15988892|NCT02971670|Biological|rTSST-1 Variant Candidate Vaccine|Immunization either according to their former allocated dose (group 4: 3 µg of candidate vaccine or placebo, group 5: 10 µg of candidate vaccine or placebo, group 6: 30 µg of candidate vaccine or placebo) or 3 µg of candidate vaccine or placebo (groups 1 - 3) from Phase I.
15988893|NCT02971644|Device|cobalt alloy pedicle screw implantation|The patients with severe kyphosis deformity undergo cobalt alloy pedicle screw implantation.
15988894|NCT02971631|Other|Exendin 9-39|Complete blockade of action of endogenous GLP-1 by Exendin 9-39. Defined as a physiological study, not a clinical trial as such (as advised by the UK MHRA).
15988895|NCT02971631|Other|Placebo|Infusion of 1% human albumin in normal saline
15988896|NCT02971605|Drug|Psilocybin|25 mg/70 kg Psilocybin
15988897|NCT02971592|Device|MDcure|reception of real working MDcure - device that does apply the electromagnetic field
15988898|NCT02971592|Other|Mock Device|reception of device that does not apply the electromagnetic field
15988899|NCT02971579|Procedure|ERCP|Endoscopic procedure used to manage biliary and pancreatic diseases
15988900|NCT02971553|Device|Upright Resuscitator with PEEP|
15988901|NCT02971553|Device|Upright Resuscitator|
15988902|NCT02971540|Drug|Metamizol|in group A patients will receive pre-emptive analgesia using intravenous infusion of metamizol in a single dose of 1-1,25 gram with following intravenous infusion of 5 grams per day.
15988903|NCT02971540|Drug|Tramadol|in group A patients will receive pre-emptive analgesia using intravenous infusion of tramadol in a single dose of 2 mg per hg of body weight with following intravenous infusion of 400 mg per day.
15988904|NCT02971540|Drug|Bupivacaine|patients in group BF will receive local wound infiltration with a solution of 0,2% bupivacaine in a volume of 10 ml per segment of vertrebral columne.
15988905|NCT02971540|Drug|Ropivacaine|patients in group RF will receive local wound infiltration with a solution of 0,2% ropivacaine in a volume of 10 ml per segment of vertrebral columne.
15988906|NCT02971540|Other|control group|patients will receive no pre-emptive analgesia. intraoperatively standard dose of fentanyl will be used.
15988907|NCT02971527|Device|Oste-scan 500A|The investigators will detect the same calcaneus of each subject by experimental ultrasound bone strength device. Experimental ultrasound bone strength device's model number is Oste-scan 500A and report number is Z-Y-2009-2014, Z-E-0530-2014(G).
15988908|NCT02971527|Device|SONOST3000|The investigators will detect the same calcaneus of each subject by control ultrasound bone strength device. Control ultrasound bone strength device's model number is SONOST3000.
15988909|NCT02971514|Behavioral|Flossing before Brushing|
15988910|NCT02971514|Behavioral|Brushing before Flossing|
15988911|NCT02971501|Biological|Bevacizumab|Given IV
15988912|NCT02971501|Other|Laboratory Biomarker Analysis|Correlative studies
15988913|NCT02971501|Drug|Osimertinib|Given PO
15988914|NCT02971488|Other|Screening for HCV in PWID and Linkage-To-Care|"Screening, diagnosis and treatment of HCV in PWID, will be part of a harm reduction strategy.
~Treatment of HCV infected PWID will be delivered in a multidisciplinary care setting with services to reduce the risk of reinfection and for management of the common social and psychiatric comorbidities in this population."
15988915|NCT02971475|Procedure|extracorporeal shock wave lithotripsy|People in this group would be treated with ESWL only.
15988916|NCT02971475|Procedure|endoscopic drainage of the main pancreatic duct|People in this group would be treated with ESWL followed be endoscopic drainage in 48 hours.
15988917|NCT02971475|Drug|Analgesics|Analgesics administrated include morphine, buprenorphine, pethidine, tramaldol, metamizole and acetylsalicylacid. They will only be administrated as needed.
15988918|NCT02971462|Device|ischemic conditioning|In this study, the remote ischemic conditioning treatment was composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which was induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation.
15988919|NCT02971449|Device|Amazon Fire Tablet|A generic amazon fire tablet with pre-loaded instructional videos
15988920|NCT02971449|Other|ICCM Traditional Trainins|Standard, Didactic VHT Training intervention as an active comparator
15988921|NCT02971436|Device|FPH Device with SensAwake On + Pressure Support A|FPH Device with SensAwake On + Pressure Support A
15988922|NCT02971436|Device|FPH Device with SensAwake Off + Pressure Support A|FPH Device with SensAwake Off + Pressure Support A
15988923|NCT02971436|Device|FPH Device with SensAwake On + Pressure Support B|FPH Device with SensAwake On + Pressure Support B
15988924|NCT02971436|Device|FPH Device with SensAwake Off + Pressure Support B|FPH Device with SensAwake Off + Pressure Support B
15988925|NCT02971436|Device|Competitor's PAP Released Device + Pressure Support A|Competitor's PAP Released Device + Pressure Support A
15988926|NCT02971436|Device|Competitor's PAP Released Device + Pressure Support B|Competitor's PAP Released Device + Pressure Support B
15988927|NCT02971423|Drug|ETX2514|
15988928|NCT02971423|Drug|Placebo|matching placebo infusion
15988929|NCT02971423|Drug|Sulbactam|
15988930|NCT02971423|Drug|Imipenem/Cilastatin|
15988931|NCT02971410|Other|Laboratory Biomarker Analysis|Correlative studies
15988932|NCT02971410|Other|Quality-of-Life Assessment|Ancillary studies
15988933|NCT02971410|Drug|Simvastatin|Given PO
15988934|NCT02971397|Procedure|Bone Marrow Aspiration and Biopsy|Undergo bone marrow aspiration and biopsy
15988935|NCT02971397|Drug|Cytarabine|Given IV
15988936|NCT02971397|Drug|Daunorubicin Hydrochloride|Given IV
15988937|NCT02971397|Other|Laboratory Biomarker Analysis|Correlative studies
15988938|NCT02971384|Drug|Echinaforce|
15989050|NCT02970500|Drug|Placebo Group|Placebo
15988939|NCT02971371|Device|Lokomat|"Both the groups performed 40 45min Lokomat sessions, five times a week, between 9am and 11am. The RAGTand VR group received a visual feedback showing a VR run game where the patient had to collect or avoid objects, to motivate him/her to walk actively. Each avatar's leg movement corresponded to that performed by the patient. On the other hand, the RAGT without VR group was not provided an avatar, and a smile indicating the goodness of each leg movement. The biofeedback of the Lokomat gait orthosis is based on the interaction torques between the participant and the orthosis"
15988940|NCT02971358|Procedure|Radical prostatectomy|Standard radical prostatectomy with extended lymph node dissection is performed.
15988941|NCT02971345|Procedure|Stent and Iodine-125 seed strand implantation|The patent second-order branch of the intrahepatic portal vein was punctured with a 22-gauge Chiba needle under ultrasound guidance.Stent and Iodine-125 seed strand are implanted by two 0.035-inch,150-cm-long wire.
15988942|NCT02971345|Device|Stent|Bare stent should be placed through a 7-F, 23-cm-long sheath over the wire.
15988943|NCT02971345|Device|Iodine-125 seed|The number of Iodine-125 seeds planned to be implanted was calculated by the following formula: N = length of obstructed main portal vein (mm)/4.5 + 4. These seeds were arranged linearly and sealed into a 4-F catheter continuously to construct a Iodine-125 seed strand.
15988944|NCT02971345|Drug|Epirubicin|Epirubicin is a chemotherapy drug used in transarterial chemoembolization (TACE).Dosage: Epirubicin 30-60 mg per patient,depending on the situation of the patient.
15988945|NCT02971345|Drug|Ultra-fluid lipiodol|Ultra-fluid lipiodol is a kind of embolization material used in TACE. Standard: 38% ultra-fluid lipiodol .
15988946|NCT02971345|Other|Gelatin sponge articles|Gelatin sponge articles embolization material used in TACE. Standard: 350-560 um in diameter.
15988947|NCT02971332|Procedure|Stapled Transanal Rectal Resection|"The prolapsed tissue is pulled out through the CAD using e gauze pad and Allis forceps; this allows us to identify the extent of the prolapse to be resected. Four to five parachute stitches are then apposed circumferentially, like parachute cords, at the apex of the prolapse, in order to control the tissue during resection. The prolapse is then opened longitudinally at 3 o'clock with the electric scalpel between two Kocher clamps. Two traction stitches are applied at the deep vertex of the prolapse, one for each Kocher apex.
~The longitudinal opening then allows the surgeon to begin circumferential resection of the rectum by pulling on the parachute stitches. This maneuver is performed counterclockwise using an average of 4-6 recharges, with care to always place the stapler at the base of the prolapse. The resected specimen was always inspected before the end of the procedure."
15988948|NCT02971319|Device|Tc-99M-Tetrofosmin SPECT|
15988949|NCT02971319|Device|F-18 FDG PET|
15988950|NCT02971306|Drug|standard medical therapy|Standard medical therapy involves primary treatment with pentoxifylline at a dose of 400 mg three times a day and normal hospital nutrition (1800 to 2000 kcal per day). Diuretics, sodium restriction and albumin for treatment of ascites or fresh frozen plasma for coagulopathy or antibiotics for any focus of infection as spontaneous bacterial peritonitis (SBP), pneumonia, cellulitis, and urinary tract infection as indicated.
15988951|NCT02971306|Drug|G-CSF|G-CSF- 5μg/Kg s.c every 12 hours for 5 consecutive days
15988952|NCT02971306|Drug|n-Acetylcysteine|n-Acetylcysteine at 150, 50, and 100 mg/kg in 250, 500, and 1000 ml of 5% glucose solution over 30 minutes, 4 hours, and 16 hours, respectively; days 2 through 5: 100 mg/kg/day in 1000 ml of 5% glucose solution
15988953|NCT02971293|Drug|AZD8871 100 µg|The subjects will receive one dose of AZD8871 100 µg single dose DPI.
15988954|NCT02971293|Drug|AZD8871 600 µg|The subjects will receive AZD8871, 600 µg single dose DPI.
15988955|NCT02971293|Drug|Placebo|The subject will receive Placebo single dose DPI.
15988956|NCT02971267|Other|Observational|None, observational only
15988957|NCT02971254|Drug|Sevoflurane|
15988958|NCT02971254|Drug|Desflurane|
15988959|NCT02971241|Behavioral|Intergenerational Mobile Technology Opportunities Program|The themes of the 8-week training session are designed based on the objectives of IMTOP: 1) teach skills of tablet use and diabetes self-management behavior tracking app, 2) introduce online community communication to decrease social isolation and obtain social support from family and friends, young volunteers, health care providers, and diabetes peers who have similar condition/interest/ or disease), 3) teach diabetes self-management knowledge and skills based on the evidence-based Chronic Disease Self-Management Program; and 4) teach mobile technology application to healthcare access and daily needs (i.e., online appointment, online refill, appointment reminder, online health information, online training videos, and virtual classes such as e-newspaper, e-books, related sites, apps).
15988960|NCT02971228|Drug|Insulin Lispro|Used to lower blood glucose. Commercially available by prescription and is indicated for patients with type 1 diabetes mellitus (T1DM), but not for use in a bionic pancreas. Individualized dose based on metabolic needs and frequent monitoring of blood glucose.
15988961|NCT02971228|Drug|ZP4207 (dasiglucagon)|A glucagon analog not yet approved by the FDA. Subcutaneous administration in one BP arm.
15988962|NCT02971228|Drug|Glucagon|A hormone normally made by the pancreas to raise blood glucose. Used to treat low blood sugar. Commercially available by prescription and is indicated for patients with T1DM in severe hypoglycemia, but not for use in a BP. Subcutaneous administration in one BP arm.
15988963|NCT02971228|Device|iPhone-based bionic pancreas|An experimental device.
15988964|NCT02971228|Device|iLet-based bionic pancreas|An experimental device.
15988965|NCT02971215|Device|iLux Laser|"Treatment during 15 sessions. It is divided in two phases: 1. 12W. 50 Hz 20% duty cycle. 50 J/cm² in painful zone. 2. 15 W. Burst (10 pulses-900 msec each train) 250 J/cm² in painful zone. Trough the iLux Laser (Mectronic Medicale, Italy)
~+ Physical Therapy protocol."
15988966|NCT02971215|Device|Sham ilux Laser|Sham treatment during 15 sessions trough the iLux Laser (Mectronic Medicale, Italy), It is applies the same time than experimental one but with 0 W + Physical Therapy protocol.
15988967|NCT02971202|Drug|Hyperinsulinemic, euglycemic clamp|"Participants will undergo an 8-hour hyperinsulinemic, euglycemic clamp to quantify insulin sensitivity at whole-body and tissue-specific levels. The following hormones will be infused in the study:
~insulin (12 mU/m^2/min [3x basal] for 150 minutes, then 40 mU/m^2/min [10x basal] for 180 minutes)
~glucagon (0.65 ng/kg/min [1x basal] for 330 minutes)
~somatostatin (60 ng/kg/min) These infusions will maintain a basal glucagon level and an increased insulin level in the blood that will be equal between all 3 cohorts."
15989202|NCT02969382|Drug|SEP-363856|One SEP-363856 capsule (50 mg or 75 mg) daily for four weeks
15988968|NCT02971202|Drug|20% dextrose|A variable infusion of 20% dextrose will be used to maintain plasma glucose within the euglycemic range throughout the hyperinsulinemic portion of the clamp. 6,6-H2 glucose will be infused at a low rate (0.033-0.22 µmol/kg/min) to determine glucose flux during the study.
15988969|NCT02971189|Device|Librata Endometrial Ablation|The treatment procedure will be performed in accordance with the physician's routine endometrial ablation practice and in accordance with the requirements of the LibrataTM IFU. The uterine cavity will be systematically inspected using hysteroscopy prior the ablative procedure (after any blind cervical dilatation) and post the ablative procedure to estimate the completeness of endometrial destruction and to exclude uterine trauma including uterine perforation. The patient will undergo standard post-operative monitoring and recovery according to usual hospital practices. An assessment will be made for any ablation procedure or device related serious adverse events.
15988970|NCT02971176|Radiation|Low-dose protocol computed tomography|Radiation dose under the low-dose protocol computed tomography (120 kilovolt, 15 milliampere seconds)
15988971|NCT02971176|Radiation|Standard-dose protocol computed tomography|Radiation dose under the standard-dose protocol computed tomography (120 kilovolt, 150 milliampere seconds)
15988972|NCT02971163|Behavioral|SynDA|SynDA is a paper-based, personalized decision aid which gives information to patients about their medical condition (i.e. syncope), future risk, and options for care. It is written in lay language and aims to create an informed conversation between a patient and their ED provider.
15988973|NCT02971150|Behavioral|Brief Behavioral Treatment for Insomnia|
15988974|NCT02971137|Behavioral|Smoking Cessation plus CBI|proactive tele-health intervention combining evidence-based smoking cessation counseling augmented with behavioral approaches for coping with pain
15988975|NCT02971137|Behavioral|Smoking Cessation Standard|standard telephone-based smoking cessation intervention
15988976|NCT02971098|Procedure|Reduced activity|Participants will reduced their physical activity level to approximately 2000 steps or 75% of their normal activity levels.
15988977|NCT02971085|Procedure|Active surveillance|Active surveillance cohorts are routinely performed the systematic biopsy ≥ 12 cores by TRUS-guided or MR-TRUS fusion according to the protocol based by time path as 1, 2, 4, 7, 10 years and subsequently every 5 years following initial TRUS biopsy.
15988978|NCT02971072|Procedure|Subacromial injection|A subacromial injection consisting up 6 cc 0.5% Marcaine with Epinephrine and 1 cc DepoMedrol will be administered.
15988979|NCT02971072|Other|Physical Therapy|A standardized six-week exercise protocol supervised by a physical therapist
15988980|NCT02971059|Dietary Supplement|Phenylalanine intake|Phenylalanine will be provided as graded intakes ranging from 7-40 mg/kg/day
15988982|NCT02971033|Drug|20mg ezetimibe|Participants assigned to this intervention will receive 20mg per day of ezetimibe for 12 weeks.
15988983|NCT02971033|Drug|Placebo|Participants assigned to this intervention will receive placebo every day for 12 weeks
15988984|NCT02971033|Drug|40mg ezetimibe|Participants assigned to this intervention will receive 40mg per day of ezetimibe for 12 weeks.
15988985|NCT02971020|Other|Observational/Cognitive Assessment|Montreal Cognitive Assessment (MoCA); Trail Making Test Part A; Trail Making Test Part B; Phonemic Fluency (letter fluency) and Semantic Fluency (category).
15988986|NCT02971007|Drug|Oral Encochleated Amphotericin B (CAMB)|lipid-crystal nano-particle formulation amphotericin B
15988987|NCT02971007|Drug|Fluconazole|
15988988|NCT02970981|Biological|Nivolumab|
15988989|NCT02970981|Biological|Ipilimumab|
15988990|NCT02970968|Drug|VLY-686 (Tradipitant)|oral capsule
15988991|NCT02970968|Other|Placebo|placebo oral
15988992|NCT02970955|Procedure|Inoperable thoracic nodes metastases|The radiation treatment will be delivered with three possible schedules, with a risk adaptive scheme according to number, site and size of metastatic nodes and based on the possibility to respect the constraints of healthy tissues
15988993|NCT02970942|Drug|Semaglutide|Once daily administration of semaglutide subcutaneously (s.c., under the skin) in three different doses (0.1 mg, 0.2 mg and 0.4 mg)
15988994|NCT02970942|Drug|Placebo|Once daily administration subcutaneously ( s.c., under the skin)
15988995|NCT02970929|Drug|SEP-363856|One SEP-363856 capsule (25 mg, 50 mg or 75 mg (flex)) daily for 26 weeks
15988996|NCT02970916|Drug|FOLFIRI+aflibercept|"Aflibercept: 4 mg/kg administered intravenous infusion on day 1
~FOLFIRI regimen immediately after aflibercept:
~Irinotecan:180 mg/m2 intravenous infusion, folinic acid (dl racemic): 400 mg/m2 intravenous infusion, followed by 5-fluorouracil (5-FU): 400 mg/m2 intravenous bolus, followed by 5-FU: 2400 mg/m2 continuous intravenous infusion over 46 hours.
~* folinic acid: 400 mg/m² (racémic) or 200 mg/m² (L-form)"
15988997|NCT02970903|Device|VitalPAD|VitalPAD prototype device
15988998|NCT02970903|Device|Traditional tools|Paper based records, screenshots of monitors and therapy devices
15988999|NCT02970890|Device|Portable Pain Away™|Portable Pain Away™ device (manufactured by Multi Radiance Medical, Solon - OH, USA) - placebo or active phototherapy
15989000|NCT02970877|Biological|Fecal filtrate from 150 g stool from healthy lean donors|150 g stool from healthy lean donors will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.
15989001|NCT02970877|Biological|Fecal filtrate from 150 g of the recipient's own stool|150 g stool from the recipient will be diluted in 0.9% normal saline to a total volume of 450 mL. Preparation from frozen stool.
15989002|NCT02970864|Device|Polynerve|Polymer biomaterial nerve conduit
15989046|NCT02970539|Drug|Ramucirumab|Ramucirumab will be administered by iv infusion and supplied as a solution at a concentration of 10 mg/mL
15989047|NCT02970526|Drug|Oxaliplatin|Intensity of neuropathy induced by oxaliplatin evaluated by the QLQ-CIPN20 Questionnaire (EORTC).
15989048|NCT02970513|Other|Psychiatric evaluation|The purpose of this study is to determine whether the presence of pathogenic Escherichia coli in colon is associated with psychiatric disorders.
15989203|NCT02969382|Drug|Placebo - Cap|One Placebo capsule daily for 4 weeks
15989003|NCT02970838|Other|Structured weight-loss program|"During the fasting phase, daily consumption consists of five sachets fully replacing normal food and corresponded to an energy content of 800 kcal. This fasting phase is followed by a four-week refeeding phase, during which regular food will be reintroduced and formula diet is gradually replaced until a daily total intake of 1200 kcal is reached. During the last five weeks of the program, energy intake is gradually increased to an individual level between 1200 kcal and 1500 kcal that allowed subjects to keep their weight stable.
~Once a week participants visit the study center to monitor health status and taking part in supervised exercises and a nutritional and behavioral counseling."
15989004|NCT02970825|Other|Exercise|Moderate to high intensity physical training
15989005|NCT02970825|Other|Relaxation|Low intensity physical activity and relaxation
15989006|NCT02970812|Device|Electrical Muscle Stimulation|Participants were under EMS 5 times a week for 12 weeks. Pads were applied on participants' abdomen, rectus abdominis and external oblique abdominal muscle areas without any recent wound, infection, scar, and warts while lie on their back.
15989007|NCT02970812|Device|Transcutaneous Electrical Nerve Stimulation|Participants were under TENS 5 times a week for 12 weeks. Pads were applied on participants' abdomen, rectus abdominis and external oblique abdominal muscle areas without any recent wound, infection, scar, and warts while lie on their back.
15989008|NCT02970786|Drug|Injection of 68Ga-NODAGA-E(c[RGDyK])2|Following one injection of 68Ga-NODAGA-E(c[RGDyK])2 the patients will be PET scanned at 10 minutes, 1 hour and 2 hours post injection
15989009|NCT02970773|Drug|Rivaroxaban Oral Tablet|oral application of Xarelto
15989010|NCT02970747|Drug|Carfilzomib|In accordance with SmPC.
15989011|NCT02970734|Behavioral|Breathe|Six web-based cognitive behavioural therapy sessions. Telephone and email support are also provided during the program.
15989012|NCT02970734|Behavioral|Resource Webpage|Static webpage listing anxiety resources.
15989013|NCT02970721|Drug|Antipsychotic|Antipsychotic monotherapy
15989014|NCT02970721|Drug|Antidepressant|Antidepressant monotherapy
15989015|NCT02970721|Drug|Antipsychotic and Antidepressant|Polytherapy
15989016|NCT02970708|Device|EFG group|88 anisometropic amblyopia will be recruited to receive Eyetronix Flicker Glasses treatment.
15989017|NCT02970708|Device|Patching group|88 anisometropic amblyopia will be recruited to receive patching treatment.
15989018|NCT02970695|Device|magneto-auriculotherapy (MAT)|Subjects will then receive MAT. The magnetic pellets will have ~200 gauss/pellet magnetic flux densities on average, with a diameter of 1.76 mm.The experimental object will be applied to the seven selected acupoints as detected by an acupoint detector. Only one ear will receive treatment at a time, and the pellets will remain in situ for two days before the next change.
15989019|NCT02970695|Device|Laser auriculotherapy (LAT)|A laser device (Pointer Pulse™)15 will be used in this study. This device has a wavelength of 650 nm, an average output power of 2.5 mW, an energy density of 1 minute with 0.54 J/cm,2 and a pulse of 10 Hz, which is a common acceptable dosage for clinical use. 16, 17 This application is a low-energy laser therapy (LLLT), in which the energy level emitted from the device is approximately comparable to a teaching pointer. A 1-minute treatment using the continuous mode of the device will be directly applied to the selected acupoints. Laser protective goggles will be provided to the subjects and the researcher for eyes protection
15989020|NCT02970682|Drug|SFX-01|Stabilised Sulforaphane
15989021|NCT02970682|Drug|Fulvestrant|Fulvestrant
15989022|NCT02970682|Drug|Tamoxifen|Tamoxifen
15989023|NCT02970682|Drug|Aromatase Inhibitors|
15989024|NCT02970669|Drug|sacubitril/valsartan (LCZ696)|sacubitril/valsartan tablet taken orally.
15989025|NCT02970669|Drug|enalapril|Enalapril tablet taken orally.
15989026|NCT02970669|Drug|matching placebo sacubitril/valsartan (LCZ696)|matching placebo sacubitril/valsartan tablet taken orally
15989027|NCT02970669|Drug|matching placebo enalapril|matching placebo enalapril tablet taken orally
15989028|NCT02970656|Behavioral|Teens.Connect|Teens.Connect combines two internet psycho-educational programs, TEENCOPE™, an internet version of coping skills training using a graphic novel format combined with social media, and an internet diabetes problem-solving educational program (Managing Diabetes)
15989029|NCT02970643|Drug|Olanzapine|Moderate risk chemotherapy induced nausea group in all cancer. D1 Olanzapine 10mg PO D2-3 Olanzapine 10mg PO
15989030|NCT02970643|Drug|Palonosetron|Moderate risk chemotherapy induced nausea group in all cancer. D1 Palonosetron 0.25mg IV
15989031|NCT02970630|Drug|Tacrolimus|once a day
15989032|NCT02970630|Drug|Everolimus|twice daily
15989033|NCT02970617|Other|Memory Intervention|Ring bell after final radiation treatment
15989034|NCT02970617|Other|Questionnaire Administration|Ancillary studies
15989035|NCT02970617|Radiation|Radiation therapy|Radiation therapy with or without chemotherapy
15989036|NCT02970604|Drug|Aspirin|Non enteric coated aspirin
15989037|NCT02970591|Other|Traditional dietary advice and low FODMAP content|Traditional dietary advice according to the Brittish Dietetic Association including reducing the intake of fermentable carbohydrates.
15989038|NCT02970591|Other|Low carbohydrate diet|Diet that contains a maximum of 10 energy percent of carbohydrates, 25 energy % proteins and 65 energy % fat.
15989039|NCT02970591|Other|Optimized Medical treatment|Standard consultation by physician and if needed patients will receive medical treatment based on the most prominent symptom. Constipation: osmotic laxatives, linaclotide. Diarrhea: loperamid, bile acid binders. Pain: anti depressent, antispasmodics, linaclotide.
15989040|NCT02970578|Procedure|3D printed module|The patients underwent 3D printed module-assisted lumbar pedicle screw placement using the Quandrant system, aiming to restore the stability of the spine.
15989041|NCT02970565|Behavioral|Family Nurture Intervention|The mother-child pair will be asked to talk and play with each other as they customarily do. If the child becomes restless and dysregulated the mother will be coached by the Nurture Specialist to bring the child back into a calm state through sustained physical contact, comfort touch, soothing words, and eye contact.
15989042|NCT02970565|Behavioral|Nutrition and Play Intervention|Mothers and children in the Play and Nutrition group will play educational and nutrition-focused games.
15989043|NCT02970552|Drug|Vaginal Progesterone|200 mg micronized vaginal progesterone suppository
15989044|NCT02970552|Drug|Placebo|Indistinguishable placebo vaginal suppository
15989051|NCT02970487|Device|Intraocular implant of the Precisight|Precisight ismplanted in place of the natural cloudy lens, inside the capsular bag.
15989052|NCT02970474|Device|Conventional Bolus|Conventional bolus is mold made from Super stuff powder, superflab, or paraffin wax and made to fit the contours of the body.
15989053|NCT02970474|Device|3D Printed Bolus|The 3D printed bolus is also made from Super stuff powder, superflab, or paraffin wax, however it uses CT scans to print a molded bolus from the images of the participant's body.
15989054|NCT02970461|Other|Gamified Group|See Gamified Group in Arms description.
15989055|NCT02970461|Other|Control Group|See Control Group in Arms description.
15989056|NCT02970448|Procedure|LITT|MRI-guided laser interstitial thermal therapy uses a gas cooled side-firing (directional) laser and a variety of procedure specific tools to thermally ablate target tissue in-situ.
15989057|NCT02970448|Radiation|Radiation therapy|One treatment of 2 Gy will be given daily 5 days per week for a total of 60 Gy over 6 weeks. All portals shall be treated during each treatment session. Doses are specified such that at least 95% of the planning target volume (PTV) shall receive 100% of the prescribed dose.
15989058|NCT02970448|Drug|Temozolomide|Temozolomide will be administered continuously from day 1 of radiotherapy to the last day of radiation at a daily oral dose of 75 mg/m2 for a maximum of 49 days
15989059|NCT02970435|Behavioral|Video Discharge Instructions|The video discharge instructions, will be provided to the patient at the time of surgical procedure.
15989060|NCT02970435|Behavioral|Telecommunication Reminders|Telecommunication reminders including text messages, email, or phone calls to remind participants how to access the video discharge instruction up to three times before follow-up
15989061|NCT02970435|Behavioral|Standard of Care|Standard of Care: verbal and written discharge instructions for patients after surgery
15989062|NCT02970422|Other|Patient Survey|Participants will answer an online survey and their medical chart information will be gathered to compare responses across disease severity.
15989063|NCT02970409|Device|saline|catheter lock using saline
15989064|NCT02970409|Device|Heparin|catheter lock using Heparin
15989065|NCT02970396|Behavioral|self-management|
15989066|NCT02970383|Behavioral|Initial prescription for 10 narcotic tabs|Reduced number of pills in initial prescription post-operatively
15989067|NCT02970383|Behavioral|Inital prescription for 30 narcotic tabs|
15989068|NCT02970370|Other|no intervention|
15989069|NCT02970357|Other|DIAPASON Questionnaire|"50 item questionnaire of the French Youth Diabetes Association to evaluate one's theoretical knowledge about the diabetes disease. 6 main themes are evaluated :
~what is diabetes
~Monitoring
~Hypoglycemia and Hyperglycemia
~Nutrition
~Insuline"
15989070|NCT02970357|Behavioral|WHO-5|5 item questionnaire of the World Health Organization about quality of life
15989071|NCT02970344|Behavioral|Diabetes Coping Skills Training (DCST)|Diabetes Coping Skills Training (DCST) consist of twelve 50 minutes sessions delivered over 6 months using a faded contact model ( 6 weekly session, 3 biweekly sessions and 3 monthly sessions)
15989072|NCT02970331|Drug|pefcalcitol ointment, 0.005%|pefcalcitol ointment, 0.005%
15989073|NCT02970318|Drug|Acalabrutinib (ACP-196)|Acalabrutinib monotherapy
15989074|NCT02970318|Drug|Rituximab|Rituximab in combination with idelalisib or bendamustine
15989075|NCT02970318|Drug|Idelalisib|Idelalisib in combination with rituximab
15989076|NCT02970318|Drug|Bendamustine|Bendamustine in combination with rituximab
15989077|NCT02970305|Drug|Pimavanserin|Pimavanserin 34 mg, 20 mg, or 10 mg, taken as two tablets, once daily by mouth
15989078|NCT02970305|Drug|Placebo|Placebo, taken as two tablets, once daily by mouth
15989079|NCT02970292|Drug|Pimavanserin|Pimavanserin 34 mg, 20 mg, or 10 mg , taken as two tablets once daily by mouth
15989080|NCT02970292|Drug|Placebo|Placebo, taken as two tablets, once daily by mouth
15989081|NCT02970279|Behavioral|Behavioural Activation Group (BAG) Psychotherapy|Behavioural activation (BA) is a psychotherapy intervention based on behaviour theory and operant conditioning. It teaches patients to reduce avoidant depressive behaviours and in turn increase the positive reinforcement they receive from their environment for non-depressive behaviours through the use of activity scheduling and pleasant events. For the trial, BA will be delivered in a group format (BAG) and facilitated by two therapists. BAG treatment will consist of eight weekly sessions, lasting two hours and will follow a manualised treatment protocol. Each session will be based on a different topic relevant to the principles of BA and patients will be given between session work to complete to encourage increased participation in rewarding personally meaningful activities.
15989082|NCT02970253|Procedure|Capsular resection|Capsular resection
15989083|NCT02970253|Procedure|Capsular retention|Capsular retention
15989084|NCT02970240|Procedure|Cardiopulmonary testing|A 2-day consecutive testing on an ergometer cycle
15989085|NCT02970227|Other|Observation|None, observation only
15989086|NCT02970214|Other|no intervention, only observational|no intervention, only observational
15989087|NCT02970201|Other|EpxDialysis|The EpxDialysis intervention consists of automated SMS text or voice messages delivered to the patient's preferred phone number three times per week. These messages provide details about the subject's upcoming hemodialysis session, anticipatory guidance regarding clinically-concerning symptoms, as well as the option for direct call routing to the dialysis center for rescheduling sessions.
15989088|NCT02970188|Behavioral|Time Restricted Feeding|consuming all daily calories within an 8 hour feeding window
15989089|NCT02970175|Drug|Terlipressin administration|Patients undergoing a bronchoscopy under local anesthesia for biopsy sampling of endobronchial lesions. Bronchoscopy will be done with terlipressin administration
15989090|NCT02970175|Procedure|bronchoscopy under local anesthesia|Patients undergoing a bronchoscopy under local anesthesia for biopsy sampling of endobronchial lesions. Bronchoscopy will be done with terlipressin administration
15989091|NCT02970175|Procedure|Biopsy sampling|Patients undergoing a bronchoscopy under local anesthesia for biopsy sampling of endobronchial lesions. Bronchoscopy will be done with terlipressin administration
15989092|NCT02970162|Drug|Amifampridine Phosphate|
15989093|NCT02970162|Drug|Placebo Oral Tablet|
15989094|NCT02970149|Other|NA (observational)|
15989095|NCT02970136|Device|OraQuick Swab|OraQuick for oral fluid HIV antibody testing
15989204|NCT02969369|Drug|SEP-363856|SEP-363856 (25, 50, or 75mg/day)
15989096|NCT02970136|Device|Fecal Immunochemical Test|Fecal Immunochemical stool test specific for human hemoglobin
15989097|NCT02970136|Device|OraQuick Fingerstick|Patients will be tested for Hepatitis C infection using a fingerstick
15989098|NCT02970136|Other|Standard Screening Tests|Patients will be navigated to a local health center for standard screening tests
15989099|NCT02970136|Device|HPV Self-Sampling Test|Patients will be using swab to check for HPV infection
15989100|NCT02970136|Other|Home Based Screening Tests|Patients will provided screening tests and instructed by Community Health Worker on how to perform home screening tests
15989101|NCT02970123|Behavioral|Sit Less, Interact, Move More (SLIMM)|
15989102|NCT02970097|Drug|20ml bolus of 0.5% ropivicaine|local anesthetic
15989103|NCT02970097|Drug|10 ml of 0.5% ropivicaine|local anesthetic
15989104|NCT02970097|Drug|Midazolam|1-2 mg of medication given intravenously before nerve block
15989105|NCT02970097|Drug|Fentanyl|50-100 mcg of medication given intravenously before nerve block
15989106|NCT02970084|Other|Nutraceutical product based on vitamin K2 (PLAK2)|
15989107|NCT02970058|Other|Platelet-rich Plasma|The active group will receive Platelet-rich Plasma following spinal injection
15989108|NCT02970058|Other|Control|The control group will receive saline as a placebo
15989109|NCT02970045|Procedure|Biospecimen Collection|Undergo collection of blood, tissue, and other biological samples
15989110|NCT02970045|Procedure|Evaluation of Cancer Risk Factors|Ancillary studies
15989111|NCT02970045|Other|Medical Chart Review|Review of medical chart
15989112|NCT02970045|Other|Quality-of-Life Assessment|Ancillary studies
15989113|NCT02970045|Other|Questionnaire Administration|Ancillary studies
15989114|NCT02970032|Drug|Real time heparin dose adjustment|Patients will have steady state anti-Xa levels drawn at least 6 hours after initiation of heparin infusion. Patients with out of range anti-Xa levels will receive real time heparin dose adjustment followed by repeat anti-Xa levels.
15989115|NCT02970032|Drug|Standard heparin dose|Patients will be placed on heparin infusions per their surgeon's discretion.
15989116|NCT02970019|Drug|K0706|Once a day administration after fast
15989117|NCT02970019|Drug|Placebo|Once a day administration after fast
15989118|NCT02970006|Device|neurovisual stimulation|a new system of multisensory stimulation based on virtual and enhanced reality (i.e., neuro-visual stimulation)
15989119|NCT02969993|Other|Questionnaires|evaluating the voice outcome by the fullfilment of the voice handicap index
15989120|NCT02969980|Drug|Cyclophosphamide|Cyclophosphamide 50 mg/kg/day i.v. daily on days 3 and 4 of hematopoietic cell transplantation
15989121|NCT02969967|Device|SaeboFlex|Use of the SaeboFlex orthosis for a set protocol of grasp-release activities for 50 minutes at least 3 times per week, followed by 10 minutes of grasp-release activities without the orthosis for 8 weeks. Will occur in participants' homes after discharge from inpatient rehabilitation with visit from principal investigator to progress program for 1 hour 3 times a week for the first 2 weeks and then once a week for 6 weeks.
15989122|NCT02969954|Other|Self-efficacy for diabetes management|Participants at both sites will watch a 12 minute video featuring the digital stories on diabetes. Following the video, participants will engage in a brief facilitated discussion regarding motivations and barriers to diabetes management, led by a trained Spanish-speaking facilitator.
15989123|NCT02969941|Other|transcranial magnetic stimulation|The stimulations were performed by MagStim Rapid2.
15989124|NCT02969928|Procedure|Full-mouth ultrasonic debridement|Full-mouth ultrasonic debridement will be performed in order to treat diseased sites
15989125|NCT02969928|Drug|Clarithromycin|Administration of Clarithromycin 500mg bid for 7 days
15989126|NCT02969928|Drug|Amoxicillin|Administration of Amoxicillin 500mg tid for 7 days.
15989127|NCT02969928|Drug|Metronidazole|Administration of Metronidazole 400mg tid for 7 days.
15989128|NCT02969915|Behavioral|Incentives|Treatment incentives are offered to HIV-positive participants for reaching treatment targets, including retention to medical follow-up, initiating antiretroviral therapy, and maintaining high adherence with antiretroviral therapy.
15989129|NCT02969915|Behavioral|Integrated Care Centers|ICCs offer key-population-oriented, vertically-integrated harm reduction, HIV testing, and HIV treatment services
15989130|NCT02969902|Device|Buzzy® device|
15989131|NCT02969902|Device|Hand-held computer|
15989132|NCT02969889|Device|Airtraq|video laryngoscope with a channel
15989133|NCT02969889|Device|ILMA|
15989134|NCT02969876|Drug|Vortioxetine|Vortioxetine is a selective serotonin re-uptake inhibitor (SSRI), a common form of treatment for major depressive disorder.
15989135|NCT02969863|Device|Bihormonal Bionic Pancreas|Participants will wear a Bionic Pancreas that uses glucagon and insulin (bihormonal) to automate their glucose control based on continuous glucose monitor readings.
15989136|NCT02969863|Device|Insulin Only Bionic Pancreas|Participants will wear a Bionic Pancreas that uses just insulin (insulin-only) to automate their glucose control based on continuous glucose monitor readings.
15989137|NCT02969863|Other|Monitored for Hypoglycemia|During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity and hypoglycemia, and will be notified by study staff any time their continuous glucose monitor reads less than 50 mg/dl for 15 mintues.
15989138|NCT02969863|Other|Not Monitored for Hypoglycemia|During half of the study arms (one each bihormonal bionic pancreas, insulin-only bionic pancreas and usual care) the subjects will be remotely monitored for device connectivity only, not hypoglycemia.
15989142|NCT02969837|Drug|Elotuzumab|Elotuzumab will be given on Cycles 1-2 on days 1, 8, 15, 22, Cycles 3 and Beyond on days 1 and 15
15989205|NCT02969369|Drug|Placebo capsule|Placebo once daily
15989143|NCT02969837|Drug|Carfilzomib|Carfilzomib will be given on Day 1 and 8 of Cycle 1, Days 1, 8, and 15 of Cycles 2-8, and Days 1 and 15 of Cycles 9 and beyond
15989144|NCT02969837|Drug|Lenalidomide|Lenalidomide will be given on days 1-21 for all cycles.
15989145|NCT02969837|Drug|Dexamethasone|"Dexamethasone will be given as follows:
~Cycle 1 and 2: Days 1, 2, 8, 9, 15, 16, and 22 Cycles 3 and Beyond: Days 1, 8, 15, and 22"
15989146|NCT02969824|Behavioral|Supervised Aerobic Exercise|The AE protocol will consist of eight sessions that proceed in a stepwise fashion in terms of duration and intensity over 11 days. Exercise will be performed on the Velotron Pro stationary cycle ergometer (RacerMate Inc., WA, USA), which will be digitally connected to a heart rate monitor and programmed to monitor the wattage of the bike based on the participant's heart rate. Exercise duration (15min-20min) and intensity (60%-75% max HR) will increase over the intervention period. For the remotely supervised sessions, exercise intensities and heart rate will be monitored via FitBit.
15989147|NCT02969798|Drug|Dapagliflozin|10mg/day
15989148|NCT02969798|Drug|Saxagliptin|5mg/day
15989149|NCT02969798|Drug|Pioglitazone|the dose will increase from 15 mg/day to 30 mg/day at month two
15989150|NCT02969798|Drug|Metformin|starting at 1000 mg/day and increased to 2000 mg/day at month 2.
15989151|NCT02969785|Other|G1: exercises for lumbar stabilization|Specific exercises for lumbar stabilization. The Group 1 (G1) will perform therapy with specific exercises for lumbar stabilization whith the Swiss ball as a therapeutic resource, including warming; stretching of hamstrings, paraspinals, trapezes; phasic perineal exercise; tonic perineal exercise; pelvic lumbar synergism; trunk mobility; mobility of the shoulder girdle; balance; and slow pelvic balance.
15989152|NCT02969785|Other|G2: back strengthening exercises|Specific back exercises. The Group 2 (G2) will perform therapy including back strengthing exercise on a Roman chair machine to perform flexion and extension of trunk with load progressive training.
15989153|NCT02969772|Other|Assessment of upper limb variables|International Standards for Neurological and Functional Classification of Spinal Cord Injuries of American Spinal Injury Association (ASIA); Functional Independence Measure (FIM); The following kinematic variables of arm were studied: shoulder, elbow and wrist angles; percentage of time to peak velocity; movement time; peak velocity and movement smoothness (number of velocity peaks and index of curvature); Capabilities of Upper Extremity instrument (CUE); Spinal cord independence measure (SCIM II); electromyography (Clavicular portion of pectoralis major, long head of biceps brachii, anterior and posterior deltoid, triceps and wrist extensors).
15989154|NCT02969772|Other|Training protocol|The strengthening sessions consisted of 20 minutes of electrical stimulation on triceps, extensor carpi radialis longus, extensor digitorum communis, lumbricalis, flexor digitorum superficialis and opponens pollicis muscles. The functional training sessions was performed through movements the reach and palmar grasp with NMES of the several cylindrical and conical objects of different weights (30 minutes sessions).
15989155|NCT02969759|Other|Skin Biopsy|
15989156|NCT02969746|Drug|Activated Charcoal|"Patients will take oral activated charcoal after randomization in the intervention arm.
~A blood sample(TO) will be collected after patient enrollment and before charcoal administration and 4 blood samples will be collected on a 8h length period (T1 to T4)"
15989157|NCT02969733|Drug|Xylocaine|Xylocaine is administered at a dose of 1.5 mg / kg for induction and then relay by syringe pump at a dose of 1.33 mg / kg / hour will be administered throughout the duration of the intervention and for 24 hours after the end of thereof, to obtain deemed effective plasma concentrations of the order of 0.5 to 5 mcg / mL.
15989158|NCT02969733|Drug|Ketamine|Ketamine will be administered at a dose of 0.5 mg / kg and then relay by syringe pump at a dose of 0.05 mg / kg / hour for the duration of surgery and 24 hours after the end thereof.
15989159|NCT02969733|Drug|isotonic saline serum intravenous administration|
15989160|NCT02969720|Dietary Supplement|Phytosterols|Oral daily consumption of 2 grams of phytosterols (8 ml) per 180 days.
15989161|NCT02969720|Dietary Supplement|Titanium Dioxide|Oral daily consumption of Titanium Dioxide (8 ml) per 180 days.
15989162|NCT02969707|Device|MagPro TMS system (MagVenture, Denmark)|The investigators will perform two applications of 40s of continuous theta-burst stimulation (cTBS) form of rTMS at 80% resting motor threshold (previously determined), with a 15 minute intersession interval. The standardized treatment location for the left DLPFC will be determined by Localite Neuronavigation and targeted at the posterior middle frontal gyrus. The baseline structural scan obtained during the scan 1 will be utilized for this localization process. rTMS will be delivered using a MagPro TMS system (MagVenture, Denmark). sham rTMS will be delivered using a MagPro TMS system (MagVenture, Denmark).sham rTMS will be delivered using a MagPro TMS system (MagVenture, Denmark).
15989163|NCT02969707|Behavioral|Hypnosis|Hypnotizability will be measured using the Hypnotic Induction Profile before and after administration of real vs. sham rTMS. Hypnotizability will be measured using the Hypnotic Induction Profile before and after administration of real vs. sham rTMS. Hypnosis will be employed to influence Stroop performance (conflict detection) and for pain management. The hypnotic instructions for this will be pre-recorded and played during fMRI.
15989164|NCT02969694|Other|G-STAT questionnaire|"Patients will have a consultation with an addiction specialist physician. During the consultation, the physician ask the patient about these sexual practice and the use of psychostimulants. The patient will answer to the G-STAT questionnaire. This questionnaire allows the physician to perform an initial assessment of the patient's sexual addiction.
~The entire consultation takes place in the usual practice of consultations for this addiction."
15989165|NCT02969681|Drug|ascorbic acid|1.5g/kg/day, D1-3, every 2 weeks
15989166|NCT02969681|Drug|Chemotherapy|"mFOLFOX6
~Oxaliplatin 85 mg/m² d1 concurrent with
~Leucovorin 400 mg/m², followed by
~Bolus 5FU 400 mg/m² , followed by
~Infusional 5FU 2400 mg/m² over 46 hours, every 2 weeks
~with or without bevacizumab 5mg/kg, every 2 weeks"
15989167|NCT02969655|Drug|Daprodustat small|Available as 7.0 millimeter (mm) round, standard biconvex, white film coated tablets containing 1 mg, 2 mg, or 4 mg of daprodustat as active ingredient
15989168|NCT02969655|Drug|Daprodustat small placebo|Available as 7.0 mm round, standard biconvex, white film coated tablets containing no daprodustat
15989169|NCT02969655|Drug|Daprodustat large|Available as 9.0 mm round, standard biconvex, white film coated tablets containing 6 mg of daprodustat as active ingredient
15989170|NCT02969655|Drug|Daprodustat large placebo|Available as 9.0 mm round, standard biconvex, white film coated tablets containing no daprodustat
15989171|NCT02969655|Drug|Darbepoetin alfa|Available as 0.5 mL plastic prefilled syringes (PFS) for IV injection each containing 10, 15, 20, 30, 40 or 60 mcg of darbepoetin alfa in a clear and colorless solution.
15989172|NCT02969655|Drug|Darbepoetin alfa placebo|Available as 0.5 mL plastic PFS for IV injection containing no darbepoetin alfa in a clear and colorless solution.
15989173|NCT02969642|Device|Argus Migraine Treatment device|treatment of Migraines targeting Sphenopalatine ganglion
15989174|NCT02969629|Drug|Apomorphine|
15989175|NCT02969629|Drug|Normal Saline|
15989176|NCT02969616|Biological|Trinity Elite|cell based allograft
15989177|NCT02969603|Other|Magnetic Resonance Imaging|Magnetic Resonance Imaging as reference
15989178|NCT02969603|Other|Magnetic Resonance combined with Positron Emission Tomography|Comparison with MRI only, to assess muscular activity, creation of anatomic images of muscle activity and resolution of metabolic activity distribution within exercising skeletal muscle
15989179|NCT02969590|Drug|Leuprolide acetate|Following this spontaneous cycle, participants received a single intramuscular injection of leuprolide acetate (11.25mg, LupronVR; Abbvie, Chicago, IL), a dose documented to suppress ovarian function for at least 3 months. Ovarian suppression is confirmed with serum E2 less than or equal to 35 pg/ml 21-28 day post-injection.
15989180|NCT02969590|Drug|Estrogen and Progesterone Replacement|Replace hormones exogenously to create an artificial cycle
15989181|NCT02969590|Drug|Progestin|Synthetic progestin to assess effects on cervical mucus.
15989182|NCT02969577|Behavioral|Exercise Program|Participants will have a personal training session at the first visit. A member of the study team will discuss strength training and cardiovascular workouts for them to complete over the first 6 months of the study. A member of the study team will then talk with the participant every week for the first 3 months and monthly afterwards until month 6. Participants will be sent exercise videos and be given recommendations for the exercise program via phone calls and will be tailored to the individual. Videos and recommendations will be sent directly to the participant's smartphone.
15989183|NCT02969577|Behavioral|Diet and Nutrition Coaching|Diet and nutrition coaching session with an overview of resources on the smartphone. Over the first 6 months, participants will receive healthy recipes and nutritional information on the smartphone.
15989184|NCT02969577|Other|Usual Care with Attention|Participants will receive the usual care for men undergoing ADT. This includes monitoring blood work and answering questions about how they are feeling. Participants will be directed to the IMPACT website for education materials on prostate cancer.
15989185|NCT02969564|Other|scintigraphy 99mTc-MDP-SPECT/CT.|SPECT/CT will be performed for every patient in the frame of their clinical follow up
15989186|NCT02969564|Other|18F-NaF-PET/MR|a 18F-NaF-PET/MR will be performed, in the frame of this clinical study, to the patients to assess the difference of sensitivity of the 2 exams
15989187|NCT02969551|Device|Manometry and possibly DISE|A Manometry is performed on all patients. After it in some Patient DISE is followed
15989188|NCT02969538|Other|Total etching time|Apply 35% phosphoric acid on dentin and enamel by 15 seconds.
15989189|NCT02969538|Other|Half-reduced etching time|Apply 35% phosphoric acid on enamel by 15 seconds and dentin by 7 seconds.
15989190|NCT02969525|Other|Placebo|
15989191|NCT02969525|Drug|Bimekizumab|Bimekizumab in different dosage regimens.
15989194|NCT02969473|Drug|Docetaxel|"Radiotherapy: All patients underwent conventional radiotherapy, 1.8-2.0 Gy per fraction and 5 fractions per week. The prescribed dose was 60-64 Gy to PTV1 and 50 Gy to PTV2. Patients received either three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiation therapy (IMRT). 3D-CRT treatment plans were calculated by Pinnacle planning system and IMRT treatment plans were calculated by Monacle planning system. All patients were treated with a 6-MV or 8-MV linear accelerator.
~Chemotherapy: All patients received two cycles of chemotherapy concurrently with radiotherapy. Patients assigned to the DP group received two cycles of DP regimen (docetaxel 60 mg/m2 delivered on day 1 and cisplatin 80 mg/m2 delivered on day 1) at a 3-week interval. In cases of grade 4 hematologic toxicity or severe non-hematologic toxicities, dose adjustment was performed in the subsequent chemotherapy cycle."
15989195|NCT02969473|Drug|Fluorouracil|"Radiotherapy: All patients underwent conventional radiotherapy, 1.8-2.0 Gy per fraction and 5 fractions per week. The prescribed dose was 60-64 Gy to PTV1 and 50 Gy to PTV2. Patients received either three-dimensional conformal radiotherapy (3D-CRT) or intensity-modulated radiation therapy (IMRT). 3D-CRT treatment plans were calculated by Pinnacle planning system and IMRT treatment plans were calculated by Monacle planning system. All patients were treated with a 6-MV or 8-MV linear accelerator.
~Chemotherapy: All patients received two cycles of chemotherapy concurrently with radiotherapy. Patients assigned to the PF group received two cycles of PF regimen (cisplatin 80 mg/m2 delivered on day 1 and 5-FU 1000 mg/m2 continuous infusion over 24 hours daily on days 1-4) at a 3-week interval. In cases of grade 4 hematologic toxicity or severe non-hematologic toxicities, dose adjustment was performed in the subsequent chemotherapy cycle."
15989196|NCT02969460|Behavioral|Neurotrack Virtual Cognitive Health Program|
15989197|NCT02969447|Drug|Administration of 10 units of intra venous oxytocin after fetal expulsion|
15989198|NCT02969434|Other|Sleep assessment tools|Interventions are 3 tools to assess sleep: Verran Snyder Halpern sleep scale, the Pain and Sleep Questionnaire 3 Item Index (PSQ-3) and the Pittsburg Sleep Quality Index (PSQI).
15989199|NCT02969421|Other|Cough method for placement of tenaculum|The intervention in this arm is the placement of tenaculum via cough method
15989200|NCT02969421|Other|Slow Tenaculum Placement of tenaculum|The intervention in this arm is the placement of tenaculum via slow method
15989201|NCT02969408|Drug|Albuterol Sulfate|Albuterol sulfate will be administered as per the dose and schedule specified in the arm.
15989206|NCT02969356|Biological|Botulinum toxin type A|Dysport® administered in both upper and lower limbs (total dose of 1500 U per injection split between the 2 limbs).
15989207|NCT02969356|Other|GSC|The GSC is a motivational tool. The physiotherapist will teach each subject the stretching postures and exercises to perform on a daily basis throughout the study. These will be tailored to the individual subject's needs and will form the GSC therapy.
15989208|NCT02969343|Behavioral|Patient Safety health information technology|Patient safety technology toolkits on hospital care units
15989209|NCT02969330|Device|Stimulator|
15989210|NCT02969330|Dietary Supplement|Glucose|300ml tap water with 75g glucose
15989211|NCT02969317|Drug|Tiotropium|Fixed dose combination
15989212|NCT02969317|Drug|Olodaterol|Fixed dose combination
15989213|NCT02969304|Drug|dimethyl fumarate|"Off-Label Use: All participants <18 years of age and participants without an MS diagnosis who are prescribed dimethyl fumarate
~On-Label Use: All participants >18 years of age with an MS diagnosis who are prescribed dimethyl fumarate"
15989214|NCT02969291|Behavioral|Reduced Sedentary Time Intervention (RSTI)|Following 7 days of baseline activity monitoring a study investigator will download the information from the monitor, evaluate the periods of sedentary behavior and create a tailored RSTI for each participant. For example, the investigator may notice a long stretch of sitting in the evening following a meal and identify several exercises that can be done indoors during that time, or if the participant is amiable to walking breaks and a period after work is identified the investigator might suggest the appropriate walking activity at that time. This program has been successful in sedentary overweight office workers and investigators will use similar techniques.
15989215|NCT02969278|Procedure|18FDG-PET/TC|Nuclear medicine exam (18FDG-PET/TC) to assess the status of the regional groin and pelvic lymphnodes
15989216|NCT02969278|Procedure|Sentinel node biopsy|Intradermal injection of 0.2 ml 37-148 MBq of radiocolloid and a blue dye near the tumor to locate the position of the sentinel lymph node. Intraoperatively, sentinel node localization is guided by a gamma probe and by the eyes of the surgeon who detects the lymph nodes that are stained with the blue dye.
15989217|NCT02969265|Drug|Amlodipine|Amlodipine Capsules
15989218|NCT02969265|Drug|TCV-116CCB|TCV-116CCB Tablets
15989219|NCT02969265|Drug|Amlodipine Placebo|Amlodipine placebo-matching capsules
15989220|NCT02969265|Drug|TCV-116CCB Placebo|TCV-116CCB 8/5 mg placebo-matching tablets
15989221|NCT02969252|Drug|Rifamycin SV-MMX® 600|
15989222|NCT02969239|Drug|Norepinephrine|bolus administered norepinephrine 5mcg intravenously, if SBP <90mmHg or 20% decrease from baseline
15989223|NCT02969239|Drug|Phenylephrine|bolus administered phenylephrine 100mcg intravenously, if SBP <90mmHg or 20% decrease from baseline
15989224|NCT02969226|Procedure|Once daily screening|RTs will screen invasively ventilated patients between approximately 06:00 - 08:00 hours daily. To pass the 'readiness to wean screen' and undergo an SBT, specific criteria must be met.
15989225|NCT02969226|Procedure|Twice daily screening|In the 'at least twice daily' screening arm patients will be screened at a minimum between approximately 6:00-8:00 hours and 13:00-15:00 hours daily. To pass the 'readiness to wean screen' and undergo an SBT, specific criteria must be met.
15989226|NCT02969226|Procedure|PS SBTs|Patients are assigned a SBT technique. All SBTs for these patients must be conducted on PS >0 and =< 8 cm H2O with PEEP>0 and =< 5 cm H2O
15989227|NCT02969226|Procedure|T-piece SBTs|Patients are assigned a SBT technique. All SBTs for these patients must be conducted with T-piece (off the ventilator)
15989228|NCT02969200|Drug|Enzyme replacement therapy|All patients included in the study have received enzyme replacement therapy with either agalsidase alfa and/or agalsidase beta
15989229|NCT02969187|Drug|Exparel|6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Exparel will be injected at port sites.
15989230|NCT02969187|Drug|Bupivacain|6 trocars are placed to perform LRYGB or LSG: two 12 mm trocars and four 5 mm trocars. Bupivacain will be injected at port sites.
15989231|NCT02969187|Drug|Saline|
15989232|NCT02969174|Other|zimin Lu,Guo Sa|chengzhong Liu
15989233|NCT02969148|Procedure|Laparoscopic bursectomy and D2 lymphadenectomy|The anterior lobe of transverse mesocolon and capsula pancreatis will be dissected with the D2 lymphadenectomy according to the guidelines of National Comprehensive Cancer Network(NCCN) by laparoscopy，this is Laparoscopic bursectomy and D2 lymphadenectomy.
15989234|NCT02969148|Procedure|Laparoscopic D2 lymphadenectomy|D2 lymphadenectomy is carried out according to the guidelines of National Comprehensive Cancer Network(NCCN).
15989235|NCT02969135|Behavioral|Progressive early passive and active movement|Post-surgical physical therapy including active exercise
15989236|NCT02969135|Behavioral|Limited early passive movement|Post-surgical physical therapy including passive mobilisation
15989237|NCT02969122|Procedure|standard gastrectomy with D2 lymphadenectomy|standard distal or total gastrectomy and accorded D2 lymphadenectomy
15989238|NCT02969122|Procedure|hyperthermic intraperitoneal chemotherapy|Intraperitoneal docetaxel of 100mg/m2 at 42℃ for 30 minutes
15989239|NCT02969122|Procedure|Extensive intraperitoneal lavage|Lavage of peritoneal cavity with 1000ml saline for 10 times
15989240|NCT02969122|Other|Preoperative chemotherapy|Oxaliplatin 130mg/m2 D1 S-1 40-60mg Bid D1-14 Repeated every 3 weeks.
15989241|NCT02969122|Other|Postoperative chemotherapy|SOX regimen postoperative chemotherapy (Oxaliplatin 130mg/m2 D1, S-1 40-60mg Bid D1-14, Repeated every 3 weeks) for surgery-first arm. Regimen for chemotherapy-first arm is determined according to the postoperative pathologic evaluation of response.
15989242|NCT02969096|Procedure|Targeted Cryoablation Therapy|A cryoprobe is inserted percutaneously under CT guidance into the targeted lesion. Patients undergo ablation using a freeze-thaw-freeze cycle lasting approximately 6-10-6 or 8-10-8 minutes, respectively.
15989243|NCT02969083|Procedure|RNU|Radical surgical removal by open or laparoscopic access
15989244|NCT02969083|Drug|Gemcitabine/Cisplatin|Gemcitabine (1000 mg/m²) day 1 and 8 and Cisplatin (70 mg/m²) day 1
15989245|NCT02969083|Drug|M-VAC Protocol|Methotrexate (30 mg /m²) and Vinblastine 3 (mg /m²) day 1; Adriamycin 30 mg /m² and Cisplatin 70 mg /m² in day2
15989246|NCT02969070|Dietary Supplement|LopiGLIK™ therapy|4 weeks of LopiGLIK™ therapy 1 capsule/day
15989247|NCT02969070|Dietary Supplement|Armolipid Plus® therapy|4 weeks of Armolipid Plus® therapy 1 capsule/day
15989248|NCT02969057|Other|Breakfast with rice bran oil gel|25 grams of rice bran oil gel
15989250|NCT02969057|Other|Breakfast with palm oil gel|25 grams of palm oil gel
15989251|NCT02969057|Other|Breakfast with palm oil|25 grams of palm oil
15989252|NCT02969044|Drug|Placebo|
15989253|NCT02969044|Drug|PF-06651600|200mg pill every day (QD) for 8 weeks
15989254|NCT02969031|Behavioral|Enhanced SCOPE training|Intervention is integrated into the American Board of Internal Medicine (ABIM) Maintenance Of Certification (MOC) process.
15989255|NCT02969031|Behavioral|Standard Communication training|Standard Communication training
15989256|NCT02969018|Drug|PF-06700841|
15989257|NCT02969018|Other|Placebo|
15989258|NCT02969005|Radiation|surgical treatment|Use of a radiopaque localizer grid and methylene blue staining as an aid to resect the lesions
15989259|NCT02968992|Drug|rhLactoferrin|Eligible participants will be provided with Recombinant Human lactoferrin (rhLF) in 250 mg capsules along with detailed instructions for taking the study drug and they will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.
15989260|NCT02968992|Other|Placebo|Eligible participant will be provided with placebo in capsules of 250 mg along with detailed instructions for taking the placebo. Participants will be asked to take six 250 mg capsules twice a day and to keep a daily dosing dairy.
15989261|NCT02968966|Other|Therapy regime|Patient will receive Phenytoin, if no success is obtained, Vimpat is given. In case of success after one of the treatments, the endpoint is reached. Success is defined as reduction of seizures to 50% compared to baseline.
15989262|NCT02968953|Drug|Triheptanoin|A single patient with Glucose Transporter 1 (GLUT1) Deficiency Syndrome will receive tripheptanoin (UX007).
15989263|NCT02968940|Biological|Avelumab|Avelumab 10 mg/kg intravenously (IV) every 2 weeks
15989264|NCT02968940|Radiation|Hypofractionated radiation therapy (HFRT)|Hypofractionated radiation therapy to a total dose of 30 Gy, delivered in 6 Gy per fraction for 5 consecutive daily fractions
15989265|NCT02968927|Drug|Everolimus 0.5 MG|
15989266|NCT02968927|Drug|Auranofin 6 MG|
15989267|NCT02968927|Drug|Vitamin D3|
15989268|NCT02968927|Drug|CC-11050|
15989269|NCT02968927|Drug|2HRbZE/4HRb|
15989270|NCT02968914|Biological|Benralizumab|A humanized, afucosylated, monoclonal antibody (mAb) that binds specifically to the human IL-5 receptor alpha subunit (IL-5Rα) on the target cell.
15989271|NCT02968914|Biological|Benralizumab|A humanized, afucosylated, monoclonal antibody (mAb) that binds specifically to the human IL-5 receptor alpha subunit (IL-5Rα) on the target cell.
15989272|NCT02968901|Drug|macitentan|used in open label
15989273|NCT02968901|Drug|tadalafil|used in open label
15989274|NCT02968888|Other|Strength training|
15989275|NCT02968888|Dietary Supplement|Milk 1%|
15989276|NCT02968888|Dietary Supplement|Whey protein concentrate 80|
15989277|NCT02968888|Dietary Supplement|Native whey|
15989278|NCT02968875|Device|Endurance Training|40 people will submitted to endurance training: 20 will perform a continuous training and 20 will perform an interval training. The variables that will be analyzed are maximum aerobic power, endurance, heart rate, prehension strength, Mini-Mental State Examination (MMSE), REY's test, biological examination and level of BDNF plasma, before and after the intervention and one month after the end of the intervention and one month after the end of the intervention.
15989279|NCT02968875|Other|therapeutic education meetings|Group of 20 people will be the control group and will not perform ET. However, they will have 9 therapeutic education meetings.
15989280|NCT02968862|Other|observational|The study will involve adult patients undergoing elective thoracolumbar-sacral spine surgery involving 1-5 spine levels, at the Brigham and Women's hospital that have an anticipated post surgical hospital stay of one to three days. These patients will be randomly assigned by the BWH Investigational Drug Service to one of three different groups, each consisting of 33 patients. This is an observational studies with subjects in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive a therapeutic intervention, but the investigator does not assign specific interventions to the subjects of the study.
15989281|NCT02968849|Biological|ALVAC-HIV (vCP2438)|Expresses the gene products ZM96 gp120 (clade C strain) linked to the sequences encoding the HIV-1 transmembrane anchor (TM) sequence of gp41 (28 amino acids clade B LAI strain) and gag and pro (clade B LAI strain). It is formulated as a lyophilized vaccine for injection at a dose > 10^6 cell culture infectious dose 50% (CCIDv50) and < 1 × 10^8 CCIDv50 (nominal dose of 10^7 CCIDv50) and is reconstituted with 1 mL of sterile sodium chloride solution (NaCl 0.4%) delivered IM
15989282|NCT02968849|Biological|Bivalent Subtype C gp120/MF59|Subtype C TV1.C gp120 Env and 1086.C gp120 Env proteins, each at a dose of 100 mcg, mixed with MF59 adjuvant (an oil-in-water emulsion) and delivered IM
15989283|NCT02968849|Biological|Placebo|Sodium Chloride for injection, 0.9% delivered IM
15989284|NCT02968836|Dietary Supplement|Blend of amino acids|The product will be poured in bottles containing the enteral nutrition that the patient receives as standard of care.
15989285|NCT02968836|Dietary Supplement|Maltodextrin only|The product will be poured in bottles containing the enteral nutrition that the patient receives as standard of care.
15989286|NCT02968823|Other|Licorice|ExtractumLiquiritiaeFluidum, 1 g diluted in 30cc water, gargle the solution for 60 seconds without swallowing it starting preoperatively, 3 times a day until post-operative day 2
15989287|NCT02968823|Other|Sugar water|Sugar gargle: Sirupus Simplex (sugar 5 g) diluted in 30cc water, gargle the solution for 60 seconds without swallowing it starting preoperatively, 3 times a day until post-operative day 2
15989288|NCT02968810|Other|Placebo Administration|Given PO
15989289|NCT02968810|Other|Questionnaire Administration|Ancillary studies
15989290|NCT02968810|Drug|Simvastatin|Given PO
15989291|NCT02968797|Device|SafeSed|Monitor respiratory parameters
15989292|NCT02968784|Device|ExAblate MRgFUS|ExAblate treatment of prostate cancer less than or equal to Grade 7
15989293|NCT02968771|Other|Non intervention|
15989294|NCT02968758|Device|Comparison between GenePOC PCR and Reference Method|Stool specimen will be tested with the GenePOC CDiff test on the GenePOC Instrument. The results will be compared to Reference Method defined as direct and enriched culture method for observation of a toxigenic Clostridium difficile strain.
15989295|NCT02968745|Other|Observational study|Canadian Occupational Performance Measure (COPM) was applied to identify the main occupational performance problems
15989297|NCT02968719|Drug|Donepezil TDS Version A|Donepezil Hydrochloride Transdermal Delivery System (5mg and 10 mg Version B)
15989298|NCT02968719|Drug|Donepezil TDS Version B|Donepezil Hydrochloride Transdermal Delivery System (5 mg and 10 mg Version B)
15989299|NCT02968719|Drug|Aricept|Aricept (5 mg and 10 mg) Donepezil Hydrochloride
15989300|NCT02968719|Drug|Donepezil TDS Version D|Donepezil Hydrochloride Transdermal Delivery System (5 mg Version D)
15989301|NCT02968719|Drug|Donepezil TDS Version E|Donepezil Hydrochloride Transdermal Delivery System (5 mg Version E)
15989302|NCT02968706|Device|High Flow Nasal Cannula|Heated humidified high flow oxygen of 50 L/min at FiO2 of 40%
15989303|NCT02968706|Device|Conventional Nasal Cannula|Supplemental oxygen of 2-5 L/min
15989304|NCT02968706|Other|Patient satisfaction questionnaire|Questionnaire
15989305|NCT02968693|Device|antibiotic-loaded calcium sulfate|To obtain a paste suitable for pellets, the following steps should be used: 1. Empty 10 cc Stimulan® calcium sulfate powder (Stimulan; Biocomposites Ltd; United Kingdom) into a sterile mixing bowl. 2. The calcium sulfate powder was mixed with 2,000 mg of vancomycin powder. 3. Add approximately 5 ml mixing solution into the above mixture. Mix thoroughly until a smooth paste is formed (approximately 30 seconds). 4. The resultant paste is uniformly smooth into the mould provided to form pellets with diameters of 4.8 mm and height of 3.3 mm. 5. Allow paste to cure undisturbed for at least 15 minutes after mixing. Flex mould to release pellets.
15989306|NCT02968693|Device|antibiotic-loaded polymethyl methacrylate|One sachet of 40g PALACOSR®+G power containing 33.6g PMMA and with the addition of 0.5g gentamicin sulphate (Heraeus Medical Gesellschaft mit beschränkter Haftung,Germany) was mixed with 4,000 mg of vancomycin powder in a sterile bowl. The liquid provided was poured into the resultant mixture above. Then, the mixture was stirred carefully for 30 sec. If the dough-like mass no longer sticked to the rubber gloves, it can be progressed. If the required consistency was obtained, the cement can be applied to the bony defect until it hardened completely.
15989307|NCT02968693|Drug|Vancomycin|Vancomycin powder was added into the combination therapy group and PMMA groups
15989308|NCT02968680|Procedure|Sentinel Lymph Node Biopsy|Undergo SLNB
15989309|NCT02968680|Device|Ultrasonography|Undergo sonazoid-enhanced ultrasonography
15989310|NCT02968680|Drug|Sonazoid|Patients receive sonazoid intradermally (ID) and undergo ultrasound imaging.
15989311|NCT02968667|Behavioral|Empowerment|6 weeks of empowerment program and supported face to face discussion
15989312|NCT02968654|Procedure|Restrictive Transfusion Strategy|"Patients will be randomized when hemoglobin levels will be below 9 g/dl. Patients randomized to the Restrictive Transfusion Strategy will receive blood transfusion whenever their Hb concentration is < 7 g/dl. All patients should preferably receive one unit of blood transfusion at a time. The duration of the intervention is 28 days after randomization or until hospital discharge. Daily assessment of hemoglobin levels are mandatory only during the ICU stay. No other procedures and or interventions are scheduled. General management of patients will be conducted according to international guidelines; however, local protocols and procedures are allowed."
15989313|NCT02968654|Procedure|Liberal Transfusion Strategy|"Patients will be randomized when hemoglobin levels will be below 9 g/dl. Patients randomized to the Liberal Transfusion Strategy will receive blood transfusion whenever their Hb concentration is < 7 g/dl. All patients should preferably receive one unit of blood transfusion at a time. The duration of the intervention is 28 days after randomization or until hospital discharge. Daily assessment of hemoglobin levels are mandatory only during the ICU stay. No other procedures and or interventions are scheduled. General management of patients will be conducted according to international guidelines; however, local protocols and procedures are allowed."
15989314|NCT02968641|Drug|Lonafarnib|antiviral farnesyltransferase inhibitor
15989315|NCT02968641|Drug|Ritonavir|CYP 3A4 inhibitor, lonafarnib booster
15989316|NCT02968628|Other|Video Electroencephalogram (EEG)|Single neonatal video EEG at 24 hrs to 5 days of life during birth hospitalization. Neonatal scalp leads, respiratory and nasal leads. Approximately 60 minute recording.
15989317|NCT02968628|Other|Point-of Care Blood Sugar Testing|One-time heel-stick point-of-care blood sugar testing at time of EEG.
15989318|NCT02968628|Other|Medical Record Data Extraction|Medical record data extraction from both maternal obstetric and neonatal medical record for variables known to impact EEG and neurodevelopmental outcomes.
15989319|NCT02968628|Other|Maternal Questionnaire|One-time maternal questionnaire related to smoking practices, ETOH consumption, level of education, and body mass index.
15989320|NCT02968615|Behavioral|Dietary Intervention|Participants were instructed to increase both their dietary fiber intake to 35 g/day and protein intake to 0.8 g per kilogram/day of their ideal body weight. Patients in both conditions will receive intensive dietary instruction for 6 weeks, followed by a 6 weeks maintenance phase. Participants received dietary instructions via individual and group sessions led by registered dietitians.
15989323|NCT02968589|Behavioral|Training|
15989324|NCT02968576|Drug|TENOFOVIR DISOPROXIL FUMARATE 300 Mg / EMTRICITABINE 200 Mg ORAL TABLET [TRUVADA]|
15989325|NCT02968576|Device|Proteus Sensor System|
15989326|NCT02968563|Drug|Tirabrutinib|80 mg (1 x 80 mg or 4 x 20 mg or 2 x 40 mg) tablets administered orally once daily
15989327|NCT02968563|Drug|Idelalisib|100 mg (1 x 100 mg) tablets administered orally once daily
15989328|NCT02968563|Drug|Obinutuzumab|100 mg on Day 1, 900 mg on Day 1 or 2, and 1000 mg subsequently for up to 8 doses administered intravenously over 21 weeks
15989329|NCT02968537|Behavioral|Alc-IT (50/50) (morning)|This alcohol-specific inhibition-training (Alc-IT) training group will operate with a Go/NoGo ratio of 50/50 (Houben et al. 2011; 2012): This original version of the Alc-inhibition-training will include 80 alcoholic NoGo trials as well as 80 non-alcoholic Go trials. In order to arrive at the same training length while keeping the number of Alc-NoGo-pairings constant and the Go/NoGo-ratio at 50/50, it will additionally include 80 neutral Go-trials as well as 80 neutral NoGo-trials. It will thus consist of 320 trials and take about 10.5 minutes to be completed. In the morning group, this training will be administered within the first 2 hours after awakening.
15989360|NCT02968303|Drug|Vemurafenib and Cobimetinib|Combination of Vemurafenib with Cobimetinib in BRAF V600E/K mutated melanoma patients to normalize LDH and optimize immunotherapy with Nivolumab and Ipilimumab
15989330|NCT02968537|Behavioral|Alc-IT (75/25) (morning)|This version of the alcohol-specific inhibition-training (Alc-IT) will operate with a Go/NoGo-ratio of 75/25. It will equally include 80 Alcoholic NoGo-trials and 80 non-alcoholic Go-trials, but now 160 neutral Go-trials will complete the set. This training will also consist of 320 trials and take about 10.5 minutes. In the morning group, this training will be administered within the first 2 hours after awakening.
15989331|NCT02968537|Behavioral|Control-training (morning)|This group will receive an unspecific inhibition training. this training is of the same length and difficulty as the two Alc-inhibition-trainings. In the morning group, this training will be administered within the first 2 hours after awakening.
15989332|NCT02968537|Behavioral|Alc-IT (50/50) (afternoon)|"As in the arm Alc-IT (50/50) (morning), this alcohol-specific inhibition-training (Alc-IT) group will operate with a Go/NoGo ratio of 50/50 (Houben et al. 2011; 2012): This original version of the Alc-inhibition-training will include 80 alcoholic NoGo trials as well as 80 non-alcoholic Go trials. In order to arrive at the same training length while keeping the number of Alc-NoGo-pairings constant and the Go/NoGo-ratio at 50/50, it will additionally include 80 neutral Go-trials as well as 80 neutral NoGo-trials. It will thus consist of 320 trials and take about 10.5 minutes to be completed. In contrast to the In the morning group, this afternoon group will receive the training in the afternoon."
15989333|NCT02968537|Behavioral|Alc-IT (75/25) (afternoon)|"As in the arm Alc-IT (75/25) (morning), this version of the alcohol-specific inhibition-training (Alc-IT) will operate with a Go/NoGo-ratio of 75/25. It will equally include 80 Alcoholic NoGo-trials and 80 non-alcoholic Go-trials, but now 160 neutral Go-trials will complete the set. This training will also consist of 320 trials and take about 10.5 minutes. In contrast to the In the morning group, this afternoon group will receive the training in the afternoon."
15989334|NCT02968537|Behavioral|Control-training (afternoon)|"As in the arm Control-training (morning), this group will receive an unspecific inhibition training. This training is of the same length and difficulty as the two Alc-inhibition-trainings. In contrast to the In the morning group, this afternoon group will receive the training in the afternoon."
15989335|NCT02968511|Biological|fecal microbiota transplant|Fecal microbiota transplant for the treatment of severe, complicated C. difficile infection
15989336|NCT02968498|Dietary Supplement|Lactulose crystals 10 g|White or almost white crystalline powder used as food ingredient. The products will be provided in sachets to be dissolved in 250 mL water.
15989337|NCT02968498|Dietary Supplement|Lactulose crystals 20 g|White or almost white crystalline powder used as food ingredient. The products will be provided in sachets to be dissolved in 250 mL water.
15989338|NCT02968498|Dietary Supplement|Lactulose liquid 10 g|Clear, viscous liquid, colourless or pale brownish-yellow liquid syrup (solution). The products will be provided in sachets to be dissolved in 250 mL water.
15989339|NCT02968498|Dietary Supplement|Lactulose liquid 20 g|Clear, viscous liquid, colourless or pale brownish-yellow liquid syrup (solution). The products will be provided in sachets to be dissolved in 250 mL water.
15989340|NCT02968498|Dietary Supplement|Oral glucose 20 g|White crystalline powder used as food ingredient. To standardise for 20 g glucose, 22 g glucose monohydrate will be used. The products will be provided in sachets to be dissolved in 250 mL water.
15989341|NCT02968498|Dietary Supplement|Still water|Still water will be used. Water from the same source will be also used to dissolve investigational and control products.
15989342|NCT02968485|Drug|SHR7390|SHR7390 is provided as white, film-coated,immediate release tablets containing SHR7390 at dosage strengths of 0.125 mg and 0.5 mg. Multiple tablets of SHR7390 will be administered daily to achieve targeted doses of SHR7390: 0.25 mg-4 mg. Tablets will be orally administered with 240 ml water, once daily, 2 hours after a meal.
15989343|NCT02968472|Genetic|prophylactic 4SCAR19 cells|Autologous 4th generation withdrawal lentiviral-transduced 4S CAR-T19
15989344|NCT02968459|Other|Umbilical cord MSCs|Participants will receive direct local intramuscular injection of 1*10^7 MSCs (in 1ml of 0.9% saline) in the uterine incision.
15989345|NCT02968459|Other|0.9% Saline|Participants will receive direct local intramuscular injection 1ml of 0.9% saline in the uterine incision.
15989346|NCT02968446|Dietary Supplement|4 placebo|subjects will take orally 4 pills without any active ingredients which are of the same size, shape and color as the study pills
15989347|NCT02968446|Dietary Supplement|4 Vitamin D|subjects will take orally four pills for a single dose of 200,000 IU of Vitamin D (cholecalciferol)
15989348|NCT02968446|Drug|Valchlor|Twice during the study, subjects will be given 0.016% Valchlor at 3 locations (for a total of 6 locations) in the inner arm using Finn ChambersTM
15989349|NCT02968433|Drug|Infusions of young plasma|Participants will receive four twice- weekly infusions of 1 unit young plasma (male, ages between 18-25)
15989350|NCT02968420|Biological|Human Papillomavirus 9-valent Vaccine, Recombinant|All groups will receive a single dose of the Gardasil9 vaccine at Visit 1/Day 0 of the study.
15989351|NCT02968407|Other|Peer- and self-rating|Participants will be given a print and a e-mail of the modified OSATS global rating scale and will be introduced to how the rating scale is used to rate technical performance. The participant will receive a USB stick each allowing the participant to see a video of his/her own performance and two videos from previous post-test performances from participants enrolled in the course. One video is a video of a participant who performed poorly,the other is from a participant who performed well. The participants will be asked to watch and rate the videos of their peers' performance first and afterwards watch and rate the participants own video performance. The investigators choose to let the participants rate their peers' performances before their own, so the participants will have the best opportunities to self-rate. Participants will be asked to email the results of their ratings to the principal investigator within 3 days. And expert in surgery will also rate the videos using OSATS.
15989352|NCT02968394|Drug|omalizumab|
15989353|NCT02968381|Behavioral|Imagery Intervention|Telephone coaching sessions, use of guided imagery and website.
15989354|NCT02968381|Behavioral|Control Condition|Telephone coaching using standard cognitive behavioral methods
15989355|NCT02968368|Drug|Ferric maltol|
15989356|NCT02968368|Other|Placebo|
15989357|NCT02968355|Other|Observational study|Observational study
15989358|NCT02968342|Device|Vaginal progesterone 8%|vaginal self application
15989359|NCT02968316|Other|BIA measurement|observation only
15989361|NCT02968290|Procedure|Cataract Surgery|Implant of intraocular lens hydrophobic or Implant of intraocular lens hydrophilic (Device)
15989362|NCT02968290|Device|Alcon AcrySof SA60AT|Implant of intraocular lens hydrophobic
15989363|NCT02968290|Device|Bausch Lomb AkreosA|Implant of intraocular lens hydrophilic
15989364|NCT02968277|Device|LifeWalker Upright|LifeWalker (LW) upright walker
15989365|NCT02968277|Device|Predicate Device|Individual's personal walker
15989366|NCT02968277|Device|Standard Rollator|A control rollator device
15989367|NCT02968251|Behavioral|Hand Washing Program (HWP)|HWP consists of integrating hand washing practice in the school health policy, setting up proper hand washing facilities in the intervention schools, training to school teachers, delivering of health talk to schoolchildren and their parents, developing reminders and posters of a simplified 5-step hand washing technique, peer briefing session, take home package (5-steps hand washing, commitment letter, poster, leaflet). The program will be delivered once every week.
15989368|NCT02968238|Behavioral|Cognitive-behavioral therapy|10 weekly sessions of cognitive-behavioral therapy
15989369|NCT02968238|Behavioral|Yoga|10 weeks of biweekly yoga sessions (N = 20)
15989370|NCT02968225|Behavioral|Computer Game|The game involves viewing subtle nonverbal behaviors of game characters for the purpose of executing their own goal-directed behavior in the game related to solving various crimes. The learning involves interpreting nonverbal cues on the animated characters, such as pointing, head turns, eye gaze cues.
15989371|NCT02968212|Drug|Clofazimine|All participants in the experimental/treatment arm on this protocol will take a loading dose of 200 mg daily in soft capsule form of clofazimine for 16 weeks, dropping to 100 mg daily for the next 8 weeks.
15989372|NCT02968212|Other|sugar pill|All participants in the placebo arm on this protocol will take placebo in soft capsule form daily dropping to a smaller dose after 16 weeks to mirror the treatment arm dosing.
15989373|NCT02968199|Behavioral|A brief intervention|The content of the intervention includes: (1) asking about tobacco use; (2) advising cessation; (3) assessing willingness to quit; (4) assisting in the attempt to quit; and (5) arranging follow-up.
15989374|NCT02968186|Behavioral|Implementation program|Health professionals in the intervention arm will receive up to four training sessions in the first three months of the implementation period. Practice support will be continuously available throughout the project. Posters specifically designed for this project will be added to the primary health care units aiming to facilitate eliciting alcohol issues during the consultations, and to help professionals remembering to conduct alcohol screening and brief intervention. Leaflets to be handed-in to patients were also specifically produced for this project, aiming to aid professionals in advising at-risk drinkers to cut down. The research team will schedule with each primary health care unit regular visits for feedback on the progress of the program.
15989375|NCT02968173|Drug|Palivizumab|Palivizumab is a humanized immunoglobulin G1 (IgG1) monoclonal antibody directed to an epitope in the A antigenic site of the F (fusion) protein of RSV.
15989376|NCT02968160|Drug|Telmisartan 40mg + Rosuvastatin 20mg|
15989377|NCT02968160|Drug|Telmisartan 80mg + Rosuvastatin 20mg|
15989378|NCT02968160|Drug|Telmisartan 40mg, 80 mg|
15989379|NCT02968160|Drug|Rosuvastatin 20mg|
15989380|NCT02968147|Device|High frequency jet ventilation|General anaesthesia and ventilation with the Acutronic Monsoon III Jet ventilator system
15989381|NCT02968147|Device|Conventional ventilation|General anaesthesia and ventilation with a conventional Phillips intermittent positive pressure ventilator system
15989382|NCT02968134|Drug|Posaconazole|A single dose of 300mg intravenous posaconazole will be administered and blood samples will be taken prior to start of infusion, at 15,45,75minutes, 3,5,8,12,18,24,30,36 and 48 hours.
15989383|NCT02968121|Drug|Brexpiprazole, OPDC-34712|
15989385|NCT02968095|Behavioral|Text Message Craving Program|Text messages targeting cravings delivered 2-3 times per day.
15989386|NCT02968095|Behavioral|Self-Help Manual Plus Control Texts|Self-help manual plus motivational text messages delivered 2-3 times per day.
15989387|NCT02968082|Drug|Scopolamine|Patch will be applied under the ear of the opposite side of operation, at 9 p.m. of the day before the operation day. Nausea will be assessed by Visual Analogue Scale (VAS) immediate after arrival at a recovery room and the ward. After that, nausea will be continuously assessed every 4 hour (4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery) and a number of vomiting will also be counted. Basic clinical characteristics and the number of antiemetic administration will be identified through medical records.
15989388|NCT02968082|Drug|Placebo|Patch will be applied under the ear of the opposite side of operation, at 9 p.m. of the day before the operation day. Nausea will be assessed by Visual Analogue Scale (VAS) immediate after arrival at a recovery room and the ward. After that, nausea will be continuously assessed every 4 hour (4hr, 8hr, 12hr, 16hr, 20hr, and 24hr after surgery) and a number of vomiting will also be counted. Basic clinical characteristics and the number of antiemetic administration will be identified through medical records.
15989389|NCT02968069|Device|NBI|Endoscopic factors under white light view and simplified narrow band imaging classification assisting in diagnosing cancerous lesions will be recorded.
15989390|NCT02968056|Procedure|Radiofrequency ablation|Radiofrequency energy is used for ablation in both arms of this study (Hybrid group and MIS group)
15989391|NCT02968043|Other|physiotherapeutic scoliosis specific exercises|Physiotherapeutic scoliosis specific exercises (PSSE) is recommended as a first step in the treatment of AIS to halt curve progression by SOSORT guidelines. The PSSE program will be personalized according to the subject's curves characteristics. The program includes patient and family education, 3D self-correction, stabilizing exercises, balance training, breathing exercises, and training in activities of daily living. A physiatrist will give a detailed explanation of the aims, importance, methods, and procedure of an intervention to patients and their parents. Each subject will receive guidance from multiple physiotherapists to ensure that the treatment effects are the result of the protocol and not any particular physiotherapists.
15989392|NCT02968043|Other|generalised physiotherapy exercises|Generalised physiotherapy exercises includes stretching and strengthening activities. Little evidence is in favor of generalised physiotherapy exercises. Each subject will receive guidance from multiple physiotherapists.
15989393|NCT02968030|Other|Muscle strength|"Strength training The strength training for lower limbs muscles occurred twice a week, 40 minutes per session for eight consecutive weeks.
~n the first two weeks of training, each elderly performed the exercises with 50% of its load defined in 8RM test, increasing to 60 and 70% of the load in the third and fourth subsequent weeks, respectively. After this period, a new evaluation by 8RM strength test was conducted, adopting the fifth and sixth weeks of training 50% of value of the new load defined in 8RM test and to finalize the program in seventh and eighth weeks applied, respectively, 60% and 70% of the new charge. The exercises were performed for the quadriceps, hamstrings, muscles adductor and abductor hip."
15989394|NCT02968004|Drug|MOD-4023|Once weekly subcutaneous injection using pre-filled pen device.
15989395|NCT02968004|Drug|Somatropin|Once daily subcutaneous injection of Genotropin using pre-filled pen device.
15989396|NCT02967991|Device|EUS-guided liver biopsy|Endoscopic ultrasound guided liver biopsy
15989397|NCT02967965|Other|Imagery|MRI at year 3
15989398|NCT02967952|Device|supraglottic airway (SGA) V.S. endotracheal intubation (ETI)|already being described above
15989399|NCT02967939|Drug|DA-2802|DA-2802 319mg tablet qd + placebo tablet matching to Viread® 300mg.
15989400|NCT02967939|Drug|Viread®|Viread® 300mg tablet qd + placebo tablet matching to DA-2802 319mg.
15989401|NCT02967926|Procedure|Endoscopic Retrograde Cholangioscopy by SpyGlass (ERCS)|Digital SpyGlass Cholangioscopy to facilitate common bile duct stone removal
15989402|NCT02967913|Procedure|Bladder flap|bladder is separated from the lower uterine segment prior to making the uterine incision at time of cesarean delivery
15989403|NCT02967887|Drug|cisplatin and 5-fluorouracil|Hepatic arterial infusion of Cisplatin (60mg/m2 for 2h on day 2) and 5-fluorouracil (500mg/m2 for 5h on days 1-3) through implanted port system (chemoport)
15989404|NCT02967874|Procedure|Intra-articular auto-SVFs injection|Liposuction under local anesthesia followed by single intra-articular injection of auto-SVFs under the ultrasound navigation
15989405|NCT02967874|Drug|Hyaluronic Acid|Single intra-articular injection of Synocrom Forte 2% under the ultrasound navigation
15989406|NCT02967861|Behavioral|Pranayama|Pranayama is the breathing exercise through the nostrils. It enhances the systemic immunity which in turn enhances the overall defense mechanism of an individual.
15989407|NCT02967861|Procedure|Scaling and root planing|It is a mechanical debridement of dental plaque.
15989408|NCT02967848|Other|99mTc-mebrofenin hepatobiliary scintigraphy (HBS)|99mTc-mebrofenin HBS is a SPECT imaging procedure that allows evaluation of global and local liver function. Mebrofenin, bound to albumin, is taken up by hepatocytes in a similar manner to organic anions such as bilirubin. After hepatic uptake, the mebrofenin is excreted into the bile canaliculi. Dynamic imaging tools allow measurement of clearance rates for global function, and 3D SPECT imaging with corresponding CT allows visualisation of the local liver function with respect to anatomy. HBS allows direct visualisation of hepatocyte function.
15989409|NCT02967848|Other|Indocyanine Green|ICG is a fluorescent dye injected into the patient. The dye is exclusively excreted by the liver. The ICG clearance rate is measured in the finger of the subject.
15989410|NCT02967848|Other|Liver Elasticity|This is an Ultrasound measurement of the elasticity of the liver.
15989411|NCT02967835|Behavioral|Tele-psychiatry consult|tele-psychiatry consult for evaluation and treatment recommendations
15989412|NCT02967822|Genetic|Biological samples for patients|Blood samples. Sampling of uterine tissue during surgical intervention (collection of samples for the study only if samples remain after the routine care analyses)
15989413|NCT02967822|Genetic|Biological samples for healthy relatives|Blood samples.
15989414|NCT02967809|Device|echography|cardiac and pulmonary echography
15989415|NCT02967796|Dietary Supplement|Proteochoc|
15989416|NCT02967783|Device|ID adaptor|ID adaptor fixed to the end of a standard ID needle and syringe to facilitate ID administration of the inactivated poliovirus vaccine
15989417|NCT02967783|Device|ID Jet Injector (Tropis, Pharmajet)|ID disposable syringe (needle free) jet injector to facilitate ID administration of the inactivated poliovirus vaccine
15989418|NCT02967783|Device|Needle and syringe|Standard ID needle and syringe for ID administration of the inactivated poliovirus vaccine
15989419|NCT02967770|Other|Molecularly Tailored Second Line Therapy|This trial is designed to assess the efficacy of MTT vs. SOC therapy as second-line therapy in patients with metastatic pancreatic cancer.
15989420|NCT02967770|Drug|Standard of Care Second Line Therapy|
15989421|NCT02967757|Drug|liraglutide|Patients will be treated according to routine clinical practice at the discretion of the treating physician. The study will gather data over the course of routine treatment for liraglutide 3.0 mg and liraglutide 1.2 mg/1.8 mg treated patients
15989422|NCT02967744|Drug|NSAID|NSAIDs are among the most common pain treatments for patients with osteoarthritis.
15989423|NCT02967731|Drug|480 Mometasone Furoate Sinus Drug Depot|Management of Chronic Sinusitis
15989424|NCT02967705|Behavioral|Pain management group|Chronic pain patients participate in a peer group. They are provided information about chronic pain self-management based on biopsychosocial framework.
15989425|NCT02967692|Biological|Spartalizumab (PDR001)|Spartalizumab (PDR001) will be supplied in vial in liquid or lyophilized pharmaceutical form. Spartalizumab (PDR001) will be administered via intravenous infusion over 30 minutes (up to 2 hours) once every 4 or 8 weeks.
15989426|NCT02967692|Other|Placebo|Placebo will be a Dextrose 5% in water (D5W) infusion supplied by the site.
15989427|NCT02967692|Drug|Dabrafenib|Dabrafenib will be provided by the sponsor to the investigative site or supplied locally as commercially available. Dabrafenib will be administered orally twice daily (150 mg BID) for Days 1-28 of a 28-day cycle.
15989428|NCT02967692|Drug|Trametinib|Trametinib will be provided by the sponsor to the investigative site or supplied locally as commercially available. Trametinib will be administered orally once daily (2 mg QD) for Days 1-28 of a 28-day cycle.
15989429|NCT02967679|Drug|MD1003|
15989430|NCT02967666|Radiation|FDG ligand|
15989431|NCT02967666|Radiation|DOTANOC ligand|
15989432|NCT02967653|Drug|Atorvastatin|Member of drug class called statins, primarily used as a lipid-lowering agent and the prevention of events associated with cardiovascular disease
15989464|NCT02967380|Drug|Gadobutrol|Given IV
15989465|NCT02967380|Radiation|Gadopentetate Dimeglumine|Given IV
15989433|NCT02967640|Drug|Ketalar|2,5 ml - if well tolerated immediately followed by another 2,5 ml - of an approximately 1 mg/ml ketalar solution (1 ml of ketalar 10 mg/ml + 9 ml of NaCl 9%) injected 2 times with 1-12 weeks between each injection
15989434|NCT02967640|Drug|NaCl 9%|2,5 ml - if well tolerated immediately followed by another 2,5 ml - of a 9% NaCl solution injected 2 times with 1-12 weeks between each injection
15989435|NCT02967627|Device|Incisional Negative Pressure Wound Therapy (iNPWT)|Incisional Negative Pressure Wound Therapy devices are lightweight, self contained, portable battery powered (or line powered), suction pumps for medical procedures where secretions and other body fluids and infectious materials must be removed through the application of continuous or intermittent negative pressure. The pumps are operated through computer software, having help and alarm features. The device is indicted for management of chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The pumps may be used at patient's bedside. These are suitable for use in either hospitals or long term care facilities and nursing homes. These devices will be applied to closed laparotomy incisions with the aim to provide three days of continuous negative pressure of - 100mmHg.
15989436|NCT02967627|Device|Sterile Gauze Dressing|In most cases, self-adhesive, absorbent dressings will be used for standard wound therapy. However, surgical teams may decide on alternative forms of sterile gauze dressings, as long as the wound site is kept clean and dry. Dressings should be taken down on the second post-operative day.
15989437|NCT02967614|Drug|[A]|One eye drop(about 40ul) / Day1 ~ Day8 / BID
15989438|NCT02967614|Drug|[B]|One eye drop(about 40ul) / Day1 ~ Day92 / BID
15989439|NCT02967614|Drug|[A]+[B](1)|One eye drop(about 40ul) / Day9 ~ Day100 / BID
15989440|NCT02967614|Drug|[A]+[B](2)|One eye drop(about 40ul) / Day93 ~ Day100 / BID
15989441|NCT02967601|Behavioral|STAI (State Trait Anxiety Inventory) questionaire|Each patient would fill the STAI questionaire before Cesarean Section (on the same day, in the morning)
15989442|NCT02967588|Behavioral|Intervention group|"All stages of the intervention will take place during hospitalization. Patients will complete a questionnaire about their personal beliefs about medicines. Patients responses to this questionnaire will form the basis of Session 1 where beliefs about medicines will be discussed. Any negative beliefs or concerns will be discussed and beliefs about drug necessity will be encouraged.
~Session 2 will focus on developing specific action plans for taking medication at home. Patients will be asked to formulate an if-then plan ('If it is time X in place Y and I am doing Z, then I will take my pill dose').
~Prior to discharge, patients will complete the beliefs questionnaire again to see if there has been any shift in their beliefs about medications. Patients will also be asked to provide detailed feedback about the study. The investigators want to know whether the intervention setting, timing, content and delivery method seem to be acceptable to patients."
15989443|NCT02967575|Device|cTDR|"The surgical procedure for the Triadyme-C total disc replacement corresponds to the standard surgical technique for cTDR:
~Implantation through a standard anterior cervical approach
~Midline identification
~Routine discectomy with endplate preparation and decompression
~Implant sizing and trial implantation
~Keel preparation
~Implant preparation and loading of the appropriate Triadyme-C implant
~Triadyme-C insertion, positioned as close to the midline as possible"
15989444|NCT02967562|Other|Inflation Breaths|
15989445|NCT02967562|Other|Sustained Inflation|
15989446|NCT02967549|Device|NAVA|NAVA delivered by the Servo-n ventilator (Maquet)
15989447|NCT02967549|Device|PAV|PAV delivered by the Stephanie ventilator (Stephan)
15989448|NCT02967523|Device|DEB-TACE with Surefire Precision Infusion System|Subjects have undergone/will undergo DEB-TACE using the Surefire Precision Infusion System.
15989449|NCT02967510|Drug|Estriol|
15989450|NCT02967510|Drug|Placebo|
15989451|NCT02967497|Drug|YQ1|Oral administered powder
15989452|NCT02967484|Device|acupuncture|"Huo Xue San Feng acupuncture method: Patients will recieve the acupuncture treatment,choose the bilateral point:Renying(ST9),Hegu(L14),Taichong(LR3),Quchi(LI11),Zusanli(ST36).
~Routine care for ischemic stroke :patients will recieve the acupuncture treatment,choose the point:Neiguan(PC6),Renzhong(10),Sanyinjiao(SP6),Jiquan(HT1),Chize(LU5),Weizhong(BL40).
~Drugs: Antihypertensive drugs.Patients will be treated 1 of 5 type of antihypertensive drugs,include ARB、ACEI、βreceptor blocker,CCB,Diuretic.
~The time of therapy will consist of 6 times per week in Continuous treatment phase(1st-6th week after enrollment) and 3 times per week(once every other day) in Consolidation treatment phase(7th-tewlve week after enrollment)"
15989453|NCT02967458|Drug|Perflutren Lipid Microsphere Intravenous Suspension|The intravenous administration of Perflutren Lipid Microsphere will provide enhancement of vascular tissue when performing subharmonic prostate ultrasound imaging. This enhancement will be used to guide targeted biopsy of the prostate to vascular areas which are more likely to contain aggressive prostate cancer.
15989454|NCT02967445|Device|Arabin Pessary|Arabin silicon pessary
15989455|NCT02967445|Device|Cervical cerclage|
15989456|NCT02967432|Drug|Mupirocin Topical Ointment|Mupirocin ointment 1/2 inch ribbon applied topically to each nare and umbilicus twice daily for 5 days; repeat treatment courses possible.
15989457|NCT02967432|Drug|Petroleum Jelly|Petroleum jelly ointment 1/2 inch ribbon applied topically to each nare and umbilicus twice daily for 5 days; repeat treatment courses possible.
15989458|NCT02967419|Other|No Intervention|
15989459|NCT02967406|Behavioral|4 x 4 lifestyle modification|Participants in the intervention group will be given 4x4 lifestyle modification intervention, which will address four health behaviors (diet, physical activity, alcohol drinking and smoking) at four different levels: individual, household, knowledge management and community levels. A new computer program called 'iActive' adapted from the GPAQ with add-on functions to allow real-time assessment and presentation of the energy expenditure along with recommendations specific to each individual will be used. Dietary counseling will be given individually following assessment using a new dietary assessment program called Dietary Assessment Scanning Calculator. Home visit will be done every 3 months by responsible nurses and village health volunteers. Knowledge management will be done through meetings between participants and villages with support from trained nurses. Situation analysis and community action will be encouraged to address four health behaviors.
15989460|NCT02967393|Drug|ccIIV4|
15989461|NCT02967393|Drug|IIV4|
15989462|NCT02967380|Procedure|Dynamic Contrast-Enhanced Magnetic Resonance Imaging|Undergo DCE-MRI
15989463|NCT02967380|Drug|Gadobenate Dimeglumine|Given IV
15989466|NCT02967367|Device|Jawbone sleep tracker|During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
15989467|NCT02967367|Device|Withings sleep tracker|During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
15989468|NCT02967367|Device|BodyMedia Sense Wear accelerometer|During one night of polysomnographic recording, investigators are going to place these 3 accelerometers on the wrist of the patient
15989469|NCT02967354|Radiation|Positron emission tomography with the tracer [11C]5-hydroxy-tryptophan|Estimation of islet mass by PET using the tracer [11C]5-hydroxy-tryptophan
15989470|NCT02967341|Other|Ciprofloxacin administration|Ciprofloxacin will be administered via the PAC directly followed by a NaCl 0.9% flush to wash the PAC. At least 1 hour afterwards 500 microliter of blood will be drawn via the PAC. Directly hereafter a blood draw of 500 microliter will be performed either via capillary blood sampling or via a venipuncture. If an anaesthesia is foreseen for another procedure (e.g. a lumbar puncture or an osseous punction), we will strive to perform the peripheral blood draw under anaesthesia.
15989471|NCT02967328|Other|RP% Measurement by FCM as a Diagnostic Test for ITP|
15989472|NCT02967315|Procedure|Cardiac Magnetic Resonance Imaging (CMRI)|"There will be 2 CMRIs. The first one will be patient's routine clinically schedule CMRI after the patient has fasted for 12 hours.This CMRI uses contrast.
~The second CMRI will be the research CMRI after the fluid administration. This CMRI does not use contrast."
15989473|NCT02967315|Procedure|Central venous line placement|An ultrasound guided central line catheter will be placed in the internal jugular vein (IJV) under local anesthesia.
15989474|NCT02967315|Procedure|Chest X-ray|A chest X-ray will be performed for safety reasons to rule out pneumothorax (< 1% risk) after central line placement.
15989475|NCT02967315|Procedure|Fluid administration|Administration of 15cc/kg of normal saline for fluid hydration through peripheral IV that is placed for the MRI contrast administration.
15989476|NCT02967315|Procedure|Blood Draw|One to two teaspoons of blood will be drawn for basic metabolic panel.
15989477|NCT02967315|Procedure|Pregnancy test|A urine pregnancy test will be performed in female subjects.
15989478|NCT02967315|Procedure|Electrocardiogram|12 lead ECG
15989479|NCT02967302|Drug|Morphine Sulfate|active intervention
15989480|NCT02967302|Drug|Triamcinolone|active control
15989481|NCT02967302|Drug|placebo|placebo control
15989482|NCT02967289|Drug|Irinotecan|every 14 days, 12 cycles, 24 weeks, new cycle beginning on day 15: irinotecan (Campto®) 180 mg/m² on D1, IV infusion over 90 minutes to begin 30 min after folinic acid infusion is started
15989483|NCT02967289|Drug|Folfox Protocol|every 14 days, 12 cycles, 24 weeks, new cycle beginning on day 15: oxaliplatin (Eloxatin®) 85 mg/m² on D1, IV infusion over 2 hours, followed by folinic acid 400 mg/m² (racemic mixture) (or 200 mg/m² if L-folinic acid) IV infusion over 2 hours 5-FU 2400 mg/m²/h IV continuous infusion over 46 hours starting at the end of folinic acid infusion
15989484|NCT02967276|Drug|Metformin XR|500 mg tablet: They take 1-5 tablets of 500 mg after dinner. Starting dose of Metformin XR 500 mg. It will have an increase of 500 mg/day each week up to the maximum tolerance from the 2500 mg / day, during the 6 cycles.
15989485|NCT02967276|Drug|Dexamethasone|4 mg tablet: Patients will use 40 mg per day. They take 5-10 tablets 4mg after breakfast and lunch. Patients over age 75 will use 20 mg / day.
15989486|NCT02967250|Drug|ursodeoxycholic acid|Subjects will be provided ~50mg/kg/day (based on the use of 250 and 500mg capsules) of UDCA to be divided into 3 equal daily doses and titrated up over ~2 weeks to a stable dose for 4 weeks.
15989487|NCT02967237|Drug|insulin glargine (U300)|Pharmaceutical form: solution Route of administration: subcutaneous
15989488|NCT02967224|Drug|insulin glargine (U300)|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
15989489|NCT02967224|Drug|insulin glargine (U100)|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
15989490|NCT02967224|Drug|NPH insulin|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
15989491|NCT02967224|Drug|insulin detemir|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
15989492|NCT02967224|Drug|insulin degludec|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
15989493|NCT02967211|Drug|insulin glargine (U300)|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
15989494|NCT02967211|Drug|insulin glargine (U100)|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
15989495|NCT02967211|Drug|NPH insulin|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
15989496|NCT02967211|Drug|insulin detemir|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
15989497|NCT02967211|Drug|insulin degludec|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
15989498|NCT02967198|Device|CT/US fusion|Fusion of pre-procedure cross-sectional imaging (CT or MRI) and real-time USG using registration function of USG device.
15989499|NCT02967198|Device|ultrasound shear wave elastography|ultrasound shear wave elastography is performed in S-shear wave scanner according to guidelines of ultrasound elastography.
15989500|NCT02967185|Behavioral|Brief Behavioral Therapy for Insomnia|Treatment will consist of 4 weekly, 1 hour sessions and will be conducted by a trained graduate assistant on an individual basis. Treatment components will include education about aging and sleep. It will also include instruction in techniques designed to: (a) promote good sleep habits, (b) restrict the use of the bed and bedroom to sleep and sleep-conducive activities, (c) modify bed and wake times to better match the participants sleep needs, and (d) promote relaxation. Daily home practice of these techniques will be encouraged. Participants will maintain logs of their home practice sessions and will continue to record their daily sleep habits throughout treatment.
15989501|NCT02967172|Drug|Ropivacaine|
15989502|NCT02967172|Drug|Epinephrine|
15989503|NCT02967172|Drug|Morphine|
15989504|NCT02967172|Drug|0.9% sodium chloride solution|
15989505|NCT02967159|Drug|Abediterol|Treatment A: Abediterol 2.5 μg via DPI
15989506|NCT02967159|Drug|AZD7594|Treatment B: AZD7594 440 μg via DPI
15989507|NCT02967159|Drug|AZD7594/abediterol|Treatment C: AZD7594/abediterol 440 μg/2.5 μg FDC via DPI
15989508|NCT02967159|Drug|AZD7594 and abediterol|Treatment D: AZD7594 440 μg and abediterol 2.5 μg free combination administered via 2 separate DPIs
15989509|NCT02967146|Device|adhesive barrier|After having axillary dissection, investigator has to inject the mediclore on op site directly and suture the site.
15989510|NCT02967133|Drug|Nivolumab|"Arm A: Nivolumab 240 mg via intravenous infusion (IV) over 30 minutes day 1 of each 14 day cycle until disease progression or not tolerated.
~Arm B: Nivolumab 360 mg via intravenous infusion (IV) over 30 minutes day 1 of every 21 day treatment cycle until progression or not tolerated."
15989511|NCT02967133|Drug|nab-paclitaxel|Patients in arm B receive nab-paclitaxel at a dose of 100 mg/m2 over intravenous infusion on Days 1 and 8 of each 21 day cycle.
15989512|NCT02967120|Other|no intervention|
15989513|NCT02967107|Procedure|Cold snare polypectomy|Use of a polypectomy snare closed over a polyp without electrocautery
15989514|NCT02967107|Procedure|Endoscopic mucosal resection|Use of injected chromogelofusine solution to raise a lesion prior to snare resection with electrocautery
15989515|NCT02967094|Drug|Administration of mucolytic solution before upper endoscopy (Espumisan, ACC long)|
15989516|NCT02967094|Drug|Administration of water before upper endoscopy|
15989517|NCT02967081|Procedure|Collection of dentinal fluid using a cellulose membrane|After removal of the caries lesion/filling a cellulose membrane (sterile paper point) will be applied with its blunt end to the dentin for 1 min to collect dentinal fluid.
15989518|NCT02967042|Device|18F-PET-TT|can 18F-PET-TT be used as an diagnostic tool in patients with CKD-MBD
15989519|NCT02967029|Drug|Esmolol Hydrochloride|the influence of brevibloc as a hypotensive agent on rSO2
15989520|NCT02967029|Drug|Remifentanil Hydrochloride|the influence of remifentanyl as a hypotensive agent on rSO2
15989521|NCT02967016|Behavioral|Actigraph|following delivery a ActiGraph will be offered to patients to track their steps
15989522|NCT02966990|Device|Hand Orthotic Devices|Orthotic device made to provide the patient with better hand function
15989523|NCT02966977|Other|Conventional microbiological identification by culture plate|Conventional microbiological identification involves a step of overnight-2days growth of bacteria/fungi on culture plates prior to identification by biochemical methods or by mass spectrometry. See also information noted in arm/group description.
15989524|NCT02966977|Other|Direct mass spectrometry identification from urine sample|The urine sample is concentrated and directly measured by a MALDI-TOF mass spectrometer without an intermediary microbiological culture on agar plates.
15989525|NCT02966964|Drug|DWPUR001|
15989526|NCT02966964|Drug|Placebo|
15989527|NCT02966951|Biological|Adipose tissue derived mesenchymal stem cell|Intra-articular adipose tissue derived mesenchymal stem cell injection.
15989528|NCT02966925|Device|Cellular Matrix BCT-HA Kit|Submucosal injections in the vulva, in the posterior vaginal wall and in the perineum of a combination product made of PRP and HA prepared using the Cellular Matrix BCT-HA medical device
15989529|NCT02966912|Dietary Supplement|400 mg of Magnesium Oxide twice daily for 24 weeks|
15989530|NCT02966912|Other|Open label (none)|
15989531|NCT02966899|Dietary Supplement|Omega-3 fatty acids|
15989532|NCT02966886|Procedure|Eccentric Reaming|"Pre-operative CT imaging and surgical planning software based on pre-operative CT scans will be used in each case to determine the degree of eccentric (high side) anterior reaming to within < 10 degrees of neutral glenoid version."
15989533|NCT02966886|Procedure|Augmented Glenoid Component Implantation|Patients will undergo standard glenoid preparation and implantation of a posteriorly augmented glenoid component. The degree of posterior augment will be based on pre-operative CT scan assessment and templating software with the goal of correcting glenoid retroversion to within 10 degrees of neutral version.
15989534|NCT02966886|Procedure|Posterior Glenoid Bone Grafting|Patient will undergo a total shoulder arthroplasty as per standard technique. Glenoid version will be restored to within 10 degrees of neutral with a posterior glenoid bone graft. The bone graft will be harvested from the humeral head and fixed to the posterior glenoid with mini-fragment screws.
15989535|NCT02966873|Drug|N-Acetylcysteine (NAC) Treatment|Participant will receive 12 weeks of Active Treatment NAC (2400 mg) daily. The study medication will be provided in blister packs in the form of 600 mg tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.
15989536|NCT02966873|Behavioral|Cognitive Behavioral Therapy|Participant will receive 12 weeks of weekly cognitive-behavioral therapy, medication management, and AE monitoring.
15989537|NCT02966873|Drug|Placebo Oral Capsule|Participant will receive 12 weeks of inactive placebo. The study medication will be provided in blister packs in the form of 600 mg tablets. Each participant will be asked to take two (2) 600 mg tablets in the morning and two (2) 600 mg tablets in the evening.
15989538|NCT02966860|Drug|Oral solution OC/APAP|
15989539|NCT02966847|Procedure|CBCT acquisition|Acquisitions are performed with the DynaCT function of a C-arm Artis Zeego System® device
15989540|NCT02966847|Procedure|Anesthesia and surgery|The anesthesia and surgery will take place according clinical routine practice
15989541|NCT02966834|Drug|Placebo|GSK2330672 matching placebo will be supplied as white film-coated tablets.
15989542|NCT02966834|Drug|GSK2330672|GSK2330672 will be supplied in 2 dose strengths of 10 mg and 45 mg white film-coated tablets.
15989543|NCT02966821|Drug|Surufatinib|Patients receive oral Surufatinib at a dose of 300mg/d within 1 hour after breakfast (once-daily dosing continuously, every 28-day treatment cycle)
15989544|NCT02966808|Behavioral|cognitive and behavioural questionnaires|
15989545|NCT02966795|Drug|Glecaprevir/Pibrentasvir|Fixed-dose combination tablets taken orally once a day.
15989546|NCT02966782|Drug|venetoclax|Tablet
15989547|NCT02966782|Drug|azacitidine|Powder for injection, subcutaneously or intravenous
15989548|NCT02966769|Other|Overall survival|Compare overall survival between both groups.
15989549|NCT02966756|Drug|Venetoclax|Tablet; Oral
15989550|NCT02966743|Drug|Midazolam|administration of midazolam during spinal anesthesia for target bispectral index 75-80
15989551|NCT02966743|Drug|Dexmedetomidine|administration of dexmedetomidine during spinal anesthesia for target bispectral index 75-80
15989552|NCT02966730|Drug|Ibrutinib|Ibrutinib will be administered orally, on a once daily continuous dosing schedule and in an outpatient setting. Treatment will continue for 2 years and there will be no planned treatment breaks. The dose of Ibrutinib will be initiated at 560mg per day, which will remain constant throughout the study period, unless otherwise specified.
15989553|NCT02966717|Drug|Rituximab|Rituximab is a human-mouse-chimeric monoclonal antibody which was approved in 1997 for the treatment of cancer.
15989554|NCT02966717|Drug|conventional therapy|Intervention of conventional therapy group: controlling blood pressure using amlodipine, valsartan, metoprolol and terazosin and so on , protecting the renal function using bailing capsule, alpha keto acid, low molecular weight heparin and so on.
15989555|NCT02966717|Drug|Mesenchymal stem cells|Mesenchymal stem cells (MSCs), which belongs to mesoderm, is a kind of somatic stem cell with the ability of self-replication and the potential of multi-directional differentiation.
15989556|NCT02966704|Dietary Supplement|intrinsically labeled milk protein|
15989557|NCT02966691|Other|VisioCyt® diagnostic test|The cytology slides obtained from the current practice will be compared to the slides obtained with the Visiocyt protocol, for each arm.
15989558|NCT02966678|Procedure|Color Vision Test|Farnsworth Panel D15/Hue test plus Ishihara charts
15989559|NCT02966665|Other|Maximum Exercise Tests|Graded exercise test to volitional exhaustion (stationary bike or treadmill), maximal handgrip test, maximal leg extension test, and maximal plantar flexion test.
15989560|NCT02966665|Drug|BH4, L-NMMA, Vitamin C, Vitamin E, α-Lipoic Acid and L-Ascorbate|Catheter placement in femoral artery and femoral vein; resting measurements of blood pressure, heart rate and blood flow; flow mediated vasodilation test, passive leg movement test, exercise bouts, electromyography and exercise training regimen at baseline and following treatment with Nitric Oxide blockade via infusion of N-monomethyl-L-arginine (L-NMMA) (0.4 mg/kg/min), antioxidant cocktail (Vitamin C, Vitamin E, alpha-lipoic acid) ingestion, L-ascorbate injection, BH4 ingestion.
15989561|NCT02966665|Drug|BQ-123|Catheter placement in femoral artery and femoral vein; resting measurements of blood pressure, heart rate and blood flow; flow mediated vasodilation test and exercise bouts at baseline and following treatment with endothelin-1 receptor antagonist BQ-123 (D-tryptamine-D-aspartic acid-L-proline-D-valine-L-leucine).
15989562|NCT02966665|Drug|Fexofenadine, Ranitidine|Catheter placement in femoral artery and femoral vein; resting measurements of blood pressure, heart rate and blood flow; flow mediated vasodilation test and exercise bouts at baseline and following treatment with Histamine H1 receptor antagonist fexofenadine (Allegra) and Histamine H2 receptor antagonist ranitidine (Zantac).
15989563|NCT02966665|Other|Angiotensin-II, Valsartan|Catheter placement in femoral artery and femoral vein; resting measurements of blood pressure, heart rate and blood flow; flow mediated vasodilation test, muscle sympathetic nerve activity measurement, and exercise bouts at baseline and following treatment with Angiotensin-II receptor agonist (angiotensin-II) and antagonist Valsartan (Diovan).
15989564|NCT02966665|Drug|Acetylcholine, Sodium Nitroprusside, Angiotensin-II, Norepinephrine, Phentolamine|Catheter placement in femoral artery and femoral vein; resting measurements of blood pressure, heart rate and blood flow; flow mediated vasodilation test, muscle sympathetic nerve activity measurement; vasodilation with nitroglycerin followed by Angiotensin-II and Alpha Adrenergic blockade with infusions of Acetylcholine, Sodium Nitroprusside, Angiotensin-II, Norepinephrine and Phentolamine (Regitine).
15989565|NCT02966665|Drug|BQ-123, MitoQ, BH4|Catheter placement in femoral artery and femoral vein and muscle biopsy; Nuclear Magnetic Resonance (NMR) scanning and exercise bouts at baseline and following treatment with BQ-123 with or without oral mitochondria-targeted antioxidant (MitoQ) or oral BH4.
15989566|NCT02966652|Drug|DITEST|Lipid formulation of native oral testosterone.
15989567|NCT02966652|Drug|Testosterone undecanoate|Generic treatment for patients with primary or secondary male hypogonadism
15989568|NCT02966613|Device|GMK Medacta Total Knee arthroplasty|Total Knee arthroplasty
15989569|NCT02966600|Other|Progressive resistance exercise|The intervention group participated in sixteen PRE training sessions for eight weeks: two sessions per week on non-consecutive days, sixty-seventy min each one.
15989570|NCT02966600|Other|Physical Activity|The control group followed its usual weekly physical activity routine
15989571|NCT02966587|Biological|Durvalumab|Given IV
15989572|NCT02966587|Other|Laboratory Biomarker Analysis|Correlative studies
15989573|NCT02966574|Device|whole body MRI|The examination will be conducted in the pretreatment assessment of breast cancers with a high metastasis risk and in the monitoring of metastatic breast cancers. The examination is performed without intravenous injection of contrast medium, from the top of the skull to mid-thigh using diffusion weighted sequences in the axial plane, T1-weighted sequences in the coronal plane, STIR T2 weighted sequences in the coronal plane and T1-weighted sequences in the sagittal plane on the spine. Total examination duration is one hour. The interpretation of the results is made by two independent reporters with a complementary expertise, according to a systematic lecture grid.
15989574|NCT02966561|Behavioral|Pedometer-based activity promotion|"The central components of the 2 x 45 minutes lasting pedometer-based physical activity behaviour change intervention BCI are the following behaviour change techniques (BCTs):
~Instruction on how, where and when to perform the behaviour
~Prompt goal setting for physical activity
~Prompt self-monitoring of behaviour
~Feedback on behaviour. Participants receive a pedometer and a booklet with a physical activity diary and associated information on the importance of goal setting and keeping a physical activity diary, exercise recommendations, possibilities to stay active after rehabilitation and appropriate physical activities."
15989575|NCT02966561|Behavioral|Short patient education and exercise|"The central components of the 2 x 45 minutes lasting intervention are revisions of knowledge of the pulmonary rehabilitation (standard care) in combination with related exercises:
~Revision of knowledge on exercise recommendations
~Revision of knowledge on possibilities of self-regulation of endurance training exercise intensity with the rate of perceived exertion (BORG-Scale)
~Revision of self-regulation of endurance exercise intensity
~Revision of strengthening activities consistent with the exercise recommendations.
~Participants receive a booklet with information on the rate of perceived exertion, exercise recommendations, possibilities to stay active after rehabilitation and appropriate physical activities."
15989617|NCT02966249|Drug|Normal Saline intrathecally|0,5 ml Normal Saline given intrathecally given once for spinal anesthesia in total knee arthroplasty
15989618|NCT02966249|Drug|Ringer's Lactate solution intravenously|Continuous infusion of Ringer's Lactate solution given intravenously, starting 10 minutes before spinal anesthesia up to the end of the operation
15989619|NCT02966249|Drug|Dexmetomidine intrathecally|5 μgr dexmetomidine given intrathecally once for anesthesia in total knee replacement
15989620|NCT02966236|Drug|Tranexamic Acid|
15989621|NCT02966236|Drug|Placebos|
15989576|NCT02966561|Other|Pulmonary rehabilitation (Standard care)|Standard care is an in-patient pulmonary rehabilitation (PR) in a specialized German Rehabilitation Clinic. PR is a comprehensive, multidisciplinary intervention based on a patient assessment followed by a combination of patient-tailored therapies. PR lasts on average 25 days. PR includes the following obligatory main components: Checking and, if required, adjusting the current COPD medication according to current COPD-guidelines; physical training (4-5 units/week endurance training [45 min] and 3 units/week of strength training [45 min] per week, 7 units/week whole body vibration muscle training/week); structured COPD-patient education (6 hours patient education COPD + 1 hour device training); respiratory physiotherapy in groups [2-4 units/week with 45 min]. PR is implemented by an interdisciplinary rehabilitation team.
15989577|NCT02966548|Drug|Relatlimab|Specified dose on specified days
15989578|NCT02966548|Drug|Nivolumab|Specified dose on specified days
15989579|NCT02966535|Device|Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:2 to 1:1)|Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:2 to 1:1)
15989580|NCT02966535|Device|Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:1 to 1:2)|Adjustment of Mechanical Ventilator Inspiratory to expiratory time ratio (1:1 to 1:2)
15989581|NCT02966522|Drug|Thalidomide|
15989582|NCT02966522|Drug|Dexamethasone|
15989583|NCT02966509|Behavioral|EPAC|Each patient will receive a lay health worker who will engage and educate patients on goals of care documentation and will continue to address goals of care for at least 6 months with patients after enrollment in the study.
15989584|NCT02966496|Biological|Acri.LISA366D multifocal aspheric IOLs|The implantation of Acri.LISA366D multifocal aspheric IOLs are used in the test group.
15989585|NCT02966496|Biological|TecnisZ9001 multifocal aspheric IOLs|The implantation of TecnisZ9001 multifocal aspheric IOLs are used in the test group.
15989586|NCT02966483|Procedure|TaTME|Transanal Total Mesorectal Excision
15989587|NCT02966483|Procedure|LpTME|Conventional Laparoscopic Total Mesorectal Excision
15989588|NCT02966470|Device|Obtain grip strength from a standardized gripometer|Obtain grip strength from a standardized gripometer, 3 times on each hand
15989589|NCT02966457|Drug|Colistimethate Sodium|Selective oral intestinal decolonization
15989590|NCT02966444|Other|MUFA-rich HF Meal|
15989591|NCT02966444|Other|PUFA-rich HF Meal|
15989592|NCT02966444|Other|SFA-rich HF Meal|
15989593|NCT02966431|Behavioral|Counseling|
15989594|NCT02966431|Behavioral|No Counseling|
15989595|NCT02966418|Procedure|Mild Hypoxia Preconditioning|Patients will be treated with mild hypoxia ( Note: The oxygen concentration decreased from 20% to 18%, and keeping at 18%)×7 days，twice a day in the morning and in the afternoon before surgery.
15989596|NCT02966418|Procedure|Sham preconditioning|Patients will be treated with sham preconditioning (oxygen concentration: 21％) ×7 days，twice a day in the morning and in the afternoon before surgery.
15989597|NCT02966392|Device|Tracoe cuff pressure controller|Participant will be attached to the cuff pressure controller as soon as possible after enrolment. They will remain attached during their intubated stay. If reintubated during same admission they will continue in the intervention arm. If readmitted to ICU they will be managed according to standard care.
15989598|NCT02966379|Device|cochlear implantation|"Surgery is standardized in order to have the same procedure for all patients and to preserve a maximum of residual hearing:
~Corticosteroïds (1mg/kg solumedrol) at anesthetic induction ,
~mastoidectomy + posterieur tympanostomy ,
~insertion through round window,
~stop at the first resistance point"
15989599|NCT02966366|Device|Cochlear implant|
15989600|NCT02966353|Drug|ruxolitinib|Ruxolitinib was supplied in 5 mg tablets to be taken orally approximately 12 hours apart (morning and night)
15989601|NCT02966340|Drug|Prazosin|2mg Prazosin
15989602|NCT02966340|Drug|Placebo|Placebo
15989603|NCT02966327|Device|Bilateral leg compression stockings|Prescribed Jobst Elvarex compression class 1 (18 to 21 mmHg) standard or custom-made stockings for both lower limbs with or without panty; participants will be recommended to wear the garments for 12 to 16 hours daily for at least 6 months post-operatively.
15989604|NCT02966327|Behavioral|Individualized exercise|Individualized education on exercise according to the Canadian Physical Activity Guidelines and self-lymphatic drainage techniques
15989605|NCT02966327|Behavioral|Lymphedema risk reduction|Standard education on lymphedema risk reduction along with printed materials from the Lymphedema Association of Quebec
15989606|NCT02966314|Drug|Omalizumab|Omalizumab 300mg subcutaneous injection once monthly for 6 months. Total dose will be divided into two 150mg/1.2mL injections.
15989607|NCT02966314|Drug|Placebos|Placebo Group (Sodium Chloride 0.9%) two 1.2mL subcutaneous injections once monthly for 6 months.
15989608|NCT02966301|Drug|Arsenic Trioxide Injectable Solution|"Each patient will receive eleven perfusions of arsenic trioxide (0,15 mg/kg/Day - IV administration) over a 4 weeks period (one cycle).
~Patients in partial response after the 1st cycle of ATO will be eligible to receive a second cycle of ATO as consolidation therapy. A delay of 8 weeks (from the first infusion of ATO) will be observed between the two cycles of ATO therapy.
~The study duration will be 2 years (12 months recruitment + 12 months follow-up)."
15989609|NCT02966288|Drug|Toradol|3-ml solution that contains 2 ml of normal saline and 1 ml of Toradol, 30 mg, will be infused into the affected joint.
15989610|NCT02966288|Drug|Oral NSAID|800mg Motrin will be administered. (non-steroidal anti-inflammatory drug (NSAID))
15989611|NCT02966275|Device|Glucagon-only bionic pancreas - glucagon|A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.
15989612|NCT02966275|Device|Glucagon-only bionic pancreas - placebo|A computer algorithm will automatically deliver placebo based on the signal from a minimally invasive continuous glucose monitor.
15989613|NCT02966262|Device|Optical coherence tomography|Intracoronary imaging device which can precisely observe intracoronary structures
15989614|NCT02966249|Drug|Levobupivacaine|3 ml Levobupivacaine 0.5% (15mg) given intrathecally
15989615|NCT02966249|Drug|Dexmetomidine intravenously|Continuous infusion of dexdemetomidine at a rate of 0.25 μg/kg/h given intravenously 10 min before spinal anesthesia in total knee arthroplasty
15989616|NCT02966249|Drug|Normal Saline added intrathecally|Normal Saline added to 5μgr dexmetomidine up to 0,5 ml given intrathecally for spinal anesthesia in total knee arthroplasty
15989622|NCT02966223|Radiation|MRI and HIDA scan|Pre y90 therapy each subject will undergo a HIDA and MRI scan. 3 months post Y90 - Each subject will undergo a second HIDA scan and MRI scan
15989623|NCT02966197|Procedure|prophylactic internal iliac artery balloon catheterization|Between June 2015 and August 2016
15989624|NCT02966197|Device|Prophylactic internal iliac artery balloon|
15989625|NCT02966197|Radiation|Radiology operation|
15989626|NCT02966184|Drug|preservative free albuterol|Preservative free albuterol for nebulization
15989627|NCT02966171|Drug|HMPL-453|oral administration
15989628|NCT02966158|Other|AIT Group|"The AIT Group will begin with a one-month, run-in period where patients will perform current standard of care CR programming, which will involve traditional MICE. MICE at the Cardiac Rumsey Centre will consist of either track walking/jogging or treadmill walking/jogging for approximately 30-40 minutes, performed at an intensity of 60-80% of VO2peak, in addition to a warm-up and cool down period. In the second month of the study intervention, patients will begin to perform AIT three days per week, which involves performing 4-minute intervals at greater than 90% of peak heart rate, separated by 3-minutes of active recovery, with one of those AIT exercise sessions occurring at the Rumsey Centre under supervision, and 2 sessions per week of MICE, which will again consist of the 30-40 minutes of walking/jogging at an intensity of 60-80% of VO2peak, with an allotted warm up and cool down period."
15989629|NCT02966145|Other|Observational Study|
15989630|NCT02966132|Behavioral|iMD|Interactive video education delivered on a tablet computer
15989631|NCT02966132|Behavioral|NPA|
15989632|NCT02966119|Drug|Clopidogrel or Aspirin and/or Dypyridamole|"The physician will prescribe on this antiplatelet agent if the patient is randomized in the arm  restart"
15989633|NCT02966106|Device|Right prefrontal low frequency rTMS|A treatment session each day in four weeks apart from weekends. Each session is administered with 2 pulse trains of 180 sec with a 2 min interval
15989634|NCT02966106|Other|Sham-rTMS|Right prefrontal rTMS sham treatment. A treatment session each day in four weeks apart from weekends. Each session is administered with 2 pulse trains of 180 sec with a 2 min interval
15989635|NCT02966093|Drug|Lenvatinib|Participants will received lenvatinib 24 mg (two 10-mg capsules + one 4-mg capsule) orally, once daily continuously in 28-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
15989636|NCT02966093|Drug|Placebo|Participants will received lenvatinib matched placebo (two 10-mg capsules + one 4-mg capsule) orally, once daily continuously in 28-day cycles until disease progression, development of unacceptable toxicity, withdrawal of consent, or study termination by sponsor.
15989637|NCT02966080|Drug|HEP-IV|
15989638|NCT02966067|Device|Microneedle Device (Experimental)|Injection of 1.2ml of a standard local dental anaesthetic solution [1.2ml of 2% lidocaine and 1:80,000 epinephrine (lidocaine 20 mg/ml, epinephrine 12.5 mμ/ml)] at a rate of 1 mL/min.
15989639|NCT02966067|Device|30-gauge Short Hypodermic Needle|Injection of 1.2ml of a standard local dental anaesthetic solution [1.2ml of 2% lidocaine and 1:80,000 epinephrine (lidocaine 20 mg/ml, epinephrine 12.5 mμ/ml)] at a rate of 1 mL/min.
15989640|NCT02966054|Behavioral|Digital Health Physical Activity Intervention Group|Print materials on exercise after cancer, Fitbit Flex for 12 weeks, and daily Text Messages for 12 weeks
15989641|NCT02966041|Drug|Ondansetron|Ondansetron/Zofran is an antiemetic drug used to prevent and treat nausea and vomiting.
15989642|NCT02966041|Drug|Saline|Normal saline is salt water and is acting as a placebo in this study. A placebo is an inactive substance that looks identical to the test drug, but it contains no therapeutic ingredient.
15989643|NCT02966028|Drug|SNF472|Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
15989644|NCT02966028|Drug|Placebo|Administered 3 times weekly by intravenous infusion through the dialysis machine in conjunction with the patient's dialysis sessions.
15989645|NCT02966015|Device|Coloplast test catheter|This is a newly developed catheter
15989646|NCT02966002|Drug|Aspirin|
15989647|NCT02965989|Procedure|Online training of a nursing technique|The professionals with participant in the experimental arm receive an online training of a technique of extraction of blood culture and other arm the professionals no receive any training. They work as usual.
15989648|NCT02965976|Biological|Botulinum Toxin Type A|Given IM
15989649|NCT02965976|Procedure|Esophagectomy|Undergo esophagectomy
15989650|NCT02965976|Other|Quality-of-Life Assessment|Ancillary studies
15989651|NCT02965963|Drug|Dopamine|
15989652|NCT02965963|Drug|Metoclopramide|
15989653|NCT02965963|Drug|Placebos|
15989654|NCT02965963|Other|Rest|
15989655|NCT02965963|Other|Exercise - 60%|60% of VO2max
15989656|NCT02965963|Other|Exercise - 85%|85% of VO2max
15989657|NCT02965950|Drug|Cyclophosphamide|I.v. infusion
15989658|NCT02965937|Other|Story-centred care intervention program|"Participants in the intervention group received the Story-Centred Care Intervention Program once a week for four weeks."
15989659|NCT02965937|Other|Health consultation control condition|The control group received a health consultation from researchers once a week for four weeks.. The health consultation will be tailored to the participants' needs. Based on a previous study12, the health consultation will include pain management, healthy nutrition, how to make best use of medical services and education and counselling for individual health-related concerns.
15989660|NCT02965924|Drug|Phenylephrine 2.5%|Instilling phenylephrine 2.5% eye drop
15989661|NCT02965911|Drug|Fenofibrate|Fenofibrate is a drug of the fibrate class. it reduces both low-density lipoprotein (LDL) and very low density lipoprotein (VLDL) levels, as well as increasing high-density lipoprotein (HDL) levels and reducing triglyceride levels.
15989662|NCT02965911|Drug|UDCA|Ursodeoxycholic acid，the abbreviation UDCA, is one of the secondary bile acids, which are metabolic byproducts of intestinal bacteria，it is the only FDA approved drug to treat PBC.
15989665|NCT02965885|Drug|TAS-116|TAS-116 is an oral heat shock protein 90 (HSP90) inhibitor investigated in 3 dosing regimens (QD, QOD, 5 days on 2 days off) in patients with advanced solid tumor and then at one dose schedule in advanced breast and lung cancer.
15989667|NCT02965859|Drug|Metacavir Enteric-coated Capsules 80mg|Metacavir Enteric-coated Capsules 80mg
15989668|NCT02965859|Drug|Metacavir Enteric-coated Capsules 160mg|Metacavir Enteric-coated Capsules 160mg
15989669|NCT02965859|Drug|Metacavir Enteric-coated Capsules 320mg|Metacavir Enteric-coated Capsules 320mg
15989670|NCT02965859|Drug|Metacavir Enteric-coated Capsules Placebo 240mg|Metacavir Enteric-coated Capsules Placebo 240mg
15989671|NCT02965859|Drug|Metacavir Enteric-coated Capsules Placebo 160mg|Metacavir Enteric-coated Capsules Placebo 160mg
15989672|NCT02965859|Drug|Metacavir Enteric-coated Capsules Placebo 320mg|Metacavir Enteric-coated Capsules Placebo 320mg
15989673|NCT02965859|Drug|Adefovir Dipivoxil Capsule10mg|Adefovir Dipivoxil Capsule10mg
15989674|NCT02965859|Drug|Adefovir Dipivoxil Capsule Placebo 10mg|Adefovir Dipivoxil Capsule Placebo 10mg
15989675|NCT02965846|Drug|AGN-195263|1 drop of AGN-195263 will be instilled in each eye twice daily.
15989676|NCT02965846|Drug|Vehicle|1 drop of AGN-195263 vehicle(placebo) will be instilled in each eye twice daily.
15989677|NCT02965833|Device|3% hydrogen peroxide solution with HydraGlyde® Moisture Matrix|For cleaning, disinfection and overnight storage of contact lenses
15989678|NCT02965833|Device|Habitual Multi-Purpose Contact Lens Solution|
15989679|NCT02965833|Device|Habitual Contact Lenses|Participant's habitual contact lens brand worn in a daily wear modality for 30 days.
15989680|NCT02965820|Device|Opti-Free® PureMoist® contact lens solution|
15989681|NCT02965820|Device|Habitual Multi-Purpose Contact Lens Solution|
15989682|NCT02965820|Device|Habitual Contact Lenses|Subject's habitual contact lens brand worn in a daily wear modality for 30 days.
15989683|NCT02965807|Device|Bronchial Thermoplasty|patients will be under Bronchial Thermoplasty approximately every three weeks.And totally having three surgerys will be considered as completed.
15989684|NCT02965794|Other|Care pathways for colorectal cancer|development of a care pathway for this patient group
15989685|NCT02965781|Drug|SADBE|Topical solution
15989686|NCT02965781|Other|Placebo|Topical solution
15989687|NCT02965768|Drug|Naltrexone HCl|4.5 mg Naltrexone HCl, p.o., nocte (standard-dose); 3.0 mg Naltrexone HCl, p.o., nocte (optional-dose);
15989688|NCT02965755|Other|Treatment recommendation|Depending on the results from the participant's archival tissue, a panel of Johns Hopkins investigators will meet to interpret the molecular and genetic profiling results in order to identify any actionable mutations to provide a personalized treatment recommendation for the patient.
15989689|NCT02965742|Device|Stratos|A machine made by DMS group.
15989690|NCT02965742|Device|"Hologic QDR 4500A"|A machine made by Hologic inc.
15989691|NCT02965742|Device|"Hologic HORIZON A"|A machine made by Hologic inc.
15989692|NCT02965729|Behavioral|Family-based weight management|"The Our Lifestyles, Our Lives family-based weight management intervention consisted of 10 weekly 90-minute group sessions focused on physical activity, nutrition, and behavioral modification. Parents and siblings were encouraged to join the participant in these sessions. Sessions were interactive and included cooking demonstrations, light to moderate intensity physical activity that engaged all family members, and behavioral counseling sessions in both mixed (parent and child) and parent-only format."
15989693|NCT02965729|Behavioral|Pedometer|In addition to participating in the family-based weight management intervention, participants were given a pedometer (Omron HJ-324U, Omron Healthcare, Lake Forest, IL) and instructions at session 1. Participants were asked to wear the pedometer every day for the entirety of the program and return at session 10.
15989694|NCT02965729|Behavioral|Individualized step goals|In addition to participating in the family-based weight management intervention, participants were given a step goal to increase their activity by 500 steps each week (above baseline calculated as average daily steps/day during week 1).
15989695|NCT02965716|Biological|Pembrolizumab|Given IV
15989696|NCT02965716|Biological|Talimogene Laherparepvec|Given IL
15989697|NCT02965703|Drug|Aspirin|Given PO
15989698|NCT02965703|Other|Laboratory Biomarker Analysis|Correlative studies
15989699|NCT02965703|Other|Placebo Administration|Given PO
15989700|NCT02965703|Other|Questionnaire Administration|Ancillary studies
15989701|NCT02965690|Procedure|NexGen CR|Total Knee Replacement
15989702|NCT02965690|Procedure|GMK Sphere|Total Knee Replacement
15989703|NCT02965677|Device|Paclitaxel Releasing Peripheral Balloon Dilatation Catheter|in this group the subject will be treated by Paclitaxel Eluting Balloon Dilatation Catheter
15989704|NCT02965677|Device|Peripheral Balloon Dilatation Catheter|in this group the subject will be treated by Paclitaxel Eluting Balloon Dilatation Catheter
15989705|NCT02965664|Drug|PresbiDrops (CSF-1)|PresbiDrops (CSF-1) is a topical ophthalmic drug.
15989706|NCT02965664|Drug|Placebo|Placebo drops contain the same ingredients as PresbiDrops except for the active ingredients
15989707|NCT02965651|Behavioral|ECA System|"The ECA system, named Gabby, included content pertaining to stress management, nutrition and physical activity as well as dialogue scripts and media such as meditations. The scripts included motivational interviewing dialogue: dialogue to simulate shared decision making interactions and additional longitudinal interaction using techniques such as goal setting, problem solving, tips, and homework. Gabby was available on a web browser through a username and secure password login."
15989708|NCT02965638|Other|Oxygen|The intervention arm (Oxygen Group) will receive oxygen via nasal cannula at a rate of 4L of FiO2 93-100% from an oxygen concentrator up to 24 hours daily
15989709|NCT02965638|Other|Administration of placebo gas|The placebo arm (Placebo Group) will receive air via nasal cannula up to 24 hours daily
15989710|NCT02965612|Device|Injex|administration of Specific Immunotherapy (ITS) with car pressure injector without a needle
15989711|NCT02965612|Procedure|SCIT|administration of Specific Immunotherapy (ITS) via traditional subcutaneous
15989712|NCT02965599|Drug|GSK3117391|GSK3117391 (Dose A) is a white, opaque, gelatin capsule.
15989713|NCT02965599|Drug|Placebo|Placebo is a white, opaque, gelatin capsule.
15989714|NCT02965586|Drug|intrathecal|intrathecal block will be performed in sitting position using 25 G spinal needle at either the L3-L4 or L4-L5 intervertebral spaces.
15989715|NCT02965573|Biological|ARGX-113|
15989716|NCT02965573|Drug|Placebo|
15989717|NCT02965560|Diagnostic Test|plasma suPAR, PGE2 measurement. Other biomarkers were just recorded from clinical laboratory.|
15989718|NCT02965547|Device|Remote ischemic conditioning equipment|The RIPC consisted of 4 cycles of extremities ischemia (5-minute blood-pressure cuff inflation to 200 mm Hg, followed by 5-minute cuff deflation). The tourniquets were applied to one side upper arm and other side thigh. This intervention was undertaken one time in total.
15989719|NCT02965547|Procedure|Intravenous blood collection|Nurses will collect intravenous blood 6ml twice(at baseline and 1h after RIPC).The blood samples will be stored for laboratory test.The blood samples only use for the trial.
15989720|NCT02965547|Procedure|dCA measurement|Serial measurements of dCA were performed at 7 time points, baseline, 1h, 3h, 6h, 9h, 12h, 24h after RIPC.The continuous ABP was measured non-invasively using a servo-controlled plethysmograph (Finometer Pro, the Netherlands) at the middle finger. Two 2 MHz transcranial Doppler probe was used to measure continuous cerebral blood flow velocity (CBFV) simultaneously in the bilateral middle cerebral arteries at a depth of 45-60 mm Endtidal CO2 was monitored using a capnograph (MultiDop X2, DWL, Sipplingen, Germany). The probes were placed over temporal windows and fixed with a customized head frame. CBFV and continuous arterial blood pressure were recorded simultaneously from each subject in the supine position for 10 minutes. All data were recorded for further assessment and analysis.
15989721|NCT02965534|Device|Spectacle/Glasses|
15989722|NCT02965521|Behavioral|Website and text messages|Participants receive a personalized diet report, access to a digital health dietary intervention, and text messages for 12 weeks.
15989723|NCT02965508|Other|Home-based Primary Care|Care in the programs is inter-professional and team-based. Each physician leads a team charged with the care of a panel of patients and directs the team's activities. New patients are assigned a Mount Sinai Visiting Doctors (MSVD) primary care physician or the Chelsea Village House Calls Program (CVHCP) who makes an initial visit within 2 weeks of the patient's enrollment in the program. The primary care physician completes a comprehensive medical history and physical exam during the initial visit including standardized assessments of physical functioning and cognition. The primary care physician then provides ongoing management of the patients' acute and chronic health problems, including palliative and home hospice care when needed, every 2 to 12 weeks as determined on a case-by-case basis.
15989724|NCT02965508|Other|Usual Care|Office based care
15989725|NCT02965495|Drug|YYD302 2ml|YYD302 2ml
15989726|NCT02965495|Drug|YYD302 3ml|YYD302 3ml
15989727|NCT02965495|Drug|Placebo 3ml|phosphate buffered saline 3ml
15989728|NCT02965482|Device|Wright Nebulizer|Roxon Medi-Tech, Montreal, QC, Canada
15989729|NCT02965482|Device|Aerogen Solo Nebulizer|Aerogen Ltd., Galway, Ireland
15989730|NCT02965469|Behavioral|Breathe2Relax|The app teaches diaphragmatic breathing and has audiovisual coaching
15989731|NCT02965456|Drug|IDP 121 Lotion|IDP-121 lotion will be applied as per the instructions provided by the investigational center staff.
15989732|NCT02965456|Drug|IDP-121 Vehicle Lotion|IDP-121 vehicle lotion will be applied as per the instructions provided by the investigational center staff.
15989733|NCT02965443|Drug|Dapagliflozin 10 mg + Saxagliptin 5 mg|24 weeks intervention with Dapagliflozin 10 mg + Saxagliptin 5 mg
15989734|NCT02965443|Drug|Placebo 1 10 mg + Placebo 2 5 mg|24 weeks intervention with Placebo 1 10 mg + Placebo 2 5 mg
15989735|NCT02965430|Device|AL-SENSE|A diagnostic pantyliner for detection of amniotic fluid leaks compared with standard clinical diagnosis
15989736|NCT02965417|Drug|Sym004|Sym004 is a 1:1 mixture of two monoclonal antibodies (mAbs) which bind to two non-overlapping epitopes of the Epidermal Growth Factor Receptor (EGFR).
15989737|NCT02965404|Biological|Investigational live attenuated varicella vaccine|The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
15989738|NCT02965404|Biological|control live attenuated varicella vaccine|The control vaccine was manufactured by Shanghai Institute of Biological Products Co., Ltd. (SIBP)
15989739|NCT02965404|Biological|diluent of lyophilized vaccine|The diluent of lyophilized vaccine was manufactured by Sinovac (Dalian) Vaccine Technology
15989740|NCT02965378|Drug|Docetaxel|Given IV
15989741|NCT02965378|Drug|FGFR Inhibitor AZD4547|Given PO
15989742|NCT02965378|Other|Laboratory Biomarker Analysis|Correlative studies
15989743|NCT02965352|Device|Door handle device|To evaluate the cylindrical grip movement, it was used a door handle, which evaluated all the strength at the arc of motion
15989744|NCT02965352|Device|Linear switch device|To evaluate the pulp-pulp pinch movement, it was used one linear switch, which evaluated all the strength at the motion displacement.
15989745|NCT02965352|Device|Door key device|To evaluate the pulp-side pinch movement, it was used a door key, which evaluated all the strength at the arc of motion
15989746|NCT02965326|Procedure|Nasal swab; rectal biopsy.|Nasal epithelial cells will be obtained by nasal swabs from patients of the three arms; intestinal epithelial cells will be obtained, by rectal biopsy, only from patients treated by CFTR modulators.
15989747|NCT02965313|Procedure|SSLS Procedure|Synthetic suture repair
15989748|NCT02965313|Procedure|BSSVF-M Procedure|Bilateral sacrospinous vaginal vault fixation with synthetic mesh arms
15989749|NCT02965287|Other|Serum metabolomics profiling|The serum samples will be used to get a metabolomic profile
15989750|NCT02965274|Drug|Torrent's Fluoxetine Tablets|
15989751|NCT02965274|Drug|Warner Chilcott LLC's Sarafem Tablet|
15989752|NCT02965261|Drug|Torrent's Fluoxetine Tablets|
15989753|NCT02965261|Drug|Warner Chilcott LLC Sarafem Tablets|
15989754|NCT02965248|Drug|Standard adjuvant systemic chemotherapy|"Patients undergo radical surgery with standard adjuvant systemic chemotherapy (mFOLFOX6/CapeOx/sLV5FU2/Cape).
~mFOLFOX6: oxaliplatin 85 mg/m2 IV d1 + leucovorin calcium 400 mg/m2 IV d1 + 5-FU 400 mg/m2 IV bolus d1 + 5-FU 2400 mg/m2 continuous IV over 46-48 hours d1-2. Repeat every two weeks for twelve cycles.
~CapeOx: oxaliplatin 130 mg/m2 IV d1 + capecitabine 1000mg/m2 po bid d1-14. Repeat every three weeks for eight cycles.
~sLV5FU2: leucovorin calcium 400 mg/m2 IV d1 + 5-FU 400 mg/m2 IV bolus d1 + 5-FU 2400 mg/m2 IV over 46-48 hours d1-2. Repeat every two weeks for twelve cycles.
~Cape: capecitabine 1000mg/m2 po bid d1-14. Repeat every three weeks for eight cycles."
15989755|NCT02965248|Procedure|Hyperthermic intraperitoneal chemotherapy (HIPEC) with raltitrexed|Raltitrexed (3 mg/m2) is added to the perfusate after attaining 42 degrees of inflow temperature and last for 60 minutes.
15989756|NCT02965248|Procedure|Hyperthermic intraperitoneal chemotherapy (HIPEC) with oxaliplatin|Before the beginning of HIPEC, 5-FU 400 mg/m2 and leucovorin calcium 20 mg/m2 will be administered intravenously to potentiate oxaliplatin activity. Oxaliplatin (130 mg/m2) is added to the perfusate after attaining 42 degrees inflow temperature with a total of 30 minutes perfusion time.
15989757|NCT02965222|Device|the time-lapse videography|The all oocytes will be placed in the Time-Lapes .The third day the top-grade embryo will be selected by time-lapse imaging (TLI) .
15989758|NCT02965209|Procedure|motorized spiral enteroscopy|Novel Motorized Spiral Enteroscopy (NMSE) represents a new technology which offers all of the advantageous options of spiral enteroscopy with a faster and less invasive approach. When the region of interest in the small bowel is reached by NMSE standard endoscopic techniques, e.g. argon plasma coagulation (APC), forceps biopsy or endoscopic mucosal resection (EMR) are performed for treatment and/or tissue acquisition.
15989759|NCT02965196|Drug|IV Dexamethasone Therapy|
15989760|NCT02965196|Other|IV Normal Saline (NaCl 0.9%)|
15989761|NCT02965183|Other|Temperature measurements|
15989762|NCT02965157|Biological|CART20|
15989763|NCT02965144|Other|no treatment|no treatment
15989764|NCT02965131|Procedure|Temporary portocaval shunt|The hepatic artery, bile duct, and portal vein are dissected and clamped. The retrohepatic vena cava is preserved with selective clamping of the hepatic veins during total hepatectomy. Then, temporary portocaval shunt is constructed by end-to-end anastomosis of the portal vein stump to the middle and left hepatic vein trunk or by end-to-side anastomosis of the stump to the infrahepatic vena cava depending on the remaining length of the vessels.
15989765|NCT02965118|Drug|PAC-14028 cream 1.0%|topical application
15989766|NCT02965118|Drug|PAC-14028 cream Vehicle|topical application
15989767|NCT02965105|Device|Coloplast Test Catheter|This is a newly developed intermittent catheter
15989768|NCT02965105|Device|Speedicath|This is a marketed Catheter which is used as comparator
15989769|NCT02965092|Genetic|Second generation CAR-T cells|
15989770|NCT02965079|Device|ECCO2R|The ECCO2R system was developed from the principle of ECMO systems by underscoring the importance of carbon dioxide elimination rather than direct improvement of oxygenation in some patients. The circuit of the ECCO2R system can be set up in venovenous (VV) or arteriovenous (AV). For VV setup, a low flow pump is used to maintain a low extracorporeal flow rate using only 20-30 % of cardiac output. The ECCO2R system does not provide complete pulmonary function as it can achieve only limited oxygenation but provides predominantly carbon dioxide removal. As neither VV nor AV circuit allows full cardiopulmonary bypass, the system provides respiratory function but no cardiac support
15989771|NCT02965066|Device|Coloplast Test Catheter|Newly developed intermittent catheter
15989772|NCT02965066|Device|Coloplast Speedicath|Marketed Coloplast Speedicath catheter
15989773|NCT02965053|Drug|EOS789|
15989774|NCT02965053|Drug|Placebo|
15989775|NCT02965053|Drug|Renvela|
15989776|NCT02965040|Drug|Roxadustat|Oral
15989777|NCT02965027|Drug|Prazosin|
15989778|NCT02965027|Drug|Placebos|
15989779|NCT02965014|Behavioral|Face-to-Face Young Women's CoOp (YWC)|Participants will be offered HIV counseling and testing (HCT) and a two-session face-to-face YWC intervention. The face-to-face sessions will include information addressing the intersection of substance use, sexual risk, and violence through skill building, role-play, and rehearsal.
15989780|NCT02965014|Behavioral|mHealth Young Women's CoOp (YWC)|Participants will be offered HIV counseling and testing (HCT) and training on the mHealth application, which will include all content addressed in the face-to-face YWC delivery format. Participants will also be offered a tablet to complete the two-session intervention.
15989781|NCT02965014|Behavioral|HIV Counseling and Testing|Participants will be offered standard HIV counseling and testing (HCT).
15989782|NCT02965001|Drug|68Ga-NOTA-AE105|The patients are refered to an uPAR-PET/CT scan before initiation of the routine radiotherapy and the prognostic efficacy is assessed by registration of recurrence rate and death at routine clinical follow-up.
15989783|NCT02964988|Drug|Injection of PET tracer 68Ga-NOTA-AE105|Following injection of 68Ga-NOTA-AE105 the patients will be subjected to whole body PET/CT
15989784|NCT02964988|Device|PET/CT|Whole body PET/CT
15989785|NCT02964975|Procedure|Percutaneous coronary intervention|Recanalisation of chronic total occlusion of coronary artery
15989786|NCT02964975|Drug|Optimal medical therapy|Medical threatment according to guidelines
15989787|NCT02964962|Device|29 mm LOTUS Edge™ Valve System|Transcatheter aortic valve replacement
15989788|NCT02964949|Drug|Edoxaban|Edoxaban will be provided in blister packs with active and placebo tablets maintaining the blind, i.e., one 60 mg active tablet and a 15 mg placebo or one 60 mg active tablet and a 15 mg active tablet. Transition doses of 30 mg + 15 mg edoxaban are provided in 14-tablet blister packs.
15989789|NCT02964936|Drug|roxadustat|Oral administration
15989790|NCT02964910|Biological|Recombinant Hepatitis E Vaccine (Escherichia Coli)|Participants would receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) intramuscularly at 0, 1, 6 month.
15989791|NCT02964897|Behavioral|Peer-support plus usual care from the Health Care for Reentry Veterans program|a peer mentor who is also a veteran will establish a relationship with each subject and provide instrumental and emotional support to the subject during the first 6 months of the subject's release from incarceration. This is in addition to the usual reentry support provided by the Health Care for Reentry Veterans program.
15989792|NCT02964897|Behavioral|Usual care from the Health Care for Reentry Veterans program|Health Care for Reentry Veterans program provides reentry planning while the veteran is incarcerated. An outreach worker visits the veteran in the incarceration facility to conduct a needs assessment and help create a reentry plan to cover issues such as where they will be housed, what health care appointments they will need in the first 30 days, whether they need legal assistance, etc.
15989793|NCT02964884|Drug|Lovastatin|Those in the Lovastatin group will receive 20mg of Lovastatin per day for the first two weeks and 40mg of Lovastatin per day starting at week 3 through week 11.
15989794|NCT02964884|Behavioral|reading tutoring intervention|After the initial 12 weeks of Lovastatin or placebo, children will return for one week of intensive, one-on-one tutoring intervention (either reading or sham; Visit 2)
15989795|NCT02964884|Drug|Placebo Oral Tablet|Those in the placebo group will receive a tablet daily
15989796|NCT02964884|Behavioral|"Other Academic sham tutoring"|No reading (sham) tutoring. Children will receive intensive tutoring on a subject other than reading.
15989797|NCT02964871|Device|Sofia Fluorescent Immunoassay Analyzer Influenza A+B|The Sofia Influenza A+B Fluorescent Immunoassay (FIA) uses advanced immunofluorescence-based lateral-flow technology to detect influenza A and influenza B viral nucleoprotein antigens.
15989798|NCT02964871|Other|Usual care|Our team will discuss our interest in monitoring influenza antiviral treatment and prophylaxis courses, antibiotic courses, clinician and emergency room visits, respiratory infection-related hospitalizations, all-cause hospitalizations, and deaths during the anticipated 4-month influenza season over 3 years.
15989799|NCT02964858|Radiation|Standard Arm|Radiation will be started within 3-4 weeks of completion of chemotherapy. Computed Tomography (CT)scan will be acquired for treatment planning, which will be done using External Beam Planning System. The target volumes will be defined by clinical examination, staging Positron Emission Tomography with CT (PET-CT) and response PET-CT. The staging PET-CT will be fused and co-registered with the planning CT scans for target volume delineation. For Involved Field Radiotherapy,Clinical target volume (CTV) will include the entire nodal region depending on the site involved. For Involved Site RT , CTV will include the involved nodal volume in the staging PET-CT. For extranodal sites, the CTV will include the involved extranodal region as per the staging PET-CT. The total dose will be prescribed to the Planning Target Volume based on dose uniformity guidelines. All patients will be treated with 3 Dimensional Conformal Radiotherapy or Intensity Modulated Radiotherapy where indicated.
15989800|NCT02964858|Radiation|Experimental Arm|Radiation will be started within 3-4 weeks of completion of chemotherapy. Computed Tomography (CT)scan will be acquired for treatment planning, which will be done using External Beam Planning System. The target volumes will be defined by clinical examination, staging Positron Emission Tomography with CT (PET-CT) and response PET-CT. The staging PET-CT will be fused and co-registered with the planning CT scans for target volume delineation. For Involved Field Radiotherapy,Clinical target volume (CTV) will include the entire nodal region depending on the site involved. For Involved Site RT,CTV will include the involved nodal volume in the staging PET-CT. For extranodal sites, the CTV will include the involved extranodal region as per the staging PET-CT. The total dose will be prescribed to the Planning Target Volume based on dose uniformity guidelines. All patients will be treated with 3 Dimensional Conformal Radiotherapy or Intensity Modulated Radiotherapy where indicated.
15989801|NCT02964845|Behavioral|WISH with CHW and referral to HFM|6 intervention counseling sessions with a peer CHW, as well as CHW facilitated linkage to primary care and HIV risk reduction.
15989802|NCT02964845|Other|Enhanced Treatment as Usual|Linkage to Primary care.
15989803|NCT02964832|Device|Grasp method|
15989804|NCT02964832|Device|Armband-in-hand method|
15989805|NCT02964832|Device|Armband-on-arm method|
15989806|NCT02964819|Other|exercise|
15989807|NCT02964819|Device|Interferential current therapy|
15989808|NCT02964819|Device|Therapeutic Ultrasound|
15989809|NCT02964806|Dietary Supplement|Ordinary Diet|
15989810|NCT02964806|Dietary Supplement|Modified Atkin's Diet|
15989811|NCT02964806|Dietary Supplement|Ketogenic Diet|
15989812|NCT02964793|Other|intervention group|"The intervention will include
~clinician training sessions, designed to raise awareness of the importance of monitoring for FGR and standardizing SFH measurements
~the use of SFH charts and EFW customised charts, built with the same software allowing all information to be recorded on an unique document
~the use of the EFW values mentioned on US report, to plot EFW on the customised chart
~and explicit recommendations about interpretation of longitudinal values of SFH and EFW measurements. If slopes through consecutive plots are not parallel to either of the predicted centile lines (90th, 50th, 10th) on the chart, and either of the centile lines are 'crossed', fetal biometry by ultrasound scan will be recommended."
15989813|NCT02964780|Procedure|Gastric bypass surgery|
15989814|NCT02964780|Behavioral|Conservative weight loss program|
15989815|NCT02964754|Device|CT scan for internal fixation|In the observation group, digital three-dimensional models will be established by CT scan for internal fixation.
15989816|NCT02964754|Procedure|conventional internal fixation|In the control group, patients will undergo conventional internal fixation.
15989817|NCT02964741|Device|Active Comparator|non-invasive brain stimulation (active protocol)
15989818|NCT02964741|Device|Sham Comparator|non-invasive brain stimulation (sham protocol)
15989819|NCT02964728|Drug|Botulinum Neurotoxin Type A|topical injection
15989820|NCT02964728|Other|Normal saline|topical injection
15989821|NCT02964715|Drug|Empagliflozin|25 mg daily for 6 months
15989822|NCT02964702|Device|Thrombectomy Device T-01|
15989823|NCT02964689|Drug|Binimetinib|Binimetinib will be administered in combination with pemetrexed and cisplatin (induction therapy), and with pemetrexed only (maintenance therapy), during the first 2 weeks of each cycle. Cycles will be repeated every 21 days.
15989824|NCT02964689|Drug|Pemetrexed|Pemetrexed 500 mg/m2 i.v. is applied on day 1 of each cycle, before cisplatin administration
15989825|NCT02964689|Drug|Cisplatin|Cisplatin 75 mg/m2 i.v. is applied on day 1 of each induction therapy cycle. The drug must be administered after pemetrexed infusion
15989826|NCT02964676|Procedure|ab interno trabeculectomy with Trabectome|123 PACG will be recruited to receive ab interno trabeculectomy with Trabectome and before this surgery, laser peripheral iridectomy will be performed firstly
15989827|NCT02964676|Procedure|trabeculectomy|123 PACG will be recruited to receive trabeculectomy to reduce IOP
15989828|NCT02964663|Device|esCCO|comparison of non-invasive monitoring esCCO vs VV on cardiac output measurements
15989829|NCT02964650|Device|Personalised rate-response settings|Rate response range fixed to limits suggested by force-frequency curve
15989830|NCT02964637|Other|Observational Study|
15989873|NCT02964286|Device|The Electric vibrating massager,SAMPO®|The technique used is The electric vibrating massager ''SAMPO®'', and patients are taught to apply the strong mode on the 15 specific points,5 min each, 3 times a day from Monday to Friday during chemotherapy course. The intervention follow the points are used to stimulate the hematopoietic function. According to their anatomical location: upper extremity are Hegu (LI4), Quchi (LI11); lower extremity are Xuehai (SP10); Sanyin-jiao (SP6), Taixi (K3), Zusanli (ST36), Taichong (LV3); and the top of head is Baihui (GV20). The used of all the points, except for Baihui (GV20), is bilateral.
15989831|NCT02964624|Other|Rehabilitation|Protocol will consist of three exercise/week for eight weeks. Each session will begin with the evaluation of pain by the volunteer. Starting with a warm up exercise in a cycle ergometer (CEE), for 5 minutes at free cadence, then the intensity will be set at 90% of the intensity obtained during the incremental test and maintained for 10 min. Afterward, four sets of three different resistance exercises (RE) will be performed at 70% of the load correspondent to 1RM test with one minute interval between sets and exercises. During CEE Borg scale will be taken every two minutes and during RE the OMNI scale taken at the end of every set to monitor the intensity. At the end of the session, cool down global stretching exercises for inferior members will be performed and the VAS evaluated.
15989832|NCT02964611|Behavioral|Observational Study|This is an observational study.
15989833|NCT02964598|Behavioral|Gamified intervention|A new mobile application for assisting in sleep regulation, duration 4-6 weeks
15989834|NCT02964598|Behavioral|Sleep coaching|A new personalized program, duration 4-6 weeks
15989835|NCT02964598|Device|Bright light|Morning bright light 10 000 lux maximum duration 4-6 weeks
15989836|NCT02964598|Other|Control|Minimal information on sleep timing and advancing the sleep rhythm
15989837|NCT02964598|Other|Psychoeducation|An extensive information platform in the internet created for this purpose
15989838|NCT02964585|Drug|Canagliflozin|100 mg
15989839|NCT02964585|Drug|Placebo|1 tablet daily for 16 weeks
15989840|NCT02964572|Drug|Glimepiride|In accordance with the standard treatment guidelines of diabetes, glimepiride as a drug of active comparator will be administered to improve blood sugar in patients with poorly controlled blood sugar.
15989841|NCT02964572|Drug|Empagliflozin|Empagliflozin as a drug of experimental will be administered to improve blood sugar in patients with poorly controlled blood sugar.
15989842|NCT02964559|Biological|Pembrolizumab|Given IV
15989844|NCT02964533|Other|thunder-fire moxibustion therapy|burn moxa stick and heat shenque acupoint
15989845|NCT02964533|Other|common moxa-stick moxibustion|burn moxa stick and heat shenque acupoint
15989846|NCT02964520|Behavioral|Neurofeedback training|uptraining alpha (8-11 Hz) and theta (5-7.5 Hz) frequency bands, inhibiting beta (15-30 Hz) and delta (2-4 Hz)
15989847|NCT02964520|Behavioral|Sham comparator: Sham neurofeedback training|in UNEVEN neurofeedback sessions (1,3,5,7,9): up-training lobeta (13-16 Hz) and hibeta (16-22 Hz), inhibiting alpha (8-11 Hz), theta (5-7.5 Hz) and hibeta (23-30 Hz) in EVEN neurofeedback sessions (2,4,6,8,10): down-training beta (13-16 Hz) and hibeta (16-22 Hz), inhibiting alpha (8-11 Hz), theta (5-7.5 Hz) and hibeta (23-30 Hz)
15989848|NCT02964507|Drug|GSK525762|GSK525762 will be administered.
15989849|NCT02964507|Drug|Placebo|Placebo will be administered.
15989850|NCT02964507|Drug|Fulvestrant|Fulvestrant will be administered.
15989851|NCT02964481|Genetic|Whole exome sequencing|DNA sequencing of protein coding sections of all genes
15989852|NCT02964468|Radiation|3DCRT treatment (sequential boost)|"Radiotherapy:
~3DCRT treatment (sequential boost) 25 fractions fraction 1,8Gy by administering a total dose of 45 Gy on tumor and lymph nodes and lymph node chains more pelvic margin determined according to protocol.
~3 fractions fraction 1,8Gy by sequentially administering an additional dose of tumor and lymph nodes 5,4Gy on more margin.
~Chemotherapy:
~According to routine clinical practice of the participating centers."
15989853|NCT02964468|Radiation|Dose Escalation Intensity Modulated Radiotherapy treatment|"Radiotherapy:
~IMRT treatment (concomitant boost technique) 25 fractions fraction 2,15Gy by administering a total dose of tumor and lymph nodes 53,75Gy on more margin. Simultaneously we will proceed to the irradiation of pelvic lymph node chains according to protocol, a division of 1,8Gy per session until a total dose of 45 Gy.
~Chemotherapy:
~According to routine clinical practice of the participating centers."
15989854|NCT02964455|Drug|Docetaxel|5 mg/m², 10 mg/m², or 15 mg/m² given intravenously twice weekly (depending on dose under investigation at time of registration) on days 1,4 (depending on allocation of treatment schedule) for 4-6 weeks during chest radiation
15989855|NCT02964455|Drug|Nedaplatin|5 mg/m², 10 mg/m², or 15 mg/m² given intravenously twice weekly (depending on dose under investigation at time of registration) on days 1,4 (depending on allocation of treatment schedule) for 4-6 weeks during chest radiation
15989856|NCT02964455|Radiation|chest radiation|continuous chest radiation at 64 Gy/32f
15989857|NCT02964442|Other|Capsinoids|12 mg of Gel capsules
15989858|NCT02964442|Other|Cold Stimulus|Cooling vest maintain at 14 degree Celsius
15989859|NCT02964429|Device|Diacap Pro High-Flux|During dialysis treatment ultrafiltration rate will be changed following a fixed schedule and resulting changes in Transmembrane Pressure (TMP) recorded to generate data for calculation of the in-vivo KUF.
15989860|NCT02964416|Drug|Injection Tramadol|
15989861|NCT02964416|Other|placebo|0.9% Normal saline in 10 ml syringe
15989862|NCT02964403|Drug|Cox-2|
15989863|NCT02964403|Drug|Indomethacin|
15989864|NCT02964390|Procedure|Balloon Pulmonary Angioplasty|
15989865|NCT02964377|Drug|(+)- Epicatechin|
15989866|NCT02964351|Biological|High PSA levels|
15989867|NCT02964338|Drug|Fremanezumab|Fremanezumab will be administered as per the dose and schedule specified in the respective arms.
15989868|NCT02964338|Drug|Placebo|Placebo matching to fremanezumab will be administered as per the schedule specified in the respective arms.
15989869|NCT02964325|Device|Mirasol platelets (MIR PLTs)|The final product to be transfused to the subject will be leukoreduced (LR), apheresis (Aph) single-donor platelets (PLTs) at the standard therapeutic dose of 1 unit of Aph PLTs containing ≥ 3.0 × 1.0E11 PLTs. MIR PLTs will be treated with the Mirasol pathogen reduction technology system.
15989870|NCT02964325|Device|Reference platelets (REF PLTs)|The final product to be transfused to the subject will be LR-Aph single-donor PLTs at the standard therapeutic dose of 1 unit of Aph PLTs containing ≥ 3.0 × 1.0E11 PLTs.
15989871|NCT02964312|Device|Nasal Implant|Latera implant placed as a standalone procedure or in conjunction with a turbinate reduction procedure in an office setting under local anesthesia.
15989872|NCT02964299|Device|Mandibular advancement bite block|Mandibular advancement bite block that provides mandibular advancement by 3 mm, 6 mm, or 9 mm from neutral position
15989874|NCT02964273|Drug|Phase A Tolvaptan|Tolvaptan 7.5, 15, and 30 mg spray-dried, immediate release tablets Frequency: Twice daily.
15989875|NCT02964273|Drug|Placebo Phase A|Frequency: Twice daily.
15989876|NCT02964273|Drug|Phase B Tolvaptan|Tolvaptan 7.5, 15, and 30 mg spray-dried, immediate release tablets Frequency: Twice daily.
15989877|NCT02964260|Drug|Chemotherapy drug|Doxorubicin/Platinum agents
15989878|NCT02964260|Drug|Embolic agents|Lipiodol/Gelatin sponge/PVA/Blank microspheres
15989879|NCT02964260|Procedure|Simultaneously|1-3 days
15989880|NCT02964260|Procedure|Sequentially|1 month
15989881|NCT02964260|Device|Ablation|Radiofrequency ablation/Microwave ablation
15989882|NCT02964247|Drug|liraglutide|Liraglutide given s.c. once daily, gradually titrated to 1.8 mg/day as an add-on to the subject's stable pre-trial SGLT2 inhibitor ± metformin for 26 weeks
15989883|NCT02964247|Drug|placebo|Liraglutide placebo given s.c. once daily, gradually titrated to 1.8 mg/day as an add-on to the subject's stable pre-trial SGLT2 inhibitor ± metformin for 26 weeks
15989884|NCT02964234|Behavioral|Empowerment|Three group sessions (breast cancer education; communication; volunteerism) 1.5 hours 3 times across 3 weeks
15989885|NCT02964234|Behavioral|Education|Three group sessions (breast cancer education; diet; physical activity) 1.5 hours 3 times across 3 weeks
15989886|NCT02964221|Other|Cognitive Testing|Computerized CogState Brief Battery (CBB), Cognigram, assesses changes in four cognitive domains including psychomotor function, attention, learning and memory, and working memory. The CBB is a computerized test based on card games that can be administered online. .
15989887|NCT02964208|Device|AMPLATZER™ LAA Occluder|The AMPLATZER™ LAA Occluder is intended to prevent thrombus embolization from the left atrial appendage (LAA) in patients who have nonvalvular Atrial Fibrillation (AF). It may be considered for use in patients who have a high risk of stroke and bleeding and are deemed by their physician to have an appropriate rationale to seek a non-pharmacologic alternative to long term anticoagulants.
15989888|NCT02964195|Drug|Rifaximin|ALFA WASSERMANN S.p.A.
15989889|NCT02964182|Drug|Cigarette|Smoke usual brand of cigarettes
15989890|NCT02964182|Other|Electronic Cigarette|Smoke ECIG-Hi
15989891|NCT02964182|Other|Electronic Cigarette|Smoke ECIG-Lo
15989892|NCT02964182|Other|Questionnaire Administration|Ancillary studies
15989893|NCT02964182|Other|Survey Administration|Ancillary studies
15989894|NCT02964182|Drug|Very Low Nicotine Content Cigarette|Smoke very low nicotine content cigarette
15989895|NCT02964169|Behavioral|Family Planning Support|
15989896|NCT02964156|Other|Supersole|A 4-mm thin, individually customized insole of a malleable plastic material (CI-Core®) with synthetic textile material on the upper side.
15989897|NCT02964156|Other|No intervention|No intervention
15989898|NCT02964143|Device|Cellular Matrix / A-CP HA|Treatment with 2 injections of Cellular Matrix / A-CP HA Kit, administered 2 months apart; Cellular Matrix / A-CP HA Kit is designed for the safe, rapid and extemporaneous preparation of a cellular matrix of autologous PRP combined with HA. The Cellular Matrix / A-CP HA Kit is a single-use medical device including hematology tubes (A-CP HA tube), designed for blood collection and PRP/HA preparation after 5 min centrifugation. This tube contains a non-crosslinked hyaluronic acid (MW 1550 kDa) solution, a gel acting as a cell separator, and a sodium citrate acting as an anticoagulant. During centrifugation, the separator gel moves to form a barrier that separates red blood cells from other blood components. The HA, which migrates to the top of the gradient during centrifugation, can be mixed with PRP in order to give rise to a ready-to-use PRP/HA preparation.
15989899|NCT02964143|Device|Ostenil® Plus|Treatment with 2 injections of Ostenil® Plus, administered one week apart; Ostenil® Plus is a solution of sodium hyaluronate obtained by fermentation, containing 0.5% mannitol, a free radical scavenger, which helps to stabilize the chains of sodium hyaluronate. The product is intended to be used for pain and restricted mobility in degenerative and traumatic changes of the knee joint.
15989900|NCT02964143|Device|RegenKit-BCT-1|Treatment with 2 injections of RegenKit-BCT-1, administered 1 month apart; RegenKit-BCT-1 is designed for the safe, rapid and extemporaneous preparation of autologous platelet-rich plasma. RegenKit-BCT-1 is a single-use medical device including an hematology tube (Regen BCT tube), designed for blood collection and PRP preparation after 5 min centrifugation, and all necessary material for venipuncture and PRP injection. The Regen BCT tube contains a gel acting as a cell separator and a sodium citrate acting as an anticoagulant. During centrifugation, the separator gel moves to form a barrier that separates red blood cells from other blood components.
15989901|NCT02964130|Other|No name|
15989902|NCT02964104|Drug|Insulin icodec|Administered once weekly subcutaneously (s.c., under the skin) for 35 days
15989903|NCT02964104|Drug|placebo|Administered once daily subcutaneously for 35 days
15989904|NCT02964104|Drug|insulin degludec|Administered once daily subcutaneously for 35 days
15989905|NCT02964104|Drug|placebo|Administered once weekly subcutaneously for 35 days
15989906|NCT02964091|Drug|sofosbuvir/ledipasvir|
15989907|NCT02964078|Drug|Pembrolizumab|Pembrolizumab: 200 mg every 3 weeks, 12 doses planned. This is considered the investigational part of the combination. The infusion time is 1 hour.
15989908|NCT02964078|Drug|Interleukin-2|Interleukin-2: 8 admissions to hospital, each with 5 doses planned. This is considered the standard part of the combination. The standard interleukin-2 dose is 600,000 international units per kilogram per dose, with a maximum of 66,000,000 (for patients over 110 kg, which is 242 pounds). The dose is usually set at the start of the treatment and not adjusted. The infusion time is 15 minutes.
15989909|NCT02964065|Biological|Live-Attenuated influenza Vaccine(LAIV)|
15989910|NCT02964065|Biological|Placebo|
15989911|NCT02964052|Other|Brain CT imaging|Investigators will analyzed the CT image that was performed in patients with hyperacute stroke. The CT protocol includes CT thrombus, collateral, core images. Investigators also obtain detailed history and laboratory and imaging result for comorbidity. The comorbidity index protocol is based on the Charlson comorbidity index.
15989912|NCT02964039|Behavioral|Error reduction|During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs toward mechanically-appropriate mediolateral locations, having the effect of reducing the errors in foot placement that are often present among individuals who have experienced a stroke.
15989913|NCT02964039|Behavioral|Error augmentation|During training sessions, a custom-built force-field will exert forces on the legs while participants walk. These forces will push the legs away from mechanically-appropriate mediolateral locations, having the effect of amplifying the errors in foot placement that are often present among individuals who have experienced a stroke.
15989914|NCT02964039|Behavioral|Activity matched control|During training sessions, participants will interface with a custom-built force-field while they walk. The force-field will essentially get out of the way, producing minimal forces on the legs, and having no direct effect on the errors in foot placement that are often present among individuals who have experienced a stroke.
15989915|NCT02964026|Device|pulmonary artery catheter|PAC must be placed between the day of admission and the day following a qualifying cardiac surgery
15989916|NCT02964013|Biological|vibostolimab|Administered as an intravenous (IV) infusion on Day 1 of 21-day infusion Cycles 1-35
15989917|NCT02964013|Biological|pembrolizumab|Administered as an IV infusion on Day 1 of 21-day infusion Cycles 1-35
15989918|NCT02964013|Drug|pemetrexed|Administered as an IV infusion on Day 1 of 21-day infusion Cycles 1-35
15989919|NCT02964013|Drug|carboplatin|Administered as an IV infusion on Day 1 of 21-day infusion Cycles 1-4
15989920|NCT02964013|Biological|pembrolizumab/vibostolimab coformulation|Administered as an IV infusion on Day 1 of 21-day infusion Cycles 1-35
15989921|NCT02964013|Drug|cisplatin|Administered as an IV infusion on Day 1 of 21-day infusion Cycles 1-4
15989922|NCT02964013|Drug|etoposide|Administered as an IV infusion on Days 1-3 of 21-day infusion Cycles 1-4
15989923|NCT02964000|Device|Low level 1 Watt|The Phoenix Thera-Lase System will be on 1 watt
15989924|NCT02964000|Device|Phoenix Thera-Lase System 42|The Phoenix Thera-Lase System will be on 42 watts
15989925|NCT02964000|Device|Phoenix Thera-Lase System 74|The Phoenix Thera-Lase System will be on 74 watts
15989926|NCT02963987|Other|Food and Beverage Portion Size|Variations of Food and Beverage Portion Size (100% Baseline portions and increased 50% for 150% portions)
15989927|NCT02963974|Device|Cochlear implant|Implantation
15989928|NCT02963961|Behavioral|Preoperative Cognitive Training Battery|Patients will engage in a daily preoperative cognitive training battery (BrainHQ, Posit Science) that aims to improve attention, memory, and visuospatial processing.
15989929|NCT02963948|Behavioral|Meetings with implementation leader(s)|The perceived appropriateness of the intervention to medical staff will affect an intervention's initial adoption as well as sustainability. We will assess this through focus groups with staff, conducted approximately 1-2 months after implementation of the screening and CDS tools.
15989930|NCT02963948|Behavioral|the SAAS survey|Medical staff will be surveyed using the Substance Abuse Attitude Survey (SAAS) to gather information about attitudes from medical staff who do not participate in the focus groups, or may be uncomfortable sharing negative attitudes in a group of their peers. The SAAS is a validated multidimensional instrument that evaluates physician attitudes toward substance-using patients. It includes specific measures of attitudes toward permissiveness, treatment intervention, stereotypes, treatment optimism, and moralism, and has been used in prior studies of primary care physicians. Collecting information on staff attitudes toward substance users and substance use interventions will be helpful to inform about any sources for low adoption of the tools, and any needs for additional provider education and training.
15989931|NCT02963948|Behavioral|Patient surveys|Patient surveys regarding attitudes toward substance use screening and interventions in the primary care clinic will be distributed to patients presenting for care, regardless of whether they completed screening, at regular time periods throughout this study phase. The survey will be conducted for 1 week at the following approximate intervals following successful implementation: 1 month, 4 months, 7 months, and 10 months
15989932|NCT02963935|Drug|liraglutide|Administered subcutaneously (s.c., under the skin) once daily for 56 weeks. Dose gradually increased to 3.0 mg
15989933|NCT02963935|Drug|placebo|Administered subcutaneously (s.c., under the skin) once daily for 56 weeks. Dose gradually increased to 3.0 mg
15989934|NCT02963935|Behavioral|CMS Intensive Behavior Therapy|Intensive Behaviour Therapy for obesity
15989935|NCT02963922|Drug|Liraglutide 3.0 mg|Injected subcutaneously (s.c., under the skin) once daily
15989936|NCT02963922|Drug|Placebo|Injected subcutaneously (s.c., under the skin) once daily
15989937|NCT02963909|Biological|IXIARO|An inactivated vaccine indicated for active immunization for the prevention of disease caused by Japanese encephalitis virus (JEV).
15989938|NCT02963909|Other|Placebo|0.9% Sodium Chloride 5 mcg
15989939|NCT02963909|Biological|YF Vax 17D Strain|A stabilised Yellow Fever Vaccine (Live) that is an injectable suspension of the attenuated 17D strain of yellow fever virus. The vaccine is injected by the subcutaneous route.
15989940|NCT02963909|Biological|Zika Virus Purified Inactivated Vaccine (ZPIV)|Zika Virus Purified Inactivated Vaccine with aluminum hydroxide adjuvant.
15989941|NCT02963896|Drug|gentamicin|intratympanic application of gentamicin 2m/80mg - 3x application -0,5 ml
15989942|NCT02963883|Other|SVO2 group / control group|
15989943|NCT02963870|Other|Security Plan|This study compared two groups of adolescents aged 12-17 hospitalized for TS and randomized to a group treated with the Security Plan plus the usual treatment and a group receiving standard treatment only.
15989944|NCT02963844|Other|Inspiratory Muscle Training|
15989945|NCT02963844|Other|Inspiratory Muscle Training Sham|
15989946|NCT02963831|Biological|ONCOS-102|ONCOS-102 will be administered intraperitoneally infusion at weekly intervals for 6 weeks.
15989947|NCT02963831|Drug|Durvalumab|Durvalumab will be administered by IV infusion once every four weeks for a total of 12 four-week cycles.
15989948|NCT02963818|Other|Smartphone breathalyzer device/app use|Participants randomized to this condition will be able to blow into the smartphone breathalyzer after consuming each alcoholic drink, which produces an accurate breath alcohol reading on the app. These breath alcohol readings may inform participants' subsequent decisions regarding drinking.
15989949|NCT02963818|Other|BAC estimator app use|Participants randomized to this condition will be able to make an entry into the BAC estimator app after consuming each alcoholic drink, which produces an estimated blood alcohol concentration based on the individual's sex, weight, number of alcoholic drinks and time spent drinking alcohol. These estimated blood alcohol concentrations may inform participants' subsequent decisions regarding drinking.
15989950|NCT02963818|Other|Text messaging procedure|Participants randomized to this condition will be instructed to send a text to a smartphone they will use for the study after each alcoholic drink. A consideration of the number of texts sent may inform participants' subsequent decisions regarding drinking.
15989951|NCT02963805|Behavioral|High intensity physical activity (HIPA)|This arm consisted of a twice-weekly after-school club at the intervention school for 26 weeks during school term time, delivered by qualified coaches. Each 60 minute session engaged participants in high-intensity vigorous activity using a combination of playground-style games and circuit training activities that aimed to keep children moving and maintain a mean heart rate above 70% of age-predicted maximum heart rate (~145 beats/min) for the session duration. Intensity was verified by heart rate monitoring. Coaches delivered and monitored sessions and increased the intensity over time to allow for the children to progress. The mean heart rate for HIPA sessions was 150 beats/min, with children spending 52 min at this intensity during the session.
15989952|NCT02963805|Behavioral|Fundamental movement skill (FMS)|This arm consisted of a twice-weekly after-school club at the intervention school for 26 weeks during school term time, delivered by qualified coaches. Each 60 minute session focused on improving two skills from the vertical jump, hop, sprint run, dodge, kick, catch, overarm throw, and strike. All skills were taught in equal quantities. Each session was designed to maximise participation and enjoyment, and consisted of various games, drills, self-learning activities, and offered numerous opportunities for practice. Skill components were taught to the children using simple learning cues, and skill related questions were used to develop purposeful feedback. The mean heart rate for FMS sessions was recorded at 141 beats/min, with children spending 55 min at this intensity during the session.
15989953|NCT02963805|Behavioral|Physical activity signposting (PASS)|A researcher visited participants once per week in 6 weekly blocks to set an activity mission to complete outside school with family and friends. Twenty missions were set over 4 x 6 week blocks, each separated by a 6 week break. Each mission suggests a task as a prompt to participate in physical activity and decrease sedentariness during the week. Children received a sticker on a wall chart for returning the mission; children were rewarded with prizes if all missions were returned in each block. If all missions were returned in a block, a reward was given. 58% of children returned all twenty missions. In addition to the missions, pedometers were issued as a promotional tool for the duration of the project for self-monitoring of activity.
15989954|NCT02963792|Other|Preventing Professionals burnout|
15989955|NCT02963779|Drug|LY2775240|Administered orally
15989956|NCT02963779|Drug|Placebo|Administered orally
15989957|NCT02963779|Drug|Apremilast|Administered orally
15989958|NCT02963766|Drug|Dulaglutide|Administered SC
15989959|NCT02963766|Drug|Placebo|Administered SC
15989960|NCT02963740|Behavioral|Supervised Exercise|Participants will take part in supervised exercise activities two times per week at a YMCA. Length of the activity will be increased during participation in study. Participants will start at 40 minutes per week and work their way up to 120 minutes per week.
15989961|NCT02963740|Behavioral|Home-based Exercise|Aerobic exercise activities to be completed at home. Participants will be asked to start out doing 60 minutes at home and work up to 180 minutes of purposeful aerobic home exercise per week.
15989962|NCT02963740|Behavioral|Group Phone Calls|Once weekly phone calls that are group-based. The calls will discuss lifestyle changes specific to participants and cover the effects of diet, physical activity, and weight on breast cancer risk, as well as body image and emotional eating.
15989963|NCT02963740|Behavioral|Diet|Participants will consume a nutritionally balanced, reduced calorie diet as recommended by the Academy of Nutrition and Dietetics.
15989964|NCT02963727|Biological|Wharton Jelly derived mesenchymal stem cell|Intra-articular Wharton Jelly derived mesenchymal stem cell injection.
15989965|NCT02963714|Biological|60 µg dose hepatitis B vaccine|three-dose, 60 µg per dose
15989966|NCT02963714|Biological|20 µg dose hepatitis B vaccine|three-dose, 20 µg per dose
15989967|NCT02963701|Drug|Ibuprofen|Fixed dose combination
15989968|NCT02963701|Drug|Pseudoephedrine-HCl|Fixed dose combination
15989969|NCT02963688|Genetic|Ion AmpliSeq BRCA 1/2 Panel (Life Technologies, Carlsbad, CA, USA) ,Ion PGM platform|BRCA1,2 Germline /Somatic mutation test
15989970|NCT02963662|Procedure|laparoscopic Roux-en-Y gastric bypass|Laparoscopic Roux-en-Y gastric bypass was one of the interventions pre-specified to be administered to participants. The patients undergo Roux-en-Y gastric bypass (RYGB group) following a comprehensive evaluation for the surgical indication
15989971|NCT02963662|Procedure|laparoscopic sleeve gastrectomy|Laparoscopic sleeve gastrectomy was the other intervention pre-specified to be administered to participants. The patients undergo sleeve gastrectomy (SG group) following a comprehensive evaluation for the surgical indication
15989972|NCT02963649|Device|DCB|Drug Coated Balloon
15989973|NCT02963649|Device|PTA|Percutaneous Transluminal Angioplasty
15989974|NCT02963636|Other|Pharmacist clinical intervention|Pharmacists will make a clinical intervention with patients. They will review patient drug therapy already prescribed in their usual care. This includes a medication reconciliation, an assessment of drug related problems, an assessment of the regimen complexity and adherence to treatment. A care plan will be elaborated. Moreover, immediate and future interventions with the patient or other health professionals will be implemented and monitored. There will be no drug or devices tested, it is a human clinical intervention by a pharmacist.
15989975|NCT02963610|Drug|Lenalidomide|Lenalidomide is a thalidomide analogue with immunomodulatory, anti-angiogenic, and antineoplastic effects. It is administered as a pill taken orally. It has completed phase III study evaluation and has FDA indications for use in certain patients with multiple myeloma, myelodysplastic syndrome, and mantle cell lymphoma.
15989976|NCT02963610|Drug|Pembrolizumab|Pembrolizumab is a humanized IgG4 monoclonal antibody which targets the PD-1 receptor, thus inhibiting the interaction between PD-1 and its ligands, PD-L1 and PD-L2 respectively. It is administered as an IV infusion. This drug has several studies in patients with solid tumors and currently has an FDA indication for use in patients with melanoma and non-small cell lung cancer.
15990009|NCT02963363|Other|Home-based Adapted Physical Activity|"Home-based adapted physical activity to attend progressively 150 minutes of physical activity per week at the end of neoadjuvant chemotherapy.
~5 times 30 minutes of walking + 3 times 30 minutes of muscle strengthening exercises per week during 18 weeks"
15990010|NCT02963350|Drug|BMN190, recombinant human tripeptidyl peptidase-1 (rhTPP1)|
15989977|NCT02963597|Device|AirSense™ 10 AutoSet|The AirSense 10 AutoSet is a device that provide non-invasive ventilatory support to treat patients with sleep disordered breathing. The device is intended for home and hospital use. The treatment pressure required by the patient may vary due to changes in sleep state, body position and airway resistance. In AutoSet mode, the device provides only that amount of pressure required to maintain upper airway patency. The AirSense 10 AutoSet provides a minimum and maximum pressure within the range of 4-20 cm of water.
15989978|NCT02963597|Other|Standard Medical Therapy|Standard medical therapy according to current guidelines.
15989979|NCT02963584|Other|decision aid|The related information about CTO and PCI procedures will be told to the patients thoroughly.
15989980|NCT02963571|Procedure|posterior percutaneous pedicle screw internal fixation|The patients underwent minimally invasive posterior percutaneous pedicle screw fixation in acute thoracolumbar vertebral fractures with simple anterior spinal column injury.
15989981|NCT02963558|Device|cycle ergometry|The cycler will provide 3 different possible modes of cycling-passive, active-assisted, and active. The subject will start with passive cycling and may progress to active-assisted and active cycling.
15989982|NCT02963545|Other|Usual care patients in neurology department|patients characteristics, history, clinical signs chronology and usual medical care by the emergency units, cerebral infarction area
15989983|NCT02963545|Biological|blood and urines sampling|Collection samples for biochemical determinations of serotonin pathway and kynurenine pathway parameters determinations
15989984|NCT02963545|Procedure|Psychiatric evaluation|depression scale, impulsivity scale, hostility scale , tobacco consumption questioning
15989985|NCT02963532|Other|We are observing criteria present at extubation|We will not be performing any intervention. We will only be observing what clinical data is present at the time of extubation and how predictive are different pieces of clinical data.
15989986|NCT02963519|Device|VistaCare®|
15989987|NCT02963519|Device|Dressings|
15989988|NCT02963506|Other|Placebo|
15989989|NCT02963506|Drug|Bimekizumab|Bimekizumab in different dosages.
15989990|NCT02963493|Drug|Melphalan flufenamide (Melflufen)|
15989991|NCT02963493|Drug|Dexamethasone|
15989992|NCT02963480|Procedure|Cardiac Surgery|
15989993|NCT02963467|Procedure|cigarette|smoking 4 conventional cigarettes
15989994|NCT02963467|Procedure|"dummy cigarette"|"smoking a dummy cigarette"
15989995|NCT02963454|Device|Microdialysis Probe (Muscle microdialysis)|"Interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were determined at baseline and then every six hours for the following 72 hours after randomization.
~During the study period, conventional treatment was continued as per usual practice. Fluid challenges were performed, and repeated as necessary, to maintain central venous pressure (CVP) ≥8 and pulmonary arterial occlusion pressure (PAOP) ≥12 mmHg. Norepinephrine was titrated to maintain mean arterial pressure (MAP) ≥65 mmHg. Packed red blood cells were transfused when Hemoglobin (Hb) concentrations decreased below 7 g/dL, or if the patient exhibited clinical signs of inadequate systemic oxygen supply."
15989996|NCT02963454|Drug|Dobutamine|Dobutamine (5 μg/kg/min) will be used as indicated
15989997|NCT02963454|Drug|Levosimendan|Levosimendan (0.2 μg/kg/min) will be used as indicated
15989998|NCT02963428|Behavioral|Enhanced Care|"In addition to standard of care, the study participants will also receive:
~i. An initial consult with a licensed, Registered Dietician Nutritionist (RDN); ii. Regular tele-health check-ups (10-20 mins/check-up) with the RDN until delivery; iii. Exposure to personal GWG chart; iv. Letter from physician stating the recommendations for GWG over the course of the pregnancy."
15989999|NCT02963415|Behavioral|Exergame|Participants will take part in the exergame, 3 times a week for a month. The session will start for 30-35 minutes of cycling on recumbent stationary cycles in session 1 and progress to moderate intensity for 50 minutes a session. Participants will do warm-up and cool-down activities before and after cycling. While cycling, participants will be playing virtual reality based games. An exercise interventionist will supervise the sessions and monitor participant's conditions and responses to ensure safety.
15990000|NCT02963402|Drug|Tocilizumab|
15990001|NCT02963402|Drug|Adalimumab|
15990002|NCT02963389|Drug|Tripegfilgrastim|
15990003|NCT02963376|Drug|0.05 mL/kg DDFPe|Prior to injection, DDFPe will be prepared by pharmacy staff. DDFPe will be administered based on weight. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. DDFPe dosage volume in cc for 0.05 mL/kg based on patient body weight in kilograms (kg).
15990004|NCT02963376|Drug|0.05 mL/kg Placebo|Prior to injection, the placebo will be prepared by pharmacy staff. The placebo will be administered based on weight at designated doses Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. The placebo dosage volume in cc for 0.05 mL/kg is based on patient body weight in kilograms (kg).
15990005|NCT02963376|Drug|0.10 mL/kg DDFPe|Prior to injection, DDFPe will be prepared by pharmacy staff. DDFPe will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. DDFPe dosage volume in cc for 0.10 mL/kg based on patient body weight in kilograms (kg).
15990006|NCT02963376|Drug|0.10 mL/kg Placebo|Prior to injection, the placebo will be prepared by pharmacy staff. The placebo will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. The placebo dosage volume in cc for 0.10 mL/kg is based on patient body weight in kilograms (kg).
15990007|NCT02963376|Drug|0.17 mL/kg DDFPe|Prior to injection, DDFPe will be prepared by pharmacy staff. DDFPe will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. DDFPe dosage volume in cc for 0.17 mL/kg based on patient body weight in kilograms (kg).
15990008|NCT02963376|Drug|0.17 mL/kg Placebo|Prior to injection, the placebo will be prepared by pharmacy staff. The placebo will be administered based on weight at designated doses. Each dose will be prepared on the day of administration and infused directly into the patient using a slow i.v push. The i.v. push shall be 5-10 minutes in duration. The placebo dosage volume in cc for 0.17 mL/kg is based on patient body weight in kilograms (kg).
15990011|NCT02963337|Drug|remifentanil|Remifentanil PCA will be used to deliver intravenous drug boluses from 20 to 40 micrograms per 2 min lockout interval.
15990012|NCT02963337|Drug|combined spinal-epidural analgesia|Patient controlled epidural analgesia will be used to deliver epidural boluses of 6-10 ml of 0,1% bupivacaine with 2 micrograms of fentanyl per ml per 15 min lockout interval.
15990013|NCT02963324|Drug|Ivermectin|
15990014|NCT02963311|Drug|ALN-PCSSC|ALN-PCSSC is a small interfering ribonucleic acid (siRNA) that inhibits PCSK9 synthesis and is given as SC injections.
15990015|NCT02963311|Drug|Standard of Care|Included maximally-tolerated statin therapy and/or other low density lipoprotein-cholesterol (LDL-C)-lowering therapies.
15990016|NCT02963298|Procedure|Continuous renal replacement therapy|
15990017|NCT02963285|Other|Nasopharyngeal temperature probe|Nasopharyngeal temperatures will initially be recorded 30 minutes after induction of anesthesia. Nasopharyngeal probes will then be withdrawn at the designated increment for each age group and will be equilibrated for 3 minutes before the temperature is recorded. Thereafter, the nasopharyngeal withdrawal sequence will be repeated.
15990020|NCT02963259|Device|SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system|Implanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system
15990021|NCT02963246|Behavioral|Mindfulness|"Mindfulness-based therapy has been used effectively to treat a variety of physical and psychological disorders, including depression, anxiety, and chronic pain. Recently, several lines of research have explored the potential for mindfulness-therapy in treating somatization disorders, including fibromyalgia, chronic fatigue syndrome, and irritable bowel syndrome. Mindfulness-based therapies (MBT) are a clinical application involving the key element of nonjudgmental acceptance of physical pain or psychological distress, thereby reducing the tendency to ruminate over and catastrophise these experiences.
~In the present study, we propose a mindfulness intervention of 12 months, with sessions either personalized or online."
15990022|NCT02963233|Procedure|Closed reduction and percutaneous pinning and immobilization|
15990023|NCT02963233|Procedure|Non-operative reduction and immobilization|
15990024|NCT02963220|Behavioral|CBT-AR|20-30 sessions of cognitive behavioral therapy for avoidant/restrictive food intake disorder (CBT-AR), held once per week in an outpatient setting
15990025|NCT02963207|Other|Modified Sano's classification|Set of characteristics described by Singh et al. 2013 to evaluate colorectal lesions.
15990026|NCT02963207|Other|NICE classification|Set of characteristics described by Hewett et al. 2012 to evaluate colorectal lesions.
15990027|NCT02963194|Drug|Oxytocin|
15990028|NCT02963194|Drug|Placebo|
15990029|NCT02963181|Drug|Yohimbine|Oral Yohimbine will be used to identify the integrity of post-ganglionic sympathetic nerves in patients with NOH
15990030|NCT02963181|Drug|Melatonin|"Monitor the effects of melatonin on supine hypertension in NOH patients with intact and denervated post-ganglionic nerves.
~Identify the mechanistic pathway of melatonin in blood pressure regulation"
15990031|NCT02963168|Drug|Oradoxel|oral docetaxel will be supplied in capsules and oral HM30181A-UK tablets
15990032|NCT02963155|Other|Blood samples|
15990033|NCT02963129|Drug|Mupirocin|Mupirocin ointment in the nose for 5 days
15990034|NCT02963129|Other|Placebo|Placebo ointment in the nose for 5 days
15990035|NCT02963116|Drug|AZD5718 IR tablet|
15990036|NCT02963116|Drug|AZD5718 oral suspension|
15990037|NCT02963116|Drug|Rosuvastatin tablet|
15990038|NCT02963103|Drug|Tacrolimus|Oral
15990039|NCT02963090|Drug|Topotecan|"Topotecan at 1.25mg/m2 on days 1 to 5 every 21-days until progression of disease or unacceptable toxicities.
~Patients with progression of disease by RECIST 1.1 will be allowed cross over to receive pembrolizumab 200 mg IV every 21-days for up to 1 year until progression of disease or unacceptable toxicities."
15990040|NCT02963090|Drug|Pembrolizumab|200 mg IV every 21-days until progression of disease or unacceptable toxicities.
15990041|NCT02963077|Drug|A4250|
15990042|NCT02963077|Drug|CRC (A3384)|
15990043|NCT02963077|Drug|Questran|
15990044|NCT02963077|Drug|Placebo|
15990045|NCT02963064|Biological|Humanized anti-CD117 Monoclonal Antibody (JSP191)|Procedure: single intravenous infusion of JSP191 antibody
15990046|NCT02963051|Drug|Copper|1 mg, 3 mg, 5 mg or 7 mg intravenously on cycle 1 day 1, 8 and 15
15990047|NCT02963051|Drug|Disulfiram|"80 mg three times a day
~Source of disulfiram: Cantex Pharmaceuticals"
15990048|NCT02963051|Drug|Copper gluconate|"1.5 mg three times a day
~Source of copper gluconate: Cantex Pharmaceuticals"
15990049|NCT02963038|Biological|Autologous CD19-targeting CAR T cells|Autologous CD19-targeting CAR T cells with three signaling domains derived from CD3zeta, CD28 and 4-1BB.
15990050|NCT02963025|Procedure|PEEP level|
15990051|NCT02963025|Procedure|Use of recruitment maneuvers|
15990052|NCT02963012|Other|ultrasound examination|
15990053|NCT02962999|Drug|Ketamine|After induction, patients will be received 1 mg/kg ketamine bolus, then administered 0,5 mg/kg/hour ketamine infusion intraoperatively.
15990054|NCT02962999|Drug|Saline|After induction, patients will be received saline bolus, then will be administered saline infusion intraoperatively.
15990055|NCT02962986|Drug|Norepinephrine|Norepinephrine diluted in 5% dextrose solution to a concentration of 6mcg/mL
15990056|NCT02962986|Drug|Phenylephrine|Phenylephrine diluted in 0.9% normal saline solution to a concentration of 100mcg/mL
15990057|NCT02962973|Device|CARMAT TAH|
15990058|NCT02962973|Procedure|Surgical intervention|
15990059|NCT02962960|Drug|Anifrolumab|subcutaneous administration every 2 weeks from week 0 to week 50
15990060|NCT02962960|Drug|Placebo|subcutaneous administration every two weeks from week 0 to week 50
15990061|NCT02962947|Drug|Propranolol|80 mgR propranolol once daily
15990062|NCT02962947|Drug|Placebo|placebo once daily
15990063|NCT02962934|Other|Non CRRT group|Non CRRT group:Blood samples prior to first dose of Ceftolozane-Tazobactam and at 15, 45, 1hr, 2hr 3hr 4h 5h 6h 7h 8h.
15990064|NCT02962934|Other|CRRT group|"CRRT group: Pre and Post dialysis filter blood samples taken prior to first dose of Ceftolozane-tazobactam and at 15min, 45min, 1h 2h 3h 4h 5h 6h 7h 8h.
~Ultrafiltrate samples at 1 hr,2h 4h 6h 8h"
15990065|NCT02962921|Drug|Insulin LISPRO intravenous loading|intravenous infusion of insulin Lispro.
15990066|NCT02962908|Biological|FLU-v|Subcutaneous injection in the upper arm with 500 ug of FLU-v as 0.5ml suspension in 0.01M HCl and 0.01M NaOH
15990067|NCT02962908|Biological|adjuvanted FLU-v|Subcutaneous injection in the upper arm with 500ug of FLU-v emulsified in 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection
15990068|NCT02962908|Biological|Saline|Subcutaneous injection in the upper arm with 0.5ml of saline
15990069|NCT02962908|Biological|Adjuvanted placebo|Subcutaneous injection in the upper arm with an emulsion made with 0.25ml of Montanide ISA-51 adjuvant (Seppic, France) and 0.25ml of water for injection
15990070|NCT02962895|Biological|VAY736|VAY736
15990071|NCT02962895|Other|Placebo|Placebo control
15990072|NCT02962882|Device|Mepilex Border|Multi-layer Foam Dressings
15990073|NCT02962869|Drug|BAY987517|50 μl/ cm*2 of the test article is applied directly to two sites on the skin and covered with the appropriate patch. Twenty-four (24) hours later, the patches are removed. The test sites are lightly wiped with a dry cloth/tissue and 3μl/ cm*2 of test article is reapplied directly to the skin of the test site designated for irradiation, and lightly spread over the test site. Forty-eight (48) hours later the procedure is repeated to the same test sites. This process is repeated twice weekly for a total of six exposures. (Formulation number: Z43-078)
15990074|NCT02962869|Other|Untreated skin|One site is patched without treatment as control
15990075|NCT02962856|Drug|BAY987517|50 μl/cm*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each) on the lower or mid-back. (Formulation: Z43-078)
15990076|NCT02962856|Other|Untreated Skin|This site is patched without treatment as irradiated control
15990077|NCT02962843|Behavioral|IY TCM|The Incredible Years Teacher Classroom Management program is a manualized program for teachers and staff in school and day-care settings to strengthen teacher classroom management strategies, to reduce negative behavior and promote prosocial behavior, as well as school readiness in children. Two qualified IY TCM group-leaders (facilitators) train teachers and staff in groups through six full-day workshops (a total of 42 hours).Workshop 1: Building Positive Relationships with Students, Workshop 1b: Preventing Behavior Problems -The Proactive Teacher, Workshop 2: The Importance of Teacher Attention, Coaching and Praise, Workshop 3: Motivating Children Through Incentives, Workshop 4 & 5: Decreasing Inappropriate Behavior and Workshop 6: Emotional Regulation, Social Skills & Problem Solving.
15990078|NCT02962830|Drug|Sufentanil|intra-amniotic injection of 10 micrograms of Sufentanil
15990079|NCT02962817|Other|Educational intervention|
15990080|NCT02962817|Other|Video explaining the clinical practice guidelines on low back pain|
15990081|NCT02962804|Drug|Nivolumab|240 mg per IV infusion over 60 minutes every 14 days (+/- 2 days) until disease progression or participant withdrawal from study
15990082|NCT02962804|Radiation|Radiation|Radiation to at least 1 site (up to 3) of primary or metastasis, 5 fractions - delivered over 2 weeks, starting 1-3 days post-nivolumab administration. Recommended dose range is 6 Gy-12 Gy per fraction.
15990083|NCT02962791|Procedure|Cardiac resynchronization therapy implantation|Cardiac resynchronization therapy implantation will be done for patient with symptomatic heart failure
15990084|NCT02962791|Device|Stimulation of 3 ventricular sites|Cardiac resynchronization therapy with stimulation of 3 ventricular sites
15990085|NCT02962791|Device|Stimulation of 2 ventricular sites|Cardiac resynchronization therapy with stimulation of 2 ventricular sites
15990086|NCT02962791|Device|Echocardiography|Standard Echocardiography will de bone for patient
15990087|NCT02962752|Dietary Supplement|Blackadder Juice|
15990088|NCT02962752|Other|Placebo|
15990089|NCT02962739|Drug|emtricitabine 200 mg/tenofovir alafenamide 25mg|1 tablet of Descovy contains emtricitabine 200 mg/tenofovir alafenamide 25mg
15990090|NCT02962713|Procedure|ART with Equia|Occlusal-proximal ART restorations in primary molars using Equia (Easy/Quick/Unique/ Intelligent/Aesthetic) will be performed. No local anesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with GIC (Glass Ionomer Cement). The cavity will be filled with GIC. After the press-finger technique, the excess of material will be removed and occlusion will be checked.
15990091|NCT02962713|Procedure|ART with Giomer Beautifil-Bulk Restorative|Occlusal-proximal ART restorations in primary molars using Giomer will be performed. No local anesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with Giomer Beautifil-Bulk Restorative and occlusion will be checked.
15990092|NCT02962700|Device|muscle microdialysis|Systemic haemodynamics and interstitial tissue concentrations of lactate, pyruvate, glucose and glycerol were obtained at baseline, 6, 12,18 and 24 hours after initiation of renal replacement by using muscle microdialysis.
15990093|NCT02962687|Behavioral|Care management via videoconference|12-week nurse care management for medically complex Veterans with CI delivered via videoconference
15990094|NCT02962687|Behavioral|Care management via telephone calls|12-week nurse care management for medically complex Veterans with CI delivered via telephone calls
15990095|NCT02962674|Device|prostaFix System|
15990096|NCT02962661|Other|Best Practice|Given standard of care
15990097|NCT02962661|Other|Laboratory Biomarker Analysis|Correlative studies
15990098|NCT02962661|Biological|Mesenchymal Stem Cell Transplantation|intravenous infusion (IV)
15990099|NCT02962661|Biological|Mesenchymal Stem Cell Transplantation|transendocardially (injection)
15990100|NCT02962648|Drug|Iron isomaltoside/ferric derisomaltose|"Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.
~The dose of iron isomaltoside/ferric derisomaltose for the individual subject was set to 1000 mg. The dose was diluted in 100 mL 0.9 % sodium chloride from the site's supply and administered over approximately 20 minutes using IV infusion."
15990101|NCT02962635|Device|bioelectrical impedance measurement and biomarker measurement|Measuring volume status with bioelectrical impedance measurement and comparing with biomarker level
15990102|NCT02962622|Other|High intensity interval training (HIIT)|Six weeks, three days per week (total of 18 sessions) of HIIT cycle ergometer exercise protocol
15990797|NCT02957929|Drug|Cytochrome P450 substrates|
15990103|NCT02962609|Other|Semielevated Side-lying Position-ESL|The infants in the experimental group (n = 38) were held in the ESL position. In this position, their head and trunk were elevated to an angle of 45-60◦ with the help of a pillow prepared by the researcher from the beds that were previously used in the unit and infantswere held in the side-lying position as in the breast-feeding position where their right ear faced the ceiling and the other ear faced the arms of the researcher. Their knees and hip were leaned against the researcher's arms and their head and neck were held at the same level by the researcher; whereas, their chin was held in the flexion posture mildly facing the floor. The researcher supported their head, neck, and shoulder with her left hand and controlled the bottlewith her right hand.
15990104|NCT02962609|Other|Semielevated Supine Position|The ESU position was applied to the infants in the control group (n=42). In this position, their head and trunk were elevated to an angle of 45-60◦ with the help of the same pillow that was prepared by the researcher from the beds previously used in the unit and was used in the experimental group and they was laid in the supine position in the arms of the researcher. Their head and neck were held at the same level by the researcher, whereas their chin was held in the flexion posture mildly facing the floor. The researcher supported their head, neck, and shoulder with her left hand and controlled the bottlewith her right hand.
15990105|NCT02962596|Other|ADNEXMR SCORING system|Scoring system used to standardize the imaging report for sonographically indeterminate adnexal masses.
15990106|NCT02962583|Other|Weight loss|
15990107|NCT02962583|Drug|Probiotic Formula|
15990108|NCT02962583|Drug|Placebos|
15990109|NCT02962570|Device|On Demand Oxygen Delivery|Supplemental oxygen flow is controlled such that it is on only during inhalation.
15990110|NCT02962570|Device|Traditional, Always-On, Oxygen Delivery|Supplemental oxygen flow is constantly on, irrespective of whether the patient is inhaling or exhaling.
15990111|NCT02962570|Device|Oxygen Flow Stopped|Supplemental oxygen flow is stopped completely for a brief period to allow undisturbed end-tidal oxygen and CO2 measurements
15990112|NCT02962557|Device|NM3, Phillips Medical, Wallingford CT: verbal prompts to breathe with an optional shoulder shake|The device used is the NM3 by Phillips Medical, Wallingford CT. The prompting for breaths will include a recorded voice played at 100 decibels played by a speaker placed within 4 feet of the patient's head. If successful breath response is monitored by the patient monitors but no additional subsequent breaths occur within 20 seconds, the verbal prompt will be repeated for the patient to breathe. If the verbal prompting does not result in a breath detected by the patient monitors, the verbal prompt will be repeated within 20 seconds, optionally accompanied by a shoulder shake from the shoulder massager.
15990113|NCT02962544|Procedure|FS-SMILE|The procedure will be performed using an established technique. the patient's eye will be centered and docked with the curved interface cone before application of suction fixation.The laser will be activated for photo-dissection in the following sequence: first the posterior surface of the refractive lenticule then the lenticule border then The anterior surface of the refractive lenticule which extended beyond the posterior lenticule diameter by 0.5 mm to form the anterior flap and is followed by a rim cut. After the suction is released, a Siebel spatula is inserted under the cap near the hinge before the cap is separated. The edge of the refractive lenticule is separated from the stromal bed with a sinsky hook and the posterior border of the lenticule gently separated with the Siebel spatula. The lenticule is then grasped with forceps through the small incision.
15990114|NCT02962544|Procedure|FS- LASIK|LASIK procedure Each LASIK procedure will be performed using a standard, established technique. Under topical anesthesia and standard draping, a lid speculum is used to retract the eyelids. A superiorly hinged 100 μm thick flap will be created using the WaveLight FS200 (Alcon Laboratories, Inc.) With inverted side cut (115 ̊) .Excimer laser ablation is then performed using WaveLight EX500 excimer laser (Alcon Laboratories, Inc.).After ablation, the flap will be carefully repositioned, and postoperative medications are commenced.
15990115|NCT02962544|Device|Visumax device|
15990116|NCT02962544|Device|FS 200 device|
15990117|NCT02962531|Drug|IX-01 caplets 1600 mg (4 x 400 mg), fasted|oral dose under fasted conditions
15990118|NCT02962531|Drug|IX-01 caplets 1600 mg (4 x 400 mg), fed|oral dose under fed conditions
15990119|NCT02962531|Drug|IX-01 aqueous dispersion 1600 mg (20 mL), fasted|oral dose under fasted conditions
15990120|NCT02962518|Device|Pressure Device|"Patients undergo surgery using the fillet technique and intra-lesional injections of triamcinolone 10mg /ml every 4 to 6 weeks for 6 months and they are additionally treated with a non-customized Pressure Device. The standardized clips (K. Egner, Dental Technique, Neu-Ulm, Germany) used in our study is available in two different sizes for smaller or larger defects. According to the guidelines of the German Society of Dermatology, patients are advised to wear the clip at least 16 hours per day. Medically approved transparent acrylate is used so that change in skin color and therefore amount of pressure can be observed at all times. Allergic or toxic skin involvement can be visualized through the transparent surface. Adjusting of the clip is done with one or two screws."
15990121|NCT02962518|Procedure|Fillet Technique|"Patients undergo surgery using the fillet technique. To prevent the remaining skin from further damage, the meticulous skin preparation is performed either using the microscope or magnifying glasses. The keloid is peeled out of the excessive skin pocket. If necessary skin trimming is performed and non-resorbable monofilament single sutures are placed."
15990122|NCT02962518|Drug|Triamcinolone|All patients received intra-lesional injections of tiamcinolone 10mg/ml every 4 to 6 weeks for 6 months.
15990123|NCT02962492|Drug|Exenatide/Exenatide extended release|Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
15990124|NCT02962492|Drug|Dapagliflozin|Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
15990125|NCT02962492|Drug|Placebo|Eighty (80) patients with T1D will be enrolled and randomized into 4 groups(20 each) to receive placebo, or dapagliflozin, or exenatide (5µg acutely)/Exenatide extended release (long term), or exenatide (5µg acutely)/Exenatide extended release (long term) and dapagliflozin treatments acutely and for 12 weeks
15990126|NCT02962466|Other|CC-Test|classification of the oocyte based on the expression pattern observed in the cumulus cells
15990127|NCT02962453|Device|Morning walk|gait training with Morning walk three times during 5 minutes with 5 minute break a day over 5 weekdays
15990128|NCT02962453|Device|Ground Walker|gait training with ground walker until corresponding 200 steps during 5 minutes with 5 minute break a day over 5 weekdays
15990129|NCT02962440|Drug|somapacitan|All subjects will receive one subcutaneous (s.c., under the skin) dose of somapacitan containing [3H]-somapacitan
15990130|NCT02962427|Drug|Sphenopalatine ganglion Block|
15990131|NCT02962427|Procedure|Epidural blood patch|
15990133|NCT02962401|Drug|Obinutuzumab|"6 cycles every 28 days Cycle 1 :Obinutuzumab 1000mg I.V.(2 parts) 100mg day 1 and 900mg day 2 day 1, 8 and 15
~Cycle 2 - 6 :
~Obinutuzumab 1000mg I.V.day 1"
15990134|NCT02962401|Drug|Idelalisib|"6 cycles every 28 days
~Cycle 1 :
~Idelalisib 150 mg x 2 p.o. day 1 to 28 Cycle 2 - 6 Idelalisib 150 mg x 2 p.o. day 1 to 28 Consolidation Idelalisib alone 150 mg twice a day until day 672 = 2 years after the beginning of the treatment"
15990135|NCT02962388|Drug|Anagrelide|Anagrelide in the study, according to the investigator decision fom day 1 to 48 months
15990136|NCT02962388|Drug|Ruxolitinib (JAKAVI®)|Ruxolitinib (JAKAVI®) - Novartis. Tablets 5 mg. Starting dose 10 mg BID, orally. To be increased or decreased (5 or 10 mg steps) per standardized dosing Maximum dose 25 mg BID. fom day 1 to 48 months
15990137|NCT02962388|Drug|IFNα/ PegIFNα|IFNα/ PegIFNα in the study, according to the investigator decision fom day 1 to 48 months
15990138|NCT02962375|Dietary Supplement|Active|100% orange juice with orange pomace fiber
15990139|NCT02962375|Dietary Supplement|Control|100% orange juice
15990140|NCT02962336|Drug|Torrent's Olmesartan medoxomil, Amlodipine and Hydrochlorothiazide Tablets|Oral, crossover
15990141|NCT02962336|Drug|Tribenzor Tablets of Daichi Sankyo Inc, USA|Oral, crossover
15990142|NCT02962323|Drug|Torrent's Rosuvastatin Calcium Tablets 40 mg|Oral, crossover
15990143|NCT02962323|Drug|Crestor 40 mg Tablets of AstraZeneca Pharmaceuticals LP, USA|Oral, crossover
15990144|NCT02962310|Drug|Torrent's Rosuvastatin Calcium Tablets 40 mg|oral, crossover
15990145|NCT02962310|Drug|Crestor 40 mg Tablets of AstraZeneca LP, USA|oral, crossover
15990146|NCT02962297|Drug|Vitamin E softgel|All participants receive standardized recommendations for life-style modification (Diet modification, weight loss, exercise).
15990147|NCT02962297|Drug|Placebo|"All participants receive standardized recommendations for life-style modification (Diet modification, weight loss, exercise).
~Height and weight, waist-to-hip ratio Review of diet and exercise"
15990148|NCT02962284|Drug|abiraterone acetate with Methylprednisolone|YONSA 500 mg (4 x 125 mg qd) with Methylprednisolone (4 mg bid)
15990149|NCT02962271|Device|Musculoskeletal Ultrasound|Musculoskeletal ultrasound (MSUS) of the lower limbs' entheses were performed
15990150|NCT02962258|Drug|Torrent's Olmesartaan medoxomil, Amlodipine and Hydrochlorothiazide Tablets|oral, crossover
15990151|NCT02962258|Drug|Tribenzor of Daichi Sankyo Inc. USA|oral, crossover
15990152|NCT02962245|Drug|berberine|
15990153|NCT02962245|Drug|regular treatment|such as 5-ASA,immunomodulating/suppressive agents or Anti-TNF therapy
15990154|NCT02962232|Device|Paclitaxel Releasing Peripheral Balloon Dilatation Catheter|treatment group
15990155|NCT02962232|Device|PTA catheter|control group
15990156|NCT02962219|Behavioral|Pre-operative Exercise Programme (my-PEP)|A pre-operative personalised exercise programme (my-PEP) consisting of: 1) actions to promote exercise, using behavioural change techniques (BCTs), 2) home inspiratory muscle training (IMT), 3) a home exercise programme (HEP) - which is also current standard care, 4) a 4 week hospital-supervised aerobic and muscle strengthening programme (Hos-PEP) .
15990157|NCT02962219|Behavioral|Home Exercise Programme (HEP)|Written advice on exercise at home
15990158|NCT02962206|Device|Point-of-care ultrasound|After the fracture reduction maneouver, the physician will assess residual dorsal angulation using point-of-care ultrasound. If deemed adequate, the physician will progress to immobilization. If the reduction is not adequate, the physician will attempt further reduction at their discretion.
15990159|NCT02962206|Procedure|Closed fracture reduction|The distal radius fracture will be reduced with using a combination of local anesthetic, sedation, reduction maneouvers and immobiliazation at the discretion of the treating physician
15990160|NCT02962180|Device|Dermabrasion with dermaroller|o The dermaroller is passed on the treated depigmented area. This technique is based on tiny microwounds performed using 540 microneedles (0.2mm length) which should allow the penetration of the suspension cells into the epidermis to obtain a good repigmentation.
15990161|NCT02962167|Biological|Modified Measles Virus|Administration of MV-NIS either into the tumor bed, if surgery to remove local tumor
15990162|NCT02962167|Biological|Modified Measles Virus Lumbar Puncture|Administration of MV-NIS into the cerebrospinal fluid via lumbar puncture
15990163|NCT02962154|Radiation|Coronary CT Angiography|The coronary CT angiography will assess for coronary artery stenosis, plaque characteristics, calcifications, and other factors.
15990164|NCT02962154|Other|Mood Symptom Scale|"Some or all of the following questionnaires will be conducted to assess mood symptoms:
~Beck Depression Inventory, Hamilton Depression Rating Scale (24-item), Montgomery Asberg Depression Rating Scale (MADRS), Mood and Anxiety Symptom Questionnaire (MASQ), QIDS, Young Mania Rating Scale"
15990165|NCT02962154|Other|Anxiety Symptom Scale|"Some or all of the following questionnaires will be conducted to assess anxiety symptoms:
~Beck Anxiety Inventory, Spielberger State/Trait Anxiety Inventory (STAI), GAD-7 Anxiety Questionnaire, Penn State Worry Questionnaire (PSWQ)"
15990166|NCT02962154|Other|Chronic Stress Inventories|"Some of all of the following questionnaires will be conducted to assess chronic stress:
~Chronic stress inventories: Cohen Perceived Stress Scale, Holmes and Rahe Stressful Life Events Scale, Karasek Job Strain Questionnaire, Conner-Davidson Resilience Scale, PTSD Checklist"
15990167|NCT02962154|Other|Psychosocial Function Questionnaires|"Some of all of the following questionnaires will be conducted to assess psychosocial function:
~Type A Personality Scale, NEO Personality Inventory, Positive and Negative Affect Schedule (PANAS), Behavioral Inhibition/Behavioral Approach Scale (BIS/BAS)"
15990254|NCT02961751|Drug|Ciprofloxacin|Directly observed treatment with a single dose of ciprofloxacin 500 mg orally with or without food.
15990376|NCT02960880|Drug|Phenprocoumon (branded and generics)|Individually adjusted dose
15991964|NCT02949895|Drug|BMS-986012|
15990168|NCT02962154|Other|General Health and quality of life questionnaires|"Some of all of the following questionnaires will be conducted to assess quality of life:
~EQ-5D Health Questionnaire, Seattle Angina Questionnaire, International Index of Erectile Function (ILEF-5), Pittsburgh Sleep Quality Scale, Morningness Eveningness Questionnaire"
15990169|NCT02962154|Other|Magnetic Resonance Imaging|First, subjects will undergo a resting cardiac MR perfusion study to establish baseline (pre-stress) measures of cardiovascular function. Second, subjects will undergo a series of brain magnetic resonance imaging studies (T1-weighted anatomical MRI, diffusion tensor imaging, resting state functional MRI) to establish baseline (pre-stress) measures of brain function and structural correlates. Third, investigators will use a well-validated cognitive task to induce mental stress by testing subjects' working memory for a series of emotionally arousing or neutral images, while repeating the functional MRI scan. Finally, subjects will undergo a repeat cardiac MR perfusion study while being tested on the same mental stress task.
15990170|NCT02962141|Device|Paclitaxel Releasing Peripheral Balloon Dilatation Catheter|Treatment group
15990171|NCT02962141|Device|Balloon Dilatation Catheter|Control group
15990172|NCT02962128|Dietary Supplement|High Linoleic Acid (LA) Diet|Volunteers will be randomly assigned to consumption of a high [10% energy] LA-containing diet for 12 weeks.
15990173|NCT02962128|Dietary Supplement|Low Linoleic Acid (LA) Diet|Volunteers will be randomly assigned to consumption of a low [2.5% energy] LA-containing diet for 12 weeks.
15990174|NCT02962115|Behavioral|Decision Aid Invitation|electronic invitation to complete web-based decision aid
15990175|NCT02962102|Drug|Calcifediol|Calcifediol 400mcg PO/NGT/OGT x 1, followed by 200mcg PO/NGT/OGT daily x 4
15990176|NCT02962102|Drug|Calcitriol|Calcitriol 4mcg PO/NGT/OGT daily x 5
15990177|NCT02962102|Drug|Placebos|Placebo (medium chain triglyceride oil) daily x 5
15990178|NCT02962089|Dietary Supplement|Branched chain amino acids (BCAA)|
15990179|NCT02962089|Dietary Supplement|Placebo|
15990180|NCT02962076|Radiation|[C-11] Meta-hydroxyephedrine radioactive tracer (MHED)|this tracer detects the distribution of sympathetic nerve fibers in the left ventricle
15990181|NCT02962063|Biological|durvalumab|Durvalumab can be given irrespective of CBC, at the discretion of the treating physician.
15990182|NCT02962063|Drug|carboplatin AUC 2/paclitaxel|
15990183|NCT02962063|Radiation|External beam radiation (EBRT)|Radiation will be delivered starting on a Monday or Tuesday between Days 29-30, based on the first induction durvalumab dose administered on Day 1. Patients will be treated 5 days/week at 1.80 Gy/day, to a total planned dose of 50.4Gy in 28 fractions. Induction Day 15 has a -1/+2 day window, and Day 29 has a -1/+1 day window.
15990184|NCT02962063|Procedure|esophagogastrectomy|Patients undergo surgical resection 6-8 weeks after the completion of chemoradiation.
15990185|NCT02962063|Drug|Tremelimumab|Tremelimumab will be administered once at 300 mg on Day 29 prior to chemoradiation only.
15990186|NCT02962050|Procedure|Videofluoroscopic Swallowing Study (VFSS)|Videofluoroscopic swallowing study will be performed to measure oropharyngeal swallowing
15990187|NCT02962050|Device|Voluntary Peak Cough Flow Testing|Voluntary peak cough flow testing will be performed to determine the peak expiratory flow (PEF) and volume of air expelled (FEV1) during voluntary coughing.
15990188|NCT02962050|Device|Iowa Oral Performance Instrument|The Iowa Oral Performance Instrument (IOPI) is a device that measures the peak pressure performance of lingual strength and endurance via the action of a bulb placed on the hard palate.
15990189|NCT02962050|Drug|Capsaicin Challenge|"A capsaicin challenge with three randomized blocks of 0, 50, 100, 200, and 500 μM capsaicin. The capsaicin will be dissolved in a vehicle solution consisting of 80% physiological saline, and 20% ethanol. Participants will be given the instruction cough if you need to prior to capsaicin delivery.The solution will be administered automatically upon detection of an inspired breath and there will be a minimum of one minute between each trial. This is to test the reflexive cough testing for upper airway sensitivity and motor thresholds."
15990190|NCT02962050|Device|Pulmonary Function Testing|Pulmonary Function testing will be performed using conventional methods and will include the following outcomes: forced vital capacity (FVC), maximum inspiratory pressure (MIP), and maximum expiratory pressure (MEP) expressed as a percentage of predicted values.
15990191|NCT02962050|Other|Eating Assessment Tool 10|The Eating Assessment Tool-10 will be used for participant reporting of swallowing system severity.
15990192|NCT02962050|Other|The Center for Neurologic Study Bulbar Function Scale|The Center for Neurologic Studies Bulbar Function Scale (CNS-BFS) will be used to report bulbar function in study participants.
15990193|NCT02962037|Other|Melatonin and light therapy|
15990194|NCT02962024|Drug|Morphine Sulfate|
15990195|NCT02962024|Drug|Bupivacaine Hydrochloride|
15990196|NCT02962011|Device|Knotless barbed suture|uterine incision closure
15990197|NCT02962011|Device|polyglactin 910|uterine incision closure
15990198|NCT02961998|Drug|Celecoxib|Patients from experimental group will take celecoxib, except for sorafenib
15990199|NCT02961998|Drug|Sorafenib|Each group will receive sorafenib as basic treatment.
15990200|NCT02961972|Dietary Supplement|monohydrate and micronized creatine|oral supplementation with creatine
15990201|NCT02961972|Other|placebo|oral supplementation with maltodextrin (control group)
15990202|NCT02961959|Procedure|Surgery|Arthrodesis of SI-joints, Physiotherapy
15990203|NCT02961959|Other|Non-surgery|Physiotherapy
15990204|NCT02961946|Drug|Nitroglycerin|Patients grouped in sublingual administration (group 1 and 2) will receive Nitroglycerin during the cCTA scan by the MD after the Calcium scoring scan and 5 minutes before the actual cCTA scan. Patients categorized to transdermal administration will receive Nitroglycerin 1 hour before the CT examination. The patch will be placed on the chest or the upper arm.
15990205|NCT02961933|Other|Apneic oxygenation|Nasal cannula apneic oxygenation
15990206|NCT02961933|Other|Pre-oxgenation with NRB, NIPPV, BVM|Pre-oxygenation with non-rebreather mask, non-invasive positive pressure ventilation, or bag-valve mask
15990207|NCT02961920|Device|IE ratio 1:1|Set an I:E ratio1:1 in the mechanical ventilator during spine surgery in the prone position in obese patients.
15990208|NCT02961920|Device|IE ratio 1:2|Set an I:E ratio1:2 in the mechanical ventilator during spine surgery in the prone position in obese patients.
15990330|NCT02961127|Other|Venous blood was collected|Venous blood was collected by standard vein puncture in fasting condition
15990209|NCT02961907|Procedure|PEPCI|"Both parents will receive:
~consultation with a psychiatrist then psychologist follow-up if required, addiction specialist physician consultation then liaison nurse follow-up if required
~endocrinologist consultation then dietitian follow-up if required
~actiphysician consultation and follow-up if required This program will be added to the usual routine course Both parents will receive a 3 months personalized follow-up if required from the multi disciplinary consultation and before the first ART attempt."
15990210|NCT02961894|Device|Revolution™ Peripheral Atherectomy System|The Rex Medical Revolution™ Peripheral Atherectomy System is a minimally invasive catheter-based atherectomy system used to treat patients who suffer from PAD. This system is designed to treat a broad range of plaque types both above and below the knee and may address many of the limitations associated with existing treatment options.
15990211|NCT02961881|Drug|blinatumomab|Drug used as a treatment for relapsed/refractory B-cell precursor ALL
15990212|NCT02961868|Other|Abdominal and supra-aortic trunks vascular imaging|Abdominal and supra-aortic trunks vascular imaging (angiography, CT-angiography or MR-angiography) will be performed 3 years after inclusion. This imaging will be compare to initial imaging (which is a part of usual care, not an intervention added by the study) in order to assess FMD progression.
15990213|NCT02961868|Genetic|Blood sampling (genetic)|A sample of blood will be taken to meet the objective of estimating the rate of genetic polymorphism that may influence disease progression or be associated with complications.
15990214|NCT02961868|Other|Blood sampling (biomarkers)|A sample of blood will be taken to biomarkers analysis to meet the primary objective of assessing the risk factors for progression of FMD lesions.
15990215|NCT02961868|Other|Urine sampling|A sample of urine will be taken to biomarkers analysis to meet the primary objective of assessing the risk factors for progression of FMD lesions.
15990216|NCT02961855|Drug|anesthesics plus antiinflammatory, CLIFE1|anesthesics plus antiinflammatory, CLIFE1 topical gel containing lidocaine plus diclofenac anesthesics plus antiinflammatory
15990217|NCT02961855|Drug|local anesthesics, CLIFE2|local anesthesics, CLIFE2 topical gel containing lidocaine local anesthesics
15990218|NCT02961842|Drug|500 mL Colloid Preload|6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 500 mL will be rapidly infused before spinal anesthesia
15990219|NCT02961842|Procedure|Spinal Anesthesia|Performed at the L3-L4 or L4-L5 interspace using 27- or 25-gauge spinal needle
15990220|NCT02961842|Drug|Intrathecal Bupivacaine|Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space
15990221|NCT02961842|Drug|Intrathecal Fentanyl|Fentanyl 15 µg will be administered in the subarachnoid space
15990222|NCT02961842|Drug|500 mL Crystalloid Coload|Ringer acetate 500 mL will be rapidly infused immediately after intrathecal injection
15990223|NCT02961842|Drug|1000 mL Crystalloid Coload|Ringer acetate 1000 mL will be rapidly infused immediately after intrathecal injection
15990224|NCT02961842|Procedure|Cesarean Delivery|Lower segment cesarean section using the Pfannenstiel incision
15990225|NCT02961842|Radiation|Ultrasound Assessment of the Inferior Vena Cava|The inferior vena cava largest and smallest diameters will be measured proximal to the opening of the hepatic veins in the longitudinal axis with the M-mode using a 5-2 MHz curved array ultrasound probe placed longitudinally in the subxiphoid region
15990226|NCT02961842|Drug|Intravenous Ephedrine|Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 90%, 80%, and 70% of baseline, respectively.
15990227|NCT02961829|Drug|Maraviroc|antiretroviral intensification
15990228|NCT02961829|Drug|Dolutegravir|antiretroviral intensification
15990229|NCT02961829|Biological|Dendritic Cell Vaccine|Therapeutic vaccination
15990230|NCT02961829|Drug|Auranofin|purging
15990231|NCT02961829|Drug|Sirtuin Histone deacetylase inhibitor|latency disruption
15990232|NCT02961816|Drug|Palifermin|Palifermin, per standard of care, on Days -13 to -11 and on Days 0, +1, and +2.
15990233|NCT02961816|Drug|Panobinostat|20 mg by mouth daily from Day -9 to -2.
15990234|NCT02961816|Drug|Gemcitabine|Gemcitabine administered as a loading dose of 75 mg/m2 by vein followed by prolonged infusion over 4.5 hours of 2,700 mg/m2 (total daily dose 2,775 mg/m2) on Days -8 and -3.
15990235|NCT02961816|Drug|Busulfan|"Busulfan test dose administered on Day -10. Test dose of 32 mg/m2 based on actual body weight administrated over 60 minutes. Busulfan pharmacokinetics performed with the test dose and the first dose on Day-8. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK."
15990236|NCT02961816|Drug|Melphalan|60 mg/m2 by vein on Days -3 and -2.
15990237|NCT02961816|Drug|Rituximab|375 mg/m2 by vein on Day -9 for patients with CD20+ tumors.
15990238|NCT02961816|Drug|Dexamethasone|8 mg by vein twice a day from Day -8 AM to Day -2 PM.
15990239|NCT02961816|Drug|Caphosol|Caphosol oral rinses 30 mL four times a day used from Day -8.
15990240|NCT02961816|Drug|Glutamine|Oral Glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
15990241|NCT02961816|Other|Oral Cryotherapy (ice chips)|Oral cryotherapy (ice chips) from 30 minutes before until 2 hours after each Melphalan infusion.
15990242|NCT02961816|Drug|Pyridoxine|100 mg by vein or mouth three times a day from Day -1.
15990243|NCT02961816|Biological|Stem Cell Infusion|Stem cells administered by vein on Day 0.
15990244|NCT02961816|Drug|G-CSF|G-CSF administered as an injection just under the skin, per standard of care ,1 time each day starting on Day +5 until blood cell levels return to normal.
15990245|NCT02961803|Drug|MD1003 100 mg capsule|
15990246|NCT02961803|Drug|Placebo|
15990247|NCT02961790|Drug|Oxybutynin Chloride|Given PO
15990248|NCT02961790|Other|Placebo|Given PO
15990249|NCT02961790|Other|Quality-of-Life Assessment|Ancillary studies
15990250|NCT02961790|Other|Questionnaire Administration|Ancillary studies
15990251|NCT02961777|Other|implementation of care pathway|implementation of a care pathway
15990252|NCT02961764|Drug|Usual Care|Usual care as prescribed by the physician as standard of care in clinical practice for the treatment of ABSSSI.
15990253|NCT02961764|Drug|Dalbavancin|Dalbavancin administered as a single IV dose of 1500 mg over 30 minutes.
15990377|NCT02960854|Biological|Nivolumab|Specified dose on specified days
15990255|NCT02961738|Behavioral|Cognitive Analytic Therapy (CAT)|Cognitive Analytic Therapy (CAT) is a relational, integrative and time-limited psychotherapy. This is a study with two active arms. Therefore in the full CAT arm the participants receive the full therapy, but in the CAT-NR arm participants get CAT with the narrative reformulation aspect removed.
15990256|NCT02961725|Biological|UCMSC|UCMSC: umbilical cord mesenchymal stem cells 3-5*10^7/5 ml
15990257|NCT02961712|Biological|NK cells|single intravenous injection of NK cells (0.9~1*10^9)
15990258|NCT02961712|Biological|amniotic epithelial cells|single intrathecal injection of amniotic epithelial cells
15990259|NCT02961699|Device|Transpose ® RT System|adipose-derived stem cell therapy
15990260|NCT02961699|Other|debridement/dressing of wound|standard of care debridement and wound dressing
15990261|NCT02961686|Radiation|Patients affected by prostate cancer|Patients affected by prostate cancer and treated with a multidisciplinary approach: it includes exclusive radiotherapy, psychological and andrologic evaluation.
15990262|NCT02961673|Biological|HU-014 Inj|Clostridium botulinum type A
15990263|NCT02961673|Biological|Botox Inj|Clostridium botulinum type A
15990264|NCT02961660|Drug|Odalasvir|Participants will receive odalasvir 25 mg tablet, orally.
15990265|NCT02961647|Procedure|Mitral valve repair|The intervention is NOT related to the study design. It is a description of patients undergoing surgery vs. not undergoing surgery and this decision is made according to current guidelines (patients are not randomized).
15990266|NCT02961634|Device|Nailner 2 in 1|Nailner 2 in 1 is a combination of assets that alter the pH of the nail and is used as an adjunct in the treatment of onychomycosis.
15990267|NCT02961634|Drug|Ciclopirox 8%|Ciclopirox 8% is a glaze used in the treatment of onychomycosis
15990268|NCT02961621|Behavioral|Stress Reduction Training for 9-1-1 Telecommunicators|
15990269|NCT02961608|Drug|Drug conversion from Tacrolimus (Prograf® or Adoport®) to LCP-Tacrolimus (Envarsus®)|Drug conversion from Tacrolimus (Prograf® or Adoport®) to LCP-Tacrolimus (Envarsus®)
15990270|NCT02961595|Biological|Oral Polio Vaccine (OPV)|Serial Oral Polio Vaccine (OPV) was given to intervention group instead of inactivated poliovirus vaccine (IPV).
15990271|NCT02961582|Device|Sacral Neuromodulation|"SNM starts with a screening phase. In this phase a tined lead is inserted into the third sacral foramen and attached to an external stimulator, after which the patient enters a four-week stimulation test period. If the screening phase is successful (defecation frequency (DF) ≥3 a week), the external stimulator is changed for a pacemaker that is implanted in the buttocks. If the screening phase is unsuccessful (DF <3 a week), the lead is explanted.
~Patients in the intervention group are asked to limit the use of additional conservative treatments for constipation (such as laxatives and colonic irrigation) to what is necessary to relieve (the most severe) complaints. What is necessary to relieve complaints is determined by the patient."
15990272|NCT02961582|Other|Personalized Conservative Treatment|The control group will receive the best and least invasive alternative treatment, which is personalized conservative treatment (PCT). PCT includes, a combination of laxative/medication use and/or colonic irrigation, depending on the preferences of the patient. Use of PCT will be documented.
15990273|NCT02961569|Procedure|sputum collection for acid fast bacilli|spontaneous or post fiberoptic bronchoscopy sputa
15990274|NCT02961556|Drug|AJG555|Participants will receive 1 to 6 sachets daily per participants' age and conditions.
15990275|NCT02961543|Other|Isokinetic eccentric exercises|"The individuals of both groups will be submitted to the same physiotherapeutic protocol with objectives of analgesia, reduction of edema, recovery of range of motion, proprioception and functionality.
~45 days after ACL reconstruction, subjects randomly allocated to this arm will be submitted to a muscle rehabilitation program based on isokinetic eccentric exercise lasting six weeks, with training frequency of two sessions per week, separated by a minimum interval of 72 hours."
15990276|NCT02961543|Other|Isotonic eccentric exercises|"The individuals of both groups will be submitted to the same physiotherapeutic protocol with objectives of analgesia, reduction of edema, recovery of range of motion, proprioception and functionality.
~45 days after ACL reconstruction, subjects randomly allocated to this arm will be submitted to a muscle rehabilitation program based on isotonic eccentric exercise lasting six weeks, with training frequency of two sessions per week, separated by a minimum interval of 72 hours."
15990277|NCT02961530|Other|Isokinetic eccentric exercises|"The individuals of both groups will be submitted to the same physiotherapeutic protocol with objectives of analgesia, reduction of edema, recovery of range of motion, proprioception and functionality.
~15 days after partial menisectomy, subjects randomly allocated to this arm will be submitted to a muscle rehabilitation program based on isokinetic eccentric exercise lasting six weeks, with training frequency of two sessions per week, separated by a minimum interval of 72 hours."
15990278|NCT02961530|Other|Isotonic eccentric exercises|"The individuals of both groups will be submitted to the same physiotherapeutic protocol with objectives of analgesia, reduction of edema, recovery of range of motion, proprioception and functionality.
~15 days after partial menisectomy, subjects randomly allocated to this arm will be submitted to a muscle rehabilitation program based on isotonic eccentric exercise lasting six weeks, with training frequency of two sessions per week, separated by a minimum interval of 72 hours."
15990279|NCT02961517|Other|Questionnaire|Anonymous questionnaire collecting basic sociodemographic data about the participant and information regarding their preferences for the method of delivery format of patient education information
15990280|NCT02961504|Biological|HLCM051|Within 18 to 36 hours after the onset of ischemic stroke, subjects will receive a single dose of 1.2 billion HLCM051 cells to be intravenously administered
15990281|NCT02961504|Biological|Placebo|Within 18 to 36 hours after the onset of ischemic stroke, subjects will receive a single dose of placebo to be intravenously administered
15990282|NCT02961491|Drug|Ultratrace Iobenguane I131|Subjects will receive a dosimetry dose of AZEDRA and will undergo 3 whole body scans. If the scans indicate tumor avidity for AZEDRA, the subjects will receive up to 2 therapeutic doses of AZEDRA each at 500 mCi (or 8 mCi/kg, for subjects weighing 62.5 kg or less) approximately 90 days apart.
15990283|NCT02961478|Drug|IOHEXOL|Estimate iohexol clearance at the end of stay in intensive care for patients who had an episode of acute renal failure.
15990331|NCT02961114|Procedure|Microcannula Harvest Adipose|Use of closed syringe microcannula harvest of autologous AD-tSVF from subdermal adipose deposits to create a AD-cSVF
15990378|NCT02960841|Other|Intracavitary Manual Lymphatic Drainage|
15990284|NCT02961465|Device|Sacral Neuromodulation|"SNM starts with a screening phase. In this phase a tined lead is inserted into the third sacral foramen and attached to an external stimulator, after which the patient enters a four-week stimulation test period.
~If the screening phase is successful (defecation frequency (DF) ≥3 a week), the external stimulator is changed for a pacemaker that is implanted in the buttocks. If the screening phase is unsuccessful (DF <3 a week), the lead is explanted. Patients are asked to limit the use of additional conservative treatments for constipation (such as laxatives and colonic irrigation) to what is necessary to relieve (the most severe) complaints. What is necessary to relieve complaints is determined by the patient."
15990285|NCT02961452|Other|Cross reaction detection|
15990286|NCT02961439|Behavioral|Epworth Richmond's Echocardiography Focused Year|a year long echo teaching program
15990287|NCT02961426|Drug|sofosbuvir + ravidasvir|combination of sofosbuvir + ravidasvir
15990288|NCT02961400|Other|PUSH text messages|The intervention is designed to remind participants of treatment components.
15990289|NCT02961400|Other|PULL text messages|The intervention is designed to remind participants to recall treatment components.
15990290|NCT02961400|Behavioral|TranS-C|The Transdiagnostic Sleep and Circadian Intervention (TranS-C) integrates evidence-based treatments derived from basic research on the circadian system.
15990291|NCT02961400|Behavioral|PE|Psychoeducation on the inter-associations between sleep, diet, exercise and stress.
15990292|NCT02961387|Device|Hydrogen generator treatment|The patients mainly used the hydrogen generator with nebulizer for inhalation of hydrogen-oxygen mixed gas.
15990293|NCT02961387|Device|Oxygen-making machine treatment|The patients mainly used medical molecular sieve oxygen-making machine for oxygen inhalation.
15990294|NCT02961374|Drug|Erlotinib|Given PO
15990295|NCT02961374|Drug|Erlotinib Hydrochloride|Given PO
15990296|NCT02961361|Drug|ropivacaine|40 ml 0.375% ropivacaine was injected after Locating brachial plexus.
15990297|NCT02961361|Drug|ropivacaine mixed with dexmedetomidine|40 ml 0.375% ropivacaine mixed with dexmedetomidine was injected after Locating brachial plexus.
15990298|NCT02961348|Other|Early start of NOAC|Initiation of NOAC up until day 4 after acute ischemic stroke in patients with atrial fibrillation
15990299|NCT02961348|Other|Late start of NOAC|Initiation of NOAC between day 5 and day 10 after acute ischemic stroke in patients with atrial fibrillation
15990300|NCT02961335|Procedure|Bronchoscopy|Patient who need to undergo bronchoscopy. During bronchoscopy, biopsy sampling and Confocal microendoscopy will be done
15990301|NCT02961335|Procedure|Confocal microendoscopy|Confocal microendoscopy will be performed during this initial bronchoscopy
15990302|NCT02961335|Procedure|Biopsy sampling|Patient who need to undergo bronchoscopy. During bronchoscopy, biopsy sampling and Confocal microendoscopy will be done
15990303|NCT02961322|Other|lobo-isthmectomy assisted robot|
15990304|NCT02961309|Drug|THC|1 High-Potency THC (Dosage = 10mg) cigarette (oral smoking) on one day and 1 Placebo on the other day.
15990305|NCT02961296|Other|No intervention|No intervention will be needed.
15990306|NCT02961283|Drug|ASN003 ascending doses|
15990307|NCT02961283|Drug|ASN003 MTD|The highest safe and well tolerated dose selected from the doses tested in Part A of the study.
15990308|NCT02961270|Drug|Icotinib|Icotinib will be given orally 250 mg thrice per day until disease progression, or untolerated toxicity
15990309|NCT02961257|Drug|cabazitaxel|"Arm A : cabazitaxel 25 mg/m² on Day 1 of a 3-week cycle plus daily prednisone or
~Arm B: cabazitaxel 16 mg/m² on Day 1 and Day 15 of a 4-week cycle plus daily prednisone.
~Treatment will be continued for a maximum of 10 cycles unless there is documented disease progression or unacceptable toxicity.
~Standard cabazitaxel premedication will be used"
15990310|NCT02961257|Drug|Prednisone|Arm A:plus prednisone 10 mg orally given daily for a maximum of 10 cycles Arm B: plus prednisone 10 mg orally given per day up to 10 cycles
15990311|NCT02961257|Drug|Granulocyte colony-stimulating factor (G-CSF)|Primary prophylaxis with Granulocyte Colony-Stimulating Factor (G-CSF) will be injected from Day 3 to Day 7 after every administration of cabazitaxel
15990312|NCT02961244|Other|Prewarming and perioperative warming with Forced Air Warming device and its blankets.|
15990313|NCT02961244|Device|Forced Air Warming blanket|
15990314|NCT02961231|Biological|PCV 2p+1|introduction of PCV in a reduced dosing 2p+1 schedule
15990315|NCT02961231|Biological|PCV 3p+0|introduction of PCV in a reduced dosing 3p+0 schedule
15990316|NCT02961231|Biological|PCV 1p+1|introduction of PCV in a reduced dosing 1p+1 schedule
15990317|NCT02961231|Biological|PCV 0p+1|introduction of PCV in a reduced dosing 0p+1 schedule
15990318|NCT02961218|Drug|ACZ885|Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects
15990319|NCT02961218|Drug|Placebo|Monthly doses of placebo to match the administered dose of canakinumab s.c.
15990321|NCT02961192|Behavioral|Supportive social incentive|A family member or friend will be used as a support person in this study, to receive updates and support the participant in their progress.
15990322|NCT02961192|Behavioral|Competitive social incentive|Participants in this intervention will be competing against each other in the game.
15990323|NCT02961192|Behavioral|Collaborative social incentive|Participants in this intervention will be working with each other in the game.
15990324|NCT02961179|Behavioral|Increased dairy product|
15990325|NCT02961179|Behavioral|Dietary counselling|
15990326|NCT02961166|Drug|IgM enriched Immunoglobulins|Treatment for 3 days
15990327|NCT02961153|Other|death|
15990328|NCT02961140|Other|Cardiac Output Maximization|According to Frank-Starling law, the investigator will administer Voluven 6% 250 mL every 5 minute until stroke volume maximized (stabilized for 20 minutes), and maintain cardiac index and stroke volume variation during the whole operation.
15990329|NCT02961140|Other|Cardiac Output Normalization|The investigator will administer intravenous fluids to keep cardiac index (CI) ≥ 2.2, and maintain CI and stroke volume variation during the whole operation.
15990332|NCT02961114|Device|Centricyte 1000|Use of Centricyte 1000 closed system digestion, incubation/agitation, and centrifugation to acquire a concentrated pellet of AD-cSVF
15990333|NCT02961114|Biological|IV Sterile Normal Saline|Sterile Normal Saline deployment of AD-cSVF in suspension of 500cc in IV pathway
15990334|NCT02961101|Drug|Anti-PD-1 antibody|Anti-PD-1 antibody will be given at 1-3mg/kg on day8 by IV every three weeks
15990335|NCT02961101|Drug|Decitabine|Decitabine will be given at 10mg/d on day 1to 5 by IV every three weeks
15990336|NCT02961101|Drug|Chemotherapy|Chemotherapy be given depends on the cancer type and treatment regimen before enrollment.
15990337|NCT02961088|Other|Pasta as part of a low GI/GL diet|
15990338|NCT02961075|Other|local surface anesthesia|Airway anesthesia for Bronchoscopy
15990339|NCT02961075|Device|Laryngeal tube|
15990340|NCT02961062|Drug|SAF312|
15990341|NCT02961062|Drug|Placebo|
15990342|NCT02961049|Procedure|Gingival displacement|Gingival displacement with a gingival cord (#0, #00 or #000) with specific spatula.
15990343|NCT02961049|Procedure|Enamel and dentin etched|Enamel and dentin etched with 35% phosphoric acid for 30 and 15 seconds, respectively.
15990344|NCT02961049|Procedure|Selective enamel etched|Selective enamel etched with 35% phosphoric acid for 15 seconds.
15990345|NCT02961049|Procedure|Wash and dry|Wash and dry with absorbent paper.
15990346|NCT02961049|Device|Total-etch adhesive system|Two layers of pirmer/bond on enamel and dentin with a brush.
15990347|NCT02961049|Device|self-conditioning adhesive system|One layer of acid/pirmer on enamel and dentin with a brush following to one layer of bond with a brush.
15990348|NCT02961049|Procedure|Photoactivated|Photoactivated for 20 seconds
15990349|NCT02961036|Other|Group 1 information|Group 1 prize draw information for participants to win 100% of an Amazon gift card (or currency equivalent) in invitation letter.
15990350|NCT02961036|Other|Group 2 information|Group 2 prize draw information for participants to win 75% of an Amazon gift card (or currency equivalent) in invitation letter.
15990351|NCT02961036|Other|Group 3 information|Group 3 prize draw information for participants to win 50% of an Amazon gift card (or currency equivalent) in invitation letter.
15990352|NCT02961036|Other|Group 4 information|Group 4 prize draw information for participants to win 25% of an Amazon gift card (or currency equivalent) in invitation letter.
15990353|NCT02961036|Other|Group 5 no information|Group 5 no Information for participants to enter a draw to win an Amazon gift card (or currency equivalent) in invitation letter.
15990354|NCT02961036|Other|Group A Reminder|One survey reminder at 14 days
15990355|NCT02961036|Other|Group B Reminders|Two survey reminders one at 14 days and one at 28 days
15990356|NCT02961023|Other|Exercise therapy|"3-week residential phase and 12-week outpatient phase.
~Residential phase
~Exercise will be supervised by a physiotherapist and prescribed based on cardiopulmonary exercise testing.
~A monitored daily program of exercise involving bicycle ergometry, walking, breathing exercises, dumbbell exercises 5 days per week.
~1.5 to 2 hours of exercise will be performed daily, with rest intervals.
~At weekends, lower intensity, unsupervised exercise mirroring the outpatient phase
~Ongoing exercise prescription will be based on tolerability, progress and HR
~Outpatient phase
~A training manual will be compiled based on the subjects exercise performance during the residential program and tailored specifically to their needs
~Participants will be provided with a cycle ergometer, weights and a HR monitor
~Weekly telephone contact will be made by the study doctor or physiotherapist, with adjustments made to training prescription as necessary"
15990357|NCT02961010|Behavioral|Keeping Safe|A whole school Preventative Education programme
15990358|NCT02960997|Drug|Sirolimus, 2%|
15990359|NCT02960997|Drug|Vehicle|
15990360|NCT02960984|Other|Task Oriented rehabilitation and aerobic training|Participants in the experimental group will receive 1 hour treatment comprising 30' of aerobic training and 30' of task-oriented training focused on uppper limb rehabilitation for 3 times a week for 20 sessions.
15990361|NCT02960971|Procedure|Thoracic surgery for lung cancer|Lung cancer resection performed via Video-assisted thoracoscopic surgery (VATS) and/or thoracotomy, including lobectomy, bilobectomy, pneumonectomy, resection of the tracheobronchial bifurcation, wedge resection, sleeve resection and combinations hereof.
15990362|NCT02960945|Drug|CTP-543, 16 mg (2 x 8 mg tablet)|
15990363|NCT02960945|Drug|Jakafi 15Mg Tablet|
15990364|NCT02960932|Device|ultrasound scanner|Ultrasound scanner used to the SSI technical reproducibility.
15990365|NCT02960919|Drug|oral amoxicillin or parenteral ampicillin/ penicillin and gentamicin|
15990366|NCT02960919|Drug|parenteral ampicillin/ penicillin|
15990367|NCT02960919|Drug|gentamicin|
15990368|NCT02960906|Drug|Nivolumab|"For Arms 1A and 4A:
~Nivolumab alone administered IV over 60 minutes at 240 mg every 2 weeks until disease progression, unacceptable toxicity or other reasons specified in the protocol.
~For Arms 1B, 2B, 3B and 4B:
~Nivolumab administered IV over 60 minutes at 3 mg/kg combined with ipilimumab administered IV over 30 minutes at 1 mg/kg every 3 weeks for 4 doses followed by nivolumab administered IV over 60 minutes at 240 mg every 2 weeks until disease progression, unacceptable toxicity or other reasons specified in the protocol.
~Starting from the Cycle 7 possibility to switch from nivolumab 240 mg every 2 weeks to 480 mg every 4 weeks according to the Investigator's preference."
15990369|NCT02960906|Drug|Ipilimumab|"For Arms 1B, 2B, 3B and 4B:
~Ipilimumab administered IV over 30 minutes at 1 mg/kg every 3 weeks combined with Nivolumab administered IV over 60 minutes at 3 mg/kg for 4 doses until disease progression, unacceptable toxicity or other reasons specified in the protocol."
15990370|NCT02960906|Drug|Pazopanib|"For Arms 2C and 3C (TKI pazopanib or sunitinib):
~Pazopanib 800 mg orally QD until disease progression, unacceptable toxicity or other reasons specified in the protocol"
15990371|NCT02960906|Drug|Sunitinib|"For Arms 2C and 3C (TKI pazopanib or sunitinib):
~Sunitinib 50 mg orally QD until disease progression, unacceptable toxicity or other reasons specified in the protocol"
15990372|NCT02960893|Drug|Troriluzole|Randomization Phase: Neat (i.e., drug substance without excipients); loose filled capsule.
15990373|NCT02960893|Drug|Placebo|Drug: Placebo Randomization Phase: Matching placebo loose filled capsule.
15990374|NCT02960893|Drug|Troriluzole|Extension phase: Neat capsule or formulated capsule (i.e., drug substance with excipients).
15990375|NCT02960880|Drug|Rivaroxaban (Xarelto, BAY597939)|15mg, 20mg
15990379|NCT02960841|Other|Conventional treatment|
15990380|NCT02960828|Procedure|Subthreshold Laser Photocoagulation|Selective Subthreshold Laser Photocoagulation is applied to the periphery of high-risk macular drusen
15990381|NCT02960828|Drug|intravitreal Anti-VEGF injection|To prevent choroidal neovascularization, intravitreal Anti-VEGF injection is done on a 3 month interval up to 1 year.
15990382|NCT02960828|Device|Subthreshold Laser|
15990383|NCT02960815|Biological|Intanza|
15990384|NCT02960815|Biological|Mutagrip|
15990385|NCT02960815|Drug|Aldara|
15990386|NCT02960802|Procedure|kidney transplantation|
15990387|NCT02960789|Other|Formalized clinical assessment of hydration status|Undertake and record a standard formalized clinical hydration assessment
15990388|NCT02960789|Other|Take a measurement of body weight on calibrated scales|Standard body weight measurements conducted on calibrated scales
15990389|NCT02960789|Device|"RF wristband hydration status measurement"|"Take measurements with RF wristband radio-frequency non-invasive wrist-based hydration status assessment device"
15990390|NCT02960789|Other|Measure capillary refill time with manual stopwatch|A standard visual assessment of capillary refill time, aided by the use of a stopwatch
15990391|NCT02960789|Device|"CRT device hydration status measurement"|"Take measurements with CRT device for non-invasively quantitatively assessing Capillary Refill Time"
15990392|NCT02960776|Behavioral|Sleep Restriction (SR)|Participants will be asked to keep their habitual wake time constant but delay their bedtime to achieve a reduction of 1.5 hours in total sleep time. A delay in bedtimes was chosen rather than advancing wake-up time because it most closely reflects differences in sleep timing behavior between short and normal sleepers.
15990393|NCT02960763|Drug|Aripiprazole Augmentation|Augment current antidepressant treatment with aripiprazole (tablets). Start at 2 mg daily; increase every two weeks (i.e., to 5, 7, 10 mg) to a maximum of 15 mg daily based on symptom severity and side effects.
15990394|NCT02960763|Drug|Bupropion Augmentation|Augment current antidepressant treatment with bupropion once-daily extended release, starting at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects.
15990395|NCT02960763|Drug|Switch to bupropion|Taper from current antidepressant therapy. Start bupropion once-daily extended release at 150 mg daily; titrated after four weeks to 300 mg daily based on symptom severity and side effects.
15990396|NCT02960763|Drug|Lithium Augmentation|Augment current antidepressant treatment with lithium carbonate tablets starting at 300 mg daily, titrated per blood level to 0.4-0.6 meQ/L.
15990397|NCT02960763|Drug|Switch to nortriptyline|Taper from current antidepressant therapy. Start on nortriptyline tablets starting at 1 mg per kg of body weight daily, titrated per blood level to 80-120 ng/ml
15990398|NCT02960750|Behavioral|"A workplace sit less and move more web-based program for Spanish office employees"|W@WS encourages office employees to progressively 'sit less and move more' during workdays over 19 weeks. During the first 8 weeks (ramping phase), tips are provided every two weeks to break occupational sitting time through incidental movement during work tasks, introduce short walks (5-10 minutes) during morning/afternoon work breaks and/or commuting time, introduce longer walks at lunchtime and achieve at least 10,000 daily steps as well as increase walking intensity. During weeks 9 to 19, W@WS provides automated guidance with periodic emails encouraging behaviors achieved in the previous phase. Ecological support strategies such as logging daily step counts into a personal account and receiving visual feedback on the achievement of goals are also provided
15990399|NCT02960750|Behavioral|Active Comparison group|The Active Comparison group maintained habitual behavior. The A-CG was given a pedometer and a paper diary to register daily step counts and self-reported sitting time throughout the intervention.
15990400|NCT02960737|Device|Oral screen|The oral screen is used for 30 seconds, three times a day, before meals and implies new possibilities for training of the orofacial muscles.
15990401|NCT02960724|Other|68Ga-NOTA-AE105 PET/CT|One injection of 68Ga-NOTA-AE105 (app. 200 Mbq) followed by Positron Emission Tomography Scan.
15990402|NCT02960711|Drug|Metformin Hydrochloride 850 MG Oral Tablet [Glucophage]|
15990403|NCT02960711|Drug|Ludipress, mg stereate, micronized hydrated silica, talcum|Tablet
15990404|NCT02960698|Other|IRM and comportemental tasks|
15990405|NCT02960685|Procedure|Echocardiography|
15990408|NCT02960646|Drug|Cyclophosphamide|Given IV
15990409|NCT02960646|Biological|Filgrastim|Given SC
15990410|NCT02960646|Drug|Fludarabine Phosphate|Given IV
15990411|NCT02960646|Other|Laboratory Biomarker Analysis|Correlative studies
15990412|NCT02960646|Drug|Melphalan|Given IV
15990413|NCT02960646|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo CD45RA depleted peripheral blood stem cell transplantation
15990414|NCT02960646|Biological|Rituximab|Given IV
15990415|NCT02960646|Drug|Tacrolimus|Given IV or PO
15990416|NCT02960646|Radiation|Total-Body Irradiation|Undergo TBI
15990417|NCT02960633|Device|Corail with collar.|
15990418|NCT02960633|Device|Corail without collar.|
15990419|NCT02960620|Device|TheraSphere Treatment|TheraSphere® is delivered into the liver tumor through a catheter placed into the hepatic artery. The hepatic artery provides the main blood supply to the tumor in the liver, whereas the portal vein supplies blood to normal liver parenchyma. TheraSphere® is embolized within the tumor and exerts a local beta radiation radiotherapeutic effect with relatively limited concurrent injury to surrounding normal tissue.
15990420|NCT02960607|Drug|Icotinib|Icotinib (250mg tid) until disease progression or unacceptable toxicities occurred.
15990421|NCT02960594|Biological|INO-1400|
15990422|NCT02960594|Biological|INO-9012|
15990423|NCT02960594|Biological|INO-1401|
15990424|NCT02960581|Biological|PGT121 3mg/kg IV|3mg/kg administered by IV Infusion
15990425|NCT02960581|Biological|PGT121 10mg/kg IV|10mg/kg administered by IV infusion
15990426|NCT02960581|Biological|PGT121 30mg/kg IV|30mg/kg administered by IV infusion
15990427|NCT02960581|Biological|PGT121 3mg/kg SC|"3mg/kg administered by SC injection
~Placebo: None"
15991965|NCT02949895|Drug|Cisplatin|
15990428|NCT02960581|Biological|Placebo (0.9% Sodium Chloride Injection USP (Saline))|
15990430|NCT02960555|Biological|Isatuximab|Given IV
15990431|NCT02960555|Other|Laboratory Biomarker Analysis|Correlative studies
15990432|NCT02960542|Behavioral|HELP Prevent Cancer Intervention|This Behavioral: Lifestyle Weigh Loss Intervention involves a dietary weight-loss program and an increase in caloric expenditure through moderate physical activity. The primary treatment objectives for the weight-loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight-loss of .3 kg/week for a total weight loss of 5-7%. The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 minutes/week.
15990433|NCT02960529|Procedure|extra-peritoneal high ligation of hernia|
15990434|NCT02960529|Procedure|intraabdominal high ligation of hernia|
15990436|NCT02960503|Drug|Azithromycin|Study participants will be randomized to the treatment arm (azithromycin 500 mg three times a week for 6 months).
15990437|NCT02960503|Other|Placebo|Study participants will be randomized to the control arm (placebo three times a week for 6 months).
15990438|NCT02960490|Drug|E6011|subcutaneous administration
15990439|NCT02960490|Drug|Placebo|subcutaneous administration
15990440|NCT02960477|Other|Pain Neuroscience education|A PNE session covers the neurobiology, neurophysiology and processing of pain.
15990441|NCT02960477|Other|Biomedical Education|A biomedical session covers the normal course of shoulder pain, anatomy, physiology and biomechanics of the shoulder, the expected course of postoperative shoulder pain, and the importance of self-care.
15990442|NCT02960464|Device|Transcranial direct current stimulation|
15990443|NCT02960464|Device|Sham Transcranial direct current stimulation|
15990444|NCT02960451|Other|PRIME care|Specialist medication, cognitive behavior therapy, family-focused therapy
15990445|NCT02960451|Other|Usual care|Medication and psychotherapy as available form community providers
15990446|NCT02960438|Drug|E6011|subcutaneous administration
15990447|NCT02960438|Drug|Placebo|subcutaneous administration
15990448|NCT02960425|Dietary Supplement|Delivra TM Livsport preworkout cream|High versus low dose topical creatine
15990449|NCT02960425|Dietary Supplement|Placebo|Topical placebo
15990450|NCT02960412|Drug|furosemide|10mg lasix given intraoperatively
15990451|NCT02960412|Drug|Normal Saline|Normal saline given intraoperatively as placebo
15990452|NCT02960399|Biological|Zostavax®|Zostavax® immunization
15990453|NCT02960386|Other|Machine Learning Algorithm|The algorithm will help participants improve physical activity by sustaining long term engagement with their fitness tracker.
15990454|NCT02960373|Other|White Bread (Control)|A randomized multiple-crossover acute-feeding trial design. Each participant will act as their own control receiving the treatments in random order, each separated by a 1 day washout period.
15990455|NCT02960373|Other|Dried Fruit - Glycemic Index|A randomized multiple-crossover acute-feeding trial design. Each participant will act as their own control receiving the treatments in random order, each separated by a 1 day washout period.
15990456|NCT02960373|Other|Catalytic Fructose Dose Effect|A randomized multiple-crossover acute-feeding trial design. Each participant will act as their own control receiving the treatments in random order, each separated by a 1 day washout period.
15990457|NCT02960373|Other|High GI Displacement Effect|A randomized multiple-crossover acute-feeding trial design. Each participant will act as their own control receiving the treatments in random order, each separated by a 1 day washout period.
15990458|NCT02960347|Device|High-definition (HD) transcranial direct current stimulator, HD-tDCS with 4x1 HD adaptor|Non-invasive focal neuromodulation
15990459|NCT02960334|Device|MyDiagnostick|The MyDiagnostick is a compact hand-held device that registers and stores I-lead ECG strips. In one minute, t analyses the rhythm for the presence of AF. It distinguishes AF from normal cardiac rhythms by measuring RR-irregularity.
15990460|NCT02960308|Radiation|Computed Tomography Perfusion Imaging|Undergo WNCTP scan
15990461|NCT02960295|Device|1-Self-monitoring of blood glucose|"Self-monitoring of blood glucose 4 times daily: fasting and 1-hour after each meal. Results will be recorded and transmitted in real-time via a Bluetooth connection to a cellphone app installed on study enrollment. Intervention: At every office visit and at every telephone (virtual) visit the patient's physician will review glucose results and make adjustments in diet, activity, or medication to bring glucose into desired range."
15990462|NCT02960295|Device|2-Self-weighing|Self-weighing on electronic scale at least once a week. Results will be recorded and transmitted in real-time via a Bluetooth connection to a cellphone app installed on study enrollment. Consultation with the nutritionist will be obtained for women gaining in excess of or less than that indicated for her pre-pregnancy BMI, per Institute of Medicine (IOM) standards.
15990463|NCT02960295|Device|3-Self-checking of blood pressure|Self-checking of blood pressure at least weekly with sphygmomanometer. Results will be recorded and transmitted in real-time via a Bluetooth connection to a cellphone app installed on study enrollment. Patients with elevated blood pressure will be requested to come to Obstetrics Triage immediately for further assessment.
15990464|NCT02960295|Device|4-Checking fetal heart rate|Patient will record her fetus' heart rate with a Doppler device at least once weekly. The patient will immediately report to Labor and Delivery for any fetal heart rate below 100 beats per minute or greater than 160 beats per minute over a 10 minute observation period.Those reporting a fetal heart rate outside of the normal range will be requested to come to ObstetricTriage for further assessment.
15990465|NCT02960295|Procedure|5-Visits with caregivers|Telephone visits will alternate with in-office visits.Those failing to keep appointments will be contacted and reappointed at a mutually convenient time.
15990466|NCT02960282|Procedure|Biospecimen Collection|Undergo collection of fecal specimens
15990467|NCT02960282|Other|Laboratory Biomarker Analysis|Correlative studies
15990468|NCT02960269|Other|interprofessional back pain assessment|team assessment and education with urban physical therapist and rural nurse practitioner via telehealth
15990469|NCT02960256|Device|ekocardiogram test|ekocardiogram test
15990798|NCT02957929|Drug|Matching placebo control|
15990470|NCT02960243|Device|Deep Brain Stimulation|"DBS System Medtronic
~DBS programming settings will be set to maximally alleviate limb tremor, primary reason for referral
~These settings will be used to evaluate effects of voice tremor as well"
15990471|NCT02960230|Biological|K27M peptide|K27M peptide vaccine, combined with Tetanus Toxoid peptide, emulsified in montanide. Poly-ICLC will be given concurrently
15990472|NCT02960230|Drug|Nivolumab|anti-PD1 monoclonal antibody
15990473|NCT02960217|Drug|UX007|liquid for oral (PO) administration
15990474|NCT02960217|Drug|Placebo|liquid safflower oil for PO administration
15990475|NCT02960204|Drug|Emricasan|
15990476|NCT02960204|Drug|Placebo|
15990477|NCT02960191|Device|Magnetic resonance imaging (MRI)|
15990478|NCT02960178|Behavioral|Perturbation-based training|Over-ground practice of stepping and balance tasks in standing with perturbations applied by the trainer (pushes and pulls to the safety harness). One hour in duration with 60 perturbations targeted per hour.
15990479|NCT02960178|Behavioral|Conventional walking training|Over-ground practice of stepping and balance tasks in standing. One hour in duration.
15990480|NCT02960165|Behavioral|Virtual interface group|First practice on virtual interface in order to evaluate the improvement and its influence on real interface performance (second practice).
15990481|NCT02960165|Behavioral|Real interface group|First practice on real interface in order to evaluate the improvement and its influence on virtual interface performance (second practice).
15990482|NCT02960152|Other|diagnostic|full-mouth periodontal examination
15990483|NCT02960139|Device|Test- Treatment with Sylys Surgical Sealan|Standard closure of stapled anastomosis plus treatment with Sylys Surgical Sealant
15990484|NCT02960126|Drug|Aspirin|
15990485|NCT02960126|Drug|Clopidogrel|
15990486|NCT02960113|Drug|scopolamine patch|Group I (n=80): Will receive scopolamine patch placement on the skin behind the right ear 1 hour before initiation of the regional anesthesia for the duration of surgery. The time of the application of the patch will be recorded, and the time of the start of the surgery will be recorded. The last time point for evaluation of patient's nausea/vomiting will be when the patient arrives to the post anesthesia care unit. A member of the research team will remove the patch from the patient and properly dispose the patch upon arrival to the post anesthesia care unit.
15990487|NCT02960113|Device|acupressure point P6|Group II (n=80): Will receive acupressure point P6 stimulation. This is a stimulation of the chi channel at the master of the heart (MH8 position) at the small depression of the volar surface of the distal right forearm just above the crest of the wrist. The device will be put on the patients in the operating room prior to administration of the regional anesthesia and will be removed after the cesarean section is complete. The device will be removed from the patient in the operating room, before the patient is transported to the recovery room. Patients will receive continuous stimulation at a level that is comfortable for her prior to administration of the standardized regional anesthesia.
15990488|NCT02960100|Other|Informational Intervention|Receive standard HPV vaccine information (HPV VIS)
15990489|NCT02960100|Other|Media Intervention|Receive targeted HPV vaccine narrative-style video
15990490|NCT02960100|Other|Survey Administration|Ancillary studies
15990491|NCT02960087|Radiation|Low dose rate brachytherapy|I-125 to a total dose of 144 Gy
15990492|NCT02960087|Radiation|High dose rate brachytherapy|27 Gy in 2 fractions
15990493|NCT02960074|Biological|Fecal Microbiota Capsule|We will treat patients with oral encapsulated frozen FMT over 2 days.
15990494|NCT02960061|Drug|Neoadjuvant chemotherapy|Eligible patients receive 4 cycles of mDOF(docetaxel 50 mg/ m2 day 1 + oxaliplatin 85 mg/ m2 day 2 + fluorouracil 400 mg/ m2 bolus iv followed by 600 mg/ m2 22 hours chronic infusion, day 2/3 + leucovorin 200 mg/ m2, day2/3; repeated every 14 days ).
15990495|NCT02960061|Procedure|D2 radical resection|Laparotomy or laparoscopic surgery are chosen according to the preference of the surgeon. Either cases, a throughout peritoneal cavity exploration is required to comfirmed the tumor resectability and peritoneal metastasis. A curative D2 resection is performed if achievable.
15990496|NCT02960061|Drug|Hyperthermic intraperitoneal perfusion chemotherapy|Two cycle of hyperthermic intraperitoneal perfusion chemotherapy is administered to patients who have received neoadjuvant chemotherapy and D2 resection, dosage and the relative parameter setting is described above.
15990497|NCT02960061|Drug|Adjuvant chemotherapy|Adjuvant chemotherapy using SOX or XELOX regimen will be administered as routine within 4-6 weeks.
15990498|NCT02960048|Device|Stabilizing splint|"A 2-mm-thick, hard, clear sheet of resin will be adapted to the maxillary arch .
~Small amount of self-curing acrylic will be added to the anterior portion of the appliance as a stop for the lower incisor. The area of this stop is approximately 4 to 6 mm. The patient should be instructed to close in Centric relation . Self-curing acrylic will be added to the occluding surface of the appliance. All occluding areas, except the contact on the anterior stop .
~Excess acrylic surrounding the centric contacts is removed with a hard rubber wheel on a lathe. All areas, except labial to the mandibular canines, are flattened to the contact marks. This area will create the eccentric guidance."
15990499|NCT02960048|Device|Anterior repositioning splint|"A 2-mm-thick, hard, clear sheet of resin will be adapted to the maxillary arch .
~Small amount of self-curing acrylic will be added to the anterior portion of the appliance as a stop for the lower incisor. The area of this stop is approximately 4 to 6 mm. The patient is instructed to protrude the mandible slightly and to open and close the mouth In this position.
~Self-curing acrylic will be added to the occluding surface of the appliance. All occluding areas, except the contact on the anterior stop .
~Excess acrylic surrounding the centric contacts is removed with a hard rubber wheel on a lathe."
15990500|NCT02960035|Drug|50mg etanercept|Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injection, 50mg per week
15990501|NCT02960035|Drug|25mg etanercept|Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injection, 25mg per week
15990502|NCT02960035|Drug|placebo|
15991966|NCT02949895|Drug|Etoposide|
15990506|NCT02960009|Device|HD-tDCS|Different stimulation protocols will be applied to the primary motor cortex of stroke patients
15990507|NCT02959996|Drug|Liposomal bupivacaine|liposomal bupivacaine injection in the Pfannenstiel incision
15990508|NCT02959996|Drug|Placebo|placebo injection in the Pfannenstiel incision
15990509|NCT02959983|Drug|Eluxadoline|Eluxadoline 100 mg oral tablets BID with food.
15990510|NCT02959983|Drug|Placebo|Placebo matching eluxadoline oral tablets BID with food.
15990511|NCT02959970|Drug|dapsone gel|Dapsone (ACZONE) 7.5% gel topically once daily.
15990512|NCT02959957|Drug|Temocillin|Total antibiotic treatment 7-10 days, of which at least 72 hours (9 doses) initial temocillin administration. In case of bacteraemia at baseline the total antibiotic treatment can be extended up to 14 days.
15990513|NCT02959957|Drug|Cefotaxime|Total antibiotic treatment 7-10 days, of which at least 72 hours (9 doses) initial cefotaxime administration. In case of bacteraemia at baseline the total antibiotic treatment can be extended up to 14 days.
15990514|NCT02959944|Drug|ibrutinib|Ibrutinib capsules administered orally daily
15990515|NCT02959944|Drug|Placebo|Placebo capsules administered orally daily
15990516|NCT02959944|Drug|Prednisone|Prednisone administered daily
15990517|NCT02959931|Other|High Potassium Meal|Breakfast meal that provides ~2400 mg of dietary potassium. Meals are isocaloric.
15990518|NCT02959931|Other|Low Potassium Meal|Breakfast meal that provides ~540 mg of potassium. Meals are isocaloric.
15990519|NCT02959918|Drug|SEL-212|SEL-212
15990520|NCT02959918|Drug|SEL-037|SEL-037, biologic
15990521|NCT02959918|Drug|SVP-rapamycin (SEL-110)|
15990522|NCT02959905|Biological|TSA-CTL|On day 0,TSA-CTL will be infused intravenously on the Patient Care Unit over 20-30 minutes.
15990523|NCT02959905|Drug|Cyclophosphamide|Cyclophosphamide 500 mg/m2/day IV in 250 ml for one day.
15990524|NCT02959905|Drug|Fludarabine|Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 2 days.
15990525|NCT02959892|Drug|Amphetamine|Amphetamine tablets.
15990526|NCT02959892|Drug|TAK -041|TAK-041 oral suspension.
15990527|NCT02959892|Drug|[11C] (+)-4-propyl-(+)-4-propyl-9-hydroxynaphthoxazine (PHNO)|[11C]PHNO injection.
15990528|NCT02959879|Drug|FOLFOX neoadjuvant chemotherapy|4 cycles of FOLFOX neoadjuvant chemotherapy are administrated to patient
15990529|NCT02959879|Drug|FOLFIRINOX neoadjuvant chemotherapy|4 cycles of FOLFIRINOX neoadjuvant chemotherapy are administrated to patient
15990530|NCT02959879|Procedure|curative surgery for resectable pancreatic duct adenocarcinoma|curative surgery for resectable pancreatic duct adenocarcinoma
15990531|NCT02959879|Drug|Standard adjuvant chemotherapy|12 cycles of standard adjuvant chemotherapy are administrated
15990532|NCT02959879|Drug|adjuvant chemotherapy|8 cycles of standard adjuvant chemotherapy are administrated
15990533|NCT02959866|Other|online income tool|An online tool that uses information about the patient to develop a tailored list of financial benefits that they are eligible to apply for.
15990534|NCT02959853|Drug|Anastrazole|
15990535|NCT02959853|Behavioral|weight loss|
15990536|NCT02959840|Device|Acupressure Point P6 stimulator|This device stimulates the chi channel at the master of the heart (MH8 position) at the small depression of the volar surface of the distal right forearm just above the crest of the wrist. The device is placed on patients in the operating room prior to administration of the regional anesthesia and will be removed after the cesarean section is complete. The device is removed from the patient in the operating room, before the patient is transported to the recovery room. Patients receive continuous stimulation at a level that is comfortable for the patient prior to administration of the standardized regional anesthesia.
15990537|NCT02959840|Drug|Metoclopramide|10 mg Reglan IV immediately prior to administration of the standardized regional anesthesia.
15990538|NCT02959840|Drug|Ondansetron|8 mg of Zofran IV immediately prior to administration of the standardized regional anesthesia.
15990539|NCT02959827|Drug|Iodinated contrast agents|Use of iodine contrast agents and doses following the decision of the treating physician.
15990540|NCT02959814|Other|QFR (observational)|QFR assessment by Medis Suite, Medis medical imaging B.V., The Netherlands
15990541|NCT02959801|Procedure|Percutaneous mechanical thrombectomy|Aspirex catheters(Straub Medical AG, Wangs, Switzerland)
15990542|NCT02959788|Other|Heart rate variability|All patients have a 10-minute recording analyzed for indices of heart rate variability.
15990543|NCT02959775|Biological|60 µg dose hepatitis B vaccine|three-dose, 60 µg per dose
15990544|NCT02959775|Biological|20 µg dose hepatitis B vaccine|three-dose, 20 µg per dose
15990545|NCT02959762|Dietary Supplement|Placebo-Control|two placebo softgel capsules per day (for 8 weeks) containing no vitamin K2 (menaquinone-7)
15990546|NCT02959762|Dietary Supplement|Low-Dose Vitamin K2 (menaquinone-7; 45-mcg/d)|one 45-mcg vitamin K2 (menaquinone-7) softgel capsule per day and one placebo softgel per day (containing no menaquinone-7) for 8 weeks
15990547|NCT02959762|Dietary Supplement|High-Dose Vitamin K2 (menaquinone-7; 90 mcg/d)|two 45-mcg vitamin K2 (menaquinone-7) softgel capsules per day for 8 weeks
15990548|NCT02959749|Drug|Osimertinib|80 mg oral daily; until disease progression, intolerable toxicities, or patient death.
15990549|NCT02959749|Drug|docetaxel, bevacizumab|Docetaxel and bevacizumab are common used in third line therapy in non-small cell lung cancer if not used before. Docetaxel (75 mg/m2) intravenous infusion on day 1 and bevacizumab (7.5 mg/kg) on day 1 every 21days a cycle, until disease progression, intolerable toxicities, or patient death.
15990550|NCT02959736|Behavioral|MATADOC and CRS-R|Behavioural assessments for Disorders of Consciousness
15990551|NCT02959710|Drug|AC-1204 mixed in water|40 g AC-1204 (shaken in 240 mL of water) at Hour 0 on Day 1
15990552|NCT02959710|Drug|AC-1202 mixed in water|60 g AC-1202 (shaken in 240 mL of water) at Hour 0 on Day 1
15990553|NCT02959710|Drug|AC-1202 mixed in Ensure®|60 g AC-1202 (shaken in approximately 8 oz [237 mL of Ensure® Original] at Hour 0 on Day 1)
15990554|NCT02959697|Drug|Subcut. + Subconj. Xylocaine|Patient will receive the standard subcutaneous local anesthetic as well as an additional subconjunctival injection of local anesthetic (Xylocaine).
15990555|NCT02959697|Drug|Subcut. + Sham Subconj. Injection|Patient will receive the standard subcutaneous local anesthetic as well as a subconjunctival sham injection of Normal Saline.
15990556|NCT02959697|Procedure|Blepharoptosis Repair|Patients will undergo blepharoptosis repair using an anterior approach.
15990557|NCT02959671|Device|Lower Anterior EXD-952 Self-ligating Brackets|Placement of EXD-952 Self-ligating Brackets on mandibular incisors
15990558|NCT02959658|Drug|Dimethyl fumarate|
15990559|NCT02959658|Drug|Placebo|Manufactured to mimic Dimethyl Fumarate capsules
15990560|NCT02959632|Behavioral|Animal Assisted Therapy|Animal Assisted Therapy is the program where a pet, usually dog will visit and interact with the patients.
15990561|NCT02959619|Drug|Ensartinib|Oral ensartinib was given daily at escalating doses in a 28-day cycle
15990562|NCT02959606|Drug|Sarpogrelate SR 300mg|
15990563|NCT02959606|Drug|Clopidogrel|
15990564|NCT02959593|Device|VISIOR video goggles|View commercially available content through the VISIOR video goggles continuously for thirty minutes.
15990565|NCT02959580|Drug|Hydrocortisone Butyrate|topical use
15990566|NCT02959580|Procedure|extended excision|Lesion extended excision with or without a random breast dermo-glandular flap (BDGF).
15990567|NCT02959567|Device|Aqueduct 100 dilation|
15990568|NCT02959554|Drug|Nivolumab|240 mg i.v. on D1 of every cycle (Q2W) for 16 weeks. After 16 weeks 480 mg i.v. on D1 of every cycle (Q4W) until disease progress, intolerable toxicity, withdrawal of consent or end of study.
15990569|NCT02959554|Drug|Sunitinib|According to Standard of Care (SOC). Recommended dose is 50 mg p.o. once daily for 4 consecutive weeks followed by a 2-week rest period (schedule 4/2) to comprise a complete cycle of 6 weeks (until disease progress, intolerable toxicity, withdrawal of consent or end of study).
15990570|NCT02959554|Drug|Pazopanib|According to Standard of Care (SOC). Recommended dose is 800 mg p.o. daily continuously (until disease progress, intolerable toxicity, withdrawal of consent or end of study).
15990571|NCT02959541|Drug|Leucovorin|
15990572|NCT02959528|Other|Working memory training|n-back training program
15990573|NCT02959528|Other|perceptual training|visual-perceptual training program
15990574|NCT02959515|Procedure|Capnothorax|Insufflation of CO2 at a preset pressure of 10 cmH2O in the right pleural cavity.
15990575|NCT02959515|Procedure|Capnothorax and CPAP|"Insufflation of CO2 at a preset pressure of 10 cmH2O in the right pleural cavity.
~Continuous positive airway pressure of 10 cmH2O delivered by CF 800 Continuous flow CPAP, Drager."
15990576|NCT02959502|Other|Receive tDCS+CR|Over the course of 8 weeks, for 5 days a week, participants designated a 'Patient' will receive active tDCS &CR at-home. tDCS will be administered during the 2 hour CR sessions for 30 min/day. The tDCS montage will be bifrontal91 with 1 large anode placed over Fz and the cathode over Iz. The direct current will be 2 mA (current density = 0.57 A/m2). CR sessions will utilize didactic and computerized drill-based exercises which focus on practice and repetition of neurocognitive ability areas that are affected in depression such as attention, processing speed, executive function, verbal memory, and working memory. Performance feedback is given to reinforce progress and the exercises are designed to be enjoyable to complete, with titrated difficulty levels over time.
15990577|NCT02959502|Other|Facilitate tDCS + CR|Over the course of 8 weeks, for 5 days a week, participants designated a 'facilitator' will be trained to deliver tDCS &CR at-home. tDCS will be administered during the 2 hour CR sessions for 30 min/day. The tDCS montage will be bifrontal91 with 1 large anode placed over Fz and the cathode over Iz. The direct current will be 2 mA (current density = 0.57 A/m2). CR sessions will utilize didactic and computerized drill-based exercises which focus on practice and repetition of neurocognitive ability areas that are affected in depression such as attention, processing speed, executive function, verbal memory, and working memory.
15990578|NCT02959489|Behavioral|Alzheimer's Disease Risk Disclosure|Subjects will learn a numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.
15990579|NCT02959489|Behavioral|Amyloid Brain Imaging and Alzheimer's Disease Risk Disclosure|"Subjects will learn their own elevated or not elevated amyloid results and a numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type."
15990580|NCT02959476|Drug|Ropivacaine|Anesthetic
15990581|NCT02959476|Drug|Placebos|Inactive comparator
15990582|NCT02959463|Other|Laboratory Biomarker Analysis|Correlative studies
15990583|NCT02959463|Radiation|Palliative Radiation Therapy|Undergo palliative radiation therapy
15990584|NCT02959463|Biological|Pembrolizumab|Given IV
15990585|NCT02959463|Radiation|Radiation Therapy|Undergo hemithoracic radiation therapy
15990586|NCT02959450|Dietary Supplement|Modified consistency and volume diet|Modified consistency diet, with a certain viscosity and controlled volume, which was designed from recommendations based on the review of different studies. A Chef and a Nutritionist developed and determined the viscosity of the menus with a Brookfield Viscometer (model RV). All the menus were prepared and evaluated at the Food Technology Department of this Institute to achieve the viscosity required with a food thickener. The nectar consistency had a viscosity of 51 to 350 centiPoises (cP) and the pudding consistency menus with a higher viscosity at 1,750 cP. The patient and/or their caregivers in the intervention group must attend to a training workshop to explain how to use the food thickener.
15990587|NCT02959437|Drug|Azacitidine|Five doses of azacitidine will be administered by subcutaneous injection or intravenously (IV) over Days 1 to 7 in Cycles 1 through 6.
15990588|NCT02959437|Drug|Pembrolizumab|Pembrolizumab will be administered in a 30-minute IV infusion every 3 weeks on Day 1 of each 21-day cycle.
15990589|NCT02959437|Drug|Epacadostat|Epacadostat tablets will be administered orally twice daily.
15990590|NCT02959437|Drug|INCB057643|INCB057643 will be orally self- administered once daily beginning on Cycle 1 Day 1 and continuously thereafter in 21-day cycles.
15990591|NCT02959437|Drug|Pembrolizumab|Pembrolizumab will be administered in a 30-minute IV infusion every 3 weeks of each 21-day cycle starting on Cycle 2 Day 1.
15990592|NCT02959437|Drug|Epacadostat|Epacadostat tablets will be administered orally twice daily starting at Cycle 2 Day 1.
15990593|NCT02959437|Drug|INCB059872|INCB059872 will be orally self- administered once daily OR every other day beginning on Cycle 1 Day 1 and continuously thereafter in 21-day cycles.
15990594|NCT02959424|Other|Spanish Northwestern Esophageal Quality of Life questionnaire|
15990629|NCT02959125|Dietary Supplement|Multiple micronutrients|Vitamin A 5000 iu, vitamin D 400 iu, vitamin C 100 mg, vitamin B1 7.5 mg, vitamin B2 3 mg, vitamin B6 10 mg, vitamin B12 10 mcg, fluoride 1 mg, Fe fumarate 91 mg, niacinamide 20 mg, Ca pantothenate 7.5 mg, folic acid 400 mcg, Zn 5 mg, Ca lactate 250 mg, copper 0.1 mg, iodine 0.1 mg
15991451|NCT02953418|Device|Radiofrequency ablation|RFA
15990595|NCT02959411|Drug|Tolvaptan|Tolvaptan is a selective vasopressin receptor antagonist that inhibits activation of the V2 receptor and synthesis and insertion of the aquaporin2 channel into the apical membrane of the renal collecting duct. Tolvaptan inhibits the reabsorption of free water, inducing free water diuresis and increasing serum sodium levels without adversely influencing electrolyte levels or stimulating the sympathetic nervous system or renin-angiotensin system.
15990596|NCT02959411|Drug|Standard of care diuretic therapy|Usual standard of care diuretic therapy for patients hospitalized with acute decompensated heart failure
15990597|NCT02959398|Device|Standard mammography|Standard mammography
15990598|NCT02959398|Device|Standard mammography and tomosynthesis|Standard mammography and tomosynthesis
15990599|NCT02959385|Radiation|Definitive Radiochemotherapy|Radiotherapy,IMRT, 60Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day
15990600|NCT02959385|Procedure|Neoadjuvant Radiochemotherapy|Concurrent Radiochemotherapy: Radiotherapy,IMRT, 40Gy; Chemotherapy, Docetaxel （25mg/m2）+Cisplatin (25mg/m2) 1st/8th/15th/22nd day; Receive radical surgery 4 to 6 weeks later.
15990601|NCT02959372|Other|lung ultrasound|
15990602|NCT02959372|Other|placebo|lung ultrasound. The attending physician will not know the result
15990603|NCT02959359|Drug|Ledipasvir 90mg/Sofosbuvir 400 mg|A 12 week Harvoni (Ledipasvir 90mg/Sofosbuvir 400 mg ) plus ribavirin will be provided after confirmation of curative treatment.
15990604|NCT02959359|Drug|Ribavirin|A 12 week Harvoni (Ledipasvir 90mg/Sofosbuvir 400 mg ) plus ribavirin will be provided after confirmation of curative treatment.
15990605|NCT02959346|Procedure|Sham Acupuncture|"Procedure:
~Sham Acupuncture(ipisilateral side, 0.3cun, No needle sensation (de qi) was elicited) Sham acupuncture will be applied by inserting acupuncture needle into acupoints(1cm away from the true acupoint):upper limb: Waiguan TE5; lower limb: Zusanli ST36.
~All procedures were carried out to a depth of 0.5 cm with disposable needles measuring 0.16 mm in diameter (40-gauge) and 12.7 mm in length (Yu Kuang, Taipei, Taiwan).
~Acupuncture treatment will consist of one session per day and consecutive three days after thoracoscopic surgery."
15990606|NCT02959346|Procedure|Acupuncture|"Procedure:
~Acupuncture(ipisilateral side, the needling depth decided by whether patients feel De qi, neutral supplementation and draining) Acupuncture will be applied by inserting acupuncture needle into acupoints: Zhigou TE6, Shousanli LI10, Hegu LI4, Neiguan PC6, Houxi SI3; lower limb: Biguan ST31, Fushe SP13, Zulinqi GB41; axillary area(Remove Needles right away after De qi): Yuanye GB22, Jiquan HT1; local area(Remove Needles right away after De qi): ashi point close to the pain area.
~The other needles will be left for 20 minutes and then removed. All procedures were carried out with disposable needles measuring 0.25 mm in diameter (32-gauge) and 44 mm in length (Yu Kuang, Taipei, Taiwan).
~Acupuncture treatment will consist of one session per day and consecutive three days after thoracoscopic surgery."
15990607|NCT02959333|Biological|hAEC|hAEC: human amniotic epithelial cells
15990608|NCT02959320|Procedure|Hip Hemiarthroplasty|This single-institution, prospective, randomized clinical trial will be performed on consecutive elderly patients admitted for surgical treatment of displaced femoral neck fractures with hemiarthroplasty (HA).
15990609|NCT02959307|Device|Transcranial Light Therapy|Transcranial light therapy penetrates the skin and brain using light energy; this makes transcranial light therapy noninvasive. Transcranial light therapy may activate under-stimulated brain regions.
15990610|NCT02959307|Device|Sham Transcranial Light Therapy|The same device used for the actual transcranial light therapy is used as the sham device; The device, when set to sham, will mimic the actual transcranial light therapy; however, when set to sham the device does not emit skin and cranium penetrating light emitting diode light energy.
15990611|NCT02959294|Procedure|Microcannula Harvest Adipose|Use of Closed Syringe Microcannula Harvest Autologous Adipose-Derived Stem/Stromal Cells
15990612|NCT02959294|Device|Centricyte 1000|Use of Centricyte 1000 Closed System Digestion Autologous AD-tSVF to create AD-cSVF
15990613|NCT02959294|Procedure|Sterile Normal Saline IV deployment AD-cSVF|Sterile Normal Saline Suspension AD-cSVF in 500 cc IV use
15990614|NCT02959281|Other|Providing caring physicians with hemodynamic variables|NICAS electrodes are applied to the skin of the forearm bilaterally (similar to EKG electrodes). Conductors, attached to the electrodes, connect the patient with the measuring system.
15990615|NCT02959268|Device|Al-Sense|Liner for diagnosis of amniotic fluid leakage verified by standard clinical diagnostic tests
15990616|NCT02959255|Drug|Esomeprazole|dosage difference
15990617|NCT02959229|Drug|Lactoferrin|
15990618|NCT02959229|Drug|Placebo (for Lactoferrin)|placebo in form of distilled water
15990619|NCT02959216|Other|Aerobic Exercise|Participants will be given a prescription to exercise up to 90% of their threshold heart rate for symptom exacerbation. Heart rate threshold will be monitored weekly in order to increase exercise level accordingly.
15990620|NCT02959216|Other|Stretching Exercise|Participants will be given a prescription to complete a standardized stretching protocol.
15990621|NCT02959190|Drug|Galcanezumab|Administered SC
15990622|NCT02959177|Drug|Galcanezumab|Administered SC
15990623|NCT02959177|Drug|Placebo|Administered SC
15990624|NCT02959164|Drug|Decitabine|"Dose escalation starting at 0.1mg/kg, subcutaneously administered on twice weekly schedule for three weeks of a 28 day cycle.
~Dose Escalation Schedule Dose Level/Dose of Decitabine per cycle Level -2: 0.1 mg/kg SQ twice weekly for 1 week; Level -1: 0.1 mg/kg SQ twice weekly for 2 weeks; Level 1*: 0.1 mg/kg SQ twice weekly for 3 weeks; Level 2: 0.2 mg/kg SQ twice weekly for 3 weeks;
~*Starting Dose Level"
15990625|NCT02959164|Drug|Gemcitabine|"Fixed infusion rate of 900 mg/m2, IV over 90 min, on Days, 1, 8 and 15 of a 28-day cycle.
~Dose Escalation Schedule Dose Level/Dose of Decitabine per cycle Level -2: 0.1 mg/kg SQ twice weekly for 1 week; Level -1: 0.1 mg/kg SQ twice weekly for 2 weeks; Level 1*: 0.1 mg/kg SQ twice weekly for 3 weeks; Level 2: 0.2 mg/kg SQ twice weekly for 3 weeks;
~*Starting Dose Level"
15990626|NCT02959151|Drug|CAR-T cell|CAR-T cells are generated by T cells from the patients or a suitable donor transfected by CAR-lentivirus vectors. There are three options for CAR-targets: GPC3 for hepatocellular carcinoma;mesothelin for pancreatic cancer metastatic; CEA for colorectal cancer metastatic.
15990627|NCT02959138|Drug|Lanraplenib.|20 mg (2 X 10 mg) tablets administered orally in a fasted state on Day 1
15990628|NCT02959125|Other|NutFish Based Food Supplementation|Cookies contain 500 Calories and 15 gram protein make from nut and ocean fish
15990792|NCT02957929|Drug|APX001 single oral dose fasted|
15990630|NCT02959125|Behavioral|Health Education in Pregnancy Class|Health education on pregnancy, complication, and breastfeeding by research team members
15990631|NCT02959125|Other|Government Food Supplementation|Cookies contain 500 Calories and 5 gram protein make from flour and egg
15990632|NCT02959125|Dietary Supplement|Fe Supplementation|Ferrous Fumarate 60mg and folic acid 0.400 mg
15990633|NCT02959112|Drug|Epinephrine|
15990634|NCT02959112|Other|Sterile water|
15990635|NCT02959112|Drug|Indomethacin Rectal Suppository|
15990636|NCT02959073|Other|Symptom Recording|Subjects muss record their allergic symptoms after contact with their cats
15990637|NCT02959060|Drug|BMS-986177|Single dose of BMS-986177 and multiple doses of Rifampin
15990638|NCT02959060|Drug|Rifampin|Single dose of BMS-986177 and multiple doses of Rifampin
15990639|NCT02959047|Drug|Alirocumab|150mg SQ every 2 weeks
15990640|NCT02959047|Drug|Matching placebo|SQ every 2 weeks
15990641|NCT02959021|Behavioral|weight loss intervention - self directed|
15990642|NCT02959021|Behavioral|weight loss intervention - peer coach|
15990643|NCT02959008|Device|measure TOI and BP|Both groups measure TOI and BP.
15990644|NCT02958995|Other|No Intervention|
15990645|NCT02958982|Drug|RP3128|Participants will receive single oral dose of RP3128 in SAD, multiple dose in MAD AND POC
15990646|NCT02958982|Drug|Placebo|Participants will receive single oral dose of RP3128 in SAD, multiple dose in MAD AND POC
15990647|NCT02958969|Drug|Apixaban|apixaban 2.5 mg orally twice daily for primary prevention of VTE for a duration of 6 months
15990648|NCT02958956|Drug|Pioglitazone|Participants with diabetes who were members of the KPNC registry, and had received at least 2 prescriptions for pioglitazone within a 6-month period were followed up to 15.5 years (1997-2012) in this observational study 1.
15990649|NCT02958943|Behavioral|On-screen electronic alert|On-screen notification regarding the patient's increased risk of stroke in AF and the lack of an active order for anticoagulation. Providers may then 1) access a template of FDA-approved anticoagulation regimens for stroke prevention in AF, 2) follow a link to evidence based clinical practice guidelines, or 3) proceed onto order entry after providing an explanation for why anticoagulation was not prescribed.
15990650|NCT02958930|Device|MemorEM 1000|The MemorEM 1000 device is self-contained and has been designed for in-home daily electromagnetic treatment in the radiofrequency range, allowing for complete mobility and comfort in performing daily activities during treatment. The device has a custom control panel that is powered by a rechargeable battery. This control panel/battery box is worn on the upper arm and wired to specialized antennas in the head cap worn by the subject. The device provides global RF treatment to the entire forebrain, including deep brain areas. For each of the 60 days of in-home treatment, two one-hour treatment will be given (early morning and late afternoon). Each treatment will be administered by the patient's caregiver, who will position the device on the patient's head and monitor treatment.
15990651|NCT02958917|Drug|Pirfenidone|This is a single-center, randomized, double-blind, placebo-controlled, efficacy and safety study of pirfenidone in subjects with FHP. Approximately 40 subjects will be randomized in a 2:1 ratio to receive pirfenidone 2403 mg/d or placebo for 52 weeks.
15990652|NCT02958917|Other|Placebo controlled|This is a single-center, randomized, double-blind, placebo-controlled, efficacy and safety study of pirfenidone in subjects with FHP. Approximately 40 subjects will be randomized in a 2:1 ratio to receive pirfenidone 2403 mg/d or placebo for 52 weeks.
15990653|NCT02958904|Other|using questionnaires|using questionnaires International Index Erectile Function and Beck Depression Inventory.
15990654|NCT02958891|Other|Data collection|Collection epidemiological dental measures
15990655|NCT02958878|Drug|Tamsulosin|
15990656|NCT02958878|Drug|Placebo Oral Capsule|
15990661|NCT02958852|Drug|Letrozole|
15990662|NCT02958852|Drug|Letrozole and atorvastatin|
15990663|NCT02958852|Drug|Fulvestrant|Fulvestrant will be used as second line treatment upon progression on first line treatment with letrozole +/- atorvastatin.
15990664|NCT02958839|Procedure|Catheter ablation|Patients with persistent or paroxysmal atrial fibrillation will go through catheter ablation
15990665|NCT02958826|Other|Questionnaire|Anonymous questionnaire asking patients about their experiences with surgical lights, surgical smoke, and surgical sounds during their outpatient procedure.
15990666|NCT02958813|Behavioral|IMARA|Morning and afternoon sessions begin with an icebreaker and/or poem to enhance ethnic and gender pride. IMARA's goals and motto are presented to emphasize strong mother-daughter relationships, foster sisterhood, build group cohesion, and increase motivation. Ground rules are reviewed, and each woman and girl signs the IMARA pact to confirm her commitment to the program. At the end of day 1, mothers and daughters receive homework for the week. Woven throughout IMARA is the impact of alcohol and drug use on risk behavior, including condom use while high.
15990667|NCT02958813|Behavioral|FUEL|FUEL™ Health Promotion Control Group: mothers and daughters randomly assigned to FUEL™ will participate in separate 2-day workshops identical in length and intensity to IMARA. FUEL™ promotes healthy activities by encouraging good nutrition, exercise, and informed consumer behavior. Investigators will also insert the following sessions from Balance into FUEL: alcohol use, drug/marijuana use, nutrition, exercise, and violence to increase program length.
15990668|NCT02958800|Other|Intervention|"The intervention will be 12-weeks in duration consisting of four blocks resulting from a 1:1 randomization of two different three-week treatment courses of a patient's existing antipsychotic medication. For example, the intervention ABAB means that a participant would undergo three weeks of treatment A, followed by three weeks of treatment B, followed by three weeks of treatment A, and lastly three weeks of treatment B.
~Treatment A block is defined as a mutually agreed upon dose of a participant's antipsychotic medication that is different (i.e. lower) than their enrolment dose.
~Treatment B block is defined as a mutually agreed upon dose of a participant's antipsychotic medication that is different (i.e. lower) than their enrolment dose and the dose in Treatment A."
15990669|NCT02958787|Radiation|Radiation Therapy|Radiation Therapy Using MRI Based Treatment Planning
15990793|NCT02957929|Drug|APX001 single oral dose fed|
15990670|NCT02958774|Radiation|Hypofractionated Radiation Therapy|Chest/Breast 4005 centigray (cGy)/15 fractions/267 cGy daily Regional nodes 4005 cGy/15 fractions/267 cGy daily 1000 cGy boost to lumpectomy/scar/undissected nodes 200 cGy daily
15990671|NCT02958761|Biological|intraarticular injections of platelet lysate|
15990672|NCT02958761|Drug|hyaluronic acid|intraarticular hyaluronic acid (20 mg/2 mL; Hyalgan, Fidia, Abano Terme, Italy) injections at the same intervals
15990673|NCT02958748|Other|taking blood sample|
15990674|NCT02958735|Other|Exercise Challenge|Participants randomized to an exercise condition will perform treadmill exercise for 30 minutes. Participants will self-select a comfortable walking speed. The treadmill grade will be adjusted to elicit and maintain the target heart rate.
15990675|NCT02958722|Procedure|diagnostic hysteroscopy|Endoscopic procedure to visualize uterine cavity
15990676|NCT02958722|Drug|physiological solution|
15990677|NCT02958722|Drug|carbon dioxide|
15990681|NCT02958696|Drug|HTL0018318|Two single doses of active drug (low, mid or high dose either as aqueous solution or capsule) separated by a washout of at least 12 days.
15990682|NCT02958683|Other|Chest wall motion analysis|Assessment of chest wall motion using novel technologies including: optoelectronic plethysmography (OEP), structured light plethysmography (SLP), Microsoft Kinnect
15990683|NCT02958670|Other|18F-AV-1451 (Tau-PET tracer)|Single i.v. administration of 18F-AV-1451 (Tau-PET tracer) and consecutive Positron-Emission-Tomography-Scan
15990684|NCT02958657|Other|Exercise Training|Supervised exercise training program that includes two workouts per week for three months at a rehabilitation unit.
15990685|NCT02958644|Dietary Supplement|Synbiotics|12g / day synbiotics (fructo-oligosaccharide and probiotics) supplemented orally for 90 days
15990686|NCT02958644|Dietary Supplement|Placebo|12g / day placebo (polydextrose) supplemented orally for 90 days
15990687|NCT02958631|Drug|Fimasartan|
15990688|NCT02958631|Drug|Losartan|
15990689|NCT02958618|Procedure|"30 group"|A limited sphincterotomy (EST) was performed prior to the EPBD.The length of the sphincterotomy incision was limited to a third of the size of the papilla. A CRE balloon (diameter 10, 12, 15, 18) was chosen according to the diameter of bile duct. The balloon was then gradually filled with diluted contrast medium under endoscopic and fluoroscopic guidance to observe the disappearance of the waist. Once the waist disappeared, the balloon remained inflated for 30 seconds. The stones were then retrieved by a basket or retrieval balloon. An ENBD catheter (.) was routinely placed into the CBD after stone removal.
15990690|NCT02958618|Procedure|"60 group"|A limited sphincterotomy (EST) was performed prior to the EPBD.The length of the sphincterotomy incision was limited to a third of the size of the papilla. A CRE balloon (diameter 10, 12, 15, 18) was chosen according to the diameter of bile duct. The balloon was then gradually filled with diluted contrast medium under endoscopic and fluoroscopic guidance to observe the disappearance of the waist. Once the waist disappeared, the balloon remained inflated for 60 seconds. The stones were then retrieved by a basket or retrieval balloon. An ENBD catheter (.) was routinely placed into the CBD after stone removal.
15990691|NCT02958618|Procedure|"180 group"|A limited sphincterotomy (EST) was performed prior to the EPBD.The length of the sphincterotomy incision was limited to a third of the size of the papilla. A CRE balloon (diameter 10, 12, 15, 18 ) was chosen according to the diameter of bile duct. The balloon was then gradually filled with diluted contrast medium under endoscopic and fluoroscopic guidance to observe the disappearance of the waist. Once the waist disappeared, the balloon remained inflated for 180 seconds. The stones were then retrieved by a basket or retrieval balloon. An ENBD catheter (.) was routinely placed into the CBD after stone removal.
15990692|NCT02958605|Device|Smartphone apps|If already own a smartphone application dedicated to calculate medication dosage for children, the participant will be allowed to use his/her own application. Otherwise, the resident will be offered to chose among a list of applications paid by the research team (PediSafe, PediStat, Palm Pedi, Safedose, EZdrip peds). He/she will be instructed to practice with a few time at home before doing the simulations.
15990693|NCT02958605|Device|Handbook|Resuscitation handbook who provides drug dosages for each weight for children. For example, at the page of 15 kg, it is written that the dosage of epinephrin is 1.5 cc of 1: 10 000.
15990694|NCT02958592|Other|two-dimensional shear-wave elastography (SWE)|performa two-dimensional shear-wave elastography (SWE) for staging hepatic fibrosis in the background liver parenchyma in patients with liver tumors before hepatic resection
15990695|NCT02958579|Other|No intervention will be done. Participants are on standard care and the treatments will be recorded because of observational nature of this study.|
15990696|NCT02958566|Drug|Acetaminophen|
15990697|NCT02958566|Drug|Gabapentin|
15990698|NCT02958566|Drug|Orphenadrine|
15990699|NCT02958566|Drug|Lidocaine|
15990700|NCT02958566|Drug|Marcaine|
15990701|NCT02958566|Drug|Ketamine|
15990702|NCT02958566|Drug|Methadone|
15990703|NCT02958566|Drug|Tramadol|
15990704|NCT02958566|Drug|Ketorolac|
15990705|NCT02958566|Drug|Morphine Sulfate|
15990706|NCT02958566|Drug|Fentanyl|
15990707|NCT02958566|Drug|Dilaudid|
15990708|NCT02958566|Drug|Hydrocodone-Acetaminophen Tab 5-325 MG|
15990709|NCT02958566|Drug|Morphine Sulfate|PCA
15990710|NCT02958566|Drug|Fentanyl|PCA
15990711|NCT02958566|Drug|Dilaudid|PCA
15990712|NCT02958566|Drug|HYDROCODONE/ACETAMINOPHEN 5 Mg-325 Mg ORAL TABLET|Breakthrough
15990713|NCT02958553|Device|emPOWER Ankle|The device is 510k cleared and is intended to replace a missing foot and ankle. The emPOWER Ankle is to be used exclusively for fittings of lower-extremity amputations as prescribed by a healthcare professional.
15990714|NCT02958553|Device|Subject's own passive prosthesis|Devices will vary. Data gathered will form a baseline.
15990715|NCT02958540|Biological|SynGEM|Prime / boost vaccination in each group
15990716|NCT02958540|Other|placebo|prime /boost vaccination
15991452|NCT02953405|Drug|Clopidogrel|
15990717|NCT02958527|Drug|venlafaxine|The usual adult starting dosage for oral use is 37.5 mg of venlafaxine once daily, which is increased to 75 mg once daily after a meal from 1 week later. The dose may be adjusted within a range not exceeding 225 mg/day according to the patient's age and symptoms. However, the dose should be increased by 75 mg/day at intervals of not less than 1 week.
15990718|NCT02958514|Device|intense pulsed light|Intense pulse light (IPL) has been used in dermatology practices for several years as a treatment for rosacea and acne.IPL uses Xenon flashlamp to emit wavelengths of light from 400 to 1200nm. When placed on the light, a filter restricts the wavelength to the visible light range of *500nm.In 2007-2008, an IPL treatment technology-the Diamond Q4 by DermaMed Solutions-was specifically configured to our specifications with the goal of stimulating secretion of normal meibum via skin treatment effects on the meibomian glands. It was discovered that dry eye patients are better positioned for gland expression, as IPL seems to liquefy the abnormal viscous meibum and dilate the glands.
15990719|NCT02958514|Drug|Tobramycin and Dexamethasone Ophthalmic Ointment|
15990720|NCT02958501|Drug|Colecalciferol|Drug
15990721|NCT02958488|Device|High Flow Nasal Cannula|
15990722|NCT02958475|Behavioral|Social Support Group (Facebook)|The breastfeeding social support group on Facebook will be moderated to facilitate posting of shared experiences. Short videos, photographs, and written blurbs on related topics are posted on the Facebook page to reinforce the messaging and content of the texts.
15990723|NCT02958475|Behavioral|Breastfeeding messages|The Mother's Milk Messaging app gives participants access to text messages via push notification on the app, as well as access to videos and written material to facilitate knowledge acquisition and skills building. The text messages are targeted at specific theoretical constructs such as outcome expectations/attitudes, barrier self-efficacy, reinforcing a message using peripheral (expert) opinion, eliciting a sense of social currency or providing a cue-to-action.
15990724|NCT02958475|Behavioral|Injury Prevention Messages|The Mother's Milk Messaging app will provide participants in the control group with genetic injury prevention message.
15990725|NCT02958462|Other|follow up|
15990726|NCT02958449|Device|Test - Standard Closure with TissuGlu Surgical Adhesive|Patients randomized into the Test group, TissuGlu® will be applied to the chest wall after removal of the breast tissue using the custom applicator during a standard mastectomy procedure followed by normal wound closure (suturing technique) without drain placement.
15990727|NCT02958436|Drug|REGN3500|
15990728|NCT02958436|Drug|Placebo|
15990729|NCT02958423|Device|Transcranial DCS Healthy Volunteers|The DC stimulator manufactured by NeuroConn (Germany) will be used to deliver anodal direct current stimulation over the right primary motor cortex of healthy volunteers
15990730|NCT02958423|Device|Transspinal DCS Healthy Volunteers|The DC stimulator manufactured by NeuroConn (Germany) will be used to deliver anodal direct current stimulation over the D10 spinal process of healthy volunteers
15990731|NCT02958423|Device|Transcranial DCS CPP patients|The DC stimulator manufactured by NeuroConn (Germany) will be used to deliver anodal direct current stimulation over the right primary motor cortex of CPP patients
15990732|NCT02958423|Device|Transspinal DCS CPP patients|The DC stimulator manufactured by NeuroConn (Germany) will be used to deliver anodal direct current stimulation over the D10 spinal process of CPP patients
15990733|NCT02958410|Biological|Anti-CD30-CAR-transduced T cells|The first 3 enrolled patients will receive autologous-derived CD30-targeted CAR-T cells on day 1, 2 and 3 with respective 10%, 30% and 60% of the total expected dosage after receiving lymphodepleting chemotherapy. If the 3 patients don't display severe toxicity, the next patients enrolled will get infused in 2 days with respective 40% and 60% total dosage.
15990734|NCT02958397|Biological|Anti-CD33-CAR-transduced T cells|The first 3 enrolled patients will receive autologous-derived CD33-targeted CAR-T cells on day 1, 2 and 3 with respective 10%, 30% and 60% of the total expected dosage after receiving lymphodepleting chemotherapy. If the 3 patients don't display severe toxicity,the next patients enrolled will get infused in 2 days with respective 40% and 60% total dosage.
15990735|NCT02958384|Biological|Anti-LeY-CAR-transduced T cells|The first 3 enrolled patients will receive autologous-derived LeY-targeted CAR-T cells on day 1, 2 and 3 with respective 10%, 30% and 60% of the total expected dosage after receiving lymphodepleting chemotherapy. If the 3 patients don't display severe toxicity,the next patients enrolled will get infused in 2 days with respective 40% and 60% total dosage.
15990736|NCT02958371|Procedure|fMRI|
15990737|NCT02958371|Behavioral|fruit-flavored drink ingestion|
15990738|NCT02958358|Other|CT imaging, functional PET imaging|Physiology study using CT and functional PET imaging with 13NN and FDG as radiotracers; images obtained before and 3 months after treatment with ambrisentan.
15990739|NCT02958345|Biological|Zostavax|Vaccination with one dose of Zostavax per Zostavax package insert
15990740|NCT02958345|Other|Placebo|Injection of 0.65 mL of sterile normal saline
15990741|NCT02958332|Other|video game program|Participants will use the Wii console and the Wii balance board, to play different video games which imply shoulder movements. They will receive 5 individual sessions of 30 minutes.
15990742|NCT02958306|Biological|platelet rich plasma|PRP is a portion of the plasma fraction of autologous blood, having a platelet concentration above baseline values
15990743|NCT02958280|Behavioral|Fit&Sober App|Fit&Sober is a smartphone-based physical activity app that includes multilevel strategies for increasing physical activity for patients with AUDs in early recovery.
15990744|NCT02958280|Behavioral|Brief Advice|Participants randomized to the BA only condition will meet for a 30-minute discussion with a research staff member. In this session, participants will receive information about the public health guidelines for physical activity, the benefits of physical activity for physical and mental health, as well as sobriety, strategies for getting started as well as instruction on gradually increasing physical activity
15990745|NCT02958267|Biological|BMAC injection|60mL of bone marrow will be collected from a bone near the hip. Approximately 5-6mL of the bone marrow aspirate concentrate is then used for injection, under ultrasound guidance, into the target knee by the study physician.
15990746|NCT02958267|Biological|PRP injection|60mL of venous blood will be withdrawn from either arm. Approximately 4-5 ml of platelet-rich plasma will be introduced under ultrasound guidance to the subject's target knee by the study physician.
15990794|NCT02957929|Drug|APX001 multiple oral doses 1|
15990795|NCT02957929|Drug|APX001 multiple oral doses 2|
15990796|NCT02957929|Drug|APX001 multiple oral doses 3|
15990747|NCT02958267|Device|Gel-One® hyaluronate injection|Patients will receive a single injection of Gel-One® (3 ml syringe of Gel-One® - 1% solution [10 mg/mL], 30mg total hyaluronan) into the target knee. Injections will be performed by the study physician under real-time dynamic ultrasound guidance.
15990748|NCT02958241|Other|MRI|Supine and weight bearing MRI
15990749|NCT02958228|Behavioral|Positive Mental Imagery Training (PMIT)|
15990750|NCT02958228|Behavioral|Cognitive Control Training (CCT)|
15990751|NCT02958228|Other|Treatment as Usual|
15990752|NCT02958215|Drug|Phenylephrine|it will be given as a prophylaxis for prevention of hypotension after spinal anesthesia in pregnant patients undergoing cesarean section
15990753|NCT02958215|Other|Placebo|5 ml normal saline will be given before spinal anesthesia
15990754|NCT02958202|Drug|BMN 044 IV 6 mg/kg|
15990755|NCT02958202|Drug|BMN 044 IV 9 mg/kg|
15990756|NCT02958202|Drug|BMN 044 SC 6 mg/kg|
15990757|NCT02958189|Behavioral|Tweet4Wellness|A daily, behavior change theory-based intervention message is sent to a private, 25-person online Twitter-support group to prompt peer-to-peer discussion. Participants receive individual text messages to encourage group participation (e.g. 'thank you for participating' or 'please participate tomorrow'). Participants also receive weekly individual messages giving them daily step goals for the week based on their previous week's daily step average, recorded from Fitbit.
15990758|NCT02958189|Behavioral|Self-monitoring|A Fitbit is provided to the group which tracks participants' daily steps.
15990759|NCT02958176|Behavioral|HRV Biofeedback|At-home heart rate variability biofeedback using Elite HRV app and Polar H7 chest strap
15990760|NCT02958176|Behavioral|Autogenic Training|Autogenic training recording provided on a CD
15990761|NCT02958163|Procedure|Trans-arterial Chemo-Embolization|Trans-Arterial Chemo-Embolization will be performed with Doxorubicin-Eluting-Beads (DEB-TACE). It will be performed in each arm of treatment.
15990762|NCT02958163|Drug|Doxorubicin|Drug-eluting Bead for Trans Arterial Chemo-Embolization will be loaded with Doxorubicin.
15990763|NCT02958163|Radiation|Stereotactic Ablative Radiotherapy|"SABR schemes will be adapted according to the CP score and the vicinity of surrounding organs at risk. These are the different schemes proposed in this trial:
~48Gy = 3x16Gy BED 124.8Gy ( α/β=10) 50Gy = 5x10Gy BED 100Gy ( α/β=10) 48Gy = 6x8Gy BED 86.4Gy ( α/β=10) 40Gy = 5x8Gy BED 72Gy ( α/β=10)
~For patients with Child-Pugh (CP) A cirrhosis : the choice of the scheme will be left to each physician. The highest BED should be favored if dose constraints to the organs at risk are respected.
~For patients with CP B cirrhosis : only the latter scheme will be allowed: 40Gy = 5x8Gy."
15990764|NCT02958150|Drug|Dexmedetomidine|
15990765|NCT02958150|Procedure|Standard Clinical Practice|
15990766|NCT02958137|Procedure|Arthroscopic Resection Arthroplasty|Surgical removal of the arthritic joint(s) using a minimally invasive technique.
15990767|NCT02958111|Drug|Capecitabine|Patients will receive capecitabine (650 mg/m2 bid, p.o.，d1-21，q3wks; continued until disease progression, unacceptable toxicity, or over 1 year).
15990768|NCT02958085|Drug|NNC0174-0833|Doses of NNC0174-0833, dosed either once daily or once weekly
15990769|NCT02958085|Drug|Placebo|Dosed either once daily or once weekly
15990770|NCT02958072|Other|LeucoPatch|LeucoPatch is an fully autologous growth factor-containing dressing
15990771|NCT02958059|Biological|Pacetin® (cefoxitin)|1~2g of Cefoxitin (2nd generation cephalosporin) is administered to patients 30 minutes Before ERCP procedure. Cefoxitin is mixed with 10ml of normal saline. Patients and caregivers can not distinguish antibiotics and placebo by naked eye.
15990772|NCT02958059|Biological|Placebo|10ml of normal saline is injected to patients as placebo. Patients and caregivers can not distinguish antibiotics and placebo by naked eye.
15990773|NCT02958046|Drug|Lansoprazole/Domperidone|DUOLANS 30/30 mg SR tablet per oral, one tablet daily
15990774|NCT02958033|Radiation|Whole Breast irradiation Plus simultaneous tumor bed Boost|hypo-fractionated irradiation for experimental group and normal fractionated irradiation for comprator group
15990775|NCT02958007|Behavioral|Peer Education on Exercise for Recovery|A 24-week group-based peer coaching intervention delivered by a VA Peer Specialist, to promote participation in a supervised fitness training program and general physical activity
15990776|NCT02958007|Behavioral|Enhanced supervised fitness training|A 24-week intervention to promote participation in a supervised fitness training program and general physical activity, which includes individual support from non-peer staff
15990777|NCT02957994|Drug|Tenofovir alafenamide fumarate|Patients on TDF will be switched to TAF
15990778|NCT02957981|Behavioral|Web-based Counseling|The web-based genetic counseling and education intervention will include standard information typically provided in individual genetic counseling. the intervention will be individually tailored based upon key clinical and demographic characteristics of the participant.
15990779|NCT02957981|Behavioral|Standard Care|Standard care includes access to resource list for men from hereditary cancer families plus access to standard clinical genetic counseling
15990780|NCT02957968|Drug|Doxorubicin|60 mg/m2 once every 2 weeks for 4 cycles.
15990781|NCT02957968|Drug|Cyclophosphamide|cyclophosphamide 600 mg/m2 (AC) once every 2 weeks for 4 cycles.
15990782|NCT02957968|Drug|Paclitaxel|Paclitaxel 80 mg/m2 IV once weekly for 12 weeks.
15990783|NCT02957968|Drug|Carboplatin|carboplatin AUC 1.5 once weekly for 12 weeks.
15990784|NCT02957968|Drug|Decitabine|Given IV
15990785|NCT02957968|Drug|Pembrolizumab|Given IV
15990786|NCT02957955|Behavioral|High-Intensity Interval Training|Participants will complete supervised exercise sessions. Participants will attend on-site high-intensity interval training two times weekly for 12 weeks. Participants will complete six-minute walk test, cardiopulmonary exercise test, and six questionnaires: Short Form 36 Health Survey Questionnaire (SF-36), Minnesota Living with Heart Failure Questionnaire (MLHFQ), Beck Depression Inventory II (BDI-II), Beck Anxiety Inventory (BAI), Montreal Cognitive Assessment (MOCA), and Impact of Events Scale-Revised (IES-R) at baseline (week 1) and follow-up (after 12 weeks of intervention).
15990787|NCT02957942|Device|1Hz repetitive transcranial magnetic stimulation (rTMS)|1 session of low-frequency rTMS (1Hz, 1200 pulses, 20 minutes)
15990788|NCT02957929|Drug|APX001 single IV dose|
15990789|NCT02957929|Drug|APX001 single oral dose 1|
15990790|NCT02957929|Drug|APX001 single oral dose 2|
15990791|NCT02957929|Drug|APX001 single oral dose 3|
15990799|NCT02957903|Drug|Ropivacaine|All 20 study participants will receive both treatment A and B in form of a nerve block injection around the lateral femoral cutaneous nerve. Treatment A and B will be randomized to be given in either right or left lower extremity. If the participant is randomized to receive treatment A in the right lower extremity, treatment B will be given in the left lower extremity, and vice versa. Each participant will thus constitute as their own control.
15990800|NCT02957903|Drug|Isotonic Saline|All 20 study participants will receive both treatment A and B in form of a nerve block injection around the lateral femoral cutaneous nerve. Treatment A and B will be randomized to be given in either right or left lower extremity. If the participant is randomized to receive treatment A in the right lower extremity, treatment B will be given in the left lower extremity, and vice versa. Each participant will thus constitute as their own control.
15990801|NCT02957890|Biological|Inactivated influenza vaccine (NH formulation)|Round 1 (November): 0.5mL FluQuadri®, Sanofi Pasteur, containing 60μg antigen - 15μg for each influenza strain included - with strains recommended by the WHO for the northern hemisphere formulation
15990802|NCT02957890|Biological|Inactivated influenza vaccine (SH formulation)|Round 2 (May): 0.5mL Vaxigrip®, Sanofi Pasteur, containing 45μg antigen - 15μg for each influenza strain included - with strains recommended by the WHO for the southern hemisphere formulation
15990803|NCT02957890|Biological|Placebo|Round 2 (May): 0.5mL normal saline
15990804|NCT02957877|Drug|Nadroparin|A nadroparin infusion regimen (loading dose of 35 IU/kg, followed by 10 IU/kg per hour for 6 hours) is administered as anticoagulation during the 8-hour hemodialysis.
15990805|NCT02957877|Drug|Unfractionated heparin|The individualized unfractionated heparin infusion regimen currently employed by the recruited patients in their home dialysis treatment is administered as anticoagulation during the 8-hour hemodialysis.
15990806|NCT02957864|Drug|tenofovir alafenamide|
15990807|NCT02957864|Drug|abacavir|
15990808|NCT02957851|Drug|Medical Air|
15990809|NCT02957851|Drug|EMONO|
15990810|NCT02957838|Dietary Supplement|C18:0|Receives 24g of C18:0 in a low-fat banana milkshake.
15990811|NCT02957838|Dietary Supplement|mock|Low fat banana milkshake without C18:0 supplement.
15990812|NCT02957825|Device|Continuous wireless monitoring|Continuous wireless monitoring of vital signs
15990813|NCT02957812|Device|Custom-made Foot Orthotics (CFO)|Provides longitudinal arch support
15990814|NCT02957799|Behavioral|Accountable Condition|Mothers will receive home visits by government-funded CHW who will be trained under Philani as well as receive ongoing monitoring and supervision. CHW will monitor mother's health and linkage to care; CHW will refer all mothers to local clinics for HIV, blood sugar, and pregnancy testing. CHW will also have a mobile phone to record information at each visit. CHW will log their home visits each day, rate the content and skills addressed on the mobile phone, weigh children, and report outcome achievements (e.g., receiving the child grant, immunizations, breastfeeding, and retention/ adherence to HIV care). The CHW in this arm will receive data-informed supervision. CHW will be monitored weekly with review of contact logs, recorded outcomes, and random site visits by supervising in-service training on a monthly basis. The Accountable Condition will last for two years (until the child is 24 months old).
15990815|NCT02957799|Behavioral|Control Condition|Mothers will receive home visits by government-funded CHW who will be trained under Philani as well as receive supervision and monitoring consistent with local government practices. CHW will monitor mother's health and linkage to care. CHW will refer all mothers to local clinics for HIV, blood sugar, and pregnancy testing. The Control Condition will last for two years (until the child is 24 months old).
15990816|NCT02957786|Drug|Cytisine|Cytisine tablets
15990817|NCT02957786|Behavioral|Behavioural support|Withdrawal-orientated cessation support
15990818|NCT02957786|Drug|Varenicline|Varenicline tablets
15990819|NCT02957773|Behavioral|Qigong and art activities|Participants join a 90-minute session of integrated Qigong and art activity consisting of 30 minutes Qigong followed by 60 minutes art activity.
15990820|NCT02957773|Behavioral|Art activities|Participants join a 90-minute session that consists of 60-minute art activities followed by 30 minutes daily activities.
15990821|NCT02957773|Behavioral|Qigong|Participants join a 90-minute session that consists of 30-minutes Qigong exercise followed by 60 minutes daily activities (watching television, reading or sitting together).
15990822|NCT02957773|Behavioral|Daily activities|Participants do their daily activities routine for 90-minutes, such as watching television, reading and sitting together or participants can do free individual activities on their own.
15990823|NCT02957760|Drug|Hydroxycarbamid|20 mg/kg milligram(s)/kilogram per day during 6 month, oral administration (coated tablet).
15990824|NCT02957747|Behavioral|SHE|SHE is a computer-delivered intervention (Safety and Health Experiences Program; SHE) that will provide a screening and brief behavior intervention for women Veterans with any lifetime ST. More specifically, the intervention, SHE, will address interrelated health concerns for women Veterans with ST (i.e. alcohol misuse, IPV, and PTSD). SHE will provide individualized assessment, feedback, and referrals for women Veterans with any lifetime ST. SHE will take place within a primary care setting.
15990825|NCT02957734|Procedure|Rehabilitation of severely worn dentitions|Patients with severely worn dentition and functional problems are included in this study. Teeth are rehabilitated using indirect composite resin restorations in an increased vertical dimension of occlusion in order to optimize function and esthetics.
15990826|NCT02957721|Other|Usual Care|Patients will not be given the intervention but receive usual care for T2D.
15990827|NCT02957708|Other|mCIMT + SR|"Each participant wears a customized cotton sling on the unaffected arm for six hours everyday. Participant is engaged in fifteen unimanual tasks during the three-week training that provides them sufficient challenge and opportunities for repetition.
~SR is incorporated on the 1-hour structured practice by using video playback to help participants realize their own performance for better learning. Participant first performs a task with videotaping, then identifies steps with problems or difficulties by video playback of participant's performance. Secondly, participant is asked for possible solutions, prompting is given if needed. Lastly, participant performs the activity by adopting the suggested solutions with videotaping again to facilitate participant's evaluation of new performance."
15990933|NCT02956876|Drug|standard chemotherapy for colorectal cancer|standard chemotherapy for colorectal cancer
15990934|NCT02956876|Other|Nurse practitioner consultation|Nurse practitioner consultation will be done standard chemotherapy for colorectal cancer
15990828|NCT02957708|Other|Control|A combination of training on functional and remedial activities on unimanual tasks and bimanual tasks that based primarily on neurodevelopmental approach are provided. The training aims at increasing control, strength and functional use of their affected arm and hand, and improving bimanual coordination in performing daily activities. Each participant receives 1 to 2 hours of training per week at school. Home exercise including both unimanual and bimanual tasks is prescribed to them as well.
15990829|NCT02957695|Device|Placebo-Neurofeedback|The Intervention used for the control-group consists of a sham-neurofeedback, which is based on a previous eeg-recording and doesn't respond to the actual brain activity. The fact, that it is not a real neurofeedback, cannot be recognized by the patient nor the trainer because the eeg recording is not visible and the program reacts to muscle contractions (where feedback reactions would be expected) but not to brain activity.
15990830|NCT02957695|Device|Active-Neurofeedback|"The neurofeedback-method used in our study is called infra-low frequency neurofeedback Training, developed by S. and S. Othmer. NeuroAmpII® is the device and Cygnet® the corresponding Software used for this method, both are approved as an active medicinal device (CE-marked) in the European Union and in USA (www.eeginfo.com). The device and the Software are produced by the Company BEE Medic GmbH, Kirchberg, CH."
15990831|NCT02957682|Drug|Praluent (Alirocumab)|
15990832|NCT02957682|Drug|Placebo|
15990833|NCT02957669|Behavioral|Practice Self-Regulation|PS-R is an in-person, individual-level, clinic-based intervention implemented by mental health professionals trained in the intervention. It is intended to be implemented in ten structured, individual therapy sessions lasting approximately 50 minutes over the course of 18 weeks.
15990834|NCT02957669|Behavioral|Therapy Practice Group|Therapy Practice Group is the control condition aimed at providing the youth a safe space to work on meeting their mental health goals. It is intended to be at least ten sessions over the course of 18 weeks.
15990835|NCT02957656|Biological|H7N9 pLAIV|10^7.0 fluorescent focus units (FFU); delivered by an Accuspray device
15990836|NCT02957656|Biological|H7N9 pIIV|Administered by intramuscular injection in the deltoid.
15990837|NCT02957656|Biological|AS03 adjuvant|Mixed with H7N9 pIIV vaccine; administered by intramuscular injection in the deltoid
15990838|NCT02957643|Drug|Iron|oral treatment
15990839|NCT02957630|Drug|15 mg E4/3 mg DRSP|15 mg E4 combined with 3 mg DRSP administered in a 24/4-day regimen (i.e. 24 days of pink active tablets followed by 4 days of white placebo tablets). One tablet per day orally for 6 treatment cycles.
15990840|NCT02957630|Drug|30 mcg EE/150 mcg LNG|30 mcg EE combined with 150 mcg LNG administered in a 21/7-day regimen (i.e. 21 days of yellow active tablets followed by 7 days of white placebo tablets). One tablet per day orally for 6 treatment cycles.
15990841|NCT02957630|Drug|20 mcg EE/3 mg DRSP|20 mcg EE combined with 3 mg DRSP administered in a 24/4-day regimen (i.e. 24 days of pink active tablets followed by 4 days of white placebo tablets). One tablet per day orally for 6 treatment cycles.
15990842|NCT02957617|Drug|BIIB074|Participants will receive an initial dose regimen of 350mg orally twice daily (BID), which may be reduced to 200mg based on tolerability for up to 12 months.
15990843|NCT02957604|Drug|evolocumab|Pregnant women exposed to evolocumab. Evolocumab is not administered in this non-interventional study.
15990844|NCT02957591|Dietary Supplement|Vivomixx®|Streptococcus thermophilus Bifidobacterium breve Bifidobacterium longum Bifidobacterium infantis Lactobacillus acidophilus Lactobacillus plantarum Lactobacillus paracasei Lactobacillus delbrueckii subsp. bulgaricus
15990845|NCT02957591|Other|Placebo|Subjects in the placebo group will receive a placebo that contains starch but no bacteria. The appearance of the placebo will be indistinguishable in color, shape, size, packaging, smell, and taste from that of the probiotic supplement.
15990846|NCT02957578|Device|Solo TTD|Placement of tympanostomy tube with Solo TTD
15990847|NCT02957565|Behavioral|Baseline Questionnaires|Participant completes 5 questionnaires during an already-scheduled office visit. Questionnaires ask about symptoms, physical and emotional health, and trust in the medical profession. These questionnaires should take about 17 minutes to complete.
15990848|NCT02957565|Other|Videos|Participant watches 2 short videos that show actors playing doctor and patient roles, discussing different cancer-related symptom treatment options. Each video is about 4 minutes long and discusses the same content, but setting of each video is different.
15990849|NCT02957565|Behavioral|Assessment Questionnaires|"After viewing first video, participant completes assessment questionnaire to evaluate their opinion of the physicians behavior. These questionnaires should take about 5 minutes to complete.
~After viewing second video, participant completes the same 3 assessment questionnaires. Participant also completes 2 additional questionnaires asking which physician participant would prefer as a primary physician and the satisfaction with health information technology use in their care."
15990850|NCT02957552|Biological|Mesenchymal Stem Cells|Donor-specific, bone marrow derived mesenchymal stem (stromal) cells
15990851|NCT02957539|Behavioral|Financial rewards|Veterans in the financial reward arm receive all of the services of the usual care arm, plus rewards that are earned in two ways: an assured portion, and a random portion. For the assured reward, they will receive compensation at the end of each month (defined as a four week period) that they are at or below their target weight. For the random portion, each week that a participant is at or below their target weight, the patient is entered into a drawing to win additional compensation. Over the first eight weeks the patient has a 1-in-8 chance of winning. Over the 17-32 week period, Veterans in this group will receive token incentives for tracking and reporting their weekly weights regardless of whether it was on target. Each week that the patient enters their weight into the portal, s/he will have a 1-in-8 chance to earn the token incentive, such as a t-shirt or movie ticket. The participant will receive reminder text messages.
15990852|NCT02957539|Behavioral|Non-Financial rewards|Procedures for the non-financial rewards arm are identical to procedures for the financial reward arm, except that the Veteran will earn points rather than cash. Each weekly random drawing will be for 20 points. Veterans will choose non-financial rewards associated with the number of points they earn.
15990853|NCT02957526|Behavioral|Prompts to report symptoms via study app|Weekly prompts to report aromatase inhibitor use in the previous 7 days and treatment-related adverse symptoms via the web-enabled study app.
15990935|NCT02956876|Other|Medical practitioner consultation|Medical practitioner consultation will be done standard chemotherapy for colorectal cancer.
15991256|NCT02954692|Drug|sulfonylurea|"Pharmaceutical form: tablet
~Route of administration: oral"
15990854|NCT02957526|Behavioral|Clinical Alerts|: Reported symptoms may trigger an email alert to the participant's care team based on predetermined thresholds. Alerts based on certain response thresholds are generated to inform the patient's care team of any concerning responses or trends that emerge from the patient reported outcomes. These alerts will inform providers of particular patient-related adverse events or symptoms requiring an intervention prior to the point that emergent medical care is needed. Information in the alert emails will include the participant's Medical Reference Number (MRN), initials, date of birth, and details about the symptom(s) that generated the alert. Pod nurses instructed to respond to any clinical alerts (sent via email) as soon as possible following standard of care.
15990855|NCT02957513|Behavioral|Text Messaging (TM)|As specified in the arm description above
15990856|NCT02957513|Behavioral|Health Coaching (HC)|As specified in the arm description above
15990857|NCT02957513|Behavioral|Enhanced Usual Care (EC)|As specified in the arm description above
15990858|NCT02957500|Device|Mediclore® (adhesion barrier)|
15990859|NCT02957487|Device|Denture supported by 3 dental implants|Metal-reinforced denture without palatal coverage incorporating nylon rings retained by friction to Locator abutments fitted on top of dental implants
15990860|NCT02957474|Drug|GED-0301|
15990861|NCT02957474|Drug|Omeprazole|
15990862|NCT02957461|Device|BrainScope Ahead 200iD|The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT3), Electrophysiological Function; Neurocognitive Performance Assessment and Ocular Motor assessment. BrainScope Ahead 200iD device will be used to perform EEG.
15990863|NCT02957448|Drug|BMS 986141|Two single doses BMS 986141 (days 1 and 13) and single daily doses Rifampin (days 7-22)
15990864|NCT02957448|Drug|Rifampin|Two single doses BMS 986141 (days 1 and 13) and single daily doses Rifampin (days 7-22)
15990865|NCT02957435|Drug|eplerenone|(Single arm) Sequence 1: one eplerenone coated tablet 25 mg in fasting (period 1), one eplerenone coated tablet 50 mg in fasting (period 2) and two eplerenone coated tablets 50 mg (100 mg of eplerenone) in fasting (period 3)
15990866|NCT02957422|Dietary Supplement|1% Milk|1.5 gallons of 1% milk will be delivered to the participant's home weekly. Participants will be asked to drink 3 cups per day for 3 months.
15990867|NCT02957422|Dietary Supplement|Control|Participants will continue on their regular low dairy diet of ≤1.5 dairy serving/day.
15990868|NCT02957409|Drug|sacubitril/valsartan|This study is designed as an observational, naturalistic, multicenter study in patients being treated with sacubitril/valsartan as per the Canadian product label. Treatment initiation with sacubitril/valsartan must be within the last 3 months. Sacubitril/valsartan will be used as commercially available supplies which are available as Film coated tablets in 3 dosage: 1) 24 mg sacubitril / 26 mg valsartan, 2) 49 mg sacubitril / 51 mg valsartan and 3) 97 mg sacubitril / 103 mg valsartan.
15990869|NCT02957396|Drug|Finerenone (BAY94-8862): 20 mg intact tablet|20 mg intact finerenone immediate-release tablet; single dose in the fasting condition
15990870|NCT02957396|Drug|Finerenone (BAY94-8862): 20 mg crushed and resuspended tablet|20 mg crushed and resuspended finerenone immediate-release tablet; single dose in the fasting condition
15990871|NCT02957396|Drug|Finerenone (BAY94-8862): 20 mg suspension|20 mg finerenone suspension; single dose in the fasting condition or in the fed condition
15990872|NCT02957383|Other|Wavelength|wavelength at two levels: short (SWL)-485 nm (13500k) and long (LWL)-620 nm (4250k)
15990873|NCT02957383|Other|Intensity|Luminance at two levels: low - 80 lux (35mw/cm2) and high - 350 lux (160mw/cm2
15990874|NCT02957331|Drug|Propranolol|
15990875|NCT02957318|Dietary Supplement|FiberBind|Potato pulp consisting of 68% fiber (5.5 soluble, 76.7% insoluble and 17.8% resistant starch), 9.7% water, 0.3% fat, 7.2% protein and 14% carbohydrates (starch).
15990876|NCT02957318|Dietary Supplement|RG-I fiber|Soluble fiber extracted from potato pulp consisting of 95% fiber and 5% water.
15990877|NCT02957318|Dietary Supplement|Placebo|Low-fiber control
15990878|NCT02957305|Drug|Misoprostol 400mcg Tab|400µg of misoprostol (2 tablets)
15990879|NCT02957305|Drug|Misoprostol 200mcg Tab|200µg of misoprostol (1 tablet)
15990882|NCT02957279|Drug|Antibiotics|In the sepsis group, antibiotics were used when needed.
15990883|NCT02957266|Radiation|Volumetric Arc Radiotherapy|Volumetric Arc Radiotherapy
15990884|NCT02957266|Radiation|Interstitial brachytherapy|Interstitial High Dose Rate Brachytherapy
15990885|NCT02957266|Drug|Cisplatin|Weekly Cisplatin
15990886|NCT02957266|Drug|Gemcitabine|Weekly Gemcitabine
15990887|NCT02957266|Genetic|PIK3CA|PIK3CA mutations rate
15990888|NCT02957266|Genetic|KRAS|KRAS mutations rate
15990889|NCT02957266|Genetic|BRAF|BRAF mutations rate
15990890|NCT02957266|Genetic|RRM1|RRM1 mutations rate
15990891|NCT02957253|Other|risk factors|monitoring risk factors due to deterioration of the liver disease
15990892|NCT02957253|Other|self-care|information and motivation to adherence to self-care instructions and medical treatment
15990893|NCT02957253|Other|nutrition|nutritional assessment and activities to prevent malnutrition
15990894|NCT02957253|Other|lifestyle|motivation of lifestyle changes essential for disease progress and
15990895|NCT02957253|Other|psychosocial needs|psychosocial care.
15990896|NCT02957253|Other|Nurse-led clinic|compensated disease once yearly, decompensated disease twice a month to every third month
15990928|NCT02956941|Behavioral|BCC on Essential Nutrition and Hygiene Actions (ENHAs)|The behavioral change communication (BCC) on micronutrient intake messages will be implemented based on Essential Nutrition and Hygiene Actions (ENHAs) on micronutrient deficiencies prevention and control. BCC intervention training workshop will be given to science teachers by principal investigator/ senior health professional in local language. Interventions will be delivered to students by their science teachers under the supervision of principal investigator/ school director for the consecutive three times.
15990929|NCT02956915|Procedure|Transfemoral Transcatheter aortic valve implantation|Transcatheter aortic valve implantation (TAVI): The SAPIEN-3 prosthese are implanted without open heart surgery. The valve delivery system is inserted in the body via the femoral artery.
15990930|NCT02956902|Other|Clinician supported smartphone application intervention|
15990897|NCT02957240|Behavioral|Standard Care|"This group will partake in 4 clinic-based intervention sessions (one 1-hr. and 3 subsequent 30-minute sessions) where the focus will be on home program competency/advancement. Session 1 will occur within 1 week of cast treatment, session 2 in week 2, session 3 in week 4, and session 4 in week 5.
~Home program (3x daily, 15 minutes) to include 10 repetitions of active thumb opposition, active thumb radial abduction, intrinsic minus active stretches, flat fist and composite, finger extension, Elbow flexion and extension, Shoulder scapular rolls, and glenohumeral circumduction.
~Edema will be addressed through strict elevation when at rest and every 10 minutes on the hour. When resting in a seated or supine position, clients will be instructed to use pillows to accomplish elevation and to keep elbows in an extended position. Instructions for elevation will be provided immediately following orthopaedic intervention. Strict elevation will be recommended for the first 72 hours of the injury."
15990898|NCT02957240|Behavioral|Motor Representation Techniques|"Those in this group will receive 4 clinic-based intervention session (one 1-hr. and three subsequent 30-minute sessions) where the focus will be on home program competency and advancement. Session 1 will occur within 1 week of cast treatment, session 2 in week 2, session 3 in week 4, and session 4 in week 5.
~Home Program will be performed 3x daily for 15 minutes. A Motor Representation Technique (i.e., modified GMI) protocol described by Lagueux et al. will be employed. As originally designed the program was broken into three stages 1) Laterality, 2) Explicit Motor Imagery, 3) Mirror therapy with unaffected hand only and 4) Mirror Therapy with bilateral hands. For the purpose of this study, and given the restraint offered by cast immobilization, the 4th phase will not be used. Each phase will require 1-2 weeks and will be progressed at the discretion of the hand therapist interventionist."
15990899|NCT02957227|Device|No intervention is part of this study but patients use an EEG device during observational data collection.|
15990900|NCT02957214|Behavioral|Pain education|
15990901|NCT02957201|Other|Blood samples|Blood samples at baseline and 3 timepoints for EPC analysis
15990902|NCT02957188|Other|13C eicosapentaenoic acid and 13C arachidonic acid|Each participant orally consumed a single oral dose of 35 mg of 13C-EPA, and after the wash-out, a 50 mg dose of 13C-AA.
15990903|NCT02957175|Other|Immunophenotyping|Multiplex assays for screening pro- and anti-inflammatory markers and RNA will be analysed using a next generation sequencing approach
15990904|NCT02957162|Drug|Atorvastatin|
15990905|NCT02957162|Other|Blood samples|3-5 mls of blood is taken at baseline and 3 subsequent timepoints and processed for Endothelial Progenitor Count (EPC).
15990906|NCT02957149|Other|Autologous Platelet-Rich Plasma|Platelets that are collected from the subject during the radical prostatectomy, for prostate cancer. The platelets are concentrated in a device to 1,000,000 platelets/mL and applied topically once to the neurovascular bundle during the surgery.
15990907|NCT02957149|Device|Angel Concentrated Platelet Rich Plasma System|
15990908|NCT02957136|Device|Rapid respiratory pathogen nucleic acid amplification test|Patients randomized to the rapid respiratory pathogen nucleic acid amplification test (Film Array Respiratory Panel, BioFire Diagnostics), will receive usual physician-directed care plus results from a rapid diagnostic test for 20 common respiratory pathogens. Patients will have a nasopharyngeal swab sample collected and tested during the ED episode of care with results reported in the electronic medical record (EMR) within two hours of sample collection. ED physicians will receive education regarding the rapid respiratory pathogen test prior to commencing the study. During the study, ED physicians will be free to review and interpret the respiratory pathogen test results and make treatment decisions based on their individual clinical judgment without involvement of study personnel.
15990909|NCT02957123|Drug|Intranasal auto-M2-BFs|Delivery is performed with the aerosol inhaler device (nebulizer), 2.0 mL once a day up to 30 days.
15990910|NCT02957110|Behavioral|Laughter Frequency|Relationships between laughter frequency, momentary mood state, and pain will be observed.
15990911|NCT02957097|Drug|Gabapentin|Medication used for management of neuropathic pain conditions
15990912|NCT02957097|Drug|Placebo|Placebo medication. It looks exactly same as the Gabapentin medication in same size, shape, and color.
15990913|NCT02957058|Procedure|SCAR technique|Thermal ablation of the EMR margin using ERBE Soft Coagulation (Effect 4, 80 watts) and the operator choice of endoscopic resection snare
15990914|NCT02957045|Procedure|Cough pressure measurement|
15990915|NCT02957045|Device|Pcough|
15990916|NCT02957032|Drug|F16IL2|"All patients first receive an initial run-in dose of 30 Mio IU of F16IL2 on day 1 and escalating doses of F16IL2 on day 1, 8, 15 and 22.
~Treatment will be repeated every 28 days for up to three cycles."
15990917|NCT02957032|Drug|cytarabine|Patients will be treated with cytarabine (5 mg twice daily s.c. for 10 days). Treatment will be repeated every 28 days for up to three cycles.
15990918|NCT02957019|Drug|L19-IL2 - Ph I|Patients will receive increasing doses of L19-IL2 (0.32, 0.43, 0.57 and 0.76 Mio IU/kg of IL-2 equivalents per administration) during Phase I study
15990919|NCT02957019|Drug|L19-IL2 at RD - Ph II|Patients will receive L19-IL2 at the RD defined during the Phase I part of the study
15990920|NCT02957019|Drug|Rituximab|Patients will receive a fixed dose of Rituximab (375 mg/m2) per administration during Phase I and Phase II of the study
15990921|NCT02957006|Device|Loop Recorder|Observation of Loop Recorder implanted for clinical reasons
15990922|NCT02956993|Drug|vonapanitase|
15990923|NCT02956993|Drug|Placebo|
15990924|NCT02956980|Biological|Blood Plasmacytoid dendritic cells (pDCs) absolute number|Two 7 ml tubes will be necessary to perform the functional assays as well as the quantification of blood pDCs absolute number. Functional assays will be performed on isolated PBMC by Ficoll procedure. Quantification of blood pDCs absolute number will be performed on whole blood. After written parental consent, blood sample will be performed on children participating to the study.
15990925|NCT02956967|Other|Overall satisfaction questionnaires of home use of Nivestim|
15990926|NCT02956954|Drug|Enzyme replacement therapy (Agalsidase alpha (Replagal®))|Patient treated with Enzyme replacement therapy as usual (Agalsidase alpha (Replagal®)). The treatment is prescribed in routine and not specially for the protocol
15990927|NCT02956954|Procedure|Magnetic Resonance Imaging|Magnetic Resonance Imaging will be assessed every 6 months during 2 years
15990931|NCT02956889|Drug|Vismodegib|Patients will receive a continuous once-daily oral dosing of Vismodegib at a dosage of 150 mg .
15990932|NCT02956889|Radiation|Radiotherapy|Radiotherapy (RT) will be administered with a total dose of 50 Gy/2.5 Gy per fraction over 4 weeks.
15990936|NCT02956863|Procedure|Osteopathic manipulative treatment|Osteopathic manipulative treatment delivered on pragmatic way.
15990937|NCT02956863|Procedure|Exercises|Exercise for stretching and strength for neck muscles
15990938|NCT02956850|Other|Placebo|Placebo matching to RO7020531 will be administered as per schedule specified in the respective arm.
15990939|NCT02956850|Drug|RO7020531|RO7020531 will be administered as per schedule specified in the respective arm.
15990940|NCT02956837|Biological|RSV Vaccine (GSK3003891A) formulation 1|Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.
15990941|NCT02956837|Biological|RSV Vaccine (GSK3003891A) formulation 2|Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.
15990942|NCT02956837|Biological|RSV Vaccine (GSK3003891A) formulation 3|Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.
15990943|NCT02956837|Drug|Placebo (Formulation buffer S9b)|A single dose of placebo is administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.
15990944|NCT02956824|Other|Standard care|Current care
15990945|NCT02956811|Drug|Dapagliflozin|SGLT2 inhibitor
15990946|NCT02956811|Drug|Placebo|Matching Placebo
15990947|NCT02956798|Radiation|Stereotactic ablative body radiation (SABR)|SAbR treatment regimens including ≥25Gy x1 fraction, ≥12Gy x 3 fractions, or ≥8Gy x 5 fractions.
15990948|NCT02956785|Drug|10 mg Dinoprostone; CTS, UK|
15990949|NCT02956785|Drug|3 mg Dinoprostone vaginal tablet; Pfizer, UK|
15990950|NCT02956785|Drug|Aquacryl hydrogel rod; HPSRx Enterprises, USA|
15990951|NCT02956772|Drug|TACE|After the puncture of femoral artery via Seldinger method, a catheter was inserted and digital celiac axis or hepatic arteriography performed. Then a microcatheter was used to infuse chemotherapeutic agent (30 to 60 mg of pirarubicin) mixed with 5 to 20 mL of Lipiodol Ultra-Fluid. Embosphere microspheres (size of 100 to 300 um) were inserted for embolization.
15990952|NCT02956772|Drug|Arsenic trioxide|Arsenic trioxide 10 mg is put into 500 ml saline solution and then administrated by continuous intravenous drip for 5 hours during a treatment day.
15990953|NCT02956759|Procedure|Pan-retinal photocoagulation laser treatment|PRP initially consists of 1200 - 1600 burns given over 2-3 sessions and separated by2-3weeks by 532-argon laser machine.
15990954|NCT02956746|Biological|SYN023|The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
15990955|NCT02956746|Biological|Imovax|Subjects will receive SYN023 or HyperRAB ST (human rabies immune globulin) and 5 doses of Imovax rabies vaccine
15990956|NCT02956746|Biological|RabAvert|Subjects will receive SYN023 or HyperRAB ST (human rabies immune globulin) and 5 doses of RabAvert rabies vaccine
15990957|NCT02956746|Biological|HyperRAB ST (human rabies immune globulin)|The effects of SYN023 on immunogenicity of rabies vaccines Imovax and RabAvert will be compared to the effect of human rabies immune globulin.
15990958|NCT02956733|Procedure|dermotaxis|In dermotaxis (Singhs skin traction) method two parallel kirschner wires (1.5mm) will be passed through the dermis on either side of the wound margins and interconnected by compression device consisting of threaded rod having two blocks and compression knob. Gradual compression will be applied daily at the rate of 1 turn/12hours on both sides of the wound.
15990959|NCT02956733|Procedure|loop suture technique|The loop suture technique involves using corrugated drains and Ethilon no.1. It is an extension of the purse string suture technique where a surgical suture is passed as a running stitch in and out along the edge of a wound in such a way that when the ends of the suture are drawn tight the wound is closed. Two corrugated drains (1 & 2) will be anchored to the skin adjacent to the fasciotomy incision using Ethilon no.1. Then the sutures will be passed from one edge of the wound through the skin and corrugated drain to the other in an alternating fashion.
15990960|NCT02956720|Device|UltraShape Power|non-invasive body contouring procedure
15990961|NCT02956707|Other|No pre-operative steroids|Due to new information provide from previous studies at our center the investigator instituted a clinical practice change remove steroid administration in the pre-operative period for all neonates undergoing surgery with cardiopulmonary bypass. This study is to evaluate this change.
15990962|NCT02956694|Behavioral|Professional e-learning program on shared decision making|Clinicians will have access to a, e-learning program on shared decision making (e-TUDE) during one month. They will also receive five Decision Boxes (DB) dealing with difficult decisions often faced by seniors with dementia and their caregivers in primary care. They will receive five DBs by email, at a rate of 1 per week for 5 weeks.
15990963|NCT02956681|Behavioral|Intervention Group|Callers to California's toll-free breast/cervical screening phone service were screened for family history. Callers identified as high risk will be told that a genetic counselor will call them back to offer them a free genetic counseling appointment and that a brochure will be sent. A UCSF/SFGH genetic counseling assistant will call them back within a few days to offer them a free genetic counseling appointment at SFGH.
15990964|NCT02956681|Behavioral|Delayed Intervention Group|This is a randomized delayed intervention control trial in which eligible callers to California's toll-free breast/cervical screening phone service were screened for family history. Callers identified as high risk will be told that they are eligible to speak to a genetic counselor who is available at no charge at SFGH and that they will be sent a brochure with information on where to call.
15990965|NCT02956668|Other|Blindsight Training associated to tDCS|The patient undergo visual rehabilitation while his brain is electrically stimulated with tDCS.
15990966|NCT02956668|Other|Blindsight Training alone|The patient undergo visual rehabilitation
15990967|NCT02956655|Other|Fasting therapy|The target fasting plasma glucose is set below 6.1mmol/l and the postprandial blood glucose below 8.0 mmol/l. After intervention, all the accomplished patients undergo a 1 year period follow-up. Lifestyle guidance will be offered throughout the follow-up.
15991022|NCT02956356|Dietary Supplement|Control treatment + meal intake|Control granulates (maize starch and long-chain fatty acids) with powder; test meal (ham sandwiches: 50g bread, 10g butter, 29g ham (pork); 247 kcal/sandwich) and tap water)
15991023|NCT02956356|Dietary Supplement|SATIOSTAT treatment + meal intake|SATIOSTAT granulates (hydrocolloids (fibers) and long-chain fatty acids) with powder; test meal (ham sandwiches: 50g bread, 10g butter, 29g ham (pork); 247 kcal/sandwich) and tap water)
15991257|NCT02954692|Drug|meglitinides|"Pharmaceutical form: tablet
~Route of administration: oral"
15990968|NCT02956655|Drug|Insulin intensive therapy: Human Insulin (Novolin-R, Novo Nordisk)|"Human Insulin (Novolin-R, Novo Nordisk)
~Device: H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland
~The target fasting plasma glucose is set below 6.1mmol/l and the postprandial blood glucose below 8.0 mmol/l. If the glucose target cannot be achieved within 2 weeks or the subjects are not tolerated with this therapy, these members will be exclude from the study and they will receive other treatment according the standard treatment guidelines. After intervention, all the accomplished patients will undergo a 1 year period follow-up. Lifestyle guidance will be offered throughout the follow-up."
15990969|NCT02956655|Other|Exercise|Middle intense exercise for at least 2 hours,e.g. brisk walking or jogging
15990970|NCT02956655|Behavioral|Lifestyle guidance|Lifestyle guidance is provided by specific physicians through phone calls
15990971|NCT02956655|Device|H-Tron Plus V100; Disetronic Medical System, Burgdorf, Switzerland|
15990972|NCT02956642|Device|Livongo Health System|Participants will be asked to use the Livongo Health System to manage their blood glucose.
15990973|NCT02956642|Device|iHealth Glucose Meter|Participants will be asked to use the iHealth Glucose Meter to take blood glucose measurements.
15990974|NCT02956629|Drug|Uprifosbuvir|Participants take 3 tablets each containing 150 mg uprifosbuvir q.d. by mouth.
15990975|NCT02956629|Drug|Ruzasvir|Participants take 3 capsules each containing 60 mg RZR q.d. by mouth.
15990976|NCT02956629|Drug|Ribavirin|RBV 200 mg capsules will be taken according to package instructions for a maximum of 16 weeks for any GT that meets virologic futility rules on uprifosbuvir + RZR alone.
15990977|NCT02956616|Drug|ketorolac|Ketorolac, sold under the brand name Toradol among others, is a nonsteroidal anti-inflammatory drug in the family of heterocyclic acetic acid derivatives, used as an analgesic. It is considered a first-generation NSAID. Ketorolac acts by inhibiting the bodily synthesis of prostaglandins.
15990978|NCT02956616|Other|Chewing Gum|Xylitol chewing gum will be provided to patients immediately after the procedure and will be provided 3 times per day for a duration of 30 minutes at each time, based on a metanalysis and systematic review. Patient's will be encouraged on its use for return of bowel function.
15990979|NCT02956616|Procedure|Enhanced Recovery Protocol|enhanced recovery protocol (detailed previously) will include several evidence-based recommendations including early ambulation, early diet initiation, early removal of urinary catheter, early removal of postoperative dressing and standing ketorolac for 24 hours postoperatively.
15990981|NCT02956590|Drug|Pitavastatin|Statin
15990982|NCT02956590|Drug|Placebo|Placebo
15990983|NCT02956564|Procedure|intrauterine intervention|choose different surgeries according to different causes
15990984|NCT02956551|Biological|DC vaccine|subcutaneous administration
15990985|NCT02956538|Drug|Thalidomide|
15990986|NCT02956538|Drug|placebo(for thalidomide)|sugar pill manufactured to mimic thalidomide 100mg tablet
15990987|NCT02956525|Drug|Dexibuprofen|Dexibuprofen 200 mg
15990988|NCT02956512|Drug|Dexibuprofen|Dexibuprofen 300mg
15990989|NCT02956499|Drug|APX001 single dose 1|
15990990|NCT02956499|Drug|APX001 single dose 2|
15990991|NCT02956499|Drug|APX001 single dose 3|
15990992|NCT02956499|Drug|APX001 single dose 4|
15990993|NCT02956499|Drug|APX001 single dose 5|
15990994|NCT02956499|Drug|APX001 single dose 6|
15990995|NCT02956499|Drug|APX001 multiple dose 1|
15990996|NCT02956499|Drug|APX001 multiple dose 2|
15990997|NCT02956499|Drug|APX001 multiple dose 3|
15990998|NCT02956499|Drug|APX001 multiple dose 4|
15990999|NCT02956499|Drug|Matching Placebo|
15991000|NCT02956486|Drug|Elenbecestat|Oral tablet.
15991001|NCT02956486|Drug|Placebo|Oral tablet.
15991002|NCT02956473|Device|Supine MRI|
15991003|NCT02956473|Other|Neoadjuvant Therapy|
15991004|NCT02956473|Device|Ultrasound|
15991005|NCT02956473|Device|Mammography|
15991006|NCT02956473|Procedure|Standard of Care|
15991007|NCT02956460|Device|fanfilcon A|contact lens
15991008|NCT02956460|Device|senofilcon A|contact lens
15991009|NCT02956447|Drug|Kisspeptin 112-121|0.313 µg/kg IV
15991010|NCT02956447|Drug|Gonadotropin Releasing Hormone (GnRH)|0.075 ug/kg IV
15991011|NCT02956434|Behavioral|Brief Family Intervention|Two 50-minute sessions aimed at helping family members be most supportive to their loved one's treatment goals.
15991012|NCT02956421|Biological|RABIPUR®|Biological rabies vaccine
15991013|NCT02956421|Biological|PIKA rabies vaccine|Biological rabies vaccine
15991014|NCT02956408|Dietary Supplement|Vitamin D3|Patients will be prescribed either 2000 IU or 6000 IU of vitamin D3 per day. They will go to a pharmacy and purchase a vitamin D3 supplement in their preferred form (eg gummy, liquid, chew, tablet, capsule)
15991015|NCT02956395|Other|Integrated care intervention|"Integrated care intervention is implemented by a multidisciplinary team from the hospital and from the Primary Care.
~The intervention after hospital discharge a) Phone call at 24 hours; b) Home visit at 72 hours after discharge by one member of the transitional care team, if is needed; During this visit, the therapeutic plan for each patient will be customized to their individual frailty factors and shared with the primary care team. Reinforcement of the logistics for treatment of co-morbidities and social support will be done accordingly; c) Accessibility to the point of care available 24 hours/day ; d) Accessibility to the individualized PHF, as self-management tool ; d) appointment at 1m after discharge and after 12 m"
15991016|NCT02956382|Drug|Ibrutinib|Ibrutinib is dispensed as a capsule.
15991017|NCT02956382|Drug|Venetoclax|Venetoclax is dispensed as a tablet.
15991018|NCT02956369|Dietary Supplement|Control|Control granulates (maize starch and long-chain fatty acids) with powder
15991019|NCT02956369|Dietary Supplement|SATIOSTAT|SATIOSTAT granulates (hydrocolloids (fibers) and long-chain fatty acids) with powder
15991020|NCT02956356|Dietary Supplement|Control treatment + oral glucose|Control granulates (maize starch and long-chain fatty acids) with powder; 75g oral glucose load
15991021|NCT02956356|Dietary Supplement|SATIOSTAT treatment + oral glucose|SATIOSTAT granulates (hydrocolloids (fibers) and long-chain fatty acids) with powder; 75g oral glucose load
15991024|NCT02956343|Device|Five minutes pulse wave recording|Patients will wear a smart watch and a wristband each at one arm. A standard egg (lead I) and pig signals from the wearables will be recorded for five minutes.
15991025|NCT02956317|Drug|STP705|The Cotsiranib drug substance is composed of two siRNA oligonucleotides, targeting TGF-β1 and Cox-2 mRNA respectively, and formulated in nanoparticles with Histidine-Lysine co-Polymer (HKP) peptide at a ratio of 1:4 in mass weight (siRNA:peptide), which is further formulated into a dry powder drug product. The administration route would be intra-dermal injection.
15991026|NCT02956317|Drug|Placebo|Normal Saline
15991027|NCT02956304|Other|PMv stimulation (iTBS)|PMv stimulation (iTBS)
15991028|NCT02956304|Other|PMv inhibition (cTBS)|PMv inhibition (cTBS)
15991029|NCT02956304|Other|Control (SHAM)|Control (SHAM)
15991030|NCT02956291|Device|Magnetic Resonance Fingerprinting|Non-contrast MRF acquisition will be acquired through the region of tumor in all patients. For patients receiving intravenous gadolinium based contrast, a post contrast MRF acquisition will also be acquired. This acquisition will be skipped in patients who do not receive or are not eligible for receiving IV contrast as a part of their clinical scan. The research scan will take approximately 10-15 minutes
15991031|NCT02956278|Drug|Allopurinol|
15991032|NCT02956278|Other|Placebo|lactose placebo pill
15991033|NCT02956265|Device|bimodal optical spectroscopy|an optical fiber will be put in gentle contact with the patient's skin in order to acquire optical spectra
15991034|NCT02956252|Procedure|Spinal anesthesia|Spinal anesthesia was used in patients who underwent LC
15991035|NCT02956252|Procedure|General anesthesia|General anesthesia was used in patients who underwent LC
15991036|NCT02956239|Procedure|Thermocoagulation (device)|Thermocoagulation uses heat injury to destroy the abnormal dysplastic cells of the cervix
15991037|NCT02956239|Procedure|Cryotherapy (device)|Cryotherapy uses cold injury to destroy the abnormal dysplastic cells of the cervix
15991038|NCT02956239|Procedure|LEEP (device)|The abnormal area of the cervix is excised with a thin metallic loop driven by electrosurgical unit
15991039|NCT02956226|Drug|Cannabinoids - 99% pure cannabinoids mix|99% pure cannabidiol (CBD) and 99% pure Δ9-tetrahydrocannabinol (THC) in a 20:1 ratio (B.O.L Pharma, Israel), in a 160/8.0 mg per mL (CBD/THC) olive oil-based solution.
15991040|NCT02956226|Drug|Placebo|Olive oil and flavors solution.
15991041|NCT02956226|Drug|Cannabinoids - whole plant extract|Whole plant extract enriched with cannabidiol (CBD) and Δ9-tetrahydrocannabinol (THC) to achieve 20:1 ratio (B.O.L Pharma, Israel), in a 160/8.0 mg per mL (CBD/THC) olive oil-based solution.
15991042|NCT02956213|Other|HEPA portable air filter|A high efficiency (MERV17) portable air filter (HEPA portable air filter) will be placed in the subject's bedroom and will run 24/7 for the duration of the study.
15991043|NCT02956213|Other|Sham Control/Active Comparator|A portable air filtering device will be placed with no high-efficiency air filter, but only the basic carbon filter in place. Then at cross over, there will be an active HEPA portable air filter used
15991044|NCT02956200|Drug|Fingolimod|Patients randomized to fingolimod will also receive oral fingolimod (Gilenya, Novartis) at a dosage of 0.5 mg once daily, for three consecutive days, with the first dose being given at the time in which patients are enrolled which is about one hour prior to mechanical thrombectomy.
15991045|NCT02956187|Behavioral|Biofeedback|Functional outlet obstruction will be treated by biofeedback: sessions of biofeedback guided by anorectal manometry combined with instructions for daily exercizing for 4 weeks.
15991046|NCT02956187|Dietary Supplement|Fiber supplement|3.5 g plantago ovata per day will be administered for 4 weeks.
15991047|NCT02956174|Device|Co-Cr single crown|
15991048|NCT02956174|Other|Periodontal parameters|
15991049|NCT02956161|Device|Stimulation of up-phase of sleep slow oscillation|
15991050|NCT02956161|Device|Random stimulation of up phase of sleep slow oscillation|
15991051|NCT02956161|Device|No stimulation|
15991052|NCT02956148|Radiation|Radioligand [18F]MNI-659|The effective radiation dose for the injection of [18F]MNI-659 is approximately 5.6 mSv (approximately 2 years of background radiation in Sweden) for an average person weighing 70 kg.
15991053|NCT02956122|Biological|GLASSIA|GLASSIA [Alpha1-Proteinase Inhibitor (Human)]
15991054|NCT02956122|Drug|methylprednisolone or equivalent steroid|The conventional steroid treatment (methylprednisolone or equivalent steroid) will be supplied by the investigators per their institutional practice.
15991055|NCT02956122|Biological|Albumin|The control vials contain human albumin 20% in 50 mL normal saline solution in glass vials (for non-United States (US) Countries), or Flexbumin 25% in 50 mL in normal saline solution in plastic IV bags (for US).
15991056|NCT02956109|Drug|Finerenone (BAY94-8862): 1 0mg tablet|10 mg finerenone immediate-release tablet; single dose in the fasting condition
15991057|NCT02956109|Drug|Finerenone (BAY94-8862): 5 X 0.25 mg oro-dispersible tablets|5 x 0.25 mg (1.25 mg) oro-dispersible tablets; single dose in the fasting condition
15991058|NCT02956109|Drug|Finerenone (BAY94-8862): 1.25 mg oro-dispersible tablet|1.25 mg finerenone oro-dispersible tablets; single dose in the fasting condition or in the fed condition
15991059|NCT02956096|Device|Transcranial direct current stimulation (tDCS)|The active tDCS and placebo will be applied to anode electrode on left temporal cortex placed on the scalp in the region T3. The cathode electrode on the middle deltoid muscle contralateral to the anode.
15991060|NCT02956096|Device|training on the running belt|The running in the treadmill will be held on a single training session and the speed of the cardiopulmonary exercise testing and slope from 60 to 80% of the maximum achieved in cardiopulmonary testing, in order that the patient reaches 60% to 70% of the heart rate reserve.
15991061|NCT02956083|Other|Systane Balance eye drops|Propylene Glycol 0.6% Over the counter lipid based artificial tears.
15991062|NCT02956083|Other|Systane Contacts eye drops|Hydroxypropyl methycellulose over the counter non-lipid based artificial tears
15991063|NCT02956083|Other|saline|Saline - no brand name
15991102|NCT02955797|Biological|Meningococcal polysaccharide groups A, C, W-135 and Y Conjugate vaccine|0.5 mL, Intramuscular
15991103|NCT02955784|Device|Sinasprite Mobile App|Mobile App
15991216|NCT02954978|Drug|Placebo Oral Capsule|"25 patients in group 1 will receive Placebo (sugar pill) one (1) capsule once daily (taken without a meal) for 12 months and 3 months follow up."
15991587|NCT02952573|Drug|JNJ-42756493|Once daily dosing
15991064|NCT02956070|Drug|Dexamethasone acetate|The volunteers in the Dexamethasone acetate group (experimental group) will receive six capsules of dexamethasone 8 mg each to be administered orally, initially two days before the first bleaching query as follows: 8 mg (1 capsule) 9 am two days before the first clinical session whitening; 8 mg (1 capsule) the 9 am to 1 day before session whitening, 8 mg (1 capsule) to 9 am on the day of the first session of whitening.Clinical intervention: 1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A placebo gel will be applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes .
15991065|NCT02956070|Drug|Potassium Nitrate|The volunteers in the Potassium Nitrate Group (Placebo group) will receive 6 placebo capsules, who contained the same components of de dexamethasone drug except the active ingredient (starch [50%], lactose monohydrate [35%], dibasic calcium phosphate [14%], and magnesium stearate [1%]).Clinical session:1- Dry teeth and apply Gingival Barrier to both arches. 2- Light cure. 3- Firmly attach a mixing nozzle to the Pola Office+. 4- Apply a thin layer of gel to all teeth undergoing treatment. 5- Leave gel on for 8 minutes. 6- Suction it off. 7- Repeat steps 5-6 twice times. 8- After the last application, suction all the gel off, then wash and apply suction. 9- Remove Gingival Barrier. 10- A desensitizing gel containing 6% potassium nitrate will be applied with a brush on the labial surface of the teeth whitened for 2 to 3 minutes .
15991066|NCT02956057|Drug|Polyethylene Glycols|
15991067|NCT02956057|Drug|Natrium picosulfate / Magnesium citrate|
15991068|NCT02956057|Drug|Polyethylene glycol / Ascorbic acid|
15991069|NCT02956044|Drug|Bexagliflozin|Bexagliflozin tablets, 20 mg
15991070|NCT02956044|Drug|Metformin|1000 mg metformin
15991071|NCT02956044|Drug|Glimepiride|4 mg glimepiride
15991072|NCT02956044|Drug|Sitagliptin|100 mg sitagliptin
15991073|NCT02956031|Other|Screening|Cervical specimen obtained using speculum examination and cervical collection bush.
15991074|NCT02956031|Other|Colposcopy|Vaginal speculum examination followed by application of 2% acetic acid and lugol's iodine with inspection with colposcope and punch biopsies taken of abnormal areas.
15991075|NCT02956031|Procedure|LLETZ|The above (see colposcopy) is followed by local anaesthetic with two dentist's ampoules of lignocaine and large loop excision using coagulation of the abnormal area (usually 2 x 3 x 1 cm).
15991076|NCT02956005|Drug|ENVARSUS®|ENVARSUS XR is a form of the anti-rejection drug, tacrolimus, for people who have had a kidney transplant
15991077|NCT02955992|Behavioral|Improving communication during the end-of-life process|
15991078|NCT02955979|Other|CT scan with iodinated contrast agents|"Before the CT scan, the investigators with iodinated contrast agents, the following data will be collected in the medical record: creatinine prior to injection, comorbidities and child characteristics, associated treatments and risk factors of acute renal failure, as well as the injection pattern.
~After the CT scan the investigators will collect the characteristics of the injection type, osmolarity and volume of contrast used and the appearance of a possible allergic reaction.
~Then 24 and 48 hours and day 7 will collect serum creatinine, urine output and vital replacement therapies may be necessary."
15991079|NCT02955966|Device|imaging 18F-FDG-PET/CT|18F-FDG PET Scan at Day 0, W6 and W12
15991080|NCT02955966|Biological|Blood collection|Blood collection at D0, D3, W1, W2, W4, W6, W12, end of treatment.
15991081|NCT02955953|Drug|LY2963016|Administered SC
15991082|NCT02955940|Drug|Ruxolitinib|5 mg BID
15991083|NCT02955940|Drug|Capecitabine|Capecitabine at the same dose provided in the parent study at the time of the rollover.
15991084|NCT02955940|Drug|Regorafenib|Regorafenib at the same dose provided in the parent study at the time of the rollover.
15991085|NCT02955927|Drug|0.01% atropine eye drops|
15991086|NCT02955927|Device|ortho-k|
15991087|NCT02955901|Other|3 day low residue diet prior to the colonoscopy|3 day low residue diet prior to the colonoscopy
15991088|NCT02955901|Other|1 day low residue diet prior to the colonoscopy|3 day low residue diet prior to the colonoscopy
15991089|NCT02955888|Drug|PBI4050|Investigational Medicinal Product
15991090|NCT02955888|Drug|Placebo|Comparator
15991091|NCT02955875|Behavioral|Pharmaceutical care|Outpatient drug history management, drug regimen review, patient counseling and education before and/or after physician evaluation on the day of facility visit
15991092|NCT02955862|Other|Vietnam Cryptococcal Retention in Care Study (CRICS)|"Drug: Fluconazole HIV-infected patients with CD4 ≤100 cells/μL who present for HIV care at outpatient clinics (OPCs) in Vietnam where CrAg screening is offered will be recruited into the study. Study participants will be screened for cryptococcal antigen using the Lateral Flow Assay (LFA). Those who are CrAg-positive, but have no features of central nervous system (CNS) disease, will be treated with high-dose fluconazole.
~Other Names:
~• Fluconazole"
15991093|NCT02955849|Device|SLT laser|Patients will be offered initial SLT laser by doctors
15991094|NCT02955823|Drug|Rituximab-Dexamethasone-Lenalidomide|"st CYCLE: Rituximab 375 mg/m2 i.v. on days 1,8,15; Dexamethasone 5 mg p.o. on days 1,8,15,22; Lenalidomide 15 mg/day p.o. day 2-22
~nd-4th CYCLE: Rituximab 375 mg/m2 i.v. on day 1; Lenalidomide 20 mg/day p.o. from day 2 to day 22 At the end of 4th CYCLE disease restaging: - if ≥ PR continues with the 5th and 6th cycle: Rituximab 375 mg/m2 i.v. on day 1, Lenalidomide 20 mg /day p.o. day 2-22
~if <PR stops the treatment, only follow-up At the end of the 6th CYCLE disease restaging: - if ≥ PR continues with beyond the 6th cycle with Lenalidomide 10mg dd1-21q28 until cycle 12th
~if <PR stops the treatment, only follow-up Then, accordingly response rate after the sixth cycle assessment(≥ PR) lenalidomide will be continued at 10 mg dd1-21q28 until 12th cycle or unacceptable toxicity."
15991095|NCT02955810|Drug|Daratumumab|
15991096|NCT02955810|Drug|Cyclophosphamide|
15991097|NCT02955810|Drug|Bortezomib|
15991098|NCT02955810|Drug|Dexamethasone|
15991099|NCT02955797|Biological|Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine|0.5 milliliter (mL), Intramuscular
15991100|NCT02955797|Biological|Meningococcal polysaccharide groups A, C, W-135 and Y Conjugate vaccine|0.5 mL, Intramuscular
15991101|NCT02955797|Biological|Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine|0.5 mL, Intramuscular
15993485|NCT02938468|Drug|Dexamethasone|
15991104|NCT02955771|Combination Product|PDT-Deuteporfin（6 hour)|Photodynamic therapy (PDT) involves the i.v. injection of Deuteporfin (7.5 mg/kg，Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd，Shanghai，China） followed by the illumination of the tumor. 6 hours after the injection,a laser light ( (wavelength,630 nm; light dose, 180 J/cm(2)；Guilin Xingda Photoelectric Medical Calinstrument Co., Ltd，,Fujian, China） will be applied to the tumor.The second courses of PDT may be given at 3-month intervals.
15991105|NCT02955771|Combination Product|PDT-Deuteporfin（9 hour)|Photodynamic therapy (PDT) involves the i.v. injection of Deuteporfin (7.5 mg/kg，Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd，Shanghai，China) followed by the illumination of the tumor.9 hours after the injection,a laser light ( (wavelength,630 nm; light dose, 180 J/cm(2)；Guilin Xingda Photoelectric Medical Calinstrument Co., Ltd，,Fujian, China) will be applied to the tumor. The second courses of PDT may be given at 3-month intervals.
15991106|NCT02955771|Device|stenting|The stenting procedure consists in the placement of plastic stents （Boston Scientific Corporation, MA,USA；or Cook Medical, Bloomington,USA）above the main tumors of the right and left hepatic bile ducts via endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC).
15991107|NCT02955758|Biological|Pembrolizumab|Given IV, 200mg fixed dose, every 3 weeks
15991108|NCT02955745|Other|Iodine-129|The present study is an observational study and does not therefore include an investigational product in the proper sense because the used tracer (semi-stable iodine isotope) has no physiological effect on the participants. 129I will be used as tracer to measure appearance in plasma, urine and stools after the oral administered of the 129I-tracer.
15991109|NCT02955732|Device|Dexmedetomidine|A 2-4 µg/kg dose of the study drug, 2 µg/kg of intranasal dexmedetomidine, will be administered using a LMA MAD Nasal™ -device approximately 20 min prior to planned sedation/anesthesia.
15991110|NCT02955719|Drug|Sertraline|
15991111|NCT02955719|Drug|Venlafaxine|
15991112|NCT02955719|Other|CBT/Psychological Therapy|
15991113|NCT02955719|Other|Psychiatric Consultation|
15991114|NCT02955719|Other|Lifestyle Intervention Resources|
15991115|NCT02955706|Drug|Acetyl-L-Carnitine|TID
15991116|NCT02955706|Drug|Placebo of Acetyl-L-Carnitine|TID
15991117|NCT02955693|Drug|LAS41008 120 mg / Fumaderm® 120 mg|Single dose of LAS41008 120 mg or Fumaderm® 120 mg in each Period
15991118|NCT02955680|Procedure|recorded maternal voice|"A voice recording will be performed before the operation. At a preoperative visit or preoperative clinic, informed consent was obtained before the recording. On a calm environment, the mother was asked to speak following sentences.
~OO (first name of child), wake up~. Let's go home with mommy. OO, wake up~. Open your eyes. Take a deep breath.  At the end of surgery, the recorded maternal voice was delivered to the child every 15 seconds until he/she wakes up."
15991119|NCT02955680|Procedure|recorded stranger's voice|"A voice recording will be performed before the operation. On a calm environment, a blinded female investigator was asked to speak following sentences.
~OO (first name of child), wake up~. Let's go home with mommy. OO, wake up~. Open your eyes. Take a deep breath. "
15991120|NCT02955667|Procedure|invivo microscopy group|patients receive invivo micro-colposcopy examination
15991121|NCT02955667|Procedure|normal group|patients receive normal colposcopy examination and the biopsy specimens are sent for pathological HE staining and analysis
15991122|NCT02955654|Behavioral|Acceptance and commitment therapy|Patients randomized to ACT will receive weekly 45-50 minute sessions delivered over 8 weeks by a therapist. ACT will include mindfulness,learning new methods to handle problems，acceptance of thoughts and feelings, learning to disempower thoughts and feelings, and values-based committed action.
15991123|NCT02955654|Drug|Aripiprazole|Patients randomized to aripiprazole group will be treated with aripiprazole at the dose of 10-20mg/day for 8 weeks.
15991124|NCT02955654|Behavioral|Stress management training|Patients randomized to SMT group will be received 2 introductory sessions and 15 treatment sessions. SMT will include training of stress manage-ment skills, progressive muscle relaxation,positive imagery, assertiveness training, and problem solving.
15991125|NCT02955641|Drug|Dexamethasone Disodium Phosphate 0.1%|four drops a day for four days after LPI treatment
15991126|NCT02955641|Drug|Nepafenac 0.1%|four drops a day for four days after LPI treatment
15991127|NCT02955641|Drug|Hydroxyethylcellulose 0.19%|four drops a day for four days after LPI treatment
15991128|NCT02955628|Drug|Ibrutinib-RICE|Ibrutinib will be added to RICE regimen for patients not achieving a complete remission at interim PET-2. Ibrutinib will be continued for up to 1 year after autologous transplantation.
15991129|NCT02955615|Drug|ILT-101|"Induction phase followed by weekly administrations of ILT-101 on top of SLE background therapy.
~SLE background therapy includes ..."
15991130|NCT02955615|Drug|Placebo|"Induction phase followed by weekly administrations of placebo on top of SLE background therapy.
~SLE background therapy includes ..."
15991131|NCT02955602|Drug|MBX-8025 2 mg Capsule|"Initial 8-week treatment:
~• MBX-8025 2 mg
~Extension:
~The 2 mg group will be started after safety and efficacy review of the 5 mg and the 10 mg groups has been completed.
~Subjects will initially enter the extension on their assigned dose. The dose might be up- or down-titrated after safety and efficacy data review of the first 8 weeks of treatment. During the extension, a subject's dose might be re-adjusted for safety or efficacy reasons."
15991132|NCT02955602|Drug|MBX-8025 5 mg Capsule|"Initial 8-week treatment:
~• MBX-8025 5 mg
~Extension:
~Subjects will initially enter the extension on their assigned dose. The dose might be up- or down-titrated after safety and efficacy data review of the first 8 weeks of treatment. During the extension, a subject's dose might be re-adjusted for safety or efficacy reasons."
15991133|NCT02955602|Drug|MBX-8025 10 mg Capsule|"Initial 8-week treatment:
~• MBX-8025 10 mg
~Extension:
~Subjects will initially enter the extension on their assigned dose. The dose might be up- or down-titrated after safety and efficacy data review of the first 8 weeks of treatment. During the extension, a subject's dose might be re-adjusted for safety or efficacy reasons."
15991134|NCT02955589|Drug|HBI-8000|Oral, twice weekly
15991135|NCT02955576|Device|Microneedle HA patch|"The microneedle HA patch were made of hyaluronic acid with microneedles which can enhance the drug permeation. All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment with microneedle HA patches.
~Microneedle HA patch (Therapass®, RMD-6.5A) was prepared at Raphas Co., Ltd. (Cheonan, South Korea).
~Daivobet® containing the active ingredients calcipotriol - betamethasone dipropionate was applied."
15991136|NCT02955576|Device|Patch|"The patch were made of hyaluronic acid with no microneedles to rule out the occlusion effect of microneedle HA patch. All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment with patches.
~Daivobet® containing the active ingredients calcipotriol - betamethasone dipropionate was applied.
~The hyaluronic acid patch was prepared at Raphas Co., Ltd. (Cheonan, South Korea) for this clinical trial, not for sale."
15991137|NCT02955576|Other|Control|"All lesions were treated with topical calcipotriol - betamethasone dipropionate ointment only.
~Daivobet® containing the active ingredients calcipotriol - betamethasone dipropionate was applied."
15991138|NCT02955563|Other|CSDM Web-Based Tool Intervention|The web and tablet-based tool is designed to help family members become familiar with ICU environment, routines, and clinicians, prepare for family meetings, and learn how to make values-based decisions for their loved one. The tool contains short videos, interactive exercises, and links to other resources. Family members work through the tool shortly after admission to the ICU, before each family meeting, and any other time they wish to during the ICU admission.
15991139|NCT02955550|Drug|rhIL-2|Human recombinant Interleukin-2
15991140|NCT02955550|Biological|PNK-007|PNK-007 is a culture-expanded cell population derived from human cord blood hematopoietic stem/progenitor cells.
15991141|NCT02955537|Other|MI-BP|MI-BP includes the following components: 1) Home blood pressure monitoring 2) Physical activity monitoring 3) Sodium intake self-monitoring 4) Physical activity and sodium intake goal setting 5) Educational messaging via push notification and in-app messaging 6) motivational messaging 7) tailored messaging relevant to individual participants and 8) medication reminders.
15991142|NCT02955524|Drug|Tetracaine 0.5%|One drop of 0.5% Proparacaine to nasolacrimal Duct to numb the ethmoidal nerve in the nasal passage on the side of the eye to be treated.
15991143|NCT02955524|Drug|Lidocaine hydrochloride ophthalmic gel 3.5%|1ml of lidocaine gel is placed over the conjunctivae of the eye to be treated after the patient is under general anesthesia and before the procedure
15991144|NCT02955511|Device|Blade MAC size 3|Patient will be intubated using the DL- Blade MAC size 3
15991145|NCT02955511|Device|Blade MAC size 3.5|Patient will be intubated using the DL- Blade MAC size 3.5
15991146|NCT02955511|Device|Inscope Blade size 3.5|Patient will be intubated using the Inscope Blade size 3.5
15991147|NCT02955498|Drug|Sevikar tab. 10/40mg|Reference drug: Sevikar tab. 10/40mg, 1T, single oral administration in the fasted state
15991148|NCT02955498|Drug|Lodivikar tab. 5/40mg|Test drug: Lodivikar tab 5/40mg, 1T, single oral administration in the fasted state
15991149|NCT02955485|Other|Patients do not undergo any type of interventions, but standard care if offered and accepted.|
15991150|NCT02955472|Drug|GLA5PR GLARS-NF3 tablet 150mg|A new formulation(3rd.) of Pregabalin CR tablet
15991151|NCT02955472|Drug|GLA5PR GLARS-NF1 tablet 150mg|A new formulation(1st.) of Pregabalin CR tablet
15991152|NCT02955459|Drug|VNRX-5133|
15991153|NCT02955459|Drug|Placebo|
15991154|NCT02955446|Drug|PF-03084014|Two patients enrolled in this study will continue receiving 80mg BID doses of PF-03084014, which was the same dose/schedule of their latest cycle on protocol A8641014. PF-03084014 will be administered twice a day in the morning and evening divided by approximately 12 hours. PF-03084014 should be administered in cycles of 21 days continuously.
15991155|NCT02955433|Other|Rideshare-based transportation|
15991156|NCT02955420|Drug|BC 007|
15991157|NCT02955420|Drug|NaCl 0.9 %|
15991158|NCT02955407|Other|no intervention|observational case-control study
15991159|NCT02955394|Drug|Enzalutamide|160mg of Enzalutamide will be given daily in conjunction with Fulvestrant.
15991160|NCT02955394|Drug|Fulvestrant|500mg Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC)
15991161|NCT02955381|Device|Restylane Silk, 1.0 ml|Restylane® Silk was approved in 2014 submucosal implantation for lip augmentation and dermal implantation for correction of perioral rhytids in patients over the age of 21.
15991162|NCT02955381|Device|Saline, 1.0 ml|Simple saline solution. To be used as placebo (control). No active ingredients.
15991163|NCT02955368|Drug|DP-R212|DP-R212 + C1-R212 placebo + C2-R212 placebo
15991164|NCT02955368|Drug|C1-R212|DP-R212 placebo + C1-R212 + C2-R212 placebo
15991165|NCT02955368|Drug|C2-R212|DP-R212 placebo + C1-R212 placebo + C2-R212
15991166|NCT02955355|Biological|HYQVIA|Participants will receive subcutaneous (SC) HYQVIA/HyQvia which contains both Immune Globulin Infusion 10% (Human) (IGI, 10%) and recombinant human hyaluronidase (rHuPH20).
15991167|NCT02955342|Other|no intervention|no intervention
15991168|NCT02955329|Drug|Nicotine|Participants will vape tobacco leaves with nicotine out of the PAX device.
15991169|NCT02955329|Drug|Cannabis|Participants will vape marijuana leaves with nicotine out of the PAX device.
15991170|NCT02955329|Device|PAX Loose Leaf Vaporizer|In all three arms, the participant will be using the same PAX electronic cigarette device. The only difference is whether the participant will be vaping nicotine only, THC only, or nicotine and THC.
15991171|NCT02955303|Other|TECH: Tablet Enhancement of Cognition and Health|cognitive training using touchscreen tablet gaming applications
15991176|NCT02955277|Other|TECH: Tablet Enhancement of Cognition and Health|TECH protocol - cognitive training using touchscreen tablet gaming applications
15991177|NCT02955264|Dietary Supplement|D-Galactose|D-Galactose is an oral powdered dietary supplement to be taken by mouth.
15991178|NCT02955251|Drug|ABBV-428|ABBV-428 will be administered by intravenous infusion in 28-day dosing cycles on Day 1 and Day 15.
15991179|NCT02955251|Drug|Nivolumab|Nivolumab will be administered by intravenous infusion according to approved dose and dosing schedules.
15991212|NCT02954991|Drug|Glesatinib|Glesatinib is a small molecule multi-targeted receptor tyrosine kinase inhibitor
15991213|NCT02954991|Drug|Sitravatinib|Sitravatinib is a small molecule inhibitor of receptor tyrosine kinases.
15991214|NCT02954991|Drug|Mocetinostat|Mocetinostat is an HDAC inhibitor.
15991215|NCT02954991|Drug|Nivolumab|nivolumab is a programmed death receptor-1 (PD-1) blocking antibody
15991180|NCT02955238|Behavioral|Special Intervention|"Participants randomized into the SI group will participate in four group health education classes and seven clinical visits per year with the patient care team. The patient care team will be comprised of a mid-level clinician and a Community Health Worker (CHW).
~Content and materials utilized in the group health education classes are derived from the validated and translated curriculum Pasos Adelante , developed and refined by the CDC. Methods for training CHWs will be derived from the Pasos Adelante Curriculum."
15991181|NCT02955225|Device|Active Moticon OpenGO insole|A Moticon OpenGO insole measures shoe pressure and connects/sends data to a ANT+ enabled smartphone.
15991182|NCT02955225|Device|Passive shoe insole|A deactivated insole measures shoe pressure only.
15991183|NCT02955212|Drug|Upadacitinib|Tablets for oral administration
15991184|NCT02955212|Drug|Placebo|Tablets for oral administration
15991185|NCT02955199|Behavioral|Mothering From the Inside Out (MIO)|Mothering from the Inside Out (MIO) is a 12 session individual parenting therapy designed for mothers enrolled in treatment for drug and/or alcohol addiction and caring for a child between 11 and 60 months of age. MIO aims to promote their capacity for parental reflective functioning (the capacity to recognize and make sense of their own and their child's difficult emotions during challenging parenting situations).
15991186|NCT02955199|Behavioral|Parent Education|Parent Education (PE) is a 12 session individual parent counseling intervention designed for mothers enrolled in treatment for drug and/or alcohol addiction and caring for a child between 11 and 60 months of age. PE provides psycho-education about child development and parenting strategies typically available at community agencies on parenting. PE is designed to control for active treatment, treatment dose, and individualized intervention approach.
15991187|NCT02955186|Drug|Saracatinib|Saracatinib 125 mg once per day for 8 days
15991188|NCT02955186|Drug|Placebos|Placebo once per day for 8 days
15991189|NCT02955173|Procedure|Surgery|Laparoscopic or open surgery for resection of gastric or rectal cancer
15991190|NCT02955160|Biological|Multivalent|Pneumococcal conjugate vaccine
15991191|NCT02955160|Biological|Tdap|Tetanus, diphtheria, and pertussis vaccine
15991192|NCT02955147|Drug|Ustekinumab|Ustekinumab is a humanized monoclonal antibody that targets the p40 subunit of IL-12 and IL-23 and inhibits cytokine - cytokine receptor coupling and signaling
15991193|NCT02955147|Drug|Prednisone|Prednisone is an anti-inflammatory medication
15991194|NCT02955134|Drug|Talcid®|Talcid® is allowed to be taken when patients feel stomach pain, acid reflux or heartburn. Continuous taking time should not exceed one week.
15991195|NCT02955134|Drug|Chinese medicine prescription|"The Chinese medicine application prescription is composed of pinellia 9g, radix scutellariae 10g, rhizoma coptidis 8g, rhizoma zingiberis 10g, radix curcumae 10g, rhizoma atractylodis 10g, roasted bighead atractylodes rhizome 10g, radix astragali 15g, spreading hedyotis herb 20g, scutellariae barbatae 20g, salvia miltiorrhiza bge 10g, the stem of noble dendrobium 10g, radix pseudostellariae 10g, fructus aurantii immaturus 10g, cortex magnoliae officinalis 10g, rhizoma curcumae 10g, ginger 3g, jujube 6g.
~Patients take 200ml each time, twice a day. Treatment duration are 24 weeks."
15991196|NCT02955134|Drug|Placebo|The placebo is simulate granule of Chinese medicine application prescription. Patients take 200ml each time, twice a day. Treatment duration are 24 weeks.
15991197|NCT02955134|Drug|Compound Azimtamide Entieric-coated Tablets|Compound Azimtamide Entieric-coated Tablets are qualified by China Food and Drug Administration. These tablets are allowed to be taken when patients feel fullness, belching or anorexia. Continuous taking time should not exceed one week.
15991198|NCT02955121|Other|Prescriber Access to Genetic Information|
15991199|NCT02955108|Procedure|Distractive Auditory Stimuli|"Participants will self-select 1 music piece from a list of choices to keep the rhythm and tempo consistent throughout the 6MWT. The instructions to participants for selecting the music will be standardized. TThe music volume will be standardized to be moderately loud as rated by participants for the music condition. Participants will not be specifically instructed to synchronize their walking movements with the music tempo. The music is based on a cognitive therapy (distraction) strategy conceptual framework. Music will be played during the 6MWT (in-task) only."
15991200|NCT02955108|Procedure|No Distractive Auditory Stimuli|Participants will wear headphones with no music playing
15991201|NCT02955095|Device|Quit Smoking Phone Application|The app will be downloaded on participants' phones, and used by the participant for 30 days to make a quit attempt. Participants will be encouraged to use the app every day and to utilize all of its features, including features such as setting a quit date, taking the assessment section, and entering cigarette use and reasons for cravings
15991202|NCT02955082|Drug|Carboplatin|Intravenous carboplatin infusion every 3 weeks.
15991203|NCT02955069|Drug|PDR001|PDR001 was administered at a dose of 400 mg via intravenous infusion once every 4 weeks (Q4W). PDR001 was administered on Day 1 of every cycle. Each cycle was 28 days.
15991204|NCT02955056|Drug|Forsteo|20 micrograms/80 microlitres solution for injection in pre-filled pen
15991205|NCT02955043|Behavioral|Behavioral techniques|"Improve nighttime sleep: Participants will receive a modified form of cognitive-behavioral therapy for insomnia with a primary focus on stimulus control, a set of techniques to strengthen the association between bed and sleep and weaken its association with stimulating behaviors.
~Increase daytime activity: Participants will receive instruction in activity management strategies including prioritizing activities, planning activities during peak energy, activity pacing, and alternating between rest and activity. Participants will be provided with a basic step-count pedometer to enhance ability to self-monitor activity and increase motivation for activity.
~The intervention will be adapted to individual needs based on assessments of sleep and activity patterns."
15991206|NCT02955030|Biological|NSV0001|sublingual
15991207|NCT02955030|Biological|"Influenza HA vaccine Biken HA"|subcutaneous
15991208|NCT02955030|Biological|Placebo|sublingual
15991209|NCT02955017|Behavioral|traditional follow_up|"Multidisciplinary support with educational face to face family based intervention at 6, 9 and 12 months after inclusion.
~Two days of a complete medical check at 9 and 15 months"
15991210|NCT02955017|Behavioral|"distance follow-up new technologies"|"Multidisciplinary support with long distance monitoring Mobile apps.
~Two days of a complete medical check at 9 and 15 months"
15991211|NCT02955004|Procedure|Electrical cardioversion|Transthoracic direct current electrical cardioversion
15991255|NCT02954692|Drug|metformin|"Pharmaceutical form: tablet
~Route of administration: oral"
15991217|NCT02954978|Drug|Nilotinib 150mg oral capsule [Tasigna]|25 patients in group 2 will receive 150mg Nilotinib one (1) capsule once daily (taken without a meal) for 12 months and 3 months follow up.
15991218|NCT02954978|Drug|Nilotinib 300mg oral capsule [Tasigna]|25 patients in group 3 will receive 300mg Nilotinib one (1) capsule once daily (taken without a meal) for 12 months and 3 months follow up.
15991219|NCT02954965|Behavioral|Reward|Brief behavioral intervention (administered during a 45-minute phone call) that is designed to improve graduate student burnout by helping participants to identify activities that are rewarding and pleasurable and to integrate these activities into their schedule.
15991220|NCT02954965|Behavioral|Approach|Brief behavioral intervention (administered during a 45-minute phone call) that is designed to improve graduate student burnout by helping participants to identify activities that are challenging, but important to their long-term goals and values, and to integrate these activities into their schedule.
15991221|NCT02954952|Device|PSI Rev 1.X|PSI Rev 1.X is an older version of the PSI measurement.
15991222|NCT02954952|Device|PSI Rev 2.X|PSI Rev 2.X is a newer version of the PSI measurement.
15991223|NCT02954939|Drug|MMF-MMF|Class III/IV+/-V lupus nephritis patients to receive PRED+MMF
15991224|NCT02954939|Drug|CTX-AZA|Class III/IV+/-V lupus nephritis patients to receive PRED+CTX followed by AZA
15991225|NCT02954926|Drug|IVIG|IVIG at a dose of 500mg/kg within 12 h and 3 days of birth
15991226|NCT02954913|Procedure|Simultaneous Resection|Resections of 3 or more segments of the liver will be considered a major liver resection.(Reddy) The anesthetic technique and the order of liver resection or rectal resection will be determined by each surgeon's standards. It is recommended that a low central venous pressure be maintained in order to decrease intraoperative blood loss (Chen; Hughes) and that liver resection be performed prior to colorectal resection in order to keep a low central venous pressure during that part of the case.
15991227|NCT02954900|Other|RealRisks|RealRisks is a web-based patient decision aid with modules that present information about risk assessment and chemoprevention.
15991228|NCT02954900|Other|BNAV|Breast Cancer Risk Navigation (BNAV) tool is a web-based decision support tool with modules that present pertinent information for primary care providers regarding breast cancer risk assessment and preventative measures for their patients.
15991229|NCT02954887|Drug|GWP42003-P|Clear, colorless to yellow solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
15991230|NCT02954874|Other|Laboratory Biomarker Analysis|Correlative studies
15991231|NCT02954874|Other|Patient Observation|Undergo standard monitoring
15991232|NCT02954874|Biological|Pembrolizumab|Given IV
15991233|NCT02954874|Other|Quality-of-Life Assessment|Ancillary studies
15991234|NCT02954874|Other|Questionnaire Administration|Ancillary studies
15991235|NCT02954874|Radiation|Radiation Therapy|Undergo radiation therapy
15991236|NCT02954861|Other|No intervention|No intervention
15991237|NCT02954848|Drug|Placebo|TAK-438 placebo-matching tablets
15991238|NCT02954848|Drug|TAK-438 10 mg|TAK-438 tablets
15991239|NCT02954835|Device|Prevena|Prevena is a sterile silver dressing. On top of the silver dressing is an adhesive plastic, which is connected to a therapy unit through a short length suction tube.
15991240|NCT02954835|Device|Traditional Dressing|Sterile gauze dressing secured by tape.
15991241|NCT02954822|Drug|Evogliptin→Evogliptin+Glimepiride→Glimepiride|"Evogliptin 5mg will be administered for 7days and then glimepiride 4mg will be added on and administered with Evogliptin 5mg for 2 days. After the washout period for 10 days, Glimepiride 4mg will be administered for 2 days.
~Glimepiride : Glimepiride 4mg QD
~Evogliptin + Glimepiride : Evogliptin 5mg QD + Glimepiride 4mg QD"
15991242|NCT02954822|Drug|Glimepiride→Evogliptin→Evogliptin+Glimepiride|After 2 days of administration of Glimepiride 4mg follows the 10-day washout period. Afterwards Evogliptin 5mg will be administered for 7days and then glimepiride 4mg will be added on and administered with Evogliptin 5mg for 2 days.
15991243|NCT02954809|Device|Morning bright light therapy|Exposure to morning bright light therapy delivered with Green-Blue Re-Timer glasses for 30 minutes in the morning during one week.
15991244|NCT02954809|Device|Dim light|Exposure to dim light with Red-Yellow Re-Timer glasses for 30 minutes in the morning during one week.
15991245|NCT02954796|Drug|SGN-CD352A|On the first day of each 28-day cycle, SGN-CD352A will be given IV. The dose of SGN-CD352A is different in each cohort of the study, with the lowest dose in Cohort -1 (4 mcg/kg) and the highest in Cohort 6 (65 mcg/kg). Patients can only be enrolled into a higher dose level arm if lower doses have proven safe.
15991246|NCT02954783|Behavioral|High Intensity Interval Training|"Supervised aerobic High Intensity Interval Training program consisting of 4 weekly sessions of approximately 35 minutes. Patients will perform a test of maximum cardio-respiratory (VO2 peak test). Using the patient's individual wattmax, a personalized exercise program will be prescribed.
~After a light warm-up, patients will perform 25 min of aerobic high intensity interval training on a stationary bicycle, intervals will consist of cycles of HI intervals with 120% of wattmax for 1 min followed by recovery for 3 min at 30% of wattmax. Each session will be supervised by trained instructors to ensure proper technique, and progression in training load."
15991247|NCT02954783|Behavioral|Usual Care Observational Control|The reference group will receive the standard patient care program as provided by the Department of Urology, Rigshospitalet.This includes information regarding smoking cessation and alcohol reduction and a physiotherapist consultation regarding pelvic floor exercises. This group is allowed to exercise on their own initiative or participate in any standard care hospital- or municipality-based exercise program. This will be monitored by self-report.
15991248|NCT02954757|Procedure|HIFU treatment|High intensity focused ultrasound
15991249|NCT02954744|Procedure|HIFU treatment|High intensity focused ultrasound
15991250|NCT02954731|Behavioral|UP-CBT|"Psychotherapy in groups based on the Unified Protocol a third generation CBT-type psychotherapy"
15991251|NCT02954731|Behavioral|Standard-CBT|Psychotherapy in groups based on diagnosis specific, manualized, cognitive behavior therapy
15991252|NCT02954718|Other|activity training|
15991253|NCT02954705|Other|Non interventional study|This is a non interventional study because all levies are performed during visit planned for the care of patients.
15991254|NCT02954692|Drug|INSULIN GLARGINE (U300)|"Pharmaceutical form: pen for injection
~Route of administration: subcutaneous"
15991258|NCT02954692|Drug|thiazolidinediones|"Pharmaceutical form: tablet
~Route of administration: oral"
15991259|NCT02954692|Drug|alpha-glucosidase inhibitors|"Pharmaceutical form: tablet
~Route of administration: oral"
15991260|NCT02954692|Drug|GLP1 Receptor Agonist|"Pharmaceutical form: pen for injection
~Route of administration: subcutaneous"
15991261|NCT02954692|Drug|Dipeptidyl peptidase-IV (DPP-IV) inhibitors|"Pharmaceutical form: tablet
~Route of administration: oral"
15991262|NCT02954692|Drug|Sodium-glucose transport-2 (SGLT-2) inhibitors|"Pharmaceutical form: tablet
~Route of administration: oral"
15991263|NCT02954679|Other|Online self-administrated and anonymous survey questionnaire|The study will be conducted during a period of 3 years, between September 2016 and September 2019, according to a standardized methodology identical in every school involved and a procedure based on an online self-administrated and anonymous survey questionnaire. The questionnaire, elaborated on Limesurvey®, will be available for two successive academic years for all students aged more than 18 years old.
15991264|NCT02954666|Device|radio-frequency ablation|"Patients will undergo a tailored 'radio-frequency ablation' of the ARGP with the Smart Touch™ catheter or with the nMARQ™ catheter. Radiofrequency applications will be interrupted if no significant P-P interval shortening is observed after 30 seconds or if P-P interval is ≤ 550 ms during ablation.
~The ablation procedure is considered complete when one of the following conditions is fulfilled:
~P-P interval < 70% baseline procedural P-P interval after 5minute of waiting time; P-P interval < 600 ms after 5 minute of waiting time; 5 radiofrequency applications > 30 seconds have been delivered with the nMARQ™ catheter or 10 applications with the Smart Touch catheter."
15991265|NCT02954653|Biological|PF-06747143|PF 06747143 is a humanized IgG1 monoclonal antibody (mAb) that is an antagonist of CXCR4.
15991266|NCT02954653|Drug|Cytarabine|100-200 mg/m2 continuous infusion for 7 days)
15991267|NCT02954653|Drug|Daunorubicin|60-90 mg/m2 daily for 3 days
15991268|NCT02954653|Drug|Azacitidine|75 mg/m2 sub-cutaneous or intravenous for 7 days)
15991269|NCT02954653|Drug|Decitabine|20 mg/m2 continuous intravenous infusion for 5 days in a 4-week schedule
15991270|NCT02954640|Biological|Blood sampling|Additional blood sampling for the realization of the test on the gene panel
15991271|NCT02954627|Dietary Supplement|Dietary Supplement: Intensive dietary intervention|Participants receive a hypo-caloric formula diet containing 800 to 1,000 kcal/day. The formula diet consists of ready-to-use meal bars and powders to mix with water to make shakes, soups, or porridge. The weight loss programme consists of an 8-week period with full meal replacement by a standard liquid energy intake protocol. To facilitate compliance with the programme, participants will be scheduled for weekly facility-based group sessions with 6-8 participants led by a dietician. The recommendations for daily nutrient intake will be met.
15991272|NCT02954614|Behavioral|Active play in after school programs (ASP)|"A 15 hour training-program for ASP-staff aimed to increase active play and physical activity among children in ASPs. The program includes lectures, guided discussions and practical tasks focusing on increasing the staffs competence in how to support active play and PA among all children in the ASP
~A 8 hour course for local physiotherapists enabling them to guide ASP-staff during parts of the intervention period"
15991273|NCT02954601|Drug|ORMD-0801 (qd)|Dose 1 = ORMD-0801 (qd)
15991274|NCT02954601|Drug|ORMD-0801 (bid)|Dose 2 = ORMD-0801 (bid)
15991275|NCT02954601|Drug|ORMD-0801 (tid)|Dose 3 = ORMD-0801 (tid)
15991276|NCT02954601|Other|Placebo|fish oil placebo
15991277|NCT02954588|Dietary Supplement|Pyridoxamine|
15991278|NCT02954588|Dietary Supplement|Placebo|
15991279|NCT02954575|Drug|Wilate|
15991280|NCT02954562|Other|fMRI|Participants will undergo two to three fMRI scans
15991281|NCT02954549|Dietary Supplement|Vitamin D3|As in Arms
15991282|NCT02954536|Drug|pembrolizumab|
15991283|NCT02954536|Drug|trastuzumab|
15991284|NCT02954536|Drug|capecitabine|
15991285|NCT02954536|Drug|cisplatin|
15991286|NCT02954536|Drug|Oxaliplatin|Oxaliplatin may be administered instead, at a dose of 130 mg/m2/day as an I.V.over approximately 2 hours on Day 1 every 21-day cycles, up to a maximum of 8 cycles in the absence of disease progression or until other withdrawl criteria are met. Patients may begin with reduced dose of oxaliplatin 104 mg/m2 as starting dose if deemed necessary per the treating physician discretion. Oxaliplatin will be administered after the completion of the pembrolizumab infusion.
15991287|NCT02954536|Drug|5-Fluorouracil|Only for patients unable to take oral medications (because of certain circumstances such as malabsorption, difficulty swallowing, or other conditions that could affect intake of oral capecitabine medication), 5-FU may be administered instead, at a dose of 800 mg/m2/day as a continuous infusion over 5 days (Day 1 to Day 5 of each cycle), every 21 days. This decision should be made prior to registration by the treating physician; switching from capecitabine to 5-FU, or vice versa, will not be allowed during the study. 5-FU will be administered after completion of the cisplatin infusion.
15991288|NCT02954523|Drug|Dasatinib|oral every day
15991289|NCT02954523|Drug|Osimertinib|oral every day
15991291|NCT02954497|Device|Surgical placement of the Jarvik 2015 VAD|The Jarvik 2015 VAD is a miniaturized, fully implantable, continuous flow left ventricular assist device.
15991292|NCT02954497|Procedure|Surgical Placement of Jarvik 2015 VAD|Surgical Implant of the Jarvik 2015 VAD is a miniaturized, fully implantable, continuous flow left ventricular assist device.
15991293|NCT02954484|Drug|pregabalin|see arm/group description. Lyrica manufacture site: Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany.
15991294|NCT02954484|Drug|Placebo|Placebo capsule containing lactose and MCC (no active ingredients).
15991295|NCT02954484|Drug|Etoricoxib|Etoricoxib 120mg per oral once daily on postoperative days 1,2,3. 'Arcoxia' manufacture site: MSD International GMBH, Singapore
15991296|NCT02954484|Drug|paracetamol|Paracetamol 1g per oral 6hourly on postoperative days 1,2,3. Manufacture site: SM Pharmaceuticals, Malaysia
15991297|NCT02954484|Drug|Morphine|"patient-controlled analgesia intravenous morphine sulphate on postoperative days 1,2,3.
~Manufacture site: Hameln Pharma Plus GMBH, Hameln, Germany"
15991298|NCT02954484|Drug|Ropivacaine|Femoral block with ropivacaine 0.5% 30mls. Ropivacaine manufacture site: AstraZeneva AB, Sweden
15991299|NCT02954458|Drug|TED|0.05 mg/kg SC injection once daily.
15992012|NCT02949544|Other|water immersion|warm water immersion
15991300|NCT02954458|Other|SOC|Standard safety assessments and adjustments in nutritional support.
15991301|NCT02954458|Device|Syringe|Teduglutide will be administered using syringe.
15991302|NCT02954458|Device|Needle|Teduglutide will be administered using needle.
15991303|NCT02954445|Biological|Anti-BCMA-CAR-transduced T cells|The first 3 enrolled patients will receive autologous-derived BCMA-targeted CAR-T cells on day 1, 2 and 3 with respective 10%, 30% and 60% of the total expected dosage after receiving lymphodepleting chemotherapy. If the 3 patients don't display severe toxicity, the next patients enrolled will get infused in 2 days with respective 40% and 60% total dosage.
15991304|NCT02954419|Other|No intervention|No intervention
15991305|NCT02954406|Drug|TAK-659|TAK-659 immediate release tablet
15991306|NCT02954406|Drug|Bendamustine|Bendamustine intravenous infusion
15991307|NCT02954406|Drug|Rituximab|Rituximab intravenous infusion
15991308|NCT02954406|Drug|Gemcitabine|Gemcitabine intravenous infusion
15991309|NCT02954406|Drug|Lenalidomide|Lenalidomide capsule
15991310|NCT02954406|Drug|Ibrutinib|Ibrutinib capsule
15991311|NCT02954393|Procedure|Scaling and root planing|SRP will be performed in four to six appointments lasting approximately 1 h each, using manual curettes (Hu-Friedy, Chicago, IL, USA) and ultrasonic device (Cavitron Select SPC, Dentsply professional, York, PA, USA) under local anesthesia. The deep sites will be scaled throughout the first week and treatment of the entire oral cavity will be completed in 14 days.
15991312|NCT02954393|Drug|Metronidazole active phase|Metronidazole 400 mg thrice a day for 14 days in the active phase of the periodontal treatment (beginning with the first SRP session).
15991313|NCT02954393|Drug|Metronidazole healing phase|Metronidazole 400 mg thrice a day for 14 days in the healing phase of the periodontal treatment (3 months after active phase).
15991314|NCT02954393|Drug|Amoxicillin active phase|Amoxicillin 500 mg thrice a day for 14 days in the active phase of the periodontal treatment (beginning with the first SRP session).
15991315|NCT02954393|Drug|Amoxicillin healing phase|Amoxicillin 500 mg thrice a day for 14 days in the healing phase of the periodontal treatment (3 months after active phase).
15991316|NCT02954393|Drug|Placebos active phase|Amoxicillin and metronidazole placebos thrice a day for 14 days in the active phase (beginning with the first SRP session).
15991317|NCT02954393|Drug|Placebos healing phase|Amoxicillin and metronidazole placebos thrice a day for 14 days in the healing phase (3 months after active phase).
15991318|NCT02954380|Device|Zio|long term continuous monitoring
15991319|NCT02954367|Dietary Supplement|PROTEIN|Immediately (<10 min) after completing each training session (resistance training) participants will consume a beverage containing 20g of meat protein (10g) plus whey (10g) mixed with 200 ml of orange juice and water. On non-training days supplement will be ingested before breakfast.
15991320|NCT02954367|Dietary Supplement|CARBOHYDRATE|Immediately (<10 min) after completing each training session (resistance training), participants will consume a beverage containing about 20g of maltodextrin mixed with 200 ml of orange juice and water. On non-training days supplement will be ingested before breakfast.
15991321|NCT02954354|Drug|Baloxavir Marboxil|2 to4 X 20-mg tablets taken orally
15991322|NCT02954354|Drug|Placebo to Baloxavir Marboxil|2 to4 X 20-mg tablets taken orally
15991323|NCT02954354|Drug|Oseltamivir|75 mg capsules taken orally
15991324|NCT02954354|Drug|Placebo to Oseltamivir|Placebo capsules matching oseltamivir 75 mg capsules
15991325|NCT02954341|Device|CardioMEMS HF System|
15991326|NCT02954328|Device|tDCS|The active tDCS condition will consist of 20 min of continuous stimulation. This amount of stimulation is safe for healthy young and older adults and has been shown to induce acute beneficial changes in cortical excitability and cognitive functions.
15991327|NCT02954315|Other|Almonds|
15991328|NCT02954302|Procedure|PrPD with proximal Roux-en-y gastrojejunal anastomosis|the distal antrum was divided about 1 to 2 cm proximal to the pylorus ring, preserving more than 95% of the stomach. The proximal jejunum was divided approximately 2 to 4 cm distal to the duodeno-jejunal junction. After completion of the resection, the proximal end of the first loop of jejunum was then brought through the transverse mesocolon, and the gastrojejunal anastomosis (GJA) was performed in two layers by using 3-0 PDS sutures and 4-0 silk sutures in an end-to-side fashion. The jejunum was then divided 35 to 40 cm distal to the GJA, and the distal limb was brought separately through the transverse mesocolon to be placed in the duodenal bed for reconstruction of the pancreatojejunal anastomosis (PJA) and hepatojejunal anastomosis (HJA).
15991329|NCT02954302|Procedure|conventional PrPD|After completion of the pancreatojejunal anastomosis (PJA) and hepatojejunal anastomosis (HJA), a hand-sewn, isoperistaltic GJA was performed 25 to 30 cm distal to the HJA in two layers by using 3-0 polydioxanone (PDS) sutures and 4-0 silk sutures.
15991330|NCT02954289|Behavioral|Dietary intervention|"Session 1:The Breakfast Club: ways to increase the healthiness of breakfast and all meals.
~Session 2: Calcium and Vitamin D -Keys to Bone Health
~Session 3: Fruits and Veggies -Your New Best Friends
~Session 4: Let's Talk About Fat
~Session 5: Shopping Therapy
~Session 6: Celebrity Chefs Share Their Secrets"
15991331|NCT02954276|Drug|Omexa Sublingual Sumatriptan tablet|75 mg
15991332|NCT02954276|Drug|Imitrex Oral Product|100 mg
15991333|NCT02954263|Drug|TD-1439|
15991334|NCT02954263|Drug|Placebo|
15991335|NCT02954250|Behavioral|Mindfulness Based Cognitive Therapy|The 8-week MMBCT protocol combines the practice of specific meditation techniques with cognitive therapy principles applicable to anxiety and depression. Each session will cover a meditation practice, as well as a relevant topic for discussion. The initial sessions will introduce general concepts of mindfulness (non-judgemental awareness, being in the moment, fostering curiosity, etc.), which will be expanded to more elaborate notions that are particularly relevant to anxiety, depression and suicidal ideations (recognizing thoughts are not facts, cultivating loving kindness for oneself, improving communication with others, etc.) Participants will be encouraged to practice the mindfulness techniques between sessions, a process that will be reviewed during groups in an ongoing fashion.
15991373|NCT02954003|Device|Endo Bypass System|Subject is implanted with the device for up to 3 years.
15991374|NCT02953990|Behavioral|MOMS Program|
15991375|NCT02953977|Behavioral|Diabetes Prevention Program|An adapted version of the Diabetes Prevention Program will be delivered to intervention participants.
15991450|NCT02953431|Device|CPAP|CPAP will be administered with a CPAP machine
15992013|NCT02949531|Drug|oxygen|
15991336|NCT02954237|Device|AMPLATZER™ Cardiac Plug|The AMPLATZER™ Cardiac Plug is a transcatheter, self-expanding device intended for use in preventing thrombus embolization from the left atrial appendage. The device is constructed from a nitinol mesh and consists of a lobe and a disc connected by a central waist. The device is designed to facilitate occlusion. The lobe has stabilizing wires to improve device placement and retention. The device has threaded screw attachments at each end for connection to the delivery and loading cables. The device has radiopaque markers at each end and at the stabilizing wires. Device Sizes: 16, 18, 20, 22, 24, 26, 28, and 30 mm (lobe diameter) Delivery System: AMPLATZER TorqVue® 45º x 45º (sheath sizes 9, 10, or 13 Fr)
15991338|NCT02954211|Device|repetitive transcranial magnetic stimulation (rTMS)|"rTMS can be given to either the stroke or nonstroke hemisphere. For the nonstroke hemisphere, priming rTMS will be given to the optimal spot at an intensity of 90% of threshold at a frequency of 6 Hz for a 5-s ON period followed by 25-s OFF period. The ON-OFF cycling continues for 10 min. Principal rTMS follows priming and is applied at the same intensity at 1 Hz continuously for 10 minutes. The rationale for 6-Hz priming is to make the 1-Hz principal rTMS more effective. The after-effects of the principal rTMS are inhibition of the underlying neurons in the nonstroke hemisphere, which has a facilitating effect on the stroke hemisphere.
~For the stroke hemisphere, rTMS will involve 6-Hz stimulation at the optimal spot at an intensity of 90% of threshold at a frequency of 6 Hz for a 5-s ON period followed by a 25-s OFF period. The ON-Off cycling continues for 10 minutes. With either form of rTMS, the desired effects of the rTMS are facilitation of the neurons in the stroke hemisphere."
15991339|NCT02954211|Behavioral|Physical therapy|Following the total rTMS treatment and a 3-minute break, physical therapy treatment will commence. The physical therapy treatment will consist of 15 minutes of finger movement tracking training followed by 15 minutes of virtual hand exercises. The tracking involves placing an small device on the weak hand that records finger motion and moving the index finger into finger extension and flexion to track a computer screen cursor as accurately as possible along a target track. The virtual hand exercises involve placing the weak hand in front of a computer with a program that will show a virtual hand and some blocks on a computer screen. The patient will attempt to stack the blocks by doing active hand movements that control the virtual hand. Another virtual hand exercise involves using the thumb and index finger to pluck petals from a virtual flower shown on the screen. There are further exercises like this.
15991340|NCT02954198|Drug|Tacrolimus|goal trough level 5-12ng/mL
15991341|NCT02954198|Drug|Prednisone|goal dose 5mg QD
15991342|NCT02954198|Drug|Mycophenolate mofetil|goal dose 1g BID
15991343|NCT02954198|Drug|Everolimus|goal trough level 3-8ng/mL
15991344|NCT02954185|Other|WellClub|
15991345|NCT02954185|Behavioral|Standard Therapy|
15991346|NCT02954172|Drug|Bevacizumab in Combination With Paclitaxel/Carboplatin|Drug Bevacizumab15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
15991347|NCT02954172|Drug|IBI305 in Combination with Paclitaxel/Carboplatin|Drug IBI305 15mg/kg in combination with Paclitaxel/Carboplatin 6 cycles then maintains at 7.5 mg/kg
15991348|NCT02954159|Drug|Tacrolimus|Oral tacrolimus tablet starting at 0.05mg/kg twice daily, with dose adjustments aiming for serum trough levels of 10-15 ng/ml during the first 2 weeks, and 5-10ng/ml subsequently.
15991349|NCT02954159|Drug|Vedolizumab|Intravenous Vedolizumab 300 mg at week 0, 2 and 6 followed by the same dose every 8 weeks. This drug will be given as per standard of care.
15991350|NCT02954159|Other|Placebo|Patients will be randomized 1:1 in Treatment arm (receive Tacrolimus) and Placebo Arm.
15991351|NCT02954146|Behavioral|Connectd mobile application|Connectd is a mobile application that collects and automatically analyzes input from patients with PTSD/TBI, as well as their families, for clinician review. The app will aggregate patient and family input on current issues, relationship stressors, and situational stressors to better focus (personalize) treatment as well as to more efficiently and accurately understand key factors and root causes. In addition, the app provides informational resources for veterans and family regarding treatment options and mental health supports.
15991352|NCT02954133|Device|Invisalign (7 day)|Patients are are fitted with a ClinCheck plan by Align Technology by the qualified Principal Investigator (PI). Orthodontic treatment procedures carried out per the traditional practices of the PI and dental office. Aligners are switched every 7 days.
15991353|NCT02954133|Device|Invisalign (5 day)|Patients are are fitted with a ClinCheck plan by Align Technology by the qualified Principal Investigator (PI). Orthodontic treatment procedures carried out per the traditional practices of the PI and dental office. Aligners are switched every 5 days.
15991354|NCT02954133|Device|OrthoPulse|Daily 10 minute (5 minutes per arch) OrthoPulse treatments are administered at home.
15991355|NCT02954133|Device|Invisalign (3.5 day)|Patients are are fitted with a ClinCheck plan by Align Technology by the qualified Principal Investigator (PI). Orthodontic treatment procedures carried out per the traditional practices of the PI and dental office. Aligners are switched every 3.5 days.
15991356|NCT02954120|Other|no intervention provided|
15991357|NCT02954107|Other|MRI|
15991358|NCT02954107|Other|24h-EEG + video|
15991359|NCT02954107|Other|Neuropsychological tests|
15991360|NCT02954081|Drug|Phase I: Fumaric acid esters. Phase II: Apremilast|Apremilast
15991361|NCT02954068|Drug|IV Oxytocin + IM placebo|
15991362|NCT02954068|Drug|IM Oxytocin + IV placebo|
15991363|NCT02954055|Drug|Paclitaxel|Arm A
15991364|NCT02954055|Drug|Cyclophosphamide|Arm B
15991365|NCT02954055|Drug|Capecitabine|Arm B
15991366|NCT02954055|Drug|Vinorelbine|Arm B
15991367|NCT02954042|Device|Pelvital probe|Pelvital probe
15991368|NCT02954042|Device|Placebo Probe|Placebo Probe
15991369|NCT02954029|Device|ezClot (hemostasis pad)|ezClot pad uses chitosan, a deacetylated complex carbohydrate derived from the naturally occurring substance chitin, to accelerate blood clotting.
15991370|NCT02954029|Device|BloodSTOP ix pad|BloodSTOP® pad is an etherized and oxidized regenerated cellulose matrix that achieves hemostasis by activating the intrinsic coagulation pathway.
15991371|NCT02954029|Device|Rotary compression device|Rotary compression device consists of a plastic arch and a rotary screw to deliver local pressure by moving the silicone compression pad.
15991372|NCT02954016|Device|ePass|Subject is implanted with the device for up to 3 years.
15991376|NCT02953964|Other|Behavioral: perceptual-based memory encoding training|Participants are trained in the use of perceptual-based memory encoding strategies, inclusive of visual imagery and the method of loci. Visual imagery involves the creation and encoding of mental images, while the method of loci refers to linking these images with specific places to facilitate memory (Simon et al., 2012). Participants are taught to visualise performing each step of a task in a familiar environment, such as in their home (Liu et al., 2009). After participants can correctly visualise the entire task, they then progress to actually performing the task. During the intervention sessions, 2-3 tasks are covered each session, and these tasks become progressively difficult as the weeks progress. The intervention lasts for 10 weeks with one session every week. Each session runs for 90 minutes. A follow-up home training program is run once a week for 30 minutes with the participant and their care-giver.
15991377|NCT02953964|Other|Behavioral: semantic-based memory encoding training|Participants are asked to encode the steps of a task by forming an association of the steps and sequence. Participants are trained in the use of the chunking association method and honeycomb concept and perform different tasks each week, implementing this encoding strategy (Lim et al., 2012). The chunking association method breaks down information into smaller parts and helps with the encoding and retrieval of information. The honeycomb concept allows the steps to form a story in relation to place, time, characters, problem and solution and the story is verbalised. Participants then complete the task. During the intervention sessions, 2-3 tasks are covered each session, and these tasks become progressively difficult as the weeks progress. The intervention lasts for 10 weeks with one session every week. Each session runs for 90 minutes. A follow-up home training program is run once a week for 30 minutes with the participant and their care-giver.
15991378|NCT02953964|Other|Behavioral: Cognitive stimulation group (control group)|Participants receiving cognitive stimulation intervention. It consists of eight sessions that train participants' visual attention and memory, auditory attention and memory and their application in daily activities. Two sessions are also given which allow for participants to apply the training practically in their daily lives. The intervention lasts for 10 weeks with one session every week. Each session runs for 90 minutes. A follow-up home training program is run once a week for 30 minutes with the participant and their care-giver.
15991379|NCT02953951|Other|blood transfusion|blood transfusion different sources
15991380|NCT02953938|Biological|Ranibizumab|"Ranibizumab is a biologic and known anti-VEGF (vascular endothelial growth factor) medication approved for treatment of ME (Macular Edema) due to RVO (Retinal Vein occlusion)
~0.5 mg ranibizumab applied one + PRN as intravitreal injection of 0.05 mL, with or without laser treatment"
15991381|NCT02953938|Radiation|Grid&Direct short pulse laser photocoagulation|Grid&Direct short pulse laser photocoagulation is a kind of laser treatment to retina within vascular arcades and used to suppress macular edema
15991382|NCT02953912|Procedure|Reciproc single-file|The Reciproc is a single-file nickel-titanium systems , made of a special nickel-titanium (NiTi) alloy called M-Wire created by innovated thermal treatment process which increases flexibility and improved resistance to cyclic fatigue
15991383|NCT02953912|Procedure|One Shape single-file|One Shape is one of the few single file made of austenite 55- NiTi alloy characterized by different cross sectional designs ,it is used in continuous clockwise rotation for a quick and safe root canal preparation due to its flexibility and minimal fatigue.In addition to , the electropolished safety tip instrument for enhanced cutting efficiency and it is delivered in a sterile blister for single use.
15991384|NCT02953899|Behavioral|Contingency Management|In addition to Cognitive Behavioural Therapy, this intervention uses small incentives to reinforce study attendance and gambling abstinence.
15991385|NCT02953899|Behavioral|Cognitive Behavioural Therapy|This intervention uses psychoeducation, behavioural strategies, and cognitive restructuring to assist the participant in their efforts to become abstinent from gambling.
15991386|NCT02953886|Device|Silver Diamine Fluoride (SDF)|No caries removal will take place. Bacterial samples will be collected using Gracey curettes at the initial visit before application of SDF and one month after. The tooth will be dried and SDF will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet
15991387|NCT02953873|Drug|Tacrolimus Extended Release Capsule|goal trough 5 - 12ng/mL
15991388|NCT02953873|Drug|Mycophenolate mofetil|≥500mg twice a day
15991389|NCT02953873|Drug|Prednisone|goal dose 5mg daily
15991390|NCT02953873|Drug|Mycophenolate Sodium|≥360mg twice a day
15991391|NCT02953860|Drug|Fulvestrant with Enzalutamide|500mg of Fulvestrant will be given IM on days 1, 15, 28, then every 4 weeks as per standard of care (SOC) and 160mg of Enzalutamide will be given PO daily. Patients will receive a tumor biopsy at the start of treatment and 4 weeks after the start of treatment, with an optional 3rd biopsy at the end treatment.
15991392|NCT02953847|Drug|Rimactane|150 mg capsules, Sandoz MCC registration # A/20.2.3/784
15991393|NCT02953847|Drug|Rifafour e-275|Rifampicin/isoniazid/pyrazinamide/ethambutol 150/75/400/275 mg This 4-drug FDC is the most widely used 4-drug FDC in South Africa with an estimated 100% of the SA DOH tender.
15991394|NCT02953847|Drug|Rimactazid 150/75|Rifampicin/isoniazid 150/75 mg This 2-drug FDC is one of 2 widely used 2-drug FDCs in South Africa, with an estimated 30% of the SA DOH tender. Rifinah® made by Sanofi-Aventis holds about 70% of the tender, however as the Sanofi-Aventis 4-drug FDC will also be evaluated.
15991395|NCT02953834|Drug|kisspeptin 112-121|Dose: 0.313-12.5 mcg/kg Duration: up to 16 hours
15991396|NCT02953834|Other|Insulin Resistance Test|Eat or drink a standard meal OR drink a standard drink containing 75 grams of sugar
15991397|NCT02953834|Other|Placebo|Receive intravenous fluids for up to 16 hours that do not contain any study drug
15991398|NCT02953821|Drug|Acthar Gel|1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)
15991399|NCT02953821|Drug|Placebo Gel|1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)
15991400|NCT02953808|Drug|Placebo|0.9% weight by volume (w/v) saline solution for intravenous infusion over 1 hour (in Cohort 1) or over 15 hours (in Cohort 2).
15991401|NCT02953808|Drug|GSK2315698|200 mg/mL stock solution for intravenous infusion over 1 hour (in Cohort 1) or over 15 hours (in Cohort 2). The stock solution will be diluted to obtain dosage levels of 10 mg/hr, 20 mg/hr, or 40 mg/hr.
15991402|NCT02953782|Drug|Magrolimab|Administered intravenously
15991403|NCT02953782|Drug|Cetuximab|Administered intravenously
15991448|NCT02953444|Other|Thirty-Second Mindfulness Practice|
15991449|NCT02953444|Other|Three-Minute Mindfulness Practice|
15991404|NCT02953756|Radiation|Gamma Knife radiosurgery|Gamma Knife radiosurgery will be performed with a Leksell Gamma Knife® Icon, Elekta Instruments, AB. Depending upon the tumor volume, a dose of 18-25 Gy will be prescribed with 99-100% coverage of the target
15991405|NCT02953743|Drug|Lenvatinib|Lenvatinib 4 mg capsules will be administered orally, once daily continuously 28-day cycles until disease progression, development of unacceptable toxicity or withdrawal of consent.
15991406|NCT02953730|Drug|PEG-rhG-CSF|
15991407|NCT02953717|Radiation|Gamma Knife radiosurgery|GKRS is performed with a Leksell Gamma Knife® Icon, Elekta Instruments, AB. Depending upon the volume, a dose of 18-25 Gy will be prescribed with 99-100% coverage of the target.
15991408|NCT02953717|Radiation|Whole Brain Radiation Therapy|Patients in the WBRT group will receive 4 Gy x 5 fractions (total of 20 Gy) in one week, which is a commonly utilized treatment schedule according to Dutch guidelines.
15991409|NCT02953691|Drug|Galacto-Oligosaccharide|Mixture produced from lactose utilizing the transgalactosidic activity of Bifidobacterium bifidum NCIMB 41171 beta-galactosidase
15991410|NCT02953691|Drug|Maltodextrin (Placebo)|Maltodextrin is a polysaccharide commonly used as a food additive. It is produced from starch by partial hydrolysis.
15991411|NCT02953678|Drug|Ruxolitinib|
15991412|NCT02953678|Drug|Prednisone or methylprednisolone|Either oral prednisone or IV methylprednisolone may be used to begin corticosteroid treatment at the investigator's discretion.
15991415|NCT02953652|Drug|HBI-8000|Orally twice weekly
15991416|NCT02953639|Drug|Basmisanil|Participants received either 80 milligrams (mg) or 240 mg of Basmisanil, as per the dosing schedules described above.
15991417|NCT02953639|Drug|Placebo|Participants received matching Placebo to Basmisanil, as per the dosing schedules described above.
15991418|NCT02953626|Behavioral|Mother Matters Online Postpartum Support Group|"Mother Matters is a 10-week online support group for women with postpartum depression. It involves: 1) A private, online forum that can be accessed by participants 24-hours per day. During regular business hours (9:00 am to 5:00 pm on weekdays) it is moderated by a psychotherapist, and there is a weekly moderated live chat hour; 2) Weekly topics with readings are provided with questions to prompt discussion on the online forum. Topics incorporate symptom management (i.e. Interpersonal Therapy, Cognitive Behavioural Therapy) and affect regulation strategies (i.e. Mindfulness, DBT) with a supportive counselling approach. External resources related to each week's topic, are also shared."
15991419|NCT02953613|Device|NIRS/IVUS|Cardiac catheterization using infraredx
15991420|NCT02953600|Dietary Supplement|Standard Dose Spirulina Platensis|As previous small scale of clinical trial results in HBV patients provided by Far East Bio-Tec Company, lamivudine combined with oral Spirulina platensis would also improve the sero-conversion rates of HBeAg.
15991421|NCT02953600|Other|Zero Spirulina Platensis|the zero pill-taken group is a comparison for two other groups.
15991422|NCT02953600|Dietary Supplement|Double Dose Spirulina Platensis|As previous small scale of clinical trial results in HBV patients provided by Far East Bio-Tec Company, lamivudine combined with oral Spirulina platensis would also improve the sero-conversion rates of HBeAg. Hence, the investigators would like to see if the investigators could improve sero-conversion rates much faster by taking double dose of Spirulina platensis.
15991423|NCT02953587|Procedure|Oral Glucose Tolerance Test (OGTT)|Subjects will have glucose administered enterally and blood will be drawn to measure its kinetics.
15991424|NCT02953587|Drug|Human Ghrelin|Human ghrelin will be administered by IV at two of the four study visits in conjunction with the OGTT.
15991425|NCT02953587|Drug|Saline|Saline Infusion will be administered by IV at two of the four study visits in conjunction with the OGTT to serve as a placebo comparator for the human ghrelin infusions.
15991426|NCT02953574|Procedure|daily sleep enhancement nursing protocol|
15991427|NCT02953561|Drug|Avelumab|Given IV
15991428|NCT02953561|Drug|Azacitidine|Given SC or IV
15991429|NCT02953561|Other|Laboratory Biomarker Analysis|Correlative studies
15991430|NCT02953548|Drug|GWP42003-P|Clear, colorless to yellow solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
15991431|NCT02953535|Drug|Magicbuvir|1 tablet contains 400 mg sofosbuvir
15991432|NCT02953535|Drug|Sovaldi (fist dose)|1 tablet contains 400 mg sofosbuvir
15991433|NCT02953535|Drug|Sovaldi (second dose)|1 tablet contains 400 mg sofosbuvir
15991434|NCT02953522|Other|191 mcg/day of Folate|Diet containing 191 mcg / day of Folate
15991435|NCT02953522|Other|90 mcg / day of Folate|Diet containing 90 mcg / day of Folate
15991440|NCT02953496|Drug|vonapanitase|Vonapanitase will be administered to the target lesion of the SFA or PA via percutaneous needle injection under ultrasound guidance.
15991441|NCT02953483|Other|Red blood cells|Packed red blood cells to final hematocrit of 14%
15991442|NCT02953470|Behavioral|Individual tailored functional exercise|Receive individual tailored exercise to increase ability to perform everyday activities through increased physical function and self-efficacy in relation to be able to exercise and decreased pain-related beliefs such as fear of falling, catastrophizing thoughts and fear of movement.
15991443|NCT02953470|Behavioral|Standard care|Receives written and oral advice about physical Activity and the benefits of being physically active by one visits from a physiotherapist. Than will the participants receive Telephone reminder about following the advice once a week during intervention week 1-8 and 10.
15991444|NCT02953457|Biological|Durvalumab|Given IV
15991445|NCT02953457|Other|Laboratory Biomarker Analysis|Correlative studies
15991446|NCT02953457|Drug|Olaparib|Given PO
15991447|NCT02953457|Biological|Tremelimumab|Given IV
15995030|NCT02927184|Drug|Placebo|
15991453|NCT02953392|Device|Anorganic Bovine Bone Graft Material|Anorganic bovine bone graft material is intended for augmentation or reconstructive treatment of the alveolar ridge, filling periodontal defects, filling defects after root resection, apicoectomy, and cystectomy, filling extraction sockets to enhance preservation of the alveolar ridge, and elevation of maxillary sinus floor.
15991454|NCT02953392|Device|Collagen Membrane|Collagen dental wound dressing is intended for the management of oral wounds and sores, including; dental sores, oral ulcers, periodontal surgical wounds, suture sites, burns, extraction sites, surgical wounds, and traumatic wounds.
15991455|NCT02953392|Device|Shelta Platform Switching Premium Implants|Shelta implant systems are intended for immediate placement and function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.
15991456|NCT02953392|Device|Shelta Platform Matching Premium Implants|Shelta implant systems are intended for immediate placement and function on single tooth and /or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.
15991457|NCT02953379|Drug|EMS Mometasone gel|The patient should administer 2 spray in each nostril, once daily.
15991458|NCT02953379|Drug|Mometasone spray nasal|The patient should administer 2 spray in each nostril, once daily.
15991459|NCT02953366|Drug|EMS Mometasone gel|The patient should administer 1 spray in each nostril once daily.
15991460|NCT02953366|Drug|Mometasone spray nasal|The patient should administer 1 spray in each nostril once daily.
15991461|NCT02953353|Device|Active transcranial direct current stimulation (tDCS)|Participants will receive 10 daily sessions (phase 2) and 3 times a week (phase 3) of tDCS (2mA, 30 min per session). The tDCS montage will target the left dorsolateral prefrontal cortex (DLPFC) (anode: F3 based on the 10:20 system; cathode over the right supraorbital area). For stimulation the investigators will use 5x5cm sponge pads that will be soaked in 0.9% saline during the sessions.
15991462|NCT02953353|Other|Hypocaloric diet|During phase 3, participants will undergo a supervised hypocaloric diet intervention for 2 weeks based on a low-calorie diet (LCD) providing a hypocaloric diet based in 20% reduction from total energy expenditure (TEE). The diet will be individualized on the basis of physical activity levels, age for each participant. This intervention will be be conducted at an inpatient, well-controlled setting to guarantee adherence to the diet. Here the diet intervention will be administered in combination with tDCS. tDCS will be applied every other day (Monday, Wednesday, Friday) over the course of these two weeks.
15991463|NCT02953353|Other|Sham transcranial direct current stimulation (tDCS)|Subjects in the control group will receive sham stimulation (placebo) (similar procedure and duration as real tDCS, but here electric current flows for 30 s only, to mimic the subjective sensations that occur with active tDCS).
15991464|NCT02953340|Drug|SPI-2012|Supplied in prefilled single-use syringes for subcutaneous injection, administered on Day 2 of each cycle
15991465|NCT02953340|Drug|Pegfilgrastim|Subcutaneous injection administered on Day 2 of each cycle.
15991466|NCT02953340|Drug|Docetaxel|75mg/m^2 IV infusion administered on Day 1 of each cycle
15991467|NCT02953340|Drug|Cyclophosphamide|600mg/m^2 IV infusion administered on Day 1 of each cycle
15991468|NCT02953327|Biological|Bacille Calmette-Guerin|Vaccine against tuberculosis
15991469|NCT02953327|Biological|BCG solvent|Simple solvent
15991470|NCT02953314|Drug|TEZ|
15991471|NCT02953314|Drug|TEZ/IVA|
15991472|NCT02953314|Drug|IVA|
15991473|NCT02953301|Drug|resminostat|
15991474|NCT02953301|Drug|Placebo|
15991475|NCT02953275|Drug|vedolizumab|standard of care
15991476|NCT02953275|Drug|Pentoxifylline|added to vedolizumab
15991477|NCT02953275|Drug|placebo|added to vedolizumab
15991478|NCT02953262|Behavioral|My HealtheVet Brochure|Participants will receive a mailed brochure with basic My HealtheVet content.
15991479|NCT02953262|Behavioral|My HealtheVet Training Guide for Veterans Living with Diabetes|Participants will be mailed a bound My HealtheVet training guide with step by step instructions on how to register, upgrade to Premium account, refill prescriptions, use secure messaging, download their Blue Button reports, and other features
15991480|NCT02953262|Behavioral|My HealtheVet Group Training|Participants will be invited to participate in a scheduled group training to learn how to use My HealtheVet to help manage their diabetes
15991481|NCT02953262|Behavioral|My HealtheVet Individual Training|Participants will be invited to participate in a one-on-one training to learn how to use My HealtheVet to help manage their diabetes at a time of their convenience.
15991482|NCT02953236|Procedure|Instrumented massage|The first group will receive a 20 min session of instrumented massage on back and neck areas. Subjects will be in prone position and physical therapist will applied instrumental massage in a protocolised way from low back until neck muscles, both in left and right side of the body.
15991483|NCT02953236|Procedure|Manual massage|The second group will receive a 20 min session of manual massage on back and neck areas. Subjects will be in prone position and physical therapist will applied manual massage in a protocolised way from low back until neck muscles, both in left and right side of the body.
15991484|NCT02953223|Other|Free amino acid infant formula|Patients who will be fed a free amino acid based infant formula
15991485|NCT02953210|Drug|dexter ketamine|multimodal anesthesia without opioids ketamine as induction drug
15991486|NCT02953210|Drug|Lidocaine Hydrochloride|continuous infusion intravenous
15991487|NCT02953210|Drug|Fentanyl Hydrochloride|intravenous
15991488|NCT02953210|Drug|Clonidine Hydrochloride|clonidine intravenous pre induction
15991489|NCT02953210|Drug|Midazolam Hydrochloride|premedication
15991490|NCT02953210|Drug|Isoflurane Volatile Liquid|maintenance of general anesthesia
15991491|NCT02953210|Drug|Rocuronium Injectable Solution|induction of general anesthesia
15991492|NCT02953210|Drug|Propofol 1 % Injectable Suspension|induction of general anesthesia
15991493|NCT02953210|Drug|Dexamethasone-21-Sulfobenzoate, Sodium Salt|at the end of the procedure 4mg IV
15991494|NCT02953210|Drug|Ranitidine Hydrochloride|at the end of the procedure
15991495|NCT02953210|Drug|Ondansetron Hydrochloride|at the end of the procedure
15991496|NCT02953210|Drug|Ketorolac Injectable Solution|at the of the procedure
15991497|NCT02953210|Drug|Bupivacaine Hydrochloride|at the end of the procedure for infiltration of trocar wounds
15991498|NCT02953197|Radiation|FDG-PET guided radiation dose escalation|Selective dose escalation
15991499|NCT02953184|Drug|Pegylated Liposomal Doxorubicin|35mg/m2 iv drop during the first 4 cycles every three week
15991500|NCT02953184|Drug|Cyclophosphamide|600mg/m2 IV drop during the first 4 cycles every three week
15991501|NCT02953184|Drug|Taxotere|100mg/m2 IV drop during the last 4 cycles every three week
15991502|NCT02953184|Drug|Dexrazoxane (DZR)|DZR will be administrated for protecting Cardiac toxicity in the group of Active comparator.
15991503|NCT02953184|Drug|vitamin B|Vitamin B will be administrated for protecting HFS in PLD group
15991504|NCT02953184|Drug|Doxorubicin|60mg/m2 Doxorubicin IV drop during the first 4 cycles every three week
15991505|NCT02953184|Procedure|Breast Conserved Surgery|Patients will undergo Breast Conserved Surgery if the tumor/breast ratio is proper and she demands to conserve the breast after 8 cycles of chemotherapy
15991506|NCT02953184|Procedure|Modified Radical Mastectomy|Patients will undergo Modified Radical Mastectomy if she does not keep her breast after 8 cycles of chemotherapy
15991507|NCT02953184|Procedure|Sentinel Lymph Node Biopsy（SLNB）|Patients will undergo Sentinel Lymph Node Biopsy（SLNB） if the evaluation of lymph node are negative after 8 cycles of chemotherapy
15991508|NCT02953171|Other|Raw, lacto-fermented sauerkraut|Sauerkraut fermentations have been shown to contain a broad range of microorganisms, including Leuconostoc mesenteroides, Lactobacillus plantarum, Leuconostoc citreum, Leuconostoc argentinum, Lactobacillus paraplantarum, and Lactobacillus coryniformis. Some of these bacteria, such as Lactobacillus plantarum, are classified as probiotics.
15991509|NCT02953171|Dietary Supplement|Mutaflor|The probiotic Escherichia coli Nissle 1917, registered in Germany as the medicinal product Mutaflor, possesses a unique combination of fitness and survival factors.
15991510|NCT02953171|Other|Pasteurized sauerkraut|Sauerkraut without live bacteria.
15991511|NCT02953171|Other|Placebo capsule|Capsules without probiotics
15991512|NCT02953158|Other|Haas Avocado|Hypocaloric weight loss diet
15991513|NCT02953158|Behavioral|Dietary Counseling|Dietary Counseling
15991514|NCT02953145|Drug|Tisseel|Tisseel will be applied to open areas lateral to the cleft palate repair
15991515|NCT02953132|Drug|MT-4129|
15991516|NCT02953132|Drug|Placebo|
15991517|NCT02953119|Other|Prehabilitation|
15991518|NCT02953106|Drug|Azelastine-Fluticasone Nasal|137 micrograms azelastine hydrochloride / 50 micrograms fluticasone propionate
15991519|NCT02953106|Drug|Placebos|Placebo nasal spray
15991520|NCT02953093|Drug|Acarbose|see arm description
15991521|NCT02953093|Other|Placebo|See arm description
15991522|NCT02953080|Other|Call for life mHealth adherence support|Daily/ weekly pill reminder support Health Info-tips Appointment visit reminders Self-reported symptom support
15991523|NCT02953067|Procedure|Open reduction and internal fixation|Stratum 1: Conservative treatment versus open reduction and internal fixation Stratum 2: Open reduction and internal fixation versus arthrodesis
15991524|NCT02953067|Procedure|Primary arthrodesis|Primary arthrodesis versus ORIF
15991525|NCT02953067|Procedure|Conservative treatment|Conservative treatment versus open reduction and internal fixation
15991526|NCT02953054|Drug|DMTS|DMTS applied before surgery and worn for 72 hours
15991527|NCT02953054|Drug|Placebo|Matching patches that have no active drug applied before surgery and worn for 72 hours.
15991528|NCT02953041|Drug|Glycopyrronium|long-acting muscarinic antagonist
15991529|NCT02953041|Drug|Indacaterol|ultra long-acting beta agonist
15991530|NCT02953028|Device|CPAP|Auto-CPAP-machine for treating Obstructive Sleep Apnea With positive airway pressure
15991531|NCT02953028|Device|Mandibular Advancing Splint|Oral Appliance for providing an open upper airway as a mean of treating Obstructive Sleep Apnea
15991532|NCT02953015|Behavioral|Manipulative articulatory (ART) and myofascial techniques|Three manipulative articulatory (ART) and myofascial techniques will be performed to improve cervical and thoracic spine joint mobility and reducing soft tissue stiffness in the cervico-thoracic spine. ART technique is a low velocity to high amplitude technique where each joint is carried through its full motion to increase range of movement. The activating force is either a repetitive springing motion or repetitive concentric movement of the joint through the restrictive barrier. Myofascial technique is directed at the muscle and fascia treatment. It engages continual palpatory feedback to achieve release of myofascial tissues. During each treatment session, each technique will be carried out for 10 minutes including 2 minutes of resting.
15991533|NCT02953015|Device|Transcutaneous Electrical Nerve Stimulation|Transcutaneous Electrical Nerve Stimulation (TENS) of the upper trapezius muscle will be applied by a portable machine Master 932 (Elettronica Pagani SRL, Milan, Italy) that generates symmetric, bi-phasic rectangular pulses with 140μ sec duration. The current frequency will be set at 150 Hz and intensity will be increased up to patient's perception of paresthesia. The negative electrode will be placed on the active TrPs of the upper trapezius muscle and the positive one was on acromial tendon insertional site. The total duration of each application will be 20 minutes. Treatment frequency and duration will be the same of the EG treatment (1 session/week for 4 weeks). Each session will consist of 20 min of TENS and 10 min of resting in sitting position with the head lean on a pillow.
15991534|NCT02953015|Drug|OnabotulinumtoxinA (Prophylaxis therapy)|Prophylaxis therapy with OnabotulinumtoxinA according to the PREEMPT protocol (155U every three months into 31 injection site).
15991535|NCT02953002|Device|Calibrated Automated Thrombogram (CAT)|The Calibrated Automated Thrombogram (CAT). Thrombogram describes the concentration of thrombin in clotting plasma and is therefore a general physiologic function test of the thrombotic hemostatic system. The CAT measures thrombotic as well as bleeding tendency.
15991536|NCT02952989|Drug|SGN-2FF|SGN-2FF oral daily dosing.
15991537|NCT02952989|Drug|pembrolizumab|200 mg every 3 weeks by IV infusion
15991538|NCT02952976|Device|Abthera|ABThera group technique the dressing will be done according to the description and the manufacturer's instructions (Acelity, San Antonio, TX).
15991539|NCT02952976|Device|Barker|In Barker Group a fenestrated plastic will be used and that will be in contact with viscera followed by four pads with a suction drain and an adhesive finishing layer.
15991540|NCT02952963|Drug|Chenodeoxycholic Acid|
15991541|NCT02952963|Drug|Colesevelam|
15992162|NCT02948283|Drug|Metformin Hydrochloride|Given PO
15991542|NCT02952950|Other|Oralstimulation|The intervention group granted in total 1 hour instructions in a program of oral stimulation by one of two occupational therapists with experience in oral stimulation of preterm infants. The first guidance for parents has duration of approximately half an hour and then follow-up once or twice, depending on the needs of the family. To maintain consistent intervention over time is the program of oral stimulation written in a script, where the family also must record the following variables: date and time of oral stimulation. In occupational therapy the guidance and in the script examines the signs that the infant exhibits when it is ready / not ready for stimulation. The family also sees a movie where these signs and the program of oral stimulation review auditory and visual.
15991543|NCT02952937|Drug|GLA5PR GLARS-NF3 tablet 300mg|A new formulation(3rd.) of Pregabalin CR tablet
15991544|NCT02952937|Drug|GLA5PR GLARS-NF1 tablet 300mg|A new formulation(1st.) of Pregabalin CR tablet
15991545|NCT02952924|Drug|Midazolam|Single dose of 100 mcg midazolam solution will be administered orally, before (Day -1) and after (Day 14) the treatment with RO7049389 or matching placebo
15991546|NCT02952924|Other|Placebo|Placebo matching to RO7049389 will be administered as per schedule described in individual arm.
15991547|NCT02952924|Drug|RO7049389|RO7049389 will be administered as per schedule described in individual arm.
15991548|NCT02952911|Device|Smartphone and Smartwatch|Multiple sclerosis participants and healthy controls are required to wear the smartwatch; and to carry smartphone preferably in a median position in a belt bag, or alternatively in their pocket as they go about their daily routine.
15991549|NCT02952898|Drug|GDC 695|GDC 695 is a topical gel.
15991550|NCT02952898|Drug|Diclofenac Sodium Gel, 3%|Diclofenac sodium gel, 3% is an FDA-approved drug.
15991551|NCT02952898|Drug|Vehicle gel|Vehicle topical gel contains 0.0% of active drug and is color matched to the other two active test drugs.
15991552|NCT02952885|Drug|Pegvisomant|Study medications will be prescribed as per clinical practice with PEGV being added, or optimally dosed, at the Month 0 visit. Subjects who are naïve to PEGV should start their injections from 10 mg twice a week to 10 mg daily if used as combination therapy or 10 to 20 mg daily if used as monotherapy. Maximum dosing should not exceed 40mg/day. Dosing of PEGV can be adjusted as per clinical judgement to meet the normalization of IGF-1 levels (<1.0 ULN) in increments of 5-10mg/day. In the event of a reduction in IGF-1 below the LLN, the dose of PEGV could be decreased by 5-10 mg/day.
15991553|NCT02952872|Behavioral|Brief Tablet-based Intervention to Address Heavy Alcohol Use|The intervention will be be tablet-based and take approximately 20 minutes to complete. Content will focus on heavy alcohol use.
15991554|NCT02952859|Other|Irreversible electroporation|
15991555|NCT02952846|Other|Algorithm for tapering og analgosedation|Algorithm for tapering og analgosedation
15991556|NCT02952833|Drug|Saline|Sodium chloride solution.
15991557|NCT02952833|Biological|Zika Virus Purified Inactivated Vaccine (ZPIV)|Zika Virus Purified Inactivated Vaccine with aluminum hydroxide adjuvant.
15991558|NCT02952820|Drug|lemborexant|
15991559|NCT02952820|Drug|Placebo|
15991560|NCT02952807|Drug|Misoprostol|vaginal Misoprostol Plus Foley Catheter
15991561|NCT02952807|Device|Foley Catheter|
15991562|NCT02952794|Procedure|endoscopic submucosal dissection (ESD) and endoscopic mucosal band ligation (EMBL) for early cancer|
15991563|NCT02952781|Device|EKG Patch monitors (Zio and Carnation)|Each patient will be provided with both a Zio-XT Patch monitoring system and the CAM system and will be instructed to wear both simultaneously for 7 days.
15991564|NCT02952768|Behavioral|ultrasound training|Through the ultrasound-circulation-airway-breathing training curriculum to integrate the ultrasound into clinical practice.
15991565|NCT02952755|Drug|Co-administration of DWC20155/DWC20156|
15991566|NCT02952755|Drug|DWC20162|
15991567|NCT02952742|Drug|Black Cohosh|Vital Nutrients Black Cohosh Extract
15991568|NCT02952742|Other|Placebo|Inactive comparator resembling the Black Cohosh formulation in appearance. Ingredients include: cellulose; caramel color; powdered yellow dye; and powdered red dye.
15991569|NCT02952729|Drug|XMT-1522|one intravenous dose administered in-clinic every 21 days
15991570|NCT02952716|Biological|Human cord blood mononuclear cell|The patients were treated by human cord blood mononuclear cell through subarachnoid space
15991571|NCT02952716|Other|hyperbaric oxygen|The patients were treated by hyperbaric oxygen
15991572|NCT02952703|Behavioral|brief pre-delivery smoking cessation counseling|
15991573|NCT02952703|Behavioral|additional pre-delivery smoking cessation counseling|
15991574|NCT02952703|Behavioral|post- delivery smoking cessation counseling|
15991575|NCT02952703|Behavioral|incentives|
15991576|NCT02952690|Device|Glidescope® with tip manipulated stylet|The intubating style is curved in accordance with the curve of GVL blade and the distal tip of style is additionally bended to the left (15-20 degree)
15991577|NCT02952690|Device|Glidescope® with standard-curved tip|The style is curved in accordance with the curve of GVL blade
15991578|NCT02952677|Behavioral|Remind-to-move|Participants were required to wear sensory cueing wristwatch devices with vibration emitted on the affected arm for 3 consecutive hours daily, for a total of 4 weeks, at any time during the day, and received usual care as well.
15991579|NCT02952677|Behavioral|Sham|Participants were required to wear sensory cueing wristwatch devices without vibration emitted on the affected arm for 3 consecutive hours daily, for a total of 4 weeks, at any time during the day, and received usual care as well.
15991580|NCT02952677|Other|Control|Participants received usual care
15991581|NCT02952664|Behavioral|PUMP Monitoring|A video camera will be placed in each subject room for recording the repositioning events to correlate the monitor signals with the actual subject repositioning captured by the video.
15991582|NCT02952651|Procedure|Pulse oximeter|When there are clinical signs of hypovolemia, such as hypotension, decreased urine output and central venous pressure less than 5 mmHg, POP waveforms are obtained from each index finger, which pulse oximeter sensor is applied by increasing contact force (from 0 to 1.4N, being increased by 0.2-0.3N). Then intravenous crystalloid 10 mL/kg is infused for 15 min.
15991583|NCT02952625|Other|Imaging|Single arm Imaging (PET/MR) study
15991584|NCT02952599|Drug|Edoxaban|Prescribed according to approved label
15991585|NCT02952586|Drug|Avelumab|Avelumab + SOC Chemoradiation
15991586|NCT02952586|Other|Chemoradiation|Cisplatin + Radiation Therapy
15991588|NCT02952573|Drug|Dexamethasone|Cycle 1 and 2: OD dosing on days 1-4, 9-12, and 17-20;Cycle 3: OD dosing on days 1, 8, 15, 22
15991589|NCT02952560|Other|Ultrasound scan|Ultrasound scanning examinations will be performed twice (pre-CT scan and post CT-scan). Each examination will be performed by two observers who are blinded to each other's measured values.Patients will be asked to place a small sip of water (20 mL)in their mouth and keep the mouth open during the imaging. A second ultrasound examination of each patient by the two observers will be performed after the CT-scan.
15991590|NCT02952547|Drug|Co-administration of DWC20155 and DWC20156|
15991591|NCT02952547|Drug|DWJ1366 Tab.|
15991592|NCT02952534|Drug|Rucaparib|Rucaparib will be administered daily
15991593|NCT02952521|Procedure|Blood Draw|CA125 and ctDNA
15991594|NCT02952521|Procedure|Tumor Tissue Biopsy|Only collected at time of surgery if patient undergoes surgical debulking
15991595|NCT02952508|Drug|CLR 131 single dose|Radiopharmaceutical
15991596|NCT02952508|Drug|CLR 131 multiple dose|Radiopharmaceutical
15991597|NCT02952508|Drug|CLR 131 fractionated dose|Radiopharmaceutical
15991598|NCT02952495|Behavioral|Online alcohol educational class|"Participants will be asked to review an online alcohol education class. This is a web-based patient educational program designed to prevent hazardous and harmful drinking in older adults. The project's specific objectives are to 1) provide reliable information on the extent to which A Toast to Health in Later Life! reduces alcohol-related risks and problems among older patients who drink and 2) evaluate the extent to which these reductions are associated with increases in health-related quality of life, patient knowledge and self-efficacy and decreases in the use of health services and the costs of care."
15991599|NCT02952482|Procedure|newborns testing for ALD|Routine newborn screening dried blood spots sample is used to test if elevation of C26:0-lyso-PC
15991600|NCT02952469|Drug|(68Ga)PSMA-HBED-CC|Experimental radiotracer for imaging prostate cancer
15991601|NCT02952456|Other|interview with a psychologist|interview with a psychologist in Bereaved families, Patients with épilepsy and relatives of patients with epilepsy Relatives (Parents / spouse/ Husband) of patients with epilepsy
15991602|NCT02952443|Behavioral|Exercise|Participants will be randomized, using a table of random numbers, to either an Exercise (EX) or a Control (CON) group. The EX group will participate in a 16-week multi-component training intervention (3x per week, 45 to 60 minutes/session, at moderate to vigorous intensity) that will include primarily resistance exercises, an aerobic warm-up and cool down, and include both flexibility and balance exercises throughout the session (Bray et al., 2016).
15991603|NCT02952443|Behavioral|Control|The CON group will be asked to maintain their normal daily living habits for the same duration (16 weeks). At the conclusion of the 16-weeks the exercise program will be made available to the CON group.
15991604|NCT02952430|Procedure|Emergency laparotomy|Patients already undergoing emergency laparotomy - groups divided pre-operatively into frail and not frail based on modified Rockwood score. Then outcomes observed.
15991605|NCT02952417|Other|Excess mortality|Relative survival was defined as the observed survival among patients with STEMI and NSTEMI divided by the expected survival in the age, sex and year matched populace of Sweden.
15991606|NCT02952404|Procedure|Educational workshop|The educational workshop for improved perineal support during vaginal delivery
15991607|NCT02952391|Other|[18F] FEOBV PET scan|Cholinergic PET scan with the tracer [18F]Fluoroethoxybenzovesamicol
15991608|NCT02952378|Drug|Albumins|Infusion of 3ml/kg bodyweight of hyperoncotic albumin 20% during 30 minutes.
15991609|NCT02952365|Drug|Tissue sealant|Application of tissue sealant on eyes undergoing LASIK enhancement
15991610|NCT02952352|Behavioral|Diabetes Prevention Program|Culturally adapted diabetes prevention program
15991611|NCT02952339|Biological|RSV LID ΔM2-2 1030s vaccine|10^5.0 PFU; administered as nose drops
15991612|NCT02952339|Biological|Placebo|Administered as nose drops
15991613|NCT02952326|Procedure|XP Endo Finsher as final step of the irrigation protocol|The canals will be thoroughly irrigated using 3ml syringe of 2.5% Sodium hypochlorite between every subsequent instrument. XP Endo finisher is used after the last instrument in preparation
15991614|NCT02952326|Procedure|Conventional needle irrigation only|The canals will be thoroughly irrigated using 3ml syringe of 2.5% Sodium hypochlorite between every subsequent instrument.
15991615|NCT02952313|Device|Nasal Implant|
15991616|NCT02952300|Procedure|neolix|single rotation file
15991617|NCT02952300|Procedure|wave one|single reciprocation file
15991618|NCT02952287|Device|4D PC MRI acquisition|Flow-sensitive 4D-MRI acquisitions will be synchronized to the heart rate and breathing using prospective ECG-gating and adaptive diaphragm navigator gating41. The MRI sequence will consist of a segmented k-space spoiled gradient echo sequence with interleaved 3D velocity encoding. Data will be acquired in a sagittal oblique 3D data volume individually adapted to include the heart and the thoracic and upper abdominal vessels of interest like ascending, transverse and descending aorta, main and branch pulmonary arteries, pulmonary veins, superior and inferior vena cava, celiac and superior mesenteric vessels. Velocity encoding (VENC) will be set at 150-500 cm/sec to encompass flow in various vessels.
15991619|NCT02952274|Device|mandibular overdenture retained with single midline implant using locator attachment|
15991620|NCT02952274|Device|mandibular overdenture retained with single midline implant using ball attachment|
15991621|NCT02952261|Device|template-guided localization|Based on CT data, digital model of the navigational template was created using CAD software and imported to 3D printer. The navigational template serves as a guider to the localizer in lung nodule localization.
15991622|NCT02952261|Other|CT-guided localization|Percutaneous lung nodule localization was conducted under the real-time guidance of CT scan. This is the conventional method of transthoracic lung nodule localization.
15991623|NCT02952248|Drug|BI 754091|
15991624|NCT02952235|Other|SPF50+|Sun protection
15991625|NCT02952235|Other|SPF100+|Sun protection
15991629|NCT02952209|Device|Xenograft|
15991630|NCT02952196|Drug|drug administration|administering drug to patient with amphetamine addiction
15991631|NCT02952183|Device|PAMS I|"After general anesthesia, pressure sensor of PAMS I is placed into bladder, vagina and rectum. Then pressure change is monitored during performing pelvic autonomic nerve dissection.
~Both PAMS I and IOM will be used for monitoring."
15991632|NCT02952170|Other|MRI|MRI to assess hepatic steatosis
15991633|NCT02952157|Drug|Lidocaine jelly application|
15991634|NCT02952157|Drug|Normal saline application|
15991635|NCT02952144|Device|Lixelle® treatment|The treatment will be performed with the Lixelle® column connected to upstream of the dialyzer in series on the routine HD circuit according to the description in the IFU. The dialyzer and the Kt/V urea in the conventional HD for each patient will be kept equal in Lixelle®-treatment. Since the maximum blood flow rate for Lixelle® is 250 ml/min, the dialysis time will be extended to achieve the target Kt/V urea. The study will not restrict the type of hemodialyzer and other conditions of HD as specified by the physician. However, any changes to the HD procedure should be recorded properly, and the Kt/V urea should be kept equal to that at the enrollment.
15991636|NCT02952131|Procedure|Lipoaspiration|Closed Syringe Harvesting Autologous Subdermal Fat
15991637|NCT02952131|Procedure|AD-cSVF|Use of Centricyte 1000 to isolate adipose stem/stromal cells via centrifugation
15991638|NCT02952131|Procedure|Normal Saline IV|Normal Saline IV containing AD-cSVF
15991639|NCT02952118|Device|Forrest Snoring device|
15991640|NCT02952092|Drug|roxadustat|Oral
15991641|NCT02952092|Drug|Darbepoetin alfa|Intravenous
15991642|NCT02952079|Device|Blephex|Lid margin exfoliation
15991643|NCT02952079|Device|MiboFlo|Lid warming treatment
15991644|NCT02952066|Procedure|Bronchial biopsy|Bronchial tissue taken during biopsy
15991645|NCT02952053|Device|MTrP Group|"Deep Dry Needling into the site of the latent medial Myofascial Trigger Point of the soleus muscle.
~1 session in soleus muscle. 10 fast in and fast out needle insertions."
15991646|NCT02952053|Device|TB Group|"Deep Dry Needling distal to Myofascial Trigger Point but into the same taut band.
~1 session in soleus muscle. 10 fast in and fast out needle insertions."
15991647|NCT02952040|Drug|ASP1517|Oral dose
15991648|NCT02952040|Drug|Lanthanum carbonate hydrate|Oral dose
15991649|NCT02952027|Behavioral|Use-recording, patient-reminder alarm for incentive spirometry|
15991650|NCT02952014|Dietary Supplement|C4 Extreme|Pre-Workout Dietary Supplement
15991651|NCT02952014|Dietary Supplement|C4 Extreme (without Advantra Z|Pre-Workout Dietary Supplement
15991652|NCT02952014|Dietary Supplement|Placebo|Pre-Workout Dietary Supplement
15991653|NCT02952001|Drug|4 mg CLS-TA Suprachoriodal Injection|This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.
15991654|NCT02952001|Drug|Sham procedure|This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.
15991655|NCT02951988|Drug|Rapastinel|Rapastinel pre-filled syringes for IV injections.
15991656|NCT02951988|Drug|Placebo-matching Rapastinel|Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
15991657|NCT02951975|Drug|dexamethasone intravitreal implant|Dexamethasone intravitreal implant (OZURDEX®) as prescribed in clinical practice.
15991658|NCT02951962|Drug|Twynsta 80/5mg|Hypertension
15991659|NCT02951962|Drug|Crestor 20mg|Hyperlipidemia
15991660|NCT02951936|Device|NiCAS treated|"Measure each patient with the NiCAS once a day If Cardiac Index < 2.9 +Total Peripheral resistance Index >3000+Mean arterial pressure >70mmHG then add vasodilators.
~If Heart Rate<60 consider to reduce beta blockers dose If Cardiac Index>4.2 and Mean arterial pressure 70-100mmHG and HR >100 then add Bata Blockers If patient have low Total Body Water then reduce diuretics If patient have High Total Body Water provide diuretics"
15991661|NCT02951936|Device|Non NiCAS treated|Measure each patient with the NiCAS once a day Do note use the NiCAS parameters to direct treatment For treatment we will use the standard care
15991662|NCT02951923|Dietary Supplement|Bovine Colostrum|Bovine colostrum vs. soy during rugby training
15991663|NCT02951923|Dietary Supplement|Soy|
15991664|NCT02951910|Device|Ophylosa tear supplement|Tear film dynamics is assessed by non-invasive tear film breakup time (NI-BUT) in parallel with continuous recordings of ocular sensations during forced blinking. Corneal sensitivity thresholds to selective stimulation of corneal mechanonociceptors, thermal receptors and chemical nociceptors are assessed using the Belmonte gas esthesiometer. All baseline measurements are repeated after one month of tear supplementation with zinc-hyaluronate (Ophylosa eye drop) 4x/day
15991665|NCT02951897|Procedure|lobectomy|
15991666|NCT02951897|Procedure|segmentecomy|
15991667|NCT02951897|Drug|chemotherapy（pemetrexed+CISPLATIN）|
15991668|NCT02951897|Procedure|Lymphadenectomy|Lymphadenectomy or lymph node dissection is the surgical removal of one or more groups of lymph nodes. It is almost always performed as part of the surgical management of cancer. In a regional lymph node dissection, some of the lymph nodes in the tumor area are removed; in a radical lymph node dissection, most or all of the lymph nodes in the tumor area are removed.
15991712|NCT02951598|Drug|Florbetapir F 18 PET Scan|Florbetapir F 18 positron emission tomography (PET) scan performed at baseline to confirm amyloid status. Participants who previously tested amyloid positive were exempt. No therapeutic investigational drug(s) intended to treat AD will be administered.
15998554|NCT02900898|Other|Control|Control
15991669|NCT02951897|Other|CanPatrolTM to detect CTCs|CanPatrol TM was used to detect CTCs, which is a newly established technology to detect CTCs, containing the following steps: (1) To remove erythrocytes by red blood cell lysis and deplete CD45+ leukocytes in 10ml blood sample using a magnetic bead separation method; (2) To enrich CTCs by 8-μm-diameter-pore calibrated membrane filters; and (3) To identify and characterize CTCs by using RNA-in situ hybridization (ISH), based on the branched DNA (bDNA) signal amplification technology, to detect EMT markers, e.g., cytokeratins(CK) 8, 18 and 19, epithelial cell adhesion molecule (EpCAM), vimentin and twist. The details of classification of CTCs by using CanPatrol TM was depicted in the recently published protocol. Finally, the CTCs were clustered into three subtypes, as per the EMT markers, i.e., epithelial (E-) CTCs, mesenchymal (M-) CTCs and epithelial- mesenchymal (E&M-) CTCs.
15991670|NCT02951884|Procedure|Aspiration|A needle is placed into the knee joint and all of the blood that is in the joint is removed.
15991671|NCT02951884|Drug|Bupivacaine|An injection of 20cc bupivacaine 0.5% with 1:200,00 epinephrine
15991672|NCT02951858|Behavioral|Intervention Group|The medical staffs who received the training will use the manual of brief intervention to deliver BI and other materials about the harm of substance use.
15991673|NCT02951858|Behavioral|Control Group|The participants only receive the materials about the harm of substance use.
15991674|NCT02951845|Drug|JNJ-54416076 (Oral Suspension)|Participants will receive (25 mg) oral suspension of JNJ-54416076 in Part 1 and Part 2.
15991675|NCT02951845|Drug|JNJ-54416076 (Formulation 1: Direct Compression Tablets)|Participants will receive JNJ-54416076 Tablet formulation 1 (5*5 mg Tablets [25 mg total]) under fasted and fed condition in Part 1.
15991676|NCT02951845|Drug|JNJ-54416076 (Formulation 2: Fluid Bed Granulation Tablets)|Participants will receive JNJ-54416076 Tablet formulation 2 (5*5 mg Tablets [25 mg total]) under fasted and fed condition in Part 2.
15991677|NCT02951819|Drug|Daratumumab|"For induction therapy cycle 1 day 1 and day 2 doses of daratumumab will be 8 milligram/kilogram (mg/kg). Starting cycle 1 week 2 until the completion of week 8 of daratumumab patients will receive 16 mg/kg Intravenously (IV) weekly.
~Starting week 9 until the completion of week 24 therapy daratumumab will be administered every other week at 16 mg/kg IV.
~Starting week 25 and beyond for induction therapy daratumumab will be given once every 4 weeks."
15991678|NCT02951819|Drug|Cyclophosphamide|Subjects will receive 4 to 8 cycles of oral cyclophosphamide 300 milligram per meter square (mg/m^2 ) on Days 1, 8, 15, and 22 for every 28 days.
15991679|NCT02951819|Drug|Bortezomib|Subjects will receive 4 to 8 cycles of Bortezomib 1.5 mg/m2 subcutaneous (SC) on Days 1, 8, and 15 for every 28 days.
15991680|NCT02951819|Drug|Dexamethasone|Subjects will be given corticosteroids (Dexamethasone) as pre-infusion therapy prior to daratumumab and for the first 8 cycles will also receive post-infusion corticosteroids (Dexamethasone).
15991681|NCT02951806|Drug|(R) Rapid spinal fentanyl injection|Patients will receive 25 micrograms fentanyl ( after dilution with 2.5 ml CSF) in 20 seconds then 10 mg hyperbaric bupivacaine.
15991682|NCT02951806|Drug|(S) Slow spinal fentanyl injection|Patients will receive 25 micrograms fentanyl ( after dilution with 2.5 ml CSF) in 90 seconds then 10 mg hyperbaric bupivacaine.
15991683|NCT02951793|Other|AUDIT-C|Patients or their proxy/closest family member(s) undergo a comprehensive questionnaire including AUDIT-C about his/her alcohol behavior during last year and will be categorized into two groups: Those with AUDIT-C>4 versus AUDIT-C of 4 or below.
15991684|NCT02951793|Other|Smoking history|Patients or their proxy/closest family member(s) undergo a comprehensive questionnaire including smoking history during last year and will be categorized into two groups: Current smoker versus ex- or never smoker (we also recorded smoking pack-years to distinguish heavy smokers)
15991685|NCT02951793|Other|Prior psychotropic medication use|Patients or their proxy/closest family member(s) undergo a comprehensive questionnaire including psychotropic medication use prior admission to ICU and will be categorized into two groups: Those who use psychotropic medication versus those who do not use psychotropic medication.
15991686|NCT02951780|Drug|LY3185643|Administered SC
15991687|NCT02951780|Drug|rGlucagon|Administered SC
15991688|NCT02951767|Drug|Atezolizumab|Atezolizumab 1200 mg will be given by IV infusion on Day 1 of 21-day cycles until disease progression per RECIST v1.1 criteria or unmanageable toxicity.
15991689|NCT02951754|Drug|Immediate-release Methylphenidate|Standard initial dose of 10 mg, twice or three times daily with doses increasing weekly until symptom control or occurrence of limiting adverse effects
15991690|NCT02951741|Other|RTHRA group|hematologic variables measurement in patients undergoing revision total hip replacement
15991691|NCT02951728|Drug|Rituximab|
15991692|NCT02951728|Drug|Cyclophosphamide|
15991693|NCT02951728|Drug|Doxorubicin|
15991694|NCT02951728|Drug|Vincristine|
15991695|NCT02951728|Drug|Prednisone|
15991696|NCT02951728|Drug|Decitabine|
15991697|NCT02951715|Drug|zinc gluconate|2 months of treatment with zinc gluconate (Zinga 78 mg, 10 mg elemental zinc), two tablets twice per day (40 mg per day)
15991698|NCT02951702|Drug|Vancomycin Oral|"This arm will receive oral vancomycin 125 mg daily if high risk and determined to be appropriate by an ID physician"
15991699|NCT02951689|Dietary Supplement|Probiotic|
15991700|NCT02951689|Dietary Supplement|Placebo|
15991701|NCT02951676|Procedure|Extraction|Extraction of impacted third molar teeth
15991702|NCT02951663|Dietary Supplement|Protein|
15991703|NCT02951650|Device|Cyberonics VNS|Vagus nerve stimulation
15991704|NCT02951637|Drug|Pemetrexed plus carboplatin combined with gefitinib|Pemetrexed (500mg/m(2) d1) plus carboplatin (AUC5 d1) combined with gefitinib (250mg d4-28) and repeat every four weeks for up to six cycles and then continue to receive pemetrexed combined with gefitinib every four weeks.
15991705|NCT02951637|Drug|Gefitinib|Gefitinib (250mg daily)
15991706|NCT02951624|Behavioral|Control|Control intervention
15991707|NCT02951624|Behavioral|Breaker|Short breaks of physical activity
15991708|NCT02951624|Behavioral|Prolonger|longer breaks of physical activity
15991709|NCT02951624|Behavioral|Intermediate|Intermediate breaks of physical activity
15991710|NCT02951611|Procedure|Acupuncture stimulation|Transcutaneous electrical acupoint stimulation on SI3, SJ6, PC6 and LI4
15991711|NCT02951611|Procedure|Sham stimulation|Put electrodes on SI3, SJ6, PC6 and LI4 without stimulation
15991781|NCT02951182|Drug|IVA|
15991713|NCT02951585|Device|KARTILAGE CROSS|Intra-articular injection of Kartilage Cross
15991714|NCT02951585|Device|PLACEBO|Intra-articular injection of physiological serum (saline solution)
15991715|NCT02951572|Device|NIV|
15991716|NCT02951559|Device|Nasal Brushing|"Nasal brushing will be performed in non-sedated patients as follows. After administration of a local vasoconstrictor (1% epinephrine) with the use of a nasal tampon, inserted into the nasal cavity of the patient to locate the olfactory mucosa lining the nasal vault. A sterile, disposable brush (Copanflock, Copan, Brescia, Italy) will be inserted gently rolled on the mucosal surface, withdrawn,and immersed in 0.9% saline solution, UTM (Universal Transporter Medium) or 4% formaldehyde. Two swabs will be collected for each nostril."
15991717|NCT02951546|Dietary Supplement|Mediterranean diet|In the Mediterranean diet fat intake will be equal to 35% of the total energy intake minus carbohydrate and protein energy carbohydrate as 65% of total calorie intake, dietary cholesterol <300 mg/day, dietary fiber 25 g/day.
15991718|NCT02951546|Dietary Supplement|Low fat diet|In the hypocaloric low fat diet, fat will represent less than 25% of the total energy intake. Branched and essential amino acids will be administered taking into account the total protein intake.
15991719|NCT02951546|Other|Aerobic exercise|"A personalized program of aerobic exercise will be prescribed to the participants of both arms, following the FITT principles (frequency, intensity, time and type)."
15991720|NCT02951533|Drug|Guselkumab|Participants will receive 100 mg of Guselkumab as 100 mg/mL solution subcutaneously.
15991721|NCT02951533|Drug|Fumaric Acid Esters|Participants will receive Fumaderm initial/ Fumaderm tablets through self-administration.
15991722|NCT02951520|Procedure|new technique for lower limb nerve blocks using a single skin puncture (SOFT block)|The patients will be in supine position. The block needle will be inserted at the inguinal crease (medial to the femoral vein) and advanced towards the femoral nerve, then redirected towards the obturator nerve (deep to the pectineus muscle). Lastly, it will be redirected posteriorly towards the sciatic nerve (deep to the quadratus femoris muscle). A ropivacaine-lidocaine-epinephrine mixture will be used to block these nerves. The block success rate (painless surgery), performance time and patient discomfort will be recorded.
15991723|NCT02951507|Other|O T unilateral attachment|O T unilateral attachment system
15991724|NCT02951507|Other|New design of extracoronal attachment system|O T unilateral attachment
15991725|NCT02951494|Other|AlterG Anti-gravity treadmill|Participants in this group will complete a 12 week aerobic exercise training protocol with 40% lower body weight support on an AlterG Anti-gravity treadmill
15991726|NCT02951481|Behavioral|Systematic evaluation by an ID expert.|"Specific bundle of measures:
~Systematic evaluation of all patients diagnosed with CDI by an Infectious Disease expert To ensure compliance with clinical practice guidelines about specific treatment for CDI, depending on the severity of the episode and the existence of previous episodes and to optimize concomitant antibiotic therapy (antimicrobial stewardship).
~To ensure appropriate monitoring during the period of greatest risk of relapse in order to reduce as far as possible, the number of relapses. Personalized assistance by telephone or by email for early consultation in case of recurrence of symptoms or need for a new antibiotic course."
15991727|NCT02951468|Procedure|LCP plus iliac crest autograft|After exposure of the non- or malunion a complex multidimensional osteotomy of the clavicle with medial and lateral axial correction up to vital bone was performed [14]. Vital bone was verified by local blood extravasation resulting from drilling the previously osteotomized bone segments. The tricortical iliac crest bone graft was harvested according to the size assessed in the preoperative CT scan, consecutively adapted to the intraoperative measured size of the bony defect. After implantation of the bone graft the LCP was centered onto the clavicular shaft.
15991728|NCT02951455|Behavioral|Critical Dialogue|Prompted by thematic images, aims to help participants develop a deeper understanding of how marginalizing processes (e.g., systematic stigma; feelings of rage as victims of discrimination) impact participants' lives and behavior.
15991729|NCT02951455|Behavioral|Capacity Building Project|Designed to create collaborative efforts to overcome and dismantle marginalizing processes by building positive social and organizational relationships and community capacity through the development and implementation of community projects aiming to address social determinants of health.
15991730|NCT02951455|Behavioral|Quality of Life Wheel|Aims to increase self-efficacy and help participants develop a vision for their future, breaking this vision down into small, feasible, measureable goals they can implement on a weekly basis (e.g. quitting smoking, improving relationships with family members, paying down debt).
15991731|NCT02951455|Behavioral|PF|Whether the intervention is delivered by a peer facilitator.
15991732|NCT02951455|Behavioral|LC|Whether the intervention is delivered by a licensed clinician.
15991733|NCT02951442|Biological|Biological sample|
15991734|NCT02951442|Procedure|Non invasive Arterial investigations|
15991735|NCT02951442|Procedure|Abdominal tomodensitometry|
15991736|NCT02951429|Drug|Pirfenidone|Pirfenidone will be given in the range of 1602 to 2403 milligram per day (mg/day), as 3 divided doses.
15991737|NCT02951429|Drug|Placebo|Placebo matched with sildenafil.
15991738|NCT02951429|Drug|Sildenafil|Sildenafil will be given as 20 mg, TID.
15991739|NCT02951416|Other|patient registry (observation and biomaterial sampling)|data are collected with patient questionnaires, additionally clinical data are collected at every routine visit and biomaterial is collected
15991740|NCT02951403|Procedure|Elbow arthroscopy|Arthroscopic debridement, osteophyte excision, loose body extirpation is carried on to patients.
15991741|NCT02951403|Other|Conservative treatment|Physiotherapy protocol is introduced to patients.
15991742|NCT02951390|Other|High-definition white-light endoscopy|The intervention is do not perform chromoendoscopy
15991743|NCT02951377|Other|Exercise (MDT approach)|Postural or movement exercises of the lower back that aim to centralise and reduce pain intensity.
15991744|NCT02951377|Drug|Transforaminal epidural steroid injection (20mg dexamethasone 0.5cc lidocaine 2%)|An epidural steroid injection (20mg dexamethasone 0.5cc lidocaine 2%), under guidance of fluoroscopy is used to reduce inflammation at a lumbar spinal nerve root(s).
15991746|NCT02951351|Drug|Proparacaine|Extra proparacaine will be applied to the conjunctival surface to determine its role in patient experience.
15991782|NCT02951182|Drug|VX-440|
15991783|NCT02951182|Drug|Matched Placebo|
15991747|NCT02951351|Procedure|Conjunctival culture|Conjunctival cultures will be performed to ensure that the intervention does not interfere with antisepsis.
15991748|NCT02951338|Behavioral|PROPEL program|The PROPEL program involves both group aerobic exercise and group discussion aimed at enabling participation in exercise after discharge. Components of the PROPEL program were developed according to the Transtheoretical Model of health behaviour change and Social Cognitive Theory. In addition to group exercise participants will attend 1-hour small group discussion sessions once weekly to learn self-management skills for exercise in preparation for discharge from rehabilitation. These discussions include: identifying and solving problems around barriers to exercise; understanding personal and general benefits of exercise; exploring appropriate community resources for exercise; and finding individualized and realistic strategies for incorporating exercise in a regular routine. Participants will become comfortable with progressing their exercise and will set short- and long-term exercise goals.
15991749|NCT02951338|Other|Group aerobic exercise|"Supervised group exercise up to 3-times/week for 6 weeks. A typical exercise session will involve a 3-5 minute 'warm-up', 20-30 minutes of aerobic exercise at a target heart rate determined from a sub-maximal test, and a 3-5 minute 'cool-down' of low-intensity exercise. The choice of exercise modality for the submaximal test and for training (e.g., recumbent stepper, cycle ergometer, or treadmill) will be individually prescribed based on patients' sensori-motor recovery, postural control, functional abilities, and safety. Heart rate, blood pressure, rate of perceived exertion, workload, and duration of training will be documented for each session. These data will be reviewed by the physiotherapist with appropriate progression of the intensity and/or duration of exercise as necessary.
~Participants may receive general advice to keep physically active after discharge, and may receive an individualized home exercise program, as is currently routine care at all sites."
15991750|NCT02951325|Other|Adjuvant RT|"Radiation therapy:
~All patients will be offered conformal technique with IMRT +/- image guidance. The adjuvant RT will start within 8 weeks from the date of surgery if chemotherapy not planned or 4 weeks from the date of last adjuvant chemo cycle.
~Dose:
~•50.4 Gray (Gy) in 28 fractions (1.8Gy/#) for the nodal PTV. For R1 and/or R2 resection increased to 54-56 Gy in 28 fractions based on the constraints achieved during planning.
~Patient assessments:
~Clinical:
~Toxicity:
~Weekly RT with toxicity scoring.
~RTOG toxicity criteria at baseline, 6-8 weeks post RT and f/b 3 monthly x 2 years and 6 monthly x 5 years.
~QOL will be assessed at baseline f/b 3-6 monthly.
~Disease evaluation:
~i. first f/u all patients will be at 6-8 week to assess toxicity. ii. Clinical evaluation of the disease will be done at each f/u visit. iii. CT scan (abdomen and pelvis) 6 monthly from visit 2 onwards up to 2 years f/b 12 monthly or as clinically indicated."
15991751|NCT02951312|Drug|Glycopyrrolate Inhalation Solution 25mg|25 μg oral inhalation via eFlow Nebulizer, once daily
15991752|NCT02951312|Drug|Glycopyrrolate Inhalation Solution 75mg|75 μg oral inhalation via eFlow Nebulizer, once daily
15991753|NCT02951312|Drug|Glycopyrrolate Inhalation Solution 200mg|200 μg oral inhalation via eFlow Nebulizer, once daily
15991754|NCT02951312|Drug|Glycopyrrolate Inhalation Solution 200mg Jet|200 μg oral inhalation via inhalation via jet nebulizer, once daily
15991755|NCT02951312|Drug|Glycopyrrolate Inhalation Solution 500mg|500 μg oral inhalation via eFlow nebulizer, once daily
15991756|NCT02951312|Drug|Glycopyrrolate Inhalation Solution1000mg|1000 μg oral inhalation via eFlow nebulizer, once daily
15991757|NCT02951312|Drug|Placebo|Placebo 0.5 mL oral inhalation via jet nebulizer, once daily
15991758|NCT02951299|Drug|Pentoxifylline 400Mg Tablet|Investigators with AKI will received oral pentoxifylline (400 mg) three times a day for 14 days or no pentoxifylline according to their decision.
15991759|NCT02951286|Device|high pull headgear + OBA|a modified version of the OBA (Open Bite Appliance),introduced by Erverdi and Usumez, will be applied in compination with a high pull headgear.
15991760|NCT02951286|Device|OBA (control group)|A modified version of the OBA (Open Bite Appliance),introduced by Erverdi and Usumez, will be applied alone (Control group)
15991761|NCT02951273|Other|Study of cerebral blood flow|"Measurements are conducted from before induction of anaesthesia and until 2 hours after the start of surgery and include internal carotid artery blood flow, mean arterial pressure, heart rate, stroke volume, cardiac output, total peripheral resistance, forehead skin blood flow and haemoglobin concentrations, depth of anaesthesia, and frontal lobe, skin, and muscle oxygenation. Further measurements are conducted during hyperventilation before induction of anaesthesia and during hypo-, normo- and hypercapnia during anaesthesia.
~Blood samples are obtained from the arterial line for evaluation of the arterial CO2 tension and markers of mesenteric traction syndrome. Total volume of blood sampled is less than 75 ml."
15991762|NCT02951260|Drug|Metformin|17 days treatment with metformin
15991763|NCT02951260|Other|Placebo|17 days treatment with placebo
15991764|NCT02951247|Device|Hearing Aid|Successor of Phonak Virto V90-10 NW O
15991765|NCT02951234|Other|IVIG only|All patients will receive IVIG (2g/kg) in 10-12 hours alone, without high-dose aspirin.
15991766|NCT02951234|Other|IVIG and Aspirin|All patients will receive IVIG (2g/kg) in 10-12 hours plus high-dose aspirin (80-100mg/kg/day, divided into four doses) till fever subside.
15991767|NCT02951221|Drug|BIIB074 Treatment A|Lower dose RCF fasted
15991768|NCT02951221|Drug|BIIB074 Treatment B|Lower dose DCF fasted
15991769|NCT02951221|Drug|BIIB074 Treatment C|Higher dose DCF fasted
15991770|NCT02951221|Drug|BIIB074 Treatment D|Higher dose DCF fed
15991771|NCT02951208|Device|Active tDCS|Active anodal tDCS over the left DLPFC, administered for 30 minutes, three times per week for four weeks.
15991772|NCT02951208|Behavioral|Active VR Motivation Training|Active computerized treatment with a virtual reality-based motivation training program, administered for 60 minutes, three times per week for four weeks.
15991773|NCT02951208|Device|Sham tDCS|Sham anodal tDCS over the left DLPFC, administered for 30 minutes, three times per week for four weeks.
15991774|NCT02951208|Behavioral|Sham VR Motivation Training|Sham computerized training in a virtual reality-based environment, administered for 60 minutes, three times per week for four weeks.
15991775|NCT02951195|Drug|VX-152|Tablet for oral administration.
15991776|NCT02951195|Drug|TEZ/IVA|Fixed-dose combination tablet for oral administration.
15991777|NCT02951195|Drug|IVA|Tablet for oral administration.
15991778|NCT02951195|Drug|Placebo|Placebo matched to VX-152.
15991779|NCT02951195|Drug|Placebo|Placebo matched to VX-152/TEZ/IVA triple combination (TC).
15991780|NCT02951182|Drug|TEZ|
15991784|NCT02951169|Other|No intervention|No intervention. Treatment are accordance with clinical practice.
15991785|NCT02951156|Biological|Avelumab|Investigational fully human anti-PD-L1 monoclonal antibody
15991786|NCT02951156|Biological|Utomilumab|Investigational, fully human IgG2 CD 137/4-1BB agonist
15991787|NCT02951156|Biological|Rituximab|CD20-directed cytolytic antibody
15991788|NCT02951156|Other|Azacitidine|Antimetabolite antineoplastic agent and demethylation agent.
15991789|NCT02951156|Drug|Bendamustine|Alkylating drug
15991790|NCT02951156|Drug|Gemcitabine|Nucleoside analogue
15991791|NCT02951156|Drug|Oxaliplatin|Platinum-based drug
15991792|NCT02951143|Drug|SPECTRUM cigarettes|Across six laboratory sessions, participants will consume 10 puffs of either their usual brand of cigarette (one session) or a SPECTRUM cigarette (five sessions) with a nicotine yield varying from 0.03 to 0.70 and either menthol (TPMF codes NRC 103, NRC 201, NRC 301, NRC 401, and NRC 601) or tobacco (TPMF codes NRC 102, NRC 200, NRC 300, NRC 400, and NRC 600) flavor, depending on preference. This will be followed by the collection of blood nicotine content and a cigarette purchase task.
15991793|NCT02951143|Drug|SPECTRUM cigarettes between|Participants will be assigned one of the nicotine concentrations of a SPECTRUM cigarette. They will complete a cigarette purchase task and make real purchases for the next week. Participants will return and make purchases again, repeating 4 times.
15991796|NCT02951117|Drug|Venetoclax|Tablet
15991797|NCT02951117|Drug|ABBV-838|Intravenous infusion
15991798|NCT02951117|Drug|Dexamethasone|Tablet or intravenous infusion
15991799|NCT02951104|Device|Ultrasonic Cardiac Output Monitor (USCOM) system|
15991800|NCT02951091|Other|biomarker screening|immunohistochemistry and in situ hybridization
15991801|NCT02951078|Procedure|Thulium Laser en Bloc Resection of bladder tumor|
15991802|NCT02951078|Procedure|Electrical transurethral resection of bladder tumor|
15991803|NCT02951065|Other|Tooth brush without nylon bristles|Subjects will use a bristle-less tooth brush. Subjects in both arms of the study will use the same waxed, mint-flavored floss; baking-soda based tooth paste; exams and professional tooth cleaning every 3-4 months; oral hygiene instruction every 3-4 months
15991804|NCT02951065|Other|Tooth brush with soft nylon bristles|Subjects will use a soft bristled tooth brush. Subjects in both arms of the study will use the same waxed, mint-flavored floss; baking-soda based tooth paste; exams and professional tooth cleaning every 3-4 months; oral hygiene instruction every 3-4 months
15991805|NCT02951052|Drug|Cabotegravir (CAB) tablet|It is a white oval shaped film coated 30 mg tablets for oral administration. CAB Tablet is composed of cabotegravir sodium, lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycolate, magnesium stearate, and white film-coat
15991806|NCT02951052|Drug|Rilpivirine (RPV) tablet|"It is a 25 mg tablet with off-white, round, biconvex, film-coated and debossed on one side with TMC and the other side with 25. Each tablet contains RPV hydrochloride, and the inactive ingredients croscarmellose sodium, lactose monohydrate, magnesium stearate, polysorbate 20, povidone K30 and silicified microcrystalline cellulose"
15991807|NCT02951052|Drug|Cabotegravir - Injectable Suspension (CAB LA)|It is a sterile white to slightly pink suspension containing 200 mg/mL of CAB as free acid for administration by intramuscular (IM) injection. Each vial is for single-dose use containing a withdrawable volume of 2.0 mL, and does not require dilution prior to administration. CAB LA is composed of cabotegravir free acid, polysorbate 20, polyethylene glycol 3350, mannitol, and water for injection
15991808|NCT02951052|Drug|Rilpivirine - Injectable Suspension (RPV LA)|It is a sterile white suspension containing 300 mg/mL of RPV as the free base. The route of administration is by intramuscular (IM) injection. Each vial contains a nominal fill of 2.0 mL, and does not require dilution prior to administration. RPV LA requires refrigeration and must be protected from light. RPV LA is composed of RPV free base, poloxamer 338, sodium dihydrogen phosphate monohydrate, citric acid monohydrate, glucose monohydrate, sodium hydroxide, water for injection.
15991809|NCT02951052|Drug|2 NRTIs plus an INI, NNRTI, or PI|"Acceptable stable (initial or second) ARV regimens include 2 NRTIs plus:
~INI with the exception of ABC/DTG/3TC (either the initial or second cART regimen)
~NNRTI (either the initial or second cART regimen)
~Boosted PI (or atazanavir [ATV] unboosted) (either the initial or second PI-based cART regimen)"
15991810|NCT02951039|Drug|Edoxaban|Prescribed according to approved label
15991811|NCT02951026|Other|Not applicable (no therapy is administered as part of this study)|"No experimental therapy or placebo is being administered in this study. All subjects in this observational study received a single intra-articular injection of SM04690 or placebo in a prior parent study."
15991812|NCT02951013|Other|restrictive transfusion|Transfusion will start when the hemoglobin concentration falls below 6.0 g/dL
15991813|NCT02951013|Other|liberal transfusion|
15991814|NCT02951000|Procedure|platysma suture|
15991815|NCT02951000|Procedure|no platysma suture|
15991816|NCT02950987|Device|Whole Body MRI|
15991817|NCT02950974|Drug|Sterofundin|Fluid loading
15991818|NCT02950974|Drug|NSS|Fluid loading
15991819|NCT02950961|Behavioral|Collaborative Care for Women Veterans|This is a collaborative care model that focuses on identifying need for depression and/or anxiety care. Patients with possible anxiety and/or depression are referred to a care manager in primary care-mental health integration. The care manager then conducts a thorough assessment, offers the patient a variety of appropriate treatment options, and works with the patient to determine a care plan. One of the key options the investigators will be offering in this study is the Calm Tools for Living (CALM) intervention, which is focused on anxiety and which is rooted in patient preferences. Patients can choose web-based cognitive behavioral therapy (CBT) and/or pharmacologic treatment. In this study the investigators will be training appropriate MH providers in CALM and studying the ways in which the intervention needs to be tailored to women Veterans. The investigators will also examine the relative importance of patient preference with regard to engagement and retention in care.
15991820|NCT02950948|Drug|Progesterone|Progesterone will be administered subcutaneously once a day for 14 days/month, for 12 months.
15991821|NCT02950948|Drug|Placebo|A placebo solution will be administered subcutaneously once a day for 14 days/month, for 12 months.
15991822|NCT02950935|Drug|Progesterone|subcutaneous injection of progesterone solution will be performed twice à day from onset of threatened abortion symptoms until week 12 of pregnancy.
15991823|NCT02950935|Drug|Placebo|subcutaneous injection of placebo solution will be performed twice à day from onset of threatened abortion symptoms until week 12 of pregnancy.
15991824|NCT02950922|Drug|RVT-501 0.2% ointment|
15991825|NCT02950922|Drug|RVT-501 0.5% ointment|
15991826|NCT02950922|Other|Vehicle ointment|Placebo comparator
15991827|NCT02950909|Procedure|Static exercise for emphasized neck extensors|Emphasized activation of the deep neck extensors was searched for applying a localized resistance with the thumb and index finger at the level of the vertebral arch of C4 while pushing into flexion in a ventral-cranial direction, approximately parallel to the surface of the zygapophyseal joint, asking the patient to resist maximally during 6 seconds in sitting position
15991828|NCT02950909|Procedure|Dynamic exercise for emphasized neck extensors|The patient was asked to fix his gaze at an object lying between both elbows hoping to in order to emphasize extension in the lower cervical spine and consequently activation of the extensors in this region.
15991829|NCT02950909|Procedure|Static exercise for general neck extensors|Emphasized activation of all neck extensors was searched for applying the resistance with the therapist's hand or a wall respectively a towel at the occiput in sitting position
15991830|NCT02950909|Procedure|Dynamic exercise for general neck extensors|. The patient was asked to fix his gaze at an object lying between both hands. Extension consequently occurred in the entire cervical spine.
15991831|NCT02950896|Other|observational fetal heart rate monitoring|Patients will have fetal heart rate monitoring
15991832|NCT02950883|Drug|Active Treatment Group 7% Hypertonic Saline|"Drug: 7% Hypertonic Saline (HS) 4 mL of HS will be administered via inhalation twice daily for 48 weeks. The delivery system is a PARI Sprint Junior nebulizer with a PARI Baby face mask or mouthpiece driven by a PARI compressor (PARI Vios® Pro in USA, PARI BOY SX in Australia and Europe).
~Other Names:
~Hyper-Sal™, inhaled saline"
15991833|NCT02950883|Drug|Control Group 0.9% Isotonic Saline|"Drug: 0.9% Isotonic Saline (IS) 4 mL of IS will be administered via inhalation twice daily for 48 weeks The delivery system is the same as that for the test product.
~Other Names: Normal saline"
15991834|NCT02950870|Drug|Ombitasvir-Paritaprevir-Ritonavir|The patient will be treated daily with Ombitasvir-Paritaprevir-Ritonavir 25/150/100 mg total dose
15991835|NCT02950870|Drug|Dasabuvir|The patient will be treated daily with Dasubavir 500 mg total dose
15991836|NCT02950870|Drug|Ribavirin|Patients will be treated with ribavirin if necessary.
15991837|NCT02950857|Drug|EPEG|(Pegylated erythropoeitin)
15991838|NCT02950844|Other|Novel mapping algorithm|"Mapping and ablation of atrial fibrillation drivers identified by the STAR mapping algorithm.
~In a sub-study a novel mapping system (CARTOFINDER, Biosense Webster, Inc, CA) was used in mapping drivers in AF."
15991839|NCT02950831|Other|Accelerometry|Record of activity levels using a wrist worn accelerometer
15991840|NCT02950818|Behavioral|Take Heart|Participants receive an evidence-based heart disease self management program consisting of a combination of five two and a half hour group sessions and telephone counseling offered by a trained facilitator employed by the Detroit Area Agency on Aging. The program is designed so that participants select an area to work on (e.g., diet, exercise, medication taking, communication with health care professionals) and receive support, information, and encouragement from group members and program facilitators, to help them reach their goals.
15991841|NCT02950805|Drug|Placebo|Subjects will receive a placebo in either period 1 or period 2 by inhalation.
15991842|NCT02950805|Drug|AZD5634|Subjects will receive a single tentative dose of 625 μg of AZD5634 in either period 1 or period 2 by inhalation.
15991843|NCT02950792|Device|ViewRay MRI|ViewRay Magnetic Resonance Imaging
15991844|NCT02950792|Radiation|Stereotactic Body Radiation Therapy Boost|In the (week 5), all patients will have a week 5 MRI and Four-dimensional computed tomography (4D CT) for purposes of planning Phase II boost. Gross tumors < 5 cm will receive a MR-based adaptive replanning Stereo boost of 80 Gy - 90 Gy (20 Gy-30 Gy in 5 fractions). Gross tumors < 5cm will receive an MR-based adaptive replan fractionated boost to 74 Gy at 2.4 Gy/day. Individualized radiation therapy prescription to primary tumor will maintain organs at risk (OAR) constraints to lung including mean lung dose (MLD) < 20 Gy with V20 < 37%. Simultaneously, MRI-based adaptive replanning boost of 12 Gy in 5 fractions (2.4 Gy/day) will be given to gross lymph nodes. Final doses prescribed will be limited by doses to all OARs.
15991845|NCT02950779|Other|Handgrip Strength Measurement|
15991846|NCT02950766|Drug|NeoVax|combination of Neoantigen peptides and poly-ICLC
15991847|NCT02950766|Drug|Ipilimumab|local administration of ipilimumab
15991848|NCT02950753|Drug|Lactated Ringer Solution|Fluid bolus of Lactated Ringer solution (30ml/kg).
15991849|NCT02950753|Drug|Normal Saline|Fluid bolus or Normal Saline (30ml/kg).
15991850|NCT02950727|Device|3 bicortical screws|after mandibular bilateral sagittal split ramus osteotomy surgery is performed in the first group the osteotomy will be fixed using 3 bicortical screws
15991851|NCT02950727|Device|adjustable plate and 2 bicortical screws|after mandibular bilateral sagittal split ramus osteotomy surgery is performed in the second group the osteotomy will be fixed using adjustable plate and 2 bicortical screws
15991852|NCT02950714|Other|LIN_NOW|The Lupus interactive navigator (LIN) was developed to facilitate and support engagement and self-management for persons with lupus. It is a web-based program that provides access to relevant information, resources, support, and other tools to help them manage their illness. It is accessible by the Internet and compatible for use with computer, tablet, and mobile device. The content for the LIN was based on the results of focus group discussions and web-based surveys of persons with lupus and health care providers. Medical researchers, writers, designers and programmers worked with clinical experts affiliated with the Canadian Network for improved outcomes in Systemic Lupus Erythematosus (CaNIOS) and persons with lupus to provide the written content and interview videos.
15991853|NCT02950714|Other|LIN_WAIT|Usual care for three months prior to access to the LIN
15991854|NCT02950701|Device|Observational data collection.|
15991855|NCT02950688|Biological|Seasonal LAIV|10^7.0 fluorescent focus units (FFU); administered by intranasal spray
15991856|NCT02950688|Biological|Placebo|Administered by intranasal spray
15991857|NCT02950688|Biological|Wild-type A/California/2009-like Influenza Virus|Approximately 3.5 x 10^6 TCID50; administered intranasally
15991858|NCT02950662|Other|Overdenture|Active comparator will be metal housing and peek housing
15991859|NCT02950649|Device|invasive Hemodynamic monitoring via Clearsight/Nexfin Systems from Edwards Lifesciences|Experimental: Hemodynamic Monitored Guided Assesment This group will have the non-invasive hemodynamic monitoring device placed and its data will help guide (intervention) patient's management decisions (experimental).
15991860|NCT02950649|Device|No Hemodynamic Monitored Guided Assesment|Arm: Active Comparator: No Hemodynamic Monitored Guided Assesment This group will have the non-invasive hemodynamic monitoring device placed but its data will NOT be factored for intervention of the patient's management decisions.
15991861|NCT02950636|Other|Yoga|Restorative Yoga
15991862|NCT02950623|Other|titanium dioxide denture|patients will receive titanium dioxide denture (made from acrylic resin with titanium dioxide nanoparticles ) for 1 month in the initial phase then in the second phase after one month they will receive( rapid heat cured acrylic resin)denture according to the principle of crossover design
15991863|NCT02950623|Other|rapid heat denture|patients will receive rapid heat denture for 1 month in the initial phase of the trial then in the later phase patients will receive titanium dioxide denture (made from conventional acrylic resin modified by titanium dioxide nanoparticles ) according to the principle of crossover design
15991864|NCT02950610|Device|"Breath analysis - electronic signature Breath-print"|Patients and Healthy volunteers ( as defined in 3 cohorts) will breath into disposable, once-use only bacterial filter channeled into electronic device comprising on sensors capable to reacting to organic compounds. Breathing manoeuvre will be simple, non-exertional and relaxed. 2 breathing manoeuvres will be performed and sensor responses will be captured.
15991865|NCT02950597|Device|Observational Study to Evaluate Utility of Non-invasive Hemodynamic Monitoring|
15991866|NCT02950584|Other|Titanium dioxide denture|Patients will receive titanium dioxide denture (made from acrylic resin with titanium dioxide nanoparticles) for 1 month in the initial phase then in the second phase after one month they will receive (rapid heat cured acrylic resin)denture according to the principle of crossover design
15991867|NCT02950584|Other|Rapid heat denture|Patients will receive rapid heat denture for 1 month in the initial phase of the trial then in the later phase patients will receive titanium dioxide denture (made from conventional acrylic resin modified by titanium dioxide nanoparticles) according to the principle of crossover design
15991868|NCT02950571|Behavioral|Digital Picture Frame|The intervention is the provision of digital picture frames in long stay inpatient rooms in a ward at CAMH.
15991869|NCT02950571|Behavioral|Standard Care|High level of support from an interdisciplinary team.
15991870|NCT02950558|Drug|Ropivacaine|Single injection of ropivacaine immediately prior to surgery.
15991871|NCT02950558|Procedure|Nerve block|insertion of catheter to deliver continuous 5 day popliteal sciatic nerve block using a disposable ambulatory pain pump.
15991872|NCT02950545|Device|Placebo Lenses|AcuVue Oasys Bandage Lenses with no prescription
15991873|NCT02950545|Device|Spherical Lenses|1-DAY ACUVUE® MOIST contact lenses
15991874|NCT02950545|Device|Toric Lenses|1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses
15991875|NCT02950532|Other|Retrospective radiological evaluation|Radiological evaluation will be performed in already existing imaging exams. Superior-inferior end plate angle (SIEA), vertebral body height (BH), local kyphosis (LK), inter-spinous distance (ISD) and inter-pedicular distance (IPD) will be measured in CT scans and radiographs (if available). PLC injury will be determinated with the gold standard method (MRI).
15991876|NCT02950519|Other|monitoring of cuff pressures|Cuff pressure will be checked per standard and additionally a minimum of every 8 hours.
15991877|NCT02950506|Device|transcranial direct current stimulation|The anode will be placed over left DLPFC at F3, according to the 10-20 international system for EEG electrode placement. The cathode will be placed over the contralateral supraorbital area. They will be placed via two saline soaked electrode sponges (3 cm x 4.5 cm).After electrodes have been placed, the participants will be instructed to log into CRT software using a unique patient identifier. The CRT software that will be used will be Cogmed working memory training program (Pearson Education, Inc.)Active tDCS will be applied at a ramp-like fashion from 0 to 2mA over 10 seconds, and will be ramped down for the last 10 seconds of stimulation. Active tDCS will last 20 minutes each session. The sham procedure involves only 30 seconds of stimulation at 2mA.
15991878|NCT02950506|Other|Cognitive Remediation Therapy|The CRT software that will be used will be Cogmed working memory training program (Pearson Education, Inc.). Cogmed is a targeted computerized training program that has been shown to improve working memory and attention. (Spencer-Smith 2015).
15991879|NCT02950493|Other|perflutren lipid microsphere|Definity and Lumason are tools for diagnosis used in echocardiography. Compare activated Definity or Lumason with compressed Definity or Lumason.
15991880|NCT02950480|Drug|zafirlukast|Patients will begin treatment with zafirlukast on post-operative day one following placement of tissue expander(s) once determined safe from a surgical recovery standpoint. They will be continued on the standard dosing (20mg PO twice per day) of zafirlukast through expander fill (6-12 weeks, up to 18 weeks for women receiving radiation). Treatment will be stopped 48 hours prior to expander-implant exchange, which is equivalent to five half-lives of the drug. Patients will be seen every 1 to 2 weeks for expander fill, and will be assessed clinically based on the Baker classification system of capsular contracture every two weeks.
15991881|NCT02950480|Other|Standard of Care (no intervention)|Standard of Care (no intervention)
15991882|NCT02950467|Drug|Psilocybin|One individual oral psilocybin treatment session
15991883|NCT02950467|Behavioral|Modified brief Supportive Expressive Group Therapy|Ten sessions of twice-weekly manualized group therapy
15991884|NCT02950454|Other|High intensity interval training|1.5 min intervals at 80-95% heart rate max on cycle ergometer 1.5 min intervals at nominal resistance on cycle ergometer
15991885|NCT02950454|Other|Continuous moderate exercise|20 min at 60-70% heart rate max on cycle ergometer
15991886|NCT02950441|Dietary Supplement|Nicotinamide Riboside|
15991887|NCT02950441|Other|Placebo|
15991888|NCT02950428|Device|ACURATE neo™TA Delivery System|ACURATE neo™ Aortic Bioprosthesis and ACURATE neo™TA Transapical Delivery System on patients with severe aortic stenosis where conventional aortic valve replacement (AVR) via open-heart surgery is considered to be high risk
15991889|NCT02950415|Behavioral|virtual|Parent is present via an internet pad (iPad)
15991890|NCT02950415|Behavioral|coaching|Parent learns what to say verbally to soothe child
15991891|NCT02950415|Behavioral|physical|Parent is present in the operating room
15991892|NCT02950415|Behavioral|no coaching|Parent does not learn what to say verbally to soothe child
15991893|NCT02950402|Other|Two Dried Plums per day|Subjects will consume Two Dried Plums per day
15991894|NCT02950402|Other|Six Dried Plums per day|Subjects will consume Six Dried Plums per day
15991895|NCT02950389|Device|PMMA filter|
15991896|NCT02950389|Device|HFR17 filter|
15991897|NCT02950389|Device|F7 filter|
15991898|NCT02950376|Other|DSM-5 +Virtual reality-based addiction assessment system|The patients who used the amphetamine type stimulants will be diagnosed by the chief physician、associate chief physician or attending physician first to evaluate their addiction severity. And then the patients will finish the test in the virtual environment, at the same time their eye movement index and other physiological data will be recorded .Physiological data includes cardiac rate、galvanic skin response and electroencephalogram and so on.The test will proceed at the beginning of withdrawl、3 months later、 6 months later and 1 year later and record the information synchronously.
15991899|NCT02950376|Other|Virtual reality-based addiction assessment system|The healthy controls will finish the test in the virtual environment, at the same time their eye movement index and other physiological data will be recorded .Physiological data includes cardiac rate、galvanic skin response and electroencephalogram and so on.The test will proceed at the baseline and 1 month later and record the information synchronously.
15991900|NCT02950376|Other|DSM-5 +Virtual reality-based addiction assessment system|The patients who used the amphetamine type stimulants will be diagnosed by the chief physician、associate chief physician or attending physician first to evaluate their addiction severity. And then the patients will finish the test in the virtual environment, at the same time their eye movement index and other physiological data will be recorded .Physiological data includes cardiac rate、galvanic skin response and electroencephalogram and so on.In this group which is designed to construct the norm of assessment system, the test will record the information synchronously and proceed after baseline assessment.
15991901|NCT02950337|Radiation|Group 1: Peripherally Located Tumors|Group 1: For peripherally located tumors patients will receive SBRT(Stereotactic Body Radiation Therapy) , 3 fractions of 18 Gy to a total dose of 54 Gy, with a minimum of 40 hours between each treatment fraction is required. ( Gy = Gray and is the unit used to measure the total amount of radiation a patient is exposed to)
15991902|NCT02950337|Radiation|Group 2: Peripherally Located Chest Wall Adjacent Tumors|Group 2: For chest wall adjacent tumors patients will receive SBRT (Stereotactic Body Radiation Therapy) , 5 fractions of 12 Gy to a total dose of 60 Gy, with a minimum of 40 hours between each treatment fraction is required. ( Gy = Gray and is the unit used to measure the total amount of radiation a patient is exposed to)
15991903|NCT02950337|Radiation|Group 3: Centrally Located Tumors|Group 3: For central tumors patients will receive SBRT (Stereotactic Body Radiation Therapy) , 5 fractions of 10 Gy to a total dose of 50 Gy, with a minimum of 40 hours between each treatment fraction is required. ( Gy = Gray and is the unit used to measure the total amount of radiation a patient is exposed to)
15991904|NCT02950324|Behavioral|Prehabilitation|Patients in the intervention, 'Prehabilitation', arm of the study will be enrolled into a multimodal programme that involves 15 weeks of exercise, nutritional support and psychological prehabilitation in the form of 'Medical Coaching'. This will take place during neo-adjuvant treatment prior to oesophagectomy or gastrectomy for cancer.
15991905|NCT02950324|Behavioral|Standard care|Patients in the 'standard care' arm of the study will not receive the study intervention. The patients will continue to be offered theatients in this arm of the study will not receive the study intervention. The patients will continue to be offered the standard dietetic and psychological support as per the enhanced recovery pathway and current standard of care standard dietetic and psychological support as per the enhanced recovery pathway and current standard of care.
15991906|NCT02950311|Drug|Intranasal xylitol spray|Two sprays into each nostril of intranasal xylitol spray will be administered to pediatric patients by parent(s)/caregiver(s) twice daily for 24 weeks.
15991907|NCT02950311|Other|Intranasal saline spray|Two sprays into each nostril of intranasal xylitol spray will be administered to pediatric patients by parent(s)/caregiver(s) twice daily for 24 weeks.
15991908|NCT02950285|Other|Baseline alert|PCP notification at baseline that patient has atrial fibrillation, high stroke risk, and is not anticoagulated.
15991909|NCT02950259|Drug|Cyclophosphamide|One dose of cyclophosphamide 300 mg/m2 IV infusion
15991910|NCT02950259|Drug|Indomethacin|Indomethacin 25 mg three times a day for 21 days
15991911|NCT02950259|Drug|Omeprazole|One tablet of omeprazole daily for 21 days
15991912|NCT02950259|Dietary Supplement|Multivitamin|Daily multivitamin containing 15-30 mg of zinc for 21 days.
15991913|NCT02950246|Procedure|perineural catheterization implementation|Skin preparation (disinfection) with 10 ml of 2% alcoholic Chlorhexidine Perineural catheterization implementation Ultrasonography use
15991914|NCT02950246|Drug|2% alcoholic chlorhexidine|
15991915|NCT02950246|Drug|povidon iodine|
15991916|NCT02950233|Drug|NMDA active|NMDA active group will involve ketamine (0.5 mg/kg IV bolus pre-incision and 0.1 mg/kg/hr infusion postoperatively up to 24 hours) and oral memantine (5 mg BID [first week]; 10 mg BID [following three weeks]).
15991917|NCT02950233|Drug|Steroid active|Steroid active group will involve two doses of dexamethasone; 25 mg given prior to starting surgery and 25 mg given on the morning of second postoperative day.
15991918|NCT02950233|Drug|NMDA placebo|NMDA active group will involve normal saline (IV bolus pre-incision and infusion postoperatively up to 24 hours) and oral matching placebo to memantine (1 capsule BID [first week]; 1 capsule BID [following three weeks]).
15991919|NCT02950233|Drug|Steroid placebo|Steroid placebo group will involve two doses of normal saline; one dose given prior to starting surgery and one dose given on the morning of second postoperative day.
15991920|NCT02950220|Drug|Ibrutinib|Given PO
15991921|NCT02950220|Other|Laboratory Biomarker Analysis|Correlative studies
15991922|NCT02950220|Biological|Pembrolizumab|Given IV
15991923|NCT02950207|Genetic|miRNA|miRNA extraction
15991924|NCT02950194|Procedure|PPAWI|One-step procedure of a panniculectomy performed by a plastic surgeon together with a mesh augmentation of the abdominal wall by a general surgeon.
15991925|NCT02950181|Device|NIRS|Correlating the NIRS/Cerebral Oximetry readings to the various critical ill and injured pediatric patients, trends, interventions, and outcomes
15991926|NCT02950168|Procedure|Edoxaban|Edoxaban according to Summary of Product Characteristic (SMPC)
15991927|NCT02950155|Drug|Rituximab|A single infusion at a dose of 500 mg Mabthera/Rituximab.
15991928|NCT02950155|Drug|Sodium Chloride solution|A single infusion of Placebo/Sham.
15991929|NCT02950142|Other|CPOE with order sets for lab testing|CPOE including series of recommended tests ordered per indication
15991930|NCT02950142|Other|CPOE without order sets for lab testing|CPOE only
15991931|NCT02950129|Other|SIJ pain diagnostic tests|The subjects will undergo a specific physical exam of tests reported to be diagnostic of sacroiliac joint (SIJ) pain prior to receiving the routine injection in the SIJ; all tests will be repeated after the SIJ injection
15991932|NCT02950116|Device|Perform three multiple breath nitrogen washout tests (N2-MBW-test)|"Patient is sitting in upright position, nose clip in place and breathing through a mouth piece with filter (neither sitting forward with back bent, nor supporting arms such that shoulders are raised)
~Patient's breathing pattern is stable for a minimum of 5 breaths
~Start of washout by inhaling 100% oxygen (initiated by lab technician)
~Continuous stable breathing pattern until end of washout test
~End target = 1/40th of start N2 concentration
~To ensure end of washout is achieved, patients should breathe 5 more breaths below the target concentration before the trial is terminated
~Three N2-MBW-tests are performed consecutively. Time between each test is [duration of the previous test*1.5] (e.g. test duration = 6 min., time to next test = 6*1.5 = 9 min.)"
15991933|NCT02950103|Drug|Phosphoethanolamine|Phosphoethanolamine PO daily
15991934|NCT02950090|Behavioral|MobilWise|see arm description for MobilWise above
15991935|NCT02950090|Behavioral|Fitbit Only|see arm description for Fitbit above
15991936|NCT02950077|Behavioral|mindfulness based stress reduction|The intervention will be delivered in a group setting and the group will meet for 2 hours once per week for 8 weeks. The intervention is based on new neuroscience of stress and resilient adaptive behaviors, mindfulness based stress reduction, therapeutic breath and synchronized yogic movement with a focus on the lower abdomen, integrated with cognitive and behavioral strategies for self-control and healthy decision making.
15991937|NCT02950064|Drug|BTP-114|"Part 1 (Escalation) IV treatment of BTP-114 in 21-day cycles. Doses will be increased in sequential cohorts until the maximum tolerated dose is determined which will lead to the recommended phase 2 dose
~Part 2 (Expansion) 5 cohorts of patients will be treated at the RP2D of IV BTP-114 in 21-day cycles for the tumor types pancreatic cancer, castration-resistant prostate cancer, ovarian cancer, triple-negative breast cancer and deoxyribonucleic acid (DNA) repair mutation-positive advanced solid tumors."
15991938|NCT02950051|Drug|Fludarabine|Fludarabine i.v.: cycles 1-6: 25 mg/m², d1-3, q28d
15991939|NCT02950051|Drug|Cyclophosphamide|Cyclophosphamide i.v.: cycles 1-6: 250 mg/m², d1-3, q28d
15991940|NCT02950051|Biological|Rituximab|Rituximab i.v. (before chemotherapy): cycle 1: 375 mg/m², d0; cycles 2-6: 500 mg/m², d1; q28d
15991941|NCT02950051|Drug|Bendamustine|Bendamustine i.v.: cycles 1-6: 90mg/m², d1-2, q28d
15991942|NCT02950051|Drug|Venetoclax|"Venetoclax p.o. (ramp-up: dose escalation until final dose is reached)
~cycle 1: 20 mg (2 tabl. at 10 mg), d22-28, q28d
~cycle 2: 50 mg (1 tabl. at 50 mg), d1-7; 100 mg (1 tabl. at 100 mg), d8-14; 200 mg (2 tabl. at 100 mg), d15-21; 400 mg (4 tabl. at 100 mg), d22-28, q28d
~cycles 3-12: 400 mg (4 tabl. at 100 mg), d1-28, q28d"
15991943|NCT02950051|Biological|Obinutuzumab|"Obinutuzumab i.v.
~cycle 1: 100 mg, d1; 900 mg, d1(2); 1000 mg, d8+15, q28d
~cycles 2-6: 1000 mg, d1, q28d"
15991944|NCT02950051|Drug|Ibrutinib|"Ibrutinib p.o.
~cycles 1-12: 420 mg, d1-28, q28d
~cycles 13-36: 420 mg, d1-28, q28d"
15991945|NCT02950038|Drug|Ibrutinib|560 mg given by mouth daily in a 28 day cycle.
15991946|NCT02950038|Drug|Nivolumab|3 mg/kg by vein beginning with Cycle 2 on Days 1 and 15 of every 28 day cycle.
15991947|NCT02950025|Device|Online, adaptive MR-guided SBRT|Patients randomized to the online-adaptive treatment planning arm will have all tumor volumes and critical structures within 3 axial slices of the PTV re-contoured on the MR-localization image of the day. The estimated delivered dose should be calculated using the software on the console. An adapted radiation therapy plan should be generated
15991948|NCT02950025|Device|Online, non-adaptive MR-guided SBRT|Patients will not have online-adaptive treatment planning
15991949|NCT02950025|Other|European Organization for Research and Treatment of Cancer (EORTC) QLQ-30|"30 questions
~28 questions about various health issues with answers ranging from 1=Not At All to 4 = Very Much
~1 question asking about overall health with answers ranging from 1=very poor to 7 excellent
~1 question asking about overall quality of life with answers ranging from 1=very poor to 7=excellent"
15991952|NCT02949999|Drug|Voclosporin|
15991953|NCT02949986|Behavioral|Tablet-based Fall Prevention|The focus of the Otago Exercise Program is on improving strength and balance with a home-based balance exercise program. The program will be self-administered via tablet-based version of the Otago fall prevention program. Participants will complete 2 months of the home-based balance exercise program using the Health in Motion app. Participants will be asked to perform the exercises for 30 minutes 3x/week. Participants will be asked to perform the exercise program for 2 months.
15991954|NCT02949973|Drug|voclosporin|
15991955|NCT02949960|Drug|DMT210 Topical Gel|DMT210 Topical Aqueous Gel 5% applied twice daily
15991956|NCT02949960|Drug|Vehicle Control|Topical Vehicle Gel applied twice daily
15991957|NCT02949947|Drug|Ferric Carboxymaltose|15 mg/kg by vein (up to 750 mg) over 15 min infusion. Dose repeated 1 week later.
15991958|NCT02949947|Dietary Supplement|Iron Supplements|Participants take iron supplements by mouth every day for up to 3 months.
15991959|NCT02949947|Behavioral|Questionnaire|Health questionnaire completed at Baseline and at Weeks 4, 8, 12, and 24.
15991960|NCT02949934|Drug|Tolcapone|
15991961|NCT02949934|Drug|Placebo|
15991962|NCT02949921|Device|Radiesse injectable implant and 2% lidocaine HCL|Radiesse injectable implant injected in small boluses (0.2-0.5cc/bolus). No more than 0.5cc per bolus. No more than 3 cc (2 syringes) will be injected per hand.
15991963|NCT02949908|Drug|Rebif|Participants diagnosed with RRMS who had discontinued their oral or injectable first-line multiple sclerosis (MS) medication, and have been receiving subcutaneous Interferon beta-1a (IFNβ-1b) (Rebif) were observed during the study. Participants received Rebif in accordance with the licensed Summary of Product Characteristics label or currently approved specific country product information.
15991967|NCT02949882|Dietary Supplement|Yakult|Containing at least 6,5*10^9 colony forming units (cfu) of Lactobacillus casei Shirota (LcS)
15991968|NCT02949882|Dietary Supplement|Dairy Peach Drink (AH Basic)|Commercially available dairy drink with peach flavour.
15991969|NCT02949869|Other|Spinal Sonography|As described previously
15991970|NCT02949856|Device|Mallinckrodt, COVIDIEN|
15991971|NCT02949856|Device|Endotracheal tube, Unomedica|
15991972|NCT02949843|Drug|Chemotherapy|Receive other treatment
15991973|NCT02949843|Biological|Immunotherapy|Receive other treatment
15991974|NCT02949843|Other|Laboratory Biomarker Analysis|Correlative studies
15991975|NCT02949843|Biological|Nivolumab|Given IV
15991976|NCT02949843|Biological|Pembrolizumab|Given IV
15991977|NCT02949843|Drug|Targeted Molecular Therapy|Receive drug targeting secondary mutation
15991978|NCT02949843|Drug|Tyrosine Kinase Inhibitor|Given PO
15991980|NCT02949817|Device|digital rehabilitation system with wearable multi-IMU(inertial measurement unit) sensors (Rapael kids)|1.The Rapael kids, a video-game based rehabilitation therapy system using IMU sensors as a game interface, newly-developed in Korea will be used on upper limb function of children with pediatric brain injury patients. 20 of All 40 children will receive the conventional occupational therapy and additional video-game based rehabilitation therapy, 30 minutes daily 5 times per week, for 4 weeks.
15991981|NCT02949817|Other|Conventional OT group|2. Conventional OT group will recieve the conventional occupational therapy and one more conventional occupational therapy additionally. The additional occupational therapy training will be performed 30 minutes daily 5 times per week, for 4 weeks.
15991982|NCT02949804|Behavioral|Comparison between two groups|Comparison will be made between smokers and non smokers regarding vasovagal tendency
15991983|NCT02949791|Procedure|Cytoreductive surgery|Maximal surgical effort to obtain a minimal residual disease of less than 2.5 mm
15991984|NCT02949791|Other|Low Intra abdominal pressure HIPEC|Hyperthermic intraperitoneal chemotherapy using closed modality and intra abdominal pressure of 8-12 mmHg
15991985|NCT02949791|Other|High Intra abdominal pressure HIPEC|Hyperthermic intraperitoneal chemotherapy using closed modality and intra abdominal pressure of 18-22 mmHg
15991986|NCT02949778|Procedure|QL-block|Bilateral quadratus lumborum block using either ropivacaine 3.75mg/ml or sodium chloride 0.9% is the intervention studied
15991987|NCT02949778|Drug|Ropivacaine|Ropivacaine 3.75mg/ml administered in QL-block as active treatment
15991988|NCT02949778|Drug|Sodium Chloride|Sodium chloride 9mg/mL administered in QL-Block as placebo
15991989|NCT02949765|Drug|Iron sulfate 105 mg|Daily supplementation with iron sulfate 105 mg 1 pill/day
15991990|NCT02949765|Dietary Supplement|Iron-rich diet|
15991991|NCT02949752|Drug|Aripiprazole|Aripiprazole 5 mg every morning will be prescribed for 12 weeks
15991992|NCT02949739|Behavioral|Intensive lifestyle modification|The intervention is delivered as 9 face-face and 13 telephone contact sessions over 12 months. Index cases are the focus for the intervention, but lifestyle modification encourages the whole family to adopt healthy living.
15991993|NCT02949726|Drug|Indocyanine Green (ICG)|"Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) using Indocyanine Green (ICG) is used to visualize lymphatic vessel anatomy and function."
15991994|NCT02949726|Device|Near-infrared Fluorescence Lymphatic Imaging (NIRFLI)|"Near-infrared Fluorescence Lymphatic Imaging (NIRFLI) using Indocyanine Green (ICG) is used to visualize lymphatic vessel anatomy and function."
15991995|NCT02949713|Behavioral|Text messaging-motivational interviewing|Interactive weekly mobile phone text messaging plus prospective motivational interviews
15991996|NCT02949700|Drug|Metformin|Metformin will be administered orally twice daily during treatment with chemo-radiation for head and neck squamous cell carcinoma. This will occur 7 to 11 days prior to chemotherapy and radiation.
15991997|NCT02949687|Procedure|ileal interposition with sleeve and sympathectomy|laparoscopic ileal interposition with sleeve and sympathectomy
15991998|NCT02949674|Drug|Ropivacaine|It will be used as a analgesic dose in surgical site before surgery.
15991999|NCT02949674|Drug|Bupivacaine|It will be used as a analgesic dose in surgical site before surgery.
15992000|NCT02949661|Procedure|Superficial cervical plexus block|Patients will receive bilateral superficial cervical plexus block
15992001|NCT02949661|Procedure|Local wound infiltration|Patients will receive local wound infiltration
15992002|NCT02949648|Device|Electronic cigarette|Electronic cigarettes are devices that do not burn or use tobacco leaves but instead vaporize a solution the user then inhales. The device contains an electronic vaporization system, rechargeable batteries, electronic controls and cartridges of the liquid is vaporized.
15992003|NCT02949622|Behavioral|Multimodal intervention program|"The intervention is structured as follows:
~Review of previous session (20 min) Agenda and goals (5 min) Presentation of the topic to be worked (15 min) Training (60 min) Summary and feedback (15 min)"
15992004|NCT02949622|Other|Lifestyle counseling|The group of lifestyle counseling will have basic guidelines, according to the recommendations of public health.
15992005|NCT02949609|Other|Mirror Therapy|Mirror therapy will consist in placing a large mirror in the sagittal plane of the subject so as to reflect his healthy arm while hiding the paretic one, and then asking him to perform movements of his healthy arm while looking at its reflection in the mirror.
15992006|NCT02949609|Other|Control Therapy|Performance of the same movements as the experimental group without the mirror or instructions as to where to look, 5 days/week, for 4 weeks.
15992007|NCT02949596|Behavioral|Quality of life and quality of sexual life questionnaires|
15992008|NCT02949583|Drug|Punica granatum Linn.|Mouthwash (6,25% of Punica granatum Linn) 10mL per day during 14 days
15992009|NCT02949583|Drug|chlorhexidine|standard anti-bacterial mouthwash Mouthwash (0,12% chlorhexidine) 10mL per day during 14 days
15992010|NCT02949570|Drug|Inecalcitol|Prospective open label, non-comparative, multicentre exploratory study. Divided in 2 parts Part1: Inecalcitol treatment will be added to imatinib for 12 months. Part 2: Follow-up after discontinuation of inecalcitol. Imatinib will be maintained for 2 years and then will be stopped for those still in MR4.5. These patients will then be followed for 2 additional years after discontinuation of imatinib.
15992011|NCT02949557|Procedure|Decortication + bone grafts|
16004099|NCT02858284|Device|Sham|
15992014|NCT02949518|Other|Enhanced Recovery Pathway (ERP) for Spine|The study team emphasizes that all components of the ERP are considered standard of care at this institution. The objective of this study is to ensure that the study patients assigned to the ERP will receive these standard of care components.
15992015|NCT02949505|Behavioral|Home prehabilitation program|12-week exercise therapy using daily step program (accelerometer), functional resistance exercise sessions and telephone/virtual clinic appointments
15992016|NCT02949492|Drug|IL-2 (interleukin 2)|Low-dose IL-2 will be initiated while study participants remain on a calcineurin inhibitor immunosuppressant. Following 4 weeks of treatment, participants showing at least a 2-fold increase in peripheral blood absolute Treg numbers, stable liver function and no adverse effects will undergo a liver biopsy to exclude sub-clinical graft damage, and subsequently will initiate immunosuppression withdrawal. Low-dose IL-2 will be maintained for a total of 6 months.
15992017|NCT02949479|Behavioral|Dissociation Investigation in Sex Offenders|prevalence of a clinical dissociative state during the offence; secondary : correlations of dissociation with childhood abuse or neglect, with significant lifetime dissociative experience, post traumatic stress disorder or dissociative disorder (DSM-5), violence and sexual estimated risk using actuarial and professional structured judgement tools
15992018|NCT02949466|Drug|Triamcinolone|compare the additional therapeutic effects of triamcinolone combined with hyaluronic acid injections to hyaluronic acid injections only to patients with knee osteoarthritis
15992019|NCT02949466|Device|Hyaluronic acid|compare the additional therapeutic effects of triamcinolone combined with hyaluronic acid injections to hyaluronic acid injections only to patients with knee osteoarthritis
15992020|NCT02949453|Behavioral|Semi-directed interview performed by a social sciences researcher|"Two semi-directed interviews performed by social sciences researcher:
~first interview performed 6 weeks after the suicide attempt, in an suicide prevention unit, duration 1 to 1.5 hour
~second interview performed 3 month after the suicide attempt, in a suicide prevention unit, duration 1 to 1.5 hour"
15992021|NCT02949440|Procedure|the caudal-to-cranial approach|Cutting the peritoneum along the line between the right mesocolon and retroperitoneum, enter the Toldt's space to dissect the posterior of Superior mesenteric vein and Superior mesenteric artery and their branches, and then finished the D3 dissection from caudal to cranial on both sides of the mesentery along the Superior mesenteric vein. In the end, cut the lateral ligament to mobilize the posterior space of ascending colon. This approach is called the caudal-to-cranial approach.
15992022|NCT02949440|Procedure|the medial-to-lateral approach|First, the pedicle of ileocolic vessels is identified and the mesocolon is dissected between the pedicle and the periphery of the Superior mesenteric vein to expose the second portion of the duodenum. The ileocolic vessels are then cut at their roots. The ascending mesocolon is separated from the retroperitoneal tissues, duodenum, and pancreatic head up to the hepatocolic ligament cranially. The important detail in this procedure is the wide separation between the pancreatic head and the transverse mesocolon.This approach is the medial-to-lateral(MtL) approach
15992023|NCT02949414|Procedure|Cadaveric decellularised tracheal scaffold seeded with autologous mesenchymal cells|The tracheal graft will be manufactured from cadaveric tracheal scaffold and bone marrow derived mesenchymal cells.
15992024|NCT02949401|Behavioral|Use of Virtual Reality App|The VR app will consist of relaxation techniques as well as a virtual tour of the hospital (pre-op area, IV placement, cath lab, and post-op area).
15992025|NCT02949388|Drug|Placebo|Two capsules (both containing Placebo enclosed) taken twice a day and approximately 12 hours apart
15992026|NCT02949388|Drug|400 mg (200 mg BID)|Two capsules (both containing two 50mg tablets enclosed) taken twice a day and approximately 12 hours apart
15992027|NCT02949388|Drug|300 mg (150 mg BID)|Two capsules (one containing 50mg tablet and one containing two 50 mg tablets) taken twice a day and approximately 12 hours apart
15992028|NCT02949375|Drug|Placebo Comparator|Placebo gel capsule to be taken daily for 28 days
15992029|NCT02949375|Drug|Active Comparator:4.5mg GRI-0621|4.5mg GRI-0621 gel capsule to be taken daily for 28 days
15992030|NCT02949375|Drug|Active Comparator: 6.0mg GRI-0621|6.0mg GRI-0621 gel capsule to be taken daily for 28 days
15992031|NCT02949362|Drug|Teduglutide|0.05mg/kg
15992032|NCT02949362|Other|SOC|Standard safety assessments and adjustments in nutritional support will be provided for all subjects throughout the study, including any teduglutide treatment periods
15992033|NCT02949349|Drug|Mycophenolate mofetil|Provided as 250mg/capsule, dose specific for each arm, orally twice a day, for 24 weeks.
15992034|NCT02949349|Drug|Azathioprine|Provided as 50mg/tablet, 1mg/kg, orally twice a day, for 24 weeks.
15992035|NCT02949349|Drug|Prednisolone|Daily dose not more than 10mg, orally, for 24 weeks.
15992036|NCT02949336|Radiation|Observational use of fluoroscopy|Minimal radiation exposure (0.17 mSv) for observational purpose
15992037|NCT02949323|Other|urinary stone|patients of group one have urinary stones
15992038|NCT02949310|Drug|Nefopam|
15992039|NCT02949310|Drug|Normal Saline|
15992040|NCT02949297|Device|Ovation Alto Abdominal Stent Graft System|Repair of Abdominal Aortic Aneurysm with Ovation Alto Abdominal Stent Graft System
15992041|NCT02949284|Drug|Abiraterone Acetate|Given PO
15992042|NCT02949284|Drug|Androgen Receptor Antagonist ARN-509|Given PO
15992043|NCT02949284|Biological|Gonadotropin-releasing Hormone Analog|Given SC
15992044|NCT02949284|Drug|Prednisone|Given PO
15992045|NCT02949284|Other|Quality-of-Life Assessment|Ancillary studies
15992046|NCT02949284|Other|Questionnaire Administration|Ancillary studies
15992047|NCT02949284|Procedure|Radical Prostatectomy|Undergo radical prostatectomy
15992048|NCT02949271|Other|Programmed Intermittent Epidural Bolus|
15992049|NCT02949271|Other|Continuous Epidural Infusion|
15992050|NCT02949271|Drug|Ropivacaine|
15992051|NCT02949271|Drug|Fentanyl|
15992052|NCT02949258|Drug|oxaliplatin|oxaliplatin 150 mg will be administered from the celiac artery on day 1 of every cycle in all cases
15992053|NCT02949258|Drug|etoposide|etoposide 100 mg will be administered from the celiac artery on day 1 of every cycle in all cases
15992054|NCT02949258|Drug|epirubicin|epirubicin 30 mg will be administered from the celiac artery on day 1 of every cycle in all cases
15992055|NCT02949258|Drug|S1|Oral S-1 120 mg per day will be administered on days 1-14 of every cycle in all cases
16006269|NCT02840929|Drug|Esomeprazole|
15992056|NCT02949245|Procedure|Interventions|"Procedure/Surgery: Routinely performed surgical correction of spinal deformity
~Routinely performed surgical correction of spinal deformity"
15992057|NCT02949232|Drug|Prednisolone|prednisolone will be will be initiated during the first week at 40mg/day for 3 days and 30mg/day for 4 days, followed by a decrease of 5mg/day per week during the remaining 5 weeks; in the second week, patients will use 25 mg/day, in the third week 20 mg/day is used etc. In the last week the patients will only take prednisolone on day 1-3 and day 5 and 7; a tapering scheme in line with the treatment guidelines for Inflammatory Bowel Diseases (2008).
15992058|NCT02949232|Drug|Placebo Oral Tablet|Dosing following the tapering scheme of the treatment of the treatment arm
15992059|NCT02949219|Other|Laboratory Biomarker Analysis|Correlative studies
15992060|NCT02949219|Biological|Pembrolizumab|Given IV
15992061|NCT02949206|Drug|JNJ-64179375|During part 1, participants will receive a single ascending Intravenous dose of JNJ-64179375 ranging from (0.03 mg/kg to 5.0 mg/kg). In Part 2, participants will receive a 2.5 mg/kg or highest tolerable dose if lower than 2.5 mg/kg of JNJ-64179375. In Part 3, participants will receive a Single Subcutaneous (SC) dose of 1.0 mg/kg or highest tolerable dose if less than 1.0 mg/kg of JNJ-64179375.
15992062|NCT02949206|Drug|Placebo|Participants will randomly receive matching placebo in all 3 Parts on day 1 administered via IV Route (for Part 1 and 2) and SC route (for Part 3).
15992063|NCT02949206|Drug|4 Factor Prothrombin Complex Concentrate (PCC)|Following a single dose of JNJ-64179375, participants will receive a single IV dose of 4 factor-PCC.
15992064|NCT02949193|Drug|evogliptin|evogliptin 5mg tablet qd + placebo tablet matching to sitagliptin 100mg
15992065|NCT02949193|Drug|Sitagliptin|sitagliptin 100 mg tablet qd + placebo tablet matching to evogliptin 5mg
15992066|NCT02949180|Device|Five minutes puls wave recording|iPhone will be positioned on the index finger for five minutes to record a pulse wave
15992067|NCT02949167|Behavioral|MyHealth|The MyHealth intervention is a nurse-led individually tailored symptom management program, focused on patient education and regularly collection of Patient Reported Outcomes (PRO) subsequently evaluated by specialist nurses and navigation to health care service. The nurse will meet with the patient on three-five planned appointments focused on adjustment of life after breast cancer treatment including information on symptoms of relapse or late effects and how to react on these. Close relatives are invited if patients accept. Patients will report PRO´s on symptoms of recurrence and late effects every three months during the first year and thereafter every six months.The appointments with the nurse are finalized within 3-6 month and patients will be followed with PRO for three years.
15992068|NCT02949141|Device|Lung Ultrasound|All patients will receive lung ultrasound, chest x-ray and computed tomography
15992069|NCT02949141|Device|Chest X-ray|All patients will receive chest x-ray as per usual care for evaluation for pneumonia
15992070|NCT02949141|Device|Chest Computed Tomography (CT)|All enrolled patients will receive a CT scan as the gold standard for diagnosing pneumonia
15992071|NCT02949128|Biological|Ravulizumab|Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight: ≥ 40 to < 60 kilograms (kg), 2400 milligrams (mg) loading, then 3000 mg every 8 weeks; ≥ 60 to < 100 kg, 2700 mg loading, then 3300 mg every 8 weeks; ≥ 100 kg, 3000 mg loading, then 3600 mg every 8 weeks.
15992072|NCT02949115|Dietary Supplement|70 mL red beetroot juice|1x daily intake of 70 mL red beetroot juice
15992073|NCT02949115|Dietary Supplement|70 mL red beetroot juice without nitrate|1x daily intake of 70 mL red beetroot juice without nitrate
15992074|NCT02949115|Dietary Supplement|70 mL placebo drink plus potassium nitrate|1x daily intake of 70 mL placebo control drink plus 489 mg potassium nitrate (300 mg nitrate)
15992075|NCT02949115|Dietary Supplement|70 mL placebo drink|1x daily intake of 70 mL placebo control drink
15992076|NCT02949102|Dietary Supplement|Crave Crush|Crave Crush is a dietary supplement that affects sweet taste receptors on the tongue.
15992077|NCT02949102|Dietary Supplement|Placebo|The placebo tablet is comparable in taste and is comprised primarily of sorbitol.
15992078|NCT02949089|Drug|ACH04|The subjects will receive the study medication in each group
15992079|NCT02949076|Behavioral|Exercise|Unilateral lower limb resistance exercise will be performed 3 times per week for 8 weeks in non-small cell lung cancer patients on only one leg, while the contralateral leg serves as a non-exercising control.
15992080|NCT02949063|Behavioral|Comfortable Cafeteria Program|6-week program integrated into the cafeteria lunchtime to build capacity of supervisors and students to create a positive social and emotional atmosphere so that students can enjoy eating their lunch and socializing with peers.
15992081|NCT02949050|Biological|subcutaneous allergen immunotherapy (SCIT)|20 patients who (prior to study enrollment and initiation) completed more than 1 year of timothy grass SCIT vs. 20 control patients who underwent corn pollen exposure for for greater than one year during the same prestudy time interval. Efficacy will be assessed by analyses of symptom score surveys and quality of life surveys.
15992082|NCT02949050|Biological|SCIT|Treatment group consists of patients who completed > 1 year of SCIT while control group patients did not undergo SCIT
15992083|NCT02949037|Other|Mobile Health Care Environment (MHCE)|An integrated mobile health system modified to support type 2 diabetes self-care activities. Primary intervention includes visualization and trending of device outcomes AND tailored behavioral messages based on Patient Activation Measure scores.
15992084|NCT02949024|Drug|IVT Aflibercept|IVT aflibercept [2 mg (50 µL)]
15992085|NCT02949024|Drug|SC CLS-TA|[4 mg (100 µL)]
15992086|NCT02949011|Drug|Baloxavir Marboxil|Tablets taken orally
15992087|NCT02949011|Drug|Placebo to Baloxavir Marboxil|Matching tablets taken orally
15992088|NCT02949011|Drug|Oseltamivir|Capsules taken orally
15992089|NCT02949011|Drug|Placebo to Oseltamivir|Matching placebo capsules taken orally
15992090|NCT02948998|Drug|Spironolactone|The participants in this arm will be prescribed to take 20mg spironolactone orally and daily. Serum potassium concentration and creatinine and blood pressure will be monitored regularly to make the participants safe.
15992158|NCT02948322|Procedure|OGTT|Growth Hormon (GH) secretion and metabolic status of the acromegalic will be evaluated by an measure of plasma glucose, insulin and GH (OGTT), and insulin-like growth factor-1 (IGF-I) will be measured in patients and healthy volunteers.
15992159|NCT02948309|Drug|Mistletoe extract (Iscador Qu)|1ml subcutaneous injection 3 times/week, dose escalation 0,01mg - 20mg
16006496|NCT02839226|Drug|AR/101|
15992091|NCT02948985|Other|treated with FOLFIRI±cetuximab|Peripheral blood samples of 10 mL were collected from the patients for CTCs analysis and tumor marker in every cycle D0 and D8. Tumor response evaluation will be performed after four cycles of chemotherapy by CT/MRI based on RECIST. Clinical data, including tumor stage, metastatic organ, objective response, progression free survival, overall survival, etc, will be collected according to study protocol.The correlation of the RAS status on CTCs and the mutant gene in ctDNA to the therapeutic response will be evaluated.
15992092|NCT02948972|Procedure|complete surgery|complete surgery of colorectal deep infiltrating endometriosis
15992093|NCT02948972|Procedure|In vitro fertilization without surgery|IVF without endometriosis surgery
15992098|NCT02948946|Procedure|NETest|5 mL of blood will be drawn from participants for testing.
15992099|NCT02948920|Drug|Ephedrine|9 mg of ephedrine (3 ml)
15992100|NCT02948920|Drug|NSS|3 ml of normal saline
15992101|NCT02948907|Other|Procedure/Bronchoscopy|"Patients with enlarged hilar and/or mediastinal lymph nodes and indication for EBUS-TBNA undergo diagnostic bronchoscopy. For characterisation of the enlarged lymph nodes endobronchial ultrasound with elastography and Tissue Harmonic Imaging (THI) are used. Afterwards, EBUS-TBNA is performed. The results of elastography and THI are correlated with the cytological result obtained by EBUS-TBNA."
15992102|NCT02948894|Device|Mandibular advancement device|an oral appliance (a dental device) for obstructive sleep apnea
15992103|NCT02948881|Drug|ibandronate|
15992104|NCT02948842|Drug|Clostridium Histolyticum Collagenase|0.08ml of XIAFLEX® (0.58 mg of XIAFLEX® mixed with 0.39 mL of sterile diluent) in a single location within the stricture, chased by an additional 0.25 mL of reconstituted XIAFLEX® to allow for clearance of the original 0.08 mL of reconstituted XIAFLEX® from the transurethral syringe into the urethral stricture. This is based on 0.25 mL residual fluid that remains within the lumen of the injeTAK syringe. Thus, by adding the additional 0.25 mL of XIAFLEX® as a chase, we are expecting the original total of 0.08 mL of XIAFLEX® to be injected into the area of scarring.
15992105|NCT02948842|Other|Saline|0.08ml of injectable normal saline
15992106|NCT02948829|Biological|TDV|TDV SC injection.
15992107|NCT02948816|Behavioral|Facebook|Participants will spend 30 minutes on a Facebook page that is primarily non-food related posts.
15992108|NCT02948816|Behavioral|Facebook + Food|Participants will spend 30 minutes on a Facebook page that is food related posts.
15992109|NCT02948816|Behavioral|Colouring|Participants will spend 30 minutes colouring quietly.
15992110|NCT02948803|Behavioral|smartphone based intervention with Active Coach app|
15992114|NCT02948764|Device|Vacuum-Assisted Biopsy|The vacuum-assisted (7-10G), minimal invasive biopsy (VAB), either guided by ultrasound, or by mammography (stereotaxy) during the second trial visit (V2) will be performed once. In analogy to the German S3 guideline on primary breast cancer management we recommend to take at least 12 biopsies with 10G needles or less in case of larger needle sizes.
15992115|NCT02948738|Behavioral|Interactive Asthma Education|Active participation to develop asthma action plan and teach back cycles for asthma inhaler teaching/training
15992116|NCT02948738|Behavioral|Standard Asthma Education|Basic review of asthma action plan and inhaler use
15992117|NCT02948725|Other|Cross-education + standard rehabilitation|
15992118|NCT02948712|Behavioral|Distress Screening Thermometer|Screening took with an overall distress ranging from 0-10 and additional stress items in the areas of practical problems, family problems, emotional problems, spiritual or religious concerns, and physical problems
15992119|NCT02948712|Behavioral|NCCN Guidelines: Distress management|Based on the NCCN Guidelines Version 1.0.2016 which recommend brief screening, evaluation, and treatment of distress
15992120|NCT02948699|Dietary Supplement|Nutrison|Nutrison(400-600ml/d) will be given to Arm 1 patient between regular diet. When the daily ration was cut down to 50%,100ml/h Nutrison was added. When grade Ⅲ-Ⅳ oral mucositis appeared, total Nutrison was applied to patients by NG or PEG.
15992121|NCT02948686|Other|Self-Etching Application Strategy|In Group SET, the adhesive system Ambar Universal will be used in 55 teeth, according to the manufacturer's instructions, in the self-etching mode. The adhesive system will be brushed during 10 seconds in the cavity, will be air-dried during 5 seconds, brushed again during 10 seconds, air-dried during 10 seconds and activated during 10 seconds with LED light; After applying the adhesive, the restorations will be made with composite resin Opallis (FGM, Joinville, Brazil), and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores.
15992122|NCT02948686|Other|Enamel Etching Application Strategy|In Group SEE, 37% phosphoric acid will be applied during 15 seconds, only in enamel in 55 teeth. This acid will be removed using water, the cavity will be air-dried, and then, the adhesive system Ambar Universal will be brushed during 10 seconds in the cavity, will be air-dried during 5 seconds, brushed again during 10 seconds, air-dried during 10 seconds and activated during 10 seconds with LED light; After applying the adhesive, the restorations will be made with composite resin Opallis (FGM, Joinville, Brazil), and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores.
15992123|NCT02948686|Other|Self Etching with Extended time Application Strategy|In Group SETT, the adhesive system Ambar Universal will be used in 55 teeth, in the self-etching mode. The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, brushed again during 20 seconds, air-dried during 10 seconds and activated during 10 seconds with LED light; After applying the adhesive, the restorations will be made with composite resin Opallis (FGM, Joinville, Brazil), and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores
15992160|NCT02948309|Drug|Placebo|1ml subcutaneous injection 3 times/week
15992124|NCT02948686|Other|Self Etching with Extended layers number Strategy|In Group SETL, the adhesive system Ambar Universal will be used in 55 teeth, in the self-etching mode. The adhesive system will be brushed during 10 seconds in the cavity, will be air-dried during 5 seconds, brushed again during 10 seconds, air-dried during 5 seconds, brushed again during 10 seconds, air-dried during 5 seconds, brushed again during 10 seconds, air-dried during 5 seconds, and activated during 10 seconds with LED light; After applying the adhesive, the restorations will be made with composite resin Opallis (FGM, Joinville, Brazil), and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores
15992125|NCT02948673|Dietary Supplement|Glutathione|4 oral GSH tablets/day (1000mg/day) for 4 weeks
15992126|NCT02948673|Other|Placebo|4 oral placebo tablets for 4 weeks
15992127|NCT02948660|Other|zolpidem tartrate|
15992128|NCT02948660|Other|melatonin|
15992129|NCT02948647|Other|Standard of care plus sugar-reduction education|This is a 12-week intervention where subjects will be educated on how to monitor their added sugar consumption. They will be asked to eliminate consumption of sweetened beverages for the 12-week period and will be receiving a weekly delivery of water bottles to their homes to displace the sweetened beverages in their home environment.
15992130|NCT02948634|Device|Sham Phoenix Laser Treatment|Sham treatment will be delivered via the same protocol in terms of time, application, and areas of treatment as stated above, except the laser unit will not discharge any photonic energy. Intervention will take place in the therapy room at the McDermott Center for Pain Management, which is appropriately equipped for laser administration. Application of therapeutic laser will be completed by licensed physical therapists who have completed safety training for therapeutic laser application including appropriate use of safety eyewear, room access, laser signage for laser use, and patient monitoring.
15992131|NCT02948634|Device|Active Phoenix Laser Treatment|The 30 min treatments will include multiple 60 sec applications to all tender points on the spine or extremities and a 10 minute application along the bilateral sympathetic ganglion in the paraspinous region. The treatment will be applied via a non-contact method, with the laser applicator held 12-18 inches above the participant's skin.
15992132|NCT02948621|Procedure|Endoscopic sleeve gastroplasty|Endoscopic sleeve gastroplasty is performed using a CE marked endoscopic suture device (Overstitch, Apollo Endosurgery, Austin, Tx. USA). Continuous stitches are placed to create a sleeve-shaped gastric path of 2 cm diameter to reduce stomach volume from the proximal antrum to the oeso-gastric junction.
15992133|NCT02948595|Other|Video feedback followed by structured verbal feedback|Video feedback followed by structured verbal feedback
15992134|NCT02948595|Other|Structured verbal feedback followed by video feedback|Structured verbal feedback followed by video feedback
15992135|NCT02948582|Drug|Glycopyrrolate Inhalation Solution12.5μg|Glycopyrrolate Inhalation Solution12.5μg via eFlow, once daily
15992136|NCT02948582|Drug|Glycopyrrolate Inhalation Solution 50μg|Glycopyrrolate Inhalation Solution 50μg via eFlow, once daily
15992137|NCT02948582|Drug|Glycopyrrolate Inhalation Solution 100μg|Glycopyrrolate Inhalation Solution 100μg via eFlow, once daily
15992138|NCT02948582|Drug|Glycopyrrolate Inhalation Solution 200μg|Glycopyrrolate Inhalation Solution 200μg via eFlow, once daily
15992139|NCT02948582|Drug|Glycopyrrolate Inhalation Solution 400μg|Glycopyrrolate Inhalation Solution 400μg via eFlow, once daily
15992140|NCT02948582|Drug|Placebo 0.5mL|Placebo 0.5mL via eFlow, once daily
15992141|NCT02948569|Drug|3-V Bioscience-2640|Subjects will take a singly daily dose of 3-V Bioscience-26400 before bedtime or 22:30, whichever comes first, for 10 days.
15992142|NCT02948543|Biological|Bacillus of Calmette-Guerin (BCG)|A strain of tubercle bacillus which modifies biologic response.
15992143|NCT02948543|Drug|Mitomycin C (MMC)|An antibiotic produced by a soil actinomycete which inhibits DNA synthesis.
15992144|NCT02948517|Other|Time restricted feeding|Time restricted feeding
15992145|NCT02948504|Procedure|Coiling or Clipping|All patients are treated under general anesthesia and systemic heparinization. A bolus of 50-75 IU/kg of heparin is given after femoral sheath placement, and intermittent boluses of 1250 IU per hour are given during the procedure. Activated clotting time is maintained at 2-3 times baseline level. Balloon-assisted coiling or stent-assisted coiling are considered in aneurysms with an unfavorable morphology (aneurysm neck≥ 4.0 mm or dome/neck ≤2.0). All anterior circulation aneurysms are clipped through a standard pterional or frontal temporal approach. The posterior circulation aneurysms are treated using far lateral approach depending on the aneurysm location.
15992146|NCT02948491|Other|Music therapy|Song that the mother sings to the child before birth, recording of the mother's voice.
15992147|NCT02948478|Other|Exposed|Precarious patients
15992148|NCT02948478|Other|Non exposed|Non precarious patients
15992149|NCT02948452|Other|fMRI|fMRI: reward task, anxiety provocation
15992150|NCT02948439|Other|Aerobic exercise|Brisk walking 3-4 times per week for up to 40 minutes of activity.
15992151|NCT02948426|Biological|Autologous Monocytes + ACTIMMUNE + SYLATRON|The autologous monocytes cell product in 250ml total volume of investigational combination (monocytes + ACTIMMUNE + SYLATRON) is infused via the intraperitoneal catheter over 30-60 min +/- 10 min every 28 days +/- 7 days until disease progression, limiting toxicity, intercurrent medical issues, or patient withdrawal. Dosing is based on a dose escalation design including an expansion cohort at the maximum tolerated dose (MTD).
15992152|NCT02948400|Behavioral|pedestrian safety training in pedestrian virtual environment|pedestrian safety training
15992153|NCT02948361|Other|QT Ultrasound Breast Scan|Subjects will be scanned on the QT Ultrasound Breast Scanner. For subjects that may have breast calcifications and/or mass(es) and/or other finding(s) on the QT scan image(s), standard imaging modalities (e.g., mammogram and HHUS) will be performed per American College of Radiology (ACR) recommendations.
15992154|NCT02948348|Drug|Nivolumab|Capecitabine:Dose of 1650mg/m2,14days, Radiation:45Gy/25 fractions, Nivolumab :240mg on day1 of each cycle, Surgical therapy:The resection (LAR), intersphincteric resection (ISR), or abdominoperineal resection (APR).
15992155|NCT02948348|Drug|Ipilimumab|For only Cohort D,1 mg/kg at six-week intervals
15992156|NCT02948322|Device|CMRI|Myocardial Imaging (CMRI) will be performed in patients (at baseline and 6 month after treatment) and healthy volunteers (baseline)
15992157|NCT02948322|Drug|Gadolinium|gadolinium injection will be performed during CMRI in patients and healthy volunteers.
15992161|NCT02948283|Other|Laboratory Biomarker Analysis|Correlative studies
15992163|NCT02948283|Other|Pharmacological Study|Correlative studies
15992164|NCT02948283|Drug|Ritonavir|Given PO
15992165|NCT02948283|Other|Quality-of-Life|Ancillary studies
15992166|NCT02948283|Other|Questionnaire|Ancillary studies
15992167|NCT02948257|Device|Cardiva Medical VASCADE VCS|At the end of peripheral endovascular interventional procedures performed via an antegrade femoral arterial approach, the femoral arterial access site is closed with the VASCADE VCS to achieve arterial hemostasis.
15992168|NCT02948244|Dietary Supplement|Creatine Monohydrate|Synthetically produced dietary supplement Creatine Monohydrate will be used in powder form reconstituted to a drink. The dosage will be 100mg/kg/day up to a maximum of 10 grams daily.
15992169|NCT02948244|Dietary Supplement|Placebo|Placebo
15992170|NCT02948231|Device|Mistral implantation|Mistral Implant is implanted in the Mitral valve
15992171|NCT02948218|Device|Acupuncture treatment|Acupuncture treatment will be the Traditional Chinese Medicine type. Acupuncture 3 times per week, 4 weeks is one treatment period. Every patient will be given 3 treatment period.
15992172|NCT02948205|Procedure|3D group|infertility patient get TU-LESS by 3D Laparoscopy
15992173|NCT02948205|Procedure|normal group|infertility patient get normal laparoscopic surgery
15992174|NCT02948192|Other|Survey, Sample collection|Survey is collected on the dietary intake of both cohorts. Sample collection is done from patients in both cohorts at multiple time points.
15992175|NCT02948179|Procedure|Preimplantation Genetic Diagnosis|Using Preimplantation genetic diagnosis, including multiple annealing and looping-based amplification cycles amplification technique, the investigators have had screened out healthy embryos by In Vitro Fertilization. Then the investigators transplanted embryos returned to the parent. Finally, participants will have healthy baby without pathogenic gene inheritance.
15992176|NCT02948166|Procedure|Angioplasty with stenting of the femoral artery|A standard endovascular exposure is carried out under local anesthesia and a lesioned arterial segment is visualized. Stenosis or artery occlusion is passed by the hydrophilic guide. During the occlusion transluminal or subintimal artery recanalization (most frequently mixed) is conduced. Then balloon angioplasty of stenosis or occlusion are carried out. After the angiographic control if necessary stent (balloon expandable or self-expanding) of all the extension is mounted.
15992177|NCT02948166|Procedure|Open surgery|Performed open endarterectomy of the common, deep, initial of superficial femoral artery. Proximal plaque exfoliate as far as possible in the superficial femoral artery. After that, the translational and rotational motions loops under fluoroscopic guidance, continuing detachment of plaque in the antegrade direction to the distal end of plaque. Plastic of arteriotomy wounds performed patches of ksenoperikard treated with epoxy compounds. Control patency of the arterial vessel is performed intraoperatively by X-ray angiography. When rendering residual stenosis or intimal dissection, limiting blood flow, complemented by endovascular intervention plasticity.
15992178|NCT02948153|Other|clinical study|It is a comprehensive study in a large sample using multiple techniques to assess various aspects of the disease. All patients underwent the following : Induced Sputum, spirometry, fractional exhaled nitric oxide (FeNO), prick test, total IgE and blood albumin. Analysis of mucins and TLRs
15992179|NCT02948140|Procedure|MRI|
15992180|NCT02948140|Procedure|Abdominal scanner|
15992181|NCT02948127|Biological|RSV LID cp ΔM2-2 Vaccine|10^5 plaque-forming units (PFUs); administered as nose drops
15992182|NCT02948127|Biological|Placebo|Administered as nose drops
15992183|NCT02948114|Other|Control: Cow milk-based infant formula|
15992184|NCT02948114|Other|Experimental 1: Cow milk-based infant formula|Experimental 1: Cow milk-based infant formula with prebiotics
15992185|NCT02948114|Other|Experimental 2: Cow milk-based infant formula|Experimental 2: Cow milk-based infant formula with probiotics
15992186|NCT02948114|Other|Experimental 3: Cow milk-based infant formula|Experimental 3: Cow milk-based infant formula with prebiotics and probiotics
15992187|NCT02948101|Biological|Anti-CSF1 Monoclonal Antibody PD-0360324|Given IV
15992188|NCT02948101|Drug|Cyclophosphamide|Given PO
15992189|NCT02948101|Other|Laboratory Biomarker Analysis|Correlative studies
15992190|NCT02948075|Drug|Quisinostat|
15992191|NCT02948075|Drug|Paclitaxel|
15992192|NCT02948075|Drug|Carboplatin|
15992193|NCT02948036|Other|Mobile-device, plasticity-based adaptive cognitive treatment|This study employs a mobile-device delivered treatment program. Participants will be asked to use the assigned treatment program for approximately 30 minutes per session, up to seven sessions per week, over 6 weeks (42 total sessions).
15992194|NCT02948023|Biological|Ex-vivo cultivated limbal stem cell pool|0.5 million stromal and epithelial cells will be incorporated in 0.05ml of commercially available fibrin glue and pasted over the corneal lesion after epithelial debridement.
15992195|NCT02948010|Device|Auto CPAP + comfort feature A|Auto CPAP + comfort feature A using Fisher & Paykel Healthcare CPAP Device
15992196|NCT02948010|Device|Auto CPAP with comfort feature B|Auto CPAP with comfort feature B using Fisher & Paykel Healthcare CPAP Device
15992197|NCT02948010|Device|Auto CPAP with no comfort feature|Auto CPAP with no comfort feature using Fisher & Paykel Healthcare CPAP Device
15992198|NCT02948010|Device|Auto CPAP with comfort feature A+B|Auto CPAP with comfort feature A+B using Fisher & Paykel Healthcare CPAP Device
15992199|NCT02948010|Device|CPAP with comfort feature A|CPAP with comfort feature A using Fisher & Paykel Healthcare CPAP Device
15992200|NCT02948010|Device|CPAP with comfort feature B|CPAP with comfort feature B using Fisher & Paykel Healthcare CPAP Device
15992201|NCT02948010|Device|CPAP with no comfort feature|CPAP with no comfort feature using Fisher & Paykel Healthcare CPAP Device
15992202|NCT02948010|Device|CPAP with comfort feature A + B|CPAP with comfort feature A + B using Fisher & Paykel Healthcare CPAP Device
15992203|NCT02948010|Device|CPAP at Sub therapeutic level|CPAP at Sub therapeutic level using Fisher & Paykel Healthcare CPAP Device
15992204|NCT02947997|Device|OFDI capsule|Imaging of esophagus using OFDI capsule and system
15992205|NCT02947984|Radiation|Standard Treatment|55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT.
15992206|NCT02947984|Radiation|Higher Dose|55.8 CGE in 31 treatments of 1.8 CGE given once a day, for five days each week. Treatment based upon a treatment planning CT.
15992528|NCT02945527|Drug|Dexamethasone|As described above
15992207|NCT02947971|Device|Experimental OFDI Imaging|Imaging of the esophagus with a compact OFDI system and distal scanning catheter
15992208|NCT02947958|Other|Teleconsultation|Teleconsultation - the teleconsultation usage in chronic diseases, such as benign hyperplasia, seems to be a promising scenario. Once the patient symptoms are evaluated and diagnosed as a stable disease he is able to keep his treatment annually. In a way to do not overload de tertiary system, such monitoring could be done under a teleconsultation with a urological supervision in the primary care.
15992209|NCT02947958|Other|Hospital (control)|The patient will keep his usual care at the tertiary care.
15992210|NCT02947945|Drug|Reslizumab|All subjects will receive Reslizumab
15992211|NCT02947932|Drug|Resveratrol|pre-ERCP intervention
15992212|NCT02947932|Drug|Indomethacin|post-ERCP intervention in high risk patients
15992213|NCT02947919|Behavioral|Music|A previously defined list of songs will be administered by headphones to these patients with an MP3 device with headphones.
15992214|NCT02947906|Other|No intervention|No intervention
15992215|NCT02947893|Drug|Placebo Capsule(s) Once a Day by Mouth|1 capsule of Placebo once a day for 6 months followed by 2 capsules of Placebo for another 6 months
15992216|NCT02947893|Drug|Nilotinib Capsule(s) Once a Day by Mouth|1 capsule of Nilotinib 150 mg once a day for 6 months followed by 2 capsules of Nilotinib (150 mg each capsule = 300 mb total) for the subsequent 6 months
15992217|NCT02947880|Drug|Bumetanide|For the patient of 25kg and more the bumetanide is used at the posology of 1mg in the morning and 1mg in the evening, for patient under 25kg the posology is 0.5mg in the morning and 0.5mg in the evening.
15992218|NCT02947880|Drug|Placebo|For the patient of 25kg and more the placebo is used at the posology of 1mg in the morning and 1mg in the evening, for patient under 25kg the posology is 0.5mg in the morning and 0.5mg in the evening.
15992219|NCT02947867|Drug|aganirsen|aganirsen antisense oligonucleotide against Insulin Receptor Substrate (IRS-1)
15992220|NCT02947854|Drug|Fimaporfin (Photosensitizer)|
15992221|NCT02947854|Biological|Hiltonol (Poly-ICLC)|
15992222|NCT02947854|Biological|HPV E7 (Human Papilloma Virus E7) peptides|
15992223|NCT02947854|Biological|KLH (Keyhole Limpet Hemocyanin)|
15992224|NCT02947841|Other|Alternating stimulation|Two different, but equally efficacious, settings will be determined for each subject. The settings will differ by a minimum of two of the following parameters: electrode configuration, voltage, frequency and pulse width. The different settings will be named Setting A and Setting B. The treatment cohort will receive both Setting A and Setting B that will differ by the parameters listed above.
15992225|NCT02947841|Other|Placebo|The control cohort will receive Setting A but Setting B will be identical to Setting A.
15992226|NCT02947815|Drug|Clostridium Botulinum Toxin Type A|
15992227|NCT02947815|Drug|Clostridium Botulinum Toxin Type A|
15992228|NCT02947802|Other|Effectiveness of Labels in Reducing Purchasing of Sugar Sweetened Beverages|In one of our parallel assigned conditions participants will receive additional information (e.g., an intervention) of effectiveness information. These consumers will learn how effective these labels were in reducing the purchasing of sugar sweetened beverages in a recent study.
15992229|NCT02947802|Other|Control condition|In one of our parallel assigned conditions participants will receive no additional information and be asked to rate their support for the label.
15992230|NCT02947789|Procedure|Emergency surgery|Patients undergoing emergency surgery
15992231|NCT02947776|Behavioral|PEER|The experimental group will receive usual care + peer befriending. Peer befriending aims to utilise the skills and 'lived experience' of people with longer-term aphasia to offer support to others with aphasia, starting at a time of transition (discharge from hospital and withdrawal of intensive therapeutic input) and increased need. It aims to help people develop their own strategies for adjusting to life post-stroke. Peer-befrienders will visit participants 6 times over a period of 3 months (+2 times within the next 6 months). The schedule, nature of visits, and goals (e.g. discuss concerns; pursue activities) will be agreed between the pair. Visits may include: conversation, problem solving, trips out, joint activities.
15992232|NCT02947776|Behavioral|USUAL|The control group will receive usual care, i.e. all health, social care and voluntary services available to them in their borough. It is not known what exactly usual care comprises for people with aphasia who are discharged in the community with low levels of psychological problems, and this project will help to document this.
15992233|NCT02947763|Drug|mixture of metronidazole, ciprofloxacin, and minocycline|placement of intracanal medication
15992234|NCT02947750|Drug|6R-BH4|Participants will receive 200 mg of 6R-BH4 twice daily for 12 weeks. Study pills are dissolved in water or apple juice, and taken with food.
15992235|NCT02947750|Other|6R-BH4 placebo|Participants will receive a placebo that is identical to 200 mg of 6R-BH4. The placebo will be taken twice daily for 12 weeks. Study pills are dissolved in water or apple juice, and taken with food.
15992236|NCT02947750|Dietary Supplement|Folic acid|Participants will take 1 mg of folic acid daily for 12 weeks. Folic acid is given because it enhances the binding affinity of BH4 to nitric oxide synthase (NOS), and also enhances the regeneration of BH4 from inactive BH2
15992237|NCT02947750|Other|Exercise training|Participants will exercise 3 times a week on a stationary ergometer. Exercise intensity will begin at low levels (50% of maximal heart rate reserve) calculated utilizing the Karvonen method. Briefly, target exercise heart rate (HR) is calculated by subtracting the persons age from 220. Resting heart rate is then subtracted from this number. The answer is then multiplied by the target percent (50% for example) and the product is added back to resting heart rate to provide the target exercise session heart rate. Intensity will be increased by 5% every week (as tolerated by the participant) to a maximum of 80% of maximal heart rate. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week.
15992238|NCT02947750|Other|Stretching|Participants randomized to 'No Exercise Training' group will instead of aerobic exercise, undergo progressive whole body stretching and toning exercises designed for individuals 65 and older. This type of low intensity activity is designed not to increase heart rate and will serve as the Control group to the Exercise Training group. The Control group will come in for stretching sessions 3 times per week for 20-45 minutes.
15992272|NCT02947516|Procedure|Percutaneous liver biopsy|Participants will undergo percutaneous liver biopsy per standard protocol.
15992451|NCT02946125|Drug|MDD-administered EYN-1601|Phenylephrine hydrochloride ophthalmic solution 10% formulated for microdose spray delivery
15992239|NCT02947750|Dietary Supplement|Histidine and beta-alanine supplementation|Histidine and beta-alanine are two over-the-counter supplements commonly used to enhance sports performance in athletes. Participants randomized to this study arm will receive combined histidine (4g/day) and beta-alanine (3.2g/day) supplementation.
15992240|NCT02947750|Other|Histidine and beta-alanine placebo|Participants randomized to this study arm will receive a placebo to match combined histidine (4g/day) and beta-alanine (3.2g/day) supplementation.
15992241|NCT02947737|Other|Amniotic membrane dressing|We will place an amniotic membrane dressing on the donor site
15992242|NCT02947737|Other|Gentamicin and xeroform dressing|We will place xeroform, gentamicin and telfa on the donor site
15992243|NCT02947724|Drug|SURGICEL®|Insertion of 4 pieces of SURGICEL® inside the cyst cavity. Insertion of 4 pieces of SURGICEL® inside the remaining ovarian tissues.
15992244|NCT02947711|Drug|E2027|2 x 50 mg capsules, once daily on Day 1 and Day 12
15992245|NCT02947711|Drug|Diltiazem ER|1 x 300 mg capsule, once daily on Days 7 through 24
15992246|NCT02947685|Drug|palbociclib|o Starting dose: 125 mg capsule taken orally once per day for 21 days followed by 7 days off to complete 28 day cycle. Dose reductions: 100 mg, 75 mg. allowed. Number of Cycles: until progression or unacceptable toxicity develops
15992247|NCT02947685|Drug|trastuzumab|Patients must have received a minimum of 4 and maximum of 8 cycles of induction therapy prior to randomization to Arm A or B, at which point they will continue on antiHER2 therapy and endocrine therapy, with or without palbociclib. Trastuzumab dosing will be determined based on a loading dose of 8mg trastuzumab/kg body weight for Q3WK dosing schedules or a maintenance dose of 6mg/kg trastuzumab/kg dosing weight for Q3WK dosing schedules. Loading dose will be administered on Cycle 1, Day 1.
15992248|NCT02947685|Drug|pertuzumab|Patients must have received a minimum of 4 and maximum of 8 cycles of induction therapy prior to randomization to Arm A or B, at which point they will continue on antiHER2 therapy and endocrine therapy, with or without palbociclib.Pertuzumab will be administered at a loading dose of 840 mg infusion and then at a maintenance dose of 420 mg q3wks. If patient is within 5 weeks of receiving loading dose at Cycle 1, Day 1, patient may start with maintenance dose of 420 mg.
15992249|NCT02947685|Drug|letrozole|There are several allowed endocrine treatment agents for Arm A and Arm B of this study. Administration is performed on an outpatient, self-administration basis according to local requirements and local standard practice. Endocrine treatment may have started before the patient enters the study. Agents will be administered at the discretion of principal investigator as well as according to standard institutional or regional practice. Recommended dosing regimen for letrozole oral therapy is 2.5 mg orally, once a day.
15992250|NCT02947685|Drug|Anastrozole|There are several allowed endocrine treatment agents for Arm A and Arm B of this study. Administration is performed on an outpatient, self-administration basis according to local requirements and local standard practice. Endocrine treatment may have started before the patient enters the study. Agents will be administered at the discretion of principal investigator as well as according to standard institutional or regional practice. Recommended dosing regimen for anastrozole is 1 mg orally, once a day.
15992251|NCT02947685|Drug|Exemestane|There are several allowed endocrine treatment agents for Arm A and Arm B of this study. Administration is performed on an outpatient, self-administration basis according to local requirements and local standard practice. Endocrine treatment may have started before the patient enters the study. Agents will be administered at the discretion of principal investigator as well as according to standard institutional or regional practice. Recommended dosing regimen for exemestane is 25 mg orally, once a day.
15992252|NCT02947685|Drug|Fulvestrant|There are several allowed endocrine treatment agents for Arm A and Arm B of this study. Administration is performed on an outpatient, self-administration basis according to local requirements and local standard practice. Endocrine treatment may have started before the patient enters the study. Agents will be administered at the discretion of principal investigator as well as according to standard institutional or regional practice. Recommended dosing regimen for Fulvestrant is 250 mg injections on Day 1 and Day 15 of Cycle 1, and q4weeks thereafter.
15992253|NCT02947672|Drug|Intravenous Dexamethasone|
15992254|NCT02947672|Drug|Intraperitoneal Dexamesathone|
15992255|NCT02947646|Device|BabyGentleStick™ ON|
15992256|NCT02947646|Device|BabyGentleStick™ OFF|
15992257|NCT02947633|Drug|Single-injection sciatic PNB|Single-injection sciatic PNB is a regional anesthetic technique employed to anesthetize the sciatic nerve with a single dose of local anesthetic. This technique offers pain control for a limited amount of time based on the volume and concentration of local anesthetic used.
15992258|NCT02947633|Drug|Continuous sciatic PNB|"Continuous sciatic PNB entails placing a continuous perineural infusion (CPI) catheter so that local anesthetic may be released slowly but continuously adjacent to the sciatic nerve (perineural) for several days postoperatively. The continuous PNB has the ability to reliably provide analgesia on subsequent postoperative days.
~Participants my be randomized to receive an additional experimental continuous pain ball during surgery which can provide up to 48 hours of pain relief."
15992259|NCT02947620|Drug|Metformin/Atorvastatin 1500mg/40mg, QD|
15992260|NCT02947620|Drug|Metformin 1500mg, QD|
15992261|NCT02947620|Drug|Atorvastatin 40mg, QD|
15992262|NCT02947607|Procedure|Colon biopsies|
15992265|NCT02947568|Other|non-interventional study|
15992266|NCT02947555|Other|Non interventional|
15992267|NCT02947542|Device|One-catheter concept|Coronary angiography will be performed using the one-catheter concept.
15992268|NCT02947542|Device|Standard catheter|Coronary angiography will be performed using a standard catheter.
15992269|NCT02947529|Drug|Tranexamic Acid|
15992270|NCT02947529|Other|Placebo|
15992271|NCT02947516|Procedure|Endoscopic ultrasound-guided liver biopsy|Participants will undergo endoscopic ultrasound per standard technique, with liver biopsy performed at that time.
15992273|NCT02947503|Drug|Metformin HCL 850 CF|At inclusion, patients (N=500) will be randomized 1:1 to metformin vs usual care (850 mg tablets, 3 times daily or, if tolerance is suboptimal, a lower maximally tolerated dose, 1-2 times daily), on top of diet and lifestyle, with an insulin rescue in both arms if needed.
15992274|NCT02947490|Other|Self BP measurement|BP home measurement by patient, results to GP and GP alters treatment as per usual practice
15992275|NCT02947490|Other|Standard Care|Self BP measurement and patient management of anti-hypertensive treatment altering their own medication under supervision depending on home BP measurements
15992276|NCT02947490|Other|Standard BP management|GP to measure BP and manage BP control
15992277|NCT02947490|Other|Treatment|Contacted by the study nurse and depending on BP levels recorded the patient will alter their medication to achieve target BP levels.
15992278|NCT02947477|Behavioral|EmoTrak|Ecological Momentary Assessment of Emotion through Iphone App
15992279|NCT02947464|Procedure|Standard clinical practice|Control weight will be started in obese children to decrease upper airway resistance and airway collapsibility. Close follow-up in order to detect comorbidities.
15992280|NCT02947464|Device|Standard clinical practice + Rapid Maxillary Expansion|Mid-palatal suture osteogenic distraction delivered through a self-activated acrylic intraoral device custom-fit into the children´s palate and maxillary posterior teeth providing a transverse expansion of the dentofacial skeleton.
15992281|NCT02947451|Other|Manual Therapy|"In manual therapy group will be assigned a protocol with manual passive stretching for the quadriceps muscles, hamstrings, triceps surae, adductors and abductors of the hip; myofascial release peripatellar; joint mobilization grades 1 and 2 for tibiofemoral joint and femoro - patellar in the affected knee.
~Stretching, myofascial release and mobilizations will be held for 30 seconds, with three repetitions of each. The intervention will be applied only once."
15992282|NCT02947451|Other|TENS|In TENS group will be applied to continuous current mode, frequency 100Hz and pulse width of 50μs for 40 minutes in a single application. The intensity will be defined by the patient, should the stimulus be considered intense, but pleasant to it.
15992283|NCT02947438|Drug|EPREX®|"Recombinant human erythropoietin falls under the pharmacological class of haematopoietic / anti anaemic agents. It has been developed for the treatment of anaemia in subjects with chronic kidney disease.
~Erythropoietin, also known as EPO, is a glycoprotein hormone that controls erythropoiesis, or RBC production. It is a cytokine (protein signalling molecule) for erythrocyte precursors in the bone marrow. Human EPO has a molecular weight of 34,000."
15992284|NCT02947438|Drug|EPIAO®|"Recombinant human erythropoietin falls under the pharmacological class of haematopoietic / anti anaemic agents. It has been developed for the treatment of anaemia in subjects with chronic kidney disease.
~Erythropoietin, also known as EPO, is a glycoprotein hormone that controls erythropoiesis, or RBC production. It is a cytokine (protein signalling molecule) for erythrocyte precursors in the bone marrow. Human EPO has a molecular weight of 34,000."
15992285|NCT02947412|Other|laparoscopic sleeve gastrectomy|laparoscopic sleeve gastrectomy
15992286|NCT02947399|Radiation|Radioactive Iodine 124|After thyroid hormone withdrawal for 3-5 weeks, a dose of radioactive iodine 124 ( I-124) 1.7 mCi is administrated orally and PET imaging is done for 5 continuous days including the day of the dose administration. On each day, just before imaging, 5 ml of blood is drawn.
15992290|NCT02947373|Drug|Hyperpolarized Pyruvate|Hyperpolarized Pyruvate
15992291|NCT02947360|Other|Focused vascular ultrasound of the carotid arteries|Emergency physicians and a trained research sonographer will perform a focused vascular ultrasound of the carotids (FOVUS) in patients presenting to the emergency department with chest pain. The diagnostic test characteristics (sensitivity, sensitivity, negative predictive value, positive predictive value and likelihood ratios) for FOVUS carotid plaque height will be determined in relation to our primary outcome (30-day major adverse cardiac events)
15992292|NCT02947347|Drug|ibrutinib|ibrutinib 560mg administered orally
15992293|NCT02947347|Drug|placebo to match ibrutinib|placebo capsules to match ibrutinib administered orally
15992294|NCT02947347|Drug|rituximab|rituximab 375mg/m^2 IV
15992295|NCT02947347|Drug|ibrutinib|ibrutinib 560mg administered orally
15992296|NCT02947347|Drug|placebo to match ibrutinib|placebo capsules to match ibrutinib administered orally
15992297|NCT02947334|Biological|Bococizumab|Bococizumab PFS
15992298|NCT02947334|Drug|Placebo|Placebo
15992299|NCT02947321|Procedure|Genicular Nerve RFA|Under fluoroscopic guidance, the target locations based on boney landmarks of the superior lateral (SL), superior medial (SM), and inferior medial (IL) branches of the genicular nerve will be determined. RFA probes will be placed and connected to the RFA generator and the generator is activated. The RFA is performed.
15992300|NCT02947321|Procedure|Sham Genicular Nerve RFA|Under fluoroscopic guidance, the target locations based on boney landmarks of the superior lateral (SL), superior medial (SM), and inferior medial (IL) branches of the genicular nerve will be determined. The RFA probes for the control group will not be connected to the RFA generator (no neurotomy); however, the generator will still be activated to mimic the RFA group.
15992301|NCT02947282|Other|Educational Workshop|They will attend a 2 hour class on pelvic floor health
15992302|NCT02947269|Drug|Prucalopride|Prucalopride 2mg capsule
15992303|NCT02947269|Drug|Placebo Oral Capsule|Placebo capsule
15992304|NCT02947256|Procedure|standard laparoscopic cholecystectomy|which included the classic dissection of Calot's triangle to achieve the CVS, with separate clipping and division of cystic duct and artery
15992305|NCT02947256|Procedure|RI approach|which included separation of the lower third of GB from its bed down to its pedicle (artery and duct) with mass ligation of both.
15992416|NCT02946437|Drug|Midazolam|Before and after postconditioning with sevoflurane the patients will be sedated with intravenous sedatives (midazolam or propofol). The quality of sedation before the postconditioning (propofol or midazolam) will be compared to the sedation one hour after starting the postconditioning (sevoflurane) in the same patient.
15992417|NCT02946437|Device|MIRUS™System|The MIRUS™System is the normally used standard equipment for the administration of volatile anaesthetics to patients.
15992418|NCT02946424|Drug|Placebo Oral Capsule|12 month course of daily placebo
15992419|NCT02946424|Drug|Simvastatin|12 month course of daily simvastatin
15992306|NCT02947243|Device|VR distraction via Oculus Rift|In addition to standard pharmacological treatment, Virtual reality distraction through the use of Oculus Rift® will be used as the experimental intervention. The Oculus Rift (Consumer version) is made of two Oled panels with a resolution of 1200p running at 90Hz. It has very effective 360 degree positional tracking and integrated 3D audio. These combine to produce a high level of immersion, with high photorealism while maintaining the low latency necessary to induce presence and prevent cybersickness. The child, depending on the burn site, will have the opportunity to interact with the game. Video games, approved by healthcare professionals with extensive experience in pediatrics, will be adapted for children and tailored to minimize cyber sickness.
15992307|NCT02947243|Drug|Morphine|As per unit's protocol
15992308|NCT02947230|Other|Tailored Knowledge Translation|Tailored knowledge translation strategies specific to maintaining and increasing physical mobility with age.
15992309|NCT02947217|Biological|Influenza Vaccine|Inactivated influenza vaccine indicated for immunization against disease caused by influenza virus subtype A and type B present in the vaccine. Approved for use in persons 5 years of age and older. Single Dose prefilled 0.5 ml syringe.
15992310|NCT02947217|Other|Sterile Saline|0.5 mL of sterile Saline administered im
15992311|NCT02947204|Other|Intermittent oxygen monitoring|Oxygen saturation and vital signs will be measured intermittently at a frequency of every 4 hours by the bedside nurse through the child's hospital stay until discharge. Vital signs will be completed every 4 hours.
15992312|NCT02947204|Other|Continuous oxygen monitoring|Oxygen saturation will be measured continuously through the child's hospital stay until discharge. Vital signs will be completed every 4 hours.
15992313|NCT02947191|Biological|Collagen membrane + HUC-MSCs|After separating bilateral nasal septum mucosas via septum reconstruction incision under endoscopy, the clinical grade HUC-MSCs combined with collagen membrane will be transplanted between the bilateral nasal septum mucosas and fixed. The patients will be treated with antibiotics for 1 week, and with naristillae menthae compositae, mucus promoting agent and other drugs for improving microcirculation for 1 month.
15992314|NCT02947178|Procedure|Fascial iliac regional soft tissue infiltration blockade|Fascial iliac regional soft tissue infiltration blockade: Pain relief procedure (offered to all patients undergoing hip arthroscopy)
15992315|NCT02947178|Behavioral|Pain Score Survey|Utilizing: Defense and Veterans Pain Rating Scale (DVPRS)
15992316|NCT02947178|Behavioral|Pill Count|Patient reported as needed (prn) pain medication usage
15992317|NCT02947178|Drug|Bupivacaine|
15992318|NCT02947178|Drug|Liposomal Bupivacaine|
15992319|NCT02947165|Drug|NIS793|Anti-TGF beta antibody tested on a Q3W regimen or alternative Q2W regimen.
15992320|NCT02947165|Drug|PDR001|Anti-PD-1 antibody tested on a Q3W regimen or alternative Q4W regimen.
15992321|NCT02947152|Drug|HKT288|Cadherin-6-targeting antibody-drug conjugate for intravenous administration
15992322|NCT02947139|Drug|Co-administration of DWC20155/DWC20156|
15992323|NCT02947139|Drug|DWC20161|
15992324|NCT02947126|Drug|Hypertonic Saline|Inhaled 7% Hypertonic saline
15992325|NCT02947126|Drug|Isotonic Saline|Inhaled 0.9% Isotonic saline
15992326|NCT02947126|Drug|Indium-DTPA|Inhaled Indium 111 DTPA
15992327|NCT02947126|Drug|Technetium Sulfur Colloid|Inhaled Technetium99m sulfur colloid
15992328|NCT02947113|Drug|Cisplatin|Cisplatin will be administrated in a 3-weekly scheme for 2 courses combined with pemetrexed (non-squamous cell lung cancer) or etoposide (squamous cell lung cancer)
15992329|NCT02947113|Radiation|hypofractionated radiotherapy|Hypofractionated radiotherapy of 24 x 2.75 Gy will be given combined with a 3-weekly scheme of cisplatin and pemetrexed/etoposide
15992330|NCT02947113|Drug|Pemetrexed|Pemetrexed will be administrated in a combination with cisplatin and hypofractionated radiotherapy (for non-squamous cell lung cancer)
15992331|NCT02947113|Drug|Etoposide|etoposide will be administrated in a combination with cisplatin and hypofractionated radiotherapy (for squamous cell lung cancer)
15992332|NCT02947100|Drug|SCD-Omegatex™|"Subjects will receive SCD-Omegatex™ (Enteric Fish Oil 250 DHA/27 EPA Soft Gelatin Capsule, 450 mg) at one of two daily doses, orally, once a day for 6 months. The trial will follow a 3+3 design using two dose levels. In the phase I portion, subjects will be treated with a dose of 25 mg/kg/day DHA and EPA. If this is tolerated without dose limiting toxicity (DLT), a subsequent cohort of patients will be treated at a dose of 37.5 mg/kg/day with a maximum total daily dose of 4 grams. Once a maximum tolerated dose (MTD) is determined, subjects on the phase II portion of the study will be treated at that dose."
15992333|NCT02947087|Drug|Prolastin-C|Patients will receive Prolastin-C at 60mg/kg on day 0, 7, 14, and 21 days of transplantation
15992334|NCT02947087|Drug|Placebo|Patients will receive saline on day 0, 7, 14, and 21 days of transplantation
15992335|NCT02947074|Behavioral|Yoga Meditation|Briefly, subjects will be taught to progressively drive their attention to their inner-self, and keep a calm, nonjudgmental and observational approach towards their own thoughts for 30 minutes.
15992336|NCT02947061|Drug|S1 plus Docetaxel|S1 80mg to 120 mg per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1
15992337|NCT02947061|Drug|Capecitabine plus Docetaxel|Capecitabine 1,000 mg/m2 per day on Days 1-14, every 21 days; Docetaxel 75mg/m2 on Day 1
15992338|NCT02947048|Drug|L1-79|
15992339|NCT02947048|Drug|Placebo|
15992340|NCT02947035|Procedure|Thyroid lobectomy|Thyroid lobectomy is removal of only part of the thyroid
15992341|NCT02947035|Procedure|Total thyroidectomy with CCND|Total thyroidectomy with central compartment lymph node dissection is removal of the entire thyroid with the surrounding lymph nodes
15992342|NCT02947022|Drug|Calcium DTPA|"On Day 1, 2.5 mL of Ca-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Ca-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening.
~The same treatment therapy will consist of 3 time-points, approximately 1 month apart."
15992420|NCT02946411|Procedure|Cardiac surgery|Glucose level will be measured after cardiac surgery.
15992343|NCT02947022|Drug|Zinc DTPA|"On Day 2, 2.5 mL of Zn-DTPA (1 g/5 mL) will be administered over a period of 1 minute. A solution of normal saline will then be administered at a rate of 300 mL/hr over 30 minutes. Patients will be seated with hands lowered to their sides to allow the chelator to dwell slightly in the soft tissues of the hands and feet. Patients will then be moved to a supine position and the infusion rate increased to 750 mL/hr over the next 60 minutes. At 90 minutes the remaining 2.5 mL of Zn-DTPA will administered IV over a period of 1 minute, and the normal saline will continue for the remaining 9 minutes. The IV line will then be removed. Patients will be instructed to drink plenty of fluids that evening.
~The same treatment therapy will consist of 3 time-points, approximately 1 month apart."
15992344|NCT02947009|Behavioral|Diagnostic Study|Participants will undergo laryngoscopy at baseline and with exercise challenge and will rate severity of various symptoms related to the larynx (ex. shortness of breath, voice changes, cough).
15992345|NCT02946996|Drug|Metformin|
15992346|NCT02946996|Other|OPC|OPC is a derivative of grape seed extract
15992347|NCT02946983|Other|Fructose|Intragastric administration of fructose (25g dissolved in 250ml distilled water)
15992348|NCT02946983|Other|Control|Intragastric administration of distilled water
15992349|NCT02946970|Other|Quinine hydrochloride|Intragastric administration of a bitter tastant agonist (10 μmol/kg quinine-hydrochloride)
15992350|NCT02946970|Other|Control|Intragastric administration of distilled water
15992351|NCT02946957|Behavioral|Cognitive Behavior Therapy for Insomnia|Six telephone sessions that last 20-30 minutes presenting cognitive behavioral therapy for insomnia.
15992352|NCT02946957|Behavioral|Education Only Control|Six telephone sessions that last 20-30 minutes presenting sleep and osteoarthritis education.
15992353|NCT02946944|Drug|Sildenafil/apixaban|After arrival to the emergency department, a series of surveys to determine the risk of death from pulmonary embolism are carried out. Then angiography, tensiometry of SBCC, catheter thrombus fragmentation are scheduled. Then puncture of the right jugular vein is performed. PigTail catheter is inserted via guidewire into the pulmonary artery . Angiography of the pulmonary arteries is performed. Miller index is calculated. Catheter thrombus fragmentation is performed by a PigTail catheter. RV, RA pressures are measured. In the ICU heparin is prescribed (of 1000 units per hour) under the control of PTT (50-75s). The next day patients are randomizaed to assign them into 2 groups. Dual drug therapy is going to be administered to this group (experimental): sildenafil 30mg 3p \ g + 10 mg apixaban 2p \ d for 14 days. On the 7th day MSCT angiography of the pulmonary aretry with contrast and echocardiogram are performed. On the 14th day the controlechocardiogram is performed .
15992354|NCT02946944|Drug|apixaban|After arrival to the emergency department, a series of surveys to determine the risk of death from pulmonary embolism are carried out. Then angiography, tensiometry of SBCC, catheter thrombus fragmentation are scheduled. Then puncture of the right jugular vein is performed. PigTail catheter is inserted via guidewire into the pulmonary artery . Angiography of the pulmonary arteries is performed. Miller index is calculated. Catheter thrombus fragmentation is performed by a PigTail catheter. RV, RA pressures are measured. In the ICU heparin is prescribed (of 1000 units per hour) under the control of PTT (50-75s). The next day patients are randomizaed to assign them into 2 groups.Mono drug therapy is going to be administered to this group (active comparator): apixaban 10 mg 2p \ d for 14 days. On the 7th day MSCT angiography of the pulmonary aretry with contrast and echocardiogram are performed. On the 14th day the controlechocardiogram is performed .
15992355|NCT02946931|Drug|Prizbind|Idarucizumab
15992356|NCT02946918|Drug|Levothyroxine|Patients post-thyroidectomy will receive either levothyroxine in tablet form or in gelcaps. Initial dose 1.5-1.8 mcg per kg, orally and daily
15992357|NCT02946892|Drug|Carvedilol|Carvedilol will be given for 12 weeks and then an exercise test will be performed
15992358|NCT02946892|Drug|Placebo|Placebo will be given for 12 weeks and then an exercise test will be performed
15992359|NCT02946879|Biological|AAV OPTIRPE65|comparison of different doses of AAV RPE65
15992360|NCT02946853|Procedure|Atrioventricular junctional (AVJ) ablation|RF energy delivery to AV node to create complete AV block
15992361|NCT02946853|Device|Cardiac resynchronization therapy - defibrillator|Insertion of device capable of providing biventricular pacing and cardiac defibrillation
15992362|NCT02946840|Device|FNA with 25 G Beacon needle|
15992363|NCT02946827|Dietary Supplement|Balanced low FODMAPs /gluten free diet|
15992364|NCT02946827|Dietary Supplement|Balanced gluten free diet|
15992365|NCT02946814|Drug|essential oils|
15992366|NCT02946814|Drug|essential oils without mouthwash|
15992367|NCT02946814|Drug|sterile water|
15992368|NCT02946801|Drug|Essential oils|
15992369|NCT02946801|Drug|Essential oils without alcohol|
15992370|NCT02946801|Drug|Sterile water|
15992371|NCT02946788|Drug|Minocycline|BPX-01 1 or 2% topical gel will be applied to face once daily
15992372|NCT02946762|Other|Test and treat|All incarcerated individuals found to have HIV infection will be offered universal voluntary HIV counseling and testing (HCV) through routine care provided at the correctional facility followed by referral to the study for immediate (routine, non-study prescribed) ART, regardless of CD4 cell count. The ART regimen prescribed will be the standard first-line, fixed-dose combination efavirenz plus lamivudine/emtricitabine and tenofovir per Zambian national guidelines.
15992373|NCT02946736|Behavioral|FSSB/Sleep Leadership Training|Supervisors will receive a training addressing family-supportive supervisor behaviors and sleep leadership.
15992374|NCT02946736|Behavioral|Actigraphy Feedback|Supervisors and employees will receive personalized feedback on their sleep and activity measurements.
15992375|NCT02946723|Procedure|ultrasound|Lead implantation surgery for SNM using ultrasound guided technique
15992376|NCT02946723|Procedure|X-ray|Lead implantation surgery for SNM using X-ray technique
15992377|NCT02946710|Biological|cerebrospinal fluid|Biological analysis on cerebrospinal fluid
15992421|NCT02946385|Biological|Meningococcal ABCWY Vaccine|Intramuscular injection of one booster dose at Day 1 to follow-on subjects in the ABCWY_ 0_2 Group, ABCWY_ 0_2_6 Group and ABCWY_ 0_6 Group, primed with 2 or 3 doses of the study vaccine and 2 doses at Days 1 and 61 to naïve subjects in the ABCWY naïve group.
15992452|NCT02946125|Drug|Phenylephrine 2.5% Eyedrop|Phenylephrine hydrochloride ophthalmic solution 2.5% eyedrop
15992453|NCT02946125|Drug|Phenylephrine 10% Eyedrop|Phenylephrine hydrochloride ophthalmic solution 10% eyedrop
16006497|NCT02839226|Drug|Placebo|
15992378|NCT02946697|Behavioral|Social support intervention|The social support intervention is a 7-week program includes educational and peer mentoring support components. The education curriculum provides information on recognizing side effects of treatment and differentiating them from symptoms of cancer recurrence, physical therapy and alternative treatment, stress management, recognizing depression and managing emotional problems, communication with family members, and body image. The peer-support component assigns each participant with a mentor who is a breast cancer survivor. They share their own experience with participants and also make weekly phone calls to mentees during the intervention to provide support and address remaining concerns.
15992379|NCT02946684|Drug|Letrozole|Adjuvant therapy to recFSH during ovarian stimulation
15992380|NCT02946684|Drug|Placebo|Adjuvant therapy to recFSH during ovarian stimulation
15992381|NCT02946671|Biological|Mogamulizumab|Mogamulizumab (0.1, 0.3 or 1.0 mg/kg) is administered.
15992382|NCT02946671|Biological|Nivolumab|Nivolumab (3.0 mg/kg) is administered.
15992383|NCT02946658|Procedure|lipoaspiration|Closed syringe harvesting subdermal fat
15992384|NCT02946658|Procedure|ADcSVF|Isolation of AD-cSVF
15992385|NCT02946658|Procedure|Normal Saline IV|Normal Saline IV containing AD-cSVF
15992386|NCT02946645|Device|Neuromuscular Bite (orthotic/sub-lingual)|Bite is a device which simulates a set of properly positioned teeth
15992387|NCT02946645|Procedure|Mandibular Physiotherapy|"Mandibular Stabilisation Exercises
~Place knuckle of index finger between top and bottom teeth.
~Remove it, keeping the teeth separated one-knuckle apart.
~Apply gentle pressure to the to the jaw using your index finger/thumb as demonstrated in the pictures above."
15992388|NCT02946645|Other|Placebo|No interventions.
15992389|NCT02946632|Drug|triple combination therapy|Xigduo (metformin 1000mg + dapagliflozin 10mg) saxagliptin 5mg
15992390|NCT02946632|Drug|Stepwise add-on therapy|metformin -> glimepirde -> sitagliptin
15992391|NCT02946619|Behavioral|Self-Regulation Condition|
15992392|NCT02946619|Behavioral|Enhanced self-Regulation Condition|
15992393|NCT02946606|Drug|GX-H9|Human growth hormone
15992394|NCT02946606|Drug|Genotropin|Human growth hormone
15992395|NCT02946593|Behavioral|Stroll Safe outdoor fall prevention program|The structure of the program will model the evidenced-based Lifestyle Re-Design program (Clark et al., 2012). Session 1, 2, 4 & 5 will include a brief didactic presentation about outdoor fall risks and strategy use from the group leader. This will be followed by group discussion/problem solving related to addressing risks. Identified strategies will be recorded on a wipe board and transcribed for group members in order to create handouts. Each 90 minute session will end with action planning, where participants will write down behavioral changes they will implement in the coming week. Session 3 and 6, also 90 minutes, will include outdoor mobility training and practice using strategies discussed in previous sessions. Training sessions will be led by the PI and an assistant. The final session will be a review of risks, strategy use, and reinforcement of behavioral changes in participant's action plans.
15992396|NCT02946593|Behavioral|Outdoor fall prevention brochure|The control group participants will be given a written brochure on tips for preventing outdoor falls.
15992397|NCT02946580|Drug|MOVANTIK™ (naloxegol)|
15992398|NCT02946580|Drug|Sugar Pill|
15992399|NCT02946567|Other|Noisy City information about hearing health care|Participants will play the game Noisy City, which contains information about hearing health care.
15992400|NCT02946567|Other|Generic Game|Participants will play a generic game without any particular information about hearing health care.
15992401|NCT02946554|Biological|HepaStem|
15992402|NCT02946541|Drug|evogliptin 5mg|evogliptin 5mg, QD
15992403|NCT02946541|Drug|Placebo|Placebo, QD
15992404|NCT02946528|Device|urgent-start peritoneal dialysis catheter|Patients initiated peritoneal dialysis as urgent-start dialysis modality with a peritoneal dialysis catheter.
15992405|NCT02946528|Device|central venous catheter|Patients initiated hemodialysis as urgent-start dialysis modality with a central venous catheter.
15992406|NCT02946515|Behavioral|Educational Intervention|The educational intervention will be the online simulation training program. Participants will be taught how to use the simulation during a 30 minute orientation session with a research staff person. We will use a mastery based approach rather than prescribing an absolute number of hours participants need to play. The criteria are as follows: 1) achieving a score of 90% or more on 2 out of the last 3 simulations played or 2) maximum of 8 hours of play, whichever comes first. After the orientation sessions, training sessions will be completed by participants on their own. The research team will confirm remote usage, and contact participants by email and phone to prompt usage as needed. The research team anticipates that the proposed method will accommodate for participant schedules while still ensuring intervention compliance.
15992407|NCT02946515|Behavioral|Wait List Control|Access to the online simulation training after the follow-up measurement visit is complete
15992408|NCT02946502|Procedure|Handheld dynamometry (handgrip strength)|Patients will perform handgrip strength dynamometry through holding the device in their dominant hand with the maximum strength, with standardized arm and body positions, as well as incentives
15992409|NCT02946489|Drug|CI-581a|CI-581a will be administered in wk2 and potentially in wk 3 or 4.
15992410|NCT02946476|Other|prognostic impact of non cardiac comorbidities|
15992411|NCT02946463|Biological|Ravulizumab|All treatments were given as intravenous (IV) infusions. For participants weighing ≥40 to <60 kilogram (kg): 2400 mg was given as a single loading dose, followed by 3000 mg as maintenance dose. For participants weighing ≥60 to <100 kg: 2700 mg was given as a loading dose, followed by 3300 mg as maintenance dose. For participants weighing ≥100 kg: 3000 mg was given as a loading dose, followed by 3600 mg as maintenance dose.
15992412|NCT02946463|Biological|Eculizumab|All treatments were given as IV infusions. Participants were administered induction doses of 600 mg followed by maintenance doses of 900 mg.
15992413|NCT02946450|Drug|Other: Not applicable-observational study|
15992414|NCT02946437|Drug|Sevoflurane|Postconditioning with sevoflurane (0.5-1.5vol%) for 4 hours after coiling or clipping of cerebral aneurysm in patients with severe SAH
15992415|NCT02946437|Drug|Propofol|Before and after postconditioning with sevoflurane the patients will be sedated with intravenous sedatives (midazolam or propofol). The quality of sedation before the postconditioning (propofol or midazolam) will be compared to the sedation one hour after starting the postconditioning (sevoflurane) in the same patient.
16007198|NCT02833883|Drug|Enzalutamide|
15992422|NCT02946385|Biological|Meningococcal B Recombinant vaccine|Intramuscular injection of one booster dose of the rMenB+OMV vaccine to subjects in the B_0_2 group, primed with 2 doses of the vaccine and intramuscular injection of 2 doses at Days 1 and 61 in the deltoid area of the non-dominant arm to naïve subjects in the rMenB+OMV Naïve group.
15992423|NCT02946372|Procedure|internal limiting membrane transplantation (ILMT)|internal limiting membrane autologous transplantation (ILMT)
15992424|NCT02946359|Drug|Crizotinib, bevacizumab|Eligible patients with ALK translocation or ROS1 translocation or MET amplification will be treated with Crizotinib at the standard dose of 250 mg BID and bevacizumab at the dose of 7.5mg/kg every three weeks. The dose of crizotinib and bevacizumab may be adjusted depending on the type and severity of toxicity encountered
15992425|NCT02946346|Other|vaginal sampling|
15992426|NCT02946320|Device|Predilatation with non-compliant balloon|Coronary artery stenosis is dilated before BVS implantation with the use of non-compliant balloon (standard procedure). Size and dilatation pressure is done according to OCT measurement of the coronary artery (distal segment / balloon diameter = 1:1)
15992427|NCT02946320|Device|Predilatation with scoring balloon (Scoroflex)|Coronary artery stenosis is dilated before BVS implantation with the use of scoring balloon. Size and dilatation pressure is done according to OCT measurement of the coronary artery (distal segment / balloon diameter = 1:1)
15992428|NCT02946320|Device|Predilatation with cutting balloon (Flextome)|Coronary artery stenosis is dilated before BVS implantation with the use of cutting balloon. Size and dilatation pressure is done according to OCT measurement of the coronary artery (distal segment / balloon diameter = 1:1)
15992429|NCT02946307|Device|Restore DEB（dimeter>2.00 mm）|
15992430|NCT02946307|Device|Resolute DES|
15992431|NCT02946307|Device|Restore DEB（dimeter:2.00 mm）|
15992432|NCT02946294|Drug|Bupivacaine 0.25% with epinephrine|
15992433|NCT02946294|Drug|Bupivacaine 0.25% with epinephrine|
15992434|NCT02946281|Behavioral|Do CHANGE|The intervention aims to increase behavioral flexibility and change patients' (unhealthy) lifestyle. At the same time the intervention should increase patient self-management and improve the patient reported outcomes (e.g. quality of life, anxiety, depression).
15992435|NCT02946268|Drug|Ropivacaine|Change in administration of ropivacaine. Rate, Volume and Interval of bolus altered.
15992436|NCT02946255|Behavioral|Welcome Basket (WB)|"Peer Support Workers (PSWs) hold 1-2 meetings with clients (30-60 minutes) in the 2-week period before they are discharged from hospital. They describe the program and undertake an assessment. From this assessment the two core components of the intervention are initiated. First, a welcome basket is created for the client. The PSW also forms a plan with the client about tours of their neighbourhood to familiarize them with the local resources and support them in building confidence in accessing their local communities. These activities will take place through weekly visits (2 hours/visit) in the 4 weeks immediately following discharge. WB will be provided in combination with core Cognitive Adaptation Training (CAT) compensatory interventions."
15992437|NCT02946255|Behavioral|Welcome Basket Brief (WBbr)|The brief version of the Welcome Basket (WBbr) was developed based upon the observation in feasibility testing that for some participants much of the benefit of this approach appeared to be centred upon the visits immediately prior and subsequent to discharge. In the WBbr the same core components will be present, albeit in an abbreviated form with one 30-60 minute visit in the week prior to discharge and a single, 3-hour visit in the week subsequent to discharge in which the welcome basket would be delivered, core CAT strategies discussed and implemented, and some basic orientation to community resources undertaken. This brief version of the intervention has not to date been studied.
15992438|NCT02946255|Behavioral|Treatment As Usual|Treatment as usual (TAU) involves the typical discharge procedures for clients from Unit 2, Forensic and EPU wards at CAMH. It includes referral to outpatient psychiatric services and relevant community supports with the transition facilitated by inpatient social work staff.
15992439|NCT02946242|Device|Ultrasound Exam|Subjects will be scheduled to attend up to up to five (5) ultrasound scans per day lasting up to 60 cumulative minutes each with approximately a 15 minute break before starting another study scan (limited to 15 cumulative minutes of scan time per eye, per day for ophthalmic scanning) as long as they remain eligible per the study inclusion and eligibility criteria.
15992440|NCT02946229|Device|Ultrasound scan|Collection of ultrasound data sets that include routine ultrasound data (eg, extravascular lung fluid, cardiac velocity time integral and inferior vena cava) on the commercial GE Vivid S70 Ultrasound System which are used to test feasibility of next generation ultrasound algorithms being developed to process these data types.
15992441|NCT02946216|Genetic|ctDNA analysis|
15992442|NCT02946203|Other|Barium Sulfate|Barium Sulfate Oral Contrast-VoLumen
15992443|NCT02946203|Other|Flavored beverage Oral Contrast|Flavored beverage for neutral abdominal/pelvic imaging
15992444|NCT02946190|Biological|Pertagen® aP + Td-pur®|see arm/group descriptions
15992445|NCT02946190|Biological|Boostrix® dTpa|see arm/group descriptions
15992446|NCT02946177|Biological|Influenza Vaccine|Inactivated influenza vaccine indicated for immunization against disease caused by influenza virus subtype A and type B present in the vaccine. Approved for use in persons 5 years of age and older. Single Dose prefilled 0.5 ml syringe.
15992447|NCT02946177|Other|Sterile Saline|0.5 mL of sterile Saline administered im
15992448|NCT02946164|Behavioral|Stick To It|The intervention is a prize system linked to points earned through online and real-world activities designed to incentivize young MSM to test for HIV and STIs every three months. Participants receive points for pre-determined activities, such as: answering online quizzes, inviting friends to participate, and getting tested for HIV/STIs. Points are redeemable in person at two AIDS Healthcare Foundation Men's Wellness Centers, where participants will be able to exchange their points for gumballs from a gumball machine; different color combinations of gumballs correspond to prizes of different values. Participants are reminded to get tested regularly via SMS messages; in addition, they can check when their next test is due by checking their testing timer on the stick2it.org website.
15992449|NCT02946151|Device|UNEEG implantable EEG electrode and data storage device|The implantable EEG electrode will be implanted subcutaneously in the relevant temporal region by a certified neurosurgeon. The EEGgraphical data recorded will be transmitted transcutaneously to the data storage device via an inductive link, providing continuous data on brain activity.
15992450|NCT02946138|Radiation|carbon-ion radiotherapy|Hypofractionated carbon-ion radiotherapy was prescribed at a dose of 40Gy RBE in 5 fractions
15992454|NCT02946099|Procedure|Reciproc files in reciprocating motion|An endodontic file that works through a reciprocating motion
15992455|NCT02946099|Procedure|ProTaper Next files in continuous rotary motion|An endodontic file that works through a continuous rotary motion
15992456|NCT02946086|Behavioral|HABIT-ILE with prismatic adaptation|Bimanual and locomotor intensive intervention for 90h including 8 hours of prismatic adaptation
15992457|NCT02946086|Behavioral|HABIT-ILE without prismatic adaptation|Bimanual and locomotor intensive intervention for 90h including 8 hours of prismatic adaptation wearing sham goggles.
15992458|NCT02946073|Drug|buprenorphine|
15992459|NCT02946073|Other|Placebo|
15992460|NCT02946060|Other|Audiobooks|iPods with audiobooks
15992461|NCT02946060|Other|Tempo-pace synchronized playlists|Playlists with or without RAS
15992462|NCT02946060|Other|Usual Care|iPods containing either a silent track or white noise
15992463|NCT02946047|Drug|Ixazomib|Patients Will be given oral Ixazomib on days 1, 8 and 15 of a 28 day cycle. Additional cycles, dosing days may be added and dose increased based on patient tolerability.
15992464|NCT02946034|Drug|Viekira Pak ± ribavirin|12 weeks treatment with AbbVie Viekira Pak ± ribavirin
15992465|NCT02946034|Drug|Mavyret|12 weeks treatment with AbbVie Mavyret
15992466|NCT02946021|Device|Head and neck garments for pneumatic compression device|Pneumatic compression device cleared for use by patients who are under medical supervision for the treatment of 1) lymphedema (primary or secondary); 2) edema resulting from mastectomies, trauma, sports injuries or post immobilization; 3) venous insufficiencies; 4) wounds; and 5) stasis dermatitis, venous stasis ulcers, arterial leg ulcers and diabetic foot ulcers and treatment of head and neck lymphedema
15992467|NCT02946021|Drug|NIRFLI with ICG|Near-infrared Fluorescence Lymphatic Imaging following the off-label use of Indocyanine Green as a lymph contrast agent and the use of a custom designed fluorescence imager to dynamically follow lymphatic movement in subjects.
15992468|NCT02946008|Radiation|Stereotactic Body Radiation Therapy|Delivered over 5 treatment sessions for approximately 1.5 weeks total.
15992469|NCT02946008|Procedure|Radical Prostatectomy|Open, laparoscopic, or robotic radical prostatectomy and pelvic lymph node dissection to remove the prostate, seminal vesicles, and pelvic lymph nodes.
15992470|NCT02945995|Procedure|hip arthroscopy|Follow up after hip arthroscopy in pt with previous PAO. Follow up by questionnaires send til the cohort
15992471|NCT02945982|Drug|Entecavir+Carvedilol|The subjects will be taking half a Carvedilol per day at first week and one Carvedilol per day from second week. At the same time,the subjects will be taking one Entecavir tablet per day for 96 weeks.
15992472|NCT02945982|Drug|Entecavir+Carvedilol+ Fuzheng Huayu|The subjects will be taking half a Carvedilol tablet per day at first week and one Carvedilol tablets per day from second week. At the same time,the subjects will be taking one Entecavir tablet per day and 4 Fuzheng Huayu tablets three times a day for 96 weeks.
15992473|NCT02945969|Behavioral|Low Sodium Diet|Once randomized to the Intervention program, study participants will be grouped into intervention cohorts of approximately 10 participants per group to facilitate group counseling sessions. Both the intensive intervention phase and the maintenance phase will include individual and group behavioral modification counseling designed to facilitate a reduction in dietary sodium intake. Success of the intervention will be assessed by comparing the urine sodium measurements from 24-hour urine collections performed at screening, 12 weeks and 24 weeks.
15992474|NCT02945956|Drug|Entecavir|The subjects will be taking 1 Entecavir tablet per day for 96 weeks.
15992475|NCT02945956|Drug|Entecavir + Fuzheng Huayu|The subjects will be taking 1 Entecavir tablet per day and 4 Fuzheng Huayu tablets three times a day for 96 weeks.
15992476|NCT02945943|Other|High Velocity Low Amplitude mobilization|Mobilizations were performed one time at each joint, prior to completing the exercise protocol during the first three treatment sessions.
15992477|NCT02945943|Other|Exercise Protocol|This exercise regimen is a modified version of the balance training program described by McKeon et al.
15992478|NCT02945904|Procedure|adrenalectomy|Unilateral adrenalectomy for Conn's adenoma
15992479|NCT02945891|Device|HPV testing of Evalyn®Brush, FloqSwab and Colli-Pee specimens|Each woman use the self-sampling devices in an advised order the day before they go to the hospital. There will be change of sampling order with every patient so that 50% of women will use Evalyn®Brush (Rovers Medical Devices, Oss, The Netherlands) first and 50% a FloqSwab (Coban Flock Technologies, Italy) first. In addition women are asked to provide a first void urine sample using a Colli-PeeTM (Novosanis, Belgium) on the same morning as the hospital visit. At the hospital clinician will take an additional specimen for which the performance of different self-sampling devices will be compared to.
15992480|NCT02945865|Other|Pain assessment|Pain assessment with assessment tools
15992481|NCT02945852|Drug|apatinib|apatinib 500mg/d until progressive Disease
15992482|NCT02945839|Drug|Preventative Medication (PM)|Subjects in the PM group will be given acute migraine medication, preventive medication (topiramate), and the APP with the PMR component. The smartphone app and/or the electronic pill bottles will be used to monitor adherence.
15992483|NCT02945839|Behavioral|Enhanced Usual Care|General Education Class consisting of basic migraine information of basic migraine information such as evidence-based ways to treat migraines: treat early, limit acute medications < 2-3 days/week, and call the primary care physician (PCP) if abortive medications are used more frequently.
15992484|NCT02945839|Behavioral|PMR (progressive muscle relaxation therapy)|Technique for learning to monitor and control the state of muscular tension
15992485|NCT02945826|Drug|One injection of 68Ga-NOTA-AE105|One injection of 68Ga-NOTA-AE105
15992486|NCT02945826|Device|PET/MRI|Following injection of 68Ga-NOTA-AE105 the patients will be subjected to PET/MRI of the brain
15992487|NCT02945813|Drug|Metformin|850mg PO BID; 48 weeks
15992488|NCT02945813|Radiation|Salvage Radiotherapy SRT|SRT 35 x 2Gy; 7 weeks
15992489|NCT02945800|Drug|nab-Paclitaxel|nab-Paclitaxel: 125 mg/m^2 intravenously (IV)
15992490|NCT02945800|Drug|Gemcitabine|Gemcitabine: 1000 mg/m^2 intravenously (IV)
15992491|NCT02945787|Behavioral|Spanish-Language Version of the Stop Smoking for Good|Participants in the first arm will receive the Spanish-language version of the Stop Smoking for Good (SS-SP) intervention distributed over 18 months.
15992492|NCT02945787|Behavioral|NCI-Produced Spanish-language Self-help Booklet|Participants in the second arm will receive a single, credible, NCI-produced Spanish-language self-help booklet.
15992493|NCT02945774|Radiation|(18F)-FEPPA|PET ligand that binds to activated microglia, a marker of neuroinflammation
15992494|NCT02945761|Procedure|High concentration of sugar solution|
15992495|NCT02945761|Procedure|conventional surgical dressing change|
15992496|NCT02945735|Behavioral|Attention Modification|Feedback according to participants' viewing patterns, in order to modify their attention.
15992497|NCT02945722|Drug|Decolonization|Decolonization schedule associate the use of mupirocin nasal ointment 3 times a day and chlorhexidine bath once a day for 5 days. Screening of persistent carriers will be done every 3 months
15992498|NCT02945722|Other|No decolonization|Screening of persistent carriers in this arm will be done every 3 months
15992499|NCT02945709|Behavioral|Personalized Attention control training (ACT)|In this intervention, participants will be trained with a personalized Dot-Probe task. Each participant will perform the task with the set of words that he or she ranked as the most threatening according to a Word Ranking Task.
15992500|NCT02945709|Behavioral|Non-personalized Attention control training (ACT)|"In this intervention, participants will be trained with the same Dot-Probe task as in the personalized condition, except that the word stimuli will be randomly fit for each participant. It should be noted that 25% out of the words in this condition will be high ranked words according to each patient's word ranking. The aim of this is to enhance similarity to a generic ACT intervention (see Badura-Brack et al., 2015), where there is some degree of exposure to what one may consider personalized stimuli (i.e., threat words that were randomly included by the researchers), although it is not deliberately set to idiosyncratic preferences."
15992501|NCT02945709|Behavioral|Control training.|In this intervention, participants will perform a computerized task, similar to the Dot-Probe task. In each trial, one neutral word will be presented at the center of the screen and participants will respond to a probe ('E' or 'f') presented following the removal of the words display. This version does not include the essential ingredients thought to reduce PTSD symptoms in the other dot-probe tasks: exposure to threat content and competition on attentional resources. Thus, this control version provides a control condition for the ACT interventions.
15992502|NCT02945696|Procedure|laparoscopic guided nerve blocks|It is common to use ultrasound to define the correct plane for abdominal wall nerve blocks, however, the utilization of laparoscopy to identify this plane is a new intervention that is previously undescribed in children.
15992503|NCT02945696|Drug|Ropivacaine|Ropivacaine is a local anesthetic used to prevent pain during and after procedures. In this study, ropivacaine will be injected either directly at the port sites, or for a regional abdominal wall nerve block, either under ultrasound or laparoscopic guidance.
15992504|NCT02945683|Dietary Supplement|Reuterin D3|Lactobacillus reuteri DSM 17938 (10E8 CFU in 5 drops), Vitamin D3 (400 IU in 5 drops), sunflower oil, medium chain triglycerides, silicon dioxide
15992505|NCT02945683|Dietary Supplement|Placebo|sunflower oil, medium chain triglycerides, silicon dioxide
15992506|NCT02945670|Behavioral|Focus Group|We had recruited 64 women and completed 7 focus group sessions
15992507|NCT02945657|Drug|MM36 topical ointment, 1%|Twice daily application for 28 consecutive days
15992508|NCT02945644|Drug|Trazodone|take at bedtime for 14 days
15992509|NCT02945644|Drug|Placebo|take at bedtime for 14 days
15992510|NCT02945631|Radiation|PTV56|total dose of 56 Gy in 2.0 Gy/fraction x 28 fractions.
15992511|NCT02945631|Radiation|PTV50.4|total dose of 50.4 Gy in 1.8 Gy /fraction x 28 fractions.
15992512|NCT02945618|Device|Neurocryostimulation|"CRYOFOS will be applied on the ankle at the end of each of the 8 sessions (in accordance to the protocol established). The treatment time with the CRYOFOS will take between 1 and 2 minutes, and will be pain-free.
~Both groups will also receive the same conventional program consisting of: compression, bracing, early mobilization (including manual therapy), strengthening (isometric and isotonic using elastic bands) and proprioception (using proprioception boards) exercises, according to the grade of the sprain and the stage of biological ligament healing."
15992513|NCT02945618|Other|Ice|The control group will receive the same conventional program (as the experimental group) consisting of: compression, bracing, early mobilization (including manual therapy), strengthening (isometric and isotonic using elastic bands) and proprioception (using proprioception boards) exercises, according to the grade of the sprain and the stage of biological ligament healing. Ice will be applied to the ankle for 15 minutes at the end of each of the 8 sessions.
15992514|NCT02945605|Other|Early Vestibular Rehabilitation|"Two visits/week for a maximum of 5 weeks will be provided with the approximate duration for each visit estimated at 50-60 minutes. Consistent with a previously validated framework for exercise prescription in patients with concussion, the exercises provided by the treating therapist can be classified into five main exercise categories:
~Eye-Head coordination, gaze stability and convergence exercises
~Sitting balance
~Standing static balance (i.e. feet-in-place)
~Dynamic balance (feet moving, but not walking)
~Ambulation (gait exercises)
~Other exercises: Sport specific exercises, Canalith repositioning maneuvers are recorded as others"
15992515|NCT02945605|Other|Standard of Care|Standard care as directed by a physician.
15992516|NCT02945592|Behavioral|Cueing|
15992517|NCT02945579|Radiation|External Beam Radiation Therapy|Undergo EBRT
15992518|NCT02945579|Other|Laboratory Biomarker Analysis|Correlative studies
15992519|NCT02945579|Other|Quality-of-Life Assessment|Ancillary studies
15992520|NCT02945579|Other|Questionnaire Administration|Ancillary studies
15992521|NCT02945579|Radiation|Whole Breast Irradiation|Undergo whole breast irradiation
15992522|NCT02945566|Procedure|Standard TME surgery|Total mesorectal excision
15992523|NCT02945566|Drug|Long course concurrent chemoradiation|Capecitabine 825 mg/m² orally, b.i.d., on radiotherapy days. Radiotherapy: A dose of 50 Gy, applied to the primary tumour and surrounding mesorectum, in 25 fractions of 2 Gy, 5 days a week.
15992524|NCT02945566|Radiation|Short course radiotherapy|A dose of 25Gy, applied, to the primary tumour and surrounding mesorectum in 5 fractions of 5 Gy, 5 days a week.
15992525|NCT02945553|Device|Neuromuscular electrical stimulation|Neuromuscular electrical stimulation (NMES) will be performed 5 times/week for one hour each day. NMES will start within 1 week of injury and continue till 3 weeks following surgery.
15992526|NCT02945553|Device|Microstimulation|Microstimulation will be performed 5 times/week for one hour each day. Microstimulation will start within 1 week of injury and continue till 3 weeks following surgery.
15992527|NCT02945527|Drug|Acetazolamide|As described above
15992529|NCT02945514|Other|DayTwo machine learning algorithm|Personally tailored nutrition insights based on DayTwo machine learning algorithm when combining facets of your postprandial glycemic response to food consumed during collection week and your individual gut microbiome composition
15992530|NCT02945501|Device|NeuroConn DC Stimulator PLUS|Prior to bedtime on the sleep restriction night, 4 transcranial stimulation electrodes (two on each hemisphere) will be applied to the scalps of each subject. Subjects will receive a one hour period of SO stimulation, for a total of approximately two hours of sleep.
15992531|NCT02945501|Device|SHAM TES|Prior to bedtime on the sleep restriction night, 4 placebo transcranial stimulation electrodes (two on each hemisphere) will be applied to the scalps of each subject. Subjects will sleep for approximately 2 hours without stimulation.
15992532|NCT02945488|Other|Exercise|Exercise intervention will entail 30 minutes of moderate intensity cardiovascular training 3 days/week and full body resistance training 2 days/week (supervised). Cardiovascular training will entail any weight-bearing activity that would achieve target heart rate, such as walking, jogging, stair climbing, dancing, etc. Resistance training will entail 2-3 sets of 8-12 repetitions of exercises targeting all major muscle groups with an external load applied, such as a dumbbell, barbell, medicine ball, etc.
15992533|NCT02945488|Other|Dietary plan|Mediterranean dietary plan, which contains foods, such as fish, vegetables, nuts, and oils, which are anti-inflammatory in nature.
15992534|NCT02945488|Other|Stretching|Stretching intervention will entail 30 minutes of flexibility training 3 days/week of stretches targeting all major muscle groups held for 20-30 seconds.
15992535|NCT02945462|Biological|autologous mesenchymal stem cells|Patients will be injected with autologous mesenchymal stem cells, intracavernously
15992536|NCT02945449|Biological|Wharton Jelly Mesenchymal stem cells|Intracavernous injection of Wharton Jelly Mesenchymal stem cells.
15992537|NCT02945436|Behavioral|Substance Use Brief Intervention|SUBI is a counseling intervention based on Motivational Interviewing techniques that focuses on the substance use and sexual health risks of participants.
15992538|NCT02945436|Behavioral|Standard of Care (SOC)|Standard of care is Counseling Testing and Referral (CTR). CTR is a standardized service in which counselors provide HIV testing, risk-related counseling and appropriate referrals (medical, social, prevention, and partner services) to clients.
15992539|NCT02945410|Other|Caloric Restriction|Participants will consume 30 kcal/kg FFM/day.
15992540|NCT02945410|Other|Protein|Participants will consume 1.7 g protein/kg BW/day.
15992541|NCT02945410|Other|Exercise|Participants will conduct aerobic exercise designed to expend 15 kcal/kg FFM/day
15992542|NCT02945410|Dietary Supplement|Calcium and Vitamin D|Participants will be provided calcium and vitamin D supplement in order to maintain calcium and Vitamin D intake constant across all study arms
15992543|NCT02945410|Other|Maltodextrin|Participants will be provided with maltodextrin to supplement the liquid diet in order to meet caloric needs within each study arm
15992544|NCT02945397|Behavioral|Group-based activity|Regular follow-up from welfare authority as well as a 3 month group activity with weekly gatherings, focusing on coping, goal-setting and relevant information regarding available public services.
15992545|NCT02945397|Behavioral|Individual activity|Regular follow-up from welfare authority as well as a 3 month membership card at a given gym.
15992546|NCT02945384|Behavioral|Creating Connections: Strong Families, Strong Brains|Dual-generation intervention
15992547|NCT02945371|Behavioral|Person-centered inhibitory control training|A brief, computer-based, multisession training aimed at increasing the connection between environmental risk cues (e.g., cigarettes) and engagement of the brain network for inhibitory control.
15992548|NCT02945371|Behavioral|Active behavioral response training|A brief computer-based, multisession training aimed at training behavioral responses to personalized environmental risk cues (e.g., cigarettes) that does not engage the inhibitory control network of the brain.
15992549|NCT02945358|Procedure|adult cardiac surgery with cardiopulmonary pump|Open-heart surgery both coronary artery bypass graft (CABG) and valve surgery
15992550|NCT02945332|Behavioral|Required supervised walking|The intervention will include meeting at an agreed upon community center location and time convenient for both the participant and the researcher. During these meetings, the participants will engage in indoor walking under the supervision of the researcher. This is to ensure accurate walking distance recording and also to monitor the participants for any potential adverse events. The participants will have the option of walking as long or short as they please, so long that it is less than 20 miles per week. This is to protect the participants from exhaustion or overexertion. Overall activity of this group will be recorded using Fitbit Flexes, worn at all time for the duration of the study.
15992551|NCT02945332|Behavioral|Non-required supervised walking|The intervention will include meeting at an agreed upon community center location and time convenient for both the participant and the researcher. During these meetings, the participants will engage in indoor walking under the supervision of the researcher. This is to ensure accurate walking distance recording and also to monitor the participants for any potential adverse events. The participants will have the option of walking as long or short as they please, so long that it is less than 20 miles per week. This is to protect the participants from exhaustion or overexertion. Overall activity of this group will be recorded using Fitbit Flexes, worn at all time for the duration of the study.
15992552|NCT02945332|Device|Fitbit Flex|
15992553|NCT02945306|Procedure|Adenotonsillectomy|
15992554|NCT02945306|Drug|Watchful waiting with supportive care|Use of widely prescribed medicines to treat associated conditions
15992555|NCT02945293|Other|Oxycodone|This study is interventional. Participants are given a single, one time administration of medication 10mg of oxycodone and observed
15992556|NCT02945280|Drug|apixaban|12 weeks of apixaban treatment to monitor for efficacy in the prevention of VTE-related mortality
15992557|NCT02945267|Drug|Nimotuzumab plus S1|Nimotuzumab Injection: 400 mg/w, Intravenous infusion, Infusion time ≥ 60 min, d1, once every two weeks;S1: 40 mg (Body surface area<1.5 m2) or 60 mg (Body surface area>1.5 m2) ,oral,d1-d14, every three weeks for a cycle
15992558|NCT02945267|Drug|Placebo plus S1|Placebo: 400 mg/w, Intravenous infusion, Infusion time ≥ 60 min, d1, once every two weeks;S1: 40 mg (Body surface area<1.5 m2) or 60 mg (Body surface area>1.5 m2) ,oral,d1-d14, every three weeks for a cycle
15992559|NCT02945254|Device|NIghtingale (R) device for filtered white noise (Cambridge Sound Management, Waltham, MA)|
15992560|NCT02945241|Drug|Vancomycin|Intravenous
15992561|NCT02945241|Other|Cystatin C dosing algorithm|Expressed in milliliters per minute
15992562|NCT02945241|Other|Creatine clearance dosing algorithm|Vancomycin dosing algorithm based on creatinine clearance, expressed in milliliters per minute
15992563|NCT02945215|Drug|IBI301|IBI301 375mg/㎡
15992564|NCT02945215|Drug|Rituximab|Rituximab 375mg/㎡
15992565|NCT02945202|Device|Biometry|All patients undergo all three examinations (biometry, refraction and corneal topography) 6 months after surgery
15992566|NCT02945202|Device|Refraction|All patients undergo all three examinations (biometry, refraction and corneal topography) 6 months after surgery
15992567|NCT02945202|Device|Corneal Topography|All patients undergo all three examinations (biometry, refraction and corneal topography) 6 months after surgery
15992568|NCT02945176|Device|ARGOS-IO system|This study will enroll a minimum of 10 and a maximum of 15 patients. It is anticipated to be large enough to provide an initial estimate of common safety events and assessment of performance. Any adverse event (AE), serious adverse event (SAE), ADE (adverse device event) and SADE (serious adverse device event) will be listed. Incidence will be estimated with a 95% confidence interval (Pearson-Clopper, two-sided). The Bland-Altman method will be used to assess the limits of agreement between the IOP measurements ARGOS-IO and surgical manometry. When appropriate, two-sided 95% confidence intervals, for these limits will be calculated accounting for repeated measurements based on the method proposed by Zou (2011). Other secondary performance endpoints will be analyzed by descriptive and explorative statistical methods.
15992569|NCT02945163|Drug|Tenofovir|Tenofovir Disoproxil Fumarate
15992570|NCT02945163|Drug|Lamivudine|Lamivudine
15992571|NCT02945163|Drug|Efavirenz|Efavirenz
15992572|NCT02945150|Drug|elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination)|"Elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor
~Subjects receive first dose on-call to operating room, and continue daily for 12 weeks. Treatment length is extended to 16 weeks and ribavirin (daily dose 1000 mg for those <75 kg and 1200 mg for those ≥75 kg) if subject receives a kidney from a donor who is infected with HCV containing resistance-associated variants (RAV)."
15992573|NCT02945124|Other|K tape|Applying K tape to children to the lower limb muscles during motor activities.
15992574|NCT02945111|Behavioral|Real-time view|
15992575|NCT02945111|Behavioral|No visual support|
15992576|NCT02945098|Other|Kinesio Taping|Kinesio Taping application with tension (Kinesio Tex Gold®, Japan) in the anterior region of the non-dominant arm.
15992577|NCT02945098|Other|Placebo Kinesio Taping|Kinesio Taping application without tension (Kinesio Tex Gold®, Japan) in the anterior region of the non-dominant arm.
15992578|NCT02945085|Other|Home Based Care Team|Clinical team will conduct comprehensive clinical assessments focused on cognitive impairment and depression, conduct comprehensive medication review and reconciliation, offer Problem Solving Therapy, and offer brief occupational therapy, physical therapy, nutrition, and social support services.
15992579|NCT02945085|Other|Telephone Based Care Team|Telephone contact will be made by nurses. Depending on level of need, follow up telephone and, in some cases, in home visits will be made by nurse or social worker from care management program.
15992580|NCT02945072|Procedure|TIVA|TIVA is use to anesthesia maintenance after anesthesia induction (Propofol 10mg/kg/h, Remifentanil 0.2mcg/kg/min, dose adaptation as required for sufficient anesthesia)
15992581|NCT02945072|Procedure|Sevoflurane|Sevoflurane is use to anesthesia maintenance after anesthesia induction (target et 2 Vol% in 50-70% N2O, dose adaptation as required)
15992582|NCT02945059|Procedure|Selective reversible portal vein embolization|Percutaneous access to the portal vein is achieved under general anesthesia with ultrasound or fluoroscopic control. After assessment of portal venous anatomy, embolization of selected portal vein segments is performed using the powdered form of an absorbable gelatin sponge.
15992583|NCT02945046|Drug|Fremanezumab|Fremanezumab will be administered per dose and schedule specified in the arm.
15992584|NCT02945046|Drug|Placebo|Placebo matching to fremanezumab will be administered per schedule specified in the arm.
15992585|NCT02945033|Drug|aspirin intake|Patient with colonic adenocarcinoma stage III or II high risk will take aspirin 100 mg/day during 3 years
15992586|NCT02945033|Drug|placebo intake|Patient with colonic adenocarcinoma stage III or II high risk will take placebo of aspirin 100 mg/day during 3 years
15992587|NCT02945033|Procedure|Surgical resection of colonic adenocarcinoma stage III or II high risk|Surgical resection of colonic adenocarcinoma stage III or II high risk will be done in accordance with local guidelines
15992588|NCT02945033|Biological|Molecular analysis of exon 9 and 20 of PI3K|Molecular analysis of exon 9 and 20 of PI3K will be done using operative piece
15992589|NCT02945033|Biological|blood intake|Blood intake will be done every 6 months to evaluate patient compliance to treatment
15992590|NCT02945020|Drug|Dabigatran etexilate mesylate|Participants will receive dabigatran etexilate mesylate 75 mg, orally.
15992591|NCT02945020|Drug|Odalasvir (ODV)|Participants will receive ODV 25 mg, orally.
15992592|NCT02945020|Drug|Simeprevir (SMV)|Participants will receive SMV 75 mg, orally.
15992593|NCT02945007|Drug|JNJ-53718678|Participants will receive JNJ-53718678 under fed or fasted conditions.
15992594|NCT02944994|Other|Unified protocol|This is a transdiagnostic cognitive behavioral therapy
15992595|NCT02944994|Other|Routine Care|This arm will reflect typical care received in routine mental health care
15992596|NCT02944981|Drug|Gabapentin|Single oral dose
15992597|NCT02944981|Drug|Placebo|Single oral dose
15992598|NCT02944968|Device|THERMOCOOL SMARTTOUCH® SF-5D catheter|
15992599|NCT02944955|Drug|BLEX 404 Oral Liquid|"BLEX 404 Oral Liquid is orally administered twice daily in combination with azacitdine treatment cycles (2 cycles in Part I and 6 cycles in Part II).
~Azacitidine treatment: SC or IV injections at 75 mg/m2, QD for 7 days each cycle. 28 days/cycle, and repeat cycles every 4 weeks."
15992600|NCT02944942|Procedure|General anesthesia|Patients undergoing general anesthesia
15992601|NCT02944929|Other|Self-rehabilitation program|The self-rehabilitation program will be based on muscle stretching, strengthening and task oriented exercises. For each patient, two exercises will be selected by the therapist for each of these 3 domains (total of 6 exercises) from a list of 50 exercises.
15992602|NCT02944916|Device|IryPump R Set|
15992603|NCT02944903|Other|Audit|Questionnair
15992604|NCT02944890|Device|Drug Eluting Balloon Catheters(RESTORE DEB）|
15992605|NCT02944890|Device|Drug Eluting Balloon Catheters(SeQuent® Please）|
15992606|NCT02944877|Behavioral|social media intervention|social media intervention
15992607|NCT02944864|Drug|TQ-B3395|TQ-B3395 p.o. qd
15992608|NCT02944838|Behavioral|Senior Change Makers Advocacy Program|see description
15992609|NCT02944838|Behavioral|Senior Change Makers Physical Activity Program|see description
15992610|NCT02944825|Drug|Ciprofloxacin|first line prophylactic oral antibiotic
15992611|NCT02944825|Drug|trimethoprim/sulfamethoxazole|second line prophylactic oral antibiotic
15992612|NCT02944825|Drug|No Intervention|No intervention
15992613|NCT02944812|Drug|Chidamide|Chidamide is given to the patients as described, and drug concentration is measured in patients' serum and CSF, also, parameters concerning efficacy and safety are also obtained.
15992614|NCT02944799|Drug|Placebo|Discontinuation of alendronate treatment
15992615|NCT02944799|Drug|Alendronate|
15992616|NCT02944799|Drug|Calcium|Daily dietary supplement of 800mg calcium
15992617|NCT02944799|Drug|Vitamin D|Daily dietary supplement of 38 micrograms vitamin D
15992618|NCT02944786|Behavioral|HOPE-model|There are four sessions of person-centered health dialogues. The sessions also include pain/stress management and education about stress and pain (the HOPE model that is an adolescent-centered school health prevention program when adolescents have chronic pain).
15992619|NCT02944773|Procedure|Facilitated tucking device|20 newborns are using a facilitated tucking device weight during the procedure to assess the level of stress
15992620|NCT02944760|Other|Low-Level Light Therapy|The application of laser therapy will take place 30 minutes before the start of dialysis. The application will take place with the Chattanooga device, with the laser diode cluster probe from the same manufacturer consisting of five diodes 850 nm and power output of 200 mW. It is irradiated 6 points in quadriceps and 4 points in gastrocnemius, bilaterally by 30 seconds. The patient will be supine on a stretcher to the implementation of the intervention.
15992621|NCT02944747|Behavioral|Education & paper based calendar|The participants will be counseled on importance of remembering LMP. In addition, they will be provided a free calendar to record their LMP dates.
15992622|NCT02944747|Behavioral|Education & SMS system|The participants will be counseled on importance of remembering LMP. They will be asked to send the LMP date via SMS. Participants will be reminded via SMS if they have not sent their dates (max -3 reminders)
15992623|NCT02944747|Behavioral|Education & smart-phone application|The participants will be counseled on importance of remembering LMP. Participants will be asked to record the LMP on a calendar app. This will be transferred to central server via internet Participants will be reminded via SMS if they have not sent their dates (max -3 reminders)
15992624|NCT02944734|Drug|Candesartan Cilexetil 8mg|Candesartan Cilexetil 8mg Daily oral administration for 8 weeks
15992625|NCT02944734|Drug|Candesartan Cilexetil 16mg|Candesartan Cilexetil 16mg Daily oral administration for 8 weeks
15992626|NCT02944734|Drug|Amlodipine 5mg|Amlodipine 5mg Daily oral administration for 8 weeks
15992627|NCT02944734|Drug|Amlodipine 10mg|Amlodipine 10mg Daily oral administration for 8 weeks
15992628|NCT02944721|Genetic|Genetical analyses|
15992629|NCT02944721|Other|Chronic pain identification questionnaires|
15992630|NCT02944721|Other|Neurophysiological and psychophysical evaluations|
15992631|NCT02944721|Other|Quality of life questionnaires|
15992632|NCT02944708|Drug|Conventional chemotherapy|
15992633|NCT02944708|Drug|Maintenance chemotherapy 1|
15992634|NCT02944708|Drug|Maintenance chemotherapy 2|
15992635|NCT02944695|Other|audit|Practice adherence to guidelines
15992636|NCT02944682|Other|Liquefied petroleum gas (LPG) cookstove|The intervention consists of a high-quality locally-available liquefied petroleum gas (LPG) stove having at least two burners, a continuous supply of LPG fuel for 18 months, and the promotion of stove use on an exclusive basis for cooking. The intervention will be provided free of charge to all intervention households upon enrollment. On a weekly basis, study staff will examine stove condition, perform any repairs necessary, and measure and record weight of LPG tanks in order to anticipate need for refills.
15992637|NCT02944669|Device|ReWalk Personal Device|
15992638|NCT02944656|Drug|Gabapentin|Participants in this group will receive 600 mg of gabapentin given 1-2 hours pre-operatively in conjunction with perioperative paracervical block for surgical abortion. Gabapentin is an FDA approved medication that is used to prevent seizures and to treat various forms of chronic and acute pain.
15992639|NCT02944656|Drug|Placebo|Participants in this group will receive 600 mg of gelatin capsules that are identical in appearance to gabapentin capsules. The placebo will be given 1-2 hours pre-operatively in conjunction with perioperative paracervical block for surgical abortion.
15992640|NCT02944643|Other|Mindfulness and Support Groups|
15992641|NCT02944630|Behavioral|Psychotherapy|Individual psychotherapy
15992642|NCT02944617|Other|Laboratory Biomarker Analysis|Correlative studies
15992643|NCT02944617|Dietary Supplement|Micronutrient-Fortified Probiotic Yogurt|Receive Activia yogurt
15992644|NCT02944617|Drug|VEGF-TKI|Must be received as standard of care chemotherapy
15992645|NCT02944604|Drug|PEG-rhG-CSF|
15992646|NCT02944591|Device|COPD Co-Pilot|The COPD Co-PilotTM is a smartphone application for symptom reporting supported by a Call Center staffed with pulmonary nurses and Health Assistants who are trained to support patients with COPD. The call center staff are employees and subcontractors of the company that makes the COPD Co-PilotTM, HGE. It is located on the Campus of Temple University in Philadelphia Pennsylvania.
15992687|NCT02944292|Drug|Propofol|"Propofol will be dosed according to lean body weight (LBW) for bolus administration and according to total body weight (TBW) for continuous infusion.
~All patients will receive a bolus of propofol 1 mg/kg LBW as a rapid infusion during one minute. Measurements will be made one minute after the ending of bolus infusion. Continuous infusion of propofol at a rate of 3 mg/kg/h will be started immediately following completion of measurements, not later than 5 minutes after bolus administration. The propofol infusion rate is decreased in case of hemodynamic instability by 1 mg/kg/h and until a minimum of 1 mg/kg/h, if needed. Maximum total dose of infusion of 5 mg/kg/h will not be exceeded (bolus not considered)."
15993482|NCT02938494|Drug|Tazorac Cream|Cream
15992647|NCT02944578|Drug|Curcumin|"Curcumin (Curcumin C3 Complex®, prepared by Sabinsa Corporation), a constituent of the spice turmeric, is considered to be a low-toxicity, dietary-derived agent with chemopreventive and therapeutic benefits.
~Study participants will be instructed to insert four 500 mg (2000 mg total) curcumin capsules once a week (excluding days when they are on their menses). Participants will insert the capsules using the vaginal applicator while lying on their back with their knees bent. Participants will be instructed to gently insert the capsules into the vagina as far as they will go comfortably, similar to a tampon insertion or other common intravaginal drugs.
~Cervical cytology, colposcopies and biopsies will be performed at the Baseline, Week 4, 8, 12 and 16 visits to collect samples to analyze for the study outcomes."
15992648|NCT02944578|Drug|Placebo|"Study participants randomized to the placebo arm will insert four 500 mg (2000 mg total) of the placebo (gelatin) capsules once a week (excluding days when they are on their menses). Participants will insert the capsules using the vaginal applicator while lying on their back with their knees bent. Participants will be instructed to gently insert the capsules into the vagina as far as they will go comfortably, similar to a tampon insertion or other common intravaginal drugs.
~Cervical cytology, colposcopies and biopsies will be performed at the Baseline, Week 4, 8, 12 and 16 visits to collect samples to analyze for the study outcomes."
15992649|NCT02944565|Biological|Daratumumab|Given IV
15992650|NCT02944552|Drug|bicyclol tablet 25mg|Patients in the low dose group administrated bicyclol tablet 25mg, one bicyclol blank analog tablet and two polyene phosphatidylcholine blank analog capsules orally, three times daily for 4-8 weeks.
15992651|NCT02944552|Drug|bicyclol tablet 50mg|Patients in the high dose group administrated bicyclol tablet 50mg and two polyene phosphatidylcholine blank analog capsules orally, three times daily for 4-8 weeks.
15992652|NCT02944552|Drug|polyene phosphatidylcholine capsule 456mg|Patients in the positive drug control group administrated polyene phosphatidylcholine capsules 456mg and two bicyclol blank analog tablets orally, three times daily for 4-8 weeks.
15992653|NCT02944526|Drug|Ropivacaine Monohydrochloride|Suprascapular nerve block under ultrasound control: injection of 5ml Ropivacaine HCL 2mg /ml
15992654|NCT02944526|Drug|Placebo - Concentrate|Placebo suprascapular nerve block under ultrasound control: injection of 5ml physiological / isotonic saline
15992655|NCT02944513|Device|Quell|
15992656|NCT02944500|Drug|liraglutide|
15992657|NCT02944500|Other|Placebo|
15992658|NCT02944487|Drug|Lucerastat|Hard gelatin capsule for oral administration containing lucerastat
15992659|NCT02944487|Drug|Placebo|Matching placebo capsules
15992660|NCT02944474|Drug|Lucerastat|Capsule for oral administration containing lucerastat
15992661|NCT02944474|Drug|Placebo|Placebo capsules matching lucerastat capsules
15992662|NCT02944461|Drug|Dapsone 7.5 % gel|Dapsone gel 7.5% applied once daily to truncal acne
15992663|NCT02944448|Drug|CR845 tablet 1 mg|CR845 tablets will be provided as 1 mg enteric-coated tablets. All tablets are white in color with no markings and are identical in appearance, regardless of dose and treatment.
15992664|NCT02944448|Drug|CR845 tablet 2.5 mg|CR845 tablets will be provided as 2.5 mg enteric-coated tablets. All tablets are white in color with no markings and are identical in appearance, regardless of dose and treatment.
15992665|NCT02944448|Drug|CR845 tablet 5 mg|CR845 tablets will be provided as 5 mg enteric-coated tablets. All tablets are white in color with no markings and are identical in appearance, regardless of dose and treatment.
15992666|NCT02944448|Drug|Placebo tablet|Placebo tablets will be provided as enteric-coated tablets. All tablets are white in color with no markings and are identical in appearance, regardless of dose and treatment.
15992667|NCT02944435|Drug|CB-839 Capsules|3 x 200 mg CB-839 Capsules (Reference Formulation)
15992668|NCT02944435|Drug|CB-839 Tablets|3 x 200 mg CB-839 Tablets (Test Formulation)
15992669|NCT02944409|Device|total knee prothesis VEGA System|total knee replacement
15992670|NCT02944396|Drug|pemetrexed|intravenous; administered on Day 1 via infusion in a 21-day cycle
15992671|NCT02944396|Drug|nivolumab|intravenous; administered on Day 1 via infusion in a 21-day cycle
15992672|NCT02944396|Drug|paclitaxel|intravenous; administered on Day 1 via infusion in a 21-day cycle
15992673|NCT02944396|Drug|veliparib|oral capsule; varying doses administered on Days -2 to 5 in a 21-day cycle
15992674|NCT02944396|Drug|carboplatin|intravenous; administered on Day 1 via infusion in a 21-day cycle
15992675|NCT02944383|Drug|Gemcabene|Gemcabene tablets administered orally once daily, for 12 weeks.
15992676|NCT02944383|Drug|Placebo|Placebo tablets administered orally once daily, for 12 weeks.
15992677|NCT02944370|Behavioral|PlayFit - modified exercise games|Play modified games with other adults three times a week for 12 weeks. Complete a brief survey on the games played and program satisfaction.
15992678|NCT02944357|Drug|Cisplatin|Given IV
15992679|NCT02944357|Drug|Gemcitabine Hydrochloride|Given IV
15992680|NCT02944357|Procedure|Radical Cystectomy|Undergo cystectomy
15992681|NCT02944357|Biological|Tumor Cell-Derived Vaccine Therapy|Given AGS-003-BLD ID
15992682|NCT02944344|Behavioral|Four Conversations|The online Four Conversations program consists of tutorial videos, printable documents, and live sessions with a counselor to educate subjects on shared decision making and care planning for those with advanced disease.
15992683|NCT02944331|Procedure|Endovenous steam ablation|
15992684|NCT02944318|Behavioral|The Movement Program|The program duration will be one academic year (around ten months) in 2017. The intervention strategies will focus on: (1) teachers' training and activities on health in curriculum; (2) active opportunities in the school environment (facilities and materials for PA practice) and (3) health education (posters and folders to students and parents).
15992685|NCT02944305|Procedure|Endotracheal intubation|Endotracheal intubation under direct laryngoscopy using McIntosh blade
15992686|NCT02944292|Procedure|Deepening of sedation|Deepening of sedation will be achieved with a bolus and subsequent continuous infusion of propofol.
15992688|NCT02944266|Other|Pre operative Focus assessed Transthoracic echocardiographic assessment.|
15992689|NCT02944253|Other|Low energy diet 70 gram carbohydrates|isocaloric 4128 kilojoules/day (1000 kilocalories/day) for men and women, low energy diet containing 70 gram carbohydrates
15992690|NCT02944253|Other|Low energy diet 100 gram carbohydrates|isocaloric 4128 kilojoules/day (1000 kilocalories/day) for men and women
16007199|NCT02833883|Drug|CC-115|
15992691|NCT02944253|Other|Low energy diet 130 gram carbohydrates|isocaloric 4128 kilojoules/day (1000 kilocalories/day) for men and women, low energy diet containing 130 gram carbohydrates
15992692|NCT02944227|Drug|Lucentis|Lucentis fixed-treatment arm
15992693|NCT02944214|Drug|Febuxostat|It acts as an inhibitor of xanthine oxidase, thus lowering urate concentrations in the body
15992694|NCT02944214|Drug|Benzbromarone|It is structurally related to the antiarrhythmic amiodarone, and it is a uricosuric agent and non-competitive inhibitor of xanthine oxidase
15992695|NCT02944201|Drug|Carvedilol|Carvedilol will give twice daily until prostatectomy
15992696|NCT02944188|Procedure|Laparoscopic right hemicolectomy plus ERAS|patients treated with Laparoscopic right hemicolectomy plus enhanced recovery after surgery (ERAS) programs
15992697|NCT02944188|Procedure|Open right hemicolectomy plus ERAS|patients treated Open right hemicolectomy plus enhanced recovery after surgery (ERAS) programs
15992698|NCT02944175|Drug|Sugammadex|At the end of surgery and when 2 responses were achieved on the TOF stimulation, Sugammadex 2 mg·kg-1 was administered intravenously in Group S
15992699|NCT02944175|Drug|Neostigmine|At the end of surgery and when 2 responses were achieved on the TOF stimulation neostigmine 0.05 mg·kg-1 + atropine 0.02 mg·kg-1 was administered intravenously
15992700|NCT02944162|Biological|anti-CD33 CAR-NK cells|The allogeneic NK cells (NK-92 cell line for clinical use) are engineered to contain anti-CD33 attached to TCRzeta, CD28 and 4-1BB signaling domains. These modified cells are called chimeric antigen receptor NK cells with specificity for CD33.
15992701|NCT02944149|Procedure|tubal ligation by minilaparotomy|Tubal ligation will be performed by minilaparotomy as per the Tanzanian government standards, with the standard family planning counseling and minilaparotomy surgical protocols used by the government being followed during the study.
15992704|NCT02944123|Drug|Clopidogrel 75 mg|Clopidogrel 600 mg as loading dose followed by 75 mg/day as maintenance dose.
15992705|NCT02944123|Drug|Prasugrel 5 mg|Loading / maintenance dose: prasugrel 60 mg / 10 mg/day; After 1-month treatment of conventional dose, followed half dose of 5 mg/day for chronic treatment.
15992706|NCT02944123|Drug|Ticagrelor 45 mg|Loading / maintenance dose: ticagrelor 180 mg / 90 mg/bid; After 1-month treatment of conventional dose, followed half dose of 45 mg/bid for chronic treatment.
15992707|NCT02944110|Drug|Glucagon receptor antagonist LY2409021|single oral dose of 300mg
15992708|NCT02944110|Drug|Placebo|Oral dose of placebo tablets
15992709|NCT02944097|Dietary Supplement|Vineatrol 30 native powder|
15992710|NCT02944097|Dietary Supplement|Vineatrol 30 micelles|
15992711|NCT02944084|Dietary Supplement|Rice bran extract|
15992712|NCT02944084|Dietary Supplement|Porridge in water|
15992713|NCT02944084|Dietary Supplement|Porridge in milk|
15992715|NCT02944058|Procedure|Multiloc nail|Intervention is surgery with Multiloc nail
15992716|NCT02944058|Procedure|Philos plate|Intervention is surgery with Philos plate
15992717|NCT02944045|Drug|Methylprednisolone|"Methylprednisolone intra veinous
~Day 1 to 5 : 30mg twice per day
~Day 6 to 10 : 30mg per day
~Day 11 to 21 : 20mg per day"
15992718|NCT02944045|Drug|Placebo|saline serum
15992719|NCT02944032|Other|CogmedRM|Cogmed RM is a computer program that consists of twelve visually-engaging and interesting exercises that target skills involving visuo-spatial and verbal Working Memory. Difficulty of the tasks is automatically adjusted on a trial-by-trial basis throughout each training session to match a child's current working memory span, such that as the child becomes more proficient, the exercises become more difficult. During the intervention, children complete 25 training sessions. Children are asked to complete between 3 and 5 sessions per week, so the total treatment time to complete 25 sessions may range from 5 to 9 weeks. For children completing CogmedRM, sessions typically last between 25 and 45 minutes, depending on the child's working memory span.
15992720|NCT02944032|Other|Mobymax|"MobyMax's Reading Stories program is a program that focuses on reading comprehension skills. Participants will start their training with stories that are matched to their reading grade level. Each grade contains 30 lessons, with 3 stories in each lesson. Participants are given questions to answer at the conclusion of each story, and children advance or remain at that level depending on the progression of their reading skill. Participants randomized to this program will be asked to train 30-45 minutes per session for 25 training sessions over a 5 to 9 week period."
15992721|NCT02944019|Drug|Edoxaban|Prescribed according to approved label
15992722|NCT02944006|Procedure|multi-parametric MRI|multiparametric MRI is performed in all patients, and the sequence includes dynamic contrast enhanced (DCE) MRI, diffusion weighted imaging (DWI), tissue maps, and MR cholangiography.
15992723|NCT02943993|Drug|Edoxaban|Prescribed according to approved label
15992724|NCT02943980|Device|CMAC Videolaryngoscope|In a randomised order we evaluate the quality of the IONM after securing the airway with the CMAC
15992725|NCT02943980|Device|Macintosh Laryngoscope|In a randomised order we evaluate the quality of the IONM after securing the airway with the conventional Macintosh Laryngoscope
15992726|NCT02943967|Procedure|CXL + PRK group|Corneal cross-linking with subsequent photorefractive keratotomy after 6 months was performed in one eye
15992727|NCT02943967|Procedure|PRK group|Photorefractive keratotomy alone was performed in contra lateral eyes
15992728|NCT02943954|Procedure|Angiography guided PCI|
15992729|NCT02943954|Device|Fractional Flow Reserve (FFR)|
15992730|NCT02943941|Other|Reveal LINQ ICM Cardiac Monitor, taped on the subject's chest rather than inserted in the body.|Cardiac Monitor with LINQ™ HF Investigational RAMware download
15992731|NCT02943928|Device|laryngoscope and chest CT image|First,the operator calculate the distance between the carina and the glottis by CT image and make s marker on the double lumen endotracheal tube. Then the operator when inserted into the double lumen tube under the visualof laryngoscope until see marker just at the glottis
15992732|NCT02943928|Device|traditional method by experience|Operator inserted the double lumen tube by experience
15993483|NCT02938494|Drug|Vehicle Lotion|Lotion
15992733|NCT02943915|Device|Ekso GT Rehabilitation Therapy|Walking Improvement for Spinal Cord Injuries with Exoskeleton
15992734|NCT02943915|Device|Body Weight Supported (BWS) Treadmill Training|Standard gait training using BWS PT and overground training
15992735|NCT02943902|Biological|Pneumococcal conjugate vaccine (PCV10 ) 1+1, 6 weeks|PCV10 1+1, 6 weeks & 9 months
15992736|NCT02943902|Biological|Pneumococcal conjugate vaccine (PCV10 ) 1+1, 14 weeks|PCV10 1+1, 14 weeks & 9 months
15992737|NCT02943902|Biological|Pneumococcal conjugate vaccine (PCV10 ) 2+1|PCV10 2+1, 6&14 weeks & 9 months
15992738|NCT02943902|Biological|Pneumococcal conjugate vaccine (PCV13 ) 1+1, 6 weeks|PCV13 1+1, 6 weeks & 9 months
15992739|NCT02943902|Biological|Pneumococcal conjugate vaccine (PCV13 ) 1+1, 14 weeks|PCV13 1+1, 14 weeks & 9 months
15992740|NCT02943902|Biological|Pneumococcal conjugate vaccine (PCV13 ) 2+1|PCV13 2+1, 6&14 weeks & 9 months
15992741|NCT02943889|Biological|Mesenchymal stem cell transplantation|Bone marrow aspiration by clinical pathologist. Isolation, propagation and differentiation of stem cells will be done in stem cell center. After confirmation of the trans-differentiation into hepatocytes at the laboratory level, it will be infused into the portal vein under ultrasound guidance.
15992742|NCT02943876|Other|personalized depression risk information|The personalized depression risk information is determined by sex-specific risk prediction algorithms based on one's family history of depression, current health status, childhood traumatic experience and ongoing life stressors. The information is in the form of probability of having a major depressive episode in the next 4 years.
15992743|NCT02943863|Device|HFNC followed by conventional nasal cannula|
15992744|NCT02943863|Device|Conventional nasal cannula followed by HFNC|
15992745|NCT02943850|Biological|Stem cell (HPC) implantation|All patients will received unilateral lumbar spinal cord injections of CNS10-NPC-GDNF cells.
15992746|NCT02943850|Device|Stereotactic surgical device|A newly developed stereotactic frame is being evaluated as a part of this trial
15992747|NCT02943837|Procedure|Device: 22G FNA needle|
15992748|NCT02943837|Procedure|Device: 20G FNB needle|
15992749|NCT02943824|Other|Machine Learning Planning|The intervention being tested is a novel approach to planning LDR treatment plans using a machine learning computer algorithm.
15992750|NCT02943824|Other|Radiation Therapist Planning|The intervention being compared to the experimental arm is conventional manual planning by a human expert LDR brachytherapy planner.
15992751|NCT02943811|Device|UTERINE MANIPULATOR|Patients were operated laparoscopically with the aid or not of an intrauterine probe to manipulate the uterus
15992752|NCT02943798|Drug|etoposide plus carboplatin|etoposide is administered by venus with a dose of 100mg/m2 from day 1 to3, and carboplatin is administered by venus with a dose of AUC 5 on day 1 in a 21-day cycle.
15992753|NCT02943798|Drug|Paclitaxel plus carboplatin|Paclitaxel is administered by venus with a dose of 175 mg/m2 from day 1 and carboplatin is administered by venus with a dose of AUC 5 on day 1 in a 21-day cycle.
15992754|NCT02943785|Drug|Edoxaban-based Regimen|15 mg, 30 mg and 60 mg film coated tablet for oral use (with anti-platelet therapy pre-declared at randomization if prescribed)
15992755|NCT02943785|Drug|VKA-based Regimen|Dosed at International Normalized Ratio (INR) levels, which is a test of how long it takes for blood to clot. Standard of Care treatment in the country location (with anti-platelet therapy pre-declared at randomization if prescribed).
15992756|NCT02943772|Other|Local hypothermia|Cooled brick
15992757|NCT02943772|Other|Control|Control brick
15992758|NCT02943759|Drug|Neem leaf extract|A natural irrigant solution act as anti-inflammatory and anti bacterial
15992759|NCT02943759|Drug|Chlorhexidine gluconate|2%chlorhexidine gluconate , anti bacterial root canal irrigant solution
15992762|NCT02943733|Drug|TAS-102|Anti-metabolite agent, taken orally.
15992763|NCT02943733|Drug|Temozolomide|Oral chemotherapy drug.
15992764|NCT02943733|Drug|Filgrastim|Filgrastim provides growth factor support in multiple doses. It stimulates bone marrow to create neutrophils for patients undergoing chemotherapy.
15992765|NCT02943733|Drug|Pegfilgrastim|Pegfilgrastim provides growth factor support in a single dose. It stimulates bone marrow to create neutrophils for patients undergoing chemotherapy.
15992766|NCT02943720|Drug|AllerT|Bet v 1 contiguous overlapping peptides mixed with aluminium hydroxide solution
15992767|NCT02943720|Drug|placebo|placebo
15992768|NCT02943707|Procedure|Autologous bone marrow stem cells infusion|Autologous bone marrow stem cells are infused into proper hepatic artery
15992769|NCT02943707|Drug|drugs such as Ursodeoxycholic Acid tablets|Ursodeoxycholic Acid tablets(UDCA), each time 150 mg, three times a day orally
15992770|NCT02943694|Device|TaTME with CS-Compact (GelPoint pathway)|Standard TaTME with circular stapler (Short and straight, CS Compact), designed for extra-corporeal and endo-anal anastomosis procedures.
15992771|NCT02943681|Biological|Measles vaccine|
15992772|NCT02943668|Drug|Deferasirox|Given PO
15992773|NCT02943668|Other|Laboratory Biomarker Analysis|Correlative studies
15992774|NCT02943655|Drug|combined contraceptive pills (microcept)|oral combined contraceptive once daily
15992775|NCT02943655|Drug|medroxyprogesterone acetate (progest)|oral 5 mg medroxyprogesterone acetate daily
15992776|NCT02943655|Drug|mefenamic acid (ponstan forte)|oral 500 mg mefenamic acid three times per day
15992777|NCT02943642|Biological|A-dmDT390-bisFv(UCHT1)|anti-T cell immunotoxin (antibody targeting CD3 on T-cells tagged with diphtheria toxin without binding domain)
15992778|NCT02943642|Drug|Vorinostat|ZOLINZA is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous manifestations in patients with cutaneous T-cell lymphoma (CTCL) who have progressive, persistent or recurrent disease on or following two systemic therapies.
15992849|NCT02943109|Other|Low Touch|"Participants receives a visit from a patient navigator who helps to explain how to navigate the hospital system (active control)."
15992881|NCT02942771|Drug|0.15mg/kg TT301MW189|0.15 mg/kg IV twice daily on Days 1 through 5
15992779|NCT02943629|Device|Apneic oxygenation: Eight minute|A Pentax AWSTM video laryngoscope with attached P blade will be placed and then 10 l/minute flow of oxygen will be administered through the P blade (apneic oxygenation) for eight minutes, or less if SpO2 falls to ≤ 95%. The trachea will then be intubated and the ventilation of the lungs will commence using 100% oxygen until SpO2 ≥ 98%.
15992780|NCT02943629|Device|Without apneic oxygenation|A Pentax AWSTM video laryngoscope with attached P blade will be placed for eight minutes, or less if SpO2 falls to ≤ 95%. The trachea will then be intubated and the ventilation of the lungs will commence using 100% oxygen until SpO2 ≥ 98%.
15992781|NCT02943629|Device|Apneic oxygenation: five minutes|A Pentax AWSTM video laryngoscope with attached P blade will be placed and then 10 l/minute flow of oxygen will be administered through the P blade (apneic oxygenation) for five minutes, or less if SpO2 falls to ≤ 95%. The trachea will then be intubated and the ventilation of the lungs will commence using 100% oxygen until SpO2 ≥ 98%.
15992782|NCT02943616|Device|Absorb BVS|"Commercially approved Absorb GT1 BVS, herein referred to as Absorb.
~Scaffold diameters: 2.5, 3.0, and 3.5 mm
~Scaffold lengths: 8, 12, 18, 23 and 28 mm
~Absorb is a temporary scaffold that will fully resorb over time and is indicated for improving coronary luminal diameter in patients with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
15992783|NCT02943603|Drug|mFLOFOX6 + pembrolizumab|the combination of mFOLFOX6 + pembrolizumab is the single intervention even though the is dosed differently.
15992784|NCT02943590|Drug|Placebo|A pill taken once a day
15992785|NCT02943590|Drug|Atorvastatin|A pill taken once a day
15992786|NCT02943577|Drug|Rapastinel|Rapastinel pre-filled syringes for weekly IV injections.
15992787|NCT02943577|Drug|Placebo|Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
15992788|NCT02943564|Drug|Rapastinel|Rapastinel pre-filled syringes for weekly IV injections.
15992789|NCT02943564|Drug|Placebo|Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
15992790|NCT02943551|Other|Online Tutorial|For each group of practices, during the first month of intervention participation, study staff at Seattle Children's Research Institute will send each participating provider within a group/wedge, via email, a password to access the online tutorial. Participants will be asked to view the 40-minute tutorial at a time that is convenient for them but prior to the first webinar. Investigators will be able to track whether and how often participants access the online tutorial as a measure of engagement in the intervention. PROS will follow up, via email or phone, with providers who have not completed the tutorial within a three week timeframe.
15992791|NCT02943551|Other|Webinars|"The first webinar, focused on making appropriate antibiotic choices for bacterial ARTIs, will be held at the beginning of month 2 of intervention participation, and the second webinar, focused on recommended communication practices during visits for ARTIs, will be held at the beginning of month 3 of intervention participation. Due to webinar faculty time constraints, we will establish dates/times for the webinar prior to recruitment. Providers will be given information on webinar dates in both the randomization email, as well as include the dates in the study box letter.
~The webinars will be recorded to facilitate attendance for those who are unable to make the scheduled date/time. Included in the recording will be the presentation and any questions and answers from participants."
15992792|NCT02943551|Other|Booster Sessions|"An online link to the first booster video vignette will be sent to practice participants via email at the beginning of month 5 of intervention participation for each group/wedge. The link will lead to a website in which the provider will need to create a user name and password to access the booster videos. Two additional booster vignettes will be made available for viewing at the beginning of months 7 and 9 of intervention participation.
~For each of the three booster sessions, up to three reminders to complete viewing the video vignette will be sent over a 2-week period. The study team will be able to monitor whether participants access and complete the questions at the end of each vignette."
15992793|NCT02943551|Other|Feedback Reports|"During the intervention phase, providers will also receive 6 audit and feedback reports given by parents.
~The first report will have two parts:
~The first part will focus on the provider's overall antibiotic prescribing rates for all ARTIs (viral and bacterial) and rates of using second-line antibiotics for bacterial ARTIs.
~The second part will report the rates at which the provider uses the targeted communication practices as well as their average satisfaction scores."
15992794|NCT02943551|Other|Parent Survey|Throughout the study, parents at participating practice sites will be offered the opportunity to complete a DART Parent Survey after their child's visit.
15992795|NCT02943538|Device|Telemedicine|Monitoring and control is performed through telematics platform integrated management of chronic NOMHAD, configurated to respond the patients specific needs.
15992796|NCT02943538|Device|Telephone|A telephone control of their state and evolution will be made through the nursing staff of the unit.
15992797|NCT02943538|Other|Conventional care|Conventional care provided in the unit to patients with IBD -high moderate complexity.
15992798|NCT02943525|Procedure|vaginal packing|Packing vagina with a Boric acid soaked gauze at the end of surgery
15992799|NCT02943512|Other|Discharge day of procedure|Subjects will be discharged the day of the procedure if safe
15992800|NCT02943499|Behavioral|App/Training|This is a free smoking cessation smartphone app using the latest evidence-based smoking cessation methods and behavior change theory. The app allows users to set a quit date, financial goals, and reminders, track daily smoking habits with an easy-to-use calendar, see graphs tracking money saved and number of packs not smoked, receive health milestones and craving tips to stay motivated, connect with social networks to give milestone updates, create a video diary, and watch personalized video messages from loved ones
15992801|NCT02943499|Behavioral|App/Training|It is comprised of twenty-two modules of 10-15 minutes each, designed to teach mindfulness for smoking cessation using psychoeducation-based audio and videos, animations to reinforce key concepts, and in vivo exercises. In addition, 5 bonus modules become available upon completion of earlier modules; these may be accessed for additional practices to bolster other modules.
15992802|NCT02943499|Device|Smartphone|
15992803|NCT02943486|Other|dac-MSCs|Cell-free therapy
15992804|NCT02943486|Other|MSCs|Cell-based therapy
15992805|NCT02943486|Drug|Fitostimoline|Triticum vulgare
15992850|NCT02943109|Other|High Tech|Patient receives full-suite access to an inpatient patient portal with bi-directional communication enabled.
16008932|NCT02820597|Device|ClariFix device|
15992806|NCT02943473|Drug|Ibrutinib|"Ibrutinib is a type of drug called a kinase inhibitor. Kinases are proteins inside cells that help cells live and grow. Ibrutinib blocks a specific kinase protein in our bodies. This protein is thought to be very important in helping blood cancer cells live and grow. By blocking this kinase protein, ibrutinib stops cancer cells from growing."
15992807|NCT02943460|Drug|Cilofexor|Tablet(s) administered orally once daily with food
15992808|NCT02943460|Drug|Placebo to match cilofexor|Tablet(s) administered orally once daily with food
15992809|NCT02943447|Drug|Cilofexor|Tablet(s) administered orally once daily, with food
15992810|NCT02943447|Drug|Placebo to match cilofexor|Tablet(s) administered orally once daily, with food
15992811|NCT02943434|Other|Processed food|This is examining the effects of processed foods on diet-induced thermogenesis.
15992812|NCT02943421|Procedure|Transverse B-Lynch suture|
15992813|NCT02943408|Behavioral|person-centered mental health intervention|We anticipate that the PCMHI will be comprised of three, one-hour sessions offered over three to six weeks, scheduled at the participants' preference. Sessions will be one-on-one and the peer support specialist interventionist.
15992814|NCT02943408|Behavioral|health and wellness|The control condition will be an educational health and wellness intervention for stress related disorders that will match the experimental condition for time and attention. The control condition will be three, one hour, individual sessions covering the symptom cycle, managing stress, and identifying social supports.
15992815|NCT02943395|Other|E.Max CAD Laminate Veneers cemented with dual cure amine free adhesive resin cement|
15992816|NCT02943395|Other|E.Max CAD Laminate Veneers cemented with light cured adhesive resin cement|
15992817|NCT02943382|Other|Fingerprick autologous blood (FAB)|Pricking of cleaned finger using diabetic lancet and applying blood droplet to affected eye. Repeated with separate finger for other affected eye.
15992818|NCT02943369|Drug|Ticagrelor 180 mg loading dose|Ticagrelor 180 mg
15992819|NCT02943369|Drug|Cangrelor 30 mcg/kg bolus + 4 mcg/kg/min|Intravenous Cangrelor 30 mcg/kg bolus + 4 mcg/kg/min for 2 hours
15992820|NCT02943356|Drug|Tadalafil|Patients will be treated with Tadalafil for 8 weeks
15992821|NCT02943343|Other|No intervention|
15992822|NCT02943330|Other|Questionnaire|Questionnaires such as Hospital Anxiety and Depression Scale (HADS) and Montgomery Asberg Depression Rating Scale (MADRS), Short-form Health-related Quality of Life (SF-36), as well as psychiatric diagnostic interview with the Mini-International Neuropsychiatric Interview (MINI) and the Family Interview for Genetic Study (FIGS).
15992823|NCT02943317|Drug|Part A - VS-6063|Part A - Oral VS-6063 (defactinib) twice-daily (BID) continuously starting on Day 1 of Cycle 1.
15992824|NCT02943317|Drug|Part A - Avelumab|Part A - avelumab IV treatment in 28-day cycles (10 mg/kg over approximately 1 hour on Days 1 and 15).
15992825|NCT02943304|Other|Symptomatic pregnant women with positive RT-PCR ZIKV in serum or urine, or a positive serologic test specific for ZIKV|
15992826|NCT02943291|Behavioral|4x4 minutes high intensity interval training|Treadmill running/walking with 10 minutes warm-up at 60-70% of maximum heart rate, 4x4 minute intervals at 90-95% of maximum heart rate separated by 3-minutes active pauses at 60-70% of maximum heart rate, and 3 minutes cool-down.
15992827|NCT02943291|Behavioral|10x1 minute high intensity interval training|Treadmill running/walking with 10 minutes warm-up at 60-70% of maximum heart rate, ten 1-minute intervals at maximal intensity (that can be performed for one minute), separated by 1-minutes active pauses at 60-70% of maximum heart rate, and 3 minutes cool-down.
15992828|NCT02943278|Behavioral|Intensive Sleep Retraining|Participants in this group you will spend just over 1 day at our sleep lab, starting around their usual bedtime and ending the following day. Over a 20 hour period participants will complete a sleep retraining session, which involves an opportunity to fall asleep every 30 minutes; we will wake participants up after a few minutes if they fall asleep.
15992829|NCT02943278|Behavioral|Sleep Hygiene|Participants in this group will complete one session with a clinician focused on psychoeducation regarding sleep positive practices.
15992830|NCT02943265|Other|Care Coordination Strategies|Co-located Care coordinator will use EMR-driven registry to facilitate patient transitions between primary care and oncology care and enhance teamwork through coaching and technical assistance.
15992831|NCT02943252|Drug|Apatinib|apatinib 500 mg in tablet once daily
15992832|NCT02943252|Drug|S1|S-1 40-60mg bid, days 1-14 , every 3 weeks
15992833|NCT02943239|Drug|REGN1033|REGN1033
15992834|NCT02943239|Drug|REGN2477|REGN2477
15992835|NCT02943239|Other|Placebo|Placebo
15992836|NCT02943226|Device|Becton Dickinson Nexiva Diffusics System|Becton Dickinson Nexiva Diffusics System will be used to inject IV contrast and will be compared to a single hole catheter to see if it improves image quality in the main vessels in the abdomen and pelvis because of its novel design.
15992837|NCT02943226|Device|Standard intravenous catheter|Standard catheter with one hole at the tip will be compared to a novel 3 hole catheter to see which catheter provides the best image quality.
15992838|NCT02943213|Drug|Chlorpromazine Hydrochloride|Chlorpromazine Hydrochloride (25 mg Tablet) - Generic US Applicant holder is USL Pharma Inc.
15992839|NCT02943187|Behavioral|Cognitive training|A clinician will deliver three 90-minute cognitive training sessions per week for 14 weeks. There are 16 different categories of leveled training procedures sequenced in intensity and difficulty for a total of 530 training tasks.
15992840|NCT02943187|Dietary Supplement|Nutrition|Participants will be given dietary recommendations and nutritional supplements to optimize cognition.
15992841|NCT02943174|Behavioral|MIND programme for cancer patients|Psychotherapeutic programme based on Acceptance, Mindfulness and Compassion for cancer patients Other: Cancer Treatment as Usual
15992842|NCT02943174|Other|Treatment as Usual (TAU)|Standard personalized treatment of cancer
15992843|NCT02943161|Dietary Supplement|L-Citrulline|The purpose of this study is to see if citrulline supplementation will restore NO levels and lung function in subjects with asthma.
15992844|NCT02943148|Other|Davey score for striae gravidarum|
15992845|NCT02943135|Drug|lidocaine in-situ gel|lidocaine in-situ gel
15992846|NCT02943135|Drug|placebo in-situ gel|placebo in-situ gel
15992847|NCT02943122|Device|Ambulatory blood pressure monitor|
15992848|NCT02943109|Other|High Touch|"Participants receives an in person visit from an technology navigator who helps to explain the technology to the patient."
15992851|NCT02943109|Other|Low Tech|Patient receives a limited access version of the inpatient patient portal with bi-directional communication disabled.
15992852|NCT02943096|Dietary Supplement|CocoaVia|Flavanols represent a specific group of plant derived nutrients that are found in cocoa beans, grapes, tea, berries and various other fruits and vegetables. The specific flavanols investigated in this study come from cocoa.
15992853|NCT02943096|Other|Placebo|"The placebo looks like the other intervention pills, but does not contain any flavanols (it is sometimes called a sugar pill)."
15992854|NCT02943083|Behavioral|Relaxation Exercise|Groups receiving the intervention will be asked to engage in the relaxation protocol every day. Participants will be asked to continue practicing the relaxation protocol for the remainder of their pregnancy. Participants will be instructed to listen to the 7 minute guided muscle relaxation tape and engage in the 3 minute abdominal touch routine in the presence of the scent stick. Participants will be provided with a scent stick of their selected scent to take home. For the duration of the study, participants will be loaned standard headphones and an iPod Touch that contains only the guided progressive muscle relaxation audio recording to facilitate this at-home protocol.
15992855|NCT02943070|Device|Rezum System|"The Rezūm System treats patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate wet thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death. The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure."
15992856|NCT02943057|Drug|2% guttae ganciclovir|2% guttae ganciclovir 5 times a day for 6 weeks
15992857|NCT02943044|Device|No intervention, this is an observational study|Non interventional, non-invasive measurements of tissue samples suspected of squamous cell carcinoma using an optical probe.
15992858|NCT02943031|Other|Individualized Precision Therapy Programs|After bile duct tumor samples were collected, whole genome sequencing, drug screening ( including Mini-PDX and PDX) will conduct. Suitable drugs will be decided according to the different genomics classification.OS and PFS will be recorded.
15992859|NCT02943018|Other|anovaginal distance variation|Kappa calculation
15992860|NCT02943005|Procedure|Rotator cuff repair|
15992861|NCT02942992|Behavioral|Resistance exercise|resistance exercise
15992862|NCT02942966|Device|Tack Endovascular System|Repair of post-PTA dissections using the Intact Vascular Tack Endovascular System.
15992863|NCT02942953|Device|Diaphragmatic Pacer|The surgical procedure of DP implantation consists in placing four intramuscular electrodes, using a conventional abdominal laparoscopy with four ports. It consists in locating the optimum point for electrode insertion. The process involves mapping between 30 and 50 different points in each hemidiaphragm by applying an electric stimulus of 2-24 mA at 100 µsec pulse widths11. It results in both qualitative and quantitative assessment of diaphragmatic movement. Site of main electrode is identified as the location of each hemidiaphragm's change of maximum pressure and site of secondary electrode as replica of main site. Once the sites are identified intramuscular electrode placement phase is initiated. Finally the electrodes are tunneled out to the corresponding percutaneous exit site.
15992864|NCT02942940|Device|mobile app|The mobile app follow-up group will have no planned in-person follow-up, however these visits will be replaced with surgical site examination via submitted photos, Visual Analogue Scale (VAS), and Quality of Recovery - 9 questionnaire (QoR-9) and limb specific recovery monitoring. All information is submitted with the mobile app (QoC Health Inc, Toronto).
15992865|NCT02942940|Other|conventional in-person|Patients in the conventional follow-up group will have a planned clinic follow-up at 2 and 6 weeks post-operatively, which is the schedule currently used by our surgeons. At these scheduled follow-up visits, patients will be asked to complete the VAS to assess pain and the QoR-9 in addition to recovery questions about their operated extremity.
15992866|NCT02942927|Other|Medication reduction|Systematic approach to reduction in polypharmacy.
15992867|NCT02942914|Drug|LY3209590|Administered SC
15992868|NCT02942914|Drug|Placebo|Administered SC
15992869|NCT02942914|Drug|Insulin Glargine|Administered SC
15992870|NCT02942901|Procedure|PET-CT|
15992871|NCT02942888|Dietary Supplement|Nicotinamide riboside|Oral administration of Niagen ramp up 250mg to 1g/day as tolerated
15992872|NCT02942888|Dietary Supplement|Sugar Pill|This is a placebo compounded by ChromaDex, Inc.
15992873|NCT02942875|Other|mirror therapy|"During MT, subjects will sit in front of a table on which a mirror will be placed vertically in the space ipsilateral to the paretic upper limb with its reflective surface facing the unaffected upper limb. The subjects are required to look at the mirror to observe the reflective image of the unaffected arm from shoulder to the hand, while it is performing certain designated movements. At the same time, the affected arm will be required to follow the unaffected arm to practice the same movements.
~The upper limbs movements during the 30-min MT session are open and close of grasp; wrist flexion and extension; forearm supination and pronation; elbow flexion and extension; shoulder flexion and extension. A total of 120 repetitions for each action will be practiced."
15992874|NCT02942875|Other|control therapy|Control group subjects undergo the same bilateral upper limbs exercise protocol without mirror
15992875|NCT02942862|Drug|Orcein staining|Prognostic value of venous emboli detected by orcein staining
15992876|NCT02942849|Drug|r-hFSH|As per standard clinical practice
15992877|NCT02942836|Device|non-intrusive respiration monitor|Equivalence of CareTaker's respiration rate detection capability to that of predicate device
15992878|NCT02942823|Other|"The serious game KOP"|The serious game transfers knowledge about nutrition (food pyramid, energy density of foods, which foods contribute to satiety and which not, energy in liquids, self-reflexive diagnostic tool to analyze daily food intake), physical activity (a motion-control to navigate through the game is partly used, relationship between energy expenditure and energy intake) and psychological aspects (relaxation-exercises, what is stress, stress-coping strategies).
15992879|NCT02942810|Drug|WCK 5222|IV infusion over a period of 60 minutes
15992880|NCT02942771|Drug|0.075mg/kg TT301/MW189|0.075 mg/kg IV twice daily on Days 1 through 5
15992882|NCT02942771|Drug|0.25mg/kg TT301/MW189|0.25 mg/kg IV twice daily on Days 1 through 5
15992883|NCT02942771|Drug|0.30mg/kg TT301/MW189|0.30 mg/kg IV twice daily on Days 1 through 5
15992884|NCT02942771|Drug|Placebo|0.9% sodium chloride
15992885|NCT02942758|Drug|low-dose Azacitidine|Azacitidine 75 mg/d s.c. for 7 days, repeated 28-day treatment cycle
15992886|NCT02942758|Drug|Pioglitazone|Pioglitazone 45 mg p.o. continuously from day 1
15992887|NCT02942758|Drug|ATRA|ATRA *45 mg/m² p.o. from day 1 to 28, 15 mg/m² from day 29 continuously; *this regimen will be chosen for the first dose to be evaluated.
15992888|NCT02942758|Drug|standard-dose AZA|Azacitidine 75 mg/m²/d s.c. for 7 days, repeated 28-day treatment cycle
15992889|NCT02942745|Behavioral|Betel Nut Cessation Social Support|The cessation sessions will be led by trained facilitators over 22-day period. Session 1 (Day 1) includes a discussion of health risks associated with betel nut chewing, and introduction to self-monitoring and triggers logs. Session 2 (Day 8) includes a review of their logs, and discussions of lifestyle changes to assist cessation of betel nut chewing. Session 3 (Day 15) will be the quit day for chewers. Coping mechanisms and plans to maximize social support will be discussed. Session 4 (Day 18) will focus on quitting experiences. Facilitators will also review the negative health effects when wanting to chew again. Discussion on quitting experiences will continue in Session 5 (Day 22). Facilitators will also address those who have experienced relapse, and how to manage relapse.
15992890|NCT02942745|Behavioral|Betel Nut Cessation Booklet|Participants will receive minimal intervention via a single booklet that contains all the information offered in the experimental group, minus the social support sessions. The participants will meet with study staff individually at a designated office in Guam or Saipan to receive the betel nut cessation booklet, complete three assessments (baseline, 22 days, 6 months), and provide saliva samples.
15992891|NCT02942732|Dietary Supplement|cholecalciferol (Euro-Pharm International, Canada)|All assigned patients received a supplement of 10,000 IU cholecalciferol (Euro-Pharm International, Canada) to be taken three times per week. The treatment was led for a period of 6 months.
15992892|NCT02942706|Drug|Cetuximab|anti-EGFR monoclonal antibody
15992893|NCT02942706|Drug|mFOLFOX6|Oxaliplatin+LV5FU2
15992894|NCT02942706|Drug|FOLFIRI|Irinotecan+LV5FU2
15992895|NCT02942693|Drug|Apatinib|Apatinib will be used as induction therapy in experimental arm.
15992896|NCT02942693|Radiation|Particle Therapy|Same total dose and fractionation will be used in both arms.
15992897|NCT02942680|Drug|acetylsalicylic acid started for 24 hours before surgery|
15992898|NCT02942680|Drug|acetylsalicylic acid stayed for 5 days before surgery|
15992899|NCT02942654|Drug|LY900014|Administered subcutaneously (SC)
15992900|NCT02942654|Drug|Insulin Lispro|Administered SC
15992901|NCT02942641|Procedure|Indwelling urethral catheterization (Foley)|"Hospitalized patients who developed first-time AUR were randomly divided into two groups depending on the type of assigned intervention: CIC and indwelling urethral catheter groups.
~Patients in this group received indwelling urethral catheter as the intervention."
15992902|NCT02942641|Procedure|Clean intermittent catheterization (CIC)|"Hospitalized patients who developed first-time AUR were randomly divided into two groups depending on the type of assigned intervention: CIC and indwelling urethral catheter groups.
~Patients in this group received CIC as the intervention."
15992903|NCT02942641|Device|Foley|
15992904|NCT02942628|Other|Vegetarian diet followed by meat diet or vice versa|Half the patients will follow either a vegetarian diet for 6 weeks and the other half will adhere to or a meat-based diet for six weekd. This is followed by a 4 week period where patients eat their usual diet. Thereafter patients initially randomized to a vegetarian diet will follow a meat-based diet for six weeks while the patients initially randomized to meat will follow a vegetarian diet for six weeks.
15992905|NCT02942615|Other|limit heart dose|limit heart dose: Dmean≤6Gy,V30≤20%,V10≤50%
15992906|NCT02942602|Drug|Atorvastatin 20 mg|The patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy will be randomized into 5 groups.
15992907|NCT02942602|Drug|Cholestyramine 8 g|The patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy will be randomized into 5 groups.
15992908|NCT02942602|Drug|Omega-3 2g|The patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy will be randomized into 5 groups.
15992909|NCT02942602|Drug|Concurrent with Atorvastatin 5 mg + Ezetimibe 10 mg|The patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy will be randomized into 5 groups.
15992910|NCT02942602|Behavioral|Lifestyle modification|The patients who meet the 2013 American College of Cardiology/American Heart Association criteria for receiving lipid-lowering therapy will be randomized into 5 groups.
15992911|NCT02942589|Other|Meal portion size|
15992912|NCT02942576|Drug|Edoxaban|Edoxaban 60 mg once-daily or 30 mg once-daily in selected subjects.
15992913|NCT02942576|Drug|VKA-Based Regimen|Dosed at International Normalised Ratio (INR) levels, which is a test of how long it takes for blood to clot. Standard of Care treatment in Canada, Italy, Poland, Hungary, Czech Republic, United Kingdom (UK), Taiwan and Korea.
15992914|NCT02942576|Drug|VKA-Based Regimen|Dosed at INR levels. Standard of Care treatment in Germany, Belgium, and the Netherlands.
15992915|NCT02942576|Drug|VKA-Based Regimen|Dosed at INR levels. Standard of Care treatment in France.
15992916|NCT02942576|Drug|VKA-Based Regimen|Dosed at INR levels. Standard of Care treatment in Spain.
15992917|NCT02942563|Drug|FOLFOXIRI|"Irinotecan* 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle for 4-6 cycles,
~Chemoradiation for patients who are not suitable to surgery:
~Pelvic radiotherapy(45Grey/25Fraction and 5.4Grey/3Fraction boost to the tumor bed) combined with capecitabine(625mg/m², bid po, d1-5, qw), and additional four cycles of modified FOLFOX6 (mFOLFOX6) or Oxaliplatin 135mg/m²plus Capecitabine 1.0/m² bid po(XELOX) of each 3 weeks cycle for 2 cycles chemotherapy before TME.
~All patients will receive 6-8 cycles of mFOLFOX6 or 4-5 cycles XELOX as adjuvant chemotherapy after TME."
15992918|NCT02942550|Drug|Methylnaltrexone bromide (Relistor®).|
15992919|NCT02942550|Drug|Sodium Chloride 9mg/mL|
15992920|NCT02942537|Device|Microwave treatment|Percutaneous or vaginal application of microwave antenna with microwave treatment of fibroma
15992921|NCT02942537|Procedure|uterine artery embolization|Percutaneous applicaiton of a catheter into the femoral artery and embolization of uterine artery or branches thereof
15992922|NCT02942524|Other|Communication Intervention|Complete TEPID
15992923|NCT02942524|Other|Questionnaire Administration|Ancillary studies
15992924|NCT02942524|Other|Survey Administration|Ancillary studies
15992925|NCT02942498|Drug|Vitamin C 10mg/Kg Vitamin E 10 mg/Kg|
15992926|NCT02942498|Drug|Placebo|Placebo
15992927|NCT02942485|Drug|Metronidazole|P/r suppositories
15992928|NCT02942485|Drug|Tinidazole|P/o tablets
15992929|NCT02942459|Other|Music therapy|25 Weekly Hours of Music Therapy by an Educated Music Therapist
15992930|NCT02942459|Other|Music Listening|25 weekly Hours of Being Together with an unknown Care Staff Member
15992931|NCT02942446|Device|Investigative Headgear with CPAP mask|Investigative Headgear with CPAP mask
15992932|NCT02942433|Behavioral|Behavior Change Communication|9-month weekly episode behavior change radio drama with interactive voice response (IVR)/short message service (SMS) listener engagement
15992933|NCT02942433|Behavioral|Community Mobilization|Listening and discussions groups, 2 male and 2 female groups per study site meet weekly for 39 weeks and will receive training on gender equity, intimate partner violence (IPV), life skills, community mobilization, non-violent conflict resolution for listening and discussion group (LDG) facilitators to support knowledge and skill set acquisition of LDG members. There will be a joint couple's session every month to foster mutual learning and understanding in addition to community mobilization incentives led by LDGs and encouragement of family members of LGD members to listen to the radio and attend LDG sessions once every 3 months. Participants will also receive awareness raising and street theater to engage families and community members.
15992934|NCT02942433|Behavioral|Advocacy|Training and 6-month follow up of religious/community leaders and religious leaders support community mobilization activity of local listening and discussion group (LGD).
15992935|NCT02942420|Drug|Bucillamine|Thiol donor which results in a cysteine-bucillamine complex for removing excess cysteine from the urine
15992936|NCT02942407|Drug|apixaban|oral anticoagulant
15992937|NCT02942407|Drug|warfarin|oral anticoagulant
15992938|NCT02942394|Device|sinus-Obliquus Stent System|
15992939|NCT02942381|Drug|Hydroxychloroquine Sulfate|200mg Bid (eGFR>60 ml/min/1.73m2 ), 100mg Tid(eGFR45-59 ml/min/1.73m2 ), 100mg Bid(eGFR 30-44 ml/min/1.73m2 )
15992940|NCT02942381|Drug|Placebo|
15992941|NCT02942368|Device|tDCS|Transcranial direct current stimulation with placement of the anode over the F3 region of the scalp and the cathode over the right supraorbital region.
15992942|NCT02942355|Drug|anastrozole|Anastrozole by mouth daily
15992943|NCT02942355|Drug|Palbociclib|Palbociclib by mouth daily days 1-21 every 28 days
15992944|NCT02942342|Procedure|Computed Tomography (CT) Scan|CT Scans will be used as a diagnostic tool for asymptomatic CAD.
15992945|NCT02942329|Drug|apatinib|Apatinib was administered 250mg or 375mg orally daily. For gastric cancer patients, the dose would be 250mg or 375mg daily. For hepatocellular carcinoma patients, the dose would be 250mg daily.
15992946|NCT02942329|Drug|SHR-1210|SHR-1210 was administered 200mg (3mg/kg for underweight patients) iv every 2 weeks.
15992947|NCT02942316|Device|Pupil dilation reflex measurement|"Pupillometry (PDR) at four standardized times perioperatively
~after induction, before opioid administration
~after opioid administration, steady state
~surgical incision
~end of procedure"
15992948|NCT02942303|Drug|Dysport|
15992949|NCT02942303|Procedure|lateral orbicularis injection|
15992950|NCT02942303|Procedure|Lateral orbicularis + corrugator injection|
15992951|NCT02942290|Drug|Azacitidine|Powder for injection; taken subcutaneously (SC) or intravenous (IV); Administered on Days 1-7 of 28 days cycle or Days 1-5 of Week 1 & Days 1-2 of Week 2 of 28 day cycle.
15992952|NCT02942290|Drug|Venetoclax|Oral; Tablet
15992953|NCT02942277|Biological|Pfs25M-EPA|The PpPfs25M and EcEPA lots, both manufactured at Walter Reed Bioproduction facility (Silver Spring, Maryland) in cGMP compliance, were used to manufacture the conjugate. PpPfs25M is a Pichia- expressed recombinant Pfs25 with a molecular mass of 18,713 Daltons.The Pfs25M- EPA was formulated as conjugated Pfs25M in 4 mM PBS to a 2X dilution of the high dose (188 (Micro)g/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and will be provided as a single use vial.
15992954|NCT02942277|Biological|Pfs230D1M-EPA|The Pfs230D1M-EPA was formulated as conjugated Pfs230D1M in 4 mM PBS to a 2X dilution of the high dose (160 (Micro)g/ml in 0.5 ml volume) in cGMP compliance at Walter Reed Bio-production facility in April 2016 and will be provided as a single use vial.
15992955|NCT02942277|Other|AS01|AS01B adjuvant will also be provided as a single use vial by GSK, 100 microgram/mL MPL and 100microgram/mL QS21 in a liposomal formulation in a volume of 0.625 mL.
15992956|NCT02942277|Biological|Engerix-B|ENGERIX-B (hepatitis B vaccine; recombinant): is a sterile suspension of noninfectious hepatitis B virus surface antigen (HBsAg) for intramuscular administration. It contains purified HBsAg obtained by culturing genetically engineered Saccharomyces cerevisiae cells, which carry the surface antigen gene of the hepatitis B virus. Each 1-mL adult dose contains 20 g of HBsAg adsorbed on 0.5 mg aluminum as aluminum hydroxide. FDA approved for persons 20 years of age and older for a series of 3 doses on a 0-, 1-, 6-month schedule.
15992957|NCT02942277|Biological|Menactra|Menactra is FDA approved for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 (but does not protect against serotype B) for use in individuals 9 months through 55 years of age
15992958|NCT02942277|Other|Normal Saline|Sterile isotonic (0.9%) normal saline will be commercially procured in the US and shipped to Mali at ambient temperature. Normal saline will be administered in a 0.5 mL dose as an intramuscular injection. Normal saline will also be used for diluting Pfs25M-EPA and Pfs230D1M-EPA prior to formulation with AS01B for the lower dose groups in Bamako, Mali.
15992959|NCT02942277|Drug|Coartem|Artemether/lumefantrine (Coartem(R)) is a licensed antimalarial in the US and Mali for treatment of uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Subjects who may have any contraindications to the use of these drugs will be excluded at screening. Coartem will be dosed with food and administered over 3 days for a total of 6 doses, as per package insert and standard adult dosing
15992988|NCT02942082|Other|glycrin|glycrin will be applied on tooth surface before and/or after bleaching
15992960|NCT02942264|Drug|Zotiraciclib (TG02)|"Phase I: Two treatment arms and several dose levels are planned; In the maximum tolerated dose (MTD) finding part, Temozolomide (TMZ) with two alternate schedules (dose dense (dd) and metronomic (mn) in combination with Zotiraciclib (TG02) will be administered;
~--A cohort extension of both arms will be performed at each MTD and the treatment arm with a better progression free survival at 4 months (PFS4) will be selected for the combination treatment arm for Phase II; Patients will be randomized between two competing treatment arms: (winner of dd vs mn) TMZ + Zotiraciclib (TG02) versus dd/mn TMZ alone using a Bayesian clinical trial design. The dosage for the combination arm will be derived from the MTD determined in the Phase I component of the study."
15992961|NCT02942264|Drug|Temozolomide (TMZ)|"Phase I: In the maximum tolerated dose (MTD) finding part, Temozolomide (TMZ) with two alternate schedules (dose dense (dd) and metronomic (mn) in combination with Zotiraciclib (TG02) will be administered; A cohort extension of both arms will be performed at each MTD and the treatment arm with a better progression free survival at 4 months (PFS4) will be selected for the combination treatment arm for Phase II; Patients will be randomized between two competing treatment arms: (winner of dd vs mn) TMZ + Zotiraciclib (TG02) versus dd/mn TMZ alone using a Bayesian clinical trial design."
15992962|NCT02942251|Other|Clinical features and medication|This group will be suggested to take optimize treatment according to Chinese treatment guidelines.
15992963|NCT02942251|Other|Psycho-social|This group will be suggested to add on psychotherapy on medical treatment.
15992964|NCT02942251|Other|immunology|This group will be suggested to add on Omega-3 polyunsaturated fatty acid(PUFAs) on medical treatment.
15992965|NCT02942251|Other|Laboratory abnormality|This group will be suggested to more safety antidepressants.
15992966|NCT02942251|Other|Comorbidity|This group will be suggested to treat their comorbidities as well as treat MDD.
15992967|NCT02942251|Other|Treatment as usual|Patients will accept routine treatments based on psychiatrist experience, not based on the relapse predict model.
15992968|NCT02942238|Procedure|CME|"the group underwent laparoscopic right hemicolectomy with CME. In CME group, in addition to D2 dissection, the whole mesocolon, from ascending colon to right half transverse colon, as well as the central lymph nodes should be entirely removed.
~Intervention: Procedure: Complete mesocolic excision (CME)"
15992969|NCT02942238|Procedure|D3|"the group underwent laparoscopic right hemicolectomy with D3 lymph node dissection. In D3 group, the mesocolon should be removed and the dissection involves the paracolon and intermediate lymph nodes,including No.6 lymph node, which along the feeding vessels.
~Intervention: Procedure: D3 radical operation"
15992970|NCT02942212|Behavioral|Questionnaire|Participants complete a computerized questionnaire to assess demographics and smoking history.
15992971|NCT02942212|Behavioral|In-Depth Interviews|Participants take part in individual in-depth interviews discussing smoking history, attempts to quit, and suggestions for smoking cessation program. The interview should last 30-45 minutes and is audio-recorded.
15992972|NCT02942212|Other|Breath Test|Participants complete a breath test to assess the amount of cigarette smoke inhaled at baseline, weekly during study, and at 3 month follow up.
15992973|NCT02942212|Drug|Nicotine Patches|Participants receive a 6-week supply of nicotine patches and instructions on how to use them. Patch therapy for participants who smoke >10 cigarettes/day consists of 4 weeks of 21 mg patches, 1 week of 14 mg patches, and 1 week of 7 mg patches. Patch therapy for participants who smoke 5-10 cigarettes/day consists of 4 weeks of 14 mg patches and 2 weeks of 7 mg patches.
15992974|NCT02942212|Behavioral|Advice plus Phone Counseling|Participants receive brief advice to quit smoking, as well as phone counseling for support in quitting smoking (5 sessions over the course of 6 weeks) with a counselor at the Texas Quitline.
15992975|NCT02942212|Behavioral|Advice plus Counseling Sessions|Participants receive brief advice to quit smoking, as well as 5 individual, in-person smoking cessation treatment counseling sessions.
15992976|NCT02942212|Behavioral|Self Assessment Questionnaires|Participants complete self assessment questionnaires the week before quitting smoking, the day that they quit, and 1, 2, and 4 weeks after quitting, and at 3 month follow up.
15992977|NCT02942199|Other|MySafeRx|The MySafeRx platform is a combination of several key components, including daily videoconferencing check-ins with motivational interviewing-based recovery coaching, text-messaging reminders, secure storage of buprenorphine medication within a secure electronic pill dispenser (i.e., MedicaSafe 3000), and a standardized protocol for supervising self-administration of medication via videoconferencing.
15992978|NCT02942173|Biological|CD45RA-depleted peripheral blood mononuclear cells|Infusion of escalating doses of CD45RA-depleted donor-derived allogeneic peripheral blood mononuclear cells
15992979|NCT02942160|Biological|Collagenase Clostridium Histolyticum|
15992980|NCT02942147|Device|TENS|Group 2 patients were administered TENS therapy 30 minutes a day for 15 days at the outpatient physiotherapy unit of the Physiotherapy and Rehabilitation Department. The TENS therapy was applied in the form of conventional TENS subtype with 80-100 Hz frequency by placing four electrodes on the region where the pain was most intense.
15992981|NCT02942147|Procedure|Conventional or Pulse Radiofrequency|In the radiofrequency method applied to Group 1 and Group 3 patients, the targeted facet joints were marked while the fluoroscope was in antero-posterior position. During this marking, the fluoroscope was directed towards cephal or caudal so that at whatever level the median ramus block was to be involved the endplate of that vertebra would become a straight line. The connection point of the superior articular protrusion was marked on the fluoroscope using the transverse process and the intervention was applied with a 22G, 10-cm radiofrequency cannula with 0.5 cm active tip in a way that bone contact was established through the tunneled vision technique. The intervention was completed after the radiofrequency procedure was applied at four levels.
15992982|NCT02942121|Other|LifeScience Technologies application|Application for mobile devices. The app enables users to review educational videos about a surgery and recovery from a surgery from home. It also enables the user to track different metrics specific to the user's health.
15992983|NCT02942108|Procedure|piezo surgery|
15992984|NCT02942108|Procedure|conventional surgery|
15992985|NCT02942095|Drug|Ixazomib|"Dose Escalation Phase Starting Dose: Ixazomib 3.0 mg on Days 1, 8, and 15 of a 28-day cycle.
~Dose Expansion Phase: Maximum tolerated dose from Dose Escalation Phase"
15992986|NCT02942095|Drug|Erlotinib|Dose Escalation and Dose Expansion Phase: Erlotinib 150 mg by mouth on Days 1 - 28 of a 29 day cycle.
15992987|NCT02942082|Other|ACP oral care gel|a desensitizing agent will be applied on tooth before and/or after bleaching
15992989|NCT02942069|Behavioral|Blood glucose measured using CGM during standardized physical activity|Standardized exercise on bicycle at 70% of the participants work capacity for ½ hour.
15992990|NCT02942056|Drug|Cinnamon|Cinnamon tablets to treat type 2 DM
15992991|NCT02942056|Drug|placebo|placebo
15992992|NCT02942043|Drug|Bevacizumab|"Group A (low dose group) Intrapleural injection of bevacizumab 2.5mg/kg/times, d1, d8; 21 days for a course of treatment. Subjects will received two courses of treatment if there is no termination of treatment listed in the standard.
~Group B (medium dose group) Intrapleural injection of bevacizumab 5mg/kg/times, d1, d8; 21 days for a course of treatment. Subjects will received two courses of treatment if there is no termination of treatment listed in the standard.
~Group C (high dose group) Intrapleural injection of bevacizumab 7.5mg/kg/times, d1, d8; 21 days for a course of treatment. Subjects will received two courses of treatment if there is no termination of treatment listed in the standard."
15992993|NCT02942030|Other|Computerized assesment battery|All participants will do a computerized assessment battery to identify specific attentional profile
15992994|NCT02942017|Drug|Placebo|Intravenous infusion of matching placebo for SAGE-547.
15992995|NCT02942017|Drug|SAGE-547 90 μg/kg/h|Intravenous infusion of SAGE-547
15992996|NCT02942004|Drug|Placebo|Intravenous infusion of matching placebo for either SAGE-547 60 μg/kg/h or 90 μg/kg/h.
15992997|NCT02942004|Drug|SAGE-547 60 μg/kg/h|Intravenous infusion of SAGE-547.
15992998|NCT02942004|Drug|SAGE-547 90 μg/kg/h|Intravenous infusion of SAGE-547.
15992999|NCT02941991|Biological|hESC-RPE|sub-retinal injection
15993000|NCT02941978|Behavioral|Motivational interview|Patients assigned to the intervention group receive additional medical consultation aiming to boost optimal uptake of the anticoagulation regimen prescribed. Initially (i.e., at hospital discharge), this includes a physician-patient interactive session and provision of an educational leaflet. The leaflet is designed in a culturally and linguistically conceivable template in Greek language. It uses simple terms together with both written and pictorial materials. Patients in the intervention group will also undergo short telephonic sessions at 1 week, 2 months, 6 months and 12 months following hospital discharge
15993001|NCT02941978|Behavioral|Control|Patients assigned to the control group receive usual treatment, corresponding to standard practice and management of hospitalized patients with AF. For both patient-groups, the choice of OAC agent and any other background therapy is left to the discretion of the treating physician.
15993002|NCT02941965|Procedure|ICSI without PGS|Selection of embryos are based on morphology criteria on the 5th day of ICSI.
15993003|NCT02941965|Procedure|ICSI with PGS|PGS will be applied to selected embryos on the 5th day of ICSI.
15993004|NCT02941952|Device|Cardiac output and stroke ejection volume monitoring with both ClearSight® and PICCO® in major abdominal surgery.|
15993005|NCT02941939|Other|Hyperbaric chamber|
15993006|NCT02941939|Other|Ambient pressure|
15993011|NCT02941913|Drug|palonosetron|receive a fix dose of 75 μg of palonosetron (group I - GI) and another forty patients will receive a bodyweight-adjusted dose of 1mcg/kg of palonosetron (group II - GII).
15993012|NCT02941900|Genetic|MC1R genotyping|
15993013|NCT02941900|Behavioral|MC1R Testing Website|The website includes three educational modules about genetic testing with corresponding knowledge questions.
15993014|NCT02941900|Behavioral|Baseline Survey|
15993015|NCT02941887|Behavioral|Behavior Analysis|One examiner observed global behavior of patients during a dental care session, guided by a behavioral scale.
15993016|NCT02941874|Other|Blood sample collection during an OGTT to assess IRAP blood concentration|Blood sample collection during an OGTT to assess IRAP blood concentration. Blood samples will be collected every 15 minutes during 3 hours
15993017|NCT02941861|Other|Recurrence Rate of HCC after surgery|Recurrence Rate of HCC after surgery
15993018|NCT02941861|Other|Recurrence Rate of CCA after surgery|Recurrence Rate of CCA after surgery
15993019|NCT02941848|Drug|HGP0816|
15993020|NCT02941848|Drug|HGP1404|
15993021|NCT02941848|Drug|HCP1306|
15993022|NCT02941835|Radiation|pre-operative irradiation|pre-operative whole breast irradiation of 21 fx of 2.2Gy and boost of 2.66Gy
15993023|NCT02941822|Drug|Ambroxol|Details outlines in the intervention description.
15993024|NCT02941809|Behavioral|Open-Label Placebo (OLP)|We are designating this as a behavioral intervention for two reasons: (1) the placebo pill is physiologically inert and is not classified under FDA regulations; and (2) other studies have demonstrated that the efficacy of the placebo pill is strongly dependent on the participants' anticipation of an effect. We are presenting the pill's efficacy in an open and transparent way to the participants, but using a positive frame. We feel that this qualifies the placebo pill use as a behavioral intervention, in the same general category as exercise or relaxation.
15993025|NCT02941796|Drug|HCP1105|
15993026|NCT02941796|Drug|HCP0918|
15993027|NCT02941796|Drug|HCP0816|
15993028|NCT02941783|Drug|Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)|Treatment parameters following the physician's decision based on the summary of product characteristics.
15993029|NCT02941770|Behavioral|Physical activity behavior change|Physical activity consultation will consist in a patient-centered, one-to-one session based on the transtheoretical model and will use motivational interview in order to strengthen individual's intrinsic motivation to achieve a positive PA behavior change. In these sessions the following topics will be explored: (i) explore and resolve ambivalence; (ii) identify difficulties/barriers, and benefits of behavior change; (iii) find their own means and their own solutions for step over the identified barriers; (iv) enhancement of autonomy and self-efficacy.
15993074|NCT02941510|Drug|Budesonide|Budesonide is FDA approved for the treatment of asthma and Chronic Obstructive Pulmonary Disease (COPD). It works by reducing lung inflammation to increase oxygen uptake by the body. The researchers are examining if this medication can prevent altitude sickness.
15993484|NCT02938494|Drug|Vehicle Cream|Cream
15993030|NCT02941770|Other|Exercise|Experimental group II will participate accordingly with their availability in two exercise sessions per week (≈60 min/session) directed by one exercise physiologist. The ability to exercise will be assessed in order to customize the exercise plan. All the sessions will include: 10 minutes of warm-up, 5 minutes of agility exercises, 15 minutes of resistance training (including the major upper and lower muscles, 12-15 sets of 15 repetitions), 20 minutes of aerobic exercise, and 10 minutes of cool-down (50-80% heart rate reserve - Polar Vantage NV, Polar Electro Oy, Kempele, Finland). All the participants will have to attend at least 80% of the scheduled sessions.
15993031|NCT02941757|Behavioral|Mediterranean diet Intervention|"Educational materials (online learning) will be provided via the study website; group educational sessions and written materials (brochure with Mediterranean Diet recommendations, shopping list recommendations and sample recipes, specific Mediterranean Diet Pyramid; videos; educational sessions; in-person chef-led, Mediterranean cooking demonstrations.
~Peer-education and support
~Discounted food access: The investigators have partnered with Kroger supermarkets, a large national chain with numerous stores in the Indianapolis area, to provide discounted access to key Mediterranean foods for both participating firefighters and their families.
~Email or text message encouragement and reminders during the intervention."
15993032|NCT02941744|Drug|nivolumab|low fixed dose ipilimumab in combination with nivolumab
15993033|NCT02941744|Drug|ipilimumab|low fixed dose ipilimumab in combination with nivolumab
15993034|NCT02941731|Drug|HIP1403|Oseltamivir 6mg/mL
15993035|NCT02941731|Drug|HGP0919|Oseltamivir phosphate 6mg/mL
15993036|NCT02941718|Behavioral|Sleep Advancement Counseling|Participants will receive cognitive behavioral counseling on achieving adequate sleep duration.
15993037|NCT02941718|Behavioral|General Health Information|Participants will receive educational information on general health topics including diet, physical activity, skin protection, oral health and cancer screenings.
15993038|NCT02941705|Biological|Allogeneic Derived Cells|patients will have the CAP-1002 solution delivered through a coronary catheter inserted in the right and left coronary arteries using standard techniques in the cardiac catheterization laboratory. A right heart catheter will be used to obtain baseline (pre-infusion) hemodynamics.
15993039|NCT02941705|Biological|Placebo/Control Arm|patients will receive the placebo through a coronary catheter inserted in the right and left coronary arteries using standard techniques in the cardiac catheterization laboratory. A right heart catheter will be used to obtain baseline (pre-infusion) hemodynamics.
15993040|NCT02941692|Drug|Oxytocin|
15993041|NCT02941692|Drug|Placebo|Placebo for Oxytocin
15993042|NCT02941679|Drug|HCP1202|Hanmi Pharmaceutical. Co., Ltd.
15993043|NCT02941679|Drug|HGP1011|Boehringer Ingelheim
15993044|NCT02941679|Drug|HCP0910|GlaxoSmithKline
15993045|NCT02941653|Device|Potassium nitrate 2% gel|"Teeth will be cleaned using rubber cups associated to pumice and water;
~Relative isolation with roller cotton will be done;
~Prior to each bleaching session, the patients will receive the potassium nitrate 2% desensitivity gel application on vestibular surface, for 10 minutes.
~Gingival dam will be performed using a fluid resin (Top Dam, FGM, Brazil)
~A 35% hydrogen peroxide based bleaching agent will be mixed and applied on the vestibular surface of teeth, remaining for 40 minutes."
15993046|NCT02941653|Device|Potassium oxalate 5% gel|"Teeth will be cleaned using rubber cups associated to pumice and water
~Relative isolation with roller cotton will be done;
~Prior to each bleaching session, the patients will receive the potassium OXALATE 5%
~Gingival dam will be performed using a fluid resin (Top Dam, FGM, Brazil) desensitivity gel application on vestibular surface, for 10 minutes.
~A 35% hydrogen peroxide based bleaching agent will be mixed and applied on the vestibular surface of teeth, remaining for 40 minutes."
15993047|NCT02941640|Procedure|E group|The securing the base of appendix by endoloop.
15993048|NCT02941640|Procedure|S group|The securing the base of appendix by Stapler.
15993049|NCT02941640|Procedure|H group|The securing the base of appendix by Hem-o-lok clip.
15993050|NCT02941640|Procedure|DS group|The securing the base of appendix by DS clip.
15993051|NCT02941640|Device|Endoloop|
15993052|NCT02941640|Device|Stapler|
15993053|NCT02941640|Device|Hem-o-lok clip|
15993054|NCT02941640|Device|DS clip|
15993055|NCT02941627|Device|Neuro Cochlear Implant System|
15993056|NCT02941614|Behavioral|Distress screening|A brief depression and anxiety screening instrument, the Patient Health Questionnaire-9 (PHQ-9), will be administered to newly diagnosed breast cancer patients in the Distress Screening arm.
15993057|NCT02941601|Drug|Necitumumab|Administered IV
15993058|NCT02941601|Drug|Gemcitabine|Administered IV
15993059|NCT02941601|Drug|Carboplatin|Administered IV
15993060|NCT02941588|Procedure|Non-cardiac surgery|Any surgery with general anesthesia except cardiac surgery
15993061|NCT02941575|Other|Crystal Ultra|Crystal Ultra: is a resin nano-ceramic material, that combines both advantages of ceramics and composites.
15993062|NCT02941575|Other|All ceramic|IPS Emax: is an all ceramic crown that has proven superior aesthetics and strength properties.
15993063|NCT02941562|Radiation|Short-course radiotherapy|Preoperative Radiation doses: 25 Gy in 5 fractions to the pelvis
15993064|NCT02941562|Drug|FOLFOX4 chemotherapy,preoperative|"FOLFOX4 chemotherapy：5-FU 400 mg/m2 i.v. bolus and Leucovorin 200 mg/m2 i.v. followed by 5-FU 600 mg/m2 i.v. 22 h-infusion day 1 + 2, oxaliplatin 85 mg/m2 day 1.
~Repeat every 2 weeks"
15993065|NCT02941562|Radiation|Radiotherapy of neo-adjuvant therapy|Preoperative Radiation doses: 45 Gy in 25 fractions to the pelvis, 5.4 Gy in 3 fractions to the pelvis
15993066|NCT02941562|Drug|Concurrent chemotherapy of neo-adjuvant therapy|Capecitabine 825mg/m2 twice daily 5 days/week
15993067|NCT02941562|Procedure|Radical rectal cancer resection|Radical rectal cancer resection
15993068|NCT02941562|Drug|FOLFOX4 chemotherapy,post-operative|"FOLFOX4 chemotherapy：5-FU 400 mg/m2 i.v. bolus and Leucovorin 200 mg/m2 i.v. followed by 5-FU 600 mg/m2 i.v. 22 h-infusion day 1 + 2, oxaliplatin 85 mg/m2 day 1.
~Repeat every 2 weeks"
15993069|NCT02941549|Other|Placebo capsules|
15993070|NCT02941549|Drug|DS102|
15993071|NCT02941536|Diagnostic Test|Circulating tumor cells evaluation|Sample collection of circulating tumor cells (CTC) before and 4-5 weeks after focal stereotactic radiotherapy in single (SRS) or fractionated (SFRT) dose.
15993072|NCT02941523|Drug|NOX66|NOX66 administration
15993073|NCT02941523|Drug|Carboplatin|Carboplatin administration
15993075|NCT02941510|Other|Placebo|Subject(s) will participate in all study activities but will receive placebo.
15993076|NCT02941497|Behavioral|Social marketing and health promotion campaign|Students in the intensive intervention group developed a nine-month social marketing health campaign. The campaign included five costumed characters who interacted with students on campus in residence halls, dining halls, and other highly-trafficked public areas on campus. Photos and videos of interactions were put on social media. Student participants from the general population (the diffuse intervention group) were asked to set weekly healthy goals related to diet, physical activity, and stress management throughout the campaign and received email and text messages with goal-specific written and video health-promotion messages. Faculty partnered with the students throughout the intervention process to educate and give advice on the content of health promotion messages.
15993077|NCT02941484|Procedure|early oral intake|early oral intake is started within 24 hours after pancreaticoduodenectomies following to the ERAS guideline
15993078|NCT02941484|Procedure|jejunostomy tube feeding (JTF)|The jejunostomy tube was placed using the Flocare CH-10 tube with the longitudinal Witzel jejunostomy technique.nutrition is supplemented via JTF rather than early oral intake.Velocity is progressively increased by 20ml/hr until full nutritional goal (25Kcal/Kg)
15993079|NCT02941471|Device|Interferential Stimulation|Transabdominal interferential electrcial stimulation
15993080|NCT02941471|Device|TENS stimulation|Transabdominal standard electrical stimulation
15993081|NCT02941445|Drug|sitagliptin and metformin|
15993082|NCT02941445|Drug|Metformin|
15993083|NCT02941432|Other|Black tea compress treatment|Wet compresses with black tea applied 4-5 times daily to the face for 6 days
15993084|NCT02941419|Biological|Platelet lysate|Autologous intramuscular platelet lysate injection for patients with peripheral arterial disease
15993085|NCT02941393|Device|Intrauterine pressure catheter|
15993086|NCT02941393|Device|External tocodynamometry|
15993087|NCT02941367|Drug|Lixisenatide (AVE0010)|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous"
15993088|NCT02941367|Drug|Sulfonylurea|"Pharmaceutical form: tablet
~Route of administration: oral"
15993089|NCT02941367|Drug|metformin|"Pharmaceutical form: tablet
~Route of administration: oral"
15993090|NCT02941367|Drug|basal insulin|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous"
15993091|NCT02941354|Drug|turoctocog alfa|Each subject will receive a single dose of turoctocog alfa as an intravenous (i.v.) bolus injection of 50 IU/kg.
15993092|NCT02941341|Drug|r-hFSH|As per standard practice
15993093|NCT02941328|Drug|Pyridostigmine|Pyridostigmine, administered orally starting with 2mg/kg/day (in 4 daily doses, i.e. 0,5mg/kg/dose) and slowly increasing to a maximum dosage of 6mg/kg/day (4 daily doses of 1,5mg/kg/day)
15993094|NCT02941328|Drug|Placebo|Placebo administered orally starting with 2mg/kg/day (in 4 daily doses, i.e. 0,5mg/kg/dose) and slowly increasing to a maximum dosage of 6mg/kg/day (4 daily doses of 1,5mg/kg/day)
15993095|NCT02941315|Drug|etiologic treatment,anti-myocardial remodeling|When the etiology was diagnosed clearly by cardiac magnetic resonance(CMR), participants were treated with drugs including etiologic treatment,anti-myocardial remodeling according to guidelines for treatment of cardiomyopathy.
15993096|NCT02941315|Drug|anti-myocardial remodeling|When the etiology was not diagnosed clearly by cardiac magnetic resonance(CMR), in participant without companioned with acute heart failure, participants were treated with drugs including anti-myocardial remodeling according to guidelines for treatment of cardiomyopathy.
15993097|NCT02941315|Drug|anti-myocardial remodeling,anti-acute heart failure|When the etiology was not diagnosed clearly by cardiac magnetic resonance(CMR), in participant companioned with acute heart failure, participants were treated with drugs including anti-myocardial remodeling and anti- acute failure according to guidelines.
15993098|NCT02941315|Drug|Etiological, anti-remodeling and symptom treatment|When the etiology was diagnosed clearly by cardiac magnetic resonance(CMR), in participants were companioned with acute heart failure, the participant should be treated with drugs including etiologic treatment,anti-myocardial remodeling and anti-acute heart failure according to guidelines for treatment of cardiomyopathy.
15993099|NCT02941302|Procedure|Detecting of Biological Borders of Gliomas|Neural navigation combined with Intraoperative ultrasound detecting the borders of gliomas, In accordance with established plan to collect multiple targets undergo pathological examination and contrast with imaging boundary to determine the biological boundaries.
15993100|NCT02941289|Procedure|visual search performance of everyday objects in realistic scenes|
15993101|NCT02941276|Device|Active Electrostimulator device|Patients who will receive a fully functioning device
15993102|NCT02941276|Device|Sham Electrostimulator device|Patients who will receive a device that does not release electric stimuli (but provided mechanical/tactile stimulation)
15993103|NCT02941250|Device|ISSD emulator|induced tachy-arrhythmia to be terminated by ISSD emulator
15993104|NCT02941237|Device|Pulse oximeter|"Time taken to measure oxygen saturation.
~Completion of usability questionnaire"
15993105|NCT02941224|Device|SELUTION DCB (sirolimus coated balloon)|
15993106|NCT02941211|Device|Aqueduct -100|
15993107|NCT02941198|Device|GyneFix|The fiber is fixed to the anchoring thread by means of a stainless steel clip 1 cm from the upper part of the anchoring knot. The anchoring knot is implanted into the myometrium of the uterus thus permanently securing the implant in the uterine cavity
15993108|NCT02941198|Device|Cu T380 A|Cu T380 A will be inserted into the uterus
15993109|NCT02941185|Drug|Devit-3 Oral Drop|
15993110|NCT02941172|Other|Cold exposure|Controlled cold exposure is performed before and during PET scan
15993111|NCT02941172|Other|[18F]FMPEP-d2|PET radiotracer used in imaging
15993112|NCT02941172|Other|[18F]FDG|PET radiotracer used in imaging
15993113|NCT02941159|Biological|SF2000SD|This is an intergrase inhibitor
15993114|NCT02941159|Biological|Placebo|
15993115|NCT02941146|Device|The ZELTIQ System|The CoolSculpting System will be used to perform the treatments with the CoolAdvantage family of applicators.
15993116|NCT02941133|Other|Neural Mobilization|Neural mobilization techniques aimed at the lumbar root that is affected
15993117|NCT02941133|Other|Standard Care|Ultrasound - Transcutaneous electrical nerve stimulation (TENS) - Massage therapy - Strengthening exercises
15993290|NCT02939976|Device|Terumo TR Band Radial Compression Device|Possible use of Terumo TR Band Radial Compression Device
15993118|NCT02941107|Drug|Rotarix (RV1)|ROTARIX™ (RV1) is a live-attenuated human monovalent oral vaccine containing attenuated G1P[8] human rotavirus strain sponsored and distributed in Australia by GlaxoSmithKline Biologicals where it is licensed for the prevention of rotavirus gastroenteritis.
15993119|NCT02941107|Drug|Placebo|The placebo for this trial will be Viscosweet, a clear and flavoured solution used as a pharmaceutical excipient repackaged into a labelled syringe identical to the active and firmly sealed with an end cap.
15993120|NCT02941094|Device|needle PLT-805AT|comparing success rate and complications using different needle to US probe angles.
15993121|NCT02941094|Device|Ultrasound|Xario, Toshiba Tokyo Japan
15993122|NCT02941081|Dietary Supplement|IHAT|1 dose/day single IMP containing IHAT powder bioequivalent to 12.5 mg Fe (i.e. 20 mg Fe taking into account IHAT's relative bioavailability to FeSO4)
15993123|NCT02941081|Dietary Supplement|Ferrous Sulphate|1 dose/day single IMP containing FeSO4 powder equivalent to 12.5 mg Fe
15993124|NCT02941081|Other|Placebo|1 dose/day containing a placebo powder (no-iron, 'sugar' compound)
15993125|NCT02941068|Drug|fluconazole and caspofungin|
15993126|NCT02941055|Other|Fiber diet|Foods will be delivered with a home delivery chain once a week for 10 wks of each diet
15993127|NCT02941055|Other|Protein diet|Foods will be delivered with a home delivery chain once a week for 10 wks of each diet
15993128|NCT02941042|Drug|NNC9204-1177|A single dose administered subcutaneously ( s.c. under the skin)
15993129|NCT02941042|Drug|Placebo|A single dose administered subcutaneously ( s.c. under the skin)
15993130|NCT02941029|Other|Plasma Blood collection|Plasma blood collection is collected at specific intervals prior to and during radiation treatment.
15993131|NCT02941016|Drug|Evolocumab or Alirocumab|All patients are treated with PCSK-9 inhibitors (Evolocumab or Alirocumab) to lower cholesterol
15993132|NCT02941003|Device|microscope|Detection of of histopathological characteristics of OCT treatment or OCT free samples from patients .
15993133|NCT02941003|Other|immunostaining|Detection of CD31/CD34, D2-40, Ki67 and p53 immunostaining of OCT treatment or OCT free samples from patients .
15993134|NCT02941003|Device|NGS|The investigators used the device to detect the gene mutations of OCT treatment or OCT free samples obtained from part of the patients.
15993135|NCT02940990|Radiation|SBRT concurrent with GM-CSF|SBRT and GM-CSF 125ug/m2 for 14 days
15993136|NCT02940990|Drug|two-drug chemotherapy containing platinum, including carboplatin/Cisplatin + pemetrexed/docetaxel/paclitaxel/etoposide/gemcitabine/vinorelbine/albumin-bound paclitaxel|two-drug regimen
15993137|NCT02940977|Other|Blood draws|Blood draws, from peripheral veins, each time 2 tubes, each 5 ml.
15993138|NCT02940964|Behavioral|Count on me Singapore (COMS) CPR|Using the song as a mental metronome to guide CPR.
15993139|NCT02940964|Behavioral|Standard CPR|"Standard CPR with one-and-two-and-three.... counting"
15993140|NCT02940951|Other|QPSS|Home care providers use the QPSS that includes standardized instruments for assessing patient and family caregiver quality of life in routine care. In addition to instant calculation of scores, the QPSS allows for tracking scores over time and sharing them with other registered users from that home care service.
15993141|NCT02940951|Other|Usual care|Home healthcare services provided by nurses and, where applicable, multi-professional teams.
15993142|NCT02940938|Other|Applying pulse oximeter sensor|During general anesthesia, pulse oximeter sensor is applied with gradually increased contact force, from 0 to 1.5N (increase by about 0.2N), at an index finger and POP waveform is obtained for 60 seconds.
15993143|NCT02940925|Other|Drug: Taxol,cisplatin and capecitabine|Taxol, cisplatin and capecitabine as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.
15993144|NCT02940925|Other|Drug: Cisplatin and 5-Fluorouracil|Cisplatin and 5-Fluorouracil as induction chemotherapy combined with cisplatin concurrent chemoradiotherapy with intensity modulated radiation therapy.
15993145|NCT02940912|Drug|Apomorphine|cross-over with start with Apokinon in the 1st phase- in the 2nd phase of continuous treatment with Physiologic Serum.
15993146|NCT02940912|Drug|Placebo|cross-over with start with.Physiologic Serum in the 1st phase- in the 2nd phase of continuous treatment with Apokinon.
15993147|NCT02940899|Other|Intervention: Syracuse University Fir Families Program (SUFFP)|The SUFFP (Syracuse University Fit Families Program) is a randomized clinical trial, were 40 children with autism spectrum disorders ages 5-11 and at least one parent were randomly assigned to one of two group-based conditions; interventions or a control wait list group.
15993148|NCT02940886|Drug|Iron isomaltoside/ferric derisomaltose|"Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.
~The dose of iron isomaltoside/ferric derisomaltose for the individual subject was set to 1000 mg. The dose was diluted in 100 mL 0.9 % sodium chloride (100 mL bags) and administered as a single IV infusion over approximately 20 minutes."
15993149|NCT02940886|Drug|Iron sucrose|"Iron sucrose (Venofer®; 20 mg elemental iron/mL) was the comparator in this trial.
~Iron sucrose was administered as 200 mg undiluted IV injections over approximately 2-5 minutes and repeated according to standard practice or physician choice up to a maximum of five times within the first two weeks starting at baseline. A cumulative dose of 1000 mg was recommended."
15993150|NCT02940873|Behavioral|HARPdoc courses|A six week group education package including hypoglycaemia-focussed cognitive behavioural therapy
15993151|NCT02940873|Behavioral|BGAT courses|A structured psycho-education programme focussing on better prediction and recognition of high and low blood glucose values
15993152|NCT02940860|Drug|Iron isomaltoside/ferric derisomaltose|"Iron isomaltoside/ferric derisomaltose (Monofer®/Monoferric®; 100 mg/mL) was the test product in this trial.
~The dose of iron isomaltoside/ferric derisomaltose for the individual subject was set to 1000 mg. The dose was diluted in 100 mL 0.9 % sodium chloride (100 mL bags) and administered as a single IV infusion over approximately 20 minutes."
15993153|NCT02940860|Drug|Iron sucrose|Iron sucrose (Venofer®; 20 mg elemental iron/mL) was the comparator in this trial. Iron sucrose was administered as 200 mg undiluted IV injections over approximately 2-5 minutes and repeated according to standard practice or physician choice up to a maximum of five times within the first two weeks starting at baseline. A cumulative dose of 1000 mg was recommended.
15993288|NCT02939976|Device|Volcano based pressure wires Verrata, Verrata Plus and any subsequent marketed Volcano pressure wire technology|Complete revascularization of all diseased arteries
15993154|NCT02940847|Procedure|medial brachial cutaneous nerve block and intercostobrachial nerve block with blind technique|It consists in performing a subcutaneous injection of the local anesthetic at the root of the arm, in the anterior-posterior direction.
15993155|NCT02940847|Procedure|medial brachial cutaneous nerve block and intercostobrachial nerve block with ultrasound-guided technique|Ultrasounds are used to visualize the anatomical variations, the good position of the needle and the good local anesthetic diffusion.
15993156|NCT02940821|Other|Toothbrushing|Mechanical plaque removal
15993157|NCT02940821|Other|Fluoridated Dentifrice (.15% sodium monofluorophosphate)|Fluoridated dentifrice application
15993158|NCT02940821|Other|Fluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide)|Application of Tooth Whitening Agent in Dentifrice
15993159|NCT02940821|Other|Whitening (4.5% hydrogen peroxide)|Application of Whitening Agent
15993160|NCT02940821|Other|Other Fluoridated Dentifrice (.454% stannous fluoride)|Fluoridated dentifrice application
15993161|NCT02940808|Dietary Supplement|Caffeine (200mg)|Oral consumption of capsule containing 200mg caffeine.
15993162|NCT02940808|Other|Placebo|Oral consumption of capsule containing a placebo substance.
15993163|NCT02940795|Other|Coke|Patients were given a 20 ounce bottle of Coke Cola.
15993164|NCT02940795|Other|Diet Rite|Patients were given a 12 ounce can of Diet Rite.
15993165|NCT02940782|Procedure|Reciproc single file system|A reciprocating Nickel Titanium single file system used for instrumentation of root canals in endodontic treatment.
15993166|NCT02940782|Procedure|One Shape single file system|A rotary Nickel Titanium single file system used for instrumentation of root canals in endodontic treatment.
15993167|NCT02940782|Device|X-smart Plus, Dentsply Maillefer, Ballaigues, Switzerland|It is a micro-motor designed for performing root canal treatments with the reciprocating, single file technique or traditional continuous rotation file system.
15993168|NCT02940769|Device|light glasses|light glasses
15993169|NCT02940769|Device|sham glasses (placebo)|sham light glasses
15993170|NCT02940756|Drug|artesunate-amodiaquine|Tablets containing 25 mg of artesunate and 67.5 mg of amodiaquine: one tablet daily for three days children weighing 4.5 to 8 kg, and tablets containing 50 mg of artesunate and 135 mg of amodiaquine: one tablet daily for three days for children weighing 9 to 17 kg.
15993171|NCT02940756|Drug|artemether-lumefantrine|"Tablets containing 20 mg of Artemether and 120 mg of Lumefantrine. Each dose to be taken with high-fat food or drinks (for example milk).
~One tablet twice daily for children weighing 5 to <15 kg, two tablets twice daily for those weighing 15 to <25 kg and three tablets twice daily for those weighing 25 to < 35 kg, for three days."
15993172|NCT02940756|Drug|Dihydroartemisinine-piperaquine|Tablets containing 20 mg of dihydroartemisinine and 160 mg of piperaquine. Half a tablet once daily for children weighing 5 to <7 kg, one tablet once daily for those weighing 7 to <13 kg, and two tablets once daily for those weighing 13 to <24 kg, for three days.
15993173|NCT02940743|Behavioral|Education (Edu)|This intervention will take place during weeks 1-4 at the dialysis center. Each week, study staff will present participants with a brief educational video on: phosphorus binder adherence (week 1), meeting dietary protein needs (week 2), restricting dietary sources of phosphorus (week 3), and eliminating phosphorus-based food additives (week 4). These videos will be loaded onto tablet (Personal Computers) PCs so that participants can easily view them during regular dialysis treatment.
15993174|NCT02940743|Behavioral|SM intervention|During the first 12 weeks of the intervention, a study dietitian will review the participants' records, and provide individualized feedback via a password-protected NYULMC email address. Feedback will be provided twice per week during weeks 1-4, once per week during weeks 5-8, and once every two weeks during weeks 9-12. The email messages will focus on both the importance of self-monitoring and the behavioral targets of the intervention. Feedback will use standardized language rather than specific dietary examples to avoid providing individualized counseling to participants (which is not the purpose of the SM intervention).
15993175|NCT02940743|Behavioral|Social Cognitive Therapy (SCT)|This intervention will be delivered remotely online using the same tablet PCs provided for the SM intervention component of this treatment condition. The behavioral training program will focus on building a sense of self-efficacy with emphasis on mastery experiences that will include emphasizing past successes; setting incremental, easily achievable goals; self-monitoring to stay on track; identifying modifiable barriers to healthy behavior; positive feedback in goal achievement; and developing participant expertise in both the regimen and in problem solving around barriers to adherence.
15993176|NCT02940730|Drug|Dalbavancin via Intravenous Administration|Patients will undergo plasma fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange.
15993177|NCT02940730|Drug|Dalbavancin via Intraperitoneal Administration|Patients will undergo peritoneal fluid pharmacokinetic sampling for determination of dalbavancin concentrations at time zero, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours, at time of volume exchange.
15993178|NCT02940717|Other|Vita suprinity|New glass ceramic material
15993179|NCT02940717|Other|Emax CAD|standard etchable glass ceramic used for laminate venneers
15993180|NCT02940704|Procedure|Reciproc|"Canals will be instrumented using Reciproc reciprocating system set on an electric motor, with adjusted torque and speed according to the manufacturer's instructions.
~There is no need for coronal preflaring with a Gates Glidden drill or an orifice opener since the design of the Reciproc instrument allows any obstructions in the coronal third to be removed, as claimed by the manufacturer.
~Reciproc file selection: R40 (40/0.06) is to be used."
15993181|NCT02940704|Procedure|One Shape|"Coronal preflaring will be performed using Gates Glidden drill.
~Canals will be instrumented using One Shape single-file (25/0.06) set on an electric motor with adjusted torque and speed according to the manufacturer's instructions.
~For wide canals, One Shape Apical (30/0.06, 37/0.06) will be used."
15993182|NCT02940691|Drug|Grazoprevir/elbasvir|Grazoprevir/elbasvir (100mg/50mg) once daily for 12 weeks.
15993183|NCT02940678|Other|No intervention|
15993184|NCT02940665|Other|ERAS|Patients in the ERAS group received the ERAS protocol
15993185|NCT02940652|Radiation|Magnetic resonance imaging|No intervention - description of the position of the LMA obtained during routine elective MRI scanning of the brain and/or cervical spine
15993186|NCT02940626|Drug|ASN100|monoclonal antibody combination of ASN-1 and ASN-2
15993187|NCT02940626|Drug|Placebo|Placebo
15993188|NCT02940613|Behavioral|Visual feedback of symptom frequency|Participants receive visual feedback of their symptom frequency over the first 4 weeks of active treatment, based on information they provide on a symptom checklist.
15993189|NCT02940600|Device|Normothermic machine perfusion|Patients undergoing liver transplant with the use of grafts preserved with normothermic perfusion machine
15993190|NCT02940600|Procedure|Static cold storage|Patients undergoing liver transplant using statically cold preserved grafts
15993191|NCT02940587|Device|Aurix|Aurix is a platelet-rich plasma gel used in the treatment of non-healing wounds. It will be administered twice weekly for 2 weeks then weekly.
15993192|NCT02940574|Drug|Syntocinon (Oxytocin)|Syntocinon nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray
15993193|NCT02940574|Other|Placebo (Physiological water (solution of sodium chloride (NaCl) in water))|Placebo nasal spray. A single dose (24IU) of nasal spray (3 puffs of 4IU per nostril), followed by 4 weeks of a daily single dose (24IU; 3 puffs of 4IU per nostril) of nasal spray
15993194|NCT02940561|Drug|Methotrexate - Amneal|"Methotrexate Tablets, USP contain an amount of methotrexate sodium equivalent to 2.5 mg of methotrexate, USP and are round, biconvex, yellow tablets, scored in half on one side, engraved with A above the score and 1 below"
15993195|NCT02940561|Drug|Methotrexate - DAVA|Methotrexate Tablets, USP contain an amount of methotrexate sodium equivalent to 2.5 mg of methotrexate and are round, convex, yellow tablets, scored in half on one side, engraved with M above the score, and 1 below
15993196|NCT02940548|Drug|Nifedipine GITS|Nifedipine GITS 30~60mg/day for 8 weeks
15993197|NCT02940548|Drug|Amlodipine besylate|Amlodipine besylate 5~10mg/day for 8 weeks
15993198|NCT02940535|Drug|Diphereline (Triptorelin embonate)|
15993199|NCT02940535|Drug|Decapeptyl (Triptorelin)|
15993200|NCT02940535|Drug|human menopausal gonadotropin|
15993201|NCT02940535|Drug|human chorionic gonadotropin|
15993202|NCT02940522|Drug|Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)|
15993203|NCT02940522|Drug|Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)|
15993204|NCT02940509|Drug|Ketamine plus Magnesium sulfate|"Patients will receive 2 IV infusions:
~Ketamine (0.5mg/kg)
~Magnesium sulfate (2g)"
15993205|NCT02940509|Drug|Placebo|Patients will receive 2 IV infusions, both of NaCl 0.9%, as placebos for Ketamine and magnesium sulfate
15993206|NCT02940496|Drug|Elbasvir/Grazoprevir|Given PO
15993207|NCT02940496|Other|Laboratory Biomarker Analysis|Correlative studies
15993208|NCT02940496|Biological|Pembrolizumab|Given IV
15993209|NCT02940496|Drug|Ribavirin|Given PO
15993210|NCT02940483|Drug|5-Azacytidine|5-Azacytidine 10 mg into the fourth ventricle of the brain via the Ommaya reservoir 1 day a week for 12 weeks.
15993211|NCT02940470|Other|Calorie restricted diet plus exercise|Daily meals plus exercise providing 1000 kcal restriction per day for 12 weeks.
15993212|NCT02940470|Other|Weight management classes|Weekly 1-hour weight management classes for 12 weeks.
15993213|NCT02940457|Device|Verum tDCS|Neuropsychological (working memory) training for 30 minutes, 6 sessions tDCS during training with 2 mA
15993214|NCT02940457|Device|Sham tDCS|Neuropsychological (working memory) training for 30 minutes, 6 sessions tDCS during training with 0 mA
15993215|NCT02940444|Drug|Heparin|
15993216|NCT02940431|Other|High Autonomy|Children will be given two active video games (AVGs) of their choice. After two weeks, a researcher will monitor progress and exchange the AVGs and sedentary games. At each exchange, children will be allowed to select their next game.
15993217|NCT02940431|Other|Low Autonomy|Children will be given their most-liked active video game (AVG) from the baseline relative reinforcing value assessment. After two weeks, a researcher will monitor progress and exchange the AVGs and sedentary games. At each exchange, children will receive a pre-determined game.
15993218|NCT02940418|Biological|Adipose mesenchymal cells with bone marrow mononuclear cells|Allogenic adipose-derived mesenchymal cells with autologous bone marrow mononuclear cells will be injected.
15993219|NCT02940405|Drug|Ketorolac Tromethamine|A 10 mg tablet of the medication will be given one hour before starting the root canal treatment
15993220|NCT02940405|Drug|Placebo|The placebo given as a tablet one hour before staring the root canal treatment
15993221|NCT02940392|Device|Rezum System|"The Rezūm System is designed to treat patients with bothersome urinary symptoms associated with benign prostatic hyperplasia (BPH). The Rezūm System utilizes radiofrequency current to generate wet thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate tissue in controlled 9-second doses. The vapor that is injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue and the stored thermal energy is released, denaturing the cell membranes and causing cell death.
~The denatured cells are absorbed by the body, which reduces the volume of prostate tissue adjacent to the urethra. The vapor condensation process also causes a rapid collapse of vasculature in the treatment zone, resulting in a bloodless procedure."
15993222|NCT02940379|Drug|sotagliflozin (SAR439954)|"Pharmaceutical form: tablet
~Route of administration: oral"
15993223|NCT02940379|Drug|midazolam|"Pharmaceutical form: HCl syrup
~Route of administration: oral"
15993224|NCT02940379|Drug|metoprolol|"Pharmaceutical form: tablet
~Route of administration: oral"
15993225|NCT02940366|Drug|Pitavastatin 4 mg orally daily|Pitavastatin 4 mg orally daily for 24months
15993226|NCT02940366|Drug|Atorvastatin 20 mg orally daily|Atorvastatin 20 mg orally daily for 24months
15993227|NCT02940353|Device|TREFOIL concept|
15993228|NCT02940314|Drug|HIP1503|
15993229|NCT02940314|Drug|HGP1103|
15993230|NCT02940301|Drug|Ibrutinib|Given PO
15993231|NCT02940301|Other|Laboratory Biomarker Analysis|Correlative studies
15993232|NCT02940301|Biological|Nivolumab|Given IV
15993233|NCT02940288|Other|Auricular Acupuncture|Participants will receive bilateral auricular acupuncture using the Battlefield Acupuncture (BFA) protocol while in the Post Analgesia Care Unit (PACU) following laparoscopic surgery. Acupuncture needles will be left in place for 30 minutes.
15993289|NCT02939976|Device|Terumo Glidesheath Slender|Possible use of Terumo Glidesheath Slender
15993328|NCT02939690|Device|UVC|UVC insertion depth calculated by [(3× birth weight (Kg) + 9)/2+1)]
15993234|NCT02940288|Other|Sham Acupuncture|Participants will receive sham acupuncture while in the Post Analgesia Care Unit (PACU) following laparoscopic surgery. During the sham procedure, needles will be inserted bilaterally in five nonspecific ear acupoints. Acupuncture needles will be left in place for 30 minutes.
15993235|NCT02940262|Radiation|Gallium Ga 68 Gozetotide|Given IV
15993236|NCT02940262|Other|Laboratory Biomarker Analysis|Correlative studies
15993237|NCT02940262|Procedure|Positron Emission Tomography|Undergo PET imaging
15993238|NCT02940249|Dietary Supplement|Apple polyphenols|Drinks will be delivered in random order at 4 separate study visits immediately before a high-carbohydrate meal. Seven days wash-out period will be required between study days.
15993239|NCT02940249|Dietary Supplement|Placebo|
15993240|NCT02940236|Other|Ultrasound|Before and after patient receives oral multimodal analgesia as per standard of care, two ultrasound scans will be performed (10 minutes apart for each time element).
15993241|NCT02940223|Drug|Ethyl Icosapentate|Given by mouth 2 gm orally daily plus physical activity
15993242|NCT02940223|Behavioral|Exercise Intervention|Complete resistance exercises and undergo walking program
15993243|NCT02940223|Behavioral|Exercise Intervention|Meet with exercise specialist and complete stretching exercises
15993244|NCT02940223|Other|Laboratory Biomarker Analysis|Correlative studies
15993245|NCT02940223|Other|Placebo|Given PO
15993246|NCT02940223|Behavioral|Quality-of-Life Assessment|Ancillary studies
15993247|NCT02940223|Other|Questionnaire Administration|Ancillary studies
15993248|NCT02940210|Device|Mediclore® (adhesion barrier)|
15993249|NCT02940197|Behavioral|MediterrAsian diet|no other description
15993250|NCT02940184|Drug|Tablet Sitagliptin 100mg (evening before and morning of experiments)|On one of two experiment days participants will have Dipeptidyl peptidase 4 activity inhibited using a DPP-4 inhibitor (Sitagliptin).
15993251|NCT02940184|Other|Intestinal Fructose administration|On both experimental days fructose (35g dissolved in water, total volume 100mL) will be administered via an intrajejunal tube
15993252|NCT02940171|Procedure|Early Excision of full thickness burn|first excision surgery of full -thickness burn performed within 48 hours from burn injury
15993253|NCT02940171|Procedure|Late Excision of full thickness burn|first excision surgery of full -thickness burn performed after 48 hours from burn injury
15993254|NCT02940158|Other|1/4 cup- Small red lentil|
15993255|NCT02940158|Other|1/4 cup- Small green lentil|
15993256|NCT02940158|Other|1/4 cup- corn|
15993257|NCT02940158|Other|1/4 cup- macaroni|
15993258|NCT02940158|Other|1/4 cup- white potato|
15993259|NCT02940158|Other|1/4 cup- white rice|
15993260|NCT02940158|Other|1/2 cup- small red lentil|
15993261|NCT02940158|Other|1/2 cup- small green lentil|
15993262|NCT02940158|Other|1/2 cup- corn|
15993263|NCT02940158|Other|1/2 cup- macaroni|
15993264|NCT02940158|Other|1/2 cup- white potato|
15993265|NCT02940158|Other|1/2 cup- white rice|
15993266|NCT02940145|Other|Resistance Training|The investigation was carried out over a period of 16 weeks, with 12 weeks dedicated to the RT program and 4 weeks allocated for measurements. Anthropometric, body composition, and blood samples measurements were performed at weeks 1-2, and 15-16. A supervised progressive RT was performed between weeks 3-14. The CG did not perform any type of physical exercise during this period.
15993267|NCT02940132|Drug|SC10914|SC10914 will be administered orally.
15993268|NCT02940119|Device|Multi Radiance Medical®|Volunteers received all procedures of the study with active or placebo phototherapy (PBMT) in 9 sites of the neck and shoulders, twice a week. The PBMT was applied in all sessions.
15993269|NCT02940106|Device|Cryotop device|a different device for oocyte vitrification (with a very high cooling rate)
15993270|NCT02940106|Device|CBSvit device|a different device for oocyte vitrification (with a lower cooling rate)
15993271|NCT02940093|Other|Stem cell transplantation|Intervention is not conducted as part of the study but patients at Tübingen University Hospital undergoing this intervention as part of their standard care are being monitored in this observational study.
15993272|NCT02940080|Other|Dietary|
15993273|NCT02940067|Other|MedEx|A combination of dietary and exercise interventions over four weeks before scheduled pancreatic surgery
15993274|NCT02940054|Other|Red-flags questionnaire|A questionnaire composed by 8 items will be administered by GPs to those patients and they will be referred to a gastroenterologist with expertise in CD. All those patients will be evaluated, as per usual practice, to confirm or exclude Crohn's disease.
15993275|NCT02940041|Procedure|Pre-surgical diagnosis of uterine malignant tumors|All patientes who fit inclusion criteria will undergo a gynecologic sonography, pelvic MRI, determination of LDH, as in regular practice. No additional interventions will be done to any patient.
15993276|NCT02940028|Behavioral|Expressive writing|Brief expressive writing intervention
15993277|NCT02940028|Behavioral|Control writing|Brief fact-based writing exercise.
15993278|NCT02940002|Drug|BAY1003803|Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect
15993279|NCT02940002|Drug|Clobetasol propionate|Simultaneous application of 10μl on psoriasis plaque and on healthy skin for 4 weeks and evaluation of pharmacodynamic effect
15993280|NCT02940002|Drug|Betamethasone/calcipotriene|Simultaneous application of 10μl on healthy skin for 4 weeks and evaluation of pharmacodynamic effect
15993284|NCT02939976|Device|Single Vessel Disease|Revascularization with Medtronic Resolute family of stents in infarct related artery; Possible use of Terumo Glidesheath Slender and Terumo TR Band Radial Compression Device
15993285|NCT02939976|Procedure|Multi-vessel Disease, Culprit Vessel Only|Revascularization with Medtronic Resolute family of stents in infarct related artery; Possible use of Terumo Glidesheath Slender and Terumo TR Band Radial Compression Device
15993286|NCT02939976|Procedure|Multi-vessel Disease, Complete Revascularization|Complete revascularization of all diseased arteries
15993287|NCT02939976|Device|Medtronic Resolute family of stents|Revascularization with Medtronic Resolute family of stents in infarct related artery
15993424|NCT02938949|Drug|alirocumab|
15993291|NCT02939963|Procedure|ATC then pressure support 7 cm H2O PEP 4 cm H2O|spontaneous breathing through endotracheal tube with no ventilator support except for ATC, the patient is connected to the ventilator with pressure support 0 cm H2O and PEP 4 cm H2O during 30 minutes then 30 minutes of basal pressure support then 30 minutes with pressure support 7 cm H2O PEP 4 cm H2O
15993292|NCT02939963|Procedure|Pressure support 7 cm H2O PEP 4 cm H2O then ATC|30 minutes with pressure support 7 cm H2O PEP 4 cm H2O then 30 minutes of basal pressure support then 30 minutes with spontaneous breathing through endotracheal tube with no ventilator support except for ATC, the patient is connected to the ventilator with pressure support 0 cm H2O and PEP 4 cm H2O
15993293|NCT02939950|Device|Bausch + Lomb Samfilcon A Soft Contact Lens|soft contact lenses
15993294|NCT02939950|Device|Bausch + Lomb Pure Vision Soft Contact Lens|soft contact lenses
15993295|NCT02939937|Drug|Phenytoin|100 mg phenytoin three time daily for three months, and phenytoin levels will be taken at one and three months later.
15993296|NCT02939937|Drug|placebo|100 mg placebo three time daily for three months, and phenytoin levels will be taken at one and three months later.
15993297|NCT02939924|Device|Kanshas DCB|The appropriate Kanshas DCB size is selected after review of the patient's baseline angiogram and determination of the reference vessel diameter and lesion length. The balloons is sized to ensure the full length of the lesion is treated. The initial inflation of the study device should be approximately 1 minute for optimal drug release. In order to optimize lesion dilatation, longer inflation times are possible at the discretion of the operator.
15993298|NCT02939911|Device|Residual neuromuscular blockade measurement|Just prior extubation in OR and at the arrival to PACU the residual neuromuscular blockade will be measured by accelerometry
15993299|NCT02939898|Drug|Placebo|Adjuvant therapy to recFSH during ovarian stimulation
15993300|NCT02939898|Drug|Letrozole|Adjuvant therapy to recFSH during ovarian stimulation
15993301|NCT02939872|Drug|aspirin and clopidogrel|at the discretion of investigator
15993302|NCT02939872|Drug|Clopidogrel only|at the discretion of investigator
15993303|NCT02939859|Procedure|Microcannula Harvest Adipose|Use of Closed Syringe Microcannula Harvest Autologous Adipose-Derived Stem/Stromal Cells
15993304|NCT02939859|Device|Centricyte 1000|Use of Centricyte 1000 closed system digestion adipose tissue stromal vascular fraction to create a AD-cSVF
15993305|NCT02939859|Procedure|Sterile Normal Saline IV deployment AD-cSVF|Sterile Normal Saline Suspension AD-cSVF in 500 cc IV use
15993306|NCT02939846|Drug|Trametinib|Trametinib study will be provided as 0.5 mg and 2.0 mg tablets. Each tablet will contain 0.5 mg or 2.0 mg of trametinib parent (present as the DMSO solvate)
15993307|NCT02939833|Procedure|Scalp Nerve Blocks With Ropivacaine|
15993308|NCT02939833|Procedure|Scalp Nerve Blocks With Saline|
15993310|NCT02939807|Drug|ABC294640|"ABC294640 500 mg orally twice daily (approximately 12 hours apart) continuously.
~ABC294640 will be dosed under fasting conditions (at least 1 hour before or 2 hours after eating). A cycle is defined as 28 days."
15993311|NCT02939794|Drug|Ferinject|1000 mg of a ferric carboxymaltose (Ferinject type) intravenously approximately 24 hours prior to surgery
15993312|NCT02939794|Drug|Placebo|Saline (normal saline, sodium chloride)
15993313|NCT02939781|Device|Indirect calorimetry|Indirect calorimetry measurement at baseline (stable state), at onset of fever and continued till fever dehiscence
15993314|NCT02939768|Other|High-intensity interval training (HIIT)|The HIIT sessions will be performed on cycle ergometers and will be consisted of 10 x 60-s cycling intervals interspersed with 60 s recovery. Individual workloads will be selected to elicit ~90% maximal heart rate attained in the cardiorespiratory fitness test (HRmax). A passive or active recovery will be given among high-intensity stimulus. Each training session will include 3-min warm-up and 2-min cool-down phase performed ~50% (HRmax), totalling 25 min. This intervention will last 10 weeks.
15993315|NCT02939768|Other|Strength training (ST)|ST protocol will consist of three sets performed at maximum weight that participants could move eight times with good technique in the following exercises: supine bench press (pectoralis major), leg press (quadriceps, biceps femoris, gluteus maximus), lat pulldown (latissimus dorsi), leg extension (quadriceps), shoulder press (deltoids), leg curl (biceps femoris) and abdominal crunch (abdominal muscles). It will be given 1-min rest between series, totalizing approximately 35 min of ST. This intervention will last 10 weeks.
15993316|NCT02939768|Other|ST combined with HIIT (ST+HIIT)|Participants in the ST+HIIT group will execute ST and HIIT (in this order) above described in the same training session, lasting approximately 60 min. This intervention will last 10 weeks.
15993317|NCT02939755|Behavioral|Stepped collaborative care intervention|Using website that was specifically designed for advanced cancer patient, collaborative with treatment from health professional
15993318|NCT02939755|Behavioral|Enhanced Usual Care|usual care from health providers
15993319|NCT02939742|Drug|Betamethasone|Betamethasone 12mg IM given every 24 hours for two doses
15993320|NCT02939742|Drug|Placebo|Sterile 0.9% normal saline solution given IM every 24 hours for two doses
15993321|NCT02939729|Other|Walking Programme|Walking programme measured by daily step count on pedometer provided to participant. Participants will be advised to increase daily step count from their baseline measure - realistic incremental rise according to individual ability and symptoms. Daily step count will be recorded in a participant study diary.
15993322|NCT02939729|Device|Incentive Spirometer|An incentive spirometer is a device used to measure lung tidal volumes. Participants will be asked to use the incentive spirometer to measure their tidal volume daily. Participants will record daily tidal volume measurement in the participant diary. A physiotherapist will teach participants how to use the incentive spirometer and provide an instruction sheet.
15993323|NCT02939729|Other|Deep Breathing Exercises|Participants will be taught deep breathing exercises - these are the same deep breathing exercises shown to all patients after cardiac surgery as part of chest physiotherapy treatment. Participants will be asked to carry out deep breathing exercises at home during the prehabilitation phase. An instruction sheet for the deep breathing exercises will be provided to participants.
15993324|NCT02939716|Other|Rhubarb|300gm rhubarb
15993325|NCT02939716|Other|Bread|2 slices bread
15993326|NCT02939716|Other|Lettuce|300g lettuce
15993327|NCT02939703|Other|Diet|Participants will consume either a Control Western Diet or a Microbiome Enhancer Diet.
15993329|NCT02939690|Device|UVC|UVC insertion depth calculated by umbilicus to nipple distance-1
15993330|NCT02939690|Device|Ultrasound|
15993331|NCT02939677|Other|Targeted exercise|"12 weeks of targeted and supervised exercise intervention vs. care as usual (home based exercises)"
15993332|NCT02939664|Device|Banded (with polypropylene mesh) gastric bypass|The patient will be submitted to a Laparoscopic Roux-en-Y banded gastric bypass at the time of the operation, with a polypropylene mesh around the gastric pouch.
15993333|NCT02939664|Procedure|Gastric bypass|In this case a simplified conventional gastric bypass will be performed
15993334|NCT02939651|Drug|Pembrolizumab|Pembrolizumab given intravenously at a fixed dose of 200mg every 3 weeks
15993335|NCT02939638|Other|Plant-based diet|Weekly instructions will be given to the participants in the intervention group about following vegan diet.
15993336|NCT02939638|Other|Control Diet|Participants will be asked to continue their usual diets for the 16-week study period.
15993337|NCT02939625|Device|muscle training|
15993338|NCT02939625|Device|Continue Positive Airway Pressure|
15993339|NCT02939625|Device|bilevel positive airway pressure|
15993340|NCT02939612|Behavioral|App for stress management|An app consisting of 10 modules that teaches stress management, cognitive behavioral coping skills and relaxation training.
15993341|NCT02939599|Drug|QCC374|0.015mg and 0.06mg
15993342|NCT02939586|Procedure|Haemodiafiltration post-dilution model|Participants will be randomly assigned into either HD or HDF group. The participants will received the assigned treatment for 2 months, 1 month wash-out (HD) and cross-over to the other dialysis model- eg. HDF (2months) and switch to HD for 2 months, with 1 month washout period (using standard HD). Haemodialysis post-dilution model will be delivered using fresenius 5008 machine. Prescription for HDF post-dilution will be comparable to HD.
15993343|NCT02939586|Procedure|Haemodialysis|Participants will be randomly assigned into either HD or HDF group. The participants will received the assigned treatment for 2 months and cross-over to the other dialysis model- eg. HD (2months) and switch to HDF for 2 months, with 1 month washout period (using standard HD). Haemodialysis treatment will be delivered using fresenius 5008 machine. treatment time/parameters may vary depends on individual prescription.
15993344|NCT02939573|Drug|Colchicine|Randomized to colchicine 0.6 mg x 2/day
15993345|NCT02939573|Drug|Dapsone|Randomized to dapsone 150 mg/day
15993346|NCT02939573|Drug|Azathioprine|Randomized to azathioprine 2 mg/kg/day
15993347|NCT02939560|Device|NeuroStar® TMS device (Neuronetics, Atlanta, GA)|Participants in this study arm will be evaluated before and after receiving rTMS. Outcome measures will include social skills rating scales, depression rating scales and cognitive tasks while undergoing functional magnetic resonance imaging (fMRI).
15993348|NCT02939547|Drug|Hydroxypropyl-beta-cyclodextrin|Used in the treatment of Niemann-Pick Disease C1 ( NPC1)
15993349|NCT02939521|Procedure|Surgery|
15993350|NCT02939508|Other|Colon originated: Neostigmin, Colonoscopy decompression, Surgery|
15993351|NCT02939508|Other|Non-colon originated: Neostigmin, Colonoscopy decompression|
15993352|NCT02939495|Drug|Dapoxetine/Sildenafil 30/50 mg film coated tablet|1 tablet before sexual intercourse
15993353|NCT02939482|Drug|Triamcinolone Acetonide and normal saline solution|80 mg/2 ml Triamcinolone Acetonide and 18 ml normal saline solution
15993354|NCT02939469|Other|Physiologic maneuvers|"Subjects will perform
~Valsalva maneuver Hand Grip Post exercise cuff occlusion Loud Noise and Skin pinch"
15993355|NCT02939456|Other|Magnetic Resonance Imaging|Double Inversion Recovery Magnetic Resonance Imaging (DIR-MRI) and Dynamic Contrast Enhanced Magnetic Imaging (DCE-MRI)
15993356|NCT02939443|Radiation|supine- and prone-position Computed Tomography|
15993357|NCT02939430|Drug|Sugammadex intravenous|Intravenous Injection of sugammadex (2 mg/kg) for reversal of rocuronium induced muscle relaxation
15993358|NCT02939430|Drug|Intravenous neostigmine and atropine|
15993359|NCT02939417|Other|Grape seed extract|Grape seed extract - collagen cross-linking agent
15993360|NCT02939391|Drug|KW-6356|Oral administration
15993361|NCT02939391|Drug|KW-6356|Oral administration
15993362|NCT02939391|Drug|Placebo|Oral administration
15993363|NCT02939378|Dietary Supplement|Ketogenic diet|Ketogenic diet adjuvant to salvage chemotherapy is given to recurrent glioblastomas.
15993364|NCT02939378|Dietary Supplement|Standard diet|Standard diet adjuvant to salvage chemotherapy is given to recurrent glioblastomas.
15993365|NCT02939365|Drug|Belatacept|The transition to belatacept monotherapy and possibly to q 8 weeks administration can be safely done by applying personalized (i.e. precision) medicine. This includes phenotypic analysis of lymphocyte subsets, a quiescent molecular profiling of blood and urine prior to drug withdrawal and immune monitoring with KSORT after stepwise withdrawal of steroids and antiproliferatives. Furthermore, trough PK of belatacept will be measured for conversion to q 8 week therapy for discovering research purposes.
15993366|NCT02939352|Device|Real continuous Theta Burst Stimulation|Continuous Theta Burst stimulation delivered
15993367|NCT02939352|Device|Sham continuous Theta Burst Stimulation|active sham Continuous Theta Burst stimulation delivered
15993368|NCT02939339|Device|continuous theta burst stimulation (real)|a form of transcranial magnetic stimulation that noninvasively induces a depression in brain reactivity
15993369|NCT02939339|Device|continuous theta burst stimulation (sham)|a sham version of a form of transcranial magnetic stimulation that noninvasively induces a depression in brain reactivity
15993370|NCT02939326|Drug|EB-001 injection|
15993371|NCT02939326|Drug|Placebo injection|
15993372|NCT02939313|Device|medial prefrontal cortex|a form of theta burst stimulation that noninvasively induces a depression in brain reactivity
15993373|NCT02939313|Device|dorsolateral prefrontal cortex|a form of transcranial magnetic stimulation that noninvasively induces an increase in brain reactivity
15993374|NCT02939313|Device|sham|sham stimulation
15993375|NCT02939300|Drug|Nivolumab|
15993376|NCT02939300|Drug|Ipilimumab|
15993377|NCT02939287|Drug|Aprepitant|Add aprepitant to anti-emetic regimen
15993378|NCT02939287|Drug|Olanzapine|add olanzapine to anti-emetic regimen
15993379|NCT02939287|Drug|Aprepitant plus Olanzapine|add aprepitant and olanzapine to anti-emetic regimen
15993380|NCT02939274|Drug|Verteporfin|
15993425|NCT02938949|Drug|placebo|
15993381|NCT02939274|Device|Continuous Low-Irradiance Photodynamic Therapy (CLIPT)|
15993382|NCT02939261|Behavioral|Intervention - 4 Home Visits|4 home visits from a health educator, weekly e-mails, and monthly mailed behavioural supports.
15993383|NCT02939261|Behavioral|Control|monthly emails with general health information
15993384|NCT02939248|Drug|Crushed ticagrelor followed by morphine|Crushed ticagrelor (180 mg) followed by morphine 5 mg intravenously
15993385|NCT02939248|Drug|Crushed ticagrelor, morphine,naloxone|Crushed ticagrelor (180 mg) orally followed by morphine 5 mg intravenously and naloxone 1 mg orally
15993386|NCT02939235|Drug|Crushed ticagrelor followed by morphine|Crushed ticagrelor (180 mg) followed by morphine 5 mg intravenously
15993387|NCT02939235|Drug|Crushed ticagrelor, morphine,metoclopramide|Crushed ticagrelor (180 mg) orally followed by morphine 5 mg and metoclopramide 10 mg intravenously
15993388|NCT02939222|Device|Implant placement|Routine implant placement in the ideal three dimensional implant position
15993389|NCT02939209|Drug|Hydromorphone Hcl 2Mg Tab|Patients will be given 2 mg hydromorphone (immediate release formulation) in the post anesthetic care unit.
15993390|NCT02939209|Drug|Placebo|Patients may be randomized to placebo.
15993391|NCT02939196|Procedure|office hysteroscopy 3.7|office hysteroscopy with a 3.7 -mm outer sheath
15993392|NCT02939196|Procedure|office hysteroscopy 4|office hysteroscopy with a4-mm outer sheath
15993393|NCT02939183|Drug|Immediate Release (IR) Formulation|Immediate Release (IR) Formulation
15993394|NCT02939183|Drug|Gastro-Retentive (GR) Formulation|Gastro-Retentive (GR) Formulation
15993395|NCT02939183|Drug|Dexamethasone|Dexamethasone
15993396|NCT02939183|Drug|Pomalidomide|Pomalidomide
15993397|NCT02939170|Device|Delefilcon A Multifocal Contact Lenses with Molded Mark|
15993398|NCT02939170|Device|Delefilcon A Multifocal Contact Lenses|
15993399|NCT02939157|Other|Cardiac diagnostic ultrasound|Point-of-care ultrasound for diagnosing heart failure in primary care patients
15993400|NCT02939144|Dietary Supplement|Liquorice|Liquorice ingestion will mimic the inherited condition of 'Apparent mineralocorticoid excess (AME)by showing the effects of the reduced activity of 11ßHSD-2 (which leads to an accumulation of cortisol which binds MR and hence has the effect of aldosterone).
15993401|NCT02939131|Behavioral|Health and Wellness Combined Cognitive Behavioral Therapy and a Medication Management Algorithm|Behavioral therapy based on a manualized approach developed specifically for youth living with both HIV and depression, using problem-solving, motivational interviewing and cognitive-behavioral strategies to decrease adherence obstacles and increase wellness. The medication management algorithm includes guidance for clinicians on strategies and tactics to treat depression in this population, including factors to consider when deciding on treatments (i.e., drug-drug interactions, side effects).
15993402|NCT02939131|Behavioral|Enhanced Standard of Care|Ongoing psychopharmacological and psychosocial counseling and treatment for depression at HIV clinical treatment centers enhanced by providing clinicians with up-to-date information and didactic training on current principles for use of medication and psychotherapy in the treatment of depression.
15993403|NCT02939105|Device|The ZELTIQ CoolSculpting System|The CoolSculpting device will be used to perform treatments.
15993404|NCT02939092|Drug|Pomegranates peel extract|Pomegranate is antimicrobial
15993405|NCT02939092|Drug|Chlorhexidine|Chlorhexidine mouthwash is antiplaque agent
15993406|NCT02939079|Drug|Fingolimod|Produced by Osveh ® Pharm Company in Iran
15993407|NCT02939079|Dietary Supplement|Fish Oil|produced by Zahravi ® Pharm Company in Iran
15993408|NCT02939079|Drug|Placebo (for Fish Oil)|placebo capsules to mimic Fish Oil 1 g capsules
15993409|NCT02939053|Device|SOZO|The SOZO device is a bioimpedance spectroscopy device that measures bioimpedance parameters.
15993410|NCT02939040|Behavioral|Positive Activities|"The PPB intervention involves noting at least one positive event each day, writing it down on a slip of paper and then depositing this piece of paper in a piggy bank. This practice is to take place at the end of the day, every day over a circumscribed period of time. At the end of the deposit period the participant closes the account and makes a full withdrawal by taking all of the slips out of the piggy bank and reading each one the night before surgery."
15993411|NCT02939027|Device|Electronic Brachytherapy (6,1 Gy)|A total dose of 36.6 Gy is planned over 6 fractions of 6.1 Gy, given 2 days/week, during 3 weeks or lees, at least 2 days apart each fraction.
15993412|NCT02939027|Device|Electronic Brachytherapy (7 Gy)|A total a dose of 42 Gy is planned over 6 fractions of 7 Gy, given 2 days/week during 3 weeks or lees, at least 2 days apart each fraction.
15993413|NCT02939014|Drug|Brentuximab Vedotin|Brentuximab vedotin IV infusion
15993414|NCT02939001|Device|iris recognition scanner|
15993415|NCT02938988|Procedure|Antimicrobial photodynamic therapy|Described in arm/group
15993416|NCT02938988|Procedure|Scaling and root planning|Described in arm/group
15993417|NCT02938988|Device|red laser|658nm; 0.1W; 2229J/cm², 10s per point
15993418|NCT02938988|Drug|methylene blue dye|
15993419|NCT02938975|Other|Ultra 30 Insect Repellent Lotion (30% Lipo DEET)|"One application of Lipo DEET protects for up to 12 hours and has a pleasant odour and non-greasy feel on the skin. DEET is a broad spectrum insect repellent and was selected this study because it has been extensively tested for safety and toxicity for human use and its efficacy against a broad variety of arthropod vectors. DEET was first registered in 1957 and has been conclusively proven to be safe for use on adults, children, pregnant and lactating mothers.
~This Liposome-based repellent is the newest advancement in insect repellent technology. The Liposome envelops the active ingredient, DEET, and slowly time-releases it as needed, thereby extending the effectiveness of the repellent and reducing dermal absorption."
15993420|NCT02938975|Other|Permethrin Factory-Treated Army Combat Uniforms|Permethrin is the U.S., Australian and United Kingdom (UK) military's standard repellent for application to fabric and is considered the most effective clothing treatment available to prevent insect bites through fabric. The Army objective is to provide 90% bite protection for at least 50 launderings; an objective easily met through factory treatment of uniforms, which demonstrates 99-100% bite protection up to 50 launderings (the expected lifetime of the uniform).
15993421|NCT02938975|Other|Placebo lotion|A liposome lotion with no DEET
15993422|NCT02938975|Other|Army combat uniform|Army combat uniform with no permethrin
15993423|NCT02938962|Drug|Tranexamic Acid|
15993426|NCT02938936|Other|Pre-natal visit scheduling|This intervention will include a scheduled date and time for prenatal care follow-up visits. Women in the intervention group seeking care for their first ANC appointment will be offered several appointment slots on their return date by the nurse providing their first ANC visit. Women will be able select among the time options and will be provided an appointment card with their scheduled date and time. Staff will limit the number of scheduled women per hour by maintaining an appointment book. Clinic staff will be trained to differentiate between women returning for a scheduled visit from first prenatal visits, emergencies, and unscheduled return visits. First visits and emergencies will be seen during the first 2 hours after clinic opening and unscheduled women will be seen during a one-hour time slot midday. When women return on their date, they will be seen within one hour of their appointment time by clinic staff.
15993427|NCT02938923|Drug|Testosterone|Topical testosterone gel 1%
15993428|NCT02938923|Drug|Placebo gel|Inactive skin gel
15993429|NCT02938923|Behavioral|Supervised exercise training|Multicomponent exercise program focused primarily on progressive resistance exercise training
15993430|NCT02938923|Behavioral|Home exercise program|Flexibility exercises performed at home 3 times per week and reviewed by study staff once a month.
15993431|NCT02938923|Behavioral|Health Education Modules|30-40 minute presentations conducted by study staff for participants focused on health concerns unrelated to exercise.
15993432|NCT02938910|Other|non interventional study|Non invasive imaging study without interventional procedures
15993433|NCT02938897|Behavioral|Registered Dietitian Nutritionist (RDN) Support|RDN provided individualized medical nutrition therapy via videoconference at weeks 1, 5, and 9 and telephonic nutrition coaching support at weeks 2-4, 6-8, and 10-12.
15993434|NCT02938897|Behavioral|Diet-related educational materials|Individualized caloric recommendations (500-750 kcal reduction) were made and food-based educational materials emphasizing general healthful eating patterns and increased intakes of nutrient-rich foods were provided.
15993435|NCT02938897|Behavioral|Self-monitoring tools|Self-monitoring tools including: weekly weight log, fruit and vegetable tracker, and a SMART (specific, measurable, achievable, relevant, and time bound) goal planner were provided.
15993436|NCT02938884|Device|HidrateSpark Water Bottle|HidrateSpark water bottle is a smart water bottle that glow when its time to drink water. It is run through an app on a smart phone
15993437|NCT02938871|Dietary Supplement|Synbiotic|The patients of this group will receive 6 grams of synbiotic composition, to be administered via feeding tube or orally, twice time a day, for 15 consecutive days.
15993438|NCT02938871|Dietary Supplement|Control|The patients of this group will receive 6 grams of maltodextrin, to be administered via feeding tube or orally, twice time a day, for 15 consecutive days.
15993439|NCT02938845|Behavioral|Spielberger's State-Trait Anxiety Inventory(STAI )|State anxiety (STAI-S) refers to a temporary emotional state related to a specific situation, whereas trait anxiety (STAI-T) represents anxiety as a relatively stable personality character. Each scale has values ranging from 20 to 80, with higher scores representing more severe anxiety. The STAI has no established categories, but a cutoff score of 40 has been used to identify patients with high/very high anxiety. The validity and reliability of the Turkish versions of these instruments have been validated.
15993440|NCT02938845|Procedure|total laparoscopic hysterectomy(TLH)|
15993441|NCT02938845|Procedure|total abdominal hysterectomy(TAH)|
15993442|NCT02938832|Behavioral|Advice on what food to choose and eat|Dietary advice
15993443|NCT02938819|Other|Goal-oriented upper-limb intervention|The Goal-oriented upper-limb intervention evaluated patients' expectations and the environmental factors influencing the performance of the specific task were identified for each of the three tasks. Patients were asked to perform the activity at home. After this, the observable target behavior corresponding to the target activity was determined. Then, an occupational and a physical therapist worked together with the patient to identify the assistance required to perform this activity such as human assistance, technical aids, assistive devices or verbal guidance.
15993444|NCT02938819|Other|Standard upper limb intervention|The standard upper limb intervention involved active upper limb range of motion, manual dexterity involving grasp and manipulation of small pieces such as marbles and stretching upper limb exercises.
15993445|NCT02938806|Other|No intervention|No intervention
15993446|NCT02938793|Drug|Durvalumab|intravenous administration
15993447|NCT02938793|Drug|Tremelimumab|intravenous administration
15993448|NCT02938780|Other|placebo text message|The subjects in the control group will receive placebo text messages which will be timed as the intervention group that are unrelated to the study or topics of exercise and nutrition.
15993449|NCT02938780|Other|nutrition physical activity text message|The subjects in the intervention group will receive text messages with nutrition and physical activity-related information throughout the study period on a daily basis, varying text message arrival over a 10 am to 7 pm time frame. The American Cancer Society recommends a set of exercise and nutrition behaviors for cancer survivors based upon developed expert evidence. These behaviors have been structured to achieve healthier lifestyles, improve quality of life and reduced mortality. The intervention will provide via text messaging exemplars and social norms designed to improve compliance with this advice.
15993450|NCT02938754|Behavioral|VR-based motor training|Subjects will perform 3 different training protocols in Virtual Reality that imply performing tasks of vertical and planar reaching and hitting spheres, or hockey pucks, spaced at different time, speed and color.
15993451|NCT02938754|Behavioral|Conventional Therapy|Subjects will perform conventional rehabilitation tasks for the upper-extremities that imply vertical and planar reaching movements.
15993452|NCT02938741|Drug|Anti-human Thymoglobulin|r-ATG 2.5MG/KG*4days were used in the conditioning
15993453|NCT02938741|Drug|Placebo|r-ATG 2.5MG/KG*4days were not used in the conditioning
15993454|NCT02938728|Other|Biopsies|
15993455|NCT02938715|Other|teledermatology feedback|subject provided feedback to continue or discontinue their cream (based on actinic keratoses grading and lesion counting)
15993456|NCT02938689|Other|Exercise|
15993478|NCT02938520|Drug|DTG Tablet|"It is a yellow, round, biconvex, 50 mg film-coated tablet debossed with SV 572 on one side and 50 on the other side. Each tablet of DTG also contains the following inactive ingredients: D-mannitol, microcrystalline cellulose, povidone K29/32, sodium starch glycolate, and sodium stearyl fumarate."
15993479|NCT02938507|Drug|Formulation 1 solabegron|
15993480|NCT02938507|Drug|Formulation 2 solabegron|
15993457|NCT02938663|Behavioral|Questionnaires and Measurements|Participants completed anthropometric measurements and questionnaires assessing psychosocial stress, habitual dietary intake and physical activity as well as cultural identity, identity-based motivation and socioeconomic status. At home, participants recorded their habitual physical activity and food intake. Participants then returned to the laboratory to complete an assessment of identity-based motivation and received personalized information regarding their habitual physical activity and dietary patterns.
15993458|NCT02938650|Drug|Nitrosomonas eutropha|Subjects will get nitrosomonas eutropha to apply for one week. There is only one arm to this study. Subjects will apply the medication twice a day for one week.
15993459|NCT02938624|Drug|Pembrolizumab 200 mg IV single dose|Pembrolizumab 200 mg IV single dose, 21 days later surgery
15993460|NCT02938624|Drug|Pembrolizumab 200 mg IV twice interval 21 days|Pembrolizumab 200 mg IV twice interval 21 days, 21 days later surgery
15993461|NCT02938624|Drug|Pembrolizumab 200 mg IV Twice interval 21d,surgery after 10d|Pembrolizumab 200 mg IV Twice interval 21d,surgery after 10d
15993462|NCT02938624|Drug|Pembrolizumab 100 mg I.V single dose|Pembrolizumab 100 mg I.V single dose, surgery after 21 days.
15993463|NCT02938624|Procedure|Surgical resection of tumor|Surgical resection of tumor by any of the acceptable procedures
15993464|NCT02938598|Behavioral|Maternal Depression Education and Care-Seeking Motivation|Multicomponent behavioral and educational intervention. The investigators are only testing 3 components: Engagement, Problem-Solving, and Follow-Up Motivation
15993465|NCT02938585|Drug|turoctocog alfa|The preventative treatment is administered intravenously (i.v.) at specific intervals either every second day or three times a week. Bleeding treatment will be administered if a bleed should occur.
15993466|NCT02938585|Drug|turoctocog alfa|Treatment is administered intravenously (i.v.) during bleeds and occasionally as a preventative treatment (e.g. before physical activity)
15993467|NCT02938572|Drug|NNC0143-0406|Administered subcutaneously (s.c. under the skin)
15993468|NCT02938572|Drug|Insulin Aspart|Administered subcutaneously (s.c. under the skin)
15993469|NCT02938559|Behavioral|Cognitive Therapy (CT) for depression|There is evidence that CT for major depressive disorder (MDD) can be as effective as antidepressant medication for the initial treatment of moderate to severe MDD. Moreover, following the withdrawal of treatment, patients treated with CT are significantly less likely to relapse than patients treated with antidepressant medication and CT is at least as effective as antidepressant medication in preventing subsequent relapse. CT aims to alter the symptomatic expression of depression and reduce risk for subsequent episodes by correcting the negative beliefs and maladaptive information processing presumed to underlie the disorder and alter the systematic tendency to misperceive reality in a pessimistic fashion.
15993470|NCT02938559|Behavioral|Cognitive Therapy (CT) for depression + Memory Support|The Memory Support Intervention will be delivered interwoven with CT. The Memory Support Intervention is designed to improve patient memory for treatment and involves a series of specific procedures that support the encoding and retrieval stages of episodic memory. It is comprised of eight memory promoting strategies: attention recruitment, categorization, evaluation, application, repetition, practice remembering, cued-based reminder and praise recall. These strategies are proactively, strategically and intensively integrated into treatment-as-usual to support encoding. Memory support is delivered alongside each 'treatment point', defined as a main idea, principle, or experience that the treatment provider wants the patient to remember or implement as part of the treatment.
15993471|NCT02938546|Radiation|18F-FDG|18FDG-PET scan was performed 4 weeks before the first administration of therapy or before the third cycle chemotherapy or before the 7th week of targeted therapy and after 3 days chemotherapy and targeted therapy. The lesions were analyzed by nuclear medicine physician and calculate the metabolism response. The size of percent changes was evaluated using the EORTC (European Organization for Research and Treatment of Cancer) PET criteria by oncologist who determine whether the scheme works and the scheme should continue or change. The seleted patients were double blinded to analyse the relationship between metabolism response and chemotherapy response.
15993472|NCT02938533|Behavioral|Intervention|The intervention includes a clinic-based component and a take-home component. All components include the priming image of a Baobab tree. The clinic-based component is an interactive poster that rewarded appointment attendance. Patients who attend three consecutive on-time visits are congratulated and given a colored sticker to place on a poster that is publicly displayed at the clinic. In one clinic, the take-home component is a 2015 calendar in Kiswahili that contained the priming Baobab image. In the other clinic, the take-home component is a small plastic pillbox featuring the Baobab logo.
15993473|NCT02938520|Drug|Cabotegravir (CAB) tablet|It is a white oval shaped film coated 30 mg tablets for oral administration. CAB Tablet is composed of cabotegravir sodium, lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycolate, magnesium stearate, and white film-coat.
15993474|NCT02938520|Drug|Rilpivirine (RPV) tablet|"It is a 25 mg tablet with off-white, round, biconvex, film-coated and debossed on one side with TMC and the other side with 25. Each tablet contains RPV hydrochloride, and the inactive ingredients croscarmellose sodium, lactose monohydrate, magnesium stearate, polysorbate 20, povidone K30 and silicified microcrystalline cellulose."
15993475|NCT02938520|Drug|Cabotegravir - Injectable Suspension (CAB LA)|It is a sterile white to slightly pink suspension containing 200 mg/mL of CAB as free acid for administration by intramuscular (IM) injection. Each vial is for single-dose use containing a withdrawable volume of 2.0 mL, and does not require dilution prior to administration. CAB LA is composed of cabotegravir free acid, polysorbate 20, polyethylene glycol 3350, mannitol, and water for injection.
15993476|NCT02938520|Drug|Rilpivirine - Injectable Suspension (RPV LA)|It is a sterile white suspension containing 300 mg/mL of RPV as the free base. The route of administration is by intramuscular (IM) injection. Each vial contains a nominal fill of 2.0 mL, and does not require dilution prior to administration. RPV LA requires refrigeration and must be protected from light. RPV LA is composed of RPV free base, poloxamer 338, sodium dihydrogen phosphate monohydrate, citric acid monohydrate, glucose monohydrate, sodium hydroxide, water for injection.
15993477|NCT02938520|Drug|ABC/DTG/3TC STR - Tablet|"It is a purple, biconvex, oval, tablet debossed with 572 Tri on one side, film-coated tablet contains abacavir sulphate equivalent to 600 mg of abacavir, dolutegravir sodium equivalent to 50 mg dolutegravir, and 300 mg of lamivudine. The inactive ABC/DTG/3TC tablet ingredients include D-mannitol, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate."
15993481|NCT02938494|Drug|IDP-123 Lotion|Lotion
15993486|NCT02938468|Procedure|Any surgical intervention aim at treating chronic subdural hematoma|
15993487|NCT02938442|Biological|P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel|Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period in combination with standard neoadjuvant chemotherapy.
15993488|NCT02938442|Drug|Doxorubicin + Cyclophosphamide + Paclitaxel|Eligible subjects will be enrolled and receive standard neoadjuvant chemotherapy alone
15993489|NCT02938429|Other|Physical activity measures via Actigraph GT3X+ accelerometers for 7 consecutive days|
15993490|NCT02938416|Device|Isokinetic strengthening exercise|Isokinetic strengthening exercise provides muscle training throughout the range of motion of a joint at a pre-set constant speed of angular velocity. It can be performed in an eccentric or concentric way in a controlled manner, and is evidenced to be an effective and safe training method in patients with anterior cruciate ligament reconstruction, burn injury, ankle instability, osteoarthritic knee, and chronic stroke in the past literatures.
15993491|NCT02938416|Device|Isotonic strengthening exercise|Isotonic strengthening exercise keeps the tension remained unchanged during the muscle's length changing. As the muscle's force changes via the length-tension relationship during a contraction, an isotonic contraction will keep force constant while velocity changes. There are two types of isotonic contractions: (1) concentric and (2) eccentric. In a concentric contraction, the muscle tension rises to meet the resistance, then remains the same as the muscle shortens. In eccentric, the muscle lengthens due to the resistance being greater than the force the muscle is producing.
15993492|NCT02938403|Behavioral|In vivo counseling|Participants in the intervention group will receive 4 in session nicotine replacement therapy and counseling focused on their experience of using NRT, including positive experiences, side effects and smoking cessation expectancies. They will also received nicotine replacement therapy (nicotine lozenge and patch) to use for smoking cessation.
15993493|NCT02938403|Behavioral|Standard Smoking Cessation Counseling|Participants will receive 4 sessions of standard behavioral counseling to address their smoking. In addition, participants will received nicotine replacement therapy (Nicotine lozenge and patch) to use for smoking cessation.
15993494|NCT02938390|Procedure|Ultrasound for localizing intercostal perforating vessels|Use of an Intra-operative ultrasound during nipple sparing mastectomy to localize intercostal perforating vessels.
15993495|NCT02938377|Behavioral|Computerized Brief Intervention (CBI)|A video which emphasizes personal responsibility for change, uses empathy as a counseling style, and enhances self-efficacy. Depending on alcohol dependence level, four different CBI versions may be shown over two visits.
15993496|NCT02938377|Behavioral|CBT4CBT|9 computerized modules delivered at the participant's pace
15993497|NCT02938377|Drug|Recommendation and Counseling for Alcohol Pharmacotherapy|The APT algorithm will utilize the four FDA approved APTs for the treatment of alcohol use disorder. The treatment of the patient is part of routine care.
15993498|NCT02938364|Other|Earplugs|Plastic earplugs on both ears
15993499|NCT02938364|Other|Acupressure|Sea Bands put on the wrists of the participant to apply pressure on P6 points
15993500|NCT02938364|Other|Placebo|Non pressure bands put on the wrists of the participant
15993501|NCT02938351|Behavioral|Collaborative care|Therapist will use iPad (Vidyo) once a week during dialysis for approximately one hour. The therapist will teach the patient cognitive-behavioral strategies to manage their mood and pain. The PI is a clinical psychologist and will provide supervision to the therapist providing the intervention. The sessions for depression will include (1) intake, (2) review of the rational for using CBT to treat depression and/or pain, (3) identifying thought patterns, (4) changing thought patterns, (5) relaxation techniques, (6) rest-activity pacing, and (7) coping strategies. Homework to practice these techniques will be provided after each session.
15993502|NCT02938338|Procedure|Bariatric surgery|Bariatric surgery, with an anticipated mean weight loss of 30 kg
15993503|NCT02938312|Behavioral|Weight Loss Only|Participants will attend in-person weekly sessions (about 1.5 hours each) for 6 months and then twice a month for 3 months and monthly for 3 months. Sessions focus on behavioral techniques supporting healthy diet (including calorie restriction for weight loss) and achieving recommended amounts of physical activity per week. During 1-year weight loss maintenance, participants receive monthly motivational phone calls.
15993504|NCT02938312|Behavioral|Weight Loss Plus|Participants attend in-person meetings as described above. This condition also includes community-wide strategies to increase access to healthy affordable food and safe opportunities for physical activity.
15993505|NCT02938299|Drug|L19IL2 + L19TNF|Mixture of L19IL2 and L19TNF once weekly
15993506|NCT02938299|Procedure|Surgery|Surgical resection of melanoma tumor lesions
15993507|NCT02938286|Device|Fractional CO2 laser, 2.5 mJ, 5% density|Pretreatment at 2.5 mJ/microbeam and 5% density. Pain stimulus at 50 mJ/microbeam and 5% density
15993508|NCT02938286|Device|Fractional CO2 laser, 2.5 mJ, 15% density|Pretreatment at 2.5 mJ/microbeam and 15% density. Pain stimulus at 50 mJ/microbeam and 5% density
15993509|NCT02938286|Device|Fractional Er:YAG laser, 9 mJ, 5% density|Pretreatment at 9 mJ and 5% density.
15993510|NCT02938286|Device|Fractional Er:YAG laser, 9 mJ, 15% density|Pretreatment at 9 mJ and 15% density.
15993511|NCT02938286|Device|Fractional CO2 laser, 50 mJ, 5% density|Pain stimulus at 50 mJ/microbeam and 5% density
15993512|NCT02938286|Drug|AHES|Topical application at test region I-IV under occlusion for 15 minutes
15993513|NCT02938273|Drug|avelumab|Avelumab10 mg/kg i.v. at day -7, 7, 21,35 + maintenance therapy i.e avelumab10 mg/kg i.v. every 2 weeks for 6 months
15993514|NCT02938273|Radiation|radiotherapy|5 times a week, 7 weeks, total dose 70 Gy
15993515|NCT02938273|Drug|cetuximab|loading dose 400 mg/m2 i.v. day -7, 250 mg/m2 i.v weekly wk 1-7
15993516|NCT02938260|Drug|Metoprolol vs Diltiazem|
15993517|NCT02938247|Dietary Supplement|High caloric, high protein ONS|
15993518|NCT02938234|Dietary Supplement|High caloric, high protein ONS|
15993519|NCT02938221|Device|Telemedical video-oculography system|Telemedical video-oculography setup consisting of video goggles (EyeSeeCam, Interacoustics GmbH, Germany), a mobile telemedical workstation and an extended conferencing and remote control system (MEYTEC GmbH, Germany)
15993520|NCT02938208|Device|Jupiter Full Face Mask|Full Face Mask for the treatment of obstructive sleep apnea (OSA) using CPAP therapy.
15994709|NCT02929485|Drug|Tolcapone|Tolcapone 200mg (single dose) administered at study visit
15993521|NCT02938195|Radiation|radiotherapy|The clinical target volume of radiotherapy only includes the visible tumor and lymph nodes and the investigators wouldn't do any prophylactic radiation treatment.
15993522|NCT02938195|Procedure|Surgery|Surgery would be done 4-8 weeks after neoadjuvant chemoradiotherapy.
15993523|NCT02938182|Drug|clopidogrel|clopidogrel troche 75 mg daily for three months
15993524|NCT02938169|Behavioral|exercise|"stabilization exercise: Lumbar stabilization is a multi-component program and involves education/training, strength, flexibility, and endurance. It is generally used during all phases of a back pain episode and may be prescribed after a thorough evaluation of the patient's specific condition.
~bracing exercise: patient is instructed as follows: Draw your navel up towards your head and in toward your spine without moving your pelvis. Continue to breathe normally as you do this.
~walking exercise: treadmill gait with tolerable gait speed
~flexibility exercise: stretching exercise(control)"
15993525|NCT02938143|Procedure|Exercise|The intervention treatment is a progressive 4-stage criteria-based exercise protocol within the limits of pain, consisting of progressive isometric, isotonic, plyometric, and sport-specific exercises.24 Progression criteria are individualized.
15993526|NCT02938143|Procedure|Exercise (usual care)|The control treatment is a painful heavy-load eccentric exercise program performed twice daily with 3 sets of 15 repetitions for 12 weeks on a 25° decline board. The downward component (eccentric component) will be performed with the symptomatic leg and the upward component (concentric phase) on the asymptomatic leg.
15993527|NCT02938130|Other|Wellness Programs|Wellness Programs delivered in the Community Partners and Community LIFE programs
15993528|NCT02938117|Other|cycling exercises|
15993529|NCT02938104|Dietary Supplement|Whey Protein Isolate Powder|"Nutritional counselling is given to patients to ensure their daily proteins and energy requirements are met. Whey Protein Isolate Posder (Immunocal) is provided.
~Immunocal (1.5g/kg PO (by mouth) per day in daily doses"
15993530|NCT02938104|Behavioral|Physical Exercise Program|Physical exercises personalized by a kinesiologist consisting of walking or stationary bike and elastic band exercises.
15993531|NCT02938104|Behavioral|Relaxation Techniques|Relaxation techniques consisting of breathing exercises and using a relaxation CD
15993532|NCT02938091|Other|High-fat diet|Typical Western diet
15993533|NCT02938091|Other|Low-fat diet|Traditional Caribbean Hispanic diet
15993534|NCT02938078|Device|Avenova Lid Cleanser|Avenova lid cleanser is an FDA-cleared saline solution preserved with 0.01% pure hypochlorous acid.
15993535|NCT02938065|Procedure|Ultrasound|Baseline ultrasound is performed upon arrival. Ultrasound is performed when beverage is consumed and then every 30 minutes thereafter until stomach is empty.
15993536|NCT02938065|Other|2% milk|16 participants will drink 10 ounces of 2% milk
15993537|NCT02938065|Other|apple juice|16 participants will drink 10 ounces of apple juice
15993538|NCT02938065|Other|ensure clear|16 participants will drink 10 ounces of ensure clear
15993539|NCT02938052|Behavioral|PP-based health behavior intervention|The positive psychology exercises include 3 modules: Gratitude-based activities, Strength-based activities, and Meaning-based activities. The goal setting exercises include 3 modules: Physical activity, Heart-healthy diet, and Medication adherence.
15993540|NCT02938039|Device|Ambu LMA|Ambu Laryngeal Mask Airways
15993541|NCT02938039|Device|I-Gel LMA|I-Gel Laryngeal Mask Airways
15993542|NCT02938026|Procedure|Bariatric surgery|
15993543|NCT02938026|Behavioral|Telephone Intensive Lifestyle Counselling|
15993544|NCT02938013|Drug|Sofosbuvir/Velpatasvir/Voxilaprevir [SOF/VEL/VOX]|antiviral therapy for HCV
15993545|NCT02938013|Drug|Sofosbuvir/Velpatasvir (SOF/VEL)|antiviral therapy for HCV
15993546|NCT02938000|Device|Theraband with exercise video|Theraband exercise band for resistance training
15993547|NCT02938000|Other|usual care with advice to exercise|advice to exercise
15993548|NCT02937974|Drug|Xuebijing|Xuebijing injection 50ml in 100ml of Normal Saline IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days
15993549|NCT02937974|Drug|Placebo|Normal Saline 150ml IV, in 80mins, per 12 hours. administration of the agent for consecutive 5 days
15993550|NCT02937961|Biological|Early SLED|withing 6 to 12 hours
15993551|NCT02937961|Biological|Late SLED|when absolute indications will meet
15993552|NCT02937948|Other|Adaptative treatment plan|"Each patient will have 3 scanners before treatment initiation. One corresponding to an empty bladder, one to an intermediate one, one to a full bladder."
15993553|NCT02937948|Radiation|External radiotherapy|At the time of each fraction of external radiotherapy, the most appropriate plan (empty, intermediate, full bladder) covering the target and sparing the organs at risk is chosen.
15993554|NCT02937935|Biological|Protocol Guided Renal Replacement Therapy|In the on-demand group patients would get dialysis only when patient fulfills absolute criteria requiring dialysis such as metabolic acidosis with ph<7.2, hyperkalemia, refractory fluid overload (non-responsive to diuretics) or oliguria with urine output of less than 0.5ml/kg for more than 24-48 hours from the time of randomization.
15993555|NCT02937935|Biological|On Demand Renal Replacement Therapy|Patients to be randomized to the intervention as per standard of care
15993556|NCT02937922|Other|AEROBIC|The aerobic exercise session (AE) will consist of 40 minutes on an exercise bike in heart rate (HR) corresponding to 60% of heart rate reserve (moderate intensity) acquired by the formula of Karvonen: [(HR max - HR rest) x desired intensity] + HR rest; monitored through heart monitor brand Polar and perceived exertion rating (Borg scale of 6-20). It will be added to the exercise time 5-7 minutes to proper heating.
15993557|NCT02937922|Other|RESISTANCE|The resistance exercise session (RE) will last 40 minutes and will consist in carrying out 4 sets of 12 repetitions with interval of 90 seconds between sets and exercises. The weight will be adjusted to 60 % of a maximum repetition (1-RM) (moderate intensity) in four exercise for the lower limbs: leg press, knee extension, bend knees and plantar flexion (calf). The cadence of each series will be controlled by electronic metronome and performed with 2 seconds in the concentric phase and 2 seconds in the eccentric phase. It will be added to the exercise time 5-7 minutes for the warming to be held in the leg press exercise (one set of 15 to 20 repetitions with 1/3 load set for the session).
15993600|NCT02937623|Device|Dissolvable polymer strip containing Novamin (calcium sodium phosphosilicate)|Experimental dissolvable polymer strip containing Novamin (15% weight by weight[w/w] calcium sodium phosphosilicate).
16011751|NCT02799134|Drug|Vitamin C|
15993558|NCT02937922|Other|COMBINED|The combined exercise session (resistance and aerobic) will last 40 minutes. The exercise resistance phase of the combined session will consist of 20 minutes, according to the resistance exercise described above. Immediately after resistance exercise, patients will perform aerobic exercise (AE) for 20 minutes. In order to keep the equivalent time among the three interventions (aerobic exercise, resistance and combined) will be performed two series (2 x 12 repetitions) in each resistance exercise.
15993559|NCT02937909|Other|Use of wound care products from a single manufacturer|The participating Healthcare Professionals will be asked to use BSN medical wound care products for the study duration
15993560|NCT02937896|Drug|Desmopressin|40 micrograms Nasal Desmopressin.
15993561|NCT02937896|Drug|Ketorolac|30mg intravenous Ketorolac.
15993562|NCT02937896|Drug|Normal Saline|1cc intravenous Normal Saline.
15993563|NCT02937896|Drug|Normal Saline|4 puffs nasal Normal Saline.
15993564|NCT02937883|Other|Empowerment intervention|Empowerment intervention for persons with young onset dementia
15993565|NCT02937870|Device|Test Product 1|Test adhesive 1 with a thin nozzle
15993566|NCT02937870|Device|Test Product 2|Test adhesive 2 with a thin nozzle
15993567|NCT02937870|Device|Reference Product|Adhesive Cream
15993568|NCT02937870|Other|Negative Control|No adhesive
15993569|NCT02937857|Drug|Standard treatment only|standard treatment， such as antiasthmatic,expectorant,antipyretic
15993570|NCT02937857|Drug|Standard treatment+Xiyanping injection|standard treatment+Xiyanping injection:standard treatment， such as antiasthmatic, expectorant and antipyretic plus Xiyanping injection,0.2-0.4mL/kg/day,qd for 5 days.
15993571|NCT02937844|Biological|Anti-PD-L1 CSR T cells|Prescribed CSR T cells are infused intravenously to patients in a three-day split-dose regimen（day0,10%; day1, 30%; day2, 60%）.
15993572|NCT02937844|Drug|Cyclophosphamide|250 mg/m^2, d1-3
15993573|NCT02937844|Drug|Fludarabine|25mg/m^2, d1-3
15993574|NCT02937831|Biological|RIXUBIS|
15993575|NCT02937818|Drug|Durvalumab and Tremelimumab|Durvalumab + tremelimumab via intravenous (IV) infusion every 4 weeks (q4w), starting on Week 0, for up to a total of 4 months (4 cycles) followed by durvalumab monotherapy via IV infusion q4w, starting on Week 16 until PD, or for other discontinuation criteria.
15993576|NCT02937818|Drug|AZD1775 and carboplatin (CBPT)|AZD1775 twice daily (oral) for 2.5 days from Day 1 + CBDP area under the curve 5 (Day1) (IV); every 3 weeks.
15993577|NCT02937818|Drug|AZD6738 and olaparib|AZD6738 once a day (oral) for 7 days from Day 1 + olaparib twice a day(oral) for 28 days from Day 1, every 4 weeks
15993578|NCT02937805|Device|Moisturizing vaginal and vulvar sea buckthorn oil cream|
15993579|NCT02937805|Device|Moisturizing vaginal and vulvar cream|
15993580|NCT02937792|Drug|intrathecal 15 mg bupivacaine|spinal anesthesia with a large dose of bupivacaine 0.5% in elective caesarean section
15993581|NCT02937779|Drug|Tenofovir disoproxil fumarate|tenofovir disoproxil fumarate 300 mg one tablet once daily from 24 weeks of amennorrhea to 6 weeks post-partum for HBe Ag positive women only.
15993582|NCT02937779|Device|Rapid tests HBe Ag|For all HBs Ag positive women
15993583|NCT02937766|Drug|Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)|
15993584|NCT02937766|Drug|Makena® (Hydroxyprogesterone Caproate Injection, 250 mg/mL)|
15993585|NCT02937740|Drug|NATESTO Testosterone Nasal Gel|"Participants will be instructed to administer 5.5 mg of testosterone (1 actuation) per nostril of NATESTO Testosterone Nasal Gel once in the morning and once in the evening (at least 6 hours apart), preferably at the same time each day for a total daily dose of 22 mg/day of testosterone. Patients should be instructed to completely depress the pump 1 time in each nostril to receive the total dose.
~For three times daily (after Visit 4 [Day 90] if symptoms not adequately managed by a BID dose), NATESTO will be administered intranasally once in the morning, once in the afternoon and once in the evening (approximately 6-8 hours apart), preferably at the same time each day for a total daily dose of 33 mg/day of testosterone."
15993586|NCT02937727|Device|3T MRI compatible and LFP recordable G106R of Beijing Pins medical.|
15993587|NCT02937714|Other|School Mental Health training|School based intervention (Teacher training intervention) is the teachers training program based on World Health Organization, Eastern Mediterranean Region (WHO-EMRO) School mental health manual draft (December 2014). Topics to be covered in training workshop include normal childhood development, behaviour management strategies for schools, life skills training, essential components for healthy schools, recognizing warning signs for common psychiatric and developmental disorders common to children and adolescents & school based interventions for various psychiatric problems
15993588|NCT02937701|Biological|ABP 710|Administered by intravenous infusion
15993589|NCT02937701|Biological|Infliximab|Administered by intravenous infusion
15993590|NCT02937688|Device|Medtronic DBS Therapy for Parkinson's disease|Bilateral Deep Brain Stimulation (DBS) of the Subthalamic Nucleus or Globus Pallidus interna.
15993591|NCT02937675|Drug|Tomivosertib (eFT-508)|eFT508
15993592|NCT02937662|Drug|Idarubicin|Idarubicin at a dose of 10 mg/㎡/d on days 1-3.
15993593|NCT02937662|Drug|Cytarabine|Cytarabine at a dose of 100mg/㎡/d on days 1-7.
15993594|NCT02937662|Drug|Cyclophosphamide|Cyclophosphamide at a dose of 350mg/㎡/d on the second day and the fifth day.
15993595|NCT02937662|Drug|Physician-Directed Regimens without Cyclophosphamide|Regimen without cyclophosphamide including FLA±G regimen, DA regimen, AAG regimen, decitabine with AA regimen.
15993596|NCT02937649|Procedure|Laparoscopic sleeve gastrectomy using 48-Fr bougie|After gastric mobilization, the 48-Fr bougie is inserted through the mouth by the anesthesiologist and positioned in the stomach. Patient is blind to the type of bougie used. Gastrectomy is performed alongside the calibration bougie.
15993597|NCT02937649|Procedure|Laparoscopic sleeve gastrectomy using standard care bougie|After gastric mobilization, the standard care bougie is inserted through the mouth by the anesthesiologist and positioned in the stomach. Patient is blind to the type of bougie used. Gastrectomy is performed alongside the calibration bougie.
15993598|NCT02937636|Other|Stannous fluoride|Experimental dentifrice containing 0.454% w/w stannous fluoride & 0.0721% w/w sodium fluoride containing1450 parts per million (ppm) fluoride
15993599|NCT02937636|Other|Sodium monofluorophosphate|Dentifrice containing 0.14% w/w sodium monofluorophosphate containing1400 ppm fluoride
15993601|NCT02937610|Procedure|percutaneous endoscopic gastrostomy|PEG tube inserted with pull technique
15993602|NCT02937597|Behavioral|ePBP: eProficiency Based Progression|National e-learning programme plus Proficiency-based progression through 4 scenarios in an online learning course and facilitator when requested
15993603|NCT02937597|Behavioral|eS: eScenarios|National e-learning programme plus access to 4 scenarios in an online learning course and facilitator when requested
15993604|NCT02937597|Behavioral|HSE|National HSE e-learning programme only
15993605|NCT02937584|Drug|GP MDI (PT001) 14.4 μg|Glycopyrronium
15993606|NCT02937584|Drug|FF MDI (PT005) 9.6 μg|Formoterol Fumarate
15993607|NCT02937571|Drug|Carfilzomib|
15993608|NCT02937571|Drug|Lenalidomide|
15993609|NCT02937571|Drug|Dexamethasone|
15993610|NCT02937558|Drug|Glucagon|Room-temperature-stable, non-aqueous injectable liquid formulation of synthetic glucagon peptide
15993611|NCT02937558|Other|Placebo|Isotonic saline
15993612|NCT02937545|Other|Medication Therapy Management|Community pharmacists will provide medication therapy management in combination with pharmacogenetic testing
15993613|NCT02937545|Other|Pharmacogenetic testing|Community pharmacist will provide pharmacogenetic testing.
15993614|NCT02937532|Behavioral|GHE + TOBT training|All subjects will receive 45 minutes of GHE, followed by 45 minutes of TOBT program twice a week for 8 weeks.
15993615|NCT02937532|Behavioral|CBT + TOBT training|All subjects will receive 45 minutes of CBT, followed by 45 minutes of TOBT program twice a week for 8 weeks.
15993616|NCT02937519|Device|Chrono-chemotherapy pump:Melodie|
15993617|NCT02937519|Device|Routine intravenous drip|
15993618|NCT02937519|Drug|induction Chrono-chemotherapy|
15993619|NCT02937519|Drug|induction Routine-chemotherapy|
15993620|NCT02937519|Drug|cisplatin chrono-chemotherapy|
15993621|NCT02937519|Drug|cisplatin routine-chemotherapy|
15993622|NCT02937519|Radiation|intensity-modulated radiation therapy|
15993623|NCT02937506|Drug|Propofol|The intervention is to use propofol as anesthesia during a colonoscopy.
15993624|NCT02937506|Drug|Fentanyl Plus Midazolam|The control is to use standard of care anesthesia, fentanyl and midazolam, during a colonoscopy.
15993625|NCT02937493|Behavioral|Lunar phases|Observation if lunar phases had an influence on occurrence of IPV
15993626|NCT02937480|Other|Task-specific training|The task-specific training will be composed by 30 minutes for upper limb and 30 minutes for lower limb tasks. Subjects will performed five minutes of exercise in each station of the circuit and only the last station will last 10 minutes and will involve a walking training with auditory stimulation. Individuals will be encouraged to work as hard as possible at each station and verbal feedback and instructions aimed at improving performance will be taken. Between each task, the participants will be allowed to rest for at least 1-2 minutes, and individual adjustments will be carried out for better adaptations to the training.
15993627|NCT02937480|Other|Global stretching, memory exercises, health care orientation|The control intervention will be composed by 40 minutes for global stretching, 20 minutes of memory exercises and health care orientation
15993628|NCT02937467|Device|SWE|a novel ultrasound-based elastographic method, a new real-time, quantitative, operator-independent, and reproducible technique
15993629|NCT02937454|Drug|ferric carboxymaltose|FCM will be administered as an undiluted bolus injection. The study treatment dose (mL) to be administered will be determined by the patient's body weight and haemoglobin (Hb) value at the respective visits where study treatment will be administered
15993630|NCT02937454|Other|Normal saline 0.9%|Normal saline will be administered as a bolus injection.
15993631|NCT02937441|Other|Ultrasonic Measurement|"How we measure;
~First measurement shall be taken in 4 hours.
~Second measurement shall be taken at 12 hours in mild and 12-18 hours measurement shall be taken for severe diabetic ketoacidosis,
~Third measurement shall be taken after fluid treatment.
~Fourth measurement shall be taken at patients polyclinic control."
15993632|NCT02937428|Behavioral|Look away from the needle|Participant looks away from the needle during vaccination
15993633|NCT02937428|Behavioral|Look at the needle|Participant looks at the needle during vaccination
15993634|NCT02937415|Procedure|Breath carbon monoxide|Breath carbon monoxide measurement.
15993635|NCT02937415|Procedure|Pulmonary function tests.|Measurement of lung functions by blowing through a tube which measures flow and volumes of participant's lungs.
15993636|NCT02937415|Procedure|Oxidative stress and antioxidant status.|Measurement of parameters of oxidative stress and antioxidant status in blood samples.
15993637|NCT02937402|Procedure|Bronchoscopy with Bronchoalveolar Lavage|Undergo bronchoscopy with bronchoalveolar lavage
15993638|NCT02937402|Other|Laboratory Biomarker Analysis|Laboratory Biomarker Analysis
15993639|NCT02937389|Procedure|Patients after esophagectomy|Endoscopic examinations are performed at 1, 8, and 15 postoperative days. Endoscopic examination is added when abnormal findings are demonstrated.
15993640|NCT02937376|Drug|N-acetyl cystein|A trial of exercise before and after 4 weeks of N-acetyl cystein (NAC) supplementation.
15993641|NCT02937376|Other|Placebo|A trial of exercise before and after 4 weeks of placebo administration.
15993642|NCT02937363|Dietary Supplement|Alpha-lipoic acid|A trial of exercise before and after 4 weeks of alpha-lipoic acid supplementation.
15993643|NCT02937363|Other|Placebo|A trial of exercise before and after 4 weeks of placebo administration.
15993644|NCT02937350|Drug|D6-25-hydroxyvitamin D3|Intravenous administration of a deuterium-labeled 25(OH)D3 to evaluate the metabolic clearance of 25(OH)D3
15993645|NCT02937337|Device|Laryngeal mask insertion with videostylet guided technique|
15993646|NCT02937337|Device|Laryngeal mask insertion with standard blind technique|
15993647|NCT02937324|Device|CloudUPDRS smartphone software assessment|Smartphone software consisting of a series of tapping and tremor-measurement tests designed to measure a subset of the UPDRS.
15993648|NCT02937324|Other|Clinical assessment|A clinician will assess the motor signs of the participant using the Unified Parkinson's Disease Rating Scale. The examination will be videoed and rated by 3 blinded examiners.
15993649|NCT02937311|Other|NMES|Participants received NMES using a portable, page-sized battery-powered stimulation device, which delivered current-regulated, charge-balanced, asymmetrical biphasic pulses. The implementation was done on the deltoid and supraspinatus muscles
15993805|NCT02936206|Drug|Fulvestrant|fulvestrant 750 mg (three 5 ml injections slowly over 1-2 mn per injection in the buttocks) on day 1 only
15993650|NCT02937311|Other|Kinesiotape|The deltoid and supraspinatus muscles were taped in this study to align the shoulder in correct position to facilitate the function and achieve preferred body alignment. For supraspinatus application, Y strip tape was applied from the muscle insertion at the greater tuberosity of the humerus to its origin at the supraspinatus fossa of the scapula while the muscle was in an overstretched position. No tension was applied to the tape. For deltoid application, Y-shaped tape was used by placing the anchor acromion process. The front tail was implemented in the extended arm position, while the back tail was implemented in the horizontal abducted arm position. Both tails ended below the deltoid tubercule of the humerus. No tension was applied during application.
15993651|NCT02937311|Other|Standardized Physiotherapy|All participants received rehabilitation including Bobath neurophysiological approach. Bobath approach and other exercise programs were implemented early after the onset of the stroke to prevent immobility and soft tissue contracture and to alter the muscle tone to gain mobility. Through the exercise program and use of weight-bearing techniques, the therapist attempted to maintain and improve trunk and shoulder alignment to allow the functional use of the upper extremity.
15993652|NCT02937298|Dietary Supplement|Control Meal|This will consist of standard breakfast foods (cereal, milk, yoghurt, cheese cracker bread, butter, banana and cream
15993653|NCT02937298|Dietary Supplement|Berry Treatment|This will consist of standard breakfast foods (cereal, milk, yoghurt, cheese cracker bread, butter, banana and cream plus a berry smoothie. The berry smoothie consists of blueberries, raspberries and blackberries.
15993654|NCT02937298|Dietary Supplement|Sea Buckthorn Treatment|This will consist of standard breakfast foods (cereal, milk, yoghurt, cheese cracker bread, butter, banana and cream plus a sea buckthorn berry smoothie.
15993655|NCT02937298|Dietary Supplement|Wild Garlic Treatment|This will consist of standard breakfast foods (cereal, milk, yoghurt, cheese cracker bread, butter, banana and cream. The wild garlic will be prepared and served as a dip alongside.
15993656|NCT02937285|Drug|Interferon beta 1a|Subcutaneous injection of 44µg 3 times a week
15993657|NCT02937285|Drug|Mitoxantrone|10 mg / m² monthly infusion for 6 months
15993658|NCT02937272|Drug|LY3200882|Administered orally
15993659|NCT02937272|Drug|LY3300054|Administered intravenously
15993660|NCT02937272|Drug|Gemcitabine|Administered intravenously
15993661|NCT02937272|Drug|nab-Paclitaxel|Administered intravenously
15993662|NCT02937272|Drug|Cisplatin|Administered intravenously
15993663|NCT02937272|Radiation|Intensity Modulated Radiotherapy|
15993664|NCT02937259|Other|Patient self-admission to inpatient treatment|Participants are given a contract whereby they are offered the possibility to admit themselves at will to the inpatient ward at the Stockholm Centre for Eating Disorders for a maximum of seven consecutive days at a time. They are also free to discharge themselves at any time. The participants may use this opportunity as often as they want to for a period of one year, or longer if the contract is renewed after one year.
15993665|NCT02937246|Device|SEMS(self-expandable metallic stent)|Find the obstruction site by ERCP(endoscopic retrograde cholangiopancreatography) and insertion the SEMS(self-expandable metallic stent) through duodenal endoscopy. Metal stents are inserted to ensure adequate decompression and bile drainage. The diameter and stent lengths can be changed according to the lesion.
15993666|NCT02937246|Device|Stenting by ERCP (endoscopic retrograde cholangiopancreatography)|
15993667|NCT02937233|Biological|Zika Virus Purified Inactivated Vaccine|
15993668|NCT02937233|Other|Placebo|
15993669|NCT02937220|Procedure|monolithic zirconia crown|New crown material used as final restoration for dental implants
15993670|NCT02937220|Procedure|metal ceramic crown|Conventional crown material used as final restoration for dental implants
15993671|NCT02937207|Drug|Ke Chuan Liu Wei Mixture|Experience formula of famous traditional Chinese professor Yingen Wu
15993672|NCT02937207|Drug|Chuan Xiong Ping Chuan Mixture|Experience formula of famous traditional Chinese professor Changrong Shao
15993673|NCT02937207|Drug|Xie Wu Capsule|Experience formula of famous traditional Chinese professor Jianhua Hu
15993674|NCT02937207|Drug|Dan Ma Jia Tablet|Experience formula of famous traditional Chinese professor Xiaopu Xu
15993675|NCT02937207|Drug|Zhi Chuan Capsule|Experience formula of famous traditional Chinese professor Yingen Wu
15993676|NCT02937207|Drug|Bu Shen Na Qi Granule|Experience formula of famous traditional Chinese professor Changrong Shao
15993677|NCT02937207|Drug|Ke Chuan Liu Wei Mixture placebo|Low dose combination for treating prescription of Ke Chuan Liu Wei Mixture
15993678|NCT02937207|Drug|Chuan Xiong Ping Chuan Mixture placebo|Low dose combination for treating prescription of Chuan Xiong Ping Chuan Mixture
15993679|NCT02937207|Drug|Xie Wu Capsule placebo|Low dose combination for treating prescription of Xie Wu Capsule
15993680|NCT02937207|Drug|Dan Ma Jia Tablet placebo|Low dose combination for treating prescription of Dan Ma Jia Tablet
15993681|NCT02937207|Drug|Zhi Chuan Capsule placebo|Low dose combination for treating prescription of Zhi Chuan Capsule
15993682|NCT02937207|Drug|Bu Shen Na Qi Granule placebo|Low dose combination for treating prescription of Bu Shen Na Qi Granule
15993683|NCT02937194|Behavioral|Personal oral health instruction + pamphlets distribution|Personal oral health instruction (OHI) and oral health pamphlets distribution
15993684|NCT02937194|Behavioral|Pamphlets distribution|Oral health pamphlets distribution
15993685|NCT02937181|Drug|Ceftaroline|IV Ceftaroline will be given for 72 hours
15993686|NCT02937168|Drug|Reslizumab|Reslizumab will be administered as per the dose and schedule specified in the arm.
15993687|NCT02937168|Drug|Fludeoxyglucose F 18 (FDG)|FDG will be administered by IV infusion prior to each PET/CT scan.
15993688|NCT02937168|Drug|Placebo|Placebo matching to reslizumab will be administered as per the schedule specified in the arm.
15993689|NCT02937142|Behavioral|cognitive behavior group therapy|1,5 hours weekly session during 12 weeks, 8 participants, 2 therapists.
15993690|NCT02937142|Other|Treatment as usual|Education on ADHD, and ADHD medication if indicated
15993691|NCT02937116|Drug|IBI308|
15993692|NCT02937116|Drug|IBI308\Cisplatinum\Pemetrexed|
15993693|NCT02937116|Drug|IBI308\cisplatin\gemcitabine|
15993694|NCT02937116|Drug|IBI308\oxaliplatin\capecitabine|
15993695|NCT02937116|Drug|IBI308\etoposide\cisplatin|
15993696|NCT02937116|Drug|IBI308\irinotecan\5-FU|
15993697|NCT02937103|Biological|Anti-CD123-CAR-transduced T cells|The first 3 enrolled patients will receive autologous-derived CD123-targeted CAR-T cells on day 1, 2 and 3 with respective 10%, 30% and 60% of the total expected dosage after receiving lymphodepleting chemotherapy. If the 3 patients don't display severe toxicity,the next patients enrolled will get infused in 2 days with respective 40% and 60% total dosage.
15993698|NCT02937090|Other|Blood Draw|Blood sample will be drawn from participants at study entry.
15993699|NCT02937090|Other|Stool collection|Stool will be collected from participants at study entry.
15993700|NCT02937077|Device|Medtronic Reveal LINQ|
15993701|NCT02937051|Other|Tobacco product administration and assessment|two bouts of 10 puffs of a tobacco product with a 30-second interpuff interval separated by 60 minutes; preceded and followed by physiological, subjective and topography assessment
15993702|NCT02937025|Device|The Left Atrial Appendage Occulder of Shanghai Push Medical Device Technology CO.td|Implanting the Occluder to close the left atrial appendage
15993703|NCT02937012|Drug|Bezafibrate|Bezafibrate 200 mg manufactured in a pill/capsule presentation
15993704|NCT02937012|Drug|Ursodeoxycholic Acid|The patients will continue with the administration of ursodeoxycholic acid at a dose of 13 to 15 mg per Kg per day throughout the study
15993705|NCT02937012|Drug|Placebo (for Bezafibrate)|Starch pill/capsule manufactured to mimic bezafibrate 200 mg tablet
15993706|NCT02936999|Drug|Cholecalciferol|Cholecalciferol 100,000 IU followed by 4000 IU orally once daily for 30 days.
15993707|NCT02936973|Device|Real catgut implantation at acupoints|"Absorbable surgical suture will be embedded in acupoints as below. Group A ：Zhigou (TE 6), Tianshu (ST25), Weishu (BL21), Zhongwan (CV12) and Zusanli (ST36); Group B ：Quchi (LI11), Huaroumen (ST24), Pishu (BL20), Shuifen (CV9), and Fenglong (ST40). Each group will be used alternatively and treated once every 2 weeks.
~lifestyle intervention :Experienced nutritionists calculated every participant's basal metabolic rate,then designed a proper diet and exercise treatment for them. During the treatment, a diet and exercise diary will be distributed to the patients, and detailed guidance concerning their diet and exercise will be provided according to the diary. The patients should be encouraged to maintain the diet and exercise diary for at least 4 days per week ."
15993708|NCT02936973|Device|sham catgut implantation at acupoints|"Empty needles without catgut will be pushed into the chosen position as below :Group A ：1 cun lateral from the Zhigou (TE 6), Tianshu (ST25), Weishu (BL21), Zhongwan (CV12) and Zusanli (ST36); Group B ：1 cun lateral from the Quchi (LI11), Huaroumen (ST24), Pishu (BL20), Shuifen (CV9), and Fenglong (ST40).Those two groups of acupoints will ultimately be selected for alternative treatment. Each group will be used alternatively and treated once every 2 weeks.
~lifestyle intervention :It will be performed as the same as the real catgut implantation at acupoints group."
15993709|NCT02936947|Device|High Frequency Percussive Ventilation|High Frequency Percussive Ventilation
15993710|NCT02936947|Other|Free breathing|Free breathing
15993711|NCT02936947|Other|Active Breathing Control|Active Breathing Control
15993712|NCT02936934|Drug|Morphine|"Interventions pre-specified to be administered to participants:
~Abdominal hysterectomy Block Anesthesia: bupivacaine 0.5% + 25 micrograms of fentanyl 10mg / kg metamizol sodium intravenously during surgery
~Intravenous infusion:
~200μg / kg of morphine + 3g metamizole sodium + 3mg / kg 2% lidocaine + 500mL saline solution. Time administration:24hours"
15993713|NCT02936934|Drug|Oxycodone|"Interventions pre-specified to be administered to participants:
~Abdominal hysterectomy Block Anesthesia: bupivacaine 0.5% + 25 micrograms of fentanyl 10mg / kg metamizol sodium intravenously during surgery
~Intravenous infusion:
~150μg / kg of oxycodone + 3g metamizole sodium + 3mg / kg 2% lidocaine + 500mL saline solution. Time administration: 24hours."
15993714|NCT02936908|Other|Ventilatory support|Initiation of mechanical ventilatory support, invasive or non-invasive, Or modification of mechanical ventilatory support (modification of the parameters of the device, change of material, switch from non-invasive to invasive)
15993715|NCT02936895|Drug|Vitamin D3|vitamin D at a dose of 50,000 IU per day for 2 days
15993716|NCT02936895|Drug|Placebo|Placebo for 2 days
15993717|NCT02936882|Procedure|Preoperative gastric ultrasonography|Before surgical emergency procedure, a preoperative antral ultrasonography is performed to assess gastric content.
15993718|NCT02936869|Behavioral|Performance-based monetary incentives|
15993719|NCT02936856|Device|Hepatic Arteriography|
15993720|NCT02936843|Drug|Salsalate|1 gram, 3 times daily by mouth (total of 3 grams daily)
15993721|NCT02936843|Drug|PLACEBO|Placebo for Salsalate; 2 Tabets, 3 times daily by mouth (total of 3 grams daily)
15993722|NCT02936830|Drug|5% Sodium Fluoride Varnish|5% sodium fluoride varnish applied on the dentin by the dentist
15993723|NCT02936830|Drug|15% Nanohydroxyapetite paste|15% nanohydoxyapetite paste without potassium nitrate or fluoride applied on the dentin by the dentist
15993724|NCT02936830|Drug|Glycerol|Glycerol with water in a 1: 1 ratio
15993725|NCT02936817|Device|Aerobika® Device|For a period of 15 +/- 3 days subjects will use the Aerobika® device before administration of their stable standard of care treatment regimen (i.e. study patients should use the device before each inhalation medication administration, with a minimum use of the device of twice daily).
15993726|NCT02936817|Radiation|HRCT scans|A HRCT scan at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) will be taken on visit 1, and visit 3. An upper airway (UA) scan will be taken on visit 1.
15993727|NCT02936804|Device|Low Dose Computed Tomography|LDCT was performed at baseline and 2 rounds of biennial repeated LDCT. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 4 mm. The management of abnormal nodules including precision diagnosis by endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), electromagnetic navigation bronchoscope (ENB) and peripheral biomarkers, and precision therapy by intraoperative frozen section guided lung resection and ENB radiofrequency ablation.
15993728|NCT02936765|Device|Anterior cervical discectomy with prosthetic disc replacement / ESP.|Anterior cervical discectomy, with the use of the ESP prosthesis (Manufacturer: FH orthopedics, Mulhouse, France) for the disc replacement.
15993729|NCT02936765|Device|Anterior cervical discectomy with prosthetic disc replacement / Squale.|Anterior cervical discectomy, with the use of the Squale spacer (Manufacturer: OSD, Avignon, France) for the disc replacement.
15993730|NCT02936752|Drug|Entinostat|Given PO
15993731|NCT02936752|Biological|Pembrolizumab|Given IV
15995418|NCT02924415|Other|Control group|Standard care
15993732|NCT02936739|Device|Anterior cervical discectomy with prosthetic disc replacement / ESP.|Anterior cervical discectomy, with the use of the ESP prosthesis (Manufacturer: FH orthopedics, Mulhouse, France) for the disc replacement.
15993733|NCT02936739|Device|Anterior cervical discectomy with prosthetic disc replacement / Rotaio.|Anterior cervical discectomy, with the use of the Rotaio prosthesis (Manufacturer: Signus Med, Alzenau, Germany) for the disc replacement.
15993734|NCT02936726|Behavioral|Exercise, Health Coaching and Meditation|Comparing Exercise, Health Coaching and Meditation In Combination
15993735|NCT02936726|Behavioral|Exercise and Health Coaching|Comparing Exercise and Health Coaching Alone
15993736|NCT02936713|Other|Fermented milk product with probiotics (FMPP)|2 pots of 125g FMPP / day
15993737|NCT02936700|Behavioral|Relaxation|relaxation program consists of 7 weekly, 2 hours sessions led by two therapist. Each group will consist of 7 participants.
15993738|NCT02936700|Behavioral|ACT therapy|"7 weekly, 2 hours sessions led by two therapist. Each group will consist of 7 participants. The ACT program aims at
~decreasing the tendency to try to escape unpleasant mental experiences
~increasing psychological flexibility
~developing acceptance of psychological events and engagement in valued actions"
15993746|NCT02936674|Device|Light - standard|Light will be given during the night to determine its effects on melatonin suppression. This light will be an LED with standard spectral distribution
15993747|NCT02936674|Device|Light - alternate|Light will be given during the night to determine its effects on melatonin suppression. This light will be an LED with an altered spectral distribution (different color)
15993748|NCT02936661|Drug|Tranexamic Acid|
15993749|NCT02936661|Drug|Placebo|
15993750|NCT02936648|Other|quality improvement intervention|The intervention activities included: assessment, planning, stakeholder engagement, education, ongoing process monitoring, program adaptation, problem identification and problem solving, data audit/feedback, program marketing, network development, among others.
15993751|NCT02936635|Drug|tirasemtiv|Oral
15993752|NCT02936622|Device|Zilver® Paclitaxel-Eluting Peripheral Stent|Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.
15993753|NCT02936622|Device|Zilver® Paclitaxel-Eluting Peripheral Stent with slower-dissolving polymer-free paclitaxel coating|Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.
15993754|NCT02936622|Device|Zilver® Paclitaxel-Eluting Peripheral Stent with higher-dose polymer-free paclitaxel coating|Paclitaxel belongs to the Taxane drug class and coated on the stent at a much lower dose than when administered as a chemotherapy agent.
15993755|NCT02936609|Other|Medicaid Expansion|There will be no direct intervention, but rather an observation of change based on whether a state expanded Medicaid or not
15993758|NCT02936583|Drug|BAY987521|"Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
~(Formulation Code:Z09-067)"
15993759|NCT02936570|Drug|BAY987521|"Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
~(Formulation Code:Z09-067)"
15993760|NCT02936557|Drug|BAY987521|"Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
~(Formulation Code:Z09-054)"
15993761|NCT02936544|Drug|BAY987521|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code:Z09-054)
15993762|NCT02936518|Procedure|Lingual frenotomy and/or maxillary labial frenectomy|
15993763|NCT02936505|Drug|Cyclosporine|"Cyclosporin A (Sandimmun Neoral® or similar):
~Cyclosporin A given orally pretransplant in the dose of 2-3 mg/kg.
~Continued postop day 1 in the dose of 3mg/kgx2, according to local practice and blood concentration: 0-3 months 250-300; 3-6 months 200-250; 6-12 months 150-200; >12 months 100-150 ng/ml. Cyclosporine A will be administered twice daily."
15993764|NCT02936505|Drug|Mycophenolate mofetil (MMF)|"MMF target dose: 2000 mg/day (1gx2):
~o Controlled by a single Area Under the Curve (AUC) measurement day 90 with a target AUC between 40 and 60 mg.h/L and corrected accordingly."
15993765|NCT02936505|Drug|Rabbit Anti thymocyte globulin|Induction therapy: Thymoglobulin® (Rabbit Anti thymocyte globulin)(1.5 mg/kg given immediately postoperatively).
15993806|NCT02936206|Drug|Tamoxifen|14 days of treatment with tamoxifen 20mg orally each day
15993766|NCT02936505|Drug|Corticosteroids|"Corticosteroids:
~Day 0 (day of lung transplantation); 500+500mg methylprednisolone iv. before reperfusion, i.e. restoration of blood flow into the transplanted allograft.
~From day 1: Initiated at 0.2 mg/kg/day; tapered to 0.1 mg/kg 3-6 months; less than 0,1 mg/kg > 6 months."
15993767|NCT02936505|Drug|Tacrolimus|"Tacrolimus should be given orally pretransplant in the dose of 0.1 mg/kg.
~Continued postop day 1 according to local practice and blood concentration: 0-3 months 10-14, 3-6 months 8-12, 6-12 months 8-10, >12 months 6-8 ng/ml. Tacrolimus will be administered once daily."
15993768|NCT02936492|Drug|BAY1003803 0.01% lipophilic cream|Topical administration for 22 h per day
15993769|NCT02936492|Drug|BAY1003803 0.1% lipophilic cream|Topical administration for 22 h per day
15993770|NCT02936492|Drug|BAY1003803 0.01% ointment|Topical administration for 22 h per day
15993771|NCT02936492|Drug|BAY1003803 0.1% ointment|Topical administration for 22 h per day
15993772|NCT02936492|Drug|Lipophilic cream vehicle|Topical administration for 22 h per day
15993773|NCT02936492|Drug|Ointment vehicle|Topical administration for 22 h per day
15993774|NCT02936492|Drug|Clobetasol propionate|Topical administration for 22 h per day
15993775|NCT02936479|Drug|C1-INH (Berinert)|
15993776|NCT02936466|Behavioral|Bipolife® group|"The participant is proposed to play to the serious game Bipolife® with following instructions :
~At least one connection per week during 4 weeks
~Connection time is free On add on of usual treatment After the 4 weeks and the first visit (V1), the participant can continue to participate to the serious game as much as he wishes, without any specific instructions.
~After connecting to the site www.bipolar.ubi.com, the participant is proposed to create his avatar and conduct him on his house. He realizes different kind of daily actions (like sleeping, sport activity, cooking) ; every action lead to win or to loose energy and mood points. The final aim is to stabilize the avatar's mood. Thanks to this experience, the participant can learn to distinguish positive and negative actions impacting on his condition."
15993777|NCT02936453|Procedure|Device implantation|"Implantation of Specify 5-6-5 lead or Go-2 lead in epidural space
~Implantation of Activa RC neurostimulator"
15993778|NCT02936427|Drug|Dexamethasone|perineural infiltration of dexamethasone
15993779|NCT02936414|Drug|Berberine|Berberine (300 mg/tid), as an adjuvant therapy will be used on the basis of the SGAs monotherapy.
15993780|NCT02936414|Drug|Placebo|Accept placebo(300 mg/tid)+SGAs monotherapy.
15993781|NCT02936401|Behavioral|MBSR|Mindfulness Based Stress Reduction (MBSR) is a standardized 8 week course taught by trained instructors.
15993782|NCT02936388|Procedure|SIRT|catheter-based application of radioactive microspheres into the hepatic artery
15993783|NCT02936388|Procedure|DSM-TACE|catheter-based application of chemotherapy and degradable starch microspheres into the hepatic artery
15993784|NCT02936375|Drug|Iguratimod|25mg twice a day, orally administrated
15993785|NCT02936375|Drug|Cyclophosphamide|1g/m², every 4 weeks, intravenous
15993786|NCT02936375|Drug|Azathioprine|2mg/kg·d, once a day, orally administrated
15993787|NCT02936375|Drug|Steroids|Prednisone, methylprednisolone or prednisonlone, once a day, orally administrated. Steroids should be 1mg/kg·d in the beginning four weeks, then tapered 5-10mg/d every two weeks till 30mg/d, then tapered 2.5-5mg/d every two weeks. After 24 weeks of follow-up, a patient should receive steroids no more than 10mg/d. Patients may receive temporal high dose of steroids (1mg/kg·d) because of symptoms outside of kidney, for no more than two weeks. All the dosage of steroids above is calculated by prednisone.
15993788|NCT02936362|Other|Consumption of sourdough bread|Participants will be given sourdough bread to consume instead of other wheat products. 145g will be consumed every morning in addition to ad libitum consumption throughout the day (matched between first and second intervention periods)
15993789|NCT02936362|Other|Consumption of white bread|Participants will be given white bread to consume instead of other wheat products. 110g will be consumed every morning in addition to ad libitum consumption throughout the day (matched between first and second intervention periods)
15993790|NCT02936349|Other|Transthoracic Contrast Echocardiogram|A transthoracic contrast echocardiogram (TTCE) is a still or moving image of the internal parts of the heart using ultrasound following the injection of microbubble contrast (agitated saline) into a vein in the arm, which then travels to the heart.
15993791|NCT02936336|Other|exercise|circuit exercise, aerobic dance and Tai Chi exercise
15993792|NCT02936323|Drug|PEN-221|Administration of PEN-221 once every three weeks
15993793|NCT02936310|Behavioral|Mindful Living With Stress|The proposed Mindful Living With Stress Intervention will be conducted weekly, 2 hours per session, 4-6 sessions, group based program in mindfulness.
15993794|NCT02936297|Dietary Supplement|High dose Gluten|
15993795|NCT02936297|Dietary Supplement|Low dose Gluten|
15993796|NCT02936297|Dietary Supplement|Lactose free placebo|
15993797|NCT02936284|Behavioral|Music Enhancement|
15993798|NCT02936284|Behavioral|Play Date|
15993799|NCT02936271|Other|Vasculera|"Vasculera is a specially formulated prescription medical food product. This study compares Vasculera to placebo at reducing post procedural pain, bruising and edema for patients requiring an intervention for lower extremity venous disease.
~Patient will be randomized to receive Active Vasculera or Vasculera Placebo. The study product will be taken for two weeks prior to the patient's planned procedure and continued for four weeks after their procedure. If multiple procedures are required the patient will be instructed to use the product throughout treatment."
15993800|NCT02936271|Other|Placebo|
15993801|NCT02936258|Procedure|Standard of Care|Men in Arm B will undergo a 12-core systematic TRUS guided biopsy. All men in the study will be followed for two years or until they have had radical treatment (whichever comes first).
15993802|NCT02936258|Procedure|MRI|Men will undergo a MRI followed by either a targeted biopsy of suspicious areas or will be followed for two years if there is no suspicious areas identified by MRI.
15993803|NCT02936258|Procedure|MRI Targeted Biopsy|Men will undergo a MRI followed by either a targeted biopsy of suspicious areas or will be followed for two years if there is no suspicious areas identified by MRI.
15993804|NCT02936245|Other|no specific intervention|We will not assign specific intervention in this research. We will record their baseline characteristics, received treatment, and assess the outcomes to analysis the predictors of outcome and natural history in patients with cervical spondylotic myelopathy.
15994710|NCT02929485|Drug|Placebo|Placebo (200mg) administered at study visit
15993807|NCT02936193|Procedure|Pylorus preservation|Patients undergo Laparoscopic Gastrectomy featuring pylorus-preservation
15993808|NCT02936193|Procedure|Distal gastrectomy|Patients undergo laparoscopic gastrectomy in distal gastric resection with D2 lymphadenectomy
15993809|NCT02936180|Biological|HD-TIV|
15993810|NCT02936180|Biological|SD-QIV|
15993811|NCT02936167|Biological|Ringer Lactate|
15993812|NCT02936167|Biological|Plasmalyte|
15993813|NCT02936154|Drug|PF-06650833|
15993814|NCT02936154|Drug|placebo|
15993815|NCT02936141|Behavioral|Group psychotherapy|Includes a group (up to 10 participants) weekly session with a duration of 90 minutes where it is stimulated communication, adaptative behaviour and social living
15993816|NCT02936128|Other|TruSkin|
15993817|NCT02936128|Other|Wound Cover|
15993818|NCT02936115|Other|TruSkin®|
15993819|NCT02936115|Other|Wound Cover|
15993820|NCT02936102|Drug|FAZ053|Anti-PD-L1 Antibody
15993821|NCT02936102|Drug|PDR001|Anti-PD-1 Antibody
15993822|NCT02936089|Drug|Ara-C|Ara-C was administered at 1-2 g/m2 q12 h ×6 cycles
15993823|NCT02936089|Other|autologous HSCT|
15993824|NCT02936089|Other|allogeneic HSCT|
15993825|NCT02936076|Other|Exercise intervention|
15993826|NCT02936076|Other|Delayed exercise intervention|
15993827|NCT02936063|Procedure|Surgical staples|Closure of surgical wound at skin level with surgical staples
15993828|NCT02936063|Procedure|Subcuticular sutures|Closure of surgical wound at skin level with subcuticular sutures
15993829|NCT02936050|Procedure|Diagnostic ultrasound|All participants will be examined by diagnostic ultrasound by nurses for the assessment of the Cardiac size and function, and for volumic state. Transmission of the ultrasound recordings by telemedicine and interpretation by specialist in echocardiography and heart failure. All participants will then be examined by reference imaging in specific ultrasound laboratories.
15993830|NCT02936037|Drug|MD1003 100mg capsule|
15993831|NCT02936037|Drug|PLACEBO|an inactive substance
15993832|NCT02936024|Procedure|Two-Stage GSLO Technique|The patient will initially receive the first stage of the two-stage technique which involves the ligation of testicular vessels laparoscopically, or transection of these vessels using cautery. After the first stage is complete, the patient will be seen approximately 3-6 months later for the second stage. The second stage of the procedure involves free mobilization of the testis and placement/fixation of the testicle in the scrotum.
15993833|NCT02936024|Procedure|One-Stage GSLO Technique|The patient will receive only one surgical procedure during which ligation of testicular vessels is performed, as well as mobilization of the testis and placement/fixation of the testicle in the scrotum.
15993834|NCT02936011|Device|CTO PCI using Absorb Bioresorbable Vascular Scaffolds|CTO PCI
15993835|NCT02935998|Drug|Ziprasidone|During the study, at least 1 injection is needed per day. Whether the second, third or fourth one is needed according to patients' symptoms. If the BARS score>=5, clinicians are supposed to give 10mg or 20mg.If lower than 5, clinicians could choose to give 10mg or not according to patients' symptoms and doctor's experience. Doses of 10 mg may be administered every two hours; doses of 20 mg may be administered every four hours up to a maximum of 40 mg/day.It is not recommended to combine with other oral antipsychotic drugs. But if the patients' daily dose of injection has reached 40mg and agitation occurred 4 hours later after the last injection, with the BARS score higher than 5.The clinicians can determine whether or not to combine oral antipsychotic drug, and the dosage.
15993836|NCT02935985|Other|Point-of-care bio-markers (cTnI, hsCRP, D-Dimer) and biological parameters (CBC, glucose, cholesterol, LDL cholesterol, triglycerides, fibrinogen)|"Clinical evaluations will be performed, along with collecting venous blood samples for determining point-of-care bio-markers and biological parameters.
~Participants will be assessed (clinically or by telephone) over a period of 180 days."
15993837|NCT02935972|Drug|Diazepam|received intravenous diazepam 5 mg slowly just before TRUS probe insertion
15993838|NCT02935972|Drug|Lidocaine 1%|received 10 cc of 1% Lidocaine injected into the periprostatic nerve plexus bilaterally under ultrasound guidance
15993839|NCT02935972|Drug|Diazepam and Lidocaine 1%|received intravenous diazepam 5 mg slowly just before probe insertion and 10 cc of 1% Lidocaine injected into the periprostatic nerve plexus bilaterally under ultrasound guidance
15993840|NCT02935959|Drug|nebulized ketamine|Drugs will be prepared in 3 mL of saline 0.9% before administration by a standard hospital jet nebulizer via a mouthpiece, with a continuous flow of 100% oxygen at 6 L/min for 10 to 15 minutes (30 minutes before GA). Treatment will be stopped when the nebulizer began to sputter.
15993841|NCT02935959|Drug|nebulized Dexmedetomidine|
15993842|NCT02935959|Drug|nebulized midazolam|
15993843|NCT02935946|Other|Cold Liquid Barium|Cold Liquid is defined as being between 4-9 °C. One liter bottles of Poland Spring Natural Spring Water will be kept in the radiology suite to remain at room temperature. As described by Fink and colleagues,(42) the bottled water will be used to mix the barium powder to create a thin liquid consistency, with 50% dilution, which is found to be most similar to human milk and infant formula. After the barium is prepared, 2oz will be poured into a bottle and placed in a refrigerator set to 36°F; this will allow the barium to cool to approximately 4-9°C. Before oral administration, the barium mixture will be measured with a thermometer (TP3001 Digital Thermometer from Red Lantern®) to document the exact temperature.
15993844|NCT02935933|Drug|bupivicaine|Paravertebral block
15993845|NCT02935933|Drug|morphine|
15993846|NCT02935933|Drug|Dexmedetomidine|
15993847|NCT02935920|Behavioral|Individualized, tailored follow-up program|Individualized follow-up in the context of shared decision making, with the use of PRO-data to evaluate the patient needs of consultations.
15993848|NCT02935907|Drug|APG-115|Multiple dose cohorts, PO, every other day of a 28 day cycle
15993849|NCT02935894|Drug|Ibuprofen|400 mg ibuprofen given to inhibit cyclooxygenase metabolism
15993850|NCT02935894|Other|Physiological induction of sweating|15 minutes exercise at 60-80% oxygen consumption to induce sweating
15993851|NCT02935894|Drug|Pilocarpine|Iontophoresis with a 1.5 milliampere (mA) current using a gel disc containing a 5% pilocarpine nitrate solution to induce sweating
15993852|NCT02935881|Device|Radio Frequency Ablation (RFA) (Stretta Procedure)|Radio Frequency Ablation (RFA) for the treatment of refractory gastroesophageal reflux disease.
16011826|NCT02798510|Drug|capecitabine|
15993853|NCT02935881|Procedure|Sham Procedure|Stretta device will be used but Radio Frequency Ablation (RFA) will not be generated.
15993854|NCT02935855|Drug|Dabigatran|
15993855|NCT02935855|Drug|Apixaban|
15993856|NCT02935855|Drug|Rivaroxaban|
15993857|NCT02935855|Drug|Edoxaban|
15993858|NCT02935855|Drug|Warfarin|
15993859|NCT02935855|Drug|Acenocumarole|
15993860|NCT02935842|Other|Specific SL-therapy|Provided by a professional speech-language therapist (SLT) on a one-to-one basis. In approx. 45 Minutes sessions, 3 times per week for 4 weeks in total.
15993861|NCT02935842|Other|Rhythmic Balance-Movement Training (rBMT)|Provided on a one-to-one basis. In approx. 30-45 Minutes sessions, 3 times per week for 4 weeks in total.
15993862|NCT02935829|Other|Glucose as reference food|Ten subjects (male: 6, female: 4) consumed 25g glucose diluted in 250ml water, two times, in different weeks, within 5-10 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
15993863|NCT02935829|Other|White bread as reference food|Ten subjects (male: 6, female: 4) consumed 25g available carbohydrate from white bread along with 250ml water, two times, in different weeks, within 10-15 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
15993864|NCT02935829|Other|Carob snack as test food|Ten subjects (male: 6, female: 4) consumed 25g available carbohydrate from carob snack along with 250ml water, one time, in different weeks, within 10-15 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
15993865|NCT02935829|Other|Chocolate cookie snack as test food|Ten subjects (male: 6, female: 4) consumed 25g available carbohydrate from chocolate cookie snack along with 250ml water, one time, in different weeks, within 10-15 min. Fingertip capillary blood glucose samples were taken at baseline, 15, 30, 45, 60, 90 and 120 min.
15993866|NCT02935829|Other|Carob preload|Fifty healthy subjects (male: 22, female: 28) consumed a standardized breakfast (bread and honey) and 2h after were offered a preload given as snack (40g carob snack). Three hours after, subjects were given ad libitum access to a meal (lunch and dessert). The meal consisted of rice, roasted chicken breast and chocolate cake. Foods were weighed before serving and any leftovers were weighed again after meal. Fingertip capillary blood glucose samples were taken before breakfast, 120min after breakfast; before preload, 120minand 180minpost-preload consumption; before meal (lunch and dessert), 60minand 120min post-meal consumption. Subjective appetite ratings were assessed with 100mm VAS.
15993867|NCT02935829|Other|Chocolate cookie preload|Fifty healthy subjects (male: 22, female: 28) consumed a standardized breakfast (bread and honey) and 2h after were offered a preload given as snack (40g chocolate cookie). Three hours after, subjects were given ad libitum access to a meal (lunch and dessert). The meal consisted of rice, roasted chicken breast and chocolate cake. Foods were weighed before serving and any leftovers were weighed again after meal. Fingertip capillary blood glucose samples were taken before breakfast, 120min after breakfast; before preload, 120minand 180minpost-preload consumption; before meal (lunch and dessert), 60minand 120min post-meal consumption. Subjective appetite ratings were assessed with 100mm VAS.
15993868|NCT02935816|Radiation|Whole body MRI|We have developed and assessed the feasibility of performing whole---body multi---parametric MRI for staging metastatic disease. We hypothesize that a whole body multi---parametric MRI will be more sensitive and specific than conventional imaging staging for detection of metastatic disease in patients with biochemical failure following local therapies. We therefore propose a comparative trial of conventional imaging verses whole---body multi---parametric MRI within this population of men
15993869|NCT02935803|Procedure|Trans-vaginal Mesh operation|Modified the transobturator TVM operation reported by Sergent et al. by inserting a stabilizing suture, which fixing the anterior edge of the mesh to the paraurethral tissues at the level of the mid-urethra with two non-resolvable anchoring stitches thereby promoting the proper elevation and closure of the urethra
15993870|NCT02935790|Drug|ACY-241|tablet
15993871|NCT02935790|Drug|nivolumab|infusion
15993872|NCT02935790|Drug|ipilimumab|infusion
15993873|NCT02935777|Dietary Supplement|Pomegranate Extract|The first computer cognitive testing session lasting approximately 45 minutes is undertaken by participants. After completion, intervention capsules are administered. After a 60 minute absorption period, the cognitive testing session is re-administered.
15993874|NCT02935777|Dietary Supplement|Placebo capsule|One computer cognitive testing session lasting approximately 45 minutes is undertaken by participants. After completion, placebo capsules are administered. After a 60 minute absorption period, the cognitive testing session is re-administered.
15993875|NCT02935764|Drug|Irinotecan|180 mg/m2 iv gtt, d1
15993876|NCT02935764|Drug|5-fluorouracil|5-FU 400mg/m2 iv, 2400mg/m2 civ 46h
15993877|NCT02935764|Drug|Leucovorin|400mg/m2 iv gtt,d1
15993878|NCT02935751|Other|Lab tests for plasma levels of apixaban and anti-10a factor|All patients will have a blood draw at 48 hours prior to elective surgical procedure and then a second blood draw on the morning of the procedure to test apixaban plasma and anti-Xa levels.
15993879|NCT02935738|Drug|Prednisolone treatment|Infertile men were treated with prednisolone tablet, which is an intermediate acting corticosteroid, po, for 21 days of their wife's menstrual cycles. Briefly, the prednisolone regimen was started with a dose of 5mg, tid, for two weeks followed by 5mg bid for five days. This was further tapered to one tablet of 5mg/day for two days. Patients were then given one week of rest from the treatment, before this prednisolone regimen was repeated for another two cycles.
15993880|NCT02935725|Drug|Low dose AUT00206 800mg|
15993881|NCT02935725|Drug|High dose AUT00206 2000 mg|
15993882|NCT02935725|Drug|Placebo|
15993883|NCT02935725|Drug|Ketamine|
15993884|NCT02935725|Other|Saline|
15993885|NCT02935712|Drug|AZD8601+Placebo (SAD)|"Six subjects are randomized to receive one treatment of AZD8601 and one treatment of Placebo.
~Single ascending dose (SAD) with a sequential cohort design and three dose levels of AZD8601 are planned to be investigated. Subjects will receive 0.004 mg per injection of AZD8601/placebo with a total proposed dose of 0.024 mg."
15993886|NCT02935712|Drug|AZD8601+Placebo|Subjects will receive dose with sufficient vascular endothelial growth factor (VEGF)-A protein production and a good safety profile as determined in Part A and the total dose per patient will not exceed the maximum dose given in Part A.
15993887|NCT02935712|Drug|Placebo+Placebo|Subjects are randomized to receive 2 placebo treatments.
15994820|NCT02928679|Drug|Liraglutide 3 mg placebo|
15993888|NCT02935699|Drug|Test Drug (JDP-205)|Cetirizine, 10mg/mL; a single 1.0 mL injection via intravenous (IV) push over a period of ~2 minutes
15993889|NCT02935699|Drug|Active Control (Diphenhydramine)|Diphenhydramine Injection, 50 mg/mL;a single 1.0 mL injection via intravenous (IV) push over a period of ~2 minutes
15993895|NCT02935673|Drug|lumicitabine|Oral administration of lumicitabine as tablet.
15993896|NCT02935673|Drug|Placebo|Oral administration of matching placebo.
15993897|NCT02935660|Device|enLighten Laser|Laser tattoo removal treatment
15993898|NCT02935647|Drug|Diprivan|
15993899|NCT02935634|Biological|Nivolumab|
15993900|NCT02935634|Biological|Ipilimumab|
15993901|NCT02935634|Biological|Relatlimab|
15993902|NCT02935634|Biological|BMS-986205|
15993903|NCT02935634|Drug|Rucaparib|
15993904|NCT02935621|Behavioral|Mindfulness-Oriented Recovery Enhancement (MORE)|Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention that unites mindfulness training, cognitive reappraisal, and positive psychological principles into an integrative intervention strategy targeting mechanisms of pain and opioid misuse.
15993905|NCT02935621|Behavioral|Support Group|A conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.
15993906|NCT02935608|Drug|BIIB074|Administered as specified in the treatment arm
15993907|NCT02935608|Drug|Placebo|Matched placebo
15993908|NCT02935595|Drug|Ketamine|Ketamine Hydrochloride Injection
15993909|NCT02935582|Drug|Enstilar® aerosol foam|Treatment according to local labelling
15993910|NCT02935582|Drug|Other topical|Treatment according to local practise
15993911|NCT02935569|Device|Compression HeadBand|"commercially available office rubber bands (Alliance® Sterling Rubber Bands, Size 105) OR commercially available medical non-latex bands (Allegience® 1 x 18 x .025) with Velcro adhesion
~Plastics disks, hollow (3.5 cm diameter, by 1 cm height)
~Two bands will be placed just behind the ears laterally, and over the occipital protuberance posteriorly. The plastic inserts will be placed in the temporal fossae bilaterally, under the band to provide adequate tension on the temporal artery."
15993912|NCT02935556|Other|no intervention|database and epigenetic study
15993913|NCT02935543|Biological|CART 19|CART19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCRz:41BB administered by IV infusion. Subjects will receive 1-5 x 10^8 transduced CAR T cells as a split dose over three days as follows:Day 1, 10% fraction: 1-5x10^7 CART19 cells, Day 2, 30% fraction: 3x10^7-1.5x10^8 CART19 cells, Day 3, 60% fraction: 6x10^7-3x10^8 CART19 cells
15993914|NCT02935530|Drug|s-LMWH|2125KU, subcutaneous injection of 5-10 days
15993915|NCT02935530|Drug|LMWH|4250KU, subcutaneous injection of 5-10 days
15993916|NCT02935530|Drug|Argatroban|20mg, injection for 5-10 days
15993917|NCT02935517|Biological|AGTC-402|AGTC-402 is a non-replicating, rep/cap-deleted, recombinant adeno-associated virus vector that expresses the CNGA3 gene.
15993918|NCT02935504|Behavioral|PRogram In Support of Moms (PRISM)|"PRISM Intervention Provider and staff training Webinar Delivered in person Engage providers - Registered Nurses (RN) and Patient Care Assistants (PCA) and ensure they attend:
~Toolkit Care coordination Psychiatric consultation Implementation support
~Engage clinic leaders and staff
~Identify leadership group and prepare for change
~Assess readiness to implement PRISM
~Identify steps to achieve goals
~Implement PRISM components into the clinic
~Support, encourage and sustain change Office prompts Screening procedures Plus all MCPAP for Moms intervention"
15993919|NCT02935504|Behavioral|MCPAP for Moms|MCPAP for Moms Provider and staff training Delivered via web RN and PCA admin staff recommended to attend 30-60 minute presentation on perinatal depression Access to telephonic psychiatric consultation with MCPAP for Moms perinatal psychiatrist for Ob/Gyns Access to one-time face-face evaluation with patient by a MCPAP for Moms psychiatrist for assessment and treatment recommendations for Ob/Gyn provider Access to Provider Toolkit which includes assessment and treatment protocols (available at www.mcpapformoms.org) Resource provision/referrals
15993920|NCT02935491|Device|Transcatheter Aortic Valve Implantation (TAVI)|"TAVI is a well-accepted method for aortic valve replacement without surgery. It is currently proposed to patients at high surgical risk or contraindicated to surgery. It consists of introducing a valve inserted inside a stent by the femoral artery in most cases.
~Aortic calcifications will be determined by the analysis of the CT-scan performed systematically before the procedure. A semi-automated software (CreaTools) will be used"
15993921|NCT02935478|Device|Embospheres Microspheres|Via a radial artery in the wrist or the femoral artery in the groin, arterial access will be obtained.Under live X-ray monitoring and using contrast, a catheter will be advanced into the artery of the stomach (left gastric artery). A CT scan will be performed on the X ray table to confirm the placement of catheter. Once this is confirmed small micro spherical particles (Embosphere Microspheres beads) will be injected though the catheter to occlude the artery and cut off blood supply to the stomach. Once the procedure is complete, in case of wrist access compression will be achieved with a band; in case of groin access a closure device will be used to plug the site of entry
15993922|NCT02935465|Behavioral|Mindfulness-Oriented Recovery Enhancement (MORE)|Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention that unites mindfulness training, cognitive reappraisal, and positive psychological principles into an integrative intervention strategy targeting mechanisms of pain and opioid misuse.
15993923|NCT02935465|Behavioral|Support Group|A conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.
15993924|NCT02935452|Behavioral|GENIE - social networking tool|GENIE is a way to help people think about the links they have with others to manage a health problem (local groups, friends, acquaintances, family members, professionals) and to reflect on their involvement in health and wellness activities and their ability to live an ordinary life with a long term condition. By using GENIE and thinking or talking through the GENIE mapping tool, individuals can visualize their network and can reflect on connections that provide value and resources for managing and where there are gaps in support- this might be social, practical or emotional as well as specifically related to a health condition.
15993925|NCT02935439|Other|Cell Phone|Participants responded to questions about their heart failure symptoms using a cell phone.
15993926|NCT02935426|Device|n-butyl cyanoacrylate and 2-octyl cyanoacrylate|used in cyanoacrylate group
15993927|NCT02935426|Device|5-0 Polytetrafluoroethylene (PTFE) suture|used in suture group
15993928|NCT02935413|Device|tDCS|Device: verum tDCS real transcranial direct current stimulation,10 sessions, 2mA for 20 minutes Behavioral: VRT Vision restoration training, 10 sessions, 20 minutes
15993929|NCT02935413|Behavioral|Standard rehabilitation|Standard rehabilitation procedures involving PC-based training of saccades and visual exploration
15993930|NCT02935400|Drug|Hemin|Hemin will be administered under a separate protocol or for clinical treatment, and samples will be collected under this protocol before and after treatment.
15993931|NCT02935387|Other|Taper|Taper
15993932|NCT02935374|Drug|Amoxicillin|The children with acute otitis media will be treated with amoxixillin mixture, 100mg/ml, 40mg/kg/d, divided to two daily doses for 7 days.
15993933|NCT02935374|Drug|Amoxicillin-Potassium Clavulanate|The children with acute otitis media will be treated with amoxixillin-clavulanate mixture, 80mg/ml, 45mg/kg/d, divided to two daily doses for 7 days.
15993934|NCT02935374|Drug|Macrolide|The children with acute otitis media with a know allergy to amoxicillin or amoxicillin-clavulanate will be treated with macrolide and monitored separately
15993935|NCT02935361|Drug|Atezolizumab|Given IV
15993936|NCT02935361|Drug|Guadecitabine|Given SC
15993937|NCT02935348|Radiation|Whole Body MRI|Routine whole body clinical MRI will be performed according to current clinical standard of care. Axial and coronal imaging from the maxilla to proximal femurs will be performed using a combination of T1 and T2 weighted sequences, with and without gadolinium administration.
15993938|NCT02935335|Drug|Menotrophin|
15993939|NCT02935322|Drug|0.12 % chlorhexidine + 0.2 % NaF mouthrinse|"In study I, subjects were asked to refrain from tooth brushing and interdental cleaning and rinse with 10 ml of the assigned test solution for one minute, twice daily (morning and evening) during 4 days.
~In study II, subjects were asked to rinse with 10ml of the assigned test solution twice daily after tooth brushing during a 6-week period."
15993940|NCT02935322|Drug|0.2 % NaF mouthrinse|"In study I, subjects were asked to refrain from tooth brushing and interdental cleaning and rinse with 10 ml of the assigned test solution for one minute, twice daily (morning and evening) during 4 days.
~In study II, subjects were asked to rinse with 10ml of the assigned test solution twice daily after tooth brushing during a 6-week period."
15993941|NCT02935322|Drug|0.12% chlorhexidine|"In study I, subjects were asked to refrain from tooth brushing and interdental cleaning and rinse with 10 ml of the assigned test solution for one minute, twice daily (morning and evening) during 4 days.
~In study II, subjects were asked to rinse with 10ml of the assigned test solution twice daily after tooth brushing during a 6-week period."
15993942|NCT02935322|Other|Placebo|"Contained all basic ingredients as the other three mouthrinses but no chlorhexidine and no NaF. In study I, subjects were asked to refrain from tooth brushing and interdental cleaning and rinse with 10 ml of the assigned test solution for one minute, twice daily (morning and evening) during 4 days.
~In study II, subjects were asked to rinse with 10ml of the assigned solution twice daily after tooth brushing during a 6-week period."
15993943|NCT02935309|Drug|Lenvatinib|Pre-surgery Lenvatinib, days 1 - 5. Dose Escalation Levels: 1.) 10 mg by mouth (PO) daily (QD); 2.) 14 mg PO QD; 3.) 20 mg PO QD; 4.) 24 PO QD.
15993944|NCT02935309|Drug|Capecitabine|Pre-surgery Capecitabine, 850 mg/m^2, twice a day (BID) on days 1-5 for 5½ -6 weeks.
15993945|NCT02935309|Radiation|External Radiation Therapy (XRT)|Pre-surgery RT: Participants will receive 6 weeks of radiation therapy. The radiation sessions will be daily, Monday through Friday, except for holidays.
15993946|NCT02935296|Behavioral|Integrated Intervention|systems navigation, psychosocial counseling
15993947|NCT02935283|Procedure|MRI|MRI, fMRI, 1H MRS, DTI
15993948|NCT02935283|Behavioral|Behavioral|Battery of executive function tasks
15993949|NCT02935257|Biological|CD19CAT-41BBZ CAR T-cells|Infusion with CD19CAT-41BBZ CAR T-cells
15993950|NCT02935231|Drug|Nicotine Replacement Therapy (NRT)|1-week free NRT (gum/patch) plus a card containing instruction and potential side effects.
15993951|NCT02935231|Behavioral|Minimal Cessation Advice (MCA)|Brief smoking cessation advice using AWARD model. AWARD: (1) Ask smoking habit; (2) Warn about smoking risk; (3) Advice to quit as soon as possible; (4) Refer to smoking cessation service; and (5) Do-it-again: if relapse/fail.
15993952|NCT02935231|Other|Health warning leaflet|An A4 double-side color leaflet containing shocking pictures of diseases associated with smoking.
15993953|NCT02935218|Behavioral|Parenting Skills for Mothers with BPD|The cognitive-behavioral Group Training for mothers with BPD consists of 12 weekly sessions promoting parenting skills including primary needs of children, stress and stress management, dealing with conflicts, mindfulness, emotion regulation, routine and flexibility, the role of the body in parenting, basic assumptions about parenting, and self-care.
15993954|NCT02935205|Drug|Enzalutamide|Given PO
15993955|NCT02935205|Drug|Indomethacin|Given PO
15993956|NCT02935192|Biological|Vaccine|Seasonal trivalent split, inactivated influenza vaccine 15 mcg hemagglutinin antigen (HA) of each of A/H1N1; A/H3N2 and B strains; 0.5 mL by IM injection
15993957|NCT02935192|Other|Placebo|Phosphate buffered saline, 0.5 mL by IM injection
15993958|NCT02935179|Dietary Supplement|White sweet potato diet|The diet were supplied 516 kcal daily
15994004|NCT02934789|Drug|Medical therapy|Medical therapy for patients with abnormal uterine bleeding/ heavy menses and submucosal fibroids.
15994094|NCT02934113|Behavioral|iOTA|The Individual Obesity Treatment Approach (iOTA) will assess individual behavior risks, collaborative goal-setting with a health coach, and the use of an interactive text system to provide ongoing support and self-monitoring of behavior change goals.
15993959|NCT02935166|Other|Respiratory muscle training|General high-intensity training consists in maximum effort intervals of 30 seconds duration against an equivalent resistance 0.075 kg / kg of body mass followed by a recovery period of 4 minutes cycle ergometer; the total duration was 3 weeks. They were made in this regard, five weekly sessions of 30 minutes per session, Additionally, randomly, the patients were divided into one of 3 possible groups of respiratory training, which consisted of 5 sets of 10 full breaths (inspiration and expiration) in the morning and afternoon during 3 weeks.
15993960|NCT02935153|Biological|Anti-CD22-CAR-transduced T cells|The first 3 enrolled patients will receive autologous-derived CD22-targeted CAR-T cells on day 1, 2 and 3 with respective 10%, 30% and 60% of the total expected dosage after receiving lymphodepleting chemotherapy. If the 3 patients don't display severe toxicity, the next patients enrolled will get infused in 2 days with respective 40% and 60% total dosage.
15993961|NCT02935127|Procedure|Absorbable suture|Vascular anastomoses will be performed with absorbable materials
15993962|NCT02935127|Procedure|Non-Absorbable suture|Vascular anastomoses will be performed with non-absorbable materials
15993963|NCT02935114|Drug|37% Carbamide Peroxide|"no Gingival dam protection (as manufacturer´s instruction)
~37% Carbamide Peroxide application (2 sessions of 45 minutes)
~Tooth sensitivity (Verbal and visual scale) and color evaluation"
15993964|NCT02935114|Drug|35% hydrogen Peroxide|"Gingival dam protection (as manufacturer´s instruction)
~35% Hydrogen Peroxide application (2 sessions of 45 minutes)
~Tooth sensitivity (Verbal and visual scale) and color evaluation"
15993965|NCT02935101|Drug|Prednisolone|formulated for oral administration. encapsulated.
15993966|NCT02935101|Drug|Placebo (for Prednisolone)|Sugar pill manufactured to mimic Prednisolon 10mg capsules
15993967|NCT02935088|Device|Fractional Flow Reserve|Measurement of physiologic parameters
15993968|NCT02935075|Drug|Tenofovir disoproxil fumarate|Oral daily
15993969|NCT02935075|Drug|Lamivudine|Oral daily
15993970|NCT02935075|Drug|Efavirenz|Oral daily
15993971|NCT02935062|Behavioral|Traditional Phonological Therapy|Phonological therapy based on generalizing the sounds presented by figures, repetition and naming words.
15993972|NCT02935062|Behavioral|Software Phonological Therapy- SIFALA|The phonological thearapy of this group will be based on software use with phonological model already developed, using naming and repetition of sounds.
15993973|NCT02935062|Behavioral|Placebo Therapy|No intervention to improve speech.
15993974|NCT02935049|Procedure|Endoscopic resection|Endoscopic resection with technique EMR piecemeal or hybrid technique EMR/ESD
15993975|NCT02935036|Drug|ADPS topical product|topical product
15993976|NCT02935036|Drug|Placebo Control|topical product
15993977|NCT02935023|Radiation|CIRT with systemic therapy arm|carbon ion radiotherapy to the prostate(59.2GyE/16Fx to prostate and seminal vesicle) Systemic therapy:Hormonal therapy (LHRH agonist and/or antiandrogens) or chemotherapy
15993978|NCT02935010|Drug|Esomeprazole|proton pump inhibitor
15993979|NCT02935010|Drug|Bismuth Potassium Citrate|Gastric mucosal protective drug with anti-H. pylori effect
15993980|NCT02935010|Drug|Amoxicillin|antibiotic for H. pylori eradication
15993981|NCT02935010|Drug|Clarithromycin|antibiotic for H. pylori eradication
15993982|NCT02935010|Drug|Metronidazole|antibiotic for H. pylori eradication
15993983|NCT02935010|Drug|Levofloxacin|antibiotic for H. pylori eradication
15993984|NCT02934997|Other|Observational study|
15993985|NCT02934958|Behavioral|Colon Cancer Screening Navigation|Patients with FIT Positive results that have been given the choice will be followed and navigated from referral to colonoscopy to assist in obtaining colonoscopy.
15993986|NCT02934958|Behavioral|Standard of Care|Patients will be tracked to compare how effective are usual care methods
15993987|NCT02934945|Drug|budesonide 160μg/formoterol 4.5μg|SMART regimen
15993988|NCT02934932|Drug|Brexpiprazole|Comparison of brexpiprazole 2mg to placebo Comparison of brexpiprazole 4mg to placebo
15993989|NCT02934919|Drug|Nalmefene|30 patients with ICDs, will be treated with 18 mg per day of nalmefene during 3 months
15993990|NCT02934906|Procedure|Standard clinical treatment, including intravenous immunoglobulin and/or platelet transfusion|Observational study.
15993991|NCT02934893|Other|Medication Management Clinic|referral to medication management clinic from primary care
15993992|NCT02934893|Other|Diabetes+Me plus connected glucometer|Use of software and medication modeling tool as add on to medication management standard of care
15993993|NCT02934880|Other|immediate APA program|10 sessions of one hour APA in 5 weeks after patient randomization. 2 sessions per week will be organized
15993994|NCT02934880|Other|delayed APA program|10 sessions of one hour APA in 5 weeks 3 months after patient randomization. 2 sessions per week will be organized
15993995|NCT02934867|Other|Protocol phone advice|Protocol phone advice
15993996|NCT02934867|Other|Usual phone advice|Usual phone advice
15993997|NCT02934841|Drug|Conbercept|
15993998|NCT02934841|Drug|sham|
15993999|NCT02934828|Drug|Neoadjuvant Chemotherapy|Neoadjuvant Chemotherapy: TNBC:paclitaxel (PTX) 175mg/m2 d1, Carboplatin area under the curve（AUC4） d2, q14d*6. HER-2 Positive BC: PTX 175mg/m2 d1, Carboplatin AUC4 d2, q14d*6, and plus Herceptin 2mg/kg qw, 6mg/kg q3w after chemotherapy until 1 year.
15994000|NCT02934828|Drug|postoperative chemotherapy|postoperative chemotherapy: EC-P/D±H, paclitaxel and Carboplatin plus Herceptin(TCH）, EC/TC±H, and so on.
15994001|NCT02934815|Other|Supportive-expressive group therapy|The supportive-expressive group therapy (SEGT) is an intervention for women with BC that is designed to build bonds and to facilitate changes in emotional expression and regulation taking into account the role that emotions play in physiologic function, intimately related to the progression of the disease. It is based on seven main themes: building bonds, expressing feelings, detoxifying dying, reordering life priorities, improve support from and communication with family and friends, fortifying families, dealing with doctors, and control pain and anxiety. Although originally developed according to an existential perspective, recently the supportive-expressive group therapy has been used according to an attachment framework.
15994002|NCT02934802|Device|Total Knee prothesis e motion PS Pro|
15994003|NCT02934789|Procedure|Hysteroscopic myomectomy with Truclear|Hysteroscopic myomectomy with Truclear done on patients with abnormal uterine bleeding and submucosal fibroid(s).
15994087|NCT02934165|Behavioral|Family Safety 123|Theoretically-based injury prevention videos for families
15994005|NCT02934776|Device|MRI machine|The Philips Ingenia 3.0T is an MRI machine intended to be used by specialist radiologists in the hospital. It is able to acquire high quality images of wide variety of organs. For imaging the prostate, T2-weighted turbo spin-echo images are normally obtained in three orthogonal planes (axial, sagittal and coronal). This device is been clinically used in the MRI department in Belinson hospital.
15994006|NCT02934763|Drug|Propranolol|propranolol iv by target controlled infusion, to achieve specific plasmatic concentration goals
15994007|NCT02934763|Drug|Saline|Saline as placebo
15994008|NCT02934750|Behavioral|Pursed lip breathing|"Pursed lip breathing will be taught to the participants following the chronic obstructive pulmonary disease (COPD) Foundation recommendations:
~Breathe in through your nose (as if you are smelling something) for about 2 seconds.
~Pucker your lips like you're getting ready to blow out candles on a birthday cake.
~Breathe out very slowly through pursed-lips, two to three times as long as you breathed in.
~Repeat."
15994009|NCT02934737|Other|Progression of diabetes|
15994010|NCT02934724|Procedure|Self sample from vagina|Self sample using The Rover's Evalyn Brush
15994011|NCT02934724|Procedure|Self sample from the oral cavity|Self sample using COPAN FloqSwab
15994012|NCT02934724|Other|Questionnaire|Questionnaire about vaccination status and sexual behaviour
15994013|NCT02934698|Drug|Ivacaftor|Subjects will be treated with ivacaftor for 6 months and followed for 7 months and will undergo assessments along the way to measure sweat chloride and sputum amounts.
15994014|NCT02934685|Radiation|hypofraction|70 Gy in 28 fractions over 5.6 weeks
15994015|NCT02934685|Radiation|convention|80Gy in 40 fractions over 8 weeks
15994016|NCT02934672|Other|Survey|Internet panelists, who self-reported that they or another adult in their household has osteoarthritis, were sent an email invitation to the survey site.
15994017|NCT02934659|Device|Atlas(TM) Knee System|The Atlas System is an extra-capsular knee implant designed to unload the medial knee.
15994018|NCT02934646|Device|Robotic treatment|Passive/active elbow mobilizzation provided by NEUROExos Elbow Module Robotic device
15994019|NCT02934633|Behavioral|Keeping Baby Safe 2-DVD package|Keeping Baby Safe is a 2-DVD package that teaches childhood injury prevention skills to parents of children from birth to 24 months of age. One DVD addresses automobile passenger safety and focuses on the correct choice and proper installation of child safety seat for the age of the parent's child. The second DVD covers a core set of home safety skills: (a) preventing falls, (b) preventing fires and burns, (c) preventing poisoning, (d) firearm safety, (e) preventing drowning, (f) preventing suffocation and choking, (e) play equipment safety, and (f) animal safety. Content in the home safety DVD is based on information the American Academy of Pediatrics (AAP) recommends that physicians provide to parents during well-baby visits.
15994020|NCT02934633|Behavioral|The Injury Prevention Program (TIPP) sheets|American Academy of Pediatrics The Injury Prevention Program (TIPP) sheets. Paper-based information sheets parents would typically receive from their pediatrician or general practitioner at well-baby visits.
15994021|NCT02934620|Device|CSD500 Condom|CSD500 is a commercial condom that complies fully with the requirements of ISO 4074, the international standard for male latex condoms. The product is designed to increase sexual pleasure.
15994022|NCT02934620|Device|Standard Condom|The standard condom is a standard condom in Vietnam at the time of the study. It is provided for pregnancy and disease prevention.
15994023|NCT02934620|Behavioral|Condom Counseling|The intervention arm will receive counseling that briefly addresses condom's dual protection against pregnancy and HIV/STI but that otherwise emphasizes the potential for increased sexual pleasure with CSD500 use. Counseling to this arm also will include CSD500-specific instructions, such as the need to briefly massage the gel inside the condom teat onto the penis head after donning the condom and to not use multiple condoms within a 24-hour period. The control arm will receive standard counseling to use condoms for pregnancy and disease prevention without receiving any messages about the use of condoms for sexual pleasure.
15994024|NCT02934607|Drug|Symbicort pMDI with spacer device|Relative bioavailability of budesonide and formoterol delivered via Symbicort pressurized metered-dose inhaler (pMDI) with a spacer device (test)
15994025|NCT02934607|Drug|Symbicort pMDI without spacer device|Relative bioavailability of budesonide and formoterol delivered via Symbicort pMDI without a spacer device (reference)
15994026|NCT02934594|Other|Palliative Decompression|palliative decompression to MSCC patients: before motor deficit (Group A), within 48 hours after motor deficit (Group B1), 48 hours after motor deficit (Group B2)
15994027|NCT02934568|Drug|LEE011|Single agent LEE011 or in combination with other treatments
15994028|NCT02934555|Drug|Ubiquinol|300 mg Ubiquinol (3 mL liquid Ubiquinol).
15994029|NCT02934555|Dietary Supplement|Ensure|50 mL Ensure
15994030|NCT02934542|Device|AutoLap system|
15994031|NCT02934529|Drug|Irinotecan|Irinotecan 180 mg/m² iv, 30 - 90 min., day 1, q d15
15994032|NCT02934529|Drug|Folinic Acid|Folinic acid (racemic) 400 mg/m² iv, 120 min. day 1, q d15
15994033|NCT02934529|Drug|5-FU|5-FU 400 mg/m² bolus day 1, q d15
15994034|NCT02934529|Drug|5-FU|5-FU 2400 mg/m² iv over 46 h day 1-2, q d15
15994035|NCT02934529|Drug|Cetuximab|cetuximab initially 400 mg/m² as a 120 min. infusion (≤ 5mg/min); subsequently 250 mg/m² iv respectively as a 60 min. infusion (≤ 10mg/min) day 1 + 8
15994036|NCT02934529|Drug|Bevacizumab|Bevacizumab 7.5 mg/kg BW iv over 30 to 90 minutes: day 1
15994037|NCT02934529|Drug|Capecitabine|Capecitabine 1250 mg/m2 2 x day p.o. day 1-14, q d15
15994038|NCT02934529|Drug|regorafenib|160 mg per day (day 1-21) (repeated on day 28)
15994039|NCT02934529|Drug|Irinotecan 125mg|Irinotecan 125 mg/m² iv, 60 - 90 min. weekly (D1, D8, D15, D22)
15994040|NCT02934529|Drug|Cetuximab wkly|Cetuximab initially 400 mg/m² as a 120 min. infusion (≤ 5mg/min); subsequently 250 mg/m² iv respectively as a 60 min. infusion (≤ 10mg/min) weekly (D1, D8, D15, D22, D29, D36)
15994088|NCT02934165|Behavioral|AAP TIPP sheets|American Academy of Pediatrics The Injury Prevent Program materials converted to web-based materials.
15994089|NCT02934152|Drug|H pylori eradication|H pylori eradication
15994090|NCT02934152|Other|H pylori eradication timing|Early or late eradication
15994091|NCT02934139|Drug|Cavosonstat|CFTR modulator that stabilizes CFTR
15994092|NCT02934139|Other|Placebo|Matched placebo
15994093|NCT02934126|Other|breast cancer patients|semi structured face to face interviews
16011827|NCT02798510|Drug|gemcitabine|
15994041|NCT02934516|Procedure|Cesarean section|"Abdominal disimpaction with lower uterine segment support: the edge of the lower uterine segment is grasped by 3-4 modified Allies forceps (with broader jaws) applied along the lower edge of the incision until it is completely supported. These forceps are handled by the assistant, and gentle traction is applied upward, perpendicular to the uterine surface and away from the fetal head without excessive force. Accordingly, the hand of the surgeon could be inserted into the uterine cavity, and adequate space for manipulations is available without applying pressure on the lower segment. The fetal head is eventually grasped and delivered.
~Classic push method: delivering the head with assistance by pushing the fetal head vaginally"
15994042|NCT02934503|Biological|Pembrolizumab|200 mg IV fixed dose every 3 weeks until progression or for up to 2 years of therapy.
15994043|NCT02934503|Drug|Cisplatin|75 mg/m2
15994044|NCT02934503|Drug|Carboplatin|AUC 6
15994045|NCT02934503|Drug|Etoposide|IV every 3 weeks for up to 6 cycles (minimum of 4 cycles, maximum of 6).
15994046|NCT02934503|Radiation|Radiation therapy|Thoracic radiotherapy will be given per institutional standards(dose and duration may vary for individual participants).
15994047|NCT02934490|Device|Mesh|Meshes were made by Gynemech TM PS, (Johnson & Johnson Shanghai Medical Equipment Co. SFDA registration No. 3460365, size 10 × 15cm)
15994048|NCT02934477|Other|Hematopoietic Stem Cell Transplant|This observational study will compare outcomes of prospectively enrolled HCT recipients with outcomes of a cohort of age-matched non-HCT controls.
15994049|NCT02934464|Drug|RAMUCIRUMAB|
15994050|NCT02934464|Drug|Paclitaxel|Paclitaxel
15994051|NCT02934464|Drug|FOLFOX 4|
15994052|NCT02934464|Drug|mFOLFOX 6|
15994053|NCT02934464|Drug|XELOX|
15994054|NCT02934438|Dietary Supplement|Neo40|
15994055|NCT02934438|Dietary Supplement|Placebo|
15994056|NCT02934425|Other|Refined carbohydrate-rich breakfast|Refined carbohydrate-rich breakfast containing approximately 8/66/26% kcal from protein/carbohydrate/fat, respectively
15994057|NCT02934425|Other|High pork protein breakfast|High pork protein breakfast containing approximately 35/39/26% kcal from protein/carbohydrate/fat, respectively
15994058|NCT02934412|Drug|SHR-1314|Single subcutaneous injection of SHR-1314 at 5 dose levels (20mg, 40mg, 80mg, 160mg, and 240mg) in healthy subjects.
15994059|NCT02934412|Drug|placebo|Single subcutaneous injection of placebo at 5 dose levels (20mg, 40mg, 80mg, 160mg, and 240mg) in healthy subjects.
15994060|NCT02934399|Other|27 hour subcutaneous fluid sampling|"One hour prior to the microdialysis catheter insertion the participants will be asked to receive a local anaesthetic on the injection site for the microdialysis catheter. Lignocaine 1% will be injected subcutaneously at a localised site on the abdomen covering a horizontal area of about 5cm after a brief acclimatisation period at the hospital.
~A sterile linear catheter will be inserted using aseptic precautions at the anaesthetised site on the abdomen. The catheter is connected at one end to the microdialysis pump, and at the other end to the automated collection device. Subcutaneous tissue microdialysis samples will be collected regularly for the duration of the sampling period (27 hours)."
15994061|NCT02934386|Device|WinMedical WinPack device|
15994062|NCT02934373|Device|A New Sound Processor|
15994063|NCT02934360|Device|TR(ACE) Assay Testing|Serial plasma testing with TR(ACE) Assay
15994064|NCT02934347|Procedure|25 degree back-up position|To test whether a 25 degree back-up position improves laryngeal views and makes intubation easier compared to the standard horizontal position
15994065|NCT02934334|Other|Observational|
15994066|NCT02934321|Dietary Supplement|Erythritol|Erythritol is a well tolerated, low calorie sugar alcohol that is becoming more widely used as a sugar substitute.
15994067|NCT02934321|Dietary Supplement|Aspartame|Aspartame is a well tolerated, commonly used artificial sweetener.
15994068|NCT02934308|Device|Skin Conductance Monitor|
15994069|NCT02934295|Biological|Determination of Anti-Rubella Antibody, E1|
15994070|NCT02934282|Drug|HBOC-201|Hemoglobin Based Oxygen Carrier (HBOC)
15994071|NCT02934269|Drug|Placebo|
15994072|NCT02934269|Drug|CC-90006|
15994073|NCT02934256|Drug|Icotinib|Method of drug administration:oral; Dosage: 125mg/m3/d; Course of treatment: 3 months;Total four treatment courses.
15994074|NCT02934243|Device|laryngeal mask insertion|airway management with laryngeal mask
15994075|NCT02934230|Behavioral|Prehabilitation Program|"Strength training: This component consists of 1 set of 10 repetitions of each exercise: a. push-ups (modified to the individual's level of function as either wall push-ups, knee push-ups, or full push-ups); b. seated row (performed with an elastic resistance band); c. chest fly (performed with an elastic resistance band); d. deltoid lift (performed with an elastic resistance band); e. biceps curls (performed with an elastic resistance band); f. triceps extensions (performed with an elastic resistance band); g. chair squats; h. hamstring curls; i. standing calf raises; j. abdominal crunches (modified to be performed seated in a chair)
~Aerobics: Walking for 20 minutes at moderate intensity.
~Flexibility: Chest, arm, leg and truck stretches, with each stretch to be held for 20 seconds, done for 2 repetitions."
15994076|NCT02934217|Drug|Injection of Cyclosporin|one single intravenous bolus injection of 2.5 mg/Kg
15994077|NCT02934217|Drug|Placebo|One single intravenous bolus injection of Placebo
15994078|NCT02934217|Procedure|Echocardiography|3 years after AMI
15994079|NCT02934204|Drug|methotrexate|
15994080|NCT02934204|Drug|temozolomide|
15994081|NCT02934191|Drug|Celecoxib|Dosing will be 6mg/kg twice a day with a maximum dose of 300mg twice a day. All ages will be given the suspension (concentration 100mg/5mL) orally
15994082|NCT02934191|Other|Placebo|Placebo will have the same appearance, taste and consistency as celecoxib. Placebo will consist of calcium carbonate powder suspended in the same syrup as celecoxib. Dose of elemental calcium is 3 mg/kg/day.
15994083|NCT02934191|Drug|Acetaminophen|Acetaminophen syrup at a dose of 15mg/kg/dose will be given every 4 hours for the first 5 days after surgery. After that point, is given as needed.
15994084|NCT02934191|Drug|Oxycodone|Oxycodone may be used every 4 hours post-operatively to treat breakthrough pain. The most commonly prescribed dose is 0.075mg/kg/dose (suspension) every 4 hours as needed.
15994085|NCT02934178|Biological|Shigella sonnei Strain WRSS1 Vaccine|Live attenuated, oral Shigella WRSS1 vaccine
15994086|NCT02934178|Biological|Placebo|Sterile saline solution
16012480|NCT02793765|Biological|Sipuleucel-T|
15994095|NCT02934113|Behavioral|HWPP|Work groups will participate in the Healthy Workplace Participatory Program (HWPP) to adapt and deploy interventions that change their work environments to support healthy eating and physical activity.
15994096|NCT02934100|Device|Shock Master 300|"Extracorporeal Shock Wave Therapy
~In all treatments (from 1 to 10) applied number of pulses is 4500 and the frequency is based on the patients feelings (from 8 to 12 Hz). Variable is the pressure:
~Treatment 1 - 2,5 Bar; Treatment 2 - 2,6 Bar; Treatment 3 - 2,7 Bar; Treatment 4 - 2,8 Bar; Treatment 5 - 3,0 Bar; Treatment 6 - 3,2 Bar; Treatment 7 - 3,4 Bar; Treatment 8 - 3,6 Bar; Treatment 9 - 3,8 Bar; Treatment 10 - 4,0 Bar.
~Each patient will also receive kinesiotherapy treatment that will consist of:
~eight-minute massage of posterior lower leg muscles
~plantar aponeurosis stretching"
15994097|NCT02934100|Device|Skanlab 25 BODYWAVE|"Electric field diathermy therapy - Capacitive energy transfer system (CETS)
~Time of each treatment (from 1 to 15) is eight minutes. Variable is the energy:
~Treatment 1 - 3; Treatment 2 - 3; Treatment 3 - 4; Treatment 4 - 4; Treatment 5 - 5; Treatment 6 - 5; Treatment 7 - 6; Treatment 8 - 6; Treatment 9 - 7; Treatment 10 - 7; Treatment 11 - 7; Treatment 12 - 7; Treatment 13 - 7; Treatment 14 - 7; Treatment 15 - 7.
~Each patient will also receive kinesiotherapy treatment that will consist of:
~eight-minute massage of posterior lower leg muscles
~plantar aponeurosis stretching"
15994098|NCT02934100|Device|EVO US13 CosmoGamma|"Ultrasound therapy
~Doses applied as following:
~Each treatment (from 1 to 15) is pulsed ultrasound (1MHz, pulsed 1:4). Variable is the time and intensity:
~Treatment 1 - 4 minutes, 0,4 W/cm2; Treatment 2 - 5 minutes, 0,4 W/cm2; Treatment 3 - 5 minutes, 0,5 W/cm2; Treatment 4 - 6 minutes, 0,5 W/cm2; Treatment 5 - 6 minutes, 0,6 W/cm2; Treatment 6 - 6 minutes, 0,6 W/cm2; Treatment 7 - 6 minutes, 0,6 W/cm2; Treatment 8 - 6 minutes, 0,7 W/cm2; Treatment 9 - 7 minutes, 0,7 W/cm2; Treatment 10 - 7 minutes, 0,7 W/cm2; Treatment 11 - 7 minutes, 0,8 W/cm2; Treatment 12 - 8 minutes, 0,8 W/cm2; Treatment 13 - 8 minutes, 0,8 W/cm2; Treatment 14 - 8 minutes, 0,8 W/cm2; Treatment 15 - 8 minutes, 0,8 W/cm2.
~Each patient will also receive kinesiotherapy treatment that will consist of:
~eight-minute massage of posterior lower leg muscles
~plantar aponeurosis stretching"
15994099|NCT02934100|Device|Sham LASER CTL1106MX|"Sham laser therapy Time of each treatment (from 1 to 15) is four to five minutes. Developed is 10 points, each point takes 15 seconds. Device is unplugged and it does not emit any radiation.The patient does not know that the procedure is not really executed.
~Each patient will also receive kinesiotherapy treatment that will consist of:
~eight-minute massage of posterior lower leg muscles
~plantar aponeurosis stretching"
15994100|NCT02934087|Procedure|Endovascular Aneurysm Repair|Endovascular aneurysm repair (or endovascular aortic repair) (EVAR) is a type of endovascular surgery used to treat pathology of the aorta, most commonly an abdominal aortic aneurysm (AAA)
15994101|NCT02934074|Other|No intervention|
15994102|NCT02934061|Device|Tizaspray® administered intranasally|0,5 mg Tizaspray® administered intranasally
15994103|NCT02934061|Drug|Sirdalud® 2 mg tablets administered|Sirdalud® 2 mg tablets administered in patients with acute low back pain
15994104|NCT02934048|Other|7-day triple regimen guided by AST|Patients in this group will receive a 7-day triple regimen to eradicate H. pylori. The regimen is consist of a PPI and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated.
15994105|NCT02934048|Other|10-day triple regimen guided by AST|Patients in this group will receive a 10-day triple regimen to eradicate H. pylori. The regimen is consist of a PPI and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated.
15994106|NCT02934048|Other|14-day triple regimen guided by AST|Patients in this group will receive a 14-day triple regimen to eradicate H. pylori. The regimen is consist of a PPI and 2 susceptible antibiotics which are determined by AST. The susceptibility of amoxicillin, clarithromycin, metronidazole, tinidazole,levofloxacin, furazolidone and tetracycline will be evaluated.
15994107|NCT02934035|Drug|Antidepressant|
15994108|NCT02934022|Drug|Maraviroc|150 mg tablets, two or 4 tablets once daily (dependent upon concommitant medications)
15994109|NCT02934009|Device|Dermal nuclear magnetic resonance (NMR)-profile measurement|Nuclear magnetic resonance (NMR)-profile measurement of the dermis
15994110|NCT02933996|Device|TEAS+GA group|The acupoints including Zusanli and Shenshu, were identified before electrical stimulation with surface electrodes. Selection of these acupoints was based on a consensus between the acupuncturists of the study.
15994111|NCT02933996|Device|Sham TEAS+GA group|No electrical stimulation sensation is performed in the Sham TEAS group. In the Sham TEAS group, pseudo-stimulation is provided by deliberately connecting the electrodes to the incorrect output socket of the electroacupuncture device, and thus there is no flow of electric current. Patients could see the output light flashing but no current was transmitted throughout the procedure. Patients would be told that the stimulation frequency selected was not perceivable by human beings.
15994112|NCT02933983|Other|no intervention, compare URT microbiome healthy control group-chronic rhinosinusitis patients|
15994113|NCT02933970|Other|Telemedicine|Patients will be linked with the provider via two-way video-teleconferencing facilitated by an onsite OAT program staff member
15994114|NCT02933944|Biological|TG02-treatment|
15994115|NCT02933944|Drug|Pembrolizumab|
15994116|NCT02933918|Other|Probiotics|Safety of nasal irrigation with probiotics in healthy volunteers
15994117|NCT02933905|Drug|Intravitreal Ranibizumab injection|
15994118|NCT02933892|Procedure|Cardiac Catheterization|Cardiac catheterization is a diagnostic procedure used to treat and diagnose heart conditions.
15994119|NCT02933879|Drug|NVXT topical|topical treatment
15994120|NCT02933879|Drug|Placebo (Vehicle) Topical|Placebo (Vehicle) Topical
15994121|NCT02933866|Drug|DSXS topical|topical treatment
15994122|NCT02933866|Drug|Vehicle topical|topical treatment
15994123|NCT02933853|Drug|Faster-acting insulin aspart|A single dose administered subcutaneously (s.c., under the skin). The dose level will be 0.3 U/kg body weight.
15994124|NCT02933853|Drug|Insulin Aspart|A single dose administered subcutaneously (s.c., under the skin). The dose level will be 0.3 U/kg body weight.
15994258|NCT02932852|Procedure|Transplantation|The ophthalmologist will carry out the transplantation of the ADAS cells with or without scaffold in the intrastromal cornea of the patient
15995136|NCT02926352|Device|Sham Low-Level Laser Therapy|Placebo dose version of LLLT.
15994125|NCT02933840|Device|AlertWatch|AlertWatch holds 510(k) FDA clearance K15335. It is a software program that takes data present in the medical record, including vital signs and laboratory results, and determines whether it meets predetermined thresholds for alerting a clinician. These thresholds are intended to correlate with signs of acute clinical deterioration in the patient being monitored.
15994126|NCT02933827|Drug|ELIXCYTE|Adipose-derived stem cells (ADSCs)
15994127|NCT02933814|Drug|Liposomal Bupivicaine|Patients in Group 2 (Liposomal Bupivacaine + Plain Bupivacaine) will be treated intra-operatively with the initial injection of 0.25% bupivacaine 5 - 10 mL (12.5 - 25 mg) delivered to perform a field block of the soft tissue and subfascial plane at the initiation of the procedure.
15994128|NCT02933801|Drug|ODM-201|ODM-201 will be given at a dose of 600 mg BID orally on a continuous basis.
15994129|NCT02933801|Other|Placebo|Placebo will be given at a dose of 600 mg BID orally on a continuous basis.
15994130|NCT02933788|Drug|Cilostazol|Cilostazol sustained release capsule is new drugs developed by Otsuka Korea. This drugs have platelet aggregation inhibiting action, peripheral vasodilating action and endothelial function improving action.
15994131|NCT02933788|Drug|Acetylsalicylic acid|Aspirin may prevent coronary thrombosis in patients with cardiovascular event risk factors, such as ischemic heart disease family history, hypertension, diabetes mellitus, dyslipidemia and obesity.
15994132|NCT02933775|Genetic|CAR-CD19 T cells|Initial dose: A total of 1 - 10×10^7 CAR-CD19 T cells/kg will be administered by 1 - 3 infusions. Subsequent dose will be based on the subject's response to initial dose.
15994133|NCT02933775|Drug|Fludarabine|30 mg/m^2/day×4 days
15994134|NCT02933775|Drug|Cyclophosphamide|500 mg/m^2/day×2 days
15994135|NCT02933762|Drug|JNJ-54175446|Participants will receive a single oral dose of JNJ-54175446 suspension orally once on Day 1 of part 1 and Day 1 to Day 7 in part 2.
15994136|NCT02933762|Drug|Placebo|Participants will receive a single oral dose of JNJ-54175446 suspension orally once on Day 1 of part 1 and Day 1 to Day 7 in part 2.
15994137|NCT02933749|Device|SctO2|The non invasive cerebral oxymetry (INVOS-Covidien) has been used to measure cerebral oxygen saturation.
15994138|NCT02933749|Device|BIS|Bispectral index
15994139|NCT02933736|Drug|Ribociclib|
15994140|NCT02933723|Procedure|Blood Draw|Sampling 3 blood draws Day 0 for humoral and CMI 30 ml prior to vaccination (up to 2 week prior to vaccination) Day 7 for CMI 20 ml (+/- 1 day) Day 28 for humoral 10 ml (+/- 3 days)
15994141|NCT02933697|Drug|Apixaban|Patients will be instructed to take one tablet of 2.5 mg twice daily: one tablet in the morning and one in the evening at approximately the same time every day (with about 12 hours gap) irrespective of the time of dialysis.
15994142|NCT02933697|Drug|Phenprocoumon|Subjects in phenprocoumon treatment group will receive phenprocoumon individually adjusted to an INR of 2.0-3.0 as recommended in the appropriate SmPC for AF patients.
15994143|NCT02933684|Drug|Seromycin|Seromycin (aka D-cycloserine) is an analogue of D-alanine and a partial agonist at the NMDA receptor, which facilitates the process of fear extinction.
15994144|NCT02933684|Behavioral|Virtual Reality Exposure Therapy|Allows for delivery of exposure therapy on an iPad. Participants read a speech to a virtual audience. Exposures become increasingly more difficult as the audience becomes more hostile and speeches increase in length and complexity.
15994145|NCT02933684|Drug|Placebo|Administered in pill form.
15994146|NCT02933671|Procedure|Suprainguinal fascia iliaca (SIFI) block|An ultrasound guided nerve block using a medication that numbs the nerve called ropivacaine.
15994147|NCT02933671|Procedure|Sham block|An ultrasound guided nerve block using a medication that does NOT numb the nerve called saline, or salt water.
15994148|NCT02933671|Drug|Ropivacaine|Local anesthetic (numbing drug)
15994149|NCT02933671|Drug|Saline|Salt water placebo
15994150|NCT02933658|Drug|Telmisartan|
15994151|NCT02933658|Drug|Amlodipine|
15994152|NCT02933658|Drug|Rosuvastatin|
15994153|NCT02933645|Drug|Actrapid|Subjects administer 2 intranasal sprays into each nostril every minute for 4 minutes, a total of 16 sprays or 160 IU of fast-acting human insulin (Actrapid, Novo Nordisk A/S, Bagsvaerd, Denmark). The glass spray flasks are produced by AeroPump GmBH, Germany and give 0,1 ml of fluid per spray.
15994154|NCT02933645|Drug|Placebo|Subjects administer 2 intranasal sprays into each nostril every minute for 4 minutes, a total of 16 sprays. Sprays contain Insulin Diluting Medium for Novorapid and Levemir (Novo Nordisk A/S, Bagsvaerd, Denmark). The glass spray flasks are produced by AeroPump GmBH, Germany and give 0,1 ml of fluid per spray. To account for the small amount of insulin absorbed into circulation after the insulin nasal sprays, on the placebo day subjects will be administered 2.5 mU/kg of additional intravenous insulin (Actrapid, Novo Nordisk A/S, Bagsvaerd, Denmark) over 15 minutes.
15994155|NCT02933645|Radiation|[18F]-FDG PET-CT|All subjects will undergo two positron emission tomography (PET) studies. On both visits they are injected with 185 MBq [18F]-fluorodeoxyglucose and scanned with a combined PET and computed tomography scanner.
15994156|NCT02933645|Drug|Hyperinsulinemic euglycemic clamp|All subjects will undergo two hyperinsulinemic euglycemic clamp studies. The insulin infusion will be administered intravenously at a steady rate of 0.25 mU/kg/min for approximately 170 minutes. Glucose will be administered intravenously as a 200 mg/ml fluid to at varying rate to maintain euglycemia.
15994157|NCT02933632|Other|Physical Therapy-SAP|"Day 1) Patients started approach after discharged anesthesia. Patients received verbal orientation and demonstration of the physiotherapy exercises that would strengthen muscles (gluteal and thigh). They were oriented to the decubitus changes and how to leave bed. They practiced 3 repetitions of 12 complete movements for each exercise;
~Day 2) Patients repeated the exercises learned from day 1. Following the proposed activities patients received verbal instructions on gait training and then starting gait training. Patients started gait training on this second day only if they felt safe and claimed that their pain was controlled. Otherwise, training was postponed to the next day;
~Day 3) Patients repeated the day 2. And the patient who had not started gait training in the day 2, began it on the day 3;
~Day 4 and other days) Patients repeated the gait training until the discharge date."
15994259|NCT02932839|Device|NeuroPort micro-electrode array|Implantation of the Blackrock NeuroPort micro-electrode array for up to 29 days in patients who are undergoing evaluation with intracranial EEG electrodes
15994260|NCT02932826|Biological|Umbilical Cord Blood Regulatory T cells Therapy|Receive Treg infusion: 1~5*10^6/kg b.w. in 100ml NS
16012481|NCT02793752|Other|Age|Maternal Age
15994158|NCT02933632|Other|Physical Therapy-ARP|"Day 1-1°approach) Patients started after discharged anesthesia. Received verbal orientation and demonstration of the physiotherapy exercises that would strengthen muscles (gluteal and thigh). They were oriented to the decubitus changes and how to leave bed. They practiced 3 repetitions of 12 complete movements for each exercise;
~Day 1-2°approach) Patients repeated the exercises learned from day 1-1°approach. Following patients received verbal instructions on gait training and then starting gait training. Patients started gait training on this Day 1-2°approach only if they felt safe and claimed that their pain was controlled. Otherwise, training was postponed to next approach;
~Day 1-3°approach) Patients repeat the day 1-2°approach. And the patient, who had not started gait training in the day 1 - second approach, began it in this third approach;
~Day 2) Patients repeated three times the day 1-3°approach;
~Day 3) Patients repeated three times the day 1-3°approach."
15994159|NCT02933606|Drug|BNC210|
15994160|NCT02933606|Drug|Placebo|
15994161|NCT02933593|Drug|Labetalol|To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously.
15994162|NCT02933593|Drug|Hydralazine|To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously.
15994163|NCT02933593|Drug|nifedipine|To determine which protocol recommended by ACOG for severe hypertension in pregnancy decreases central arterial pressure the fastest, and the most efficaciously.
15994164|NCT02933580|Drug|JNJ-56136379|Participants will receive a single oral dose (tablets) of JNJ-56136379 on Day 1.
15994165|NCT02933580|Other|Placebo|Participants will receive matching placebo tablets on Day 1.
15994166|NCT02933567|Other|CSC OnDemand|CSC OnDemand is a multifaceted online learning product that includes four levels: 1) an online readiness tool and CSC Learning Hub; 2) dynamic multimedia core curriculum on first episode psychosis and CSC; 3) live faculty-led online courses; and 4) ongoing support, including an online community of practice to support peer-to-peer learning.
15994167|NCT02933554|Device|Embospheres Microspheres|Via a radial artery in the wrist or the femoral artery in the groin, arterial access will be obtained.Under live X-ray monitoring and using contrast, a catheter will be advanced into the artery of the stomach (left gastric artery). A CT scan will be performed on the X ray table to confirm the placement of catheter. Once this is confirmed small micro spherical particles (Embopheres Microspheres) will be injected though the catheter to occlude the artery and cut off blood supply to the stomach. Once the procedure is complete, in case of wrist access compression will be achieved with a band; in case of groin access a closure device will be used to plug the site of entry.
15994168|NCT02933528|Drug|DSXS Topical product|once daily for 28 days
15994169|NCT02933515|Other|yoga and occupational therapy|group OT addressed fall risk factors, such as risk factors inside and outside and how to best manage them. yoga was delivered in sitting, standing, and floor postures
15994170|NCT02933502|Drug|DSXS topical product|treatment daily for 28 days
15994171|NCT02933489|Diagnostic Test|Contrast-enhanced Magnetic Resonance Imaging|Undergo AB-MR
15994172|NCT02933489|Diagnostic Test|Digital Tomosynthesis Mammography|Undergo DBT
15994173|NCT02933489|Other|Quality-of-Life Assessment|Ancillary studies
15994174|NCT02933489|Other|Questionnaire Administration|Ancillary studies
15994175|NCT02933476|Device|Vibrotactile Stimulation|The tactile stimulator is being tested for an off-label use as treatment for Parkinson's disease. There are nodes embedded into the fingertips of gloves that gently vibrate in an alternating pattern. The sensation is similar to the feeling of a phone vibrating. This is a non-significant risk device.
15994176|NCT02933463|Other|Embrace Wetbond|not require an additional bonding agent hydrophilic, fluoride releasing
15994177|NCT02933463|Other|Clinpro sealant|
15994178|NCT02933450|Drug|Patiromer 25.2 g|Single dose of Patiromer 25.2 g
15994179|NCT02933437|Drug|Ajmaline|Ajmaline 1milligram/kilogram max dose as bolus intravenous over 10 minutes with continuous ECG monitoring
15994180|NCT02933424|Dietary Supplement|Protein Powder|
15994181|NCT02933411|Other|Genetic Analysis|Blood sample will be drawn to assess the number of participants enrolled that have sequence variation in the von willebrand factor gene and other genes affecting bleeding, clotting and blood vessel biology.
15994182|NCT02933411|Other|Medical Record Data Abstraction|"The subject's response to intranasal or intravenous desmopressin (DDAVP) challenge performed as part of standard of care will be recorded. The desmopressin is a drug that increases the clotting factor in blood to prevent bleeding.
~Medical and family history including and not limited to age, diagnoses, race/ethnicity, lab values, HMB and low VWF activity diagnoses, and treatment history and outcome will also be recorded."
15994183|NCT02933411|Other|Pictorial Blood Assessment Chart (PBAC) score|PBAC is a pictorial tool to assess menstrual blood loss. Study team will complete the PBAC assessment with each study participant evaluating and measure response to different treatments for menstrual blood loss in the clinic setting between those with VWD versus other bleeding disorders.
15994184|NCT02933411|Other|Complete Bleeding Symptom ISTH Bleeding Assessment Tool|Study participants will complete the ISTH BAT assessment. The ISTH BAT is a questionnaire to aid in the standardized evaluation of the presence and severity of bleeding symptoms.
15994185|NCT02933398|Procedure|Robotic Assisted Nephrectomy|Robotic (Davinci)
15994186|NCT02933398|Procedure|Laparoscopic Assisted Nephrectomy|Regular Laparoscopic Technique.
15994187|NCT02933385|Behavioral|Health Risks assessement|Home made questionnaire questioning about the participant's lifestyle habits, risk factors and other.
15994188|NCT02933385|Behavioral|Web-based health discussions|Create interactions between the employees.
15994189|NCT02933385|Behavioral|SOScuisine website|Site that is personalized to the employee. It provides menus, grocery shopping list and other.
15994190|NCT02933385|Behavioral|Health screening|Screen for diabetes, cholesterol, blood pressure and body weight.
15994191|NCT02933385|Behavioral|Closing events|these aim to motivate the employees to continue into the program.
15994192|NCT02933385|Behavioral|Coaching|The first year participant will be coached by a nurse, second year by a nutritionist, and third year by a kinesiologist.
15994193|NCT02933385|Behavioral|Social Health platform|
15994194|NCT02933385|Behavioral|Accelerometer provided|Social Health Platform: employees can challenge themselves or each other.
15994195|NCT02933372|Drug|Varenicline|Participants take varenicline for 10 days. Each participant will be on one dosage throughout the 10 days, but not all participants receive the same dosage. The dosages that were utilized for both Parkinson's disease participants and healthy volunteers were 0.25mg once a day, 0.25mg twice a day, and 0.5mg twice a day. A fourth dosing group of 1 mg varenicline twice a day was studied in Parkinson's disease participants, but not in healthy volunteers.
15994196|NCT02933333|Biological|GM-CSF|Granulocyte-macrophage colony-stimulating factor (GM-CSF) is a hematopoietic CSFs that decrease the duration and severity of neutropenia for patients receiving chemotherapy. GM-CSF is a stimulator of the growth and differentiation of hematopoietic progenitor cells committed to neutrophils, monocytes or eosinophils.
15994197|NCT02933333|Biological|G-CSF|Granulocyte colony-stimulating factor (G-CSF) is a hematopoietic CSFs that decrease the duration and severity of neutropenia for patients receiving chemotherapy. G-CSF is a relatively specific stimulator of the growth and differentiation of hematopoietic progenitor cells committed to the neutrophil lineage.
15994198|NCT02933333|Biological|GM-CSF and G-CSF|Granulocyte-macrophage colony-stimulating factor (GM-CSF) and granulocyte colony-stimulating factor (G-CSF) are hematopoietic CSFs that decrease the duration and severity of neutropenia for patients receiving chemotherapy. GM-CSF and G-CSF share a number of biologic activities, GM-CSF seems to be more potent against fungi.
15994199|NCT02933320|Biological|BI-1206 single agent dose escalation phase|BI-1206 single agent dose escalation phase to determine the MTD or maximum administered dose (MAD) and recommended Phase II dose (RP2D) for evaluation of BI-1206.
15994200|NCT02933320|Biological|Combination of BI-1206 with rituximab escalation phase|An investigation of combination treatment of BI-1206 with rituximab.
15994201|NCT02933320|Biological|BI-1206 single agent expansion phase|BI-1206 single agent expansion phase at the RP2D.
15994202|NCT02933320|Biological|Combination of BI-1206 with rituximab expansion phase|BI-1206 in combination with rituximab at the RP2D.
15994203|NCT02933307|Device|HealthPatch|The HealthPatch (Vital Connect) is a wireless patch and continuously measures single-lead ECG, heart rate, respiratory rate, stress, skin temperature, body posture and steps
15994204|NCT02933307|Device|ViSi Mobile|ViSi Mobile (Sotera Wireless) is wireless device that is able to continuously measure all important vital parameters: ECG, heart rate, oxygen saturation, blood pressure, respiratory rate and skin temperature.
15994205|NCT02933294|Procedure|Triportal pulmonary resection surgery|Uniportal video-assisted thoracoscopic surgery
15994206|NCT02933294|Procedure|Uniportal pulmonary resection surgery|Triportal video-assisted thoracoscopic surgery
15994207|NCT02933281|Biological|MTBVAC|Escalating dose levels (5 x 10^3 CFU, 5 x 10^4 CFU, 5 x 10^5 CFU, and 5 x 10^6 CFU
15994208|NCT02933281|Biological|BCG|BCG 5 x 10^5 CFU
15994209|NCT02933268|Dietary Supplement|High water intake|High water intake aimed at achieving an urine osmolality < 270mOsmo/kg. Individualised prescription for each participant based on the free water clearance formula calculation.
15994210|NCT02933268|Other|Ad libitum water intake|Water intake guided by thirst
15994211|NCT02933255|Biological|PROSTVAC-V/F|PROSTVAC-V (vaccinia) will be administered subcutaneously in an extremity (e.g., thigh) at a dose of 2x10^8 infectious units; PROSTVAC-F (fowlpox) will be administered subcutaneously in an extremity (e.g., thigh) at a dose of 1x10^9 infectious units.
15994212|NCT02933255|Drug|Nivolumab|Nivolumab is to be administered as a flat dose of 240 mg over approximately 60-minutes via IV infusion.
15994213|NCT02933242|Radiation|Stereotactic Ablative Body Radiotherapy|The total dose and number of fractions will depend on the site of disease. Treatment will be given daily, or every other day, over 1 -3 weeks
15994214|NCT02933229|Device|biopsy|patients enrolled in the study will receive gastroscopy and biopsies in order to evaluate status of pathology.
15994215|NCT02933229|Drug|H. pylori eradication|"H. pylori eradication therapy comprising esomeprazole, amoxicillin,clarithromycin and colloidal bismuth pectin.
~If failed in eradicating H. pylori, a culture based antimicrobial susceptibility test will be used to guide H. pylori eradication."
15994216|NCT02933190|Procedure|transvaginal surgery；UAE and D&C|For cesarean scar pregnancy treatment
15994217|NCT02933177|Behavioral|2 months control condition - 4 months chariot-flash|"The control condition is to propose the usual procedures for the management of productive symptoms during the emergence or increase of these symptoms.
~The chariot-flash condition is a chariot with eleven drawers. Each drawer contains an activity (lasting about 15 minutes):
~Boards of known photographs to recall autobiographical memories
~Newspapers to read, talk, associate memories around an article
~Massage Oil, refreshing wipes, cream to reconnect with the body
~Clay, cookie pieces, washable felt and paper to create shapes, draw.
~Walk with a person of the healthcare team the case of behavioral disorders in type of ambulation and untimely exit .
~Listening to music
~Relaxation-Breathing
~Cushion, foam balls to vent his energy on secure hardware.
~Plush doll or to invest a vector object of affection and empathy
~Sensory flash balls that the patient can squeeze, throw, roll.
~Games with which the patient can play according to its possibilities."
15994218|NCT02933177|Behavioral|4 months control condition-2 months chariot flash|"The control condition is to propose the usual procedures for the management of productive symptoms during the emergence or increase of these symptoms.
~The chariot-flash condition is a chariot with eleven drawers. Each drawer contains an activity (lasting about 15 minutes):
~Boards of known photographs to recall autobiographical memories
~Newspapers to read, talk, associate memories around an article
~Massage Oil, refreshing wipes, cream to reconnect with the body
~Clay, cookie pieces, washable felt and paper to create shapes, draw.
~Walk with a person of the healthcare team the case of behavioral disorders in type of ambulation and untimely exit .
~Listening to music
~Relaxation-Breathing
~Cushion, foam balls to vent his energy on secure hardware.
~Plush doll or to invest a vector object of affection and empathy
~Sensory flash balls that the patient can squeeze, throw, roll.
~Games with which the patient can play according to its possibilities."
15994219|NCT02933164|Device|Continuous Glucose Monitoring System|Effectiveness and safety of a Continuous Glucose Monitoring System
15994220|NCT02933151|Dietary Supplement|Nutritional Supplement|Selection of which supplement to give to the patients will be left to the dialysis unit's governing body as this study is not interested in a specific supplement's effect on nutrient restoration and subsequent outcomes but rather on oral replacement of amino acids regardless of the agent used.
15994261|NCT02932826|Drug|Insulin|Treated according to routine clinical practice at the discretion of the treating physician
15996073|NCT02919787|Drug|5-FU|Adjuvant treatment
15994221|NCT02933125|Behavioral|Group psychotherapy|"Motivational enhancement psychotherapy (MEP) for Youths:
~The participating youths have to attend one session a week for 10 weeks of a group program for relapse prevention based on motivational enhancement ideas and led by two experienced psychologists from the hospital.
~Parenting skill training (PST) for Caregivers:
~The PST program for the youths' caregivers also consist of 10 weekly, 120-minute sessions that were led by a senior consulting psychologist."
15994222|NCT02933125|Behavioral|Standard supervision|The standard supervision by the protection officers in Taiwan's Kaohsiung Juvenile and Family Court provide the adolescents with moral education, as well as counseling in their work or studies.
15994223|NCT02933112|Device|Auto-titrating mandibular positioner test|Participants will undergo a theragnostic test using the auto-titrating mandibular positioner to determine if they are eligible candidates to use oral appliance therapy for their obstructive sleep apnea. The device works by moving the lower jaw forward in response to respiratory events while the participant sleeps. All participants will undergo the same test.
15994224|NCT02933099|Drug|Aprepitant+palonosetron+dexamethasone|Patients will receive the chemotherapy drugs as well as the following antiemetic drugs: aprepitant (125 mg orally on day 1 and 80 mg orally on days 2 and 3) plus palonosetron 0.25 mg IV and dexamethasone (20 mg orally on day 1 and 8 mg orally on days 2 and 3)
15994225|NCT02933099|Drug|palonosetron+dexamethasone|Patients will receive the chemotherapy drugs as well as the following antiemetic drugs: palonosetron 0.25 mg IV and dexamethasone (12 mg orally on day 1 and 8 mg orally on days 2 and 3)
15994226|NCT02933086|Other|Specific exercises for lumbar stabilization|The Group 1 (G1) will perform therapy with specific exercises for lumbar stabilization whith the Swiss ball as a therapeutic resource, including warming; stretching of hamstrings, paraspinals, trapezes; phasic perineal exercise; tonic perineal exercise; pelvic lumbar synergism; trunk mobility; mobility of the shoulder girdle; balance; and slow pelvic balance.
15994227|NCT02933086|Other|Conventional therapy|The Group 2 (G2) will perform conventional therapy including stretching of lower limbs and trunk, with passive stretching of hamstrings; gluteus maximus; piriform; paraspinals; lumbar square; latissimus dorsi; scalene; trapezius.
15994228|NCT02933073|Biological|OncoImmunome|The OncoImmunome will be a substance composed of a mixture of seven to ten peptides each containing 17-18 amino acids. Given that the vaccine will be tumor-specific based upon mutant peptide sequences identified in each tumor transcriptome, the vaccine for each patient will likely be a unique composition.
15994229|NCT02933060|Other|Normal saline (1000 mL)|
15994230|NCT02933060|Other|Control|
15994231|NCT02933047|Procedure|Total laparoscopic hysterectomy|
15994232|NCT02933047|Procedure|Total laparoscopic hysterectomy|
15994233|NCT02933034|Drug|Manganese-enhanced MRI contrast reagent|MRI using manganese-enhanced MRI contrast reagent (manganese 0.28 mL/kg).
15994234|NCT02933034|Drug|Gadolinium-enhanced MRI contrast reagent|MRI using gadolinium-enhanced MRI contrast reagent (gadolinium 0.2 mmol/kg).
15994235|NCT02933021|Other|Blood sample taken|
15994236|NCT02933021|Other|Answering a lifestyle questionnaire|
15994237|NCT02933021|Other|Follow-up phone call from researcher (two years after first visit)|To enquire about status of participants monoclonal gammopathy of unknown significance, and whether there has been progression to multiple myeloma.
15994238|NCT02933008|Other|aNMT Biofeedback|"aNMT utilizes well-established visual feedback strategies to promote efficient, rapid and robust learning of complex movements. Athletes can discover how to move to create the desired feedback, even without explicit, conscious knowledge of how their movements relate to the visual pattern. aNMT biofeedback is created by calculating kinematic and kinetic data in real-time from the athlete's own movements. These values determine real-time transformations of the stimulus shape the athlete views via augmented-reality (AR) glasses during movement performance. The athlete's task is to move so as to create (animate) a particular stimulus shape that corresponds to desired values of the biomechanical parameters targeted by the intervention."
15994239|NCT02933008|Other|Sham Biofeedback|Sham biofeedback provides a similar phenomenological experience to aNMT biofeedback for athletes-both groups experience a shape that changes with their movements-but the sham biofeedback will not provide usable information to modify movement parameters during critical movement phases.
15994240|NCT02933008|Other|Neuromuscular Training|Participants will complete a 12-week, pre-season training program, over 6 weeks.
15994241|NCT02932969|Drug|BMS-986231|
15994242|NCT02932969|Drug|BMS-986231 Placebo|
15994243|NCT02932956|Genetic|GAP T cells|"Five different dosing schedules will be evaluated. Three to six patients will be evaluated on each dosing schedule. The following dose levels will be evaluated:
~DL1: 1x10^7/m2
~DL2: 3x10^7/m2
~DL3: 1x10^8/m2
~DL4: 3x10^8/m2
~DL5: 1x10^9/m2
~The doses are calculated according to the actual number of GPC3-CAR transduced T cells."
15994244|NCT02932956|Drug|Cytoxan|Cyclophosphamide will be given at a dose of 500 mg/m2/day for 3 days given intravenously.
15994245|NCT02932956|Drug|Fludara|Fludarabine will be given at a dose of 30 mg/m2/day for 3 days given intravenously.
15994246|NCT02932943|Drug|Rapastinel|Rapastinel pre-filled syringes for weekly IV injections.
15994247|NCT02932943|Drug|Placebo|Placebo-matching rapastinel pre-filled syringes for weekly IV injections.
15994248|NCT02932930|Procedure|QLB bloc|
15994249|NCT02932930|Drug|0.2% Ropivacaine|0,2ml/kg of 0,2% ropivacaine
15994250|NCT02932930|Drug|0.9% normal saline|0,2ml/kg of 0.9% normal saline
15994251|NCT02932917|Device|MapMySmoke|Each patient in the study arm will download and install the MapMySmoke app to record all of their smoking and craving events. The app will generate a quantitative summary of their smoking behavior during a pre-quit phase, and will provide dynamic text support messages during the post-quit phase. The app will also capture spatial details of any relapse events during the post-quit phase.
15994252|NCT02932904|Drug|Vortioxetine|Vortioxetine Overencapsulated Tablet
15994253|NCT02932904|Drug|Paroxetine|Paroxetine Overencapsulated Tablets.
15994254|NCT02932904|Drug|Placebo|Vortioxetine Placebo-matching Capsules.
15994255|NCT02932891|Drug|DSXS topical|topical treatment
15994256|NCT02932878|Drug|DSXS topical|topical treatment
15994257|NCT02932852|Procedure|Lipoaspiration|The patient will have a liposuction surgery from which the autologous ADAS cell to transplant in the cornea will be obtained.
15994295|NCT02932579|Drug|hydroxycontin/acetominophen|hydroxycontin 2.5 mg, acetominophen 325 mg
15994262|NCT02932813|Behavioral|THINK Program|Lessons and laboratory sessions will be 60 minutes, followed by physical activity sessions lasting 60 minutes. Laboratory activities include assessing heart rate, making healthy meals, learning portion sizes, brain challenges, and more. To improve physical activity participation, a wide selection of developmentally appropriate and multiculturally sensitive activities will be offered, such as sports, games, obstacle courses, and dance.
15994263|NCT02932800|Procedure|"Fixation with ballerina technique and flip"|
15994264|NCT02932800|Procedure|Habitual Fixation|Evaluation on the third and fift days, filogisticos and infectious signs, fixing loss, and culture
15994265|NCT02932800|Other|Evaluation on the third and fift days, filogisticos and infectious signs, fixing loss, and culture|
15994266|NCT02932787|Device|Height-adjustable workstation|
15994267|NCT02932774|Drug|Cetirizine|Cetirizine HCl 10 mg (1 mg/ml) syrup once daily before 10:00 AM for 2 weeks
15994268|NCT02932774|Drug|Loratadine|Loratadine HCl 10 mg (1 mg/ml) syrup once daily before 10:00 AM for 2 weeks
15994269|NCT02932774|Other|Placebo|Placebo syrup once daily before 10:00 AM for 2 weeks
15994270|NCT02932761|Drug|GnRHa|Two doses of GnRHa were administered by subcutaneous injection. The first dose was injected at the time of hysteroscopy examination, and the second dose was administered one day after the VR surgical procedure.
15994271|NCT02932761|Procedure|Vaginal repair of CSD|The procedure of vaginal repair of CSD was shown as following. The bladder was dissected away carefully from the uterus toward the abdominal cavity until the peritoneum was reached. The CSD tissue was cut to the normal healthy muscle after the abdominal cavity had been entered, and the lower uterine segments had been completely exposed. A double layer of 1-0 absorbable interrupted sutures was used to close the incisions.
15994272|NCT02932748|Dietary Supplement|Portion Controlled Meals (PCM)|Portion controlled meals provide conveniently packaged, low-energy, high-nutritional content food.
15994273|NCT02932748|Behavioral|Group Phone (GP)|Weight management program delivered via group conference call.
15994274|NCT02932748|Dietary Supplement|Conventional Diet|Conventional diet (CD) will consist of a nutritionally balanced, reduced energy, high volume, lower fat (fat= 20-30% energy) diet based on USDA's MyPlate recommendations.
15994275|NCT02932748|Behavioral|Individual Phone (IP)|Weight management program delivered via individual phone call.
15994276|NCT02932748|Behavioral|Enhanced Usual Care (EUC)|Weight management topics delivered face-to-face at clinic office every 6 months.
15994277|NCT02932722|Other|Control|Patients in the control groups do not receive any anesthetic during remote ischemic preconditioning.
15994278|NCT02932722|Drug|Propofol|Patients in the propofol group receive propofol anesthesia during remote ischemic preconditioning.
15994279|NCT02932722|Drug|Sevoflurane|Patients in the sevoflurane group receive sevoflurane anesthesia during remote ischemic preconditioning.
15994280|NCT02932709|Behavioral|suicide attempt|suicide attempt : We evaluated the effectiveness of telephone follow-up of patients who had referred to an emergency psychiatric unit for attempted suicide on any further attempt/s over the following year.
15994281|NCT02932696|Other|Cardiac training program|"This program takes place at the Cardiovascular Rehabilitation Department at the Nîmes University Hospital and includes a combination of various physical activities: treadmill, exercise bike, rower, aerobics, gymnastics, serious games, swimming. The program begins approximately within 3 months after myocardial infarction and consists of 20 consecutive days of training. The main physical activity is aerobic interval training (AIT).
~30-minute AIT sessions will occur 5x per week for 4 weeks.
~1 AIT session includes a warm up for 8 minutes to reach a heart rate during exercise corresponding to 20 to 30% of maximum aerobic power determined during the initial effort test. Then interval training occurs with 4x2 min of high intensity effort (heart rate during exercise corresponding to 80% of maximum aerobic power) alternating with 2 min of active recovery at 20-30% of maximum aerobic power. Then recovery for 8 minutes."
15994282|NCT02932683|Device|MedNav|MedNav is a tablet based platform that uses auditory and visual cues to prompt people to perform the correct steps in neonatal resuscitation.
15994283|NCT02932670|Other|costoclavicular nerve block|ultrasound-guided costoclavicular nerve block
15994284|NCT02932657|Other|Non interventional study|First individual interviews will be set up with teenagers of Nantes University Hospital . Then, focus group will be conduct with patients and professionals in Nantes and Foch University Hospital.
15994285|NCT02932644|Other|Baseline serum vitamin D level below 50 nmol/l|There is no medical intervention. The two groups are simple allocated depending on serum levels of D-total at the time of diagnosis
15994286|NCT02932644|Other|Baseline serum vitamin D level at or above 50 nmol/l|There is no medical intervention. The two groups are simple allocated depending on serum levels of D-total at the time of diagnosis
15994287|NCT02932631|Other|THERAPY CONTROL AND MOVEMENT OF INDUCTION|"Volunteers conventional physiotherapy group will stretching, strengthening and / or mobilization and functional training of the affected muscles with 3 sets of 10 repetitions for 60 minutes.
~The restriction therapy group and induction motion the volunteers will wear a brace on the top healthy member to be restricted in each session during the exercises for this group for a period of 60 minutes, encouraging tasks involving activities of daily living and / or daily. In group practice mental, the volunteers listen to a CD that in the first two minutes, will promote progressive relaxation where imaginary in a calm and quiet place followed by 13 minutes of listening to the restriction therapy exercise protocol and motion induction. The association group practices and mental restriction therapy, volunteer listens to the CD for 15 minutes following the same procedures mentioned in group practice mental, followed by exercises functional activities for 45 minutes in the paretic limb."
15994288|NCT02932618|Biological|von Willebrand factor (Recombinant)|Lyophilized powder and solvent to prepare solution for injection.
15994289|NCT02932618|Biological|Antihemophilic Factor (Recombinant)|Packaged in single boxes with 2 glass vials, with one vial containing the lyophilized ADVATE and the second vial containing the diluent.
15994290|NCT02932605|Drug|Placebo|Placebo
15994291|NCT02932605|Drug|Cannabidiol|Cannabidiol
15994292|NCT02932592|Device|Continuous Glucose Monitoring System (i Pro 2 - Medtronic)|This device can register blood glucose values and excursions. This device consists of a needle (applied in subcutaneous way) and of a recording device.
15994293|NCT02932579|Other|Pharmacogenomic Testing|Saliva collection (5mL)
15994294|NCT02932579|Drug|Ibuprofen|400 mg
15994296|NCT02932579|Drug|acetominophen|650 mg
15994297|NCT02932579|Drug|Oxycontin/acetominophen|5mg Oxycontin, 325 mg acetominophen. This will be a rescue medication is the other three pain medications do not work.
15994298|NCT02932566|Drug|Pirfenidone|Pirfenidone is an orally bioavailable, small molecule antifibrotic agent.
15994299|NCT02932566|Drug|Placebo|Placebo capsule, manufactured with the exact components of the Pirfenidone capsules, without the active ingredient / investigational medicinal product
15994300|NCT02932553|Device|BVS+OMT|bioresorbable vascular scaffold implantation plus optimal medical treatment
15994301|NCT02932540|Other|change of head position|patient can be allocated to the transient change of the head position, persistent lying flat position in the first 24 hours of the hospital admission and persistent sitting up in the first 24 hours of the hospital admission
15994302|NCT02932527|Behavioral|Questionnaire about cannabis consumption|Questionnaire about cannabis consumption will be assessed to infertile male exposed to cannabis and infertile male not exposed to cannabis.
15994303|NCT02932527|Procedure|blood intake|blood intake is done for infertile male exposed and infertile male not exposed.
15994304|NCT02932527|Procedure|Semen samples collection|Semen samples are collected for infertile male exposed and infertile male not exposed.
15994305|NCT02932514|Device|Eversense (Senseonics) Continuous Glucose Monitoring System|"Evaluate accuracy of Eversense CGM System to SMBG Meter.
~Compare performance between abdomen and arm insertion sites.
~Determine the usability of the Eversense System in a home-use setting for 180 days."
15994306|NCT02932501|Procedure|Conservative treatment|Disinfectant mouth rinses, Antibiotic therapy, Antifungal therapy
15994307|NCT02932501|Procedure|Surgical treatment|Superficial debridement, Complete removal of necrotic bone, Complete bone resection, When applicable revision and soft tissue coverage
15994308|NCT02932501|Procedure|Adjuvant non-surgical treatment|Hyperbaric oxygen therapy Pentoxifylline and tocopherol Ozone therapy Low level laser therapy Pain relief Anti-inflammatory treatment Platelet rich plasma Parathyroid hormone and teriparatide Bone morphogenetic protein
15994309|NCT02932488|Drug|Sumatriptan|Sumatriptan is a 5-HT1B receptor agonist used for treatment of migraine attacks
15994310|NCT02932475|Drug|Metformin|1000 mg twice a day
15994311|NCT02932475|Drug|Placebo|Delivered to match active drug
15994312|NCT02932462|Drug|DSXS|topical product
15994313|NCT02932462|Drug|Placebo|topical product
15994314|NCT02932436|Drug|Empagliflozin|10 mg per os daily for 12 weeks
15994315|NCT02932436|Drug|Placebo|amount of Placebo corresponding to empagliflozin 10 mg per os daily for 12 weeks
15994316|NCT02932423|Other|Control product E|Plain water
15994317|NCT02932423|Other|Test product A|Beverage with no sugar but sweetener
15994318|NCT02932423|Other|Test product B|Beverage with 22 g/L sugar and sweetener
15994319|NCT02932423|Other|Test product C|Beverage with 33 g/L sugar and sweetener
15994320|NCT02932423|Other|Test product D|Beverage with 47 g/L sugar and sweetener
15994321|NCT02932423|Other|Comparative product F|Beverage with 98 g/L sugar
15994324|NCT02932397|Drug|Intravenous dose of 0.5 mg/kg of propofol|
15994325|NCT02932397|Drug|Intravenous dose of 0.05 mL/kg of saline solution|
15994326|NCT02932384|Behavioral|Intervention-Passport and Peer Mentor|In addition to the passport and incentives described below for the control condition, participants assigned to the intervention will select a peer mentor trained in motivational interviewing. The mentor will help guide the participant to complete passport items and address priorities. Participants will also be incentivized for regular meetings with his peer mentor.
15994327|NCT02932384|Behavioral|Control-Passport Only|"A trained staff member will use a needs assessment and the participant's own priorities to develop a 'Passport to Wellness,' a personalized set of services whose access may encourage HIV prevention or address barriers to HIV testing.
~Example passport items include: getting an HIV test, attending an informational session about PEP/PrEP, meeting with a PrEP provider, attending 12-step meetings, yoga classes, a massage or Reiki session, or reviewing specific HIV prevention information online. Participants will be incentivized for each passport item they complete."
15994328|NCT02932371|Device|ECOM™.|
15994329|NCT02932371|Device|Trans-esophageal echography|
15994330|NCT02932358|Other|Flexible Family Visitation Model (FFVM)|Visitation to ICU patients allowed during the period of 12 consecutive hours per day.
15994331|NCT02932358|Other|Restrictive Family Visitation Model (RFVM)|Visitation to ICU patients allowed during intermittent periods according local ICU regulation.
15994332|NCT02932332|Other|High-flow Oxygen|Optiflow Respiratory Humidifier used to deliver HFOx. Oxygen flow will be maximized (set between 20 and 60 L/min), if tolerated, to minimize dyspnea. FiO2 will be set at 100%.
15994333|NCT02932332|Other|Low-flow Oxygen|Low-flow Oxygen will be delivered by Optiflow in an identical manner to high flow, except provided at 2 L/min using a nasal cannula identical to that used for high-flow devices.
15994334|NCT02932332|Other|High-flow Air|Two level air flow (high and low) will be delivered by Optiflow in an identical manner to oxygen air flows, except that researchers will use pressurized air instead of oxygen. LFOx and LFAir will be provided at 2 L/min using a nasal cannula identical to that used for high-flow devices.
15994335|NCT02932332|Other|Low-flow Air|Two level air flow (high and low) will be delivered by Optiflow in an identical manner to oxygen air flows, except that researchers will use pressurized air instead of oxygen. LFOx and LFAir will be provided at 2 L/min using a nasal cannula identical to that used for high-flow devices.
15994336|NCT02932319|Device|Foley catheter|The Foley cathter will be inserted at term + 4 days for 24 hours.
15994337|NCT02932319|Other|expectative|expectative until the next day befor starting the induction
15994338|NCT02932306|Drug|IDP-121 Lotion|IDP-121 lotion will be applied as per the instructions provided by the investigational center staff.
15994339|NCT02932306|Drug|IDP-121 Vehicle Lotion|IDP-121 vehicle lotion will be applied as per the instructions provided by the investigational center staff.
15994377|NCT02931942|Other|blood withdrawn|venous blood sampling
15995335|NCT02924909|Drug|carboplatin paclitaxel|induction carboplatin paclitaxel for 2 cycles
15994340|NCT02932293|Drug|SOF+DCV+SMV|Sofosbuvir (SOF) 400 mg tablet administered orally once daily; Daclatasvir (DCV) 60 mg tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily.
15994341|NCT02932280|Drug|Neratinib|Neratinib will be administered orally, or through existing gastrostomy feeding tube, once a day with food, preferably in the morning, continuously for 28-day cycles, with no rest between cycles. Dose will be scaled by body surface area (BSA).
15994342|NCT02932267|Drug|Adapalene 0.3% / BPO 2.5% gel|Epiduo Forte / Tactupump gel to be applied once a daily at bed time on entire face during 16 weeks
15994343|NCT02932254|Drug|Magnesium Sulfate|After 90% of baseline T4 / T1, are injected intravenously magnesium sulfate 60 mg/kg over 10 minutes (100 mL solution).
15994344|NCT02932254|Drug|Saline|After 90% of baseline T4 / T1, are injected intravenously saline solution over 10 minutes (100 mL solution).
15994345|NCT02932241|Behavioral|Computerized Dialectical Behavior Therapy Skills Training|8, 50 minute skill training sessions made available to participants each week
15994346|NCT02932228|Other|ImPACT|"The ImPACT team offers the following services:
~An intensive intake process, including a home visit if deemed appropriate
~Frequent contact (in-person, telephone, or secure messaging) tailored to a patient's needs
~After-hours access to on-call team member in order to avoid unnecessary emergency care
~Optimization of chronic condition management using evidence-based protocols
~Navigation of transitions between hospital and home
~Coordination of specialty care, including contact with specialists when indicated
~Rapid response to signs of health status deterioration or other stressful events
~Assess patient goals, advance directives, Physician Orders for Life-Sustaining Treatment"
15994347|NCT02932215|Drug|lorcaserin|Open label
15994348|NCT02932215|Other|Fitbit Charge HR|This is actually not an intervention- it is a tool to measure activity and sleep; all participants will be receiving one to collect data
15994349|NCT02932202|Other|Longitudinal Nutritional Counseling|
15994350|NCT02932202|Other|Standard Care|
15994351|NCT02932189|Device|Inspiratory muscle training|For the inspiratory muscle training, an isokinetic device (K5 Power Breath, United Kingdom) will be attached to the artificial airway.
15994352|NCT02932176|Device|Non-invasive vascular testing|Results of clinically indicated non-invasive vascular testing will be used to develop a machine learning algorithm
15994353|NCT02932176|Device|machine-learning algorithm|
15994356|NCT02932137|Drug|Interleukin-2|Patients receive low dose recombinant human Interleukin-2（HrIL-2）
15994357|NCT02932124|Device|mechanical chest compression device|
15994358|NCT02932111|Procedure|osteopathic session|3 osteopathic manipulative sessions. An six-week double-blind treatment period lasting from week 2 (Visit V1) until week 6, Visit 3.
15994359|NCT02932111|Procedure|Placebo manipulative session|3 osteopathic manipulative sessions. An six-week double-blind treatment period lasting from week 2 (Visit V1) until week 6, Visit 3.
15994360|NCT02932098|Behavioral|Discharge instructions reminders|"Week 1, Day 1: Click through each discharge instruction; Week 1, Days 2-7: Click through single list of all discharge instructions.
~Participants will receive a reminder of discharge instructions everyday for the first week post-discharge."
15994361|NCT02932098|Behavioral|Prompts to report symptoms via the web-enabled app|Group will receive reminders to enter new symptoms or changes in symptoms (based on a Likert scale or Y/N) on the following schedule: Week 1 (daily), Week 2 (every other day), Weeks 3-4 (once per week)
15994362|NCT02932098|Behavioral|Clinical Alerts|Alerts based on certain response thresholds are generated to inform the patient's care team of any concerning responses or trends that emerge from the patient reported outcomes. These alerts will inform providers of particular patient-related adverse events or symptoms requiring an intervention prior to the point that emergent medical care is needed. Information in the alert emails will include the participant's Medical Reference Number (MRN), initials, date of birth, and details about the symptom(s) that generated the alert. Pod nurses instructed to respond to any clinical alerts (sent via email) as soon as possible following standard of care.
15994363|NCT02932085|Device|Neurostar TMS Therapy System, NeuroStar XPLOR System|Repetitive transcranial magnetic stimulation
15994364|NCT02932059|Behavioral|Metamemory|Metamemory evaluation using a sentence construction strategy
15994365|NCT02932046|Dietary Supplement|Standardized noon meal|"The meal is treatment as usual in the specialized somatic stabilization ward for patients with severe anorexia nervosa."
15994366|NCT02932033|Procedure|Tack fixation of mesh|hernia mesh is fixed with synthetic glue (Histoacryl) (experimental) or spiral titanium tacks (active comparator) according to the result of randomization
15994367|NCT02932033|Procedure|Synthetic glue fixation|hernia mesh is fixed with synthetic glue (Histoacryl) (experimental) according to the result of randomization
15994368|NCT02932020|Drug|AlloGen-LI|interlaminar epidural injection of 2mL 0.5% marcaine and one 2-ml dose of AlloGen-LI
15994369|NCT02932020|Drug|depomedrol|interlaminar epidural injection of 2mL 0.5% marcaine and 1mL steroid (depomedrol 80mg/ml)
15994370|NCT02932020|Device|MRI|contrast enhanced MRI of the lumbar spine performed at Visit 1 and Visit 6 weeks (+7 days)
15994371|NCT02932020|Drug|0.5% marcaine|epidural injection of 2mL 0.5% marcaine
15994372|NCT02932007|Drug|Chloroquine Phosphate|Two tablets of study drug are to be taken on the day of study drug initiation and the next day, followed by one tablet each day for the next 12 days. Study drug to be orally administered and taken with food.
15994373|NCT02931994|Other|Knotted floss technique|The subjects use the knotted floss technique. In this modification of conventional flossing technique, a knot is tied in the floss at any distance in the middle third of the floss length. The floss is inserted past the interdental contact point by the conventional finger flossing technique in the non-knotted area and then during the 'to and fro movement' on the tooth surface cervical to contact point, the knotted area is engaged through the embrasure (Gomes et al 2016)
15994374|NCT02931981|Procedure|surgery or biopsy|Do radical surgery or biopsy to obtain a pathological result
15994375|NCT02931968|Device|Monolithic zirconia prosthesis|Edentulous arch subjects treated with a monolithic zirconia implant supported fixed dental prosthesis.
15994376|NCT02931955|Other|Blood draw, stool collection.|Blood will be drawn by certified personnel according to local regulations. Stool will be collected by the patients after instructions on how to use a stool collection kit.
15994378|NCT02931929|Drug|68Ga-NeoBOMB1, 2-vial kit|intravenous application of a radiopharmaceutical for Positron Emission tomography (PET)
15994379|NCT02931903|Other|Vita Enamic (hybrid dental ceramic)|Vita Enamic (hybrid dental ceramic) are provided as blocks to be milled using Computer aided design/Computer aided manufacturer (CAD/CAM) technology,
15994380|NCT02931903|Other|lithium disilicate glass-ceramic|All ceramic crowns (Lithium disilicate glass ceramic) milled by Computer aided design/Computer aided manufacturer (CAD/CAM) technology
15994381|NCT02931890|Drug|Docetaxel|3 weekly course of docetaxel i.v in arm 1 and 2
15994382|NCT02931890|Drug|Oxaliplatin|3 weekly course oxaliplatin as a 2 hr i.v. in arm 1 and 2
15994383|NCT02931890|Drug|Capecitabine|oral capecitabine in arm 1 and 2
15994384|NCT02931890|Procedure|gastrectomy|resection of gastric cancer after pre-operative chemotherapy for all arms
15994385|NCT02931890|Radiation|radiotherapy of gastric cancer|5 weeks of radiation, 5 times a week with a total of 45 Gy (in arm 2 and 3)
15994386|NCT02931890|Drug|Paclitaxel|5 weeks of paclitaxel i.v once a week (in arm 2 and 3)
15994387|NCT02931890|Drug|Carboplatin|5 weeks of carboplatin i.v once a week (in arm 2 and 3)
15994388|NCT02931877|Drug|sevoflurane|
15994389|NCT02931877|Drug|propofol|
15994390|NCT02931864|Other|Online mindfulness training|5 weekly sessions of online self-administered mindfulness training programme in which they will receive audio-recorded and video-recorded instructions, pictorial or text-based instructions for various mindfulness exercises such as body scan meditation, mindful breathing and walking meditation.
15994391|NCT02931864|Other|Online symptom management|5 weekly online education module in which they will receive video-recorded, audio-recorded, pictorial or text-based instructions for various self-management strategies. Topics include fatigue, pain, numbness/tingling, lymphedema, anxiety/depression, and problems with sleeping.
15994392|NCT02931851|Other|ICU Families Website|Professionally developed website for relatives of ICU patients
15994393|NCT02931851|Other|Placebo|Standard Information provided online
15994394|NCT02931838|Drug|BMS-986165|
15994395|NCT02931838|Drug|Placebo for BMS-986165|
15994396|NCT02931825|Behavioral|Reminder letter|"The letter will consist in several parts:
~Reminder of : -the need of individual follow-up for high risk people for colorectal cancer AND - the general recommendations (one colonoscopy every 5 years)
~Recommendation to consult their general practitioner or gastroenterologist if they haven't done their follow up
~Request information if they've done their follow-up or if we have incorrect information
~Indication that the letter is sent as part of a surveillance program specific for high risk people for colorectal Cancer"
15994397|NCT02931799|Behavioral|Nurse Follow-Up|Organized follow-up with an IBD advanced practice nurse at 24-48 hours, 7 days, and 30 days post-discharge; to monitor patients' health status with respect to their IBD.
15994398|NCT02931799|Other|Electronic Monitoring|"Patients will be provided access to a web-based application entitled: 'Health Promise'. The application will generate surveys every 3 days, where patients will self-report their IBD symptoms, quality of life and medication adherence on three separate scales:
~PRO-2 Scale for patients with Crohn's Disease
~6-Point Mayo Score for patients with Ulcerative Colitis
~Morisky Medication Adherence Scale (MMAS-4)
~The survey responses will be monitored by an IBD advanced practice nurse, to triage patients for outpatient follow-up."
15994399|NCT02931799|Other|Post-Discharge Questionnaire|Patients will complete a web-based questionnaire at 30 days post-discharge. The questionnaire will capture information related to: Demographics, Patient Satisfaction as measured by the CACHE questionnaire; IBD related quality of life as measured by the IBDQ questionnaire; Disease activity as measured by PRO-2 scale for Crohn's Disease or 6-Point Mayo Score for Ulcerative Colitis; and Patient Satisfaction with the 'Health Promise' application.
15994400|NCT02931799|Other|Post-Discharge Questionnaire|Patients will complete a web-based questionnaire at 30 days post-discharge. The questionnaire will capture information related to: Demographics, Patient Satisfaction as measured by the CACHE questionnaire; IBD related quality of life as measured by the IBDQ questionnaire; Disease activity as measured by PRO-2 scale for Crohn's Disease or 6-Point Mayo Score for Ulcerative Colitis.
15994401|NCT02931799|Other|Standard of Care|Discharge summary detailing inpatient IBD admission; in addition to outpatient follow-up with a Gastroenterologist post-discharge
15994402|NCT02931786|Drug|propofol|propofol, midazolam and atropine administration via intravenous cannula.
15994403|NCT02931786|Drug|Ketamine propofol mixture|Administration of ketamine propofol mixture, midazolam and atropine via intravenous cannula
15994404|NCT02931773|Device|Task Force® Monitor|A head up tilt test carried out with a Task Force monitoring system
15994405|NCT02931760|Device|subcutaneous pacemaker|During implant of a pacemaker the device is either implanted subcutaneously or intramuscular
15994406|NCT02931760|Device|intramuscular pacemaker|During implant of a pacemaker the device is either implanted subcutaneously or intramuscular
15994407|NCT02931747|Dietary Supplement|Placebo|Subjects are received Placebo once daily for 16 weeks.
15994408|NCT02931747|Dietary Supplement|Bacopa Monnieri 300 mg/day|Subjects are received Bacopa Monnieri at the dose of 300 mg/day once daily for 16 weeks.
15994409|NCT02931747|Dietary Supplement|Bacopa Monnieri 600 mg/day|Subjects are received Bacopa Monnieri at the dose of 600 mg/day once daily for 16 weeks.
15994410|NCT02931734|Drug|Resin modified glass ionomer|Prophylaxis, washing and removing water excess , apply the Clinpro forming a uniform layer of 0.5mm, lightcure for 20 seconds
15994411|NCT02931734|Drug|Potassium Nitrate 2%|Prophylaxis, apply uniformly on the teeth, wait 10 minutes, remove the gel from the teeth with cotton and abundant water.
15994412|NCT02931734|Procedure|Low level laser therapy|Prophylaxis, applying infrared laser at low power in points: mesial, buccal, distal and in the apical point in the foyer of fornix with power of 110MW for 11 seconds at each point.
15994413|NCT02931721|Diagnostic Test|MRI|Pelvis MRI
15994414|NCT02931708|Other|Diaphragm functional electrical stimulation|Functional electrical stimulation: 80 Hz frequency, 0.4 ms pulse, rise 1s, 1s time on, decay 2s, 1s time off, intensity as patient tolerance
15994415|NCT02931695|Other|evaluation of QT interval duration|ECG to evaluation of QT interval duration
15994416|NCT02931695|Other|circulating sex hormones levels sample|Association between circulating sex hormones levels (progesterone, estradiol, testosterone, FSH) and QTcF duration (univariate and multivariate analysis).
15994417|NCT02931669|Other|Qualitative Descriptive Study|
15994418|NCT02931656|Other|Aquatic exercise|The aquatic exercise program will be under the professional guidance of a physiotherapist, with water at a temperature of around 26 to 28°C. The exercise sessions will be executed following the steps: 1) Heating (stretching and flexibility, static method, during 5'); 2) Aerobic exercise (running, displacements and combined movements of arms and legs, with 1minute interval, to 1minute activity and of during 20') 3) Spot exercises (strength / endurance of the upper and lower limbs and abdomen, using the resistance of water for 15') 4) Relaxation (slow walks for 5'). During the sessions of exercises the pregnant women will have heart rate monitored by the frequency meter (Polar Electro OY) to control the intensity of the exercises that will focus on the range of moderate intensity.
15994419|NCT02931643|Other|High fat challenge breakfast|In this intervention, subjects are asked to consume high fat breakfast without mixed-spices. Standardized high fat breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 20:60:20
15994420|NCT02931643|Other|High fat challenge breakfast with mixed-spices|In this intervention, subjects are asked to consume high fat breakfast with mixed-spices. Standardized high fat breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 20:60:20
15994421|NCT02931630|Other|Whey protein powder|60 g of whey protein powder
15994422|NCT02931630|Other|Maltodextrin powder|60 g of Maltodextrin powder
15994423|NCT02931630|Other|High fiber bread|Wheat bread with high content of dietary fibers (approximately 30 g fibers/day)
15994424|NCT02931630|Other|Low fiber bread|Wheat bread with low content of dietary fibers (approximately 10 g fibers/day)
15994425|NCT02931617|Other|Chest Physiotherapy|
15994426|NCT02931617|Device|Post-therapy lung volume measurements|In both intervention groups.
15994427|NCT02931604|Device|SinuSafe Medical Device for Maxillary Sinus|Sinus lavage via the natural sinus ostium, without ostial dilation.
15994428|NCT02931591|Drug|Metformin|Metformin is administered as an oral solution
15994429|NCT02931591|Drug|Growth Hormone|Growth Hormone- no specific band
15994430|NCT02931591|Drug|Placebo|
15994431|NCT02931578|Other|Glucose100|
15994432|NCT02931578|Other|Glucose50|
15994433|NCT02931578|Other|Glucose42|
15994434|NCT02931578|Other|Oral Glucose Tolerance Test|For each OGTT, subjects will consume 50g of sweetener dissolved in water at a comfortable pace within 10 minutes. Blood samples for plasma glucose and insulin will be taken at -20, 0, 15, 30, 45, 60, 90 and 120 min after consuming the glucose drink. Plasma fructose will be tested at baseline, 30, 60, 90 and 120 minutes.
15994435|NCT02931565|Drug|Olinciguat|oral tablet
15994436|NCT02931565|Drug|Matching Placebo|oral tablet
15994437|NCT02931552|Behavioral|Nuevo Amancer-II Stress Management Program|Participant meets weekly with a trained interventionist called a Compañera (a peer who has had breast cancer) to complete a structured 10-week program designed to develop cognitive and behavioral skills to manage stress and distress, improve communication with family and clinicians, and increase knowledge of self-management after breast cancer.
15994438|NCT02931539|Drug|Maribavir|Maribavir 400 milligrams (mg) (2x200 mg tablets) will be administered twice daily for 8 weeks.
15994439|NCT02931539|Drug|Ganciclovir|Ganciclovir as per the investigator's prescribed dosing regimen will be administered for 8 weeks.
15994440|NCT02931539|Drug|Valganciclovir|Valganciclovir as per the investigator's prescribed dosing regimen will be administered for 8 weeks.
15994441|NCT02931539|Drug|Foscarnet|Foscarnet as per the investigator's prescribed dosing regimen will be administered for 8 weeks.
15994442|NCT02931539|Drug|Cidofovir|Cidofovir as per the investigator's prescribed dosing regimen will be administered for 8 weeks.
15994443|NCT02931526|Drug|Tigecycline|Patients who have the definitive diagnosis to treat with tigecycline for bacterial infection will be started on tigecycline with a loading dose 200mg IV followed by 100mg IV every 12h.
15994444|NCT02931513|Other|Blood samples|
15994445|NCT02931513|Device|Fibroscan|
15994446|NCT02931513|Other|Questionnaires|
15994447|NCT02931513|Biological|Liver biopsy|Liver biopsy will only be obtained if obtained as part of the diagnosis (will not be obtained for study purpose only)
15994448|NCT02931487|Behavioral|Attentional Bias Modification|Computerized
15994449|NCT02931487|Behavioral|Sham Comparator|Computerized
15994450|NCT02931474|Drug|Tesamorelin|Growth Hormone-Releasing
15994451|NCT02931474|Other|Placebo|
15994452|NCT02931461|Procedure|Endobronchial Ultrasound-Guided Transbronchial Needle Aspiration|
15994453|NCT02931448|Device|Dosage of the blood HbCO thanks to the carboxymeter MASIMO RAD 57|
15994454|NCT02931435|Procedure|Nerve Block with Radiofrequency Ablation|Ablation of the genicular nerves of the knee by radiofrequency
15994455|NCT02931435|Procedure|Nerve Block with Sham Radiofrequency Ablation|Genicular radiofrequency of the knee without neurotomy
15994456|NCT02931422|Behavioral|Financial incentive|Conditional cash transfer upon HIV testing
15994457|NCT02931409|Procedure|Optimal PEEP|Optimal PEEP determined by Cstat during PEEP titration procedure.
15994458|NCT02931409|Procedure|Standard PEEP|Lung protective mechanical ventilation applying a PEEP value of 6 cmH2O
15994459|NCT02931396|Device|FES|
15994460|NCT02931383|Drug|Liraglutide 3 mg (Saxenda)|
15994461|NCT02931383|Drug|Liraglutide 3 mg placebo|
15994462|NCT02931370|Dietary Supplement|Dietary Supplement: Intensive dietary intervention|Participants receive a hypo-caloric formula diet containing 800 to 1,000 kcal/day. The formula diet consists of ready-to-use meal bars and powders to mix with water to make shakes, soups, or porridge. The weight loss programme consists of an 8-week period with full meal replacement by a standard liquid energy intake protocol. To facilitate compliance with the programme, participants will be scheduled for weekly facility-based group sessions with 6-8 participants led by a dietician. The recommendations for daily nutrient intake will be met.
15994463|NCT02931357|Device|Hyaluronic Acid 0.54%|Administration: application of the gel on the gingival tissue, massage it in gently, five to six times a day
15994464|NCT02931357|Drug|Calgel®|Administration: application of the gel on the gingival tissue, massage it in gently, three/four times a day (away from meals). In any case the interval between gel applications must be at least 3 hours.
15994545|NCT02930668|Dietary Supplement|Glucosanol 350mg|
15994546|NCT02930668|Dietary Supplement|Glucosanol 500mg|
15994547|NCT02930668|Dietary Supplement|Placebo|
15994465|NCT02931344|Dietary Supplement|Dietary Supplement: Dietary Supplement: Intensive dietary intervention|Participants receive a hypo-caloric formula diet containing 800 to 1,000 kcal/day. The formula diet consists of ready-to-use meal bars and powders to mix with water to make shakes, soups, or porridge. The weight loss programme consists of an 8-week period with full meal replacement by a standard liquid energy intake protocol. To facilitate compliance with the programme, participants will be scheduled for weekly facility-based group sessions with 6-8 participants led by a dietician. The recommendations for daily nutrient intake will be met.
15994466|NCT02931318|Behavioral|Nevsehir|The data of the study were collected with the questionnaire
15994467|NCT02931305|Drug|Epimedium Prenylflavonoids Extract|Each Epimedium Prenylflavonoids Extract capsule contains 370 mg of EPIMEDIUM EXTRACT
15994468|NCT02931305|Drug|Placebo|Use iron oxide (brown, black and yellow) to mimic Epimedium Prenylflavonoids Extract.
15994469|NCT02931292|Procedure|Laparoscopic sleeve gastrectomy|"Special care was given to the complete mobilization of the gastric fundus, with meticulous dissection of the posterior gastric wall from the left pillar. A 36-Fr calibration bougie was used. Resection started 2 to 6 cm from pylorus, and it was conducted upward to 1.5 cm from the angle of His, to avoid the critical area. A gastric remnant of 60-80 mL volume (measured by administering methylene blue saline solution via nasogastric tube) was obtained."
15994470|NCT02931279|Device|PASS OCT® Spinal System|Posterior osteosynthesis of the cervical and upper thoracic spine
15994471|NCT02931266|Device|PASS MIS®|Posterior mini-invasive osteosynthesis
15994472|NCT02931253|Drug|Metformin|Metformin will be started as one pill (500 mg metformin) once a day with a meal. If the subject has no side effects from this dose, the dose will be increased to two pills (1000 mg) twice a day to be taken with meals.
15994473|NCT02931240|Device|Revivent TC|Treatment of LV scar
15994474|NCT02931227|Procedure|temperature obtained by the non-invasive method of zero-heat flux|
15994475|NCT02931227|Procedure|esophageal temperature|
15994476|NCT02931227|Procedure|intracerebral temperature|
15994477|NCT02931227|Procedure|arterial temperature|
15994478|NCT02931214|Drug|GMI-1359|
15994479|NCT02931214|Drug|Placebo|
15994480|NCT02931201|Device|18F-FDG PET/CT|18F-FDG PET/CT will be conducted before, during and after chemotherapy. Patients were instructed to fast for at least 6 h before PET. The blood glucose level was measured to ensure that it was <200 mg/dL. 18F-FDG was intravenously administered at a dose of 3.7 MBq/kg. Approximately 60 ± 10 min post-injection, a whole-body acquisition commenced in 6-8 bed positions (1 min/bed) using a hybrid system (PHILIPS Gemini TF) and covered from the base of the skull to the upper thigh, which was followed by CT in a non-contrast phase (modulated 100 mAs; 120 kV; slice thickness, 3 mm) for attenuation correction and anatomical localization purposes. The head acquisition was performed in one bed position (8-10 min/bed).
15994481|NCT02931188|Drug|Anacetrapib|No drug administration will occur on this sub-study. Participants will receive treatment on the main trial HPS3/TIMI 55: REVEAL (NCT01252953)
15994482|NCT02931188|Drug|Statin|No drug administration will occur on this sub-study. Participants will receive treatment on the main trial HPS3/TIMI 55: REVEAL (NCT01252953)
15994483|NCT02931188|Drug|Placebo|No drug administration will occur on this sub-study. Participants will receive treatment on the main trial HPS3/TIMI 55: REVEAL (NCT01252953)
15994484|NCT02931175|Drug|ACTH gel|Starting at month 6, retreatment will be offered to study subjects who have demonstrated any level of response during the first 6 months and who meet any of these Retreatment Criteria listed below. Patients receiving retreatment will receive the dose that was assigned to them at randomization.
15994485|NCT02931162|Other|Herb-partitioned moxibustion|Patients receive herb-partition moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks.
15994486|NCT02931162|Other|Sham herb-partitioned moxibustion|Patients receive sham herb-partition moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks.
15994487|NCT02931149|Drug|Platelet-rich plasma|Submucosal injection with PRP was performed prior to endoscopic resection
15994488|NCT02931136|Drug|Huperzine A|The participants will treatment by the Huperzine A 200 ug/day in 52 weeks.
15994489|NCT02931136|Drug|Placebo|The participants will treatment by the placebo in 52 weeks.
15994490|NCT02931123|Drug|lattulose and rifaximine|
15994491|NCT02931110|Drug|CBL0137|CBL0137 administered IV weekly on Days 1 and 8 of repeated 21 day treatment cycles. Number of Cycles: 2 or until progression or unacceptable toxicity develops
15994492|NCT02931097|Device|Deep brain stimulation|Stimulating deep brain electrodes and pulse generator
15994493|NCT02931097|Device|Sham stimulation|
15994494|NCT02931084|Other|Rehabilitation|In line with current treatment guidelines, patients will undergo rehabilitation for at least the first three months, before a decision regarding ACL reconstruction is taken
15994495|NCT02931084|Procedure|ACL reconstruction|Approximately half of the patients will have ACL-reconstruction after an initial time of rehabilitation
15994496|NCT02931071|Drug|filgrastim|G-CSF (12 μg/Kg/12 h) 8 days.
15994497|NCT02931071|Drug|plerixafor|Plerixafor 0,24 mg/kg/day after the fourth day of G-CSF, and until 5 cells CD34+/μL, max 4 doses of plerixafor
15994498|NCT02931058|Other|Two knee-extension exercise sessions per week.|"Each exercise session comprises a single strength training exercise; knee-extension, which is performed in 3 sets with 12 RM repetitions in each set.
~The knee-extension resistance training exercise is performed with an elastic exercise band."
15994499|NCT02931058|Other|Four knee-extension exercise sessions per week.|"Each exercise session comprises a single strength training exercise; knee-extension, which is performed in 3 sets with 12 RM repetitions in each set.
~The knee-extension resistance training exercise is performed with an elastic exercise band."
15994500|NCT02931058|Other|Six knee-extension exercise sessions per week.|"Each exercise session comprises a single strength training exercise; knee-extension, which is performed in 3 sets with 12 RM repetitions in each set.
~The knee-extension resistance training exercise is performed with an elastic exercise band."
15994501|NCT02931045|Drug|Ticagrelor|Comparison of ticagrelor with another antiplatelet drug (clopidogrel)
15994502|NCT02931045|Drug|Clopidogrel|Comparison of clopidogrel with another antiplatelet drug (ticagrelor)
15994548|NCT02930655|Drug|Lucerastat|Hard gelatin capsules for oral administration formulated at a strength of 250 mg, and administered as 4 capsules in the morning and 4 capsules in the evening.
15994503|NCT02931032|Procedure|Sampling of dental plaque / infected dentine|A sample of dental plaque / infected dentine will be taken during routine dental treatment and cultivated in a lab. The headspace above the culture will be sampled and analyzed in GC-MS for the detection of unique volatile organic compounds emitted by the plaque components.
15994504|NCT02931019|Procedure|Intubation|
15994505|NCT02931006|Other|water|
15994506|NCT02931006|Other|bovine milk|
15994507|NCT02930993|Biological|anti-mesothelin CAR T cells|Patients will be received a three-day regimen of chemotherapy consisting of cyclophosphamide aimed to deplete the lymphocytes. 1 to 4 days after lymphodepletion, patients are intravenously infused with anti-mesothelin CAR T cells in a three-day split-dose regimen (day0,10%; day1, 30%; day2, 60%).
15994508|NCT02930980|Device|Investigational Software loaded on Micra device|Subject will receive an investigational software loaded on subject's Micra device
15994509|NCT02930967|Biological|autologous CSR T|Patients will be received a three-day regimen of chemotherapy consisting of cyclophosphamide aimed to deplete the lymphocytes. 1 to 4 days after lymphodepletion, a prescribed dose of CSR T cells will be intravenously infused to patient in a three-day split-dose regimen (day0,10%; day1, 30%; day2, 60%).
15994510|NCT02930954|Drug|Gefitinib|Patients received Gefitinib 250mg Qd orally until disease progression, intolerable toxicity or death.
15994511|NCT02930954|Drug|pemetrexed or gemcitabine plus carboplatin,|doublet chemotherapy with pemetrexed or gemcitabine plus carboplatin per 3 weeks
15994512|NCT02930954|Drug|bevacizumab|bevacizumab 7.5mg/kg intravenously per 3 weeks
15994513|NCT02930941|Drug|Tranexamic Acid|TXA (100 mg/1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
15994514|NCT02930941|Drug|0.9% Sodium Chloride|0.9% Sodium Chloride (1mL) in to the affected nostril(s) via intranasal atomization device. May repeat 2 doses in each affected nostril(s).
15994515|NCT02930928|Other|Accuracy of weight estimation|Computer based comparison
15994516|NCT02930915|Device|Hand-held laser scanner|The laser scanning is non-intrusive and the scan can be completed in approximately 15 minutes. The scanning process involves the patient sitting in a chair while a researcher performs the scan. As a precautionary measure we require the patient to wear an eye mask as although the scanner is CE marked and completely safe . The process can be completed in stages (e.g. 3 x 5 minutes) with a break of 2-3 minutes between each session. The laser scanner will then be moved around the patient to obtain a set of 3D points forming the surface of the patient's head. We believe the laser scanning to be the most accurate way to acquire the surface of the patient's face / head and we wish to compare the models we obtain with surfaces rendered from the patient's CT data set.
15994517|NCT02930902|Drug|Gemcitabine Hydrochloride|Given IV
15994518|NCT02930902|Other|Laboratory Biomarker Analysis|Correlative studies
15994519|NCT02930902|Drug|Nab-paclitaxel|Given IV
15994520|NCT02930902|Drug|Paricalcitol|Given IV
15994521|NCT02930902|Biological|Pembrolizumab|Given IV
15994522|NCT02930902|Procedure|Therapeutic Conventional Surgery|Undergo surgical resection of tumor
15994523|NCT02930889|Device|Prostate Artery Embolization|Prostate Artery Embolization
15994524|NCT02930876|Behavioral|Resistance training|Set of muscle strengthening exercises of all major muscle groups, guided by physiotherapists.
15994525|NCT02930863|Other|pulse oximetry software|This pulse oximetry software will utilize automated verbal prompts that direct the patients to breathe when their pulse oximetry reading falls at or below 93%.
15994526|NCT02930863|Behavioral|Brief post-PACU stay survey.|Complete a brief post-PACU stay survey focused around their satisfaction and experience during their time in the PACU.
15994527|NCT02930850|Device|Rad-67 Pulse oximeter|Noninvasive pulse oximeter that measures hemoglobin
15994528|NCT02930837|Drug|alteplase|
15994529|NCT02930824|Genetic|CYP2C19 genotyping|All proton pump inhibitors are metabolized in part by the CYP2C19 enzyme, which is encoded by the highly polymorphic CYP2C19 gene. Based on variations within this gene the effectiveness of the drug may be reduced.
15994530|NCT02930811|Drug|Sildenafil 100 mg oral morning dose|"Measurement of maximal walking distance on a constant load treadmill test, SF-36 questionnaire, and Edimburg questionnaire at inclusion, 1 month, 3 month and 6 month.
~Events occurence questionnaires, Tolerance and adverse events questionnaire, Welch questionnaire and walk recommendation at inclusion, 7 days, 14 days, 1-2-3-4-5-6 and 9 months"
15994531|NCT02930811|Drug|Placebo oral morning dose|"Measurement of maximal walking distance on a constant load treadmill test, SF-36 questionnaire, and Edimburg questionnaire at inclusion, 1 month, 3 month and 6 month.
~Events occurence questionnaires, Tolerance and adverse events questionnaire, Welch questionnaire and walk recommendation at inclusion, 7 days, 14 days, 1-2-3-4-5-6 and 9 months"
15994532|NCT02930798|Drug|BAY987516|"Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
~(Formulation Code:Z46-116)"
15994533|NCT02930785|Drug|BAY987517|"Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
~(Formulation Code:Z46-104)"
15994534|NCT02930772|Drug|BAY987516|"Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
~(Formulation Code: Z46-100)"
15994535|NCT02930759|Drug|BAY987516|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z46-096)
15994536|NCT02930746|Drug|BAY987516|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z46-092)
15994537|NCT02930733|Drug|Bupivacaine|30 ml %0,25 bupivacaine bilaterally
15994538|NCT02930733|Drug|Saline|2 ml saline subcutaneously bilaterally
15994539|NCT02930707|Drug|Magnesium Sulfate|ultrasound guided TAP block with 20 mL of 0.25% bupivacaine plus 2 mL magnesium sulfate 10% (200 mg), on each side of the abdominal wall.
15994540|NCT02930707|Drug|Bupivacaine|ultrasound guided TAP block with 20 mL of 0.25% bupivacaine on each side of the abdominal wall.
15994541|NCT02930694|Drug|JNJ-54175446 (capsule)|Participants will receive JNJ-54175446 capsule at a dose of 50 mg or 100 mg, orally.
15994542|NCT02930694|Drug|JNJ-54175446 (suspension)|Participants will receive JNJ-54175446 suspension at a dose of 50 mg or 100 mg, orally.
15994543|NCT02930681|Dietary Supplement|Glucosanol 500mg|
15994544|NCT02930681|Dietary Supplement|Placebo|
15994549|NCT02930655|Drug|Enzyme replacement therapy (ERT)|All the subjects received an ERT as background therapy for at least 24 months prior to the screening visit and they had to continue receiving this treatment during the conduct of the study.
15994550|NCT02930642|Behavioral|Mindful Eating|Mindful eating is a behavioral strategy in which food is eaten slowly, with deliberate and focused attention on the features of food, the process of eating, and physiological responses to eating. Objectivity is key.
15994551|NCT02930642|Other|Nutrition DVD|Participants watch a 50 minute video on nutrition to control for verbal aspects of food.
15994552|NCT02930629|Device|Train-of-Four (TOF) Watch|"For patients, on arriving in PACU after having had muscle relaxants during general anaesthesia
~Two ECG electrodes will be placed 4 cm apart over the path of the ulnar nerve of the wrist after cleaning the skin with alcohol swabs.
~The TOF force transducer will be placed on the volar aspect of the thumb.
~The TOF Watch leads will be attached to the ECG electrodes.
~A TOF stimulus will be applied: four twitches at 2Hz (every 0.5 seconds), each twitch lasting 0.2ms, and at a current of 50 mA. As far as possible, this will be done when patients are still slightly drowsy from the effects of anaesthesia.
~Two TOF ratio will be elicited (two sets of four twitches 15 seconds apart), and an average of the two taken"
15994553|NCT02930616|Device|Patients in Group 1 will receive pCLE at first and WLE 2 months later|
15994554|NCT02930616|Device|patients in Group 2 will receive WLE at first and pCLE 2 months later.|
15994555|NCT02930590|Other|Alternating low pressure mattress with air loss function|IsoAir, Stryker, USA
15994556|NCT02930590|Other|Gel mattress|IsoGel, Stryker, USA
15994557|NCT02930590|Other|Basic foam|Standard hospital mattress
15994558|NCT02930564|Other|CDED + milk fat and gluten|CDED phase 1- induction phase a milk fat /emulsifier challenge (one scoop of ice cream and one slice of yellow processed cheese every day in the evening over 7 days), or a gluten/emulsifier challenge ( 3-4 slices of bread)
15994559|NCT02930551|Drug|Lidocaine|
15994560|NCT02930551|Drug|Isotonic Saline|
15994561|NCT02930538|Other|Survey|Completing a survey on RedCap
15994562|NCT02930525|Other|High Flow nasal cannula|Application of humidified heated ambient air with flow rates adapted to body weight of respective subject. Incremental increase of fraction of inspired oxygen as appropriate to maintain oxygenation (defined as transcutaneous pulse oximetry above 93%).
15994563|NCT02930525|Other|Standard respiratory care|Standard respiratory care. Oxygen delivered via low flow nasal cannula, increase of fractions of inspired oxygen to maintain desired oxygenation as defined per protocol.
15994564|NCT02930512|Procedure|DXA scan|
15994565|NCT02930512|Procedure|pQCT scan|
15994566|NCT02930499|Device|Hyalomatrix extra-cellular matrix|An exta-cellular matrix made from hyaluronic acid
15994567|NCT02930499|Device|Mepilex wound dressing|A siliconized non-adhesive foam wound dressing
15994568|NCT02930486|Device|ZipTight suture endobutton|Zimmer Biomet ZipTight suture endobutton
15994569|NCT02930486|Device|Tricortical 3.5 mm syndesmotic screw|Depuy Synthes 3.5 mm screw
15994570|NCT02930473|Behavioral|NIC Psychotherapeutic Intervention(s) for Anxiety|Patients will be treated by NIC psychotherapeutic intervention(s) for anxiety (e.g. anxiety reduction) plus psychopharmaceuticals prescribed by their psychiatrist.
15994571|NCT02930473|Drug|Psychopharmaceuticals (any drugs prescribed by the psychiatrist)|Patients will be treated only by psychopharmaceuticals prescribed by their psychiatrist.
15994572|NCT02930447|Device|Autologous glue|Patients will undergo abdominoplasty according to the procedure routinely used in the Department of Plastic, Reconstructive and Aesthetic Surgery of HUG. At the end of the procedure, patients assigned to the experimental group will be additionally treated with an application of autologous glue prepared with RegenKit®-Surgery in the undermining region space between fascia and skin, just before closure of the surgical wound.
15994573|NCT02930434|Dietary Supplement|cholecalciferol|Administration of vitamin D3
15994574|NCT02930421|Other|Exercise training|30 min of exercise on a cycle ergometer at 80% of HRmax, 30 min of strength training of upper and lower limbs
15994575|NCT02930408|Procedure|electrocardiogram|
15994576|NCT02930408|Procedure|Echocardiography|
15994577|NCT02930395|Procedure|serum S100B assay|
15994578|NCT02930382|Other|Baroreflex assessment|
15994579|NCT02930369|Procedure|ILM peeling surgery|4PD or 2PD diameter of ILM peeling in surgery was given to patients with idiopathic macular hole (IMH)
15994580|NCT02930356|Other|NSPT|NSPT was done by ultrasonic scalers after administration of pre procedural mouth rinse in the test group (20 smokers with chronic periodontitis).Clinical parameters (GI,PI) were assessed at baseline and at the end of 3 months.2 ml blood was drawn to assess the plasma hepatocyte growth factor levels at baseline and at the end of 3 months.
15994581|NCT02930356|Other|Scaling and root planing|Scaling and root planing was done by ultrasonic scalers after administration of pre procedural mouth rinse in the control group (20 non smokers with chronic periodontitis).Clinical parameters (GI,PI) were assessed at baseline and at the end of 3 months.2 ml blood was drawn to assess the plasma hepatocyte growth factor levels at baseline and at the end of 3 months.
15994582|NCT02930343|Drug|Methotrexate|Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic diseases
15994583|NCT02930343|Drug|Leflunomide|Leflunomide inhibits pyrimidine synthesis, resulting in blockade of T-cell proliferation. Leflunomide is used in patients with moderate to severe active rheumatoid arthritis with early or late disease
15994584|NCT02930343|Drug|Hydroxychloroquine|Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine.
15994585|NCT02930343|Drug|Prednisolone|Low dose prednisolone (weeks 1-2: 7.5 mg/day, weeks 2-4: 5 mg/day, weeks 4-6: 5 mg on alternate day and then stop)
15994586|NCT02930343|Drug|Folic Acid|Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week.
15994587|NCT02930343|Drug|Sulfasalazine|5-aminosalicylic acid (5-ASA) is the active component of sulfasalazine; the specific mechanism of action of 5-ASA is unknown; however, it is thought that it modulates local chemical mediators of the inflammatory response, especially leukotrienes, and is also postulated to be a free radical scavenger or an inhibitor of tumor necrosis factor (TNF)
15994708|NCT02929498|Drug|Azacitidine|Azacitidine will be administered at 75 mg/m2 from Day 1 to Day 7 of each 28 day cycle by intravenous (iv) infusion or subcutaneous (sc) injection.
15994588|NCT02930330|Behavioral|INT|"5 min warm-up (40% Pmax*)
~30 min high intensity interval training (1 min 100% Pmax, 1 min 20% Pmax, in alternating sequence)
~10 min cool-down (30% Pmax)
~Pmax*: Maximal power output (Watt) achieved at the end of an incremental exercise test."
15994589|NCT02930330|Behavioral|CONT|"5 min warm-up (40% Pmax*)
~30 min moderate intensity continuous training (60% Pmax)
~10 min cool-down (30% Pmax)
~Pmax*: Maximal power output (Watt) achieved at the end of an incremental exercise test."
15994590|NCT02930317|Drug|Recombinant Factor VIII (50 IU/kg)|
15994591|NCT02930317|Drug|Recombinant Factor VIII (On-demand treatment)|
15994592|NCT02930304|Other|first physiotherapy|physiotherapy program consists of cold pack, Transcutaneous electrical nerve stimulation (TENS), and home exercise programme including stretching and eccentric strength exercises will be applied five times a week total 15 sessions
15994593|NCT02930304|Other|second physiotherapy|physiotherapy program consists of cold pack, Transcutaneous electrical nerve stimulation (TENS), and home exercise programme including stretching and eccentric strength exercises will be applied five times a week total 15 sessions. Kinesio taping will be applied two times per week total six times in addition to conventional physiotherapy
15994594|NCT02930304|Other|third physiotherapy|physiotherapy program consists of cold pack, Transcutaneous electrical nerve stimulation (TENS), and home exercise programme including stretching and eccentric strength exercises will be applied five times a week total 15 sessions. Extracorporeal shockwave therapy (ESWT) will be applied one times per week total three session.
15994595|NCT02930265|Drug|Liraglutide|Liraglutide intervention group will accept liraglutide (Novo Nordisk, specifications: 18mg / 3ml; 1.8mg subcutaneous injection of 1 / day)
15994596|NCT02930252|Device|Niti-S Biliary ComVi Stent|Endoscopic placement of biliary fully covered metal stents
15994597|NCT02930252|Device|Niti-S stent (D type)|Endoscopic placement of biliary uncovered metal stent
15994598|NCT02930239|Other|Gait rehabilitating with reduced bodyweight|Patients will perform 8 sessions of gait rehabilitation with reduced bodyweight using the anti gravity treadmill during week 2-5 post-surgery.
15994599|NCT02930239|Other|Standardized rehabilitation following an anterior cruciate ligament reconstruction at Linkoping University Hospital|Exercises for increased movement and circulation performed on a daily basis.
15994600|NCT02930226|Biological|Autologous Freeze Dried Plasma (FDP)|Safety of Ascending Doses of Autologous Freeze Dried Plasma (FDP) in Healthy Volunteers
15994601|NCT02930226|Biological|Fresh Frozen Plasma (FFP)|Controlled FFP in cohort 3 only
15994602|NCT02930200|Behavioral|Treatment as Usual|Tobacco Treatment Research Program (TTRP) or Treatment as Usual (TAU)
15994603|NCT02930200|Behavioral|QuitGuide|NCI QuitGuide Treatment App
15994604|NCT02930200|Behavioral|Smart-T|Smart-Treatment App
15994605|NCT02930174|Device|noninvasive positive pressure ventilation|Application of various levels of positive pressure
15994606|NCT02930161|Drug|Runihol|"Composition of Runihol®:
~One tablet contains:
~Active ingredients: succinic acid - 0.250 g; Riboxinum (inosine) - 0.100 g; taurine - 0.050 g; Methionine - 0.050 g Excipients - 0.184 g: potato starch, povidone, microcrystalline cellulose, calcium stearate, hypromellose, polysorbate-80.
~Enteric coat - 0.061 g: methacrylic acid-ethyl acrylate copolymer, talc, titanium dioxide, triethyl citrate, colloidal silicon dioxide, sodium hydrogencarbonate, sodium lauryl sulfate."
15994607|NCT02930161|Other|Placebo|"The composition of the drug in one tablet:
~Active substance: None. The tablet core - 0.634 g: potato starch, povidone, microcrystalline cellulose, calcium stearate, hypromellose, polysorbate-80.
~Enteric coat - 0.061 g: methacrylic acid-ethyl acrylate copolymer, talc, titanium dioxide, triethyl citrate, colloidal silicon dioxide, sodium hydrogencarbonate, sodium lauryl sulfate.
~Tablet weight enteric coated - 0.695 g"
15994608|NCT02930148|Other|PEGASO System (ICT based system/mHealth solution)|"Participants will be provided with a smart phone with the PEGASO system and will be asked to join the PEGASO community through the PEGASO Portal. Two smart garments, and two sensors will be provided at month 2 (to minimise the burden on the schools and participants allocating time and resources). The PEGASO System allows empowering the participants toward healthy habits, recording what he or she eats, monitor physical activity variables. The serious game is a central motivational component of PEGASO: it has an energy bar, used up by the player's actions, and replenished when achieving their behavioural goals, and it implements research mechanics that require the player to apply and develop their nutritional knowledge. The Bridge allows the connection between the PEGASO ecosystem and the personal health folder by creating a report to be shared with physicians"
15994609|NCT02930135|Procedure|Indirect pulp capping|Removal of superficial caries in young permanent molars that my expose tooth pulp if totally removed leaving deep carious layers to be sealed inside with two step bonding system and bulk fill composite as a final restoration
15994612|NCT02930109|Drug|PTX-200|During the Phase I study, increasing dose levels of PTX-200 will be administered as an intravenous infusion on Day 1 each cycle. Triciribine will be infused over 1 hour on Day 1 of each 21 day cycle. The initial dose level will be 25 mg/m2 and each dose level will be increased by 10 mg/m2 to a maximum dose of 55 mg/m2
15994613|NCT02930109|Drug|Cytarabine|Cytarabine will be given at a dose of 400 mg/m2 as a continuous IV infusion on days 3-7 of each cycle.
15994614|NCT02930057|Drug|Celestone|all of the patients of the experimental Celestone group will receive transforaminal epidural injection of the solution of 1 cc of Lidocaine 1% with 1 cc of Celestone® Chronodose® around each dorsal root ganglion immediately after the radiofrequency treatment has been performed
15994615|NCT02930057|Procedure|pulsed radiofrequency treatment|all of the patients who will participate in the study will receive pulsed radiofrequency treatment adjacent to lumbosacral dorsal root ganglion(s).
15994616|NCT02930057|Drug|Control|all of the patients of the control group will receive transforaminal epidural injection of the solution of 1 cc of Lidocaine 1% with 1 cc of normal saline around each dorsal root ganglion immediately after the radiofrequency treatment will be performed.
15994617|NCT02930044|Other|Early administration of subcutaneous insulin glargine dose|DKA patients in the prospective intervention arm will receive subcutaneous glargine within two hours of starting their intravenous insulin infusion. The dose of glargine is 0.3 units/kg with a maximum dose of 30 units.
15994618|NCT02930044|Other|IV insulin infusion|All patients will receive the standard of care which is a protocol based continuous insulin infusion
15994619|NCT02930044|Drug|IV fluid repletion|0.9% NaCl or Plasmalyte A will be initiated as a continuous infusion for volume repletion. Fluids will be switched to contain potassium if serum potassium is less than 3.3 mEq/L. Fluids will be switched to contain dextrose if the serum glucose is less than 250 mg/dL.
15994620|NCT02930031|Dietary Supplement|n-acetylcysteine|20 mg//kg/day, orally, daily for eight days following exercise
15994621|NCT02930031|Dietary Supplement|Placebo|500 mL orally, daily for eight days following exercise
15994622|NCT02930018|Drug|Nerinetide (NA-1), 2.6 mg/kg|Single intravenous infusion of nerinetide over 10 ± 1 minutes
15994623|NCT02930018|Drug|Placebo|Placebo Comparator: Placebo
15994624|NCT02930005|Drug|Meclofenamic acid|
15994625|NCT02930005|Drug|Pentosan polysulfate sodium|
15994626|NCT02929992|Other|ART initiation in the home|Participants initiate ART use in the home without visiting a clinic
15994627|NCT02929992|Other|Mobile Van Refill and Monitoring|Participants will pick up their medication refills from the mobile van and have all clinical monitoring conducted in the mobile van.
15994628|NCT02929992|Other|Clinic ART Initiation|Participants are referred to the clinic to initiate ART use
15994629|NCT02929992|Other|Clinic ART Refill and Monitoring|Participants will return to the clinic for ART refill and clinical monitoring.
15994630|NCT02929979|Behavioral|Cognitive Training|Participants will complete 22.5 hours of cognitive training exercises over 6-weeks (training 5 times a week) using an app-based program, BrainHQ (BPI/Posit Science, San Francisco). BrainHQ is based on a previous neuroscience-based cognitive training program shown to improve cognition in several different randomized controlled studies with other clinical populations. The investigators will use a suite of BrainHQ exercises designed to target and ameliorate cognitive disruptions in 4 cognitive domains (see main outcome). The investigators will employ basic exercises that focus on increasing processing efficiency in the auditory and visual perceptual and working memory domains, as well as exercises that target impulsivity and cognitive biases. Exercises will be packaged into 4 modules (attention skills, memory skills, executive functioning skills, cognitive control skills) comprised of 4 exercises each. All participants will progress through the same fixed schedule of modules.
15994631|NCT02929979|Behavioral|Cognitive training placebo control|Participants will play a rotating set of commercial computer games at the same dose and frequency as the cognitive training. The investigators selected this control activity because it mirrors the game-like properties of the cognitive training and it will be used to control for contact with research personnel and for the non-specific effects of participant motivation and engagement with daily computerized activities. It also allows for a double blind study design. Games from the website Sporcle will be used and an online account can be created for each participant.
15994632|NCT02929966|Other|palliative care program|The program includes psychological support, spiritual care and respiratory therapist support
15994633|NCT02929966|Other|standard respiratory care|the usual standard pharmacological care plus oxygen therapy
15994634|NCT02929953|Other|chart review|data from charts and from registries will be compared
15994635|NCT02929940|Other|No intervention|No Intervention, observational
15994636|NCT02929927|Procedure|Rubber dam isolation|tooth was isolated using a rubber dam in order to avoid the outside microbe
15994637|NCT02929927|Device|aPDT|Inject the photosensitizer (PS)to the parallel orifice of the canal,use the small file to stir the PS for 60 s,then irradiation 120 s.
15994638|NCT02929927|Drug|tooth disinfection|use 1% iodine tincture to disinfect the crown of the teeth.in order to avoid the outside microbe
15994639|NCT02929927|Drug|2.5%NaClO|use 2.5% NaClO as irrigants
15994640|NCT02929927|Procedure|root canal preparation|mechanical preparation with NITIMTWO to 25#06, and cleaned with 5 ml of 2.5% NaClO between each endodontic file. At the end of the procedure, root canals were ultrasonic irrigated with 2.5% NaClO, 17% EDTA for 1 min followed by irrigation with 0.9% normal saline to remove the smear layer
15994641|NCT02929927|Procedure|root canal obturation|filled the canals with AH-Plus sealer and Gutta-percha by vertical condensation
15994642|NCT02929914|Procedure|Local anesthesia and rubber dam isolation|Local anesthesia was performed. Tooth was isolated using a rubber dam isolation in order to collect the dentin samples.
15994643|NCT02929914|Procedure|Incomplete caries removal and microbiological samples collection|Partial carious tissue was removed with conventional dentinal curette and collection of dentin with a spoon (1#) was performed.
15994644|NCT02929914|Procedure|Dentin washed with sodium 0.9% saline|The remaining dentin was dipped in sodium 0.9% saline for 2min.
15994645|NCT02929914|Procedure|Antimicrobial Photodynamic Therapy|The remaining dentin was disinfected with aPDT for 2 min.
15994646|NCT02929914|Procedure|Microbiological samples collection and Indirect pulp treatment|A new dentin collection was performed after this treatment at another site of the cavity. Then teeth were conventionally restored using the following materials: calcium hydroxide lining material and resin (Z350,3M).
15994647|NCT02929901|Dietary Supplement|caffeine and chlorogenic acid|caffeine plus chlorogenic acid
15994648|NCT02929901|Dietary Supplement|caffeine|caffeine plus placebo
15994649|NCT02929901|Dietary Supplement|chlorogenic acid|chlorogenic acid plus placebo
15994650|NCT02929901|Dietary Supplement|placebo|placebo plus placebo
15994651|NCT02929888|Drug|Lysine Acetilsalicilate|
15994652|NCT02929888|Drug|Aspirin|
15994653|NCT02929875|Behavioral|Education based on TPB|Three Training sessions were given to the case group; each lasted for one hour, during a period of twenty days. During each one-hour training session a period of 45 minutes was dedicated to listening to lectures, having discussions, and discussing methods of using teaching aids such as pamphlets and manuals. The last 15 minutes was used to summarize issues and answer questions.
15994654|NCT02929862|Drug|LYC-55716|For Phase 1, increasing doses of oral 55716 given BID for a 28 day cycle. For Phase 2A, the RP2D will be administered to patients for 28 day cycles.
15994655|NCT02929849|Dietary Supplement|300 mg SC|Salacia (T1) capsule given with breakfast (mixed meal tolerance test)
15994656|NCT02929849|Dietary Supplement|500 mg SC|Salacia (T2) capsule given with breakfast (mixed meal tolerance test)
15994657|NCT02929849|Dietary Supplement|Placebo|Placebo capsule given with breakfast (mixed meal tolerance test)
15994658|NCT02929836|Procedure|PVI|PVI was the complete isolation of all PVs, which was confirmed by entrance and/or exit block into or from the PV antra.
16028483|NCT02677545|Drug|Aspirin|
15994659|NCT02929836|Procedure|LA linear ablation|LA linear ablation include mitral isthmus ablation and roof line ablation. Mitral isthmus ablation (from the mitral annulus to the left inferior PV) was performed first, followed by roof line ablation (between the right and left superior PVs).
15994660|NCT02929836|Procedure|CFAE ablation|Ablation catheter was maintained in a stable position when the electrograms were being recorded for at least 5 s to avoid artifacts.The procedural endpoint of CFAEs was the complete elimination of fragmented atrial activity in local electrograms.
15994661|NCT02929836|Procedure|linear ablation|Right atrial CTI ablation was performed during SR.
15994662|NCT02929836|Device|CARTO|3 dimensional mapping system
15994663|NCT02929823|Drug|High Dose SJP-0035 Ophthalmic Solution|0.001% SJP-0035 Ophthalmic Solution
15994664|NCT02929823|Drug|Low Dose SJP-0035 Ophthalmic Solution|0.0002% SJP-0035 Ophthalmic Solution
15994665|NCT02929823|Drug|Vehicle of SJP-0035 Ophthalmic solution|0% SJP-0035 Ophthalmic Solution
15994666|NCT02929810|Behavioral|sleep extension|
15994667|NCT02929810|Behavioral|sleep maintenance|
15994668|NCT02929797|Biological|CD8+NKG2D+ AKT Cell|AKT: CD8+NKG2D+ AKT cell
15994669|NCT02929797|Drug|Gemcitabine|gemcitabine
15994670|NCT02929784|Device|Intervention|Device: neuroConn_CE_DC-STIMULATOR. Anodal stimulation to affected hemisphere.
15994671|NCT02929784|Device|Sham|no meaningful stimulation will be given.
15994672|NCT02929771|Device|Samsung GearVR|VR with head mounted display (HMD) and headphones. Treatment
15994673|NCT02929771|Device|iPad|iPad with headphones. Control
15994674|NCT02929758|Behavioral|Speed of processing training (SOPT)|This is a game-like program designed based on the UFOV. It consists of five activities (Sweep Seeker, Bird Safari, Jewel Diver, Master Gardener, and Road Tour). The duration of training will be 3 months. Participants will be encouraged to train at least three-times weekly for 1-hour blocks and must complete at least 20 training sessions over the course of the three months.
15994675|NCT02929745|Procedure|Skin biopsy|Four 4-5 mm punch biopsies of the skin
15994676|NCT02929745|Procedure|Blood draw|Blood will be drawn to test for HLA-cw6 status
15994677|NCT02929732|Other|Sympathetic nervous activity measurement|Polysomnography, MIBG myocardic scintigraphy, and 24h blood pressure measurement
15994678|NCT02929719|Drug|Test.|gel
15994679|NCT02929719|Drug|Aczone Gel 5%|gel
15994680|NCT02929719|Drug|Placebo|gel
15994681|NCT02929706|Genetic|Pre-genotype NUDT15 and optimize azathioprine dosage|Pre-genotype NUDT15 and optimize azathioprine dosage.The wild type use azathioprine(Imuran，2-2.5mg/kg/d),the CT genotype use half dose of azathioprine（Imuran，1-1.5mg/kg/d).The TT genotype avoid use of azathioprine.
15994682|NCT02929693|Drug|gefitinib|250 mg oral once a day until progression or unacceptable toxicity develops
15994683|NCT02929693|Drug|Yiqi-yangyin-jiedu decoction|Yiqi-yangyin-jiedu decoction is a traditional chinese herbal medicine formula,and should be taken one package, twice a day, until progression or unacceptable toxicity develops.
15994684|NCT02929693|Drug|placebo|Oral granules, which the taste and smell are similar to YYJD, has no therapeutic effect, Oral granules, which the taste and smell are similar to experimental TCM granules, has no therapeutic effect, one package, twice a day, until progression or unacceptable toxicity develops.
15994685|NCT02929667|Drug|Fluoxetine|Standard 6 weeks titration, starting 10 mg per day.
15994686|NCT02929667|Drug|Placebo|Standard 6 weeks titration.
15994687|NCT02929654|Device|OneTouch Verio®|Colour Enhanced Blood Glucose Meter.
15994688|NCT02929654|Device|OneTouch Verio® Flex|Colour Enhanced Blood Glucose Meter.
15994689|NCT02929654|Device|Subject's Own Blood Glucose Meter|Subject's Own Blood Glucose Meter
15994690|NCT02929628|Device|Beijing PINS Programming|Using the programming control the Stimulator to change the parameter
15994691|NCT02929615|Other|Hematopoietic stem cell transplantation|
15994692|NCT02929589|Drug|Ibuprofen|ibuprofen 800 milligrams by mouth every 8 hours as needed for pain for 5 days
15994693|NCT02929589|Drug|Opioid Medication|1 to 2 tablets of oxycodone/acetaminophen 5 milligrams/325 milligrams (Qty. 30) by mouth every 4 hours as needed for pain for 5 days
15994694|NCT02929589|Drug|Placebo|800 milligrams of a placebo pill (containing corn starch) to be taken by mouth every 8 hours as needed for pain
15994695|NCT02929589|Drug|Ibuprofen + Opioid medication|ibuprofen 800 milligrams by mouth every 8 hours as needed for pain for 5 days. 1 to 2 tablets of oxycodone/acetaminophen 5 milligrams/325 milligrams (Qty. 30) by mouth every 4 hours as needed for pain for 5 days
15994696|NCT02929576|Drug|Enzalutamide|Enzalutamide will be administered as four 40-mg capsules once daily (160 mg/day).
15994697|NCT02929576|Drug|Placebo|
15994698|NCT02929576|Drug|Paclitaxel|Paclitaxel (90 mg/m2) will be administered by constant-rate intravenous infusion of ≤ 1 hour once weekly for 16 weeks. Dose reductions or alterations to the schedule are allowed to maintain patient safety.
15994699|NCT02929563|Drug|Pantoprazole|
15994700|NCT02929563|Drug|Placebo (for pantoprazole)|
15994701|NCT02929550|Other|Well-controlled|Both groups got treatment but well-controlled reached target of LDL-C<1.8 mmol/l
15994702|NCT02929524|Drug|Ketamine|As indicated the use of sedative and after authorization of the person responsible, the child receives the intranasal solution. Before administration of the solution 2 hour and 24 hours after the procedure, must be recorded vital signs of the patient. A person with the help of a clock will make the time count. The nurse and the patient's family must respond to the study protocol questions
15994703|NCT02929524|Drug|Placebo|As indicated the use of sedative and after authorization of the person responsible, the child receives the intranasal solution. Before administration of the solution 2 hour and 24 hours after the procedure, must be recorded vital signs of the patient. A person with the help of a clock will make the time count. The nurse and the patient's family must respond to the study protocol questions
15994704|NCT02929511|Procedure|Reciprocating single-file system|The device is moving in CW and CCW direction with different angles. It is a single-file endodontic file. The intervention is Reciproc Blue reciprocating single-file system.
15994705|NCT02929511|Procedure|Rotational single-file system.|The device is moving in continuous rotational. It is a single-fie endodontic file.
15994706|NCT02929511|Procedure|Active comparator Protaper multi-file system|
15994707|NCT02929498|Drug|GSK2879552|GSK2879552 will be administered orally as continuous daily dosing.
15994711|NCT02929485|Drug|Bromocriptine|Drug: Bromocriptine 1.25 mg (single dose) administered at study visit
15994712|NCT02929472|Behavioral|Physical exercise|The intervention group (INT, n = 17, 7 boys) who attended at least 75% of PA classes and met more than 50% of food goals.The exercise sessions took 90 minutes, in order to assure at least 60 minutes of physical exercise, during 12 weeks. The sessions were always taught by the same staff, and were composed of: 10 minutes of warm-up; 30 minutes of circuit training; 15-minute of pre-sports and recreational games;and 5 minutes resting activities.
15994713|NCT02929472|Behavioral|without physical exercise|The control one (CONT, n = 18, 6 boys), with a minimum or less than 49% attendance in PA classes, and were not involved in the nutrition education program.
15994714|NCT02929459|Dietary Supplement|Riboflavin Dose 1|
15994715|NCT02929459|Dietary Supplement|Riboflavin Dose 2|
15994716|NCT02929459|Other|Placebo|
15994717|NCT02929446|Procedure|Mobilisation|Mobilisation out of bed to sit in an armchair or on the bedside, instructed to sit as long as possible
15994718|NCT02929446|Procedure|Mobilisation and breathing exercises|Mobilisation out of bed to sit in an armchair or on the bedside, instructed to sit as long as possible and breathing exercises with PEP
15994719|NCT02929433|Other|Cycloergometer|Daily training of the RCT patients was provided by the use of a cycloergometer at home. Educational support once a month was guaranteed by a nurse of the telemedicine service
15994720|NCT02929420|Drug|Xiaoru Sanjie capsules|Oral medication for a total of 90 days. According to the instructions, P.O., three times a day, each time three tablets, take a month as a treatment course, continuous use of 3 courses.
15994721|NCT02929420|Drug|Xiao Yao pills|Oral medication for a total of 90 days. According to the instructions, P.O., three times a day, each time three tablets, take a month as a treatment course, continuous use of 3 courses.
15994722|NCT02929407|Drug|FE 204205|"In Part 1 of the trial, each subject will receive increasing IV doses of FE 204205, given once daily as 2 hour infusion, on three consecutive days.
~In Part 2 of the trial, each subject will receive a 2 hour IV infusion of the maximum tolerated dose of FE 204205 as defined in Part 1 of the trial."
15994723|NCT02929407|Drug|Placebo|In Part 2 of the trial, each subject will receive a 2 hour IV infusion of placebo.
15994724|NCT02929394|Drug|Trabectedin|Trabectedin 1.2 mg/m² through a central venous catheter as an IV infusion over 24 hours every 4 weeks until disease progression (RECIST 1.1) or unacceptable toxicity
15994725|NCT02929381|Device|Innovative colonoscopy (Olympus CF-HQ190L, NBI + Dual Focus)|NBI and Dual Focus options will be used to classify lesions according to Kudo and NICE classifications.
15994726|NCT02929381|Device|Conventional colonoscopy (Olympus CF-H180DL)|Conventional colonoscopy performed without innovative techniques used in experimental arm.
15994727|NCT02929368|Device|PICC implantation under fluoroscopy|PICC Catheter implantation
15994728|NCT02929368|Device|PICC Implantation under Sherlock System|PICC Catheter implantation
15994729|NCT02929355|Other|carotid assesment by duplex ultrasonography|
15994730|NCT02929342|Drug|Pitolisant|
15994731|NCT02929342|Radiation|[14C]-Pitolisant|
15994732|NCT02929329|Drug|Omecamtiv Mecarbil|Omecamtiv mecarbil tablets for oral administration
15994733|NCT02929329|Drug|Placebo|Matching placebo tablets
15994734|NCT02929329|Drug|Standard of Care|Participants were required to be optimally managed with standard of care therapies for chronic HF (eg, beta blockers, renin angiotensin aldosterone system inhibitors), consistent with regional clinical practice guidelines, unless contraindicated.
15994735|NCT02929316|Drug|Vedolizumab|IV infusion week 0, 2 and 6
15994736|NCT02929303|Drug|Omegaven IV lipid emulsion|Therapy is started at a dose of 1 gm/kg/day over 12 hrs. Omegaven may be infused via a central or peripheral IV. If additional fat calories are needed they will be provided by the enteral route.
15994737|NCT02929290|Drug|BPI-9016M|"Part I：Four dose cohorts will be evaluated, including 300mg, 450mg, 600mg, 800mg. BPI-9016M Tablet will be administered orally to patients once daily for each dose cohort.
~Part II：400mg BPI-9016M Tablet will be administered orally to patients twice a day."
15994738|NCT02929277|Other|blood sampling, skin prick tests, assesment of atopic dermatitis, questionnaires|
15994739|NCT02929264|Drug|ABX-1431|Capsules, 40 mg, single dose
15994740|NCT02929264|Drug|Placebo|Capsules, single dose
15994741|NCT02929251|Drug|Anakinra|Anakinra (100 mg/day subcutaneously) (n=40) for 16 weeks
15994742|NCT02929251|Drug|Tocilizumab|Tocilizumab (162 mg/7 days subcutaneously) (n=40) for 16 weeks.
15994743|NCT02929251|Drug|Adalimumab|Adalimumab (40mg/14 days subcutaneously) (n=40) for 16 weeks
15994744|NCT02929238|Other|Polypropylene Suture Right Side|Suture Description: The suture used in this study will be a sterilized polypropylene suture and individually crossed in the base of the wound. Polypropylene is commonly used for commercially available implanted meshes. The polypropylene suture is intended for single use only and the individual suture will be packaged and purchased sterile.
15994745|NCT02929238|Other|Polypropylene Suture Left Side|Suture Description: The suture used in this study will be a sterilized polypropylene suture and individually crossed in the base of the wound. Polypropylene is commonly used for commercially available implanted meshes. The polypropylene suture is intended for single use only and the individual suture will be packaged and purchased sterile.
15994746|NCT02929225|Drug|Bifid Triple Viable Capsules|BIFICO is prescribed as a dose of 4 capsules twice daily in half hours after meals.
15994747|NCT02929225|Other|placebo|placebo is also prescribed as a dose of 4 capsules twice daily
15994748|NCT02929212|Other|Solid Meal|Subjects will receive solid meals during meal study
15994749|NCT02929212|Other|Liquid Meal|Subjects will receive liquid meals, during meal study
15994750|NCT02929212|Drug|Acetaminophen|All subjects given acetaminophen to measure gastric emptying
15994751|NCT02929212|Other|Single, 600 kcal meal|Subjects will receive a single, 600 kcal meal during meal study
15994752|NCT02929212|Other|Multiple, 200 kcal meals|Subjects will receive three, 200 kcal meals, during meal study
15994753|NCT02929199|Other|All ceramic crown|Pressed E-Max coping veneered with E-max veneering system
15994754|NCT02929199|Other|Hybrid crown|pressed Bio HPP veneered with Visio-Lign Veneering system
15994862|NCT02928367|Other|rectal swab|rectal swab at baseline visit (2x) and at day 28 (2x) OR rectal swab at single timepoint (2x) (healthy volunteers)
16030111|NCT02665364|Other|ISA 51 VG|
15994755|NCT02929186|Behavioral|Opt-In Outreach|Subjects will receive a communication (mail or electronic) describing the importance of colorectal cancer screening with the option to elect to receive a home FIT kit or report prior screening.
15994756|NCT02929186|Behavioral|Opt-Out Outreach|Subjects will receive a communication (mail or electronic) describing the importance of colorectal cancer screening with the option to choose not to receive a home FIT kit or report prior screening. A FIT kit will otherwise be sent to the subject as a default.
15994757|NCT02929173|Other|Allceram|Pressed E-max coping veneered with E-max veneering system
15994758|NCT02929173|Other|hybrid crown|pressed Bio HPP coping veneered with visolign veneering system
15994759|NCT02929160|Procedure|Percutaneous nephrostomy|Percutaneous nephrostomy tube insertion under radiological guidance
15994760|NCT02929160|Procedure|Retrograde ureteric JJ stent|Retrograde ureteric JJ stent insertion using cystoscopy
15994761|NCT02929147|Drug|Morphine|In the Group 1 the PCA will set to administer a bolus dose of 1 mg morphine on demand with a lockout period of 10 minutes and maximum 20 mg for 4 hours. In the Group 2 the PCA set to administer a bolus dose of 0.5 mg morphine on demand with a lockout period of 10 minutes and maximum 20 mg for 4 hours.
15994762|NCT02929147|Drug|Dexketoprofen|The Group 3 will take 50 mg dexketoprofen in the recovery room. Intra venous injections of dexketoprofen will repeat every 8 hours.
15994763|NCT02929147|Drug|Placebo|In the Group 3 the PCA will contain placebo.
15994764|NCT02929134|Drug|Doxycycline|Once daily tablet for 6 weeks: Doxycycline hyclate 200 mg per day x 6 weeks for patients >50 kg or 100 mg per day for patients <50 kg)
15994765|NCT02929134|Drug|Placebo|Once daily tablet for 6 weeks: matching tablets containing no active ingredients
15994766|NCT02929121|Drug|Doxycycline|Once daily tablet for 6 weeks: Doxycycline hyclate 200 mg per day x 6 weeks for patients >50 kg or 100 mg per day for patients <50 kg)
15994767|NCT02929121|Drug|Placebo|Once daily tablet for 6 weeks: matching tablets containing no active ingredients
15994768|NCT02929108|Behavioral|Facebook|Participants will be enrolled in a Secret Facebook group for social support and education
15994769|NCT02929108|Behavioral|ACCESS|"Intervention will have two components.
~Participants will be enrolled in a Secret Facebook group for social support and education
~Participants will use web conferencing technology to participate in their interdisciplinary team meeting"
15994770|NCT02929095|Drug|dexmedetomidine|
15994771|NCT02929095|Drug|midazolam|
15994772|NCT02929095|Drug|remifentanil|- remifentanil will be administered to both dexmedetomidine and midazolam group as a routine part of procedure and it is no of interest of the protocol
15994773|NCT02929082|Radiation|IRM with a 5-minute- additional sequence to measure FRM|IRM with a 5-minute- additional sequence to measure FRM for patients in group 1,2 and 3
15994774|NCT02929069|Behavioral|ESTEEM|ESTEEM is a 10-session intervention based on the Unified Protocol, an individually-delivered CBT intervention with efficacy for reducing stress-sensitive mental health disorders (e.g., depression, anxiety) by enhancing emotion regulation skills; reducing avoidance patterns; and improving motivation and self-efficacy for behavior change.
15994775|NCT02929069|Behavioral|CMHT|CMHT is the current standard of care for LGB individuals who seek mental, behavioral, or sexual health care is LGB-affirmative therapy.The practice of LGB-affirmative therapy is outlined across 21 guidelines published by the American Psychological Association.
15994776|NCT02929069|Behavioral|VCT|Voluntary Counselling and Testing (VCT).
15994777|NCT02929056|Device|AmnioExCel dressing and compression therapy|Use of a dehydrated human amnion membrane as a biologic adjunct to the standard of care in patients with venous leg ulcers
15994778|NCT02929056|Device|SOC alginate dressing and compression therapy|Alginate dressing is an absorbent wound care product that contains sodium and calcium fibers to absorb fluids and promote healing
15994779|NCT02929043|Other|air puffs|
15994780|NCT02929030|Device|Nano|The stent system comprises of 2 components: stent steel platform, antiproliferative drug sirolimus, and stent balloon
15994781|NCT02929017|Other|SUPPORT|Members of this group will receive personal, enhanced printed materials, as well as face-to-face support, and digital information provided by the interventionist.
15994782|NCT02929017|Other|Currently Available Printed Material|Subjects will receive their usual standard of care, including currently available printed patient material.
15994783|NCT02929004|Device|Vibrasens|Transcutaneous vibrations are used. This device allows vibrations from 25 to 150 Hz with an amplitude of 1 mm. In our study the frequency used is 50 Hz.
15994784|NCT02928991|Other|MRD-BMT with Fludarabine-based RIC for Acquired AA|"Fludarabine: Dose: 30mg/m2/day (<10kg will receive 1mg/kg/day) Days: -7, -6, -5, -4, -3
~Cyclophosphamide: Dose: 60mg/kg/day Days: -5, -4
~Thymoglobulin: Dose: 3mg/kg/day Days: -4, -3, -2
~Bone marrow infusion: Day 0"
15994785|NCT02928991|Other|MRD-BMT with Fludarabine-based RIC for iBMF with trilineage aplasia|"Fludarabine: Dose: 30mg/m2/day (<10kg will receive 1mg/kg/day) Days: -7, -6, -5, -4, -3
~Cyclophosphamide: Dose: 10 mg/kg/day Days: -6, -5, -4, -3
~Thymoglobulin: Dose: 3mg/kg/day Days: -4, -3, -2
~Bone marrow infusion: Day 0"
15994786|NCT02928991|Other|MRD-BMT with Fludarabine-based RIC for iBMF without trilineage aplasia|"Fludarabine: Dose: 30mg/m2/day (<10kg will receive 1mg/kg/day) Days: -6, -5, -4, -3, -2
~Busulfan: Dose: every 6 hours for a total of 12 doses with dosing adjustments to achieve a steady state concentration of 900-1200ng/mL OR daily for a total of 3 doses targeting AUC 3600-6000 (micromole/liter)*minute Days: -7, -6, -5, -4
~Thymoglobulin: Dose: 3mg/kg/day Days: -10, -9, -8
~Bone marrow infusion: Day 0"
15994787|NCT02928978|Drug|Ruxolitinib|ruxolitinib tablet
15994788|NCT02928978|Drug|Placebo (for Ruxolitinib)|placebo tablet
15994789|NCT02928965|Drug|Minocycline|Capsules containing 100mg minocycline (modified release), administered orally by the patient, two per day for the first two weeks and then three per day for the reminder of the 12 month treatment period in addition to standard therapy.
15994790|NCT02928965|Drug|Placebo|Matching placebo with appearance of over - encapsulated minocycline
15994791|NCT02928952|Behavioral|Mind-STRIDE|Mindful Stress Reduction in Diabetes Education- mindfulness training with home practice will be introduced as part of diabetes education
15994792|NCT02928939|Other|drug-drug or drug-disease interaction|
15994793|NCT02928926|Other|intravenous thrombolysis|patients who are eligible with intravenous thrombolysis or admitted within the timeframe to receive thrombolysis but not eligible due to other reasons
15994794|NCT02928913|Other|No intervention|
15994795|NCT02928900|Behavioral|Clinician training intervention|This intervention is a clinician training using SP actors to improve communication and empathy skills of HIV care providers who serve HIV-positive adolescents and youth in Kenya.
15994796|NCT02928887|Other|Blue light|Exposure to high illuminance (1000 lux), blue spectrum (480 nm) light for a 24-hour photoperiod immediately before surgery and a 24-hour photoperiod immediately after surgery
15994797|NCT02928874|Behavioral|% COMPX (low ED vs. high ED preload)|
15994798|NCT02928874|Behavioral|EAH (low ED vs. high ED snacks)|
15994799|NCT02928861|Device|18F-FDG PET/CT|18F-FDG PET/CT will be conducted before, during and after chemotherapy. Patients were instructed to fast for at least 6 h before PET. The blood glucose level was measured to ensure that it was <200 mg/ dL. 18F-FDG was intravenously administered at a dose of 3.7 MBq/kg. Approximately 60 ± 10 min post- injection, a whole-body acquisition commenced in 6-8 bed positions (1 min/bed) using a hybrid system (PHILIPS Gemini TF) and covered from the base of the skull to the upper thigh, which was followed by CT in a non-contrast phase (modulated 100 mAs; 120 kV; slice thickness, 3 mm) for attenuation correction and anatomical localization purposes. The head acquisition was performed in one bed position (8-10 min/bed).
15994800|NCT02928848|Device|transcranial direct current stimulation|Transcranial direct current stimulation (tDCS) is a type of noninvasive brain stimulation that modulates the resting excitability of neuronal populations, thereby altering patterns of brain activity in potentially behaviorally relevant ways. The stimulation involves 20 minutes of constant stimulation at 1.5 mA.
15994801|NCT02928835|Device|Knee flexion Dynasplint orthosis|Standardized rehabilitation procedures started at the first day after total knee arthroplasty. Both groups received the same standardized physical therapy intervention. The experimental group used the knee flexion Dynasplint orthosis (Dynasplint Systems, Inc. Canada, Woodbridge, ON) at night, while sleeping, over six continuous hours for one month, starting seven days after the total knee arthroplasty. The control group received only the standardized physical therapy intervention.
15994802|NCT02928822|Behavioral|VR-based sensorimotor aphasia therapy|VR-based sensorimotor aphasia therapy. 8 weeks, 1 session a week, 30min-1h per session of language and motor therapy using using VR rehabilitation gaming system. The patients will play in pairs.
15994803|NCT02928822|Behavioral|Control Group (conventional aphasia rehabilitation)|8 weeks, 1 session a week, 30min-1h per session of conventional aphasia rehabilitation training the same vocabulary as the experimental group.
15994804|NCT02928809|Device|low-level laser therapy|Three points will be irradiated over the masseter muscle (upper, middle and lower bundles) and one point will be irradiated over the anterior temporal muscle of each side of the face in the groups submitted to pre-fatigue laser. The following parameters will be employed: wavelength: 780 nm; energy density: 25 J/cm2; output power: 50 mW; power density: 1.25 W/cm2; and exposure time: 20 seconds per points, resulting in a total energy of 1 J per point. The laser will be applied punctually with a conventional tip in contact with the skin considering an area of 0.04 cm2.
15994805|NCT02928809|Other|Placebo comparator|The same equipment will be used in the placebo group, but with a pen that emits a red guide light and a warning sound, but without the emission of a laser beam.
15994806|NCT02928796|Behavioral|Cognitive Stimulus|Participants to pay attention to a supplementary display monitor and respond to specified stimulus images, all while performing the simulated cardiology-based procedure.
15994807|NCT02928783|Behavioral|Home-based cardiac rehabilitation|
15994808|NCT02928770|Device|Nastent|Use of the device while at home and in the sleep lab
15994809|NCT02928757|Other|Complex care clinic as part of the CCKO initiative|"The CCKO intervention involves intensive care coordination, defined as: deliberate organization of patient care activities between two or more participants (including the patient) involved in a patient's care to facilitate the appropriate delivery of health care services. Organizing care involves marshaling of personnel and other resources needed to carry out all required patient care activities and is often managed by the exchange of information among participants responsible for different aspects of care. Within CCKO, intensive care coordination will specifically include: 1) the tailored, family/health care provider co-creation and regular updating of care coordination plans for each child which will be 2) facilitated and accounted for by key workers partnering with families."
15994810|NCT02928744|Other|COPD|Plethysmography
15994811|NCT02928744|Other|COPD|Forced oscillations
15994812|NCT02928731|Other|Questionnaires set 1|Participants were asked to respond to the Chinese version of the Coping Behavior Checklist for Chinese Children, the Chinese University of Hong Kong: Physical Activity Rating for Children and Youth, and the Pediatric Quality of life Inventory: cancer module.
15994813|NCT02928731|Other|Questionnaires set 2|Participants were asked to respond to the Chinese version of the Chinese University of Hong Kong: Physical Activity Rating for Children and Youth,and the Pediatric Quality of life Inventory: generic module
15994814|NCT02928718|Procedure|ERCP|Two expert endoscopists will perform ERCP. Patients will be sedated with midazolam(2-5mg) and pethidine(25-50mg) with careful monitoring. Duodenoscope (TJF-240 or TJF-260; Olympus Corp., Tokyo, Japan) will be used. Cholangiography or pancreatography will be gathered after selective bile duct or pancreatic duct cannulation. Therapy such as endoscopic sphincterotomy, stent insertion, and etc., will be done.
15994815|NCT02928705|Procedure|physician operated telemedical prehospital analgesia|Ambulances in the EMS of the city of Aachen are equipped with a portable telemedicine system. In emergencies requiring intravenous analgesia paramedics can use this system to contact the tele-EMS physician with an audio-connection. Vital parameters (e.g., ECG, pulse oximetry, non-invasive blood pressure) can be transferred in real-time. The transmission of still pictures - taken with an official smartphone - and video streaming from the inside of the ambulance are also possible. The tele-EMS physician supports the paramedics and can delegate the application of morphine and other analgesics based on two predefined algorithms for trauma and non-trauma cases that are displayed on a context-sensitive telemedical documentation system in the teleconsultation center.
15994816|NCT02928705|Procedure|prehospital analgesia by on-scene EMS physicians|This (control) group represents the conventional treatment in German emergency medical service (EMS). In addition to an ambulance manned with paramedics, a prehospital EMS physician is deployed to conduct analgesic treatment on-scene. Treatment data for this group are selected from the time period before implementing teleconsultation in routine and therefore represent a historical control group.
15994817|NCT02928692|Drug|Minocycline|
15994818|NCT02928692|Drug|Placebo|
15994819|NCT02928679|Drug|Liraglutide 3 mg (Saxenda)|
15994821|NCT02928666|Other|DSS for mitigating interactions between recommendations|DSS that detects and mitigates interactions between recommendations, proposing a set of non-conflicting guideline recommendations
15994822|NCT02928653|Dietary Supplement|Beverage|Participants will receive 1.25 - 1.75 L of sweetened beverage a day for 12 weeks
15994823|NCT02928640|Device|ClariCore System|Data collection to build the prostrate tissue classification algorithm.
15994824|NCT02928627|Other|Analysis of microRNA expression|sample analysis
15994825|NCT02928614|Drug|Liraglutide 3 mg (Saxenda)|
15994826|NCT02928614|Drug|Liraglutide 3 mg placebo|
15994827|NCT02928601|Drug|Ondansetron|After spinal anesthesia, half of the patients will be given intravenous 8 mg ondansetron.
15994828|NCT02928601|Drug|Saline|After spinal anesthesia, half of the patients will be given intravenous 2 mlt saline.
15994829|NCT02928575|Drug|Sunitinib|Before concurrent treatment, patients will receive sunitinib orally at a dose of 12.5 mg once daily for one week prior to radiation. Patients will then receive a concomitant treatment of sunitinib at a dose of 12.5 mg once daily along with temozolomide (75 mg/m2 daily) along with radiotherapy (60 Gy in 30 fractions) over a period of 6 weeks.
15994830|NCT02928575|Drug|Temozolomide|Temozolomide (75 mg/m2 daily) will be administered along with sunitinib (12.5 mg once daily) and radiotherapy (60 Gy in 30 fractions) over a period of 6 weeks. This concurrent treatment of sunitinib, temozolomide and radiotherapy is followed by a 1 month break after which the adjuvant temozolomide treatment is administered at a dose of 150/200mg/m2 daily, for 5 of 28 days over a period of 6 months.
15994831|NCT02928575|Radiation|Radiation Therapy|Patients will receive a concomitant treatment of radiotherapy (60 Gy in 30 fractions), sunitinib (12.5 mg once daily) and temozolomide (75 mg/m2 daily) over a period of 6 weeks.
15994832|NCT02928562|Other|exercise|cyclic exercise, aerobic exercise and resistant training exercise
15994833|NCT02928549|Behavioral|semi-structured interviews|
15994834|NCT02928536|Other|no intervention|This is an observational study. No intervention is considered
15994835|NCT02928523|Drug|Autologous Fecal Microbiota Transplantation|
15994836|NCT02928510|Procedure|Biospecimen Collection|Undergo biospecimen collection
15994837|NCT02928510|Procedure|Colonoscopy|Undergo colonoscopy
15994838|NCT02928510|Procedure|Colposcopic Biopsy|Undergo colposcopic biopsy
15994839|NCT02928510|Drug|Idelalisib|Given PO
15994840|NCT02928510|Other|Laboratory Biomarker Analysis|Correlative studies
15994841|NCT02928510|Other|Pharmacological Study|Correlative studies
15994842|NCT02928510|Procedure|Physical Examination|Undergo physical examination
15994843|NCT02928510|Procedure|Sigmoidoscopy|Undergo sigmoidoscopy
15994844|NCT02928497|Device|WATCHMAN LAAC Device Implant|WATCHMAN LAAC Implant
15994845|NCT02928497|Drug|Single Antiplatelet Therapy or No Therapy (Control)|Single Antiplatelet Therapy or No Therapy at the discretion of the study physician.
15994846|NCT02928484|Dietary Supplement|Probiotic mix CBP-004019/C|One capsule per day of the probiotic mix CBP-004019/C during one month.
15994847|NCT02928484|Dietary Supplement|Placebo|One capsule per day of the placebo (maltodextrin) during one month.
15994848|NCT02928471|Dietary Supplement|Intensive dietary intervention|Participants receive a hypo-caloric formula diet containing 800 to 1,000 kcal/day. The formula diet consists of ready-to-use meal bars and powders to mix with water to make shakes, soups, or porridge. The weight loss programme consists of an 8-week period with full meal replacement by a standard liquid energy intake protocol. To facilitate compliance with the programme, participants will be scheduled for weekly facility-based group sessions with 6-8 participants led by a dietician. The recommendations for daily nutrient intake will be met.
15994849|NCT02928458|Drug|Omnipaque|
15994850|NCT02928458|Drug|MD-Gastroview|
15994851|NCT02928445|Drug|RVT-101 35 mg|once daily, oral, 35-mg tablets
15994852|NCT02928445|Drug|RVT-101 70 mg|once daily, oral, 35-mg tablets
15994853|NCT02928432|Drug|Steroids switch|Change of prednisone 5mg/12h to dexamethasone 0.5mg/24h
15994854|NCT02928419|Drug|Eltrombopag/Revolade|"From day 1, patients presenting with PLT counts ≤ 100 Gi/L at any time will receive oral eltrombopag for a maximum of 36 months.
~Starting dose will depend on PLT count determined on the day of first dose of eltrombopag. For patients experiencing PLT count 70 to 100 Gi/L, initial dosing is 50 mg/day. For subjects presenting with PLT counts < 70 Gi/L initial dosing is 100 mg/day. The dose of study medication must be increased sequentially by 50 mg every 7 days, up to a maximum dose of 300 mg/day until PLT ≥ 100 Gi/L. For East Asian subjects, a maximum dose of 150 mg is permitted."
15994855|NCT02928419|Other|Placebo|"From day 1, patients presenting with PLT counts ≤ 100 Gi/L at any time will receive oral placebo for a maximum of 36 months.
~Starting dose will depend on PLT count determined on the day of first dose of placebo. For patients experiencing PLT count 70 to 100 Gi/L, initial dosing is 50 mg/day. For subjects presenting with PLT counts < 70 Gi/L initial dosing is 100 mg/day. The dose of study medication must be increased sequentially by 50 mg every 7 days, up to a maximum dose of 300 mg/day until PLT ≥ 100 Gi/L. For East Asian subjects, a maximum dose of 150 mg is permitted."
15994856|NCT02928419|Drug|Lenalidomide|All patients will receive oral lenalidomide 10 mg/day for 21 days every 28 days. Patients will receive lenalidomide dosing according to the lenalidomide product information. Patients obtaining an erythroid response according to IWG 2006 criteria within the first 24 weeks will continue lenalidomide treatment until progression or other reasons for permanent discontinuation
15994858|NCT02928393|Drug|Basmisanil|Basmisanil immediate-release granules at a dose of 240 mg will be given orally twice daily for 90 days.
15994859|NCT02928393|Drug|Placebo|Placebo matched to basmisanil immediate-release granules will be given orally twice daily for 90 days.
15994860|NCT02928380|Device|Experimental Denture Adhesive|Participants received a single application of test denture adhesive with a Flat Ribbon Nozzle as 3 Continuous strips those were applied to upper denture and one continuous strip that was applied to the lower denture which were placed in the mouth.
15994861|NCT02928380|Device|Reference (Marketed) Denture Adhesive|Participants received a single application of marketed denture adhesive with a flat ribbon nozzle as a 3 dabs those were applied to upper denture and 2 dabs those were applied to lower denture, which were placed in the mouth.
16031263|NCT02657343|Drug|Fulvestrant|
15994863|NCT02928367|Other|nasopharyngeal swab|nasopharyngeal swab at baseline visit (1x) and at day 28 (1x) OR nasopharyngeal swab at single timepoint (2x) (healthy volunteers)
15994864|NCT02928367|Other|blood draw|blood draw at baseline visit (45ml) and at day 28 (45ml) (pneumonia patients) OR single blood draw (70ml) (healthy volunteers)
15994865|NCT02928354|Drug|Treatment A - AZD7594|Particle size Large as a single inhaled dose of 440 µg (nominal dose), administered via DPI
15994866|NCT02928354|Drug|Treatment B - AZD7594|Particle size Medium as a single inhaled dose of 440 µg (nominal dose), administered via DPI
15994867|NCT02928354|Drug|Treatment C - AZD7594|Particle size Small as a single inhaled dose of 440 µg (nominal dose), administered via DPI
15994868|NCT02928341|Other|Improved water supply|
15994869|NCT02928328|Drug|GABA oral solution|Oral mouth wash containing either GABA, lidocaine or distilled water will be used to decrease burning tongue pain produced by capsaicin
15994870|NCT02928328|Drug|Intramuscular GABA|The effect of intramuscular injection of GABA or lorazepam will be compared with buffered isotonic saline
15994871|NCT02928328|Drug|Pain modulation|The effect of GABA alone or in combination with lorazepam on muscle pain produced by intramuscular injection of glutamate will be assessed.
15994872|NCT02928315|Drug|Magnesium Sulfate|The patients in the study group will receive 10 mmol of magnesium sulphate (2.47 gm). Five ampoules of 500 mg of magnesium sulphate will be dissolved in 100 ml of saline solution infused intravenously over 4 hours, once daily for 3 days starting when the patient is shifted to ICU.
15994873|NCT02928315|Other|control|100 ml of saline solution infused intravenously over 4 hours, once daily for 3 days starting when the patient is shifted to ICU.
15994874|NCT02928302|Other|TVU CL screening|Transvaginal ultrasound cervical length screening
15994875|NCT02928289|Device|VISCO360 ab interno canaloplasty surgery|360 degrees of viscodilation of Schlemm's canal
15994876|NCT02928289|Device|Selective Laser Trabeculoplasty (SLT)|360 degrees of selective laser trabeculoplasty
15994877|NCT02928276|Other|RheumaKit: Prediction of the response to anti-TNFs DMARDs|
15994878|NCT02928263|Other|Non-Interventional|Other
15994879|NCT02928250|Dietary Supplement|Carnosine|Patients in intervention group received carnosine capsules orally daily
15994880|NCT02928250|Dietary Supplement|Placebo|Patients in placebo group received placebo that were similar in appearance to carnosine capsules and the administered dose was as the same schedule as carnosine.
15994881|NCT02928237|Device|transcranial direct current stimulation tDCS|A battery driven DC stimulator (neuroConn Gmbh,98693 llmenau, Germany)
15994882|NCT02928224|Drug|Encorafenib|Orally, once daily.
15994883|NCT02928224|Drug|Binimetinib|Orally, twice daily.
15994884|NCT02928224|Drug|Cetuximab|Standard of care.
15994885|NCT02928224|Drug|Irinotecan|Standard of care.
15994886|NCT02928224|Drug|Folinic Acid|Standard of care.
15994887|NCT02928224|Drug|5-Fluorouracil|Standard of care.
15994888|NCT02928211|Device|Sapphire II|A Class 1 laser device used in conjunction with the ointment to measure fluorescence emissions from the anterior segment (lens) of the eye.
15994889|NCT02928211|Drug|Aftobetin-HCl|The medical imaging agent (the ointment), Aftobetin-HCl is an amyloid binding ligand formulated into an ophthalmic ointment.
15994890|NCT02928211|Radiation|Positron Emission Tomography|Amyvid 370 MBq (10 mCi) is administered as a single bolus through a short intravenous catheter in a total volume of 10 mL.
15994891|NCT02928198|Device|ABSORB BVS|
15994892|NCT02928185|Behavioral|semi-structured interviews|
15994893|NCT02928172|Device|qCON-qNOX|Each subject will have the qCON-qNOX monitor on his/her forehead + the BIS monitor
15994894|NCT02928172|Device|BIS|Each subject will have the BIS monitor on his/her forehead + the qCON-qNOX monitor
15994895|NCT02928159|Device|Mecta spectrum 5000Q device|LAP-ST and Right Unilateral (RUL) electrode placement.
15994896|NCT02928146|Procedure|Hernia Repair|
15994897|NCT02928107|Other|Tele-HS|Patients will be given information on the Tele-HS and given access to take the screening at home or in-office, depending on arm.
15994898|NCT02928107|Other|PCP encouragement|Patients will or will not either receive PCP encouragement to do the Tele-HS.
15994899|NCT02928094|Biological|Ad5FGF-4|Ad5FGF-4 administered via intracoronary infusion using standard balloon catheter, and under conditions of transient ischemia.
15994900|NCT02928094|Biological|Placebo|Placebo buffer administered via intracoronary infusion using standard balloon catheter, without transient ischemia.
15994901|NCT02928081|Procedure|Extended lymphadenectomy|Extended lymphadenectomy with nerve tissues around CHA and the SMA and nodes around the celiac trunk and SMA (No.16a2, 16b1)
15994902|NCT02928081|Procedure|Standard lymphadenectomy|Lymph node dissection includes(LN5, LN6),(LN8a, 8b),(LN12b1, 12b2, 12c),(LN13a, 13b),(LN14a, 14b),(LN17a, 17b)
15994903|NCT02928068|Behavioral|Occupational Performance Coaching (OPC)|OPC focuses on increasing positive child-caregiver interactions and child learning opportunities in everyday routines and contexts, which positions families for improved trajectories over time. OPC capitalizes on families' strengths, while supporting caregivers in using their own resources and ideas to advance child function. Caregivers identify goals, while therapists ask reflective questions and make reflective comments, affording caregivers an opportunity to gain a deeper understanding of their own current knowledge and the impact of their strategies on their children's adaptive behavior. Thus, families generate their own solutions and are ultimately responsible for carrying out the intervention and evaluating its effectiveness.
15994904|NCT02928055|Device|Peripheral Nerve Stimulation|The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad has an embedded power source but also serves as the anode. The 1-channel stimulator outputs a biphasic current waveform with current pulse parameter ranges suitable for PNS. The percutaneous lead is inserted using an introducer (like a hypodermic needle) which is withdrawn and the lead is retained in the muscle by a barb at its tip. After a 1-week stabilization period, stimulation is initiated (daily dose is Group-dependent). Stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period is 3 weeks after which the lead will be removed. Total time of electrode implantation is no more than 29 days.
15994905|NCT02928042|Other|Lactobacillus bacteria|Antimicrobial effects of Lactobacillus bacteria (LAB) and nisin bacteriocin on pathogen bacteria and commercial strains of the same bacteria's growth rate will be investigated.
15994906|NCT02928029|Drug|Radium-223 dichloride (Xofigo, BAY88-8223)|Sequential dose escalation in Intravenous (IV) injection
15994907|NCT02928029|Drug|Placebo|Matching placebo
15994908|NCT02928029|Drug|Bortezomib|Bortezomib is administered subcutaneous (SC) (per Investigator choice ) at 1.3 mg/m2/dose
15994909|NCT02928029|Drug|Dexamethasone|Dexamethasone is administered orally at 40 mg
15994910|NCT02928016|Other|Mixed meal 1|20 adults with type 1 diabetes (T1DM) on intensive insulin treatment consumed a dish made with thick pasta, minced meat and béchamel sauce and 20 g kalamata olives. The meal provided 794 kcal and contained approximately 500 kcal from protein and fat. Insulin requirements for the test meal were calculated based on the carbohydrate content of the dish according to the personalised carbohydrate to insulin ratio.
15994911|NCT02928016|Other|Mixed meal 2|20 adults with type 1 diabetes (T1DM) on intensive insulin treatment consumed grilled chicken with vegetables.The meal provided 399 kcal and contained approximately 300 kcal from protein and fat. Insulin requirements for the test meal were calculated based on the carbohydrate content of the dish according to the personalised carbohydrate to insulin ratio.
15994912|NCT02928016|Other|Mixed meal 3|20 adults with type 1 diabetes (T1DM) on intensive insulin treatment consumed baked giant beans and 20g kalamata olives. The meal provided 502 kcal and contained approximately 300 kcal from protein and fat. Insulin requirements for the test meal were calculated based on the carbohydrate content of the dish according to the personalised carbohydrate to insulin ratio.
15994913|NCT02928016|Other|Mixed meal 4|20 adults with type 1 diabetes (T1DM) on intensive insulin treatment consumed a dish made with thick pasta, minced meat and béchamel sauce and 20 g kalamata olives and 11 ml extra virgin olive oil. The meal provided 893 kcal and contained approximately 600 kcal from protein and fat. Insulin requirements for the test meal were calculated based on the carbohydrate content of the dish according to the personalised carbohydrate to insulin ratio.
15994914|NCT02928016|Other|Mixed meal 5|20 adults with type 1 diabetes (T1DM) on intensive insulin treatment consumed grilled chicken with vegetables and 11 ml extra virgin olive oil. The meal provided 497 kcal and contained approximately 300 kcal from protein and fat. Insulin requirements for the test meal were calculated based on the carbohydrate content of the dish according to the personalised carbohydrate to insulin ratio.
15994915|NCT02928016|Other|Mixed meal 6|20 adults with type 1 diabetes (T1DM) on intensive insulin treatment consumed baked giant beans and 20 g kalamata olives and 11 ml extra virgin olive oil. The meal provided 601 kcal and contained approximately 400 kcal from protein and fat. Insulin requirements for the test meal were calculated based on the carbohydrate content of the dish according to the personalised carbohydrate to insulin ratio.
15994916|NCT02928003|Procedure|Lung surgery|Genetic analysis and questionnaires
15994917|NCT02927990|Other|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention according to standard of care
15994918|NCT02927977|Other|control|Individuals with neck pain will receive a multimodal rehabilitation program composed by pain education, exercises and manual therapy. Participants will receive 4-6 treatments during 4 weeks.
15994919|NCT02927977|Other|dry needling|Individuals with neck pain will receive a multimodal rehabilitation program composed by pain education, exercises, manual therapy and dry needling in neck muscles. Participants will receive 4-6 treatments during 4 weeks.
15994920|NCT02927964|Drug|Ibrutinib|Given PO
15994921|NCT02927964|Radiation|Radiation Therapy|Undergo radiation therapy
15994922|NCT02927964|Drug|TLR9 Agonist SD-101|Given IT
15994923|NCT02927951|Drug|Pregabalin|150mg bid
15994924|NCT02927951|Drug|Placebo|150mg bid
15994925|NCT02927938|Procedure|Allogeneic HCT|Allogeneic HCT
15994926|NCT02927938|Drug|Consolidation chemotherapy|Cytarabine-based consolidation chemotherapy
15994927|NCT02927925|Drug|Daratumumab|Participants will receive daratumumab 16 mg/kg as intravenous infusion.
15994928|NCT02927912|Radiation|Electron Beam Therapy|Undergo IOERT boost
15994929|NCT02927912|Procedure|Lumpectomy|Undergo lumpectomy
15994930|NCT02927912|Other|Quality-of-Life Assessment|Ancillary studies
15994931|NCT02927912|Other|Questionnaire Administration|Ancillary studies
15994932|NCT02927912|Radiation|Radiation Therapy|Undergo whole breast radiation therapy
15994933|NCT02927912|Procedure|Reconstructive Surgery|Undergo oncoplastic reconstruction
15994934|NCT02927899|Other|Survey Administration|Ancillary studies
15994935|NCT02927899|Dietary Supplement|Tomato-Soy Juice|Receive tomato-soy beverages with or without varying levels of arugula seed powder
15994936|NCT02927886|Procedure|Per-oral endoscopy pyloromyotomy|
15994937|NCT02927886|Procedure|Intrapyloric injection of Botulinum toxin|
15994944|NCT02927860|Other|Fitbit|A FitBit HR monitor will be placed on patients when they arrive on the nursing unit after thoracic surgery. Sleep and activity will be monitored for the duration of the patient's hospitalization and the data from the Fitbit HR device will be downloaded by the study staff to a computer.
15994945|NCT02927847|Drug|Nicotine Patch|Both groups will receive nicotine patches (21 mg/d) to wear for 1 month prior to the quit date. After the quit date, both groups will wear the nicotine patch for 8 weeks (21 mg/d for 4 weeks, 14 mg/d for 2 weeks, and 7 mg/d for 2 weeks).
15994946|NCT02927847|Drug|SPECTRUM Nicotine Research Cigarettes (.03 mg)|For 1 month prior to their quit date, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.
15995414|NCT02924441|Other|Calming Music|Played during mammography
15994947|NCT02927847|Behavioral|Behavioral Activation|Participants in the BA+VLNC group will undergo 8 60-minute behavioral sessions (4 pre-quit, 1 on quit day, and 3 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of behavioral activation treatment. BA components will include activity monitoring, values assessment, activity scheduling, and social contracts.
15994948|NCT02927847|Behavioral|Supportive Counseling|Participants in the VLNC Only group will undergo 8 60-minute behavioral sessions (4 pre-quit, 1 on quit day, and 3 post-quit) including 15 min of standard smoking cessation counseling and 45 minutes of supportive counseling and health education. Supportive counseling and health education will include empathic listening as well as informational content on topics of exercise, nutrition, sleep and relaxation.
15994949|NCT02927834|Drug|6 day Prednisone|6 day prednisone burst
15994950|NCT02927834|Drug|Augmentin|Antibiotic augmentin for 3 weeks
15994951|NCT02927834|Drug|21 day Prednisone|21 day prednisone burst
15994952|NCT02927821|Behavioral|ADS Plus|Contact occurs at a minimum for about 1 hour per month over 12 months (face-to-face/ telephone). Targeted education materials concerning clients' conditions and related matters are shared via email or traditional mail. The goal of each contact is to provide ongoing emotional support, situational counseling, education about importance of taking care of self, referrals/linkages and skills (e.g., stress reduction, behavioral management, how to talk with doctors). The care planning process is collaborative and flexible, reflecting CG fluctuating needs
15994953|NCT02927808|Behavioral|Motivational Interview|Informational leaflet about the risks of high LDL-C and the importance of adherence to lipid-lowering medication in patients with coronary artery disease. Follow-up motivational interviewing at 1 and 6 months after discharge.
15994954|NCT02927782|Procedure|Early Mobilization|early postoperative mobilisation (walking and sitting). Initial postoperative mobilisation is going to be under supervision of a qualified physiotherapist. The presence of a qualified physiotherapist at first mobilisation is solely for reasons of safety. No specific exercise or regimen is planned.
15994955|NCT02927782|Procedure|Bed Rest|48 hours of strict bed rest followed by postoperative mobilisation under supervision of a qualified physiotherapist. During the bed rest period elevation of the head is tolerated to a maximum of 30°.
15994956|NCT02927769|Biological|Nivolumab|Specified Dose on Specified Days
15994957|NCT02927769|Biological|brentuximab vedotin|Specified Dose on Specified Days
15994958|NCT02927769|Biological|bendamustine|Specified Dose on Specified Days
15994959|NCT02927743|Behavioral|evidence-based online feedback|GPs received during three months weekly mails about evidence-based practice and a small questionnaire to reflect about their practice and the new knowledge
15994960|NCT02927730|Other|no interventions|no interventions
15994961|NCT02927704|Other|Gingival crevicular fluid (GCF) sample|Single intervention has been performed for each subject. GCF samples were collected from four multi rooted teeth (premolar/molar) one of in each quadrant including two maxilla and two mandibula by single examiner in conjunction with clinical measurements in this intervention.
15994962|NCT02927691|Device|EMST|
15994963|NCT02927691|Behavioral|smTAP|
15994964|NCT02927678|Other|white blood cell SPECT/CT (Single Photon Emission Computed Tomography/Computed Tomography) imaging|
15994965|NCT02927665|Device|Reshape Integrated Dual Balloon|
15994966|NCT02927652|Other|Questionnaires|"New patients at the Duke Clinic 1F and Duke Raleigh Otolaryngology will be asked to complete the Brief Symptom Inventory-18 (BSI-18), patient control scale, and CG-CAHPS.
~If a patients answers a 1, 2, 3, or 4 to question #17 (Thoughts of ending your life) on the BSI-18, the nurse will immediately contact the investigator, who will refer for further assessment and/or treatment. The Duke Social Work office is available to provide support, and the Duke Emergency Department has certified social workers and a psychiatric team to do full evaluations if needed."
15994967|NCT02927639|Other|MyDiaText|The intervention will consist of daily text messages sent to the subject's personal mobile device.
15994968|NCT02927626|Drug|Yang Yin Fu Zheng therapy|Yang Yin Fu Zheng is a Chinese herbal compound.
15994969|NCT02927626|Drug|Routine medical care|Routine medical care
15994970|NCT02927600|Other|Low GI Breakfast|Intake of low GI breakfast
15994971|NCT02927600|Other|High GI Breakfast|Intake of high GI breakfast
15994972|NCT02927600|Other|Low GI Dinner|Intake of Low GI dinner
15994973|NCT02927600|Other|High GI Dinner|Intake of high GI dinner
15994974|NCT02927587|Drug|The induction Cet of propofol|The induction Cet of propofol was targeted respectively at 1 and 2 ug/ml.
15994975|NCT02927574|Device|DCB|
15994976|NCT02927574|Device|POBA|
15994977|NCT02927561|Other|Diabetic Retinopathy screening|Diabetic Retinopathy screening
15994978|NCT02927535|Drug|TNF blockers monotherapy|
15994979|NCT02927522|Drug|Donepezil|Donepezil a cholinesterase inhibitor, 5mg(1 pill)/ day for 7 days Po, was administrated from the day before surgery.
15994980|NCT02927522|Drug|Placebo|Placebo, 1 pill/ day for 7 days Po, was administrated from the day before surgery.
15994981|NCT02927509|Drug|TNF alpha blockers|
15994982|NCT02927496|Drug|Doxycycline|"Once daily tablet for 6 weeks:
~Active comparator: Doxycycline hyclate 200 mg per day x 6 weeks for patients >50 kg or 100 mg per day for patients <50 kg)"
15994983|NCT02927496|Drug|Placebo|Once daily tablet for 6 weeks. Placebo comparator: matching tablets containing no active ingredients
15994984|NCT02927483|Dietary Supplement|Endolex Forte®|Endolex Forte® oral capsules administered from Baseline Visit until Day 180, two capsules per day.
15994985|NCT02927483|Dietary Supplement|A combination of diosmin and hesperidin|A combination of diosmin and hesperidin is a combination of micronized diosmin (450 mg) and micronized hesperidin (50 mg) film-coated tablets administered from Baseline Visit until Day 180, two tablets per day.
15994986|NCT02927470|Device|Sham TMS condition|A sham TMS coil will be used to measure baseline performance on the working memory task. The sham coil looks and sounds just like the real coil, but produces a negligible magnetic field. Following the 40 seconds of sham TBS, the subject will perform the working memory task for 45 minutes.
15995028|NCT02927197|Behavioral|LearningRx cognitive training|A clinician will deliver forty 90-minute cognitive training sessions over 12-14 weeks for a total of 60 training hours. There are 23 different categories of training procedures sequenced in intensity and difficulty for a total of more than 1000 training tasks.
15995029|NCT02927184|Drug|VK2809|
15994987|NCT02927470|Device|OffLine TMS Condition|A total of 200 trains will be delivered successively in 40 s, totaling 600 pulses. The pulses will be delivered at 80% of motor thresholds. A sham TMS coil will be used to measure baseline performance on the working memory task. The sham coil looks and sounds just like the real coil, but produces a negligible magnetic field. Following the 40 seconds of TBS, or sham TBS, the subject will perform the working memory task for 45 minutes.
15994988|NCT02927470|Device|Online TMS condition|A single train of pulses (3 pulses at 50Hz, duration 40ms) will be delivered once during a particular time epoch on each trial, followed by a minimum of 6 seconds of no stimulation. No more than 600 pulses will be applied in a single session. Similar to the offline TMS condition, a sham TMS coil will be used to measure baseline performance on the working memory task. In each session (frontal, sham) subjects will perform the working memory task for 45 minutes.
15994989|NCT02927457|Drug|GSK2646264 1%|A cream for topical application with a concentration of 1% GSK2646264.
15994990|NCT02927457|Drug|Placebo|Subjects will receive matching Placebo topically.
15994991|NCT02927444|Biological|NBP606|A single intramuscular injection into the thigh
15994992|NCT02927444|Biological|Prevnar13|A single intramuscular injection into the thigh
15994993|NCT02927431|Drug|Danirixin 15 mg FBE|This intervention is available as a 50 mg FBE sterile lyophilized powder containing DNX (hydrobromide salt hemihydrate) equivalent to 50mg of free base along with Beta-cyclodextrin sulfobutylether, mannitol, citric acid and sodium hydroxide. The formulation is supplied as lyophilized powder/cake contained in a 30mL vial. Each vial is reconstituted with 9.5 mL water for injection and further diluted with saline for IV infusion to provide a dose of 15 mg FBE.
15994994|NCT02927431|Drug|Danirixin 50 mg FBE|This intervention is available as a 50 mg FBE sterile lyophilized powder containing DNX (hydrobromide salt hemihydrate) equivalent to 50mg of free base along with Beta-cyclodextrin sulfobutylether, mannitol, citric acid and sodium hydroxide. The formulation is supplied as lyophilized powder/cake contained in a 30mL vial. Each vial is reconstituted with 9.5 mL water for injection and further diluted with saline for IV infusion.
15994995|NCT02927431|Drug|Placebo|No vials of placebo to match IV DNX will be provided. A normal saline solution of matched volume will be prepared by unblinded personnel at the site to act as a placebo to DNX. Clear solution of placebo will be administered as IV infusion.
15994996|NCT02927431|Drug|Oseltamivir 75 mg|Oseltamivir (Tamiflu - manufactured by Roche) formulation is available as 75 mg Capsule and as powder for oral suspension. After constitution with 55 mL of water, each bottle delivers a usable volume of 60 mL of oral suspension equivalent to 360 mg oseltamivir base (6 mg/mL). No oseltamivir capsules or powder for oral suspension will be provided. Sites will source the OSV locally and it will be provided open-label.
15994997|NCT02927418|Behavioral|Strength & Conditioning|
15994998|NCT02927418|Behavioral|Control|
15994999|NCT02927405|Drug|Gabapentin|anticonvulsant drug that is used for neuropathic pain.
15995000|NCT02927405|Procedure|TAP Block|a procedure done anesthetize the anterior abdominal wall
15995001|NCT02927392|Drug|Leuprolide acetate|A subset of premenopausal women will receive GnRHAG (leuprolide acetate) 3.75 mg/mo by intramuscular injection every 4 weeks for 24 weeks (6 doses).
15995002|NCT02927379|Drug|Dexmedetomidine|local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline plus dexmetedomidine in two divided doses i.e. 20 ml is administered on each side of incision
15995003|NCT02927379|Drug|Ketamine|local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline plus ketamine in two divided doses i.e. 20 ml is administered on each side of incision
15995004|NCT02927379|Drug|Bupivacaine|local anesthetic wound infiltration with with 20 ml of bupivacaine 0.5 % diluted in 20 ml saline only in two divided doses i.e. 20 ml is administered on each side of incision
15995005|NCT02927366|Drug|QCC374|0.03 mg (2 capsules of 0.015 mg) BID 0.06 mg (1 capsule of 0.06 mg) BID 0.12 mg (2 capsules of 0.06 mg) BID
15995006|NCT02927366|Drug|Placebo Matching|"Placebo matching to QCC374:
~0.03 mg BID, 0.06 mg BID and 0.12 mg BID"
15995007|NCT02927353|Drug|DMB-3113|subcutaneously injected in a single dose of 40 mg.
15995008|NCT02927353|Drug|Adalimumab|subcutaneously injected in a single dose of 40 mg.
15995009|NCT02927340|Drug|Lorlatinib|
15995010|NCT02927327|Device|Zero Echo Time (ZTE) scan for head attenuation|"The GE SIGNA PET/MR MP26 software platform includes the zero echo time (ZTE) scan for head attenuation and Q.Static. The ZTE MR software feature has the potential to enable better visualization of bones, including those in the head, by employing optimal head attenuation correction in PET/MR.
~PET/MR ZTE MRAC"
15995011|NCT02927327|Device|Q.Static (Q. MRAC) for respiratory motion correction|"An improved Q.Static feature with Q. MRAC, where phase matching the MRAC with the quiescent phase is employed to get more accurate attenuation correction for our Q.Static PET images.
~PET/MR Q Static (Q. MRAC)"
15995012|NCT02927314|Drug|CF102|orally q12h
15995013|NCT02927314|Drug|Placebo|orally q12h
15995014|NCT02927301|Drug|Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody|Atezolizumab was given as 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of each 21-day cycle.
15995015|NCT02927275|Behavioral|Experimental: Standing Modality|Cognitive performance when standing
15995016|NCT02927275|Behavioral|Experimental: Biking Modality|Cognitive performance when biking slowly
15995017|NCT02927275|Behavioral|Experimental: Walking Modality|Cognitive performance when walking at 1mph
15995018|NCT02927275|Behavioral|No Intervention: Seated Modality|Cognitive performance when sitting.
15995019|NCT02927262|Drug|gilteritinib|Tablet to be taken orally once daily.
15995020|NCT02927262|Drug|Placebo|Matching placebo tablet to be taken orally once daily.
15995021|NCT02927249|Other|Placebo|Given PO
15995022|NCT02927249|Drug|Aspirin|Given PO
15995023|NCT02927236|Device|TMS|TBS is a type of TMS protocol.To administer the iTBS treatment, a MagVenture MagPro 100 with MagOption (MagVenture Inc, Alpharetta, GA) machine equipped with a figure-8 coil will be used.
15995024|NCT02927223|Drug|Atropine|
15995025|NCT02927223|Procedure|Exercise treadmill test|
15995026|NCT02927210|Drug|Dimethandrolone Undecanoate|Single doses of DMAU in castor oil/benzyl benzoate injections intramuscularly (IM) (80 mg, 240 mg, 480 mg, and 800 mg) or administered subcutaneously (SC) (50 mg, 100 mg and 200 mg).
15995027|NCT02927210|Drug|Placebo|Placebo injections that look like the DMAU injections but with no active ingredients
15995031|NCT02927171|Other|IntenSive Therapeutic Rehabilitation for Older Skilled Nursing Home Residents|Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities.
15995032|NCT02927145|Biological|RH5.1/ ASO1|"The RH5.1 protein consists of the entire full-length ectodomain of the PfRH5 antigen (amino acids E26 - Q526) with the sequence based on the 3D7 clone of P. falciparum.
~The AS01 adjuvant system has been developed and manufactured by GlaxoSmithKline (GSK) Biologicals and is presented as a liquid solution in a monodose glass vial. AS01 is a liposome-based Adjuvant System with a specific aim to improve cell-mediated immunity."
15995033|NCT02927132|Behavioral|Expressive Writing|Expressive writing is a brief intervention that has been linked to various health and social benefits. Expressing emotions through writing can lead to decreased levels of stress and negative affect, thereby serving as a coping mechanism. Furthermore, expressive writing allows participants to reconstruct their traumatic experiences and reorganize their memory of these events into a narrative. Expressive writing has been used to target drinking. Research has found that students have reduced drinking intentions after writing about a negative drinking event compared to control,suggesting that a narrative intervention may be effective in reducing drinking. Other research suggests that feelings of guilt were more strongly associated with intentions to reduce drinking after writing about a negative drinking event, and that this event-related guilt mediated intervention effects.
15995034|NCT02927132|Behavioral|Personalized Normative Feedback|"PNF approaches use information designed to correct normative misperceptions to reduce heavy drinking. Three pieces of information are necessary when providing personalized normative feedback: information about a student's own drinking, information about the student's perceptions of others' drinking, and information about others' actual drinking. The presentation of this information is designed to change students' perceptions of normal drinking by exposing their misperceptions of the norm as well as by comparing their behavior with normal behavior."
15995035|NCT02927119|Dietary Supplement|iodine|≥ 150 µg/day iodine supplementation (iodine containing pregnancy supplement) prior to enrollment
15995036|NCT02927080|Drug|ACE-083|Recombinant fusion protein.
15995037|NCT02927080|Drug|ACE-083 or placebo|Recombinant fusion protein or normal saline.
15995038|NCT02927067|Drug|Maribavir|Participants will receive 400 mg of maribavir BID orally.
15995039|NCT02927067|Drug|Valganciclovir|Participants will receive valganciclovir tablets orally.
15995040|NCT02927067|Other|Placebo|Participants will receive placebo tablets matched to either maribavir or valganciclovir.
15995041|NCT02927054|Other|Sepsis Education|Education provided to hospital residents for the recognition and treatment of systemic inflammatory response syndrome (SIRS), sepsis and severe sepsis
15995042|NCT02927041|Device|transesophageal echocardiography (hTEE)|Hemodynamic interventions include volume resuscitation, vasopressors and positive inotropes. Anesthesiologist may or may not use the information provided by the transesophageal echocardiography.
15995043|NCT02927028|Other|Chewing|"On the first visit, the random nut treatments will include chewing walnuts, almonds and pistachios. The chewing conditions will include: 1) 5 g nuts alone, 2) 5 g nuts with 5 ml water, 3) 5 g nuts with 5 ml apple juice, 4) 5 g nuts with 5 g plain yogurt, 5) 5 g nuts with 5 g sweet yogurt.
~On visits 2 and 3 the treatments of either 28 g of walnuts or walnut butter will be presented."
15995044|NCT02927015|Other|Purple Majesty potato chips|Purple Majesty potato chips
15995045|NCT02927015|Other|Mountain Rose potato chips|Mountain Rose potato chips
15995046|NCT02927015|Other|White potato chips|White potato chips
15995047|NCT02927015|Other|Crackers|Crackers
15995048|NCT02927002|Device|Noninvasive brain stimulation|
15995049|NCT02926989|Drug|Plasmalyte Glucos 50 mg/mL|Solution contains potassium chloride 5 mmol/L and sodium chloride 140 mmol/L.
15995050|NCT02926989|Drug|0.45% saline in 5% dextrose|Solution contains potassium chloride 20 mmol/L and sodium chloride 80 mmol/L.
15995051|NCT02926976|Drug|Risperidone with Clozapine|Risperidone may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia
15995052|NCT02926976|Drug|Aripiprazole with Clozapine|Aripiprazole may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia
15995053|NCT02926976|Drug|sodium valproate with Clozapine|sodium valproate may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia
15995054|NCT02926976|Device|modified electroconvulsive therapy(MECT) with Clozapine|modified electroconvulsive therapy(MECT) may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia
15995055|NCT02926976|Device|Magnetic seizure therapy(MST) with Clozapine|Magnetic seizure therapy(MST) may be used as a synergistic agent of clozapine in the treatment of treatment-resistant schizophrenia
15995056|NCT02926976|Device|clozapine|clozapine may be used in the treatment of treatment-resistant schizophrenia
15995057|NCT02926963|Other|samples collection : hair and skin biopsy|
15995058|NCT02926950|Drug|Sotagliflozin (SAR439954)|Pharmaceutical form: tablet. Route of administration: oral.
15995059|NCT02926950|Drug|Placebo|Pharmaceutical form: tablet. Route of administration: oral.
15995060|NCT02926950|Drug|Metformin|Pharmaceutical form: tablet. Route of administration: oral.
15995061|NCT02926937|Drug|Sotagliflozin (SAR439954)|"Pharmaceutical form: tablet;
~Route of administration: oral"
15995062|NCT02926937|Drug|Placebo|"Pharmaceutical form: tablet;
~Route of administration: oral"
15995063|NCT02926924|Device|Wound Vac|a therapeutic technique using a vacuum dressing to promote healing in acute or chronic wounds and enhance healing of first and second degree burns.
15995064|NCT02926924|Other|Standard Dressing|standard dressing with drain tube and bandage
15995065|NCT02926911|Other|Surgery|Surgery +/- radiation choice for endocrine therapy
15995066|NCT02926911|Other|Active Monitoring|Choice for endocrine therapy
15995067|NCT02926898|Drug|ZX008 - 0.2 mg/kg/day|ZX008 - 0.2 mg/kg/day ZX008 drug product is an oral aqueous solution of fenfluramine hydrochloride buffered to pH 5 and provided in concentrations of 1.25 mg/mL, 2.5 mg/ mL, and 5 mg/mL. The product is sugar free and is intended to be compatible with KD.
15995068|NCT02926898|Drug|ZX008 - 0.4 mg/kg/day|ZX008 - 0.4 mg/kg/day ZX008 drug product is an oral aqueous solution of fenfluramine hydrochloride buffered to pH 5 and provided in concentrations of 1.25 mg/mL, 2.5 mg/ mL, and 5 mg/mL. The product is sugar free and is intended to be compatible with KD.
16032152|NCT02651246|Other|data collection|
15995069|NCT02926898|Drug|ZX008 - 20 mg/day maximum dose|ZX008 - 20 mg/day maximum dose ZX008 drug product is an oral aqueous solution of fenfluramine hydrochloride buffered to pH 5 and
15995070|NCT02926898|Drug|Matching Placebo|ZX008 Matching Placebo
15995071|NCT02926885|Device|CONVENTIONAL LIVER RETRACTOR DEVICE|LIVER RETRACTION FOR THE EXPOSURE OF THE ESOPHAGOGASTRIC JUNCTION USING CONVENTIONAL RETRACTOR DEVICE
15995072|NCT02926885|Device|FLEXIBLE LIVER RETRACTOR DEVICE|LIVER RETRACTION FOR THE EXPOSURE OF THE ESOPHAGOGASTRIC JUNCTION USING FLEXIBLE LIVER RETRACTOR DEVICE
15995073|NCT02926885|Procedure|LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY|LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY
15995074|NCT02926872|Other|There is no intervention in the study|
15995075|NCT02926859|Drug|Cannabidiol as add-on|Cannabidiol capsules 2x200 mg twice a day as add-on to individualized pharmacological treatment with either amisulpride, aripiprazole, olanzapine, quetiapine or risperidone over 26 weeks
15995076|NCT02926859|Drug|Placebo as add-on|Placebo capsules 2x200 mg twice a day as add-on to individualized pharmacological treatment with either amisulpride, aripiprazole, olanzapine, quetiapine or risperidone over 26 weeks
15995077|NCT02926846|Drug|Intravenous vancomycin & gentamicin with adjunctive lavage|"Intravenous vancomycin and gentamicin are administered, together with adjunctive lavage performed by automated peritoneal dialysis machine over 48 to 72 hours.
~(choice of antibiotic is adjusted in accordance with the microbiology report when available)"
15995078|NCT02926846|Drug|Intraperitoneal vancomycin & gentamicin|"Intraperitoneal vancomycin and gentamicin are administered, with the usual continuous ambulatory peritoneal dialysis schedule maintained.
~(choice of antibiotic is adjusted in accordance with the microbiology report when available)"
15995079|NCT02926833|Biological|KTE-C19|A single infusion of KTE-C19 CAR-T cells administered intravenously
15995080|NCT02926833|Biological|Atezolizumab|Administered intravenously
15995081|NCT02926833|Drug|Cyclophosphamide|Administered intravenously
15995082|NCT02926833|Drug|Fludarabine|Administered intravenously
15995083|NCT02926820|Behavioral|Cogmed QM|The intervention consisted of 25 Cogmed sessions, typically completed over a five week period (i.e. 5 days per week), with each session lasting between 40-50 minutes per day. The program consists of 12 exercises that target visuo-spatial or verbal working memory. At each training session, participants completed 8 of the 12 exercises (order selected by the user), with 15 trials per exercise. Cogmed QM is an adaptive program, wherein task difficulty is adjusted to performance on each trial. The level of difficulty adjusts continuously and automatically, ensuring that each session provides an engaging, challenging level of WM capacity. Breaks were permitted, and encouraged, at the participants' discretion throughout the session.
15995084|NCT02926807|Other|FDG-PET Scan|a 18FDG-PET to quantify vascular inflammation
15995085|NCT02926807|Other|MDCT|a MDCT to calculate the Agatston score
15995086|NCT02926807|Other|biopsy and blood collection|biopsy and blood collection to assess biomarkers
15995087|NCT02926794|Behavioral|SA and II|Self affirmation intervention where participants rank 11 values, then write about why their top ranked value is important AND Implementation intentions intervention where participants form two implementation intentions (If/then) statements regarding drinking behavior and write why these are important
15995088|NCT02926794|Behavioral|SA and No II|Self affirmation intervention where participants rank 11 values, then write about why their top ranked value is important AND No implementation intentions intervention where participants write why selected health strategies are important (and do nothing else)
15995089|NCT02926794|Behavioral|No SA and II|Control writing intervention where participants rank 11 values, then write about why their 10th ranked value is important to someone else AND Implementation intentions intervention where participants form two implementation intentions (If/then) statements regarding drinking behavior and write why these are important
15995090|NCT02926794|Behavioral|No SA and No II|Control writing intervention where participants rank 11 values, then write about why their 10th ranked value is important to someone else AND No implementation intentions intervention where participants write why selected health strategies are important (and do nothing else)
15995091|NCT02926781|Device|Dask Advanced Sinus kit|a kit of specially designed drills for closed sinus lift
15995092|NCT02926768|Drug|CK-101|"Phase 1: CK-101 will be administered in escalating dosages in a period of 21-day cycles
~Phase 2: CK-101 will be administered daily"
15995093|NCT02926755|Procedure|Coronary Angiography|Coronary angiography which includes fractional flow reserve (FFR),that allows precise measurement of blood flow in the arteries to the heart; the Near Infra-Red Spectroscopy-Intravascular Ultrasound (NIRS IVUS) provides information about the amount of lipid and cholesterol in the plaque, and plaque volume;the Optical Coherence Tomography (OCT) allows physicians to assess tears in the surface of plaque and plaque thickness; and Coronary CT Angiography (CCTA) to evaluate plaque characteristics, and correlate with the invasive findings. The research portion of the study requires all imaging studies be performed (NIRS, IVUS, OCT, FFR) during coronary angiography, rather than just one or two of these imaging studies, and the CCTA.
15995094|NCT02926742|Device|EkoSonic Endovascular System|Ultrasound catheter-directed thrombolysis.
15995095|NCT02926729|Device|nonlinear microscopy imaging of excised surgical margins|Following standard lumpectomy excision, excised tissue will be imaged with NLM. If invasive cancer or ductal carcinoma in situ (DCIS) is detected on or close to the margin, additional excision may be performed. Following surgery, final margins will be evaluated using paraffin embedded histopathology as per standard procedure. Paraffin embedded histopathology will be used to make a final margin determination.
15995096|NCT02926729|Procedure|standard lumpectomy without nonlinear microscopy imaging|Lumpectomy with postoperative paraffin embedded histopathology to make a final margin determination.
15995097|NCT02926703|Other|Serum lactate and CK concentrations in blood samples|Serum lactate and CK concentrations in blood samples were measured routinely at admission
15995098|NCT02926690|Drug|OTS167PO|Single arm, no competitor
15995099|NCT02926677|Behavioral|Cue-Centered Treatment (CCT)|Identify stress reactions and develop coping skills to deal with them independently. Helps address ongoing traumatic stressors.
15995100|NCT02926677|Behavioral|Trauma-Focused CBT (TF-CBT)|Identifies negative cognitive/emotional patterns and helps re-frame them. Uses active support from guardians and focuses on emotional and cognitive conditioning. Focuses on discrete past incidents.
15995101|NCT02926677|Behavioral|Treatment as Usual|The control group. The standard treatment utilized at Stanford Youth Solutions
15995102|NCT02926677|Device|NIRScout|The device is a portable Functional Near-Infrared Spectroscopy (fNIRS) recording unit. NIRS technology uses specific wavelengths of light, introduced at the scalp to enable the non-invasive measurement of changes in the relative ratios of deoxygenated hemoglobin (deoxy-Hb) and oxygenated hemoglobin (oxy-Hb) in the capillary beds during brain activity.
15995103|NCT02926664|Other|measurement of qSOFA|qSOFA will be measured at H0, H1 and H3
15995106|NCT02926638|Drug|Erlotinib Hydrochloride|Given PO
15995107|NCT02926638|Other|Laboratory Biomarker Analysis|Correlative studies
15995108|NCT02926638|Biological|Rilotumumab|Given IV
15995109|NCT02926625|Behavioral|Systematic follow-up|"Febrile children without a diagnosable illness and without danger signs do not need to return to the HEW unless they are still sick, as over 90% of fevers resolve by themselves.
~HEW advice and procedures
~Children with unclassified fever should come back for re-assessment after 2 days only if the child still has fever or is sick
~Children who are getting worse should come back immediately or at any time for a re-assessment
~All children who come back for re-assessment, regardless of when they come back, should have a full assessment of their condition again.
~HEW should fill out a loose child assessment form
~If child still has fever and a negative rapid diagnostic test for malaria (mRDT), the HEW should refer the child to the nearest health centre."
15995110|NCT02926625|Behavioral|Conditional follow-up|Health extension workers will be trained to counsel caregivers of children with unclassified fever that they should have a conditional follow-up visit, i.e. only to come back for re-assessment after 2 days if the child still has fever or is sick. This is in line with national IMNCI guidelines.
15995111|NCT02926612|Other|Next Generation Genomic Sequencing|DNA and RNA are extracted from biospecimens, amplified, sequenced, and then compared to known microbe databases, allowing for quantitative identification of non-host organisms
15995112|NCT02926599|Behavioral|Personal Optimization Training|
15995113|NCT02926586|Drug|Fludarabine|Fludarabine 50 mg/m2, IV (in the vein) in combination with cytarabine 1500mg/m2/d for 5 days with each cycle of 28 days. Number of cycles: 4
15995114|NCT02926586|Drug|Cytarabine|2000mg/m2/12h, IV (in the vein) for 3 days with each cycle of 28 days. Number of cycles: 4
15995115|NCT02926573|Drug|Gabapentin|
15995116|NCT02926573|Drug|Placebo|
15995117|NCT02926521|Device|2-octyl cyanoacrylate|Addition of 2-octyl cyanoacrylate liquid adhesive to nerve catheter dressing
15995118|NCT02926521|Device|Gum Mastic|Addition of gum mastic liquid adhesive to nerve catheter dressing
15995119|NCT02926508|Dietary Supplement|Bimuno (BGOS)|"The active supplement of the food supplement (Bimuno) used in this study is called galacto-oliogosaccharides (Bimuno®, BGOS). BGOS is a compound metabolised by specific bifidobacteria, which are beneficial bacteria, in our colon. Bimuno (2.3 calories) is composed by the following ingredients per gram of Bimuno: 0.96g dry matter; <01g Fat; <0.06g Protein; 0.821g GOS; 0.119g Lactose; 0.0331g Glucose and 0.0029g Galactose. Bimuno is tasteless.
~Bimuno will be supplied in coded sachets (3.5g) for dispensing by parents. Each participant will be required to consume 1 sachet daily during breakfast, by mixing it with food or in a drink."
15995120|NCT02926508|Other|Maltodextrin|"Maltodextrin is a polysaccharide in powder form, which grows most bacteria in the gut, and not specifically the beneficial bifidobacteria.
~The placebo will also be provided in daily coded sachets (3.5g) for dispensing by parents. Each participant will be required to consume 1 sachet daily during breakfast, by mixing it with food or in a drink.
~This placebo has been used in previous studies, in which Bimuno was used as the active intervention. The placebo will be similar in taste and colour to the active intervention."
15995121|NCT02926495|Device|eCoin System|Median nerve neurostimulator.
15995122|NCT02926482|Behavioral|Prescriber Recruitment Bundle (PRB)|The Prescriber Recruitment Bundle (PRB) is a bundle pharmacotherapy capacity building practices. The PRB to be implemented contains the following elements, a) candidate identification strategies, b) prescriber education forums, c) prescriber-friendly workflow and risk-reduction strategies, d) academic detailing to recruit OUD prescribers, e) telemedicine, and f) organizational leadership and culture to support building OUD pharmacotherapy capacity.
15995123|NCT02926469|Device|Virtual Reality|Using Virtual Reality during labor
15995124|NCT02926443|Other|Upper Extremity Neuromuscular Training Program|Neuromuscular and strengthening shoulder exercises in a group setting.
15995125|NCT02926443|Other|Usual Physiotherapy Care|One-on-one physiotherapy care in a clinical setting.
15995126|NCT02926430|Biological|Ad26.RSV.preF 5*10^10 vp|Ad26.RSV.preF will be given at a concentration of 5*10^10 vp/0.5 milliliter (mL).
15995127|NCT02926430|Biological|Ad26.RSV.preF 1*10^11 vp|Ad26.RSV.preF will be given at a concentration of 1*10^11 vp/0.5 milliliter (mL).
15995128|NCT02926430|Drug|Placebo|Participants will receive placebo as formulation buffer.
15995129|NCT02926417|Procedure|High Density-Electroencephalogram|
15995130|NCT02926404|Device|UNiD Rods|Spinal osteosynthesis
15995131|NCT02926391|Device|UNiD 3D VBR|Corpectomy of one or several vertebral body(ies) followed by vertebral body(ies) replacement and fusion
15995132|NCT02926378|Procedure|Acupuncture Treatments|Every participant will receive six acupuncture treatments across a three to four-week period. The treatments will last a total of about one hour, including a 10 minute initial assessment, needling, and 45 min of lying down with the needles. Two treatments a week will be performed by Dr. Siminovich-Blok, the PI of this study and a NYS licensed acupuncturist at NYU Langone Medical Center (NYULMC) Ambulatory Care Center. Each acupuncture treatment will consist of 1) a combination of a fixed set of points suggested by the literature, and 2) an individualized set of points based on the evaluation by the licensed acupuncturist. The first set of points will consist of 4 acupoints used consistently in the treatment of stroke through the literature.
15995133|NCT02926365|Behavioral|ICBT|
15995134|NCT02926352|Behavioral|Extinction Training|Up to 40 min. of self-directed repeated exposure to a fear-provoking situation.
15995135|NCT02926352|Device|Low-Level Laser Therapy|1064nm light used to modulate a biological function and induce a therapeutic effect.
15995137|NCT02926339|Behavioral|Teens Against Tobacco Use presentation|Students receive a series of 3 anti-tobacco presentations delivered by older peers
15995138|NCT02926326|Drug|BCT197|A single dose of BCT197
15995139|NCT02926326|Drug|Azithromycin|3 daily doses of Azithromycin
15995140|NCT02926313|Other|Individualized Seating provision|Seating system selected and adjusted to meet individual needs.
15995141|NCT02926300|Biological|stem cells|IV infusion
15995142|NCT02926287|Other|Ambulatory surgery|All patients who accepting participation to the study and operated for prolapse surgery, Patient eligible for Ambulatory surgery and return home on the same day if delivery criteria are satisfied ( Chung criteria+tsuccessful trial of void) Patient not eligible for Ambulatory surgery are included as control group
15995143|NCT02926261|Other|Bioelectrical impedance vector analysis|Evaluation of nutritional status with Bioelectrical impedance vector analysis, hand-grip strength and computed-tomography scan
15995144|NCT02926248|Drug|Colchicine|Colchicine is an anti-fibrotic and anti-inflammatory drug
15995145|NCT02926248|Other|Placebo|
15995146|NCT02926235|Drug|Amino Acid|Treatment arm
15995147|NCT02926235|Other|Placebo|
15995148|NCT02926222|Drug|Regorafenib|Regorafenib is formulated as tablets of 40mg for oral administration.
15995149|NCT02926222|Drug|Lomustine|Lomustine is formulated as tablets of 40mg for oral administration.
15995150|NCT02926209|Device|Aer-O-Scope (Colonoscopy)|"Patients in the Aer-O-Scope first arm will undergo a colonoscopy with the Aer-O-Scope, removing any polyps detected, followed by a colonoscopy using a conventional colonoscope, removing any polyps not previously detected with the Aer-O-Scope."
15995151|NCT02926209|Procedure|Colonoscopy (Conventional Colonoscope)|"Patients in the conventional colonoscope first arm will undergo a colonoscopy with a conventional colonoscope, removing any polyps detected, followed by a colonoscopy using the Aer-O-Scope, removing any polyps not previously detected with the conventional colonoscope"
15995152|NCT02926196|Drug|MSB0010718C|MSB0010718C-Avelumab is formulated as vials of 200 mg strength for IV administration
15995153|NCT02926183|Drug|Neoadjuvant chemotherapy of gemcitabine plus nab-paclitaxel|Enrolled patients were administered a 30-min intravenous infusion of nab-paclitaxel at a dose of 125 mg/m2, followed by a 30-min intravenous infusion of gemcitabine at a dose of 1000 mg/m2, on day 1, 8, and 15 evey 4 weeks as one cycle of regimen.
15995154|NCT02926170|Drug|Rivaroxaban|Rivaroxaban will be started at 20 mg/day. Dose will be adjusted according to Cr Clearance. Cr Clearance 30-49 ml/min will receive 15 mg/day.
15995155|NCT02926170|Drug|acenocumarol|Doses will be adjusted according to INR
15995156|NCT02926157|Behavioral|Life Style and Sleep Intervention|
15995159|NCT02926131|Other|Blood sampling|"One full capillary tube (50µl blood) will be used to measure the Hct level and the routine SBR using the BR-501 bilirubin meter machine (non-study procedure).
~An additional half- filled capillary tube (25µl blood) will be used for the SBR measurement with the Bilistick system"
15995160|NCT02926118|Dietary Supplement|Low glycemic load|Low glycemic load diets will be consumed at breakfast, lunch and dinner for three consecutive days
15995161|NCT02926118|Dietary Supplement|High glycemic load|High glycemic load diets will be consumed at breakfast, lunch and dinner for three consecutive days
15995162|NCT02926105|Behavioral|T&E Home-based exercise programme|"T&E exercises programme consists of home-based individually tailored balance and functional strength tests and exercises performed 3x a week over 12 months, accompanied by eight in-home visits of physiotherapists during the first six months."
15995163|NCT02926105|Behavioral|Otago|Otago exercises programme consists of home-based individually tailored balance, strength and walking exercises performed 3x a week over 12 months, accompanied by eight in-home visits of physiotherapists during the first six months.
15995164|NCT02926105|Behavioral|Helsana booklet|Helsana programme consists of a booklet with recommendations and 10 exercises performed 3x a week over 12 months.
15995165|NCT02926092|Diagnostic Test|Observation|Observation of progression of disease over time
15995166|NCT02926066|Drug|AAV2-hAADC|"Dosage form: Aqueous solution Dose(s): 2.37x10^11 vg/case(High dose) Dosing schedule: Intracerebral infusion, single dose Mechanism of action (if known): supplement a gene defect
~Dosage form: Aqueous solution Dose(s): 1.81x10^11 vg/case(Standard dose) Dosing schedule: Intracerebral infusion, single dose Mechanism of action (if known): supplement a gene defect"
15995167|NCT02926053|Procedure|Surgical removal of tumor tissue for T cell production|Surgical removal of > 1 cm3 tumor tissue chosen with regards to high rate of success and to minimize the general risks involved in a surgical procedure.
15995168|NCT02926053|Drug|Cyclophosphamide|Cyclophosphamide 60 mg/kg is administered i.v. on day -7 and day -6.
15995169|NCT02926053|Drug|Fludarabine|Fludarabine 25 mg/m2 is administered on day -5 to day -1. Maximum dose of 50 mg per administration.
15995170|NCT02926053|Biological|TIL infusion|The maximum number of expanded TILs are infused over 30-45 minutes on day 0.
15995171|NCT02926053|Drug|Interleukin-2|Interleukin-2 is administered as high-dose bolus infusions (600.000 IU/kg) over a 15 minute period every 8 hours and continuing for up to 5 days (maximum of 15 doses).
15995172|NCT02926040|Procedure|Irreversible electroporation|
15995173|NCT02926027|Drug|Vascepa|Vascepa is a an Eicosapentaenoic acid (EPA), an omega-3 polyunsaturated fatty acid.
15995174|NCT02926027|Drug|placebo|placebo
15995175|NCT02926014|Device|Videolaryngoscopy|A rigid 70 degree laryngoscope is inserted into the subject's oropharynx, which allows to visualize the lingual tonsils. The size of the lingual tonsils is evaluated using DelGaudio and Friedman grading systems.
15995204|NCT02925780|Device|Resin infiltration|"Teeth selected for this group will be treated with the resin infiltrant Icon according to the manufacturer's instructions. In short, teeth will be isolated with a rubber dam and the labial tooth surface cleaned with non-fluoride prophylactic paste and pumice. After an etching and drying step (to open the lesion surface), Icon will be applied following the manufacturer's instructions and subsequently light cured, followed by polishing.
~Digital images are taken before and after the treatment as well as at the follow-up visits (3, 6, 9 and 12 months)."
15995415|NCT02924441|Other|No Music|No music played during mammography
15995176|NCT02926014|Other|Reflux Symptom Index Questionnaire|A validated clinical tool for suspecting laryngopharyngeal reflux (LPR). The questionnaire was proposed by Belafsky et al. (2002) and consists of 9 most common gastroesophageal reflux disease (GERD) and LPR symptoms: hoarseness or a problem with your voice; clearing your throat; excess throat mucus or postnasal drip; difficulty swallowing food, liquids, or pills; coughing after you ate or after lying down; breathing difficulties or choking episodes; troublesome or annoying cough; sensation of something sticking in your throat or a lump in your throat; heartburn, chest pain, indigestion, or stomach acid coming up. Each symptom is evaluated on a scale from 0 to 5 (0 - no complaint, 5 - severe symptom). The sum of all symptom evaluations ranges from 0 to 45.
15995177|NCT02926014|Other|Dysphagia Screening Questionnaire|"A validated questionnaire, proposed by Ohkuma et al. (2002). Lithuanian version of the questionnaire consists of 16 questions: choking during swallowing meals / liquids; difficulty eating solid foods; difficult swallowing; feeling of food getting stuck in the throat; longer than before eating time; feeling of food remaining in the mouth; feeling that food or liquid is going up into the throat from the stomach; feeling of food being stuck in the esophagus; weight loss; food getting stuck in the throat; food falling from the mouth; difficulty coughing during or after meals; occurrence of pneumonia; hoarseness; coughing during the night. Interpretation of dysphagia screening questionnaire:
~Advanced symptom - 2 points; Moderate intensity symptom - 1 point; No symptom - 0 point. At least one advanced symptom means - dysphagia. Higher score represents stronger dysphagia intensity. The maximum score is 32 points."
15995178|NCT02925988|Device|EEG monitoring|Neonates will receive their amplitude-integrated EEG monitoring as soon as the indication for monitoring is established, and conventional EEG electrodes will be applied in parallel.
15995179|NCT02925975|Drug|Carvedilol|Carvedilol starts from 6.25mg daily and increase to 12.5mg once daily in next week if being tolerated.
15995180|NCT02925975|Device|3D-vHPS|This 3D model of HPS is rebuilt by a software combining the anatomic information of vessels from CTA (computed tomographic angiography) and the blood stream speed of targeted vessel from Doppler Ultrasound.
15995181|NCT02925975|Procedure|Routine endoscopic procedures|These include esophageal band ligation and tissue glue injection in the fundus of stomach by upper GI endoscopy if there are visible varies in cirrhotic patients. There routine procedures are done to prevent potential varies associated bleeding.
15995182|NCT02925962|Other|Clinical Decision Support System (CDSS)|A targeted, automated CKD clinical decision support system (CDSS) designed to improve bloodpressure (BP) level, disease awareness, staging, processes of care, and knowledge among persons with documented reduced eGFRcreat (creatinine-based estimated glomerular filtration rate) in primary care setting.
15995183|NCT02925962|Other|Clinic Decision Sup System + Pharmacist|Includes everything in the CDSS intervention but adds a follow-up call from a pharmacist, who is part of the clinical team. The rationale for this third arm is based on the evidence that clinical pharmacists have been shown to be more effective than physicians alone at achieving BP control in other settings.
15995184|NCT02925949|Behavioral|DuoPACT|6 couple-based intervention sessions are administered weekly by a counselor.
15995185|NCT02925949|Behavioral|LifeSteps|3 individual-based intervention sessions are administered weekly by a counselor.
15995186|NCT02925936|Other|Thyroid facing the anode end of xray machine|Thyroid position: facing the anode end of xray machine
15995187|NCT02925936|Other|Thyroid facing the cathode end of xray machine|Thyroid position: facing the cathode end of xray machine
15995188|NCT02925923|Drug|Ticagrelor|After randomization, a blood sample will be obtained at baseline for platelet function study, the study drugs, crushed ticagrelor will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests.
15995189|NCT02925923|Drug|Eptifibatide|After randomization, a blood sample will be obtained at baseline for platelet function test, the study drugs, clopidogrel and eptifibatide bolus will be administered. Patients will undergo PCI using drug-eluting stents or bare-metal stents. Blood samples will be obtained at 30 mins, 2, 4, and 24 h after PCI for platelet function tests.
15995190|NCT02925923|Drug|Clopidogrel|
15995191|NCT02925910|Device|Shock absorbing wheelchair|2 randomised groups will try the softwheel wheelchair compare to regular one, but in different order.
15995192|NCT02925897|Behavioral|Behaviour change and motivational interviewing|nurses will help patients to identify health behaviours that they would like to change and to explore their motivation and strengths to achieve this.
15995193|NCT02925884|Device|Gunnar OTC Glasses Condition|Gunnar Over-The-Counter Computer Glasses have optical power of 0.5 diopter for reducing accommodation demands at typical computer-viewing distance. The lens also have a partially transmissive yellow tinting and anti-reflective coating for filtering part of the spectral peaks in typical fluorescent or incandescent light. The frame has a wrape-around design meant to reduce air flow in the vicinity of the eyes.
15995194|NCT02925858|Drug|Normal Saline Flush, 0.9% Injectable Solution_#1|Normal saline infusion mimicking infusion rate of ketamine for a given weight
15995195|NCT02925858|Drug|Ketamine Hydrochloride|Ketamine IV infusion (0.5mg/kg bolus prior to incision, 0.5mg/kg/hr until the end of surgery)
15995196|NCT02925845|Device|Neuromuscular electrostimulation|The device CompexTheta 400i provided with various developmental programs rehabilitation exercise with different phases, types and current is used. an adaptive program (heating, toning, muscular atrophy, strength-endurance) will be established for each patient during the study period. It shall apply at the level of the muscle bellies of the flexor and extensor muscles of the forearm dela upper extremity AV created. Electrodes are positioned at the anatomical reference positions. The intensity of the current will increase until a tolerable muscle contraction and painless by the patient.
15995197|NCT02925832|Procedure|Deep Topical Fornix Nerve block anesthesia|DTFNB would be performed using two sponges (2x3mm) soaked with either 0.5% bupivacaine or 0.75% ropivacaine, applied deep in the conjunctival fornices after anaesthetising the conjunctiva with proparacaine local anaesthetic drops. The sponges are to be removed after 15 minutes.
15995198|NCT02925832|Drug|Ropivacaine|0.75% ropivacaine soaked sponges
15995199|NCT02925832|Drug|Bupivacaine|0.5% bupivacaine soaked sponges
15995200|NCT02925832|Drug|Proparacaine|For anaesthetising conjunctiva
15995201|NCT02925806|Other|Non-interventional study - retrospective database review|
15995202|NCT02925793|Drug|DS107|
15995203|NCT02925793|Other|Vehicle cream|
15995416|NCT02924428|Device|Venus Versa|
15995205|NCT02925780|Device|Microabrasion|"The labial surfaces of teeth selected for this group will be isolated and precleaned. Subsequently, the microabrasive material, Opalustre, will be applied according to the manufacturer's instructions, using a rubber cup at low speed (5 times each for 5 seconds). Between each of the applications the surface is washed by flushing water using a syringe.
~Digital images are taken before and after the treatment as well as at the follow-up visits (3, 6, 9 and 12 months)."
15995206|NCT02925767|Device|311-nm Ti:Sapphire laser|Pallas, LaserOptek, South Korea
15995207|NCT02925767|Device|308-nm excimer laser|XTRAC, PhotoMedex, US
15995208|NCT02925741|Other|Silk-Like Linens|Synthetic moisture-wicking fabric
15995209|NCT02925728|Other|Finger-Food|Finger-Food at lunch and having diner
15995210|NCT02925728|Other|Without Finger-Food|Without finger-food
15995211|NCT02925715|Procedure|ultrasound guided central venous cannulation|ultrasound is a medical device which is frequently used for safe venous punctures as you can visualise the structures.so, device ''ultrasound'' will be used for intervention ''central line insertion'' in subclavian vein. ultrasound guided cannulation of the subclavian vein was done by supraclavicular or infraclavicular approach after randomization into either of the two groups.In the supraclavicular approach the puncture site is above the clavicle while in the infraclavicular group the puncture site is below the clavicle. Central venous cannulation is done after identifying the vein on ultrasound and using standard seldinger technique with full asepsis.
15995212|NCT02925702|Drug|Radium 223 55mBq/Kg every 4 weeks intravenously|Radium-223 55kBq/kg infusion IV every 4 weeks
15995213|NCT02925676|Device|hyposafe H02|hypoglycaemia notification device
15995214|NCT02925663|Behavioral|EFI-E|This is 10 web-based modules addressing foundational EF skills. Each online module will be accompanied by a videoconference with a therapist to review the skills and problem solve around adolescent-identified goals.
15995215|NCT02925650|Drug|Posiphen|oral solid dosage form capsule
15995216|NCT02925650|Drug|Placebo|oral solid dosage form capsule
15995217|NCT02925637|Other|FaCoT|The intervention will include: functional activities, cognitive activities and strategies (pencil-pen treatment), and behavioural strategies
15995218|NCT02925624|Procedure|Pulmonary vein isolation|
15995219|NCT02925611|Drug|Isoflurane|
15995220|NCT02925611|Drug|Desflurane|
15995221|NCT02925598|Device|I-gel LMA insertion|'I-gel LMA insertion' was done following anesthesia induction.
15995222|NCT02925598|Device|AuraGain LMA insertion|'AuraGain LMA insertion' was done following anesthesia induction.
15995223|NCT02925598|Device|ETT insertion|'ETT insertion' was done following anesthesia induction.
15995224|NCT02925585|Other|Pre/post imaging|
15995225|NCT02925572|Other|Cycling exercises|All measurements are performed before and after the training program (12 weeks)
15995226|NCT02925559|Drug|Dapagliflozin|The active treatment will include a 10 mg dose of dapagliflozin orally once a day.
15995227|NCT02925559|Drug|Gliclazide MR|As comparator, gliclazide MR will be administered at a dose of 120 mg orally once a day.
15995228|NCT02925546|Drug|GSK2798745 Micronized API without SLS and hypermellose (Tablet A)|This is an immediate release tablet containing 2.4 mg of micronized GSK2798745 API; to be administered orally with 240 mL of water under fasted/fed conditions
15995229|NCT02925546|Drug|GSK2798745 Micronized API with SLS and hypermellose (Tablet B)|This is an immediate release tablet containing 2.4 mg of micronized GSK2798745 API with SLS and hypermellose; to be administered orally in fasted/fed conditions with 240 mL of water
15995230|NCT02925546|Drug|GSK2798745 milled API without SLS and hypermellose (Tablet C)|This is an immediate release tablet containing 2.4 mg of milled GSK2798745 API with SLS and hypermellose; to be administered orally in fasted/fed conditions, with 240 mL of water
15995231|NCT02925533|Drug|B-701|B-701 is a phage-derived, affinity-matured, human monoclonal antibody (mAb) specific for FGFR3. It is based on a human immunoglobulin G1 (IgG1) framework containing heavy chain VHIII and light chain VκI subgroup sequences.
15995232|NCT02925533|Drug|Pembrolizumab|Pembrolizumab is an mAb that binds to the programmed cell death protein 1 (PD-1) receptor and blocks its interaction with programmed death-ligand 1 (PD-L1) and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth.
15995233|NCT02925520|Drug|Omegaven|"Therapy with Omegaven will be provided at a dose of 1 gm/kg/day infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. Parenteral fat emulsion (Intralipid) will be administered only if necessary to administer adequate calories during Omegaven therapy. The same standards of care provided to all patients receiving parenteral nutrition solution will be followed.
~Home Use of Omegaven:
~The Omegaven dose for home use will be the same as that used while in the hospital: 1 gm/kg/day. As with the inpatient part of the protocol, this is a maximum dose and may be decreased at the discretion of the provider."
15995234|NCT02925507|Other|Swallowing Screen|Patient will be ask to undergo a swallowing screen by study staff
15995235|NCT02925494|Drug|Estradiol/Norethindrone Acetate|capsules
15995236|NCT02925494|Drug|Elagolix|film-coated tablets
15995237|NCT02925481|Behavioral|Moderate Online yoga participation|Phase 1: Testing yoga videos for emotional regulation and self-compassion which will inform the selected videos for Phase 2 prescription Phase 2: 150 minutes of Online streaming yoga videos completed at home. Week 1/2 introductory videos that include short video clips breaking down each pose Weeks 3-12 increase in difficulty (all videos are appropriate for beginners)
15995238|NCT02925481|Behavioral|Stretching and toning|Phase 1: Developing 12 week prescription for online control videos Phase 2: Online streaming stretching and toning videos completed at home which consist of a warm-up, 1 balance, 2 core, 2-3 upper body and lower body exercises, 6 stretches, cool-down
15995239|NCT02925481|Behavioral|Low dose online yoga participation|Phase 1: Testing yoga videos for emotional regulation and self-compassion which will inform the selected videos for Phase 2 prescription Phase 2: 60 minutes of Online streaming yoga videos completed at home. Week 1/2 introductory videos that include short video clips breaking down each pose Weeks 3-12 increase in difficulty (all videos are appropriate for beginners)
15995240|NCT02925468|Device|Bite turbo|In this study the nature and speed of adaptation of the occlusal changes following insertion of an anterior bite plane (bite turbos) for the reduction of a deep overbite in growing patients will be investigated.
16037268|NCT02615080|Drug|Placebo|
15995241|NCT02925455|Device|Contralaterally-controlled functional electrical stimulation|Contralaterally-controlled functional electrical stimulation (CCFES) is electrical stimulation of weak muscles of an impaired limb controlled via movement of the unimpaired contralateral limb.
15995242|NCT02925455|Device|Hand therapy video games|Hand therapy video games are designed to provide therapy to weak muscles of an impaired limb via goal-directed movements.
15995243|NCT02925442|Procedure|t-RFA|standard thermal genicular radiofrequency ablation
15995244|NCT02925442|Procedure|C-RFA|Cooled radiofrequency ablation
15995245|NCT02925442|Procedure|Control|Simulated radiofrequency ablation for placebo controlled group
15995246|NCT02925416|Drug|oritavancin|
15995247|NCT02925416|Drug|placebo (D5W)|
15995248|NCT02925403|Biological|R21/Matrix-M1|
15995249|NCT02925403|Other|Saline|
15995250|NCT02925377|Behavioral|Neuromuscular warm-up|The intervention group replaced their regular warm-up routine with seven neuromuscular warm-up exercises performed for 15 minutes prior to each practice session (3x/week) over a period of eleven weeks.
15995251|NCT02925377|Behavioral|Standard warm-up|Athletes in the control group followed their regular 15 minutes warm-up routine provided by the team coaches.
15995252|NCT02925364|Radiation|magnetic resonance imaging (MRI)|all participants will undergo a functional MRI and an anatomical MRI in a single session
15995253|NCT02925351|Procedure|Computed Tomography|Undergo PET/CT scan
15995254|NCT02925351|Radiation|Fluorine F 18 Clofarabine|Given IV
15995255|NCT02925351|Procedure|Positron Emission Tomography|Undergo PET/CT scan
15995257|NCT02925325|Behavioral|Music therapy|Music therapy (MT) treatment focuses on the use of 2 techniques of intervention: receptive MT and active MT. The work of receptive application is described as the use of prerecorded music or executed by the music therapist with effect on the patient, without the latter's active involvement in the psychotherapeutic process of musical creation. While the active application, both the music therapist and patient are involved in musical creation, for example, the use of voice, body and musical instruments (Muñoz, 2008). Contemplate their psychotherapeutic possibilities in 3 different dimensions of patient: body, emotional and social work, as explained above. Treatment with MT, as in cognitive behavioral therapy, includes breathing exercises, stress-relaxation techniques, psychoeducation, and exercises for the management of irrational thoughts and erratic behavior patterns (Dobson and Dozois, 2010).
15995258|NCT02925325|Other|Usual Treatment|It is the usual medical treatment that patients with major depressive disorder in remission but with residual symptom receives at the sponsor institution in a monthly basis.
15995259|NCT02925312|Other|Diabetes Pathway|Medication algorithm, survival skills education, enhanced patient-provider communication facilitated by near, real-time blood glucose monitoring
15995260|NCT02925299|Device|FlorenceM (US) and FlorenceX (UK)|"The automated closed loop system (FlorenceM in US) will consist of:
~Next generation sensor augmented Medtronic insulin pump 640G (Medtronic Minimed, CA, USA) incorporating the Medtronic Guardian3 CGM and glucose suspend feature.
~The automated closed loop system (FlorenceX in UK) will consist of:
~The DANA Diabecare R insulin pump (Sooil Development, Korea) incorporating the Dexcom G6 CGM.
~An Android smartphone containing the Cambridge model predictive algorithm and communicating wirelessly with the insulin pump using a proprietary translator device."
15995261|NCT02925299|Device|Insulin pump therapy|Subjects will continue using their own insulin pump for 6 months.
15995262|NCT02925286|Other|Prevention program for gambling in the workplace|The intervention group will receive a gambling prevention program which includes generating and implementing policies and education on addiction and gambling. The full length of the program will be about 14 hours.
15995263|NCT02925273|Other|palmar grasp without dorsal stimulation|"The patient will then be asked to keep the arms at 90 degrees and the researcher will slightly stroke palm and fingers of both hands of the patient simultaneously. After completion of each technique, the presence or absence of the response will be noted. In addition, the prominence of the response on the rating scale will be obtained as explained below.
~The scaling of the grasp response is as followed:
~Flexion at the distal interphalangeal joint of the hand
~Flexion at the proximal interphalangeal joint of the hand
~Flexion at the metacarpal-phalangeal joint of the hand"
15995264|NCT02925273|Other|standard palmar grasp test with dorsal stimulation|The patient will be asked to put their arms at 90 degrees and the researcher will hold one hand at the wrist and dorsum of the palm and lightly stroke the palm and fingers. The patient will be instructed to relax hands and not hold on while doing the grasp and see if the response persists. The same technique will be repeated for the patient's other hand.
15995265|NCT02925260|Other|MRI with ileal pouch contrast and enema.|Pre enema 20mg IV or IM Hyoscine Butylbromide (Buscopan) Pre enema Small Field of View (SFOV) T2 sagittal series Pre enema SFOV T2 axial series Pre enema SFOV T1 sagittal series (fat suppressed) Pre enema SFOV T1 axial series (fat suppressed) Enema infiltration started During enema filling Dynamic T1 sagittal single image, fat suppressed, aligned on pouch-anal anastomosis During enema filling T1 sagittal series (fat suppressed) During enema filling T1 axial series (fat suppressed) Jelly infiltrated and held Evacuating series Oblique sagittal T2 evacuating series of the mid and distal pouch, aligned to the pouch-anal anastomosis
15995266|NCT02925247|Behavioral|Adherence to oral anticoagulant treatment|The adherence will be evaluated by biological results
15995332|NCT02924922|Device|Conventional laparoscopic instruments|Endoscope, Scissor, Needleholder, Forceps, Suction unit, Ports, Tissel, CO2, Sutures, Needles, Scalpel, Ultrasound-Probe, Monitors
16038330|NCT02607683|Drug|Matching placebo|
15995333|NCT02924922|Device|Da- Vinci Robot and conventional laparoscopic instruments|Da Vinci Robot, Console, Ports and Instruments; Suction unit, Forceps, Tisseel, Ultrasound Probe, Monitors
15995334|NCT02924922|Drug|Mannitol|
16038331|NCT02607670|Drug|TAT4 Gel|
15995300|NCT02925208|Other|cochlear implant surgery|patients with severe to profound sensorineural hearing loss who underwent cochlear implant surgery
15995301|NCT02925195|Dietary Supplement|Vitamin D3|cholecalciferol (vitamin D3) 2000 IU capsules daily
15995302|NCT02925195|Drug|Placebo|
15995303|NCT02925182|Device|Er,Cr:YSGG Laser|
15995304|NCT02925169|Device|CT Scan|CT imaging
15995305|NCT02925143|Other|E-learning course in neuromuscular monitoring|An e-learning course designed to assess the challenges and common problems experienced by anesthetists when monitoring the neuromuscular blockade during general anesthesia.
15995306|NCT02925130|Drug|Salbutamol|Acute intake of Albuterol, a beta2-mimetic, either inhaled or oral.
15995307|NCT02925130|Drug|Placebo|Acute oral intake of a placebo drug
15995308|NCT02925117|Drug|Upadacitinib|Tablet for oral use
15995309|NCT02925117|Drug|Placebo|Tablet
15995310|NCT02925104|Drug|INC280|
15995311|NCT02925078|Device|Biohorizons Tapered Internal Implant, Laser-Lok, Resorbable Blast Textured (RBT)|Placement of implant in a subject with <2 mm mucosa thickness or a subject with ≥2 mm mucosa thickness.
15995312|NCT02925065|Other|Non-traditional group guitar instruction|A 6-week curriculum for non-traditional training in finger-style guitar has been developed with rhythmic and goal oriented upper extremity and finger movements. Guitar group intervention will be implemented at the Towson campus of the Peabody Preparatory. Intervention approaches will include rhythmic digital grip with finger isolation, goal directed rhythmic reach on the fret-board and rhythmic alternating tap-like digit and hand movements on the guitar. Participants will be provided with the instruments in the group setting without expectation of practice at home.
15995313|NCT02925052|Device|Gastric Tube Guide|
15995314|NCT02925052|Device|Conventional placement|
15995315|NCT02925039|Other|Rehab with computer feedback|Sit to stand training with addition of computerised feedback (speed, symmetry and trunk tilt)
15995316|NCT02925039|Other|Treatment as usual|Treatment as usual
15995317|NCT02925026|Dietary Supplement|Lactoferrin|
15995318|NCT02925026|Dietary Supplement|Lysozyme|
15995319|NCT02925026|Dietary Supplement|Placebo|
15995320|NCT02925013|Procedure|Blood sampling|Blood sampling for lipid profile
15995321|NCT02925013|Other|Dietary- Normal western diet|Normal western diet
15995322|NCT02925000|Drug|TLC178|TLC178
15995323|NCT02924987|Drug|Aflibercept Injection|Intravitreal injections of 0.05 mL (2mg) of Aflibercept will be injected. The intravitreal between the first 5 treatments sessions is 4 weeks, and the interval for the following treatment sessions up to week 52 is 8 weeks.
15995324|NCT02924974|Drug|Morphine|mixed with bupivacaine
15995325|NCT02924974|Drug|Lidocaine|sham procedure (s.c. lidocaïne)
15995326|NCT02924961|Device|Triathlon PS total knee system with mobile-bearing|
15995327|NCT02924961|Device|Triathlon PS total knee system with fixed-bearing|
15995328|NCT02924948|Procedure|Balloon inflation|EUS balloon inflation will be done before insertion through the subjects throat
15995329|NCT02924935|Dietary Supplement|L-Histidine|L-Histidine in 500mg capsules taken at a dose of 50mg/kg to maintain high-normal serum histidine levels
15995330|NCT02924922|Procedure|Laparoscopic partial nephrectomy|The renal hilus is identified and both vein and artery are dissected. A laparoscopic ultrasound probe is introduced through a 12 mm port to define the tumor resection margins. A laparoscopic Satinsky clamp is used to induce total kidney ischemia, clamping both vein and artery. Athermal resection of the tumor is performed and titanium clips are used to close interlobar or arcuate arteries encountered during resection. The defect is closed with stitches secured by Hem-o-Lok clips and haemostatic glue. Ischemia is interrupted once renorrhaphy is completed
15995331|NCT02924922|Procedure|Robot assisted partial nephrectomy|The renal hilus is carefully dissected, so that the arterial segmental branches are reached. Tumor resection margins are identified through ultrasound. Drop-in bulldog clamps are used to clamp segmental arterial branches and induce selective ischemia. Indocyanine green 0.2-0.3mg/KG is infused intravenously a few seconds after the selective ischemia is induced. The Firefly near infra-red fluorescence system is used to determine the extent of the ischemic area. The ischemic zone can now be tailored to the tumor by adding or removing bulldog clamps according to the vascular anatomical conditions. Athermal resection of the tumor is performed and titanium clips are used to close interlobar or arcuate arteries encountered during resection. The resection defect is closed with stitches secured by Hem-o-Lok clips and haemostatic glue. Selective ischemia will be interrupted once renorrhaphy is completed
15995336|NCT02924896|Dietary Supplement|Palm olein|60g of palm olein will be given in a milkshake at breakfast
15995337|NCT02924896|Dietary Supplement|Interesterified palm olein|60g of interesterified palm olein will be given in a milkshake at breakfast
15995338|NCT02924896|Dietary Supplement|Soybean oil|60g of soybean oil will be given in a milkshake at breakfast
15995339|NCT02924883|Drug|Atezolizumab|Atezolizumab 1200 mg IV infusion
15995340|NCT02924883|Drug|Trastuzumab emtansine|Trastuzumab emtansine 3.6 mg/kg IV infusion
15995341|NCT02924883|Other|Placebo|Placebo matched to atezolizumab
15995342|NCT02924870|Other|Health education program|"2 sessions, at 15 and 30 days after hospital discharge. The first session will consist of four stages:
~Basic formation: basic lung anatomy and physiology, COPD concept, importance of tobacco, diagnostic tests for COPD, and how COPD is treated.
~Care in COPD: diet, breathing exercises, physical exercise (walking, cycle, treadmill ...), lifestyle (clothing, hygiene, preening, exercise, rest, sexuality, social relations).
~Management of conventional treatment: inhalers, oxygen therapy and smoking cessation.
~Action Plan: the patient and the nurse will establish a target about the activities that the patient must perform as well as their frequency and duration, according to WHO guidelines.
~Second session: changes from the previous session; compliance with the physical activity plan and the deviation causes; weaknesses of the patient; skills in the management of inhalers, oxygen, and breathing exercises; and a new physical activity plan."
15995343|NCT02924870|Other|Conventional management|Treatment and follow-up according to conventional clinical practice (GesEPOC guidelines), including recommendations on healthy habits and lifestyle.
15995344|NCT02924857|Device|Chocolate Touch|The Chocolate Touch™ Paclitaxel Coated Balloon Catheter is indicated for balloon dilatation, after appropriate vessel preparation as needed, of lesions in native superficial femoral or popliteal arteries up to 18 cm in length that are appropriate for angioplasty with balloon diameters from 3.5 mm to 6.0mm.
15995345|NCT02924857|Device|Lutonix Drug Coated Balloon|The Lutonix® 035 Drug Coated Balloon Catheter is indicated for improving luminal diameter for the treatment of obstructive de novo or non-stented restenotic lesions (≤ 18 cm in length) in native femoropopliteal arteries having reference vessel diameters of 4 mm to 6 mm.
15995346|NCT02924831|Other|Acupuncture|Stimulating acupoints by using stainless steel needles with manual manipulation.
15995347|NCT02924831|Other|moxibustion|Stimulating acupoints by using burned moxa
15995348|NCT02924831|Other|placebo|Stimulating acupoints by using stainless steel needles without manual manipulation.
15995349|NCT02924818|Other|Clinical assessment|
15995350|NCT02924818|Behavioral|questionnaires|
15995351|NCT02924818|Other|pulmonary function test|
15995352|NCT02924818|Biological|blood test|
15995353|NCT02924818|Biological|microbiology|
15995354|NCT02924818|Biological|histology|
15995355|NCT02924818|Other|imaging|
15995356|NCT02924805|Other|Telemedical care|Telemedically guided care based on a standard operating procedure
15995357|NCT02924792|Device|Reinfusion - Sternal IO needle|
15995358|NCT02924792|Device|Reinfusion - Intravenous needle|
15995359|NCT02924779|Other|No intervention|Retrospective observational study
15995360|NCT02924766|Drug|Niraparib|Participants will start with niraparib 200 mg once daily.
15995361|NCT02924766|Drug|Apalutamide|Participants will receive apalutamide 240 mg (4*60 mg) once daily orally.
15995362|NCT02924766|Drug|Abiraterone Acetate|Participants will receive 1000 mg (4*250mg) once daily.
15995363|NCT02924766|Drug|Prednisone|Participants will receive 10 mg (1*5 mg twice daily).
15995364|NCT02924753|Drug|Cyclophosphamide|patients will receive a standard pre-conditioning regime with cyclophosphamide 0.8-1.0g/m2/day IV for 2 days(Day-5 to day-4).
15995365|NCT02924753|Drug|Fludarabine|Fludarabine 25mg/m2/day IV for 3 days (Day-5 to day-3).
15995366|NCT02924753|Biological|CART-19 cells|CART-19 cells will be administered using a split dose on day0(10%), 1(30%), and 2(60%) after completion of the chemotherapy.
15995367|NCT02924740|Behavioral|Pelvic Floor Muscle Training|Pelvic floor muscle training consist of fast (2 second) and slow contractions (5-s contraction, 10-s hold, 5-s relaxation, totally 20-s). One set of exercises includes ten fast and ten slow voluntary PFM contractions (VPFMCs). During week 1 and 2, participants will be instructed to perform two sets of exercises per day (20 fast and 20 slow contractions per day), which was progressively increased by two sets: four sets per day at week 3 and 4 (40 fast and 40 slow contractions per day); six sets per day at week 5 and 6 (60 fast and 60 slow contractions per day); eight sets per day at week 7 and 8 (80 fast and 80 slow contractions per day); ten sets per day from week 9 to week 12 (100 fast and 100 slow contractions per day).
15995368|NCT02924740|Behavioral|Vaginal Tampon Training|Vaginal tampon training will be applied for 5 days a week for 12 weeks. Exercises with tampons will be performed two days a week by physiotherapist (first author) and three days a week by patients. One set of tampon exercises consist 15 contractions. During vaginal tampon training, from week 1 to week 12, patients were instructed to perform two sets of exercises for five days a week (two days by physiotherapist, three days by themselves).
15995369|NCT02924727|Drug|LCZ696 (sacubitril/valsartan)|LCZ696 (sacubitril/valsartan) tablet will be available in 24/26 mg, 49/51 mg and 97/103 mg, respectively
15995370|NCT02924727|Drug|Ramipril|Ramipril 1.25 mg, 2.5 mg, and 5 mg oral capsules
15995371|NCT02924727|Drug|Placebo of LCZ696|Matching placebo of LCZ696 tablets
15995372|NCT02924727|Drug|Placebo of ramipril|Matching placebo of ramipril capsule
15995373|NCT02924727|Drug|Valsartan|Valsartan (VAL489) 40 mg and 80 mg tablets, two doses for 1 day to patients who were previously treated with ACE inhibitors receiving the last dose of that agent during the last 36 hours prior to randomization
15995374|NCT02924727|Drug|Placebo of valsartan|matching placebo of valsartan for one day to patients who will be randomized to received ramipril
15995375|NCT02924714|Other|Discontinuation of imatinib|
15995376|NCT02924701|Other|Blood samples, fibroscan and questionaires|
15995377|NCT02924688|Drug|FF/UMEC/VI (100/31.25/25) mcg|Dry white powder delivered via the ELLIPTA DPI (one inhalation once-daily [QD] in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 100 mcg in each blister and the second strip contains UMEC 31.25 mcg and VI 25 mcg in each blister.
15995417|NCT02924415|Behavioral|Tele-care support|Psychoeducation treatment based on telemedicine
15995378|NCT02924688|Drug|FF/UMEC/VI (100/62.5/25) mcg|Dry white powder delivered via the ELLIPTA DPI (one inhalation, QD in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 100 mcg in each blister and the second strip contains UMEC 62.5 mcg and VI 25 mcg in each blister.
15995379|NCT02924688|Drug|FF/UMEC/VI (200/31.25/25) mcg|Dry white powder delivered via the ELLIPTA DPI (one inhalation, QD in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 200 mcg in each blister and the second strip contains UMEC 31.25 mcg and VI 25 mcg in each blister.
15995380|NCT02924688|Drug|FF/UMEC/VI (200/62.5/25) mcg|Dry white powder delivered via the ELLIPTA DPI (one inhalation, QD in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 200 mcg in each blister and the second strip contains UMEC 62.5 mcg and VI 25 mcg in each blister.
15995381|NCT02924688|Drug|FF/VI (100/25) mcg|Dry white powder delivered via the ELLIPTA DPI (one inhalation, QD in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 100 mcg in each blister and the second strip contains VI 25 mcg in each blister.
15995382|NCT02924688|Drug|FF/VI (200/25) mcg|Dry white powder delivered via the ELLIPTA DPI (one inhalation, QD in the morning). The ELLIPTA DPI holds 2 individual blister strips with 30 blisters on each strip: the first strip contains FF 200 mcg in each blister and the second strip contains VI 25 mcg in each blister.
15995383|NCT02924688|Drug|Fluticasone/salmeterol (FSC)|Dry white powder delivered via the DISKUS DPI (one inhalation twice daily: one in the morning and one in the evening). The DISKUS DPI holds a strip of 60 blisters; each blister contains FP 250 mcg and 50 mcg of salmeterol.
15995384|NCT02924688|Drug|Albuterol/salbutamol|This is a rescue medication administered via metered-dose inhaler (MDI) which will be used when needed during the study.
15995385|NCT02924688|Device|ELLIPTA DPI|The ELLIPTA device will be used during the stabilization period and the treatment period. The ELLIPTA DPI is a moulded plastic two-sided device that can hold two individual blister strips which contain powder formulation for oral inhalation.
15995386|NCT02924688|Device|DISKUS DPI|The DISKUS device will be used during the run-in period. The DISKUS DPI is a plastic inhalation delivery system containing a single-foil blister strip of a powder formulation of FSC for oral inhalation.
15995387|NCT02924688|Device|METERED-DOSE INHALER (MDI)|Albuterol/salbutamol (rescue medication) will be delivered via metered-dose inhaler (MDI) will be used for reversibility testing.
15995388|NCT02924675|Drug|Pregabalin|150mg daily in three doses during three weeks
15995389|NCT02924675|Drug|Placebo|Three doses daily with lactose
15995390|NCT02924662|Other|There is no intervention.|
15995391|NCT02924649|Procedure|Early Intensive mobilisation|The intervention will be performed using a tilt table with integrated stepping movements of the lower extremity (ERIGO, HOCOMA, Switzerland). The goal of the intervention session is that the patient stands upright for 20 minutes. If orthostatic intolerance or increase in intracranial pressure occurs the session will be paused. When the patient is stable mobilization is continued.
15995392|NCT02924636|Behavioral|ePPOP-ID program|This is a personalized and online program. The website will provide secure communication with dietician and lifestyle coaches.
15995393|NCT02924597|Procedure|zero ischemia robot-assisted laparoscopic RFA assisted TE|
15995394|NCT02924597|Procedure|zero ischemia robot-assisted laparoscopic partial nephrectomy|
15995395|NCT02924571|Procedure|Bone Marrow Aspirate Concentrate (BMAC)|Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest (BMAC+ ALLOGRAFT) or
15995396|NCT02924571|Procedure|Recombinant Human Bone Morphogenetic Protein-2 (BMP)|INFUSE rhBMP-2 Bone Graft (BMP). Using the standard technique for anterior lateral fusion, the bone graft from group 1 or 2 will be laid onto the decorticated transverse processes, lateral aspects of the facets, par interarticularis, and onto the facets.
15995397|NCT02924558|Other|Egg protein/unsaturated fatty acid|Study test foods (yogurt, muffins, waffles, and cookies) containing 8% higher protein energy (egg protein) and 8% higher fat energy (unsaturated fatty acids) than Control
15995398|NCT02924558|Other|Control|Study test foods (yogurt, muffins, waffles, and cookies) containing 16% higher carbohydrate energy than Egg protein/unsaturated fatty acid
15995399|NCT02924532|Biological|immediate post operative bioassay of Parathyroid Hormone|
15995400|NCT02924506|Device|Mobi-C prothesis|Mobi-C Prothesis, LDR Medical (company)
15995401|NCT02924506|Device|ProDisc-C prothesis|ProDisc-C prothesis, Vivo Depuy Synthes (company)
15995402|NCT02924493|Other|Diet low in fermentable carbohydrates (low FODMAP diet)|The participants follow the diet in 4 weeks. They have been provided with some foods (bread, pasta, cereal products), but will by the rest themselves. They have been provided with lists of foods to include and foods to avoid. They have also been provided with suggestions to a 4 week meal plan, based in their individual need for energy.
15995403|NCT02924480|Procedure|Cystectomy|
15995404|NCT02924480|Drug|Lidocaine|Patients will receive lidocaine infusion during surgery
15995405|NCT02924480|Drug|Saline|Patients will receive saline infusion during surgery
15995406|NCT02924467|Behavioral|1 Notice|1 Reminder notification via autodialer
15995407|NCT02924467|Behavioral|2 Notices|2 Reminder notifications via autodialer
15995408|NCT02924467|Behavioral|3 Notices|3 Reminder notifications via autodialer
15995409|NCT02924454|Drug|metoprolol|One hundred and twenty ml, 0.5 mg metoprolol/ml (as metoprolol tartrate) is administered as an intravenous bolus injection followed by a continuous infusion. Infusion is halted if heart rate drops below 35 bpm or systolic blood pressure drops below 80 mm Hg, or the participant experiences subjective side effects. Infusion stops at T=30 minutes.
15995410|NCT02924454|Drug|intravenous lipid emulsion|Intravenous lipid emulsion 20 % is administered as an intravenous bolus infusion (1.5 ml/kg) followed by continuous infusion (infusion rate: 0.25 ml/kg/min). Lipid emulsion infusion is stopped at T = 30 minutes.
15995411|NCT02924454|Drug|Sodium chloride 0.9% solution - lipid emulsion dummy|Isotonic 0.9 % sodium chloride solution is administered as an intravenous bolus infusion (1.5 ml/kg), followed by continuous infusion (infusion rate: 0.25 ml/kg/min). Infusion is stopped at T = 30 minutes.
15995412|NCT02924454|Drug|Sodium chloride 0.9% solution - metoprolol dummy|Saline solution is administered as an intravenous bolus injection followed by a continuous infusion to T=30 minutes.
15995413|NCT02924441|Other|Lidocaine|Applied to breast skin
15995420|NCT02924389|Drug|dolutegravir|Tivicay is a human immunodeficiency virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. 50 mg of Tivicay (dolutegravir) will be taken orally once a day in combination with Truvada.
15995421|NCT02924389|Drug|Triumeq|Triumeq is a fixed-dose combination drug for the treatment of HIV/AIDS. It is a combination of 600 mg abacavir, 50 mg dolutegravir and 300 mg lamivudine. Triumeq will be taken orally once daily.
15995422|NCT02924389|Drug|Truvada|Truvada is a combination of emtriva and viread, both nucleoside analog HIV-1 reverse transcriptase inhibitors. Truvada is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection. One Truvada tablet (containing 200 mg/300 mg of emtricitabine and tenofovir disoproxil fumarate) will be taken orally once daily in combination with Tivicay (dolutegravir).
15995424|NCT02924363|Diagnostic Test|Cardiac MRI with or without contrast dye|MRI scans of the heart are performed before and after the MitraClip clinical procedure with an FDA cleared device with or without an FDA approved contrast dye.
15995425|NCT02924363|Diagnostic Test|Blood sample|Blood samples collected to calculate hematocrit for measurements of the CMR extracellular matrix.
15995426|NCT02924350|Other|Stannous fluoride|"Supervised direct application (Day 0): Participants applied a pea-sized dose of test dentifrice to each of the 2 qualifying test teeth using their washed and clean finger to gently rub the dentifrice into the tooth's cervical margin for 60 sec. No rinsing was permitted after treatment.
~Supervised brushing (Day 0, before leaving the site) and Home use (3 days): after dosing a dry toothbrush with a full strip of dentifrice, participants brushed each of the 2 qualifying test teeth first, followed by their whole mouth for at least 60 sec. Participants were permitted to rinse with 5 mL tap water (room temperature) for 5 sec. maximum after brushing on supervised brushing (Day 0) and were also permitted to rinse with tap water after brushing on home use (3 days)."
15995427|NCT02924350|Other|Sodium monofluorophosphate|"Supervised direct application (Day 0): participants applied a pea-sized dose of control dentifrice to each of the 2 qualifying test teeth using their washed and clean finger to gently rub the dentifrice into the tooth's cervical margin for 60 sec. No rinsing was permitted after treatment.
~Supervised brushing (Day 0, before leaving the site) and home use (3 days): after dosing a dry toothbrush with a full strip of dentifrice, participants brushed their whole mouth thoroughly for at least 60 sec. Participants were permitted to rinse with 5mL tap water (room temperature) for 5 sec. maximum after brushing in supervised brushing on Day 0 and were also permitted to rinse with tap water after brushing on home use (3 days)."
15995428|NCT02924337|Drug|Placebo|
15995429|NCT02924337|Drug|Imeglimin|
15995430|NCT02924337|Drug|Moxifloxacin|
15995431|NCT02924324|Device|propofol|
15995432|NCT02924324|Drug|ropivacaine|
15995433|NCT02924324|Behavioral|Wong-Baker FACES® Pain Rating Scale|Nurses will record patient-reported pain scores.
15995434|NCT02924324|Behavioral|Post-procedural quality of life (QOL)|
15995435|NCT02924311|Drug|Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)|Eylea 40 mg/mL - recommended dose of 2 mg - intravitreal injection monthly for five consecutive months, which constitutes the loading dose. The loading dose is followed by one injection every two months. After 12 months of treatment, the interval between two injections can be prolonged or adapted according to visual and anatomical results.
15995436|NCT02924298|Behavioral|SLIMM|Participants will perform 5 minutes of light activity for every 25 minutes spent seated for 12 weeks. Following the week 12 visit, participants will increase light activity to 10 minutes for every 20 minutes spent seated.
15995437|NCT02924285|Procedure|Procedure (Radiofrequency catheter ablation)|Radiofrequency catheter ablation
15995438|NCT02924285|Drug|Amiodarone|"Amiodarone, Verification of superiority of catheter ablation over amiodarone for treatment of PVCs in patients with structural heart disease as:
~Antiarrhythmic Drug Amiodarone"
15995439|NCT02924272|Drug|Ixazomib|Ixazomib Capsules
15995440|NCT02924259|Device|The GRID foam roll|Commercial rigid foam roll with an outer foam covering
15995441|NCT02924246|Biological|cholera vaccination|Oral cholera vaccination on day 0 and day 14
15995442|NCT02924246|Other|raw milk|raw milk
15995443|NCT02924246|Other|pasteurized milk|pasteurized milk
15995444|NCT02924246|Other|UHT milk|UHT milk
15995445|NCT02924233|Drug|Sym004|"Sym004 is a 1:1 mixture of two monoclonal antibodies (mAbs) which bind to two non-overlapping epitopes of the Epidermal Growth Factor Receptor (EGFR).
~Sym004 will be administered at different dose-levels via infusion Q2W"
15995446|NCT02924233|Drug|Nivolumab|Nivolumab is a humanized immunoglobulin G4 (IgG4) anti-PD-1 monoclonal antibody. Nivolumab will be administered via 60-minute infusion Q2W
15995447|NCT02924207|Other|PATH electronic decision support tool|PATH, a clinical decision support tool for Type 2 Diabetes, was developed based on patient impact of efficacy, cost, implementation difficulty, comorbidities, side effects, and evidence based pleiotropic benefit. Drug efficacy was estimated using published clinical data for agents, both in terms of placebo controlled trials and head-to-head studies. Additional information regarding interventions was added with regard to FDA package inserts as well as large post marketing studies. Cost impact of intervention was described in terms of patient's estimated copay drawn from insurance plan as well as average retail price.
15995448|NCT02924194|Device|stimulation ON|"The system used in the study includes the Model 37601 Activa PC stimulator, Model 3387 Lead and Model 37085 Extension, all manufactured and commercially available by Medtronic, Inc. Collectively, these devices will be referred to as the DBS System. The DBS System is commercially available in the United States and was approved by FDA on July 31, 1997 under PMA P960009. It is indicated for deep brain stimulation for the treatment of symptoms of Parkinson's disease and essential tremor."
15995449|NCT02924194|Device|stimulation OFF|"The system used in the study includes the Model 37601 Activa PC stimulator, Model 3387 Lead and Model 37085 Extension, all manufactured and commercially available by Medtronic, Inc. Collectively, these devices will be referred to as the DBS System. The DBS System is commercially available in the United States and was approved by FDA on July 31, 1997 under PMA P960009. It is indicated for deep brain stimulation for the treatment of symptoms of Parkinson's disease and essential tremor."
15995450|NCT02924181|Device|SmartTouch Catheter|Pulmonary vein (PV) isolation guided by CF information
15995451|NCT02924168|Device|Active Radial Shockwave|Four weekly sessions of active radial shockwave treatment.
15995452|NCT02924168|Device|Sham Radial Shockwave|Four weekly sessions of sham radial shockwave treatment.
15995453|NCT02924155|Drug|SJP002|
15995454|NCT02924155|Drug|Placebo|
15995455|NCT02924142|Device|OT Cap attachment|The RHEIN 83 OT CAP attachment system is an extra-coronal castable attachment positioned on the distal of the abutment crowns as an extension allowing a lot of vertical space for optimal esthetics.
15995457|NCT02924116|Device|Bioboosti|Subjects will place the device on the palm of their hand for 8 minutes. There is a light on the device that changes to indicate that the 8 minutes have passed. They will then place it on the palm of the other hand and keep it there for 8 minutes. Alternating 8-minute cycles between hands will be done up to 6 times.
15995458|NCT02924103|Device|Contamination free bacterial swab|"A comparison of the bacteriology in bacterial swabs (Eswab 481CE, Copan Diagnostics, Italy) from the middle meatus. On the RIGHT side using the Contamination free bacterial swab introduction device that facilitates the introduction of a bacterial swab into the nose without direct or indirect contact with the nasal vestibule."
15995459|NCT02924090|Drug|Etomidate|Etomidate will be administered as a bolus intravenously to induce an adequate depth of anesthesia just prior to ECT at a dose of 0.3 mg/kg
15995460|NCT02924090|Drug|Ketamine|Ketamine will be administered as a bolus intravenously to induce an adequate depth of anesthesia just prior to ECT at a dose of 0.5 to 1.0 mg/kg.
15995461|NCT02924090|Procedure|Hyperventilation|Hyperventilation will be performed in patients after full pre-oxygenation and induction of anesthesia, by administering 20 breaths in 30 seconds using a well-fitting face mask immediately before application of the ECT electrical stimulus.
15995462|NCT02924090|Procedure|Electroconvulsive therapy (ECT)|Bilateral, bitemporal electrode placement will be utilized to elicit a seizure via a SpECTrun 5000Q (MECTA Inc.). The electrical dose required will be determined in advance by the patient's attending psychiatrist.
15995463|NCT02924064|Drug|Teneligliptin 20mg|
15995464|NCT02924064|Drug|Placebo|
15995465|NCT02924064|Drug|Metformin ≥ 1000 mg|
15995466|NCT02924051|Behavioral|Motivational Interviewing|"Baseline and monthly assessment of barriers/facilitators of dietary change, ambivalence to change and coaching to resolve barriers and ambivalence."
15995467|NCT02924051|Behavioral|Cooking skills and nutritional education|Participants in this group will develop an understanding of healthy food options and healthy food preparation.
15995468|NCT02924038|Biological|IMA950|IMA950 vaccine
15995469|NCT02924038|Biological|poly-ICLC|poly-ICLC vaccine
15995470|NCT02924038|Biological|Varlilumab|Intravenous solution
15995471|NCT02924025|Behavioral|Motivational interview|Motivational interview is an interview form based on the patients own thoughts of motivation. It will be conducted by a nurse who is specially trained in this interview type.
15995472|NCT02924012|Other|video game active|The session lasted 40 minutes. The participants held an active video game session. At the end they were monitored for 60 minutes at rest.
15995473|NCT02924012|Other|sedentary video game|The session lasted 40 minutes. The participants held an sedentary video game session, using the traditional joystick. At the end they were monitored for 60 minutes at rest.
15995474|NCT02924012|Other|walking|The session lasted 40 minutes. The participants held a walk using the treadmill. At the end they were monitored for 60 minutes at rest.
15995475|NCT02923999|Drug|P2G12 Dose Cohort 1|single dose of intravenous infusion: 0.125g of the P2G12 human monoclonal antibody
15995476|NCT02923999|Drug|P2G12 Dose Cohort 2|single dose of intravenous infusion: 0.25g of the P2G12 human monoclonal antibody
15995477|NCT02923999|Drug|P2G12 Dose Cohort 3|single dose of intravenous infusion: 0.5g of the P2G12 human monoclonal antibody
15995478|NCT02923986|Drug|BP1001 (varying dose)|BP1001 (varying dose)
15995479|NCT02923986|Drug|BP1001 (fixed dose)|BP1001 (fixed dose)
15995480|NCT02923986|Drug|Dasatinib|Dasatinib
15995481|NCT02923973|Other|Transvaginal ultrasound cervical length screening|Serial transvaginal ultrasound cervical length scan every week from 16 to 24 weeks
15995482|NCT02923960|Other|Standard ONS|One serving (237 ml) standard oral nutritional beverage
15995483|NCT02923960|Other|Diabetes specific ONS 1|One serving (237 ml) diabetes oral nutritional beverage
15995484|NCT02923960|Other|Diabetes specific ONS 2|One serving (296 ml) diabetes oral nutritional beverage
15995485|NCT02923947|Drug|Osimertinib; AZD9291|80mg tablet dose to be taken orally - single dose in part A, daily dosing in Part B and continued access until progression or no longer receiving benefit
15995486|NCT02923934|Drug|Ipilimumab|CTLA-4 (cytotoxic T-lymphocyte-associated protein 4) is a key regulator of T cell activity. Ipilimumab is a CTLA-4 immune checkpoint inhibitor that blocks T-cell inhibitory signals induced by the CTLA-4 pathway, increasing the number of tumor reactive T effector cells which mobilize to mount a direct T-cell immune attack against tumor cells. CTLA-4 blockade can also reduce T regulatory cell function, which may lead to an increase in anti-tumor immune response.
15995487|NCT02923934|Drug|Nivolumab|A fully human immunoglobulin (Ig) G4 monoclonal antibody directed against the negative immunoregulatory human cell surface receptor programmed cell death-1 (PD-1,PCD-1) with immune checkpoint inhibitory and antineoplastic activities. Nivolumab binds to and blocks the activation of PD-1, an Ig superfamily transmembrane protein, by its ligands programmed cell death ligand 1 (PD-L1), overexpressed on certain cancer cells, and programmed cell death ligand 2 (PD-L2), which is primarily expressed on APCs (antigen presenting cells). This results in the activation of T-cells and cell-mediated immune responses against tumor cells or pathogens. Activated PD-1 negatively regulates T-cell activation and and plays a key role in in tumor evasion from host immunity.
15995488|NCT02923921|Biological|Pegilodecakin|Pegilodecakin plus FOLFOX
15995489|NCT02923921|Drug|FOLFOX|FOLFOX Alone
15995490|NCT02923908|Other|Noldus Facereader 7|A video recording of a subject's facial expressions while tasting a sweet, bitter, and neutral flavored liquid will be analyzed using Noldus Facereader 7 software.
15995491|NCT02923908|Other|Voice Recording|A voice recording will be made for the duration of the tasting period.
15995572|NCT02923388|Drug|Placebo pill|Placebo pill orally thrice daily for 5 weeks
15995710|NCT02922491|Dietary Supplement|starch|daily intake of starch (control)
16038332|NCT02607670|Drug|Matching placebo|
15995492|NCT02923908|Other|5-Point Facial Hedonic Scale|A 5-point facial hedonic scale will be given to the participant to complete prior to the administration of any test substances and about 5, 10, and 30 minutes after the administration of each test substance.
15995493|NCT02923908|Other|Follow-Up Questionnaire|Participants will be asked a few questions about each test agent after tastings.
15995494|NCT02923895|Other|Stannous fluoride|0.454% weight by weight (w/w) stannous fluoride containing 1100 parts per million (ppm) fluoride
15995495|NCT02923895|Other|Sodium monofluorophosphate|0.76% w/w sodium monofluorophosphate containing 1000 ppm fluoride
15995496|NCT02923882|Other|'$100Kitchen and improved cookstove'|
15995497|NCT02923869|Drug|Levobupivacaine|Children will receive 0.15 ml/kg of 0.2% Levobupivacaine through bilateral suprazygomatic MNB.
15995498|NCT02923869|Drug|Bupivacaine|Children will receive 0.15 ml/kg of 0.2% Bupivacaine through bilateral suprazygomatic MNB.
15995499|NCT02923856|Device|The results of clarithromycin susceptibility test of H. pylori isolates|According to the results of antibiotic susceptible testing, patients who were resistant to clarithromycin were belonged into clarithromycin resistance group.Patients who were sensitive to clarithromycin were belonged into the 7days/10days/14days treatment groups.
15995500|NCT02923856|Device|Computer generated random number, randomly assigned into groups|The patients with clarithromycin sensitive. Computer generated random number,randomly assigned into 7days/10days/14days treatment groups.
15995501|NCT02923856|Device|The result of 13C-urea breath test of patient in 7days/10days/14days treatment groups|The intervention focused on the results from the result of 13C-urea breath test at 8 weeks after treatment in patients. All patients were taking 75mg 13C-urea and analysis with a modified isotope ratio mass spectrometer to determine the 13CO2 content.The successful treatment groups were patients with negative in 13C-urea breath tests.The failed treatment of H. pylori groups were patients with positive in 13C-urea breath tests after the standardized triple therapy treatment.
15995502|NCT02923843|Other|Comprehensive Geriatric Assessment|The CGA is person-centered and unique for each patient, but is based on the core elements such as socio-demographic background, social network, health and medical history, medications, functional status, cognitive status, nutritional status, somatic status and psychosocial status including depression, providing a comprehensive assessment tailored for each person.
15995503|NCT02923830|Other|Heparinized saline catheter flush|The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months
15995504|NCT02923830|Drug|Saline-only catheter flush|The intervention group will have their port catheters flushed with saline only.
15995505|NCT02923817|Biological|Transplantation of autologous bone marrow-derived mononuclear cells by lumbar injection|
15995506|NCT02923804|Dietary Supplement|Omega-3|3x 1g capsules taken daily for 6 months
15995507|NCT02923804|Dietary Supplement|Olive oil|3x 1g capsules taken daily for 6 months
15995508|NCT02923791|Biological|Filgrastim Hospira|5 consecutive daily doses (Days 1-5) in Period 1 and 1 dose (Day 1) in Period 2.
15995509|NCT02923791|Biological|US-Approved Neupogen|5 consecutive daily doses (Days 1-5) in Period 1 and 1 dose (Day 1) in Period 2.
15995510|NCT02923778|Radiation|Radiation Therapy|Undergo radiation therapy
15995511|NCT02923778|Biological|Talimogene Laherparepvec|Given IT or via intralesional injection
15995512|NCT02923765|Other|Aerobic training by a stepper|Aerobic training by a stepper: 35 minutes/session, 5 sessions/week and 4-5 weeks in total
15995513|NCT02923752|Device|MRI|Contrast-enhanced MRI
15995514|NCT02923739|Biological|Bevacizumab|Given IV
15995515|NCT02923739|Biological|Emactuzumab|Given IV
15995516|NCT02923739|Other|Laboratory Biomarker Analysis|Correlative studies
15995517|NCT02923739|Drug|Paclitaxel|Given IV
15995518|NCT02923739|Other|Pharmacological Study|Correlative studies
15995519|NCT02923726|Device|Arm 1 (ATP+Shock)|Subjects will be randomized and device programmed to the respective arm.
15995520|NCT02923726|Device|Arm 2 (shock only)|Subjects will be randomized and device programmed to the respective arm.
15995521|NCT02923700|Biological|Leukocyte-rich PRP intra-articular injections|
15995522|NCT02923700|Biological|Leukocyte-poor PRP intra-articular injections|
15995523|NCT02923687|Drug|Ketorolac Tromethamine|All patients will receive standard inferior alveolar nerve block of 2% lidocaine with 1:800000 epinephrine and supplemental buccal infiltration of 0.9 mL 2% lidocaine with 1:800000 epinephrine. After five minutes, the experimental group will receive supplemental buccal infiltration of 30 mg/mL of Ketorolac Tromethamine.
15995524|NCT02923687|Drug|Placebo|All patients will receive standard inferior alveolar nerve block of 2% lidocaine with 1:800000 epinephrine and supplemental buccal infiltration of 0.9 mL 2% lidocaine with 1:800000 epinephrine. After five minutes, control group will receive buccal infiltration of normal saline.
15995525|NCT02923674|Behavioral|Weight loss|All participants will undergo a dietary WL intervention designed to elicit behavioral changes leading to decreased caloric intake sufficient to yield a ~10% loss of initial body mass. The WL intervention includes nutrition education, state-of-the-art behavioral methods for promoting WL, and strategies that optimize self-regulation.
15995526|NCT02923674|Behavioral|Exercise|Perform structured aerobic exercise (mostly treadmill walking) of moderate-intensity for 4-5 days/week, progressing to a duration of 200 min/week. Participants will attend center-based sessions for at least 3 days/week during the first intensive 6-month phase and at least one day/week during the second 3-month transition phase (months 7-9), with recording of home-based exercise for the other 2-4 days/week.
15995527|NCT02923674|Behavioral|Sitless|Encouraged and taught to reduce sedentary behavior (SB) during waking hours. The SitLess treatment targets increases in postural shifts and light, spontaneous physical activity (SPA) (MET level <3).
15995528|NCT02923661|Device|CM LOC|
15995529|NCT02923661|Device|ball attachment|
15995530|NCT02923635|Procedure|Standard wide local excision.|Excision of breast cancer without integration of plastic technique
15995531|NCT02923635|Procedure|oncoplastic breast surgery.|Integration of plastic techniques with oncological surgery for resection of breast cancer.
15995532|NCT02923622|Other|Traditional Chinese medicine herbals|TCM herbal treatment based on TCM syndrome differentiation，without any anti tumor therapy in Western Medicine
15995860|NCT02921282|Genetic|Genotype dopamine|Laboratory investigations of nicotine reinforcement
15995533|NCT02923622|Other|Integrated traditional Chinese and Western medicine|TCM herbal treatment combine with anti tumor therapy in Western Medicine ( including non recommended chemotherapy, radiotherapy and targeted therapy in clinical guidelines)
15995534|NCT02923622|Other|Western medicine|Anti tumor therapy in Western Medicine ( including non recommended chemotherapy, radiotherapy and targeted therapy in clinical guidelines)
15995535|NCT02923609|Biological|Cell Therapy|Electro-anatomical mapping will be performed using the Biosense NOGA system (Biosense-Webster, Diamond Bar, California). Local diastolic function will be assessed by a novel algorhithm that allows for the measuring local ventricular relaxation times at each of the sampling points. Target areas for cell delivery will be defined as the myocardial segments with the evidence of local diastolic dysfunction and myocardial hibernation. Transendocardial delivery of cell suspension in the SC Group will be performed with MyoStar® (Biosense Webster) injection catheter. Each patient will receive 20 injections of 0.3 mL of stem cell suspension.
15995536|NCT02923596|Procedure|History of prior Surgery|History of prior Surgery will be reviewed
15995537|NCT02923596|Radiation|History of Radiation Therapy|History of prior radiation therapy will be reviewed
15995538|NCT02923583|Biological|M834|
15995539|NCT02923583|Biological|US-Sourced Orencia®|
15995540|NCT02923583|Biological|EU-Sourced Orencia®|
15995541|NCT02923570|Radiation|Photon intensity modulated radiation therapy (IMRT)|
15995542|NCT02923570|Radiation|Proton beam radiotherapy (PBRT)|
15995543|NCT02923557|Drug|Pirarubicin|single immediate intravesical dose of pirarubicin (THP) intravesical therapy (THP 40 mg for 30 min) within 24 hours of nephroureterectomy.
15995545|NCT02923531|Drug|X4P-001|X4P-001 will be administered as per the dose and schedule specified in the arm.
15995546|NCT02923531|Drug|Nivolumab|Nivolumab will be administered as per the dose and schedule specified in the arm.
15995547|NCT02923518|Other|Questionnaire|Observational study without any intervention described under intervention type
15995548|NCT02923505|Procedure|polygraphy or polysomnography|
15995549|NCT02923492|Behavioral|SafERteens|A 30 minute private on-on-one brief motivational interviewing intervention given during emergency department care. The goal of the intervention was to reduce and prevention youth violence using techniques to change behavior in a respectful, non-confrontational, and non-judgmental manner. This one-on one counseling approach emphasizes individual choice and responsibility and differentiates between future goals/values and current behavior
15995550|NCT02923479|Device|Specific ankle rehabilitation by ARBOT device|ARBOT is a programmable robotic device consisting in a two-degree-of-freedom electromechanical platform developed by Italian Institute of Technology - Advanced Robotics and Rehab Technologies. It is composed of a fixed base, a central strut, a moving platform supporting patient's foot and three actuated limbs with a universal-prismatic-spherical kinematic chain. A six-axis force/torque sensor mounted between the moving platform and the footplate senses the human-robot interaction force and torque. The device is interfaced to a standard all-in-one touch screen Personal Computer with graphic applications to give patients visual feedback in real time.
15995551|NCT02923479|Other|General Rehabilitation|All patients underwent general rehabilitation (gait training, aerobic conditioning), including - if necessary - an initial weight training phase before the functional full weight-bearing program.
15995552|NCT02923479|Other|Specific ankle rehabilitation performed by physiotherapist|Subjects in the control group underwent manually assisted range of motion exercises.
15995553|NCT02923479|Device|Specific ankle rehabilitation by Biodex System 3 dynamometer|Subjects in the control group performed non-robotic resistive training using a Biodex System 3 dynamometer
15995554|NCT02923479|Device|Specific ankle rehabilitation by ProKin PK254 platform|Subjects in the control group performed non-robotic proprioceptive training using a ProKin PK254 mobile electronic platform.
15995555|NCT02923466|Biological|VSV-IFNβ-NIS|Intratumoral injection of a single dose of VSV-IFNβ-NIS
15995556|NCT02923466|Biological|VSV-IFNβ-NIS and avelumab|Intratumoral injection of a single dose of VSV-IFNβ-NIS and intravenous infusion of avelumab
15995557|NCT02923453|Dietary Supplement|CNT 2000 American ginseng extract|
15995558|NCT02923453|Dietary Supplement|Placebo|
15995559|NCT02923440|Biological|blood sample|
15995560|NCT02923427|Device|Laryngeal mask Supreme Evaluation|Evaluation of clinical performance in terms of Insertion, ventilation and complications
15995561|NCT02923427|Device|i-gel Evaluation|Evaluation of clinical performance in terms of Insertion,ventilation and complications
15995562|NCT02923414|Device|Standard escalating shocks|125 J, 150 J, 200 J
15995563|NCT02923414|Device|High energy shock protocol|360 J, 360 J, 360 J.
15995564|NCT02923401|Other|Exercise|"High-Intensity Interval Training (HIIT) Group: Participants walk uphill on a treadmill for a total of 33 minutes 3 times a week for 12 weeks.There is a 5-minute warm up, followed by four 4-minute intervals. Between each interval, participant walks for 3 minutes. There is a 3 minute cool down.
~Moderate-Intensity Continuous Training (MICT) Group: Participants walk uphill on a treadmill or use a stationary bicycle continuously for 41 minutes 3 times a week for 12 weeks."
15995565|NCT02923401|Behavioral|Questionnaires|Participants complete questionnaires about their quality of life, exercise experience, and level of fatigue at baseline and at 12 weeks. These should take a total of about 15 minutes to complete.
15995566|NCT02923401|Behavioral|Motivational Session|One (1) time each month, participant attends a motivational session for 12 weeks.
15995567|NCT02923401|Behavioral|Phone Call|Participants called by a member of the study staff 1 time each week for 12 weeks and asked about any exercise they have done and their weight loss goals. Each phone call should take about 15 minutes.
15995568|NCT02923401|Other|Printed Materials|"High-Intensity Interval Training (HIIT) Group and Moderate-Intensity Continuous Training (MICT) Group: Participants receive written materials and instructions on how to perform their exercises.
~Control Group: Participants receive written materials and counseling by an exercise physiologist."
15995569|NCT02923388|Drug|Injection Mecobalamin,|Injection Mecobalamin (500mcg) three times a week (day 1, 3 and 5 of vincristine chemotherapy) for 5 weeks.
15995570|NCT02923388|Drug|Tablet Pyridoxine hydrochloride|Tab. Pyridoxine hydrochloride (25 mg) 2 tablets thrice daily for 5 weeks
15995571|NCT02923388|Drug|Intravenous normal saline 1 ml|Normal saline 1 ml three times a week (day 1, 3 and 5 of vincristine chemotherapy) for 5 weeks
15995573|NCT02923375|Biological|Mesenchymoangioblast-derived mesenchymal stem cells|The active agent in CYP-001 is allogeneic mesenchymoangioblast-derived mesenchymal stem cells (MCA-derived MSCs), which are produced using the proprietary Cymerus™ platform technology. Cymerus™ refers to the process of generating cell-based products from intermediate cells, MCAs, which in turn are derived from induced pluripotent stem cells or iPSCs. The iPSCs used in the Cymerus™ process were derived from blood donated by a fully-consented healthy adult donor, and were reprogrammed using a transgene-free, viral-free and feeder-free technique.
15995574|NCT02923362|Procedure|Laparoscopic Fundoplication|The gastric fundus of the stomach is wrapped or plicated around the lower end of the esophagus and and stitched in place reinforcing the closing function of the lower esophageal sphincter. The hiatus is also narrowed down with sutures or mesh to prevent or treat a concurrent hiatal hernia.
15995575|NCT02923362|Device|LINX Antireflux|The LINX is a flexible band of interlocked titanium beads with a magnetic core. The LINX is placed around the lower esophageal sphincter to help restore the function of the LES by preventing reflux into the esophagus.
15995576|NCT02923349|Drug|INCAGN01949|Initial cohort dose of INCAGN01949 monotherapy at the protocol-defined starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose will be taken forward into expansion cohorts.
15995577|NCT02923336|Drug|non selective beta blocker|"the patient is going to receive a device called smart pill before the beginning of treatment with propranolol, after the evaluation with the smart pill device, they are goning to take propranolol (dose of propranolol 80 mg per day) for 4 weeks,finally they will receive another smart pill to evaluate the second gastrointestinal transit time"
15995578|NCT02923323|Device|MRI including DTI , EEG, CGMS|Will be connected to continuous simultaneous systems
15995579|NCT02923323|Behavioral|Neurocognitive tests|Will perform multiple tests of neurocognitive functions after lunch
15995580|NCT02923310|Biological|Platelets Rich Plasma|
15995581|NCT02923310|Biological|Leucocyte - Platelets Rich Plasma|
15995582|NCT02923310|Drug|Hialuronic Acid|
15995583|NCT02923297|Other|Blood sampling|blood sampling for determine and compare the expression patterns of GALIG gene
15995584|NCT02923271|Device|CellControl|Technology that blocks incoming and outgoing calls and texts. CellControl Drive ID will monitor all cellphone use while driving (without blocking) for 3 weeks during baseline measurement period. During the intervention period (5 weeks) cellphone use will be monitored and blocking of incoming calls and texts will be active.
15995585|NCT02923258|Drug|Docetaxel|20mg/m2/w for 6 weeks
15995586|NCT02923258|Drug|Cisplatinum|40mg/m2/w for 6 weeks
15995587|NCT02923258|Radiation|IMRT|a total dose of 60Gy in 30 fractions over 6 weeks
15995588|NCT02923245|Other|point-of-care ultrasound|
15995589|NCT02923232|Device|Accommodative contact lens|Different downgaze angles will be experimented to determine whether the accommodative contact lens can alter its optical refraction at downgaze angles.
15995590|NCT02923219|Biological|Adipose-derived stem cells|The adipose-derived stem cells therapy involve injection of patient's own adipose-derived stem cells. Local anesthetic will be applied to the face prior to the injection. For adipose-derived stem cells preparation, proper volume of fat cells will be collected from each patient just before each procedure. The stem cells will be injected into each standardized injection point in a superficial manner. The injections points are along the inferior border of cheek and mid-cheek and temple, where will be followed by 10-15 minutes of icing.
15995591|NCT02923206|Device|TheraSorb sFlt-1 adsorber|Removal of excessive sFlt-1 from the plasma of subjects/ patients with therapeutic apheresis.
15995592|NCT02923193|Device|Shockwave Lithoplasty® Peripheral Lithoplasty System|The Shockwave Lithoplasty® System is a proprietary lithotripsy-enhanced balloon catheter that is designed to be delivered through the peripheral arterial system of the lower extremities to the site of calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy electrodes, and a generator.
15995593|NCT02923193|Drug|Medtronic IN.PACT (DCB)|The IN.PACT Admiral DCB is an over-the-wire (OTW) balloon catheter with a drug-coated balloon at the distal tip. The drug component, referred to as the FreePac™ drug coating, consists of the drug paclitaxel and the excipient urea. The device component physically dilates the vessel lumen by PTA, and the drug is intended to reduce the proliferative response that is associated with restenosis.
15995594|NCT02923180|Drug|Enoblituzumab|Enoblituzumab 15mg/kg IV (in the vein) weekly for 6 doses beginning 50 days prior to radical prostatectomy.
15995596|NCT02923154|Drug|MT-3995|
15995597|NCT02923154|Drug|Placebo|
15995598|NCT02923141|Behavioral|Neutral Writing|
15995599|NCT02923141|Behavioral|Expressive Writing|
15995600|NCT02923141|Behavioral|Contingency Management|
15995601|NCT02923128|Drug|Dexmedetomidine|Dexmedetomidine 150ug is diluted to 150ml with 0.9% saline,continuous micro-pump infusion for 72 hours with 2ml/h speed.
15995602|NCT02923128|Drug|Sufentanyl|Sufentanyl(0.06ug.kg-1.h-1) is diluted to 150ml with 0.9% saline,continuous micro-pump infusion for 72 hours with 2ml/h speed.
15995603|NCT02923128|Drug|Saline|Saline is used to dilute other drugs
15995604|NCT02923115|Drug|DS-1040b|Single, continuous intravenous infusion over 12 to 24 hours (depending on cohort)
15995605|NCT02923115|Drug|Placebo|Single, continuous intravenous infusion of 0.9% sodium chloride over 12 to 24 hours
15995606|NCT02923115|Drug|Enoxaparin|Subcutaneous injection 1 mg/kg twice daily
15995607|NCT02923102|Dietary Supplement|Aloysia citriodora extract|2 capsules with 200mg - daily dosage 400mg
15995608|NCT02923102|Dietary Supplement|Maltodextrin|2 capsules with 200mg - daily dosage 400mg
15995653|NCT02922855|Behavioral|50 dollars group|Those assigned to the $50 group will receive $50 if they visit their PCP within 6 months of study enrollment.
15995609|NCT02923089|Other|Muffin: 25g available carbohydrate from small green lentil|Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
15995610|NCT02923089|Other|Muffin: 25g available carbohydrate from split red lentil|Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
15995611|NCT02923089|Other|Wheat muffin|Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
15995612|NCT02923089|Other|Soup: 25g available carbohydrate from small green lentil|Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
15995613|NCT02923089|Other|Soup: 25g available carbohydrate from split red lentil|Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
15995614|NCT02923089|Other|Potato soup|Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
15995615|NCT02923089|Other|Chili: 25g available carbohydrate from small green lentil|Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
15995616|NCT02923089|Other|Chili: 25g available carbohydrate from split red lentil|Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
15995617|NCT02923089|Other|Rice chili|Comparison of postprandial blood glucose and insulin following consumption of food products with and without lentils.
15995618|NCT02923076|Other|CCR5 delta32/delta32 cord blood transplantation|
15995619|NCT02923063|Behavioral|Combined Aerobic and Resistance Exercise via videoconferencing|Combined aerobic and resistance exercise session thrice weekly for 12 weeks
15995620|NCT02923050|Behavioral|Simple Suppers|Theory-based 10-week family meals program
15995621|NCT02923037|Procedure|Yoga|Complete guided and home yoga sessions
15995622|NCT02923037|Other|tape measurement of arm|Ancillary studies
15995623|NCT02923037|Other|Quality-of-Life Assessment|Ancillary studies
15995624|NCT02923037|Other|ldex measurement of arms|
15995625|NCT02923024|Behavioral|Patient Ping|The patient ping will be a fax sent from Oscar Health to physician that will include information on the physician's patient's trigger event and contact information for the physician to reach out to the member.
15995626|NCT02923011|Device|MRgFUS|Magnetic resonance-guided focused ultrasound ablation of osteoid osteoma
15995627|NCT02923011|Device|CTgRFA|Computed tomography-guided radiofrequency ablation of osteoid osteoma
15995628|NCT02922985|Drug|Intravenous acetominophen|One dose if 1 gram intravenous to be given pre-surgery
15995629|NCT02922985|Drug|Ketorolac, intramuscular|One dose of 60 mg Intramuscular to be given at time of skin closure
15995630|NCT02922985|Drug|Bupivacaine, subcutaneous|Inject 20 mL of 0.25% bupivacaine at the site of anticipated skin incision.
15995631|NCT02922985|Drug|Normal saline|Normal saline will be given intravenously, intra-muscularly, and subcutaneously in the same volume as the study drugs for the patients in the placebo group.
15995632|NCT02922972|Device|Autologous Platelet Rich Plasma obtained with RegenKit®-BCT|After complete resection of the keloid scar, the first injection was administered before closure into the lesion resection bed and edges. Three additional injections were administered with a one-month interval.
15995633|NCT02922959|Behavioral|Peer Intervention|The Peer Intervention is a 20-minute telephone call delivered by a Peer Interventionist, who is trained to answer questions about the content of the personally-tailored information packets. The primary goal of the call is for the participant and the Peer Interventionist to have an open exchange of information about medication-assisted treatment (MAT) for opioid use disorder.
15995634|NCT02922959|Drug|naloxone nasal spray kit|Naloxone nasal spray (NARCAN) is a potentially life-saving medication that can stop or reverse the effects of an opioid overdose. This nasal spray is approved by the FDA for reversing OODs and has a favorable side-effects profile. A take-home kit will be provided to the patient participants, which may be useful in the event of a future opioid overdose.
15995635|NCT02922959|Behavioral|Personally-tailored opioid overdose prevention education (information packet)|"Personally-tailored information packet with three participant-specific reports (Personal Overdose Risk Factors Report; Medication Assisted Treatment (MAT) Report; and the Opioid Overdose Information Report), and general written information about opioid overdose and treatment for opioid use disorder."
15995636|NCT02922946|Drug|Entinostat|HDAC (histone deacetylase) inhibitor
15995637|NCT02922933|Drug|entinostat|HDAC (histone deacetylase inhibitor)
15995638|NCT02922933|Dietary Supplement|Omeprazole|Proton pump inhibitor
15995639|NCT02922933|Dietary Supplement|Famotidine|Histamine-2 blocker
15995640|NCT02922920|Other|Tart cherry juice|16 fl. oz of tart cherry juice
15995641|NCT02922920|Other|Placebo|16 fl. oz of placebo
15995642|NCT02922907|Dietary Supplement|arabinoxylan rice bran|a proprietary product derived from rice bran treated with extracts from three mushrooms
15995643|NCT02922907|Dietary Supplement|Placebo for arabinoxylan rice bran|inactive product
15995644|NCT02922894|Procedure|Acute episodic hypoxia|The subjects will undergo 30 minutes of baseline monitoring followed by 15 episodes of one minute of episodic hypoxia with supplemental CO2 to maintain isocapnia. This is followed by a 45 minute recovery period.
15995645|NCT02922894|Procedure|Supplemental oxygen|Supplemental oxygen therapy for 6 weeks
15995646|NCT02922894|Drug|Trazodone|100mg before bedtime
15995647|NCT02922894|Drug|Placebo|One placebo pill before-bedtime
15995648|NCT02922894|Procedure|Sham|Room air will be administered instead of episodic hypoxia or supplemental oxygen..
15995649|NCT02922881|Other|Ulcerative Colitis Diet (UCD)|The primary study intervention is a novel dietary intervention, the UC Diet. The UC Diet is a structured 12-week diet with a step down phase designed to remove products that allow harmful bacteria to thrive and add products that can change the bacteria in the gut to induce remission
15995650|NCT02922868|Device|EndoSheath CST-5000 Scope|Cystoscopic procedures will be performed using the EndoSheath CST-5000 Scope.
15995651|NCT02922868|Device|Olympus Visera Elite OTV-S190 Scope|Cystoscopic procedures will be performed using the Olympus Visera Elite OTV-S190 Scope
15995652|NCT02922855|Behavioral|0 dollars group|Those assigned to the $0 group will not receive an incentive for visiting their PCP.
16038333|NCT02607657|Drug|Eplerenone 25 mg|
15995654|NCT02922855|Behavioral|25 dollars group|Those assigned to the $25 group will receive $25 if they visit their PCP within 6 months of study enrollment.
15995655|NCT02922842|Device|Transcutaneous Electrical Nerve Stimulation|
15995660|NCT02922803|Drug|1 combination tablet of Vitamin D3/calcium per day|Combination tablet of Cholecalciferol (800 IU or 20 ug) and calcium carbonate (500 mg)
15995661|NCT02922803|Drug|2 combination tablets of Vitamin D3/calcium per day|Combination tablets of Cholecalciferol (800 IU or 20 ug) and calcium carbonate (500 mg)
15995662|NCT02922790|Behavioral|standard health information|Subjects will review standard health information
15995663|NCT02922790|Behavioral|standard health information plus info. on DNA damage|Subjects will review standard health information and information on DNA damage
15995664|NCT02922790|Behavioral|Subjects will review standard health information and information on DNA damage, plus pictures of their DNA damage|Subjects will review standard health information and information on DNA damage, as well as review pictures of their cells' DNA damage
15995665|NCT02922777|Drug|BGB324|75 mg/m2 every 21 days
15995666|NCT02922777|Drug|Docetaxel|75 mg/m2 given IV every 21 days
15995674|NCT02922751|Other|Liver Stiffness Measurement (LSM)|LSM will be measured via transient elastography utilizing the non-invasive FibroScan™ ultrasound device. LSM will be measured at Baseline, Year 1 and Year 2 visits.
15995675|NCT02922738|Other|VisualDx|VisualDx is a computerized clinical information technology with medical image and text content in dermatology.
15995676|NCT02922725|Drug|5-hydroxytryptophan and Creatine|
15995677|NCT02922725|Other|Placebo control|
15995678|NCT02922712|Drug|NISE|Nise 200mg Max per day in 2 divided doses
15995679|NCT02922699|Drug|OMEZ 40|Omez 40 given to patients for 58days along with Amoxicilin and Clarithromycin
15995680|NCT02922699|Drug|OMEZ 80|Omez 80 patients for 58days along with Amoxicilin and Clarithromycin
15995681|NCT02922686|Drug|Flucloxacillin|One flucloxacillin capsule of 500mg strength taken four times daily for 7 days
15995682|NCT02922686|Drug|Phenoxymethylpenicillin|One capsule of phenoxymethylpenicillin of 500 mg strength taken four times daily for 7 days
15995683|NCT02922686|Drug|Placebo (for phenoxymethylpenicillin)|Over-encapsulation of phenoxymethylpenicillin will be performed by the manufacturer of the investigational medicinal products such that placebo and active phenoxymethylpenicillin are identical in size, shape, colour and smell, and are packaged in identical bottles
15995684|NCT02922673|Drug|Aspirin|
15995685|NCT02922673|Drug|Placebo|
15995686|NCT02922660|Drug|desflurane|method of anesthesia maintenance with desflurane ranged from 0.5~1.5 MAC during the procedure
15995687|NCT02922660|Procedure|total intravenous anesthesia|method of anesthesia in group TIVA is total intravenous anesthesia(TIVA) during the procedure
15995688|NCT02922660|Procedure|inhalation anesthesia|method of anesthesia in group DES is inhalation anesthesia with desflurane during the procedure
15995689|NCT02922660|Drug|Propofol|using propofol as sedative during the procedure of anesthesia and maintaining with propofol Cp 2-4 μg/ml in TCI
15995690|NCT02922660|Drug|Remifentanil|using remifentanil as analgesics during the procedure of anesthesia and maintaining with remifentanil 2-4 ng/ml in TCI
15995691|NCT02922647|Device|suprapubic catheterization|Experimental Arm: Suprapubic catheterization after rectal resection with low anastomosis for cancer in males
15995692|NCT02922647|Device|transurethral catheterization|Active comparator: Transurethral catheterization after rectal resection with low anastomosis for cancer in males
15995693|NCT02922634|Other|Mini Cog|short cognitive screen, short Frailty screen
15995694|NCT02922608|Other|simulation practice|simulation session
15995695|NCT02922595|Device|Intubation through ILMA®|"It will be placed into patient's larynx through the mouth in accordance with manufacturer's recommendations by experienced airway providers.
~Intubation will then be peformed"
15995696|NCT02922595|Device|Intubation through ILTS®|"It will be placed into patient's larynx through the mouth in accordance with manufacturer's recommendations by experienced airway providers.
~Intubation will then be peformed"
15995697|NCT02922582|Drug|DepoTXA|
15995698|NCT02922582|Drug|Tranexamic Acid|
15995699|NCT02922569|Other|Computerized Plasticity-Based Adaptive Cognitive Training|Thirty minutes of training on computerized exercises that targets processing speed, memory and attention.
15995700|NCT02922569|Other|Commercially available computerized training|Thirty minutes of training on computerized, casual video games.
15995701|NCT02922569|Other|Mindfulness Training|Ten minutes of using an online training course that teaches skills to help overcome ongoing life stressors.
15995702|NCT02922569|Other|Traumatic Brain Injury Information Session|Ten minutes of viewing traumatic brain injury related news, information, and programs.
15995703|NCT02922556|Other|Computerized Plasticity-Based Adaptive Cognitive Training|
15995704|NCT02922556|Other|Commercially available computerized training|
15995705|NCT02922530|Other|Computerized Plasticity-based Adaptive Cognitive Training|
15995706|NCT02922530|Other|Commercially available computerized training|
15995707|NCT02922504|Behavioral|Music intervention group|
15995708|NCT02922504|Behavioral|Controlled group|
15995709|NCT02922491|Dietary Supplement|vitamin E|daily intake of vitamin E
15995711|NCT02922478|Radiation|X-ray of the spine|Every participant will undergo X-ray of the spine so that vertebral fractures can be quantified using the Genant score.
15995712|NCT02922478|Procedure|Ambulatory blood pressure monitoring (ABPM)|ABPM will be performed using the brachial, oscillometric, automated self-measurement mobil-O-Graph device (I.E.M. GmbH, Stolberg, Germany) with integrated ARCSolver®-Software (Austrian Institute of Technology Wien).
15995713|NCT02922478|Radiation|Dual X-ray absorptiometry|Individual bone mineral density and T-Score will be determined by X-ray absorptiometry.
15995714|NCT02922478|Procedure|Non-invasive procedures|Other non-invasive study procedures include structured patient interview, sampling of blood, buffy coat and spot urine (including biobanking), electrocardiogram, pulse wave velocity and analysis, transthoracic echocardiography, 4-meter gait speed test, hand grip test, questionnaires
15995715|NCT02922465|Drug|K-877|
15995716|NCT02922465|Drug|Clopidogrel|
15995717|NCT02922452|Drug|BMS-986141|Single dose BMS-986141 and Multiple doses of Dilitazem
15995718|NCT02922452|Drug|Dilitazem|Single dose BMS-986141 and Multiple doses of Dilitazem
15995719|NCT02922439|Behavioral|Tailored Intervention|The intervention will focus on improving the health literacy of low literacy individuals by providing chronic disease self-management information tailored to cultural and linguistic characteristics of participants.
15995720|NCT02922439|Behavioral|Control Intervention|This intervention will provide information similar to that provided in the control condition, but will not utilize tailoring.
15995721|NCT02922426|Drug|ALKS 3831|Daily dosing for 21 consecutive days
15995722|NCT02922426|Drug|Olanzapine|Daily dosing for 21 consecutive days
15995723|NCT02922426|Drug|Placebo|Daily dosing for 21 consecutive days
15995724|NCT02922413|Biological|Hemin for injection|Panhematin 4 mg/kg body weight reconstituted with 25% human albumin infused intravenously over at least 1 hour.
15995725|NCT02922413|Other|Placebo|Saline infusion
15995726|NCT02922400|Behavioral|Social Cognition Assessment and Training|The study includes an assessment and treatment phase: The assessment phase will test the efficacy and feasibility of a battery of measures evaluating social cognition and behavior. Functional magnetic resonance imaging (fMRI) will also be used to investigate functional differences in regions of the brain associated with social cognition and differences in cognitive progressing. The treatment phase will assess the efficacy and feasibility of a strategy-based social skills treatment using a virtual reality platform.
15995727|NCT02922387|Drug|Varenicline|Varenicline was given for 12 weeks to all patients in group A. The initial dose was 0.5 mg/day for days 1-3, and was then up-titrated to 0.5mg on days 4-7, and finally to 1 mg twice daily from day 8 until the end of treatment
15995728|NCT02922387|Behavioral|Behavioral support|An initial private consultation session and motivational interview while still in the hospital that lasted for at least 60 minutes. Follow-up phone calls with a minimum duration of 10 minutes were scheduled in weeks 1, 2, 4, and months 3,6 and 9 following smoking cessation.
15995729|NCT02922374|Drug|corticosteroids|Intravenous steroids were started with methylprednisolone 60 mg/d or hydrocortisone 400 mg/d for 3 days.
15995730|NCT02922348|Drug|Hormone Replacement Therapy|Hormone replacement therapy as indicated in Arm 1
15995731|NCT02922348|Drug|Combined Oral Contraceptives|Combined oral contraceptives as indicated in Arm 2
15995732|NCT02922335|Behavioral|Multisystemic Therapy for Emerging Adults|MST-EA is a home-based therapy in which therapists work closely with each young adult. Therapists often also work with the young person's family, as appropriate. MST-EA is designed to help young people work on their own behavior. This treatment also involves the use of coaches who help young people develop skills for young adulthood.
15995733|NCT02922335|Behavioral|Enhanced Treatment as Usual|Standard services that a young person would receive if they have been in trouble with the law and also have a mental illness.
15995734|NCT02922322|Other|Pilates Group|The Pilates group program (PG) was composed of 16 sessions, 2x per week, 60 minute session each for 8 weeks. The intervention was based on 20 out of the 34 original mat exercises proposed by the Pilates method, classified into basic, intermediate or advanced levels divided into 4 cycles of 5 exercises each. The exercises were performed during two series of 10 repetitions respecting the patients skills.
15995735|NCT02922309|Behavioral|Vocal Training Via Telepractice|Vocal Training Via Telepractice, delivered by integrated communication service
15995736|NCT02922309|Behavioral|Vocal Training Via face-to face practice|Vocal Training Via face-to face practice at medical facilities
15995737|NCT02922283|Device|IL2-PET scan|All patients in this study will undergo a IL2 PET scan at baseline and week 6 of treatment with immunotherapy.
15995738|NCT02922283|Procedure|Tumor biopsy|A procedure to acquire tissue of a predetermined melanoma metastasis will be performed in all patients that participate in phase 2 of this study.
15995739|NCT02922283|Device|CT scan|A CT scan of diagnostic quality will accompany all the PET scans and will additionally been made 12 and 16 weeks after start of immunotherapy to evaluate response to treatment.
15995740|NCT02922283|Procedure|Biopsy of non-target tissue|A biopsy of skin and colon non-target tissue involved in an immune-related side effect is optional in patients that participate in phase 2 of this study.
15995741|NCT02922270|Other|Peritoneal dialysis patients at the Istanbul Medical Faculty|The aims of this study were to evaluate patient and technique survival rates, investigate peritonitis rates and evaluate factors affecting mortality in peritoneal dialysis (PD) patients over a period of 20 years at Istanbul Faculty of Medicine Peritoneal Dialysis Unit.
15995742|NCT02922244|Other|Control|Apply moisture cream to the treatment skin everyday after radiation therapy
15995743|NCT02922244|Other|Cucumber cream|Apply cucumber cream to the treatment skin everyday after radiation therapy
15995744|NCT02922244|Other|Centella cream|Apply centella cream to the treatment skin everyday after radiation therapy
15995745|NCT02922244|Other|Thunbergia cream|Apply thunbergia cream to the treatment skin everyday after radiation therapy
15995746|NCT02922231|Biological|RIXUBIS|Recombinant Factor IX (rFIX) for intravenous use
15995747|NCT02922205|Device|Endoscopic Linear Cutter Stapler and reloads|Endoscopic Linear Cutter Stapler and reloads
15995748|NCT02922192|Drug|TNF-α antagonists, non-TNFs, DMARD non-biologics|Exposure to TNF- α antagonists, non-TNF- α antagonists, oral DMARD, or non-biologic agents.
15995861|NCT02921282|Genetic|Genotype cannabinoids|Laboratory investigations of nicotine reinforcement
15995749|NCT02922179|Drug|Long- and intermediate- acting insulins|alone or in combination with metformin, short-acting insulin, or second-generation sulfonylurea
15995750|NCT02922166|Drug|SRX246|oral capsule
15995751|NCT02922166|Drug|Placebo|oral capsule
15995752|NCT02922153|Device|Cryoanalgesia|AtriCure® cryoICE cryo-ablation system
15995753|NCT02922153|Drug|Standard of Care|Institutional SOC for pain management will be followed.
15995754|NCT02922140|Behavioral|pharmaceutical care service|
15995755|NCT02922127|Drug|Ulipristal Acetate|Daily use of Ulipristal Acetate
15995756|NCT02922127|Drug|Combined Oral Contraceptive Pill|Daily use of Oral Contraceptive Pill
15995757|NCT02922114|Other|Ultrasonography|B-mode and power Doppler ultrasonography examination.Ultrasonography assessments includes wrists, metacarpophalangeal, proximal interphalangeal, elbows, shoulders, knees, ankles, metatarsophalangeal and twenty six tendons (wrist extensors, finger flectors and tendons of the ankles).
15995758|NCT02922101|Behavioral|Audit and Feedback|An online dashboard that provides insight into clinical performance on pain management quality indicators. It also incorporates an empty action plan, in which participating intensive care units can define potential bottlenecks in the care process and what actions they intend to undertake to improve.
15995759|NCT02922101|Behavioral|Toolbox|A quality improvement toolbox, incorporated within the action plan, that comprises for each pain management quality indicator (e.g., percentage of patients per shift whose pain is measured) a list of potential bottlenecks in the care process (e.g., staff is unaware of the prevailing guidelines for measuring pain every shift), associated recommendations for actions to solve mentioned bottlenecks (e.g., organize an educational training session), and supporting materials to facilitate implementation of the actions (e.g., a slide show presentation discussing the importance and relevance of measuring pain every shift).
15995760|NCT02922088|Device|DuraGraft|DuraGraft is a one-time intraoperative vascular graft treatment designed to prevent graft disease and failure and reduce the clinical complications associated with graft failure.
15995761|NCT02922075|Biological|Connective tissue graft|A 1.5 mm thick soft tissue graft removed from the palate with determined dimensions. The recipient site was prepared by performing laterally a delicate elevation of the facial tissue avoiding the mesial and distal papilla. The soft tissue graft length was equal to the horizontal distance between the two papillas and its length was set at 6 mm. Soft tissue grafts were placed at the level of the gingival margin and stabilized with simple interrupted sutures.
15995762|NCT02922075|Biological|Collagen matrix graft|A 15x20 mm collagen matrix trimmed according to determined dimensions. The recipient site was prepared by performing laterally a delicate elevation of the facial tissue avoiding the mesial and distal papilla. The soft tissue graft length was equal to the horizontal distance between the two papillas and its length was set at 6 mm. Soft tissue grafts were placed at the level of the gingival margin and stabilized with simple interrupted sutures.
15995763|NCT02922075|Device|Immediate implant|A conical implant with a morse-taper connection with moderate roughness implant surface was properly installed in the ideal tridimensional position with its platform placed 4 mm below the facial gingival margin. After tooth extraction and dental implant installation with a torque > 32 Ncm patients were randomized into three groups (8 patients per group): 1- No soft tissue graft, Control group (CTL); 2- Collagen Matrix group (CM); 3- Connective tissue graft group (CTG).
15995764|NCT02922075|Procedure|Tooth extraction|Compromised tooth was gently removed and the socket was debrided thoroughly, cleansed and inspected. The socket's palatal and apical bone was sequentially drilled. All surgeries were performed by the same surgeon and were individually planned according to the clinical and tomographic evaluation. Implant diameter was set as 3.5 mm and its length was selected according to the quantity of bone available apically to the fresh alveolar socket.
15995765|NCT02922075|Device|Immediate restoration|A titanium abutment was installed in the dental implant with manual torque and a prefabricated tooth shell was relined with resin material to fabricate cement or screw retained interim restoration. All interim restorations were installed in infra-occlusion matching the adjacent teeth color and form, with light proximal contacts and presented a subgingival concave contour.
15995766|NCT02922075|Biological|Bone regeneration|All sites received a non-cross linked collagen membrane and deproteinized bovine bone mineral containing 10% of porcine collagen.
15995767|NCT02922075|Drug|Post operative medication|Postoperative instructions were given, antibiotics were prescribed for 7 days (amoxicillin 500 mg t.i.d), analgesics to relieve from pain (Paracetamol 750 mg) and chlorhexidine 0.12% rinse twice a day for 15 days. Complementary, the patients were instructed to avoid chewing in the anterior region and to follow a soft diet.
15995768|NCT02922075|Device|Definitive prosthesis|Definitive implant-supported restorations were performed 6 months after dental implant placement.
15995769|NCT02922075|Other|No soft tissue graft|No soft tissue graft was used
15995770|NCT02922062|Other|Canola Oil|Subjects will be provided with all their meals prepared in our metabolic kitchen in order to control their diets. The major cooking oil used in food preparation will be canola oil. The meals will be tailored to the caloric needs of each individual in order to maintain their body weight.
15995771|NCT02922062|Other|Palm Oil|Subjects will be provided with all their meals prepared in our metabolic kitchen in order to control their diets. The major cooking oil used in food preparation will be palm oil. The meals will be tailored to the caloric needs of each individual in order to maintain their body weight.
15995772|NCT02922062|Other|Butter|Subjects will be provided with all their meals prepared in our metabolic kitchen in order to control their diets. The major cooking oils used in food preparation will be butter. The meals will be tailored to the caloric needs of each individual in order to maintain their body weight.
15995773|NCT02922049|Other|Biopsies with histopathology|All samples taken by biopsies will be correlated with the images taken by CLE.
15995774|NCT02922036|Device|WiSE System|The WiSE System is an implantable cardiac system to provide LV pacing stimulation in conjunction with a co-implanted system that provides right ventricular stimulation.
15995775|NCT02922023|Device|Ambulatory blood pressure monitor (ABPM)|"ABPM allows providers to obtain blood pressure readings over a 24 hour period, to assess blood pressure at night to determine dipping status, and to evaluate the efficacy of anti-hypertensive therapy."
15995776|NCT02922023|Other|Chronotherapy|Chronotherapy group will receive a shift in the timing of one of their antihypertensive medications to nighttime dosing without consulting their ABPM results.
15995777|NCT02921997|Drug|AS03|AS03 oil-in-water emulsion adjuvant.
15995778|NCT02921997|Biological|Influenza Virus Vaccine, Monovalent A/H3N2v A/Minnesota/11/2010 NYMC X-203|Inactivated monovalent subvirion H3N2v vaccine containing hemagglutinin (HA) of A/Minnesota/11/2010 NYMC X-203 virus.
15995779|NCT02921997|Biological|Monovalent influenza A/H7N9 virus vaccine|Monovalent influenza A/H7N9 virus vaccine.
15995780|NCT02921984|Drug|Docetaxel|Docetaxel only: 80 mg/m2 on day one, every 21 days if
15995781|NCT02921984|Radiation|Intensity-modulated radiotherapy|a total dose of 60-66Gy in 30-32 fractions over 6-7 weeks
15995782|NCT02921984|Drug|Pemetrexed|Pemetrexed only: 500 mg/m2 on day one, every 21 days
15995783|NCT02921984|Drug|Cisplatin|Cisplatin only: 70 mg/m2 on day one to day three, every 21 days
15995784|NCT02921971|Drug|SAR156597 (ACT14604)|Pharmaceutical form:Solution Route of administration: Subcutaneous
15995785|NCT02921971|Drug|Placebo|Pharmaceutical form:Solution Route of administration: Subcutaneous
15995786|NCT02921958|Behavioral|occupational therapy|Family-centered occupational therapy services
15995787|NCT02921945|Biological|SCT800|recombinant human coagulation factor VIII
15995788|NCT02921932|Dietary Supplement|Ensure, Resource 2.0 and Glucerna|Preoperative nutritional supplement for undernourished patients
15995789|NCT02921932|Other|Cognitive Training, Memory Card Game|Preoperative memory card game
15995790|NCT02921932|Device|'Threshold' Inspiratory Muscle Trainer, Respironics of New Jersey Inc|Inspiratory muscle trainer protocol for strengthening respiratory muscles
15995791|NCT02921919|Drug|Talazoparib|Maximum starting dose: 1mg/day or last tolerated dose in the originating protocol
15995792|NCT02921906|Other|High protein meal|Breakfast with high protein / low carbohydrate content
15995793|NCT02921906|Other|High carbohydrate meal|Breakfast with high carbohydrate / low protein content
15995794|NCT02921906|Drug|Paracetamol|Standard dose of paracetamol administered with each meal to allow measurement of rate of gastric emptying.
15995795|NCT02921906|Other|Fasting state - sulphonylurea only|People with diabetes take sulphonylurea medication in the absence of any food stimulus
15995801|NCT02921880|Other|Cardiac Rehabilitation|
15995802|NCT02921867|Other|Simulation-based training|The simulation-based training will consist of nine modules that can be trained in random order and training periods within the eight weeks before clinical training starts.
15995803|NCT02921854|Other|Blood withdrawal|For each patient, 3 blood withdrawals of 25 ml each will take place during treatment
15995804|NCT02921841|Behavioral|D*STAR|
15995805|NCT02921841|Behavioral|D*HEALTH|Digital general health promotion intervention. Time and attention matched intervention that targets health behaviors relevant to youth including exercise, nutrition, sleep, and smoking. Basic information about HIV and sexuality is also included.
15995812|NCT02921776|Other|Aim 1 - VidaTalk - post-extubation|"Observation of task completion will be made while patients complete a series of messages using the VidaTalk app:
~Tell me you are tired
~Tell me you are having pain
~Rate this pain
~Tell me there is pain in your back
~Tell me your pain is sharp
~Ask to see the doctor
~Write your favorite color by drawing with your finger
~Type How are you? Patients will also complete a 1-item difficulty rating and a 3-item After-Scenario Questionnaire (ASQ) after each task.
~Patients will also be asked to (a) comment on the customization of the app and make suggestions; (b) rate the extent to which they would use the device if they were an ICU patient and unable to speak.
~Group 1 only:
~Patients will be asked about their preferences for customizing the VidaTalk app."
15995813|NCT02921776|Other|Aim 2 - VidaTalk - intubated|Usability testing prior to clinical trial. The company will have performed further iterative design assessments and engineered a Vidatalk tablet application prototype for a field-test for functionality (human-device interaction factors, feasibility, and usability) and acceptability. Data will be collected by a trained data collector as in Aim 1 with the addition of Ease of Communication and Frustration ratings before and after the testing sequence. To reduce burden, patients in this group will complete the 3-item ASQ one time after all tasks are completed. They will also complete a 13-item System Usability Scale (SUS).
15995814|NCT02921776|Device|Aim 3 - VidaTalk tablet app|Patients in the intervention group will receive a protocolized instruction in the use of the VidaTalk application and mounting of the device including patient return demonstration of key features, and review/ testing to competence conducted by a trained interventionist. When available, a family member may be included in surveys about the patients hospital stay, if patient agrees. The interventionist will visit patients briefly (5-10 minutes) each day to check user needs and concerns and will review or retrain on message options if needed.
15995815|NCT02921776|Other|Aim 3 - attention-control with non-VidaTalk tablet|Patents randomized to the control group will receive a protocolized introduction to the bedside Android device without the VidaTalk app, focusing instead on a common tablet application. Daily visits will be conducted with control group patients to query on use of the attention-control tablet.
15995816|NCT02921763|Drug|Dydrogesterone|
15995817|NCT02921750|Device|Exufiber Gelling Fibre Dressing|Gelling fibre dressing
15995818|NCT02921750|Device|Aquacel Extra Hydrofiber® Dressing with Strengthening Fibre|Hydrofiber® Dressing with Strengthening Fibre
15995819|NCT02921737|Drug|TAS-102|TAS-102 (35 mg/m2/dose) orally 2 times daily beginning the morning of Day 1 of each cycle and ending the evening of Day 5 of each cycle, as well as beginning the morning of Day 8 and ending the evening of Day 12 of each cycle. No TAS-102 will be given on Days 6-7 or Days 13-28 of each cycle.
15995862|NCT02921269|Drug|Atezolizumab|Given IV
15995863|NCT02921269|Biological|Bevacizumab|Given IV
15995864|NCT02921269|Other|Laboratory Biomarker Analysis|Correlative studies
15995820|NCT02921724|Device|TreC-Onco|"TreC-Onco is composed of two tools aimed at supporting patient self-care and health professional monitoring and intervention:
~Mobile diary app. This is an Android app (for Android version 2.2 and higher) that allows patients to record parameters related to their health state (e.g. medications; blood pressure, weight, fever; side-effects or other symptoms) through a mobile device. Data are stored in a central database and are made available in real time to health professionals through a web dashboard on the TreC server or through a tablet app.
~Web dashboard. Through this, oncologists can check patient data, monitoring their side-effects and adherence to prescriptions. The Dashboard is optimized for the Firefox browser in version 7 or higher."
15995821|NCT02921711|Device|LVIS®|Low-profile Visualized Intraluminal Support device
15995822|NCT02921698|Device|FRED®|Flow Re-Direction Endoluminal Device
15995823|NCT02921685|Drug|Monalizumab|Four dose levels will be tested.
15995824|NCT02921672|Other|Mediterranean Diet|Diet consisting of fruits, vegetables, grains, dairy, olive oils, seafood, and nuts. It is low in red meat and solid fats.
15995825|NCT02921659|Dietary Supplement|Niagen™|nicotinamide riboside chloride, 250mg capsules
15995826|NCT02921659|Dietary Supplement|Placebo|silicified microcrystalline cellulose, vegetarian capsule
15995827|NCT02921646|Other|Measure of resting energetic expenditure|measure of resting energetic expenditure
15995828|NCT02921633|Other|Intervention letter|
15995829|NCT02921620|Biological|PRX-102|Intravenous
15995830|NCT02921620|Other|Placebo|Intravenous
15995831|NCT02921607|Other|Observational group|Participants will be asked to complete a questionnaire prior to discharge and 3 months later to follow up
15995832|NCT02921594|Device|Total knee arthroplasty with Vanguard XP|
15995833|NCT02921594|Device|Total knee arthroplasty with Vanguard CR|
15995834|NCT02921581|Radiation|FDG-PET guided dose painting|
15995835|NCT02921568|Device|P200TE|Optical Coherence Tomography and Scanning Laser Ophthalmoscope device.
15995836|NCT02921568|Device|Spectral OCT/SLO|Optical Coherence Tomography and Scanning Laser Ophthalmoscope device.
15995837|NCT02921555|Drug|Methylprednisolone|Intravenous bolus of methylprednisolone 0.5g/day for 3 consecutive days followed by a decreasing conventional course of oral prednisone (week1; 60mg/d, w2; 50mg/d, w3;40mg/d, w4; 30mg/d, w5; 20mg/d, w6; 15mg/d, w7; 10mg/d, w8; 5 mg/d, w9; 0mg/d)
15995838|NCT02921555|Drug|Prednisone|Conventional course of oral prednisone (week1; 60mg/d, w2; 50mg/d, w3;40mg/d, w4; 30mg/d, w5; 20mg/d, w6; 15mg/d, w7; 10mg/d, w8; 5 mg/d, w9; 0mg/d)
15995839|NCT02921542|Device|Laser Atherectomy|The Turbo-Power is laser atherectomy catheter designed for treatment of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents with adjunctive percutaneous transluminal angioplasty (PTA).
15995840|NCT02921529|Other|TEAS|Electric stimulation was given through electrode attached to specific acupoints
15995841|NCT02921529|Other|false stimulation|Electrodes were attached to specific acupoints without electric current
15995842|NCT02921516|Behavioral|N'ap Grandi|Eight 90-minute adolescent cognitive behavioral modules and four 90-minute caregiver cognitive behavioral modules, delivered in weekend workshops over a 1 month period, with the last two modules for joint participation of adolescents and caregivers.
15995843|NCT02921516|Behavioral|N'ap Grandi - A|Eight 90-minute adolescent cognitive behavioral modules delivered in weekend workshops over a 1 month period.
15995844|NCT02921516|Behavioral|Health Promotion - A|Eight 90-minute adolescent health promotion modules delivered in weekend workshops over a 1 month period.
15995845|NCT02921503|Other|mobile topical corticosteroid app|app used on mobile phones that takes the input of providers and suggests topical corticosteroids with specific information on the ingredient, vehicle, and amount
15995846|NCT02921490|Device|FDG PET/MR examination.|All recruited patients will undergo an FDG PET examination focused on the lumbar spine.
15995847|NCT02921477|Drug|bosutinib|
15995848|NCT02921464|Other|none - registry clinic followup only|
15995849|NCT02921451|Device|Restorelle Smartmesh|Patients will have surgery using the device, Restorelle Smartmesh, for treatment of uterine prolapse.
15995850|NCT02921438|Device|VitalScan Magnetocardiograph|A passive, non-contact, mobile medical device that measures, displays, stores, and retrieves magnetic fluctuations caused by heart activity at a patient's bedside.
15995851|NCT02921425|Behavioral|patient health record|The study intervention involved the provision to study participants of targeted instruction and practice on use of two features of the Track Health (TH) function of the VA's patient health record (PHR) known as My HealthyVet (MHV) -- Journals and Vitals + Readings -- as a basis for promoting positive physical activity (PA) and dietary lifestyles. Seven interactive multimedia instructional modules were developed by the study team. These modules demonstrated on a computer screen how to enter PA and diet information into the Journals feature; how to add weight data into the Vitals + Readings feature; how to view these and other measures in tabular and graphical formats over different time frames; and the concept of possible cause-effect links between behavioral lifestyle and physiological outcome data. Participants were directed to enter food intake, PA, and weight information a specified number of times per week over the 3-month study period.
15995852|NCT02921412|Device|fanfilcon A|contact lens
15995853|NCT02921386|Drug|Oral Testosterone Undecanoate|All study participants received Oral TU dose of 237 mg TU twice daily before breakfast and dinner for 14 days and throughout 5 crossover periods
15995854|NCT02921373|Biological|19F Cell Sense-labeled PBMC|"Peripheral blood mononuclear cells (PBMC) will be isolated from patient whole blood samples and labeled in a GMP facility with GMP grade 19F Cell Sense imaging agent.
~These cells will be re-administered to the patient prior to imaging."
15995855|NCT02921373|Device|MRI|Participants will undergo Magnetic Resonance Imaging (MRI) at 1 hour and 24 hours following PBMC administration
15995856|NCT02921360|Drug|acetylsalicylic acid|
15995857|NCT02921347|Procedure|switching between invasive and noninvasive ventilation|As defined criteria, patients are switched between invasive and noninvasive ventilation until the ventilator is successfully weaned.
15995858|NCT02921334|Procedure|switching between invasive and noninvasive ventilation|As defined criteria, patients are switched between invasive and noninvasive ventilation until the ventilator is successfully weaned.
15995859|NCT02921295|Device|Sidekick Stubbies|
15995872|NCT02921230|Device|Peripheral stenting|stent implantation during the index procedure
15995873|NCT02921217|Dietary Supplement|Active Probiotic|Product 1: 200 mg maltodextrin and 100 mg of active Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) (1011 CFU/g),
15995874|NCT02921217|Dietary Supplement|Inactivated probiotic|Product 1: 200 mg maltodextrin and 100 mg of Bifidobacterium animalis subsp. lactis BPL1 (CECT 8145) inactivated by heat (1011 CFU/g),
15995875|NCT02921217|Dietary Supplement|Control|Placebo: 300 mg maltodextrin.
15995876|NCT02921204|Other|Vitamin D status|There is no intervention in this study
15995877|NCT02921191|Drug|filgrastim, TBO-filgrastim or pegfilgrastim|First cycle
15995878|NCT02921178|Other|Omalizumab|comparision of using Omalizumab and non-Omalizumab treatment
15995879|NCT02921165|Drug|analgesic mouth rinses (dissolved Aspirin)|Group 1 and Group 2 patients will be prescribed analgesic mouth rinses (dissolved Aspirin) twice daily along with the standard prescription of analgesics and antibiotics.
15995880|NCT02921165|Drug|Normal saline rinses.|Non Hypertensive patients will be prescribed normal saline rinses twice daily along with the standard prescription of analgesics and antibiotics.
15995881|NCT02921152|Procedure|bone marrow aspiration /trephine biopsy|
15995882|NCT02921139|Radiation|Stereotactic ablative radiotherapy (SABR)|Patients with HCC after incomplete TACE are randomized to stereotactic ablative radiotherapy (SABR). SABR will be delivered in 5 fractions.The preferred inter-fraction time interval is 48 hours. The entire treatment with 10 days is preferred.
15995883|NCT02921139|Procedure|Re-Transcatheter arterial chemoembolization (re-TACE)|Patients with HCC after incomplete TACE are randomized to further re-TACE.
15995884|NCT02921100|Procedure|cytology|The conventional cytology was interpreted independently by two cytopathologists, both of whom are blinded to the DIA results. The conventional cytologic diagnosis were classified as no abnormal cells, atypical cells, suspicious malignant cells and malignant cells.
15995885|NCT02921100|Procedure|DNA ploidy|DIA is a form of cytologic analysis that quantifies cellular constituents by using spectro photometric principles and a sister technique to flow cytometry.Quantification of DNA content, chromatin distribution, and nuclear morphology can be determined and suggest features of malignancy
15995886|NCT02921100|Procedure|EUS-FNA|All the enrolled participants underwent an operation of EUS-guided fine needle aspiration. Histological and cytological samples were obtained following this step.
15995887|NCT02921100|Device|EUS-guided fine needle|
15995888|NCT02921087|Device|Test Daily Disposable Soft Contact Lenses|Worn daily for 7 +/- 2 days
15995889|NCT02921087|Device|Control Daily Disposable Soft Contact Lenses|Worn daily for 7 +/- 2 days
15995890|NCT02921074|Other|Computerized Plasticity-Based Adaptive Cognitive Training|
15995891|NCT02921074|Other|Commercially available computerized training|
15995892|NCT02921061|Drug|Cladribine|Given IV
15995893|NCT02921061|Drug|Cytarabine|Given IV
15995894|NCT02921061|Drug|Decitabine|Given IV
15995895|NCT02921061|Biological|Filgrastim|Given SC
15995896|NCT02921061|Other|Laboratory Biomarker Analysis|Correlative studies
15995897|NCT02921061|Drug|Mitoxantrone Hydrochloride|Given IV
15995898|NCT02921048|Dietary Supplement|omega-3 fatty acids|
15995899|NCT02921035|Drug|Rebif (Interferon beta-1a)|Rebif will be administered at a dose of 44 mcg, sc, tiw.
15995900|NCT02921022|Drug|Gemcitabine|
15995901|NCT02921022|Drug|Nab-paclitaxel|
15995902|NCT02921022|Drug|PEGPH20|
15995903|NCT02921009|Device|Crosslinking using UV light of two different fluence rates|The treatment of keratoconus involves the application of riboflavin followed by Ultraviolet light of differing intensities. This study will determine the effectiveness of a greater UV light fluence at a shorter treatment time than is currently utilized.
15995904|NCT02920996|Drug|Merestinib|Oral, predetermined dosage per protocol, once daily per 28 day treatment cycle
15995905|NCT02920983|Device|somofilcon A|contact lens
15995906|NCT02920983|Device|nelfilcon A II 2|contact lens
15995907|NCT02920983|Device|omafilcon A ll 2|contact lens
15995908|NCT02920970|Device|narafilcon A|contact lens
15995909|NCT02920970|Device|stenfilcon A|contact lens
15995910|NCT02920957|Device|comfilcon A|contact lens
15995911|NCT02920957|Device|senofilcon C|contact lens
15995912|NCT02920944|Device|EUS-FNB with 20 gauge ProCore needle|EUS-FNB with 20-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)
15995913|NCT02920944|Device|EUS-FNB with 22 gauge ProCore needle|EUS-FNB with 22-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)
15995914|NCT02920931|Drug|Tenofovir disoproxil|
15995915|NCT02920918|Drug|Canagliflozin|
15995916|NCT02920918|Drug|Sitagliptin|
15995917|NCT02920905|Drug|Lidocaine|"Two intravenous cannulae will be placed; one in a vein on the dorsum of the hand to be operated (22 gauge) and the other in the opposite hand. A double tourniquet will be positioned on the upper arm of the hand to be operated. Arm will be elevated for 2 min.
~Circulatory isolation of arm will be confirmed by inspection of the color of the limb, absence of radial pulse and loss of pulse oximetry tracing in the ipsilateral index finger. The upper (proximal) tourniquet will then be inflated to a pressure of 100 mmHg above the systolic blood pressure of the patient. The anesthetic solution will be prepared by an observer and will be given over a period of 90 seconds."
15995918|NCT02920905|Drug|atracurium|"Two intravenous cannulae will be placed; one in a vein on the dorsum of the hand to be operated (22 gauge) and the other in the opposite hand. A double tourniquet will be positioned on the upper arm of the hand to be operated. Arm will be elevated for 2 min.
~Circulatory isolation of arm will be confirmed by inspection of the color of the limb, absence of radial pulse and loss of pulse oximetry tracing in the ipsilateral index finger. The upper (proximal) tourniquet will then be inflated to a pressure of 100 mmHg above the systolic blood pressure of the patient. The anesthetic solution will be prepared by an observer and will be given over a period of 90 seconds."
16038334|NCT02607657|Drug|Eplerenone 50 mg|
15995919|NCT02920905|Drug|Mg sulphate|"Two intravenous cannulae will be placed; one in a vein on the dorsum of the hand to be operated (22 gauge) and the other in the opposite hand. A double tourniquet will be positioned on the upper arm of the hand to be operated. Arm will be elevated for 2 min.
~Circulatory isolation of arm will be confirmed by inspection of the color of the limb, absence of radial pulse . The upper (proximal) tourniquet will then be inflated to a pressure of 100 mmHg above the systolic blood pressure of the patient. The anesthetic solution will be prepared by an observer and will be given over a period of 90 seconds."
15995920|NCT02920892|Drug|AFQ056|Oral suspension (liquid)
15995921|NCT02920892|Other|Placebo|Oral suspension (liquid)
15995922|NCT02920892|Other|Language Intervention|The language intervention will be administered by a trained language specialist through a combination of in clinic visits and at home synchronous video conferencing sessions. The intervention will subsequently be delivered to the parent by a speech-language clinician through weekly clinician coaching, homework, and feedback sessions.
15995923|NCT02920879|Procedure|PEEP-level, driving pressure|Different levels of PEEP and different levels of driving pressures during mask-ventilation at anesthesia induction.
15995926|NCT02920853|Behavioral|Biofeedback Training (BT-CPR)|Participants will receive biofeedback training (which will include electric stimulations) to reduce arousal and pain
15995927|NCT02920853|Behavioral|Biofeedback Training|Participants will receive biofeedback training to reduce arousal and pain
15995928|NCT02920840|Device|Intermittent theta-burst stimulation|see associated arm/group description
15995929|NCT02920840|Device|Negative-peak-triggered-TMS|see associated arm/group description
15995930|NCT02920840|Device|Open-loop replay TMS|see associated arm/group description
15995931|NCT02920827|Combination Product|Dapivirine Vaginal Ring|A platinum-catalysed silicone elastomer matrix vaginal ring containing 25mg of dapivirine used over 28 days
15995932|NCT02920827|Combination Product|Placebo vaginal ring|Placebo vaginal ring containing no dapivirine
15995933|NCT02920814|Other|Cognitive Behavioural Therapy|Time intensive CBT over 8 weeks, including 6 weekly sessions and two intensive days of 4 hours each.
15995934|NCT02920801|Drug|saxagliptin|5mg per day for 12 weeks
15995935|NCT02920801|Drug|Metformin|1500mg per day for 12 weeks
15995936|NCT02920788|Behavioral|Goal-Oriented Attentional Self-Regulation (GOALS)|GOALS is a manualized, therapist-administered cognitive training program that targets executive control functions of applied mindfulness-based attention regulation and goal management strategies and links them to participant-defined real-life goals. In contrast to training via practice on isolated tasks, this training protocol involves application of attention regulation skills and strategies to participant-defined goals in real life, ecologically valid settings. One of the main training aims is to improve self-regulatory control mechanisms as they contribute to goal attainment.
15995937|NCT02920788|Other|Brain Health Education (BHE)|BHE group is a formal in-person, active, psycho-educational, control intervention closely matched to GOALS for length, intensity, and contact with a therapist/facilitator. Topics include brain structure, function, sleep, stress, emotion and the brain.
15995938|NCT02920788|Device|fMRI|Functional Magnetic Resonance Imaging of the Brain
15995939|NCT02920775|Other|Non-interventional study - retrospective database review|
15995940|NCT02920762|Other|on-interventional study - retrospective database review|
15995941|NCT02920749|Drug|Sevoflurane group A|In this group anaesthesia was maintained with sevoflurane. Initial and maintenance fresh gas flow was 4 and 1 l/min, respectively. Sevoflurane dosing was adjusted for the same MAP range.
15995942|NCT02920749|Drug|Sevoflurane group B|In this group anaesthesia was maintained with sevoflurane. Initial and maintenance fresh gas flow was 4 and 1 l/min, respectively. Sevoflurane dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg.
15995943|NCT02920749|Drug|Propofol group C|In this group anaesthesia was maintained with propofol. Propofol was administered according to protocol. Propofol dosing was adjusted for the same MAP range.
15995944|NCT02920749|Drug|Propofol group D|In this group anaesthesia was maintained with propofol. Propofol dosing was set to maintain target BIS levels of 40 to 60 and MAP for controlled hypotension within 60-85 mmHg.
15995945|NCT02920723|Other|Training|
15995946|NCT02920723|Other|Control|
15995947|NCT02920710|Drug|Repository Corticotropin Injection|"Initial treatment with 80 units daily for ten days (induction phase)
~Maintenance treatment with 80 units twice weekly (maintenance phase)"
15995948|NCT02920697|Drug|S 55746|S 55746, per os administration, from 50 to 1500 mg, once a day during a 21-day cycle. Participants will receive 21-day cycles of treatment until a discontinuation criterion is met.
15995949|NCT02920684|Other|Passive legs mobilisation|A physiotherapist performs a passive leg movement
15995950|NCT02920684|Other|Passive cycloergometer|A motorised cycloergometer performs a passive cycling
15995951|NCT02920684|Other|Muscular electrical stimulation|A neuromuscular electrical stimulation device performs a quadriceps located stimulation
15995952|NCT02920684|Other|FES cycling|A motorised cycloergometer performs a passive cycling with quadriceps neuromuscular stimulation
15995953|NCT02920671|Other|Tracer-enhanced oral glucose tolerance test (OGTT*)|Oral glucose tolerance test with stable isotope tracers will be administered. Resting energy expenditure and respiratory quotient will be evaluated during this test using indirect calorimetry.
15995954|NCT02920671|Other|Muscle MRI|Non-invasive muscle MRI will be performed to evaluated metabolic capacity.
15995955|NCT02920671|Other|Dual energy x-ray absorptiometry (DXA)|DXA will be performed to evaluate body composition.
15995956|NCT02920671|Other|Questionnaires|Questionnaires will be used to evaluate participants' health and habits.
15995957|NCT02920658|Drug|NAVS Naphthalan|
15995958|NCT02920658|Drug|0.05% Betamethasone dipropionate|
15995959|NCT02920645|Other|AVM-related ICH|
15995960|NCT02920632|Behavioral|Online cognitive training 1|Eight-week online cognitive training program, three times a week for 45 minutes. The training contains several games that are designed to train cognitive functions.
15995961|NCT02920632|Behavioral|Online cognitive training 2|Eight-week online active comparator program, three times a week for 45 minutes. The training contains several games.
15995962|NCT02920619|Device|Ultrasound|Imaging of the rectus femoris, lower-trapezius, brachioradialis, tibialis anterior, middle deltoid, and pectoralis major will be conducted in Veteran participants during a single visit to the Washington D.C. Veterans Affairs Medical Center. Imaging will be conducted by investigators experienced with quantitative ultrasound using diagnostic musculoskeletal B-mode ultrasound with a 10 Mhz linear transducer.
15995963|NCT02920606|Procedure|Pulpotomy|
15995964|NCT02920606|Procedure|Endodontic treatment|
15995965|NCT02920593|Drug|Vitamin D3|Vitamin D prophylaxis
15995966|NCT02920580|Procedure|Extubation|This is an extubation by removal of endotracheal tube which must be done on the day of randomization or the following day. Any decision to subsequently reintubate the patient will be left to the discretion of the clinical team. Similarly, if a tracheostomy is deemed necessary in a patient who fails the extubation attempt, this will be managed at the discretion of the treating team. If for any reason the patient is not extubated according to the randomized schedule, the reason(s) will be recorded on a protocol violation form and the site investigator will be notified. If a patient receives a tracheostomy instead of being extubated we will again record reasons for this, but the patient will be analysed in the extubation group according to the intention-to-treat principle.
15995967|NCT02920580|Procedure|Usual Care|Patients in this group will be treated according to usual care, which may include extubation (removal of endotracheal tube) or insertion of a tracheostomy, timed according to physicians' discretion. The inclusion of this arm will allow prompt extubation to be compared to usual practice, which often involves further observation and delayed decision-making due to clinician uncertainty about the optimal airway management strategy. Incorporation of usual care arms has been promoted as a design feature to improve the safety and interpretability of critical care clinical trials.
15995968|NCT02920567|Drug|Octreotide|After pancreatoduodenectomy, octreotide was injected to patients every 8 hours subcutaneously for 7 days
15995969|NCT02920567|Drug|Placebo|After pancreatoduodenectomy, normal saline was injected to patients every 8 hours subcutaneously for 7 days
15995970|NCT02920554|Procedure|wedge resection|The extent of hepatic resection is wedge resection of liver including gallbladder fossa
15995971|NCT02920554|Procedure|bisegmentectomy|The extent of hepatic resection is 4b/5 bisegmentectomy of liver
15995972|NCT02920541|Drug|S 055746|S 055746, per os administration, from 50 to 2000 mg once a day during a 21-day cycle. Participants will receive 21-day cycles of treatment until a discontinuation criterion is met.
15995973|NCT02920528|Drug|Ketamine|sub-dissociative ketamine
15995974|NCT02920528|Drug|Placebo|Normal Saline
15995975|NCT02920515|Drug|Triptorlin or Leuprorelin|Gonadotrophin releasing hormone agonists (GnRHa)
15995976|NCT02920515|Drug|Zhibo dihuang pills|Traditional Chinese Medicine
15995977|NCT02920515|Drug|Dabu ying pills|Traditional Chinese Medicine
15995978|NCT02920502|Dietary Supplement|Arm 2: cholecalciferol 50,000 IU|One time dose of cholecalciferol 50,000 IU
15995979|NCT02920502|Dietary Supplement|Arm 3: cholecalciferol 100,000 IU|One time dose of cholecalciferol 100,000 IU
15995980|NCT02920502|Dietary Supplement|Arm 4: cholecalciferol 200,000 IU|One time dose of cholecalciferol 200,000 IU
15995981|NCT02920502|Other|Arm 1: Placebo|One time dose of Placebo
15995982|NCT02920489|Drug|Individualized epidural analgesia|Epidural analgesia will begin when asked by the parturients (during the first stage of labor) and the numeric rating scale is 5 or higher. Analgesia will be terminated at the end of the third stage of labor.
15995983|NCT02920489|Drug|Routine epidural analgesia|Epidural analgesia will begin when asked by the parturients (during the first stage of labor) and the cervix is dilated to 1 cm or more. Analgesia will be terminated at the end of the third stage of labor.
15995984|NCT02920476|Drug|TAS-102|"Days 1 through 5: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 1 of each cycle and the last dose administered in the evening of Day 5. TAS-102 is to be taken within 1 hour of completion of morning and evening meals.
~Days 6 through 7: Rest
~Days 8 through 12: TAS-102 (35 mg/m2/dose) orally 2 times daily with the first dose administered in the morning of Day 8 of each cycle and the last dose administered in the evening of Day 12.
~Days 13 through 28: Rest"
15995985|NCT02920450|Drug|Gedatolisib|"During the first phase, subjects will be sequentially enrolled to each increasing dose level, beginning with dose level 1 (110 mg) until the first dose limiting toxicity occurs, or safely accrued to dose level 3. PF-05212384 is intravenously infused over a thirty minute period. The dose given in the phase 2 portion will be the MTD determined in the phase Ib portion of the study.
~Dose Level 1: 110 mg Dose Level 2: 150 mg Dose Level 3: 180 mg"
15995986|NCT02920450|Drug|Paclitaxel|Given as 200 mg/m2 infusion over a three hour period at every twenty-one days; the dose will not adjust as part of the study design.
15996035|NCT02920060|Drug|Intravenous levetiracetam|intravenous levetiracetam(30mg/kg bolus followed by 20mg/kg/dose IV 12 hourly).
15996074|NCT02919787|Drug|Oxaliplatine|Adjuvant treatment
15995987|NCT02920450|Drug|Carboplatin|The carboplatin dose (mg) = AUC x (CrCl + 25) where AUC = 6 depending on the dose level. carboplatin is intravenously infused over a thirty minute period following paclitaxel administration; the dose will not adjust as part of the study design.
15995988|NCT02920437|Behavioral|Four-week weekly intervention to reduce salt intake|The intervention group will receive a four-week weekly intervention, about 15 minutes each. Two sessions will be face-to-face and two sessions will be on the phone. The participants will be informed of their 24-hour urinary sodium excretion at each measurement time once available.
15995989|NCT02920437|Other|Usual government pamphlets|The control group will receive usual government pamphlets when they know their 24-hour urinary sodium excretion at baseline. However, they will not be informed of their follow-up urinary sodium excretion results immediately.
15995990|NCT02920424|Drug|JNJ-56022473|Subjects will be administered with JNJ-56022473 SC depending upon on the dose levels.
15995991|NCT02920424|Drug|Placebo|Subjects will receive matching placebo.
15995992|NCT02920411|Other|Pediatopic Treatment Cream|Applied twice a day minimum.
15995993|NCT02920411|Other|Pediatopic Body lotion|Applied at libitum.
15995994|NCT02920398|Drug|turoctocog alfa pegol|Administered as intravenous injections at a dose of 50 U/kg. Patients will receive each product in a randomised cross-over design for comparison of the pharmacokinetics between turoctocog alfa pegol from the pivotal process and turoctocog alfa pegol from the commercial process.
15995995|NCT02920385|Drug|Semaglutide|Oral administration once daily alone or together with levothyroxine or Placebo
15995996|NCT02920385|Drug|SNAC|Oral administration once daily alone or together with levothyroxine or semaglutide
15995997|NCT02920385|Drug|Levothyroxine|Oral administration alone or together with SNAC or oral semaglutide
15995998|NCT02920385|Drug|Placebo|Oral administration once daily together with semaglutide
15995999|NCT02920372|Drug|EPOETIN ALFA|
15996000|NCT02920359|Drug|LEUPRORELIN ACETATE|
15996001|NCT02920333|Procedure|conventional rehab training|Conventional rehab training will be conducted daily for 10 days, after NIBS intervention.
15996002|NCT02920333|Device|tDCS|tDCS will be applied 10 days, followed by conventional rehab training. Stimulation will be conducted at the intensity of 2 mA and last for 20 minutes. anode will be placed over the affected primary motor cortex (M1) of cortical representation of the tibialis anterior muscle (TA), while the cathode will be used as reference electrode and placed over the forehead of the unaffected side.
15996003|NCT02920333|Device|rTMS|rTMS will be applied 10 days, followed by conventional rehab training. Subjects will receive 10 Hz rTMS, and a total of 1200 pulses will be delivered for one treatment session.
15996004|NCT02920333|Device|sham tDCS|The same stimulation parameters as tDCS treatment will be employed for the sham stimulation. However, the current will be applied for 30 seconds only, to give subjects the sensation of the stimulation.
15996005|NCT02920320|Other|Internet-based self-help program|
15996006|NCT02920307|Procedure|TEP without fixation|Standard totally extraperitoneal preperitoneal (TEP) inguinal hernia repair
15996007|NCT02920307|Procedure|TEP with fixation|Standard totally extraperitoneal preperitoneal (TEP) inguinal hernia repair
15996008|NCT02920307|Procedure|TAPP without fixation|Standard transabdominal preperitoneal (TAPP) inguinal hernia repair without mesh fixation
15996009|NCT02920307|Procedure|TAPP with fixation|Standard transabdominal preperitoneal (TAPP) inguinal hernia repair
15996010|NCT02920294|Dietary Supplement|Probiotic 1|Fresh fermented dairy drink containing yoghurt ferments
15996011|NCT02920294|Dietary Supplement|Probiotic 2|Fresh fermented dairy drink containing probiotic strain
15996012|NCT02920294|Dietary Supplement|Placebo|Acidified dairy drink without ferments
15996013|NCT02920281|Other|Polysomnography|
15996014|NCT02920268|Other|Dance and yoga intervention|
15996015|NCT02920255|Other|Diagnostic|Measurement of spinal tilt
15996016|NCT02920242|Drug|Rifaximin (Sandoz GmbH) tablet|200 mg tablet administered orally.
15996017|NCT02920242|Drug|Rifaximin (Xifaxan)|200 mg tablet administered orally
15996018|NCT02920242|Drug|Placebo|Matching Placebo tablet administered orally
15996019|NCT02920229|Drug|68Ga- PSMA|100-200 MBq of 68Ga-PSMA will be injected intravenously prior to perform the PET/CT
15996020|NCT02920216|Drug|indocyanine green|intravenous injection of Indocyanine Green (0,25mg/kg) before surgery.
15996021|NCT02920203|Genetic|Heart and spleen tissue|genetic sequencing
15996022|NCT02920190|Drug|Liraglutide|1.8 mg Liraglutide administered subcutaneously once daily for 12 consecutive months
15996023|NCT02920177|Drug|platelet-rich plasma injection|platelet-rich plasma injection
15996024|NCT02920177|Drug|Kenalog 10 MG/ML Injectable Suspension|4 mL corticosteroid injection
15996025|NCT02920164|Device|Auricular acupuncture|Auricular acupuncture with indwelling permanent needles
15996026|NCT02920164|Device|Placebo acupuncture|Placebo acupuncture with placebo needles
15996027|NCT02920151|Other|balance exercises circuit|Thirteen workstations were organized in a circuit format on involved multidirectional gait in different bases of support, unstable surfaces, functional reach, exercise with balls, and single-leg stance
15996028|NCT02920125|Drug|SUVED|Ayurvedic formulation in ghana (concentrated) in capsules; 500 mg each
15996029|NCT02920125|Combination Product|REIMMUGEN|Whole Cow colostrum in powder put in capsules; 300mg each
15996030|NCT02920125|Other|Grain flour placebo|Grain flour in capsules. Jowari flour in dummy Reimmugen and Ragi flour in dummy Suved placebos
15996031|NCT02920112|Behavioral|Telephone based Cognitive Behavioral Therapy|6 sessions of Telephone based Cognitive Behavioral Therapy over the telephone, lasting approximately 60 minutes each.
15996032|NCT02920099|Other|Nutrition Literacy Assessment Instrument (NLAI)|Assessment tool which combines elements of different nutrition literacy tools.
15996033|NCT02920086|Behavioral|Nutrition Education Program|"The OPTimal nutrition by Informing and Capacitating family members of best practices (OPTICS) intervention
~Nutritional education will be provided to ICU patents' families by a dietitian
~Tracking of nutritional information by family
~Encouragement for families to advocate for two or more Oral Nutritional Supplements per day for the patients (approximately 400 kcal/day)"
15996034|NCT02920086|Other|Decision Support Program|"Families will be provided with a web-based decision support tool (My ICU Guide)
~Families will meet with the ICU medical team early in ICU stay to review goals of care"
15996036|NCT02920060|Drug|Sodium valproate|intravenous sodium valproate(20mg/kg bolus followed by 10 mg/kg/dose IV 8hrly)
15996037|NCT02920047|Drug|Fimasartan/Amlodipine|Treatment B
15996038|NCT02920047|Drug|Fimasartan + Amlodipine|Treatment A
15996039|NCT02920034|Device|Radiofrequency denervation of the main renal arteries|Catheter based renal sympathetic denervation of the main renal arteries using the Spyral™ Catheter (Medtronic, MN, USA)
15996040|NCT02920034|Device|Radiofrequency denervation of renal arteries and branches|Catheter based renal sympathetic denervation of the main renal arteries and its branches using the Spyral™ Catheter (Medtronic, MN, USA)
15996041|NCT02920034|Device|Ultrasound denervation of the main renal arteries|Catheter based renal sympathetic denervation of the main renal arteries using the Paradise™ Catheter (ReCor Medical, CA, USA)
15996042|NCT02920021|Drug|ANB020|ANB020
15996043|NCT02920021|Drug|Placebo|Placebo
15996044|NCT02920008|Drug|guadecitabine|In Cycle 1, guadecitabine will be given for 10 days on Days 1-5 and Days 8-12. In Cycle 2, the guadecitabine dose will be 60 mg/m2 for either 10 days (Days 1-5 and 8-12) or 5 days (Days 1-5 only) based on assessment of disease response, and hematological recovery by Day ≥28.
15996045|NCT02920008|Drug|Treatment Choice (TC)|"High intensity: Intermediate or high dose cytarabine (HiDAC).
~Low intensity:
~LDAC.
~Decitabine.
~Azacitidine.
~Best supportive care only: given according to standard and institutional practice."
15996046|NCT02919995|Drug|RPL554|RPL554 suspension administered using a nebuliser
15996047|NCT02919995|Drug|Placebo|Placebo solution administered using a nebuliser
15996048|NCT02919969|Drug|Pembrolizumab|Pembrolizumab 200 mg will be administered as a 30 minute IV infusion every 3 weeks.
15996049|NCT02919956|Other|Magnetic Resonance Imaging|An MRI scan takes pictures of the brain and heart using a magnet and radio waves. During scanning, measurements of oxygen delivery to the brain will be obtained (CMRO2) as well as evaluation of the heart as it relates to the brain. During the scan patients will be monitored for safety by ECG, blood pressure, television camera, pulse oximetry, and carbon dioxide measurements. Cardiac anesthesiologist and cardiologist will be present.
15996050|NCT02919956|Other|Neurodevelopmental Testing|Quantitative ND tests and standardized rating scales will be used in the areas of intellectual, adaptive, visual motor skills, academic achievement in math and reading, attention and executive functioning , motor skills, memory, language, social skills and behavior. Neurodevelopmental Testing will last approximately 3.5-4 hours. Testing will be done through the Neurobehavioral Core at CHOP. Breaks will be taken as needed and a one hour lunch break will be taken, if applicable. ND testing will be performed prior to MRI (if on the same day) or on a different day than the MRI to promote engagement and best performance.
15996051|NCT02919943|Procedure|Percutaneous Coronary Intervention|OCT-guided Percutaneous Coronary Intervention.
15996052|NCT02919930|Device|Switch from oronasal to nasal mask during ASV treatment|One night of ASV treatment with oronasal mask followed by one night of ASV treatment with nasal mask.
15996053|NCT02919930|Device|Switch from nasal to oronasal mask during ASV treatment|One night of ASV treatment with nasal mask followed by one night of ASV treatment with oronasal mask.
15996054|NCT02919917|Drug|Midodrine Hydrochloride|Level 1: Compression stockings, abdominal binder Level 2: Midodrine 5mg 2x/d Level 3: Midodrine 10mg 2x/d Level 4: Midodrine 15mg 2x/d Level 5: Midodrine 20mg 2x/d Level 6 Midodrine 20mg 2x/d and Fludrocortisone 0.1mg 2x/d Level 7 Midodrine 20mg 2x/d and Fludrocortisone 0.2mg 2x/d
15996055|NCT02919917|Drug|Midodrine Hydrochloride|Level 1: Compression stockings, abdominal binder Level 2: Midodrine 5mg 2x/d Level 3: Midodrine 10mg 2x/d Level 4: Midodrine 15mg 2x/d Level 5: Midodrine 20mg 2x/d Level 6 Midodrine 20mg 2x/d and Fludrocortisone 0.1mg 2x/d Level 7 Midodrine 20mg 2x/d and Fludrocortisone 0.2mg 2x/d
15996056|NCT02919904|Device|ARESTM|"The ARESTM device is a commercial home sleep-testing device that can record the following parameters (for up to 7 continuous hours) when participants are asleep:
~NREM and REM sleep frequency and duration
~Duration and number of arousal
~Blood oxygen saturation and pulse rate via a silicone-embedded optical sensor
~Fluctuation in nasal airflow pressure via a nasal cannula and pressure transducer
~Head movement actigraphy and flux in snoring as measures of sleep/wake patterns via two accelerometers and an acoustic microphone
~Apnea/hypopnea index and respiratory disturbance index"
15996057|NCT02919891|Other|Questionnaire|Questionnaires
15996058|NCT02919878|Drug|Gemcitabine|Nucleoside analog- Chemotherapy
15996059|NCT02919878|Radiation|XRT|pre-operative radiotherapy given concurrently with Gemcitabine chemotherapy
15996060|NCT02919878|Drug|capecitabine|Capecitabine is given post operatively as adjuvant chemotherapy for 6 cycles. Each cycle consist of 2500 mg/m2 per day given orally from D1-14
15996061|NCT02919865|Device|MR perfusion imaging|"MR perfusion imaging will be performed in addition to the routine neuronavigational sequence obtained from re-operative/therapy planning.
~Following MR examination, patient may undergo a surgical biopsy or excision as determined clinically by the neurosurgeon.
~All patients, including those who do not go to surgery, will undergo clinical follow-up and imaging follow-up with perfusion imaging. This will allow for assessment of lesion progression over time, yielding valuable diagnostic information in differentiating radiation necrosis from tumour recurrence, particularly in those patients who do not undergo surgery."
15996062|NCT02919852|Procedure|laparoscopic retrovesical colpopectinopexia|Laparoscopic correction of pelvic organ prolapse using a mesh in retrovesical space with pectineal ligament fixation.
15996063|NCT02919839|Other|non-Interventional|
15996064|NCT02919826|Behavioral|Adapted Dialectical Behaviour Therapy|12 weekly sessions of DBT group therapy
15996065|NCT02919813|Behavioral|Mindfulness Based Group Cognitive BehaviorTherapy|Mindfulness Based Group Cognitive Behavior Therapy is a type of counseling that teaches women to have more control over their pain.
15996066|NCT02919813|Behavioral|Educational Seminars|Educational seminars teach women about the different aspects of PLV that affect emotional and physical health.
15996067|NCT02919800|Biological|MOD-5014|MOD-5014, a long-acting modified recombinant Factor VIIa
15996068|NCT02919800|Other|MOD-5014 Placebo|Placebo solution for SC injection containing the same inactive ingredients used in the active drug product at matching volumes
15996069|NCT02919787|Drug|5-FU|Neoadjuvant treatment
15996070|NCT02919787|Drug|Oxaliplatine|Neoadjuvant treatment
15996071|NCT02919787|Drug|Irinotecan|Neoadjuvant treatment
15996072|NCT02919787|Procedure|Pancreatic surgery|All patients
15996075|NCT02919787|Drug|Irinotecan|Adjuvant treatment
15996076|NCT02919774|Drug|POMA|"Pomaglumetad (POMA) is a mGluR 2/3 partial agonist"
15996077|NCT02919774|Drug|placebo|matching placebo tablets
15996078|NCT02919761|Drug|Acthar Gel|80 Units Acthar Gel per 1 mL for subcutaneous injection
15996079|NCT02919761|Drug|Placebo|Matching placebo 1 mL for subcutaneous injection
15996080|NCT02919748|Other|Choral Singing|Weekly sessions at 1 hour of choral singing.
15996081|NCT02919748|Other|Health Education Program|Weekly session at 1 hour of health education talk and group activities
15996082|NCT02919735|Drug|CG 428 cutaneous solution|The patient will spray treatment 10 times directly to the scalp area, with the cannula, and then gently massage the whole scalp with fingertips, twice a day, spaced out by minimum 4 hours
15996083|NCT02919735|Drug|Placebo cutaneous solution|The patient will spray treatment 10 times directly to the scalp area, with the cannula, and then gently massage the whole scalp with fingertips, twice a day, spaced out by minimum 4 hours
15996084|NCT02919722|Behavioral|Music Therapy|The majority of each study session will be spent engaging in music therapy: playing live music with a music therapist with the help of an occupational therapist. At the beginning and end of each session subjects will complete 2 assessments.
15996085|NCT02919709|Biological|blood taking|
15996086|NCT02919696|Drug|Abemaciclib|Administered orally
15996087|NCT02919683|Drug|Nivolumab|
15996088|NCT02919683|Drug|Ipilimumab|
15996089|NCT02919683|Procedure|Standard of Care Surgery|
15996090|NCT02919670|Dietary Supplement|Enterade|
15996091|NCT02919670|Dietary Supplement|Placebo|
15996092|NCT02919670|Other|Standard Supportive Care|
15996093|NCT02919657|Dietary Supplement|Genepro Protein|weekly blood draws to measure blood protein levels
15996094|NCT02919657|Dietary Supplement|Whey Protein|weekly blood draws to measure blood protein levels
15996095|NCT02919644|Biological|autologous dendritic cells loaded with autologous tumour homogenate|Each vaccine dose consists of 10_7 autologous dendritic cells loaded with autologous tumor homogenate
15996096|NCT02919644|Drug|IL2|Each vaccine dose is followed, after two days, by IL-2 as adjuvant, at a dose of 3 MU daily for five consecutive days
15996097|NCT02919631|Drug|Triheptanoin|Anaplerotic dietary oil
15996098|NCT02919631|Drug|Placebo oil|Safflower oil
15996099|NCT02919618|Radiation|stereotactic body radiotherapy (SBRT)|(Cardiac ablative radiotherapy)
15996100|NCT02919605|Drug|Single dose of Pentamidine|The patients will come to the hospital to take a single dose of the Pentamidine.
15996101|NCT02919605|Drug|Two doses of Pentamidine|The patients will come to the hospital to take two doses of the Pentamidine, in interval of one week between them.
15996102|NCT02919605|Drug|Three doses of Pentamidine|The patients will come to the hospital to take three doses of the Pentamidine, in interval of one week between them.
15996103|NCT02919592|Device|MemoryShape® Breast Implants|MENTOR® MemoryShape™ Breast Implants are devices with shells constructed from medical grade silicone elastomer. The shell is filled with Mentor's proprietary formulation of medical grade silicone gel. The textured shell is constructed of successive crosslinked layers of silicone elastomer, and includes raised orientation marks on the anterior and posterior of the implant intended to help the physician orient the implant and ensure proper placement during implantation. Each MENTOR® MemoryShape™ Breast Implant is provided sterile. MemoryShape Breast Implants are available in sizes ranging from 120 cc-775 cc and 5 styles with various projection and height options.
15996104|NCT02919592|Device|MemoryGel® Breast Implants|MENTOR® MemoryGel™ Breast Implants are round devices with shells constructed from medical grade silicone elastomer. The shell is filled with MemoryGel™, Mentor's proprietary formulation of medical grade silicone gel, and is constructed of successive cross-linked layers of silicone elastomer. There are two styles of shell: smooth and textured. Each MENTOR® MemoryGel™ Breast Implant is provided sterile. MemoryGel Breast Implants are available in sizes ranging from 100 cc-800 cc and 4 styles with various projection and height options.
15996105|NCT02919592|Procedure|Other Aesthetic Surgery|Other aesthetic surgery procedures (for example, liposuction, rhinoplasty, brow lift, autoplasty, rhytidectomy, mentoplasty/genioplasty, otoplasty, or blepharoplasty; may not include silicone implants)
15996106|NCT02919579|Drug|Placebo (Intranasal)|Participants will receive intranasal placebo in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.
15996107|NCT02919579|Drug|Esketamine|Participants will receive intranasal esketamine in Part A (as per the treatment sequence in period 1,2 and 3) and Part B.
15996108|NCT02919579|Other|Alcohol|Participants will receive oral alcohol in Part A (as per the treatment sequence in period 1,2 and 3).
15996109|NCT02919579|Drug|Placebo (Oral)|Participants will receive oral placebo in Part A (as per the treatment sequence in period 1,2 and 3).
15996110|NCT02919553|Procedure|modified wet-suction technique|Normal saline will be present in this needle, and once in the lesion of interest the suction will be re-established and the needle will be moved in a to-and-fro motion to collect the sample of interest. Then the sample will be collected.
15996111|NCT02919553|Procedure|"Capillary slow pull technique"|The needle will be introduced into the lesion of interest and using the to-and-fro motion, collect the sample. The needle will then be withdrawn and the sample will then be collected.
15996112|NCT02919540|Other|Kangaroo care approach|skin to skin contact between stable preterm infants and their naked mother's chest
15996113|NCT02919527|Other|Self-Myofascial-Release|Self-Myofascial-Release performed at the anterior thigh
15996114|NCT02919527|Other|Stretching|Static Stretching performed at the anterior thigh
15996115|NCT02919514|Other|Physical training on hard surface.|Physical training on hard surface.
15996116|NCT02919514|Other|Physical training on sand surface.|Physical training on sand surface.
15996117|NCT02919514|Other|Physical training on soft surface.|Physical training on soft surface.
15996118|NCT02919501|Drug|Vortioxetine (IV)|17 mg, solution for infusion, administered, over 2 hours as single dose
15996119|NCT02919501|Other|Placebo (IV)|Saline: isotonic sodium chloride, administered, over 2 hours as single dose
15996120|NCT02919501|Drug|Vortioxetine (tablet)|10 mg, tablets, oral administration once daily for 15 days (open labelled)
15996121|NCT02919488|Other|Exercise Condition|A bout of exercise in the evening followed by high-sugar meal consumption the following morning
15996122|NCT02919488|Other|Control Condition|Rest in the evening followed by high-sugar meal consumption the following morning
15996123|NCT02919475|Drug|JTE-051|Active drug tablets containing JTE-051
15996124|NCT02919475|Drug|Placebo|Placebo tablets identical in appearance to the active drug tablets
15996125|NCT02919462|Drug|Oral vinorelbine|Oral vinorelbine 60-80 mg/m2 on days 1 and 8 (first cycle 60 mg/m2) every 3 weeks, for 4 cycles
15996126|NCT02919462|Drug|Cisplatin|Cisplatin 80 mg/m2 on day 1 every 3 weeks, for 4 cycles
15996127|NCT02919462|Drug|Maintenance with Metronomic Oral Vinorelbine|Maintenance with Metronomic Oral Vinorelbine 50 mg three times a week on Monday, Wednesday and Friday continuously until disease progression, patient refusal or excessive toxicity (1 cycle: 3 weeks).
15996128|NCT02919462|Drug|Pemetrexed|Pemetrexed, 500 mg/m2, day 1 every 3 weeks, for 4 cycles
15996129|NCT02919462|Drug|Cisplatin|Cisplatin 75 mg/m2, day 1 every 3 weeks, for 4 cycles
15996130|NCT02919462|Drug|Maintenance with Pemetrexed|Maintenance with Pemetrexed 500 mg/m2 day1 q 21 until disease progression (1 cycle: 3 weeks)
15996131|NCT02919449|Biological|MV-NIS|This is an open label single ascending dose phase I study designed to determine the safety profile and MTD after IT administration of a single dose of MV-NIS in combination with Atezolizumab in patients with metastatic NSCLC
15996132|NCT02919449|Biological|Atezolizumab|Atezolizumab will be administered every 3 weeks
15996133|NCT02919436|Drug|Tamsulosin|Active drug
15996134|NCT02919436|Drug|Placebo|Lactose-filled capsules identical to active drug
15996135|NCT02919423|Device|transcranial magnetic stimulation|
15996136|NCT02919410|Device|iodophor-impregnated adhesive drapes|
15996137|NCT02919410|Other|No adhesive drapes|
15996138|NCT02919397|Device|Wearable technology|Buddi wearable technology will record activity levels, participants will access activity data through smartphone application
15996139|NCT02919397|Behavioral|Diabetes Prevention Programme educational material|Educational material accessed through smartphone application
15996140|NCT02919397|Behavioral|Motivational messaging|Messages sent via smartphone application
15996141|NCT02919384|Other|2% oxygen concentration in the incubator|"At the time that embryos are changed from cleavage stage media to blastocyst stage media on day 3 of development, half of a given patient's embryos will randomly be placed in an incubator set at 2% oxygen concentration. The splitting of the embryos will be done under low magnification such that the embryologist will have no ability to bias allocation of embryos to 2% or 5% oxygen based on embryo morphology on day 3. The embryos will remain in this incubator until their developmental assessments on day 5 and 6."
15996142|NCT02919371|Drug|Sunitinib|Oral therapy ( Anti-vascular endothelial growth factor Tyrosin Kinase Inhibitor): given as 50 mg daily from day 1 to day 28- cycle repeated every 42 days
15996143|NCT02919371|Drug|Bevacizumab|Monoclonal antibody against vascular endothelial growth factor: given intravenously on day 29 of each sunitinib cycle
15996144|NCT02919358|Other|Music|
15996145|NCT02919358|Other|No music.|This is the control group.
15996146|NCT02919345|Drug|Dapagliflozin 10 mg|Dapagliflozin 10 mg in addition to Metformin 1500 mg/day
15996147|NCT02919345|Drug|Glibenclamide 5 mg|Glibenclamide 5 mg in addition to Metformin 1500 mg/day
15996148|NCT02919332|Procedure|Computed Tomography|Undergo 18F-FDG PET/CT
15996149|NCT02919332|Radiation|Fludeoxyglucose F-18|Given IV
15996150|NCT02919332|Procedure|Positron Emission Tomography|Undergo 18F-FDG PET/CT
15996151|NCT02919319|Drug|ACT-541468 (Formulation A)|Hard gelatin capsules for oral administration formulated at strengths of 5 mg, 25 mg and 100 mg
15996152|NCT02919319|Drug|ACT-541468 (Formulation B)|Soft gelatin capsules for oral administration formulated at the strength of 25 mg
15996153|NCT02919319|Drug|Placebo (Formulation A)|Hard capsules matching ACT-541468 Formulation A
15996154|NCT02919319|Drug|Placebo (Formulation B)|Soft capsules matching ACT-541468 Formulation B
15996155|NCT02919319|Drug|14C-labeled ACT-541468|Tracer at a nominal dose of 250 nCi (corresponding to 2.02 µg ACT-541468) administered either orally or intravenously
15996156|NCT02919319|Drug|Placebo tracer|Sterile NaCl 0.9% was used as placebo matching the tracer for oral and i.v. administration.
15996157|NCT02919306|Biological|Ad26.Mos.HIV|Recombinant replication-deficient Ad26 vectored vaccine and consists of 3 Ad26 vectors, one containing a mosaic insert of envelope (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5*10^10 viral particle per 0.5 milliliter (mL) injection administered intramuscularly.
15996158|NCT02919306|Biological|MVA-Mosaic|Recombinant live attenuated MVA virus-vectored vaccine that has been genetically engineered to express 2 mosaic Gag, Pol, and Env sequences (Mosaic 1 and Mosaic 2). Total dose is 10^8 plaque-forming unit per 0.5 mL injection administered intramuscularly.
15996159|NCT02919306|Drug|Placebo|Participants will receive placebo intramuscularly Weeks 0, 12, 24 and 48.
15996160|NCT02919293|Biological|Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine (adjuvant-free)|30μg /dose, Intramuscular
15996161|NCT02919293|Biological|Meningococcal Groups A and C and Haemophilus b Conjugate Vaccine(adjuvant)|0.5ml /dose, Intramuscular
15996162|NCT02919280|Other|Observational Study|The Dallas 2K is a 10-year natural history, longitudinal, prospective study of a cohort of 2,000 participants. There is no medication or non-medication treatment or intervention provided by this study.
15996163|NCT02919267|Device|Double lumen tube|Either gaseous volume quantification or intrapulmonary pressure measurements will be done in patients randomized in the L-DLT group.
15996164|NCT02919267|Device|Bronchial blocker|Either gaseous volume quantification or intrapulmonary pressure measurements will be done in patients randomized in the BB group.
15996165|NCT02919254|Dietary Supplement|Beet It Sport Shot|Commercially available concentrated beetroot juice supplement intended for athletes.
15996166|NCT02919254|Other|Placebo|Fruit juice cordial containing negligible nitrate
15996167|NCT02919241|Behavioral|Diagnostic interview|A profound interview to declare causes for negative thoughts, assumptions and beliefs towards dental care. Participants come from public and Private dental care.
15996168|NCT02919241|Behavioral|Combined interview and treatment.|Intervention for this group include both the diagnostic interview to declare causes for negative thoughts, assumptions and beliefs towards dental care and one session treatment. Participants come from the Institute of Dentistry.
15996169|NCT02919228|Other|Visible light exposure|Subjects will be exposed to visible colored light for 15 minutes. The visible light will be generated by red-green-blue light emitting diodes light cans.
15996170|NCT02919215|Behavioral|Teacher Help Intervention|The intervention will be provided to collaborating psychologists and their teachers to access. Teachers will work through the intervention, and psychologists will act as the online support for teachers. Teachers will work with one student in their classroom with ADHD, ASD, or LD throughout the intervention phase. Each session in the program will provide factual information to teachers, strategies for implementation of best practices to address the specific mental health disorder in the classroom setting (i.e., ADHD, ASD, or LD), and access to additional help and advice.
15996171|NCT02919202|Procedure|Colgate Fluoride Varnish Suspension. 2.26% Sodium Fluoride.|Topical application to exposed dentine on one occasion.
15996172|NCT02919202|Procedure|Self-etching Dentine Bonding Agent|Topical application to exposed dentine on one occasion followed by light-curing procedure.
15996173|NCT02919189|Other|Visible light exposure|Subjects will be exposed to visible colored light for 15 minutes. The visible light will be generated by fluorescent light lamps.
15996174|NCT02919176|Drug|Mirabegron|Mirabegron 50 mg/day
15996175|NCT02919176|Drug|Pioglitazone|Pioglitazone 30 mg/day
15996176|NCT02919176|Drug|Mirabegron and Pioglitazone|Mirabegron 50 mg/day and Pioglitazone 30 mg/day
15996177|NCT02919163|Other|Visible light exposure|Subjects will be exposed to visible colored light for 15 minutes. The visible light will be generated by incandescent white light bulbs and color filters.
15996178|NCT02919137|Other|Visible light exposure|Subjects will be exposed to visible colored light for 45 minutes. The visible light will be generated by red-green-blue light emitting diodes light cans.
15996179|NCT02919124|Device|Echoclip|An ultrasound transducer positioning device, the Echoclip device (Aalborg Hospital, Aalborg,Denmark), which can stabilize the involved part of the myocardium on the beating heart, keep the gel at place, and position the ultrasound transducer correctly for imaging will be used for visualising the coronary bypass anastomoses during surgery
15996180|NCT02919111|Drug|Ga-68 labeled PSMA-11 PET|Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.
15996181|NCT02919098|Behavioral|Bystander, a game-based bystander intervention program|A game-based, high school age-appropriate program delivered by trained facilitators for sexual violence and harassment intervention
15996182|NCT02919098|Behavioral|Infection City, a game-based program about meningitis|A game-based, high school age-appropriate program delivered by trained facilitators to teach students about meningitis.
15996183|NCT02919085|Procedure|Early ambulation|Procedure to accelerate the ability of a patient to walk or move about by reducing the time to ambulation. It is characterized by a shorter period of hospitalization or recumbency than is normally practiced.
15996184|NCT02919072|Drug|Chloroprocaine|The 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered.
15996185|NCT02919072|Drug|Ropivacaine|The 20 mL epidural anaesthetic solution will be administered as follows: 5 mL of the study anaesthetic solution will be given epidurally and the block will be assessed after 2 minutes from the first injection using cold, pinprick and touch. Then intrathecal placement will be excluded and a further 15 mL of the study anaesthetic solution will be administered epidurally. Two minutes after the start of the second injection, the sensory block will be re-assessed using cold, pinprick and touch. In case of pain or discomfort a 6 mL epidural top-up of the same anaesthetic will be administered.
15996186|NCT02919059|Drug|Dapagliflozin 10 mg|"Dagliflozin will be administred once daily before the first meal of the day for the duration of the study or until early discontinuation. Subjects will take the first dose of study drug at the study centre on Day 1.
~On the day of study visits when fasting blood samples are collected, subjects will be instructed to refrain from taking the study drug before the clinic visit. The subject will be instructed to take the dose of study drug before the subject´s next meal.
~The study drug must be swallowed whole with liquid and not chewed, divided, dissolved or crushed. If the subject doesn´t take the study drug within 12 hours after the first meal of the day, the dose of the study drug should be skipped for that day and keep on taking the study drug on the following day before the first meal."
15996187|NCT02919059|Drug|Glimepiride 4 mg|"Glimepiride will be administred once daily before the first meal of the day for the duration of the study or until early discontinuation. Subjects will take the first dose of study drug at the study centre on Day 1.
~On the day of study visits when fasting blood samples are collected, subjects will be instructed to refrain from taking the study drug before the clinic visit. The subject will be instructed to take the dose of study drug before the subject´s next meal.
~The study drug must be swallowed whole with liquid and not chewed, divided, dissolved or crushed. If the subject doesn´t take the study drug within 12 hours after the first meal of the day, the dose of the study drug should be skipped for that day and keep on taking the study drug on the following day before the first meal."
15996188|NCT02919046|Biological|GD2-targeted CAR-T cells|This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-GD2-modified T cells can recognize and kill tumor cells in the body，follow-up 35 months.
15996189|NCT02919033|Other|Usual care|The hypertension care of this arm complies with the national guideline and includes designated follow-ups by PCPs once every 1-3 months for stage-1 (≥ 140/90 mm Hg) hypertension patients, once every 1 month for stage-2 (≥ 160/100 mm Hg) and once every 2 weeks for stage-3 (≥ 180/110 mm Hg) patients.
15996221|NCT02918851|Biological|Transfusion of 7-day stored red blood cells|Subjects will donate blood at Week 0 and Week 5 of their participation and receive, at Week 6, back a transfusion of their Week 5 (7-day old) red blood cells.
15996222|NCT02918851|Biological|Transfusion of 28-day stored red blood cells|Subjects will donate blood at Week 2 and Week 5 of their participation and receive, at Week 6, back a transfusion of their Week 2 (28-day old) red blood cells.
15996190|NCT02919033|Device|Self-management|"Usual care
~Patients receive a BP telemedicine system developed by CareLinker Inc. (Shanghai, China) to facilitate BP self-management in addition to all the usual care components. The system consists of: 1) a BP tele-monitor with embedded GSM module that can upload BP readings; 2) a mobile App that allows patients to manually input healthcare data, display history BP measurements and lab test results, receive personalized lifestyle coaching contents and medication reminders, and communicate with PCPs through text-messaging.
~All patients receive proficiency training in using the BP tele-monitor, and mobile App."
15996191|NCT02919033|Other|PCTM intervention|"Usual care
~Self-management
~PCPs and cardiologists use the secure CareLinker website to review patient data including BP measurements, lab test results and medications in use and comorbidities. The auto analytics tools of the website reveal BP average, BP trend, and risk score of each patient. Text alerts of abnormal BP variability will be pushed to PCPs' App when they occur and proactive interventions including phone consultation and medication dosage adjustment will be offered. A case review session will be set once every 1-2 months for PCPs and cardiologists to exam patients' disease progresses. The proprietary web-based analytic module also produces automated individualized medication recommendations to PCPs.
~PCPs and cardiologists receive training of the CareLinker website."
15996192|NCT02919020|Other|Proprioceptive neuromuscular facilitation (PNF)|Proprioceptive neuromuscular facilitation, using the technique of rhythmic initiation and Combination of Isotonic on lower members
15996193|NCT02919020|Other|Resistance exercise|resistance exercise to strengthen lower limbs
15996194|NCT02919007|Device|Silk'n HST treatment|Intervention includes treatment with the Silk'n HST on the periorbital areas as instructed in the user's manual
15996195|NCT02918994|Behavioral|LearningRx cognitive training|A clinician will deliver three 90-minute cognitive training sessions per week for 14 weeks. There are 16 different categories of leveled training procedures sequenced in intensity and difficulty for a total of 530 training tasks.
15996196|NCT02918981|Behavioral|Resistance Exercise|Participants will perform unilateral leg extension exercise immediately prior to ingestion of the experimental beverage
15996197|NCT02918981|Dietary Supplement|14 g Whey protein|
15996198|NCT02918981|Dietary Supplement|6.6 g Whey protein + 1.25 g leucine|
15996199|NCT02918981|Dietary Supplement|4 g Whey protein + 1.25 g leucine + 2.6 g Whey peptides|
15996200|NCT02918981|Dietary Supplement|6.6 g Whey protein + 1.25 g leucine + 0.8 g Citrulline|
15996201|NCT02918981|Other|Water control|
15996202|NCT02918968|Drug|Enzalutamide|Oral Capsule
15996203|NCT02918968|Drug|Flutamide|Oral tablet
15996204|NCT02918968|Other|Androgen deprivation therapy|All subjects must undergo continuous Androgen deprivation therapy with GnRH agonist/antagonist or bilateral orchiectomy during the study period.
15996205|NCT02918955|Procedure|up-front neck dissection|
15996206|NCT02918955|Radiation|radiotherapy|70 Gy in 35 fractions to the macroscopic disease 50 Gy in 25 fractions (if sequential boost) or 56 Gy in 35 fractions (if simultaneous integrated boost) to the elective volumes 66 Gy in 35 fractions to the post-operative region with lymphatic extracapsular extension (Arm B only)
15996207|NCT02918955|Drug|Chemotherapy (Cisplatin)|"100 mg/m2 every three weeks during radiotherapy
~In Arm B, chemotherapy can be omitted in case of a cT1-2 primary and a surgical downstaged pN0-1 neck without lymphatic extracapsular extension."
15996208|NCT02918955|Procedure|Early Salvage Neck Dissection in case of less than cCR (Arm A only)|"Early salvage neck dissection in case of residual lymph node disease will be performed based on the response evaluation by MRI and PET/CT performed 3 and 4 months after the end of (chemo)radiotherapy, respectively (and additional diagnostic modalities if clinically indicated by the physician) and not more than 3 weeks after this post-radiotherapy evaluation.
~In Arm A, a successful early salvage neck dissection without the operation of the primary tumor in case of less than clinical complete response (cCR) will be considered a component of the multimodality treatment and not as a failure."
15996209|NCT02918929|Drug|EDP 305|
15996210|NCT02918929|Drug|Placebo|placebo to match EDP 305
15996211|NCT02918916|Other|Phototherapy|The dosage applied will be 30 Joules per site (180 Joules per muscle). Parameters are described in the attached document.
15996212|NCT02918916|Other|Placebo|The same procedures as in the active phototherapy group will be applied to the placebo phototherapy group; however the emitter will be disabled.
15996213|NCT02918903|Procedure|Minimal caries removal|the experimental group will be treated by minimal caries removal where only caries at lateral walls of cavity will be removed then stainless steel crown will be placed as final restoration.
15996214|NCT02918903|Procedure|Complete caries removal|the control group will be treated by complete caries removal where all caries along lateral and pulpal walls of cavity will be removed, a base of resin modified glass ionomer will be placed then stainless steel crown will be placed as final restoration.
15996215|NCT02918890|Other|Constraint-induced Movement Therapy|
15996216|NCT02918890|Other|Hand-arm Bimanual Intensive Therapy|
15996217|NCT02918877|Drug|Sevoflurane|Volatile Anesthetic
15996218|NCT02918877|Drug|Propofol|Intravenous Anesthetic
15996219|NCT02918864|Drug|Oxytocin and social cognitive skills group|This is an integrated pharmacological-behavioral intervention targeting social cognitive skills for school-aged children with ASD. Four doses of intranasal oxytocin (24 IUs/dose) will be delivered each week before weekly homework and group therapy sessions. Social cognitive skills training utilize cognitive behavioral strategies such as problem identification, affective education, performance feedback, and weekly homework activities to target impairments in nonverbal synchrony, emotional expression, and interpretation of intent. The NETT curriculum is manualized and anchored in CBI strategies, such as problem identification, affective education, performance feedback, and weekly homework activities. Parent education sessions run concurrently with child groups to help facilitate generalization.
15996220|NCT02918864|Behavioral|Facilitated Play Therapy|The facilitated play therapy group is a manualized treatment designed to tailor play to the interests and abilities of group members. Therapists use general therapeutics strategies such as reflective functioning statements to foster communication with therapists as well as between peers. Standard educational practices for children with ASD such as visual supports, schedules, and short-directed statements are also used. The concurrent parent group is supportive in nature.
15996283|NCT02918552|Drug|Control|Subjects randomized to placebo to receive three times daily during treatment period and then post treatment testing period.
15996223|NCT02918851|Biological|Transfusion of 42-day stored red blood cells|Subjects will donate blood at Week 0 and Week 5 of their participation and receive, at Week 6, back a transfusion of their Week0 (42-day old) red blood cells.
15996224|NCT02918838|Behavioral|Own Adherence Group|Participant chooses their adherence level to be reached at next clinic visit (at least 80%, but can be higher). If they reach that percentage measured using the MEMS cap, they can participate in a lottery for an airtime reward of none, a small amount, and a larger amount. Participants also receive a weekly motivational message reminding them of their incentive to adhere. If they respond to the message they will receive airtime top-up.
15996225|NCT02918838|Behavioral|Fixed Adherence Group|Participant is told to meet a pre-determined target of 90%. If they reach that percentage measured using the MEMS cap, they can participate in a lottery for an airtime reward of none, a small amount, and a larger amount. Participants also receive a weekly motivational message reminding them of their incentive to adhere. If they respond to the message they will receive airtime top-up.
15996226|NCT02918838|Behavioral|Control Group|
15996227|NCT02918825|Drug|Olanzapine|Olanzapine
15996228|NCT02918825|Drug|Paliperidone|Paliperidone
15996229|NCT02918812|Drug|Intracervical lidocaine|Intracervical lidocaine injected at four different points
15996230|NCT02918812|Drug|Intramuscular Diclofenac|Intramuscular Diclofenac 30 mins before HSG
15996231|NCT02918799|Behavioral|Mpowerment|MP is a multi-level intervention that reaches out to all YMSM in a community by mobilizing men to encourage their friends to reduce risk behavior and join the program (informal outreach), along with holding social activities that promote safe sex (formal outreach). MP provides YMSM with skills, support and confidence to find solutions within themselves for sexual health, and seeks to affirm the validity and rights of same-sex behavior and identities.
15996232|NCT02918786|Device|Nasal high-flow|After extubation, the patients will receive oxygen delivered through the nasal high-flow system (Optiflow™). The FiO2 will be adjusted in order to obtain a SpO2 between 92% and 98% in hypoxemic patients and between 88% and 95% in hypercapnic patients. Gas flow will be set until maximal level of 60 LPM.
15996233|NCT02918786|Device|CPAP|After extubation, patients will receive CPAP at 5 cmH2O delivered by the variable generator WhisperFlow System. The FiO2 will be adjusted in order to obtain a SpO2 between 92% and 98% in hypoxemic patients and between 88% and 95% in hypercapnic patients.
15996234|NCT02918773|Device|Smartphone otoscope|A smartphone otoscope is a pocket size smartphone attachment that uses the technology and light source of a smartphone to capture reproducible images of the ear canal and tympanic membrane. The smartphone otoscope has the capability to capture still images and video, which can be referred to post-examination as well as be incorporated into an electronic medical record. Clinicians will use the smartphone otoscope for the duration of the 6-month study period.
15996235|NCT02918773|Device|Conventional otoscope|A conventional otoscope has a light and lenses to provide a view of the ear canal and tympanic membrane or eardrum. Clinicians will use the conventional otoscope for the duration of the 6-month study period.
15996236|NCT02918760|Drug|Gabapentin|This group will include (32) women according to inclusion and exclusion criteria and will receive a card of Gabapentin which will be taken orally by the patient at home three times daily and maximum dose 2700mg per day by 300 mg increments each week until sufficient pain relief, or the occurrence of side effects such as dizziness, somnolence, edema and ataxia.
15996237|NCT02918760|Other|Placebo|Group B (controls):This group will include (32) women according to inclusion and exclusion criteria and will receive a card of placebo.
15996238|NCT02918747|Drug|pegaspargase|"P-Gemoxd Arm: 2000U/m2 im on day 1 of each 21 day cycle. Number of Cycles: four.
~P-CHOP Arm: 2000U/m2 im on day 2 of each 21 day cycle. Number of Cycles: four."
15996239|NCT02918747|Drug|Gemcitabine|800mg/m2, ivd on day 1 and 5 of each 21 day cycle. Number of Cycles: four.
15996240|NCT02918747|Drug|Oxaliplatin|85 mg/m2 ivd on day 1 of each 21 day cycle. Number of Cycles: four
15996241|NCT02918747|Drug|Dexamethasone|15 mg, Ivd on day 1 to day 5 of each 21 day cycle. Number of Cycles: four.
15996242|NCT02918747|Drug|Cyclophosphamide|750 mg/m2，ivdrip day 1 of each 21 day cycle. Number of Cycles: four.
15996243|NCT02918747|Drug|Doxorubicin|50mg/m 2，ivdrip day 1 of each 21 day cycle. Number of Cycles: four.
15996244|NCT02918747|Drug|Vincristine|1.4 mg/m 2(≤2mg），ivdrip day 1 of each 21 day cycle. Number of Cycles: four.
15996245|NCT02918747|Drug|Prednisone|60 mg/m 2 /day orally on days1- 5 of each 21 day cycle. Number of Cycles: four.
15996246|NCT02918747|Radiation|IMRT|After chemotherapy, if the patients get CR, PR or SD, IMRT is delivered using 6-8 MeV linear accelerator using intensity-modulated radiation treatment planning. The radiation dose is 50 -56grays (Gy) in 25-28 fractions.
15996247|NCT02918734|Device|Endobutton CL BTB|ACL reconstruction with Endobutton CL BTB
15996248|NCT02918734|Device|Metal interference screw|ACL reconstruction with metal interference screw
15996249|NCT02918721|Device|Restylane Lidocaine|Intradermal injection
15996250|NCT02918721|Device|Restylane|Intradermal injection
15996251|NCT02918708|Biological|Synflorix|10-valent pneumococcal conjugate vaccine
15996252|NCT02918708|Biological|Prevenar13|13-valent pneumococcal conjugate vaccine
15996253|NCT02918682|Other|Exercise - FIRST PHASE|the participants do not need to perform the first phase or can advance to the second phase if they have obtained the following results in the balance and functional tests: 1. Gait speed of 0.8 m/s and walking 30 meters without stopping; 2. Ability to perform the stand up and sit down test from the chair five times properly within less than 15 seconds; 3. Maintaining the FFEO stance for 30 seconds and the Tandem EO stance for more than 5 seconds; 4. Having sitting stability limits with eyes open; 5. In upright position, able to bend the trunk forward, standing parallel to a wall, between 16.5 - 32 cm but stable. For the muscle strength: being able to perform hip flexion with 50% of 1 repetition maximum (RM) for 8 repetitions; hip extension with 50% of 1RM for 8 repetitions; hip abduction without load but at least for 8 repetitions; knee extension with 50% of 1RM for 8 repetitions; knee flexion with 50 % of 1RM for 8 repetitions;
15996284|NCT02918539|Drug|florbetapir F 18 PET scan|For those patients who do not have an existing amyloid scan, each will receive an IV injection, 370 MBq (10 mCi), single dose of florbetapir F 18 followed by a Positron Emission Tomography (PET) Scan to determine amyloid status
15996285|NCT02918526|Device|airway management|airway management with Laryngeal Mask or Oro Tracheal Intubation
15997141|NCT02912182|Drug|Prednisolone|Oral tablets
15996254|NCT02918682|Other|Exercise - SECOND PHASE|the participants do not need to perform the second phase or can advance to the third phase if they have obtained the following results in the balance and functional tests: 1. Gait speed of 0.8-1 m/s and ability to walk 60 meters; 2. Ability to perform the stand up and sit down test from the chair five times properly within less than 15 seconds; 3. Maintaining the FFEO and FFEC stance for more than 5 seconds and the Tandem EO stance for 10-20 seconds; 4. Having sitting stability limits with eyes closed; 5. Being able to bend the trunk forward, standing parallel to a wall, between 20-32 cm ad being stable. For muscle strength: being able to perform hip flexion with 60% of 1 RM for 8 repetitions; hip extension with 60% of 1RM for 8 repetitions; hip abduction without load but between 8-12 repetitions; knee extension with 60% of 1RM for 8 repetitions; knee flexion with 60% of 1RM for 8 repetitions;
15996255|NCT02918682|Other|Exercise - FOURTH PHASE|at the end of the exercise protocol, the participants who have reached the fourth phase must be able to achieve: 1. Gait speed of 0.8-1 m/s and able to walk 90 meters; 2. Stand up and sit down five times from the chair properly within less than 15 seconds; 3. TUG performance less than 14 seconds; 4. Maintenance of 30 seconds in FFEO and FFEC stance, maintenance of 30 seconds in Tandem EO and Tandem EC stance, maintenance of the single-leg stance for more than 21 seconds; 5. Normal sitting stability limits with eyes closed; 6. Bending the trunk forward, standing parallel to a wall, more than 32 cm and being stable. For muscle strength: able to perform hip flexion with 70% of 1 RM for 6-10 repetitions; hip extension with 70% of 1RM for 6-10 repetitions; hip abduction with 40-60% of 1RM for 8-12 repetitions; knee extension with 70% of 1RM for 6-10 repetitions; knee flexion with 70% of 1RM for 6-10 repetitions.
15996256|NCT02918682|Other|Exercise - THIRD PHASE|participants do not need to perform the third phase or can advance to the fourth phase if they have obtained: 1 Gait speed of 0.8-1 m/s and walk 90 meters; 2 perform the stand up and sit down five times from the chair properly within less than 15 seconds; 3 Performing the TUG test within less than 14 seconds; 4 Maintaining the FFEO and FFEC stance for 30 seconds, maintaining the Tandem EO and Tandem EC stance for 30 seconds and maintaining the single-leg stance for more than 20 seconds; 5 Having sitting stability limits with eyes closed; 6 In the upright position, to bend the trunk forward, standing parallel to a wall, more than 32 cm and being stable. For the muscle strength test, perform hip flexion with 60 % of 1 RM for 8-12 repetitions; hip extension with 60 % of 1RM for 8-12 repetitions; hip abduction without load or 5% of 1RM for hip abductor and between 8-12 repetitions; knee extension with 60 % of 1RM for 8-12 repetitions; knee flexion with 60 % of 1RM for 8-12 repetitions;
15996257|NCT02918669|Radiation|CT Scan|"Patients in the coflex IDE Study who presented at 24 months with a spinous process fracture that will undergo a CT Scan to evaluate the evidence or healing of fracture post-60 months.
~There are no other interventions. It is just a onetime CT post 60 month time point."
15996258|NCT02918656|Other|Infographic presentation of health information|"The students in this group will read Cochrane systematic review summary in infographics format.
~Infographics format is a form of visual presentation of results of systematic review, supported by pictures and graphs."
15996259|NCT02918656|Other|PLS presentation of health information|The students randomized in PLS group will read text format with simple explanation of the survey topic main findings which is intended for lay audience.
15996260|NCT02918656|Other|Scientific abstract presentation of health information|The students in scientific abstract group will read the the text written for the academic population and practitioners.
15996261|NCT02918643|Other|Use of an application to for mobile devices like decision-making support for prescription drugs to elderly patients|
15996262|NCT02918630|Drug|Nicotine Patch|Participants will receive nicotine patch (21 mg) starting study Week 1. Participants will be instructed to apply a new patch each morning.
15996263|NCT02918630|Drug|E-cigarette|The e-cigarette will consist of 1) a 3.3 V, 1000 mAh battery; and 2) a 1.5 Ohm, dual-coil cartomizer (SmokTech; Shenzhen, China). Study staff will load the cartomizer with 1 ml tobacco flavored 70% propylene glycol/30% vegetable glycerin liquid containing nicotine concentrations 36 mg/ml (AVAIL; Richmond, Virginia, USA).
15996264|NCT02918617|Drug|Control toothpaste containing Novamin® technology|
15996265|NCT02918617|Drug|Control toothpaste containing 1500 ppm fluoride as MFP|
15996266|NCT02918617|Drug|Test toothpaste with nano-HAP (high concentration)|
15996267|NCT02918617|Drug|Test toothpaste with nano-HAP (low concentration)|
15996268|NCT02918617|Drug|Test toothpaste with nano-HAP and (Potassium Nitrate) KNO3|
15996269|NCT02918617|Drug|Control toothpaste without nano-HAP|
15996270|NCT02918617|Drug|Test toothpaste with nano-HAP (medium concentration)|
15996271|NCT02918617|Drug|Test cream with nano-HAP (higher concentration)|
15996272|NCT02918617|Drug|Control cream without nano-HAP|
15996273|NCT02918604|Device|infrared technology: Veinsite|peripheral vein access performed with Veinsite support by expert paediatric anaesthesiologists and intensivists
15996274|NCT02918591|Drug|Empagliflozine|All 6type 2 diabetic participant will receive treatment with Empagliflozine during 2 month
15996275|NCT02918578|Other|"Phone group"|"Participants in the phone group receive 12 individually tailored coaching sessions (15 - 20 min). The coaching calls are scheduled biweekly. Participants receive their tailored advice via interactive counseling."
15996276|NCT02918578|Other|"Phone and SMS group"|"The phone and SMS group receive the same coaching as the phone group. They additionally receive two tailored SMS per week over the course of six months."
15996277|NCT02918578|Other|"single writing group"|"The control intervention consists of a minimal credible physical activity PA promotion program. Participants in the control group receive a singular written advice and an activity plan but no counseling by phone."
15996278|NCT02918565|Behavioral|Drinking Cognition Feedback (DCF)|12 weeks of interactive text messaging focused on providing feedback related only to pre-weekend drinking cognitions (plans, desire to get drunk).
15996279|NCT02918565|Behavioral|Alcohol Risk Feedback (ARF)|12 weeks of interactive text messaging focused on providing feedback related only to post-weekend alcohol consumption (max drinks consumed on any occasion over the weekend).
15996280|NCT02918565|Behavioral|Adaptive Goal Support (AGS)|12 weeks of interactive text messaging focused on providing adaptive goal support (based on running average of max drinks consumed).
15996281|NCT02918565|Behavioral|COMBO|12 weeks of interactive text messaging incorporating features of DCF, ARF and AGS.
15996282|NCT02918552|Drug|sodium nitrite|Subjects to receive active study drug three times daily during treatment period and then post treatment testing period.
15996286|NCT02918513|Behavioral|Wellness Element 1 - Exercise|1. Daily wellness element focusing on Exercise; adherence documented online daily
15996287|NCT02918513|Behavioral|Wellness Element 2 - Mindfulness|2. Daily wellness element focusing on Mindfulness Meditation; adherence documented online daily
15996288|NCT02918513|Behavioral|Wellness Element 3 - Sleep Hygiene|3. Daily wellness element focusing on sleep hygiene; adherence documented online daily
15996289|NCT02918513|Behavioral|Wellness Element 4 - Social Connectedness|4. Daily wellness element focusing on Social Connectedness; adherence documented online daily
15996290|NCT02918513|Behavioral|Wellness Element 5 - Nutrition|5. Daily wellness element focusing on Nutrition; adherence documented online daily
15996291|NCT02918513|Behavioral|Wellness Element 6 - Wellness Exercises|6. Daily wellness workbook exercises focusing on improving mental wellness; adherence documented online daily
15996292|NCT02918513|Behavioral|Wellness Element 7 - Motivational Messages|7. Daily motivational emails offering information on one of the 5 wellness elements each day (Exercise, Mindfulness Meditation, Sleep, Social Connectedness, and Nutrition)
15996293|NCT02918500|Drug|Nicoderm Patch|Nicotine replacement therapy patch
15996294|NCT02918487|Drug|Polyherbal|Each capsule contains four herbs: Inula racemosa, Ocimum sanctum, Terminalia Belerica and Piperum longum
15996295|NCT02918487|Drug|Placebo|Inactive compound that is similar looking as the intervention
15996296|NCT02918474|Other|Decision Aid|Use decision making tool
15996297|NCT02918474|Other|Questionnaire Administration|Ancillary studies
15996298|NCT02918461|Behavioral|Emerging from the Haze class|A 6-week class designed to combat chemotherapy-induced cognitive dysfunction. Patients will report symptoms at 6 months and 1 year after the end of their Haze class.
15996299|NCT02918448|Other|Training group|The investigation was carried out over a period of 18 weeks, with 12 weeks dedicated to the RT program and 6 weeks allocated for measurements. Anthropometric, one repetition maximum tests (1RM), body composition, blood pressure (BP), dietary intake and blood sample measurements were performed in weeks 1-3, and 16-18. A supervised progressive RT program was performed between weeks 4-15 by the training group.
15996300|NCT02918435|Behavioral|WE CARE|The WE CARE (Well-child care visit, Evaluation, Community Resources, Advocacy, Referral, Education) survey consists of 12 questions used to identify six unmet material needs (education, employment, food security, housing, childcare, household utilities). It will be administered at health supervision visits during the WE CARE phase at each study site. The Family Resource Book will contain resource information sheets for each of these needs listing available community resources. A physician champion will conduct regular booster sessions every 4 months and train new providers should there be staff turnover.
15996301|NCT02918422|Other|Nutritional and Dietary Manipulation|Participants will undertake a controlled feeding intervention. All food will be prepared and delivered to participants by research staff. Participants will be asked to exclusively eat what is provided to them in efforts to control any dietary effects.
15996302|NCT02918409|Drug|Colistin|
15996303|NCT02918409|Drug|Tobramycin|
15996304|NCT02918396|Device|Scar-Based Radio-frequency Ablation|Left atrial (LA) myocardium will be manually segmented prior to the procedure and 3D-volumes of the atrial anatomy with superimposed dense LGE maps will be generated. Prior to the PVI, a dense voltage map of the left atrium will be performed (>1000 points) iin sinus rhythm. After PVI, low voltage areas (defined as <0.3 mV) which are superimposed on dense LGE on the MRI will be targeted by radio frequency ablation with a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation.
15996305|NCT02918396|Device|Rotor Anchors Radio-frequency Ablation|Left atrial (LA) myocardium will be manually segmented prior to the procedure and the LA shell, along with the LGE-MRI will be sent to the biomedical engineering team who will generate a 3D-model of the LA along with rotor anchor sites predicted by modeling. After the PVI, the 3D models will be displayed and the rotor anchor sites will be targeted by radiofrequency ablation with a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation.
15996306|NCT02918396|Device|Conventional PVI by Radio-frequency Ablation|Conventional wide area circumferential ablation (WACA) pulmonary vein isolation will be performed using a contact-force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation.
15996307|NCT02918383|Diagnostic Test|Indocyanin Green Dye (ICG)|
15996308|NCT02918370|Drug|Aripiprazole|Aripiprazole is an atypical antipsychotic drug that is used to treat mental/mood disorders. It works to restore the balance of neurotransmitters.
15996309|NCT02918370|Drug|Placebo|Inactive ingredient matching the active comparators in appearance.
15996310|NCT02918357|Drug|Ga-68 labeled PSMA-11 PET|Patients will be imaged using Ga-68 labeled PSMA-11 PET to determine if the presence of metastatic disease. Prostate Specific Membrane Antigen (PSMA) is a protein expressed on prostate cancer cells that can be imaged using small molecules that target this protocol.
15996311|NCT02918344|Other|Hydroset|Calcium phosphate paste is used in mandibular lengthening surgery to avoid an unaesthetic notching at the lower border and to help stabilize the segments when osteosynthesis slippage is feared for.
15996312|NCT02918344|Procedure|Standard sagittal split osteotomy|The sagittal split osteotomy (SSO) is commonly used to correct dentofacial discrepancies.
15996313|NCT02918331|Drug|Daratumumab (16 mg/kg)|Daratumumab (16 mg/kg) will be administered by IV infusion to all participants once every week for 8 weeks; then once every other week for 16 weeks; thereafter once every 4 weeks until documented progression, unacceptable toxicity or study end.
15996314|NCT02918331|Drug|Lenalidomide|Participants will receive lenalidomide 25 mg orally on Days 1 through 21 of each 28 day cycle. Participants with creatinine clearance (CrCl) between 30 and 60 milliLitre (mL)/minute (min) will receive lenalidomide 10 mg every 24 hours.
15996315|NCT02918331|Drug|Dexamethasone|Participants will receive dexamethasone 40 mg weekly, at day 1, 8, 15, 22 of each cycle.
15996316|NCT02918318|Drug|Placebo|Participant will receive 1 spray of placebo to each nostril at 0 minute, 5 minutes and 10 minutes.
15996317|NCT02918318|Drug|Intranasal esketamine (28 mg)|Participant will receive 1 spray of Esketamine to each nostril at 0 minute and placebo at 5 minutes and 10 minutes.
15996318|NCT02918318|Drug|Intranasal esketamine (56 mg)|Participant will receive 1 spray of Esketamine to each nostril at 0 minute, 5 minutes and placebo at 10 minutes.
15996410|NCT02917655|Behavioral|Numerical Rating Scales (NRS)|Answer NRS at baseline, 6, 12 and 24 months.
15996319|NCT02918318|Drug|Intranasal esketamine (84 mg)|Participant will receive 1 spray of Esketamine to each nostril at 0 minute, 5 minutes and 10 minutes.
15996320|NCT02918305|Device|PRDS-001 Renal Denervation Ultrasound System|
15996321|NCT02918305|Procedure|Sham Procedure|
15996322|NCT02918292|Drug|Antithymocyte Globulin (ATG)|Administration of ATG will be 0.5 mg/kg IV on Day -9 over 6 hours and 2 mg/kg IV on Days -8 and -7 over 4 hours.
15996323|NCT02918292|Drug|Fludarabine|Fludarabine dose will be 30 mg/m^2 IV daily for 5 days from Day -6 to Day -2.
15996324|NCT02918292|Drug|Cyclophosphamide|Cyclophosphamide dose will be 14.5 mg/kg IV daily for 2 days (Day -6 to Day -5) prior to transplantation and 50 mg/kg IV daily for 2 days (Day +3 to Day +4) after transplantation.
15996325|NCT02918292|Radiation|Total Body Irradiation (TBI)|TBI is to be delivered in a single dose of 200 cGy on Day -1.
15996326|NCT02918292|Procedure|Haplo HSCT|Eligible patients without a fully matched related or unrelated donor available will undergo haploidentical bone marrow transplant.
15996327|NCT02918292|Drug|Tacrolimus|Tacrolimus should be started on Day +5 and administered to maintain a level of 10-15 ng/mL.
15996328|NCT02918292|Drug|Mycophenolate mofetil (MMF)|MMF dose will be 15 mg/kg PO three times a day (TID) up to 1 gm TID (or IV equivalent) starting on Day +5.
15996329|NCT02918292|Drug|G-CSF|G-CSF will be given IV or SQ starting on Day +5 at 5 mcg/kg/day until ANC is > 1500 for 3 days.
15996330|NCT02918279|Drug|Liraglutide|Administered once daily subcutaneously (s.c., under the skin)
15996331|NCT02918279|Drug|Placebo|Administered once daily subcutaneously (s.c., under the skin)
15996332|NCT02918266|Drug|Scopolamine|Scopolamine subcutaneous injection
15996333|NCT02918266|Drug|TAK-071|TAK-071 DIC
15996334|NCT02918266|Drug|Donepezil|Donepezil over-encapsulated tablet
15996335|NCT02918266|Drug|Scopolamine Placebo|Scopolamine placebo-matching subcutaneous injection
15996336|NCT02918266|Drug|TAK-071 Placebo|TAK-071 placebo-matching DIC
15996337|NCT02918266|Drug|Donepezil Placebo|Donepezil placebo-matching over-encapsulated tablet
15996338|NCT02918253|Radiation|targeted focal HDR brachytherapy|
15996339|NCT02918253|Radiation|Whole-gland HDR Brachytherapy|Control/Standard of Care
15996340|NCT02918240|Procedure|Appointment intervals|
15996341|NCT02918240|Device|fixed orthodontic braces|
15996342|NCT02918227|Procedure|Search retrograde ejaculation|Sperm count (spz) after orgasm achieved by masturbation will be measured, corresponding to the sum of spz collected in the ejaculate (E) and the first urine after orgasm (U). These measures will be made before surgery (E1 and U1) and after surgery (E2 and U2). The values E1, E2, U1 and U2 will be achieved by multiplying the concentration of spz per unit volume by the total volume of collection.
15996343|NCT02918201|Drug|Tranexamic Acid|TXA 25 mg/ml applied topically to moisten the wound
15996344|NCT02918201|Drug|saline|Saline solution (0.9% NaCl) applied topically to moisten the wound
15996345|NCT02918188|Drug|Hydrogen|Patients will receive hydrogen-rich water orally (500mL three times one day, 0.6mM)
15996346|NCT02918175|Behavioral|mHealth|Personalized step count feedback and medication teaching tool.
15996347|NCT02918162|Drug|Pembrolizumab|Pembrolizumab dosed IV at 200mg every 21 days per cycle.
15996348|NCT02918162|Drug|Standard of care chemotherapy regimen|"Standard regimen containing at least a platinum and Fluorouracil (5-FU) agent (per National Comprehensive Cancer Network guidelines) - such as Doublet or Triplet chemotherapy with capecitabine, oxaliplatin, and epirubicin (optional) (21 day cycle). Epirubicin can be excluded at the discretion of the treating physician.
~Example:
~Oxaliplatin dosed IV at 130 mg/m2 every 21 days per cycle. Capecitabine dosed orally at 625mg/m2 twice a day daily."
15996349|NCT02918149|Other|Palpation Landmark Technique|"Clinician will follow routine palpation landmark technique procedure for LP, such as identification of anatomic landmarks by palpation (i.e., superior borders of the posterior iliac crest lies in parallel with L4 spinous process). Palpation will be followed by blind stick of the appropriate inter-spinous process space. The study member will have 2 attempts to complete the LP. A successful attempt is obtaining cerebrospinal fluid."
15996350|NCT02918149|Device|Ultrasound-Assisted Technique LP|"Clinician will use an ultrasound-assisted technique to perform the LP. The Phillips CX50 ultrasound machine is an FDA approved device and will be used in accordance with its approved labeling. Spinal ultrasound will be performed using a linear high-frequency transducer to locate and mark the termination of the conus medullaris, the narrowing of the spinal canal, and the midline to delineate a safe zone. The study team member will have 2 attempts to complete the LP. A successful attempt is obtaining cerebrospinal fluid."
15996351|NCT02918136|Biological|Adipose derived regenerative cells|
15996352|NCT02918136|Drug|Cortisone Injectable|
15996353|NCT02918123|Biological|FURESTEM-CD Inj.|Patients will be treated FURESTEM-CD Inj. Subcutaneous injection
15996354|NCT02918110|Drug|Misoprostol|Women needed to be induced will get orally administrated solution of misoprostol (Cytotec®) or vaginal slow release misoprostol (Misodel®)
15996355|NCT02918097|Drug|Lithium Carbonate|
15996356|NCT02918097|Drug|Sertraline|
15996357|NCT02918097|Drug|Nortriptyline|
15996358|NCT02918097|Drug|Risperidone|
15996359|NCT02918084|Drug|Anastrozole or Letrozole or Exemestane|Adjuvant chemotherapy → Anastrozole or Letrozole or Exemestane once a day for 5 years (sequential arm)
15996360|NCT02918084|Drug|Anastrozole or Letrozole or Exemestane|Adjuvant chemotherapy + Anastrozole or Letrozole or Exemestane once a day for 5 years (concurrent arm)
15996361|NCT02918071|Biological|Benralizumab|Benralizumab administered subcutaneously every 4 weeks
15996362|NCT02918058|Other|MedSafer|MedSafer is an electronic tool for the treating team (physician and pharmacists) to facilitate medication deprescription. MedSafer can identify potentially inappropriate medication use and communicate the risk of adverse drug events to the treating team.
15996363|NCT02918045|Device|HemCon Dental Dressing|The Hemcon Dental Dressing is an oral wound dressing made of chitosan.
15996364|NCT02918045|Device|Oxidized Cellulose Gauze|A common hemostatic measure after dental extractions placed into the extraction socket.
15996365|NCT02918019|Drug|MSTT1041A|MSTT1041A will be administered as subcutaneous injections.
15996366|NCT02918019|Drug|Placebo|Placebo matched with MSTT1041A.
15996367|NCT02918006|Biological|VXA-A1.1|Enteric coated oral vaccine tablet
15996368|NCT02918006|Biological|Fluzone®|Fluzone Quadravalent (Fluzone®) influenza vaccine (QIV) suspension for intramuscular (IM) injection
15996369|NCT02918006|Other|Placebo Tablets|Placebo tablets similar in size, color and number to the active oral tablet vaccine drug product
15996370|NCT02918006|Other|Saline Solution for Placebo IM Injection|
15996371|NCT02917993|Drug|Itacitinib|In Phase 1, itacitinib at a protocol-defined starting dose, with subsequent dose escalation based on protocol-specific criteria. In Phase 2, itacitinib at the recommended dose from Phase 1.
15996372|NCT02917993|Drug|Osimertinib|Osimertinib 80 mg once daily (QD)
15996373|NCT02917967|Drug|Botulinum toxin injection|"BoNT-A will be injected into two hamstring and/or gastrocnemius muscles under the guidance of ultrasonography or electrical stimulation.
~Maximal total dose and dose regimen for each muscle would follow the recommendation of international consensus.
~A. Semitendinosus 5 to 7.5 units/kg of body weight B. Semimembranosus 5 to 7.5 units/kg of body weight C. Gastrocnemius 10 units/kg of body weight D. Maximal total dose per patient : unilateral injection 500 units, bilateral injection 1,000 units E. The dosage of two hamstring muscles will depend on the severity of spasticity and gait abnormalities of children with CP"
15996374|NCT02917954|Device|ePRO Tool Intervention|The ePRO tool includes two features: 1) My Goal Tracker and 2) Health Journal. My Goal Tracker allows patients and providers to collaboratively create goal-oriented patient care-plans, and helps patients to track outcomes related to their goals using a mobile device. The Health Journal allows patients, their caregivers and primary care providers to monitor patients' symptoms and outcomes.
15996375|NCT02917941|Drug|Ixazomib|Ixazomib capsules
15996376|NCT02917941|Drug|Lenalidomide|Lenalidomide capsules
15996377|NCT02917941|Drug|Dexamethasone|Dexamethasone Tablets
15996378|NCT02917928|Dietary Supplement|carnosine|Each participant will be given a daily oral dose 2 g of carnosine (4 tablets of 500mg each) for 14 weeks
15996379|NCT02917928|Drug|Placebo|Each participant will be given a daily oral dose 2 g of placebo (4 tablets of 500mg each) for 14 weeks
15996380|NCT02917915|Other|Canadian Standardized PR|Patients attend pulmonary rehabilitation (PR) 3 days per week for 6 weeks or 2 days per week for 8 weeks. Patients receive 2 hours of exercise training (aerobic and resistance) and 1 hour of education designed to promote self-management. In this intervention patients will receive the New Canadian Standardized PR educational approach (experimental).
15996381|NCT02917915|Other|Traditional PR|Patients attend pulmonary rehabilitation (PR) 3 days per week for 6 weeks or 2 days per week for 8 weeks. Patients receive 2 hours of exercise training (aerobic and resistance) and 1 hour of education designed to promote self-management. In this intervention patients will receive the Traditional PR education approach (active comparator).
15996382|NCT02917902|Other|Food boxes|Box of approximately 50 pounds of nutritious foods provided by food pantry, including fresh fruits and vegetables as well as shelf-stable items selected for diabetic patients, along with brief education provided by food pantry staff.
15996383|NCT02917889|Drug|Caffeine|Volunteers will consume 300 mg of caffeine in pills fifteen minutes before treadmill aerobic exercise.
15996384|NCT02917889|Drug|Placebo|Volunteers will consume 300 mg of placebo in pills fifteen minutes before treadmill aerobic exercise.
15996385|NCT02917889|Other|Cardiopulmonary test|"assessment of the maximum oxygen consumption (VO2max) on a treadmill (Inbrasport / Millennium), using Buce protocol.
~."
15996386|NCT02917889|Other|Treadmill aerobic exercise|30 mim of aerobic exercise (5 minutes at speed of 5.0 km/h for warming-up followed by 25 minutes at 60% of VO2max ).
15996387|NCT02917863|Drug|L-Thyroxine (tablet, per os)|
15996388|NCT02917863|Drug|L-Thyroxine (oral drops, solution)|
15996389|NCT02917850|Procedure|Isokinetic hip flexors strengthening|Isokinetic excentric strengthening of paretic hip flexors, 3/w during 6 weeks, in addition to conventional rehabilitation 7/w.
15996390|NCT02917850|Procedure|Conventional rehabilitation|Conventional rehabilitation 10/w during 6 weeks
15996391|NCT02917837|Other|Usual QCNL DI utilization report|See arm descriptions.
15996392|NCT02917837|Other|New DI utilization report|See arm descriptions.
15996393|NCT02917837|Other|Detailing|In-person detailing, usually with a small group of family physicians and a peer (physician) facilitator to discuss the topic over a 30-60 minute period.
15996394|NCT02917824|Device|High-intensity IMT|30 breaths at 50% of the maximal inspiratory pressure, twice daily for 6 weeks
15996395|NCT02917824|Device|Low-intensity IMT|30 breaths at 15% of the maximal inspiratory pressure, twice daily for 6 weeks
15996396|NCT02917798|Behavioral|Assessments|
15996397|NCT02917785|Device|Karman curettage|
15996398|NCT02917772|Biological|Nivolumab/Ipilimumab|"Induction: Mono-Therapy with Nivolumab (240 mg i.V. / Q2W x 8)
~If CR/PR: Nivolumab Maintenance Mono-Therapy (240 mg i.V. / Q2W)
~If SD/PD: Nivolumab/Ipilimumab Boost 1+2-Combination Therapy (Nivo 3 mg/kg i.V. and Ipi 1 mg/kg i.V. / Q3W x 2)
~If CR/PR: Nivolumab Maintenance Mono-Therapy (240 mg i.V. / Q2W)
~If SD/PD: Nivolumab/Ipilimumab Boost 3+4-Combination Therapy (Nivo 3 mg/kg i.V. and Ipi 1 mg/kg i.V. / Q3W x 2)
~If CR/PR/SD: Nivolumab Maintenance Mono-Therapy (240 mg i.V. / Q2W)"
15996399|NCT02917746|Drug|Imiquimod|Patients in this group are treated with vaginal imiquimod cream during 16 weeks. A control colposcopy with diagnostic biopsies will be performed after 10 weeks to rule out disease progression. A final colposcopy with diagnostic biopsies will be performed after 20 weeks to evaluate disease efficacy.
15996400|NCT02917746|Procedure|Large Loop Excision of the Transformation Zone|Patients in this group are treated with LLETZ.
15996401|NCT02917733|Drug|LY3039478|Administered orally
15996402|NCT02917720|Other|TKI discontinuation|2nd or 3rd TKI stop after pre-treatment with nilotinib.
15996403|NCT02917720|Drug|nilotinib|Pre-treatment with nilotinib 300 mg/bid for 2 years
15996404|NCT02917707|Other|normal colorectal tissues|The investigators will extract total protein, DNA and RNA from these groups.
15996405|NCT02917681|Other|Two intrathecal MSC injections|
15996406|NCT02917668|Other|FreeO2|Oxygen delivery automatically titrated by a closed-loop system that adjusts the oxygen flow based on the patient's real-time SpO2 and a programed SpO2 target of 90 %
15996407|NCT02917668|Other|Usual care|Oxygen delivery manually titrated by the nursing staff for a SpO2 target of > or = 95 %
15996408|NCT02917655|Behavioral|Womac|Answer WOMAC at baseline, 6, 12 and 24 months.
15996409|NCT02917655|Behavioral|Lequesne|Answer Lequesne at baseline, 6, 12 and 24 months.
15996411|NCT02917655|Behavioral|IPAQ|Answer IPAQ at baseline, 6, 12 and 24 months.
15996412|NCT02917655|Behavioral|STS30|Perform the STS30 at baseline, 6, 12 and 24 months.
15996413|NCT02917655|Behavioral|TUG|Perform the TUG at baseline, 6, 12 and 24 months.
15996414|NCT02917655|Behavioral|Six-minute Test|Perform the six-minute test at baseline, 6, 12 and 24 months.
15996415|NCT02917655|Behavioral|Two days of lectures|Participate in two days of classes about KOA, with the seven teams (orthopedics, psychology, physical therapy and fitness, occupational therapy, social workers and nutritionist).
15996416|NCT02917655|Behavioral|Session with the psychologists|Participate in a extra session group with the psychology team about their experiences with the program
15996417|NCT02917655|Behavioral|Sessions with the physical therapy team|Participate in a extra session group with the physical therapists
15996418|NCT02917655|Behavioral|Sessions with the physical educators team|Participate in a extra session group with the physical educators
15996419|NCT02917655|Behavioral|Nutritional habits to be improved|Attend 3 extra meetings about nutrition.
15996420|NCT02917655|Behavioral|Tampa Scale for Kinesiophobia (TSK)|Answer Tampa Scale for Kinesiophobia (TSK) at baseline, 6 months, 12 and 24 months.
15996421|NCT02917642|Device|Ultrasonic Irrigation|Passive Ultrasonic Irrigation is based on the transmission of acoustic energy through the irrigant by a stainless steel wire or endodontic file
15996422|NCT02917642|Device|Non-Ultrasonic Irrigation|Syringe and needle irrigation with no-ultrasonic activation
15996423|NCT02917629|Other|Laboratory Biomarker Analysis|Correlative studies
15996424|NCT02917629|Drug|Metformide Hydrochloride/Pioglitazone Hydrochloride Extended-Release Tablet|Given PO
15996425|NCT02917629|Other|Pharmacological Study|Correlative studies
15996426|NCT02917629|Other|Placebo|Given PO
15996427|NCT02917616|Other|Alkaline drinking-water|
15996428|NCT02917616|Other|Neutral drinking-water|
15996429|NCT02917603|Behavioral|Web Conferencing|Individuals will communicate with the nursing home team via web conferencing during quarterly care conference
15996430|NCT02917590|Other|Dual-task obstacle crossing training|Obstacle crossing simultaneously a color word stroop task training
15996431|NCT02917590|Other|Single-task obstacle crossing training|Obstacle crossing training
15996432|NCT02917577|Biological|Avaxim Pediatric®|2 doses (0.5 mL each) 6 months apart of Avaxim Pediatric® vaccine.
15996433|NCT02917577|Biological|Avaxim ® (adult)|2 doses (0.5 mL each) 6 months apart of Avaxim ® (adult) vaccine.
15996434|NCT02917564|Drug|Triamcinolone Acetonide 1 ml of 40 mg/mL suspension|After preparation, Triamcinolone Acetonide 1 ml of 40 mg/mL suspension is injected through the superotemporal conjunctival fornix using a 25 Gauge needle, 5/8 inch length on a 3 ml syringe, following the contour of the globe with the needle, external to sclera for the full length of the needle such that the needle tip is ultimately positioned immediately posterior to the macula with the bevel down.
15996435|NCT02917564|Other|Sham - Participants will not recieve the Triamcinolone Acetonide|Patients will be given a sham.
15996436|NCT02917551|Other|7 days of adequate antibiotic treatment|
15996437|NCT02917551|Other|14 days of adequate antibiotic treatment|
15996438|NCT02917538|Procedure|RFA|Both groups will receive radiofrequency ablation treatment
15996439|NCT02917525|Dietary Supplement|Vitamin K2|
15996440|NCT02917525|Other|Placebo|
15996441|NCT02917512|Drug|HU00701|Cyclosporine 0.01% + 3% trehalose
15996442|NCT02917512|Drug|HU007|Cyclosporine 0.02% + 3% trehalose
15996443|NCT02917512|Drug|Restasis|Cyclosporine 0.05%
15996444|NCT02917512|Drug|Placebo|Vehicle
15996445|NCT02917499|Device|TMS|Transcranial magnetic stimulation
15996446|NCT02917486|Other|blood sample|
15996447|NCT02917473|Behavioral|In-person counseling|"In-person counseling
~Sun protection"
15996448|NCT02917473|Behavioral|Written advice|Written advice
15996449|NCT02917473|Behavioral|Medical skin screening|Medical skin screening
15996450|NCT02917460|Genetic|Genomic sequencing and molecular diagnostic results, if any|Samples will be stored in the pediatric genomic Biorepository. A subset of samples will undergo genetic/genomic analysis.
15996451|NCT02917447|Behavioral|DESTRESS-WV|This is an online intervention for PTSD tailored for women Veterans. The intervention is based on cognitive behavioral therapy (CBT). The goal of CBT is to help people recognize and address their thoughts and behaviors in positive ways with the aim of improving their ability to function as well as possible in their lives. Participants will be asked to log on to the website twice per week for about 30-60 minutes each time. Homework assignments will include stress management skills that participants will be asked to practice and apply. A study coach will call each participant once a week for 8 weeks for about 15 minutes to review their progress with the program.
15996452|NCT02917447|Behavioral|Phone Monitoring|A study coach will call participants once a week for 8 weeks for approximately 15 minutes. The coach will assess participants' PTSD symptoms and safety. She will encourage participants to use the time on the call to discuss any current life issues or problems that they would like. Active listening and rephrasing will be used, while teaching cognitive-behavioral strategies will be avoided.
15996453|NCT02917434|Dietary Supplement|Very Low Energy Diet (VLED)|Very Low Energy Diet (VLED), divided into 4 daily doses, gives any intake of 640 calories per day together with the recommended doses of vitamins and minerals. During an initial period of 12 weeks the patients only consume VLED. After the strict period food is successively reintroduced during a period of 18 weeks.
15996454|NCT02917421|Radiation|Radiation|(Post-segmental Mastectomy, post-mastectomy and Post-mastectomy with expanders or final reconstruction): Prone whole breast or chest wall 3D-CRT or IMRT at 2.7 Gy X 15 fractions (40.50 Gy) with a concomitant boost of 0.50 Gy (7.5 Gy) to the original tumor bed in post-segmental mastectomy patients or mastectomy scar in post-mastectomy patients. Patients who have undergone reconstruction will not receive concomitant boost.
15996455|NCT02917395|Device|echocardiography|Tow echo examination, few hours apart, that includes strain rate will be done to each patient. The first, after taking the regular medical treatment excluding disopyramide and the last one after taking the disopyramide.
15996456|NCT02917369|Other|Normal lung tissue|The investigators will extract total protein, DNA and RNA from LCLC patients.
15996480|NCT02917200|Device|DAV132|Oral route
15996481|NCT02917200|Other|Negative control|Oral route
15996457|NCT02917356|Other|Spiritual laying on of hands (SP)|"The SP will be applied after physical therapy (kinesiotherapy). Spiritual healers from Spiritism will perform the SP. In order to produce a culturally acceptable environment, the Spiritist therapists will 'prepare' the environment by praying for 5 minutes. The Spiritist therapists will hold both hands 10-15 cm above the patients' head. Then, they will longitudinally lower their hands starting from the patients' head towards their legs, for four times. Subsequently, the therapists shall lay their hands on patients' head and on their knees. The therapists will remain silent during these procedures and try to 'heal' the patients. The subjects will remain in a seated position, blindfolded with dark-blinded goggles, and will receive the following verbal command: Relax and calm your mind."
15996458|NCT02917356|Other|Non-spiritual Laying on of Hands|"The non-spiritual laying on of hands will be applied after physical therapy (kinesiotherapy), for 5 minutes, without touching the patients and without 'preparing' the environment. They will hold their hands 10-15 cm above patient's head and will focus on healing the patients. They will visualize the following sentence: I want you to heal; without saying prayers or invocations. The subjects will remain in a seated position, blindfolded with dark-blinded goggles, and will receive the following verbal command: Relax and calm your mind."
15996459|NCT02917356|Other|Control group|"The patients will be subjected to physical therapy (kinesiotherapy), only. However, they will be accompanied by people who will stay in the room and move slowly and randomly in order to sham the presence of someone performing the laying on of hands. However, they will not perform the laying on of hands. These people will not focus on healing the patients and they will be asked to mentally count 5 minutes while they are with the patients. The subjects will remain in a seated position, blindfolded with dark-blinded goggles, and will receive the following verbal command: Relax and calm your mind."
15996460|NCT02917343|Behavioral|mirror therapy and repetitive task training|
15996461|NCT02917330|Other|Stretching and progressive strength training|Intervention implemented by local physiotherapist.16 weeks, three treatment sessions each week. Minimum pause between two treatment sessions is one day. Week 1 and 2: To assure the correct dosage in each exercise and a satisfactory education of the session done at home, all three sessions will be implemented with the physiotherapist the first two weeks. From week 3: Two treatment/training sessions with the physiotherapist and one shorter training session at home.
15996462|NCT02917304|Biological|GC3110A vaccine|0.5mL, Intramuscular
15996463|NCT02917291|Drug|FAB117-HC|(Ph 1) Intramedullary administration. Open label dose escalation, 3 patients in cohort 1 (20 million cells) and 5 patients in cohort 2 (40 million cells)
15996464|NCT02917291|Other|Control group|(Ph 2) No treatment will be administered
15996465|NCT02917291|Drug|FAB117-HC|(Ph 2) Intramedullary administration of the maximum tolerated dose (20 or 40 million cells)
15996467|NCT02917265|Device|TENS for vagus stimulation|TENS electrodes are applied on an area of the external ear innervated by the auricular branch of the vagus nerve.
15996468|NCT02917265|Device|TENS for sham stimulation|TENS electrodes are applied on an area of the external ear devoid of vagus innervation.
15996469|NCT02917252|Other|3-hydroxybuturate|Drink of ketone bodies
15996470|NCT02917252|Other|Placebo|Drink of saline
15996471|NCT02917226|Other|Clinical decision support and monitoring system|
15996472|NCT02917213|Other|Doppler echocardiogram exam|A complete echocardiographic study will be performed in the first 24 hours, and after a week and 6 months after enrollment. The echocardiographic images will be acquired as clinically recommended. The protocol will include the acquisition of 1) 2D images in parasternal axis long and short axis; 2) 2D and Doppler tissue images in the apical planes of 4, 2 and 3 chambers; 3) Pulsed, continuous and color Doppler M (DCMM) of transmitral LV flow and LV ejection; 4) 3-Chamber apical plane with and without color Doppler; and 5) 3D LV images. DCMM images will be obtained from the apical window using 4 and 5 chamber planes. Blood flow velocity will be obtained using Color and Gray mode in the 3 chamber view during 5-10 beats in apnea.
15996473|NCT02917213|Other|Carotid duplex ultrasound exam|A B-mode and Doppler ultrasound study will be performed using a linear probe 9L (9 MHz) for the evaluation of the common carotid artery bulb, the carotid bifurcation and the internal carotid during 24 h after enrollment. Intima-media thickness will be measured. Turbulent flow velocities in the area of stenosis will be measured by Doppler. The criteria used to grade the severity of carotid atherosclerotic disease will follow the Consensus Conference of the Society of Radiologist in Ultrasound 2003.
15996474|NCT02917213|Other|Cardiac MRI|"A cardiac MR will be acquired a week and 6 months after enrollment. The protocol includes the following sequences: cine mode of short axes from LV base to apex, 2-3-4 chambers and STIR +T2 sequence. Perfusion during the administration of a bolus of 0.05 mmol / kg Gadovist®. 3D sequence of late enhancement of inversion-recovery. Images will be acquired after 10 min of the administration of a total of 0.2 mmol / g of Gadovist®. Intraventricular thrombosis will be monitored. Phase contrast sequences in three orthogonal planes will be acquired. Morphological parameters of LV function (LVEF), contractility (Wall Motion Score ), sphericity index, infarct size, area at risk, edema, microvascular obstruction and first-pass perfusion will be obtained."
15996475|NCT02917213|Other|Brain MRI|A brain MR will be acquired a week and 6 months after enrollment. Axial, sagittal and coronal spin echo sequence in T1, axial images in diffusion sequences (DWI), enhanced spin echo T2 and FLAIR (fluid-attenuated inversion recovery) sequences shall be obtained. A cerebral infarction will be positive when finding the presence of a focal lesion of> 3 mm in diameter that meets one of these three characteristics: (1) high signal on isotropic DWI images and low signal on the apparent coefficient map Broadcast (ADC). (2) Cavitary lesion hyperintense on T2, with no signal (or low) in the FLAIR sequence. (3) Hyperintense lesion T2 / T1 hypointense with prior distribution defect known or new in a follow-up study.
15996476|NCT02917213|Procedure|Reveal LINQ insertable cardiac monitoring system|A Reveal LINQ insertable cardiac monitoring system will be implanted following 1:1 patient unblinded randomization (device:no device). The device will be interrogated at a week after implantation and at 6 months, or if symptoms (palpitations or syncope) have activated the device memory.
15996477|NCT02917213|Other|Coagulation blood test|5 ml of peripheral blood will be obtained for assessment of prothrombotic markers at enrollment, at one week and 6 months after enrollment.
15996478|NCT02917213|Other|Transcranial Doppler monitoring|A Transcranial Doppler monitoring will be performed in the first 24 hours after enrollment in order to detect High Intensity Transient Signals (HITs).
15996479|NCT02917200|Drug|Moxifloxacin|Oral route
15996482|NCT02917187|Drug|BIIB074|Administered as specified in the treatment arm
15996483|NCT02917187|Drug|Placebo|Matched placebo
15996484|NCT02917174|Behavioral|Mobile Asthma Management System|Patients in this group use a smartphone app in their asthma self-management.
15996485|NCT02917174|Behavioral|traditional Asthma Management System|Patients in this group use a printed asthma diary in their asthma self-management.
15996486|NCT02917161|Device|Prostatic Artery Embolization (PAE)|PAE is performed 6 weeks before radical prostatectomy
15996487|NCT02917148|Other|Peripheral Venipuncture or Blood draw from Central Line|
15996488|NCT02917135|Device|Angel® Catheter|"The Angel® Catheter is a retrievable inferior vena cava (IVC) filter attached to a multi-lumen central venous access (CVC) catheter. The device is designed to be placed at the bedside in the inferior vena cava, via the femoral vein, for the prevention of pulmonary embolism (PE) and for access to the central venous system.
~The Angel® Catheter is intended for short-term (less than 30 days) vascular access via the femoral vein."
15996492|NCT02917109|Behavioral|LearningRx cognitive training|A clinician will deliver three 90-minute cognitive training sessions per week for 14 weeks. There are 16 different categories of leveled training procedures sequenced in intensity and difficulty for a total of 530 training tasks.
15996493|NCT02917096|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic HCT
15996494|NCT02917096|Drug|Fludarabine|Given IV
15996495|NCT02917096|Drug|Fludarabine Phosphate|Given IV
15996496|NCT02917096|Other|Laboratory Biomarker Analysis|Correlative studies
15996497|NCT02917096|Drug|Melphalan|Given IV
15996498|NCT02917096|Other|Pharmacological Study|Correlative studies
15996499|NCT02917096|Drug|Ruxolitinib|Given PO
15996500|NCT02917096|Drug|Ruxolitinib Phosphate|Given PO
15996501|NCT02917096|Drug|Sirolimus|Given PO
15996502|NCT02917096|Drug|Tacrolimus|Given IV and PO
15996503|NCT02917083|Genetic|CAR T Cells|"Three dose levels will be evaluated based on safety data from our current study of CD30 CAR T cells. Cohorts of three to six patients will be enrolled at each dose level. Each patient will receive one infusion of CAR modified T cells according to the following dosing schedule:
~Dose Level One: 2x10^7 cells/m2. Dose Level Two: 1x10^8 cells/m2. Dose Level Three: 2x10^8 cells/m2."
15996504|NCT02917083|Drug|Cyclophosphamide|Patients who are not post autologous transplant will receive three daily doses of cyclophosphamide (Cy: 500mg/m2/day) finishing at least 48 hours before T cell infusion, but no later than 2 weeks prior to infusion of the cells.
15996505|NCT02917083|Drug|Fludarabine|Patients who are not post autologous transplant will receive fludarabine (Flu: 30mg/m2/day), finishing at least 48 hours before T cell infusion, but no later than 2 weeks prior to infusion of the cells.
15996506|NCT02917070|Other|Patients|In this study we aimed to investigate effect of family history and consanguineous marriage in the development of CKD in the adult Turkish population.
15996507|NCT02917057|Drug|exenatide once weekly|Exenatide treatment in customary clinical care in the USA
15996508|NCT02917057|Drug|basal insulin|basal insulin tretament in the customary clinical care in USA
15996509|NCT02917044|Procedure|Atrial Fibrillation Ablation|Procedure involving catheter ablation to produce pulmonary vein isolation. Pulmonary veins are isolated by assessing electrograms circumferentially around the PV using the Orion catheter.
15996510|NCT02917044|Device|Catheters used to isolate pulmonary veins|Catheters transiently inserted into body via femoral veins in order to produce pulmonary vein isolation. These catheters are the same in each arm and comprise the Orion catheter (Boston Scientific) and the Tacticath (St Jude) which are used to produce pulmonary vein isolation and which are approved for use in standard EP procedures by the relevant authorities (CE marked). It is merely the protocol by which they are used that iffers in the two arms.
15996511|NCT02917044|Procedure|Atrial Fibrillation Ablation with HD mapping to isolate PVs|Procedure involving catheter ablation to produce pulmonary vein isolation. Pulmonary veins are isolated by use of electroanatomical mapping with the Orion catheter around the sites ablation in order to target points of breakthrough.
15996512|NCT02917044|Device|Rhythmia HD mapping|Mapping activation patterns using the Rhythmia system in conjunction with the Orion catheter
15996513|NCT02917031|Drug|Saxagliptin|5 mg or 2.5 mg, plain, yellow, biconvex, round, film-coated tablet
15996514|NCT02917031|Drug|Sitagliptin|50 mg or 100 mg, gray capsule
15996515|NCT02917031|Drug|Placebo to match saxagliptin|2.5 mg or 5 mg, plain, yellow, biconvex, round, film-coated tablet
15996516|NCT02917031|Drug|Placebo to match sitagliptin|50 mg or 100 mg, gray capsule
15996517|NCT02917018|Drug|Dexmedetomidine|Group I will receive 1 ug/kg, group II will receive 0.75 ug/kg and group III will receive 0.5 ug/kg) diluted to 50 ml NaCl 0.9% by syringe pump over 20 minutes before end of surgery.
15996518|NCT02917005|Drug|Palbociclib|CDK 4/6 inhibitor
15996519|NCT02917005|Drug|Exemestane|Aromatase inhibitor
15996520|NCT02917005|Drug|Goserelin|LHRH agonist
15996521|NCT02916992|Radiation|CT scan of the thorax|A low dose CT scan of the thorax (2mSv) wil be performed once.
15996522|NCT02916992|Genetic|blood sample for FLCN mutation analyses|A venous punction in order to withdraw 16ml blood is undertaken once.
15996523|NCT02916979|Drug|Fludarabine|Fludarabine: 30 mg/m2 daily for 5 days
15996524|NCT02916979|Drug|Busulfan|Busulfan: 100 mg/m2 daily for 4 days
15996525|NCT02916979|Biological|Rabbit ATG|"Rabbit ATG:
~Related donors: 1.5 mg/kg daily x 2 days (on days -6 and -5) Unrelated donors: 1.5 mg/kg on day - 6 2 mg/kg on day -5 2.5 mg/kg on day -4"
15996526|NCT02916979|Drug|Methotrexate|"Methotrexate:
~Related donors: 5 mg/m2 on days 1, 3 and 6 Unrelated donors: 5 mg/m2 on days 1, 3, 6 and 11"
15996527|NCT02916966|Other|Patient Registry|Patient Registry
15996676|NCT02915744|Drug|NKTR-102|
15996677|NCT02915744|Drug|Eribulin|
15996678|NCT02915744|Drug|Ixabepilone|
15996528|NCT02916953|Device|AGN1 Femoral Local Osteo-Enhancement Procedure|A procedure that is intended to increase the strength of the proximal femur in individuals with osteoporosis of the femoral neck. Local treatment of the proximal femur with AGN1 is intended to be adjunctive to appropriate systemic therapy and overall osteoporosis management as directed by the patient's treating physicians.
15996529|NCT02916940|Drug|Diprophos|Single subcutaneous injection of Diprophos, in the acute phase.
15996530|NCT02916927|Drug|Ketamine IV Infusion|Ketamine 0.3 mg/kg in 100mL normal saline minibag administered over 15 min and placebo 10 mL normal saline syringe administered over 1 minute.
15996531|NCT02916927|Drug|Ketamine IV push|Ketamine 0.3 mg/kg in 10 mL normal saline syringe administered over 1 minute and placebo 100mL normal saline minibag administered over 15 min.
15996532|NCT02916914|Other|Q2 feeding|Infants are going to be fed every 2 hours
15996533|NCT02916901|Drug|CKD-519 200mg|
15996534|NCT02916901|Drug|Placebo|
15996535|NCT02916888|Other|Care provided by general pediatrician|Standard of care management of atopic dermatitis by a general pediatrician.
15996536|NCT02916888|Other|Care provided by pediatric dermatologist|Standard of care management of atopic dermatitis by a pediatric dermatologist.
15996537|NCT02916862|Dietary Supplement|Soluble Corn Fiber (SCF) without Calcium|Participants will consume a supplement with 12 g/day of SCF for 12 months
15996538|NCT02916862|Combination Product|Soluble Corn Fiber (SCF) + Calcium|Participants will consume a supplement with 12 g/day of SCF + calcium carbonate (600 mg/day) for 12 months
15996539|NCT02916862|Dietary Supplement|Placebo|Participants will consume a supplement without SCF or calcium carbonate for 12 months
15996540|NCT02916862|Combination Product|Placebo + calcium|Participants will consume a supplement without SCF + calcium carbonate (600 mg/day) for 12 months
15996541|NCT02916849|Other|Safe Step|Strength and balance exercise-digital version
15996542|NCT02916849|Other|OEP|Strength and balance exercise -paper version
15996543|NCT02916836|Other|therapeutic drug conciliation sheet (TDC)|Use of therapeutic drug conciliation sheet (TDC)
15996544|NCT02916836|Other|No Use of therapeutic drug conciliation sheet (TDC)|
15996545|NCT02916810|Device|Active rTMS stimulation|Multiple trains of active transcranial magnetic stimulation in a day, for multiple days.
15996546|NCT02916810|Device|Sham rTMS stimulation|Multiple trains of sham transcranial magnetic stimulation in a day, for multiple days.
15996547|NCT02916797|Other|Stepping training with feedback|Stepping training with the use of external feedback. The subjects will be instructed to shift/take their body-weight onto the affected leg until the green zone of the displayed section is lighting and a beep sound to alarm the subjects to step the non-affected leg forward and backward as much as they can.
15996548|NCT02916771|Drug|Ixazomib|Oral, proteasome inhibitor
15996549|NCT02916771|Drug|Lenalidomide|Oral, immunomodulatory agent
15996550|NCT02916771|Drug|Dexamethasone|Oral, steroid
15996551|NCT02916758|Other|Let's Go Community Mobility Program|Four week multi-modal education and experiential program to improve community mobilty
15996552|NCT02916745|Drug|Porfimer sodium|After injection of porfimer sodium (Photofrin®), a flexible bronchoscopy with navigation guidance will be performed to confirm the location and the size of the lesion with the use of radial probe endobronchial ultrasonography (REBUS). A light dose of 200 J/cm of diffuser length will be delivered.
15996553|NCT02916745|Device|Fiber optic|A fiber optic diffuser length matching the tumor length will be placed in the lesion under fluoroscopy guidance.
15996554|NCT02916719|Device|MRI|MRI examination after the neo-adjuvant radiotherapy, but before the surgical treatment
15996555|NCT02916706|Drug|Teneligliptin 20mg|
15996556|NCT02916706|Drug|Placebo|
15996557|NCT02916693|Drug|Mirabegron|FDA-approved, beta 3 agonist for over active bladder
15996558|NCT02916680|Procedure|Pancreatic islet transplantation in the anterior chamber|Transplantation of allogeneic pancreatic islet cells into the anterior chamber of a severely visual impaired diabetic human eye
15996559|NCT02916667|Other|dietary guidelines|dietary guidelines will include chrono- nutrition diet plan
15996560|NCT02916654|Dietary Supplement|sucrosomial iron|administration of sucrosomial iron
15996561|NCT02916654|Drug|Sulphate iron|administration of sulphate iron
15996562|NCT02916641|Drug|Fuzhenghuayu|
15996563|NCT02916641|Drug|UDCA|
15996564|NCT02916628|Behavioral|group counseling|Group counseling with positive psychology and motivational interviewing was undertaken once per week for 6 weeks.
15996565|NCT02916628|Device|Auricular acupressure|Auricular acupressure using acupellets was performed for 6 weeks continuously
15996566|NCT02916628|Device|placebo acupressure|Placebo acupellets were prepared without metal projections, and placed on both sides in the same areas of the ear as the active condition.
15996567|NCT02916615|Other|High nitrate vegetables|vegetables naturally high in nitrate
15996568|NCT02916615|Dietary Supplement|Low nitrate vegetables + nitrate|pill containing KNO3
15996569|NCT02916615|Other|Low nitrate vegetables|vegetables naturally low in nitrate
15996570|NCT02916602|Drug|HCP1401|amlodipine, Losartan, Chlorthalidone FDC
15996571|NCT02916602|Drug|HCP0605|amlodipine, Losartan FDC
15996572|NCT02916589|Dietary Supplement|Diet|
15996573|NCT02916576|Device|Blood-Glucose Monitoring Systems for self-testing|"This is a user performance study, that is intended to show whether people with diabetes are able to obtain accurate measurement results with a blood glucose monitoring system (BGMS).
~The subjects' measurement technique (e.g. applying blood onto the system reagent, reading the result) will be observed and documented by study personnel.
~Immediately after the measurement by the subject, the study personnel will perform a measurement with the same test meter.
~Measurement results obtained by the subjects with the BGMS will be compared to measurement results obtained with the comparison method.
~Sample collection for the comparison measurement will be performed by study personnel within 5 min after the subject's measurement with the test meter.
~The samples will be collected from the subjects' skin puncture (if possible), an additional skin puncture (if required) will be documented.
~An additional skin puncture will be performed by study personnel with single-use lancing devices."
15996574|NCT02916563|Device|Blood Glucose Monitoring System Altitude Performance|Performance as assessed against a reference method at an altitude of approximately 10,000 feet.
15996679|NCT02915744|Drug|Vinorelbine|
15996575|NCT02916550|Behavioral|Breathing exercise|Participants will perform a paced breathing intervention (slow breathing) prompted by pseudorandomized remote reminders (scheduled reminders plus non scheduled reminders), through cellular phone application.
15996576|NCT02916537|Drug|CTT1057|Single IV dose (370 MBq, or 10 mCi) of CTT1057 followed by combined PET/MR imaging (prostate + whole body).
15996577|NCT02916537|Procedure|Prostatectomy|Radical prostatectomy with lymph node dissection
15996578|NCT02916524|Behavioral|Semantic Feature Analysis (SFA)|SFA training entails having the speech-language pathologist (SLP) guide the participant through generation of pertinent semantic features for pictured treatment items (e.g., category membership, physical description, location of item in context, action associated with item). Treatment is applied to a set of items in the context of single-subject, multiple baseline designs so that replication of treatment effects could be evaluated within and across participants. Treatment will be administered two times per week until prescribed accuracy levels were met during treatment probes or a maximum number of treatment sessions was completed.
15996579|NCT02916511|Drug|Paclitaxel|paclitaxel 50mg/m2/d, ivgtt over 3 hours, d1, qw*5
15996580|NCT02916511|Drug|Carboplatin|carboplatin AUC=2, ivgtt, d1, qw*5
15996581|NCT02916511|Radiation|Radiotherapy|1.8Gy/d, d1-5/week, 25Fx
15996582|NCT02916498|Device|Boston Scientific's Precision SPECTRA™ Spinal Cord Stimulation System|Spinal cord stimulation for the management of chronic neuropathic pain
15996583|NCT02916485|Device|Bioresorbable scaffold|Percutaneous coronary intervention (PCI)
15996584|NCT02916472|Behavioral|CyberCycling|All exercise training will be performed under the supervision of a qualified exercise trainer certified in Advanced Cardiac Life Support. Participants in the exercise groups will be asked to perform aerobic exercise on a stationary bike ('cybercycle') 3 days per week for 12 weeks. Exercise intensity and duration will be based on a progressive program and adapted, as needed, based on the participants' tolerability. Heart rate will be monitored throughout the exercise session and Rating of Perceived Exertion (RPE) monitored at least every 10 minutes. The target heart rate (THR) zone will be determined using the Karvonen formula.
15996585|NCT02916472|Behavioral|Stretching|Participants randomized to the control condition will receive a progressive resistance training program with TheraBands™ and a stretching program to complete at home 2 days/week for 12 weeks. The resistance band program will include upper body and lower body exercises. Participants will be provided with two different colored resistance bands (lighter colored - easier resistance; darker colored - harder resistance). Participants will start by completing 1-2 sets, 2 days/week with the easier/lighter band for the first 4 weeks, progress to 2-3 sets, 2 days/week with the easier band for the next 4 weeks; and, then, progress to 1-2 sets with the darker/harder band for the last 4 weeks. In addition, all participants in the 'control' condition will be advised to conduct upper body and lower body stretches 2 days/week. All resistance band exercises and stretches will be demonstrated to the participant by the exercise physiologist before the 12 week program begins.
15996586|NCT02916472|Behavioral|Resistance Bands|"Participants randomized to the control condition will receive a progressive resistance training program with TheraBands™ and a stretching program to complete at home 2 days/week for 12 weeks.
~The resistance band program will include upper body and lower body exercises and will be provided with two different colored resistance bands (one lighter colored for easier resistance; one darker colored for a harder resistance). Participants will start by completing 1-2 sets, 2 days/week with the easier/lighter band for the first 4 weeks, progress to 2-3 sets, 2 days/week with the easier band for the next 4 weeks; and, then, progress to 1-2 sets with the darker/harder band for the last 4 weeks. In addition, all participants in the 'control' condition will be advised to conduct upper body and lower body stretches 2 days/week. All resistance band exercises and stretches will be demonstrated to the participants by the exercise physiologist before the 12 week program begins."
15996587|NCT02916459|Device|21G EBUS-TBNA needle|
15996588|NCT02916459|Device|Flexible 19G EBUS-TBNA needle|
15996589|NCT02916446|Biological|Viaskin Peanut 250 mcg|
15996590|NCT02916446|Biological|Placebo|
15996591|NCT02916433|Drug|Octreotide|
15996592|NCT02916420|Drug|Pomalidomide|4mg/day, d1-d21, 28 days per cycle
15996593|NCT02916420|Drug|Dexamethasone|≤70 years,40mg/day; >70 years,20mg/day, d1、d8、d15、d22, 28 days per cycle
15996594|NCT02916407|Drug|Sevoflurane|"Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children.
~General anesthesia will maintained with sevoflurane 2-3 vol%."
15996595|NCT02916407|Drug|Desflurane|"Intravenous ketamine will administrate to the patients for decreasing of separation anxiety of children.
~General anesthesia will maintained with desflurane 6-7vol%."
15996596|NCT02916394|Radiation|68Ga-NODAGA-ZIGF-1R:4：40|No Intervention
15996597|NCT02916381|Procedure|PEC block + General anaesthesia|Patients will receive an ultrasound-guided PEC block after the induction of general anaesthesia.
15996598|NCT02916381|Procedure|General anaesthesia|
15996599|NCT02916355|Drug|Anakinra|Subjects will receive Anakinra infusion and afterwards they will be fed a very fat containing meal, and postprandial fatigue will be measured regularly until 3,5 hour after the meal.
15996600|NCT02916355|Drug|NaCl|subjects will receive NaCl infusion and afterwards they will be fed a very fat containing meal, and postprandial fatigue will be measured regularly until 3,5 hour after the meal.
15996601|NCT02916342|Procedure|Interscalene brachial plexus block|Patients will receive an ultrasound-guided interscalene brachial plexus block before general anaesthesia.
15996602|NCT02916342|Procedure|Supraclavicular-axillary nerve blocks|Patients will receive ultrasound-guided supraclavicular and axillary nerve blocks before general anaesthesia.
15996603|NCT02916329|Other|68Ga-NODAGA-Ac-Cys-ZEGFR:1907|68Ga-NODAGA-Ac-Cys-ZEGFR:1907 (Ac-Cys-ZEGFR:1907 : Ac-CVDNKFNKEMWAAWE EIRNLPNLN GWQMTAFIASLVDDPSQSANLLAEAKKLNDAQAPK-NH2)
15996604|NCT02916316|Drug|R-CHOP with doxorubicin|Chemoimmunotherapy every 21 days for 6 cycles. In unfavourable patients (stage II-IV) are allowed 2 additional cycles of rituximab at the end of the 6 cycles of R-CHOP.
15996605|NCT02916290|Drug|Fuzhenghuayu|
15996606|NCT02916290|Drug|UDCA|
15996607|NCT02916277|Biological|endocan|to look series Endocan level for 5 days in intubated patients
15996680|NCT02915744|Drug|Gemcitabine|
15996681|NCT02915744|Drug|Paclitaxel|
15996682|NCT02915744|Drug|Docetaxel|
15996683|NCT02915744|Drug|Nab-paclitaxel|
16038335|NCT02607657|Drug|Eplerenone 100 mg|
15996608|NCT02916264|Procedure|a scalp block|Bilateral blocks of six nerves: ie. supraorbital and supraorbital nerves (V1), zygomaticotemporal nerves (V2) , auriculotemporal nerves , greater occipital nerves, and lesser occipital nerves will be performed by a well trained anesthesiologist with 0.5% bupivacaine not exceeding 3 mg/kg
15996609|NCT02916251|Drug|ZP4207(dasiglucagon) glucagon analogue|Cross-over design with single s.c. administration in euglycemic and hypoglycemic T1D
15996610|NCT02916251|Drug|Glucagon (Native glucagon)|Cross-over design with single s.c. administration in euglycemic T1D
15996611|NCT02916238|Drug|Fluoxetine|Fluoxetine prescribed and dispensed beginning at 10 mg daily; side effects and symptoms monitored biweekly; dosage increased to 20 mg., then by 20 mg. increments according to protocol algorithm based on PHQ-9 score to a maximum dose of 60 mg.
15996612|NCT02916238|Behavioral|Enhanced Usual Care|Depression symptoms monitored at 3 month intervals; results from PHQ-9 available to ART clinic physicians.
15996613|NCT02916225|Behavioral|High Intensity Interval Training|The HIIT group will warm up for 10 minutes at 60% to 70% of peak heart rate(50% to 60% of V̇O2peak) before walking four 4-minute intervals at 85% to 95% of peak heart rate. Each interval will be separated by 3-minute active pauses, walking at 60% to 70% of peak heart rate. The training session will be terminated by a 3-minute cool-down at 60% to 70% of peak heart rate. Total exercise time will be 38 minutes for the HIIT group. Patients will perform 3 training sessions per week for 12 consecutive weeks.
15996614|NCT02916225|Behavioral|Moderate Continuous Training|The moderate continuous training (MCT) group will undergo treadmill walking continuously at 60% to 70% of peak heart rate for 47 minutes each session to make sure the training protocols will be isocaloric. Patients will perform 3 training sessions per week for 12 consecutive weeks.
15996615|NCT02916212|Other|Optimized alarm profiles|
15996616|NCT02916199|Device|cannulation of ampulla of Vater|Cannulation of ampulla of Vater is a procedure that a guide-wire is passed through ampulla using interventional devices
15996617|NCT02916186|Biological|Acellular Dermal Matrix|Puros Dermis is a collagenous membrane derived from solvent preserved,human dermis, works as biological scaffold for the new formation of vasculated connective tissue.
15996618|NCT02916186|Procedure|Tunnel technique with the subepithelial connective tissue graft|Tunnel prepared with the placement of subepithelial connective tissue graft harvested from the palate
15996619|NCT02916173|Drug|Recombinant Human Chorionic Gonadotrophin|250 unit intramuscular
15996620|NCT02916173|Drug|human chorionic gonadotrophin + gonadotrophin releasing hormone agonist|250 unit intramuscular + 1 mg subcutaneous
15996621|NCT02916160|Drug|SACUBITRIL - VALSARTAN (formerly LCZ696, ENTRESTO®)|SACUBITRIL - VALSARTAN (formerly LCZ696, ENTRESTO®) is a new treatment of HF recently indicated class I, level B in the recent ESC guidelines 2016 on HF. It combines inhibitory prodrug neprilysin and valsartan.
15996622|NCT02916147|Drug|Sevoflurane|
15996623|NCT02916147|Drug|Propofol|
15996624|NCT02916134|Procedure|Laparoscopic +/- Open Appendicectomy|Laparoscopic +/- open appendicectomy , with antibiotics at induction (intravenous co-amoxiclav 1.2g, or if penicillin allergic, cefuroxime 1.5g + metronidazole 500mg ), followed by 3 further intravenous doses of the same antibiotic. If a perforation is identified at the time of surgery, microbiology will be contacted regarding choice and duration of of antibiotic.
15996625|NCT02916134|Drug|Antibiotic treatment|"Intravenous co-amoxiclav 1.2g three times daily, then 625mg, orally three times daily. If penicillin allergic, intravenous cefuroxime 1.5g three times daily + metronidazole 500mg three times daily, then oral cefuroxime 500mg twice daily + oral metronidazole 400mg three times daily.
~The patient will receive inpatient intravenous antibiotics until sufficient clinical improvement is noted by the surgical team, who will be assessing the patient twice daily. After discharge the patient will receive 5 further days of oral antibiotics."
15996626|NCT02916121|Dietary Supplement|folic acid 5 mg/cap|the intervention includes folic acid 5 mg/d and vitamin B12 500 ug/d
15996627|NCT02916121|Other|Placebo|placebo
15996628|NCT02916108|Other|Reading EEG|EEG recording for 5 minutes (not an intervention)
15996629|NCT02916095|Drug|Kanitinib|Oral administration of Kanitinib tablets.
15996630|NCT02916082|Procedure|Cervical length measurement|Vaginal ultrasound to measure cervical length previous to use of prostaglandins.
15996631|NCT02916069|Device|Nearinfrared Spectroscopy (NIRS)|Patients will be monitored and interference will be done to optimize the medical condition based on such monitor
15996632|NCT02916069|Device|Transcranial Doppler (TCD)|Patients will be monitored and interference will be done to optimize the medical condition based on such monitor
15996633|NCT02916069|Device|Bispectral index (BIS)|Patients will be monitored and interference will be done to optimize the medical condition based on such monitor
15996634|NCT02916056|Drug|Azeliragon 5mg|
15996635|NCT02916043|Procedure|Cardiovascular surgery with cardiopulmonary bypass|Patients who underwent cardiovascular surgery including valve replacement or thoracic aortic surgery with cardiopulmonary bypass
15996636|NCT02916030|Dietary Supplement|Vit D|It is to examine the relationship between serum 25 (OH) D levels and Stroke either ischemic or hemorrhagic types
15996637|NCT02916004|Device|Measurement of NFR and PDR|Feasibility testing of NFR and PDR in sedated, ventilated patients. Comparison of NFR and PDR with standard routine care of pain assessment
15996638|NCT02915978|Drug|Fentanyl|Fentanyl delivered via sublingual spray
15996639|NCT02915978|Drug|Placebo|Matching placebo delivered via sublingual spray
15996640|NCT02915965|Drug|DCX|docetaxel, cisplatin and capecitabine
15996641|NCT02915965|Procedure|surgery|Ivor Lewis Esophagectomy
15996642|NCT02915952|Device|Zip Surgical Skin Closure Device|The Zip Surgical Skin Closure Device will be used for surgical wound closure in C-Section Surgery
15996643|NCT02915952|Other|Conventional Sutures|Conventional Sutures will be used for surgical wound closure in C-Section Surgery
15996684|NCT02915731|Dietary Supplement|Vitamin A supplement|200 000 IU vitamin A (once-off dose), given to participants as part of the national vitamin A supplementation program
15996685|NCT02915718|Procedure|protein A immunoadsorption|protein-A immunoadsorption for 5 days and i.v. IgG（0.5g/kg Body weight）substitution
15996686|NCT02915705|Biological|burosumab|solution for subcutaneous (SC) injection
15996687|NCT02915705|Drug|Oral Phosphate Supplement|oral tablet; oral solution; oral powder
15996688|NCT02915705|Drug|active vitamin D|tablet, oral solution
16043795|NCT02569658|Drug|Placebo|
15996644|NCT02915939|Behavioral|The Residential Care Transition Module|Residential Care Transition Module sessions focus on the experiences of the caregiver, the care recipient, and (potentially) other family members immediately following residential long-term care (RLTC) admission. The sessions are designed to establish a therapeutic rapport with the caregiver and the family; provide a safe environment to explore stressors; examine family relational dynamics as they relate to the RLTC placement decision itself as well as the roles different family members play in the life of the caregiver and relative in RLTC; identify new modes of communication to facilitate more effective interactions with other family members and care staff; and identify effective ways to advocate for improved quality of care for and quality of life of their relatives in RLTC.
15996645|NCT02915926|Behavioral|occupational performance coaching|
15996646|NCT02915926|Behavioral|standard OT|
15996647|NCT02915913|Behavioral|Experimental: High Intensity Interval|Walking on a treadmill 4min at 80-90% peak heart rate and recovery 4 min at 65% peak heart rate until expenditure of 500 kcal
15996648|NCT02915913|Behavioral|Resistance training|Completing a resistance circuit (including upper and lower muscle groups) as many times as needed according to subject weight until expenditure of 500 kcal
15996649|NCT02915913|Behavioral|Plus: High Intensity Interval + Resistance Training|Walking on a treadmill as intervention 1 until 50% the energy expenditure prescribed is reached, then completing a resistance circuit until 100% energy expenditure is reached
15996650|NCT02915913|Other|Non-exercise|This group will receive the usual clinical care according to the consensus recommendations of the national goals for cardiovascular health promotion and disease reduction of the American Heart Association and Colombian guidelines COLDEPORTES.
15996651|NCT02915900|Other|Gonadotropin removal test|Patient receives hormone dosage adjusted according to the results of the Gonadotropin removal test.
15996652|NCT02915900|Other|Routine IVF method|Patient receives hormone dosage according to the standard dosage regimen, without revealing the results of the Gonadotropin removal test to the clinician.
15996653|NCT02915887|Other|Cervical Taping|Kinesio®Tex Tape 23 was used in this study. Two strips of tape were applied. The first layer was a Y-shaped strip with 2 tails on 2 sides of the cervical vertebrae, placed over the posterior cervical extensor muscles and applied from the insertion to origin. The second strip was an I-shaped approximately 20cm long, transversally applied over the C5-C7 vertebra with a tension-on-base technique in a space correction technique.
15996654|NCT02915874|Behavioral|Acceptance and Commitment Therapy|
15996655|NCT02915861|Other|Non-invasive eschar samples + blood|EXPa (n=12) will have blood and non-invasive eschar samples collected (consent to study, declined biopsy).
15996656|NCT02915861|Other|Non-invasive eschar samples+eschar biopsy+blood|EXPb (n=12) will have blood, non-invasive eschar samples, and an eschar biopsy collected (consent to study, draining LN inaccessible).
15996657|NCT02915861|Other|Non-invasive eschar samples+eschar biopsy+lymph node fine-needle aspiration biopsy+blood|EXPc (n=12) will have blood, non-invasive eschar samples, eschar biopsy, and LN FNA collected (consent to study, draining LN accessible).
15996658|NCT02915861|Other|Blood+Skin sample|Controls (EXC, n=12) are healthy individuals, attending hospital for elective/minor surgery or treatment of minor skin injury, and normally reside in a scrub typhus endemic region. Blood and a skin sample will be collected at baseline only.
15996659|NCT02915848|Device|PC+S group|PC+S group: participants in the study will also receive a specific stimulation device (Activa PC+S, Medtronic) that is capable of recording the local field potentials (LFP). Approximately 10 participants are expected to take part in this study at UHN.
15996660|NCT02915835|Drug|Riociguat|riociguat 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg administered TID; dose titration starting with 1.0 mg (planned up-titration every 2 weeks, with possibility of dose reduction for tolerability; 0.5 mg is the lowest dose and 2.5 mg is the highest dose to be administered)
15996661|NCT02915835|Drug|Placebo|Placebo 0.5 mg, 1 mg, 1.5 mg, 2 mg and 2.5 mg administered TID;
15996662|NCT02915822|Procedure|Minimally Invasive Chevron/Akin osteotomy|Minimally invasive technique for hallux valgus correction
15996663|NCT02915822|Procedure|Open Scarf/Akin osteotomy|Open technique for Hallux Valgus correction
15996664|NCT02915809|Biological|GC3110B vaccine|0.5mL, Intramuscular
15996665|NCT02915809|Biological|GCFLU Quadrivalent Inj. vaccine|0.5mL, Intramuscular
15996666|NCT02915796|Biological|G-CSF + CD133(+) cells|Patients in the G-CSF + CD133(+) cells + PTA group, received 150 unit of recombinant human G-CSF intramuscular injection to mobilize CD 133 cells from bone marrow to peripheral blood. After 72-120 hrs, 100 ml suspension of peripheral arterial blood were collected and send to Good Products Manufacturing (GPM) certified laboratory (Shanghai Chen Chuan Biological Material Co. Ltd.) within 24 hrs of obtaining sample to isolate CD 133(+) endothelial progenitor cells (EPC) using magnetic cell separator. Subjects in this group, after vascular PTA treatment, received transarterial infusion of 50 ml suspension of isolated autologous CD 133(+) cells over 30 min via catheter opened into popliteal artery. The infusion of CD 133 cells was repeated after 24 hours.
15996667|NCT02915796|Biological|G-CSF|Subjects in this group, after vascular PTA treatment, received 150 unit of recombinant human G-CSF intramuscular injection to mobilize EPCs from bone marrow to peripheral blood. But the C133 (+) cells were not isolated from the peripheral blood to infuse transarterially as in G-CSF + CD133(+) + PTA.
15996668|NCT02915796|Procedure|percutaneous transluminal angioplasty (PTA)|Subjects in this group only underwent below the knee percutaneous transluminal angioplasty .
15996669|NCT02915796|Biological|Placebo infusion|Neither G-CSF was injected nor CD133(+) cells. Instead, subjects received placebo infusion (50 ml of 0.9% sodium chloride injection ) over 30 min.
15996670|NCT02915783|Drug|lenvatinib|4 mg and 10 mg capsules
15996671|NCT02915783|Drug|everolimus|5 mg tablets
15996672|NCT02915770|Procedure|cholangiojejunostomy|Half of participants will receive hepatectomy, cholangiojejunostomy and T-tube Drainage,while the other half will receive hepatectomy and T-tube Drainage
15996673|NCT02915770|Procedure|hepatectomy|
15996674|NCT02915770|Device|T-tube|T-tube Drainage
15996675|NCT02915757|Device|EDOR test|"The ElectroDermal Orienting Reactivity (EDOR) specifically is optimized for the detection of electrodermal hyporeactivity.
~The EDOR investigation last about 30 min. The EDOR Test Data is sent immediately after each EDOR Test for each Test Person to a Company named EMOTRA for blind analyses. The EDOR Test Report may change the basis for the assessment and a new risk assessment may be needed to be done.
~Blood sample and clinical assessment"
15996689|NCT02915692|Device|ERASE Silver Coated Foley Catheter|Foley catheter from ERASE CAUTI Kit will be administered as required.
15996690|NCT02915692|Device|Comparator Silver Coated Catheter|Foley catheter coated with silver
15996691|NCT02915679|Other|Blood sample for genetic purpose, psychiatric assessment and pain investigation|"All the participant will performed the same evaluation and blood analysis:
~A clinical assessment by psychiatrics assessing psychiatric disorder and suicidal behavior
~Thermal stimulation for pain assessment
~Computer game named Cyberball: test of social exclusion
~Self report questionnaire for the assessment of reject sensitivity, relationship style, impulsivity, childhood trauma.
~Routine blood sampling"
15996692|NCT02915666|Drug|Digoxin Combination|Digoxin 0.25 mg PO daily will be given for 8-week cycles
15996693|NCT02915666|Drug|Dabrafenib|dabrafenib 150mg PO twice daily for 8-week cycles
15996694|NCT02915666|Drug|Trametinib|trametinib 2 mg PO daily for 8-week cycles
15996695|NCT02915653|Other|Educational materials on a new diagnostic service|Educational materials on a new diagnostic service
15996696|NCT02915640|Other|Remote technology|Utilization of remote technology versus not using remote technology when triaging and managing pediatric patients in remote settings prior to pediatric specialized inter-facility transportation.
15996697|NCT02915627|Device|Application of Antishock garment|anti-shock garments are applied. Participants will then be examined for two 15 minute intervals with and without the anti-shock garments applied. During each 15 minute interval, echocardiograms will be performed.
15996698|NCT02915614|Procedure|Pulmonary rehabilitation|3-weeks of inpatient pulmonary Rehabilitation including exercise Training (daily endurance and strength Training)
15996699|NCT02915601|Drug|Sodium bicarbonate|
15996700|NCT02915601|Drug|Placebo|
15996701|NCT02915588|Other|early isometric loading after rotator cuff surgery|
15996702|NCT02915588|Other|passive motion after rotator cuff surgery|
15996703|NCT02915575|Other|Risk guided follow-up|Participant will be stratified for risk of CKD in three groups: Low (<1% risk of CKD), medium (1-10 % risk of CKD) and high (≥10 % risk of CKD). Specific follow-up will be guided by risk status
15996704|NCT02915575|Other|Usual Care|Participants will be discharged as per usual ward discharge protocols.
15996705|NCT02915562|Other|exercise|
15996706|NCT02915549|Other|Progressive Feeding without MEF|This group will receive feeding volumes of 20-24ml/kg/d of day 1 of feeding followed by the study intervention of daily volume increases in increments of 24-25ml/kg/d as tolerated until full enteral feeding is achieved.
15996707|NCT02915549|Other|Progressive Feeding with MEF|This group will receive minimal enteral feeds (MEF) with volumes of 20-24ml/kg/d for 4 days followed by daily increases in increments of 24-25ml/kg/d as tolerated until full enteral feeding is achieved.
15996708|NCT02915536|Other|Natural exposure of high iodine|Natural exposure of high iodine intake from drinking water
15996709|NCT02915523|Drug|entinostat|An orally available histone deacetylases inhibitor (HDACi).
15996710|NCT02915523|Drug|avelumab|A fully human antibody of the immunoglobulin (Ig) G1 isotype that targets and blocks Programmed death-ligand 1 (PD-L1), the ligand for Programmed cell death protein 1 (PD-1) receptor.
15996711|NCT02915523|Drug|Placebo|A pill containing no active drug ingredient.
15996712|NCT02915510|Dietary Supplement|Glycomacropeptide-based protein substitute|
15996713|NCT02915497|Behavioral|Abbreviated Early Prolonged Exposure Therapy|Since many trauma patients are discharged within 4 weeks, AEPET with the same length (45 minutes - 1 hour) and number of sessions as PET, is given in a shorter time period (daily for 3 days as opposed to weekly over 3 weeks).
15996714|NCT02915484|Device|Transcranial Direct Current Stimulation|TDCS involves sending a weak electrical current to the brain to modulate brain functions.
15996715|NCT02915471|Behavioral|Virtual Peer-to-Peer Support Mentoring|The mentorship program will encourage mentored participants to develop and engage in self-management and transition skills and support their practice of these skills. The mentors will present information to mentored participants in a monitored virtual interaction using Skype for 8 weeks (10 total Skype sessions of 45 minutes each) to encourage participation in skill building tailored to their needs. All mentors will complete a paid 1.5 day training course and will be supported throughout the duration of the study (consultations with research staff to deal with unforeseen concerns). Mentored participants will complete online outcome measures prior to randomization (T1) and upon study completion (T2).
15996716|NCT02915445|Biological|CAR-T cells recognizing EpCAM|Patients included will be infused the autologous T cells armed with CAR recognizing EpCAM. After infusion, cytokines and other medical test will be performed.
15996717|NCT02915432|Biological|3 mg/kg anti-PD-1 mAb JS001 Q2W|"This study is planned to conduct the 3 mg/kg dose group study at first. After enrollment, the subjects will be administered every 2 weeks (Q2W) with 4 weeks as a cycle, until absence of further benefits, acceptable toxicity, investigator decision, consent withdrawal or death.
~If patient experiences 1st onset of disease progression and investigator judges that patient will obtain clinical benefit from the study treatment, patient can continue the study treatment after the discussion between investigator and medical monitor from sponsor or authorized CRO and approval is obtained afterwards. If the subject develops 2nd disease progression after 1st disease progression, he/she should permanently withdraw from the study treatment."
15996718|NCT02915432|Biological|360 mg anti-PD-1 mAb JS001 Q3W|Subjects will receive corresponding regimen of standard first-line chemotherapy combined with JS001 360 mg once every 3 weeks (Q3W). JS001 360 mg Q3W can be administrated after the end of chemotherapy until absence of further benefits judged by the investigator, disease progression, occurrence of intolerable toxicity, investigator's decision, and withdrawal of informed consent by the subject, or death.
15996719|NCT02915432|Biological|240mg anti-PD-1 mAb JS001 Q3W|Subjects will receive corresponding regimen of standard first-line chemotherapy combined with JS001 240 mg once every 3 weeks (Q3W). JS001 240 mg Q3W can be administrated after the end of chemotherapy until absence of further benefits judged by the investigator, disease progression, occurrence of intolerable toxicity, investigator's decision, and withdrawal of informed consent by the subject, or death.
15996720|NCT02915419|Biological|PRP|platelet rich plasma
15996721|NCT02915419|Biological|PRF|PLATELET RICH FIBRIN
15996722|NCT02915406|Device|CliniMACs|
15996812|NCT02914678|Other|Fentanyl|Change in protocol from 2 to a total of 3 μg/kg fentanyl per transport
15996813|NCT02914665|Drug|elamipretide|20 mg elamipretide administered intravenously once daily for 7 consecutive days
15996723|NCT02915380|Biological|Evaluation of pituitary endocrine function|"The basal thyroid hormone and test to perform will be: TSH, fT4, fT3.
~When available, the following hormones will be tested:
~FSH, LH, estradiol (in women), testosterone (in men), sex hormone-binding globulin (SHBG), ACTH, cortisol, prolactin, Na, K; serum levels of GH and IGF-1; and serum and urine osmolality.
~Adrenal function will be evaluated through ACTH-stimulation testing . Adrenal or GH insufficiency will be evaluated by insulin tolerance testing (ITT)"
15996724|NCT02915380|Behavioral|Evaluation of clinical outcome|Patients' outcome will be assessed as modified Rankin Scale (mRS) at discharge from the hospital, at 3, 6 and 12 months.
15996725|NCT02915380|Behavioral|Evaluation of neuropsychological function|Neuropsychological examination will be conducted focusing on verbal comprehension (Token Test) and visual neglect. Verbal and visual short term and working memory visuospatial construction and figural memory will be performed through Rey Osterrieth Complex figure test, and psychomotor speed attention and concentration through Trail Making Test.
15996726|NCT02915367|Behavioral|SMS Reminders|Participants will receive daily reminders, with content and timing of their choosing, regarding their PrEP use. Participants will have the choice to later receive SMS reminders only when they forget to take their dose (as indicated by real-time adherence monitoring via WisePill).
15996727|NCT02915354|Drug|Etanercept|Etanercept must be discontinued. Cotherapy with disease modifying anti-rheumatic drugs or non-steroidal anti-inflammatory drugs could be continued if maintained at a stable dose for at least 4 weeks.
15996728|NCT02915328|Device|Filterwire EZ™|
15996729|NCT02915328|Device|MO.MA Ultra|
15996730|NCT02915328|Device|Stent Roadsaver®|
15996731|NCT02915328|Device|Carotid Wallstent|
15996732|NCT02915315|Dietary Supplement|salt|The protocol comprise a questionnaire survey and physical examination during a 3-day baseline observation period, a low-salt diet for 7 days (3g of salt per day) and a high-salt diet for 7 days (18g of salt per day). During the baseline period, each subject is given detailed dietary instructions to avoid table salt, cooking salt, and high-salt foods for the 17-day study duration. To ensure compliance of study participants with the intervention program, they are required to have their breakfast, lunch, and dinner at the study kitchen under supervision of the study staff during the entire study period. All foods are cooked without salt. Onsite study staff members add repackaged salt to the meals of individual subjects as indicated by the study protocol.
15996733|NCT02915302|Biological|Fluzone Quadrivalent vaccine, No Preservative|0.25-mL (Pediatric Dose), Intramuscular (2016-2017 formulation)
15996734|NCT02915302|Biological|Fluzone Quadrivalent vaccine, No Preservative|0.5-mL, Intramuscular (2016-2017 formulation)
15996735|NCT02915289|Procedure|Povidone Iodine|Vaginal preparation with 10% povidone iodine prior to non-emergent cesarean section.
15996736|NCT02915289|Procedure|Chlorhexidine gluconate|Vaginal preparation with 4% chlorhexidine gluconate prior to non-emergent cesarean section.
15996737|NCT02915276|Procedure|Blastocentisis|Removal of blastocoelic fluid from the blastocoelic cavity
15996738|NCT02915276|Procedure|Trophectoderm biopsy|Removal of trophectoderm cells from the blastocyst
15996739|NCT02915263|Drug|IGIV-C|Gamunex-C [immune globulin injection (human) 10% caprylate/chromatography purified] is a sterile solution of human immune globulin protein.
15996740|NCT02915263|Drug|0.9% Sodium Chloride|Sodium Chloride (also known as saline) is a solution of sodium chloride, or salt, and sterile water.
15996741|NCT02915250|Drug|BioChaperone® Combo|Injection of BioChaperone® Combo
15996742|NCT02915250|Drug|Humalog® Mix25|Injection of Humalog® Mix25
15996743|NCT02915250|Drug|Humalog®|Injection of Humalog®
15996744|NCT02915250|Drug|Lantus®|Injection of Lantus®
15996745|NCT02915250|Drug|Placebo|Injection of 0.9% NaCl
15996746|NCT02915237|Dietary Supplement|Concord grape juice|Daily dietary supplementation with a commercially available Concord grape juice.
15996747|NCT02915237|Dietary Supplement|Placebo Beverage|Daily dietary supplementation with a placebo beverage consisting of water, sugar, artificial flavoring and color that is formulated to look and taste like grape juice and have the same carbohydrate composition and energy load.
15996748|NCT02915224|Drug|Chlorambucil|Participants will receive chlorambucil as per summary of product characteristics in daily practice. Protocol does not specify any dosage.
15996749|NCT02915224|Drug|Obinutuzumab|Participants will receive obinutuzumab as per summary of product characteristics in daily practice. Protocol does not specify any dosage.
15996750|NCT02915211|Dietary Supplement|Keyo|Keyo is a Food for Special Medical Purposes (FSMP) and is intended for use in the KD. It has a fat to protein and carbohydrate ratio of 3 to 1. This makes it appropriate for inclusion in all versions of the KD - classical, MCT, MAD and LGI. Keyo has been designed as a nutritionally complete, ready to use, pleasant tasting and versatile medical food for use in a KD.
15996751|NCT02915198|Drug|Metformin XR|"For patients < 80 years of age at the time of a study visit, and with most recent eGFR 45 mL/min/1.73 m2, study medication dose may be increased in a stepwise fashion to a maximum of 4 tablets daily, corresponding to metformin XR 2000 mg or matching placebo.
~For patients 80 years of age or with most recent 30 eGFR < 45 mL/min/1.73 m2, the maximum dose of study medication is 2 tablets daily, corresponding to metformin XR 1000 mg or matching placebo."
15996752|NCT02915198|Drug|Placebo|"For patients < 80 years of age at the time of a study visit, and with most recent eGFR 45 mL/min/1.73 m2, study medication dose may be increased in a stepwise fashion to a maximum of 4 tablets daily, corresponding to metformin XR 2000 mg or matching placebo.
~For patients 80 years of age or with most recent 30 eGFR < 45 mL/min/1.73 m2, the maximum dose of study medication is 2 tablets daily, corresponding to metformin XR 1000 mg or matching placebo"
15996753|NCT02915185|Procedure|strength training intervention|The strength training program will last 4 weeks (3 times/week, 60 minutes). Using dead weights, the 1RM (i.e. the maximal load that an individual can lift once) will be estimated by the 10RM in order to avoid tendino-muscular injuries and fatigue. The 10RM will be determined for the muscles playing a key role in the functional performance of the upper limb, which are the wrist extensors and the elbow and shoulder flexors. In addition, the grip muscles of the affected hand will be trained with a JAMAR® dynamometer. Participants' maximal grip force will be determined and used to dose the training of the hand muscles and its progression. The training will begin and end by a 5-minute warm-up and relaxation period comprising of active movements of the trained muscles.
15996814|NCT02914665|Drug|Placebo|Placebo administered intravenously once daily for 7 consecutive days
15996754|NCT02915185|Device|tDCS|An anodal montage over the ipsilesional hemisphere will be used where the anode will be placed over the ipsilesional M1 area whereas the cathode will be placed on the contralateral supra-orbital region.For the tDCS real group, a direct current will be generated by a tDCS stimulator and gradually increased in a ramp-like fashion over the first 8 seconds until a maximum intensity of 2 mA is achieved. The tDCS will be applied for 20 minutes during each training session for a total of 12 sessions. For the group receiving sham tDCS, the protocol will be similar to the tDCS real group although the stimulation will be applied for the first 30 seconds only; a duration long enough to induce similar perceived sensation as real tDCS (tingling), to keep participants' blind to the tDCS type.
15996755|NCT02915172|Drug|Lenvatinib|"Phase 1 Dose Escalation: Starting dose of Lenvatinib 10 mg by mouth once daily of a 21 day cycle.
~Phase 2 Dose Expansion: Starting dose of Lenvatinib is maximum tolerated dose from Phase 1."
15996756|NCT02915172|Drug|Capecitabine|Phase 1 Dose Escalation and Phase 2 Dose Expansion: Capecitabine 1000 mg/m2 twice daily by mouth on Days 1 - 14 of a 21 day cycle.
15996757|NCT02915159|Biological|Abatacept|
15996758|NCT02915159|Other|Placebo|
15996759|NCT02915146|Radiation|combined ultraviolet phototherapy (NB-UVB + UVA1) vs. NB-UVB monotherapy|NB-UVB combined with UVA1
15996760|NCT02915133|Procedure|macular buckling surgery|Participants with high myopia foveoschisis are scheduled to macular buckling (MB) surgery.
15996761|NCT02915120|Procedure|Real Pulsed Radiofrequency|"Pulsed Radiofrequency uses radiofrequency current in short (20 ms), high-voltage bursts; the silent phase (480 ms) allows time for heat elimination, generally keeping the target tissue below 42° C. The Radiofrequency (RF) electrode will be inserted through the canula, and RF lesions will be generated by applying pulsed RF treatment to the inferomedial (IM), superomedial (SM), and superolateral (SL) GN branches for 8 minutes at 42°C."
15996762|NCT02915120|Procedure|Sham Pulsed Radiofrequency|Control patients will undergo the same procedure. The sensorial and motor stimulations will be applied too. The RF electrode will be then inserted through the cannula, and RF lesions will be simulated without applying pulsed RF treatment to the IM, SM and SL, GN branches for 8 minutes each GN branch and the temperature of the electrode tip was not raised.
15996763|NCT02915107|Device|BioFreedom|PCI with BioFreedom
15996764|NCT02915107|Device|Orsiro|PCI with BioFreedom
15996765|NCT02915094|Drug|Anakinra|
15996766|NCT02915081|Other|Blue light|"Illumination: High illumination lighting will be instituted with a Day*Light Classic Light (Uplift Technologies, Dartmouth, NS)
~Blue wavelength: Each subject will be fitted with blue filtered goggles (Lee Filters, Burbank, CA). These goggles ensure the transmission of a bright (1700 lux) blue (peak 442 nm) spectrum light when the subject is within 12 inches.
~Photoperiod: A 24-hour photoperiod will be used that commences at 0800 the morning prior to surgery and continues for 24 hours. To account for potential variability in the exposure of interest, each subject will complete a diary to catalogue duration and distance of light exposure. Postoperatively the same photoperiod will be instituted and continued for one 24 hour period."
15996767|NCT02915068|Behavioral|EHR-Physician Asthma Care Education Program|participants will receive EHR-PACE, an interactive 1.5 hour training module that teaches clinicians best practices for communicating with patients in the presence of computer systems in the exam room (specifically EHRs).
15996768|NCT02915055|Drug|Ibuprofen 600 mg|Ibuprofen 600 mg to be taken every 8 hours (TID) as needed (PRN
15996769|NCT02915055|Drug|standard oxycodone/acetaminophen|
15996770|NCT02915042|Drug|Dexmedetomidine|Analgesic Efficacy
15996771|NCT02915042|Drug|Placebo|Saline placebo
15996772|NCT02915029|Other|Educational and lifestyle coaching|"Educational lifestyle and patient activation is a CHR lead home visits every other week to provide education on healthy lifestyles (diet, exercise, alcohol abuse and smoking) as patient preference; Education provided on management of diabetes, hypertension and hyperlipidemia POC testing for A1C and microalbuminuria conducted at patient homes. Lifestyle and diet related Motivational messaging carried out regularly. Patient will receive group session at the clinic every quarters.
~Control arm will receive their usual care provided by IHS. The control group will receive a health evaluation at the initiation of the study and at the 6-month and 12-month."
15996773|NCT02915016|Biological|DNA-HIV-PT123 vaccine|Contains a mixture of three DNA plasmids in a 1:1:1 ratio, each at 1.33 mg: 1) clade C 96ZM651 gag, 2) clade C 96ZM651 gp140, and 3) clade C CN54 pol-nef, delivered at a total dose of 4 mg, administered by intramuscular (IM) injection to the left deltoid as a single 1 mL dose.
15996774|NCT02915016|Biological|Bivalent Subtype C gp120/MF59 vaccine|Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, each at a dose of 100 mcg, mixed with MF59 adjuvant, administered by IM injection to the right deltoid as a single 0.5 mL dose.
15996775|NCT02915016|Biological|Bivalent Subtype C gp120/AS01B vaccine|"Clade C TV1.C gp120 Env and clade C 1086.C gp120 Env, mixed with AS01B adjuvant, administered by IM injection to the right deltoid as a single 0.75 mL dose.
~Groups 2 and 5 will receive a 100 mcg dose. Groups 3, 6, and 7 will receive a 20 mcg dose."
15996776|NCT02915016|Biological|Placebo|Sodium Chloride, 0.9%, administered by IM injection at volumes to match the active products.
15996777|NCT02915003|Behavioral|E-health website|e-Health website embedded with short, culturally and locally-tailored videos informed by behavior change principles that will teach patients/families about: the importance and benefits of health insurance, ACA coverage provisions and local insurance options available to them, the specifics of the new law and how it affects them, and how to navigate local systems and resources to obtain and maintain health insurance.
15996778|NCT02914990|Drug|BPI-15086|BPI-15086 is administered once daily with a starting dose of 25 mg in a 21-day cycle. When tolerated, increasing doses of BPI-15086 will be tested in subsequent cohorts, until a maximum tolerated dose is determined.
15996779|NCT02914977|Drug|Daunorubicin|"Agent: Daunorubicin
~Dose: 6.75 mg/m2/day
~Route: IV
~Schedule: Days 1-5
~Duration: One cycle"
15996780|NCT02914964|Behavioral|Swank Diet|A Registered Dietitian Nutritionist (RDN) skilled in motivational interviewing will provide nutrition counseling to study participants to assist them in following the Swank Diet at home. An in-person counseling session will occur at study visits 2 and 3. Five telephone counseling calls will occur between visits 2 and 3. The study participant may contact the RDN with questions at any time during the intervention.
15996815|NCT02914652|Drug|Salbutamol|Ventoline(R), inhalation spray, 0,1 mg/dose, 9 doses administered as coherent single doses.
15997388|NCT02910167|Drug|Paracetamol|Paracetamol 500 mg
15996781|NCT02914964|Behavioral|Wahls Elimination Diet|A Registered Dietitian Nutritionist (RDN) skilled in motivational interviewing will provide nutrition counseling using to study participants to assist them in following the Wahls Elimination Diet at home. An in-person counseling session will occur at study visits 2 and 3. Five telephone counseling calls will occur between visits 2 and 3. The study participant may contact the RDN with questions at any time during the intervention.
15996782|NCT02914951|Behavioral|Cognitive-Behavioral Therapy|CBT is a behavioral intervention that consists of 12 60- to 90-minute-long weekly sessions. A modified, principles-based form of CBT will be used in this study to reduce complexity of activities during therapy sessions while retaining all key elements and principles of CBT.
15996783|NCT02914951|Other|Functional magnetic resonance imaging (fMRI)|Functional magnetic resonance imaging (fMRI). There will be two fMRI visits, 60 to 90 minute each, one before and the other after CBT. fMRI is a technique that uses magnetism to measure activity of the brain as participants perform simple tasks such as pressing the button in response to pictures. During this study, children will be asked to look at pictures of objects and press or not press the button in response to specific instruction. Participants will also look at pictures of faces and light-point displays depicted biological motion. fMRI is used as an outcome measure to explore if change in irritability is associated with change in brain responses to these tasks during fMRI.
15996784|NCT02914938|Drug|ME-401|60 mg
15996785|NCT02914938|Drug|Rituximab|IV infusion 375 mg/m2
15996786|NCT02914938|Drug|Zanubrutinib|80 and 160 mg bid
15996787|NCT02914925|Device|ArmeoSpring/CIT|Participating group will receive therapy with the Armeo®Spring Pediatric and CIT for 6 hours per day, 5 days per week for three weeks, totaling 90 hours
15996788|NCT02914899|Behavioral|Surveys|"Intake surveys recorded demographics, workplace profile, financial profile, health care access, cancer screening behavior, medical history, etc.
~Exit surveys asked whether drivers received shared decision making (SDM) counseling, completed LCS (low-dose computed tomography [LDCT] scan), had barriers, felt satisfied, etc."
15996789|NCT02914899|Behavioral|Navigation|CHWs facilitated SDM and LCS for drivers, providing navigation ( finding a PCP, scheduling appointments, assisting with insurance, etc.), following up on results and next steps.
15996790|NCT02914899|Behavioral|Focus groups|Gained drivers' perspectives on adapting the community health worker (CHW) model to facilitate lung cancer screening (LCS).
15996791|NCT02914899|Behavioral|In-depth interviews|"Interviews with Chinese livery bases elicited perspectives on adapting the CWH model for the drivers' occupational environment.
~Interviews with PCPs, clinic directors, etc. serving Chinese communities provided insight into adapting the CHW model within the health care context."
15996792|NCT02914886|Drug|Apidra|Half of patients with lipoatrophy will be switched randomly to insulin Apidra for 12 months. Any site other than the lipoatrophic site would be used for delivering the insulin for the purpose of this study.
15996793|NCT02914886|Drug|current insulin|Half of patients with lipoatrophy will still use their current Insulin for 6 months. After 6 months the current insulin will be switched to insulin Apidra for the next 6 months.
15996794|NCT02914873|Procedure|Active surveillance|Active monitoring of prostate cancer and curative treatment if there are signs of tumor progression.
15996795|NCT02914860|Device|Cardiac CT|"Cardiac CT - contract enhanced cardiac CT according to standard protocol
~D-SPECT SUMO study - standard SUMO protocol (suggested reduction in mIBG dose and increase in scan time to minimize overall radiation burden)
~Merge CT and D-SPECT image data to generate SUMO map."
15996796|NCT02914860|Procedure|Ablation Procedure|"CARTO-reconstruction LA, preferably during same rhythm as SUMO map (generally sinus rhythm) for use during registration of SUMO map in CARTO.
~High frequency stimulation (HFS; 20-Hz frequency, 5-ms pulse duration, and 15-mA output) to access positive vagal response (the heart rate decreasing by 50% at baseline).
~RF ablation only at points where there is an HFS positive response to SUMO DUA (in sinus rhythm if AF converts)
~Target a region of 1.0 - 1.5 cm diameter around the SUMO mIBG DUA
~Control HFS
~At operator discretion, conventional PVI by circumferential antral ablation according to standard procedures.
~Exit and entrance block confirmation
~Attempt to induce sustained atrial tachycardia; optional mapping and ablation of post-ablation atrial tachycardia."
15996797|NCT02914860|Device|D-SPECT|
15996798|NCT02914847|Behavioral|Functional Imagery Training (FIT)|Functional Imagery Training comprises of three elements: a) formulation of idiosyncratic drivers of self-harming behaviour and reasons for change; b) motivational interviewing combined with mental imagery techniques that enhance motivation to change the self-harm dysfunctional habit; c) formulation of goals for change (i.e. the goal is a desired behaviour alternative to self-harm) and practice of functional imagery to support goal achievement.
15996799|NCT02914834|Other|Acupuncture|Standardized acupuncture treatment administered for 30 minutes each session
15996800|NCT02914834|Other|Non-pain related video health education|Attention control group will watch health education videos the equivalent of 10 hours from randomization up to study completion.
15996801|NCT02914821|Behavioral|Simulated tax via 3 cent per ounce price increase|For each of the 3 experimental conditions, investigators will increase the price of sugar-sweetened beverages by 3 cents per ounce. This price increase will be reflected in the price tag and described as a surcharge. In two of the arms (Pre-K and Childhood Healthy Eating), the beneficiary of the surcharge will be named.
15996802|NCT02914808|Other|Patients will undergo a lower limb MRI and blood tests|
15996803|NCT02914795|Other|diagnostic analysis of platelet function|analysis of platelet aggregation using optical measurements as well as the commercial VerifyNow technique
15996804|NCT02914782|Other|Observational Study|
15996805|NCT02914769|Drug|Ayahuasca|patients will receive a single dose of ayahuasca.
15996806|NCT02914769|Drug|placebo|patients will receive a single dose of a passive placebo.
15996807|NCT02914743|Behavioral|Motivational Interviewing|This intervention will involve a discussion intended to explore subjects' motivations to pursue dental care and empower them to visit a dentist upon release from the hospital.
15996808|NCT02914743|Procedure|Dental cleaning|This procedure will involve the removal of plaque and supragingival and subgingival calculus from the surfaces of the teeth.
15996809|NCT02914704|Device|MRI-HIFU|Treatment of uterine fibroids with MRI-HIFU
15996810|NCT02914691|Drug|Dapagliflozine 10 mg once daily tablet treatment|
15996811|NCT02914691|Drug|Placebo identical once daily tablet treatment|
15997455|NCT02909686|Dietary Supplement|Boswellia Serrata|
15996816|NCT02914652|Drug|Norflouran (Placebo Evohaler(R) )|Placebo Evohaler(R) MDI, inhalation spray, 60 mg/dose, 9 doses administered as coherent single doses.
15996817|NCT02914639|Drug|SF0166 Topical Ophthalmic Solution|
15996818|NCT02914626|Drug|Intravitreal ranibizumab|Intravitreal ranibizumab injection
15996819|NCT02914613|Drug|SF0166 Topical Ophthalmic Solution|
15996822|NCT02914587|Device|ARTAS System|
15996823|NCT02914587|Other|Manual Implantation|
15996824|NCT02914574|Other|PowersTM strap|The powers strap aims to decrease knee varus through supporting femoral abduction and external rotation. Participants will wear the Powers strap while performing functional tasks (running, squatting, single leg step down).
15996825|NCT02914561|Drug|Filgotinib|Tablet(s) administered orally once daily
15996826|NCT02914561|Drug|Placebo to match filgotinib|Tablet(s) administered orally once daily
15996827|NCT02914548|Drug|OPA-15406|Subjects were treated with assigned 0.3% or 1% OPA-15406 ointment twice daily.
15996828|NCT02914548|Drug|Placebo|Subjects were treated with assigned 0% OPA-15406 ointment twice daily.
15996829|NCT02914535|Drug|Filgotinib|Tablet(s) administered orally once daily
15996830|NCT02914535|Drug|Placebo|Tablet(s) administered orally once daily
15996831|NCT02914522|Drug|Filgotinib|Tablet(s) administered orally once daily
15996832|NCT02914522|Drug|PTM filgotinib|Tablet(s) administered orally once daily
15996833|NCT02914509|Drug|Travoprost|
15996834|NCT02914509|Other|Placebo Vehicle|
15996835|NCT02914496|Behavioral|Acceptance and Commitment Therapy (ACT)|ACT is a specific form of Cognitive behavior therapy (CBT) which will be given as a course consisting of seven sessions where each session is two hours long.
15996836|NCT02914483|Behavioral|Enhanced Usual Care|"Participants randomized into the EUC group will complete 8 weekly individual sessions by phone. Each weekly session consists of: brief check-in and review of AHA brochure- Women, Heart Disease and Stroke."
15996837|NCT02914483|Behavioral|Stress Management|Participants randomized into the stress management group will complete 8 weekly group sessions by phone. The intervention is a telephone adaptation of mindfulness-based cognitive therapy (MBCT) and focuses on building cognitive-behavioral and mindfulness skills to help manage and cope with stress. Each hour-long weekly session consists of: check-in, instruction, skill building, discussion, and home-based practice assignment.
15996838|NCT02914483|Diagnostic Test|Actigraph|The Actigraph (wGT3X-BT) will monitor sleep activity and will be worn by participants for 7 days, pre- and post stress based intervention.
15996840|NCT02914457|Procedure|Electrophysiological Study|Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots during electrophysiological study procedure.
15996841|NCT02914431|Device|3D Printing Personalized Titanium Plate|The cutting guides were placed onto the planned position. The cutting guides also worked as the drilling guide. Several screw holes were drilled using the predetermined screw holes on the guides. The osteotomy / ostectomy then start. Next, the 3D printing personalized maxillary fixation plates were adapted to reposition the Le Fort I segment to the planned position. The screw holes on the bones prepared by the cutting guides were used as the bony reference. The personalized plate was first firmly installed on the maxilla above the osteotomy line by aligning the corresponding screw holes on the plate to the bone. Afterwards, the position of the osteotomized Le Fort I segment was adjusted till all the remaining corresponding screw holes on bone and plate were aligned.
15996842|NCT02914418|Device|Transcranial Magnetic Stimulation using iTBS Paradigm|TMS is a non-invasive, painless method of stimulating the central and peripheral nervous system. ITBS is a form of TMS which is delivered for ~200sec and can promote changes in neural activity.
15996843|NCT02914405|Drug|Nivolumab|Nivolumab is a soluble protein consisting of 4 polypeptide chains, which include 2 identical heavy chains consisting of 440 amino acids and 2 identical light chains. Molecular weight is 146,221 daltons.
15996844|NCT02914405|Drug|Ch14.18/CHO|APN311 (ch14.18/CHO) is manufactured in a Good Manufacturing Practice (GMP) compliant facility of Polymun Scientific, Austria according to a state of the art aseptic manufacturing process based on a characterized and stable Chinese Hamster Ovary (CHO) cell line. After propagation of the working cell bank (WCB) in small volume vessels/bioreactors, manufacture is carried out in a 2500 L stirred tank reactor utilizing components which are free of material of animal or human origin.
15996845|NCT02914379|Drug|[¹⁴C]-LY3337641|Administered orally
15996846|NCT02914366|Drug|Ambroxol|
15996847|NCT02914366|Other|Placebo|
15996848|NCT02914353|Drug|EP=7041|Factor X!a Inhibitor
15996849|NCT02914353|Drug|Placebo|Normal Saline
15996850|NCT02914340|Device|Spiration Valve System|
15996851|NCT02914327|Drug|SNX-5422 plus ibrutinib|SNX-5422 capsule(s) dosed every other day for 21 days out of a 28-day treatment cycle to a total dose of 56 mg/m2 SNX-5422. Subjects will self-administer daily oral ibrutinib in the afternoon at least 8 hours apart from SNX-5422 for 28 days of each cycle.
15996852|NCT02914314|Drug|perampanel|oral suspension.
15996853|NCT02914301|Device|Babyscripts Prenatal App|The use of a mobile digital app to facilitate certain aspects of standard prenatal care.
15996854|NCT02914301|Device|Placebo|No Mobile App, Usual care
15996855|NCT02914288|Other|High resolution magnetic resonance imaging for intracranial vessel walls|High resolution magnetic resonance imaging for intracranial vessel walls at initial (optional), 1 month, 3 month, 6 month (optional), and 12 month
15996856|NCT02914275|Biological|Seqirus Quadrivalent Inactivated Influenza Vaccine|The Seqirus study vaccine is a sterile, thimerosal-free suspension containing 60 mcg total hemagglutinin antigen per 0.5 mL (15 mcg each of the four recommended influenza strains for the Northern Hemisphere 2016/2017 influenza season). Subjects will receive one or two doses according to the recommendations of the Advisory Committee on Immunization Practices for the United States 2016-17 Influenza Season. Preferred sites for intramuscular injection are the anterolateral aspect of the thigh in infants 6 months through 11 months of age, the anterolateral aspect of the thigh (or the deltoid muscle of the arm if muscle mass is adequate) in children 12 months through 35 months of age.
15997456|NCT02909686|Dietary Supplement|Curcumin|
15996857|NCT02914275|Biological|Comparator Quadrivalent Inactivated Influenza Vaccine|The comparator Quadrivalent Inactivated Influenza vaccine is a US-licensed product containing four recommended influenza strains for the Northern Hemisphere 2016/2017 influenza season. Subjects will receive one or two doses according to the recommendations of the Advisory Committee on Immunization Practices for the United States 2016-17 Influenza Season. Preferred sites for intramuscular injection of the non-dominant arm in children 36 months through 59 months of age.
15996858|NCT02914262|Drug|AKB-4924|Comparison of different dosages of AKB-4924
15996859|NCT02914262|Other|Placebo|Placebo comparator
15996860|NCT02914249|Other|Orange juice (500 mL/d)|Nutritionists prescribed a low-calorie diet that was estimated from total energy expenditure (TEE) for each individual minus 500 kcal per day (30% TEE). Both groups had the same diet plan based on individual weight. The dietary plan was composed of six meals/day: breakfast (fat-free milk and coffee; whole-grain bread with margarine, and an apple); snack 1 (250 mL OJ / banana and free-fat yogurt); lunch (brown rice, beans, grilled lean meat, salad, cooked vegetables); snack 2 (250 mL OJ / free-fat yogurt with oatmeal); dinner (brown rice, beans, grilled lean meat, cooked vegetables and salad); and snack 3 (salty crackers or oat cookies, tea without sugar). Body composition measurements were collected (monthly); blood samples and dietary questionnaires (every two weeks).
15996861|NCT02914236|Device|Vivaer Stylus|Delivery of low-power, temperature-controlled, radiofrequency energy to the tissues of the internal nasal valve area
15996862|NCT02914223|Drug|Cenerimod|Oral formulation of cenerimod (2mg) containing 100 μCi (3.7 MBq) of 14C-radiolabeled cenerimod
15996863|NCT02914210|Device|Virtual physical therapy rehabilitation program|Virtual Exercise Rehabilitation Assistant (VERA), a virtual physical therapy delivery system installed in patient's home
15996864|NCT02914210|Other|No intervention|Traditional physical therapy delivered in clinic or via home-health visits
15996865|NCT02914197|Other|Full information|Patients will be randomized to receive full information or standard information at the study start. The second wave will follow the same randomization process 6 months following the study start.
15996866|NCT02914184|Biological|HRV PCV-free liquid vaccine|Subjects will receive two doses of PCV-free HRV vaccine at 6 and 12 weeks of age. The vaccine will be administered orally
15996867|NCT02914184|Biological|Rotarix|Subjects will receive two doses of currently licensed lyophilised HRV vaccine at 6 and 12 weeks of age. The vaccine will be administered orally
15996868|NCT02914171|Biological|Autologous Bone Marrow-derived Mononuclear Cells|
15996869|NCT02914171|Device|Insertable cardiac monitor|Following surgical Ebstein repair a Medtronic Reveal LINQ Insertable Cardiac Monitor (ICM) will be placed subcutaneously in the anterior chest to continuously monitor the subject's heart rhythm and to record cardiac information through automatic detection of arrhythmias.
15996870|NCT02914158|Drug|Goserelin|
15996871|NCT02914158|Drug|Tamoxifen|
15996872|NCT02914158|Drug|Aromatase Inhibitors|
15996873|NCT02914145|Drug|Dihydroartemisinin-piperaquine|Mass drug administration
15996874|NCT02914132|Device|Seraph 100 Filter|Treatment of renal replacement therapy patients with bacteremia.
15996875|NCT02914119|Drug|Rocuronium|
15996876|NCT02914119|Drug|Succinylcholine|
15996877|NCT02914119|Drug|Cisatracurium|
15996878|NCT02914119|Drug|Mivacurium|
15996879|NCT02914119|Device|Objective neuromuscular monitoring (acceleromyography)|
15996880|NCT02914119|Drug|Sugammadex|
15996881|NCT02914119|Drug|Neostigmine|
15996882|NCT02914106|Other|Observational Study|Patients were diagnosed for AIS by a certified neurologist at the Emergency Room of the Central Military Hospital. Neurological, cognitive and functional status were determined by NIHSS score, Photo test, Pfeiffer mental status score and by modified Rankin score respectively. A sample of venous blood was withdrawn in the early morning (07 to 09 AM) after assessment of neurological and cognitive status.
15996883|NCT02914093|Other|IMT|Inspiratory muscle training for 6 weeks 2x30 breaths daily as a home based program
15996884|NCT02914067|Other|Neurocognitive testing|
15996885|NCT02914067|Device|rsfcMRI|The imaging protocols will be a combined version of a standard of care (SOC) protocol with a research portion. The SOC portion of the pre-surgical scans includes a 3D T2-weighted (T2w) scans and 3D pre- and post-contrast T1-weighted (T1w) images, both at high resolution (1.0 mm3) for use in the intraoperative navigation system. This scan also includes a DTI portion for definition of fiber bundles of interest. The SOC portion of the post-surgical scans includes transverse FLAIR and post-contrast T1w images in all 3 planes. The research portion of the scan will be identical at all 3 time points and include 15 min of rsfcMRI during which the non-sedated subjects will be asked to stay still and awake while looking at a fixation cross
15996886|NCT02914054|Drug|High dose Dexamethasone pulses|In HD-DXM arm, DXM was administered intravenously at 40 mg in 500cc normal saline (0.9% saline) during 1 hour for consecutive 4 days and then stopped. This cycle was repeated in 14 days interval to receive 3 cycles of treatment.
15996887|NCT02914054|Drug|Prednisone|Patients in PDN arm received PDN orally at 1.0 mg/kg body weight daily for 4 consecutive weeks. After achieving responses the medication tapered gradually to less than 15mg daily or terminated over 4-6 weeks aimed at maintaining platelet count over 30 ×109/L.
15996888|NCT02914028|Procedure|transversus abdominis plane block|A peripheric block needle is inserted entering the facia between musculus rectus abdominis and musculus transversus abdominis with ultrasonography and local anesthetics are injected in the facia.
15996889|NCT02914028|Drug|Tramadol and paracetamol|Tramadol 100 mg and paracetamol 1000 mg are applied to the patients at the end of the surgery
15996890|NCT02914015|Procedure|Continous QLB (quadratus lumborum block)|Inject local anesthetics in between quadratus lumborum and psoas major muscle with catheter insertion and continuous local infusion
15996891|NCT02914015|Device|Philip CX50 Ultrasound Scanner|The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scan
15996892|NCT02914015|Drug|Ropivacaine|"0.6ml/kg 0.5% ropivacaine with 1:200,000 adrenaline given immediately after the correct position of the tip of the needle has been verified.
~followed with 0.2% ropivacaine infusion at a rate of 0.125ml/kg/h given through the catheter inserted in between the quadratus lumborum muscle and psoas major muscle."
15996893|NCT02914015|Drug|Morphine given as IPCA|Bolus: 1-2mg, lock time: 10min, 1h limitation: 5-10mg. without background infusion.
15997457|NCT02909686|Dietary Supplement|Epimedium|
15997458|NCT02909686|Dietary Supplement|Fisetin|
15996894|NCT02914002|Behavioral|Psychoeducational intervention|A mobile kitchen visits the 16 selected communities every 2 weeks for a period of 1 year. A 30 minute cooking lesson is given by a trained instructor, the recipes have been designed to be quick and easy to make, use local and inexpensive ingredients, contain mostly vegetables and have a good taste. During the lesson, healthy habit and cooking tips are mentioned as well as the importance of cooking at home and having family meals . A printed version of the recipe is given to every participant. Every session participants are encouraged to prepare the recipe. At the end of the lesson all the participants get to taste the meal and express their opinion.
15996895|NCT02913989|Other|Smoking habits characterization|
15996896|NCT02913976|Device|Kinesio Taping|Four Kinesio Taping strips will be placed with tension on skin forming an asterisk. The point of intersection of the four strips will be just above the myofascial trigger point. The subject will remain three days with the strips on his skin
15996897|NCT02913976|Device|Sham Kinesio Taping|Four Kinesio Taping strips will be placed without tension on skin forming an asterisk. The point of intersection of the four strips will be just above the myofascial trigger point. The subject will remain three days with the strips on his skin
15996898|NCT02913963|Device|Kinesio Taping|Four Kinesio Taping strips will be placed with tension on skin forming an asterisk. The point of intersection of the four strips will be just above the myofascial trigger point. The subject will remain three days with the strips on his skin
15996899|NCT02913963|Device|Sham Kinesio Taping|Four Kinesio Taping strips will be placed without tension on skin forming an asterisk. The point of intersection of the four strips will be just above the myofascial trigger point. The subject will remain three days with the strips on his skin
15996900|NCT02913950|Other|validation of pediatric stool scale|validation of pediatric stool scale
15996901|NCT02913937|Device|Passive ultrasonic irrigation|Endodontic irrigation followed by passive ultrasonic agitation.
15996902|NCT02913937|Device|Endodontic needle|Endodontic irrigation
15996903|NCT02913924|Drug|Clonazepam|fixed-flexible daily dose to a maximum of 2 mg (1 mg twice per day) for the first 8 weeks of the trial
15996904|NCT02913924|Drug|Placebo|
15996905|NCT02913911|Other|feedback|Sit to stand training with external feedback
15996906|NCT02913898|Behavioral|IBLT|Information bias learning task-- a computer based task in which positive information is more useful when learning how best to complete it
15996907|NCT02913898|Behavioral|IBLT control|A control version of the IBLT task-- a computer based task in which both positive and negative information is useful when learning how to complete it
15996908|NCT02913885|Drug|Curodont Repair|composed of biomimetic regeneration scaffold self-assembling peptides (P11-4) used for remineralization
15996909|NCT02913885|Drug|fluoride varnish|fluoride inhibit the progression of white spot lesion
15996910|NCT02913859|Radiation|Radiotherapy to the pelvis|Radiotherapy to the pelvis and prostate
15996911|NCT02913859|Drug|Hormonal therapy (LHRH agonist and/or antiandrogens)|life-long hormonal therapy (LHRH agonist and/or antiandrogens)
15996912|NCT02913846|Other|Nutritional evaluation|A first nutritional evaluation will be performed within 48h of patient admission. Weight and BMI will be measured once a week.
15996913|NCT02913846|Other|Muscular assessment|An assessment of muscular force will be performed once a week.
15996914|NCT02913846|Other|Pre-albumine dosage|Dosage performed once a month.
15996915|NCT02913833|Other|Pain evaluation|Pain will be assessed four times per day on a visual analogic scale.
15996916|NCT02913820|Other|snowfall > 5cm/day|the number of myocardial infarctions of every day analysed in this study will be correlated with the respective values of snowfall
15996917|NCT02913807|Procedure|Customized Jigs and Plates|The titanium locking reconstruction plates will be prefabricated based on the preoperative CT scans. Prior to procedure, customized planning for osteotomies will generate the prefabricated jigs.
15996918|NCT02913807|Procedure|Hand Contoured Osteotomies and Reconstruction Bars|This will be the traditional method of hand-conjuring the bar and bony sites.
15996919|NCT02913781|Procedure|polar body removal using zona drilling by laser then suction by injecting pipette|zona drilling with laser followed by polar body removal then ICSI procedure
15996920|NCT02913781|Procedure|Classic ICSI|Classic ICSI case was done be injecting sperm inside Oocyte while polar body is already existed at 6 or 12 O'clock position.
15996921|NCT02913768|Drug|Ondansetron|
15996922|NCT02913768|Drug|Normal saline|
15996923|NCT02913755|Behavioral|Preparatory video|5 minute Preparatory video to increase motivation, awareness and engagement in ABI rehabilitation
15996924|NCT02913742|Procedure|monitoring by depth electrode|During laser interstitial thermal ablation (LITT) for mesial temporal lobe epilepsy, the study patients will receive invasive neurophysiologic intraoperative monitoring. In addition to the typical placement of LITT stereotactic laser ablation probe via occipital burr hole, the study patients will receive an 8-contact depth recording electrode placed through an adjacent burr hole. The recording electrode will be placed into the parahippocampal gyrus in parallel to the LITT device. The patient will be monitored for epileptic discharges for 10 minutes before and 10 minutes after the ablation process to record the change in discharges during the surgery. The monitoring will not be used to guide surgery. The probe will be removed with the LITT device at the end of the procedure.
15996925|NCT02913729|Radiation|partial breast irradiation|irradiation
15996926|NCT02913716|Drug|defactinib|Single oral dose of 400 mg [14C]-defactinib
15996927|NCT02913703|Drug|Ghrelin|Boluses of Ghrelin will be given over a 1 minute period at 3 ug/kg. Ensure (2 cans) will also be given.
15996928|NCT02913703|Other|Saline|Boluses of saline will be given over a 1 minute period. Ensure (2 cans) will also be given.
15996929|NCT02913690|Dietary Supplement|Placebo|2 x 150mg capsules daily
15996930|NCT02913690|Dietary Supplement|TRF|2 x 150mg capsules daily
15996931|NCT02913677|Dietary Supplement|nutrition|Feeding was started in the first 48 hours. Fed with 10-15 ml/kg/d MEN for 5 days and than feed volumes were advanced by 20-25 ml/kg/d until 150ml/kg/d feed volume was achieved.
15996932|NCT02913664|Drug|Angiotensin II receptor blocker (ARB, losartan) and calcium channel blocker (CCB, amlodipine)|"Angiotensin II receptor blocker (ARB, losartan) and calcium channel blocker (CCB, amlodipine) will be used to reduce SBP<130 mmHg; atorvastatin 80 mg daily will be administered to reduce blood lipid level. Additional antihypertensives may be used if needed.
~Intensive Reduction of Vascular Risk Factors (IRVR)"
15996933|NCT02913664|Behavioral|Aerobic Exercise Training|Participants will take part in a supervised, moderate to vigorous aerobic exercise training program for approximately 24 months. This program consists of exercising 3 times per week for about 30 minutes per session at the beginning, and will increase to 4-5 times per week, 40-50 minutes per session over a period of 4-5 months. Exercise frequency, intensity and duration will be maintained at this level during the rest of the study period.
15996934|NCT02913664|Other|Usual Care|Participants will follow their regular doctor's recommendations for blood pressure and lipid control.
15996935|NCT02913664|Behavioral|Stretching Exercise|Participants will perform home-based stretching exercise 3 times per week, gradually increased to 4-5 times per week over a period of 4-5 months, and maintained at this level during the rest of the study period. They will be encouraged to attend monthly stretching exercise classes, which will be led by study staff or exercise trainers.
15996936|NCT02913651|Device|Polysomnography|The polysomnography, for both groups, was performed accordance with standard practice
15996937|NCT02913625|Other|Ultrasound guided retroclavicular block|Ultrasound guided retroclavicular block for forearm or hand surgery
15996938|NCT02913625|Other|Ultrasound guided infraclavicular block|Ultrasound guided infraclavicular block for forearm or hand surgery
15996939|NCT02913612|Drug|0.25% Timolol Maleate Gel Forming Solution|50:50 Randomized 0.25% Timolol Maleate Gel Forming Solution
15996940|NCT02913612|Drug|0.5% Timolol Maleate Gel Forming Solution|50:50 Randomized 0.5% Timolol Maleate Gel Forming Solution
15996941|NCT02913573|Device|Ultrasound|Pectoral nerve block is a regional block administered under ultrasound guidance which blocks the nerves of the thorax and chest areas.
15996942|NCT02913573|Drug|0.25% bupivacaine|Pectoral nerve block is a regional block administered under ultrasound guidance where 15 mL of 0.25% bupivacaine is instilled between the pectoral major and pectoral minor muscles where the lateral and medial pectoralis nerves lie. In a similar manner, 20 mL of 0.25% bupivacaine will be deposited under ultrasound-guidance at the level of the third rib above the serratus anterior muscle.
15996943|NCT02913547|Device|Silk'n HST|Treatment with Silk'n HST on the periorbital area as instructed in the user's manual
15996944|NCT02913534|Radiation|whole brain radiotherapy|
15996945|NCT02913521|Drug|Diclofenac Sodium Gel 1%|
15996946|NCT02913521|Drug|Voltaren Gel|
15996947|NCT02913521|Drug|Placebo|
15996948|NCT02913508|Drug|Vedolizumab intravenous injection|Vedolizumab intravenous injection
15996949|NCT02913508|Drug|Vedolizumab subcutaneous injection|Vedolizumab subcutaneous injection
15996950|NCT02913495|Drug|Vaginal Progesterone|
15996951|NCT02913495|Drug|Intramuscular Progesterone (17 alpha hydroxprogesterone caproate)|
15996952|NCT02913482|Drug|Risdiplam|Risdiplam will be administered orally.
15996953|NCT02913469|Drug|Morphine|The patients in group A would be administrated intravenous morphine 5mg
15996954|NCT02913469|Drug|metoclopramide|the patients in group C would be administrated intravenous metoclopramide 10mg
15996955|NCT02913469|Drug|saline|the patients in group D would be administrated intravenous 0.9%normal saline 2mland 0.9%normal saline 2ml.
15996956|NCT02913443|Drug|RO7051790|RO7051790 will be given orally. Treatment will be continued until disease progression/treatment failure, unacceptable toxicity, or study discontinuation.
15996957|NCT02913430|Drug|Fulvestrant|500mg IM Q28 days
15996958|NCT02913430|Drug|Tamoxifen|20mg PO Qdaily
15996959|NCT02913430|Drug|Palbociclib|Tamoxifen or Fulvestrant plus palbociclib125mg/day PO on a 21 days on/7 days off schedule
15996960|NCT02913417|Device|SIR-Spheres® Yttrium 90|Patient treatment will consist of three parts: first, selective internal radiation with SIR-Spheres Yttrium-90 microspheres with dosage per package insert , reduced to give 35cGymax to normal liver; second, concurrent ipilimumab 1mg/kg and nivolumab 1mg/kg every 3 weeks for 4 doses (immunotherapy part 1); then maintenance nivolumab at 480 every 2 weeks (immunotherapy part 2) until progression or 3 years
15996961|NCT02913417|Drug|ipilimumab|ipilimumab 1mg/kg every 3 weeks x 4
15996962|NCT02913417|Drug|nivolumab|nivolumab 3mg/kg every 3 weeks x 4 then 480mg q 4 weeks
15996963|NCT02913404|Procedure|ACL Reconstruction|standard surgical procedure
15996964|NCT02913404|Procedure|ACL Recon. extra-articular-tenodesis|standard surgical procedure and extra-articular-tenodesis will be used for a randomized portion of participants
15996965|NCT02913391|Other|recruitment group (RG)|After extubation the patient who was randomized to the Recruitment Group will use noninvasive ventilation (NIV) with alveolar recruitment maneuver with PEEP 15 cm H2O and afterwards 20 cm H2O remaining 2 minutes in each, then being maintained in NIV for 30 minutes with pressure support for a tidal volume of 6 ml/Kg, PEEP 8 cm H2O, Fraction of inspired oxygen for a peripheral arterial Saturation of Oxygen ≥ 95%.
15996966|NCT02913391|Other|control group (CG)|After extubation the patient who was randomized to the Control Group will use noninvasive ventilation (NIV) for 30 minutes with pressure support for a tidal volume of 6ml/Kg, PEEP 8 cm H2O, Fraction of inspired oxygen for a peripheral arterial Saturation of Oxygen ≥ 95%.
15996967|NCT02913378|Procedure|Osteosynthesis with locking plate|Open reduction and osteosynthesis with locking plate
15996968|NCT02913378|Procedure|Sling|Conservative treatment with sling and rehabilitation
15996969|NCT02913352|Procedure|Latarjet procedure|Open anterior glenoid bone graft from coracoid process
15996970|NCT02913352|Procedure|Modified Eden-Hybinette|Open anterior glenoid bone graft from iliac bone crest, with capsular suture and screw fixation
15996971|NCT02913339|Other|mHealth Risk Assessment|Using mobile phone application to calculate CVD risk and to schedule interviews at local government clinics.
15996972|NCT02913326|Drug|Dabigatran etexilate|
15996973|NCT02913326|Drug|Warfarin|
15996974|NCT02913313|Drug|BMS-986207|Specified dose on specified days
15996975|NCT02913313|Biological|Nivolumab|Specified dose on specified days
15996976|NCT02913313|Biological|Ipilimumab|Specified dose on specified days
15996977|NCT02913300|Drug|Lignocaine 1% concentration solution|
15996978|NCT02913300|Drug|Lignocaine 2% concentration solution|
15996979|NCT02913287|Dietary Supplement|Aquamin/Aquamin MG|Marine-based nutraceutical
15996980|NCT02913287|Other|Maltodextrin Placebo|Maltodextrin Placebo
15997459|NCT02909686|Dietary Supplement|Luteolin|
15997460|NCT02909686|Dietary Supplement|Nettle|
15996981|NCT02913274|Device|Paclitaxel (Taxol) eluting angioplasty balloon|Dilatation by a high-pressure conventional angioplasty balloon untill disappearance of the stenosis obstructive area and achievement of technical success. Then dilatation by a DEB of the same size for 2 minutes.
15996982|NCT02913274|Device|high-pressure angioplasty balloon|Dilatation by a high-pressure conventional angioplasty balloon untill disappearance of the stenosis obstructive area and achievement of technical success. Then dilatation either by a shame balloon or by a DEB balloon of the same size for 2 minutes.
15996983|NCT02913274|Device|low-pressure balloon|Dilatation by a high-pressure conventional angioplasty balloon untill disappearance of the stenosis obstructive area and achievement of technical success. Thenn dilatation by a shame balloon i.e conventional low pression balloon of the same size for 2 minutes.
15996984|NCT02913261|Drug|Ruxolitinib|Tablet for oral use
15996985|NCT02913261|Drug|Best Available Therapy (BAT)|Best Available Therapy
15996986|NCT02913248|Procedure|Conventional periodontal treatment|Non-surgical periodontal treatment including thorough instruction in self-performed oral hygiene
15996987|NCT02913235|Procedure|Oral hygiene discontinuation group|Discontinuation of regular oral hygiene for 10 days
15996988|NCT02913222|Other|Rehabilitation|Comparison of two rehabilitation approaches
15996989|NCT02913196|Drug|Apalutamide|"Orally available, small molecule, nonsteroidal potent and selective antagonist of the androgen receptor.
~Cohort 1 dose: 120 mg QD Cohort 2 dose: 240 mg QD Cohort 3 dose: 180 mg QD"
15996990|NCT02913196|Drug|Abiraterone acetate|"Abiraterone acetate is the prodrug of the active drug abiraterone. Once absorbed after oral administration, abiraterone acetate is rapidly converted to the active form, abiraterone.
~Dose: 1000 mg QD"
15996991|NCT02913196|Drug|Docetaxel|"Taxane cytotoxic chemotherapy with demonstrated survival benefit in those with advanced prostate cancer.
~Dose: 75 mg/m2 Q3W"
15996992|NCT02913196|Drug|Prednisone|Dose: 5 mg BID
15996993|NCT02913183|Drug|young Fresh Frozen Plasma|Blood plasma from healthy male donors aged 18-30 years old.
15996994|NCT02913183|Drug|old Fresh Frozen Plasma|Blood plasma from healthy male donors aged 40-55 years old.
15996995|NCT02913170|Dietary Supplement|Nattokinase|
15996996|NCT02913170|Dietary Supplement|Placebo|
15996997|NCT02913157|Drug|Hydroxychloroquine|Orally administered Hydroxychloroquine
15996998|NCT02913131|Drug|Pyruvate (13C)|Pyruvate injection followed by an MRI scan.
15996999|NCT02913131|Device|MRI|MRI scan following the pyruvate (13c) injection
15997000|NCT02913118|Drug|Andrographolid Sulfonate Injection (AS Injection)|
15997001|NCT02913118|Drug|Cephalosporin|
15997002|NCT02913118|Drug|Azithromycin, Minocycline or Doxycycline|
15997003|NCT02913118|Drug|Amoxicillin-clavulantic acid|
15997004|NCT02913118|Drug|Fluoroquinolones|
15997005|NCT02913118|Drug|Placebo|
15997006|NCT02913105|Drug|LMB763|Hard Gelatin Capsules
15997007|NCT02913105|Drug|Placebo|Hard Gelatin Capsule
15997008|NCT02913092|Behavioral|Electronic sensor and OW education|MDI sensor-generated alerts will be relayed via app platform on participant's phone and responded to (e.g. outreach worker contacts the patient for a missed dose) in real-time to the intervention group. Outreach worker will also assess intervention group participants' need for further asthma education and provide education over the phone
15997009|NCT02913079|Behavioral|Sit-stand desk|
15997010|NCT02913079|Behavioral|Sitting desk|
15997011|NCT02913066|Other|S-1 concurrent radiotherapy|Radiotherapy 60~66 Gray/28~33 times (50.4~60 Gray /28~33 planning target volume times, 60~66 Gray/28~33 Gross tumor volume of primary tumor), synchronous chemotherapy S-1 70 mg/m2 5 to 1 per week, to the end of radiotherapy. Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1, 70 mg/m2, 1~ 14 days, 21 days for a cycle.
15997012|NCT02913066|Other|S-1 plus Cisplatin concurrent radiotherapy|Radiotherapy 60~66 Gray/28~33 times (50.4~60 Gray /28~30 planning target volume times, Gross tumor volume of primary tumor60~66 Gray/28~33), synchronous chemotherapy S-1 70 mg/m2 1~ 14 days and 29 to 42 days, plus cisplatin 25mg/m2 1~ 4 days and 29 to 33 days. Two weeks after radiotherapy finish, two cycle adjuvant chemotherapy with S-1 70 mg/m2 1~ 14 days, plus cisplatin 25mg/m2 1~ 4 days, 21 days for a cycle.
15997013|NCT02913053|Behavioral|Aerobic exercise|Patients with mild cognitive impairment will undergo a one-year aerobic exercise program of 3 units of 45 min / week
15997014|NCT02913053|Behavioral|Non-aerobic exercise|Patients with mild cognitive impairment will undergo a one-year stretching and toning (non-aerobic) exercise program of 3 units of 45 min / week
15997015|NCT02913040|Other|High Flow Nasal Cannula|Oxygen delivery through Heated Humidified High Flow Nasal Cannula
15997016|NCT02913040|Other|Low Flow Nasal Prongs|Oxygen delivery through Low Flow Nasal Prongs
15997017|NCT02913027|Other|External Exam|"The pelvic exam will be completed in the following order: external, speculum, bimanual exam in the Standard group. In the Experimental group the pelvic exam will be done with external exam, bimanual exam, then speculum exam."
15997018|NCT02913027|Other|Bimanual Exam|
15997019|NCT02913027|Other|Speculum Exam|
15997020|NCT02913014|Other|No AAD post Ablation.|Subjects will not resume their pre-ablation anti-arrhythmic medications during the 90 following cryo ablation for Atrial Fibrillation
15997021|NCT02913001|Other|Low Glycemic Load Diet|Participants received a diet education on a low glycemic load diet.
15997022|NCT02913001|Other|Usual Eating Plan|Participants received a diet education to continue with their usual eating plan.
15997023|NCT02912988|Drug|Letrozole|Daily 150-300 IU human menopausal gonadotrophin (HMG) / Follicle stimulating hormone (FSH) from cycle day 2-4 (at least 5 days after stopping the oral contraceptive pill) and co-treatment with letrozole 2.5 mg daily from stimulation day 5 until the day before hCG administration. GnRH antagonist (cetrotide or orgalutran) 0.25 mg daily from stimulation day 5 until the day of hCG administration.
15997106|NCT02912364|Drug|Carbamazepine|Healthy adults will be titrated onto Carbamazepine (400 mg bid). After four weeks maintenance they will be tapered off and enter washout period, then crossed over to 2nd drug.
15997108|NCT02912338|Behavioral|Resistant Training|
15997109|NCT02912338|Other|Control Group|
15997461|NCT02909686|Dietary Supplement|Pycnogenol|
15997024|NCT02912975|Other|Mirror treatment|The mirror treatment: The patient sits on a chair, both knees in 90 degrees flexion, both lower limbs undressed, and places a mirror of 100 cm x 25 cm along the trans-tibial amputation stump so that the uninjured limb is reflected in the mirror while the amputation stump can not be seen by the patient. The patient then performs slow repeated movements of the foot from neutral position into maximum flexion while closely observing the reflected image of the uninjured limb - the illusion of a limb regained - in the mirror. The procedure goes on uninterrupted for five minutes in the morning and in the evening in the home of the study patient.
15997025|NCT02912975|Other|Tactile treatment|In Tactile Treatment five different sensory stimuli is applied repeatedly to the skin of the affected part of the limb, in the actual case to the amputated limb from ten cm above the knee joint and distally to include the entire amputation stump: gentle touch with a feather, a brush, a piece of paper, a stone and a wooden stick. The stimuli are applied two times daily for five 5 minutes each time, one minute per material.
15997026|NCT02912962|Behavioral|Self-Regulation Intervention adapted from the Alert Program ®|
15997027|NCT02912949|Drug|zenocutuzumab (MCLA-128)|full length IgG1 bispecific antibody targeting HER2 and HER3
15997028|NCT02912936|Dietary Supplement|Ketogenic medium chain triglyceride drink (MCT drink)|10 days supplementation with the MCT drink. Participants in dose group 1 will be assigned to 10 g per day, those in dose group 2 will be assigned 20 g per day, those in dose group 3 will be assigned 30 g per day, those in dose group 4 will be assigned 40 g per day, and those in dose group 5 will be assigned 50 g per day. The drink will be taken in the morning and evening. Participants will be enrolled 8 per group in ascending order.
15997029|NCT02912936|Dietary Supplement|Placebo|10 days supplementation with the placebo drink. Participants in dose group 1 will be assigned to 10 g per day, those in dose group 2 will be assigned 20 g per day, those in dose group 3 will be assigned 30 g per day, those in dose group 4 will be assigned 40 g per day, and those in dose group 5 will be assigned 50 g per day. The drink will be taken in the morning and evening. Participants will be enrolled 8 per group in ascending order.
15997030|NCT02912923|Other|Visual + Force Feedback|"Visual Feedback- Monitor displays two cursors that will represent the participant's hands, the cursors will fill with red ink as the user starts to compensate outside a normal error band. The amount of ink will increase proportionally to the magnitude of trunk compensation.
~Force Feedback- Cues will be provided as resistance to move the robots' handles. These cues will be applied when the user moves outside a normal error band. The magnitude of the cue will be proportional to the magnitude of trunk compensation."
15997031|NCT02912923|Other|Visual + Force + Game Scores Feedback|"Visual Feedback- Monitor displays two cursors that will represent the participant's hands, the cursors will fill with red ink as the user starts to compensate outside a normal error band. The amount of ink will increase proportionally to the magnitude of trunk compensation.
~Force Feedback- Cues will be provided as resistance to move the robots' handles. These cues will be applied when the user moves outside a normal error band. The magnitude of the cue will be proportional to the magnitude of trunk compensation.
~Game Scores- Numerical score displayed next to the cursors. The participant will be rewarded with more points when less compensation is exhibited, or with less points when an increased level of compensation is measured."
15997032|NCT02912910|Other|Nifedipine|patients will be assigned to antihypertensive medications by their physicians in the course of their routine care
15997033|NCT02912910|Other|Labetalol|patients will be assigned to antihypertensive medications by their physicians in the course of their routine care
15997034|NCT02912897|Biological|Cellular therapy with EBV specific autologous CTL infusion|CTL infusions at D0, M3 and M6
15997035|NCT02912884|Drug|No cytoreductive vs cytoreductive drugs|No cytoreductive treatment vs cytoreductive drugs (hydroxycarbamide, alpha-interferon, ruxolitinib).
15997036|NCT02912871|Other|MRIgHIFU unilateral subthalamotomy|High Intensity focused ultrasound unilateral subthalamotomy: Unilateral thermolesion in the Subthalamic nucleus performed by High Intensity Focused ultrasound
15997037|NCT02912858|Device|geko plus R-2|"The gekoTM plus R-2 devices (acting on the common peroneal nerve) and IPC devices will be activated for 10mins prior to measuring blood flow.
~The sequence of application of IPC and gekoTM plus R-2 devices will be randomly selected with 10 minutes recovery between active therapies."
15997038|NCT02912845|Drug|KamRAB - HRIG|wound infiltration or IM injection
15997039|NCT02912832|Device|TBDx|The TBDx is an automated platform is based on an Olympus BX41 microscope with a 40 x objective lens, fitted with an Olympus XC 10 colour camera and a movable slide stage, with an attached computer that receives high-quality digital images acquired from the camera. The computer then operates detection algorithms that segment, evaluate, and classify objects of interest in these images which can be stored for subsequent review. The platform is able to integrate an optional 200-slide automated slide loader for high volume settings. The application can capture 100, 300 or more digital fields-of-view and can provide results for positive or negative smears in 5 minutes or less.
15997040|NCT02912819|Other|Open-lung approach|Increase and decrease in airway pressure to open the lung and keep them opened.
15997041|NCT02912806|Procedure|Total Knee Replacement|Primary total knee arthroplasty for knee osteoarthritis
15997042|NCT02912793|Drug|Hydroxypropyl-beta-cyclodextrin|Used in the treatment of Niemann-Pick C1
15997043|NCT02912767|Behavioral|questionnaire|A questionnaire that has been validated by investigators at the Mayo Clinic. The questionnaire has 13 items to assess the rate of patient-reported lymphedema. The questionnaire will be mailed and then followed up with a second mailing after month 1 and a phone call after month 2. Within 3 months of sending the questionnaire a patient will be either considered as a responder vs non-responder. The date of surgery and the date of when the questionnaire is filled out will be captured.
15997044|NCT02912754|Drug|ruxolitinib|ruxolitinib will be added to ibrutinib or 3 out of 5 weeks per cycle
15997045|NCT02912754|Drug|ibrutinib|patients will be taking ibrutinib for at least 6 months and will continue to take it at the same dose and schedule while taking ruxolitinib
15997046|NCT02912741|Drug|Vanish xt Extended Contact Varnish|resin modified glass- ionomer cement varnish applied as a thin layer coating and cured
15997047|NCT02912741|Drug|resin infiltration|low viscous light cure resin applied in layers and cured
15997048|NCT02912728|Behavioral|CGM + Family Behavioral Intervention|use of CGM combined with a CGM focused family behavioral intervention and to assess CGM adherence
15997049|NCT02912728|Device|Standard CGM|use of CGM alone to assess CGM adherence
15997050|NCT02912715|Device|Paclitaxel releasing angioplasty balloon|Paclitaxel releasing angioplasty balloon catheter is advanced through an introducer sheath and tracked over the wire until reaching the target lesion. The balloon can be precisely positioned by means of the radiopaque markers crimped on the inner shaft of the catheter. The catheter is dilated up to its intended diameter by inflating the balloon with a solution containing contrast media, causing a compression of the arterial plaque against the inner lining of the arterial wall and improving blood flow. After balloon inflation, the drug-carrier adheres to the arterial wall and facilitates the drug release to surrounding tissue. As there is no need for sustained release of Paclitaxel after the inflation, the drug carrier dissolves rapidly.
15997051|NCT02912702|Drug|Pegaspargase|2000U/m2 day5
15997052|NCT02912702|Drug|doxorubicin hydrochloride liposome injection|25 mg/m2 day 1
15997053|NCT02912702|Drug|etoposide|100 mg/m2 was administered once on the first day of every week
15997054|NCT02912702|Drug|methylprednisolone|15 mg/kg days 1 to 3, 0.75 mg/kg days 4 to 7
15997055|NCT02912702|Drug|Etoposide|150 mg/m2 twice weekly for 2 weeks and then weekly
15997056|NCT02912702|Drug|dexamethasone|initially 10 mg/m2 for 2 weeks followed by 5 mg/m2 for 2 weeks, 2.5 mg/m2 for 2 weeks, 1.25 mg/m2 for one week, and one week of tapering
15997057|NCT02912689|Device|Neurally Adjusted Ventilator Assist|NAVA during Non-invasive ventilation
15997058|NCT02912689|Device|Pressure support ventilation|PS during Non-invasive ventilation
15997059|NCT02912676|Drug|Thioguanine (oral)|Addition of incremental doses of oral Thioguanine to oral daily 6-mercaptopurine and oral weekly methotrexate maintenance therapy of Acute Lymphoblastic Leukemia and Lymphoblastic Lymphoma. Oral 6-thioguanine is added at a starting dose of 2.5 mg/m.sq. with dose increments of 2.5 mg/m.sq. at two weeks intervals until a maximum dose of 12.5 mg/m.sq. of 6-thioguanine is given or dose-limiting toxicity occurs.
15997060|NCT02912663|Drug|Verapamil and Magnesium Sulfate|Single dose strategy will be used
15997061|NCT02912663|Other|Placebo|Single matching dosing strategy will be used
15997062|NCT02912650|Drug|Ibuprofen 250 mg / Acetaminophen 500 mg|2 caplets of Ibuprofen 250 mg / Acetaminophen 500 mg
15997063|NCT02912650|Drug|Ibuprofen 250 mg|2 caplets of Ibuprofen 125 mg
15997064|NCT02912650|Drug|Acetaminophen 650 mg|2 tablets of Acetaminophen 325 mg
15997065|NCT02912650|Drug|Placebo|2 caplets of Placebo
15997066|NCT02912637|Other|Hyperpolarized Xenon MRI|MRI & MRS of lung using inhaled hyperpolarized Xenon as a contrast agent
15997067|NCT02912611|Procedure|Education and Protocol based management|
15997068|NCT02912598|Device|Mallinckrodt™ Endobronchial Tube|
15997069|NCT02912598|Device|Fuji Uniblocker™|
15997070|NCT02912598|Device|ETView VivaSight™-SL+EB|
15997071|NCT02912598|Device|COOK© Arndt Endobronchial Blocker|
15997072|NCT02912585|Biological|Oropharyngeal administration of own mother's colostrum|
15997073|NCT02912585|Other|Oropharyngeal administration of sterile water (placebo)|
15997074|NCT02912585|Biological|Oropharyngeal administration of donor human milk|
15997075|NCT02912572|Drug|Avelumab|Avelumab will be administered intravenously twice per cycle Each Cycle lasts 28 days Premedication Antihistamine and Paracetamol will be administered prior to treatment
15997076|NCT02912572|Drug|Talazoparib|Talazoparib will be taken one time per day by mouth Each Cycle lasts 28 days
15997077|NCT02912572|Drug|Axitinib|Axitinib will be taken twice per day by mouth Each Cycle lasts 28 days
15997084|NCT02912546|Procedure|MRI|A 1.5 Tesla MRI device with a large magnet bore (70 cm) allowing positions change will be used. Two measures will be performed, one in supine position and the other in head down position (-20°). A 3D FSE ASL sequence will be acquired and CBF maps reconstructed. Volume of interest (VOI) will be placed on cortical grey matter (frontal and posterior gyrus), on subcortical deep grey matter (caudate nuclei, thalami) and subcortical white matter (semi oval centers
15997085|NCT02912533|Drug|JR-131|
15997086|NCT02912520|Drug|Anti-Bacterial Agents|administration of any antibiotic substance(s) over the course of 2 weeks
15997087|NCT02912507|Device|Cutera enlighten laser|high-powered, Q-switched 670nm Picosecond laser system indicated for tattoo removal
15997088|NCT02912507|Device|CynoSure PicoSure 755nm laser|high-powered, Q-switched Alexandrite system that delivers laser energy in the 755 nm wavelength and has received FDA clearance (K133364) for tattoo and benign pigmented lesion removal.
15997089|NCT02912494|Drug|JR-131|
15997090|NCT02912494|Drug|Darbepoetin alfa|
15997091|NCT02912481|Procedure|posterior tibial artery|
15997092|NCT02912481|Procedure|radial artery|
15997093|NCT02912481|Procedure|dorsalis pedis artery|
15997094|NCT02912468|Drug|Dupilumab SAR231893 (REGN668)|"Pharmaceutical form: Solution
~Route of administration: Subcutaneous"
15997095|NCT02912468|Drug|Placebo|"Pharmaceutical form: Solution
~Route of administration: Subcutaneous"
15997096|NCT02912468|Drug|Mometasone furoate 50 micrograms|"Pharmaceutical form: Suspension (Nasal spray)
~Route of administration: Intranasal"
15997097|NCT02912455|Drug|canagliflozin|encapsulated (gelatin capsule).
15997098|NCT02912455|Drug|Placebo (for canagliflozin)|encapsulated (gelatin capsule). The placebo capsule filler is called micro-crystalline cellulose.
15997099|NCT02912429|Device|Patellofemoral Arthroplasty|
15997100|NCT02912416|Dietary Supplement|Probiotics|
15997101|NCT02912416|Dietary Supplement|Placebo|
15997102|NCT02912390|Procedure|Cerclage|Macdonald cerclage placed in standard fashion
15997103|NCT02912390|Other|Expectant management|placed on activity restrictions: no heavy lifting, frequent reclining, and pelvic rest.
15997104|NCT02912377|Biological|Neulasta, B12019|GCSF, Growth Colony Stimulating Factor
15997105|NCT02912364|Drug|Eslicarbazepine|Healthy adults will be titrated onto Eslicarbazepine Acetate (800mg daily) . After four weeks maintenance they will be tapered off and enter washout period, then crossed over to 2nd drug.
16051158|NCT02517229|Other|Parabolic flight|
15997110|NCT02912325|Dietary Supplement|Daily administration: 2 tablets FaseMETS a day|Treatment with FaseMETS for 6 consecutive months in lowering serum lipids and glucose in subjects with Metabolic Syndrome
15997111|NCT02912312|Radiation|Hypofractionated Radiation Therapy|Undergo hypofractionated RNI
15997112|NCT02912312|Other|Laboratory Biomarker Analysis|Correlative studies
15997113|NCT02912312|Other|Quality-of-Life Assessment|Ancillary studies
15997114|NCT02912312|Other|Questionnaire Administration|Ancillary studies
15997115|NCT02912312|Radiation|Radiation Therapy|Undergo standard RNI
15997116|NCT02912299|Procedure|Skin biopsies|2 3mm skin biopsies will be taken
15997117|NCT02912299|Other|Blood and urine analysis|Measurement of sodium, potassium and kidneyfunction in blood and urine.
15997118|NCT02912299|Other|Blood collection for RNA-investigation|A blood sample that, in case of relevant differences between groups, could be used for RNA-profiling.
15997119|NCT02912286|Device|conventional needle irrigation|conventional side-vented syringe used to deliver irrigant in root canal treatment
15997120|NCT02912286|Device|passive ultrasonic irrigation|ultrasonic tip (IrriSafe) activate the irrigant after mechanical preparation in root canal treatment
15997121|NCT02912286|Device|sonic irrigation|vibringe system is a sonic device that deliver and agitate the irrigant
15997122|NCT02912273|Other|Baseline Participant Assessment|"Section 1 contains demographic questions
~Section 2 contains daily activity questions with multiple choice answers, multiple physical function questions, and if the participants has fallen and how many falls have occurred in the last 6 months
~Section 3 has the participant list all medication
~Section 4 contains several questions about participant health (lists of illnesses and indicate if illness interferes with their activities)
~Section 5 contains several questions about participant fall concerns with answers ranging from 1=Not at all to 4=Very
~Section 6 contains multiple questions asking about emotional distress/depression, fatigue, pain interference, pain intensity, and numbness and tingling"
15997123|NCT02912273|Other|Baseline Healthcare Provider Assessment|"Cognition: Orientation-Memory-Concentration Test which contains 6 questions that the provider will ask the participant. Form items 1-3, the response is either correct (score 0) or incorrect (score 1). For items 4-6, subtract one point for each error. Total score of 11 or greater indicates cognitive impairment (maximum score =28)
~Trail Making Test Part B - consists of 25 circles distributed over a sheet of paper. The circles include both numbers and letters; the participants draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letter. The test is timed.
~Timed Up and Go - the provider measures the time in seconds it takes for the participant to stand up from a standard arm chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down again."
15997124|NCT02912273|Other|Follow-up Participant Assessment|"Section 1 contains multiple choice questions about daily actives and several physical function questions
~Section 2 asks the participants how many medications they take on a daily basis, indicate any medication for depression, anxiety, nausea , and other stomach conditions
~Section 3 contains multiple questions asking about emotional distress/depression, fatigue, pain interference, pain intensity, and numbness and tingling"
15997125|NCT02912273|Other|Follow-up Healthcare Provider Assessment|"Trail Making Test Part B - consists of 25 circles distributed over a sheet of paper. The circles include both numbers and letters; the participants draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letter. The test is timed.
~Timed Up and Go - the provider measures the time in seconds it takes for the participant to stand up from a standard arm chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down again."
15997126|NCT02912273|Other|End-of-study Participant Assessment|"Section 1 contains multiple choice questions about daily actives and several physical function questions
~Section 2 asks the participants how many medications they take on a daily basis, indicate any medication for depression, anxiety, nausea , and other stomach conditions
~Section 3 contains multiple questions about the participant's concern about falling with answers ranging from 1=Not at all to 4=Very
~Section 4 contains multiple questions asking about emotional distress/depression, fatigue, pain interference, pain intensity, and numbness and tingling"
15997127|NCT02912273|Other|End-of-study Healthcare Provider Assessment|"Cognition: Orientation-Memory-Concentration Test which contains 6 questions that the provider will ask the participant. Form items 1-3, the response is either correct (score 0) or incorrect (score 1). For items 4-6, subtract one point for each error. Total score of 11 or greater indicates cognitive impairment (maximum score =28)
~Trail Making Test Part B - consists of 25 circles distributed over a sheet of paper. The circles include both numbers and letters; the participants draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letter. The test is timed.
~Timed Up and Go - the provider measures the time in seconds it takes for the participant to stand up from a standard arm chair, walk a distance of 3 meters, turn, walk back to the chair, and sit down again."
15997128|NCT02912260|Drug|MGL-3196|
15997129|NCT02912260|Drug|Placebo|
15997130|NCT02912247|Drug|human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection|human recombinant anti-tumor necrosis factor alpha monoclonal antibody injection, 40mg,subcutaneous injection,once
15997131|NCT02912247|Drug|adalimumab|adalimumab, 40mg,subcutaneous injection,once
15997132|NCT02912234|Drug|Apixaban|Multiple-dose clarithromycin and single-dose Apixaban
15997133|NCT02912234|Drug|Clarithromycin|Multiple-dose clarithromycin and single-dose Apixaban
15997134|NCT02912221|Other|Incentive|Both groups will receive fitbits to track their physical activity, however one arm of the study may receive additional incentives to achieve their step count goal.
15997135|NCT02912208|Drug|Eltrombopag/Revolade|Eltrombopag 50 mg once daily has been selected as the starting dose for this study. Thereafter, dependent on platelet response the dose of study medication can be increased by 50 mg every 2 weeks, up to a maximum dose of 300 mg once daily (150 mg in subjects of East Asian ethnicity).
15997136|NCT02912208|Other|Placebo|The administration is the same of eltrombopag
15997137|NCT02912195|Drug|Intravenous lidocaine|Intravenous lidocaine drip over 10 minutes followed by intravenous lidocaine drip over 50 minutes
15997138|NCT02912195|Drug|Intravenous morphine|Emergency department provider chooses appropriate dose of intravenous morphine
15997139|NCT02912182|Drug|Betamethasone|Betamethasone intravenous
15997140|NCT02912182|Drug|Placebo|Placebo intravenous NaCl intravenous administration Placebo tablets
15997142|NCT02912169|Procedure|Liposuction under local anesthesia|Procedure will be performed via liposuction to harvest Adipose-derived stromal vascular fraction cells.
15997143|NCT02912169|Biological|Infusion of AD-SVF via IV and Intranasal|IV and Intranasal Infusion of isolated AD-SVF
15997144|NCT02912156|Drug|Vaway FC Tablets 200mg (Voriconazole)|
15997145|NCT02912156|Drug|VFEND FC Tablets 200mg (Voriconazole)|
15997146|NCT02912143|Other|documentation only|
15997147|NCT02912130|Dietary Supplement|Protein Supplementation|1.2-1.5g/kg/body weight per day
15997148|NCT02912130|Other|Aerobic Exercise|30-60 minutes per week of moderate intensity exercise
15997149|NCT02912130|Other|Resistance Exercise|60 minutes per week of progressive resistance training
15997150|NCT02912104|Biological|human amniotic epithelial cells (hAECs) transplantation|hAECs are prepared and cultured using GMP(Good Manufacturing Practice, GMP) rules, 2×107 hAEC in 5ml sample is separately injected into ovarian tissue by bilateral ovarian artery infusion.
15997151|NCT02912078|Other|Pocket-warming|Pocket-warming of epidural medication
15997152|NCT02912078|Other|Standard of Care Labor Epidural|Labor epidural medication administered per standard of care; no pocket warming.
15997153|NCT02912052|Drug|Peri-operative chemotherapy|Patients receive 2 cycles of chemotherapy before surgery,and contniue to receive another 4 cycles of chemotherapy 21-28 days later after surgery.The chemotherapy regime is XELOX(oxaliplatin130mg/m2 ivd d1 + Capecitabine1000mg/m2 po bid d1-14, 21d/cycle)
15997154|NCT02912052|Drug|postoperative chemotherapy|Patients receive 6 cycles of chemotherapy 21-28 days later after surgery.The chemotherapy regime is XELOX(oxaliplatin130mg/m2 ivd d1 + Capecitabine1000mg/m2 po bid d1-14, 21d/cycle)
15997155|NCT02912039|Device|TetraGraph|A sequence of 3 sets of Train of four (TOF) stimuli delivered (every 20 sec) at the pre-determined current amplitude (for instance, 40 mA, then 30 mA, then 50 mA, then 20 mA).
15997156|NCT02912039|Device|TOF Watch|A sequence of 3 sets of TOF stimuli delivered (every 20 sec) at the pre-determined current amplitude (for instance, 40 mA, then 30 mA, then 50 mA, then 20 mA).
15997157|NCT02912026|Drug|IV F901318|Metabolic profile AUC 0 to infinity
15997158|NCT02912026|Drug|Oral F901318|Metabolic profile AUC 0 to infinity
15997159|NCT02912013|Device|Me Mini|Home use hair removal device
15997160|NCT02912000|Behavioral|TEACH intervention|The TEACH intervention screens family for three modifiable behaviors ahead of the clinical encounter: parental tobacco use, children consumption of sugar-sweetened beverages and child dental health. The information from the screening is then shared with clinicians.
15997161|NCT02911987|Other|high intensity training (HIT) program|The participants are randomly divided through use of sealed envelopes into four groups that all follow high intensity training (HIT) programs. Each training group follows of a 12 week program (2x/week, 2h). All training will be conducted under the guidance of expert therapists.
15997162|NCT02911987|Other|moderate intensity training (MIT) exercise therapy|MIT exercise consisting of a combination of previous programs (cardiovascular fitness, muscular fitness and general training specific trunk muscles) (the 'MIT' group).
15997163|NCT02911974|Device|Acquire EUS Biopsy Device|1. At EUS, once the pancreatic mass is identified, patients will be randomized to undergo sampling using the 22G Acquire EUS Biopsy Device or Expect EUS Aspiration Needle.
15997164|NCT02911974|Device|Expect EUS Aspiration Needle|1. At EUS, once the pancreatic mass is identified, patients will be randomized to undergo sampling using the 22G Acquire EUS Biopsy Device or Expect EUS Aspiration Needle.
15997165|NCT02911961|Drug|Acetaminophen|1 gram acetaminophen 4 times a day with at least 6 hour intervals between doses for the 3 days prior to the embolization procedure.
15997166|NCT02911948|Drug|Insulin degludec/liraglutide|Injected s.c. / subcutaneously (under the skin) once daily
15997167|NCT02911948|Drug|Insulin degludec|Injected s.c. / subcutaneously (under the skin) once daily
15997168|NCT02911935|Drug|Oral azithromycin|Oral azithromycin 10mg/kg/day for 7 days; then oral azithromycin 5mg/kg/day for 7 additional days
15997169|NCT02911935|Drug|Placebo|Placebo suspension
15997170|NCT02911922|Device|Endorectal Balloon|"Endorectal balloon (ERB): Immobilization device manually placed into the rectum prior to radiation treatment planning CT and daily treatment delivery, to immobilize the prostate and reduce prostate motion.
~Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days."
15997171|NCT02911922|Device|Rectal Spacer|"Rectal spacer (RS): Biodegradable gel that is transperineally injected between the rectum and prostate under transrectal ultrasound guidance, to increase physical distance and thereby reduce radiation dose to the anterior rectal wall. The spacer begins to biodegrade in 2-3 months, and is fully absorbed within 6 months.
~Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days."
15997172|NCT02911922|Radiation|Radiation therapy|Patients on each arm will receive 5 fractions of radiation, 7.25Gy per fraction, delivered 2-3 times a week (every other day excluding weekends), to total dose of 36.25 Gy. The total duration of treatment will be no shorter than 10 days.
15997173|NCT02911909|Device|Delfi|Patients will receive standard of care post-operative ACL reconstruction rehabilitation plus the Delfi moderated blood flow restriction therapy.
15997174|NCT02911909|Other|Standard rehabilitation|Patients will receive standard of care post-operative ACL reconstruction rehabilitation
15997175|NCT02911883|Device|Optical Coherence Tomography Angiography|
15997176|NCT02911870|Drug|SNAC|Oral administration
15997177|NCT02911870|Drug|Placebo|Oral administration
15997178|NCT02911870|Drug|Moxifloxacin|Oral administration
15997179|NCT02911857|Biological|Canakinumab (AIN457)|Canakinumab solution for subcutaneous injection in vial which contained 150mg/mL canakinumab in 1 mL solution
15997180|NCT02911844|Drug|Fulvestrant|Fulvestrant 500 mg administered intramuscularly into the buttocks slowly as two 5 mL injections, one in each buttock, on days 0, 14, 28 and 56. Fulvestrant 250 mg (one 5 mL injection) will be used in patients with Child-Pugh Class B liver disease.
15997181|NCT02911831|Drug|Tranexamic Acid|
15997182|NCT02911831|Drug|Sodium Chloride|
15997462|NCT02909686|Dietary Supplement|Reishi Mushroom|
15997463|NCT02909686|Dietary Supplement|Resveratrol|
15997183|NCT02911818|Behavioral|CMS-recommended lifestyle counseling|21 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
15997184|NCT02911818|Drug|Liraglutide 3.0mg|Liraglutide is a once-daily self-administered, subcutaneous (beneath the skin) injection.
15997185|NCT02911818|Other|Portion-Controlled Diet|A 1000-1200 kcal/day portion-controlled diet prescribed for 12 weeks.
15997186|NCT02911818|Drug|Placebo Oral Tablet|
15997187|NCT02911818|Drug|Phentermine 15 MG|
15997188|NCT02911818|Behavioral|Extension Study CMS-recommended lifestyle counseling|4 brief (15 minute) lifestyle counseling visits provided by a physician, nurse practitioner, or registered dietitian.
15997189|NCT02911805|Behavioral|Aerobic exercise|Stationary bicycle ergometer @ 50-80% of maximal heart rate reserve for 20 minutes to 45 minutes
15997190|NCT02911805|Behavioral|Balance exercise|Instructor-led exercises done in a group setting for strengthening, balance, flexibility
15997191|NCT02911792|Drug|Dapagliflozin|SGLT2 inhibitor
15997192|NCT02911792|Drug|Metformin|Oral diabetes medicine that helps control blood sugar levels.
15997193|NCT02911792|Drug|Glipizide 5 MG|Oral diabetes medicine that helps control blood sugar levels.
15997194|NCT02911779|Procedure|change of medilateral angle line during crowning of the head|change of medilateral angle line during crowning of the head
15997195|NCT02911766|Drug|Chlorhexidine 0.2% Mouthrinse|Intervention; Rinsing 60 sec with Comparator solution twice daily for 21 days
15997196|NCT02911766|Drug|Chlorhexidine 0.12% mouthrinse|Intervention; Rinsing 60 sec with Comparator solution twice daily for 21 days
15997197|NCT02911766|Drug|Chlorhexidine 0.06% mouthrinse|Intervention; Rinsing 60 sec with Comparator solution twice daily for 21 days
15997198|NCT02911753|Other|Mediterranean Lemonade|All participants will be advised to consume all of the beverage assigned (mediterranean lemonade) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided.
15997199|NCT02911753|Other|Green Tea|All participants will be advised to consume all of the beverage assigned (green tea) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided.
15997200|NCT02911753|Other|Flavored Water|All participants will be advised to consume all of the beverage assigned (flavored water) on a daily basis (rather than save up and consume large amounts on fewer days). The beverages will be prepared in advance by study personnel, refrigerated, and distributed to study participants on a weekly basis. Participants will be provided a daily 32-ounce beverage container for beverage consumption and instructed to clean the container nightly. Participants will also be asked to keep a log of completion of beverage on a daily basis and instructions regarding intake of other beverages will be provided.
15997201|NCT02911740|Other|Urine LAM Ag test|TB diagnostic assay
15997202|NCT02911727|Procedure|Fast-track discharge|As described above
15997203|NCT02911714|Drug|Lumason Contrast-Enhanced Ultrasound|In both arms, we will use Lumason to measure kidney allograft perfusion via contrast-enhanced ultrasound.
15997204|NCT02911701|Drug|Acetaminophen|
15997205|NCT02911701|Drug|Ibuprofen|
15997206|NCT02911688|Drug|gamma tocopherol|The effect of supplemental with gamma tocopherol on O3 response will be assessed using the difference pre and after γT dosing.
15997207|NCT02911688|Drug|Placebo|The effect of supplemental with gamma tocopherol on O3 response will be assessed using the difference pre and after placebo dosing.
15997208|NCT02911675|Device|EVD/IVC and the IPM/Camino|This is an interventional device study utilizing the EVD/IVC and the IPM/Camino to provide and evaluate data for optimized treatment for the control of elevated ICP and CCP in patients with severe TBI.
15997209|NCT02911662|Drug|Cephalexin|Cephalexin will be prescribed for women with a positive urine culture but no symptoms of urinary tract infection.
15997210|NCT02911662|Drug|Nitrofurantoin|Macrobid will be prescribed for women allergic to penicillin with a positive urine culture but no symptoms of urinary tract infection.
15997211|NCT02911649|Other|Wearable Technology - Garmin Vivosmart|Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.
15997212|NCT02911649|Other|Online Educational Group|A workshop leader will lead participants through an educational workshop and group discussion on topics related to reducing sedentary behaviour
15997213|NCT02911649|Other|Wearable Technology - FitBit Alta|Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.
15997214|NCT02911649|Other|Wearable Technology - Polar Loop 2|Wearable devices will be used to show participants their activity levels daily, as well as weekly overview of their activity levels.
15997215|NCT02911636|Radiation|Pelvic SABR with intra-prostatic SABR|described elsewhere
15997216|NCT02911623|Device|Shockwave Lithoplasty® System|The Shockwave Lithoplasty® System is a proprietary lithotripsy-enhanced balloon catheter that is designed to be delivered through the peripheral arterial system of the lower extremities to the site of calcified stenosis. Activating the lithotripsy within the device will generate pulsatile mechanical energy within the target treatment site, disrupt calcium within the lesion and allow subsequent dilation of a peripheral artery stenosis using low balloon pressure. The system consists of a balloon catheter with multiple integrated lithotripsy electrodes, and a generator.
15997217|NCT02911610|Device|arthroscopy + volar plate|surgery of wrist fractures with volar plate and added arthroscopy
15997218|NCT02911610|Device|Volar plate|surgery of wrist fractures with volar plate
15997219|NCT02911597|Drug|Naltrexone|adding naltrexone (or placebo) to a ketamine infusion to potentially block the effects of ketamine as an anti depressant.
15997220|NCT02911584|Procedure|Laparoscopic procedure|
16051552|NCT02514681|Drug|Eribulin|
15997221|NCT02911571|Device|MMprofiler SKY92 gene signature|"MMprofiler is a gene expression assay system for detection of the presence (or absence) of the SKY92 high-risk gene signature to aid in the determination of the Multiple Myeloma patient's prognosis"
15997222|NCT02911532|Procedure|Tissue engineering conjunctiva transplantation|During the operation,transplant the tissue engineering conjunctiva to the conjunctiva loss position
15997223|NCT02911519|Other|Brief Group Psychoeducation|First session: describe the clinical manifestations of schizophrenia, deny myths, and inform on the biological nature of the disorder. Second session: provide updated information regarding pharmacological treatment, their side effects and the importance of adherence to treatment. Third session: Achieving recognition of personal responsibility for the lifestyle, routine, physical care and the risk of addiction; awareness of the importance of self-monitoring of symptoms and the development of cognitive, behavioral and emotional strategies. Fourth Session: To recognize the role of family members in the treatment, the problem of expressed emotions and communication in times of crisis. Fifth Session: To know the rights and duties of patients and their families in the current health care system.
15997224|NCT02911519|Other|Treatment as Usual|The patients in both arms of the intervention will receive this type of attention. The TAU is the psychiatric care that patients with schizophrenia usually receive in the clinic. This is done in consultation of 30 minutes, in which the psychiatrist evaluates the clinical condition of the patient and psychosocial factors that may be affecting, prescribes drugs according to protocols and clinical care and answers questions about the disorder. In the consultation a brochure with information is given about schizophrenia. The frequency of consultations varies depending on severity of symptoms usually split between one and six months.
15997225|NCT02911506|Other|Polysomnography|
15997226|NCT02911493|Behavioral|Reducing Sedentary Behavior|The experimental group will wear an activPAL and have counseling sessions that use the Health Belief Model and Motivational Interviewing strategies to reduce sedentary time.
15997227|NCT02911493|Behavioral|Physical Activity Group|The Active Comparative group will wear an activPAL and have counseling sessions that use the Health Belief Model and Motivational Interviewing strategies to increase exercise time.
15997228|NCT02911480|Drug|Oxytocin|
15997229|NCT02911467|Drug|Pyruvate (13C)|Pyruvate injection followed by an MRI scan.
15997230|NCT02911467|Device|MRI|MRI scan following the Pyruvate injection
15997231|NCT02911454|Other|Infant formula|
15997232|NCT02911441|Behavioral|Cognitive Behavioral Therapy|
15997233|NCT02911428|Procedure|blood sampling collection|It is an observational study; no interventions are planned in the course of common clinical practices during the study period; investigated therapeutic agents or special methods of examination will not be used in the study, except the blood sampling procedure and clinical observation specified in this Protocol.
15997234|NCT02911415|Procedure|blood sampling collection|It is an observational study; no interventions are planned in the course of common clinical practices during the study period; investigated therapeutic agents or special methods of examination will not be used in the study, except the blood sampling procedure and clinical observation specified in this Protocol.
15997235|NCT02911402|Other|sea sickness questionnaires|
15997236|NCT02911389|Other|Home PT via web-based platform|
15997237|NCT02911389|Other|Home PT via paper manual|
15997238|NCT02911389|Other|outpatient PT|
15997239|NCT02911363|Device|Captivator cassette|The Captivator tissue cassette has an effect on the preservation of tissue histology.
15997240|NCT02911363|Other|Standard of Care|The specimen will be processed following the College of American Pathology Standards.
15997241|NCT02911350|Drug|Hormone Suppressors|
15997242|NCT02911350|Drug|Paclitaxel|
15997243|NCT02911350|Radiation|Radiation Therapy|
15997244|NCT02911337|Dietary Supplement|lifestyle modification|Subjects will be given meal replacements (shakes and bars) to be consumed twice per day for 8 weeks, and then once per day for an additional 3 weeks, and then transitioned to a structured diet.
15997245|NCT02911324|Drug|Nabilone|"Nabilone is a synthetic cannabinoid that is thought to be a Cannabinoid receptor type 1 (CB 1) agonist. It acts on the brain's endocannabinoid system, which has been hypothesized to play a role in OCD."
15997246|NCT02911324|Behavioral|Exposure and Response Prevention Therapy|Exposure and Response Prevention Therapy (EX/RP) is a type of Cognitive-Behavioral Therapy for OCD that involves intentionally confronting situations that trigger obsessional distress while refraining from doing compulsions.
15997247|NCT02911311|Drug|intravitreal injection of conbercept|conbercept is an anti-VEGF agent and is approved by the Food and Drug Administration for wet age-related macular degeneration
15997248|NCT02911311|Device|PRP|panretinal photocoagulation (PPR) is the standard treatment for proliferative diabetic retinopathy (PDR) and is applied to the peripheral retinal tissue to ablate areas of the peripheral retina and thereby reduce retinal oxygen consumption
15997249|NCT02911298|Drug|Metronidazole Benzoate gastro-resistant capsule with radio-labelled mucoadhesive formulation|
15997250|NCT02911298|Drug|Metronidazole Benzoate gastro-resistant capsule with radio-labelled non-mucoadhesive formulation|
15997251|NCT02911285|Drug|N-acetylcysteine|1200mg bid (2400mg/day)
15997252|NCT02911285|Drug|Placebo|Placebo pills bid
15997253|NCT02911285|Behavioral|Cognitive behavioral therapy|CBT for AUD/SUD, one hour/once a week
15997254|NCT02911272|Device|2-hour action line on WHO modified partograph|observations and findings in a woman in labour are recorded on this device (WHO modified partograph) in a graphic format in which the action line is located 2-hour from the alert line
15997255|NCT02911272|Drug|Oxytocin|Oxytocin augmentation of slow labour progress at the respective action line location on the WHO modified partograph
15997256|NCT02911272|Procedure|Forewater amniotomy|Forewater amniotomy at the vaginal examination confirming active phase labour
15997257|NCT02911272|Device|4-hour action line on WHO modified partograph|observations and findings in a woman in labour are recorded on this device (WHO modified partograph) in a graphic format in which the action line is located 4-hour from the alert line
15997258|NCT02911259|Device|Suction is set to -2 cmH2O|Post-operative suction is set to -2 cmH2O (intervention).
15997259|NCT02911259|Device|Suction is set to -10 cmH2O|Post-operative suction is set to -10 cmH2O (standard treatment).
15997260|NCT02911233|Biological|Thromboelastograpgy|
15997464|NCT02909686|Dietary Supplement|Placebo|
16051553|NCT02514681|Drug|Capecitabine|
15997261|NCT02911220|Genetic|demonstration of genetic mutations causing non-atopic asthma|recruitment of familial forms of non-atopic asthma (patients with non-atopic asthma and their relatives) to perform genetic analysis of exome sequencing
15997262|NCT02911207|Behavioral|patients choose one creative activity and one physical activity|taking part in 2 activities (a creative one and a physical one)
15997263|NCT02911194|Dietary Supplement|a2 milk|replace all milk with a2 milk
15997264|NCT02911194|Dietary Supplement|a1 containing milk|use a1 containing milk
15997265|NCT02911181|Other|BIVA measurement|
15997266|NCT02911168|Procedure|Proximal Intercostal Block|After identifying the correct intercostal space, the ultrasound probe will be moved medially to identify the transverse processes, then again laterally from the transverse processes to rest over the ribs so as to obtain the best view of ribs and pleura. A 10cm, 21G needle will be inserted in-plane at the caudal border of the probe. An attempt will be made to keep the needle tip and the target injection position (just under the internal intercostal membrane (IIM)) in view. Correct needle tip placement will be demonstrated by depression of the pleura/endothoracic fascia upon local anesthetic injection and by lack of retrograde spread of LA over the muscles or the ribs. The LA will be injected in 4 cc aliquots after negative aspiration of air, CSF and blood.
15997267|NCT02911168|Procedure|Paravertebral Block|After identifying the correct intercostal space, the ultrasound probe will be placed between the adjacent transverse processes in a longitudinal/parasagittal plane measuring 2.5cm from the midline. The best possible view of the transverse processes, the superior costotransverse ligament and pleura will be obtained. An attempt will be made to keep the needle tip and the target injection position (immediately beneath the costotransverse ligament) in view. Correct placement of the needle tip will be demonstrated by depression of the pleura upon injection of local anesthetic and by lack of retrograde spread of LA over the muscles or transverse processes. The LA will be injected in 4 cc aliquots after confirming negative aspiration of air, CSF and blood.
15997268|NCT02911142|Drug|Lenalidomide|Lenalidomide taken orally, daily at assigned dose level on days 1 to 10, up to 25mg.
15997269|NCT02911142|Drug|Rituximab|During cycle 1, rituximab will be administered on day 4 prior to the start of EPOCH. During cycles 2 to 6, rituximab will be administered on day 1 of each cycle.
15997270|NCT02911142|Drug|Prednisone|During cycle 1, Prednisone 60 mg/m2 /day PO days 6 to 10. During cycles 2-6, Prednisone 60 mg/m2 /day PO days 1-5.
15997271|NCT02911142|Drug|Etopside|During cycle 1, Etoposide 50 mg/m2 /day continuous intravenous infusion days 6 to 9. During cycles 2-6, Etoposide 50 mg/m2/day continuous intravenous infusion days 1 to 4.
15997272|NCT02911142|Drug|Doxorubicin|During cycle 1, Doxorubicin 10 mg /m2/day continuous intravenous infusion days 6 to 9. During cycles 2-6, Doxorubicin continuous intravenous infusion days 1 to 4.
15997273|NCT02911142|Drug|Vincristine|During cycle 1, Vincristine 0.4 mg/m2 /day continuous intravenous infusion days 6 to 9. During cycles 2-6, Vincristine continuous intravenous infusion days 1 to 4.
15997274|NCT02911142|Drug|Cyclophosphamide|During cycle 1, Cyclophosphamide 750 mg/m2 day 10. During cycles 2-6, Cyclophosphamide 750 mg/m2 day 5.
15997275|NCT02911116|Drug|Ustekinumab|Subcutaneous Injection
15997276|NCT02911116|Drug|Ustekinumab|Intravenous Infusion
15997277|NCT02911103|Procedure|DBS surgery|Unilateral thalamic DBS therapy
15997278|NCT02911090|Other|Data Registry|Data Registry
15997280|NCT02911051|Device|Actreen Hydrolite Cath|Depending of the use of the self catheterized patient could be 4 to 6 Actreen Hydrolite Cath per day
15997281|NCT02910986|Behavioral|Written educational brochure|Written educational brochure about breast density
15997282|NCT02910986|Behavioral|Promotora interaction|Promotora education about breast density
15997283|NCT02910973|Device|Vagus Nerve Stimulation|Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes. Blood will be withdrawn prior to stimulation and 1 hour following the stimulation. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch of the vagus nerve.
15997284|NCT02910973|Device|Sham Vagus Nerve Stimulation|Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes. Blood will be withdrawn prior to stimulation and 1 hour following the stimulation. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
15997285|NCT02910960|Device|Acquire EUS Biopsy Device|At EUS, once the pancreatic mass is identified, patients will be randomized to undergo sampling using the 22G Acquire EUS Biopsy Device or SharkCore Biopsy System.
15997286|NCT02910960|Device|SharkCore Biopsy System|At EUS, once the pancreatic mass is identified, patients will be randomized to undergo sampling using the 22G Acquire EUS Biopsy Device or SharkCore Biopsy System.
15997287|NCT02910947|Procedure|ultrasound guided quadratus lumborum or Transversus Abdominis plane block|The intervention consists of giving ultrasound guided local anaesthetic (0.125% bupivacaine ) in the quadratus lumborum plane or the transversus abdominis plane after randomization. These planes and technique for these procedures are well described in literature.
15997288|NCT02910934|Other|Actellic CS|Indoor residual spray with Actellic CS
15997289|NCT02910895|Other|tumor biopsy|biopsy
15997290|NCT02910882|Drug|PEGylated Recombinant Human Hyaluronidase (PEGPH20)|"PEGPH20 Dosing (Cohort I, Dose Escalation, First 3 patients): Administered as an IV infusion over 10 minutes (+/- 2 Minutes), approximately 1mL/minute:
~Dose level 1 - 1 mcg/kg; Dose level 2 - 1.6 mcg/kg; Dose level 3 - 3 mcg/kg.
~PEGPH20 Dosing (Cohort II, Patients 4-10): Administered at a dose of 3 mcg/kg as an IV infusion over 10 minutes (+/- 2 Minutes), approximately 1mL/minute.
~Dosing Schedule: Twice per week beginning Day #1 for 8 doses, then weekly until end of radiotherapy."
15997574|NCT02908776|Other|Placebo|Sachets of maltose, flavors and sylicium dioxide, indistinguishable from ecoviesel sachets.
15997291|NCT02910882|Drug|Gemcitabine|"Gemcitabine Dosing: Administered at a dose of 600 mg/m2 as an IV infusion over 30 - 60 minutes with standard antiemetic pre-medication. If administered on PEGPH20 day, Gemcitabine will be infused 2-4 Hours after PEGPH20 infusion is completed.
~Dosing Schedule: Weekly, beginning Day #2, per standard regimen."
15997292|NCT02910882|Radiation|Radiation|Radiotherapy, beginning Day #2, delivered at 1.8 Gy per fraction, 5 fractions per week (Monday - Friday), until a total dose of 50.4 to 54 Gy for up to 6 Weeks.
15997293|NCT02910869|Genetic|Pathway Genomics FIT test|
15997294|NCT02910843|Drug|Regorafenib|"Regorafenib dosel level 1-3: day 1 to 14 and day 22 to 35 (2 weeks on 1 week off, 2 weeks on, including Saturday and Sunday) at a daily dose according to the escalation table.
~Regorafenib dosel level -1: day 1 to 5, day 8 to 12, day 22 to 26 and day 29 to 33 (5 days on and 2 days off during week 1, 2, 4 and 5; week 3 off) at a daily dose according to the escalation table."
15997295|NCT02910843|Drug|Capecitabine|• Capecitabine: day 1 to 38 (5 weeks and 3 days, including Saturday and Sunday) according to dose escalation table. The intake stops in the evening of the last day of RT.
15997296|NCT02910843|Radiation|Radiotherapy|Monday through Friday for 5 weeks and 3 days (d1-38) starting on day 1 (daily fraction 1.8 Gy, final dose 50.4 Gy).
15997297|NCT02910843|Procedure|Surgery|6-12 weeks (± 1 week) after radio-chemotherapy (RCT) has been completed (42-84 days after last day of RCT).
15997298|NCT02910817|Drug|Metformin|The metformin-treated group received metformin (1000 mg per day) with the start of controlled ovarian stimulation (COH) until the day of the pregnancy check.
15997299|NCT02910817|Other|Placebo|Placebo
15997300|NCT02910804|Drug|68Ga-BBN-IRDye800CW|
15997301|NCT02910804|Device|PET/NIRF|
15997302|NCT02910804|Procedure|PET/NIR fluorescent imaging-guided surgery|
15997304|NCT02910778|Drug|Atorvastatin|Subjects will receive 80 mg atorvastatin once daily for 14 days (until study day 15). On study day 15, 80 mg atorvastatin in combination with a loading dose of 180 mg ticagrelor will be administered.
15997305|NCT02910778|Drug|Placebo|Subjects will receive placebo once daily for 14 days (until study day 15). On study day 15, placebo in combination with a loading dose of 180 mg ticagrelor will be administered.
15997306|NCT02910778|Drug|Ticagrelor|
15997307|NCT02910765|Drug|methylene blue|
15997308|NCT02910765|Drug|ozone|
15997309|NCT02910765|Other|saline infusion|
15997310|NCT02910765|Other|oxygen|
15997311|NCT02910752|Drug|CLAM+PBSC|Cladribine 5mg/m2 + cytarabine 1.5g/m2 + mitoxantrone 10mg/m2 from D1 to D5
15997312|NCT02910739|Drug|MK-8931|MK-8931 40 mg
15997313|NCT02910726|Procedure|Sentinel Lymph Node Biopsy|
15997314|NCT02910726|Drug|indocyanine green (ICG)|
15997315|NCT02910713|Device|Intranasal Tear Neurostimulator|The device delivers small electrical currents, activating nerves that stimulate the body's natural tear production system.
15997316|NCT02910700|Drug|Binimetinib|Given PO
15997317|NCT02910700|Drug|Dabrafenib|Given PO
15997318|NCT02910700|Drug|Encorafenib|Given PO
15997319|NCT02910700|Other|Laboratory Biomarker Analysis|Correlative studies
15997320|NCT02910700|Biological|Nivolumab|Given IV
15997321|NCT02910700|Other|Pharmacological Study|Correlative studies
15997322|NCT02910700|Drug|Trametinib|Given PO
15997323|NCT02910687|Other|This is an observational study|
15997324|NCT02910674|Device|Dario Blood Glucose Monitoring System|Accuracy with usability assessment
15997325|NCT02910661|Other|Focus Group|Concurrently at each site, an experienced facilitator, having no direct affiliation with the clinical team, will use standardized stakeholder-specific, semi-structured scripts (designed with patient and parent collaborators) to conduct the patient, parent, and HCP focus groups. The TAKE-IT intervention will be described, and Simplemed e-pillbox shown, to all focus groups. Questions posed to the patient and parent focus groups will focus on 2 themes: the intervention and electronic monitoring. Example stakeholder-specific scripts to guide the discussions are appended. Each focus group will last ~90 min. and be audio-recorded. An observer will take field notes.
15997326|NCT02910648|Behavioral|Modified Go/No-Go Task|Participants in the experimental group and control sham sound cues group will complete a computerized training task to facilitate learning to respond (press a computer key) to healthy food stimuli and to inhibit responses (not press a computer key) to unhealthy food stimuli. Participants in the control sham go/no-go group will complete a similar task with common office supplies (approach) and tools (inhibit). All participants will also complete a 24 hour dietary recall as described below.
15997327|NCT02910635|Drug|Volanesorsen|ISIS 304801 is supplied as 200mg of volanesorsen with 1.0mL of solution per vial
15997328|NCT02910635|Drug|Moxifloxacin|Moxifloxacin Hydrochloride 400 mg tablet administered orally, Single Dose
15997329|NCT02910635|Drug|Placebo|
15997330|NCT02910622|Other|Chimio-oncogramme|Cells fragment are cultured for 7 days. The effects of chemotherapy are studied on these cells through chimio-oncogramme.
15997331|NCT02910609|Device|Echocardiography|Echocardiography is a kind of ultrasound test that shows the inner structure and functions of the heart in both groups.
15997332|NCT02910596|Drug|bethanechol chloride|bethanechol chloride(10) 2 tablets oral tid, ac. Start on3rd - 5th postoperative day
15997333|NCT02910596|Device|early bladder training|early bladder training start on 3rd - 5thpostoperative day
15997334|NCT02910596|Other|early bladder training and bethanechol chloride|bethanechol chloride 2 tablets oral tid, ac and early bladder training start on 3rd - 5th postoperative day
15997335|NCT02910596|Other|no early bladder training and no bethanechol chloride|no bethanechol chloride and no early bladder training
15997336|NCT02910583|Drug|ibrutinib|ibrutinib 420mg capsules administered orally once daily
15997337|NCT02910583|Drug|placebo to match ibrutinib|placebo capsules to match ibrutinib administered orally once daily
15997338|NCT02910583|Drug|venetoclax|venetoclax tablets will be administered orally once daily starting with a 5 week ramp up of 20 mg, 50 mg, 100 mg, 200 mg and 400 mg. After ramp up, venetoclax will be administered at 400 mg.
15997339|NCT02910570|Drug|Liraglutide 3 mg (Saxenda)|Dose escalation scheme: Initial dosage of 0.6 mg per day, escalated bi-weekly by 0.6 mg to 3 mg per day over a total of 8 weeks
15998171|NCT02903849|Behavioral|Drafting Motivational Messages|Write down three motivating messages
15997340|NCT02910570|Drug|Liraglutide 3 mg placebo|Dose escalation scheme: Initial dosage of a 0.6 mg drug equivalent volume per day, escalated bi-weekly by an 0.6 mg drug equivalent volume per day to a 3 mg drug equivalent volume per day over a total of 8 weeks.
15997341|NCT02910544|Dietary Supplement|Intensive dietary intervention|Participants receive a hypo-caloric formula diet containing 800 to 1,000 kcal/day. The formula diet consists of ready-to-use meal bars and powders to mix with water to make shakes, soups, or porridge. The weight loss programme consists of an 8-week period with full meal replacement by a standard liquid energy intake protocol. To facilitate compliance with the programme, participants will be scheduled for weekly facility-based group sessions with 6-8 participants led by a dietician. The recommendations for daily nutrient intake will be met.
15997342|NCT02910531|Dietary Supplement|Alpha lipoic acid|Already mentioned in arm/group descriptions.
15997343|NCT02910531|Drug|Placebo|Already mentioned in arm/group descriptions.
15997344|NCT02910518|Drug|Insulin glulisine (U300)|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
15997345|NCT02910518|Drug|Insulin glulisine|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
15997346|NCT02910518|Drug|Insulin aspart|"Pharmaceutical form: solution
~Route of administration: intravenous/subcutaneous"
15997347|NCT02910518|Drug|NPH insulin|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
15997348|NCT02910518|Drug|Glucagon|"Pharmaceutical form: Powder and solvent for solution for injection
~Route of administration: subcutaneous"
15997349|NCT02910518|Drug|Glucose|"Pharmaceutical form: solution
~Route of administration: intravenous"
15997350|NCT02910518|Drug|Heparin|"Pharmaceutical form: solution
~Route of administration: intravenous"
15997351|NCT02910505|Device|enLighten Laser|Laser for tattoo removal
15997352|NCT02910492|Device|enLighten Laser|Nd:YAG dual-pulse duration laser for the treatment of skin rejuvenation
15997353|NCT02910479|Device|E-Celsius thermometer|comparison of temperature between e-celsius and thermometer, rectal thermometer, esophageal thermometer, vital sense capsule thermometer
15997354|NCT02910479|Device|Rectal thermometer|
15997355|NCT02910479|Device|Esophageal thermometer|
15997356|NCT02910479|Device|Vital sense capsule thermometer|
15997357|NCT02910466|Drug|rhPTH(1-84)|Participants will receive 25, 50, 75, and 100 microgram (mcg) of rhPTH(1-84) subcutaneous injection to the thigh via a multidose pen injector device once daily for 36 months. The dose will be individualized based on Albumin-corrected Serum Calcium (ACSC) and 24-hour calcium urinary excretion to achieve a serum calcium level in the lower half of the normal range.
15997358|NCT02910453|Procedure|Pulmonary lobectomy|
15997359|NCT02910440|Drug|DCL-101 vs Golytely|
15997360|NCT02910427|Other|Regular salt|Participants eat a regular salt diet.
15997361|NCT02910427|Other|Potassium-enriched salt|Participants eat a potassium-enriched salt diet.
15997362|NCT02910427|Other|Potassium and magnesium-enriched salt|Participants eat a potassium and magnesium-enriched salt diet.
15997363|NCT02910414|Drug|Dehydrated alcohol|Dehydrated Alcohol Injection, USP is used in the study.
15997364|NCT02910414|Device|Peregrine System Kit (Sham Procedure)|Pre-procedural diagnostic renal angiography only, performed for confirmation of anatomical eligibility prior to randomization
15997365|NCT02910401|Biological|Rhinovirus (GMP RV16 HRV-16)|300 tissue culture infectious dose (TCID)50 mg/ml intranasal one time only
15997366|NCT02910388|Device|LLETZ with colposcopy|Loop procedure using a colposcope in order to see and remove the abnormal cervical tissue
15997367|NCT02910388|Other|LLETZ without colposcopy|Loop procedure without using a colposcope
15997368|NCT02910375|Other|Cohort A|Venous sampling (n=13) will be performed in the hospital at D0 (prior to first golimumab injection), D3, D7, D14 (prior to second injection), D28, M0D0 (right before injection at week 6), M0D3, M0D7, M1D0 (4 weeks after M0D0, week 10), M1D3, M1D7, M2D0 (8 weeks after M0D0, week 14), M3D0 (12 weeks after M0D0, week 18) Dried blood spot sampling (n=39) will be performed at D0 (prior to first golimumab injection), D1, D2, D3, D4, D5, D6, D7, D10, D14, D15, D16, D17, D18, D19, D20, D21, D28, D35, M0D0 (right before injection at week 6), M0D3, M0D7, M1D0 (4 weeks after M0D0, week 10), M1D1, M1D3, M1D5, M1D7, M1D9, M1D14, M1D21, M2D0 (8 weeks after M0D0, rig week 14), M2D1, M2D3, M2D5, M2D7, M2D9, M2D14, M2D21, M3D0 (12 weeks after M0D0, week 18)
15997369|NCT02910375|Other|Cohort B|Venous sampling (n=8) will be performed at M0D0 (right before new golimumab injection), M0D3, M0D7, M1D0 (4 weeks after M0D0, right before next injection), M1D3, M1D7, M2D0 (8 weeks after M0D0, right before next injection), M3D0 (12 weeks after M0D0, right before next injection) Dried blood spot sampling (n=20) will be performed at M0D0 (right before new golimumab injection), M0D3, M0D7, M1D0 (4 weeks after M0D0, right before next injection), M1D1, M1D3, M1D5, M1D7, M1D9, M1D14, M1D21, M2D0 (8 weeks after M0D0, right before next injection), M2D1, M2D3, M2D5, M2D7, M2D9, M2D14, M2D21, M3D0 (12 weeks after M0D0, right before next injection)
15997370|NCT02910362|Device|Alcon phacoemulsification equipment|cataract surgery with Alcon phacoemulsification equipment.
15997371|NCT02910362|Device|AMO phacoemulsification equipment|cataract surgery with AMO phacoemulsification equipment.
15997372|NCT02910336|Other|Quantitative Sensory Testing|sensory testing profile
15997373|NCT02910310|Other|Uterine balloon tamponade|An intervention consisting of inserting a condom attached to a urinary catheter into the uterus and inflating it with fluid to stop postpartum bleeding
15997374|NCT02910284|Biological|Observational|
15997375|NCT02910245|Drug|Mercaptopurine (Purinethol)|
15997376|NCT02910245|Drug|Placebo|
15997377|NCT02910245|Drug|Mesalamine|
15997378|NCT02910245|Drug|Prednisone|
15997379|NCT02910232|Device|bone void filler|Bone void filler device prepared from porous starch-hydroxyapatite composites for bone regeneration
15997380|NCT02910219|Drug|Crofelemer|Crofelemer 125 mg BID during cycles 1-2 of THP or TCHP
15997381|NCT02910206|Drug|Etomidate|etomidate is given intravenously
15997382|NCT02910206|Drug|propofol|propofol is given intravenously
15997383|NCT02910206|Drug|Sufentanil|sufentanil is given intravenously
15997384|NCT02910206|Drug|Cisatracurium|Cisatracurium is given intravenously
15997385|NCT02910167|Drug|Hyoscine n-butylbromide|Hyoscine n-butylbromide 10 mg
15997386|NCT02910167|Drug|Paracetamol|Paracetamol 500 mg
15997387|NCT02910167|Drug|Hyoscine n-butylbromide|Hyoscine n-butylbromide 10 mg
15997389|NCT02910154|Dietary Supplement|Diet|Weight loss achieved by following an evidence-based low energy diet of 800-1200 kcal/day for 12 weeks (Cambridge Weight Plan). Hereafter follow 12 weeks of 'weight maintenance' with consumption of normal heart healthy diet. Goal: total weight loss of at least 10% without significant loss of muscle mass. Monitored and supervised by a dietician
15997390|NCT02910154|Behavioral|Training|Aerobic interval training and resistance exercise in group sessions twice weekly throughout the 24-week intervention. Training intensity individually adapted to the restricted calorie intake. Goal: Improved VO2 peak (at least 10%). Monitored by a physiotherapist.
15997391|NCT02910154|Drug|Medication (with statin and ACE-inhibition)|Medical treatment for hypertension and/or hypercholesterolemia if systolic blood pressure > 130 and/or low density lipoprotein (LDL) > 2.0.
15997392|NCT02910141|Device|Continuous subcutaneous insulin infusion|Infusion of short-acting insulin from a portable pump
15997393|NCT02910128|Behavioral|chiquichefs|A project based learning using healthy trough cooking as the core of the curriculum, so children learn the academic content through cooking workshop of mediterranean diet in their school.
15997394|NCT02910115|Other|Cold laparotomy sponges|Cold laparotomy sponges are lap sponges that are saturated in sterile, iced normal saline
15997395|NCT02910115|Drug|Pitocin|Pitocin is administered intravenously according to the usual protocol.
15997396|NCT02910102|Drug|RVT-101 35 mg|RVT-101 once daily, oral, 35-mg tablets
15997397|NCT02910102|Drug|Placebo|Placebo once daily, oral
15997398|NCT02910089|Behavioral|Shared Decision Making|This prospective study will include 700 beneficiaries of Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ).
15997399|NCT02910076|Drug|Hydroxychloroquine|200 MG Plaquenil three times a day
15997400|NCT02910063|Drug|Blinatumomab|Blinatumomab monotherapy
15997401|NCT02910050|Drug|Bicalutamide|50mg once a day orally
15997402|NCT02910050|Drug|Aromatase Inhibitor|participants will receive any kind of aromatase inhibitor which has not been received before (steroidal AI change to nonsteroidal AI and vice versa), Letrozole 2.5mg once a day orally, Anastrozole 1mg once a day orally, Exemestane 25mg once a day orally
15997403|NCT02910037|Device|mNGS for pathogen detection|This assay is a laboratory-validated metagenomic test for comprehensive detection of viruses, bacteria, fungi, and parasites in clinical samples.
15997404|NCT02910024|Device|Magstim Super Rapid2 System, intermittent theta-burst-stimulation (iTBS) protocol|iTBS applied over ipsilesional M1
15997405|NCT02910024|Device|Magstim Super Rapid2 System, sham-stimulation (in iTBS)|iTBS applied with tilted coil over parieto-occipital vertex
15997406|NCT02910011|Drug|Nanodox 1% (doxycycline monohydrate hydrogel)|Subjects will be asked to apply NanoDOX® Hydrogel 1% once daily at bedtime for up to four weeks or until complete clearance whichever is sooner
15997407|NCT02909998|Other|Blood sample|Conservation at the end of the blood sample
15997408|NCT02909985|Other|Tungsten halogen light with narrow bandpass filters|As intensity in increased from 0 to 12 V, participants will say if/when they see a visual response to infrared light from a broad band tungsten halogen light source that passes through narrow bandpass filters ranging from 850 nm to 1400 nm. At the end of three trials per filter, the intensity will be turned up to 12 V, and participants will describe the color they see.
15997409|NCT02909985|Other|ERG|Participants will undergo electroretinography using both normal settings and infrared as the stimuli.
15997410|NCT02909985|Other|VEP|Participants will undergo visual evoke potential tests using both normal settings and infrared as the stimuli.
15997411|NCT02909972|Drug|ALRN-6924|Fixed dose of ALRN-6924 per cohort, administered IV, Days 1, 8, and 15 every 28 days.
15997412|NCT02909972|Drug|ALRN-6924 in combination with cytarabine|Cytarabine (100 or 200 mg/m2) will be administered as an IV infusion followed by ALRN-6924 on Days 1, 8, and 15 every 28 days.
15997413|NCT02909959|Drug|Sulforaphane|The investigational medicinal product is an uncoated tablet containing both glucoraphanin and myrosinase, the enzyme that converts glucoraphanin to sulforaphane in vivo. Participants in this arm will take 3-8 tablets by mouth once daily (dose depending upon weight) for 12 weeks.
15997414|NCT02909959|Drug|Placebo|Placebo tablets are uncoated and matched in appearance to the investigational medicinal product, containing inert components. Participants in this arm will take 3-8 tablets by mouth once daily (dose depending upon weight) for 12 weeks.
15997415|NCT02909946|Behavioral|Multi-modal Infection Control Program|"Standard precautions and hand hygiene for care of all residents. Enhanced barrier precautions including hand hygiene, glove use, and gown use for HCW when providing ADL assistance for residents at highest-risk (caregiver intervention).
~Hand hygiene education to residents and families (resident-level intervention).
~Standardized bathing practices including using chlorhexidine-based cloths to reduce resident MDRO colonization (resident-level intervention).
~Standardized environmental protocol and education to reduce contamination on inanimate objects and surfaces (environmental intervention).
~Feedback monthly of facility-level microbial data and new MDRO acquisition rates to infection control practitioners, HCWs, and facility leadership (facility intervention)."
15997416|NCT02909933|Drug|liraglutide|
15997417|NCT02909933|Drug|metformin and liraglutide|
15997418|NCT02909920|Other|Telerehabilitation|Initial Videoconference following telerehabilitation programs self-workout exercise with video support.
15997419|NCT02909920|Other|Traditional Physiotherapy|Traditional Physiotherapy receives assistance in a physiotherapy center with personalized therapy consisting of 1 to 1 with a physical therapist (Manual Therapy, home exercise programs and other physiotherapy techniques).
15997420|NCT02909907|Drug|Botulinum toxin|Botulinum injections into dominant upper extremity using protocol outlined above.
15997421|NCT02909907|Other|Placebo|Placebo injections in extensor carpi radialis (ECR) and extensor carpi ulnaris (ECU) per protocol outlined above
15997422|NCT02909894|Other|Prolonged Sitting|Condition A is referred to as the 'sitting' condition. Here participants will remain seated throughout the whole of the 7 ½ hour test period (8am - 3:30pm). On arrival, participants will have a cannula (a small tube that allows us to take blood) inserted into their arm; this will stay in the arm and allow investigators to take regular blood samples throughout the day. Blood samples and blood pressure will be taken at 30, 60, 120 and 180 minutes after breakfast. Following this, a lunch meal will be provided and investigators will continue taking blood samples and blood pressure at 30, 60, 120 and 180 minutes after this lunch meal. In total, 10 blood samples will be taken over the 7 ½ hour testing period. There will also be a cognitive test in the morning and afternoon.
15997423|NCT02909894|Other|Light arm ergometry breaks|Condition B is the 'light activity breaks' condition. Participants will go through exactly the same process as condition A but will also be asked to do 5 minute bouts of light intensity arm ergometry on a desktop arm ergometer every 30 minutes following breakfast and lunch. In total they will do 12 five minute arm ergometry breaks throughout the 7 ½ hour test period (60 minutes of arm ergometry in total). In total 10 blood samples will be taken on the day.
15997424|NCT02909881|Dietary Supplement|Use of PhytoSpherix at 0 g/min|PhytoSpherix (Sweet-corn derived sugar) will be fed at 0 g/min during a 150 min cycling exercise
15997425|NCT02909881|Dietary Supplement|Use of PhytoSpherix at 1 g/min|PhytoSpherix (Sweet-corn derived sugar) will be fed at 1 g/min during a 150 min cycling exercise
15997426|NCT02909881|Dietary Supplement|Use of PhytoSpherix at 1.5 g/min|PhytoSpherix (Sweet-corn derived sugar) will be fed at 1.5 g/min during a 150 min cycling exercise
15997427|NCT02909881|Dietary Supplement|Use of PhytoSpherix at 2 g/min|PhytoSpherix (Sweet-corn derived sugar) will be fed at 2 g/min during a 150 min cycling exercise
15997428|NCT02909881|Behavioral|Cycling exercise|Male endurance athletes will complete a cycling exercise for 150 min at 50% of their respective maximum wattage
15997429|NCT02909868|Device|BackBeat-PHC|A conductance catheter will be used to obtain PV loops prior to a Moderato pacemaker implant procedure.
15997430|NCT02909855|Other|No intervention|Participants in this study will not receive any interventions as part of the study.
15997431|NCT02909842|Dietary Supplement|Drinking fermented milk|Drinking fermented milk containing Lactobacillus paracasei (IMULUS)
15997432|NCT02909842|Dietary Supplement|placebo|Acidified placebo milk with similar physical characteristics to the yoghurt drink
15997433|NCT02909842|Biological|Seasonal Influenza Vaccine (H1N1, H3N2, PhuB)|Intramuscular injection of a single shot of influenza vaccine
15997434|NCT02909829|Device|Closed Loop Delivery|Insulin will be delivered by subcutaneous insulin infusion pump. Infusion rates will be changed manually every 10 minutes based on the computer generated recommendation infusion rates, calculated from the glucose levels measured by a real time sensor. The computer generated recommendations are based on a predictive algorithm.
15997435|NCT02909829|Device|Closed Loop Delivery with Meal Detection Module|Closed Loop Delivery with Meal Detection Module Insulin will be delivered by subcutaneous insulin infusion pump. Infusion rates will be changed manually every 10 minutes based on the computer generated recommendation infusion rates, calculated from the glucose levels measured by a real time sensor. The computer generated recommendations are based on a predictive algorithm with an overlying meal detection module which detects missed meals and will increase insulin infusion rates based on a predictive meal detection algorithm
15997436|NCT02909829|Device|Conventional Pump Therapy|Insulin will be delivered by subcutaneous insulin infusion pump with participants usual infusion rate
15997437|NCT02909803|Other|Lentil Variety|Participants will consume 8 varieties of lentils that are cooked by boiling
15997438|NCT02909803|Other|White Bread|Participants will consume white bread on at least two different test days
15997439|NCT02909790|Device|Curve Low Level Laser Therapy|"Subjects assigned to the treatment group will be treated with 4 multi-paddle low-level diode laser consisting of 8 independent diode laser heads per treatment paddle, each emitting 630-680nm (red) laser light with each diode generating 40mW output (CURVE Laser - manufactured by YOLO Medical Inc.)."
15997440|NCT02909777|Drug|CUDC-907|
15997441|NCT02909764|Other|Low Sodium Group|Breakfast Cereal
15997442|NCT02909751|Drug|Epirubicin 90 mg/m2 iv|Max. 3 months
15997443|NCT02909751|Drug|Cyclophosphamide 600 mg/m2 iv|Max. 3 months
15997444|NCT02909751|Drug|Docetaxel 100 mg/m2 iv OR paclitaxel 80 mg/m2 iv|Max. 3 months
15997445|NCT02909751|Drug|Trastuzumab 8 mg/kg iv saturation, then 6 mg/kg iv (HER2 positive patients only)|Max. 3 months.
15997446|NCT02909751|Drug|Pertuzumab 840 mg iv saturation, then 420 mg iv (selected HER2 positive patients only)|Max. 3 months
15997447|NCT02909751|Dietary Supplement|Tocotrienol 300 mg x 3 daily|Max. 6 months
15997448|NCT02909738|Other|Volunteer to pedal a bicycle|
15997449|NCT02909725|Other|Limit accumulation of sedentary time|"Participants in this group receive a Fitbit Alta activity monitor, worn on the wrist for the entire intervention. The Alta is a fitness tracker designed to help individuals track their sedentary and physical activity behaviors when paired with an external device (e.g. iPhone, computer). The Sensewear armband and ActivPAL are not worn as part of the intervention; they are assessment tools used at the beginning and end of the study.
~Each participant will have a Fitbit account set up with a Blossom Project username code to ensure privacy of the participant's identity. Participants will be asked to achieve a goal of 250 steps/hour. Using the reminder to move function, if a participant has not reached the hourly goal at 50 minutes, the Alta will vibrate, cueing the participant to walk."
15997450|NCT02909725|Other|Walk|"Participants in this group receive a Fitbit Charge activity monitor. There is no reminder to move function on this band. The Charge, worn on the wrist for the entire intervention is a fitness tracker designed to help individuals track their physical activity when paired with an external device. The Sensewear armband and ActivPAL are not worn as part of the intervention; they are assessment tools used at the beginning and end of the study.
~Each participant will have a Fitbit account set up with a Blossom Project username code to ensure privacy of the participant's identity. Participants will be asked to meet current pregnancy physical activity recommendations; walking 30 minutes, most days of the week (150 minutes/week). Participants can use the app to view their active minutes."
15997451|NCT02909725|Other|Normal daily routine; Usual Care|Participants in this group will not be provided with a Fitbit Charge activity monitor, as participants will be asked to simply continue on with their normal daily routine. The Sensewear armband and ActivPAL are not worn as part of the intervention; they are assessment tools used at the beginning and end of the study.
15997452|NCT02909712|Drug|sulfadoxine-pyrimethamine (SP)|"Women in Groups 1 and 2 will be provided the following SP regimen as directly observed therapy:
~3 tablets total of 500 mg sulphadoxine and 25 mg pyrimethamine; 1 day of dosing."
15997453|NCT02909712|Drug|dihydroartemisinin-piperaquine (DHA-PQP)|Women in Groups 3 and 4 will be provided the following DHA-PQP regimen as directly observed therapy 3 tablets of 40 mg dihydroartemisinin and 320 mg piperaquine daily; 9 tablets total; 3 days of dosing.
15997454|NCT02909699|Other|Observation|In this trial, cardiovascular function will be measured without drug administration. The drug will be administered within the main trial.
15997465|NCT02909673|Behavioral|Fourth R|Fourth R integrates the promotion of healthy relationship skills and prevention of teen dating violence into existing school curricula so that students receive regular course credit in health. Fourth R is grounded in social cognitive theory in which youth learn to formulate and choose behavior strategies, which translate into knowledge and practice in decision-making, non-aggressive conflict resolution skills, and self-efficacy..
15997466|NCT02909660|Other|Cognitive-behavioural therapy|Empirically-supported psychological intervention for various mental health concerns including obsessive-compulsive disorder (OCD). Includes components to foster cognitive (i.e., thinking) and behavioural changes.
15997467|NCT02909647|Procedure|Preoperative planning|preoperative planning using 3D digital planning software or conventional template
15997468|NCT02909647|Procedure|Osteosynthesis|osteosynthesis using volar locking plate
15997469|NCT02909621|Dietary Supplement|FLEXOFYTOL®|The product FLEXOFYTOL® is bio-optimized curcumin.
15997470|NCT02909621|Other|PLACEBO|
15997471|NCT02909608|Other|No interventions / observations only|This is an observational study only
15997472|NCT02909595|Device|Balloon catheter|Balloon stone extraction was carried out with a balloon catheter [Extractor Pro RX [M00547000, M00547010, or M00547020]; Boston Scientific,Shang hai,China). The Extractor Pro has multiple sizes (9-12, 12-15, and 15-18mm), the choice being made on the basis of the CBD diameter. It has a contrast-injection hole above the balloon for the performance of balloon occlusion cholangiography (BOC).
15997473|NCT02909595|Device|Basket catheter|Basket stone extraction was performed with a basket catheter (Flower Basket V [FG-V435P or FG-V425PR]; Olympus Corp., Shang hai,China).
15997474|NCT02909582|Procedure|Cohen Incision|This is a straight transverse incision through the skin, 3 cm below the level of the anterior superior iliac spines (higher than the Pfannenstiel incision). Should a pannus exist, the pannus should be left in the physiologic location (not retracted) to allow placement of the incision.
15997475|NCT02909569|Drug|INCB039110|All subjects will receive 400 mg PO QD for 12 weeks. If no clinical response after four weeks, dose will be increased to 600 mg PO QD. Total duration of subject participation will be six study visit over 20 weeks.
15997476|NCT02909556|Device|Transcatheter aortic valve replacement|Transcatheter aortic valve replacement via transfemoral access
15997477|NCT02909543|Other|Observation and Interviwe|The research data will be conducted by using a semi structured interview of the participants in the study.
15997478|NCT02909530|Device|EUS-FNB with EZ Shot 3Plus first|Both needles (EZ Shot 3Plus 19G and EZ Shot 2 19G) will be used for endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) in each patient following a predetermined random order which needle is used to pass through the tumor first.
15997479|NCT02909530|Device|EUS-FNB with EZ Shot 2 19G first|Both needles (EZ Shot 3Plus 19G and EZ Shot 2 19G) will be used for endoscopic ultrasound-guided fine needle biopsy (EUS-FNB) in each patient following a predetermined random order which needle is used to pass through the tumor first.
15997480|NCT02909517|Other|cSLO imaging|
15997481|NCT02909504|Drug|Lithium|Eligible patients will receive lithium 300 mg twice daily and titrated in 300 mg increments every 7 days as tolerated to levels > 0.6 mEq/L
15997482|NCT02909478|Drug|Aprepitant+Tropisetron|"Patients will receive the chemotherapy drugs oxaliplatin,leucovorin and 5-fluorouracil as well as the following antiemetic drugs:
~aprepitant (125 mg orally on day 1 and 80 mg orally on days 2 and 3) plus Tropisetron (5mg IV of day1)"
15997483|NCT02909478|Drug|Dexamethasone+Tropisetron|"Patients will receive the chemotherapy drugs oxaliplatin, leucovorin and 5-fluorouracil as well as the following antiemetic drugs:
~Dexamethasone (10 mg IV on day 1 and 5 mg IV days 2, 3) plus Tropisetron (5mg IV of day1)"
15997484|NCT02909465|Drug|Midazolam|Using Midazolam as a premedication for reducing ketamine-induced agitation
15997485|NCT02909465|Drug|Haloperidol|Using Haloperidol as a premedication for reducing ketamine-induced agitation
15997486|NCT02909465|Drug|placebo|distilled water
15997487|NCT02909465|Drug|Ketamine|Ketamine is routinely used for all procedural sedation in the patients.
15997488|NCT02909452|Drug|Entinostat|HDAC (histone deacetylase) inhibitor
15997489|NCT02909452|Drug|Pembrolizumab|A selective humanized monoclonal antibody (mAb)
15997490|NCT02909439|Drug|Sugammadex|Sugammadex will be given for reversal of neuromuscular blockade.
15997491|NCT02909439|Drug|Neostigmine|Neostigmine will be given for reversal of neuromuscular blockade.
15997492|NCT02909426|Device|Ultrasonography|Radiologists' hand-held bilateral breast ultrasonography for each participant for one time
15997493|NCT02909426|Device|Digital mammography|Full-field digital mammography using one of the equipments from General Electric (GE), Hologic, and Medi-future companies for each participant for one time
15997494|NCT02909413|Drug|Desﬂurane|Anesthesia maintenance: After endotracheal intubation, half of the patients will be randomized into Desﬂurane Group. The gas flow rate of Desflurane group is 2 L/min, include 50％ O2 and 4～5％ Desflurane.
15997495|NCT02909413|Drug|sevoﬂurane|Anesthesia maintenance: After endotracheal intubation, half of the patients will be randomized into Sevoﬂurane Group. The gas flow rate of Desflurane group is 2 L/min, 50％O2 and 1.7-2.0% Sevoflurane.
15997496|NCT02909400|Drug|KH176|
15997497|NCT02909400|Drug|placebo|
15997498|NCT02909387|Behavioral|Project UPLIFT|UPLIFT is an 8-week distance-delivered mindfulness-based cognitive therapy intervention.
15997499|NCT02909374|Other|Balance training|The balance-training program was developed based on well-established principles of exercise and on the knowledge that balance control relies on the interaction of several physiological systems, as well as interaction with environmental factors and the performed task. It includes exercise with dual- and multi task performance. It is progressive as the exercises can be performed at different levels (basic, moderate, and advanced), making it progressively challenging for each individual throughout the whole program. The training is conducted as an individually tailored group program.
15997500|NCT02909361|Drug|Fulvestrant|500 mg on days 0, 14, and 28, and every 28 days thereafter
15997501|NCT02909348|Drug|Pembrolizumab|3mg/kg, intravenous and on day1 of each 21 day cycle until progression or unacceptable toxicity develops.
15997575|NCT02908763|Drug|peginterferon alfa|peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week, for at most 96 weeks.
15998172|NCT02903849|Behavioral|Control Reminders|Receive standard reminders at three points during the challenge
15997502|NCT02909335|Drug|Tacrolimus|"Tacrolimus is administered at an initial dose of 0.040 mg / kg twice a day on Day 5.
~The doses are then adjusted to maintain trough levels :
~between 6 and 10 ng / ml during the first 2 months,
~between 5 and 8 ng / ml from the start of the end M3 and M6,
~and between 4 and 6 ng / ml between the beginning and the end of M7 M12."
15997503|NCT02909335|Drug|Everolimus|"Everolimus is administered at an initial dose of 1.5 mg twice a day on Day 5.
~The doses are then adjusted to maintain trough levels:
~between 6 and 10 ng / ml during the first 2 months,
~between 5-8 ng / ml from the start of the end M3 and M6,
~and between 4 and 6 ng / ml between the beginning and the end of M7 M12."
15997504|NCT02909335|Drug|Mycophenolate mofetil|mycophenolate mofetil is administered similarly in the two groups at the dose of 1.5 g for the first two months and then 1 g twice a day. The doses may be adjusted according to the tolerance of the product.
15997505|NCT02909335|Drug|Prednisolone, Prednisone or Methylprednisolone|Corticosteroid is similarly administered in both groups between baseline and the end of M6 and adjusted in case of acute rejection
15997506|NCT02909322|Procedure|Bupivacaine and Hydromorphone|Patients receive bupivacaine and hydromorphone infusion and bolus doses during surgery and 3 days after surgery.
15997507|NCT02909322|Procedure|Ropivacaine and Hydromorphone|Patients receive ropivacaine and hydromorphone infusion and bolus doses during surgery and 3 days after surgery.
15997508|NCT02909309|Device|JAWAC system + Capnoline + Spo2|measure mandibular mouvements + etCO2 + pulse oxymetry, respectively
15997509|NCT02909296|Procedure|Endoscopic drainage|
15997510|NCT02909283|Procedure|Physical exams and blood analyzes|Blood samples collection (for DNA, plasma and cells analyzes) ; Hemorheologic analyzes ; ASL sequence on MRI ; Near Infra Red Spectroscopy (NIRS) and associated cardiofrequency analyze.
15997511|NCT02909270|Device|Mediclore|to apply mediclore fully around thyroid gland
15997512|NCT02909257|Drug|Same Bupivacaine Concentration|patient is exposed to the same concentration than previously successful one
15997513|NCT02909257|Drug|Lower Bupivacaine Concentration|patient is exposed to a lower concentration than previously successful one
15997514|NCT02909244|Biological|Biological sampling|Biological sampling
15997515|NCT02909218|Other|Early Access to ART for All|All HIV-positive individuals will be initiated on Swaziland's recommended first-line ART regimen, unless contraindicated when recommended alternate regimens will be used per national guidelines.
15997516|NCT02909205|Other|sensitization / educational program|the intervention program was built based on the results of the pre-intervention phase survey, about the knowledge of caregivers and parents of children with gastrostomy about gastrostomy management. It consists in booklets for caregivers and parents of children. This booklet is the support of a specific training of carers and parents of children who have recently benefitted from a gastrostomy
15997517|NCT02909205|Other|training / sensitization program|diffusion of gastrostomy in-hospital care protocols, and booklets for families. These tools have been prepared by a pilot group of professional of the investigating centers.
15997518|NCT02909192|Device|Light Therapy Device|
15997519|NCT02909179|Other|mCARE-II|mCARE-II is a package of interventions that provides guided client enumeration and follow-up support to community health workers, automated workflow scheduling, risk assessment, client prioritization and stratification and client-based demand generation messaging. These features are incorporated into a platform called OpenSRP, which integrates text message reminders, scheduling, and form submissions on the server side, and displays schedules and client lists on a tablet-based application for community health workers.
15997520|NCT02909166|Drug|aliskiren|
15997521|NCT02909153|Drug|Triferic|Triferic is an iron salt that is approved by the FDA for the maintenance of hemoglobin in patients with end stage kidney disease on hemodialysis. It is experimental in this study because it has not yet been approved for patients on chronic peritoneal dialysis.
15997522|NCT02909140|Drug|Topical phenylephrine 2.5%|
15997523|NCT02909140|Drug|Topical cyclopentolate 1%|
15997524|NCT02909140|Drug|Intracameral Lidocaine 1%|
15997525|NCT02909140|Drug|Intracameral 0.2- 0.3ml of epinephrine 1:10,000|
15997526|NCT02909127|Other|SWALLOWING EVALUATION|Swallowing function of the CP patients will be imaged and recorded with Videofluoroscopic Swallowing Study (VFSS). The oral cavity, pharynx, larynx and just below the upper esophageal sphincter are visible. 3 trials of 3 ml of liquids will be used and the worst score will be considered for calculation. The Penetration-Aspiration Scale (PAS) will be used to assess dysphagia severity. The PAS is an ordinal scale consisting of eight scores. Scores are determined primarily by the depth to which material passes in the airway and by whether or not material entering the airway is expelled.
15997527|NCT02909127|Other|The Functional Independence Measure|The Functional Independence Measure for Children (Wee-FIM) will be used to assess the functional independence level of the CP children. The Wee-FIM is developed to emphasize habilitative and developmental aspects of children with special health care needs, genetic disorders, developmental disabilities, and acquired disabilities.
15997528|NCT02909127|Other|The PEDI-EAT-10|The PEDI-EAT-10 will also be administered.
15997529|NCT02909114|Radiation|Stereotactic body radiotherapy|"All patients will undergo planning CT simulation. 4-dimensional CT will be used for tumors in the lungs or liver. For all lesions, the gross tumor volume (GTV) will be defined as the visible tumor on CT and/or MRI imaging +/- PET. A Planning Target Volume (PTV) margin of 3-5 mm will be added depending on site of disease, immobilization, and institutional set-up accuracy.
~The prescirbe dosage was as following: Lung lesion DT50-60 Gy/5 fractions; liver 50-60Gy/5-8 fractions; brain DT 40Gy/4-5fractions. All will be treated with SBRT"
15997530|NCT02909101|Device|Active Cognitive Training (ACT)|Cognitive training games
15997531|NCT02909101|Device|Control Training (CON)|Cognitive training games
15997532|NCT02909088|Drug|Ecopipam 50mg|
15997533|NCT02909088|Drug|Ecopipam 100mg|
15997534|NCT02909075|Device|PET/CT scans|
15997535|NCT02909075|Device|MRI|
15997536|NCT02909062|Device|Electronic Activity Monitoring (EAM)|All registered patients will receive a wearable EAM device that will measure their physical activity. Patients will wear this device around their wrist for the designated period of assessment. The EAM device has the potential to measure active minutes, number of steps, distance walked and number of floors climbed. For the purpose of this study the EAM data captured will focus on daily step count.
15997659|NCT02908100|Drug|GDC-0853|Participants received GDC-0853 at dosages of 150 or 200mg as per the dosing schedules described above.
15997537|NCT02909062|Behavioral|Daily Questionnaire|Participants will be asked to complete this self-administered, paper-based questionnaire each day that they are expected to wear the EAM device. The questionnaire was designed specifically for the purpose of this study. It consists of 5 items that ask about the patient's perceived level of physical activity and fatigue in each 24 hour period that they have worn the EAM device. The daily questionnaires will be optional; however each participant will be encouraged to complete them.
15997538|NCT02909049|Drug|MIDAZOLAM|Intravenous bolus anesthesia 5 minutes previous to saturation prostate biopsy.
15997539|NCT02909049|Drug|MEPIVACAÍNE|Local periprostatic anesthesia infiltration, previous to saturation prostate biopsy.
15997540|NCT02909049|Drug|FENTANILE|Intravenous bolus anesthesia 3 minutes previous to saturation prostate biopsy.
15997541|NCT02909049|Drug|KETAMINE|Intravenous bolus anesthesia 1 minute previous to saturation prostate biopsy.
15997542|NCT02909036|Device|Melphalan|
15997543|NCT02909036|Drug|Pegfilgrastim|
15997544|NCT02909036|Procedure|Autologous Hematopoietic Progenitor Cell Transplant|
15997545|NCT02909023|Biological|blood samples are performed to measure active T cellular immune response during a routine visit|"During the visit 1 (V1), after signing the informed consent, 40 mL blood sampling are carried out and analyzed with the test ELISPOT to check if the patient shows a T immune response against HBV.
~The visit 2 will be performed 4-8 weeks (depending on the availability of the patient) following V1 visit, in case the patient shows an immune response against HBV positive T following the sample taken at V1. 150 ml blood sampling are carried out at this visit."
15997546|NCT02909010|Device|BIS™ Brain Monitoring System|The intervention group using BIS monitoring to adjust sedation in order to maintain values between 50-60
15997547|NCT02909010|Other|RASS|control group in which sedation was adjusted with the exclusive use of Richmond Agitation-Sedation Scale (RASS) to maintain RASS -2
15997548|NCT02908997|Other|MindMate|A dementia-specific mobile reminding application
15997549|NCT02908984|Behavioral|Specific neck rehabilitation|Guided craniocervical, axioscapular and proprioceptive training that includes education, postural exercises, as well as training of cervical and shoulder muscles, and vestibular rehabilitation, included oculomotor function if indicated, and general exercises
15997550|NCT02908984|Other|Standard primary health care|The treatment may include pharmacological medication, chiropractic and physiotherapy or no active treatment
15997551|NCT02908971|Behavioral|soy based formula at infancy|The intervention is only past history of soy consumption
15997552|NCT02908958|Biological|PEG-somatropin|High dose group: PEG Somatropin 0.2 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.
15997553|NCT02908958|Biological|PEG-somatropin|Low dose group: PEG Somatropin 0.14 mg/kg/w, subcutaneous use, inject once a week, the duration is for 26 weeks.
15997554|NCT02908945|Drug|Ketamine|Bolus dose before induction of anesthesia and infusion during maintenance of anesthesia.
15997555|NCT02908945|Device|NeuroSENSE monitor|NeuroSENSE monitors the brain using electroencephalography (EEG) and produces an index called the WAVCNS. WAVCNS is a measure of depth of hypnosis (DoH).
15997556|NCT02908932|Dietary Supplement|Phospholipid-bound omega-3 supplement|The dietary supplement is produced by Aker BioMarine. These krill oil capsules received a GRAS status approval from the U.S. Food and Drug Administration (FDA) in 2010. Aker BioMarine has a new pending application (2015) with the U.S. FDA for GRAS status for its new product on which this study capsule is based. Aker BioMarine markets a number of different krill-based omega-3 supplement products in the U.S. The US Food and Drug Administration (FDA) has determined that an Investigator New Drug (IND) Application is not required for this study. This phospholipid-bound omega-3 dietary supplement is provided in capsule form.
15997557|NCT02908932|Dietary Supplement|Placebo supplement|Placebo capsules that are identical in size and color to the experimental but contain an equal amount of macadamia nut oil.
15997558|NCT02908919|Procedure|Colonoscopy|The quality of bowel preparation, which is checked during colonoscopy
15997559|NCT02908906|Drug|JNJ-63723283|JNJ-63723283 will be administered by IV infusion or SC injection or infusion.
15997560|NCT02908893|Behavioral|In-app and push notification mobile messages|Short messages (100-250 characters) are to be delivered to a mobile app both by push notification (i.e., appearing on the phone dashboard like a text message if the user has allowed notifications from the app) and in-app messages (visible in the news feed of the wellness program app when the app is opened). Messages contain a short title (30 characters) and 2-3 lines of text in the body (30 characters each).
15997561|NCT02908880|Device|MANTA vascular closure device|The appropriate size of MANTA closure device will be selected and used for the closure of femoral arterial access sites following the use of 10-14F devices or sheaths or the use of 15-18F devices or sheaths.
15997562|NCT02908867|Other|Therapeutic Strategies|Using questionnaires (Erectile Function of International Index and American Impairment Scale) and search in public markets using semi structured form
15997563|NCT02908854|Other|Adding spices and herbs to school lunch vegetables|Direct measurement of school lunch vegetable intake among students both before and after spices and herbs are added.
15997564|NCT02908841|Device|Surgicel Snow|
15997565|NCT02908841|Other|Standard of Care|
15997566|NCT02908828|Dietary Supplement|Calanus oil|
15997567|NCT02908828|Dietary Supplement|placebo dietary oil|
15997568|NCT02908815|Device|rTMS active treatment|Repetitive Transcranial Magnetic Stimulation uses magnetic pulses to active neurons.
15997569|NCT02908815|Device|rTMS sham treatment|A fake treatment designed to mimic the sensations of rTMS
15997570|NCT02908802|Dietary Supplement|Probiotic|Probiotic
15997571|NCT02908802|Dietary Supplement|Placebo|Probiotics capsules without the active ingredient
15997572|NCT02908789|Radiation|Antimicrobial photodynamic therapy (aPDT)|Antimicrobial photodynamic therapy (aPDT) is an effective low potency laser that involves the activation of a photosensitizer( 0.01% methylene blue ) by a visible light source that creates chemical reactions, producing cytotoxic reactive oxygen species and causing oxidative stress and inactivation of pathogenic microorganisms.
15997573|NCT02908776|Dietary Supplement|Probiotic|Sachets with Streptococcus thermophilus DSM 32245: 70 billion, bifidobacteria (Bifidobacterium lactis DSM 32246, Bifidobacterium lactis DSM 32247) 40 billion, lactobacilli (Lactobacillus acidophilus DSM 32241, Lactobacillus helveticus DSM 29575, Lactobacillus paracasei DSM 32243, Lactobacillus plantarum DSM 32244, Lactobacillus brevis DSM 27961): 90 billion.
15997576|NCT02908750|Drug|Fexofenadine tablet dosing|Fexofenadine (P-gp substrate) 120mg taken once daily on Days 1 in Treatment Period 1 and Day 1 and Day 39 in Treatment Period 2
15997577|NCT02908750|Drug|Osimertininb tablet dosing|Osimertininb 80 mg taken once daily on Day 1 and Days 4 to 41 in Treatment Period 2
15997578|NCT02908737|Device|Bass and Treble|Bass and Treble controls are clinician enabled and provide the recipient with access to the adjustment of low and high frequency sound balance, known as Bass and Treble respectively
15997579|NCT02908711|Drug|0.5% ropivacaine|Adductor canal block (ACB) performed as part of their analgesic regimen for primary total knee arthroplasty achieved with 20 cc of 0.5% ropivacaine under constant ultrasound visualization.
15997580|NCT02908698|Drug|Prednisone|"Total treatment duration: 15 days
~Doses are as follows:
~5 days daily treatment with 0.75 mg/kg of body weight 5 days daily treatment with 0.5 mg/kg of body weight 5 days daily treatment with 0.25 mg/kg of body weight"
15997581|NCT02908698|Drug|Placebo Control|Total treatment duration: 15 days. Doses will appear identical to prednisone arm.
15997582|NCT02908685|Drug|Placebo|Placebo will be administered orally (via mouth) or through a feeding tube (naso-gastric or gastrostomy tube).
15997583|NCT02908685|Drug|Risdiplam|Risdiplam will be administered orally (via mouth) or through a feeding tube (naso-gastric or gastrostomy tube).
15997584|NCT02908672|Drug|Atezolizumab|Will be administered as per the schedule described in individual arm.
15997585|NCT02908672|Drug|Atezolizumab Placebo|Will be administered as per the schedule described in individual arm.
15997586|NCT02908672|Drug|Cobimetinib|Will be administered as per the schedule described in individual arm.
15997587|NCT02908672|Drug|Vemurafenib|Will be administered as per the schedule described in individual arm.
15997588|NCT02908672|Drug|Vemurafenib Placebo|Will be administered as per the schedule described in individual arm.
15997589|NCT02908646|Procedure|microcoil localization|CT-guided localization by placing a microcoil into the lung parenchyma
15997590|NCT02908646|Procedure|hookwire localization|CT-guided localization by placing a hookwire into the lung parenchyma
15997591|NCT02908633|Procedure|canaloplasty and phacoemulsification|
15997592|NCT02908620|Combination Product|One spray CTY-5339-A|Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredients: 14.0% Benzocaine (USP = 28 mg) and 2.0% Tetracaine Hydrochloride (USP = 4 mg). Administered in a single anesthetic spray.
15997593|NCT02908620|Drug|One spray CTY-5339-CB|Metered spray bottle with ≈200 uL total spray volume. Contains the active ingredient: 14.0% Benzocaine (USP = 28 mg). Administered in a single anesthetic spray.
15997594|NCT02908620|Combination Product|Two sprays CTY-5339-A|Metered spray bottle with ≈400 uL total spray volume. Contains the active ingredients: 14.0% Benzocaine (USP = 56 mg total) and 2.0% Tetracaine Hydrochloride (USP = 8 mg total). Administered in two anesthetic sprays.
15997595|NCT02908620|Drug|One spray CTY-5339-CB in combination with one spray CTY-5339-P (vehicle control: placebo)|A single spray of CTY-5339-CB in a metered spray bottle with ≈200 uL total spray volume, containing the active ingredient: 14.0% Benzocaine (USP = 28 mg). This was administered in combination with a single spray of CTY-5339-P (acting as vehicle control placebo with no active ingredient) in a metered spray bottle with ≈200 uL total spray volume. This combination was used to maintain double-blind conditions. The vehicle control was sprayed outside the circumscribed area to avoid dilution of active drug.
15997596|NCT02908607|Device|Thermal imaging|Examination of the cervix by thermal imaging camera
15997597|NCT02908594|Device|Medical Exercise Peddler 3000, Medi-Bike, Taiwan|"A horizontal electromagnetic cycle ergometer (Medical Exercise Peddler 3000, Medi-Bike, Taiwan) was used for the exercise program. The cycling equipment includes the resistance of 6 Levels, from Level 1 the lightest to Level 6 the heaviest. Other indicators examined are RPM (rotary per minute), DICT (The distance for this exercise), TIME (The time of exercise). This is the simplest way to use this Motion Exercise Machine. Press the ST / SP (Start/ Stop) button to start an exercise program for 30 minutes."
15997598|NCT02908581|Drug|Placebo|Administered orally once daily
15997599|NCT02908581|Drug|Iron 150 mg and Folic acid 0.5 mg|Iron will be administered with folic acid orally
15997600|NCT02908568|Device|Spring device|Brisk dilatation of fhe mouth.
15997601|NCT02908568|Device|Mandible stimulator|Stimulation of fhe mouth.
15997602|NCT02908555|Other|No intervention|This is a descriptive study with no intervention
15997603|NCT02908542|Genetic|genetic analysis with massively parallel sequencing|
15997604|NCT02908529|Drug|Combination product of Atomoxetine and Oxybutynin|Combination product of Atomoxetine 80 mg and Oxybutynin 5 mg 2 hours before sleep
15997605|NCT02908529|Drug|Placebo, 2 tablets|Placebo 2 tablets 2 hours before sleep
15997606|NCT02908516|Drug|Tranexamic Acid|2 doses of 1.95 g TXA orally, once in the ED and another dose pre-operatively.
15997607|NCT02908516|Drug|Placebo|2 doses of 1.95 g cellulose orally, once in the ED and another dose pre-operatively.
15997608|NCT02908503|Other|Placebo Film|placebo vaginal films
15997609|NCT02908490|Drug|Sildenafil|Sildenafil 50 mg once daily
15997610|NCT02908490|Other|Placebo|Placebo once daily with same size, shape, color, and texture as Sildenafil 50 mg pill
15997611|NCT02908477|Radiation|Adjuvant Radiation Therapy|60 Gy / 2 Gy fractions (standard arm) 30 - 36 Gy / 1.5 - 1.8 Gy b.i.d. fractions (experimental arm)
15997612|NCT02908477|Drug|Docetaxel|15 mg/m2. Experimental arm only.
15997613|NCT02908477|Drug|Cisplatin|40 mg/m2. Standard arm only.
15997614|NCT02908464|Device|Lumosity|A neurocognitive training program designed to enhance cognitive abilities
15997615|NCT02908451|Biological|AbGn-107|Antibody Drug Conjugate
15997616|NCT02908438|Drug|Gonadotrophin releasing hormone agonist(GnRHa)|GnRHa group receive three injections of GnRHa(Decapeptyl) ,0.1 mg s.c. on the day of ET, and D3 and D6 after ET in addition to routine LPS.
15997617|NCT02908425|Other|Statin user|Subjects will be studied on 2 occasions with both being identical. One will be after 7 days or more of cholesterol lowering statin administration and the other occasion will be after at least 4 weeks of cholesterol lowering statin discontinuation. All study visits include (but are not limited to) blood draws, urine collection, and stable isotope infusions.
15997660|NCT02908100|Drug|Placebo|Participants received matching placebo to GDC-0853 at dosages of 150 and 200mg as per the dosing schedules described above.
15998211|NCT02903498|Drug|UFT|UFT 360mg/m2 qd po d1-14, q3w
15997618|NCT02908412|Drug|Digital nerve block with bupivacaine|The aim of the study, the way it will be conducted, and the complications and possible risks are explained to them. written informed consent is obtained from them. Then, after induction of anaesthesia, an arterial line will be inserted in order to monitor blood pressure and to take blood samples. During the surgery, two rainbow adult ReSposable sensors will be attached to the third or fourth fingers of both hands, and each of sensors will be attached to a monitor. Patients will be randomly assigned to two groups: group A will receive DNB in left hand and group B will receive DNB in right hand. DNB will be performed by injecting 2 ml of 0.25% bupivacaine at the base of medial and lateral sides of the finger attached to the sensor (1 ml on each side of the base).
15997619|NCT02908399|Device|FLIR ONE|
15997620|NCT02908373|Other|Implementation of the coaching model|20 hours methodological help for each nursing home and an implementation kit
15997621|NCT02908360|Genetic|double positive T cells (CD4 + / CD8 +) to the specific peripheral blood of F prauznitzii analyse|
15997622|NCT02908347|Drug|MP1032|hard gelatine capsules containing 50 mg MP1032 as active ingredient
15997623|NCT02908347|Drug|Placebo|hard gelatine capsules without active ingredient
15997624|NCT02908334|Drug|Sertraline|400 mg/day sertraline
15997625|NCT02908321|Behavioral|CBT|The group based manualised CBT intervention consists of The Cool Kids Anxiety Program: Autism Spectrum Disorder Adaptation (Cool Kids ASD).
15997626|NCT02908308|Procedure|Targeted temperature management to 33°C|Rapid cooling to below 33°C, followed by temperature control at 33°C for up to 28h.
15997627|NCT02908308|Procedure|Standard care with early treatment of fever|Normothermia and standard care - use of a device for temperature control if temperature is greater than or equal to 37.8°C
15997628|NCT02908295|Drug|Rectal Misoprostol|Rectal Misoprostol Misoprostol 400 mcg (200 mcg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation
15997629|NCT02908295|Drug|Placebo|Rectal Vitamin B6 Vitamin B6 (Placebo) 200 mg (100 mg/tablet) or 2 tablets were given rectally at 15 - 30 minutes prior the operation
15997630|NCT02908282|Device|REMOGEN OMEGA|Lubricant eye drops: preservative-free, hypotonic microemulsion of polyunsaturated fatty acids and hydrating polymers provided in single-dose containers of 0.25 ml.
15997631|NCT02908282|Device|Povidone|Artificial tears: preservative-free eye drops containing 2% povidone.
15997632|NCT02908269|Biological|Fluzone Quadrivalent vaccine, 2016-2017 formulation, No Preservative|0.5 mL, Intramuscular
15997633|NCT02908269|Biological|Fluzone Quadrivalent vaccine, 2016-2017 formulation, No Preservative|0.5 mL, Intramuscular
15997634|NCT02908269|Biological|Fluzone High-Dose, vaccine, 2016-2017 formulation|0.5 mL, Intramuscular
15997635|NCT02908256|Drug|Geloplasma (PVI)|In the PVI group, a filling solution (geloplasma) will be given as a bolus of 250 ml administered in 10 minutes if the PVI>15% during more than 5 minutes. The bolus will be repeated if the PVI remains over 15%.
15997636|NCT02908256|Drug|Geloplasma (delta PP)|In the delta PP group, a filling solution (geloplasma) will be given as a bolus of 250 ml administered in 10 minutes if the delta PP> 13% during more than 5 minutes. The bolus will be repeated if the delta PP remains over 13%.
15997637|NCT02908243|Other|collection of baseline data|collection of baseline data including ages, types, severity, inhibitors and comorbidities
15997638|NCT02908230|Behavioral|Enhanced Care|8-week (nutrition, physical activity, and mental health) summer curriculum/program
15997639|NCT02908230|Behavioral|Standard Care|8-week (nutrition and physical activity) summer curriculum/program
15997640|NCT02908230|Behavioral|Active Control|8-week (non-nutrition, physical activity or mental health) summer curriculum/program
15997641|NCT02908217|Drug|Tocilizumab|6 Intravenous infusions of tocilizumab in a dosage of 8 mg/kg (or 4 mg/kg depending on biological results as mentioned by the SPC of Tocilizumab for the rheumatoid arthritis) every 4 weeks.
15997642|NCT02908217|Drug|Placebo|6 Intravenous infusions of placebo every 4 weeks.
15997643|NCT02908191|Drug|ABI-H0731|
15997644|NCT02908191|Drug|Placebo for ABI-H0731|
15997645|NCT02908191|Drug|Entecavir|Used to treat adults with chronic hepatitis B virus
15997646|NCT02908191|Drug|Tenofovir disoproxil fumarate|Used to treat adults with chronic hepatitis B virus
15997647|NCT02908191|Drug|Pegasys|Used to treat adults with chronic hepatitis B virus who show signs of liver damage
15997648|NCT02908191|Drug|Nucleos(t)ide|Used to treat adults with chronic hepatitis B virus
15997649|NCT02908178|Procedure|Sentinel lymph node biopsy (SLNB)|Intervention is defined as that the DCIS patient has undergone SLNB. Patients in each cohort (group) include those who underwent SLNB (intervention) and those who did not (control).
15997650|NCT02908165|Drug|conventional TACE in combination with sorafenib, administered on a continuous schedule|Patients assigned to Group A will begin sorafenib on a continuous schedule starting at 400mg BID from Cycle 1 Day 1, one week prior to cTACE treatment on Cycle 1 Day 8. After week 6, cTACE will be provided on demand (as needed, up to 4 treatments total in the first 4 cycles) at week 2 in subsequent cycles, and sorafenib will continue to be administered. Patients will be allowed to undergo dose adjustments of sorafenib as long as it remains above the ¼ dose (400mg QOD).
15997651|NCT02908165|Drug|conventional TACE in combination with sorafenib, administered on a sequential schedule|Patients assigned to Group B will undergo cTACE up to 4 treatments within the first 4 cycles as needed prior to starting sorafenib. After it is determined that no further TACE treatment is necessary (via imaging and clinical assessment on follow-up), administration of sorafenib will begin on Day 1 of the following cycle. Dosing will begin at 400mg BID and maintained continuously provided no unmanageable toxicities develop, with follow-up assessments performed on week 6 of every 1-2 cycles as needed. Patients in Group B will also be allowed to undergo dose adjustments of sorafenib as long as it remains above the ¼ dose (400mg QOD).
15997652|NCT02908152|Dietary Supplement|curcumin|"1500 mg
~1 capsule / day for 12 weeks"
15997653|NCT02908152|Dietary Supplement|placebo|"1500 mg
~1 capsule / day for 12 weeks"
15997654|NCT02908139|Device|BR-102 plus PWA|Monitoring of Arterial Stiffness and Central Aortic Pressure
15997655|NCT02908139|Device|Tanita MC780 MA S|The device measured the size of total body water (TBW), Extra Cellular Water (ECW), Intra Cellular Water (ICW), fat mass (FM%), visceral fat%, fat free mass (FFM) and basal metabolic rate, (BMR) (kcal).
15997656|NCT02908126|Drug|Oxytocin|Oxytocin drug
15997657|NCT02908113|Behavioral|collection data|
15997658|NCT02908113|Behavioral|IRM|
15997661|NCT02908087|Drug|Victoza® (liraglutide)|Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 6 months.
15997662|NCT02908087|Drug|Placebo|Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 6 months.
15997663|NCT02908074|Drug|BGS649|Capsules will be taken weekly for a maximum of 24 weeks
15997664|NCT02908061|Procedure|Surgery Radical Cystectomy|All surgeries will be performed in an open or laparoscopic fashion.
15997665|NCT02908061|Procedure|Ultrapro mesh|Surgery Mesh Placement. All surgeries will be performed in an open or laparoscopic fashion.
15997666|NCT02908048|Other|Blood samples|Blood samples collected at varying intervals over a two to three year period.
15997667|NCT02908035|Drug|Temsirolimus|After completion of revascularization therapy and any decision to place stents, patients will be qualified for final enrollment in the study and will be treated with the investigational drug or saline. Investigators will be blinded to assignment.
15997668|NCT02908035|Drug|Saline|After completion of revascularization therapy and any decision to place stents, patients will be qualified for final enrollment in the study and will be treated with the investigational drug or saline. Investigators will be blinded to assignment.
15997669|NCT02908022|Device|Electroacupuncture Analgesia|"For the MRI sessions, acupuncture needles will be inserted next to the cuff placed on the left leg and will be connected to electrodes. Low-amplitude electrical current will be activated when a button is pressed via a handheld device, controlled by the acupuncturist, in order to reduce pain, acting as an analgesic.
~Additionally, electroacupuncture-induced analgesia will be used for the treatments. During the treatment sessions the acupuncturist will insert needles in several locations aimed to reduce the patient's fibromyalgia pain. Low-amplitude electrical current will be activated by the acupuncturist using the same electroacupuncture device as in the MRI machine."
15997670|NCT02908022|Device|Hokanson Rapid Cuff Inflator|The Hokanson Rapid Cuff Inflator will be placed on the lower right leg of the subject and utilized for pain testing purposes according to the protocol. Ascending pressures will be administered using the cuff to elicit different pain intensities.
15997671|NCT02907996|Drug|Sofosbuvir|400 mg tablet administered orally once daily
15997672|NCT02907983|Drug|Stellate Ganglion Block Injection with Bupivicaine|A computer-generated stratified randomization scheme by self-reported race and by etiology of menopause (natural versus surgical menopause) will be used to assign participants to receive either a SGB with bupivacaine or a sham injection with saline. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card.
15997673|NCT02907983|Drug|Saline injection|A computer-generated stratified randomization scheme by self-reported race and by etiology of menopause (natural versus surgical menopause) will be used to assign participants to receive either a SGB with bupivacaine or a sham injection with saline. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card.
15997674|NCT02907957|Device|FLIR ONE|Thermographic assessment of the lower extremities is obtained using the FLIR ONE smartphone camera and software.
15997675|NCT02907957|Procedure|Regional Anesthesia - Caudal Nerve Block|Nerve block placement as a pain management strategy indicated for certain urological and lower extremity surgeries.
15997676|NCT02907944|Behavioral|Implementation Facilitation|"Implementation Facilitation is an evidence-based strategy tailored to the specific needs of the clinic, designed to increase uptake of evidence based treatments for tobacco, alcohol and opioid use disorders. Will include provider education and academic detailing.
~External Facilitator: Outside content expert who assists site
~Local Champion: Site stakeholder who promotes change
~Provider Education and Academic Detailing: Provision of unbiased peer education
~Stakeholder Engagement: Aligning goals of implementation and those impacted
~Tailor Program to Site: Addressing site specific needs based on Aim 1
~Performance Monitoring and Feedback: Assess implementation of screening and treatment efforts and inform site of results
~Formative Evaluation: Quant. and qual. determination of impact
~Establish a Learning Collaborative: Shared learning opportunities tailored to stakeholders
~Program Marketing: Increase attention to availability of on-site addiction treatment services"
15997677|NCT02907931|Other|Point of Care Ultrasound|
15997678|NCT02907918|Drug|Palbociclib|Palbociclib is an oral drug given at a dose of 125 mg daily on Days 1-21 of each 28-day cycle for a total of 4 cycles.
15997679|NCT02907918|Drug|Letrozole|Letrozole is an oral drug given at a dose of 2.5 mg orally once a day. It will be taken continuously (Days 1-28 of each cycle) until the day of definitive surgery.
15997680|NCT02907918|Biological|Trastuzumab|"Or FDA approved biosimilar
~Trastuzumab will be administered on a weekly basis for 16 weeks (on Days 1, 8, 15, and 22 of each 28-day cycle for a total of 4 cycles). The first dose of trastuzumab on Cycle 1 Day 1 will be a loading dose of 4 mg/kg IVPB over 90 minutes. Subsequent doses of trastuzumab will be 2 mg/kg IVPB over 30 minutes. Weekly trastuzumab will continue after the completion of Cycle 4 of palbociclib until surgery."
15997681|NCT02907918|Drug|Goserelin|Goserelin is given subcutaneously at a dose of 3.6 mg on Day 1 of each cycle. Goserelin will be continued (once every 28-days) after the completion of Cycle 4 of palbociclib if required.
15997682|NCT02907918|Procedure|Breast surgery|Standard of care
15997683|NCT02907918|Procedure|Research tumor biopsy|Baseline, cycle 1 day 15, and surgery
15997684|NCT02907918|Procedure|Research bone marrow (OPTIONAL)|Baseline and surgery
15997685|NCT02907918|Procedure|Research blood sample|Baseline, cycle 1 day 15, surgery, and yearly post-surgery for 5 years
15997686|NCT02907918|Genetic|Research blood for germline DNA|Baseline
15997687|NCT02907918|Procedure|Blood for detection of circulating tumor cells|Baseline
15997688|NCT02907905|Biological|capillary sampling|"After elution in buffer (PBS-Tween azide and thiamol) eluate 200 microliter is processed on automated techniques (Siemens Centaur XL and Diasorin) after adjustment of the figures according to ISO 15189 scope B.
~The results are qualitatively made and sent to the teams. The return of results, a proposal for appropriate care in the event of contact with virus (anti-HAV HCV HBV) through a rendering consultation results"
15997689|NCT02907892|Procedure|Glove change|Intra-operative changing of sterile surgical gloves immediately prior to abdominal closure during cesarean section
15998212|NCT02903485|Other|nurses perform presurgical assessement and surveillance during surgery|
15997690|NCT02907866|Device|Ultrasound with EBUS scope and with linear ultrasound probe|All subjects will have an ultrasound of the chest performed with the tip of the EBUS scope as well as the linear ultrasound probe, which will be used as a reference for comparison. At the end of the procedure, while the patient in the supine position, the transducer of the EBUS bronchoscope will be placed on the anterior thorax, superficial to the skin and in a sagittal direction that is perpendicular to 2 ribs. The depth of the ultrasound beam will be increased to identify the pleural sliding sign and B lines (vertical lines) when present.This will be followed by use of linear ultrasound probe to scan the chest wall for normal lung sliding, B-lines and potential pneumothorax. The patient will remain in supine position. The linear probe will be placed on anterior thorax at the level of second intercostal space. The depth of the ultrasound beam will be adjusted to identify lung sliding and B-lines.
15997691|NCT02907853|Behavioral|Contingency Management|as described above
15997692|NCT02907840|Device|Swisstom BB2|Electrical impedance tomography lung monitoring uses a dedicated belt placed around patient's thorax to detect change in impedance due to change in aeration within the thorax
15997693|NCT02907827|Other|follow up DW MRI|Whole-body diffusion-weighted magnetic resonance imaging and cfDNA analysis
15997694|NCT02907814|Device|Optical Coherence Tomography (OCT)|The OCT scan is a brief, non-contact scan of the back of the eye using infrared light. Subjects will see a light and be asked to look forwards while the scan is completed.
15997695|NCT02907814|Other|Eye Exam|This is a brief, non-contact ocular exam.
15997696|NCT02907801|Behavioral|Perception-Action Approach|Environmental set-up, gentle manual guidance, and caregiver education
15997697|NCT02907775|Device|ShefStim|Electrode arrays will be worn over the affected arm with stimulation applied over the extensor aspect of the upper arm
15997698|NCT02907775|Device|Electrodes|electrodes placed over the radial nerve in radial grove
15997699|NCT02907762|Device|Endovascular aneurysm repair EVAR|
15997700|NCT02907749|Drug|Spironolactone and carvedilol|Patients are treated with carvedilol in combination with spironolactone.
15997701|NCT02907749|Drug|Carvedilol|Patients are treated with carvedilol only.
15997702|NCT02907723|Device|Sleep Recording|the device records movements during patients' sleep
15997703|NCT02907710|Drug|Endostar|intravenous infusion
15997704|NCT02907710|Drug|DDP|
15997705|NCT02907697|Behavioral|Life Steps-Drug Use|
15997706|NCT02907697|Behavioral|General Health Education|
15997707|NCT02907684|Dietary Supplement|Almonds|Participants to consume almonds as snacks to contribute to 20% of their energy requirements daily for 4 weeks
15997708|NCT02907684|Dietary Supplement|Muffins/Crackers|"Participants to consume muffins/crackers as snacks to contribute to 20% of their energy requirements daily for 4 weeks
~NB all participants will have a run in period for 2 weeks whereby muffins are consumed, this is prior to randomisation."
15997709|NCT02907671|Procedure|carpal tunnel corticoanesthetic injection|Different Injection Sites (between the flexot tendons or around the median nerve with hydrodissection)
15997710|NCT02907658|Behavioral|PROTECT intervention group|The indicated preventive intervention PROTECT consists of a cognitive-behavioral 4-session brief-protocol (90 minutes). It targets empirically identified risk factors of Internet Use Disorder (IUD), i.e. (1) boredom and motivational problems, (2) procrastination and performance anxiety, (3) social behavior and (4) emotion regulation. It addresses both risk-reduction and strength-promotion by cognitive behavioral (CB) interventions such as (1) psychoeducation, (2) cognitive restructuring (identification and modification of dysfunctional cognition), (3) behavior modification (improving problem solving skills, training of functional behavior and reinforcement) as well as (4) improving emotion regulation (training of sensory, imaginative and mindfulness based techniques).
15997711|NCT02907645|Behavioral|Local educational information|Adult patients in this arm receive educational information regarding influenza vaccination based on local data
15997712|NCT02907645|Behavioral|National educational information|Adult patients in this arm receive educational information regarding influenza vaccination based on national data
15997713|NCT02907632|Drug|Metoclopramide|"Metoclopramide Solution 4 mg / ml; 30 ml canister (1 drop equals 0.2 mg). Dose: 0.2 mg / kg / dose (1 drop per kg) every 8 hours orally 15 minutes before lactation.
~Duration: Until the child completes 40 weeks of post menstrual age."
15997714|NCT02907632|Drug|Placebo|Oral solution: 1 drop per kg of placebo 15 minutes before lactation with identical presentation appearance, taste and color than Metoclopramide. Duration: Until the child completes 40 weeks of post menstrual age.
15997715|NCT02907619|Biological|PF-06252616|Either 5mg/kg, 20mg/kg or 40mg/kg will be assigned to a subject based on their maximum tolerated dose from B5161002
15997716|NCT02907593|Drug|Budesonide in Calfactant|Budesonide in Calfactant
15997717|NCT02907580|Behavioral|Local educational information|Participants in this arm receive educational information regarding influenza vaccination based on local educational information.
15997718|NCT02907580|Behavioral|National educational information|Participants in this arm receive educational information regarding influenza vaccination based on national educational information.
15997719|NCT02907567|Drug|CT1812|Active study drug
15997720|NCT02907567|Drug|Placebo|non-active study drug
15997721|NCT02907554|Drug|cyclosporine A|the intervention group receives 2.5 mg/kg of cyclosporine
15997722|NCT02907554|Drug|Placebo|control group receives a placebo
15997723|NCT02907541|Other|QI4U learning|Learners will have access to 8 QI methods modules on QI4U
15997724|NCT02907541|Other|Facilitated learning|Learners will have access to quarterly learning events and bespoke training on QI methods through facilitated peer-to-peer learning workshops
15997725|NCT02907541|Other|QI4U and Facilitated learning|Learners will have access to the 8 QI modules on QI4U and attend quarterly learning events and bespoke training on QI methods through peer-to-peer learning workshops
15997726|NCT02907528|Biological|Bone|Furcation defect regenerated with bone graft material
15997727|NCT02907528|Biological|EMD|Furcation defect regenerated with EMD
15997728|NCT02907515|Device|cm-loc attachment|cm-loc is a new implant attachment mechanism with resin matrix housing to retain the overdenture
15997729|NCT02907515|Device|ball attachment|ball attachment is the gold slandered attachment mechanism with nylon cap and metal housing to retain the overdenture
15997730|NCT02907502|Dietary Supplement|Young-child formula with low protein content|Young-child formula with low protein content
15997731|NCT02907502|Dietary Supplement|Young-child formula with protein content similar to that of cow's milk|Young-child formula with protein content similar to that of cow's milk
15997732|NCT02907489|Other|triple antibiotic paste with an anti-inflammatory drug|Mixture of ciprofloxacin, metronidazole and minocycline.and diclofenac potassium 50 mg (Catafast)
15997733|NCT02907476|Behavioral|Iyengar Yoga|
15997734|NCT02907476|Behavioral|Walking|
15997735|NCT02907450|Device|TwiCare®.|
15997736|NCT02907437|Drug|Minocycline|Minocycline as an add-on drug (200 mg/day)
15997737|NCT02907437|Drug|Placebo|(200 mg/day)
15997738|NCT02907437|Other|Probiotics|(450 mg/day)
15997739|NCT02907424|Dietary Supplement|2 months of treatment|standard 2 months of treatment
15997740|NCT02907411|Other|Quadrivas Therapy|Quadrivas therapy will be applied to subjects. Quadrivas therapy is a intensive massage therapy for different tissues. Subjects will receive 12 treatments. The first lasting 2.5 hours and the remaining 11 lasting 1.5 hours.
15997743|NCT02907385|Device|LifeSeal™ Kit|LifeSeal™ Kit is applied as an additional protective layer over a stapled anastomosis
15997744|NCT02907372|Other|neuropsychologic evaluation|
15997745|NCT02907372|Other|oncogeriatric evaluation|
15997746|NCT02907359|Drug|Guadecitabine|Guadecitabine regimen is 60 mg/m2 given SC daily on Days 1-5 in 28-day cycles (delayed as needed to allow blood count recovery). Treatment should be given for at least 6 total cycles in absence of unacceptable toxicity or disease progression requiring alternative therapy.
15997747|NCT02907359|Other|Treatment Choice|"BSC: according to standard/institutional practice; includes RBC or platelet transfusions; growth factors, ie, erythropoiesis stimulating agents, granulocyte stimulating factors, iron chelating therapy; broad spectrum antibiotics and/or antifungals.
~Low dose cytarabine: 20 mg/m2 SC or IV QD for 14 days in 28-day cycles. Other schedules allowed per institutional practice. Treatment for ≥4 cycles absent disease progression/toxicity. BSC per institutional/standard practice.
~Standard Intensive Chemotherapy: recommended 7+3 given as cytarabine 100-200 mg/m2/day continuous infusion for 7 days and an anthracycline for 3 days. Anthracyclines per institutional practice include daunorubicin (45-60 mg/m2/day) or idarubicin (9-12 mg/m2/day) or mitoxantrone (8-12 mg/m2/day) by IV infusion. Subjects with complete or partial response after IC induction should receive ≥1 additional cycles with reduced cytotoxic doses then BSC per standard /institutional practice."
15997748|NCT02907346|Behavioral|Reinforcement for wearing CGM|The intervention will reinforce patients for wearing CGM and for uploading it and reviewing its data.
15997749|NCT02907333|Behavioral|Advice to use condoms|
15997750|NCT02907320|Drug|CYCLO 3 ® FORT|
15997751|NCT02907320|Drug|MPFF|
15997752|NCT02907320|Drug|placebo CYCLO 3 ® FORT|
15997753|NCT02907320|Drug|placebo MPFF|
15997754|NCT02907307|Device|LactiSal vaginal gel 1%|to be administered daily intravaginally for 6 days
15997755|NCT02907307|Device|LactiSal vaginal tablet 50mg|to be administered daily intravaginally for 6 days
15997756|NCT02907307|Drug|Clotrimazole vaginal tablet 100mg|to be administered daily intravaginally for 6 days
15997757|NCT02907294|Drug|PBF-999 / 160 mg|2 capsule 80 mg x 8 days
15997758|NCT02907294|Drug|PBF-999 / 320 mg|4 capsule 80 mg x 8 days
15997759|NCT02907294|Drug|Placebo|2 capsules of placebo x 8 days 4 capsules of placebo x 8 days
15997760|NCT02907281|Other|Observational|Observational
15997761|NCT02907268|Drug|onabotulinumtoxinA|OnabotulinumtoxinA (Botox; Allergan) was approved by the FDA in 2002. Intervention administered by study nurse. Intradermal administered in a regular 1 cm2 grid across the cheeks and forehead. Intramuscular administered as per normal practice.
15997762|NCT02907268|Drug|abobotulinumtoxinA|AbobotulinumtoxinA (Dysport; Galderma) was approved by the FDA in 2009. Intervention administered by study nurse. Intradermal administered in a regular 1 cm2 grid across the cheeks and forehead. Intramuscular administered as per normal practice.
15997763|NCT02907255|Device|Oximetry monitor|Wireless respiratory monitoring system
15997764|NCT02907242|Other|Revealment|Cerebroplacental ratio revealment
15997765|NCT02907229|Device|NCVC-CS1|Intervention Description
15997766|NCT02907216|Biological|Squarekids|Three doses administered subcutaneously in the upper arm or thigh
15997767|NCT02907216|Biological|Rotarix|Two doses administered orally
15997768|NCT02907190|Other|Bean Type|1/2 cup of freshly boiled beans will be eaten by participants on separate study visits
15997769|NCT02907190|Other|Starchy Foods|1/2 cup serving of one of 4 starchy foods will be eaten by participants on different study visit
15997770|NCT02907177|Drug|Ponesimod|One tablet of ponesimod 20 mg administered orally once daily in the morning from Day 15 to EOT. To reduce the first-dose effect of ponesimod, an uptitration scheme will be implemented from Day 1 to Day 14 (with dose strength increasing from 2 mg to 20 mg).
15997771|NCT02907177|Other|Placebo|One tablet of matching placebo administered orally once daily in the morning
15997772|NCT02907164|Behavioral|Email invitation|Receive emails encouraging them to sign up
15997773|NCT02907164|Behavioral|Social norm|Receive information about how many people have signed up
15997774|NCT02907164|Behavioral|Intrinsic, health motive|Receive information about how the challenge helps people to stay fit in a fun way
15997775|NCT02907164|Behavioral|Extrinsic, reward motive|Receive information about how the challenge helps people to stay active and earn rewards
15997776|NCT02907151|Other|Survey|Complete a survey prior to the consultation and a questionnaire after
15997777|NCT02907138|Other|Medical Yoga|
15997778|NCT02907138|Other|Treatment as Usual (physical therapy)|
15997779|NCT02907125|Behavioral|SEHER Intervention delivered by TSM|"SEHER Intervention The SEHER intervention will be delivered by a trained teacher, called as Teacher-as-SEHER Mitra (Mitra meaning friend) or lay health worker called as SEHER Mitra being trained to facilitate following activitiesAwareness generation activities for all stakeholders in school; Wall-magazine, Speak-out box, Competitions, School Health Promotion Committee, School health policies, Peer groups of students of class IX and X students, Workshops and talks for all the students from standard IX, and for teachers, and Counselling and referral services for all the students in the school.
~This intervention will be delivered in each school over the academic year."
15998265|NCT02903095|Drug|Placebo|
15997780|NCT02907125|Behavioral|SEHER Intervention delivered by SM|"The SEHER intervention will be delivered by a lay health worker called as SEHER Mitra being trained to facilitate following activities: Awareness generation activities for all stakeholders in school; Wall-magazine, Speak-out box, Competitions, School Health Promotion Committee, School health policies, Peer groups of students of class IX and X students, Workshops and talks for all the students from standard IX, and for teachers, and Counselling and referral services for all the students in the school.
~This intervention will be delivered in each school over the academic year."
15997781|NCT02907125|Behavioral|Tarang AEP|The comparison arm involves 'usual care' which in the study setting is the Tarang: Adolescence Education Programme comprising of 16 classroom sessions on process of growing-up, prevention of HIV/AIDS and other Sexually Transmitted Diseases (STDs), and prevention of substance and other drug abuse. This programme is delivered by a trained nodal teacher in the school over the academic year.
15997782|NCT02907112|Behavioral|Meat reduction|Advice, Motivational material and food products provided to participants
15997783|NCT02907099|Drug|CXCR4 Antagonist BL-8040|Given SC
15997784|NCT02907099|Biological|Pembrolizumab|Given IV
15997785|NCT02907099|Other|Pharmacological Study|Correlative studies
15997786|NCT02907086|Other|blood collection|
15997787|NCT02907073|Drug|BF4|Single IV dose of 9-11 millicurie (mCi) sodium [Fluorine-18] radiolabeled B4^F
15997788|NCT02907060|Device|Mechanical cervical ripening|"The mechanical cervical ripening is a double transcervical balloon. The device used in the study is the Cook® Cervical Ripening Balloon with CE marked (commercialized by the Cook® laboratory, ref JCRBS-184000). It is a silicone double balloon catheter. Maximum balloon inflation is 80 mL/balloon.
~It will be used in accordance with user manual"
15997789|NCT02907060|Drug|Pharmacological cervical ripening|"The comparative pharmacological procedure is a vaginal slow releasing system of dinoprostone. The form used in the study is Propess (Ferring pharmaceuticals) containing 10mg of dinoprostone (prostaglandin E2).
~It will be used in accordance with Summary of Product Characteristics"
15997790|NCT02907047|Other|tourniquet inflated|
15997791|NCT02907047|Other|tourniquet not inflated|
15997792|NCT02907034|Procedure|Virtual reality experimentation sequency (VR)|
15997793|NCT02907034|Procedure|Classical narrative approach (CN)|
15997794|NCT02907021|Drug|standard-of-care treatments for LV impairment|Treat patients with mild or moderate LV impairment by standard-of-care treatments for LV impairment using ACE-I and beta-blockers
15997795|NCT02907008|Other|Polysomnography|
15997796|NCT02906995|Drug|Sublingual tablet 4 mg versus Nicorette Lozenge 4mg|"One dose of study drug (sublingual tablet or Nicorette Lozenge) will be administered to each subject in the morning on Day 1.
~The second administration of drug will occur at least 48 hours after the initial administration. Subjects will receive the other dosage form and be instructed according to whether they are receiving the sublingual tablet or the lozenge."
15997797|NCT02906982|Other|Gum health formulation in intra-oral device|The intervention is a gum health formulation for periodontal disease care and teeth whitening to be used within an accelerating intra-oral device.
15997798|NCT02906982|Other|Gum health formulation on toothbrush|The intervention is a gum health formulation for periodontal care and teeth whitening to be used on a toothbrush alongside standard toothpaste.
15997799|NCT02906969|Other|Colonoscopy Educational Video|Brief Video utilization to assess comprehension and evaluation bowel preparation quality
15997800|NCT02906969|Other|Placebo Educational Video|Brief Video utilization to provide placebo information and evaluation bowel preparation quality
15997801|NCT02906956|Behavioral|Preferred music playlist|Client will be instructed in a home program based on repetitive task practice principles and will complete this program with and without the use of a preferred music playlist during practice.
15997802|NCT02906930|Drug|semaglutide|Oral administration once daily.
15997803|NCT02906930|Drug|placebo|Oral administration once daily.
15997804|NCT02906917|Drug|Insulin degludec/insulin aspart|Administered subcutaneously (s.c. under the skin) once daily.
15997805|NCT02906917|Drug|Insulin glargine|Administered subcutaneously (s.c. under the skin) once daily.
15997806|NCT02906917|Drug|Insulin aspart|Administered subcutaneously (s.c. under the skin) once daily.
15997807|NCT02906904|Other|Case Intervention|24-hour sleep deprivation protocol, polysomnographic monitoring of the recovery sleep, triggering of parasomniac episodes by auditory stimulations, thermoalgic stimulation (Modulator Sensory Analyzer Thermal Stimulator®) during wakefulness, parasomniac episodes, NREM stage 2 ans SWS
15997808|NCT02906904|Other|Control Intervention|24-hour sleep deprivation protocol, polysomnographic monitoring of the recovery sleep, thermoalgic stimulation (Modulator Sensory Analyzer Thermal Stimulator®) during wakefulness, NREM stage 2 ans SWS
15997809|NCT02906891|Device|Vigilant Diabetes Management Application|The Vigilant Diabetes Management Companion by InSpark Technologies was developed to assist in the prevention of hypoglycemia by providing the individual with an unobtrusive analysis of their blood glucose values and notifying them about periods of upcoming risk for low and high blood glucose; and in particular periods of risk for severe hypoglycemia. This allows the individual to take preventive corrective action. Subjects will download the Vigilant DiabetesManagement Application and use it in conjunction with a study supplied wireless blood glucose meter. They will check blood glucose values at least three times a day and receive summaries and notifications from Vigilant regarding periods of risk and blood glucose patterns.
15997810|NCT02906878|Procedure|Platelets transfusion|Prophylactic platelet transfusion in thrombocytopenic patients for the placement of a central venous catheter
15997811|NCT02906865|Other|Proximal hamstring tendons repair|Proximal hamstring tendons repair
15997812|NCT02906839|Other|Intervention group|Just after AF ablation, nocturnal polygraphy will be performed to diagnose SAS. If present and AHI >15/h, the SAS will be treated, based on type and severity of SAS and on patient tolerance to treatment.
15997813|NCT02906826|Device|Video game|Video game operated by performing therapy correctly
15997814|NCT02906813|Drug|TAK-935 Tablets|Tablets
15997815|NCT02906813|Drug|TAK-935 Oral Solution|Oral solution
15997899|NCT02906111|Drug|estriol|"Study Group, treated with estriol
~Control Group, no drug treatment
~Both groups will undergo vaginal surgery for prolapse"
15997900|NCT02906111|Procedure|vaginal surgery|Control Group
15998266|NCT02903082|Biological|Residue of blood further to NFS|
15997816|NCT02906800|Drug|Digoxin|The digoxin dose will be adjusted to achieve a plasma concentration of 0.6-1.2 ng/ml according to current recommendations in heart failure patients (doses adapted to renal function, comorbidities, concomitant medications, age, and plasma concentration). The risk related to digoxin treatment will be minimized in our study since the duration of exposure to digoxin will be limited to 9 days every 3 weeks for 3 cycles (total duration of treatment 27 days).
15997817|NCT02906787|Behavioral|BAS+|The goal of the BAS+ is to maintain a level of overall reward after cessation by structuring and enhancing opportunities for reinforcement to: (1) ensure that not smoking is as reinforcing as smoking; and (2) prevent an over-reliance on food as a substitute reinforcer for smoking so that PCWG does not precipitate smoking relapse.
15997818|NCT02906787|Behavioral|SC|Overeating and weight gain are common concerns reported during smoking cessation treatment. Per convention, SC will address these concerns through standard recommendations to consume low-calorie snack foods, drink water, eat nutritious meals, and exercise, but will not include skills to shape the use of these suggestions.
15997819|NCT02906774|Biological|Fecal microbiota transplantation (FMT)|Fecal microbiota transplantation after antibiotic pretreatment
15997820|NCT02906761|Drug|Aspirin|Aspirin 600 mg (2 tablets of 300 mg) twice daily for 6 months
15997821|NCT02906761|Drug|Placebo|Placebo (2 tablets) twice daily for 6 months
15997822|NCT02906748|Procedure|injection with a syringe in new-site for parathyroid autografting|new-site for parathyroid autografting, close to the antecubital vein
15997823|NCT02906748|Procedure|injection with a syringe in traditional site for parathyroid autografting|traditional-site for parathyroid autografting,not intensively close to the antecubital vein
15997824|NCT02906735|Procedure|Surgery|Implantation of knee joint prosthesis or deviation osteotomies of the knee
15997825|NCT02906722|Drug|Intravenous colimycin|administration once, twice or 3 times per day according to renal function
15997826|NCT02906722|Drug|Intravenous placebo|administration once, twice or 3 times per day according to renal function
15997827|NCT02906722|Drug|Nebulized colimycin|Nebulization is performed with a vibrating plate nebulizer (Aeroneb® Solo) every 8h
15997828|NCT02906722|Drug|Nebulized placebo|Nebulization is performed with a vibrating plate nebulizer (Aeroneb® Solo) every 8h
15997829|NCT02906709|Drug|Omarigliptin|Omarigliptin, 25 mg orally once weekly
15997830|NCT02906709|Drug|Placebo|Placebo to omarigliptin orally once weekly
15997831|NCT02906709|Biological|Insulin|Insulin will be administered subcutaneously during the trial as monotherapy; dosage and administration following each package insert.
15997832|NCT02906696|Drug|Bosutinib|Given PO
15997833|NCT02906696|Other|Laboratory Biomarker Analysis|Correlative studies
15997834|NCT02906683|Drug|TAS-303|Oral administration for 8 weeks, once daily.
15997835|NCT02906683|Drug|Placebo|Oral administration for 8 weeks, once daily.
15997836|NCT02906670|Drug|Sym013|Sym013 is a recombinant antibody mixture containing 6 humanized immunoglobulin G1 (IgG1) monoclonal antibodies (mAbs), which bind specifically to non-overlapping epitopes or domains on the epidermal growth factor receptor (EGFR), and the human epidermal growth factor receptors (HER) HER2 and HER3.
15997837|NCT02906657|Other|Medication reconciliation|The medication reconciliation list will be compared to the drugs prescribed by the hospital physician at admission and discrepancies will be analyzed by discussion between the physician and the pharmacist
15997838|NCT02906644|Drug|lorcaserin|
15997839|NCT02906644|Drug|nicotine patch|
15997840|NCT02906644|Drug|placebo lorcaserin|
15997841|NCT02906618|Drug|LY3039478|Administered orally
15997842|NCT02906618|Drug|3C 15N 2H-LY3039478 IV|Administered IV
15997843|NCT02906605|Drug|JNJ-809|JNJ-809 (1*10^9) colony forming units (CFU) given as an infusion.
15997844|NCT02906605|Drug|Apalutamide|Apalutamide 240 mg orally daily.
15997845|NCT02906579|Drug|Matching Placebo|
15997846|NCT02906579|Drug|IW-1973|
15997847|NCT02906566|Drug|Retinol|Retinol in the form of vitamin A lotion
15997848|NCT02906566|Drug|Placebo|Placebo of Retinol
15997849|NCT02906553|Drug|Glyceryl Trinitrate|
15997850|NCT02906553|Drug|Placebo|
15997851|NCT02906540|Procedure|Transpubic symphysis reset therapy group|The patients in the treatment group will undergo daily transpubic symphysis reset therapy for 7 consecutive days.
15997852|NCT02906540|Procedure|Physiotherapy group|The patients in the control group will undergo physiotherapy and a sham treatment.
15997853|NCT02906527|Drug|Non-exposed group|Non-exposed group / Patients receiving VKA
15997854|NCT02906527|Drug|Exposed group|Exposed group / Patients receiving DOAC
15997855|NCT02906514|Drug|Non balanced Hydroxyethyl starch 130/0.4 (Voluven®, Fresenius)|1000mL used for cardiopulmonary bypass priming
15997856|NCT02906514|Drug|Sodium Chloride 0.9% (Fresenius)|1000mL used for cardiopulmonary bypass priming
15997857|NCT02906501|Procedure|The Penn Web-Based Computerized Neurocognitive Battery|The Battery (PennCNP) of the Brain Behavior Laboratory at the University of Pennsylvania offers a range of probes of human neuropsychological functioning . It was designed for neuropsychological measurement of major cognitive domains. The WebCNP is administered using clickable icons on desktop or laptop computers, in a fixed order. Administrating the tests in a standard fashion fostering optimal performance without aiding the participant is required. For each domain, accuracy and speed are computed. Full battery completion takes approximately 2 hours. Each test begins with a practice module, to assure understanding of the instructions.
15997858|NCT02906501|Procedure|The Iowa Gambling Test (IGT)|The essential feature of this task is that it mimics real-life situations in the way it factors uncertainty, reward and punishment. The task involves four decks of cards, named A, B, C and D. The goal is to maximize profit on a loan of play money. Subjects are required to make a series of 100 card selections, but are not told ahead of time how many card selections they are going to be allowed to make. Cards can be selected one at a time, from any deck, and subjects are free to switch from any deck to another, at any time and as often as they wish. The decision to select from one deck or another is largely influenced by schedules of reward and punishment. These schedules are pre-programmed and known to the examiner, but not to the subject (Bechara et al., 1994, 1999a).
15997859|NCT02906475|Other|standardized skin care regimen|"Application of a standardized daily skin care regimen:
~milk lotion once daily and
~application of addendum for bathing as needed"
16051554|NCT02514681|Drug|Gemcitabine|
15997860|NCT02906462|Other|Early consideration of vulnerability|One day training with the provision of vulnerability criteria inciting an early reflection of the level of therapeutic engagement; sheets available on the internet computer support collegial reflection and traceability of decisions to limit and stop treatments, incorporating the provisions of law known Leonetti
15997861|NCT02906462|Other|Usual practices|the centres applies their usual practices
15997862|NCT02906449|Behavioral|Meditation Technique|Alertness training or relaxation training
15997863|NCT02906436|Device|Xvivo Chamber|
15997864|NCT02906423|Other|PROMIS-10 questionnaire|Patient completed a PROMIS-10 questionnaire
15997865|NCT02906410|Other|Item-Level Calorie information|Information identifying the calorie content of individual items will be provided, as would be done on a restaurant menu board.
15997866|NCT02906410|Other|Meal-Level Calorie information|"Information from the calorie content of individual items that have been selected by the participant will be dynamically aggregated and presented as a Total Calories label on the menu screen."
15997869|NCT02906384|Radiation|hippocampus avoidance|conformal avoidance of the hippocampal neural stem-cell compartment during prophylactic cranial irradiation
15997870|NCT02906371|Drug|Tocilizumab|Patients with ≥ 40% blasts in the bone marrow at pre-infusion will be enrolled in the early tocilizumab cohort and will follow early CRS treatment algorithm.
15997871|NCT02906371|Drug|Tocilizumab|Patients with ˂ 40% blasts in the bone marrow at pre-infusion (~ Day -5 to -1) will follow the standard CRS Rx algorithm
15997872|NCT02906371|Biological|CART 19|CART-19 cells transduced with a lentiviral vector to express either anti-CD19ζ scFv TCRζ:41BB, administered by i.v. injection using an intra-patient dose escalation approach: 10% on day 0, 30% on day 1 with a total dose goal of ~1.5 x107 - 5 x109 (~3x105 - 1x108/kg) T cells.
15997873|NCT02906358|Behavioral|Community-based pain self-management|
15997874|NCT02906358|Behavioral|Clinic-based pain self-management|
15997875|NCT02906345|Device|Therapeutic Plasma Exchange (TPE)|All treated patients should treated two (minimal) to five times by TPE, depending on the need of norephinephrine for the therapy. For each session 40 ml/kg body weight plasma should be exchange. Fluid resuscitation will be done with fresh frozen plasma.
15997876|NCT02906332|Drug|Pembrolizumab|Pembrolizumab 200 mg IV every 3 weeks x 2 cycles. This is followed by followed by pembrolizumab 200 mg IV every 3 weeks for 2 additional cycles.
15997877|NCT02906332|Drug|Lenalidomide|Lenalidomide 25 mg po daily x 14 days once weekly for a 21-day cycle x 2 cycles. This is followed by lenalidomide 25 mg po daily x 14 days for a 21-day cycle x 2 cycles for 2 additional cycles.
15997878|NCT02906332|Drug|Dexamethasone|Dexamethasone 40 mg po once weekly for a 21-day cycle x 2 cycles only.
15997879|NCT02906306|Behavioral|Individual Occupational Therapy|45 minutes 3 times per week 6 months in nursing homes (A and B)
15997880|NCT02906306|Behavioral|Group Occupational Therapy|45 minutes 3 times per week 6 months in nursing homes (A and B)
15997881|NCT02906293|Other|Abdominal acoustic measurement|"On Day 1 participants will record their intestinal rate at baseline fasting, pre-small meal, and upon completion of the meal. On Day 2 participants will record their intestinal rate at baseline fasting, pre-large meal, and upon completion of meal."
15997882|NCT02906280|Device|EBUS-TBNA needle|tissue sampling
15997883|NCT02906267|Other|Diagnostic ultrasonography of gastric volume|Ultrasonic measurement of gastric insufflation during positive pressure ventilation (secondary endpoint) and final gastric volume after positive pressure ventilation (primary endpoint)
15997884|NCT02906254|Other|ECIL-4 guidelines group|Antibiotics were stopped when patients had been afebrile for more than 48 hours
15997885|NCT02906254|Other|Short-course antibiotic therapy|Antibiotics were stopped on day 5 in febrile or afebrile patients
15997886|NCT02906241|Behavioral|Patients: Questions to Ask Your Doctor: A Workbook for Patient-Doctor Teams|This booklet encourages patients to view themselves as members of the patient-doctor team and to participate actively during clinical interactions by asking questions and stating concerns.
15997887|NCT02906241|Behavioral|Physicians: Educational Module|Physicians will participate in an educational module and receive email prompts to encourage them to discuss trials with all patients who are eligible for a clinical trial, using patient-centered communication
15997888|NCT02906228|Radiation|Exposure within the given regulatory limits for non-ionizing electromagnetic fields according to ICNIRP guidelines and German law|
15997889|NCT02906215|Behavioral|Care Coordination Intervention|cross-training in HIV/PrEP and substance use, plus a digital health tool to improve evidence-based screening, brief intervention, referral to treatment, and patient management across HIV, PrEP, and addiction treatment providers
15997890|NCT02906202|Genetic|LentiGlobin BB305 Drug Product|LentiGlobin BB305 Drug Product is administered by IV infusion following myeloablative conditioning with busulfan.
15997891|NCT02906189|Radiation|MRI|
15997892|NCT02906176|Drug|Vfend (voriconazole) intravenous infusion|Vfend (voriconazole) 200 mg intravenous infusion during 1.5 h
15997893|NCT02906176|Drug|Vfend (voriconazole) tablet|Vfend (voriconazole) 200 mg tablet once
15997894|NCT02906163|Drug|Thymalfasin (Thymosin alpha 1, Ta1)|In Phase I patients will be randomized to one of two different dosing regimens of Thymosin alpha 1 for a treatment duration of 4 months. At the completion of Phase I, data will be reviewed and a single dosing regimen will be carried forward into Phase II.
15997895|NCT02906163|Drug|SoC (tyrosine kinase inhibitor)|In Phase II patients will be randomized to SoC or Thymosin alpha 1 plus SoC for treatment duration of 12 months. All patients will be followed for approximately 18 months.
15997896|NCT02906150|Drug|Thymalfasin (Thymosin alpha 1, Ta1)|Patients will be randomized to Thymosin alpha 1 plus SoC for treatment duration of 12 months. All patients will be followed for approximately 12 months or until the total number of PFS events required will be observed.
15997897|NCT02906150|Drug|SoC (chemotherapy and platinum agent)|Patients will be randomized to SoC for treatment duration of 12 months. All patients will be followed for approximately 12 months or until the total number of PFS events required will be observed.
15997898|NCT02906137|Other|Peripheral blood and intestinal biopsies will be collected|Blood draw and intestinal biopsies
15998642|NCT02900040|Other|kidney transplantation|
15997901|NCT02906098|Behavioral|Patient centered oral health education|Procedure: The theory-based educational intervention follows a specific structure. The initial phase contain 3 treatment sessions (45-60 min each) during a period of 12 weeks (baseline, 2-3 weeks and 10-12 weeks). Follow up are performed at 6- and 18-months.
15997902|NCT02906098|Behavioral|Standard educational intervention|Procedure: The initial phase contain educational intervention in accordance with conventional routines (oral health information and oral hygiene instruction at one or several occasions). Follow up are performed at 6- and 18-months.
15997903|NCT02906085|Drug|Endothelin-1|
15997904|NCT02906085|Drug|Placebo|Isotonic saline
15997905|NCT02906072|Behavioral|Low fat plant-based diet|Conventional low fat plant-based meals three times daily. Plant-based meal replacements: Herbalife European Free From vanilla two times daily. Portion sizes and intake is unrestricted.
15997906|NCT02906072|Behavioral|Lectures on health effects of a low fat plant-based diet.|Participants attend the lectures on health effects of a low fat plant-based diet.
15997907|NCT02906059|Drug|AZD1775|
15997908|NCT02906059|Drug|Irinotecan|
15997909|NCT02906046|Device|Weight in Lower Limbs|
15997910|NCT02906033|Other|New perioperative practice model|The one and same anesthesia nurse takes care of the patient during the entire perioperative process and even pays the patient a visit to the ward the day after surgery.
15997911|NCT02906020|Drug|venglustat GZ/SAR402671|Pharmaceutical form: capsule Route of administration: oral
15997912|NCT02906020|Drug|Placebo|Pharmaceutical form: capsule Route of administration: oral
15997913|NCT02906007|Drug|Bedaquiline|"100 mg oral tablets.
~Doses will vary based on the participant's age and weight."
15997914|NCT02905994|Drug|Volasertib|Polo-Like Kinase Inhibitor
15997915|NCT02905994|Drug|Cytarabine|Standard chemotherapy at dosage and schedule for 7+3 induction
15997916|NCT02905994|Drug|Idarubicin|Standard chemotherapy at dosage and schedule for 7+3 induction
15997917|NCT02905994|Procedure|Bone Marrow Biopsy|Bone marrow biopsy assessments scheduled during induction to assess response
15997918|NCT02905981|Drug|Fer-In-Sol|Fer-In-Sol is an over-the-counter oral iron supplement. It will be administered during Period 1 at a dose of 3 mg/kg body weight.
15997919|NCT02905981|Drug|Shohl's solution|Shohl's solution will be supplied as 500-milliliter (mL) bottles containing citric acid United States Pharmacopeia (USP) 640 milligrams per 5 milliliters (mg/5 mL) and hydrous sodium citrate USP 490 mg/5 mL. It will be administered during all Periods at a dose of 0.67 mmol/kg body weight.
15997920|NCT02905981|Drug|Triferic|Triferic is an iron salt that is approved by the Food and Drug Administration (FDA) for the maintenance of hemoglobin in patients with end stage kidney disease on hemodialysis. It is experimental in this study because it has not yet been approved for patients with IRIDA. It will be administered during Period 1 at a dose of 3 mg/kg body weight. In Periods 2 and 3 the dose may be adjusted based on lab results.
15997921|NCT02905968|Device|transanual tube placement|Transanual tube placement after anastomosis in low anterior resection for rectal cancer.
15997922|NCT02905955|Device|Prevena, KCI, Acelity, NPWT|All patients will receive a Prevena NPWT (if inclusion criteria are met)
15997923|NCT02905942|Drug|PEG-rhG-CSF|PEG-rhG-CSF was given day +1 after autologous stem cell transplantation with a dose of 100μg/kg(bw).For patients more than 45kg, 6mg was suggested.
15997924|NCT02905942|Drug|rhG-CSF|rhG-CSF was given day +1 after transplantation with a dose of 5μg/kg once per day
15997925|NCT02905929|Device|ActivPAL inclinometer|Participants will wear a thigh-worn inclinometer for the first 3 weeks of the intervention, and at the mid-point of the intervention. The device will monitor their sitting and standing time.
15997926|NCT02905929|Behavioral|Phone counseling call: Breaking up sitting time|Participants will receive 5 counseling phone calls to check-in on goal setting, strategies, and tools.
15997927|NCT02905929|Behavioral|In-person counseling: Breaking up sitting time|Participants will receive 3 in-person health education sessions. At these sessions participants will receive feedback from the ActivPAL showing periods throughout the day where participants have been sitting. Participants will also develop action plans, check-in on goal setting, and use of tools at these sessions.
15997928|NCT02905929|Behavioral|Phone counseling call: Healthy living|Participants will receive a healthy living educational intervention over the phone, developed and tested by the investigators in previous studies. Participants will not receive any information on diet, physical activity or sedentary behavior that may affect the outcomes.
15997929|NCT02905929|Other|Tools to prompt standing|Investigators will provide standing desks to participants who spend time sitting at a computer. Additional tools to help prompt standing are mechanical and electronic timers set to interrupt long periods of sitting and cues in the environment such as standing during commercial breaks and phone calls.
15997930|NCT02905929|Behavioral|In-person counseling: Healthy living|Control subjects will receive one in-person counseling session about healthy living. Participants will not receive any information on diet, physical activity or sedentary behavior that may affect the outcomes.
15997931|NCT02905916|Drug|PEG-rhG-CSF|
15997932|NCT02905903|Drug|Tricholoacetic Acid (TCA)|We will be applying 4 concentrations of TCA (20%, 25%, 30%, 35%) to the buttocks to two spots each (total of 8 lesions) and following characteristics of these lesions and comparing them to acne induced PIH during the course of the study.
15997933|NCT02905890|Drug|Norethisterone enantate|Noristerat® 200mg, solution for intramuscular injection given every 8 weeks
15997934|NCT02905890|Device|Condoms|Latex male condoms
15997935|NCT02905877|Other|Behavioural study|reaching studies and other behavioural studies.
15997936|NCT02905864|Drug|Liraglutide 3 mg (Saxenda)|
15997937|NCT02905864|Drug|Liraglutide 3 mg placebo|
15997938|NCT02905851|Other|Feedback group|Monitoring ability to use teledermatology to modify antibiotic burden
15997939|NCT02905851|Other|Non Feedback group|To use as control to see if antibiotic burden has been reduced in the active feedback group
15997940|NCT02905838|Device|Anatomic e.max Abutment|Implant-supported single crown was fabricated using a prefabricated stock abutment made of yttrium oxide partially stabilized tetragonal zirconia polycrystalline (Y-TZP) (Anatomic IPS e.max Abutment, straight, color M1, Ivoclar, Liechtenstein) and pressed ceramic (fluorapatite glass-ceramic, IPS e.max ZirPress, Ivoclar, Liechtenstein) using the cut-back technique and hand veneered with a thin layer of fluorapatite veneering ceramic (fluorapatite veneering ceramic, IPS e.max Ceram, Ivoclar, Liechtenstein).
15997941|NCT02905838|Device|CAD/CAM CARES Abutment|"Implant-supported single crown was fabricated using an individualized CAD/CAM abutment made of Y-TZP (CARES® Abutment, Institut Straumann AG, Basel, Switzerland) and hand build-up veneering ceramic technique (fluorapatite veneering ceramic, IPS e.max Ceram, Ivoclar, Liechtenstein).
~All implant-supported crowns were fabricated in the same dental laboratory by the same dental technician (Dominique Vinci, Geneva, Switzerland). The implants were placed by experienced oral surgeons in a prosthetic ideal position."
15997942|NCT02905825|Device|BreathID® Hp System|Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea
15997943|NCT02905825|Drug|BreathID® Hp Lab System|Breath will be analyzed for change in carbon 13 content in breath after ingestion of carbon 13 enriched urea
15997944|NCT02905825|Diagnostic Test|Stool Test|Each subject was asked to perform a stool test in parallel to the breath test.
15997945|NCT02905812|Other|RGI & Massage|A trained intervention nurse will administer a 15 min moderate pressure massage as well as guided imagery with music once daily for up to five consecutive days.
15997946|NCT02905799|Drug|oral resveratrol|Resveratrol will be administered orally, at the dose of 40 mg (2 caplets) twice a day for one week, then at the dose of 20 mg (1 caplet) twice a day, for a total duration of 6 months.
15997947|NCT02905799|Drug|oral placebo|Placebo will be administered orally : 2 caplets twice a day for one week, then 1 caplet twice a day, for a total duration of 6 months
15997948|NCT02905786|Device|Cobas h232 (Roche Diagnostics)|NT-proBNP point-of-care test
15997949|NCT02905786|Other|Clinical audit and feedback|Clinical audit and feedback to detect previously unrecognized HF patients and inform GPs about their current quality of HF care
15997950|NCT02905786|Other|Assistance by a specialized HF nurse|Assistance by a specialized HF nurse in general practice for education of patients, advice in diagnosis and treatment, transition of care
15997951|NCT02905773|Other|root canal therapy|effect of devices ( ProTaper and Reciprocal Files)
15997952|NCT02905773|Other|root canal retreatment|effect of devices ( ProTaper and Reciprocal Files)
15997953|NCT02905760|Drug|Furosemide|"Furosemide: Special LASILIX (250 mg/25 ml) solution for injection reconditioned glass bottle like penicillin of 80mg/8mL. Injection by slow intravenous (1 to 2 minutes per 80mg vial)"
15997954|NCT02905760|Drug|Placebo filling|Placebo filling: Glucose 5%, 500mL infused over 30 minutes.
15997955|NCT02905760|Drug|Placebo furosemide|"Placebo furosemide: glucose 5% for injection reconditioned glass bottle like penicillin of 80mg/8mL. Injection by slow intravenous (1 to 2 minutes per 80mg vial)."
15997956|NCT02905760|Drug|Vascular filling|Vascular filling: Sodium 0.9% 500mL infused over 30 minutes.
15997957|NCT02905747|Behavioral|Medical Exercise Therapy|physiotherapy intervention with Medical exercise therapy (MET) during 3 months
15997958|NCT02905734|Drug|Nicotine patch|Single administration of an active treatment (nicotine patch)
15997959|NCT02905734|Other|placebo patch|Single administration of a placebo treatment
15997960|NCT02905721|Procedure|Spectral cardiac CT scan|Cardiac CT scan : acquisition using the spectral mode imaging in order to identify inflammatory areas of the myocardium on the iodine map imaging.
15997961|NCT02905708|Device|Air-Activated heating packs|The subject disrobe and will dress in a jacket, pants, gloves and socks (ensemble) which will be removed from a vacuum pack. He will be assisted by the nurse in pre-operative area. The ensemble will remain in place until the subject is fully recovered from anesthesia.
15997962|NCT02905708|Device|Forced Air Warming Device|forced air-warming inflatable device applied according to standard hospital protocol.
15997963|NCT02905695|Drug|Chirocaine|
15997964|NCT02905695|Other|Placebo|
15997965|NCT02905682|Drug|Desmopressin|
15997966|NCT02905682|Drug|Placebo|
15997967|NCT02905669|Device|EndoFLIP|Esophago-gastric junction distensibility will be assessed in patients thanks to impedance planimetry using EndoFLIP device
15997968|NCT02905656|Behavioral|Brief Advice|Psychoeducation
15997969|NCT02905656|Behavioral|Motivational Interviewing|Guides participants toward choosing to make a change in their behavior with a collaborative conversation.
15997970|NCT02905656|Behavioral|Rate Reduction|Reducing the number of cigarettes consumed.
15997971|NCT02905656|Drug|Pharmacological|Nicotine Replacement Therapy in the form of gum.
15997972|NCT02905656|Behavioral|MI+RR|Combination of reducing the number of cigarettes consumed while guiding the participant to make a change in their behavior.
15997973|NCT02905643|Other|Study subjects|This study does not include an intervention it is only observational.
15997974|NCT02905630|Other|Exercise training|high intensity aerobic interval training
15997975|NCT02905604|Device|dmPFC iTBS|2400 pulses/day over 10 week days over bilateral dmPFC using MagPro X100 and the cool D-B80 A/P coil
15997976|NCT02905604|Device|dmPFC Sham iTBS|Sham iTBS
15997977|NCT02905591|Drug|Radiation Therapy|Conformal radiation administered daily, Monday through Friday Total dose is 60 Gray (Gy) and is delivered in 2 Gy fractions. One fraction is delivered daily for a total of 30 fractions in 30 days
15997978|NCT02905591|Drug|Paclitaxel|"Administered intravenously (IV) Given the same day as carboplatin, but given before the carboplatin is administered
~the dose is 45 mg/m2 (standard dose)
~Administered weekly
~6 to 7 weeks of therapy, depending on when radiation starts
~Standardized dose reductions are used"
15997979|NCT02905591|Drug|Carboplatin|"Administered intravenously (IV) GIven the same day as paclitaxel, immediately after the paclitaxel infusion is done.
~Prescribed at area-under-the-curve (AUC) = 2 using the Cockroft-Gault formula (standard)
~Administered weekly
~6 to 7 weeks of therapy, depending on when radiation starts
~Standard dose reductions are used"
15997980|NCT02905591|Drug|Ascorbic Acid|"Administered intravenously
~75 grams per infusion; each infusion is about 2 hours
~3 infusion per calendar week
~The infusion is actively running for at least 20 minutes when radiation begins
~May be given while chemotherapy is delayed due to low counts
~Dose reductions are not used
~Given for 6 to 7 weeks, depending on when radiation starts"
15997981|NCT02905578|Drug|Gemcitabine|"Administered intravenously the same day as nab-paclitaxel and ascorbate Administered after nab-paclitaxel and before ascorbate
~given for 3 weeks out of the 4 week cycle
~standard dose reductions are used
~up to 2 cycles are administered before standard of care CT scan
~decision to continue therapy is based disease response to therapy as measured from the CT scan
~treatment continues until disease progression is identified"
16061591|NCT02443688|Drug|CTX-4430|
15997982|NCT02905578|Drug|nab-paclitaxel|"Administered intravenously the same day as nab-paclitaxel and ascorbate Administered after before gemcitabine and ascorbate
~given for 3 weeks out of the 4 week cycle
~standard dose reductions are used
~up to 2 cycles are administered before standard of care CT scan
~decision to continue therapy is based disease response to therapy as measured from the CT scan
~treatment continues until disease progression is identified"
15997983|NCT02905578|Drug|Pharmacological ascorbate|"Administered intravenously the same day as nab-paclitaxel and gemcitabine Administered after nab-paclitaxel and gemcitabine
~given 3 times weekly
~given for 4 weeks out of the 4 week cycle
~no dose reductions are used
~up to 2 cycles are administered before standard of care CT scan
~decision to continue therapy is based disease response to therapy as measured from the CT scan
~treatment continues until disease progression is identified"
15997984|NCT02905565|Drug|NBP Softgel Capsules|Take 4 capsules BID on an empty stomach at least 1 hour before food intake, and remain fasting at least 1 hour after dosing.
15997985|NCT02905565|Drug|Placebo|Take 4 capsules BID on an empty stomach at least 1 hour before food intake, and remain fasting at least 1 hour after dosing
15997986|NCT02905552|Other|No intervention|
15997987|NCT02905539|Drug|Iron Isomaltoside 1000|
15997988|NCT02905539|Drug|Ferric Carboxymaltose|
15997989|NCT02905526|Behavioral|Contraceptive instant messages|Contraceptive Instant messages
15997990|NCT02905526|Other|Mobile phone app|Mobile phone app
15997991|NCT02905513|Behavioral|Contraceptive app instant messages|
15997992|NCT02905513|Other|Mobile phone app|
15997993|NCT02905474|Other|Usual Care|Usual standard CKD care involves an outpatient clinic visit every 3 to 4 months (at minimum every 6 months) for a clinical assessment by their renal clinical care team.
15997994|NCT02905474|Device|Integrated mobile medication app|Use of mobile app to maintain, manage medication list on a smartphone device that allows for bidirectional transfer of medication information
15997995|NCT02905474|Device|Commercially available mobile medication app|Use of mobile app to manually record and maintain medication records with no integration to databases.
15997996|NCT02905461|Behavioral|Contraceptive text messages|
15997997|NCT02905461|Other|Text messages not about contraception|
15997998|NCT02905448|Other|Low fat plant-based nutrition|"Conventional low fat plant-based meals free from animal source foods three times daily.
~Plant-based meal replacement with Herbalife European Free From Vanilla formula two times daily.
~Herbal beverage two times daily. Dietary fiber supplements is taken three times daily (10-36w) and more high fat whole plant-based foods (avocado, tofu, seeds) Conventional food intake is taken ad libitum and no calorie counts or restrictions will be applied.
~From 10 to 36 weeks we added vitamin B12 and EPA+DHA fatty acid"
15997999|NCT02905435|Device|Biodegradable Temporizing Matrix|The Biodegradable Temporizing Matrix (BTM) (also known as NovoSorb BTM) comprises a completely synthetic, sterile, integrating dermal component (porous biodegradable polyurethane foam) and a temporary epidermal barrier component (a non-biodegradable polyurethane sealing membrane). These layers are adhered with a biodegradable polyurethane bonding layer. BTM will be implanted and fixed into position to close a debrided burn wound. After a period of integration, the sealing membrane is removed and a split skin graft is applied.
15998000|NCT02905422|Behavioral|H.E.A.L.T.H. II Intervention|12 month study with 6 month intervention phase and 6 month follow up phase. Participants will receive bi-weekly educational information pertaining to weight loss during the intervention phase. Participants will use online website to monitor weight, access meal plans, access weight loss information, and access fitness plans.
15998001|NCT02905409|Procedure|ILM peeling surgery|4PD or 2PD diameter of ILM peeling in surgery was given to patients with IMH (idiopathic macular hole)
15998002|NCT02905396|Device|Spinal cord stimulation|implantation of spinal cord stimulator
15998003|NCT02905383|Other|Exercise|A multi-component exercise program that consists of endurance training, progressive strength exercises and balance exercises.
15998006|NCT02905357|Device|OCT|Optical Coherence Tomography (OCT): Intracoronary imaging for amount and type of plaque as well as plaque rupture, ulceration, dissection and/or thrombosis.
15998007|NCT02905357|Other|CMR|Cardiac Magnetic Resonance Imaging (CMR): MRI of the heart to identify areas of infarction (damage) and/or edema (swelling).
15998008|NCT02905331|Drug|Guselkumab|Participants will receive 100 mg of Guselkumab as 100 mg/mL solution via SelfDose device.
15998009|NCT02905331|Drug|Placebo|Participants will receive matching placebo supplied in a PFS assembled in a SelfDose device.
15998010|NCT02905318|Drug|Palbociclib|125 mg orally on days 1-21 each 28 day cycle
15998011|NCT02905305|Device|Contour Advance electrode with controlled dose of dexamethasone base|The Combined Device consists of a standard cochlear implant receiver-stimulator coupled to a Contour Advance electrode loaded with a controlled dose of dexamethasone base.
15998012|NCT02905305|Device|Contour Advance electrode|Standard Contour Advance electrode
15998013|NCT02905292|Other|evaluation and treatment maneuver for BPPV|
15998014|NCT02905279|Behavioral|Biofeedback Relaxation Training|Participants will receive one-session biofeedback relaxation training (24 minutes) for anxiety reduction. Prior to biofeedback, participants will receive education about spiders and the development and maintenance of spider phobia.
15998173|NCT02903849|Behavioral|Treatment Reminders|Receive reminders containing the messages they leave themselves at three points during the challenge
15998015|NCT02905279|Behavioral|Exposure Therapy|Participants will receive one-session exposure therapy (24 minutes) for fear of spiders. Prior to exposure therapy, participants will receive education about spiders and the development and the development and maintenance of spider phobia.
15998016|NCT02905279|Behavioral|Exposure with Threat-Relevant Opposite Actions|Participants will receive one-session exposure therapy (24 minutes) for fear of spiders. During exposure, participants will engage in actions opposite to the tendencies associated with threat avoidance. Prior to exposure therapy, participants will receive education about spiders and the development and maintenance of spider phobia.
15998017|NCT02905279|Behavioral|Exposure with Threat-Irrelevant Opposite Actions|Participants will receive one-session exposure therapy (24 minutes) for fear of spiders. During exposure therapy, participants will engage in actions opposite of the action tendencies associated with the fear, but unrelated to the specific threats associated with spider phobia. Prior to exposure therapy, participants will receive education about spiders and the development and maintenance of spider phobia.
15998018|NCT02905266|Biological|Nivolumab|-Specified dose on specified days
15998019|NCT02905266|Biological|Ipilimumab|-Specified dose on specified days
15998020|NCT02905253|Drug|AC-084|Hard gelatin capsules for oral administration formulated in strengths of 1 mg, 10 mg, and 100 mg
15998021|NCT02905253|Drug|Placebo|Placebo capsules matching AC-084 capsules
15998022|NCT02905240|Device|nSTRIDE APS|single intra-articular injection
15998023|NCT02905240|Device|Saline|single intra-articular injection
15998024|NCT02905227|Drug|CVT-427 (zolmitriptan inhalation powder)|Each subject received 2 self-administered doses of 3.0 mg CVT-427 (zolmitriptan inhalation powder), 2 hours apart.
15998025|NCT02905214|Device|stenting with the Coroflex ISAR sirolimus-eluting stent|coronary stenting
15998026|NCT02905188|Genetic|GLYCAR T cells|"Five different dosing schedules will be evaluated. Three to six patients will be evaluated on each dosing schedule.
~The following dose levels will be evaluated:
~DL1: 1x10^7/m2
~DL2: 3x10^7/m2
~DL3: 1x10^8/m2
~DL4: 3x10^8/m2
~DL5: 1x10^9/m2
~If DLTs are observed on DL1, patients will be enrolled on DL0 at 3x10^6/m2 dose.
~The first patient on each dose level has to be 14 days post T-cell infusion before the second patient can be enrolled.
~The doses are calculated according to the actual number of GPC3-CAR transduced T cells."
15998027|NCT02905188|Drug|Cytoxan|Cyclophosphamide will be given at a dose of 500 mg/m2/day for 3 days given intravenously
15998028|NCT02905188|Drug|Fludarabine|Fludarabine will be given at a dose of 30 mg/m2/day for 3 days given intravenously
15998029|NCT02905175|Procedure|blood sample|
15998030|NCT02905175|Procedure|synovial tissue|synoviocytes from synovial tissue
15998031|NCT02905162|Other|Transitional HIV care for prison releasees|Transitional HIV care program for releasees
15998032|NCT02905149|Procedure|Serrato|Serratus plane block.
15998033|NCT02905149|Procedure|Control|Standard anesthesia
15998034|NCT02905136|Other|Fundamental research|serum, whole blood, cerebrospinal fluid
15998035|NCT02905123|Behavioral|Check Your Drinking|
15998039|NCT02905097|Procedure|Knee Replacement|Surgical replacement of arthritic knee with an implant
15998040|NCT02905071|Other|filling of Serenat at baseline (T1)|Patients who consult occupational doctor complete the serenat questionnaire.The time taken to complete the serenat scale is about 5 minutes.
15998041|NCT02905071|Other|Serenat at baseline T1 and 3 others questionnaires|Subjects who consult occupational doctor complete the 4 questionnaires.The time taken to complete the 4 questionnaires is about 15 minutes.
15998042|NCT02905071|Other|filling of Serenat, HADS, STAY-Y and BDI at baseline T1|Patients who consult a psychiatrist in a stress anxiety unit complete the 4 questionnaires.
15998043|NCT02905058|Drug|Ketoprofen|oral non-steroidal antiinflammatory drug
15998044|NCT02905058|Drug|placebo|
15998045|NCT02905045|Drug|Ketoprofen|
15998046|NCT02905045|Drug|placebo|
15998047|NCT02905032|Behavioral|Decision Aid|Observation of clinical encounter using the electronic decision aid to facilitate treatment option conversation between clinician and patient.
15998048|NCT02905019|Biological|R21 with Matrix-M1|Vaccine
15998049|NCT02905019|Biological|ChAd63 ME-TRAP|Vaccine
15998050|NCT02905019|Biological|MVA ME-TRAP|Vaccine
15998051|NCT02905006|Drug|Bimekizumab|Subjects will be randomized to receive a combination of injections of Bimekizumab.
15998052|NCT02905006|Other|Placebo|Subjects randomized to the placebo group, will receive a combination of several injections of Placebo to maintain the blinding.
15998053|NCT02904993|Other|L2 paravertebral block|nerve block group will receive preoperatively a L2 paravertebral block with indwelling catheter
15998054|NCT02904993|Other|periarticular injection group|periarticular injection group will receive the injection cocktail towards the end of the total hip replacement prior to skin closure.
15998055|NCT02904980|Behavioral|Technical Training|Children will watch an instructional video focused on movement related instructions regarding the throwing and catching task.
15998056|NCT02904980|Behavioral|Quiet Eye Training|Children will watch the same video as the TT group but will also receive instructions designed to optimise their quiet eye durations.
15998057|NCT02904967|Biological|Extra Blood Draw|
15998058|NCT02904954|Drug|Durvalumab|Intravenously
15998059|NCT02904954|Other|Durvalumab plus SBRT|Intravenously
15998060|NCT02904941|Biological|Amniotic Membrane Dressing|Amniotic membrane dressings will be made out of donated amniotic membranes from elective cesarean sections. Screening for relevant infectious diseases and irradiation will be performed from every included sample in order to minimise infectious risks. Dressings will be provided to attending surgeons during wound care at the operating theatre and removed every 72-96 hours.
15998061|NCT02904941|Device|Synthetic Dressing|Silicone dressings will used as an active comparator in this study. As with the amniotic membrane, dressings will be applied to wound care at the operating room and replaced every 72 to 96 hours.
15998062|NCT02904941|Procedure|Standard Wound Care|Every included participant will receive standard wound care regardless of treatment allocation. Contaminants such as clothes or other materials will be removed, and all burns will be cleaned using sterile saline solutions. Clorhexidine will also be used to clean the skin. Surgical debridement under general anesthesia or procedural sedation/analgesia will be performed to every included participant, in which nonviable tissues and blisters will be removed.
15998063|NCT02904915|Drug|Lidocaine|Intrauterine device (IUD) placement with paracervical block with 1% lidocaine.
15998064|NCT02904915|Other|No analgesia|IUD placement without analgesia.
15998065|NCT02904915|Device|Intrauterine device (IUD)|IUD placement with or without paracervical block with 1% lidocaine.
15998066|NCT02904902|Drug|adalimumab|Subcutaneous Injection
15998067|NCT02904889|Behavioral|Stay Active at Home|Stay Active at Home' aims to change the behaviour of community nurses and domestic support workers by offering them an intensive training programme. Subsequently, professionals are expected to deliver goal-oriented, holistic and person-centred services focusing on supporting older adults to maintain, gain or restore their competences to engage in physical and daily activities so that they can manage their everyday life as independently as possible.
15998068|NCT02904889|Other|Usual care|Homecare professionals will get no training and their clients will receive usual homecare.
15998069|NCT02904876|Radiation|Diffusion Magnetic Resonance Imaging at 6 months|2-year follow-up MRI of patients initiating treatment with Tysabri with anti-JCV antibody positive or negative. Patients enrolled will benefit from diffusion MRI at 6 months, in addition to conventional MRI.
15998070|NCT02904863|Biological|Extra blood draw samples|
15998071|NCT02904850|Biological|group of patients|Plasma dosage of erlotinib and OSI-420 is made from the blood usually taken Further information are collected in the medical record of the patient during the CT scan reassessment after collection.
15998072|NCT02904837|Behavioral|Experimental training|"Each block of MP consists of 5 mental walking attempts with 10 imagined steps. Participants, seated comfortably, eyes closed, will be asked to imagine themselves walking as of a first-person perspective, without any overt physical movement, in four different conditions: habitual speed, as fast as possible, overcoming obstacles and memorizing a name of a specific medication.
~Each block of PP consists of 5 physical walking attempts, with 10 steps. Participants will be asked to walk in 4 different conditions: habitual speed,as fast as possible, overcoming obstacles and memorizing a name of a specific medication."
15998073|NCT02904837|Behavioral|Control training|"Each block of MP consists of 5 mental walking attempts with 10 imagined steps. Participants, seated comfortably, eyes closed, will be asked to imagine themselves seated appreciating a beautiful landscape as of a first-person perspective, without any overt physical movement, in four different contexts: in a carriage, in a hot air balloon, in a boat and in a zepelin.
~Each block of PP consists of 5 physical walking attempts, with 10 steps. Participants will be asked to walk in 4 different conditions: habitual speed,as fast as possible, overcoming obstacles and memorizing a name of a specific medication."
15998074|NCT02904824|Biological|adipose derived regenerative cells|Stem cells from autologous adipose tissue in which autologous tissue is enriched or in suspension to fill the paralyzed vocal cord. The aim is to induce the overexpression and production of microvessels at local level. Route of administration: injection into the thickness of a paralyzed vocal cord.
15998075|NCT02904824|Biological|centrifuged autologous fat|centrifuged adipose tissue which is autologous tissue is used to fill the paralyzed vocal cord. The aim is to increase the volume of the vocal fold, to reduce the glottal gap.This effect is temporary. Route of administration: injection into the thickness of a paralyzed vocal cord.
15998076|NCT02904811|Other|Testing for Ct infection immediately|Self-taken vaginal samples will be immediately tested for Ct infection at the National Reference Centre (CNR) at University of Bordeaux, using a commercially available CE marketed real-time PCR assay.
15998077|NCT02904811|Other|Testing for Ct infection at the end of the study|Self-taken vaginal samples will be tested for Ct infection at the end of the study (M18).
15998078|NCT02904798|Drug|Polypodium Leucotomos|- PL 240mg to be taken by the patient for 28 days prior to irradiation with visible light
15998079|NCT02904785|Device|Extracorporeal Shock Waves|
15998080|NCT02904785|Device|Sham Extracorporeal Shock Waves|
15998081|NCT02904785|Other|Physical activities|Patients receive instructions for physical activities for strengthening of femoral quadriceps and stretching of hamstring muscles.
15998082|NCT02904772|Drug|alipogene tiparvovec|A dose of 1x10(*12) gc/kg alipogene tiparvovec (Glybera) of body weight administered as a single set of intramuscular injections at multiple sites in multiple muscles of both upper legs and if necessary, the lower legs.
15998083|NCT02904772|Drug|Prednisolone|IV bolus methylprednisolone 1mg/kg half hour prior to administration
15998084|NCT02904772|Drug|Cyclosporins|Immuno + group will receive cyclosporine (3 mg/kg/day) from three days prior to until 12 weeks following IMP administration
15998085|NCT02904772|Drug|Mycophenolate mofetil|Immuno + group will receive Mycophenolate mofetil (2x 1 g/day) from three days prior to until 12 weeks following IMP administration
15998086|NCT02904759|Drug|Desmopressin|
15998087|NCT02904759|Drug|Placebo|
15998088|NCT02904746|Behavioral|Make It!|The Make It! motivational enhancement intervention has been informed by Motivational Interviewing principles, a method that has widely demonstrated effectiveness in increasing a number of positive behavior changes, including appointment adherence. Make It! consists of a 10-15 minute intervention with 5 components: Common reactions to stressors that this exposure can lead to a range of reactions, pros and cons of attending the Information Class, visualization of the Information Class, expression of confidence that the client can progress towards change, and reiteration of main information.
15998089|NCT02904733|Other|mHealth platform|Use of a mHealth platform to inform and empower patient of hies/her own health
15998090|NCT02904707|Other|Questionary EQ-5D|In addition to the pain questionary that is filled filled as usual, the EQ-5D questionary will be distributed at the beginning of hospitalization and completed by each patient, and will evaluate the impact of painful ulcers in their daily lives.
15998091|NCT02904681|Other|No intervention. Observational and descriptive study|
15998174|NCT02903836|Drug|Nafithromycin 800 mg 3 days|
15998175|NCT02903836|Drug|Nafithromycin 800 mg 5 days|
15998176|NCT02903836|Drug|Moxifloxacin 400 mg|
15998267|NCT02903082|Biological|Residue of blood further to preoperative workup|
15998092|NCT02904668|Other|self-managmeent program|One session was a session supervised by a physical therapist in the Faculty of Health Sciences. The program contents were educative information about chronic neck pain and healthy lifestyle habits (application of local heat/cold, and sleeping face down, using correct sitting posture, alternating body position, and using correct lifting technique (…), which were complemented by a problem-based session.
15998093|NCT02904655|Other|healthy diet|Participants were provided meals and snacks for one month that represented a healthy diet that is high in unsaturated fats, approximating a Mediterranean diet
15998094|NCT02904642|Behavioral|SMS reminder|Caregivers will receive two text message reminders for their child's measles immunization scheduled for 9 months of age
15998095|NCT02904642|Behavioral|Unconditional Incentive|A mobile-money incentive in the amount of 150 Kenyan Shillings will be transferred to the enrolled caregiver's mobile phone when the child reaches nine months of age
15998096|NCT02904629|Behavioral|Respecting the Circle of Life (RCL)|"Intervention activities will consist of the delivery of RCL: an holistic sexual, reproductive health and teen pregnancy prevention curriculum. RCL was adapted in 2011 from an evidence-based intervention (EBI) for the prevention of HIV/AIDS called Focus on Youth (FOY) + Informed Parents and Children Together (ImPACT)."
15998097|NCT02904629|Other|Control Program|Control activities will consist of the delivery of educational lessons on nutrition, fitness, outdoor recreation, safety, environmental protection and nature.
15998098|NCT02904616|Device|mobile spectrofluorimeter|
15998099|NCT02904577|Other|Any treatment, watch and wait policy included|"Patients registered in the study despite their planned treatment, watch and wait policy included. The planned treatment mentioned in the protocol is just the ideal approach proposed by investigators.The treatment can change depending on the evolution of the disease, without this affects the study's purposes."
15998100|NCT02904564|Drug|MMP with 5-FU|MMP with 5-FU using tattoo device
15998101|NCT02904564|Drug|MMP with Saline infusion|MMP with saline infusion using tattoo device
15998102|NCT02904551|Procedure|Free gingival graft|After infiltration anesthesia, a recipient bed was prepared with a horizontal split-thickness incision made with a 15 stainless steel blade at the mucogingival junction (MGJ) on the facial side of the selected implants. An intermediate thickness (0.75 mm) graft was taken from the palate. The graft was sutured with 6-0 polypropylene suture at the recipient site. Co-Pak® was applied on the recipient site. Analgesics (over-the-counter Tylenol or Ibuprofen) were prescribed for 5-7 days. PeridexTM (3M, St. Paul, MN) was prescribed for 7-10 days. No antibiotics were prescribed in relation to the surgery.
15998103|NCT02904551|Procedure|Oral prophylaxis|Oral prophylaxis is a regular dental cleaning. Titanium periodontal curette and superfloss were used on implant sites. Stainless steel periodontal curettes and a piezo scaler were used for natural teeth.
15998104|NCT02904538|Drug|Dexamethasone|
15998105|NCT02904538|Drug|isotonic saline|
15998106|NCT02904525|Device|7 Tesla MRI, no contrast agent|Patients with newly diagnosed glioblastoma undergo a 7Tesla MRI
15998107|NCT02904512|Device|Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose|Testing Blood Glucose levels with Continuous glucose Monitoring (CGM) device and Point of Care (POC) blood glucose
15998108|NCT02904512|Other|Point of Care (POC) blood glucose|Testing Blood Glucose levels with Point of Care (POC) blood glucose
15998109|NCT02904499|Drug|Dabigatran|
15998110|NCT02904486|Behavioral|change behavior|Modified Health Belief Model Based Intervention to Reduce Body Mass Index for Age
15998111|NCT02904473|Other|GROWell|The GROWell intervention is a mobile health technology, including diet tracking, skills training and tailored feedback based on digital and human support strategies. Its message content is geared toward healthy diet change during pregnancy.
15998112|NCT02904447|Other|x-ray and pedobar foot pressure mapping|
15998113|NCT02904434|Other|Grapefruit Juice|On day 1 of the study, subjects will receive their standard voriconazole dose with no grapefruit juice. On day 2 of the study, subjects will receive approximately 240mL of reconstituted grapefruit juice by mouth or via nasogastric tube 30 minutes prior to receiving a scheduled dose of voriconazole. Blood samples will be collected during the 12 hours following voriconazole dosing on both days of the study.
15998114|NCT02904408|Behavioral|psychotherapy|Group psychotherapy
15998115|NCT02904395|Other|observational (no intervention)|
15998116|NCT02904369|Drug|Emtricitabine|
15998117|NCT02904369|Drug|Tenofovir alafenamide|
15998118|NCT02904369|Drug|Tenofovir disoproxil|
15998119|NCT02904356|Device|Repetitive transcranial magnetic stimulation|High-frequency, brainsway H-coil for repetitive transcranial magnetic stimulation will be administered to the medial prefrontal cortex for 3 weeks. The intensity of stimulation will be based on resting-motor threshold (RMT).
15998120|NCT02904343|Device|domestic hemodialysis machine|WEGO, DBB-27C
15998121|NCT02904343|Device|imported hemodialysis machine|Fresenius, 4008s
15998122|NCT02904330|Drug|K1-70 intramuscular or K1-70 intravenous|Each subject will receive one dose of K1-70 by IM injection or one dose of K1-70 by IV infusion on the morning of Day 1.
15998123|NCT02904304|Drug|Desloratadine+Phenylephrine+Ibuprofen|01 tablet, orally, every 12 hours.
15998124|NCT02904304|Drug|Placebo|01 tablet, orally, every 12 hours.
15998125|NCT02904291|Drug|Amlodipine|Patients are tested for their normal prescription amlodipine medication
15998126|NCT02904278|Other|Teen Pocket PATH® Mobile Application|Participants in the intervention group will receive the mobile application for improving adherence to their post-transplant medications. The intervention will prompt, remind, and warn participants when medications are due, inform parents when medication management is completed, and engage parents when no action is undertaken.
15998127|NCT02904278|Other|Control Group: Standard of Care|Adolescents and parents/guardians assigned to the Standard Care Condition will receive standard clinical care per standard site procedures.
15998128|NCT02904265|Drug|Diazepam|
15998129|NCT02904265|Drug|Acetazolamide|
15998169|NCT02903862|Behavioral|Mindoula|The Mindoula intervention is a combination of case management and a messenger application. Case managers monitor how the participant is doing and any needs and provide 24/7 support & assistance, including care coordination, treatment adherence, and matching the participant with providers and community resources. Each participant will be given an intake questionnaire to establish goals and behavioral health history. Participants will use the app and work with the case manager for 12 weeks.
15998130|NCT02904252|Other|Transient elastography|Transient elastography (TE) is an ultrasound-based device used for measuring the degree of liver stiffness. A transducer probe is used to create mild amplitude and low frequency vibrations (50 Hz) that transmitted through the liver tissue. This results in an elastic shear wave that propagates through the underlying liver tissue. The probe then utilizes pulse-echo ultrasound to follow the propagation of the shear wave and to measure its velocity. The velocity of the wave is directly related to tissue stiffness which correlates with fibrosis. The sensitivity and the specificity of TE is between 68%-88% and between 66%-100%, respectively for the detection of significant liver fibrosis (METAVIR score F>2).
15998131|NCT02904226|Drug|JTX-2011|Specified dose on specified days
15998132|NCT02904226|Drug|Nivolumab|Specified dose on specified days
15998133|NCT02904226|Drug|Ipilimumab|Specified dose on specified days
15998134|NCT02904226|Drug|Pembrolizumab|Specified dose on specified days
15998135|NCT02904213|Biological|ComBe Five (Liquid)|
15998136|NCT02904200|Device|Silicon adhesive dressing|Sterile soft silicon adhesive dressing
15998137|NCT02904200|Device|Acrylic adhesive dressing|Sterile acrylic adhesive dressing
15998138|NCT02904187|Other|Positron Emission Tomography (PET)|
15998139|NCT02904187|Other|Electroencephalogram (EEG)|
15998140|NCT02904174|Behavioral|Healthy Living Programme|A 6-week Healthy Living Program (HLP) was developed and implemented for all the participants. There was one 45 minutes weekly session over 6 week. Week 1 & 2 focused on healthy eating habits including food pyramid, balanced diet for the elderly, food labels, healthy snacks and healthy eating out. Week 3 & 4 were about fall prevention, which included risk factors and complications of fall among older adults, preventive measures, strengthening exercises and aerobic dance. Week 5 & 6 focused on drug management, such as knowledge on commonly used drugs, drug storage, use of analgesics and non-pharmacological pain relief strategies. Interactive activities such as games, puzzles and question & answer session were included in the group education.
15998141|NCT02904148|Procedure|Shoulder mobilisation|early shoulder mobilisation
15998142|NCT02904122|Other|teleconsultation|Determine the interest of teleconsultation in dentistry tool for the diagnosis of caries. Ie whether oral teleconsultations are of the same quality as conventional consultations for the diagnosis of caries ..
15998143|NCT02904109|Drug|Triflusal|Once daily oral administration of 600 mg triflusal Disgren® for 8 days.
15998144|NCT02904109|Drug|Placebo|Once daily oral administration of placebo mannitol for 8 days.
15998145|NCT02904096|Device|Radiesse injectable implant and 2% lidocaine HCL|Radiesse injectable implant injected in small boluses (0.2-0.5cc/bolus). No more than 0.5cc per bolus. No more than 3 cc (2 syringes) will be injected per hand.
15998146|NCT02904083|Behavioral|self assessment of adherence|
15998147|NCT02904070|Device|Vaginal swabbing|
15998148|NCT02904057|Device|Radiesse (+) Injectable Implant|Treated subjects will receive a maximum volume of 3.0 cc of Radiesse (+) per jawline.
15998149|NCT02904031|Drug|5-fluorouracil|
15998150|NCT02904031|Drug|oxaliplatin|
15998151|NCT02904031|Drug|l-leucovorin|
15998152|NCT02904031|Drug|panitumumab|
15998153|NCT02904018|Other|teleconsultation|Patients performing oral care required as a result of their diagnosis by teleconsultation in vulnerable populations (elderly, disabled adults).
15998154|NCT02904005|Other|Standardized assessment on depressed patients|"At inclusion, socio-demographic characteristics, main life events, psychopathology (comorbidity, personality dimensions, characterisation of SB) and biological sample will be performed by psychiatrist and nurse. Investigators will retrieve the results of biological assays routinely made as part of standard collect biological results routinely done for all depressed patient.
~At follow-up (3 months, 6 months, 12 months), they will assess thymic state, occurrence of suicidal ideation and suicide attempt and environmental stressors. In case of non response, the general physician or the psychiatrist in charge of the patient will be contacted to assess the occurrence of SB during the year. In case of death or absence of clinical information, a request for cause of death certificate will be carried out through tne National Institute of Health and Medical research (INSERM) Unit 1018 / Epidemiological center on medical causes of death (CépiDc)."
15998156|NCT02903979|Other|HVGIC|In experimental group, the researches will be performed a restoration, after partial caries removal, with high viscosity glass ionomer cement in the teeth with deep caries lesion.
15998157|NCT02903979|Other|Indirect pulp capping|In control group, the researches will be performed a indirect pulp capping with calcium hydroxide cement and high viscosity glass ionomer cement in the teeth with deep caries lesion.
15998158|NCT02903966|Drug|GSK2982772|GSK2982772 is available as a 30 mg white to almost white, round film coated tablet which will be administered as two tablets three times a day as directed.
15998159|NCT02903966|Drug|Placebo|Placebo is available as a white to almost white, round film coated tablet which will be administered as two tablets three times a day as directed.
15998160|NCT02903940|Device|CRT+NAVH|Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis
15998161|NCT02903927|Device|Implantation of CT LUCIA IOL|
15998162|NCT02903927|Device|Implantation of Acrysof IQ SN60WF IOL|
15998165|NCT02903901|Drug|Melatonin|10 mg liquid Melatonin IR-SL at 7 pm for 1 week
15998166|NCT02903901|Drug|Placebo|10 mg liquid placebo at 7 pm for 1 week
15998167|NCT02903888|Drug|Levonorgestrel (Jaydess, Skyla, BAY86-5028)|Intrauterine delivery system Jaydess (13.5 mg levonorgestrel)
15998168|NCT02903875|Other|Patient therapeutic education (PTE) programme|
15998170|NCT02903862|Device|DANA|DANA is an FDA-cleared neurocognitive assessment software administered on a smartphone or tablet to measure changes in cognitive efficiency. DANA also includes Ecological Momentary Assessments to track mood, sleep, stress, and memory. Intervention participants will take DANA weekly. The Waitlist Control arm will take DANA weekly 12 weeks after enrollment.
15998177|NCT02903823|Drug|Baclofen bolus injection|A baclofen bolus injection (50 micrograms) will be administered daily after the patient returns from radiology to position catheter injection location. The injection may be given at C4, T4, T10 or L2 spinal locations depending on the catheter tip location.
15998178|NCT02903810|Biological|Mixed CAR-T Transfer|All subjects will be infused with αCD19-TCRz-41BB and αCD22-TCRz-41BB CAR-T cells in equal number
15998179|NCT02903784|Device|fMRI|Patient with grade 2 glioma and healthy volunteers use a brain imaging (fMRI)
15998180|NCT02903784|Procedure|tractography|Patient with grade 2 glioma and healthy volunteers use a brain imaging (tractography)
15998181|NCT02903784|Other|neuropsychological examination|Patient with grade 2 glioma and healthy volunteers use a neuropsychological examination
15998182|NCT02903771|Drug|Part A: Dose Escalation of Cantrixil|"Cantrixil will be administered via the intraperitoneal route only. The dose of study drug that each participant will receive will depend on how far the study has progressed when the participant enrols. There are 9 potential doses of Cantrixil, they are 0.06, 0.12, 0.24 (starting dose), 0.6, 1.25, 2.5, 5, 10, or 20 mg/kg. The dose each participant receives will remain the same during the study, unless it needs to be reduced for safety reasons. The dose will not be increased.
~Each participant will receive the study drug once a week during the first two cycles; each cycle is 21-days (three weeks); the MTD will be determined during Cycle 1 only. If after two cycles of monotherapy, the patient tolerates Cantrixil adequately, they may continue to receive Cantrixil once a week and will also begin combination chemotherapy for another 6 cycles. Participants will receive no more than 8 cycles of study drug."
15998183|NCT02903771|Drug|Part B: Expansion Cohort of Cantrixil|Once the MTD has been established, an expansion cohort will be recruited at the MTD. An additional 12 patients will be recruited in this cohort on top of those recruited in Part A at the MTD. These patients will be subjected to the same intervention described in Part A with 2 cycles of monotherapy followed by up to 6 cycles of combination therapy.
15998184|NCT02903758|Other|cross sectional|
15998185|NCT02903745|Other|observational|
15998186|NCT02903732|Other|observational|registry
15998187|NCT02903719|Drug|Ropivacaine|All included patients with a right sided shoulder pain score on a numeric rating scale (NRS) equal to or above 6 and without postoperative exclusion criteria will have two (1st and 2nd intervention) ultrasound guided phrenic nerve blocks performed.
15998188|NCT02903706|Other|Measure of Plasmodium prevalence (PCR)|
15998189|NCT02903693|Other|cross sectional|
15998190|NCT02903680|Drug|Dexamethasone group|The intervention of interest was the administration of dexamethasone 0.6 mg/kg IV (max 15 mg) before departure from the ED. The control group received a similar looking placebo (NaCl 0,9% IV) with the same volume.
15998191|NCT02903680|Drug|Placebo group|Normal Saline 0,9% same volume
15998192|NCT02903667|Device|Bone grafting|
15998193|NCT02903654|Other|observational|
15998194|NCT02903641|Behavioral|Personalized information|"During a prior study in June-July 2016, we collected anthropometric measures on the index children, including the children's height. Based on these data, for households assigned to the information treatment, enumerators provided personalized information to the children's primary caregiver about the index child's current height, during a baseline household visit. The enumerators carried a display card that visually showed where the child's height fell compared to healthy children of the same age and gender like those in East Africa. The enumerators emphasized to the caregivers that short stature is due to poor chronic malnutrition and is not just attributable to genetics or a recent illness. During this visit, the enumerators additionally pointed out that chronic malnutrition is not immediately life-threatening."
15998195|NCT02903641|Behavioral|Labeled cash transfer|Households received a cash transfer labeled for child food consumption and were told the money is designed to cover additional spending for food for the index child (and any other younger children in the household) over the next six weeks. Though it was given as a single, lump sum payment, the transfer was evenly split and handed to the household in six sealed envelopes, to help the households better allocate the money. To further encourage them not to spend the money all at once, each envelope was labeled with a number, the index child's name, and the dates for the week the money in the envelope should be spent. Enumerators clearly stated that this is a one-time money transfer.
15998196|NCT02903628|Behavioral|eye health education|give a lecture and issue knowledge manual for children and parents ,6 months once , 2.5 years
15998197|NCT02903615|Other|Novel diet|Novel diet to optimise glucose levels and minimise systemic inflammation: altered macronutrient composition: lower carbohydrate, Mediterranean-style, prebiotic fibre focus.
15998198|NCT02903615|Other|Standard diet|Standard diabetes diet recommendations
15998199|NCT02903602|Behavioral|Sharing Histories training method for CHW|Female Community Health Worker training participants were led through a guided process of recalling and sharing their autobiographical memories of their personal experiences in the first 1000 days of each of their children (pregnancy, childbirth, postpartum, newborn, breastfeeding, complementary feeding, infant diarrhea and hygiene, pneumonia). On the basis of memories, cultural beliefs and practices are identified and training content is built.
15998200|NCT02903602|Behavioral|Standard training method for CHW|Female Community Health Workers were trained with standard participatory teaching method with three phases: identify knowledge, provide new knowledge, evaluate learning.
15998201|NCT02903589|Other|observational|
15998202|NCT02903576|Procedure|injection of hESC-RPE in suspension|The first six patients will receive a sub retinal injection of hESC-RPE in solution after a complete pars plana vitrectomy to access safety of the cell implant alone.
15998203|NCT02903576|Procedure|injection hESC-RPE seeded in a substrate|Fifteen patients will receive a sub-retinal implantation of embryonic stem cell derived retinal pigmented epithelium seeded in a polymeric substrate to access safety of substrate seeded with RPE
15998204|NCT02903563|Other|observational|
15998205|NCT02903537|Drug|Autologous VitD3 tolerogenic monocyte-derived dendritic cells loaded with a pool of myelin peptides (tolDC-VitD3)|Intranodal administration
15998206|NCT02903537|Drug|Interferon-beta|Subcutaneous administration interferon-beta
15998207|NCT02903524|Drug|Doxorubicin Hydrochloride Liposome injection and cyclophosphamide|
15998208|NCT02903524|Drug|pirarubicin and cyclophosphamide|
15998209|NCT02903511|Drug|Metformin|Monitoring of safety and tolerability
15998210|NCT02903511|Drug|Placebo|Monitoring of safety and tolerability
16061592|NCT02443688|Drug|Placebo|
15998213|NCT02903485|Other|the anesthetic team performs presurgical assessement and surveillance during surgery|
15998214|NCT02903459|Other|Transversal Study so there is no intervention|
15998215|NCT02903446|Drug|Denosumab|Participants will be randomized (1:1) allocation to denosumab 60 mg administered subcutaneously (SC) every 6 months for a year + ULT standard of care OR ULT standard of care therapy
15998216|NCT02903433|Other|High-intake avocados|Families will receive 14 avocados on a weekly basis.
15998217|NCT02903433|Other|Low-intake avocados|Families will receive 3 avocados on a weekly basis.
15998218|NCT02903433|Behavioral|Diet tips|Diet tips will come from educational materials including culturally appropriate dietary and nutritional education materials, and personalized recommendations taken from http://www.choosemyplate.gov.
15998219|NCT02903433|Behavioral|Avocado consumption advice|Recipe book with healthy recipe suggestions that include avocado.
15998220|NCT02903420|Device|Transcatheter Aortic Valve Implantation (TAVI)|Implantation of Edwards SAPIEN 3 Transcatheter Heart Valve (Model: 9600TFX) via transfemoral, transapical or transaortic approach.
15998221|NCT02903407|Drug|Midazolam|IV midazolam will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
15998222|NCT02903407|Drug|Propofol|IV propofol will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
15998223|NCT02903407|Drug|Dexmedetomidine|IV dexmedetomidine will be administered as a continuous infusion to maintain set goal sedation level of RASS 0 to -2.
15998224|NCT02903394|Device|mLCI Device|imaging of cervical epithelium using mLCI device
15998225|NCT02903381|Drug|Nivolumab|Intravenous, predetermined dosage, Days 1 and 15 during cycles 1-12 and
15998226|NCT02903381|Drug|Lenalidomide|Oral, predetermined dosage, Days 1-21 of cycle 1-12
15998227|NCT02903381|Drug|Dexamethasone|Oral, Days 1, 8, 15 of cycle 1-6
15998228|NCT02903368|Drug|Apalutamide|
15998229|NCT02903368|Drug|Leuprolide|
15998230|NCT02903368|Drug|Prednisone|
15998231|NCT02903368|Drug|Abiraterone Acetate|
15998232|NCT02903355|Drug|D-methionine|D-methionine, oral liquid suspension
15998233|NCT02903355|Drug|Placebo|Placebo contains sorbitol, orange flavor and purified water; is flavor and color matched to D-Met.
15998234|NCT02903342|Other|Leaflet|A leaflet designed from data obtained from previous qualitative and quantitative studies.
15998235|NCT02903329|Other|Detoxification|Two ways of composing the detoxification protocol
15998236|NCT02903316|Procedure|Fluids|
15998237|NCT02903303|Other|Hypnosis|"It will consist in 4 hypnosis sessions within 2 weeks mainly for analgesic purpose. The main themes are :
~1st session : contact with the therapist, body scan, basic suggestions
~2nd session : hypnosis induction followed by suggestions tu build a safe place
~3rd session : it is the first complete hypnosis session (induction and specific suggestions against pain)
~4th session : very similar to the previous session for the content, focused on auto-hypnosis learning."
15998238|NCT02903290|Other|Longitudinal Monitoring of Energy Expenditure, Dynamic Stability and Fatigue During Gait|
15998239|NCT02903290|Other|walking track GAITRite,manual dynamometer, and treadmill|
15998240|NCT02903264|Other|Gestational diabetes mellitus|
15998241|NCT02903251|Drug|intranasal oxytocin spray|6 insufflations (24 IU of oxytocin total) given twice daily, day 1-3. 2 insufflations (8 IU of oxytocin total) as needed, max thrice daily, day 3-30.
15998242|NCT02903251|Other|intranasal spray without oxytocin|6 insufflations (24 IU of placebo total) given twice daily, day 1-3. 2 insufflations (8 IU of placebo total) as needed, max thrice daily, day 3-30.
15998243|NCT02903238|Drug|Duloxetine|Duloxetine Delayed-Release Capsules: 30mg/day for 1 week ; 60mg/day for the remaining time
15998244|NCT02903238|Drug|Placebo Oral Tablet|Lactose capsule
15998245|NCT02903225|Behavioral|Cardiac Rehabilitation|All patients included in this group attended a supervised exercise training program. A cardiologist supervised the hole training sessions. Blood pressure, pulse rate, oxygen saturation, and body weight were measured in each session. The modified Borg scale was used to measure the perceived exercise intensity
15998246|NCT02903212|Biological|Autologous apoptotic cells injection|cells injection
15998247|NCT02903199|Dietary Supplement|Whey Protein|Whey protein (18 g) administered immediately prior to breakfast and lunch meals.
15998248|NCT02903199|Dietary Supplement|Hydrolysed Protein|Hydrolysed whey protein (19.1 g) administered immediately prior to breakfast and lunch meals.
15998249|NCT02903199|Dietary Supplement|Placebo|Placebo intervention administered immediately prior to breakfast and lunch meals.
15998250|NCT02903186|Behavioral|SMS|This is an intervention using short mobile messages (SMS)
15998251|NCT02903160|Drug|Abiraterone acetate|Abiraterone acetate 1000 mg PO daily
15998252|NCT02903160|Drug|Prednisone|5 mg PO twice a day
15998253|NCT02903160|Drug|Radium-223 dichloride|50 kBq/kg IV monthly
15998254|NCT02903160|Drug|cabazitaxel|25 mg/m2 IV every 3 weeks
15998255|NCT02903160|Drug|Carboplatin|Carboplatin AUC 4 IV every 3 weeks
15998256|NCT02903160|Drug|Enzalutamide|160 mg PO daily
15998257|NCT02903147|Behavioral|Functional Meta-Cognitive Intervention|Functional-Meta-Cognitive Intervention Program was focused on raising awareness to safe driving risk factors identified at pre-screening, with reference to the difficulties that the driver raises and providing coping strategies. The intervention has been customized for each driver and included three sessions of two hours.
15998258|NCT02903147|Behavioral|The employer's training|
15998259|NCT02903121|Drug|Tamoxifen|Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study
15998260|NCT02903121|Drug|Placebo|Placebo orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the first 90 days of the study
15998261|NCT02903121|Drug|Tamoxifen (open label)|Tamoxifen 10 mg orally twice daily for 7 days. Treatment to be started after 3 consecutive days of bleeding and can be repeated every 30 days two more times in the second 90 days of the study
15998262|NCT02903108|Drug|SRP plus boric acid gel|SRP followed by 0.75% boric acid placement into intrabony defect
15998263|NCT02903108|Drug|SRP plus placebo gel|SRP followed by placebo gel placement into intrabony defect
15998264|NCT02903095|Drug|TD-1439|
15998268|NCT02903082|Biological|Bone marrow collected during a myelogram carried out for hematological pathology workup|
15998269|NCT02903082|Biological|Bone marrow collected during myelogram routinely performed during hospitalization in ICU|
15998270|NCT02903069|Drug|MRZ|"MRZ dose ranges from 0.55 to 1.2 mg/m2 given IV over 10 minutes on Days 1, 8, 15, 29, and 36 during Concomitant Treatment.
~MRZ dose ranges from 0.55 to 1.2 mg/m2 given IV over 10 minutes on Days 1, 8, 15 every 28 days during Adjuvant Treatment.
~IV hydration will be given prior to the MRZ infusion."
15998271|NCT02903069|Drug|TMZ|"TMZ will be administered once daily, 7 days/week, for 6 weeks, starting on Day 1, at a dose of 75 mg/m2 during Concomitant Treatment.
~TMZ will be administered once daily on Days 1-5 every cycle, dose range 150 to 200 mg/m2 during Adjuvant Treatment."
15998272|NCT02903069|Radiation|RT|Focal RT will be administered once daily, 5 days/week, for 30 doses over 6 weeks to a total dose of 60 Gy, starting on Day 1 during Concomitant Treatment.
15998273|NCT02903069|Device|Optune|Tumor Treating Fields Therapy device to be worn ≥ 18 hours per day.
15998274|NCT02903056|Other|Rett Syndrome|Diagnosis of Rett Syndrome
15998275|NCT02903030|Drug|Maltose (placebo)|Maltose with a trace amount of silicon dioxide
15998276|NCT02903030|Drug|Visbiome Extra Strength|It is a mix of 8 strains of beneficial bacteria that should improve gut flora, improving GI function and hopefully anxiety
15998277|NCT02903017|Drug|Tranexamic acid 5%|Via nasogastric tube, 100 mL
15998278|NCT02903017|Drug|Placebo|Via nasogastric tube, 100 mL
15998279|NCT02903004|Drug|Trabectedin|
15998280|NCT02903004|Drug|Pegylated Liposomal Doxorubicin|
15998281|NCT02903004|Drug|Topotecan|
15998282|NCT02903004|Drug|Gemcitabine|
15998283|NCT02903004|Drug|Weekly Paclitaxel|
15998284|NCT02903004|Drug|Carboplatin|
15998285|NCT02902978|Drug|E6130|
15998286|NCT02902978|Drug|Placebo|E6130 matched placebo
15998287|NCT02902965|Drug|Ibrutinib|Ibrutinib 840 mg orally, once daily continuously starting day 1 of cycle 1 until confirmed disease progression, unacceptable toxicity or other protocol specified reason for discontinuation
15998288|NCT02902965|Drug|Bortezomib|Cycles 1-8: (21-day cycle): Bortezomib 1.3 mg/m^2 sub-cutaneously on days 1, 4, 8, and 11 of each Cycle Cycles 9-12: (42-day cycle): Bortezomib 1.3 mg/m^2 sub-cutaneously on days 1, 8, 22 and 29 of each Cycle
15998289|NCT02902965|Drug|Dexamethasone|"Cycles 1-8: (21-day cycle): Dexamethasone 20 mg orally on days 1, 2, 4, 5, 8, 9, 11 and 12 of each cycle Cycles 9-12: (42-day cycle): Dexamethasone 20 mg orally on days 1, 2, 8, 9, 22, 23, 29 and 30 of each cycle Cycles 13+ (28-day cycle): Dexamethasone 40 mg orally once weekly
~Dose adjustment of dexamethasone to 10 mg on days specified during cycles 1-12 and 20 mg weekly during cycles 13+ is recommended for subjects >75 years of age.
~Following implementation of Protocol Amendment 4, dexamethasone administration was reduced to Days 1, 4, 8 and 11 during each 21-day cycle (Cycles 1-8) and on Days 1, 8, 22, 29 on each 42-day cycle (Cycles 9-12) and unchanged thereafter."
15998290|NCT02902952|Behavioral|Physical Exercise|An eight week physical exercise intervention
15998291|NCT02902952|Behavioral|Control Intervention|An eight week sedentary control intervention
15998292|NCT02902939|Device|minimal extracorporeal circulation (MEC)|We should use the modification of extracorporeal circulation to reduce the systemic inflammatory response due to excessive haemodilution, allogenic blood transfusion.
15998293|NCT02902939|Procedure|The cytokines modulations|We should use the modification of cytokines by CytoSorb devices and cytokines removal by PMMA membranes during extracorporeal circulation in patients with risk factors of complications (long duration of extracorporeal circulation, re-do procedures and other)
15998294|NCT02902926|Behavioral|Low FODMAPs Diet|Instruct to design and eat Low Fermentable，Oligo-，Di-，Mono-saccharides And Polyols(FODMAPs) Diet
15998295|NCT02902926|Behavioral|Diet instruction|Answer the doubt and help the patient get the diet knowlege about the IBS.
15998296|NCT02902913|Other|D2i2|Oleocanthal provided in a 2:1 ratio compared to oleacein
15998297|NCT02902913|Other|D2i0.5|Oleocanthal provided in a 1:2 ratio compared to oleacein
15998298|NCT02902913|Other|D2i0|No oleocanthal and no oleacein
15998299|NCT02902913|Drug|Ibuprofen|400 mg of Ibuprofen
15998300|NCT02902887|Device|Controlled Intermittent Alternate Occlusion (CIAO ) glasses|Monitored CIAO therapy glasses
15998301|NCT02902874|Other|Blood sample|
15998302|NCT02902861|Drug|Methotrexate|methotrexate 50 mg/ml in syringes for sub-cutaneous injection; Once weekly (every 7 days) s.c. administration of 17.5 mg MTX; If PASI50 is not reached after 8 weeks, the dosing will be increased to 22.5 mg
15998303|NCT02902861|Drug|Placebo ( for Methotrexate)|NaCl-Solution manufactured to mimic Methotrexate
15998304|NCT02902835|Behavioral|BUP_FAST|Peer mentorship including: buprenorphine education, identifying buprenorphine providers, accompaniment at appointments, and psychosocial support (via outreach phone calls)
15998305|NCT02902835|Behavioral|Referral to treatment|Participants will receive a pamphlet describing the buprenorphine treatment program at a Montefiore community health center.
15998306|NCT02902822|Procedure|Screening|"The screening visit consists in a general dermatological examination of the subject, with special focus on the onset of the following skin diseases during the follow-up period:
~bacterial skin infections - pyoderma - or viral (erysipelas, impetigo, herpes zoster, molluscum contagiosum, viral warts);
~fungal skin infections (tinea corporis, cruris, pedis);
~pigmented tumors (melanoma);
~non-melanocytic tumors (actinic keratoses, basal cell or squamous cell carcinoma)."
15998307|NCT02902822|Device|Tele-dermatology|"The system consists in a simple web-based/smartphone application through which subjects can send pictures of recently onset non-widespread skin lesions with special focus on the following diseases:
~bacterial skin infections - pyoderma - or viral (erysipelas, impetigo, herpes zoster, molluscum contagiosum, viral warts);
~fungal skin infections (tinea corporis, cruris, pedis);
~pigmented tumors (melanoma);
~non-melanocytic tumors (actinic keratoses, basal cell or squamous cell carcinoma).
~A dermatology will judge online pictures based on a standard scale. Each subject who will use the system will be also seen by routine clinical visit to confirm the online diagnosis. Subjects who will not send any picture will be seen for a dermatological examination at the end of each year."
15998308|NCT02902809|Biological|Tralokinumab open-label|Subcutaneous injection; fixed dose; 300 mg
15998352|NCT02902445|Biological|rotavirus rapid screen test|According to routine care
16063407|NCT02429817|Device|Jet Nebulizer|
15998309|NCT02902796|Device|Spinal cord stimulator|Spinal cord stimulator will be programmed to deliver, according to the randomization status of the patient, burst, 1000 hertz, and standard stimulation during each treatment group.
15998310|NCT02902783|Other|Data Collection|Data collection relevant to this study will be obtained by observation and review of hospital charts. Limited data will be obtained through relevant organ donation organizations (ODOs).
15998311|NCT02902770|Drug|Lidocaine|1.5 mg/kg IV lidocaine drip (given over 10 minutes)
15998312|NCT02902770|Drug|Ketorolac Tromethamine|IV ketorolac 30mg push
15998313|NCT02902770|Drug|Normal Saline Drip|Normal Saline Drip Placebo given over 10 minutes
15998314|NCT02902770|Drug|Normal Saline Push|Normal Saline Push Placebo
15998315|NCT02902757|Procedure|Computed Tomography|Undergo FDG PET/CT
15998316|NCT02902757|Radiation|Fludeoxyglucose F-18|Undergo FDG PET/CT
15998317|NCT02902757|Procedure|Positron Emission Tomography|Undergo FDG PET/CT
15998318|NCT02902744|Drug|ILUVIEN®|Patients will receive Iluvien as the standard of care treatment for diabetic macular edema.
15998319|NCT02902731|Drug|PLACEBO|subcutaneous injection of placebo every day during 16 weeks
15998320|NCT02902731|Drug|ANAKINRA|subcutaneous injection of anakinra every day during 16 weeks
15998321|NCT02902718|Device|mē|The mē device will be used for self administered facial treatments that will be repeated up to 3 times every session. The duration of a treatment session is 5-10 minutes.
15998322|NCT02902705|Other|Biopsy of abdominal subcutaneous white adipose tissue (2-3 g)|The biopsies of abdominal subcutaneous white adipose tissue (2-3 g) will be performed during elective surgery (i.e. peritoneal dialysis catheter) for CDK patients or during elective urologic surgery (e.g. radical prostatectomy) for Non-CDK patients. 50-100 mg will fixed in osmium tetroxide for cellularity measurement and 1g of fresh adipose tissue were used from adipocyte isolation. The remnant part of the biopsies will be snap frozen in liquid nitrogen and stored at -80°C until use (gene expression).
15998323|NCT02902692|Other|Brief Mindfulness|15 minutes psycho-education about mindfulness and a small experiential exercise using a raisin. Following this, participants listen to a 30minute pre-recorded sitting meditation which encourages them to focus on their breath and the sounds around them. Participants will be randomly assigned to either receive the brief mindfulness intervention immediately or will be asked to wait one week before receiving the intervention.
15998324|NCT02902679|Drug|BMS-986177|
15998325|NCT02902666|Drug|Paracetamol 1000 mg/codeine phosphate hemihydrate 30 mg tablet|
15998326|NCT02902666|Drug|Paracetamol 500 mg/codeine phosphate hemihydrate 30 mg tablet|
15998327|NCT02902653|Drug|Oral misoprostol|hourly titrated misoprostol
15998328|NCT02902653|Drug|Vaginal misoprostol|Administration of 25 microgs every 6 hours, maximum 150 microgr
15998329|NCT02902653|Drug|Vaginal dinoprostone|Vaginal delivery system of 10mg of dinoprostone
15998330|NCT02902640|Drug|Guaifenesin|Guaifenesin will be administered as per treating physician's discretion, according to local labeling. The protocol does not specify any dose, frequency, and duration of treatment.
15998331|NCT02902640|Drug|Sulfamethoxazole|Sulfamethoxazole will be administered as per treating physician's discretion, according to local labeling. The protocol does not specify any dose, frequency, and duration of treatment.
15998332|NCT02902640|Drug|Trimethoprim|Trimethoprim will be administered as per treating physician's discretion, according to local labeling. The protocol does not specify any dose, frequency, and duration of treatment.
15998333|NCT02902627|Device|Non Invasive Monitoring Device (ANI)|Pain measure by ANI monitor and with visual analogical scale
15998334|NCT02902614|Procedure|Vegetal Pole blastomer embryo|for day 3 embryo biopsy / cleavage stage
15998335|NCT02902614|Procedure|Animal Pole blastomer embryo|for day 3 embryo biopsy / cleavage stage
15998336|NCT02902601|Drug|JNJ-54175446, 600 mg|Participants will receive JNJ-54175446, 600 mg as an oral suspension.
15998337|NCT02902601|Drug|JNJ-54175446, 150 mg|Participants will receive JNJ-54175446, 150 mg as an oral suspension.
15998338|NCT02902601|Other|Placebo|Matching placebo to JNJ-54175446
15998339|NCT02902588|Other|ICG-PULSION|Intravenous administration of indocyanine green
15998340|NCT02902588|Device|LiMON, Pulsion Medical Systems|Application of near infrared light
15998341|NCT02902588|Other|Gadolinium (Gadovist, Bayer, Germany)|Injection of gadolinium
15998342|NCT02902575|Procedure|Laparoscopic-assisted gastrectomy with D2 lymphadenectomy|After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic-assisted gastrectomy with D2 lymphadenectomy will be performed with curative treated intent.The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy
15998343|NCT02902562|Procedure|Contrast Enhanced Ultrasound (CEUS)|An intravenous line (IV) line will be inserted into a vein in your arm. You will be asked to lie on a table for the ultrasound imaging. First, a regular ultrasound (without contrast) will be performed and the images will be recorded. For the contrast enhanced ultrasound, the contrast agent will be injected into your IV line. We will perform another ultrasound and the images will be recorded
15998344|NCT02902562|Procedure|Magnetic Resonance Imaging (MRI)|For the contrast MRI, the contrast agent will be injected into your IV line The MRI scanner is a small, tunnel-like machine in which a patient will be required to lie still for a long period of time. There is little space inside the scanner, which causes anxiety and discomfort for patients who fear enclosed spaces. A technician will be present at all times during the examination to communicate with you about how you are feeling.
15998345|NCT02902536|Other|No interventions|
15998346|NCT02902523|Drug|Viread® tablet 300mg|Single dose administration(PO) in the fasted state
15998347|NCT02902523|Drug|HUG116 tablet 245mg|Single dose administration(PO) in the fasted state
15998348|NCT02902510|Other|Therapeutic yoga for people with Parkinson's Disease|Held for 8 weeks, individuals participated in therapeutic yoga 60 minutes 2x/week.
15998349|NCT02902484|Drug|Nintedanib|Nintedanib Monotherapy Followed by Combination Therapy of Nintedanib and Gemcitabine Plus nab-Paclitaxel
15998350|NCT02902471|Other|Forced oscillations measure|
15998351|NCT02902458|Other|Individual interview with a qualified psychologist|Individual, recorded interview with a qualified psychologist to discuss any and all subjects related to the ICD implantation, or any other topics deemed relevant by the patient.
15998353|NCT02902445|Genetic|polymorphism exploration|from an oral swab collected after parents consent
15998354|NCT02902432|Drug|Endostar|The patients will be randomized to CRT arm and CRT+Endostar arm. All patients will receive one cycles of induction chemotherapy, intensity modulated radiation therapy (IMRT) with weekly cisplatin and 3 cycles of chemotherapy after IMRT.
15998355|NCT02902419|Other|Wound dressing removal.|
15998356|NCT02902393|Biological|Thromboelastography|
15998357|NCT02902380|Drug|dexmedetomidine group|dexmedetomidine infusion (0.4 mcg/kg/h) from immediately after anesthetic induction to end of surgery
15998358|NCT02902380|Drug|control group|0.9% saline infusion
15998359|NCT02902367|Other|Outdoor walking and strength exercise|Exercise group: Participants are supposed to perform an outdoor walking exercise program and one strength exercise for 12 weeks. The first 2 weeks start with daily walks. The intensity and frequency of walks will progressively increase performed according to the Borg scale: 12-15, ie, moderate to strenuous. Participants will walk 5-7 days/week. Added to this is a strength exercise, i.e. chair-rising which also should be performed daily.
15998360|NCT02902367|Other|control group|Control-Group: Treatment as usual for 12 weeks, without restriction of being physically active.
15998361|NCT02902354|Other|Nifedipine for tocolysis|observational
15998362|NCT02902341|Dietary Supplement|Nutrition Therapy|Nutrition based on measured caloric needs.
15998363|NCT02902341|Dietary Supplement|Control|Standard protocol nutrition based on calculated caloric needs.
15998364|NCT02902315|Other|Cryotherapy|The intervention will consist of the application of hypothermia by immersion of the lower limbs of water on individuals to 15ºC for a period of 10 minutes immediately after the exercise protocol.
15998365|NCT02902315|Other|Vitamins C and E|The session of resistance exercises with intervention will be based on the supplementation with vitamin C (1000 mg) and vitamin E (800 IU) by oral intake (100mL of water) 40 minutes before basal blood collection.
15998366|NCT02902315|Other|Vitamins C and E associated with cryotherapy|The session of resistance exercises with intervention will be based on the supplementation with vitamin C (1000 mg) and vitamin E (800 IU) by oral intake (100mL of water) 40 minutes before basal blood collection. The intervention will consist of the application of hypothermia by immersion of the lower limbs of water on individuals to 15ºC for a period of 10 minutes immediately after the exercise protocol.
15998367|NCT02902315|Other|Placebo|The volunteers from placebo exercise session will receive two pills (containing wheat flour) and the remaining procedures were conserved.
15998368|NCT02902302|Drug|Ibuprofen 400 mg/10 mL oral suspension|
15998369|NCT02902302|Drug|MOMENT 400 mg coated tablet|
15998370|NCT02902289|Drug|Ibuprofen 200 mg/5 mL oral suspension|
15998371|NCT02902289|Drug|MOMENT 200 mg coated tablet|
15998372|NCT02902276|Other|additional blood sample|Two blood samples will be taken at ICU admission
15998373|NCT02902250|Procedure|Decompression|vertebral body decompression in compression fracture
15998374|NCT02902250|Procedure|vertebroplasty|vertebroplasty in vertebral compression fracture
15998375|NCT02902237|Biological|tTF-NGR|tTF-NGR will be given as 1-hour infusion via central venous access once daily for 5 days with a subsequent rest period of 2 weeks and following cycles with dose escalation of 0.5 mg/m2 upon judgement of tolerability and therapeutic activity. Starting dose will be 1 mg/m2/day. Dose-escalation is stopped before the maximum number of 8 escalation steps if tumor response, tumor progression or a Dose-Limiting Toxicity (DLT) is observed.
15998376|NCT02902224|Dietary Supplement|Tap water|300ml tap water via nasogastric tube
15998377|NCT02902224|Dietary Supplement|Glucose|300ml tap water with 75g glucose via nasogastric tube
15998378|NCT02902224|Dietary Supplement|Fructose|300ml tap water with 25g fructose via nasogastric tube
15998379|NCT02902211|Device|Ankle foot orthosis|Patients will wear an ankle foot orthosis at all times except when he/she is sleeping or bathing for three months.
15998380|NCT02902211|Other|Control/standard of care|Patients will carry out with typical activities suggested by their physician for three months.
15998381|NCT02902198|Dietary Supplement|Placebo|Tap water 200ml
15998382|NCT02902198|Dietary Supplement|Glucose|25g Glucose in 200ml tap water
15998383|NCT02902198|Dietary Supplement|Monosodium glutamate|1g monosodium glutamate in 200ml tap water
15998384|NCT02902198|Dietary Supplement|Quinine|17mg quinine in 200ml tap water
15998385|NCT02902185|Drug|ART plus Chidamide|Chidamide will be administrated 10mg each time, twice a week, interval not less than 3 days for 12 weeks.Antiretroviral therapy will be kept during entire study.
15998386|NCT02902185|Drug|ART plus Placebo|Placebo will be administrated 10mg each time, twice a week, interval not less than 3 days for 12 weeks.Antiretroviral therapy will be kept during entire study.
15998387|NCT02902172|Drug|Acetaminophen|Blood pressure will be monitored during postpartum stay (typical 2 days) and then again at 1 week and 6 weeks (standard practice of care) with blood pressure measurements
15998388|NCT02902172|Drug|NSAID|Blood pressure will be monitored during postpartum stay (typical 2 days) and then again at 1 week and 6 weeks (standard practice of care) with blood pressure measurements
15998389|NCT02902159|Other|BWW Online Peer Support|Free access to BWW online peer support and other services offered by them (except live therapy), for 6 months.
15998390|NCT02902159|Other|NHS Moodzone Online Information|Directed to access to online information from NHS Moodzone
15998391|NCT02902146|Device|Bougie|
15998392|NCT02902146|Device|Endotracheal tube|
15998393|NCT02902133|Drug|Acetazolamide|Acetazolamide 500 mg by mouth twice per day for 5 days
15998394|NCT02902120|Drug|Post-transplant Grazoprevir and Elbasvir|Treatment will be started in the post-transplant patients on day 0 with the combination pill zepatier, containing grazoprevir 100mg/elbasvir 50mg by mouth once daily. The medications will be continued for a total of 12 weeks (16 weeks if resistance mutations, RAVs, are detected)
15998398|NCT02902094|Device|Drug eluting balloons|
15998399|NCT02902094|Device|Non drug eluting balloons|
15998400|NCT02902081|Drug|Cannabidiol|
15998401|NCT02902081|Drug|Placebo|
15998435|NCT02901730|Procedure|561nm laser group|LPI with 561nm laser.
15998402|NCT02902068|Device|NICaS Bio Impedance|"Hemodynamic monitoring will be carried out using non invasive NICaS cardiac impedance by the use of two electrodes stickers which are pasted on the wrists for about 6 minutes.
~Monitoring will be done with women lying down or sitting up half an hour preoperatively (in the woman's surgery waiting room) intraoperatively, and postoperatively in the PACU.
~Preoperative data will be compared to intraoperative and postoperative data, and will be analyzed in order to evaluate the dynamic cardiac output changes in women undergoing cesarean sections."
15998403|NCT02902055|Drug|Neuromuscular Blocking Agents|Neuromuscular blockae
15998404|NCT02902055|Drug|Isotonic saline|Placebo
15998405|NCT02902042|Drug|Encorafenib|Dose determined in phase I. Start dose: 450 mg qd
15998406|NCT02902042|Drug|Binimetinib|Dose determined in phase I. Start dose: 45 mg bid
15998407|NCT02902042|Drug|Pembrolizumab|Dose determined in phase I. Start dose: 200 mg q3w
15998408|NCT02902042|Drug|Pembrolizumab alone|200 mg q3w
15998409|NCT02902029|Drug|Vemurafenib|960 mg vemurafenib BID until progression or unacceptable toxicity develops
15998410|NCT02902029|Drug|Cobimetinib|60 mg cobimetinib QD, 21/7 until progression or unacceptable toxicity develops
15998411|NCT02902029|Drug|Atezolizumab|1200 mg atezolizumab administered intravenously on day 1 of each 21 day-cycle. Will be given until progression or unacceptable toxicity develops
15998412|NCT02902016|Drug|GED|Four duodenal biopsies will be collected. Two biopsies will stimulated with GED (PPARgamma modulator) ex vivo during 6 hours. Two biopsies will be unstimulated (control).
15998413|NCT02902003|Behavioral|Empowering Families|A program that integrates the healthy relationship curriculum, Family Wellness, into a comprehensive set of services that includes case management, employment services, and financial coaching. The program will have four core components: (1) 20 hours of core workshop sessions using the Family Wellness curriculum; (2) case management; (3) employment services; and (4) financial coaching. The core component of Empowering Families will be a 20-hour group workshop, organized into eight two-and-a-half-hour weekly sessions (Table 1). The main content of these sessions will be based on the Family Wellness relationship education curriculum which will be covered in six sessions. These six sessions will be led by two trained facilitators employed by The Parenting Center. The core workshops will be supplemented with two additional sessions on financial planning and employment topics that will designed to be useful to all participants, regardless of their level of financial and employment needs.
15998414|NCT02901977|Drug|Ramipril|Antihypertensive therapy
15998415|NCT02901977|Drug|Doxazosin|Antihypertensive therapy
15998416|NCT02901964|Other|Hip Abductor Exercise|12 treatments sessions at 6 weeks: Heating, lower limb stretching, tibiofemoral and patellofemoral mobilization, strengthening the quadriceps, hamstrings, triceps sural and hip abductors.
15998417|NCT02901964|Other|Hip Aductor Exercise|12 treatments sessions at 6 weeks: Heating, lower limb stretching, tibiofemoral and patellofemoral mobilization, strengthening the quadriceps, hamstrings, triceps sural and hip aductors.
15998418|NCT02901951|Biological|Engerix-B|Intramuscular administration of single challenge dose of Engerix-B vaccine in the deltoid region of the non-dominant arm.
15998419|NCT02901938|Procedure|cemented femoral stem|The patients assigned even numbers will undergo implantation of cemented femoral stem.
15998420|NCT02901938|Device|cannulated compression screws|The patients assigned even numbers will undergo percutaneous internal fixation with cannulated compression screws.
15998421|NCT02901925|Drug|ABY-029|Using a sample size of 6-12 patients, ABY-029 will be administered via single intravenous injection to subjects with recurrent glioma, approximately 1-3 hours prior to surgery. Microdose levels of ABY-029 have been selected to determine if a fluorescence signal can be detected by wide-field imaging technology with a signal-to-noise ratio of 10, which is considered necessary for subsequent assessment of diagnostic performance of ABY-029 as a tumor biomarker sufficient to guide surgical resection in the future. Administration of the study drug is not intended to alter the extent of planned brain tumor resection during the surgical procedure.
15998422|NCT02901899|Drug|Guadecitabine|Given SC
15998423|NCT02901899|Other|Laboratory Biomarker Analysis|Correlative studies
15998424|NCT02901899|Biological|Pembrolizumab|Given IV
15998425|NCT02901886|Behavioral|Intensive smoking cessation intervention|The intervention includes 1) Individual motivational counseling (5 meetings within 6 weeks) in combination with 2) nicotine replacement therapy.
15998426|NCT02901873|Device|Electrical Impedance Spectroscopy|
15998427|NCT02901860|Other|Sleep, Dietary and Cardio-metabolic Measurements|"At home session: 2-weeks of wrist actigraphy and sleep diaries; a food diary for the three days preceding the lab session; 24-h period of ambulatory blood pressure on a non-work day for participant. Work schedules over a 4-week period will be collected and participants identified as traditional or non-traditional workers.
~Subjects will begin the stay in the research unit in the evening and will remain for about 16-20 hr. Saliva samples will be taken every 30 min from admission until bedtime. Bedtime with polysomnography will be from 11:00pm to 7:00am. Questionnaires will be administered; height, weight and waist/hip circumference and bioimpedance measurement; standard 3-h oral glucose tolerance test and blood tests (CBC, electrolytes, renal, liver and thyroid function , hemoglobin A1c, SHBG levels). For individuals with diabetes only fasting blood samples will be taken."
15998428|NCT02901847|Other|PAD tailored care|PAD tailored care
15998429|NCT02901821|Genetic|salivary RNA collection|collection of saliva for microRNA (small noncoding RNA) processing
15998430|NCT02901782|Procedure|Personalized titanium plate|3D models of tumor-bearing bone segments were constructed by using computed tomography (CT) and magnetic resonance imaging (MRI). The 3D models were used to design the model of personalized titanium plates. The model of the plates was transferred into a numerical control machine for manufacturing the personalized titanium plates by 3D printing technology. The plates were then surgically implanted for reconstruction assistance following microwave-induced hyperthermia to remove the bone tumor. Implementation parameters and knee function were then evaluated.
15998431|NCT02901769|Other|fMRI|two fMRI paradigms, emotional prosody recognition and decision making
15998432|NCT02901756|Dietary Supplement|Antemig|Participants were instructed to take one tablet every morning for three months.
15998433|NCT02901743|Other|Scaling and Root planing|All the patients were asked to use a preprocedural mouthrinse and scaling and rootplaning was done using ultrasonic scalers.
15998434|NCT02901730|Procedure|532nm laser group|LPI with 532nm laser.
16067614|NCT02400411|Other|ham|
15998436|NCT02901717|Drug|Mino-Lok|Standard of Care antibiotics appropriate for the infecting organism plus Mino-Lok therapy to disinfect and save the catheter.
15998437|NCT02901717|Drug|Antibiotic lock|Standard of Care antibiotics appropriate for the infecting organism with an antibiotic lock solution using the same standard of care antibiotic delivered systemically. The antibiotic lock arm may include subjects with S. aureus, including methicillin-resistant S. aureus, vancomycin intermediate S. aureus, or vancomycin-resistant S. aureus; vancomycin resistant enterococci; Candida, Pseudomonas; other Gram negative organisms; or other organisms deemed to be of high virulence per the Investigator. The standard of care antibiotic will be determined by the investigator at the start of treatment.
15998438|NCT02901704|Device|Renal Denervation System (AngioCare)|After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
15998439|NCT02901704|Procedure|Sham procedure|After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 10 minutes prior to introducer sheath removal.
15998440|NCT02901691|Other|musical rhythmic stimulation|
15998441|NCT02901678|Device|Intrusion by 400 g|using miniscrews and coil springs to apply the intrusive force on maxillary posterior segment intrusion.
15998442|NCT02901665|Other|FCC intervention|Communication to all NICU families that they should be in the NICU a minimum of 4 hours/day.
15998443|NCT02901652|Device|noninvasive respiratory support devices|
15998444|NCT02901639|Other|counseling|
15998445|NCT02901626|Device|Pessary|"The Arabin cervical pessary is a soft, flexible silicone pessary and fits high around the cervix with no rigid metal framework or inflexible edges that put increase pressure on the vaginal wall. It is available in a variety of sizes however three sizes will be used in this study:
~Pessary Size Upper diameter, lower diameter
~Nulliparous 65 mm, 32 mm
~Multiparous 70 mm, 32 mm
~Alternative 70 mm, 35 mm"
15998446|NCT02901613|Device|Negative-pressure wound therapy|
15998447|NCT02901600|Other|Detection of the expression of DMTB1 by immunohistochemistry|
15998448|NCT02901587|Drug|Lu AF35700 (10 mg/day)|tablets for oral administration once daily
15998449|NCT02901587|Drug|Lu AF35700 (30 mg/day)|tablets for oral administration once daily
15998450|NCT02901587|Drug|Quetiapine (Seroquel XR® 800 mg/day)|tablets for oral administration once daily
15998451|NCT02901574|Device|Anodal or Cathodal tDCS|2 mA or Anodal or Cathodal tDCS stimulation is induced between 5cm X5 cm saline soaked sponges where one sponge (anode in group anode or cathode in group cathode) is placed on the right cerebellum. The stimulation will be delivered at an intensity of 2 mA in a ramp-like fashion for a maximum of 20 minutes.
15998452|NCT02901574|Device|Sham|2 mA of Anodal tDCS or Cathodal tDCS is induced between two 5cm X 5cn saline soaked sponges where one sponge (anode in group Anode and cathode in group Cathode) is placed on the right cerebellum. Ramping up of the current to 2 mA occurs over 15-30 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition. Termination of the stimulation after the ramping up process is generally undetectable, and the brief duration of stimulation yields no functional effects.
15998453|NCT02901574|Behavioral|Computerized naming therapy|Computer delivered naming treatment requires matching (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red button if the word does not match the picture.
15998454|NCT02901561|Drug|misoprostol 200|
15998455|NCT02901561|Drug|misoprostol 400|
15998458|NCT02901535|Other|Spirometry|Spirometry in baseline
15998459|NCT02901535|Other|telemonitoring|telemonitoring (phone call nurse - 45 and 90 days)
15998460|NCT02901535|Other|teleconsultation|teleconsultation (general practioner received phone call to respiratory care)
15998461|NCT02901535|Other|Spirometry - 20 weeks|Spirometry (20 weeks)
15998462|NCT02901522|Other|telemonitoring|Patients is evaluated by telemonitoring (phone call nurse - 45 and 90 days).
15998463|NCT02901522|Other|Spirometry (baseline)|Patients is evaluated by Asthma Control Test and spirometry at baseline and after 20 weeks.
15998464|NCT02901522|Other|Spirometry (20 - 22weeks)|Patients is evaluated by Asthma Control Test and spirometry at baseline and after 20 weeks.
15998465|NCT02901522|Other|Teleconsultation|The general practioner received phone call to asthma care.
15998466|NCT02901496|Behavioral|Endurance Exercise Training|Three months of supervised training. Interval training, 3 sessions weekly of 45 min. During intervals the intensity will be minimum 70 % of VO2 max
15998467|NCT02901496|Behavioral|Resistance Exercise Training|Three months of supervised resistance training. Subjects will perform 3 weekly sessions of 45 min. The intensity will be kept at minimum 60% of 1RM.
15998468|NCT02901496|Behavioral|No Exercise|Control to exercise
15998469|NCT02901496|Drug|Tocilizumab|Tocilizumab infusion will be administered monthly (8 mg/kg body weight i.v., maximun 800 mg). Each subject will receive 3 infusions during the study period.
15998470|NCT02901496|Drug|Placebo|Saline infusion will be administered monthly (same volume as Tocilizumab). Each subject will receive 3 infusions during the study period.
15998471|NCT02901483|Drug|PEP503|PEP503 will be administered by intratumoral route as slow injection
15998723|NCT02899364|Drug|Sodium thiosulfate|see description under experimental arm
15998472|NCT02901483|Drug|Cisplatin|The concurrent chemoradiotherapy. Weekly cisplatin 40 mg/m2 or tri-weekly 100 mg/m2, depending on which dose level patients are in, with a minimum of accumulated 200 mg/m2 during the 7~8 weeks' radiation period.
15998473|NCT02901483|Radiation|Radiotherapy|Patients will receive 70-72 Gy, 2-2.12 Gy/fraction over 7~8 weeks.
15998474|NCT02901457|Other|"The Healthy Body Image intervention"|Interactive workshops (3 x 90 minutes) include training techniques to increase media literacy, enhance self-esteem, positive body image, awareness of perfectionism, and include discussions related to truths and myths related to life style factors. Homework is an extension of each workshop that is simple and not time-consuming tasks to increase reflection and awareness of how all the mentioned factors are a part of their lives.
15998475|NCT02901431|Drug|Placebo|Participants received a matching placebo orally. Approximate treatment duration was up to 24 weeks.
15998476|NCT02901431|Drug|RO5285119|Participants received age-adjusted total daily oral dose approximately equivalent to the adult doses of either 4 mg/d or 10 mg/d of balovaptan (RO5285119). Approximate treatment duration was up to 24 weeks (up to 52 additional weeks for those enrolled in the OLE).
15998477|NCT02901418|Biological|200 IU HBIG|additional 200 IU HBIG within 24 hours was used for the experimental group of newborns
15998478|NCT02901405|Device|Negative Pressure Wound Therapy (ActivVAC, KCI)|
15998479|NCT02901405|Device|Standard dressings|Current absorbent dressing is 'tegaderm with absorbent pad' (3M)
15998480|NCT02901392|Procedure|AMS-800|Artificial urianry sphincter
15998481|NCT02901392|Procedure|ADVANCE/ADVANCEXP|Male sling
15998482|NCT02901392|Procedure|VIRTUE|Male sling
15998483|NCT02901392|Procedure|INVANCE|Male sling
15998484|NCT02901379|Drug|Atorvastatin 80mg|Subject will be given atorvastatin 80mg for two weeks
15998485|NCT02901379|Drug|Atorvastatin 10mg|Subjects will be give atorvastatin 10mg as part of standard therapy in hospital
15998486|NCT02901366|Drug|14C-FYU-981|14C-FYU-981, (Oral single dosing)
15998487|NCT02901353|Device|Sirolimus Eluting Coronary Stent System|Patient with Angina Pectoris will be enrolled for the intervention
15998488|NCT02901340|Dietary Supplement|one to two liters of water daily|
15998489|NCT02901327|Procedure|Lumbar Stabilisation Exercise|"McGill protocol starting with:
~'cat-camel' exercise exercise 10 repetitions with 7 seconds hold each
~'curl-up' exercise 10 repetitions with 7 seconds hold each
~'side-bridge' exercise 10 repetitions with 7 seconds hold each
~'cat-camel' exercise 10 repetitions with 7 seconds hold each progression was based on subjects' tolerance and endurance."
15998490|NCT02901327|Procedure|treadmill walk exercise|"Bruce protocol
~This include:
~'5 minutes warm up' at zero degree inclination.
~'20 minutes active exercise with increasing speed and inclination'
~'5 minutes cool down'"
15998491|NCT02901314|Other|on-demand audio messages of heart failure education themes|
15998492|NCT02901301|Drug|Pembrolizumab|200mg, IV, q3weeks, Day 1
15998493|NCT02901301|Drug|Trastuzumab|6mg/kg (8mg loading dose), IV, q3weeks, Day 1
15998494|NCT02901301|Drug|Capecitabine|1000mg/m2, PO, BID, Day 1-14
15998495|NCT02901301|Drug|Cisplatin|80mg/m2 (level 1), IV, q3weeks, Day 1
15998496|NCT02901288|Drug|Isoniazid|Isoniazid is a widely used anti-tuberculosis medication. Its primary action is to inhibit the synthesis of long-chain mycolic acids, which are unique components of mycobacterial cell wall.
15998497|NCT02901288|Drug|Rifampicin|Rifampicin is a widely used anti-tuberculosis medication.
15998498|NCT02901288|Drug|Pyrazinamide|Pyrazinamide is a commonly used medication for tuberculosis, with bactericidal effect against intracellular mycobacterium tuberculosis.
15998499|NCT02901288|Drug|Ethambutol|Ethambutol is a widely used medicine in anti-TB regimens with bacteriostatic effect against M. tb.
15998500|NCT02901288|Drug|Levofloxacin|Levofloxacin is a commonly used antimicrobial for TB and other infections, which acts on the DNA-DNA-gyrase complex and topoisomerase IV. It is the S (-) enantiomer of the racemic active substance ofloxacin.
15998501|NCT02901275|Drug|Within-subject test of blinded study medications|Within-subject double-blind, double-dummy, study design wherein all participants received all doses in 8-hour outpatient sessions. Primary outcomes assessed during 8-hour outpatient sessions and included laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition.
15998502|NCT02901249|Drug|sertraline|
15998503|NCT02901249|Drug|Nortriptyline|
15998504|NCT02901249|Drug|Lithium|
15998505|NCT02901236|Procedure|Standard Guarded Trabeculectomy|A fornix based conjunctival peritomy is performed. A partial thickness scleral flap is dissected. Then trabeculectomy is performed with a Kelly's punch. A surgical iridectomy is performed. The scleral flap is secured with two pre-placed 8-0 Vicryl sutures (Ethicon, Somerville, NJ). The anterior chamber (AC) is inflated with balanced salt solution and suture tension is adjusted. Finally, conjunctiva is closed with 10-0 running Nylon sutures (Ethicon, Somerville, NJ). Patients receive a subconjunctival injection of 0.4 ml dexamethasone (4 mg/ml) and of 0.4 ml gentamicin (40 mg/ml) at the end of the case. Adjuvant pharmacologic treatment to prevent episcleral fibrosis and failure of the procedure is applied according to treatment arm assignment.
15998506|NCT02901236|Drug|Mitomycin C|Sponges soaked in 0.02% mitomycin C (MMC) will be applied on bare sclera for 2 minutes. Subsequently, the area will be copiously irrigated with balanced salt solution.
15998507|NCT02901236|Drug|Bevacizumab|After conjunctival closure 1.25mg of bevacizumab will be injected into the anterior chamber through a paracentesis created earlier during the case.
15998508|NCT02901223|Procedure|Standard quadrantectomy|standard conservative surgery with no use of any plastic techniques
15998509|NCT02901223|Procedure|oncoplastic breast surgery|Integration of plastic techniques with oncological procedures
15998510|NCT02901210|Procedure|Modified delorme procedure|
15998511|NCT02901197|Behavioral|Education and Reminder Posters|See arm description
15998512|NCT02901197|Other|Policy Change|See arm description
15998513|NCT02901184|Drug|Spironolactone|Treatment with Spironolactone tablets on top of standard care
15998514|NCT02901184|Other|Standard care|Standard care does not involve Spironolactone
15998550|NCT02900911|Other|Late rehabilitation|Late swallowing exercises and respiratory muscle training: Standard swallow therapy and instructions for training submental muscles involved in swallowing function and expiratory strength starting after completing radiotherapy
16067615|NCT02400411|Other|soup|
15998515|NCT02901171|Behavioral|ACT group treatment combined with smartphone application|The Acceptance and Commitment Therapy (ACT) group treatment for smoking cessation will be delivered in six weekly 90-min sessions. Smoking cessation will be promoted in each session by targeting core processes of the ACT model including acceptance, cognitive defusion, mindfulness, flexible perspective taking, values clarification and committed action. In addition, participants will receive an ACT-based smartphone application for smoking cessation. The application will foster core processes of the ACT model through daily exercises, tips and tools.
15998516|NCT02901171|Behavioral|ACT group treatment|
15998517|NCT02901171|Behavioral|Group based Behavioural Support Programme|The Behavioural Support Programme will be facilitated by stop smoking experts and delivered in six weekly 90-min sessions in a group format. During the sessions, advice, support and information on smoking cessation will be given to participants and behavioural techniques will be reviewed.
15998518|NCT02901145|Drug|Nivolumab,low dose cyclophosphamide|treatment with IV Nivolumab 3mg/kg every 2 weeks . after a month-addition of low dose cyclophosphamide at a starting dose of 50 mg/kg/day x7 days every 14 days with dose adaptation based on level of Tregulatory cells on follow up immunophenotype.
15998519|NCT02901119|Dietary Supplement|Whey protein|Patients, maintaining their regular usual diet, are submitted to a protein supplementation, during 15 days. They recieve 20g packages of whey protein or casein, to take twice a day: 20g in the morning and 20g at night.
15998520|NCT02901106|Drug|Dimethyl fumarate|"Patient follow-up at 6, 12, 18, 36, and 60 months after the start of Dimethyl fumarate
~Systematization of cerebral MRI examination at 18 month and 5 years from the beginning of treatment by Dimethyl fumarate"
15998521|NCT02901080|Device|Alpha Stim AID cranial electrotherapy stimulation|- 60 minutes of cranial electrotherapy stimulation via Alpha Stim AID once per day, for a minimum of 6 and maximum of 12 weeks.
15998522|NCT02901080|Behavioral|Pregnancy test|- Pregnancy test x 1 (day 1)
15998523|NCT02901080|Other|Anxiety questionnaire|- GAD-7 questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)
15998524|NCT02901080|Other|Quality of life questionnaire|- EQ-5D-5L questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)
15998525|NCT02901080|Other|Work and social questionnaire|- WASA questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)
15998526|NCT02901080|Other|Sleep questionnaire|- Athens questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)
15998527|NCT02901080|Other|Depression questionnaire|- PHQ-9 questionnaire x 6 (day 1, week 4, week 6, week 8, week 12 and week 24)
15998528|NCT02901080|Other|Quality of life and financial questionnaire|- CSRI questionnaire x 3 (day 1, week 12 and week 24)
15998529|NCT02901067|Drug|Aspirin and Rosuvastatin|Patients assigned to the intervention arm will receive the standard of care anti-coagulation plus the combination experimental drugs (20mg of rosuvastatin daily and 325mg of aspirin) daily either orally or via feeding tube.
15998530|NCT02901067|Drug|Placebo (for Aspirin and Rosuvastatin)|Patients assigned to the control group will receive the standard of care anti-coagulation plus identical-looking placebos either orally or via feeding tube.
15998531|NCT02901054|Drug|Ondansetron|A single 15-min intravenous infusion of ondansetron
15998532|NCT02901041|Drug|Zonisamide|ZONEGRAN® (zonisamide) is an antiseizure drug chemically classified as a sulfonamide and unrelated to other antiseizure agents. A dose of 400 mg daily will be used as the target maintenance dose in this study but dosing will be modified if needed to adjust for subject tolerance of drug dosing.
15998533|NCT02901041|Behavioral|Take Control|"Take Control is a seven module computer-based intervention which presents evidence-based alcohol education that includes motivational interviewing and cognitive-behavioral skills building. This program is derived from the National Institute on Alcohol Abuse and Alcoholism's (NIAAA's) self-help approach, Rethinking Drinking.
~Starting on March 23, 2020, participants will participate in a simplified Take Control treatment at home due to the COVID-19 pandemic"
15998534|NCT02901041|Drug|Placebo (for Zonisamide)|Sugar pills manufactured to mimic Zonisamide capsules.
15998535|NCT02901028|Other|Laboratory testing|Subjects will visit the Human Performance Laboratory on two separate occasions to perform the testing procedures. testing consists of VO2, strength, biomechanics, dynavision, etc.
15998536|NCT02901028|Other|Blood and Urine Draws|subjects will have a blood draw and provide a urine sample
15998537|NCT02901015|Behavioral|Assessment battery A|"Social cognition tests version A are administered to the patients"
15998538|NCT02901015|Behavioral|Assessment battery B|"Social cognition tests version B are administered to the patients"
15998539|NCT02901002|Other|Sensory testing in the two hand|spontaneous sensations while watching a hand
15998540|NCT02901002|Other|Neuropsychological evaluation|Score to anxiety-depression scale
15998541|NCT02900989|Behavioral|Suicide screening|"Patients of the emergency unit usually do not pass this kind of questionnaire in the absence of warning signs. Then it could result in adverse effects on behavior and ideation.
~The study had to be declared as an interventional study according to French law."
15998542|NCT02900976|Biological|Allogeneic LMP1/LMP2-Specific Cytotoxic T-Lymphocytes|Given IV
15998543|NCT02900976|Biological|Rituximab|Given IV
15998544|NCT02900963|Other|weekly assessment of patient's weight|Biological assessment to determine biological and inflammatory status Quality of life questionary
15998545|NCT02900950|Procedure|Multicolour inking specimens|
15998546|NCT02900950|Procedure|Monocolour inking specimens|
15998547|NCT02900937|Device|AmM MAGNITUDE Bioresorbable Drug-Eluting Coronary Scaffold|Placement of the investigational device into the diseased coronary artery to eliminate the vascular stenosis.
15998548|NCT02900924|Device|BioMimics 3D Stent|
15998549|NCT02900911|Other|Early rehabilitation|"Early swallowing exercises and respiratory muscle training: Standard swallow therapy and instructions for training submental muscles involved in swallowing function and expiratory strength starting 2 weeks before radiotherapy
~Expiratory/Inspiratory training: the training load is the maximum inspiratory/expiratory load defined according to patient tolerance. This load will be equivalent to 10 maximal repetitions (RM) as 10 consecutive inspirations (x 5 sessions), three times a day.
~All sessions will be conducted under the supervision of an expert physiotherapist/swallowing therapist. The total duration of the training program is 6 months."
15998551|NCT02900898|Other|Dynamic exercise and Mediterranean diet|DE, MD
15998552|NCT02900898|Other|Dynamic exercise|DE
15998553|NCT02900898|Other|Mediterranean diet|MD
15998555|NCT02900820|Other|Discontinuing antibiotic therapy|Patients assigned to this group will be asked to discontinue antibiotic therapy.
15998556|NCT02900820|Other|Continuing antibiotic therapy|Patients assigned to this group will be asked to complete antibiotic therapy.
15998557|NCT02900794|Device|Gold Laser|Under endoscopic visualization, the Gold Laser will be utilized to perform 1) excision of the concha bullosa, 2) maxillary antrostomy, and 3) submucosal cauterization of the turbinates. Suction/irrigation will be utilized as necessary.
15998558|NCT02900794|Procedure|Microdebridement|Under endoscopic visualization, the microdebrider will be utilized to perform 1) excision of the concha bullosa, 2) maxillary antrostomy, and 3) submucosal cauterization of the turbinates.
15998559|NCT02900781|Device|Steprite™|Steprite™ Device shoe insert monitoring device
15998560|NCT02900781|Other|Standard of care|No Device. Standard of care physical therapy
15998561|NCT02900768|Behavioral|Exercise|Combination of resistance and aerobic exercises for 100 days.
15998562|NCT02900755|Drug|Perampanel|The subjects will be administered oral perampanel for six months. Dose will be titrated according to the tolerance and be maintained at least 1 month before second EEG evaluation.
15998563|NCT02900742|Drug|YiQiFang|Prescriptions formulated into TCM granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi, benefiting Yin and detoxication recipe. YiQiFang: Patients with Qi deficiency syndrome are administered two packages of each benefiting Qi and detoxication recipe, four packages, twice a day, until progression or unacceptable.
15998564|NCT02900742|Drug|YangYinFang|Prescriptions formulated into TCM granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi, benefiting Yin and detoxication recipe. YangYinFang: Patients with Yin deficiency syndrome are administered two packages of each benefiting Yin and detoxication recipe, four packages, twice a day, until progression or unacceptable.
15998565|NCT02900742|Drug|YiQiYangYinFang|Prescriptions formulated into TCM granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi, benefiting Yin and detoxication recipe. YiQiYangYinFang: Patients with Qi and Yin deficiency syndrome are administered one package of each benefiting Qi and benefiting Yin and two packages of detoxication recipe, four packages, twice a day, until progression or unacceptable.
15998566|NCT02900742|Drug|Gemcitabine®|"Gemcitabinie®,Gemzar,1250 mg/㎡, ivgtt 30 min,days 1,8,every 21 days until progression or unacceptable toxicity develops."
15998567|NCT02900742|Drug|Pemetrexed®|"Pemetrexed®,Alimta,500 mg/㎡, ivgtt 30 min, day 1, every 21 days until progression or unacceptable toxicity develops."
15998568|NCT02900742|Drug|Docetaxel®|"Docetaxel®,Taxotere,75 mg/㎡, ivgtt 30 min, day 1, every 21 days until progression or unacceptable toxicity."
15998569|NCT02900742|Drug|placebo granules|Oral granules, which the taste and smell are similar to experimental TCM granules, has no therapeutic effect, four packages, twice a day, until progression or unacceptable.
15998570|NCT02900729|Device|Radiofrequency ablation catheter|Subjects will be treated with the renal denervation procedure using WiseGo Catheter System after randomization.
15998571|NCT02900729|Drug|Amlodipine, losartan potassium and hydrochlorothiazide|Standardised triple anti-hypertensive medications of amlodipine 5 mg per day, losartan potassium 50 mg and hydrochlorothiazide 12.5 mg per day in the first 90 days after randomization. Subjects will be allowed to adjust baseline antihypertensive medications where clinically necessary in the second 90 days after randomization.
15998572|NCT02900716|Drug|DTRMWXHS-12|DTRMWXHS-12
15998573|NCT02900716|Drug|DTRM-505|DTRMWXHS-12 and everolimus
15998574|NCT02900716|Drug|DTRM-555|DTRMWXHS-12 and everolimus and pomalidomide
15998575|NCT02900703|Biological|stool samples|
15998576|NCT02900677|Behavioral|Physical and nutrition program|6 education programs with physical enhancement and nutrition related information for 12 weeks
15998577|NCT02900664|Biological|PDR001|Powder for solution for infusion
15998578|NCT02900664|Biological|ACZ885|Solution for injection
15998579|NCT02900664|Biological|CJM112|Solution for infusion
15998580|NCT02900664|Drug|TMT212|Tablets
15998581|NCT02900664|Drug|EGF816|Tablets
15998582|NCT02900651|Drug|MAK683|Drug: MAK683
15998583|NCT02900638|Behavioral|Mentoring|Youth in the intervention group will participate in one-on-one mentoring sessions (between mentors and mentees) once per week after school. Mentoring sessions will focus on the development of a social bond between mentor and mentee.
15998584|NCT02900612|Other|Water aerobics training.|The WA group will be trained adopting the interval method, performing six blocks of five minutes each one, alternating four minutes at intensities corresponding to 90 to 100% of the heart rate corresponding to the second ventilatory threshold (HRVT2) and one minute at intensities between 80 and 90% HRVT2.
15998585|NCT02900612|Other|Water resistance training.|The WR group will perform four to eight sets of 20 to 10 seconds along the macrocycle, always at maximal speed execution of the exercises.
15998586|NCT02900612|Other|Control Group|The control group will perform relaxation classes, including meditation, balance exercises, coordination exercises.
15998587|NCT02900599|Other|Observationnal (no intervention)|
15998588|NCT02900560|Drug|CC-486|CC-486 Intervention will depend on cohort enrolled in. 100 mg tablet
15998589|NCT02900560|Biological|Pembrolizumab|Pembrolizumab 200 mg IV every 21 days
15998590|NCT02900547|Other|Patients with systolic heart failure|
15998591|NCT02900534|Other|Internet-based self-help|10 internet-based self-help sessions plus one supportive email a week with a cognitive-behavioural background
15998592|NCT02900508|Other|Exergaming training|
15998593|NCT02900508|Other|Physical therapy intervention|
15998594|NCT02900495|Device|transcutaneous electric nerve stimulation|electrodes placed per treatment arm, performed at bedtime, session time 15 min, frequency setting of 10 Hz, intensity setting to patient's tolerance, duration 30 days
15998595|NCT02900482|Other|Sampling saliva|
15998596|NCT02900469|Biological|denosumab|denosumab: 120 mg subcutaneous injection
15998597|NCT02900469|Procedure|Surgery|Surgery: approximately 2-4 weeks after dosing of denosumab
15998598|NCT02900443|Drug|Mycophenolate mofetil|
15998599|NCT02900443|Drug|Azathioprine|
16000122|NCT02888457|Other|Nasopharyngeal sampling with a swab|
15998600|NCT02900430|Other|Patients without antifungal prophylaxis|Epidemiology data: clinical and biological informations collecting
15998601|NCT02900430|Drug|Patients with antifungal prophylaxis|Hospitalized patients between 2012 and 2015 received Posaconazole prophylaxis during neutropenia period induced by induction or salvage chemotherapy.
15998602|NCT02900417|Drug|Sitagliptin|All the patients will receive sitagliptin 100mg daily
15998603|NCT02900404|Other|XAPPORT|A mobile device app based on different guidelines provides adequate guidance to physicians attending patients undergoing elective surgery, who have to interrupt treatment with rivaroxaban for surgery, in deciding how to approach the pre- and postoperative management of anticoagulation.
15998604|NCT02900404|Other|"Expert Panel (gold standard)"|A national panel of experts comprising anesthetists and surgeons from various disciplines advised in developing an algorithm supporting physicians how to approach the perioperative management of anticoagulation in patients receiving rivaroxaban and requiring elective surgery.
15998605|NCT02900378|Drug|LCZ696 (Sacubitril/Valsartan)|LCZ696 (sacubitril/valsartan) was available in 24 mg/26 mg, 49 mg/51 and 97 mg/103 mg mg film-coated tablets
15998606|NCT02900378|Drug|Placebo of LCZ696 (Sacubitril/Valsartan)|Placebo of LCZ696 (sacubitril/valsartan) was available to match 24 mg/26 mg, 49 mg/51 and 97 mg/103 mg mg film-coated tablets
15998607|NCT02900378|Drug|Enalapril|Enalapril was available in 2.5 mg, 5 mg and 10 mg film-coated tablets
15998608|NCT02900378|Drug|Placebo of Enalapril|Placebo of Enalapril was available to match 2.5 mg, 5 mg and 10 mg film-coated tablets
15998609|NCT02900365|Procedure|early cataract surgery & IOL implantation|first week cataract extraction and IOL implantation.
15998610|NCT02900365|Procedure|late cataract surgery & IOL implantation|first month cataract extraction and IOL implantation.
15998611|NCT02900352|Drug|Zonisamide|Titration of dose to 500mg oral, daily, over 8 weeks, then 7 weeks of treatment at that dose
15998612|NCT02900352|Drug|Placebo|Placebo
15998613|NCT02900339|Device|Magnetic Resonance Imaging|MRI of the Neurinfo platform is an MRI 3 Tesla Magnetom Verio model, Siemens (Siemens Healthcare, Erlangen, Germany). This imager is marked for European Conformity (CE), ensuring compliance with European Union safety standards.
15998614|NCT02900326|Other|Endurance exercise training|In each group, there will be a comparison of aerobic capacity, quality of life (with questionnaires), functional cerebral measurements (fRMI), and telomerase activity between before and after the 8 weeks program
15998615|NCT02900326|Other|Mindfulness-based-stress-reduction|
15998616|NCT02900326|Other|Both interventions together|
15998617|NCT02900326|Other|Vo2max measurements|
15998618|NCT02900326|Genetic|Telomerase activity on a blood sample|
15998619|NCT02900326|Other|Quality of life (questionnaires)|
15998620|NCT02900326|Other|Cerebral IRMf|
15998621|NCT02900313|Other|cardiac surgery|Cohort of patients who are more than 18 years having cardiac surgery and having benefited from a dosage of serum phosphorus level and serum creatinine during all the duration of the hospitalisation
15998622|NCT02900274|Device|VascuFlex Multi-LOC®|Multi-LOC® peripheral stent system for bailout stenting after Plain Old Balloon Angioplasty (POBA) or Drug Coated Balloon (DCB) Angioplasty
15998623|NCT02900261|Other|No intervention|This study is observational and does not entail any intervention. Different methods to assess sodium and caffeine consumption will be compared.
15998624|NCT02900248|Other|Provider determined|Provider will treat patient as he/she feels best
15998625|NCT02900235|Drug|MT-3995|
15998626|NCT02900222|Procedure|endoscopic choroid plexus coagulation|A burr hole will be made over the frontal lobe of the brain. An endoscope will be introduced into the ventricle of the brain and the choroid plexus coagulated with an electrocautery device. The septum pellucidum separating the right and left lateral ventricles will be opened, and the choroid plexus on the opposite side coagulated as well.
15998627|NCT02900209|Other|Influenza Vaccination|
15998628|NCT02900196|Other|1 - Fermented dairy drink|1 - Fresh fermented dairy drink containing yoghurt ferments and probiotic strains consumed as follows: one bottle (100g) BID for 28 consecutive days (Day 0 to day 28)
15998629|NCT02900196|Other|2 - Acidified dairy drink|2 - Acidified dairy drink without ferments consumed as follows: one bottle (100g) BID for 28 consecutive days (Day 0 to day 28)
15998630|NCT02900183|Drug|ARC-AAT Injection|RNA interference (RNAi)-based, liver-targeted therapeutic
15998631|NCT02900157|Biological|MEDI9090|MEDI9090 will be administered by IV infusion
15998632|NCT02900157|Biological|Durvalumab|Durvalumab as a single agent will be administered by IV infusion after patients have completed the prescribed doses of Medi9090.
15998633|NCT02900144|Behavioral|Modified Comprehensive Behavioral Intervention for Tics|In this arm, participants will receive the modified CBIT protocol. In addition to addressing tics, the treatment in this arm will also directly address ADHD symptoms using CBT for ADHD techniques, and quality of life concerns. The treatment itself will be modified to be more accessible to an ADHD population. The treatment will consist of twelve 50-min sessions: ten weekly and then two every other week for relapse prevention.
15998634|NCT02900144|Behavioral|Comprehensive Behavioral Intervention for Tics|In this arm, participants will receive the standard CBIT intervention (Piacentini et al 2010). The primary components of CBIT are habit reversal training, relaxation training and a functional interventional to assess the environment for situations/factors that exacerbate or sustain tics. The treatment will consist of twelve 50-min sessions: ten weekly and then two every other week for relapse prevention.
15998635|NCT02900131|Drug|Jaungo|Participants in trial group 1 will apply Jaungo and placebo to the lesion once a day for three weeks. Participants in trial group 2 will apply Jaungo to the lesion twice a day for three weeks.
15998636|NCT02900131|Drug|Placebo|Participants in trial group 1 will apply Jaungo and placebo to the lesion once a day for three weeks. Participants in control group will apply placebo to the lesion twice a day for three weeks.
15998637|NCT02900105|Drug|Letrozole|Letrozole 2.5mg (1 tablet) once a day for 4 months
15998638|NCT02900092|Drug|Ganaxolone|Participants received ganaxolone
15998639|NCT02900079|Device|rapid diagnostic test for malaria antigen|rapid diagnostic test for malaria antigen to be used by travelers when febrile
15998640|NCT02900053|Device|tDCS|tDCS for transcranial Direct-Current Stimulation
15998641|NCT02900053|Device|Placebo tDCS|Placebo tDCS for transcranial Direct-Current Stimulation
15998643|NCT02900027|Drug|APOC-III-L-Rx|Ascending single and multiple doses of IONIS-APOC-III-LRx by subcutaneous (SC) injection
15998644|NCT02900027|Drug|Placebo Comparator|Sterile Normal Saline (0.9% NaCl) calculated volume to match active comparator
15998645|NCT02900014|Procedure|sampling mesenchymal stem cells|nasal mesenchymental stem cells are collected in patients with cleft undergoing general anesthesia, during the initial surgical management of cleft
15998646|NCT02900001|Procedure|early coronary angiography|Routine coronary angiography and revascularization if appropriate within 24 hours
15998647|NCT02900001|Procedure|delayed coronary angiography|Routine coronary angiography and revascularization if appropriate after 72 hours
15998648|NCT02899988|Drug|Mirikizumab|Administered SC
15998649|NCT02899988|Drug|Placebo|Administered SC
15998650|NCT02899975|Other|Validation|Validation of fitness and information software for elderly and caregivers. The participants use a Fitness Software for 2-3 months in their own homes. They should use it 3 times a week The aim of this Intervention is to find out if the regularly use of the Software maintains or improves your physical capabilities. The caregivers also use the games and get a lot of Information about supporting the elderly Person in their everyday life
15998651|NCT02899962|Drug|LEO 90100 aerosol foam|LEO 90100 aerosol foam twice weekly
15998652|NCT02899962|Drug|LEO 90100 aerosol foam vehicle|LEO 90100 aerosol foam vehicle twice weekly
15998653|NCT02899936|Drug|3 drug dose - IDA|Lymphatic Filariasis Mass Drug Administration (MDA) with triple drug therapy of ivermectin, diethylcarbamazine, and albendazole (IDA)
15998654|NCT02899936|Drug|2 drug dose - DA|Lymphatic Filariasis Mass Drug Administration (MDA) with the currently used standard of care combination drug therapy of diethylcarbamazine, and albendazole (DA)
15998655|NCT02899923|Other|Data collection|
15998656|NCT02899910|Behavioral|Health education|Education on lifestyle changes for treatment of metabolic syndrome
15998657|NCT02899910|Behavioral|Yoga|Training in the practice of yoga for treatment of metabolic syndrome
15998658|NCT02899897|Device|echocardiography in IV fluid therapy|
15998659|NCT02899884|Other|No Intervention|
15998660|NCT02899871|Other|diagnosis of joint|"The diagnosis of joint pain will be established by a rheumatologist and completed:
~If necessary, by a clinically guided radiological assessment (plain x-rays, joint ultrasound, bone and joint MRI).
~serum assays of the anti-TNF administered, as well as screening for associated antibodies."
15998661|NCT02899858|Other|Movement Assessment|Documentation of ASIA A (T2-8) status at Belmont Gait Lab
15998662|NCT02899858|Other|MRI Scan|Total MRI of spine to evaluate condition of spinal cord
15998663|NCT02899858|Procedure|IntraSpinal Micro-Stimulation|IntraSpinal Micro-Stimulation will be performed using a maximum of 16 electrodes inserted along each side of spinal cord that correlate with movements created across all 3 joints (hips, knees, and ankles)
15998664|NCT02899858|Other|Follow up clinical exam|All subjects will be expected to return for a follow-up visit with Drs. Konrad at 1, 3 and 6 month follow up visits.
15998665|NCT02899858|Other|Post Op MRI Scan|An MRI will be obtained at 3 months following the procedure to document the impact of the mapping procedure on spinal cord anatomy.
15998666|NCT02899858|Other|Follow up gait assessment|Follow-up assessment with the Belmont Gait Lab will be performed at the 6 month follow up visit
15998667|NCT02899845|Other|postural task|
15998668|NCT02899845|Other|walk task|
15998669|NCT02899832|Device|NIRS|Near Infra Red Spectroscopy
15998670|NCT02899819|Other|meconium|The meconium will be sampled in the first 2 days of life
15998671|NCT02899806|Other|Written Information|A written information on peridural anesthesia is delivered
15998672|NCT02899806|Other|Video Information|A link to a video explaining peridural anesthesia is delivered to the pregnant woman. The patient can watch the video several times.
15998673|NCT02899793|Drug|Pembrolizumab|Pembrolizumab 200 mg (fixed dose) IV every 3 weeks (+/- 3 days) until progression or adverse effects prohibit therapy
15998674|NCT02899780|Device|Ultraviolet light emitting optical fiber|A ultraviolet light emitting optical fiber will be threaded through the existing catheter and withdrawn.
15998675|NCT02899754|Behavioral|Lung Cancer Screening Decision Tool|This will be a lung cancer screening decision support tool that is web based and provides patients with information about the potential benefits and harms associated with lung cancer screening and helps them to consider their personal values when making a decision about whether to initiate or continue with lung cancer screening.
15998676|NCT02899754|Behavioral|Control Intervention|This will be a health message regarding prevention and healthy behavior that is not related to lung cancer screening but delivered in a similar modality and taking approximately the same amount of time as the LCSDecTool.
15998677|NCT02899741|Drug|Omega-3|1000mg every day for 90 days
15998678|NCT02899728|Drug|Carboplatin|Given IV
15998679|NCT02899728|Drug|Cediranib|Given PO
15998680|NCT02899728|Drug|Cediranib Maleate|Given PO
15998681|NCT02899728|Drug|Cisplatin|Given IV
15998682|NCT02899728|Drug|Etoposide|Given IV
15998683|NCT02899728|Drug|Olaparib|Given PO
15998684|NCT02899702|Drug|PRIVIGEN (CSL Behring)|"Single administration of intravenous immunoglobulin solution Privigen® (CSL Behring AG, Bern, Switzerland) at a dose of 2g / kg. IGIV 2g/kg within 12 hours following PICU admission (or outbreak of first shock signs).
~The treatment of toxic shock will be standardized. It consists of antibiotics: Amoxicillin-clavulanate and clindamycin (or Rifampicin, Rifadine® if allergic). Antibiotics are not considered as experimental treatments for this study. All treatments essential for the treatment of acute condition will be allowed and are not considered as experimental treatments for this study."
15998685|NCT02899702|Drug|Albumin|"4%(LFB) ALBUMIN Single administration of human Albumin 4% diluted albumin (VIALEBEX® LFB), within 12 hours following PICU admission (or outbreak of first shock signs). Isovolume - so dose of 0.8 g/kg (4gG, 100 ML, Sodium chloride 0.61 G / 100ML Water for injections QSP 100 ML Sodium caprylate 0.3 G / 100ML) We chose as placebo albumin diluted to 4% because this solution has the advantage of having a comparable osmolality.
~The treatment of toxic shock will be standardized. It consists of antibiotics: Amoxicillin-clavulanate and clindamycin (or Rifampicin, Rifadine® if allergic). Antibiotics are not considered as experimental treatments for this study. All treatments essential for the treatment of acute condition will be allowed and are not considered as experimental treatments for this study."
16000123|NCT02888444|Drug|Varenicline|Two 0.5mg tablets taken twice daily
15998686|NCT02899689|Device|Dilapan|Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, synthetic osmotic dilators (Dilapan-S) are inserted into the cervical canal with special attention to cross through the internal os.
15998687|NCT02899689|Device|Foley Catheter|Using a sterile speculum, the cervix is visualized and cleaned with iodine. Under direct visualization, a Foley catheter is inserted into the cervix and the balloon is filled with 60 ml of sterile 0.9% NaCl.
15998688|NCT02899676|Other|neuropsychological testing|
15998689|NCT02899676|Other|functional magnetic resonance imaging|
15998690|NCT02899676|Other|simple arithmetic operations|
15998691|NCT02899650|Other|exercise|acute downhill running
15998692|NCT02899637|Device|Active high-frequency Transcranial Magnetic Stimulation|Active intervention, 5Hz on the lower limbs area of the motor cortex, during one week
15998693|NCT02899637|Device|Sham high-frequency Transcranial Magnetic Stimulation|Sham intervention, 5Hz on the lower limbs area of the motor cortex, during one week
15998694|NCT02899624|Biological|Extra blood draw samples|
15998695|NCT02899624|Biological|additional tissue samples|
15998696|NCT02899611|Drug|Valproate|ICV Valproate is a dilution of the commercially available Epilim product, which is a sterile intravenous (IV) formulation of Sodium Valproate.
15998697|NCT02899598|Biological|Extra blood draw samples|
15998698|NCT02899598|Biological|extra amniotic fluid samples|
15998699|NCT02899585|Other|Questionnaires|
15998700|NCT02899585|Other|Score|
15998701|NCT02899572|Procedure|Sexology consultation|a sexology consultation is planned in the 15 days after inclusion
15998702|NCT02899559|Behavioral|Message|Participants will receive one of three messages at the end of a survey, two of which are experimental messages and one of which is a control message.
15998703|NCT02899533|Drug|[18F] FES|[18F] FES PET/CT scan, imaging tracer
15998704|NCT02899520|Other|Reference method|Electrostimulation associated to perineal training
15998705|NCT02899520|Other|CMP ® method|Method based on Knowledge and Control of Perineum
15998706|NCT02899507|Drug|Amoxicillin-Clavulanic acid|Patients without evidence of tracheobronchial aspiration were randomized to immediate prophylactic Amoxicillin-Clavulanic acid 1,2 gr/8h
15998707|NCT02899494|Other|Antenatal classes|
15998708|NCT02899494|Other|Physical and psychic preparation|
15998709|NCT02899481|Other|Transabdominal and transperineal ultrasound|Transabdominal ultrasound, for determining fetal head position, is performed with the pregnant women in supine position after bladder emptying, with the transducer placed transversely on the suprapubic region of the maternal abdomen. For the sonographic determination of the fetal descent we will perform a transperineal ultrasound achieved by placing the ultrasound transducer on the perineum in a mid sagittal position between the labia below the pubic symphysis.
15998710|NCT02899468|Device|BrightBrainer Virtual Reality (BBVR) Rehabilitation System|During the active treatment stage (3 sessions per week x 6 weeks), each BBVR therapy session will consist of a series of custom games targeting one or several cognitive domains of executive function, attention, short-term memory, working memory and language comprehension. In addition, the BBVR device incorporates uni- and bi-manual activities by having the subject manipulate hand-held devices, which are programmed to measure in real time the subject's 3D hand movement and index flexion/extension. Therefore, in addition to completing the cognitive tasks, subjects must manipulate virtual hands through a hand-held interface to also enhance visual-motor perception, hand-eye coordination, and upper limb function. In addition, wrist weights can be added to increase upper limb strength training.
15998711|NCT02899455|Drug|HGP0904|
15998712|NCT02899455|Drug|HGP0608|
15998713|NCT02899455|Drug|HGP0816|
15998714|NCT02899455|Drug|HGP0904 Placebo|
15998715|NCT02899455|Drug|HGP0816 Placebo|
15998716|NCT02899442|Other|collective prevention in workplace|From countermeasures referenced in guidelines, some tools were also created by the committee to standardize all preventive actions and to define measurable indicators. A specific monitoring for checking their applicability and for evaluating the duration of implementation is planned.Collective actions are classified in 7 categories:1)Standardized information of night work risk on health and countermeasure to prevent them, 2)Acknowledgement of the existence of the risk, thereby helping to raise general awareness, 3)Improvement of characteristics of night work (rhythm, rest, time to start and to end, schedule forecasted, duration of night work),4)Improvement of related conditions at night work (Job strain, monotonous or repetitive tasks, manager's help, collective co-operation; Light environment; Occupational physical activities, 5)Sleep improvements ,6)Improvement of dietetic intakes at work, 7)Improvement of leisure physical activity's practice within the work site
15998717|NCT02899403|Other|Rapid Visual Information Processing (RVIP) test|Rapid Visual Information Processing is a measure of sustained attention.
15998718|NCT02899390|Behavioral|Lifestyle Intervention|"Before implementation of the National Diabetes Prevention Program, adaptations will be made in order to be culturally acceptable in the community taking in consideration the type of food they eat and their activities in the population.
~The lifestyle intervention will be implemented by group and individual sessions and is aimed at achieving a 7% loss weight from baseline and 150 minutes per week of physical activity. Sessions will be held weekly in a period of 6 months. Individual sessions consist in nutritional counseling according to energy needs and food preferences of each participant."
15998719|NCT02899377|Radiation|18F-FDG PET/CT Imaging|pSS subjects (in fasting conditions) will receive one-time bolus IV injection of 200 MBq of 18F-FDG. After 60 minutes of administration, a PET scan will be performed with static scanning acquired for up to 30 to 40 minutes.Other name: 18F-FDG
15998720|NCT02899377|Radiation|11C-MET PET/CT Imaging|"Subjects (post meal) will receive one-time bolus IV injection of 500 MBq of 11C-MET. This will be followed by PET scan and dynamic scanning of the salivary gland region for approximately 40 minutes. A static scan will then be performed (within 5 minutes) with the whole body CT followed by the PET covering the head to hip with a duration of same range for approximately 20 to 30 minutes.
~Other Name:11C-MET"
15998721|NCT02899377|Procedure|MRI Imaging with intravenous contrast with gadoterate meglumine|Eligible subjects will receive a one-time IV injection of 0.1mmol/kg of gadoterate meglumine followed by a multi-parametric MRI scanning.
15998722|NCT02899377|Procedure|Minor Salivary gland (labial) biopsy|A minor salivary gland biopsy will be performed at Visit 2 for pSS subjects only.
16067616|NCT02400411|Other|rye bread|
15998724|NCT02899364|Drug|Sodium chloride 0.9%|see description under placebo comparator arm
15998725|NCT02899364|Procedure|primary percutaneous coronary intervention|Primary treatment of the ischemia-related coronary artery is left to discretion of the operator and might consist of thrombus aspiration, balloon inflation and stent implantation. Additional balloon angioplasty or stenting of the culprit or other lesions will be performed when necessary.
15998726|NCT02899364|Other|cardiac magnetic resonance imaging|CMR-imaging will be used for assessment of infarct size, left ventricular function, quantification of myocardial scar and diffuse myocardial fibrosis. CMR-imaging examinations will be performed on a 3 Tesla scanner using a phased array cardiac receiver coil at 4 months after randomization according to standard protocols. The full study protocol lasts approximately 45 minutes and includes anatomy and function, LGE and T1-mapping.
15998727|NCT02899351|Device|Respiratory Volume Monitor|
15998728|NCT02899338|Drug|BI695501 Prefilled syringe|
15998729|NCT02899338|Drug|BI695501Autoinjector|
15998730|NCT02899325|Drug|Diagnostic PET/CT scans|These PET/CT scans will be performed for diagnostic purposes of hepatocellular carcinoma.
15998731|NCT02899312|Drug|PSMA PET/CT scan|"All participants will undergo the same procedures listed in Detailed Description in the protocol section."
15998732|NCT02899299|Biological|Nivolumab|
15998733|NCT02899299|Biological|Ipilimumab|
15998734|NCT02899299|Drug|Pemetrexed|
15998735|NCT02899299|Drug|Cisplatin|
15998736|NCT02899299|Drug|Carboplatin|
15998737|NCT02899286|Biological|PEG-BCT-100|PEGylated recombinant human arginase
15998738|NCT02899260|Device|Peanut Exercise Ball|A Peanut shaped exercise ball.
15998739|NCT02899247|Procedure|Surface sealant|"Device:
~Enamel and dentin etching with 37% phosphoric acid (Scotchbond Etchant; 3M/ESPE, St. Paul, MN, USA) for 30 s and 15 s.
~Two coats of one-bottle adhesive (Adper TM Single Bond 2, 3M/ESPE, St. Paul, MN, USA) will be applied homogeneously to the surface with a disposable micro-brush.
~Cavities will be restored with 2 mm increments of composite resin (Z350, 3M/ESPE, St. Paul, MN, USA)
~7 Days after: Finishing and polishing will be performed with fine diamond and multilaminated burs, one step polishing system Pogo (Dentsply, Caulk, USA).
~The composite surface and 1 mm external limit will be etched with a 37% acid phosphoric and after will be covered using a nanotechnology liquid polish system (Lasting Touch, Dentsply Caulk, Milford, DE, USA)."
15998740|NCT02899247|Procedure|No surface sealant|"Device:
~Enamel and dentin etching with 37% phosphoric acid (Scotchbond Etchant; 3M/ESPE, St. Paul, MN, USA) for 30 s and 15 s.
~Two coats of one-bottle adhesive (Adper TM Single Bond 2, 3M/ESPE, St. Paul, MN, USA) will be applied homogeneously to the surface with a disposable micro-brush.
~Cavities will be restored with 2 mm increments of composite resin (Z350, 3M/ESPE, St. Paul, MN, USA)
~7 Days after: Finishing and polishing will be performed with fine diamond and multilaminated burs, one step polishing system Pogo (Dentsply, Caulk, USA)."
15998741|NCT02899234|Other|E-cigarette|A third generation e-cigarette device will be used with pre-determined temperature, voltage and wattage settings.
15998742|NCT02899221|Radiation|High-Dose Rate Brachytherapy|Undergo high dose rate brachytherapy
15998743|NCT02899221|Procedure|Hyperthermia Treatment|Undergo interstitial hyperthermia treatment
15998744|NCT02899195|Drug|Durvalumab|On Day 1 of each 21 day cycle: Durvalumab 1120 mg IV will be administered before pemetrexed and cisplatin chemotherapy over approximately 60 minutes. Approximately 30 minutes after the durvalumab infusion is complete, pemetrexed 500 mg/m² IV will be administered over 10 minutes. Cisplatin 75 mg/m² IV over 2 hours will begin approximately 30 minutes after the end of pemetrexed administration. If carboplatin is substituted for cisplatin, carboplatin Area Under the Concentration-Time Curve (AUC) 5 will be infused over 30 minutes beginning approximately 15-30 minutes after the end of the pemetrexed administration. Maintenance: On Day 1 of each 21 day cycle: Durvalumab 1120 mg IV over approximately 60 minutes.
15998745|NCT02899182|Drug|Nitrous Oxide NO|The NO group receive local anesthesia at the puncture site plus inhalation N2O-O2 mixture by self-demand valve
15998746|NCT02899182|Other|O2|the conventional group (C) will receive local anesthesia at the puncture site plus inhalation of 100% oxygen a face mask.
15998747|NCT02899169|Drug|Realgar-Indigo naturalis formula|
15998748|NCT02899169|Drug|all-trans retinoic acid|
15998749|NCT02899169|Drug|Arsenic trioxide|
15998750|NCT02899169|Drug|Hydroxyurea|
15998751|NCT02899156|Drug|Flumazenil|
15998752|NCT02899156|Drug|Placebo|0.9% normal saline
15998753|NCT02899143|Drug|Antibiotic|Targeted antimicrobial therapy
15998754|NCT02899130|Drug|Polyherbal|Each capsule contains 3 herbs. Phyllanthus niruri, Boerhaavia diffusa, picrorhiza kurroa
15998755|NCT02899130|Drug|Placebo|Inactive compound that is similar looking as the intervention
15998756|NCT02899117|Other|Yoga|There are 4 yoga sessions completed with a certified instructor during cancer treatment
15998757|NCT02899104|Drug|Xofigo (Radium-223 dichloride, BAY88-8223)|Xofigo is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC), symptomatic bone metastases and no known visceral metastatic disease.
15998758|NCT02899091|Biological|CB-AC-02|"Stage1:
~① Group1: CB-AC-02, 2.0 x 10^8 cells on day 0
~② Group2: CB-AC-02, 2.0 x 10^8 cells, on day 0 and on week 4 (repeated injection)
~Stage2
~① Arm1: K-MMSE 20~26 CB-AC-02, 2.0 x 10^8 cells on day 0 and on week 4 (repeated injection)
~② Arm2: K-MMSE 10~19 CB-AC-02, 2.0 x 10^8 cells on day 0 and on week 4 (repeated injection)"
15998759|NCT02899091|Biological|Placebo|"Stage2:
~Placebo on day 0 and on week 4 (repeated injection)"
15998760|NCT02899078|Drug|Ibrutinib|Given PO
15998761|NCT02899078|Drug|Nivolumab|Given IV
15998762|NCT02899065|Diagnostic Test|Procalcitonin|Procalcitonin is a blood test used to differentiate between viral and bacterial infections. This test is expected to aid in determining the best course of treatment for patients enrolled into this arm.
15998763|NCT02899065|Other|Pharmacist-Led Education|Pharmacists will interpret the results of the Roche Cobas Liat Flu/RSV assay and procalcitonin test (if available) and provide the treating physician with recommendations for antibiotic therapy based on these results.
15998831|NCT02898441|Device|Low Dose Computed Tomography|LDCT were performed in screening arm. The abnormal nodules were defined as noncalcified nodules (NCN) larger than 4 mm.
15998832|NCT02898428|Device|Continuous glucose monitoring (CGM)|
15998833|NCT02898415|Procedure|Liver transplantation|
15999041|NCT02897050|Drug|Cyclophosphamide (tablet)|Cyclophosphamide 50 mg/d, po, d1-d21
15998767|NCT02899039|Biological|extra blood draw samples|
15998768|NCT02899026|Drug|Sirukumab|Sirukumab will be provided as 1 millilitre (mL) Pre-filled Syringe (PFS), containing 100 mg/mL or 50 mg/mL of sirukumab, fitted with a spring-powered, disposable autoinjector device for single use SC administration of liquid biologic drug
15998769|NCT02899026|Drug|Placebo to match sirukumab|Placebo to match sirukumab will be provided as 1.0 mL PFS fitted with a spring-powered, disposable autoinjector device for single use SC administration of liquid biologic drug
15998770|NCT02899026|Drug|Prednisone /Prednisone placebo|Prednisone will be provided as tablets with dosage level up to 20 mg/day. All subjects will receive 20 mg prednisone at Baseline (Randomization) and follow predefined taper regimen (6 weeks or 52 weeks) based on treatment assignment. Placebo to match prednisone will be provided as tablets
15998771|NCT02899013|Other|No intervention|Observational study to describe Perianal Lesions in a Cohort of Crohn's Disease Patients.
15998772|NCT02899000|Drug|Adapalene 0.3% / benzoyl peroxide 2.5% emulsion gel|Topical acne therapy
15998773|NCT02899000|Drug|Oral doxycycline hyclate|Tetracycline-class oral antibacterial 200 mg daily (2 tablets [50 mg], twice daily)
15998774|NCT02898974|Behavioral|Medical Marijuana|To investigate the effects of medical marijuana usage on physical function we will employ an observational case-control design
15998775|NCT02898961|Drug|30 mg/kg amikacin or 8 mg/kg gentamicin|"In order to improve the achievement of target peak concentrations, either 30 mg/kg amikacin or 8 mg/kg gentamicin was prescribed in ICU patients with severe sepsis.
~In combination with broad-spectrum antibiotics, according to the suspected pathogens and local clinical practice, 30 mg/kg amikacin or 8 mg/kg gentamicin was given (30 min intravenous infusion; the dosage ampoule was systematically emptied with a 5 ml flush). The peak serum concentration sampling occurred 30 minutes after the end of the infusion."
15998776|NCT02898948|Biological|Procalcitonin (PCT) as a diagnostic marker of bacterial infection|
15998777|NCT02898922|Biological|hepatitis B vaccine made by Recombinant DNA Techniques in Saccharomyces Cerevisiae|20 μg HBsAg/1.0ml per dose, Shenzhen Kangtai Biological Products Co., Ltd., Shenzhen, Guangdong Province, China
15998778|NCT02898909|Device|nuclear lens fragmentation in 8 pieces|
15998779|NCT02898909|Device|nuclear lens fragmentation in 16 pieces|
15998780|NCT02898896|Biological|blood test|Additional 21 ml of blood will be collected
15998781|NCT02898883|Behavioral|Building Resilience after Childhood Emergencies (BRACE)|See arm/group description for details regarding this intervention
15998782|NCT02898857|Other|biopsies|The biopsies of lung tumour samples will be analysed by immunochemistry (IHC), western blotting and qPolymerase Chain Reaction (PCR) approaches in Six with demonstrated down-staging of a KRAS mutant adenocarcinoma, Six with demonstrated no down-staging (persistent tumour cell involving lymph nodes in surgically resected specimens) of a KRAS mutant adenocarcinoma and Six with or without non-staging and triple negative adenocarcinoma
15998783|NCT02898844|Behavioral|Mixed Diet Condition|One roommate dieted and the other ate normally.
15998784|NCT02898844|Behavioral|Both Diet Condition|Both roommates dieted.
15998785|NCT02898831|Other|Cold Compress|Cold Compress placed on lower abdomen prior to and during IUD insertion.
15998786|NCT02898818|Other|vaginal and oral swab sample, questionnaire|vaginal and oral swab sample and questionnaire
15998787|NCT02898818|Other|papa smear|Papnicolaou Papa Smear test
15998788|NCT02898805|Other|Placebo|
15998789|NCT02898805|Other|Prescribed Diet|
15998790|NCT02898805|Dietary Supplement|LopiGLIK®|
15998791|NCT02898805|Dietary Supplement|Armolipid Plus|
15998792|NCT02898792|Drug|Targeted infusion of remifentanil|Remifentanil dosing will be calculated using ideal body weight and infused to achieve brain concentrations of 0.5, 1, 2, 3, and 4 ng/ml; approximately 10 minutes at each concentration.
15998793|NCT02898779|Drug|Primaquine, R-Primaquine, S-Primaquine, SR Primaquine|"Cohort 1: Eighteen individuals (6 per group) Cohort 2: Eighteen individuals (6 per group)
~Group 1-15 mg of S-Primaquine followed by one-week washout, 15 mg of R-Primaquine followed by one week washout, and 30 mg of RS-Primaquine.
~Group 2- 15 mg of R-Primaquine followed by one-week washout, 30 mg of RSPQ followed by one week washout, and 15 mg of SPQ.
~Group 3- 30 mg of RS-Primaquine followed by one week washout,15 mg of SPQ followed by a one week washout, and 15 mg of RPQ."
15998794|NCT02898766|Other|Enteral Nutrition Formula|
15998795|NCT02898753|Drug|VAL-1221|VAL-1221 3, 10, or 30 mg/kg as per the dose and schedule specified in the arm group description
15998796|NCT02898753|Drug|RhGAA|Active comparator
15998797|NCT02898740|Behavioral|Structural exercise|Exercise instruction and encouragement
15998798|NCT02898740|Behavioral|Health education|Provision of general information about a variety of health topics
15998799|NCT02898727|Other|Local Therapy|"Neurosurgery: The decision whether or not to recommend neurosurgery will be made independently of this research study. The complexity and length of the surgery depends on the size and location of the tumour(s).
~Stereotactic Radiosurgery: If the participant will be receiving stereotactic radiosurgery (either alone or in combination with neurosurgery), the Radiation Oncologist will organise for the participant to have a Radiotherapy planning. Single metastasis, smaller than or equal to 2cm, may require 1 fraction. Alternately, multiple metastasis, metastasis in the brain stem, or those bigger than 2cm will required multiple fractions to treat. The dose range for the study is 20Gy/1 fraction to 24Gy/3 fractions."
15999042|NCT02897050|Drug|Fluorouracil|Fluorouracil 500mg/m2, iv, d1
15998800|NCT02898701|Behavioral|Motor Practice of a Standing Serial Reaction Time Task|Subjects will perform a standing serial reaction time task on a step reaction mat. Subjects will step to a series of targets, based on a series of stimuli that are presented. One trial is composed of two 12-step sequences. One of the 12-step sequences is random, while the other is a repeated sequence; sequences are presented in random order. After each trial, the subject rests for 25 seconds. Six trials equal 1 block of practice, which is followed by a 4 minute rest break. After each block, feedback is provided about average response time (RT) on all steps included in the block. One complete day of practice consists of 6 blocks of practice in which each block consists of 6 trials.
15998801|NCT02898688|Behavioral|Control Site|Control sites will continue with their standard practice regarding discussing vaccines with their patients.
15998802|NCT02898688|Behavioral|Intervention Site|Intervention Sites will each assign a Vaccine Champion and will have Assessment, Feedback, Incentives, and eXchange (AFIX) visits. AFIX is a quality improvement program to raise immunization coverage levels, reduce missed opportunities to vaccinate, and improve standards of practices at the provider level. A Continuing Medical Education (CME) module will be given to all providers, covering the recommended maternal vaccinations and how to talk to patients about vaccines. Intervention sites will have access to written materials covering all recommended maternal and infant vaccinations, the diseases they prevent, potential adverse reactions and common patient questions with talking points and references for each topic.
15998803|NCT02898688|Behavioral|Patient-level Control Group|"Participants randomized the control arm will complete a computer-based questionnaire, on an iPad with a preloaded app. The questionnaire asks about vaccine knowledge, attitudes, and beliefs and the participant's intent to receive vaccinations during pregnancy and to vaccinate their baby. The questionnaire includes questions requiring a yes or no response, degree of agreement with vaccine-related statements (ranging from strongly agree to strongly disagree), questions to capture the vaccines participants plan to get for themselves and their children, and open-ended questions."
15998804|NCT02898688|Behavioral|Patient-level Intervention Group|"Participants randomized to the intervention arm will complete a computer-based questionnaire on an iPad with a preloaded app, prior to watching informational videos covering topics on maternal and childhood vaccines. The questionnaire asks about vaccine knowledge, attitudes, beliefs, and the participant's intent to receive vaccinations during pregnancy and to vaccinate their baby. The questions require yes or no responses, degree of agreement with vaccine-related statements (ranging from strongly agree to strongly disagree), and open-ended responses. After watching at least one informational video, the participant completes a questionnaire asking about the perceived usefulness of the app, degree of agreement with the vaccine information presented in the video, and ways to make the app more useful to participants."
15998805|NCT02898675|Device|Platelet rich fibrine|Platelet rich fibrin increases the growth factors. So it was applied for treatment of periodontal bone loss.
15998806|NCT02898675|Device|Open Flap Debridement|Only open flap debridement treatment the bone loss limitedly
15998807|NCT02898662|Drug|AZD1419|Inhaled AZD1419 administered at the clinic as once weekly inhalations with the I-neb® device. Start dose is 4 mg and dose adaptation is applied (downtitration to 1mg or uptitration to 8 mg or remain on 4 mg) based on appearance of flu like adverse events
15998808|NCT02898662|Drug|Placebo|Inhaled Placebo administered at the clinic as once weekly inhalations with the I-neb® device. Start dose is Placebo 4 mg and dose adaptation is applied (downtitration to 1mg or uptitration to 8 mg or remain on 4 mg) based on appearance of flu like adverse events
15998809|NCT02898649|Device|Irreversible electroporation|IRE is operated to tumor under laparotomy or CT-guided percutaneous approach. Unipolar (19G) or bipolar (16G) electrode probe is inserted to around tumor. After insertion of probe, short duration (70-90㎲) of electric current (25~45A) is generated by IRE device (NanoKnife IRE device, AngioDynamics, Queens bury, New York). It is possible to obtain a three-dimensional ablation zone using multiple electrode. IRE can cause apoptosis of tumor cells, without adjacent tissue damage.
15998810|NCT02898636|Other|autopsy|At autopsy achieving adequate sampling of lesions and healthy skin
15998811|NCT02898623|Other|No intervention|Evaluation of performance of immunoassays based on the detection of antibodies directed against Mycobacterium tuberculosis antigen
15998812|NCT02898610|Drug|Colchicine|
15998813|NCT02898597|Behavioral|Cognitive Behavioral Therapy|Received 8 weekly individualized counseling sessions of cognitive behavioral therapy
15998814|NCT02898584|Other|BP Track|
15998815|NCT02898571|Dietary Supplement|Placebo|Placebo comparitor
15998816|NCT02898571|Dietary Supplement|Vitamin C|Active treatment
15998817|NCT02898571|Dietary Supplement|epicatechin|Active treatment
15998818|NCT02898558|Behavioral|Magnification hand size|Participants will use magnifying lenses while completing a jigsaw puzzle for 30 min a day for 14 days.
15998819|NCT02898558|Device|magnifying lenses|
15998820|NCT02898545|Device|SEEQ monitor|An external cardiac rhythm monitor
15998821|NCT02898532|Behavioral|Educational programmes|Children with ADHD or ADHD-like symptoms practicing target shooting sport in Danish Shooting Associations, during schooltime, for 6 months.
15998822|NCT02898519|Other|cohort|Blood sampling
15998823|NCT02898506|Drug|Victoza®|Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months and thereafter follow-up of 6 months.
15998824|NCT02898506|Drug|Placebo|Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months and thereafter follow-up of 6 months.
15998825|NCT02898480|Procedure|Remote ischemic conditioning|Briefly reversible restricting of blood flow to upper limb in four cycles of 5 minutes of inflation at 200mm Hg followed by 5 minutes of deflation.
15998826|NCT02898467|Other|diabetics|additional blood and urine collection during usual medical care endarterectomy samples during usual medical care
15998827|NCT02898467|Other|non-diabetics|additional blood and urine collection during usual medical care endarterectomy samples during usual medical care
15998828|NCT02898454|Drug|Dupilumab SAR231893 (REGN668)|"Pharmaceutical form: Solution
~Route of administration: Subcutaneous"
15998829|NCT02898454|Drug|Placebo|"Pharmaceutical form: Solution
~Route of administration: Subcutaneous"
15998830|NCT02898454|Drug|Mometasone furoate nasal spray|"Pharmaceutical form: Suspension
~Route of administration: Intranasal"
15999043|NCT02897050|Drug|Epirubicin|Epirubicin 100mg/m2, iv, d1
16067667|NCT02400099|Other|Liver biopsy|
15998834|NCT02898402|Procedure|blood sample and questionnaire|In addition to normal blood sample performed at entry before delivery, an extra 5 ml blood sample will be taken to establish Q fever serodiagnosis and a short questionnaire will be filled in for clinical and epidemiological data.
15998835|NCT02898376|Other|skin-oriented spa care|"standardized procedure : 72 care sessions over 18 days of treatment
~+/- Additional care according to the specificity of each spa"
15998836|NCT02898376|Drug|Pentoxifylline|400 mg bid during at least 6 months
15998837|NCT02898376|Drug|Tocopherol acetate|500 mg bid during at least 6 months
15998838|NCT02898363|Other|Information campaign|During a two-year information program, physicians, mainly general practitioners, carers in and outside institutions, associations and families will be informed on cancer frequency, on cancer particularities and on cancer detection in persons with intellectual disabilities by means of documents, mails and e-mails, meetings and a website providing all available useful information on cancer in persons with intellectual disabilities.
15998839|NCT02898350|Device|Pulsed dye laser treatment|Scar minimization with Pulsed dye laser treatment on suture removal day
15998840|NCT02898350|Device|CO2 laser treatment|Scar minimization with CO2 laser treatment on suture removal day
15998841|NCT02898350|Device|Combined PDL and CO2 laser treatment|Scar minimization with Pulsed dye laser and CO2 laser treatment on suture removal day
15998842|NCT02898350|Device|Split PDL and CO2 Laser treatment|Split-scar with CO2 treatment after surgery and combined PDL and CO2 treatment on suture removal day
15998843|NCT02898337|Device|AliveCor handheld mobile ECG|"Specific Aim 1: independent risk factors for methadone-associated QTc interval prolongation will be determined through retrospective analysis of electronic medical records of methadone-treated patients in a narcotic treatment center. Patients will be asked to come to the Narcotic Treatment Center for one 12-lead ECG
~Specific Aim 2: QTc intervals from ECGs generated by the AliveCor® heart monitor will be compared prospectively to simultaneous twelve lead ECGs for validation purposes in the methadone-treated patients in a narcotic treatment center."
15998844|NCT02898324|Other|KiVa program|KiVa program is an anti-bullying intervention developed in University of Turku, Finland. It is based on the participant role model, where bullying is seen as a group process focused on the bystanders' reactions to the bullying. This program includes universal and indicated actions. Universal actions include ten students lessons given by teachers where pupils learn the role of bystanders in the bullying process, how to increase empathy towards the victim, and safe strategies to supports victims. Indicated actions are delivered by a school team of three staff members, who handle acute cases of bullying.
15998845|NCT02898311|Device|immediate loading of posterior implants with chairside CAD-CAM composite crown|
15998846|NCT02898298|Behavioral|Positive Emotion Regulation Training|Participants will receive a 3-session psycho-educative training on emotion regulation.
15998847|NCT02898285|Behavioral|Team sports|Participants will choose from a list of team sports and will be signed up with the team.
15998848|NCT02898285|Behavioral|Individual sport condition|Participants will choose from a list of individual sports.
15998849|NCT02898285|Behavioral|Night out|"Participants in this group will be asked to go out to have a weekly night out or personal time of choice, such as dinner or a movie (only restrictions are they cannot go do a sport or physical activity and time must be spent without children)."
15998850|NCT02898259|Drug|Ixazomib|The prescribed administration of ixazomib doses in this study is 2.0, 3.0 or 4.0 mg ixazomib on days 1, 8 and 15 of each 28 day cycle.
15998851|NCT02898259|Drug|Lenalidomide|"Lenalidomide starting dose will be based on baseline calculated creatinine clearance as follows:
~Starting lenalidomide Dose (20mg)
~Calculated Creatinine Clearance: >=60ml/min receive 20 mg daily on Days 1 - 21 of each 28-day cycle
~Calculated Creatinine Clearance: >= 30 and < 60 ml/min receive 10 mg daily on Days 1 - 21 of each 28-day cycle"
15998852|NCT02898259|Drug|Rituximab|Rituximab is administered intravenously at 375mg/m2 on days 1, 8, and 15 of cycle 1, day 1 of cycles 2-6 and day 1 of cycles 8, 10, and 12.
15998853|NCT02898233|Other|Deprexis|Deprexis is an experimental internet-based treatment program for depression created by Gaia (Hamburg, Germany).
15998854|NCT02898233|Device|Active low-level light therapy|Administration of LLLT consists of applying light of a specific wavelength (1064 nanometers) that intersects with the absorption spectrum of cytochrome oxidase, using a laser diode, the high density laser (HD laser; Cell Gen Therapeutics, LLC). Active LLLT includes 4 days, once per week for 4 weeks, during which LLLT is applied to two alternating positions on the participant's right forehead for 8 minutes total.
15998855|NCT02898233|Device|Sham low-level light therapy|Administration of LLLT consists of applying light of a specific wavelength (1064 nanometers) that intersects with the absorption spectrum of cytochrome oxidase, using a laser diode, the high density laser (HD laser; Cell Gen Therapeutics, LLC). Sham LLLT includes 4 days, once per week for 4 weeks, during which sham LLLT (5 seconds active, 55 seconds sham) is applied to two alternating positions on the participant's right forehead for 8 minutes total.
15998856|NCT02898207|Drug|Olaparib|Given PO
15998857|NCT02898207|Drug|Onalespib|Given IV
15998858|NCT02898181|Device|Tragus stimulation|Active LLTS will be performed by use of a transcutaneous electrical nerve stimulation (TENS) device with electrodes attached to the tragus of the ear.TENS will be applied continuously for 8 hours daily (4 hours twice daily)
15998859|NCT02898168|Device|WA group|Conventional rehabilitation therapy and gait training with WAIntervention with WA is scheduled 40min/day, five times a week, for 8 weeks.
15998860|NCT02898168|Other|Control|Conventional rehabilitation therapy and gait training without WA.
15998861|NCT02898155|Other|measure of access to primary care and of the Interface Between Primary ans Secondary Care|
15998862|NCT02898142|Other|Postprandial test|Postprandial test : The preparation used for this test consists of a semi standardized liquid meal (400 ml energy drink Fresubin® 2 cal / ml, Fresenius Kabi, France), containing 800 kcal, 50% calories from carbohydrates, 15% in as protein, and 35% as lipid. The test meal will be performed in the morning during 6 hours (between 8:00 and 14:00) after 10 hours of fasting. This post prandial test is the same in the two study groups.
15998863|NCT02898129|Other|Questionnaire|
15998864|NCT02898129|Device|Lung function test|Basic lung function test performed with a micro-spirometer, without broncho dilatator
15998950|NCT02897713|Other|intensive enteral nutrition|After recruitment, patients should be assessed for EN initiation during first 24 hours after ICU admission. 80% of energy target should be reached within 72 hours.
15998865|NCT02898116|Drug|Ensartinib|Ensartinib was administered orally once daily at a dose of 200 mg during the Run-in Period. During combination therapy, the ensartinib starting dose was to be 200 mg. Based on observed toxicity at the starting dose level, the ensartinib dose may have been escalated to the recommended single-agent dose (225 mg) or de-escalated to the minimum effective dose (150 mg).
15998866|NCT02898116|Drug|Durvalumab|During combination therapy, durvalumab was to be administered as an IV infusion over 60 (± 5) minutes every 4 weeks at a dose of 1500 mg.
15998867|NCT02898103|Device|Percutaneous peripheral nerve stimulation|Active electrical stimulation for 5 minutes in the recovery room
15998868|NCT02898103|Device|Sham stimulation|Sham (placebo) stimulation for 5 minutes in the recovery room
15998869|NCT02898103|Device|Percutaneous peripheral nerve stimulation|Active electrical stimulation for 2-4 weeks at home
15998870|NCT02898077|Drug|Ramucirumab|Administered IV
15998871|NCT02898077|Drug|Paclitaxel|Administered IV
15998872|NCT02898077|Drug|Placebo|Administered IV
15998873|NCT02898064|Device|thoracolumbosacral orthosis or cervicothoracolumbar orthosis|"An off the shelf spinal brace which will be applied to the patients trunk. They will have straps and harnesses which the patient can fasten and remove if needed. The brace will need to be worn by the intervention group all the time for 3 months except when lying in bed. In the presence of lower thoracic (T8 downwards), thoraco-lumbar and lumbar (L1- L3) fractures, a thoracolumbosacral orthosis will be applied. For upper thoracic fractures (T1-T7) a cervico-thoracic or cervico-thoraco-lumbar orthosis will be used."
15998874|NCT02898064|Other|Standard care|Standard surgery, radiotherapy, chemotherapy, drug therapy as applicable and decided by the participants consultant as part of standard care
15998875|NCT02898038|Dietary Supplement|AYMES PARIS|AYMES PARIS is a powdered, high energy, oral nutritional supplement to be mixed with milk as a drink. It provides 320 kcal and 12.2 g protein per 139 ml serving. It is a Food for Special Medical Purposes (FSMP) and must, therefore, be used under medical supervision. It is not designed as a sole source of nutrition.
15998876|NCT02898025|Device|Active Interferential Current|Involves the application of medium frequency alternating currents
15998877|NCT02898025|Device|Active Laser|Involves the application of low level laser over the knee
15998878|NCT02898025|Device|Placebo Interferential Current|It is a sham interferential therapy
15998879|NCT02898025|Device|Placebo Laser|It is a sham laser therapy
15998880|NCT02898012|Drug|Temozolomide|Temozolomide (TMZ) Temozolomide (TMZ) administered at 130-150 mg/m2 for 5 consecutive days every 4 weeks up to 12 cycles. IV or oral administration was allowed according to the clinical status. TMZ starts at 130 mgs/m2 and increase to 150 mgs/m2 during the second cycle in the absence of hematologic toxicity. In the case of grade 3 or 4 toxicity, the dose for the next cycle is decreased to 110 mg/m2. If the grade 3 or 4 toxicity persists at a dose of 110 mg/m2, treatment is discontinued.
15998881|NCT02898012|Drug|Bevacizumab|Bevacizumab (Bev) administered at a dose of 10 mgs/kg every 2 weeks. Bev was interrupted in cases of wound healing disturbances, gastrointestinal perforation, intestinal occlusion, fistula, uncontrolled hypertension, nephrotic syndrome, grade 4 or recurrent grade 3 thromboembolic events, arterial thrombosis, hemorrhage > grade 2, left ventricular failure, or posterior reversible leukoencephalopathy.
15998882|NCT02897999|Biological|QBKPN|QBKPN Site Specific Immunomodulators
15998883|NCT02897999|Other|Placebo|Placebo
15998884|NCT02897986|Drug|administration of a propranolol (HEMANGIOL®) and oral metronomic vinorelbine (NAVELBINE®) combination|
15998885|NCT02897973|Other|Activity of daily living|walking, sitting-to-standing and standing-to-sitting, stairs ascending and descending
15998886|NCT02897947|Procedure|Surgery for lumbar spinal stenosis in Norway|
15998887|NCT02897947|Procedure|Surgery for lumbar spinal stenosis in Sweden|Surgery for neurogenic claudication due to lumbar spinal stenosis in Sweden
15998888|NCT02897947|Procedure|Surgery for lumbar spinal stenosis in Denmark|Surgery for neurogenic claudication due to lumbar spinal stenosis in Denmark
15998889|NCT02897934|Drug|Bupivacaine continuous infusion|The use of continuous wound infusion of bupivacaine
15998890|NCT02897908|Procedure|vibration controlled transient elastography (VCTE)|Once on the examination table, the subject will be instructed to place the right arm under their head and to cross their right ankle over the left ankle. The subject will then be asked to slightly bend to the left side to open the intercostal space. Subsequently, a handheld probe is placed in the intercostal space overlaying the right hepatic lobe. The velocity of returning shear waves, measured at a depth of 25-65 mm, is converted into a liver stiffness measurement (LSM). The LSM obtained from a given VCTE exam is the median value of at least 10 successful measurements. This information, along with clinical data associated with the patient will be placed in a database for use in identifying potential subjects for future trials.
15998891|NCT02897895|Biological|levels of CNI in whole blood|
15998892|NCT02897895|Biological|Calcineurin activity (CN-a) in peripheral blood mononuclear cells (PBMCs)|
15998893|NCT02897882|Other|Lung transplant|Pain evaluation
15998894|NCT02897869|Drug|POL7080|7 doses of POL7080 alone over 2.5 days
15998895|NCT02897869|Drug|Amikacin|3 doses of Amikacin alone over 2.5 days
15998896|NCT02897869|Drug|POL7080 + Amikacin|7 doses of POL7080 and 3 doses of Amikacin over 2.5 days
15998897|NCT02897856|Drug|Buccal midazolam|Study subject will receive Buccal midazolam, Intramuscular placebo.
15998898|NCT02897856|Drug|Intramuscular midazolam|Study subject will receive Intramuscular midazolam,Buccal placebo
15998899|NCT02897843|Device|transcranial magnetic stimulation|tDCS stimulation will involve ten 20 minute stimulations daily, characterized by 2 milliamps (mA) anode over the left dorsolateral prefrontal cortex (DLPFC), with the cathode placed over the right suborbital region.
15998900|NCT02897843|Device|sham tDCS|sham tDCS
15998901|NCT02897830|Drug|Ixazomib|"induction therapy: comprising three 28-day cycles with Ixazomib (4 mg) on Days 1, 8 and 15 plus Lenalidomide (25 mg) on Days 1 through 21 and Dexamethasone (40 mg) on Days 1, 8, 15 and 22.
~Early consolidation : (consolidation part 1) will start 2 months (-/+ 14 days) after transplantation and will comprise 2 cycles of MLN - Rd (MLN R identical to induction therapy but low dose of Dexamethasone 20mg/d once a week).
~Late consolidation (consolidation part 2) will consist in 6 additional 28-day cycles of Ixazomib (4 mg on Days 1, 8 and 15) plus Lenalidomide (25 mg on Days 1 through 21)."
15999034|NCT02897076|Drug|betamethasone 24 mg|
15999035|NCT02897076|Drug|12mg betamethasone +placebo|
15998902|NCT02897830|Drug|Lenalidomide|"induction therapy: comprising three 28-day cycles with Ixazomib (4 mg) on Days 1, 8 and 15 plus Lenalidomide (25 mg) on Days 1 through 21 and Dexamethasone (40 mg) on Days 1, 8, 15 and 22.
~Early consolidation : (consolidation part 1) will start 2 months (-/+ 14 days) after transplantation and will comprise 2 cycles of MLN - Rd (MLN R identical to induction therapy but low dose of Dexamethasone 20mg/d once a week).
~Late consolidation (consolidation part 2) will consist in 6 additional 28-day cycles of Ixazomib (4 mg on Days 1, 8 and 15) plus Lenalidomide (25 mg on Days 1 through 21).
~Maintenance therapy will start within 28 days after the last dose of Lenalidomide in last cycle of Late Consolidation: Lenalidomide 10 mg/d taken on Days 1 through 21 for thirteen 28-day cycles"
15998903|NCT02897830|Drug|Dexamethasone|"induction therapy: comprising three 28-day cycles with Ixazomib (4 mg) on Days 1, 8 and 15 plus Lenalidomide (25 mg) on Days 1 through 21 and Dexamethasone (40 mg) on Days 1, 8, 15 and 22.
~Early consolidation : (consolidation part 1) will start 2 months (-/+ 14 days) after transplantation and will comprise 2 cycles of MLN - Rd (MLN R identical to induction therapy but low dose of Dexamethasone 20mg/d once a week)."
15998904|NCT02897804|Behavioral|Knowledge alone|Increase knowledge related STIs, STI risk, alcohol impairment, condom use skills, alcohol use behavior tracking skills, testing & treatment services.
15998905|NCT02897804|Behavioral|Self-efficacy alone|Increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15998906|NCT02897804|Behavioral|Perceived benefits alone|Increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
15998907|NCT02897804|Behavioral|Perceived benefits and self-efficacy|Increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15998908|NCT02897804|Behavioral|Injunctive norms|Correct misperceptions regarding approval of alcohol misuse & sexual risk taking.
15998909|NCT02897804|Behavioral|Injunctive norms and self-efficacy|Correct misperceptions regarding approval of alcohol misuse & sexual risk taking and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15998910|NCT02897804|Behavioral|Injunctive norms and perceived benefits|Correct misperceptions regarding approval of alcohol misuse & sexual risk taking and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15998911|NCT02897804|Behavioral|Injunctive norms, perceived benefits, and self-efficacy|Correct misperceptions regarding approval of alcohol misuse & sexual risk taking; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15998912|NCT02897804|Behavioral|Descriptive norms alone|Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors.
15998913|NCT02897804|Behavioral|Descriptive norms and self-efficacy|Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15998914|NCT02897804|Behavioral|Descriptive norms and perceived benefits|Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
15998915|NCT02897804|Behavioral|Descriptive norms,perceived benefits,self-efficacy|Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15998916|NCT02897804|Behavioral|Descriptive and injunctive norms|Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors and correct misperceptions regarding approval of alcohol misuse & sexual risk taking.
15998917|NCT02897804|Behavioral|Descriptive norms, injunctive norms,self-efficacy|Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15998918|NCT02897804|Behavioral|Descriptive and injunctive norms, benefits|Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
15998919|NCT02897804|Behavioral|Descriptive and injunctive norms, benefits,efficacy|Correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and Increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15998920|NCT02897804|Behavioral|Expectancies alone|Decrease the expectation that alcohol is needed to have good sexual encounter.
15998921|NCT02897804|Behavioral|Expectancies and self-efficacy|Decrease the expectation that alcohol is needed to have good sexual encounter and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15998922|NCT02897804|Behavioral|Expectancies and Perceived Benefits|Decrease the expectation that alcohol is needed to have good sexual encounter and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
15998923|NCT02897804|Behavioral|Expectancies, perceived benefits, self-efficacy|Decrease the expectation that alcohol is needed to have good sexual encounter; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15998924|NCT02897804|Behavioral|Expectancies and injunctive norms|Decrease the expectation that alcohol is needed to have good sexual encounter and correct misperceptions regarding approval of alcohol misuse & sexual risk taking.
15998925|NCT02897804|Behavioral|Expectancies, injunctive norms, and self-efficacy|Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15998926|NCT02897804|Behavioral|Expectancies, injunctive norms, benefits|Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
15998927|NCT02897804|Behavioral|Expectancies, injunctive norms, benefits, efficacy|Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15998928|NCT02897804|Behavioral|Expectancies and descriptive norms|Decrease the expectation that alcohol is needed to have good sexual encounter and correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors.
15998929|NCT02897804|Behavioral|Expectancies, descriptive norms, and self-efficacy|Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15998930|NCT02897804|Behavioral|Expectancies, descriptive norms, and benefits|Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
15998931|NCT02897804|Behavioral|Expectancies,descriptive norms, benefits, efficacy|Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15998932|NCT02897804|Behavioral|Expectancies, descriptive and injunctive norms|Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; and correct misperceptions regarding approval of alcohol misuse & sexual risk taking.
15998933|NCT02897804|Behavioral|Expectancies, descr& injun norms, efficacy|Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15998934|NCT02897804|Behavioral|Expectancies, desc & injun norms, benefits|Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; and increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol.
15998935|NCT02897804|Behavioral|Expectancies,desc & injun norms,benefits,efficacy|Decrease the expectation that alcohol is needed to have good sexual encounter; correct misperceptions of prevalence of alcohol-induced sexual risk behaviors, alcohol use/misuse, and sexual risk behaviors; correct misperceptions regarding approval of alcohol misuse & sexual risk taking; increase perceived benefits to use protective behavioral strategies to reduce the negative consequences of engaging in sexual behaviors under the influence of alcohol; and increase self-efficacy to use protective behavioral strategies (e.g., condom negotiation skills) to reduce unprotected sex.
15998936|NCT02897791|Behavioral|written evaluations|answering questions about pictures and stories
15998937|NCT02897778|Drug|Entinostat|Single, supratherapeutic dose of entinostat given orally
15998938|NCT02897778|Other|Placebo|Single dose of Placebo containing inactive ingredients matching the appearance of the active product (entinostat).
15998939|NCT02897765|Biological|NEO-PV-01|Personal cancer vaccine
15998940|NCT02897765|Biological|Nivolumab|monoclonal antibody against PD1
15998941|NCT02897765|Other|Adjuvant|immune adjuvant
15998942|NCT02897752|Device|gait training with WA|Thirty seven units (1 unit=20 minutes) of gait training with WA by a physical therapist for the WA group for 4 weeks (+/- 1 week). Thirteen and 24 of the 37 units are training by a physical therapist and self-training, respectively.
15998943|NCT02897752|Other|usual gait training|Thirty seven units of usual gait training by a physical therapist for the UT group for 4 weeks (+/- 1 week). Thirteen and 24 of the 37 units are training by a physical therapist and self-training, respectively.
15998944|NCT02897739|Procedure|Magnetic resonance imaging|Cardiac MRI and short MRI following USPIO infusion
15998945|NCT02897739|Biological|Acute Inflammatory Activation study|Blood sampling for exploration of type and level of inflammatory response
15998946|NCT02897739|Radiation|PET CT|PET study for metabolic pathway study
15998947|NCT02897739|Behavioral|Psychological assessment|Assessment by a psychologist
15998948|NCT02897726|Drug|NVP-1402|Oral
15998949|NCT02897726|Drug|NVP-1402R|Oral
15998951|NCT02897713|Other|routine enteral nutrition|Attendings decide when and how EN should be administered according to guidelines from academic organizations, such as ESPEN or ASPEN.
15998952|NCT02897700|Drug|Single agent of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate|Procedure: Routine chemotherapeutic regimens using one out of cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM) as single agent was performed 30~60 days before surgery：cyclophosphamide 100mg/M2, doxorubicin 60mg/M2, epirubicin 100mg/M2, fluorouracil 500mg/M2, or methotrexate 50mg/M2.The agent was given on a regular route of IV administration on the 1st and 8th day of each cycle, 28 days per cycle, totally 6 cycles. Subsequently, there was a 30-day interval between the last cycle and radical surgery.
15998953|NCT02897700|Drug|cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM)|Procedure: Routine chemotherapeutic regimens using two agents from cyclophosphamide, doxorubicin, epirubicin, fluorouracil and methotrexate (CDEFM) as combinatorial treatment was performed 30~60 days before surgery：cyclophosphamide 100mg/M2, doxorubicin 60mg/M2, epirubicin 100mg/M2, fluorouracil 500mg/M2, or methotrexate 50mg/M2.The agents were given on a regular route of IV administration on the 1st and 8th day of each cycle, 28 days per cycle, totally 6 cycles. Subsequently, there was a 30-day interval between the last cycle and radical surgery.
15998954|NCT02897700|Drug|Placebo|Procedure: Routine placebo standardized in clinical oncology was provided to patients to replace any chemotherapeutic agent.
15998955|NCT02897687|Behavioral|Facebook Group|A closed, invite-only group within Facebook facilitated by an interprofessional team that not only reinforces skills, but also aims to promote bonds and a sense of community and connectedness between participants.
15998956|NCT02897687|Behavioral|Book Club Group|A topical book club group discussing Autism-related material conducted by a single healthcare professional.
15998957|NCT02897674|Dietary Supplement|Palm olein|two thirds of the 30% fat calories will come from palm olein
15998958|NCT02897674|Dietary Supplement|Interesterified palm olein|two thirds of the 30% fat calories will come from interesterified palm olein
15998959|NCT02897674|Dietary Supplement|soybean oil|two thirds of the 30% fat calories will come from soybean oil
15998960|NCT02897661|Procedure|WMT|Washed microbiota transplantation (WMT) through mid-gut
15998961|NCT02897661|Dietary Supplement|EEN|Exclusive enteral nutrition (EEN) through feeding tube
15998962|NCT02897648|Drug|Assessment of dermal administration of Beta-Lactams|Evaluation of Pharmacokinetic / Pharmacodynamic of dermal administration of Beta-Lactams
15998963|NCT02897635|Behavioral|Individualized Integrative Medicine Intervention|
15998964|NCT02897622|Other|Case management|Case management by Eira unit
15998965|NCT02897596|Drug|Grazoprevir 100 mg/d 8 weeks|Patients with 1b HCV genotype will be received treatment with Grazoprevir (100 mg) during 8 weeks.
15998966|NCT02897596|Drug|Elbasvir 50 mg/d 8 weeks|Patients with 1b HCV genotype will be received treatment with Elbasvir (50mg) during 8 weeks.
15998967|NCT02897596|Drug|Grazoprevir 100 mg/d 12 weeks|Patients with 1a or 4 HCV genotype will be received treatment with Grazoprevir (100 mg) during 12 weeks.
15998968|NCT02897596|Drug|Elbasvir 50 mg/d 12 weeks|Patients with 1a or 4 HCV genotype will be received treatment with Elbasvir (50mg) during 12 weeks.
15998969|NCT02897583|Procedure|YAG vitreolysis|
15998970|NCT02897570|Dietary Supplement|Glucose|50g of glucose dissolved in 250 to 300ml of water was drunk. Prior and upon completion of each glucose tolerance test, an EEG was performed.
15998971|NCT02897570|Dietary Supplement|Milk & Cereals|A breakfast (B1) including a glass of milk (125ml) and 30 g-corn flakes was consumed. Prior and upon completion of each tolerance test, an EEG was performed
15998972|NCT02897570|Dietary Supplement|Milk, apple & snack|A breakfast (B2) including a glass of milk (220ml), an apple (200g), a cream chocolate filled sponge cake (30g) was consumed. Prior and upon completion of each meal tolerance test, an EEG was performed.
15998973|NCT02897570|Dietary Supplement|Milk, apple & bread w/ cream|A breakfast (B3) including a glass of milk (125ml), an apple (150g), bread (50g, hazelnut chocolate cream (15g) was consumed. Prior and upon completion of each meal tolerance test, an EEG was performed.
15998974|NCT02897570|Device|EEG_pre|Electroencephalography (EEG) was performed prior each tolerance test to assess frontal P300-evoked potentials
15998975|NCT02897570|Device|EEG_post|Electroencephalography (EEG) was performed upon completion of each tolerance test to assess frontal P300-evoked potentials
15998976|NCT02897557|Device|Insulet Artificial Pancreas (AP) System|
15998977|NCT02897544|Behavioral|Individualized Manualized Health Education Intervention|
15998978|NCT02897531|Procedure|ES anastomosis|The side wall of the transverse colon will be anastomosed to the end of the distal ileum with one circular stapler, and the blind end of the transverse colon will be closed with one linear stapler.
15998979|NCT02897531|Procedure|SS anastomosis|The side wall of the transverse colon will be anastomosed to the side wall of the distal ileum with two linear staplers.
15998980|NCT02897518|Device|Imago V-Balde|the endotracheal intubation will be performed with videolaryngoscopes (imago V-Blade) according to the user manual
15998981|NCT02897518|Device|Glidescope|the endotracheal intubation will be performed with videolaryngoscopes (Glidescope) according to the user manual
15998982|NCT02897505|Behavioral|Music Workshop|At each music workshop, the study staff will collect participants' pre- and post-session Physiological and Emotional Thermometer Surveys. The pre-session survey will be conducted prior to the start of the music workshop, and the post-session survey will be conducted within 15 minutes after the conclusion of the workshop.
15998983|NCT02897492|Other|Blood testing in a newly described method|"To exploit detection strategy termed Magnetic Modulation Biosensing, or MMB) to develop a novel, low-cost platform that can detect biomarkers, such as proteins and specific DNA sequences, rapidly and directly from real samples at very low concentrations."
15998984|NCT02897479|Drug|Savolitinib|Enrolled patients will be treated with Savolitinib 600mg or 400mg once per day(QD), till disease progression, death or unacceptable toxicity, whichever comes first. A cycle of study treatment will be defined as 21 days of continuous dosing.
15999036|NCT02897063|Drug|Droxidopa|Single oral dose 300 mg
15999037|NCT02897063|Drug|Midodrine|Single oral dose 10 mg
15999038|NCT02897063|Drug|Placebo|sugar pill
15999039|NCT02897050|Drug|Docetaxel|Docetaxel 75mg/m2, iv, d1 or 100mg/m2, iv, d1
15999040|NCT02897050|Drug|Capecitabine|Capecitabine 1200mg/m2/d, po, d1-d21
15998985|NCT02897466|Other|Direct Antimicrobial Susceptibility Testing|An antibiotic susceptibility testing will be performed directly on respiratory samples with Gram negative bacilli on direct smear examination of intensive care patients suspected of ventilator-associated pneumonia. The result of this test associated with GNB identification using mass spectrometry will be given to the physician in charge of the patient at Day 1, one day earlier than the conventional AST. This rapid method will allow a re-evaluation (adequation and/or de-escalation) of the antibiotic probabilist treatment one day earlier than the conventional method.
15998986|NCT02897453|Device|The Spinal Tethering System|An implant comprised of: vertebral body screws, vertebral body staples (washers), and a PET (polyethylene-terephthalate) cord.
15998987|NCT02897440|Procedure|Full Repairng of soft tissue surrounding the hip|Full repairing soft tissue surrounding the hip damaged during the procedure of hip dislocation and prosthesis implanting.
15998988|NCT02897440|Procedure|Partial Repairng of soft tissue surrounding the hip|Partial repairing soft tissue surrounding the hip damaged during the procedure of hip dislocation and prosthesis implanting.
15998989|NCT02897427|Other|Biomarker Analysis|Complete HPV testing
15998990|NCT02897427|Procedure|Biospecimen Collection|Undergo collection of blood and oral gargle samples
15998991|NCT02897427|Procedure|Ultrasonography|Undergo transcervical ultrasonography
15998992|NCT02897414|Other|Surveillance of state medical examiner databases|
15998993|NCT02897401|Biological|pregnancy test|Collection of 5 mL of urinary sample.The pregnancy test is done in each investigator center.
15998994|NCT02897401|Biological|urinary cotinine assesment|Collection of 10 mL of urinary sample for cotinine analysis. The analysis is maid during the study and is centralised at the hospital Paul Brousse.
15998995|NCT02897401|Biological|Urinary NNN assesement|Collection of 20 mL of urinary sample for NNN analysis. The analysis is maid at the end of the study and is centralised in a laboratory located at Strasbourg.
15998996|NCT02897401|Behavioral|Questionnaire (Fagerstrom test)|This questionnaire will permit to assess the smoking habits of the participants.
15998997|NCT02897401|Procedure|Measurement of carbon monoxide levels expired|This test will permit to determinate if the participant are axposed to passive smoking or not.
15998998|NCT02897388|Other|breast milk consume promotion|(1)Team building: organize a multidisciplinary breast milk consume improvement team；(2) Staff education: one nurse to train in Canada for 1 month as lactation coordinator, lactation consultant from Canada to teach NICU staff for 1 month; (3) Send breastmilk teaching materials for parents to teach mothers about breast milk feeding;(4) allocate an area in the NICU as a breast pumping room with breastfeeding pumps and chairs to support mothers pumping milk and feeding their babies; (5)purchase 10 breast pumps from Medela and establish a loaner program for mothers; (6)provide lactation counseling & promote consistent communication about the benefits of mothers' milk to encourage mothers to provide milk for their infants;(7)Coaching by lactation coordinator and nursing staff
15998999|NCT02897375|Drug|Carboplatin|Given IV
15999000|NCT02897375|Drug|Cisplatin|Given IV
15999001|NCT02897375|Drug|Palbociclib|Given PO
15999002|NCT02897349|Drug|placebo|
15999003|NCT02897349|Drug|linagliptin|
15999004|NCT02897349|Drug|background therapy|insulin with or without metformin
15999005|NCT02897336|Procedure|ultrasound-guided|ultrasound-guided caudal epidural corticosteroid injection
15999006|NCT02897336|Procedure|interlaminar|interlaminar epidural corticosteroid injection
15999007|NCT02897323|Other|description|
15999008|NCT02897284|Behavioral|Mindfulness 8 weeks|8 sessions of mindfulness
15999009|NCT02897284|Behavioral|Mindfulness 2 weeks|2 sessions of mindfulness
15999010|NCT02897245|Other|No intervention|
15999011|NCT02897232|Other|Survey|Clinical Faculty and community will be given a survey to define issues preventing HPV Vaccination
15999012|NCT02897219|Drug|ipragliflozin|Oral administration once daily
15999013|NCT02897219|Drug|Placebo|Oral administration once daily
15999014|NCT02897219|Other|Insulin Therapy|Continuous subcutaneous insulin infusion or multiple daily injections as standard of care
15999015|NCT02897206|Drug|Imipenem|A wide-spectre antibiotic from the carbapenem group
15999016|NCT02897206|Drug|Placebo|An imipenem-matching placebo
15999017|NCT02897193|Device|ICE dental implant 4.2 mm|ICE dental implant 4.2 mm diameter
15999018|NCT02897193|Device|NICE dental implant 3.2 mm|NICE dental implant 4.2 mm diameter
15999019|NCT02897193|Device|Alpha Bio's Graft Bovine bone|Alpha Bio's Graft Bovine Bone
15999020|NCT02897193|Device|Alpha Bio's Graft resorbable membrane|Alpha Bio's Graft resorbable collagen membrane
15999021|NCT02897180|Biological|Nyaditum resae(R)|Capsules containing Nyaditum resae(R)
15999022|NCT02897180|Biological|Placebo|Capsules containin Placebo
15999023|NCT02897167|Genetic|Retrospective study of frozen samples|Frozen samples of serum and peripheral blood mononuclear cell (PBMC) stored in the Biobank Valdecilla will be selected.
15999024|NCT02897167|Genetic|Prospective study of fresh samples|Samples of serum and cells will be drawn.
15999025|NCT02897154|Diagnostic Test|In-vitro|
15999026|NCT02897141|Device|Health Management App with symptom strategies|The mVIP group will receive a Health Management App with symptom strategies. A mobile app which includes symptom strategies from the UCSF symptom management manual.
15999027|NCT02897141|Device|Control App|The attention control group will receive an app which asked them about their symptoms but did not provide symptoms strategies
15999028|NCT02897128|Other|Observational Only - Transcutaneous Oxygen Measurement|The transcutaneous oxygen at your surgical site will be measured at three time points prior to your surgery.
15999029|NCT02897115|Biological|Adalimumab|Administered every other week by subcutaneous injection for up to 48 weeks, depending on participants' disease activity.
15999030|NCT02897115|Other|Non-steroidal Anti-inflammatory Drugs (NSAIDs)|ASAS recommended NSAID doses to treat axial spondyloarthritis.
15999031|NCT02897102|Behavioral|Training|Training program based on abacus and other activities
15999032|NCT02897102|Other|Different group activities|ballroom dancing (5 participants), belly dancing (4 participants), chorus (16 participants), Spanish classes (8 participants) and chorus and Spanish classes (6 participants).
15999033|NCT02897089|Device|Adhesive agent|Agents used to bond the restorative materials to teeth structure.
16067972|NCT02397720|Biological|Ipilimumab|
15999044|NCT02897050|Drug|Cyclophosphamide (injection)|Cyclophosphamide 500mg/m2, iv, d1
15999045|NCT02897037|Drug|Bivalirudin|Patients would be given anticoagulant therapy with bivalirudin in acute myocardial infarction during emergency PCI operation.
15999046|NCT02897037|Drug|heparin|heparin monotherapy
15999047|NCT02897024|Other|Physical Therapy|One-on-one physical therapy sessions (one therapist and one patient). Principles of motor learning used include repetition, task-specificity, active practice, generalization of skills, errors, structured practice, and developmentally appropriate feedback with sufficient time to practice.
15999048|NCT02897011|Drug|Methotrexate|
15999049|NCT02896998|Procedure|Removal on demand of the syndesmotic screw|The syndesmotic screw will only be removed in case of a symptomatic implant (e.g. implant causing pain or restricted range of motion)
15999050|NCT02896998|Procedure|Routine removal of fhe syndesmotic screw|The syndesmotic screw will routinely be removed 8 - 12 weeks following placement of the screw
15999051|NCT02896972|Procedure|Vitrectomy|Vitrectomy with inverted ILM technique or ILM peeling
15999052|NCT02896959|Procedure|Arthroscopic rotator cuff repair|
15999053|NCT02896946|Radiation|Diffusion-weighted nuclear magnetic resonance imaging|All MRI examinations will be carried out using a Siemens Magnetom Avanto syngo MR B15 1.5 Tesla (Erlangen, Germany) or a Philips Intera 1.5 Tesla (Eindhoven, The Netherlands) and will include the following sequences: (i) T2 fat sat, with a FOV of 350 x 262, and a matrix of 384 x 207; slices, 30 per sequence, 6 mm thick; (ii) T1 in-phase and out-of-phase with a FOV of 380 x 262, and a matrix of 256 x 158; slices, 30 per sequence, 6 mm thick; (iii) T1 water excitation (= T1 ProSat), with a FOV of 300 x 300, and a matrix of 320 x 220; obtaining 20 slices of 4 mm; (iv) VIBE and THRIVE (dynamic T1 axial 3D EG after injection, during the arterial, portal venous, and late phases, in an axial plane, and optionally in a coronal plane during the portal venous phase), with a FOV of 400 x 312, a matrix of 384 x 192, and with fat suppression and breath-hold; slices 3 mm thick, with liver and pancreatic coverage. Contrast agent: gadobenate dimeglumine (MultiHance, Bracco Imaging, France).
15999054|NCT02896907|Drug|Oxaliplatin|Given IV
15999055|NCT02896907|Drug|Irinotecan Hydrochloride|Given IV
15999056|NCT02896907|Drug|Leucovorin Calcium|Given IV
15999057|NCT02896907|Drug|Fluorouracil|Given IV
15999058|NCT02896907|Dietary Supplement|Ascorbic Acid|Given IV
15999059|NCT02896894|Other|Big White Wall (BWW)|"The BWW is an internet-based intervention that incorporates several elements of mental health care that have been shown to be effective, in a virtual environment that provides anonymity (see www.bigwhitewall.com). The on-line portal gives users access to self-assessment tools to track symptoms for a wide range of conditions over time, educational materials, a social network that allows communication between people who may have similar problems, and access to on-line courses. The service is monitored at all times by Wall Guides to ensure that users are responded to and that the content posted is appropriate and safe."
15999060|NCT02896868|Drug|LY3041658|Administered IV.
15999061|NCT02896868|Drug|Placebo|Administered IV.
15999062|NCT02896855|Drug|Docetaxel|Docetaxel (75-mg/m^2) administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.
15999063|NCT02896855|Drug|Pertuzumab|Pertuzumab (840-mg loading dose for Cycle 1, followed by 420 mg for subsequent cycles) administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.
15999064|NCT02896855|Drug|Placebo|Placebo matched to pertuzumab administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.
15999065|NCT02896855|Drug|Trastuzumab|Trastuzumab (8-mg/kg loading dose for Cycle 1, followed by 6 mg/kg for subsequent cycles) administered by IV infusion every 3 weeks until disease progression or unacceptable toxicity.
15999066|NCT02896842|Drug|Posology dose modification|
15999067|NCT02896842|Other|active comparator|
15999068|NCT02896829|Behavioral|Interruption of the treatment by Imatinib|
15999069|NCT02896816|Other|Surface EMG, MRI and PET Scan|It will consist of two assessment sessions; one where muscle activity of the arms as well as movement characteristics will be assessed during a reaching task; and another where muscle activity of the legs and movement characteristics will be assessed while walking on a treadmill. Clinical evaluations will also be performed. In addition, individuals with Parkinson's disease will undergo brain scans at Massachusetts General Hospital to examine whether there are any relationships between muscle activity and brain function.
15999070|NCT02896816|Other|Surface EMG|It will consist of two assessment sessions; one where muscle activity of the arms as well as movement characteristics will be assessed during a reaching task; and another where muscle activity of the legs and movement characteristics will be assessed while walking on a treadmill. Clinical evaluations will also be performed.
15999071|NCT02896803|Drug|mFLOX|5-fluorouracil 500 mg/m2 and folinic acid 20 mg/m2 infused both bolus weekly for 6 weeks (d1, 8,15, 22, 29 and 36) and oxaliplatin 85 mg / m2 infused over 2 hours at weeks 1,3 and 5 (d1,15 and 29). The scheme will be repeated every 8 weeks.
15999072|NCT02896790|Other|Interviews with 2 oncologists and 10 patients|
15999073|NCT02896790|Other|Interviews with 15 patients|
15999074|NCT02896777|Other|Transfer embryo from pH 7.20±0.02 on either Day 3 or day 5/6|Post IVF/ICSI and according to the result of the randomization process, women will receive embryo from their oocytes that will be cultured in pH of 7.20±0.02.
15999075|NCT02896777|Other|Transfer embryo from pH 7.3±0.02 either Day 3 or day 5/6|Post IVF/ICSI and according to the result of the randomization process, women will receive embryo from their oocytes that will be cultured in pH of 7.3±0.02.
15999076|NCT02896777|Other|Transfer embryo from pH of 7.4±0.02 on either Day 3 or day 5/6|Post IVF/ICSI and according to the result of the randomization process, women will receive embryo from their oocytes that will be cultured in pH of 7.4±0.02 from day 0 to 5/6
15999077|NCT02896764|Device|Cone-beam CT|
15999078|NCT02896751|Device|3D printed NIV mask|use of 3D printed mask
15999079|NCT02896725|Device|Keratin dressings|Wool-derived keratin matrix dressings applied with each change of the compression bandage until healing or the trial ends
15999080|NCT02896725|Device|Usual care dressings|Dressings chosen from study centres' formulary of non-medicated moist wound dressings (non-adherent dressings, hydrogel, alginate, hydrofibre or polyurethane foam dressings) applied with each change of the compression bandage until healing or the trial ends
15999398|NCT02894112|Dietary Supplement|non-fat milk|1 serving of non-fat fluid milk
15999081|NCT02896712|Behavioral|Acceptance and Commitment Therapy (ACT)|ACT will assist cocaine patients to notice internal cravings and triggers, abandon attempts to manage these triggers via active avoidance, suppression or other control-based strategies, and to make commitments to engage in behaviors consistent with chosen values or goals. ACT encourages clients to experience thoughts and feelings from an observer perspective, and helps clients not to believe distressing thoughts and feelings as if those thoughts and feelings are literally true and in need of action. ACT treatment will be based on the ACT therapy manual developed and tested previously.
15999082|NCT02896712|Behavioral|Drug Counseling (DC)|The investigators will use the manual-guided individual DC modeled after the NIDA Collaborative Cocaine Treatment Study and used as the active control therapy in previous studies. DC approximates clinical practice as it is considered the most common type of evidence-based treatment in the community for patients actively using cocaine.
15999083|NCT02896712|Behavioral|Contingency Management (CM)|The investigators will use the same high-magnitude CM schedule shown previously to be feasible and effective in facilitating initial cocaine abstinence. Subjects will earn vouchers for cocaine-negative urine samples collected at scheduled clinic visits each week. Under an escalating reinforcement schedule, voucher values will begin at $15 and increase by $10 for each consecutive negative urine. Bonus vouchers of $10 will be given for three consecutive negative urines. Provision of a cocaine-positive urine or failure to provide a scheduled sample will result in no vouchers earned and will reset the schedule to the initial value of $15.
15999084|NCT02896712|Drug|Placebo|The placebo capsule will be filled with corn starch and riboflavin.
15999085|NCT02896712|Drug|Modafinil|Modafinil capsules will start at 200 mg (day 1) and increase to the fixed dose of 300 mg (day 2) and will also contain riboflavin.
15999086|NCT02896699|Behavioral|PrEP Intervention Group|
15999087|NCT02896699|Other|Control Group|
15999088|NCT02896686|Radiation|Control CT|"At the end of the follow up (12 Months) a CT scan will be done. Radiologically the incisional hernia is defined as a solution of continuity of the abdominal wall seen on the abdominal CT scan with the patient at rest.
~The radiologist is blinded to the patient's history and the technique used for fascial closure."
15999089|NCT02896686|Other|Clinical Follow Up|The presence of incisional hernia was evaluated by physical examination at scheduled clinical visits (3 and 6 months after surgery) Clinically, an incisional hernia is defined as the presence of a reducible bulge or protrusion at the laparotomy incision scar, palpable during the Valsalva maneuver.
15999090|NCT02896686|Procedure|Reinforcement with Light Polypropylene Mesh|Reinforcement with Light Polypropylene Mesh
15999091|NCT02896673|Procedure|ventilatory conditions and measures with scanner and EIT|"Different ventilatory conditions are studied and measures are acquired with scanner and EIT
~Time A: measure under basal conditions (TVbasal=6ml/kg of predicted weight), basal PEP, basal inspiratory time / total time = 30%)
~Time B: different PEP are applied for 4 minutes: 5, 10, 15, 20 cm of H2O conserving the basal TV
~Time C: different TV are applied for 4 minutes: 4, 7, 10 ml/kg of predicted weight conserving the basal PEP and the basal inspiratory time
~Time D: recruitment in continuous positive airway pressure at 45 cm of H2O is performed for 30 seconds
~Time E: return to adjustment period A"
15999092|NCT02896660|Device|ActiGraph Link|Subjects will be asked to wear the actigraph continuously for a 90-day period, and visit a clinician on day 30, 60, and 90 of the study for data collection.
15999093|NCT02896634|Biological|clinical biology analyzes spectrometry mass|clinical biology analyzes spectrometry mass
15999094|NCT02896621|Drug|Chlorthalidone plus amiloride|A capsule with chlorthalidone plus amiloride was taken once daily in the morning for eight weeks.
15999095|NCT02896621|Drug|Amlodipine|A capsule of amlodipine was taken once daily in the morning for eight weeks.
15999096|NCT02896608|Device|measure of neuronal excitability|
15999097|NCT02896595|Device|General Anesthesia with endotracheal tube|Patient randomized to this arm will have general anesthesia with endotracheal tube placed and will be kept at an appropriate depth of anesthesia for patient comfort and procedure needs.
15999098|NCT02896595|Device|General Anesthesia with laryngeal mask airway|Patients randomized to this arm will have general anesthesia with laryngeal mask airway placed and will be kept at an appropriate depth of anesthesia for patient comfort and procedure needs.
15999099|NCT02896582|Drug|Obinutuzumab|1000 mg D1, D8, D15 in GA-DHAP 1000 mg D-8 in GA-BEAM 1000 mg every 2 months for 3 years then every month if MRD+
15999100|NCT02896582|Drug|Dexamethasone|40 mg D1 to D4 in GA-DHAP
15999101|NCT02896582|Drug|Aracytine|2g/m² D1 & D2 in GA-DHAP 400 mg/m² D-6 to -3 in GA-BEAM
15999102|NCT02896582|Drug|Cisplatinum|100 mg/m² D1 in GA-DHAP
15999103|NCT02896582|Drug|Etoposide|400 mg/m² D-6 to D-3 in GA-BEAM
15999104|NCT02896582|Drug|Melphalan|140 mg/m² D-2 in GA-BEAM
15999105|NCT02896582|Drug|Carmustine|300 mg/m² D-7 in GA-BEAM
15999106|NCT02896569|Other|Topical combination therapy|
15999107|NCT02896556|Device|Resin infiltrate|A resin that used for micro-invasive treatment of enamel-restricted, non-cavitated caries or hypo/demineralized smooth enamel surfaces.
15999108|NCT02896543|Other|measurement|Blood is obtained into ethylene diamine tetraacetic acid（EDTA） tubes from all subjects via antecubital vein puncture to measure the number of dendritic cells(DCs) and the concentration of sP-selectin. The number of dendritic cells(DCs) and the concentration of sP-selectin are measured in all patients with STEMI at 0 and 5-7 days after admission. The number of dendritic cells(DCs) and the only once in control group after admission.
15999109|NCT02896530|Other|No intervention. Description study|
15999110|NCT02896504|Drug|Exposure: Adjuvant chemotherapy treatment|
15999111|NCT02896504|Drug|Exposure: Adjuvant hormonal therapy treatment|
15999112|NCT02896491|Radiation|Exposure with non-ionizing electromagnetic fields|In a cross-over design subjects will be exposed to sham (placebo), GSM 900 MHz (2W/kg) and TETRA (6W/kg)
15999113|NCT02896478|Other|No intervention. Only observational study|
15999114|NCT02896465|Other|Oral rehydration solution|
15999115|NCT02896465|Other|Zinc|
15999116|NCT02896465|Other|Human milk oligosaccharides|
15999117|NCT02896465|Other|Breastfeeding|
15999150|NCT02896166|Other|microwave ablation|eligible patients will be treated with microwave ablation in the primary tumor sites
15999151|NCT02896153|Other|Questionnaire|
15999152|NCT02896140|Other|Type 2 diabetes in WhyWAIT Program|The sum of servings per day of milk, cheese, yogurt, and other dairy foods.
15999118|NCT02896439|Device|Neurophysiological MONITORING|"The neurophysiology team perform:
~Implementation of the stimulation electrodes and collection (needle electrodes) SEP and EMG as described above.
~Acquisition of data by the machine and the software Protektor® (Natus) in the following format:
~A PES stimulation every 10 minutes consistently. Meanwhile, important surgical time and known to be at risk for neurological injury will be noted and their exact schedule specified:
~Establishment of a spacer or forceps in the greater or lesser sciatic notch
~Traction layout
~For the ways of Kocher-Langenbeck, a collection of potential nerve sciatic trunk upstream of the critical region:
~At the end of the incision
~On the establishment of a spacer or forceps in the greater or lesser sciatic notch
~When towing layout
~At the end of the intervention"
15999119|NCT02896426|Behavioral|Collaborative Problem Solving|CPS is an approach for understanding and reducing challenging behavior in youth. Under CPS, caregivers are taught to understand and identify the specific neurocognitive skill deficits that underlie their child's challenging behavior. Then the caregivers are taught to interact with the child in a way that solves chronic behavior problems while building the lagging neurocognitive skills to avoid future problems.
15999120|NCT02896426|Behavioral|Positive Solutions For Families|Positive Solutions for Families groups provide information for families on how to promote children's social and emotional skills, understand their problem behavior, and use positive approaches to help children learn appropriate behavior.
15999121|NCT02896413|Drug|Dexmedetomidine group|dexmedetomidine infusion (0.4 mcg/kg/h) from immediately after anesthetic induction to 24 h after surgery
15999122|NCT02896413|Drug|Control group|0.9% saline infusion
15999123|NCT02896400|Behavioral|Brief Negotiated Interview (BNI)|Brief motivational interview on smoking behavior
15999124|NCT02896400|Drug|Nicotine replacement therapy (NRT)|6 weeks of nicotine replacement, patches and gum. First dose of each started in ED. Patches are 14mg or 21 mg. Gum is 2mg per piece.
15999125|NCT02896400|Other|CT Smokers Quitline (QL)|Faxed referral to the CT Smokers Quitline for the subject. QL will then call subject to offer phone based counseling.
15999126|NCT02896400|Other|SmokefreeText (Text)|Enrollment in a version of NCI's SmokefreeTxt, tailored for the study.
15999127|NCT02896374|Behavioral|Theory of mind without visual cues|Theory of mind stimulation without visual reinforcement while performing EEG recordings
15999128|NCT02896374|Behavioral|Theory of mind without visual cues|Theory of mind stimulation with visual reinforcement while performing EEG recordings
15999129|NCT02896361|Device|Reprogramming of spinal cord stimulator (Proclaim or Prodigy SJM internal pulse generator) parameters according to study protocol|Stimulation parameters are reprogrammed from original values to study defined ones
15999130|NCT02896348|Device|SynPhNe platform|SynPhNe is a non-invasive device. It consists of a piece worn around the forearm, a head component and it communicates wirelessly with the computer to provide feedback while performing motor tasks with the hemiparetic hand. The head cap records brain activity and gives feedback to help relaxing while exercising. The arm and the head component communicate wirelessly with the computer via Bluetooth. The head component reads brain signals while the arm gear senses your muscle signals when performing the exercises. The computer software adopts the appropriate difficulty level, speed and duration of the exercise depending on brain and muscle status to minimize fatigue.
15999131|NCT02896348|Other|Conventional therapy|Exercise program established with a therapist (8 sessions under therapist direct supervision and 10 sessions at home). Low functioning subjects will be given more proximal joint-muscle exercises and activities while higher functioning subjects will have a greater component of distal tasks and activities. The therapist will review the exercises therapy plan with the subject and re-adjust it.
15999133|NCT02896322|Radiation|Partial breast irradiation with cyberknife|
15999134|NCT02896309|Dietary Supplement|Sodium bicarbonate|
15999135|NCT02896309|Dietary Supplement|Sodium chloride|
15999136|NCT02896296|Drug|RBP-6000|Monthly injections subcutaneously on alternate sides of participant's abdomen. Dose could be adjusted from 100 mg to 300 mg (or the reverse) based on the medical judgment of the investigator.
15999137|NCT02896283|Radiation|Low-level laser therapy|Low-level laser therapy with the following parameters: Wavelength:660 nanometer, power: 200 mW, continuous mode, tme of irradiation: 32 seconds
15999138|NCT02896283|Radiation|Turned-off laser|Laser device is turned-off. All parameters are like experimental group, however the laser in turned-off.
15999139|NCT02896270|Drug|Valproic Acid|The concomitant immunosuppressive regimen is to be reduced at the discretion of the investigators. It is suggested to lower immunosuppressive therapy only in valproic acid target trough levels have been attained.
15999140|NCT02896257|Other|Guideline treatment recommendations|Patient-tailored E-consult, orders and rationale to discontinue inhaled corticosteroids and discontinue or receive other COPD related care.
15999141|NCT02896244|Other|no intervention|
15999142|NCT02896231|Drug|PLB1001|PLB1001 is a capsule in the form of 25 mg and 100mg, twice daily.
15999143|NCT02896218|Other|Pharmacists consultation|Pharmacists consultation of vancomycin individualized dosing strategy
15999144|NCT02896205|Drug|Mycophenolate mofetil|Subjects will be given oral Mycophenolate Mofetil starting at 500mg twice a day and increased gradually to a target dose of 2gram per day for 6 months
15999145|NCT02896205|Drug|Placebo|Subjects will be given matching placebo for 6 months
15999146|NCT02896192|Drug|Setmelanotide|RM-493 once daily subcutaneous injection
15999147|NCT02896192|Drug|Placebo|During the double blind placebo withdrawal period, patients will receive RM-493 or placebo at variable times over an 8 week period in order for patients to serve as their own control.
15999148|NCT02896179|Device|Robot-assisted gait training group+VR|The first group will be subjected to Robot-assisted gait training (RAGT) for 6 weeks (2 sessions/ week) with a total of 12 sessions by mean of GEO System plus Virtual Reality scenario. During each session, the patients will practice 15 to 20 min of simulated floor walking with simulating of a real walking trail. Each session will last up to 50 minutes, the first 30 minutes will be dedicated to gait training and the last 20 minutes to stretch the lower limb's muscles.
15999149|NCT02896179|Device|GEO|The second group will be subjected to Robot-assisted gait training (RAGT) for 6 weeks (2 sessions/ week) with a total of 12 sessions by mean of GE-O System. During each session, the patients will practice 15 to 20 min of simulated floor walking. Each session will last up to 50 minutes, the first 30 minutes will be dedicated to gait training and the last 20 minutes to stretch the lower limb's muscles
15999153|NCT02896127|Drug|Secukinumab|"Induction: 4x 150 mg Secukinumab s.c. weekly
~Maintenance: 150 mg Secukinumab s.c. monthly
~All Subjects received blinded treatment weekly starting at baseline, Weeks 1, 2, 3 and 4, followed by dosing every four weeks starting at Week 4 until Week 16. At Week 16, Group 1 patients continued using secukinumab 150 mg and Group 2 patients started receiving secukinumab 150 mg dosing every four weeks. Treatment was provided open-label from Week 16 onward, as all patients took 150 mg s.c. every 4 weeks; however, subjects, investigators, and site staff remained blinded to initial randomized group assignment."
15999154|NCT02896127|Drug|Placebo|Induction: 4x placebo s.c. weekly Maintenance: placebo s.c. monthly
15999155|NCT02896101|Drug|Pimecrolimus Cream, 1%|
15999156|NCT02896101|Drug|Elidel® (pimecrolimus) Cream|
15999157|NCT02896101|Drug|Placebo of Pimecrolimus Cream, 1%|
15999158|NCT02896088|Other|decayed tooth surfaces|The main variable is the number of new decayed tooth surfaces between the end and the beginning of the research. The caries experience will also be evaluated and expressed by the index 'dmfs' (accumulation of decayed tooth surfaces over those missing or filled due to caries). The secondary variable will be the expression of the retention of AS. The comparison of caries incidence between the two groups of teeth (with and without AS) will take into account the membership of the teeth to the same subject by means of the statistical test Chi-McNemar two. Regression models logistics and Poisson regression will be used to test the effect of independent variables on the appearance of new cavities. The Stata statistical software will be used.
15999159|NCT02896075|Other|30 Minute Comedy Video|The intervention is a 30 minute video of a comedy
15999160|NCT02896075|Other|30 Minute Documentary Video|The intervention is a 30 minute video of an uninteresting documentary
15999161|NCT02896062|Behavioral|sleep-coaching|Sleep-coaching with elements of cognitive behavioral therapy for insomnia and general information about sleep
15999162|NCT02896049|Device|Hyperthermia|treatment with the Celsius42 Hyperthermia System additional to radiotherapy and/or chemotherapy
15999163|NCT02896036|Procedure|Veress needle entry with concomitant CO2|The Veress will be connected to the CO2 tubing, and a skin incision will be made with the scalpel, followed by starting the CO2 gas insufflation and insertion of the Veress needle.
15999164|NCT02896036|Procedure|Veress needle entry with subsequent CO2|A skin incision will be made with the scalpel. The Veress needle will be inserted until intraperitoneal location obtained. This will be followed by starting CO2 gas insufflation until the standard 15 mmHg.
15999165|NCT02896023|Drug|human menopausal gonadotropin|Induction of ovulation followed by ICSI
15999166|NCT02896010|Other|Sweetch App + DBWS|Usual care for prediabetes management, Sweetch app, weight monitoring via digital body weight scale (DBWS).
15999167|NCT02896010|Other|Sweetch App Alone|Usual care for prediabetes management, Sweetch app alone.
15999168|NCT02895997|Other|Travel Telehealth Delivery|Clinical Operations Room (COR) staff will travel to Sydney Australia to deliver telehealth to patients in Georgia United States. Upon arrival, participants will have eight nights and seven days free of clinical responsibilities. Thereafter, each participant will work four consecutive days of 12 hour shifts followed by four consecutive days with no clinical assignment. The following week, participants will work three consecutive days of 12 hour shifts followed by four consecutive days with no clinical assignment. Upon return to the USA, participants will have a week free of clinical responsibilities.
15999169|NCT02895984|Behavioral|Single-session alcohol intervention (BMI)|The intervention recipients will receive a 1-hour individual BMI. The BMI will follow the central principles of Motivational Interviewing (MI) and will include all the components determined to be efficacious in existing multi-component BMIs (e.g., personalized feedback on indicators of alcohol-related risk, including signs of alcohol dependence and family history of alcohol risk; normative comparisons of the participant's alcohol consumption with same-sex peers in his/her dorm and throughout campus, and protective behavioral strategies). Additional components will include reviewing the pros and cons of the participant's current pattern of alcohol use, providing estimates of the participant's recent Blood Alcohol Concentration (BAC), and providing information about risks of specific negative outcomes at different levels of drinking. Participants will identify goals for behavior change, and with the counselor will develop a plan to achieve the goals and to address barriers to success.
15999170|NCT02895958|Drug|Zepatier|Zepatier (elbasvir and grazoprevir +/- Ribavirin) will be administered in a community setting to HCV infected G1/4 treatment naïve patients on stable opiate substitution therapy with Cirrhotic and Non-cirrhotic liver disease
15999172|NCT02895932|Radiation|PET imaging|Serotonin, Dopamine and Amyloid PET imaging
15999173|NCT02895919|Other|Culture|culture of ascitic fluid in standard culture media of blood culture bottles at bedside and fluid collected for culture in laboratory (study arm).
15999174|NCT02895906|Drug|NFC-1|Doses of NFC-1 will be administered as 50, 100, 200, or 400 mg twice daily as size 2, hard gelatin capsules for oral administration.
15999175|NCT02895893|Behavioral|PrEP Smart|Men who have sex with men and already prescribed and taking oral PrEP will use an application on their smart phone for 4 weeks.
15999176|NCT02895880|Behavioral|usual care|In order to characterize the content of and variation in usual care, the first 25 patients enrolled in the study will complete a post-visit questionnaire that asks what their doctor told them (if anything) about their risk of cardiovascular disease, risk reduction and statins specifically, and how this information was presented
15999177|NCT02895880|Behavioral|statin communication tool|The Statin Choice decision aid uses icon arrays to communicate the expected benefits of statins. This modified risk communication tool will maintain the components of the validated original. The adapted paper-based risk communication tool will describe modified risk profiles applicable to the survivors at increased risk for cardiac disease due to chest irradiation.
15999178|NCT02895867|Other|Full fat dairy|Participants will receive nutritional counseling aiming to maintain body weight from a registered dietician and will be instructed to include at least ≥3 servings of full fat dairy products into their diet
15999179|NCT02895867|Other|Low fat dairy|Participants will receive nutritional counseling aiming to maintain body weight from a registered dietician and will be instructed to include at least ≥3 servings of low fat dairy products into their diet
15999749|NCT02891382|Behavioral|Individual Reward|The cash reward is given to the patient with diabetes.
15999180|NCT02895867|Other|Control|Participants will receive nutritional counseling aiming to maintain body weight from a registered dietician and will not be asked to include a specified amount or type of dairy products
15999181|NCT02895854|Radiation|Hypofractionated RT 5 x 7,25 Gy|
15999182|NCT02895854|Radiation|LDR-brachytherapy with I125 seeds|
15999183|NCT02895841|Other|SMART app wearable|"Patients will be given a wearable such as a Microsoft Band accelerometer to track movement, heart rate, galvanic skin response and sleep, which will be collected in combination with the data from the SMART visual dashboard. Data will be sent to the SMART dashboard as well as stored on the iPad/iPod touch via software from the manufacturer. Participants having a wearable device will receive the education intervention (such as haptic prompted texts that state 'try and walk today', 'have you had enough water today', 'make sure to take deep breaths')."
15999184|NCT02895828|Other|Core Stabilization Exercise|the participants asked to performed CSE program, 20 min/session, 2 session/week, 10 weeks
15999185|NCT02895828|Other|General Strengthening Exercise|the participants asked to performed GSE program, 20 min/session, 2 session/week, 10 weeks
15999186|NCT02895815|Combination Product|CNTO 2476 (6.0 * 10^4 cells)|Participants will receive a single subretinal administration of CNTO 2476 (6.0 * 10^4 cells) in 50 mcL given by subretinal delivery system (subretinal access kit [SRAK-02 kit] and third arm accessory).
15999187|NCT02895815|Combination Product|CNTO 2476 (3.0 * 10^5 cells)|Participants will receive a single subretinal administration of CNTO 2476 (3.0 * 10^5 cells) in 50 mcL given by subretinal delivery system (SRAK-02 kit and third arm accessory).
15999188|NCT02895802|Behavioral|Verbal instructions with picture diagram|verbal instructions and picture diagram
15999189|NCT02895802|Behavioral|Verbal instructions with video of ADSC|Verbal instructions and watching video depicting ADSC
15999190|NCT02895802|Behavioral|verbal instructions w. video of w/o DS|verbal instructions and watching video depicting person without DS washing her hands
15999191|NCT02895802|Behavioral|verbal instructions w. video w/DS|verbal instructions and watching video depicting person with DS washing his hands
15999192|NCT02895763|Other|Form administrations|
15999193|NCT02895750|Drug|Metformin|Metformin extended release tablets (Glucophage 500 mg; 750 mg; 1,000 mg) administrated during 6 to 12 weeks (CKD1 and 3B, respectively)
15999194|NCT02895737|Device|TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra|
15999195|NCT02895737|Device|TAVI: Edwards SAPIEN 3, Edwards Lifesciences, Edwards Sapien Ultra; Sentinel™ Cerebral Protection Systems|
15999196|NCT02895737|Device|TAVI: CoreValve® Evolut R™, CoreValve Medtronic|
15999197|NCT02895737|Device|TAVI: CoreValve® Evolut R™, CoreValve Medtronic; Sentinel™ Cerebral Protection Systems|
15999198|NCT02895724|Drug|Medical Oxygen|Hyperbaric oxygen therapy
15999199|NCT02895698|Device|Dry cupping|Dry cupping. First, the therapist identified the trigger point on calf muscle.After identification of the trigger point, the participant was in prone with the ankle outside the edge of the bed. Ultrasound gel was then placed over the trigger point as a lubricant to increase the suctioning of the plastic vacuum cup, after which the cup was placed. Air was withdrawn from the cup to create a suction force. The cup was maintained for 10 minutes, and the participant was asked to do active ankle dorsiflexion exercise after 5 minutes of placing the cup. The therapist held the cup in place while the participant performed exercise.
15999200|NCT02895698|Other|Stretching exercises|"The participant was in prone with the ankle outside the edge of the bed. The participant was asked to do active ankle dorsiflexion exercise after 5 minutes of lying on bed.
~Standing self-stretching of the calf muscles.
~Plantar fascia-specific self-stretching.The participant was instructed to start gently at first and then to work more aggressively as long as the pain is tolerable.
~All stretches were done six times and the duration of each stretch is 30 seconds."
15999201|NCT02895685|Other|Dyad training|Participants will be paired in teams at the introduction. Participants will be instructed to train and supervise each other in pairs and will receive information on how to give constructive feedback. Participants will practice in pairs during on-site classes and encouraged to train in pairs during the self-regulated training at home. At the on-site classes, participants will be instructed to practice with their partner, during the expert-guided self-training and receive all feedback in pairs. Participants will train at the same table with space for two people. Outside the classroom, participants will decide themselves when and how often they will meet to practise. Participants are instructed to actively observe his or her partner while practising and are encouraged to discuss their performance and any difficulties they encounter. Testing will be done individually. With the training log, the investigators will measure whether the participants train in pairs at home as instructed.
15999202|NCT02895672|Drug|GLP-1 therapy|The investigators will assess the efficacy and safety of 12 months of GLP-1 therapy added to the therapeutic regimen of a group of T2DM patients who have received basal insulin therapy for a minimum of one year.
15999203|NCT02895659|Procedure|perioperative hemodynamic management with vasoactive medications (norepinephrine, adrenaline ect)|Perioperative hemodynamic management will be performed according to a specified treatment protocol.
15999204|NCT02895646|Other|Collection of blood sample|
15999205|NCT02895633|Other|Ecography|Standard Doppler ultrasound and perfusion imaging after injection of Sonovue
15999206|NCT02895633|Other|CT scan|With injection of Iomeron 400
15999207|NCT02895633|Other|MRI|With injection of gadolinium (Multihance)
15999208|NCT02895620|Biological|Xpert bladder Test|Xpert test positive or negative on urine samples of NMIBC patients treated by BCG
15999209|NCT02895607|Procedure|Ambulatory care among eligible patients|"The management of Anterior Cruciate Ligament (ACL) Reconstruction reconstruction in outpatient will be proposed in consultation with the surgeon.
~After an explanation of the course of treatment a fact sheet on the protocol will be provided to the patient and his doctor to the patient to decide its support in CA (ambulatory surgery) or HC (conventional hospitalization)."
15999210|NCT02895555|Procedure|i-FACTOR|Between 5-10 CC i-FACTOR putty mixed with local harvested autograft pr level spondylodesis compared to 30 grams of allograft pr level mixed with local harvested aulograft.
15999211|NCT02895555|Procedure|Allograft|Approx 50 g of allograft bone in the fused site
15999344|NCT02894593|Other|0.20% chlorhexidine mouthwash|All subjects were instructed to rinse twice a day, in the morning and in the evening, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.
15999212|NCT02895529|Drug|Itraconazole|Participants will receive 200 milligram (mg) of itraconazole intravenously (IV) twice daily on Day 1 and Day 2, followed by 200 mg once daily through Day 14. From Day 15 to Day 28, participants will receive 200 mg (20 milliliters [mL]) of itraconazole oral solution orally twice daily. Participants, who are not suitable for oral administration of itraconazole based on the investigator's judgment, will receive 200 mg of itaconazole IV once daily from Day 15 to Day 28.
15999213|NCT02895529|Drug|Caspofungin|Participants will receive 70 mg of caspofungin IV once daily on Day 1 followed by 50 mg IV infusion once daily thereafter through Day 28.
15999214|NCT02895516|Device|Vibrating capsule|Patients will receive vibrating capsule for 6 weeks of treatment (2 capsules per week)
15999215|NCT02895503|Behavioral|Yoga|Participate in yoga
15999216|NCT02895503|Behavioral|Support Group Therapy|Participate in emotional support group therapy
15999217|NCT02895503|Other|FACT-L|This is a 44-item self-report instrument which measures multidimensional HRQOL. There are 5 sections dealing with physical, family, emotional, and functional well-being and their relationship with the doctor. There are nine questions in a sixth subscale that are specific to lung cancer (LSC), including shortness of breath, cough, etc. The TOI is the sum of the scores on the LCS and the physical well-being and functional well-being subscales of the FACT-L scale. The FACT-L has been shown to be reliable and valid and sensitive. (Cella, Bonomi, Lloyd, DS, Kaplan, & Bonomi, 1995). The instrument has been used with patients with lung cancer in the Massey Cancer Center.
15999218|NCT02895503|Other|Pulmonary function test|The pulmonary function test includes forced vital capacity (FVC), forced expiratory volume in 1 second (FEV1) and peak expiratory flow rate (PEFR). Use of a digital spirometer provides an objective and reliable measure of the patient's vital capacity.
15999219|NCT02895490|Other|educational intervention|Receive a DVD containing educational information and communication skills
15999220|NCT02895490|Other|communication skills training|Receive a DVD containing educational information and communication skills
15999221|NCT02895490|Other|educational intervention|Receive information about the LINC group
15999222|NCT02895490|Other|questionnaire administration|Ancillary studies
15999223|NCT02895490|Other|quality-of-life assessment|Ancillary studies
15999224|NCT02895477|Device|hearing aid|
15999225|NCT02895464|Other|Exercise|The sessions will be led by a physiotherapist, in the older person's home. The sessions will consist of inspiratory muscle training with a resistance starting from 50% of their maximal capacity (30 breathes, 2 times/day). The training session will also consist of high-intensity individually adjusted functional strength and endurance training: chair-stand; stair climb/step up with weight belts, interval walking indoor and/or outdoor. This will be combined with functional task-exercises. The training will be conducted 2-3 times week, for at least two weeks or until they undergo surgery. During the remaining days, the participants will be instructed to follow the recommendation of 30 minutes of moderate physical activity per day, as well as to perform inspiratory muscle training.
15999227|NCT02895438|Dietary Supplement|gluten|
15999228|NCT02895425|Other|Registry (No intervention)|
15999229|NCT02895412|Biological|Donor-derived WT1-CTL and P-CTL|"Donor-derived WT1-CTL and P-CTL.
~P-CTL will be given prophylactically a minimum of 28 days after transplantation followed by administration of monthly infusions of WT1-CTL for up to four doses."
15999230|NCT02895399|Other|Cervico-Vaginal Smears analysis|Cervico-Vaginal Smears analysis
15999231|NCT02895386|Device|ROX Coupler|ROX Coupler will be used to create an anastomosis in the iliac region (between the iliac artery and vein).
15999232|NCT02895386|Other|Sham procedure|Sham procedure + continuing current antihypertensive medications.
15999233|NCT02895373|Drug|Alprostadil|5ng/kg/min, continuously, start within 24h of initiation of ECMO therapy and end at the end of ECMO therapy
15999234|NCT02895373|Drug|0.9% sodium chloride solution|continuously, start within 24h of initiation of ECMO therapy and end at the end of ECMO therapy
15999235|NCT02895360|Drug|BAL101553|BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle; oral capsule daily for one week during Cycle 2 (study days 15-21)
15999236|NCT02895360|Drug|BAL101553 at MTD|BAL101553 48-hour infusion on day 1, 8, and 15 of each 28-day cycle; treatment with maximum tolerated dose (MTD)
15999237|NCT02895347|Behavioral|Surgical Simulation Practice Modules|The surgical simulation practice modules simulate surgical settings for suturing.
15999238|NCT02895334|Behavioral|MyHeartBaby Program|Participating Caregivers will receive an electronic tablet loaded with a telemedicine intervention program (MyHeartBaby) to support caregivers remotely in the daily care and adjustment to having an infant with chronic medical needs with video-based telemedicine support services. There are a total of six sessions occurring at weeks 3, 6, 9, 12, and 15 of the study.
15999239|NCT02895321|Other|Cavex Bite&White ExSense|a water-based mint aroma gel containing hydroxyapatite and potassium nitrate.
15999240|NCT02895321|Other|Colgate, Protection Caries|a fluorine-based toothpaste gels
15999241|NCT02895321|Other|Placebo gel|a glycerin and water gel
15999242|NCT02895308|Behavioral|Online psychoeducation|The online intervention consists of a psychoeducation component taken from affect focused psychotherapy. In this model, emotions are physiological patterns that are shaped mainly in the context of previous relations. By using the model, patients are helped to better understand their current emotions, behaviors and cognitions. The aim of the intervention used in this study is to provide information about the six basic affects and how they may influence everyday behaviors and well-being in recurring patterns.
15999341|NCT02894606|Drug|Basiliximab Induction|The choice of the induction therapy is not a procedure of the study. This choice is made by the practioner, based on the graft recipient profile. This is a predefined group, the Basiliximab treatment is not an intervention in the study but must be considered as an exposure that is defined before the patient enters the study.
15999243|NCT02895308|Behavioral|Face-to-face psychoeducation|The intervention consists of a psychoeducation component taken from affect focused psychotherapy. In this model, emotions are physiological patterns that are shaped mainly in the context of previous relations. By using the model, patients are helped to better understand their current emotions, behaviors and cognitions. The aim of the intervention used in this study is to provide information about the six basic affects and how they may influence everyday behaviors and well-being in recurring patterns.
15999244|NCT02895295|Behavioral|Expert Recommendation|Decision support tool that provides personalized information on the financial implications of enrolling in different plans and expert recommendations of particular plans.
15999245|NCT02895295|Behavioral|Individual Analysis|Decision support tool that provides personalized information on the financial implications of enrolling in different plans.
15999246|NCT02895295|Behavioral|Usual Care|Study subjects randomized to the control arm will receive information on how to download their prescription drug information from their electronic medical record and provided with a list of resources available in the community to help them choose a prescription drug plan.
15999247|NCT02895269|Behavioral|Collaborative shared care|Collaboration between complementary alternative health providers and primary health care providers in the care of persons with psychosis.
15999248|NCT02895256|Drug|Any treatment for cluster headache|
15999249|NCT02895243|Other|Prehabilitation|The study will use a generic prehabilitation program which will include the following components: Warm-up, cardiovascular training, strength training, flexibility training, and cool down. Prehabilitation will occur once per week and approximately 1 hour in duration. Participants will take part in prehabilitation until they receive a kidney transplant which by study design is approximately for 3-6 months.
15999250|NCT02895230|Other|Standard care|An extraction from French Health Reimbursement Agency database and French hospital discharge database will be performed using a simplified request based on inclusion criteria but the extraction will encompass a 4-year period to ensure sufficient follow-up.
15999251|NCT02895217|Other|ergocycle|
15999252|NCT02895204|Dietary Supplement|Fermented Maillard reacted whey protein (F-MRP)|6g of powder containing 4.2g fermented maillard reacted whey protein
15999253|NCT02895204|Dietary Supplement|Placebo|6g of maltodextrin
15999254|NCT02895191|Drug|ulinastatin|Patients will receive the study drugs for 7 to 14 days
15999255|NCT02895191|Drug|placebo|Patients will receive the placebo for 7 to 14 days
15999256|NCT02895178|Behavioral|Combined aerobic and strength exercise training|Subjects participate in supervised exercise sessions for 60 minutes thrice weekly and are encouraged to participate in a home-based exercise session over 30 minutes once weekly for 12 weeks.
15999257|NCT02895152|Behavioral|Feedback|Will receive feedback on the amount of activity that has been undertaken in the last week, will specialist advice on steps taken, active minutes each day, how much device has been worn and tailored advice on how to improve activity levels
15999258|NCT02895139|Device|Additive Manufactured Orthotic Device|The 3D foot scan data will be used to generate a 3D model of the foot orthotic which will then be adapted to be suitable for solid printing. The final model will be saved in .stl format for use in the printing software. The additive manufactured orthotic insoles and all features or additions will be produced in a single build from additive materials matched for hardness to medium density EVA. Post production the orthotic will be cleaned to remove support material and a top cover will be attached to the final additive manufactured orthotic insole.
15999259|NCT02895139|Device|Moulded orthotic|The foam impression box and prescription will be sent to an external company for production of the handmade moulded orthotics. Handmade moulded orthotics will be produced by heating and wrapping medium density Ethylene-vinyl acetate (EVA) around plaster casts of the impression boxes. The orthotic insoles may be manually adapted to meet the requirements of the prescription, this could include cut out sections designed to offload regions of the foot or the addition of features such as metatarsal bars which provide varied support. Features and additions will be added in post manually by cutting and gluing onto the moulded orthotic insole. A top cover will be attached to the final moulded orthotic insole.
15999260|NCT02895139|Device|Milled orthotic|The 3D foot scan data will be used to generate a 3D model of the foot orthotic. This will then be saved in .pan format for use in a CNC milling software. Orthotics and all features will be milled in a single mill from a block of medium density EVA. Post milling the orthotics will be cleaned. The orthotic insoles may be manually adapted to meet the requirements of the prescription, this could include cut out sections designed to offload regions of the foot or the addition of features such as metatarsal bars which provide varied support. Features and additions will be added in post manually by cutting and gluing onto the milled orthotic insole. A top cover will be attached to the final milled orthotic insole.
15999261|NCT02895126|Behavioral|"Appui Parental program"|
15999262|NCT02895126|Behavioral|Regular parental support|
15999263|NCT02895113|Drug|Aspirin|Patients suffering from type 2 diabetes will be randomized to receive 100 mg/day or placebo for one year
15999264|NCT02895113|Other|Placebo|Patients in this arm will be treated with placebo
15999267|NCT02895087|Other|Diurnal Variation Group|This intervention occurs over one 24-hour period. Eligible participants will be required to be admitted into a supervised environment for 24-hours arriving no later than 0730. Blood draws will then be taken every 4 hours (0800, 1200, 1600, 2000, 2400 and 0400). Care will be taken to ensure the total blood draws (including the screening visit) stay within Red Cross Guidelines (less than 500 ml every 8 weeks).
15999268|NCT02895087|Other|External Stress Group|"2 visits will be required, each lasting approximately 2.5 hours in the afternoon.
~At both visits participants will rest quietly for 15 minutes, then have 3 blood draws and 4 saliva samples over approximately one hour. Participants will also be required to complete short questionnaires about their mood and experience.
~At the second visit, participants will also complete some thinking and talking tasks. In addition the autonomic nervous system of the participant's will be monitored throughout the visit."
15999342|NCT02894593|Other|alcohol free essential oils mouthwash|All subjects were instructed to rinse twice a day, in the morning and in the evening, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.
15999397|NCT02894125|Other|SPA Therapy|
16000337|NCT02886520|Device|PVDF transobturator tape|
15999269|NCT02895074|Procedure|Femtosecond laser-assisted cataract surgery|A femtosecond laser (Alcon-Lensx, Alcon-Lensx, Inc.) was used in this study. After pupil dilation and topical anesthesia, the laser was docked to the eye using a curved contact lens to applanate the cornea. With the integrated OCT imaging system, the locations of the cornea and the anterior and posterior surfaces of the crystalline lens were determined. A 5.0-mm-diameter capsulotomy was created by scanning a cylindrical pattern and followed by lens fragmentation. The laser was disconnected, and the remainder of the surgery was performed as phacoemulsification (Infiniti® Vision System; Alcon, USA). Folded intraocular lenses (IOLs) were implanted in the capsular bags.
15999270|NCT02895074|Procedure|Conventional phacoemulsification cataract surgery|Phacoemulsification was performed through a temporal 3.2-mm clear corneal incision with the same machine and followed by IOLs implantation.
15999271|NCT02895074|Drug|Tropicamide|After pupil dilation, 1 drop of tropicamide (0.5%) was applied every 15 minutes for 3 applications
15999272|NCT02895074|Drug|Proparacaine hydrochloride|topical anesthesia with proparacaine hydrochloride (0.5%) was applied.
15999273|NCT02895061|Drug|Alfacalcidol|Alfacalcidol 1 microgram/capsule
15999274|NCT02895035|Drug|Phenylephrine-ketorolac|Pehnylephrine-ketorolac is a combination of an alpha-one agonist (phenylephrine) and an NSAID (ketorolac). One 4-mL bottle of 1% phenylephrine/3% ketorolac is added to the irrigation solution during cataract surgery.
15999275|NCT02895035|Drug|Epinephrine|Epinephrine is a nonselective adrenergic agonist added to the irrigation solution during cataract surgery.
15999276|NCT02895022|Drug|Lidocaine 2% adrénalinée|
15999277|NCT02895022|Device|Epidural catheter|
15999278|NCT02895022|Procedure|Caesarean section|
15999279|NCT02895009|Device|experimental group|Participants allocated to the experimental group will receive a short term postoperative puncture site compression via TR Band. TR Band deflation is commenced at the 1st hour and completed at the 3rd hour, and the TR Band is removed at the 12th hour.
15999280|NCT02895009|Device|control group|Participants allocated to the control group will receive a routine long term postoperative puncture site compression via TR Band. TR Band deflation is commenced at the 2nd hour and completed at the 6th hour, and the TR Band is removed at the 24th hour.
15999281|NCT02894996|Drug|fluid challenge|fluid challenge realized after induction of anesthesia at a steady state, to assess fluid responsiveness and correct hypovolemia. The usual fluid bolus of 15ml/kg in 10 minute will be fragmented in 2 fluid boluses (3ml/kg in 2 minutes followed by measurement of hemodynamic parameter after 1 minute of the end of the 1st fluid bolus and followed by 12 ml/kg in 8 minutes then followed by measurement of hemodynamic parameters after one minute after the end of the 2nd fluid fragmented fluid challenge. Total administered: 15 ml/kg in 11 minutes. end of the study at 12 minutes.
15999282|NCT02894983|Other|Flexion-ulnar cast|The group will be treated with closed reduction and flexion-ulnar deviation position cast. This will take place under local anaesthesia by means of local infiltration commonly used in Finland. There is no preferable method for performing the reduction. Additional radiographs will be taken to verify the success of the reduction one week after the reduction and after two and five weeks of casting if treating health care professional it requires. The cast will be disposed after 5 weeks.
15999283|NCT02894983|Other|Functional cast|The group will be treated with closed reduction and functional position cast. This will take place under local anaesthesia by means of local infiltration commonly used in Finland. There is no preferable method for performing the reduction. Additional radiographs will be taken to verify the success of the reduction one week after the reduction and after two and five weeks of casting if treating health care professional it requires. The cast will be disposed after 5 weeks.
15999284|NCT02894970|Device|Pulmonary PPG|Five minutes check with a lights source with two wave lengths of infrared and a detector.
15999285|NCT02894957|Drug|Varenicline|: Patients will be randomized either to receive varenicline (uptitrated to 1 mg twice daily) for smoking reduction or smoke as usual for 4-6 weeks before quitting. After quit-day, the two groups will receive standard 12-week varenicline treatment. Non-treatment follow-up will continue to 6 months.
15999286|NCT02894944|Biological|Theragene®,Ad5-yCD/mutTKSR39rep-ADP|Theragene®,Ad5-yCD/mutTKSR39rep-ADP is Adenovirus-mediated Double Suicide Gene Therapy
15999287|NCT02894931|Dietary Supplement|monosaccharides|The monosaccharides; Glucose, Fructose, Galactose and mannose, will be administrated after O.N fasting, 50gr, once.
15999288|NCT02894931|Dietary Supplement|Disaccharides|The Disaccharides; Lactose, Maltose and sucrose, will be administrated after O.N fasting, 50gr, once.
15999289|NCT02894931|Dietary Supplement|Amino acids|The Amino acids; Leucine, Isoleucine, and Valine, will be administrated after O.N fasting, 5g, once.
15999290|NCT02894931|Dietary Supplement|Artificial Sweeteners|The Artificial sweeteners: Saccharin, Aspartame, Sucralose and Steviol, will be administrated after O.N fasting, 300 mg, once.
15999291|NCT02894931|Other|Control- water|Chilled water flavored with lemon juice as control
15999292|NCT02894918|Drug|Peginterferon alfa-2a|180ug/0.5ml,hypodermic injection once a week
15999293|NCT02894905|Drug|AL-335|Participants with various degrees of impaired renal function (mild [Cohort 1], moderate [Cohort 2], severe [Cohort 3]) and normal renal function (Cohort 4) will receive a single oral dose of AL-335 800 mg (given as 2*400-mg tablets).
15999294|NCT02894892|Drug|(A)Bismuth|
15999295|NCT02894892|Drug|(B)Bismuth|
15999296|NCT02894892|Drug|(C)Bismuth|
15999297|NCT02894892|Drug|(D)Esomeprazole and Bismuth|
15999298|NCT02894892|Drug|(E)Esomeprazole and Bismuth|
15999299|NCT02894892|Drug|(F)Esomeprazole and Bismuth|
15999300|NCT02894892|Other|(G)Control|
15999301|NCT02894879|Device|BreatheMAX®|"Modify chest physical therapy
~oscillated incentive spirometry (OIS) with inspiratory load of 5-8 cm H2O 30 times/set
~oscillated positive expiratory pressure (OPEP) with expiratory load of 5-8 cm H2O 30 times/set
~Coughing with splinting 3 times/set
~Chest mobilization with overhead both arms rises 10 times/set total 5 set/day"
15999302|NCT02894879|Other|Routine treatment|"Routine chest physical therapy
~Deep breathing exercise (upper and lower costal and diaphragmatic breathing exercise) as deep as possible for 10 times/set/level
~Coughing with splinting 3 times/set
~Chest mobilization with overhead both arms raised 10 times/set total 5 set/day"
15999343|NCT02894593|Other|alcohol essential oils mouthwash|All subjects were instructed to rinse twice a day, in the morning and in the evening, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.
15999303|NCT02894866|Device|hyperbaric oxygen|The hyperbaric oxygen treatment will be administered for 60 min in a baby hyperbaric oxygen chamber pressured with 100% oxygen to 1.5 to 1.8 atm absolute (ATA) and a constant oxygen flow was given to maintain the oxygen. concentration in the chamber at 80% or greater.The treatment will be administered once a day within 7 days after birth, 7 days is a course of treatment, at least for 4 courses.
15999304|NCT02894853|Genetic|Liquid (blood) biopsies and tumor biopsy (optional)|Liquid (blood) biopsies: 40 ml (maximal 10 times per patient) Tumor biopsy (optional)
15999305|NCT02894840|Biological|an inactivated influenza vaccine|The vaccine will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.
15999306|NCT02894840|Other|Placebo|The placebo will be administered via the intramuscular route; the preferred injection site will be the deltoid of the non-dominant arm.
15999307|NCT02894827|Biological|Blood sample|
15999308|NCT02894827|Other|Flow cytometry|
15999309|NCT02894827|Other|western blot|
15999310|NCT02894814|Behavioral|One-Stop Dispensing|Use of own medication, review of the patient's medication, partly or self-administration of medication during hospitalization under support from the health personnel to improve adherence, knowledge and feeling safe about the medication.
15999311|NCT02894814|Behavioral|One-Stop Dispensing and focused dialogue|Besides the elements of One-Stop Dispensing focused dialogue about the patient's medicine during hospitalization and at discharge to improve adherence, knowledge and feeling safe about the medication
15999312|NCT02894788|Other|ICU admission|
15999313|NCT02894749|Radiation|3D rotational angiography (3DRA)|3DRA allows CT-like reconstructions. It requires less X-rays and contrast medium than standard angioCT-scan. Furthermore, it can be performed in the operative room, during the procedure. Therefore, use of 3DRA should allow reduction of dose, contrast-medium and reintervention when compared to technical success assessment with angioCT-scan.
15999314|NCT02894736|Device|Soterix tDCS machine|Soterix tDCS machine - miniCT supervised neuromodulation system
15999315|NCT02894723|Dietary Supplement|L-arginine|30 ml arginoline contains 5 gr l-arginine
15999316|NCT02894723|Dietary Supplement|syrup|The same bottle of the experimental group, but without l-arginine
15999317|NCT02894710|Drug|Lidocaine 20mg/ml|Patients in Lidocaine group received an intravenous bolus injection of 1,5 mg/kg lidocaine (0,075mL/kg of Lidocaine 20mg/mL) followed by a continuous lidocaine infusion of 2 mg/kg/hr during surgery (0,1mL/kg/hr of Lidocaine 20mg/mL) and 1 mg/kg/hr in recovery room (0,05mL/kg/hr of Lidocaine 20mg/mL).
15999318|NCT02894710|Drug|Glucose 5% (placebo)|Patients in control group received an intravenous bolus injection of 0,075mL/kg of placebo (Glucose 5%) by a continuous lidocaine infusion of 0,1mL/kg/hr of placebo (Glucose 5%) during surgery and 0,05mL/kg/hr of placebo (Glucose 5%) in recovery room.
15999319|NCT02894697|Device|Angiography-guided PCI with BVS|Everolimus-eluting bioresorbable vascular scaffold (Absorb, Abbott Vascular, Santa Clara, CA, USA) was made from a bioabsorbable polylactic acid backbone which is coated with a more rapidly absorbed polylactic acid layer that contains and controls the release of the antiproliferative drug, everolimus. PCI will be performed with BVS under conventional coronary angiography without any other intravascular imaging modality. After PCI, postprocedural OCT will be evaluated to find OCT-defined suboptimal results requiring additional PCI. If there is OCT-defined suboptimization, additional PCI will be performed including balloon angioplasty or additional stent or BVS implantation for scaffold optimization. Further postprocedural OCT will be also evaluated whether scaffold implantation is fully optimized or not.
15999320|NCT02894697|Device|Optical coherence tomography-guided PCI with BVS|Everolimus-eluting bioresorbable vascular scaffold (Absorb, Abbott Vascular, Santa Clara, CA, USA) was made from a bioabsorbable polylactic acid backbone which is coated with a more rapidly absorbed polylactic acid layer that contains and controls the release of the antiproliferative drug, everolimus. For optimized PCI, both conventional coronary angiography and optical coherence tomography can be used before stent implantation. After PCI, postprocedural OCT will be evaluated to find OCT-defined suboptimal results requiring additional PCI. If there is OCT-defined suboptimization, additional PCI will be performed including balloon angioplasty or additional stent or BVS implantation for scaffold optimization. Further postprocedural OCT will be also evaluated whether scaffold implantation is fully optimized or not.
15999321|NCT02894684|Drug|Aztreonam|14 days of AZLI: 75mg TDS PLUS IV Colistin
15999322|NCT02894684|Drug|Standard Care|14 days of IV Colistin plus one of Tazocin/Ceftazidime/Meropenem/Aztreonam/Fosfomycin
15999323|NCT02894671|Other|blood exams|in serum will be analyzed the level of IMA, iron, transferrin, ferritin, total albumin
15999324|NCT02894658|Device|LipiFlow system|LipiFlow System is an in-office FDA approved treatment that relieves meibomian gland obstruction through the use of heat and pulsatile pressure.
15999325|NCT02894658|Procedure|Warm compresses|"Warm compresses will be applied to fellow eye and that eye will undergo daily treatment with eyelid scrubs using a warm wash cloth and no tears baby shampoo every morning and warm compresses on the eyelids for 5-10 minutes twice a day. Patients will be instructed on how to perform proper lid hygiene at the initial visit."
15999326|NCT02894645|Drug|Prednisolone|Oral
15999327|NCT02894645|Drug|Dexamethasone|Oral
15999328|NCT02894645|Drug|L-Asparaginase|Intramuscular injection
15999329|NCT02894645|Drug|Vincristine|Intravenous
15999330|NCT02894645|Drug|Methotrexate|Intrathecal/ Intravenous/ Oral
15999331|NCT02894645|Drug|Daunorubicin|Intravenous
15999332|NCT02894645|Drug|Doxorubicin|Intravenous
15999333|NCT02894645|Drug|Cyclophosphamide|Intravenous
15999334|NCT02894645|Drug|Cytarabine|Intravenous/ Subcutaneous injection
15999335|NCT02894645|Drug|6-Mercaptopurine|Oral
15999336|NCT02894645|Drug|Thioguanine|Oral
15999337|NCT02894645|Drug|Fludarabine|Intravenous
15999338|NCT02894645|Drug|Imatinib|Oral (For BCR-ABL ALL only)
15999339|NCT02894632|Device|MRI compatible motion sensor (MARMOT)|MRI with motion control (several motion sensors placed on the volunteer's body)
15999340|NCT02894606|Drug|Thymoglobulin Induction|The choice of the induction therapy is not a procedure of the study. This choice is made by the practioner, based on the graft recipient profile. This is a predefined group, the Thymoglobulin treatment is not an intervention in the study but must be considered as an exposure that is defined before the patient enters the study.
16000338|NCT02886520|Device|Polypropylene transobturator tape|
15999345|NCT02894593|Other|Placebo|All subjects were instructed to rinse twice a day, in the morning and in the evening, with 15 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.
15999346|NCT02894567|Device|Intraoperative test during a deep brain stimulation surgery|The spiderSTN lead is inserted in a selected track in the brain, and is connected to external neuro-recorder/stimulator . Once the intraoperative test phase is completed, the test devices are removed and the DBS surgery resumes.
15999347|NCT02894554|Drug|Telbivudine|
15999348|NCT02894554|Drug|Lamivudine|
15999349|NCT02894541|Drug|CKD-519 100mg|
15999350|NCT02894541|Drug|CKD-519 200mg|
15999351|NCT02894541|Drug|CKD-519 100mg|
15999352|NCT02894541|Drug|CKD-519 200mg|
15999353|NCT02894528|Drug|BioMend and ReproBone|Post-extraction sockets was filled by synthetic bone substitute ReproBone, and after the sockets were covered by a resorbable collagen membrane BioMend, which in turn was covered by a flap.
15999354|NCT02894528|Drug|BioMend without ReproBone|Post-extraction the socket was filled only by clot and covered by a resorbable collagen membrane BioMend, which in turn was covered by a flap.
15999355|NCT02894515|Drug|Idalopirdine commercial tablet (test)|single dose, 10 mg, oral
15999356|NCT02894515|Drug|Idalopirdine clinical tablet (reference)|single dose, 10 mg, oral
15999357|NCT02894502|Behavioral|Motivational interviewing|The intervention will consist of a brief session of motivational interviewing (MI) performed by a trained nurse. During MI, the interventionist will address one or two aspects of self-care that the participants want to address. After this first intervention, the same interventionist will contact the participant by telephone to improve the first intervention and provide further support as needed. These telephone contact will be done three times at two week intervals following the first intervention (for a total of two months). Patients and caregivers that receive the intervention also will be given informational material on HF management that is consistent with international guidelines.
15999358|NCT02894489|Device|corneal lenses|wear corneal lenses on daily basis
15999359|NCT02894489|Device|large diameter lenses|
15999360|NCT02894463|Other|questionnaire|
15999361|NCT02894450|Other|blood test|bioassay xaban
15999362|NCT02894437|Other|qualitative interviews|semi-structured interviews as a conceptual frame work
15999363|NCT02894398|Drug|Palbociclib|"Capsules (commercially available, obtained from local pharmacies), 125mg daily, 21 days, 7 days off, cycles of 28 days.
~Dose reductions: 100mg, 75mg (no change in administration schedule) Number of cycles: until disease progression, intolerable toxicity, death or any other reasons"
15999364|NCT02894398|Drug|Letrozole|Letrozole will be administered as basic therapy (commercially available tablets, obtained from local pharmacies) as followed: 2.5mg/daily, oral intake
15999365|NCT02894398|Drug|Anastrozole|Anastrozole will be administered as basic therapy (commercially available tablets, obtained from local pharmacies) as followed: 1mg/daily, oral intake
15999366|NCT02894398|Drug|Exemestane|Exemestane will be administered as basic therapy (commercially available tablets, obtained from local pharmacies) as followed: 25mg/daily, oral intake
15999367|NCT02894398|Drug|Fulvestrant|Fulvestrant will be administered as basic therapy (commercially available injection, obtained from local pharmacies) as followed: 500mg/once monthly, intramuscular injection
15999368|NCT02894385|Drug|BAY1841788|600 mg single dose, administered as 2 x 300 mg tablets on Day 00.
15999369|NCT02894372|Device|Oral spray 1|Research participants got topical oral spray immediately after surgery (hospital patients) and from the first doctor visit with pharyngeal disease (clinic outpatients).
15999370|NCT02894372|Device|Oral spray 2|Research participants got topical oral spray immediately after surgery (hospital patients) and from the first doctor visit with pharyngeal disease (clinic outpatients).
15999371|NCT02894359|Device|cone beam imagery of cervical spine|
15999372|NCT02894346|Other|Teachers|Teachers are exposed to the WTMST survey that based on the theory of Self-Determination (SDT) will categorize them according to the elements of the SDT: Intrinsic, identified, introjected, external and a motivation.
15999373|NCT02894333|Behavioral|behavioral observation|
15999374|NCT02894320|Behavioral|Behavioral observation|
15999375|NCT02894307|Drug|Rivaroxaban|In patients with mechanical valves and unstable INR
15999376|NCT02894294|Other|implementation of seasonal malaria chemoprevention|administration of therapeutic doses of antimalarials (Sulfadoxine-pyrimethamine [SP] + Amodiaquine [AQ]) at monthly intervals during the high malaria transmission season in children 3-59 months of age.
15999377|NCT02894281|Device|pupillary light reflex|measure with infra-red cameras
15999378|NCT02894268|Drug|Doxycycline|Doxycycline 100g po bid
15999379|NCT02894268|Drug|Furazolidone|Furazolidone 100mg po bid
15999380|NCT02894268|Drug|Esomeprazole|Esomeprazole 20mg po bid
15999381|NCT02894268|Drug|Colloidal Bismuth Subcitrate|Bismuth 20mg po bid
15999382|NCT02894268|Drug|Sensitivity antibiotics|Two antibiotics based on antibiotic sensitivity of H.pylori culture, including amoxicillin, clarithromycin, metronidazole, levofloxacin, tetracycline and furazolidone.
15999383|NCT02894255|Device|Coronary artery bypass grafting|
15999384|NCT02894255|Procedure|Percutaneous coronary intervention|
15999385|NCT02894242|Device|F&P Deimos Nasal Pillows Mask|Investigative Nasal Pillows Mask to be used for OSA therapy
15999386|NCT02894229|Behavioral|Mindfulness Based Stress Reduction|A modified version of traditional MBSR. The current study's version of MBSR is shortened to 6-weeks.
15999387|NCT02894229|Behavioral|Cognitive-Behavioral Therapy (CBT) Group|A 6-week, 2-hour per group, skills group that focuses on various cognitive-behavioral skills for stress reduction (e.g., progressive muscle relaxation; cognitive restructuring).
15999388|NCT02894216|Procedure|radionuclide shuntography|the investigators retrospectively enrolled patient who received radionuclide shuntography
15999389|NCT02894203|Behavioral|Mindfulness|
15999390|NCT02894203|Behavioral|Yoga|
15999391|NCT02894177|Procedure|tcPCO2 measurement|tcPCO2 continuous monitoring during spontaneous breathing trials
15999392|NCT02894164|Other|No intervention|
15999393|NCT02894151|Drug|Depot medroxyprogesterone acetate|
15999394|NCT02894151|Device|LNG-IUS|
15999395|NCT02894138|Drug|alteplase|
15999396|NCT02894138|Drug|Placebo|
15999399|NCT02894112|Dietary Supplement|carbohydrate control beverage|1 serving of carbohydrate control beverage (Carbohydrate powder + water)
15999400|NCT02894112|Dietary Supplement|caloric control beverage|1 serving of caloric control beverage (carbohydrate powder + protein powder + water)
15999401|NCT02894099|Other|Prolonged sitting time|Volunteers will be continuously sitting on a chair for 5 hours and should move the least possible. If the participant needs to stand from the chair, the stage will be invalidated.
15999402|NCT02894099|Other|PST+Light intensity Short bouts PA|Volunteers will have their time sitting interrupted every 20 minutes for 2 minutes of physical activity of low intensity. In the active period, participants will be encouraged to walk in the hallway and reach a training heart rate between 50-60% HR max predicted for the age and measured by heart rate monitor. The Borg scale will be used at the beginning and the end of each active period in order to measure the subjective effort of the participants. In the end the volunteers will be sitting 5 hours and have 30 minutes (15 bouts of 2 minutes) of light intensity physical activity.
15999403|NCT02894099|Other|PST+Moderate intensity Short bouts PA|Volunteers will have their time sitting interrupted every 20 minutes for 2 minutes of physical activity of moderate intensity. In the active period, participants will be encouraged to walk in the hallway and reach a training heart rate between 65 a 75% HR max predicted for the age and measured by heart rate monitor. The Borg scale will be used at the beginning and the end of each active period in order to measure the subjective effort of the participants. In the end the volunteers will be sitting 5 hours and have 30 minutes (15 bouts of 2 minutes)of moderate intensity physical activity.
15999404|NCT02894099|Other|PST+Moderate intensity Long bouts PA|Volunteers will have their time sitting interrupted every 75 minutes for 10 minutes of physical activity of moderate intensity. In the active period, participants will be encouraged to walk in the hallway and reach a training heart rate between 65 a 75% HR max predicted for the age and measured by heart rate monitor. The Borg scale will be used at the beginning and the end of each active period in order to measure the subjective effort of the participants. In the end the volunteers will be sitting 5 hours and have 30 minutes (3 bouts of 10 minutes) of moderate intensity physical activity.
15999405|NCT02894086|Other|database.|database
15999406|NCT02894073|Device|skin transilluminator|VeinViewer
15999407|NCT02894060|Other|blood tests|"Blood tests done by the nurse in the CRC (clinical research center). The quantity of blood taken wil be (3 5-mL tubes):
~2 plain tubes and 1EDTA tube Arterial blood pressure will be measured at the CRC. Then, an X-ray of the profile of the abdomen will be taken without preparation to evaluate aortic calcification (in the radiology department of the Amiens hospital)"
15999408|NCT02894047|Biological|blood|measurement of CaSR expression levels on synovial fluid monocytes
15999409|NCT02894021|Procedure|classic closure|mastectomy with classic closure in 2 steps, drainage by negative pressure aspiration
15999410|NCT02894021|Procedure|padding|areas of padding and running sutures between subcutaneous tissue and pectoral muscle followed by closure in 2 steps, drainage by negative pressure aspiration for 48 h
15999411|NCT02894008|Drug|ChAd63-KH|ChAd63-KH in adults and adolescents with persistent PKDL.
15999412|NCT02893995|Drug|Slow Dose Titration Group of Subcutaneous Treprostinil|subcutaneous treprostinil
15999413|NCT02893995|Drug|Rapid Dose Titration Group of Subcutaneous Treprostinil|subcutaneous treprostinil
15999414|NCT02893982|Radiation|brachytherapy|image-guided navigation of catheter placement for high dose rate (HDR) brachytherapy treatment of patients with primary liver lesions
15999415|NCT02893969|Behavioral|Physical Activity|After 72 hours of full physical rest patients will gradually reintroduce physical activity into their daily routine.
15999416|NCT02893969|Behavioral|Rest|Complete physical rest until asymptomatic.
15999417|NCT02893956|Procedure|echocardiography with postural support|
15999418|NCT02893956|Procedure|echocardiography with standard condition (usual)|
15999419|NCT02893943|Dietary Supplement|Probiotics|
15999420|NCT02893943|Dietary Supplement|Placebo|
15999421|NCT02893930|Drug|Sapanisertib|Given PO
15999424|NCT02893904|Device|EEG monitoring|Steady state concentrations periods of Propofol for EEG data analyzes. Remifentanil was administrated at constant rate in all patients.
15999425|NCT02893904|Device|Target Controlled Infusion|Steady state effect site concentrations of remifentanil administrated to all patients.
15999426|NCT02893891|Procedure|Laparoscopic sleeve gastrectomy|Sleeve gastrectomy involves removing most of the stomach, limiting the amount of food the patient can eat.
15999427|NCT02893891|Procedure|Laparoscopic gastric plication|Laparoscopic gastric plication involves sewing one or more large folds in the stomach. During the laparoscopic gastric plication, the stomach volume is reduced about 70%, which makes the stomach able to hold less and helps the patient eat less.
15999428|NCT02893891|Procedure|Intragastric balloon|The introduction of the balloon is non-invasive as it is inserted endoscopically (down the oesophagus). The balloon is then filled inside the stomach with a dyed physiological solution, which reduces the volume of the stomach.
15999429|NCT02893891|Device|Intragastric balloon implantation|Intragastric balloons (End-Ball, Medsil) will be implanted in the patients with morbid obesity.
15999430|NCT02893878|Other|Vaccine safety surveillance|Extraction of routinely collected primary care data from approximately 10 volunteer English general practices by using an improved card-based ADR reporting system to estimate proportions of AEIs among seasonal influenza-vaccinated individuals.
15999433|NCT02893852|Behavioral|standard CO-OP Approach|The CO-OP protocol originally developed by Mandich and Polatajko (2004) comprises 12 sessions. The therapist teaches the participants a global cognitive strategy: GOAL - PLAN - DO - CHECK. The participants use the global strategy and cooperate to learn specific strategies to solve each task performance breakdown identified through Dynamic Performance Analyses (DPA). The therapist uses DPA at pre-intervention and throughout the sessions and mediational techniques to guide participants to use GOAL-PLAN-DO-CHECK to discover specific strategies to solve performance problems and to support generalization and transfer of skills.
16069082|NCT02389868|Drug|Lovastatin|
15999434|NCT02893852|Behavioral|standard CO-OP Approach plus coaching parents|CO-OP Approach with parents coaching groups will include an addition of four extra coaching groups sessions for parents to provide additional information to supplement their knowledge on CO-OP (how to use GOAL-PLAN-DO-CHECK at home; how to use dynamic performance analysis to support their children's' performance solutions; to talk about their experiences with their children at home).
15999435|NCT02893839|Other|Prick to prick test|
15999436|NCT02893826|Drug|EG-1962 (nimodipine microparticles)|
15999437|NCT02893826|Drug|Enteral Nimodipine|
15999438|NCT02893800|Device|Locating system watch with GPS-technology|Patients using locating system watches with embedded global positioning system (GPS) technology and telephone function; Caregivers using a Smartphone with an installed application to see the current location of the patient and with the possibility to call the patient
15999439|NCT02893787|Other|Speckle Tracking Echocardiography|Echocardiography analyses
15999440|NCT02893774|Other|quality of life assessment|"All patients with breath cancer or melanoma will have quality of life assessment 1, 6, 12, 24, 48 and 60 months after the initial cancer diagnosis.
~Those assessment will use standardized quality of life questionnaire :
~QLQ-C30
~SWLS (Satisfaction with Life Scale)
~PTGI (Post-Traumatic Growth Inventory)
~HADS (Hospital Anxiety and Depression Scale)
~Brief COPE
~MHLCS (Multidimensional Health Locus of Control Scale)"
15999441|NCT02893748|Device|HyGIeaCare Prep|Patients will receive the HyGIeaCare Prep, which is an open colon lavage system using warm water by gravity drip to evacuate the colon by stimulating peristalsis to cleanse the colon prior to colonoscopy.
15999442|NCT02893748|Procedure|Colonoscopy|Screening colonoscopy as per standard of care.
15999443|NCT02893748|Drug|polyethylene glycol (PEG)|PEG preparation to be delivered in two doses - 1/2 the night before and 1/2 the morning of the colonoscopy
15999444|NCT02893735|Other|Charisma-Diamond|The surfaces were etched using 35% phosphoric acid for 30 s. The etched surfaces were rinsed and dried. Nano-hybrid resin composite system was used Charisma-Diamond in combination Gluma2 Bond etch&rinse adhesive. The composite increments were carefully placed between the matrix strip and tooth by using a hand instrument. The composite resin restorations were light-cured (600 mW/cm²). Occlusion was checked with thin articulating papers. Restoration surfaces were finished and polished with fine finishing diamond burs, stones and rubber cups whereas; proximal and labial surfaces were contoured and polished with finishing strips. The treatments were completed by instructing the patients about the oral hygiene measures for cleaning their restorations with toothbrush and dental floss.
15999445|NCT02893735|Other|Filtek-Z550|The surfaces were etched using 35% phosphoric acid for 30 s. The etched surfaces were rinsed and dried. Nano-hybrid resin composite system was used Filtek-Z550 in combination with Adper™ Single Bond 2 etch&rinse adhesive. The composite increments were carefully placed between the matrix strip and tooth by using a hand instrument. The composite resin restorations were light-cured (600 mW/cm²). Occlusion was checked with thin articulating papers. Restoration surfaces were finished and polished with fine finishing diamond burs, stones and rubber cups whereas; proximal and labial surfaces were contoured and polished with finishing strips. The treatments were completed by instructing the patients about the oral hygiene measures for cleaning their restorations with toothbrush and dental floss.
15999446|NCT02893722|Drug|atosiban|give drugs 30 minutes before the start of the embryo transfer,and intravenous infusion in total dose of 37.5 mg is set in certain infusion rate, and complete the infusion in 3 hours.
15999447|NCT02893722|Drug|0.9% saline|give drugs 30 minutes before the start of the embryo transfer,and intravenous infusion is set in the same rate with experimental group, complete the infusion in 3 hours.
15999448|NCT02893709|Drug|Omeprazole|Oral administration of omeprazole at therapeutic dose (20 mg daily) for a duration of 7 days
15999449|NCT02893696|Other|Various sitting time|Various sitting time
15999450|NCT02893683|Other|Paris Visual Learning Test|
15999451|NCT02893670|Procedure|Radiologic (MRE) or endoscopic (sigmoidoscopy) evaluation|"All patients will be assessed for drug levels and metabolites. Patients diagnosed with ileal or ileo-colonic crohn's will undergo an MR Enterography (MRE). In crohn's patients, MRE was shown to have a higher impact on patient management than colonoscopy. Patients diagnosed with either UC, IBD-U or Crohn's colitis will undergo a flexible sigmoidoscopy.
~Following re-evaluation each patient will undergo 2 transition meetings with pediatric and adult gastroenterologist as well as a meeting with IBD nurses and social worker."
15999452|NCT02893618|Drug|Diazoxide choline controlled-release tablet|QD tablet formulation of choline salt of diazoxide
15999453|NCT02893579|Behavioral|Early SR intervention|Self-directed stress reduction program delivered through a smart-phone application
15999454|NCT02893579|Behavioral|Delayed SR intervention|Activity tracking only for the first month
15999455|NCT02893566|Behavioral|Mi Band Step Challenge|
15999456|NCT02893553|Drug|Midodrine Hydrochloride|study 1 will be single blind. study 2 will be blinded randomized-control trial.
15999457|NCT02893553|Drug|Pyridostigmine Bromide|study 1 will be single blind. study 2 will be blinded randomized-control trial.
15999458|NCT02893553|Drug|Mirabegron|study 1 will be single blind. study 2 will be blinded randomized-control trial.
15999459|NCT02893553|Other|Placebo|placebo will only be used for study arm 2, the randomized blinded phase.
15999460|NCT02893540|Drug|Capecitabine|we are going to compare two maintenance treatment models with capecitabine in this study
15999461|NCT02893527|Behavioral|personalized coaching|personalized coaching coordinated by a coordinating nurse on a shutdown period of 8 months (consecutive stops).
15999462|NCT02893514|Other|Screening Only (SO) condition|Patient and PCP are not presented with screening results. The PCP does not receive clinical decision support, or clinical reminders.
15999509|NCT02893332|Radiation|Radiation: SBRT|A first line TKI (Gefitinib 250mg po qd or Tarceva 150mg po qd ) will be administered according to the standard dosing of the drug for metastatic NSCL during a 1-week run-in period after which SBRT will be delivered to the all oligometastatic lesions concurrently with the TKI. The SBRT dose will be , ranging from at 25Gy (5 Gy per fraction) to 40 Gy (8 Gy per fraction).
15999510|NCT02893332|Drug|TKI (Gefitinib or Tarceva )|A first line TKI (Gefitinib 250mg po qd or Tarceva 150mg po qd ) will be administered according to the standard dosing of the drug for metastatic NSCL, no local therapy apply to oligo-metastatic sites.
15999511|NCT02893319|Behavioral|Feeding and growth differences, 5oz vs 8oz bottle|Group A: 5oz bottle Group B: 8oz bottle
16069897|NCT02383810|Drug|Placebo|
15999463|NCT02893514|Other|SUSIT Condition|Following completion of substance use screening, the tablet computer presents screening results (including level of risk) to the patient for each substance used, asks them to identify their drug of most concern (DOMC), and assesses readiness and confidence to change behavior. Results are delivered to the PCP at the point of care, paired with clinical decision support tailored to the patient's screening results. This information is delivered on the tablet computer, which is handed to the PCP by a Medical Assistant. CDS guides the PCP through a brief intervention specific to the DOMC, recommends clinical actions pertaining to the substance and risk level, and generates a printed summary for the patient. At each scheduled follow-up medical visit, the PCP receives a clinical reminder containing a summary of the patient's substance use and level of risk, paired with CDS that guides them through a follow-up brief intervention.
15999464|NCT02893488|Drug|DTG/ABC/3TC FDC DISPERSIBLE TABLET|DTG/ABC/3TC FDC dispersible tablet
15999465|NCT02893488|Drug|EPZICOM (ABC/3TC)|"EPZICOM will be available as orange, film coated, modified capsule shaped tablets, debossed with GS FC2 on one side."
15999466|NCT02893488|Drug|TIVICAY (DTG)|TIVICAY will be available as white, round, biconvex tablets
15999467|NCT02893449|Behavioral|Social adaptation|"Questionnaire to fill-in.
~The structured program of preoperative cognitive remediation is divided in 3 parts: one interview with the patient to do a building of the subjective theories (difficulties due to the disease, hope relative to the intervention), a study meeting of the cognitive remediation possibilities and a cognitive remediation meeting with the patient. The spouse will be included in the program."
15999468|NCT02893449|Behavioral|Intensive care management|In this group, the structured program of the SICRPPD group will be replaced by 3 unstructured psychiatric interviews during which patients will be assessed for their perception of the disease and the upcoming surgery. This group will allow to control for the intrinsic effect of the preoperative management independently of the remediation itself.
15999469|NCT02893449|Procedure|Deep brain stimulation|
15999470|NCT02893436|Procedure|Surgery with tracheal intubation curarisation|
15999471|NCT02893423|Drug|Ropivacaine|Using 2 Different Concentrations of Ropivacaine in Tap Block for Postoperative Analgesia for C-Section Patients
15999472|NCT02893397|Device|Activity Monitor|Wear a fitbit
15999473|NCT02893397|Behavioral|Exercise Intervention|Undergo supervised exercise sessions
15999474|NCT02893384|Drug|Local Anesthetic Injection above the serratus anterior|This is a quantitative pilot study assessing whether a new technique of local anesthesia injection during mastectomy surgery gives better pain outcomes than the standard methods. Patients who meet inclusion criteria will be invited to partake and all patients will have the injection technique. These patients will then be monitored for pain outcomes up to 7 days following the surgery and the results compared with historical results from patients who have already had the surgery.
15999475|NCT02893371|Drug|Lithium Carbonate|Exposure to all dosages and delivery forms.
15999476|NCT02893371|Drug|Lamotrigine|Exposure to all dosages and delivery forms.
15999477|NCT02893371|Drug|Valproic Acid|Exposure to all dosages and delivery forms.
15999478|NCT02893371|Drug|Oxcarbazepine|Exposure to all dosages and delivery forms.
15999479|NCT02893371|Drug|Carbamazepine|Exposure to all dosages and delivery forms.
15999480|NCT02893371|Drug|Ziprasidone|Exposure to all dosages and delivery forms.
15999481|NCT02893371|Drug|Risperidone|Exposure to all dosages and delivery forms.
15999482|NCT02893371|Drug|Quetiapine|Exposure to all dosages and delivery forms.
15999483|NCT02893371|Drug|Olanzapine|Exposure to all dosages and delivery forms.
15999484|NCT02893371|Drug|Aripiprazole|Exposure to all dosages and delivery forms.
15999485|NCT02893371|Drug|Fluoxetine / Olanzapine|Exposure to all dosages and delivery forms.
15999486|NCT02893371|Drug|Haloperidol|Exposure to all dosages and delivery forms.
15999487|NCT02893371|Drug|Perphenazine|Exposure to all dosages and delivery forms.
15999488|NCT02893371|Drug|Clozapine|Exposure to all dosages and delivery forms.
15999489|NCT02893371|Drug|Asenapine|Exposure to all dosages and delivery forms.
15999490|NCT02893371|Drug|Lurasidone|Exposure to all dosages and delivery forms.
15999491|NCT02893371|Drug|Paliperidone|Exposure to all dosages and delivery forms.
15999492|NCT02893371|Drug|Mirtazapine|Exposure to all dosages and delivery forms.
15999493|NCT02893371|Drug|Bupropion|Exposure to all dosages and delivery forms.
15999494|NCT02893371|Drug|Desvenlafaxine|Exposure to all dosages and delivery forms.
15999495|NCT02893371|Drug|Duloxetine|Exposure to all dosages and delivery forms.
15999496|NCT02893371|Drug|Venlafaxine|Exposure to all dosages and delivery forms.
15999497|NCT02893371|Drug|Citalopram|Exposure to all dosages and delivery forms.
15999498|NCT02893371|Drug|Escitalopram|Exposure to all dosages and delivery forms.
15999499|NCT02893371|Drug|Fluoxetine|Exposure to all dosages and delivery forms.
15999500|NCT02893371|Drug|Fluvoxamine|Exposure to all dosages and delivery forms.
15999501|NCT02893371|Drug|Paroxetine|Exposure to all dosages and delivery forms.
15999502|NCT02893371|Drug|Sertraline|Exposure to all dosages and delivery forms.
15999503|NCT02893371|Drug|Vilazodone|Exposure to all dosages and delivery forms.
15999504|NCT02893371|Drug|Doxepin|Exposure to all dosages and delivery forms.
15999505|NCT02893358|Drug|Allisartan Isoproxil|Allisartan Isoproxil 80mg once daily taken in the morning during 8:00-9:00. To achieve the target blood pressure allisartan isoproxil may be doubled to 160mg once a day. If necessary, amlodipine 2.5mg may be combined with allisartan isoproxil. Duration: 12 months.
15999506|NCT02893358|Drug|Placebo|Corresponding placebo once daily taken in the morning during 8:00-9:00. Duration: 12 months.
15999507|NCT02893345|Behavioral|Safe@Home Intervention Group|For the 8 training visits, participants may select to work on skills in 2 of 5 activity modules: Improving mobility, balance and strength; Managing health and wellness; Staying On Your Own at Home; Maintaining the home; Getting out in the community. Participants may seek single service rehabilitation, medical, and psychological care as usual.
15999508|NCT02893345|Other|Usual Care Group|Persons can set goals and work on activities with or without a family member as they so choose. Participants may seek single service rehabilitation, medical, and psychological care as usual.
15999750|NCT02891382|Behavioral|Shared Reward|Patients with diabetes and their companion support will each receive 50% of the cash reward.
15999512|NCT02893306|Biological|MSCs|origin: bone marrow of healthy donor; manipulation: ex vivo expanded; via: intravenous; vehicle: 5% human recombinant albumin in physiological serum; dose: 2-3 millions/Kg; dosage: single
15999513|NCT02893293|Drug|Ferumoxytol-enhanced magnetic resonance imaging|Eligible patients receive a single ferumoxytol-dose and follow-up magnetic resonance imaging to evaluate success of stem cell transplant
15999514|NCT02893293|Device|Magentic Resonance Imaging|Both arms will receive MRI
15999515|NCT02893280|Drug|aspirin, clopidogrel, statin, enoxaparin, streptokinase|Acute coronary syndrome treatment
15999516|NCT02893267|Device|Peripheral Nerve Stimulation|The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad has an embedded power source but also serves as the anode. The 1-channel stimulator outputs a biphasic current waveform with current pulse parameter ranges suitable for PNS. The percutaneous lead is inserted using an introducer (like a hypodermic needle) which is withdrawn and the lead is retained in the muscle by a barb at its tip. After a 1-week stabilization period, stimulation is initiated (6 hrs/day). The duty cycle and daily dose remain constant, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period is 3 weeks after which the lead will be removed. Total time of electrode implantation is no more than 29 days.
15999517|NCT02893267|Other|Physical Therapy|Participants will receive 8 60-minute sessions of outpatient therapy over a 4 week period concurrent with PNS or sham-PNS treatment. Therapy may include: Proper Positioning and Handling, Therapeutic positioning and Strengthening Exercises, Mirror Therapy, Task-specific Therapy, Home Exercise Program, and a Mental Practice program.
15999518|NCT02893267|Other|Sham-PT|Participants randomized to sham-PT will receive 8 60-minute sessions with therapists with the goal of controlling for the effect of regular contact with a therapist and study staff in a therapeutic environment. Participants will undergo a hands-on evaluation and re-evaluation before and after treatment. Therapists will provide sham ultrasound therapy and light application of inert gel to the shoulder for 10 minutes, Pre-Gait Training or Gait training, Exercise therapy, and relaxation therapy.
15999519|NCT02893267|Device|Sham-PNS|The stimulation system includes an external stimulator, percutaneous lead and pad. The stimulator snaps onto the pad. The pad has an embedded power source.The stimulator will appear to function as normal though will not deliver electrical current to the electrode. The subjects will be prescribed 6 hours of sham-stimulation per day for 3 weeks.
15999520|NCT02893254|Drug|IBI303|12 cycles. IBI303: 40 mg, iH
15999521|NCT02893254|Drug|Adalimumab|12 cycles. Adalimumab: 40mg, iH
15999522|NCT02893241|Drug|Cafedrine/theodrenaline|
15999523|NCT02893241|Drug|Ephedrine|
15999524|NCT02893228|Procedure|Saline|At the location chosen for interscalene block the needle tip will be positioned anterior to the anterior scalene muscle. At this point 10ml of 0.9% saline will be injected.
15999525|NCT02893228|Drug|Levobupivacaine|the needle tip will then be positioned between C5 and C6 nerve roots. At this location, 20 ml of 0.25% levobupivacaine will be injected in 5 ml increments with intermittent aspiration. The needle tip will not be repositioned unless the patient complaints of paraesthesia
15999526|NCT02893215|Other|Screening for silent AF with Zenicor thumb-ECG|Each patient has a device for 14 days, which monitorizes their heart rhythm. They send the ecg four times daily.
15999527|NCT02893202|Other|Therapeutic Horseback riding|An 8-week equine-assisted program designed to especially for veterans. The curriculum consists of eight 90-minute sessions designed to teach basic horse care and riding skills along with communication skills.
15999528|NCT02893189|Genetic|Infusion of modified CAR19 T-cells (4G7-CARD T-cells)|The original stem cells donor (or if not available the patient) will undergo unstimulated leucapheresis for generation of the Advanced Therapy Interventional Medicinal Product (ATIMP) 4G7-CARD T-cells. Escalating doses of the ATIMP will then be infused to the patient depending on outcome and any experienced side effects.
15999529|NCT02893176|Drug|macitentan|
15999530|NCT02893176|Drug|placebo (for macitentan)|
15999531|NCT02893163|Behavioral|CHANGE Intervention|Canadian Health Advanced by Nutrition and Graded Exercise Protocol
15999532|NCT02893163|Other|Usual Care|Usual Care by Family Doctor
15999533|NCT02893150|Behavioral|TAU|"TAU (Treatment as Usual), individuals presenting with overweight (BMI of 25 kg/m ² to 29.9 kg/m ²), but without comorbidities, teams of primary care (PC) organized care plans to return to the track of normal BMI (BMI of 18.5 kg/m ² to 24.9 kg/m ²).
~For those who have comorbidities such as hypertension and diabetes, in addition to including individuals in group activities, evaluates the need for individual dietary prescription by the nutritionist. This decision is discussed among the team of PC and Matrix support team"
15999534|NCT02893150|Behavioral|TAU+MBHP|"TAU (Treatment as Usual) + MBHP. We used a general (general vulnerability, not specific) mindfulness-based intervention (MBI) developed by our research group, an 8-week-group-based MBI called Mindfulness-Based Health Promotion (MBHP) program . It is based on the original model developed by Jon Kabat-Zinn and colleagues (MBSR), and subsequently adapted by our research group in order to fit it better into the context and needs of Primary Care (PC) and national and local Health Systems, which has been applied by the Center Mente Aberta in Brazil (www.mindfulnessbrasil.com), and by the University of Zaragoza, in Spain (www.webmindfulness.com). One of the sessions (the sixth one) is developed in silence, with the goal of deepening the mindfulness practice; more feasible to be implement in health services and facilities"
15999535|NCT02893150|Behavioral|TAU+MB-EAT|TAU (Treatment as Usual) + MB-EAT (mindfulness-based eating awareness training). Adapted from the MBSR, Mindfulness-based Eating Awareness Training (MB-EAT) or awareness training. This program was specially developed for the compulsive eating disorders and related problems[47]. In addition the four main techniques of meditation mentioned in the MBHP program includes modifications to these basic techniques, and include experimentation with different flavors, sweet and savory foods, etc. Has 10 weekly sessions of 2,5h
15999536|NCT02893137|Device|Optune|For further information see www.optune.com
15999537|NCT02893137|Procedure|Craniectomy|A small hole is placed in the skull between the tumor and the closest Optune electrode. The position and geometry of the craniotomy is determined by computersimulation of the electric field induced by Optune therapy. Craniotomy is a surgical procedure, which is carried out under general anaesthesia.
15999538|NCT02893124|Drug|peginterferon alfa|peginterferon alfa-2a 180 micrograms/week or peginterferon alfa-2b 80 micrograms/week, for at most 96 weeks.
15999751|NCT02891369|Other|No intervention. Descriptive study|
16070210|NCT02381431|Device|FLIR ONE|
15999539|NCT02893111|Drug|Bortezomib|Bortezomib will be subcutaneously applicated in 4 treatment cycles with 4 injections of 1 mg Bortezomib /m2 body surface per cycle
15999540|NCT02893098|Drug|Humia inj.|"Single injection of 3mL Humia inj.
~Dummy: Single injection 2ml Normal Saline inj. given weekly for 2 weeks"
15999541|NCT02893098|Drug|High hyal Plus inj.|Single Injection of 2mL High hyal Plus inj. given weekly for 3 weeks
15999542|NCT02893085|Biological|bile sample analysis|tumor mutation profile tumor genotype
15999543|NCT02893085|Biological|biochemical markers, VEGF and MMPs, in bile samples|
15999544|NCT02893072|Behavioral|Individualized medical nutrition therapy|The intervention group involves dietary and exercise advice and monitoring.
15999545|NCT02893046|Other|No intervention|
15999546|NCT02893033|Device|repetitive transcranial magnetic stimulation|rTMS
15999547|NCT02893007|Other|Brief family-centered care (BFCC) program|The therapist provided the 4-session BFCC program twice a week for each dyad. The core principles treated family as a single unit and provided individually tailored interventions to improve family function through psychoeducation, social and emotional support, and actively raising questions to facilitate constructive awareness and changes. It was initially held to assess family function, then to provide information about BPD, to support and empower the dyads to change communication styles and resolve conflicts, and to sustain or improve family function in the cognitive, affective, and behavioral domains.
15999548|NCT02892994|Other|ultrasound|
15999549|NCT02892981|Other|cardiopulmonary exercise test,hypoxia and hypercapnia test|class I and IV Pulmonary hypertension patients in stable haemodynamic status and optimized medical therapy underwent cardiopulmonary test and hypoxia and hypercapnia tests to evaluate the chemoreceptor sensitivity
15999550|NCT02892968|Procedure|Fascia-Iliaca Block(FIB)|The target of the FIB is the potential space between the fascia iliaca and the iliacus muscle, at least 4 cm lateral to the Femoral artery. This is neither a drug nor a device.
15999551|NCT02892968|Procedure|Femoral Nerve Block(FNB)|The target of the FNB technique is the intersection of the fascia iliaca and the femoral nerve. This is neither a drug nor a device.
15999552|NCT02892955|Device|HeartMate 3 LVAS|Implantation of HeartMate 3 LVAD to evaluate safety and clinical performance of the HM3 LVAS for the treatment of advanced, refractory, left ventricular heart failure following completion of enrollment in the the MOMENTUM 3 IDE Study.
15999553|NCT02892942|Drug|Gonal-F®|225 to 450 IU/d; from day 2 of menstrual cycle onward
15999554|NCT02892942|Drug|Cetrotide®|0.25 mg/day, starting on day 6 of Gonal-F®.
15999555|NCT02892942|Drug|Cetrotide®|1.5 mg/day (6 ampoules of 0.25 mg), starting on day 1 (S1) of Gonal-F® treatment until dhCG
15999556|NCT02892929|Behavioral|Motivational interviewing|"The approach combines the principles of patient-centered care with strategies to motivate the change.
~Since the first appointment, Motivational Interviewing techniques will be used aiming to work the ambivalence that is to seek treatment and modify the unhealthy behavior. From the second encounter until the appointment of 120 days, the participants will be subjected to individual encounters in which the MI approach will be applied focusing on behavior change."
15999557|NCT02892929|Behavioral|Prescriptive Consultation|Prescriptive consultation is the Methodology usual consultation, in which the patient has little room to express themselves and the health professional who determines what and how the patient will hold the care of your health.
15999558|NCT02892916|Drug|Ketamine|A bolus of low intravenous dose (sub-anaesthetic) 0.5 mg/kg ketamine following induction of anaesthesia.
15999559|NCT02892916|Drug|Placebo|A bolus of an intravenous normal saline solution following induction of anaesthesia.
15999560|NCT02892903|Device|Routine Measurement of FFR|FFR measurement will be performed in all major vessels with normal (TIMI 3) flow. Occluded vessels and vessels with TIMI flow <3 will not be examined but will be 'awarded' an FFR value of 0.5
15999561|NCT02892890|Procedure|Muscle Magnetic Resonance Imaging (RMI) evaluation|
15999562|NCT02892890|Device|MRI|
15999563|NCT02892864|Other|Neuromuscular Retraining and Virtual therapy|Neuromuscular retraining is a problem solving approach to treatment using selective motor training to facilitate symmetrical movement and control undesired gross motor activity (synkinesis). Treatment consists to accomplish daily massages and facial exercises. Motivation on the part of the patient is a crucial element in the success of treatment
15999564|NCT02892864|Other|Oro-myo-functional classical rehabilitation|"Patients taken care in external consultation who receive oro-myo-functional rehabilitation through a virtual rehabilitation program targeted at the smile, in their place of living in virtual conditions.
~Patients taken care in consultation within the ENT service which provides oro-myo-functional classical rehabilitation."
15999565|NCT02892851|Device|Deep brain stimulation of the subthalamic nuclei (STN-DBS)|"3 phases :
~Parameter setting
~Cross-over double-bind (ON/OFF)
~Open Phase (ON)"
15999566|NCT02892838|Device|mobile bearing knee system for total knee arthroplasty|
15999567|NCT02892838|Device|fixed bearing total knee prosthesis|
15999568|NCT02892825|Other|Music|headphones with music
15999569|NCT02892825|Other|No Music|headphones without music
15999570|NCT02892812|Biological|Pneumococcal conjugate vaccine|
15999571|NCT02892799|Other|NICOM-Guided Diuresis|NICOM-based assessment of PLR-induced change in cardiac index
15999572|NCT02892799|Other|Standard of Care|
15999573|NCT02892786|Other|Circulating Tumor Cells|"Patients with stage III and IV head and neck squamous cell carcinoma undergoing surgery were enrolled in this study
~5 and 7.5 ml of peripheral venous blood will be taken before the surgery, just at the end of surgery and one week after surgery
~Analysis was performed by RT-PCR and the CellSearch™ method using immunomagnetic and fluorescence approaches.
~Patients will be followed every 3 months for two years."
15999574|NCT02892773|Device|Incentive Spirometry|"A respiratory therapist will provide instruction on Incentive Spirometry (I.S.) procedure performance before supervised therapy and monitoring begins.
~Study participants will be asked to take 10 deep breaths through the I.S.'s mouthpiece, followed by a 60 second pause.
~The 10-breath cycle will be repeated 3 times per therapy session.
~Each I.S. therapy session will last about 15 minutes, 3 times per day.
~Lung monitoring and deep breathing measurements will occur during a scheduled I.S. sessions on day 1, 3, and 5 after surgery."
15999708|NCT02891629|Device|EyeControl device|Use of device features including control of gestures, use of menus, activation of pre- defined modes and writing full sentences
15999709|NCT02891616|Drug|fludeoxyglucose F 18|
15999575|NCT02892773|Device|EzPAP® Positive Airway Pressure|"A respiratory therapist will provide instruction on EzPAP® procedure performance before supervised therapy and monitoring begins.
~Study participants will be asked to breathe normally through the EzPAP® device's mouthpiece for 10 breaths, followed by a 60 second pause.
~The 10-breath cycle will be repeated 3 times.
~Each EzPAP® therapy sessions will last about 15 minutes, 3 times per day.
~Lung monitoring will occur during a scheduled EzPAP® sessions on day 1, 3, and 5 after surgery."
15999576|NCT02892760|Device|C-Brace|C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking.
15999577|NCT02892747|Behavioral|Educational Program|
15999578|NCT02892734|Biological|Ipilimumab|Given IV
15999579|NCT02892734|Other|Laboratory Biomarker Analysis|Correlative studies
15999580|NCT02892734|Biological|Nivolumab|Given IV
15999581|NCT02892721|Other|Training with feedback|"One-day workshop of face to face training, comprising a mixture of theory and real-world CTC cases. Radiologists will complete four interpretation assessments lasting 2 to 3 hours: one set of 10 CTC cases immediately prior to training and a further test set of 10 immediately after, with tests repeated at 6 and 12 months (using different CTC cases for each set). Radiologists will be asked to identify colorectal cancer and polyps on the scans and complete an online answer form, including questions regarding diagnostic confidence, site of abnormality and management.
~The intervention group will receive online, confidential, individualised feedback after each test, which will include a case by case breakdown of their performance with explanatory answers and learning points."
15999582|NCT02892708|Procedure|Surgery|partial or complete resection followed by radiotherapy
15999583|NCT02892708|Radiation|radiotherapy|radiotherapy after a brain biopsy
15999584|NCT02892695|Biological|anti-CD19 CAR-NK cells|The allogeneic NK cells (NK-92 cell line for clinical use) are engineered to contain anti-CD19 attached to TCRzeta, CD28 and 4-1BB signaling domains. These modified cells are called chimeric antigen receptor NK cells with specificity for CD19.
15999585|NCT02892682|Other|BLOOD TEST|
15999586|NCT02892669|Other|non interventional study|non interventional study
15999587|NCT02892643|Procedure|Laparoscopic proximal gastrectomy|Laparoscopy proximal gastrectomy with esophago-jejunostomy, gastro-jejunostomy and jejuno-jejunostomy (double tract reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.
15999588|NCT02892643|Procedure|Laparoscopic total gastrectomy|Laparoscopic total gastrectomy with esophago-jejunostomy and jejuno-jejunostomy (Roux-en-Y reconstruction). Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.
15999589|NCT02892630|Other|No intervention|
15999590|NCT02892617|Other|Bacteriological analysis of disc|
15999591|NCT02892604|Device|insulin pump to inControl AP platform|Insulin from the pump is delivered according to the closed-loop algorithm fed by CGM data.
15999592|NCT02892591|Drug|Cannabis|vaporized plant material
15999593|NCT02892591|Drug|Oxycodone|oral capsule
15999594|NCT02892591|Drug|Placebo for Cannabis|vaporized placebo plant material
15999595|NCT02892591|Drug|Placebo for Oxycodone|oral placebo capsule
15999596|NCT02892578|Other|electrocardiogram|
15999597|NCT02892565|Other|Blood sample|
15999598|NCT02892552|Radiation|Cone Beam Computed Tomography (CBCT)|Patients had an additional Cone Beam Computed Tomography, after the usual MDCT
15999599|NCT02892552|Radiation|Multiple Detector Computed Tomography (MDCT)|Patients had a usual MDCT, before having an additional Cone Beam Computed Tomography
15999600|NCT02892539|Radiation|Coronary Angiography|
15999601|NCT02892526|Other|Abdominoplasty with exeresis of cutaneous tissue|
15999602|NCT02892526|Other|Collection of cutaneous tissue|
15999603|NCT02892513|Device|Percutaneous auricular neurostimulation|The Bridge device (manufactured by Key Electronics [Jeffersonville, IN, USA] and distributed by Innovative Health Solutions [Versailles, IN, USA]) provides continual neurostimulation for five days with alternating current.
15999604|NCT02892513|Device|Sham percutaneous auricular neurostimulation|Identical in appearance to active, device, but no stimulation will be given.
15999605|NCT02892500|Drug|bupivacaine hydrochloride and betamethasone sodium phosphate|5ml of 0.25% bupivacaine hydrochloride and 2 ml of 3mg/ml betamethasone sodium phosphate one injection into the inferior tibiofibular ligament
15999606|NCT02892500|Drug|bupivacaine hydrochloride|5ml of bupivacaine hydrochloride into the tibiofibular ligament
15999607|NCT02892487|Other|Swallowing therapy|Patients will undergo active swallowing therapy with a speech and language therapist (twice a week) combined to a detailed program of swallowing auto-exercises (twice a day) from start of radiotherapy to one month after the end.
15999608|NCT02892474|Procedure|Hybrid Coronary Revascularization (HCR)|Hybrid coronary revascularization (HCR) is a combination of surgery and catheter procedures to open up clogged heart arteries. HCR is the intentional combination of coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI). The HCR strategy combines grafting of the left anterior descending artery (LAD) coronary artery using the left internal mammary artery (LIMA) with PCI of non-LAD coronary stenoses. Drug-eluting stents are substituted for saphenous vein grafts (SVG) for non-LAD coronary targets, and the surgical LIMA to LAD bypass is performed, ideally through a minimally invasive, limited access, sternal-sparing approach.
15999609|NCT02892474|Procedure|Coronary Artery Bypass Grafting (CABG)|Coronary artery bypass grafting (CABG) is a surgery to create a new path for blood flow to the heart. A healthy section of vein or artery from elsewhere in the patient's body will be attached to the coronary artery just above and below the area of concern, to create a way for blood to bypass the blocked part of the coronary artery.
15999610|NCT02892461|Procedure|Umbilical cord milking|As same as that in arm descriptions.
15999611|NCT02892448|Other|Cardiac magnetic resonance imaging (CMR)|Cardiac MRI is used to assess cardiac function in patients at risk of cardiotoxicity. In addition, Cardiac MRI enables imaging of inflammation, and fibrosis in the heart which may provide more specific information about the mechanism of injury in patients with high ion blood levels. Patients in all three groups (Unilateral hip resurfacing, bilateral hip resurfacing, and non-metal on metal total hip arthroplasty) will undergo a Cardiac MRI.
15999612|NCT02892435|Device|incisional negative pressure wound therapy|positioning incisional negative pressure therapy over closed wound.
15999613|NCT02892435|Device|conventional dressing|positioning conventional dressing
15999614|NCT02892422|Drug|Lu AF35700|"Flexible-dose of Lu AF35700, 10 or 20 mg/day, tablets, orally.
~From Day 8, the daily dose can be increased to 20mg. Thereafter, the daily dose can be adjusted (decreased to 10mg or following a decrease, increased to 20mg/day)
~Patients who completed the 16159A study, only, can be switched to a weekly 70 mg Lu AF35700 dosing regimen (tablets, orally, once weekly) after 8 weeks in this study"
15999615|NCT02892409|Drug|Clarithromycin|Clarithromycin tablets
15999616|NCT02892409|Drug|Amoxicillin|Amoxicillin capsules
15999617|NCT02892409|Drug|Tripotassium bismuth dicitrate|Tripotassium bismuth dicitrate tablets
15999618|NCT02892409|Drug|Lansoprazole|Lansoprazole capsules
15999619|NCT02892409|Drug|TAK-438|TAK-438 tablets
15999620|NCT02892370|Drug|SHR0302|SHR0302 tablets (10 mg)
15999621|NCT02892357|Drug|Treatment group|Jianpi Qinghua granules:twice a day,1 bag a time;10mg omeprazole and 10mg sham ,once a day,all for 4 weeks.
15999622|NCT02892357|Drug|Control group|sham Jianpi Qinghua granules:twice a day,1 bag a time; 20mg omeprazole once a day ,all for 4 weeks.
15999623|NCT02892344|Drug|QMF149 150/80 μg|QMF149 150/80 μg o.d via Concept1
15999624|NCT02892344|Drug|MF 200 μg|MF 200 μg o.d. via Twisthaler®
15999625|NCT02892331|Behavioral|Moderate intensity exercise training (MOD-INT)|Participants in the MOD-INT group will exercise at the heart rate associated with 45-55% VO2 max. The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)
15999626|NCT02892331|Behavioral|High Intensity exercise training (HI-INT)|Participants in the HI-INT group will exercise at the heart rate associated with 70-80% VO2 max (heart rate ranges will be updated at mid-intervention CRF assessment). The exercise volume will be 600 MET-minutes per week, which is consistent with current public health guidelines (500-1,000 MET-minutes)3
15999627|NCT02892318|Drug|Atezolizumab|Atezolizumab 840 mg administered by IV infusion on Days 8 and 22 of each 28-day cycle.
15999628|NCT02892318|Drug|Guadecitabine|Guadecitabine 60 mg/m^2 SC on Days 1-5 of every 28-day cycle.
15999629|NCT02892305|Procedure|Hepatic Resection or Ablation with Pancreaticoduodenectomy|"Patients will undergo pancreaticoduodenectomy, or the Whipple procedure, which involves removal of the head of the pancreas, the duodenum, and a portion of the stomach, as well as the gallbladder and a portion of the bile duct.
~The patient will also undergo a Hepatectomy, the surgical resection or removal of all or part of the liver or Microwave Ablation (MWA) if determined by the surgeon to be the best course of care."
15999630|NCT02892279|Other|Diesel exhaust exposure|Evaluation of sympathetic nervous system activity as assessed by microneurography recording during an acute exposure to dilute diesel exhaust via mask.
15999631|NCT02892266|Other|Assessment of adherence, mental health, behavioral, quality of life and biological constructs|
15999632|NCT02892253|Device|Near Infrared Camera (NIR)|Surgical field is examined with NIR, during a few minutes (<5') with room lights switched off, to avoid parasite lights, then open thyroidectomy is resumed conventionally. Real-time images, evocative of autofluorescent parathyroids, are checked visually. NIR consists of a 750 nm class 1 laser excitation, with a power <20mW/cm2 (5 times less than the limit of 100mw/cm2, fixed by the international standard IEC 60601-2-41). It is provided by the Fluobeam® camera, which is inserted into a sterile cover and hold at a 15-20 cm distance from the patient. The system has an FDA 510(k) authorization for clinical use in parathyroid surgery and a European Community certification (Class 2A device).
15999633|NCT02892240|Other|No intervention. Observational study|
15999634|NCT02892227|Procedure|Transmitral flow estimation|Estimation of the transmitral flow of the inferior vena cava and its variations
15999635|NCT02892214|Procedure|Pelvic floor physical therapy|
15999636|NCT02892214|Drug|estriol cream (ovestin)|
15999637|NCT02892214|Procedure|Low-level-laser therapy|
15999638|NCT02892201|Drug|Pembrolizumab|a constant dose of 200 mg every three weeks, for four cycles.
15999639|NCT02892175|Procedure|Advance Directives on End of Life|after information transmitted orally by the doctor (Dr P.Priollet) and agreement of the patient to participate, patients will be interviewed (Questionary) and data collected during visits to consultations City office of Dr. Priollet by Dr. Priollet assisted by Mrs. Helena Sanson (internal medicine), anonymized and handled within the vascular medicine department of Dr. Priollet to GHPSJ.
15999640|NCT02892162|Procedure|Additional LAAW linear ablation|Additional linear ablation on LAAW using ThermoCool SmartTouch ablation catheter.
15999641|NCT02892149|Drug|vadadustat|Oral tablet
15999642|NCT02892149|Drug|darbepoetin alfa|subcutaneous/intravenous
15999643|NCT02892123|Drug|ZW25 (Zanidatamab)|ZW25 administered IV once weekly, once every 2 weeks, or once every 3 weeks. Part 1: in multiple increasing doses; Part 2: ZW25 given at the MTD, OBD, or an RD identified in Part 1; Part 3: ZW25 given at the MTD, OBD, or an RD combined with one of the following selected drug combination:
15999644|NCT02892123|Drug|Paclitaxel|Combination therapy with ZW25 - Part 3 Treatment Groups 1 and 4
15999645|NCT02892123|Drug|Capecitabine|Combination therapy with ZW25 - Part 3 Treatment Groups 2 and 5
15999646|NCT02892123|Drug|Vinorelbine|Combination therapy with ZW25 - Part 3 Treatment Groups 3 and 6
15999647|NCT02892123|Drug|Tucatinib|Combination therapy with ZW25 and Capecitabine - Part 3 Treatment Group 7
15999648|NCT02892123|Drug|Tucatinib|Combination therapy with ZW25 - Part 3 Treatment Group 8 (may be opened if recommended by the Safety Monitoring Committee and/or the sponsor)
15999649|NCT02892110|Drug|Varenicline|2 mg daily
15999650|NCT02892110|Drug|Placebo|2 mg daily
15999651|NCT02892097|Device|tDCS|tDCS is a form of noninvasive brain stimulation. Electrodes are placed on the scalp (parietal or primary motor cortex) and deliver a low level of direct current (2mA). tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand.
15999652|NCT02892097|Device|sham tDCS|Sham tDCS will be delivered for 30 minutes in conjunction with repetitive task-specific practice for the arm/hand.
15999653|NCT02892097|Behavioral|Repetitive task-specific practice (RTP)|Participants will practice using their paretic arm/hand to complete functional movements during each (3) 30 minute training session.
15999654|NCT02892084|Device|tDCS|Constant non-invasive, low intensity, direct electrical current utilized to stimulate specific areas of the brain. Evaluating immediate effects of anodal/cathodal stimulation during 20 minutes of treadmill walking.
15999710|NCT02891616|Device|Positron emission tomography-computed tomography|
15999655|NCT02892084|Device|Sham tDCS|"Per published protocols, tDCS will be administered for 30 secs allowing for sensory adaptation to occur and then turned off, so that the remaining sham stimulation will include zero current. Evaluating immediate effects during 20 minutes walking on a treadmill."
15999656|NCT02892071|Drug|22% TCA peel|One of the three facial areas (based on random assignment- forehead, left cheek, right cheek) will be treated with one treatment with a 22% TCA Blue Peel, to achieve a level 2 frost (medium depth peel). Each treatment will take about 20 minutes. A 22% TCA concentration will be created by combining 5.5 mL of 30% TCA (from a purchased commercial bottle) with 2mL of blue dye (commercial), immediately before application.
15999657|NCT02892071|Device|CO2 laser|One of the three facial areas (based on random assignment- forehead, left cheek, right cheek) will receive one treatment with one pass of the fractionated ablative 10,600 nm CO2 (CO2RE Laser, Syneron) at Core 70 mJ, Ring 50mJ, 40% coverage, 1 pass, 8 mm square pattern. Each treatment will take about 20 minutes.
15999658|NCT02892071|Device|Qs-NdYag laser|Long pulsed Q-switched Nd:Yag laser. One of the three facial areas (based on random assignment- forehead, left cheek, right cheek) will be treated with Q-switched (Qs) 1064 Nd:YAG (Medlite C3; 6 mm spot size, collimated homogenous flat- top beam profile, energy fluence 2.0 J/cm2, 5Hz), with 5% coverage and 2 passes (or until mild erythema detected). Treatments will be performed at 2-week intervals for six sessions. Each treatment will take about 20 minutes.
15999659|NCT02892045|Device|MMG|neuromuscular monitoring device
15999660|NCT02892032|Behavioral|Attention Modification Training|Subjects are taught to disengage attention from a certain stimuli
15999661|NCT02892032|Behavioral|No Attention Modification Training|Subjects are exposed to two stimuli, but attention is not manipulated in any way
15999662|NCT02892019|Drug|Indacaterol acetate 75 μg|Indacaterol acetate 75 μg o.d. delivered via Concept1 inhaler
15999663|NCT02892019|Drug|Indacaterol acetate 150 μg|Indacaterol acetate 150 μg o.d. delivered via Concept1 inhaler
15999664|NCT02892006|Behavioral|Improvisational Comedy|6 week curriculum in improvisational comedy. Each class meets for 1.5 hours for 6 consecutive weeks.
15999665|NCT02891993|Other|IMPROVED|"The electronic symptom monitoring intervention, Improving Management of Patient-Reported Outcomes Via Electronic Data (IMPROVED), consists of patients self-reporting their symptoms each day using a tablet computer. At morning rounds each day, the clinical team will view reports detailing their patients' symptom burden."
15999666|NCT02891993|Other|Usual Care|Participants receiving usual care will also self-report their symptoms each day using tablet computers. However, these patients' clinicians will not receive their symptom reports. Patients randomized to usual care will report their symptoms to their clinicians as they usually would, at their own discretion.
15999667|NCT02891980|Biological|Ad26 Zaire Ebola Vaccine|A recombinant adenovirus vector comprising a polynucleotide encoding a filovirus antigenic protein, wherein the recombinant adenovirus vector comprises an adenovirus 26 capsid protein.
15999668|NCT02891980|Biological|MVA Multi-Filo Ebola Vaccine|A multivalent MVA-BN Filovirus vaccine, designed to protect against Ebola Zaire, Ebola Sudan and Marburg virus.
15999669|NCT02891967|Other|bulk fill composite|cavities will be incrementally layered with resin composite and each increment will be cured as directed by the manufacturer with the light curing unit (XL 3000; 3M/eSPe), with an energy higher than 450 mW/cm² (±50 mw/cm²)
15999670|NCT02891967|Other|Nano resin composite (K Z350 xt)|cavities will be restored by bulk fill composite (3M ESPE) as one increment then will be cured as directed by the manufacturer with the light curing unit.
15999671|NCT02891954|Drug|Canagliflozin|Healthy volunteers will receive canagliflozin (300 mg per day) in the morning for five days.
15999672|NCT02891928|Device|Rocker sole shoes|Measure of walk testing Measure of standing position
15999673|NCT02891928|Device|Normal shoes|Measure of walk testing Measure of standing position
15999674|NCT02891915|Drug|Amoxicillin|Amoxicillin is an aminopenicillin antibiotic
15999675|NCT02891915|Drug|Amoxicillin-clavulanate|A fixed-ratio combination of amoxicillin trihydrate, an aminopenicillin, and potassium clavulanate, a beta-lactamase inhibitor, used to treat a broad-spectrum of bacterial infections, especially resistant strains.
15999676|NCT02891915|Drug|Cefdinir|Cefdinir is a cephalosporin antibiotic used to treat bacterial infections in many different parts of the body.
15999677|NCT02891915|Other|Placebo|Placebo
15999678|NCT02891902|Other|hygienist response|The daily presence of a public health nurse in the intensive care unit would implement such a strategy for prevention of infections and reduce the incidence of bloodstream infections acquired in intensive care.
15999679|NCT02891863|Device|LEVER Acute Study System|The LEVER Acute Study System is an acute pacing and shock delivery system intended for investigational use only. The LEVER Acute Study System is intended for acute conversion testing of monomorphic ventricular tachycardia by one of three different VT conversion methods.
15999680|NCT02891850|Drug|Riociguat (Adempas, BAY63-2521)|Film-coated tablets will be used in this study at a dosage of 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg. Tablets will be administered orally.The starting dose is 1 mg TID; the intervals between drug intakes should be 6 to 8 hours. The dosage should be increased by 0.5 mg increments in 2 week intervals to 1.5 mg, 2.0 mg, and 2.5 mg TID (maximal total daily dose).
15999681|NCT02891850|Drug|Sildenafil|Patients randomized to the control arm will continue to receive stable doses of tadalafil (daily dose 20 to 40 mg) or sildenafil (daily dose at least 60 mg) as well as other supportive treatments at the discretion of the investigator.
15999682|NCT02891850|Drug|Tadalafil|Patients randomized to the control arm will continue to receive stable doses of tadalafil (daily dose 20 to 40 mg) or sildenafil (daily dose at least 60 mg) as well as other supportive treatments at the discretion of the investigator.
15999683|NCT02891837|Drug|L-citrulline|"Bolus of 150 mg/kg at the initiation of cardiopulmonary bypass, but after removal of any crystalloid base;
~Addition of study medication at a concentration of 200 μmol/L given as a bolus during bypass. This may be administered as a one-time bolus or multiple administrations to compensate for fluids containing L-citrulline that may be removed from the patient during the course of the operation and thus to maintain the concentration of 200 μmol/L;
~Bolus of 20 mg/kg 30 minutes after decannulation from cardiopulmonary bypass;
~9 mg/kg/hr continuous infusion for up to 48 hours."
15999711|NCT02891616|Drug|18F-fluorothymidine|
15999712|NCT02891616|Device|Positron emission tomography-magnetic resonance imaging|
15999790|NCT02890992|Drug|statins|Pharmaceutical form: tablet Route of administration: oral
15999684|NCT02891837|Other|Placebo|"Bolus of 150 mg/kg at the initiation of cardiopulmonary bypass;
~Addition of placebo matched for volume given as a bolus during bypass. This may be administered as a one-time bolus or multiple administrations during bypass;
~Bolus of 20 mg/kg 30 minutes after decannulation from cardiopulmonary bypass;
~9 mg/kg/hr continuous infusion for up to 48 hours."
15999685|NCT02891824|Drug|atezolizumab + avastin + platinum-based chemotherapy|"atezolizumab will be administrated by intraveinous route at dose of 1200 mg or 800 mg during the induction period and will be continued in maintenance period at a dose of 1200mg until progression
~avastin will be administrated by intraveinous route at dose of 15mg/kg or 10 mg/kg during the induction period and will be continued in maintenance period of at a dose of 15mg/kg until progression
~platinum-based chemotherapy (Carboplatin combined with gemcitabine or paclitaxel or pegylated liposomal doxorubicin) will be administrated by intraveinous route at different doses during the induction period x 6 cycles"
15999686|NCT02891824|Drug|placebo + avastin + platinum-based chemotherapy|"placebo will be administrated by intraveinous route at dose of 1200 mg or 800 mg during the induction period and will be continued in maintenance period at a dose of 1200mg until progression
~avastin will be administrated by intraveinous route at dose of 15mg/kg or 10 mg/kg during the induction period and will be continued in maintenance period of at a dose of 15mg/kg until progression
~platinum-based chemotherapy (Carboplatin combined with gemcitabine or paclitaxel or pegylated liposomal doxorubicin) will be administrated by intraveinous route at different doses during the induction period x 6 cycles"
15999687|NCT02891811|Drug|Carfilzomib|Induction treatment: Cycle 1 day 1+2: 20 mg/m2; days 8,9, 15 and 16: 27 mg/m2; Cycle 2: 27 mg/m2 on days 1,2,8,9,15 and 16; Cycle 3-9: 56 mg/m2 on days 1, 8 and 15; IV duration: 30-60 minutes; Maintenance treatment with carfilzomib (last tolerated dose on day 1 and 15 (± 7 days) of each cycle)
15999688|NCT02891811|Drug|Thalidomide|100mg orally on days 1-28 in patients <75 years of age at Cycle 1; 50mg p.o. on days 1-28 in patients ≥ 75 years of age at Cycle 1
15999689|NCT02891811|Drug|Lenalidomide|25mg p.o. on days 1-21 of each cycle
15999690|NCT02891811|Drug|Dexamethasone|40mg p.o. on days 1, 8, 15,22 (± 1 day ) in patients <75 years of age at Cycle 1; 20mg p.o. on days 1, 8, 15, 22 (± 1 day) in patients ≥ 75 years of age at Cycle 1, given 4 hours-30 min prior to carfilzomib
15999691|NCT02891798|Drug|Bupivacaine + CBD (clonidine, buprenorphine, dexamethasone)|Nerve blocks before surgery of L2-L4 and L4-S3 for Knee replacements Nerve blocks before surgery of L2-L4 for hip replacements
15999692|NCT02891798|Drug|Bupivacaine Only (control arm)|Nerve blocks before surgery of L2-L4 and L4-S3 for Knee replacements Nerve blocks before surgery of L2-L4 for hip replacements
15999693|NCT02891785|Behavioral|ANtiPain|After the implementation of ANtiPain, patients will receive cancer pain self-management support by trained staff nurses who follow the ANtiPain protocol. ANtiPain is based on 3 key strategies: Provision of information, skill building and nurse coaching. It consists of an in-hospital one-to-one session before discharge and a telephone follow up according to a clinical algorithm based on pain intensity, patient satisfaction with pain management and patient adherence. Patients will be given a booklet with corresponding info. The implementation process will include training of designated staff nurses, coaching activities based on case discussions on the ward, as well as measures to ensure sustainability of the implementation (e.g., training of ward managers and clinical nurse specialists).
15999694|NCT02891772|Procedure|ultrasonographic measurement of corrected flow time(FTc) in carotid artery|Corrected carotid artery flow time is measured using 10-5 MHz linear probe on a portable ultrasound machine. On the two-dimensional image, the optimal image of the long-axis view is obtained at the left common carotid artery. The sample volume is placed on the center of the lumen, 2 cm proximal to the bulb, and a pulsed wave Doppler examination was performed. Then, cardiac cycle time and carotid flow time is measured. Carotid flow time is measured between the upstroke of the flow tracing and the dicrotic notch, and it is corrected for pulse rate by dividing flow time by the square root of the cardiac cycle time to calculate corrected carotid artery flow time (flow time/√cycle time). The blood pressure was taken before anesthetic induction and every two minutes after anesthetic induction till ten minutes after endotracheal intubation.
15999695|NCT02891759|Other|Alloderm RTU|-Most commonly used acellular dermal matrices
15999696|NCT02891759|Other|Cortiva 1mm Allograft Dermis|-Tutoplast processed dermis
15999697|NCT02891759|Procedure|Skin or nipple-sparing mastectomy|-Standard of care
15999698|NCT02891759|Other|Breast Q|"15 questions
~10 questions in Part A asking how has the patient been feeling in past 24 hours, answers range from 0-10 with 0=none of the time and 10=all of the time
~Part B has 5 questions asking patient if she has had any of the following in the last 24 hours, answers ranging from 0-10 with 0=none of the time and 10=all of the time"
15999699|NCT02891759|Procedure|Surgery|"To address the tissue expander
~Standard of care"
15999700|NCT02891746|Other|non invasive sampling|
15999701|NCT02891720|Device|Proteus Sensor System|The Proteus Sensor System (PSS) intervention includes 12 weeks of daily FTC/TDF with a weekly text messages transmitted to participants with estimated HIV risk reduction based upon the DBS algorithm.
15999702|NCT02891707|Device|Rehabilitative Lower-limb Orthopedic Accommodating-feedback Device (ReLOAD)|"The study will use a novel piece of technology, the ReLOAD, which is a data collector system that uses instrumented insoles, custom, miniature (1x1) microcontroller with accelerometer, gyroscopes, and geomagnetic sensors connected to a Bluetooth transceiver to collect and transmit gait kinematic data to mobile devices, such as an iPad and iPod. When a person walks or performs a specific activity, the ReLOAD system captures the movement, which can then be stored locally within the mobile device and/or encrypted and sent to a secured central server. This allows the patient or provider to access clinically relevant biomechanical data to help guide rehabilitation."
15999703|NCT02891694|Other|in vitro immuno-histo-chemical analysis of corneal epithelium|
15999704|NCT02891681|Device|Optical Tomography Using Near Infrared Diffused Light Assisted with Ultrasound|
15999705|NCT02891668|Drug|Levothyroxine treatment|Eltroxin/Euthyrox is part of the normal treatment for hypothyroidism, and the patient is treated equally, whether he/she participates or not.
15999706|NCT02891655|Other|immuno-histo-chemical analysis|in vitro immuno-histo-chemical analysis of corneal epithelium
15999707|NCT02891642|Device|Immunomagnetic Detection|Immunomagnetic separation will be assessed through analysis of the percentage of positive samples identified compared to cytological techniques.
15999748|NCT02891382|Behavioral|Companion Support|Patient has a companion/team support partner to support achieving goals.
15999713|NCT02891603|Drug|Pacritinib|Pacritinib Dose and Schedule: 200 mg twice a day (BID) orally from day 0 until day +100. PAC will be tapered to 50% of the total dose at day +70, then 25% of total dose at day +84, then stop at day +100 (+/- 7 days).
15999714|NCT02891603|Drug|Sirolimus|In addition to the study drug, pacritinib, sirolimus and tacrolimus (SIR/TAC) will be administered and dosed according to Moffitt Cancer Center, Department of Blood and Marrow Transplantation standard practice. Attending physician discretion is permitted with regard to timing, rapidity, and completion of SIR/TAC taper. SIR/TAC levels will be monitored according to program standard operating procedures. Dose modifications of SIR/TAC for concurrent use of CYP3A4 inhibitors or inducers will be based on program standard operating procedures.
15999715|NCT02891603|Drug|Tacrolimus|In addition to the study drug, pacritinib, sirolimus and tacrolimus (SIR/TAC) will be administered and dosed according to Moffitt Cancer Center, Department of Blood and Marrow Transplantation standard practice. Attending physician discretion is permitted with regard to timing, rapidity, and completion of SIR/TAC taper. SIR/TAC levels will be monitored according to program standard operating procedures. Dose modifications of SIR/TAC for concurrent use of CYP3A4 inhibitors or inducers will be based on program standard operating procedures.
15999716|NCT02891590|Drug|DTRMWXHS-12|
15999717|NCT02891577|Procedure|Ultrasonography|At the time of ICU admission, among critically ill patients with shock, the investigators will measure the diameter of the common femoral vein and that of the inferior vena cava by ultrasonography.
15999718|NCT02891564|Behavioral|Band Together|a mobile 3D video game that has been shown to reduce older adults' susceptibility to interference by augmenting sustained attention and working memory abilities (e.g. cognitive control) through targeted adaptive algorithms. This game is analogous to Project: EVO.
15999719|NCT02891564|Other|Control Mobile 3D video game|expectancy-matched control game
15999720|NCT02891538|Drug|Epigallocatechin gallate (EGCG)|Teavigo™ is a natural, caffeine-free, highly purified and refined green tea extract providing 94% epigallocatechin gallate (EGCG).*
15999721|NCT02891525|Dietary Supplement|50g glucose|
15999722|NCT02891525|Dietary Supplement|25g fructose|
15999723|NCT02891525|Dietary Supplement|220mg acesulfame-K|
15999724|NCT02891525|Dietary Supplement|250mL tap water|
15999725|NCT02891512|Other|ELF|Very low frequency magnetic fields (ELF) at intensity of 100 mT and a frequency of 1-80 Hz. Protocol (antiedema-antinflammatory): 12 sessions, 3 times a week for 4 consecutive weeks, each session lasted 30 minutes.
15999726|NCT02891512|Other|Xinepa®|2 tablets of Xinepa daily (morning and evening) for 1 month.
15999727|NCT02891512|Other|Placebo Xinepa®|2 tablets of Xinepa placebo daily (morning and evening) for 1 month.
15999728|NCT02891499|Procedure|Low-level laser therapy|"Immediate post-operative period (implantation day) Red emission (660 nm) Energy density: 4 J/cm2 Power: 0.1W Irradiation area: 0,5 cm2 One application, 10 seconds of non-contact irradiation (01 point at the area surrounding the miniscrew) at a distance of 15,5 mm.
~Mediate post-operative period (after implantation day) Infrared emission (808 nm) Energy density: 8 J/cm2 Power: 0.1W Irradiation area: 0,5 cm2 6 applications every 48 hours after the day of implantation, 20 seconds of non-contact irradiation (01 point on the area surrounding the miniscrew) at a distance of 15,5 mm."
15999729|NCT02891499|Procedure|Mediate force application|Mediate force application protocol: orthodontic force application (150 gF) 4 weeks after the day of the implantation.
15999730|NCT02891486|Procedure|Spinal surgery|Elective spinal surgery performed
15999731|NCT02891473|Other|Mézières Method|10 sessions of rehabilitative treatment according to the Mézières Method, 2 sessions per week for 5 weeks, each lasting 1 hour.
15999732|NCT02891473|Other|Home based exercise program|1 single training session lasting 1 hour for the explication of the rehabilitation program that the patient has to perform independently at home followed by 2 sessions of home based exercises per week for 5 weeks, each lasting 1 hour.
15999733|NCT02891460|Device|40 mg MMC in 40 mL TC-3.|A reverse thermal biodegradable gel (TC-3) (low viscosity at 5°C gel appearance at body temperature) for drug retention in the urinary bladder.
15999734|NCT02891460|Device|80 mg MMC in 40 mL TC-3.|A reverse thermal biodegradable gel (TC-3) (low viscosity at 5°C gel appearance at body temperature) for drug retention in the urinary bladder.
15999735|NCT02891447|Drug|Cisplatin|Given intraperitoneally
15999736|NCT02891447|Drug|Hyperthermic Intraperitoneal Chemotherapy|Undergo HIPEC
15999737|NCT02891447|Drug|Mitomycin|Given intraperitoneally
15999738|NCT02891434|Device|Acquisition on TouchScreen|Participants performed acquisition and retention on TouchScreen, transfer 1 on Kinect and transfer 2 on LeapMotion.
15999739|NCT02891434|Device|Acquisition on Kinect|Participants performed acquisition and retention on Kinect, transfer 1 on TouchScreen and transfer 2 on LeapMotion.
15999740|NCT02891434|Device|Acquisition on LeapMotion|Participants performed acquisition and retention on LeapMotion, transfer 1 on TouchScreen and transfer 2 on Kinect.
15999741|NCT02891421|Behavioral|Therapeutic Horseback Riding|Veterans were matched to a horse for best fit and the same horse was ridden each week. The warm-up exercises involved various repeated physical movements while the horse was walking or standing steady, such as head rotations, lifting arms, rotating ankles, flexing toes. The exercises began with riding at a walk during the early weeks, learning reining skills and riding positions, and progressed to light trotting. Veteran participants were able to build on skill sets related to grooming, tacking, mounting, and riding that were introduced in prior weeks. Skill progression was based on individual abilities and safety as determined by certified riding instructor and occupational therapist.
15999742|NCT02891421|Other|Standard Care|Standard Care: Participants received standard care
15999743|NCT02891408|Drug|Firsocostat|Capsule(s) administered orally on Day 1
15999744|NCT02891408|Drug|Fenofibrate|Tablet administered orally on Day 1
15999745|NCT02891395|Drug|Imatinib Mesylate and Nilotinib|"For patients under Imatinib Mesylate: the total length of follow up period for those patients will be for 52 weeks following IM treatment, with a follow up at weeks IM4, IM8, IM12, IM26, IM38 and IM52.
~For patients requiring a salvage phase: after the switch for nilotinib, the total length of follow up period for this phase will be for 52 weeks following nilotinib treatment, with a follow up at weeks nilo4, nilo8, nilo12, nilo26, nilo38 and nilo52."
15999746|NCT02891382|Behavioral|Diabetes education|Participants interact with a diabetes educator (DE), every two weeks.
15999747|NCT02891382|Behavioral|Goal setting|Goals for weight loss and change in levels of HbA1c
15999752|NCT02891356|Device|DEXA|The Dual Energy X-ray Absorptiometry (DEXA) is a third generation multi-captor DEXA device that allow short duration measurements. It measures Bone Mineral Density (BMD) at the spine and the femoral neck
15999753|NCT02891343|Other|2-hour period of hypoxia|During this period, the FiO2 will be set on 21% (normoxia condition). A filter will be put between the mask and the tubes connecting it to the machine generating hypoxia (equipment reference = Altitrainer NP190). On that filter a gas analyser will monitor the FiO2 and a capnography monitor (Capnostream 20, ORIDION) will also be installed.
15999754|NCT02891330|Behavioral|Dietary and nutritional recommendations conducted by a nurse|Supplementary dietary and nutritional education
15999755|NCT02891304|Other|Quarterly Feedback|Learning curves received quarterly vs. annually
15999756|NCT02891278|Drug|Sertraline|"Sertraline is a selective serotonin reuptake inhibitor (SSRI) that is FDA approved to treat major depressive disorder, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder, premenstrual dysphoric disorder, and social anxiety disorder.
~Sertraline will be administered orally twice a day starting on day -3. Sertraline will be administered at one of 4 pre-defined dose levels in the following dose-escalation: 50 mg daily, 50 mg twice a day, 50 mg every morning (QAM) and 100 mg every evening (QPM), 100 mg twice a day. 100 mg QAM and 150 mg QPM."
15999757|NCT02891278|Drug|Cytosine arabinoside|"Cytarabine is a cytotoxic chemotherapy approved for use in acute myeloid leukemia, acute lymphoblastic leukemia, and chronic myelogenous leukemia. It is also approved to prevent and treat meningeal leukemia. Cytarabine kills cells in S-phase through inhibition of DNA polymerase, as well as by halting DNA synthesis after its incorporation into DNA.
~Cytosine arabinoside (Ara-C) will be administered as a 72 hour intravenous continuous infusion (IVCI) beginning Day 1 of therapy and again beginning Day 10 of therapy. The total dose of ara-C for each 72 hour period is 2 gm/m2 (0.667 gm/m2/24 hours)."
15999758|NCT02891278|Procedure|allogeneic stem cell transplantation|Allogeneic stem cell transplantation involves transferring the stem cells from a healthy person (the donor) to a patient after high-intensity chemotherapy or radiation.
15999759|NCT02891265|Behavioral|Smoking cessation patch|To compare the smoking cessation outcome in patients with fractures with or without the help of smoking cessation patches.
15999760|NCT02891252|Procedure|outpatient procedure|
15999761|NCT02891239|Device|PicoWay|solid state laser capable of delivering energy at wavelengths of 1064 nm or 532 nm or wavelength of 785 nm that was added to the system
15999762|NCT02891226|Drug|Mirikizumab|
15999763|NCT02891226|Drug|Placebo|
15999764|NCT02891200|Other|Peer support program|The Peer Support Program offers education and support to participants by especially trained 'peer mentors' with oversight from a social worker.
15999765|NCT02891200|Other|HCP support|Healthcare professional (HCP) support will be provided by a trained respiratory therapist who will provide COPD self-management education and support via an in-person session and written materials .
15999766|NCT02891187|Behavioral|Telephone follow-up|Patients will be called for postoperative care at 1-2 weeks, 6 weeks, and 3 months
15999767|NCT02891187|Behavioral|Outpatient Clinic Visits|Patients will return to the clinic at 1-2 weeks, 6 weeks, and 3 months
15999768|NCT02891174|Drug|Ibuprofen|At the time of delivery, eligibility will be reviewed. If the participant remains eligible, she will be randomized by the study pharmacy to begin post-partum analgesic therapy with ibuprofen followed by acetaminophen.
15999769|NCT02891174|Drug|Acetaminophen|At the time of delivery, eligibility will be reviewed. If the participant remains eligible, she will be randomized by the study pharmacy to begin post-partum analgesic therapy with acetaminophen followed by ibuprofen.
15999770|NCT02891161|Drug|durvalumab|1500 mg Q4 weekly
15999771|NCT02891161|Radiation|Radiation Therapy|64.8 Gy, 36 daily fractions on weekdays over about 7 weeks
15999772|NCT02891148|Drug|BI 690517|
15999773|NCT02891135|Other|SLATE|Algorithm for collecting information required to determine if patient is eligible for immediate (same-day/same-visit) initiation of antiretroviral medications.
15999774|NCT02891109|Biological|Biological tests|From the blood: B and T cells extraction then co-culture B and T cells and characterization of lymphocytes by flow cytometry
15999775|NCT02891096|Procedure|inspiratory muscle strength|"Measurements:
~in- and expiratory muscle strength (5min)
~lung function (FVC, FEV1, PEF, PCF) (10 min)
~Questionnaires:
~ISCoS core data-set
~ISCoS pulmonary function data sets
~ISCoS quality of life questionnaire
~questionnaire on individual respiratory muscle training, regular physical exercise and therapies
~individual medication/vaccination and other medical complications will be assessed from patient's medical records
~All measurements will be performed at each of the 4 measurement time-points (up to 4 times during inpatient rehabilitation) and last about 40 min per patient and measurement time-point in total (time with patient)."
15999776|NCT02891083|Drug|Adjuvant chemotherapy (Paclitaxel and Cisplatin)|Adjuvant chemotherapy group: three cycles: (Paclitaxel: 175mg/m2 ivgtt, 3h, d1 4week × 3 and cisplatin: 75mg/m2 ivgtt, d1 4 week × 3)
15999777|NCT02891083|Radiation|Adjuvant radiotherapy|"Target: the upper mediastinum and bilateral supraclavicular region (Upper bound: thyrocricoid, lower bound: carina of 3cm)
~Dose: 50Gy
~Technology: strong tone
~Segmentation: conventional segmentation 2Gy/d"
15999778|NCT02891083|Other|Control group (Surgery alone)|
15999779|NCT02891070|Drug|FS VH S/D 500 s-apr|
15999780|NCT02891070|Device|DuraSeal Dural Sealant|
15999781|NCT02891057|Drug|BAY987517|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z44-036)
15999782|NCT02891044|Drug|BAY987517|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z44-040)
15999783|NCT02891031|Drug|Rhus (Somagh)|500 mg twice daily after meal for 6 weeks
15999784|NCT02891031|Drug|Placebo|500 mg twice daily after meal for 6 weeks
15999785|NCT02891018|Device|paclitaxel controlled release balloon catheter Vasoguard TM|
15999786|NCT02891018|Device|paclitaxel release coronary balloon catheter SeQuent Please|
15999787|NCT02891005|Device|paclitaxel controlled release balloon catheter (VasoguardTM)|paclitaxel controlled release balloon catheter implantation for small vessel lesion
15999788|NCT02891005|Device|common balloon catheter (Maverick2)|common balloon catheter implantation for small vessel lesion
15999789|NCT02890992|Drug|alirocumab SAR236553 (REGN727)|Pharmaceutical form: solution Route of administration: subcutaneous injection
15999791|NCT02890992|Drug|ezetimibe|Pharmaceutical form:tablet Route of administration: oral
15999792|NCT02890992|Drug|cholestyramine|Pharmaceutical form:tablet Route of administration: oral
15999793|NCT02890992|Drug|fenofibrate|Pharmaceutical form: tablet Route of administration: oral
15999794|NCT02890992|Drug|omega-3 fatty acids|Pharmaceutical form: tablet Route of administration: oral
15999795|NCT02890992|Drug|nicotinic acid|Pharmaceutical form: tablet Route of administration: oral
15999796|NCT02890979|Other|Cytology Specimen Collection Procedure|Undergo cytology specimen collection procedure using a swallowable sponge cell sampling device
15999797|NCT02890979|Other|Laboratory Biomarker Analysis|Correlative studies
15999798|NCT02890979|Other|Quality-of-Life Assessment|Ancillary studies
15999799|NCT02890979|Device|Swallowable Sponge Cell Sampling Device|Undergo cytology specimen collection procedure using a swallowable sponge cell sampling device
15999800|NCT02890966|Drug|SHR4640|Day1~Day7:oral administration
15999801|NCT02890966|Drug|placebo|Day1~Day7:oral administration
15999802|NCT02890953|Drug|Pneumostem|direct intracerebroventricular injection of mesenchymal stem cells via ventricular tap
15999803|NCT02890953|Drug|Normal saline|direct intracerebroventricular injection of normal saline via ventricular tap
15999804|NCT02890940|Behavioral|Pet Therapy|"Patients will be asked to complete the standardized QLQ-C30/BN20 questionnaires. Following completion of the questionnaires, a trained pet therapy dog will be brought to the patients for approximately 10 minutes. After approximately 10 minutes, the dog will be removed and the patients will be asked to re-complete the standardized QLQ-C30/BN20 questionnaires. Patients will be photographed and videographed during this time.
~Finally, patients will be asked to talk about how their perspectives on life have changed with their diagnosis. These responses will be captured for use in the art exhibit created from images collected during the study."
15999805|NCT02890927|Other|Cardio-geriatric co-management|"A comprehensive geriatric assessment on admission will stratify patients in groups:
~Low risk patients are expected to do well and will not receive co-management.
~Medium risk patients are expected to develop complications. A geriatric nurse will visit the cardiology wards daily to co-manage these patients aiming to prevent complications by coordinating interdisciplinary care, implementing protocols, perform assessments and bedside education. The geriatric nurse will work collaboratively with the cardiology ward staff based on a shared decision making. Patients will receive early rehabilitation and discharge planning.
~High risk patients have an acute geriatric syndrome. The geriatric nurse will visit the cardiology wards (see above), and a geriatrician will co-manage the acute geriatric syndrome(s). The geriatrician will work collaboratively with the cardiology ward staff based on a shared decision making. Patients will receive early rehabilitation and discharge planning."
15999806|NCT02890914|Other|Transvaginal Ultrasound Educational DVD|"American Institute of Ultrasound in Medicine, Gynecology: Beginners Only®"
15999807|NCT02890888|Other|hyperbaric oxygen treatment|Patients are treated in a hyperbaric oxygen chamber for 1 hour at 2ATA, 10 times over 2 consecutive weeks, 5 times per week
15999808|NCT02890875|Other|Ethanol lock|
15999809|NCT02890875|Other|Heparin lock|
15999810|NCT02890849|Other|Liquid biopsy|
15999811|NCT02890836|Drug|Antihypertensiva, mainly Metyldopa|
15999812|NCT02890823|Drug|Cholecalciferol|
15999813|NCT02890810|Other|Real Acupuncture with Electrical Stimulation|Acupuncture is a therapy commonly used in East Asian countries, where the practitioner insert thin needles at specific body sites in order to relieve pain and illnesses. Recent studies found low frequency electricity applied through acupuncture needles can lead to profound pain relief by increasing endorphin levels in the central nervous system. Electroacupuncture will thus be used as the active intervention to treat chronic low back pain in this clinical study.
15999814|NCT02890810|Other|Simulated Acupuncture with Electrical Stimulation|This intervention serves as the placebo control of the active intervention. Sterile acupuncture needles and the ITO electrical stimulators will be used in this intervention. But special care will be taken to have this intervention mimic the real treatment yet remaining as physiologically inert as possible.
15999815|NCT02890797|Radiation|radiology|The investigators propose to performed a chest ultrasound in infants (<24 months) admitted for bronchiolitis with an available chest X-ray
15999816|NCT02890784|Drug|dasatinib (SPRYCEL®)|Treatment optimization for patients with chronic myeloid leukemia (CML)
15999817|NCT02890771|Procedure|Tooth Brushing with Dentifrice|Tooth Brushing with Dentifrice (Standard Tooth Brushing technique will be demonstrated by using same type of tooth brush and toothpaste).
15999818|NCT02890771|Procedure|Turmeric Massaging|:-Tooth Brushing with Dentifrice (with same type of tooth brush and toothpaste) and massaging with whole Turmeric Powder.
15999819|NCT02890771|Procedure|SRP with turmeric massaging|on one side of the arch only Scaling and Root Planing(SRP) to be done, while on the other side, after the Scaling and Root Planing massaging with whole Turmeric Powder shall be carried out by the patients/subjects
15999820|NCT02890758|Biological|Natural Killer (NK) Cells|Dose escalation of Natural Killer (NK) Cells from two infusion of starting at Dose Level 1 (1x10^7 cells/kg), dose Level-1 (1x10^6 cells/kg) if 2 of 6 patients at Level 1 develop DLTs. Escalation to dose level 2 (2.5X10^7) and Dose level 3 (5X10^7) is dependent on DLT
15999821|NCT02890758|Biological|ALT803|given at 6mcg/kg weekly for four weeks
15999822|NCT02890745|Drug|Empagliflozin|
15999823|NCT02890745|Drug|Placebo|
15999824|NCT02890732|Device|Appet HEART|smartphone application prototype of personalized care of patients after hospitalization for coronary artery disease
15999825|NCT02890719|Drug|Grazoprevir 100 mg/day|Grazoprevir 100 mg/ day 12 weeks
15999826|NCT02890719|Drug|Elbasvir 50 mg/d|Elbasvir 50 mg/day 12 weeks
15999827|NCT02890719|Drug|Grazoprevir 100 mg/day|Grazoprevir 100 mg/day 16 weeks
15999828|NCT02890719|Drug|Elbasvir 50 mg/day|Elbasvir 50 mg/d 16 weeks
15999829|NCT02890719|Drug|Ribavirin 1200 mg/day|Ribavirin 1200 mg/day 16 weeks
15999830|NCT02890706|Device|Iodine Mapping using Subtraction in Pulmonary Embolism Computed Tomography versus Dual Energy Computed Tomography|Compare two techniques of the CT scanner
15999903|NCT02890160|Device|XIENCE|Everolimus Eluting Coronary Stent System
15999904|NCT02890108|Dietary Supplement|Sugar sweetened beverages|350 cc (1 can) of sugar sweetened beverage
16000629|NCT02884115|Drug|benzathine penicillin|
15999831|NCT02890693|Behavioral|interdisciplinary lifestyle and psychosocial intervention|The multidimensional interdisciplinary lifestyle and psychosocial intervention will be offered on top of usual care. It will consist of individual sessions (face-to-face or telephone contact) with different members of the interdisciplinary team (dietician, physiotherapist, clinical psychologist or coach) and two group sessions. It will take place during pregnancy and during the first year postpartum.
15999832|NCT02890680|Procedure|Platelet-rich fibrin|
15999833|NCT02890680|Procedure|Control group|
15999834|NCT02890667|Other|Incident cancer|The number of incident cancer cases
15999835|NCT02890654|Other|First time measure|"Initial Interview
~Initial Survey,
~Quality of life Scale
~Kinesitherapy Review
~Anxiety Scale"
15999836|NCT02890654|Other|Second time measure|"Kinesitherapy review
~Second survey including numeric scale of pain
~Anxiety scale
~Scoliosis Research Society 22 quality of life scale"
15999837|NCT02890654|Other|Third time measure|"Scoliosis Research Society 22 quality of life Scale
~Anxiety scale
~Numeric scale of pain
~Kinesitherapy review"
15999838|NCT02890641|Genetic|Sequencing of paired blood-brain DNA samples|Sequencing of paired blood-brain DNA samples to search for genetic abnormalities
15999839|NCT02890615|Behavioral|Depression self-care|Toolkit and coaching
15999840|NCT02890602|Drug|Darbepoetin alfa|Darbepoietin alfa will be administered subcutaneously at a fixed dose of 360㎍. If it is impossible, administration by intravenous infusion is okay.
15999841|NCT02890602|Drug|R-CHOP|R-CHOP regimen is a practical procedure in patients with Diffuse Large B-cell Lymphoma. Darbepoietin alfa will be administered to these patients.
15999842|NCT02890589|Device|SYNERGY stent|"Coronary angiography will assess the presence of at least one eligible coronary lesion requiring stent implantation before revascularization by angioplasty.
~Stent will be implanted according to manufacturer's and competent authority recommendations."
15999843|NCT02890589|Device|ABSORB (Everolimus-eluting Bioresorbable Vascular Scaffold)|"Coronary angiography will assess the presence of at least one eligible coronary lesion requiring stent implantation before revascularization by angioplasty.
~Stent will be implanted according to manufacturer's and competent authority recommendations."
15999844|NCT02890576|Other|telemedicine|Monitoring of patients with cochlear implant with sessions of telemedicine
15999845|NCT02890563|Device|Class II Compression Stockings|
15999846|NCT02890537|Drug|Core decompression/PREOB® implantation|All subjects received a core decompression under general anesthesia combined with the implantation of PREOB® into the necrotic lesion (single administration).
15999847|NCT02890537|Drug|Core decompression/BMC implantation|All subjects received a core decompression under general anesthesia combined with the implantation of BMC into the necrotic lesion (single administration).
15999848|NCT02890524|Device|night guard|60 days before and after intervention with the night guard
15999849|NCT02890524|Device|placebo night guard|60 days before and after intervention with the placebo night guard
15999850|NCT02890511|Drug|Paclitaxel|Oral administration on day 1,8,15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed consent.
15999851|NCT02890485|Procedure|Dry Needling|Dry needling consists of small, monofilament needles that are administered directly into the tissue and manipulated to make the muscle relax for pain relief. This technique is used to treat dysfunctions in skeletal muscle and connective tissue to help diminish pain, reduce impairments of body structure and restore function. Dry needling will be performed in the gluteal or the quadriceps muscle groups depending upon group randomization.
15999852|NCT02890485|Procedure|Sham Dry Needling|"The same overall procedures will be used as in the true dry needling groups and applied to the same muscle groups (gluteal or quadriceps) depending upon ground randomization. Sham dry needling will be performed using a commercially available sham needling system commonly.This set-up utilizes a blunt tipped needle. When the sham needle is pressed downward, the barrel of the needle retracts into the handle, giving the appearance of insertion of the needle through the skin. This also creates pressure on the subject's skin, increasing the sensation of dry needling. Patients will not be allowed to observe the areas being needled or sham needled."
15999853|NCT02890485|Other|Physical Therapy|Physical Therapy and exercise as determined by the examining clinician based on the patients specific impairments and functional limitations. All subjects enrolled in this study will receive an initial physical therapy (PT) evaluation and then 2 additional PT sessions a week a part. Interventions and prescribed home exercises will be specific to the patients' primary individual impairments as determined during the initial PT evaluation. These interventions reflect current evidence, but will not be restrictive to specific exercises; prescribed exercises will be deemed appropriate based on the treating PTs' examination, evaluation, and identification of each patients' primary deficits, impairments, functional limitations, and current literature.
15999854|NCT02890459|Other|Prize incentive - Low|Low expected prize value.
15999855|NCT02890459|Other|Prize incentive - High|High expected prize value.
15999856|NCT02890459|Other|Escalating payment incentive|"The incentives will increase in value when participants are found to meet the pre-specified virologic suppression criteria at 6 weeks, 3 months and 6 months.
~If the virologic threshold for an incentive is missed at the 6 week or 3 month time-point, the subsequent incentive for an undetectable HIV viral load will be reset to the initial incentive value."
15999857|NCT02890459|Other|Travel Voucher|Travel voucher to assist with linkage to care.
15999858|NCT02890459|Other|Standard care|Includes HIV viral load and treatment adherence counseling.
15999859|NCT02890459|Behavioral|Fixed Incentive - Prize|Men are informed that if they come for HIV testing, they will receive a specific prize (gain framing). The prize will be an item worth the same amount in US dollars as loss aversion and the expected value of a lottery prize. This gain-framed incentive resembles the form that incentives usually take in most studies and serves as a comparison to the lottery-based and loss-framed incentives.
15999860|NCT02890459|Behavioral|Loss Aversion - Prize|The prizes are worth approximately the same amount as the fixed incentive and expected value of a lottery prize. At the time of randomization, study staff will inform the participant that he has won a prize. Staff will ask the participant to choose a specific prize from several choices, and then provide an opportunity for the participant to see the prize. Study staff will then tell participants that they will lose the prize if they do not participate in HIV testing. In this way, the incentive is framed as a loss rather than a gain, thereby leveraging loss aversion while not requiring men in very low-income settings to experience an actual loss.
15999861|NCT02890459|Behavioral|Lottery - Prize|"Men are entered in a lottery that offers a chance to win high-value prizes after testing for HIV at a community health campaign. Staff will emphasize that only those who come for HIV testing will be entered into the lottery and that not everyone will win a prize. Participants were informed at enrollment about the list of prizes and corresponding probabilities of winning them, in terms that are understandable to men with low numeracy (e.g., 1 in 20 rather than 5%). The probabilities of winning prizes varied between 1-5%, with higher value prizes having lower probability."
15999862|NCT02890459|Behavioral|Fixed Incentive - Voucher|A standard gain-framed incentive arm in which participants will be offered a voucher for coming for a repeat HIV test in the future.
15999863|NCT02890459|Behavioral|Loss Aversion - Deposit|A loss-aversion framed incentive in which participants will be asked to voluntarily make a deposit that can be retrieved, with interest on the deposit, if they come for an HIV test in the future (i.e. for repeat testing)
15999864|NCT02890446|Behavioral|upper arm training on the InMotion 2 shoulder robot|"Both groups practiced shoulder and elbow exercises on a robotic arm device under an external focus or internal focus practice condition.
~Practiced arm reaching in a clock-like design to facilitate horizontal shoulder flexion, extension, abduction, adduction.
~12 sessions--3 times a week for 4 weeks"
15999865|NCT02890394|Other|Suboccipital inhibition technique|Suboccipital inhibition technique involves the placement of the hands of the physiotherapist under the patient's head so that fingers can feel the spinous processes of the cervical vertebrae. Then fingers slowly leads upward to contact the occipital condyles. At this point the investigator should gently move your fingers down, finding the space between the condyles and the spinous process of the axis. Remember that the atlas has no spinous process. Then, flexing the metacarpophalangeal joints at 90 degrees, slowly raises the skull
15999866|NCT02890381|Biological|RSV LID cp ΔM2-2 Vaccine|10^5 plaque-forming units (PFUs); administered as nose drops
15999867|NCT02890381|Biological|Placebo|Isotonic diluent, administered as nose drops
15999868|NCT02890368|Drug|TTI-621 Monotherapy|"TTI-621 (SIRPα-IgG1 Fc) is a soluble recombinant fusion protein created by directly linking the sequences encoding the N-terminal CD47 binding domain of human SIRPα with the Fc domain of human immunoglobulin (IgG1). TTI-621 acts by binding human CD47 and preventing it from delivering an inhibitory do not eat (antiphagocytic) signal to macrophages."
15999869|NCT02890368|Drug|TTI-621 + PD-1/PD-L1 Inhibitor|TTI-621 will be given in combination with one of the following programmed death-1 (PD-1) or programmed death-ligand-1 (PD-L1) inhibitors: nivolumab, pembrolizumab, durvalumab, avelumab, or atezolizumab administered on Day 1. Subjects in this cohort must have a cancer diagnosis for which a PD-1/PD-L1 inhibitor is approved by the FDA or listed in the National Comprehensive Cancer Network (NCCN) Guidelines.
15999870|NCT02890368|Drug|TTI-621 + pegylated interferon-α2a|TTI-621 will be given in combination with pegylated interferon-α2a. Subjects in this cohort must have a cancer diagnosis for which pegylated interferon-α2a is approved by the FDA or listed in the National Comprehensive Cancer Network (NCCN) Guidelines.
15999871|NCT02890368|Other|TTI-621 + T-Vec|TTI-621 will be given in combination with talimogene laherparepvec (T-Vec). Subjects in this cohort must have unresectable melanoma.
15999872|NCT02890368|Other|TTI-621 + radiation|TTI-621 will be given following radiation to the target plasmacytoma. Subjects in this cohort must have relapsed multiple myeloma with bony or soft tissue plasmacytoma(s).
15999873|NCT02890355|Drug|Fluorouracil|Given IV
15999874|NCT02890355|Drug|Fluorouracil|Given IV bolus
15999875|NCT02890355|Drug|Irinotecan Hydrochloride|Given IV
15999876|NCT02890355|Other|Laboratory Biomarker Analysis|Correlative studies
15999877|NCT02890355|Drug|Leucovorin Calcium|Given IV
15999878|NCT02890355|Drug|Veliparib|Given PO
15999879|NCT02890329|Drug|Decitabine|Given IV
15999880|NCT02890329|Biological|Ipilimumab|Given IV
15999881|NCT02890316|Other|Homeopathy remedy|Homeopathy remedy, prescribed by a physician and prepared by licensed pharmacy.
15999882|NCT02890316|Radiation|Radiation as adjuvant therapy for breast cancer|Daily radiation therapy.
15999883|NCT02890303|Device|Zepto System|Anterior Capsulotomy using the Zepto System.
15999884|NCT02890290|Dietary Supplement|Marine Protein hydrolysate|The participants will take the supplement in form of tablets and will be instructed to take five tablets twice a day, preferably in relation to meals, however, not the dinner meal. Each tablet contains 300 mg of marine protein hydrolysates (Nx6.25). The tablets are produced by Flexipharma AS.
15999885|NCT02890290|Dietary Supplement|Placebo|Placebo tablets will be made based on gum arabicum. The tablets are produced by Flexipharma AS.
15999886|NCT02890277|Device|the high intensity focused ultrasound (Mianyang Sonic electronic LLC)|
15999887|NCT02890277|Drug|Fu Tiankang disposable vaginal filling suppository, Albothyl (Policresulen Solution) , and the gynecologic medical antimicrobial dressing gel (chitosan gel).|
15999888|NCT02890238|Drug|Clomiphene citrate|50mg (clomid,) orally 2 times/day from 2nd- 7th day of the cycle
15999889|NCT02890238|Drug|sildenafil citrate|20mg tab from 7th-11th day of the same cycle orally 3times/day
15999890|NCT02890238|Drug|Placebo|tab from 7th-11th day of the same cycle orally 3times/day
15999891|NCT02890225|Procedure|3 days after|in 3 days after RIRS.
15999892|NCT02890225|Procedure|10days after|in10 days after RIRS.
15999893|NCT02890225|Procedure|EPVL performed in30days after RIRS|Patients in Group C undergo EPVL in630days after RIRS.
15999894|NCT02890212|Dietary Supplement|selenium supplementation|administration of selenium pills (400 micrograms) for randomized subjects
15999895|NCT02890212|Dietary Supplement|placebo|administration of placebo pills for randomized subjects
15999896|NCT02890199|Drug|Bupivacaine liposomal|
15999897|NCT02890199|Drug|Lidocaine|
15999898|NCT02890186|Device|Narcotrend|the investigator modified the effect-site target concentrations by NI.If NI fall down to 46 and keep 46 more than 30 seconds,propofol and remifentanil were infused as feedback automatically to achieve the target NI of 26-46.
15999899|NCT02890186|Other|experience|the investigator modified the effect-site target concentrations of both drugs without minimum or maximum concentration limits without using the Narcotrend monitor only depend on the experience of anesthesiologist.
15999900|NCT02890173|Drug|CS-3150|
15999901|NCT02890173|Drug|Eplerenone|
15999902|NCT02890160|Device|Firesorb|Sirolimus Target Eluting Bioresorbable Vascular Scaffold
15999905|NCT02890108|Dietary Supplement|Artificially sweetened beverages|350 cc (1 can) of artificially sweetened beverage
15999906|NCT02890095|Procedure|Breast cancer surgery|"First, 2 specific adipose tissue samples will be performed during the surgery :
~1 sample near the tumor, to measure the contaminants (dioxins, PCBs, organochlorine pesticides, polybrominated compounds)
~1 remote sample of the tumor bed, superficial, at least 5 cm from the tumor, to be used to determine the level of expression of hormone receptors and to establish the expression profiles, after cutting and inclusion in paraffin blocks for marking IHC.
~These withdrawals are made during surgery, during surgery, as part of the intervention and the remodeling of the mammary gland (standard care for patients). This is unused balance for diagnostic.
~Before anaesthesia : specific blood samples (for the determination of circulating pollutants and for the analysis of gene polymorphism)"
15999907|NCT02890095|Procedure|plastic surgery|"The excision piece will follow the classical pathological circuit.
~A specific charge of subcutaneous adipose tissue will be performed as part of research on the surgical specimen. This sample will be used:
~measuring contaminants (dioxins, PCBs, organochlorine pesticides, polybrominated compounds)
~to determine the level of expression of hormone receptors and to establish the expression profiles, after cutting and inclusion in paraffin blocks for marking IHC. These samples are all made during surgery, for usual care surgery these patients.
~Before anaesthesia : specific blood samples (for the determination of circulating pollutants and for the analysis of gene polymorphism)"
15999908|NCT02890082|Drug|Tamoxifen stim in early follicular phase|"Day cycle of the patient when ovarian stimulation begin (early follicular phase) = D1 to D3
~Stimulation with simultaneously: TAM (tamoxifen) 60mg / day + FSH® 150 to 300 IU / day (following ovarian reserve)
~Monitoring (ultrasound + blood test E2, LH (luteinizing hormone) and P) every 2 to 3 days +/- dose adjustment of FSH
~Ovulation by blocking the GnRH antagonist (gonadotropin-releasing hormone : CETROTIDE) introduced according to the usual criteria,
~Continued monitoring (ultrasound + blood test E2, LH and P) every 2 to 3 days
~Triggering ovulation by OVITRELLE ® 250μg according to the usual criteria
~35 h after the onset, oocyte puncture transvaginally the gynecology unit under local or general anesthesia."
15999909|NCT02890082|Drug|Tamoxifen stim in late follicular phase|"Day cycle of the patient when ovarian stimulation begin (late follicular phase) = D4 to D14
~Monitoring (ultrasound + blood test E2, LH and P) until a follicle of 15 mm
~Ovulation induction by OVITRELLE® 250μg.
~Continued monitoring (ultrasound + blood test E2, LH and P) 4 days after OVITRELLE® to the proper stage for the beginning of stimulation.
~Stimulation with simultaneously: TAM 60mg / day + FSH® 150 to 300 IU / day (following ovarian reserve) + CETROTIDE
~Continued monitoring (ultrasound + blood test E2, LH and P) every 2 to 3 days +/- adaptation of FSH
~Triggering ovulation by OVITRELLE ® 250μg according to the usual criteria
~35 h after the onset, oocyte puncture transvaginally the gynecology unit under local or general anesthesia."
15999910|NCT02890082|Drug|Tamoxifen stim in luteal phase|"Day cycle of the patient when ovarian stimulation begin (luteal phase) = D15 to D28
~1 or 2 Monitoring (ultrasound + blood test E2, LH and P) to check the validity of the post-ovulatory phase
~Stimulation with simultaneously: TAM 60mg / day + FSH® 150 to 300 IU / day (following ovarian reserve) + CETROTIDE
~Continued monitoring (ultrasound + blood test E2, LH and P) every 2 to 3 days +/- adaptation of FSH
~Triggering ovulation by OVITRELLE ® 250μg according to the usual criteria
~35 h after the onset, oocyte puncture transvaginally the gynecology unit under local or general anesthesia"
15999917|NCT02890056|Behavioral|H2GO!|
15999918|NCT02890043|Procedure|robot-assisted spine surgery|robot-assisted spine surgery using Tirobot system
15999919|NCT02890043|Procedure|free-hand surgery|traditional free-hand surgery
15999920|NCT02890043|Device|TiRobot system|a robot-assisted spine surgery system
15999921|NCT02890030|Behavioral|Questionnaire|"Neurotoxicity
~Medications of interest
~General health
~Family history"
15999922|NCT02890017|Other|postoperative hotel|"Outpatient surgery First night stay in a defined patient-hotel Patient come for consultation the next morning of surgery to remove the catheter and/or the compressive bandage. The absence of adverse events is checked, the discharge is confirmed and the evaluation questionnaire is given to the patient.
~Postoperative consultation at 1 and 3 months."
15999923|NCT02890017|Other|conventional hospitalization|Hospitalization for surgery and first postoperative night stay. Postoperative consultation at 1 and 3 months
15999924|NCT02889991|Other|High Intensity Dry Needling|"This technique follows the criteria established by Dr Hong C-Z. This technique is known as fast in and fast out technique and uses repeated insertion of the acupuncture needle in the myofascial trigger point, with the aim to get multiple local twitch responses. The technique ends when the local twitch responses disappear."
15999925|NCT02889991|Other|Low intensity Dry Needling|Technique proposed by the main investigator and based on the studies of Professor Dr. Jay P. Shah and the mechanisms of neuromodulation that transmits us the acupuncture scientific evidence.
15999926|NCT02889991|Other|Fascial Mechanotransduction Dry Needling|"The Fascial Mechanotransduction Dry Needling Technique, strikes with the acupuncture needle until it reaches and pierces the myofascial trigger point. Then the acupuncture needle is rolled in the connective tissue, which causes an intense coupler that we define as needle grasp. Finally, the acupuncture needling is pulled-out twice.
~The screwing and the two pull-out of the acupuncture needle is performed in the infraspinatus and supraspinatus muscles and we describe it as mechanotransduction cycle. Each cycle lasts 30 seconds and the whole technique lasts 3 minutes per session."
15999927|NCT02889991|Other|Technique Placebo of Dry Needling|"Technique with a total duration of 3 minutes per session:
~To locate the myofascial trigger points of infraspinatus and supraspinatus muscles and put each bridle on them.
~Monitor longitudinally taut band, with index and middle fingers.
~Percuss with tube and needle placebo (Sham needle) on Infraspinatus.
~Remove the tube and needle placebo from the device. Reintroducing the placebo needle into the tube and strike on the supraspinatus. Repeat this sequence without interruption for 3 minutes.
~Remove the bridles and perform hemostasis with cotton.
~We will give end to the technique placebo of dry needling."
15999963|NCT02889692|Drug|Gefitinib®|"Gefitinib®,Iressa, 250 mg oral once a day until progression or unacceptable toxicity develops."
15999964|NCT02889692|Drug|Icotinib®|"Icotinib®,Conmana 125 mg oral three times a day until progression or unacceptable toxicity develops."
15999928|NCT02889952|Device|Near infrared camera (NIR)|"Surgical field was examined with NIR, during a few minutes (<5') with room lights switched off, to avoid parasite lights, then conventional open thyroidectomy was resumed conventionally. Real-time images, evocative of autofluorescent parathyroids, were checked visually.
~NIR consisted of a 750 nm class 1 laser excitation, with a power <20mW/cm2 (5 times less than the limit of 100mw/cm2, fixed by the international norm IEC 60601-2-41). It was provided by the Fluobeam® camera, which was inserted into a sterile cover and hold at a 15-20 cm distance from the patient. The system has an FDA 510(k) authorization for clinical use in parathyroid surgery and a European Community certification (Class 1 device)."
15999929|NCT02889939|Other|UC + ETT|"UC: A 3-week UC period, where the participants were not offered any new rehabilitation activities but were allowed to continue their regular treatment for a maximum of 3 hours per week.
~ETT: The rehabilitation facilities were located in a climate that allowed and encouraged both indoor and outdoor activities. The ETT was individually tailored. Participants exercised in the same room/place as the other participants in groups of 4-9. Physical exercise was scheduled 3.5-6 hours per day, 5½ days per week for 3 weeks. The training was characterized by repetitive mass practice of gradually increasing difficulty and noncompensatory strategies, such as enforcing use of the affected side.
~Beyond scheduled activities, participants were encouraged to physically engage themselves in a challenging outdoor environment."
15999930|NCT02889926|Biological|a swab according to the method of Levine|A swab according to the method of Levine: choose the pathological area by pressing the swab over the area, with a rotation supported on at least 1 cm² for 5 seconds, to well up from the liquid.
15999931|NCT02889926|Biological|Bacteriological referred to biopsy|Bacteriological referred to biopsy: (This is the hole protocol) Choose the pathological area, debridement of the wound to the pad and a scalpel, cleaning with betadine followed by rinsing with saline, local anesthesia with xylocaine, 6 mm punch for drawing a carrot, put into a sterile container
15999932|NCT02889913|Other|No intervention only description|No intervention only description
15999933|NCT02889900|Drug|cediranib and olaparib|"Cediranib tablets oral dose 30 mg once daily; Olaparib(Lynparza) tablet 200 mg twice daily
~Dose reduction for both products is allowed"
15999934|NCT02889874|Radiation|Omission of radiation therapy|Omission of radiation therapy (adjuvant endocrine therapy only).
15999935|NCT02889861|Drug|IMCgp100|Bispecific soluble human leukocyte antigen-A2 (HLA-A2) restricted gp100-specific TCR fused to anti-CD3
15999936|NCT02889848|Other|Saline|Saline injection
15999937|NCT02889848|Drug|EN3835|Comparison of maximum marketed dose and multiple doses EN3835
15999938|NCT02889835|Device|Supreme Universal Restorative|
15999939|NCT02889835|Device|Supreme Flowable Restorative|
15999940|NCT02889835|Device|Bulk Fill Flowable Restorative|
15999941|NCT02889822|Drug|Alprostadil Liposomes for Injection|"Single-dose tolerance test:10ug/20ug/50ug/100ug/200ug/300ug/400ug of Alprostadil Liposome for Injection,ivgtt,qd
~Multiple-dose tolerance test:100ug,ivgtt,qd,continuous administration for 7 days."
15999942|NCT02889809|Drug|Fluticasone furoate|Fluticasone furoate will be supplied as 50 mcg per blister dry white powder for inhalation using ELLIPTA inhaler.
15999943|NCT02889809|Drug|Placebo|Placebo will be supplied as dry white powder Lactose for inhalation using ELLIPTA inhaler.
15999944|NCT02889809|Drug|Montelukast|Montelukast will be supplied as 4 mg chewable tablet (5 year old subjects) and as 5 mg chewable tablet (>=6 year old subjects)
15999945|NCT02889809|Drug|Short Acting Beta 2 Agonist|Albuterol/salbutamol will be supplied as inhalation aerosol or nebulizer.
15999946|NCT02889796|Drug|Filgotinib|200 mg or 100 mg tablet(s) administered orally once daily
15999947|NCT02889796|Drug|Placebo to match filgotinib|Tablet(s) administered orally once daily
15999948|NCT02889796|Drug|Adalimumab|40 mg administered via subcutaneous injection once every two weeks
15999949|NCT02889796|Drug|Placebo to match adalimumab|Administered via subcutaneous injection once every two weeks
15999950|NCT02889796|Drug|MTX|Commercially sourced tablet(s) administered orally
15999951|NCT02889783|Other|record of urethral pain sensation during urodynamics study|Record of pain using a VAS scale during the first catheterizing of urodynamics study, at every centimeter
15999952|NCT02889770|Other|PEEP titration|Exposure to different PEEP levels
15999953|NCT02889757|Drug|Acteylcysteine|randomized into three arms
15999954|NCT02889744|Device|Arctic Sun|Targeted temperature management for 24 hours with core temperature 36℃ or 33℃
15999955|NCT02889718|Device|CONCERT-CL® station|"During cancer surgery (surgery > 1 hour), CONCERT-CL® station will be used in accordance with its CE marking to administer anesthetic agents:
~Port B = open loop: Analgesic
~Port A = closed loop: Hypnotic
~Port C = closed loop: Curare"
15999956|NCT02889718|Other|Surgery|Regardless of the type of surgery the patient receives for his cancer, this surgery must be greater than 1 hour.
15999957|NCT02889705|Other|Ultrasonographic examination|
15999958|NCT02889692|Drug|YiQiFang|"Prescriptions formulated into TCM granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi, benefiting Yin and detoxication recipe.
~YiQiFang: Patients with Qi deficiency syndrome are administered two packages of each benefiting Qi and detoxication recipe, four packages, twice a day, until progression or unacceptable."
15999959|NCT02889692|Drug|YangYinFang|"Prescriptions formulated into TCM granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi, benefiting Yin and detoxication recipe.
~YangYinFang: Patients with Yin deficiency syndrome are administered two packages of each benefiting Yin and detoxication recipe, four packages, twice a day, until progression or unacceptable."
15999960|NCT02889692|Drug|YiQiYangYinFang|"Prescriptions formulated into TCM granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi, benefiting Yin and detoxication recipe.
~YiQiYangYinFang: Patients with Qi and Yin deficiency syndrome are administered one package of each benefiting Qi and benefiting Yin and two packages of detoxication recipe, four packages, twice a day, until progression or unacceptable."
15999961|NCT02889692|Drug|placebo granules|Oral granules, which the taste and smell are similar to experimental TCM granules, has no therapeutic effect, four packages, twice a day, until progression or unacceptable.
15999962|NCT02889692|Drug|Erlotinib®|"Erlotinib®,tarceva, 150 mg oral once a day until progression or unacceptable toxicity develops."
15999965|NCT02889679|Procedure|Underwater resection|Underwater resection of eligible lesions will be performed with air exclusion (air will be suctioned and completely removed) without submucosal injection in a partially collapsed colon lumen filled with water. Water will be infused with the foot pedal to facilitate visualization during UR and there will be no limit to the amount of water infused. Hot and cold resection techniques will be utilized.
15999966|NCT02889679|Procedure|Conventional (gas distended colon) resection|Conventional polypectomy of eligible lesions will be performed in a gas distended colon. Hot and cold resection techniques will be utilized. Submucosal fluid injection with a solution containing hydroxyethyl starch, dilute epinephrine and a contrast agent may be used with conventional techniques for large (≥1cm) and/or flat lesions. There will be no limit to the amount of submucosal injection used.
15999967|NCT02889679|Procedure|Standard polypectomy|Standard polypectomy will be performed for diminutive (<6mm), pedunculated and semi-pedunculated lesions that do not fall under the inclusion criteria for the study. These lesions will be removed in a gas distended colon with a 9mm firm, thin wire cold snare or snare electrocautery for large (≥1cm) lesions.
15999968|NCT02889666|Drug|Cisplatin|Procedure: Preoperative chemotherapy using Cisplatin (60mg) as single agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery.
15999969|NCT02889666|Drug|Carboplatin|Procedure: Preoperative chemotherapy using Carboplatin (400mg) as single agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery.
15999970|NCT02889666|Drug|Docetaxel|Procedure: Preoperative chemotherapy using Docetaxel (120mg) as single agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery.
15999971|NCT02889666|Drug|Gemcitabine/Carboplatin|Procedure: Preoperative chemotherapy using Gemcitabine (200mg) and Carboplatin (400mg) as combinational therapy agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery.
15999972|NCT02889666|Drug|Gemcitabine/Cisplatin|Procedure: Preoperative chemotherapy using Gemcitabine (200mg) and Cisplatin (60mg) as combinational therapy agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery.
15999973|NCT02889666|Drug|Docetaxel/Oxaliplatin|Procedure: Preoperative chemotherapy using Docetaxel (120mg) and Oxaliplatin (200mg) as combinational therapy agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery.
15999974|NCT02889666|Drug|Docetaxel/Carboplatin|Procedure: Preoperative chemotherapy using Docetaxel (120mg) and Carboplatin (400mg) as combinational therapy agent was performed 30 days before surgery through intravenous (IV) administration. IV administration once every 7 days, totally 4 cycles. There is a 2-day interval between the last dose and surgery.
15999975|NCT02889666|Drug|Placebo|Regular placebo in replacement of agent-specific chemotherapy was supplied to these patients.
15999976|NCT02889653|Drug|Any oral antithrombotics (antiplatelets or anticoagulants)|
15999977|NCT02889640|Other|SAGA Innovations|An intensive math tutoring program
15999978|NCT02889640|Other|Scale-up tutors|Tutors who have been selected for hire via the one in three-and-a-half randomization process
15999979|NCT02889640|Other|Standard Tutors|Tutors who have been selected for hire via SAGA's standard hiring process, which does not entail randomization
15999980|NCT02889627|Drug|Fecal microbiota suspension|The prepared microbiota suspension was infused into the participates' mid-gut or lower gut.
15999981|NCT02889614|Other|Hypobetalipoproteinemia diagnosis (LDL-C ≤ 50 mg/dL without hypolipidemic treatment)|LDL-C dosage.
15999982|NCT02889601|Other|Psycho-behavioural assessment|DAPHNE Scale
15999983|NCT02889562|Drug|Apixaban|Study arm that patient can be randomized to. Apixaban is a novel, orally active, potent, direct selective inhibitor of coagulation FXa that directly and reversibly binds to the active site of FXa and exerts anticoagulant and antithrombotic effects by diminishing the conversion of prothrombin to thrombin.
15999984|NCT02889562|Drug|Warfarin|Study arm that patient can be randomized to. Warfarin therapy has been the mainstay of therapy for patients with POAF. While the duration of therapy is usually short (3-4 weeks), complications of anticoagulation do occur. Additionally, warfarin therapy for POAF is associated with increased length of stay, need for monitoring, and bleeding complications.
15999985|NCT02889549|Drug|ticagrelor|Different doses of ticagrelor (22.5/45/90 mg, twice daily, oral) treatment for 1 month
15999986|NCT02889549|Drug|clopidogrel|Standard dose of clopidogrel (75 mg, once daily, oral) treatment for 1 month
15999987|NCT02889536|Other|Focus group interviews|Focus group interviews. Two groups with patients referred to repair of parastomal bulging and three groups with patients attending the outpatient stoma clinics
15999988|NCT02889523|Drug|Tazemetostat|Tablets 200 mg, to be administrated per os
15999989|NCT02889523|Drug|Rituximab|375 mg/m²/dose, D1
15999990|NCT02889523|Drug|Cyclophosphamide|750 mg/m²/dose, D1
15999991|NCT02889523|Drug|Vincristine|1.4 mg/m²/dose (max 2 mg), D1
15999992|NCT02889523|Drug|Doxorubicin|50 mg/m²/dose, D1
15999993|NCT02889523|Drug|Prednisolone|40 mg/m2 in the morning D1 to D5
15999994|NCT02889510|Drug|liraglutide|7-week subcutaneous liraglutide once daily
15999995|NCT02889510|Drug|placebo|7-week subcutaneous placebo once daily
15999996|NCT02889497|Biological|the first batch vaccine|
15999997|NCT02889497|Biological|the second batch vaccine|
15999998|NCT02889497|Biological|the third batch vaccine|
15999999|NCT02889484|Procedure|Lumbar disc hernia surgery|
16000000|NCT02889471|Procedure|ERCP with NB|ERCP with NB catheter for introperative tans-nasobiliary cholangiography
16000001|NCT02889471|Procedure|ERCP alone|ERCP alone followed with standard laparoscopic cholecystectomy
16000002|NCT02889458|Other|Not Provided|
16000003|NCT02889445|Drug|4-Demethyl-4-cholesteryloxycarbonylpenclomedine|IV administration as described
16000004|NCT02889432|Drug|Oral Melatonin 10mg|
16000005|NCT02889432|Drug|Placebo|
16000006|NCT02889419|Device|Evaluation of underwear Selfia®|Patients are evaluated for a week using their usual underwear for the realization of SC. At the end of the week, they receive Selfia ® adaptated underwear and they use it for one week for a new evaluation. Finally, underwear will be given to patients and during follow-up consultations in routine at 6 months and 1 year, he will be asked if they reused or bought underwear.
16000007|NCT02889406|Behavioral|Motivational intervention|motivational interviewing schema
16000008|NCT02889393|Drug|Teduglutide|Daily 0.05 mg/kg Teduglutide administered subcutaneously.
16000009|NCT02889393|Other|Standard of Care|The standard of care treatment of ECF which includes meticulous wound care, optimizations of nutrition, use of acid-suppression medications and anti-motility agents as per treating physician discretion.
16000010|NCT02889380|Drug|No Intervention|This study will retrospectively collect the data from the subjects who had been treated with 0.25 mg of Cetrotide injection daily in a fixed or flexible antagonist protocol with an available ART outcome.
16000011|NCT02889367|Drug|Odalasvir 100 mg|Participants will receive odalasvir 2*50 mg tablet, orally once on Day 1.
16000012|NCT02889367|Drug|Placebo|Participants will receive odalasvir matching placebo, tablet, orally once on Day 1.
16000013|NCT02889367|Drug|Odalasvir 500 mg|Participants will receive odalasvir 10*50 mg tablet, orally once on Day 1.
16000014|NCT02889367|Drug|Odalasvir (Up to maximum 1000 mg)|Participants will receive odalasvir to be decided up to maximum of 20*50 mg tablet, orally once on Day 1.
16000015|NCT02889354|Behavioral|Cognitive-behavioral therapy|
16000016|NCT02889341|Dietary Supplement|DHA|
16000017|NCT02889341|Other|Placebo|
16000018|NCT02889328|Drug|Regorafenib|Regorafenib 100mg continuous dosing arm
16000019|NCT02889302|Drug|KPS-0373|24 weeks
16000020|NCT02889302|Drug|Placebo|24 weeks
16000021|NCT02889289|Other|Xbox One Kinect Gaming|"The Veteran completed 15 sessions of supervised VR training. Each session lasted between 50 and 60 minutes in total. The intervention utilized 2 commercially available Xbox One Kinect games called Shape Up and Kinect Sports: Rivals to challenge both cardiovascular and balance systems. Each game is composed of mini-games (MG). Each MG lasted between 1:30 minutes to 4:00 minutes. Both games were played for approximately 25 minutes during each session. Rest breaks were allowed as the participant required them. Guarding by a therapist was provided dependent on the challenge of the game and the participant's abilities."
16000022|NCT02889276|Other|Functional Resistance Training|Supervised group-based Functional Resistance Training
16000023|NCT02889276|Behavioral|Unsupervised activity|General activity to meet 150 minutes of moderate intensity activity per week
16000024|NCT02889250|Device|Medtronic Activa SC DBS, Lead Model 3387|Deep Brain Stimulation
16000025|NCT02889237|Dietary Supplement|Calcium|Immediate administration of daily calcium supplementation for 12 weeks
16000026|NCT02889237|Dietary Supplement|Calcium + low dose vitamin D|Immediate administration of daily calcium and low dose vitamin D (1 sachet CaD 1000/880) supplementation for 12 weeks
16000027|NCT02889237|Dietary Supplement|Calcium + high dose vitamin D|Immediate administration of daily calcium and high dose vitamin D (2 sachets CaD 500/880) supplementation for 12 weeks
16000028|NCT02889224|Other|Obese|
16000029|NCT02889224|Procedure|Hypercortisolism|
16000030|NCT02889224|Other|Hydrocortisone|
16000031|NCT02889224|Other|Control|
16000032|NCT02889211|Behavioral|Gambling Task|
16000033|NCT02889198|Behavioral|Go NAP SACC|Go NAP SACC is a suite of online tools designed to help child care programs improve their nutrition environment. Tools include: self-assessment, goal setting, action planning, and tips and materials. In addition to these online tools, local technical assistance providers offer center directors an orientation on how to use Go NAP SACC and minimal ongoing technical assistance.
16000034|NCT02889185|Device|RTX1 IMAGIN EYE retinal camera|In addition to the routine examination including OCT, an imaging using RTX1 IMAGIN EYE retinal camera will be performed.
16000035|NCT02889172|Behavioral|Problem Solving Therapy|It will be apply a Brief Intervention (PST) for patients with Type II Diabetes Mellitus and Obesity who receive treatment in primary care centers from Mexico City to evaluate if PST improvement the depressive and anxiety symptoms and help to adhere to treatment and stabilize their metabolic variables
16000036|NCT02889159|Biological|Candida albicans antigen|0.1 milliliter (mL) injection into superficial dermis making small bleb at Baseline Visit.
16000037|NCT02889159|Biological|histamine phosphate|0.01 milliliter (mL) of histamine phosphate injected into the superficial dermis making a small bleb at Baseline Visit.
16000038|NCT02889159|Biological|imiquimod 5% cream|Pea sized amount of 5% cream to be applied to designated areas once daily for 4 days, beginning at Baseline Visit.
16000039|NCT02889159|Procedure|Tape Stripping|At Baseline Visit, adhesive tape firmly applied to designated area for 2 seconds, then removed. Procedure repeated between 20 and 50 times until skin is slightly red and tacky.
16000040|NCT02889146|Other|Conventional Physical Therapy|Control group will receive respiratory therapy according to the service routine and conventional physical therapy. Conventional physical therapy will be offered by the hospital physical therapists, according to their own criteria. Consists of passive, assisted and resisted mobilization, positioning in bed, transferring to bedside or chair, orthostatism and deambulation, however without a definition of a protocol. The physical therapist will be responsible for the choice of the techniques employed in each session. There will be no previous definition of the next sessions. No technology equipment will be used in this group, since they are not available in the routine care.
16000041|NCT02889146|Other|Early and progressive mobilization program|Protocol group will receive respiratory therapy according to the service routine and motor physical therapy according to the program of early and progressive mobilization. Patients will receive the program once daily during the intensive care unit stay, offered by a trained physical therapist, at the adequate level according to the level of consciousness and muscle strength. The program contains by techniques for muscle length and muscle strength maintenance or gain, aerobic exercises, exercises for gait rehabilitation and cognitive components. Patient will progress to the next level of the protocol completing the previous level. Technology equipment available: functional electrical stimulation device, dumbbells, cycle ergometer, fixed walker, ambulation assistive device and video game.
16000042|NCT02889146|Other|Respiratory therapy|Respiratory therapy according to the service routine.
16000630|NCT02884102|Genetic|genetic sequencing|
16000043|NCT02889133|Drug|Iron-dextran|Approved for clinical use: 1-gram dose IV - diluted in 500 mL, one pint normal saline.
16000044|NCT02889133|Drug|Saline|Salt water IV - 500 mL, one pint normal saline.
16000045|NCT02889133|Procedure|Blood Donation|Standard process of collecting and storing blood and blood components (approximately 450 mL, or a pint of blood). Following donation, the blood will be leukoreduced, packed, and stored in AS-3 solution.
16000046|NCT02889133|Procedure|24-hour PTR|"The way the FDA determines how good blood is for transfusion is called a radioactive 51-Chromium 24-hour post-transfusion red cell recovery study. The purpose is to measure how many of the transfused red cells are still in circulation (being pumped by the heart through blood vessels) 24 hours after transfusion. In order to measure the percent of red cells that are still in circulation, a small amount of the donated blood will be radioactively labeled. This will be infused in one arm and then blood will be collected from the other arm at different time points to measure how much of the transfused red cells are still in circulation."
16000047|NCT02889107|Other|personal frequency modulated systems|patients used personal frequency modulated systems for at least 4 hours daily for 10 weeks
16000048|NCT02889094|Other|Routine care|Routine care recommended for patients co-infected with HIV and hepatitis B virus (per European Association for the Study of the Liver and European AIDS Clinical Society guidelines).
16000049|NCT02889081|Other|maternal biological folate level|supplementation status and serum level
16000050|NCT02889081|Other|maternal biological Vitamin D level|supplementation status and serum level
16000051|NCT02889068|Other|Blood sample|
16000052|NCT02889055|Device|patient requiring the MIRUS (mechanical ventilation)|
16000053|NCT02889042|Other|MRI and biological assessment|performing a MRI and a biological assessment
16000054|NCT02889029|Device|new 3D device|dedicated tailored stents wrought by 3D computer-assisted conception
16000055|NCT02889003|Drug|Pioglitazone + TKI|
16000056|NCT02888990|Drug|Dasatinib|
16000057|NCT02888964|Drug|Add-on therapy|Pioglitazone therapy
16000058|NCT02888938|Other|pelvic radiography|
16000059|NCT02888938|Other|pelvic MRI|
16000060|NCT02888938|Other|pelvic CT-scan|
16000061|NCT02888925|Other|Mooney test|
16000062|NCT02888925|Other|Benton Face Recognition test|
16000063|NCT02888925|Other|Face inversion effect test|
16000064|NCT02888925|Other|Face composite effect test|
16000065|NCT02888925|Other|Cambridge Face Memory Test|
16000066|NCT02888925|Other|Matching different view test|
16000067|NCT02888925|Other|Memorizing and recognition of new faces test|
16000068|NCT02888925|Other|Memorizing and recognition of new objects test|
16000069|NCT02888925|Other|Recognition of celebrities and access to semantic information test|
16000070|NCT02888925|Procedure|Lobectomy|In patients with anterior temporal epilepsy, at 6 to 12 months after inclusion, depending on surgery decision taken after pre-surgery conventional intercritical assessment
16000071|NCT02888912|Other|EQUIA|Placing glass ionomer restorations, the dentin and enamel of cavities were conditioned with 20% polyacrylic acid for 20 seconds, washed, and briefly dried. Equia Fil was injected into the cavity. Isolation was maintained using cotton rolls and a saliva ejector. After the setting time of 2.5 minutes, the restoration was polished wet using high-speed fine diamonds. When the restoration was briefly dried, Equia Coat was applied and photocured for 20 seconds using a photo-curing light.
16000072|NCT02888912|Other|Gradia Direct Posterior|The enamel and dentin were conditioned with G-Bond adhesive using a microtip applicator, left undisturbed for five to 10 seconds, and then dried thoroughly for five seconds with oil-free air under air pressure, Gradia Direct Posterior resin was applied with the incremental technique (2 mm thick layers) and light-cured for 20 seconds. Finally, the restoration was shaped with finishing diamonds and silicon instruments.
16000073|NCT02888899|Behavioral|Biofeedback|
16000074|NCT02888899|Drug|Loperamide|
16000075|NCT02888899|Drug|Stool bulking agent (sterculia or ispaghula husk)|
16000076|NCT02888899|Other|PTNS|
16000077|NCT02888886|Other|Questionnaires about food habits and tobacco|
16000078|NCT02888886|Other|Spirometry|
16000079|NCT02888886|Other|Carotid echography|
16000080|NCT02888886|Other|Blood sample|for genetic polymorphism analysis, CRP, homocysteine and cytokine tests, glycemia and dyslipidemia analyses
16000081|NCT02888873|Other|Charisma|"The surfaces were etched using 35% phosphoric acid for 30 s. The etched surfaces were rinsed and dried. Charisma was used in combination Gluma2 Bond etch&rinse adhesive. The composite resin restorations were light-cured (600 milliwatt/cm²). Occlusion was checked with thin articulating papers.
~Restoration surfaces were finished and polished with fine finishing diamond burs, stones and rubber cups."
16000082|NCT02888873|Other|Charisma Classic|"The surfaces were etched using 35% phosphoric acid for 30 s. The etched surfaces were rinsed and dried. Charisma classic was used in combination Gluma2 Bond etch&rinse adhesive. The composite resin restorations were light-cured (600 milliwatt/cm²). Occlusion was checked with thin articulating papers.
~Restoration surfaces were finished and polished with fine finishing diamond burs, stones and rubber cups."
16000083|NCT02888847|Device|Philips Zoom! White Speed whitening lamp|bleaching protocol with descending built in light intensities
16000084|NCT02888847|Device|Philips Zoom! Advanced power whitening lamp|bleaching protocol with high light intensity
16000085|NCT02888834|Other|Adverse drug reaction|
16000086|NCT02888821|Behavioral|CLS-FUERTE|The CLS-FUERTE program is an approximately 6-week program and includes school (behavioral consultation with teachers), caretaker (caretaker skills groups), and student (skills groups) components which are integrated via joint teacher, parent, and student meetings and use of integrated behavioral programs in the classroom, on the playground, and at home.
16000087|NCT02888808|Other|Gastroscopy|Upper gastrointestinal endoscopy procedure
16000088|NCT02888795|Drug|hypertonic dextrose prolotherapy|five intra-articular injection at 2-weeks intervals in weeks 0, 2, 4, 6, 8.
16000089|NCT02888782|Other|Pharmacist Consultation|
16000118|NCT02888548|Procedure|orthosis (Saebo Strech°) + botulinum toxins (Dysport°) combined|orthosis (Saebo Strech°) + botulinum toxins (Dysport°) combined
16000119|NCT02888535|Other|Internal Medicine consultation|
16000120|NCT02888522|Biological|immunomodulation|Immunomodulation depending on chimerism
16000090|NCT02888769|Behavioral|Text Messaging|Patients will receive regular semi-personalized text messages for 6 months. Each participants will receive 6 text messages per week, which will be sent at random times of the day (9.00am, 12noon, 4.00pm). Non-smokers will receive two general messages, two hypertension messages, one medication adherence message and one physical activity message per week. Smokers will receive one general message, two hypertension messages, one medication adherence message, one physical activity message and one smoking cessation message per week. Prior to study commencement, a bank of 280 messages have been developed based on guidelines and behavior change theory (BCT), and have underwent multidisciplinary expert review and qualitative review process.
16000091|NCT02888756|Biological|iHIVARNA-01|Therapeutic vaccination, followed by treatment interruption
16000092|NCT02888756|Biological|TriMix|Therapeutic vaccination, followed by treatment interruption
16000093|NCT02888756|Biological|Placebo|Therapeutic vaccination, followed by treatment interruption
16000094|NCT02888743|Biological|Durvalumab|Given IV
16000095|NCT02888743|Radiation|Radiation Therapy|Undergo radiation therapy
16000096|NCT02888743|Biological|Tremelimumab|Given IV
16000097|NCT02888730|Drug|Tobramycin nebulized nasally|"Two sonic nebulizations per day will be realized by patients: morning and evening during 15 days. There should be a maximum of 12 hours between the 2 doses but shall not be less than 6 hours. The dosage should not be adjusted to body weight. All patients will receive one ampoule of tobramycin twice a dayAmpoules of tobramycin are filled by 5 ml containing 300 mg of tobramycin and 11.25 mg of sodium chloride. Bulb should be employed in nebulizer and administered by the inhalation route approximately 15 minutes to complete.Antibiotic retained for the study, tobramycin is manufactured by the Pharmacie à Usage Interne of the Henri Mondor Hospital. The study's product will be prepared with Base Tobramycin and excipients in accordance with TOBI's composition."
16000098|NCT02888730|Drug|Physiologic serum nebulized nasally|"Two sonic nebulizations per day will be realized by patients: morning and evening during 15 days. There should be a maximum of 12 hours between the 2 doses but shall not be less than 6 hours. The dosage should not be adjusted to body weight. All patients will receive one ampoule of placebo (Nacl 0.9%) twice a day.Ampoules of placebo are filled by 5 ml containing of sodium chloride. Bulb should be employed in nebulizer and administered by the inhalation route approximately 15 minutes to complete. Placebo for the study is manufactured by the Pharmacie à Usage Interne of the Henri Mondor Hospital. Patients in placebo arm will receive 5ml of sodium chloride with the same color (light yellow transparent) as tobramycin"
16000099|NCT02888717|Procedure|'OSNA stadification during surgery'|"The para-aortic dissection surgery is performed in the usual way. The lymph nodes are isolated from fat tissue during surgery, and cut into 4 slices sterile.
~Slices A and C are sent OSNA analysis
~Slices B and D are sent ultimately histological analysis (1 cup HES or 5 cup HES + IHC) The nodes of less than 5 mm will be sent in final histological analysis due to the inability to cut into 4.
~After the analysis, the report indicates whether the node is:
~Free (-): <250 copies
~Micrometastatic (+): 250 ≤ - <5,000 copies,
~Macrometastatic (++): ≥ 5000 copies."
16000100|NCT02888704|Drug|ADSTEM Inj. (Adult human mesenchymal stem cells)|Comparison of different dosages of the drug in the aspect of safety and efficacy.
16000101|NCT02888691|Other|Low carbohydrate diet|
16000102|NCT02888691|Other|High carbohydrate diet|
16000103|NCT02888678|Behavioral|Economic Strengthening (Impumelelo)|Economic Strengthening (Impumelelo): This intervention consists of 15 one-hour long sessions on financial education in combination with access to appropriate youth-friendly savings mechanisms.
16000104|NCT02888678|Behavioral|HIV Prevention Education (Vhutshilo 2.2)|HIV Prevention Education (Vhutshilo 2.2): This intervention consists of 15 one-hour long sessions that are interactive, skills focused, and cover such topics as expressing one's feelings; dealing with loss and grief; decision-making; coping; gender violence; understanding HIV and other sexually transmitted infections; healthy relationships and staying safe in sexual relationships; and contraception and risks associated with unplanned pregnancy.
16000105|NCT02888665|Drug|Doxorubicin Hydrochloride|Given IV
16000106|NCT02888665|Other|Laboratory Biomarker Analysis|Correlative studies
16000107|NCT02888665|Biological|Pembrolizumab|Given IV
16000108|NCT02888652|Drug|antiplatelet agents(Clopidogrel or Ticagrelor)|Clinical physicians according to patients condition to give different antiplatelet agents(Clopidogrel or Ticagrelor).We only observe clinical curative effect.
16000109|NCT02888613|Procedure|mini laparotomy|The patient will be positioned supine. After induction of general anesthesia, a median umbilical incision will be performed. The average length of the incision of the laparotomy will be 10 cm (8-12 cm). The small intestine will be then mobilized medially and held by an orthostatic retractor. Arterial dissection and control as well as bypasses will be performed according to the conventional technique. In case of occlusive disease of the iliac arteries, femoral site will be selected to achieve the distal anastomoses of the bifurcated prosthetic graft.
16000110|NCT02888613|Procedure|mini lumbotomy|"After induction of general anesthesia, the patient will be positioned in right lateral decubitus at 45° of the table plane. The incision will be performed from the tip of the eleventh rib with a slightly sloping path to the outer edge of the rectus muscle. The average length of the incision of the laparotomy will be 10 cm (8-12 cm).
~Abdominal aorta will be approached retroperitoneally. Arterial dissection and control as well as bypasses will be performed according to the conventional retroperitoneal technique. In case of occlusive disease of the iliac arteries, femoral site will be selected to achieve the distal anastomoses of the bifurcated prosthetic graft."
16000111|NCT02888600|Behavioral|Mindfulness Training|Guided mindfulness meditation and stress management training
16000112|NCT02888600|Behavioral|Health Education|Guided health education and stress management training
16000113|NCT02888574|Drug|Intranasal Oxytocin|Intranasal oxytocin (Syntocinon; Novartis, Switzerland)
16000114|NCT02888574|Drug|Placebo|Placebo nasal spray
16000115|NCT02888561|Drug|Dobutamine|Dobutamine will be infused at the time of coronary angiography while coronary and LV haemodynamics are measured using a Combowire (dual pressure and flow sensor tip guide wire) and left ventricular conductance catheter.
16000116|NCT02888561|Drug|Nitrite|Nitrite will be infused at the time of coronary angiography while coronary and LV haemodynamics are measured using a Combowire (dual pressure and flow sensor tip guide wire) and left ventricular conductance catheter.
16000117|NCT02888548|Procedure|botulinum toxins (Dysport°) alone|botulinum toxins (Dysport°) alone
16000121|NCT02888496|Drug|tocilizumab|3 monthly IV infusions in PMR patients
16000124|NCT02888444|Behavioral|Behavioural support|Consisting of the study-specific doctor delivering relapse prevention orientated behavioural support at the time of consultation, plus six 10-15 minute calls over the 12 weeks delivered by a research assistant.
16000125|NCT02888444|Drug|Placebo|Two 0.5mg tablets taken twice daily
16000126|NCT02888431|Device|bedside point-of-care device|A bedside point-of-care device is routinely used in the operating room to measure lactate, base deficit, and pH.
16000127|NCT02888418|Biological|Tetravalent recombinant human papilloma virus vaccine (6,11,16,18 type) (Hansenula polymorpha)|Injection vaccine produced by Beijing institute of biological products co., LTD, containing HPV antigen protein, 120μg/0.5ml/bottle
16000128|NCT02888418|Biological|placebo|
16000129|NCT02888405|Other|High-carbohydrate diet|
16000130|NCT02888405|Other|Low-carbohydrate diet|
16000131|NCT02888392|Other|Kiwifruit|2 green kiwifruit cultivar 'Hayward'
16000132|NCT02888392|Dietary Supplement|Psyllium|Pysllium seed husk; ispaghula, isabgol, or psyllium, are portions of the seeds of the plant Plantago ovata, (genus Plantago), a native of India, Bangladesh and Pakistan. They are hygroscopic, which allows them to expand and become mucilaginous. Psyllium is a faecal bulking agent used to treat constipation. It absorbs liquid in the intestines, swells and forms a bulky soft stool that is easy to pass
16000133|NCT02888379|Drug|TOP1288|
16000134|NCT02888379|Drug|Placebo (for TOP1288)|
16000135|NCT02888353|Device|Device: MRI|Perform MRI in patients with cardiac devices
16000136|NCT02888340|Other|Acupuncture|Acupuncture involves inserting thin, sterile needles into the skin. The needles do not go into the skin very far. Number of acupuncture sessions: one.
16000137|NCT02888327|Drug|AL-794|
16000138|NCT02888327|Drug|Oseltamivir|
16000139|NCT02888327|Drug|Digoxin|
16000140|NCT02888327|Drug|Midazolam|
16000141|NCT02888327|Drug|Pitavastatin|
16000142|NCT02888327|Drug|JNJ-63623872|
16000143|NCT02888301|Procedure|Computed Tomography|Undergo 18F-clofarabine PET/CT
16000144|NCT02888301|Radiation|Fluorine F 18 Clofarabine|Given IV
16000145|NCT02888301|Procedure|Positron Emission Tomography|Undergo 18F-clofarabine PET/CT
16000146|NCT02888288|Behavioral|Mental Health Intervention|Includes a standard format of greetings, review of last session content, homework discussion, new topic, assigning homework and ends with a fun activity, relaxation or game. First session is a joint session with youth and caregivers. Topics include common stresses and worries experienced by HIV+ youth; relaxation and coping techniques; cognitive behavioral triangle; story of finding out HIV status and if willing, to discuss this in an individual session, peer group session, and with caregiver; identify circles of support; discuss stigma and how to disclose HIV status to others; consider values, hopes and dreams for the future, and how to use this information to live positively with HIV. ART adherence is woven into case examples and discussions.
16000147|NCT02888288|Behavioral|Standard of Care|Standard of Care includes enhanced ART adherence based on clinic protocols and monthly HIV teaching sessions prior to adolescent clinic.
16000148|NCT02888275|Drug|Dexmedetomidine|
16000149|NCT02888275|Drug|normal saline|
16000150|NCT02888249|Other|Altered composition cigarette|This double-blind study will systematically determine the abuse liability of altered composition cigarettes using a behavioral economics abuse-liability approach. Altered composition cigarettes (e.g., cigarettes differing in casings, sugars, tar levels, moisture) may result in decreased intake and decreased dependence, although critical questions remain regarding the abuse-liability of altered composition cigarettes, whether exposure to these cigarettes reduces use, and whether altered composition cigarettes will substitute for standard cigarettes. The addictive effects and abuse liability of altered composition cigarettes, therefore, are not well understood, and will be tested in this study.
16000151|NCT02888236|Drug|LEO 32731|
16000152|NCT02888236|Drug|LEO 32731 Placebo|
16000153|NCT02888223|Biological|SCT800|
16000154|NCT02888223|Biological|Xyntha|
16000155|NCT02888210|Device|MD-15 Intraocular Lens|
16000156|NCT02888171|Drug|ferric citrate|Participants randomized to the ferric citrate arm will take 2 grams of ferric citrate three times a day with meals.
16000157|NCT02888171|Drug|ferrous sulfate|Participants randomized to the ferrous sulfate arm will take 325 mg of ferrous sulfate three times a day.
16000158|NCT02888158|Other|Robotic assistance|Robotic assistance will be implemented during Pelvic Trainer training sessions.
16000159|NCT02888158|Other|Pelvic Trainer|The standard Pelvic Trainer simulator for surgical training.
16000160|NCT02888132|Procedure|Echocardiography-guided transthoracic radio frequency ablation for HOCM ventricular septum|
16000161|NCT02888132|Procedure|Echocardiography-guided transthoracic laser ablation for HOCM ventricular septum|
16000162|NCT02888119|Device|PRISMA 3T MRI scanner (Siemens Medical Solutions)|A baseline MRI exam consisting of accelerated 3D-T1p, and T2, MRI will be performed. Longitudinal follow-up MRI exams (24 months) will be repeated on the same knee on all OA patients.
16000163|NCT02888106|Drug|Myrcludex B|Lyophilised powder for solution for subcutaneous injection
16000164|NCT02888106|Drug|PEG IFN alfa-2a|solution for subcutaneous injection, once per week
16000165|NCT02888106|Drug|Tenofovir|Film-coated tablets, 300 mg, per os, once daily
16000166|NCT02888093|Device|Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)|
16000167|NCT02888080|Drug|ACZ885|ACZ885 will be administered subcutaneously to assigned study subjects once monthly for 6 months.
16000168|NCT02888080|Drug|Placebo|Placebo will be administered subcutaneously to assigned study subjects once monthly for 6 months.
16000169|NCT02888067|Drug|Rocuronium bromide 0.5 mg/kg|Moderate neuromuscular blockade with rocuronium bromide
16000170|NCT02888067|Drug|Rocuronium bromide 1.0 mg/kg|Deep neuromuscular blockade with rocuronium bromide
16000171|NCT02888067|Drug|Sugammadex sodium 2 mg/kg|Reversal with sugammadex sodium
16000172|NCT02888067|Drug|Sugammadex sodium 4 mg/kg|Reversal with sugammadex sodium
16000173|NCT02888054|Drug|lesinurad/allopurinol 200/300 FDC tablet|
16000174|NCT02888054|Drug|lesinurad 200 mg|
16000175|NCT02888054|Drug|allopurinol 300 mg|
16000203|NCT02887768|Procedure|Coronary Artery Bypass Grafting Surgery|All participants will undergo standard coronary artery bypass grafting surgery to treat coronary artery disease
16071124|NCT02374567|Drug|Chloral Hydrate|
16000176|NCT02888041|Drug|Dinoprostone|In case of failure of cervical ripening after a first intravaginal delivery device of Dinoprostone (Propess® 10 mg), patients receive a second Propess®, followed by Oxytocin 5U.I/ml (Syntocinon®) (if necessary) and epidural analgesia if desired by the patient.
16000177|NCT02888041|Drug|Oxytocine|In case of failure of cervical ripening after a first intravaginal delivery device of Dinoprostone (Propess® 10mg), patients receive directly Oxytocin 5U.I/ml (Syntocinon®) and epidural analgesia if desired by the patient.
16000178|NCT02888028|Procedure|ICD remote monitoring|ICD remote monitoring additionally to regular in-office visits
16000179|NCT02888028|Other|Control group|Regular in-office visits/FU 1,3,6 and 12 months post implantation of an ICD or post ICD replacement w/o remote FU
16000180|NCT02888015|Other|upper extremity exercise program|five exercises to improve upper extremity strength and endurance will be provided to patients, shoulder flexion, abduction/adduction, elbow flexion/extension, internal/external rotation
16000181|NCT02888002|Behavioral|Guide to better alcohol habits|A 5-module therapeutic program wich includes self-help material in printed or web-based form with interactive exercises. The program includes instructions for the therapist.
16000182|NCT02887989|Device|Virtual Reality|A menu of VR experiences, lasting from 3-30 minutes each. For example, patients may watch a soothing virtual campfire, or fly over a scenic landscape, or play an interactive game.
16000183|NCT02887989|Device|Health and Wellness Channel|Relaxing content broadcast passively on the patient in-room television channel.
16000184|NCT02887976|Drug|SoluMatrix™ Abiraterone Acetate|SoluMatrix™ Abiraterone Acetate 500mg (4 x 125 mg qd) is an androgen synthesis inhibitor
16000185|NCT02887976|Drug|Methylprednisolone|Methylprednisolone (4mg bid) to maintain physiologic levels of corticosteroids which are reduced by SoluMatrix Abiraterone Acetate
16000186|NCT02887950|Other|Nutritional counseling|Nutritional counseling consists in: personalized dietary prescription associated with dietetic advise (on a monthly basis and upon patient's request) by a registered dietician.
16000187|NCT02887950|Dietary Supplement|Equikilon-3 months|"The patient will receive 2 sachets per day of a dietary supplement containing resistant starch, epigallocatechin gallate and chlorogenic acid (Equikilon) for 3 months and nutritional counseling.
~Nutritional counseling consists in: personalized dietary prescription associated with dietetic advise (on a monthly basis and upon patient's request) by a registered dietician."
16000188|NCT02887950|Dietary Supplement|Equikilon-6 months|"The patient will receive 2 sachets per day of a dietary supplement containing resistant starch, epigallocatechin gallate and chlorogenic acid (Equikilon) for 6 months and nutritional counseling.
~Nutritional counseling consists in: personalized dietary prescription associated with dietetic advise (on a monthly basis and upon patient's request) by a registered dietician."
16000189|NCT02887937|Drug|Definity|The contrast agent, Definity, 10 µL/kg, will be administered through an intravenous catheter placed in an antecubital vein. Definity is an FDA approved contrast agent for cardiac studies and will be an off-label use in this study. The agent will be injected as a single intravenous bolus followed by a 10 mL saline flush (0.9% NaCl). Images will be recorded with clip function for 90 seconds following the administration of contrast while the probe is stabilized and minimal pressure applied. During this time, qualitative evaluation of tumor enhancement will be observed, and the presence of contrast uptake within the tumor will be categorized.
16000190|NCT02887924|Device|Neopuff; Fisher and Paykel, Auckland, New Zealand|Following the oral and nasal aspirates, SLI at 25 cm H2O pressure will be applied for 15 seconds by using t-piece refreshing and binasal prongs and 5-cm nCPAP at H2O pressure will be applied.
16000191|NCT02887898|Device|Automated bolus calculator|
16000192|NCT02887898|Other|Education|
16000193|NCT02887885|Drug|Gynoflor|1 vaginal tablet daily for 12 days, followed by 3 vaginal tablets per week as maintenance therapy (Monday-Wednesday-Friday) for 6 weeks
16000194|NCT02887872|Other|Electrical stimulation-dynamic hand orthosis|Each participant participated in the electrical stimulation-dynamic hand orthosis regimen. Repetitive grasp/release motions were performed for 30 minutes while wearing the dynamic hand orthosis. This was followed by 15 minutes of electrical stimulation applied to forearm extensor muscles. This regimen was performed daily, 5X/week for 6 weeks.
16000195|NCT02887859|Biological|Human Acellular Vessel (HAV)|Patients will be implanted with a Human Acellular Vessel (HAV) as a femoro-popliteal bypass conduit using standard vascular surgical techniques
16000196|NCT02887846|Device|Heated Humidified High-Flow Nasal Cannula|Patients requiring mechanical ventilation for at least 6 hours on the first 7 postnatal days will be included in the study.When patients were Fi O2 < 0,40, Pa CO2 < 65 mmHg, pH> 7.20, MAP (mean airway pressure) <7 cm H2O, they will be extubated if statistically stable.Oxygen-air mixture of 4-6 l / min flow rate will be set in HHHFNC group, and pressure will be set to 5-8 cm H2O in NCPAP group. When flow is 2 l / min, FiO2 is<0.30 at 24 hours and above, free oxygen will be introduced. In NCPAP group, when pressure is 5 cm H2O and FiO2 < 0.30 at 24 hours and above, free oxygen will be introduced.
16000197|NCT02887833|Other|Clinical biomarker (thermal sensory testing)|Thermal sensitivity testing: The area of CIBP and a corresponding unaffected (control) area will be assessed using warm and cool thermal rollers (Rolltemp, Somedic, Sweden). The control area will either be the contralateral side, or an area proximal to the affected site.
16000198|NCT02887820|Device|Thromboelastograph|A thromboelastograph flowchart will be followed in addition to traditional laboratory tests to manage blood transfusion and coagulation decisions
16000199|NCT02887807|Drug|Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation|cardio-pulmonary resuscitation usual care of cardiac arrest
16000200|NCT02887807|Drug|Single intravenous bolus of placebo at the onset of resuscitation|cardio-pulmonary resuscitation usual care of cardiac arrest
16000201|NCT02887794|Other|Clinical and psychoacoustic measures|Our study focuses on psychoacoustic tests, specialist care protocols (psychotherapy, neuromodulation ...) being made independently of our study, as part of medical activity of Cerletti care unit or differentiated protocols. Thus, our study shows no individual benefit for the patient. However, a better understanding of the neurophysiological mechanisms underlying auditory hallucinatory phenomenon could allow a better management of these patients in the near future
16000202|NCT02887768|Device|Epicardial Infarct Repair with CorMatrix-ECM|CorMatrix-ECM-biomaterial will be surgically applied to the epicardial surface of the infarct myocardium at the time of coronary artery bypass surgery
16000256|NCT02887313|Radiation|Radiotherapy|Patietns received preoperative radiotherapy, 1.8-2.0GY/23-25F
16000204|NCT02887755|Device|Near-Infrared Spectroscopy (NIRS) Sensor|These sensors utilize NIRS to evaluate oxygenated and deoxygenated hemoglobin, total oxygenation index and total blood flow. This is done by bouncing infrared light off of chromatophores (located within red blood cells), which is then refracted off of the cells in the capillary beds to the topical sensor.
16000205|NCT02887703|Behavioral|Sensory Augmentation|Sensory augmentation is a technique of augmenting or replacing compromised sensory information. In the context of sensory-based balance impairments, a sensory augmentation device provides cues of body motion that supplement an individual's remaining intact sensory systems.
16000206|NCT02887690|Device|Modular Prosthetic Limb|
16000207|NCT02887677|Drug|Dapagliflozin|Administration of dapagliflozin (film-coated tablet of 10mg, per os, q24h, 12 weeks)
16000208|NCT02887677|Drug|Placebo|Administration of placebo (film-coated tablet of same color and texture with dapagliflozin, 10mg, per os, q24h, 12 weeks).
16000209|NCT02887664|Procedure|Blood test|Blood will be drawn from mother's vein and from the cord to test for n-6:n-3 ratio and inflammatory markers: CRP, IL-6, TPO and TNF-alpha markers
16000210|NCT02887651|Radiation|Cavity boost radiation|Cavity boost radiation therapy with 10 x 3 Gy for patients suffering from complete resected cerebral metastases
16000211|NCT02887638|Other|Individual Profile Analysis (Physical therapy Intervention)|"The Individual Profile Analysis consists of the following components:
~Analysis of the sitting-posture profile:
~o cervical spine, thoracic spine, lumbar spine and pelvis during a longitudinal provoking task (working at a laptop).
~Analysis of the dural profile before and after the provoking task:
~o Determination of the dural sensitivity by the use of the slump-test
~Analysis of the pain profile before and after the provoking task:
~Determination of pressure pain sensitivity by the use of pressure algometry
~Determination of the influence of pain on the quality of life by the use of the HIT-6 questionnaire"
16000212|NCT02887625|Drug|Pioglitazone plus exenatide|pioglitazone will be started at 30 mg/day and bydureon at 2 mg/week
16000213|NCT02887625|Drug|insulin glargine and insulin aspart|the dose will be escalated to maintain HbA1c <7.0%
16000214|NCT02887612|Other|ctDNA test|
16000215|NCT02887599|Procedure|Blood collection|1ml of blood specimen collection
16000216|NCT02887586|Other|auricular needling|Patients will be treated with auricular needling for 4 weeks. 4-8 specific auricular acupoints are selected unilaterally at a time, and alternate to another side every 2-3 days, treatment will last for 4 consecutive weeks. The following 4 ear acupoints points will be selected for every patient: Ear Shenmen, Stoma, Spleen, and Subcortex. Other ear acupoints including Triple Energizer, Liver, Sympathetic Nerve and Smallintestine will be selected based on the condition of patients. Treatment will be performed by a registered Chinese medicine practitioner.
16000217|NCT02887573|Drug|Free-residue nutrients|This trial evaluated the efficiency of free-residue nutrients for the bowel prepartion of CCE.
16000218|NCT02887573|Drug|Low fiber diet|Low fiber diet often used in the bowel prepartion of CCE. In this study, it is the control group.
16000219|NCT02887573|Procedure|Colon capsule endoscopy|In the study,all patients should undergo two colonoscopies.The first is for examinations and the second for therapy.
16000220|NCT02887573|Drug|2L PEG|2L PEG are laxatives for experiment group.
16000221|NCT02887573|Drug|4L PEG|4L PEG are laxatives in the control group.
16000222|NCT02887573|Drug|PEG|These PEG are for boosters. All patients will take 0.75L and 0.5L PEG for two boosters.
16000223|NCT02887573|Drug|Mosapride citrate|5mg mosapride citrate are used to promote gastric motivity.
16000224|NCT02887560|Procedure|transoesophageal echocardiography|
16000225|NCT02887547|Procedure|micro-osteoperforation|
16000226|NCT02887534|Drug|SPARC1401-low dose|SPARC1401- low dose
16000227|NCT02887534|Drug|SPARC1401-mid dose|SPARC1401- mid dose
16000228|NCT02887534|Drug|SPARC1401-high dose|SPARC1401-high dose
16000229|NCT02887534|Drug|Reference1401 (Tizanidine)|Reference1401 (Tizanidine) three times a day
16000230|NCT02887534|Drug|Placebo1401|Placebo
16000231|NCT02887521|Other|education|pulmonary rehabilitation participant manual
16000232|NCT02887521|Procedure|rehabilitation|pulmonary rehabilitation
16000233|NCT02887521|Device|pedometer|receive a pedometer
16000234|NCT02887521|Other|education|receive a pamphlet with exercises plus the standard course of care
16000235|NCT02887521|Procedure|surgery|patients undergo surgery
16000236|NCT02887508|Behavioral|HINTS Intervention|HINTS is a four-session, group-based behavioral intervention delivered exclusively online and developed using the IMB model of health behavior change focused on sexual risk reduction.
16000237|NCT02887508|Behavioral|Healthy Living Control|The Healthy Living Control is a four-session, group-based behavioral intervention delivered exclusively online and developed using the IMB model of health behavior change focused on non-sexual health topics.
16000238|NCT02887482|Biological|GLS-5700|GLS 5700 at 2 mg DNA/dose
16000239|NCT02887482|Biological|Placebo|
16000240|NCT02887469|Drug|3% hypertonic saline|The same as above
16000241|NCT02887456|Drug|Endodontic treatment using Vitapex|Endodontic treatment using Vitapex
16000242|NCT02887456|Drug|Endodontic treatment using MTA paste|Endodontic treatment using MTA paste
16000243|NCT02887443|Drug|Raxone (idebenone 150 mg)|Raxone (idebenone 300 mg t.i.d.) on days 3 and days 5 to 10
16000244|NCT02887443|Drug|Midazolam 2,5 mg|Midazolam (2,5 mg single oral dose) on days 1, 3 and 10
16000245|NCT02887430|Other|foot reflexology therapy|standard care and foot reflexology
16000246|NCT02887404|Other|Spine surgery analgesic pathway|Enhanced pain management care
16000247|NCT02887404|Other|Usual Care|Standard of pain management care
16000248|NCT02887391|Other|No intervention - observational study|No intervention - observational study
16000249|NCT02887378|Device|hot clamps|reusable hot biopsy forceps
16000250|NCT02887378|Device|normal clamps|
16000251|NCT02887365|Drug|tegafur-uracil|
16000252|NCT02887352|Other|assessment of problem-solving ability|
16000253|NCT02887339|Other|Training Website|Additional training website can be found at gtextraing.org
16000254|NCT02887339|Other|Control|Standard training given by OPOs and GTEx staff
16000255|NCT02887313|Drug|mFOLFOX6|Patients receive mFOLFOX6 for 4 cycles during neoadjuvant radiotherapy, and after CRT, another 4 cycles of mFOLFOX6 would be given before surgery.
16000257|NCT02887300|Behavioral|Mantra Meditation|"Week 1:
~20 minute meditation session. Prescribed text discussion. Encouraging a daily practice; the log, daily readings, timer etc.
~Week 2:
~Review of the practice followed by a 20 minute meditation period. Challenges to learning meditation. Second 20 minute meditation. Discussion of prescribed text.
~Week 3:
~20 minute meditation. Review of Atul Gawande's lecture. Second 20 minute period of meditation. Discussion of prescribed text.
~Week 4:
~20 minute meditation session. Discussion of prescribed text. A second 20 minute meditation. End of programme review."
16000258|NCT02887287|Drug|EEN|
16000259|NCT02887261|Device|"BardPowerPort sip Implantable Port"|capable for power injection for contrast media.
16000260|NCT02887261|Device|Conventional Port|not for power injection for contrast media.
16000261|NCT02887248|Drug|nab-paclitaxel|"Induction: 125 mg/m² by intravenous (IV) infusion on Days 1 and 8 of each 21-day cycle for 3 to 6 cycles to be given with Gemcitabine.
~Maintenance: single agent nab-paclitaxel (260 mg/m²) by IV infusion every 21 days) until disease progression, intolerable toxicity or patient decision to discontinue treatment."
16000262|NCT02887248|Drug|Gemcitabine|Induction: 1000 mg/m²) by IV infusion on Days 1 and 8 of each 21-day cycle for 3 to 6 cycles.
16000263|NCT02887235|Other|Home Delivered, Medically Tailored Meals (HDTM)|
16000264|NCT02887222|Drug|Bupivacaine|0.0625% Bupivacaine plus fentanyl 2mcg/ml
16000265|NCT02887209|Behavioral|CBT-I|"Cognitive behavioural therapy for insomnia (CBT-I; Edinger & Carney, 2008) is a standard 4-session cognitive behavioural therapy for insomnia administered biweekly in individual format. The first session involves presenting treatment rationale and introducing a behavioural treatment regimen consisting of a series of sleep habit parameters to follow, and determining a personalized time in bed prescription. The second session involves reviewing past-week sleep diary, discussing the role of cognitions in insomnia, and discussing constructive worrying techniques and the use of thought records. The third and fourth sessions are used to assist in adjusting time in bed prescriptions, to positively reinforce efforts, and to help problem-solve any problems they might have encountered."
16000266|NCT02887183|Drug|LCZ696 (sacubitril/valsartan)|LCZ696 (sacubitril/valsartan) was supplied as unscored, ovaloid, film-coated oral tablets in the strengths of 24/26 mg, 49/51 mg, 97/103 mg to be taken twice daily (bid)
16000267|NCT02887157|Device|Swept Source OCT|The swept source optical coherence tomography device was developed at Duke University as the result of collaboration between the Departments of Ophthalmology and Biomedical Engineering. The SSOCT system has a 100kHz repetition rate, 1050nm-centered swept-source light source (Axsun Technologies). This swept-source system allows near real-time OCT imaging during movement while imaging and it provides better OCT imaging of the choroid. The SSOCT system is a non-contact device and therefore does not touch the eye.
16000268|NCT02887157|Other|Magnetic Resonance Imaging|Non-sedated research brain MRI: Magnetic resonance imaging (MRI) is a minimal risk procedure that uses a magnet and radio waves to make diagnostic medical images of the body. There have been no ill effects reported from exposure to the magnetism or radio waves used in this test. However, it is possible that harmful effects could be recognized in the future. A known risk is that the magnet could attract certain kinds of metal. Therefore, we will carefully ask about metal within the body. If there is any question about potentially hazardous metal within the body, MRI imaging will not be performed. We will also keep the examining room locked so that no one carrying metal objects can enter while the child is in the scanner.
16000269|NCT02887157|Other|Scavenged blood collection|Serum/plasma (residual in the laboratory) collected as part of clinically indicated care will be shipped to the University of Florida for neuroinflammatory biomarker testing to identify central nervous system cellular injury.
16000270|NCT02887144|Device|SenSura|SenSura is a Commercial and CE-marked ostomy product (1pc) manufactured by Coloplast A/S
16000271|NCT02887144|Device|SenSura test product|SenSura test product is a CE-marked ostomy product (1pc) manufactured by Coloplast A/S
16000272|NCT02887131|Other|Dynamic CT of the ankle|during inversion and eversion mouvement, with Aquilion One Toshiba scanner
16000273|NCT02887105|Other|Standard neuropsychological assessment|
16000274|NCT02887105|Other|Brain MRI|
16000275|NCT02887053|Device|MRI|
16000276|NCT02887040|Radiation|Radiation|Subjects ≥ 3 years of age with a diffuse, intrinsic brain stem glioma will receive radiation.
16000277|NCT02887040|Drug|Atengenal|Subjects ≥ 3 years of age with a diffuse, intrinsic brain stem glioma will receive Atengenal in combination with Astugenal (Antineoplaston therapy) and radiation
16000278|NCT02887040|Drug|Astugenal|Subjects ≥ 3 years of age with a diffuse, intrinsic brain stem glioma will receive Astugenal in combination with Atengenal (Antineoplaston therapy) and radiation
16000279|NCT02887027|Behavioral|Exercise4Mood Intervention|The Exercise4Mood Intervention was designed based on principles from the Exercise for Mood and Anxiety protocol (Smits et al., 2009) and consists primarily of a mobile application called Exercise4Mood. It will be supported by text-messages, delivered through SymTrend, reminding participants about their scheduled exercise sessions and prompting them to engage with the app. Its core features include: motivational tips to encourage exercise, reminders about scheduled exercise, tracking of exercise behavior, tracking of mood before, during, and after exercise, and post-exercise positive reinforcement statements.
16000280|NCT02887014|Procedure|SPECIFIC VERBAL INSTRUCTIONS|Participants will be randomized either to get detailed instructions verbally by the medico-paramedical staff of the participating centers (physicians or nurses) before starting bowel preparation (Group A) or to get ordinary instructions as usual in each of the participating centers (Group B). Instructions provided to Group A will include details about the procedure of bowel preparation, its potential side effects and the importance of the adequate preparation (Appendix)
16000281|NCT02887001|Other|Pharmacist consultation|
16000282|NCT02886988|Drug|Botulinum toxin type A|50 units of botulinum toxin diluted in 1 ml of normal saline will be administered. 0.1mlof BTA will be injected with a 30G needle.
16000283|NCT02886988|Drug|normal saline|0.1mlof normal saline will be injected with a 30G needle.
16000284|NCT02886975|Behavioral|low protein diet plus α-keto acid|0.4-0.6g of proteins per kilo of body weight per day, supplemented with α-keto acid tablets
16000285|NCT02886962|Biological|No oral anticoagulation|No oral anticoagulation, and no monitoring of the INR.
16000334|NCT02886546|Procedure|pneumoperitoneum|
16000335|NCT02886546|Device|oesophageal Doppler monitor|
16000336|NCT02886533|Other|Antithrombotic|Collection of clinical, biological data
16000286|NCT02886962|Drug|Oral anticoagulation with vitamin K antagonists|"Vitamin K antagonist prescription with INR target between 2 and 3 as recommended in the guidelines.
~Administration once daily or at the end of each dialysis session, according to the nephrologist choice.
~INR monitoring at least once per week"
16000287|NCT02886936|Device|iFIT Prosthesis|Transtibial and transfemoral amputee volunteers will be fit with the iFIT device and instructed on its use. Patient will wear the iFIT device for a two week time period according to a provided wear schedule. At the end of this time patient will rate it for comfort, stability and ease of use.
16000288|NCT02886923|Device|Hioxifilcon A Test|contact lens made with hioxifilcon A material
16000289|NCT02886923|Device|Hioxifilcon A With Cosmetic Ring Control|contact lens made with hioxifilcon A material with a cosmetic ring on the lens
16000290|NCT02886910|Other|Clinical observation|Antibiotics will be started only if sepsis-related signs or symptoms are present.Clinical observation consists in a standardized physical examination protocol according to which newborns are observed by the nurses at 1, 2, 4, 8, 12, 16, 20, 24 hours of life and then every 6 hours up to 48 hours of life. The following signs and symptoms are checked: skin colour (pink/pale/cyanotic/mottled), respiratory rate (lower or higher than 60 breaths/minute) and presence or absence of respiratory distress.
16000291|NCT02886910|Other|Standard management|Antibiotics will be started at birth. Clinical observation will be carried out with the same timing and protocol
16000292|NCT02886897|Biological|D-CIK and anti-PD-1 antibody|Autologous dendritic and cytokine-induced killer cells (D-CIK)(1.0-1.5*10^10 cells)were incubated with anti-PD-1 antibody and infused into participants.
16000293|NCT02886884|Drug|20 million Allogeneic Mesenchymal Human Stem Cells|1 single intravenous infusion
16000294|NCT02886884|Drug|100 million Allogeneic Mesenchymal Human Stem Cells|1 single intravenous infusion
16000295|NCT02886871|Behavioral|Step Goal Delivery by Smartphone|
16000296|NCT02886858|Device|Device : Transcranial direct current stimulation|The anode will be applied over the F3 area and the cathode over the F4 area. The current dose is 2mA. Electrodes will be 7x5cm in size. The investigators will apply 2 daily, tDCS sessions of 30 minutes, weekly the first month, fortnightly the second and third month, monthly the following 3 months.
16000297|NCT02886858|Device|Device : sham Transcranial direct current stimulation|The anode will be applied over the F3 area and the cathode over the F4 area. Electrodes will be 7x5cm in size. The investigators will apply 2 daily, tDCS sessions of 30 minutes, weekly the first month, fortnightly the second and third month, monthly the following 3 months.
16000298|NCT02886845|Genetic|rs183489969,rs185670819|compare the frequency of two germline mutations in breast cancers and controls
16000299|NCT02886832|Dietary Supplement|Prostate Health formulation|
16000300|NCT02886819|Other|vibration|Whole body vibration
16000301|NCT02886806|Other|BIS XP, Covidien, Ireland|Closed loop for propofol and remifentanil using BIS XP TM, Covidien, Ireland
16000302|NCT02886806|Other|EV-1000 TM, Edwards Lifesciences, Irvine, California, USA|Closed loop for fluid perfusion using EV-1000 TM, Edwards Lifesciences, Irvine, CA, USA
16000303|NCT02886793|Drug|fludeoxyglucose|
16000304|NCT02886780|Behavioral|Concentrated exposure treatment (cET)|Psychological cognitive behavioral treatment
16000305|NCT02886780|Behavioral|Self-help|
16000306|NCT02886767|Other|skin to skin contact|The researchers facilitated initial SSC between intervention-group participants and their infants within 24 hours of birthing under conditions that did not adversely affect spontaneous mother-infant SSC nor interfere with the early initiation of breastfeeding. Because it is standard practice to discharge vaginal-birth mothers on the third postpartum day, this study implemented the intervention during the first three postpartum days for both vaginal and cesarean birth cases.
16000307|NCT02886754|Behavioral|Proficiency-based progression|Use of validated metrics and performance benchmarks to simulation training
16000308|NCT02886754|Behavioral|National e-learning programme only|National e-learning programme (COMPASS)
16000309|NCT02886754|Behavioral|Standard simulation|Paper based simulation cases
16000310|NCT02886741|Other|Quality Improvement Campaign|"How To Guide addressed development of a QI plan; small-scale tests of change- (PDSA cycles) to refine implementation approaches through iterative learning; and reliance on multi-disciplinary implementation teams. IHI recruited relevant professional organizations to identify faculty."
16000311|NCT02886728|Drug|Filgotinib|Tablet(s) administered orally once daily
16000312|NCT02886728|Drug|Placebo to match filgotinib|Tablet(s) administered orally once daily
16000313|NCT02886728|Drug|MTX|Capsule(s) administered orally once weekly
16000314|NCT02886728|Drug|Placebo to match MTX|Capsule(s) administered orally once weekly
16000315|NCT02886715|Drug|Tazarotene Cream 0.1%|Tazarotene Cream 0.1% applied to cover the affected areas of the face once daily for 84 +/- 4 days.
16000316|NCT02886715|Drug|Tazorac®|Tazorac® applied to cover the affected areas of the face once daily for 84 +/- 4 days.
16000317|NCT02886715|Drug|Placebo|Placebo (vehicle of the test product) applied to cover the affected areas of the face once daily for 84 +/- 4 days.
16000318|NCT02886702|Drug|Tazarotene Cream 0.05%|Tazarotene Cream 0.05% to cover only the lesions with a thin film.
16000319|NCT02886702|Drug|TAZORAC® (tazarotene) Cream 0.05%|TAZORAC® (tazarotene) Cream 0.05% to cover only the lesions with a thin film.
16000320|NCT02886702|Drug|Placebo|Placebo (vehicle of the test product) to cover only the lesions with a thin film.
16000321|NCT02886689|Drug|TNF-alpha antagonist and other biotherapy|
16000322|NCT02886676|Drug|Spirulina capsules|Spirulina capsules 2gm daily for 1 month
16000323|NCT02886663|Other|stimulation of the blind visual field|
16000324|NCT02886650|Procedure|Thermocoagulation|Thermocoagulation During pre-surgical Invasive EEG Monitoring
16000325|NCT02886637|Other|None intervention|
16000326|NCT02886624|Drug|Grazoprevir/Elbasvir|Once-daily, oral grazoprevir/elbasvir combination therapy at fixed-dose (100mg/50mg) for 8 weeks
16000327|NCT02886598|Drug|degarelix|
16000328|NCT02886585|Drug|Pembrolizumab|
16000329|NCT02886585|Radiation|MRI|
16000330|NCT02886585|Radiation|PET/CT|
16000331|NCT02886585|Procedure|Stereotactic Radiosurgery|
16000332|NCT02886572|Radiation|Stereotactic radiosurgery|Linear-accelerator-based, single-isocenter, image-guided stereotactic radiosurgery
16000333|NCT02886559|Drug|Chidamide plus DCAG regimen|chidamide, decitabine, aclarubicin, cytarabine and G-CSF
16000339|NCT02886507|Dietary Supplement|NSK-SD (nattokinase)|Nattokinase is a fibrinolytic enzyme from the fermented soy product natto. Encapsulated 100mg/capsule, excipient include microcrystalline cellulose.
16000340|NCT02886507|Dietary Supplement|Placebo|The placebo capsules contain microcrystalline cellulose.
16000341|NCT02886494|Drug|BAC treatment|BAC, topical application on external nasal skin, scalp, and neck, 2 times daily, 30 g/day for 12 weeks
16000342|NCT02886494|Drug|Matched vehicle|BAC matched vehicle, topical application on external nasal skin, scalp, and neck, 2 times daily, 30 g/day for 12 weeks
16000343|NCT02886481|Device|perioperative monitoring|
16000344|NCT02886468|Other|skin ultrasound|
16000345|NCT02886455|Other|Standard adhesive strip|This is a standard adhesive strip (hydrocolloid)
16000346|NCT02886455|Other|New adhesive strip|This a newly developed adhesive strip.
16000347|NCT02886442|Other|Standard adhesive strip|This is a standard adhesive strip (hydrocolloid)
16000348|NCT02886442|Other|New adhesive strip|This is a newly developed adhesive strip
16000349|NCT02886429|Drug|Bupivacaine|Ultrasound guided paravertebral block with bupivacaine
16000350|NCT02886429|Drug|Dexmedetomidine|Ultrasound guided paravertebral block with dexmedetomidine
16000351|NCT02886416|Other|Non interventional study|
16000352|NCT02886403|Other|Standard adhesive strip|A standard adhesive strip (hydrocolloid)
16000353|NCT02886403|Other|New adhesive strip|A newly developed adhesive strip
16000354|NCT02886390|Device|ischemic conditioning|In this study, the remote ischemic conditioning treatment was composed of five cycles of bilateral upper limb ischemia intervened by reperfusion, which was induced by two cuff placed around the upper arms respectively and inflated to 200 mm Hg for 5 minutes followed by 5 minutes of reperfusion by cuff deflation.
16000355|NCT02886377|Biological|blood test of anti-AQP4 antibody|Patients were sub-divided into an AQP4 seropositive group and an AQP4 seronegative group, according to blood test of the AQP4-Ab.
16000356|NCT02886364|Behavioral|Adapted Safe Childbirth Checklist|The World Health Organization has created and endorsed the WHO Safe Childbirth Checklist as a tool for improving quality of care around childbirth. This tool has been modified to the context in Mexico by another group of investigators at the National Institute of Public Health. Our team expanded the Mexican version of the WHO Safe Childbirth Checklist to include indicators around respectful maternity care.
16000357|NCT02886351|Drug|Nitrous Oxide|Nitrous Oxide at 60%-70% concentration administrated by mask, to achieve cooperation in Pediatric dentisry
16000358|NCT02886338|Device|capsule endoscopy|The magnetic navigated CE would enable detailed investigations of the whole upper gastrointestinal tract, including the esophagus, stomach and duodenum. Using this remote magnetic manipulation, capsule endoscope might improve diagnostic accuracy and extend the examination of specific area of interest in the gastrointestinal tract.
16000359|NCT02886312|Device|Supplemental Oxygen Delivery System|
16000360|NCT02886299|Drug|Fenofibrate|
16000361|NCT02886299|Drug|Simvastatin|
16000362|NCT02886286|Drug|Bupivacaine|Patient-activated intrathecal bolus for incident pain
16000363|NCT02886286|Drug|Opioid|Patient-activated intrathecal bolus for incident pain
16000364|NCT02886273|Other|Group 1|Observation
16000365|NCT02886273|Other|Group 2|Observation
16000366|NCT02886273|Other|Group 3|Observation
16000367|NCT02886273|Other|Group 4|Observation
16000368|NCT02886234|Behavioral|Mindfulness Training (MT)|Participants assigned to the MT condition will receive a phone-delivered 30-minute mindfulness training once a week for 8 weeks. ). In addition to the weekly training session, participants will be instructed to practice mindfulness techniques for 15 minutes daily using a standardized audio recording to guide the participant through the techniques learned with the instructor.
16000369|NCT02886234|Behavioral|Health Coaching (HC)|The HC condition will consist of educational modules designed to control for the contact time and attention received in the MT condition. To match the time MT participants will spend doing mindfulness exercises at home, HC participants will be assigned a 15-minute daily activity that is aligned with the HC topics
16000370|NCT02886221|Procedure|Reverdin-Isham Osteotomy|Incision on the medial part of the foot, a Shannon Isham burr was introduced at the junction of metaphysis and epiphysis. It was applied to the flat bone surface achieved previously at approximately 45°, keeping the articular cartilage surface of the first metatarsal head as reference point on the superior cortex. In this position, under fluoroscopic control, the osteotomy was started following a distal-dorsal and proximal-plantar direction. At this point, the burr was slightly withdrawn in order to preserve a few millimetres of the lateral cortex, and the osteotomy of the plantar cortex was performed completely. Then, a Wedge burr was used to create a wedge with a medially oriented base. At the point of closing the wedge, osteoclasis of the preserved lateral cortex was achieved, modifying the orientation of the articular surface, normalizing the DMAA value, and adding an intrinsic stability to the osteotomy by producing contact of the trabecular bone.
16000371|NCT02886208|Behavioral|Measurement|The intervention consists of diabetes prevention education sessions focusing on increasing physical activity and decreasing the intake of sugared drinks while increasing intake of fruits and vegetables. The 2-hr sessions occur weekly for 6 weeks. Height and weight is measured for each consenting participant at baseline and after 6 weeks. Participants are also asked to complete a short questionnaire to collect demographic and knowledge data. Outcome measures include: BMI, knowledge of physical activity and dietary habits conducive to diabetes prevention, and feelings of food insecurity.
16000372|NCT02886195|Drug|pemetrexed|500mg/m2 ivgtt d1, per three weeks
16000373|NCT02886195|Drug|cisplatin|80mg/m2 ivgtt d1, per three weeks
16000374|NCT02886195|Drug|Erlotinib|150mg po. every day
16000375|NCT02886169|Other|High fat meal with Sacha Inchi|Participants will receive 100 g of bread with 70 g of butter (high saturated fat meal) added with 15ml of Sacha Inchi oil and 125ml of coffee with 10g of sugar
16000376|NCT02886169|Other|high saturated fat meal|Participants will receive 100 g of bread with 70 g of butter (high saturated fat meal) and 125ml of coffee with 10g of sugar
16000377|NCT02886156|Device|CPAP|CPAP plus BSC group Participants in the CPAP plus BSC group will receive CPAP treatment plus the aforementioned BSC intervention. CPAP treatment (LOTUS AUTO; Curative Medical Technology Inc., Beijing, China) will be initiated using standard clinical practice at each center. Participants in both groups will be asked to continue their usual medical care during the trial.
16000378|NCT02886156|Dietary Supplement|BSC|BSC only group Participants in the BSC only group will receive advice regarding lifestyle modification, sleep hygiene, naps, exercise, caffeine, and diet, and avoiding alcohol consumption, but no specific weight loss program, diet, or salt restriction will be suggested.
16000379|NCT02886143|Procedure|Active Voiding Trial|"Nursing protocol:
~Instill 250-400 cc of STERILE SALINE via the lumen of the Foley catheter into the bladder via gravity drainage or slow push
~Clamp the Foley
~Deflate the catheter balloon and remove the catheter from the bladder.
~Record the amount of saline that was instilled into the bladder.
~Immediately assist the patient to void. Report the amount instilled and the amount voided to the physician within one hour a. Unless the patient reports extreme bladder fullness or pain, give the patient one hour to urinate
~7. If the patient fails the voiding trial, the physician will decide to do in and out catheterization or place a new Foley catheter"
16000380|NCT02886143|Procedure|Passive Voiding Trial|"Nursing protocol:
~Deflate the catheter balloon and remove the catheter from the bladder.
~Record the time that the catheter was removed and the time the patient is due to void (approximately 6 hours).
~5. If the patient has not voided within 5 hours, assist the patient to try to void.
~6. If the patient is unable to void, is only voiding in small amounts, or reports fullness or abdominal pain, perform a bladder scan.
~7. If the patient has not voided after 6 hours, report this to the physician along with the results of the bladder scan 8. The physician will decide to do in and out catheterization or place a new Foley catheter"
16000381|NCT02886130|Dietary Supplement|Placebo|Monitoring of supplementation (e.g., compliance, subject blindness), diet (to control dietary choline ingestion), training volume and adverse effects will be performed on a weekly basis to ensure maximal control of confounding factors as well as the safety of volunteers during the study.
16000382|NCT02886130|Dietary Supplement|Experimental|Monitoring of supplementation (e.g., compliance, subject blindness), diet (to control dietary choline ingestion), training volume and adverse effects will be performed on a weekly basis to ensure maximal control of confounding factors as well as the safety of volunteers during the study.
16000383|NCT02886104|Procedure|CRLM resection group|Simultaneous resection of both primary and secondary tumors in synchronous CRLM or resection of metachronous CRLM.
16000384|NCT02886104|Device|CRLM ablation group|Microwave ablation of CRLM with a 2.15-gigahertz(GHz) microwave generator and a 14 gauge diameter transcutaneous antenna within 30 days after resection of primary tumor in synchronous CRLM or ablation of metachronous CRLM.
16000385|NCT02886078|Procedure|Dorsal approach CapFlex arthroplasty|Arthroplasty of the PIP joint with the CapFlex implant. Surgery will be done with the dorsal approach.
16000386|NCT02886078|Procedure|Volar approach CapFlex arthroplasty|Arthroplasty of the PIP joint with the CapFlex implant. Surgery will be done with the volar approach.
16000387|NCT02886065|Drug|Hiltonol|Intramuscular injection of Hiltonol (1 mg) administered Biweekly at the time of PVX-410 administration
16000388|NCT02886065|Drug|Citarinostat|Citarinostat (180 mg) administered orally once daily on days 1-21 every 28 day cycle.
16000389|NCT02886065|Drug|Lenalidomide|Lenalidomide (25 mg) administered orally once daily on days 1-21 every 28 day cycle.
16000390|NCT02886065|Biological|PVX-410|PVX-410 Biweekly (0.8 mg) via subcutaneous injection
16000391|NCT02886052|Behavioral|Therapist guided Internet-CBT for insomnia|
16000392|NCT02886052|Other|Active control|
16000393|NCT02886039|Other|Electroencephalogram|Prognostic evaluation of electroencephalogram score created with a retrospective cohort Creation of composite score to predict neurologic outcome in cardiorespiratory arrest
16000394|NCT02886026|Device|Bladder tumor resection using diathermia|Conventional bladder tumor resection using diathermia
16000395|NCT02886026|Device|Diode laser (980 nm) tumor destruction|Laser mediated destruction of bladder tumors (LMD-BT)
16000396|NCT02885987|Device|AmplifEYE|AmplifEYE will be attached to the tip of the colonoscope prior to start of procedure.
16000397|NCT02885974|Drug|Celecoxib|Celecoxib (100 mg daily)
16000398|NCT02885974|Drug|Gemcitabine|1,000 mg/m2 (IV), on Days 1 and 8 of each 21-day cycle. Up to 4 cycles.
16000399|NCT02885974|Drug|Cisplatin|70 mg/m2 (IV), on Day 1 of each 21-day cycle. Up to 4 cycles.
16000400|NCT02885961|Drug|Dabigatran|Anti-coagulant
16000401|NCT02885961|Radiation|FDG PET scan|Scan using PET combined with a high resolution CT scan (HRCT)
16000402|NCT02885948|Drug|Naloxone|used to block the effects of opioids, especially in overdose
16000403|NCT02885948|Drug|Placebo|Placebo, ineffective control arm
16000404|NCT02885935|Other|Recommended protein intake|Recommended protein intake diet contained 10% protein, 55% carbohydrate,and 35 % fat.
16000405|NCT02885935|Other|Elevated protein intake|Recommended protein intake diet contained 20% protein, 45% carbohydrate,and 35 % fat.
16000406|NCT02885922|Drug|anti-diabetic drug|Add-on anti-diabetic drug in type 2 diabetic patients
16000407|NCT02885909|Device|CONTINUE GLUCOSE MONITOR|Continue glucose monitor
16000408|NCT02885909|Procedure|Insulin protocal|Using insulin protocal based on glucose monitor
16000409|NCT02885883|Device|MRI 3T|
16000410|NCT02885870|Procedure|Combination of multiparametric MRI and electrophysiology|MRI and electrophysiology will be combined in order to assess the human spinal cord, at both macro and microscopic levels. Specific biomarkers of white and grey matter degeneration will be developed and validated in pathologies that affect differentially white and grey matter: spinal muscular atrophy, X-linked spinal bulbar muscular atrophy and Amyotrophic lateral sclerosis
16000411|NCT02885857|Drug|Shenyan Kangfu Tablet|Observation period: 24 weeks. The dosage regimen: each piece weighs 0.48 g. 5 / time, 3 times daily, orally after dinner.
16000412|NCT02885844|Procedure|INVERTED VISION|The tasks will be performed either with normal or inverted vision (upside down) using commercial off-the-shelf inverting prism goggles
16000413|NCT02885844|Procedure|NORMAL VISON|subject's field of view will be restricted by goggles without lenses in order to be equivalent to the inverted vision one.
16000414|NCT02885831|Device|Abduction splintage|Treatment by abduction splintage 24 hours a day and 7 days a week, for 2 months.
16000415|NCT02885805|Drug|BAY987516|2.00 mg/cm2 ± 0.04 mg/cm2
16000416|NCT02885805|Drug|SPF 15 Control|2.00 mg/cm2 ± 0.04 mg/cm2
16000417|NCT02885792|Other|Illness history|Existing psychiatric and somatic diagnosis and treatment. Charlson co-morbidity Index.
16000418|NCT02885792|Other|Measure of social conditions|A self-report questionnaire measuring social isolation, including relations to family and friends.
16000419|NCT02885792|Other|Measure of psychiatric condition|This method measures symptom severity, therapeutic response and general improvement, suicidal ideation, cognitive insight and awareness of illness and need for treatment and the ability to relabel symptoms.
16000420|NCT02885792|Procedure|Cardiovascular measurement|This procedure is used to detect early identification of cardiovascular disease progression.
16000421|NCT02885766|Drug|PF-114|
16000422|NCT02885753|Drug|Oxaliplatin intravenous|85 mg/m² in intravenous. 1 cycle each 15 days
16000423|NCT02885753|Drug|5 Fu|5 fluorouracil : 400 mg/m² in bolus of 10 minutes (intravenous) following by 2400 mg/m² during 46 hours in intravenous
16000424|NCT02885753|Drug|Folinic Acid|400 mg/m² in intravenous
16000425|NCT02885753|Drug|Oxaliplatin intra-arteriel|85 mg/m² in intra-arterial. 1 cycle each 15 days
16000426|NCT02885753|Drug|Panitumumab|Only for patient RAS wild: 6 mg/Kg at each cycle in intravenous
16000427|NCT02885753|Drug|Bevacizumab|Only for patient RAS mutated : 5 mg/m² at each cycle in intravenous
16000428|NCT02885740|Other|Quantification assay of adenosine and methionine cycle metabolites|
16000429|NCT02885740|Genetic|Polymorphism analysis of genes related to adenosine metabolism and methionine cycle|
16000430|NCT02885740|Other|Quantitative and qualitative nutritional evaluation|Questionnaire on consumption of 208 foods and drinks
16000431|NCT02885740|Biological|Blood sample|
16000432|NCT02885727|Drug|Durvalumab|Evaluate if the combination of RT and durvalumab can improve median PFS compared to chemotherapy historical control data in metastatic pancreas cancer patients who have progressed through first-line chemotherapy
16000433|NCT02885727|Radiation|Radiation Therapy|The primary intent of RT in this study is to augment a pancreatic cancer-specific immune response when given with durvalumab.
16000436|NCT02885701|Other|No Splint|The no splint group received a soft dressing consisting of an occlusive petroleum gauze strip (Xeroform, Mansfield, MA) over the wound, one folded 4x4 gauze, and a single wrap of roll gauze around the hand, and the wrist was placed and secured by a Coban wrap (3M, St. Paul, MN). The dressing permitted wrist and finger motion. Patients were further instructed to remove the dressing at five days and place an adhesive bandage (Band-Aid, Johnson & Johnson, New Brunswick, NJ) over the incision.
16000437|NCT02885701|Other|Removable Splint|The removable splint group received a V-strap Wrist support (Medical Specialties, Inc., Charlotte, NC) placed over the identical soft dressing that was placed on the no splint group. The cock-up wrist splint was designed to keep the wrist fixed in a 20 degree extended wrist position. Patients were instructed to wear the splint for comfort as needed during day and night. While the patient was wearing the cock-up splint, only finger motion was permitted. Wrist motion was permitted when the cock-up splint was removed.
16000438|NCT02885701|Other|Non-removable Splint|The plaster non-removable splint group received an occlusive petroleum gauze strip placed over the wound, followed by a 4X4 gauze, and a Webril cotton roll wrap (Covidien, Inc., Covidien, Ireland). A 4- inch, 15-layer thick plaster splint was placed across the volar wrist and molded to keep the wrist in approximately 20 degrees of extension allowing full digital range of motion (ROM). The splint was to be kept dry and not removed by the patient.
16000439|NCT02885688|Dietary Supplement|Liquid Nutrition|Participants receive liquid nutrition by vein non-stop for up to 7 days.
16000440|NCT02885688|Procedure|Insulin Drip|"Insulin drip by vein to keep serum glucose level between 140 and 180 mg/dL as per ICU protocol.
~The interventions required in the current standard management of patients with septic shock is based on the MD Anderson Evidence-Based Protocol (EBP) for management of Severe Sepsis initiated on admission to the ICU."
16000441|NCT02885675|Other|blood sampling|sample no more than 3ml
16000442|NCT02885662|Drug|CS-3150|CS-3150 2.5 to 5.0 mg , orally.
16000443|NCT02885649|Drug|Enzalutamide|Given PO
16000444|NCT02885649|Other|Laboratory Biomarker Analysis|Correlative studies
16000445|NCT02885649|Procedure|Nephrectomy|Undergo partial or radical nephrectomy
16000446|NCT02885636|Drug|Albuterol|": Experimental: Inhaled albuterol
~2.5 mg inhaled albuterol through a high efficiency nebulizer as a single dose"
16000447|NCT02885636|Other|Saline placebo|Saline inhaled through a nebulizer as a single dose
16000448|NCT02885610|Biological|Placebo plus standard therapy|Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive and immunomodulator therapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,leflunomide, Tacrolimus ,ciclosporin )
16000449|NCT02885610|Biological|RC18 80 mg plus standard therapy|Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive and immunomodulator herapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,leflunomide, Tacrolimus ,ciclosporin )
16000450|NCT02885610|Biological|RC18 160 mg plus standard therapy|Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive and immunomodulator herapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,leflunomide, Tacrolimus ,ciclosporin )
16000451|NCT02885610|Biological|RC18 240 mg plus standard therapy|Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressive and immunomodulator therapy(i.e.,azathioprine,mycophenolate ,cyclophosphamide,methotrexate,leflunomide, Tacrolimus ,ciclosporin )
16000452|NCT02885597|Drug|Juanbi pill|4g, twice a day, 3month, oral
16000453|NCT02885597|Drug|Juanbi pill placebo|4g, twice a day, 3month, oral
16000454|NCT02885597|Drug|Methotrexate|5mg, once a week, 3 month, oral
16000455|NCT02885584|Device|High frequency percussive ventilation|
16000456|NCT02885571|Device|SomnoDent Flex with DentiTrac|
16000457|NCT02885558|Drug|Efonidipine|8 weeks treatment with either efonidipine
16000458|NCT02885558|Drug|Nifedipine|8 weeks treatment with either nifedipine
16000459|NCT02885545|Device|Watchman|If the patient is randomized to the Intervention Arm of the study the Watchman device will be implanted into the left atrial appendage of the heart
16000460|NCT02885545|Drug|Continued therapy with the prescribed oral anticoagulant|If the patient is randomized to the control arm of the study, they will continue taking the oral anticoagulant that has been prescribed (vitamin K antagonist, Apixiban 2.5mg bid or Rivaroxaban 15mg od)
16000461|NCT02885532|Other|University of California, San Diego Brief Assessment of Capacity to Consent Tool|Non-pregnant, English speaking patients older than 18 with evidence of acute alcohol intoxication were considered eligible for participation. Patients were asked to complete the 10 question tool on arrival to the emergency department. Patie
16000462|NCT02885519|Behavioral|IBBIS mental health care and standard vocational rehabilitation|"Standard vocational rehabilitation.
~Stepped mental health care provided by the IBBIS mental health care team (e.g. nurses, psychologists and medical doctors) with the treatment modalities:
~Psychoeducation Bibliotherapy Stress-coaching Mindfulness-based stress reduction Monitoring and re-assessment"
16000463|NCT02885519|Behavioral|Integrated mental health care and vocational rehabilitation|"Integrated mental health care and vocational rehabilitation provided by the IBBIS team. The IBBIS team is composed by employment specialists from the municipal job centers and health care professionals from the mental health services (e.g. nurses, psychologists, and medical doctors).
~Mental health care is provided according to a stepped care model with the following treatment modalities:
~Psychoeducation Bibliotherapy Stress-coaching Mindfulness-based stress reduction Monitoring and re-assessment
~Vocational rehabilitation is inspired by Individual Placement and Support and is a workplace-oriented intervention with problem-solving conversations as a core element"
16000464|NCT02885506|Drug|Oral administration of P218 capsules|Oral administration of P218 capsules. The number of capsules is determined by the dose level of the cohort.
16000465|NCT02885506|Drug|Oral administration of P218 matching placebo|Oral administration of P218 matching placebo. The number of capsules is identical to the corresponding number of P218 capsules administered to the volunteers on the investigational drug.
16000466|NCT02885493|Behavioral|tests|
16000467|NCT02885480|Behavioral|questionnaires|
16000468|NCT02885467|Procedure|Total knee arthroplasty with Saphenous nerve burial|
16000469|NCT02885467|Procedure|Standard total knee arthroplasty|
16000470|NCT02885454|Drug|Drospirenone/ethinylestradiol|Each tablet contains 3 mg drospirenone and 0.02 mg ethinylestradiol to be taken orally on Days 1, 6, 25, and 32.
16000471|NCT02885454|Drug|AL-335|AL-335 (800 mg) tablet once daily on Days 5-7 and then on Days 26-32 (as a component of 3-DAA combination) to be taken orally.
16000472|NCT02885454|Drug|Odalasvir (ODV)|ODV 25 mg tablet once daily on Days 12-25 and then on Days 26-32 (as a component of 3-DAA combination) to be taken orally.
16000473|NCT02885454|Drug|Simeprevir (SMV)|SMV 75 mg capsule as a component of 3-DAA combination to be taken orally on Days 26-32.
16000474|NCT02885441|Drug|Ketorolac|Ketorolac, 10 mg, 3 times daily from time of enrollment until 72 hours from enrollment. For up to a maximum of 9 doses.
16000475|NCT02885428|Device|echography|
16000476|NCT02885415|Procedure|Gastrointestinal surgery|Major resectional gastrointestinal surgery (define as resection of part of gastrointestinal tract during esophageal, Gastric or colorectal surgeries)
16000477|NCT02885402|Other|MRI Sodium ( 23Na )|
16000478|NCT02885376|Device|Dentoxol|Mouthrinse
16000479|NCT02885376|Device|Placebo|Mouthrinse
16000480|NCT02885363|Other|Clinical examination|
16000481|NCT02885363|Other|Blood sample|
16000482|NCT02885363|Procedure|Echocardiography|
16000483|NCT02885350|Drug|Spinal analgesia for labour pain|Intrathecal dose of either fentanyl or sufentanil delivered by combined spinal-epidural technique
16000484|NCT02885350|Drug|Epidural analgesia for labour pain|Epidural dose of either fentanyl or sufentanil delivered through an epidural catheter.
16000485|NCT02885337|Other|Multi-Modal Frailty Intervention|"Exercise: A physiotherapist will develop an individualized exercise program and schedule appointments with the patient at a physiotherapist clinic. Participants will be offered free YMCA membership.
~Cognitive-behavioural Change Strategy(CBCS) and education: Throughout the intervention, CBCS and education about exercise, hip or knee arthroplasty and osteoarthritis will be administered.
~Protein Supplement: Participants will be provided with 1-2 daily supplements (containing 20-40 gram protein, 1.5 g β-Hydroxy β-Methylbutyrate /serving) to be taken with a meal or on activity days within 3-hours of exercise.
~Vitamin D: All participants in the intervention arm will be provided with a supply of Vitamin D3 (1000 IU/day tablets) for the duration of the intervention period.
~Medication Review: A geriatrician will review the medications for patients in the intervention arm."
16000486|NCT02885337|Other|Usual Care|"Patients in the control arm will receive usual care which may include the recommendation to attend fitness classes before surgery, however these patients will not receive the more intensive assessment/intervention of the physiotherapist and other intervention components. Control participants will be asked pre-operatively and post-operatively to indicate whether or not they exercise, take protein or vitamin supplements.
~For participants in intervention and control groups will, 1) we will monitor the YMCA attendance and 2) participants will be instructed on the completion a dietary intake log (including days of the week and weekend days) that indicate the type of food and amount over a four-day period in order to calculate energy and micronutrient consumption."
16000487|NCT02885324|Drug|Cabozantinib|Subjects will receive Cabozantinib
16000631|NCT02884089|Drug|Abemaciclib|Administered orally
16000632|NCT02884089|Drug|Metformin|Administered orally
16000488|NCT02885311|Behavioral|Motivation Enhancement Therapy|Motivation Enhancement Therapy (MET) similarly allows for goal choice in treatment, and has been shown to be effective in treating a broad spectrum of drinking problems in both abstinent and non-abstinent goal conditions. The unique goals of MET (enhancing intrinsic motivation for change and facilitating development of a self-generated change plan).
16000489|NCT02885311|Behavioral|Modified Behavioral Self-Control Therapy|Motivational Interviewing was developed to increase self-efficacy and motivation for drinking, and Cognitive Behavioral Therapy allows for individuals to develop strategies for drinking reduction. Both are evidence-based interventions that have been combined in previous studies for drinking reduction in problem drinkers.
16000490|NCT02885311|Drug|Naltrexone|Participants, who choose medication treatment, will be offered naltrexone (50 mg per day), which is an FDA-Approved medication for alcohol use disorder. According to the package insert for NTX, the medication has been associated with liver toxicity at very high doses (up to 300 mg/day); however, a number of clinical trials and published studies suggest there are few serious adverse effects, including minimal hepatotoxicity, associated with daily dose of 50 mg of naltrexone. Its most common side effects in opioid-free individuals are nausea, vomiting, anxiety, headache, abdominal discomfort, difficulty sleeping, fatigue, irritability, and decreased appetite. A rare serious adverse effect may include minimal liver toxicity, but is more likely to occur at very high doses (300 mg/day).
16000491|NCT02885311|Behavioral|Brief Advice|Brief Advice (BA) consists of a 20-minute session delivered by a study therapist, adhering to the NIAAA's Clinician Guide to Problem Drinkers. It includes personalized, normative feedback based on NIAAA drinking norms, goal selection, instructions on self-monitoring, discussion of drink reduction strategies, and distribution of the NIAAA bibliotherapy guide.
16000492|NCT02885311|Other|Referral to specialty substance use disorder treatment|Participants who present with complex drinking concerns will be referred to specialty substance use disorder treatment. This treatment will be provided in a separate treatment facility that focuses on substance use disorders and will potentially provide a combination of medication management and individual/group behavioral treatment for substance use disorders.
16000493|NCT02885298|Procedure|Upright intubation|Upright Intubation procedure performed with patient elevated above the supine position. Defined as upright greater to or equal to 45 degrees or inclined 10-44 degrees
16000494|NCT02885285|Behavioral|Spinning Class|Spinning Class twice a week for six weeks.
16000495|NCT02885285|Behavioral|Yoga Class|Yoga Class twice a week for six weeks.
16000496|NCT02885285|Behavioral|Dance Class|Dance Class twice a week for six weeks.
16000497|NCT02885285|Other|No Exercise Class|No exercise class. Subject will continue regular activities for six weeks.
16000498|NCT02885272|Procedure|Computed Tomography|Undergo PET/CT scans
16000499|NCT02885272|Radiation|Fludeoxyglucose F-18|Given IV
16000500|NCT02885272|Procedure|Magnetic Resonance Imaging|Undergo standard of care MRI
16000501|NCT02885272|Procedure|Positron Emission Tomography|Undergo PET/CT scans
16000502|NCT02885259|Drug|rHuPH20|human immunoglobulin and one vial of recombinant human hyaluronidase
16000503|NCT02885246|Other|Data collection|The ICGES database of Panama will be checked for all seasonal influenza A and/or B positive cases reported via influenza surveillance programs from 2010 to 2015.
16000504|NCT02885233|Behavioral|Free From Falls Online|Subjects in the active group will participate in the Free From Falls Online Program consisting of 8 weekly 30 minute webinars providing education about risk factors for falls and fall prevention strategies; self-assessment exercises to evaluate understanding of the material; video-based exercise program targeting balance, posture, strength and flexibility to be performed at least 3 times per week; supplementary, downloadable printed material for both education and exercise; and a social forum to allow participants to interact with each other.
16000505|NCT02885233|Behavioral|Waitlist Control|"Subjects in the waitlist control condition will receive an educational brochure developed by the National Multiple Sclerosis Society called Minimizing Your Risk of Falls: A Guide for People with MS, which includes information on identifying risk factors for falling and fall risk management approaches with no exercise component; will inform their provider that they have fallen at least twice in the previous 2 months and discuss subsequent falls over the course of the 5-month study; and will be invited to participate in the Free From Falls Online Program at study completion."
16000506|NCT02885220|Other|Conventional Program|No scheduled intermediate weight loss goals provided to patient
16000507|NCT02885220|Other|Goal-directed Program|Scheduled program with intermediate weight loss targets reinforced to patients during follow up.
16000508|NCT02885207|Biological|Focal epilepsy of unknown cause|"Male or female 18-65 years presenting focal epilepsy on the following arguments:
~Crisis with clinical symptoms indicating focal seizure
~& / Or crisis or critical focal inter-recorded EEG interpreted by a neurologist with expertise in the field of epilepsy.
~From unknown cause:
~No evidence of injury (excluding temporal or hyperintensity of hippocampal sclerosis) on brain MRI with focus on regions of interest cuts.
~No discharge or generalized photosensitivity recorded over an extended interpreted by a neurologist with expertise in the field of epilepsy video-EEG.
~No argument for metabolic or neurodegenerative genetic epilepsy.
~Normal neurological examination. Epilepsy that started within a maximum period of 2 years prior to inclusion in the study (including vegetative symptoms of temporal focal seizures).
~Without treatment by benzodiazepines or anti-epileptics first-line monotherapy (excluding benzodiazepines)."
16000509|NCT02885194|Other|Laser-Evoked potential|Laser-Evoked potential can document lesions of spinothalamic tract and lateral brainstem and of thalamo-cortical projections conducting nociceptive signals. The rapid heating of skin by infrared laser pulses stimulate small fibers sensory pathways. The main cortical laser evoked potential is a complex of components N2-P2. Evaluation of the registered potentials includes shape, latency and amplitude.
16000510|NCT02885181|Drug|GS-9876|One tablet administered orally once daily
16000511|NCT02885181|Drug|Filgotinib|Two tablets administered orally once daily
16000512|NCT02885181|Drug|GS-9876 placebo|One tablet administered orally once daily
16000513|NCT02885181|Drug|Filgotinib placebo|Two tablets administered orally once daily
16000514|NCT02885181|Drug|Methotrexate|Background therapy with methotrexate administered orally or parenterally once weekly
16000515|NCT02885168|Drug|Recombinant Activated Protein C|24 μg/kg/h during 96 hours - intravenous injection
16000633|NCT02884089|Drug|Iohexol|Administered intravenously (IV)
16000634|NCT02884089|Drug|Placebo|Administered orally
16000516|NCT02885168|Device|Near-infrared spectroscopy (NIRS)|After baseline measurement, cuff is blown up to obtain a muscular saturation at 40% and then deflated. Reactive hyperthermia is measured. It is considered as an index for endothelial function.
16000517|NCT02885168|Drug|Phenylephrine|"Continuous administration of phenylephrine with electric syringe with increasing dosing levels: 0.0; 0.02; 0.05; 0.1; 0.2; 0.5; 0.75; 1.00; 1.50; 3.00; 4.50; 6.00; 9.00 et 12 µg/kg/min. Each level is maintained for 5 minutes. Administration of phenylephrine is stopped progressively with the same schema.
~Arterial tension through an invasive approach is measured during the test."
16000518|NCT02885168|Biological|Blood sample|Analysis of inflammation and cellular adhesion markers and free radicals
16000519|NCT02885155|Other|Echocardiography|planned at regular intervals
16000520|NCT02885155|Other|Hemodynamic examinations (right cardiac catheterization)|planned at regular intervals
16000521|NCT02885142|Procedure|Local excision for early rectal cancer|
16000522|NCT02885116|Device|Nasal high flow (NHF) supplementation|use of NHF for 20 min/ 35 l/min, at the end of this period right heart catheterization
16000523|NCT02885116|Device|oxygen supplementation|hypoxemic patients will use their normal oxygen supplementation durch right heart catheterization
16000524|NCT02885103|Device|Nasal high flow (NHF)|NHF will be combinated with a nebulizer. Inhalation will be done on nasal cavity.
16000525|NCT02885103|Device|Nebulizer|Inhalation will be done will Nebulizer and via mouth
16000526|NCT02885090|Procedure|Blood sampling|In children: 2 EDTA tubes of 7 ml, 1 Heparin Li tube of 5 ml and 2 PAXgene tubes of 2.5 ml (max 0.8-0.9 ml blood/kg) In parents: 2 EDTA tubes of 7 ml, 1 Heparin Li tube of 5 ml.
16000527|NCT02885077|Device|High-intensity IMT + combined exercise|
16000528|NCT02885051|Procedure|Recording of skin conductance and heart rate variability.|When a procedure of care will be prescribed, installation of the electrodes of measure of the cutaneous conductance on the foot and connection of the NIPE monitor to the cardio-respiratory monitor of the child used in routine. At this stage, beginning of the video recording.
16000529|NCT02885038|Other|Platelet concentrate transfusion|
16000530|NCT02885025|Dietary Supplement|Broccoli Sprout Extract|Broccoli Sprout Extract contains the antioxidant Sulforaphane which is the active ingredient being studies.
16000531|NCT02885025|Drug|fluticasone nasal|fluticasone is a nasal steroid that is currently approved for treatment of allergic rhinitis.
16000532|NCT02885025|Dietary Supplement|broccoli sprout extract placebo|a tablet similar to the actual broccoli sprout extract though without BSE.
16000533|NCT02885025|Drug|normal saline nasal spray|normal saline to replace nasal fluticasone in specific arms of the study
16000534|NCT02885012|Drug|Ambrisentan|At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan.
16000535|NCT02884986|Drug|Etoricoxib|120mg of oral etoricoxib under the brand name Arcoxia® (Merck Sharp & Dohme) one hour prior to spinal anaesthesia induction
16000536|NCT02884986|Drug|Placebo|120mg of placebo
16000537|NCT02884960|Procedure|Uterine Fibroid Embolization|This procedure involves the administration of the study device into the uterine arteries to block the flow of blood in these vessels. This deprives fibroid tumors within the uterus of their blood flow, which can cause the tumors to die. This in turn can lead to the relief of symptoms associated with fibroids.
16000538|NCT02884921|Drug|Paracetamol|Paracetamol
16000539|NCT02884921|Drug|Paracetamol|Paracetamol
16000540|NCT02884921|Drug|Placebo|Placebo
16000541|NCT02884908|Drug|Pregabalin plus BBCET|Medication; BBCET = Brief Behavioral Compliance Enhancement Treatment
16000542|NCT02884908|Other|Placebo plus BBCET|Placebo; BBCET = Brief Behavioral Compliance Enhancement Treatment
16000543|NCT02884895|Device|Intubating Laryngeal Tube Suction|Intubating Laryngeal Tube Suction Disposable
16000544|NCT02884895|Device|Direct Laryngoscopy|Direct Laryngoscopy
16000545|NCT02884882|Other|Emotional induction|Score (from 1 to 10) rated the felt for each target emotions for the following 6 dimensions: joy, sadness, fear, disgust, anger, no emotion, after the presentation of short sequences of standardized films.
16000546|NCT02884869|Device|Intubating Laryngeal Mask|Direct laryngoscopy
16000547|NCT02884843|Device|Intubation laryngeal Tube Suction|Intubation laryngeal Tube Suction
16000548|NCT02884843|Device|AuraGain Laryngeal Mask|AuraGain Laryngeal Mask
16000549|NCT02884830|Device|continuous positive airway pressure|positive airway pressure given by a medical device through a nasal mask
16000550|NCT02884817|Drug|Experimental: essential oils and ELA|The participants were instructed to insert the tooth guard in Q1 every time they brushed their teeth and to perform a mechanical oral hygiene routine twice a day in the three other quadrants. After brushing properly, they were instructed to rinse for 30s with water before removing the tooth guard. And then rinse again for 30s with water without the mouth guard. Following this procedure the participants rinsed, as instructed, with the Experimental solution, Listerine Gum Therapy. This oral hygiene routine was repeated for 21d.
16000551|NCT02884817|Other|Placebo|The participants were instructed to insert the tooth guard in Q1 every time they brushed their teeth and to perform a mechanical oral hygiene routine twice a day in the three other quadrants. After brushing properly, they were instructed to rinse for 30s with water before removing the tooth guard. And then rinse again for 30s with water without the mouth guard. Following this procedure the participants rinsed, as instructed, with the 21.6% hydroalcoholic solution. This oral hygiene routine was repeated for 21d.
16000552|NCT02884817|Other|Water|The participants were instructed to insert the tooth guard in Q1 every time they brushed their teeth and to perform a mechanical oral hygiene routine twice a day in the three other quadrants. After brushing properly, they were instructed to rinse for 30s with water before removing the tooth guard. And then rinse again for 30s with water without the mouth guard. Following this procedure the participants rinsed, as instructed, with the sterile water, sham comparator. This oral hygiene routine was repeated for 21d.
16000553|NCT02884791|Dietary Supplement|oral carbohydrate challenge|Participants will fast for 8 hours and then drink a beverage containing fructose.
16000626|NCT02884128|Drug|PEP02|PEP02 was administered on Day 1. Treatment repeated every 3 weeks and it was regarded as one cycle of treatment.
16000627|NCT02884128|Drug|5-FU|5-FU/LV were started after the end of PEP02 infusion on Day 1 and also on Day 8. Treatment repeated every 3 weeks and it was regarded as one cycle of treatment.
16000554|NCT02884778|Diagnostic Test|Detection of pain after nociceptive stimulus|We will evaluate the changes of the NoL index absolute values after different types of stimulations such as intubation and electrical tetanic stimulation of the forearm (applied with the standard muscle relaxation monitor) in a patient under general anesthesia + epidural anesthesia for abdominal surgery
16000555|NCT02884765|Procedure|Non-surgical|Non-surgical treatment in both condylar fractures
16000556|NCT02884765|Procedure|Non-surgical / Surgical|Non-surgical treatment in one condylar fracture and surgical treatment of the contralateral fracture
16000557|NCT02884765|Procedure|Surgical|Surgical treatment in both condylar fractures
16000558|NCT02884739|Other|Data collection|
16000559|NCT02884726|Drug|BMS-986148|Specified dose on specified days
16000560|NCT02884713|Drug|Levofloxacin|The primary objective was to evaluate the efficacy of the 10-day course of levofloxacin, doxycycline and esomeprazole in non-responders to first-line therapies for H. pylori eradication in Saudi Arabia. Secondary objectives included; symptoms response to treatment, factors associated with eradication of H. pylori and adverse events associated with the treatment
16000561|NCT02884713|Drug|Doxycycline|The primary objective was to evaluate the efficacy of the 10-day course of levofloxacin, doxycycline and esomeprazole in non-responders to first-line therapies for H. pylori eradication in Saudi Arabia. Secondary objectives included; symptoms response to treatment, factors associated with eradication of H. pylori and adverse events associated with the treatment
16000562|NCT02884713|Drug|Esomeprazole|The primary objective was to evaluate the efficacy of the 10-day course of levofloxacin, doxycycline and esomeprazole in non-responders to first-line therapies for H. pylori eradication in Saudi Arabia. Secondary objectives included; symptoms response to treatment, factors associated with eradication of H. pylori and adverse events associated with the treatment
16000563|NCT02884700|Biological|Real-time PCR testing of lower respiratory tract samples|qPCR and high-throughput DNA sequencing testing of lower respiratory tract samples collected routinely in patients with severe legionellosis
16000564|NCT02884674|Device|Active Repetitive Transcranial Magnetic Stimulation|modulation of the electrical activity of the right inferior frontal gyrus cortex in order to reduce Obsessive Compulsive Disorders symptoms by Active Transcranial Magnetic Stimulation (TMS) targeting the right frontal inferior gyrus, 2 sessions per day, each session 5min30 day, during 10 consecutive days, using theta burst stimulation and using a TMS neuronavigated robot
16000565|NCT02884674|Device|Placebo Repetitive Transcranial Magnetic Stimulation|Sham rTMS will be delivered using non active magnetic coil, targeting the right frontal inferior gyrus, 2 sessions per day, each session 5min30 day, during 10 consecutive days, using TMS neuronavigated robot. A subjective sensation will be obtained via frontal dermic electrical stimulation.
16000566|NCT02884648|Drug|Bevacizumab|15 mg/kg by vein on Day 1 of every 21-day study cycle.
16000567|NCT02884635|Drug|ASP1707|Oral
16000568|NCT02884635|Drug|Placebo|Oral
16000569|NCT02884635|Drug|Methotrexate|Methotrexate will be orally administered at stable dose from at least 28 days prior to screening through the screening and treatment periods until the end of the follow-up period.
16000570|NCT02884622|Other|nasal epithelial|CF patients with the same procedures as in the usual management of routine care, only the sampling nasal epithelial cells will be added
16000571|NCT02884622|Other|Blood sampling|CF patients with the same procedures as in the usual management of routine care, only the sampling 5ml additional blood will be taken
16000572|NCT02884596|Drug|selective serotonin reuptake inhibitor|Taking any type of SSRI medicaments
16000573|NCT02884583|Other|Pulmonary function test|Patients hospitalized for OFC realise a Resting pulmonary function tests (PFT) which include the assessment of ventilatory capacity: spirometry (forced expiratory flows and mobilisable volumes) and static volume assessment, by using body plethysmography, were realized before, during and after the OFC. An exhaled fraction of NO (FeNO) is also realized to characterize asthma.
16000574|NCT02884570|Other|Auto-Questionnaires|Consents and questionnaires will be sent to the parental home or filled in an interview with an investigator (or telephone consultation).
16000575|NCT02884557|Other|collection of gut biopsies collection of blood samples|Four to eight colon biopsies will be sampled during endoscopy. Thirty milliliters of blood will be sampled.
16000576|NCT02884544|Drug|HLD100|Treatment
16000577|NCT02884531|Other|Patient Education and Basic Body Awareness Therapy|Patient education (1/2 day) and a Physiotherapy movement modality (12 times, once a week)
16000578|NCT02884531|Behavioral|Patient Education|Patient education (1/2 day)
16000579|NCT02884518|Device|PET|Subjects in the patient group will receive a reduced intake of antipsychotics by 25% after each week of the four-week period in which they and healthy controls will also undergo PET imaging at the baseline, 7 week, and 8 week marks to detect the correlation between the capacity of presynaptic dopamine and relapse in the patients discontinuing treatment.
16000580|NCT02884518|Behavioral|clinical scale|Healthy controls should complete clinical scales at baseline. Patient group should complete clinical scales at 0, 2, 4, 6, and 8 week.
16000581|NCT02884505|Device|Pupillometry|Measures pupillary dynamics in darkness and light conditions
16000582|NCT02884505|Behavioral|Psychomotor Vigilance Task|Response time task measuring neurobehavioral alertness
16000583|NCT02884505|Other|Auditory Evoked Potential|Measure of electroencephalographic response to standardized auditory tones
16000584|NCT02884505|Behavioral|Hypersomnia Severity Index|Self-report measure of hypersomnolence
16000585|NCT02884492|Drug|18F-THK-5351|18F-THK-5351 is a PET radioligand that binds abnormal tangles made of the protein tau. These tau tangles develop in the brain in people with Alzheimer's disease.
16000586|NCT02884492|Procedure|Lumbar Puncture (optional)|Subjects have the option to have lumbar puncture performed for the measurement of Alzheimer's disease biomarkers in cerebrospinal fluid.
16000587|NCT02884479|Drug|PT-112|Increasing doses of intravenously administered PT-112 in combination with 60 mg/m2 docetaxel every 3 weeks (Q3W) in subjects with advanced solid tumor of any histological type.
16000588|NCT02884479|Drug|Docetaxel|Increasing doses of intravenously administered PT-112 in combination with 60 mg/m2 docetaxel every 3 weeks (Q3W) in subjects with advanced solid tumor of any histological type.
16000628|NCT02884128|Drug|LV|5-FU/LV were started after the end of PEP02 infusion on Day 1 and also on Day 8. Treatment repeated every 3 weeks and it was regarded as one cycle of treatment.
16000589|NCT02884466|Behavioral|Multidisciplinary rehabilitation intervention|Both groups will receive examination and medicine adjustment from a rheumatologist, and treatment from physiotherapist, occupational therapist and nursing staff, respectively. The multidisciplinary rehabilitation intervention in both groups will be based on the biopsychosocial model of illness. The inpatient stays of 8-10 hours per day will consist of 1) group tuition, 2) group and individual treatment and 3) unassisted training sessions.
16000590|NCT02884453|Drug|ibrutinib|Ibrutinib (PCI-32765) is a first-in-class, potent, orally-administered, covalently-binding small molecule inhibitor of Bruton's tyrosine kinase (BTK) currently under development for the treatment of B-cell malignancies. Ibrutinib is being co-developed by Janssen Research & Development, LLC and Pharmacyclics Inc.
16000591|NCT02884440|Drug|TAP block ropivacaine|
16000592|NCT02884440|Drug|TAP block placebo|
16000593|NCT02884440|Drug|General anesthesia|Induction PROPOFOL 10mg/ml REMIFENTANIL 50 μg/ml CISATRACURIUM 2mg/ml if necessary DEXAMETHASONE 8 mg KETAMINE 0,15mg/kg Maintenance PROPOFOL 10mg/ml REMIFENTANIL 50 μg/ml
16000594|NCT02884427|Device|Cathode stimulation|Electrical stimulation through the cathode or negative pole, in which a peripheral nerve will be subject to the passage of a direct current seeking increased excitability and conductivity during the passage of current.
16000595|NCT02884427|Device|Anode stimulation|Electrical stimulation through the anode or positive pole, in which a peripheral rib will be subjected to the passage of a direct current seeking to reduce excitability and conductivity during the passage of current.
16000596|NCT02884427|Device|Placebo|Current application without the actual electric conduction to the person occurs. This will be achieved by adjusting parameters while installing another channel and not one that is working.
16000597|NCT02884414|Device|Cutaneous stimulation|A non-invasive external device that will be placed on the leg of the subject. The device consists of a sensing module to determine specific points in the gait cycle, a processor to analyze signal from the sensor, and a stimulus module to provide feedback to the subject.
16000598|NCT02884401|Device|Dental implant placement (Straumann® Bone Level Tapered, BLT, Roxolid® SLActive®)|A tapered bone level implant (Straumann® BLT Roxolid® SLActive®, Basel, Switzerland) will be placed according to the manufactures guidelines trying to achieve primary stability in the correct prosthetic position
16000599|NCT02884388|Procedure|combined nerve block|Patients in this group were assigned to receive lower lumbar plexus block, sciatic nerve block, and paraspinal nerve L1-2 block.
16000600|NCT02884388|Procedure|general anesthesia|Patients in this group were assigned to receive general anesthesia.
16000601|NCT02884375|Other|Extensive GA|"GA includes an evaluation of nine domains according to international recommendations :
~functional status (six-item Activities of Daily Living (ADL) score, Instrumental Activities of Daily Living (IADL))
~mobility (timed get-up-and-go test, one-leg standing balance test, history of fall)
~nutritional status (French National Authority of Health guidelines, weight loss body mass index (BMI), Mini Nutritional Assessment, albumin )
~cognitive status (Mini-Mental State Examination (MMSE), history of dementia, confusion)
~mood (Mini-Geriatric Depression Scale (Mini-GDS), symptoms of anxiety, depression (DSM V))
~comorbidities (CIRS G)
~polypharmacy (number of medications)
~social environment (primary caregiver, support at home, friends , family, living alone)
~urinary and/or fecal incontinence"
16000602|NCT02884362|Other|clinical biological data collection on melanoma|collection and centralization of clinical and biological data of patients with melanoma
16000603|NCT02884349|Procedure|RoM assessment|This group will have a CT scan at three months post-operatively instead of the two radiographs, an anterior/posterior pelvis view and a lateral hip view, which are standard care. They will also have a RoM assessment session in the movement analysis laboratory in the hospital at the same time point lasting about one hour, which is additional to standard care.
16000604|NCT02884336|Other|No intervention|
16000605|NCT02884323|Device|geko™ device|The geko™ (T-2 and R-2) devices are small disposable, internally powered, neuromuscular stimulators that are applied externally to the leg.
16000606|NCT02884310|Drug|Remifentanil adapted to SPI|
16000607|NCT02884310|Drug|Remifentanil fixed|
16000608|NCT02884297|Drug|Contrast agent: SonoVue®.|SonoVue® Injection: will be done through the peripheral venous way already set up by the anesthetist for its injection. None venous dedicated way will be established. The injection will take place when the woman will be under general anesthesia, ventilated and under constant cardio-respiratory monitoring.
16000609|NCT02884284|Other|clinical biological database collection|
16000610|NCT02884271|Procedure|cardiopulmonary resuscitation|start cardiopulmonary resuscitation
16000611|NCT02884245|Drug|Estrogens|The estrogens pretreatment will began between the day 20 and the day 24 of an ovarian cycle and should be continued until Wednesday beyond the onset of menses
16000612|NCT02884232|Procedure|Nasofibroscopy|
16000613|NCT02884219|Drug|Ibuprofen|In the medical treatment (COXi) arm the intention is to close the ductus arteriosus.
16000614|NCT02884219|Other|Expectative Management|Expectative PDA management is characterized as 'watchful waiting'. No intervention is initiated with the intention to close a PDA.
16000615|NCT02884219|Drug|Indomethacin|In the medical treatment (COXi) arm the intention is to close the ductus arteriosus.
16000620|NCT02884193|Procedure|Brief Cooling|Brief Application of cold, for a period of up to 30 seconds on a body surface which seeks to promote the activation of the nervous system to produce increased excitability.
16000621|NCT02884193|Procedure|Prolonged Cold|Prolonged application of cold, for at least 5 minutes or more, on a body surface that aims to reduce nervous system activation by reducing the NCV.
16000622|NCT02884193|Procedure|Sham Ice Bag|"Placebo application through an ice bag empty."
16000623|NCT02884180|Drug|Dexamethasone|A dose of 24 mg dexamethasone given after start of anaesthesia
16000624|NCT02884180|Drug|Saline isotonic|A dose of 6 ml of isotonic saline given after start of anaesthesia
16000625|NCT02884154|Device|Echotip ProCoreⓇ HD Ultrasound Biopsy Needle|
16000635|NCT02884063|Procedure|NGS reading for Media Free DNA|NGS reading for Media Free DNA instead of blstomer biopsy
16000636|NCT02884050|Drug|Topiramate|antiepilepsy drug
16000637|NCT02884050|Drug|Placebo|non-active placebo
16000638|NCT02884037|Drug|Rifaximin group 1|Rifaximin: 1100mg/day, 550 mg tablets 1 × 2 before meals
16000639|NCT02884024|Other|no intervention|there is no intervention in this study
16000640|NCT02883998|Other|Outpatient Physical Therapy|traditional outpatient physical therapy which occurs at a physical therapy office
16000641|NCT02883998|Other|Home Base Physical Therapy|Patients will be provided a packet of exercises via a website which allows access to instructional physical therapy videos specifically designated for UKA patients and equipment to perform the home based physical therapy
16000642|NCT02883985|Radiation|6 Gy/ fraction|"All patients will be treated with 6 Gy (measure of radiation dose) /fraction (each radiation session) delivered in 5 fractions over a 2 week period for a total dose of 30 Gy.
~In addition to routine care, patients may receive antihormonal drugs as part of your base line treatment."
16000643|NCT02883972|Other|Intervention letter|Behavioural-insight informed letter template
16000644|NCT02883972|Other|Control letter|Invitation letter used by local area last year (updated as required)
16000645|NCT02883972|Other|Reminder|Behavioural-insight informed SMS/email reminder message to return consent form
16000646|NCT02883959|Other|music therapy|Music therapy will be delivered through headphones during nursing procedures (toilet and/or surgical dressings): from initiation up to 30 minutes after the end of procedure.
16000647|NCT02883946|Other|Data collection|
16000648|NCT02883933|Other|Data collection|
16000649|NCT02883920|Other|Allergy and respiratory functional tests|
16000650|NCT02883894|Other|Blood sample for dosages of cytokines (IL-17 and IL-23) and of the protease MMP-9|
16000651|NCT02883842|Behavioral|Text messaging|Patients will receive regular semi-personalized text messages for 6 months. Each participants will receive 6 text messages per week, which will be sent at random times of the day (9.00am, 12noon, 4.00pm). They will receive one general messages, one hypertension message, one glucose control message, one lifestyle message, one medication adherence message and one physical activity message per week. Prior to study commencement, a bank of 270 messages have been developed based on guidelines and behavior change theory (BCT), and have underwent multidisciplinary expert review and qualitative review process.
16000652|NCT02883829|Behavioral|Peer-Based Web-Based Health Information|The intervention will be a brief vignette to present educational content about alcohol use risks for Type 1 Diabetes; framed and delivered from a peer-based source. The content for the intervention will be drawn on existing theories of behavior change, including the concepts of 'consciousness raising', 'self-reevaluation' and 'helping relationships'. The intervention will comprise of PowerPoint slides for final implementation as a narrated video that can be posted to a website for participant viewing.
16000653|NCT02883829|Behavioral|Provider-Based Web-Based Health Information|The intervention will be a brief vignette to present educational content about alcohol use risks for Type 1 Diabetes; framed and delivered from a provider-based source. The content for the intervention will be drawn on existing theories of behavior change, including the concepts of 'consciousness raising', 'self-reevaluation' and 'helping relationships'. The intervention will comprise of PowerPoint slides for final implementation as a narrated video that can be posted to a website for participant viewing.
16000654|NCT02883816|Other|assessment of lung function|measurement of lung volumes and flow rates of bronchial
16000655|NCT02883803|Biological|Injection of mesenchymal stem cells|Injection of mesenchymal stem cells
16000656|NCT02883803|Biological|Injection of albumin alone|Injection of albumin alone
16000657|NCT02883790|Dietary Supplement|Somnage|Melatonin 1mg, Zinc, Magnesium
16000658|NCT02883790|Other|Placebo|Placebo
16000659|NCT02883777|Behavioral|High Protein and Low Glycemic Index Diet|It will be evaluated a type of high protein diet with 1,3g/kg/day in kidney transplant recipients over 1 year after transplantation.
16000660|NCT02883777|Behavioral|Conventional Diet|Conventional diet over 1 year after transplantation.
16000661|NCT02883751|Radiation|LED|A device with 36, rectangular, red LEDs, registered with the Brazilian National Health Surveillance Agency (ANVISA authorization nº 8.04554.6), λ = (650 ± 20) nm, with an output power of 324 mW and an output area of 2.54 cm2 (Cosmedical, Brazil), will be enveloped with sterile, disposable, plastic wrap (transparent in the red wavelength) to permit contact with the skin for ten minutes during each session. The plastic wrap will be changed after each use. The amount of energy delivered will be 194.4 J.
16000662|NCT02883751|Procedure|Control group|Conventional ulcer treatment with rayon® (Polar Fix, Polar Fix, Mauá, SP, Brazil) and essential fatty acids (Dersani®, Saniplan, Daudt, São Paulo, SP, Brazil) (composition: decanoic acid, caprylic acid, hexanoic acid, lauric acid, linoleic acid, lecithin, retinyl palmitate, tocopheryl acetate and alpha-tocopheryl).
16000663|NCT02883738|Other|tremor|evaluation of the intensity of the tremor
16000664|NCT02883725|Other|data collection|
16000665|NCT02883699|Behavioral|Standard endurance training|Continuous vigorous training 2 x per week on a cycle ergometer
16000666|NCT02883699|Behavioral|Polarized endurance training|Continuous moderate training 1 x per week and aerobic high intensity interval training (HIIT) 1 x per week on the cycle ergometer
16000667|NCT02883699|Behavioral|Standard resistance training|Machine based hypertrophy training 2 x per week
16000668|NCT02883699|Behavioral|Daily undulating periodization resistance training|Machine based daily undulating periodization resistance training 1 x per week
16000669|NCT02883686|Behavioral|Alma|Alma peer-mentoring
16000670|NCT02883673|Device|Jada System|It is a teardrop-shaped, soft silicone ring that is placed into the uterus, where gentle suction is applied to cause the uterus to contract and shrink in size, compressing the blood vessels so the bleeding stops.
16000671|NCT02883660|Genetic|Genocept Assay|battery of pharmacogenetic tests relevant to psychiatry
16000672|NCT02883647|Drug|Entecavir or Tenofovir|Patients in retreatment group receive nucleos(t)ide analogs therapy (Entecavir 0.5mg/d or Tenofovir 300mg/d) again
16000673|NCT02883634|Other|Specific manipulation|Patients allocated to the specific manipulation group will receive spinal manipulation according to the physical examination performed prior to the treatment allocation.
16001434|NCT02877797|Device|Cap|cap assisted esophagogastroduodenoscopy
16071125|NCT02374567|Drug|Flurazepam|
16000674|NCT02883634|Other|Non-specific manipulation|Patients allocated to the specific manipulation group will receive spinal manipulation on the upper thoracic spine that will be not related to the physical examination performed prior to the treatment allocation.
16000675|NCT02883621|Procedure|cap assisted upper endoscopy|A soft plastic cap is attached to the tip of the scope to allow pressing of the folds and thus enhance the visualization.
16000676|NCT02883621|Procedure|standard upper endoscopy|standard examination without using a cap
16000677|NCT02883608|Procedure|cap assisted forward-viewing endoscope|a cap fitted to the to top of the forward-viewing endoscope
16000678|NCT02883595|Drug|thymosin alpha 1|Subcutaneous injections of 1.6 mg thymosin alpha 1 twice per day for seven days, prior to administration, the lyophilized powder is to be reconstituted with 1 ml of the provided diluent.
16000679|NCT02883595|Other|Placebo|Subcutaneous injections of placebo (saline) twice per day for seven days
16000680|NCT02883582|Device|oxyhydrogen|Hydrogen/oxygen mixed gas inhaled(proportion 2:1),3 L/min . 1 hour each time,twice a day(BID).Test Duration is three months.
16000681|NCT02883582|Device|oxygen|oxygen inhaled,3 L/min . 1 hour each time,twice a day(BID).Test Duration is three months.
16000682|NCT02883569|Procedure|open or endoscopic discectomy|FDA approved surgical procedures
16000683|NCT02883569|Procedure|epidural block|epidural block
16000684|NCT02883569|Other|exercise|educated exercise
16000685|NCT02883569|Drug|ibuprofen, naxoprofen, Cox-2 inhibitor, aceclofenac|FDA approved medication such as ibuprofen, naxoprofen etc.
16000686|NCT02883569|Procedure|decompression|FDA approved surgical procedure such as lamiectom and, laminotomy
16000687|NCT02883569|Procedure|instrumentation and fusion|FDA approved surgical procedure such as PLIF, ALIF, DLIF, OLI and TLIF
16000688|NCT02883569|Drug|codeine, oxycontine, IRcodone, Tramadol|FDA approved opioid drug such as codeine, oxycontin, IRcodon
16000689|NCT02883569|Procedure|epidural adhesiolysis|FDA approved epidural adhesiolysis with catheter or endoscope
16000690|NCT02883556|Drug|Pembrolizumab|200 mg, administered as intravenous (IV) infusion every 3 weeks up to 24 months or until progression or unacceptable toxicity develops.
16000691|NCT02883543|Drug|icotinib|Icotinib is orally administered three times per day.
16000692|NCT02883543|Drug|Chemotherapy|"Chemotherapy is given by intravenous administration. Three regimens are available in this study.
~Regimen 1: etoposide 75mg/m2 d1-5 + cisplatin 75 mg/m2 day1/ day1-2.
~Regimen 2: docetaxel 75mg/m2 d1 + cisplatin 75 mg/m2 day1/ day1-2.
~Regimen 3: pemetrexed 500mg/m2 d1 + cisplatin 75 mg/m2 day1/ day1-2"
16000693|NCT02883543|Radiation|Radiotherapy|5Gy/75.00Gy, 10f/2w for peripheral lung cancer, and 2.4Gy/59.52Gy, 20f/4w for central lung cancer.
16000694|NCT02883530|Procedure|Bronchoscopy|Flexible bronchoscopy will be performed under conscious sedation (with premedication using a mild sedative such as 1-2.5 mg IV midazolam) followed by use of topical anaesthesia (lidocaine spray) on the throat, vocal cords, and trachea in order to investigate the airways. The procedure allows sampling of the airway tissue to allow for laboratory analysis. Three brushings of a small area of the epithelial surface of an airway will be performed via a specialised channel of the bronchoscope with the use of a sterile cytology brush and up to eight 2-mm endobronchial biopsies.
16000695|NCT02883517|Genetic|Cytogenetic and molecular studies|Detect cell-free circulating tumoral DNA in a blood sample, with correlations with clinical characteristics and metastatic outcome.
16000696|NCT02883504|Procedure|Echo-Doppler examination and left heart catheterization|
16000697|NCT02883478|Device|UV-X 1000 (3 mW/cm²)|Ultraviolet-A (UVA) irradiation for 30 minutes at 3 milliwatt/cm² (mW/cm²).
16000698|NCT02883478|Procedure|UV-X 2000 (9 mW/cm²)|Ultraviolet-A (UVA) irradiation for 10 minutes at 9 mW/cm².
16000699|NCT02883478|Drug|riboflavin with hydroxypropyl methylcellulose|Drops of riboflavin with hydroxypropyl methylcellulose will be applied in the eye for 20 minutes before ultraviolet-A(UVA) irradiation and every 2 minutes during UVA irradiation
16000700|NCT02883465|Procedure|Diaphragmatic ultrasound|"All patients will have a diaphragmatic ultrasound in the 4 hours before the extubation.
~a record of the right and left diaphragmatic cupolas run, with a chest approach and using a 4-5 MHz (megahertz) cardiac or abdominal sensor. 3 acquisitions for each side
~a record of the diaphragm thickening at the right and left apposition zones with a 10-12 MHz (megahertz) vascular sensor. 3 acquisitions for each side"
16000701|NCT02883452|Biological|CT-P13|CT-P13 (5 mg/kg) by IV infusion administered as a 2-hour IV infusion per dose every 8 weeks (Part 1)
16000702|NCT02883452|Biological|CT-P13|CT-P13 (120 mg) by single SC injection every 2 weeks (Part 1)
16000703|NCT02883452|Biological|CT-P13|CT-P13 (180 mg) by double SC 90 mg injections every 2 weeks (Part 1)
16000704|NCT02883452|Biological|CT-P13|CT-P13 (240 mg) by double SC 120 mg injections every 2 weeks (Part 1)
16000705|NCT02883452|Biological|CT-P13|CT-P13 (120 mg) by single SC injection every 2 weeks in patients with body weight less than 80 kg, and CT-P13 (240 mg) by double SC 120 mg injections in patients with body weight at or above 80 kg based on body weight at Week 6 (Part 2)
16000706|NCT02883452|Biological|CT-P13|CT-P13 (5 mg/kg) by IV infusion administered as a 2-hour IV infusion per dose every 8 weeks up to Week 22. From Week 30, CT-P13 (120 mg) by single SC injection every 2 weeks in patients with body weight less than 80 kg, and CT-P13 (240 mg) by double SC 120 mg injections in patients with body weight at or above 80 kg based on body weight at Week 30 (Part 2)
16000707|NCT02883439|Drug|MP29-02|local nasal application
16000708|NCT02883439|Drug|Fluticasone propionate|local nasal application
16000709|NCT02883426|Biological|H3N2v MN 2010/AA ca live attenuated influenza vaccine (LAIV)|Approximately 10^7.0 Fluorescent Focus Units (FFU) per 0.2 mL dose; administered intranasally
16000710|NCT02883426|Biological|H3N2v inactivated subvirion influenza vaccine|15 μg; administered intramuscularly
16000711|NCT02883426|Biological|Placebo|Administered by nasal spray
16000712|NCT02883413|Behavioral|CRT + Teach the Parent|CRT sessions will occur for 45-60 minutes every day (excluding weekends) for 6-8 days while adolescents are in hospital. Adolescents will be given homework and asked to practice tasks each day.
16000713|NCT02883413|Behavioral|CRT + Contact Control|Adolescents will be asked to spend 3-4 sessions with their parents engaging in fun activities (games, coloring, trivia). Adolescents will be able to choose 2 tasks from a list and be asked to engage in those tasks with their parents.
16000714|NCT02883400|Drug|Spironolactone|spironolactone 25 mg up to 50 mg
16000715|NCT02883387|Other|Preoperative CT angiography|Patients will receive a CT scan to map the blood vessels to be used during surgery for breast reconstruction
16000716|NCT02883387|Other|No Preoperative Imaging|No imaging will be done to map blood vessels prior to surgery
16000717|NCT02883374|Drug|Chidamide|
16000718|NCT02883361|Behavioral|Motivational enhancement therapy|Counseling meant to enhance motivation and decrease ambivalence about change, including asking open-ended questions, eliciting change-talk, and identifying discrepancies between current behaviour and valued behaviour
16000719|NCT02883361|Behavioral|Attention Control|Having participants come into the lab and fill out questionnaires with a researcher in-person
16000720|NCT02883335|Other|Observational registry|
16000721|NCT02883322|Other|Cross cultural adaptation of patient reported outcomes (PRO)|Process used to adapt a questionnaire from one cultural setting to another
16000722|NCT02883309|Other|intradialytic physical training program|Nine patients participated in the experimental group in a combined training program, which lasted 12 weeks with a frequency of 3 times a week, the training sessions were carried out within each dialysis session during the first 2 hours of the dialysis treatment, the working session involved a warm up period, aerobic exercise with pedals, or strength exercises based on free weight depending on the training stage. The Borg scale and the heart rate reserve were used to control the training intensity. The disability level was evaluated at the beginning and the end of the study through the World Health Organization Disability Assessment Schedule II, the aerobic capacity was evaluated through the six minute walk and the limbs strength was evaluated through a dynamometer.
16000723|NCT02883296|Other|Pelvis Magnetic resonance imaging|
16000724|NCT02883283|Procedure|Epidural loading dose|Labor epidural analgesia loading dose
16000725|NCT02883283|Device|Epidural catheter|Epidural loading dose via epidural catheter
16000726|NCT02883283|Device|Epidural needle|Epidural loading dose via epidural needle
16000727|NCT02883270|Device|Robot-assisted Gait Training|Robot-assisted Gait Training is an effective alternative to treadmill therapy with partial body weight in intense gait rehabilitation and provided to the feet and the patient actively controls the knee and hip joints.
16000728|NCT02883270|Other|conventional rehabilitation|The participants of controls receive 60 min conventional rehabilitation daily for 8 weeks. Interventions included physiotherapy for muscle strengthening, endurance and gait training; occupational therapy to improve activity of daily living (domestic, community tasks).
16000729|NCT02883257|Behavioral|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy will include core mandatory modules of key effective components (e.g., behavioural activation, cognitive restructuring) and optional elements to address individual maintaining factors (e.g., coping and social skills training, perfectionism and self-criticism).
16000730|NCT02883244|Device|Soft-Picks Advanced|Soft-picks Advanced will be used once a day to clean interdental sites at home.
16000731|NCT02883244|Device|Floss|Floss will be used once a day to clean interdental sites at home.
16000732|NCT02883231|Other|taking peripheral blood|taking peripheral blood of no more than 3ml
16000733|NCT02883192|Drug|Ondansetron|Zofran 4 mg.
16000734|NCT02883192|Drug|Placebo|Placebo
16000735|NCT02883179|Drug|lidocaine injection|anhydrous solution
16000736|NCT02883179|Drug|lidocaine-prilocaine cream|topical cream
16000737|NCT02883166|Drug|abiraterone|integested with a continental breakfast
16000738|NCT02883153|Drug|Zirconium-89 girentuximab PET/CT|Thirty patients (suspected of ccRCC) will be included in whom conventional diagnostics are inconclusive. During a multidisciplinary team (MDT) the hypothetical next step in the clinical process will be noted. Subsequently, in these patients a Zirconium-89-girentuximab PET/CT will be performed 4-5 days after single intravenous injection of 5 mg Zirconium-89-girentuximab (37 MBq). The results of the PET/CT will be discussed during the MDT and will be used to decide what the next step in the clinical process will be. This step will be compared with the hypothetical next step from the MDT before the scan. Whether or not the PET/CT scan had impact on clinical decision making will be assessed for each individual patient.
16000739|NCT02883140|Other|Three-dimensional sialography CBCT and MRI sialography|"MRI sialography: Achieved on a 3 Tesla MRI (INGENA 3T Philips Medical Systems). Patient supine positioned. Sialo-MR sequences (3D T2 DRIVE, TSE, SENSE and SPIR) and conventional sequences (T2 turbo spin echo).
~3D CBCT sialography: Achieved same day as the MRI sialography, after acute episode subsided. 0.5ml of high concentration, water-soluble, iodinated contrast product (HEXABRIX 320®, 320g /L, Guerbet, France) is injected in the symptomatic salivary gland and maintained in the gland. Image acquisition performed on a wide-field CBCT device (NewTom VGi, QR, Verona, Italy). Front and profile scout views achieved. mA and exposure time modulated according to scout views. Reconstruction in Maximal Intensity Projection, 3-dimensional and MultiPlanar Reconstructions sections"
16000740|NCT02883127|Behavioral|Motivational interviewing|"The aim is to provide a one-to-one contact every second week of approximately 10 minutes duration. An action plan for improving dietary behavior will be made during the first session and evaluated in subsequent sessions. The following dietary objectives will be set for each participant to achieve or to maintain:
~Watch portion size - to be conscious about the amount of carbohydrates in each meal.
~Eat mainly carbohydrates of low glycaemic index.
~Reduce the intake of carbohydrate of high glycaemic index.
~Watch daily weight changes - aim for the recommended weekly changes.
~In addition to the motivational intervention the women are given unchanged routine care."
16000741|NCT02883114|Drug|PF-06648671|Subjects will receive a single dose of PF-06648671 25 mg oral suspension on day 1 in period 1 and a single dose on Day 4 in period 2.
16000742|NCT02883114|Drug|Itraconazole|Subjects will receive itraconazole 200 mg oral solution once a day for 14 days in period 2
16000743|NCT02883101|Behavioral|Pulmonary Rehabilitation|"The Rehabilitation Programme will include the following :
~i. Patient education ii. Exercise training iii. Ventilator and breathing exercises"
16000744|NCT02883088|Procedure|Frequency Domain - Optical Coherence Tomography (FD-OCT)|FD-OCT assessment of the native proximal-mid left descending artery during clinically indicated coronary angiography
16000745|NCT02883075|Other|Supine position|Spinal anesthesia in sitting position then 2 minutes in Supine position after spinal anesthetic administration
16000746|NCT02883075|Other|Right lateral position|Spinal anesthesia in sitting position then 2 minutes in the right lateral position after spinal anesthetic administration
16001480|NCT02877485|Drug|Triamcinolone Acetonide|2 sprays sprayed to both nostrils daily for 42 days.
16000747|NCT02883075|Other|Left lateral position|Spinal anesthesia in sitting position then 2 minutes in the left lateral position after spinal anesthetic administration
16000748|NCT02883062|Drug|Atezolizumab|Given IV
16000749|NCT02883062|Drug|Carboplatin|Given IV
16000750|NCT02883062|Procedure|Lumpectomy|Undergo lumpectomy
16000751|NCT02883062|Procedure|Mastectomy|Undergo mastectomy
16000752|NCT02883062|Drug|Paclitaxel|Given IV
16000753|NCT02883049|Drug|Clofarabine|Given IV
16000754|NCT02883049|Drug|Cyclophosphamide|Given IV
16000755|NCT02883049|Drug|Cytarabine|Given IT, IV, or SC
16000756|NCT02883049|Drug|Dasatinib|Given PO
16000757|NCT02883049|Drug|Daunorubicin Hydrochloride|Given IV
16000758|NCT02883049|Drug|Dexamethasone|PO or IV
16000759|NCT02883049|Drug|Doxorubicin Hydrochloride|Given IV
16000760|NCT02883049|Drug|Etoposide|Given IV
16000761|NCT02883049|Drug|Hydrocortisone Sodium Succinate|Given IT
16000762|NCT02883049|Other|Laboratory Biomarker Analysis|Correlative studies
16000763|NCT02883049|Drug|Leucovorin Calcium|Given PO or IV
16000764|NCT02883049|Drug|Mercaptopurine|Given PO
16000765|NCT02883049|Drug|Methotrexate|Given IT and IV
16000766|NCT02883049|Drug|Pegaspargase|Given IV
16000767|NCT02883049|Drug|Prednisone|Given PO or IV
16000768|NCT02883049|Radiation|Radiation Therapy|Undergo radiation therapy
16000769|NCT02883049|Drug|Thioguanine|Given PO
16000770|NCT02883049|Drug|Vincristine Sulfate|Given IV
16000771|NCT02883036|Other|blood sampling|sampling after diagnosis and the mononuclear cells will be given tigecycline stimulation in vitro
16000772|NCT02883036|Other|blood sampling|sampling after register and the mononuclear cells will be given tigecycline stimulation in vitro
16000773|NCT02883023|Other|Electrosclerotherapy|Combination of intralesional bleomycin sclerotherapy and electroporation
16000774|NCT02883023|Drug|Intralesional bleomycin injection|Local intralesional injections with bleomycin
16000775|NCT02883010|Device|PICO Softport V1.6|PICO is a Single-Use Negative Pressure Wound Therapy (NPWT) System consisting of a small portable pump, 2 lithium batteries, 2 dressings and fixation strips. The system is capable of delivering up to 80 mm Hg negative pressure to a wound or surgical incision site and managing low to moderate levels of exudate or fluid generated by the wound or incision. The therapy may be administered for up to 2 weeks.
16000776|NCT02883010|Other|Standard Care|Care path normally used by the hospital
16000777|NCT02882997|Behavioral|an interactive computer game|Duck Duck Punch is an interactive computer game designed to elicit repetitive practice of paretic arm movements in stroke patients.
16000778|NCT02882997|Behavioral|standard activities|For community dwelling stroke survivors this is a hard copy, written/illustrated home exercise program for the paretic arm. For inpatient stroke patients this is standard recreational activities organized by the facility during non therapy hours (evenings and weekends).
16000779|NCT02882984|Drug|Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid Other Name: Gefitinib/Tarceva/Icotinib|radiation given along with one of kind TKI
16000780|NCT02882984|Radiation|WBRT|3750 cGy in 15 fractions given within 3 weeks time.
16000781|NCT02882984|Radiation|HFSRS|All HFSRS given in 5 fractions. dose per fraction ranges from 5 to 8 Gy depending on the target volume and organs at risk tolerance.
16000782|NCT02882971|Behavioral|Pain Assessment|To create an objective observational pain scoring system and validate.
16000783|NCT02882945|Other|Group A|150 healthy blood donors without a family history of diabetes mellitus were enrolled in the study.
16000784|NCT02882945|Other|Group B|200 cases of type 2 DM without complications were enrolled in the study.
16000785|NCT02882945|Other|Group C|120 cases of type 2 DM with macroangiopathy complication were enrolled in the study.. Among the group C subjects, 65 individuals had CHD; 55 patients had cerebrovascular disease (CVD); and 30 subjects had a combination of peripheral vascular diseases (PVD) and CHD.
16000786|NCT02882932|Procedure|Super Oxidized Solution in group I|Two groups were made as group I and group II. Peritoneal Lavage was given with SOS and normal saline in group I. in group II only normal saline wash was given.
16000787|NCT02882919|Behavioral|Check Yourself v2.0|In the intervention group, adolescents complete Check Yourself which delivers personalized, motivational feedback on their health behaviors prior to their primary care appointment. Key components of Check Yourself include the provision of age normative feedback, goal setting strategies, and strategies to increase motivation for healthy behaviors. Primary care providers will receive a summary report of health risk behaviors prior to their adolescent patient's primary care appointment.
16000788|NCT02882893|Drug|Clostridium Botulinum A Toxin|
16000789|NCT02882893|Drug|Clostridium Botulinum A Toxin|
16000790|NCT02882880|Device|The Luco Hybrid OSA Appliance|Group 1, initial treatment with the device, reassessed at 14 and 60 days, Group 2, removal of the treatment for 48 hours, to determine if relapse occurs, retested at 60 days with the device (recovery from intervention).
16000791|NCT02882867|Other|Injuries in Swedish Youth Athletics. The KLUB-study.|
16000792|NCT02882854|Drug|Guanfacine|Patients will receive 1 mg of guanfacine to take orally.
16000793|NCT02882854|Drug|Placebo|Patients will receive a placebo containing no drug that appears similarly to guanfacine to take orally.
16000794|NCT02882841|Other|Biopsies, stool and blood collection|
16000795|NCT02882828|Drug|switched from Prograf® to Envarsus®|
16000796|NCT02882815|Device|IrisFIT PFO Occluder|
16000797|NCT02882802|Behavioral|Mindfulness Based Stress Reduction|Mindfulness Based Stress Reduction (MBSR) is a group-based intervention in which participants are taught different mindfulness meditation practices, including body scan (focusing attention to different areas of the body in sequence), sitting meditation (focusing attention to one's breathing), and Hatha yoga postures (focusing attention to different body sensations during gentle stretching). Participants also are taught how to practice mindfulness while engaging in ordinary activities including walking, standing, and eating. MBSR consists of 8, two-hour weekly sessions and will be delivered in group format. MBSR groups will be delivered virtually.
16000832|NCT02882555|Drug|Normal saline|A compressed air-driven nebuliser is controlled by a dosimeter and a valve is used to deliver similar inspiratory flows for 400 msec in children and 1200 msec in adults.
16071126|NCT02374567|Drug|Nitrazepam|
16000798|NCT02882802|Behavioral|Trauma Recovery Education Class|Trauma Recovery Education Class (TREC): TREC is a group based treatment that focuses on providing information on PTSD and traumatic reactions. TREC provides psycho-education to Veterans on PTSD, including common reactions to trauma and the role of avoidance, common problems associated with PTSD, as well as common barriers to care (e.g., stigma, maladaptive beliefs, fear). Additional content focuses on problem identification and goal setting, discussion of current problems and life issues, and treatment planning. TREC consists of 8, one-hour weekly sessions. TREC groups will be delivered virtually.
16000799|NCT02882789|Drug|LCB01-0371|Cohort1 & 3: Placebo-controlled, Single ascending dose administration
16000800|NCT02882789|Drug|LCB01-0371 400mg|Cohort 2: Crossover designed administration
16000801|NCT02882776|Dietary Supplement|Ginger drink|Ginger powder dissolved in water
16000802|NCT02882763|Other|Parents As Teachers (PAT)|A trained PAT parent educator (pediatric nurses in this study) visits families at their homes, approximately two times a month (individual frequencies may vary depending on specific risk factors) until the children are three years old. PAT is an educational home visitation program that aims to a) help parents to understand child developmental aspects and improve their parenting skills, b) detect developmental shortcomings, c) prevent child abuse and neglect, and d) enhance school preparedness. Additionally, the project offers monthly group meetings.
16000803|NCT02882750|Other|EORTC QLQ-C30 (version 3.0).|Quality of Life Questionnaire
16000804|NCT02882750|Other|PS Q18|Patients Satisfaction Questionnaire
16000805|NCT02882750|Other|Decision Self-Efficacy Scale|Questionnaire
16000806|NCT02882737|Drug|Glucagon before exercise|
16000807|NCT02882737|Drug|Glucagon after exercise|
16000808|NCT02882737|Drug|Glucagon after resting|
16000809|NCT02882724|Behavioral|Exercise|8-week aquatic exercise training program
16000810|NCT02882724|Behavioral|Control|Control group did not do the exercise training.
16000811|NCT02882711|Drug|Ketamine|Ketamine will be infused (slow IV infusions of ketamine (0.5 mg/kg) over 40 minutes) twice weekly over a period of 4 weeks and weekly for the following 4 weeks of the study treatment period (8 weeks total).
16000812|NCT02882698|Behavioral|Down Syndrome Group 1|Acquisition and retention phase on maze A, transfer on maze B and C.
16000813|NCT02882698|Behavioral|Down Syndrome Group 2|Acquisition and retention phase on maze C, transfer on maze A and B.
16000814|NCT02882698|Behavioral|Typical Development Group 1|Control group. Acquisition and retention phase on maze A, transfer on maze B and C.
16000815|NCT02882698|Behavioral|Typical Development Group 2|Control group. Acquisition and retention phase on maze C, transfer on maze A and B.
16000816|NCT02882685|Procedure|Roux-en-y gastric bypass|
16000817|NCT02882685|Procedure|Single anastomosis gastric bypass|
16000818|NCT02882672|Other|Experimental|Doing exercise at 60-85% of maximal heart rate, lasted 45-60 minutes and included a 10-minute warm-up, 40 minutes of aerobic exercises, consisting of stationary cycling, walking and/or jogging
16000819|NCT02882672|Other|Control|They did not do ant exercise training during 8 weeks.
16000820|NCT02882659|Biological|Dendritic Killer Cell (DKC)|DKC is a hybrid cell type capable of dual functionality, i.e. cytotoxicity and antigen presentation, similar to NK cells and DCs, respectively.
16000821|NCT02882646|Device|Bi-ADLER|Subjects will be asked to use the Bi-ADLER for 60 minutes. All subjects will be seated on the Bi-ADLER and asked to perform a battery of bimanual evaluation tasks (creating ovals, standard ADL tasks like pouring, reaching, drinking etc).
16000822|NCT02882633|Drug|30ml bolus of bupivacaine|Local anesthetic
16000823|NCT02882620|Behavioral|High Intensity (Group 1)|The high intensity intervention includes: navigated outreach, with four in-depth education outreach sessions; mailed FIT; education material; and follow-up mailed reminders (Group 1). The navigated outreach includes one-on-one information dissemination about CRC, importance of adhering to CRC screening guidelines, identification and solutions to screening barriers, motivation, self-efficacy and comprehension on how to complete the FIT kit, and gathering (if requested) and return of the completed FIT to the laboratory. The educational material (brochure) is specially developed and culturally tailored for the six Tribes recruited for this study. The FIT kit used is the Polymedco OC FIT-CHECK® OC-Light test, which is a single collection test that meets USPSTF's guidelines.
16000824|NCT02882620|Behavioral|Medium Intensity (Group 2)|The medium intensity intervention includes: mailed FIT; education material; and follow-up mailed reminders (Group 2). The educational material (brochure) is specially developed and culturally tailored for the six Tribes recruited for this study. The FIT kit used is the Polymedco OC FIT-CHECK® OC-Light test, which is a single collection test that meets USPSTF's guidelines.
16000825|NCT02882620|Behavioral|Reference Group (Group 3)|The reference group (Group 3), per IHS guidelines and current standard of care at participating IHS facilities, receives usual care (ie, screening recommendation and a FIT kit at a clinic visit). The FIT kit used is the Polymedco OC FIT-CHECK® OC-Light test, which is a single collection test that meets USPSTF's guidelines.
16000826|NCT02882607|Behavioral|Mzanga Samala Moyo Wako ([Mzanga] Peer Groups|8 small group sessions led by community young women, focused on reproductive health, including HIV, STI and unintended pregnancy prevention; includes skill-building for self-efficacy
16000827|NCT02882594|Behavioral|Observing patient behaviors for anesthesia induction compliance|Observing patient behaviors for anesthesia induction compliance so to test reliability and validity of the CIBA Tool
16000828|NCT02882581|Radiation|11C-metformin|400MBq of 11C-metformin is injected in the cubital vein. The participant is then scanned for 120 min using Position Emission Tomography.
16000829|NCT02882568|Biological|blood analysis|Pilot study, single center, interventional including 15 obese subjects with acute sepsis. Inflammatory and immunological tests during acute phase and one month later after a presumed return parameters at baseline
16000830|NCT02882555|Behavioral|Exercise|6 min running on a motor-driven tredmill in a climate room (18-20°C, humidity <10 mg/l). Tredmill speed and slope are adjusted to increase heart rate to about 80 % of maximum value predicted for age (= 210 - age in years) during the first 2-3 min and pursued until the end of exercise (3-4 min). Heart rate is measured during the whole exercise.
16000831|NCT02882555|Drug|Capsaicin|A compressed air-driven nebuliser is controlled by a dosimeter and a valve is used to deliver similar inspiratory flows for 400 msec in children and 1200 msec in adults.
16001688|NCT02875886|Drug|Hydrochlorothiazide|Combined with amiloride
16000833|NCT02882542|Other|Visible light exposure|Subjects will be exposed to visible colored light for 15 minutes. The visible light will be generated by red-green-blue light emitting diodes light cans.
16000834|NCT02882529|Other|Visible light exposure|Subjects will be exposed to visible colored light for 15 minutes. The visible light will be generated by red-green-blue light emitting diodes light cans.
16000835|NCT02882516|Other|Visible light exposure|Subjects will be exposed to visible colored light for 15 minutes. The visible light will be generated by red-green-blue light emitting diodes light cans.
16000836|NCT02882503|Device|endoscopic ultrasound - radiofrequency ablation (EUS-RFA)|Radiofrequency ablation will be applied with an innovative monopolar radiofrequency probe (1.2 mm Habib EUS-RFA catheter) placed through a 19 or 22 gauge fine needle aspiration (FNA) needle in patients with a tumor in the head of the pancreas.
16000837|NCT02882490|Behavioral|Parent Training|
16000838|NCT02882490|Other|Supportive Therapy|
16000839|NCT02882477|Drug|Deferiprone|
16000840|NCT02882477|Drug|Acetylcysteine|
16000841|NCT02882477|Drug|Sitagliptin and Metformin|
16000842|NCT02882464|Device|PC-02 Centrifuge device,2PRF+CAF|In 2PRF+CAF group two layers of stacked PRF membranes were positioned over the recession area at the level of cemento-enamel junction(CEJ). In CAF+2PRF group,two layers of stacked PRF membranes were positioned over the recession area at the level of CEJ
16000843|NCT02882464|Device|PC-02 Centrifuge device, 4 PRF+CAF|Following this, in test groups, a horizontal sulcular incision was designed at the buccal side of recession area at the level of CEJ. The incision was extended in the interdental area to be connecting CEJ. A split thickness flap was raised without vertical incision.18 The papillae were disepithelialized. The root was planned and hard accumulations were removed but no chemical root treatment was performed. In test group-1, two layers of stacked PRF membranes were positioned over the recession area at the level of CEJ. In test group-2, four layers of stacked PRF membranes were positioned over the recession area at the level of CEJ (Figure 2). Membranes were sutured to the recipient bed by a resorbable suture (polyglycolic acid 6/0, Doğsan, Turkey) at the level of CEJ.
16000844|NCT02882464|Procedure|CTG+CAF|The connective tissue graft was sutured to the recipient bed by resorbable suture at the level of CEJ. Split thickness flap was coronally advanced and sutured by resorbable suture. Finally, periodontal dressing was fixed on the recipient surgical area.
16000845|NCT02882451|Dietary Supplement|pinaverium bromide|
16000846|NCT02882451|Dietary Supplement|Vitamin C|
16000847|NCT02882438|Drug|infected group|Ginkgo Biloba in different dosage forms
16000848|NCT02882438|Drug|control group|placebo without Ginkgo Biloba
16000849|NCT02882425|Drug|Selexipag for intravenous use|Selexipag was reconstituted in sterile 0.9% w/v NaCl before infusion via an infusion pump at a rate of 2.5 µg/min.
16000850|NCT02882425|Drug|Selexipag for oral use|Tablet containing 200 µg of selexipag
16000851|NCT02882412|Other|observational|
16000852|NCT02882399|Other|Shortystrap|
16000853|NCT02882386|Other|Strength Training|
16000854|NCT02882386|Dietary Supplement|Milk 1%|
16000855|NCT02882386|Dietary Supplement|Whey protein concentrate 80 (WPC-80)|
16000856|NCT02882386|Dietary Supplement|Microparticulated whey|
16000857|NCT02882386|Dietary Supplement|Hydrolyzed whey|
16000858|NCT02882386|Dietary Supplement|Native whey|
16000859|NCT02882373|Dietary Supplement|Arginine|Given PO
16000860|NCT02882373|Drug|Placebo|Given PO
16000861|NCT02882360|Device|Kerlix-AMD|Application of PHMB impregnated gauze pre-operatively (for booked C-sections) and post-operatively for all patients with LSCS. Gauze to be changed daily or more frequently if damp/blood-tinged
16000862|NCT02882360|Other|placebo--normal gauze|Application of gauze pre-operatively (for booked C-sections) and post-operatively for all patients with LSCS. Gauze to be changed daily or more frequently if damp/blood-tinged
16000863|NCT02882347|Drug|Somatostatin|
16000864|NCT02882334|Device|Finger Force Manipulandum|
16000865|NCT02882334|Other|Conventional physiotherapy|
16000866|NCT02882321|Drug|Oxidative Phosphorylation Inhibitor IACS-010759|Given PO
16000867|NCT02882321|Other|Pharmacological Study|Correlative studies
16000868|NCT02882308|Drug|Olaparib|50/25 mg BD split x 5 days
16000869|NCT02882308|Drug|Cisplatin|60 mg/m^2 d1-d5
16000870|NCT02882308|Drug|Olaparib|300 mg BD x 21-28 days.
16000871|NCT02882308|Drug|Durvalumab|1500 mg d1
16000872|NCT02882295|Other|Validation of a handwriting scale|
16000873|NCT02882282|Other|Laboratory Biomarker Analysis|Correlative studies
16000874|NCT02882282|Other|Patient Observation|Undergo observation
16000875|NCT02882282|Biological|Pembrolizumab|Given IV
16000876|NCT02882269|Drug|Postoperative chemotherapy|Locally advanced colon cancer patients will receive surgery first, followed by 6 months of chemotherapy. The recommended chemotherapy regimes includes FOLFOX, CapeOX, FOLFIRI, Capecitabine monotherapy.
16000877|NCT02882269|Drug|Neoadjuvant chemotherapy|Neoadjuvant chemotherapy will be given to locally advanced colon cancer patients for 3-4 cycles. Surgery will be performed between 3 to 4 weeks subsequent to the last cycle of chemotherapy. After surgery, additional chemotherapy will be given. Preoperative and postoperative chemotherapy will be given for a total of 6 months. The recommended chemotherapy regimes includes FOLFOX, CapeOX, FOLFIRI, Capecitabine monotherapy.
16000878|NCT02882256|Other|Video discharge instructions|Discharge instructions provided in video form
16000879|NCT02882243|Device|FLXfit Cage for fusion|Evaluating patient outcomes and radiographic outcomes
16000880|NCT02882230|Drug|prescription of at least one of the following drugs: rilpivirine, elvitegravir, dolutegravir|chemical dosage ARV
16000881|NCT02882217|Drug|XC8 (histamine glutarimide)|
16000882|NCT02882217|Drug|Placebo|
16000883|NCT02882191|Drug|LevoCept|placement of LevoCept IUD
16000956|NCT02881528|Drug|Placebo|Liquid formula of placebo administered by oral syringe in an equivalent volume to a metformin dose of 10mg/kg body weight once daily for 2 weeks, then to 10mg/Kg twice daily (maximum 500mg twice daily) for a further two weeks during the first month, increasing to 20mg/kg body weight twice daily (maximum 1000mg twice daily) thereafter.
16000957|NCT02881515|Other|Low Sodium Diet|Ten days of low sodium diet
16000958|NCT02881515|Other|Medium Sodium Diet|Ten days of a medium sodium diet
16000884|NCT02882165|Other|Medical review|"A personalised, medical review will be conducted by a respiratory-trained Clinical Fellow. The Clinical Fellow will address any changes needed to optimise their lung health, any comorbidities and social situation. Education will be provided with regards to the COPD diagnosis, identifying and treating exacerbations, inhaler technique, smoking cessation and nutrition. The review will ensure any secondary prevention needs have been addressed and suggest onward referral to other services in primary or secondary care as the patient requires.
~A follow up appointment will be booked during the initial appointment; to take place four to eight weeks later to identify and act upon any new clinical issues relevant to the patient's COPD and to follow up any clinical issues previously identified"
16000885|NCT02882152|Procedure|femoral nerve blockade|"femoral nerve blockade followed by a catheter placement for continuous infusion and a single shot block of the sciatic nerve at the end of the surgery"
16000886|NCT02882152|Procedure|morphine|Intrathecal morphine injection
16000887|NCT02882126|Drug|Subcutaneous Treprostinil|Remodulin (1.0, 2.5, 5 and 10 mg/ml formulations as available) will be administered by continuous subcutaneous infusion via a subcutaneous cannula using a microbore infusion tubing set and a micro infusion pump.
16000888|NCT02882113|Drug|Advagraf|same dose as Tacrolimus bid der day in 24 weeks
16000889|NCT02882100|Biological|adjuvanted trivalent influenza vaccine|Nursing home residents over 65 years are allocated to receive adjuvanted trivalent vaccine. Residents under 65 years are provided standard trivalent vaccine (TIV-Fluvirin).
16000890|NCT02882100|Biological|trivalent influenza vaccine|Nursing home residents are allocated to receive standard trivalent vaccine (TIV).
16000891|NCT02882087|Drug|Placebo plus MTX|All patients had a foundation MTX therapy.The researchers evaluated the efficacy of the patient in 12 week.study investigator evaluate the patients of curative effect . The researchers evaluated the efficacy of the patient in 12 week.Evaluation of efficacy in patients if not get the ACR20 response, adjust the treatment plan given the test drug.Test group continue to the test drug,placebo group switch to the test drug.
16000892|NCT02882087|Drug|RC18 160 mg plus MTX|
16000893|NCT02882074|Drug|Human albumin|human albumin 5% during surgery
16000894|NCT02882074|Drug|Hydroxyethyl starch|6% Hydroxyethyl starch 130/0.4 during surgery
16000895|NCT02882061|Procedure|Thoracic spinal manipulation|The most hypomobile (stiff) and/or painful segment between T1-T4 will be determined , and this is the segment to which the examiner will apply the thrust. The manipulation will be performed with subjects lying supine. The examiner will use a 'pistol grip' to apply pressure on the articular pillars of the thoracic segment bilaterally in order to block the inferior vertebrae of the hypomobile segment. The subject will cross their arms over their chest to the point where the elbows are aligned. This will allow the examiner to apply pressure through both elbows in an anterior-to-posterior direction. The examiner will assure the direction of force is felt into his/her stabilizing hand. The subject will be asked to take a deep breath in and then exhale completely. A grade V (HVLA) thrust will be applied at the end of the subject's exhalation. If a cavitation is not heard or felt by either the subject or examiner, a second thrust will be performed.
16000896|NCT02882048|Procedure|NADA Protocol|NADA Protocol is a standardized acupuncture technique in which five designated points in the ear are needled.
16000897|NCT02882048|Other|Medication management|Standard of care medication management defined by an opioid weaning protocol with specific, symptomatic medication regimens.
16000898|NCT02882035|Other|OFA|
16000899|NCT02882022|Device|Continuous positive airway pressure|A CPAP machine will be used to deliver positive pressure at various levels after which middle ear pressure and ear drums will be evaluated for changes.
16000900|NCT02882009|Drug|Gantenerumab|Gantenerumab as a HCLF will be administered via SC injection according to assigned treatment sequence.
16000901|NCT02882009|Drug|Placebo|Gantenerumab Placebo solution will be administered via SC injection according to assigned treatment sequence.
16000902|NCT02881996|Drug|IV tylenol|IV tylenol given scheduled in addition to standard PCA
16000903|NCT02881996|Drug|No IV tylenol|No additional IV Tylenol given
16000904|NCT02881996|Drug|Ketorolac|both groups receive as part of our standard postop pain protocol after all operations
16000905|NCT02881983|Other|the presentation of pictures (static stimuli) or videos (dynamic stimuli)|
16000906|NCT02881970|Drug|autologous cord blood stem cell|
16000907|NCT02881957|Drug|Cholecalciferol|
16000908|NCT02881957|Other|Placebo|Oral syrup placebo
16000909|NCT02881944|Behavioral|Low FODMAP Diet|Diet low in foods containing Fermentable Oligo-, Di-, and Mono-saccharides and Polyols
16000910|NCT02881944|Behavioral|High FODMAP Diet|Typical diet of foods containing Fermentable Oligo-, Di-, and Mono-saccharides and Polyols
16000911|NCT02881931|Behavioral|FuRST 2.0|Cognitive Pre-testing of new Functional Rating Scale
16000912|NCT02881918|Other|Blood sample|Blood sample with 6 tube of blood (40 mL), after diagnosis and before any specific anticancer treatment
16000913|NCT02881905|Device|ball attachment|it is attachment part that connects the overdenture to the implant
16000914|NCT02881905|Device|cm loc attachment|It is a new attachment made of peek material
16000915|NCT02881892|Other|Measure plasma and dialysate level of IL-6, procalcitonin and VEGF|correlation between plasma levels, dialysate appearance rate of VEGF, inflammatory cytokines (IL- 6, procalcitonin) and PSTR, dialysis adequacy in CAPD patients.
16000916|NCT02881879|Biological|Allergovac depot DPT/DF (50:50)|Subcutaneous immunotherapy in depot presentation in a rapid dose escalation scheme: 6 weekly dose increasing injections at the initiation phase plus 3 maintenance monthly injections
16000917|NCT02881866|Drug|Furosemide|
16000918|NCT02881866|Drug|Saline|
16000919|NCT02881853|Drug|XmAb7195|
16000920|NCT02881853|Drug|Placebo|
16000921|NCT02881840|Drug|14C-APD421|
16000959|NCT02881515|Other|High Sodium Diet|Ten days of a high sodium diet
16000960|NCT02881502|Other|severe asthma group|No intervention
16000961|NCT02881489|Other|Biological: Cell-based therapy|Human autologous bone marrow-derived mesenchymal stem cell transplantation in ALS patients.
16000962|NCT02881476|Other|Biological: Cell-based therapy|Human allogeneic Wharton's jelly-derived mesenchymal stem cell transplantation in ALS patients.
16001435|NCT02877784|Procedure|Videofluoroscopic swallowing study|Videofluoroscopic swallowing study will be performed to measure the oropharyngeal swallowing.
16000922|NCT02881827|Radiation|Low level laser therapy|Supported by the physical phenomenon of stimulated emission postulated by Albert Einstein in 1916 the laser (light amplification by Stimulated Emission of Radiation) is a device consisting of solid source materials, liquid or gas that produces beams of light when excited by a source of energy. This bright feature is a particular type of electromagnetic radiation, which differs from that emitted by conventional incandescent sources. These are the effects attributable to LLLT analgesic, anti-inflammatory and biostimulates and has been widely used due to low power densities and wavelengths with a penetration capacity in tissues without the generation of photothermal effects, which makes its feasible use multiple applications in Health area.
16000923|NCT02881827|Other|Placebo|Simulation of treatment with the device switched off
16000924|NCT02881827|Other|Control|"A scientific control group allows the experimental study of a variable at a time, and is a vital part of the scientific method. In a controlled experiment, two identical experiments are conducted. In one, the treatment - tested factor - is applied. In another - control - the tested factor is not applied.
~For example, when testing a drug, it is important to carefully check the suspected drug effects are produced by the drug. Doctors can it with a double-blind study in a clinical trial: two (statistically) identical groups of patients are compared, one gets the drug and the other receives a placebo. Neither subjects nor investigators know which group receives the actual drug, which serves to prevent bias and isolating effects of such drugs."
16000925|NCT02881814|Diagnostic Test|Lung and diaphragm ultrasound|The ultrasound physiotherapist/operator performs a lung and diaphragm ultrasound. He is blinded to the patient's status and clinical physiotherapist examination. He/she is not involved in patient management or patient clinical decision-making. The ultrasound findings are recorded in the LUS report. The LUS report is reported to the clinical physiotherapist and to the intensivist. The ultrasound diagnosis(es) is recorded.
16000926|NCT02881814|Diagnostic Test|Lung and diaphragm ultrasound in MV patients|In case of mechanically ventilated patient at St. Vincent Hospital (Sydney, Australia), LUS scan will be performed immediately following intubation. Additionnal LUS scans will be performed 72h after intubation and Immediately prior to or following extubation.
16000927|NCT02881775|Device|rTMS and exercise|rTMS at 10 Hz (5 sec on, 55 sec off) and light quadriceps isometric exercise (5% MVIC)
16000928|NCT02881775|Device|Sham rTMS and exercise|rTMS unit is on and running but mu metal is placed between the coil and the skull
16000929|NCT02881762|Drug|Maraviroc|Participants will receive 4 weeks of maraviroc (dosing based on concomitant HIV antiretroviral regimen). Serial measurements of HCV viral load will be obtained before, during, and after maraviroc exposure. Study duration will be approximately 12 to 16 weeks.
16000930|NCT02881749|Radiation|Total skin electron beam therapy (TSEBT)|"TSEBT will be given in 6 fractions at 2 Gy per fraction every Monday, Wednesday, and Friday over the course of 2 weeks (total TSEBT dosage is 12 Gy). Supplements up to 8 Gy will routinely be applied to the perineum and soles as well as any other shadowed sites involved by disease, such as the inframammary regions, scalp, etc. Discrete tumors may receive additional boost up to 8 Gy."
16000931|NCT02881749|Drug|mechlorethamine gel 0.016%|The maintenance period for this study includes one year of weekly mechlorethamine gel 0.016%. This period will not begin until the observation period (30 days) has been completed. During the first week of the maintenance period, patients will apply mechlorethamine gel to the entire body surface daily. After the first week, patients will apply mechlorethamine gel to entire body surface one time per week for the rest of the maintenance period.
16000932|NCT02881736|Other|electroencephalographic,magnetic resonance imaging|
16000933|NCT02881723|Procedure|Surgery|
16000934|NCT02881723|Radiation|Radio- chemotherapy|
16000935|NCT02881710|Other|contrast product used to assess biomarkers variations|
16000936|NCT02881697|Other|Adipose tissue sampling|
16000937|NCT02881684|Device|Aspiration Therapy (AspireAssist®)|Use of the AspireAssist device in aspiration therapy
16000938|NCT02881684|Behavioral|Lifestyle Therapy|Lifestyle therapy is a behavioral, diet and physical activity education program
16000939|NCT02881671|Genetic|genetic blood analysis|patients will undergo a blood sample (15 ml) to analyse their genetic profile
16000940|NCT02881658|Dietary Supplement|Plant sterols-enriched soya beverage provided by Vitasoy|the study product is a 2g plant sterols-enriched in 250ml soya beverage
16000941|NCT02881658|Dietary Supplement|Soya beverage provided by Vitasoy|the placebo product is a 250 ml soya beverage
16000942|NCT02881645|Behavioral|Best practices|Nurses in intensive care units will be trained to the best practices protocol for a period of two-month preceding the trial
16000943|NCT02881632|Device|Structured Light Plethysmography (SLP) - Pneumscan|Both healthy infants and bronchiolitis infants will have their chest movements monitored using Structured Light Plethysmography (SLP) performed by a device (Thora-3 Di) using a projector and two cameras. A light pattern of black and white squares is projected on the child's chest and the cameras record how the shape of this pattern changes with breathing. A computer converts this information to show how the child's chest moves during breathing.
16000944|NCT02881619|Drug|Etodolac|The patient will receive a single-dose of Etodolac (400 mg) one hour before the bleaching procedure.
16000945|NCT02881619|Drug|Placebo|The patient will receive a single-dose of placebo one hour before the bleaching procedure.
16000946|NCT02881606|Device|Naso-alveolar molding (NAM)|
16000947|NCT02881606|Device|Computer aided design NAM (CAD/NAM)|
16000948|NCT02881580|Other|No intervention : descriptive study|
16000949|NCT02881567|Drug|Daclizumab|High yield formulation
16000950|NCT02881554|Procedure|Computed Tomography|Undergo SC SPECT/CT
16000951|NCT02881554|Procedure|Single Photon Emission Computed Tomography|Undergo SC SPECT/CT
16000952|NCT02881554|Drug|Technetium Tc-99m Sulfur Colloid|Given IV
16000953|NCT02881541|Procedure|Enhanced support|
16000954|NCT02881541|Procedure|Usual care|
16000955|NCT02881528|Drug|Metformin Hydrochloride|Liquid formula metformin administered by oral syringe in a dose of 10mg/kg body weight once daily for 2 weeks, then to 10mg/Kg twice daily (maximum 500mg twice daily) for a further two weeks during the first month, increasing to 20mg/kg body weight twice daily (maximum 1000mg twice daily) thereafter.
16001019|NCT02881086|Drug|Cytarabine|
16001020|NCT02881086|Drug|Vindesine|
16001021|NCT02881086|Drug|Adriamycin|
16001022|NCT02881086|Drug|Prednisolone|
16001689|NCT02875886|Other|Low-sodium diet|
16000963|NCT02881463|Other|therapeutical exercises|Participants of experimental group performs daily an 8-week home therapeutical exercise program. Exercises are periodized by weeks (1-8 weeks). The aim of program is the leg muscle strengthening using an elastic band (Thera-Band, System of Progressive Exercise, USA), body balance training, and leg muscle stretching.
16000964|NCT02881437|Drug|IgHy10|Sub Cutaneous IgHy10 administration
16000965|NCT02881411|Other|Self-soft tissue therapy|Manual therapy for the muscles in the upper or lower limbs.
16000966|NCT02881411|Other|Fibromyalgia coping skills programme|Exercise, education programme
16000967|NCT02881398|Device|mHealth|After randomization and at the time of the initial encounter, study subjects are assessed at the point-of-care with mHealth devices that measure symptoms, functional status, and for structural abnormalities. These devices include activity monitoring for an assessment of a 6-minute walk test, smartphone connected blood pressure, oxymetry and ECG for functional assessments, and structural assessments with handheld-echocardiography and point-of-care BNP. Treatment decisions for an intervention with percutaneous valvuloplasty or valve replacement were performed based on the aggregate of these mHealth findings. Confirmation of the severity of structural heart disease on transthoracic echocardiography was performed on all participants.
16000968|NCT02881398|Other|Standard-Care|After randomization and at the time of the initial encounter, study subjects randomized to standard-care underwent a physical examination, 12-lead ECG, radiographic and laboratory tests as warranted and clinically required. Treatment decisions for percutaneous valvuloplasty or valve replacement were based on the aggregate of the standard-care findings. Confirmation of the severity of structural heart disease on transthoracic echocardiography was performed on all participants.
16000969|NCT02881372|Other|Oral food desensitization|The child's specific food antigen will be diluted in a 50% glycerin/water solution containing ascorbic acid (Vitamin C). This oral spray solution will need to be administered twice a day, every day for a total of 4 months
16000970|NCT02881359|Device|LifeSeal® Kit|used as an adjunct to suture or staple line during standard surgical repair of the GI tract (anastomosis or linear) to provide re-inforcement and help reduce leaks.
16000971|NCT02881346|Drug|Enstilar®|Once daily application of cutaneous foam to plaques on body and/or extremities
16000972|NCT02881333|Genetic|Blood samples|
16000979|NCT02881307|Dietary Supplement|Whey Protein&Prebiotic Supplement|Dietary supplement (protein drink) commercially available protein shakes
16000980|NCT02881307|Behavioral|Dietary Counseling|Dietary Counseling
16000981|NCT02881307|Behavioral|Dietary recommendations|recommendations for one meal per day including lean protein and vegetables
16000982|NCT02881294|Drug|SUVN-G3031|
16000983|NCT02881281|Other|educational program for Development of problem-solving skills|
16000984|NCT02881281|Other|no education program|no education program
16000985|NCT02881268|Other|blood sample|
16000986|NCT02881255|Device|Implantable Cardioverter Defibrillator|Patients will be randomized to receive either a subcutaneous or transvenous ICD.
16000987|NCT02881242|Other|Laboratory Biomarker Analysis|Correlative studies
16000988|NCT02881242|Other|Quality-of-Life Assessment|Ancillary studies
16000989|NCT02881242|Drug|Trametinib|Given PO
16000990|NCT02881216|Device|Synergy Stent|Patients with narrowed coronary artery disease qualifying for PCI were treated with Synergy stent implantation.
16000991|NCT02881216|Device|Currently common drug-eluting stent (DES)|Patients with narrowed coronary artery disease qualifying for PCI were treated with DES implantation (Xience Prime, Resolute Integrity, Promus Element Plus)
16000992|NCT02881203|Device|Breathe Well|Breathe Well is an audiovisual biofeedback device used to assist patients to regulate their breathing whilst undergoing radiation treatment.
16000993|NCT02881203|Device|RPM|Varian Real-time Position Management (RPM) system
16000994|NCT02881190|Drug|RC48-ADC|
16000995|NCT02881177|Drug|Oxytocin|40 IU
16000996|NCT02881177|Drug|Placebo|40 IU
16000997|NCT02881164|Other|Low glycemic index|Subjects intake a low glycemic index breakfast
16000998|NCT02881164|Other|High glycemic index|Subjects intake a high glycemic index breakfast
16000999|NCT02881151|Device|Deep brain stimulation|Delivery of continuous, low-voltage electrical pulses to deep portions of the brain via an implantable pacemaker-like device.
16001000|NCT02881138|Drug|RC48-ADC|
16001001|NCT02881125|Drug|Nortriptyline Hydrochloride|Given PO
16001002|NCT02881125|Drug|Paclitaxel|Given IV
16001003|NCT02881112|Device|Provant Therapy System|Treatment with the Provant Therapy System
16001004|NCT02881086|Drug|Rituximab|
16001005|NCT02881086|Drug|Nelarabine|
16001006|NCT02881086|Drug|PEG-Asparaginase|
16001007|NCT02881086|Procedure|Cranial irradiation|
16001008|NCT02881086|Drug|Imatinib|
16001009|NCT02881086|Drug|Idarubicin|
16001010|NCT02881086|Drug|Dexamethasone|
16001011|NCT02881086|Drug|Cyclophosphamide|
16001012|NCT02881086|Drug|Fludarabine|
16001013|NCT02881086|Drug|Vincristine|
16001014|NCT02881086|Drug|Mercaptopurine|
16001015|NCT02881086|Drug|VP16|
16001016|NCT02881086|Drug|Daunorubicin (DNR)|
16001017|NCT02881086|Drug|Methotrexate|
16001018|NCT02881086|Procedure|Stem cell transplantation|
16001023|NCT02881073|Other|Maternal plasma PlGF quantification|A point of care test performed on maternal plasma, to quantify the level of the protein PlGF (placental growth factor) in the serum of the pregnant woman with suspected pre eclampsia to help the clinician in stratifying the level of further care for her in her pregnancy
16001024|NCT02881060|Dietary Supplement|Alcohol|
16001025|NCT02881060|Dietary Supplement|Placebo|
16001026|NCT02881047|Device|CO2 Laser|Perform ablative fractional resurfacing using a 10,600nm carbon dioxide (CO2) laser targeted to thickened, sclerotic plaques causing range of motion limitation and contracture across joints.
16001027|NCT02881047|Radiation|Ultrasound|Patients will undergo ultrasound of the planned treatment site to measure skin thickness and blood flow via Doppler ultrasound.
16001028|NCT02881047|Diagnostic Test|Skin Biopsy|standard 4mm punch biopsy of the skin at the planned treatment site for histologic assessment of skin thickness and sclerosis.
16001029|NCT02881034|Drug|Triple therapy|
16001030|NCT02881021|Other|Rehabilitation program|Standardized conventional evidence-based physiotherapy for treating rotator cuff tendinopathy.
16001031|NCT02881021|Device|Kinesiotaping|Combined Kinesiotaping techniques (3 strips) for rotator cuff tendinopathy, following the principles of Kenzo Kase et al. (2003).
16001032|NCT02881008|Drug|Entecavir|
16001033|NCT02881008|Drug|Myrcludex B|
16001034|NCT02880995|Device|PET scan|The patient group and the healthy control group will undergo PET scan at the baseline. the investigators are going to measure striatal dopamine synthesis capacity using [18 fluorine(F)]DOPA positron emission tomography in drug-naïve first episode psychosis and determine treatment response after 6 weeks of treatment with amisulpride. Response will be defined as a >30% reduction in symptom ratings on the Positive and Negative Syndrome Scale.
16001035|NCT02880995|Behavioral|clinical scale|Patient group should complete clinical scales at baseline and 6 week.
16001036|NCT02880995|Drug|6 weeks of treatment with amisulpride|The investigators are going to measure striatal dopamine synthesis capacity using [18 fluorine(F)]DOPA positron emission tomography in drug-naïve first episode psychosis and determine treatment response after 6 weeks of treatment with amisulpride. Response will be defined as a >30% reduction in symptom ratings on the Positive and Negative Syndrome Scale.
16001037|NCT02880982|Dietary Supplement|Cholecalciferol|Weekly oral softgel capsule containing 10,000 IU (250 micrograms) cholecalciferol (vitamin D3)
16001038|NCT02880982|Other|Placebo|Weekly oral placebo softgel capsule
16001039|NCT02880969|Behavioral|answering questionnaires|
16001040|NCT02880956|Drug|ABBV-8E12|ABBV-8E12 solution for IV infusion
16001041|NCT02880956|Drug|placebo for ABBV-8E12|placebo solution for IV infusion
16001042|NCT02880943|Drug|XOFIGO|"XOFIGO® will be administered intravenously as a bolus injection every 4 weeks with a maximum of 6 administrations per patient.
~Four dose levels are available for evaluation : 27.5 kBq/kg, 55 kBq/kg, 88 kBq/kg and 110 kBq/kg.
~Starting dose for phase I will be 55 kBq/kg."
16001043|NCT02880930|Dietary Supplement|Fultium-D3 drops (Internis)|Oral daily doses of vitamin D3 (400 IU for 3 months; and 1,000 IU for an additional 3 months)
16001044|NCT02880917|Device|tDCS-Sham|Sham tDCS will involve an identical electrode montage, with stimulation ceasing after a 30-second ramp-up period to provide equivalent scalp sensation.
16001045|NCT02880917|Device|tDCS-Active|tDCS was delivered using the anode electrode positioned over the left dorsolateral prefrontal cortex (DLPFE) and the cathode electrode at supra orbital right region. The electrodes were placed into a 25-35 cm2 square sponge immersed in saline solution for better current conductivity. Current density used was 2 mA and electrodes attached to the scalp were sustained by rubber band.
16001046|NCT02880917|Other|Cognitive training|. The cognitive training consisted of an online application of a Dual N-Back task .The Training will last for 8 days.
16001047|NCT02880904|Other|Photography|Photos will be taken of the vulvar lichen sclerosus lesions.
16001048|NCT02880891|Procedure|prothetic procedure|splinted crown
16001049|NCT02880878|Procedure|Early Surgical Hematoma Evacuation|Early Minimally Invasive Parafascicular Surgery (MIPS)
16001050|NCT02880865|Biological|Live attenuated SA 14-14-2 Japanese Encephalitis vaccine|Single 0.5 mL dose of World Health Organization prequalified live, attenuated SA 14-14-2 JE vaccine manufactured by Chengdu Institute of Biological Products, Chengdu, China, administered by subcutaneous injection
16001051|NCT02880865|Biological|Measles, mumps, rubella vaccine|Single 0.5 mL dose of live, attenuated measles-mumps-rubella vaccine (Schwarz measles virus, RIT 4385 mumps strain, and Wistar RA 27/3 rubella virus) manufactured by GlaxoSmithKline, Inc., administered by subcutaneous injection.
16001052|NCT02880852|Drug|Belimumab|Belimumab will be provided as white uniform lyophilized cake in vials with unit dose strength of 400 mg/vial plus excipients (citric acid/sodium citrate/sucrose/polysorbate) for reconstitution in 4.8 milliliter sterile water for injection (SWFI). Belimumab will be administered as 10 mg/kg intravenous infusion for over 1 hour on Day 0.
16001053|NCT02880839|Device|Partial cervical lamina excision group|Patients with cervical fracture were assigned to undergo partial cervical lamina excision and cervical pedicle screw internal fixation.
16001054|NCT02880839|Device|Pipeline-dredge discharge group|Patients with cervical fracture were assigned to undergo pipeline-dredge discharge and cervical pedicle screw internal fixation.
16001055|NCT02880839|Device|Digital navigation group|Patients with cervical fracture were assigned to undergo digital navigation assisted cervical pedicle screw placement.
16001056|NCT02880826|Behavioral|Measure the culture of safety in the reanimation units|
16001057|NCT02880813|Other|Infusion|infusion of nutrients
16001058|NCT02880800|Drug|Morphine as IVPCA|"Morphine as IVPCA: Patients will be given a patient controlled analgesia (PCA) pump containing a standard solution of morphine as below:
~Morphine bolus 1mg with a lockout interval of 5 minutes, no background infusion and maximum 30 mg in 4 hours"
16001059|NCT02880800|Drug|Hydromorphone as IVPCA|"Hydromorphone as IVPCA: Patients will be given a patient controlled analgesia (PCA) pump containing a standard solution of Hydromorphone as below:
~Hydromorphone bolus 0.2 mg with a lockout interval of 5 minutes and a maximum dose of 6 mg in 4 hours."
16001060|NCT02880800|Drug|Morphine|IV opioids: Morphine 2 to 5 mg every 1h PRN (max. 20 mg/4h)
16001061|NCT02880800|Drug|Hydromorphone|Hydromorphone 0.5 - 1 mg every 1h PRN (max. 4 mg/4h)
16001211|NCT02879656|Procedure|operative treatment|surgery with volar locking plate with modified Henry's volar approach
16001062|NCT02880787|Drug|Rocuronium|Anesthesia induction with Propofol and maintaining with desflurane. For adult patients, the curare is rocuronium (0.6 mg/kg) For pediatric patients, the curare can be rocuronium (0.6 mg/kg), cisatracurium (0.1 mg/kg) or atracurium (0.5 mg/kg)
16001063|NCT02880787|Device|Neuromuscular monitoring with TOFScan® and TOF-Watch SX®|Each monitor on one arm
16001064|NCT02880774|Other|mandibular nonspecific mobilization|The mobilization will be held with the individual in supine position, by a trained and experienced therapist, where using disposable gloves, will position the first finger on the last molar, performing intermittently mobilization during 1 minute, will be held five repetitions. Going on a break during the repetition, in that the individual will carry out 15 times language exercises on the palate. With regard to mobilizing joint side, this will be previously set by means of the RDC/TMD and may be unilateral or bilateral basis, depending on the diagnosis. The therapist will remain in orthostatic in opposite side the mobilization to prevent any pressure on the jaw. The treatment will last for 4 weeks, 3 times a week, for a total of 12 sessions.
16001065|NCT02880774|Other|Ultrasound detuned,|Will be held the identical positioning to group A with the individual supine on the stretcher, used ultrasound equipment detuned on the region of the face with the presence of TMD. The procedures of this group will have a duration of 4 weeks, 3 times a week, for a total of 12 sessions.
16001066|NCT02880761|Procedure|Assessment guiding surgery and puncture for AVF|Assessment guiding surgery and puncture for AVF. Assessing the parameters of vascular vessels during following-up and making suggestions on surgery and puncture of AVF
16001067|NCT02880748|Other|Water exchange (WE) method|Water exchange (WE) method was used for insertion to the cecum. And air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal procedure.
16001068|NCT02880748|Other|Air insufflation (AI) method.|Air insufflation (AI) method was used for insertion to the cecum. And air was insufflated to distend the lumen for inspection and biopsy or polypectomy during withdrawal procedure.
16001069|NCT02880735|Device|Non Invasive Ventilation.|Non Invasive Mechanical Ventilation through oronasal mask. Mode: Bilevel with rate backup (spontaneous/time). Inspiratory Pressure: 30-10, Expiratory Pressure : 4-15, Backup Rate;14-25 rpm. Use Time: During Sleep.
16001070|NCT02880709|Dietary Supplement|Special diet|Tate and energy content adjusted with spices to obtain maximal intake
16001071|NCT02880696|Behavioral|Regular stimulation sequence|Vibrotactile stimulation of the right hand with regular intervals and random omissions
16001072|NCT02880696|Behavioral|Random stimulation sequence|Vibrotactile stimulation of the right hand with random intervals and random omissions
16001073|NCT02880696|Device|DCS|Near-infrared imaging of the neurovascular response in the left somatosensory cortex
16001074|NCT02880683|Device|NeuroTronik CANS Therapy System|
16001075|NCT02880670|Drug|BMS-986142|
16001076|NCT02880657|Dietary Supplement|SODB®|Subjects are supplemented with SODB®, daily over 10 weeks. Each volunteer was seen for the 4 visits: - visit of pre-inclusion V1, - visit V2, so-called inclusion visit, - visit V3 after 4 weeks of physical training and - visit V3 after 8 weeks of physical training
16001077|NCT02880657|Dietary Supplement|Placebo|Subjects are supplemented with Placebo, daily over 10 weeks. Each volunteer was seen for the 4 visits: - visit of pre-inclusion V1, - visit V2, so-called inclusion visit, - visit V3 after 4 weeks of physical training and - visit V3 after 8 weeks of physical training
16001078|NCT02880631|Device|BAROSTIM NEO™ System|
16001079|NCT02880618|Device|Barostim Neo™ System|
16001080|NCT02880592|Other|Affinity Allograft|fresh hypothermically stored human amniotic membrane
16001081|NCT02880592|Other|Standard of care|offloading, debridement, infection management using appropriate dressings
16001082|NCT02880566|Procedure|Scalp block|Full scalp block
16001083|NCT02880540|Drug|Fentanyl|
16001084|NCT02880540|Drug|Morphine|
16001085|NCT02880540|Drug|Dexmedetomidine|
16001086|NCT02880527|Other|Patients with polymyositis / dermatomyositis|"recruitment of patients with polymyositis / dermatomyositis using :
~medical specialists , hospital and liberals who support patients with polymyositis / dermatomyositis ( internists , dermatologists, neurologists, pulmonologists , rheumatologists ) ;
~general practitioners
~the PMSI data for public and private hospitals ; 4 ) data boxes regional health insurance (primary health insurance fund , MSA Normandy , Social Scheme for Self )
~5) Norman patients, members of an association of patients with polymyositis / dermatomyositis : the French Muscular Dystrophy Association"
16001087|NCT02880514|Device|PROPEL Mini Sinus Implant|Sinus implant with 370 mcg of mometasone furoate released over 30 days
16001088|NCT02880514|Procedure|Balloon Sinus Dilation Alone|
16001089|NCT02880501|Device|proximal femoral nail antirotation|Twenty patients with intertrochanteric femoral fracture scheduled to undergo proximal femoral nail antirotation (PFNA) implantation.
16001090|NCT02880475|Drug|OXN PR tablet|Orally administered OXN PR tablet 5/2.5 mg or OXN PR tablet 20/10 mg
16001091|NCT02880462|Dietary Supplement|sulforaphane|Sulforaphane is a compound that can be extracted from broccoli, Brussel sprouts, cabbage, and other cruciferous plants.
16001092|NCT02880462|Other|placebo|Placebo is made of starch
16001093|NCT02880449|Behavioral|Intervention|A PA promoting intervention which provides education, social support and information about local opportunities for PA to pre-existing groups of older women living in socio-economically disadvantaged areas
16001094|NCT02880436|Other|air pollution|impact of various pollution agents above threshold and their correlation with acute myocardial infarctions are analyzed
16001095|NCT02880423|Procedure|tubal ligation group II|"Every woman , who is eligible to enter the study in terms of the above criteria , will receive a detailed explanation of the study and will review the consent form , and then be asked whether she agrees to participate in . If so , the participant will stamped on the informed consent form .
~The control group will be women who undergo tubal ligation method BTL during cesarean section . All women will be invited to follow up about three months after surgery. The women will answer questionnaire to quantify the symptoms of menopause by NAMS , blood test for AMH and sonar and Doppler examination of both the ovaries"
16001096|NCT02880423|Procedure|salpingectomy group I|women who agreed to participate in the study and assigned randomly to this group will have salpingectomy during cesarean section for sterilization.
16001097|NCT02880410|Device|NeuroBlate System|Laser Interstitial Thermal Therapy
16001098|NCT02880410|Drug|Radiation therapy and temozolomide|Radiation therapy and temozolomide
16001099|NCT02880397|Drug|Garcinia mangostana|The properties of mangostana includes antibacterial, antifungal, anti-inflammatory, anti-microbial, antioxidant, anticancer, anti-proliferative, pro-apoptotic, aromatase inhibitory properties
16001100|NCT02880397|Drug|Placebo gel|The properties of placebo includes antibacterial, antifungal, anti-inflammatory, anti-microbial, antioxidant, anticancer, anti-proliferative, pro-apoptotic, aromatase inhibitory properties
16001101|NCT02880384|Other|FilmArray LRTI v.2.0 IUO Panel|Patients will provide sputum or sputum equivalent to be probed with FilmArray LRTI v.2.0 IUO Panelpanel.
16001102|NCT02880371|Drug|ARRY-382|ARRAY-382 will be taken by mouth once daily at a fixed dose.
16001103|NCT02880371|Drug|Pembrolizumab|Pembrolizumab will be administered intravenously over 30 minutes every 3 weeks.
16001104|NCT02880345|Drug|PEMBROLIZUMAB|
16001105|NCT02880345|Radiation|hypofractionated radiation|
16001106|NCT02880332|Other|Usual care|During usual care therapy, children and their parents will receive a +/- 1 h session containing bio-medical directed education and information about the gastro-intestinal system and its function. This knowledge will be brought to bear with a hypnotic journey through their body, guided by a nurse with specific expertise in pediatric abdominal pain. Furthermore, the influence of stress on the gastro-intestinal system will be explained, combined with exercises to practise abdominal respiration.
16001107|NCT02880332|Other|Pain Neuroscience education|"This therapy will consist out of a +/- 1 h one-on-one educational session about neurophysiology of pain, adjusted to the child's comprehension status. The content of the education sessions and pictures will be based on the book Explain Pain by Butler and Moseley and will include explanation and reassurance about the cause of pain, a brief summary of relevant pain mechanisms and the integral role of psychosocial and physical factors in precipitating and maintaining pain. Metaphors, leaflets, books and audio-visual media will be used in a supportive function to consolidate verbally transmitted information. Parents will participate in the PNE session as well."
16001108|NCT02880332|Other|Extra care|During this therapy session, all the patient's/ parents questions that arose from the previous session (Usual care) will be answered. Afterwards, the educated content from this previous session will be revised. Nothing new will be taught. At the end of the session, the participant will be asked to demonstrate the previously learned exercises on abdominal respiration. If the exercises are not well performed, the therapist will correct them.
16001109|NCT02880319|Drug|Stereotactic Body Radiation Therapy (SBRT)|
16001110|NCT02880319|Device|Stereotactic Linear Accelerator|
16001111|NCT02880306|Other|RA|RA was diagnosed based on the 1987 American College of Rheumatology diagnostic criteria
16001112|NCT02880293|Drug|melphalan|melphalan (140 mg/m2 IV on day -7)
16001113|NCT02880293|Drug|fludarabine|fludarabine (40 mg/m2/d on days -5 through -2)
16001114|NCT02880293|Drug|thiotepa|thiotepa (5 mg/kg IV on day -67)
16001115|NCT02880293|Drug|Cyclophosphamide|cyclophosphamide (50 mg/kg IV on day +3 and +4)
16001116|NCT02880293|Drug|Mesna|
16001117|NCT02880293|Drug|Mycophenolate Mofetil|(15 mg/kg PO/IV TID)
16001118|NCT02880293|Drug|Filgrastim|
16001119|NCT02880293|Drug|Tacrolimus|
16001120|NCT02880280|Drug|Human Menopausal Gonadotropin|Human Menopausal Gonadotropin injection treating congenital hypogonadotropic hypogonadism in teenagers
16001121|NCT02880280|Drug|Human Chorionic Gonadotropin|Human Chorionic Gonadotropin injection treating congenital hypogonadotropic hypogonadism in teenagers
16001122|NCT02880267|Device|CGM|Glucose challenge during a clinic session to assess CGM performance compared to a laboratory reference measurement.
16001123|NCT02880254|Device|Kurbo|health/weight loss app designed for children and adolescents to help them track intake, output and understand healthy eating habits
16001124|NCT02880254|Device|Personal Health Coach|weekly health coach via facetime or Skype to motivate and counsel subjects during the weight loss process
16001125|NCT02880241|Drug|MMV390048|Tablets of 20mg each
16001126|NCT02880228|Drug|Dexamethasone|Given PO
16001127|NCT02880228|Other|Laboratory Biomarker Analysis|Correlative studies
16001128|NCT02880228|Drug|Lenalidomide|Given PO
16001129|NCT02880228|Biological|Pembrolizumab|Given IV
16001130|NCT02880215|Behavioral|Attention Bias Modification|Behavioral intervention designed to decrease negative attention bias.
16001131|NCT02880215|Behavioral|Cognitive Control Training|Behavioral intervention designed to improve sustained attention.
16001132|NCT02880202|Other|Massage Therapy|The massage therapy is provided by certified massage therapists and delivered in the home setting. Techniques and duration of massage therapy is customized based on input from the patient and/or caregiver at the start of the session regarding nature and location of discomfort and other symptoms, and based on other factors such as contra-indications/complicating factors, medical issues, and additional diagnoses. The number of massage therapy interventions range from 2-3, 1 week apart, with each session lasting between 20-45 minutes in duration.
16001133|NCT02880189|Device|Orbera Intragastric Balloon|The Orbera Intragastric Balloon will be placed in the stomach endoscopically through a catheter under conscious sedation. The procedure takes about 20 minutes to complete. The balloon will stay in place for 6 months and then it will be removed endoscopically.
16001134|NCT02880189|Procedure|Endoscopic Ultrasound Guided Core Liver Biopsy|
16001135|NCT02880176|Other|Financial Incentive to Increase Ambulation|Financial Incentive and possibility for financial lottery entry in addition to education on the benefits of post-surgery ambulation
16001136|NCT02880163|Device|ResQFoam|Hemostatic device for the treatment of emergent, exsanguinating, Class III or IV intraabdominal hemorrhagic shock in subjects due to trauma
16001137|NCT02880150|Other|Stress test|
16001138|NCT02880137|Drug|Perflutren Lipid Microsphere|Definity (injectible suspension ultrasound contrast agent) will be diluted with saline for both Pediatric and Adult subjects. For pediatric subjects under 60kg (kilogram), the dose will be 20 MicroL/kg (MicroLiter/kilogram) diluted to the same concentration used in the adult dosing. Hand Injections will be performed at baseline, Pre-peak, and peak perfusion stages.
16001139|NCT02880137|Procedure|RTMPE|Utilizes intravenous administration of biologically-inert microbubbles to assess myocardial perfusion and has demonstrated utility for identifying small vessel coronary artery disease.
16001251|NCT02879331|Procedure|15 coils in upper and lower lobes|
16001252|NCT02879331|Procedure|cycloergometry|
16001253|NCT02879318|Drug|Gemcitabine|
16001140|NCT02880124|Dietary Supplement|Solution ingestion|Subjects will be required to ingest 2 litres of the experimental solution, spread over the 2 hours of exercise. A first ingestion of 572 mL of solution will be made at rest, 30 minutes before starting exercise, and 286 mL will be ingested immediately before the start of exercise and every 30 minutes during the exercise period.
16001141|NCT02880124|Behavioral|Constant load cycling|Subjects will be required to perform 2 hours of cycling exercise at a power output eliciting 60% of VO2max.
16001142|NCT02880124|Procedure|Expired gas sampling|Subjects will be asked, twice, to provide a forced expiration into a 10 mL plastic tube in order to collect a sample expired gases. This procedure will be done immediately before blood sampling and ingestion of the solution, every 30 minutes.
16001143|NCT02880124|Procedure|Indirect respiratory calorimetry|A mouthpiece and nose plug will be placed on the subject and expired gases will be analyzed by a metabolic cart during 3 minutes. This procedure will be done immediately before expired gas collection, blood sampling and ingestion of the solution, every 30 minutes.
16001144|NCT02880124|Other|Palatability|Subjects will be asked to fill out a short form on the palatability of the solution ingestion, after ingesting the first solution and at the end of exercise, after ingestion the last solution.
16001145|NCT02880124|Other|Gastrointestinal|At the end of the time trial, subjects will be asked to fill out a short form on gastrointestinal issues they might have had during experimentation.
16001146|NCT02880124|Procedure|Blood sampling|A catheter will be inserted in an antecubital vein and a saline solution will be continuously perfused to maintain the vessel open. 15 mL of blood will be collected every 30 minutes, immediately before ingesting the solution.
16001147|NCT02880124|Behavioral|Time trial|Subjects will be required to complete a simulated 20-km time trial on the cycle ergometer set in linear mode (where resistance is proportional to pedalling cadence), starting at 70% of the peak power output for the cadence spontaneously adopted by the subject during 2 hours of exercise.
16001148|NCT02880098|Biological|Troponin T blood level|assess Troponin T blood level for every child born from the same sample of blood (after clamping the umbilical cord) used for assessment of pH and lactate.
16001149|NCT02880085|Drug|Local anesthetic|local injection
16001150|NCT02880072|Dietary Supplement|phosphate orally|4 different preparations of phosphate
16001151|NCT02880059|Device|Cardiorepiratory Polygraphy|Sleep apnea screening by out-of-center polysomnography/polygraphy
16001152|NCT02880033|Drug|deferiprone|to test the action of deferiprone on lymphocytes from patients and controls ex vivo
16001153|NCT02880033|Drug|placebo|to control the action of placebo on lymphocytes from patients and controls ex vivo
16001154|NCT02880020|Biological|Ipilimumab|Given IV
16001155|NCT02880020|Other|Laboratory Biomarker Analysis|Correlative studies
16001156|NCT02880020|Biological|Nivolumab|Given IV
16001157|NCT02880007|Radiation|External Beam Radiation Therapy|45 Gy pelvis / 25 fr
16001158|NCT02880007|Radiation|PDR Brachytherapy|1 puls/hour ; 12 Gy / day
16001159|NCT02880007|Drug|Cisplatin|increase in dose to the target volume at high risk (85 to 90 Gy over 90% of its volume) and the intermediate target volume (60 Gy to 90 % of its volume) in 3D Pulsed Dose Rate Brachytherapy
16001160|NCT02879994|Other|Laboratory Biomarker Analysis|Correlative studies
16001161|NCT02879994|Biological|Pembrolizumab|Given IV
16001162|NCT02879981|Drug|Guaifenesin|Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.
16001163|NCT02879981|Drug|Sulfamethoxazole|Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.
16001164|NCT02879981|Drug|Trimethoprim|Administration of treatment will be according to treating physician's recommendation under local labeling. The study protocol does not specify any treatment regimen.
16001165|NCT02879968|Other|Non-interventional study|
16001166|NCT02879955|Other|Glucose + Fructose|Ingestion of the separate monosaccharides glucose (25 g) and fructose (25 g) dissolved in 200 mL of water. The load provides 0.1385 mol glucose and 0.1385 mol fructose.
16001167|NCT02879955|Other|Sucrose|Ingestion of the disaccharide sucrose (47.5 g) dissolved in 200 mL of water. The load provides 0.1385 mol glucose and 0.1385 mol fructose.
16001168|NCT02879955|Other|Isomaltulose|Ingestion of the slowly digestable disaccharide isomaltulose (47.5 g) dissolved in 200 mL of water. The load provides 0.1385 mol glucose and 0.1385 mol fructose.
16001169|NCT02879955|Other|Sucrose + Acarbose|Ingestion of the disaccharide sucrose (47.5 g) and the alpha glucosidase inhibitor acarbose dissolved in 200 mL of water. The load provides 0.1385 mol glucose and 0.1385 mol fructose.
16001170|NCT02879942|Other|Ultrasound study of the placenta|The placenta will be scanned to measure the placental volume, chorionic plate, basal plate and thickness.
16001171|NCT02879942|Other|Measurement of angiogenic and anti-angiogenic factors (sFlt-1 and PlGF) in the first trimestre blood test|
16001172|NCT02879916|Drug|Levobupivacaine|Inject 3ml of levobupavacaine into the stellate ganglion area
16001173|NCT02879916|Drug|NaCl 0.9%|Inject 3ml of NaCl 0.9% into the stellate ganglion area
16001174|NCT02879903|Procedure|Periodontal treatment|"An experienced periodontist will be performed clinical periodontal parameters, including Plaque Index, Bleeding On Probe, Pocket Probing Depth, Gingival Recession, Clinical Attachment Level using a periodontal probe, at six sites per tooth at all teeth, excluding third molars.
~Quadrant scaling and root planning will be weekly performed on each patient under local anesthesia using periodontal curettes and ultrasonic scalers. The maintenance therapy will be included professional plaque control and Scaling and root planing in recurrent periodontal pockets."
16001175|NCT02879903|Procedure|Microbiological collect|Biofilm will be collected with the paper point to analyse presence of Porphyromonas gingivalis fimbrial subunit gene type I, II, III, IV and V.
16001176|NCT02879903|Procedure|Questionnaire|Age will be expressed in years Sex -female and male, will be expressed in percentage. Time of cigarette consumption - will be expressed in years
16001177|NCT02879877|Drug|UCB7858|
16001178|NCT02879877|Drug|Placebo|
16001254|NCT02879318|Drug|Nab-paclitaxel|
16001255|NCT02879318|Drug|Durvalumab|
16001256|NCT02879318|Drug|Tremelimumab|
16001257|NCT02879305|Drug|Daprodustat|Daprodustat dose is based on prior ESA dose, the dose is adjusted thereafter in order to achieve the target range.
16001179|NCT02879864|Device|light therapy|The light therapy, 6 month's program, is occurring at patient's home the day after device's reception and during at least 7 days before chemotherapy's beginning. The ambulatory light program is daily exposure to a high-intensity light (10,000 lux) in the morning, at a time adapted to the patient according to his chronotype for 30 minutes. The light source should be placed at eye level (distance of about 40 cm). A set of questionnaires evaluation of fatigue and quality of life will be given to the patient at baseline and at weeks 12 and 24, which will be completed the same day or the day before, and / or before any chemotherapy. These questionnaires will be also completed during the follow-up visit 1 month after the last visit (week 28).
16001180|NCT02879864|Device|Usual care|The patient will be taken care of according to local chemotherapy in routine care and the recommendations. A set of questionnaires evaluation of fatigue and quality of life will be given to the patient at baseline and at weeks 12 and 24. They will complete the same day or the day before, and / or chemotherapy before. A follow-up visit will be performed 1 month after the last visit (week 28). A set of questionnaires evaluation of fatigue and quality of life will be given to the patient and will complete the same day or the day before.
16001181|NCT02879838|Other|Blood sample|Biobank. Analysis of cytokines and DNA polymorphisms
16001182|NCT02879825|Device|Cardiac MRI|"Group-A patients, with mitral valve prolapse but no mitral regurgitation, will undergo specifically for research purposes a cardiac MRI, 24-hour external loop recording and exercise ECG on top of regular echocardiography evaluation.
~Realization of these examinations will be performed according to recommendations for patients with mitral regurgitation (groups B, C and D)"
16001183|NCT02879812|Other|Performance Feedback Reports|Medical directors will be provided performance feedback reports that are a summary of clinical performance of transplant and racial disparity performance over a period of time aimed at providing information to allow them to assess and adjust their transplant performance. The report will emphasize tailored facility-specific information on the mean time on dialysis for patients in that facility and transplant access performance measures, such as wait listing and transplantation, including the magnitude of racial disparity, detailing when a facility is performing below the national or regional average.
16001184|NCT02879812|Other|Educational Video for Staff|Dialysis facility staff will watch a ~10 minute educational video that describes the role of dialysis staff in improving transplant access, the new kidney allocation policy, and how the new policy impacts minority patients and those on dialysis for a substantial period of time.
16001185|NCT02879812|Other|Educational Video for Patients|Dialysis facilities will receive a ~10 minute educational video targeted to dialysis patients to explain the transplant process and allocation policy.
16001186|NCT02879812|Other|Educational Webinar|Education for medical directors and facility staff about the kidney allocation policy will be discussed in a webinar and information will be hosted on a website for participants to access. The seminar will be roughly 45 minutes, and CME will be offered.
16001187|NCT02879812|Other|Standard Care|Dialysis facilities will conduct standard or usual care and education regarding transplantation.
16001188|NCT02879812|Other|United Network for Organ Sharing (UNOS) Pamphlet|Dialysis facility staff will be provided an educational pamphlet detailing the changes in the new kidney allocation policy .
16001189|NCT02879799|Other|Implement Family Integrated Care|Specially trained FICare nurses will provide education and support for families to provide care for the baby while they are present in the NICU. Study mothers will meet with veteran parents for additional support. Families will keep a log of their activities and costs.
16001190|NCT02879786|Other|Posturographic tests|
16001191|NCT02879786|Other|Questionnaire of motion sickness susceptibility|
16001192|NCT02879773|Radiation|CTPVe|Non contrast computed tomography (CTPVe) scan during end inspiration and end expiration in supine position
16001193|NCT02879760|Biological|Ad-MAGEA3|Intramuscular injection
16001194|NCT02879760|Biological|MG1-MAGEA3|Intravenous infusion
16001195|NCT02879760|Biological|Pembrolizumab|Intravenous infusion
16001196|NCT02879747|Drug|Genotropin|Children were randomized to either decreased dose by 50% or unchanged dose after 2-3 years of Catch-up growth
16001197|NCT02879734|Other|Prophylactic laparoscopic omentopexy|Fixation of omentum with sutures to anterior abdominal wall during laparoscopic surgery
16001198|NCT02879721|Drug|Candesartan|Angiotensin II, type 1 receptor inhibitor, (candesartan) 8 mg once daily for
16001199|NCT02879721|Drug|Enalapril|Angiotensin-converting enzyme (ACE) inhibitor (enalapril) 5 mg once daily
16001200|NCT02879708|Other|Information Only|Households will receive information regarding their rights and entitlements pertaining to healthcare, certain health outcomes specific to their village, as well as health-related activities happening in their village (such as the VHSNC meetings and Village Health and Nutrition Days). Information will be disseminated through an initial visit to all households, and from then on either through (1) broadcast messages sent to households via mobile phone, (2) central individuals in the village social network who will be asked to spread that information, or (3) public officials charged with spreading the information throughout the village.
16001201|NCT02879708|Other|Information and Facilitation|In addition to the information interventions described above, this intervention will provide trained facilitators to help community members engage in a participatory process with VHSNCs and identify key deficiencies for improvement in health services that most concern community members. The facilitators are trained to help organize meetings and are provided a detailed checklist of activities to be undertaken prior to the the meetings. The three key health workers at the village level (ASHA, ANM, and AWW) report to the local (village level) elected representatives and block level authorities, who receive feedback from the community in the accountability interventions.
16001205|NCT02879682|Procedure|nTMS data available for the surgeon|the preoperatively acquired map of the motor cortex by nTMS will be available for the surgeon
16001206|NCT02879682|Procedure|nTMS data not available for the surgeon|the preoperatively acquired map of the motor cortex by nTMS will not be available for the surgeon
16001207|NCT02879669|Biological|ONCOS-102|
16001208|NCT02879669|Drug|Pemetrexed/cisplatin (carboplatin)|
16001209|NCT02879669|Drug|Cyclophosphamide|
16001210|NCT02879656|Procedure|non-operative treatment|conservative treatment with 5 weeks cast immobilization
16071127|NCT02374567|Drug|Triazolam|
16001212|NCT02879643|Drug|Marqibo|The focus of the study design and statistical analysis is to determine whether Marqibo® can be substituted for standard vincristine and successfully administered to patients with relapsed ALL in three different treatment cohorts: (A) treatment with the UK ALL R3 regimen; (B) treatment with UK ALL R3 regimen without mitoxantrone, and (C) treatment with ALL maintenance therapy. Secondary objectives include estimating rates of serious toxicities and therapy delays in each of these cohorts.
16001213|NCT02879617|Drug|durvalumab|A human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody directed against programmed cell death ligand 1 (PD-L1)
16001214|NCT02879604|Other|Compensatory cognitive training|In addition to the usual care, method of compensatory cognitive remediation
16001215|NCT02879604|Other|Usual|Usual care
16001216|NCT02879591|Other|Social Skills training with Avatar therapist|
16001217|NCT02879578|Drug|Valbenazine|
16001218|NCT02879565|Other|Semi structured interviews + EEG exams|
16001219|NCT02879552|Procedure|Traditional upper blepharoplasty|The skin incisions were marked using a skin marking pen. Preseptal orbicularis skin and muscle were removed using a size-15 scalpel blade and scissors. Hemostasis was achieved with conservative electrocuatery. The skin was closed with a running 6-0 nylon suture.
16001220|NCT02879552|Procedure|Brassiere suture with blepharoplasty|"Prior to skin closure as above, three 6-0 polyglactin sutures are passed along the lateral fourth of the orbital rim. The sutures attach the inferior orbicularis oculi edge to the arcus marginalis of lateral ROOF. Sutures are placed until there is a visible plumping of the sub-brow tissues."
16001221|NCT02879539|Device|MP3000 sound coding strategy or ACE strategy with lower stimulation|
16001222|NCT02879526|Drug|C-CPT|Chidamide 30mg ，twice a week Prednisone 20mg qd Cyclophosphamide 50mg qd Thalidomide 100mg qd
16001223|NCT02879513|Drug|Paclitaxel|
16001224|NCT02879513|Drug|Cisplatin|
16001225|NCT02879513|Drug|Epirubicin|
16001226|NCT02879513|Drug|Cyclophosphamide|
16001227|NCT02879513|Drug|5-fluoruracil|
16001228|NCT02879500|Other|Diet beverages|
16001229|NCT02879487|Device|Monopolar needle electrode|Colpotomy during total laparoscopic hysterectomy
16001230|NCT02879474|Behavioral|Melanoma scale questionnair|
16001231|NCT02879461|Procedure|LUMBAR DESCOMPRESSION|ATRODESIS AND DESCOMPRESSIO OFF VERTEBRAL CANAL
16001232|NCT02879448|Device|Amulet Left Atrial Appendage Occluder|Transcatheter left atrial appendage closure
16001233|NCT02879448|Device|WATCHMAN Left Atrial Appendage Closure|Transcatheter left atrial appendage closure
16001234|NCT02879435|Drug|Bupivacaine|pre-operative wound infiltration with 10 ml of numbing medicine
16001235|NCT02879435|Other|Placebo|pre-operative wound infiltration with 10 ml of sterile water
16001236|NCT02879422|Genetic|genetic analysis|
16001237|NCT02879409|Drug|Metformin|Initial: 500 mg once daily; dosage may be increased by 500 mg weekly; maximum dose: 2,000 mg once daily
16001238|NCT02879409|Drug|Gliclazide|"There is no fixed-dosage regimen for the management of diabetes mellitus with gliclazide. Dose will be individualized based on frequent determinations of blood glucose during dose titration and throughout maintenance. The 30 mg modified-release tablet equals the 80 mg immediate-release tablet.
~Immediate-release tablet: Initial: 80 mg twice daily; titrate based on blood glucose levels. Usual dosage range: 80 to 320 mg/day (maximum dose: 320 mg/day); dosage of ≥160 mg should be divided into 2 equal parts for twice-daily administration.
~Modified-release tablet: Initial: 30 mg once daily; titrate in 30 mg increments every 2 weeks based on blood glucose levels. Maximum dose: 120 mg once daily"
16001239|NCT02879409|Drug|Sitagliptin|Oral: 100 mg once daily
16001240|NCT02879409|Drug|Liraglutide|SubQ: Initial: 0.6 mg once daily for 1 week; then increase to 1.2 mg once daily; may increase further to 1.8 mg once daily if optimal glycemic response not achieved with 1.2 mg daily.
16001241|NCT02879409|Drug|Pioglitazone|"Oral, Monotherapy or combination therapy: 15-30 mg once daily
~Patients with heart failure (NYHA Class I or II): Monotherapy or combination therapy: 15 mg once daily"
16001242|NCT02879409|Drug|Dapagliflozin|5mg once daily increasing to 10mg once daily as required
16001243|NCT02879409|Drug|human insulin|insulin dosage and administration according to physician
16001244|NCT02879396|Behavioral|PA4LE Program|"Medication self-management including medication reconciliation, therapy recommendations, and education by pharmacist (chronic conditions and medications including Beers Criteria)
~Use of a patient-centered health record that helps guide patients through the care process (portable, health and medication record for elders)
~Primary care provider and specialist follow-up (patient awareness of discharge action plan and follow-up)
~Patient understanding of red flag indicators of worsening condition and appropriate next steps
~Behavioral interventions - Adherence, Lifestyle modifications, Mindfulness & Lovingkindness meditations to combat anxiety, insomnia and other behavioral symptoms"
16001245|NCT02879383|Procedure|DMR Procedure|The DMR procedure consists of hydrothermal ablation of the duodenum using the Revita System
16001246|NCT02879383|Procedure|Sham Procedure|The sham procedure consists of placing the Revita Catheter into the stomach for 30 minutes and then removing it from the patient.
16001247|NCT02879370|Procedure|Transanal Inspection and management of low ColoRectal Anastomosis|Low anterior resection with total mesorectal excision (TME), either performed open, laparoscopic or robotic Closure of the rectum with linear or curved stapler with transanal inspection Transanal placement of four 2-0 prolene sutures on the rectal stump, respectively 2 at the extremities of the suture line (left and right) and other two 1 cm medial to each of the previous two sutures Circular stapler is introduced, the 4 tails of the prolene stitches are introduced through the windows (2 in the left and 2 in the right side of the instrument) and gently pulled, to obtain a gradual and homogeneous traction of the tissue and elimination of both previous suture lines and doggy ears, then the stapler is fired The termino-terminal anastomosis is carefully inspected A leak test can be performed (if negative the protective stoma is not performed) An eventual leak can be transanally repaired
16001248|NCT02879357|Behavioral|Training|"Clinician training
~System for patient selection
~System of triggering and tracking conversations
~Training on how to use the Serious Illness Care Guide, a guide for patients about initiating conversations with family members about end-of-life goals and values
~Longitudinal Medical Record (LMR) documentation module to serve as a Single source of truth about advance care preferences in the LMR."
16001249|NCT02879344|Other|Blood draw|
16001250|NCT02879331|Procedure|10 coils in upper lobes|
16001258|NCT02879305|Drug|rhEPO|The initial ESA dose is based on converting the prior ESA dose to the nearest available study rhEPO dose and is administered IV. The dose is adjusted thereafter in order to achieve the target range.
16001259|NCT02879305|Drug|Placebo|Oral placebo tablets will be taken from Week -4 up to randomization (Day 1).
16001260|NCT02879305|Drug|Iron therapy|Participants will receive supplemental iron therapy if ferritin is <=100 ng/mL or TSAT is <=20%. The investigator will choose the route of administration and dose of iron.
16001261|NCT02879292|Other|Spinal anesthesia|Spinal Anesthesia
16001262|NCT02879279|Device|Amadeo, Pablo, Diego and Motore.|In the robotic rehabilitation group, patients will be treated with the following systems: Amadeo, Pablo and Diego (Tyromotion GmbH, Austria), and Motore (Humanware, Italy). A ratio of one therapist to every 3 or 4 patients will be used, depending on the patient's severity. The rehabilitation treatment will be performed daily for 45 minutes, for 5 days per week, for 6 weeks. A total of 30 sessions will be performed.
16001263|NCT02879279|Other|Conventional rehabilitation|In the conventional rehabilitation group, patients will undergo a conventional treatment with a ratio of one therapist to one patient. The rehabilitation treatment will be performed daily for 45 minutes, for 5 days per week, for 6 weeks. A total of 30 sessions will be performed.
16001264|NCT02879266|Biological|TetraVax-DV TV005|Contains 10^3 plaque-forming units (PFUs) of rDEN1Δ30, 10^4 PFUs of rDEN2/4Δ30(ME), 10^3 PFUs of rDEN3Δ30/31-7164, and 10^3 PFUs of rDEN4Δ30; administered by subcutaneous injection in the deltoid region of the upper arm
16001265|NCT02879266|Biological|Placebo|Administered by subcutaneous injection in the deltoid region of the upper arm
16001266|NCT02879240|Other|Animated Cartoon|An animated cartoon chosen by the parents is displayed on a smartphone attached on the spacer of the child.
16001267|NCT02879240|Other|Black screen|A video displaying a black screen is used as control, and displayed on a smartphone attached on the spacer of the child.
16001268|NCT02879227|Drug|Cisplatin|Arm cisplatin : 75mg/m2, day n*1 and day n*22, And radiotherapy 50 Gy, 2Gy/f
16001269|NCT02879227|Drug|Oxaliplatin|85 mg/m2 every 2 weeks, 6 times And radiotherapy 50 Gy, 2Gy/f
16001270|NCT02879214|Radiation|Simultaneous boost along with chemo|Prior studies have utilized a sequential boost to deliver a total dose of 55 - 60 Gy to the pelvic sidewall (covering the lower pelvic lymph nodes), including 8-10 Gy that is usually delivered with brachytherapy (1-3), the studies often use single drug. This study treatment plan will use dose intensify in both chemotherapy and radiation. The chemotherapy have two drugs regimens of mitomycin with cisplatin or taxol with cisplatin along of radiation dose escalate, the RT dose escalation to biological GTV defined by PET scan to dose of 57.50 Gy in 25 fx while the elective volumes are held constant at 45 Gy.
16001271|NCT02879201|Procedure|Slow efficiency dialysis|Slow dialysis 4 times weekly 8 hours CVVHDF predilution mode
16001272|NCT02879188|Other|Physical Therapy|Patients will initiate inpatient physical therapy on the day of their surgery including attempted ambulation with an assistive device that is supervised by a physical therapist.
16001273|NCT02879188|Other|Standing|Patients will initiate inpatient physical therapy on postoperative day 1. On the day of their surgery they will dangle their feet over the edge of the bed with supervision of nursing.
16001274|NCT02879162|Drug|Durvalumab|
16001275|NCT02879162|Drug|Tremelimumab|
16001276|NCT02879149|Device|AUGMENT® Bone Graft|AUGMENT® Bone Graft
16001277|NCT02879149|Procedure|Standard of Care|Autologous Bone Graft
16001278|NCT02879136|Drug|Methylphenidate|Patient will be randomized to Methylphenidate
16001279|NCT02879136|Other|Physical Therapy|All Patients will have standard of care PT used for PD patients
16001280|NCT02879136|Drug|Atomoxetine|Patient will be randomized to Atomoxetine
16001281|NCT02879110|Dietary Supplement|Sulforaphane|Sulforaphane (SFN) is a compound within the isothiocyanate group of organosulfur compounds. It is obtained from cruciferous vegetables such as broccoli, Brussels sprouts or cabbages.
16001282|NCT02879110|Other|Placebo|Placebo tablet is composed of starch.
16001283|NCT02879097|Biological|CBT124|Induction Phase: CBT124 15 mg/kg IV infusion-Day 1 of each 3-week Cycle for 6 cycles; Carboplatin AUC 6 mgXmin/mL (calculation-Calvert formula recommended) on Day 1 of each 3-week Cycle for 6 cycles; Paclitaxel 200 mg/m2 on Day 1 of each 3-week Cycle for 6 cycles. Maintenance Phase: All the subjects who complete the induction phase and are alive at Week 19 without progression of the disease can be included in the maintenance phase and receive CBT124 (bevacizumab, 15 mg/kg, intravenous infusion on Day 1 of each 3-week Cycle) up to disease progression or unacceptable toxicity (that precludes further treatment with bevacizumab) or death.
16001284|NCT02879097|Biological|EU-sourced Avastin®|Induction Phase: EU-sourced Avastin® 15 mg/kg IV infusion-Day 1 of each 3-week Cycle for 6 cycles; Carboplatin AUC 6 mgXmin/mL (calculation-Calvert formula recommended) on Day 1 of each 3-week Cycle for 6 cycles; Paclitaxel 200 mg/m2 on Day 1 of each 3-week Cycle for 6 cycles. Maintenance Phase: All the subjects who complete the induction phase and are alive at Week 19 without progression of the disease can be included in the maintenance phase and receive CBT124 (bevacizumab, 15 mg/kg, intravenous infusion on Day 1 of each 3-week Cycle) up to disease progression or unacceptable toxicity (that precludes further treatment with bevacizumab) or death.
16001285|NCT02879097|Drug|Carboplatin|Induction Phase: Carboplatin AUC 6 mgXmin/mL (calculation-Calvert formula recommended) on Day 1 of each 3-week Cycle for 6 cycles.
16001286|NCT02879097|Drug|Paclitaxel|Induction Phase: Paclitaxel 200 mg/m2 on Day 1 of each 3-week Cycle for 6 cycles.
16001287|NCT02879058|Procedure|Intraoperative contact ultrasonography|In patients randomized to myomectomy with contact ultrasonography, the laparoscopic or robotic ultrasound probe will be advanced through an existing port site into the pelvis after traditional myomectomy has been performed. The face of the ultrasound transducer will be guided over the uterus (including open hysterotomy sites) in systematic strokes, taking special care to note locations of myomas that may have been missed by the preceding excision. Additional hysterotomy sites will be made as necessary in order to remove persistent myomas. Any number of additional ultrasound passes and excisions may be performed in order to achieve the most comprehensive removal of myomas.
16001361|NCT02878382|Other|Conventional MAL-PDT|Curettage of lesions and application of MAl cream 16% for 90 minutes under occlusion followed by LED 635 nm illumination at 37 J/cm2 total dose
16001436|NCT02877784|Other|Functional Oral Intake Scale|The Functional Oral Intake Scale (FOIS) will be used for participants to report their food intake habits.
16071128|NCT02374567|Drug|Lormetazepam|
16001288|NCT02879045|Other|Elasticity Belly® oil|We will enroll about 50 Nulliparous women randomly, who are in their second trimester of pregnancy. We divide each of the volunteer's abdomen skin into two parts through medioventral line, one of the abdomen skin will receive the elasticity Belly® oil to prevent striae gravidarum, and the other side will use the Clarins® oil. Volunteers apply these two kinds of oil daily until birth. We'll take abdomen pictures before and after interventions, and the occurrence of striae on abdominal skin and its severity will be evaluated as our primary end point of the study.
16001289|NCT02879019|Other|Stretching exercise group|In each stretching class, approximately 20 exercises will be performed. The total duration of the session will be approximately 30 minutes.
16001290|NCT02879019|Other|Walking training group|Patients will perform two walking session per week, each consisting of 15*2-min walking bouts, with 2-min of rest in between. The intensity will be set at heart rate corresponding to the pain threshold.
16001291|NCT02879006|Drug|Chinese Herbal Medication|Capsules, 26 month course, starting 2 months pre-OIT
16001292|NCT02879006|Drug|Placebo|Placebo capsules that look identical to E-B-FAHF-2, 26 month course, starting 2 months pre-OIT
16001293|NCT02879006|Drug|Omalizumab|4 months course, starting 2 months pre-OIT through the 2 month build-up phase
16001294|NCT02879006|Drug|Multi OIT|24 months of multi OIT (maintenance dose of 1gm each food allergen)
16001295|NCT02878993|Device|Recording of diaphragm EMG|Recording of diaphragm EMG prior to extubation using surface diaphragm electromyography
16001296|NCT02878980|Behavioral|Exercise Intervention|Undergo supervised 1-on-1 exercise sessions
16001297|NCT02878980|Other|Laboratory Biomarker Analysis|Correlative studies
16001298|NCT02878980|Other|Quality-of-Life Assessment|Ancillary studies
16001299|NCT02878980|Other|Questionnaire Administration|Ancillary studies
16001300|NCT02878954|Other|No intervention (Observational study)|"160 patients will be recruited to:
~Fill in questionnaires related to demographic characteristics, severity of disease and physical activity.
~Perform a six-minute walk test Comparison between men and women will be performed."
16001301|NCT02878954|Other|Control session|"Out of the 160 participants of the observational study, at least 40 (20 men and 20 women) will be recruited.
~In the control session participants will be seated in resting position for 15 minutes."
16001302|NCT02878954|Other|Exercise session|40 patients will perform a single maximal exercise test on a treadmill. Speed will be maintained at 3.2 km/h and the grade will be increased with 2% every 2 min following Gardner's protocol.
16001303|NCT02878941|Procedure|Synovial Fluid Analysis|Synovial fluid aspiration (act of using an 18 gauge needle to obtain synovial fluid from the elbow) in the emergency room for patients with the eligible elbow fracture (as defined in inclusion/exclusion criteria) is performed in conjunction with the anesthetic injection as part of standard of care. The elbow will be prepped as per usual for the anesthetic injection. An 18 gauge needle will be inserted through a lateral approach. The subject's elbow will be aspirated. The syringe with the aspirate would be removed from the needle while the needle would remain in the subject's elbow joint. The syringe with anesthetic would then be connected to the needle, and the anesthetic would be injected into the elbow joint. Therefore, no risks from a separate aspiration would be conferred to the patient.
16001304|NCT02878928|Genetic|IDgenetix Neuropsychiatric Test Panel|The IDgenetix Neuropsychiatric Test Panel is used to make recommendations on the medication therapy that might be impacted by the genetic background of the patient.
16001305|NCT02878915|Device|Ultrasound guided femoral puncture|
16001306|NCT02878902|Other|Post implementation|Patient group whose care course was organized by the nurse coordinator of chronic renal failure
16001307|NCT02878889|Drug|S-1|
16001308|NCT02878876|Dietary Supplement|Oral consumption of milk with sequence A1-A2|Oral consumption of 300 ml of milk containing both A1 and A2 type beta casein at 8:00 a.m. on Visit 1 (after 12-hour fasting) and 300 ml of milk containing only A2 type beta casein at 8:00 a.m. on Visit 2 (after 12-hour fasting).
16001309|NCT02878876|Dietary Supplement|Oral consumption of milk with sequence A2-A1|Oral consumption of 300 ml of milk containing only A2 type beta casein at 8:00 a.m. on Visit 1 (after 12-hour fasting) and 300 ml of milk containing both A1 and A2 type beta casein at 8:00 a.m. on Visit 2 (after 12-hour fasting).
16001310|NCT02878863|Drug|Paeoniflorin + phosphatidylcholine or silymarin|
16001311|NCT02878863|Drug|Phosphatidylcholine or silymarin|
16001312|NCT02878850|Other|Augmented Blood Pressure|Subjects will have their blood pressure kept in a higher range.
16001313|NCT02878837|Drug|Dexmedetomidine|
16001314|NCT02878837|Drug|Midazolam|
16001315|NCT02878824|Other|Ethnicity|"As mentioned by Goldberger and Veroff (1995) the concept of ethnicity is also associated with culture and is often used interchangeably with culture as well as with race. Ethnic differences are not necessarily inherited, but they are learned through constant exposure; however have strong genetic influences that explain consequent behavioural differences between different ethnic groups (Chudek & Henrich, 2011). An individual's genetic makeup greatly affects their behaviours (Klahr & Burt, 2014).
~In this study, we look at exposure to different ethnicity as exemplified by comparison between two groups of typically-developing children from different ethnicity (Chinese children in Hong Kong and Filipino Children in Hong Kong)."
16001316|NCT02878824|Other|Environment|The living environment has been implicated to have an effect on a person's psychological functioning (Rutter, Picker, Murray & Eaves, 2001) and eventually how behaviour is manifested. The proposed disparity or effects between urban and rural dwelling is built on research that looks at the restorative and calming features of the natural environment, as well as the chaotic organization of the living spaces in urban settings.
16001317|NCT02878811|Other|Observational study|This is a non-interventional study, patients receive their usual treatment as determined by the physician.
16001318|NCT02878798|Drug|topiramate|Oral topiramate at a target dose of 50mg twice daily.
16001319|NCT02878798|Other|Placebo|overencapsulated placebo of identical color, shape and packaging to topiramate
16001320|NCT02878785|Drug|Decitabine|DNA methyltransferase inhibitor
16001321|NCT02878785|Drug|talazoparib|poly ADP ribose polymerase (PARP) inhibitor
16001322|NCT02878772|Drug|vinpocetine|30 mg of the drug by intravenous infusion once daily, for fourteen consecutive days, beginning within one hour after the baseline MRI and no later than 48 hours after the onset of symptoms.
16001323|NCT02878772|Drug|Aspirin|100mg, once daily, oral medication
16071129|NCT02374567|Drug|Temazepam|
16001324|NCT02878759|Device|Wristbot|The proposed technology comprises a hardware device with four motors that can apply torques to the human wrist about its three degrees of freedom (i.e. axes of rotation: wrist flexion/extension,abduction/adduction and forearm pronation/supination). This allows for guided and controlled movements of the wrist by delivering assistive, resistive, perturbation or no forces (patient actively moves the wrist). It contains a set of specialized software modules that a) allow for the objective, psychophysical assessment of sensory dysfunction in patients, and b) provide specialized training modules designed to improve sensory and motor functions of the wrist.
16001325|NCT02878746|Device|Robotic mirror therapy|2-dimensional
16001326|NCT02878746|Device|Conventional mirror therapy|2- and 3-dimensional
16001327|NCT02878733|Drug|Albumin|patients that had either received any volume of 5% albumin in addition to at least 500mL of any crystalloid (0.9% saline, buffered salt solutions such as Plasma-Lyte, Lactated Ringers etc.)
16001328|NCT02878720|Device|Transcutaneous vagal nerve stimulation|"The stimulation of the auricular branch of the vagus nerve will be performed through an electric stimulator and two Ag-AgCl electrodes placed in the left external acoustic meatus at the inner side of the tragus. For sham stimulation, electrodes will be attached to the left ear lobe. tVNS will be delivered as trains lasting 30 s and composed by 600 pulses (intra-train pulse frequency = 20 Hz; pulse duration = 0.3 ms) repeated every 5 min for 60 min. The intensity of stimulation will individually adjusted to a level ranging above the detection threshold and below the pain threshold. In this range, when possible, the investigators will chose an intensity of 8 mA.
~Each day, for 10 consecutive working days, each patient will receive a session of robotic therapy during the real or sham tVNS stimulation"
16001329|NCT02878707|Drug|Dexmedetomidine|Intraoperative dexmedetomidine infusion
16001330|NCT02878694|Biological|Myoblast autologous graft|30 million autologous myoblasts in 6 intramuscular injections No treatment in the second eye
16001331|NCT02878681|Drug|Ranibizumab|0.5 mg intravitreal injections
16001332|NCT02878681|Drug|Aflibercept|2 mg intravitreal injections
16001333|NCT02878668|Procedure|hepatopancreatobiliary surgery|hepatopancreatobiliary surgery
16001334|NCT02878629|Device|Mandibular Advancement Devices|
16001335|NCT02878616|Drug|LFG316|LFG316 single dose
16001336|NCT02878616|Drug|IVIG|IVIG single dose
16001337|NCT02878603|Biological|caplacizumab|
16001338|NCT02878590|Device|BONGO DEVICE|A device to be used for the treatment of mild to moderate obstructive sleep apnea
16001339|NCT02878577|Device|fMRI|fMRI scans, mapping brain connectivity using EEG in combination with eye-tracking technology (Brain Network Activation (BNA) technology developed by ELMINDA), characterizing of cortical layers using magnetic resonance (the CoLI technology developed by Tel-Aviv University), and Diffusion Tensor Imaging (DTI) imaging (imaging of brain tracks).
16001340|NCT02878564|Drug|Praziquantel|40 mg/kg, PO (orally administered tablets)
16001341|NCT02878551|Other|Prehabilitation program|multimodal prehabilitation intervention composed of exercise, nutritional supplement and psychological well-being
16001342|NCT02878538|Drug|Deferiprone|Subjects will then begin an experimental No1 design: placebo-deferiprone-placebo. Study drug will be administered in three 3 month blocks. All subjects will receive 30 days of active study drug. The placebo-deferiprone contrast compares placebo to active drug initiation. The deferiprone-placebo contrast tests active drug withdrawal. All will be given placebo in months 1-3, and 6-12. This will allow the investigators to examine active drug exposure on d score up to one year and prospective time to MCI conversion. Dosing: Participants will be treated 25 mg/kg po tid (75mg /kg /d total) The dose will be rounded by the prescriber to the nearest 250 mg (half-tablet).
16001343|NCT02878538|Other|Placebo phase|Placebo tablets with inactive substance will be provided to subjects for two, 3 month blocks during the study.
16001344|NCT02878525|Procedure|Laparoscopic internal gastric banding|Laparoscopic internal gastric banding
16001345|NCT02878525|Procedure|laparoscopic sleeve gastrectomy|laparoscopic sleeve gastrectomy
16001346|NCT02878512|Procedure|PCNL under General Anesthesia|Patients undergoing percutaneous Nephrolithotomy received General anesthesia.
16001347|NCT02878512|Procedure|Segmental Epidural Anesthesia|Patients undergoing PCNL surgery received Segmental epidural anesthesia with 0.5% bupivacaine.
16001348|NCT02878499|Other|polysomnography|
16001349|NCT02878486|Device|Jawbone Up|Jawbone Up is a wrist wore water resistant activity monitor.
16001350|NCT02878486|Behavioral|Physical Activity Education|A study team member will discuss benefits of changing sitting habits and ways to make changes to personal habits.
16001351|NCT02878486|Device|ActivPAL|Devices measures postural changes over time. Participants will wear device for 7 days. The device measures time sitting, standing, and posture changes (i.e. sit-to-stand).
16001352|NCT02878473|Procedure|Deceased donor Liver Transplantation|Deceased donor orthotopic liver transplantation
16001353|NCT02878460|Other|monitoring with ORI + SpO2|"If ORI is equal to 0.00, the FiO2 (or oxygen flow) is not changed. if ORI is ≥ 0.01, Nurses must decrease the FiO2 (or oxygen flow) by 10%, until ORI is =0.
~if SpO2 is < lower individualized limit, FiO2 (or oxygen flow) is increased by 10%, if it happens twice, doctors are called."
16001354|NCT02878460|Other|monitoring with SpO2|"If SpO2 is below the upper individualized limit, the FiO2 (or oxygen flow) is not changed.
~If SpO2 is equal or above this limit, Nurses must reduce the FiO2 (or oxygen flow) by 10% every 10 minutes until SpO2 is ≤ upper individualized limit, with FiO2≥25 %.
~if SpO2 is < lower individualized limit, FiO2 (or oxygen flow) is increased by 10%, if it happens twice, doctors are called."
16001355|NCT02878447|Radiation|External beam radiotherapy|External beam radiotherapy will be prescribed to a central plane using mega-voltage radiation encompassing all the assessed affected lung tissue at 3.5Gy weekly for 5 fractions to a maximum of 17G
16001356|NCT02878421|Device|electronic cigarette + 16mg nicotine & flavor|comparison of different strengths of nicotine
16001357|NCT02878421|Other|electronic cigarette + 0mg nicotine & flavor|comparison of different strengths of nicotine
16001358|NCT02878421|Other|Tobacco cigarette|Participant to remain on traditional cigarettes for 28 days
16001359|NCT02878408|Genetic|Blood sampling|supplementary blood sampling for analysis of: immuno-genetic, inflammatory process, retro-viruses activity, Questionaries about environment risk factors
16001360|NCT02878395|Procedure|Ileocolic resection|
16001431|NCT02877823|Behavioral|Control|Healthy Lifestyle Education
16002214|NCT02872116|Drug|Fluorouracil|Specified dose on specified days
16001362|NCT02878382|Other|Calcipotriol assisted MAL-PDT|Calcipotriol 50 mcg/g for 15 days prior to PDT. Curettage of lesions and application of MAl cream 16% for 90 minutes under occlusion followed by LED 635 nm illumination at 37 J/cm2 total dose
16001363|NCT02878369|Procedure|Doppler measurement of blood flow in the outflow tract of the left ventricle and the femoral artery,Reading blood pressures displayed on the monitor.|
16001364|NCT02878356|Behavioral|Regular MI-training|Regular training (n= 59) the Motivational Interviewing (MI) -training methods used in the Swedish county councils and municipalities
16001365|NCT02878356|Behavioral|Regular MI-training + supervision half|Regular MI-training followed by six individual MI-supervision sessions at monthly intervals based on only the behavior counts component of MITI (n= 58)
16001366|NCT02878356|Behavioral|Regular MI-training + supervision full|Regular MI-training followed by MI-supervision based on both the behavior counts and the five global dimensions of MITI (n= 58)
16001367|NCT02878343|Behavioral|Incentives|Daily lottery type incentives tied to achievement of weight loss goals
16001368|NCT02878343|Behavioral|Environmental strategies|Individually tailored environmental strategies around food intake and physical activity; automated text/emails sent from study website platform
16001369|NCT02878330|Drug|MEDI8897|A single IM dose of 50 mg on Day 1 of the study.
16001370|NCT02878330|Drug|Placebo|A single IM dose of placebo matched to MEDI8897 on Day 1 of the study.
16001371|NCT02878291|Biological|Meningococcal ACYW135 Polysaccharide Conjugate Vaccine|Group 1:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 10 µg each of Serogroup A, C, Y, and W135 polysaccharide conjugated to Tetanus Toxoids.
16001372|NCT02878291|Biological|Meningococcal ACYW135 Polysaccharide Conjugate Vaccine|Group 2:3/2/1 dose(s) according to age of subjects. Single intramuscular dose contains 5 µg each of Serogroup A, C, Y, and W135 polysaccharide conjugated to Tetanus Toxoids.
16001373|NCT02878278|Drug|Chidamide BIW|Chidamide is given 30mg, twice a week
16001374|NCT02878278|Drug|Chidamide QD|Chidamide is given 10mg,QD
16001375|NCT02878265|Dietary Supplement|Vitamin A|Vitamin A supplements
16001376|NCT02878265|Dietary Supplement|Vitamin A and ZInc|Combination of vitamin A and zinc supplements
16001377|NCT02878265|Dietary Supplement|Vitamin A , Zinc and Multivitamin|Combination of vitamin A, zinc and multivitamins
16001378|NCT02878239|Other|Steps 1|Kinematic characteristics are obtained by the portal gait analysis system in the patients. Kellgren-Lawrence Scores are obtained according to their radiography.
16001379|NCT02878239|Other|Steps 2|Kinematic characteristics are obtained by the portal gait analysis system in the subjects.Physical examinations are taken to avoid other diseases.
16001380|NCT02878226|Procedure|repair of rupture|
16001381|NCT02878213|Device|D700 System|Atrial Fibrillation Ablation Procedure
16001382|NCT02878200|Biological|dihydroartemisinin-piperaquine|A treatment course of DHAP consists of three doses taken daily. Treatment doses for household members will be prepared based on measured weight
16001383|NCT02878187|Device|Doppler|"Color Doppler ultrasound will be used to demonstrate the main ascending branches of left and right uterine arteries as they cross over the hypogastric vessels just before they enter the uterus at the uterine-cervical junction. The high pass filter was set at 125 Hz and the uterine artery will be obtained immediately after the crossing of the hypogastric artery. The sample volume will be placed on the artery with an angle of about 0°. After detection of blood flow and visu¬alization of the waveform of the uterine artery, five blood flow indices will be automatically cal¬culated:
~The pulsatility index The resistance index The peak systolic velocity ; The end-diastolic velocity The time-averaged maximum"
16001384|NCT02878174|Procedure|internal jugular vein catheterization|internal jugular vein catheterization using ultrasound (US) or US-based prelocation techniques
16001385|NCT02878161|Drug|methotrexate(necessary)|Methotrexate will be received orally with dosage of 10mg/ week for every patient and MTX dose must be stable for at least 4 weeks.
16001386|NCT02878161|Biological|infliximab|infliximab :intravenous injection 200mg,every times,0,2,6,14week ,4 times)
16001387|NCT02878161|Biological|etanercept|Etanercept :hypodermic injection,25mg/twice a week
16001388|NCT02878161|Biological|adalimumab|Adalimumab:hypodermic injection,40mg/twice a week
16001389|NCT02878161|Drug|leflunomide (permitted, not necessary)|LEF will be permitted if patient had received for 1 month before enrollment and will not be changed for 14 weeks.
16001390|NCT02878161|Drug|NSAIDs (permitted,not necessary)|NSAIDs will be allowed if patient had received for 1 month before enrollment and will not be changed for 14 weeks.
16001391|NCT02878161|Drug|Glucocorticoids (permitted,not necessary)|Glucocorticoids (prednisone less than 10mg/day, or equal dosage of other similar drugs) will be permitted if the patient had received for 1 month before enrollment and the dosage will not be changed during the period.
16001392|NCT02878148|Device|Diagnostic imaging modalities for suspected renal colic|"All patients with suspected acute uncomplicated renal colic included will undergo ultrasonography in addition to unenhanced CT of pelvis and abdomen and plain X-ray of the abdomen.
~Imaging examination will be performed according to current guidelines.
~Ultrasonography study and colour doppler will include the kidney, ureterovesical joint and ureters. Unenhanced CT will be performed using a dedicated low-dose protocol."
16001393|NCT02878135|Procedure|fast application|
16001394|NCT02878135|Procedure|slow application|
16001395|NCT02878122|Procedure|Cancer treatment|Chemotherapy and laparoscopic surgery
16001396|NCT02878109|Device|Post-treatment phase group|4D-THRIVE and 4D-FLOW using magnetic resonance imaging (MRI)
16001397|NCT02878109|Device|Pre-treatment phase group|4D-THRIVE and 4D-FLOW using magnetic resonance imaging (MRI)
16001398|NCT02878096|Drug|[14C]-SK-1404|In Part 1, each subject will receive a single PO dose of SK-1404 followed by an IV microtracer dose of [14C]-SK-1404.
16001399|NCT02878083|Drug|VEDOLIZUMAB|Infusion at week 0 week 2 week 6 week 14 for all patients Infusion at week 22 for responder patient only
16001400|NCT02878083|Drug|ADALIMUMAB|For nonresponder patients only : Injection at week 22 week 24 week 26 and week 28
16001401|NCT02878070|Behavioral|Calls from a Peer Health Coach for 6 months|Weekly calls for 2 months, bi-weekly calls for 2 months, monthly calls for 2 months.
16001432|NCT02877810|Other|Telemedicine|Telemedicine is a live, interactive, audiovisual teleconferencing system.
16001433|NCT02877810|Other|Telephone|Consultations will be given over telephone.
16001402|NCT02878057|Drug|Apatinib|Dosing regimen: apatinib tablets: 500 mg, Po, QD; 4 weeks as a cycle, continuous treatment until disease progression, death or intolerable toxicity (giving endocrine therapy simultaneously if hormone receptor positive)
16001403|NCT02878044|Other|Thyroid Decision Aid|The Thyroid Decision Aid is a tool designed to help clinicians and patients discuss treatment options for thyroid nodules.
16001404|NCT02878031|Drug|Oral amoxicillin for CI pneumonia|"CHW management of chest indrawing (CI) pneumonia in children 2-59 months old using oral amoxicillin, given in the following age specific dosage:
~2 months ≤ children age <12 months (4 - <10kg): one (1) tablet 250mg dispersible amoxicillin twice daily (morning and evening) for 5 days.
~12 months≥ children age <3 years (10 kg - <14 kg): two (2) tablets 250mg dispersible amoxycillin taken twice daily (morning and evening) for 5 days.
~≥ 3 years of age children <5 years (14kg - 19kg): three (3) tablets 250mg dispersible amoxycillin taken twice daily (morning and evening) for 5 days."
16001405|NCT02878018|Drug|Qi-Ji Shen-Kang formula; Zhu-Bai formula; Yu-Shen formula|Qi-Ji Shen-Kang formula:15g of field thistle,10g of common edelweiss herb,10g of spreading hedyotis herb,10g ofYunnan manyleaf Paris rhizome,10g of hairyvein agrimonia herb,10g of the root bark of the tree peony,15g of root of red rooted salvia, and 15g ofmembranous mikvetch root.Zhu-Bai formula:10g of glabrous greenbrier rhizome,5g of Chinese atractylodes rhizome,10g of amur corktree bark,10g of common edelweiss her),10g of field thistle,10g of lalang grass rhizome,10g of garden burnet root,5g of longbract cattail pollen,5g of rehmanniae radix, and 5g of Chinese angelica root.Yu-Shen formula:15g of membranous mikvetch root,10g of heterophylla falsestarwort root,10g of field thistle,10g of cogongrass rhizome,10g of spreading hedyotis herb,10g of root of red rooted salvia,10g of fresh root of rehmannia,10g of Asian puccoon,10g of wormwoodlike motherwort herb,10g of common cockscomb inflorescence,10g of gordon euyale,10g of root bark of the tree peony, and 5g of licorice root.
16001406|NCT02878018|Drug|angiotensin-converting enzyme (ACE) inhibitor; adrenergic receptor binder (ARB); adrenal cortical hormone; Tripterygium wilfordii polyglycosidium; immunosuppressant|prednisone at a dose of 1-1.5 mg/(kg·d) and Tripterygium wilfordii polyglycosidium at a dose of 1 mg/(kg·d). For each patient, the specific Western medicines used and their doses may be adjusted at the discretion of his or her physician, but the classes cannot be changed.
16001407|NCT02878005|Device|Intubating Laryngeal Tube Suction|Intubating Laryngeal Tube Suction
16001408|NCT02878005|Device|Ambu AuraGain Laryngeal Mask|Ambu AuraGain Laryngeal Mask
16001409|NCT02877992|Procedure|Ovarian puncture|Donors and patients are subjected to ovarian puncture as part of their donation procedure or IVF treatment. Oocyte are retrieved in this procedure along with granulosa and cumulus cells. Donors and patients sign an informed consent in order to donate their granulosa and cumulus cells for the study.
16001410|NCT02877979|Drug|DS003 vaginal tablet|The trial will be conducted in three cohorts of 12 women each. In each cohort, participants will be randomised in a 3:1 ratio to receive either DS003 or placebo on Day 0 and Day 17. In each cohort, therefore, 9 participants will receive DS003 vaginal tablets and 3 participants will receive placebo vaginal tablets.
16001411|NCT02877979|Drug|Placebo|
16001412|NCT02877966|Dietary Supplement|Amixea|Amixea is a mixture of amino acids. It consists mainly of essential amino acids (EAA) that cannot be synthesized de novo by the organism, and therefore must be supplied in its diet.
16001413|NCT02877966|Other|Placebo|
16001414|NCT02877953|Behavioral|the prevention of complications post-TIPS|Continuous nursing through telephone follow-up, family visits, and WeChat guided patients to prevent gastrointestinal bleeding, infection and constipation ,intake quality low-protein diet, recognize minimal encephalopathy, monitor blood ammonia, return visit regularly, deal with adverse drug reactions of anticoagulant.
16001415|NCT02877940|Device|ProSeal Laryngeal mask airway|ProSeal was inserted in mechanically ventilated patients undergoing elective surgeries.
16001416|NCT02877940|Device|Laryngeal Tube Suction- Disposable|LTS-D was inserted in mechanically ventilated patients undergoing elective surgeries.
16001417|NCT02877940|Device|i-gel|i-gel was inserted in mechanically ventilated patients undergoing elective surgeries.
16001418|NCT02877927|Drug|Omadacycline|po tablets
16001419|NCT02877927|Drug|Linezolid|po tablets
16001420|NCT02877914|Other|Observational study|This is a non-interventional study, patients receive their usual treatment as determined by the physician.
16001421|NCT02877901|Drug|long acting tolterodine 4 mg|receive one tablet at bed time for 4 weeks
16001422|NCT02877901|Drug|placebo|one tablet at bed time
16001423|NCT02877888|Drug|fluoride varnish 22600ppm|topical application on teeth every 6months
16001424|NCT02877875|Behavioral|Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, and Conduct Problems|MATCH-ADTC (Chorpita & Weisz, 2009) is designed for children aged 6-15. Unlike most evidence-based treatments (EBTs), which focus on single disorder categories (e.g., anxiety only), MATCH is designed for multiple disorders and problems encompassing anxiety, depression, post-traumatic stress, and disruptive conduct, including the conduct problems associated with Attention-deficit/hyperactivity disorder (ADHD). MATCH is composed of 33 modules-i.e., specific treatment procedures derived from decades of research on EBTs. The various modules can be organized and sequenced flexibly to tailor treatment to each child's characteristics and needs.
16001425|NCT02877875|Other|Monitoring and Feedback System|For each child, the web-based MFS system provides weekly monitoring of the MATCH modules used and the child's treatment response, in two forms (a) changes on the Behavior and Feelings Survey and (b) changes in severity of the top treatment concerns identified by youths and caregivers. At the end of treatment, the MFS provides a complete record of modules used, and child treatment response, across all the weeks of treatment.
16001426|NCT02877875|Behavioral|Treatment as usual|Treatment in the UC condition will use the procedures therapists (e.g., school counselors) and their supervisors consider appropriate and believe to be effective.
16001427|NCT02877862|Behavioral|mAGIC app|7-day app to encourage uptake of genetic counseling
16001428|NCT02877849|Device|MRI: Brain Imaging data collection|This study has no intervention, it is observational. We will collect brain imaging data and behavioral assessments.
16001429|NCT02877836|Other|magnetic resonance imaging (fMRI)|To identify movement-related fMRI activation pattern in dystonic patients in comparison to healthy controls Assessment of white matter integrity in the corticospinal tract in a group og dystonic patients compared with the healthy control group
16001430|NCT02877823|Behavioral|Treatment|Healthy Lifestyle Education, bottled water, pedometer, family navigator service
16001437|NCT02877784|Other|Eating Assessment Tool-10|The Eating Assessment Tool-10 will be used for participant reporting of swallowing system severity.
16001438|NCT02877771|Device|t:slim insulin pump with predictive low glucose suspend|To assess the functionality of a predictive low glucose suspend (PLGS) system that uses Continuous Glucose Monitoring (CGM) values to suspend basal insulin delivery when hypoglycemia is predicted as well as resume basal insulin delivery once Continuous Glucose Monitoring (CGM) values begin to increase.
16001439|NCT02877758|Other|Tomorrowlabs cosmeceutical formulation|
16001440|NCT02877758|Other|Sham cosmeceutical formulation|
16001441|NCT02877745|Other|Stratification, no intervention|
16001442|NCT02877732|Device|EYE-SYNC eye-tracking|The EYE-SYNC® portable eye-tracking system. The eye tracker is a handheld isolated display environment with embedded eye tracking sensors. The eye tracker is connected to a high-performance Windows tablet though a customized docking station. Included accessories with EYE-SYNC are a U.S. tablet power supply adapter and disposable sanitary masks. Participants are asked to follow a dot with their eyes, as the dot moves on the screen of the EYE-SYNC device.
16001443|NCT02877732|Other|SCAT-3 subtests|Following subtests of SCAT-3 will be administered to the participant: Symptom, Balance, Orientation and Immediate memory
16001444|NCT02877732|Other|DEM|Participant will be asked to read list of numbers out loud from a card
16001445|NCT02877732|Other|Simple Reaction Time subtest of ANAM-SRT|Participants will perform Simple Reaction Time sub-test of ANAM-SRT test. They will be asked to click the mouse button every time they see an asterisk on the screen. Participants will perform ANAM-SRT 1 and ANAM-SRT 2 in this study.
16001446|NCT02877732|Other|Level of Alertnesss|Participants will answer questions. This assessment is to assess their alertness level.
16001447|NCT02877719|Other|Questionnaires|Participants were asked to respond to the Chinese version of the Center for Epidemiologic Studies Depression Scale for Children, the Rosenberg self-esteem scale, and the Pediatric Quality of Life Inventory.
16001448|NCT02877706|Other|no specific intervention|
16001449|NCT02877693|Radiation|Thoracic MRI Scan|is to demonstrate the MRI scan will not adversely affect the functionality of the ICD system. To do so, the ICD system will be exposed to MRI scan of thoracic region, where the radiofrequency (RF) component of the scan is maximized.
16001450|NCT02877680|Behavioral|T1Doing Well|Strengths-based mobile health (mHealth) app for parents of adolescents with type 1 diabetes, which will prompt parents to recognize and reinforce their adolescents' diabetes-related strength behaviors
16001451|NCT02877667|Device|planar acoustic wave device|accessory to laser treatment
16001452|NCT02877654|Procedure|colonoscopy with biopsies in the left colon to assess intestinal permeability|"Eleven colonic biopsies are taken in the left colon during colonoscopy. Intestinal permeability is assessed by western blot, qPCR and immunofluorescence for claudin; occludin and ZO-1.
~One blood sample is taken to assess plasmatic zonulin (ELISA kit)."
16001453|NCT02877641|Dietary Supplement|Cholecalciferol|Given PO
16001454|NCT02877641|Other|Laboratory Biomarker Analysis|Correlative studies
16001455|NCT02877641|Dietary Supplement|Multivitamin|Given PO
16001456|NCT02877641|Other|Placebo|Given PO
16001457|NCT02877641|Other|Questionnaire Administration|Ancillary studies
16001458|NCT02877628|Other|Pharmacokinetic-pharmacodynamic model in liver transplantation|Biological: tacrolimus and calcineurin dosage, donor and recipient CYP3A5 and ABCB1 genotypes determination
16001459|NCT02877615|Drug|S 44819 150 mg twice a day|One sachet of S 44819 150 mg and one sachet of placebo twice a day
16001460|NCT02877615|Drug|S 44819 300 mg twice a day|Two sachets of S 44819 150 mg twice a day
16001461|NCT02877615|Drug|Placebo|Two sachets of placebo twice a day
16001462|NCT02877602|Device|MRI|
16001463|NCT02877602|Device|Transient Elastography|
16001464|NCT02877589|Other|hepatitis B virus (HBV) and hepatitis C virus (HCV) serologies and a screening questionnaire to detect risk factors of hepatitis B virus (HBV) and hepatitis C virus (HCV)|
16001465|NCT02877576|Procedure|Implantation of mixed intracerebral electrodes|"5 macro electrodes with micro electrodes are implanted in internal temporal structures (amygdala, anterior and posterior hippocampus, rhinal cortex, posterior para-hippocampal gyrus).
~Each electrode has 8 microcontacts, each recording the activity of 0 to 3 neurons (activity of 0 to 120 neurons/patient)."
16001466|NCT02877576|Behavioral|Face detection|Visualization of images of 60 unknown faces and 60 objects that are not faces (object, house, scene, animal, plant, word, letter…). Each image is showed for 500 ms and separated from following image by black screen of 1500 ms. In order to keep patient attention on image, patient will be asked to push a button at color change of fixation cross in the centre of image.
16001467|NCT02877576|Behavioral|Face individualization|"Visualization of images of celebrities (persons known by patient), showed randomly. Each image is showed for 500 ms and separated from following image by black screen of 1500 ms. In order to keep patient attention on image, patient will be asked to push a button at color change of fixation cross in the centre of image.
~Several celebrities are showed, with for each the presentation of 60 images different from that celebrity. 1 to 3 celebrities are showed (60 to 180 total images)."
16001468|NCT02877563|Other|Contrast ultrasound perfusion imaging of the limb|Contrast enhanced ultrasound imaging at rest and during contractile exercise will be performed prior to revascularization and 3-4 weeks after revascularization.
16001469|NCT02877550|Drug|Obinutuzumab|Obinutuzumab: 1000 mg, i.v. infusion; d1, 8, 15 C1 and d1 C2-6
16001470|NCT02877550|Drug|Venetoclax|p.o. once daily according to dose level (DL) or MTD
16001471|NCT02877537|Drug|Salbutamol|bronchodilation obtained with 2 inhalations of salbutamol (100 µg per dose) with inhalation chamber
16001472|NCT02877537|Procedure|Forced oscillation technique|before and after bronchodilation
16001473|NCT02877537|Procedure|Plethysmography|
16001474|NCT02877524|Other|Adaptive support ventilation|ASV during NIV
16001475|NCT02877524|Other|Pressure support ventilation|PSV during NIV
16001476|NCT02877511|Drug|BAY987517|Applied liberally to the skin (Formulation: Y73-161
16001477|NCT02877511|Drug|Sunscreen Lotion (Y65-110)|Applied liberally to the skin
16001478|NCT02877498|Other|Adaptive support ventilation|Adaptive support ventilation during invasive mechanical ventilation
16001479|NCT02877498|Other|Volume controlled ventilation|Volume controlled ventilation during invasive mechanical ventilation
16001481|NCT02877485|Drug|Ayr saline nasal mist|110mcg (2 sprays) sprayed to both nostrils daily for 42 days.
16001482|NCT02877472|Device|porous tantalum rod|Patients with avascular necrosis of the femoral head after femoral head fracture surgery receive treatment of core decompression and porous tantalum rod implantation
16001483|NCT02877472|Procedure|core decompression|Patients with avascular necrosis of the femoral head after femoral head fracture surgery will undergo core decompression.
16001484|NCT02877459|Device|AeriSeal System|Subjects will undergo two bronchoscopy procedures two months apart and will be treated with AeriSeal foam unilaterally, in two sub-segments during each bronchoscopy (4 segments treated in total).
16001485|NCT02877433|Device|Roxolid short implant, 4 mm length (4)|Placement of a combination of four short implants (in positions 35/45, 36/46) as distal support and two implants of conventional length (in positions 33/43) in the interforaminal region, in order to support a cross-arch fixed screw-retained prosthesis.
16001486|NCT02877433|Device|Roxolid short implant, 4 mm length (2)|Placement of a combination of two short implants (in positions 36/46) as distal support and two implants of conventional length (in positions 33/43) in the interforaminal region, in order to support a cross-arch fixed screw-retained prosthesis.
16001487|NCT02877420|Other|Non-Technical Skills Training Curriculum|
16001488|NCT02877420|Other|Conventional Simulation Training Group|
16001489|NCT02877407|Procedure|patient who undergo laparoscopic/robotic-assisted hysteropexy|
16001490|NCT02877407|Procedure|patient who undergo vaginal hysterectomy|
16001491|NCT02877394|Device|Squatting Assist Device|The Squatty Potty is a 7 inch tall stool to assist subjects in maintaining a squatting position while using a toilet. While sitting on the toilet, the subject supports her feet on the Squatty Potty.
16001492|NCT02877394|Device|Sham Squatting Assist Device|This stool will be 2 inches tall and be similar in appearance to the Squatty Potty. While sitting on the toilet, the subject supports her feet on the 2 inch high stool.
16001493|NCT02877381|Procedure|Revision Total Knee Arthroplasty (TKA)|Femoral component exchange, tibial component exchange, both component exchange, explant of both components and placement of antibiotic cement spacer, or a second stage re-implantation procedure. Given the variability in blood loss between types of revision TKA, randomization will be done to ensure equivalent numbers of each type of revision TKA between the treatment groups.
16001494|NCT02877381|Procedure|Revision Total Hip Arthroplasty (THA)|Femoral component exchange, acetabulum component exchange, both component exchange, explant of both components and placement of antibiotic cement spacer, or a second stage re-implantation procedure. Given the variability in blood loss between types of revision THA, randomization will be done to ensure equivalent numbers of each type of revision THA between the treatment groups.
16001495|NCT02877368|Other|Computed tomography|
16001496|NCT02877355|Drug|semaglutide|All subjects will receive 3 mg oral semaglutide for five days followed by 7 mg oral semaglutide for five days
16001497|NCT02877342|Other|Pre-hospital notification|Pre-hospital notification smartphone/tablet application in the form of an Android program that will be used by ambulance clinicians to notify emergency departments of selected hospitals of an impending arrival of a patient.
16001498|NCT02877329|Behavioral|Internet-delivered ACT|Therapist-guided Internet-delivered ACT (acceptance and commitment therapy) for 8 weeks
16001499|NCT02877316|Other|MYPLAN-safety plan as an application for smart phones|MYPLAN app as a integral part of the standard treatment
16001500|NCT02877316|Other|safety plan on paper|Standard treatment with safety plan on paper
16001501|NCT02877303|Biological|Blinatumomab|Given IV
16001502|NCT02877303|Drug|Cyclophosphamide|Given IV
16001503|NCT02877303|Drug|Cytarabine|Given IT and IV
16001504|NCT02877303|Drug|Dexamethasone|Given PO
16001505|NCT02877303|Drug|Doxorubicin Hydrochloride|Given IV
16001506|NCT02877303|Biological|Inotuzumab Ozogamicin|Given IV
16001507|NCT02877303|Other|Laboratory Biomarker Analysis|Correlative studies
16001508|NCT02877303|Drug|Mercaptopurine|Given PO
16001509|NCT02877303|Drug|Methotrexate|Given IT, IV, and PO
16001510|NCT02877303|Biological|Ofatumumab|Given IV
16001511|NCT02877303|Drug|Prednisone|Given PO
16001512|NCT02877303|Biological|Rituximab|Given IV
16001513|NCT02877303|Drug|Vincristine Sulfate|Given IV
16001514|NCT02877290|Device|non-invasive ventilation (NIV)|
16001515|NCT02877277|Dietary Supplement|Vitamin C|Oral intake of vitamin C tablet (500 mg) daily for 56 days
16001516|NCT02877277|Dietary Supplement|Placebo|Oral intake of placebo tablet daily for 56 days
16001517|NCT02877264|Drug|vapendavir 132 mg capsule|
16001518|NCT02877264|Drug|vapendavir 264 mg tablet|
16001519|NCT02877264|Drug|vapendavir 24 mg/mL oral suspension|
16001520|NCT02877238|Drug|Sevoflurane plus remote ischemic preconditioning|Inhalational anesthesia (Sevoflurane) in addition to remote ischemic preconditioning
16001521|NCT02877238|Drug|Total intravenous anesthesia plus remote ischemic preconditioning|Total intravenous anesthesia (propofol plus fentanyl) in addition to remote ischemic preconditioning
16001522|NCT02877225|Drug|Ibrutinib|Ibrutinib (test treatment) 140 milligram (mg), tablet.
16001523|NCT02877225|Drug|IMBRUVICA|IMBRUVICA (reference treatment), 140-mg capsule
16001524|NCT02877212|Drug|Eltrombopag|Eltrombopag will be given to steroid refractory ITP patients and ITP patients treated with standard Immunosuppressive therapy (IST) will be taken as control.
16001525|NCT02877199|Other|Triple therapy|Cohort of patients who received triple therapy combining pegylated-interferon/ribavirin + first generation protease inhibitor boceprevir or telaprevir as part of routine clinical practice
16001526|NCT02877186|Other|commercially-available diet soda|Subjects are asked to consume diet soda three times daily for one week.
16001527|NCT02877186|Other|carbonated water (control)|Subjects are asked to consume carbonated water three times daily for one week.
16001528|NCT02877173|Drug|Alprostadil Liposomes for Injection|3 doses of Alprostadil Liposomes for Injection are 20ug/q.d,40ug/q.d,60ug/q.d.All groups will be continuous administration for 3 weeks.
16001529|NCT02877173|Drug|Alprostadil Injection|Alprostadil Injection(the positive control group):10ug/q.d,continuous administration for 3 weeks.
16001530|NCT02877160|Drug|AL-794 suspension|
16001531|NCT02877160|Drug|AL-794 tablet|
16002384|NCT02870907|Other|Observation|no post operative chemotherapy
16001532|NCT02877147|Other|SEBTC|SEBTC benefits were issued on EBT cards using either the existing EBT delivery systems for the Supplemental Nutrition Assistance Program (SNAP) or Supplemental Nutrition Assistance Program for Women Infants and Children (WIC). Sites selected only one of the two EBT systems to be used to implement SEBTC prior to random assignment; households were not randomized to a specific delivery system.
16001536|NCT02877095|Drug|Furosemide|subcutaneous furosemide delivered via subcutaneous pump
16001537|NCT02877082|Biological|Thymoglobulin|Given IV
16001538|NCT02877082|Drug|Bortezomib|Given IV
16001539|NCT02877082|Drug|Tacrolimus|Given IV and PO
16001540|NCT02877069|Device|VYC-12 HA injectable gel|VYC-12 Hyaluronic Acid (HA) injectable gel administered as an intradermal injection.
16001541|NCT02877056|Procedure|Endoscopy|Tissue samples taken from tumor and normal colorectal tissue during standard endoscopy before therapy.
16001542|NCT02877043|Procedure|resection pulmonaire|
16001543|NCT02877030|Other|Video game|The protocol sensorimotor exercises consist of a virtual game that attaches to the Nintendo Wii and using arrows that are thrown from above, players must perform weight-shifting movements in the Nintendo platform to the target be directed to the trajectory the arrows. The goal is to catch as many arrows.
16001544|NCT02877017|Behavioral|Family safety reporting intervention|family safety reporting intervention for families and providers
16001545|NCT02877004|Device|3 Low-Level Laser Therapy Treatments Weekly|Receives 12 LLLT treatment - at a frequency of 3 times per week for 4 weeks
16001546|NCT02877004|Device|2 Low-Level Laser Therapy Treatments Weekly|Receives 12 LLLT treatments - at a frequency of 2 times per week for 6 weeks
16001547|NCT02877004|Device|1 Low-Level Laser Therapy Treatment Weekly|Receive 12 LLLT treatments - at a frequency of once per week for 12 weeks
16001548|NCT02876991|Procedure|Sodium fluoride PET|"Sodium fluoride Pet is realized maximum after 4 weeks from choline PET (inclusion).
~Injection of 4MBq 18F-FNa/kg of body weight is followed after 60 min (± 5 min) by acquisition of images on Biograph 6 PET/CT scanner (SIEMENS).
~Data from sodium fluoride PET are interpreted independently and blind from other data by 3 medical doctors (2 at hospital of Nancy and 1 at hospital of Strasbourg) (for inter-judge reproducibility); a second interpretation of data is consensually realized by 2 of 3 readers, limited to discordant analyses (metastatic status or not, and/or number of lesions); results from this second interpretation are final results."
16001549|NCT02876978|Genetic|CAR-GPC3 T Cells|Intravenous infusion of CAR-GPC3 T cells is conducted 1 - 2 days following lymphodepletion.
16001550|NCT02876978|Drug|Fludarabine|30 mg/m^2/day x 4 days
16001551|NCT02876978|Drug|Cyclophosphamide|500 mg/m^2/day x 2 days
16001552|NCT02876965|Procedure|Muscle Stretching|Subjects completed one stretching session on the main muscle groups of the body weekly.
16001553|NCT02876965|Procedure|Physical Exercise|Subjects completed 3 moderate intensity aerobic physical exercise sessions weekly.
16001554|NCT02876952|Other|HIGH VOLUME (HV) Supervised exercise|"Supervised exercise two nonconsecutive days per week (day 1-on the treadmill, day 2-on the bike) for 16 weeks. High-intensity interval training (HIIT) protocol on the treadmill: 5-min warm-up at a moderate-intensity, before walking 2 intervals of 4 min at high-intensity interspersed with intervals of 3 min of walking at moderate-intensity. 1-4 min cool-down at moderate-intensity.
~HIIT protocol on the bike: 5 to 10-min warm-up at moderate intensity. After that, 4 repetitions (1rep = 30 s high-intensity followed by 60 s moderate-intensity) and gradually increased to 16 repetitions in HV-HIIT week by week. 5-10 min cool-down at moderate-intensity"
16001555|NCT02876952|Other|Mediterranean Diet Recommendations|"Participants will be interviewed regarding their usual eating habits. They will receive practical information about which are the Mediterranean Diet (DMed) foods according to the model proposed in the PREDIMED trial. Medical doctors or nurses will give this information.
~Before starting the program of intervention, participants will assist to an informative talk in which benefits for the health of the DMed will be exposed and general information about food composition, frequencies of consumption, etc. will be explained.
~Nutritional management: Diet reviews and body mass control will be performed every two weeks to assess the body composition and adherence to treatment. In the event of poor compliance strategies will be addressed for its correction."
16001556|NCT02876952|Other|Physical Activity Recommendations|Participants will be advised to perform, without supervision, moderate to high-intensity dynamic aerobic exercise (walking, jogging, cycling or swimming) 3-5 days per week, following an adequate warm-up of 5-15 min, at moderate to high intensity (below the ischemic threshold) for a period of 20 to 40 min (not including warm-up and cool-down) followed by a cool-down period of 5-10min. Participants will receive information related to heart rate values regarding moderate and high exercise intensity domains for the self monitoring of exercise intensity.
16001557|NCT02876952|Other|LOW VOLUME (LW) Supervised exercise|Supervised exercise two nonconsecutive days per week (one day on the treadmill, and the second one on the bike) for 16 weeks. HIIT protocol on the treadmill: 5-min warm-up at a moderate-intensity, before walking 2 intervals of 4 min at high-intensity interspersed with intervals of 3 min of walking at moderate-intensity. The training session will end with a 1-4 min cool-down period at moderate-intensity. Total exercise time of 20min HIIT protocol on the bike: 10-min warm-up at moderate intensity. After that, participants will cycle for 4 repetitions (1rep = 30 s high-intensity followed by 60 s moderate-intensity) and gradually increased to 8 repetitions in LV-HIIT week by week. The training session will end with a 5-10 min cool-down period at moderate-intensity.
16001558|NCT02876939|Other|kinesiology tape around the hip, knee and ankle joints|We will also demonstrate that taping the skin increases the central representation of cutaneous afferent input in HSAN III.
16001559|NCT02876939|Other|No kinesiology tape around the hip, knee and ankle joints|Investigators will demonstrate that taping the skin increases the central representation of cutaneous afferent input in HSAN III.
16001560|NCT02876926|Behavioral|"Smart home-based test for HIV"|A standard home-based HIV test kit, fit with a Bluetooth low energy beacon to allow remote monitoring.
16001561|NCT02876926|Behavioral|Home-based testing only|A standard home-based HIV test kit.
16001562|NCT02876926|Behavioral|Reminder letters for clinic-based testing|Letters reminding patients to get tested at a free clinic location
16001563|NCT02876900|Drug|Low Dose Asenapine maleate transdermal patch|The study will evaluate low dose Asenapine maleate transdermal patch
16001564|NCT02876900|Drug|High Dose Asenapine maleate transdermal patch|The study will evaluate high dose Asenapine maleate transdermal patch
16001565|NCT02876900|Drug|Placebo|The study will evaluate placebo transdermal patch.
16001566|NCT02876887|Drug|Cocoa|
16001567|NCT02876887|Drug|Placebo|
16001568|NCT02876874|Drug|indocyanine green(ICG)|ICG will be injected into the dorsal of hand/foot
16001569|NCT02876861|Procedure|Radical nephroureterectomy|Radical nephroureterectomy (RNU) with an ipsilateral bladder cuff
16001570|NCT02876861|Procedure|Distal ureterectomy|Distal ureterectomy.
16001571|NCT02876861|Drug|Neoadjuvant Chemotherapy|Gemcitabine, 1250mg/m2, d1 d8, Cisplatin, 75mg/m2, d1-d3, 21d, 2-4 cycles.
16001572|NCT02876848|Other|OPTIMUM e-health tool|"If you are treated in a hospital that is using the OPTIMUM e-health tool (intervention group), once your care team receives any alerts, they may choose to:
~Contact you over the phone or in person to provide medical advice on how to better take your pills,
~Contact your pharmacist(s) and other doctors about your anti-cancer treatment."
16001573|NCT02876835|Drug|Daprodustat|The initial dose or oral daprodustat for ESA naïve subjects is based on Hgb and for ESA users is based on prior ESA dose. The dose is adjusted thereafter in order to achieve the target range.
16001574|NCT02876835|Drug|Darbepoetin alfa|The initial dose of darbepoetin alfa to be administered for SC injection for ESA naïve subjects is based in Hgb and weight, and for ESA users is based on converting the prior ESA dose to the nearest available study darbepoetin alfa dose. The dose is adjusted thereafter in order to achieve the target range. IV darbepoetin alfa can be considered for participants transitioning to hemodialysis.
16001575|NCT02876835|Drug|Placebo|Oral placebo tablets will be taken from Week -4 up to randomization (Day 1).
16001576|NCT02876835|Drug|Iron Therapy|Participants will receive supplemental iron therapy if ferritin is <=100 ng/mL or TSAT is <=20%. The investigator will choose the route of administration and dose of iron.
16001577|NCT02876822|Dietary Supplement|Vitamin D|
16001578|NCT02876796|Drug|GS-0976|Capsule(s) administered orally
16001579|NCT02876796|Drug|Placebo|Capsule(s) administered orally
16001580|NCT02876796|Other|1-13C acetate|10 g ± 0.25 g in 1000 mL 0.45% saline solution administered intravenously for 19 hours
16001581|NCT02876796|Other|Fructose solution|Fructose solution administered orally under fasted conditions immediately after study drug and every 30 minutes for a total of 20 doses
16001582|NCT02876783|Other|Observational - No intervention|
16001583|NCT02876770|Dietary Supplement|Experimental: Melatonin|Our protocol was composed of three experimental sessions. During each testing session, participants were requested to attend the laboratory at 20:00h where they ingested a standardized light meal. Melatonin (5 mg or 8 mg) or placebo were ingested in capsule in the evening at 21:00h in a double-blind randomized design
16001584|NCT02876770|Dietary Supplement|Placebo|In a double-blind randomized design, participants have taken placebo supplementation in one of the three experimental sessions
16001585|NCT02876757|Drug|5ARI|Exposure to finasteride/dutasteride
16001586|NCT02876744|Other|ophthalmologic examination|ophthalmologic examination including optical coherent tomography with angiography module
16001587|NCT02876731|Device|PET-CT|NaF PET-CT
16001588|NCT02876731|Device|MRI|DWMRI
16001589|NCT02876718|Drug|Rivaroxaban (Xarelto, BAY 59-7939)|No specified dosing or dosage in the study. The treatment decision falls within current practice and the prescription of the medicines is clearly separated from the decision to include the patient in the study.
16001590|NCT02876705|Other|Exercise|Completion of this study will took a total of three sessions, separated by one-week intervals. At week one, participants will complete a baseline incremental cycling and running tests to determine the workload and velocity values corresponding to their RPE (6-20 Borg's scale) = 15 (i.e., heavy). Participants also will be familiarized with the use of body maps and reporting procedures. At week two and three, participants will complete the constant-power cycling and constant velocity running tasks. The constant-power cycling and running will last up to volitional exhaustion. The end will be set when participants won't be able to cycle longer at the fixed cadence.
16001591|NCT02876692|Device|Machine perfusion|Deceased donor kidneys were preserved by hypothermic machine perfusion
16001592|NCT02876679|Drug|Cyclophosphamide|GVHD prophylaxis: All patients will receive post-transplant 50mg/Kg/day cyclophosphamide (day +3 and +4) AND cyclosporine-A alone in case of an HLA-sibling donor, or cyclosporine-A and mycophenolate-mofetil in case of an HLA-matched unrelated donor
16001593|NCT02876679|Drug|Anti-Thymocyte Globulin|GVHD prophylaxis: 2.5 mg/Kg/day ATG (Thymoglobuline®) for 2 consecutive days (day -2 and -1) All patients will receive cyclosporine-A alone in case of an HLA-sibling donor, or cyclosporine-A and mycophenolate-mofetil (MMF) in case of an HLA-matched unrelated donor.
16001594|NCT02876679|Drug|Conditioning regimen|30 mg/m2/day fludarabine for 5 days (day-6 to day-2) 130 mg/m2/day IV busulfan once daily for 2 days (day -4 and -3)
16001595|NCT02876666|Behavioral|SCI Virtual Coach|Participants are given a computer with the SCI Virtual Coach program and are asked to interact with the Coach daily for 2 months.
16001596|NCT02876653|Other|Polysomnography , blood collection, bone densitometry and Functional respiratory explorations|"Blood collection, Bone densitometry and Functional respiratory explorations are a specific interventions of protocol for the 3 arms. Polysomnography is a specific intervention for the arms  healthy volunteers "
16001597|NCT02876640|Drug|Retinoid 9cUAB30|Given PO
16001598|NCT02876640|Procedure|Therapeutic Conventional Surgery|Undergo tumor resection surgery
16001599|NCT02876627|Behavioral|Exercise training|twelve-week aerobic exercise training program consisted of three sessions per week, each session lasting 30 to 60 minutes 50 to 75 percent of their maximum heart rate reserve
16001600|NCT02876601|Drug|Defibrotide|6.25mg/kg bodyweight over 2h infusion
16001601|NCT02876601|Drug|Placebo (0.9% sodium chloride)|(0.9% sodium chloride) infusion over 2h infusion
16001602|NCT02876601|Drug|Lipopolysaccharide|bolus infusion of 2ng/kg bodyweight lps
16001603|NCT02876601|Drug|Placebo (0.9% sodium chloride bolus)|(0.9% sodium chloride) bolus infusion
16001604|NCT02876588|Other|Unrestricted|Users may open up to 4 patient records at a time.
16001605|NCT02876588|Other|Restricted|Users are restricted to open 1 patient record at a time.
16001606|NCT02876575|Device|A bipolar instrument for tonsillectomies|A bipolar electrosurgical device that employs RF energy and pressure to ligate vessels interposed between its jaws which can then be transected using the built in knife deployed by the device trigger.
16001607|NCT02876562|Procedure|root coverage with collagen matrix|the material used is a porcine derived native collagen matrix which serves an alternative to connective tissue graft. the material is 1.5 mm in thickness with a specific tissue surface to allow for cell migration and a fibrous outer layer. it has a resorption time of 6 months.
16001608|NCT02876549|Drug|Chloroquine|10 mg/kg on day 0 & 1 and 5mg/kg on day 2, (Afghanistan NMLCP guidelines)
16001609|NCT02876549|Drug|Primaquine 0.25 mg/kg/day|0.25 mg/kg/day for 14 days
16001610|NCT02876549|Drug|Primaquine 0.75 mg/kg weekly|0.75 mg/kg weekly for eight weeks
16001611|NCT02876536|Device|TENS|The effect of TENS device will be compared in case and control groups.
16001612|NCT02876510|Drug|Fludarabine|Fludarabine infusion
16001613|NCT02876510|Drug|Cyclophosphamide|Cyclophosphamide infusion
16001614|NCT02876510|Biological|IMA101 product|i.v. infusion of IMA101 product(s).
16001615|NCT02876510|Biological|Recombinant human interleukin-2|Low dose IL-2 Infusion for two weeks
16001616|NCT02876510|Diagnostic Test|IMADetect|IMADetect is a laboratory test that is part of screening used to determine the mRNA expression of ACTolog target source genes in tumor biopsies from solid tumors. IMADetect is intended for investigational use only.
16001617|NCT02876510|Drug|Atezolizumab|Atezolizumab infusion will be given no earlier than 3 weeks post IMA101 infusion and after hematologic recovery is achieved, thereafter every 3 weeks until 1 year after IMA101 infusion.
16001618|NCT02876497|Other|Define macrophages migration mode|Archival tumor samples analysis and blood sample testing
16001619|NCT02876484|Drug|Colesevelam|
16001620|NCT02876484|Drug|Chenodeoxycholic Acid|
16001621|NCT02876484|Other|Water|
16001622|NCT02876471|Other|CPAP|OSA complicated with hypertension：In order to avoid the effects of drugs on this study, we calculated the time to stop based on the half-life of patients taking oral drugs and last time administration time. The subject who withdrawal time was less than three days was enrolled in our study. These patients were hospitalized and close monitoring of blood pressure, for blood pressure three times greater than 180/110mmHg or appearing dizziness, headache and other clinical syndrome, we give a timely clinical intervention and get rid of our study. Screening of 40 newly diagnosed patients with hypertension and subjects with poor blood control,the investigators would give one-night CPAP
16001623|NCT02876458|Other|Immediate coronary angiogram|An immediate coronary angiogram will be performed
16001624|NCT02876458|Other|Delayed coronary angiogram|A delayed coronary angiogram (between 48 to 96 hours) will be performed
16001625|NCT02876445|Other|ZARIT Burden Interview|ZARIT Burden Interview completed Day 0 and 1 year
16001626|NCT02876432|Device|Electroacupuncture|"The acupuncture points selected were ST36, BL25, GB30, BL40, GB34 the needles were inserted into acupoints and the depth of needle insertion depended of the acupoints selected to achieve Deqi sensation, which is characterized as a numb, heavy, sore and/or distending sensation.
~Electrical stimulation was delivered at 4 Hz. The stimulator (ITO EST-160) was then switched on, and the intensity was gradually increased to reach a strong but comfortable level the sensation of EA which is characterized for numbness, tingling and a light muscle cramp. For 15 minutes"
16001627|NCT02876432|Drug|Diclofenac sodium|100 mg Diclofenac sodium was administrated orally every 12 hours for 5 days.
16001628|NCT02876432|Other|Sham electroacupuncture|The investigators use 1.0 cm outside point of the real electroacupuncture, the depth of needle insertion was superficial to avoid Deqi sensation, the cables wasn't connected to the electro stimulator and was then switched on for 15 minutes. The participants were threaded separately to avoid sharing experiences about the electroacupuncture sessions
16001629|NCT02876354|Drug|Menaquinone|Patients on hemodialysis will be supplemented by 360 μg /d of menaquinone for 4 weeks. At baseline they will have a lateral abdominal X-Ray and dosage of dp-ucMGP. At the end of the study patients will have a second measurement of dp-ucMGP levels.
16001630|NCT02876328|Biological|Ad26.ZEBOV|0.5 mL at a dose of 5x10^10 vp administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
16001631|NCT02876328|Biological|MVA-BN-Filo|0.5 mL at a dose of 1x10^8 InfU administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
16001632|NCT02876328|Biological|rVSVΔG-ZEBOV-GP|1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
16001633|NCT02876328|Biological|Placebo|0.5 mL or 1 mL (depending upon the arm) sterile normal saline administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
16001634|NCT02876328|Biological|rVSV boost|1 mL at a nominal dose of 2x10^7 pfu/mL administered by intramuscular (IM) injection into the upper arm for adults or the thigh for children
16001635|NCT02876315|Dietary Supplement|Redoxon VI|"Each tablet contains:
~Vitamin C (500mg) Vitamin A (1167IU) Vitamin B6 (3.3mg) Vitamin B12 4.8µg) Vitamin D (200IU) Vitamin E (22.5mg) Folic Acid (200µg) Zinc (5mg) Selenium (55µg) Copper (450µg) Iron (2.5mg)
~Other ingredients: Microcrystalline cellulose, magnesium stearate, hydroxypropylmethylcellulose, hydroxypropylcellulose hypromellose, titanium dioxide, microcrystalline cellulose, iron oxide yellow, sodium croscarmellose, and talc"
16001636|NCT02876315|Dietary Supplement|placebo|Ingredients: Microcrystalline cellulose, magnesium stearate, hydroxypropylmethylcellulose, hydroxypropylcellulose hypromellose, titanium dioxide, microcrystalline cellulose, iron oxide yellow, sodium croscarmellose, and talc
16001637|NCT02876302|Drug|Ruxolitinib|15 or 20 mg, twice daily by mouth. The run-in part of ruxolitinib lasts 7 days; The treatment of ruxolitinib part lasts 12 weeks.
16001638|NCT02876302|Drug|Paclitaxel|80 mg/m2, IV (in the vein) weekly for 12 weeks.
16001639|NCT02876302|Drug|Doxorubicin|60 mg/m2, IV (in the vein) every 14 days for 4 doses.
16001640|NCT02876302|Drug|Cyclophosphamide|600 mg/m2, IV (in the vein) every 14 days for 4 doses.
16001641|NCT02876289|Drug|Perampanel|
16001642|NCT02876276|Procedure|Hyaluronic acid filler|Papillary augmentation with HA dermal fillers was considered as the test group
16001643|NCT02876250|Drug|Cyclosporine A|a pharmacological postconditioned group with IV administration of 2.5 mg/kg of CsA prior to first graft reperfusion
16002512|NCT02870036|Drug|5-fluorouracil and Leucovorin Calcium|
16001644|NCT02876250|Drug|Placebo|a control group with IV administration of 2.5 mg/kg of placebo prior to first graft reperfusion
16001645|NCT02876237|Other|geriatric assessment and quality of life|"Included patient must have a geriatric assessment before radiotherapy and 6 months later. This standardized geriatric assessment will collect social information, functional, sensory, cognitive, emotional, motor, nutritional, and medical related to comorbidities .
~Patient must complete quality of life questionnaire before radiotherapy then 2 and 6 months later."
16001646|NCT02876237|Radiation|Radiotherapy|standard radiotherapy
16001647|NCT02876224|Drug|Atezolizumab|Atezolizumab 840 mg will be administered by IV infusion on Days 1 and 15 of each 28-day cycle.
16001648|NCT02876224|Drug|Bevacizumab|Bevacizumab 5 mg/kg will be administered by IV infusion on Days 1 and 15 of each 28-day cycle.
16001649|NCT02876224|Drug|Cobimetinib|Cobimetinib 60 mg or at dose determined during safety run-in phase will be administered orally once daily for 21 days of each 28-day cycle as specified in the arm descriptions.
16001650|NCT02876211|Drug|Paricalcitol|Paricalcitol 2 capsules/three times per week
16001651|NCT02876211|Drug|Epoetin beta|epoetin 1-3 times per week
16001652|NCT02876211|Drug|Placebo|Placebo 2 capsules/three times per week
16001653|NCT02876198|Device|Gonioscopy|Study of the trabecular structure by gonioscopy
16001654|NCT02876185|Other|Monitoring by an orthoptist then by an ophthalmologist|At each visit, the usual monitoring tests will be collected and viewed by the orthoptist then by the ophthalmologist concerning the necessity of an anticipated ophthalmological consultation
16001655|NCT02876172|Drug|MDMA|Two sessions of MDMA-assisted therapy, one with an initial dose of 75 mg (and optional supplemental dose of 37.5 mg) and the second with 75 or 100 mg MDMA (with optional supplemental dose of either 37.5 mg or 50 mg respectively) given to the participant with PTSD and their significant other.
16001656|NCT02876172|Behavioral|CBCT|A three-phase, 15-session, manualized treatment from the CBCT manual
16001657|NCT02876172|Behavioral|Therapy|Non-directive therapy (from the Multidisciplinary Association for Psychedelic Studies MDMA-assisted therapy treatment manual)
16001658|NCT02876159|Biological|2016-2017 Influenza Vaccine|Quadrivalent influenza A/Hemagglutinin Type 1 (H1N1), A/Influenza A virus subtype (A/H3N2) H3N2,and B virus vaccine for Intramuscular (IM) use is a sterile, clear and slightly opalescent suspension administered as a single 0.5 mL intramuscular dose.
16001659|NCT02876146|Drug|Benzimidazole|Withdrawal of benzimidazole after 4 years (non operable AE) or one year after surgery (curative hepatectomy)
16001660|NCT02876133|Device|narrow band imaging withdrawal|colonoscope withdrawal and mucosal inspection performed under narrow band imaging
16001661|NCT02876133|Device|white light withdrawal|colonoscope withdrawal and mucosal inspection performed under white light imaging
16001662|NCT02876120|Other|Implementation|Multifaceted implementation strategy to implement evidence based international osteoarthritis treatment recommendations among GPs and PTs in private practice, template for PT discharge reports to GP, patient osteoarthritis education programs, and facilitate multidisciplinary collaboration between the PTs and GPs.
16001663|NCT02876107|Drug|Carboplatin|Given IV
16001664|NCT02876107|Other|Laboratory Biomarker Analysis|Correlative studies
16001665|NCT02876107|Drug|Paclitaxel|Given IV
16001666|NCT02876107|Biological|Panitumumab|Given IV
16001667|NCT02876094|Drug|celecoxib|dose-response
16001668|NCT02876081|Drug|Afatinib|to evaluate the efficacy of afatinib, an EGFR TKI, on lung adenocarcinomas, EGFR wild-type, bearing the NTS/NTSR1 complex with a high level of expression
16001669|NCT02876055|Drug|Single shot interscalene nerve block|Peripheral regional anesthesia nerve block - Single shot interscalene nerve block
16001670|NCT02876055|Drug|Continuous interscalene nerve block|Peripheral regional anesthesia nerve block - continuous catheter interscalene nerve block
16001671|NCT02876055|Drug|Local Infiltration Analgesia (LIA)|Injection of local anesthetic into the peri-articular tissues and intra-articular capsule in a systematic approach for orthopedic surgery
16001672|NCT02876042|Device|BAROSTIM NEO™ System|Implantation of the BAROSTIM NEO™ System
16001673|NCT02876029|Other|Reference|the reference product used
16001674|NCT02876029|Other|Test product|The test Product used
16001675|NCT02876016|Device|functional MRI|locate the cerebral bases in functional imaging
16001676|NCT02876003|Drug|G-202|G-202 administered by intravenous infusion (IV, in the vein) on Days 1, 2 and 3 of each 28-day cycle until progression or development of unacceptable toxicity
16001677|NCT02875990|Biological|Blood sample|
16001678|NCT02875977|Other|Educational video|A 4-minute educational video describing PFPT
16001679|NCT02875977|Other|Educational handout|A 2-page educational handout describing PFPT
16001680|NCT02875964|Device|electroencephalogram|Implanting electrode to measure brain activity
16001681|NCT02875964|Device|magnetoencephalogram|Implanting electrode to measure brain activity
16001682|NCT02875938|Behavioral|Simultaneous music and reading lyrics|music with sung lyrics simultaneously with silent reading of the lyrics.
16001683|NCT02875938|Behavioral|Priming with music|priming with music and sung lyrics followed by reading of the lyrics.
16001684|NCT02875938|Behavioral|Control|control condition using reading materials without music.
16001685|NCT02875925|Other|MTM|Medication management is a process that ensures each patient's medications are assessed to determine the appropriateness, effectiveness, safety, and convenience of each medication for the patient. Medication management is fully integrated with the care team. Pharmacists provide this service to identify, prevent, and resolve drug therapy problems improve outcomes.
16001686|NCT02875912|Behavioral|Family Care Rituals|"Family members being enrolled are given a pamphlet outlining the Family Care Rituals. They are informed of the opportunity to perform these rituals, but that they are in no way obligated to do so.
~Family members are then surveyed at enrollment, and 90 days post ICU discharge for symptoms of PTSD, as well as depression, and anxiety.
~Family members, day-time nursing, and attending physicians are surveyed for concordance of care at enrollment and ICU day 5.
~Demographic information is also collected on the patient and the family members at enrollment Nursing completes surveys while the patient is in the ICU noting what care rituals, if any, are being performed. Additionally, they are asked to complete a survey indicating their opinion of the impact on the care they deliver"
16001687|NCT02875886|Drug|Amiloride|Combined with hydrochlorothiazide
16001690|NCT02875873|Drug|Plasma-Lyte|Plasma-Lyte will be used for fluid expansion and maintenance
16001691|NCT02875873|Drug|Saline 0.9%|Saline 0.9% will be used for fluid expansion and maintenance
16001692|NCT02875873|Other|Slow infusion speed|Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 333 mL/h. NOTE: This intervention will not be blinded.
16001693|NCT02875873|Other|Fast Infusion Speed|Whenever fluid expansion is deemed necessary by the attending physician, infusion speed will be set at 999 mL/h. NOTE: This intervention will not be blinded.
16001694|NCT02875860|Device|GoldBal2 detachable balloon|Placement of the balloon using the plug/unplug method.
16001695|NCT02875860|Device|Baltaccidbpe100 Delivery Catheter|The catheter assists with implanting the balloon in the plug/unplug method.
16001696|NCT02875860|Other|Standardized postnatal care|After birth, the babies will receive standardized postnatal care at a tertiary center used to manage babies with CDH. The recommendation is that they adhere to consensus guidelines published on the study website. For detailed description on this please visit https://www.karger.com/Article/Abstract/320622
16001697|NCT02875847|Dietary Supplement|HMO1|
16001698|NCT02875847|Dietary Supplement|HMO2|
16001699|NCT02875847|Dietary Supplement|Dextropur|
16001700|NCT02875834|Drug|Sodium Zirconium Cyclosilicate (ZS) 10g|Suspension administered 10g orally three times per day, in the first 48-hour of the study for all patients (48-hour open label initial phase)
16001701|NCT02875834|Drug|Sodium Zirconium Cyclosilicate (ZS) 5g|Suspension administered 5g orally once daily for 28 days after the first 48-hour open label initial phase.
16001702|NCT02875834|Drug|Sodium Zirconium Cyclosilicate (ZS) 10g|Suspension administered 10g orally once daily for 28 days after the first 48-hour open label initial phase.
16001703|NCT02875834|Drug|Placebo|Suspension administered orally placebo once daily for 28 days after the first 48-hour open label initial phase.
16001704|NCT02875821|Drug|Ipragliflozin|Patients treated with ipragliflozin (50 mg/day) as add on therapy to metformin and pioglitazone dual therapy (triple therapy) for 6 months. During whole periods of study, subjects are educated for nutrition and exercise. (Experimental Group)
16001705|NCT02875821|Drug|metformin with pioglitazone|Patients maintain metformin and pioglitazone dual therapy for 6 months. During whole periods of study, subjects are educated for nutrition and exercise. (Control group)
16001706|NCT02875795|Procedure|automatic speech processing tool|
16001707|NCT02875782|Behavioral|Smoking cessation and DM specific component intervention|A brief stage-matched smoking cessation intervention plus a DM-specific leaflet on smoking cessation
16001708|NCT02875782|Behavioral|Control group|A simple, brief advice and a self-help general leaflet on smoking cessation
16001709|NCT02875769|Procedure|Dental prophylaxis|Full mouth dental prophylaxis (FMDP) was conducted in one appointment lasting 10 minute, using an ultrasonic scaler at a frequency of 25 kHz (Cavitron Select SPC, Dentsply professional, York, PA, USA) at less than 50% power. The FMDP performed without anesthesia and in order to eliminate supragingival plaque, calculus and stainings.
16001710|NCT02875769|Drug|Mouthwash CPC+Zn+F|The volunteer rinsed with pre-procedural mouthwash containing 0.075% cetylpyridinium chloride, 0.28% zinc lactate and 0.05% sodium fluoride in an Alcohol-free base for one minute, 20 ml of solution and then expectorated all remaining liquid.
16001711|NCT02875769|Drug|Mouthwash CHX|The volunteer rinsed with pre-procedural mouthwash containing 0.12% CHX with 10% alcohol for one minute, 20 ml of solution and then expectorated all remaining liquid.
16001712|NCT02875769|Other|No rinsing|The volunteer did not rinse with any pre-procedural mothwash.
16001713|NCT02875769|Other|Water|The volunteer rinsed with pre-procedural mouthwash containing water from a three-way syringe for one minute, 20 ml of water and then expectorated all remaining liquid.
16001714|NCT02875756|Procedure|10 revolutions|The 22G needle (Vizishot, Olympus) will be used to obtain specimens from the enlarged lymph nodes during EBUS. Once inside the lymph node, needle will be passed to and fro 10 times
16001715|NCT02875756|Procedure|20 revolutions|The 22G needle (Vizishot, Olympus) will be used to obtain specimens from the enlarged lymph nodes during EBUS. Once inside the lymph node, needle will be passed to and fro 20 times
16001716|NCT02875743|Drug|Posaconazole|
16001717|NCT02875730|Procedure|Pulse Sequence|Cylindrical Navigator Preparatory Pulse Sequence
16001718|NCT02875730|Procedure|CMRI|Cardiac Magnetic Resonance Imaging
16001719|NCT02875717|Drug|Acetylsalicylic acid|
16001720|NCT02875717|Drug|low molecular weight heparin|
16001721|NCT02875704|Other|Anterior Chamber (AC) Tap|Aqueous Samples will be collected for measurement of biomarkers
16001722|NCT02875691|Dietary Supplement|green tea extract|Patients are given daily dose of 1000mg aqueous green tea extract (of 6 grams of dried green tea leaf) in the form of 2 capsules( 500 mg) for three months.
16001723|NCT02875691|Dietary Supplement|placebo|Patients in placebo group receive daily dose of 1000 mg cellulose in the form of 2 capsules (500 mg) for three months
16001724|NCT02875678|Drug|ABX-1431|Single-dose ABX-1431
16001725|NCT02875678|Drug|Placebo|Single-dose matching placebo
16001726|NCT02875665|Device|geko(TM) device|The geko(TM) device will be used to electrically stimulate the posterior tibial nerve
16001727|NCT02875652|Biological|Blood sampling|3 vials of 7,5 ml of peripherical blood will be collected at each blood sample.
16001728|NCT02875639|Drug|Yiqi prescription|
16001729|NCT02875639|Drug|Huoxue prescription|
16001730|NCT02875639|Drug|Buyang huanwu decoction|
16001731|NCT02875639|Drug|QISHEN YIQI DRIPPING PILLS|
16001732|NCT02875639|Drug|Placebo 1|Placebo 1：a drug which imitated QISHEN YIQI DRIPPING PILLS,but do not have active ingredient,just have the excipient.
16001733|NCT02875639|Drug|Placebo 2|Placebo 2：a drug which imitated Buyang huanwu decoction,but do not have active ingredient,just have the excipient.
16001734|NCT02875626|Drug|Infracyanine|In the beginning of the intervention, a periareolar injection of the Infracyanine will be carried out (Infracyanine®, 2ml to 2.5mg/ml whether 3.2nM).
16001735|NCT02875613|Drug|Avelumab|Avelumab 10mg/kg IV on days 1 and 15 of each 28-day cycle. Treatment will be given until disease progression, unacceptable toxicity, investigator decision or patient withdrawal.
16001842|NCT02874794|Drug|Placebo of Enalapril|matching placebo (2.5mg, 5mg and 10mg) oral, tablets
16002513|NCT02870036|Drug|Thalidomide|
16001736|NCT02875600|Other|Nutri Drink|To determine the difference in baseline MR flow measurements and post prandial MR flow measurements between patients diagnosed with CGI and patients not diagnosed with CGI
16001737|NCT02875587|Drug|Cabergoline|Cabergoline (Dostinex; Pfizer, Italy) at a daily dose of 0.5 mg is administered orally at bed time for 8 days starting on the day of HCG administration
16001738|NCT02875587|Drug|Calcium gluconate|Intravenous 10% calcium gluconate, 10 mL in 200 mL of physiologic saline on the day of ovum pickup, day 1, day 2, and day 3 after ovum pickup. Intravenous infusion will be performed within 30 minutes.
16001739|NCT02875574|Drug|Any treatment regimen|Treatment regimen used to treat patient once isoniazid resistance known (exposure of interest for cohort study)
16001740|NCT02875574|Other|Bacterial mutation|Resistance, compensatory or other mutation in the infecting strain of Mycobacterium tuberculosis (exposure of interest for nested case-control study)
16001741|NCT02875561|Device|Sonopet Ultrasonic Aspirator|To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation
16001742|NCT02875561|Device|CO2 Laser Ablation|To evaluate the incident of recurrence of VIN dysplasia events in women treated for VIN with the sonopet ultrasonic aspirator compared to CO2 Laser Ablation
16001743|NCT02875548|Drug|Tazemetostat|Tazemetostat (EPZ-6438) is a selective small molecule inhibitor of the histone-lysine methyltransferase EZH2 gene.
16001744|NCT02875535|Behavioral|RLAS|"The implementation model for this intervention will increase school-based supports and safety for gender and sexual minorities and broader student bodies, and be applicable to addressing other priority child and adolescent health and mental health issues within schools. The investigators refer to the model as RLAS (Implementing School Nursing Strategies to Reduce LGBTQ Adolescent Suicide)."
16001745|NCT02875522|Other|Individualized, non-linear aerobic exercise training|Aerobic exercise performed on lower body stationary ergometer and an upper extremity arm crank. Intensity (50-95% workload maximum) and durations (20-45 min) are fluctuated daily to optimize training stress and adaptation
16001746|NCT02875483|Other|Expedited Scheduling|Patients are scheduled for tubal ligation surgery prior to discharge from the post-partum hospital service, with target date 4-8 weeks post-partum.
16001747|NCT02875483|Other|Standard Scheduling|Scheduling of tubal surgery occurs after completion of post-partum office visit
16001748|NCT02875470|Device|Intensiv Perio Set|Diamond burs for root planing
16001749|NCT02875470|Device|Gracey curette|
16001750|NCT02875457|Drug|apatinib;etoposide and cisplatin|
16001751|NCT02875457|Drug|placebo;etoposide and cisplatin|
16001752|NCT02875444|Other|Angio-CT|
16001753|NCT02875431|Procedure|Patients undergo ACDF or cervical vertebral body replacement|
16001754|NCT02875418|Device|EUM|"STUDY DESIGN
~Explanation regarding the study and assessing eligibility criteria.
~Signing an informed consent.
~Recording of uterine contractions by both EUM and tocodynamometry. A correlation between EUM and tocodynamometry will be calculated. For the purpose of this study, a positive EUM or tocodynamometry will be defined as 3 at least 3 contractions in 30 minutes."
16001755|NCT02875418|Device|Tocodynamometry|"STUDY DESIGN
~Explanation regarding the study and assessing eligibility criteria.
~Signing an informed consent.
~Recording of uterine contractions by both EUM and tocodynamometry. A correlation between EUM and tocodynamometry will be calculated. For the purpose of this study, a positive EUM or tocodynamometry will be defined as 3 at least 3 contractions in 30 minutes."
16001756|NCT02875405|Procedure|Posterior left pericardiotomy|Patient will receive a posterior left sided pericardiotomy. The incision will be made posterior to the phrenic nerve and run from the inferior left pulmonary vein to the diaphragm.
16001757|NCT02875392|Other|275mg Oligo Fucoidan + 275mg HS Fucoxanthin|Fucoidan is a water-soluble dietary fiber which is extracted from brown seaweed. Slimy surface of brown seaweed has unique ingredients and different kind of brown seaweed has slightly different effectiveness.The subject of this study focus on assessing the impact on the metabolism of fatty liver and liver fibrosis after taking oral FucoHiQ capsules.
16001758|NCT02875392|Other|placebo pills|taking placebo pills as if patients are under treatment.
16001759|NCT02875379|Procedure|Measurements|Measurements of respiratory mechanics and parameters, arterial blood gases and comfort
16001760|NCT02875366|Drug|LUM/IVA|
16001761|NCT02875366|Drug|Placebo|
16001762|NCT02875353|Device|Doppler Endoscopic Probe|A colon length catheter (probe).
16001763|NCT02875340|Drug|VAL401|Risperidone formulated into a liquid lipid filled capsule
16001764|NCT02875314|Drug|Induction|vincristine, cisplatin, cyclophosphamide, etoposide, high-dose methotrexate
16001765|NCT02875314|Drug|Single Cycle Intensive Chemotherapy|Carboplatin, thiotepa, etoposide
16001766|NCT02875314|Drug|Tandem 3 Cycle Intensive Chemotherapy|Carboplatin, thiotepa
16001767|NCT02875301|Behavioral|150 Minutes Week|This group will walk 150 minutes per week. Participants will have 3 supervised exercise sessions per week. A walking duration of 30 minutes will be achieved by the third week of the program and be maintained for the duration of the intervention. Heart rate will be monitored to ensure proper intensity levels. Participants will also be instructed to exercise at home for 30 minutes for two other days of the week at a similar intensity. The prescribed intensity will be 50-60% of the maximum heart rate reserve for weeks one to six and 60-75% for the remainder of the program. Participants in the walking conditions will wear heart rate monitors and be encouraged to walk within their target heart rate zone. During the current Covid-19 pandemic, all intervention exercise has been shifted to home based.
16001768|NCT02875301|Behavioral|225 Minutes Week|This group will walk 225 minutes per week. Participants will have 3 supervised exercise sessions per week. A walking duration of 45 minutes will be achieved by the sixth week of the program. This will be maintained for the duration of the intervention and heart rate will be monitored to ensure proper intensity levels. Participants will be instructed to exercise at home for 45 minutes for two other days of the week at a similar intensity. The prescribed intensity will be 50-60% of the maximum heart rate reserve for weeks one to six and 60-75% for the remainder of the program. Participants in the walking conditions will wear heart rate monitors and be encouraged to walk within their target heart rate zone. During the current Covid-19 pandemic, all intervention exercise has been shifted to home based.
16001808|NCT02875015|Drug|Liposomal Bupivacaine|20 mL of Liposomal Bupivacaine (EXPAREL) will be diluted in 80 mL of injectable saline used for hydro-dissection of the vesicovaginal space and along the track of the sling trocars
16001769|NCT02875301|Behavioral|Stretch and Tone|The control condition will focus on improving balance, flexibility, and strength. This group will meet for supervised sessions 3 times per week for 12 months. Resistance bands, balance disks, yoga blocks, and exercise mats will be used to engage in non-cardiorespiratory activities. These are progressive in nature and include modifications to accommodate injuries, physical difficulties, etc. A new set of similar, yet slightly more challenging activities will be introduced every four weeks. During the first two weeks, participants are introduced to the new activities, and, during the second two weeks, they are encouraged to increase intensity by using more weight or more repetitions. During the current Covid-19 pandemic, all intervention exercise has been shifted to home based.
16001770|NCT02875288|Drug|liposomal bupivicaine|"The intervention that is being tested and who will perform the procedures; Two general surgeons will perform the procedure with either liposomal or plain bupivacaine.
~The treatment procedures or regimens; The treatment procedure is direct, surgical site infiltration with either liposomal or plain bupivacaine.
~Dosage level and justification; Liposomal Bupivacaine: 266 mg/20 mL liposomal bupivacaine diluted to 30 mL Plain Bupivacaine: 30 mL of 0.5% plain bupivacaine
~Route of drug administration; Surgical site infiltration"
16001771|NCT02875275|Other|Glucose with grass jelly solution|50 g glucose and 3.12 g grass jelly dissolve in water (top up to 200g)
16001772|NCT02875275|Other|Glucose with grass jelly (solid)|50 g glucose and 3.12 g grass jelly and 3.12g starch dissolve in hot water (top up to 200g)
16001773|NCT02875275|Other|Porridge and juice with coconut oil|Add instant porridge with hot water with oil. Consume with commercially available orange juice
16001774|NCT02875275|Other|Porridge and juice with coconut oil gel|Add instant porridge with hot water with oleogel. Consume with commercially available orange juice
16001775|NCT02875262|Drug|Deferoxamine|Patients will be given deferoxamine 32 mg/kg/day (max iv rate 15 mg/kg/hr), patients with ferritin levels between 2,000 and 3,000 ng/ml will receive 32 mg/kg/day and patients with serum ferritin levels below 2,000 ng/ml wil receive 25 mg/kg/day.during 3 days
16001776|NCT02875262|Other|placebo|placebo (NaCl 0.9%) in equal dose to treatment
16001777|NCT02875249|Other|patients stool collection|patients stool collection
16001778|NCT02875236|Drug|OctaplasLG®|"OctaplasLG is an donor plasma product pooled from approximately 1000 single donor units. It possesses unique features when compared to standard fresh frozen plasma, such as having standardized concentrations of natural pro- and anti-coagulation factors, a standardized volume as well as being pathogen free. The manufacturing method of OctaplasLG removes immune complexes and cells in several steps of microfiltration in addition to viral, bacterial and prion pathogen inactivation by immune neutralization. OctaplasLG should reduce the inflammatory hit on the endothelium, including the glycocalyx, by having standardized levels of coagulation proteins, which can give more sustainable support to the endothelial regeneration as compared to standard fresh frozen plasma."
16001779|NCT02875236|Drug|Ringer-acetat|Crystalloid used as standard of care.
16001780|NCT02875223|Drug|CC-90011|
16001781|NCT02875210|Procedure|Laximeter measurement|
16001782|NCT02875197|Other|Running on a treadmill at 6 different speeds|All subjects will be required to run at 6 prescribed speeds (2.5, 3.0, 3.5, 4.0, 5.0, and 6.0 m/sec) on a treadmill completing at least 10 consecutive strides, or running for 30 seconds.
16001783|NCT02875171|Drug|Anthracycline administration|Patients suffering from lymphoma or acute leukemia and requiring anthracycline administration were included
16001784|NCT02875158|Procedure|Cyclophotocoagulation protocol|"Intravenous route is installed
~Retrobulbar anaesthesia : 50% xylocaine (2%) + 50% bupivicaine
~Parameters set for laser treatment (1250mW-4seconds or 2000mW-2 seconds depending on the assigned group)
~Pars plana measurement using transillumination (if needed)
~Laser treatment applied approximately 1mm post to limbus
~Dexamethasone 0,5 mg subconjunctival injection
~Post-op regimen: Prednisolone 1% qid x 4 weeks, Atropine 1% bid x 2 weeks + Erythromycin ointment + patch x 6h"
16001785|NCT02875158|Procedure|Conventional cyclophotocoagulation|1250 mW for 4 seconds.
16001786|NCT02875158|Procedure|Modified cyclophotocoagulation|2000 mW for 2 seconds.
16001787|NCT02875145|Procedure|Cataract surgery|
16001788|NCT02875132|Drug|pembrolizumab|pembrolizumab at 200mg IV infusion every 3 weeks
16001789|NCT02875119|Drug|Griffithsin Gel|"Griffithsin Gel is a large biologic molecule that is intended for vaginal rather than systemic administration. In addition, Griffithsin Gel is being developed for the prevention of HIV infection and not as a therapeutic agent. The concentration of Griffithsin Gel associated with prevention of HIV in vitro and in vivo has been established in non-clinical studies (see Section 5). Studies have demonstrated that Griffithsin Gel is highly potent for HIV prevention and is effective at very low concentrations.
~One 4 mL dose of PC-6500, designed to provide an adequate vaginal concentration of GRFT for the prevention of HIV, based on preclinical data, will be evaluated. Rising dose tolerance is not the goal of this study because GRFT is likely to be minimally absorbed systemically, if at all."
16001790|NCT02875119|Drug|Placebo Gel|Placebo Gel
16001791|NCT02875106|Device|12-point-ECG|routine recording will be 300 seconds
16001792|NCT02875106|Device|Polar V800|routine recording will be 300 seconds
16001793|NCT02875106|Device|360° eMotion FAROS SET + Belt|routine recording will be 300 seconds
16001794|NCT02875106|Device|Adidas Micoach smart run|routine recording will be 300 seconds
16001795|NCT02875106|Device|TomTom Runner Cardio HRM|routine recording will be 300 seconds
16001796|NCT02875093|Drug|ADI-PEG 20|Investigational Medicine
16001797|NCT02875093|Drug|Cytarabine|low-dose cytarabine 20 mg BID twice daily for 10 days, every 28 days
16001798|NCT02875080|Drug|OPC-34712|
16001799|NCT02875067|Biological|Pembrolizumab|
16001800|NCT02875067|Drug|Lenalidomide|
16001801|NCT02875054|Behavioral|Constraint induced movement therapy (CIMT)|Involves forcing use of ones affected upper extremity (UE) by physically restraining the less affected upper extremity
16001802|NCT02875054|Behavioral|Hand-arm bimanual intensive training (HABIT)|Facilitates the translation of gains to improve goal-directed bimanual performance.
16001803|NCT02875041|Device|Transcranial Magnetic Stimulation (TMS)|
16001804|NCT02875041|Device|MAGSTIM Rapid2|
16001805|NCT02875028|Drug|Vorapaxar|10mg-20mg vorapaxar to achieve >80% thrombin-receptor activated peptide-6 (TRAP) induced platelet inhibition
16001806|NCT02875028|Drug|Placebo|
16001807|NCT02875028|Other|LPS|2ng/kg Lipopolysaccharide as a bolus infusion
16001809|NCT02875015|Drug|Bupivacaine Hydrochloride and Lidocaine|Bupivacaine Hydrochloride (HCL) and Lidocaine. Fifty mL of 0.05% Marcaine and 30 mL of Lidocaine will be diluted in 100 mL of injectable saline used for hydro-dissection of the vesicovaginal space and along the track of the sling trocars during the placement of a suburethral sling.
16001810|NCT02875015|Procedure|Suburethral Sling|A retropubic, transobturator or mini-sling will be placed in the usual fashion followed by diagnostic cystoscopy.
16001811|NCT02875002|Drug|volasertib|Volasertib (BI6727) is a small molecule inhibitor of the polo-like kinase 1 (PLK1) protein. Infusion for 60 minutes. Dosing will start at 25 mg/m^2, is schedule to increase to 100mg/m^2, and be administered on days 1 and 8 of each 28-day cycle.
16001812|NCT02875002|Drug|belinostat|Belinostat is a histone deacetylase inhibitor. Infusion will take 30 minutes. Dosing will start at 600 mg/m^2 , is scheduled to increase to 1000 mg/m^2, and will be administered on days 1,2,3 and 8,9,10 of each 28-day cycle.
16001813|NCT02874989|Drug|Dasatinib + Quercetin|
16001814|NCT02874989|Drug|Placebo|
16001815|NCT02874976|Device|Active and Active Phototherapy|Participants performed a aerobic training. Ninety-six subjects practice a regular aerobic exercise program on a treadmill was applied 3 times a week for 12 weeks,each session lasting 30 minutes, ranging between 70-80 % of maximum heart rate intensity and the evaluations are done monthly through a maximum progressive exercise protocol. Phototherapy, active or placebo, were applied in 9 different points of quadriceps,6 points in the posterior thigh and two points in the gastrocnemius muscle, depending the group randomized, before and after each training session.
16001816|NCT02874976|Device|Active and Placebo Phototherapy|Participants performed a aerobic training. Ninety-six subjects practice a regular aerobic exercise program on a treadmill was applied 3 times a week for 12 weeks,each session lasting 30 minutes, ranging between 70-80 % of maximum heart rate intensity and the evaluations are done monthly through a maximum progressive exercise protocol. Phototherapy, active or placebo, were applied in 9 different points of quadriceps,6 points in the posterior thigh and two points in the gastrocnemius muscle, depending the group randomized, before and after each training session.
16001817|NCT02874976|Device|Placebo and active Phototherapy|Participants performed a aerobic training. Ninety-six subjects practice a regular aerobic exercise program on a treadmill was applied 3 times a week for 12 weeks,each session lasting 30 minutes, ranging between 70-80 % of maximum heart rate intensity and the evaluations are done monthly through a maximum progressive exercise protocol. Phototherapy, active or placebo, were applied in 9 different points of quadriceps,6 points in the posterior thigh and two points in the gastrocnemius muscle, depending the group randomized, before and after each training session.
16001818|NCT02874976|Device|Placebo and Placebo Phototherapy|Participants performed a aerobic training. Ninety-six subjects practice a regular aerobic exercise program on a treadmill was applied 3 times a week for 12 weeks,each session lasting 30 minutes, ranging between 70-80 % of maximum heart rate intensity and the evaluations are done monthly through a maximum progressive exercise protocol. Phototherapy, active or placebo, were applied in 9 different points of quadriceps,6 points in the posterior thigh and two points in the gastrocnemius muscle, depending the group randomized, before and after each training session.
16001819|NCT02874963|Procedure|Surgical Periodontal Treatment|In the patient's with periodontal disease at least one tooth extraction will be performed.
16001820|NCT02874963|Device|Non Surgical Periodontal Treatment includes scaling root planing with UDS-J Ultrasonic Scaler.|Previous to surgery procedures, in particular in the two groups with an adjunctive non surgical periodontal treatment such as full mouth tooth cleaning will be included: full-mouth scaling and root planing (FM-SRP) with ultrasonic device (UDS-J Ultrasonic Scaler, Guilin Woodpecker Medical Instrument) and periodontal curets for mechanical debridement of the supra- and sub-gingival plaque and calculus.
16001821|NCT02874963|Drug|Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%)|Previous to surgery procedures, in particular in the two groups with an adjunctive non surgical periodontal treatment such as full mouth tooth cleaning will be included mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%) for the 3 weeks after tooth extraction and cleaning.
16001822|NCT02874950|Other|office exercise training|The exercise group, did 6 months office exercise training.
16001823|NCT02874950|Other|ergonomic modification|The ergonomic modification group, followed 6 months modified office ergonomic modification.
16001824|NCT02874950|Other|Exercise and ergonomic|The mixture group, did 6 months exercise training and also followed 6 months modified office ergonomic modification.
16001825|NCT02874950|Other|Control|Control group did not do any exercise and did not follow any ergonomic modification.
16001826|NCT02874924|Drug|Rapamycin|treatment
16001827|NCT02874924|Drug|Placebo|control
16001828|NCT02874924|Drug|Rapamycin|No placebo control in this substudy group
16001829|NCT02874911|Other|General training|Advanced spinocerebellar disease receive 12 weeks of coordinative training based on commercially available videogames (Product names: Nintendo Wii ®, Microsoft XBOX Kinect®).
16001830|NCT02874898|Behavioral|Brief Imaginal Exposure|Psychoeducation and imaginal exposure components of full prolonged exposure, in which patients relive the trauma vividly and process thoughts and feelings related to it
16001831|NCT02874885|Procedure|Biospecimen Collection|Undergo collection of blood sample
16001832|NCT02874872|Behavioral|OASIS Collaborative|OASIS (Optimizing Antibiotic Stewardship in Skilled Nursing Facilities) is a system redesign of skilled nursing facility work systems
16001833|NCT02874846|Drug|Netarsudil ophthalmic solution 0.02%|Once daily in both eyes (OU) in the evening (PM) for 7 days
16001834|NCT02874846|Other|Netarsudil Ophthalmic Solution Vehicle|Once daily in both eyes (OU) in the evening (PM) for 7 days
16001835|NCT02874833|Other|Exercise|After performance diagnostics, participants will complete an 8-week supervised, individualized exercise program. Training will include up to 3 aerobic training sessions and up to two resistance training units per week.
16001836|NCT02874820|Radiation|[11C]BU99008|Baseline and blocked scans
16001837|NCT02874820|Drug|Idazoxan|Idazoxan dose up to 80mg
16001838|NCT02874807|Drug|Empagliflozin|
16001839|NCT02874807|Other|Placebo|
16001840|NCT02874794|Drug|LCZ696 (sacubitril/valsartan)|24/26mg, 49/51mg and 97/103mg oral, tablets.
16001841|NCT02874794|Drug|Enalapril|2.5mg, 5mg, and 10mg, oral, tablets
16001843|NCT02874794|Drug|Placebo of LCZ696|matching placebo (24/26mg, 49/51mg and 97/103mg) oral, tablets
16001844|NCT02874768|Drug|Dexmedetomidine|Patient receives continuous intravenous infusion of dexmedetomidine (infusion dosage range: 0.1 ~ 0.7 mcg/kg/h)
16001845|NCT02874768|Drug|Propofol|Patient receives continuous intravenous infusion of propofol (infusion dosage range: 0.3 ~ 1.6 mg/kg/h)
16001846|NCT02874755|Other|Tuberculosis Program|The intervention includes a variety of (1) non-financial incentives that are intended to reduce clinical and financial costs for presumptive TB patients and TB cases for diagnostic testing and treatment (free digital chest X-ray, free sputum microscopy, free or subsidized drug-susceptibility testing, free first-line anti-TB treatment) within the PPIA network, and (2) training or certified medical education (CME) sessions for the providers from the PPIA. Meanwhile, program marketing, CMEs, and other advocacy efforts are aimed to raise awareness in the communities.
16001847|NCT02874742|Drug|Lenalidomide|Cycles 1 through 6: lenalidomide 25 (milligram) mg orally on Days 1 through 14 and each cycle is of 21-days followed by maintenance treatment with lenalidomide 10 mg on days 1-21 throughout each 28-day cycle on Cycles 7 through 9. Beginning at Cycle 10, the lenalidomide dose will be increased to 15 mg unless there is a tolerability concern.
16001848|NCT02874742|Drug|Bortezomib|Bortezomib 1.3 mg/m^2 subcutaneously on Days 1, 4, 8, and 11 during Cycles 1-6.
16001849|NCT02874742|Drug|Dexamethasone|Dexamethasone 40 mg orally every week (20 mg on Days 1, 2, 8, 9, 15, and 16).
16001850|NCT02874742|Drug|Daratumumab|Daratumumab intravenously at a dose of 16 milligram per kilogram (mg/kg) weekly during induction treatment (Days 1, 8, and 15 of Cycles 1 through 4), and every 3 weeks during consolidation treatment (Day 1 of Cycles 5 and 6), followed by maintenance treatment with daratumumab every 4 or 8 weeks.
16001851|NCT02874729|Procedure|Venesection|Blood will be removed from the circulatory system through a cut (incision) or puncture for the purpose of analysis by qualified staff. Serum or plasma will be separated from the cellular fraction and stored for analyses.
16001852|NCT02874729|Procedure|Urine collection|Urine will be collected in appropriate sterile holders provided.
16001853|NCT02874729|Procedure|Sputum collection|Saliva will be collected in appropriate sterile holders provided.
16001854|NCT02874729|Procedure|Bronchoalveolar lavage|Bronchoscopy will be performed. Briefly, clinical care team will collect liquid after an instrument (bronchoscope) is passed through the nose or mouth into the lungs, and saline solution is squirted into a small part of the lung, then collected for analyses.
16001855|NCT02874716|Other|Tuberculosis Program (PPIA)|The intervention includes a variety of (1) non-financial incentives that are intended to reduce clinical and financial costs for presumptive TB patients and TB cases for diagnostic testing and treatment (free sputum microscopy, free digital chest X-ray, free or subsidized drug-susceptibility testing (DST), free first line anti-TB treatment), (2) training or certified medical education sessions for the providers from the PPIA, and (3) financial incentives to engaged providers for patient registration, diagnostic testing, treatment initiation, and treatment adherence. Meanwhile, health camps, advertising, and other advocacy efforts are aimed to raise awareness in the communities.
16001856|NCT02874703|Other|Cardiac MRI/MRS|
16001857|NCT02874690|Drug|Methylphenidate|single dose methylphenidate; 0.3mg/kg, up to 20mg, rounded to the nearest 2.5mg
16001858|NCT02874690|Drug|Placebo|Placebo pill identical in appearance to methylphenidate
16001859|NCT02874677|Other|Effort reeducation program|personalized reeducation program at a load level preceding hyperventilation
16001860|NCT02874664|Drug|Rovalpituzumab Tesirine|Rovalpituzumab tesirine is a DLL3 targeted antibody drug conjugate (ADC)
16001861|NCT02874651|Drug|Apatinib|Patients will take oral apatinib. The initial dose is 500 mg once daily. 28 days as one cycle. After 1 cycle, the dose will be escalated to 750 mg once daily in patients with good tolerance. Dose interruption or reduction is permitted in case of adverse events per protocol.
16001862|NCT02874651|Drug|Placebo|Patients will take oral placebo. The initial dose is 500 mg once daily. 28 days as one cycle. After 1 cycle, the dose will be escalated to 750 mg once daily in patients with good tolerance. Dose interruption or reduction is permitted in case of adverse events per protocol.
16001863|NCT02874638|Dietary Supplement|BASE egg protein|0.8 g/kg/d of protein provided as crystalline amino acid modeled after egg protein
16001864|NCT02874638|Dietary Supplement|BCAA-enriched egg protein|BCAA-enriched egg protein provided as crystalline amino acid.
16001865|NCT02874638|Dietary Supplement|small amount of essential amino acids|essential amino acids modeled after egg protein, provided as crystalline amino acid, which is equivalent to the amount of essential amino acid in BASE egg protein
16001866|NCT02874638|Dietary Supplement|large amount of essential amino acids|essential amino acids modeled after egg protein, provided as crystalline amino acid, which is equivalent to the amount of amino acid in BCAA-enriched egg protein
16001867|NCT02874625|Procedure|Dental restoration|
16001868|NCT02874612|Other|Psychosocial Survey Questionnaires|Young adults with Type 1 Diabetes Mellitus will be invited to participate in a observational study in which they complete psychosocial measures immediately after completing a readiness transition survey and then again 1 year later.
16001869|NCT02874599|Procedure|Dental restoration|
16001870|NCT02874586|Other|Plasma exchange combination of immunosuppressive regimens|
16001871|NCT02874573|Drug|Tocilizumab|Investigational agent
16001872|NCT02874573|Drug|Normal saline|Placebo
16001873|NCT02874547|Behavioral|Intervention|During an in-person visit, patients receive a pamphlet in english and spanish and a storytelling Digital Versatile Disc (DVD) (developed for this project from interviews with hypertensive patients), supplemented by motivational interviewing delivered by the CHW. The CHW explores the patient's motivation to change associated with hypertension and counsels on risk factor control (tobacco, diet, physical activity). Patients receive a followup telephone call from the CHW in 2 weeks, 4 weeks, 2 months to support any changes or goals discussed at first visit. Six months after first intervention visit, patients are invited to schedule an in-person visit with the CHW at the health center to discuss goals and provide support for change.
16001874|NCT02874534|Behavioral|Behavioral Activation|Treatment will consist of 15 weekly 45-minute sessions.
16001875|NCT02874534|Behavioral|Mindfulness Treatment|Treatment will consist of 15 weekly 45-minute sessions.
16001876|NCT02874521|Other|Intra-dialytic LF-EMS|Electrical muscle stimulation during haemodialysis
16001877|NCT02874521|Other|Intra-dialytic cycle training|Cycle training during haemodialysis
16001878|NCT02874495|Behavioral|Psychological tests|Related to affective and cognitive dimensions of pain.
16001879|NCT02874495|Device|Magnetic Resonance Imaging|"With a certain or uncertain anticipation phase of distension (warning light) followed or not by a rectal distension at the pain threshold previously determined, and then a retrospective quotation of pain during distension and the fear of pain induced by anticipation. Structural MRI and rest of functional connectivity measure MRI.
~With measure of heart rate variability."
16001880|NCT02874495|Behavioral|Heart Rate Variability|During MRI session, from the electrocardiographic signal. (measure of variations on R-R interval in milliseconds ms).
16001881|NCT02874469|Other|Diary|"The diary was specifically created for the purpose of the present study by personal working at ICU at CHRU of Lille (France).
~All relatives, doctors and paramedics close to the patient during his hospital stay are allowed to write some comments inside the diary when he is comatose.
~The diary will be implemented during the second period of the study within the first 8 hours after admission.
~It will be given to the patients themselves at discharge or to their relatives in case of in-hospital death. An anonymous copy will be kept by investigators."
16001882|NCT02874456|Other|virus detection|Men will give semen, urine and blood specimens 7 days after the beginning of clinical signs and 11, 20, 30, 60 and 90 days after. ZIKV RNA will be detected in seminal plasma, native semen cells and processed spermatozoa.
16001883|NCT02874443|Other|Knowledge Translation of labor management guidelines|
16001884|NCT02874430|Drug|Metformin Hydrochloride|Given orally
16001885|NCT02874430|Drug|Doxycycline|Given orally
16001886|NCT02874417|Behavioral|CAST psychoeducation|
16001887|NCT02874417|Behavioral|PHET|
16001888|NCT02874404|Drug|Ibrutinib|Given PO
16001889|NCT02874404|Other|Laboratory Biomarker Analysis|Correlative markers
16001890|NCT02874404|Drug|PI3K-delta Inhibitor TGR-1202|Given PO
16001891|NCT02874378|Drug|Dexmedetomidine|
16001892|NCT02874378|Drug|0.9%NaCl solution|
16001893|NCT02874365|Procedure|Endoscopic biopsies|intestinal biopsies
16001894|NCT02874352|Device|high resolution impedance manometry with Automated Impedance Manometry analysis|
16001895|NCT02874339|Device|High flow nasal oxygen therapy|In the optiflow group, oxygen will be administered through a heated humidifier (Airvo 2, Fisher and Paykel healthcare) and applied through large bore binasal prongs. Initial gas flow rate will be set at of 60 l/min and adjusted to 40-50 l/min based on patient's tolerance. FiO2 will be adjusted to maintain an SpO2 ≥ 92%. Initial temperature will be set at 37° and reduced according to patient's tolerance.
16001896|NCT02874339|Device|Non invasive ventilation|In the NIV group, NIV will be delivered through a face mask connected to a ventilator with pressure support applied in a noninvasive ventilation mode. The Pressure-support level will be adjusted to obtain an expired tidal volume of 6-8 ml/kg of predicted body weight and a respiratory rate of 25-30 b/min. PEEP (range 5-10 cm of water) and FiO2 will be adjusted to maintain an SpO2 ≥92% and to patient's comfort.
16001897|NCT02874326|Drug|Octreotide LAR|
16001898|NCT02874313|Device|Continuous positive airway pressure|Nocturnal continuous positive airway pressure by a nasal mask. CPAP pressure will be automatically titrated using a AutoSet device (ResMed).
16001899|NCT02874313|Drug|Pharmacological treatment|Conventional pharmacological treatment with oral antidiabetic drugs or insulin
16001900|NCT02874313|Other|Conventional anti-diabetic diet recommendations|
16001901|NCT02874300|Other|High intensity supervision arm|The higher-intensity supervision arm will comprise 6 occupational therapist (OT) home visits and 5 physiotherapist visits (1,1,2,2,6,12,18,24,30,36 and 52) plus supervised support from a rehabilitation support worker (RSW) twice a week for 3 months, once a week for 3 months, once a fortnight for 3 months and once a month for 3 months. Initially, and at review and progression points, the RSW will visit jointly with the therapists.
16001902|NCT02874300|Other|Moderate intensity supervision arm|The moderate-intensity supervision arm will be based on an ongoing Australian trial (83, 112). There will be 6 OT home visits and 5 physiotherapist visits (weeks 1,1,2,3,4,5,6,7,8,10,12) and three OT telephone calls (weeks 9,10,11). Participants will be expected to exercise independently in-between supervised sessions.
16001903|NCT02874287|Drug|Hydroxychloroquine Sulfate Tablets|Subjects are treated with oral hydroxychloroquine sulfate tablets 200mg twice daily for 20 weeks. All the interventions are built on the guideline-based secondary prevention of coronary heart disease medications.
16001904|NCT02874287|Drug|Placebo Tablets|Subjects are treated with oral placebo tablets 200mg twice daily for 20 weeks. All the interventions are built on the guideline-based secondary prevention of coronary heart disease medications.
16001905|NCT02874274|Behavioral|Standard of Care|
16001906|NCT02874274|Behavioral|Home Visit Program (HVP)|The study team will also contact the subject by phone within one week of each vaccination visit to assess for any adverse effects related to vaccination, included but not limited to: injection site pain, tenderness, swelling, pruritus, induration, or erythema; systemic symptoms such as fatigue, chills, headache, anorexia, malaise, myalgias, or anaphylaxis. Subjects will be contacted 90 days (+ 14 days) following Visit 3 to inquire about any additional symptoms and healthcare utilization.
16001907|NCT02874261|Device|Whole Body Periodic Acceleration|oscillating bed that the subject will lie on 3 days a week for 45 minutes at 140 cycles per minute.
16001908|NCT02874248|Drug|15 mg E4/3 mg DRSP|a single oral dose of 15 mg E4/3 mg DRSP (n=10) followed, after a washout of at least 14 days, by multiple oral doses of 15 mg E4/3 mg DRSP (n=10) once daily for 14 days
16001909|NCT02874248|Drug|30 mg E4/6 mg DRSP|a single oral dose of 30 mg E4/6 mg DRSP, followed, after a washout of at least 14 days, by multiple oral doses of 30 mg E4/6 mg DRSP once daily for 14 days
16001910|NCT02874248|Drug|60 mg E4/12 mg DRSP|a single oral dose of 60 mg E4/12 mg DRSP, followed, after a washout of at least 14 days, by oral doses of 60 mg E4/12 mg DRSP once daily for 14 days
16001911|NCT02874248|Drug|Visually matching placebo|a single oral dose of a placebo which visually matches the active medication, followed, after a washout of at least 14 days, by multiple oral doses of matching placebo once daily for 14 days
16001912|NCT02874248|Drug|75 mg E4/15 mg DRSP|a single oral dose of 75 mg E4/15 mg DRSP, followed, after a washout of at least 14 days, by oral doses of 75 mg E4/15 mg DRSP once daily for 14 days
16001913|NCT02874235|Behavioral|Receptive music therapy|16 sessions of a length of one hour comprising of receptive music psychotherapy with 5 - 15 minutes of music listening included
16002514|NCT02870023|Other|Balance training|
16001914|NCT02874235|Behavioral|Psychological treatment|16 sessions of a length of one hour comprising of verbal based psychotherapy based on principles from Narrative Exposure Therapy or Cognitive Behavioral Therapies
16001915|NCT02874222|Other|surveys completed by subject|Cohort study designed to validate previously identified associations between 10 specific SNPs and discontinuation of treatment with AIs due to the development of MSS among women with breast cancer.
16001916|NCT02874209|Other|sodium MRI|
16001917|NCT02874196|Procedure|Standard arthrography|
16001918|NCT02874196|Procedure|Dual energy arthrography|
16001919|NCT02874196|Procedure|Arthro-tomosynthesis|
16001920|NCT02874196|Procedure|Arthro-tomography|
16001921|NCT02874196|Procedure|Surgery on painful prosthesis|Possibly performed during 6 months from arthrography
16001922|NCT02874183|Behavioral|Pharmacist intervention|Pharmacist counseling and follow-up phone calls
16001923|NCT02874170|Other|Spectroscopy magnetic resonance of phosphorus 31|
16001924|NCT02874157|Biological|blood draw|
16001925|NCT02874144|Drug|AZ compound|40 mg three times daily po for 12 weeks
16001926|NCT02874144|Other|Collection of Biological Specimens|collection of biomarkers for analysis of nasal disease
16001927|NCT02874144|Drug|Intranasal corticosteroid|QD Nasal Spray
16001928|NCT02874144|Drug|Placebo|looks like AZ compound, made by same company, double blind. 40 mg three times daily po for 12 weeks
16001929|NCT02874131|Behavioral|Behavioral Activation|Behavioral activation
16001930|NCT02874131|Behavioral|Cognitive Processing Therapy|Cognitive processing therapy
16001931|NCT02874118|Behavioral|Fried scale for frailty assessement|
16001932|NCT02874105|Other|Group C: physiotherapy protocol with Conventional physiotherapy.|
16001933|NCT02874105|Other|Group S: physiotherapy protocol with Dynamic Humeral Centering.|
16001936|NCT02874079|Other|Blood sample and cotton skin swabs|
16001937|NCT02874066|Drug|PTV/r/OBV/DSV|Viekirax/Exviera for 12 weeks
16001938|NCT02874040|Procedure|Endoresection|Endoresection of the tumor scar
16001939|NCT02874040|Procedure|Laser diode|Transpupillary thermotherapy by laser diode on the tumor scar
16001940|NCT02874027|Other|The TBI patients with depression|The study is to investigate whether exist the relationship between depression and circadian rhythm of patients with TBI or not.
16001941|NCT02874014|Radiation|Hypofractionation Proton beam therapy with Concurrent Treatment of the Prostate and Pelvic Nodes|
16001942|NCT02873988|Other|bronchial epithelial cell culture|
16001943|NCT02873975|Drug|LY2606368|
16001944|NCT02873962|Drug|Bevacizumab|"Bevacizumab will be given intravenously at a pre-determined dosage
~One dose reduction will be allowed for Bevacizumab"
16001945|NCT02873962|Drug|Nivolumab|"Nivolumab injection is to be administered as an IV infusion at a pre-determined dosage.
~No dose reductions or escalations will be allowed for Nivolumab"
16001946|NCT02873962|Drug|Rucaparib|"Rucaparib will be taken orally twice daily on days 1-14 at a pre-determined dosage.
~Three dose reductions will be allowed for Rucaparib."
16001947|NCT02873949|Biological|Crevicular samples (1-10µl)|"In periodontitis patients: from 2 sites affected by periodontitis and 1 healthy site, 2 samples/site, before and after treatment
~In non-periodontitis individuals: 2 samples from 1 site"
16001948|NCT02873949|Biological|Saliva samples (1ml)|
16001949|NCT02873949|Other|Etiologic treatment|education on oral hygiene, scaling and root planing
16001950|NCT02873949|Other|Psychometric tests|Spielberger State-Trait Anxiety Inventory and Cohen Perceived Stress Scale
16001951|NCT02873936|Drug|Filgotinib|Tablet(s) administered orally once daily
16001952|NCT02873936|Drug|Placebo to match filgotinib|Tablet(s) administered orally once daily
16001953|NCT02873936|Drug|csDMARDs|csDMARDs may include one or two of the following: methotrexate (MTX), hydroxychloroquine or chloroquine, sulfasalazine, and/or leflunomide (combination of leflunomide and MTX is not allowed)
16001954|NCT02873923|Drug|undefined|Chemotherapy drug (meta-analyses of randomized trials)
16001955|NCT02873910|Dietary Supplement|IQP-AS-119|
16001956|NCT02873910|Dietary Supplement|Placebo|
16001957|NCT02873897|Dietary Supplement|Session A: Experimental products (selected enriched products)|
16001958|NCT02873897|Dietary Supplement|Experimental session: to select enriched products|
16001959|NCT02873897|Dietary Supplement|Session B: Control (standard products without enrichment)|
16001960|NCT02873897|Dietary Supplement|Control session|
16001961|NCT02873884|Behavioral|Case-management|
16001962|NCT02873871|Device|Standardized compressive dressing|Standardized compressive dressing
16001963|NCT02873871|Device|Hemostasis with TerumoBand®|Hemostasis with TerumoBand®
16001964|NCT02873858|Other|smell and taste tests|
16001965|NCT02873845|Other|Preliminary validation of the COBQoL questionnaire|
16001966|NCT02873832|Biological|Blood sample|
16001967|NCT02873832|Other|Flow cytometry|
16001968|NCT02873832|Other|western blot|
16001969|NCT02873819|Drug|GL-0817|GL-0817, IV at the dose 1.5 mg will be administered 3 times at 3-week intervals followed by 7 doses at 3-month intervals beginning at the Week 18 visit
16001970|NCT02873819|Drug|Hiltonol|Hiltonol will be administered intramuscularly at the dose of 1.4 mg as adjuvant to GL0817, 3 times at 3-week intervals followed by 7 doses at 3-month intervals beginning at the Week 18 visit
16001971|NCT02873819|Drug|Sargramostim|Sargramostim will be administered intramuscularly at the dose of 100 μg/m2, as adjuvant to GL0817, 3 times at 3-week intervals followed by 7 doses at 3-month intervals beginning at the Week 18 visit
16001972|NCT02873819|Drug|cyclophosphamide|cyclophosphamide will be administered IV at a dose of 200 mg/m2 (maximum dose 400 mg) one day prior to first three vaccinations of GL0817 with adjuvants
16001973|NCT02873819|Drug|Placebo|Placebo (normal saline) will be administered as per the schedule of cyclophosphamide and GL0817/adjuvants administration
16001974|NCT02873806|Procedure|Implantation of two iStent inject micro-bypass stents|- Implantation of two trabecular micro-bypass stents (iStent inject) in a standalone procedure (i.e., without cataract surgery).
16002299|NCT02871570|Drug|Rivipansel|A single dose of IV Rivipansel over 20 minutes
16001975|NCT02873806|Drug|Topical travoprost|- Topical travoprost (0.004%, 1 drop each evening in study eye) started on postoperative Day 1.
16001976|NCT02873806|Device|Two iStent inject micro-bypass stents|- Two trabecular micro-bypass stents (iStent inject) implanted in a standalone procedure.
16001977|NCT02873806|Drug|Tobramycin|"Topical antibiotic (tobramycin):
~1 drop four (4) times per day in the study eye for one week (in cases of allergy or contraindication, Polytrim (polymyxin B sulfate + trimethoprim sulfate ophthalmic solution, USP, or equivalent) may be used as an alternative medication) ."
16001978|NCT02873806|Drug|Dexamethasone|"Topical anti-inflammatory medication (dexamethasone ophthalmic suspension 0.1%):
~Week 1: 1 drop four (4) times per day in the study eye
~Week 2: 1 drop three (3) times per day in the study eye
~Week 3: 1 drop two (2) times per day in the study eye
~Week 4: 1 drop one (1) time per day in the study eye"
16001979|NCT02873793|Genetic|Extraction of total RNA from healthy and tumour tissues|
16001980|NCT02873767|Drug|PR1|"Active substance: UCB4019
~Route of Administration: subcutaneously"
16001981|NCT02873767|Other|PL1|"Active substance: Placebo
~Concentration: 0.9 % saline
~Route of Administration: subcutaneously"
16001982|NCT02873754|Behavioral|Cognitive Behavioral Counseling|Participants will receive five cognitive-behavioral counseling sessions designed to improve rates of smoking cessation, enhance relapse prevention, and increase physical activity.
16001983|NCT02873754|Behavioral|Mobile Contingency Management|Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence. They will also be asked to wear a fitness tracker to monitor physical activity (i.e., steps walked). Participants are provided monetary reward for videos that suggest smoking abstinence, and for fitness tracker readings that suggest increased physical activity.
16001984|NCT02873754|Drug|Bupropion|All participants who are medically eligible will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 6-month follow-up.
16001985|NCT02873754|Drug|Transdermal nicotine patch|Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant
16001986|NCT02873754|Drug|Nicotine polacrilex|Nicotine gum will be initiated at smoking quit date; 4 mg dose administered as needed
16001987|NCT02873754|Drug|Nicotine lozenge|Nicotine lozenge will be initiated at smoking quit date; 4 mg dose administered as needed
16001988|NCT02873741|Procedure|Perianal and Digital Anorectal Exam|The physician will inspect the outside of the anus and use a gloved finger to feel the anus for any masses.
16001989|NCT02873741|Procedure|Cervical Swabs|A speculum will be inserted into the vagina to visualize the cervix. The sample for research tests will be collected with one ThinPrep cytobroom inserted into the cervix. Collection will be same for the sample to be paced in the RNA storage solution for future biomarker studies.
16001990|NCT02873741|Procedure|Anal Swabs|The anal cytology specimen will be collected by inserting a saline moistened cotton-tipped swab into the anus, rotating it clock-wise for 20 seconds, and placed in SurePath. The first twenty participants will have anal cells collected in two different ways for validation/optimization: 1) saline moistened Dacron swab placed directly in ThinPrep medium and 2) Medscand Cytobrush Plus, a special brush, placed directly into ThinPrep medium. After validation/optimization is complete for up to 20 participants, the best collection method will be selected and will be used for all future enrolled participants.
16001991|NCT02873741|Procedure|High Resolution Anoscopy (HRA)|High Resolution Anoscopy is a procedure that allows for examination and evaluation of the anal canal. Using a small thin round tube called an anoscope, the anal canal is examined with a high resolution magnifying instrument called a colposcope. Application of a mild acidic liquid (acetic acid or diluted vinegar) or a brown iodine-based solution (Lugol's) onto the anal canal facilitates evaluation of abnormal tissue such as anal dysplasia. If abnormal staining is seen using acetic acid (dense white lesion) or Lugol's solution (bright yellow lesion) a biopsy of that area will be obtained.
16001992|NCT02873728|Procedure|Remote Ischemic Conditioning|Creation of Brief 5 min Ischemia to upper limb using a Blood pressure cuff
16001993|NCT02873728|Other|Control|Puting blood pressure cuff on upper limb and inflating to 10mmhg for 5 min
16001994|NCT02873715|Behavioral|Family-based treatment|Family based treatment as the invention to randomized participants. Family Based treatment utilizes behavior change techniques to target family-wide changes in diet and physical activity habits with the goal of promoting weight loss and subsequently healthy weight maintenance in all participants. Participants will have visits between 30 to 60 minutes as frequent as weekly and no longer than monthly over the two year study
16001995|NCT02873715|Behavioral|Usual Care|Usual care is a treatment that is normally provided to patients in pediatric offices by a pediatrician, physician assistant, or other primary care staff.
16001996|NCT02873702|Drug|Dexlansoprazole|Dexlansoprazole delayed-release capsules.
16001997|NCT02873702|Drug|Lansoprazole|Lansoprazole capsules.
16001998|NCT02873702|Drug|Placebo|Dexlansoprazole placebo-matching capsules.
16001999|NCT02873689|Drug|Dexlansoprazole|Dexlansoprazole delayed-release capsule
16002000|NCT02873689|Drug|Placebo|Dexlansoprazole placebo-matching capsules
16002001|NCT02873676|Behavioral|nutritional intervention|The intervention is made up of nutrition supplements and dietary pattern modification, which includes whey 30g/d(plus three times every week),vitamin D 1000IU, omega-3 fatty acid (DHA1200mg and EPA 800mg)
16002002|NCT02873676|Behavioral|resistance training program|The training program involve warm-up exercise, muscle strength training and relaxing
16002003|NCT02873676|Behavioral|lifestyle modification project|Lifestyle modification project is made up of multi-dimensional intensive nutritional intervention and resistance training
16002004|NCT02873676|Behavioral|control|The intervention involve dietary pattern modification and protein intake standardization
16002005|NCT02873663|Procedure|Plasma and head hair collection|Plasma and head hair collection
16002006|NCT02873650|Drug|dabrafenib|Single dose of 100 mg dabrafenib on Day 1
16002007|NCT02873637|Device|under sartorial catheter|
16002008|NCT02873637|Device|femoral catheter|
16002009|NCT02873624|Procedure|Laparoscopic cholecystectomy|
16002010|NCT02873611|Device|MRI|patients will undergo an additional MRI testing of apprx. 0.5-1 hour.
16002011|NCT02873611|Procedure|genicular ablation procedure|
16002300|NCT02871544|Other|BNP and NGAL|
16002301|NCT02871531|Procedure|Pneumatic retinopexy|
16002012|NCT02873598|Drug|FOLFIRINOX or gemcitabine/abraxane|Patients will have received induction chemotherapy for 3+ months with either FOLFIRINOX or gemcitabine/abraxane with at least stable disease.
16002013|NCT02873598|Radiation|SBRT|After completion of induction chemotherapy, stereotactic body radiation therapy (SBRT) will be administered in 3 fractions, every other day, on an outpatient basis. Dose escalation will start with dose level 1 (9 Gy x 3 fractions) and increase by 1 Gy per fraction at each dose level, dose level 2 will be 10 Gy x 3 fractions and dose level 3 will be 11 Gy x 3 fractions.
16002014|NCT02873585|Device|Stationary intraoral tomosynthesis|Bitewing radiographs using a stationary intraoral tomosynthesis unit
16002015|NCT02873585|Device|Standard conventional bitewing radiography|Bitewing radiographs using a stationary intraoral tomosynthesis unit will be performed after standard bitewing radiography
16002016|NCT02873572|Behavioral|step 1: online assessment|Anonymous psychiatric and behavioral assessments to evaluate in particular addiction or pathological gambling/gaming and behavioral profile of gamblers/gamers. Once questionnaire completed, if the subjects want to continue to participate, they sent their email to investigators.
16002017|NCT02873572|Behavioral|step2: biomarkers of gamblers/gamers|"For each arm, subjects were divided into 2 groups: dependant or not dependant gamblers/gamers. Investigators focused on decision-making biomarkers following the following flow-chart:
~psychiatric assesment and
~registration of brain activity during a decision-making task in conditions of uncertainty (IGT) with its version for HR-EEG validated by investigators (Giustiniani, 2015)."
16002018|NCT02873559|Drug|testosterone|Testosterone supplemented in 5 months
16002019|NCT02873559|Other|Progressive muscle training|Progressive muscle training during 4 months
16002020|NCT02873546|Device|transcranial Direct Current Stimulation (tDCS)|After locating the stimulation areas, treatment will be delivered during 30-minute session. Treatment will be occur 2 session per day during 5 consecutive days. Subjects will be monitored during tDCS sessions for any side effects or adverse events.
16002021|NCT02873533|Other|geriatric care and longitudinal follow up|geriatric care and longitudinal follow up
16002022|NCT02873520|Drug|Chemotherapy|Cisplatin：60mg/m2，5-FU：500mg/m2,Physiological saline 100ml:IV (in the vein) once a week with a total of six times.
16002023|NCT02873520|Biological|Precision Cell Immunotherapy|DC cell suspension (1×10*7 DC+physiological saline + 0.25% human bloodalbumin)1ml for each infusion, subcutaneous injection for each infusion, 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. PNAT/PMAT cell suspension (1-6×109 PNAT + physiological saline + 0.25% human bloodalbumin) 300ml for each infusion, IV (in the vein) for each infusion, 3 cycles, each cycle received one infusions on day 21, 42, 63.
16002024|NCT02873507|Other|MRI of donor liver prior to transplant|MRI of the on ice donor liver within the transport cooler on its way to the operating room
16002025|NCT02873494|Device|PHYSIOFLOW - PF05 Lab1TM|
16002026|NCT02873481|Behavioral|Centering Pregnancy Care plus Yoga (CPC+Y)|Gentle prenatal yoga for 30 minutes at the end of the Centering Pregnancy Care session
16002027|NCT02873468|Drug|Florence 30 μg/mL|10 mL, oral, twice a day.
16002028|NCT02873468|Drug|Florence 60 μg/mL|10 mL, oral, twice a day.
16002029|NCT02873468|Drug|Florence 90 μg/mL|10 mL, oral, twice a day.
16002030|NCT02873468|Other|Placebo|10 mL, oral, twice a day.
16002031|NCT02873455|Other|Short video clip including the circumstance of operation theater, and surgeon's interview|
16002032|NCT02873442|Procedure|TACE|Lipiodol 10-20ml,MMC 8～10mg,EADM20～ 40mg.According to tumor area of maximum diameter,0.1～0.2ml/cm2 Hepatic arterial infusion.
16002033|NCT02873442|Biological|Precision Cells|"DC cell suspension (1×107 DC+ physiological saline
~+ 0.25% human bloodalbumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. Precision Cell suspension (1-6×109 PMAT/PNAT + physiological saline + 0.25% human bloodalbumin) 300ml for each infusion, IV (in the vein) for each infusion 3 cycles, each cycle received one infusions on day 21, 42, 63."
16002034|NCT02873416|Drug|Chemotherapy|Cisplatin：60mg/m2，Gemcitabine：1g/ m2,Physiological saline 100ml:IV (in the vein) once a week with a total of six times.
16002035|NCT02873416|Biological|Precision Cells|Precision Cells DC cell suspension (1×10*7 DC+physiological saline + 0.25% human bloodalbumin)1ml for each infusion, subcutaneous injection for each infusion, 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. Precision Cell suspension (1-6×109 PNAT + physiological saline + 0.25% human bloodalbumin) 300ml for each infusion, IV (in the vein) for each infusion, 3 cycles, each cycle received one infusions on day 21, 42, 63.
16002036|NCT02873403|Device|KNEEMO knee brace|Bespoke knee brace made by additive manufacturing
16002037|NCT02873403|Device|Popular knee brace|Customized knee brace used in the management of medial knee ostearthritis
16002038|NCT02873390|Biological|HerinCAR-PD1 cells|herinCAR-PD1 cells transfusion: (1-5×107/kg herinCAR-PD1 + physiological saline + 0.25% human alloalbumin) 300ml for each infusion. IV (in the vein) for each infusion, 2 cycles, each cycle received one infusions on day 21, 43.
16002039|NCT02873377|Drug|Nicorette Gum|GlaxoSmithKline Nicorette Gum (nicotine replacement therapy)
16002040|NCT02873377|Drug|Nicoderm CQ|GlaxoSmithKline Nicoderm CQ (nicotine replacement therapy)
16002041|NCT02873377|Other|Smoking Quitline Referral|Fax referral to the State smoking Quitline
16002042|NCT02873377|Behavioral|Behavioral Smoking Cessation Counseling|One time face-to-face smoking cessation counseling and follow-up phone call
16002043|NCT02873364|Drug|Vitamin D3 (High dose)|Daily 4000 unites vitamin D
16002044|NCT02873364|Drug|Vitamin D3 (Low dose)|Daily 600 unites vitamin D
16002045|NCT02873351|Drug|carbidopa-levodopa 25-100 mg|included in arm description
16002046|NCT02873351|Drug|placebo for carbidopa-levodopa 25-100 mg|included in arm description
16002050|NCT02873325|Other|antiviral therapies for CMV and/or ADV|salvage antiviral treatments for ADV and/or CMV
16002051|NCT02873312|Device|StimRouter|"The StimRouter System is a neuromodulation system consisting of the following components and accessories:
~An implantable multi-electrode lead with integrated receiver in loader and surgical tools for implantation of the implantable lead.
~An external programming system with a clinician programmer, a clinician programmer cradle and charger, an external pulse transmitter tester and accessories.
~A patient-operated system with an external pulse transmitter (StimRouter EPT), a disposable StimRouter Electrode, an external patient programmer and charger, and accessories."
16002052|NCT02873299|Other|10 Hz rTMS of the right dorsolateral prefrontal cortex|Ten sessions of 10 Hz rTMS of the right dorsolateral prefrontal cortex
16002053|NCT02873299|Other|20 Hz rTMS of the right dorsolateral prefrontal cortex|Ten sessions of 20 Hz rTMS of the right dorsolateral prefrontal cortex
16002054|NCT02873286|Biological|MVA-BN-RSV|MVA-mBN294B
16002055|NCT02873286|Other|Placebo|Tris Buffered Saline, sterile
16002056|NCT02873273|Drug|Dexamethasone|Sustained delivery system containing 5.0 mg of dexamethasone programmed to release an estimated 10 μg per day
16002057|NCT02873260|Biological|TetraVax-DV-TV005|TetraVax-DV-TV005 contains 10^3.3 plaque forming units (PFU)/mL of rDEN1Δ30, 10^4.3 PFU/mL of rDEN2/4Δ30(ME), 10^3.3 PFU/mL of rDEN3Δ30/31-7164, and 10^3.3 PFU/mL of rDEN4Δ30. The vaccine is administered in 0.5 mL containing 10^3.0 PFU of each component with the exception of rDEN2/4Δ30 that is given at a dose of 10^4 PFU. TetraVax-DV-TV005 is administered by subcutaneous injection in the deltoid region of the upper arm.
16002058|NCT02873260|Biological|rDEN3Δ30|Administered at a dose of 10^4 PFU by subcutaneous injection in the deltoid region of the upper arm.
16002059|NCT02873260|Biological|Placebo|Administered at a volume of 0.5 mL by subcutaneous injection in the deltoid region of the upper arm.
16002060|NCT02873234|Drug|Traditional Chinese Medicine|Participants are treated with TCM twice per day according to syndrome differentiation. For example, the syndrome of one participant with depression is kidney deficiency. He will take Zishui Qinggan Yin twice per day before the breakfast and dinner.
16002061|NCT02873234|Drug|Antidepressants|Participants are treated with different antidepressants. The dosage, frequency and duration are determined according to guideline.
16002062|NCT02873221|Drug|Ubrogepant|Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
16002063|NCT02873221|Drug|Placebo-matching Ubrogepant|Ubrogepant placebo-matching tablet orally for the treatment of a qualifying migraine attack.
16002064|NCT02873221|Drug|Usual Care|Treatment for a migraine as prescribed by the physician as standard of care in clinical practice.
16002065|NCT02873208|Drug|ALKS 3831|Coated bilayer tablet containing 10 mg, 15 mg or 20 mg olanzapine and 10 mg samidorphan
16002066|NCT02873195|Drug|Atezolizumab|Given IV
16002067|NCT02873195|Biological|Bevacizumab|Given IV
16002068|NCT02873195|Drug|Capecitabine|Given PO
16002069|NCT02873195|Other|Laboratory Biomarker Analysis|Correlative studies
16002070|NCT02873195|Other|Placebo|Given IV
16002071|NCT02873182|Device|Autonomic nervous system monitoring|Two intracorporal electrode needles will be inserted beneath the skin of the genitalia. After insertion, the electrodes will be secured and connected by leads to two standard neurophysiological devices for differential amplification, display, and storage. Smooth muscle free-running (continuous) and stimulated EMG will be recorded.
16002072|NCT02873169|Other|Implantable cardioverter-defibrillator|Collection of clinical, biological, hemodynamic and rhythmic data
16002073|NCT02873156|Drug|E2027|Participants will receive E2027 capsules, orally once daily (QD) on Days 1 to 14 after an overnight fast of at least 10 hours. E2027 will be administered orally with 240 milliliter (mL) (8 fluid ounces) of water.
16002074|NCT02873156|Drug|E2027 matched placebo|Participants will receive E2027 matched placebo capsules, orally once daily (QD) on Days 1 to 14 after an overnight fast of at least 10 hours. E2027 matched placebo will be administered orally with 240 mL (8 fluid ounces) of water.
16002075|NCT02873143|Other|No intervention|No intervention
16002076|NCT02873130|Behavioral|Telepractice Global Voice Prevention Model|
16002077|NCT02873130|Behavioral|In-person Global Voice Prevention Model|
16002078|NCT02873130|Behavioral|Telepractice, Vocal Hygiene and Vocal Education|
16002079|NCT02873117|Other|Prostate biopsy, prostatectomy or prostate resection|Collection of prostate examination
16002080|NCT02873104|Device|truSculpt rf device|radiofrequency device
16002081|NCT02873091|Procedure|Epidural analgesia|
16002082|NCT02873091|Procedure|Continuous epidural infusion|
16002083|NCT02873091|Procedure|Intermittent epidural bolus|
16002084|NCT02873091|Drug|ropivacaine|
16002085|NCT02873091|Drug|sufentanil|
16002086|NCT02873078|Behavioral|Internet-delivered Cognitive behavior therapy|The treatment is delivered via an online platform and is based on interventions for adults, adolescents and children tested in previous trials. Therapists are CBT-psychologists och students in clinical psychology under supervision.
16002087|NCT02873065|Drug|Ilaprazole|
16002088|NCT02873065|Drug|Esoprazole|
16002089|NCT02873052|Device|MyoVista|The clinical set up of MyoVista™ is identical to that of a traditional 12-lead ECG but it obtains and processes signal information in a way that permits much greater resolution of the electrical activity associated with the myocardium MyoVista.
16002090|NCT02873026|Drug|Triamcinolone Acetonide|Following the repair of the open globe eye trauma, the use of Triamcinolone Acetonide will be investigated
16002091|NCT02873000|Behavioral|Incentive Spirometry|Incentive Spirometer is a tool that allows for deep breathing in a controlled setting while providing the user with visual feedback demonstrating the inspiratory volume of each breath.
16002092|NCT02872974|Other|GDM|Exposure to GDM during fetal life
16002093|NCT02872948|Genetic|Diagnostic|
16002094|NCT02872935|Drug|Glycopyrrolate|.2mg of Glycopyrrolate will be given intravenously with the administration of the spinal dose
16002095|NCT02872935|Drug|Normal Saline|1ml of normal saline will be given intravenously with the administration of the spinal dose
16002165|NCT02872402|Behavioral|Active control lifestyle intervention|Participants in the control group will receive standard lifestyle recommendations in the form of written information at each visit.
16002302|NCT02871531|Procedure|Vitrectomy|
16002515|NCT02870023|Other|Strength training|
16002096|NCT02872922|Other|Low intensity therapeutic ultrasound|The ultrasound equipment (Sonopulse III, 1 MHz, IBRAMED, Brazil) was calibrated with the radiation force method. In study, the head of the transducer will be positioned and applied for 5 min over the brachial artery at the same point that will be evaluated the endothelium function (Cruz et al., 2016). Continuous waveforms of ultrasound therapy (CWUT) are applied in the stationary mode for 5 minutes at a spatial averaged temporal intensity (SATA) of 0.4 W/cm2 using a transducer 1-MHz. A pulsed waveform of ultrasound therapy (PWUT) are applied (5 minutes) with a 20% duty cycle (2 ms on, 8 ms off), which represents a constant intensity of 0.08 W/cm2 SATA. In the placebo intervention, all of the procedures above are repeated, but with the ultrasound equipment powered off (Cruz et al., 2016).
16002097|NCT02872909|Device|Ambulight (Ambicare Health)|"battery-operated low irradiance red light LED (skin cancer plaster)"
16002098|NCT02872896|Procedure|Orthopedic, urologic or general surgery|Patients having orthopedic, urologic or general surgery may have the ClearSight device; patients having orthopedic, urologic or general surgery may have the non-ClearSight device to monitor subject blood pressure during surgery
16002099|NCT02872883|Procedure|Expectant management|
16002100|NCT02872883|Procedure|Minimal Vaginal examinations (only when necessary)|
16002101|NCT02872883|Procedure|Active management|
16002102|NCT02872883|Procedure|Routine vaginal examinations|
16002103|NCT02872870|Behavioral|auditory lexical decision task|
16002104|NCT02872870|Device|electroencephalogram|
16002105|NCT02872857|Drug|Placebo|Placebo will match drug capsules.
16002106|NCT02872857|Drug|8mg galantamine twice daily|Drug will be administered within 36 hours of hospitalization and continued for 90 days.
16002107|NCT02872857|Drug|12mg galantamine twice daily|Drug will be administered within 36 hours of hospitalization and continued for 90 days.
16002108|NCT02872831|Device|22G SharkCore™ needle|The 2 dedicated passes from the SharkCore™ needle will be placed in a jar with formaldehyde-based fixative and sent for routine histopathology evaluation. The cassette will be processed, embedded in paraffin, and then prepared in hematoxylin and eosin to be evaluated by one pathologist, who was blinded to the randomization sequence, for the presence of a histologic tissue. If adequate histologic tissue is present, the specimen will be graded as optimal or suboptimal.
16002109|NCT02872831|Device|22G BNX EUS-FNA Needle|Aspirates will be placed onto glass slides and preserved with Diff-Quik stain (American Scientific Products, McGraw Park, Illinois, USA). In addition, a smear will also be placed in alcohol for Papanicolaou staining. Any additional material was sprayed into Hanks's solution and sent for cell block processing. The cytology technician or cytopathologist on site will verify adequacy of specimens. At least two passes will be obtained from the lesion unless the technician established the presence of malignant appearing cells.
16002110|NCT02872818|Drug|17β estradiol hemihydrate|4mg/kg/day for 20 days
16002111|NCT02872818|Drug|Metformin|50 mg/kg/day last 10 days
16002112|NCT02872818|Drug|medroxyprogesterone acetate|1mg/kg/day last 10 days
16002113|NCT02872805|Other|PEPFAR Enhanced Standard of Care (PESCA)|Standardized materials will be provided to PEPFAR supported clinical sites to assist clinic teams with supporting patients in the transition from pediatric to adult medical care
16002114|NCT02872805|Behavioral|Peer Transition Advocate (PTA)|The PTAs will be present during patient clinic appointments to mentor and support participants in the development of independent health care behaviors. They will engage patients in role-plays to simulate appointments in adult practices. The PTAs will accompany patients during the transition process to the adult providers, to inform, support, and facilitate their successful transition to adult care. PTA duties, performed in the clinic and in the community, will include psychosocial support; facilitation of disclosure; adherence counseling, monitoring, and support; screening of patients for significant signs of illness and referral for care; and tracking and defaulter tracing of patients. PTA will support counseling and testing services for adolescents within the facilities. For those perinatally-infected, important care and support services include disclosure and stigma issues.
16002115|NCT02872792|Device|Early mobilisation with cyclo ergometer|Early mobilisation with cyclo ergometer is done daily during hospitalization for sepsis in an Intensive Care Unit
16002116|NCT02872792|Other|Standard physiotherapy|Standard physiotherapy included passive and active manual mobilization, sitting on bed, sitting in chair, walking
16002117|NCT02872779|Procedure|Blood sampling for free mutant DNA analysis|Blood sampling for Patients Treated for Metastatic Colorectal cancer
16002118|NCT02872766|Device|CXL Myopia|Applying riboflavin 0,22% to 0,25 % up to 20 minutes . Then, the eyes are exposed to UVA light with the KXL II system according to the programmed treatment pattern.
16002119|NCT02872753|Biological|ACP|Autologous Conditioned Plasma will be obtained directly in the operatory room from the peripheral venous blood of the patient, and injected intra-articularly at the end of arthroscopic meniscectomy
16002120|NCT02872753|Other|Standard Meniscectomy|Patients will receive standard arthroscopic meniscectomy
16002121|NCT02872740|Procedure|Embolization of Left Gastric Artery|Left gastric artery will be embolized to stasis with 150-250 micron polyvinyl alcohol particles
16002122|NCT02872740|Procedure|Embolization of Gastroepiploic Artery|Gastroepiploic artery will be embolized to stasis with 150-250 micron polyvinyl alcohol particles
16002123|NCT02872727|Other|Respiratoy health, biological investigations|Once the subjects have agreed to participate, self-surveys on their lifestyle habits will be filled and EACand urine samplings will be taken during one same consultation, in addition to exhaled CO and No measurements. This consultation will also include a spirometry test. The employees' workstation data (and their evolution since the first study) will be collected. Therefore, the volunteers' participation is limited to one single visit including non-invasive examinations and self-surveys.
16002124|NCT02872714|Drug|pemigatinib|Pemigatinib once a day by mouth for 2 consecutive weeks and 1 week off therapy.
16002125|NCT02872714|Drug|pemigatinib|Pemigatinib once a day by mouth continuously.
16002126|NCT02872701|Drug|OTL38 for Injection|Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL
16002127|NCT02872701|Device|Near infrared camera imaging system|Near infrared camera imaging system
16002128|NCT02872701|Procedure|Endoscopic or Thoracic Surgery|Endoscopic or Thoracic Surgery
16002129|NCT02872688|Other|GanedenBC30|
16002212|NCT02872116|Drug|Capecitabine|Specified dose on specified days
16002130|NCT02872675|Dietary Supplement|HOST-DM059|"Experimental Supplement: HOST-DM059.
~Participants will be asked to orally consume one powdered sachet each day, at the same time in the morning, reconstituted in tea/coffee/fruit juice, or sprinkled over cereal etc. Whichever method of consumption is chosen, this must be kept consistent across both supplementation phases."
16002131|NCT02872675|Dietary Supplement|Maltodextrin|Placebo Comparator: Maltodextrin.
16002132|NCT02872649|Drug|Dabigatran|
16002133|NCT02872649|Drug|Phenprocoumon|
16002134|NCT02872636|Device|Spinal catheter insertion with extracorporeal filtration of CSF|Extracorporeal filtration of CSF
16002135|NCT02872623|Radiation|Enterography-MRI without enteroclysis|
16002136|NCT02872623|Radiation|enteroCT with enteroclysis|
16002137|NCT02872610|Behavioral|Self-help Online|"The internet-based self-help program consist of 6 modules that each take a week to complete. Every module consists of a theoretical section, a compulsory exercise, and several optional exercises: Participants are encouraged to spend a minimum of 30 minutes every day with the self-help program. On the website, the participants in the intervention condition may also access an Acute Help page where information on help options are listed and a My Profile page where changes to login and contact details may be made, also, the informed consent form is found here. Participants may furthermore access a message system where they can write questions to the trial manager."
16002138|NCT02872597|Drug|Ipratropium|
16002139|NCT02872597|Drug|0.9% Sodium Chloride|
16002140|NCT02872597|Drug|Albuterol|"albuterol prescribed by the clinical team per our PICU's Asthma Carepath"
16002141|NCT02872597|Drug|corticosteroids|systemic (IV or enteral) corticosteroid prescribed by the clinical team, typically methylprednisolone IV
16002142|NCT02872584|Drug|Prednisone|prednisone treatment as required by dermatological condition (pemphigus/pemphigoid)
16002143|NCT02872571|Drug|Intramuscular Islet Autograft|Intramuscular Islet Autograft After Extensive Pancreatectomy
16002144|NCT02872558|Other|Acute Otitis Media Choice Decision Aid|Decision Aid
16002145|NCT02872558|Other|Usual Care|Usual Care
16002146|NCT02872545|Procedure|Rest tomoscintigraphy in forward tilted|Rest tomoscintigraphy in forward tilted position
16002147|NCT02872545|Procedure|Rest tomoscintigraphy in semi sitting position|Rest tomoscintigraphy in forward tilted position, followed by a second rest tomoscintigraphy in semi sitting position, after max 30 min
16002148|NCT02872545|Procedure|Rest tomoscintigraphy in dorsal decubitus position|Rest tomoscintigraphy in forward tilted position, followed by a second rest tomoscintigraphy in semi sitting position, after max 30 min
16002149|NCT02872532|Procedure|Testicular tissue cryopreservation|Testicular tissue will be removed
16002150|NCT02872519|Drug|(S)-4-(3-[18F]Fluoropropyl)-L-glutamic acid (18F-FSPG)|Given by IV
16002151|NCT02872519|Procedure|Positron Emission Tomography|Undergo scan
16002152|NCT02872519|Other|Laboratory Biomarker Analysis|Laboratory Biomarker Analysis
16002153|NCT02872506|Drug|Anti TNF|Patients are admitted to day hospital with blood test less than 7 days. In the absence of contraindications, hydrocortisone infusion 200 mg will be conducted for 15 minutes followed by anti-TNF treatment infusion over 2 hours for the first three sessions. The following infusions of anti-TNF therapy will be on the same terms without hydrocortisone, every 4 to 8 weeks, in doses of 5-10mg/kg. Adverse effect most frequently reported was URTI. The most serious adverse reactions, were a reactivation of hepatitis B, congestive heart failure, serious infection, serum hypersensitivity reactions, blood diseases, systemic lupus erythematosus / lupus-like syndrome, demyelinating disorders, hepatobiliary metabolism disorders. The QOL will be assessed by IBDQ score at the inclusion visit before the first infusion and at 6 months.
16002154|NCT02872506|Procedure|ileocecal resection|The operation is performed by laparoscopy or laparotomy. Hospital stay is on average 6 days. Preparation for the intervention is sometimes required 3 weeks to 1 month before the procedure to avoid risk situations.The main risk of the intervention is the anastomotic fistula. This risk of anastomotic leakage mainly concerns malnourished patients operated within the context of abdominal sepsis (abscess). An assessment protocol of post-operative pain, every 3 hours, is now well codified in routine surgery. The QOL will be assessed by the IBDQ score before surgery and at 6 months.
16002155|NCT02872493|Procedure|Small bowel length measurement|The total length of the small bowel with be measured at the time of the bariatric surgical operation.
16002156|NCT02872480|Other|ACTIVE Training|Participants will be asked to complete aerobic exercise on a stationary bike during 30-minute sessions. Intensity will progress under a standard procedure for healthy participants (60-80% of VO2max) and as tolerated by concussed participants (starting at 60% of symptom exacerbation).
16002157|NCT02872467|Drug|Syntocinon treatment|24 IU twice daily (A single dose will be delivered consisting of 6 intranasal insufflations (3 in each nostril) which is equivalent to a total of 24 international units (IU) of oxytocin twice daily).
16002158|NCT02872467|Other|Placebo|Placebo nasal spray vials will contain the same ingredients in the nasal preparation, but without oxytocin.
16002159|NCT02872454|Behavioral|Text Messaging|Each week, enrolled participants will receive daily text messages from one of three randomly assigned psychotherapeutic modalities-cognitive restructuring, behavioral activation, and techniques based on Acceptance and Commitment Therapy (ACT)-for a total of 12 weeks. The messages were developed, reviewed, and refined by a multidisciplinary team of experienced therapists, including social workers, psychologists, and psychiatrists.
16002160|NCT02872441|Biological|blood sample|One blood sample of 50 milliliter 24 hours after the inclusion
16002161|NCT02872428|Drug|Valproic Acid|By infusion over 1 hour
16002162|NCT02872428|Drug|Isotonic saline solution|By infusion over 1 hour
16002163|NCT02872415|Biological|Blood puncture site|Blood puncture site
16002164|NCT02872402|Behavioral|Lifestyle intervention|Women who are still breastfeeding at the first postpartum visit will be encouraged to pursue. References to local breastfeeding supporting groups will be done, if needed. The intervention will be conducted in order to reach recommendations for food servings and nutrient needs. Particular attention will be paid to increase fruits, vegetables, fish and whole grains intake, and decrease added sugars and high fat meat/dairy products. Women will be strongly encouraged to be active at least 150 min/week. They will be provided with targeted strategies for exercising, types of exercises and tips for including physical activity into the daily routine as well as fun exercises for the whole family.
16002213|NCT02872116|Drug|Leucovorin|Specified dose on specified days
16002166|NCT02872389|Drug|Sevoflurane|Anesthesia was maintained with sevoflurane in patients undergoing arthroscopic knee surgery under general anesthesia. End-tidal concentration of sevoflurane was maintained at age-corrected 1 minimum alveolar concentration throughout the study period.
16002167|NCT02872389|Drug|Desflurane|Anesthesia was maintained with desflurane in patients undergoing arthroscopic knee surgery under general anesthesia. End-tidal concentration of desflurane was maintained at age-corrected 1 minimum alveolar concentration throughout the study period.
16002168|NCT02872363|Other|Intervention A - Behavioural Regulation|"SMS reminder with 'Behavioural Regulation' message:
~'Don't forget to make a diary note of your screening mammogram apt at (time)(date) at (site). Call 02033136644 to rearrange'"
16002169|NCT02872363|Other|Intervention B - Priority|"SMS reminder with 'Priority' message:
~'Is your breast screening appointment on your priority list? Apt at (time), (date) at (site). Call 02033136644 to rearrange.'"
16002170|NCT02872350|Device|Abdominal ultrasound|Techniques and predictive characteristics of the combination abdominal ultrasound abdomen and shot in the prognostic assessment of ECUN in premature under 33SA.
16002171|NCT02872337|Behavioral|Preoperative Physical Therapy Session|This was a one-on-one preoperative physical therapy session on preoperative education. These patients were also given access to a surgery specific web-based microsite
16002172|NCT02872337|Behavioral|Group Preoperative Education Session (per the standard of care)|
16002173|NCT02872324|Other|Procurement questionnaires|
16002174|NCT02872311|Biological|High Dose Influenza vaccine|Licensed and FDA approved Fluzone HD vaccine to be administered to study participants
16002175|NCT02872311|Biological|Adjuvanted Influenza vaccine|Licensed and FDA approved FluAd vaccine to be administered to study participants
16002176|NCT02872311|Biological|Standard Dose Influenza vaccine|Licensed and FDA approved Fluvirin vaccine to be administered to study participants
16002177|NCT02872311|Biological|Recombinant Influenza vaccine|Licensed and FDA approved FluBlok vaccine to be administered to study participants
16002178|NCT02872298|Device|Targeted Lung Denervation (TLD)|The Nuvaira Lung Denervation System, manufactured by Nuvaira, Inc., is intended to deliver TLD Therapy using predetermined radiofrequency (RF) energy over a predetermined period of time to ablate airway nerve trunks which are located on the outside of the main bronchi.
16002179|NCT02872285|Drug|Drug: LYC-30937-EC|
16002180|NCT02872285|Drug|Placebo|
16002181|NCT02872272|Drug|Treatment with Amikacin|Aminoglycosides. Blood sampling for pharmacokinetic evaluation
16002182|NCT02872259|Drug|BGB324+pembrolizumab|Combination
16002183|NCT02872259|Drug|BGB324+dabrafenib and trametinib|Combination
16002184|NCT02872259|Drug|pembrolizumab|Monotherapy
16002185|NCT02872259|Drug|dabrafenib and trametinib|Combination
16002186|NCT02872246|Drug|BAY 987516|Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.
16002187|NCT02872246|Drug|SPF 15 Control|Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.
16002188|NCT02872233|Drug|BAY 987519|Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.
16002189|NCT02872233|Drug|SPF 15 Control|Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.
16002190|NCT02872220|Drug|SPF 50 Y65 110 (BAY987519)|Application of 200 µL in an occlusive patch of Webril (0.150 ± 0.010 mg) compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.
16002191|NCT02872220|Drug|SPF 50 Y51 002 (BAY987519)|Application of 200 µL in an occlusive patch of Webril compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.
16002192|NCT02872220|Drug|SPF 15 V27 104 (BAY987519)|Application of 200 µL in an occlusive patch of Webril compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.
16002193|NCT02872220|Drug|Sodium chloride [NaCl]|Negative control (200 µL, 0.9% sodium chloride [NaCl]) after a single 24 h application of test materials followed by irradiation with ultraviolet A (UVA) and ultraviolet B (UVB).
16002194|NCT02872207|Drug|BAY 987516 (Y65-122)|5 µL in one eye
16002195|NCT02872207|Drug|BAY 987516 (Y65-118)|5 µL in one eye
16002196|NCT02872207|Drug|Control|5 uL in other eye
16002197|NCT02872194|Drug|BAY987516, Y55-170|10 uL in one eye
16002198|NCT02872194|Drug|BAY987516, X72-151|10 uL in one eye
16002199|NCT02872194|Drug|BAY987516, Y49-034|10 uL in one eye
16002200|NCT02872194|Drug|Standard shampoo mixture (control)|10 uL in one eye
16002201|NCT02872181|Procedure|Supine|Placed in Supine position
16002202|NCT02872181|Procedure|Left uterine displacement|Placed in 15 degrees left uterine displacement
16002203|NCT02872168|Other|Not intervention|None. there is no modification in the treatment of patients. A urine collection is carry out in patients during the day of their enrolment.
16002204|NCT02872155|Other|Oral hydratation|500 mL of water two hours before computed tomography and 2000 milliliters 24 hours after performing computed tomography
16002205|NCT02872155|Drug|Bicarbonate endovenous hydratation|Intravenous hydration: sodium (1.6 molar) Bicarbonate 3 mL / kg / h starting one hour before the computed tomography and sodium bicarbonate (1/6 M) 1 mL / kg / h during the hour after computed tomography.
16002206|NCT02872155|Drug|Saline endovenous hydratation|If there is contraindication for administration of bicarbonate the pattern of intravenous hydration is performed with saline solution: 3 ml / kg / h for 1 hour before the procedure and normal saline 1 mL / kg / hour for hour after computed tomography.
16002207|NCT02872142|Biological|Albutein 5%|Albutein is manufactured from human plasma. The dose of Albutein 5% for replacement following plasma removal will be calculated based on gender, weight, and the hematocrit of the participant.
16002208|NCT02872142|Procedure|Plasma Exchange|Plasma Exchange will be performed using albutein 5% as the replacement solution.
16002209|NCT02872116|Drug|Nivolumab|Specified dose on specified days
16002210|NCT02872116|Drug|Ipilimumab|Specified dose on specified days
16002211|NCT02872116|Drug|Oxaliplatin|Specified dose on specified days
16002215|NCT02872103|Drug|F-627|F-627 subcutaneous injection on Day 2 of TA chemotherapy cycles. TA chemotherapy treatments are part of standard-of-care and not the study
16002216|NCT02872103|Drug|Placebo|Placebo subcutaneous injection on Day 2 of the first TA chemotherapy cycle. TA chemotherapy treatments are part of standard-of-care and not the study.
16002217|NCT02872090|Drug|Indacaterol|inhalation
16002218|NCT02872090|Drug|Glycopyrronium|inhalation
16002219|NCT02872090|Drug|Tiotropium|inhalation
16002220|NCT02872090|Drug|Placebo|
16002221|NCT02872090|Procedure|photoplethysmography|inhalation
16002222|NCT02872077|Other|Auricular acupuncture|
16002223|NCT02872064|Drug|Verteporfin|Verteporfin (which is marketed under the brand name Visudyne) is the photosensitizer. Verteporfin is a benzoporphyrin derivative which is clinically active when formulated with liposomes. By itself the clinically recommended dose of Verteporfin is not cytotoxic. It produces cytotoxic agents only when activated by light in the presence of oxygen. When energy absorbed by the porphyrin is transferred to oxygen, highly reactive short lived singlet oxygen is generated. Singlet oxygen causes damage to biological structures, leading to local vascular occlusion, cell damage and cell death.
16002224|NCT02872051|Behavioral|IBBIS mental health care and standard vocational rehabilitation|"Standard vocational rehabilitation.
~Stepped mental health care provided by the IBBIS mental health care team (e.g. nurses, psychologists, and medical doctors) with the treatment modalities:
~Psychoeducation Bibliotherapy Cognitive-behavior Therapy Monitoring and reassessment"
16002225|NCT02872051|Other|Integrated mental health care and vocational rehabilitation|"Integrated mental health care and vocational rehabilitation provided by the IBBIS team. The IBBIS team is composed by employment specialists from the municipal job centers and health care professionals from the mental health services (e.g. nurses, psychologists, and medical doctors).
~Mental health care is provided according to a stepped care model with the following treatment modalities:
~Psychoeducation Bibliotherapy Cognitive-behavior Therapy Monitoring and reassessment
~Vocational rehabilitation is inspired by Individual Placement and Support and is a workplace-oriented intervention with problem-solving conversations as a core element"
16002226|NCT02872038|Drug|Cefepime|Cefepime intraperitoneal continuous dosing
16002227|NCT02872038|Drug|Cefazolin plus Ceftazidime|
16002228|NCT02872025|Drug|Pembrolizumab|Injected intralesionally
16002229|NCT02872025|Biological|Intralesional mRNA 2752|Injected intralesionally
16002230|NCT02872012|Device|Cryoanesthesia device|The study will be carried out in patients receiving bilateral injections. One eye will be anesthetized using the cryoanesthesia device, developed at the University of Michigan. This has been assessed to be a Non-significant Risk device.
16002231|NCT02872012|Drug|Lidocaine|Lidocaine applied to the non-cryoanesthesia eye.
16002232|NCT02871999|Device|Acupuncture therapy|
16002233|NCT02871999|Procedure|Laparoscopic Surgery|
16002234|NCT02871986|Drug|Routine transdermal oestrogen patch|Transdermal oestrogen patch will be used with an incremental dose increase at 4 months
16002235|NCT02871973|Behavioral|Sit Down and Play|Sit Down and Play (SDP) is designed to be a brief, low-cost intervention that incorporates key theoretical constructs to elicit positive parenting behaviors. It is intended to be delivered by existing clinical staff, nonprofessionals, or volunteers during each of the eight well-child visits between 2-24 months of age while a family waits to be seen by their pediatrician in the examination room.
16002236|NCT02871973|Behavioral|Handout|Handouts developed by Center for Disease Control and Prevention (CDC) to provide information regarding age-specific early childhood milestones
16002237|NCT02871960|Procedure|Robotic and Laparoscopic Colectomy|
16002238|NCT02871934|Genetic|SLCO1B1 Genotype|Polymerase chain reaction (PCR) assay for SLCO1B1 rs4149056, with possible results T/T, T/C, or C/C.
16002239|NCT02871921|Behavioral|Conversational Engagement|Examine whether increasing social interaction through face-to-face (video chat) conversations could improve cognitive function and whether the efficacy is mediated by improved psychological well-being, targeting older adults aged 75 and older who are socially isolated
16002240|NCT02871908|Drug|Lactobacillus reuteri DSM 17938|Lactobacillus reuteri DSM 17938 twice daily 2 x 10^8
16002241|NCT02871908|Drug|Placebo|Placebo
16002242|NCT02871882|Radiation|Gastric Emptying test|participants eat a standardized meal labeled with radioactive markers (99mTc DTPA [diethylenetriaminepentaacetic acid] and In111 Chloride). They have scans taken at specific times after the meal to document the rate of gastric emptying.
16002243|NCT02871882|Other|Mixed Oral Glucose Tolerance test|Participants eat a meal containing 63g glucose in 240mL (milliliters) of skim milk, 2 scrambled eggs, 50g Canadian bacon and one slice of bread. Blood samples are taken prior to and for 6 hours after the meal at specific time points.
16002244|NCT02871882|Drug|Conjugated bile acids sodium|500 mg tablets taken orally twice daily for 28 (+/- 4) days
16002245|NCT02871882|Other|Placebo|Placebo tablets taken orally twice daily for 28 (+/- 4) days
16002246|NCT02871869|Drug|vindesine|3 mg/㎡ (maximum dosage: <4mg), d1, 21 d as a cycle, for 4～6 cycles
16002247|NCT02871869|Drug|cyclophosphamide|750 mg/㎡, d1, 21 d as a cycle, for 4～6 cycles
16002248|NCT02871869|Drug|Epirubicin|60 mg/㎡, d1, 21 d as a cycle, for 4～6 cycles
16002249|NCT02871869|Drug|prednisone tablets|100 mg, d1～5, 21 d as a cycle, for 4～6 cycles
16002250|NCT02871869|Drug|Cinobufacini Tablets|0.3 g per tablet, 3 tablets per time, tid., p.o., until progressive disease or intolerable drug toxicities
16002251|NCT02871869|Drug|Rituximab|375mg/㎡,one day before CHOP protocol
16002252|NCT02871856|Diagnostic Test|Low dose CT|low-dose screening CT of chest for lung cancer detection
16002253|NCT02871843|Drug|RRx-001 dose escalation with TMZ + RT|Dose escalation of RRx-001. Dose levels of 0.5, 1.0, 2.0 and 4.0 mg, once weekly.
16002254|NCT02871843|Radiation|Radiation|Conformal or intensity-modulated radiotherapy (60 Gy in 2 Gy fractions) given 5 days a week for 30 fractions (about 6 weeks)
16002255|NCT02871843|Drug|Fixed dose Temozolomide (75 mg/m2)|Oral temozolomide 75 mg/m2 daily for 6 weeks
16002256|NCT02871843|Drug|TMZ Maintenance|TMZ maintenance at 150-200 mg/m2
16002257|NCT02871830|Behavioral|Physical Activity|15 mins physical activity per day within the school setting.
16002303|NCT02871518|Drug|Cisplatin combine with IMRT|Concurrent cisplatin (100mg/m2，D1,D22) combine with IMRT
16004100|NCT02858271|Drug|AKB-9778 subcutaneous injection|
16002258|NCT02871817|Other|Paxos Checkup Study Mobile Medical Application|The Digisight Paxos Checkup TM is mobile vision assessment system which consists of an application installed on a mobile device with an Internet connection, an Internet Cloud-based vision care network and a web site. The Paxos Checkup app contains a set of quantitative near vision tests, which a patient can take at home or elsewhere using an Internet capable mobile device.
16002259|NCT02871804|Procedure|combined resection of the splenic vein|combined resection of the splenic vein with the pancreatic parenchyma before ligation and division during distal pancreatectomy using mechanical staplers.
16002260|NCT02871804|Procedure|separated resection of the splenic vein|separated resection of the splenic vein from the pancreatic parenchyma before ligation and division during distal pancreatectomy using mechanical staplers.
16002261|NCT02871791|Drug|Palbociclib|
16002262|NCT02871791|Drug|Everolimus|
16002263|NCT02871791|Drug|Exemestane|
16002264|NCT02871778|Drug|VX-371|
16002265|NCT02871778|Drug|Hypertonic Saline|
16002266|NCT02871778|Drug|Placebo (0.17% saline)|
16002267|NCT02871778|Drug|Ivacaftor|
16002268|NCT02871765|Other|Patient education related Warfarin|Patient education related Warfarin: each subject in the experimental group was taught individually according to investigator's brochure in the outpatient department (OPD) by researchers. Three months later, participants received a follow-up phone call in order to clarify any questions related to the brochure. The contents of the brochure consisted of: the purpose of taking Warfarin, side effects, adjustments to daily diet, and precautions (i.e. how to take medication safely, interaction between foods and medicine, prevention and checking of signs and symptoms of bleeding). The control group received the brochure after pretest and routine care only in the OPD. All participants completed posttest at 6-month follow-up.
16002269|NCT02871752|Behavioral|Health promotion|mindfulness-based stress reduction
16002270|NCT02871739|Behavioral|Webinar|1 hour online, interactive webinar that covers shared decision making skills in clinical encounters.
16002271|NCT02871739|Behavioral|DA viewing|Participants will receive 3 decisions aids to review.
16002272|NCT02871739|Behavioral|SPI feedback|Rating of shared decision making skills and opportunities for improvement based on transcript of a standardized patient interaction
16002273|NCT02871726|Device|TRUS-Robot|A robotic device used to hold and manipulate the ultrasound probe during a transrectal prostate biopsy.
16002274|NCT02871726|Other|TRUS biopsy|Uronav for prostate biopsy.
16002275|NCT02871713|Other|Bilateral Quadratus lumborum block with 0.5% ropivacaine|Bilateral Quadratus lumborum block with 0.5% ropivacaine
16002276|NCT02871713|Other|Intrathecal Morphine with 100 mcg morphine|Intrathecal Morphine with 100 mcg morphine
16002277|NCT02871700|Behavioral|Action observation therapy|The patients were asked to observe everyday life actions of which they had motor experience or the actions belong to the motor repertoire of observers', they had better performance. The common categories of motor actions and tasks for stroke patients are selected in this study: (a) active range of motion (AROM) exercises, (b) reaching movement or object manipulation, and (c) upper-extremity (UE) functional tasks practice.
16002278|NCT02871700|Behavioral|Mirror therapy|The MT group will receive 60 minutes of upper-limb training in a mirror box. MT treatment activities will include AROM exercises (10 to 15 minutes), reaching movement or object manipulation (15 to 20 minutes), and functional tasks practice (30 minutes) in a mirror box.
16002279|NCT02871700|Behavioral|Customary bilateral UE training|The participants in this group will receive dose-matched customary bilateral UE training programs for 1 hour per session. The treatment protocol of control group will also include: (a) AROM exercises (10 to 15 minutes), (b) reaching movement or object manipulation (15 to 20 minutes), and (3) functional tasks practice (30 minutes).
16002280|NCT02871687|Drug|Simvastatin|Simvastatin 20 mg daily followed by potential increase to 40 mg simvastatin according to dose escalation procedure
16002281|NCT02871687|Drug|Pravastatin|Pravastatin 40 mg daily followed by potential increase to 80 mg pravastatin according to dose escalation procedure
16002282|NCT02871687|Other|Placebo|Placebo prepared by Investigation Drug Services at Brigham and Women's Hospital
16002283|NCT02871674|Behavioral|Good Night Project|The behavioural interventions have been designed on the basis of three sources. Firstly, a systematic review conducted by the research team that examined the best evidence in the field in different countries. Secondly, a Delphi study, which aimed to identify behavioural interventions that can be used to manage sleep difficulties in Saudi Arabia in accordance with professionals' views and primary caregivers' needs, and which was also conducted by the research team. Thirdly, evidence-based practice resources that help in understanding and managing sleep difficulties will be translated into Arabic.
16002284|NCT02871661|Drug|Amitriptyline|Volunteers will take 25 milligrams of this medication every day from their enrollment until completing eight weeks long.
16002285|NCT02871661|Other|Kinesiotherapy|Volunteers will be taught to contract their pelvic floor muscles right before stretching it, following a home protocol, every day for eight weeks long.
16002286|NCT02871661|Device|IC (Quark)|Volunteers will visit physical therapy clinic once a week to receive twenty minutes of electrical stimulation with Interferential Current (Duapex 961 of Quark Medical manufacturer) in their perineal area, for eight weeks long.
16002287|NCT02871648|Drug|Placebo|Placebo prepared by Investigation Drug Services at Brigham and Women's Hospital
16002288|NCT02871648|Drug|Fludrocortisone|Fludrocortisone 0.1 mg
16002289|NCT02871648|Drug|Eplerenone|Epleronone 100 mg
16002290|NCT02871635|Drug|BI 695501|
16002291|NCT02871635|Drug|HUMIRA|
16002292|NCT02871622|Device|BioMatrix AlphaTM|Cobalt Chromium BA9 TM drug-eluting stent
16002293|NCT02871609|Other|Stent examination, urinary analysis, USSQ questionnaire|
16002294|NCT02871596|Other|Placebo|A combination of maltodextrins and red and blue food colors.
16002295|NCT02871596|Dietary Supplement|Flavonoids|A combination of blueberry extract, black current extract, and black rice extract.
16002296|NCT02871596|Dietary Supplement|Flavonoids+Prebiotics|A combination of blueberry extract, black current extract, black rice extract, inulin, and fructooligosaccharide.
16002297|NCT02871583|Procedure|lichtenstein|tension free mesh hernioplasty (lichtenstein) procedure will be applied for inguinal hernia repair
16002298|NCT02871583|Procedure|Kugel|preperitoneal mesh hernioplasty (Kugel) procedure will be applied for inguinal hernia repair
16002304|NCT02871518|Drug|Cisplatin combine with IMRT|Concurrent cisplatin (100mg/m2，D1,D22 and D43) combine with IMRT
16002305|NCT02871505|Drug|Benzathine Penicillin G|
16002306|NCT02871492|Drug|Pritelivir 5% w/w ointment|
16002307|NCT02871492|Drug|Pritelivir ointment matching placebo|
16002308|NCT02871492|Drug|Zovirax® cream|
16002309|NCT02871479|Drug|SAN007 5% cream|5% EISO in a cream formulation applied twice a day for up to 28 days.
16002310|NCT02871479|Drug|Placebo|A placebo cream containing the same components as the vehicle for the active intervention arm
16002311|NCT02871479|Drug|SAN007 10% cream|10% EISO in a cream formulation applied twice a day for up to 28 days.
16002312|NCT02871466|Drug|stem cells infusion|
16002313|NCT02871453|Device|Scalp Acupuncture Treatment|The Motor Area of the scalp acupuncture is located over the anterior central convolution of the cerebral cortex, being a line starting from a point 0.5cm posterior to the midpoint of the anterior-posterior midline of the head and stretching diagonally to the juncture between the eyebrow-occipital line and the anterior border of the corner of temporal hairline is indistinct, draw a vertical line upward from the middle point of the zygomatic arch to the eyebrow-occipital line, the intersection of the two lines is the projection of the Motor Area. Needles will be inserted in an about 15 degree angle to a depth of 1.0-1.5cm. Needles are rotated at least 200 revolutions per minute for 1 minute every 10 minutes for a total of 60 minutes. five times a week, 8 weeks in total.
16002314|NCT02871453|Other|Rehabilitation treatment|The rehabilitation program was designed according to the Chinese stroke rehabilitation treatment guidelines, which included physical therapy (PT) and occupational therapy (OT). The rehabilitation programs will be carried out five times a week (that is, Monday to Friday) for 8 weeks, and every time the rehabilitation treatment( PT and OT) will last approximately for 1 hour. All rehabilitation treatment will be carried out by qualified therapists.
16002315|NCT02871440|Drug|Omega 3|
16002316|NCT02871440|Drug|Optive Advanced|
16002317|NCT02871440|Drug|Optive|
16002318|NCT02871427|Drug|Nelotanserin|Once Daily, Oral, at 20, 40, 60, or 80 mg dose
16002319|NCT02871414|Behavioral|REST - Early Group|Intervention - 7 weeks of sleep skills education provided in group and one-on-one format
16002320|NCT02871414|Behavioral|REST - Late Group|Control for REST - Early Group, then provided group and one-on-one sleep education and sleep skills intervention
16002321|NCT02871401|Drug|Valganciclovir|Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks.
16002322|NCT02871401|Drug|Placebo|Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks.
16002323|NCT02871388|Behavioral|CONECT|1 monthly in person + 1 monthly telephone + 4 monthly email contact for behavior modification. Focus on motivation, self efficacy and information provision.
16002324|NCT02871375|Device|Delefilcon A multifocal contact lenses|Multifocal contact lenses worn in a daily wear, daily disposable modality (new pair of lenses each morning)
16002325|NCT02871375|Device|Habitual multifocal contact lenses|Multifocal contact lenses worn per subject's habitual prescription and habitual daily wear modality
16002326|NCT02871362|Dietary Supplement|IQP-AS-118|Take one a day
16002327|NCT02871362|Dietary Supplement|Placebo|Take one a day
16002328|NCT02871349|Drug|Propranolol|Propanolol will be given on a titration schedule in which participants will begin with small doses (single capsules) of the drug and increase to a larger dosage (divided over 3 capsules) over the course of three weeks. Participants aged 15-24 years will undergo an MRI.
16002329|NCT02871349|Drug|Placebo|Placebo will be given in the form preferred by the participant and on the same schedule as the propanolol regime. Participants aged 15-24 years will undergo an MRI.
16002330|NCT02871349|Device|Magnetic Resonance Imaging (MRI)|An MRI will be performed on participants aged 15-24 years.
16002331|NCT02871336|Other|Data collection|
16002332|NCT02871323|Biological|Durvalumab|Given IV
16002333|NCT02871323|Other|Laboratory Biomarker Analysis|Correlative studies
16002334|NCT02871310|Dietary Supplement|IQP-AS-118|1 tablet in the morning
16002335|NCT02871310|Dietary Supplement|Placebo|1 tablet in the morning
16002336|NCT02871297|Drug|Vortioxetine|Target dose is 10 mg/day, however, the dose can be down- or uptitrated to 5, 15, or 20 mg/day.
16002337|NCT02871297|Drug|Vortioxetine|5, 10, 15 or 20 mg
16002338|NCT02871284|Behavioral|Exercise|
16002339|NCT02871271|Dietary Supplement|IQP-AS-121|
16002340|NCT02871258|Device|The MetaNeb® System|
16002341|NCT02871245|Procedure|Laparoscopic Surgery|
16002342|NCT02871245|Device|Acupuncture treatment|
16002343|NCT02871232|Other|Researched Abuse, Diversion and Addiction-Related Surveillance (RADARS) System of post-marketing surveillance of prescription medication abuse, misuse, and diversion|
16002344|NCT02871219|Drug|Lenalidomide|Given PO
16002345|NCT02871219|Biological|Obinutuzumab|Given IV
16002346|NCT02871206|Biological|Fluad|
16002347|NCT02871206|Biological|Fluzone|
16002348|NCT02871193|Drug|Ropivacaine|ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.5% ropivacaine 20ml
16002349|NCT02871193|Drug|Dexamethasone|ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.5% ropivacaine 20ml and dexamethasone 5 mg
16002350|NCT02871193|Other|saline|ultrasound-guided thoracic paravertebral nerve block (TPVB) with 0.9% saline 20ml
16002351|NCT02871180|Dietary Supplement|Late night snack|The late night snack was one slice of whole meal rye bread containing approximately 20 g of carbohydrate.
16002352|NCT02871180|Other|No late night snack|Patient consumed no nutrients at late night.
16002353|NCT02871167|Procedure|Controlled ovarian hyperstimulation (COH)|"After information and consent, patients are addressed to a reproductive medicine center.
~The COH will be performed according to a standardized protocol between surgery and the start of adjuvant chemotherapy. Follicular growth will be achieved with an antagonist protocol and by using high dose recombinant FSH (r-FSH). The triggering of the final follicular and oocyte maturation will be obtained by a GnRH (Gonadotropin Releasing Hormone) agonist injection in order to minimize the risk of ovarian hyper-stimulation."
16002383|NCT02870920|Other|Best Supportive Care|
16071130|NCT02374567|Drug|Midazolam|
16002354|NCT02871167|Procedure|Oocyte/embryo freezing|Egg or embryo freezing will be performed according to a standardized protocol: slow-freezing process for embryo; vitrification technique for oocytes. Cryopreserved oocytes and embryos will be stored in the biological bank of each reproductive medicine center (min. 10 years).
16002355|NCT02871154|Other|Delaying oocyte pick up beyond 39 hours post hCG|Unlike the traditional less-than 39 hours interval from hCG injection to oocyte pick up, we will extend the interval up to 47 hours
16002356|NCT02871141|Procedure|electroconvulsive therapy|electroconvulsive therapy
16002357|NCT02871141|Drug|Antidepressant|Antidepressant
16002358|NCT02871128|Dietary Supplement|Natureheme-iron|An 12 week double-blinded randomized parallel study with 4 week follow-up period was performed in mild anemia subjects. Consenting eligible subjects were receive 2 capsules per day containing either 1000 mg Fe of similar appearance for 12 weeks. The subjects were required to visit at baseline, every 6 weeks during the intervention period (6 weeks), and at follow-up 4 weeks after treatment had ended. During each study visit, fasting blood samples were collected and anthropometric measurements were performed. Compliance was evaluated using a food diary and monitored with biweekly telephone calls.
16002359|NCT02871128|Dietary Supplement|Placebo|An 12 week double-blinded randomized parallel study with 4 week follow-up period was performed in mild anemia subjects. Consenting eligible subjects were receive 2 capsules per day containing either 1000 mg starch placebo of similar appearance for 12 weeks. The subjects were required to visit at baseline, every 6 weeks during the intervention period (6 weeks), and at follow-up 4 weeks after treatment had ended. During each study visit, fasting blood samples were collected and anthropometric measurements were performed. Compliance was evaluated using a food diary and monitored with biweekly telephone calls.
16002360|NCT02871128|Drug|supplement|An 12 week double-blinded randomized parallel study with 4 week follow-up period was performed in mild anemia subjects. Consenting eligible subjects were receive 1 capsule per day containing either 100 mg Fe of similar appearance for 12 weeks. The subjects were required to visit at baseline, every 6 weeks during the intervention period (6 weeks), and at follow-up 4 weeks after treatment had ended. During each study visit, fasting blood samples were collected and anthropometric measurements were performed. Compliance was evaluated using a food diary and monitored with biweekly telephone calls.
16002361|NCT02871115|Other|Pharmacy Intervention|Patients randomized to the pharmacy intervention (PRIME) will undergo evaluation with a clinical pharmacist at their second or third chemotherapy infusion who will: (1) perform detailed medication reconciliation and obtain allergy and vaccination history; (2) evaluate and document polypharmacy, potentially inappropriate medications, lack of appropriate medications; and (3) document their findings in the medical record and discuss their recommendations the oncology team.
16002362|NCT02871115|Other|Usual Care|Participants receiving usual oncology care will not meet with the pharmacist unless indicated as part of their routine clinical care. Study staff will obtain all patient-reported measures from the patient.
16002363|NCT02871102|Procedure|Recruitment Maneuver with PEEP and Tidal Volume Optimization|A staircase recruitment maneuver will be performed on pressure control ventilation followed by a decremental PEEP trial. During the decremental PEEP trial inspiratory tidal volumes will be varied at each step between 3 ml/kg and 10 ml/kg predicted body weight while recording the continuous pressure and flow tracings from the mechanical ventilator. With each PEEP and tidal volume combination, end expiratory and end-inspiratory plateau pressure and stress index will be assessed. At the completion of the decremental PEEP trial, the patient will be returned to ARDSnet-recommended ventilator settings.
16002364|NCT02871089|Device|Closed-loop system (Florence M or CamAPS FX)|"The automated closed-loop system (FlorenceM) will consist of:
~Sensor augmented Medtronic insulin pump 640G (Medtronic Minimed, CA, USA) incorporating the Medtronic Enlite/Guardian 3 real time CGM and glucose suspend feature.
~An Android smartphone containing the Cambridge model predictive algorithm and communicating wirelessly with the insulin pump using a proprietary translator device.
~The automated closed-loop system (CamAPS FX) will consist of:
~Dana R or RS insulin pump
~Dexcom G6 real-time CGM
~CamAPS FX App on an unlocked android smartphone.
~Rapid acting insulin analogue will be used (insulin aspart, insulin lispro, insulin glulisine or similar or ultra-rapid insulin analogue)."
16002365|NCT02871089|Other|Multiple Daily Injections|"Rapid acting insulin analogue and long acting insulin analogue will be subcutaneously administered using CE-marked insulin pen devices in accordance with the manufacturer's instructions for their intended purposes.
~Participants will be given long acting analogue (insulin glargine, insulin detemir or similar) once or twice daily according to their needs and boluses of rapid acting analogue (insulin aspart, insulin lispro, insulin glulisine or similar or ultra-rapid insulin analogue) when carbohydrates are consumed."
16002366|NCT02871076|Device|Acupuncture|Patients will be randomized to either treatment arm, verum acupuncture or sham placebo acupuncture.
16002367|NCT02871050|Other|Sample Collection|Excess blood sample tubes and/or buccal swabs or saliva will have DNA and RNA extracted and serum and plasma separated out to be stored for future research purposes based on the results of this preliminary research.
16002368|NCT02871037|Drug|PF-05221304|Single or repeated, escalating dose of PF-05221304
16002369|NCT02871037|Other|Placebo|single or repeated dose of placebo
16002370|NCT02871024|Device|Toraymyxin|Toraymyxin is an extracorporeal hemoperfusion device designed to reduce blood endotoxin levels in sepsis
16002371|NCT02871011|Drug|Nitric Oxide|Delivered as a footbath
16002372|NCT02871011|Drug|Water|Delivered as a footbath
16002373|NCT02870998|Other|Active learning|1-day continuing education activity consisting of a lecture on patient education.
16002374|NCT02870998|Other|Passive learning|1-day continuing education activity consisting of a brief lecture on patient education and workshops.
16002375|NCT02870985|Device|Coronary Stent|
16002376|NCT02870972|Drug|BCX7353|Plasma kallikrein inhibitor
16002377|NCT02870972|Drug|Placebo|
16002378|NCT02870946|Procedure|Simultaneous RRT|The patients in the simultaneous RRT arm will receive RRT when ECMO is commenced. (see Study Description)
16002379|NCT02870946|Procedure|Standard care|The patients in the standard care arm will not receive RRT when ECMO is commenced. Only when a patient demonstrates AKI and fulfills any one of the criteria of the conventional RRT indication, RRT would be delivered.
16002380|NCT02870933|Biological|Transepicardial with Transseptal CD 133+ Implantation|Transepicardial with Transseptal CD 133+ Implantation
16002381|NCT02870920|Drug|Tremelimumab|
16002382|NCT02870920|Drug|Durvalumab|
16002385|NCT02870907|Drug|Etoposide|100 mg/m²/d, IV (in the vein) from D1 to D5.
16002386|NCT02870907|Drug|Vincristine|1, 5 mg/m²/d, IV at D1.
16002387|NCT02870907|Radiation|Orbital irradiation|45 Grays (Standard or external beam radiotherapy).
16002388|NCT02870907|Drug|Carboplatin|160 mg/m²/d, IV from D1 to D5.
16002389|NCT02870907|Drug|Vincristine|1,5 mg/m²/d, IV at D22 and D26
16002390|NCT02870907|Drug|Cyclophosphamide|300 mg/m²/d, IV from D22 to D26.
16002391|NCT02870907|Drug|Carboplatin|560 mg/m²/d, IV at D1.
16002392|NCT02870907|Drug|Etoposide|100 mg/m²/d, IV from D1 to D5
16002393|NCT02870907|Drug|Carboplatin|160 mg/m²/d,IV from D1 to D5
16002394|NCT02870907|Drug|Thiotepa|15 mg, intrathecal Thiotepa injection at D1.
16002395|NCT02870907|Drug|Vincristine|1,5 mg/m²/d), IV at D22
16002396|NCT02870907|Drug|Cyclophosphamide|1000 mg/m²/d, IV from D22 à D24.
16002397|NCT02870907|Procedure|Cytapheresis|Cytapheresis for peripheral blood stem cells collection after the primary or the secondary courses of Vincristine- Cyclophosphamid.
16002398|NCT02870907|Drug|Carboplatin|AUC : 7/d, IV from D-8 to D-6.
16002399|NCT02870907|Drug|Etoposide|250 mg/m²/d, IV from D -5 to D-3.
16002400|NCT02870907|Drug|Thiotepa|300 mg/m²/d, IV from D-5 to D-3.
16002401|NCT02870907|Procedure|Peripheral bood stem cell transplantation|at D0
16002402|NCT02870868|Behavioral|Slow breathing|Slow breathing techniques from yoga
16002403|NCT02870855|Drug|intrauterine injection of HCG|intrauterine injection of HCG berore blastocyst transfer
16002404|NCT02870842|Device|Lung ultrasound|Lung ultrasound on both hemithorax in supine position
16002405|NCT02870842|Other|Respiratory management|Appropriate respiratory managements depending on the lung ultrasound findings
16002406|NCT02870829|Drug|menaquinone-7|Oral supplement given post dialysis 3x/week
16002407|NCT02870816|Procedure|Tissue Engineered Skin Substitute|Application of skin substitute and non-adherent dressing, a moisture retentive dressing, and a multi-layer compression dressing.
16002408|NCT02870816|Device|Offloading|"Provision of offloading cast walker or similar sponsor-approved device. May convert into instant total contact cast and/or add felt/foam to supplement offloading."
16002409|NCT02870816|Procedure|Amnionic Membrane Graft|Application of amnion membrane graft and non-adherent dressing, a moisture retentive dressing, and a multi-layer compression dressing.
16002410|NCT02870790|Drug|TDF/FTC|one pill daily
16002411|NCT02870777|Combination Product|MRD-directed therapy|The purpose of this study is to establish risk stratification based on cytogenetics at diagnosis and MRD analysis after induction chemotherapy and before consolidation chemotherapy to determine whether a MRD directed therapy for low and intermediate AML patients has positive results in terms of overall survival.
16002412|NCT02870764|Drug|Dan-shen extract|A kind of injection made from a kind of Chinese herb: salvia miltiorrhiza
16002413|NCT02870764|Drug|Placebo|200mg glugose added into 250ml 0.9% saline injection by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion.
16002414|NCT02870764|Other|Standard medical care|Standard medical care is in accordance with China Guideline for the diagnosis and treatment of Chronic Stable Angina (2007).
16002415|NCT02870751|Biological|TW11681 or TW10722|
16002416|NCT02870738|Procedure|Pelvic Floor Physical Therapy|Internal and/or external myofascial release of the pelvic floor muscles
16002417|NCT02870738|Drug|Bladder Instillations|A solution of heparin sulphate 40,000 IU (4 cc of 10,000 units/cc), lidocaine 2% 16 ml, Sodium bicarbonate 8.4% 4 ml and Kenalog 40 mg (1cc) to reach a total fluid volume of 25 ml will be instilled into the bladder with a urinary catheter
16002418|NCT02870725|Behavioral|CBT Individual Psychotherapy|The 4-session CBT treatment will include receipt of a manualized cognitive behavioral intervention, delivered individually, to treat the depression symptoms (e.g. cognitive restructuring, behavioral activation) and teach adaptive coping strategies to manage their depression. Ideally, the intervention will also positively affect their chronic headaches (i.e. reduction of headache frequency, severity and level of disability). Each session is approximately 60 minutes with specific, reflective and guided activities related to a specific module within the intervention.
16002419|NCT02870712|Procedure|Suture of perineum|suture of the tear to obtain hemostasis
16002420|NCT02870712|Procedure|hemostatis by digital compression|Digital compression of the tear to obtain hemostasis
16002421|NCT02870699|Device|Evonail|film-forming solution containing water Evaux naturally rich in lithium, strontium and manganese with UV filter
16002422|NCT02870699|Device|Placebo excipient|film forming excipient solution
16002423|NCT02870686|Procedure|ERCP without the use of fluoroscopy|ERCP removal of stone technique without the use of fluoroscopy involves: (1) catheter with wire achieve bile duct, (2) confirmation of bile duct achievement with catheter aspiration of bile, (3) performance of endoscopic biliary sphinctertome, (4) stone removal with balloon or basket- number of stones removed should compare number detected on EUS, (5) confirmation of complete stone clearance with radiocontrast.
16002424|NCT02870686|Procedure|ERCP with the use of fluoroscopy|ERCP removal of stone technique with the use of fluoroscopy involves: (1) catheter with wire achieve bile duct, (2) confirmation of bile duct achievement with fluoroscopy images, (3) performance of endoscopic biliary sphinctertome, (4) stone removal with balloon or basket, (5) confirmation of complete stone clearance with radiocontrast.
16002425|NCT02870673|Drug|SHINCORT|triamcinolone Acetonide (10mg/ml) 0.5 ml
16002426|NCT02870673|Drug|XYLOCAINE|xylocaine(20mg/ml) 0.5 ml
16002427|NCT02870673|Device|sham electroacupuncture|1.5 inches 32 gauze stainless steel needles Transcutaneous electrical nerve stimulation machine (MODEL-05B(6))
16002428|NCT02870673|Device|electroacupuncture|1.5 inches 32 gauze stainless steel needles Transcutaneous electrical nerve stimulation machine (MODEL-05B(6))
16002429|NCT02870660|Other|Registry|
16002430|NCT02870647|Other|Echocardiographic, polygraphy, electrocardiography measurements and sleep questionnaire|each patient is asked to undergo an echocardiographic, polygraphy, electrocardiography measurements, and respond to 2 sleep questionnaires, both at inclusion and after 6 months
16002431|NCT02870634|Drug|Cu(II)ATSM|copper-containing synthetic small molecule
16002432|NCT02870608|Other|lung and liver elastography measurement of fetus|
16071131|NCT02374567|Drug|Brotizolam|
16002433|NCT02870595|Device|Microvibratory Stimulator|Informed consent will be obtained from patients undergoing finger local anesthesia digit blocks. Subjects will be randomly assigned (using GraphPAD Randomization Software Tool) to receive the first of their two digit block injections with either the traditional technique (control) or while using the DVICS/ Microvibratory Stimulator. All injections will utilize a 27-gauge needle. The subjects will be given a standard dose of 2mls of 1% lidocaine without epinephrine delivered over 30 seconds. Injections will be timed and performed by a single clinician to avoid large variations in technique and expertise.
16002434|NCT02870595|Device|Microvibratory Stimulator'|As above, Microvibratory Stimulator will be used as a sham device in parallel group.
16002435|NCT02870582|Drug|Donafenib|treatment drug
16002436|NCT02870582|Drug|Placebo|Best support treatment
16002437|NCT02870569|Drug|Donafenib 200mg|Donafenib is an oral multikinase inhibitor with antiproliferative and antiangiogenic effects.The arm is the lower dose one.
16002438|NCT02870569|Drug|Donafenib 300mg|Donafenib is an oral multikinase inhibitor with antiproliferative and antiangiogenic effects.The arm is the higher dose one.
16002439|NCT02870556|Device|cervical epidural analgesia|
16002440|NCT02870543|Drug|Phytolacca decandra|Treatment of bruxism
16002441|NCT02870543|Drug|Melissa officinalis|Treatment of bruxism
16002442|NCT02870543|Drug|Phyt.decandra + Melissa offic.|Treatment of bruxism
16002443|NCT02870530|Procedure|division-less gastric bypass|in division-less gastric bypass, the investigators will do the gastric bypass without division of the stomach into 2 part (pouch part and the rest of the stomach that still connected to the duodenum) but the pouch which will anatomised with the small intestine is excluded from within, in comparison to standard mini-gastric bypass so that we try to decrease the cost of stapler and its complication
16002444|NCT02870530|Procedure|mini-gastric bypass|classic laparoscopic mini-gastric bypass as described by Rutledge
16002445|NCT02870517|Other|Relaxing Music|Relaxing music, will be played through noise-cancelling headphones during induction of anesthesia. All of the songs used in this study will have <60 BPM, be instrumental rather than lyrical, and utilize predictable chord progressions. Music will be divided into several themed playlists which will be focused on the type of instruments involved including guitar, steel drum, and piano. The patient will listen to the music through noise-cancelling headphones beginning fifteen minutes prior to induction and ending one minute after intubation.
16002446|NCT02870517|Other|No Music|The patient will wear noise-cancelling headphones beginning fifteen minutes prior to induction and ending one minute after intubation.
16002447|NCT02870504|Procedure|Corneoscleral limbus group|Laser spot locates on the corneoscleral limbus
16002448|NCT02870504|Procedure|one spot group|Laser spot locates on one spot away from the corneoscleral limbus
16002449|NCT02870504|Procedure|two spots group|Laser spot locates on two spots away from the corneoscleral limbus
16002450|NCT02870491|Behavioral|Free Distribution|Caretakers of children under 5-years-old will have access to free ORS and zinc
16002451|NCT02870491|Behavioral|Preemptive Delivery|Caretakers of children under 5-years-old will have ORS and zinc delivered to their home
16002452|NCT02870478|Drug|Atropine|Dosing frequency comparison, using atropine sulfate 1% solution diluted to 0.01% and 0.05% by Leiter's Compounding Pharmacy
16002453|NCT02870465|Procedure|Closed Reduction Internal Fixation|K-wires placed percutaneously through the skin to achieve fixation of a hand after reduction of the fracture in a closed manner.
16002454|NCT02870452|Behavioral|Hypnosis|4 weekly individual sessions of Hypnosis, conducted by a certified psychologist, with the approximate duration of 90 minutes.
16002455|NCT02870452|Behavioral|Cognitive-Behavioral Therapy|4 weekly individual sessions of CBT, conducted by a certified psychologist, with the approximate duration of 90 minutes.
16002456|NCT02870439|Other|Blood drawn|
16002457|NCT02870426|Procedure|Frontal Craniotomy and retrieval of OBs|For Group 1A the craniotomy will occur during organ retrieval for transplantation under aseptic technique. For Group 1B it would occur as a separate surgical procedure prior to palliation under full asepsis.
16002458|NCT02870426|Procedure|OB Retrieval During Anterior Cranial Surgery|Group 2: The patients routine anterior cranial surgery would proceed as planned without change to the surgical procedure. In the event that the ON had to be sacrificed for the purposes of surgery the OB of the concomitant nerve would be retrieved.
16002459|NCT02870413|Behavioral|Telelactation services|Mothers will get unlimited access (for a three month period) to video calls with lactation consultants who are available 24/7. Mothers can use the service as demanded.
16002460|NCT02870400|Drug|REGN2477|Participants will receive ascending doses of REGN2477
16002461|NCT02870400|Drug|Placebo|Participants will receive matching placebo
16002462|NCT02870387|Other|Comprehensive Care with Inpatient consultation|Comprehensive care with Inpatient Consultation: HRCC patients randomized to the comprehensive care with inpatient consultation group that are admitted to CMHH will receive inpatient consultation by HRCC providers during their stay with input and recommendations conveyed to the hospital inpatient team on admission and at discharge at a minimum (in person consultations on weekdays and phone consultations on the weekends). The HRCC providers will review the inpatient care plan and will make treatment and discharge recommendations with a focus on coordination and integration of inpatient and outpatient care. Ideally, the inpatient consultations are face-to-face meetings with the hospital inpatient team but could also be a phone call or a consult note written in the medical record.
16002463|NCT02870387|Other|Usual Inpatient Care|High-Risk Children's Clinic (HRCC) patients randomized to the usual inpatient care group who are admitted to Children's Memorial Hermann Hospital (CMHH) will receive usual inpatient care from the primary hospital admitting team (residents and fellows supervised by pediatric faculty physicians) with usual occasional communication with the patient's assigned HRCC provider. HRCC patients admitted to CMHH in this treatment group will receive usual inpatient care that is not modified by the study protocol.
16002464|NCT02870374|Behavioral|Answering specific quality of life questionnaire in kidneys transplantation population|
16002465|NCT02870361|Drug|intranasal insulin|
16002466|NCT02870361|Drug|Placebo|
16002467|NCT02870348|Biological|Alpha-1 MP|Weekly intravenous infusions of 60 mg/kg Alpha-1 MP
16002516|NCT02870010|Biological|blood samples (5 ml) will be taken|blood samples (5 ml) will be taken
16002702|NCT02868775|Procedure|cystoscopy, bladder hydrodistention and bladder biopsy|
16002468|NCT02870335|Other|Manual Therapy|The patient remained lying on the gurney and the treatment was performed in the order set forth below and included: overall bilateral manipulation of L5-S1-Sacroiliac, subsequently decompression hip joint, the tibiofemoral decompression, stretching rotators hip flexion or hip and knee mobilization technique downing head and base of the fibula, tibiofibular-talus tali posteriorización decompression and with the help of a wedge to facilitate technical.
16002469|NCT02870335|Other|Proprioceptive neuromuscular facilitation|Stretching were conducted in the hamstrings, psoas, adductors, pyramidal, quadriceps and right above.
16002470|NCT02870322|Behavioral|Fruit and Vegetable CSA Prescription|Study Participants will collect and use fruit and vegetable CSA boxes given to them weekly for 10 weeks.
16002471|NCT02870322|Behavioral|Bikeshare Prescription|Study participants will use bikeshare for transportation and physical activity for 10 weeks
16002473|NCT02870296|Behavioral|Enhanced Assessment and Education|Patients in the Intervention Group will: 1) have an in-home pharmacist medication assessment; 2) receive enhanced medication instructions (including pictograms); 3) receive an additional individualized assessment and educational session with a clinician provider related to the medication management for their disease (VTE).
16002474|NCT02870283|Drug|Lithium|
16002475|NCT02870283|Drug|Valproic Acid|
16002476|NCT02870283|Drug|Carbamazepine|
16002477|NCT02870270|Other|Cancer treatment|Patients undergoing treatment for cancer in the head and neck region
16002478|NCT02870257|Other|Strengthening protocol with progressive load|Strengthening protocol for scapular and shoulder muscles
16002479|NCT02870257|Other|Strengthening protocol without progressive load|Strengthening protocol for scapular and shoulder muscles
16002480|NCT02870244|Biological|Escalating Doses|"Subjects will receive a single infusion of autologous bulk TIL 13831 TCR transduced T cells supported with low dose IL-2. Autologous bulk TIL 13831 TCR transduced T cells means the infusion will consist of a polyclonal mixture of CD4 + and CD8+ T Cells expressing the TIL 13831 TCR.
~Subjects in Cohort 1 will receive 7.5 x 10^6/kg TIL 1383I TCR transduced T cells.
~Subjects in Cohort 2 will receive 2.5 x 10^7/kg TIL 1383I TCR transduced T cells.
~Subjects in Cohort 3 will receive 7.5 x 10^7/kg TIL 1383I TCR transduced T cells."
16002481|NCT02870231|Drug|NNC9204-0530|Once-daily subcutaneous (s.c., under the skin) administration.
16002482|NCT02870231|Drug|liraglutide|Once-daily subcutaneous (s.c., under the skin) administration.
16002483|NCT02870231|Drug|placebo|Once-daily subcutaneous (s.c., under the skin) administration
16002484|NCT02870218|Drug|Smoking research cigarettes with e-cigarette|Smoking research cigarettes with varying levels of nicotine with unlimited access to 15 mg/ml nicotine-containing e-cigarettes.
16002485|NCT02870218|Drug|Nicotine discrimination thresholds|Measure of nicotine thresholds for detecting and recognizing the addictive, rewarding effects of smoking.
16002486|NCT02870205|Drug|GSP 301 NS|2 spray in each nostril twice daily for 14 days
16002487|NCT02870205|Drug|GOM-NS|2 spray in each nostril twice daily for 14 days
16002488|NCT02870205|Drug|GMM-2 NS|2 spray in each nostril twice daily for 14 days
16002489|NCT02870205|Drug|GSP 301 placebo NS|2 spray in each nostril twice daily for 14 days
16002490|NCT02870192|Procedure|Laparoscopic ventral mesh rectopexy|Laparoscopic opening of the Daglous pouch, dissection till reach the levator ani muscle, mesh implementation and fixation, closure of the daglous. The mesh implemented may be synthetic or biological mesh.
16002491|NCT02870179|Device|Pulse Oximeter|Measurement of physiological parameters
16002492|NCT02870166|Other|blood sample|
16002493|NCT02870153|Drug|SOX|Oxaliplatin 130mg/m2 IV on D1 every 21 days and S-1 80mg/m2/day PO [BSA <1.25 40mg bid (total 80mg/day); BSA ≥1.25 - <1.5 50mg bid (total 100mg/day); BSA ≥1.5 60mg bid (total 120mg/day)], divided by two on D1-14 every 21 days
16002494|NCT02870153|Drug|XELOX|Oxaliplatin 130mg/m2 IV on D1 every 21 days and Capecitabine 2000mg/m2/day PO, divided by two on D1-14 every 21 days
16002495|NCT02870140|Device|SUPRAFLEX|Percutaneous Coronary Intervention
16002496|NCT02870140|Device|XIENCE|Percutaneous Coronary Intervention
16002497|NCT02870127|Other|blood sample|
16002498|NCT02870101|Diagnostic Test|Nucleic acid amplification test 1 for NG and CT|A combination test using real-time PCR to detect DNA from NG and CT.
16002499|NCT02870101|Diagnostic Test|Nucleic acid amplification test 2 for NG and CT|A combination test using target amplification to detect RNA from NG and CT.
16002500|NCT02870101|Diagnostic Test|Nucleic acid amplification test 3 for NG and CT|A combination test using real-time PCR to detect DNA from NG and CT.
16002501|NCT02870088|Behavioral|Prolonged Sitting|After consuming 1st meal, participants sat on a chair for 180 min. After 180 min, the 2nd meal was provided. After finishing the 2nd meal, participants sat on a chair for another 120 min.
16002502|NCT02870088|Behavioral|Breaking Sitting|After consuming 1st meal, participants walked 2 min on a treadmill every 20 minutes for the following 180 min. For the remainder of the time participants sat on the chair. After 180 min, the 2nd meal was provided. After finishing the 2nd meal, participants continued 2 min of walking every 20 min for the following 120 min.
16002503|NCT02870075|Behavioral|Fed exercise|Participants consumed a meal (Fed) 2 h prior to 1 h moderate intensity exercise at 60% VO2max.
16002504|NCT02870075|Behavioral|Fasted exercise|Participants remained fasting (Fasted) 2 h prior to 1 h moderate intensity exercise at 60% VO2max.
16002505|NCT02870062|Other|Daily baths with chlorhexidine wipes, oral spray and standard shampoo|Description already mentioned in arm/group descriptions.
16002506|NCT02870062|Other|Daily baths with placebo wipes, oral spray and shampoo|Description already mentioned in arm/group descriptions.
16002507|NCT02870049|Behavioral|Inreach strategy|Inreach strategy: In clinic education and delivery of fecal immunochemical test (FIT) kit
16002508|NCT02870049|Behavioral|Outreach strategy|Outreach strategy: Mailed fecal immunochemical test (FIT) kit and telephone reminders
16002509|NCT02870049|Behavioral|Both Inreach and Outreach strategies|Both Inreach and Outreach strategies: Both In clinic education and delivery of fecal immunochemical test (FIT) kit and Mailed fecal immunochemical test (FIT) kit and telephone reminders
16002510|NCT02870049|Behavioral|Usual care|Usual care: FIT kit delivery as part of usual care
16002511|NCT02870036|Drug|Simmitecan|
16002517|NCT02870010|Radiation|Chemoembolization|Chemoembolization will take place in the Interventional Radiology room: the syringe, prepared at the pharmacy, will contain microspheres loaded with a defined dose of idarubicin. Then five millilitres of Visipaque® will be added to visualize the injection
16002518|NCT02869997|Device|Aspect BIS XP (A-2000) Bispectral Index Patient Monitor|
16002519|NCT02869984|Drug|Ramosetron|
16002520|NCT02869971|Device|Embosphere® (Prostatic Arteries Embolization)|Prostatic Arteries Embolization with 300-500 µm trisacryl microspheres
16002521|NCT02869971|Drug|Drug therapy|Combodart (dutasteride 0.5 mg/tamsulosin 0.4 mg)
16002522|NCT02869958|Other|Digital action plan for asthma exacerbations + Written action plan|Digital action plan for asthma exacerbation available through an AppWeb and requiring a connected device such as a Smartphone or a tablet computer. The patient must connect and describe the situation to obtain the names, doses and dosing of the treatment his/her physician has recommended for him/her according to the level of severity of the exacerbation
16002523|NCT02869958|Other|Written action plan|
16002524|NCT02869945|Genetic|Identification of COMT HH, COMT HL or COMT LL genes|COMT HH, COMT HL or COMT LL genes identification
16002525|NCT02869945|Other|Brain MRI with resting state scan|MRI scan with resting state study to be performed to assess the compensation mechanisms at the networks level.
16002526|NCT02869945|Other|Brain MPET|Monophotonic emission tomography with I-123-Ioflupane to assess the level of dopaminergic denervation.
16002527|NCT02869932|Radiation|Lung CT scan|Lung CT scan without injection
16002528|NCT02869919|Other|AKI|Vitamin D levels
16002529|NCT02869906|Other|FFR and iFR|The investigators aimed to assess the reliability of the instantaneous wave-free ratio (iFR) and fractional flow reserve (FFR) measurements in non-culprit coronary lesions during the acute and subacute phase of ST-segment elevation myocardial infarction (STEMI).
16002530|NCT02869893|Drug|Secretin|
16002531|NCT02869880|Other|Enhanced Pre-Consent Discussion|The enhanced pre-consent discussion intervention is a tool that includes both textual and graphical information regarding the trial and an interactive component designed to initiate and facilitate conversations between all parties in the decision-parent, patient, healthcare provider and research staff.
16002532|NCT02869880|Other|Standard Pre-consent Discussion|Standard pre-consent discussion for a clinical trial
16002533|NCT02869867|Other|refrigerated cushion|refrigerated cushion
16002534|NCT02869854|Behavioral|Mindfulness|Mindfulness course during 8 weeks with 20 minutes mindfulness exercise each day
16002535|NCT02869854|Behavioral|PAP|Physical Activity on Prescription, after 3 months a new prescription
16002536|NCT02869841|Drug|Levobupivacaine continuous infusion|Levobupivacaine continuous infusion to rectus sheath catheters
16002537|NCT02869841|Drug|levobupivacaine bolus dosing|Levobupivacaine bolus dosing to rectus sheath catheters
16002538|NCT02869841|Drug|single bolus of levobupivacaine|Levobupivacaine single dose to rectus sheath catheters
16002539|NCT02869841|Other|Placebo|No rectus sheath analgesia
16002540|NCT02869828|Device|Monitoring by arterial catheter and Spot-on|
16002541|NCT02869828|Device|Monitoring by oesophagal probe and Spot-on|
16002542|NCT02869815|Procedure|ICG+Methylene Blue|"ICG+Methylene Blue Arm:
~One ml of methylene blue (1%) would be in injected sub-areolarly 5 minutes before surgery, and 1ml of ICG (0.125%) in the same site 3 minutes later. Massage of the breast would be applied to facilitate the movement of the tracers. A small incision would be made in the axilla, and a special device would be used to search the light nodes. During the sampling, blue nodes would also be resected . After the completion of SLNB, complete axillary dissection would be carried out."
16002543|NCT02869802|Procedure|Tumour Biopsy|If there is the presence of a tumour lesion amenable to core needle biopsy as judged by a staff interventional radiologist, a minimum of 3 tumour cores will be obtained under CT or US guidance.
16002544|NCT02869802|Other|Serial Collection of Plasma and Serum Samples|Participants will undergo serial collection of plasma and serum samples at baseline and every 4 weeks until end of study.
16002545|NCT02869789|Drug|Nivolumab in combination with Ipilimumab|Specified dose on specified days
16002546|NCT02869776|Behavioral|Questionnaire|Behavioral questionnaires
16002547|NCT02869776|Procedure|Rapid finger stick|HIV and HCV testing through rapid finger stick
16002548|NCT02869776|Procedure|Venipuncture|HIV and HCV testing through venipuncture
16002549|NCT02869763|Dietary Supplement|10 g ethanol|"31 mL of Vodka Absolut® diluted in 369 mL of lemon flavored-water (LFW) Fontvella®.
~A total volume of 400 mL of the drink will be administered, distributed in three 133 mL cool glasses. Administration of ethanol beverage will be controlled: participants will have 5 minutes to drink each glass."
16002550|NCT02869763|Dietary Supplement|20 g ethanol|"63 mL of Vodka Absolut® diluted in 337 mL of lemon flavored-water (LFW) Fontvella®.
~A total volume of 400 mL of the drink will be administered, distributed in three 133 mL cool glasses. Administration of ethanol beverage will be controlled: participants will have 5 minutes to drink each glass."
16002551|NCT02869763|Dietary Supplement|Water|400 mL of lemon flavored-water Fontvella®. A total volume of 400 mL of the drink will be administered, distributed in three 133 mL cool glasses. The administration will be controlled: participants will have 5 minutes to drink each glass.
16002552|NCT02869737|Device|Coagucheck, Roche, France|Capillary puncture for POC INR measurement
16002553|NCT02869724|Other|Weekly divided delivery|
16002554|NCT02869724|Other|Monthly divided delivery|
16002555|NCT02869711|Other|Health care quality management|
16002556|NCT02869698|Procedure|Spectral Dynamic Imaging|
16002557|NCT02869698|Device|Hybride electrode|
16002558|NCT02869698|Device|Macro electrode|
16002559|NCT02869685|Radiation|radiotherapy|
16002560|NCT02869672|Biological|Tiantan Biology ACYW135 meningococcal polysaccharide vaccine|Tiantan Biology ACYW135 meningococcal polysaccharide vaccine, intramuscular injection, 0.5 ml
16002561|NCT02869672|Biological|Hualan Biology ACYW135 meningococcal polysaccharide vaccine|Hualan Biology ACYW135 meningococcal polysaccharide vaccine, intramuscular injection, 0.5 ml
16002562|NCT02869659|Behavioral|Weight Loss Group|All participants will follow the Medifast Achieve TM 4 & 2 & 1 Plan® which includes the 4 MR products per day, with the addition of 2 Lean and Green™ Meals and 1 Healthy Snack
16002700|NCT02868801|Drug|Pregabalin SR tablet 660mg/day|According to the efficacy and safety in titration.
16002563|NCT02869659|Behavioral|Delayed Weight Loss|18 weekly, group dietary and exercise sessions led by the study staff in which participants will follow a modified Diabetes Prevention Program
16002566|NCT02869633|Drug|Ibrutinib|Given by mouth
16002567|NCT02869633|Other|Laboratory Biomarker Analysis|Correlative studies
16002568|NCT02869620|Other|Data collection|
16002569|NCT02869607|Other|Data collection|
16002570|NCT02869594|Other|Data collection|
16002571|NCT02869581|Other|Data collection|
16002572|NCT02869568|Other|Data collection|
16002573|NCT02869555|Other|Data collection|
16002574|NCT02869542|Other|Data collection|
16002575|NCT02869529|Other|Data collection|
16002576|NCT02869516|Other|Clinical data collection|
16002577|NCT02869503|Other|Data collection|
16002578|NCT02869490|Other|Data collection|
16002579|NCT02869477|Other|Data collection|
16002580|NCT02869464|Other|Imaging-Ultrasound|Abdominal Ultrasound
16002581|NCT02869464|Other|Imaging-MRA|Non-contrast Enhanced Magnetic Resonance Angiogram
16002582|NCT02869464|Genetic|DNA, RNA testing|To test for the co-prevalence of shared genetic markers in afflicted populations.
16002583|NCT02869451|Drug|bupropion|Prescribed one week prior to quit and continued until the 6 month follow-up visit.
16002584|NCT02869451|Drug|transdermal nicotine patch|Initiated at smoking quit date; 7 mg to 21 mg patch depending on amount smoked by participant
16002585|NCT02869451|Drug|Nicotine polacrilex|Initiated at smoking quit date.
16002586|NCT02869451|Drug|nicotine lozenge|Initiated at smoking quit date.
16002587|NCT02869451|Behavioral|counseling for marijuana and smoking cessation|5 sessions of cognitive-behavioral counseling designed to facilitate marijuana and smoking cessation and promote relapse prevention
16002588|NCT02869451|Behavioral|mobile contingency management|treatment that provides money rewards for abstinence from smoking and marijuana
16002589|NCT02869438|Drug|Benralizumab|Benralizumab administered subcutaneously at Visit 1 (Day 0), Visit 8 (Day28 +/- 3 days) and Visit 9 (Day 56 +/- 3 days)
16002590|NCT02869438|Other|Placebo|Placebo administered subcutaneously at Visit 1 (Day 0), Visit 8 (Day28 +/- 3 days) and Visit 9 (Day 56 +/- 3 days)
16002591|NCT02869425|Drug|arbaclofen ER Tablets|arbaclofen ER tablets, 10 mg, 15 mg, or 20 mg
16002592|NCT02869425|Drug|Placebo for arbaclofen ER tablets|matching placebo tablets to arbaclofen ER tablets 10 mg, 15 mg or 20 mg
16002593|NCT02869412|Other|Computer-Assisted Intervention|Use BCG website
16002594|NCT02869412|Other|Computer-Assisted Intervention|Use passive website
16002595|NCT02869412|Other|Quality-of-Life Assessment|Ancillary studies
16002596|NCT02869412|Other|Questionnaire Administration|Ancillary studies
16002597|NCT02869399|Dietary Supplement|dietary intervention in addition to standard recommendations|"The diet of the intervention group will be based on the AICR/WCRF recommendations for cancer prevention and for the prevention of recurrences (www.dietandcancerreport.org):
~avoid or limit alcoholic drinks (2 drinks men, 1 drink women)
~increase consumption of a variety of non-starchy vegetables, fruits (at least 400g per day) and dietary fibers (at least 25g per day)
~eat mostly food of plant origin
~eat lean meat, limit intake of red meat and avoid processed meat
~increase consumption of anti-inflammatory foods, such as fish and whole grain cereals, f.e. brown rice and barley creams
~avoid high glycaemic and high insulinemic foods, such as refined flours, white breads, and pastries"
16002598|NCT02869386|Procedure|STEMO|STEMO, the intervention, includes prehospital neurological emergency assessment with the option to perform CT and CT-angiography, start specialized treatment at the door-step of the patient's house, including thrombolysis with tissue Plasminogen Activator and blood pressure Management (choice of drug at discretion of treating physician), use telemedicine for further expertise as well as results of point-of-care laboratory, prenotification (e.g. for endovascular treatment), triage and transport.
16002599|NCT02869386|Procedure|Regular care|A regular ambulance, the comparator intervention, not equipped with advanced point-of-care laboratory or CT scanner, without telemedicine and not staffed with a neurologist.
16002600|NCT02869373|Behavioral|spinal stabilizaton exercise|In Exercise group, spinal stabilization exercise program was carried out 3 days a week for 8 weeks.
16002601|NCT02869347|Drug|Conestat alfa|Two intravenous injections (over 5 minutes) of Conestat alfa immediately pre-procedure (elective coronary angiography) and 4 hours later; for patients less than 84kg at a dose of 50 U/kg, and for patients of 84kg body weight or greater at a dose of 4200 U.
16002602|NCT02869347|Drug|Sodium chloride 0.9%|Two intravenous injections of sodium chloride 0.9% (maximum 28 ml, matching the respective amount of the Conestat alfa arm) immediately pre-procedure (elective coronary angiography) and 4 hours later.
16002603|NCT02869334|Device|Active Transcranial direct current stimulation (tDCS)|Active tDCS, where an extremely weak electric current passes through the brain
16002604|NCT02869334|Device|Sham Transcranial direct current stimulation (tDCS)|Sham (inactive or placebo) tDCS
16002605|NCT02869334|Behavioral|Auditory Remediation|Computer program designed to improve discrimination between sounds
16002606|NCT02869334|Behavioral|Control computer activities|Computer program (e.g. games), which are not designed to improve discrimination between sounds
16002607|NCT02869321|Drug|Fentanyl|
16002608|NCT02869321|Drug|Morphine Sulfate|
16002609|NCT02869321|Drug|Fentanyl placebo|
16002610|NCT02869321|Drug|Morphine Sulfate placebo|
16002611|NCT02869321|Procedure|Gastrostomy|
16002612|NCT02869308|Drug|stannous pyrophosphate|Injection of 1ml Angiocis
16002613|NCT02869308|Drug|Technetium-99m|Injection of 900 MBq Technetium-99m, 30 min after Angiocis injection
16002614|NCT02869308|Device|E-CAM Camera|Acquisition of images of angioscintigraphy with E-CAM camera, after injection of Angiocis and Technetium-99m
16002615|NCT02869308|Device|CZT Semiconductor Camera (D-SPECT)|Acquisition of images of angioscintigraphy with D-SPECT camera
16002616|NCT02869295|Drug|NKTR-214|Participants in the dose escalation cohorts will be treated every 21 days (q21d) or every 14 days (q14d) until tumor progression.
16002617|NCT02869282|Other|Blood samples|Additional blood samples at baseline, 6, 12, 18 and 24 months.
16002618|NCT02869282|Other|Urine samples|Additional urine samples at baseline, 6, 12, 18 and 24 months.
16002619|NCT02869269|Device|Early stage|patients who classed as clinical stage 1 and 2
16002620|NCT02869269|Device|Late stage|patients who classed as clinical stage 3 and 4
16002621|NCT02869256|Other|Practices evaluation|Practices evaluation
16002622|NCT02869243|Drug|hrBMP4|"Patients will undergo a resection or biopsy of the tumour, confirmation of viable malignant glioma tumour cells and intratumour/interstitial placement under neuronavigational guidance of 2 or 3 catheters.
~Catheters will be placed during a second procedure a few days later based upon the patient's condition.
~Patients will receive intra-tumour and interstitial CED of increasing amounts of hrBMP4 solutions (starting dose of 0.5 mg) and 1:70 gadolinium-diethylenetriamine pentaacetic acid (Gd-DTPA) in a total of 44-66ml over up to 4-6 days. Gd-DTPA will be co-infused with BMP4 to determine the extent of intra-tumour and interstitial drug delivery. HrBMP4 will be delivered as a continuous infusion via the intracranial catheters."
16002623|NCT02869230|Procedure|ROLL|The ROLL technique (radioguided occult lesion localization) is characterized by the injection of a radiotracer in the center of the lesion
16002624|NCT02869230|Procedure|wire-guided lesion localization|wire-guided lesion localization, including better lesion centricity in relation to margins,decreased marking time, reduced surgery time, and better aesthetic outcomes
16002625|NCT02869217|Drug|Cyclophosphamide|
16002626|NCT02869217|Biological|TBI-1301|
16002627|NCT02869217|Drug|Fludarabine|
16002628|NCT02869204|Other|Leucocyte - Platelet rich Plasma|Autologous L-PRP are studied regarding it's accelerating effect on tissue repair.
16002629|NCT02869204|Dietary Supplement|Vitamin C|A daily dietary supplement of 500 mg Vitamin C. Provided from POD2-3 until POD30
16002630|NCT02869204|Dietary Supplement|Zinc|A daily dietary supplement of 44 mg Zinc. Provided from POD2-3 until POD30
16002631|NCT02869204|Dietary Supplement|L-Arginine|A daily dietary supplement of 5 g L-Arginine. Provided from POD2-3 until POD30
16002632|NCT02869165|Drug|Conjugated equine estrogen topical cream|Comparison of the bacterial communities in the vagina and urine of postmenopausal women who use Premarin vaginal cream versus apricot kernel oil and to themselves before and after use.
16002633|NCT02869165|Drug|Apricot kernel oil|Comparison of the bacterial communities in the vagina and urine of postmenopausal women who use Premarin vaginal cream versus apricot kernel oil and to themselves before and after use.
16002634|NCT02869152|Other|Endoscopic injection of 99mTc-sulfur colloid|Radiotracer injection around the rectal tumor for SLN mapping with gamma probe
16002635|NCT02869152|Other|Endoscopic injection of ICG|Dye injection around the rectal tumor for SLN mapping with NIR imaging.
16002636|NCT02869152|Other|Endoscopic injection of Spot|Dye injection for tattooing rectal tumor prior to surgical resection.
16002637|NCT02869152|Procedure|Flexible sigmoidoscopy|Flexible sigmoidoscopy prior to surgery to facilitate endoscopic injections of radiotracer and dyes.
16002638|NCT02869152|Procedure|Endoscopic NIR imaging and gamma probe|Endoscopic near infrared (NIR) imaging of ICG and detection of radiotracer with gamma probe after standard removal of rectal neoplasm.
16002639|NCT02869152|Procedure|Dissection of sentinel lymph node(s)|Surgical removal of identified lymph nodes in the rectum.
16002640|NCT02869139|Other|Mentholated lip moisturizer and ice popsicle|Mentholated package of measures
16002641|NCT02869139|Other|Non-mentholated lip moisturizer and ice popsicle|Non-mentholated package of measures
16002642|NCT02869126|Procedure|Tomoscintigraphy with D.SPECT camera (SPECTRUM Dynamics®, Israel)|"During stress test, intravenous injection of 99mTc-Sestamibi (between 80 and 150 MBq according to weight) in patient
~Stress conventional acquisition with D.SPECT camera 20 min after injection
~60 min after 99mTc-Sestamibi injection, rest injection of thallium-201 (50% activity of stress 99mTc-Sestamibi)
~double isotope acquisition 5 min after thallium-201 injection
~injection of 99mTc-Sestamibi at rest (activity 3 times higher), after 2 hours from first 99mTc-Sestamibi injection
~rest conventional acquisition 20 min later"
16002643|NCT02869126|Drug|99mTc-Sestamibi|"First intravenous injection between 80 and 150 MBq according to patient weight and second injection with 3-time-higher activity, 2 hours after the first
~For tomoscintigraphy"
16002644|NCT02869126|Drug|Thallium-201|"Injection of thallium-201 (50% activity of first 99mTc-Sestamibi injection)
~For tomoscintigraphy"
16002645|NCT02869113|Drug|BAY98751 (Y65-110)|10 µL in one eye
16002646|NCT02869113|Drug|BAY 98751 (Y65-102)|10 µL in one eye
16002647|NCT02869113|Drug|BAY 98751 (Y65-106)|10 µL in one eye
16002648|NCT02869113|Drug|Standard shampoo mixture (Control)|10 µL in other eye
16002649|NCT02869100|Other|Blood sample|
16002650|NCT02869100|Procedure|Sodium fluoride Positron Emission Tomography|
16002651|NCT02869100|Other|Magnetic Resonance Imaging|
16002652|NCT02869100|Other|Radiography|
16002653|NCT02869087|Device|Akesys Prava Scaffold|Implantation of the Akesys Prava Sirolimus Eluting Bioresorbable Peripheral Scaffold System
16002654|NCT02869074|Genetic|VWF gene analysis|52 exons adjacent intronic regions and promotor of VWF will be analyzed
16002655|NCT02869061|Procedure|Liposuction|
16002656|NCT02869061|Procedure|Transurethral bladder neck resection.|
16002657|NCT02869061|Biological|ADRC|Injection of ADRC suspension will be performed endoscopically into the bladder neck close to the site of resection.
16002658|NCT02869061|Other|ADRC isolation|ADRC will be isolated according to patent pending technology based on enzymatic digestion, washing and concentration of cell pellet in up to 9.5 ml of normal saline.
16002659|NCT02869035|Drug|Escitalopram|Patients will be treated with an antidepressant drug (escitalopram) at flexible standard doses for 12 weeks. If no response after 4 weeks; shift to duloxetine arm.
16002660|NCT02869035|Drug|Duloxetine|Patients who at 4 weeks of escitalopram have not responded will be shifted to duloxetine at flexible standard dosages.
16002661|NCT02869022|Drug|Custodiol-N|comparison of two Solutions, Custodiol-N versus Custodiol, for organ Perfusion in heart transplantation
16002701|NCT02868788|Dietary Supplement|dietary fiber|
16002662|NCT02869022|Drug|Custodiol|comparison of two Solutions, Custodiol-N versus Custodiol, for organ Perfusion in heart transplantation
16002663|NCT02869022|Procedure|organ perfusion for heart transplantation|
16002664|NCT02869009|Drug|clopidogrel|
16002665|NCT02869009|Drug|Aspirin|
16002666|NCT02868996|Drug|Recombinant human tissue kallikrein|Intravenous DM199
16002667|NCT02868983|Other|Integration|"The intervention consists of training for practice leaders, BHCs, PCPs, and office staff, a Protocolized Redesign Process support for practice redesign, and a toolkit of suggested tactics for implementing Tasks A through D:
~A. Identification B. Assessment C. Treatment D. Surveillance"
16002668|NCT02868970|Biological|Meningococcal B|Bexsero is indicated for active immunisation of individuals from 2 months of age and older against invasive meningococcal disease caused by Neisseria meningitidis group B.
16002669|NCT02868970|Biological|High-Dose TIV|Fluzone High-Dose is an injectable influenza vaccine made to protect against the flu strains most likely to cause illness for that particular flu season.
16002670|NCT02868970|Biological|Tdap (tetanus-diphtheria-acellular pertussis)|Tdap is a combination vaccine that protects against three potentially life-threatening bacterial diseases: tetanus, diphtheria, and pertussis (whooping cough).
16002671|NCT02868970|Biological|Meningococcal ACWY|Meningococcal ACWY vaccine is indicated for active immunization of individuals up to 55 years of age against invasive meningococcal diseases caused by Neisseria meningitides serogroups A, C, W-135 and Y.
16002672|NCT02868970|Biological|Herpes Zoster|Herpes zoster vaccine is indicated for the immunization of individuals 50 years of age or older for the prevention of herpes zoster (shingles).
16002673|NCT02868970|Biological|Travel Health (Hepatitis A, Hepatitis B, Typhoid Fever)|Hepatitis A vaccine is indicated for immunization against infections caused by hepatitis A virus; Hepatitis B vaccine is indicated for immunization against infection caused by hepatitis B virus; and typhoid fever vaccine is indicated for active immunization against Salmonella typhi, the organism which causes typhoid fever.
16002674|NCT02868957|Other|impression data from reference scanner|To create a reference images for the assessment of the trueness, the impressions of the upper and lower arch of the oral cavities of four patients were taken using a polyether impression material (3M ESPE Soft Monophase; Minnesota Mining and Manufacturing Co.), and the intaglio scanning was performed on the impression body using a desktop scanner. Scanned images were transformed to the Standard Tessellation Language (STL) file format, and used as reference images.
16002675|NCT02868957|Device|iTero|The participants visited the dental clinic and performed scanning for 4 days. In order to investigate the difference in the precision and trueness of iTero intraoral scanners, the participants scanned the dental arch of a single patient 10 times using an assigned digital intraoral scanner.
16002676|NCT02868957|Device|Trios|The participants visited the dental clinic and performed scanning for 4 days. In order to investigate the difference in the precision and trueness of Trios intraoral scanners, the participants scanned the dental arch of a single patient 10 times using an assigned digital intraoral scanner. .
16002677|NCT02868944|Drug|experimental group : sequential combined spinal epidural with local anesthetic injection (chirocaine) associated with morphine (sufentanil).|
16002678|NCT02868944|Drug|control group : sequential combined spinal epidural with local anesthetic injection (chirocaine) alone.|
16002679|NCT02868931|Behavioral|INPUT|"Treatment and education program based on the self-management theory of behavioral medicine.
~The program is delivered by certified and specially trained diabetes educators."
16002680|NCT02868918|Drug|biodentine|tricalcium silicate cement used to replace the carious dentin
16002681|NCT02868918|Drug|glass ionomer cement|high viscosity glass ionomer used as a base material
16002682|NCT02868918|Device|DigoraH optium|digital Xray for follow up
16002683|NCT02868905|Procedure|Blood sample|
16002684|NCT02868892|Drug|Pemetrexed|Pemetrexed 500 mg/m2
16002685|NCT02868879|Other|Quantitative multiparametric and functional MRI|"Structural connectivity assessed in the cortex and the white matter using multimodal quantitative parametric imaging (R1, R2, R2*, DTI, susceptibility, macromolecular proton fraction, cortical thickness, VBM).
~Functional connectivity assessed using simple BOLD and combined ASL-BOLD sequences during multiple tasks including motor, language and working memory tasks."
16002686|NCT02868866|Behavioral|Immediate Intervention|Committees from 40 churches will be trained in the Faith, Activity, and Nutrition program by Community Health Advisors. The training focuses on helping churches create healthier church environments for physical activity and healthy eating using Cohen's structural model of health behavior as a guide. Each church committee participates in a full-day training and submits a program plan and budget. Churches receive materials to support implementation of the program. After the full-day training, trained churches receive 12 monthly technical assistance calls to help them implement their program plan. The church coordinator receives 8 calls and the pastor receives 4 calls over the 12 months. In Phase 2, the intervention is open to any church in the SC Conference of the United Methodist Church.
16002687|NCT02868853|Behavioral|Photo App|Use of a mobile photo app that takes pictures of foods consumed and allows users to share these pictures with other members of the study in order to receive feedback.
16002688|NCT02868853|Behavioral|Diet App|Use of a mobile diet app that allows users to track all foods and beverages consumed in order to calculate the calories consumed each day.
16002689|NCT02868853|Behavioral|Podcasts|Listen to 2 podcasts per week about healthy eating and exercise.
16002690|NCT02868840|Behavioral|Tai Chi exercise|exercise twice a week each for one hour
16002691|NCT02868840|Behavioral|symptom management|sending text message weekly to manage symptoms related to stroke
16002692|NCT02868827|Drug|Cholecalciferol|400000 international Units of cholecalciferol will be dissolved in 45 ml of fresh milk (Nestle) and it will be given to interventional group patients through enteral route within 24 hours of ICU admission as a single dose.
16002693|NCT02868827|Other|Milk (Nestle)|45 ml of Nestle milk will given to patients assigned as placebo
16002694|NCT02868814|Drug|Pregabalin Release Tablets|
16002695|NCT02868814|Drug|Pregabalin Release Tablets|
16002696|NCT02868814|Drug|Placebo|
16002697|NCT02868801|Drug|Placebo|same intervention as the experimental group
16002698|NCT02868801|Drug|Pregabalin SR tablet 165mg/day|According to the efficacy and safety in titration
16002699|NCT02868801|Drug|Pregabalin SR tablet 330mg/day|According to the efficacy and safety in titration
16002703|NCT02868749|Device|Hyaluronic Acid filler|Linear retrograde, subcutaneous injection of 0,5 ml of hyaluronic acid gel in one side of the abdomen or one breast, 3 weeks to 4 months before the surgery.
16002704|NCT02868749|Device|Hyaluronic Acid filler|Linear retrograde, subcutaneous injection of 0,5 ml of hyaluronic acid gel in other side of the abdomen or other breast, 5 to 9 days before the surgery.
16002705|NCT02868736|Device|Synovasure PJI Lateral Flow test and Synovasure PJI ELISA Test|
16002706|NCT02868723|Other|Aggressive Management|With the aid of the nurse and pharmacist, the individuals in the interventional group will receive additional management of stroke by change is diet plan, increased exercise
16002707|NCT02868710|Other|Exercise|Continuous aerobic exercise prescribed according to two exercise intensity methods: individualized (i.e. ventilatory threshold) and standardized (i.e. heart rate reserve)
16002708|NCT02868697|Drug|TauroLock U 25000|taurolidine citrate, 4% citrate /25000 IU unit urokinase (TauroLock U25000
16002709|NCT02868697|Drug|(TauroLock Hep500)|1.35% taurolidine citrate (2H-1,2,4-thiadiazine-4,4'-methylenebis[tetrahydro-1,1,1',1'-tetraoxide], 4% citrate and 500 IU/ml heparin (TauroLock Hep500) (TauroPharmGmbH
16002710|NCT02868671|Other|acupuncture|
16002711|NCT02868671|Other|sham acupuncture|
16002712|NCT02868658|Biological|Blood sampling|
16002713|NCT02868658|Other|Nasal swab|
16002714|NCT02868645|Biological|Blood sampling|Patients with bone fibrous dysplasia will have blood sampling to assess periostin rate in serum
16002715|NCT02868632|Drug|MEDI4736|anti-PD-L1 human monoclonal antibody
16002716|NCT02868632|Drug|Tremelimumab|anti-CTLA4 human monoclonal antibody
16002717|NCT02868632|Radiation|Stereotactic Body Radiation Therapy (SBRT)|Stereotactic body radiation therapy (SBRT) will be administered at the standard dose of 6 Gy daily for 5 days.
16002718|NCT02868619|Other|Functional MRI|functional MRI assessed on all the volunteers in condition of hunger and in Condition of satiety
16002719|NCT02868619|Other|ADO-BEDS scale|Evaluate the severity of BED according to Marcus and Kalarchian temporary diagnosis criteria
16002720|NCT02868619|Other|R-CMAS scale|Evaluate the anxiety
16002721|NCT02868606|Other|Physiologic Insulin Therapy|
16002722|NCT02868606|Other|Sliding-Scale Insulin Therapy|
16002723|NCT02868593|Other|Pharyngeal swab|
16002724|NCT02868580|Drug|Triumeq|Triumeq, a combination of dolutegravir, abacavir and lamivudine is an anti-retroviral therapy indicated for people with HIV-1 infection.
16002725|NCT02868567|Drug|dalfampridine|Pill open label
16002726|NCT02868554|Device|AcceleDent Aura|Patients receiving vibration therapy will be instructed to bite down on the AcceleDent mouthpiece, which vibrates at a .25 Newtons (25 grams) force level with a 30 Hertz frequency for 20 minutes per day.
16002727|NCT02868554|Device|Accelerated Invisalign therapy|Patients receiving accelerated Invisalign therapy will be instructed to wear each aligner 24 hours day. Patients will be permitted to progress to the subsequent aligner after 4 days of compliant aligner wear.
16002728|NCT02868541|Other|Naso pharyngeal swab|
16002729|NCT02868528|Genetic|chromosome screening with NGS technology|
16002730|NCT02868515|Other|Hot cereal contain 3 g dietary fiber|Intervention involves consumption of a hot cereal over 14 day period
16002731|NCT02868502|Device|Goldmann tonometer|IOP measurement in the sitting position and lateral decubitus
16002732|NCT02868502|Device|Pneumatonometer|IOP measurement in the sitting position and lateral decubitus
16002733|NCT02868502|Device|Tonopen XL|IOP measurement in the sitting position and lateral decubitus
16002734|NCT02868502|Device|ICare rebound tonometer|IOP measurement in the sitting position and lateral decubitus
16002735|NCT02868489|Dietary Supplement|LactoWise®|blend of bacillus coagulans and galactomannans
16002736|NCT02868489|Other|Placebo|Placebo to be selected is calcium carbonate (since participant routine standard of care already includes intake of calcium citrate)
16002737|NCT02868450|Biological|Blood Sample|
16002738|NCT02868437|Device|intrauterine self-cross-linked hyaluronic acid gel|intrauterine self-cross-linked hyaluronic acid gel will apply after curettage for retained product after second trimester abortion
16002739|NCT02868424|Drug|fRPE cells|fRPE cells transplantation directly into the subretinal space of one eye (experimental eye) in a single transplant procedure
16002740|NCT02868411|Other|Rectal Swab|
16002741|NCT02868385|Drug|4x Praziquantel|Four consecutive praziquantel treatments (40 mg/kg): at baseline (week 0) and at week 2, 4, and 6.
16002742|NCT02868385|Drug|1x Praziquantel|One praziquantel treatment (40 mg/kg) at baseline
16002743|NCT02868372|Drug|Povidone iodine|After closure of the anterior wall of the rectus sheath, the subcutaneous tissues of the cesarean section wound will be swabbed with 10% undiluted Povidone iodine without mobbing.
16002744|NCT02868359|Other|No Intervention|The study is observational.
16002745|NCT02868346|Other|Anal swab|
16002746|NCT02868320|Other|SMS messages|"Daily educational messages addressing the following categories: diet, exercise, complications, medications, foot care, blood sugar testing, and hypo- and hyperglycemia.
~Weekly reminder messages of blood glucose testing."
16002747|NCT02868320|Other|Instruction booklet|General detailed instructions addressing the same SMS categories.
16002748|NCT02868307|Behavioral|Answering questionnaire|
16002749|NCT02868294|Device|Fassier-Duval Nail|Implementation of a telescopic system intramedullary
16002750|NCT02868281|Drug|ACT guided Routine Treatment|The ACT is a validated, short, easy to use, and self-administered instrument used to assess asthma control. Subjects in this group received routine treatment as per ACT score.
16002751|NCT02868281|Drug|Routine Treatment|Subjects in the controlled treatment group will receive usual care of asthma. This treatment was monitored and adjusted as usual by the patient's general practitioner.
16002752|NCT02868268|Other|Gene panel sequencing of tumor specimens|Archival or biopsied tumor specimens will undergo gene panel sequencing to identify subgroups with targetable genetic (ALK, MAPK pathway, Metabolic-related genes) and/or immunologic (tumor associated macrophage infiltration, PD-L1 expression) biomarkers in neuroblastoma. A clinical report will be provided to subjects/subject physician detailing observed mutations and identified NBL subgroups and information on clinical trials that best match them. Subjects will be followed and data collected on treatments administered for one year after receipt of clinical report.
16071132|NCT02374567|Drug|Zopiclone|
16002753|NCT02868255|Procedure|Collection of human samples|Several types of samples will be used to test the effect of the drug candidate
16002754|NCT02868242|Drug|LDV/SOF|Tablet(s) administered orally once daily
16002755|NCT02868229|Drug|COR-001|
16002756|NCT02868229|Other|Placebo|
16002757|NCT02868216|Behavioral|anger management training|
16002758|NCT02868203|Device|OCT|OCT after stent implantation
16002759|NCT02868203|Device|eLuting stent|
16002760|NCT02868190|Device|Two trabecular micro-bypass stents (iStent inject)|Standalone implantation of two trabecular micro-bypass stents (iStent inject)
16002761|NCT02868177|Dietary Supplement|Totum-63|Each randomized subject will consume 8 capsules daily of either active (5200 mg of Totum-63) during 24 weeks (from visit V1 to visit V3). They will consume 3 capsules at the beginning of their breakfast, 2 capsules at the beginning of their lunch and 3 capsules at the beginning of their dinner.
16002762|NCT02868177|Dietary Supplement|Placebo|Each randomized subject will consume 8 capsules daily of placebo (5064 mg of maltodextrine) during 24 weeks (from visit V1 to visit V3). They will consume 3 capsules at the beginning of their breakfast, 2 capsules at the beginning of their lunch and 3 capsules at the beginning of their dinner.
16002763|NCT02868164|Drug|Fecal Microbiota Transplantation|The recipient will receive healthy donor, prepared fecal installations through a Naso-gastric tube, 100 ml once a month for 6 month.
16002764|NCT02868164|Drug|Standard Treatment|Standard Treatment
16002765|NCT02868164|Other|Weight Reduction|routine exercise for weight reduction
16002766|NCT02868151|Drug|Ascorbic Acid|Ascorbic acid oral supplementation 1g four times daily for the entire treatment period and 30 days after treatment by tapering the dose of the drug to half. The drug has to be started 2 days prior to initiation of treatment of cancer.
16002767|NCT02868151|Drug|Zinc acetate|Zinc acetate 50mg tablets orally twice daily for entire period of cancer treatment
16002768|NCT02868125|Radiation|X ray radiography|All studied patients will undergo an x-ray radiography of the operated hip. This protocol is a part of the investigators' common practice policy regardless of the study.
16002769|NCT02868112|Other|Usual Oncology Care|Participants receiving usual oncology care will not meet routinely with geriatric clinicians, though they may receive a geriatrics consult at their request or at the discretion of their treating team.
16002770|NCT02868112|Other|Transdisciplinary Intervention|Patients randomized to the transdisciplinary intervention will undergo evaluation with a board-certified geriatric clinician, who will tailor their care based on the results of a brief geriatric screening tool, completed prior to their visit. We will test a two-visit transdisciplinary intervention with the first visit occurring within four weeks of enrollment and the second visit four weeks after the initial visit.
16002771|NCT02868099|Drug|Romiplostim|
16002772|NCT02868099|Drug|Placebo|
16002773|NCT02868086|Device|OCT B-scans|
16002774|NCT02868086|Device|OCT angiography|
16002775|NCT02868073|Biological|VXA-G1.1-NN (high dose) Oral Vaccine Tablet|The drug product will be provided as small white enteric-coated tablets. Multiple tablets will be administered to deliver the high dose.
16002776|NCT02868073|Other|VXA Placebo Tablets|The placebo will be provided as small white enteric-coated tablets that are similar in size and number to the active drug product tablets.
16002777|NCT02868073|Biological|VXA-G1.1-NN (low dose) Oral Vaccine Tablet|The drug product will be provided as small white enteric-coated tablets. Multiple tablets will be administered to deliver the low dose.
16002778|NCT02868060|Drug|Romiplostim|
16002779|NCT02868047|Procedure|Endoscopic Ultrasound|Patients will undergo elective upper endoscopic ultrasound to evaluate the pancreas in patients both with and without chronic pancreatitis
16002780|NCT02868034|Behavioral|SMT|"All patients receive 2 SMT sessions in the first week. The subject is supine. The clinician stands opposite the side to be manipulated and side-bends the subject away from the side to manipulate. The side to be manipulated is the more painful. If the subject cannot identify a more painful side the clinician selects a side. The clinician rotates the subject, and delivers a high-velocity, low-amplitude (HVLA) thrust to the pelvis in a posterior/inferior direction. The clinician notes if a cavitation (ie, a pop) occurred. If it does, SMT treatment is complete. If no cavitation occurs, the subject is repositioned and SMT is performed again. If no cavitation occurs on the second attempt, the clinician manipulates the opposite side. A maximum of 2 attempts per side is permitted. If no cavitation is noted by that time, SMT treatment is complete. Substitution with a side-posture HVLA technique is allowed if the preferred technique is not possible due to subject preference or comfort."
16002781|NCT02868034|Behavioral|Mobilizing Exercises|Mobilizing exercises will include a program of repeated movements progressing into end-ranges of spinal flexion and/or extension shown in past studies to improve ROM and reduce spinal stiffness. Patients will be instructed in mid-range exercises and will be further assessed for a directional preference. A directional preference is present if movement in a particular direction decreases LBP intensity or causes symptoms to centralize towards the midline. If a subject has a directional preference he or she will be prescribed exercises specifically in that direction along with mid-range exercise. Otherwise the subject will be assigned exercises moving into either flexion or extension based on the clinician's discretion. Subjects will perform their prescribed exercises at treatment sessions and will be instructed to perform the exercises daily on other days.
16002782|NCT02868034|Behavioral|Activation Exercises|Activation exercises are designed to facilitate use of the lumbar multifidus muscle. Exercises will begin with isometric multifidus contractions in different positions with clinician feedback and exercises to isometrically co-contract the multifidus and deep abdominal muscles. Subjects will also perform lumbar extensor strengthening exercises shown to produce 20%-50% of multifidus maximum voluntary contraction. Subjects will continue to perform isometric exercises throughout treatment. Subjects will perform their prescribed exercises at treatment sessions and will be instructed to perform the exercises daily on other days.
16002783|NCT02868034|Behavioral|SMT extended|This treatment involves 6 additional SMT sessions. Each SMT session is conducted as described previously.
16002784|NCT02868021|Device|Strength testing|Test the strength of subject's lower extremity muscles on the dynamometer system
16002785|NCT02868021|Behavioral|Short Physical Performance Battery (SPPB)|The SPPB is a timed short distance walk, repeated chair stands, and balance test that measures lower extremity function.
16002944|NCT02866942|Drug|Administration of Live attenuated influenza vaccine (LAIV)|
16002786|NCT02868021|Behavioral|Six-minute walk (SMW)|Subjects walk back and forth along a 100-ft hallway for six minutes after instructions to complete as many laps as possible.
16002787|NCT02868021|Behavioral|Numerical pain scale|Measure pain using an 11-point numerical pain scale.
16002788|NCT02868021|Behavioral|Self-assessed function|Using the Late Life Function and Disability Instrument.
16002789|NCT02868021|Procedure|Muscle biopsies|During the course of the surgery two small muscle biopsies from the quadriceps muscle of the operative leg will be collected.
16002790|NCT02868021|Device|Determination of 1 Repetition Maximum (1-RM)|Following the warm-up, subjects will attempt to complete one repetition of the leg press exercise at progressively greater resistance until a full repetition can no longer be performed. The weight of the last complete unassisted repetition will be recorded as the 1-RM.
16002791|NCT02868021|Device|Blood flow restriction exercise|Perform lower-extremity exercises (leg press, leg extension, leg curl, and calf extension) at an intensity of 30% of 1-RM with external compression applied to the proximal thigh of each leg.
16002792|NCT02868021|Behavioral|Borg CR10 scale|Following each exercise session, participants will provide a rating of perceived exertion (RPE) for the session according to the Borg CR10 scale.
16002793|NCT02868008|Procedure|Microsurgical resection of brain AVMs|fMRI guided microsurgical resection of brain AVMs
16002794|NCT02867995|Device|Eye Drop Aid|Fabrication Autodrop Eye Drop Guide,Owen Mumford OP 6100 Autosqueeze, and the Simply Touch Eye Drop Applicator
16002795|NCT02867982|Procedure|Subcrestal implant placement|Dental implants placed 2 mm below the alveolar ridge
16002796|NCT02867982|Procedure|Paracrestal implant placement|Dental implants placed flush to the alveolar ridge
16002797|NCT02867982|Drug|prophylactic antibiotics|amoxicillin was used before and after implant surgery for prophylactic reasons
16002798|NCT02867982|Device|dental implant|dental implants (Ankylos® system,Dentsply Implants Manufacturing GmbH, Mannheim, Germany) were surgically placed into the edentulous alveolar ridge
16002799|NCT02867982|Radiation|x-ray examination|radiographies were taken before treatment and at different time point during the follow-up period
16002800|NCT02867969|Other|Motor training|The motor training will comprise of demanding coordinative exercises based on commercially available developed by Microsoft Game Console (XBOX Kinect™) exergames that specifically target ataxia dysfunctions.
16002801|NCT02867956|Drug|Apatinib|Apatinib 500mg daily, po, and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent.
16002802|NCT02867956|Drug|Etoposide|Etoposide 50mg daily, po, day 1 to day 14, repeat every 21 days for 6 cycles
16002803|NCT02867943|Other|Effects of respiratory rate on gapCO2|respiratory rate was started at 10 breaths/min and added by 2 breaths/min every 60 min up to 16 breaths/min
16002804|NCT02867930|Drug|Dexmedetomidine|drug for moderate sedation in trans-esophageal echocardiography
16002805|NCT02867930|Drug|Ketofol(ketamine+propofol)|drug for moderate sedation in trans-esophageal echocardiography
16002806|NCT02867917|Drug|Volcolon sugar free|1 sachet contains 4 g powder 980mg/g psyllium fibers x 4 g per sachet = 3.92 g psyllium fibers/sachet
16002807|NCT02867917|Drug|Metamucil Orange|1 sachet contains 3.4 g psyllium fibers So 25 ml contains 0.425 g psyllium fibers
16002808|NCT02867917|Drug|Psyllium Orange|1 sachet contains 3.25 g psyllium fibers So 25 ml contains 0.406 g psyllium fibers
16002809|NCT02867904|Drug|Methylprednisolone (40 mg depomedrol, 1ml, injection)|Experimental Drug
16002810|NCT02867904|Drug|Marcaine (4ml 0.5%, injection)|Control
16002811|NCT02867878|Drug|Adenosine|
16002812|NCT02867878|Drug|Saline solution|
16002813|NCT02867865|Drug|Gemcitabine|Those randomized to systemic chemotherapy alone will proceed to receive Chemotherapy Gemcitabine gemcitabine 1000 mg/m2delivered day 1 and 8 every 3 weeks for 4 cycles
16002814|NCT02867865|Drug|Cisplatin|Inj. cisplatin 25 mg/m2 delivered. day 1 and 8 every 3 weeks for 4 cycles
16002815|NCT02867865|Radiation|Chemoradiation|Radiotherapy will be for 5 weeks and will be given only in the study arm. The radiation dose will be 50-55 Gy/ 25 fractions to the gross disease and 45 Gy/ 25 fractions to suspected microscopic disease along with weekly gemcitabine (300 mg/ m2).
16002816|NCT02867865|Procedure|PETCECT|All the patients will undergo PETCECT to rule out metastatic disease
16002817|NCT02867865|Procedure|Laparoscopy|Patients will be subjected to staging laparoscopy with 16b1 lymph node biopsy to rule out metastatic disease.
16002818|NCT02867852|Drug|Abiraterone acetate|Abiraterone acetate is a prodrug of abiraterone, an irreversible inhibitor of 17α hydroxylase/C17, 20-lyase (cytochrome P450c17 [CYP17]), a key enzyme required for testosterone synthesis. This enzyme is found in the testes, adrenals, prostate tumors
16002819|NCT02867839|Drug|Oxaliplatin plus S-1|8 cycles of adjuvant chemotherapy with Oxaliplatin plus S-1
16002820|NCT02867839|Drug|S-1 only|16 cycles of adjuvant chemotherapy with S-1 only
16002821|NCT02867826|Device|Cap|Cap-assisted endoscopy
16002822|NCT02867813|Biological|Evolocumab|subjects will receive evolocumab 140 mg every 2 weeks (Q2W) or 420 mg monthly (QM), according to the subject's preference.
16002823|NCT02867800|Drug|Diphenhydramine|"(Standard of Care) Premedication
~Diphenhydramine: 1 mg/kg IV or PO q 8 hours (maximum=50 mg)"
16002824|NCT02867800|Drug|Acetaminophen|"(Standard of Care) Premedication
~Acetaminophen: 10-15 mg/kg PO q 6 hours (maximum=1000 mg)"
16002825|NCT02867800|Drug|Methylprednisolone|"(Standard of Care) Premedication
~Methylprednisolone: 0.25-0.5 mg/kg IV q 6 hours"
16002826|NCT02867800|Drug|Meperidine|"(Standard of Care) Premedication
~Use as needed (PRN) Meperidine: 0.5 mg/kg IV q 4-6 hours (for rigors)"
16002827|NCT02867800|Drug|Alemtuzumab|"(Standard of Care) Immunosuppression
~Alemtuzumab:
~A test dose of alemtuzumab, 3 mg, should be administered IV over 2 hours the first day. If the test dose is tolerated, administration of three treatment doses should begin within 24 hours. The three treatment doses should be administered on consecutive days. 10 mg/m2 should be given the first day, 15 mg/m2 the second and 20 mg/m2 the third."
16002828|NCT02867800|Drug|Thymoglobulin|"(Standard of Care) Immunosuppression
~Thymoglobulin: A 4 mg/kg dose of anti-thymocyte globulin should be administered in place of each alemtuzumab dose not completed."
16002829|NCT02867800|Drug|Fludarabine|"(Standard Conditioning Regimen)
~Fludarabine should be administered 30 mg/m2 IV daily for five days. It should be infused over 30 to 60 minutes."
16003058|NCT02866175|Drug|Prasugrel|prasugrel 5mg or 10 mg once-daily
16002830|NCT02867800|Drug|Melphalan|"(Standard Conditioning Regimen)
~Melphalan should be administered 140 mg/m2 IV 3 days before marrow infusion. It should be infused within 60 minutes of preparation and over a maximum of 30 minutes. It should be infused immediately after the fludarabine infusion is complete."
16002831|NCT02867800|Drug|Thiotepa|"(Standard Conditioning Regimen)
~Thiotepa should be administered 8 mg/kg IV 3 days before marrow infusion. It should be infused immediately after the fludarabine infusion is complete. The thiotepa should be infused over one hour."
16002832|NCT02867800|Drug|Cyclosporine|"(Standard GVHD Prophylaxis) Calcineurin inhibitor
~Cyclosporine: Administration will commence no later than at least 36 hours before marrow infusion; Cyclosporine doses will be adjusted to maintain a level of 150-300 ng/ml."
16002833|NCT02867800|Drug|Tacrolimus|"(Standard GVHD Prophylaxis) Calcineurin inhibitor
~Tacrolimus: Administration will commence no later than at least 36 hours before marrow infusion; Tacrolimus doses will be adjusted to maintain a level of 8-15 ng/ml."
16002834|NCT02867800|Drug|Methotrexate|"(Standard GVHD Prophylaxis)
~Methotrexate will be given at a dose of 15 mg/m2 IV on day 1 and a dose of 10 mg/m2 IV on days 3, 6 and 11. Dosing shall be based on actual weight."
16002835|NCT02867800|Drug|Abatacept|"(Investigational)
~Abatacept will be administered intravenously at a dose of 10 mg/kg based on actual weight with a maximum of 750 mg. In cases where the calculated dose is less than or equal to 110% of a simple multiple of a 250 mg vial: 250 mg (275mg), 500 mg (550 mg) or 750 mg (825 mg), the dose may be rounded down to the nearest multiple. No rounding up of the abatacept dose is permitted."
16002836|NCT02867800|Procedure|Marrow infusion|"(Standard)
~A procedure that infuses healthy cells, called stem cells, into your body to replace damaged or diseased bone marrow. A bone marrow transplant may also be used to treat certain types of cancer"
16002837|NCT02867800|Drug|Sirolimus|"(Standard GVHD Prophylaxis)
~Calcineurin inhibitor (cyclosporine or tacrolimus or with permission of the sponsor: sirolimus or mycophenolate mofetil (MMF)) administration will commence no later than day -2 (at least 36 hours before the stem cell infusion); cyclosporine doses will be adjusted to maintain a level of 150-300 ng/ml. This range assumes monitoring by mass spectrometry. If an immunoassay is used instead, the equivalent range for that immunoassay should be used."
16002838|NCT02867800|Drug|Mycophenolate Mofetil|"(Standard GVHD Prophylaxis)
~Calcineurin inhibitor (cyclosporine or tacrolimus or with permission of the sponsor: sirolimus or mycophenolate mofetil (MMF)) administration will commence no later than day -2 (at least 36 hours before the stem cell infusion); cyclosporine doses will be adjusted to maintain a level of 150-300 ng/ml. This range assumes monitoring by mass spectrometry. If an immunoassay is used instead, the equivalent range for that immunoassay should be used."
16002839|NCT02867787|Drug|Botox arm|
16002840|NCT02867774|Behavioral|Physical Activity|"8 week exercise program specifically designed for patients with chronic pain at Transitions Training Studio, a rehab-focused, medically-based fitness center based at the University of Michigan.
~The program is designed to gradually increase intensity and duration. If causes pain exacerbation, patients will go back to earlier level of intensity. It favors short, frequent activity episodes as this is often better tolerated than longer, infrequent episodes. The program begins with 30 minutes sessions 3 times per week with goal of increasing duration over course of the program.
~The program incorporates elements of flexibility, strength and cardio. Program design includes common elements but allows for a personalized program based on a subject's baseline fitness, interest and tolerance to activity. The program design emphasizes activities that patients can incorporate into their daily routine."
16002841|NCT02867761|Drug|Indacaterol/Glycopyrrolate|27.5/15.6 mcg active indacaterol/glycopyrrolate
16002842|NCT02867761|Drug|Placebo|27.5/15.6 mcg placebo
16002843|NCT02867748|Procedure|TVT-Abbrevo|
16002844|NCT02867748|Procedure|Serasis|
16002845|NCT02867735|Drug|LKA651|Interventional
16002846|NCT02867735|Other|Sham Comparator|
16002847|NCT02867722|Drug|aminolevulinic acid HCl|Drug will be administered to consented patients
16002848|NCT02867709|Drug|Ubrogepant|Ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
16002849|NCT02867709|Drug|Placebo-matching Ubrogepant|Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
16002850|NCT02867696|Other|Standard Care|Subjects in this arm will receive the standard care that is provided by their bariatric surgical team following bariatric surgery.
16002851|NCT02867696|Behavioral|Technology-based Intervention (TECH)|"Dietary recommendations: based on the subjects' baseline body weight, with calorie goals ranging from 1200-2100 kcal/day.
~The physical activity component: unsupervised home-based exercise program. Intensity/Mode: aerobic physical activity recommended at a moderate intensity. Prescription: progress to 250 min/wk by 13th week of the intervention.
~Self-monitoring: Jawbone UP3 System includes a wearable device to monitor physical activity and energy expenditure that will transmit real-time feedback on calories expended and physical activity directly to a smart phone. An integrated digital smart scale will also be provided.
~Contact: scheduled intervention telephone call: Month 1: One call per week for the first 4 weeks of the study; Months 2-6: One call per month."
16002852|NCT02867683|Other|Vibrotactile Feedback|Balance training Vibrotactile feedback applied to the trunk
16002853|NCT02867670|Device|Transcranial Magnetic Stimulation|TMS is a form of non-invasive brain stimulation which uses magnetic pulses to stimulate regions of the brain from outside the head, on the scalp. Specifically, TMS is performed with a copper-and-plastic coil that emits a magnetic field, which can affect brain cells in specific locations. In this study, researchers will also use a form of TMS called theta-burst stimulation (TBS), where TMS pulses are delivered rapidly over time.
16002854|NCT02867657|Behavioral|Mindfulness|Five days MBSR curriculum with meditation and yoga
16002855|NCT02867644|Other|standard care|Patients coming for preoperative breast assessment will have standard care.
16002856|NCT02867644|Other|standard care + conversational hypnosis|Patients coming for preoperative breast assessment will have standard care with conversational hypnosis
16002857|NCT02867631|Behavioral|6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes|6 week challenge with 1 year of home visits: health texting, in home exercise supports, social support, healthy eating and feeding classes
16002858|NCT02867618|Drug|Carfilzomib|Carfilzomib given intravenously twice a week for 3 consecutive weeks, on days 1, 2, 8, 9, 15, and 16 on the 28-day cycle. This will be in combination with the oral TGR-1202
16003059|NCT02866175|Drug|Ticagrelor|ticagrelor 90 mg twice-daily
16002859|NCT02867618|Drug|TGR-1202|Oral TGR-1202 will be given PO once daily on Days 1-28 . This will be given in combination with the intravenous Carfilzomib
16002860|NCT02867605|Dietary Supplement|Hyaluronan|
16002861|NCT02867592|Drug|Cabozantinib|Given IV
16002862|NCT02867592|Drug|Cabozantinib S-malate|Given PO
16002863|NCT02867592|Other|Pharmacological Study|Correlative studies
16002864|NCT02867579|Behavioral|"evaluation of the child quality attachment (Strange situation)"|
16002865|NCT02867566|Drug|IBI301 plus CHOP|Six cycles. IBI301: 375 mg/m2, IV, day 1 of each cycle; Cyclophosphamide: 750 mg/m2, IV, day 2 of each cycle; Doxorubicin: 50 mg/m2, IV, day 2 of each cycle; Vindesine: 4 mg, IV, day 2 of each cycle; Prednisone: 100 mg, po, day 2 to day 6 of each cycle.
16002866|NCT02867566|Drug|Rituximab plus CHOP|Six cycles. Rituximab: 375 mg/m2, IV, day 1 of each cycle; Cyclophosphamide: 750 mg/m2, IV, day 2 of each cycle; Doxorubicin: 50 mg/m2, IV, day 2 of each cycle; Vindesine: 4 mg, IV, day 2 of each cycle; Prednisone: 100 mg, po, day 2 to day 6 of each cycle.
16002867|NCT02867553|Drug|rituximab|
16002868|NCT02867553|Radiation|Multi-fields radiotherapy|
16002869|NCT02867540|Other|MRI enterography|
16002870|NCT02867514|Device|transcranial Direct Current Stimulation (tDCS)|After locating the stimulation areas, treatment will be delivered during 30-minute session. Treatment will be occur 1 session per day during 10 days (5 days per week during 2 successive weeks). Subjects will be monitored during tDCS for any side effects or adverse events.
16002871|NCT02867488|Other|Soybean oil in salad dressing|
16002872|NCT02867475|Other|Physical activity motivation|Physical activity motivation
16002873|NCT02867462|Other|Standard care|standard care
16002874|NCT02867462|Other|manipulator consultation radiotherapy added to standard care|
16002875|NCT02867449|Behavioral|Metacognitive Therapy|Metacognitive Therapy for OCD according to Wells (1997)
16002876|NCT02867449|Behavioral|Exposure and Response Prevention|Exposure and Response Prevention for OCD according to Kozak & Foa (1997)
16002877|NCT02867436|Other|Gluten-free diet|
16002878|NCT02867423|Device|CK Boost radiation|single dose of 8 Grays is issued by the CK to the 6th week after conventional radiation
16002879|NCT02867410|Other|No intervention|
16002880|NCT02867397|Drug|Teysuno (S1) in combination with epirubicin and oxaliplatin|
16002881|NCT02867384|Drug|Obinutuzumab|B cell depletion
16002882|NCT02867384|Drug|Placebo|Placebo
16002883|NCT02867371|Device|Archimedes System|The Archimedes System is an image-guided navigation system used to access tissue samples in the lungs
16002884|NCT02867358|Drug|KT07 Capsule|
16002885|NCT02867358|Other|Placebo|
16002886|NCT02867345|Biological|PD-1 Knockout T Cells|PD-1 Knockout T Cells and PD-1 wild-type T Cells will be made by Cell Biotech Co., Ltd. 2x107/kg T cells will be used for test group and comparable group separately.
16002887|NCT02867345|Drug|Cyclophosphamide|"Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.
~Interleukin-2 (IL-2) will be given in the following 5 days, 720000 international unit（IU）/Kg/day (if tolerant)."
16002888|NCT02867345|Drug|IL-2|Interleukin-2 (IL-2) will be given in the following 5 days after cell infusion, 720000 international unit（IU）/Kg/ day (if tolerant).
16002889|NCT02867332|Biological|PD-1 Knockout T Cells|PD-1 Knockout T Cells and PD-1 wild-type T Cells will be made by Cell Biotech Co., Ltd. 2x107/kg T cells will be used for test group and comparable group separately.
16002890|NCT02867332|Drug|Cyclophosphamide|"Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.
~Interleukin-2 (IL-2) will be given in the following 5 days, 720000 international unit（IU）/Kg/day (if tolerant)."
16002891|NCT02867332|Drug|IL-2|Interleukin-2 (IL-2) will be given in the following 5 days after cell infusion, 720000 international unit（IU）/Kg/ day (if tolerant).
16002892|NCT02867319|Biological|A dose of ACYW135 meningococcal polysaccharide vaccine|A dose of ACYW135 meningococcal polysaccharide vaccine will be given in certain arm.
16002893|NCT02867306|Drug|ASP1707|Oral
16002894|NCT02867306|Drug|methotrexate (MTX)|Oral
16002895|NCT02867293|Procedure|ultrasound guided ascitic fluid drainage|
16002896|NCT02867293|Procedure|operative drainage of ascites through small skin incision after induction of anesthesia|
16002897|NCT02867293|Device|ultrasound|
16002898|NCT02867280|Drug|Sorafenib|red round tablet
16002899|NCT02867267|Drug|Thymosin alpha 1|Subcutaneous injections of 1.6 mg thymosin alpha 1 every 12±2 hours for not more than 7 days depending on the change of the subjects' condition, prior to administration, the lyophilized powder is to be reconstituted with 1 ml of the provided diluent.
16002900|NCT02867267|Other|Placebo|Subcutaneous injections of placebo every 12±2 hours for not more than 7 days depending on the change of the subjects' condition, prior to administration, the lyophilized powder is to be reconstituted with 1 ml of the provided diluent.
16002901|NCT02867241|Behavioral|Behavioral Early|Participants will receive an intervention which includes motivational interviewing, biochemical feedback, air quality feedback, phone calls, and social media
16002902|NCT02867241|Behavioral|Behavioral Late|After the close of the study, Participants will receive an intervention which includes motivational interviewing, biochemical feedback, air quality feedback, phone calls, and social media
16002903|NCT02867228|Other|changes in ventilator settings|Ventilator settings will be adjusted (vent mode, pressure support/control level, cycling, inspiratory time, mandatory rate).
16002904|NCT02867215|Other|Barley bread|120g barley bread per day for 3 weeks.
16002905|NCT02867215|Other|Wheat bread|120g wheat bread per day for 3 weeks.
16002906|NCT02867202|Device|Intrauterine balloon|After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week.
16002907|NCT02867202|Device|Intrauterine Contraceptive Device Plus Foley Catheter|After the completion of hysteroscopic adhesiolysis, Intrauterine Contraceptive Device Plus Foley Catheter were inserted into the uterine cavity. Foley Catheter was removed after three days and Intrauterine Device was removed at the second time of hysteroscopy.
16002908|NCT02867189|Other|atlas of micro-instrument|Nurses after training can improve the instrument cleaning quality, reduce the reaction after cataract surgery
16003063|NCT02866149|Procedure|Tumor sampling|One tumor sampling can be performed, if applicable
16002909|NCT02867176|Drug|Gabapentin|The gabapentin (Neurontin, Pfizer, Mexico) group was instructed to take one 300-mg capsule the night before surgery and 1 capsule every 8 hours on the day of surgery and for the first 3 postoperative days.
16002910|NCT02867176|Drug|Ketorolac|The ketorolac group (Dolac, Siegfried Rhein, Mexico) was instructed to take their 10-mg tablets every 8 hours on the day of surgery and for the first 3 postoperative days.
16002911|NCT02867163|Drug|Tranexamic Acid|Intravenous or local administration of TXA, in any dosage
16002912|NCT02867150|Device|Ward Photonics Photonica Professional|"Active Device: Ward Photonics, Photonica Professional Red light therapy system
~UltraSlim Cold Light® is the name of a patented treatment regimen using the Photonica Professional device for fat removal using LED red light therapy."
16002913|NCT02867137|Other|Blood sampling|Blood sampling from peripheral venous catheter routinely inserted in trauma patients during transportation
16002914|NCT02867124|Drug|XR-NTX|Vivitrol
16002915|NCT02867124|Other|place of residence|One injection of XR-NTX in prison, followed by 6 monthly injections post-release at place of residence
16002916|NCT02867124|Other|opioid treatment program|One injection of XR-NTX in prison, followed by 6 monthly injections post-release at a community opioid treatment program
16002917|NCT02867111|Device|Sperm Selection Assay|Sperm Selection Assay (SSA) that allow the investigators to select functional spermatozoa, which are capacitated, with intact DNA, reduced oxidative stress and with good viability and motility, on the basis of sperm chemotaxis towards a physiological attractant molecule.
16002918|NCT02867111|Other|Attractant Substance|Capacitated spermatozoa may be oriented by following an increasing concentration gradient of an attractant molecule, a phenomenon called sperm chemotaxis. This is a guidance mechanism observed in vitro, which may transport and retain spermatozoa at the fertilization site. Though several molecules have been suggested to attract human spermatozoa, in the context of gamete interaction prior to fertilization, progesterone has biological importance for several reasons. After ovulation, this hormone is secreted by the cumulus cells that surround the oocyte, diffusing to form a molecular gradient toward the periphery of the cumulus and beyond. Notably, a gradient of very low concentrations (picomolar) of progesterone is sufficient to chemically attract capacitated human spermatozoa
16002919|NCT02867111|Procedure|ICSI|An in vitro fertilization procedure in which a single sperm is injected directly into an egg
16002920|NCT02867098|Drug|XmAb5871|
16002921|NCT02867085|Other|Observational|The BoHemE study does not provide any recommendations for treatment. Guidelines for osteoporosis treatment and standardized instructions for MDS patients are available, however the choice of treatment is up to the treating physician and should be reported as such.
16002922|NCT02867072|Procedure|Open appendectomy|
16002923|NCT02867072|Procedure|Laparoscopic appendectomy|
16002924|NCT02867059|Drug|(+)-SJ000557733|(+)-SJ000557733 (SJ733), in short SJ733, will be the second PfATP4 inhibitor to enter clinical development after KAE609 (Novartis) which is currently in Phase 2 stage. KAE609 (cipargamin; previously known as NITD609) is a spirotetrahydro-β-carbolines (spiroindolone). KAE609 inhibits QP15C20_SJ733_Challenge Protocol_v2.0_26July2016 Page 28 of 110 PfATP4, which results in a disruption of parasite sodium homeostasis. Compared to KAE609, SJ733 has the potential to be a very fast acting, antimalarial drug for human therapeutic application and may have a different safety profile in human participants. Finally, SJ733 blocks parasite transmission in vivo at potencies close to those where it is efficacious in blood stages, indicating its potential for transmission blockade in humans.
16002925|NCT02867046|Drug|S1 transforaminal epidural steroid(dexamethasone) injection|"medial approach group (n=85): check intravascular injection while performing S1 transforaminal epidural steroid(dexamethasone) injection in medial side of S1 foramen under fluoroscopy
~lateral approach group (n=85): same as medial approach group except using lateral side of S1 foramen"
16002926|NCT02867033|Procedure|biopsy|pre-therapeutic or post-therapeutic biopsy or resected tissues
16002927|NCT02867033|Other|biobank constitution|Constitution of a biobank with pre-therapeutic or post-therapeutic biopsy or resected tissues
16002928|NCT02867033|Procedure|Coloscopy|For adult patients, a coloscopy with chromoscopy of ascending and sigmoid colon will be performed
16002929|NCT02867033|Procedure|Blood sampling (facultative)|Blood sample can be collected at diagnostic or after medically significant events (progressive disease, local or systemic treatment, pregnancy...)
16002930|NCT02867033|Other|Pain evaluation|Pain evaluation (EVA scale), anxiety (HADS questionnaire), quality of life questionnaire (EORTC-QLQ-C30)
16002931|NCT02867033|Procedure|Tumor biobank realization|Realization of a tumor biobank is part of classical procedure of participating centers
16002932|NCT02867020|Drug|Apalutamide|APALUTAMIDE 240-mg orally once daily (4 x 60-mg tablets) will be administered on a continual basis. For the purpose of scheduling the study assessments and treatment compliance a treatment cycle is defined as 28 days.
16002933|NCT02867020|Drug|Abiraterone|Abiraterone acetate 1,000 mg (four 250 mg tablets) should be taken orally once daily, in combination with oral dose prednisone 5mg twice daily continuously. For the purpose of scheduling the study assessments and treatment compliance a treatment cycle is defined as 28 days
16002934|NCT02867020|Drug|ADT|Dosing of goserelin (dose and frequency of administration) will be consistent with the prescribing information and should only be adjusted if clinically indicated to achieve and maintain subcastrate concentrations of testosterone (50 ng/dL or 1.7 nM).
16002935|NCT02867020|Drug|Prednisone|Subjects will receive prednisone 10mg/day.
16002936|NCT02867007|Drug|KHK2455|oral dosing
16002937|NCT02867007|Drug|Mogamulizumab|i.v. administration
16002938|NCT02866994|Behavioral|Project Connect Online|Three-hour workshop to complete personal website regarding breast cancer experience to share with friends and family
16002939|NCT02866994|Behavioral|PCO PLUS|Three-hour workshop to complete personal website regarding breast cancer experience to share with friends and family, as well as other women diagnosed with breast cancer
16002940|NCT02866981|Other|Observation|
16002941|NCT02866968|Procedure|FLAPS|Surgical procedures will involve 1) excision of pterygium tissue from cornea and conjunctiva, 2) resection of residual Tenon and coagulation to stop any bleeding 3) preparation of a 8x8 mm conjunctiva autograft in the superior bulbar conjunctiva with the femtosecond laser (12 o´clock position) and 4) fixation of the graft with fibrin glue to the resection site.
16002942|NCT02866955|Drug|Estramustine|140mg/4 caps/day
16002943|NCT02866955|Drug|Tamoxifen|20mg/day
16002945|NCT02866929|Procedure|Decortication|Under local anesthesia, vertical and inter-radicular gingival incisions will be performed on the vestibular of the maxillary and mandibular arch, starting 2-3 mm below the interdental papilla and with sufficient depth to the periosteum to allow the scalpel to reach the alveolar bone. These incisions will be kept as small as possible; then, through them, using a piezoelectric scalpel (piezotome), several bone cuts will be performed. These cuts will have sufficient depth for drilling the cortical alveoli.
16002946|NCT02866929|Device|Orthodontics|Self-ligation brackets in upper and lower teeth
16002947|NCT02866929|Drug|Mucograft|Porcine naturally cross-linked collagen matrix
16002948|NCT02866916|Drug|SXL01|Treatment will be administered continuously over 24h through the subcutaneous route.
16002949|NCT02866903|Drug|intraperitoneal (IP) OXAliplatin (OXA) + systemic FOLFIRI bevacizumab chemotherapy|Intraperitoneal (IP) OXAliplatin (OXA) in association with systemic FOLFIRI bevacizumab chemotherapy Intraperitoneal (IP) OXAliplatin (OXA) + systemic FOLFIRI (Irinotecan IV + 5-FU IV) bevacizumab chemotherapy in escalation dose (every 14 days) starting with the level 1
16002950|NCT02866903|Drug|intraperitoneal (IP) OXAliplatin (OXA) + systemic FOLFIRI bevacizumab chemotherapy|systemic FOLFIRI chemotherapy
16002951|NCT02866903|Drug|intraperitoneal (IP) OXAliplatin (OXA) + systemic FOLFIRI bevacizumab chemotherapy|bevacizumab
16002952|NCT02866890|Device|Laryngeal Tube Suction|Laryngeal Tube Suction Measurement of leak pressure
16002953|NCT02866877|Other|Pharmacokinetic modeling|Timed blood draws and urine collections to model drug clearance
16002954|NCT02866864|Other|Animal allergy +|Allergic symptom occurs when subject contact animal
16002955|NCT02866864|Other|Animal allergy -|Allergic symptom does not occur when subject contact animal
16002956|NCT02866851|Other|Monitoring by Web-application|Patients have to log in a web-application every day (from D5) to indicate their temperature and the presence of gravity sign in case of fever.
16002957|NCT02866838|Drug|Tranexamic acid|intravenous
16002958|NCT02866838|Drug|Saline 0.9%|intravenous
16002959|NCT02866825|Biological|IFX-1|
16002960|NCT02866825|Biological|Placebo|
16002961|NCT02866812|Other|questionnaires assessing the state of fatigue, depression and anxiety|
16002962|NCT02866799|Other|Multi-PAP|Complex intervention based on the ARIADNE principles with two main components: 1) Training of general practitioners and 2) Patient centered clinical interview.
16002963|NCT02866799|Other|Usual care|Patients will receive the usual clinical care based on current clinical practice guidelines.
16002964|NCT02866786|Drug|Metformin|
16002965|NCT02866786|Drug|ethinyl estradiol and cyproterone acetate|Oral Contraceptive Pill
16002966|NCT02866773|Behavioral|PA1: Education sessions, Reminders, Whataps group|"The intervention includes three components:
~Physical activity knowledge enhancement session: one core session and one booster session on increasing physical activity and reducing sedentary behavior
~Physical activity Anti-inertia Reminder: souvenirs and electronic healthy messages are sent to participants in this group to promote the awareness of performing regular exercise
~Physical activity ambassadors' electronic communication group: the community leaders and ambassadors' formed an electronic communication group to share their experience on performing regular physical activity and program implementation."
16002967|NCT02866773|Behavioral|PA2: Education sessions, Reminders|"The intervention includes two components:
~Physical activity knowledge enhancement session: one core session and one booster session on increasing physical activity and reducing sedentary behavior
~Physical activity Anti-inertia Reminder: souvenirs and electronic healthy messages are sent to participants in this group to promote the awareness of performing regular exercise"
16002968|NCT02866773|Behavioral|PA3: Education sessions, Whataps group|"The intervention includes two components:
~Physical activity knowledge enhancement session: one core session and one booster session on increasing physical activity and reducing sedentary behavior.
~Physical activity ambassadors' electronic communication group: the community leaders and ambassadors' formed an electronic communication group to share their experience on performing regular physical activity and program implementation."
16002969|NCT02866773|Behavioral|PA4: Education sessions|"The intervention includes one component only:
~- Physical activity knowledge enhancement session: one core session and one booster session on increasing physical activity and reducing sedentary behavior"
16002970|NCT02866773|Behavioral|HD1: Education sessions, Reminders, Whataps group|"The intervention includes two components:
~- Healthy diet knowledge enhancement session: one core session and one booster session on increasing reducing sugary intake.
~Healthy diet Anti-inertia Reminder: souvenirs and electronic healthy messages are sent to participants in this group to promote the awareness of reducing sugary intake.
~- Healthy diet ambassadors' electronic communication group: the community leaders and ambassadors' formed an electronic communication group to share their experience on reducing sugary intake and program implementation."
16002971|NCT02866773|Behavioral|HD2: Education sessions, Reminders|"The intervention includes two components:
~Healthy diet knowledge enhancement session: one core session and one booster session on increasing reducing sugary intake.
~Healthy diet Anti-inertia Reminder: souvenirs and electronic healthy messages are sent to participants in this group to promote the awareness of reducing sugary intake."
16002972|NCT02866773|Behavioral|HD3:Education sessions, Whataps group|"The intervention includes two components:
~Healthy diet knowledge enhancement session: one core session and one booster session on increasing reducing sugary intake.
~Healthy diet ambassadors' electronic communication group: the community leaders and ambassadors' formed an electronic communication group to share their experience on reducing sugary intake and program implementation."
16002973|NCT02866773|Behavioral|HD4: Education sessions|"The intervention includes one component only:
~- Healthy diet knowledge enhancement session: one core session and one booster session on increasing reducing sugary intake."
16002974|NCT02866747|Radiation|Hypofractionated stereotactic radiation therapy|
16002975|NCT02866747|Drug|Durvalumab|
16002976|NCT02866734|Other|Free screening group|The intervention provide Diabetic Retinopathy screening without charging a fee.
16002977|NCT02866734|Other|Pay screening group ($150)|The intervention is charging HK$150 for the Diabetic Retinopathy screening.
16002978|NCT02866734|Other|Pay screening group ($300)|The intervention is charging HK$300 for the Diabetic Retinopathy screening.
16003060|NCT02866175|Drug|Vitamin K antagonist|VKA once-daily dosing for target international normalized ratio between 2.0 and 3.0, inclusive
16002979|NCT02866721|Biological|Mesenchymal Stem Cells|"A single dose, one time infusion (in the vein) of one of the following doses of hMSCs: 1 x 10^6, 3 x 10^6 or 5 x 10^6 hMSCs/kg body weight during Visit 2. A traditional 3+3 design will be utilized.
~Allogeneic MSCs will be derived from bone marrow aspirates from a healthy donor whose serum tests negative for cytomegalovirus (CMV) antibodies. Healthy donors will undergo tests for infectious disease and screening for 41 common CFTR mutations. In addition, the MSCs will be validated for in vitro and in vivo efficacy and potency using the in vivo murine pre-clinical model of CF lung infection and inflammation."
16002980|NCT02866708|Device|Intermittent negative pressure device|This intervention study will be designed as a randomized cross-over study.
16002981|NCT02866695|Drug|ingenol mebutate gel 0.015%|ingenol mebutate gel 0.015% to be applied on treatment area
16002982|NCT02866682|Drug|Prograf|Brand Drug for the duration of the study.
16002983|NCT02866682|Drug|Tacrolimus|Generic
16002984|NCT02866669|Behavioral|Practice Facilitation|ractices that are randomized to the practice facilitation arm will work with a practice facilitator that will help practice staff for 15 months to make practice level changes to improve hypertension control. Practice facilitation is a highly customized, staged approach to helping a practice to implement process and structural changes to enhance the quality of care and improve patient and staff satisfaction
16002985|NCT02866669|Behavioral|Peer Coach|Participants enrolled from practices that are randomized to the peer coach arm will be matched with peer advisors who will work with the participants for 12 months.
16002986|NCT02866669|Behavioral|Enhanced usual care|Practices in the usual enhanced care arm will receive a blood pressure medication algorithm developed using national guidelines and content experts on our study team. Practices will be provided the Joint National Committee (JNC) recommended protocol to measuring blood pressures. Practices will receive a laptop workstation that has access to the Patient Activated Learning System - an online education video system.
16002987|NCT02866656|Other|Conventional conservative treatment|Treatment last for 4 weeks, three times a week,
16002988|NCT02866656|Device|therapeutic ultrasound|Treatment last for 4 weeks, three times a week, stimulation was given 8 minutes every time, location of treatment were lower limb ischemia area and its surrounding tissues；
16002989|NCT02866643|Drug|Etonogestrel-Immediate|The investigational intervention will be to insert the contraceptive implant immediately postpartum in the delivery room insertion (0-2 hours following delivery).
16002990|NCT02866643|Drug|Etonogestrel-Delayed|The investigational intervention will be to insert the contraceptive implant 24-48 hours following delivery.
16002991|NCT02866630|Biological|Blood samples|Six additional blood samples will be taken from in-situ catheters during heart surgery
16002992|NCT02866617|Device|Vacuum Formed Thermoplastic Retainers Constructed On 3D Reconstructed Orthodontic Study Model|
16002993|NCT02866604|Procedure|Sterofundin|
16002994|NCT02866604|Procedure|0.9% saline|
16002995|NCT02866591|Other|mammography according to an auto-compression procedure|
16002996|NCT02866591|Other|mammography according to a standard procedure|
16002997|NCT02866591|Other|questionary|
16002998|NCT02866578|Procedure|Open lung protective ventilation strategy|
16002999|NCT02866565|Drug|adipose-derived regenerative cells (ADRCs)|
16003000|NCT02866552|Drug|Stromal Vascular fraction|
16003001|NCT02866552|Drug|Ringer lactate|
16003002|NCT02866539|Drug|Polyherbal capsule coccinia, bougainvillea, catharanthus|A unique combination of 3 herbs that lower blood sugars
16003003|NCT02866539|Drug|Placebo|Similar looking inactive powder
16003004|NCT02866526|Other|Patient questionnaire|quantitative and qualitative data collection will be proposed.
16003005|NCT02866513|Other|evaluate the variations of transpulmonary pressure during the use of APRV by clinicians.|
16003006|NCT02866500|Behavioral|Quality of life survey/ dental statement|Assessment of oral state and patients quality of life before radiotherapy and along treatment for oral cancer
16003007|NCT02866487|Procedure|Bronchoscopy|A diagnostic bronchoscopy will be conducted for clinical indications in children referred to the University of Virginia Children's Hospital for evaluation of respiratory symptoms
16003008|NCT02866474|Dietary Supplement|population living at home with meals on wheels|
16003009|NCT02866474|Dietary Supplement|population living in an EHPAD|
16003010|NCT02866461|Other|No treatment|Observation
16003011|NCT02866448|Drug|Vehicle control|Described in arm
16003012|NCT02866448|Drug|Isoquercetin|Described in arm
16003013|NCT02866448|Drug|Aspirin|Described in arm
16003014|NCT02866448|Drug|Isoquercetin plus Aspirin|Described in arm
16003015|NCT02866435|Drug|Insulin|In each clamp, a small intravenous catheter is placed in participant's arm for infusion of insulin together with potassium phosphate and glucose. Insulin is a hormone that body makes naturally and it causes blood sugar to decrease. Insulin (and glucose) will be infused in calculated doses to maintain blood sugar level in the target range of 95 mg/dl or 50 mg/dl depending on the clamp.
16003016|NCT02866435|Drug|Glucose|Glucose is administered together with insulin and potassium phosphate during each clamp via the intravenous catheter. Glucose is a sugar and it is used to carefully regulate blood sugar level.
16003017|NCT02866435|Drug|Potassium phosphate|Potassium phosphate is administered together with glucose and insulin during each clamp via the intravenous catheter. Potassium is a salt-like substance that is present in the blood.
16003018|NCT02866422|Other|No Intervention|Observational Study: No intervention
16003019|NCT02866409|Procedure|scalp block|"In this group following nerves were blocked-
~Supra-orbital nerve
~Supra-trochlear nerve
~Zygomatico-temporal nerve
~Auriculo-temporal nerve
~Posterior auricular branches of the greater auricular Nerve
~The greater, lesser, and third occipital nerves"
16003020|NCT02866409|Procedure|infiltration|The incision site was infiltrated with drug. {1/3rd in the muscle and 2/3rd in the subcutaneous tissue}.
16003021|NCT02866409|Drug|Dexmedetomidine|Dexmedetomidine was administered as a dose of 1 µg/kg in 20 ml 0.25% bupivacaine for scalp block or infiltration.
16003022|NCT02866409|Drug|Bupivacaine|20 ml of Bupivacaine 0.25% was administered to the patients either in the form of scalp block or infiltration
16003061|NCT02866162|Genetic|High-throughput exome sequencing|
16003062|NCT02866149|Biological|Blood sampling|Up to 5 blood samplings can be performed at different time points
16071133|NCT02374567|Drug|Zolpidem|
16003023|NCT02866396|Drug|Pregabalin|Pregabalin continued at the same preoperative dose 1h before surgery associated to paracetamol 1g PO and ketoprofen 100mg PO Intraoperative: nefopam 20mg IV + ketamine 0.3mg/kg IV + dexamethasone 8mg IV Postoperative: morphine titration in PACU (NRS > 3) + paracetamol 1g/6h PO + ketoprofen 100mg/12h PO systematically, oxycodone 5-10mg/12h PO if NRS>3
16003024|NCT02866396|Other|Naive patient|Pregabalin 150mg PO initiated 1h before surgery Associated to paracetamol 1g PO and ketoprofen 100mg PO Intraoperative: nefopam 20mg IV + ketamine 0.3mg/kg IV + dexamethasone 8mg IV Postoperative: morphine titration in PACU (NRS > 3) + paracetamol 1g/6h PO + ketoprofen 100mg/12h PO systematically, oxycodone 5-10mg/12h PO if NRS>3
16003025|NCT02866383|Drug|Nivolumab|3 mg/kg is given over 60 minutes I.V. on day 1 just after radiation and then every 2 weeks (q2w)
16003026|NCT02866383|Drug|Ipilimumab|1 mg/kg is given over 90 minutes I.V. on day 1 30 minutes after the completion of nivolumab infusion and then every 6 weeks IV (q6w)
16003027|NCT02866383|Radiation|Radiotherapy|15 Gy x 1 fraction given on day 1
16003028|NCT02866370|Drug|Nintedanib|Nintedanib (BIBF1120) 200mg twice daily PO, continuously, until progression or withdrawal from the treatment.
16003029|NCT02866370|Drug|Paclitaxel|"Ovarian Cancer Patients Paclitaxel (80mg/m2) IV Day 1, 8, 15 every 28 days* Endometrial Cancer Patients Carboplatin (AUC 5) and Paclitaxel (175mg/m2) IV every 21 days*
~* Patients will usually receive up to 6 cycles of chemotherapy. If in the opinion of the Investigator, a patient would benefit from continuing with chemotherapy beyond 6 cycles, it is acceptable to continue until progression or unacceptable toxicity."
16003030|NCT02866370|Drug|Pegylated Liposomal Doxorubicin (PLD)|"Ovarian Cancer Patients Pegylated Liposomal Doxorubicin (PLD) (40mg/m2) IV every 28 days*
~* Patients will usually receive up to 6 cycles of chemotherapy. If in the opinion of the Investigator, a patient would benefit from continuing with chemotherapy beyond 6 cycles, it is acceptable to continue until progression or unacceptable toxicity. The maximal lifetime cumulative dose of doxorubicin or pegylated liposomal doxorubicin allowed is 450 mg/m2."
16003031|NCT02866370|Drug|Topotecan|"Ovarian Cancer Patients Topotecan 4mg/m2 IV Day 1, 8, 15 every 28 days*
~* Patients will usually receive up to 6 cycles of chemotherapy. If in the opinion of the Investigator, a patient would benefit from continuing with chemotherapy beyond 6 cycles, it is acceptable to continue until progression or unacceptable toxicity."
16003032|NCT02866370|Drug|Carboplatin|"Endometrial Cancer Patients Carboplatin (AUC 5) and Paclitaxel (175mg/m2) IV every 21 days*
~* Patients will usually receive up to 6 cycles of chemotherapy. If in the opinion of the Investigator, a patient would benefit from continuing with chemotherapy beyond 6 cycles, it is acceptable to continue until progression or unacceptable toxicity."
16003033|NCT02866370|Drug|Doxorubicin|"Endometrial Cancer Patients Doxorubicin IV 60mg/m2 every 21 days*
~* Patients will usually receive up to 6 cycles of chemotherapy. If in the opinion of the Investigator, a patient would benefit from continuing with chemotherapy beyond 6 cycles, it is acceptable to continue until progression or unacceptable toxicity. The maximal lifetime cumulative dose of doxorubicin or pegylated liposomal doxorubicin allowed is 450 mg/m2."
16003034|NCT02866357|Other|No intervention|Just collection of nasopharyngeal aspirate for assessment
16003035|NCT02866344|Procedure|Microwave ablation|Laparoscopic or robot-assisted laparoscopic microwave ablation of cancerous lesions with a 2.45-GHz microwave generator and a 1.8-mm-diameter transcutaneous antenna.
16003036|NCT02866344|Procedure|Hepatic resection|Laparoscopic or robot-assisted laparoscopic surgical resection of cancerous lesions.
16003037|NCT02866331|Drug|G-CSF (Leucostim)|
16003038|NCT02866331|Biological|CB (autologous cord blood)|
16003039|NCT02866331|Drug|Placebo (Normal saline)|
16003040|NCT02866318|Device|Echocardiography|
16003041|NCT02866305|Procedure|VATS bullectomy and mechanical pleuradesis.|Thoracoscopic bullectomy is performed on all visible bullae, alternatively is no visible bullae, the apex is resected. Then mechanical pleuradesis is performed.
16003042|NCT02866305|Procedure|Chest tube insertion|Conventional chest tube insertion.
16003043|NCT02866305|Drug|Epidural|All surgical participants received an epidural prior to the procedure.The epidural was removed simultaneous with the the chest tube.
16003044|NCT02866305|Radiation|High-resolution Computer Tomography|All participants included in this study had a HRCT performed.
16003045|NCT02866292|Other|Pelvic floor muscle and sexual function evaluation|"PFM evaluation was performed by vaginal palpation and vaginal squeeze pressure. During vaginal palpation the physiotherapist introduced the index and middle fingers about 4cm inside the vagina, and requested to hold the maximum contraction of the PFM. Muscle function was classified by the Oxford Scale Modified.
~The vaginal squeeze pressure was measured through Perineometer.To obtain the measurements, the subjects remained positioning and vaginal sensor was introduced into the vaginal cavity. The women were oriented and motivated verbally to perform three voluntary maximal contractions sustained for five seconds and one minute interval between them.
~Sexual function was evaluated by the Female Sexual Function Index (FSFI) questionnaire. The questionnaire consists of 19 multiple-choice questions, which involves six sexual response domains: desire, arousal, lubrication, orgasm, satisfaction and pain."
16003046|NCT02866279|Device|Etonogestrel Contraceptive Implant|Women will be randomized to the TIMING of implant placement
16003047|NCT02866266|Other|Retrospective database review|
16003048|NCT02866253|Drug|DHEA|Interventional patients should take DHEA 25mg tid 12weeks before enter the IVF cycle.
16003049|NCT02866240|Device|Cathodal Transcranial Direct Current Stimulation (tDCS).|Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current delivered to the brain area of interest via electrodes on the scalp.
16003050|NCT02866227|Drug|TOL-463|TOL-463 vaginal gel
16003051|NCT02866227|Drug|TOL-463|TOL-463 vaginal insert
16003052|NCT02866214|Drug|Febuxostat|Film Coated Tablets of Donifoxate (Eva Pharma company ) 40mg administered thrice weekly post hemodialysis session
16003053|NCT02866214|Drug|Placebo|"Film Coated Tablets (Placebo) to be administered thrice weekly post hemodialysis session.
~same color, taste , size . Same all ingredients except Febuxostat (Active ingredient) ."
16003054|NCT02866201|Other|Rectal swab|
16003055|NCT02866188|Device|Check pulse with Smart watch on 3 parts of patient's body surface|Check pulse with smart watch on wrist, carotid artery, and eye of patients in shock or cardiac arrest state.
16003056|NCT02866175|Drug|Edoxaban|Edoxaban 60 mg once-daily or 30 mg once-daily in selected subjects
16003057|NCT02866175|Drug|Clopidogrel|Clopidogrel 75 mg once-daily
16003064|NCT02866149|Other|Stool sampling|Up to 5 blood samplings can be performed at different time points
16003065|NCT02866136|Drug|VP16, carboplatin|Systemic treatment : Intravenous injections, 2 cycles (21 days)
16003066|NCT02866136|Drug|Melphalan|intraarterial injections, 3 to 6 cycles (1 month)
16003067|NCT02866136|Drug|VP16, carboplatin, vincristin|Systemic treatment : Intravenous injections, 6 cycles (21 days)
16003068|NCT02866136|Drug|Carboplatin + laser day 1 (chemothermotherapy)|Chemothermotherapy : Intravenous injection by carboplatin and Laser at day 1
16003069|NCT02866136|Device|Laser (local treatment)|
16003070|NCT02866136|Device|cryoapplication (local treatment)|
16003071|NCT02866136|Radiation|I125 radioactive plaques (local treatment)|
16003072|NCT02866136|Drug|intravitreal Melphalan (local treatment)|
16003073|NCT02866123|Other|ultrasonography|
16003074|NCT02866123|Radiation|pulmonary radiography|
16003075|NCT02866110|Behavioral|Neurofeedback|The Blood Oxygenation Level Dependent (BOLD) signal from the amygdala, recorded with functional magnetic resonance imaging, is utilized as a feedback signal to patients.
16003076|NCT02866110|Device|MRI|Echo-planar Imaging of brain BOLD signal
16003077|NCT02866097|Other|mHealth inventory management|Improved stock management of iCCM commodities using the DHIS2 mHealth platform
16003078|NCT02866097|Other|Supportive supervision|Strengthening of supportive supervision using DHIS2
16003079|NCT02866097|Other|ICCM current standard of care|ICCM implementation as per current practice without mHealth interventions
16003080|NCT02866084|Device|Device|"The following parameters will be set for active treatments using the CVS Device:
~A standardized CVS time-varying waveform lasting approximately 19 minutes will be used. Treatments will be administered up to twice daily. The two daily treatments should ideally be separated by at least one hour.
~The waveform schedule will consist of a warm sawtooth delivered to one ear and a cold sawtooth delivered to the other ear. The warm sawtooth will go from body temperature to 42 °C, and the cold sawtooth will go from body temperature to 17 °C. The two waveforms will be delivered simultaneously, but will have different oscillation frequencies."
16003081|NCT02866071|Drug|Ketamine Hydrochloride|50mg IN Ketamine Hydrochloride
16003082|NCT02866071|Drug|Placebo-Comparator|50mg IN Placebo
16003083|NCT02866058|Procedure|Cesarean Section|
16003084|NCT02866045|Procedure|EUS-guided fine needle biopsy|EUS-FNB is performed using a 22 or 25 G core biopsy needle (SharkCore FNB, Medtronic, Fridley, MN) by standard linear EUS-guided technique. The needle tip has six cutting edge surfaces and an opposing bevel to catch tissue as it is sheared off, enabling cohesive units of tissue acquisition with minimal tissue fracturing. 3 separate passes will be done into the lesion. Additional passes may be made if clinically necessary. No suction will be applied on the first pass. If the FNB sample obtained is deemed to be inadequate, negative pressure (using the standard suction syringe) will be applied to the needle on additional passes. The histology and cytology specimens will be processed as per standard clinical care.
16003085|NCT02866045|Procedure|Single incision needle knife biopsy|For patients allocated to the SINK group, after EUS confirmation, the esophagogastroduodenoscopy (EGD) will be repeated to perform the SINK biopsy. Under direct endoscopic visualization, a 10 mm linear incision will be made to the surface of the SEL using a conventional needle-knife sphincterotome with standard blended electrocautery (Endocut mode - ERBE system USA, Marietta, GA). A conventional biopsy forceps will then be introduced through the incision deep into the mass to obtain at least 3 samples. The incision will then be closed using 1 to 3 endoclips for prophylaxis against subsequent bleeding. The biopsies will be placed in formalin as per standard surgical pathology protocol.
16003086|NCT02866032|Drug|MOB015B|
16003087|NCT02866032|Drug|Ciclopirox 80 mg/g|
16003088|NCT02866019|Device|CLS2702C/CLS2702D|CLS2702C (cell sheet) will be transplanted to the wound site using CLS2702D (transplantation device) (screening period, 1 month [4 weeks]; cell sheet culture period, 0.5 month [16 days]; transplantation period, assessment/follow-up period, 6 months [24 weeks])
16003089|NCT02866006|Drug|BVAC-C|Autologous B cells and monocytes transfected with E6E7 gene of HPV
16003090|NCT02866006|Drug|Topotecan|
16003091|NCT02865993|Other|betadine group|Patients intra-operatively received intraperitoneal irrigation prior to abdominal closure with low molecular weight povidone-iodine solution ('Betadine LMW') (PVP-I LMW) diluted 50:50 with normal saline.
16003092|NCT02865993|Other|no betadine group|Patients intra-operatively received intraperitoneal irrigation prior to abdominal closure with only normal saline solution.
16003093|NCT02865980|Other|clove extract|in intervention group, first will be washed the Catheter with Betadine after 2 minutes will be used of the clove extract with 2 ml of scrub for 15 seconds. The incidence of inflammation of vascular access will be assessed in patients on hemodialysis for each patient before starting the process over a period of 2 weeks is equivalent to 6 sessions of hemodialysis.
16003094|NCT02865980|Other|Betadine|in control group, will be washed the Catheter with Betadine
16003095|NCT02865967|Other|Usual care + a-GPS|Clinicians will be provided a-GPS data on a regular basis for intervention group, but not control group such as their risk factors for asthma, quality of care, and asthma outcomes.
16003096|NCT02865967|Other|Usual care|The subjects will be treat for their asthma by their physicians according to usual care.
16003097|NCT02865954|Device|iball (mhealth application)|mhealth application and associated device to support activation of the pelvic floor muscles.
16003098|NCT02865941|Dietary Supplement|Fortification with modular protein|Modular product supplementation is based on most recent breast analysis done for the participant.
16003099|NCT02865941|Dietary Supplement|Fortification with modular carbohydrate|Modular product supplementation is based on most recent breast analysis done for the participant.
16003100|NCT02865941|Dietary Supplement|Fortification with modular fat|Modular product supplementation is based on most recent breast analysis done for the participant.
16003101|NCT02865928|Drug|Bupivicaine HCl|Ultrasound guided serratus plane block with bupivicaine
16003102|NCT02865928|Drug|Normal Saline|Same injection technique as intervention arm with normal saline
16003103|NCT02865915|Drug|MLE4901|For 80% of subjects randomized to MLE4901 (n=24/30), the dose is 40 mg twice daily. Six subjects (20%) randomized to higher MLE4901 dose cohorts that were promptly discontinued.
16003104|NCT02865915|Drug|Placebo|Placebo to match active drug
16004223|NCT02857322|Other|Accompanying patient's specific perioperative|
16003105|NCT02865902|Device|Low-Level Laser Therapy by Ezlase; Biolase®|comparision of the effects of low-level-laser therapy on wound healing of palatal donor site
16003106|NCT02865889|Procedure|Laparoscopy in Gynecologic Oncologic Indications|
16003107|NCT02865889|Procedure|Conventional surgery (abdominal radical surgery)|
16003108|NCT02865876|Procedure|Accelerated Corneal Cross-linking|All participants in this group receiving conventional therapy (moxifloxacin 0,5% for bacterial keratitis or natamycin for mycotic keratitis) plus accelerated cross-linking (Avedro Inc., Waltham, USA) under topical anesthesia using 0.1% riboflavin (Vibex, Avedro Inc, Waltham, USA) for 10 minutes and irradiation 30 mW/cm2 during 3 minutes.
16003109|NCT02865863|Dietary Supplement|Eurycomalongifoliawater extract (Physta®)|
16003110|NCT02865863|Dietary Supplement|Placebo|
16003111|NCT02865863|Dietary Supplement|Multivitamin|
16003112|NCT02865850|Drug|vadadustat|oral tablet
16003113|NCT02865850|Drug|Darbepoetin alfa|subcutaneous/intravenous
16003114|NCT02865837|Other|brachytherapy|"The brachytherapy applicator and a urinary catheter are set up in the operating room under general anesthesia.
~Then, an MRI (or a scanner if contra-indication) is performed after a bladder filling with 120cc of normal saline solution and urinary catheter clamping.
~Right after, a scanner is performed with urinary catheter declamping and emptied bladder.
~Delineation of CTVs and organs at risk (bladder, rectum, sigmoid, small bowel), and dosimetric optimisation are made on study with filled bladder.
~Then, organs at risk are delineated on the study with emptied bladder. The prior dosimetry is reset on this study and organs at risk doses are compared."
16003115|NCT02865824|Drug|Continue thienopyridine|Patients continue dual antiplatelet therapies before colonoscopy. The patients continue taking thienopyridine before colonoscopy
16003116|NCT02865824|Drug|Discontinue thienopyridine|Patients who are taking dual antiplatelet therapies stop thienopyridine one week before they undergo colonoscopy
16003117|NCT02865811|Drug|Pembrolizumab|"Please see Arms for description."
16003118|NCT02865811|Drug|Pegylated Liposomal Doxorubicin (PLD)|"Please see Arms for description."
16003119|NCT02865785|Drug|Intralipid 20%|intralipid D4-9 of induction ovulation to be repeated within 7 days of positive pregnancy test.
16003120|NCT02865785|Drug|Placebo|saline infusion D4-9 of induction of ovulation to be repeated within 7 days of positive pregnancy test.
16003121|NCT02865759|Behavioral|Mindfetalness|The pregnant woman is motivated to practice Mindfetalness verbally, by a brochure and at a website.
16003122|NCT02865746|Drug|Bethametasone|The injections were performed with the aid of syringes fitted with ultrafine needles (BD ultrafine U-100, 0.3 x 8 mm), in the buccal mucosa, submucosally near the tooth's periapex of the periapical region of the tooth involved, by using the submucosal infiltration technique.
16003123|NCT02865746|Drug|Placebo|The injections were performed with the aid of syringes fitted with ultrafine needles (BD ultrafine U-100, 0.3 x 8 mm), in the buccal mucosa, submucosally near the tooth's periapex of the periapical region of the tooth involved, by using the submucosal infiltration technique.
16003124|NCT02865733|Drug|Remodulin|After Fontan operation, the mean pulmonary arterial pressure (mPAP)evaluated by CVP or transpulmonary pressure gradient(TPG) evaluated by Echo will be measured firstly, if the data met the criteria, and the patients were enrolled in the experimental group, the patients would be administrated intravenously of Remodulin® with the beginning of 5ng/kg/min, with the rate of 10ng/kg/min every 30 minutes up to 80ng/kg/min.
16003125|NCT02865733|Drug|distilled water|After Fontan operation, the mPAP (evaluated by CVP) or TPG (evaluated by Echo) will be measured firstly, if the data met the criteria, and the patients were enrolled in placebo group, then the patients would be administrated intravenously of distilled water with the beginning of 0.15ml/hr, with the rate of 0.3ml/hr every 30 minutes up to 2.45ml/hr.
16003126|NCT02865720|Drug|CINRYZE 500 U|IV infusion administered twice weekly
16003127|NCT02865720|Drug|CINRYZE 1000 U|IV infusion administered twice weekly
16003128|NCT02865707|Dietary Supplement|Synergy-1|Synergy-1 is chicory-derived β-fructans inulin plus FOS (1:1).
16003129|NCT02865707|Dietary Supplement|Maltodextrin|Maltodextrin is carbohydrate adsorbed in the small bowel.
16003130|NCT02865694|Other|Cascade|
16003131|NCT02865681|Drug|Menopur|Nasal versus injectable
16003132|NCT02865681|Drug|Synarel|nasal
16003133|NCT02865681|Drug|HCG trigger|injectable
16003134|NCT02865681|Drug|Clomiphene citrate|oral
16003135|NCT02865681|Drug|Letrozole|Oral
16003136|NCT02865668|Drug|Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC]|Participants will receive 1 XR FDC tablet containing canagliflozin 50 mg and metformin 500 mg orally under fed (Treatment B) or fasted (Treatment D) condition in a given treatment period as per treatment sequence.
16003137|NCT02865668|Drug|Canagliflozin|Participants will receive canagliflozin 50 mg oral tablet) under fed (part of treatment A) or fasted (part of treatment C) condition in a given treatment period as per treatment sequence.
16003138|NCT02865668|Drug|Metformin Extended Release (XR)|Participants will receive 1 metformin XR tablet of 500 mg orally under fed (part of treatment A) or fasted (part of treatment C) condition in a given treatment period as per treatment sequence.
16003139|NCT02865655|Procedure|Hysteroscopic|
16003140|NCT02865642|Drug|Serotonin Uptake Inhibitors|
16003141|NCT02865642|Drug|Placebo|
16003142|NCT02865629|Drug|N-acetyl cysteine|N-acetylcysteine will be initiated at 600 mg PO daily for Week 1, then increased to 600 mg PO twice a day for Week 2, then increased to 600 mg PO morning and 1200 mg PO evening for Week 3, and then increased to 1200 mg PO twice a day for Week 4-8. Doses might be decreased anytime if clinically indicated. Following the study, all patients will be referred to treatment as usual. Adherence will be assessed in weekly visits in the first month and then bi-weekly in the second month. Adherence will be assessed by subject interview, pill counts during each study visit, and by legal guardian interview (if minor).
16003143|NCT02865616|Drug|MET-2|Microbial Ecosystem Therapeutics (MET) is a new treatment approach for debilitating recurrent Clostridium difficile infection that has been developed as an alternative to fecal transplantation.
16003144|NCT02865616|Drug|Vancomycin|Patients will be on vancomycin to control symptoms up until the time of the treatment. Patient must hold their p.o. vancomycin for 24 hours prior to receiving the first dose.
16003222|NCT02865044|Other|Wax Ester Marine Oil|Wax ester marine oil (Calanus oil; 4 g providing 260 mg EPA and 156 mg DHA; 8 capsules) consumed once, in clinic, at t=0.
16003145|NCT02865603|Behavioral|PAX Good Behavior Game|PAX GBG includes evidence-based kernels and a classroom game where students are reinforced for their mutual success in withholding inappropriate behavior.
16003146|NCT02865590|Device|sinus lift with Lyophilized Equine Bone Allograft (Bio-gen , Bioteck s.p.a., Arcugnano (VI) - Italy)|
16003147|NCT02865590|Device|Sinus lift with deproteinized bovine bone allograft (Endobon Xenograft Granules, Zimmer Biomet, San Donato Milanese (MI) - Italy)|
16003148|NCT02865564|Dietary Supplement|Lactobacillus reuteri DSM 17938|
16003149|NCT02865564|Dietary Supplement|Placebo|
16003150|NCT02865564|Drug|ampicillin and gentamicin|
16003151|NCT02865551|Device|Foley catheter|Extended bladder catheterization after epidural anesthesia.
16003152|NCT02865551|Device|Short term catheter|Intermittent catheterization every 4 hours after epidural anesthesia.
16003153|NCT02865551|Drug|Epidural anesthesia|Performance of epidural anesthesia by a certified anesthesiologist.
16003154|NCT02865538|Drug|BAY3427080|
16003155|NCT02865538|Drug|Placebo (for BAY3427080)|
16003156|NCT02865512|Procedure|thoracic epidural catheterization|thoracic epidural catheterization for the management of postoperative pain
16003157|NCT02865499|Drug|acarbose|acarbose treatment with meals
16003158|NCT02865486|Dietary Supplement|Lipid emulsion|1 of 4 isovolumetric (200 ml) and isocaloric (380 kcal) lipid emulsions with different acid and shear stability will be ingested on visit 2.
16003159|NCT02865486|Dietary Supplement|Lipid emulsion|1 of 4 isovolumetric (200 ml) and isocaloric (380 kcal) lipid emulsions with different acid and shear stability will be ingested on visit 3.
16003160|NCT02865486|Dietary Supplement|Lipid emulsion|1 of 4 isovolumetric (200 ml) and isocaloric (380 kcal) lipid emulsions with different acid and shear stability will be ingested on visit 4.
16003161|NCT02865473|Drug|Pilocarpine|topical instillation into the study eye
16003162|NCT02865460|Drug|Ubiquinol|Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
16003163|NCT02865460|Drug|Placebo|Take oral tablets as directed (2x200 mg for 2 months; 1x200 mg for 4 months) with food each morning- upon waking
16003164|NCT02865447|Device|total hip arthroplasty implant|PROFEMUR PRESERVE total hip arthroplasty femoral stem
16003165|NCT02865434|Drug|Tc99m-tilmanocept|Tilmanocept is a radiotracer that accumulates in macrophages by binding to a mannose binding receptor that resides on the surface.
16003166|NCT02865434|Procedure|SPECT Imaging (60 Minutes post-injection)|Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 60 Minutes post-injection.
16003167|NCT02865434|Procedure|SPECT Imaging (180 Minutes post-injection)|Subjects enrolled in Groups 1-9 will receive whole body planar SPECT imaging with 3D SPECT or SPECT/CT for targeted joints of interest 180 Minutes post-injection.
16003168|NCT02865434|Procedure|Whole body planar SPECT imaging (15 Minutes post-injection)|Subjects enrolled in Groups 10-11 will receive a whole body planar SPECT scan performed 15 minutes post-injection for dosimetry.
16003169|NCT02865434|Procedure|Whole body planar SPECT imaging (60 Minutes post-injection)|Subjects enrolled in Groups 10-11 will receive a whole body planar SPECT scan performed 60 minutes post-injection for dosimetry.
16003170|NCT02865434|Procedure|Whole body planar SPECT imaging (180 Minutes post-injection)|Subjects enrolled in Groups 10-11 will receive a whole body planar SPECT scan performed 180 minutes post-injection for dosimetry.
16003171|NCT02865434|Procedure|Whole body planar SPECT imaging (18-20 Hours post-injection)|Subjects enrolled in Groups 10-11 will receive a whole body planar SPECT scan performed 18-20 Hours post-injection for dosimetry.
16003172|NCT02865434|Procedure|Blood Collection for PK Testing (15 Mins Before Injection)|Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis within 15 minutes prior to administration of Tc 99m tilmanocept
16003173|NCT02865434|Procedure|Blood Collection for PK Testing (after injection)|Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis immediately following administration of Tc 99m tilmanocept (00:00)
16003174|NCT02865434|Procedure|Blood Collection for PK Testing (15 minutes post injection)|Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis at 15 ± 5 minutes post injection of Tc 99m tilmanocept
16003175|NCT02865434|Procedure|Blood Collection for PK Testing (60 minutes post injection)|Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis at 60 ± 15 minutes post injection of Tc 99m tilmanocept
16003176|NCT02865434|Procedure|Blood Collection for PK Testing (180 minutes post injection)|Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis at 180 ± 15 minutes post injection of Tc 99m tilmanocept
16003177|NCT02865434|Procedure|Blood Collection for PK Testing (18-20 hours post injection)|Blood will be collected for subjects enrolled in Groups 10-11 for the purpose of PK analysis at 18-20 hours post injection of Tc 99m tilmanocept
16003178|NCT02865434|Procedure|Planar Image with both Hands in Field of View|Subjects in Groups 1-9 and Groups 10 and 11 will receive planar imaging with both hands in the field of view at 60 and 180 minutes post-injection.
16003179|NCT02865421|Drug|stem cells|adipose tissue derived stromal vascular fraction
16003180|NCT02865421|Drug|platelet rich plasma|platelet rich plasma transplanted in bald area at a distance
16003181|NCT02865408|Dietary Supplement|Peptamen 1.5% via enteral|Study patients in this group will be prescribed 1.0 g/kg/d of protein using standard enteral Peptamen 1.5%. Based on current compliance or tolerance statistics, investigators expect patients to only receive 50-60% of these prescribed doses; effective protein intake will therefore be approximately 0.5-0.6 g/kg/d.
16003182|NCT02865408|Dietary Supplement|Prosol 20% IV to 1.75g/kg/day|Patients in group 2 will receive Peptamen 1.5% but in addition, will receive sufficient intravenous amino acid supplements (Prosol 20%) to achieve an effective fixed dose of 1.75 g/kg/day.
16003183|NCT02865408|Dietary Supplement|Prosol 20% IV to 2.5g/kg/day|Patients in this group will receive intravenous amino acids, Prosol 20% in addition to standard enteral Peptamen 1.5% to achieve an effective protein intake of 2.5 g/kg/d.
16003184|NCT02865395|Drug|Belladonna and Opium Suppository|
16003185|NCT02865395|Procedure|Rectal Exam|
16003186|NCT02865382|Procedure|white light was used for colonoscopy withdrawal|
16003187|NCT02865382|Procedure|OE mode was used for colonoscopy withdrawal|
16003188|NCT02865369|Drug|Daclatasvir and Asunaprevir|Daclatasvir and Asunaprevir combined treatment will not be assigned to the enrolled patients, but the patients who are treated with Daclatasvir and Asunaprevir will be included in this observational study.
16003189|NCT02865356|Drug|Cyclosporine 5% solution|topical solution
16003190|NCT02865356|Drug|Placebo|topical vehicle solution
16003191|NCT02865343|Device|Non-invasive Ventilation(NIV)|The ventilator will be set in spontaneous mode with a ramp to reach a minimal pressure of 12 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.
16003192|NCT02865343|Device|Sham Non-invasive ventilation(NIV)|The ventilator will be set in spontaneous mode with a ramp to reach a maximal pressure of 5 centimeters of water (cmH2O) during inspiration and 3 cmH2O during expiration.
16003193|NCT02865330|Other|Registry|National Registry of patients with prostate cancer as monitored through active surveillance, with the intention of testing the hypothesis that cancer-specific mortality in very low-risk and low-risk patients is less than 5% at 15 years.
16003194|NCT02865304|Drug|endostar|
16003195|NCT02865291|Device|ForConti device|
16003196|NCT02865278|Other|Standard meal|The participants consume the drink, experimental or placebo drink. After 3 hours they consume a standard meal (905 kcal, 15% protein, 46% fat, 39% CHO). Blood samples are taken at fasting, over 3 hours after drink consumption and over 5 hours after the test meal to evaluate metabolic response. Fasting and 48h-urine are collected to evaluate bioavailability of polyphenol.
16003197|NCT02865265|Procedure|Pecs II and parasternal blocks|"Pecs II block was performed at the level of the fourth rib in the fascial plane between the minor pectoral and serratus anterior muscles, and 20 ml of 0.5% levobupivacaine solution were injected.
~An ultrasound-guided ipsilateral parasternal block was performed via two separate injections of 4 ml of 0.375% levobupivacaine at the level of the 2nd and 4th intercostal space underneath the external intercostal membrane between the major pectoral and intercostal muscles close to the surface of the 2nd and 4th rib."
16003198|NCT02865252|Other|MWM Treatment|
16003199|NCT02865252|Other|MWM Sham|
16003200|NCT02865239|Procedure|Position for the 3.0 Tesla in Magnetic Resonance Imaging|"Eligible patients will have a standard MRI in prone position. At the end of this examination, all patients will have an other standard MRI in supine position.
~This examination is then extended by 10 minutes without additional injection of contrast medium"
16003201|NCT02865226|Other|paravertebral block by the anesthetist before incision (paravertebral block guided by ultrasound)|
16003202|NCT02865226|Other|paravertebral block by the thoracic surgeon at chest closure (paravertebral block visual).|
16003203|NCT02865213|Device|OBA|"The intrusion of posterior teeth using removable appliance OBA."
16003204|NCT02865213|Device|Miniplates|"The intrusion of posterior teeth using temporary anchorage Miniplates."
16003205|NCT02865213|Device|Miniscrews|"The intrusion of posterior teeth using temporary anchorage Miniscrews."
16003206|NCT02865200|Other|Dry Needling Application|Dry needling was performed on active and/or latent TPs at Gluteus Medius, Quadratus Lumborum, Multifidus, Erector Spinae muscles of the subjects in the study groups without applying any local anesthetic substance. The needles were applied with a 90º angle for Multifidus, Quadratus Lumborum and Gluteus Medius muscles; while they were applied with a 45º angle for Erector Spinae muscles. Thin stainless steel needles of 0.25x0.40 mm and 0.30x0.60 mm were applied in infiltration form on the TP through many points in conformity with the injection technique.
16003207|NCT02865200|Other|Classic Physiotherapy Program|"Hot-pack was applied for 20 minutes. Burst TENS was applied on the lumbar regions of the cases of the control group paravertebrally with 4-electrode reusable silicone rubber. The dimensions of electrode is 5x5cm. Pulse width was set for 100 µsn, pulse frequency was set for 2 Hz, cycle time is set for 0.5 seconds and the amplitude was increased until visible muscle contraction was reached. If the muscle contraction is lost during the session, the amplitude was increased again.
~Ultrasound was paravertebrally applied to the lower back regions of the subjects. The treatment was applied with 1 MHz frequency, 1.5 W/cm2 power, for 6 minutes a day, for 10 sessions in total with direct contact with the patient's skin."
16003208|NCT02865187|Dietary Supplement|Vitamin D|Vitamin D 600IU/day
16003209|NCT02865187|Drug|Hormonal contraception|Hormonal contraceptives
16003210|NCT02865174|Drug|Topical tranexamic acid|Intraarticular application of tranexamic acid 3g in 100 ml normal saline into knee joint after closure of the joint capsule
16003211|NCT02865174|Drug|Floseal®|Floseal® (Hemostatic matrix, 10ml, Baxter) was applied on potential bleeding sites: the femoral insertion of the posterior cruciate ligament, the lateral genicular artery after resection of the meniscus, the posterior capsule of the knee joint, the bony surfaces not covered by the implant as well as the pinholes (femur and tibia). The entire content of a 10 mL vial containing the active product (Floseal®) was used. The HM remained in place for 3 minutes and was then gently rinsed from the knee as recommended by the manufacturer (Baxter)
16003212|NCT02865174|Drug|Enoxaparin|Enoxaparin will be administrated sc 40mg each day postoperatively as venous thromboembolism prophylaxis in the duration of hospital stay
16003213|NCT02865161|Drug|NISELAT|NISELAT 600MG BD
16003214|NCT02865148|Behavioral|Cognitive behavioral therapy|CBT-based protocol tailored to advanced breast cancer patients with a focus on managing a broad array of symptoms including psychological distress, pain, and fatigue. Important features of the protocol are: 1) a unique motivational interviewing component in the first session that will focus on patients' motivation for engaging in the protocol, confidence (i.e., self-efficacy) to learn new strategies, and potential barriers to adopting recommendations for lifestyle change; and 2) protocol that targets multiple symptoms, and 3) adapted to meet the unique needs of advanced breast cancer patients.
16003215|NCT02865135|Drug|DPX-E7 vaccine|Therapeutic vaccine for the treatment of incurable HPV16-related oropharyngeal, cervical and anal cancer in HLA-A*02 positive patients.
16003216|NCT02865122|Drug|NTRA-9620|Oral daily dose
16003217|NCT02865122|Drug|Placebo|Oral daily dose
16003218|NCT02865109|Drug|Nusinersen|Administered by intrathecal injection
16003219|NCT02865083|Device|Traxi Pannus Retractor|traxi® Panniculus Retractor is a retraction device used for retraction of the panniculus during surgical procedures. traxi retracts and holds the panniculus for the duration of the operation, freeing the surgeons hands and those of the staff to better care for the patient.
16003220|NCT02865070|Device|Skin Sensor|Wireless vitals monitor
16003221|NCT02865057|Procedure|Vaginal assessment|Vaginal assessment of position prior to delivery
16003223|NCT02865044|Other|Ethyl Ester Marine Oil|Ethyl ester (EE) marine oil (Lovaza OM3 EE; 1 g providing 465 mg EPA and 375 mg DHA; 1 capsule), consumed once, in clinic, at t=0
16003224|NCT02865031|Drug|Decorin|Intravitreal Injection following ocular trauma to prevent scar tissue formation.
16003225|NCT02865018|Drug|cetirizine|
16003226|NCT02865005|Drug|Dapsone 5.0% Gel (SEEGPharm)|Topical Gel
16003227|NCT02865005|Other|Placebo|Topical Gel
16003228|NCT02865005|Drug|Dapsone 5.0% Gel (Allergan)|Topical Gel
16003229|NCT02864992|Drug|Tepotinib|Subjects will receive 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
16003230|NCT02864966|Device|Condom|This study involves testing a condom, however the device will not be used as intended. The device will be destroyed to make the test patches required for this safety study.
16003231|NCT02864953|Drug|BIIB093|Administered as specified in the treatment arm.
16003232|NCT02864953|Drug|Placebo|Administered as specified in the treatment arm.
16003233|NCT02864940|Device|Lumosity|A web-based cognitive training platform that includes games designed with the purpose of improving the user's cognitive abilities
16003234|NCT02864940|Device|Crossword puzzle|This game offers a choice between three puzzle sizes, three levels of complexity, and varying font sizes. It also includes optional help features such as filling in an unknown letter or word.
16003235|NCT02864927|Biological|Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine|0.5 mL, Intramuscular. 2 doses 3 months apart
16003236|NCT02864927|Biological|Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine|0.5 mL, Intramuscular
16003239|NCT02864901|Drug|KSL-W|Plaque reducing gum
16003240|NCT02864901|Drug|Chewing Gum Placebo|
16003241|NCT02864888|Radiation|Radiation|Children with a diffuse, intrinsic brain stem glioma will receive radiation.
16003242|NCT02864888|Drug|Atengenal|Children with a diffuse, intrinsic brain stem glioma will receive Atengenal in combination with Astugenal (Antineoplaston therapy) and radiation
16003243|NCT02864888|Drug|Astugenal|Children with a diffuse, intrinsic brain stem glioma will receive Astugenal in combination with Atengenal (Antineoplaston therapy) and radiation
16003244|NCT02864875|Drug|Fibrinogen concentrate|Receive fibrinogen concentrate 50mg/kg of body weight after randomization
16003245|NCT02864862|Device|Immediate implant|
16003246|NCT02864862|Biological|SCTG|
16003247|NCT02864862|Biological|ADM|
16003248|NCT02864849|Drug|Oxaliplatin|
16003249|NCT02864849|Drug|Capecitabine|
16003250|NCT02864849|Radiation|Intensity modulated radiotherapy|
16003251|NCT02864849|Procedure|Total mesorectal excision|
16003252|NCT02864836|Procedure|Samples collection|5 samples collected for each patient (tumor biopsy, healthy tissue around the tumor, blood, urine and saliva), quantification of isotopes, measure of mRNA expression of proteins 4 samples for each patient (healthy tissue, blood, urine and saliva), quantification of isotopes, measure of mRNA expression of proteins
16003253|NCT02864823|Procedure|Perichondrium Autografts|Perichondrium tissue was harvested from the patient's ear cartilage and transplanted to reconstruct the scleral defect.
16003254|NCT02864810|Drug|[18F]GP1|[18F]GP1 PET/CT imaging for detecting thromboembolism
16003255|NCT02864797|Other|Health related quality of life collected via CHES|Health related quality of life (QoL) is collected at each follow-up visit using tablets computer and CHES software. Thus, QoL's results are directly presented to clinicians via the CHES, in order to be considered as part of the supportive care strategy at the end of the study
16003256|NCT02864784|Drug|Amorphous calcium carbonate|Subjects in this arm of the study will receive standard treatment with ZA or Denosumab (4 mg once every 4 weeks for ZA and 120mg (1.7ml injection) every 4 weeks for Denosumab) as well as AMOR-1 tablets, containing 200 mg elemental calcium per tablet, individually titrated up to the maximum level which does not induce grade 2 hypercalcemia.
16003257|NCT02864784|Other|Placebo|
16003258|NCT02864758|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Tablets, 20mg once daily
16003259|NCT02864758|Drug|Vitamin K antagonists|Tablets, dose is based on International Normalized Ratio
16003260|NCT02864758|Drug|dabigatran (Pradaxa)|Tablets, 150 mg twice daily
16003261|NCT02864745|Device|functional electrical stimulation-assisted cycle ergometry|Early intensive rehabilitation protocol, which includes the use of functional electrical stimulation-assisted cycle ergometry
16003262|NCT02864745|Other|standard rehabilitation|This group will receive standard rehabilitation, which will be monitored, but not protocolised.
16003263|NCT02864732|Other|Rehabilitation exercises|
16003264|NCT02864732|Device|Electrical Stimulation|
16003265|NCT02864719|Other|Energy Conservation+Problem Solving Therapy|The intervention was delivered by telephone. Each EC+PST intervention session was planned to last approximately 45 minutes and occur twice a week for up to 4 weeks. Sessions terminated when the participants identified and solved two fatigue-related problems of their choice or had participated in the intervention for eight sessions. A Participant Workbook was used throughout the intervention. During eight intervention sessions, participants identified two fatigue-related problems and solutions for them, implemented the solution plans, and reviewed the implementations.
16003266|NCT02864706|Drug|Everolimus|"All patients, independent of their initial randomization in the core study, were followed up as in one single group
~Commercially available everolimus (Certican®), oral route, was used."
16003267|NCT02864706|Drug|Cyclosporine|Cyclosporine (CsA) control group target blood level: 150-350 ng/mL (month 1-3); 100-250 ng/mL (month 4-6); 60-200 ng/mL (month 7-12); everolimus group target blood level: 75-175 ng/mL (month 1-3)
16003268|NCT02864706|Drug|Mycophenolate mofetil|Mycophenolate mofetil (MMF) target dose for control group: 2000-3000 mg/day everolimus group target dose: 1500-2000 mg/day and 75-175 ng/mL after week 11
16003269|NCT02864706|Drug|Corticosteroids|Corticosteroids (CS) initiated at 0.2-0.5 mg/kg/day. Tapered to no less than 0.1 mg/kg at Month 3 for control and everolimus groups.
16003270|NCT02864693|Device|Kinnex|The Kinnex is a microprocessor controlled hydraulic ankle foot device (Freedom Innovations, Irvine, CA).
16003301|NCT02864511|Procedure|Nefertiti lift|
16003302|NCT02864498|Drug|DS107|
16003271|NCT02864693|Device|Pacifica LP|The Pacifica LP is a carbon-fiber ankle foot device (Freedom Innovations, Irvine, CA)
16003272|NCT02864680|Other|Electroretinography|
16003273|NCT02864680|Other|Contrast sensitivity test during Electroencephalography|Stimuli are black and white grids, having different range of spatial frequencies, presented with different contrasts on a grey background thanks to a computer monitor, in a dark room. Participants are requested to maintain central fixation. During the test patients stay sit, head hold by chin strap. A pause can be asked by participant and done at every moment. This test lasts approximately 30 minutes.
16003274|NCT02864680|Other|Visual simultaneity test during Electroencephalography|Two vertical bars are showed on a monitor, on the link and right of point of central fixation. Bars appear simultaneously or with a 10 to 200 ms asynchrony. Participants must determine whether stimuli are simultaneous or asynchronous and answer pressing the link button for simultaneity or right button for asynchrony. During the test patients stay sit, head hold by chin strap. A pause can be asked by participant and done at every moment. This test lasts approximately 30 minutes.
16003275|NCT02864680|Other|Face perception test during Electroencephalography|Faces filtered in different spatial frequence ranges are showed randomly on a monitor, in a dark room. Participants must maintain a central fixation thank to a fixation cross. During the test patients stay sit, head hold by chin strap. A pause can be asked by participant and done at every moment. This test lasts approximately 30 minutes.
16003276|NCT02864680|Other|CAST (cannabis abuse screening test)|
16003277|NCT02864680|Other|PANSS (Positive And Negative Symptoms Scale) test|
16003278|NCT02864680|Other|Delayed Matching to Sample (DMS) test|
16003279|NCT02864680|Other|Spatial Working Memory (SWM) test|
16003280|NCT02864680|Other|Rapid Visual Information Processing (RVP) test|
16003281|NCT02864680|Other|Test for attentional performance (TAP) / Divided Attention|
16003282|NCT02864680|Other|Collection of saliva sample|In case of specific consent of participant to ancillary study, for ancillary study
16003283|NCT02864654|Procedure|ADRC injection|10 mL of autologous ADRC suspension will be injected intramuscularly
16003284|NCT02864654|Other|ADRC isolation|ADRC will be isolated according to patent pending technology based on enzymatic digestion, washing and concentration of cell pellet in 10 ml of normal saline.
16003285|NCT02864654|Procedure|Liposuction|
16003286|NCT02864641|Behavioral|Planet K|Planet K is a mobile and web-based technology infrastructure specifically designed to (a) enhance youths' chronic kidney disease- and treatment-related knowledge through interactive and game-based educational materials; (b) support adherence to the treatment regimen through customized task prompts via mobile and web-based delivery; and (c) promote patient-provider communication through real-world data collection and feedback loops.
16003287|NCT02864628|Biological|MVA-BN-RSV|MVA-mBN294B
16003288|NCT02864628|Other|Placebo|Tris Buffered Saline
16003289|NCT02864615|Radiation|SBRT|Dose and schedule will be depended on metastases location.
16003290|NCT02864602|Drug|IV dexamethasone|An infusion of IV dexamethasone
16003291|NCT02864589|Behavioral|Internet-delivered habit reversal training|The I-HRT group will receive a 10-week therapist-guided, parent-assisted, Internet-delivered behavioural treatment. The treatment is based on existing literature on habit reversal training (i.e. Woods, D.W. (2008). Managing Tourette syndrome: A behavioral intervention for children and adults therapist guide. OUP, USA.) with added interactive features as videos and illustrations. In short, the participants practice to become more aware of their tics and inhibit them by performing competing responses (movements). The treatment is therapist guided: the participants have regular (up to 5 days a week) contact with a personally assigned therapist via written text in the platform and occasionally via the telephone. The children and parents have separate logins and access partly different content.
16003292|NCT02864589|Behavioral|Internet-delivered exposure and response prevention|The I-ERP group receives a 10-week therapist-guided, parent-assisted, Internet-delivered behavioural treatment. The treatment is based on existing literature on exposure and response prevention (i.e. Verdellen, C. et al. (2011). Tics: Therapist manual & workbook for children. Boom, Amsterd.) with added interactive features as videos and illustrations. In short, the participants practice to suppress their tics for longer and longer times, at the same time as premonitory urges are intentionally provoked. The treatment is therapist-guided: the children and parents have regular (up to 5 days a week) contact with a personally assigned therapist via written text in the platform and occasionally via the telephone. The children and parents have separate logins and access partly different content.
16003293|NCT02864576|Behavioral|Cognitive Remediation_Aerobic Exercise|"Cognitive Remediation:
~The REHACOP program consists of: Attention unit training sustained, selective, alternant and divided attention; Memory unit focusing on visual and verbal learning, recall and recognizing memory; Language unit including grammar, syntax, vocabulary, verbal fluency, verbal comprehension, abstract language; Executive functions unit training cognitive planning, proverbs, analogies; and Social cognition unit exercising theory of mind, social reasoning and moral dilemmas.
~Aerobic Exercise:
~12 weeks of systematic aerobic exercise program. Patients will walk with a moderate intensity 10 minutes the first week and will increase gradually up to 30 minutes-walk with a moderate intensity. Patients will also perform 5 minutes of warm-up and stretching."
16003294|NCT02864576|Behavioral|Cognitive Remediation_Health Promotion|"Cognitive Remediation:
~The REHACOP program consists of: Attention unit training sustained, selective, alternant and divided attention; Memory unit focusing on visual and verbal learning, recall and recognizing memory; Language unit including grammar, syntax, vocabulary, verbal fluency, verbal comprehension, abstract language; Executive functions unit training cognitive planning, proverbs, analogies; and Social cognition unit exercising theory of mind, social reasoning and moral dilemmas.
~Health Promotion:
~12 weeks of health promotion sessions. These sessions will be carried out by a specialized/trained nurse."
16003295|NCT02864563|Procedure|Blood sampling|"Blood sample at diagnosis to evaluate MYCN amplification in plasma.
~In case of NB with a MYCN amplification, blood samples are also collected during treatment and follow-up."
16003296|NCT02864550|Drug|Doxycycline|doxycycline 100mg orally daily
16003297|NCT02864550|Other|Placebo|placebo capsule identical in appearance, taste, and size to the capsule provided to the intervention group
16003298|NCT02864537|Other|Training|Patients were trained to measure INR and dose warfarin
16003299|NCT02864524|Other|Manipulative and Massage Therapy|
16003300|NCT02864524|Other|Exercise Program|
16003303|NCT02864498|Drug|Placebo|
16003304|NCT02864485|Procedure|live donor liver transplantation|live donor liver transplantation
16003305|NCT02864472|Procedure|PDT|PDT and ranibizumab
16003306|NCT02864472|Drug|Ranibizumab|Ranibizumab
16003307|NCT02864472|Drug|ranibizumab PRN|ranibizumab PRN
16003308|NCT02864459|Other|Muscular ultrasound|Muscular ultrasound is done before extubation
16003309|NCT02864420|Other|Home hospitalization|
16003310|NCT02864420|Other|Inpatient Hospitalization|
16003311|NCT02864407|Drug|Vahelva Respimat(Tiotropium + Olodaterol)|2.5 microgram and 2.5 microgram 2 puffs comprise one medicinal dose
16003312|NCT02864394|Biological|Pembrolizumab|Pembrolizumab administered IV at 2 mg/kg on Day 1 of each 21-day cycle for up to 35 doses (approximately 24 months).
16003313|NCT02864394|Drug|Docetaxel|Docetaxel administered IV at 75 mg/m^2 on Day 1 of each 21-day cycle as per the approved product label.
16003314|NCT02864381|Drug|Andecaliximab|800 mg administered via IV infusion
16003315|NCT02864381|Drug|Nivolumab|3 mg/kg administered via IV infusion
16003316|NCT02864368|Drug|5-day TMZ|Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of 150-200 mg/m^2/day on days 1-5 of each 28 day cycle
16003317|NCT02864368|Drug|21-day TMZ|Chemotherapy agent FDA approved to treat newly-diagnosed glioblastoma given as cycles of dose-intensified TMZ (75-100 mg/m2/day on days 1-21 of each 28 day cycle)
16003318|NCT02864368|Biological|PEP-CMV|500 µg of PEP-CMV Component A (a synthetic long peptide) mixed with Montanide ISA-51 intradermally administered in the right groin and, 2 hours later, 500 µg of PEP-CMV Component B (a neutralizing antibody epitope from human CMV glycoprotein B conjugated to Keyhole Limpet Hemocyanin) mixed in 150 µg of GM-CSF intradermally administered in the left groin
16003319|NCT02864368|Drug|Tetanus-Diphtheria booster|At time of enrollment, after signing consent and undergoing immune monitoring blood work, patients will receive Tetanus-diphtheria booster vaccination with 0.5 mL of Td (tetanus, diphtheria toxoid, absorbed)
16003320|NCT02864368|Drug|Tetanus Pre-Conditioning|All patients will receive a tetanus pre-conditioning injection in the right groin intradermally on day 22 (±1 day) of the first post-radiation cycle of TMZ
16003321|NCT02864355|Device|Goal Directed Therapy|Participants in this group will have a FloTrac monitor attached to their arterial line and the Goal Directed Therapy algorithm will be followed to manage blood pressures.
16003322|NCT02864342|Device|Arm 1: BreatheMate device with application|The service known as 'BreatheMate' is a patient support tool that monitors daily Symbicort inhaler use. The BreatheMate service includes a bluetooth monitoring device that is attached to subjects' Symbicort pMDI inhaler which automatically detects and logs their maintenance medication use. Subjects will receive audio-visual daily reminders (beeps and flashes) on the BreatheMate Bluetooth device. The bluetooth device transmits this data to a cellular phone that is provided to all subjects in the study. Subjects in the intervention group will also receive audio-visual alerts (beeps, flashes) from the bluetooth device to take their medication.
16003323|NCT02864342|Device|Arm 2: BreatheMate device without application|"The service known as 'BreatheMate' is a patient support tool that monitors daily Symbicort inhaler use. The BreatheMate service includes a bluetooth monitoring device that is attached to subjects' Symbicort pMDI inhaler which automatically detects and logs their maintenance medication use. The functionality of audio-visual daily reminders (beeps and flashes) is deactivated for this control group.
~The BreatheMate service also includes a cellular phone that will display whether the Bluetooth monitoring device is paired and communicating with the cellular phone. The Bluetooth device will transmit data regarding medication usage to the cellular phone."
16003324|NCT02864316|Drug|Nivolumab|
16003325|NCT02864303|Other|Saliva samples|saliva specimens were collected using a neutral or citric acid impregnated Salivette cotton swabs on Alzheimer patients to quantify the level of amyloid peptides
16003327|NCT02864277|Procedure|No Intervention Conventional Strategy|"The Conventional Strategy Group description encompasses over 4 pages of concise directions on how to take care of the participant. This cannot be reduced to less than 1000 characters.
~Preoperative Management Interoperative Management Postoperative Management Post discharge"
16003328|NCT02864277|Procedure|ERAS|"The ERAS Group description encompasses over 3 pages of concise directions on how to take care of the participant. This cannot be reduced to less than 1000 characters.
~Preoperative Management Interoperative Management Postoperative Management Post discharge"
16003329|NCT02864264|Drug|BMS-986184|
16003330|NCT02864264|Drug|Placebo matching BMS-986184|
16003331|NCT02864251|Biological|Nivolumab|Specified dose on specified days
16003332|NCT02864251|Biological|Ipilimumab|Specified dose on specified days
16003333|NCT02864251|Drug|Pemetrexed|Specified dose on specified days
16003334|NCT02864251|Drug|Cisplatin|Specified dose on specified days
16003335|NCT02864251|Drug|Carboplatin|Specified dose on specified days
16003336|NCT02864238|Other|electronic milestone pathway|an electronic based, clinical milestone driven pathway developed to guide the care of cardiac valve surgery patients.
16003337|NCT02864225|Device|Scalp electrode,|the parturient will be connected to the routine fetal Doppler and to the EUM. and When necessary to the scalp electrode will be connected. Tracings will be recorded simultaneously from all three devices until delivery. three separate outputs will be processed Output of the scalp electrode recording. Output of the fetal doppler. Output of the EUM. Three noncontinuous segments of 30 minutes each with two segments occurring during the first stage of labor and the third occurring during the second stage of labor, will be randomly picked from the scalp electrode recording with 3 matching segments in time from the EUM100pro and the fetal doppler
16003338|NCT02864225|Device|Fetal doppler|the parturient will be connected to the routine fetal Doppler and to the EUM. and When necessary to the scalp electrode will be connected. Tracings will be recorded simultaneously from all three devices until delivery. three separate outputs will be processed Output of the scalp electrode recording. Output of the fetal doppler. Output of the EUM. Three noncontinuous segments of 30 minutes each with two segments occurring during the first stage of labor and the third occurring during the second stage of labor, will be randomly picked from the scalp electrode recording with 3 matching segments in time from the EUM100pro and the fetal doppler
16003374|NCT02863939|Other|exercise|
16003530|NCT02862535|Drug|Andecaliximab|Administered via intravenous (IV) infusion (approximately 30 minutes)
16003531|NCT02862535|Drug|S-1|Administered orally
16003339|NCT02864225|Device|EUM|the parturient will be connected to the routine fetal Doppler and to the EUM. and When necessary to the scalp electrode will be connected. Tracings will be recorded simultaneously from all three devices until delivery. three separate outputs will be processed Output of the scalp electrode recording. Output of the fetal doppler. Output of the EUM. Three noncontinuous segments of 30 minutes each with two segments occurring during the first stage of labor and the third occurring during the second stage of labor, will be randomly picked from the scalp electrode recording with 3 matching segments in time from the EUM100pro and the fetal doppler
16003340|NCT02864199|Drug|Peginterferon alfa-2a|Peginterferon alfa-2a will be administered for 12 to 48 weeks. The dose will range from 135 mcg (Group C) to 180 mcg (Groups A, B, and D) once weekly via SC route.
16003341|NCT02864199|Drug|Ribavirin|Ribavirin will be administered for 12 to 48 weeks. The total daily dosage will range from 200 mg (Group C) to 1200 mg (Group D), depending upon CrCl and participant-specific factors.
16003342|NCT02864186|Device|control|Women wont use support bra 24 hours a days for six months
16003343|NCT02864186|Device|surgical support bra|Women will use surgical support bra 24 hours a day for six months
16003344|NCT02864186|Device|common support bra|Women will use common support bra 24 hours a day for six months
16003345|NCT02864173|Genetic|Whole genome small nucleotide polymorphism genotyping|
16003346|NCT02864160|Behavioral|Health Coaching|Life style coaching in 3 in-person meetings and 14 phone calls; written educational materials; self-management tools (stretch band, a glucometer, and a diabetes cookbook in Spanish).
16003347|NCT02864160|Behavioral|Comparison Group|Written educational materials; self-management tools (stretch band, a glucometer, and a diabetes cookbook in Spanish).
16003348|NCT02864147|Drug|9-valent HPV vaccine|All women (regardless of age) will be administered a dose of the HPV vaccine on day of enrollment (regardless of previous HPV vaccination history). Women previously unvaccinated will receive an additional booster dose at 8 weeks.
16003349|NCT02864147|Drug|Imiquimod|At the baseline visit, this group will be instructed about the correct method of self-application of imiquimod 6.25mg as a vaginal suppository and receive a 16 week course of the drug.
16003350|NCT02864121|Other|all patients included in IDAHO study|
16003351|NCT02864095|Drug|Tranexamic acid (TXA)|IV and topical administration
16003352|NCT02864095|Drug|Epinephrine|
16003353|NCT02864082|Drug|PAT-001, 0.1%|PAT-001 is a topical ointment. PAT-001, 0.1% contains 0.1% of active drug.
16003354|NCT02864082|Drug|PAT-001, 0.2%|PAT-001 is a topical ointment. PAT-001, 0.2% contains 0.2% of active drug.
16003355|NCT02864082|Drug|Vehicle for PAT-001 0.1%|Vehicle topical ointment contains 0.0% of active drug and is color matched to the active test article, PAT-001 0.1%.
16003356|NCT02864082|Drug|Vehicle for PAT-001 0.2%|Vehicle topical ointment contains 0.0% of active drug and is color matched to the active test article, PAT-001 0.2%.
16003357|NCT02864069|Behavioral|Walking Intervention|The walking intervention will begin following baseline assessments and will be continued for 12 weeks. Participants will be given a pedometer to use daily and log their daily steps, with an identified goal of increasing step counts by 3000 steps a day over the course of the intervention. After obtaining a week long baseline step count, individuals in the intervention group will progressively increase their step counts by 100 steps daily each week for the first three weeks, by 200 steps daily for weeks four through six, by 300 steps daily for weeks seven through nine, and by 400 steps daily for weeks ten through twelve. Mean baseline step counts for sedentary older adults in our pilot work were 4150 per day; therefore, most participants will almost double their daily activity by the end of the intervention.
16003358|NCT02864069|Behavioral|Cognitive Training Intervention|In the CT condition, participants will use Brain HQ, a computer cognitive training program (Posit Science Corporation, San Francisco, CA), shown to be well tolerated by older adults with positive short- and long-term cognitive outcomes. Participants will use the program 60 minutes/day, 5 days/week for 12 weeks. If participants do not have a home computer/internet access, they can complete the modules at another location such as a public library, senior center, or at the MARC, but training will still be self-directed.
16003359|NCT02864069|Behavioral|Combined Intervention|The combined condition will concurrently follow both the walking and the CT programs as described above.
16003360|NCT02864056|Other|Tai Chi|Ancient Chinese form of mind/body gentle exercise; this will be done while standing to improve postural balance.
16003361|NCT02864043|Device|NvisionVLE with Real Time Targeting|Physician will complete a VLE scan of the esophagus and target areas of interest using the VLE optical marking probe
16003362|NCT02864043|Procedure|esophagogastroduodenoscopy (EGD)|Standard of care EGD
16003363|NCT02864030|Drug|ERIBULIN MESYLATE|"Eribulin mesylate will be administered according to the European Medicines Agency (EMA) and Italian Medicines Agency (AIFA) approved indications and schedule consists in 1.23 mg/m2 on day 1 and on day 8 of each cycle. Cycles will be repeated every 21 days until progression of disease, unacceptable toxicity, patient refusal or medical decision.
~The decision to treat patients with Eribulin is independent from the trial. Patients will be treated and managed according to clinical practice. The physician can choose any further line of treatment after disease progression with Eribulin."
16003364|NCT02864017|Procedure|Enteral nutrition|
16003365|NCT02864017|Dietary Supplement|L-Citrulline|
16003366|NCT02864017|Dietary Supplement|Placebo|
16003369|NCT02863991|Drug|ONC201|ONC201
16003370|NCT02863978|Other|Multimodal signal acquisitions|"Cardiac and respiratory signals are collected from the clinical monitoring routinely gathered in hospital neonatal units.
~Movement quantification and baby's sounds are extracted thanks to a dedicated system which will collect images and sound with microphones and cameras."
16003371|NCT02863952|Other|Single photon emission computed tomography myocardial perfusion imaging|
16003372|NCT02863952|Device|novel cadmium-zinc-telluride (CZT) SPECT cameras|
16003373|NCT02863939|Device|Single photon emission computed tomography myocardial perfusion imaging|a novel cadmium-zinc-telluride (CZT) SPECT camera
16003375|NCT02863926|Biological|Injection of cBMA aspirate into the index leg|Injection of cBMA into the anterior tibialis muscle and upper index leg of subjects scheduled for semi-elective BKA 7-21 days before surgery
16003376|NCT02863913|Biological|PD-1 Knockout T Cells|PD-1 Knockout T Cells and PD-1 wild-type T Cells will be made by Cell Biotech Co., Ltd. 2x107/kg T cells will be used for test group and comparable group separately.
16003377|NCT02863913|Drug|Cyclophosphamide|"Cyclophosphamide at 20mg/kg single dose will be administered 3 days i.v. before cell infusion.
~Interleukin-2 (IL-2) will be given in the following 5 days, 720000 international unit（IU）/Kg/day (if tolerant)."
16003378|NCT02863913|Drug|IL-2|Interleukin-2 (IL-2) will be given in the following 5 days after cell infusion, 720000 international unit（IU）/Kg/day (if tolerant).
16003379|NCT02863900|Other|cohort of BC of each subtypes|
16003380|NCT02863887|Behavioral|Weight loss intervention|The intervention will involve utilizing trained community health coaches to deliver the weight loss intervention. There will be 10 group based sessions conducted at each church over 6 months. Session frequency will be 4 weekly sessions (4) for the first month, bimonthly sessions for 2 months (4) and monthly sessions for 2 months (2). The study is based upon weight loss strategies that have been utilized in the Diabetes Prevention Program. The group sessions will be augmented by utilizing text messages. The text messages will be delivered weekly and three types of messages will be delivered: 1) lesson content, 2) motivational, 3) behavioral prompts.
16003381|NCT02863874|Device|VicrylPlus®|Suture
16003382|NCT02863874|Device|Vicryl®|Suture
16003383|NCT02863861|Drug|Dexmedetomidine-ketamine|
16003384|NCT02863861|Drug|propofol-ketamine|
16003385|NCT02863848|Dietary Supplement|OraftiR inulin-type fructans|
16003386|NCT02863848|Dietary Supplement|Placebo|maltodextrin
16003387|NCT02863835|Other|EIT|All participants will have continuous monitoring of EIT whilst self venting
16003388|NCT02863835|Other|Salbutamol nebulisation and with CPAP|All participants will have continuous monitoring - salbutamol nebulisation will be given during 15 minutes using 5mg of salbutamol. Assessments on CPAP will be performed at 3 different level of pressure during this time.
16003389|NCT02863822|Behavioral|Low FODMAP Diet|Subjects in the experimental arm, will be educated in the low fermentable oligo-di-monosaccharides and polyols (FODMAP) diet.
16003390|NCT02863822|Behavioral|Choose My Plate Diet|Subjects in the active comparator arm will be educated in the ChooseMyPlate.gov Diet.
16003391|NCT02863809|Drug|Riboflavin|Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods.
16003392|NCT02863809|Drug|Dextran|Dextran is used to increase the viscosity of the solution.
16003393|NCT02863809|Device|UVA Light Source|Avedro's KXL® System is a UVA irradiation system that uses a light emitting diode (LED) to deliver a dose of UVA light to a targeted treatment area for illuminating the cornea during corneal collagen cross-linking.
16003394|NCT02863783|Device|EUS with Fiducial|EUS will be used to place fiducial into pancreas tumor at time of biopsy
16003395|NCT02863770|Other|EUS enhanced with contrast to evaluate pancreas|Patients will receive intravenous contrast during EUS to assess whether it increases diagnostic yield of the examination
16003396|NCT02863744|Procedure|coronally advanced flap with subepithelial connective tissue graft|"Under local anesthesia 2% lignocaine hydrochloride using a No. 15 BP (Bard Parker) blade full thickness flap will be elevated till the MGJ (mucogingival junction) using a small periosteal elevator and a partial-thickness flap will be raised beyond the mucogingival junction to allow a passive coronal displacement of the flap completely covering the CEJ without tension.
~The donor site consisting of 2 mm thick palatal connective tissue graft will be harvested from the premolar to the first molar area using the 'trap door' technique.14 The connective tissue graft will be secured in position with 4-0 absorbable sutures in recipient sites.
~The flaps will be stabilized with sling suture in a coronal position, followed by interrupted suture on releasing incisions in an apico-coronal direction using 4-0 absorbable sutures."
16003397|NCT02863731|Other|Alternating working postures, first day|On the first day of measurement participants execute five test battery trials in alternating postures (sit/stand/sit/stand/sit). On the second day of measurement participants execute the test battery in a sitting posture (sit/sit/sit/sit/sit).
16003398|NCT02863731|Other|Alternating working postures, second day|On the first day of measurement participants execute five test battery trials in a sitting posture (sit/sit/sit/sit/sit). On the second day of measurement participants execute the test battery in alternating postures (sit/stand/sit/stand/sit).
16003399|NCT02863718|Drug|Ibrutinib|Bruton's tyrosine kinase Inhibitor Ibrutinib 420mg daily
16003400|NCT02863718|Drug|Placebo|Placebo 420mg daily
16003401|NCT02863705|Drug|brimonidine tartrate/timolol malate Ophthalmic Solution|One drop of brimonidine tartrate/timolol malate (COMBIGAN®) Ophthalmic Solution in the affected eye, administered twice daily for 12 months
16003402|NCT02863705|Drug|bimatoprost ophthalmic solution 0.01%|Bimatoprost ophthalmic solution 0.01% (LUMIGAN®) administered once daily in the evening 5 minutes after COMBIGAN® instillation if additional lowering IOP is needed
16003403|NCT02863679|Drug|Tetracaine hydrochloride gel|Tetracaine hydrochloride gel contains 1% tetracaine hydrochloride, and a fair dose of fungicide, lubricants, remove foam agent, as the long-term local anesthetics.
16003404|NCT02863653|Other|observational study|application of several standard instruments in patients with rheumatoid arthritis
16003405|NCT02863640|Device|Color retinography|
16003406|NCT02863640|Device|Optical coherence tomography|
16003407|NCT02863640|Device|Fundus autofluorescence imaging|
16003408|NCT02863627|Other|Newborn Care Pathway|consultation with the pediatric emergency, two telephone interviews to complete Questionnaires with the parents after the emergency department visit
16003409|NCT02863614|Drug|Ibuprofen 600 mg|
16003410|NCT02863614|Drug|Lorazepam 1 mg|
16003411|NCT02863614|Drug|Placebo|
16003412|NCT02863588|Biological|seropositive for Toxoplasma gondii|blood sample
16003413|NCT02863575|Drug|Ibuprofen/Caffeine|Ibuprofen/Caffeine fixed-dose combination
16003414|NCT02863575|Drug|Ibuprofen|Ibuprofen capsule
16003415|NCT02863575|Drug|Placebo|Placebo treatment
16003452|NCT02863172|Procedure|Blood Draw/Saliva Sample|About 2-3 tablespoons blood drawn. Participants may give a saliva sample instead.
16003453|NCT02863159|Device|Tecnis Multifocal 1-Piece IOL|+2.75D (ZKB00), +3.25D (ZKB00), +4.00D (ZMB00)
16003416|NCT02863562|Other|Kinesio taping|Kinesio taping technique was used on both ankles on the first day of training with the aim of functional and mechanical correction, following the method described by Duenas et al. It was removed on the second day of training. This procedure was repeated each week for one month.
16003417|NCT02863562|Other|Proprioceptive exercises|Proprioceptive exercises were performed twice a week for one month. They were incorporated into their normal training routine (twice per week), and included 20 min of standardised proprioceptive exercises: single leg balancing on stable surfaces, on bosu/togu balls, and hopping activities, all repeated with eyes open/closed.
16003418|NCT02863562|Other|Placebo Kinesio taping|
16003419|NCT02863549|Device|MitraClip in tricuspid valve|MitraClip in tricuspid valve
16003420|NCT02863536|Device|Polybactum®|3 cycles treatment one per month.. Duration of one cycle: 1 week; administration for each cycle: 1 ovule at Day 1, 1 ovule at Day 4; 1 ovule at Day 7.In the two following cycles, the same treatment will be repeated immediately after the end of the first and second menstrual bleeding.
16003421|NCT02863523|Behavioral|Integrated Behavioral Care|Patients receive intensive behavioral counseling that may include elements of cognitive behavioral therapy, problem solving therapy, and small changes lifestyle counseling in addition to medical care.
16003422|NCT02863510|Device|Renal Sympathetic Denervation|Renal sympathetic denervation is a minimally invasive, endovascular catheter-based procedure using radiofrequency ablation of sympathetic nerves located in the walls of renal arteries, aimed at treating treatment-resistant hypertension.
16003423|NCT02863497|Behavioral|Mindfulness-based Sex Therapy|These group sessions will include education about sexuality, and the practice of mindfulness skills (including paying attention to the present moment, and to body sensations). Each group will include 7-8 women, plus the group facilitators. The group facilitators for the study will include Dr. Laurel Paterson (who has extensive experience in administering Mindfulness-based sex therapy in other populations of women), and occasionally one of the research team members.
16003424|NCT02863484|Other|surgery|pealing of the outer layer of the cavernous sinus
16003425|NCT02863471|Drug|Gemcitabine|1000 milligram (mg)/square meters (m2) body surface 60 minutes (min) intraperitoneal hyperthermic lavage
16003426|NCT02863445|Drug|Levonorgestrel-based emergency contraception 1.5 mg|Evaluating pharmacodynamic outcomes in obese women using 1.5mg versus 3.0mg of LNG-based EC
16003427|NCT02863445|Drug|Levonorgestrel-based emergency contraception 3.0mg|Evaluating pharmacodynamic outcomes in obese women using 1.5mg versus 3.0mg of LNG-based EC
16003428|NCT02863419|Drug|semaglutide|Oral semaglutide once-daily.
16003429|NCT02863419|Drug|liraglutide|Subcutaneous (s.c.) injection once-daily.
16003430|NCT02863419|Drug|placebo|Placebo once-daily.
16003431|NCT02863406|Other|Bronchoalveolar lavage|Bronchoalveolar lavage in order to determine rate of dust
16003432|NCT02863393|Other|Diaphragmatic breathing exercise|Through diaphragmatic breathing exercise to verify the impact of this item interventions on patients' metabolism indicators.
16003433|NCT02863380|Procedure|Functional magnetic resonance imaging used to individualize rTMS protocol|Procedure consisting in personalizing the rTMS targets and stimulation pattern based on functional magnetic resonance imaging
16003434|NCT02863380|Device|Individualized rTMS (transcranial magnetic stimulation)|
16003435|NCT02863380|Device|Classical rTMS (transcranial magnetic stimulation)|
16003436|NCT02863380|Device|Classical tDCS (transcranial direct current stimulation)|
16003437|NCT02863367|Drug|Apatinib|Apatinib：500 mg，po，qd, d1-14, every 3 week
16003438|NCT02863367|Drug|Gemcitabine|Gemcitabine：1000mg/m²，vein input 30-40，d1，d8，every 3 week
16003439|NCT02863354|Drug|Aflibercept|Intravitreal injection
16003440|NCT02863341|Other|Team-care deprescribing with deprescribing guide|Beers criteria 2015, STOPP criteria 2014, drug interaction
16003441|NCT02863328|Drug|semaglutide|Oral administration once-daily.
16003442|NCT02863328|Drug|empagliflozin|Oral administration once-daily.
16003443|NCT02863315|Device|tsDCS|"Both groups use the same DC-Stimulator Plus (NeuroConn GmbH, Ilmenaus, Germany).
~In the tsDCS group, anode electrode is placed over tenth thoracic vertebra to target spinal cord with 2mA for 20 min, and the cathode (reference) electrode on the head vertex (in the Cz location according to the 10-20 EEG system)
~In sham tsDCS group, anode electrode is placed over tenth thoracic vertebra to target spinal cord with 2mA for 30s, and the cathode (reference) electrode on the head vertex (in the Cz location according to the 10-20 EEG system). The current was discontinued after 30 s while the power indicator remained on."
16003444|NCT02863302|Other|Reflexology treatment|All patients will receive reflexology (a specialized foot therapy) from a certified reflexologist twice weekly from the beginning of chemotherapy treatment.
16003445|NCT02863276|Procedure|Intensified insulin therapy|
16003446|NCT02863263|Device|Foam Dressing|The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device on its own. Subjects are randomised to one of 2 arms.
16003447|NCT02863263|Device|Foam Dressing with Povidone Iodine|The purpose of the study is not to compare between the 2 devices, but to determine the efficacy of each type of device own. Subjects are randomised to one of 2 arms.
16003448|NCT02863198|Device|endometrial injury|Endometrial injury was done only for patient of the study group. It was done on day 5, under complete aseptic conditions, no anesthesia, was given in most of cases. Endometrial local injury was performed on the posterior wall, midline, and 10-15 mm from the fundus using pipelle endometrial sampling (Pipelle).
16003449|NCT02863185|Drug|Pitavastatin|
16003450|NCT02863185|Drug|Atorvastatin|
16003451|NCT02863172|Behavioral|Questionnaires|"Consenting Proband Group: Participants fill out questionnaires about work, family history, medical history, and health habits at baseline. It should take about 20 minutes to complete the questionnaires. Participants also complete a health and lifestyle questionnaire, which contains 20 questions for men and 22 questions for women. Questionnaire should take about 10 minutes to complete. Follow-up questionnaire at least 1 time in 5 years to update medical, cancer, and family history.
~Family Members (MDA Registered Patients) Group and Family Members (Not MDA Registered Patients) Group: Participants complete a health questionnaire, which collects information about their personal medical history, demographics (age, race, sex, and so on), and questions about their alcohol and tobacco use at baseline. Questionnaire should take about 20 minutes to complete. Participants complete follow-up questionnaire at least 1 time in 5 years to update their medical, cancer, and family history."
16003454|NCT02863133|Device|Liquid Embolic|The Easyx liquid embolic, manufactured by Antia AG, is intended to occlude hypervascular lesions in the brain such as tumors, arteriovenous malformations (a tangle of abnormal and poorly formed blood vessels) and dural arteriovenous fistulas (abnormal connection of blood vessels).
16003455|NCT02863120|Drug|liposomal bupivacaine|
16003456|NCT02863120|Drug|bupivacaine HCl|
16003457|NCT02863120|Drug|Ropivacaine|
16003458|NCT02863120|Drug|Saline|
16003459|NCT02863107|Procedure|Biospecimen Collection|Undergo collection of blood or saliva samples
16003460|NCT02863107|Other|Medical Chart Review|Review of medical charts
16003461|NCT02863107|Other|Quality-of-Life Assessment|Ancillary studies
16003462|NCT02863107|Other|Questionnaire Administration|Complete questionnaires
16003463|NCT02863094|Device|transcranial magnetic stimulation|
16003464|NCT02863081|Other|Survey|Administered to healthcare providers
16003465|NCT02863081|Other|interview|Administered to patients and LAR (i.e., interviews)
16003466|NCT02863068|Drug|Topical Sodium Nitrite|"Subjects will have 0.1 cm of 2% sodium nitrite cream applied per 1 cm2 of the total ulcerated area. Areas will be rounded to the nearest 1 cm2. If a subject has more than one ulcer, all of them will be treated with either study cream in this intervention."
16003467|NCT02863068|Other|Placebo|Subjects will have Placebo applied to total ulcerated area. If a subject has more than one ulcer, all of them will be treated with placebo in this intervention.
16003468|NCT02863055|Drug|Nintedanib|Nintedanib 200 mg administered twice daily
16003469|NCT02863055|Drug|Placebo|Matching placebo administered twice daily
16003470|NCT02863042|Procedure|Repair Deltoid Tendon|
16003471|NCT02863042|Other|Ankle Fracture Without Deltoid Tendon Repair|Standard of care
16003472|NCT02863029|Procedure|Flexible Sigmoidoscopy|A sigmoidoscopy is the minimally invasive medical examination of the large intestine from the rectum through the last part of the colon, using a flexible endoscope.
16003473|NCT02863016|Device|SelectBag One|Each patient will be subjected to two stages of each month, where it will be treated with online HDF postdilution with two kind of concentrates: acetic acid (Ac-HDF) and acetate-free citrate containing one (HDF-Cit ). For each of the sessions will be used online HDF postdilution with TMP biofeedback (UltraControl) and Filter high permeability.
16003474|NCT02862977|Drug|ketoprofen and cyclobenzaprine association with caffeine|The patient will take 2 tablets (combination of ketoprofen and cyclobenzaprine and caffeine), oral, per day, each 12h
16003475|NCT02862977|Drug|Cyclobenzaprine with caffeine|The patient will take 2 tablets (combination of cyclobenzaprine and caffeine), oral, per day, each 12h
16003476|NCT02862964|Other|identify L4/L5|"For each participant, a provider will first attempt to identify the L4/L5 space using the traditional technique of palpating the iliac crests to estimate spinal level. The provider will mark this space on the person's back with a single dot from a marking pen. The provider will then use the Accuro to again attempt to identify the L4/L5 interspace and mark this point with two dots.
~The participant will then be taken into the fluoroscopy suite for their scheduled procedure a metal instrument will be laid on the skin at the interspace or interspaces that were marked using the palpation and Accuro techniques. Metal instruments show up on fluoroscopy, but the skin markers will not.
~The anesthesiology attending in the fluoroscopy suite will then confirm the true interspace position of these marks under fluoroscopy performed for the standard of care procedure"
16003477|NCT02862938|Drug|NT-501 ECT implant|NT-501 ECT implant will be placed into the vitreous and out of the visual axis of the study eye. The surgical procedure involves making a small incision through the sclera (white part of the eye), inserting the implant and securing it with a suture.
16003478|NCT02862938|Other|Sham|Sham surgery
16003479|NCT02862925|Procedure|Fetal Scalp Stimulation|"During a routine vaginal exam, if there is concern for fetal distress based on local definitions, the midwife will gently stroke the fetal head with her finger. She will then observe for a rise in the fetal heart rate as observed by the Doppler monitor. A rise to above 15 beats per minute above the baseline is termed an acceleration and NEGATIVE test. Absence of an acceleration is a POSITIVE test and reason for intervention."
16003480|NCT02862912|Drug|Chloroprocaine|Administered as a single injection or continuously through an indwelling catheter - 50 mg
16003481|NCT02862912|Drug|Bupivacaine|A dextrose Solution is usually given as an injection - 9 mg (1.4 ml)
16003482|NCT02862912|Drug|Fentanyl|15 mcg Fentanyl will be included int he spinal anesthetic in both groups
16003483|NCT02862912|Drug|Saline|Preservative free normal saline (0.3 ml) to bring the volume to ~ 2 ml
16003484|NCT02862899|Device|Thermowire|
16003485|NCT02862886|Other|myometrium biopsy|
16003486|NCT02862873|Procedure|Spinal anaesthesia|
16003487|NCT02862873|Drug|Ondansetron|
16003488|NCT02862873|Other|saline solution|
16003489|NCT02862860|Biological|blood sample|
16003490|NCT02862860|Biological|urine sample|
16003491|NCT02862860|Device|installation of Holter|
16003492|NCT02862847|Other|stool samples|
16003493|NCT02862834|Genetic|High-throughput exome sequencing|
16003494|NCT02862821|Other|HR-EEG|
16003495|NCT02862795|Procedure|HPV detection in anal canal samples|Additional anal taking during the colonoscopy with cytobrush
16003496|NCT02862782|Drug|hCG (Ovitrelle 250 mcg mcg - Merck Serono)|
16003497|NCT02862782|Drug|hCG (Ovitrelle 250 mcg mcg - Merck Serono) + GnRH agonist (Decapeptyl 0.2mg - Ferring Gmgh)|
16003498|NCT02862769|Drug|Lidocaine|. Perioperatively, when lidocaine is administered as a continuous infusion at clinically relevant doses (1-2 mg/kg/hr) results in plasma concentration below 5µg.mL-1. At this plasma level, it is adequate to attenuate sympathetic responses , decrease pain and demonstrate a significant opioid sparing effect.
16003499|NCT02862769|Drug|Saline|The second group will include those who receive a intraoperative placebo infusion(saline infusion) (Induction bolus dose of 1.5 mg/kg body weight followed by a continous saline infusion 1.5 mg/kg/hr.
16003500|NCT02862756|Other|diffusion-weighted MRI and clinical examination|
16003501|NCT02862743|Other|patients with metastatic melanoma|Blood sample to realize molecular characterization of melanoma
16003529|NCT02862548|Drug|Other approved antivirals|Other approved antivirals (such as lamivudine, entecavir, or immunoglobulin antihepatitis B) administered per local practice
16071134|NCT02374567|Drug|Zaleplon|
16003502|NCT02862730|Device|Artificial Pancreas Controller in Dual Hormone Mode|The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon.
16003503|NCT02862730|Device|Subject's insulin pump|Subject will continue on their subcutaneous delivery of insulin on his/her own insulin pump using their own basal rates and carb ratios for meal boluses, managing their blood sugar as they normally would.
16003504|NCT02862730|Device|Artificial Pancreas Controller in Single Hormone Mode|The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
16003505|NCT02862730|Device|Artificial Pancreas Controller in Predictive Low Glucose Suspend Mode|The artificial pancreas controller contains an algorithm for managing blood glucose in people with type 1 diabetes which includes an exercise detection component. The new algorithm will have 3 modes: a single hormone closed-loop insulin only mode, a dual-hormone closed-loop insulin and glucagon mode and an insulin only mode with predictive low glucose suspend. Closed-loop Artificial Pancreas Controller includes insulin delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to one Tandem t:slim insulin pumps filled with insulin.
16003506|NCT02862704|Biological|MG7-CART|Ultrasound-guided intra-tumor injection as the route of T cell delivery, so that more T cells gathered at the tumor site, less migrate to the normal tissue, thereby enhancing the efficacy of anti-tumor, reducing the potential of side effects. And MG7-CART is a 2nd CAR, with MG7 as the target protein, 4-1BB as co- stimulator
16003507|NCT02862691|Drug|Acetaminophen/Oxycodone (Oral analgesic)|2 oral tablets of acetaminophen 325 mg plus oxycodone 5 mg given once
16003508|NCT02862691|Drug|Bupivicaine (Injectable local anesthetic)|local injection of bupivicaine 0.5% at root of maxillary tooth or nerve block for mandibular tooth
16003509|NCT02862678|Other|diffusion-weighted MRI|Two diffusion-weighted MRI will be performed (one 8 days before chemoradiotherapy treatment and one 3 months after the end of chemoradiotherapy treatment).
16003510|NCT02862665|Drug|iron isomaltoside 1000 (Monofer®)|The patients will receive iron isomaltoside 1000 (Monofer®) as an i.v. infusion of 1000 mg (diluted with normal saline, 10 mg/ml) twice; 3 days before surgery and 3 days after surgery. They will receive iron isomaltoside 1000 (Monofer®) 1000 mg over 15 min.
16003511|NCT02862665|Drug|normal saline 100 ml|The patients will receive normal saline 100 ml as an i.v. infusion twice; 3 days before surgery and 3 days after surgery. They will receive normal saline 100 ml over 15 min.
16003512|NCT02862652|Other|Blood sample|Blood sample to quantify microparticles and to study expression and activity of the tissue factor on their surface
16003513|NCT02862639|Device|Experimental group|patient receive intra articular injection (hip joint) of viscosupplementation in combination with corticosteroid
16003514|NCT02862639|Device|control group|patient receive intra articular injection (hip joint) of corticosteroid alone
16003515|NCT02862613|Procedure|TACE|Lipiodol 10-20ml,MMC 8～10mg,EADM20～40mg.According to tumor area of maximum diameter,0.1～0.2ml/cm2 Hepatic arterial infusion.
16003516|NCT02862613|Biological|Precision Cells|DC cell suspension (1×107 DC+ physiological saline + 0.25% human bloodalbumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. Precision cells suspension (1-6×109 Precision cells + physiological saline + 0.25% human bloodalbumin) 300ml for each infusion, IV (in the vein) for each infusion 3 cycles, each cycle received one infusions on day 21, 42, 63.
16003517|NCT02862600|Drug|Perhexiline|Period 1 (Weeks 1-8) and Period 2 (Weeks 9-16): dose titrated to two different plasma levels of perhexiline
16003518|NCT02862600|Device|Use of bioanalytical assay to monitor plasma levels of perhexiline|The bioanalytical assay is the device under investigation. It will be used to monitor plasma levels of perhexiline. The data obtained from this analysis will be used to guide dose adjustments of perhexiline.
16003519|NCT02862587|Drug|Chemotherapy|Cisplatin：60mg/m2，Gemcitabine：1g/m2,Physiological saline 100ml:IV (in the vein) once a week with a total of six times.
16003520|NCT02862587|Biological|precision cells|precision cells DC cell suspension (1×10*7 DC+physiological saline + 0.25% human bloodalbumin)1ml for each infusion, subcutaneous injection for each infusion, 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. PNAT/PMAT cell suspension (1-6×109 PNAT + physiological saline + 0.25% human bloodalbumin) 300ml for each infusion, IV (in the vein) for each infusion, 3 cycles, each cycle received one infusions on day 21, 42, 63.
16003521|NCT02862574|Drug|Andecaliximab|Administered via subcutaneous injection once weekly
16003522|NCT02862574|Drug|Placebo|Administered via subcutaneous injection once weekly
16003523|NCT02862574|Drug|Methotrexate|Administered orally weekly as part of the participant's current treatment regimen
16003524|NCT02862574|Drug|TNF Inhibitor|An approved stable subcutaneous formulation of one of the following TNF inhibitors may include adalimumab, certolizumab, etanercept, or golimumab.
16003525|NCT02862561|Drug|Chemotherapy|Cisplatin：60mg/m2，5-FU：500mg/m2,Physiological saline 100ml:IV (in the vein) once a week with a total of six times.
16003526|NCT02862561|Biological|Precision Cells|DC cell suspension (1×10*7 DC+physiological saline + 0.25% human bloodalbumin)1ml for each infusion, subcutaneous injection for each infusion, 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. Precision cells suspension (1-6×109 Precision cells + physiological saline + 0.25% human bloodalbumin) 300ml for each infusion, IV (in the vein) for each infusion, 3 cycles, each cycle received one infusions on day 21, 42, 63.
16003527|NCT02862548|Drug|TAF|25 mg tablet administered orally once daily
16003528|NCT02862548|Drug|TDF|Tablet administered orally once daily
16071135|NCT02374567|Drug|Melatonin|
16003532|NCT02862535|Drug|Cisplatin|Administered via IV infusion on Day 8 of every 5 weeks
16003533|NCT02862535|Drug|Oxaliplatin|Administered via IV infusion for over 2 hours on Day 1 of each 21-day cycle
16003534|NCT02862535|Drug|Nivolumab|Administered via IV infusion (approximately 60 minutes) every 2 weeks
16003535|NCT02862522|Other|Questionnaire of overall health|The standardized questionnaire was used to assess occurrence of major adverse cardiovascular events including stroke, re-hospitalization, myocardial infarction or death. Responses were verified by medical record review conducted by an investigator blinded to the results of the standardized questionnaire.
16003536|NCT02862509|Drug|Budesonide nasal instillation|
16003537|NCT02862509|Drug|Normal saline nasal instillation|
16003538|NCT02862483|Drug|Tamsulosin 0.2mg|
16003539|NCT02862483|Drug|Tadalafil 5mg|
16003540|NCT02862483|Drug|Placebo for Tamsulosin|
16003541|NCT02862457|Drug|Epacadostat 25 mg|"25 mg tablet administered orally, twice a day (BID) on Days 1-5 and Days 8-28 of Cycle 1 (28-day Cycle) and Days 1-21 of Cycles 2 through 35 (21-day Cycles) for the Epacadostat (Epacad) study arm and on Days 1-21 of Cycles 1 through 35 (21-day Cycles) for the Epacad+Pembrolizumab (Pembro) study arm."
16003542|NCT02862457|Drug|Epacadostat 100 mg|"100 mg tablet administered orally, twice a day (BID) on Days 1-5 and Days 8-28 of Cycle 1 (28-day Cycle) and Days 1-21 of Cycles 2 through 35 (21-day Cycles) for the Epacadostat (Epacad) study arm and on Days 1-21 of Cycles 1 through 35 (21-day Cycles) for the Epacad+Pembrolizumab (Pembro), Epacad+Pembro+Cisplatin+Pemetrexed, Epacad+Pembro+Carboplatin+Pemetrexed, Epacad+Pembro+Carboplatin+Paclitaxel study arms."
16003543|NCT02862457|Biological|pembrolizumab 200 mg|"Administered as an intravenous (IV) infusion on Day 8 of Cycle 1 (28 days) and Day 1 of Cycles 2 through 35 (21-day Cycles) for the Epacadostat (Epacad) study arm and on Day 1 of Cycles 1 through 35 (21-day Cycles) for the Epacad+Pembrolizumab (Pembro), Epacad+Pembro+Cisplatin+Pemetrexed, Epacad+Pembro+Carboplatin+Pemetrexed, Epacad+Pembro+Carboplatin+Paclitaxel study arms."
16003544|NCT02862457|Drug|Cisplatin 75 mg/m^2|Administered as an IV infusion on Day 1 of Cycles 1 through 4
16003545|NCT02862457|Drug|Carboplatin Area Under the Curve (AUC)5|Administered as an IV infusion on Day 1 of Cycles 1 through 4
16003546|NCT02862457|Drug|Pemetrexed 500 mg/m^2|Administered as an IV infusion on Day 1 of Cycles 1 through 4
16003547|NCT02862457|Drug|Paclitaxel 200 mg/m^2|Administered as an IV infusion on Day 1 of Cycles 1 through 4
16003548|NCT02862457|Drug|Carboplatin AUC6|Administered as an IV infusion on Day 1 of Cycles 1 through 4
16003549|NCT02862444|Other|Culturally Appropriate Intervention|Women in the intervention arm will receive a culturally appropriate intervention that will be provided to them according to the five strategies of culturally appropriate interventions of Kreuter et al. (2003).
16003550|NCT02862431|Drug|JNJ-64565111|Participants will receive JNJ-64565111 subcutaneously in the abdomen on Days 1, 8, 15 and 22.
16003551|NCT02862431|Drug|Placebo|Participants will receive Placebo subcutaneously in the abdomen on Days 1, 8, 15 and 22.
16003552|NCT02862418|Other|UTE MRI|One MRI with UTE settings will be acquired.
16003553|NCT02862405|Other|vision tests|
16003554|NCT02862379|Behavioral|home-based program|The objective of the rehabilitation program is to reduce the risk of falls after management of the risk factors identified. This intervention is a home-based program combining exercises, home modifications and education on fall risk factors
16003555|NCT02862366|Other|Blood sampling|Blood sampling every 6 month following the routine calendar of visit
16003556|NCT02862353|Biological|blood sample|15 ml of blood
16003557|NCT02862340|Genetic|Genetic test|
16003558|NCT02862327|Drug|intravenous dexamethasone|intravenous injection of dexamethasone
16003559|NCT02862327|Drug|intravenous placebo|intravenous injection of placebo
16003560|NCT02862327|Drug|perineural ropivacaine|brachial plexus block with perineural injection of Ropivacaine in the axillary fossa
16003561|NCT02862327|Other|ultrasound guidance|ultrasound guidance for brachial plexus block in the axillary fossa
16003562|NCT02862314|Biological|Blood sample|
16003563|NCT02862301|Biological|blood sample|
16003564|NCT02862288|Device|Microwave ablation with Acculis Accu2i pMTA Applicator|
16003565|NCT02862275|Drug|Atezolizumab|Given IV
16003566|NCT02862275|Other|Laboratory Biomarker Analysis|Correlative studies
16003567|NCT02862262|Device|ARIES Bordetella Assay|
16003568|NCT02862249|Biological|Faecal microbiota transplantation|The FMT (200mls) will be administered following preparation of the bowel with MoviPrep®, into the duodenum via a gastroscope derived from 50g of fresh donated stool from a healthy donor. The gastroscopy will be performed as per the King's College Hospital Gastroenterology Protocol.
16003569|NCT02862249|Biological|Placebo|An identical appearing placebo solution (200mls 0.9% normal saline and 12.5% glycerol) will be administered into the duodenum via a gastroscope in a single blinded fashion following preparation of the bowel with MoviPrep®.
16003570|NCT02862236|Drug|Hypericum perforatum extract|250 or 500 mg Remotiv capsules of hypericum perforatum extract, p.o.
16003571|NCT02862223|Dietary Supplement|Neoprinol|
16003572|NCT02862210|Drug|Lithium Carbonate|Lithium will be prescribed starting at 150 mg/day, with subsequent dose titration to 300, 450, and 600 mg/day as tolerated according to side effects and blood lithium level.
16003573|NCT02862210|Drug|Placebo|Placebo will be prescribed starting at 1 pill per day, with subsequent dose titration to 2,3, and 4 pills per day as tolerated by sham blood lithium levels.
16003574|NCT02862171|Drug|Dapivirine Vaginal Ring-004|To assess the safety profile of the 25 mg Dapivirine Vaginal Ring-004, when inserted at monthly intervals, in an open-label trial
16003575|NCT02862158|Device|FDT visual field|
16003576|NCT02862158|Device|Standard HVF|
16003577|NCT02862145|Drug|MRX34|Treatment of melanoma with pharmacodynamics biopsy of tissue and blood
16003578|NCT02862145|Drug|Dexamethasone|Premedication during the week of treatment
16003579|NCT02862132|Drug|Vedolizumab|
16003580|NCT02862119|Procedure|FFR Treatment Arm|Fractional Flow Reserve-guided PCI of non-culprit lesions during index hospital admission
16003581|NCT02862119|Other|Conservative Treatment Arm|Initial Conservative management of non-culprit lesions during index hospital admission
16003582|NCT02862106|Biological|εPA-44|subcutaneously injection of εPA-44 900μg at week 83,86,89,92,95,98,101,104,108,112,116,120,124,128
16003583|NCT02862093|Device|Repetitive Transcranial Magnetic Stimulation|Repetitive Transcranial Magnetic Stimulation of the dorsolateral prefrontal cortex
16003584|NCT02862080|Device|cathode tsDCS|Non-invasive electrical stimulation, transcutaneous spinal direct current stimulation (tsDCS) is the application of electrical current to the spinal cord via surface electrodes placed on the skin.
16003585|NCT02862080|Device|Ekso|Ekso is a type of wearable robotic exoskeleton that provides support to an individual with lower extremity paralysis for standing and walking.
16003586|NCT02862080|Device|anode tsDCS|Non-invasive electrical stimulation, transcutaneous spinal direct current stimulation (tsDCS) is the application of electrical current to the spinal cord via surface electrodes placed on the skin.
16003587|NCT02862067|Other|Assessment of cardiorespiratory fitness|Assessment of cardiorespiratory fitness
16003588|NCT02862054|Procedure|splenectomy|
16003589|NCT02862041|Device|Echogenic needle - Pajunk sonoplex echogenic needle|Ultrasound guided infraclavicular brachial plexus block for upper extremity surgeries
16003590|NCT02862041|Device|Non Echogenic needle - Stimuplex Braun Nonechogenic needle|Ultrasound guided infraclavicular brachial plexus block for upper extremity surgeries
16003591|NCT02862028|Biological|HerinCAR-PD1 cells|herinCAR-PD1 cells transfusion: (1-5×107/kg herinCAR-PD1 + physiological saline + 0.25% human alloalbumin) 300ml for each infusion. IV (in the vein) for each infusion, 2 cycles, each cycle received one infusions on day 21, 43.
16003592|NCT02862015|Other|Oncothermia|Oncothermia is a kind of hyperthermia treatment. It serves heat energy more selectively than conventional hyperthermia.
16003593|NCT02862015|Drug|FOLFIRINOX or Gemcitabine based chemotherapy|As a standard palliative chemotherapy, FOLFIRINOX or Gemcitabine based chemotherapy will be treated to the patients.
16003594|NCT02862002|Other|"therapeutic education of type caratif"|"study the effects of a therapeutic education program type caratif, based on a communication pedagogy, with the patient receiving opioid therapy in medical oncology"
16003595|NCT02862002|Other|Standard care|patients receiving standard care of cancer pain.
16003596|NCT02861989|Other|qualitative study|
16003597|NCT02861976|Other|Opioid risk screen development & implementation|Development of a screening tool for the risk of opioid misuse in patients with traumatic injury.
16003598|NCT02861963|Procedure|Experimental: RVOT reconstruction by femoral allogenic vein valve conduit|Right ventricular outflow tract reconstruction using femoral allogenic vein valve conduit under CPB and induced ventricular fibrillation
16003599|NCT02861963|Procedure|Systemic-to-pulmonary artery shunts|"Modified Blalock-Taussig shunt performed between the right subclavian and pulmonary arteries or the left subclavian and pulmonary arteries of the type end to side."
16003600|NCT02861950|Drug|Caudal block with ropivacaine|Patients in this arm will receive a caudal block with ropivacaine
16003601|NCT02861950|Drug|penile nerve block with bupivacaine|Patients in this arm will receive a penile block with bupivacaine
16003602|NCT02861937|Procedure|non surgical periodontal therapy|and root planing (SRP) was performed in two to four appointments lasting approximately 60 minutes each under local anaesthesia (2% lignocaine hydrochloride with 1:2,00,000 adrenaline) using area specific Gracey periodontal curettes and an ultrasonic device. The treatment was concluded in 3 weeks. Within the duration of the study, all subjects received supportive therapy, which included professional plaque control and reinstruction of oral hygiene.
16003603|NCT02861924|Other|microcirculatory responses|"The effect of the duration and intensity of the pressure; reproducibility and correlation with ischemic hyperemia post.
~measurements are made with the Imager SPECKLE imager (LSCI) give the microvascular perfusion data in arbitrary units called perfusion units (UP)."
16003604|NCT02861911|Other|Current flow between sensory and motor threshold|Artificial strength training by means of neuromuscular electrical stimulation (NMES)
16003605|NCT02861911|Device|Current intensity upper of motor threshold by Kneehab XP technology|Artificial strength training by means of neuromuscular electrical stimulation (NMES)
16003608|NCT02861885|Other|Chromoendoscopy|Colonoscopy will run in accordance with standard procedure, including air insufflation throughout the endoscope rise. The endoscope will be a Olympus NBI videoscope (180 series and latest). First, progression will run until caecum without systematic terminal ileum intubation. Polyps will be searched out during descent phase. The patient will be eligible as soon as the operator suspects an ascendant colon SSL with white light. The operator will have to initiate the WLI colonoscopy. If a SSL is suspected in the colon, the operator will run at the same time, a NBI colon examination, then an indigo carmine chromoendoscopy colon examination. Each lesion will be pictured before and after mucus clean-up. Lesions biopsy or resection will be ran in accordance with standard procedure.
16003609|NCT02861859|Drug|Olanzapine|Olanzapine 5 mg (2 x 2.5 mg) PO OD (once a day) on days 1-4.
16003610|NCT02861859|Drug|Olanzapine Placebo|Olanzapine Placebo 5 mg (2 x 2.5 mg) PO OD (once a day) on days 1-4.
16003611|NCT02861846|Biological|profile of CSF biomarkers of AD|dosage of biomarker of AD
16003612|NCT02861833|Other|nursing support|Determining the Variability of adaptation strategies and correlations with specific nursing management, individual and contextual characteristics of patients with cancerous wounds
16003613|NCT02861820|Device|MRI: Brain Imaging Data Collection|This study has no intervention, it is observational. The investigator will collect brain imaging data and behavioral assessments.
16003614|NCT02861807|Device|Brain stimulation with mindfulness-based relapse prevention|Participants will participate in weekly or twice weekly group mindfulness based relapse prevention (MBRP) + transcranial direct current stimulation (tDCS) intervention sessions for up to eight weeks. All participants will receive 8 two hour sessions of MBRP + tDCS, regardless of the group schedule. Subjects will receive 30 minutes of either active or sham tDCS stimulation, depending on their group assignment. After tDCS, sessions will include discussions of mindfulness as a means of coping with craving, cognitions, and emotions, role play exercises, and mindfulness practice.
16003615|NCT02861794|Procedure|GMK Sphere|Total Knee Replacement
16003616|NCT02861781|Other|Collection of blood samples and tissues|Collection of blood samples and tissues during bariatric surgery and blood samples during followup visits
16003617|NCT02861768|Biological|Pharyngeal swab|
16003713|NCT02861235|Other|Stress thallium-201 tomoscintigraphy, followed by a second rest tomoscintigraphy if necessary|with gamma-camera and D.SPECT camera
16003618|NCT02861755|Behavioral|Positive Affect Skills Training|Blend of enhancements may include: 5-minutes of facilitator contact, an online discussion board, or gamification via virtual flower badges.
16003619|NCT02861755|Behavioral|5-week Emotion Reporting|
16003620|NCT02861742|Other|Delivery of questionnaires|After patient and partner information, clinical research associate or clinical research nurse will give to the couple 2 booklets containing 5 questionnaires, respectively T1, T2, T3, T4 and T5.
16003621|NCT02861742|Behavioral|Questionnaire T1 to fill|T1 is to fill before chemotherapy.
16003622|NCT02861742|Behavioral|Questionnaire T2 to fill|T2 is to fill after the 6th cycle of chemotherapy.
16003623|NCT02861742|Behavioral|Questionnaire T3 to fill|T3 is to fill at the end of radiotherapy.
16003624|NCT02861742|Behavioral|Questionnaire T4 to fill|T4 is to fill 4 month after beginning of hormonotherapy or surveillance if no hormonotherapy.
16003625|NCT02861742|Behavioral|Questionnaire T5 to fill|T5 is to fill 1 year after the beginning of hormonotherapy or surveillance if no hormonotherapy.
16003626|NCT02861729|Other|Vita Suprinity|zirconia reinforced lithium silicate partial coverage restorations
16003627|NCT02861729|Other|IPS e.max|lithium disilicate partial coverage restorations
16003628|NCT02861716|Drug|Bupivacaine|"premedication with Ondansetron (Zofran®) 0.1 mg/kg and Diazepam ( 0.01 mg/kg ), then general anesthesia will be induced with inhalation of sevoflurane 8% in oxygen via face mask. After that intravenous cannula will be placed, and fluid therapy will be standardized during and after surgery.
~After securing the tube in place, the patients will be placed in the lateral decubitus position and a single dose of intrathecal anesthesia will be performed using a 25 gauge needle (Brown ®, Germany) and free flow of CSF technique. Then children will receive intrathecal bupivacaine (0.5%) 0.4mg/kg body weight in 2ml volume and it will be injected slowly over 20 seconds."
16003629|NCT02861716|Drug|Fentanyl|"premedication with Ondansetron (Zofran®) 0.1 mg/kg and Diazepam ( 0.01 mg/kg ), then general anesthesia will be induced with inhalation of sevoflurane 8% in oxygen via face mask. After that intravenous cannula will be placed, and fluid therapy will be standardized during and after surgery.
~After securing the tube in place, the patients will be placed in the lateral decubitus position and a single dose of intrathecal anesthesia will be performed using a 25 gauge needle (Brown ®, Germany) and free flow of CSF technique. Then children will receive intrathecal bupivacaine (0.5%) 0.4mg/kg body weight plus fentanyl 0.2 μg/kg in 2ml volume and it will be injected slowly over 20 seconds."
16003630|NCT02861716|Drug|Dexmedetomidine|"premedication with Ondansetron (Zofran®) 0.1 mg/kg and Diazepam ( 0.01 mg/kg ), then general anesthesia will be induced with inhalation of sevoflurane 8% in oxygen via face mask. After that intravenous cannula will be placed, and fluid therapy will be standardized during and after surgery.
~After securing the tube in place, the patients will be placed in the lateral decubitus position and a single dose of intrathecal anesthesia will be performed using a 25 gauge needle (Brown ®, Germany) and free flow of CSF technique. Then children will receive intrathecal bupivacaine (0.5%) 0.4mg/kg body weight plus dexmedetomidine 0.2 μg/kg in 2ml volume and it will be injected slowly over 20 seconds."
16003631|NCT02861703|Behavioral|Online lifestyle intervention|Online, computer-mediated interactive group-based lifestyle intervention addressing thoughts, feelings, behaviours related to eating, physical activity, and other psychosocial issues related to breast cancer survivorship (e.g., mood, body image, existential issues, social support).
16003632|NCT02861690|Drug|Liposomal Paclitaxel|Patients received Liposomal Paclitaxel 175mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.
16003633|NCT02861690|Drug|Nedaplatin|Patients received Nedaplatin80mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.
16003634|NCT02861677|Other|pharmaceutical care|
16003635|NCT02861664|Other|Stannous fluoride (SnF2)|Dentifrice containing 0.454% weight by weight (w/w) SnF2 and 0.072% w/w NaF
16003636|NCT02861664|Other|Sodium monofluorophosphate (SMFP)|Dentifrice containing 1400 ppm fluoride as SMFP
16003637|NCT02861651|Other|DNA sequencing|
16003638|NCT02861638|Device|Experimental group|Video of the exercises
16003639|NCT02861638|Device|Control group|video of nature scenes
16003640|NCT02861638|Device|Conventional physiotherapy|Mobilization, exercises and transfer practice.
16003641|NCT02861625|Behavioral|Letter of condolence and post-death medical consultation|Process of sending a letter of condolence with consultation proposition.
16003642|NCT02861612|Procedure|Nerve Transfer Surgery|Unilateral surgery will be performed under general non-paralytic anesthesia and no-tourniquet conditions to allow for responsive nerve simulation.
16003643|NCT02861599|Other|proprioceptive therapy|
16003644|NCT02861599|Other|speech therapy|
16071136|NCT02374567|Drug|Clomethiazole|
16003661|NCT02861560|Other|dHACM|Dehydrated human amnion/chorion membrane (dHACM) product and is regulated as a Human Cells, Tissues and Cellular and Tissue Based Product (HCT/P) under Section 361 of the Public Health Service Act by the Food and Drug Administration (FDA)
16003662|NCT02861547|Other|death|
16003663|NCT02861534|Drug|Vericiguat|2.5, 5.0, or 10.0 mg orally once daily
16003664|NCT02861534|Drug|Placebo for vericiguat|2.5, 5.0, or 10.0 mg orally once daily
16003665|NCT02861521|Device|Shoe lift|Subjects will be given a shoe lift post-knee replacement to correct leg length discrepancy
16003666|NCT02861521|Device|Sham|Sham shoe modification
16003667|NCT02861508|Other|Point-of-care ultrasound|
16003668|NCT02861508|Other|Usual care|
16003669|NCT02861495|Device|Humeral Compression/Distraction (CD) Nail|Surgical fixation of humeral shaft fractures with Humeral Compression/Distraction (CD) Nail implant
16003670|NCT02861482|Device|Bakri Balloon|Gradually increase the liquid volume inside Bakri Balloon to 250-500ml until bleeding is decreased or stopped
16003671|NCT02861482|Drug|Oxytocin|using oxytocin(usage:20IU oxytocin in 500ml lactated Ringer's, ivgtt to a maximum of 60IU) for the first step when dealing with PPH before laying Bakri Balloon
16003672|NCT02861482|Drug|Hemabate|using Hemabate (usage:250-500ug im) for the first step when dealing with PPH before laying Bakri Balloon
16003673|NCT02861482|Drug|Duratocin|using Duratocin (usage:100ug iv) for the first step when dealing with PPH before laying Bakri Balloon
16003674|NCT02861482|Procedure|Uterine Massage|continuous uterine massage for the first step when dealing with PPH before laying Bakri Balloon
16003675|NCT02861482|Procedure|B-lynch Suture|One of conservative surgical procedures if Bakri Balloon didn't work
16003676|NCT02861482|Procedure|Uterine Artery Embolization using sponges|One of conservative surgical procedures if Bakri Balloon didn't work
16003677|NCT02861482|Procedure|Cervical cerclage|One of conservative surgical procedures if Bakri Balloon didn't work
16003678|NCT02861482|Procedure|Hysterectomy|Hysterectomy with all the above measures not working
16003679|NCT02861482|Drug|Blood Product|transfusion of blood product if necessary no matter which surgical procedure has been taken
16003680|NCT02861469|Other|Semi-structured interviews|individual semi-structured interviews with general practitioners and family members
16003681|NCT02861456|Other|Standard Model of Care|
16003682|NCT02861456|Other|Alternative Model of Care|
16003683|NCT02861443|Behavioral|practice of colonic irrigation|
16003684|NCT02861430|Procedure|Immunochemistry and molecular biology on sentinel lymph node specimen|
16003685|NCT02861417|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo stem cell transplantation
16003686|NCT02861417|Drug|Busulfan|Given IV
16003687|NCT02861417|Drug|Cyclophosphamide|Given IV
16003688|NCT02861417|Drug|Fludarabine|Given IV
16003689|NCT02861417|Drug|Fludarabine Phosphate|Given IV
16003690|NCT02861417|Other|Laboratory Biomarker Analysis|Correlative studies
16003691|NCT02861417|Drug|Mycophenolate Mofetil|Given PO
16003692|NCT02861417|Other|Pharmacological Study|Correlative studies
16003693|NCT02861417|Drug|Tacrolimus|Given IV or PO
16003694|NCT02861417|Drug|Thiotepa|Given IV
16003695|NCT02861404|Genetic|skin flakes collection|viral status assessment of skin flakes
16003696|NCT02861391|Device|CO2 AcuPulse Laser|Each subject will receive 3 treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment.
16003697|NCT02861378|Drug|Phentolamine mesylate|Injection of 1ml at lidocaine injection site
16003698|NCT02861378|Drug|Water|Injection of 1ml of physiologic saline water at injection site
16003699|NCT02861352|Other|Diet zinc|4 mg zinc, as zinc sulfate, was added to a controlled diet; 25 mg supplemental zinc was given during the final recovery period when an ad lib diet was consumed
16003700|NCT02861339|Device|Opthalmologic measure with DM OPD scan III (Nidek)|Bilateral measure of corneal refractometry, pachymetry, topography and aberrometry
16003701|NCT02861326|Device|Gracey Curettes|
16003702|NCT02861313|Device|CM LOC attachment|CM LOC attachment
16003703|NCT02861313|Device|ball attachment|Ball attachment
16003704|NCT02861300|Drug|CB-839|Patients will receive CB-839 orally twice daily during each cycle. Each cycle will be 21 days long. Disease assessment will occur after cycle 3.
16003705|NCT02861300|Drug|Capecitabine|capecitabine will be given orally twice daily for 14-21 days of cycles. Each cycle will be 21 days long. Disease assessment will occur after cycle 3.
16003706|NCT02861287|Other|Economic evaluation|
16003707|NCT02861274|Device|pacemaker|
16003708|NCT02861261|Drug|1. Berberine hydrochloride tablets ; 2. ProMetS probiotics powder|"0.6g (6 pills) of Berberine tablets administered twice a day orally before meal ;
~4g (2 strips) of ProMetS probiotics powder administered orally every night"
16003709|NCT02861261|Drug|1. Berberine placebo tablets ; 2. ProMetS probiotics powder|"6 pills of Berberine placebo tablets administered twice a day orally before meal;
~4g (2 strips) of ProMetS probiotics powder administered orally every night"
16003710|NCT02861261|Drug|1. Berberine hydrochloride tablets; 2. Probiotics placebo powder|"0.6g (6 pills) of Berberine tablets administered twice a day orally before meal;
~2 strips of probiotics placebo powder administered orally every night"
16003711|NCT02861261|Drug|1. Berberine placebo tablets; 2. Probiotics placebo powder|"6 pills of Berberine placebo tablets administered twice a day orally before meal;
~2 strips of probiotics placebo powder administered orally every night"
16003712|NCT02861248|Procedure|Fractional micro-plasma radiofrequency treatment|After the patient's scars were subjected to a mild cleanser and 70% alcohol, a topical cream of 5% lidocaine hydrochloric acid (Beijing Ziguang Medication Manufacture Corporation Ltd, Beijing, China) was applied to the entire scar surface under occlusion for 60-90 min before treatment to achieve local anesthesia. Fractional micro-plasma radiofrequency treatment (Pixel RF, Accent XL; Alma Lasers, Caesarea, Israel) was applied using a roller tip at 50-80 watts. Three or four passes were made in different directions over each affected area. A high rolling speed of roughly 5 cm/s was manually controlled. This treatment was accompanied by an air cooler (Cryo 5; Zimmer, Warsaw, IN, USA) for pain control. All patients attended three to five treatment sessions at intervals of 8-16 weeks.
16003789|NCT02860650|Biological|MVA-BN-Filo|MVA-BN-Filo intramuscular (IM) injection at a dose of 5*10^8 infectious units (Inf U).
16003714|NCT02861235|Other|Rest technetium-99m tomoscintigraphy followed by stress technetium-99m tomoscintigraphy on the same day|with gamma-camera and D.SPECT camera, in Toulouse centre
16003715|NCT02861235|Other|Stress technetium-99m tomoscintigraphy followed by rest technetium-99m tomoscintigraphy on the same day|with gamma-camera and D.SPECT camera, in Nancy centre
16003716|NCT02861235|Other|stress technetium-99m tomoscintigraphy followed by rest technetium-99m tomoscintigraphy in two different days|with gamma-camera and D.SPECT camera, in Paris centre
16003717|NCT02861235|Other|Rest thallium-201 tomoscintigraphy with gamma-camera and D.SPECT camera|rest thallium-201 tomoscintigraphy for myocardial viability assessment
16003718|NCT02861235|Other|Rest technetium-99m tomoscintigraphy with gamma-camera and D.SPECT camera|rest technetium-99m tomoscintigraphy for myocardial viability assessment
16003719|NCT02861222|Drug|Doxorubicin|
16003720|NCT02861209|Other|Implementation of a care pathway|The care pathway will consist of procedures of care in the hospital (e.g. consultations with doctors, contact moments with nurses, ...) that describe the initiation of an oral anticancer therapy and the further follow up. The care pathway should describe how care can efficiently be organised.
16003721|NCT02861196|Procedure|Intensity modulated radiation therapy, Radical cystectomy|Postoperative Intensity modulated radiation therapy(IMRT) will be applied to effective team.Radical cystectomy will be applied to ineffective team.
16003722|NCT02861183|Device|OVT (Sodium Hyaluronate)|A Peri-osteotendinous injection of OVT will be administered into the soft tissue 1 cm from the lateral epicondyle at the point of greatest pain in two planes using a fanning technique. Two injections will be performed with a 22-25 gauge needle and spaced one week apart.
16003723|NCT02861183|Device|Saline|A Peri-osteotendinous injection of sterile saline will be administered into the soft tissue 1 cm from the lateral epicondyle at the point of greatest pain in two planes using a fanning technique. Two injections will be performed with a 22-25 gauge needle and spaced one week apart.
16003724|NCT02861170|Behavioral|Brief Mindfulness-Based Intervention|In addition to the educational materials that will be provided to all participants, the participants in the intervention group will also receive a 10-minute mindfulness-based intervention called a body scan. The body scan is a guided meditation exercise where participants are lead through focusing their attention on their body while maintaining awareness and acceptance of their sensations, emotions, and thoughts without trying to control or change them. The goal of the intervention is to increase mindfulness (i.e., moment-to-moment, non-judgmental and non-reactive awareness of sensations, emotions and thoughts), to provide self-regulation strategies, and to promote healthy and adaptive responses to stress.
16003725|NCT02861157|Behavioral|Planet T1D|Planet T1D is a mobile and web-based technology infrastructure specifically designed to (a) enhance youths' type 1 diabetes disease- and treatment-related knowledge through interactive and game-based educational materials; (b) support adherence to the treatment regimen through customized task prompts via mobile and web-based delivery; and (c) promote patient-provider communication through real-world data collection and feedback loops.
16003726|NCT02861144|Other|Ma ka hana ka ̒ike|Ma ka hana ka ̒ike is a self-management program for diabetic patients which includes 5 interactive group sessions lasting 1-1/2 hours in length delivered by community peer educators once a month for 6 months.
16003727|NCT02861144|Other|Hanapū Provider Toolbox|Hanapū Provider Toolbox is an educational tools that will aid the health care providers in guiding their patients to optimal glycemic control.
16003728|NCT02861131|Drug|Sugammadex|At the end of the surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Sugammadex will be dosed once at 2 mg/kg through an intravenous line with brisk flow
16003729|NCT02861131|Drug|Neostigmine|At the end of surgical procedure at a depth of neuromuscular blockade after the reappearance of T2 on the train-of-four, Neostigmine will be dosed once at 0.07 mg/kg to a maximum of 5 mg through an intravenous line with brisk flow. Glycopyrrolate will be administered with Neostigmine at a dose between 0.1 to 0.2 mg of Glycopyrrolate per 1.0 mg of Neostigmine administered.
16003730|NCT02861118|Other|No Intervention|
16003731|NCT02861105|Drug|LMWH|LMWH will be given on daily basis subcutaneously every 24 hours starting one day after ovum pick up till documentation of fetal life by ultrasound at 7 weeks.
16003732|NCT02861105|Other|0.9% saline solution|0.9% saline solution will be given subcutaneously every 24 hours starting one day after ovum pick up till documentation of fetal life by ultrasound at 7 weeks.
16003733|NCT02861079|Device|Foley catheter|An 18-F Foley catheter will insert into the endocervical canal and the balloon will fill with 30 mL of saline solution.
16003734|NCT02861079|Drug|PGE2|10 mg PGE2 vaginal ovul (Propess,Ferring®) will place high into the posterior vaginal fornix.
16003735|NCT02861066|Behavioral|Mindfulness-based Intervention|MBI will be delivered in group format, 120 minutes per week, for 6 consecutive weeks with 10-20 participants per group.
16003736|NCT02861053|Other|regular and moderate physical activity|regular and moderate physical activity will be done 3 times per week more than usual
16003737|NCT02861053|Other|No regular and moderate physical activity more than usual|regular and moderate physical activity will be done as usual
16003738|NCT02861040|Other|Laboratory Biomarker Analysis|Correlative studies
16003739|NCT02861040|Other|Pharmacological Study|Correlative studies
16003740|NCT02861040|Drug|Vincristine Sulfate Liposome|Given IV
16003741|NCT02861040|Drug|Volasertib|Given IV
16003742|NCT02861027|Procedure|PPTHA|The control group will receive Protocol Physiotherapeutic Total Hip Arthroplasty (PPTHA), consisting of guidelines on the care and post THA. The PPTHA, is held once a day, for 60 minutes, accompanied by a physiotherapist and has the following composition: 1 day) oral guidance and exercise to strengthen the gluteal muscles and muscles of the thigh, with recommendation for 3 repetitions of 12 movements, for each financial year. Patients are encouraged to sit outside the bed, after the exercises; Day 2) patients perform exercises the first day and begin the March training, with the aid of a Walker or crutches Canadians for the room; Day 3) patients perform exercises and are encouraged to walk in the hallway of the hospital wing. Day 4) reassessment and discharge.
16003790|NCT02860650|Biological|Ad26.ZEBOV|Ad26.ZEBOV intramuscular (IM) injection at a dose of 5*10^10 vp.
16003791|NCT02860650|Biological|Placebo|IM injection of 0.9 percent saline.
16003792|NCT02860650|Biological|MVA-BN-Filo|MVA-BN-Filo intramuscular (IM) injection at a dose of 1*10^8 Inf U.
16004958|NCT02851121|Other|Sensorial stimulations|
16003743|NCT02861027|Procedure|FES and PPTHA|The PPTHA associated with FES. The stimulation protocol of FES is performed with the patient positioned in supine position in bed. After cleaning the skin, two electrodes are positioned in the posterolateral region of the thigh in motor point of the medium gluteus muscle. The total time for application of the apparatus 30 min per day totaling more 1 min per day as suggested in specialized references. The intensity is adjusted according to the tolerance of the patient. The apparatus used is wavelength Ibramed Neurodyn Compact.
16003744|NCT02861014|Biological|Ocrelizumab|Ocrelizumab will be administered as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
16003745|NCT02861001|Device|conventional bronchoscopy|optical guidance of percutaneous tracheotomy is done by conventional bronchoscopy
16003746|NCT02861001|Device|VivaSight-SL tube|optical guidance of percutaneous tracheotomy is done by the VivaSight-SL tube
16003747|NCT02860988|Behavioral|MCCC treatment|Participants in this condition received newly-supported reentry services to enhance fatherhood and parenting for individuals with substance use issues. These services focus on responsible parenting, economic stability and mobility, and healthy marriage and relationships.
16003748|NCT02860975|Other|Inhaled Nitrogen|"To create the correct gas mixture, nitrogen tanks or membrane technology nitrogen generators will be utilized.
~Humidified, high flow, hypoxic gas by nasal cannula will allow the participant to walk short distances, eat, execute basic personal needs (e.g., use of toilette, washing, bathing etc.), or take breaks from wearing the mask."
16003749|NCT02860962|Drug|Dextromethorphan Hydrobromide|Dose as a single capsule preparation formulated by the Investigational Drug Service of MUSC specifically for the purposes of this trial.
16003750|NCT02860949|Drug|0.5% bupivacaine 100 mg, morphine sulfate 5 mg, 0.1% epinephrine 0.6 mg, and ketorolac 30 mg mixed NSS up to 100 mL|
16003751|NCT02860949|Procedure|Drug injection at Anterior soft tissue (25 mL)+Medial gutter area (25 mL)+Lateral gutter area (25 mL)+Posterior capsular infiltration (25 mL)|
16003752|NCT02860949|Procedure|Drug injection at Anterior soft tissue (34 mL)+Medial gutter area (33 mL)+Lateral gutter area (33 mL|
16003753|NCT02860936|Drug|Lenvatinib|Lenvatinib will be self orally administered at 24 mg daily, on a continuous basis in 4 week cycles until tumour progression, unacceptable toxicity or other criteria for discontinuation is met. Study drug should be taken at approximately the same time each morning.
16003754|NCT02860923|Drug|Exenatide|
16003755|NCT02860923|Drug|Placebo|
16003756|NCT02860910|Behavioral|Cognitive Behavioral Group Therapy|
16003757|NCT02860897|Drug|Premarin|Vaginal estrogen cream
16003758|NCT02860897|Drug|Vagifem|Vaginal estrogen tablet
16003759|NCT02860884|Procedure|liver biopsy|
16003760|NCT02860884|Other|infrared spectroscopy|
16003761|NCT02860871|Other|infrared spectroscopy|
16003762|NCT02860858|Biological|Intravitreous aflibercept injection|
16003763|NCT02860845|Device|Boric acid and probiotics|Vaginal capsules administered once a day during 7 days.
16003764|NCT02860845|Drug|Antibiotic (Clindamycin)|Vaginal capsules containing a reference antibiotic (when bacterial vaginosis is suspected) administered once a day during 3 days.
16003765|NCT02860845|Drug|Antifungal (Clotrimazole)|Vaginal capsules containing a reference anti-fungal (when candidiasis is suspected) administered once a day during 6 days.
16003766|NCT02860819|Drug|Veliparib|Veliparib 250mg BID, continuously
16003767|NCT02860819|Drug|Gemcitabine|Gemcitabine 800mg/m2, day 1 and 8
16003768|NCT02860819|Drug|Carboplatin|Carboplatin AUC = 4, day 1
16003769|NCT02860806|Drug|JNJ-63623872|3 mg/mL solution as intravenous (IV) infusion or a single oral 600 mg dose (2 tablets of 300 mg) under fasted conditions will be administered.
16003770|NCT02860806|Drug|Placebo|Intravenous infusion of matching placebo.
16003771|NCT02860793|Other|Bone marrow aspiration|
16003772|NCT02860793|Other|Blood sampling|
16003773|NCT02860780|Drug|prexasertib|Administered IV
16003774|NCT02860780|Drug|ralimetinib|Administered orally
16003775|NCT02860754|Other|Six-minute walk test to perform before surgery|During the outpatient preoperative assessment, eligible patients will perform the six-minute walk test.
16003776|NCT02860741|Behavioral|REJOICE|Small groups led by lay leaders undergo an 8-session faith-based behavioral activation protocol that provides individuals with education about: identifying depressive symptoms, identifying pleasurable activities, scheduling pleasurable activities, and identifying and addressing avoidant behaviors that act as barriers to completing pleasurable activities
16003777|NCT02860741|Other|Control|Churches in the control arm will receive an educational materials about identifying depressive symptoms and self-management options for addressing depressive symptoms.
16003778|NCT02860728|Behavioral|Individualized Resistance Training|Lower body resistance exercises will be prescribed in various combinations over multiple days and individually modified and progressed to achieve advances in both movement pattern, intensity, and exercise volume.
16003779|NCT02860715|Drug|GX-I7|Interleukin-7 (IL-7) is T cell growth factor that can be used for treating lymphopenia patients. GX-I7 is a protein drug recombining human IL-7 and hybrid Fc (hyFc). HyFc made by Genexine is composed of hinge-CH2 region of Immunoglobulin D (IgD) and CH2-CH3 region of Immunoglobulin G4 (IgG4). The recombined region is not exposed and each region's characteristics can reduce immunogenicity and improve the efficacy of drug. Consequently, it will be able to treat the patients with lymphopenia in effective ways.
16003780|NCT02860715|Drug|Placebo|This is the placebo of GX-I7 described above.
16003781|NCT02860702|Other|Human Milk Derived Fortifier|Human milk derived fortifier will be utilized to increase caloric intake in infants assigned to the exclusive human milk arm
16003782|NCT02860702|Other|Human/Bovine Milk|Bovine milk derived fortification
16003783|NCT02860689|Other|using questionnaires - International Index Erectile Function|using questionnaires
16003784|NCT02860676|Drug|cirmtuzumab|cirmtuzumab, dose based on ongoing phase 1 trial, q14days x 4 doses, then q28 days x 4 doses, until disease progression.
16003785|NCT02860663|Dietary Supplement|Vitamin D3|10 ug/d of vitamin D3 for 6 weeks
16003786|NCT02860663|Dietary Supplement|Vitamin D2|10 ug/d of vitamin D3 for 6 weeks
16003787|NCT02860663|Dietary Supplement|25OHD|10 ug/d of vitamin D3 for 6 weeks
16003788|NCT02860650|Biological|Ad26.Filo|Ad26.Filo intramuscular (IM) injection at a dose of 9*10^10 viral particles (vp).
16003793|NCT02860637|Other|Questionnaires|Sexual function was assessed by the International Index of Erectile Function (IIEF) and level and degree of injury were determined following the guidelines of the International Standards for Neurological and Functional Examination Classification of Spinal Cord Injury.
16003794|NCT02860624|Drug|10 mg ilaprazole|Two 5-mg ilaprazole tablets (Livzon Pharm Group Inc., China) being taken orally each morning on an empty stomach for 8 weeks
16003795|NCT02860624|Drug|40mg esomeprazole|One 20-mg omeprazole capsule (AstraZeneca, Losec) being taken orally each morning on an empty stomach for 8 weeks
16003796|NCT02860572|Other|follow-up without intervention|
16003797|NCT02860572|Other|fluid bolus|
16003798|NCT02860559|Biological|TBX-1400|Hematopoietic stem cells transplantation
16003799|NCT02860546|Drug|TAS-102|One Arm Only (of TAS 102 plus nivolumab)
16003800|NCT02860546|Drug|nivolumab|One Arm Only (of TAS 102 plus nivolumab)
16003801|NCT02860533|Device|cuff device|Measurement of blood pressure during stress testing with cuff device
16003802|NCT02860533|Device|iphone|Measurement of blood pressure during stress testing with iPhone
16003803|NCT02860507|Drug|sugammadex|
16003804|NCT02860507|Drug|Neostigmine|
16003805|NCT02860507|Drug|Glycopyrrolate|
16003806|NCT02860494|Drug|Everolimus|Everolimus topical formulation will be applied to the affected areas, once daily, in the evening, for 6 months. Dose regimens will be identical, regardless of the dose-strength of the topical formulation. The topical formulation will be applied onto areas of the face affected by FA by the patient or the patient's parents/legal guardians, while observing standardised precautions (avoiding the eyes, washing the hands after application, etc.).
16003807|NCT02860494|Drug|Placebo|Placebo topical formulation will be applied to the affected areas, once daily, in the evening, for 6 months, by the patient or the patient's parents/legal guardians, while observing standardised precautions (avoiding the eyes, washing the hands after application, etc.).
16003808|NCT02860481|Procedure|blood sample for FSHR analysis|
16003809|NCT02860481|Procedure|blood sample for FSHR analysis|
16003810|NCT02860468|Other|Cranberry juice|cranberry juice cocktail provided by Ocean Spray Cranberries, Inc.
16003811|NCT02860468|Other|Placebo juice|apple juice added with flavor and colorants provided by Ocean Spray Cranberries, Inc.
16003812|NCT02860455|Device|RAD57 measurement (SpCO)|"SpCO measurement (Experimental)
~Non invasive pulse CO-oximetry will be carried out by prehospital emergency nursing staff trained in the use of the Rad-57 pulse CO-oximeter (Masimo, Inc., Irvine, CA, USA), using the adult sized sensor (Sensor, Rev. B) placed on the 3rd or 4th digit, according to manufacturer recommendations. Nail polish will be removed if necessary. SpCO was expressed in total percentage of hemoglobin."
16003813|NCT02860455|Device|CO-oximeter|"COHb measurement (Active Comparator)
~Venous blood will be collected into EDTA treated tubes (Beckton Dickinson) prehospitally and sent to the toxicology laboratory for further carboxyhemoglobin testing. Blood carboxyhemoglobin will be analyzed by derivative spectrophotometry using an automated CO-oximeter (IL 682, Instrumentation Laboratory SpA V.le Monza 338-20128 Milan, Italy). Blood carboxyhemoglobin will be detected within a range of 0-100% and accuracy of 0.5% and reported as percentage of total haemoglobin."
16003814|NCT02860442|Behavioral|Smartphone brief intervention (SP-BI)|"Participants in the SP-BI group will receive a 20-30 minute intervention through an app program based on the FRAMES format: providing personalized Feedback (regarding substance use, risk factors), emphasis on Responsibility for change, Advice, Menu of options, Empathic clinical behaviors, and support of Self-efficacy regarding making changes. The intervention is designed to address the target behavior of alcohol use, and will include a tailored review of participants' goals/values, feedback regarding their alcohol use patterns and consequences (either actual experiences or potential based on risk behaviors), developing a discrepancy between their alcohol use and ability to meet goals and values through a decisional balance exercise, and formulation of a change plan."
16003815|NCT02860442|Other|Enhanced Usual Care (EUC)|Those assigned to EUC will receive an informational brochure with resources available to members of the military related to mental health and alcohol use. They will be contacted to complete 4-, 8-, and 12-month follow-up assessments.
16003816|NCT02860429|Drug|Cinobufacini injection|cinobufacini injection 20ml mixed with 5% Glucose injection 500ml started at the first day of chemotherapy until seven days once a day.
16003817|NCT02860429|Drug|chemotherapy|Chemotherapy is the oxaliplatin combination with fluorouracil regimen.
16003818|NCT02860403|Procedure|motor imagery|Intervention consisted of supervised MI during which the participants were trained to imagine performing a single-joint wrist extension movement and a multiple-joint reach-to-grasp movement using tenodesis. The two movements were practiced in separate blocks and each 45 minute MI session consisted of six to eight blocks. Within a given block patients; i) performed the movement once, ii) imagined it using visual imagery (between five and ten repetitions), iii) performed the movement again, and iv) imagined it using kinesthetic imagery (between five and ten repetitions). All movements (performed and imagined) were timed by the experimenter to ensure that the durations of both imagined and physically practiced movements were similar. Imagery vividness was controlled with self-rated assessments using a visual analogic scale (from 0, the image or feeling was absent, to 10 when it was as clear or intense as physical practice).
16003819|NCT02860390|Other|Denver Health Asthma Management Program|text message (SMS) support including educational, motivational, and resource content.
16003820|NCT02860390|Other|Person of Support|Subjects in the adolescent cohort will designate a support person (e.g. parent) to receive messages from the Denver Health Asthma Management Program
16003821|NCT02860377|Procedure|recorded maternal voice|"A voice recording will be performed before the operation. At a preoperative visit or preoperative clinic, informed consent was obtained before the recording. On a calm environment, the mother was asked to speak following sentences.
~OO (first name of child), wake up~. Let's go home with mommy. OO, wake up~. Open your eyes. Take a deep breath. 
~At the end of surgery, the recorded maternal voice was delivered to the child every 15 seconds until he/she wakes up."
16003822|NCT02860377|Procedure|recorded stranger's voice|"A voice recording will be performed before the operation. On a calm environment, a blinded female investigator was asked to speak following sentences.
~OO (first name of child), wake up~. Let's go home with mommy. OO, wake up~. Open your eyes. Take a deep breath. "
16003884|NCT02859935|Behavioral|Screening and feedback|Screening via questionnaires on mental health problems and feedback on the questionnaires
16003823|NCT02860364|Procedure|Hypothermic circulatory arrest|During cardiac surgery requiring circulatory arrest, the patient's body temperature is lowered significantly to reduce the cellular metabolic rate and reduce ischemic injury.
16003824|NCT02860325|Device|NIV-NAVA|Non-invasive ventilatory support by means of neurally adjusted ventilatory assist (SERVO-n, Maquet, Solna, Sweden)
16003825|NCT02860325|Device|Conventional|Non-invasive ventilatory support by means of nCPAP or non-synchronized nIPPV (Infant Flow, CareFusion)
16003826|NCT02860312|Behavioral|Intradialytic exercise on stationary bicycles|Patients are exercising for 30-60 min during dialysis on an Rated Perceived Exertion (RPE) Scale between 12 and 14
16003827|NCT02860312|Behavioral|Non-exercising group|Patients are having their usual physical activity
16003828|NCT02860299|Drug|citrate 4%|
16003829|NCT02860299|Drug|unfractionated heparin|
16003830|NCT02860299|Biological|blood sample|
16003831|NCT02860286|Drug|Tazemetostat|Tazemetostat (EPZ-6438) is a selective small molecule inhibitor of the histone-lysine methyltransferase EZH2 gene.
16003832|NCT02860273|Device|High Flow Nasal Cannula Oxygen|Exercise capacity testing according to High Flow Nasal Cannula Oxygen at 21% in COPD patients involved in a Pulmonary Rehabilitation program.
16003833|NCT02860273|Device|Treadmill|Exercise capacity testing in COPD patients involved in a Pulmonary Rehabilitation Program.
16003834|NCT02860260|Biological|Blood samples|
16003835|NCT02860260|Other|Cerebral MRI|
16003836|NCT02860234|Drug|Oxaliplatin|
16003837|NCT02860234|Drug|Capecitabine|
16003838|NCT02860234|Radiation|intensity modulated radiotherapy|
16003839|NCT02860234|Procedure|DRE-Endoscopy-MRI-CEA|
16003840|NCT02860234|Procedure|Nonoperative Management|
16003841|NCT02860234|Procedure|Local Excision|
16003842|NCT02860234|Procedure|Total Mesorectal Excision|
16003843|NCT02860234|Behavioral|Quality of Life Questionnaires|
16003844|NCT02860221|Drug|Tranexamic acid (TXA)|IV and topical administration
16003845|NCT02860221|Drug|Epinephrine|
16003846|NCT02860208|Procedure|3 years follow-up|Examination 3 years after surgical treatment of peri-implantitis
16003847|NCT02860195|Other|oral dose of alcohol|
16003848|NCT02860195|Device|alcotest|
16003849|NCT02860195|Biological|blood samples|
16003850|NCT02860195|Device|Transdermal monitor|
16003851|NCT02860182|Other|measure the elastic properties of aortic wall|
16003852|NCT02860169|Behavioral|Participants self-administered questionnaire and assessment|Participants self-administered questionnaire and assessment includes Picture Rating, Picture Surfing Task, Questionnaire and VAS scales, Cognitive Function Assessment, RTI, AST, ERT , RVP.
16003853|NCT02860130|Drug|Prismocitrate 18|Modality of CVVHDF
16003854|NCT02860130|Other|No Anticoagulation|Modality of CVVHDF
16003855|NCT02860117|Device|Ketamine continuous infusion|Ketamine 0.1% 250mL continuous infusion (0,2ml/kg/h)
16003856|NCT02860117|Drug|Placebo|Placebo continuous infusion (0,2 ml/kg/h)
16003857|NCT02860104|Device|microwave ablation|ultrasound guided percutaneous microwave ablation for breast lesions
16003859|NCT02860078|Device|Ultrasound|Location and function of sacral epidural space with ultrasound
16003860|NCT02860078|Device|Radioscopy|Location and puncture of the sacral epidural space only with fluoroscopy
16003861|NCT02860065|Drug|CPC-201|solifenacin and donepezil
16003862|NCT02860065|Other|Positron emission tomography (PET)|measure activity of cerebral acetylcholinesterase
16003863|NCT02860052|Drug|SB208 2%|Apply once daily to one or both feet for 14 days
16003864|NCT02860052|Drug|SB208 4%|Apply once daily to one or both feet for 14 days
16003865|NCT02860052|Drug|SB208 16%|Apply once daily to one or both feet for 14 days
16003866|NCT02860052|Drug|Vehicle Gel|Apply once daily to one or both feet for 14 days
16003867|NCT02860039|Biological|Trivalent Influenza Vaccine|High dose Trivalent Influenza Vaccine given intramuscular
16003868|NCT02860039|Biological|Quadrivalent Influenza Vaccine|Standard dose Quadrivalent Influenza Vaccine given intramuscular
16003869|NCT02860039|Other|Laboratory Biomarker Analysis|Correlative studies
16003870|NCT02860026|Other|Marketed cow's milk-based infant formula|
16003871|NCT02860026|Other|Cow's milk-based infant formula with added nutrients|
16003872|NCT02860013|Device|Telemedicine|
16003873|NCT02860000|Drug|Alisertib|Given PO
16003874|NCT02860000|Drug|Fulvestrant|Given IM
16003875|NCT02860000|Other|Laboratory Biomarker Analysis|Correlative studies
16003876|NCT02859987|Procedure|PICC Placement by Landmark Technique|Comparison of two different techniques for PICC Placement (Landmark versus Ultrasound-guided)
16003877|NCT02859987|Procedure|PICC Placement by Ultrasound-guided Technique|Comparison of two different techniques for PICC Placement (Landmark versus Ultrasound-guided)
16003878|NCT02859987|Device|Ultrasound Scan|Initially the nurses use ultrasound for explore venous anatomy and then they use real-time ultrasound imaging during needle placement
16003879|NCT02859974|Behavioral|Respiratory retraining for PVFMD|"Patients serve as their own controls. During a three week baseline, participants will complete the Dyspnea Index (DI), and have their heart rate, Resp. minute volume and ETCO2 on days 1 and 21 (or on the day treatment commences). Participants will complete a daily log reporting their daily symptoms. This will serve as the baseline prephase.
~Post 1 phase will include five individual therapy sessions teaching the respiratory retraining techniques over an estimated three week period.
~Post2 phase will comprise of a six week home practice phase. There will be four measuring points per participant: pre1/pre2 measurements on day 1 and 21 (or on the day therapy begins), post1 upon completing five therapy sessions and post 2 upon completion of the home practice phase."
16003880|NCT02859961|Drug|PRO 140 (350 mg)|PRO 140 350 mg (175 mg/mL) SC injection per week
16003881|NCT02859961|Drug|PRO 140 (525 mg)|PRO 140 525 mg (175 mg/mL) SC injection per week
16003882|NCT02859961|Drug|PRO 140 (700 mg)|PRO 140 700 mg (175 mg/mL) SC injection per week
16003883|NCT02859948|Drug|SKLB1028|SKLB1028 capsules in six doses beginning at 20 mg and rising to 200 mg.
16003885|NCT02859922|Device|Laryngeal Tube Suction Disposable|Laryngeal Tube Suction Disposable
16003886|NCT02859922|Device|Supreme Laryngeal Mask Airway|Supreme Laryngeal Mask Airway
16003887|NCT02859909|Biological|BT595|
16003888|NCT02859896|Drug|Doxercalciferol (GZ427397)|"Pharmaceutical form: capsule
~Route of administration: oral"
16003889|NCT02859896|Drug|Calcitriol|"Pharmaceutical form: capsule
~Route of administration: oral"
16003890|NCT02859883|Device|gastroscope FUSE™|All patients undergoing a diagnostic gastroscopy are eligible. Using the FUSE endoscope with side screen, the duodenal and accessory papilla are monitored. Data are collected by each operator. Clinical examination of patients is performed before they leave the centre.
16003891|NCT02859870|Device|FUSE-TM colonoscope|Colonoscopy in conditions of normal security including patient clinical examination before leaving the hospital. Data collection by each operator.
16003892|NCT02859857|Drug|BXQ-350|BXQ-350 is a novel anti-neoplastic therapeutic agent configured from two components: Saposin C (SapC), an expressed (human) lysosomal protein, and the phospholipid dioleoylphosphatidyl-serine (DOPS), a phospholipid located on cell membranes. When both the components are assembled together stable SapC-DOPS nanovesicles are formed(clinical formulation BXQ-350).
16003893|NCT02859844|Device|Transcutaneous Tibial Nerve Stimulation (TTNS)|
16003894|NCT02859831|Other|water samples|
16003895|NCT02859818|Other|therapeutic education program|
16003896|NCT02859805|Other|validation of a diagnostic tool severity of non-motor symptoms in Parkinson patients|
16003897|NCT02859792|Drug|Riluzole|Riluzole capsules (25 or 50 mg) will be administered in the four dose level groups (i.e. 25 mg bid; 50 mg bid; 75 mg bid; 100 mg bid).
16003898|NCT02859792|Drug|Placebo|placebo capsules 25 or 50 mg
16003899|NCT02859792|Biological|Blood Samples|v1;v2;v3;v4
16003900|NCT02859779|Behavioral|education programs|
16003901|NCT02859766|Drug|Abicipar pegol|Abicipar pegol 2 mg administered to the study eye by intravitreal injection.
16003902|NCT02859753|Other|Percutaneous Radiofrequency Ablation|
16003903|NCT02859753|Other|Percutaneous Microwave Ablation|
16003904|NCT02859740|Other|SIGAM Questionnaire|
16003905|NCT02859727|Drug|CDZ173|140 mg/day
16003906|NCT02859714|Other|screening data|
16003907|NCT02859701|Drug|AK002|IV AK002
16003908|NCT02859701|Other|Placebo|
16003909|NCT02859688|Genetic|pyrosequencing|
16003910|NCT02859688|Genetic|Methylome|
16003911|NCT02859675|Other|triangular test|metabolic state, impedance measurement, potential flavours evoked by sucrose,
16003912|NCT02859675|Biological|blood sampling|sampling of 2 mL
16003913|NCT02859675|Other|Questionnaires|Stunkard, PrefQuest
16003914|NCT02859662|Procedure|ruptured aortic aneurysm|All patients with ruptured abdominal aortic aneurysm may be included in this study, whatever the surgical treatment.
16003915|NCT02859649|Behavioral|neuropsychological test|neuropsychological test
16003916|NCT02859610|Other|research on interactions between portal hypertension and microparticles|
16003917|NCT02859597|Device|High flow nasal cannula|High flow nasal cannula at 50 liters per minute and 50% oxygen will initially be used for oxygenation.
16003918|NCT02859597|Device|Nasal Cannula|Control group will receive oxygen via standard flow nasal cannula at 5 liters per minute (approximately an FiO2 of 0.35)
16003919|NCT02859584|Biological|Measure OF SERUM TOTAL CORTISOL, SERUM FREE AND SALIVARY CORTISOL|
16003920|NCT02859571|Drug|Oxytocin|
16003921|NCT02859558|Drug|elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide or other medically-appropriate FDA-approved antiretroviral therapy|Participants will receive one tablet of elvitegravir 150mg/cobicistat 150mg/emtricitabine 200mg/tenofovir alafenamide 10mg by mouth daily with food.
16003922|NCT02859545|Behavioral|Emotional Validation Training for Romantic Partners|In this intervention, romantic partners of individuals with chronic pain are trained individually by a research assistant. The romantic partner is trained on how to validate the individual with chronic pain's pain-related distress and given education about validation. This involves an approximately 45-minute brief, interactive training.
16003923|NCT02859545|Behavioral|Chronic Pain Education Training for Romantic Partners|In this intervention, romantic partners of individuals with chronic pain are trained individually by a research assistant. The romantic partner is trained on how to ask health professionals questions about treatment options and given health education about chronic pain. This involves an approximately 45-minute brief, interactive training.
16003924|NCT02859532|Radiation|elastography SWIRE|
16003925|NCT02859519|Drug|MOB015B|MOB015B - Terbinafine hydrochloride (HCl) 10%, topical solution
16003926|NCT02859519|Drug|MOB015B Vehicle|MOB015B Vehicle without the active ingredient Terbinafine
16003927|NCT02859506|Other|Respiratory quotient|
16003928|NCT02859506|Other|Olfactory liking|
16003929|NCT02859493|Device|Saccharomyces cerevisiae|
16003930|NCT02859493|Device|Placebo|
16003931|NCT02859480|Drug|Rosuvastatin 5mg|Rosuvastatin 5mg tablet, q.d., for 30 months
16003932|NCT02859480|Drug|Rosuvastatin 20mg|Rosuvastatin 5mg tablet, q.d., for 30 months
16003933|NCT02859467|Other|Kinesio Taping and Inhibitory Treatment Techniques|"Kinesio Taping on trapezius, infraspinatus, and paravertebral muscles
~Inhibitory Treatment Techniques:
~Release Technique of the trapezius muscle.
~Release Technique for scalene muscles.
~Technique suboccipital inhibition.
~Technique hands crossed for induction dorsal superficial fascia."
16003934|NCT02859467|Other|Exercise and Electrical Stimulation Therapy|Session for general physical activities (joint mobility, muscle strength and elasticity), and electrical stimulation therapy on para vertebral muscles.
16003935|NCT02859454|Drug|Avelumab|Avelumab 10 mg/kg intravenous (IV) every 2 weeks for up to 6 doses.
16003936|NCT02859441|Drug|Ranibizumab|Intravitreal injections of the commercially-available 10 mg/mL formulation of ranibizumab. Ranibizumab is formulated as a sterile solution (pH 5.5) with histidine, trehalose and polysorbate 20. The vial contains no preservative. Each vial contains 0.5 mL of 10 mg/mL ranibizumab aqueous solution. The intravitreal injection volume of ranibizumab is 50 microliter, which correlates to 0.5 mg of dry ranibizumab.
16004021|NCT02858804|Drug|Cytarabine|2g/m2, q12h, d1
16004022|NCT02858804|Drug|Cisplatin|100mg/ m2,IV, d1
16004023|NCT02858804|Drug|Rituximab|375 mg/m2 IV, d1
16004024|NCT02858804|Drug|Thalidomide|50-150mg/d, po, d1-28
16004025|NCT02858804|Drug|Prednisone|0.5mg/Kg, po, qod
16003937|NCT02859441|Drug|E10030|E10030 is not a commercially available drug product, and will be provided by Ophthotech Corp. The drug product is provided as a sterile aqueous solution of E10030 at a concentration of 30 mg (oligo weight)/mL. The solution contains monobasic sodium phosphate monohydrate and dibasic sodium phosphate heptahydrate as buffering agents as well as sodium chloride as a tonicity adjuster. The intravitreal injection volume of E10030 is 50 microliter, which correlates to 1.5 mg of dry E10030.
16003938|NCT02859415|Drug|Mithramycin|Phase 1: 24 hour intravenous infusion of mithramycin given once every 14 days at escalating doses; Phase 2: 24 hour intravenous infusion of mithramycin given once every 14 days at MTD established in phase 1
16003939|NCT02859402|Drug|Busulfan|intravenous, 3.2 mg/kg + 5% DW (the diluent quantity should be 10 times the volume of Busulfan, so that the final concentration of busulfan becomes approximately 0.5 mg/mL), once daily for 3 hours for 3 days (days -7 to -5)
16003940|NCT02859402|Drug|Fludarabine|intravenous, 30 mg/m2 + 5% DW 100㎖, over 1 hour once daily for 6 days (days -8 to -3)
16003941|NCT02859376|Dietary Supplement|sucrose 24%|Premature neonates undergoing blood samples through skin breaking procedures, meeting inclusion criteria, will be randomized as soon as the doctor decision to drown the blood is made, to either sucrose 24% 0,3 mL if < 1000 g or 0,5 mL if > 1000 g two minutes BEFORE the skin breaking procedure or sucrose 24% 0,3 mL if < 1000 g or 0,5 mL if > 1000 g two minutes BEFORE and DURING the skin breaking procedure, according to a computer generated randomization list.
16003942|NCT02859363|Genetic|26 common Fabry mutation types in Taiwan|Historical DNA samples from projects 103-3254C (98-3889A3) and 100-4008C (97-0470B) will perform specific genetic testing.
16003943|NCT02859350|Biological|PfSPZ Vaccine|Metabolically active, non-replicating, radiation attenuated, aseptic, purified, cryopreserved NF54 P. falciparum (Pf) sporozoites (PfSPZ Vaccine)
16003944|NCT02859350|Biological|PfSPZ Challenge (for CHMI)|live, infectious, aseptic, purified, cryopreserved NF54 P. falciparum (Pf) sporozoites (PfSPZ Challenge) Controlled human malaria infection (CHMI) by direct venous inoculation of 3,200 PfSPZ Challenge
16003945|NCT02859350|Other|Normal Saline|0.9% Sodium chloride
16003946|NCT02859350|Biological|PfSPZ Challenge (for PfSPZ-CVac)|live, infectious, aseptic, purified, cryopreserved NF54 P. falciparum (Pf) sporozoites (PfSPZ Challenge)
16003947|NCT02859337|Drug|UPA-ECx1|Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 30mg of UPA-based EC
16003948|NCT02859337|Drug|UPA-ECx2|Evaluating the pharmacodynamic and pharmacokinetic outcomes in obese women using 60mg of UPA-based EC
16003949|NCT02859324|Drug|CC-122|
16003950|NCT02859324|Drug|Nivolumab|
16003951|NCT02859311|Drug|Withdrawal of therapy|Withdrawal of heart failure therapies (angiotensin converting enzyme inhibitors, angiotensin receptor blockers, beta-blockers, mineralocorticoid receptor antagonists and loop diuretics)
16003952|NCT02859298|Device|Uterine Cervix Polarimetric Imaging|Polarimetric imaging is a promising optical technique that can provide information in large field and potentially in vivo about the abundance and 3D structure of collagen. Images will be taken with a polarimetric colposcope. As the imaging is realized with visible light from classical sources (lamps or LEDs, neither lasers or other high intensity sources, nor any ionizing UV radiation) and without any chemicals, it is totally innocuous, just like the intensity imaging used in conventional colposcopy.
16003953|NCT02859285|Other|Placebo vulvar cream|
16003954|NCT02859285|Other|Estradiol vulvar cream|
16003955|NCT02859259|Drug|BMS-663068 (1 tablet at 600 mg)|BMS-663068 (1 tablet at 600 mg). A single dose of BMS-663068 administered orally as specified.
16003956|NCT02859259|Drug|BMS-663068 (4 tablets at 150 mg each tablet)|BMS-663068 (4 tablets at 150 mg each tablet). A single dose (4 tablets) of BMS-663068 administered orally as specified.
16003957|NCT02859246|Drug|Mucinex®|Mucinex®
16003958|NCT02859233|Other|Lack of hyperhydration|
16003959|NCT02859220|Other|Determination of PTH following|"Determination of PTH following:
~in group 1: intact PTH Elecsys Roche"
16003960|NCT02859220|Other|Determination of PTH following:|"PTH 1-84 complete (PAC) report and CAP / CIP, the package Duo PTH IRMA Scantibodies. The CIP is obtained by calculating the difference between total intact PTH and PTH 1-84 in the kit used."
16003961|NCT02859207|Drug|E2609|Participants will receive a single 50-mg dose (1× 50-mg E2609 tablet).
16003962|NCT02859194|Procedure|Veno-veno-arterial ECMO|
16003963|NCT02859181|Dietary Supplement|Amino Acid Intake|Amino acid intakes will be varied at 0.2-2.67 g/kg/d
16003966|NCT02859155|Procedure|Multivisceral en bloc resection surgery|Multivisceral en bloc resection for colorectal cancer in advance patients (T4)
16003967|NCT02859142|Drug|Chantix|Chantix given alongside standard smoking cessation treatment, and administered per manufacturer's instructions [0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then one 1.0 mg tablet twice per day]
16003968|NCT02859142|Behavioral|Behavioral Counseling Sessions|One-to-one behavioral counseling sessions with a trained therapist
16003969|NCT02859142|Drug|NicodermCQ|Nicotine patches provided over 12 week participation
16003970|NCT02859142|Drug|Placebo|Identical in appearance to varenicline [0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then one 1.0 mg tablet twice per day]
16003971|NCT02859129|Drug|rosuvastatin 40 mg tablet|Single oral dose of 40 mg (1 x 40 mg tablet) rosuvastatin (Crestor®) (Day 1).
16003972|NCT02859129|Drug|Epanova™ QD (2 x 1 g capsules)|Multiple oral doses of 2 g (2 x 1 g capsules) Epanova™ QD for 10 consecutive days (Days 4 to 13)
16003973|NCT02859129|Drug|Multiple doses of 4 g Epanova™ with single of rosuvastatin 40 mg dose|Multiple oral doses of 4 g Epanova™ QD for 13 consecutive days with coadministration of single 40 mg oral dose of rosuvastatin (Crestor®) with the 11th dose of Epanova™ on Day 24
16003974|NCT02859129|Drug|Multiple (20) oral doses of 2 g Vascepa® every 12 hours|Multiple oral doses of 2 g (2 x 1 g capsules) Vascepa® every 12 hours for 20 consecutive days (Days 1 to 20).
16004026|NCT02858778|Other|Early order of palliative care consultation|
16004027|NCT02858765|Other|Application of white polychromatic light for 2h30 at different times of day|
16003975|NCT02859116|Procedure|Collection of digestive tissues|The surgeon will resect a sample (approximately 1-5 cm x 1-5 cm) of healthy tissue from the distal margins of the segment and at least 4 cm from the diseased area. The specimen for research will be obtained from the tissue that would ordinarily be removed during surgery.The tissue collected for our research purposes will be only remnant tissue which is discarded by the surgeon during the surgical intervention and has no diagnostic clinical value.
16003976|NCT02859103|Drug|Desvenlafaxine|Patients will be provided 50mg dose of desvenlafaxine for 1 week titrated up to 100mg dose of desvenlafaxine for 7 weeks.
16003977|NCT02859090|Procedure|tonsillectomy|
16003978|NCT02859090|Biological|blood sample|
16003979|NCT02859077|Drug|EGFR-TKI|EGFR-TKI (gefitinib)
16003980|NCT02859077|Drug|Chemotherapy（pemetrexed/gemcitabine）|Chemotherapy (pemetrexed/gemcitabine)
16003981|NCT02859077|Drug|Chemotherapy（carboplatin）|Chemotherapy（carboplatin）
16003982|NCT02859064|Drug|Lanreotide|Administered every 28 days irrespective of when SIR-Spheres is administered. No waiting or adjusting of schedule is required. Lanreotide treatment may continue monthly until disease progression or unacceptable toxicity occurs.
16003983|NCT02859064|Device|Y-90 microspheres|To be administered by injection through a trans-femoral catheter into the hepatic artery.
16003984|NCT02859051|Device|Humanoid Robot MEDi|Humanoid robot programmed with cognitive-behavioral interventions such as role modeling, teaching coping strategies, positive reinforcement, parent encouragement
16003985|NCT02859038|Procedure|Upfront cytoreductive surgery|Upfront cytoreductive surgery with a maximum cytoreduction, then followed by 6 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5
16003986|NCT02859038|Procedure|Interval debulking surgery|3 cycles of Paclitaxel 175mg/m2 or Docetaxel 60-75 mg/m2 plus Carboplatin AUC (area under the curve) 5, Interval debulking surgery with a maximal cytoreduction of complete gross resection, then followed by another 3 cycles of chemotherapy
16003987|NCT02859025|Biological|anterior iliac crest graft|Anterior iliac crest spongy bone filled the defects followed by coverage with collagen membrane.
16003988|NCT02859025|Biological|lateral ramus cortical bone+BFPSC+NBBM|ramus cortical bone cage created a protected healing space and BFPSCs cultured over NBBM were put over the graft.
16003989|NCT02859025|Biological|anterior iliac crest graft+BFPSC+NBBM|Anterior iliac crest spongy bone filled the defects and BFPSCs cultured over NBBM were put over the spongy bone.
16003990|NCT02859012|Drug|Axitinib|Dosing schedule: 5mg twice per day orally (4 weeks is considered as 1 cycle)
16003991|NCT02859012|Other|Observation|this group is observational ones.
16003992|NCT02858999|Drug|PAD-VCD|12 weeks of induction chemotherapy by liposomal Bortezomib-Dexamethasone-Doxorubicin (PAD) alternating with Bortezomib-Dexamethasone-Cyclophosphamide (VCD) for a total of 4 cycles
16003993|NCT02858986|Procedure|3D laparoscopy|
16003994|NCT02858986|Procedure|4K laparoscopy|
16003995|NCT02858973|Drug|Q203|
16003996|NCT02858973|Drug|Placebo|
16003997|NCT02858960|Device|High Flow Nasal Cannula Oxygen|Exercise capacity testing according to High Flow Nasal Cannula Oxygen in COPD patients involved in a Pulmonary Rehabilitation program.
16003998|NCT02858960|Device|The Venturi Mask|Exercise capacity testing according to the oxygen Mask Venturi in COPD patients involved in a Pulmonary Rehabilitation program.
16003999|NCT02858947|Procedure|Aelite Flo|Microhybrid flowable composite
16004000|NCT02858947|Procedure|x-tra base|Bulk-fill flowable composite
16004001|NCT02858934|Radiation|Tomotherapy|"Dose prescription:
~Whole breast irradiation: 25 Gy in 5 daily fractions of 5 Gy Boost: 30 Gy in 5 daily fractions of 6 Gy The boost will be delivered as a simultaneous integrated boost (SIB).
~Target volumes:
~Clinical target volume (CTV) breast: defined by the soft tissue of the breast down to the pectoralis fascia, but excluding the skin and the underlying muscle, ribs, lung and heart.
~Gross tumor volume (GTV) boost: includes all gross tumor volume, as visible on computer tomography, mammography and/or magnetic resonance imaging (MRI). MRI imaging is preferentially performed in treatment position.
~CTV boost: includes the primary tumor, with a margin of 1.0 cm in all directions to encompass potential microscopic disease extension. The CTV boost excludes the skin, pectoralis muscle, ribs, lung and heart.
~Planning target volume (PTV): CTV plus a margin of 5 mm in all directions, but limited at 5 mm below the skin surface."
16004002|NCT02858921|Drug|Dabrafenib|Dabrafenib, a 4-(3-aminosulfonylphenyl)-5-(pyrimidine-3-yl) thiazole, is a potent and selective inhibitor of B-RAF kinase activity with a mode of action consistent with adenosine triphosphate (ATP)-competitive inhibition, and is approved as monotherapy in BRAF V600E-mutant advanced/metastatic melanoma.
16004003|NCT02858921|Drug|Trametinib|Trametinib, a pyrido - pyrimidine derivative, is a potent and highly selective allosteric non-competitive inhibitor of MEK1/MEK2 activation and kinase activity has been approved as monotherapy in BRAF (V600E)-mutant and BRAF (V600K)-mutant melanoma.
16004004|NCT02858921|Drug|Pembrolizumab|Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
16004005|NCT02858908|Drug|Tideglusib|Tideglusib for oral suspension,
16004006|NCT02858895|Drug|MDNA55|MDNA55 is an engineered circularly permuted interleukin-4 (cpIL-4) genetically fused to the catalytic domain of the pseudomonas exotoxin A (PE).
16004007|NCT02858882|Other|Screening|Screening of elite swimmers
16004008|NCT02858869|Biological|Pembrolizumab|Given IV
16004009|NCT02858869|Radiation|Stereotactic Radiosurgery|Undergo SRS
16004010|NCT02858856|Drug|Sipjeondaebo-tang|Herbal medicine which is a compound of 10 herbs.
16004011|NCT02858843|Drug|lumacaftor-ivacaftor|Drug given for cystic fibrosis
16004012|NCT02858830|Other|High fat mixed meal|
16004013|NCT02858817|Drug|atovaquone/proguanil 250mg/100mg (A/P)|Combination drug for chemo-prophylaxis or treatment of malaria
16004014|NCT02858817|Biological|PfSPZ Challenge (NF54)|cryo-preserved Plasmodium falciparum sporozoites injected by venous inoculation
16004015|NCT02858817|Other|NaCl 0,9%|0.9% NaCl solution for injection
16004016|NCT02858804|Drug|Etoposide|50 mg/m2, IV d1-4
16004017|NCT02858804|Drug|Doxorubicin|10 mg/m2, IV, d1-4
16004018|NCT02858804|Drug|Dexamethasone|30 mg/d, d1-5
16004019|NCT02858804|Drug|Vincristine|0.4 mg/m2, IV, d1-4
16004020|NCT02858804|Drug|Cyclophosphamide|750 mg/m2 ,d5
16004028|NCT02858752|Other|Experience 1 : Auditory and Visual Discrimination|Neuropsychological tests consist in listening to sounds in various contexts and providing behavioral responses with response-buttons.
16004029|NCT02858752|Other|Experience 2 : Passive and Active Auditory Perception|Neuropsychological tests consist in listening to sounds under 2 conditions, an active or a passive one, during which different auditory stimuli will be presented: frequent stimuli (standard) and rare stimuli (deviants). These two stimuli differ in some of their feature (height, duration, …). A third, very rare (novel) stimulus will also be used (the subject's first name). Responses will be provided using a response-button and feedback will be given at each response. EEG will be recorded all along to measure Neurophysiological signals.
16004030|NCT02858752|Other|Experience 3 : Visual Attention Training|This experience aims at training visual attention through serious games. Children will play against an artificial intelligence and will focus their attention on one out of many possible targets (checkers, cards, boxes) presented on screen. Responses will be provided using a response-button, sometimes completed by an eye-tracking measure. Feedback will be given to the child after his response. EEG will be recorded all along to measure Neurophysiological signals.
16004031|NCT02858752|Other|Experience 4 : Attention and Distractibility|Neuropsychological tests consist in listening to sounds preceded by a visual cue indicating (or not) in which ear the sounds will be played. The subject Child should detect the target sound (e.g. a dog barking). In some trials, a distracting distraction will be introduced between the visual cue and the target sound. Responses will be provided using a response-button. EEG will be recorded all along to measure Neurophysiological signals.
16004032|NCT02858752|Other|Experience 5 : Sustained Visual Attention|Neuropsychological tests consist in watching visual stimuli presented in 3 blocks of 3 minutes each, with a break of one minute between each block. The child has to detect the presence of a red letter in a pattern made of four letters (the three other letters are black). Behavioral responses will be provided using a response-button. EEG will be recorded all along to measure Neurophysiological signals.
16004033|NCT02858739|Device|BIOFREEDOM STENT|
16004034|NCT02858726|Drug|CR845 0.5 mcg/kg|IV medication delivered three times/week
16004035|NCT02858726|Drug|CR845 1 mcg/kg|IV medication delivered three times/week
16004036|NCT02858726|Drug|CR845 1.5mcg/kg|IV medication delivered three times/week
16004037|NCT02858726|Drug|Placebo|IV medication delivered three times/week
16004038|NCT02858713|Drug|Calcipotriene + Betamethasone Dipropionate|Participants received Calcipotriene + Betamethasone Dipropionate once daily when needed for the entire study period.
16004039|NCT02858713|Device|App|App named MyPso SmarTopTM Version 1.0 (LEO Pharma) was used for 28 days by participants in the intervention arm.
16004040|NCT02858700|Biological|dosage of the umbilical cord blood Procalcitonin for diagnosing of IBNP|
16004041|NCT02858687|Other|Nasopharyngeal swab|
16004042|NCT02858674|Other|Pop Up Interruption Alert|Traditional Pop Up Alert used in Epic
16004043|NCT02858674|Other|Side Bar Non Interruptive Provider Checklist|Noninterruptive alert that sits in the checklist
16004044|NCT02858661|Other|Nasopharyngeal swab|
16004045|NCT02858648|Behavioral|Behavior intervention with smart phone based self-monitoring|Use two smartphone applications for self-monitoring of diet, physical activity, weight, and blood glucose (connected via a blue-tooth enabled glucometer), plus 11 group session and 1 individual session focused on behavioral strategies
16004046|NCT02858648|Behavioral|Behavior intervention with paper diary based self-monitoring|Use paper diaries along with a calorie counter booklet, weight scale, food scale, and pedometer for self-monitoring of diet, physical activity, weight, and blood glucose, plus 11 group session and 1 individual session focused on behavioral strategies
16004047|NCT02858635|Other|Clinical and neuropsychological assessment, Blood and saliva samples|Clinical and neuropsychological assessment: impulsivity, aggressiveness, psychological pain, angor with specific scales and smartphone.
16004048|NCT02858622|Drug|bupivacaine|bupivacaine 0.25% at a dose 2 mg/kg in the transversus abdominis plane
16004049|NCT02858622|Drug|Pethidine|pethidine intravenous at a dose 1mg/kg when pain score more than 5 postoperative rescue analgesia
16004050|NCT02858622|Drug|perfalgan|intravenous paracetamol
16004051|NCT02858622|Drug|fentanyl|
16004052|NCT02858609|Other|Nasopharyngeal Swab|
16004053|NCT02858596|Dietary Supplement|Semi-solid feed (Terumo PG soft)|
16004054|NCT02858596|Dietary Supplement|Liquid feed (Meibalance)|
16004055|NCT02858583|Procedure|CC+SI|chest compression will be delivered during sustained inflation (CC+SI). The duration of each sustain inflation is 20sec. After 20sec a pause of 1sec id done before the next sustained inflation is delivered for another 20sec. Chest compressions are given continuously. This approach is continued until return of spontaneous circulation.
16004056|NCT02858583|Procedure|3:1 C:V|During 3:1 C:V. 3 chest compressions are given, then stopped and then 1 inflation is given. This approach is continued until return of spontaneous circulation.
16004057|NCT02858570|Biological|MenCC-BIO Vaccine|The Bio-MenCC vaccine is composed of serogroup C meningococcal polysaccharide conjugated to tetanus toxoid as the carrier protein, with 10 microgram of capsular polysaccharide of group C, 10-20 microgram of tetanus toxoid per dose and aluminum hydroxide at a concentration of 1 milligram dose (0.35 milligram Al3 +) with phosphate buffered saline as diluent. The vaccine is lyophilized and must be reconstituted with diluent and homogenized at the time of application. The lyophilised vaccine is presented as a white powder and the sterile diluent is translucent. Both are presented in vial of colorless neutral glass.
16004058|NCT02858570|Biological|Combined - CRM197|The comparison is against meningococcal C vaccine produced by the Foundation Ezequiel Dias (FUNED), licensed by ANVISA and currently provided by the National Immunization Program in the child's immunization schedule. This vaccine containing 10 microgram of meningococcal C oligosaccharide conjugate 12,5-25microgram of CRM197 protein of Corynebacterium diphtheriae, and presents aluminum hydroxide (0.3 to 0.4 milligram Al3 +) in its formulation. It is also a lyophilized product must be reconstituted and homogenized before use. The meningococcal C vaccine adsorbed (combined - CRM197) comprises two frascos- ampoule, containing a white or off-white lyophilized powder and another vial containing a white opalescent suspension (diluent).
16004059|NCT02858557|Behavioral|Mediterranean diet|The Mediterranean diet is rich in complex carbohydrates and fibers and low in animal proteins and fats.
16004097|NCT02858297|Drug|triamcinolone acetonide|Topical corticosteroid
16004098|NCT02858284|Device|TUG|Therapeutic Ultrasound for Glaucoma
16004060|NCT02858557|Behavioral|Specific Carbohydrate Diet|The specific carbohydrate diet is a dietary program popular among patients with IBD. The diet allows carbohydrate foods consisting of mono-saccharides only, and excludes di-saccharides and most polysaccharides.
16004061|NCT02858544|Other|The Concussion Identification Index|Patient completion of the Concussion Identification Index, a report of crash characteristics, injuries sustained, and post-accident neurological signs and symptoms
16004062|NCT02858544|Other|ImPACT|Patient- completed computerized neurocognitive test battery
16004063|NCT02858531|Other|data retrieval|data retrieval with the Hospital Information System
16004064|NCT02858518|Other|questionnaires|scales : HEMORR2HAGES (hepatics diseases, alcoholism, cancer, thrombocytopenia, anemia and antecedent...), HAS-Bled (arterial hypertension, renal function, liver function, cerebrovascular accident...), ATRIA (anemia, serious kidney diseases, hypertension, antecedent...), Shireman (gender, age, hemorrhage, diabetes, anemia...), Charlson (age, cardiovascular disease, lung disease, neurological disease, endocrinal disease, nephrology, liver disease, gastroenterology, cancer) and standardised geriatric assessment (comorbidities, cognition, mobility, pain, nutrition, living environment...)
16004065|NCT02858505|Drug|27 mg elemental iron|
16004066|NCT02858505|Drug|54 mg elemental iron|
16004067|NCT02858492|Drug|GSK2982772 60 mg|GSK2982772 is available as a 30 mg white to almost white, round film coated tablet which will be administered as two tablets thrice daily as directed.
16004068|NCT02858492|Drug|Placebo|Placebo is available as a white to almost white, round film coated tablet which will be administered as two tablets thrice daily as directed.
16004069|NCT02858479|Other|stimulation on painful area (area allodynic)|"these stimulations will be performed either with a brush, with a cold block or with forced air (cold air or air to ambient temp) : calibrated to induce pain bearable.
~stimulations for 6 seconds"
16004070|NCT02858479|Other|same stimulation on non-painful area|"these stimulations will be performed either with a brush, with a cold block or with forced air (cold air or air to ambient temp) : calibrated to induce pain bearable.
~stimulations for 6 seconds"
16004071|NCT02858479|Radiation|MRI scan|"2 sessions for 10 minutes :
~11 controls stimulations for 6 s each spaced 20 s without stimulation.
~11 allodynic stimulations for 6 s each spaced 20 s without stimulation."
16004072|NCT02858466|Radiation|MRI scan|
16004073|NCT02858453|Drug|AQX-1125 100 mg|Synthetic SHIP1 activator
16004074|NCT02858453|Drug|AQX-1125 200 mg|Synthetic SHIP1 activator
16004075|NCT02858453|Drug|Placebo|Appearance and weight matched placebo tablets
16004076|NCT02858440|Biological|Infanrix-IPV/Hib|Subjects receive Infanrix-IPV/Hib three-dose primary vaccination course at 3, 4.5 and 6 months of age and a booster dose at 18 months of age. The vaccine is administered intramuscularly into the upper side of the thigh on the right/left side.
16004077|NCT02858427|Behavioral|eye tracking|"several oculomotor parameters will be recorded using vide-oculography techniques (eye tracking) trough different tasks: saccade, antisaccade, and picture scanning.
~Saccade task: the patient is looking at a screen and is asked to fix his gaze as quickly and accurately as possible on the red dot appearing on the periphery of the screen.
~Prosaccade task: the patient is looking at a screen and is asked to fix his gaze as quickly and accurately as possible on the opposite side relative to the red dot appearing on the periphery of the screen.
~Picture Scanning: participant is instructed to freely watch pictures with different emotional valence."
16004078|NCT02858427|Behavioral|neuropsychological assessement|the neuropsychological assessment aims to identify any impairment of executive functioning through several tasks: Mini mental state examination (mmse), isaac set test (STI) trail making test (TMT A and B), Grober test, Stroop test, verbal fluency, Go No Go task, memory impairment screen (MIS), picture naming test (DO30), copying figure test, digit span and categorical matching test.
16004079|NCT02858427|Behavioral|psychiatric assessment|this evaluation aims to characterize the mental status of the patient. Different scales will be used: Montgomery and ASberg depression rating scale (MADRS), Columbia-suicide severity rating scale (C-SSRS), Beck depression inventory (BDI), Barratt impulsiveness scale (BIS-10), Buss and Durkee Hostility Inventory (BDHI), Balloon, analogue risk task (BART), Iowa gambling task (IGT), and Childhood trauma questionnaire (CTQ).
16004080|NCT02858427|Behavioral|sociological interview|this interview aims to characterize social interactions of the patients, their duration, their evolution and the perception of each participant on this subject.
16004081|NCT02858414|Other|additional blood sample|
16004082|NCT02858401|Drug|Vesatolimod|Tablet(s) administered orally once every 2 weeks
16004083|NCT02858401|Drug|Placebo|Tablet(s) administered orally once every 2 weeks
16004084|NCT02858401|Drug|ARV regimen|Participants' current ARV regimen must be used in accordance with their prescribing information and may include the following: nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs), raltegravir, dolutegravir, rilpivirine, and maraviroc.
16004085|NCT02858388|Device|Sinuclean Nebules 45|Nebulization of solution
16004086|NCT02858388|Other|Saline solution|Nebulization of solution
16004087|NCT02858362|Drug|Ezutromid|Administered orally.
16004088|NCT02858349|Behavioral|No intervention|No intervention
16004089|NCT02858349|Behavioral|High-intensity interval training|High-intensity walking exercise using bursts of concentrated effort alternated with recovery periods
16004092|NCT02858310|Biological|E7 TCR cells|T cells genetically engineered with a TCR targeting HPV-16 E7 (E7 TCR) that display specific reactivity against HLA-A2+, HPV-16+ target cells
16004093|NCT02858310|Drug|Aldesleukin|Following cell infusion the patient receives high-dose bolus aldesleukin, which is dosed to individual patient tolerance. Aldesleukin improves the survival of E7 TCR cells after infusion.
16004094|NCT02858310|Drug|Fludarabine|Part of the non-myeloablative lymphocyte-depleting preparative regimen.
16004095|NCT02858310|Drug|Cyclophosphamide|Part of the non-myeloablative lymphocyte-depleting preparative regimen.
16004096|NCT02858297|Drug|Glucosamine sulfate|Glucosamine (GlcN) is an N-deacetyl amino sugar derived from the complete hydrolysis of chitosan with recently reported immunoregulatory capacity and anti-inflammatory effect
16004101|NCT02858258|Drug|R-CHOP/R-DHAP|Drug: R-CHOP/DHAP Alternating 3x R-CHOP (Rituximab , Cyclophosphamide ,Doxorubicine ,Vincristine , Prednisone) / 3x R-DHAP (Rituximab , Dexamethasone, Ara-C, Cisplatine, G-CSF)
16004102|NCT02858258|Drug|Ibrutinib (Induction)|Ibrutinib: only in cycle 1,3,5 on Day 1-19
16004103|NCT02858258|Drug|ASCT conditioning|"ASCT conditioning THAM or BEAM, stratified per site before trial activation at site
~THAM (TBI (total body irradiation), Ara-C, Melphalan) or
~BEAM (BCNU, Etoposide, Cytarabine, Melphalan)"
16004104|NCT02858258|Drug|Ibrutinib (Maintenance)|Ibrutinib (Maintenance), daily 560 mg for 2 years;
16004105|NCT02858245|Other|No intervention - registry|
16004106|NCT02858232|Biological|MASCT-I|Dendritic cells(DC) loaded with antigens ih day 8, cytotoxic T lymphocytes ( CTL) induced by DC IV day 21-28, every 28 days until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
16004107|NCT02858219|Drug|Botulinum Toxin Type A|
16004108|NCT02858219|Other|Saline solution|
16004109|NCT02858219|Other|Indexes|Visual Analogic Scale (VAS), Female Sexual Function Index (FSFI), Dermatology Life Quality Index (DLQI)
16004110|NCT02858206|Radiation|IMRT simultaneous integrated boost|To achieve a prophylactic dosage and radical dosage of 1.8Gy and 2.14Gy once respectively
16004111|NCT02858206|Drug|Nimotuzumab|nimotuzumab 400mg per week which start from 1 week before radiotherapy and in the following 4 weeks
16004112|NCT02858206|Drug|Paclitaxel|Paclitaxel from 45 to 60 mg/m2 per week which start from 1 week before radiotherapy and in the following 4 weeks
16004113|NCT02858206|Drug|Nedaplatin|Nedaplatin 25mg/m2 per week which start from 1 week before radiotherapy and in the following 4 weeks
16004114|NCT02858206|Procedure|Esophagectomy|Radical esophagectomy 4-6 weeks after neoadjuvant therapy
16004115|NCT02858193|Drug|1.35 g SCMC- lys powder|1.35 g SCMC- lys powder for oral solution
16004116|NCT02858193|Drug|Fluifort® syrup|SCMC-lys Syrup 90 mg/ml
16004117|NCT02858180|Drug|Sofosbuvir/ledipasvir fixed dose combination(SOF/LDV FDC)|1 pill once daily of SOF/LDV FDC
16004118|NCT02858167|Device|FDG-PET|FDG injection followed by cerebral examination with X ray spiral CT after 40 minutes and FDG-PET after 60 minutes
16004119|NCT02858154|Other|HFNC|All subjects will have a 3-4 hour intervention of HFNC to test effectiveness and safety for treating OSA
16004120|NCT02858154|Other|Low flow oxygen by nasal cannula|All subjects will have a 6 to 8 hours intervention during the clinically scheduled PSG of titration of oxygen by nasal cannula (standard of care) to manage sleep apnea
16004121|NCT02858141|Other|Data collection|
16004122|NCT02858128|Other|IMAGING STUDY|Choline-PET/CT versus NMRscan comparative study
16004123|NCT02858115|Other|Fluid challenge|100 ml of crystalloid was infused over 1-min
16004124|NCT02858115|Other|Trans-oesophageal echography|an echocardiographic assessment at 1-min,
16004125|NCT02858102|Behavioral|Physical activity program|The intensity of physical activity will be adapted to the possibilities of the participants making individualized proposals to encourage participants to acquire active lifestyle habits to improve their health. All sessions end with a routine of relaxation and passive stretching. Simultaneously self-employment is controlled outside the guided sessions.
16004126|NCT02858076|Drug|2-mg Intravitreous Aflibercept Injection|Soluble decoy receptor fusion protein that has a high binding affinity to all isoforms of VEGF as well as to placental growth factor.
16004127|NCT02858076|Procedure|Prompt Vitrectomy Plus Panretinal Photocoagulation|Surgical removal of the vitreous gel and associated hemorrhage, concurrent delivery of panretinal endolaser
16004128|NCT02858050|Device|Portal-724 MEMs Cap|
16004129|NCT02858037|Combination Product|Dapivirine Vaginal Ring|Dapivirine Vaginal Ring, 25 ring given monthly for at least one year.
16004130|NCT02858024|Drug|Dapivirine Vaginal Ring-004 and no tampons|Dapivirine Vaginal Ring-004 for 28 days, with menses, no tampon use (Treatment A),
16004131|NCT02858024|Drug|Dapivirine Vaginal Ring-004 with tampons|followed by Dapivirine Vaginal Ring-004 for 28 days, with menses, with tampon use (Treatment B)
16004132|NCT02858024|Drug|Dapivirine Vaginal Ring-004 with no menses|Dapivirine Vaginal Ring-004 for 28 days, with no menses occurring (Treatment E; treatment period 3).
16004133|NCT02858024|Drug|Dapivirine Vaginal Ring-004 and same ring inserted after menses|Dapivirine Vaginal Ring-004 used continuously until the start of menses, at which time the ring will be removed, and the same ring re-inserted five days later (estimated completion of menses) (Treatment C)
16004134|NCT02858024|Drug|Dapivirine Vaginal Ring-004 and new ring inserted after menses|Dapivirine Vaginal Ring-004 used continuously until the start of menses, at which time the ring will be removed, and a new ring inserted five days later (estimated completion of menses) (Treatment D)
16004135|NCT02858011|Other|Cash distribution during first 36 months|Three-monthly distribution of Cash (30,000 FCFA/trimester) to households that are beneficiary of the Jigisemejiri program.
16004136|NCT02858011|Behavioral|Accompanying information sessions on health, child nutrition, household economics and education during first 36 months|Large group gatherings of cash beneficiaries are organized in parallel to the cash distributions. During these meetings, local NGOs present and discuss a topic related to health, child nutrition, household economics or education.
16004137|NCT02858011|Dietary Supplement|Preventive Nutrition Packages during last 12 months|Fortified flour supplements for children (Supercereal Plus)and pregnant/lactating mothers (super Cereal)
16004138|NCT02858011|Other|Cash distribution during the last 12 months|Three-monthly distribution of Cash (30,000 FCFA/trimester) to households that are beneficiary of the Jigisemejiri program.
16004139|NCT02858011|Behavioral|Accompanying information sessions on health, child nutrition, household economics and education during the last 12 months|Large group gatherings of cash beneficiaries are organized in parallel to the cash distributions. During these meetings, local NGOs present and discuss a topic related to health, child nutrition, household economics or education.
16004140|NCT02857998|Drug|HMPL-523|Oral administration, once daily
16004141|NCT02857985|Device|3D RA|3D RA is realised just after angioplasty.
16004142|NCT02857985|Device|MRI|MRI is realised between 24h and 96h post angioplasty.
16004143|NCT02857972|Device|Wondaleaf®|Use of Wondaleaf® during menstruation every night in one menstrual cycle.
16004144|NCT02857959|Drug|Benzathine Penicillin G|
16004145|NCT02857946|Drug|Prevaglip (linagliptin)|1 tablet contains 5 mg linagliptin
16004146|NCT02857946|Drug|Trajenta (linagliptin)|1 tablet contains 5 mg linagliptin
16004147|NCT02857933|Other|Physical Therapy|One-on-one physical therapy sessions (one therapist and one patient). Principles of motor learning used include repetition, task-specificity, active practice, generalization of skills, errors, structured practice, and developmentally appropriate feedback with sufficient time to practice.
16004148|NCT02857920|Drug|Bevacizumab|7.5 mg/kg, i.v, once every 3 weeks (continuous)
16004149|NCT02857920|Biological|NK immunotherapy|Each treatment: 8~10 billion cells in all, transfusion in 3 times, i.v.
16004150|NCT02857907|Other|Blood sample|A blood sample is performed one year after kidney transplantation.
16004151|NCT02857881|Procedure|De-epithelization and therapeutic photokeratectomy|
16004152|NCT02857868|Drug|ABL001|
16004153|NCT02857855|Procedure|80% fraction of inspired oxygen for 6 postoperative hours|80% fraction of inspired oxygen delivered for 6 postoperative hours, either by a nonrebreathing facemask with a reservoir or by a respirator
16004154|NCT02857855|Procedure|28% fraction of inspired oxygen for 6 postoperative hours|28% fraction of inspired oxygen delivered for 6 postoperative hours, either by a Venturi facemask or by a respirator
16004155|NCT02857842|Drug|Prednisolone|
16004156|NCT02857829|Dietary Supplement|CAF+|CAF+ will be a blend consisting of caffeine (100 mg), L-theanine (200 mg), vinpocetine (40 mg), L-tyrosine (300 mg), pyridoxine (1 mg), and cobalamin (20 mg).
16004157|NCT02857829|Dietary Supplement|Caffeine-alone|Caffeine (100 mg)
16004158|NCT02857829|Other|Placebo|Rice flour
16004159|NCT02857816|Device|NURO System PTNM Therapy|
16004160|NCT02857803|Procedure|Virtual Reality|Intervention of 30 minutes, 3 times a week until reaching 12 sessions.
16004161|NCT02857803|Procedure|Paper and Pencil|Intervention of 30 minutes, 3 times a week until reaching 12 sessions.
16004162|NCT02857803|Procedure|Conventional Therapy|Intervention of 30 minutes, 3 times a week until reaching 12 sessions.
16004163|NCT02857777|Drug|Esketamine|Subjects will self-administer intranasal esketamine as per the treatment regimen.
16004164|NCT02857751|Behavioral|Surf therapy|The NMCSD surf therapy program is approximately 6 weeks in duration. Each surf therapy session lasts 2-3 hours and occurs in a group setting that can accommodate up to 20 service members per session. Each service member is paired with a surf instructor who works with him or her each week for the 6-week session. Goals are individually-tailored to the service member (based on participant's level of comfort in the water, experience with surfing, etc.) and can incorporate both physical and psychological objectives.
16004165|NCT02857738|Drug|BAY 987519|Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.
16004166|NCT02857738|Drug|SPF 15 Control|Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.
16004167|NCT02857725|Drug|BAY 987517|Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.
16004168|NCT02857725|Drug|SPF 15 Control|Single dose application of two (2) mg/cm² of test product. Each 50 cm² test site area requires 100 mg of a product to obtain a standard 2 mg/cm² test application.
16004169|NCT02857712|Drug|Axitinib|Axitinib will be self orally administered at 5 mg twice daily approximately every 12 hours, on a continuous basis (each morning and evening), in 4 week cycles until tumour progression, unacceptable toxicity or other criteria for discontinuation is met. Patients who tolerate axitinib with no adverse events axitinib-related should have a dose increased until to 10 mg twice.
16004170|NCT02857686|Procedure|intravenous regional anaesthesia|tourniquet over the arm and intravenous lidocaine with a dose of 4 mg/kg
16004171|NCT02857686|Procedure|forearm IVRA|tourniquet over the forearm and lidocaine with a dose of 1.5 mg/ kg
16004172|NCT02857673|Behavioral|Child Abuse Prevention Problem Solving|The CAPPS intervention includes problem solving, motivational interviewing, and referral to existing services. Intervention providers will conduct three core problem solving sessions and three sessions tailored to the common problems experienced by parents of CSHCN: caregiver burden, difficulties navigating complex medical services, and social isolation. Intervention providers will use their motivational interviewing skills during regular, ongoing interactions with their clients to enhance willingness to participate meaningfully in CAPPS sessions. Referral to existing services in the medical home and in the community will occur as needs arise during CAPPS sessions.
16004173|NCT02857673|Behavioral|Active Control Group|Parents in both study groups will receive the standard medical and social work services offered in the patient-centered medical homes where their children receive care. In addition, to account for potential surveillance bias, families in the control group will be contacted by a member of the study team six times over 12 weeks, approximating the frequency of contact that the intervention group receives from the CAPPS providers.
16004174|NCT02857660|Other|Whole body Electromyostimulation (exercise)|1.5 x 20 min/week (e.g. each Tuesday and every second Friday) with bipolar current, 85 Hz, 360 µs, rectangular mode, intermittent with 4 sec of current and 4 s of rest.
16004175|NCT02857660|Dietary Supplement|Protein|up to 1.5-1.7 g/kg bodymass/d of protein (whey protein)
16004176|NCT02857647|Behavioral|An information video|Participants who will assigned to the experimental group will be asked to watch a 30 minutes videotaped lecture 1-2 weeks prior to the surgery date. Topics includes: types of surgeries, preparation to the hospitalization process and to the surgery (e.g. what to expect, personal equipment needs, description of the surgery admission process, etc.), dietary guidelines pre- and post-surgery (e.g. low carb diet 2-3 week prior to the surgery, post-surgery diet progression, techniques of eating and drinking, recommended dietary supplements), recommendation and tips for long term surgery success (e.g. definition of weight loss expectations, physiological, nutritional and life-style strategies for long-term weight loss).
16004224|NCT02857309|Device|OPTIMIZER|The OPTIMIZER System delivers non-excitatory cardiac contractility modulation (CCM) signals to the heart that are intended to influence myocardial properties in patients with chronic heart failure. The system has no pacemaker or implantable cardioverter-defibrillator (ICD) functions.
16004225|NCT02857309|Drug|Optimal medical therapy|OMT using standard heart failure (HF) drugs
16004226|NCT02857296|Other|interview and observation|
16004959|NCT02851121|Other|Experimental protocols|
16071137|NCT02374567|Drug|Diphenhydramine|
16004177|NCT02857634|Device|Cellvizio dual band|Using fluorescence cytoscopy, lesions in the bladder will be resected. The samples will be immediately observed in order to keep the fluorescein effect under confocal microscopy (Cellvizio dual band). After confocal microscopy samples will be fixed in formalin and prepare for the pathologist that will confirm the diagnosis. The Cellvizio system can be used to observe a resected sample ex vivo, offering a cellular-level view of internal tissue. This technique allows the visualization of the microstructure of the tissue in real-time which may improve targeted sampling, provide earlier disease detection and help patient management. The Cellvizio system includes miniaturized optics, optical fiber bundles, high-speed scanning and advanced image processing components.
16004178|NCT02857608|Drug|Lymphoseek|
16004179|NCT02857595|Behavioral|Online Behavioral Weight Loss program|
16004180|NCT02857595|Behavioral|Weight Loss Nomogram|
16004181|NCT02857595|Behavioral|Bite Counter|
16004182|NCT02857582|Biological|Cultured human intestinal microbiota|Secondary treatment for C diff in replacement for regular vancomycin.
16004183|NCT02857582|Drug|Vancomycin|Active comparator to treatment with ACHIM
16004184|NCT02857582|Drug|Metronidazole|Primary treatment for C diff in all treatment arms
16004185|NCT02857569|Drug|Ipilimumab IT|
16004186|NCT02857569|Drug|Ipilimumab IV|
16004187|NCT02857569|Drug|Nivolumab IV|
16004188|NCT02857556|Biological|Blood sample|
16004189|NCT02857556|Other|Retinal photography:|
16004190|NCT02857556|Other|dialyse|
16004191|NCT02857543|Other|Plant-Based Diet|
16004192|NCT02857543|Other|American Heart Association Diet|
16004193|NCT02857543|Other|Mediterranean Diet|
16004194|NCT02857530|Drug|rhTPO|rhTPO
16004195|NCT02857530|Drug|placebo|without rhTPO
16004196|NCT02857517|Drug|conbercept|0.05ml conbercept
16004197|NCT02857504|Device|double lumen tube with a hook|The tube with the hook (after passing the bronchial cuff trough the vocal cords) was rotated for 180 degrees to the left and removed the stylet and when the hook passed the vocal cords, the tube was rotated for 90 degrees back to the right and push it into the bronchus. Following formula was used for the right depth (height (cm)/10 + 12 (cm)) of the tube without the hook. The tube with hook was inserted into the bronchus so that hook was placed on the carina and stopped.
16004198|NCT02857504|Device|double lumen tube without a hook|Tube without the hook was inserted with the following technique: after the bronchial cuff was passed the vocal cords, the stylet was removed and the tube was rotated 90 st towards left.
16004199|NCT02857491|Drug|ranibizumab|intravitreal injection of 0.5 mg ranibizumab before vitrectomy
16004200|NCT02857491|Drug|sham|sham intravitreal injection before vitrectomy
16004201|NCT02857491|Procedure|pars plana vitrectomy|surgical procedure to remove the intravitreal hemorrhage and fibrosis membrane, and re-attach the retina, and perform endo laser photocoagulation on retina.
16004202|NCT02857478|Drug|BAY 987519, SPF 50, Y51-002|Sufficient amount to cover all exposed skin liberally two times - approximately 240 min.
16004203|NCT02857478|Drug|BAY 987519, SPF 50, P04-147|Sufficient amount to cover all exposed skin liberally two times - approximately 240 min.
16004204|NCT02857465|Drug|Dexamethasone|single epidural injection of dexamethasone (8 mg) in addition to local anesthetics used for epidural analgesia
16004205|NCT02857465|Drug|Placebo|single epidural injection of sodium chloride 0.9% (2 mL) in addition to local anesthetics used for epidural analgesia
16004206|NCT02857465|Drug|Ropivacaine|NAROPEINE 7.5 mg/mL is diluted at the concentration of 1 mg/mL prior to the epidural use. The perfused dose depends on the efficacy of analgesia in reducing the delivery labor pain.
16004207|NCT02857465|Drug|Sufentanil|Sufentanil 0.5 mg/L is used as solution for injection for epidural analgesia and used in combination with ropivacaine. The administered dose is bolus of 15 to 20 micrograms diluted into 10 mL.
16004208|NCT02857452|Other|SLA Questionnaire|
16004209|NCT02857452|Other|Lupus Qol Questionnaire|
16004210|NCT02857439|Other|Standard diagnostic item list|All consecutive patients are assessed by both examiners, according to a standardized physical examination item list.
16004211|NCT02857426|Drug|Nivolumab|
16004212|NCT02857400|Other|current standard of care|connection documentation faxed to GP (General practitioner) on the day of patient's discharge
16004213|NCT02857400|Other|CREDO standard of care|"organized consultation return home between patient, GP DESC (diploma of complementary specialized study) and patient's referent GP"
16004214|NCT02857387|Biological|blood sample withdrawn|
16004215|NCT02857374|Procedure|Diagnostic Microscopy|Undergo intravital microscopy
16004216|NCT02857374|Drug|Fluorescein Sodium Injection|Given IV
16004217|NCT02857374|Other|Laboratory Biomarker Analysis|Correlative studies
16004218|NCT02857374|Procedure|Sentinel Lymph Node Biopsy|Undergo standard of care sentinel node biopsy
16004219|NCT02857361|Drug|Sublingual ketamine wafers|Two sublingual ketamine 25 mg wafers
16004220|NCT02857348|Behavioral|Night Shift|Night Shift is an adventure video game with the transformational goal of teaching physicians key characteristics of patients with non-representative severe injuries - injuries classified by the American College of Surgeons as life-threatening or critical but that do not fit the archetype of injuries typically requiring treatment at a trauma center. Players take on the persona of Andy Jordan, a young emergency physician who moves home after the disappearance of his estranged grandfather (Robert Jordan) and takes up a job in the local Emergency Department (ED). In the preamble, players learn they have two explicit objectives. First, they must diagnose and treat patients who present to their ED. Second they must solve the mystery of Robert's disappearance: was he murdered or has he simply chosen to disappear?
16004221|NCT02857348|Behavioral|Educational Module|The educational module consists of two separate apps, both commercially available. myATLS includes a review of each chapter of the Advanced Trauma Life Support (ATLS) textbook, a series of videos demonstrating common trauma procedures, and clinical resources including checklists for use at the bedside. Trauma Life Support MCQ Review includes 550 multiple-choice questions with correct answers and explanations. The investigators will ask physicians to review the myATLS app and then complete questions in the Trauma Life Support MCQ Review, spending at least 1 hour on the combined tasks.
16004222|NCT02857335|Behavioral|neurocognitive tests|Subjects will undergoe a battery of neurocognitive testing which will test memory, flexible thought process, problem, attention span
16004227|NCT02857283|Other|Ozone|Participants will be exposed to a concentration of ozone for 6.5 hours at a concentration that varies 0.06 to 0.08
16004228|NCT02857283|Other|Filtered Air|Participants will be exposed to filtered clean air
16004229|NCT02857283|Device|Health and Exposure Tracker (HET)|Ozone and heart rate tracker
16004230|NCT02857270|Drug|LY3214996|Administered orally
16004231|NCT02857270|Drug|Midazolam|Administered orally
16004232|NCT02857270|Drug|Abemaciclib|Administered orally
16004233|NCT02857270|Drug|Nab-paclitaxel|Administered IV
16004234|NCT02857270|Drug|Gemcitabine|Administered IV
16004235|NCT02857270|Drug|Encorafenib|Administered orally
16004236|NCT02857270|Drug|Cetuximab|Administered IV
16004237|NCT02857257|Biological|ACHIM|After an observation period of 4 weeks patients with IBS-D will be treated with ACHIM
16004238|NCT02857244|Drug|Duloxetine|Patients will first receive Duloxetine for 4 weeks starting at 30mg, 60mg, 90mg then 120mg (if tolerated). Increases in dosage amounts will occur every week.
16004239|NCT02857244|Drug|Donepezil|Patients will receive Donepezil after 4 weeks of dosing with Duloxetine. Patients will receive Donepezil in combination with the highest dose of Duloxetine that was tolerated. Patients will remain on this for 2 weeks with increasing doses at each week. One week of 5mg, one week of 10mg.
16004240|NCT02857244|Drug|Modafinil|Patients will receive Modafinil after a 4 week washout period (after dosing with donepezil & duloxetine in combination). Patients will receive Modafinil for two weeks with increasing doses at each week. One week at 100mg, one week at 200mg.
16004241|NCT02857218|Drug|Ferumoxytol|Undergo ferumoxytol-enhanced MRI
16004242|NCT02857218|Procedure|Magnetic Resonance Imaging|Undergo ferumoxytol-enhanced MRI
16004243|NCT02857205|Other|Fecal samples|High throughput sequencing methods and analysis for microbiome analysis on fecal samples from a multicenter cohort of patients at various ages.
16004244|NCT02857192|Biological|Blood samples|
16004245|NCT02857179|Procedure|bariatric surgery|gastric bypass Or gastric banding Or Biliopancreatic diversion with duodenal switch Or sleeve gastrectomy Or endoscopic procedure (Endobarrier,…)
16004246|NCT02857166|Biological|humanized anti-PD-1 monoclonal antibody toripalimab|humanized anti-PD-1 monoclonal antibody (JS001) is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically.
16004247|NCT02857153|Drug|Urapidil|If necessary, intravenous urapidil 0.2-0.5 mg/kg when mean arterial pressure exceeded 10 mmHg of the target value, rather than more anesthesia, may be used in situations wherein sympathetic stimulation was high; yet a sufficient amount of anesthesia was being administered and bispectral index showed an adequate depth of hypnosis. Sedation was provided by a propofol infusion targeted to a BIS number of approximately 50 during general anesthesia.
16004248|NCT02857153|Drug|Phenylephrine|If necessary, intravenous phenylephrine 4-6 μg/kg when mean arterial pressure exceeded 10 mmHg of the target value, rather than more anesthesia, may be used in situations wherein sympathetic stimulation was high; yet a sufficient amount of anesthesia was being administered and bispectral index showed an adequate depth of hypnosis. Sedation was provided by a propofol infusion targeted to a BIS number of approximately 50 during general anesthesia.
16004249|NCT02857153|Procedure|Low-level MAP|MAP is regulated to the goal level (60-70 mmHg) during general anesthesia.
16004250|NCT02857153|Procedure|High-level MAP|MAP is regulated to the goal level (90-100 mmHg) during general anesthesia.
16004251|NCT02857127|Behavioral|Walking program|To encourage people to exercise more through a behavioural and educational intervention during six months and other six months of follow up.
16004252|NCT02857114|Other|massage|
16004253|NCT02857101|Other|dosage of calprotectin|
16004254|NCT02857088|Behavioral|olfactory assessment|determination of olfactory sensitivity through olfactory threshold assessment (butanol) determination of hedonicity and intensity of 16 usual odors
16004255|NCT02857088|Behavioral|image visualization|20 images (from the IAPS-international affective picture systems) are presented to the subject. He has to determine the hedonicity of each picture.
16004256|NCT02857088|Behavioral|psychophysiological assessment|during the olfaction assessment and the image visualization, skin conductance reactivity (SCR) is recorded to assess unconscious emotional reactivity
16004257|NCT02857075|Other|Blood donation|Red cell concentrates derived from healthy blood donating people. In France, all blood donation is realized by the Etablissement Français du Sang, so all the study samples are from this center.
16004258|NCT02857062|Device|E45 Eczema Repair Emollient|E45 Eczema Repair Emollient
16004259|NCT02857049|Other|Oral nutritional supplements (ONS) degustation|
16004260|NCT02857036|Other|rhythmic parameter recording|the following rhythmic parameters are recording during 48 hours: temperature, heart rate and actimetry
16004261|NCT02857036|Behavioral|psychiatric assessment|different psychometric scales are filled in: Montgomery and Asberg depression rating scale (MADRS), Quick inventory depression scale (QIDS-C16) and Beck depression inventory (BDI)
16004262|NCT02857023|Behavioral|Cogmed RM|Cogmed consists of 12 increasingly challenging exercises (completed over 25 sessions spanning 5-8 weeks) that target skills involving visuo-spatial and verbal working memory.
16004263|NCT02857010|Biological|Allogenic mesenchymal stem cells|Cell therapy
16004264|NCT02857010|Other|Placebo|Serum without stem cells
16004265|NCT02856997|Drug|Chidamide with ICE regimen|Chidamide and ICE regimen, dosage described in arm description
16004266|NCT02856958|Procedure|Nerve decompression|
16004267|NCT02856958|Other|Non-operative|Physical therapy
16004268|NCT02856932|Other|Conventional high viscosity glass ionomer|Dental restorative material
16004269|NCT02856932|Other|Glass ionomer with glass hybrid technology|Dental restorative material
16004270|NCT02856919|Drug|brimonidine tartrate|Mirvaso® gel (5 mg/g brimonidine tartrate)
16004271|NCT02856906|Other|occlusal adjustment|
16004272|NCT02856893|Drug|Osimertinib|Osimertinib 60 or 40 mg daily until progression
16004273|NCT02856893|Drug|Gefitinib|Gefitinib 250mg daily until progression
16004274|NCT02856880|Other|Test zinc-IPMP toothpaste|Test toothpaste containing 0.6% w/w zinc chloride and 0.1% w/w IPMP and 1426ppm fluoride as sodium fluoride.
16071138|NCT02374567|Drug|Promethazine|
16004275|NCT02856880|Other|Test zinc non- IPMP toothpaste|Test toothpaste containing 0.6% w/w zinc chloride, 0% w/w IPMP and 1426ppm fluoride as sodium fluoride.
16004276|NCT02856880|Other|Positive control|Positive control toothpaste containing 0.454% w/w stannous fluoride (Fluoride Toothpaste (1100ppm Fluoride as stannous fluoride)).
16004277|NCT02856880|Other|SLS negative control|Negative control toothpaste containing 2.0% SLS, 0.65% Tegobetain and 1150 ppm fluoride as sodium fluoride
16004278|NCT02856880|Other|non-SLS negative control|Negative control toothpaste containing 1426 ppm fluoride as sodium fluoride
16004279|NCT02856867|Drug|Nintedanib|
16004280|NCT02856867|Drug|Fluorouracil|
16004281|NCT02856867|Drug|Leucovorin|
16004282|NCT02856867|Drug|Oxaliplatin|
16004283|NCT02856867|Drug|Placebo|
16004284|NCT02856854|Drug|EMB-001|EMB-001 is a combination of metyrapone (720mg per dose in this study) and oxazepam (24mg per dose in this study)
16004285|NCT02856854|Drug|Placebo|EMB-001 matched placebo
16004286|NCT02856854|Drug|Cocaine IV|Cocaine administered at doses of 20 and 40mg
16004287|NCT02856854|Drug|Saline IV|Cocaine matched placebo
16004288|NCT02856828|Device|DIE|digital image enhancement
16004289|NCT02856815|Biological|Immuncell-LC|Activated T lymphocyte : intravenous dripping of 200ml (1 x 10^9 ~ 2 x 10^10 lymphocytes / 60kg adult) for 1 hour
16004290|NCT02856802|Drug|Sumatriptan 10 mg Nasal Spray|100 μL nasal spray once
16004291|NCT02856802|Other|Sumatriptan Placebo Nasal Spray|100 μL nasal spray once
16004292|NCT02856789|Other|Routine hemostasis tests|Prothrombin Time (PT),Thrombin Time (TT), Activated Partial Thromboplastin Time (APTT), Fibrinogen, D-Dimers
16004293|NCT02856789|Other|Fibrin structure (FS)|FS will be determined on STA-R® prototype at Percy and at Stago
16004294|NCT02856789|Other|Thromboelastography (TEG)|Thromboelastography will be processed on TEG® at Percy
16004295|NCT02856789|Other|Specialized hemostasis tests|Coagulation factors
16004296|NCT02856776|Dietary Supplement|Vitamin D3|Vitamin D provided in capsule form
16004297|NCT02856750|Drug|Gabapentin|Gabapentin 300 mg three times daily x30 days
16004298|NCT02856737|Other|eye masks and earplugs|Materials similar to those offered on long commercial flights
16004299|NCT02856724|Drug|PGE2|10 mg PGE2 vaginal ovul(Propess)
16004300|NCT02856711|Behavioral|Trauma-informed group|"The two interventions will be: 1) A viewing of All Babies Cry and a discussion of what it's like to be a new parent, 2) A Planning to Parent stress activity where parents discuss when they have felt overwhelmed, the coping mechanisms they used, and what can be done to manage those emotions in the future. The goal of this project is to gain insight from current participants in CenteringPregnancy group care around the ways that these interventions can better prepare parents to deal with the common stresses of parenthood."
16004301|NCT02856698|Drug|Midazolam|Dose use according to the product technical sheet
16004302|NCT02856698|Drug|Morphine|Dose use according to the product technical sheet
16004303|NCT02856685|Drug|Mitoxantrone Hydrochloride Liposome|Mitoxantrone Hydrochloride Liposome will be administered via IV infusion over 60 minutes once at the beginning (Day 1) of each 28-day cycle
16004304|NCT02856672|Device|Supreme Laryngeal Mask Airway|Supreme Laryngeal Mask Airway
16004305|NCT02856672|Device|Laryngeal Tube Suction Disposable|Laryngeal Tube Suction Disposable
16004306|NCT02856633|Device|Vitaliti|
16004307|NCT02856620|Other|Observational only|Observational only
16004308|NCT02856607|Other|determine the prognosis of threated patients according to the clinical care pathway.|
16004309|NCT02856594|Drug|Dexmedetomidine|Dexmedetomidine
16004310|NCT02856594|Drug|Placebo|Placebo
16004311|NCT02856581|Drug|Varenicline|Given PO
16004312|NCT02856581|Drug|Placebo|Given PO
16004313|NCT02856581|Other|Tobacco Cessation Counseling|Complete counseling session
16004314|NCT02856568|Drug|Cisplatin|Given IV
16004315|NCT02856568|Drug|Gemcitabine Hydrochloride|Given IV
16004316|NCT02856568|Other|Laboratory Biomarker Analysis|Correlative studies
16004317|NCT02856568|Other|Pharmacological Study|Correlative studies
16004318|NCT02856568|Drug|Ricolinostat|Given PO
16004319|NCT02856555|Drug|Firsocostat|Capsules orally once daily.
16004320|NCT02856555|Drug|Placebo|Placebo matched to firsocostat orally once daily.
16004321|NCT02856542|Drug|calcipotriol/betamethasone dipropionate gel in Applicator|Topical treatment of scalp using applicator device. The study as such is non-interventional as the intervention has been decided prior to and independently from the inclusion of the patient in the cohort to be observed.
16004322|NCT02856529|Other|Training|The Basic Infection Control Skills License program (BICSL) includes meningitis and influenza vaccination as well as fit test to verify the correctly fitting of the respirator. Also, the license program includes training on hand hygiene and the use of personal protective equipment (PPE). To get the license, each participants must get the vaccination and attend one to one training session with a program trainer 34.
16004323|NCT02856529|Other|General session|A general session about the basic of infection control was conducted for this group. The lecture performed in the same way of the regular training fulfill.
16004324|NCT02856516|Other|Boost Glucose Control (A)|Oral nutrition supplement
16004325|NCT02856516|Other|Boost Glucose Control (B)|Oral nutrition supplement
16004326|NCT02856516|Other|Boost Original|Oral nutrition supplement
16004327|NCT02856503|Drug|Vitamin D3|Weekly oral dose of Vitamin D3 per protocol.
16004328|NCT02856477|Biological|urine analysis|a sample of urine is collected during 8 hours.
16004329|NCT02856464|Other|DLI will be administered to all patients at Month 4 (+/- 20 days) after stem cell transplant regardless of peripheral blood CD3 chimerism (including if they have full donor chimerism)|
16004330|NCT02856464|Other|DLI will be administered from Month 6 (+/- 20 days) after stem cell transplant according to institutional practice|
16004331|NCT02856451|Biological|Nivolumab|Specified dose on specified days
16004332|NCT02856438|Drug|Elotuzumab|Specified dose on specified days
16004333|NCT02856438|Drug|Lenalidomide|Specified dose on specified days
16004334|NCT02856438|Drug|Dexamethasone|Specified dose on specified days
16004498|NCT02855073|Biological|ReJoinTM|adipose derived mesenchymal progeinitor cells
16004335|NCT02856425|Drug|Nintedanib|Nintedanib oral tablets. An angiokinase inhibitor targeting VEGFR 1-3, FGFR 1-3, and PDGFR α/β as well as RET. Refer to current IB for product details
16004336|NCT02856425|Drug|Pembrolizumab|Pembrolizumab, Intravenous. An IgG4 anti-PD-1 blocking monoclonal antibody. Refer to current IB for product details
16004339|NCT02856386|Dietary Supplement|polyphenol supplement|8 mL once daily
16004340|NCT02856373|Procedure|RNS and RDN|The patients will undergo electrical renal nerve stimulation and subsequently renal nerve denervation
16004341|NCT02856360|Other|Moderate Stiffness Footwear|Standard moderately stiff footwear for typical high school football players will be randomly allocated to each group
16004342|NCT02856360|Other|High Stiffness Footwear|Standard highly stiff footwear for typical high school football players will be randomly allocated to each group
16004343|NCT02856347|Other|18F-DOPA|Injection of 18F-DOPA and PET / CT-scan assessment
16004344|NCT02856308|Device|Hairstetics hair implant device|
16004345|NCT02856295|Drug|clexane (LMWH)|to compare tow doses of clexane for preventing VTE in postpartum women
16004346|NCT02856282|Drug|Pirinase Hayfever Relief for Adults 0.05% Nasal Spray|Aqueous suspension of 0.05% micronised fluticasone propionate.Each actuation contains 50 micrograms of fluticasone propionate
16004347|NCT02856269|Dietary Supplement|Zinc gluconate|Participants will take a daily dose of zinc gluconate.
16004348|NCT02856256|Dietary Supplement|RedBull® energy drink|Subjects consume 25 mL of RedBull® energy drink
16004349|NCT02856243|Drug|new antiviral therapy|
16004350|NCT02856230|Device|Ranger SL DEB|BTK angioplasty using Ranger SL DEB
16004351|NCT02856217|Procedure|tunneling|In this arm of the study which is Peritoneal tunneling group in SCP, standard minimal invasive sacrocolpopexy procedure will be performed. Placement of mesh between vaginal apex and sacrum is retroperitoneally (creating a tunnel between vaginal apex and sacrum under peritoneum without disturbing the integrity of the peritoneum)
16004352|NCT02856217|Procedure|non-tunneling|In this arm of the study which is Peritoneal non-tunneling group in SCP, standard minimal invasive sacrocolpopexy procedure will be performed. Placement of mesh between vaginal apex and sacrum is retroperitoneally (incised and sutured peritoneum between vaginal apex and sacrum).
16004353|NCT02856204|Other|Cytology Specimen Collection Procedure|Undergo collection of blood
16004354|NCT02856204|Other|Laboratory Biomarker Analysis|Correlative studies
16004355|NCT02856191|Other|Holter|
16004356|NCT02856178|Drug|F901318|F901318 treatment starting after completion of chemotherapy. Max. 14 days of intravenous F901318 b.i.d. treatment, followed by one oral dose of F901318. Loading doses 4 mg/kg b.i.d. , maintenance doses 2 mg/kg b.i.d.
16004357|NCT02856178|Drug|Caspofungin|Intravenous Caspofungin treatment starting during chemotherapy for concomitant prophylaxis of fungal infection. Loading dose 70 mg q.d., maintenance doses 50 mg q.d.
16004358|NCT02856165|Device|High-flow nasal canula oxygen therapy|High-flow nasal canula oxygen therapy (HNF) using Optiflow junior system and AIRVO2 turbine (F&P, NZ) at initial flow to 3l/kg/min (up to a maximum of 20l/min), FiO2 adjusted for SpO2 > 94%.
16004359|NCT02856165|Device|Low-flow oxygen therapy with standard nasal canula|flow adjusted to SpO2 > 94% (up to a maximum of 2l/min).
16004360|NCT02856152|Drug|GDC-0276 capsule|Three 90 milligram [mg] capsules of GDC-0276 administered orally.
16004361|NCT02856152|Drug|GDC-0276 tablets|Three 90 mg GDC-0276 tablets administered orally.
16004362|NCT02856126|Procedure|Hepatic arterial infusion chemotherapy|
16004363|NCT02856126|Procedure|Transarterial chemoembolization|
16004364|NCT02856126|Drug|TACE regimen|infusion with lipiodol mixed with chemotherapy drugs (EADM , lobaplatin, and MMC ), and embolization with polyvinyl alcohol particles (PVA)
16004365|NCT02856126|Drug|HAIC Regimen|Hepatic intra-arterial infusion via the tumor feeding arteries of Oxaliplatin , fluorouracil, and leucovorin
16004366|NCT02856126|Drug|Oral Sorafenib|Oral Sorafenib, 400mg, Bid
16004367|NCT02856113|Drug|Alogliptin Benzoate|Alogliptin benzoate tablets.
16004368|NCT02856113|Drug|Placebo|Alogliptin placebo-matching tablets.
16004369|NCT02856100|Drug|18F DCFPyL- Radiopharmaceutical|
16004370|NCT02856087|Drug|High dose Remifentanil|remifentanil infusion at 4ng/ml of Ce
16004371|NCT02856087|Drug|Naloxone|naloxone infusion
16004372|NCT02856087|Drug|Low dose remifentanil|remifentanil infusion at 1ng/ml of Ce
16004373|NCT02856087|Drug|Normal Saline|normal saline infusion
16004374|NCT02856074|Biological|prise de sang|
16004375|NCT02856074|Other|quality of life questionnaire|
16004376|NCT02856061|Behavioral|Pivotal Response Treatment|Pivotal response treatment (PRT) is an empirically validated behavioral treatment for individuals with ASD that has its foundation in principles of Applied Behavioral Analysis. It was designed to improve social communication skills by addressing core deficits in social motivation or pivotal responses. By working specifically with each child's natural motivations, PRT focuses on naturalistic, functional skills, as opposed to rote skills. In this study, participants randomized to the PRT group will receive 6 hours of direct PRT, across three sessions per week, provided by Dr. Ventola's clinical team. Parents will have an additional one-hour session per week focused on PRT parent training using a practice-with-feedback model. Specific intervention goals in our target population include: Speech to respond to inquiries, Speech to inquire, Speech to comment, Reciprocal conversation, Monitor nonverbal information, and Perspective taking.
16004377|NCT02856048|Drug|Triptorelin (GnRHa) + Chemotherapy|During her chemotherapy, the patient in the experimental arm will have regular injections of Triptorelin (DECAPEPTYL LP 3 mg, IPSEN) in order to preserve her fertility
16004499|NCT02855073|Drug|Sodium Hyaluronate|Sodium Hyaluronate Injection
16004378|NCT02856035|Other|Neural feedback plus FES and motor training|We are not testing the feasibility of the imaging methods; that has been well established and is used clinically. We are testing the feasibility of using neural feedback clinical imaging methods in a neural feedback paradigm which involves sequential rtfMRI (phase I) and rtfNIRS (phase II) training; Neurally-triggered, peripherally-directed FES-assist practice of wrist and finger extension will be combined with rtfNIRS training in Phase II; up to 60 total sessions, including additional motor learning sessions without brain neural feedback will be provided in Phase III.
16004379|NCT02856022|Device|Electrical ilioinguinal nerve stimulation|"Four abdominal points are selected. The upper two points are located 2.5 cun bilateral to Guanyuan (Ren 4). The lower two points are located 1.5 cun bilateral to Zhongji (Ren 3). Four long needles are punctured obliquely 1~2 cun in depth (depending on the fat layer thickness of the patient) to the four points to make the needling sensation reaching the urethra or vulva.
~After the needling sensation reach the above regions, each of two pairs of electrodes from a device are connected with the two ipsilaterally inserted needles. The parameters are continuous waves, a frequency of 2.5 Hz and intensity that the patient feels comfortable for 60 min, three times a week for at least four weeks."
16004380|NCT02856022|Procedure|Intravesical Irrigation|The patient was asked to lie on a couch in a lithotomy position after urination. A catheter was passed through the urethra into the bladder and any residual urine drained. The Cystistat 50mL 40mg (sodium hyaluronate, Bioniche Teoranta, Ireland) solution is instilled through the catheter into the bladder. The catheter is then withdrawn leaving the Cystistat inside the bladder coating the lining. It was recommended the solution was retained for as long as possible, ideally at least 30 minutes. The instillation is once weekly for at least four weeks.
16004381|NCT02856009|Other|completion of a quality of life questionnaire|
16004382|NCT02855996|Other|Fathers in Action/Padres Activos (FA/PA) program|The program focuses on increasing the father's role in the child's education, nurturing and bonding with the child, loving and respecting the child's mother, coaching the child, and serving as a role model. The program also includes employment coaching.
16004383|NCT02855983|Procedure|Fat Grafting|Grafting of autologous fat tissue is a minimally invasive surgical technique that starts with the harvest of fat tissue from the abdomen or thighs using liposuction through incisions less than 2mm in length. The lipoaspirate is then processed to concentrate the adipose fraction and reinjected into the graft site. This surgical procedure involves the immediate transplantation of a patient's own tissue in a single operative procedure.
16004384|NCT02855970|Other|completion of a quality of life questionnaire|
16004385|NCT02855957|Other|Free α-Hb pool analysis|
16004386|NCT02855944|Drug|Chemotherapy|Chemotherapy will be administered per local standard of care and regulations. Specific comparator will depend on platinum status and investigator decision.
16004387|NCT02855944|Drug|Rucaparib|Tablets of rucaparib, at a dose of 600 mg, will be taken orally twice daily
16004388|NCT02855931|Procedure|Middle turbinate resection|
16004389|NCT02855918|Other|Blood sample for genetic purpose|"All the participants will performed the same evaluations and blood analysis :
~A clinical assessment by psychiatrist
~Self report questionnaires for the assessment of a potential mood disorder and history of SB, moral/physical pain, personality traits…
~A neuropsychological assessment for the evaluations of cognitive performances
~A routine blood sampling to the realization of a standard blood test
~A specific blood sampling (PAXgene® tubes) to extract total RNA of blood cells and measure the expression of ADARS RNA and editing of the PDE8A transcript."
16004390|NCT02855905|Other|Exercise/Rest and cold/neutral temperature|Subjects were either exercising or resting in either cold or neutral environmental temperature
16004391|NCT02855892|Other|Placebo|
16004392|NCT02855892|Drug|GV1001|
16004393|NCT02855879|Other|Collection of biological data|
16004394|NCT02855879|Other|Collection of clinical data|
16004395|NCT02855866|Procedure|thyroidectomy|
16004396|NCT02855866|Other|cryotherapy|
16004397|NCT02855866|Drug|cortisone aerosol|
16004398|NCT02855866|Drug|Dexamethasone acetate|
16004399|NCT02855866|Drug|paracetamol|
16004400|NCT02855853|Other|serious game et virtual reality|
16004401|NCT02855853|Other|Nintendo Wii|
16004402|NCT02855840|Other|completion of the quality of life questionnaire|
16004403|NCT02855814|Other|Body Composition|No intervention. This is an observational, normative study of body composition variation in preterm infants
16004404|NCT02855801|Other|constant exercise|
16004405|NCT02855801|Other|cryotherapy|
16004406|NCT02855801|Other|intermittent exercise|
16004407|NCT02855788|Drug|Paclitaxel 60mg/m2, Oxaliplatin 50mg/m2, Leucovorin 20mg/m2, and 5-FU 425mg/m2 IV weekly|metronomic chemotherapy
16004408|NCT02855775|Other|additional blood sample|blood sample every 3 weeks
16004409|NCT02855762|Other|High polyunsaturated fatty acid diet.|The investigators hypothesize the diet will improve gut health and psychiatric clinical outcomes.
16004410|NCT02855749|Procedure|ultrasound-guided percutaneous tracheostomy|to compare the reliability of the traditional landmark method, ultrasound-guided long axis in plane applications and ultrasound-guided short-axis out of plane application in the implementation process percutaneous tracheostomy
16004411|NCT02855736|Behavioral|Positive Psychology|"Gratitude Journal (Emmons and Stern, 2013)
~Every evening, patients have to write down the things they feel grateful about."
16004412|NCT02855736|Behavioral|Placebo (food journal)|"Food journal (i.e. alimentary list):
~Patients have to write down the list of foods eaten during the day."
16004413|NCT02855723|Other|Surgery: GS strategy|sentinel node biopsy
16004414|NCT02855723|Other|Surgery: Classic strategy|systematic lymphadenectomy
16004415|NCT02855710|Other|Rhythm workers training Perceptive timing|Perceptive timing training
16004416|NCT02855710|Other|Rhythm workers training sensorimotor timing|Sensorimotor timing training
16004417|NCT02855710|Other|No Rhythm workers training|No training
16004418|NCT02855697|Drug|Olaparib|300 mg taken twice daily, equivalent to a total daily dose of 600 mg
16004419|NCT02855697|Drug|Cediranib|20mg dose of cediranib was selected for this study
16004420|NCT02855697|Drug|Platinum-based Chemotherapy|1 or 2 two courses of platinum-based chemotherapy administered depending on trial entry point.
16004421|NCT02855684|Drug|Insulin glargine (U300)|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
16004422|NCT02855684|Drug|Insulin glargine|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
16004423|NCT02855684|Drug|Non-insulin antihyperglycemic drugs|"Pharmaceutical form: capsule/tablet
~Route of administration: oral"
16004424|NCT02855671|Device|Infrared thermal imaging|Patients in all groups will undergo infrared thermal imaging of the face and anterior leg (centered on the knee)
16004425|NCT02855658|Drug|SS-1|The patients will be divided into two groups (A and B) at random and all of them keep the routine treatment in the rheumatology OPD. Group A patients will receive 12 weeks SS-1 treatment first, and then stop the SS-1 for 4 weeks for wash-out phase, and then receive 12 weeks placebo treatment. Group B patients receive 12 weeks placebo first, and then stop the placebo treatment for 4 weeks for wash-out phase, and then receive 12 weeks SS-1 treatment. SS-1 is composed of 3 traditional Chinese herbal formula: Gan-Lu-Yin, Sang-Ju-Yin and Xuefu-Zhuyu-Decoction with the ratio of 2:1:1. The placebo is composed with corn starch, pigment and minimal dose of 1% SS-1. Patients in both groups take 6 gram of SS-1/Placebo three times per day.
16004426|NCT02855658|Drug|Placebo|The placebo is composed of corn starch, pigment and minimal dose of 1% SS-1. Patients take 6 gram of experiment medicine three times per day.
16004427|NCT02855645|Drug|Trichosanthes root|Trichosanthes root at a rate of 1.5 g two times per day for 84 days.
16004428|NCT02855645|Drug|Placebo|Trichosanthes root at a rate of 0.15g (10%) two times per day for 84 days.
16004429|NCT02855632|Drug|G-CSF|7 days after first hysteroscopic adhesiolysis, G-CSF will be injected into the uterine cavity after balloon removing.
16004430|NCT02855632|Drug|Normal saline|7 days after first hysteroscopic adhesiolysis, normal saline will be injected into the uterine cavity after balloon removing.
16004431|NCT02855632|Drug|hormone therapy|In all cases hormone therapy was commenced shortly after the operation, consisting of oestradiol valerate at a dose of 6 mg per day for 21-28 days with the addition of medroxyprogesterone acetate at a dose of 6 mg per day for the last 7-10 days of the oestrogen therapy. Following the withdrawal bleed, the hormone therapy was repeated for another cycle.
16004432|NCT02855632|Other|Cook balloon|At the end of the procedure, the Cook balloon were placed in the uterine cavity of each patient.the device was removed after 7 days.
16004433|NCT02855619|Procedure|Martin|"The physiotherapist perform the IMT using the threshold IMT inspiratory muscle trainer, connected to the intubation tube. He manage the resistance to the higher resistance tolerated by the patient in a set of 6 breaths. Participant repeats 4 sets of 6-10 breaths with 2 minutes of resting with mechanical ventilation between each set.
~This treatment is made twice a day, 7days per week from inclusion to extubation exept if Glasgow score is under 8, hyperthermia more than 39°c, haemodynamic's instability, or hypoxemia( PaO2/FiO2<150)."
16004434|NCT02855619|Procedure|Cader|"The physiotherapist perform the IMT using the threshold IMT inspiratory muscle trainer, connected to the intubation tube. He manage the resistance to 30% of the Maximal Inspiratory Pressure initially recorded the day of the inclusion. Participant breaths against this resistance during 5 minutes. The resistance is daily increased of 10 % to the higher tolerated.
~This treatment is made twice a day, 7days per week from inclusion to extubation exept if Glasgow score is under 8, hyperthermia more than 39°c, haemodynamic's instability, or hypoxemia( PaO2/FiO2<150)."
16004435|NCT02855619|Procedure|EDRIC|"The physiotherapist perform the IMT using the threshold IMT inspiratory muscle trainer, connected to the intubation tube. He manage the resistance at 30% of the Maximal Inspiratory Pressure of the day for the first set of 20 breaths with a resistance 's increasment of 10% at each set. Participant repeats 4 sets of 20 breaths with 2 minutes of resting with mechanical ventilation between each set.
~This treatment is made twice a day, 7days per week from inclusion to extubation exept if Glasgow score is under 8, hyperthermia more than 39°c, haemodynamic's instability, or hypoxemia( PaO2/FiO2<150)."
16004436|NCT02855567|Device|Acupuncture needles|Acupuncture needles (29 and 30 gauge) used to perform the acupuncture
16004437|NCT02855554|Other|Cardiac Magnetic Resonance (CMR) imaging techniques|Evaluation of clinical potential of fast quantitative myocardial tissue characterization using recently emerged CMRI techniques to aid the diagnosis, treatment, and follow up of patients with myocardial diseases.
16004438|NCT02855541|Device|DeskCycle|A small cycling ergometer that can fit under a desk at the workplace.
16004439|NCT02855528|Device|Tin Filter|
16004440|NCT02855515|Procedure|Short-time diagnostic anaesthesia|Patients will undergo a short-time general anaesthesia in order to diagnose Obstructive Sleep Apnoea when relaxed.
16004441|NCT02855502|Drug|Prednisolone|
16004442|NCT02855502|Drug|Placebo|
16004443|NCT02855489|Behavioral|Attitudes Only|
16004444|NCT02855489|Behavioral|Norms Only|
16004445|NCT02855489|Behavioral|Perceived Behavioral Control Only|
16004446|NCT02855489|Behavioral|Intentions Only|
16004447|NCT02855489|Behavioral|Three Constructs|
16004448|NCT02855489|Behavioral|Four Constructs|
16004449|NCT02855450|Drug|rhNGF|Recombinant Human Nerve Growth Factor 180μg/ml (one 35 μl drop equals to 6.30 μg of rhNGF) reconstituted solution three times a day (TID) for 8 weeks of treatment.
16004450|NCT02855450|Drug|Vehicle|Ophthalmic Placebo solution of the same composition as the test product with the exception of rhNGF reconstituted solution times a day (TID) for 8 weeks of treatment.
16004451|NCT02855437|Device|IVR (Phone call)|IVR will auto dial participants at a schedule time. Participants complete questions using their phone keypad. Participants can also call the IVR to complete surveys if they experience a flare. The IVR will be programmed to call the patient weekly for 26 weeks to complete a weekly Gout Flare Survey and Patient Reported Outcomes Survey. Consistent with the published gout flare self-report definition, gout flare ascertainment questions will include whether the recent flare is similar to past flares, the number of swollen joints and the number of warm joints. Pain at rest during the attack will be assessed on a 0-9 scale. Further questions will include peak pain, timing of attack and duration of attack if completed. We will capture patient reported outcome measures (e.g. pain, fatigue, sleep) using instruments from NIH PROMIS. Following completion of 26 week IVR period participants will crossover to RheumPro arm.
16004500|NCT02855060|Device|Pelvic Binder|
16004501|NCT02855034|Other|Blood samples|Blood samples for dosage: copeptin and protein S100B
16004525|NCT02854748|Drug|Empagliflozin 25mg/Lobeglitazone 0.5mg|Empagliflozin 25 mg + Lobeglitazone 0.5mg QD for 5 days
16004526|NCT02854735|Other|Imaging by CT and densitometry|Imaging by CT and densitometry, no intervention involved
16004452|NCT02855437|Device|RheumPro (Smartphone application)|"RheumPRO will be programmed to notify participants weekly for 26 weeks via a scheduled pop-up to complete Gout Flare and Patient Reported Outcomes Surveys. Participants self-navigate through the survey questions using their smartphone. If participants do not complete the Gout Flare or Patient Reported Outcomes surveys RheumPro will generate 2 more pop-ups at the same time over the proceeding 2 days (eg. Tuesday 4 PM, Wednesday 4 PM). Participants can also open the RheumPro application on their smartphone and complete surveys or if they experience a flare on a day they are not scheduled to complete a survey. Following completion of 26 week RheumPro period participants will crossover to IVR arm."
16004453|NCT02855424|Other|the low-intensity exercise group|Totally 20-time training, frequency 2-6 time/week, total 20 times.
16004454|NCT02855424|Other|the moderate-intensity exercise group|Totally 20-time training, frequency 2-6 time/week,total 20 times.
16004455|NCT02855411|Drug|PF-04958242|Administered as specified in the treatment arm
16004456|NCT02855411|Drug|placebo|placebo, twice daily (BID) for 12 weeks, capsule
16004457|NCT02855372|Procedure|Lung transplantation|
16004458|NCT02855359|Drug|denintuzumab mafodotin|SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles
16004459|NCT02855359|Drug|rituximab|375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
16004460|NCT02855359|Drug|cyclophosphamide|750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
16004461|NCT02855359|Drug|doxorubicin|50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
16004462|NCT02855359|Drug|vincristine|1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
16004463|NCT02855359|Drug|prednisone|100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
16004464|NCT02855346|Combination Product|200 mg of DPV + 320 mg LNG|DPV VR, containing 200 mg DPV
16004465|NCT02855346|Combination Product|200 mg of DPV|DPV-LNG VR, containing 200 mg of DPV + 320 mg LNG
16004466|NCT02855333|Other|EORTC and QLQ-C30 / QLQ-OES24 questionnaire|EORTC and QLQ-C30 / QLQ-OES24 questionnaire was sent to patients to asses QoL after MER or CON procedure
16004467|NCT02855320|Other|Nurse-led self-management education intervention|A nurse education consultation at M 0 and M3 in addition to the usual care by the rheumatologist. The nurse will assess the patients' health beliefs and educational needs, focusing on safety skills, self-injections and motivation. The control group will have usual care by the rheumatologist.
16004468|NCT02855307|Other|60-minute exercise|Patients will be admitted at the research clinical facility at 6:30. The artificial pancreas intervention will start at 7:00. A standardized breakfast will be served at 8:00. At 9:30, patients will performed a 60-minute exercise on the ergocycle at 60% of VO2 max. At 11:30, patients will be switched to standard insulin pump therapy and a lunch will be served. Patients will be discharged after lunch consumption.
16004469|NCT02855307|Device|Insulin pump|Patient's insulin pump will be used to infuse insulin.
16004470|NCT02855307|Device|Dexcom G4 Platinum glucose sensor|The Dexcom G4 Platinum glucose sensor will be used to measure glucose levels.
16004471|NCT02855307|Drug|Insulin|Patient's usual fast-acting insulin analog will be used.
16004472|NCT02855307|Other|Single-hormone closed-loop strategy|Variable subcutaneous insulin infusion rates will be used to regulate glucose levels. Patient's usual fast acting insulin analog (Lispro, Aspart or Guilisine) will be infused using the patient's pump. The glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom Inc.) will be entered manually into the computer every 10 minutes. The pump's infusion rate will then be changed manually based on the computer generated recommendation infusion rates.
16004473|NCT02855294|Drug|COC containing 30 μg of EE and 3mg of drospirenone|treatment for 6 consecutive cycles. Each treatment cycle consisted of 3 weeks of pill treatment followed by a 1-week pill-free period.
16004474|NCT02855268|Drug|lademirsen (SAR339375)|Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
16004475|NCT02855268|Drug|Placebo|Pharmaceutical form: Solution for injection Route of administration: Subcutaneous injection
16004476|NCT02855255|Behavioral|NHS 1-1 smoking cessation programme.|Smoking cessation using cognitive behavioural therapy/motivational interviewing
16004477|NCT02855255|Behavioral|Group smoking cessation programme|Smoking cessation using Allen Carr's Easyway method being delivered in a spoken form.
16004478|NCT02855242|Behavioral|Lifestyle Counseling|Participation in weekly group sessions over a period of 10 weeks, with information on healthy nutrition and exercises promoting weight loss
16004479|NCT02855242|Other|Controls Group|Subjects not participating in any lifestyle counseling
16004480|NCT02855229|Drug|Methylphenidate|cross-over, single-dose intervention
16004481|NCT02855216|Other|Manual technique of sub-occipital inhibition|
16004482|NCT02855216|Other|Self-treatment by way of Occipivot®|
16004483|NCT02855203|Radiation|Stereotactic Ablative Body Radiosurgery (SABR)|18-20Gy in 1 fraction
16004484|NCT02855203|Drug|Pembrolizumab|Pembrolizumab at a dose of 200mg IV, 3-weekly will be delivered for a duration of 6 months, commencing 5 days (+/- 3 days) from the last dose of SABR.
16004485|NCT02855190|Other|68Ga-citrate and 18F-FDG PET scans|68Ga-citrate and 18F-FDG PET/CT or PET/MR scans before operations
16004486|NCT02855177|Drug|Placebo|Placebo as suspension administered every 8 hours, with food
16004487|NCT02855177|Drug|PF-06427878|500 mg suspension administered every 8 hours, with food
16004488|NCT02855164|Drug|Tropifexor (LJN452)|Comparison of different doses of drug
16004489|NCT02855164|Drug|Placebo|Comparator
16004490|NCT02855138|Drug|oral isotretinoin|
16004491|NCT02855125|Drug|TAS-114|TAS-114 is a modulator of 5-fluorouracil (5-FU).
16004492|NCT02855125|Drug|S-1|S-1 was designed to provide oral delivery of 5-FU and to reduce the rate of degradation of 5-FU in vivo.
16004493|NCT02855112|Biological|Adipose derived mesenchymal stem cell|Allogeneic Adipose derived Mesenchymal Stem cell transplant
16004494|NCT02855099|Other|Rehabilitation|The duration on the rehabilitation will be 3 month and will be a multidisciplinary program that includes supervised physical activity
16004495|NCT02855086|Biological|Cetuximab|Administered intravenously (IV)
16004496|NCT02855086|Drug|Cetuximab-IRDye 800CW|Administered intravenously (IV)
16004497|NCT02855086|Procedure|Tumor resection|Standard of care treatment
16004502|NCT02855021|Other|Explorations|"Imaging tests and neuropsychological assessment are carried out within 60 days following patient enrollment.
~Neuropsychological assessment lasts 1:30 to 2:00 hours and is conducted by a psychologist in an interview during which patient will pass several tests on memory, language, attention or orientation in space.
~These tests do not require discontinuation of Parkinson's disease treatment."
16004503|NCT02855008|Behavioral|STEPS|Agencies providing residential services to individuals with ID gave us letters of agreement (N=9) when we submitted for funding. We randomized these agencies and followed the specific order. Over the past year, recruitment issues have resulted in our only being able to recruit at six of the original nine agencies. To address the issues, we compiled a list of 15 additional local agencies within a 50 mile radius. We are recruiting from an additional six agencies and are in contact with another four. We also changed our recruitment criteria to include co-ed homes. Within each agency we then, (1) determine homes that that meet criteria and, by gender (male, female, co-ed), randomize to STEPS or attention-control condition. Residential staff are consented first. Individuals with ID (or guardians if they have one) are then consented. 18 homes will participate in STEPS.
16004504|NCT02855008|Behavioral|Food for Life|Agencies providing residential services to individuals with ID gave us letters of agreement (N=9) when we submitted for funding. We randomized these agencies and followed the specific order. Over the past year, recruitment issues have resulted in our only being able to recruit at six of the original nine agencies. To address the issues, we compiled a list of 15 additional local agencies within a 50 mile radius We are recruiting from an additional six agencies and are in contact with another four. We also changed our recruitment criteria to include co-ed homes. Within each agency we then, (1) determine homes that that meet criteria and, by gender (male, female, co-ed), randomize to STEPS or attention-control condition. Individuals with ID and staff are recruited after randomization. Residential staff are consented first. Individuals with ID (or guardians if they have one) are then consented. 18 homes will participate in Food for Life.
16004505|NCT02854995|Procedure|circumcision|(i) circumcision: this will be a standard surgical circumcision whereby the prepuce (foreskin of the penis) is excised and the cut edge of the outer prepuce sutured to the cut edge of the inner prepuce. The two study team members performing the surgery in this trial (HC and SK) will be free to choose the method of circumcision (e.g. guillotine vs. sleeve) as this is not thought to influence outcome. The foreskin will be sent for histological analysis.
16004506|NCT02854995|Procedure|preputioplasty with intralesional injection of triamcinolone:|(ii) preputioplasty with intralesional injection of triamcinolone: this will be performed as described by Wilkinson et al.[5] Briefly, longitudinal incisions will be placed in the area of phimosis, and these will be sutured transversely to allow the prepuce to become retractile. A biopsy of an area of affected foreskin will be sent for histological analysis. The intention will be to perform three incisions (tri-radiate) but the final decision on how many will be made by the operating surgeon and based on the appearance of the prepuce and result of initial incision(s). Once the prepuce is felt to be freely retractile, 1 - 3 mL of triamcinolone (Adcortyl Bristol-Myers Squibb 10 mg/mL) will be injected intradermally around the circumference of the affected foreskin using a 25-gauge needle.
16004507|NCT02854982|Procedure|therapeutic management of the prostate Cancer as usual|
16004508|NCT02854969|Behavioral|Device: Anapphylaxis|
16004509|NCT02854956|Behavioral|Neuropsychological, cognitive and behavioral assessment|"The assessment includes mainly :
~The Raven's Progressives matrices test which allow to assess the non-verbal reasoning mental age of the patient
~The Wechsler scale or Brunet Lézine scale which allow to assess The Intellectual Quotient
~The Peabody Picture Vocabulary Test Revised which allow to determine the Vocabulary age (receptive language).
~The Vineland adaptive behavioral scale which allow to assess the adaptive behavior
~The Nisonger child behavior rating form which allow to assess the behavior disorders
~Analogical visual reasoning task (eye-tracking assessment and behavior assessment) which allow to identify the strategy used to solve the task and provides an objective and quantitative assessment of visual analogical reasoning and cognitive inhibition.
~Kinematic analysis of a grasping movement which allow to study the effect of the orientation and the type of pinch on the movement duration and both the transport component and the grasp component."
16004510|NCT02854930|Other|questioning|
16004511|NCT02854904|Drug|Dexmedetomidine intervention|Immune effect of alpha-2 agonist to arthrodesis. Dexmedetomidine as a immune control anesthesic in patients undergoing to arthrodesis. Alpha-2 agonist to general anaesthesia.
16004512|NCT02854904|Drug|Placebo|Placebo controlled
16004513|NCT02854891|Other|autorefractometer, A-scan ultrasound|A measurement of refraction will be made by the Autorefractometer. A measurement of the eyes' biometer data will be made by A-scan ultrasound.
16004514|NCT02854878|Device|The Lucy ultrasonic comb models A and B combined with the LucyGel|
16004515|NCT02854865|Other|echocardiography|assess whether GLPSS measured during cardiac surgery using AFI is superior to E/Ea ratio in estimation of LVFP measured as PCWP
16004516|NCT02854839|Biological|MG4101|MG4101 is ex vivo-expanded, allogeneic natural killer cells. MG4101 were manufactured from normal healthy donor who underwent lymphopheresis under good manufacturing practice (GMP) conditions.
16004517|NCT02854826|Other|SAFE Care model of care|"SAFE Care Model Site Intervention:
~Endorse best practices for frail patients;
~Identify frail patients promptly using multi-dimensional screening and assessments;
~Employ interprofessional unit-based care team approach to frailty risk reduction during inpatient stay and create post-acute care transitions (PACT) plan recommendations;
~Develop electronic health record templates for patient-centered interprofessional frailty notes;
~Communicate PACT plans to primary care providers to promote safe transitions to the ambulatory setting and across the continuum of care.
~Increase awareness, improve management of frailty, and improve overall health and well-being for adults who are frail or at risk of becoming frail."
16004518|NCT02854800|Drug|varenicline|Participants followed the schedule of dosing that is specified on the label: 0.5 mg once daily (Days 1-3), 0.5 mg twice daily (Days 4-7), and 1 mg twice daily (Days 8-84).
16004519|NCT02854787|Drug|Phenylephrine|A bolus of 100 mcg
16004520|NCT02854787|Drug|Norepinephrine|A bolus of 0,2 mcg/kg
16004521|NCT02854774|Behavioral|Muscle activation exercises|Activation of either muscles activating the knee or hip.
16004522|NCT02854761|Drug|EF-022 (Modified Vitamin D Binding Protein Macrophage Activator)|
16004523|NCT02854748|Drug|Empagliflozin 25mg|Empagliflozin 25 mg QD for 5 days
16004524|NCT02854748|Drug|Lobeglitazone 0.5mg|Lobeglitazone 0.5mg QD for 5 days
16004527|NCT02854722|Drug|Deferasirox and calcium-vitamin D3|"deferasirox and calcium-vitamin D3 Deferasirox is an orodispersible tablet and should be taken daily 30 minutes before breakfast, with a dose of 10 mg/Kg/day ± 5 mg/Kg/day during 12 month.
~Calcium 500 mg and vitamin D3 800 IU should also be taken daily as a basic therapy."
16004528|NCT02854722|Drug|Calcium-vitamin D3|Calcium 500 mg and vitamin D3 800 IU are taken daily as a basic therapy.
16004529|NCT02854709|Behavioral|Sleep extension|Sleep extension by 1 hour for 2 weeks
16004530|NCT02854696|Procedure|Islet graft|Patients will be transplanted with pancreatic islet cells
16004531|NCT02854696|Drug|best medical care|Patients will continue their insulin treatment
16004532|NCT02854683|Drug|Normal Saline|1 liter of intravenous saline will be delivered over 1 hour
16004533|NCT02854683|Dietary Supplement|Oral Rehydration Solution|1 liter of ORS solution given by mouth
16004534|NCT02854670|Drug|Capsaicin patch|After a pre-medication with paracetamol, patches are applied and removed after 20 minutes. Patients remain under observation for 2 hours after removal.
16004535|NCT02854657|Behavioral|Skin Self- examination structured training|A PowerPoint presentation will be provided as a PDF file. The file will be available in English and Spanish. This is the same skin self-examination structured training intervention used in the original RCT (MoleScore)
16004536|NCT02854644|Other|additional blood sample|
16004537|NCT02854631|Drug|Selonsertib|18 mg tablet administered orally once daily
16004538|NCT02854631|Drug|Prednisolone|40 mg (4 x 10 mg tablets) administered orally once daily
16004539|NCT02854631|Drug|Placebo|Selonsertib placebo tablet administered orally once daily
16004540|NCT02854618|Other|additional blood sample|
16004541|NCT02854605|Drug|GS-9674|Tablet administered orally once daily
16004542|NCT02854605|Drug|Placebo to match GS-9674|Tablet(s) administered orally once daily
16004543|NCT02854592|Drug|rtPA|intravenous thrombolysis with rtPa
16004544|NCT02854592|Drug|urokinase|intravenous thrombolysis with urokinase
16004545|NCT02854579|Biological|neural progenitor cell|Neural progenitor cells are derived from the same aborted human fetal forebrain.
16004546|NCT02854579|Biological|Paracrine factors|The factors obtained from cultured human mesenchymal stem cells were concentrated 50 times
16004547|NCT02854579|Biological|progenitor cell and paracrine factors|Neural progenitor cells will be received after paracrine factors therapy
16004548|NCT02854566|Device|osteosynthesis|Fracture reduction and fixation with screws/plates/cables (standard of care)
16004549|NCT02854553|Procedure|Transversus abdominis plane block|ultra sound guides Transversus abdominis plane block
16004550|NCT02854553|Procedure|rectus sheath block|ultrasound guided rectus sheath block
16004551|NCT02854540|Device|Hydrogel electrode-based iontophoresis|Hydrogel was administered through iontophoresis, a process of transdermal drug delivery by use of a voltage gradient on the skin.
16004552|NCT02854527|Drug|Digoxin|single dose
16004553|NCT02854527|Drug|Furosemide|single dose
16004554|NCT02854527|Drug|Metformin|single dose
16004555|NCT02854527|Drug|Rosuvastatin|single dose
16004556|NCT02854527|Drug|Digoxin|0.25 mg digoxin as single dose (all 4 drugs given together as a cocktail at the same time point)
16004557|NCT02854527|Drug|Furosemide|1 mg furosemide as single dose (all 4 drugs given together as a cocktail at the same time point)
16004558|NCT02854527|Drug|Metformin hydrochloride|10 mg metformin hydrochloride as single dose (all 4 drugs given together as a cocktail at the same time point)
16004559|NCT02854527|Drug|Rosuvastatin|10 mg rosuvastatin as single dose (all 4 drugs given together as a cocktail at the same time point)
16004560|NCT02854514|Procedure|Aspiration of endometrial secretion|intra uterine flushing of the endometrial cavity by five millilitre of saline through embryo transfer catheter then aspirated then centrifuged then analyzed for detection of concentration of tumor necrosis factor a and interleukin 1 b
16004561|NCT02854488|Drug|Yervoy|
16004562|NCT02854475|Procedure|Venous blood collection|weekly within two weeks
16004563|NCT02854475|Procedure|Raman spectroscopy|weekly within two weeks, on the volar forearm, using a RiverDiagnostics gen2-SCA Skin Composition Analyzer
16004564|NCT02854462|Behavioral|Language comprehension intervention|
16004565|NCT02854462|Behavioral|Counting intervention|
16004566|NCT02854436|Drug|Niraparib|Participants will receive 300 mg niraparib (3 capsules*100 mg) orally once daily.
16004567|NCT02854423|Device|percutaneous coronary interventions|Consecutive diabetic patients undergoing percutaneous coronary interventions with Biodegradable polymer Biolimus Eluting Stent or durable polymer Everolimus Eluting Stent implantation
16004568|NCT02854410|Dietary Supplement|Sodium nitrate|Dietary intake:Sodium nitrate 0.5mmol/kgbodyweight,bid
16004569|NCT02854410|Dietary Supplement|sodium chloride|Dietary intake:sodium chloride 0.5mmol/kgbodyweight,bid
16004570|NCT02854397|Other|blood sample|
16004571|NCT02854371|Drug|gadoxetic acid enhanced liver MRI|"Gadoxetic acid enhanced liver MRI is performed and the standard dose of contrast media (0.025mmol/kg) is administered intravenously at a rate of 1mL/sec. Before and after contrast media injection, T1 map sequence is performed to calculate hepatocyte fraction.
~Routine MR sequences (T2WI, T1WI, dual-echo sequence, DWI, MR elastography) are performed according to clinical protocol in the institution."
16004572|NCT02854371|Drug|ICG R15|ICG R15 (Indocyanine green retention test) is performed within 3 days after gadoxetic acid liver MRI, according to clinical standard protocol.
16004573|NCT02854358|Drug|mixed powder of A. digitata and M. sylvestris|
16004574|NCT02854358|Drug|Hypozalix spray (artificial saliva)|Hypozalix spray (artificial saliva)
16004575|NCT02854345|Device|Tomoscintigraphic parathyroid imaging on a CZT camera|
16004576|NCT02854332|Device|tDCS session|Direct current transcranial magnetic stimulation
16004577|NCT02854332|Device|rTMS session|Repetitive transcranial magnetic stimulation.
16004578|NCT02854319|Device|LOTUS Edge Valve System|Transcatheter Aortic Valve Implantation (TAVI) with the LOTUS Edge™ Valve System when used with the Lotus™ or iSleeve™ Introducer Set
16004579|NCT02854306|Procedure|Bariatric surgery|With mindfulness programm
16004580|NCT02854306|Procedure|Bariatric surgery|Without mindfulness programm
16004752|NCT02852824|Drug|BI 655130|
16004753|NCT02852824|Drug|Placebo|
16004581|NCT02854293|Other|Booklet-Question List|"Booklet-Question List (BQL) proposed in palliative cares, divided into 8 chapters, given to the patient before the first palliative care consultation.
~Providing a list of questions to patients and their families without any obligations allows individual adaptation of information; patients or families who are afraid of asking these questions can take advantage of this opportunity, while respecting the need to avoid these subjects for other patients"
16004582|NCT02854280|Biological|Pedalling exercise on a cycle ergometer|At 80% of the maximal aerobic power, until exhaustion
16004583|NCT02854280|Biological|Isolated contractions of the quadriceps|Until exhaustion
16004584|NCT02854254|Device|peripherally inserted central catheter|peripherally inserted central catheter
16004585|NCT02854254|Device|peripherally venous access|standard over-the-needle intravenous catheter
16004586|NCT02854241|Procedure|Biannual ultrasonography|Biannual ultrasonography for HCC surveillance, performed by board-certified radiologists.
16004587|NCT02854241|Procedure|Annual noncontrast liver MRI|"Annual noncontrast liver MRI consisted of T2WI, precontrast T1WI, dual-echo image, DWI (single shot, multishot) and T2 map.
~DWI using multishot and T2 map are not included for initial MR reading."
16004588|NCT02854241|Procedure|Contrast enhanced liver CT|In patients without report of HCC during surveillance period, contrast CT is performed 6 months after the last MR scan.
16004589|NCT02854215|Other|Collection of additional data with questionnaires|"questionnaires for quality of life measurements: QLQC30; QLQ-OV28
~questionnaires for medico-economic purposes: ADL (activities of daily living); IADL (instrumental activities of daily living); EQ-5D3L; absenteeism questionnaire.
~These questionnaires will be completed during the study time (5 or 6 times during the treatment, next every 4 months during the first two years and then every 6 months during the third year of follow-up)."
16004590|NCT02854202|Other|Arm1: Whey protein|Arm1: Whey protein:The participants will consume 42 g protein, namely from Whey protein in the breakfast
16004591|NCT02854202|Other|Arm 2 Breakfast- other proteins|Arm 2 Breakfast- other proteins: The participants will be assigned to 42 g protein of other protein sources at breakfast
16004592|NCT02854202|Other|Arm 3 Breakfast- low protein|Arm 3: Low protein' :The participants will consume 22 g protein at breakfast
16004593|NCT02854189|Device|Oxford unicompartmental knee arthroplasty|The Oxford unicompartmental knee arthroplasty was applied in all patients with medial osteoarthritis knee.The Oxford unicompartmental knee arthroplasty is mobile bearing unicompartmental knee arthroplasty.
16004594|NCT02854176|Procedure|Somatosensory electrical stimulation|
16004595|NCT02854176|Procedure|Control|
16004596|NCT02854163|Drug|Secukinumab|All eligible patients registered into the study will receive four 150 - 300 mg subcutaneous injections at weekly intervals, followed by regular injections 150mg once a month thereafter for a total of 12 months
16004597|NCT02854150|Genetic|characterization of variants in new genes using high throughput sequencing either on a panel of targeted genes or on exome in families.|
16004598|NCT02854137|Drug|BAY987521|10 micro L of the appropriate test product is place into the lower conjunctival sac of the designated eye (Formulation code: Y49-103).
16004599|NCT02854137|Drug|Control|10 micro L of the appropriate controlled product is place into the lower conjunctival sac of the designated eye.
16004600|NCT02854124|Procedure|Melanoma and peritumoral skin excision|Surgical retrieval of the primary tumor and safety retrieval of the surrounding normal peritumoral skin and sentinel lymph node
16004601|NCT02854111|Other|ice cream|The ice cream was made by nutritionists in Ramathibodi Hospital. It consisted of cornstarch, milk, sucrose, milk powder, egg yolk, and banana which contained carbohydrate 73.9 g, fat 27.7 g, protein 18.9 g for a total of 620.9 kcal with a cost of 35 bahts. The time for complete ingesting 75-g glucose and ice cream was 5 and 15 minutes, respectively.
16004602|NCT02854111|Other|75 g-glucose|The 75-g glucose is used for standard oral glucose tolerance test.
16004603|NCT02854085|Behavioral|Art Therapy|The Art Therapy will consist of creating art pieces, narrating thoughts and inner experiences in relation to the pieces produced (2 sessions a month) and guided visits to the art gallery (one session a month) and art museum (one session a month); there will be 12 sessions weekly for 12 weeks. For the next 6 months, sessions will be fortnightly and consist of creating an art piece once a month alternating with a visit to either the art museum or gallery, once a month; there will be 12 sessions in 6 months. Each session will last 45 minutes and will begin with 5 minutes of mindful relaxation to help participants focus on the task ahead.
16004604|NCT02854085|Behavioral|Music Reminiscence Activity|Music Reminiscence activity will be held weekly for 12 weeks and fortnightly for 6 months. Each session will last 45 minutes and will begin with 5 minutes of mindful relaxation to help participants focus on the task ahead. Session will entail listening and watching music videos and discussing activities, events and experiences related to the music; additional prompts such as photographs may be used to facilitate therapy.
16004605|NCT02854072|Drug|GV1001|At week 1, GV1001 will be administered intradermally on day 1, day 3 and day 5. This will be followed by a once weekly schedule for weeks 2, 3, 4 and 6. After that, GV1001 will be administered once monthly until withdrawal from trial treatment due to patient choice, intolerable toxicity or disease progression. GM-CSF will be used as an adjuvant, given 10-15 minutes prior to each administration of GV1001.
16004606|NCT02854072|Drug|Gemcitabine|Gemcitabine 1000 mg/m^2 will be intravenously administered on day 1,8 and 15 followed by 7 days' rest.
16004607|NCT02854072|Drug|Capecitabine|Capecitabine 830 mg/m^2 will be orally given in the morning and evening (total dose of 1660 mg/m^2) for 21 days followed by 7 days' rest.
16004608|NCT02854059|Biological|IdeS (0.25 mg/kg)|Single i.v. infusion of IdeS (0.25 mg/kg). Following an evaluation of efficacy and safety in the first 3 patients the dose may be increased in the following 3 patients to 0.5 mg/kg.
16004609|NCT02854059|Biological|IdeS (0.50 mg/kg)|Single i.v. infusion of IdeS (0.50 mg/kg).
16004610|NCT02854046|Other|Calcific Uremic Arteriolopathy|
16004611|NCT02854007|Device|Coronary angioplasty with implant of bioresorbable device|Percutaneous coronary intervention
16004612|NCT02853981|Device|Harmonic scalpel|a method for liver parenchymal transection
16004613|NCT02853981|Device|Kelly clamp crush technique|a method for liver parenchymal transection
16004614|NCT02853968|Procedure|Blood draw/buccal swab|The research project will need a blood sample of no more than 50mL per two month period. The research project may also request a buccal swab from patients if needed.
16071139|NCT02374567|Drug|Imipramine|
16004615|NCT02853955|Device|Percutaneous edge-to-edge repair of the mitral valve|MitraClip in patients with recurrent MI after surgical mitral valve repair.
16004616|NCT02853942|Biological|Autologous adipose stem cell therapy|
16004617|NCT02853942|Drug|Mecobalamin|
16004618|NCT02853929|Biological|Infanrix hexa|All subjects will receive Infanrix hexa co-administered with Prevenar13 as a booster dose.
16004619|NCT02853916|Dietary Supplement|500 mg InSea2®|
16004620|NCT02853916|Dietary Supplement|250 mg InSea2®|
16004621|NCT02853916|Dietary Supplement|Placebo|
16004622|NCT02853903|Biological|NK immunotherapy|Each treatment: 8-10 billion cells in all, transfusion in 3 times, i.v.
16004623|NCT02853890|Other|Questionnaires during hospitalization for delivery|Questionnaires during hospitalization for delivery (one questionnaire completed by doctors about different technic of analgesia and anesthesia and one questionnaire completed by women about pain, and feeling about the different techniques of analgesia and anesthesia used during delivery, eventually caesarean section or uterine revision)
16004624|NCT02853877|Behavioral|Weekly Incentive|The tailored incentives intervention aims to assess the impact of tailored messaging and financial incentives on weight loss among obese employees.
16004625|NCT02853864|Drug|0.0 ng/ml Dexmedetomidine|Dexmedetomidine target plasma concentration is 0.0 ng/ml
16004626|NCT02853864|Drug|0.4 ng/ml Dexmedetomidine|Dexmedetomidine target plasma concentration is 0.4 ng/ml
16004627|NCT02853864|Drug|0.6 ng/ml Dexmedetomidine|Dexmedetomidine target plasma concentration is 0.6 ng/ml
16004628|NCT02853864|Drug|0.8 ng/ml Dexmedetomidine|Dexmedetomidine target plasma concentration is 0.8 ng/ml
16004629|NCT02853864|Drug|Propofol|The propofol infusion was started to provide an effect-site concentration of 1.0 ug/ml, and increased by 0.2 ug/ml until loss of consciousness
16004630|NCT02853851|Other|interviews|Each subject will be asked to participate in an individual semidirective interview lasting about 40 minutes on the theme of the stress factors encountered in intensive care. All of the interviews will be audio-taped, transcribed and anonymized. The participants will also have to answer a socio-demographic questionnaire (sex, age, socio-professional category, speciality in intensive care, working hours, family situation, training, diplomas, length of time in the service).
16004631|NCT02853838|Other|Prolonged slow expiration+provoked coughing|"Five cycles of prolonged slow expiration and provoked coughing, which will be repeated five times.
~During the prolonged slow expiration, the infant will be in supine while the therapist applies pressure at the same time on the rib cage and abdomen during spontaneous expiration. The pressure is applied slowly during two o three respiratory cycles, only during the final phase of expiration."
16004632|NCT02853838|Other|Manual chest wall vibration|"Five cycles of manual chest wall vibrations during 20 seconds each, being repeated five times.
~The manual chest wall vibrations are oscillatory maneuvers applied on the thorax to improve mucociliary clearance of bronchial mucus and ease its removal."
16004633|NCT02853838|Other|Standard Therapy|Standard therapy (ST): nasopharyngeal suction, oxygen therapy, fluids administration, 0.5% adrenaline nebulization, and chest physiotherapy.
16004634|NCT02853825|Behavioral|Relationship Skill Enhancement|Receive relationship classes with access to parenting, employment services, and financial services.
16004635|NCT02853812|Other|Functional brain MRI|Sound evoked functional MRI assessment on patients with single sided tinnitus
16004636|NCT02853799|Other|Comparison of the Effects of Intermittent and Continuous Enteral Feeding on Glucose-Insulin Dynamics in Critically Ill Medical Patients|"Placement of feeding tube stomach (oral- or naso-gastric tube)
~Randomized to receive either continuous feeding or intermittent feeding first. Once at goal nutrition for 4 hours, enter first 4-hour data collection interval. Next proceed with cross-over and complete a 4-hour washout period with the feed type. Finally enter second 4-hour data collection period. To enter into the first data collection period, the patient would require an insulin infusion.
~There will be five blood glucose checks in each data collection period.
~If two blood glucose concentrations are above 180 mg/dl then a regular insulin infusion will be initiated."
16004637|NCT02853799|Dietary Supplement|Osmolite 1.2 cal/ml Enteral Feeds|Osmolite 1.2 cal/ml Enteral Feeds via feeding tube (oral- or naso-gastric tube)
16004638|NCT02853786|Behavioral|LENA and advice|Language recording with the LENA device, with the LENA results, we will advise the parents how to improve the language environment to help their children with CIs for their language development
16004639|NCT02853786|Other|LENA without advice|Language recording with the LENA device. Regular speech therapy follow blindly the results of LENA
16004640|NCT02853773|Other|ingestion of a test meal with sweetener|participants will ingest a test meal containing 55% carbohydrate, 30% fat and 15% protein with artificially sweetened drinks
16004641|NCT02853773|Other|ingestion of a test meal with sweetener|participants will ingest a test meal containing 55% carbohydrate, 30% fat and 15% protein with sugary drinks drinks
16004642|NCT02853773|Other|ingestion of a test meal with water|participants will ingest a test meal containing 55% carbohydrate, 30% fat and 15% protein with waters
16004643|NCT02853760|Behavioral|walking|
16004644|NCT02853760|Device|Treadmill|
16004645|NCT02853747|Behavioral|high-intensity-interval-training|12 weeks of walking-based HIIT training
16004646|NCT02853734|Other|SEVERE PERIODONTITIS|Patients exhibiting moderate to severe periodontitis
16004647|NCT02853734|Other|NO PERIODONTITIS|Patients without existing periodontitis or exhibiting mild periodontitis
16004648|NCT02853721|Other|iPTH|iPTH assay six hours after surgery
16004649|NCT02853721|Other|no dosage of iPTH|Ca and P on postoperative day 1 and 2
16004650|NCT02853682|Biological|plasma|assesment of glycocalyx protein
16004651|NCT02853669|Procedure|Ultrasound-guided Lumber Plexus Block|(30 cc of 0.25% of bupivacaine, via a 22-gauge 2-inch Stimuplex A needle) with nerve stimulator confirmation. The type of motor response (e.g., quadriceps, patellar) and the minimum current needed were recorded. Ultrasound pictures (preinjection and postinjection) were obtained to verify proper local anesthetic placement.
16004652|NCT02853669|Procedure|adductor canal block|ultrasound-guided Adductor Canal Block (15 cc of 0.5% of bupivacaine)
16004653|NCT02853643|Drug|ASN002|Single dose study with food effect
16004654|NCT02853630|Drug|Metformin|Participant will be instructed to take Metformin tablets as per instructions given by the physician.
16004754|NCT02852811|Other|Group education|Intervention involving two education session with topics common in menopause transition.
16004655|NCT02853630|Drug|Vildagliptin|Participant will be instructed to take one tablet of Vildagliptin 50mg per day, 30 minutes after breakfast in the morning and second tablet at night, 30 minutes after dinner
16004656|NCT02853617|Biological|AV0328 - Cohort 1|Cohort 1 will receive 15 µg to be given as an IM injection
16004657|NCT02853617|Biological|AV0328 - Cohort 2|Cohort 2 will receive 30 µg to be given as an IM injection
16004658|NCT02853617|Biological|AV0328 - Cohort 3|Cohort 3 will receive 75 µg to be given as an IM injection
16004659|NCT02853617|Biological|AV0328 - Cohort 4|Cohort 4 will receive 150 µg to be given as an IM injection
16004660|NCT02853604|Drug|ADXS11-001|
16004661|NCT02853604|Drug|Placebo|
16004662|NCT02853591|Procedure|Pneumoinsufflator mode and setting|Patients undergoing total laparoscopic hysterectomy will be randomized to pneumoperitoneum creation by one of two modes (standard or pressure-barrier) at one of two set pressures (15mmHg or 9mmHg) for a four-armed factorial designed study.
16004663|NCT02853578|Drug|Busonid (budesonide 200mcg and 400mcg)|"cartridge containing 60 tablets of 200 mcg or 400 mcg and an inhaler;
~1 application (inhalation) of 200mcg every 12 noon (400 mcg / day). During the visits of monitoring (V1 and V2) the doctor in charge assess the need to increase the dose of PSI 400mcg for every 12 hours (800mcg / day); treatment for 12 weeks."
16004664|NCT02853565|Drug|CAN008|The dose escalation in the phase I study including 200mg in the first cohort and 400mg in the second cohort to Recommended for Phase 2 Dose (RP2D)
16004665|NCT02853552|Drug|Misoprostol|800mcg misoprostol taken sublingually
16004666|NCT02853539|Drug|Denosumab|Subcutaneous injection of Denosumab
16004667|NCT02853526|Procedure|TIPS|Transjugular intrahepatic portosystemic shunt(TIPS)- TIPS was performed in a conventional fashion or in combination of percutaneous transhepatic or transsplenic approach (p-TIPS). Oral warfarin was used for six months to one year prescribed at dosages to achieve an international normalized ratio (INR) of up to two times the upper limit of normal for the prevention of shunt dysfunction.
16004668|NCT02853526|Drug|Propranolol|Propranolol is a kind of non-selective beta blockers, and is used for reducing the portal pressure.
16004669|NCT02853526|Procedure|Endoscopic therapy|Endoscopic therapy includes the endoscopic variceal band ligation and sclerotherapy.
16004670|NCT02853526|Drug|Warfarin|Oral warfarin was used for six months to one year prescribed at dosages to achieve an international normalized ratio (INR) of up to two times the upper limit of normal.
16004671|NCT02853500|Device|Surefire|Surefire is a modified microcatheter with an expandable cone at its tip to prevent retrograde reflux of flow and change flow dynamics downstream.
16004672|NCT02853500|Device|Traditional Delivery|Low profile tubing microcatheter for easier access to more peripheral/distal vascular branches for precise targeted delivery of medications.
16004673|NCT02853500|Drug|Doxorubicin|Medication used in cancer chemotherapy, including intraarterial delivery for liver malignancies.
16004674|NCT02853487|Device|Actigraphy|An actigraph from Philips
16004675|NCT02853487|Other|Diary|Questions on sleep times and awakenings and attacks in the morning and evening for 2 weeks.
16004676|NCT02853474|Behavioral|Early Palliative Care visit|"A PC visit is a visit done by a PC physician. Any kind of visits done by other professionals IS NOT a PC visit.
~Five PC visits are scheduled in this arm."
16004677|NCT02853474|Other|EORTC-QLQ-C30 questionnaire|The Quality of Life is assessed with the QLQ-C30 questionnaire at baseline, 12 and 24 weeks after inclusion, as well as every 8 weeks thereafter.
16004678|NCT02853474|Other|HADS score|The depression is assessed with the HADS scale (Hospital Anxiety and Depression Scale) at baseline, and then 12 and 24 weeks after inclusion.
16004679|NCT02853461|Other|Sonication|Ultrasound bath (40 kHz, 1 W/cm2, 1 min) of bearing components of the prosthesis in sterile conditions.
16004680|NCT02853461|Other|Microbiological analysis|Plating the sonicates on agar plates.
16004681|NCT02853448|Device|Novel Blood Drawing Apparatus|
16004682|NCT02853435|Drug|Gepotidacin RC Tablet|The tablet is a capsule shape white film coated tablet with no identifying markings. This is an immediate release tablet containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets.
16004683|NCT02853435|Drug|Gepotidacin HSWG Tablet|The tablet is an oval shape white film coated tablet with no identifying markings. This is an immediate release tablets containing gepotidacin 750 mg (free base) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing tablets.
16004684|NCT02853435|Drug|Gepotidacin Capsule|It is a pink gelatin size 00 capsule with no identifying markings containing slightly agglomerated pale yellow to grayish yellow to yellowish gray powder. This is an immediate release capsules containing gepotidacin 500 mg (mesylate salt) and inactive formulation excipients administered orally with 240 mL of water. Up to an additional 100 mL of water may be given to assist in swallowing capsules.
16004685|NCT02853396|Other|Cognitive Behaviour Therapy|
16004686|NCT02853396|Other|Psychoeducation|
16004687|NCT02853370|Drug|Bendamustine and Rituximab|
16004688|NCT02853357|Other|Manipulation|"Middle Thoracic: Participants are placed in the supine position with their arms over their chest. The clinician rolls the participant to their side and places the fulcrum at the desired thoracic segment and the participant is rolled back onto the clinician's hand. The participant is instructed to take a deep breath. As the participant is exhaling, the clinician uses his body to push through the participant's arms to perform a high velocity thrust in an anterior to posterior directed force. Lower Thoracic: With the patient in a prone position, the clinician achieves a skin lock with both pisiforms over the transverse processes of the target vertebra. The clinician then uses his body to push down through his arms to perform a high-velocity, low-amplitude posterior to anterior thrust."
16004689|NCT02853357|Other|Sham Manipulation|The participants are positioned in prone and the clinician's hands are placed with the pisiforms of each hand over the transverse processes of the target vertebra. The clinician will only apply minimal pressure and slide the hands across the skin to mimic the manipulative thrust. This sham procedure has been shown to be an adequate sham comparator for spinal manipulative therapy (SMT) with similar expectations and believability as SMT active treatment
16004755|NCT02852798|Drug|Apatinib Combined With Docetaxel|Docetaxel 75 mg/ (m2.d)IV gtt 1h d1 q3w Apatinib Mesylate Tablets : 500 mg qd, 4 weeks as one cycle for continuous drug administration
16004690|NCT02853357|Other|Core Strengthening Exercises|Both groups will receive the following exercises at each visit. The core strengthening (core strengthening) exercises are a standard protocol used by Richardson et al and Franca et al which are proposed to target muscles responsible for segmental stabilization, specifically the transverse abdominis (TrA) and the lumbar multifidi (LM). Exercises will include: TrA exercises in 4 point kneeling and in supine with flexed knee, LM exercises in prone, and co-contraction of TrA and LM in upright position. Three sets of 15 repetitions will be done for each exercise.
16004692|NCT02853331|Biological|Pembrolizumab|Intravenous infusion
16004693|NCT02853331|Drug|Axitinib|Oral tablet
16004694|NCT02853331|Drug|Sunitinib|Oral capsule
16004695|NCT02853318|Biological|Bevacizumab|Given IV
16004696|NCT02853318|Drug|Cyclophosphamide|Given PO
16004697|NCT02853318|Other|Laboratory Biomarker Analysis|Correlative studies
16004698|NCT02853318|Biological|Pembrolizumab|Given IV
16004699|NCT02853305|Biological|Pembrolizumab|IV infusion
16004700|NCT02853305|Drug|Cisplatin|IV infusion
16004701|NCT02853305|Drug|Carboplatin|IV infusion
16004702|NCT02853305|Drug|Gemcitabine|IV infusion
16004703|NCT02853292|Biological|urine collection|
16004704|NCT02853279|Behavioral|Interval exercise training|"Interval exercise sessions (INT) involving work:recovery ratios of 40 s at 70% delta work-rate followed by 80 s active recovery at 20 W. 70% delta (∆) is 70% of the difference between work rate peak (WRpeak) and work rate at the lactate threshold (WRLT) calculated as:
~70%∆ =0.7(〖WR〗_peak- 〖WR〗_LT )+ 〖WR〗_LT
~Where WR is work rate, LT is lactate threshold)
~Each session was for 30 min and this was undertaken twice per week for 12 weeks. One home based exercise session was incorporated per week."
16004705|NCT02853279|Behavioral|Continuous exercise training (CON)|Exercise sessions involved cycling at 20%∆ work-rate peak for the duration of the session. This work-rate was chosen so that all participants in the group would be exercising in the heavy-intensity domain. To enable participants in the CON exercise group to complete the same amount of work (kJ) as the participants in the INT exercise group, the amount of work that would be completed if the CON participants completed an INT exercise session was calculated. Participants exercised for 26 min (varying to match interval group) twice per week for 12 weeks.
16004706|NCT02853266|Other|laboratory biomarker analysis|Archived serum samples are analysed for measurement of biomarker NCRA
16004707|NCT02853253|Dietary Supplement|SMOFlipid®|"SMOFlipid® (FreseniusKabi France, Sèvres, France). It is a 3rd generation LE containing a physical mixture of soybean oil (30%), MCT (30%), olive oil (25%) and fish oil (15%). Its ratio omega6/omega 3 is 2,5/1. SMOF will be initiated within the 1st day of life of neonates and will be prescribed daily by the attending physician following these guidelines: initiation rate: 1 g/kg/day; daily increase: 0.5 to 1 g/kg/day ; target: 3 to 4 g/kg/day.
~All included preterms will receive nutritional support according to a single protocol based on the ESPGHAN recommendations: parenteral glucose and amino acids (Primene 10%, Clintec Parenteral, Maurepas, France) soon after birth (in their 1st day of life). Initiation rate of parenteral glucose and amino acids will be 6 to 8 g/kg/day and 2 g/kg/day respectively. The daily increase of parenteral glucose and amino acids will be 1 to 2 g/kg/day and 0.5 g/kg/day respectively, for a target rate of 14 to 17 g/kg/day and 3.5 g/kg/day respectively."
16004708|NCT02853253|Dietary Supplement|Medialipide®|"Medialipide® 20% (B Braun Medical, Boulogne, France). It is a second generation LE containing soybean oil (50%) and MCT (50%). Its ratio omega6/omega 3 is 7/4. Medialipide will be initiated within the 1st day of life of neonates and will be prescribed daily by the attending physician following these guidelines: initiation rate: 1 g/kg/day ; daily increase: 0.5 to 1 g/kg/day; target: 3 to 4 g/kg/day.
~All included preterms will receive nutritional support according to a single protocol based on the ESPGHAN recommendations: parenteral glucose and amino acids (Primene 10%, Clintec Parenteral, Maurepas, France) soon after birth (in their 1st day of life). Initiation rate of parenteral glucose and amino acids will be 6 to 8 g/kg/day and 2 g/kg/day respectively. The daily increase of parenteral glucose and amino acids will be 1 to 2 g/kg/day and 0.5 g/kg/day respectively, for a target rate of 14 to 17 g/kg/day and 3.5 g/kg/day respectively."
16004709|NCT02853240|Procedure|Muscle biopsy|A biopsy (specifically done for the study) of a muscle that has already been injected with botulinum toxin before inclusion of the patient in the study will be performed, taken during a planned surgery (for tendon transfer or muscle lengthening). A biopsy of a muscle that has never been injected with botulinum toxin may be performed during surgery. No biopsy will be made on a member that would not require surgery. Thus sampling will be conducted on a muscle requiring a surgery: 2 to 3 millimeters will be taken on 10 mm muscle before transfer or lengthening.
16004710|NCT02853227|Other|digital photography|Photographies with digital cameras were taken postoperatively for the documentation, anonymised and used for evaluation of cosmetic results after surgery.
16004711|NCT02853214|Genetic|Genetic analysis of peripheral blood samples|M.D investigators report the identified families with all the information: description of the familial area (for example: 2 cases father and son), last medical report for the case with the type of dysglobulinemia, monoclonal component isotype, medical background and contact information for one of the patients or cases with Name/surname/Date of Birth/address and phone. They contact the patient to explain the study and establish the family pedigree. They collect the information on all the family members and send to the patient a mail: an information note on the study, a prescription for the blood sample and the informed consents. They proceed in the same way for the relatives with the additional prescription: EIP. They organize the logistic in the medical lab or hospital chosen by the person. They receive 4 Heparin and 1 serum tubes for each and with this, they obtain a large amount of biological material for the genetic analysis thanks to the establishment of lymphoblastoid cell lines
16004712|NCT02853188|Other|venous thromboembolism|
16004713|NCT02853162|Radiation|ARREST-study|Radiotherapy will be delivered in five fractions of 7 Gy every other day. An additional contrast enhanced MRI scan will be performed after the 2nd treatment fraction, and after 6 and 12 months
16004756|NCT02852785|Behavioral|PNF D2 for flexion; low-to-moderate loading condition|Exposure to upper extremity PNF D2 for flexion during low-to-moderate loading condition
16004757|NCT02852785|Behavioral|PNF D2 for flexion; moderate-to-high loading condition|Exposure to upper extremity PNF D2 for flexion during moderate-to-high loading condition
16004874|NCT02851810|Behavioral|attachment scale interview (ASI)|ASI is used to determine the attachment style of each participant
16004714|NCT02853149|Behavioral|Spinal Cord Injury (SCI)|"The SCI Intervention group will undergo intense exercise, a defined nutrition program, and an educational program taught by the study investigators. The exercise will require them to undergo supervised activity 3 times weekly for 6 months. They will also participate in a series of educational sessions that examine their lifestyle, and modify exercise/nutritional habits. After 6 months they will advance to another 6 months or extension phase in which the investigators expect them to continue to exercise up to 3 times per week at our center or at home by using elastic exercise bands (Thera-band) and handles that the Investigators will provide and teach how to use. They will also be expected to continue the modified nutritional program."
16004715|NCT02853149|Behavioral|Caregiver Intervention(CCC)|"The Caregiver Intervention group will undergo intense exercise, a defined nutrition program, and an educational program taught by the study investigators. The exercise will require them to undergo supervised activity 3 times weekly for 6 months. They will also participate in a series of educational sessions that examine their lifestyle, and modify exercise/nutritional habits. After 6 months they will advance to another 6 months or extension phase in which the investigators expect them to continue to exercise up to 3 times per week at our center or at home by using elastic exercise bands (Thera-band) and handles that the Investigators will provide and teach how to use. They will also be expected to continue the modified nutritional program."
16004716|NCT02853149|Behavioral|Caregiver Control (CC)|The Caregiver Control group will also discuss ways in which health and fitness can be improved through exercise and nutrition and will also be offered a fully paid membership to the an exercise fitness center to encourage them to exercise and consume a healthy diet. Unlike the Caregiver Intervention group(CCC) the lifestyle recommendations will be provided by internet authorities such as Web Medical(WebMD), the US Department of Agriculture, and the US Department of Human Health Services, which are dependable websites that promote healthy ways of living.
16004717|NCT02853136|Drug|Fluvoxamine|single dose
16004718|NCT02853136|Drug|BI 409306|low single dose
16004719|NCT02853136|Drug|BI 409306|medium or high dose
16004720|NCT02853123|Drug|Tiotropium|fixed dose combination once daily
16004721|NCT02853123|Drug|Olodaterol|fixed dose combination once daily
16004722|NCT02853123|Drug|Tiotropium|
16004723|NCT02853110|Radiation|Hypo-FLAME study|SBRT technique with 35 Gy in 5 weekly fractions and an additional simultaneously integrated focal boost to the tumor nodule(s) visible on MRI up to 50 Gy. In addition, patients will be asked to undergo 5 additional MRI scans (~15 min/scan) without contrast enhancement prior to each radiation session as well as blood sampling for translational research (radiogenomics) and Biobank purposes.
16004724|NCT02853097|Other|Cytology Specimen Collection Procedure|Undergo blood collection
16004725|NCT02853097|Other|Laboratory Biomarker Analysis|Correlative studies
16004726|NCT02853084|Drug|HL2351|The dose will be adjusted based on disease activities
16004727|NCT02853071|Drug|Estramustine|
16004728|NCT02853071|Drug|standard practice|standard practice
16004729|NCT02853058|Radiation|normal PI|measurement of the PI in the uterine artery for pregnant women during labor, expressed in MoM
16004730|NCT02853058|Radiation|pathological PI|measurement of the PI in the uterine artery for pregnant women during labor, expressed in MoM
16004731|NCT02853045|Drug|period with drug (trade name) then period with generic|"The list of drugs is detailed in the study description"
16004732|NCT02853045|Drug|period with generic then period with drug (trade name)|"The list of drugs is detailed in the study description"
16004733|NCT02853032|Device|Active repetitive transcranial magnetic stimulation|The MagPro R30 is an advanced, high performance magnetic stimulator designed primarily for non-invasive clinical use. The non-invasive brain stimulation system will be used to deliver active repetitive electromagnetic pulses in this research study's treatment of post-traumatic stress disorder.
16004734|NCT02853032|Device|robotic arm|This robotic system is based on a commercially available neurosurgical robot. The robot is mounted on a mobile (i.e. retractable wheels) cart which holds the robot controller and the TMS power supply and pulse-generation computer. The robotic system will be used for TMS coil positioning/targeting.
16004735|NCT02853032|Device|Sham repetitive transcranial magnetic stimulation|The MagPro R30 is an advanced, high performance magnetic stimulator designed primarily for non-invasive clinical use. The non-invasive brain stimulation system will be used to deliver placebo repetitive electromagnetic pulses in this research study's treatment of post-traumatic stress disorder.
16004736|NCT02853019|Other|Electroencephalogram|electrophysiological measurements (evoked potentials) based on neural activity when visualizing stimuli
16004737|NCT02853019|Behavioral|Cognitive tasks|- clinical scales and subjective assessments of emotional and motivational stimuli
16004738|NCT02853019|Behavioral|subjective evaluation scales|- clinical scales and subjective assessments of emotional and motivational stimuli
16004739|NCT02853006|Biological|Blood and respiratory fluids sampling|In order to extract RNA (LungCancerTest) and DNA (mutation, reassortment).
16004740|NCT02853006|Procedure|Biopsy|
16004741|NCT02853006|Procedure|Excised tissues|
16004742|NCT02852980|Other|gestational diabetes women|No intervention.
16004745|NCT02852941|Device|CardioScreen 1000|Haemodynamic Measurement System, Medis Impedance cardiography (ICG)
16004746|NCT02852941|Device|Tanita 418- Bioelectrical impedance analysis|The device measured the size of total body water (TBW), fat mass (FM%), visceral fat%, fat free mass (FFM), and basal metabolic rate (BMR) (kcal).
16004747|NCT02852915|Procedure|Laparoscopic surgery|Laparoscopic surgery for T4 cancer
16004748|NCT02852876|Drug|ASP2151|Oral
16004749|NCT02852876|Drug|Placebo|Oral
16004750|NCT02852863|Other|Gum|Subjects will fast for a minimum of 8 hours. A baseline ultrasound assesment will be performed to evaluate gastric content. Next, subjects will chew sugarless gum for one hour with changes of gum every 20 minutes (a total of 3 gums will be chewed per subject). Once the last gum is chewed, the gum will be disposed in the trashcan. Three more ultrasound assessments will take place: immediately after one hour of chewing gum, and at the first and second hour after chewing gum has stopped. The content will be classified as empty, with fluids, or with solid. In case of fluids, volume will be measured.
16004751|NCT02852837|Drug|Daratumumab|Intravenous (IV) infusion of 8 mg/kg or 16 mg/kg daratumumab.
16004758|NCT02852785|Behavioral|PNF D2 for extension; low-to-moderate loading condition|Exposure to upper extremity PNF D2 for extension during low-to-moderate loading condition
16004759|NCT02852785|Behavioral|PNF D2 for extension; moderate-to-high loading condition|Exposure to upper extremity PNF D2 for extension during moderate-to-high loading condition
16004760|NCT02852772|Behavioral|Cognitive function tests|
16004761|NCT02852759|Procedure|Selective Cold|The volunteers of intervention group will undergo Selective Cold treatment below 10 degree celsius to neck, supraclavicular interscapular regions for 2 hours daily for 8 weeks. The electroacupuncture is conducted by commercially available device. Hyperinsulinemic euglycemic clamp, glucose tolerance test, blood parameter measurements, and PTC-CT scans will be conducted before and after the intervention. The participants will be instructed to maintain their normal behavior and calorie intake.
16004762|NCT02852759|Device|Electroacupuncture|Electroacupuncture (EA) is an add-on treatment and it is applied when starting the cold treatment at the cold treated region to patients.The device is Huatuo SDZ-II model made by Suzhou Medical Appliance Factory, China.
16004763|NCT02852746|Behavioral|Performance measures of the upper extremity|Athletes will perform the unilateral seated shot put test (USSPT) and the upper quarter Y balance test (UQYBT) bilaterally.
16004764|NCT02852733|Other|end-of-life emergencies' management|
16004765|NCT02852720|Drug|Levobupivacaine|After the block procedure, 2 ml blood samples will be taken in defined times to determine the plasma blood levels of levobupivacaine.
16004766|NCT02852720|Procedure|Spinal anesthesia|Spinal anesthesia in the L3-L4 or L4-L5 interspace with hyperbaric bupivacaine 0,75% 1,4 ml plus 20 ug fentanyl to achieve a bilateral anesthetic level of T4 determined by pinprick.
16004767|NCT02852720|Procedure|Peripheral vein canulation|An intravenous (18-gauge) catheter will be placed under local anesthesia for co hydration and a second IV catheter for venous sampling
16004768|NCT02852720|Procedure|Ultrasonography|TAP blocks will be performed using a ultrasound Sonosite M-Turbo US machine (Sonosite Inc, Washington) with an L38x 10-5 megahertz (MHz), 38-mm broadband linear array probe.
16004769|NCT02852720|Device|Holter|A portable 12-lead Holter (NorthEast Monitoring®, Boston, USA) will record continuously the electrocardiogram (ECG) after the TAP block, for 24 hrs.
16004770|NCT02852707|Behavioral|Chronic exposure to unilateral overhead sports activity|"Overhead sports athletes that have been chronically exposed (≥ 2 years) predominantly to specific unilateral overhead movement patterns of the dominant extremity (throwing arm), such as throwing or hitting a ball (asymmetrical overhead sports)."
16004771|NCT02852707|Behavioral|Chronic exposure to bilateral overhead sports activity|"Overhead sports athletes that have been chronically exposed (≥ 2 years) predominantly to bilateral overhead movement patterns of the upper extremities, such as swimmers (symmetrical overhead sports)."
16004772|NCT02852707|Behavioral|Not exposed|People not engaged in regular sports competition/exercise training.
16004773|NCT02852694|Drug|Methotrexate|Subcutaneous methotrexate once weekly 15mg/m2 body surface area (19, 30), with a maximal dose of 25mg/week. Odansetron (Zofran) premedication (4-8mg 1Hour prior to injection) is recommended, folate acid substitution (15mg po, 3 days after Methotrexate injection, for children <20kg: 1x 5mg) is recommended.
16004774|NCT02852694|Drug|Adalimumab|Subcutaneous Adalimumab started at a dose of 160mg followed by 80mg 2 weeks later and then 40mg every 2 weeks in patients over 40kg. In patients < 40kg sc doses of Adalimumab are as follows: induction 160mg/1,73m2 BSA (max 160mg), followed by 80mg/1,73m2 Body surface area (max 80mg) 2 weeks later and maintenance of 40mg/1,73m2 Body surface area (max 40mg) every 2 weeks, all doses rounded up to the nearest 5 multiplications.
16004775|NCT02852694|Drug|Azathioprine / 6 Mercaptopurine|Oral Azathioprine /6mercaptopurine at a dose of 2.5 mg/kg once daily rounded to the nearest multiplication of 12.5mg or oral 6mercaptopurine at a dose of 1.5mg/kg once daily rounded to the nearest multiplication of 12.5mg.
16004776|NCT02852681|Drug|15 mg E4/3 mg DRSP|All subjects received both Treatment A and Treatment B either at the first treatment period (Period 1) or the second treatment period (Period 2). Approximately half of the subjects was randomized to receive either Treatment A followed by Treatment B (Sequence AB), or Treatment B followed by Treatment A (Sequence BA)
16004777|NCT02852668|Other|Power Training|This experimental groups underwent an intervention period of power training
16004778|NCT02852668|Other|Strength Training|This experimental groups underwent an intervention period of strength training
16004779|NCT02852655|Drug|MK-3475|
16004780|NCT02852642|Other|Exercise|Plyometric training
16004781|NCT02852629|Other|observational study|
16004782|NCT02852616|Behavioral|Narrative Exposure Therapy|8 - 15 sessions: 1 lifeline session, 5 - 12 sessions narrative exposure, 1-2 sessions of future-oriented counselling
16004783|NCT02852577|Drug|Clonazepam|Administration of clonazepam once a day, flexible dose (0.5 - 2 mg/day), for 36 months. If no remission after 8 weeks augmentation with paroxetine once a day, flexible dose (10 - 40 mg/day), for 34 months.
16004784|NCT02852577|Drug|Paroxetine|Administration of paroxetine once a day, flexible dose (10 - 40 mg/day), for 36 months. If no remission after 8 weeks augmentation with clonazepam once a day, flexible dose (0.5 - 2 mg/day), for 34 months.
16004785|NCT02852564|Drug|Ethacrynic Acid|One oral dose at 50 mg prior to bladder tumor removal surgery
16004786|NCT02852551|Drug|PAT-1251|
16004787|NCT02852551|Drug|Placebo|
16004788|NCT02852538|Behavioral|NEW FED TR|NEW FED TR is a five day treatment for adults with anorexia nervosa. It is a neurobiologically informed, interactive, family-based treatment that draws upon the specific etiological traits characterizing anorexia nervosa. It stands for Neurobiological research findings Enhanced With Family/Friends of those with Eating Disorders, addressing Trait Responses that both create a vulnerability to the illness and serve as markers for recovery through treatment (formerly reported as Temperament-Based Treatment).
16004789|NCT02852525|Device|Confocal laser endomicroscopy (pCLE)|Patients agreeing to participate in the research study will receive an additional intravenous injection during endoscopy. This dose of 2.5 mg of IV fluorescein will be administered during their EGD. Probe-based microscopy will be used to evaluate the mucosa of the esophagus and GE junction
16004869|NCT02851849|Other|Placebo|Placebo QD
16004870|NCT02851836|Behavioral|image visualization and quotation|"two sets of 60 pictures are shown to the adolescents. we ask them to quote for their valence, hedonicity, arousal and to characterize the emotion elicited in each picture.
~This evaluation takes approximately 1hour."
16004790|NCT02852512|Procedure|sacrocolpopexy|Peritoneal incision from the sacral promontory to the Pouch of Douglas. After careful dissection of the inter-rectovaginal space, a two-piece Y-shaped polypropylene mesh was fixed posteriorly to the levator ani muscles using a absorbable suture. The midpoint of the mesh is anchored to the posterior wall of the vagina. The anterior portion of mesh was then introduced and fixed within the intervesico- vaginal space to the anterior/apical vaginal wall with a running suture. The tails of both meshes were fixed to the sacral promontory with a strong non-absorbable polypropylene suture. The peritoneal incision was re- approximated with a running absorbable suture
16004791|NCT02852499|Other|Urine sampling|
16004792|NCT02852499|Other|Carry a GPS and BET|
16004793|NCT02852499|Other|Carry pollution sensor|
16004794|NCT02852499|Other|Sampling at the maternity|
16004795|NCT02852499|Other|Self-questionnaires|
16004796|NCT02852499|Other|Sampling in partum period|Meconium and a strand of hair.
16004797|NCT02852486|Drug|Pioglitazone|30 mg/day, orally, for 3 months, before imatinib discontinuation
16004798|NCT02852486|Other|imatinib discontinuation|imatinib discontinuation after 3 months of pioglitazone
16004799|NCT02852473|Other|Continuous Positive Airway Pressure|CPAP requires subjects to wear a plastic pressurized mask/apparatus, which is connected via a filter and hose to a pump capable of supplying variable pressure (typically on the range of 4-20 cm H2O). The investigators plan to use a full-face mask to prevent subjects from reducing pressure by opening their mouths. If this cannot be tolerated or properly fitted, or is not compatible with the CPAP ventilator, subjects would use a nasal mask only and be asked to keep their mouths closed.
16004800|NCT02852460|Other|rapid recovery|
16004801|NCT02852434|Drug|Lidocaine Gel (2%)|
16004802|NCT02852434|Drug|Lidocaine Paracervical Block (1%)|
16004803|NCT02852421|Procedure|Single injection paravertebral block|"The patients in single injection group will receive single injection paravertebral block at T3-T4 level with 25 ml of 0.5% ropivacaine and four subcutaneous sham injections"
16004804|NCT02852421|Procedure|Multiple injection paravertebral blocks|"Patients in the multiple injection group will receive five injections of paravertebral blocks from T1 to T5 level. 5 ml of 0.5% ropivacaine was injected at each level."
16004805|NCT02852408|Procedure|Laparoscopic cholecystectomy|
16004806|NCT02852395|Drug|JNJ-48816274|Oral dose; dose range of 5 mg up to 250 mg
16004807|NCT02852395|Drug|Placebo|Oral dose; appearance matched to JNJ-48816274
16004808|NCT02852382|Drug|Bupivacaine|In the scalp block and local infiltration arms; bupivacaine %0,5 will be used.
16004809|NCT02852382|Drug|morphine patient controlled analgesia|End of the surgery all of the patients in 3 groups will receive morphine patient controlled analgesia (PCA) including 1mg/ml morphine. The PCA was set to administer a bolus dose of 1 mg on demand with a lockout period of 10 minutes and maximum 25 mg for 4 hours.
16004810|NCT02852369|Behavioral|Task Oriented Treatment|"The intervention administered during each of the training sessions was modeled after the protocol outlined in Winstein et al. (2013) however implementation was in the participant's home setting and involved tasks in the participant's real world.
~The manual entitled, Upper-Extremity Task-Specific Training After Stroke or Disability by Lang and Birkenmeier (2014) was also utilized to give a general overview of task specific training for the upper extremity and to help guide each activity the participant chose to work on."
16004811|NCT02852356|Device|MIRI-TL Incubator|MIRI-TL Timelapse incubator
16004812|NCT02852330|Device|SA16 research software|Software for measurement of voltage tomography intraoperatively.
16004813|NCT02852330|Device|CS19 (1.6.2)|Software for measurement of voltage tomography post-operatively.
16004814|NCT02852291|Behavioral|Parents Make the Difference|10 parent training sessions delivered to groups of caregivers
16004815|NCT02852291|Behavioral|Parents Make the Difference Plus|10 parent training sessions delivered to groups of caregivers, with 3 home visits
16004816|NCT02852278|Other|Web-based Survey|This is a prospective 12-month study of patients with motor neuron disease enrolled in CReATe Connect, an RDCRN Contact Registry.
16004817|NCT02852265|Drug|Etonogestrel contraceptive implant|Place nexplanon
16004818|NCT02852252|Drug|OTL38|Patients will be given imaging agent 2-3 hours before surgery to assist in imaging.
16004819|NCT02852252|Drug|ICG|Patients will be given imaging agent 24 hours before surgery to assist in imaging.
16004820|NCT02852239|Drug|dabrafenib|Single dose dabrafenib 100 mg
16004821|NCT02852226|Other|Pre Exposure Prophylaxis|Uptake will be measured as the proportion of female patients at the LifeLong clinic who are approached that start PrEP after being offered PrEP, the numbers and rate of PrEP discontinuation, the reasons given for PrEP discontinuation (side effects, no longer at risk, fear of stigma, inability to adhere), and drug concentrations. Drug concentrations are monitored using dried blood spots, which have a large dynamic range capable of detecting use of a few pills every month up through daily use. The main measure of PrEP utilization is the proportion of time that PrEP is used effectively among those attempting to use PrEP.
16004822|NCT02852226|Behavioral|Characteristics of women who enroll|The investigators are interested in characterizing the women who decide to take PrEP through this project. Demographic and psychosocial variables will be used to describe the population who enroll. Sexual and behavioral risk profiles of those who decide to initiate PrEP will also be described as part of this study. Demographics of women who uptake PrEP through community partners will also be compared to the demographics of Alameda County women who have incident HIV infection. In addition to demographics and risk behavior, the investigators will also describe the contraceptive use and intentions of women on PrEP towards future pregnancies as these may be important factors driving interest in PrEP among women.
16004823|NCT02852226|Behavioral|referral sources of women who enroll|Process data will capture the outreach efforts made to recruit participants for this study. At the time of baseline visit, the investigators will capture the source of referral for each woman screened, as well as the primary reason for joining the study. Enrollment progress will be carefully tracked against outreach activities to monitor the relationship between outreach efforts and demand generation. This will help to inform future implementation of PrEP among women.
16004871|NCT02851823|Device|Periodontal curettes|
16004872|NCT02851823|Device|Er-YAG+Nd-YAG lasers|
16004873|NCT02851810|Behavioral|oculomotor parameter recording|visual scanning behavior is assessed during visualization of emotional pictures
16004960|NCT02851121|Behavioral|Emotional protocols|
16004825|NCT02852200|Other|SEGAm|
16004826|NCT02852187|Device|SIGNUS MOBIS PEEK Cage|Lumbar Interbody Fusion
16004827|NCT02852187|Device|SIGNUS MOBIS II ST Cage|Lumbar Interbody Fusion
16004828|NCT02852174|Behavioral|Mindfulness meditation training|Mindfulness meditation training
16004829|NCT02852161|Device|Magnet assissted capsule endoscopy|Patients due to have a clinically indicated gastroscopy will be asked to have a MACE procedure on the same day
16004830|NCT02852148|Device|ACTICOAT|ACTICOAT is a silver coated antimicrobial barrier dressing. ACTICOAT dressings consist of three layers: an absorbent inner core of polyester and rayon sandwiched between outer layers of silver coated, low adherent, high density polyethylene mesh.
16004831|NCT02852135|Device|LMA Proseal|After preoxygenation, anaesthesia was induced with propofol, fentanyl and cisatracurium,LMA Proseal was inserted and cuff inflated in each group.
16004832|NCT02852135|Device|LMA Supreme|After preoxygenation, anaesthesia was induced with propofol, fentanyl and cisatracurium ，LMA Supreme was inserted and cuff inflated in each group.
16004833|NCT02852122|Drug|C-11 choline|This is an uncontrolled, open-labeled, non-randomized, prospective study. The study duration is expected to be completed in a period of 2 years. Up to 54 patients with primary prostate cancer and stratified as high risk group (PSA > 20 ng/mL, or Gleason score 8-10, or clinical stage >T2c) would be included.
16004834|NCT02852096|Other|Dual or Multiple Paraffin Blocks|Assessing Her2/Neu Expression in Gastric Cancer With Dual or Multiple Tumor Tissue Paraffin Blocks
16004835|NCT02852096|Other|One Paraffin Blocks|Assessing Her2/Neu Expression in Gastric Cancer With One Tumor Tissue Paraffin Blocks
16004836|NCT02852083|Drug|Pioglitazone|Pioglitazone 25 mg once daily, p.o.
16004837|NCT02852083|Drug|nivolumab|3 mg per kilogram of body weight every 2 weeks, p.o. (standard treatment)
16004838|NCT02852083|Drug|Treosulfan|Treosulfan 250 mg twice daily, p.o.
16004839|NCT02852083|Drug|Clarithromycin|Clarithromycin 250 mg twice daily p.o.
16004840|NCT02852070|Procedure|bronchoalveolar lavage 120ml|120mL sterile saline solution instilled into the distal bronchial tree in 3 times
16004841|NCT02852070|Procedure|bronchoalveolar lavage 60ml|60mL sterile saline solution instilled into the distal bronchial tree in 3 times
16004842|NCT02852057|Drug|timolol maleate and dorzolamide hydrochloride|Timolol maleate and dorzolamide hydrochloride loaded contact lenses
16004843|NCT02852044|Behavioral|Rest|Allowed to watch television or read for one hour prior to oral glucose tolerance test
16004844|NCT02852044|Behavioral|Exercise|One hour of cycling at 50% of maximal power output
16004845|NCT02852044|Other|Dorsal Hand Vein Cannulation (heated hand technique)|
16004846|NCT02852044|Other|Venous Cannulation|
16004847|NCT02852031|Other|Collaborative Learning Network|
16004848|NCT02852018|Genetic|Identification of genetic polymorphisms|
16004849|NCT02852005|Biological|MVA/HIV62B vaccine|1×10^8 TCID50 dose to be administered as a 1 mL intramuscular (IM) injection in the deltoid
16004850|NCT02852005|Biological|AIDSVAX B/E vaccine|600 mcg/mL dose to be administered as a 1 mL IM injection in the deltoid
16004851|NCT02852005|Biological|Placebo|Sodium Chloride for Injection USP, 0.9% to be administered as a 1 mL IM injection in the deltoid
16004852|NCT02851992|Device|GTS cementless stem|Total Hip Arthroplasty
16004853|NCT02851979|Other|Olfactory stimulations|"Odors are disseminated using a portable fragrance device, a prototype developed by a research unit, CNRS UMR5292. The device is outside the incubator, the only part inside is a disposable Teflon tube. The odor flux stimulates distally the NBs' nostrils. Odoriferous compounds are placed in glass tubes. This allows the olfactometer to deliver three distinct odors (to avoid habituation) in a random scheme: spearmint odor, vanilla odor, and grapefruit odor (chemicals registered by Chemical Abstracts Service), while controlling for intensity (amount of compound), duration, and odor sequence. For the vehicle period, the glass tubes remain empty.
~Stimulations occur every 5 minutes, for 5 seconds, they are mixed in medical gas to avoid infection. There are three 24-hour periods, and two 24-hour wash out periods, followed by a maximum of 3 days of surveillance."
16004854|NCT02851966|Procedure|mTESE|mTESE time may be postponed or advanced.
16004855|NCT02851953|Device|Aqueduct-100|
16004856|NCT02851940|Procedure|Rubber Band Ligation|Anoscopic rubber band ligation by bedside with patient in the jack-knife position (equipment: anoscope, rubber band applicator)
16004857|NCT02851940|Procedure|Hypertonic Saline Infusion|Endoscopic retroflexed 3 ml injection of 20% hypertonic saline 1cm above the dentate line (equipment: Flex sig, injection needle, 20% saline)
16004858|NCT02851927|Procedure|Mini Thoracoscopy|Pleural biopsy using rigid mini thoracoscope
16004859|NCT02851927|Procedure|SemiRigid Thoracoscopy|Pleural biopsy using semirigid thoracoscope
16004860|NCT02851914|Drug|"Tricyclic Antidepressants (TCA)"|if patient shows signs of depression they will be placed on one of these medications and seen by a psychiatrist.
16004861|NCT02851914|Drug|"Selective Serotonin Uptake Inhibitors (SSRI)"|if patient shows signs of depression they will be placed on one of these medications and seen by a psychiatrist.
16004862|NCT02851888|Drug|Ropivacaine|Iliac fascia block was performed in the experimental group with a single shot of Ropavicaine.
16004863|NCT02851888|Other|Normal Saline Sham Injection|Sham block using normal saline instead of iliac fascia block but otherwise employing the equivalent technique.
16004864|NCT02851888|Procedure|General Anesthesia|Patients were induced and maintained in a fashion consistent with standard practices.
16004865|NCT02851875|Other|Registry|
16004866|NCT02851849|Drug|LGD-6972-5 mg|5 mg LGD-6972 QD
16004867|NCT02851849|Drug|LGD-6972-10 mg|10 mg LGD-6972 QD
16004868|NCT02851849|Drug|LGD-6972-15 mg|15 mg LGD-6972 QD
16004875|NCT02851810|Behavioral|psychophysiological recording|this consists of the measurement of the skin conductance reactivity (SCR) during the picture visualization
16004876|NCT02851810|Behavioral|psychometric assessment|self administered questionnaires are used to assess anxiety, depression and alexithymia.
16004877|NCT02851810|Behavioral|parent interview|an interview of the adolescent parent is performed in order to assess the confusion of the parent-child role and the interaction between the child and its parent.
16004878|NCT02851797|Drug|givinostat|suspension of givinostat (10 mg/mL)
16004879|NCT02851797|Drug|placebo|suspension manufactured to mimic givinostat
16004880|NCT02851784|Biological|adoptive immunotherapy|HCC (D ≤5 cm, fewer than three tumors) patients were treated with radical MWA and 4-6 courses of immunotherapy with CIK every year.The immunotherapy were started at 2 weeks, 4 weeks, 6 weeks, 10 weeks, 14 weeks, 18 weeks and then every 12 weeks after MWA. Peripheral blood mononuclear cells were differentiated into phenotypically confirmed DCs and effector cells. DC-CIK and CTL were injected into the abdominal cavity. CIK was infused intravenously.
16004881|NCT02851784|Procedure|MWA|ALL the HCC patients will be treated only by microwave ablation and then enter the follow-up
16004882|NCT02851771|Other|Nasopharyngeal Swab|
16004883|NCT02851758|Other|autologous mitochondria transplantation|Autologous mitochondria obtained from the subject's own skeletal muscle will be injected or infused into the ischemic myocardium
16004884|NCT02851745|Drug|Linagliptin|
16004885|NCT02851745|Drug|Placebo|
16004886|NCT02851732|Behavioral|Quality Improvement Intervention|The quality improvement intervention includes case management, reminders, check lists, educational materials, and audit and feedback reports
16004887|NCT02851719|Other|PFMT with biofeedback + Home PFMT|24 outpatient sessions PFMT with biofeedback (twice a week). Simultaneously, it was prescribed a home exercise daily program during three months (supervised treatment).
16004888|NCT02851719|Other|PFMT without biofeedback + Home PFMT|24 outpatient sessions PFMT without biofeedback (twice a week). Simultaneously, it was prescribed a home exercise daily program during three months (supervised treatment).
16004889|NCT02851693|Device|Optical Coherence Tomography (OCT) with Vivosight|OCT used is Vivosight for diagnosis
16004890|NCT02851693|Device|Optical Coherence Tomography (OCT) with Skintell|OCT used is Skintell for diagnosis
16004891|NCT02851680|Biological|blood samples|
16004892|NCT02851667|Behavioral|Resident training programs|A total of 24 resident training programs such as talks, day camp and thematic activities were delivered in the intervention estate by CFSC from June to November 2011. Each program included an introduction to the concepts of Learning Family and family 3Hs as well as how to promote family 3Hs through learning and communicating with family, delivered by interactive games and workshops.
16004893|NCT02851654|Device|Infrared oculography|The infrared oculography provides binocular recordings and allows simultaneous measurement of horizontal and vertical eye movements.
16004894|NCT02851641|Procedure|"pushed mono-canaliculonasal intubation"|
16004895|NCT02851628|Device|Alternative sizing model based trial mask|A trial full face mask to be used for this trial for the treatment of obstructive sleep apnea using CPAP therapy.
16004896|NCT02851628|Device|Prototype Full Face Mask|A prototype full face mask with previous clinical trial experience used for the treatment of obstructive sleep apnea using CPAP therapy.
16004897|NCT02851615|Behavioral|SCThrive Intervention for Adolescents with SCD|Chronic Disease Self-Management Program
16004898|NCT02851602|Biological|Blood sample|
16004899|NCT02851589|Biological|PCAR-019 (anti-CD19 CAR-T cells)|
16004900|NCT02851576|Other|Infusion of ADV specific T cells|Cell engineering
16004901|NCT02851537|Other|an advanced technique as magnetic resonance spectroscopy (MRS)|subjects who had an advanced technique as magnetic resonance spectroscopy (MRS) It is based on the detection of cerebral metabolites, and the variations of their concentration to characterize different pathologies.
16004902|NCT02851524|Other|posturography|
16004903|NCT02851511|Behavioral|Cognitive Training|Cognitive Training employs an eight component, PositScience BrainHQ suite via its researcher portal.
16004904|NCT02851511|Device|tDCS (active stimulation)|A Soterix Clinical Trials Direct Current Stimulator will apply 20 minutes of 2.0mA direct current through two biocarbon rubber electrodes encased in saline soaked 5cm x 7cm sponges (8cc of 0.9% saline solution per sponge) placed over the frontal cortices at F3 and F4 (10-20 system).
16004905|NCT02851511|Device|tDCS (sham stimulation)|Sham stimulation is performed with the same device and all procedures will be identical except for the duration of stimulation. Participants will receive 30 seconds of 2 mA of direct current stimulation at the beginning of the session. Participants habituate to the sensation of tDCS within 30-60 seconds of stimulation. This procedure provides the same sensation of tDCS without the full duration of stimulation, making it a highly effective sham procedure.
16004906|NCT02851511|Behavioral|Educational Training|Educational training involves watching educational videos produced by the National Geographic Channel, which cover a range of topics such as history, nature, and wildlife. Participants will be asked to complete questions on the content of the videos to ensure sustained attention.
16004907|NCT02851498|Other|Food product: high-protein pasta and cereal|
16004908|NCT02851485|Drug|GLPG1972 600 mg oral solution fasted|dosing after overnight fasting
16004909|NCT02851485|Drug|GLPG1972 600 mg oral tablet fasted|dosing after overnight fasting
16004910|NCT02851485|Drug|GLPG1972 600 mg oral tablet fed|dosing after high-fat high-calorie breakfast
16004911|NCT02851472|Drug|Inhaled Nitric Oxide|Nitric oxide gas will be added to the inhaled gas mixture that the patient was already receiving at baseline, using standard of care gas delivery systems adapted specifically for this study.
16004912|NCT02851472|Drug|Placebo|Placebo gas (nitrogen) will be added to the inhaled gas mixture that the patient was already receiving at baseline, using standard of care gas delivery systems specifically adapted for this study.
16004913|NCT02851459|Behavioral|Baseline Survey|The baseline survey contains questions regarding level of existing vaccine hesitancy (Parent Attitudes about Childhood Vaccines (PACV) short scale and HealthStyles questions), demographic information, and intent to vaccinate their children. All study surveys will be completed on an electronic device.
16004956|NCT02851134|Genetic|genetic analysis|genetic (Whole Exome Sequencing )
16004957|NCT02851134|Biological|blood and stools samples|biological collection
16004914|NCT02851459|Behavioral|Pre-intervention Survey|Participants will be contacted two weeks after completing the baseline survey to answer questions about their moral beliefs. The survey will include questions form the Moral Foundations Questionnaire as well as additional questions. An algorithm will calculate the participant's moral matrix based on answers to these questions.
16004915|NCT02851459|Behavioral|Morally Congruent Message|"Intervention messages consist of four short paragraphs. The first three focus on how getting vaccinated helps uphold specific moral foundations. The fourth summarizes the contents of the prior paragraphs.
~Participants randomized to the morally congruent arm will receive a vaccine-related message developed to appeal to their three most-emphasized moral foundations. The first paragraph focuses on the most emphasized foundation, the second on the third-most emphasized, and the third on the second-most emphasized."
16004916|NCT02851459|Behavioral|Morally Non-Congruent Message|"Intervention messages consist of four short paragraphs. The first three focus on how getting vaccinated helps uphold specific moral foundations.
~Participants randomized to the morally non-congruent arm will receive a vaccine-related message developed to appeal to their three least-emphasized moral foundations. The first paragraph focuses on the least emphasized foundation, the second on the third-least emphasized, and the third on the second-least emphasized."
16004917|NCT02851459|Behavioral|Control Message|Participants randomized to the control arm will be provided with a short passage about the costs and benefits of bird feeding.
16004918|NCT02851459|Behavioral|Post-Intervention Survey|Immediately after reading the randomly assigned message participants will complete a follow-up survey assessing level of existing vaccine hesitancy (PACV short scale and HealthStyles questions) and intent to vaccinate their children.
16004919|NCT02851446|Other|measure dyspnoea> Borg 7|
16004920|NCT02851433|Drug|total anaesthesia and postoperative inhaled sedation with Sevoflurane|
16004921|NCT02851433|Drug|total intravenous anaesthesia with Propofol.|
16004922|NCT02851420|Other|spectroscopy|
16004923|NCT02851407|Drug|Defibrotide|
16004924|NCT02851407|Other|Best Supportive Care|
16004925|NCT02851394|Drug|Levobupivacaine|
16004926|NCT02851394|Drug|levobupivacaine|
16004927|NCT02851394|Drug|tramadol|
16004928|NCT02851381|Drug|FG-3019|"The FG-3019 treatment will be administered over a 28-day cycle:
~Dose: 35 mg/kg
~Route: IV over one hour following completion of gemcitabine infusion
~Schedule:
~Days 1, 8, and 15
~Please note that Day 8 infusion will on be completed during the first treatment cycle"
16004929|NCT02851368|Device|near infrared fluorescence imaging (NIFI)|The NIFI system will be evaluated for its ability to 1) visualize nodules and their margins 2) differentiate between benign and malignant nodules and 3) identify additional undiagnosed nodules after receiving an injection of indocyanine green 1 day prior to planned surgery.
16004930|NCT02851368|Drug|Indocyanine Green|Indocyanine Green will be administered intravenously 1 day prior to NIFI.
16004931|NCT02851316|Other|Whole Body Vibration|Participants will stand in a squatted position on a platform that provides a brief vibratory stimuli.
16004932|NCT02851303|Drug|Morphine|Morphine wean protocol as described in arm description
16004933|NCT02851303|Drug|Methadone|Methadone wean protocol as described in arm description
16004934|NCT02851290|Procedure|Caudal block anesthesia|After induction of general anesthesia, a caudal block will be performed using 0.75-1 mL/kg of 0.2% ropivacaine without epinephrine
16004935|NCT02851290|Procedure|Dorsal penile nerve block anesthesia|After induction of general anesthesia, a dorsal penile nerve block will be performed using 0.75-1 mL/kg of 0.2% ropivacaine without epinephrine
16004936|NCT02851277|Drug|ASP0892 Intradermal|Intradermal injection
16004937|NCT02851277|Drug|ASP0892 Intramuscular|Intramuscular injection
16004938|NCT02851277|Drug|Placebo Intradermal|Intradermal injection
16004939|NCT02851277|Drug|Placebo Intramuscular|Intramuscular injection
16004940|NCT02851238|Other|Driving Pressure Limited Ventilation|Positive end expiratory pressure is adjusted to minimize driving pressure, plateau pressure minus end expiratory pressure from 2 to 10 cmH2O during one-lung ventilation
16004941|NCT02851225|Other|telemedicine transmission of biological results|telemedicine transmission of biological informations
16004942|NCT02851212|Drug|Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC]|Participants will receive 1 XR FDC tablet containing canagliflozin 150 mg and metformin 1000 mg orally under fed (Treatment B)or fasted condition (Treatment D) in a given treatment period as per treatment sequence.
16004943|NCT02851212|Drug|Canagliflozin|Participants will receive canagliflozin 150 mg (50 mg+100 mg oral tablets) under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.
16004944|NCT02851212|Drug|Canagliflozin|Participants will receive canagliflozin 100 mg oral tablet under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.
16004945|NCT02851212|Drug|Metformin Extended Release (XR)|Participants will receive metformin XR 500 mg tablet orally under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.
16004946|NCT02851199|Device|Electroencephalography|Electroencephalograph recording following hyperventilation in different participant's body postures
16004947|NCT02851186|Device|Acupuncture|
16004948|NCT02851186|Device|Sham acupuncture|
16004949|NCT02851173|Device|LLLT|The treatment will consist of applying light of a specific wavelength (1064 nm) using a laser diode supplied by Cell Gen Therapeutics, LLC (CG-5000 laser, HD Laser Center, Dallas, TX, USA).
16004950|NCT02851173|Device|Placebo|The treatment will consist of applying light of a specific wavelength (1064 nm) using a laser diode supplied by Cell Gen Therapeutics, LLC (CG-5000 laser, HD Laser Center, Dallas, TX, USA). However, the placebo group will receive approximately 1/12th of the cumulative energy density as the treatment group.
16004951|NCT02851160|Other|semi-structured interview conducted by a clinical psychologist|semi-structured interview conducted by a clinical psychologist
16004952|NCT02851160|Other|semi-structured interview conducted by a psychiatrist specialized in psycho-oncology|semi-structured interview conducted by a psychiatrist specialized in psycho-oncology
16004953|NCT02851147|Device|SL-D301|Slit Lamp
16004954|NCT02851147|Device|DC-4|Digital Camera Attachment
16004955|NCT02851147|Device|SL-3G|Slit Lamp
16005022|NCT02850614|Device|FitBit|
16004961|NCT02851121|Other|Protocol with a spatial dimension|
16004962|NCT02851108|Drug|Methylene Blue|50 patients will receive methylene blue
16004963|NCT02851108|Drug|Primaquine|50 patients will receive primaquine
16004964|NCT02851095|Drug|Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC]|Participants will receive 1 XR FDC tablet containing canagliflozin 50 mg and metformin 1000 mg orally under fed (Treatment B) or fasted (Treatment D) condition in a given treatment period as per treatment sequence.
16004965|NCT02851095|Drug|Canagliflozin|Participants will receive canagliflozin 50 mg oral tablet) under fed (part of treatment A) or fasted (part of treatment C) condition in a given treatment period as per treatment sequence.
16004966|NCT02851095|Drug|Metformin Extended Release (XR)|Participants will receive 2 metformin XR tablets of each 500 mg orally under fed (part of treatment A) or fasted (part of treatment C) condition in a given treatment period as per treatment sequence.
16004967|NCT02851082|Other|Endurance training program|"Exercise intensity will be fixed to the corresponding powers for ventilatory thresholds, if applicable for pain tolerance. The endurance interval training workout is known to induce metabolic and physiological adaptations. For intermittent workout training protocol, recovery periods at moderate intensity between periods at high intensity help to sustain repeated high intensity periods of exercise. If pain disturbs exercise tolerance, power will be lowered as necessary.
~A set of 3 training sessions per week of 45 minutes each for 6 consecutive weeks will be proposed (one session every two days). This scheme is usually encouraged for patients suffering from chronic diseases."
16004968|NCT02851056|Biological|Survivin Vaccine|"Pre-transplant vaccination : The target dose of Survivin+ Dendritic cells (survivin+, CD11c+, Human Leukocyte Antigen - antigen D Related (HLA-DR)+ by flow-cytometry) is 15 x 10^6 cells. A minimum of 1 x 10^6 cells and a maximum of 20 x 10^6 cells will be administered.
~Post-transplant vaccination: The target dose of Survivin+ Dendritic cells (survivin+, CD11c+, HLA-DR+ by flow-cytometry) is 15 x 10^6 cells. A minimum of 1 x 10^6 cells and a maximum of 20 x 10^6 cells will be administered."
16004969|NCT02851056|Procedure|Autologous Hematopoietic Cell Transplantation|The participant's own cells are collected from their blood, frozen, and then given back to them after they receive chemotherapy.
16004970|NCT02851056|Biological|Prevnar 13|13-Valent Pneumococcal Conjugate Vaccine (PCV13, Prevnar13). Co-Immunization: All participants will be co-immunized with Prevnar at each time they receive the survivin vaccine. This vaccine will be administered intramuscular (IM) 0.5cc.
16004971|NCT02851056|Drug|Granulocyte-colony Stimulating Factor|After the first survivin vaccination, participants will be mobilized with G-CSF.
16004972|NCT02851043|Device|pneuRIP (breathing with resistance)|subjects are given a resistance element to breath through
16004973|NCT02851043|Device|Respitrace system (Carefusion) (breathing without resistance)|subjects are asked to breath normally
16004974|NCT02851030|Behavioral|Move, Play, Learn!|Participants will attend a 4 hour workshop at the beginning of the intervention and the midpoint, covering project information, physical activity for young children, and distribution of project materials. Teachers will focus on one area of their child care day for 2 weeks each: indoor structured PA, outdoor structured PA, transitions between activities, and circle time. Participants will receive an email newsletter introducing the topic and will implement short (10 minutes) classroom activities. Teachers will also be educated about teacher PA practices, focusing on 1 behavior during each segment. Research staff will contact the teachers weekly to provide technical assistance, help teachers troubleshoot any issues that participants have with the activities, and provide encouragement.
16004975|NCT02851017|Other|Exercise|This study is designed to examine and comparing there intervention program on postural control, flow and technology acceptance in young healthy adults.
16004976|NCT02851004|Drug|Napabucasin|"1 cycle is 21days.
~BBI608: Oral administration at a dose of 240mg or 480 mg twice daily (BID), every day.
~[Additional cohort to the Phase II part] Oral administration at a dose of 240mg mg BID, every day
~The therapy will be repeated until meeting the discontinuation criteria."
16004977|NCT02851004|Drug|Pembrolizumab|"1 cycle is 21days.
~Pembrolizumab: Administration at a dose of 200 mg/body on Day 1 of each cycle
~[Additional cohort to the Phase II part] Administration at a dose of 200 mg/body on Day 1 of each cycle.
~The therapy will be repeated until meeting the discontinuation criteria."
16004978|NCT02850991|Radiation|High-dose|Drug: concurrent chemotherapy with radiation paclitaxel plus carboplatin are used weekly in both arms
16004979|NCT02850991|Radiation|Standard-dose|Drug: concurrent chemotherapy with radiation paclitaxel plus carboplatin are used weekly in both arms
16004980|NCT02850978|Drug|Spiolto|
16004981|NCT02850965|Drug|BI 695501|
16004982|NCT02850965|Drug|Humira|
16004983|NCT02850952|Other|Rehab MATRIX|Rehab MATRIX is a patient assignment tool that objectively categorizes patients undergoing inpatient rehabilitation based on nurse identified acuity variables.
16004984|NCT02850939|Behavioral|Mobile phone app + patient navigation|The intervention group will receive two components: 1) a culturally sensitive, personalized and easy to use smartphone app; and 2) support from a patient navigator. The intervention is based in Social Cognitive Theory and principles of motivational interviewing - and will feature basic components of individual empowerment, motivation and engagement, including knowledge, attitudes, skills, peer modeling, social support/reinforcement and self-efficacy beliefs and expectations
16004985|NCT02850926|Other|Soccer head gear|Each head gear model consists of lightweight materials with a cross strap design that is fully adjustable or a single elastic headband. All models meet or exceed the American Society for Testing and Materials (ASTM) testing standards for soccer headgear and are approved by the National Federation of High Schools and The Fédération Internationale de Football Association (FIFA) for use by interscholastic soccer players. Players will be allowed to choose the brand of head gear to use and wear it for each practice and game during the soccer season.
16004986|NCT02850913|Drug|Doxycycline|"115 participants will be randomized to either oral Doxycycline 100 mg daily for six weeks.
~Treatment will be initiated in hospital but will be continued at home.
~Scheduled study clinic visits will be made by the participants at 6, 12 and 24 months.
~Each participant will be visited at home at 2, 4 and 6 weeks for adherence monitoring and assessment of safety"
16004987|NCT02850913|Other|Placebo|- Placebo (matching capsules containing no active ingredients)
16004988|NCT02850900|Behavioral|Internet Survey|Weekly survey will be emailed, subjects should complete them
16004989|NCT02850887|Other|general endotracheal anesthesia|sedation with the use of endotracheal intubation
16004990|NCT02850887|Other|deep sedation without endotracheal intubation|deep sedation without endotracheal airway management.
16004991|NCT02850874|Procedure|Hyperthermic intraperitoneal chemotherapy|HIPEC in this study involves the washing of the peritoneal cavity with a heated (40-48°C), (1000 mg/m sq) solution of gemcitabine in 1.5% dextrose for 90 min. Compared with systemic delivery of chemotherapy, intraperitoneal delivery can increase site-specific concentration of chemotherapeutic agents and decrease duration of perfusion, vascular complications, and systemic toxicity. The use of heated chemotherapeutic agents, compared to conventional protocols, has been shown to increase direct cytotoxicity to malignant cells and augment penetration into tumors.
16004992|NCT02850874|Procedure|Open pancreaticoduodenectomy|"Tumors of the pancreatic head will be surgically removed by open PD (standard and pylorus-preserving approaches) with the aim of achieving en bloc R0 tumor resection (no macroscopic residual cancer remaining). In all patients, a lymphadenectomy will be performed along the hepatoduodenal ligament, common hepatic artery, vena cava, and the interaortocaval and right side of the superior mesenteric artery. In cases with portal vein involvement, a venous resection will be performed to achieve R0 resection. Patients with arterial infiltration by the tumor will be deemed locally nonresectable and will be excluded from analysis.
~Established, routine surgical and ERAS protocols will be followed for pre-, intra-, and postoperative care of patients. Patients will be discharged after postoperative day 5 if tolerating oral intake and showing no signs or symptoms of complications."
16004993|NCT02850874|Drug|Gemcitabine|Neoadjuvant and adjuvant systemic chemotherapy will be administered to all PDAC patients with the aim of diminishing the tumor burden and maximizing the chance of complete surgical resection. Gemcitabine (GEMZAR®) will be administered for 6 months (including period of neoadjuvant therapy) according to established institutional guidelines for dosing, frequency, duration, administration route, and setting.
16004994|NCT02850861|Device|Condylar reductor|A new surgical instrument was designed to assist the surgeons to perform condylar fracture reduction.
16004995|NCT02850848|Drug|Entigin Film Coated Tablet 0.5mg|
16004996|NCT02850848|Drug|(Baraclude 0.5mg Tablets|
16004997|NCT02850835|Other|Video Decision Aid|A video decision aid was developed inform patients about pelvic organ prolapse, to include female anatomy, and treatment options.
16004998|NCT02850822|Drug|Demethylation drug|Demethylation drug,such as Decitabine
16004999|NCT02850822|Drug|Chemotherapy regimen|Chemotherapy regimen,such as CAG, G-CSF 5-10ug/kg/day on days 4 and 17；Aclacinomycin 7mg/m2/day on days 4 and 11；Cytarabine 20mg/m2/day on days 4 and 17.
16005000|NCT02850796|Behavioral|Kg-Free|Cognitive-behavioral intervention based on promoting acceptance, mindfulness and self-compassion abilities
16005001|NCT02850796|Other|Treatment as Usual|Standard nutritional treatment that involves dietary and physical activity support provided by the medical units Standard
16005002|NCT02850783|Procedure|89Zr-nanocoll and Indocyanine Green|
16005003|NCT02850770|Behavioral|Pedometers and Walking Logs|Participants were recommended to use the pedometer and walking log to self-monitor how many steps participants walked each day. Participants were recommended to gradually increase daily steps over the course of 12 weeks until reaching 10,000 steps per day. Participants were also recommended to walk at a brisk pace for 3000 of these steps, which roughly translates to 30 minutes per day.
16005004|NCT02850770|Behavioral|Phone Messaging|Participants received short text or voice messages (depending on participant preference) as reminders to review daily step goals and to self-monitor; explaining the benefits of regular physical activity, importance of regular physical activity to daily life, and ways to overcome commonly identified barriers to physical activity; asking participants to report on their physical activity performance; providing feedback based on responses.
16005005|NCT02850770|Behavioral|Family/Friend Support|Participants identified a family member or close friend (FF) to receive short text or voice messages (depending on FF preference) with suggested behaviors that are perceived as supportive by individuals making physical activity behavior changes.
16005006|NCT02850757|Device|U shaped Guedl's airway|To use U shaped Guedl's airway for assisting fiberoptic bronchoscope during endotracheal intubation
16005007|NCT02850757|Device|Modified William's airway|Use Modified William's airway for assisting fiberoptic bronchoscope dduring endo tracheal intubation
16005008|NCT02850744|Drug|PQR309|80mg capsules p.o. once daily and possibly Standard Treatment with temozolomide
16005009|NCT02850731|Device|plate-forme Hu360®|the innovative technology (plate-forme Hu360®) will be used in the experimental arm
16005010|NCT02850718|Drug|Sublingual Sildenafil|50 mg sildenafil sublingual wafer.
16005011|NCT02850718|Drug|Oral Sildenafil|50 mg oral sildenafil (Viagra)
16005012|NCT02850692|Other|measure of endothelial function|Arterial tone index measured by EndoPAT®. Patient should neither eat nor drink at least 4 hours before exam and should neither smoke 3 hours before the exam.
16005013|NCT02850692|Biological|Blood sample|21 ml of blood to measure : hepatic workup, complete blood count (CBC), platelets, prothrombin time (PT), activated partial thromboplastin time (aPTT), C-reactive protein (CRP), lipid test, ionograms, creatinine, tissue plasminogen activator factor (tPA), plasminogen activator inhibitor-1 (PAI-1), tissue factor pathway inhibitor (TFPI), Willebrand factor, soluble thrombomodulin, blood levels of endoglin and syndecan. And level beta human chorionic gonadotropin (beta-HCG) for woman only.
16005014|NCT02850692|Other|Hepatic elastography|Hepatic elastography by Fibrocan®. Patient should neither eat nor drink at least 2 hours before exam. 10 successive measurements are made.
16005015|NCT02850692|Diagnostic Test|Injected abdominal CT|"Patient should neither eat nor drink at least 4 hours before exam.
~The examination is not realized if an abdominal scan or an MRI was performed in the five years prior to the day of the visit."
16005016|NCT02850666|Behavioral|Interdisciplinary process drama|Process drama program (5 days/week, 1 week, 25-3 hour sessions) of movement-based activities combining music, art, and drama. Activities have been planned by a collaborative team of drama teachers, occupational therapists, and speech language pathologists.
16005017|NCT02850653|Biological|PCR : 16S ribosomal DNA and real-time targeted PCR|
16005018|NCT02850653|Biological|Sampling of aqueous humour|
16005019|NCT02850627|Drug|Tongguan capsule|eligible participants were randomized to receive Tongguan capsule ( 1.5 g/day for six months immediately after PCI)
16005020|NCT02850627|Drug|placebo capsule|eligible participants were randomized to receive placebo capsule ( 1.5 g/day for six months immediately after PCI)
16005021|NCT02850614|Behavioral|gaming application to encourage physical activity|
16005023|NCT02850601|Drug|Dexamethasone|Dexamethasone solution 0.5 mg/mL, rinse for 5 minutes and expectorate
16005024|NCT02850588|Procedure|Transcarotid artery revascularization|Direct implantation of a stent into the carotid artery via a surgical incision in the neck combined with blood flow reversal in the carotid artery during stent placement
16005025|NCT02850588|Procedure|Carotid endarterectomy|Removal of carotid atherosclerotic plaque (endarterectomy) via a surgical incision in the neck
16005026|NCT02850575|Device|Mpact Double Mobility cup|
16005027|NCT02850562|Behavioral|Walking|The Walking Arm will walk 5 times per week for at least 10 minutes/day at the start of the study and build to 30 minutes/day by the 3-month time point.
16005028|NCT02850562|Behavioral|Walking + Exercise|The Walking + Exercise Arm will walk 2 times per week for at least 10 minutes/day at the start of the study and build to 30 minutes/day by the 3-month time point and in addition, complete exercises to improve strength and balance on 3 days each week.
16005029|NCT02850549|Other|Procedure: physical therapy and Neck Pain Classification|Physical therapists treated patients in phase one as they usually do and in phase two were trained to follow a neck classification and matched intervention system.
16005031|NCT02850523|Other|Cognitive Behavioural Therapy for Perinatal Anxiety|The treatment consists of cognitive and behavioural strategies for treating anxiety, tailored specifically to a perinatal/postpartum population.
16005032|NCT02850510|Behavioral|Brief Incredible Years parent training|The IY parent training programme (3-8 years) developed by Webster-Stratton at the Parenting Clinic, University of Washington, is a manualised and video-based training programme for parents of young children with conduct problems (Webster-Stratton and Reid, 2003a). Parents assigned to the short IY Basic (S-IY) condition were divided into groups of 10-12 parents. The S-IY was led by two experienced group leaders and parents met weekly for two-hour sessions at a public health care center in the community. The group leaders led discussions regarding central aspects of parenting on the basis of the video vignettes, role play and homework.
16005033|NCT02850497|Device|optical coherence tomography at 6 months|6-month evaluation of malapposition and endothelization with the use of intracoronary optical coherence tomography
16005034|NCT02850484|Drug|Budesonide|Inhaled corticosteroid
16005035|NCT02850484|Drug|Formoterol|Long Acting Beta Agonist (LABA)
16005036|NCT02850471|Device|electroacupuncture|Transcutaneous Electric Acupoint Stimulation which is a device of electroacupuncture was used on patients in TEAS group with the stimulator parameters set as 2/100Hz, 2V, 30min.
16005037|NCT02850458|Device|implant-retained overdentures|patients treated with an implant-retained overdenture in the mandible
16005038|NCT02850445|Drug|Olanzapine|All patients with schizophrenia were under medication treatment at the baseline. Individualized plan of antipsychotic medication for the patients were determined by psychiatrist who were blind to the group allocation. Medications could be changed at any time during the course of the study if the change was clinically warranted, the drug can also be any other antipsychotic medication.
16005039|NCT02850445|Other|Cognitive behavior therapy|Patients with schizophrenia allocated to the Integrated Treatment(IT) group received Cognitive behavioral therapy.
16005040|NCT02850445|Other|Rehabilitation treatment|Rehabilitation treatment include three modules: medication management, symptom management, and social kill training. Patients with schizophrenia allocated to the Integrated Treatment(IT) group received Rehabilitation treatment therapy.
16005041|NCT02850445|Other|Case management|Patients with schizophrenia allocated to the Integrated Treatment(IT) group received Case management.
16005042|NCT02850432|Procedure|Invasive treatment|Endovascular therapy or surgery with medical therapy according to Trans-Atlantic Inter-Society Consensus II scoring system (TASC II)) as described in the main study protocol
16005043|NCT02850432|Other|Conservative treatment|rehabilitation with medical therapy
16005044|NCT02850419|Drug|ThermoDox (Thermally Sensitive Liposomal Doxorubicin)|A dose of 40 mg/m2 will be administered at each cycle for a total of 6 cycles. ThermoDox will be administered in conjunction with hyperthermia.
16005045|NCT02850419|Radiation|Radiation Therapy|A total of 40 Gy in 20 fractions of 2 Gy per fraction will be administered. Up to 66 Gy of radiation therapy can be administered however institutional guidelines should be followed.
16005046|NCT02850419|Device|Superficial Hyperthermia|Thermal dose is an one-hour treatment at a temperature between 40 and 43 degrees Celsius at the target site.
16005047|NCT02850406|Drug|Voxelotor|Part A: Voxelotor will be administered as oral capsules or tablets Part B: Voxelotor will be administered as oral capsules or tablets Part C: Voxelotor will be administered as oral dispersible tablets or powder for oral suspension Part D: Voxelotor will be administered as powder for oral suspension
16005048|NCT02850393|Other|Functional magnetic resonance imaging|
16005049|NCT02850393|Behavioral|behavioral measures|
16005050|NCT02850393|Other|physiological measurements|
16005051|NCT02850380|Other|"FLIP SWITCHES DOWN IN WEIGHTLESSNESS"|"The circular instrument panel that subjects will see into the cylindrical mask consists of one switch surrounded by a luminous ring (left part of the figure below). The switch can be flipped into any direction within the full 360° range. The switch provides no visual cues about down, but the experimenter can add such cues by means of visually polarized labelling displayed on a circular black screen at the center of the panel (right part the figure below)."
16005052|NCT02850367|Dietary Supplement|Nitrate|Subjects will be supplemented orally either acutely or chronically (4-8 weeks) with NO precursors.
16005053|NCT02850367|Dietary Supplement|Nitrate and L-Arginine|Subjects will be supplemented orally either acutely or chronically (4-8 weeks) with NO precursors.
16005054|NCT02850367|Dietary Supplement|Nitrate and L-Citrulline|Subjects will be supplemented orally either acutely or chronically (4-8 weeks) with NO precursors.
16005055|NCT02850367|Dietary Supplement|Placebo|Subjects will be supplemented orally either acutely or chronically (4-8 weeks) with a placebo.
16005056|NCT02850367|Biological|Evaluation of post-ischemic vascular reactivity|After the intake of the supplement. Concentration of hemoglobin (g/mL) in the quadriceps with the device : NIRS system Oxymon, ARTINIS.
16005057|NCT02850367|Biological|Neuromuscular evaluations|After the intake of the supplement. Measure the stretching force in the ankle (N)
16005058|NCT02850354|Other|anti-g maneuvers|investigate the effects of anti-g maneuvers on cardiovascular and respiratory tolerance to the push-pull-effect.
16005059|NCT02850341|Device|Pedometer|Patients receive a pedometer with instructions how to raise their number of daily steps
16005060|NCT02850328|Other|examination of muscle function and MVC in weightlessness|"MVC tested during three different tasks: (1) leg press, (2) plantarflexion and (3) grip strength.
~parameters of muscle function that can be easily implemented in parabolic flight:
~Rate of force development
~Electromyographic activity
~Ultrasound measure: fascicle length and pennation angle of the gastrocnemius medialis muscle
~Superimposed twitch torque (M-waves at rest and V-waves in MVC conditions)
~Maximum voluntary activation capacity (%VA): %VA = (1-[torque superimposed twitch/torque resting twitch])*100%."
16005061|NCT02850315|Device|optimal coherence tomography|
16005062|NCT02850302|Other|PET with FDG|A PET with FDG will be performed before the treatment is started and after 6 cycles of chemotherapy.
16005063|NCT02850302|Other|Tumor exome analysis|A biopsy of the tumor will be performed before the treatment is started and after 6 cycles of chemotherapy. Tumor exome analysis will be performed before treatment is started and after 6 cycles of chemotherapy.
16005064|NCT02850289|Drug|Pegylated interferon (PEG-INF) alfa-2a|Pegylated interferon (PEG-IFN) alfa-2a will be administered as per investigator's discretion and will be in line with the current product monograph.
16005065|NCT02850289|Drug|Ribavirin|Ribavirin will be administered as per investigator's discretion and will be in line with the current product monograph.
16005066|NCT02850276|Drug|Pyridostigmine|
16005067|NCT02850263|Drug|Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)|Anti-VEGF exposure is defined as treatment with intravitreal aflibercept for the treatment of DMO by the patient.according to the prescribing physician.
16005068|NCT02850263|Drug|Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)|Anti-VEGF exposure is defined as treatment with intravitreal aflibercept or another agent [Ophthalmologicals / Antineovascularisation agents (S01LA05)] for the treatment of DMO by the patient.according to the prescribing physician.
16005069|NCT02850263|Drug|Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)|Anti-VEGF exposure is defined as treatment with intravitreal aflibercept or another agent [Ophthalmologicals / Antineovascularisation agents (S01LA05)] for the treatment of DMO by the patient.according to the prescribing physician.
16005070|NCT02850250|Drug|Cefuroxime|Patients selected and treated as per normal pathway of care. Drugs will be prescribed as per standard Alder Hey Policy at the doses defined in the hospital policy Cefuroxime 50mg/kg 8 hourly (12 hourly if less than 7 days of age, or undergoing peritoneal dialysis - maximum 1.5grams per dose)
16005071|NCT02850224|Behavioral|Motivational interviewing to elicit PCO in pediatrics|A motivational interviewing style webinar. Physicians watch the webinar, incorporate communication techniques.
16005072|NCT02850211|Drug|Celecoxib|1 capsule of 200mg Celebrex PO(per oral) twice a day for 14 days
16005073|NCT02850211|Drug|Ibuprofen|1 tablet of 385mg Ibuprofen PO(per oral) twice a day for 14 days
16005074|NCT02850211|Drug|Tramadol|1 tablet of 50mg Tramadol PO(per oral) twice a day for 14 days
16005075|NCT02850198|Device|scalp electroacupuncture|
16005076|NCT02850198|Device|sham scalp electroacupuncture|
16005077|NCT02850185|Device|oxyhydrogen|Hydrogen/oxygen mixed gas inhaled(proportion 2:1),3 L/min . 1 hour each time,twice a day(BID).Test Duration is three months.
16005078|NCT02850185|Device|Oxygen|oxygen inhaled,3 L/min . 1 hour each time,twice a day(BID).Test Duration is three months.
16005079|NCT02850185|Drug|Conventional treatment|Bronchodilator (LABA,LAMA) with or without ICS.Conventional treatment is invariable with which was given to COPD patients in 3 months before the study.
16005080|NCT02850172|Behavioral|Walk, Eat, & Breathe|"Walking exercise: 3 times per week, 20~30 mins per section
~Eat: nutritional assessment and advice weekly
~Inspiratory muscle training: twice every day, 7 days a week, 6~8 weeks before surgery"
16005081|NCT02850159|Device|rTMS and tDCS|Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously
16005082|NCT02850159|Device|rTMS|Patients underwent five consecutive daily sessions of dual-mode NIBS with high-frequency repetitive transcranial magnetic stimulation (rTMS) over the primary motor cortex of the lower leg and sham anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex simultaneously
16005083|NCT02850146|Drug|18F-AV-1451|
16005084|NCT02850133|Other|aerobic exercise training|aerobic exercise training for 36 sessions within 12-16 weeks
16005085|NCT02850120|Procedure|Tension-free vaginal tape (TVT)|Surgical insertion of Tension-free vaginal tape (TVT) polypropylene mesh in the treatment of stress urinary incontinence.
16005086|NCT02850120|Procedure|Trans-obturator tape (TOT)|Surgical insertion of Trans-obturator tape (TOT) polypropylene mesh in the treatment of stress urinary incontinence.
16005087|NCT02850120|Procedure|Suprapubic sling (SS)|Surgical insertion of Suprapubic sling (SS) polypropylene mesh in the treatment of stress urinary incontinence.
16005088|NCT02850107|Device|Medtronic HawkOne® or TurboHawk™|Use of FDA Cleared Directional Atherectomy (DA) Devices. Medtronic HawkOne® Directional Atherectomy System or TurboHawk™ Plaque Excision System. DA followed by DCB will be performed in all enrolled subjects.
16005089|NCT02850107|Device|Medtronic IN.PACT® Admiral® DCB|FDA Approved Drug Coated Balloon (DCB) Technology. Medtronic IN.PACT® Admiral® DCB will be used after DA.
16005090|NCT02850107|Device|Medtronic Spider™ Distal Protection Device (DPD)|It is recommended that the Medtronic Spider™ Distal protection device (DPD) be paired with DA when used in complex, calcified lesions (TurboHawk™ IFU).
16005091|NCT02850107|Device|"Volcano Visions® PV .014 IVUS catheter"|"Lesion IVUS assessment using the Volcano Visions® PV .014 IVUS catheter will be required in all cases."
16005092|NCT02850107|Device|Nitinol Stent Placement|Only FDA approved nitinol stents can be used if provisional stenting is required.
16005130|NCT02849782|Drug|Fampridine|Oral intake of 10 mg twice daily
16005131|NCT02849769|Device|Implant of an MR-conditional Tachy device system|
16005132|NCT02849756|Other|older in intensive care unit|It is an observational study with no intervention.
16005133|NCT02849743|Drug|Syntocinon|The active substance of Syntocinon is a synthetic nonapeptide identical to the posterior pituitary hormone oxytocin.
16005093|NCT02850094|Behavioral|Financial Bonuses|Each participant is eligible to receive $10 per week for increasing their minutes of moderate to vigorous physical activity by 10% from the previous week, or for meeting CDC guidelines of 150 minutes/week. Participants who meet their target minutes of PA every week for one month, three months, or six months receive $15, $25, or $50 bonuses respectively. If all members of a team meet their individual PA goals, each participant's reward is doubled. In total, participants can earn up to $860 if they meet all their goals.
16005094|NCT02850081|Drug|Statin|"Standard of care treatment (one of four):
~Simvastatin (to 40mg without amlodipine)
~Simvastatin (to 20 mg if currently on amlodipine)
~Atorvastatin (to 80mg)
~Rosuvastatin (to 20mg)"
16005095|NCT02850081|Drug|Atorvastatin|"A lipid-lowering agent and for prevention of events associated with cardiovascular disease.
~10 mg or 80 mg capsules"
16005096|NCT02850081|Other|Placebo|A placebo pill will be used for patients that are to maintain their current dose of statins prior to their CEA.
16005097|NCT02850068|Device|Geniculate Artery Embolization|Geniculate artery embolization (GAE) is a new procedure that is being used to reduce pain and disability (resulting from pain, stiffness and difficulty performing daily activities) caused by knee osteoarthritis (OA). Embolization is a procedure where physicians intentionally block the blood vessels to specific areas of the body to prevent blood flow to that region. By doing this, the decrease in blood flow will decrease the size of the area of interest. In this case, the goal is to decrease the size of inflammatory tissue around the knee, resulting in improvement of pain, stiffness and difficulty performing daily activities from OA.
16005098|NCT02850055|Other|Conventional Physiotherapy|"Leaflet care and health habits of the temporomandibular joint.
~Program of cranio-cervical and temporomandibular exercises.
~Massage of the cervical muscles and self care document for home."
16005099|NCT02850055|Other|Specific Manual Therapy|"Leaflet care and health habits of the temporomandibular joint.
~Program of cranio-cervical and temporomandibular exercises.
~Massage of the cervical muscles and self care document for home.
~Specific manual therapy techniques focusing on the temporomandibular joint and temporomandibular muscles."
16005100|NCT02850042|Behavioral|Occupation-based practice (OBP)|
16005101|NCT02850042|Behavioral|Modified-constraint induced therapy (m-CIT)|
16005102|NCT02850029|Other|Observational study, no intervention|
16005103|NCT02850016|Drug|3BNC117|Intravenous Infusion of 3BNC117
16005104|NCT02850016|Drug|Romidepsin|Intravenous Infusion of Romidepsin
16005105|NCT02850003|Drug|IDP-120 Gel|Gel
16005106|NCT02849990|Drug|Abiraterone Acetate|Given PO
16005107|NCT02849990|Drug|Apalutamide|Given PO
16005108|NCT02849990|Drug|Degarelix|Given SC
16005109|NCT02849990|Drug|Indomethacin|Given PO
16005110|NCT02849990|Other|Laboratory Biomarker Analysis|Correlative study
16005111|NCT02849990|Drug|Prednisone|Given PO
16005112|NCT02849951|Drug|LT-02|12-weeks of 1.6 g BID delayed-release phosphatidylcholine (LT-02)
16005113|NCT02849951|Drug|LT-02 Placebo|12-weeks of 0 g BID delayed-release phosphatidylcholine (LT-02) placebo
16005114|NCT02849938|Device|TytoCare Device|Tyto is a handheld, mobile device designed for capture and transmission of ear/throat/skin images and lung/heart auscultations. It may be used to perform non-invasive, medical examinations, either on a patient (by another person, most commonly a family member, or by a medical professional) or self-performed by the patient, for remote review by a medical practitioner. It is suitable for use on patients in both clinical and home environment.
16005115|NCT02849925|Drug|Sealants to arrest microcavitated caries.|Carious lesions will be treated by minimally invasive dentistry by the use of sealants instead of eliminating carious tissues and using conventional restorative materials.
16005116|NCT02849912|Other|questionnaire|
16005117|NCT02849899|Drug|Vildagliptin|"Galvus is prescribed as recommended by the marketing authorization. In adults, the recommended dose of Galvus is 100 mg per day (one tablet in the morning and another in the evening).
~In patients with moderate or severe kidney problems, the recommended dose is 50 mg once daily (one tablet in the morning).
~Patients with creatinine clearance greater than 50 ml/min the vildalgliptin dose will be 100 mg/day. For those whose clearance is less than 50 ml/min, the daily dose is 50 mg. The creatinine clearance will be measured each week.
~The treatment duration will be 3 months, divided into 2 months of complete treatment and one month of cessation treatment with half dose of vildagliptin."
16005118|NCT02849899|Drug|Placebo|The placebo is the same as Galvus (packaging, shape, color, registration) but will contain only excipient. The given dose will also be identical.
16005119|NCT02849886|Drug|T lymphocytes iCASP9 ΔCD19|Intravenous injection of the T lymphocytes armed with the iCASP9 suicide gene
16005120|NCT02849886|Drug|Dimerizer drug AP1903|"AP1903 drug will be administrated at a dose of 0.4 mg/kg by intravenous route in the two following cases:
~Acute Grade ≥II or symptomatic Grade I GvHD justifying systemic immunosuppression therapy;
~Grade ≥3 toxicity attributable to GMC."
16005121|NCT02849873|Drug|IDP-123 Lotion|Lotion
16005122|NCT02849873|Drug|Tazorac Cream|Cream
16005123|NCT02849860|Drug|IDP-121 Lotion|Lotion
16005124|NCT02849834|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|20Hz and Theta Burst stimulation, both at 80% of motor threshold in contralateral intrinsic hand muscles. Five consecutive days of each mode of stimulation, separated by a minimum of 4 weeks. Daily self-monitoring of pain, sleep quality and fatigue by mans of a 10-item questionnaire
16005125|NCT02849821|Other|hypobaric pressure chamber|hypobaric chamber: ascent within 10 minutes, 3 hour exposure to hypoxic conditions simulating an altitude of 4,000 m.a.s.l., afterwards controlled descent under continuous pulsoximetric control
16005126|NCT02849821|Other|Sigmoidoscopy|To retrieve biopsies from the colon during the course of the study 3 sigmoidoscopies were performed. The first sigmoidoscopy was performed 1 day before the stay in the hypobaric chamber. The second sigmoidoscopy was performed directly after the hypobaric chamber and the third sigmoidoscopy was performed 1 week after the hypobaric chamber. During each sigmoidoscopy 6 biopsies were taken with standard size forceps (2.4 mm). One biopsy was analysed by real-time quantitative polymerase chain reaction (PCR), one biopsy was analysed by Western blotting and another biopsy was analysed for gene gene-expression by in situ hybridisation. Two biopsies were analysed by immunohistochemistry (IHC) and one biopsy was stained with hematoxylin and eosin (H&E).
16005127|NCT02849795|Other|bone densitometry|
16005128|NCT02849795|Other|questionnaires|
16005129|NCT02849795|Other|biological analyses|
16005134|NCT02849743|Drug|Placebo (for Syntocinon)|The placebo is identical to the Syntocinon formulation with the exception of the active compound, i.e., without oxytocin.
16005135|NCT02849730|Device|Fentanyl/ropivacaine based Epi-PCA|Fentanyl and ropivacaine was diluted and administered to the patients according to the clinician's determination. The clinician decided dose, infusion rate, bolus dose, lockout time and total amount of drug mixed in the Epi-PCA.
16005136|NCT02849717|Behavioral|Exercise for Cancer Patients|a standardized, daily, home-based, progressive exercise program
16005137|NCT02849704|Drug|Creon36™|Creon36™ delayed-release capsules, a pancreatic enzyme preparation, is an FDA approved medication. Subjects with chronic pancreatitis (CP) will take Creon36™ for nine days, at a daily dose of 72,000 lipase units per meal (two capsules) and 36,000 units per snack (one capsule), with each capsule containing 36,000 lipase units. Subjects will take Creon36™ for three days prior to Visit 2, the day of Visit 2 and then for five days after the visit until they have completed stool collections.
16005138|NCT02849678|Drug|Ropivacaine|0.5% Ropivacaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision. It is the local anesthetic used as the standard drug in paravertebral nerve blocks at our institution. It is also used in other nerve block infusions at our hospital and institutions across the country. It will be used as the standard drug to which lidocaine is compared.
16005139|NCT02849678|Drug|Lidocaine|"Lidocaine will be infused through a catheter placed in the thoracic paravertebral space to block the transmission of pain signals at the level of the spinal nerves from the abdominal incision.
~At a concentration of 0.5%, Lidocaine has been deemed safe to use for peripheral nerve blocks and analgesia. There are several studies to support this as listed in the references. Compared to ropivacaine, lidocaine is shorter-acting, less cardiotoxic, and safer to use."
16005140|NCT02849665|Other|Kangaroo Position|
16005141|NCT02849652|Behavioral|ATTOC Intervention|ATTOC is implemented in a systematic 3-phase process with 10 steps to guide sites through cultural change and implementation of evidence-based practice.
16005142|NCT02849652|Behavioral|UC Intervention|Sites randomized to UC will not receive an organizational intervention to address TUD treatment. To ensure standardization across UC sites, study personnel will provide a 1-day training seminar that will include written materials describing recommended treatments for TUD to UC personnel consistent with established treatment guidelines.
16005143|NCT02849639|Other|Placebo|Participants will receive educational materials, but will not receive MTM.
16005144|NCT02849639|Other|Medication Therapy Management (MTM)|Participants will receive MTM in addition to the educational materials.
16005145|NCT02849639|Drug|Scopolamine patch|At the beginning and end of the study, participants will be asked to use a scopolamine patch. This patch is not being used to prevent motion sickness (as approved by the FDA), but instead is being used to challenge the participant's memory and thinking abilities and determine cognitive reserve.
16005146|NCT02849626|Drug|Perampanel|E2007
16005147|NCT02849613|Other|Adipose Derived Stem Cells|
16005148|NCT02849613|Other|Vehicle media|
16005149|NCT02849587|Drug|cannabis|Participants will smoke a cannabis cigarette ad libitum as per their usual routine
16005150|NCT02849561|Other|Therapeutic hypothermia|With a mattress at 4°C to reach a central temperature at 33,5°C.
16005151|NCT02849561|Device|Synchronized Intermittent Mandatory Ventilation|Constant volume 6 ml/kg
16005152|NCT02849561|Other|Electroencephalography|
16005153|NCT02849561|Device|Pupillary light reflex surveillance|With Neurolight® device.
16005154|NCT02849561|Device|Transcranial Doppler|Monitoring tool for brain hemodynamic evaluation. With Philips HD15 Ultrasound system®.
16005155|NCT02849548|Drug|suvorexant|First in class orexin antagonist approved by the FDA for the treatment of insomnia
16005156|NCT02849548|Other|placebo|Pill with inactive ingredients
16005157|NCT02849535|Behavioral|PRISM care program|PRISM care is a multidisciplinary program that includes sessions with a hospital pharmacist about the oral chemotherapy: information is given to the patient on adverse events occurrence and management, optimizing drug dosage plan, including drug-drug interactions. Physical sessions will be planned at the beginning of month 1, month 2 and month 3 after the inclusion, then telephone interviews of physical sessions will be planned at month 4, month 5 and month 6. During all these sessions and during the final physical session at the end of month 6, data will be recorded for outcomes assessment.
16005158|NCT02849522|Procedure|Prostatic Artery Embolisation|"The aim of PAE for LUTS (due to BPH) is to reduce the blood supply of the prostate gland, causing some of it to undergo necrosis with subsequent shrinkage.
~The procedure is usually performed with the patient under local anaesthetic and sedation. Using a percutaneous transfemoral approach, super-selective catheterisation of small prostatic arteries is carried out using microcatheters. Embolisation involves the introduction of microparticles to block these small prostatic arteries. Embolisation agents include polyvinyl alcohol (PVA), gelatine sponge and other synthetic biocompatible materials.
~NICE published Interventional Procedures Guidance (IPG453) in April 2013. The evidence at the time of assessment was deemed inadequate in quantity and quality. Therefore, the procedure was given a 'Research-only' recommendation."
16005159|NCT02849522|Procedure|TURP|Transurethral resection of the prostate. A cystoscope is passed up the urethra to the prostate, where the surrounding prostate tissue is excised. This is a common operation for benign prostatic hyperplasia (BPH), with around 15,000 procedures performed in the UK per year (NHS Choices). The conventional TURP method of tissue removal utilizes a wire loop with electrical current flowing in one direction (monopolar) through the resectoscope to cut the tissue. Bipolar TURP allows saline irrigation and eliminates the need for an ESU grounding pad thus preventing TUR syndrome and reducing other complications.
16005160|NCT02849522|Procedure|Open prostatectomy|In an open prostatectomy the prostate is accessed through an incision that allows manual manipulation and open visualization through the incision. The most common types of open prostatectomy are retropubic prostatectomy (RP) or transvesical prostatectomy (TVP).
16005206|NCT02849223|Device|Anodal Transcranial Direct Current Stimulation|2 milliamps (mA) of anodal stimulation will be applied to the left dorsal lateral cortex for 20 minutes concurrent with working memory training.
16005207|NCT02849223|Device|Sham stimulation|30 seconds of anodal TDCS stimulation will be applied to the left dorsal lateral cortex concurrent with working memory training
16005610|NCT02846025|Dietary Supplement|Folate and placebo|rich diet aministracao folate and placebo
16005161|NCT02849522|Procedure|Laser prostate surgery|"This surgical method (HoLEP or KTP/Greenlight) utilizes laser energy to remove tissue. With laser prostate surgery a laser fibre inserted via an endoscope is used to transmit laser energy to enucleate (HoLEP) or vaporise (KTP) the tissue. The specific advantages of utilizing laser energy rather than a traditional electrosurgical TURP is a decrease in the relative blood loss, elimination of the risk of TUR syndrome, the ability to treat larger glands, as well as treating patients who are actively being treated with anti-coagulation therapy for unrelated diagnoses."
16005162|NCT02849509|Drug|Pradaxa (dabigatran)|Pradaxa (dabigatran etexilate)110mg or 150mg
16005163|NCT02849509|Drug|Vitamin K antagonist|Vitamin K antagonist or Pradaxa
16005167|NCT02849483|Drug|Ramosetron|Administer 2 ml of normal saline iv before induction. Inject ramosetron 0.3 mg iv at the end of surgery. Add ramosetron 0.6 mg to the iv PCA.
16005168|NCT02849483|Drug|Normal saline|Administer dexamethasone 10 mg iv before induction. Inject 2 ml of normal saline iv at the end of surgery. Add 4 ml of normal saline to the iv PCA.
16005169|NCT02849470|Procedure|Intradermal Injection in hair loss|Comparative Injection of Control (PRP & Acel) in hair loss; 2) Intradermal Injection in hair loss
16005170|NCT02849470|Procedure|Platelet Rich Plasma|Growth factors and cytokines to promote healing and vascular supply
16005171|NCT02849470|Procedure|Adipose Derived Stem/Stromal Cells|Harvesting Adipose Lipoaspirate with Microcannula System
16005172|NCT02849470|Procedure|Stem/Stromal Cellular Isolation (Digestive)|Cell isolation and concentration add back to AD-stem/stromal cells utilizing Centricyte 1000 Protocol
16005173|NCT02849470|Procedure|MatriStem Matrix (ACell) - Current Standard of Care|
16005174|NCT02849470|Procedure|HD-PRP (High Density Platelet Rich Plasma)|
16005175|NCT02849470|Procedure|Emulsified AD-tSVF|
16005176|NCT02849470|Procedure|Emulsified AD-cSVF|Stem/Stromal Cellular Isolate Added Back to Emulsified AD-tSVF
16005177|NCT02849457|Drug|Vigabatrin|Subjects randomized to vigabatrin in Arm A will be treated with vigabatrin 100mg/kg/day until 24 months of age or until they show evidence of clinical seizures or electrographic seizures on video EEG. If electrographic or clinical seizures occur while on study drug, they will transition into the Open label phase of the study (Arm B) and continue to be followed until 36 months of age.
16005178|NCT02849457|Drug|Placebo|Subjects randomized to placebo in Arm A will be treated with matching placebo at 100mg/kg/day until 24 months of age or until they show evidence of clinical seizures or electrographic seizures on video EEG. If electrographic or clinical seizures occur while on study drug, they will transition into the Open label phase of the study (Arm B) and continue to be followed until 36 months of age.
16005179|NCT02849444|Other|Anti-myeloma treatment at physician discretion|non Interventional Study
16005180|NCT02849431|Behavioral|Mindfulness-based intervention|A version of mindfulness-based cognitive therapy that has been adapted for people with a diagnosis of borderline personality disorder. This comprises eight weekly session, each lasting ninety minutes.
16005181|NCT02849418|Drug|GSK1358820|GSK1358820 injection contains botulinum toxin type A (100 U), sodium chloride (0.9 milligrams [mg]), and human serum albumin (0.5 mg). The 30 mL of study drug will be administered as 30 injections each of 1.0 mL, evenly distributed at 30 sites in the detrusor muscle, spaced approximately 1 centimeter (cm) apart. The injection will be administered using cystoscopy and under local anesthesia. General anesthesia may be used excluding neuromuscular blocking agents.
16005182|NCT02849418|Drug|Placebo|Placebo injection contains sodium chloride (0.9 milligrams [mg]); 30 mL of the injection will be injected at 30 sites in the detrusor muscle, spaced approximately 1 centimeter (cm) apart. The injection will be administered using cystoscopy and under local anesthesia. General anesthesia may be used excluding neuromuscular blocking agents
16005183|NCT02849405|Device|MHRC: Metabolic Hyperspectral Retinal Camera|Comparison of hyperspectral signature of retinal arterioles between subjects suffering from arteriosclerosis and healthy control subjects.
16005184|NCT02849392|Other|Pistachio added 20% of kcals to diet|Pistachio added 20% of kcals to diet
16005185|NCT02849379|Device|Cryosurgery|Percutaneous ablation under CT or ultrasound guidance
16005186|NCT02849379|Biological|NK immunotherapy|Each treatment: 8~10 billion cells in all, transfuion in 3 times, i.v.
16005187|NCT02849366|Device|Cryosurgery|Percutaneous ablation under CT or ultrasound guidance
16005188|NCT02849366|Biological|NK immunotherapy|Each treatment: 8-10 billion cells in all, transfuion in 3 times, i.v.
16005189|NCT02849353|Device|Cryosurgery|Percutaneous ablation under CT or ultrasound guidance
16005190|NCT02849353|Biological|NK immunotherapy|Each treatment: 8~10 billion cells in all, transfuion in 3 times, i.v.
16005191|NCT02849340|Device|Cryosurgery|Percutaneous ablation under CT or ultrasound guidance
16005192|NCT02849340|Biological|NK immunotherapy|Each treatment: 8~10 billion cells in all, transfuion in 3 times, i.v.
16005193|NCT02849327|Device|Cryosurgery|Percutaneous ablation under CT or ultrasound guidance
16005194|NCT02849327|Biological|NK immunotherapy|Each treatment: 8~10 billion cells in all, transfuion in 3 times, i.v.
16005195|NCT02849314|Device|Cryosurgery|Percutaneous ablation under CT or ultrasound guidance
16005196|NCT02849314|Biological|NK immunotherapy|Each treatment: 8~10 billion cells in all, transfuion in 3 times, i.v.
16005197|NCT02849301|Device|Arabin cervical pessary|
16005198|NCT02849288|Device|Bigfoot Biomedical Type 1 Diabetes Management System (T1DMS)|Automated Insulin Delivery System
16005199|NCT02849275|Other|Lactose Free 1% Milk|isocaloric study treatment containing lactose free 1% milk consumed once daily over 4-5 weeks as a control.
16005200|NCT02849275|Other|Probiotic Treatment|Probiotic treatment, consumed once daily, over 4-5 weeks.
16005201|NCT02849262|Drug|Omiganan (CLS001) topical gel|
16005202|NCT02849262|Drug|Vehicle topical gel|
16005203|NCT02849249|Biological|allergovac polimerized (100/100)|Patients will recieve a initiation phase plus a mantenaince phase for 3 months of an allergy vaccine.
16005204|NCT02849236|Drug|Ropivacaine (PECS bloc)|"Ropivacaine 3.75mg/mL
~Injection of a local anesthetic between pectoral major and pectoral minor muscles"
16005205|NCT02849236|Drug|Placebo|20 mL saline 0.9%
16071140|NCT02374567|Drug|Clomipramine|
16005208|NCT02849210|Biological|Allergovac depot with Olea europaea pollen extract|Subcutaneous immunotherapy in depot presentation in a rapid dose escalation scheme: 6 weekly increasing dose injections at the initiation phase plus 3 maintenance monthly injections.
16005209|NCT02849197|Procedure|surgery for pilonidal sinus disease|surgical treatment of pilonidal sinus disease via primary closure, Limberg flap0 technique and Modified Limberg flap technique.
16005210|NCT02849184|Drug|suvorexant|Suvorexant (20mg for 64 years or younger; 15mg for 65 years or older) once daily before bedtime.
16005211|NCT02849184|Other|Placebo|Placebo once daily before bedtime.
16005212|NCT02849171|Device|PET scan|
16005213|NCT02849171|Radiation|C-Choline|
16005214|NCT02849158|Other|Biopsy|Rectoscopy with biopsy
16005215|NCT02849145|Biological|Blood sampling|7,5 ml of patient peripherical blood will be collected at each blood sample.
16005216|NCT02849132|Drug|Entecavir|oral entecavir 0.5mg daily for 8 years
16005217|NCT02849119|Procedure|Laparoscopic or robotic partial nephrectomy|Laparoscopic or robotic partial nephrectomy of a small renal masses (T1a) through transperitoneal or retroperitoneal approach
16005218|NCT02849106|Procedure|biopsy to obtain a chemogram|All patients enrolled will have biopsies (on primary tumor or on a metastasis) before treatment in order to obtain a chemogram by ex vivo 3D culture cells
16005219|NCT02849093|Other|Non-invasive OCT imaging|Optical Coherence Tomography (OCT) to capture high resolution cross-sectional images of tissue microstructures using infra-red radiation.
16005220|NCT02849080|Drug|semaglutide|Oral administration once-daily.
16005221|NCT02849080|Drug|sitagliptin|Oral administration once-daily.
16005222|NCT02849067|Other|Group Treatment|Patients in this group will watch a comedy show that will will not exceed 30 minutes. This group will have until five patients.
16005223|NCT02849067|Other|Group Control|patients in this group will watch a documentary that will not exceed 30 minutes. This will have until five patients
16005224|NCT02849054|Device|Measurement of PTPdi|Insertion of pressure transducer catheter to measure gastic and oesophadgeal pressures for calculation of PTPdi
16005225|NCT02849054|Device|TTV at 4ml/kg|Provision of targetted tidal volume of 4ml/kg
16005226|NCT02849054|Device|TTV at 5ml/kg|Provision of targetted tidal volume of 5ml/kg
16005227|NCT02849054|Device|TTV at 6ml/kg|Provision of targetted tidal volume of 6ml/kg
16005228|NCT02849041|Device|medical imaging|Low-dose CT-scanner
16005229|NCT02849041|Biological|Identification of Circulating Tumor Cells|Research of circulating tumor cells in blood
16005230|NCT02849041|Procedure|Psychological Questionnaires|"The procedure of screening test could be stressful. False positive results can cause anxiety and lead to additional costs, as well as increased exposure to radiation and invasive medical examination. Although this is based on some objective results, there is a high probability of adverse psychological effects in case of false positives; so there is cause for concern in the short term anxiety associated with positive results and the use of additional tests during the intervals between screening phases. There is no data related to psychological distress potentially caused by the discovery of circulating tumor cells."
16005231|NCT02849028|Behavioral|sleep disorder|The study is to investigate whether exist the relationship between sleep disorder and circadian rhythm of patients with TBI or not.
16005232|NCT02849015|Device|Cryosurgery|Argon-helium cryosurgical system (percutaneous ablation under CT or ultrasound guidance)
16005233|NCT02849015|Biological|NK immunotherapy|Natural killer cell(each treatment: about 10 billion cells transfusion in 3 times, i.v.)
16005234|NCT02849002|Device|BrainPulse|Jan Medical's BrainPulse measures the brain motion caused by pulsatile blood flow from the cardiac cycle, referred to as the BrainPulse signal. The BrainPulse measures skull acceleration in response to the brain motion using an array of sensors placed on the head.
16005235|NCT02848989|Other|Qigong Mind-Body Exercise|An exercise program that involves gentle movements combined with breathing/relaxation techniques
16005236|NCT02848976|Other|Re-training to effort (RE)|The RE program includes three weekly sessions, supervised individually by a teacher in adapted physical activity, during 1:30, for four weeks, for a total of 12 sessions
16005237|NCT02848963|Drug|Ketamine-propofol mixture|Ratio of Ketamine-propofol mixture will be compare for every groups.
16005238|NCT02848950|Drug|Metformin|Supplementation of the study group with Metformin till the day of pregnancy confirmation
16005239|NCT02848937|Device|Bath with citrate|bath with citrate which allows the equivalence of mass balance (Ca_eq) compared to the concentrate with 3 mM acetate and 1.5 mM of calcium
16005240|NCT02848937|Device|Bath with citrate and Ca_eq|bath with citrate and Ca_eq of concentrate with 3 mM acetate and 1.5 mM of calcium
16005241|NCT02848924|Other|No intervention|
16005242|NCT02848911|Drug|AFM11|Accelerated-titration dose-escalation with 1 patient per dose-level, followed by standard dose-escalation (3 + 3 design), Treatment duration: 2 weeks
16005243|NCT02848898|Device|Equistasi|
16005244|NCT02848898|Other|Placebo|
16005245|NCT02848885|Other|Active TDCS|Participants will receive active tDCS stimulation.
16005246|NCT02848885|Other|Sham TDCS|Participants will receive sham tDCS stimulation
16005247|NCT02848859|Behavioral|Go! to Sleep|This is an online interactive program that delivers cognitive behavioral therapy for insomnia via the internet.
16005248|NCT02848859|Behavioral|General Sleep Education|Providing patients information on healthy sleep and habits to promote healthy sleep.
16005249|NCT02848846|Device|Robotic Hand|"The patients will use the robotic hand for a period of one year that will be divided in 3 different phases. The first phase is the intensive phase where the patient will use the robotic hand from Monday to Friday all days. This phase will last 6 weeks. The second phase is the semi-intensive where the patient will use the robotic hand only two days per week. This phase will last 6 weeks. The third phase is the monitoring where the patient will use the robotic hand only one day per week until the end of the trial.
~During this phases the patient will perform different task requiring the use of the robotic hand."
16005250|NCT02848833|Drug|JARDIANCE 10mg|T2DM with JARDIANCE 10mg
16005251|NCT02848833|Drug|JARDIANCE 25mg|MT2DM with JARDIANCE 25mgax
16005327|NCT02848209|Procedure|TCA 20% Peeling|TCA peel at a concentration of 20% is applied on subcutaneous undermined skin samples for 2 to 4 minutes until even frosting and neutralized at the even frosting Point.
16071141|NCT02374567|Drug|Opipramol|
16005252|NCT02848820|Drug|Augmentin + Gentamicin|Amoxicillin/clavulanic acid (Augmentin) 25/2.5mg 6-hourly (total 100/10 mg/kg daily; maximum 6000/600mg a day) intravenously for 48 hours Oral amoxicillin/clavulanic acid 50/12.5 mg/kg 8-hourly (max 1500/375mg a day) for in total 7 days Gentamicin 7mg/kg once daily for 48 hours
16005253|NCT02848820|Procedure|Appendectomy|Pre-, peri- and postoperative care according to local protocol. No routine postoperative antibiotics
16005254|NCT02848807|Dietary Supplement|NUTRIDRINK Compact Protein|high-energy, high-protein, oral liquid nutritional supplement; dosage: 2x125 ml per day, 7 days per week for 12 weeks (3 months)
16005255|NCT02848794|Drug|Apatinib and Irinotecan|Patients were administered at apatinib (850mg po qd) and irinotecan(125mg/m2 d1,8) intravenously every three weeks for up to 6 cycles.Maintenance apatinib (500mg po qd) was administered until disease progression or unacceptable toxicity.
16005256|NCT02848781|Device|Implantable Cardioverter Defibrillator (ICD)|An ICD is a battery-powered device placed under the skin that keeps track of heart rate. Thin wires connect the ICD to the heart. If an abnormal heart rhythm is detected, the device will deliver an electric shock to restore a normal heartbeat.
16005257|NCT02848781|Procedure|Catheter Ablation|Catheter ablation is a procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats. Destroying this tissue helps restore the heart's regular rhythm.
16005258|NCT02848768|Drug|Sunitinib|
16005259|NCT02848755|Device|Cranial ultrasonography|
16005260|NCT02848742|Device|Dermal Cooling System|Dermal cryotherapy
16005261|NCT02848729|Drug|Oral Acetaminophen|Acetaminophen for oral administration (2 tablets, 500 mg/tablet)
16005262|NCT02848729|Drug|IV Acetaminophen|Acetaminophen for intravenous (IV) administration (1,000 mg/100 mL)
16005263|NCT02848729|Drug|IV Morphine|Morphine for IV administration (0.125 mg/kg)
16005264|NCT02848729|Drug|Placebo Tablets|Placebo tablets matching oral acetaminophen
16005265|NCT02848729|Drug|Saline|Saline placebo matching IV acetaminophen
16005266|NCT02848716|Procedure|Surgery followed with chemoradiation|"Patients with negative paraaortic lymph nodes will be managed with external beam radiotherapy to the pelvis (as defined by the surgical clips applied at the lower limit of the paraaortic node dissection) at a usual dose of 45 Gy. Limited boosts will be indicated individually on clinically involved parametria or pelvic nodes. The external beam radiation therapy will be followed by intracavitary brachytherapy (High Dose Rate (DR), Low DR or Pulse DR) with intent to cure.
~Patients with metastatic disease to paraaortic lymph nodes will receive extended-field external beam radiotherapy followed by intracavitary brachytherapy with intent to cure. Patients who complete both external beam radiation and intracavitary radiotherapy will receive a total dose of 80-90 Gy low-dose equivalent to Point A.
~Concurrent platinum-based chemotherapy (in the 2 sub groups above) will be given with definitive radiation therapy."
16005267|NCT02848716|Radiation|Standard chemoradiation|"patients with negative paraaortic lymph nodes on PET imaging will be managed with external beam radiotherapy to the pelvis at a usual dose of 45 Gy. Limited boosts will be indicated individually on clinically involved parametria or pelvic nodes. The external beam radiation therapy will be followed by intracavitary brachytherapy with intent to cure (HDR, LDR or PDR). Patients who complete both external beam radiation and intracavitary radiotherapy will receive a total dose of 80-90 Gy low-dose equivalent to Point A.
~Concurrent platinum-based chemotherapy will be given with definitive radiation therapy."
16005268|NCT02848716|Radiation|chemoradiation|
16005269|NCT02848703|Device|Magnetic Resonance Imaging (MRI)|
16005270|NCT02848703|Device|phosphorus-31 Magnetic Resonance Spectroscopy|
16005271|NCT02848703|Device|sodium-23 MRI|
16005272|NCT02848690|Behavioral|Educational Intervention|The educational intervention sessions will be conducted face-to-face, one hour-long and with the aim to encourage and motivate the low-sodium diet adherence. The dietitian's approaches will provide individual skills to achieve the goals (sodium restriction), developing changes in behavior and monitoring the progress towards the skills needed to reduce patient's barriers and difficulties for sodium restricted diet adherence.
16005273|NCT02848690|Other|Usual Care Intervention Group|Participants assigned to the control group will have a dietitian consultation receiving general recommendations for hypertension, such as increasing the consumption of fruits and vegetables, reducing salt intake, avoiding processed and high-sodium foods, reducing body weight if BMI> 25Kg/m2 and limiting consumption of alcoholic beverages. They will be provided with an explanatory folder about hypertension. During six months, participants assigned to the control group will be monitored in monthly visits to the dietitian without modifying their usual care
16005274|NCT02848677|Behavioral|Nutritional counseling|Nutritional counseling implemented by a dietitian for a low sodium diet rich in fruits, vegetables, low fat dairy foods, and low in processed foods.
16005275|NCT02848677|Behavioral|usual care|usual care of hypertensive patients.
16005276|NCT02848664|Device|Dysphagia retraining with device|Patients used the device for 60 trials of retraining swallowing at home each day and also had the device turned on throughout the day in automatic mode to intermittently trigger every few minutes to trigger a swallow for saliva control
16005277|NCT02848651|Drug|Atezolizumab|Atezolizumab 1200 mg was administered by intravenous infusion on Day 1 of each 21-day cycle until disease progression, loss of clinical benefit, or unacceptable toxicity (up to a total of 2 years of atezolizumab treatment).
16005278|NCT02848625|Other|Yoga|Yoga and breathing exercises designed for patients with IPF. Sessions will be two times per week for 12 weeks
16005279|NCT02848612|Drug|anticoagulation by unfractionated heparin|anticoagulation by unfractionated heparin
16005280|NCT02848599|Drug|morphine|
16005281|NCT02848599|Drug|levobupivacaine|
16005282|NCT02848586|Other|ECIGS|15 subjects will receive ECIGs and 5 control subjects will continue to smoke their chosen usual brand of combustible cigarettes (UB). Each group will receive either ECIG or UB for a total of 4 weeks and undergo pulmonary and behavioral assessments during this period. A mobile contingency management (mCM) procedure will be used to provide monetary reinforcement for biochemically verified abstinence from combustible cigarettes. Participants in the UB group will also undergo mCM procedures, but contingencies will differ. After 4 weeks, the ECIG group will be allowed to transition back to their chosen combustible cigarette product for an additional 2 weeks with additional pulmonary and behavioral assessments. All subjects will undergo three respiratory assessments in the DCRU.
16005649|NCT02845765|Device|Dynamic Vessel Analyzer (DVA)|
16071142|NCT02374567|Drug|Trimipramine|
16005283|NCT02848586|Behavioral|mobile contingency management (mCM)|"mCM procedures are a novel smoking cessation tool previously used in the field by our colleagues in the Beckham research group. This equipment is part of a procedure called mobile contingency management or mCM. The participant will use a study smartphone to record his/her CO levels and moods at random times of the day and to verify his/her cigarette usage. The mCM program will reward the participant for each CO level and data transmitted to the study team. The study team will provide detailed information and training to allow them to participate in this part of the study."
16005284|NCT02848586|Other|Usual brand|"The usual brand of cigarettes is the control group in this study. 5 participants will be allowed to continue using their usual brand of combustible cigarette in this arm of the study."
16005285|NCT02848560|Drug|Hyperpolarized Xenon|Inhaled contrast for MRI occurring at each of 4 visits.
16005286|NCT02848547|Behavioral|Text Messaging via Short Message Service|
16005287|NCT02848534|Biological|neutrophil to lymphocyte ratio|value of the neutrophil to lymphocyte ratio in the diagnosis of bacterial infections
16005288|NCT02848508|Drug|Metformin|
16005289|NCT02848495|Genetic|Non-Interventional|
16005290|NCT02848482|Device|Photodynamic therapy|Photodynamic therapy (HELBO Photodynaimc Systems GmbH, Wels, Austria)
16005291|NCT02848482|Procedure|Mechanical debridement|Plastic scalers (Have implantrecallset, Kerr, Italy) will be used to curette the contaminated sites.
16005292|NCT02848482|Drug|Irrigation|0.2% chlorhexidine digluconate solution (Bioworld, Madision, US) will be irrigated at contaminated sites for 1 minute.
16005293|NCT02848469|Dietary Supplement|1000mg of eicosapentaenoic acid and 1000mg docosahexaenoic acid|
16005294|NCT02848456|Procedure|Spinal Manipulation|Manual, side-posture, high-velocity low-amplitude spinal manipulation targeting the lower lumbar spine and sacroiliac joints
16005295|NCT02848456|Procedure|Max Voluntary Isometric Contraction|A 10 second plantar flexion maximal voluntary isometric contraction
16005296|NCT02848456|Procedure|SM+MVIC|The spinal manipulation immediately preceding the maximal voluntary isometric contraction
16005297|NCT02848443|Drug|Trifluridine/tipiracil hydrochloride (S 95005)|Film-coated tablets containing 15mg of trifluridine and 7.065mg of tipiracil hydrochloride, or 20mg of trifluridine and 9.42mg of tipiracil hydrochloride, given orally at the dose of 25 or 30 or 35 mg/m2/dose, until unacceptable toxicity according to the investigator, disease progression or patient withdrawal.
16005298|NCT02848443|Drug|Oxaliplatin|Concentrate for solution for infusion containing 5mg/ml of oxaliplatin, administered intravenously at the dose of 65 to 85 mg/m2, until unacceptable toxicity according to the investigator, disease progression or patient withdrawal.
16005299|NCT02848443|Drug|Bevacizumab|Concentrate for solution for infusion containing 25mg/ml of bevacizumab, administered intravenously at the dose of 5 mg/kg, until unacceptable toxicity according to the investigator, disease progression or patient withdrawal.
16005300|NCT02848443|Drug|Nivolumab|Concentrate for solution for infusion containing 10mg/ml of nivolumab, administered intravenously at the dose of 3 mg/kg, until unacceptable toxicity according to the investigator, disease progression or patient withdrawal.
16005301|NCT02848430|Dietary Supplement|Humulus lupulus|Extract of spent hops standardized to xanthohumol, isoxanthohumol, 6-prenylnaringenin, and 8-prenylnaringenin
16005302|NCT02848417|Drug|Curcumin|Perform a randomized phase I/II study comparing curcumin (increased bioavailable form, body cell mass-85, 400 mg twice a day) to glutathione (liposomal bioavailable form 630 mg bid), with a 3 month intervention and assessment of safety, efficacy and biomarker response to therapy.
16005303|NCT02848417|Drug|Glutathione|Perform dynamic modeling studies before and after 3 months of therapy, repeating the method used previously in order to compare the response to exercise across groups and better quantify the degree of recovery in treated subjects using an exercise challenge and 9 point in time blood and saliva collections over 24 hours with genomic, cytokine, neuropeptide and cell population studies.
16005304|NCT02848417|Other|Placebo|"Placebo liquid 120 ml per/ bottle
~Placebo capsules 60 capsules per bottle 400 mg /cap
~With the addition of a Partner PI, redox/methylation expert Dr. Richard Deth, perform studies of antioxidant and methylation-related metabolic status prior to, during and after acute exercise in GWI subjects before and after interventions."
16005305|NCT02848404|Device|Categorical Language Fluency Smartphone Application|4 weeks' training
16005306|NCT02848391|Other|Environmental|hypobaric flight simulation
16005307|NCT02848365|Device|Endotracheal intubation|Endotracheal intubation will be done with any of these equipments
16005308|NCT02848352|Other|Placebo nasal spray|
16005309|NCT02848352|Other|Film Sequence|
16005310|NCT02848339|Drug|aspirin|aspirin desensitization
16005311|NCT02848326|Drug|Atogepant|Atogepant capsule.
16005312|NCT02848326|Drug|Placebo-matching Atogepant|Placebo-matching atogepant capsule.
16005313|NCT02848313|Drug|Elamipretide|40 mg dose of elamipretide administered once daily as a 1.0mL SC injection.
16005314|NCT02848300|Drug|Bimatoprost 1% Formulation A|Bimatoprost 1% Formulation A solution applied to the scalp and trunk once daily for 14 days.
16005315|NCT02848300|Drug|Bimatoprost 1% Formulation B|Bimatoprost 1% Formulation B solution applied to the scalp and trunk once daily for 14 days.
16005316|NCT02848287|Drug|normal saline|1*2 gauze is soaked with 5 cc of 0.9 % normal saline, applied in tonsillar fossae for 3 min, then removed.
16005317|NCT02848287|Drug|ropivacaine|1*2 gauze is soaked with 5 cc of 0.75% ropivacaine, applied in tonsillar fossae for 3 min, then removed.
16005318|NCT02848261|Behavioral|Developmental Demands|Education and training related to use of CGM in this age group
16005319|NCT02848261|Behavioral|Distress Reduction|Education and training on reducing distress
16005320|NCT02848261|Behavioral|Remote Monitoring|Education and training on the use of remote monitoring
16005321|NCT02848261|Behavioral|Fear of Hypoglycemia|Education and training on reducing fear of hypoglycemia
16005322|NCT02848261|Behavioral|No intervention|No intervention - serves as the control group
16005323|NCT02848248|Drug|SGN-CD123A|Intravenous infusion in 3-week cycles
16005324|NCT02848235|Other|Standard of Care + EMMA|Mother Mentors will provide enhanced care, above that of the standard of care, to include clinic visit exit discussions, visit reminder messages, and patient follow-up in the event that a clinic visit is missed.
16005325|NCT02848222|Device|Bruder Moist Heat Compress|
16005326|NCT02848222|Other|Washcloth|
16005328|NCT02848209|Procedure|Phenol/croton oil Peeling|Phenol/croton oil is applied on subcutaneous undermined skin samples and occluded with silicone tape for 24 hours and not neutralized.
16005329|NCT02848209|Procedure|TCA 40% Peeling|TCA peel at a concentration of 40% is applied on subcutaneous undermined skin samples for 2 to 4 minutes until even frosting and neutralized at the even frosting Point.
16005330|NCT02848196|Radiation|Stereotactic Body Radiation Therapy|The schedule will be 3 fractions of 15 Gy up to a total dose of 45 Gy delivered every day with VMAT and Flattening filter-free (FFF) beams. Image-guided systems, including CBCT, will be used for all patients.
16005331|NCT02848183|Drug|Cytarabine|
16005332|NCT02848183|Drug|Idarubicin|
16005333|NCT02848183|Drug|Mitoxantrone|
16005334|NCT02848183|Drug|Etoposide|
16005335|NCT02848183|Procedure|Hematopoietic stem cell transplantation|
16005336|NCT02848170|Drug|CS-3150|CS-3150 2.5mg, oral
16005337|NCT02848170|Drug|olmesartan medoxomil|olmesartan medoxomil 10 mg, oral
16005338|NCT02848157|Drug|Dexmedetomidine|Patients are put in lithotomy position. Two separate injection points are marked at 3 and 9 o'clock, about 2 to 2.5 cm from the center of anus. After aseptic preparation, a nerve stimulator needle advanced 1.5 to 3.5 cm perpendicular to the skin, and stimulation current is 2.5 to 5 mA. The unilateral contraction of anal sphincter means the inferior anal nerve stimulation. After reducing the current to 0.5 mA, the needle is then moved deeper until an up-and-down penile movement is observed. This is stimulation of the perineal branch of the pudendal nerve. Prepared drug (0.25% ropivacaine and 0.3 mcg/kg dexmedetomidine in the experimental group, and equivalent doses of ropivacaine and normal saline in the control group) is injected in half and half bilaterally.
16005339|NCT02848157|Drug|plain ropivacaine|ropivacaine and normal saline equivalent doses of dexmedetomidine
16005340|NCT02848157|Drug|Ropivacaine|
16005341|NCT02848144|Other|blood samples|
16005342|NCT02848144|Other|Collection of nosocomial infections|
16005343|NCT02848131|Drug|Group 2: Dasatinib|Dasatinib - take one 100 mg tablet by mouth once daily for 3 consecutive days.
16005344|NCT02848131|Drug|Group 2: Quercetin|Quercetin - take four 250 mg capsules daily (total 1000 mg daily) for 3 consecutive days.
16005345|NCT02848118|Device|A nasal-oral cannula of capnography|After propofol infusion, the complete induction is defined when capnography shows hypoventilation and bronchoscope is then introduced to patients.
16005346|NCT02848118|Other|Observer Assessment of Alertness and Sedation scale|After propofol infusion, the complete induction is defined when OAAS is 3 to 2 (conscious sedation) and bronchoscope is then introduced to patients.
16005347|NCT02848105|Drug|VPA|Valproic acid with 1000mg loading dose with 500mg q12 4 hours later to maintain a trough level above 75ug/ml
16005348|NCT02848092|Behavioral|FOCAL+|Weekly for 5 weeks, teens complete a computer training program designed to train teens to limit the length of glances away from the roadway. On a computer, the top portion of the screen plays a simulated video drive while the bottom half of the screen contains a map. Teens complete tasks that require switching between the 2 halves of the screen. While doing so, they receive feedback regarding how long they are looking away from the driving portion of the screen. After each session of computerized FOCAL training, teens will complete two 5-minute simulated drives. During the drives, teens will be cued to a complete a visual search task which will require them to divert their gaze from the road. Eye tracking goggles will monitor eye glances and provide real time auditory feedback when a visual glance away from the roadway exceeds 2 secs.
16005349|NCT02848092|Other|Rules of The road|Weekly for 5 weeks, teens will perform computer-based training regarding traffic codes, laws, and rules of the road. After each computerized training, teens will complete two 5-minute drives. This time in the driving simulator will be contextualized as a time for them to practice the rules of the road they learned during training. Importantly, teens in the sham intervention group will complete the same distraction tasks but will NOT receive any feedback regarding their eye gaze during simulated driving.
16005350|NCT02848079|Drug|combined TAS-102 and TAS-OX|Combination treatment with TAS-102 and oxaliplatin. TAS-102 is an oral medication; oxaliplatin (TAS-OX) is given by infusion.
16005351|NCT02848066|Procedure|Blood sample(10cc) collection|In both groups, serum haptoglobins to be collected and analyzed
16005352|NCT02848053|Other|no intervention|
16005353|NCT02848040|Other|IDK Bile Acids|colourimetric in-vitro laboratory diagnostic test
16005354|NCT02848027|Biological|Regenexx SD® procedure|Correlate patient outcomes 6 months after receiving the Regenexx SD procedure with measurements of synovial fluid collected before and after procedure.
16005355|NCT02848014|Behavioral|Writing task|
16005357|NCT02847988|Device|Neuromuscular electrical Stimulation (NMES)|Electrical stimulation of lower extremities will be applied using an electrotherapy stimulator device (Vectra® Neo). The intensity of stimulation will be titrated based on maximal tolerable muscle contraction
16005358|NCT02847988|Device|Sham Stimulation|Sham stimulation of lower extremities will be applied using an electrotherapy stimulator device (Vectra® Neo).
16005359|NCT02847975|Dietary Supplement|Sodium nitrate|Sodium nitrate will be ingested orally
16005360|NCT02847962|Other|Corn Soy Blend Plus (CSB+)|
16005361|NCT02847962|Other|Corn Soy Blend 14 (CSB14)|
16005362|NCT02847962|Other|White Sorghum Cowpea Blend Variety 1|
16005363|NCT02847962|Other|White Sorghum Cowpea Blend Variety 2|
16005364|NCT02847962|Other|Red Sorghum Cowpea Blend|
16005365|NCT02847962|Other|White Sorghum Soy Blend|
16005366|NCT02847949|Biological|IGN002|IGN002 is a monoclonal antibody fusion protein
16005367|NCT02847936|Procedure|vicryl plus suture|episiotomy with triclosan-coated sutures
16005368|NCT02847936|Procedure|vicryl suture|episiotomy with non antibacterial coated suture
16005369|NCT02847923|Other|Presentation of alternative communication application|At this stage the purpose of the application is submitted, what its purpose and its features in a brief and clear manner.
16005370|NCT02847923|Other|Familiarization with the software interface|At this stage, the volunteer will be asked to use the application by himself for a short time so that he can get acquainted and learn to use it
16005476|NCT02847091|Drug|Insulin|Patients are receiving insulin therapy from at least 12 weeks before Visit 1 (is allowed ±10% dose modification if clinically needed, and is reduced within a 20% to 40% range at Visit 1 and then is controlled up to Visit 8 based on criteria of this study).
16005371|NCT02847923|Other|Test of the software|"Then, the volunteer is instructed to use the application following a script task that will expose a simple and fast way all the application features. These tasks have easy actions to be executed, for example: The user must communicate through the application the phrase I want to drink water, so that he will be instructed to perform the actions to select the option and then drink the water option."
16005372|NCT02847923|Other|Answer the questionnaire|After performing all the tasks the user replies to a questionnaire to evaluate the usability of the application after you use.
16005373|NCT02847910|Procedure|the disposable tissue suction set|Induced abortion is a main backstop for terminating unwanted pregnancies, however, traditional hard metal instruments has lots of insufficiencies such as easily tissue damage, and repeatedly sterilization increases the incidence of cross infection in the hospital what leads to more complications of pelvic inflammation, infertility and so on. Therefore disposable non-metallic instruments are desperately needed as a way to decrease the complications and provide better medical services to patients. So, the investigators want to explore the clinical effect of disposable tissue suction tube set and make comparison with traditional metal instruments.
16005374|NCT02847910|Procedure|traditional metal instruments of abortion|Induced abortion is a main backstop for terminating unwanted pregnancies. In Chinese hospital, traditional metal instruments are always used during the surgery. So the investigators want to explore the clinical effect of disposable tissue suction tube set and make comparison with traditional metal instruments.
16005375|NCT02847897|Device|CO2 AcuPulse Laser|Each subject will receive 3 treatments 4 weeks apart and 3 Follow Up visits, at 1, 3, and 6 months following the last treatment.
16005376|NCT02847884|Biological|Infliximab|Patients will be prescribed Infliximab as a standard of care regardless of study participation.
16005377|NCT02847871|Behavioral|PRISME-3P program|"PRISM-3P program will consist on a visit in the geriatric centre:
~Consultation with the geriatrician to rule a condition associated with loss of mobility and not known until now.
~Perform a nutritional assessment by a dietician followed by appropriate care management.
~Educational activity based on exercises and physical activity and balance: MAPA teaches exercises to develop strength and balance; gives tips to increase time spent on non-sedentary activities and enhance endurance followed by a monthly phone coaching.
~At 3 months, in case of no improvement of the SPPB score of 1 point, a training of 10 weeks with two sessions per week will be perform by the MAPA individually or in small patients groups;
~Implementation of a information exchange processing (mail, phone and book binding) between the various stakeholders."
16005378|NCT02847858|Behavioral|Health-E You: a computer-based intervention to improve the use of effective contraception among Hispanic adolescents|School-based health centers which were randomized into the intervention arm will use the Health-E You App (n=7 clinics).
16005379|NCT02847845|Dietary Supplement|red ginseng powder capsule|usage : 3C bid ac 30min dose : total 3g for 1day drug administration : oral administration administration session : 6weeks
16005380|NCT02847845|Dietary Supplement|Placebo|Control (Placebo) : red ginseng powder capsule(placebo) usage : 3C bid ac 30min dose : total 3g for 1day drug administration : oral administration administration session : 6weeks
16005381|NCT02847832|Other|Standardized transvaginal ultrasound examination|
16005382|NCT02847819|Device|airway ultrasound for vocal cords movement assessment.|Glottic aperture will be scanned using 7.5 megahertz (MHz) linear transducer portable ultrasound machine. after getting the best acoustic window, true, false vocal cords arytenoid movements will be visualized. Individual cord will be focused and doppler velocity will be measured for both the cords.
16005383|NCT02847806|Biological|Estradiol (Insulin sensitivity)|
16005384|NCT02847806|Biological|Testosterone (Insulin sensitivity)|
16005385|NCT02847793|Behavioral|Gaze training|Participants are required to maintain their gaze in a given picture (e.g., a happy face), for a given time (i.e., 750ms vs 1500 ms) to advance to the next trial. (A total of 576 trials will be distributed in a 2-day intervention).
16005386|NCT02847793|Behavioral|Placebo intervention|Participants are exposed to the same amount of time to the experimental stimuli used in the experimental group but there is no contingency between participants' gaze patterns and the end of each of the 576 trials.
16005387|NCT02847780|Device|Active Comparator :C-Mac Videolaryngoscope|Real time assessment of Glottic aperture at the time of extubation by videolaryngoscope
16005388|NCT02847780|Device|Experimental: Airway ultrasound,|Airway ultrasound using portable ultrasound machine to assess vocal cords movement.
16005389|NCT02847767|Procedure|Perfusion Imaging|IV contrast perfusion CT will be performed at baseline and at 1 week after completing treatment. Perfusion imaging is similar to a diagnostic CT except a smaller region is serially imaged post contrast injection with multiple data acquisitions and high temporal resolution
16005390|NCT02847754|Other|Isometric resistance training|"Exercises in the all-fours position Exercises in the swimming Position Exercises in the forearm support Position Exercises with elastic rubber band"
16005391|NCT02847741|Other|patient's routine care|Interview by psychiatrists, questionnaires, blood analysis
16005392|NCT02847715|Device|ePRIME|ePRIME is an remote monitoring pathway that includes an online system for patients to self-report symptoms and AE following cancer treatments. ePRIME allows AE reporting from home and enables patient reported data to be integrated into existing EPR to allow for the reports to be used in routine care. In addition the system is capable of generating alerts for serious symptoms to the relevant clinical team and providing patient advice on managing mild and moderate symptoms.
16005393|NCT02847702|Drug|VM902A 200-mg Capsules|Taken orally with food twice daily
16005394|NCT02847702|Drug|VM902A 400-mg Capsules|Taken orally with food twice daily
16005395|NCT02847702|Drug|Naproxen 500-mg Capsules|Taken orally with food twice daily
16005396|NCT02847702|Drug|Placebo|Capsules to match VM902A and/or naproxen taken orally with food twice daily
16005397|NCT02847689|Behavioral|Language Treatment|Recording of a mother's voice reading a children's storybook.
16005398|NCT02847689|Behavioral|Control Treatment|Standard of Care
16005399|NCT02847676|Procedure|Tissue sample donation|Patients undergo planned gynaecological surgery. Tissue samples, which are routinely taken, are donated.
16005477|NCT02847078|Device|smart phone app|App for this study is provided with real time updating educational materials, reminder, and consultation for improving secondary prevention, and the related information is pushed to a patient in chronological order after his or her PCI operation.
16005650|NCT02845765|Drug|Phosphodiesterase type 5 Inhibitor (PDE5I)|
16005400|NCT02847663|Device|Kryosauna Space Cabin|The whole body cryotherapy device is able to generatue temperatures up to -195°C for 3 minutes. In this study, we generate temperatures of -135°C for 2 minutes as proposed in the manual. The participant will enter the cabin in cold-resistant shoes and will remain in standing position during the whole procedure. The cold temperature is generated by vaporization of liquid nitrogen.
16005401|NCT02847663|Other|cold water tub|The tub will be filled with cold water up to the sternal level of the participants. Adding ice will ensure a constant temperature. The participant will sit inside the tub during the whole procedure.
16005402|NCT02847650|Drug|Placebo|
16005403|NCT02847650|Drug|PF-06649751|
16005404|NCT02847637|Drug|Emicizumab|Participants will receive emicizumab prophylaxis at the specified dose subcutaneously. Upon implementation of protocol version 4, treatment duration will be extended. During this study prolongation, each participant may choose a preferred emicizumab dosing regimen among those permitted and continue on that dosing regimen until discontinuation from the study (up to 6 years).
16005405|NCT02847624|Drug|tolvaptan|
16005406|NCT02847611|Device|Dynamometer LABIN|LABIN is a prototype of dynamometer containing a handle of metal strength, connected with a sensor of pressure registering(recording) the applied strength and transmitting the data in a computer showing an IT curve of the strength according to time.
16005407|NCT02847598|Drug|BIIB059|Administered as specified in the treatment arm.
16005408|NCT02847598|Drug|Placebo|Administered as specified in the treatment arm.
16005409|NCT02847585|Dietary Supplement|Water-soluble Ubiquinol|10 mg/kg BW/d, by oral drops
16005410|NCT02847572|Procedure|Cataract Surgery|All patients wil be having intraocular lens surgery
16005411|NCT02847559|Biological|Bevacizumab|Given IV
16005412|NCT02847559|Procedure|Electric Field Therapy|Undergo electric field therapy using Optune device
16005413|NCT02847559|Device|NovoTTF-200A Device|Undergo electric field therapy using Optune device
16005414|NCT02847559|Procedure|Quality-of-Life Assessment|Ancillary studies
16005415|NCT02847546|Device|True™ Flow Valvuloplasty Perfusion Catheter|Balloon Aortic Valvuloplasty as preparation step in implantation of a Tanscatheter Aortic Valve Implantation (TAVI).
16005416|NCT02847533|Procedure|blood sample|blood sample for concentration levels of inflammatory markers
16005417|NCT02847533|Behavioral|psychometric scales|Mini international interview MADRS, C-SSRS, QIDS-SR, BIS-10, BDHI, BART, ERD
16005418|NCT02847520|Behavioral|Canadian Index Excessive Game|self-administered questionnaire Canadian Index Excessive Game
16005419|NCT02847494|Drug|metoclopramide|metoclopramide 10mg intravenous infusion over 15 minutes
16005420|NCT02847494|Drug|Dexamethasone|dexamethasone 10mg intramuscular injection
16005421|NCT02847494|Drug|methylprednisolone acetate|methylprednislone acetate 160mg intramuscular injection
16005422|NCT02847481|Procedure|fecal microbiota transplantation|fecal microbiota transplantation
16005423|NCT02847481|Drug|placebo fecal microbiota transplantation|placebo fecal microbiota transplantation
16005424|NCT02847481|Procedure|FMT with antibiotic pre-treatment (v1)|FMT with antibiotic pre-treatment (v1)
16005425|NCT02847481|Procedure|FMT with antibiotic pre-treatment (v2)|FMT with antibiotic pre-treatment (v2)
16005426|NCT02847468|Other|FDG Positron Emission Tomography|Subject will performed Positrons Emission tomography (PET) with 18F-Fluorocholine (FDG) before treatment with Sorafenib is started and 1 month after treatment started.
16005427|NCT02847468|Other|FCH Positron Emission Tomography|Subject will performed Positrons Emission tomography (PET) with 18F-Fluorocholine (FCH) before treatment with Sorafenib is started and 1 month after treatment started.
16005428|NCT02847455|Drug|5 mg ilaprazole|One 5-mg ilaprazole tablet (Livzon Pharm Group Inc., China) together with three placebo tablets and one placebo capsule in a package being taken orally each
16005429|NCT02847455|Drug|10 mg ilaprazole|Two 5-mg ilaprazole tablets (Livzon Pharm Group Inc., China) together with two placebo tablets and one placebo capsule in a package being taken orally each morning on an empty stomach for 4 weeks
16005430|NCT02847455|Drug|10 mg Rabeprazole|one 10-mg Rabeprazole tablets together with one placebo capsule in a package being taken orally each morning on an empty stomach for 4 weeks
16005431|NCT02847442|Drug|BIA 9-1067|Opicapone (BIA 9-1067) 50 mg hard capsules. Oral administration, once daily at bedtime, at least one hour before or after the last daily dose of L-dopa/DDCI.
16005432|NCT02847442|Drug|levodopa/dopa decarboxylase inhibitor|OPC enhances the effects of L-dopa. Hence, it may be necessary to reduce the subject's L-dopa/DDCI dose within the first days or weeks of OPC treatment by extending the dosing intervals and/or reducing the amount of L-dopa/DDCI per dose
16005433|NCT02847429|Drug|Crenolanib|
16005434|NCT02847429|Drug|Placebo|
16005435|NCT02847416|Device|BreatheMAX breathing device|
16005436|NCT02847403|Drug|Exenatide|Patients will be injected subcutaneously 2 mg long-acting exenatide once-weekly. No dose titration is foreseen.
16005437|NCT02847403|Other|placebo|patients will be seen at the Center for Cognitive Disorders and Dementia according to their usual schedule.
16005438|NCT02847390|Other|Education intervention|The investigators will develop and deliver a diabetes physician and nursing inpatient diabetes superuser educational curriculum focused on delivering safe, evidence-based diabetes care in the hospital setting. The physician educational curriculum will consist of 10 case-based modules taught to internal medicine residents at two academic hospitals and taught to hospitalists at two academic hospitals and one community hospital. The nursing educational curriculum will consistent of 12 case-based modules taught to unit-based nurses at two academic hospitals and one community hospital. These educational interventions will be delivered over a 6-month time frame from August 2016-April 2017.
16005439|NCT02847377|Other|Injection of [18F]-ODS2004436 radiotracer|
16005440|NCT02847364|Dietary Supplement|chewing gum|The patient will chew one piece (1.45g) of regular chewing gum starting morning of post-operative day 1 for 30 minutes each time, three times per day, till the first bowel movement.
16005478|NCT02847078|Device|A guideline booklet|A guideline booklet with general advice on secondary prevention of coronary artery disease.
16005479|NCT02847052|Other|Non interventional study|
16005480|NCT02847039|Genetic|Blood samples|Blood samples at baseline.
16005509|NCT02846857|Drug|Insulin|Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)
16005441|NCT02847351|Dietary Supplement|Arabinoxylan Diet|"19 free-living subjects (16 F/ 3M) attending from one year the Outpatient Obesity Clinic Policlinico S. Matteo were enrolled. All subjects were already reached weight loss and were in a sort of weight steady state. Based on 7-day food diary, a nutritionist composed 19 isocaloric diets, replacing all consumed carbohydrates with normal or AX crackers. The mean carbohydrates intake was 189.5g, with total fiber 20.6g. In AX diet total fiber was 25.3g/day (20.6 plus 4.68g of AX).
~Height, weight, waist circumference were obtained at time 0, at week 4 and 8. At every time were collected blood samples for glucose, insulin, total cholesterol, HDL-chol., tryglicerides, plasma acyl and des-acyl ghrelin. Glucose and insulin were , also collected 2 h after a 75 g oral glucose tolerance test (OGTT)."
16005442|NCT02847338|Drug|Amlodipine|Amlodipine 5mg and Amlodipine 10mg will be one of the treatments in which patients will receive on the monotherapy arm and on the dual therapy arm.
16005443|NCT02847338|Drug|Lisinopril|"Lisinopril 10mg and Lisinopril 20mg will be one of the treatments in which patients will receive on the monotherapy arm.
~Lisinopril 20mg will be one of the treatments in which patients will receive on the dual therapy arm."
16005444|NCT02847338|Drug|Amiloride|Amiloride 10mg will be one of the treatments in which patients will receive on the dual therapy arm.
16005445|NCT02847338|Drug|Chlortalidone|Chlortalidone 25mg will be one of the treatments in which patients will receive on the dual therapy arm and monotherapy arm.
16005446|NCT02847325|Drug|AC0058TA|50 mg AC0058TA 100 mg AC0058TA 200 mg AC0058TA 400 mg AC0058TA
16005447|NCT02847325|Drug|Placebo capsules|Placebo capsules
16005448|NCT02847312|Other|High avenanthramide, phenolic acid|High avenanthramide and high phenolic acid, matched with energy and insoluable fibre.
16005449|NCT02847312|Other|Low avenanthramide, medium phenolic acid|Low avenanthramide and moderate phenolic acid, matched with energy and insoluable fibre.
16005450|NCT02847312|Other|Control|Control are matched with energy and insoluable fibre.
16005451|NCT02847299|Device|"increase of cough peak flow (Astral ventilator)"|instrumental increase of cough peak flow with a ventilator by hyper-insufflation and with air stacking method
16005452|NCT02847286|Drug|Dapivirine Ring-004|Treatment A: Dapivirine Ring-004 for 28 days
16005453|NCT02847286|Drug|Dapivirine Ring-004 for 28 days along with clotrimazole|Treatment B: Dapivirine Ring-004 for 28 days along with clotrimazole, 5 g per day for 7 days
16005454|NCT02847286|Drug|Clotrimazole|Treatment C: Clotrimazole, 5 g per day for 7 days
16005455|NCT02847260|Drug|Remodulin|Treatment will be initiated whilst hospitalized at approximately 2.0 ng/kg/min with dose increments of 1- 2 ng/kg/min approximately every 12 hours according to clinical response and tolerability. Following subject discharge, the dose rate is increased by 1-2 ng/kg/min with dose increments separated by at least 24 hours. When a dose rate of 20 ng/kg/min is achieved dose increments can be increased at a rate of up to 4 ng/kg/min with dose increments separated by at least 24 hours depending on tolerability. The aim is to achieve a dose rate of at least 10, 20 and 30 ng/kg/min by the end of weeks 1, 4 and 12, respectively and a dose rate by the end of week 16 that achieves pre-defined treatment goals subject to clinical response and tolerability.
16005456|NCT02847247|Drug|CCRE|Endotoxin challenge: Subjects will undergo inhalation of 20,000 EU CCRE. The CCRE will be inhaled by subjects as a nebulized preparation using an ultrasonic nebulizer until the challenge solution is completely spent (generally 10 minutes).
16005457|NCT02847208|Other|self-report written questionnaire|The questionnaire was filled-in by the patients in presence of a clinical nurse. The gynaecological healthcare options and contraceptive choices were recorded. All following questions were closed-ended (answer yes/no): use of contraception; use of contraceptive pill; use of contraceptive implant; use of intrauterine device; use of tubal sterilization; use of mechanical contraception; use of other type of contraception; previous delivery (term pregnancy); gynaecological follow-up; previous Pap smear. In case of a positive answer to one of these questions, more details were requested (depending on the situation: name of the contraception, date of delivery, frequency of the gynaecological follow-up, date of the last pap smear). An internal validation of the questionnaire was performed on a subgroup of patients.
16005458|NCT02847195|Device|pupillometry|This is a safe and painless examination (the device is simply placed on the orbit of the eye). The optical pupillometer is cleaned by doctors before and after each use, using cleaning wipes containing antibacterial, antiviral and antifungal drugs; such wipes are already in use in the service for cleaning equipment.
16005459|NCT02847182|Biological|Cord Blood Infusion|
16005460|NCT02847182|Biological|Placebo|
16005461|NCT02847169|Device|filcon IV1 toric lens|toric contact lens
16005462|NCT02847169|Device|ocufilcon D toric lens|toric contact lens
16005463|NCT02847156|Other|Physical assessment|1 year follow-up in CF infants with clinical, microbiological and therapeutic assessments
16005464|NCT02847143|Drug|nasal oxytocin or placebo|nasal administration of oxytocin or palcebo 45 min befor fMRI session
16005465|NCT02847143|Device|fMRI|FMRI during emotional image visualization
16005466|NCT02847143|Behavioral|Attachement scale interview (ASI)|this scale is used to determine the attachement style of each participant
16005467|NCT02847143|Behavioral|psychometric scales|self adminstrated questionnaires which asses the level of anxiety (Spielberger State-trait anxiety interview-STAI), depression (Beck depression inventory-BDI) and alexithymia (Toronta Alexuthymia scale-TAS 20)
16005468|NCT02847130|Other|Informational Intervention|Participate in focus group
16005469|NCT02847130|Other|Interview|Undergo one-on-one interviews
16005470|NCT02847130|Other|Medical Chart Review|Review of medical chart
16005471|NCT02847130|Other|Questionnaire Administration|Ancillary studies
16005472|NCT02847117|Other|Mastiha|The volunteers will follow a low-phytochemical diet for five days, meaning that they will exclude fruits, vegetables, legumes, coffee, tea, alcoholic beverages and chocolate. On the day of the experiment and after overnight fasting, the volunteers will consume 10g of natural Mastiha and blood samples will be obtained on timepoints 0h, 30min, 1h, 2h, 4h, 6h and 24h after Mastiha intake. Until timepoint 6h, will be allowed to consume only water. Urine samples will also be collected on timepoints 0h, 4h, 8h and 24h.
16005473|NCT02847104|Other|dynamic insulin protocol|Adaptation of insulin infusion rate according to hourly capillary blood glucose and dynamic insulin protocol
16005474|NCT02847104|Other|static insulin protocol|Adaptation of insulin infusion rate according to hourly capillary blood glucose and static insulin protocol
16005475|NCT02847091|Drug|Ipragliflozin|Oral administration, 50mg once daily
16005481|NCT02847026|Biological|IPV at 14 and 22 weeks of age, Rotarix|Participants in this arm will receive a full dose of inactivated poliovirus vaccine (IPV) at 14 weeks of age and a full dose IPV booster at 22 weeks of age. They will also receive the rotavirus vaccine, Rotarix, at 6 and 10 weeks of age.
16005482|NCT02847026|Biological|IPV at 14 and 22 weeks of age, RotaTeq|Participants in this arm will receive a full dose of inactivated poliovirus vaccine (IPV) at 14 weeks of age and a full dose IPV booster at 22 weeks of age. They will also receive the rotavirus vaccine, RotaTeq, at 6, 10, and 14 weeks of age.
16005483|NCT02847026|Biological|IPV at 14 and fIPV at 22 weeks, Rotarix|Participants in this arm will receive a full dose of inactivated poliovirus vaccine (IPV) at 14 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. They will also receive the rotavirus vaccine, Rotarix, at 6 and 10 weeks of age.
16005484|NCT02847026|Biological|IPV at 14 and fIPV at 22 weeks, RotaTeq|Participants in this arm will receive a full dose of inactivated poliovirus vaccine (IPV) at 14 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. They will also receive the rotavirus vaccine, RotaTeq, at 6, 10, and 14 weeks of age.
16005485|NCT02847026|Biological|IPV at 6 and fIPV at 22 weeks, Rotarix|Participants in this arm will receive a full dose of inactivated poliovirus vaccine (IPV) at 6 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. They will also receive the rotavirus vaccine, Rotarix, at 6 and 10 weeks of age.
16005486|NCT02847026|Biological|IPV at 6 and fIPV at 22 weeks, RotaTeq|Participants in this arm will receive a full dose of inactivated poliovirus vaccine (IPV) at 6 weeks of age and a fractional dose IPV (fIPV) booster at 22 weeks of age. They will also receive the rotavirus vaccine, RotaTeq, at 6, 10, and 14 weeks of age.
16005487|NCT02847026|Biological|fIPV at 6-14-22 weeks of age, Rotarix|Participants in this arm will receive a fractional doses of inactivated poliovirus vaccine (fIPV) at 6 and 14 weeks of age and a fIPV booster at 22 weeks of age. They will also receive the rotavirus vaccine, Rotarix, at 6 and 10 weeks of age.
16005488|NCT02847026|Biological|fIPV at 6-14-22 weeks of age, RotaTeq|Participants in this arm will receive a fractional doses of inactivated poliovirus vaccine (fIPV) at 6 and 14 weeks of age and a fIPV booster at 22 weeks of age. They will also receive the rotavirus vaccine, RotaTeq, at 6, 10, and 14 weeks of age.
16005489|NCT02847013|Drug|TAP block w Liposomal bupivacaine|TAP block w Liposomal bupivacaine diluted to 0.66% (20 mLs)
16005490|NCT02847013|Procedure|TAP block w normal saline|TAP block w normal saline -preservative free 0.9% sodium chloride (20mLs)
16005491|NCT02847000|Drug|Tetrahydrouridine|"Starting dose is by weight:
~THU is supplied as 250 mg/capsule Weight 40-60kg = 2 capsules of Tetrahydrouridine. Weight 61-80kg = 3 capsules of THU. Weight 81-100kg or higher = 4 capsules of THU.
~Timing between THU and Dec, Frequency of administration: Oral THU capsules followed 60 minutes later by oral Dec capsules are ingested 2X/week on consecutive days. Treatment on protocol monitoring continues for 52 weeks, however, subjects will have the option to continue beyond this period if it judged to be in their interests."
16005492|NCT02847000|Drug|Decitabine|"Starting dose is by weight:
~DEC is supplied as 5 mg/capsule. Weight 40-60kg = 2 capsules of Decitabine. DEC capsules are ingested ~60 minutes after THU capsules. Weight 61-80kg = 3 capsules of DEC. DEC capsules are ingested ~60 minutes after THU capsules. Weight 81-100kg or higher = 4 capsules of DEC. DEC capsules are ingested ~60 minutes after THU capsules.
~Timing between THU and Dec, Frequency of administration: Oral THU capsules followed 60 minutes later by oral Dec capsules are ingested 2X/week on consecutive days. Treatment on protocol monitoring continues for 52 weeks, however, subjects will have the option to continue beyond this period if it judged to be in their interests."
16005493|NCT02846987|Drug|Abemaciclib|
16005494|NCT02846974|Device|Pulse oximeter|A pulse oximeter will be used for calibration
16005495|NCT02846948|Other|Focused assessed echocardiography|Focused assessed transthoracic echocardiography is non-invasive, painless procedure. The transducer is placed on the chest at certain locations and angles to get the required information on patient's condition.
16005496|NCT02846935|Drug|Decitabine|2-4 capsules depending on the weight of participant. Dec capsules are ingested ~60 minutes after THU capsules.
16005497|NCT02846935|Drug|Tetrahydrouridine|2-4 capsules depending on the weight of participant. Oral THU capsules followed 60 minutes later by oral Dec capsules are ingested 2X/week on consecutive days.
16005498|NCT02846909|Drug|Progesterone|400mg progesterone pessaries
16005499|NCT02846883|Biological|MSC's|Intravenous infusion of 1 million allogeneic MSCs/kg.
16005500|NCT02846883|Biological|MSC's|Intravenous infusion of 3 million allogeneic MSCs/kg
16005501|NCT02846883|Drug|Placebo|Intravenous infusion of Plasmalyte A (placebo)
16005502|NCT02846870|Other|Visually enhanced prostate cancer educational presentation|Receive visually enhanced prostate cancer educational presentation
16005503|NCT02846870|Other|Standard prostate cancer education presentation|Receive standard prostate cancer education presentation
16005504|NCT02846857|Other|15-week intervention with sensor-augmented pump|A sensor will be inserted on the day before the start of the intervention by the participant. The participant will also have to install the study insulin pump. Participants will be advised to continue with study intervention at home for the next 15 weeks. Participants will have been previously shown how to use the study insulin pump.
16005505|NCT02846857|Other|15-week intervention with single-hormone closed-loop|A sensor will be inserted on the day before the start of the intervention by the participant. On the first day of the intervention, participants will be admitted to the clinical research facility anytime between 8:00 am and 11:30 am. Training on connection and disconnection of the system, meal boluses, etc. will be given. Only participants demonstrating competency on use of study devices will be allowed to continue to the home study phase. Participants will be advised to continue with study intervention at home for the next 15 weeks.
16005506|NCT02846857|Other|15-week intervention with dual-hormone closed-loop|A sensor will be inserted on the day before the start of the intervention by the participant. On the first day of the intervention, participants will be admitted to the clinical research facility anytime between 8:00 am and 11:30 am. Training on connection and disconnection of the system, meal boluses, etc. will be given. Only participants demonstrating competency on use of study devices will be allowed to continue to the home study phase. Participants will be advised to continue with study intervention at home for the next 15 weeks. Participants will have to reconstitute glucagon everyday.
16005507|NCT02846857|Device|Insulin pump|MiniMed® Paradigm® Veo™, Medtronic
16005508|NCT02846857|Device|Continuous glucose monitoring system|Enlite sensor®, Medtronic
16005510|NCT02846857|Drug|Glucagon|Glucagon (Eli Lilly) will be used during dual-hormone closed-loop strategy.
16005511|NCT02846831|Other|12-day intervention with sensor-augmented pump therapy|"A sensor will be inserted on the day before the start of the intervention by the participants. The participant will also have to install the study insulin pump. Participants will be advised to continue with study intervention at home for the next 12 days.
~Participants will have been previously shown how to use the study insulin pump."
16005512|NCT02846831|Other|12-day intervention with single-hormone closed-loop strategy|"A sensor will be inserted on the day before the start of the intervention by the participants. On the first day of the intervention, participants will be admitted to the clinical research facility anytime between 8:00 am and 11:30 am. Training on connection and disconnection of the system, meal boluses, etc. will be given.
~Only participants demonstrating competency on use of study devices will be allowed to continue to the home study phase. Participants will be advised to continue with study intervention at home for the next 12 days."
16005513|NCT02846831|Device|Insulin pump|Tandem Diabetes Care
16005514|NCT02846831|Device|Continuous glucose monitoring system|Dexcom G5 Platinum
16005515|NCT02846831|Drug|Insulin|Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)
16005516|NCT02846818|Procedure|Microdialysis|Extracerebral MD catheters were positioned in a retrograde direction in the internal jugular vein.
16005517|NCT02846805|Procedure|implant-retained overdentures|subjects will receive two-implant-retained overdentures in the mandible,and they continue wearing their complete denture in the maxilla.
16005518|NCT02846792|Biological|Nivolumab|Given IV
16005519|NCT02846792|Drug|Plinabulin|Given IV
16005520|NCT02846779|Other|Low intensity|Low intensity telepharmacy outreach
16005521|NCT02846779|Other|Moderate intensity|Moderate intensity telepharmacy outreach
16005522|NCT02846779|Other|High intensity|High intensity telepharmacy outreach
16005523|NCT02846766|Drug|Lenvatinib|Lenvatinib is administered orally at a starting dose of 24 mg per day. Lenvatinib is administered in cycles of 28 days.
16005524|NCT02846753|Procedure|trans catheter heart valve replacement|trans catheter heart valve replacement
16005525|NCT02846740|Device|Alpha-Stim®.|cranial electrical stimulation
16005526|NCT02846740|Behavioral|Montgomery-Åsberg Depression Rating Scale, Hamilton Anxiety Rating Scale, The Pittsburgh Sleep Quality Index and agitated behavior Scale|A summed global score from rating scales measuring the Modifiable suicide risk factors (MSRF's).
16005527|NCT02846727|Device|skin perfusion image|Upon enrollment following written, informed consent, the patient will receive an injection of 7.5 mg of Indocyanine Green (ICG) intravenously (Dilute 25 mg of Indocyanine Green (ICG) with 10 cc of solvent to achieve a 2.5 mg/cc concentration.) Following injection, Novadaq's LUNA™ fluorescence angiography system will be utilized to map a standard skin perfusion image (SPI) over the upper extremities and anterior chest wall.
16005528|NCT02846714|Behavioral|FLARE|
16005529|NCT02846701|Drug|duloxetine|The concentration of duloxetine is measured by liquid chromatography coupled to tandem mass spectrometry on blood sample
16005530|NCT02846675|Biological|autologous SVF|SVF will be obtained from lipoaspirates of subjects which will contain more than 5 millions nucleated cells.
16005531|NCT02846675|Biological|Placebo|a Placebo treatment without SVF cells
16005532|NCT02846662|Behavioral|CONEMO|The study intervention has two components: the smartphone application CONEMO and primary care nurses monitoring patients' adherence to the intervention. CONEMO is a 6-week low-intensity behavior activation program delivered in 18 sessions that include messages related to the treatment goals, motivating them to do certain activities, helping to select and plan activities and messages related to psychological skills that facilitate the incorporation of activities in everyday life and to tackle obstacles that hinder patients to be more active. Primary care nurses are responsible for training participants to use the CONEMO app, monitoring patients' adherence to CONEMO, calling patients when they are non-adherent, and giving technical support when necessary.
16005533|NCT02846649|Behavioral|PIER|Daily text message queries with tailored support
16005534|NCT02846623|Drug|Atezolizumab|Given IV
16005535|NCT02846623|Other|Laboratory Biomarker Analysis|Correlative studies
16005536|NCT02846623|Biological|Obinutuzumab|Given IV
16005537|NCT02846623|Drug|Venetoclax|Given PO
16005538|NCT02846597|Procedure|Sustained lung inflation in preterms (SLI).|Providing a positive pulmonary ventilation with an opening lung pressure for the first breath of preterm infant for a sustained period of time
16005539|NCT02846584|Biological|CD19 or CD20 CAR T cells briging HSCT|Patients will receive a one-week regimen of chemotherapy consisting of fluid arabise and cyclophosphamide aimed to deplete the lymphocytes. One week later, patients are intravenously infused autologous anti-CD19 or anti-CD20 CAR T cells.
16005540|NCT02846571|Biological|Human Pancreatic Islet Transplantation|Human Pancreatic Islet Transplantation in the Eye Anterior Chamber of legally blind Type 1 Diabetic Patients with or without a Stable Prior Kidney Transplant
16005541|NCT02846558|Other|Frequent Patient Interaction|Weekly informational and supportive text messages will be sent to patients, encouraging adherence to the calorie restriction diet.
16005542|NCT02846558|Behavioral|Timing Restriction|Patients continue to follow their normal diet, but limit food intake to an 8-hour period during the day.
16005543|NCT02846558|Device|LoseIt! Smartphone Application|Patients will be trained by study staff to download the LoseIt! application, and use it to log all food intake throughout the study duration. Data collected from the application will be the primary measure of adherence to dietary changes.
16005544|NCT02846545|Biological|Golimumab|Participants will receive subcutaneous golimumab intermittently for 52 weeks in double-blind period, where doses will be based on weight and/or body surface area. Participants meeting response criteria at Week 52, may receive golimumab SC for 50 weeks (doses will be based on weight and/or body surface area) in an OL extension period.
16005545|NCT02846545|Biological|Placebo|Matching Placebo to golimumab.
16005546|NCT02846532|Drug|Rivaroxaban|Participants will receive oral suspension containing rivaroxaban 1 milligram per milliliter (mg/ml) twice daily in Part A and Part B. Following total daily doses of Rivaroxaban will be administered based on the weight of the participants: 7 to <8 kilogram (kg) will receive 2.2 milligram (mg); 8 to <10 kg will receive 3.2 mg; 10 to<12 kg will receive 3.4 mg; 12 to <20 will receive 4.0 mg and 20 to <30 will receive 5.0 mg.
16005547|NCT02846532|Drug|Acetylsalicylic Acid|Participants will receive 5 milligram per kilogram (mg/kg) of acetylsalicylic acid once daily up to 12 months in Part B.
16005548|NCT02846519|Drug|Esketamine|100-mcL spray of 14% esketamine solution (14 mg) for a total dose of 56 mg.
16005549|NCT02846519|Drug|Rifampin|2 capsules (300 mg each) of rifampin.
16005550|NCT02846506|Drug|Canagliflozin and Metformin Extended Release (XR) Fixed Dose Combination [FDC]|Participants will receive 1 XR FDC tablet containing canagliflozin 150 mg and metformin 500 mg orally under fed (Treatment B)or fasted condition (Treatment D) in a given treatment period as per treatment sequence.
16005551|NCT02846506|Drug|Canagliflozin 50 mg|Participants will receive canagliflozin 50 mg oral tablet under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.
16005552|NCT02846506|Drug|Canagliflozin 100 mg|Participants will receive canagliflozin 100 mg oral tablet under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.
16005553|NCT02846506|Drug|Metformin Extended Release (XR)|Participants will receive metformin XR 500 mg tablet orally under fed (part of Treatment A) or fasted condition (part of Treatment C) in a given treatment period as per treatment sequence.
16005554|NCT02846493|Drug|bromocriptine|Patients in this group will receive rectal bromocriptine at a daily dose of 2.5 mg for 7 days,from the day of oocyte pickup.At oocyte retrieval and at the 3rd d and 5th d of treatment, all the patients received the measurements of body mass index (BMI), abdominal circumference (AC), maximum depth of ascites in ultrasonic (D),hepatorenal function, coagulation function ,white blood cell count (WBC), hematocrit (HCT), Vascular Endothelial Growth Factor(VEGF),drink intake (Intake) and urine volume.
16005555|NCT02846493|Drug|dexamethasone|Patients in this group will take oral dexamethasone at a daily dose of 3mg for 7 days,from the day of oocyte pickup.At oocyte retrieval and at the 3rd d and 5th d of treatment, all the patients received the measurements of body mass index (BMI), abdominal circumference (AC), maximum depth of ascites in ultrasonic (D),hepatorenal function, coagulation function ,white blood cell count (WBC), hematocrit (HCT),Vascular Endothelial Growth Factor(VEGF), drink intake (Intake) and urine volume.
16005556|NCT02846480|Other|physical therapy|"Pre-surgical Physical Therapy: physical therapy aimed to correct the posture, to the awareness and the strengthening of the pelvic floor muscles.
~Post-surgical Physical Therapy: checking the correct contraction of the pelvic floor muscles and hypopressive exercises."
16005557|NCT02846480|Other|surgical treatment|Surgical correction of POP.
16005558|NCT02846480|Other|behavior therapy|At hospital discharge, patients will receive a fact sheet on the sanitary and behavioral measures recommended for the prevention of POP and urinary incontinence (proper weight, prevent constipation, avoid weight bearing and cough and high impact exercise).
16005559|NCT02846467|Other|Informed consent trough a portable video media|Information provided to patients using the mobile application (iURO app)
16005560|NCT02846467|Other|Written informed consent|Information provided to patient trough the traditional informed consent (written IC) for transurethral resection of bladder or prostate.
16005561|NCT02846454|Other|inulin|Investigate the satiating effects of consuming 4g/d inulin in 2 daily doses of 2g
16005562|NCT02846454|Other|arabinoxylan|Investigate the satiating effects of consuming 4g/d arabinoxylan in 2 daily doses of 2g
16005563|NCT02846441|Procedure|hepatobiliary scintigraphy|99mTc-mebrofenin hepatobiliary scintigraphy with single photon emission computed tomography (SPECT)
16005564|NCT02846428|Drug|5-Fluorouracil|5-FU will be administered at 500 mg/m^2 by short IV infusion on Day 1 of each 21-day cycle during neoadjuvant treatment period for 4 cycles.
16005565|NCT02846428|Drug|Capecitabine|Capecitabine will be administered at 900 mg/m^2 orally twice daily on Days 1-14 of each 21-day cycle for 4 cycles during neoadjuvant treatment period.
16005566|NCT02846428|Drug|Cyclophosphamide|Cyclophosphamide will be administered at 500 mg/m^2 by short IV infusion on Day 1 of each 21-day cycle for 4 cycles during neoadjuvant treatment period.
16005567|NCT02846428|Drug|Docetaxel|Docetaxel will be administered at 100 mg/m^2 by IV infusion on Day 1 of each 21-day cycle for 4 cycles during adjuvant treatment period.
16005568|NCT02846428|Drug|Epirubicin|Epirubicin will be administered at 100 mg/m^2 by short IV infusion on Day 1 of each 21-day cycle for 4 cycles during neoadjuvant treatment period.
16005569|NCT02846415|Behavioral|Play Intervention for Dementia|"8 weekly session, 45-75 minutes each
~Play with toys
~Sessions will be facilitated by a play specialist, trained play assistants, and centre staff."
16005570|NCT02846402|Other|Oral HIV Self-Testing|The Oral HIV Self-Test is an in-home test that uses an oral swab to collect samples of oral mucosa that is used to detect the presence of HIV antibodies. The test is read after 20 minutes by the user. The test can be done by an individual at any time and place of the user's choosing. The test is read visually.
16005571|NCT02846389|Other|Moderate Exercise|Aerobic training utilizing the portable stationary pedal exerciser (Pedlar) which contains two cycling pedals mounted to a stationary block that allows patients to exercise while sitting. Participants are required to perform 15 minutes/day of aerobic exercise using the Pedlar device on radiation treatment days; during a standard radiation course, this will typically yield 75 minutes/week of aerobic time.
16005572|NCT02846376|Drug|Nivolumab|Nivolumab is a fully humanized immunoglobulin 4 (IgG4) monoclonal antibody (mAb) which binds to PD-1 (CD279) with nanomolar affinity and shows a high degree of specificity for PD-1; blocking binding of PD-1 to PD-L1 and PD-L2. Nivolumab binds selectively to human PD-1 and does not bind to other members of the cluster of differentiation protein 28 (CD28) family.
16005573|NCT02846376|Drug|Ipilimumab|Ipilimumab is a recombinant, human mAb that binds to the cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4). Ipilimumab is an immunoglobulin 1 (IgG1) kappa immunoglobulin with an approximate molecular weight of 148 kilo-Daltons (kDa). Ipilimumab is produced in mammalian (Chinese hamster ovary) cell culture.
16005605|NCT02846090|Drug|Dexmedetomidine to reduce the IOP|Dexmedetomidine 50 micrograms group (D50) in which peribulbar block was given using 10 ml of a mixture of local anesthetics. The mixture was composed of 5 ml of 0.5% bupivacaine +4.5 ml of 2% lidocaine +0.5ml of 50 micrograms of Dexmedetomidine with 150 IU hyaluronidase.
16005606|NCT02846077|Other|No intervention. Observation only|No intervention. Observation only
16005607|NCT02846064|Procedure|Autograft of cryopreserved ovarian tissue|Orthotopic transplantation
16005608|NCT02846051|Procedure|venous mapping|clinical examination + doppler echo
16071143|NCT02374567|Drug|Amitriptyline|
16005574|NCT02846363|Other|public awareness campaign|"The public awareness campaign was based on improving knowledge and skills of public to recognize stroke symptoms. The campaign materials were:
~3 posters presenting the three main symptoms of stroke and the need to call the EMS immediately
~A leaflet on stroke will be created
~3 participatory movies: These films will be posted on YouTube and broadcast on the website and the Facebook campaign page
~Actions on social networks: A Facebook group will be created (AVC: votre appel peut sauver des vie).
~A website developed with ICAP - UCBL Lyon1 (http://avc.univ-lyon1.fr/)
~On the occasion of World Stroke Day, held annually on 29 October, will be organized an event in Lyon in order to educate and inform the general public about stroke: the main symptoms and reflexes to adopt in case of stroke: call the EMS urgently"
16005575|NCT02846350|Behavioral|Motivational Interviewing|"The training will include MI skills and elements identified as most effective, MI spirit (collaboration, evoking patient motivation, honoring patient autonomy, recognizing and reinforcing change talk, and rolling with (not fighting) resistance. Physicians utilizing MI will learn to engage with patients in an empathic, nonjudgmental manner and to pose simple but strategic questions to motivate change; when patients resist change, the physician learns to ''roll'' with resistance instead of confronting it. If and when the patient is ready to initiate a change, the physician will be prepared to support their decision"
16005576|NCT02846337|Procedure|ULTRAFILTRATION|"Peritoneal dialysis: at least one daily contact, 5 days a week minimum, with a hypertonic solution. Le number of contact et the stasis duration will be decided by the practitioner.
~Hemodialysis: at least one hemodialysis per week, one hemofiltration and/or hemodiafiltration per week, and at least 2 liter of ultrafiltrate extraction per week. In case of serious interdialytic weight gain, and/or hemodynamic unsteadiness, sessions can be up to 6 per weeks. Sessions duration will be adjusted to the needful ultrafiltrate and hemodynamic tolerance.
~Isolated ultrafiltration: at least once a week, and includes an extraction of minimum 2 liter ultrafiltrate in less than 4 hours. It could be done, according to routines and department capacity, on a hemodialysis generator, plasmatic exchange generator, or mobile ultrafiltration device."
16005577|NCT02846337|Procedure|ENHANCED MEDICAL TREATMENT|"Close cardiologic and nephrologic follow-up, minimum 4 times a year, This incidence matches the heart failure, and chronic kidney failure care guidance for our sample
~Medical care adjustment in order to apply European and American guidance for chronic heart failure care
~Hydric, caloric, peptic and sodium input evaluation by a dietician, and adjustment if needed
~Physical rehabilitation suggestions by a physiologist
~Evaluation of an interventional approach requirement, and implementation if needed (pacemaker, defibrillator, cardiac resynchronization, diagnosis and therapeutic coronary angiography, ventricular stimulator) according to European and American guidance."
16005578|NCT02846324|Drug|GBT440|Capsules which contain GBT440 drug substance in Swedish orange
16005579|NCT02846324|Drug|Placebo|Placebo capsules
16005580|NCT02846311|Device|Flu Test|
16005581|NCT02846298|Biological|Drug Monitoring|Evaluation of Pharmacokinetic / Pharmacodynamic Data and Interest Individualized Therapeutic Drug Monitoring Glycopeptides and β-lactam-aminoglycoside ICU
16005582|NCT02846285|Other|No intervention|
16005583|NCT02846272|Procedure|Observation|Observation of MRI changes in subjects
16005584|NCT02846246|Other|Person-centred and health-promoting home care service|Firstly, staff will take part in an educational program on the content and operationalization of the central theoretical components person-centeredness and health exploratory conversation. Secondly, staff will participate in supervised skill training in how to accomplish person-centered and health exploratory conversation. Thirdly, the staff will have a person-centred and health exploratory conversation with purpose to evaluate the extent to which current home care service practice meet the older person´s need and maintain or make rearrangement in provided care to maximise older people's health. Finally, staff will participate in clinical supervisory sessions with an aim to support and facilitate ongoing operationalization phase.
16005585|NCT02846246|Other|Care as usual|The control group will be offered a lecture about dementia based on staff wishes and a usual care paradigm will guide the control units, i.e. a continuation with practice as usual. Control units will receive the intervention protocol and study results at the end of the study.
16005586|NCT02846233|Drug|GLP1 receptor agonist|"Albiglutide or Dulaglutide will be added to a basal insulin."
16005587|NCT02846233|Drug|basal insulin|The participant will continue with the basal insulin.
16005588|NCT02846233|Drug|SGLT2 inhibitor|"Empagliflozin will be added to a basal insulin."
16005589|NCT02846233|Drug|Metformin|The participant will continue with metformin.
16005590|NCT02846220|Behavioral|Overcoming Immunity to Change health coaching|
16005591|NCT02846207|Drug|Yiqi huoxue|Buyang Huanwu demolition, which includes: Astragalus 60g, Radix Paeoniae Rubra 15g, ligusticum wallichii 12g, angelica sinensis 20g, earthworm 12g, flos carthami 12g and peach seed 12g. Oral administration, twice one day, for 12weeks.
16005592|NCT02846207|Drug|Yiqi group|Astragalus 60g.Oral administration, twice one day, for 12weeks.
16005593|NCT02846207|Drug|Huoxue group|Radix Paeoniae Rubra 15g, ligusticum wallichii 12g, angelica sinensis 20g, earthworm 12g, flos carthami 12g and peach seed 12g. Oral administration, twice one day, for 12weeks.
16005594|NCT02846207|Drug|placebo|Dextrin,oral administration, twice one day, for 12weeks.
16005595|NCT02846194|Behavioral|brief guided imagery|
16005596|NCT02846181|Drug|[14C]-SK-1405|
16005597|NCT02846155|Other|clear water|the patients just drink common clear water before Magnetic-controlled Capsule Endoscopy examination
16005598|NCT02846155|Drug|simethicone|the patients drink clear water and simethicone (Espumisan; Berlin-Chemie, Germany, containing 40 mg simethicone in 1 mL emulsion) before Magnetic-controlled Capsule Endoscopy examination
16005599|NCT02846155|Drug|simethicone combined with pronase|the patients drink simethicone (Espumisan; Berlin-Chemie, Germany, containing 40 mg simethicone in 1 mL emulsion)，pronase granules（Deyou；Beijing Tide Pharmaceutical Co，China,containing 20,000iu pronase），and clear water before Magnetic-controlled Capsule Endoscopy examination
16005600|NCT02846142|Drug|PTI-428|
16005601|NCT02846142|Other|Placebo|
16005602|NCT02846142|Drug|ethinyl estradiol and levonorgestrel|
16005603|NCT02846116|Other|Prosthetic crown|
16005604|NCT02846103|Other|Biological samples|blood and tumor tissue samples
16005609|NCT02846025|Dietary Supplement|Folate and capsule of oil hazel|rich diet aministracao folate and capsule of oil hazel
16005651|NCT02845752|Drug|Stiolto Respimat|Oral inhalation spray
16005611|NCT02846025|Dietary Supplement|antioxidant and placebo|antioxidant diet (90μg folate) and placebo capsule
16005612|NCT02846012|Other|CSCM2|
16005613|NCT02845999|Biological|allogenic immunotherapy based on Natural Killer cells adoptive transfer|day -1 : donor NK cell purification ; day 0 : adoptive transfer (according to a dose escalation) ; Dose escalation protocol : 3.10^6 ; 8.10^6 and 12.10^6 cells/kg of recipient body weight
16005614|NCT02845999|Biological|cetuximab|day -8 : cetuximab 400 mg/m2 ; day -1 and every week (for 7 weeks) : cetuximab 250 mg/m2
16005615|NCT02845999|Drug|Cyclophosphamide|day -6 : cyclophosphamide 60 mg/Kg
16005616|NCT02845999|Drug|fludarabine|day -6 to day -2 : fludarabine 25 mg/m2
16005617|NCT02845999|Drug|interleukin-2|day -1 : addition of 1000 UI/ml of interleukin 2 to NK cells and overnight culture at 37°C, 5%CO2 ; day 0, hour +12 : 10 MUI of interleukin 2 injection, 2 times a week during 3 weeks.
16005618|NCT02845986|Procedure|Laparoscopic Spleen-Preserving No.10 Lymph Node Dissections|After exclusion of T4b, bulky lymph nodes, or distant metastasis case et al. Laparoscopic spleen-preserving No.10 lymph node dissections will be performed with curative treated intent in patients with locally advanced upper third gastric adenocarcinoma.
16005619|NCT02845986|Drug|oxaliplatin|oxaliplatin or platinum-based chemotherapy is used when the patients undergo adjuvant chemotherapy after the surgery.
16005620|NCT02845973|Biological|gut microbiota|
16005621|NCT02845960|Behavioral|rapid recovery|rapid recovery
16005623|NCT02845934|Other|blood sample|additional sampling of blood (estimated volume 6 mL for each sampling) on day of suspicion of the mucormycosis and then twice a week up to a maximum of 8 weeks.
16005624|NCT02845921|Other|leg elevation|A stand making an angle of 30 degree to the horizontal is used to elevate both the legs
16005625|NCT02845921|Other|leg wrapping|Esmarch bandage is used to wrap each lower limb
16005626|NCT02845921|Other|control|no intervention has been done
16005627|NCT02845908|Drug|POF|Paclitaxel plus Oxaliplatin plus Leucovorin plus 5-FU
16005628|NCT02845908|Drug|FOLFOX|Oxaliplatin plus Leucovorin plus 5-FU
16005629|NCT02845908|Drug|FOLFOX plus PAC(ip)|FOLFOX plus intraperitoneally PAC
16005630|NCT02845895|Other|Caregiver dedicated|Organization of nutrition screening with the help of a caregiver
16005631|NCT02845895|Other|Classic strategy|Classic organization with the training of the department team
16005632|NCT02845882|Drug|Prednisone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Daunorubicin, 6-mercaptopurine|Prednisone 60 mg/m2 per day,d1-28, then taper over 9 days; Vincristine 1.5 mg/m2 per day (max 2 mg),d1,8, 15, 22; Daunorubicin 30 mg/m2 per dose,d5,12,19; Pegylated-asparaginase 2000 IU/m2 per dose,d16,36,57; Cyclophosphamide 1000 mg/m2 per dose, d36, 57; Cytarabine 75 mg/m2 /d, d36-42,d 57-63; 6-Mercaptopurine 60 mg/m2 per day, d36-42, 57-63; Triple it, d8,29,36,57 1,8, 15, 22
16005633|NCT02845882|Drug|6-mercaptopurine,Methotrexate|6-Mercaptopurine 25 mg/m2 per day, d1-56; Methotrexate 5g/m2 per dose, d1, 15, 29, 43; Triple it, d1, 15, 29, 43;
16005634|NCT02845882|Drug|Dexamethasone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Doxorubicin, 6-mercaptopurine|Dexamethasone 10 mg/m2 per day, d1-7, d15-21; Vincristine 1.5 mg/m2 per day (max 2 mg), d1, 8, 15; Doxorubicin 30 mg/m2 per dose, d1, 8, 15; Pegylated-asparaginase 2,000 IU/m2 per dose, d3, 24; Cyclophosphamide 1000 mg/m2 per dose, d29; Cytarabine 75 mg/m2 /d, d29-35; 6-Mercaptopurine 60 mg/m2 per day, d29-35; Triple it, d1, 29;
16005635|NCT02845882|Drug|Dexamethasone,Vincristine, Pegylated-asparaginase, Cytarabine, Cyclophosphamide, Methotrexate|Dexamethasone 20mg/m2/day, d1-5; Vincristine 1.5 mg/m2 per day (max 2 mg), d1, 6; Methotrexate 5000mg/m2, d1; Cyclophosphamide 200mg/m2/dose, q12h×5, d2-4; Cytarabine 2000mg/m2/dose, ，q12h×2, d5; Pegylated-asparaginase 2,000 IU/m2 per dose, d6; Triple it, d1;
16005636|NCT02845882|Drug|Dexamethasone, Vindesine, Methotrexate, Ifosfamide, Daunorubicin, Pegylated-asparaginase|Dexamethasone 20mg/m2/day, d1-5; Vindesine 3mg/m2（MAX 5mg）, d1, 6; Methotrexate 5000mg/m2, d1; Ifosfamide 800mg/m2/dose, q12h×5,d2-4; Daunorubicin 25mg/m2/dose, d5; Pegylated-asparaginase 2,000 IU/m2 per dose, d6; Triple it, d1;
16005637|NCT02845882|Drug|Dexamethasone, Cytarabine, Etoposide, Pegylated-asparaginase|Dexamethasone 20mg/m2/day, d1-5; Cytarabine 2000mg/m2/dose，q12h× 4, d1, 2; Etoposide 100mg/m2/dose，q12h×5, d3,4,5; Pegylated-asparaginase 2,000 IU/m2 per dose, d6; Triple it, d5;
16005638|NCT02845882|Drug|Methotrexate, 6-mercaptopurine|6-mercaptopurine 50 mg/m2 per day, Daily; Methotrexate 20 mg/m2 per dose, Once a week; Triple it, Once every 4 weeks for 12 times;
16005639|NCT02845869|Device|THOR Laser LX2 System|Treatment session will take up to 25 minutes and will include stimulation of local lymph nodes and soft tissue, de-activation of trigger points, and eliciting analgesia.
16005640|NCT02845869|Device|Sham Therapy|The therapeutic light will be turned off but the system will produce similar noises and mild heat.
16005641|NCT02845856|Drug|Cetuximab|400 mg/m2 IV over 120 minutes on day 1 of cycle 1 only, and 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations
16005642|NCT02845856|Biological|NK immunotherapy|For each procedure, 10 billion cells will be infused in 4 times
16005643|NCT02845843|Drug|Combination of Lopinavir /Ritonavir and Interferon beta-1b|Lopinavir /Ritonavir 400mg +100 mg / ml twice daily for 14 days and Interferon beta-1b 0.25 mg subcutaneous every alternate day for 14 days
16005644|NCT02845843|Drug|Placebo|Same characteristics as Lopinavir /Ritonavir and Interferon beta-1b to maintain blinding
16005645|NCT02845817|Other|Qualitative research|Semi-structured interviews
16005646|NCT02845804|Device|Alpine|
16005647|NCT02845791|Behavioral|Interactive Lifestyle programme workshop|Participants will attend eight 90 minute sessions of an interactive lifestyle programme along with their parent(s)/guardian(s).
16005648|NCT02845778|Drug|Melatonin|Each sachet contains 0.5 g
16071144|NCT02374567|Drug|Nortriptyline|
16005652|NCT02845752|Drug|Placebo Respimat|Oral inhalation spray
16005653|NCT02845739|Other|Kidney transplanted patients|
16005654|NCT02845726|Other|Stent examination, urinary analysis, USSQ questionnaire|
16005655|NCT02845713|Drug|Ivermectin, Diethylcarbamazine Albendazole (IDA)|To evaluate the safety and tolerability of triple drug therapy (a single dose of ALB, IVM and DEC)
16005656|NCT02845700|Behavioral|Perceptual Retraining Treatment|"Perceptual retraining involves the systematic presentation of diluted malodors (i.e., odors perceived as threatening). For each individual, vials on either side of a pre-determined and ideographic detection threshold will be presented. During the retraining, participants will be given feedback to shift their bias away from the malodorous target stimuli. For example, in the context of diluted solutions participants will be given the feedback that they are correct when a neutral response is given to solutions that are above the starting threshold (stronger malodor) and incorrect when a target is endorsed that is below the starting threshold (weaker malodor)."
16005657|NCT02845700|Behavioral|Sham Neutral training|Control condition using systematic presentation of diluted neutral-neutral odor pairs.
16005658|NCT02845674|Drug|OTX-101 0.09%|0.09% cyclosporine nanomicellar solution
16005659|NCT02845661|Drug|Dexmedetomidine|a bolus of dexmedetomidine was administered intravenously 15 min after spinal anesthesia,and the initial dose in group 1 was started from 0.9 µg/kg
16005660|NCT02845661|Drug|Dexmedetomidine|a bolus of dexmedetomidine was administered intravenously 15 min after spinal anesthesia,and the initial dose in group 2 was started from 1.0 µg/kg
16005661|NCT02845661|Drug|Dexmedetomidine|a bolus of dexmedetomidine was administered intravenously 15 min after spinal anesthesia,and the initial dose in group 3 was started from 1.1 µg/kg
16005662|NCT02845648|Drug|anticholinergic|Initial anticholinergic therapy to all patients
16005663|NCT02845635|Other|Personal history of multiple sclerosis|Participants will be stratified into one of four cohorts based on their experience (or lack of experience) with the three major forms of multiple sclerosis.
16005664|NCT02845622|Dietary Supplement|Hazelnut|This dietary supplement contains 30 g of hazelnut.
16005665|NCT02845622|Dietary Supplement|Cocoa|This dietary supplement contains 2.5 g of cocoa powder.
16005666|NCT02845622|Dietary Supplement|No hazelnuts / No cocoa|This dietary supplement does not contain hazelnut nor cocoa powder.
16005667|NCT02845622|Dietary Supplement|Cream|This dietary supplement is just a cream obtained by grinding hazelnuts.
16005668|NCT02845622|Dietary Supplement|Snack|This dietary supplement is a commercial snack containing either hazelnut or cocoa or both.
16005669|NCT02845609|Drug|Sialic Acid-Extended Release|Oral drug of Sialic acid
16005670|NCT02845596|Drug|cyclosporine|cyclosporine
16005671|NCT02845596|Procedure|Matched Unrelated Donor Hematopoietic Stem Cell Transplant|Matched Unrelated Donor (MUD) Hematopoietic Stem Cell Transplantation (HSCT)
16005672|NCT02845596|Drug|horse anti-thymocyte globulin (ATG)|horse anti-thymocyte globulin (ATG)
16005673|NCT02845596|Drug|rabbit anti-thymocyte globulin (ATG)|rabbit anti-thymocyte globulin (ATG)
16005674|NCT02845596|Drug|methotrexate|methotrexate
16005675|NCT02845596|Drug|fludarabine|fludarabine
16005676|NCT02845596|Drug|cyclophosphamide|cyclophosphamide
16005677|NCT02845596|Radiation|low-dose total body irradiation (TBI)|low-dose total body irradiation (TBI)
16005678|NCT02845596|Procedure|Immunosuppressive Therapy (IST)|Immunosuppressive Therapy (IST)
16005679|NCT02845570|Other|68Ga-DOTANOC PET/MRI|
16005680|NCT02845570|Other|18F-FDG PET/MRI|
16005681|NCT02845557|Other|OGTT and IVGTT tests|
16005682|NCT02845544|Other|Pilates-based exercises|
16005683|NCT02845531|Device|Implantable Cardioverter Defibrillator|Implantable Cardioverter Defibrillator and Optimal Medical Therapy
16005684|NCT02845531|Drug|Optimal Medical Therapy|
16005685|NCT02845518|Procedure|Cardiac magnetic resonance imaging (cMRI)|"Right ventricular contouring and indexed aortic flow measurement from cMRI will be performed locally with the dedicated software used in clinical practice by the physicians of each centre. Cardiac index and RVEF will be derived from these measures. MRI interpretation will be performed blind with respect of clinical and RHC data.
~A self-administered questionnaire made up of 2 Lickert scales will be given to all patients on visits V1, V2 or V3 and V9.
~To constitute a biobank for diagnosis and prognosis purposes blood samples will be taken at visits V1, V2 or V3 and V9."
16005686|NCT02845505|Other|Intravascular Ultrasound, coronary computed tomography angiography|
16005687|NCT02845492|Other|Qigong|Qigong is a mind-body exercise based around gentle exercise and the cultivation of a meditative focus on bodily sensations
16005688|NCT02845492|Other|Complete Health Improvement Program (CHIP)|The CHIP program is a validated weekly wellness and exercise program designed to promote health and wellbeing.
16005689|NCT02845479|Other|Integrative Care|Standardized supplemental/natural health product, physical, nutritional and mental/emotional recommendations based on the phases of standard care (neo-adjuvant, perioperative, adjuvant and long-term maintenance).
16005690|NCT02845466|Biological|Becaplermin|0.25 cm of 100 µg/g Becaplermin gel topically per 1cm² of ulcer area applied 3 times per week for 6 weeks.
16005691|NCT02845466|Device|Promagran Dressing|44% oxidized regenerated cellulose (ORC), 55% collagen and 1% silver-ORC wound dressing applied 3 times per week for 4 weeks.
16005692|NCT02845466|Device|Placebo Dressing|Inactive wound dressing.
16005693|NCT02845453|Drug|Quetiapine|Participants will be randomly assigned Quetiapine and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study.
16005694|NCT02845453|Drug|Placebo|Participants will be randomly assigned to placebo and will be titrated to the maximum daily dose over three weeks and then enter a dose maintenance phase for weeks 4 through 8 of the study.
16005695|NCT02845440|Other|Academic Detailing|Academic detailing (AD) is a targeted continuing medical education (CME) strategy that adapts social marketing techniques, using mixed interactive and didactic formats in individual and group settings integrated into the practice setting to promote beneficial changes in medical care. AD helps clinicians understand and adopt targeted evidence-based practices and is one of the few Continuing Medical Education (CME) interventions that has consistently demonstrated improved alignment of physician prescribing behavior with evidence-based practice.
16005806|NCT02844621|Drug|Omeprazole|20mg orally once daily
16005696|NCT02845440|Other|Community Health Worker|Community Health Worker (CHW) The CHW will offer to support patients and prescribers in health promotion and preventive care in general and specifically to support communication between the primary care provider and patient regarding smoking status, smoking cessation, and to aid implementation of any smoking cessation treatments recommended by prescribers. CHWs will complete the standard CHW certificate training program in general preventive medicine, available through the Boston Public Health Commission. CHWs will then receive the additional specialized training.
16005697|NCT02845440|Other|Treatment as Usual (TAU)|Usual care (TAU) for adults with SMI in Massachusetts consists of rehabilitation services publicly funded by the state and traditional fee for service outpatient medical and psychiatric care. Importantly, medical care is not programmatically integrated with the psychiatric rehabilitation services.
16005698|NCT02845427|Device|closed suction drain|using closed suction drain system postoperative
16005699|NCT02845427|Procedure|no suction drain|the surgical wound will be closed with no suction drain
16005700|NCT02845414|Drug|CD133KDEL (dCD133KDEL)|Patients will receive dCD133KDEL at the assigned dose level via a 30-minute intravenous infusion on days 1, 3, 5, 8, 10 and 12 (total of 6 doses) of a 28-day cycle.
16005701|NCT02845401|Other|Stop NA therapy|Cases will stop antiviral therapy
16005702|NCT02845388|Drug|Sildenafil citrate|
16005703|NCT02845388|Drug|estradiol valerate|
16005704|NCT02845375|Drug|Sugammadex|Sugammadex will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.
16005705|NCT02845375|Drug|Neostigmine|Neostigmine will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.
16005706|NCT02845375|Drug|Placebo|Placebo will be administered following a period of muscle relaxation after wich respiratory measurements will be obtained.
16005707|NCT02845362|Other|Sydney Swallow Questionnaire|The Sydney Swallow Questionnaire (SSQ) is a validated self-report symptom questionnaire, it contains 17 items recorded as visual analogue scales and is a tool specifically designed for evaluation of swallowing difficulties.
16005708|NCT02845349|Drug|Vortioxetine|The study drug, vortioxetine received approval from the U.S. Food and Drug Administration (FDA) to treat adults with major depressive disorder. This study is being done to determine its effectiveness in a specialized population, i.e. those who have developed major depression after a traumatic brain injury. As patients who have sustained a TBI are medically fragile and sensitive to side-effects of medications, it is important to test the effectiveness and safety of vortioxetine in this population.
16005709|NCT02845349|Drug|Placebo|A placebo comparator will be used in one subset of patients.
16005710|NCT02845336|Drug|Celecoxib|celecoxib 100mg PO twice per day for 3 months
16005711|NCT02845336|Drug|artificial tears|Standard care for mild thyroid eye disease is lubrication with artificial tears (over the counter), avoidance of cigarette smoke.
16005714|NCT02845310|Procedure|Restricted fluid therapy group|Patients will receive restricted fluid management (2ml/Kg/h) with concomitant SVV monitoring using ICON cardiometry device. GDT protocol will be used to fulfil the two targets (SVV < 10% - MAP >65 mmHg). A fluid bolus of 200 ml Lactated ringer will be infused if SVV is more than 10% for 5 minutes, the dose will be repeated every 10 minutes if SVV is still above 10%. If the total fluid boluses reached 20 ml/Kg in a patient with MAP > 65 mmHg, no fluid boluses will be infused unless there is evident blood loss or hypotension. If MAP was achieved (>65mmHg) at any time, the first three steps in the protocol will be bypassed. If MAP was not achieved after reaching 20 ml/Kg , norepinephrine (inotropes) will be given as shown in fig. 1 with dose of 0.01ug/kg/min.
16005715|NCT02845310|Procedure|Standard fluid management|Patients will receive standard fluid management of 6 ml/Kg/h plus rescue fluid boluses of 200 ml lactated ringer if Mean arterial pressure (MAP) decreased less than 65 mmHg and central venous pressure less than 8 mmH2o.
16005716|NCT02845297|Drug|pembrolizumab|Intravenous pembrolizumab
16005717|NCT02845297|Drug|Azacitadine|Intravenous or subcutaneous
16005718|NCT02845284|Behavioral|enhanced group support|Routine Care plus enhanced group support, and peer education beginning every 4 weeks post enrollment to delivery and at 6 and 10 weeks, 3, 6 and 9 months post delivery.
16005719|NCT02845284|Behavioral|enhanced individual support|Routine Care plus individual peer education and support beginning every 4 weeks post enrollment to delivery and at 6 and 10 weeks, 3, 6 and 9 months post delivery.
16005720|NCT02845271|Drug|placebo|"Pharmaceutical form:solvent for parenteral use
~Route of administration: intraarticular"
16005721|NCT02845271|Drug|GZ389988|"Pharmaceutical form:suspension for injection
~Route of administration: intraarticular"
16005722|NCT02845271|Drug|acetaminophen or paracetamol|"Pharmaceutical form: tablet
~Route of administration: oral"
16005723|NCT02845271|Drug|fixed combination of paracetamol + codeine|"Pharmaceutical form: capsule
~Route of administration: oral"
16005724|NCT02845271|Drug|fixed combination of paracetamol + tramadol hydrochloride|"Pharmaceutical form: tablet
~Route of administration: oral"
16005725|NCT02845258|Procedure|Pancreatic pseudocyst drainage with a plastic or self-expandable metallic stent (SEMS)|"Pancreatic pseudocyst drainage with a plastic or self-expandable metallic stent (SEMS):
~This procedure is to be regarded as a clinical routine procedure since a couple of years back. The type of stent (material? length? thickness?), the cyst appearance (large? infected? cyst wall thickness?) and the type of access (transgastric? transduodenal?) may however vary from patient to patient.
~In this study we perform EUS-drainage using different types of equipment on a wide range of pancreatic pseudocysts of different appearance and character. All procedures are performed as recommended. The very aim of the study is to investigate which technique and Equipment is to be preferred in different scenarios."
16005726|NCT02845245|Other|3D printed plastic model prototype|
16005727|NCT02845245|Other|3D CT scan|
16005728|NCT02845245|Other|Plain film radiographs|
16005729|NCT02845232|Other|Transfusion|The number and type of blood products administered were registered from the time of diagnosis to the time of death corresponding for all patients to the time of last follow-up. Transfusion of a single unit of packed red blood cell (PRBC) or one whole blood-derived platelet concentrate (PC) or fresh frozen plasma (FFP) was considered a transfusion event and considered for statistical analysis.
16071145|NCT02374567|Drug|Doxepin|
16005730|NCT02845219|Drug|semaglutide|Oral administration once daily alone or together with oral contraceptive.
16005731|NCT02845219|Drug|SNAC|Oral administration once daily together with oral contraceptive.
16005732|NCT02845219|Drug|Microgynon®|Oral administration once daily alone or together with oral semaglutide or SNAC.
16005733|NCT02845206|Procedure|Patient specific cutting blocks|'MyKnee' Instrumentation
16005734|NCT02845206|Procedure|Conventional cutting blocks|Standard Instrumentation
16005735|NCT02845193|Device|Modified Nasoalveolar molding|Infants will receive this appliance which is a maxillary plate with nasal stent in addition to taping on the upper lip (taping is routine step in Grayson's nasoalveolar molding technique).
16005736|NCT02845193|Device|Taping|Infants will receive a tape only on the upper lip segments to mold it to touch each other.
16005737|NCT02845193|Device|CAD/NAM|computer aided design NAM
16005738|NCT02845180|Procedure|Adipose Allograft Extracellular Matrix (AAM) Injection|Injection followed by surgery
16005739|NCT02845167|Other|Preoperative exercise|Patients will perform 3 consecutive days of 60 min submaximal cycling exercise at a moderate exercise intensity. During the 60 min of exercise, patients will be provided with three equally spaced 3min rest periods
16005740|NCT02845154|Other|bolus purge|complete and uninterrupted purge
16005741|NCT02845154|Other|Intermittent purge|intermittent portal purge
16005742|NCT02845141|Procedure|Actifuse|bone tunnel filled with Actifuse
16005743|NCT02845141|Procedure|bone graft|bone graft to fill bone tunnel
16005744|NCT02845115|Device|Conventional implantation|"Usual implantation technique of a middle ear implant. The principle of the ossicular stimulator middle ear transducer MET 7000 (Middle Ear Transducer, METTM) is to directly transmit sounds on the ossicles bypassing the outer ear. Their constraint is the surgical placement of the implant.
~MET 7000 system (OTOLOGICS LLC, USA) is the implant that the investigators will use for their patients. The stimulator is usually placed against the body of the anvil by simple contact in the case of sensorineural hearing loss. In the case of mixed hearing loss, the stimulator will come in contact with the bracket using a titanium clip (ossicular prosthesis used in otologic surgery for ossiculoplasties). The optimized version corresponds to the use of the conventionally used in mixed deafness and applied to neurosensory deafness art. It is screwed onto the mastoid bone, the motor is suspended in the mastoid cavity and transmits vibrations to the body of the anvil by simple contact of the transducer."
16005745|NCT02845115|Device|optimized implantation with laser velocimetry|
16005746|NCT02845102|Other|Pre-Post Feasibility|The feasibility testing phase will include 25 subjects. Total duration of pre-post feasibility testing will be 6 weeks upon retrieval of the RA-CBT tablet and follow up questionnaires, quantitative exit interview, and/or an optional extended qualitative exit interview. The extended exit interview is a qualitative semi-formal interview focusing on gathering participant experiences working with the intervention, the barriers and facilitators encountered, as well as overall feedback for the pre-post feasibility study and the relational agent.
16005747|NCT02845076|Other|Protocol for weaning of noninvasive ventilation|3 protocols for weaning of noninvasive ventilation will be compared
16005748|NCT02845063|Behavioral|concentric cardiovascular training|Subjects will carry out 8 weeks of cardiovascular training by an interval type of protocol that includes a high repetition number of concentric type contractions on a softrobotic device.
16005749|NCT02845063|Behavioral|eccentric cardiovascular training|Subjects will carry out 8 weeks of cardiovascular training by an interval type of protocol that includes a high repetition number of eccentric type contractions on a softrobotic device.
16005750|NCT02845063|Genetic|ACE genotyping|Subjects will be genotyped for the ACE-I/D gene polymorphism.
16005751|NCT02845050|Drug|Vinflunine|"One cycle is defined as a period of 3 weeks of treatment:
~Vinflunine (280 mg/m²) on Day 1, every 21 days as a 20 minute IV infusion
~Cisplatin (70 mg/m²) on Day 2, every 21 days
~4 cycles of neo-adjuvant chemotherapy prior to radical cystectomy"
16005752|NCT02845050|Drug|Cisplatin|"One cycle is defined as a period of 3 weeks of treatment:
~Vinflunine (280 mg/m²) on Day 1, every 21 days as a 20 minute IV infusion
~Cisplatin (70 mg/m²) on Day 2, every 21 days
~4 cycles of neo-adjuvant chemotherapy prior to radical cystectomy"
16005753|NCT02845050|Procedure|Radical cystectomy|max. 4 weeks after 4 cycles of neo-adjuvant treatment radical cystectomy will be performed
16005754|NCT02845037|Drug|BIA 5-453|BIA 5-453 Gelatine capsule for oral administration (1, 10 or 20 mg). Single oral doses of BIA 4-543 2 mg, 10 mg, 20 mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg and 1200 mg were administered to subjects in fasting conditions.
16005755|NCT02845037|Drug|Placebo|Placebo Gelatine capsule for oral administration. The composition of the placebo is qualitatively the same but without BIA 5-453 pharmaceutical active ingredient (API).
16005756|NCT02845024|Drug|Doxycycline Group|Oral doxycycline 100mg was taken within 15 days
16005757|NCT02845024|Drug|placebo Group|Oral placebo was taken within 15 days
16005758|NCT02845011|Device|Audiovisual compression feedback|The Cardio First Angel™ (CFA; INOTECH, Nubberg, Germany) is a handheld device consisting of three components. The rescuer-side has a red palm-sized push-button with a pictogram illustrating proper use. The center unit is composed of a stable plastic base containing an arrangement of springs, and the patient-side consists of liquid-absorbent polyurethane foam. Application of 400 ± 30 Newtons of force results in an audible click alerting the rescuer to cease compression, and an additional click on decompression alerts the rescuer to resume compression.
16005759|NCT02845011|Other|Standard Manual Chest Compression|Cardiopulmonary resuscitation according to published international guidelines.
16005760|NCT02844998|Behavioral|physical activity|patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week
16005761|NCT02844998|Drug|dapoxetine 30 mg on demand|Dapoxetine, a short-acting selective serotonin reuptake inhibitors, has been utilized for the treatment of premature ejaculation in various countries
16005762|NCT02844985|Other|No Intervention|
16005763|NCT02844946|Behavioral|Acceptance and Commitment Therapy|Contextually focused form of cognitive behavioral psychotherapy that uses MINDFULNESS and behavioral activation to increase patients' psychological flexibility in areas such as ability to engage in values-based, positive behaviors while experiencing difficult thoughts, emotions, or sensations.
16005764|NCT02844933|Drug|Cannabidiol|Oral solution
16005765|NCT02844933|Drug|Placebo|Matching oral solution
16005766|NCT02844920|Device|Intrauterine ultrasound guided radio-frequency ablation|Radiofrequency ablation for the treatment of uterine fibroids
16005767|NCT02844907|Drug|Exendin (9-39)|Upon establishing a hyperglycemic clamp (target blood glucose at basal +3 mM) Exendin (9-39) will be infused.
16005768|NCT02844907|Drug|Dexamethasone|Between Visit-2 and Visit-3, Dexamethasone (4 mg tablet) once daily for 5-7 days.
16005769|NCT02844907|Other|Hyperglycemic Clamp|A variable infusion of 20% dextrose will begin to clamp the blood glucose at basal +3 mM.
16005770|NCT02844894|Drug|Dexmedetomidine|
16005771|NCT02844894|Drug|Esmolol|
16005772|NCT02844894|Drug|Placebo|normal saline
16005773|NCT02844881|Drug|Apatinib|Apatinib 850 mg p.o. qd every 28 days until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
16005774|NCT02844881|Biological|MASCT|Dendritic cells(DC) loaded with 17 antigens ih day 8, cytotoxic T lymphocytes ( CTL) induced by DC IV day 21-28, every 28 days until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
16005775|NCT02844868|Device|Active tDCS|During the first 20 min of training program, patient will have active tCDS : the patient received a 2 mA anodal tDCS over the lower limb ipsilesional motor area. The anodal electrode was positioned on the hotspot previously identified with TMS. The cathode was placed above the contralesional orbit.
16005776|NCT02844868|Device|Sham tDCS|During the first 20 min of training program, patient will have sham tCDS : the patient received a 2 mA anodal tDCS (only during the first and the last 30 seconds of the stimulation) and then, patient will have sham tDCS. The anodal electrode was positioned on the hotspot previously identified with TMS. The cathode was placed above the contralesional orbit.
16005777|NCT02844855|Behavioral|Cognitive tests|MMSE, (Folstein et al., 1975), HAD (Hospital Anxiety and Depression Scale; Zigmond & Snaith, 1983), a cognitive assessment (the 5 words test, Dubois et al., 2002; Trail Making test, Godefroy et al., 2008; BREF, Dubois et Pillon, 2000; Assessment of apraxia, Mahieux-Laurent, 2009) + the experimental task (verbal learning and action learning).
16005778|NCT02844842|Biological|Allergovac Poliplus|
16005779|NCT02844829|Other|Prostate MRI|MRI of the prostate prior to prostate biobsy
16005780|NCT02844816|Drug|Atezolizumab|Given IV
16005781|NCT02844803|Drug|Combination of Metformin + S. Baicalensis|the combination therapy for 8 weeks
16005782|NCT02844803|Drug|Combination of Metformin + Placebo|the metformin single therapy for 8 weeks
16005783|NCT02844790|Drug|insulin degludec/insulin aspart|A single dose of IDegAsp will be administered subcutaneously (s.c., under the skin).
16005784|NCT02844777|Drug|Placebo|200 mg applied once-daily for 28 days
16005785|NCT02844777|Drug|5% VDA-1102|200 mg applied once-daily for 28 days
16005786|NCT02844777|Drug|10% VDA-1102|200 mg applied once-daily for 28 days
16005787|NCT02844764|Biological|[StroMed + platelet rich plasma (PRP)]|Patients will be treated with autologous StroMed obtained by the Adipose Ultrasonic Cell Recovery Unit (AUCRU) and Platelet Rich Plasma (PRP) processed by the RegenLab (RegenKit BCT-3) PRP product each as direct injections to the affected joints at the time of initial treatment. Thereafter the affected joints will be treated with direct injections to the joint with Platelet Rich Plasma processed by RegenLab (RegenKit BCT-3) PRP product. Day 0 [StroMed + platelet rich plasma (PRP)], Day 7, 14 and 30 [PRP]
16005788|NCT02844751|Biological|[StroMed + platelet rich plasma (PRP)]|[Day 0] - Because no enzymes or drugs are added with this mechanical process, the resulting cell concentrate still contains the extra-cellular matrix. In addition, the cells have not been altered by manipulation with enzymes or culturing. This autologous, cell concentrate is of minimal risk to the patient with no artificial ingredients added. Also Platelet Rich Plasma processed by the RegenLab (RegenKit BCT-3) PRP product and by direct injection to the affected joint.
16005789|NCT02844751|Biological|[PRP] platelet rich plasma|Additional treatments with Platelet Rich Plasma processed by the RegenLab (RegenKit BCT-3) PRP product and by direct injection to the affected joint. Days 7,14 and 30
16005790|NCT02844751|Biological|[PRP] platelet rich plasma|Additional treatments with Platelet Rich Plasma processed by the RegenLab (RegenKit BCT-3) PRP product and by direct injection to the affected joint. Days 30 and 60
16005791|NCT02844738|Biological|[StroMed + platelet rich plasma (PRP)]|Patients will be treated with autologous StroMed obtained by the Adipose Ultrasonic Cell Recovery Unit and Platelet Rich Plasma processed by the RegenLab (RegenKit BCT-3) PRP product each as direct injections to the affected joints at the time of initial treatment. Thereafter the affected joints will be treated as direct injections to the joint with Platelet Rich Plasma processed by the RegenLab (RegenKit BCT-3) PRP product. Day 0 [StroMed + platelet rich plasma (PRP)], Days 7 and 14 [PRP]
16005792|NCT02844725|Drug|VVZ-149 injections|Colorless, transparent liquid in water for injection
16005793|NCT02844725|Drug|Placebo|water for injection
16005794|NCT02844712|Other|Evaluation of reexposure to a negatively tested betalactam|
16005795|NCT02844699|Drug|Mobilan (M-VM3)|Mobilan (M-VM3), innovative experimental drug based on non-replicate adenoviral delivery system consisting genomic vector coding TLR5-receptor and its ligand 502s.
16005796|NCT02844699|Drug|Placebo|5% infusion solution of dextrose (glucose)
16005797|NCT02844686|Other|Cardiac SPECT|3-D dynamic acquisition of cardiac SPECT at rest and after pharmacological stress
16005798|NCT02844673|Drug|Hydroxyurea|Patients will receive fixed dose Hydroxyurea therapy (15 mg/Kg/day) with standard monitoring
16005799|NCT02844673|Device|Mobile Directly Observed Therapy|Mobile DOT will consist of a web based medication adherence monitoring system that includes direct video confirmation of adherence using the patient's personal cellular telephone. Patients will receive alerts on their cell phone at pre-arranged times to remind them to take their medications.
16005800|NCT02844660|Biological|EpiCord|Weekly application of EpiCord and standard of care (moist wound therapy and offloading)
16005801|NCT02844660|Other|Standard of Care|moist wound therapy and offloading
16005802|NCT02844647|Other|Hyperpolarized Pyruvate (13C)|MRI contrast agent
16005803|NCT02844634|Drug|Doxycycline 100mg PO daily x 12 months|Immediate use of daily doxycycline (12 months duration, to start immediately)
16005804|NCT02844634|Drug|Tenofovir/emtricitabine 200/300mg PO daily|Daily use of tenofovir/emtricitabine
16005805|NCT02844634|Drug|Doxycycline 100mg PO daily x 6 months|Deferred use of doxycycline (6 months duration, to start 6 months post-randomization)
16071146|NCT02374567|Drug|Maprotiline|
16005807|NCT02844608|Other|Quality of Life Questionnaires|Patients will be asked to complete standardized HRQoL questionnaires: the EORTC QLQ-C30 with its specific module by cancer site (QLQ-BR23, QLQ-CR29, QLQ-LC13) at first visit before starting treatment and then before every medical consultation during four months.
16005808|NCT02844595|Behavioral|Standard cognitive-behavioural smoking cessation treatment|"Standard cognitive-behavioural smoking cessation treatment is an effective treatment for tobacco dependence. The treatment elements are: treatment contract, self-report and graphic representation of cigarette consumption, information about tobacco, stimulus control, activities for the avoidance of withdrawal syndrome, physiological feedback (CO in expired air) on cigarette consumption, nicotine fading (change of cigarette brands each week progressively decreasing the intake of nicotine and tar), and relapse-prevention strategies (assertion training, problem solving training, change tobacco related misconceptions, management of anxiety and anger, exercise, weight control, self-reinforcing, and changing irrational beliefs).
~Treatment will be delivered in eight 60-minute sessions over 8 consecutive weeks."
16005809|NCT02844595|Behavioral|Standard cognitive-behavioural smoking cessation treatment and behavioural activation|"Behavioural activation will be applied along with standard cognitive-behavioural smoking cessation treatment. The treatment elements are: those present in the standard cognitive-behavioural smoking cessation treatment, plus analysis of the relationship between behaviour and mood, identification of situations and behaviours that decrease mood, identifying avoidance behaviours, and identifying thoughts of rumination and worry, self-report of pleasant daily activities, pleasant activity scheduling to increase engagement in rewarding activities, and to reduce patterns of behavioural avoidance.
~Treatment will be delivered in eight 60-minute sessions over 8 consecutive weeks."
16005810|NCT02844582|Drug|Cabazitaxel|Given IV
16005811|NCT02844582|Drug|Prednisone|Given PO
16005812|NCT02844569|Device|Xenograft bone substitute|Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket will be treated with xenograft bone substitute. At 6 months post-extraction a dental implant will be placed at the extraction site.
16005813|NCT02844569|Device|Collagen dressing|Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a collagen dressing to cover the surgical site.
16005814|NCT02844569|Device|3D-collagen matrix|Subjects requiring tooth extraction will have the hopeless tooth extracted. The extraction socket treated with xenograft bone substitute will receive a 3D collagen matrix to cover the surgical site.
16005815|NCT02844556|Procedure|SMILE surgery|SMILE surgery and FS-LASIK surgery are both effective method for the correction of myopia and myopic astigmatism. They have been proved to offer many advantages in terms of visual acuity, corneal sensitivity and corneal biomechanics compared with traditional refractive surgeries.
16005816|NCT02844556|Other|FS-LASIK surgery|SMILE surgery and FS-LASIK surgery are both effective method for the correction of myopia and myopic astigmatism. They have been proved to offer many advantages in terms of visual acuity, corneal sensitivity and corneal biomechanics compared with traditional refractive surgeries.
16005817|NCT02844543|Device|EYE-SYNC eye-tracking device|The EYE-SYNC® portable eye-tracking system. The eye tracker is a handheld isolated display environment with embedded eye tracking sensors. The eye tracker is connected to a high-performance Windows tablet though a customized docking station. Included accessories with EYE-SYNC are a U.S. tablet power supply adapter and disposable sanitary masks. Participants are asked to follow a dot with their eyes, as the dot moves on the screen of the EYE-SYNC device.
16005818|NCT02844543|Other|SCAT-3|The Symptom subtest of SCAT-3 assessment tool will be administered to participants.
16005819|NCT02844543|Device|Desktop Eye-Tracker|Eye movements are recorded with an eye tracking system (Desktop Eye-Tracker, Eyelink CR, SR Research) with up to 1000 Hz temporal resolution. The target stimulus is presented on a computer screen approximately 50 cm from the participant. Participants are asked to follow a dot with their eyes, as the dot moves on the monitor screen of the desk-top eye-tracking device.
16005820|NCT02844530|Drug|90Y-epratuzumab tetraxetan|"The Primary objective is to compare the complete response rate (CR + CRp) after 2 injections of 370 MBq/m² of 90Y-epratuzumab tetraxetan RIT at day 1 and day 8 versus standard of care salvage chemotherapy regimens in adult CD22+ relapsed/refractory B-ALL.
~A second RIT cycle (consolidation) will be allowed in the experimental group in case of response (CR or CRp).
~From an ethical point of view, it will be also permitted to propose the RIT experimental treatment in the control group in case of treatment failure or relapse during the 6 months following inclusion. Follow-up will be also 12 months from the RIT for these patients"
16005821|NCT02844530|Drug|chemotherapy/ immunotherapy|
16005822|NCT02844517|Device|Artificial Pancreas|Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump and continuous glucose monitor. This AP system is designed to help control blood sugar in people living with type 1 diabetes.
16005823|NCT02844504|Behavioral|Low Intensity Exercise Training 1|Subjects will perform handgrip exercise training at low intensity (20% maximal force) 5 times a week for 6 weeks (more details not provided to keep study blinded)
16005824|NCT02844504|Behavioral|Low Intensity Exercise Training 2|Subjects will perform a different handgrip exercise training at low intensity (20% maximal force) 5 times a week for 6 weeks (more details not provided to keep study blinded)
16005825|NCT02844491|Other|additional biological samples|blood and tissue samples
16005826|NCT02844478|Behavioral|SBP English|The SBP caregiver intervention has been successfully delivered and disseminated in the US. It is currently offered in 9 states and 16 Texas counties . The SBP is designed to a) improve the QoL of family caregivers who provide care for people with ADRD and b) help caregivers manage their stress and cope better with their lives. The SBP is implemented using a Master Trainer/Group Facilitator (lay leader) model. The SBP is a multi-component intervention that meets for 90 minutes once a week for 9 consecutive weeks.
16005827|NCT02844478|Behavioral|SBP SPANISH|The SBP caregiver intervention has been successfully delivered and disseminated in the US. It is currently offered in 9 states and 16 Texas counties . The SBP is designed to a) improve the QoL of family caregivers who provide care for people with ADRD and b) help caregivers manage their stress and cope better with their lives. The SBP is implemented using a Master Trainer/Group Facilitator (lay leader) model. The SBP is a multi-component intervention that meets for 90 minutes once a week for 9 consecutive weeks. The Spanish translation and cultural adaptation of the SBP has been completed under the direction of the PI.
16071152|NCT02374567|Drug|Fluvoxamine|
16005828|NCT02844465|Device|Visualase MRI-Guided Laser Ablation|All subjects will undergo MRI-guided laser ablation of the amygdala and hippocampus with the Visualase System.
16005829|NCT02844452|Device|Acupuncture|Acupuncture is a form of alternative medicine and a key component of traditional Korean medicine (TKM) involving thin needles inserted into the body at acupuncture points. It can be associated with the application of heat, pressure, or laser light to these same points. Acupuncture is commonly used for pain relief, though it is also used for a wide range of other conditions. Clinical practice varies depending on the country.
16005830|NCT02844452|Device|Sham Acupuncture|Sham acupuncture is used as a control in scientific studies that test the efficacy of acupuncture in the treatment of various illness or disorders. In an ideal controlled study, subjects would not know whether they were getting true or sham acupuncture. We are going to use Park Sham Acupuncture, which is composed of sham acupuncture needle not penetrating the skin of subjects and Park sham acupuncture device attacted on the subject's skin in order to block the seeing whether the acupuncture needle penetrates skin or not.
16005831|NCT02844439|Drug|Tesevatinib|
16005832|NCT02844426|Drug|bifid triple viable capsule and pectin|
16005833|NCT02844426|Drug|maltodextrin|
16005834|NCT02844413|Other|aerobic interval training|In the first group (G1), aerobic interval training (AIT) was undertaken for 5 months (40 professional AIT sessions performed two times per week in 50 minute sessions) and followed a specially developed program. The second control group (G2), did not attend any training sessions but received medical advice on how to maintain physical activity as outlined by JNC hypertension guidelines
16005835|NCT02844400|Device|Biometric Devices|Patients will wear two devices: HealthPatch Sensor and Phillips Actiwatch. Health data (e.g. average steps per day, resting heart rate) will be collected and monitored over the course of a cycle of cytotoxic chemotherapy.
16005836|NCT02844400|Other|Physical Performance Testing|Patients will complete a CPET and 6 minute walk test within one week of starting an upcoming chemotherapy cycle and they will undergo a second CPET upon completion of said chemotherapy cycle.
16005837|NCT02844387|Dietary Supplement|L-arginine hydrochloride solution|Patients with unresectable brain metastases from solid tumors that are candidates from twice-daily fractionated radiation therapy will be randomized to receive either oral arginine supplementation one-hour prior to each fraction of radiation. Radiation therapy consist in whole-brain treated by two lateral fields to a total dose of 32 Gy in 20 fractions of 1.6 Gy each two times a day with a 6 hours interval between treatments (10 days), followed by a 22.4 Gy boost over the evident lesions with the same fractionation schedule (7 days). The spinal cord dose will be limited to 40 Gy
16005838|NCT02844387|Other|Placebo|Patients with unresectable brain metastases from solid tumors that are candidates from twice-daily fractionated radiation therapy will be randomized to receive oral placebo one-hour prior to each fraction of radiation. Radiation therapy consist in whole-brain treated by two lateral fields to a total dose of 32 Gy in 20 fractions of 1.6 Gy each two times a day with a 6 hours interval between treatments (10 days), followed by a 22.4 Gy boost over the evident lesions with the same fractionation schedule (7 days). The spinal cord dose will be limited to 40 Gy
16005839|NCT02844374|Other|Functional stereotaxic exploration|Visual analysis : in order to define the level of cortical resections. Epileptogenic maps : calculated for each crisis and for all crisis in general. Connectivity maps : calculated for each site stimulated at low-frequency. Post-operative evaluation : in order to assess the extent of resection.
16005840|NCT02844361|Other|autologous stem cell transplantation|Patients in this group will receive BEAC(BCNU+VP-16+CTX+Ara-c) as conditioning regimen and then with autologous stem cells feedback
16005841|NCT02844361|Other|conventional chemotherapy|Patients in this group will receive previously effective chemotherapeutic regimen as consolidation therapy
16005842|NCT02844348|Other|Hypnosis session|
16005843|NCT02844335|Device|Cryosurgery|Argon-helium cryosurgical system (percutaneous ablation under CT or ultrasound guidance)
16005844|NCT02844335|Biological|NK immunotherapy|Natural killer cell (each treatment: about 10 billion cells transfusion in 3 times, i.v.)
16005845|NCT02844322|Drug|Bortezomib|compare the efficiency of bortezomib and rituximab in Waldenström macroglobulinemia
16005846|NCT02844322|Drug|Rituximab|compare the efficiency of bortezomib and rituximab in Waldenström macroglobulinemia
16005847|NCT02844309|Drug|Thalidomide|thalidomide 50-150 mg per night
16005848|NCT02844296|Behavioral|Video about exercise|Video about short-bout exercise will be played for the participants.
16005849|NCT02844296|Behavioral|App about exercise|A smartphone App about exercise will be installed in participants' mobile phone.
16005850|NCT02844296|Behavioral|Leaflet about exercise|A leaflet about exercise will be provided for the participants.
16005851|NCT02844296|Behavioral|Video about diet|Video about healthy diet will be played for the participants.
16005852|NCT02844296|Behavioral|App about diet|A smartphone App about healthy diet will be installed in participants' mobile phone.
16005853|NCT02844296|Behavioral|Leaflet about diet|A leaflet about healthy diet will be provided for the participants.
16005854|NCT02844283|Drug|Ad-HGF|
16005855|NCT02844283|Other|0.9% NaCl|
16005856|NCT02844270|Device|Rapamycin Drug-Eluting Bioresorbable Coronary Stent System|Implantation of the Rapamycin Drug-Eluting Bioresorbable Coronary Stent System
16005857|NCT02844244|Behavioral|training group|The training workshop included two two-hour sessions. It focused on the enhancement of knowledge, attitude, and practice of peer health promoters on implementing community activities for the residents.
16005858|NCT02844231|Other|Single-photon emission computed tomography|
16005859|NCT02844218|Other|Age of patient|"Historical Comparison Between Patients Aged 60 to 69 and Patients Aged ≥ 70 Years Treated With Intensive Chemotherapy.
~Comparison between Intensive Chemotherapy and Low-Intensity Treatments in Patients Aged ≥70 Years.
~Improvement of Treatments Over Time
~Overall Survival (OS) of patients aged ≥ 70 Years during3 study periods. Period 1, from 1985 to 1999, during which all patients with acute Myeloid Leukemia received an intensive chemotherapy regimen at the University Hospital. Period 2, from 2000 to 2006, during which all patients received an Intensive Chemotherapy regimen, Improved Supportive Care and follow-Up protocol at the University Hospital. Period 3, From 2007 to 2014, during Which patients received Improved Supportive Care and follow-up protocol at the University Hospital and Personalized Therapy (Intensive Chemotherapy or Low-Dose Intensity Treatment)"
16006071|NCT02842554|Drug|Drug Placebo Administration|
16005860|NCT02844205|Other|quotation of the newborn behavioral observation scale|quotation of the newborn behavioral observation scale by 12 experimented nurses. Patient will be filmed during an usual care and nurses will quote the scale thanks to the video.
16005861|NCT02844179|Drug|HTBZ|
16005862|NCT02844166|Other|viscoelastic surface support|Patients will be placed in an ICU bed with viscoelastic surface support
16005863|NCT02844166|Other|pyramidal foam surface support|Patients will be placed in an ICU bed with pyramidal foam surface support
16005864|NCT02844153|Other|modalities of metformin prescription|Metformin prescription or not, in each CKD stage
16005865|NCT02844140|Procedure|DE-CT's and SE-CT|Patients included in the trial will receive 3 extra DE-CT's and 3 extra SE-CT's
16005866|NCT02844127|Procedure|Implantable Cardioverter Defibrillator (ICD)|Patients will receive an Implantable Cardioverter Defibrillator (ICD), with the leads implanted in either the apex or the septum as the first location. After defibrillation threshold is determined, the leads position will be changed to the second location and DFT will be determined again.
16005867|NCT02844114|Drug|Ganoderma lucidum spore|G 300mg, 5 tablets by mouth
16005868|NCT02844114|Drug|Placebo|Sugar pill manufactured to mimic tramadol 1500mg tablet
16005869|NCT02844114|Drug|Chemotherapy|iv.30 minutes
16005870|NCT02844101|Device|GT3X Actigraph accelerometer.|
16005871|NCT02844088|Other|Meningococcus C conjugate vaccine|
16005872|NCT02844075|Drug|MK-3475(pembrolizumab)|"Neo-adjuvant chemoradiation period:The treatment consisted of taxol, carboplatin, pembrolizumab and radiation. The radiation treatment comprises 44.1Gy (2.1Gy/Fr, total 21Fr) and that will be about 5 weeks. Intensity modulated RT (IMRT) or 3D CRT (three-dimensional conformal radiotherapy) will be allowed.
~Surgery:Before surgery, abdomen/chest CT scan, endoscopic ultrasound (EUS), and gastroscopy with biopsy will be done. Surgery should be done within 12 weeks after last neo-adjuvant treatment.
~Adjuvant period:Adjuvant treatment with pembrolizumab 200mg every 2week (maximum 2 years) should be performed within 8 weeks after surgery (recommended period : 3-6 weeks after surgery). Gastroscopy and abdomen/chest CT scan will be performed at 6 month after surgery."
16005873|NCT02844062|Biological|anti-EGFRvIII CAR T cells|CAR T cells are infused intravenously to patients in a three-day split-dose regimen（day0,10%; day1, 30%; day2, 60%）with a total targeted dose.
16005874|NCT02844062|Drug|cyclophosphamide|250 mg/m^2 d1-3
16005875|NCT02844062|Drug|Fludarabine|25mg/m^2 d1-3
16005876|NCT02844049|Device|Deep Brain Stimulation|surgical procedure
16005877|NCT02844036|Procedure|Percutaneous angioplasty|
16005878|NCT02844036|Procedure|Balloon angioplasty|
16005879|NCT02844036|Procedure|Right heart catheterization|
16005880|NCT02844036|Procedure|Echocardiography|
16005881|NCT02844036|Other|A six-minute walking test|
16005882|NCT02844036|Procedure|Functional respiratory investigations|
16005883|NCT02844036|Procedure|Pulmonary tomography or pulmonary angiography|
16005884|NCT02844036|Other|Biological parameters|
16005885|NCT02844023|Behavioral|Clinical evaluation|With questionnaire.
16005886|NCT02844023|Other|Paraclinical evaluation|Symptom inflammatory, biomarkers.
16005887|NCT02844023|Device|Imaging|Thoraco-abdominal scanner injected or PET scanner if contraindication for scanner.
16005888|NCT02844023|Other|Ophthalmologic examination|
16005889|NCT02844023|Biological|Dosage of biomarkers|Control patients.
16005890|NCT02844010|Other|weighing|
16005891|NCT02843997|Genetic|Endophenotype and sequencing|Draw an endophenotype and genetic study
16005892|NCT02843984|Drug|Lactoferrin|
16005893|NCT02843971|Device|Intraocular pressure measurement with the Sensimed triggerfish Device|
16005894|NCT02843958|Device|HEMOPTIC|
16005895|NCT02843945|Device|Directional Brachytherapy Source Implant|The FDA Cleared CivaSheet Directional Pd103 Brachytherapy Source is a planar radiaiton source which utilizes gold shielding in its construction. This device is radioactive on one side only, and is capable of safely delivering high doses of radiation to target areas even when placed directly adjacent to sensitive, healthy tissue or critical structures.
16005896|NCT02843932|Other|functional brain MRI|functional imagery during motor-perception tasks
16005897|NCT02843919|Other|Electroencephalography and Electrocardiography|
16005898|NCT02843906|Procedure|Lombar Punction|cerebrospinal fluid testing at screening and M36
16005899|NCT02843906|Radiation|Magnetic Resonance Imaging (MRI)|MRI done at screening and M36
16005900|NCT02843906|Radiation|Positron-Emission Tomography (TEP) /(FDG)|TEP/FDG done at screening and M36
16005901|NCT02843906|Other|Psychiatric tests|
16005902|NCT02843906|Other|Neuropsychological Tests|done at screening, M12, M24 and M36
16005903|NCT02843906|Genetic|Apolipoprotein (ApoE) detection|ApoE detection done at screening
16005904|NCT02843893|Device|Measure the minimum intensity of a painful stimulation|With Neurolight device.
16005905|NCT02843867|Other|blood sample|36 ml of blood sample at D0 and 1 year after transplantation
16005906|NCT02843841|Other|Blood and fecal sample.|Blood (28 ml) and fecal sample at day 0, 4 days, 3 months and one year after transplantation
16005907|NCT02843828|Device|gait rehabilitation with Samsung Hip Assist v1|Participants will participate in 10 sessions of gait rehabilitation with Samsung Hip Assist v1 (5sessions-treadmill gait training / 5sessions-overground gait training), 30min per session
16005908|NCT02843828|Other|gait rehabilitation without Samsung Hip Assist v1|Participants will participate in 10 sessions of gait rehabilitation without Samsung Hip Assist v1 (5sessions-treadmill gait training / 5sessions-overground gait training), 30min per session
16005909|NCT02843815|Device|Cryosurgery|Argon-helium cryosurgical system (percutaneous ablation under CT or ultrasound guidance)
16005910|NCT02843815|Biological|NK Immunotherapy|Natural killer cell (each treatment: about 10 billion cells transfusion in 3 times, i.v.)
16005911|NCT02843802|Device|Cryosurgery|Argon-helium cryosurgical system (percutaneous ablation under CT or ultrasound guidance)
16005912|NCT02843802|Biological|NK Immunotherapy|Natural killer cell (each treatment: about 10 billion cells transfusion in 3 times, i.v.)
16005913|NCT02843789|Drug|Tocilizumab|
16005914|NCT02843776|Other|Questionnaires completion|
16005915|NCT02843763|Other|Blood sample|Blood sample (28 ml)
16006072|NCT02842554|Other|C|No Intervention
16005916|NCT02843750|Behavioral|Inspiratory Muscle Training-Rehabilitation|"The training will include the following components:
~Breathing Awareness
~Upper and Lower Extremity Exercise.
~Instructions for Inspiratory Muscle Training (IMT) performed using the PFlex valve
~Practice at home"
16005917|NCT02843750|Other|Questionnaires|Patient quality of life will be measured using patient-reported outcomes measurement information system (PROMIS) global items. Patients will also complete the Chronic Respiratory Questionnaire (CRQ) and the Medical Research Council Dyspnea Scale (MCR).
16005918|NCT02843737|Other|Polysomnography under spontaneous breathing|Patient will come to the sleep laboratory to perform the polysomnography under spontaneous breathing prescribed by the clinician
16005919|NCT02843724|Other|Naturopathic Care|Naturopathic diabetes care will be selected from a pre-approved menu. Participants' other health concerns will be addressed at naturopathic doctors' discretion
16005920|NCT02843724|Other|Usual (Conventional) Care|2016 Canadian Diabetes Clinical Practice Guidelines (self-management, blood-glucose-lowering, vascular protection, pharmacotherapy) will be implemented
16005921|NCT02843711|Genetic|Sequencing|Tumour samples are coming from routine histopathological procedure. They are used with consent of the patients. Genomic DNA extraction is performed from paraffin-embedded formalin-fixed (FFPE) tumour samples of lung adenocarcinoma. The genomic DNA mutations are identified by mass spectrometry array (Sequenom) using the LungCarta Panel. This panel could identify 214 mutations among 26 oncogenes.
16005922|NCT02843698|Drug|Dexmedetomidine|Dexmedetomidine infusion was previously reported to improve oxygenation and lung dynamics in patients with obstructive lung diseases. In our study we are going to investigate its effect on oxygenation and lung dynamics in restrictive lung disease
16005923|NCT02843698|Drug|Normal saline|Normal saline
16005924|NCT02843685|Drug|Drotrecogin alfa activated|
16005925|NCT02843672|Procedure|Triple Weil´s Osteotomy|"A 10mm longitudinal incision is made with a No.15 blade in the second intermetatarsal space immediately behind the dorsal interdigital fold, parallel to the extensor tendon. An intra-articular osteotomy in the metatarsal head is performed angled 45º relative to the long axis of the metatarsal and in a dorsal-distal to proximal-plantar direction. A second osteotomy is performed perpendicular to the metatarsal shaft,.The osteotomy is fastened with a 2.0mm snap-off screw.
~Once all the osteotomies are completed, the incisions are closed with a 2/0 monofilament suture."
16005926|NCT02843672|Procedure|Distal metatarsal minimally invasive osteotomy|A 5mm longitudinal incision is made with a MIS blade No.64 in the intermetatarsal space immediately behind the dorsal interdigital fold, parallel to the extensor tendon. Under fluoroscopy vision, an extra-articular osteotomy in the metatarsal neck is performed angled 45º relative to the long axis of the metatarsal and in a dorsal-distal to proximal-plantar direction. The osteotomies scheduled preoperatively are performed, repeating the same procedure for each ray needing an osteotomy. Once all are completed, the incisions are closed with a 4/0 monofilament suture.
16005927|NCT02843659|Drug|BMS-931699|Specified dose on specified days
16005928|NCT02843659|Drug|BMS-986142|Specified dose on specified days
16005929|NCT02843659|Drug|Placebo|Specified dose on specified days
16005930|NCT02843646|Device|Walk Aide training|
16005931|NCT02843633|Device|BioFreedom™ Drug Coated Coronary Stent System|a non-surgical procedure that uses a catheter to place a stent to open up coronary arteries that have been narrowed by atherosclerosis
16005932|NCT02843633|Drug|Antiplatelet Drug|Dual antiplatelet therapy for one month followed by single antiplatelet therapy indefinitely. Aspirin and clopidogrel (or other P2Y12 inhibitor) will be used and dosing is according to standard institutional practice
16005933|NCT02843620|Dietary Supplement|b-2Cool|b-2Cool® is native type II collagen extracted from chicken sternums
16005934|NCT02843620|Other|Placebo|Excipients only
16005935|NCT02843607|Device|Cryosurgery|Argon-helium cryosurgical system (percutaneous ablation under CT or ultrasound guidance)
16005936|NCT02843607|Biological|NK immunotherapy|Natural killer cell (each treatment: about 10 billion cells transfusion in 3 times, i.v.)
16005937|NCT02843594|Procedure|LEEP intervention|Low Energy Endosafe Phaco (LEEP) with micro-interventional lens fragmentation
16005938|NCT02843594|Procedure|Standard Phaco Control|
16005939|NCT02843581|Device|Cryosurgery|Argon-helium cryosurgical system
16005940|NCT02843581|Biological|NK immunotherapy|Nutral killer cell immunotherapy for more than 6 times
16005941|NCT02843568|Other|Laboratory Biomarker Analysis|Correlative studies
16005942|NCT02843568|Radiation|Standard fractionation|60-66y Gy delivered in 1.8-2.0 Gy fractions over 30-36 treatments
16005943|NCT02843568|Radiation|Stereotactic Body Radiation Therapy (SBRT)|40-60 Gy delivered in 5-20 Gy fractions over 3-8 treatments
16005944|NCT02843568|Procedure|Four Dimensional Computed Tomographic Imaging (4DCT)|Subjects undergo a total of 7 research-ordered four dimensional computed tomographic imaging (4DCT) scans: 1 at simulation, and 2 scans at each of the 3 post-radiation therapy time points (3, 6, and 12 months). 4DCT determines lung tissue elasticity and for standard of care radiation treatment planning.
16005945|NCT02843542|Device|PET-MR|Patients with Hyperthyroidism and surgery indication will be recruited and directed to imagine exams. In addition to the conservative 99mTc-MIBI and US, patients will also undergo 18FCH PET/MRI for detecting adenomas and their location.
16005946|NCT02843542|Device|PET-CT|Patients with Hyperthyroidism and surgery indication will be recruited and directed to imagine exams. In addition to the conservative 99mTc-MIBI and US, patients will also undergo PET-CT for detecting adenomas and their location.
16005947|NCT02843529|Other|Altoida: neuropsychological, MRI, EEG and CSF biomarkers|"Data collection at baseline: clinical (neurological, activity of the daily life, instrumental activity of the daily life, depression scale), standard neuropsychological exam, ALTOIDA and neurophysiology (EEG/ERPs) in both Prodromal and Preclinical AD subjects. In both Prodromal and Preclinical AD subjects, APOE genotyping. The local clinical Unit should document the positivity at the baseline session of at least one of the biomarkers of AD mentioned above.
~Data collection at 6, 12, 24 and 36 months of follow up: clinical (neurological, activity of the daily life, instrumental activity of the daily life, depression scale), standard neuropsychological exam, ALTOIDA and neurophysiology (EEG/ERPs) in both Prodromal and Preclinical AD subjects."
16005948|NCT02843516|Other|No intervention|No intervention
16005991|NCT02843126|Biological|NK immunotherapy|For each procedure, 10 billion cells will be infused for 4 times
16006073|NCT02842541|Drug|EBI-031|
16005949|NCT02843503|Device|Arterialized-venous reference (YSI)|All patients will be fitted with the a CGM system, Dexcom G5 Mobile, patients receive an iv-catheter to sample venous blood. The samples will be arterialized using a heated-hand-box (arterialized-venous reference (YSI). Blood will be drawn for the determination of glucose concentrations using arterialized-venous sampling techniques per YSI.
16005950|NCT02843503|Device|Venous reference measurement (YSI)|All patients will be fitted with the a CGM system, Dexcom G5 Mobile, patients receive an iv-catheter to sample venous blood. Blood will be drawn for the determination of glucose concentrations using venous sampling techniques measured per YSI.
16005951|NCT02843503|Device|Capillary reference (SMBG)|All patients will be fitted with the a CGM system, Dexcom G5 Mobile, patients receive vingerstick measurements to sample capillary blood measured per Self Monitoring of Blood Glucose (SMBG) device.
16005952|NCT02843490|Drug|Ranibizumab|Three injections (o.5 mg Ranibizumab) within the first three months is followed by an individual therapy interval based on the clinical progress (PRN)
16005953|NCT02843477|Device|ultrasonographic measurement of corrected flow time in carotid artery|Corrected carotid artery flow time is measured using 10-5 MHz linear probe on a portable ultrasound machine. On the two-dimensional image, the optimal image of the long-axis view is obtained at the left common carotid artery. The sample volume is placed on the center of the lumen, 2 cm proximal to the bulb, and a pulsed wave Doppler examination was performed while the Doppler beams were adjusted to ensure < 60° of angle for the best signal. Then, cardiac cycle time and carotid flow time is measured. Carotid flow time is measured between the upstroke of the flow tracing and the dicrotic notch, and it is corrected for pulse rate by dividing flow time by the square root of the cardiac cycle time to calculate corrected carotid artery flow time (flow time/√cycle time).
16005954|NCT02843464|Other|reported remote ischemic preconditioning (RIPC)|Three five-minute cycles of upper limb ischaemia and three five-minute pauses using a blood pressure cuff inflated to 200 mmHg.
16005955|NCT02843451|Drug|Milk Thistle|
16005956|NCT02843451|Drug|Placebo|
16005957|NCT02843438|Other|Fluorescein angiography|
16005958|NCT02843438|Other|Dilated fundus examination|
16005959|NCT02843438|Biological|Toxoplasmosis serology|
16005960|NCT02843438|Drug|Anti-toxoplasmosis treatment|
16005961|NCT02843438|Drug|Anti-inflammatory treatments|
16005962|NCT02843438|Other|Puncture in anterior chamber|
16005963|NCT02843425|Other|Regular Diet|Participants follow their normal diet (not including beans for 8 weeks)
16005964|NCT02843425|Other|Navy Beans (Canned)|Participants add 1/2 cup of canned beans per day to their diets for the first 2 weeks. This is increased to 1 cup per day for the following 6 weeks of the study.
16005965|NCT02843412|Procedure|choose two tumor tissue paraffin blocks|
16005966|NCT02843386|Drug|Adjuvant chemotherapy by Fotemustin|"Fotemustin is given for 6 cycles :
~One Induction cycle: Fotemustin 100 mg/m², 1 hour IV infusion, D1D8D15, 5 week rest period, restart on D50.
~Five Maintenance cycles: Fotemustin 100 mg/m², 1 hour IV infusion, D1-D21."
16005967|NCT02843386|Other|Intensive surveillance|"Intensive surveillance
~Total duration: 3 years.
~liver functional tests/3 months, - liver MRI or CT-scan/6 months, - whole body CT-scan/12 months."
16005968|NCT02843373|Device|TMS|
16005969|NCT02843347|Procedure|Blood draw|Three tubes of blood (28.5 mL in total) will be obtained at the Baseline Visit. The sample will be stored for future research.
16005970|NCT02843334|Biological|Dried blood spot (DBS) sampling|DBS be collected during a hemodialysis session and deposited on an anonymized blotting paper. Laboratory ARCHIMED Life Science GmbH, based in Austria will perform all the biological analysis. For the diagnosis, men will have a measure of the alpha-galactosidase activity level, whereas screening in women will be established on the association of alpha-galactosidase activity and lyso-GB3 analyses. If results are compatible, genetic mutation will be searches in order to confirm the diagnosis for women.
16005971|NCT02843321|Biological|T-cell infusion, influenza vaccination|Donor derived infection-specific T-cells (with activity against CMV,adenovirus, EBV, VZV, Influenza, BKV and Aspergillus) and vaccination (with Fluvax)
16005972|NCT02843308|Behavioral|Facilitated group therapy with behavioral practice; 18 weeks|Facilitated group therapy for hoarding disorder with behavioral practice
16005973|NCT02843295|Other|blood samples|
16005974|NCT02843282|Behavioral|Advanced Reasoning Training|This is a strategy-based intervention to enhance frontal lobe function. Strategies equip participants to improve their strategic attention, integrated reasoning, and innovation abilities.
16005975|NCT02843269|Behavioral|Multi-component lifestyle intervention|The exact same intervention was given to the three Stepped-wedge groups - but each of the three groups were started up three months apart. The waiting groups served as control groups. Thus, the intervention were for all three groups a multi-component intervention consisting of Intelligent Physical Exercise training (IPET), Dietary Advice and Weight loss (DAW) and Cognitive Behavioral Therapy (CBT)
16005976|NCT02843256|Device|Isomark Canary|The Isomark Canary will analyze the exhaled air and generate a breath delta value.
16005977|NCT02843230|Radiation|Avastin|
16005978|NCT02843230|Radiation|Lomustine|
16005979|NCT02843230|Radiation|Temozolomide|
16005980|NCT02843230|Device|MRI|
16005981|NCT02843230|Device|MRS|
16005982|NCT02843230|Device|DSC|
16005983|NCT02843217|Behavioral|Lifestyle, screening|
16005984|NCT02843204|Drug|Pembrolizumab|Patients received i.v. pembrolizumab (10 mg/kg) on day 1 of a 21-day cycle, until disease progression, discontinuation due to unacceptable toxicity, withdrawal of consent or study closure
16005985|NCT02843204|Biological|NK immunotherapy|Each treatment: about 10 billion cells in all, infusion in 3 times, i.v.
16005986|NCT02843191|Drug|Chemotherapy|5-FU, Leucovorine, and Oxaliplatin (FOLFOX regimen)
16005987|NCT02843178|Behavioral|Vouchers|A voucher is given that can be used at the cashier of participating grocery stores, corner stores, and farmer's markets, enabling a participant to have the voucher's value subtracted from their grocery bill.
16005988|NCT02843165|Drug|CBI|Approved CBIs (including anti-CTLA-4 and anti-PD-1/PD-L1 antibodies)
16005989|NCT02843165|Radiation|CBI plus SBRT|SBRT at 28.5 Gy (9.5 Gy x3 fractions) will be delivered within 1 - 21 days of the start of Cycle 1 of the CBI plus CBI (approved CBIs including anti-CTLA-4 and anti-PD-1/PD-L1 antibodies)
16005990|NCT02843126|Drug|Trastuzumab|Pre-dose (0 hours) on Day 1 of Cycles 1 to 8 (cycle length of 21 days)
16005992|NCT02843113|Behavioral|4 Your Child Program|Integrates the provision of responsible parenting, economic stability, and relationship education services to fathers at risk for paternal disengagement.
16005993|NCT02843100|Other|Modified Exclusive Enteral Nutrition|Two weeks of Exclusive Enteral Nutrition with Modulen
16005994|NCT02843100|Other|Crohn's Disease Exclusion Diet|a limited whole food diet
16005995|NCT02843100|Other|Partial Enteral Nutrition|25-50% of Energy from formula
16005996|NCT02843100|Other|Standard Exclusive Enteral Nutrition|8 weeks of Exclusive Enteral Nutrition
16006001|NCT02843061|Drug|Rituximab|
16006002|NCT02843061|Biological|NK immunotherapy|Each time 10 billion cells, 4 times in all,i.v.
16006003|NCT02843048|Behavioral|Exercise training program|"Participants allocated to the Exercise training plus standard medical care group will undergo an exercise-training program of 11 months duration, 3 sessions/week, and 60 minutes/session, starting one month after the surgery. Each exercise session will be supervised and will include 5 major components: i) warm-up, ii) multidirectional jumps, iii) balance, iv) strength and, v) cool down. This structure is planned to meet two main objectives: i) enhance bone formation and, ii) reduce fall risk by improving muscle strength, cardiorespiratory fitness and balance."
16006004|NCT02843048|Behavioral|Standard medical care|Standard follow-up medical care following bariatric surgery
16006005|NCT02843035|Drug|venglustat (GZ402671)|"Pharmaceutical form: tablet or capsule
~Route of administration: oral"
16006006|NCT02843035|Drug|imiglucerase|"Pharmaceutical form: sterile lyophilized product
~Route of administration: intravenous"
16006007|NCT02843022|Behavioral|standardized electronic messages|supportive and educational short messages
16006008|NCT02843022|Behavioral|nurse phone call if requested|"If participant responds yes to an offer for a phone call, a nurse calls them within a week of this response"
16006009|NCT02843022|Behavioral|Staff nurse phone follow-up|Usual care: hospital nurse or lactation consultant calls patient within 2-3 weeks prior to discharge. Message left if patient is not reached.
16006010|NCT02843009|Behavioral|Resistance Exercise Training|Resistance exercise will involve 2 sessions per week for 18 weeks. Each session will involve participants carrying out the following exercises: calf press, leg press, leg extension and leg curl
16006011|NCT02843009|Dietary Supplement|Supplementation|Participants randomised to either 3g/day of fish oil or safflower oil for 18 weeks
16006012|NCT02842983|Drug|Esmolol|conventional management plus esmolol infusion
16006013|NCT02842957|Behavioral|Lifestyle Intervention|Patients randomized to the lifestyle group will be given individual counseling regarding the implementation of a plant based diet. They will also be given a home based exercise program to complete. Patients will be assisted with the optimal use of their prescription medications and they will receive specific counseling regarding strategies to help them successfully change their behavior.
16006014|NCT02842944|Device|open loop weaning group (Beacon)|mechanical ventilation following advice from the Beacon Caresystem
16006015|NCT02842944|Other|Routine care|Standardized routine care
16006016|NCT02842931|Drug|R-DA-EPOCH-21|R-DA-EPOCH-21 treatment without auto-SCT for DLBCL patients younger than 60 years with intermediate and high risk for IPI
16006017|NCT02842931|Drug|R-DA-EPOCH-21 + auto-SCT|R-DA-EPOCH-21 treatment with auto-SCT for DLBCL patients younger than 60 years with intermediate and high risk for IPI
16006018|NCT02842931|Drug|R-mNHL-BFM-90|R-mNHL-BFM-90 without auto-SCT in patients with DLBCL under the age of 60 years with intermediate and high risk for IPI
16006019|NCT02842931|Drug|R-mNHL-BFM-90 + auto-SCT|R-mNHL-BFM-90 with auto-SCT in patients with DLBCL under the age of 60 years with intermediate and high risk for IPI
16006020|NCT02842918|Procedure|Spinal Manual Therapy|
16006021|NCT02842918|Procedure|Spinal Range of Motion|
16006022|NCT02842905|Other|Fitting Audiologist completion|Phase II of the COSI (Client Oriented Scale of Improvement) questionnaire completed in a scheduled visit with the fitting Audiologist
16006023|NCT02842905|Other|Participant's Physician completion|Phase II of the COSI (Client Oriented Scale of Improvement) questionnaire completed in a scheduled visit with the Participant's Physician
16006024|NCT02842892|Other|Tissue stiffness|
16006025|NCT02842879|Other|Outpatient Foley cervix priming|Outpatient setting for cervix priming with Foley catheter
16006026|NCT02842866|Biological|Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine|0.5 milliliter (mL), Intramuscular (IM), single dose on Day 0.
16006027|NCT02842866|Biological|Meningococcal Polysaccharide Vaccine, Groups A, C, Y, and W-135 Combined|0.5 mL, Subcutaneous (SC), single dose on Day 0.
16006028|NCT02842853|Biological|Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine|0.5 mL, Intramuscular
16006029|NCT02842853|Biological|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine|0.5 mL, Intramuscular
16006030|NCT02842840|Behavioral|Patient-based intervention|
16006031|NCT02842840|Behavioral|Family based intervention|
16006032|NCT02842840|Other|Routine counseling|
16006033|NCT02842827|Drug|IMG-7289|LSD1 inhibitor
16006034|NCT02842827|Drug|All-trans retinoic acid|Derivative of Vitamin A, differentiating agent.
16006035|NCT02842814|Other|Drug free|Both Glucocorticoid(GC) and hydroxychloroquine(HCQ) treatment are stopped in stable SLE patients.
16006036|NCT02842814|Drug|HCQ|Glucocorticoid(GC) treatment is stopped in stable SLE patients. Hydroxychloroquine (HCQ) is kept as 0.2-0.4g/d
16006037|NCT02842814|Drug|GC+HCQ|Glucocorticoid(GC) is kept no more than 7.5mg/d. Hydroxychloroquine (HCQ) is kept as 0.2-0.4g/d.
16006038|NCT02842801|Other|Hip manipulation|High-amplitude and low-velocity thrust mobilization
16006039|NCT02842788|Procedure|Prone positioning|Turning the patient face down for several consecutive hours
16006040|NCT02842775|Other|balance perturbation training|perturbation training on the split-belt balance perturbance treadmill,
16006069|NCT02842567|Drug|Placebo|This group will treated with 2 identical placebo pills daily given orally for 16 weeks.
16006070|NCT02842554|Other|EPT|
16071153|NCT02374567|Drug|Escitalopram|
16006041|NCT02842762|Device|Right ventricular epicardial pacing|The patient's own heart rate at that moment will be the starting point for the study. Right ventricle pacing will be instituted by selecting a rate that is 5 beats above the patient's own heart rate. We will use a stepwise approach where we increase the pacermaker's rate with steps of 5 beats until we have 100% capture of the pacemaker beats. After waiting for at least one minute of pacing we will obtain a set of measurements.
16006042|NCT02842762|Procedure|cardiac surgery|Elective cardiac surgery, with use of cardiopulmonary bypass.
16006043|NCT02842762|Device|3D TEE|Intraoperatively, all patients will be monitored by means of TEE
16006044|NCT02842762|Device|Pacemaker lead|All patients will have a epicardial pacemaker lead in situ.
16006045|NCT02842749|Drug|everolimus|Everolimus is taken at a starting dose of 10 mg orally once daily.Patients will be provided with adequate supply of study treatment for self-administration at home until at least their next scheduled study visit.All patients will be followed for adverse events and serious adverse events for 30 days following the last dose of study drug. Beyond these 30 days, any serious adverse events that are suspected to be related to the study drug will also be collected
16006046|NCT02842736|Device|Cerene(R) Cryotherapy Device|
16006047|NCT02842723|Radiation|Protontherapy|59,5 Gy (1,7 Gy daily, 5 fractions per week).
16006048|NCT02842710|Device|GeneXpert®|Detection is carried out after a sample within the patient's nasal cavity. The swab containing the sample is placed in the PLC GeneXpert® Cepheid . The analysis takes one hour . The results leave automatically.
16006049|NCT02842697|Procedure|HVPG measurement|HVPG obtained by means of catheterization of a hepatic vein with a balloon catheter
16006050|NCT02842697|Procedure|CTA|Three-dimensional hepatic vein-portal vein model constructed with CTA images
16006051|NCT02842697|Procedure|Doppler ultrasound|Portal vein velocity measured by Doppler ultrasound
16006052|NCT02842684|Device|TraumaCad software|restitution of anatomical- radiological parameters after total hip arthroplasty with TraumaCad , conventional planning systems and without planning.
16006053|NCT02842671|Other|Assigned Ambassador|If assigned to the intervention group, participants will be contacted by the assigned medical student ambassador at least 1 day prior to the procedure. A brief discussion will take place to review the child's history and survey results. The family will be met by the Ambassador at the hospital and stay with the family until the patient is in the post anesthesia recovery unit. The ambassador is expected to make accommodations for the child as determined by the accommodations survey results. The family will be required to allow the Ambassador to stay through check-in and the procedure.
16006054|NCT02842658|Other|A high-intensity interval exercise group|To avoid or reduce muscle soreness or cramps, adequate warm-up is suggested
16006055|NCT02842658|Other|An Attention-Control Group|Patients will be contacted weekly to access physical activity. To avoid or reduce muscle soreness or cramps, adequate warm-up is suggested
16006056|NCT02842632|Other|theoretical test|The theoretical test is a multiple choice test which consists of 50 questions with 1 point per question (max. 50 points). It will be done before the teaching, after the 2 teaching sessions and 3 Months after the study
16006057|NCT02842632|Other|practical test|The practical test is an evaluation of 11 basic perioperative TEE examination on the simulator (CAE Vimedix Simulator). Each view is evaluated on a scale of 0 to 10 according to predetermined criteria including image angle, overall clarity and visualization of 3 major anatomic structures pertinent to each view. Each view can receive a maximum score of 10 and each study a maximum of 109 (ME asc. aortic LAX has only 2 main structures). It will be done after the first and second teaching session, and 3 Months after the study.
16006058|NCT02842619|Biological|BonoFill-II|"Sinus augmentation - Surgery will be performed by either open or close sinus augmentation as per investigator discretion and as per common medical practice. After the elevation, BonoFill-II will be transplanted on the residual sub-antral bone.
~Bone grafting after removal of cysts from jaws - Treatment will be performed according to the size of the cyst: in relatively small cyst total enucleation will be performed. In large cysts, a process of marsupialization will be performed. The entire cyst will be removed, including the epithelium layer, and the BonoFill-II product will be used for filling."
16006059|NCT02842606|Other|Test meal|The two test meals are designed to have the same energy and macronutrient composition. They differ only in the carbohydrate source: fiber-enriched pasta or control pasta. Blood samples are taken at fasting and every 30 minutes over 4 hours. Fasting and postprandial intestinal fermentation is evaluated by breath test.
16006060|NCT02842593|Behavioral|Lower-repetition, heavier-load|8-12 reps/set at ~80% 1 repetition maximum
16006061|NCT02842593|Behavioral|Higher-repetition, lighter-load|20-25 reps/set at ~30% 1 repetition maximum
16006062|NCT02842580|Drug|5 FLUOROURACYL|"Folinic acid is administered IV at a dose of 400 mg/m² (or 200 mg/m² if Elvorine) as a 2 hr infusion.
~The 5FU bolus is administered in less than 10 minutes at 400 mg/m² (on D1). The continuous 5FU is administered IV at a dose of 2400 mg/m² over 46 hr (D1 and D2).
~The cycles will last 14 days. For this 1st line chemotherapy, the investigator has the choice of using capecitabine instead of LV5FU2; in this case the cycle lasts 21 days."
16006063|NCT02842580|Drug|acide folinique|200 mg/m² if Elvorine
16006064|NCT02842580|Drug|irinotecan|"Irinotecan is administered IV at a dose of 180 mg/m² over 90 minutes. Folinic acid is administered IV at a dose of 400 mg/m² (or 200 mg/m² if Elvorine) as an infusion over 2 hours, to be given in Y along with irinotecan.
~The 5FU bolus is administered in less than 10 minutes at 400 mg/m² (on D1). The continuous 5FU is administered IV at a dose of 2400 mg/m² over 46 hr (D1 and D2).
~The cycles will last 14 days."
16006065|NCT02842580|Drug|Oxaliplatin|"Oxaliplatin is administered IV at a dose of 85 mg/m² over 120 minutes. Folinic acid is administered IV at a dose of 400 mg/m² (or 200 mg/m² if Elvorine) as an infusion over 2 hours, to be given in Y along with oxaliplatin.
~The 5FU bolus is administered in less than 10 minutes at 400 mg/m² (on D1). The continuous 5FU is administered IV at a dose of 2400 mg/m² over 46 hr (D1 and D2).
~The cycles will last 14 days."
16006066|NCT02842580|Drug|capécitabine|For this 1st line chemotherapy, the investigator has the choice of using capecitabine instead of LV5FU2; in this case the cycle lasts 21 days.
16006067|NCT02842580|Drug|bevacizumab|Bevacizumab is administered IV at a dose of 5 mg/kg over 90 min at cycle 1, then 60 min at cycle 2 and 30 min in subsequent cycles. Bevacizumab is administered every 2 weeks before the start of chemotherapy
16006068|NCT02842567|Drug|Hydroxytyrosol plus Vitamin E|This group will treated with 2 pills daily, each containing 3.75 mg of hydroxytyrosol plus 5 mg of Vitamin E, given orally for 16 weeks
16006074|NCT02842528|Behavioral|Diagnostic Interview for Genetic Studies|
16006075|NCT02842528|Behavioral|Family Informant Schedule and Criteria|
16006076|NCT02842528|Behavioral|Temperament and Character Inventory|
16006077|NCT02842528|Behavioral|Barratt Impulsiveness Scale|
16006078|NCT02842528|Behavioral|Wisconsin Card Sorting Test|
16006079|NCT02842528|Genetic|blood sample withdrawn|
16006080|NCT02842515|Other|teeth avulsion|
16006081|NCT02842502|Procedure|Collection of supernumerary biopsies during skin graft pellet procedure|
16006082|NCT02842489|Procedure|left lateral tilt-down position|patients will be positioned on their left side and at an angle of 20 degree
16006083|NCT02842489|Procedure|left lateral horizontal position|patients will be horizontally positioned on their left side
16006084|NCT02842476|Device|Disposable Sensor|Two adhesive based Pulse Oximeter Probes, S0136J-L were connected to the Cadwell Pulse Oximetry and then placed on each subject to evaluate the SpO2 accuracy performance during steady state non-motion conditions.
16006085|NCT02842476|Device|Reusable Sensor|Two soft reusable Pulse Oximeter Probes, Model S0080D-S were connected to the Cadwell Pulse Oximetry and then placed on each subject to evaluate the SpO2 accuracy performance during steady state non-motion conditions.
16006086|NCT02842476|Device|Control Pulse Oximetry|A Clinimark Control Pulse Oximetry system was also placed on the subject to evaluate the stability of the draws.
16006087|NCT02842463|Other|2 times : 6-minute stepper test with a rest of 20min between each test.|
16006088|NCT02842450|Device|Photos + definitions|A broad group of experts (19 proctology and a dermatologist) will be contacted to choose two typical images of LAP (superficial ulceration, deep ulceration ...). 12 photos lesion initially selected by experts.
16006089|NCT02842450|Other|definitions only|
16006090|NCT02842437|Drug|dexmedetomidine|receive a loading infusion of dexmedetomidine (1ug/kg) for 10min follow by a maintenance infusion (0.5ug/kg·h) continued until the end of the surgery
16006091|NCT02842437|Other|normal saline|receive matching placebo (equal volume of normal saline)
16006092|NCT02842424|Drug|Ramipril|Ramipril therapy will start at 2.5mg/day for 1 week. Then 5mg/day for 1 week and will be increased to 10mg/day by the third week. The patients will stay on Ramipril 10mg/day for 22 weeks.
16006093|NCT02842398|Behavioral|Balance Master|
16006094|NCT02842398|Behavioral|Customary Care|
16006095|NCT02842385|Other|Implant|One or two stages of implants within thin and thick gingiva were monitored 1.5 year after placement
16006096|NCT02842359|Drug|Irbesartan/atorvastatin fixed dose combination|Pharmaceutical form:Tablet Route of administration: Oral
16006097|NCT02842359|Drug|Irbesartan SR47436|Pharmaceutical form:Tablet Route of administration: Oral
16006098|NCT02842359|Drug|Atorvastatin|Pharmaceutical form:Tablet Route of administration: Oral
16006099|NCT02842346|Other|ultrasonography|
16006100|NCT02842333|Other|Additional biological samples|Blood samples
16006101|NCT02842320|Other|biological samples|bone marrow and blood
16006102|NCT02842307|Procedure|Manual acupuncture implemented by senior acupuncturists|Manual acupuncture once per day. No limitation on points, manipulations and time per session. Senior acupuncturists have to have more than 15 years of acupuncture clinical practice experience.
16006103|NCT02842307|Procedure|Manual acupuncture implemented by junior acupuncturists|Manual acupuncture once per day. No limitation on points, manipulations and time per session. Junior acupuncturists have to have less than 5 years of acupuncture clinical practice experience.
16006104|NCT02842307|Procedure|Manual acupuncture on P6 point|Manual acupuncture implemented by junior acupuncturists once per day. P6 point, bilaterally, should achieve deqi sensation by even manipulations. Junior acupuncturists have to have less than 5 years of acupuncture clinical practice experience.
16006105|NCT02842294|Drug|Bevacizumab|
16006106|NCT02842281|Other|Fructan|Short-chain oligosaccharide primarily composed of fructose polymers
16006107|NCT02842281|Other|Maltodextrin|Polysaccharide produced from starch
16006108|NCT02842268|Drug|BAY987517|Test product dried for at least 15 minutes.Subjects to ride for 30 minutes on a stationary bicycle.(Formulation Number :Y73-161)
16006109|NCT02842255|Device|Calibrate the oximeter ALTITRAINER200®|During normoxic condition and four situations of hypoxia.
16006110|NCT02842242|Drug|MYK-461|
16006111|NCT02842190|Device|NIPPV|after ekstubation
16006112|NCT02842177|Procedure|Classic group|The speculum was placed into the vagina and the cervix was cleansed with povidone iodine. After placement of single toothed vulsellum on the anterior lip of the cervix, for traction and fixation of the uterus, the uterine sound was inserted for determination of uterine length and uterine position followed by Cu-IUD insertion. The duration of IUD insertion were reported.
16006113|NCT02842177|Procedure|Uterine sounding sparing group|after bimanual examination, the same sonographer (Level II experience) performed transvaginal /US using a SonoAce X6 machine (Medison, Korea) with transvaginal probe (4-8 MHz frequency, using an average 6.5 MHz). Firstly, he evaluated the uterine position. Then, he measured the endometrial and cervical stripe lengths in the sagittal view of the uterus and summed to have the actual length of the uterus; by which the IUD tube was adjusted before insertion.The same speculum and vulsellum were used and the IUD was inserted directly into the uterine cavity.
16006114|NCT02842177|Radiation|Transvaginal ultrasound|
16006115|NCT02842177|Device|Cu-IUD|
16006116|NCT02842164|Other|Tension group|
16006117|NCT02842164|Other|No tension group|
16006118|NCT02842164|Other|Foley catheter Balloon|
16006119|NCT02842151|Procedure|Manifest refraction|Manifest refraction performed by autorefraction (automated) and manual procedures (standard)
16006120|NCT02842151|Device|ACRYSOF® IQ Monofocal IOL Model SN60WF|Monofocal IOL implanted for long-term use over the lifetime of the cataract patient
16006121|NCT02842151|Device|Topcon® KR-1W Wave-Front Analyzer|Wavefront and topography system used to obtain autorefraction data
16006122|NCT02842138|Biological|autologous anti-CD19 CAR T cells|Patients will receive a three-day regimen of chemotherapy consisting of fludarabine and cyclophosphamide aimed to deplete the lymphocytes. Four days after lymphodepletion, patients are intravenously infused autologous anti-CD19 CAR T cells. A prescribed CAR T cell dose will be intravenously infused to patient in a three-day split-dose regimen (day0,30%; day1, 30%; day2, 40%).
16071154|NCT02374567|Drug|Tranylcypromine|
16006123|NCT02842125|Drug|Ad-P53|Adenoviral Investigational Product Ad-P53 to treat metastases using an intra-arterial catheter, with oral metronomic capecitabine
16006124|NCT02842125|Drug|Xeloda|Oral metronomic chemotherapeutic agent
16006125|NCT02842125|Drug|Keytruda|Antineoplastic, Monoclonal Antibody; PD-1/PD-L1 Inhibitors
16006126|NCT02842125|Drug|Opdivo|Antineoplastic, Monoclonal Antibody; PD-1/PD-L1 Inhibitors
16006127|NCT02842112|Other|PBSC mobilization and leukapheresis|"Mobilization and harvest of autologous PBSCs was scheduled during the recovery phase after the consolidation course. Granulocyte colony stimulating factor (G-CSF) (150 µg/m2/day) was given by daily subcutaneous injection from day 20 of the chemotherapy course until completion of the blood stem cell collections. PBSC collections were performed on 1 - 5 consecutive days during the hematopoietic recovery phase, as soon as the leukocyte count exceeded 2x 109/L.
~Collections were performed after induction or after consolidation. In cases in which the minimum number of CD34+ cells was not collected, an additional mobilization was performed in steady state.
~Harvesting was performed using continuous flow blood cell separators. Cells were stored in liquid nitrogen until use, according to standard techniques."
16006128|NCT02842099|Drug|TA or TAC|Taxol, Epirubincin, with or without Cyclophosphamide
16006129|NCT02842099|Drug|X|Capecitabine
16006130|NCT02842086|Drug|F/TAF|200/25 mg tablet administered orally once daily
16006131|NCT02842086|Drug|F/TDF|200/300 mg tablet administered orally once daily
16006132|NCT02842086|Drug|F/TAF Placebo|Tablet administered orally once daily
16006133|NCT02842086|Drug|F/TDF Placebo|Tablet administered orally once daily
16006134|NCT02842073|Drug|Naltrexone|Standard clinical doses of naltrexone 50 mg/d dispensed by the UNC Investigational Drug Services. Naltrexone will be initiated at 25 mg/d from Days 7-9 and then go to 50 mg/d for Days 10-84.
16006135|NCT02842073|Drug|Bupropion|Standard clinical doses of bupropion-XL 300 mg/d (lower seizure risk) dispensed by the UNC Investigational Drug Services. Bupropion XL will be initiated at 150 mg/d on Days 1-4 and increased to 300 mg/d for Days 5-84.
16006136|NCT02842060|Behavioral|myDEx|myDEx will consist of a 6-session online program. Cognizant of challenges maintaining users' attention in a web application and to facilitate delivery through a smartphone, the investigators will design each session to be no more than 20 minutes in length. In the course of these 6 sessions, participants will have a total of 120 minutes of intervention exposure. Across sessions, the investigators will emphasize the importance of sexual decision-making across different partner types, help men consider what type of relationship(s) they want, and align these relationship desires with safer sex practices.
16006137|NCT02842060|Behavioral|NTHP|The investigators will create a 6-session attention-control comparison to match the intervention in time and attention yet have non-tailored and non-interactive content (NTHP). NTHP will include HIV/STI information currently available on sex education websites. The attention-control condition allows the investigators to avoid confounding due to content and ensures that all participants receive some HIV prevention content given their high vulnerability to HIV. Further, this comparison will help critically examine the extent to which tailoring increases the acceptability to the program, above and beyond having a non-tailored, non-interactive intervention.
16006138|NCT02842047|Behavioral|Stop, Breathe & Think™|online daily meditations delivered using smart phone or other computer based application
16006139|NCT02842047|Behavioral|End of Life Planning Videos|Three videos, each 10 minutes in length which will be viewed over the study period. The videos will walk participants though key aspects of end of life planning.
16006140|NCT02842047|Behavioral|Caregiver wellness videos|Three videos, each 10 minutes in length which will be viewed over the study period. The videos will walk participants though general caregiver wellness.
16006141|NCT02842034|Device|Repetitive Transcranial Magnetic Stimulation|Stimulate the dorsomedial prefrontal cortex for 4 weeks.
16006142|NCT02842021|Drug|S2G6T-1|Twice a day topical cream
16006143|NCT02842021|Drug|S2G6T-2|Twice a day topical cream
16006144|NCT02842021|Drug|S2G6T-3|Twice a day topical cream
16006145|NCT02842021|Drug|S2G6T-4|Twice a day topical cream
16006146|NCT02842008|Behavioral|Exercise group|This group will receive a home exercise program of shoulder based on mobility, strength and strengthening exercises, lasting 10 weeks, 3 times per weeks. The target dose use for mobility consisted in 8 repetitions for each 4 movements, for strengthening using resistive bands, 3 sets (including 5 exercises) of 10 repetitions with a 45 second rest between sets and 5 repetitions for each 5 strength with a 30 second rest and general protocol of postural hygiene. The instructional of the program is 30 minutes each day during the time of the study (10 weeks) with a screening about the exercise program and the daily activities performed every 4 weeks. Physiotherapist provided support to subjects through email along 10 weeks.
16006147|NCT02841995|Drug|Belumosudil (KD025)|
16006148|NCT02841982|Procedure|single-injection QLB(quadratus lumborum block)|Inject local anesthetics in between quadratus lumborum and psoas major without continuous local infusion
16006149|NCT02841982|Device|Philip CX50 Ultrasound Scanner|The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scan
16006150|NCT02841982|Device|PAJUNK StimuLong|
16006151|NCT02841982|Drug|single dose ropivacaine|"0.6ml/kg 0.5% ropivacaine with 1:200,000 adrenaline.
~given immediately after the correct position of the tip of the needle has been verified."
16006152|NCT02841982|Drug|Morphine given as IPCA(intravenous patient controlled analgesia)|bolus: 1.5~2mg, lock time: 10min, 1h limitation: 6~8mg
16006153|NCT02841969|Other|Electrolysed water|Irrigation of wound using electrolysed water
16006154|NCT02841969|Other|Prontosan|Irrigation of wound using Prontosan
16006155|NCT02841956|Other|Electronic Screen + Education (Phase 1)|PHASE 1 Electronic Screening Arm + Targeted Education: Referral sources will receive the same standard targeted education as active comparator. In addition, the PQ-B (a 21 item screening questionnaire) will be administered to all patients at their first visit to the referral sites (e.g. intake) via an android tablet provided to the site for ease of administration and scoring. The investigators will provide multiple tablets per site so that the screening is available for more than one individual simultaneously and can be completed in any appropriate location. The investigators will allow paper-and-pencil administration for situations where it is more appropriate (e.g. emergency room).
16006228|NCT02841293|Procedure|Primary perineal wound closure|The intervention consists of stitching the ischioanal and subcutaneous fat using interrupted Vicryl sutures in one or two layers similar to primary perineal closure
16006156|NCT02841956|Other|Targeted Provider Education (Phase 1)|PHASE 1 Targeted Education Intervention: EDAPT standard targeted provider education1 focuses on increasing awareness about the signs of early psychosis & building collaborative relationships with community members so community members see EDAPT as a rapid, effective source of help. It consists of a 2-hour workshop describing: 1) how to identify specific early symptoms & changes associated with the onset of psychotic illness, 2) the benefits of early intervention on treatment outcomes in psychosis, 3) the structure, philosophy & treatment model of the EDAPT Clinic, and 4) procedures for expeditious referral to our program. Case-based vignettes are reviewed to ensure understanding of the key symptoms.
16006157|NCT02841956|Other|Community Mobile Engagement (Phase 2)|PHASE 2 Community-based Mobile Engagement: Clinical assessment appointments will take place at the EDAPT clinic or within the community, wherever the individual would prefer. With patients deemed eligible for EDAPT services, the EDAPT clinician will obtain vitals and contact the EDAPT psychiatrist with a telemedicine-enabled laptop to complete the psychiatric evaluation remotely. The psychiatrist will prescribe medications and order labs, as indicated. The EDAPT clinician will follow up with the individual within 5 days to determine if the prescribed medication regimen has started.
16006158|NCT02841956|Other|Clinic based Engagement (Phase 2)|PHASE 2 Clinic-based Engagement: The clinical assessment appointment will be completed within the EDAPT clinic. If deemed eligible for EDAPT services, the individual will be scheduled for a clinic-based appointment with the EDAPT psychiatrist within 5 days, who will prescribe medications and order labs as indicated. The EDAPT clinician will follow up with the individual within 5 days of the psychiatric evaluation (by phone or in the clinic) to determine if the prescribed medication regimen has started.
16006159|NCT02841930|Other|ActionHealth NYC|care coordination, covered preventive services, and standardized costs for ambulatory care
16006160|NCT02841904|Device|Confocal LASER Endomicroscopy|Patients scheduled for bladder endoscopic surgery under general anesthesia are offered to be included in our study. The suspicious mucosal areas are marked then examined with CLE. Tissue samples are taken based on the usual standard criterias. The samples are evaluated microscopically and compared with the results of the CLE technique. A single surgeon performs all surgeries. Biopsies are anlysed by a pathologist from Herlev and Gentofte Hospital's Pathology Department, which is affiliated CLE- study.
16006161|NCT02841891|Device|Sylys® Surgical Sealant|Standard Stapled Anastomosis Colectomy Procedure with the addition of Sylys® Surgical Sealant
16006162|NCT02841891|Procedure|Stapled Anastomosis Colectomy Procedure|Standard Stapled Anastomosis Colectomy Procedure without the addition of Sylys® Surgical Sealant
16006163|NCT02841878|Genetic|Analysis on colorectal biopsy|
16006164|NCT02841839|Drug|Stannous Fluoride|
16006165|NCT02841826|Other|IUD|
16006166|NCT02841826|Other|Uterine sounding|
16006167|NCT02841826|Radiation|Transvaginal ultrasound|
16006168|NCT02841813|Other|No intervention|No intervention
16006169|NCT02841800|Device|'Intra-luminal radiofrequency ablation (Habib EndoHPB)|endobiliary radiofrequency ablation device
16006170|NCT02841787|Behavioral|iCBT for late life depression|
16006171|NCT02841774|Drug|Pravastatin|40mg daily (Weeks 2 - 14)
16006172|NCT02841774|Drug|Rosuvastatin|20mg daily (Weeks 2 - 14); at Week 6, if AST, AST, and CK <+1.5 x ULN, and LDL-c is >60 and decreased by less than 25% compared with week 2, then dose will be increased to rosuvastatin 40mg daily
16006173|NCT02841761|Drug|Midalozam|Syrup for oral use
16006174|NCT02841761|Drug|ACT-132577|Capsules for oral use
16006175|NCT02841748|Drug|Pembrolizumab|200mg, every three weeks, iv, x 1 year
16006176|NCT02841748|Drug|Placebo|iv, every three weeks, x 1 year
16006177|NCT02841735|Device|Smartphone breathalyzer device/app use|Participants randomized to this condition will be able to blow into the smartphone breathalyzer after consuming each alcoholic drink, which produces an accurate breath alcohol reading on the app. These breath alcohol readings may inform participants' subsequent decisions regarding drinking.
16006178|NCT02841735|Device|BAC estimator app use|Participants randomized to this condition will be able to make an entry into the BAC estimator app after consuming each alcoholic drink, which produces an estimated blood alcohol concentration based on the individual's sex, weight, number of alcoholic drinks and time spent drinking alcohol. These estimated blood alcohol concentrations may inform participants' subsequent decisions regarding drinking.
16006179|NCT02841735|Device|Text messaging procedure|Participants randomized to this condition will be instructed to send a text to a smartphone they will use for the study after each alcoholic drink. A consideration of the number of texts sent may inform participants' subsequent decisions regarding drinking.
16006180|NCT02841722|Procedure|ERIBULIN + G-CSF (Granulocyte-Colony Stimulating Factor)|8 additional blood samples
16006181|NCT02841709|Drug|ACT-541468|Capsules for oral administration containing ACT-541468 at a strength of 5 mg, 10 mg or 25 mg
16006182|NCT02841709|Drug|Placebo|Capsules for oral administration matching the ACT-541468 capsules
16006183|NCT02841696|Device|Cardiac echography|The exam is in the left lateral decubitus position. 4 electrodes are applied to the patient's chest for a synchronization with the Electrocardiogram (ECG). The examination is conducted as standard with acquisition loops of records in parasternal long axis parasternal short axis, apical 4-cavities, 2-cavities and aorta 2 cavities.
16006184|NCT02841683|Behavioral|Tabac Info Service|A smoking cessation E-intervention, Tabac Info Service (TIS), by website and mobile application
16006185|NCT02841670|Device|InFo - Instant Focus (c) lens implantation|
16006186|NCT02841644|Procedure|Operatively treated traumatic arthrotomy|operatively treated traumatic arthrotomy.
16006187|NCT02841644|Other|Non-operatively treated traumatic arthrotomy|non-operatively treated traumatic arthrotomy.
16006188|NCT02841631|Genetic|HPV status and typing of tissue|HPV status and typing of tissue
16006189|NCT02841618|Other|High Linoleic Acid Healthy Cookies|
16006190|NCT02841618|Other|High Oleic Acid Healthy Cookies|
16006191|NCT02841605|Procedure|Rectosigmoidoscopy with colonic biopsies|Rectosigmoidoscopy with colonic biopsies performed for Alzheimer patient and both control groups Parkinson and PSP
16006192|NCT02841605|Procedure|Colonoscopy with colonic biopsies|Colonoscopy with colonic biopsies performed only in patient at risk of colic cancer
16006193|NCT02841592|Other|Flush rate oxygen|Using a standard flowmeter (Precision Medical, 8MFA), the flow of oxygen will be fully opened and oxygen will be administered for three minutes.
16006194|NCT02841592|Other|Flush rate oxygen with assist|Using a standard flowmeter (Precision Medical, 8MFA), the flow of oxygen will be fully opened and oxygen will be administered for three minutes. Positive pressure breaths to match the subject's inspiration will be provided during the three minute period.
16006195|NCT02841579|Drug|Osimertinib|The patients will be treated with 1 tablet of osimertinib (AZD9291) 80 mg per os (p.o.) daily up to 78 weeks from the time of the first administered dose.
16006196|NCT02841566|Other|questionnaire|
16006197|NCT02841540|Drug|H3B-8800|H3B-8800 orally, QD or BID at specified doses.
16006198|NCT02841527|Procedure|Gastric Band|Surgical intervention in which a band is inserted around the top of the stomach to reduce its size.
16006199|NCT02841527|Procedure|Gastric Bypass|Surgical intervention where a small pouch is made in the top of the stomach and a loop of bowel connected to this pouch to bypass the rest of the stomach.
16006200|NCT02841527|Procedure|Sleeve Gastrectomy|Surgical intervention which reduces the size of the stomach by about 75%, creating a narrow tube. It is done by stapling down the stomach and removing the remainder of the stomach.
16006201|NCT02841514|Device|The Y10 Tooth Whitening system including the Y10 toothpaste and the Y10 device|
16006202|NCT02841514|Other|OTC toothpaste and an unoperated Y10 device|
16006203|NCT02841501|Genetic|Analysis of genetic polymorphisms|An analysis of the SNPs (single nucleotide polymorphism) of 25 candidate genes will be performed. This analysis will be completed by a genome wide association study.
16006204|NCT02841488|Procedure|Continuous peripheral sciatic nerve block|Continuous infusion of local anesthetics through perineural sciatic nerve catheter
16006205|NCT02841488|Drug|Fentanyl|Use of patient controlled analgesia device with intravenous fentanyl
16006206|NCT02841488|Drug|Ropivacaine|
16006207|NCT02841488|Device|Perineural catheter|
16006208|NCT02841475|Other|Charlson comorbidity index|Charlson comorbidity index
16006209|NCT02841462|Device|Intra-bursal thermal ablation|A single 3-minute intra-bursal perfusion of a physiological saline solution at increasing temperatures using the Ablaflex device.
16006210|NCT02841449|Behavioral|Hypohydrated|Participants remain hypohydrated after the heat tent procedure
16006211|NCT02841449|Behavioral|Rehydrated|Participants rehydrate after the heat tent procedure
16006212|NCT02841436|Device|Irreversible Electroporation (IRE) System|
16006213|NCT02841423|Procedure|neuropsychological test battery|
16006214|NCT02841410|Other|Magnetic Resonance Imaging|
16006215|NCT02841384|Other|taping patellar McConnell|Taping patellar McConnell: Lateralization correction of the patella with self-adhesive rigid bandage Johnson® positioned lateral border of the patella to the medial condyle of the femur, allowing the lifting of the medial border of the patella and stretching of the knee lateral structures.
16006216|NCT02841384|Other|Placebo taping|Placebo taping through vertical application of patellar rigid taping, with the knee in flexion without medialization of the patella.
16006217|NCT02841371|Radiation|99mTc-DTPA|a 99mTc-DTPA renal dynamic imaging measurement as the reference glomerular filtration rate (rGFR).
16006218|NCT02841358|Biological|Blood sampling|
16006219|NCT02841358|Biological|Biopsy|
16006220|NCT02841345|Other|behavioral and fMRI|"The experience will include 3 sessions. Each session will consist of the presentation of a pseudo-random sequence of 24 black and white images of negative emotional natural scenes, 24 positive emotional situations and 24 neutral emotional situations.
~In the first session, participants will carry out an emotional assessment task: it will show at the end of each test his emotional feeling - pleasant, unpleasant or nothing - using a joystick.
~In a second session, the participant will perform a motor task decision: it will show at the end of each test the tendency to action he would handle the situation actually using 3 buttons également- approach withdrawal or neither one nor the other.
~In the third session, the participant will perform a simple visual perception task. To be comparable to the engine plane with the other sessions, a non-categorical motor task will be requested from participants."
16006221|NCT02841332|Drug|F-MISO|"The fluoro-misonidazole is a positron emission tomography tracer (labeled with Fluorine-18)-specific hypoxia. This compound penetrates into cells where it is reduced by a nitroreductase enzyme. It is rapidly regenerated by reoxidation when the cell is properly oxygenated. This metabolite can accumulate in viable hypoxic cells (necrotic cells that can provide initial reduction reaction of F-MISO).
~Moreover, the fixing of this tracer appears to be independent of blood flow. The advantage of this technique is to provide a direct image of hypoxic cells by directly targeting under stress hypoxic."
16006222|NCT02841332|Other|Cerebral magnetic resonance imagery|"During the pre-therapeutic imagery session :
~Morphological magnetic resonance imagery ( axial T1 sequence axial T1 post contrast , Flair Axial )
~magnetic resonance imagery spectroscopy sequence
~Perfusion magnetic resonance imagery sequence
~Diffusion magnetic resonance imagery sequence"
16006223|NCT02841332|Drug|Bevacizumab|Administration of bevacizumab during 7 cycles of treatment (J1, J15, J30, J45, J60, J120 and J180)
16006224|NCT02841332|Other|Clinical examination|"During the examination, the following parameters will be checked :
~Neurological examination
~Corticotherapy prescribed
~General status of patient (world health organization score)
~Weight and height
~Control of arterial pressure
~Chirurgical and medical history
~Concomitant treatment"
16006225|NCT02841319|Other|Virtual Reality Exercises using Hand Tutor|Virtual reality technology is rapidly becoming a popular application for physical rehabilitation and motor control research. The prototype, which includes a built-in movement sensor, allows the user to do controlled exercises as part of a rehabilitation program. The supervised intervention program consists of a forty-minute exercise session three times a week for 8 weeks. In addition, these patients will receive a home exercise program. The patients in the control group will receive only a home exercise program for 8 weeks. The home exercise program consists of different games and exercises such as range of motion, stretch, and strengthening exercises for hand.
16006226|NCT02841306|Drug|Ursodeoxycholic Acid|
16006227|NCT02841293|Procedure|Biological mesh|The intervention consists of suturing a biological mesh in the pelvic floor defect. The mesh will be sutured at each side of the coccyx or distal sacrum and directly to the residual pelvic floor muscle and fascia by using interrupted or continuous hand-sewn sutures with an appropriate amount of tension. The mesh that will be used is the Cellis prosthesis from Meccellis Biotech, reference C1015E which size is 10x15cm.
16006268|NCT02840929|Procedure|Second-look OGD|Second-look OGD within 16 to 24 hours after primary OGD
16006229|NCT02841280|Drug|Chlorthalidone|This is a forced-titration study and the study drug or placebo will be increased if goal BP is not achieved (dosage of chlorthalidone not to exceed 50 mg)
16006230|NCT02841280|Drug|Placebo|This is a forced-titration study and the study drug or placebo will be increased if goal BP is not achieved (dosage of chlorthalidone not to exceed 50 mg)
16006231|NCT02841267|Drug|PF 06252616|
16006232|NCT02841254|Other|Non interventional study|
16006233|NCT02841241|Drug|Esmolol|Esmolol infusion
16006234|NCT02841228|Radiation|IMRT + SIB + Chemotherapy|For all patients, the dose to the PTV will be kept constant at 60 Gy in 30 fractions at 2.0 Gy per fraction , SIBV will be kept constant at 72 Gy in 30 fractions at 2.4 Gy per fraction. Fractions given once a day, 5 times a week for six weeks. All patients will receive standard concurrent chemotherapy.
16006235|NCT02841215|Drug|Ivermectin 200 µg/kg|Oral ivermectin 200 µg/kg three times (D0, D7 and D14) + topical treatment (permethrin 5% cream) on skin, hair and genital organs (D0 and D7) + emollient cream (Dexeryl® or other) daily on skin (D0 to D28)
16006236|NCT02841215|Drug|Ivermectin 400 µg/kg|Oral ivermectin 400 µg/kg three times (D0, D7 and D14) + topical treatment (permethrin 5% cream) on skin, hair and genital organs (D0 and D7) + emollient cream (Dexeryl® or other)daily on skin (D0 to D28)
16006237|NCT02841202|Drug|oral contraceptive pills|
16006238|NCT02841189|Device|King Vision video Laryngoscope|The King Vision video laryngoscope (Ambu) will be used for tracheal intubation.
16006239|NCT02841176|Other|Thermography|Thermographic imaging of arthritic joints will be performed at baseline and within 5 days after the participant's 2nd and 4th doses of monthly Golimumab
16006240|NCT02841176|Biological|Golimumab|Participants will start monthly Golimumab after their baseline visit
16006241|NCT02841163|Drug|Herbal medicine|Herbal medicine was administered 2-3 times daily in water-based decoction (120ml) and dried powder (2g) form (Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes japonica, Psoralea corylifolia, Saposhnikovia divaricata, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, Glycine max, Atractylodes japonica).
16006242|NCT02841163|Procedure|Acupuncture|Acupuncture treatment was administered 1-2 times daily using mainly proximal acupuncture points and Ah-shi points.
16006243|NCT02841163|Procedure|Pharmacopuncture|Select herbal ingredients (Eucommia ulmoides cortex, Acanthopanax sessiliflorum cortex, Achyranthis bidentata radix, Saposhnikovia divaricata radix, Cibotium barometz rhizoma, Paeonia albiflora radix alba, Ostericum koreanum radix, Angelica pubescens radix, and Scolopendra subspinipes corpus (Paeonia albiflora twice the proportion of that of other ingredients)) were freeze dried into powder form after decoction, then diluted in water-for-injection and adjusted for acidity and pH. Pharmacopuncture was administered once daily at Hyeopcheok (Huatuo Jiaji, EX B2), Ah-shi points and local acupuncture points using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
16006244|NCT02841163|Procedure|Bee venom pharmacopuncture|Bee venom pharmacopuncture was administered only after confirming a negative response to hypersensitivity skin tests. Diluted bee venom (saline:bee venom ratio, 10,000:1) filtered for allergens was injected at 4-5 acupoints proximal to the painful site at the physician's discretion. Each acupuncture point was injected to a total of 0.5-1 cc using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
16006245|NCT02841163|Procedure|Chuna manipulation|Chuna is a Korean version of spinal manipulation that incorporates spinal manipulation techniques for mobilization involving high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement. Chuna manipulation was administered 3-5 times a week to pelvic, lumbar, thoracic, and cervical vertebrae at the physician's discretion.
16006246|NCT02841150|Drug|IMBRUVICA (Treatment A)|IMBRUVICA (reference treatment), 4*140 milligram (mg), capsules.
16006247|NCT02841150|Drug|Ibrutinib (Treatment B)|Ibrutinib (test treatment), 1*560 mg, tablet.
16006248|NCT02841137|Drug|Progesterone|comparison of different dosages of drug towards the active comparator
16006249|NCT02841124|Other|interviews|face-to-face interviews with the referent oncologist (or hematologist) and his patient (conducted by a physician and a psychologist respectively) as well as interviews with other partners involved in the situation (care staff and relatives)
16006250|NCT02841098|Other|Carotid endarterectomy (CEA) combined with optimal medical therapy (OMT)|Carotid endarterectomy (CEA) combined with optimal medical therapy (OMT) (Surgery and Drug)
16006251|NCT02841098|Drug|Optimal medical therapy alone|Optimal medical therapy alone
16006252|NCT02841085|Genetic|Genetic sample|Blood sample or saliva collection
16006253|NCT02841059|Procedure|LSH|laparoscopic subtotal hysterectomy: LSH
16006254|NCT02841059|Procedure|CLSH|laparoscopic cervical ligament sparing hysterectomy: CLSH
16006255|NCT02841059|Procedure|LAVH|laparoscopic assisted vaginal hysterectomy: LAVH
16006256|NCT02841046|Device|cardiac index|group cardiac index（CI） and group Stroke Volume Variation（SVV） are different treatment schemes of goal-directed fluid therapy guided by SVV and CI,group cardiac index with CI as the primary judgment.
16006257|NCT02841046|Device|Stroke Volume Variation|group cardiac index（CI） and group Stroke Volume Variation（SVV） are different treatment schemes of goal-directed fluid therapy guided by SVV and CI,group Stroke Volume Variation with the combination of SVV and CI as the primary judgment.
16006258|NCT02841033|Drug|daratumumab|Daratumumab by IV infusion once weekly for two months, then every 2 weeks for four months, then once each month until progression or inability to tolerate.
16006259|NCT02841020|Procedure|Additional biopsy|• Patients in the experimental group receive the additional biopsy for non-neoplastic disease during the same procedure before the biopsy of the renal mass (with potential for direct benefit to the patient by revealing non-neoplastic renal disease).
16006260|NCT02841007|Device|geko neuromuscular electrostimulation device|
16006261|NCT02840994|Biological|CV301|
16006262|NCT02840994|Biological|Pembrolizumab|
16006263|NCT02840994|Biological|Nivolumab|
16006264|NCT02840955|Device|Staphefekt SA.100|
16006265|NCT02840955|Other|Placebo|
16006266|NCT02840942|Behavioral|Coping Robot|"Socially assistive robot MAKI will interact with children via tablet game designed to teach coping skills."
16006267|NCT02840942|Behavioral|Non-coping Robot|"Socially assistive robot MAKI will interact with children via tablet game designed to be distraction only."
16006270|NCT02840916|Procedure|laser acupuncture|Subjects were treated at acupoints including the Stomach and Hunger points of the ear, ST25, ST28, ST40, SP15, CV9, and SP6 by using laser acupuncture (GaAlAs laser, maximal power, 150 milliwatt; wavelength, 810 nm; area of probe, 0.03 cm2; power density, 5 W/cm2; pulsed wave; 5.625 J/ cm2) over 5 sessions per week, 12 treatment sessions in total.
16006271|NCT02840916|Procedure|sham laser acupuncture|Subjects underwent sham laser acupuncture treatment without any laser output. The acupuncture points, application duration, and total number of treatments were similar to those in verum laser acupuncture group.
16006272|NCT02840903|Drug|Iopromide (Ultravist, BAY86-4877)|8 settings for CT Angiography as described in group description.
16006273|NCT02840890|Procedure|osteopathic technique|Osteopathe will perform continuous pressure on the middle ribs in order to reduce the mechanical stress of the anatomical elements related to liver
16006274|NCT02840890|Procedure|Placebo|patients will have a relaxing osteopathic technique. A non therapeutic abdominal technique
16006275|NCT02840877|Behavioral|DOT Adherence Monitoring|Study participants will meet with a study-employed DOT worker daily during weekdays throughout the course of their TB treatment
16006276|NCT02840864|Device|Sonography assisted breast surgery|
16006277|NCT02840851|Device|MRI|Participants will undergo a MRI scan while two stepwise CO2 elevations are applied to the participant by adding fractional concentration of inspired CO2 (FICO2) at 4% and 6% each time. The end tidal CO2 (PetCO2) will be elevated and maintained constant for a few minutes at each target level. Breath-by-breath changes in respiratory rate and PetCO2 will be measured.
16006278|NCT02840851|Device|TCD|Participants will undergo a TCD scan while two stepwise CO2 elevations are applied to the participant by adding fractional concentration of inspired CO2 (FICO2) at 4% and 6% each time. The end tidal CO2 (PetCO2) will be elevated and maintained constant for a few minutes at each target level. Breath-by-breath changes in respiratory and PetCO2 will be measured.
16006279|NCT02840812|Drug|Nemonoxacin|Nemonoxacin Malate Capsules 500mg single dose oral
16006280|NCT02840799|Drug|Potassium Nitrate (KNO3)|The effect of potassium nitrate (KNO3) supplementation on exercise capacity and peak oxygen consumption in HFpEF will be assessed.
16006281|NCT02840799|Drug|Potassium Chloride (KCl)|Potassium Chloride (KCl) is the matching placebo control drug in this trial.
16006282|NCT02840786|Device|plaque excision system|
16006283|NCT02840786|Device|balloon and Stent|
16006284|NCT02840773|Other|Peri-implanter sulcus fluid sampling|PISF sampling was made twice
16006285|NCT02840773|Other|Probing depth|The change of probing depth between baseline and 12 month after prosthetic loading. Probing depth was measured with a plastic periodontal probe (mm)
16006286|NCT02840773|Other|Crestal bone loss|Crestal bone loss was measured on digital radiographs at baseline and after 1 year of prosthetic loading with a Java program me (Image-J 3.0 NIH, Bethesda, USA)
16006287|NCT02840773|Other|Presence of bleeding on probing|The change bleeding on probing of between baseline and 12 month after prosthetic loading. Presence of bleeding on probing were performed at four sites of implants.
16006288|NCT02840773|Other|Plaque index levels|The change of plaque index level between baseline and 12 month after prosthetic loading. Presence of plaque index was performed at four sites of implants.
16006289|NCT02840760|Device|Repetitive Transcranial Magnetic Stimulation|Stimulate the primary motor cortex for 2 weeks.
16006290|NCT02840734|Other|Kinesio taping|This study was conducted in a randomized crossover double-blind design. Each subject was tested for muscular power, strength, endurance, and fatigue of the lower extremities under three conditions: 1) NT (no taping), 2) PT (placebo taping, 3M tape) and 3) KT (Kinesio taping). For allocation of treatment sequence, the participants drew straws for which treatment first (each treatment indicated different numbers).
16006291|NCT02840721|Drug|PF-06480605|PF-06480605 500 mg IV Q2W x 7 Doses
16006292|NCT02840708|Drug|Sargramostim|
16006293|NCT02840695|Drug|bDMARD treatment|Treatment with bDMARD includes registered ATC-codes: L04AA and L04AB.
16006294|NCT02840669|Procedure|Cardiac magnetic resonance imaging (CMR)|
16006295|NCT02840669|Procedure|Exercise-stress test|
16006296|NCT02840669|Procedure|Echocardiography (ECHO)|
16006297|NCT02840669|Procedure|Cardiac-related blood studies|
16006298|NCT02840656|Other|oropharyngeal swabbing|microbiological sampling will be performed on buccal mucosa with standard swab. only one sample will be done
16006299|NCT02840656|Other|rectal swabbing|same process as oropharyngeal swabbing will be used to collect rectal microbiological sample
16006300|NCT02840643|Behavioral|Bimanual hand therapy|Children will receive 90 hours (6 hrs/day, 5 days/week, 3 weeks) of intensive bimanual hand therapy, which involves actively using both hands in play-based activities, games, arts and crafts, and activities of daily living. The different arms of the study will receive blocks of unimanual (constraint) therapy and bimanual therapy, in different orders.
16006301|NCT02840643|Behavioral|Constraint therapy|Children will receive 90 hours (6 hrs/day, 5 days/week, 3 weeks) of intensive constraint therapy, which involves actively using the impaired hand in play-based activities, games, arts and crafts, and activities of daily living. The different arms of the study will receive blocks of unimanual (constraint) therapy and bimanual therapy, in different orders.
16006302|NCT02840630|Other|Tinned mackerel fish|Diabetic fish intervention group will be given two tinned mackerels per week from week 0 until week 16.
16006303|NCT02840617|Drug|Indocyanine Green (ICG)|
16006304|NCT02840591|Drug|Ramelteon|
16006305|NCT02840591|Drug|Citicoline|
16006306|NCT02840565|Drug|BIA 5-453|Presented as blue hard gelatine capsules (size 2) of 1 mg, 10 mg and 50 mg for oral administration
16006307|NCT02840565|Drug|Placebo|The composition of the placebo is qualitatively the same but without BIA 5-453 pharmaceutical active ingredient.
16006308|NCT02840552|Drug|18F-Fluoromethylcholine (18F-FCH)|FCH PET/CT
16006309|NCT02840539|Drug|Bortezomib, Cytarabine, Dexamethasone, Pegteograstim|"Bortezomib: 1.3mg/m2 per day, SC (mixed with normal saline 1.4ml) on day 1, 4, 8, and 11 of each 28-day cycle
~Cytarabine: 1.5g/m2 per day, IV (in the vein) over 3 hours on day 2 and 3 of each 28-day cycle for subjects aged less than 65 and 1g/m2 with the same route and schedule for those aged 65 or older
~Dexamethasone: 20mg per day, IV (in the vein) or PO on day 1, 4, 8, and 11 of each 28-day cycle
~Pegfilgrastim: 6mg once, SC on day 13 of each 28-day cycle Number of cycles: 6 unless progression or unacceptable toxicity develops within 6 cycles"
16006310|NCT02840526|Procedure|Paravertebral blockade (PVB)|preoperative ThPVB performed unilaterally at Th10 level
16006311|NCT02840526|Drug|Sopodorm|midazolam 0,1 mgkg-1 intravenously (anesthesia induction)
16006312|NCT02840526|Drug|Propofol WZF|propofol 2 mgkg-1intravenously (anesthesia induction)
16006313|NCT02840526|Drug|Nimbex|cis-atracurium 0,15 mgkg-1 intravenously (anesthesia induction)
16006314|NCT02840526|Drug|Fentanyl WZF|fentanyl 1,5 µgkg-1 intravenously (anesthesia induction)
16006315|NCT02840526|Drug|Sevorane|sevoflurane in 1 MAC (Minimal Alveolar Concentration) - anesthesia maintenance
16006316|NCT02840526|Device|Intubation|Intratracheal intubation with a single lumen endotracheal tube
16006317|NCT02840526|Drug|Oxynorm|1 mgml-1 concentration oxycodone solution intravenously
16006318|NCT02840526|Drug|Paracetamol Kabi|1g paracetamol intravenously every 6 hours
16006319|NCT02840526|Drug|Ketonal|100 mg ketoprofen intravenously every 12 hours
16006320|NCT02840526|Drug|Bupivacaine WZF|0,3 ml kg-1 0,5% plain bupivacaine (regional anesthesia - paravertebral blockade)
16006321|NCT02840513|Other|Smartphone app/CO self-monitoring|Smartphone app and carbon monoxide self-monitoring (personal device)
16006322|NCT02840500|Other|No intervention|No intervention
16006323|NCT02840487|Biological|VRC-ZKADNA085-00-VP|VRC-ZKADNA085-00-VP is an investigational ZIKV DNA vaccine that is intended to prevent Zika virus infection.
16006324|NCT02840474|Biological|VRC-HIVMAB080-00-AB|VRC01LS is an investigational human monoclonal antibody targeted to the CD4+ binding site of HIV-1.
16006325|NCT02840474|Biological|VRC-HIVMAB075-00-AB|VRC07-523LS is an investigational human monoclonal antibody targeted to the CD4+ binding site of HIV-1.
16006326|NCT02840461|Drug|Ivermectin Cream, 1%|
16006327|NCT02840461|Drug|Placebo/Vehicle cream|
16006328|NCT02840435|Behavioral|Sit to Quit|Sit to Quit(STQ) is a smoking cessation program adapted from Mindfulness Training for Smokers (MTS) with core content available on the STQ video. STQ contains many elements found in traditional interventions (e.g. instruction on planning and structuring a quit day, garnering support from others, assessment of prior relapse occasions, development of strategies to avoid triggers). In addition, STQ provides instruction in various mindfulness practices and in how to apply mindfulness skills to manage common causes of relapse. Exercises are provided, and it is recommended to learn the skill experientially. STQ requests that participants practice guided meditation each day using an audio recording and employ other mindfulness practices targeted to manage relapse challenges. Participants will also receive the STQ Participant Manual, which provides all the instruction found in the STQ Video, but provides additional discussion of topics for smokers who desire additional material.
16006329|NCT02840435|Behavioral|Quit for Life|"Quit for Life integrates telephone counseling, written materials, NRT, and an online program called Web Coach. Web Coach is an interactive internet-based support system that provides health information on smoking cessation, assistance in the development of quit strategies, and an interactive blog to interact with other smokers. Web Coach is used by approximately 70% of AWI callers. Web Coach is not a complete program, but instead is designed to supplement AWI phone-based therapy. In addition, Quit for Life also provides the Quit Guide, which is a smoking cessation manual with written instructions on the use of medications, planning a quit day, and cessation-related cognitive skills."
16006330|NCT02840422|Device|ARTHRUM H 2%|ARTHRUM H 2%
16006331|NCT02840409|Drug|Vinblastine|
16006332|NCT02840409|Drug|Bevacizumab|
16006333|NCT02840396|Device|rTMS|repetitive TMS (rTMS) can lead to temporary increases or decreases (depending on the protocol used) in excitability of the targeted area. This change in excitability has been shown to last beyond the duration of the stimulation.
16006334|NCT02840396|Device|Sham rTMS|Sham rTMS (or placebo rTMS) refers to a control condition in which no physiological effect on the targeted cortical region occurs.
16006337|NCT02840370|Device|transcranial direct current stimulation|In tDCS, the prefrontal cortex is stimulated during 20minutes through a weak constant electric current (1-2 mA) through two electrodes in a non-invasive and painless manner.
16006338|NCT02840370|Device|Sham tDCS|S-tDCS refers to a control condition in which the subject will receive a brief current in the beginning in order to induce a similar sensation on the scalp as in tDCS, and then the stimulator remains off for the rest of the stimulation time.
16006339|NCT02840357|Other|Purple Wheat Convenience Bars|Whole grain convenience bars manufactured with purple wheat
16006340|NCT02840357|Other|Control Wheat Convenience Bars|Whole grain convenience bars manufactured with ordinary wheat
16006341|NCT02840344|Behavioral|Couples MBSR|Both members of the couple will be asked to participate in the weekly video sessions and activities.
16006342|NCT02840344|Behavioral|Individual MBSR|Only the young breast cancer survivor will participate in the weekly video sessions and activities.
16006343|NCT02840331|Drug|St. John's Wort|Single oral doses (900 milligram) 2-4 hours before laparoscopy
16006344|NCT02840331|Device|Photodynamic diagnostic and therapy|Intraoperative irradiation with light (photodynamic diagnosis (PDD) and therapy (PDT), with the appropriate wavelength (390-440 nanometer) over 15 minutes
16006345|NCT02840318|Other|Compassion Intervention|See arm description
16006346|NCT02840305|Other|Evaluation of visual function|
16006347|NCT02840305|Other|Magnetic Resonance Imaging|
16006348|NCT02840279|Drug|BPN14770|BPN14770 is an investigational new drug being developed for the treatment of Alzheimer's disease and other cognitive disorders. BPN14770 is a small molecule, subtype selective, negative allosteric modulator of phosphodiesterase 4D.
16006349|NCT02840279|Drug|Placebo|
16006350|NCT02840253|Device|NIRS|
16006351|NCT02840240|Drug|Gabapentin enacarbil|600 mg BID 1 day pre-op and 2 hours before surgery, 6 hours after surgery, 600 mg BID 3 days post-operative
16006352|NCT02840240|Drug|Placebo|600 mg BID taken 1 day pre-op and 2 hours before surgery, 6 hours after surgery, 600 mg 3 days post-operative
16006353|NCT02840227|Procedure|General anesthesia with opioid analgesia|General anesthesia with routine drugs and intravenous patient controlled opioid analgesia. General anesthesia may include propofol, isoflurane, sevoflurane, and other drugs.
16006498|NCT02839213|Drug|Hyoscine Butyl bromide|
16006354|NCT02840227|Procedure|Combined general/epidural anesthesia|Combined general/epidural anesthesia and analgesia. General anesthesia may include propofol, isoflurane, sevoflurane, and other drugs. Epidural anesthesia will include bupivacaine and other local anesthetics.
16006355|NCT02840214|Device|transcranial direct current stimulation|Soterix tDCS RCT device given over left DLPFC for 20 minutes at 2mA.
16006356|NCT02840214|Device|sham tDCS|Soterix tDCS RCT device given over left DLPFC with 30 second ramp on and off of current
16006357|NCT02840188|Other|Radius tilt angle|Fracture classification in children. Tilt angle measurement of the distal radius growth plate.
16006358|NCT02840175|Drug|etanercept|will be tapered from every week to every 2 weeks for 12 weeks then to every 3 weeks for 12 weeks
16006359|NCT02840175|Drug|adalimumab|will be tapered from every 2 weeks to every 3 weeks for 12 weeks and to every 4 weeks for 12 weeks
16006360|NCT02840175|Drug|Abatacept|will be tapered from every 4 weeks to every 6 weeks for 24 weeks
16006361|NCT02840175|Drug|Tocilizumab|will be tapered from every 4 weeks to every 6 weeks for 24 weeks
16006362|NCT02840162|Drug|Celecoxib|Selective inhibition of COX-2 without significant cyclooxygenase-1 (COX-1) inhibition
16006363|NCT02840162|Drug|Placebo|
16006364|NCT02840149|Drug|68Ga-DOTATATE PET/CT|68Ga-DOTATATE PET/CT scan
16006365|NCT02840136|Drug|Piperacillin-tazobactam combination product|
16006366|NCT02840136|Drug|Meropenem|
16006367|NCT02840136|Drug|Ceftazidime|
16006368|NCT02840123|Biological|Autologous dendritic cells|
16006369|NCT02840110|Other|ACTR T Cell Product|
16006370|NCT02840097|Drug|Tranexamic Acid|Active drug is provided to participants as described based on the TXA arm they are randomized to.
16006371|NCT02840097|Drug|Placebo|Normal saline is provided to participants if randomized to this treatment arm.
16006372|NCT02840084|Device|Aspen(TM) Ultrasound System|"Two transducers per breast are applied. There will be 10 30 minute sessions, with 2 sessions per week for five weeks. The transducers will be placed on the medial and lateral positions of the affected breast, and then rotated to the superior and inferior aspects, and finally directly over the nipple-areolar complex. Following treatment, the affected breast will be massaged and bandaged per the Aspen Rehabilitation protocol, and the patient will be provided with home exercises as part of the Aspen Rehabilitation Technique.
~The treated breast(s) will be examined both prior to and immediately following each treatment session. To evaluate safety, any adverse events such as swelling, redness, or pain will be assessed. To determine efficacy, any change in the Baker Grade level will be assessed by physical examination. The breasts will be photographed prior to treatment at each visit to assist in evaluation of any visible change in the breasts."
16006373|NCT02840071|Other|Psychological therapy|Acceptance and commitment therapy is a third-wave cognitive behavioural therapy. The aim of ACT intervention is to increase a person's psychological flexibility by enabling them to change their relationship with distressing cognitions (acceptance) and doing things that are personally meaningful to them (commitment). The ACT model does not focus on distress reduction, although this is a secondary consequence of acceptance and commitment. This is targeted through the six core processes: present moment awareness, cognitive defusion, acceptance, self-as-context, values and committed action which means taking effective action, guided by the identified values. The intervention will involve six 1.5 hourly individual sessions.
16006374|NCT02840058|Other|Biological samples|blood and tumor tissue samples
16006375|NCT02840058|Drug|Anti PD1/PDL1 treatment|
16006376|NCT02840045|Device|high-density electroencephalography|Musical stimulation during electroencephalography recording
16006377|NCT02840019|Device|Investigational MRI coil designed for pregnant women|The investigational MRI receiver coil designed specifically for pregnant women will be used during the 60 minute full research MRI scan. An MRI receiver coil is part of the MRI machine that is placed over the body part being imaged during every MRI scan. A coil is required to obtain MR images, yet there isn't one designed for pregnant women. This investigational MRI receiver coil for pregnant women will be tested to see if it helps improve image quality and take images faster.
16006378|NCT02840019|Procedure|MRI Scan|All participants will participate in an MRI scan. The add-on MRI scan will be 15 minutes. The full MRI scan will be 60 minutes.
16006379|NCT02840006|Procedure|General anesthesia only|Induction drugs: Citrate of fentanyl, atracurium, etomidate
16006380|NCT02840006|Procedure|General anesthesia and Spinal anesthesia|Induction drugs: Citrate of fentanyl, atracurium, etomidate Spinal anesthesia: Bupivacaine hyperbaric, Morphine
16006381|NCT02839993|Device|tDCS|
16006382|NCT02839993|Behavioral|training|
16006383|NCT02839967|Other|Photobiomodulation|Intraoral photobiomodulation is applied in the temporal, medial and lateral pterygoid, bilateral, totaling 4 points of application of phototherapy. The researcher who will perform the treatments will receive the equipment with the stylus activates and pre-programmed dose, an eye protection (glasses, opaque) will be used by the participants, to protect the eyes, because the same does not cause any sensation to volunteer. The technique is used, contact an area. The individual is positioned supine on a stretcher, with the legs supported on a foam roller 20 cm in diameter, the head supported on a pillow, to accommodate her comfortably in a resting posture, prompted the opening of the mouth and placing the tip of photobiomodulation in sections as described below, with 2 minutes interval between one application and another for rest with the mouth closed.
16006384|NCT02839967|Other|Photobiomodulation placebo|The volunteers will be subjected to the same Group intervention, Photobiomodulation and the researcher will receive the equipment unaware if the pen that will apply the phototherapy is active or placebo, only the research coordinator will have this knowledge, and for this group the researcher will receive placebo pen. Fits the caveat that, when the voluntary participation, will be held with the active pen treatment.
16006385|NCT02839954|Biological|anti-MUC1 CAR-pNK cells|
16006386|NCT02839941|Drug|Iguratimod|Subjects will receive iguratimod orally, twice a day, for consecutive 52 weeks
16006387|NCT02839941|Drug|Mycophenolate mofetil|All subjects will receive mycophenolate mofetil for consecutive 52 weeks
16006388|NCT02839941|Drug|Tacrolimus|All subjects will receive tacrolimus for consecutive 52 weeks
16006389|NCT02839941|Drug|Glucocorticoids|All subjects will receive glucocorticoids for consecutive 52 weeks
16006390|NCT02839928|Drug|Intranasal ketamine|The experimental arm consists of an single intranasal administration of Ketamine (Ketalar).
16006499|NCT02839213|Drug|Saline|
16006391|NCT02839928|Device|Intranasal atomizer|Ketamine will be applied to each nare via intranasal atomizer
16006392|NCT02839928|Drug|EMLA|
16006393|NCT02839915|Drug|Folinic Acid|Liquid levo-leucovorin via oral route. L-leucovorin is the active isomer.
16006394|NCT02839915|Other|Placebo|Inactive placebo comparator
16006395|NCT02839902|Drug|TAK-085|Omega-3-acid ethyl esters (TAK-085) capsule
16006396|NCT02839902|Other|Not treated with omega-3-acid ethyl esters|Not treated with omega-3-acid ethyl esters
16006397|NCT02839889|Drug|Naloxegol|Naloxegol 25mg tablets for two weeks, followed by a two week open-label period
16006398|NCT02839889|Drug|Placebo|Placebo once daily for two weeks, followed by two week open-label period
16006399|NCT02839876|Drug|Intravenous acetaminophen|Subject receives 1 g acetaminophen by the intravenous route every 6 hours for 4 doses beginning in the preoperative holding area.
16006400|NCT02839876|Drug|Oral acetaminophen|Subject receives 1 g acetaminophen by the oral route every 6 hours for 4 doses beginning in the preoperative holding area.
16006401|NCT02839850|Device|Cementless Total Knee Arthroplasty|Patients will undergo a primary total knee replacement using one of the two configurations of the ATTUNE Cementless knee (CR RP or PS RP)
16006402|NCT02839837|Behavioral|Aerobic Exercise|Aerobic exercise will be performed on a stationary cycle ergometer for 15 minutes at an intensity of 35% heart rate reserve or 70% heart rate reserve. During the control condition the participant will remain seated on the stationary cycle for 15 minutes and will not perform exercise.
16006403|NCT02839837|Device|Paired Associative Stimulation|After aerobic exercise participants will receive a paired associative stimulation (PAS) paradigm. PAS consists of paired brain and peripheral nerve stimuli. Participants will receive 200 paired stimuli. Peripheral nerve stimulation will be delivered to the median nerve at the level of the wrist via electrical stimulation at 300% perceptual threshold. Brain stimulation will be delivered via transcranial magnetic stimulation (TMS) over the hand knob of the motor cortex at an intensity that elicits a 1mV response in the contralateral abductor pollicis brevis muscle. During each paired stimulation, peripheral nerve stimulation will precede the TMS stimulation by 25ms.
16006404|NCT02839824|Procedure|Bowel preparation|Bowel preparation for bowel cleansing in a real clinical practice
16006405|NCT02839811|Procedure|Immediate hypersensitivity to BLC|immediate hypersensitivity to BLC by In vitro diagnosis
16006406|NCT02839798|Device|NEST (NeoSync EEG Synchronized TMS)|The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Bipolar Depression.
16006407|NCT02839785|Drug|Ibuprofen|the child will take orally 30 minutes before each session of physiotherapy 10mg/kg of Ibuprofen (not to exceed 400 mg) in liquid form or placebo.
16006408|NCT02839785|Drug|Placebo|the child will take orally 30 minutes before each session of physiotherapy 10mg/kg of Ibuprofen (not to exceed 400 mg) in liquid form or placebo.
16006409|NCT02839772|Other|Current skin care regimen plus 2% glycerine added to soaking water|
16006410|NCT02839772|Other|Current skin care regimen|
16006411|NCT02839759|Other|TELLYHealth|Educational videos and questions.
16006412|NCT02839720|Other|Laboratory Biomarker Analysis|Correlative studies
16006413|NCT02839720|Drug|Selumetinib Sulfate|Given PO
16006418|NCT02839694|Drug|decitabine (DAC)|Administered IV at increasing frequency or dose from 3-5 times per week for 8-12 weeks
16006419|NCT02839694|Drug|Tetrahydrouridine (THU)|Administered IV at increasing frequency or dose from 3-5 times per week for 8-12 weeks
16006420|NCT02839694|Drug|Celecoxib|400 mg orally twice a day every day for while on DAC-THU therapy
16006421|NCT02839681|Drug|Anetumab Ravtansine|Administered intravenously (IV) every 3 weeks
16006422|NCT02839681|Device|Blood test|Research blood test for eligibility
16006423|NCT02839668|Drug|Lidocaine|Continuous infusion of lidocaine
16006424|NCT02839668|Drug|Sevoflurane|maintenance of hypnosis during anaesthesia with sevoflurane
16006425|NCT02839668|Drug|TIVA-TCI|maintenance of hypnosis during anaesthesia with sevoflurane
16006426|NCT02839668|Drug|Acetaminophen|administration of 1 g acetaminophen for postoperative analgesia
16006427|NCT02839668|Drug|Tramadol|administration of tramadol for postoperative analgesia
16006428|NCT02839668|Drug|Neostigmine|A 0.05 mg/kg dose of neostigmine will be administered to antagonize the neuromuscular block at the end of surgery.
16006429|NCT02839668|Drug|Atropine|A 0.2 mg/kg dose of atropine will be administered at the end of surgery to attenuate the parasymatomimetic effects of neostigmine
16006430|NCT02839668|Device|BIS|For the groups receveing TIVA-TCI anesthesia the bispectral index will be monitored
16006431|NCT02839655|Device|Da Vinci Xi|
16006432|NCT02839642|Drug|Rivastigmine|
16006433|NCT02839642|Drug|Placebo|
16006434|NCT02839629|Other|Non-Interventional|
16006435|NCT02839616|Procedure|orthotopic liver transplantation|
16006436|NCT02839590|Device|HiFU|Ciliary Ablation Treatment ( HiFu ultrasound treatment)
16006437|NCT02839590|Device|Baerveldt implant|External (sub-conjunctival) Drainage Surgery (Baerveldt implant)
16006438|NCT02839590|Device|Ahmed implant|External (sub-conjunctival) Drainage Surgery (Ahmed Implant)
16006439|NCT02839590|Device|STARflo|Suprachoroidal Shunt Surgery (STARflo)
16006440|NCT02839590|Device|Hydrus Microstent implant|Trans-trabecular meshwork implants (Hydrus Microstent implant).
16006441|NCT02839590|Device|iStent implant|Trans-trabecular meshwork implants (iStent implant).
16006442|NCT02839590|Device|Kahook Dual Blade|It removes part of the trabecular meshwork
16006443|NCT02839577|Drug|High Volume injection without corticosteroid|"Injection with 10 mls 0.5% bupivacaine hydrochloride and
~• 40 ml saline around the tendon."
16006444|NCT02839577|Drug|High Volume injection with corticosteroid|Injection with 10 mls 0.5% bupivacaine hydrochloride, 20 mg Depomedrol and 40 ml saline around the tendon.
16006494|NCT02839239|Dietary Supplement|Drops with lactobacilli and vitamin D3|Oil suspension with lactobacilli and vitamin D3
16006445|NCT02839564|Procedure|Laparoscopic adhesiolysis|After diagnostic laparoscopy to confirm adhesions and exclude other pathology laparoscopic adhesiolysis was performed
16006446|NCT02839564|Procedure|Diagnostic laparoscopy|After diagnostic laparoscopy to confirm adhesions and exclude other pathology treatment was stopped.
16006447|NCT02839551|Procedure|simplified drug provocation test|Assessment of the Hypersensitivity to betalactams by simplified drug provocation test
16006448|NCT02839538|Procedure|Local Infiltration|Injection at perianal region with ropivacaine 0.75%(20ml)
16006449|NCT02839538|Procedure|Subarachnoidal block|Injection at subarachnoidal space with bupivacaine 0.5% ( 2ml)
16006450|NCT02839525|Dietary Supplement|Omega 3|3000mg of n-3 oil (2000mg EPA e 1000mg DHA)
16006451|NCT02839525|Dietary Supplement|Isolate whey protein|23g of protein of whey protein
16006452|NCT02839525|Dietary Supplement|Omega 3 and Isolate whey protein|3000mg of n-3 oil (2000mg EPA e 1000mg DHA) and 23g of protein of whey protein
16006453|NCT02839525|Other|Eccentric exercise|100 maximal eccentric contractions of knee extensors, divided into 10 sets of 10 repetitions at intervals of 60 seconds between the series
16006454|NCT02839512|Device|Jejunal to Ileal Diversion|The Jejunal to Ileal Diversion procedure will be performed using colonoscopes to place magnets to create a side to side compression anastomosis. The colonoscope delivered magnet creates the proximal end of the anastomosis approximately 100 cm distal from the ligament of Treitz. The colonoscope delivered magnets creates the distal end of the anastomosis approximately 100 cm proximal from the ileocecal junction.
16006455|NCT02839499|Device|RU sleeping®|Each patient included in the study has a test by RU-sleeping. The diagnosis of obstructive sleep apnea syndrome will be asked for an index of respiratory events estimated as greater than or equal to 10.
16006456|NCT02839499|Other|autonomy scale (ADL and AGGIR)|autonomy data
16006457|NCT02839499|Other|various activity scale (IADL)|activity of life data
16006458|NCT02839486|Other|vancomycin pharmacokinetics|vancomycin serial plasmatic and ultrafiltrate samples in order to assess plasmatic and ultrafiltrate drug concentrations
16006459|NCT02839486|Other|cefoxitin pharmacokinetics|cefoxitin serial plasmatic and ultrafiltrate samples in order to assess plasmatic and ultrafiltrate drug concentrations
16006460|NCT02839473|Device|Castalie water spray|
16006461|NCT02839473|Device|Hydrogel Hydrosorb®|
16006462|NCT02839460|Procedure|Outpatient Muscle Biopsy|Outpatient Muscle Biopsy involving skeletal muscle sample collected from the vastus lateralis muscle
16006463|NCT02839447|Other|no intervention|
16006464|NCT02839434|Procedure|Blood sample|This blood sample does not require specific puncture because it is made on the occasion of a sample justified by the patient monitoring.
16006465|NCT02839421|Drug|Scaling and Root Planing combined with moxifloxacin|Scaling and Root Planing combined with systemically administered moxifloxacin (MOX) 400 mg, once daily for 7 days
16006466|NCT02839408|Dietary Supplement|Lactobacillus rhamnosus SP1|Sachet containing Lactobacillus rhamnosus SP1
16006467|NCT02839408|Drug|Azithromycin|Tablet containing 500mg Azithromicyn
16006468|NCT02839408|Other|Talc powder|Sachet containing talc powder and tablet containing talc powder
16006469|NCT02839408|Procedure|Periodontal treatment Scaling and root planning|
16006470|NCT02839395|Other|No intervention- base line|the subject will sited in a dim light room. No screen light illumination.
16006471|NCT02839395|Other|Acute|The subject will be sited in front of computer screen light illumination for 2 hours.
16006472|NCT02839395|Other|Chronic|The subject will be sited in front of computer screen light illumination for 2 hours for 5 consecutive days.
16006473|NCT02839382|Other|Coaching|An external facilitator or coach is assigned 15-20 primary care clinics and will make face-to-face site visits and monthly phone calls for 15 months to support building QI capacity in each assigned practcie
16006474|NCT02839382|Other|Educational Outreach|Practices randomized to this arm of the study will receive an educational outreach phone call by an academic expert on implementation strategies for use of a cardiovascular risk calculator within their daily work flow and clinic setting
16006475|NCT02839382|Other|Site Visits|"Practices randomized to this arm of the study will be given an opportunity to make a site visit to an exemplar practice to learn about innovative approaches to conducting quality improvement activities."
16006476|NCT02839369|Other|walking under varies conditions|The children were asked to walk an electronic mat, three cycles for each one of the different trials as comfortable regular speed, walking as fast and as slow as possible, walking on straight line etc
16006477|NCT02839369|Other|walking under varies conditions|walking on electronic walkway under different conditions
16006478|NCT02839356|Drug|epinephrine|20-mL irrigation with epinephrine diluted to 0.02% in saline over the entire papilla
16006479|NCT02839356|Drug|normal saline|20-mL irrigation with physiological saline over the entire papilla
16006484|NCT02839330|Biological|aH5N1c|Intramuscular (IM) administration, containing 7.5 mcg H5N1 hemagglutinin antigen (HA) + 0.25 mL MF59 (approximately 0.5 mL total volume).
16006485|NCT02839330|Biological|Placebo|Placebo: Saline injection
16006486|NCT02839317|Biological|Biological|comparison of microbiota, genetic profile between pediatric- and elderly-onset CD
16006487|NCT02839304|Device|Cryoablation System|Pulmonary Vein Isolation, Posterior Wall Isolation. May Include Mitral Line ablation, AF Driver ablation, and Cavo-tricuspid Isthmus ablation as indicated
16006488|NCT02839291|Other|quality of life questionaries|
16006489|NCT02839291|Drug|intravenous or oral bone antiresorptive treatments|
16006490|NCT02839278|Biological|Blood sample|
16006491|NCT02839265|Drug|FLT3 Ligand Therapy (CDX-301)|See Arm 1 descriptions
16006492|NCT02839265|Radiation|Stereotactic Body Radiotherapy (SBRT)|See Arm 1 descriptions
16006493|NCT02839252|Behavioral|Iggy and the Inhalers Asthma Education for Kids|It is a comic book, trading cards, and stickers that teach kids about asthma. There is also a 12-minute cartoon video which teaches kids about asthma.
16006495|NCT02839239|Dietary Supplement|Drops with vitamin D3|Oil suspension with vitamin D3
16006500|NCT02839200|Drug|ACT-541468 5 mg|Capsule for oral administration containing ACT-541468 at a strength of 5 mg
16006501|NCT02839200|Drug|ACT-541468 10 mg|Capsule for oral administration containing ACT-541468 at a strength of 10 mg
16006502|NCT02839200|Drug|ACT-541468 25 mg|Capsule for oral administration containing ACT-541468 at a strength of 25 mg
16006503|NCT02839200|Drug|Zolpidem|Over-encapsulated zolpidem tablet at a strength of 10 mg
16006504|NCT02839200|Drug|Placebo 1|Placebo capsules matching ACT-541468 capsules
16006505|NCT02839200|Drug|Placebo 2|Placebo capsules matching over-encapsulated zolpidem
16006506|NCT02839187|Radiation|Neuroimaging|AV45-positron emission tomography
16006507|NCT02839161|Biological|Na-GST-1/Alhydrogel|
16006508|NCT02839161|Biological|Na-APR-1 (M74)/Alhydrogel|
16006509|NCT02839161|Biological|Hepatitis B Vaccine|
16006510|NCT02839148|Dietary Supplement|Food supplementation|"Arm 1 will be given food supplementation (FS), psychosocial stimulation (PS) and routine clinical care will be given and arm will be provided only with routine clinical care.
~The control children will receive routine clinical care but no FS or PS."
16006511|NCT02839135|Drug|Reformulated scopolamine patch|Reformulated scopolamine patch of 1.5 mg (+/- 0.3 mg) /system of 2.5 cm2 surface area with deliver approximately 1.0 mg over 72 hours
16006512|NCT02839135|Drug|Marketed scopolamine patch|Marketed scopolamine patch of 1.5 mg (+/- 0.3 mg) /system of 2.5 cm2 surface area with delivery of approximately 1.0 mg over 72 hours.
16006513|NCT02839122|Drug|Tadalafil|
16006514|NCT02839122|Drug|Dutasteride|
16006515|NCT02839096|Drug|Placebo|Cellulose placebo that will be used in place of a second dose of ferrous sulfate in the subjects randomized to once daily dosing of ferrous sulfate
16006516|NCT02839096|Drug|Ferrous Sulfate|Subjects will receive once or twice daily dosing of ferrous sulfate. This will be provided by our hospital pharmacy and be identical in appearance to the placebo.
16006517|NCT02839083|Other|Thoracic Paravertebral group|Thoracic paravertebral block is performed using bupivacaine 0.25% in a total volume of 30 ml
16006518|NCT02839083|Other|Pecs II group|Ultrasound guided ipsilateral Pecs II block is performed using bupivacaine 0.25% in a total volume of 30 ml
16006519|NCT02839070|Other|Sleep/Wake Schedule|Timing of sleep and wake
16006520|NCT02839057|Procedure|Non-surgical treatment|Cervical collar immobilisation for 12 weeks.
16006521|NCT02839057|Procedure|Surgical treatment|Stabilisation of C2-fracture by posterior fusion C1-C2, posterior fusion C2-C3, anterior fusion C2-C3 (no postoperative collar) or anterior screw osteosynthesis C2 (postoperative collar for 6 weeks).
16006522|NCT02839044|Dietary Supplement|Menaquinone-7|
16006523|NCT02839044|Dietary Supplement|Placebo|
16006524|NCT02839031|Behavioral|"CBT (Cognitive-Behavioral Therapy)"|
16006525|NCT02839031|Behavioral|Control (telephonic support without CBT content)|
16006526|NCT02839005|Other|Continuous suture with polyglecaprone 25|At the end of surgical procedemento of cesarean delivery , for skin closure continuous suture was performed with polyglecaprone 25
16006527|NCT02839005|Other|Continuous suture with polyamide (nylon)|At the end of surgical procedemento of cesarean delivery , for skin closure continuous suture was performed with polyamide (nylon)
16006528|NCT02838992|Drug|Rabbit ATG, (Genzyme)|ATG is an infusion of rabbit-derived antibodies against human T cells, which is used in the prevention and treatment of acute rejection in organ transplantation and therapy of aplastic anemia
16006529|NCT02838992|Drug|Cy|Cyclophosphamide is a medication mainly used in chemotherapy. It is an alkylating agent of the nitrogen mustard type
16006530|NCT02838992|Drug|CsA|CsA is an immunosuppressant drug widely used in organ transplantation to prevent rejection. It reduces the activity of the immune system by interfering with the activity and growth of T cells
16006531|NCT02838992|Biological|Cord blood|Cord blood is blood that remains in the placenta and in the attached umbilical cord after childbirth. Cord blood is collected because it contains stem cells, which can be used to treat hematopoietic and genetic disorders
16006532|NCT02838979|Dietary Supplement|L-glutamine|Oral Glutamine for 2 weeks at dose of 0.4mg/kg/day in three divided daily doses
16006533|NCT02838979|Dietary Supplement|Maltodextrin|Oral maltodextrin as described for the active agent: 2 weeks at dose of 0.4mg/kg/day in three divided daily doses.
16006534|NCT02838966|Dietary Supplement|Nestle IMPACT Advanced Recovery|
16006535|NCT02838966|Dietary Supplement|Nestle Boost High Protein Drink|
16006536|NCT02838953|Behavioral|Pulmonary Rehabilitation|Comprehensive intervention based on a thorough patient assessment followed by patient- tailored therapies that include, but are not limited to, exercise training, education, and behavior change, designed to improve the physical and psychological condition of people with chronic respiratory disease and to promote the long-term adherence to health-enhancing behaviors.
16006537|NCT02838940|Procedure|Blood samples.|"At the beginning of the first incision in the skin, first blood sample will be taken for levels of antibiotics in serum test.
~Second blood sample for drug levels in serum test, will be taken while closing the surgical incision in the skin at the end of the operation."
16006538|NCT02838940|Drug|Cefazolin|According to the ward protocol prior to the anesthesia by an anesthesiologist, the women will receive one dose of 1 g Cefazolin the usual loading dose. Women with a BMI over 30 will receive Cefazolin of about 2 grams.
16006539|NCT02838927|Other|No intervention|No intervention
16006540|NCT02838914|Procedure|radiofrequency ablation (RFCA)|Patients undergo radiofrequency ablation (RFCA)
16006541|NCT02838901|Drug|Beet it Beetroot juice|Concentrated organic beetroot (98%) and lemon juice (2%); 70ml bottle
16006542|NCT02838901|Drug|Beet It Placebo Beetroot juice|Concentrated organic beetroot (98%) and lemon juice (2%) with nitrate extracted; 70ml bottle. Beet It Placebo Beetroot juice.
16006543|NCT02838888|Device|Automatic polyp detection software|A computer program for the detection of colonic polyps will be used during colonoscopy
16006544|NCT02838875|Procedure|Blood samples|After birth - taking blood sample from the umbilical cord (arterial and venous) + blood sample from the patient.
16006545|NCT02838849|Dietary Supplement|Fiber|Fiber composed of wheat bran, pectin and green banana flour (total daily amount of 13 g for women and 20 g for men), keeping the usual liquid intake
16006689|NCT02837770|Drug|Oral Diclofenac|One Diclofenac Sodium sustained-release 75mg tablet administered per os 4 hours prior to the IVI.
16006546|NCT02838849|Dietary Supplement|Fiber and Water|Fiber composed of wheat bran, pectin and green banana flour (total daily amount of 13 g for women and 20 g for men) plus 2 liter of water/day
16006548|NCT02838823|Biological|humanized anti-PD-1 monoclonal antibody toripalimab|humanized anti-PD-1 monoclonal antibody (JS001) is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically.
16006549|NCT02838810|Drug|peginterferon alfa|peginterferon alfa-2b or peginterferon alfa-2a
16006550|NCT02838810|Drug|Nucleoside analogues|Nucleoside analogues
16006551|NCT02838797|Drug|RQ-00000010|orally administered serotonin 4 receptor partial agonist
16006552|NCT02838797|Drug|Placebo|oral acetate buffer
16006553|NCT02838784|Other|Artacent Human Amniotic Membrane|Double layer dehydrated amnion product
16006554|NCT02838784|Procedure|Standard of Care|Off loading with a cast walker, non-adherent dressings, debridement and moisture retentive dressings
16006555|NCT02838771|Other|Water drinking test|Patient takes a sip of water about 60-70 ml. We assess: coughing, choking, voice changes.
16006556|NCT02838771|Other|Dysphagia screening questionnaire|Lithuanian version of the questionnaire consists of 16 questions. Interpretation of dysphagia screening questionnaire: advanced symptom - 2 points, moderate intensity symptom - 1 point, no symptom - 0 point. At least one advanced symptom means - dysphagia. Higher score represents stronger dysphagia intensity. The maximum score is 32 points.
16006557|NCT02838758|Device|Cryoablation|A minimally invasive cryoablation device. It delivers focused nitrous oxide to the target tissue via a 22-gauge needle to create an approximately 9.4mm by 5.4mm spherical freezing zone of temperature between -20 to -100° C.
16006558|NCT02838758|Drug|Lidocaine|Roughly 3cc of lidocaine will be injected near the intermetatarsal neuroma under ultrasound visualization.
16006559|NCT02838758|Drug|Saline|Roughly 3cc of saline will be injected near the intermetatarsal neuroma under ultrasound visualization.
16006560|NCT02838745|Drug|Pemetrexed|
16006561|NCT02838745|Drug|Cisplatin|
16006562|NCT02838732|Dietary Supplement|L-carnitine|
16006563|NCT02838719|Drug|Perineural Dexamethasone acetate|
16006564|NCT02838719|Drug|Intravenous dexamethasone acetate|
16006565|NCT02838706|Procedure|Surgery for hip fracture|
16006566|NCT02838693|Procedure|Not applicable. This is an observational study.|Not applicable. This is an observational study.
16006567|NCT02838680|Device|HLT Transcatheter Aortic Valve System|Transcatheter aortic valve replacement with HLT Transcatheter Aortic Valve System
16006568|NCT02838667|Procedure|Standard of Care plus Nephrology Care|
16006569|NCT02838654|Procedure|cervical epidural injection|sensitivity, specificity, positive predictive value, negative predictive value
16006570|NCT02838641|Device|GeneXpert|Real time integrated and automated nucleic acid amplification test for detection of TB
16006571|NCT02838628|Drug|50 mg of KX2-391 Ointment 1%|Dose: 50 mg; Route of administration: Topical
16006572|NCT02838628|Drug|50 mg of KX2-391 Ointment 1%|Dose: 50 mg; Route of administration: Topical
16006573|NCT02838615|Procedure|epidural steroid (dexamethasone) injection|spinal injections performed in epidural space to relieve chronic low back pain or leg pain
16006574|NCT02838602|Radiation|Carbon ions therapy|External radiotherapy by accelerated carbon nucleus in a specialized hadrontherapy center
16006575|NCT02838602|Radiation|Advanced external radiotherapy by Xrays or protons|Radiotherapy by any appropriate advance procedure of photontherapy (IMRT, Volumetric Modulated Arc Therapy (VMAT), Tomo, etc.) or when possible by protontherapy or even a combination of both types of radiotherapy
16006576|NCT02838589|Drug|Byetta|Single dose of subcutaneous injection of 5 μg exenatide (Byetta).
16006577|NCT02838589|Drug|Isotonic saline|Single dose of subcutaneous injection of 20 μL isotonic saline (placebo).
16006578|NCT02838576|Drug|Conjugated Equine Estrogen|Use of conjugated equine estrogen for 12 weeks. Adherence will be monitored during periodical hospital visits in order to receive pills.
16006579|NCT02838576|Drug|Placebo|Use of placebo for 12 weeks. Adherence will be monitored during periodical hospital visits in order to receive pills.
16006580|NCT02838563|Other|SIWA|To investigate the scale reliability over time, SIWA are assessed twice, ten minutes apart. To investigate the validity of the tool, SIWA is correlated with another quality of life questionnaire (QoL-AD), a quality of health scale including an analog portion (EQ 5D), and a behavioral disorder scale (Neuropsychiatric Inventory, NPI).
16006581|NCT02838550|Behavioral|Motivational Online Intervention|"The self-administered Motivational Online Intervention developed by the authors was based on the Transtheoretical Model of Change. It attempts to facilitate the decisional balance, the increase of the self-efficacy, and the use of experiential and behavioral processes of change (e.g., consciousness raising, counterconditioning, reinforcement management, stimulus control). The main objective is to deliver information to increase the motivation to practice physical activity and to set individualized goals. It has a total length of 45 minutes, and it is delivered in a web platform at the beginning of the intervention."
16006582|NCT02838550|Behavioral|Pedometer|Wearing a pedometer of new generation that provides motivational messages from time to time to motivate the user to increase the physical activity, as well as information in the screen regarding all-day activity: steps taken, calories burned, distance travelled, floors climbed and active minutes.
16006583|NCT02838537|Drug|Exposure to Triptan|
16006584|NCT02838537|Drug|Exposure to Ergot|
16006585|NCT02838511|Other|Modified Frailty Index (MFI)|non-cardiac surgical patients will have frailty evaluated
16006586|NCT02838511|Other|Hopkins Frailty Score (HFS)|non-cardiac surgical patients will have frailty evaluated
16006587|NCT02838498|Device|ERCP Mechanical Simulator (EMS)|Hands on EMS training
16006588|NCT02838485|Other|Mirror|The healthy hand will be mirrored and the amputated hand unseen by the subject while performing hand movements.
16006589|NCT02838485|Other|Imagery|The subject will be asked to imagine performing hand movements.
16006590|NCT02838472|Drug|Ascorbic Acid|Ascorbic acid administration at a doses of 75-80% of the upper limit of allowance according to IOM
16006690|NCT02837770|Drug|Diclofenac Eye Drops|One drop of Diclofenac 0.1% will be instilled 45' prior to the IVI.
16006591|NCT02838446|Procedure|Cognitive Therapy|"Graded Motor Imagery has three stages:
~Lateralisation (2 or 3 weeks) Motor Imagery (2 or 3 weeks) Mirror Therapy (2 or 3 weeks)"
16006592|NCT02838433|Other|biological samples|blood and tissue samples
16006593|NCT02838420|Drug|Alectinib|Alectinib capsules will be administered orally at a dose of 600 mg BID until disease progression, unacceptable toxicity withdrawal of consent, or death.
16006594|NCT02838420|Drug|Crizotinib|Crizotinib capsules will be administered orally at a dose of 250 mg BID until disease progression, unacceptable toxicity withdrawal of consent, or death.
16006595|NCT02838407|Other|BAL fluid sampling|Following routine BAL procedures at the hospital, collection of BAL fluid samples: at least 2 mL, at Day 0.
16006596|NCT02838407|Other|Nasopharyngeal swab sampling|1 swab, Day 0
16006597|NCT02838394|Procedure|Dry needling|Acupuncture filiform needles are inserted into myofascial trigger points
16006598|NCT02838394|Other|Sham dry needling|Blunted needles will be pressed against the skin, but no actual penetration will occur
16006599|NCT02838381|Other|Additional biological samples|blood and tissue samples
16006600|NCT02838355|Device|Respiratory Depression Monitoring with End Tidal Carbon Dioxide Nasal Cannula (ETCO2- NC)|The ETCO2-NC is a non-invasive device that monitors the amount of carbon dioxide that is exhaled with every breath.
16006601|NCT02838355|Other|Standard Non-invasive Respiratory Depression Monitoring|Standard non-invasive respiration monitoring includes telemetry of heart rate and rhythm, respiratory rate, blood pressure, CF-LVAD flow, and oxygen saturation (SpO2) via pulse oximetry.
16006602|NCT02838342|Drug|Metronomic cyclophosphamide|50 mg oral tablet, one tablet per day, every day for 6 months; abort if progression or intolerance
16006603|NCT02838342|Drug|Interferon-alpha|3 months of treatment from the 4th cycle metronomic cyclophosphamide : subcutaneous injection, initial dose of 3 MIU three times a week. The dose may be adjusted as tolerated to achieve a T cell counts greater than 500 / mm3
16006604|NCT02838329|Other|warming of ropivacaine for BT|
16006605|NCT02838329|Drug|Ropivicaine|
16006606|NCT02838316|Drug|Autologous Muscle Derived Cells for Gastro-Intestinal Repair (AMDC-GIR)|Autologous muscle derived stem cells
16006607|NCT02838303|Other|Organophosphate|Chlorpyrifos 50% plus cypermethrin 5%, WHO Class II: Moderately hazardous
16006608|NCT02838303|Other|Placebo|Multineem, WHO Class U: Unlikely to present acute hazard in normal use
16006609|NCT02838290|Other|Induction|Participants will be randomly assigned (computer generated straight away after clicking the link to the research) to one of 4 experimental conditions: stress at work, dealing with a patient's death, managing stress at work or all topics together. Each module includes brief reflection parts and quizzes. Participants will be asked to fill in an online survey just before the induction and a week after. The survey is about current occupational distress and organizational factors.
16006610|NCT02838290|Other|Control group|Participants in the control group will be asked to fill in an online survey, but will not have any task at time-1. However, participants in the control group will be invited to complete induction programme after time-2 (a week time after time-1) in ensure the same expectations in both, experimental and control, groups.
16006611|NCT02838264|Drug|PF-06463922|Single oral dose of PF-06463922 50 mg on Day 1 of Period 1 and Day 5 of Period 2
16006612|NCT02838264|Drug|PF-06463922|Single oral dose of PF-06463922 75 mg on Day 1 of Period 1 and Day 5 of Period 2
16006613|NCT02838264|Drug|PF-06463922|Single oral dose of PF-06463922 100 mg on Day 1 of Period 1 and Day 5 of Period 2
16006614|NCT02838264|Drug|PF-06463922|Highest safe single oral dose (mg) of PF-06463922 identified in the previous cohorts will be administered on Day 1 of Period 1 and Day 5 of Period 2
16006615|NCT02838264|Drug|Itraconazole|200 mg oral dose of itraconazole on Days 1 to 11 during Period 2
16006616|NCT02838251|Other|No intervention|
16006617|NCT02838238|Drug|Capecitabine|
16006618|NCT02838238|Drug|Placebo|
16006619|NCT02838225|Drug|Docetaxel, Doxorubicin|
16006620|NCT02838225|Drug|Docetaxel, Doxorubicin, Cyclophosphamide|
16006621|NCT02838212|Drug|adverse drug reaction|drug-related death
16006622|NCT02838199|Device|SAPIEN 3|
16006623|NCT02838199|Procedure|SAVR|
16006624|NCT02838186|Procedure|retroflexion|examination of the right colon with scope retroflexion
16006625|NCT02838186|Procedure|forward view|examination of the right colon in forward view
16006626|NCT02838173|Procedure|serratus plane bloc : Ropivacaine 2mg/ml (0,3ml/kg)|
16006627|NCT02838173|Procedure|tissue infiltration : Ropivacaine 2mg/ml (0,3ml/kg)|
16006628|NCT02838173|Procedure|serratus plane bloc : placebo|
16006629|NCT02838173|Procedure|tissue infiltration : placebo|
16006630|NCT02838160|Behavioral|Routine Care|After baseline measurement, Group 1 did not receive any intervention or education.
16006631|NCT02838160|Behavioral|Routine care Plus the designed booklet|Group 2 received only the designed booklet without any participation in the oral presentation.
16006632|NCT02838160|Behavioral|Routine care Plus the designed booklet Plus participation in oral presentations|Group 3 participated in oral presentations 14 days after completing self-study booklet. Interactive, standardized and mandatory oral presentations were held five times to ensure maximum attendance of the three nursing shifts.
16006633|NCT02838160|Behavioral|Routine care Plus the designed booklet Plus participation in oral presentations Plus clinical teaching in bedside|The Group 4 received clinical teaching in bedside after completing self-study booklet and a series of interactive, standardized and mandatory 90-120-minute oral presentations.
16006634|NCT02838147|Device|FreeStyle sensors.|Patients with normal OGTT (4 normal values) - will be allocated to 2-week period to FreeStyle sensors.
16006635|NCT02838147|Device|Glucometer|Patients with pathological OGTT - 1 abnormal value Patients with pathological OGTT - 2 abnormal value
16006636|NCT02838134|Other|Rocuronium|A bolus of 0.7 mg/kg rocuronium is administered just after tracheal intubation and then an infusion of rocuronium (0.3 to 0.4 mg/kg) is started when post-tetanic count (PTC) is more than 0 and titrated towards PTC 1-2.
16006637|NCT02838134|Other|No additional Rocuronium|No additional rocuronium is administered after tracheal intubation.
16006638|NCT02838121|Drug|Aclasta|Aclasta once annually for 2 years
16006639|NCT02838121|Drug|Placebo|No IV aclasta
16006640|NCT02838095|Behavioral|Nap|A 1-hour daytime nap opportunity
16006641|NCT02838082|Behavioral|Sleep Hygiene Protocol|Sleep Hygiene Protocol involving 1) Improved sleep environment 2) Enhanced Circadian Stimuli 3) Increased Daytime Activation (blue light therapy, daytime light exposure and daytime sleep restriction) 4) Adjusted morning ADL routines and 5) Restricted Caffeine intake
16006642|NCT02838082|Behavioral|Standard of Care|All standard of care procedures in a specialized traumatic brain injury inpatient rehabilitation unit
16006643|NCT02838069|Biological|Injection (2x106 ASC/5ml).|Injection of Autologous adipose derived stem cells (2x106 ASC/5ml). The patient of this group will receive one single administration of the cells and will be followed for 12 months. A final follow up visit will occur at Month 24.
16006644|NCT02838069|Biological|Injection (10x106 ASC/5ml).|Injection of Autologous adipose derived stem cells (10x106 ASC/5ml). The patient of this group will receive one single administration of the cells and will be followed for 12 months. A final follow up visit will occur at Month 24.
16006645|NCT02838069|Other|Placebo|Injection of placebo 0.5% glucose in saline with 4.5% alb/5ml The patient of this group will receive one single administration and will be followed for 12 months. A final follow up visit will occur at Month 24.
16006646|NCT02838056|Drug|epidural injection|drug combination: 2% lidocaine 17 ml + 2 ml alfentanil (544 mcg x 2 = 1088 mcg) + 7% sodium bicarbonate 2.3 ml (1.9 mEq) + 0.1mg epinephrine (1:200000)
16006647|NCT02838043|Dietary Supplement|Probio'Stick|A combination of the probiotic strains Lactobacillus helveticus and Bifidobacterium longum
16006648|NCT02838030|Drug|L-arginine|3 gr per day
16006649|NCT02838030|Drug|Placebo (for L-arginine)|3 gr per day
16006650|NCT02838030|Drug|acetylsalicylic acid|3 gr per day
16006651|NCT02838017|Device|Tissue Adhesive|
16006652|NCT02838017|Device|Sterile strips|
16006653|NCT02838004|Device|IOL MINI WELL READY|IOL MINI WELL READY
16006654|NCT02837991|Drug|CDX-014|
16006655|NCT02837978|Drug|Tacrolimus|Tacrolimus capsule: 0.5mg to 1mg, po, twice per day (Bid)，adjusted by its concentration in blood or due to patient response. Then may titer down until the endpoint.
16006656|NCT02837978|Drug|MTX|MTX：5mg to 15mg, po, once per week (Qw) until the endpoint or adjusted due to unacceptable toxicity develops.
16006657|NCT02837965|Drug|treatment with topical superpotent corticosteroid therapy|
16006658|NCT02837965|Drug|treatment with systemic therapy (methotrexate)|
16006659|NCT02837965|Drug|treatment systemic therapy (prednisone)|
16006660|NCT02837965|Drug|treatment with systemic therapy (prednisone)|
16006661|NCT02837965|Drug|treatment with systemic therapy (doxycycline)|
16006662|NCT02837952|Drug|FDC IBU/APAP 250 mg/500 mg|FDC IBU/APAP 250 mg/500 mg
16006663|NCT02837952|Drug|Placebo|Placebo
16006664|NCT02837939|Drug|Human derived Transfer factor|"One dose (the content of one amp.) of lyophilised drug contains:
~Leucocyte dialysatum 200 x 10 to the power of 6 (Lyophilized dialysate from 200 million leukocytes) pH = 7.8 to 9 after reconstitution (dissolving) of drug
~To be administered subcutaneously as follows:
~12 doses TF in total:
~3 x TF in first week: day 1,3,5
~2 x TF in week 2: day 8 , 11
~1 xTF in week 3 and 4 : day 15, 22
~1 x TF once a month up to 6 month"
16006665|NCT02837939|Drug|Aqua pro injectione 4ml ampules for subcutaneous injection|"12 doses in total:
~3 doses in first week: day 1,3,5
~2 doses in week 2: day 8 , 11
~1 dose in week 3 and 4 : day 15, 22
~1 dose once a month up to 6 month"
16006666|NCT02837926|Other|questionnaire|
16006667|NCT02837926|Biological|Gardasil vaccine|
16006668|NCT02837926|Biological|Cervarix®|
16006669|NCT02837913|Device|VitaHeat underbody heating mattress|Use of VitaHeat underbody heating mattress will be used for the intervention arm to reduce hypothermia post operatively
16006670|NCT02837900|Drug|TPX-100 200 mg 4 times weekly for 4 weeks|Ea. subject will received active TPX-100 200mg in the Left knee
16006671|NCT02837900|Drug|TPX-100 200 mg 4 times weekly for 4 weeks|TPX-100 100mg Right
16006672|NCT02837887|Behavioral|Computerized Cognitive Behavior Therapy|Undergo computerized cognitive behavior therapy
16006673|NCT02837874|Procedure|Isoperistaltic|Same direction of peristalsis between stomach and jejunum, efferent loop of jejunum is located on the distal part of remnant stomach
16006674|NCT02837874|Procedure|Antiperistaltic|Reverse direction of peristalsis between stomach and jejunum, efferent loop of jejunum is located on the proximal part of remnant stomach
16006675|NCT02837861|Drug|Routine Nutritional Support plus supplemental IV amino acids|Enteral nutrition as tolerated Plus supplemental IV AA infusion to meet the target of approximately 1.5-2.0gm protein/kg/day total starting within 24 hours of injury for 5 days.
16006676|NCT02837861|Other|Routine Nutritional Support|Enteral nutrition as tolerated.
16006677|NCT02837848|Procedure|Coactivation Strengthening|Coactivation strengthening implies a recruitment of the pectoralis major and the latissimus dorsi while performing regular strengthening.
16006678|NCT02837848|Procedure|Regular Strengthening|Regular strengthening implies external rotation, internal rotation, flexion and abduction of the gleno-humeral joint and scapular protraction and retraction of the scapulothoracic joint strengthening.
16006679|NCT02837835|Drug|ceftazidime|20 mg/kg of body weight followed by 60 mg/kg/day
16006680|NCT02837835|Drug|ceftazidime|20 mg/kg over 30 min every 8 h
16006681|NCT02837822|Device|Spinal cord stimulator|Spinal cord stimulator is a reversible and minimally invasive neuromodulation device used for the treatment of various diseases related to chronic pain, including CRPS and FBSS. Briefly, this technology uses electrical pulses to generate action potentials in nerve cells that induce paresthesias (buzzing or tingling sensations) in the affected limb and can relieve pain.
16006682|NCT02837822|Procedure|Implantation of a spinal cord stimulator|The electrical pulses are induced by one or more electrodes surgically implanted into the epidural space. These electrodes are usually placed under the skin in the abdomen or upper buttock.
16006683|NCT02837809|Radiation|Low dose CT|annual CT vs biennial CT
16006684|NCT02837796|Procedure|transobturator tape|
16006685|NCT02837783|Drug|Linaclotide|Oral, once daily
16006686|NCT02837783|Drug|Placebo|Oral, one daily
16006687|NCT02837770|Drug|Diclofenac Eye Drops|One drop of Diclofenac 0.1% will be instilled 45' prior to the IVI.
16006688|NCT02837770|Drug|Pacebo pill|Pacebo pill will be administered 4 hours before the IVI.
16006691|NCT02837770|Drug|Pacebo pill|Pacebo pill will be administered 4 hours before the IVI.
16006692|NCT02837770|Drug|Artificial Tears|One drop Artificial Tears will be instilled 45' prior to the IVI.
16006693|NCT02837757|Other|Biological samples|blood and tumor tissue samples
16006694|NCT02837744|Device|Axiostat®|Axiostat Chitosan Hemostatic dressing belongs to an advanced class of wound dressing that stops bleeding within few minutes of application by providing an active mechanical barrier.
16006695|NCT02837731|Device|Treatment Starling SV monitor|A dynamic assessment of fluid responsiveness will be performed at every clinical decision point for the first 72 hours of study enrollment. Fluid responsiveness will be assessed using a passive leg raise (PLR) and Starling SV hemodynamic monitor to guide corresponding treatment.
16006696|NCT02837718|Procedure|bupivakain % 0,5|Bupivacaine 0,5% The study method was a step-up/step-down sequence model where the dose for following patients was determined by the outcome of the preceding block. The starting dose of bupivacaine was 5 mL per nerve. In the case of block failure, the dose was increased by 0.5 mL per nerve. Conversely, block success resulted in a reduction in dose by 0.5 mL per nerve. Each of the three nerves was treated as a separate entity. Dose adjustments were made to each nerve individually. The volume dose was increased in 0.5 mL at every 5 consecutive cases regardless of the result of the previous block in order to minimize bias occurence. A blinded assistant assessed sensory and motor blockade at 5-min intervals up to 30 min.
16006697|NCT02837705|Other|blood draw|
16006698|NCT02837692|Drug|JNJ-42847922 10 milligram (mg)|JNJ-42847922 will be administered as single tablet of 10 mg, orally, once on Day 1.
16006699|NCT02837692|Drug|JNJ-42847922 20 mg|JNJ-42847922 will be administered as 1 tablet of 20 mg, orally, once on Day 1.
16006700|NCT02837692|Drug|JNJ-42847922 40 mg|JNJ-42847922 will be administered as 2 tablets of 20 mg, orally, once on Day 1.
16006701|NCT02837692|Drug|JNJ-42847922 60 or 80 mg|JNJ-42847922 will be administered as 3 or 4 tablets of 20 mg, orally, once on Day 1. Dose to be determined from Cohort 3, Period 1.
16006702|NCT02837679|Other|Geriatric Follow up|
16006703|NCT02837666|Dietary Supplement|Supplementation with Spirulina maxima|Supplementation with Spirulina maxima (4.5 g/d) in capsules during 6 weeks.
16006704|NCT02837666|Other|Washout|2 weeks washout period to each study subject to avoid any possible carryover effect.
16006705|NCT02837666|Other|Supplementation with placebo|Supplementation with placebo (4.5 g/d) in capsules during 6 weeks.
16006706|NCT02837666|Other|Isoenergetic diet|All participants will have a personal isoenergetic diet according to their height, weight, body composition and daily physical activity during 14 weeks
16006707|NCT02837666|Other|Exercise program|Participants are going to exercise five days a week with the following protocol: Between 5 and 10 min of heating exercise, Between 20-30 min anaerobic exercise and 20-30 min of aerobic exercise (cardiovascular exercise): walking, jogging, running and/or cycling, Three days a week aerobic intensities will be between 60% and 80% and two days between 70% and 90% of the maximum heart rate reserve, and five final minutes of stretching.
16006708|NCT02837653|Behavioral|Physical Activity Counselling|
16006709|NCT02837653|Other|Therapeutic Exercise for LBP|
16006710|NCT02837653|Other|Superficial Thermotherapy|
16006711|NCT02837640|Drug|levodopa-carbidopa|sinemet 200/50 1/2 tablet b.i.d. for 2 days and then t.i.d for 6 months
16006712|NCT02837627|Other|Tube feeding|During the study period, enteral feeds will be administered according to different tube feeding modalities: bolus feeding followed by the removal of the feeding tube; bolus tube feeding with permanence of the feeding tube for the whole post-prandial period; continuous feeding over a 3-hour period.
16006713|NCT02837614|Drug|dexamethasone acetate|1 milliliter of dexamethasone (4milligram) administered in the deltoid muscle before commencement of surgical procedure
16006714|NCT02837614|Drug|submucosal dexamethasone injection|Local anesthesia was achieved using 2% lignocaine hydrochloride and 1:100 000 adrenaline and a standard technique was followed to block Inferior alveolar, lingual and long buccal nerve in all patients. In Group B patients, 1 ml of dexamethasone was administered in submucosa. Investigators divided 1 ml Dexamethasone is into 0.4 milliliter, 0.3 milliliter and 0.3 milliliter parts. Following the local anesthesia, each part of dexamethasone was injected submucosally in the buccal, lingual and retromolar region around the tooth to be extracted. Bone removal done around the tooth using a round bur under copious 0.9% normal saline irrigation and tooth elevated. The flap was sutured using three simple interrupted 3-0 black braided silk suture. All patients were given amoxicillin 500 milligram every 8 hours orally for 5 days, and 500 milligram of paracetamol postoperatively.
16006715|NCT02837614|Procedure|Third molar surgery|Surgical access was gained through standard Terrence Ward's incision to raise a full thickness mucoperiosteal flap. Bone removal done around the tooth using a round bur under copious 0.9% normal saline irrigation. The tooth sectioned at cemento-enamel junction whenever required and a Coupland elevator is used to elevate tooth or fragmented tooth out of socket. The socket examined for any debris and sharp bony margins smoothened. The empty socket was irrigated copiously and flap was sutured using three simple interrupted 3-0 black braided silk suture.
16006716|NCT02837614|Drug|Amoxicillin and paracetamol|Amoxicillin 500 milligram every 8 hours orally for 5 days, and 500 milligram of paracetamol postoperatively (every 6 hours 1 tablet for 2 days).
16006717|NCT02837601|Device|AirSeal® Insufflation System (AIS)|The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® iFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port). The device enables peritoneal access with a novel mechanism to maintain pneumoperitoneum without a mechanical seal. Specifically, the AirSeal® System creates a pressure barrier within the proximal housing of the cannula which acts as an invisible seal to maintain pneumoperitoneum during the course of surgery. It utilizes a re-circulation and filtration control unit (AirSeal® iFS) designed specifically for the AirSeal® Access Port to create and maintain the pressure barrier.
16006718|NCT02837588|Device|Hyperthermy treatment with MJS electrode|30 patients who are diagnosed Pelvic pain with myofascial syndrome by gyneacologist or urologist goes to Pelvic Floor Physiotherapist for 4 session with hyperthermy treatment with MJS electrode at pelvic floor trigger points
16006719|NCT02837575|Biological|VCL-HB01|Investigational Product
16006720|NCT02837575|Other|Phosphate-buffered saline|Placebo
16006721|NCT02837562|Other|Slit lamp eye examination|All participants in the trial will undergo a slit lamp eye examination
16006722|NCT02837549|Other|Occupational therapy treatment|This intervention includes various thermal modalities, manual therapy, Physiotouch (Healthy Life Devices Ltd) and education
16006723|NCT02837536|Other|Horizontal iCare|IOP of the right eye will be measured using the iCare tonometer held in the horizontal position first and then in the vertical position.
16006724|NCT02837536|Other|Vertical iCare|IOP of the right eye will be measured using the iCare tonometer held in the vertical position first and then in the horizontal position.
16006725|NCT02837510|Behavioral|Standard smoking cessation counseling|Participants will discuss reasons for quitting, the model of smoking as a learned habit, triggers for smoking, and trigger management; receive brief training in how to manage withdrawal symptoms and relapse prevention counseling and receive the NCI Clearing the Air self-help smoking cessation booklet. The target quit date (TQD) session will be scheduled to occur up to 2 weeks following the pre-quit session. Participants will then meet with a smoking cessation counselor for a 15 minute booster counseling session. During the first week following TQD there will be two monitoring visits to closely monitor abstinence. Weekly thereafter for four weeks, participants will attend a brief booster counseling session.
16006726|NCT02837497|Other|ICU-RESUS CPR Improvement Bundle|"Point-of-care CPR training
~Post-cardiac arrest educational debriefings"
16006727|NCT02837484|Other|NuTech Affinity™ Membrane|NuTech Affinity™ Membrane is an aseptically produced hypothermically stored amniotic membrane patch.
16006728|NCT02837471|Device|PiezoRx medical grade pedometer|"Participants will be asked to freely use the PiezoRx medical grade pedometer for 12 weeks.
~Participants have access to a personal account created online and can record the daily steps count and physical activity.
~Participants will receive the standard care by the FrancoForme Cardiovascular rehabilitation and prevention program"
16006729|NCT02837458|Device|High-Frequency|high-Frequency electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
16006730|NCT02837458|Device|Sham Stimulation|Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
16006731|NCT02837445|Device|PHC ON|Eligible patients randomized after optimization phase to PHC ON for 6 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator
16006732|NCT02837445|Device|PHC OFF|Eligible patients randomized after optimization phase to PHC OFF for 6 months. Patients continue standard or modified anti-hypertension medical regime at discretion of the investigator.
16006735|NCT02837419|Behavioral|Health related Quality of life EQ-5D|Quality of Care
16006736|NCT02837393|Procedure|Ureteral catheterization|During ureteral catheterization, urine samples will be obtain from each kidney
16006737|NCT02837380|Drug|FF|FF is a dry white powder blended with lactose. It is the first strip of DPI. Per blister contains 100 mcg of dose
16006738|NCT02837380|Drug|VI/UMEC|VI and UMEC bromide combination is a dry white powder blended with lactose and magnesium stearate. It is the second strip of DPI. Per blister contains 25 mcg/62.5 mcg of VI/UMEC dose
16006739|NCT02837367|Dietary Supplement|Administration of supplements containing methyl-donors|Administration of supplements containing methyl-donors: betaine, 5-MTHF (L-5-methyltetrahydrofolate), Vitamin B12, choline bitartrate, ALA (alfa-linolenic acid), EPA (eicosapentaenoic acid), DHA(docosahexaenoic acid)
16006740|NCT02837354|Other|No intervention|
16006741|NCT02837341|Device|Philips®Vital Sign Device - Camera-based system (Prototype)|"Respiratory rates monitored via camera-based system and capnography simultaneously The Philips Vital Sign Device will record chest movements by camera. The program will use an algorithm to convert the chest movements into the respiratory rate"
16006742|NCT02837328|Drug|Oral Magnesium Supplement|400 mg Magnesium Citrate 1x daily for 12 weeks
16006743|NCT02837328|Drug|Placebo|Placebo pill resembling 400 mg Magnesium Citrate 1x daily for 12 weeks
16006744|NCT02837315|Behavioral|Brief Motivational Intervention (BMI)|This session includes a discussion related to harm reduction and the student's autonomy to make decisions about the information provided in the session; a marijuana use decisional balance exercise; personalized marijuana-related feedback, and goal-setting. Elements included in the feedback are: (a) comparison of the student's perception of how much college students use marijuana and actual student norms, (b) a comparison of the student's marijuana use vs. norms, (c) drug-related problems experienced, (e) money spent on marijuana, and (f) alcohol norms and consequences if participants indicated they also drink alcohol. Participants discuss the personalized feedback with the clinician and review protective behavioral strategies if she or she indicates interest.
16006745|NCT02837315|Behavioral|Substance-Free Activity Session (SFAS)|The clinician initiates a discussion of the student's college and career goals. Students discuss the values that motivate them as well as how marijuana use may interfere with their ability to accomplish these goals. Students then receive information on graduation rates and income benefits for those who attend and excel in college. They receive personalized feedback on (a) the requirements for their major and intended career, (b) a list of extracurricular activities tailored to their goals, (c) a graph showing time they allocate to their activities, (d) information on stress and depressive symptoms (if applicable) and possible adaptive coping responses and (e) a list of substance-free recreational activities in which they would like to start or continuing engaging.
16006746|NCT02837315|Behavioral|Relaxation Session|The session includes a clinician-led diaphragmatic breathing exercise, followed by a progressive muscle relaxation protocol (~30 minutes). At the end of the session, students are asked about their reaction to the relaxation techniques and are provided with relaxation training handouts.
16006747|NCT02837302|Drug|Livact|Daily dose of 12.45g of branched-chain amino acid containing 3.4g of L-valine, 5.7g of L-leucine, and 2.9g of L-isoleucine over 6 months.
16006748|NCT02837289|Other|Therapy taping|Therapy taping follows an anatomical pattern from the femur until tibia for correction of dynamic valgus with therapy taping.
16006749|NCT02837289|Other|Placebo taping|Placebo taping follows a different anatomical path without tension, eliminating all therapeutic process elements
16006750|NCT02837263|Radiation|Stereotactic body radiotherapy (SBRT)|"SBRT treatment will consist of 40-60 Gy delivered in five fractions prescribed to the planning target volume (PVT). Image guidance with MRI, megavoltage CT or cone beam CT scans would be required.
~SBRT will be initiated on Day 0. This should be initiated within 4 weeks of signing informed consent. An additional 2 weeks will be allowed if necessary due to SBRT treatment planning."
16006829|NCT02836639|Drug|Etoposide|Etoposide 400 mg/m2 from day -5 to day -4
16006751|NCT02837263|Drug|Pembrolizumab|Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. KeytrudaTM (pembrolizumab) has recently been approved in the United Stated for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilumumab and, if BRAF V600 mutation positive, a BRAF inhibitor.
16006752|NCT02837250|Behavioral|Pos4Health|This is a personalized, interactive, patient-centered Internet intervention targeting nonadherence to ART among substance users living with HIV.
16006753|NCT02837250|Behavioral|Patient Education|This is a patient education website with content about nonadherence to ART pertinent to substance users living with HIV.
16006754|NCT02837237|Drug|KBP-5074|"In Part 1 of the study, non-HD patients with severe CKD in Cohort 1 will receive a single oral capsule dose of KBP-5074 on Day 1 following a fast between 2 and 4 hours.
~In Part 2 of the study, HD patients with severe CKD will receive a single oral capsule dose of KBP-5074 following a fast between 2 and 4 hours. The dose of KBP 5074 will be administered on Day 1 immediately following a dialysis session."
16006755|NCT02837224|Device|The Situate Detection System|The Situate Detection System for locating surgical sponges
16006756|NCT02837211|Behavioral|Tapered Low Calorie Diet|"All participants will start with a 3 week run-in period during which they are fed a diet at 1.4 x their resting metabolic rate (kcal). Participants who are weight stable at the end of run in and are randomized to the Tapered Diet Arm will undergo the following 24 week feeding study intervention.
~The difference between a participant's run-in period energy intake and low-calorie prescribed energy intake (1000 kcal for women; 1200kcal for men) will be divided by six. At weekly intervals from weeks 1-6, daily caloric intake will be decreased by this fixed amount, reaching the final daily caloric goal (1000 kcals for women and 1200 kcals for men) by the end of the 6th week. Participants will present twice per week during weeks 1-6 to receive food that sums to that week's prescribed calorie level.
~From weeks 7-24, these participants will then follow a traditional low-calorie diet, still presenting for food pickups twice per week at a stable caloric level during this period."
16006757|NCT02837211|Behavioral|Traditional Low-Calorie Diet|"All participants will start with a 3 week run-in period during which they are fed a diet at 1.4 x their resting metabolic rate (kcal). Participants who are weight stable at the end of run in and are randomized to the Traditional Diet Arm will undergo the following 24 week feeding study intervention.
~Immediately following run-in, these participants will start a low-calorie diet (1000 kcal per day for women; 1200kcal for men) Participants will present twice per week during weeks 1-24 to receive food that sums to that week's prescribed calorie level."
16006758|NCT02837198|Drug|FYU-981|
16006759|NCT02837198|Drug|Topiroxostat|
16006760|NCT02837185|Procedure|Botulinum Toxin injection|Botulinum toxin injection for cervical dystonia subjects (as part of clinical care)
16006761|NCT02837185|Other|Physiological measures|These include TMS and EMG measurements
16006762|NCT02837172|Other|Diffusion Weighted Imaging (DWI)|"MDS-UPDRS,Montreal Cognitive Assessment, PDQ-39, DTI imaging (MRI), and neurological examination.
~Expert evaluation: Record review, PD Medical History and PD Family History Form, the Montreal Cognitive Assessment, PDQ-39. standard, full, neurological examination, and MDS-UPDRS"
16006763|NCT02837159|Other|mHealth application|Dietary and physical activity recommendations trough a mobile application
16006764|NCT02837146|Biological|Tocilizumab (TCZ)|Induction phase: TCZ subcutaneously (162 mg weekly) from baseline to week 24
16006765|NCT02837146|Drug|Methotrexate (MTX)|Induction and maintenance phase: Methotrexate 15-20 mg/week from baseline to week 54
16006766|NCT02837133|Behavioral|integrated yoga program|the program as a one-time session for 3 hours as a component of a Stress Management Education program
16006767|NCT02837107|Dietary Supplement|Mind Master|80ml Mind Master / day for 8 weeks
16006768|NCT02837107|Dietary Supplement|Placebo|80ml a look-alike Placebo / day for 8 weeks
16006769|NCT02837094|Drug|C19-A3 GNP|C19A3 GNP intradermal microinjectable solution of human C19A3 proinsulin peptide coupled to gold.
16006770|NCT02837081|Other|Prospective audit strategy of antimicrobial stewardship|applying prospective audit as a different strategy of antimicrobial stewardship
16006771|NCT02837081|Other|preauthorization strategy of antimicrobial stewardship|applying preauthorization as one strategy of antimicrobial stewardship
16006772|NCT02837068|Device|Wheelchair handrail compensator|Patients were treated by wheelchair handrail compensator for six times per week during the four-weeks treatment, with each treatment lasting at least 60 minutes, and follow up by eight weeks. The handrail compensator would help the paralysis upper limb kept the shoulder joint stretch forward, the elbow joint extend, the forearm in pronation, the wrist in flection and the fingers extend.
16006773|NCT02837068|Device|Ordinary wheelchair|Patients were treated by ordinary wheelchair for six times per week during the four-weeks treatment, with each treatment lasting at least 60 minutes, and follow up by eight weeks.The ordinary handrail could prevent the disable arm from sinking, but could not help the upper limp keep a normal position.
16006774|NCT02837055|Device|VivaSight intubation|patients are intubated with an endotracheal tube with an integrated camera
16006775|NCT02837055|Device|conventional intubation|patients are intubated with a conventional endotracheal tube
16006776|NCT02837042|Drug|Pembrolizumab|Pembrolizumab will be administered intravenously every 3 weeks.
16006777|NCT02837029|Other|Laboratory Biomarker Analysis|Correlative studies
16006778|NCT02837029|Biological|Nivolumab|Given IV
16006779|NCT02837029|Radiation|Yttrium Y 90 Glass Microspheres|Given IA
16006780|NCT02837016|Device|Wearable biofeedback|
16006781|NCT02837016|Behavioral|Relaxation Treatment|group-based relaxation treatment based on mindfulness meditation principles
16006782|NCT02837003|Drug|Aspirin|Discontinuation of aspirin at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion.
16006783|NCT02837003|Drug|Thienopyridine|Discontinuation of thienopyridine at 3 months after the Ultimaster sirolimus-eluting stent implantation by the physician's discretion.
16006784|NCT02836990|Device|Prevena Incision Management System|A negative pressure system which holds incision edges together and removes exudate and debris from site to prevent surgical wound infections
16006785|NCT02836990|Device|Dermabond|A surgical skin adhesive used to prevent surgical wound infections
16006830|NCT02836639|Drug|Bendamustine|Bendamustine 200 mg/m2 starting dose on day -3 and -2
16006786|NCT02836977|Drug|tegafur-uracil|Eligible patients will receive tegafur-uracil orally at a dose of 400mg/day (100mg/Cap., 2 capsules each time, twice a day) and folinic acid 30mg/day (15mg/Tab., 1 tablet each time, twice a day) for one year.
16006787|NCT02836964|Device|Dental Implant|Dental implant
16006788|NCT02836951|Other|Withdrawal of blood|Withdrawal of blood
16006789|NCT02836938|Other|Collection of exhaled breath volatile organic compounds|
16006790|NCT02836925|Drug|Ledipasvir+Sofosbuvir|"Patients with genotype 1 or genotype 4 Ledipasvir 90 mg + Sofosbuvir 400 mg
~12 weeks in previously untreated infected patients
~24 weeks for previously treated patients with uncertain subsequent retreatment options"
16006791|NCT02836925|Drug|Sofosbuvir+Velpatasvir|"Patients with genotype 2 or genotype 3 Sofosbuvir 400 mg + Velpatasvir 100 mg
~· 12 weeks of treatment"
16006792|NCT02836912|Other|Exercise|Besides the same information for the education group, exercise of upper extremity without loading, exercise of lower extremity, and training of respiratory muscles are used for the exercise group
16006793|NCT02836899|Drug|Nitric Oxide|Inhaled nitric oxide will be administered in a final concentration of 80 ppm. The treatment will begin at the onset of the cardiopulmonary bypass until to 24h after Intensive Care Unit (ICU) admission, including 2-4 hours of weaning from nitric oxide and careful hemodynamics monitoring.
16006794|NCT02836899|Other|Placebo|This is the placebo group. Nitrogen will be added instead of nitric oxide.
16006795|NCT02836873|Drug|Bexagliflozin|Bexagliflozin tablet, 20 mg
16006796|NCT02836873|Drug|Placebo|Placebo (inactive) tablet to match the active comparator
16006797|NCT02836860|Other|Tactile stimuli|Both groups will receive tactile stimuli: hand touch on the right and left lumbar multifidus muscles at L4-5
16006798|NCT02836847|Procedure|biological test|mutation and signal pathway activation status analysis
16006799|NCT02836847|Drug|GEMOX|Conventional chemotherapy:gemcitabine and oxaliplatin
16006800|NCT02836847|Drug|Cetuximab|
16006801|NCT02836847|Drug|Trastuzumab|
16006802|NCT02836847|Drug|Gefitinib|
16006803|NCT02836847|Drug|Lapatinib|
16006804|NCT02836847|Drug|Everolimus|
16006805|NCT02836847|Drug|Sorafenib|
16006806|NCT02836847|Drug|Crizotinib|
16006807|NCT02836834|Biological|JS001|Dose escalation study evaluating three dose levels (1, 3 and 10 mg/kg) of JS-001.Each of the 3 dose levels will use 2 dose schedules: single dose, and repeated doses every 2 weeks. Subjects will be assigned to a dose schedule in the order of study entry.
16006808|NCT02836821|Drug|Apatinib Mesylate Tablets|apatinib was administered in the morning after an overnight fast of at least 10 h
16006809|NCT02836821|Drug|Rifampicin Capsules|rifampicin was administered in the morning 2 hours after breakfast
16006810|NCT02836808|Behavioral|CAIPaDi|Patients are attended in 1 day by 9 specialists (endocrinologist, diabetes educators, nutritionist, psychologist, dentists, psychiatrist, physical activity specialist, foot care and ophthalmologist). They are attended in 4 monthly visits. After the initial phase, patients come back to the Center at 1 and 2 years for evaluation and reinforcement.
16006811|NCT02836795|Biological|humanized anti-PD-1 monoclonal antibody Toripalimab (JS001)|humanized anti-PD-1 monoclonal antibody (JS001) is a programmed death-1 (PD-1) immune checkpoint inhibitor antibody, which selectively interferes with the combination of PD-1 with its ligands, PD-L1 and PD-L2, resulting in the activation of lymphocytes and elimination of malignancy theoretically.
16006812|NCT02836782|Procedure|Blood sample withdrawal|Blood withdrawal for HIV-DNA or HCV resistance test
16006813|NCT02836769|Behavioral|Rehabilitation Consult (RC)|The RC was designed to foster key contributors to self management in the participants. The RC is administered by a rehabilitation professional and consists of an initial one-hour face-to-face consult and follow-up appointment(s) 2-12 weeks later, either telephone or face-to-face. The initial consult consists of orientation, consultation, goal-setting, teaching cognitive strategies, introduction to online resources/action planning/planning coping responses, review/implementation intentions/scheduling follow-up. The follow-up consists of a reminder, reorientation, checking of progress on goals and plans, re-planning as necessary, and discharge or scheduling of further follow-up as necessary.
16006814|NCT02836743|Drug|Circadin|Slow-release melatonin
16006815|NCT02836743|Drug|Placebo|
16006816|NCT02836730|Procedure|Low back pain surgery|
16006817|NCT02836717|Device|sacral nerve modulation|electric stimulation of the sacral nerve using an implanted electrode and stimulator
16006818|NCT02836704|Drug|INSULIN GLARGINE|"Pharmaceutical form: solution
~Route of administration: subcutaneous injection"
16006819|NCT02836704|Drug|metformin|"Pharmaceutical form: table or capsule
~Route of administration: oral administration"
16006820|NCT02836704|Drug|acarbose|"Pharmaceutical form: table or capsule
~Route of administration: oral administration"
16006821|NCT02836691|Device|EKG (electrocardiogram)|Analysis of the heart rate variability with an electrocardiogram with a commercial device adapted to asthmatic patients using 12 leads, a respiratory band and a pulseoximeter.
16006822|NCT02836678|Biological|Ridge splitting, immediate implant, Nanobone with PRF.|"Dental implant (is a surgical component that interfaces with the bone of the jaw or skull to support a dental prosthesis).
~Alloplast bone graft material (Nanobone)
~PRF platelet rich fibrin. (second-generation Platelet rich plasma where autologous platelets and leucocytes are present in a complex fibrin matrix to accelerate the healing of soft and hard tissue)."
16006823|NCT02836678|Biological|Ridge splitting, immediate implantand PRF.|"Dental implant (is a surgical component that interfaces with the bone of the jaw or skull to support a dental prosthesis).
~PRF platelet rich fibrin. (second-generation Platelet rich plasma where autologous platelets and leucocytes are present in a complex fibrin matrix to accelerate the healing of soft and hard tissue)."
16006824|NCT02836665|Procedure|Telemedicine for dermatological emergency patients|"Study-related photographs of the skin lesion made by a tablet and anamnesis data are uploaded to the hospital information system medico. Those data can directly be processed by the dermatological investigator in charge who enters his diagnosis and his therapy proposal without being on site."
16006825|NCT02836652|Device|HeartMate II (HMII)|Left Ventricular Assist Device
16006826|NCT02836652|Drug|Warfarin|(INR Target 2.0-2.5, median 2.25, per standard of patient care)
16006827|NCT02836652|Drug|acetylsalicylic acid (ASA) therapy|(81mg/day)
16006828|NCT02836639|Drug|Busulfan|Busulfan 0.8 mg/kg four times per day from day -7 to day -5
16006831|NCT02836626|Procedure|deep fascial mobilization|Pelvic and abdominal myofascial release techniques as described by Barnes will be performed to facilitate independent mobility between tissue layers as needed following the direction of palpated fascial tension. Following this, direct scar mobilization techniques as described by Manheim will be done, applying a stretch in the direction of palpated restriction . This involves applying deep pressure whose force and direction is dictated by the tightness the therapist palpates and the subject reports. These are each held until a release is felt (defined as a sudden relaxation of tissue tension), usually 60-120 seconds. Total treatment time will last 25 minutes. Treatments will include all the above techniques but the therapist will tailor each treatment to address palpated restrictions. Subjects will be instructed to carry on their normal routines between sessions and will not be given any home interventions. Treatment sessions will total four to occur within a three week time period.
16006832|NCT02836626|Procedure|superficial fascial mobilization|This group will undergo four 25-minute sessions of gentle superficial effleurage to the abdomen and posterior trunk followed by superficial skin rolling to the scar. Each treatment session will be terminated a) after 25 minutes or 2) when the patient asks to stop due to discomfort. Reasons for termination will be documented. Subjects will be instructed to carry on their normal routines between sessions and will not be given any home interventions. Treatment sessions will total four to occur within a three week time period.
16006833|NCT02836613|Biological|Galcanezumab|Administered SC
16006834|NCT02836600|Drug|LY3039478|Administered orally
16006835|NCT02836587|Behavioral|Balance training|The interventional program will last 8 weeks with the intensity of two 60-minutes lectures a week. Training sessions will be delivered by a physiotherapist to small groups of patients (3-5). Participants will receive individualized exercises which will be focused on main 4 types - stance exercises, gait and transition exercises and strength exercises especially focused on muscle strength of the lower extremities. The difficulty level will be increased progressively after participant's ability to complete each exercise independently (e.g. eyes closed, exercises on balance equipment - wobble board, foam etc., addition of a secondary cognitive task). The training session will consist of a ten-minute warm-up followed by five-minute stretching, 30 minutes of balance training and 15 minutes of stretching and relaxation.
16006836|NCT02836574|Biological|Renal Autologous Cell Therapy (REACT)|Autologous selected renal cells (SRC).
16006837|NCT02836561|Other|Telephone message|A pre-visit telephone intervention describing availability of long-acting reversible contraceptives at time of uterine evacuation
16006838|NCT02836548|Drug|Vorinostat|vorinostat 360 milligram once daily
16006839|NCT02836535|Behavioral|qualitative interviews|
16006840|NCT02836522|Behavioral|Assessment of Health-Related Quality|Demographic Questionnaire, ANCHOR HRSI, FACT-G, MDASI, Patient ECOG PS, PGIC
16006841|NCT02836509|Drug|Paracetamol|1000 mg Paracetamol in 150 ml normal saline given as a slow intravenous infusion over 5 minutes.
16006842|NCT02836509|Drug|Ibuprofen|800 mg Ibuprofen in 150 ml normal saline given as a slow intravenous infusion over 5 minutes
16006843|NCT02836496|Drug|Mepolizumab 300 mg|Mepolizumab is available as lyophilized powder for injection reconstituted with Sterile Water for Injection, just prior to use.
16006844|NCT02836496|Drug|Placebo matching mepolizumab|Placebo is available as 0.9% sodium chloride solution
16006845|NCT02836496|Drug|Active OCS capsules (5 mg prednisolone or prednisone)|All subjects will be provided with 2 bottles of blinded OCS capsules, one containing 5mg OCS capsules (active OCS treatment) and a second one containing matching placebo capsules (placebo OCS treatment). These will be dispensed to each subject at each scheduled clinic visit and as needed. Subjects with an increase in blood eosinophils above the pre-specified threshold will be instructed to start blinded OCS treatment from one of the bottles provided (active treatment) unless the subject's HES therapy has already been increased due to a symptom flare within the past 2 weeks.
16006846|NCT02836496|Drug|Placebo matching OCS capsules|All subjects will be provided with 2 bottles of blinded OCS capsules, one containing 5mg OCS capsules (active OCS treatment) and a second one containing matching placebo capsules (placebo OCS treatment). These will be dispensed to each subject at each scheduled clinic visit and as needed.A subject who does not reach the pre-specified blood eosinophil threshold with a similar blood draw date will be selected to initiate a placebo OCS treatment in a blinded manner, unless the subject's HES therapy has already been increased due to a symptom flare within the past 2 weeks.
16006847|NCT02836483|Drug|LCB01-0371 800mg, QD|Oral administration
16006848|NCT02836483|Drug|LCB01-0371 400mg, BID|Oral administration
16006849|NCT02836483|Drug|LCB01-0371 800mg, BID|Oral administration
16006850|NCT02836483|Drug|Tubes 3~5Tablet, QD|Oral administration
16006851|NCT02836483|Drug|Zyvox 600mg, BID|Oral administration
16006852|NCT02836483|Drug|LCB01-0371 1200mg, QD|Oral administration
16006853|NCT02836470|Drug|LB1148|A total of 700 mL of drug product will be administered orally as a split dose before surgery.
16006854|NCT02836470|Drug|Placebo|A total of 700 mL of placebo will be administered orally as a split dose before surgery.
16006855|NCT02836457|Drug|ELIQUIS (APIXABAN)|
16006856|NCT02836431|Drug|Dexmedetomidine 1mcg/kg Intranasal|DEX 1 mcg/kg Intranasal
16006857|NCT02836431|Drug|Dexmedetomidine 2mcg/kg Intranasal|DEX 2 mcg/kg Intranasal
16006858|NCT02836431|Drug|Dexmedetomidine 1mcg Intravenous|DEX 1 mcg/kg Intravenously
16006859|NCT02836418|Drug|ATYR1940|ATYR1940 at a dose no greater than 3.0 mg/kg administered via IV infusion over 90 minutes once weekly.
16006860|NCT02836405|Device|Transcranial Magnetic Stimulation|Single pulses of TMS as well as continuous theta burst stimulation (cTBS) will be applied to the motor cortex.
16006861|NCT02836392|Behavioral|Questionnaire|
16006862|NCT02836379|Other|No intervention|No intervention
16006863|NCT02836353|Drug|Somatostatin|Single dose of short acting Somatostatin (100mcg) pre Oral glucose tolerance test
16006864|NCT02836353|Drug|Rifaximin|1 week course of 400mg three times daily (TDS) pre Oral glucose tolerance test
16006865|NCT02836340|Drug|2-Iminobiotin|The Investigational Medicinal Product (IMP) under study is 2-IB, which is a biotin (Vitamin H or B7) analogue and a selective inhibitor of neuronal and inducible nitric oxide synthase (NOS).
16006866|NCT02836327|Other|Magnetic Resonance Imaging|Magnetic Resonance Imaging
16006867|NCT02836314|Other|Anorganic Bovine Bone Mineral (ABBM)|In the control group, periodontal intrabony defects were treated with ABBM alone.
16071155|NCT02374567|Drug|Moclobemide|
16006868|NCT02836314|Other|Anorganic Bovine Bone Mineral and Platelet Rich Fibrin (PRF)|In the test group, periodontal intrabony defects were treated with ABBM and PRF combination.
16006869|NCT02836301|Behavioral|Control ending - Uplifting|The control ending is emotionally uplifting. In this video, the decedent previously registered as an organ donor through online registration and discussed his decision with family. The scene cuts to the family affirming the deceased's wish. In the next scene, the donor family and recipient meet for the first time, ending with a plea from both parties for viewers to register for donation.
16006870|NCT02836301|Behavioral|Negative Consequences Ending|A sad ending where the decedent did not register or discuss their position with family; family is asked to consider donation as an option, but they do not agree. The patient with kidney failure misses the window of opportunity, and the final scene is of both families grieving at their respective family members' grave plots…a missed opportunity.
16006871|NCT02836301|Behavioral|Unresolved Ending|In this ending, the team checks for registration status, and while searching, the scene cuts to physicians discussing the death with family and whether they might consider preservation and organ donation. The video then cuts to the potential recipient and family hoping for a kidney transplant before it is too late. The story ends without resolution, leaving viewers to contemplate how they might respond in the same situation
16006872|NCT02836288|Drug|Ketamine|Ketamine 1.0 mg/kg mixed with syrup will be given by mouth once a day for 12 weeks.
16006873|NCT02836288|Other|Placebo|Placebo syrup will be given by mouth once a day for 12 weeks.
16006874|NCT02836275|Other|Diffusion/Perfusion-weighted Magnetic Resonance Imaging|
16006875|NCT02836262|Device|HIT Hip Replacement System|HIT Hip Replacement System
16006876|NCT02836249|Drug|TAF|TAF 25 mg tablet administered orally once daily
16006877|NCT02836249|Drug|TDF|TDF 300 mg tablet administered orally once daily
16006878|NCT02836249|Drug|TAF Placebo|TAF placebo tablet administered orally once daily
16006879|NCT02836249|Drug|TDF Placebo|TDF placebo tablet administered orally once daily
16006880|NCT02836236|Drug|TAF|TAF 25 mg tablet administered orally once daily
16006881|NCT02836236|Drug|TDF|TDF 300 mg tablet administered orally once daily
16006882|NCT02836236|Drug|TAF Placebo|TAF placebo tablet administered orally once daily
16006883|NCT02836236|Drug|TDF Placebo|TDF placebo tablet administered orally once daily
16006884|NCT02836223|Device|Interdental cleaning device|Water Flosser
16006885|NCT02836223|Device|Manual Tooth brush|Control
16006886|NCT02836210|Device|27-gauge vitrectomy wound construction|Conventional, 3-port pars plana vitrectomy with membrane peeling is performed for epiretinal membrane indication. Angled and straight trocar entry will be directly compared.
16006887|NCT02836197|Behavioral|Communication skills training|The general aim of the communication skills training program is to help physicians learn effective communication skills in contexts of high uncertainty. The training will last 30 hours, will be spread over 4 months. The training will be conducted by group of 3 subjects. The training will include mainly role-plays, theoretical information and modeling techniques. A training manual has been developed to increase content standardization and reduce potential group or trainee biases. The role-plays will be based on clinical cases brought up by the participants.
16006888|NCT02836184|Drug|Nicotinic Acids|Nicotinic acids is administered at an initial dosage of 50mg four times daily in the first week. If no significant side effects detected, the dosage will be titrated to 100mg five times daily within the second week and last to the end of study.
16006889|NCT02836184|Drug|Calcium Carbonate|Calcium Carbonate 500mg per oral, twice a day
16006890|NCT02836171|Drug|Apatinib Mesylate Tablets|apatinib was administered in the morning after an overnight fast of at least 10 h
16006891|NCT02836171|Drug|Itraconazole Capsules|rifampicin was administered in the morning 0.5 hours after breakfast
16006892|NCT02836158|Drug|R-IDARAM plus intrathecal chemotherapy|R-IDARAM comprised of rituximab 375 mg/m2 (day 1), idarubicin 10 mg/m2(day 2); dexamethasone 100 mg/m2 (12 h.infusion in day 2, 3 and 4); cytarabine 1 g/m2 (1 h. infusion in day 2); methotrexate 1.5 g/m2 (6 h. infusion in day 4 with folinic acid rescue). Intrathecal Immunochemotherapy comprised of rituximab 20mg, MTX 15mg, dexamethasone 5mg and Ara-c 50mg once a week.
16006893|NCT02836145|Other|Differentiation of hiPSCs to skeletal muscle progenitors|
16006894|NCT02836132|Behavioral|Weight Watchers Online|
16006895|NCT02836132|Behavioral|Experience Success Virtual Reality Platform|
16006896|NCT02836106|Other|Butter|Butter with jam and three slices of bread
16006897|NCT02836106|Other|Cheese|Cheese with jam and three slices of bread
16006898|NCT02836106|Other|Whipped cream|Whipped cream with jam and three slices of bread
16006899|NCT02836106|Other|Sour cream|Sour cream with jam and three slices of bread
16006900|NCT02836093|Behavioral|FACIT-Fatigue 52-point questionnaire|
16006901|NCT02836080|Behavioral|Integrated Collaborative Care Team (ICCT)|An integrated, collaborative pathway of needs-based services. ICCTs will offer a wide variety of services, including Solution-Focused Brief Therapy (SFBT) on a scheduled and walk-in basis, care navigators, various clinician-guided interventions, psychiatry, nurse practitioner services, access to primary care, and peer support, all co-located in youth-friendly, community-based clinics. For each intervention, standardized intervention protocols will be used.
16006902|NCT02836080|Other|Treatment as Usual (TAU)|Standard out-patient treatment provided at each participating hospital site. This typically entails referral to a psychiatrist at the participating hospital, who will provide assessment and treatment, with referral to appropriate services, guided by local treatment protocols.
16006903|NCT02836067|Behavioral|Counseling|Smoking cessation counseling
16006904|NCT02836067|Other|Smoking Cessation drugs|Medication to aid smoking cessation
16006905|NCT02836067|Procedure|Bronchoscopy|Bronchoscopy
16006906|NCT02836067|Procedure|Blood Draw|Screening and research blood draws
16006907|NCT02836067|Behavioral|Questionnaires|Behavioral questionnaires
16006908|NCT02836054|Procedure|lumbar puncture (LP)|
16006909|NCT02836054|Procedure|brain MRI|
16006986|NCT02835430|Procedure|Coronally advanced flap and PRF with DFDBA|• For Test site: i. Following pre-suturing of coronally advanced flap, DFDBA (Rocky Mountain Particulate Allograft) was placed over the exposed root and adjacent bone surface and subsequently covered by PRF membrane.
16007145|NCT02834260|Drug|Dexamethasone implant OZURDEX|
16006910|NCT02836041|Behavioral|questionnaires|"Pre-hospital sleep questionnaire completed (Brief Infant Sleep Questionnaire (BISQ)7 in children 0-3 years old; Children's Sleep Habits Questionnaire (CSHQ)8 in children 4 years and older). Subsequent Day(s):
~In-hospital sleep questionnaire completed between one and three times per subject (Sleep at MSK questionnaire (SAM), adapted from Sleep in a Children's Hospital (SinCH)9 by Dr. Lisa Meltzer). (Patients will be observed for up to 3 consecutive nights in total)."
16006911|NCT02836041|Device|actigraph|This device reliably measures sleep by monitoring the child's motion.
16006912|NCT02836028|Drug|Talazoparib|Talazoparib monotherapy 1mg/day orally
16006913|NCT02836028|Drug|Temozolomide|temozolomide 37.5 mg/m2 on days 1-5 of each cycle
16006914|NCT02836015|Behavioral|Shared Medical Visit|The Shared Medical Visits are a replacement for standard diabetic visits with PCP, and will occur completely in Spanish, the patients' preferred primary language. An interdisciplinary group including behavioral health, social work, pharmacy, MD, and diabetic educator will be involved in the visit. The focal point of the meeting is a 30 minute session in which all members are seated around a large table in the Midtown SMV area and each patient's blood sugars, labs, and medications are discussed in front of the entire group. Pertinent labs and vaccines are drawn/administered.
16006915|NCT02836002|Drug|Sulfadoxine-pyrimethamine (low dose)|- subcurative regimen (500mg/25mg)
16006916|NCT02836002|Drug|Piperaquine (low dose)|- subcurative regimen (480 mg)
16006917|NCT02836002|Drug|Sulfadoxine-pyrimethamine (high dose)|- curative regimen (1000mg/50mg)
16006918|NCT02836002|Drug|Piperaquine (high dose)|- curative regimen (960 mg)
16006919|NCT02836002|Biological|malaria challenge infection, P. falciparum 3D7|malaria challenge infection by P. falciparum 3D7-infected mosquito bites
16006920|NCT02836002|Drug|Atovaquone-proguanil|- curative regimen: 1000/400 mg, for 3 days
16006921|NCT02835989|Other|CP@Home|Community paramedics (CPs) will be assigned to visiting the participants for a first time the week following the initial EMS call. Participants will complete the informed consent process with a CP on their first visit. This visit will also include a full assessment and risk analysis that will take approximately 90 minutes and will be located in the participant's home. As a result of the initial visit, the CP will make all relevant clinical referrals and decisions based on predetermined @Home algorithms. A second visit will be made to the participant 2-4 weeks following the initial call for a streamlined follow-up and reassessment during a 30 minute period. A final visit will be made 6-8 weeks following the initial call for a final evaluation of their situation. It is anticipated the patient will be discharged from the CP@Home program at this point. If the patient calls EMS following the third visit, if they meet the inclusion criteria, they will be re-entered into the CP@Home program.
16006922|NCT02835976|Drug|Olesoxime|Olesoxime will be given orally on Day 1 as a 600-mg liquid suspension within 30 minutes after starting a standardized high-fat breakfast.
16006923|NCT02835963|Other|Data collection|Usual data collection
16006924|NCT02835950|Device|Therapeutic Intra-Vascular UltraSound (TIVUS™) System|"The TIVUS™ System generates high intensity, non-focused ultrasonic energy that is delivered through the wall of the pulmonary artery to achieve local nerve deactivation.
~Denervation in the pulmonary arteries (PDN) would be performed during right heart catheterization. The PDN procedure would be attempted in the main, right and left pulmonary arteries, close to the main bifurcation."
16006925|NCT02835937|Other|No-Transfuse|Patients will not receive an otherwise-indicated red blood cell transfusion
16006926|NCT02835924|Drug|Regorafenib|
16006927|NCT02835898|Other|Conventional periodontal treatment|Conventional routine periodontal treatment will be done for patients in test group
16006928|NCT02835885|Device|Digitmer High Voltage Stimulator model DS7A TENS unit|
16006929|NCT02835872|Other|dietary fiber|Fiber containing drink mixes and crackers to be consumed with meals (1g fiber/serving) three times per day for a total of 3 g fiber.
16006930|NCT02835859|Other|Dietary: saccharin|Assess the glycemic and hormonal responses to an oral glucose load preceded by an oral solution of NCASs (saccharin).
16006931|NCT02835859|Other|Estimate glucose absorptions|Indirectly estimate the rate of glucose absorption and gastric emptying by using 3-O-methyglucose (3-OMG) and acetaminophen, respectively.
16006932|NCT02835846|Drug|Estrogen Cream|Participants are provided a vaginal estrogen cream (i.e., Premarin Cream® 0.625 mg conjugated estrogen/gram) and instructed to use 0.5 grams with an applicator twice weekly for 12 weeks.
16006933|NCT02835833|Drug|Nintedanib|Nintedanib will be given twice daily at either 150 mg or 200 mg.
16006934|NCT02835833|Drug|Bevacizumab|Bevacizumab will be given at 15 mg/kg
16006935|NCT02835820|Dietary Supplement|Ketogenic Diet|12 week delivery of all meals/snacks (eucaloric) prepared by a registered dietician.
16006936|NCT02835807|Behavioral|Health Chat including Indoor Tanning|Participants in the intervention join a private Facebook group to participate in the Health Chat program. The group is not viewable to the public, including other Facebook users. The content of Health Chat is designed primarily for mothers, the participants in the group. Posts will occur twice daily for 12 months for a total of 720 posts. Each group will be hosted by a moderator who is responsible for managing the intervention goals and mothers' engagement. Mothers likely will not continuously engage with a social media campaign that is limited only to indoor tanning. To engage mothers in the Health Chat program, content addressing several major health and wellness topics relevant to adolescent girls and their mothers will be posted.
16006937|NCT02835807|Behavioral|Health Chat excluding Indoor Tanning|In the comparison condition, 25% of the posts will be about prescription drug abuse and misuse. Prescription drug abuse was selected as control content because it is a) completely unrelated to tanning, and b) an emerging issue of great interest and relevance to young adults in east Tennessee. This 25% segment of posts is the only difference between the intervention and comparison conditions.
16006938|NCT02835794|Drug|Omacetaxine|Comparison of different doses of omacetaxine in combination with azacitidine and G-CSF
16006939|NCT02835794|Drug|Azacitidine|Comparison of different doses of omacetaxine in combination with azacitidine and G-CSF
16006940|NCT02835794|Drug|G-CSF|Comparison of different doses of omacetaxine in combination with azacitidine and G-CSF
16006941|NCT02835781|Other|Acellular dermal matrix implantation|Acellular dermal matrix obtained from Central tissue bank, University Hospital Bratislava, will be used for acellular dermal matrix implantation.
16007027|NCT02835118|Drug|Surotomycin|Two oral doses of surotomycin in hard gelatin capsules totaling either 0.5, 1 or 2 g per day, for 14 days
16006942|NCT02835768|Other|Internet-based injury prevention program|"An injury prevention website serves as the Internet-based intervention providing two key topics: 1) Types of domestic injury, and 2) how to prevent different types of domestic injury. The domestic injury prevention information Home Safety Tips is divided into four subgroups according to various safety issues relevant to infants/children's age groups. Apart from a knowledge hub, the website incorporates additional functions of feedback counselling, video demonstration, online consultation, games, safety checklist and discussion forum."
16006943|NCT02835755|Other|Educational Intervention|Receive standard HPV and HPV vaccine information
16006944|NCT02835755|Other|Educational Intervention|Receive mHealth HPV vaccine intervention
16006945|NCT02835755|Other|Survey Administration|Ancillary studies
16006946|NCT02835742|Drug|Sargramostim|
16006947|NCT02835742|Drug|Placebo|
16006948|NCT02835729|Drug|Idarubicin|Chemotherapy
16006949|NCT02835729|Drug|Cytarabine|Chemotherapy
16006950|NCT02835729|Drug|Indoximod Freebase|IDO pathway inhibitor
16006951|NCT02835729|Drug|Indoximod HCL F1|IDO pathway inhibitor
16006952|NCT02835729|Drug|Indoximod HCL F2|IDO pathway inhibitor
16006953|NCT02835716|Drug|roflumilast|DALIRESP is used in adults with severe chronic obstructive pulmonary disease (COPD) to decrease the number of flare-ups or the worsening of COPD symptoms (exacerbations
16006954|NCT02835716|Biological|ustekinumab|STELARA is approved to treat adults 18 years and older with moderate or severe plaque psoriasis that involves large areas or many areas of their body
16006955|NCT02835703|Procedure|Surgical repair of coarctation of aorta|Surgical repair of coarctation of aorta with aortic arch hypoplasia under CPB
16006956|NCT02835690|Biological|Pembrolizumab|IV infusion
16006957|NCT02835677|Behavioral|Behavioral|Education and skills building, including problem solving, cognitive restructuring, and stress management
16006958|NCT02835664|Dietary Supplement|Nicotinamide Riboside (Niagen)|
16006959|NCT02835664|Dietary Supplement|Placebo|
16006960|NCT02835651|Dietary Supplement|Palmitic acid|Experimental products are enriched with C16:0
16006961|NCT02835651|Dietary Supplement|Stearic acid|Experimental products are enriched with C18:0
16006962|NCT02835638|Device|Adaptative Servo Ventilation|the ASV treatment will be observed during this study on the patients included
16006963|NCT02835625|Radiation|Synthetic Mammography + Digital Breast Tomosynthesis|Two-view tomosynthesis performed with GE Senoclaire 3D Breast Tomosynthesis.
16006964|NCT02835625|Radiation|Digital mammography|Two-view digital mammography performed with GE Senoclaire 3D Breast Tomosynthesis.
16006965|NCT02835612|Other|Early stimulation|Intervention Group: skin-to skin care by mother ( kangaroo care ) plus massage therapy by mothers. They will receive the tactile-kinesthetic stimulation by mothers from randomization until hospital discharge. Intervention performed exclusively by the mothers was based on studies regarding the application of skin stimulations and passive exercises in preterm infants
16006966|NCT02835612|Other|Conventional care|skin-to skin care by mother, kangaroo care. Standard care, according to the routine care of the NICU.
16006967|NCT02835586|Drug|Paclitaxel|Paclitaxel will be administered intra-arterially through an irrigating catheter to treat a diseased segment of superficial femoral artery and/or popliteal artery after stenting. Dosing will be based on the lesion surface area and will be calculated using the following formula : 22/7 x diameter (mm) x length (mm) x 3 µg/mm3
16006968|NCT02835560|Drug|Ilaprazole antisecretory drug of each quadruple therapy the Ilaprazole -based quadruple therapy|Ilaprazole -based quadruple therapy for 14 days: Ilaprazole 5mg bid, Bismuth Potassium Citrate 220mg bid, amoxicillin 1000mg bid, clarithromycin 500mg bid
16006969|NCT02835560|Drug|Esoprazole antisecretory drug of each quadruple therapy Esoprazole-based quadruple therapy|Esoprazole -based quadruple therapy for 14 days: Esoprazole 20mg bid, Bismuth Potassium Citrate 220mg bid, Amoxicillin 1000mg bid, Clarithromycin 500mg bid
16006970|NCT02835547|Other|Data collection|Risk factors will be collected retrospectively (5 years) and cardiovascular events prospectively (2 years)
16006971|NCT02835534|Drug|rhTNK-tPA|Dose:16mg; Mode of admin: Single bolus Enoxaparin or unfractionated heparin for anticoagulant therapy, clopidogrel and aspirin for antiplatelet therapy before fibrinolytic therapy.
16006972|NCT02835534|Drug|alteplase|Dose:50mg; Mode of admin: administered as an 8-mg initial IV bolus followed by an infusion of 42 mg over the next 90 minutes Enoxaparin or unfractionated heparin for anticoagulant therapy, clopidogrel and aspirin for antiplatelet therapy before fibrinolytic therapy.
16006973|NCT02835521|Procedure|Reception|
16006974|NCT02835521|Drug|Joint injection with triamcinolone hexacetonide|joint injection with corticosteroids
16006975|NCT02835508|Drug|JNJ-56021927 60 Milligram|JNJ-56021927 60 mg oral tablet.
16006976|NCT02835508|Drug|JNJ-56021927 120 Milligram|JNJ-56021927 120 mg as 2 tablets of 60 mg.
16006977|NCT02835508|Drug|JNJ-56021927 240 Milligram|JNJ-56021927 240 mg as 4 tablets of 60 mg.
16006978|NCT02835495|Behavioral|HELP Vets Intervention|This intervention involves a dietary weight loss program and an increase in caloric expenditure through moderate physical activity. The primary treatment objectives for the weight loss component of the intervention will be to decrease caloric intake in a nutritionally sound manner so as to produce a weight loss of approximately 0.3 kg per week for a total weight loss of 5-7%. The primary objective for the physical activity component of the intervention will be to promote an increase in home-based energy expenditure to an eventual goal of 180 min/week.
16006979|NCT02835495|Behavioral|Individual Education Program|Participants will receive two individual sessions with a nutritionist during the first 3 months. In these sessions, the nutritionist will cover basic aspects of healthy eating and activity to support weight loss, discuss existing community resources and increased physical activity and weight loss. These participants will also receive a monthly newsletter on topics related to healthy lifestyle.
16006980|NCT02835482|Procedure|Femtolaser surgery|
16006981|NCT02835482|Procedure|Phacoemulsification|
16006982|NCT02835469|Drug|Menotrophin|
16006983|NCT02835456|Device|Sharklet Catheter insertion|
16006984|NCT02835456|Device|Silicone Foley Catheter insertion|
16006985|NCT02835443|Device|Deep Brain Stimulation|Electrical stimulation of the dentate nucleus area of the cerebellum.
16007028|NCT02835118|Drug|Placebo|Two oral doses of placebo for surotomycin in hard gelatin capsules per day, for 14 days
16006987|NCT02835430|Procedure|Coronally advanced flap and PRF without DFDBA|. For Control site: i. Following pre-suturing of coronally avanced flap, exposed root and adjacent bone surface was covered by PRF membrane.
16006988|NCT02835404|Drug|Nedaplatin|Chemotherapy: Nedaplatin(NDP) 30-40mg/m2 iv., on day1, 4weeks as one cycle
16006989|NCT02835404|Radiation|Pelvic External Radiotherapy|patients received 20 Gy2.0/f, for 25-27f (SSD)with 8mv-X rays (SSD)
16006990|NCT02835404|Radiation|252-Cf Neutron Intracavitary Brachytherapy|total dose of reference point A was 4400cGy, in four times Transvaginal implant sessions during Pelvic External Radiations
16006991|NCT02835391|Device|PerClot|Haemostatic device for the control of bleeding from capillary, venous or arteriolar vessels by pressure, ligature or other conventional means is either ineffective or impractical.
16006992|NCT02835391|Device|Floseal, Surgicel, Surgiflo, Arista|Haemostatic device for the control of bleeding
16006993|NCT02835391|Procedure|Electrocautery/Diatermy|Procedure for the control of bleeding
16006994|NCT02835378|Other|No intervention|
16006995|NCT02835352|Other|Essential oils massages|
16006996|NCT02835352|Other|Oil massages|
16006997|NCT02835339|Drug|Magnesium sulfate 4g loading dose, 1g/hr infusion|
16006998|NCT02835339|Drug|Magnesium sulfate 6g loading dose, 2g/hr infusion|
16006999|NCT02835326|Behavioral|Exercise and Dietary Weight Loss|The EX+DWL intervention consists of group and individual exercise sessions, as well as, nutritional and dietary counseling. Bimonthly phone calls are made in the final year of the study to aid in maintenance of the program.
16007000|NCT02835326|Behavioral|Walk with Ease|The WWE 6 week program consists of health education lectures on arthritis self-management, a walking exercise portion, and at- home strength exercises. Participants will complete two consecutive WWE programs. Monthly and bimonthly phone calls are made to participants in months 4-12 and 12-24, respectively, to aid in maintenance of the program.
16007001|NCT02835313|Behavioral|FAST|Subjects participate in fast walking training 3x/week for 12 weeks.
16007002|NCT02835313|Behavioral|FAST+SAM|Subjects participate in fast walking training plus a step activity monitoring program 3x/week for 12 weeks
16007003|NCT02835313|Behavioral|SAM|Subjects participate in a step activity monitoring program 3x/week for 12 weeks
16007004|NCT02835300|Behavioral|CampAir|CampAir is a dynamic e-learning intervention to help adolescents with uncontrolled asthma to manage their illness and to improve their asthma control. CampAir consists of seven online modules with one module being completed each week over seven weeks. Each module provides a brief introduction to the topics and strategies focused on in that module followed by a set of interactive exercises and games for practice and personalized feedback.
16007005|NCT02835300|Behavioral|Information and Referral|The information and referral comparator condition will provide access to existing generic asthma education websites. They will also be referred to their medical providers for asthma. After the completion of the trial, all participants will have access to CampAir.
16007006|NCT02835287|Other|Protocol-based integrated care|The protocol-based integrated care, which will provide a standardized, combined, multi-component intervention according to clinical guideline treatment algorithms for diabetes and comorbidities in community clinics, will be delivered by trained primary care physicians, health managers, and nurses supported by diabetes specialists.
16007007|NCT02835274|Device|BSC Deep Brain Stimulation System with Directional Lead|
16007008|NCT02835261|Other|Sleep Restriction|Mild sleep restriction (-1.5 h/night) over a period of 6 weeks
16007009|NCT02835248|Other|Fall Detection|All participants will wear a device configured to detect falls.
16007010|NCT02835235|Drug|NNC9204-0530|Administered daily subcutaneously (s.c., under the skin)
16007011|NCT02835235|Drug|placebo|Administered daily subcutaneously (s.c., under the skin)
16007012|NCT02835222|Drug|Cytarabine|Given IV
16007013|NCT02835222|Drug|Daunorubicin Hydrochloride|Given IV
16007014|NCT02835222|Drug|Selinexor|Given PO
16007015|NCT02835209|Other|Work of breathing during SBT|Pulmonary function tests and work of breathing indices will be collected during the spontaneous breathing test.
16007016|NCT02835196|Device|Optical Elastography|To image skin thickness, Optical Coherence Elastography (OCE)-scanning of 6 body surface areas will be preformed using the Phase-Stabilized Swept Source Optical Coherence Elastography (PhS-SSOCE) system.
16007017|NCT02835196|Other|Visual Assessment|Skin thickness will be visually assessed clinically in 6 body surface areas using the the modified Rodnan Skin Score (mRSS). The mRSS uses a 0-3 scale, where 0 = normal, 1= mild thickness, 2 = moderate thickness, and 3 = severe thickness
16007018|NCT02835183|Device|iDECIDE|The iDECIDE app will be installed in study participant's smartphone. The app requests from study participants input on food consumed (included food's carbohydrate content), alcohol consumed (included alcohol's carbohydrate content) and exercise plans (including duration and intensity). Based on that input the app suggests insulin bolus dosing.
16007019|NCT02835183|Device|Insulin pump|Study participants will use during the study their own insulin pump and continuous glucose sensor. As inclusion criteria, investigators expect study participants to have been using their insulin pump and continuous glucose sensor for at least one year.
16007020|NCT02835170|Biological|Autologous immunoglobulin|Autologous immunoglobulin (total IgG) aseptically purified from the autologous plasma will be administered to the patients by intramuscular injection, once a week for 7 weeks (total 8 injections).
16007021|NCT02835170|Other|Placebo|"Saline will be administered to the patients by intramuscular injection, once a week for 7weeks (total 8 injections).
~(In addition, autologous immunoglobulin is colorless and odorless, injection volume is same between autologous immunoglobulin and saline)"
16007024|NCT02835144|Other|TIQAAM_therapy|The treatment program consists of TIQAAM therapy blocks to three priority areas: promoting change and motivation, relapse prevention and relapse management, and promote resource and euthymic activities to increase the abstinence motivation. The TIQAAM is based on behavioral approaches as well as motivational interviewing of Miller and Rollnick.
16007025|NCT02835144|Other|Psychoeducation|This intervention is a psychoeducation module pertaining to substance use disorders.
16007026|NCT02835131|Drug|Pasireotide|
16007142|NCT02834286|Drug|Eltrombopag|Eltrombopag 50 mg PO days 1-28
16007029|NCT02835105|Drug|Surotomycin|A single oral dose of either 0.5, 1, 2 or 4 g surotomycin in hard gelatin capsules
16007030|NCT02835105|Drug|Placebo|A single oral dose of placebo for surotomycin in hard gelatin capsules
16007031|NCT02835092|Other|Take Shape For Life Program|The Take Shape For Life (TSFL) Program group will be assigned to the Optimal Weight 5 & 1 Plan™ for weight loss. This group will have scheduled coaching sessions with a TSFL coach for the duration of the study.
16007032|NCT02835092|Other|Medifast Direct Program|The Medifast Direct Program (MEDD) group will be assigned to the Medifast Achieve™ Plan (4 & 2 & 1 Plan®) for weight loss. MEDD participants will have access to the services of the Medifast Nutrition Support Team.
16007033|NCT02835092|Other|Self-directed Control|The Self-directed Control Group will be assigned to a food-based, reduced calorie diet consistent with the 2015 Dietary Guidelines for Americans.
16007034|NCT02835079|Drug|Tamoxifen|
16007035|NCT02835066|Other|Integrated Fitness Assessment|Undergo function/fitness assessment
16007036|NCT02835066|Procedure|Psychosocial Assessment and Care|Undergo psychosocial health assessments
16007037|NCT02835066|Procedure|Quality-of-Life Assessment|Complete EORTC QLQ-C30 and QLQ-LC13 questionnaires
16007038|NCT02835053|Other|Frailty|Participants will be defined as frail based on the Johns Hopkins ACG Frailty Defining Diagnoses Indicator, which will be applied to available health administrative data in the 3 years preceding index hospital admission. If no frailty defining diagnoses are present participants will be defined as not frail
16007039|NCT02835040|Other|New model of service delivery|Introduction of a new CAP disease specific clinical team to ensure systematic implementation of standardized treatment protocols (similar to a clinical pathway) for interventions supported by Level-1 evidence.
16007040|NCT02835040|Other|Current practice|Interventions as determined by the treating General Medical team consistent with current usual practice.
16007041|NCT02835027|Procedure|Open versus endovascular surgery|Treatment for acute ischemia
16007042|NCT02835014|Behavioral|Mental Health Symptoms|Adolescents with T1DM will be asked to complete PHQ9 (depression screening), SCARED (anxiety screening) and UCLA PTSD (trauma screening)
16007043|NCT02835014|Behavioral|Self-efficacy regarding self-care and diabetes management|Adolescents with T1DM will be asked to complete the SEDM to asses self-efficacy for diabetes management
16007044|NCT02835014|Behavioral|Parenting Styles|Parents of adolescents with T1DM will be asked to complete the PSDQ to asses parenting style
16007045|NCT02835001|Procedure|Bronchoscopy|Two sequences of 30 minutes are necessary by patient
16007046|NCT02835001|Device|Lung Volume Reduction Coil (HEAT-LVRC)|Bronchoscopy with Heat-LVRC
16007047|NCT02834975|Drug|Pembrolizumab|Pembrolizumab on Day 1 of each cycle.
16007048|NCT02834975|Drug|Paclitaxel|"NACT: Paclitaxel on Day 1 of each cycle;
~ACT: Paclitaxel same as NACT OR; dose-dense option weekly per protocol."
16007049|NCT02834975|Drug|Carboplatin|Carboplatin IV on Day 1 of each cycle.
16007050|NCT02834962|Procedure|single bundle ACL reconstruction|anterior cruciate ligament reconstruction using single bundle technique
16007051|NCT02834962|Procedure|double bundle ACL reconstruction|anterior cruciate ligament reconstruction using double bundle technique
16007052|NCT02834949|Behavioral|Brief Motivational Intervention (BMI)|This session includes a discussion related to harm reduction and the student's autonomy to make decisions about the information provided in the session; an alcohol use decisional balance exercise; personalized alcohol-related feedback, and goal-setting. Elements included in the feedback are: (a) comparison of the student's perception of how much college students drink and actual student norms, (b) a comparison of the student's alcohol consumption vs. norms, (c) an estimate of the student's peak blood alcohol content in the past month, (d) alcohol-related problems experienced, (e) money spent on alcohol, and (f) calories consumed from alcohol. Participants discuss the personalized feedback with the clinician and review protective behavioral strategies if he or she indicates interest.
16007053|NCT02834949|Behavioral|Substance-Free Activity Session (SFAS)|The clinician initiates a discussion of the student's college and career goals. Students discuss the values that motivate them as well as how alcohol use may interfere with their ability to accomplish these goals. Students then receive information on graduation rates and income benefits for those who attend and excel in college. They receive personalized feedback on (a) the requirements for their major and intended career, (b) a list of extracurricular activities tailored to their goals, (c) a graph showing time they allocate to their activities, (d) information on stress and depressive symptoms (if applicable) and possible adaptive coping responses and (e) a list of substance-free recreational activities in which they would like to start or continuing engaging.
16007054|NCT02834949|Behavioral|Relaxation Session|The session includes a clinician-led diaphragmatic breathing exercise, followed by a progressive muscle relaxation protocol (~30 minutes). At the end of the session, participants will be asked about their reaction to the relaxation techniques and provided with relaxation training handouts.
16007055|NCT02834936|Drug|pyrotinib|
16007056|NCT02834923|Behavioral|Enhanced Engagement Protocol for CTH (EE-CTH)|EE-CTH integrates CTH with an efficacious, structured, motivational interview (MI)-informed protocol.
16007057|NCT02834923|Behavioral|Connection to Health (CTH)|CTH is a comprehensive SMS program that focuses on behavior change.
16007058|NCT02834910|Other|collection of bacterial sample|
16007059|NCT02834897|Radiation|EOS and CT Exam|EOS and CT Examen for pregnant women in the 8th month of pregnancy
16007060|NCT02834884|Genetic|RP-1828 IMMUcan|WES, lcWGS and RNAseq, multiplex IF and IMC
16007061|NCT02834884|Genetic|RP-1759 AYA/TYA|WES, RNAseq and EPIC array
16007062|NCT02834884|Genetic|RP-1843 Arcagen|NGS panel
16007063|NCT02834871|Device|Electromyogram|
16007064|NCT02834858|Biological|Umbilical Cord Mesenchymal Stem Cells|stem cell acquisition, processing and reinfection, to evaluate the efficacy by using umbilical cord mesenchymal stem cells
16007065|NCT02834858|Biological|saline|
16007066|NCT02834845|Drug|Sevoflurane|Sevoflurane %2-3 for general anesthesia maintenance
16007067|NCT02834845|Drug|Desflurane|Desflurane %6-8 for general anesthesia maintenance
16007068|NCT02834832|Device|PECVD coating|SiO2/SiC coatings will be applied to the surface of removable partial dentures and denture teeth.
16007069|NCT02834819|Drug|3% Nebulized Hypertonic Saline|
16007143|NCT02834286|Drug|Dexamethasone|Dexamethasone 40 mg IV/PO days 1-4
16007070|NCT02834806|Device|BioNIR Ridaforolimus Eluting Coronary Stent System|BioNIR Ridaforolimus eluting coronary stent system with modified delivery system
16007071|NCT02834793|Drug|Placebo|Participants will receive matching placebo in Randomization phase.
16007072|NCT02834793|Drug|Perampanel|Participants will receive perampanel in Randomization phase, open-label Extension A, and open-label Extension B.
16007074|NCT02834767|Device|Genioglossis Strength Trainer|The genioglossis strength trainer is a handheld device, manufactured in house, consisting of an outer tube, inner piston, and pressure loaded spring. The device can be set to a specific pressure resistance ranging from 10 to 40 Newtons. Users press against the inner piston with their tongues until the piston moves approximately 1/2 centimeter (and the inner pressure loaded spring depresses approximately 1/2 centimeter).
16007075|NCT02834767|Device|Placebo Genioglossis Strength Trainer|The placebo genioglossis strength trainer is a handheld device, manufactured in house, consisting of an outer tube, inner piston, and pressure loaded spring. Whereas the pressure loaded spring in the active trainer can be set to a wide range of pressures, the placebo trainer has a maximum resistance of 5 Newtons. The device is set to a specific pressure resistance of 5 Newtons at all times. Users press against the inner piston with their tongues until the piston moves approximately 1/2 centimeter (and the inner pressure loaded spring depresses approximately 1/2 centimeter).
16007076|NCT02834754|Drug|Vedolizumab|Vedolizumab is a monoclonal antibody developed by Millennium Pharmaceuticals, Inc for the treatment of ulcerative colitis and Crohn's disease. It binds to integrin α₄β₇. Blocking the α₄β₇ integrin results in gut-selective anti-inflammatory activity. Vedolizumab was been approved by the Food and Drug Administration (FDA) in 2014 for achieving clinical response, achieving clinical remission, and achieving corticosteroid-free remission in adult patients with moderately to severely active Crohn's disease. We believe that use of vedolizumab constitutes a non-significant risk to the research subject. The dose of vedolizumab administered is 300mg IV
16007077|NCT02834754|Drug|placebo|Currently there are no clinical guidelines and no standard of care for the maintenance of surgically induced remission. There are no medications that have consistently been proven to be efficacious at preventing recurrent Crohn's disease and as such, no active equivalent arm is being used. Due to the lack of effective prophylactic therapy, many physicians and patients opt not to initiate medical therapy after surgery, rather wait until Crohn's disease recurs, or wait to perform a post-operative colonoscopy within 6-12 months of surgery, and decide on initiating Crohn's disease therapy based on endoscopic Rutgeerts; score. Therefore, acknowledging that many patients are not administered post-operative maintenance medications, we feel the placebo arm is justified.
16007078|NCT02834741|Drug|NYX-2925|NYX-2925 is a small molecule that acts as an N-methyl-D-aspartate receptor (NMDAR) functional glycine-site partial agonist.
16007079|NCT02834728|Behavioral|telephone interview|
16007080|NCT02834715|Dietary Supplement|Stevia rebaudiana liquid extract|Sweetener made of liquid stevia self administered daily for 30 days
16007081|NCT02834702|Device|Sinew acupuncture|The subject is asked to be on sitting posture. The skin around the needling points is disinfected with a 75% alcohol swap. A tube-guided, sterilized, disposal needle is then inserted (at a small angle to the skin) into the acupoint at 0.5-1 cun (depending on point location and body size of the subject). No needle sensation (deqi sensation) is required. A piece of surgical adhesive tape will be applied to the needle immediately after insertion.
16007082|NCT02834702|Device|Sham acupuncture|The procedure in the sham acupuncture group will be as similar to that of the acupuncture group as possible. In the sham acupuncture group, however, a mock plastic needle guiding tube is tapped on the surface of each acupoint (Ashi point and traditional acupoints) to produce some discernible sensation. A piece of adhesive tape is immediately applied to fix the needle on the dermal surface tapped, without needle insertion. In addition, a plastic tube-guided needle is superficially inserted at the sham point at less than 5mm in depth.
16007083|NCT02834689|Behavioral|Walking|Walking on a treadmill at 3.5 METS for 50 minutes
16007084|NCT02834689|Behavioral|Seated Control|Sitting for 50 minutes
16007085|NCT02834676|Drug|Gelified Ethanol|Pain relief with chemonucleolysis by using gelified ethanol regard to age, sex, ASA score, and complications.
16007086|NCT02834663|Drug|Lucentis|Local anesthesia with T-caine with Saline irrigation. Routine eye drap was done by potadine-cotton ball. Lucentis injected to vitreous cavity, finally dressing.
16007087|NCT02834650|Other|Cardiac MRI with contrast|Cardiac MRI
16007088|NCT02834650|Other|Cardiac MRI without contrast|Cardiac MRI
16007089|NCT02834650|Other|Blood Test|Hematocrit, Creatinine, Troponin, BNP
16007090|NCT02834650|Other|Heart Rate|Holter Monitor
16007091|NCT02834650|Other|Pulmonary Function Test|Pulmonary Function Test
16007092|NCT02834650|Other|Genetic Testing|Genetic Testing
16007093|NCT02834650|Other|Repeat MRI scan|Repeat MRI scan
16007094|NCT02834637|Drug|bivalent HPV vaccine|head to head comparisons of different dose schedules and HPV vaccine types
16007095|NCT02834637|Drug|nonavalent HPV vaccine|head to head comparisons of different dose schedules and HPV vaccine types
16007096|NCT02834624|Drug|Poractant alfa|Randomized to receive Curosurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist.
16007097|NCT02834624|Drug|calfactant|Randomized to receive Infasurf as the surfactant to treat respiratory distress syndrome. Doses 3ml/kg. to be repeated as needed by determination of attending neonatologist
16007098|NCT02834611|Drug|Ceramide NanoLiposome|Intravenous administration of Ceramide NanoLiposome
16007099|NCT02834598|Device|high-density electroencephalography|Cerebral measurements from high-density electroencephalography while standard and deviant sounds are presented to the participant.
16007100|NCT02834585|Other|Ultrasound|
16007101|NCT02834572|Behavioral|All About Me|Assessment and algorithm to determine recommended HIV testing approach
16007102|NCT02834572|Behavioral|Control|HIV testing information
16007103|NCT02834559|Drug|5-fluorouracil and low molecular weight heparin|Intraoperative adjuvant application of 5-fluorouracil (5-FU) and low molecular weight heparin (LMWH) via intraocular infusion during routine pars plana vitrectomy (PPV).
16007104|NCT02834559|Drug|Placebo|Routinely used intraocular infusion with balanced salt solution (BSS) during routine pars plana vitrectomy (PPV).
16007144|NCT02834273|Behavioral|stroke education workshops|
16007105|NCT02834546|Biological|Sorafenib plasma concentration 4 weeks after treatment initiation|Sorafenib plasma concentrations will be assessed at 4, 8 and 16 weeks by high performance liquid chromatography. The pharmacology Unit of Bordeaux university hospital (Pr Molimard) is a French Center of reference for the dosage of TKI in the plasma
16007106|NCT02834533|Device|Lokomat|Lokomat (Hocoma Inc., Zurich, Switzerland)includes a treadmill, a BWSS and two powered gait orthosis robotic actuators with integrated computer-controlled linear actuators at each hip and knee joint . As compared to Lokomat-Nanos, the Pro device offers a VR through an Augmented Feedback Module, which provides instructive, stimulating, interactive, and direct feedbacks to enhance the patient's motivation by projecting his/her avatar while walking on a screen.
16007107|NCT02834507|Drug|Placebo|Matching placebo capsules
16007108|NCT02834507|Drug|BIA 3-202|Capsules containing nebicapone 75 mg or 150 mg
16007109|NCT02834507|Drug|Comtan®|Capsules containing entacapone 200 mg
16007110|NCT02834507|Drug|Sinemet®|levodopa/carbidopa (Sinemet®) dose patient used to take
16007111|NCT02834494|Procedure|3D Shear Wave Elastography (SWE)|Ultrasound imaging with Elastography will be performed at the inclusion (T0), after course 1 and course 2 respectively with anthracyclines, at the end of anthracycline treatment and at the end of taxane treatment.
16007112|NCT02834494|Biological|Biopsy|Optional biopsy of breast tumor under neoadjuvant chemotherapy after the course 2 of anthracycline.
16007113|NCT02834481|Device|ANI/NIPE|ANI/NIPE monitors is a continuous noninvasive measurement of the parasympathetic tone, as a component of the autonomous nervous system. It uses the tiny variations of heart rate induced by each respiratory cycle (natural or induced) to quantify parasympathetic tone (respiratory sinus arrhythmia).
16007114|NCT02834468|Drug|DEX Combined With RTX, CSA and IVIG|The investigators are undertaking a multicenter trial of 100 primary ITP adult patients from 5 medical centers in China. All participants receive dexamethasone (given orally at a dose of 40 mg per day for 4 days), rituximab (given intravenously at a dose of 500mg once), cyclosporin (given orally at a dose of 2.5-3 mg/kg per day for 28 days) and intravenous immunoglobulin (given intravenously at a dose of 5g per month for 6 months) for the treatment of adults newly diagnosed ITP patients.
16007115|NCT02834455|Device|Contrast-enhanced CT|50% of patients with unilateral pleural effusion will have performed a CE-CT
16007116|NCT02834455|Device|PET-CT|50% of patients with unilateral pleural effusion will have performed a PET-CT
16007117|NCT02834442|Drug|MT-7117|
16007118|NCT02834442|Drug|Placebo|
16007119|NCT02834416|Behavioral|Supervised Group Exercise|The exercise program will be delivered in a group format (4-8 participants per group) by a certified exercise specialist.
16007120|NCT02834416|Behavioral|Home Based Exercise|The exercise program will be executed independently by participants in a home-based setting. Home-based participants will be supported with remote health coaching and smartphone technology.
16007126|NCT02834390|Drug|Quizartinib|"[Induction period, Cycle 1] Once-daily repeated oral administration Day 8 to Day 21.
~[Induction period, Cycle 2] Once-daily repeated oral administration Day 6 to Day 19.
~[Consolidation period] Once-daily repeated oral administration Day 6 to Day 19."
16007127|NCT02834390|Drug|Cytarabine|"[Induction period, Cycle 1] Once-daily intravenous injection of 100 mg/m^2 cytarabine on Day 1 to 7.
~[Induction period, Cycle 2] Once-daily intravenous injection of 100 mg/m^2 cytarabine on Day 1 to 5.
~[Consolidation period] Twice-daily intravenous injection of 3.0 g/m^2 cytarabine at 12-hour intervals on Days 1, 3, and 5."
16007128|NCT02834390|Drug|Idarubicin|"Either Idarubicin or Daunorubicin will be used [Induction period, Cycle 1] Once-daily intravenous injection of 12 mg/m^2 idarubicin on Day 1 to 3.
~[Induction period, Cycle 2] Once-daily intravenous injection of 12 mg/m^2 idarubicin on Day 1 and 2."
16007129|NCT02834390|Drug|Daunorubicin|"Either Idarubicin or Daunorubicin will be used [Induction period, Cycle 1] Once-daily intravenous injection of 60mg/m^2 daunorubicin on Day 1 to 3.
~[Induction period, Cycle 2] Once-daily intravenous injection of 60mg/m^2 daunorubicin on Day 1 and 2."
16007130|NCT02834377|Other|Treatment algorithm targeting individual cardiac output|
16007131|NCT02834364|Drug|Encorafenib|450 mg p.o. once daily. One cycle is defined as 28 days
16007132|NCT02834364|Drug|Binimetinib|45 mg p.o. twice daily. One cycle is defined as 28 days
16007133|NCT02834351|Other|Muscle Biopsy|"A distal and proximal biopsy of the sartorius muscles ( 0.5 cm3 each) will be performed during surgery for saphenous vein withdrawal (cardiac group) or arterial bypass (PAD group) The samples are then treated with neurovascular and mitochondrial biology laboratory.
~the activity of the complex 1 is analyzed and compared between the 2 groups."
16007134|NCT02834338|Device|activity tracking for autofeedback|The intervention group receives an unblinded wristband. The handling of the activity trackers is explained to the patients and a predefined mobilization end-point (step-count) for the first five PODs is targeted. The target step-count was set at the 85% quartile obtained from a previous pilot study. The patients are assessed and monitored two times daily between 9 and 11 o'clock AM and between 3 and 5 o'clock PM by a surgical fellow or a study nurse throughout their hospital stay for read-out of the step count, assurance of the proper use and functioning, and for communication of the autofeedback.
16007135|NCT02834325|Procedure|mechanical ventilation|
16007136|NCT02834312|Drug|Estetrol|All treatments (E4 [2.5 mg, 5 mg, 10 mg, 15 mg] capsule) will be administered once daily (QD) per os for at least 12 consecutive weeks until the last biological assessments (Day 90 maximum) have been performed.
16007137|NCT02834312|Drug|Placebo|1 capsule will be administered QD per os for at least 12 consecutive weeks until the last biological assessments (Day 90 maximum) have been performed.
16007138|NCT02834299|Behavioral|DBT Guided Self-Help|DBT self-help manual plus six 30-minute therapy sessions for 12 weeks
16007139|NCT02834299|Behavioral|DBT Unguided Self-Help|DBT self-help manual without any therapy sessions for 12 weeks
16007140|NCT02834299|Behavioral|Self-Esteem-Focused Unguided Self-Help|Self-esteem focused self-help manual without any therapy sessions for 12 weeks
16007141|NCT02834286|Drug|Rituximab|Rituximab 100 mg weekly days 1, 7, 14, 21
16007146|NCT02834247|Drug|TAK-659|TAK-659 Tablets.
16007147|NCT02834247|Drug|Nivolumab|Nivolumab intravenous infusion.
16007148|NCT02834234|Genetic|comparative genomic analysis|DNA and RNA extraction will be performed in Lyon University hospital (genomic platform) using commercially available kit. Percentage of tumors cells will be controlled by stained section before extraction. The CGH arrays will be realized on frozen samples in Lille (genomic platform). Pangenomic Agilent array will be used. Micro-array include 180000 probes. Analysis will be performed in Lille (genomic platform / department of BioInformatics) with Marie Brevet. Data will be processed from the log2 transformed data into normalization with the WACA method. Then copy number variation will then be identified with Circular Binary Segmentation. Copy number variations will be called as gain or deletion according to the log2 ratio distribution and the percent of tumoral cells. Using matched tumoral and normal DNA will eliminate Copy Number Polymorphisms. We will construct non supervised hierarchical analyses to study the classification of peritoneal mesothelioma based on copy number variation
16007149|NCT02834221|Device|Real-time ultrasound-guided puncture|A 7 megahertz ultrasound linear probe will be used.
16007150|NCT02834221|Other|Anatomical landmark guided puncture|Anatomical landmark puncture
16007151|NCT02834208|Other|MRI (Magnetic resonance imaging)|
16007152|NCT02834208|Genetic|Polymorphism (SNP in DNA)|
16007153|NCT02834208|Genetic|quantitative measures of mRNA|
16007154|NCT02834208|Other|Neuropsychological assessment|
16007155|NCT02834182|Behavioral|IRMf|
16007156|NCT02834182|Behavioral|Mini International Neuropsychiatric Interview|
16007157|NCT02834182|Behavioral|Positive And Negative Syndrom Scale|
16007158|NCT02834182|Behavioral|Young Mania Rating Scale|
16007159|NCT02834182|Behavioral|Hamilton Depression Scale|
16007160|NCT02834169|Other|Non interventional|Data collection
16007161|NCT02834156|Other|LP in a seated position then LP in a lying position|
16007162|NCT02834156|Other|LP in a lying position then LP in a seated position|
16007163|NCT02834143|Other|No intervention|The is no intervention. This study is a descriptive one
16007164|NCT02834130|Behavioral|Evaluation of psychological and psychopathological|
16007165|NCT02834117|Other|natural cycle|Ovulation is not induced by drugs
16007166|NCT02834117|Drug|moderate ovarian stimulation|Ovulation is induced by recombinant follitropin alpha and recombinant choriogonadotropin
16007167|NCT02834104|Device|RMI|
16007168|NCT02834104|Other|myocardial biopsy|
16007169|NCT02834104|Biological|blood sample|
16007170|NCT02834091|Procedure|Hypnoanalgesia|
16007171|NCT02834078|Dietary Supplement|BGG|
16007172|NCT02834078|Other|Placebo|
16007173|NCT02834065|Device|Cardiopulmonary bypass machine|Routinely used cardiopulmonary bypass machine (standard of care) will be used to initiate circulatory arrest
16007174|NCT02834052|Drug|pembrolizumab|200mg pembrolizumab will be given intravenously on Day 1 of each 3-week cycle
16007175|NCT02834052|Drug|Poly-ICLC|"The maximum tolerated dose of Poly ICLC will be given twice weekly, in each 3-week cycle:
~Week 1, Days 1 and 4
~Week 2, Days 8 and 11
~Week 3, Days 15 and 18"
16007176|NCT02834039|Procedure|Tidal volume 6 ml/kgBW|Tidal volume 6ml/kgBW was given to subjects after endotracheal tube was inserted properly.
16007177|NCT02834039|Procedure|Tidal volume 10 ml/kgBW|Tidal volume 10 ml/kgBW was given to subjects after endotracheal tube was inserted properly.
16007178|NCT02834026|Other|Cicloergometry training|
16007179|NCT02834026|Other|No Cicloergometry training|
16007183|NCT02834000|Device|LiDCO rapid™ CNAP monitoring|LiDCO rapid™ CNAP monitoring allows through analysis of the arterial blood pressure trace to acquire information about CO, HR variability, SVR, SV and BIS during general anaesthesia.
16007184|NCT02833987|Drug|Apixaban (ATC B01AF02)|Exposure to apixaban (ATC B01AF02) will be defined as a new prescription for apixaban in the 30 days following the date of an incident VTE diagnosis.
16007185|NCT02833987|Drug|Dabigatran (ATC B01AE07)|Exposure to dabigatran (ATC B01AE07) will be defined as a new prescription for dabigatran in the 30 days following the date of an incident VTE diagnosis.
16007186|NCT02833987|Drug|Rivaroxaban (ATC B01AF01)|Exposure to rivaroxaban (ATC B01AF01) will be defined as a new prescription for rivaroxaban in the 30 days following the date of an incident VTE diagnosis.
16007187|NCT02833987|Drug|Warfarin (ATC B01AA03)|Exposure to warfarin (ATC B01AA03) will be defined as a new prescription for warfarin in the 30 days following the date of an incident VTE diagnosis.
16007188|NCT02833974|Drug|GSK2245035 Nasal Spray Solution|GSK2245035 Nasal Spray Solution 0.2 microgram (mcg)/mL delivering 10 ng GSK2245035 per actuation. A solution formulation in saline, preserved with Benzalkonium Chloride and Disodium Edetate.
16007189|NCT02833974|Drug|Placebo Nasal Spray Solution|Nasal Spray Solution as for GSK2245035 without active ingredient.
16007190|NCT02833961|Device|Magnetic resonance imaging|
16007191|NCT02833948|Drug|Acetylsalicylic acid|"Drug: Acetylsalicylic acid:
~75 - 100 mg OD (for first 90 days only in arm 1)"
16007192|NCT02833948|Drug|Clopidogrel|Drug: Clopidogrel 75 mg OD for first 90 days
16007193|NCT02833948|Drug|Rivaroxaban|"Drug: Rivaroxaban (Xarelto):
~10 mg OD (once-daily)"
16007194|NCT02833935|Behavioral|Physical Activity Intervention|"The PA intervention will be delivered in a virtual face-to-face format using the secure and confidential Remote Education, Augmented Communication, Training and Supervision online video-based software. Intervention participants will receive 8 PA sessions over 2 months (1/week), following collaborator specific telephone-based PA counselling protocol. The counsellor will individually tailor her approach to each participant by understanding the participant's past and current PA experiences, motives to be physically active, salient concerns and barriers regarding PA, and physical home environment. Throughout the intervention, the PA counsellor and participants will co-construct and collaboratively adapt the intervention with the participants."
16007195|NCT02833922|Behavioral|Women using Dot to avoid pregnancy|Women who have chosen to use Dot to prevent pregnancy will be followed for 13 cycles to assess perfect and typical use of the Dynamic Optimal Timing method.
16007196|NCT02833909|Other|surgery|
16007197|NCT02833896|Genetic|surgery|
16007200|NCT02833870|Behavioral|Musical intervention|
16007201|NCT02833870|Behavioral|Non-musical (cooking) intervention|
16007202|NCT02833870|Behavioral|Control with no intervention|
16007203|NCT02833857|Drug|Etelcalcetide|A single IV-bolus dose of 0.035 mg/kg etelcalcetide into the venous line of the dialysis circuit at the end of a hemodialysis session.
16007204|NCT02833844|Drug|Evolocumab|Dose of subcutaneous evolocumab QM
16007205|NCT02833844|Drug|Placebo|Dose of matching placebo QM
16007206|NCT02833831|Drug|ALS-008176|Participants will receive a single dose of ALS-008176 orally.
16007207|NCT02833831|Drug|Placebo|Matching Placebo will be administered.
16007208|NCT02833831|Drug|Moxifloxacin|Participants will receive a single dose of moxifloxacin 400 mg.
16007209|NCT02833818|Dietary Supplement|CAKE-intervention|Increased protein and energy supplementation and conversations
16007210|NCT02833818|Dietary Supplement|CAKE-control|nutrition according to established procedures
16007211|NCT02833805|Drug|Thymoglobulin|Day -9: 0.5 mg/kg Days -8 and -7: 2 mg/kg daily
16007212|NCT02833805|Drug|Fludarabine|Days -6 through -2: 30 mg/m^2 IV daily
16007213|NCT02833805|Drug|Cyclophosphamide|Days -6 and -5: 14.5 mg/kg IV daily Days 3 and 4: 50 mg/kg IV daily
16007214|NCT02833805|Radiation|Total body irradiation|Day -1: 200 centigray (cGy) in a single fraction
16007215|NCT02833805|Drug|Tacrolimus|Start on Day 5 through Day 365
16007216|NCT02833805|Drug|Mycophenolate mofetil|Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
16007217|NCT02833792|Drug|Human Mesenchymal Stem Cells and Lactated Riunger's Solution|Intravenous administration
16007218|NCT02833792|Other|Placebo|Intravenous administration
16007219|NCT02833779|Other|Individual exercises|
16007220|NCT02833779|Other|Group exercises|
16007221|NCT02833766|Drug|anti-EGFR-IL-dox|First-line treatment with anti-EGFR-IL-dox, given at a dose of 50 mg/m2 intravenous, on day 1 of each cycle, cycle length is 28 days
16007222|NCT02833753|Drug|Oxaliplatin|"Intraperitoneal oxaliplatin will be given along with standard chemotherapy FOLFIRI.
~Level 1: Oxaliplatin 25mg/m2 IP every 2 weeks on day #1 of chemotherapy . Level 2: Oxaliplatin 55mg/m2 IP every 2 weeks on day #1 of chemotherapy Level 3: Oxaliplatin 85mg/m2 IP every 2 weeks on day #1 of chemotherapy Level 4: Oxaliplatin 55 mg/m2 IP every 2 weeks on day #1 of chemotherapy (due to DLTs found)"
16007223|NCT02833740|Device|Click-MUAC prototype & regular MUAC tape|Screening of children using Click-MUAC and regular MUAC tape
16007224|NCT02833727|Other|Smoking|Smoking equal or greater than 10 pack/years; never smokers: lifelong history without smoking.
16007225|NCT02833701|Dietary Supplement|Ascorbic Acid|Given IV
16007226|NCT02833701|Biological|Bevacizumab|Given intravenously (IV)
16007227|NCT02833701|Other|Laboratory Biomarker Analysis|Correlative studies
16007228|NCT02833701|Other|Quality-of-Life Assessment|Ancillary studies
16007229|NCT02833688|Drug|dexmedetomidine|dexmedetomidine 2mg is diluted in 0.9% sodium chloride with the concentration of 4 ug ml-1 is administered with an loading dose of 0.5ug kg-1 of 10 min, and maintained with infusion rate of 0.5 ug kg-1 h-1. The infusion is ceased after the resection of the hepatic issues.
16007230|NCT02833688|Drug|0.9% sodium chloride|0.9% sodium chloride is administered with an loading dose of 0.5ug kg-1 of 10 min, and maintained with infusion rate of 0.5 ug kg-1 h-1. The infusion is ceased after the resection of the hepatic issues.
16007231|NCT02833662|Other|Measure of ODI and heart rhythm|Record nocturnal respiratory and cardiac parameters before and after surgery.
16007232|NCT02833649|Device|Toric Implantable collamer Lens|The toric implantable collamer lens (TICL) is conventionally indicated for the Correcting the refractive error in keratoconus using the TICL is an off label use of the lens.
16007233|NCT02833636|Procedure|ACEF score|
16007234|NCT02833623|Behavioral|Short-message-based Re-education|
16007235|NCT02833623|Behavioral|conventional education|
16007236|NCT02833610|Drug|Denosumab Q4W|
16007237|NCT02833584|Drug|Paracetamol|Paracetamol 500 mg x 1 tablets according to patient's body weight
16007238|NCT02833584|Drug|Placebo|Placebo 500 mg x 1 tablets according to patient's body weight
16007239|NCT02833558|Device|PuraStat®|PuraStat® gel is applied through a safe catheter delivery system (via endoscope) over the bleeding point
16007240|NCT02833558|Procedure|Electrocautery|Electrocautery (coagulation current) to stop bleeding during ESD
16007241|NCT02833545|Device|Ozone gas|Injection of ozone gas intra articularly
16007242|NCT02833545|Drug|Steroid injection|Injection of steroids (diprospan) intra articularly
16007243|NCT02833532|Device|Volus/Powerfill|Maximum: 22ml
16007244|NCT02833519|Behavioral|group exercise|"Group training supervised by Physiotherapists from Copenhagen University Hospital, Rigshospitalet. 70 minutes sessions twice a week for 12 weeks.
~The training consists of 10 minutes of warm up (Borg scale 7-10), 20 minutes of fitness training on exercise bike, tread mill or cross-trainer (Borg scale 11-15), 25 minutes of muscle training and 15 minutes stretching/relaxation, (Borg scale 6).
~The intensity of the training follows national recommendations on physical activity for pregnant women, which recommends moderate physical activity or more depending on the pregnant woman's fitness level prior to pregnancy.
~The pregnant women´s general practitioners are informed about the intervention and who is participating in the project.
~A weekly supportive email."
16007245|NCT02833506|Other|Laboratory Biomarker Analysis|Correlative studies
16007246|NCT02833506|Biological|Recombinant NY-ESO-1 Protein|Given recombinant NY-ESO-1 protein SC
16007247|NCT02833506|Drug|Sirolimus|Given PO
16007248|NCT02833480|Drug|Fluticasone group|
16007249|NCT02833480|Drug|Budesonide group|
16007250|NCT02833480|Drug|Formoterol group|
16007251|NCT02833454|Procedure|direct insertion anterior cruciate ligament reconstruction|ACL reconstruction based on direct insertion of ACL.
16007252|NCT02833454|Procedure|single bundle anterior cruciate ligament reconstruction|anterior cruciate ligament reconstruction using single bundle technique
16007253|NCT02833454|Procedure|double bundle anterior cruciate ligament reconstruction|anterior cruciate ligament reconstruction using double bundle technique
16007254|NCT02833441|Behavioral|Peer Support|
16007453|NCT02831920|Other|CEUS and targeted biopsies|
16007454|NCT02831920|Other|MRI and targeted biopsies|
16007255|NCT02833428|Device|Biomedical equipment (Eclipse Nim, Medtronic®)|"It is the principal investigator (coordinator investigator moving on the website of the Pitié-Salpêtrière) that will install bedside biomedical equipment for the project (Eclipse Nim, Medtronic®) The term of monitoring will depend of length of stay in the PACU (the post anesthesia care unit) Gaston Cordier and will not exceed 72 hours.
~• Patients will be reviewed at 6 and 12 months for conventional control with establishing a ASIA score (American Spinal Cord Injury Association). Of SEP (Somatosensory evoked potentials) and MEP(Motor Engine Potentials) will be performed in the laboratory at 6 and 12 months (electrophysiology laboratory Pitié-Salpêtrière). They are part of the traditional support in the context of spinal cord trauma."
16007256|NCT02833415|Drug|[U-13C3] glycerol|Ingestion of [U-13C3] glycerol based on human's body weight such as (50 mg/kg body weight).
16007257|NCT02833415|Drug|Empagliflozin|Active drug
16007258|NCT02833415|Drug|Placebo (for Empagliflozin)|Placebo tablet manufactured to mimic EMPA 10 mg tablet.
16007259|NCT02833402|Device|InterStim Therapy|Sacral Neuromodulation, delivered by the InterStim® System, offers long-term control of bladder control and bowel control symptoms through modulation of the nerves that help control the pelvic floor and lower urinary tract.
16007260|NCT02833389|Drug|Placebo|UTTR1147A matching placebo will be administered SC.
16007261|NCT02833389|Drug|UTTR1147A|UTTR1147A will be administered SC.
16007262|NCT02833376|Other|alcohol antisepsis|
16007263|NCT02833376|Other|chlorhexidine antisepsis|
16007264|NCT02833350|Drug|GDC-0853|Participants will receive GDC-0853 at low, mid, or high doses, orally once or twice daily for 12 weeks in Cohort 1 or 2.
16007265|NCT02833350|Drug|Adalimumab|Participants will receive adalimumab, subcutaneously Q2W starting on Day 1 for 12 weeks.
16007266|NCT02833350|Drug|Folic Acid|Participants will receive stable background therapy of folic acid of at least 5 mg total dose weekly (or equivalent) as per investigator's discretion.
16007267|NCT02833350|Drug|MTX|Participants will receive stable background therapy of MTX 15-25 mg/week (oral or parenteral; for participants entering the trial on MTX doses 15 mg/week, doses as low as 7.5 mg/week are allowed only if there is clear documentation in the medical record that higher doses were not tolerated or that the dose of MTX is the highest acceptable dose based on local clinical practice guidelines).
16007268|NCT02833350|Drug|Placebo|Participants will receive placebo matched to adalimumab, subcutaneously Q2W and/or placebo matched to GDC-0853, orally once or twice daily for 12 weeks in Cohort 1 or 2.
16007269|NCT02833337|Radiation|Cone-beam computed topography|This study used a retrospective database of preexisting data that included patients treated as part of routine periodontal and oral surgery therapy for each patient's needs. All the patients signed an inform consent approving using their radiographic data for research purposes.
16007270|NCT02833324|Behavioral|Education regarding ambulation|The participants will be educated on the importance of postoperative ambulation during the recovery period.
16007271|NCT02833324|Behavioral|Ambulation reminder alarms|Participants in the intervention arm will receive 5 daily alarms to prompt them to ambulate. Alarms will be set to ring at 9am, 11am, 2pm, 5pm and 9pm. The Fitbit will be worn from the day of surgery (postoperative day 0) through postoperative day 9 or hospital discharge, whichever occurs first.
16007272|NCT02833324|Other|Fitbit|Participants who are postoperative for colorectal surgery, who have been cleared to ambulate during recover, will be equipped with an off-the-shelf Fitbit device (a wireless activity tracking device) which will record steps taken while the participant is hospitalized. The Fitbit will be worn from the day of surgery (postoperative day 0) through postoperative day 9 or hospital discharge, whichever occurs first.
16007273|NCT02833311|Behavioral|Computer Tablet Group|Participants will first meet once with a trained health education specialist. During this meeting the health education specialist will work with the participant in setting constructive and manageable goals and how to achieve them safely. Participants will then receive weekly follow-up phone calls to discuss progression and/or possible trouble-shooting strategies. Participants will be asked to set goals related to increasing self managing health behaviors. Participants will be encouraged to self-monitor goals, behaviors and symptoms using a computer tablet.
16007274|NCT02833311|Behavioral|Paper and Pencil Group|Participants will first meet once with a trained health education specialist. During this meeting the health education specialist will work with the participant in setting constructive and manageable goals and how to achieve them safely. Participants will then receive weekly follow-up phone calls to discuss progression and/or possible trouble-shooting strategies. Participants will be asked to set goals related to increasing self managing health behaviors. Participants will be encouraged to self-monitor goals, behaviors and symptoms using a paper-pencil diary.
16007275|NCT02833311|Behavioral|Standard Treatment Control Group|Participants will first meet once with a health education specialist. During this meeting the health education specialist will provide general information about engaging in healthy behaviors. Information will primarily focus on the benefits of engaging in healthy behaviors and safety precautions. Participants will then receive weekly follow-up phone calls to discuss various health topics.
16007276|NCT02833298|Behavioral|Automated reminders|At the time consent is obtained, members of the research team will collect data about how a subject prefers to be contacted for automated reminders (i.e. text messages, postcard, email, MyChart)
16007277|NCT02833298|Behavioral|Patient navigation|The patient navigator will attempt to provide a reminder to the subject one to three days before the scheduled imaging and also offer to accompany the subject to the test.
16007278|NCT02833272|Behavioral|EMPOWER Educational Brochure|The EMPOWER educational brochure explains the risk of benzodiazepine and non-benzodiazepine sedative use to patients with a current prescription. The brochure also provides a tapering schedule if the patient chooses to discontinue taking the drug.
16007279|NCT02833246|Other|SMS/MMS text messaging|text messaging reminders on oral chemotherapy medication adherence
16007280|NCT02833246|Other|usual care|
16007281|NCT02833233|Procedure|Cryoablation|
16007282|NCT02833233|Drug|Ipilimumab|
16007283|NCT02833233|Drug|Nivolumab|
16007284|NCT02833220|Device|Single-Pulse Transcranial Magnetic Stimulation|Single-pulse Transcranial Magnetic Stimulation activates neurons within the cortex of the brain by way of electromagnetic induction. This causes a small, focused electric field to become present in the brain, which activates the neurons.
16007455|NCT02831907|Procedure|Cardiac surgery|All cardiac surgery procedures with the use of cardiopulmonary bypass
16007285|NCT02833207|Drug|Drug Trial 1 (EDD)|"Drugs that increase blood flow and test EDD are: ACh, ISO, BK, ATP. Remaining drugs used to test mechanisms of EDD: L-NMMA, ketorolac, and BaCl2.
~Details under study description."
16007286|NCT02833207|Drug|Drug Trial 2 (ROV)|"Tools used to increase blood flow: muscle contractions and ATP. Remaining drugs used to test mechanisms of ROV: L-NMMA, ketorolac, and BaCl2.
~Details under study description."
16007287|NCT02833181|Device|BIS monitor|Monitoring circadian variation of EEG
16007288|NCT02833168|Other|patient-filled questionnaires|All patients answer selected questionnaires on sleep-related symptoms, sleep quality, daytime performance, and health-related quality of life.
16007289|NCT02833168|Device|spiromanometry|Measurement of forced vital capacity, maximum inspiratory pressure and maximum expiratory pressure
16007290|NCT02833155|Drug|Entinostat|Given PO
16007291|NCT02833155|Drug|Exemestane|Given PO
16007292|NCT02833142|Drug|BIIB033 (opicinumab)|
16007293|NCT02833116|Drug|Betamethasone|
16007294|NCT02833116|Drug|Dexamethasone|
16007295|NCT02833103|Drug|Danshu Capsules|Danshu Capsules (0.9g potid/day) for three months by oral
16007296|NCT02833103|Drug|Pinaverium Bromide|Pinaverium Bromide (100mg potid/day) for three months by oral
16007297|NCT02833090|Procedure|biomarkers|transthoracic echocardiography, radial, and aortic arterial blood sampling
16007298|NCT02833077|Device|JUVÉDERM VOLUMA® XC|JUVÉDERM VOLUMA® XC was injected into the chin at a volume determined by the investigator. The maximum total volume administered was up to 4 mL.
16007299|NCT02833064|Radiation|Non-contrast magnetic resonance imaging|
16007300|NCT02833064|Other|Biological sampling|Blood, urine, stool and breath sampling and analysis
16007301|NCT02833038|Drug|Magnesium Sulfate|adminstration of intravenous magnesium as bolus of 50 mg/kg, followed by continuous infusion at rate of 10 mg/kg/h
16007302|NCT02833038|Drug|Normal saline|the same bolus and infusion volumes of normal saline
16007303|NCT02833025|Device|Thrombin generation and Platelet Function Testing|Point-of-care testing of thrombin generation, platelet function, and rotational thromboelastometry
16007304|NCT02833012|Drug|Caprylic Triglyceride Oil|10 g Caprylic Triglyceride Oil (10.5 mL) at Hour 0 on Day 1
16007305|NCT02833012|Drug|AC-1202|60 g AC-1202 (shaken in 180 mL of water) at Hour 0 on Day 1
16007306|NCT02833012|Drug|Axona|40 g Axona (shaken in 120 mL of water) at Hour 0 on Day 1
16007307|NCT02833012|Drug|AC-1204|40 g AC-1204 (shaken in 120 mL of water) at Hour 0 on Day 1
16007308|NCT02832999|Drug|sub cutaneous liraglutide|Liraglutide 1.2mg/day
16007309|NCT02832999|Drug|Oral Vildagliptin|Vildagliptin 50mg/day
16007310|NCT02832986|Other|Medical Questionary|"The medical questionary will contain :
~Date of initial infection by Herpes zoster
~Localisation
~Severity
~Presence of postherpetic pain
~Postherpetic pain Intensity
~Postherpetic pain duration
~Antiviral treatment
~History of chronic pathologies
~Concomitant treatment"
16007311|NCT02832973|Drug|Spironolactone|Spironolactone 25 mg
16007312|NCT02832973|Drug|Furosemide,|Furosemide 20-40 mg
16007313|NCT02832973|Drug|Amiloride|Amiloride 5 mg
16007314|NCT02832973|Drug|Ramipril|Ramipril 5-10 mg
16007315|NCT02832973|Drug|Bisoprolol|Bisoprolol 5-10 mg
16007316|NCT02832960|Drug|Levothyroxine|The intervention will start with Levothyroxine 50 mcg daily (reduced to 25 mcg in subjects <50 kg of body weight or if known coronary heart disease - previous myocardial infarction or symptoms of angina pectoris) vs. matching placebo; at 3 months, if the serum TSH level is <0.4 mU/L, dose will be reduced by 25 mcg; TSH >=0.4 and <4.6 mU/L, no change to dose; TSH >=4.6 mU/L, additional 25 mcg. The process will be repeated at 12 months, then annually; mock titration will be performed in the placebo group. The maximum possible dose of Levothyroxine which will be prescribed is 150 mcg (after 4 increments of 25 mcg at 3 months, 1, 2, 3 years; from the starting dose of 50 mcg).
16007317|NCT02832960|Drug|Placebo|Control patients will obtain a placebo pill of the same characteristics as the intervention drug, and mock titration will be carried out identically to the intervention drug. Pharmaceutical composition of placebo (100 mg): Lactose monohydrate 66 mg, Maize starch 25 mg, Gelatin 5 mg, Croscarmellose sodium 3.5 mg, Magnesium stearate (vegetable source) 0.5 mg.
16007318|NCT02832947|Drug|Rivaroxaban 10 mg|At study month 7 (+/-1 month), patients receive at 8 a.m. a single dose of 10 mg rivaroxaban. Study specific blood tubes are sampled the same day at the indicated time points from T -1h to T 12h.
16007319|NCT02832934|Drug|Levothyroxine|The intervention will start with Levothyroxine 50 mcg daily (reduced to 25 mcg in subjects <50 kg of body weight or if known coronary heart disease - previous myocardial infarction or symptoms of angina pectoris) vs. matching placebo; at 3 months, if the serum TSH level is <0.4 mU/L, dose will be reduced by 25 mcg; TSH >=0.4 and <4.6 mU/L, no change to dose; TSH >=4.6 mU/L, additional 25 mcg. The process will be repeated at 12 months, then annually; mock titration will be performed in the placebo group. The maximum possible dose of Levothyroxine which will be prescribed is 150 mcg (after 4 increments of 25 mcg at 3 months, 1, 2, 3 years; from the starting dose of 50 mcg).
16007320|NCT02832934|Drug|Placebo|Control patients will obtain a placebo pill of the same characteristics as the intervention drug, and mock titration will be carried out identically to the intervention drug. Pharmaceutical composition of placebo (100 mg): Lactose monohydrate 66 mg, Maize starch 25 mg, Gelatin 5 mg, Croscarmellose sodium 3.5 mg, Magnesium stearate (vegetable source) 0.5 mg.
16007321|NCT02832921|Behavioral|cognitive training by virtual reality|
16007322|NCT02832921|Behavioral|watching a scientific TV documentary|
16007323|NCT02832921|Device|treadmill|"VR cognitive training will be augmented by walking on a treadmill, since it is well established that dual tasking-i.e. performing the VR-based cognitive effort together with a motor task, even as simple as walking on a treadmill-places greater demand on cognitive resources than a single task."
16007324|NCT02832908|Other|Change from semi-seated position to supine|from semi-seated position (30°) to lying position
16007325|NCT02832895|Other|Transcranial doppler examination|Assessment of frontal bone window for transcranial doppler
16007326|NCT02832882|Procedure|No-touch RFA|No-touch RFA indicates RFA without tumor puncture. In this study, no-touch RFA is performed using Octopus electrodes.
16007327|NCT02832882|Procedure|Conventional tumor puncture RFA|Conventional tumor puncture RFA indicates routine procedure of RFA in our institution. In this study, RFA procedure is performed using Octopus electrodes.
16071156|NCT02374567|Drug|Mianserin|
16007328|NCT02832869|Other|short message service based re-education|The patients will receive standard written instructions on preparing for a colonoscopy plus intervention such as short message system based re-education by one investigator on the day before colonoscopy.
16007329|NCT02832869|Other|Wechat based re-education|The patients will receive standard written instructions on preparing for a colonoscopy plus intervention such as Wechat based re-education by one investigator on the day before colonoscopy.
16007330|NCT02832856|Behavioral|Healthy Relationship Education|RS+ is a widely-implemented healthy relationship education curriculum that aligns with the Georgia Department of Education performance standards in health education. The full curriculum features 12 lessons covering such topics as healthy relationships, dating violence prevention, communication skills, conflict management, and decision making.
16007331|NCT02832856|Behavioral|Job Readiness Curriculum|"Beginning to Work it Out (BWIO) assists youth who are preparing for first-time employment. Topics include recognizing how personal beliefs and behaviors may be perceived in the workplace, as well as soft skills such as emotional self-management and problem-solving skills."
16007332|NCT02832830|Radiation|IMRT|Intensity modulated Raiotherapy (IMRT) of the involved spinal bone metastasis
16007333|NCT02832830|Radiation|fractionated RT|external beam Radiotherapy of the involved spinal bone metastasis
16007334|NCT02832817|Device|Pulse oximeter|For each monitoring of Arterial Oxygen Saturation, measures of Arterial Pulsed Oxygen Saturation will be made for each pulse oximeter.
16007335|NCT02832804|Device|transcranial Direct Current Stimulation|Experimental: anodal stimulation (2mA) for 20 minutes Active Comparator: cathodal stimulation (2mA) for 20 minutes Sham Comparator: sham stimulation (2mA) for 15 seconds
16007336|NCT02832791|Procedure|QUADRICEPS TENDON|Once the limb is prepped and draped,it is exsanguinated, and the tourniquet is raised to 250 mm Hg. We will make an arthroscopic examination through an anterolateral viewing portal to corroborate the ACL injury as well as the determination of possible associated lesions. The accessory medial portal is stablished slightly above the joint line (about 2 cm of the medial edge of the patel) that is used as an instrumentation portal. Then,, a high anteromedial portal, is made higher than the previous to see the femoral footprint. Once the associated meniscal or cartilaginous lesions are addressed attention turns to the harvesting of the graft. A 4 cm vertical incision is made starting at the proximal pole of the patella and directed proximally and centered in line with the quadriceps tendon. The subcutaneous tissue is dissected and a 70-80 mm long ,10 mm wide and 7mm depth graft is obtained with the use of a n21 scalpel 2cm of both limbs of the graft are sutured
16007337|NCT02832791|Procedure|HAMSTRING TENDON|"Once the limb is prepped and draped,it is exsanguinated, and the tourniquet is raised to 250 mm Hg. The procedure begins with an arthroscopic examination through an anterolateral viewing portal to corroborate the ACL injury as well as the determination of possible associated lesions. The accessory medial portal is stablished slightly above the joint line, at about 2 cm of the medial edge of the patellar tendon. This portal is used as an instrumentation portal. A third portal, a high anteromedial portal, is made higher than the previous, this portal will allow visualization of the femoral footprint.
~Once the associated meniscal or cartilaginous lesions are addressed attention turns to the harvesting of the graft.
~A 4cm oblique incision is made starting 2 cm medial to the tibial tubercle and directed proximally and medially. After dissecting the subcutaneous tissue the Sartorius fascia is incised and both tendons are identified and harvested with the use of a tendon stripper"
16007338|NCT02832778|Drug|Efavirenz|Efavirenz 400mg
16007339|NCT02832778|Drug|tenofovir /emtricitabine|tenofovir 245 mg/emtricitabine 200mg
16007340|NCT02832778|Drug|tenofovir/lamivudine|tenofovir 245mg/lamivudine 300mg
16007341|NCT02832778|Drug|lamivudine/zidovudine|lamivudine 300mg/zidovudine 600mg
16007342|NCT02832778|Drug|Rifinah or local generics|Rifampicin 600 mg and isoniazid 300 mg if ≥50kg or rifampicin 450 mg and isoniazid 300 mg if <50kg.)
16007343|NCT02832765|Radiation|A|Intensity modulated radiotherapy (IMRT) 30Gy in 10 fractions of the involved spinal bone metastases
16007344|NCT02832765|Radiation|B|Intensity modulated radiotherapy (IMRT) 30Gy in 10 fractions with an SIB with 40 Gy in 10 fractions to the metastasis of the involved spinal bone metastases
16007345|NCT02832765|Radiation|C|Intensity modulated radiotherapy (IMRT) 20Gy in 5 fractions of the involved spinal bone metastases
16007346|NCT02832765|Radiation|D|Intensity modulated radiotherapy (IMRT) 20Gy in 5 fractions with an SIB with 30 Gy in 5 fractions to the metastasis of the involved spinal bone metastases
16007347|NCT02832752|Procedure|ECPR Protocol|The regional protocol is activated for eligible patients who remain pulseless after 3 cycles of resuscitation, and intubation. The hospital team is activated at this time, which includes the emergency department team, a perfusionist, and a cardiovascular surgeon. A mechanical CPR device (Lucas chest compression device) is applied at this time and the patient is transported to hospital. The goal times from first professional CPR to ECMO flows is < 60 minutes, and from emergency department (ED) arrival to ECMO flows < 30 minutes.
16007348|NCT02832739|Device|SENACA - ICT based self-management support system|SENACA - ICT based self-management support system is a structured self-management support system with several interacting components, combining tele-monitoring devices and a solution for personalised health plans. ==> www.senaca.ch
16007349|NCT02832726|Dietary Supplement|Vitamin B12|
16007350|NCT02832713|Drug|Botulinum toxin A ( BoNT-A)|Intra-articular injection of BoNT-A
16007351|NCT02832713|Device|Hyaluronic acid (HA)|Intra-articular injection of Hyaluronic acid
16007352|NCT02832700|Dietary Supplement|Casein glycomacropeptide|
16007353|NCT02832700|Dietary Supplement|Placebo|
16007354|NCT02832687|Drug|Acetaminophen|patients 50kg or more receive1000mg in 100milliliters of normal saline every 4 hours to a maximum dose 4000mg/24 hours. <50kg receive 12.5mg/kg to a maximum of 75mg/kg/24 hours.
16007355|NCT02832687|Drug|normal saline|100mL of normal saline every 4 hours to a maximum administration of 400mL
16007393|NCT02832336|Drug|Vivarin|Adenosine is an endogenous sleep-promoting substance with neuronal inhibitory effects. Adenosine has been proposed to be a sleep-inducing substance accumulating in the brain during prolonged wakefulness. Caffeine is an adenosine receptor antagonist. It inhibits a part of the sleep cycle and, in turn, promotes the wakeup state. Caffeine results in the release of norepinephrine, dopamine and serotonin in the brain and the increase of circulating catecholamines, consistent with reversal of the inhibitory effect of adenosine.Vivarin Drug class :Central nervous system (CNS) stimulants.
16007394|NCT02832336|Drug|Fiber|Fiber will be used as placebo.
16007356|NCT02832674|Device|Percutaneous Radiofrequency single treatment|Percutaneous Radiofrequency single treatment' under controlled temperature conditions based on pre-defined amounts of energy as controlled by the device internal algorithm, and investigator expertise. Additionally, Hunsted solution will be infused in the treatment area to eliminate the electrode/fiber to touch inner layers of the skin. External temperatures (skin surface) will be monitored using a temperature reading camera to ensure the external temperature stays within acceptable levels during the procedure Ice packs will also be used as needed to cool the treatment area based on the Thermal Camera Reading where the . heat delivery may be exceeding the threshold.
16007357|NCT02832648|Dietary Supplement|selenase (selenium)|Selenase (Biosyn, Germany) Sodium selenite pentahydrate
16007358|NCT02832635|Drug|TMZ|TMZ 75mg/m2/d from the 1st day to the last day of radiotherapy
16007359|NCT02832635|Radiation|WBRT with avoidance of hippocampus|Whole brain radiotherapy of 30Gy/10f by IMRT (Intensity Modulation Radiated Therapy), with or without boost. The maximum dose of hippocampus should be no more than 18Gy.
16007360|NCT02832635|Radiation|WBRT without avoidance of hippocampus|Whole brain radiotherapy of 30Gy/10f by IMRT, with or without boost. The dose of hippocampus is not considered.
16007361|NCT02832622|Device|MPP|MPP ON within 1 month post implant and then continuously programmed ON until 12 months (i.e., MPP ON for months 1-12 continuously)
16007362|NCT02832622|Device|BiV/MPP|MPP ON at the 12-month study visit and for at least 3 continuous months prior to 12-month assessment (i.e., BiV pacing ON at some point in months 1-9 and MPP ON for months 10-12)
16007363|NCT02832609|Other|Supine|measurements after 30 minutes in complete supine position
16007364|NCT02832596|Drug|Norepinephrine|Ordinary anaesthesia and maintained preanesthetic blood pressure by norepinephrine infusion
16007365|NCT02832596|Procedure|Maintained blood pressure|Norepinephrine therapy to maintain preanesthesia blood pressure
16007366|NCT02832583|Device|Regenkit BCT-HA Cellular Matrix|To assess the efficacy of PRP-HA on skin rejuvenation, thirty one patients with chronological aging including wrinkles, dull and dry skin with loss of elasticity and firmness. The patients received three PRP-AH injection sessions 4 weeks apart into the cheeks.
16007367|NCT02832570|Drug|Sildenafil 100mg single oral dose|Measurement of maximal walking distance on a constant load treadmill test (3.12 km/ 10% slope)
16007368|NCT02832570|Drug|Placebo, Oral intake single dose|Measurement of maximal walking distance on a constant load treadmill test (3.12 km/ 10% slope)
16007369|NCT02832557|Other|Salivary collection|Collection of saliva via swab for miRNA processing
16007370|NCT02832557|Other|Vineland Adaptive Behavior Scale-III Assessment|
16007371|NCT02832557|Other|Medical history questionaire|
16007372|NCT02832557|Other|Autism Diagnostic Observation Schedule -2nd edition (ADOS-2)|
16007373|NCT02832557|Other|Mullen Scales of Early Learning|
16007374|NCT02832544|Drug|Rivaroxaban (20 mg)|Rivaroxaban is non-inferior to VKAs for the prevention of stroke or systemic embolism in patients with AF/flutter and RVHD and potentially superior to VKAs.
16007375|NCT02832544|Drug|Vitamin K antagonists (VKA)|
16007376|NCT02832531|Drug|Rivaroxaban (15 mg)|"Rivaroxaban is superior to aspirin for the prevention of the composite of stroke or systemic embolism in patients with RVHD with AF or flutter who are unsuitable for VKA therapy, or in patients with RVHD without AF or Flutter with at least one of the following:
~Left atrial enlargement ≥ 5.5 cm, OR
~Left atrial spontaneous echo contrast OR
~Left atrial thrombus OR
~Frequent ectopic atrial activity (>1000/24 hours) on Holter ECG."
16007377|NCT02832531|Drug|Aspirin|"Rivaroxaban is superior to aspirin for the prevention of the composite of stroke or systemic embolism in patients with RVHD with AF or flutter who are unsuitable for VKA therapy, or in patients with RVHD without AF or Flutter with at least one of the following:
~Left atrial enlargement ≥ 5.5 cm, OR
~Left atrial spontaneous echo contrast OR
~Left atrial thrombus OR
~Frequent ectopic atrial activity (>1000/24 hours) on Holter ECG."
16007378|NCT02832505|Other|No intervention but only observational|This study is a cross-sectional and observational MRI study with three cohorts of patients, and no interventions will be applied.
16007379|NCT02832492|Behavioral|pupil near response|
16007380|NCT02832466|Other|Functional Test|Observation of physical function in hemodialysis patients during a period of 6 months
16007381|NCT02832453|Behavioral|Lifestyle|The counselling program consists of 6 group meetings of 1 hour and 3 individual consultations of at least 15 minutes each. Sessions will be set up with the aim to enhance knowledge and empowerment related to physical activity, sedentary conducts, dietary habits, as well as strategies for behaviour change will be given. Individual consultations will focus on establishing realistic objectives and to involve the participants in taking decisions.
16007382|NCT02832453|Behavioral|Aerobic interval training|The supervised aerobic interval training will consist of 16 supervised group training lessons lasting 60 minutes and 32 individual nonsupervised training lessons that would be self-administered by each participant. The main part of the training lessons will consist of 4 series of 4 minutes of cycling at a heart rate of 80% of the VO2peak interspersed with active pauses of 2 minutes at 60% of the VO2peak .
16007383|NCT02832453|Behavioral|Traditional continous training|The supervised traditional continous training will consist of 16 supervised group training lessons lasting 60 minutes and 32 individual nonsupervised training lessons that would be self-administered by each participant. The main part of the training lessons will consist of activities such as walking, cycling, or tonification exercises always at an intensity of 60% of the VO2peak.
16007384|NCT02832440|Other|Exercise programmes|
16007385|NCT02832414|Behavioral|Intensive weight loss program|behavioral and dietary supplement
16007386|NCT02832401|Drug|Caffeine|
16007387|NCT02832401|Drug|Placebo|
16007388|NCT02832375|Drug|stannous fluoride|0.454% w/w stannous fluoride containing 1100ppm of fluoride
16007389|NCT02832375|Drug|sodium monofluorophosphate|0.76% w/w sodium monofluorophosphate containing 1000ppm fluoride
16007390|NCT02832362|Drug|Carbomer 980|Test product containing 0.5% carbomer 980 gel
16007391|NCT02832362|Other|Placebo|Reference product containing vehicle without 0.5% carbomer 980 gel
16007392|NCT02832349|Other|Educational Actions|Individual educational session and 3 group educational sessions (5-6 patients per group) built around the epileptic disease, its treatment and daily life, will constitute the program of EA group.
16007452|NCT02831933|Drug|nivolumab|Fully human immunoglobulin (Ig) G4 anti-PD-1 monoclonal antibody
16007395|NCT02832323|Biological|Reticera|A blood sample (before dialysis) under the usual conditions will be performed at D0 (= the day of Mircera® injection) 9 days (+/- 1 day) after each injection Mircera® for hemoglobin and reticulocytes dosage for a period of 6 months.
16007396|NCT02832310|Procedure|valsalva maneuver|the effects of valsalva maneuver on arterial pressure
16007397|NCT02832297|Other|Vectra DA|
16007398|NCT02832297|Other|Usual Care|
16007399|NCT02832284|Device|iNod System|The iNod System is intended for use for diagnostic ultrasound imaging and ultrasound-guided fine needle aspiration (FNA) of extramural and submucosal lesions of the tracheobronchial tree.
16007400|NCT02832271|Drug|SUNPHENON EGCg|SUNPHENON EGCg Oral, 400mg, twice per day
16007401|NCT02832271|Drug|Placebo|Placebo
16007402|NCT02832232|Other|translational dorsal glide mobilization technique grade III|"Translational dorsal glide mobilization technique grade III of the atlanto-occipital joint, it is a mobilization technique of Orthopedic Manual therapy according to Kaltenborn-Evjenth concept. The aim is to produce a dorsal glide of the occipital on the atlas, which will be held back by the therapist's hand, producing a stretch component of the suboccipital muscles.
~And Protocolized physiotherapeutic treatment: Three weeks of daily sessions (five a week) of stretching exercises, thermotherapy and postural education."
16007403|NCT02832232|Other|pressure maintained suboccipital Inhibition technique|"Pressure maintained suboccipital Inhibition technique is aimed to inhibit the tone of the suboccipital muscles. Although some dorsal occipital glide is produced by the weight of the head itself, the main effect is on the muscles due to dorsally pressure is not added to the occipital.
~And Protocolized physiotherapeutic treatment: Three weeks of daily sessions (five a week) of stretching exercises, thermotherapy and postural education."
16007404|NCT02832232|Other|Control Group|Protocolized physiotherapeutic treatment: Three weeks of daily sessions (five a week) of stretching exercises, thermotherapy and postural education.
16007405|NCT02832219|Dietary Supplement|Molecular hydrogen|
16007406|NCT02832219|Dietary Supplement|Placebo|
16007407|NCT02832206|Procedure|hybrid ablation|Surgical thoracoscopic epicardial ablation (box-lesion) and left atrial appendage occlusion , followed (after 2-3months) by electrophysiological examination, and catheter ablation (completion of the box-lesion, cavotricuspid isthmus ablation and other ablation if indicated)
16007408|NCT02832180|Drug|OC containing EE and NET|
16007409|NCT02832180|Drug|BMS-986142|
16007410|NCT02832167|Biological|Nivolumab|Specified dose on specified days
16007411|NCT02832154|Other|Internet-Based Intervention|Complete online PA program
16007412|NCT02832154|Procedure|Quality-of-Life Assessment|Ancillary studies
16007413|NCT02832154|Other|Questionnaire Administration|Ancillary studies
16007414|NCT02832141|Procedure|Mobilization anterior|Participant in prone position. Central thoracic mobilization from posterior-to-anterior.
16007415|NCT02832141|Procedure|Mobilization posterior|Participant in sitting position. Central thoracic mobilization from anteriors-to-posterior.
16007416|NCT02832128|Drug|AUT00063|4 capsules of 200 mg AUT00063, to take orally with food for 4 weeks
16007417|NCT02832128|Drug|Placebo|4 capsules of placebo, to take orally with food for 4 weeks
16007418|NCT02832115|Drug|Topical Nitroglycerine|Topical nitroglycerine is applied to wrist prior to transradial cardiac catheterization to dilate radial artery and reduce spasm in study arm patients
16007419|NCT02832115|Drug|Topical Lidocaine|Topical Lidocaine is applied to wrist prior to transradial cardiac catheterization in both study and control arms
16007420|NCT02832102|Procedure|Standard treatment of SCCHN patients|The interventions may include surgery, radiotherapy, chemotherapy or combined therapies, as recommended by best practice and international guidelines.
16007421|NCT02832089|Drug|oral carvedilol|oral carvedilol in escalating doses for reducing ventricular rate in AF patients
16007422|NCT02832076|Procedure|Subcutaneous negative suction drain for 10 days|
16007423|NCT02832076|Procedure|No subcutaneous drain|
16007424|NCT02832063|Biological|B244|4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.
16007425|NCT02832063|Biological|Placebo|4 pumps of spray to saturate the entire face applied BID. Applications should occur in the morning and at night for 12 weeks.
16007426|NCT02832050|Behavioral|Play therapy|See previous description of play therapy intervention arm.
16007427|NCT02832050|Behavioral|Standard of care|See previous description of comparator arm.
16007428|NCT02832037|Drug|BI 425809 dose 1|
16007429|NCT02832037|Drug|BI 425809 dose 2|
16007430|NCT02832037|Drug|BI 425809 dose 3|
16007431|NCT02832037|Drug|BI 425809 dose 4|
16007432|NCT02832037|Drug|Placebo|
16007433|NCT02832024|Device|plaque excision system|
16007434|NCT02832024|Device|stent|
16007435|NCT02832024|Device|Balloon|
16007436|NCT02832011|Dietary Supplement|olive oil|The infants fed with olive oil will have received same amount of calorie with infants who will receive eoprotin-fortified breast milk.
16007437|NCT02832011|Dietary Supplement|Eoprotin|Low birth weight infants are premature infants that born with birth weight less than 1500 g. Because these infants have low birth weight, weight gain can be increased by fortifying breast milk after post-natal 7 with eoprotin.
16007438|NCT02831998|Drug|ZuraPrep|Apply topically.
16007439|NCT02831998|Drug|ChloraPrep|Apply topically.
16007440|NCT02831998|Drug|ZP Vehicle|Apply topically.
16007441|NCT02831985|Procedure|general practice follow-up|Post-surgery follow-up by general practitioner
16007442|NCT02831985|Procedure|ear-nose-throat (ENT) specialist follow-up|Post-surgery follow-up by ear-nose-throat (ENT) specialist
16007443|NCT02831972|Drug|AG120|
16007444|NCT02831972|Drug|Itraconazole|
16007447|NCT02831946|Device|MODIFIED VICRYL PLUS|closing the intra-cuticular layer with MODIFIED VICRYL PLUS suture
16007448|NCT02831946|Device|DERMABOND GLUE|closing the intra-cuticular layer with Dermabond glue
16007449|NCT02831933|Biological|ADV/HSV-tk|Replication-defective recombinant adenovirus vector
16007450|NCT02831933|Drug|Valacyclovir|Prodrug of the antiviral drug acyclovir
16007451|NCT02831933|Radiation|SBRT|Low-dose SBRT
16007456|NCT02831894|Drug|0% Hypnotic Medication Taper|Participants will not have their soporific hypnotic medication dosage changed during a 20 week blinded tapering period
16007457|NCT02831894|Drug|25% Hypnotic Medication Taper|Participants will have their soporific hypnotic medication dosage reduced by 25% every two weeks during a 20 week blinded tapering period.
16007458|NCT02831894|Drug|10% Hypnotic Medication Taper|Participants will have their soporific hypnotic medication dosage reduced by 10% every two weeks during a 20 week blinded tapering period.
16007459|NCT02831868|Device|HAVAI|implantation of the HAVAI device to correct the IMA angle
16007460|NCT02831855|Drug|CP-690,550|"During the open-label run-in phase (Day 1 to Week 24), all subjects will receive one tablet open-label tofacitinib MR 11mg orally QD and open-label methotrexate capsule(s) orally every week at prior stabilized dose.
~During the double-blind phase, subjects who are randomized to the treatment arm will receive the same dosage of tofacitinib and methotrexate as describe above."
16007461|NCT02831855|Drug|Methotrexate|"During the open-label run-in phase (Day 1 to Week 24), all subjects will receive one tablet open-label tofacitinib MR 11mg orally QD and open-label methotrexate capsule(s) orally every week at prior stabilized dose.
~During the double-blind phase, subjects who are randomized to the treatment arm will receive the same dosage of tofacitinib and methotrexate as describe above."
16007462|NCT02831855|Drug|Placebo|During the double-blind phase, subjects who are randomized to the comparison arm will receive 11mg QD tofacitinib and the placebo capsules matching for methotrexate.
16007463|NCT02831842|Drug|Anti-EGFR-Containing Regimen|Study protocol does not specify any particular chemotherapy regimen. The data will be collected retrospectively.
16007464|NCT02831842|Drug|Bevacizumab-containing regimen|Study protocol does not specify any particular bevacizumab containing regimen. The data will be collected retrospectively.
16007465|NCT02831842|Drug|Chemotherapy|Study protocol does not specify any particular chemotherapy regimen. The data will be collected retrospectively.
16007466|NCT02831829|Other|water-based exercise training|Water-based training will be performed in upright position, in waist to xyphoid process deep thermo-neutral water at temperature of 32,8 C. The immersed exercise will include two session of aerobic and calisthenic exercise per day, six days of a week, both lasting 30 minutes
16007467|NCT02831829|Other|land-based exercise training|Land-based training will include two aerobic and calisthenic exercise session per day, six days of a week, both lasting 30 minutes
16007468|NCT02831816|Drug|ZuraPrep|Apply topically.
16007469|NCT02831816|Drug|ChloraPrep|Apply topically.
16007470|NCT02831816|Drug|ZP Vehicle|Apply topically.
16007471|NCT02831803|Dietary Supplement|Walnuts|28 gm/day in single-serve package
16007472|NCT02831803|Dietary Supplement|Extra Virgin Olive Oil|32 gm/day provided in 3, 34 ounce bottles
16007473|NCT02831790|Other|Fontan Education Videos|"The intervention will consist of three brief (~5 minute) professionally-developed whiteboard videos, available online. The videos will feature lay language at a grade 7 level or below and will be engaging. Topics are based on key findings of the Family Resilience Study, namely:
~Stress reactions in children and parents post Fontan. This video will be supplemented with existing resources on the topic.
~Anticoagulation
~Prolonged pleural drainage"
16007474|NCT02831777|Device|non-invasive blood pressure monitor|Equivalence of CareTaker blood pressure to classical sphygmomanometry
16007478|NCT02831751|Biological|30 µg/strain of Quadrivalent VLP Vaccine|Single dose of non-adjuvanted Quadrivalent VLP Vaccine
16007479|NCT02831751|Biological|60 µg/strain of Quadrivalent VLP Vaccine|Single dose of non-adjuvanted Quadrivalent VLP Vaccine
16007480|NCT02831751|Biological|FluLaval® Tetra (15 µg/strain)|Single dose of a licensed quadrivalent vaccine
16007481|NCT02831751|Biological|Fluzone® High-Dose (60 µg/strain)|Single dose of a licensed trivalent vaccine
16007482|NCT02831738|Dietary Supplement|Polydextrose|Polydextrose 12 g
16007483|NCT02831738|Dietary Supplement|Control Treatment|no polydextrose
16007484|NCT02831712|Dietary Supplement|Ferrous Fumarate|One tablet of a commercial iron supplement (Ferrous Fumarate 200 mg, from Drug House of Australia) will be provided to participants after overnight fast. The intervention is only one time.
16007485|NCT02831686|Drug|Selinexor|
16007486|NCT02831686|Drug|Ixazomib|
16007487|NCT02831686|Drug|Dexamethasone|
16007545|NCT02831283|Drug|18F-Florbetaben|18F-Florbetaben (Neuraceq) has FDA approval for human use in evaluation of Alzheimer's disease. 18F-Florbetaben will be administered at activity up to 8.1 mCi per injection.
16007546|NCT02831283|Procedure|Lumbar puncture (optional)|Subjects have the option to have lumbar puncture performed for the measurement of inflammatory markers in cerebrospinal fluid.
16007491|NCT02831660|Drug|idarucizumab|
16007492|NCT02831647|Dietary Supplement|AYMES PRAGUE|AYMES PRAGUE is a ready to drink, high energy, low volume oral nutritional supplement drink. It provides 300 kcal and 12g protein per 125ml serving. It is a Food for Special Medical Purposes (FSMP) and must therefore be used under medical supervision. It is not designed as a sole source of nutrition.
16007493|NCT02831634|Procedure|Blood sampling|After inclusion in the protocol, a blood sample (50 mL in EDTA tubes) will be withdrawn during pre-operative consultation.
16007494|NCT02831621|Behavioral|lifestyle intervention (diet OR diet+exercise)|diet or diet+fitness training
16007495|NCT02831608|Biological|Influenza vaccine|
16007496|NCT02831608|Biological|Placebo|
16007497|NCT02831595|Device|GKS Prime Flex Bioloy by Permedica, a TiNbN coated fixed-bearing cruciate-retaining total knee prosthesis|
16007498|NCT02831582|Dietary Supplement|Omega-3 Fatty Acid|Given PO.
16007499|NCT02831582|Other|Placebo|Given PO.
16007500|NCT02831569|Drug|Loxoprofen sodium|
16007501|NCT02831569|Drug|Methocarbamol|
16007502|NCT02831543|Drug|Motireb 5/100 mg|
16007503|NCT02831543|Drug|Mosapride citrate|
16007504|NCT02831543|Drug|Placebo|
16007505|NCT02831530|Drug|Abemaciclib|
16007506|NCT02831517|Drug|BIIB074|Administered as specified in the treatment arm
16007507|NCT02831517|Drug|Placebo|Matched Placebo
16007508|NCT02831491|Drug|Ramucirumab|Administered IV
16007509|NCT02831491|Drug|Docetaxel|Administered IV
16007510|NCT02831478|Drug|BAY987517|Applied liberally to the skin (Formulation: RB# Z16-071)
16007511|NCT02831478|Drug|Sunscreen Lotion (RB# T78-190B)|Applied liberally to the skin
16007512|NCT02831465|Behavioral|Healthy Subjects|Subjects with normal lung function performed MVV at increasing breathing frequencies and maximal tidal volume, from 10 to 100 cycles per minute. Inspiratory capacity (IC) was measured at rest and after each 12 seconds of MVV in order to detect DH. From the moment DH appeared at a given frequency, only one additional MVV at a higher breathing frequency was conducted to confirm DH.
16007513|NCT02831452|Other|pelvic floor muscle strength evaluation|
16007514|NCT02831439|Behavioral|Basic public reporting|The basic intervention will comprise public reporting through the WCHQ website. Individual-level, claims data submitted for billing to third party payers by participating healthsystems will be used to (i) identify cohorts of women with incident breast cancer at the practice-level and (ii) construct the metrics for public reporting and individual benchmarking information. These data are consistent with Medicare and Marketscan claims in both format and content thereby ensuring seamless application of the validated algorithm as well as construction of outcome variables as proposed in Aims 1 and 2 of the study.
16007515|NCT02831439|Behavioral|Enhanced intervention|The enhanced intervention adds an app comprising a decision tool, patient education and communication information that will be delivering concise, readily accessible information about the main components of the intervention. Specifically, physicians in participating practices will be provided a smartphone-based, point-of-care application that will include i) a list of the unproven/ineffective interventions with statements about a) scientifically proven appropriate use; b) proven or suspected downsides to inappropriate use; ii) clinical calculators that allow physician to input individual patients' clinical/tumor characteristics for each test; iii) practice-specific summary of publicly reported results; and iv) printable patient information adapted from the ASCO Choosing Wisely website.
16007516|NCT02831439|Behavioral|Control group - observational|"Comparison states will be used to evaluate the interventions in light of possible secular trends in the region and the nation. The design strategy will enable estimates of the effectiveness of the basic intervention (Aim 1) by comparing (i) the pre-intervention rates to post-intervention rates as well as by comparing (ii) changes between the pre- and post-intervention periods for the treatment state (WI) relative to comparison states, neighboring states and others. A similar approach will be used in Part II to provide estimates of the enhanced intervention's impact relative to the basic intervention and contemporary usual care provided in control states, thereby enabling the cost-savings analyses proposed as part of Aim 3."
16007547|NCT02831270|Procedure|Acute normovolemic hemodilution (ANH)|
16007548|NCT02831270|Drug|hydroxyethyl starch (HES 130/0.6)|
16007549|NCT02831257|Drug|AZD2014|
16007550|NCT02831244|Device|Agili-CTM|Consenting individuals will be selected from the population of patients with osteoarthritis of the great toe examined by a participating investigator. Following signing an informed consent, candidates will be evaluated by an adjudication committee for possible inclusion in the trial based on medical history and Standing Foot X-ray. Candidates that are approved or conditionally approved by the adjudication committee will undergo Agili-CTM implantation procedure
16007517|NCT02831426|Device|Two-stage with Acellular Dermal Matrix (CELLIS® Breast)|After mastectomy, an immediate reconstruction will be performed by means of a tissue expander, of any shape and type available, positioned in a subcutaneous, pre-pectoral, position. The tissue expander will be held in place by an ADM (CELLIS® Breast, MECCELLIS BIOTECH, 40 rue Chef de Baie, 17000, La Rochelle FRANCE) either completely wrapped around it or just covering its anterior surface. After at least 6 months a TE/implant exchange procedure will be performed with a synchronous fat grafting procedure to ameliorate the skin flap thickness and softness over the medial border and upper pole. Fat grafting will be performed with the wash and filter principle technique of handling the harvested fat tissue.
16007518|NCT02831426|Device|Two-stage with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra)|After mastectomy, an immediate reconstruction will be performed by means of a tissue expander, of any shape and type available, positioned in a subcutaneous, pre-pectoral, position. The tissue expander will be held in place by a Titanium Coated Polypropylene Mesh (TiLOOOP® Bra, pfm medical, ag Wankelstraße 60 ,50996 Köln GERMANY) either completely wrapped around it or just covering its anterior surface. After at least 6 months a TE/implant exchange procedure will be performed with a synchronous fat grafting procedure to ameliorate the skin flap thickness and softness over the medial border and upper pole. Fat grafting will be performed with the wash and filter principle technique of handling the harvested fat tissue.
16007519|NCT02831413|Behavioral|RS+|The curriculum's 12 sessions will be delivered over a period of about 12 weeks during the winter quarter, with an average of one session taught per week. The lessons cover topics such as personal values, the principals of smart relationships, communication and conflict management, and sexual decision making.
16007520|NCT02831413|Behavioral|Codeacademy|a computer programming curriculum, Codeacademy, that teaches students how to use HTML.
16007521|NCT02831400|Behavioral|Walking test|Walking test to increase cardiac output, maximum 12 minutes
16007522|NCT02831400|Behavioral|Standard Meal|After the walking test, volunteers eat a standard warm meal
16007523|NCT02831387|Drug|P-321 Ophthalmic Solution|P-321 Ophthalmic Solution 0.017%
16007524|NCT02831387|Drug|P-321 Ophthalmic Solution placebo|Placebo to match P-321 Ophthalmic Solution
16007525|NCT02831374|Drug|Local anesthesia|The surgical extraction under local anesthesia (2% Lignocaine and 1:100000 Adrenaline) procedure was the same in all patients.
16007526|NCT02831374|Procedure|surgical extraction of impacted third molar|After achieving Local anesthesia using 2% lignocaine hydrochloride with 1:100,000 epinephrine, standard Terrence Ward's incision was placed to raise a full thickness mucoperiosteal flap. Disto-buccal bone was carefully exposed and bone surrounding the buccal aspect of impacted tooth was performed using surgical bur under copious irrigation with 0.9% saline. Tooth was elevated using Coupland elevator and if required situations tooth was sectioned with surgical bur to facilitate its removal. The socket was checked for any tooth or bony debris. The bony margins smoothened using a file and irrigated with 0.9% saline.
16007527|NCT02831374|Biological|Preparation of PRP gel|Before surgery, 10 milliliter of venous blood was collected from the anticubital fossa of the patients forearm and stored into sterile tubes containing anticoagulant (0.5 milliliter citrate phosphate dextrose) from each patient in the experimental group using routine venipuncture procedure. The whole blood is then centrifuged at 1,200 rotations per minute for ten minutes. The supernatant layer obtained was platelet poor plasma and buffy coat was collected in a new sterile tube and centrifuged again at 1,000 rotations per minute for 10 min. The upper half of the supernatant is removed and the lower half is mixed carefully to get platelet rich plasma. Five drops of mixture of 10 % CaCl2 and 1000 Units bovine thrombin to 2 milliliter Platelet rich plasma to obtain the gel form.
16007528|NCT02831374|Procedure|Placing platelet Rich plasma and suturing|Subsequently, platelet rich plasma gel was placed into the extraction sockets of patients in the group A and wound closure was done using simple interrupted 3.0 black silk sutures.
16007529|NCT02831374|Procedure|Suturing|Wound closure was done using simple interrupted 3.0 black silk sutures.
16007530|NCT02831374|Drug|Postoperative medication|Patients were advised regular post extraction and prescribed 500 milligram of paracetemol postoperatively (1 tablet every 6 hours for 2 days).
16007531|NCT02831361|Drug|Gemigliptin|
16007532|NCT02831361|Drug|Gemigliptin placebo|
16007533|NCT02831361|Drug|Metformin|For patients who have been taking metformin, the patients who had taken at least 1000 mg of metformin daily and continue the same dosage and administration as before participant in the study
16007534|NCT02831361|Procedure|Diet/exercise questionnaire|"doing exercise with about intermediate intensity(50~70%) for ≥150minutes in total over at least 3 times(every other day) weekly should be recommended and regualr diet without greater changes in life style as much as possible during the whole study period.
~the questionnaire regarding diet/exercise will be collected at -week2, week 1 week 7, week 13, week 19, week 25"
16007535|NCT02831335|Other|MRI|Perform MRI studies
16007536|NCT02831335|Other|MRI|Perform MRI studies
16007537|NCT02831335|Other|MRI|Perform MRI studies
16007538|NCT02831335|Other|Group 4|Perform MRI studies
16007539|NCT02831322|Procedure|Percutaneous coronary intervention|Percutaneous coronary intervention was a nonsurgical technique for treating obstructive coronary artery disease
16007540|NCT02831309|Behavioral|Light-Intensity Condition|The light-intensity condition consisted of 8 hours of sitting interrupted with 2--minute, light--intensity activity breaks performed at 25% of heart rate reserve (HRR) every 18 minutes. Standardized meals were provided.
16007541|NCT02831309|Behavioral|Moderate-Intensity Condition|The moderate-intensity condition consisted of 8 hours of sitting interrupted with 2--minute, moderate-intensity activity breaks performed at 50% of heart rate reserve (HRR) every 18 minutes. Standardized meals were provided.
16007542|NCT02831309|Behavioral|High-Intensity Condition|The high-intensity condition consisted of 8 hours of sitting interrupted with 2--minute, vigorous-intensity activity breaks performed at 75% of heart rate reserve (HRR) every 18 minutes. Standardized meals were provided.
16007543|NCT02831309|Behavioral|Sedentary Condition|The sedentary condition consisted of 8 hours of sitting interrupted with 2-minutes of screen time every 18 minutes. Standardized meals were provided.
16007544|NCT02831283|Drug|11C-PBR28|11C-PBR28 is a PET radioligand that binds to the 18 kDa translocator protein (TSPO), a marker of inflammation. 11C-PBR28 has previously been administered in humans. 11C-PBR28 will be administered at activity of up to 20 mCi per injection.
16007551|NCT02831231|Drug|xanomeline tartrate|xanomeline tartrate, 75 mg capsule, TID
16007552|NCT02831231|Drug|Trospium chloride|trospium chloride, over encapsulated 20 mg tablet, BID
16007553|NCT02831218|Procedure|QCA and Aspirin|QCA(quantitative coronary angiography) guided BVS implantation and all patients are treated with dual antiplatelet therapy (aspirin 100mg/day and clopidogrel 75mg per day[or ticagrelor 90mg po bid]) for 12 months after BVS implantation, and randomized to either aspirin alone (aspirin 100mg/day) or clopidogrel alone (clopidogrel 75mg /day) for the next 4 years.
16007554|NCT02831218|Procedure|QCA and Clopidogrel|QCA(quantitative coronary angiography) guided BVS implantation and all patients are treated with dual antiplatelet therapy (aspirin 100mg/day and clopidogrel 75mg per day[or ticagrelor 90mg po bid]) for 12 months after BVS implantation, and randomized to either aspirin alone (aspirin 100mg/day) or clopidogrel alone (clopidogrel 75mg /day) for the next 4 years.
16007555|NCT02831218|Procedure|Imaging guided and Aspirin|BVS size and length were selected by on-line IVUS(intravascular ultrasound) or OCT(optical coherence tomography) measurements and all patients are treated with dual antiplatelet therapy (aspirin 100mg/day and clopidogrel 75mg per day[or ticagrelor 90mg po bid]) for 12 months after BVS implantation, and randomized to either aspirin alone (aspirin 100mg/day) or clopidogrel alone (clopidogrel 75mg /day) for the next 4 years.
16007556|NCT02831218|Procedure|Imaging guided and Clopidogrel|BVS size and length were selected by on-line IVUS(intravascular ultrasound) or OCT(optical coherence tomography) measurements and all patients are treated with dual antiplatelet therapy (aspirin 100mg/day and clopidogrel 75mg per day[or ticagrelor 90mg po bid]) for 12 months after BVS implantation, and randomized to either aspirin alone (aspirin 100mg/day) or clopidogrel alone (clopidogrel 75mg /day) for the next 4 years.
16007557|NCT02831205|Device|everolimus-eluting bioresorbable vascular (Absorb) scaffold|
16007558|NCT02831205|Device|everolimus-eluting cobalt-chromium (Xience) stent|
16007559|NCT02831192|Biological|microtransplantation|HLA mismatched donor mobilized prepheral stem cell infusion
16007560|NCT02831179|Drug|Capecitabine|Given PO
16007561|NCT02831179|Drug|Temozolomide|Given PI
16007562|NCT02831179|Drug|Veliparib|given PO
16007563|NCT02831179|Other|Pharmacological Study|Correlative studies
16007564|NCT02831179|Other|Laboratory Biomarker Analysis|Correlative studies
16007565|NCT02831166|Procedure|Transradial primary percutaneous coronary intervention|Transradial coronary angiography will be performed by the Judkins technique using 6 French diameter sheaths and pre-molded catheters for selective catheterization of left and right coronary arteries. Primary percutaneous coronary intervention with stent deployment will be indicated when a culprit lesion is identified, with high probability of angiographic success, being ideally performed immediately after coronary angiography Procedures will be performed according to recommendations of current guidelines. To achieve hemostasis in the transradial approach, a radial compression device will be applied, to maintain patent antegrade flow.
16007566|NCT02831166|Procedure|Transfemoral primary percutaneous coronary intervention|Transfemoral coronary angiography will be performed by the Judkins technique using 6 French diameter sheaths and pre-molded catheters for selective catheterization of left and right coronary arteries. Primary percutaneous coronary intervention with stent deployment will be indicated when a culprit lesion is identified, with high probability of angiographic success, being ideally performed immediately after coronary angiography Procedures will be performed according to recommendations of current guidelines. A vascular closure device will be used to achieve hemostasis in the transfemoral approach, preceded by systematic performance of femoral angiography and maintaining absolute bed rest for 60 minutes.
16007567|NCT02831153|Procedure|coronary angiography|Coronary angiography will be performed by transfemoral or transradial approach in all patients. In order to evaluate each coronary artery, at least four views from the left and two views from the right system will be taken.
16007568|NCT02831140|Behavioral|Early exercises|"In postoperative phase:
~Early exercises: within the first hour ;setting a half bed position, deep breathing and coughing . In the second hour, curbing vagal malaise and performing relaxation movements. In the third hour, walking about 20 to 30 minutes."
16007569|NCT02831140|Behavioral|Removing urinary probe and all catheters.|In postoperative phase : Removing urinary probe and all catheters.
16007570|NCT02831140|Behavioral|Early alimentation|In postoperative phase :Early alimentation: in the first hour to the second hour .
16007571|NCT02831140|Behavioral|commun interventions|"In preoperative phase: stopping smoking at least 2 weeks, hospitalization and balanced alimentation one day before the surgery.
~In peroperative phase : no use of benzodiazepines in the anesthesia , selective intubation , maintaining vital parameters as normal and using a mini invasive surgical approach ( video thoracoscopy , video assisted thoracoscopy , thoracotomy with preservation of the posterior muscles of the chest wall
~, preservation of Serratus anterior and the front part of Latissimus Dorsi ).
~In postoperative phase : Immediate extubation ( less than 30 minutes from the surgery end) , peridural or paravertebral or intercostal block analgesia , no use of abusive antibiotic , all analgesic drugs are permitted if there are no contraindications and physiotherapy from the 6th hour."
16007572|NCT02831127|Other|short message service group|Each month after stent implantation, the investigator sent a text message by SMS to inform patients the necessity of regular stent removal/exchange and the disadvantage of delayed management, and to remind them the appropriate date to come back to the hospital for stent management. Patients were requested to respond by SMS and were encouraged to contact the investigator if they had any questions about stent management. Besides, patients received conventional reminder:After stent implantation, all patients received oral and written instructions about further management. If single or multiple plastic stents were inserted, patients were informed to come back to the hospital at 3 months for stent removal/exchange; if FCSEMS was inserted, they were informed to come back to the hospital at 6 months after ERCP.
16007573|NCT02831127|Other|conventional group|After stent implantation, all patients received oral and written instructions about further management. If single or multiple plastic stents were inserted, patients were informed to come back to the hospital at 3 months for stent removal/exchange; if FCSEMS was inserted, they were informed to come back to the hospital at 6 months after ERCP.
16007612|NCT02830880|Other|MRI, CT, or Bone Scan|Conventional imaging such as a MRI, CT, or bone scan will be performed to correlate imaging findings.
16007613|NCT02830854|Other|Molecular Hydrogen|
16007650|NCT02830529|Behavioral|DASH diet education|The diet education component included lecture on reading labels, low cost healthy meal preparation, and dietary consultation regarding personal strengths and self-identified areas of improvement.
16007574|NCT02831114|Other|Acupuncture|Acupuncture uses tiny needles to promote blood flow, nervous system signaling, and brings the body back into homeostasis which the state of optimum functioning. Treatment for taxane induced peripheral neuropathy will consist of traditional acupuncture and will use points located in the foot (SP 3, ST 41, LR 3, K 3, GB 41), knee (SP 9, ST 36, K 10, GB 34), and arm (LI 11). Participants will continue to take their conventional therapy. Each acupuncture treatment will take place at Oriental Medicine Associates with trained acupuncturist, William Hendry. Each session should last about 30 minutes.
16007575|NCT02831101|Drug|Sufentanil|To evaluate, in the elderly, the impact of a concomitant administration of sufentanil during a step-wise propofol induction of anaesthesia on the depth of sedation measured using BIS and clinical sedation score.
16007576|NCT02831101|Drug|Placebo|To evaluate presence or absence of strong opioid (sufentanil) on BIS values in the elderly during propofol induction until the loss of consciousness
16007577|NCT02831088|Drug|Neu2000KWL High-does group|1st infusion of 750mg in patients receiving endovascular therapy within 8 hours following ischemic stroke onset followed by 9 consecutive infusions of 500 mg at intervals of 12 hours
16007578|NCT02831088|Drug|Neu2000KWL Low-does group|1st infusion of 500mg in patients receiving endovascular therapy within 8 hours following ischemic stroke onset followed by 9 consecutive infusions of 250 mg at intervals of 12 hours
16007579|NCT02831088|Drug|Placebo|1st infusion of the same volume of saline in patients receiving endovascular therapy within 8 hours following ischemic stroke onset followed by 9 consecutive infusions of same volume of saline at intervals of 12 hours
16007580|NCT02831075|Biological|Adipose-derived stem cell|stem cell acquisition, processing and reinfection, to evaluate the efficacy of adipose-derived stem cell.
16007581|NCT02831075|Biological|saline|
16007582|NCT02831062|Other|low protein diet + ketosteril|Patients will follow a diet containing 0.6 g protein/kg per day, phosphorus 5-10 mg/kg/day, Ketosteril 1 capsule per 5 kg body weight/day divided over three doses (max 8 capsules per dose).
16007586|NCT02831036|Other|training program|subjects in the trial group will follow a training program which includes 3 times a week running on a treadmill.
16007587|NCT02831036|Other|VO2max test|each subject will perform 4 times VO2max test according to BRUCE protocol in order to evaluate his aerobic fitness.
16007588|NCT02831036|Other|spatial orientation test|each subject will undergo 4 spatial orientation tests during the trial (month between 2 tests), each test is composed of 5 following days in which the subject will wear virtual reality glasses (Oculus Rift DK2) and attempt to arrive different destinations in a virtual maze tasks (using xbox one controller). each day will be given 3 attempts, the duration of each attempt is 2 min.
16007589|NCT02831023|Drug|Sulphadoxine-pyrimethamine|Each Fansidar tablet is scored containing 500mg sulphadoxine and 25 mg pyrimethamine. Doses will be administered by weight.
16007590|NCT02831023|Drug|0.25 mg/kg primaquine|Primaquine will be administered in an aqueous solution according to weight-based dosing.
16007591|NCT02831023|Drug|Dihydroartemisinin-piperaquine|160mg/20mg or 320mg/40mg of dihydroartemisinin/piperaquine tablets will be used to administer weight-based doses.
16007592|NCT02831023|Drug|Methylene blue|Methylene blue will be given as minitablets in prepackaged sachets according to weight groups.
16007593|NCT02831023|Drug|Amodiaquine|Amodiaquine will be administered once daily for 3 days, following weight-based dosing of 150 mg tablets.
16007594|NCT02830997|Device|Stereotactic guidance system|
16007595|NCT02830984|Procedure|EST+LBD+ENBD|Nasobiliary drainage after endoscopic sphincterotomy plus large-balloon dilation in treating of large bile duct stones
16007596|NCT02830984|Procedure|EST+LBD|Without nasobiliary drainage after endoscopic sphincterotomy plus large-balloon dilation in treating of large bile duct stones
16007597|NCT02830971|Procedure|Doing Different ICU techniques and skills|
16007598|NCT02830958|Device|Kinesiotaping|The Kinesio Taping® Method is a definitive rehabilitative taping technique that is designed to facilitate the body's natural healing process while providing support and stability to muscles and joints without restricting the body's range of motion as well as providing extended soft tissue manipulation to prolong the benefits of manual therapy administered within the clinical setting. Latex-free and wearable for days at a time, Kinesio® Tex Tape is safe for populations ranging from pediatric to geriatric, and successfully treats a variety of orthopedic, neuromuscular, neurological and other medical conditions.
16007599|NCT02830958|Other|No intervention|No intervention. Uses of an ordinary tape
16007600|NCT02830945|Behavioral|Motivational Interviewing Intervention Arm|
16007601|NCT02830945|Other|Control Brochure Arm|
16007602|NCT02830932|Biological|VXA-RSV-f Tablets (high dose)|The drug product will be provided as small white enteric-coated tablets. Multiple tablets may be administered to delivered the high dose.
16007603|NCT02830932|Other|VXA Placebo Tablets|The placebo will be provided as small white enteric-coated tablets that are similar in size and number to the active drug product tablets.
16007604|NCT02830932|Biological|VXA-RSV-f Tablets (low dose)|The drug product will be provided as small white enteric-coated tablets. Multiple tablets may be administered to delivered the low dose
16007605|NCT02830919|Drug|Glucosamine and chondroitin sulfate combination (Eurofarma)|
16007606|NCT02830919|Drug|Glucosamine and chondroitin sulfate combination (Zodic)|
16007607|NCT02830906|Drug|ramosetron|intravenous ramosetron 0.3 mg before spinal anesthesia and intrathecal morphine
16007608|NCT02830906|Drug|Ondansetron|intravenous ondansetron 8 mg before spinal anesthesia and intrathecal morphine
16007609|NCT02830893|Device|LARA|Study participants will use LARA to propel themselves and to play computer games with the impaired upper extremity for 30 min/day in addition to standard of care rehabilitation therapy for 3 weeks or the duration of their stay.
16007610|NCT02830893|Behavioral|Standard|Study participants will receive no exposure to LARA, will use a standard wheelchair, and will be asked to perform a program of conventional arm exercises for 30 min/day, also in addition to standard of care rehabilitation therapy for 3 weeks or the duration of their stay.
16007611|NCT02830880|Drug|FACBC PET-CT|Anti-3-[18F]FACBC is an investigational positron emission tomography (PET) radiotracer being studied given intravenously prior to PET scan.
16071157|NCT02374567|Drug|Trazodone|
16007614|NCT02830841|Device|remote ischemic preconditioning(RIPC)|After anesthesia induction, donors or recipients will be treated with automated blood pressure cuffs on their upper arms to receive RIPC by cuff inflation (to 15mmHg above systolic pressure) for 5 minutes and left inflated for 5 minutes. The cuff will then be deflated to 0 mm Hg and left uninflated for 5 minutes. This cycle will be performed 3 times in total.
16007615|NCT02830841|Device|Sham RIPC|Only blood pressure cuff will be placed to the patient, but no inflation or deflation will be performed.
16007616|NCT02830828|Other|Investigation of precision pinch grip control|
16007617|NCT02830802|Other|Dr. Hauschka Med Mundspüllösung Salbei / cosmetics|"Supervised use over 6 weeks 1x/day additional to habitual oral hygiene protocol.
~For an application fill the closure cap with the mouthwash. Rinse the mouth vigorously for 30 seconds, for easier timekeeping use the hourglass. Then spit out the mouthwash, do not rinse."
16007618|NCT02830802|Other|Placebo|"Supervised use over 6 weeks 1x/day additional to habitual oral hygiene protocol.
~For an application fill the closure cap with the mouthwash."
16007619|NCT02830789|Dietary Supplement|Calcium Carbonate|
16007620|NCT02830789|Dietary Supplement|Calcium Citrate|
16007621|NCT02830789|Dietary Supplement|Placebo|Tablet manufactured to mimic a calcium carbonate tablet
16007622|NCT02830789|Procedure|Roux-en-Y gastric bypass|Roux-en-Y gastric bypass surgery at least 12 months before study inclusion
16007623|NCT02830776|Drug|bimatoprost 0.03% ophthalmic solution|Latisse (bimatoprost 0.03% ophthalmic solution) applied to the eyelid margin for dermatochalasis (upper eyelid drooping)
16007624|NCT02830763|Dietary Supplement|CNT-02|Each subject will take 2.0g of the investigational product orally 3 times a day after every meal. Unless an apparent worsening of symptoms or unacceptable adverse event occurs, the subject will continue to take the investigational product for up to 6 months.
16007625|NCT02830750|Procedure|Ablation|
16007626|NCT02830737|Procedure|Traditional RFA|Radio frequency ablation via an ultrasound-guided electrode needle penetrating into the lesion center
16007627|NCT02830737|Procedure|No-touch RFA|Radio frequency ablation via an ultrasound-guided electrode needle penetrating into the tumor-free zone (within 5mm along the edge of the tumor)
16007628|NCT02830724|Drug|Cyclophosphamide|"For Phase I, Days -7 and -6:
~Dose Level 1: 15 mg/kg/day x 2 days IV Dose Level 2: 15 mg/kg/day x 2 days IV Dose Level 3: 15 mg/kg/day x 2 days IV Dose Level 4: 15 mg/kg/day x 2 days IV Dose Level 5: 30 mg/kg/day x 2 days IV Dose Level 6: 60 mg/kg/day x 2 days IV
~For Phase II, Days -7 and -6:
~60 mg/kg/day x 2 days IV"
16007629|NCT02830724|Drug|Fludarabine|"For Phase I, Days -7 to -5:
~Dose Level 1: 25 mg/m(2)/day x 3 days IVPB Dose Level 2: 25 mg/m(2)/day x 3 days IVPB Dose Level 3: 25 mg/m(2)/day x 3 days IVPB Dose Level 4: 25 mg/m(2)/day x 3 days IVPB Dose Level 5: 25 mg/m(2)/day x 5 days IVPB Dose Level 6: 25 mg/m(2)/day x 5 days IVPB
~For Phase II, Days -7 to -3:
~25 mg/m(2)/day x 5 days IVPB"
16007630|NCT02830724|Drug|Aldesleukin|Aldeskeukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every eight hours beginning within 24 hours of cell infusion and continuing for up to 3 days (maximum 9 doses).
16007631|NCT02830724|Biological|Anti-hCD70 CAR transduced PBL|Day 0: Cells will be infused intravenously on the Patient Care Unit over 20-30 minutes (2-5 days after the last dose of fludarabine).
16007632|NCT02830711|Other|Positive and Negative Affect Scale for Children|A 36-item instrument, including the Mood and Anxiety Symptom Questionnaire (MASQ)16 developed by Chang and Yeh and the Positive and Negative Affect Scale for Children developed by Watson and Clark
16007633|NCT02830685|Device|DTI with Acellular Dermal Matrix (CELLIS® Breast)|After conservative mastectomy, a pre-pectoral subcutaneous reconstruction with definitive implant will be performed using an ADM (CELLIS® Breast), either completely covering the implant or simply covering the anterior surface of it. The implant could be of any shape, material and texture available with no restriction. After at least 6 months, a fat grafting procedure, using a wash and filter principle for fat handling, will be performed over the implant.
16007634|NCT02830685|Device|DTI with Titanium Coated Polypropylene Mesh (TiLOOOP® Bra)|After conservative mastectomy, a pre-pectoral subcutaneous reconstruction with definitive implant will be performed using a TCPM (TiLOOOP® Bra), either completely covering the implant or simply covering the anterior surface of it.The implant could be of any shape, material and texture available with no restriction. After at least 6 months, a fat grafting procedure, using a wash and filter principle for fat handling, will be performed over the implant.
16007635|NCT02830672|Procedure|Surgical release A1 pulley for Trigger finger of the hand|
16007636|NCT02830646|Other|DFG mesure|Measure the effect of gastric bypass on the report DFG / VEC.
16007637|NCT02830633|Procedure|LNTME|Patients in this group received laparoscopy-assisted nerve-preserved TME for treatment of rectal cancer
16007638|NCT02830633|Procedure|OTME|Patients in this group received traditional open TME for treatment of rectal cancer
16007639|NCT02830620|Other|Dosage of chimiokines|
16007640|NCT02830607|Device|Xiaomi Mi Band|participants will wear Xiaomi Mi Band as assessment tool for recovery after epidural steroid injection for treatment of low back pain
16007641|NCT02830594|Radiation|External Beam Radiation Therapy|Undergo palliative external beam radiation therapy
16007642|NCT02830594|Other|Laboratory Biomarker Analysis|Correlative studies
16007643|NCT02830594|Biological|Pembrolizumab|Given IV
16007644|NCT02830568|Procedure|open donor nephrectomy|open donor nephrectomy
16007645|NCT02830568|Procedure|standard and hand-assisted laparoscopic donor nephrectomy|standard and hand-assisted laparoscopic donor nephrectomy
16007646|NCT02830568|Procedure|laparoscopic robotic-assisted nephrectomy|laparoscopic robotic-assisted nephrectomy
16007647|NCT02830542|Drug|SER-262|SER-262 is a rationally designed, multi-strain Ecobiotic® microbiome therapeutic produced synthetically by in vitro fermentation. It is a consortium of anaerobic, commensal bacteria in spore form, encapsulated for oral administration.
16007648|NCT02830542|Drug|Placebo|Placebo will be identical to the investigational product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline.
16007649|NCT02830529|Behavioral|MAD DASH|Participants were taught mindfulness meditation including body scan, loving kindness meditation and breathing exercises. The diet education component included lecture on reading labels, low cost healthy meal preparation, and dietary consultation regarding personal strengths and self-identified areas of improvement.
16007651|NCT02830516|Other|Measurement of lung elastance by two methods|Measurement of tidal variations in esophageal pressure followed in the same patient by performing a PEEP-step while simultaneously measuring the change in lung volume
16007652|NCT02830503|Procedure|Feeding tube daily replacement|Feeding tubes replaced once a day in the first week of life.
16007653|NCT02830490|Other|functional tests|Test-retest reliability of physical function in hemodialysis patients
16007654|NCT02830477|Biological|Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973|unmodified, full length recombinant FVIII
16007655|NCT02830438|Device|Shear wave elastography|Ultrasound technique of the kidneys to assess wave elastography.
16007656|NCT02830425|Other|No intervention|
16007657|NCT02830412|Other|Postoperative nausea and vomiting (PONV) reminder|The postoperative nausea and vomiting (PONV) electronic reminder will be programmed to assess the patient risk for PONV according to the risk factors identified by Apfel and Koivuranta. The PONV risk assessment and current guidelines will be displayed electronically for patients randomized to receive the reminder.
16007658|NCT02830399|Device|active rTMS-ECT|5 High Frequency (20Hz) rTMS (applicated on the left prefrontal dorsolateral cortex) before 5 bilateral ECT
16007659|NCT02830399|Device|sham rTMS-ECT|5 sham rTMS (applicated on the left prefrontal dorsolateral cortex) before 5 bilateral ECT
16007660|NCT02830386|Device|LVIS stent|Patients who meet the inclusion criteria will be treated with a low profile visualized intraluminal support (LVIS) stent with coils.
16007661|NCT02830373|Device|LVIS stents|Patients who meet the inclusion criteria will be treated with a low profile visualized intraluminal support (LVIS) stent with coils.
16007662|NCT02830360|Drug|Antiarrythmic Drug Therapy|Patients will be prescribed antiarrhythmic drugs (either amiodarone or sotalol based on specific clinical presentation, including medical history, functional class, ejection fraction, and renal function.)
16007663|NCT02830360|Procedure|Catheter ablation|Intracardiac electrode catheters are placed via central vasculature to identify myocardial scar, and surviving conduction channels within the scar which form the substrate for ventricular tachycardia. Radiofrequency energy is applied to these sites, interrupting the VT circuits.
16007664|NCT02830347|Drug|Amoxicillin|Extraction
16007665|NCT02830347|Procedure|Extraction|Extraction of third molars
16007666|NCT02830321|Other|helicopacter pylori stool antigen test (CER TEST BIOTEC)|Stool samples were tested by using one step H.pylori stool antigen test (CER TEST BIOTEC)for the detection of H. pylori antigen in pregnant women with hyperemesis gravidarum
16007667|NCT02830295|Other|Basic Body Awareness Therapy|Basic body awareness therapy is a health oriented and person-centred approach with focus on the patient's resources. This is a method in physiotherapy, where we search to promote movement quality in daily life through self-exploration and self-experience.BBAT conceives the person from the biomechanical, physiological, bio-psycho-social and existential aspects, using the movement quality as a witness of the link in between all these perspectives.It can be done individually or in groups, through different daily life movements: lying, sitting, standing, walking, pair movements, use of voice and massages. BBAT has validated and reliable assesment tools, as BARS and BAS-I
16007668|NCT02830282|Other|Blood Collection|
16007669|NCT02830269|Device|Transcranial Doppler ultrasonography measurements|Third ventricle diameter measurements with standard method (CT) and Transcranial Doppler ultrasonography
16007670|NCT02830256|Other|NCS-I (Nociception Coma Scale adapted intubated patients)|Every included patient will be assessed by the 3 methods 3 times (before, during, after the procedure fo care) in 3 conditions. There will be 2 painful conditions usually performed in ICU (Nursing and bronchoaspiration) and a painless condition (RASS assessment).
16007671|NCT02830243|Drug|Sevoflurane|End-tidal concentration of sevoflurane was maintained at age-corrected 1 minimum alveolar concentration throughout the study period. The remifentanil infusion rate was adjusted using TCI pump to achieve surgical pleth index between 20 and 50.
16007672|NCT02830243|Drug|Desflurane|End-tidal concentration of desflurane was maintained at age-corrected 1 minimum alveolar concentration throughout the study period. The remifentanil infusion rate was adjusted using TCI pump to achieve surgical pleth index between 20 and 50.
16007673|NCT02830230|Drug|Tab cefixime,Tab Azithromycin|The women with clinical cervicitis will receive treatment for cervicitis.
16007674|NCT02830204|Device|Mitral Valve Replacement with Sapien3|subjects with surgical MVR with Sapien3
16007675|NCT02830165|Other|Laboratory Biomarker Analysis|Correlative studies
16007676|NCT02830165|Other|Quality-of-Life Assessment|Ancillary studies
16007677|NCT02830165|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
16007678|NCT02830152|Device|LAAO|The left atrial appendage is occluded with the AMPLATZER™ Amulet™ device, which offers a conformable disc and lobe designed for complete occlusion of the left atrial appendage.
16007679|NCT02830152|Drug|Medical Therapy|Available options included in Medical therapy are: anticoagulation with OAC or NOAC, antiplatelet therapy (including monotherapy and dual antiplatelet therapy) and no pharmacological antithrombotic therapy.
16007680|NCT02830139|Procedure|Hyperthermic intraperitoneal chemotherapy (HIPEC)|Normal saline 3000ml-4000ml, Cisplatin 60mg/m2, 5-Fu 1500mg/m2, 43°C, 60min, During surgery and 7 days after surgery.
16007681|NCT02830139|Procedure|Radical colorectal resection|radical colorectal resection with lymphadenectomy
16007682|NCT02830139|Drug|Oxaliplatin , Capecitabine|XELOX postoperative chemotherapy Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14.
16007683|NCT02830139|Drug|Normal saline , Cisplatin , 5-Fu|
16007684|NCT02830126|Other|Anesthesiology Control Tower Feedback|Clinicians in the Anesthesiology Control Tower will provide extra support for the anesthesiology team in the operating room.
16007685|NCT02830113|Procedure|non-surgical periodontal treatment|One session of complete scaling, polishing, root planning, and the irrigation of periodontal pockets with a 10% povidone iodine solution
16007686|NCT02830100|Other|Healthy volunteers|Magnetic Resonance Imaging during intern speech, listening, talking, thinking.
16007687|NCT02830100|Device|MRI|
16007688|NCT02830087|Procedure|Tourniquet Cuff Pressure|Tourniquet cuff pressure is how hard the tourniquet cuff, which is placed around the patient's thigh, presses on the thigh in order to cut off blood supply to the lower leg during total knee surgery.
16007767|NCT02829424|Drug|Methotrexate|Use of low dose methotrexate (MTX) in psoriasis patients receiving an anti TNF alpha agent
16008032|NCT02827513|Drug|CTN XR3|
16007689|NCT02830074|Behavioral|Best practices PAP + patient Education +ongoing Support and Training|"This is a combined sleep and PAP adherence program, called the BEST program (Best practices PAP + Education + ongoing Support/Training"
16007690|NCT02830074|Behavioral|Sleep Education|This program includes non-directive sleep education plus standard treatment of SDB.
16007691|NCT02830061|Other|Interviews|Individual semi-structured interviews for 30-60 minutes using an interview schedule developed from an interpretative phenomenological analysis framework.
16007692|NCT02830048|Drug|Glibenclamide|
16007693|NCT02830035|Procedure|Real-time Ultrasound-guided|Real-time ultrasound guided paramedian spinal anesthesia
16007694|NCT02830035|Procedure|Anatomical Landmark Technique|Conventional anatomical landmark technique for paramedian spinal anesthesia
16007695|NCT02830022|Other|physiological explorations|
16007696|NCT02830009|Other|Urines samples|24-hour urines will be collected
16007697|NCT02830009|Other|Blood sample|
16007698|NCT02829996|Drug|trabodenoson 6.0% / latanoprost 0.005% QD|Trabodenoson 6.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.
16007699|NCT02829996|Drug|trabodenoson 3.0% / latanoprost 0.005% QD|Trabodenoson 3.0% / latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.
16007700|NCT02829996|Drug|trabodenoson 6.0% / latanoprost 0.0025% QD|Trabodenoson 6.0% / latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.
16007701|NCT02829996|Drug|latanoprost 0.005% QD|Latanoprost 0.005% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.
16007702|NCT02829996|Drug|latanoprost 0.0025% QD|Latanoprost 0.0025% administered once per day in both eyes and placebo administered once per day in both eyes, for 8 weeks.
16007703|NCT02829983|Drug|Clarithromycin|Use of 500mg of Clarithromycin twice a day for 3 days
16007704|NCT02829983|Drug|Placebo|Use of placebo tablets twice a day for 3 days.
16007705|NCT02829983|Other|One-stage full-mouth ultrasonic debridement (FMUD)|One session of Periodontal debridement using ultrasonic device.
16007706|NCT02829970|Behavioral|SUCCEEDS Program|Participants will receive ADHD Psychoeducation, Brief Motivational Interviewing (BMI) and Behavioral Activation for Attention & Alcohol Disorders (BAAAD).
16007707|NCT02829970|Behavioral|Living a Healthy College Lifestyle|Participants will receive ADHD Psychoeducation, BMI and Supportive Counseling (SC).
16007708|NCT02829957|Drug|Apixaban|10mg BID for 7 days, then 5mg BID for three months
16007709|NCT02829957|Drug|Rivaroxaban|15mg BID for 7 days, then 20mg daily for three months
16007710|NCT02829944|Drug|Ropivacaine|
16007711|NCT02829944|Drug|Ketorolac|
16007712|NCT02829944|Drug|Placebo|
16007713|NCT02829931|Radiation|Hypofractionated Stereotactic Irradiation|Hypofractionated Stereotactic Irradiation (HFSRT) prior to nivolumab.
16007714|NCT02829931|Drug|Nivolumab|Nivolumab intravenously (IV): 240 mg every (q) 3 weeks x 4 months followed by 480 mg X 4 months.
16007715|NCT02829931|Drug|Bevacizumab|Bevacizumab intervenously (IV): 15 mg/kg every (q) 3 weeks when given with Ipilumumab and Nivolumab combination. Dose changed to 10mg/kg every 2 weeks when given with Nivolumab only.
16007716|NCT02829931|Drug|Ipilimumab|Ipilimumab 1mg/kg intervenously (IV) 200 mg (5 mg/mL) every (q) 3 weeks for 4 months.
16007718|NCT02829892|Device|Light therapy|14-days exposure with an innovative ambient light
16007719|NCT02829879|Drug|8% arginine/1450ppm sodium monofluorophosphate dentifrice|
16007720|NCT02829879|Drug|5% potassium nitrate/2500ppm sodium fluoride dentifrice|
16007721|NCT02829866|Device|AMIStem-H|
16007722|NCT02829853|Genetic|Genetic analysis by SANGER and WHOLE EXOME NEXT GENERATION SEQUENCING|Patients with sarcoidosis patients are monitored in the regular follow-up in one of 28 GSF clinical centers. Blood sampling was performed in two 5ml classical heparinized tube, as used for red/white/platelets blood cells analysis. The patients receive complete information on the SARCFAM protocol and sign an informed consent stating that the genetic study will be conducted on the BTNL2 gene and genes related to immunity, including loci other than BTNL2.DNA was extracted from a 1-5 ml sample of blood and stored in frozen conditions until analysis. Genomic DNA is captured using Agilent in-solution enrichment methodology (Human Clinical Research Exome, Agilent) with their biotinylated oligonucleotides probes library, followed by paired-end 75 bases massively parallel sequencing on Illumina HiSEQ 400. For each genomic position, the exomic frequencies (Homo & HTZ) are determined from all the exomes already sequenced and/or the exome results provided by 1000G, EVS, HapMap database.
16007723|NCT02829840|Drug|Ponatinib|"Part 1: Ponatinib at starting dose of 30 mg by mouth every day for one 28 day cycle.
~Part 2 Phase I Dose Escalation: Ponatinib at starting dose of 30 mg by mouth every day of a 28 day cycle.
~Part 2 Phase II Dose Expansion: Ponatinib at maximum tolerated dose from Phase I by mouth every day of a 28 day cycle."
16007724|NCT02829840|Drug|5-azacytidine|"Part 2 Phase I Dose Escalation: 5-azacytidine at dose of 75 mg/m2/d administered subcutaneously (SQ) or intravenously (IV) for on Days 1-7 of every 28 day cycle.
~Part 2 Phase II Dose Expansion: 5-azacytidine 75 mg/m2/d administered subcutaneously (SQ) or intravenously (IV) on Days 1-7 of every 28 day cycle."
16007725|NCT02829840|Behavioral|Phone Calls|"About 30 days after end-of-study visit, study staff calls participant and asks if they have had any side effects and/or started any new treatment(s).
~If disease appears to be responding to study drugs, study staff calls participant every 3-6 months for up to 5 years and asks how they are doing and about any side effects they may be having."
16007726|NCT02829827|Drug|Radiprodil|Radiprodil at individualized doses.
16007727|NCT02829814|Drug|TNX-102 SL Tablet, 2.8 mg|Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.
16007728|NCT02829814|Drug|Placebo SL Tablet|Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.
16007766|NCT02829437|Other|Treatment for EST|Surgery and/or Chemotherapy and or/radiotherapy for EST treatment according to disease guidelines: no specific treatment is imposed by protocol (observational study)
16007729|NCT02829801|Behavioral|AAT and cognitive stimulation and rehabilitation of social tie.|"There are 8 workshops, one workshop per week. The workshops will begin with a 15 minute introductory activity allowing the establishment of the relationship with the dog and between the participants. Activities with the dog will be offered: games, caresses, brushing.
~Then, a 40 minute cognitive stimulation will be offered. Finally, 5 minutes will be devoted to the closing of the session and to say goodbye to participants and the dog (pet him, play with him ...)."
16007730|NCT02829801|Behavioral|Cognitive stimulation and rehabilitation of social tie.|"There are 8 workshops, one workshop per week. The workshops will begin with an introductory activity of 15 minutes that will establish the relationship between the participants. Different topics will be proposed to foster communication and exchange.
~Then, the same cognitive stimulation in the AAT arm will be offered."
16007731|NCT02829788|Other|Non interventional|Peroperative data collection
16007732|NCT02829775|Drug|Pegylated Interferon Alfa-2a|Participants will maintain the same dose they were receiving in the parent protocol.
16007733|NCT02829775|Drug|Recombinant Interferon Alfa 2a|Participants will maintain the same dose they were receiving in the parent protocol.
16007734|NCT02829762|Other|Program of geriatric and Social intervention associated techniques of Domotic and Remote assistance|Implementation of social aids, a monthly social monitoring and home improvement with domotic techniques and remote assistance
16007735|NCT02829749|Device|NeoChord beating heart mitral valve implantation|The NeoChord DS1000 procedure is performed in five steps: (1) Device Preparation; (2) Left Ventricular Access; (3) Leaflet Capture and Verification; (4) Suture Deployment and (5) Suture Closure. The sutures are placed via a ventriculotomy 2-4 cm postero-lateral from the apex of the left ventricle via thoracotomy. The procedure is performed on a beating heart through a 2 to 3 inch right antero-lateral thoracotomy, then one to five Goretex neochordae are introduced with a transcatheter delivery system through the apex of the heart, into the left ventricle, and fixed on the free edge of the prolapsed leaflet. This is performed with transesophageal echocardiographic guidance.
16007736|NCT02829749|Procedure|Control|traditional mitral valve repair performed under cardiac arrest
16007737|NCT02829736|Procedure|Intraoperative sealing test|A standard 28 Fr chest tube is inserted through the anterior port hole and all port holes are closed. With the tip of the chest tube below water, the pleura is emptied from air during continuous ventilation of the lungs. An air leak after 5 minutes of ventilation indicates a negative sealing test, whereas a cessation of air leak within 5 minutes indicates a positive sealing test.
16007738|NCT02829736|Procedure|Standard post-operative chest tube|A regular chest tube is left in the pleura.
16007739|NCT02829736|Procedure|Intraoperative chest tube removal|Chest tube is removed intraoperatively.
16007740|NCT02829723|Drug|BLZ945|
16007741|NCT02829723|Drug|PDR001|
16007742|NCT02829710|Behavioral|Nurse-driven sedation protocol|The nurse-driven sedation protocol included the COMFORT-B scale. Initial doses were chosen by the physicians then all changes were made by the nurses with the aim of attaining an optimal range of analgesia and sedation, which was defined as values from 11 to 17 on the COMFORT-B score.
16007743|NCT02829697|Drug|Ropivacaine|Perineural injection.
16007744|NCT02829684|Other|Data collection|This register will follow the evolution of the clinical practices and their consequences in the health of the patients, in all regions of France in order to have a national register. for Children and adults.
16007745|NCT02829671|Other|Clinical and biological assessment|Blood sample, clinical assessment with quetsionnaires
16007746|NCT02829658|Behavioral|Psychologic test|Assessment by a psychologist including the Structured Interview for Diagnostic and Statistical Manual (DSM)-IV Personality Disorders (SIDP-IV) was given straight to those who had a score above 28. This questionnaire allowed us to distinguish one group of subjects with BPD and a group with other PD (without BPD). Clinical evaluation included Axis I (MINI), Axis II (SIDP-IV), psychopathological features (YSQ-I, Defense Style Questionnaire (DSQ-40), demographic variables and therapeutic alliance (Haq-II).
16007747|NCT02829658|Other|No intervention|No intervention
16007748|NCT02829645|Other|Clinical assessment|Clinical assessment with questionnaires
16007749|NCT02829632|Behavioral|Group Sessions|Participants will receive a 3-session behavioral lifestyle program for a healthful lifestyle and weight loss.
16007750|NCT02829632|Behavioral|Feedback|Participants will receive up to 4 daily feedback messages based on progress in attaining target behavior. The feedback messages will be delivered on a variable ratio schedule and tailored to data in subjects' dietary recordings.
16007751|NCT02829632|Behavioral|Self-monitoring|Participants will receive an one-time how to self-monitor using the smartphone session.
16007752|NCT02829606|Other|small scotoma using Head Mounted Display No re-mapping|re-mapping software turned off
16007753|NCT02829606|Other|Large scotoma using Head Mounted Display PLUS re-mapping|re-mapping software turned on
16007754|NCT02829593|Other|hypoglycemia (low blood sugar) and MRI|hypoglycemia (low blood sugar) and MRI
16007755|NCT02829580|Procedure|Echocardiography|Measures by Doppler and study of endothelial function
16007756|NCT02829567|Behavioral|Motivational interviewing|
16007757|NCT02829541|Drug|BIIB068|Administered as specified in the treatment arm.
16007758|NCT02829541|Drug|Placebo|Administered as specified in the treatment arm
16007759|NCT02829528|Behavioral|Little Flower Yoga For Kids|Little Flower Yoga for Kids is a promising yoga and mindfulness program for children developed by Jennifer Cohen Harper, MA, E-RCYT, which incorporates five elements (connect, breathe, move, focus, relax) to improve the child's ability to sustain attention and regulate emotions.
16007760|NCT02829515|Procedure|tonsil surgery with or without concomitant adenoidectomy|tonsillectomy, tonsillectomy with adenoidectomy, tonsillotomy, tonsillectomy with adenoidectomy
16007761|NCT02829502|Drug|Byetta|Single dose of subcutaneous injection of 5 μg exenatide (Byetta).
16007762|NCT02829502|Drug|Normosaline|Single dose of subcutaneous injection of 20 μL normosaline (placebo).
16007763|NCT02829476|Biological|Osteoblast sample|culture osteoblasts obtained from vertebrae fragments from 30 patients with AIS and from 10 control patients with secondary scoliosis
16007764|NCT02829463|Radiation|Magnetic resonance imaging|3.0 T Magnetic resonance imaging of knee joints. It does not harm the subjects.
16007765|NCT02829450|Other|peritoneal ultrafiltration|Peritoneal fluids should be inserted intraperitoneally for several hours dwell
16008224|NCT02826005|Device|MRI|
16007768|NCT02829424|Drug|Methotrexate Placebo|Use of placebo- MTX in psoriasis patients receiving anti TNF alpha agent according to the approved indication
16007769|NCT02829411|Behavioral|Workforce Readiness Program|job readiness workshops, organized into ten daily sessions over two weeks.
16007770|NCT02829411|Behavioral|Relationship education|"25-hours of Within My Reach curriculum and relationship skills education sessions"
16007771|NCT02829398|Procedure|CerebroSpinal fluid and plasma samples|CerebroSpinal fluid and plasma samples for biological markers
16007772|NCT02829385|Drug|Apatinib and XELOX combined treatment group|"Apatinib Mesylate Tablets 500 mg P.O.d1-21 and XELOX (oxaliplatin 130mg/㎡ i.v. d1, capecitabine 1000mg P.O. d1-d14)
~Every 3-week time is a cycle until PD or intolerance of drug toxicity occurs."
16007773|NCT02829372|Drug|CD3/HER2 bispecific monoclonal antibody|Increasing doses, IV on day 1 and 15 of each 28 day cycle
16007774|NCT02829359|Drug|Entecavir therapy|Patients in the antiviral group received entecavir begin in the first 3 days before surgery for at lest 1 month.
16007775|NCT02829346|Drug|Peri-articular tranexamic acid|750 mg of peri-articular TXA, prior to deflating the tourniquet and wound closure
16007776|NCT02829346|Drug|Intravenous tranexamic acid|750 mg of IV TXA, prior to deflating the tourniquet and wound closure
16007777|NCT02829333|Other|general anesthesia and patient controlled intravenous analgesia|Patients receive general anesthesia intraoperative period and continuous intravenous analgesia postoperation
16007778|NCT02829333|Other|spinal anesthesia and continuous postoperative epidural analgesia|Patients receive spinal anesthesia intraoperative period and continuous epidural analgesia postoperation
16007779|NCT02829320|Drug|GSK1278863|GSK1278863 will be provided as round, standard biconvex, white film coated tablets containing 1 mg, 2 mg, 4 mg or 6 mg of GSK1278863 as active ingredient.
16007780|NCT02829320|Drug|Iron|Subjects will receive supplemental iron therapy if ferritin is <=100 ng/mL and TSAT is <=20%. The investigator (or subinvestigator) will choose the route of administration and dose of prescription iron.
16007781|NCT02829307|Drug|89Zr-GSK3128349 1 mg|89Zr-GSK3128349 is a mixture of unlabelled and zirconium-labelled GSK3128349, in the form of solution for IV administration, and is associated with about 15 MBq of radioactivity.
16007782|NCT02829294|Device|E002 - cerumen removal aid|topical treatment
16007783|NCT02829281|Drug|Botulinum Toxin Type A|Joint injection of Botulinum Toxin Type A
16007784|NCT02829281|Drug|Triamcinolone hexacetonide|Joint injection of triamcinolone hexacetonide
16007785|NCT02829281|Drug|Saline|Joint injection of Saline
16007786|NCT02829268|Drug|dantrolene sodium|"The purpose of this study is to assess the safety and tolerability of dantrolene sodium in patients with Wolfram syndrome. In addition, we will assess the efficacy of dantrolene sodium on the cardinal manifestations of Wolfram syndrome, including visual acuity, remaining beta cell functions, and neurological functions.
~There is a screening period up to 56 days, a 6-month treatment period with an optional extension phase up to 24 months, and a 4-week safety follow-up period. Study assessments include medical & medication history, physical exams, neurological exams, eye exams, endocrine exams, vital signs, height, weight, electrocardiograms, blood and urine tests, pregnancy test if applicable, and questionnaires."
16007787|NCT02829255|Other|altitude exposure|altitude exposure
16007788|NCT02829242|Device|NIRS Monitoring (SenSmart Monitor)|
16007789|NCT02829229|Behavioral|Community-based obesity treatment (PP)|Participants in the treatment (PP) arm will receive a 5-component intervention: 1)Behavior change goals; 2)Self-monitoring; 3)Tailored skills training; 4)Video testimonials & 5)Interpersonal counseling. Both treatment and usual care arms will receive the current standard of care offered to postpartum mothers at WIC.
16007790|NCT02829190|Device|Magnetic Resonance Imaging (MRI),|Magnetic Resonance Imaging (MRI) of flow using phase contrast (PC) methods
16007791|NCT02829177|Drug|Allopurinol|
16007792|NCT02829177|Drug|Placebo|
16007793|NCT02829151|Drug|Triple antiplatelet therapy (aspirin (100 mg), clopidogrel (75 mg), and cilostazol (200 mg) )|Combination antiplatelet therapy using aspirin (100 mg), clopidogrel (75 mg), and cilostazol (200 mg) after the index angioplasty
16007794|NCT02829151|Drug|Dual antiplatelet therapy (aspirin (100 mg) and clopidogrel (75 mg)) using aspirin and clopidogrel|Combination antiplatelet therapy using aspirin (100 mg) and clopidogrel (75 mg) after the index angioplasty
16007795|NCT02829151|Drug|Dual antiplatelet therapy (aspirin (100 mg) and cilostazol (200 mg)) using aspirin and cilostazol|Combination antiplatelet therapy using aspirin (100 mg) and cilostazol (200 mg) after the index angioplasty
16007796|NCT02829138|Genetic|Genetic information and Omega-3 fat intake|Only the Genetic group will receive their personal genetic information prior to beginning the 3-month study.
16007797|NCT02829138|Behavioral|General Nutrition related to Omega-3 fats|Both the Genetic and Non-Genetic groups will receive general nutrition information about omega-3 fats.
16007799|NCT02829086|Other|Relationship Enhancement|Relationship Enhancement is a curriculum based program provided by a facilitator over an 8 hour skill-based education intervention.
16007800|NCT02829086|Other|Family Stress and Conflict Management|Family Stress and Conflict Management is a curriculum based program provided by a facilitator over an 8 hour skill-based education intervention.
16007801|NCT02829086|Other|Financial Management|Family Management is a curriculum based program provided by a facilitator over an 8 hour skill-based education intervention.
16007802|NCT02829073|Device|Neuromonics Tinnitus Treatment Program|The Neuromonics Oasis™ treatment device will be fit to individuals reporting significant tinnitus. Assessment of primary and secondary measures will be made at 0 and 6 months following fitting.
16007803|NCT02829073|Device|Placebo Device|A placebo device, identical to the Neuromonics Oasis™ device with altered firmware will be fit to individuals reporting significant tinnitus. Assessment of primary and secondary measures will be made at 0 and 6 months following fitting.
16007804|NCT02829060|Drug|Nitrofurantoin 100 MG, 7d|7 day course, 100 mg twice daily, PO
16007805|NCT02829060|Drug|Gentamicin, 5mg/kg|Peri-operative dose: 5 mg/kg of ideal body weight, IV
16007806|NCT02829060|Drug|Ampicillin 2g|Peri-operative dose: 2 grams, IV
16007807|NCT02829060|Drug|Nitrofurantoin 100 mg, 48 hrs|48 hour course, 100 mg twice daily, PO
16007808|NCT02829060|Drug|Gentamicin, 80 mg, 7d|7 day course, 80 mg daily, IM or IV
16071158|NCT02374567|Drug|Mirtazapine|
16007809|NCT02829060|Drug|Gentamicin, 80 mg, 48hr|48 hour course, 80 mg daily, IM or IV
16007810|NCT02829047|Device|Vibrating Capsule|Patients will receive vibrating capsule for 6 weeks of treatment (14 capsules in 3 weeks)
16007811|NCT02829034|Drug|Ranolazine|Ranolazine 500mg by mouth twice per day and after two weeks increases to 1000mg by mouth twice per day and continue for a total of 26 weeks.
16007812|NCT02829034|Drug|Placebo|Placebo by mouth twice per day for a total of 26 weeks
16007813|NCT02829021|Device|FLIR ThermaCAM P-65|Women recalled for assessment after positive screening mammography were offered dynamic infrared thermography before clinical mammography and further tests.
16007814|NCT02829008|Drug|low-dose-bevacizumab/pemetrexed|Bevacizumab is administrated at a dose of 2 mg/kg once weekly by intravenous transfusion, which is on day 1, 8 and 15, and pemetrexed is given at a dose of 500mg/m2 once on the first day by intravenous transfusion, and repeated every three weeks, too.
16007815|NCT02829008|Drug|Treatment of physician's choice|The clinicians can select any drug or regimen that has been approved in metastatic cancer at present, including monotherapy, combination therapy, target therapy and palliative therapy. Specific agents include taxanes, capecitabine, gemcitabine, vinorelbine, cisplatin,carboplatin, nutrient solutions, and so on. These agents can be administered as monotherapy or in combination.
16007816|NCT02828995|Other|Comprehensive Diabetes Stigma Survey|"The surveys to be administered in the ENDSTIGMA study are as follows:
~The Adherence to Refills and Medications for Diabetes survey is a validated, diabetes-specific survey measure utilizing patient self-report to assess diabetes medication adherence.
~The Demographics survey will be used to assess participant baseline characteristics, including body mass index (BMI). The questions contained in this survey have been validated by Dr. Kerri Cavanaugh's research group.
~Comprehensive Diabetes Stigma Survey is a novel survey being developed and validated in the ENDSTIGMA study. The ENDSTIGMA study will also compare the results from this survey with the medication adherence results, to determine if there is an association between diabetes stigma and medication adherence."
16007817|NCT02828982|Device|Powered ankle prosthesis|This device is a commercially available powered ankle prosthesis, (BioM, Bionx, Bedford, MA) which was given FDA device exempt status.
16007818|NCT02828982|Device|Dynamic Response Foot|This condition is a sham condition as the participant will wear the prosthesis they were clinically prescribed and usually wear.
16007819|NCT02828969|Other|Phone call or physical consultation|
16007820|NCT02828943|Behavioral|IMT with High Resistance EMT|
16007821|NCT02828943|Behavioral|IMT with Low Resistance EMT|
16007822|NCT02828930|Drug|Idasanutlin|Idasanutlin 300 mg tablet orally on Day 1; 400 mg tablet orally on Day 11 and Day 19. Participants, who are eligible to enter in optional treatment extension phase, will continue treatment with idasanutlin 200 mg tablet orally once daily for 5 days of 28-day cycle.
16007823|NCT02828930|Drug|Placebo|Placebo matching to idasanutlin aqueous dispersion will be administered orally on Day 11.
16007824|NCT02828930|Drug|[13C]-radiolabeled Idasanutlin|[13C]-radiolabeled idasanutlin 100 mcg will be administered as IV infusion over 15-minute on Day 1.
16007825|NCT02828930|Drug|[14C]-radiolabeled Idasanutlin|[14C]-radiolabeled idasanutlin 100 mg capsule (2, 50 mg capsules containing approximately 100 microcurie of radioactivity) will be administered orally on Day 1.
16007826|NCT02828917|Device|MedJ-01 Ridaforolimus Eluting Coronary Stent System|
16007827|NCT02828891|Device|Two-Dimensional Transcranial Doppler|Transcranial Doppler will be used to measure CSF pressure.
16007828|NCT02828878|Biological|Allogeneic MPBC transplantation from matched related donor|
16007829|NCT02828865|Device|Irreversible Electroporation (IRE) System|
16007830|NCT02828852|Other|Blood sample|"In washed platelets and whole blood, study shall determine the percentage of aggregation after activation by different agonists and the amount of certain membrane markers of platelet activation. Furthermore, an assay of estradiol plasma will be made.
~In whole blood, study will evaluate the percentage of platelet adhesion to collagen matrix or fibrinogen and the volume of thrombies formed."
16007831|NCT02828839|Procedure|Access needle|The primary purpose of the single-use disposable access needle is to guide the use of a biopsy gun to obtain a tissue sample from the patient's prostate gland through a percutaneous puncture of the perineum. The primary purpose of the disposable needle guide is to stabilize the needle biopsy and better approximate the most direct path to the prostate.
16007832|NCT02828826|Other|telephone coaching|
16007833|NCT02828800|Other|Cartography of allodynic and hypoasthetic territories|The cartography of allodynic and hypoasthetic territories will be performed by applying a tactile stimulation of an application force of 15g (for allodynia) or 0.7g (for hypoesthesia). Tracings will be plotted on tracing paper layer that will then be evaluated by the VISITRAK® tool (Smith & Nephew), validated method reproducible and standardized, enabling accurate measurement of the area concerned .
16007834|NCT02828787|Other|MRI|"The study will take place in two phases. The first phase consists of a meeting of inclusion. During this phase, the principal investigator of the study will verify the inclusion criteria for patients using a questionnaire and an interview. Then, the effects of video on each person will be tested to verify that they well induce itch and measure it using visual analogue scales. This phase will also test the benefit of the relief by scraping and cold.
~The second phase will be carried out only if the mental induction of pruritus has been possible in the first session. It involves acquiring the corresponding physiological signals fMRI. It will also be achieved during this phase an anatomical image of the brain of each participant and an image in DTI.
~The phases will be carried out in this order in each participant. They will be separated at least one night."
16007835|NCT02828774|Other|there will be no intervention.|this study is observational, procedure are done in vitro and on animal models.
16007838|NCT02828748|Other|no intervention in patients treatment, only biopsy taken|
16007839|NCT02828735|Device|respiration assessment|Respiration Breathing Exercise
16007840|NCT02828722|Other|Controlled light and noise|"Purpose: The day-night ratio of the environmental illumination (limit 8 lux) and that of the noise level (limit 20 dBA) must correspond to the necessary value required by a healthy human body as defined by the National Sleep Foundation (USA).
~Implementation: Simulation of the daytime period is performed with blue predominant artificial light with colour temperature between 5500 and 8000 K with lux values of 1000-1200 measured at the head of the patient. Simulation of the nighttime period is performed with a sleeping mask and earplugs."
16007841|NCT02828722|Other|Controlled nutrition|"In compliance with the standard daily nutrition protocol, nutrition is carried out only during daytime both in case of enteral and parenteral feeding in accordance with European Society for Clinical Nutrition and Metabolism 2016 guidelines.
~Nutritional regimen should be stopped for 8 hours/24 at night (non-nutritional period may be depending on the work schedule of the actual ICU) , even if the daily energy/protein target is not reached."
16007842|NCT02828709|Device|Irreversible Electroporation|Guided by CT and accompanied by an external spacer for fixation, needle electrodes will be placed. The amount of probes and probe placement will be attuned for specific tumour size and location, granting 15mm between the electrodes with an active tip length of 15mm. IRE pulses with pulse intensity of 1500 V/cm will be delivered in 90 consecutive pulses of 90µs.
16007843|NCT02828696|Device|"No prep treatment of worn dentition with CAD-CAM composite"|Realization of minimally invasive prostheses in PICN (CAD-CAM composite)for worn dentition. Tooth tissues are preserved: no preparation is performed and ultra-thin restorations are CAD-CAM milled.
16007844|NCT02828683|Device|PCI in patients with ST-elevation myocardial infarction|Percutaneous coronary intervention in patients with ST segment elevation myocardial infarction (STEMI)
16007845|NCT02828683|Device|PCI in patients with ST-elevation myocardial infarction|Percutaneous coronary intervention in patients with ST-segment elevatio myocardial infarction
16007846|NCT02828670|Biological|blood sample|
16007847|NCT02828670|Procedure|spleen sample|
16007848|NCT02828644|Device|EVO|videogame-like digital therapy
16007849|NCT02828631|Device|Macintosh laryngoscope|
16007850|NCT02828631|Device|McGrath videolaryngoscope|
16007851|NCT02828631|Device|Pentax videolaryngoscope|
16007852|NCT02828618|Procedure|PDS (Primary Debulkdung Surgery)|PDS with maximum effort to achieve the goal of complete gross resection
16007853|NCT02828618|Procedure|6 cycles of standard chemotherapy|6 cycles of standard chemotherapy after Primary Debuling Surgery
16007854|NCT02828618|Procedure|Timing of surgery after 3 cycles of standard NACT, IDS|Timing of surgery after 3 cycles of standard NACT
16007855|NCT02828618|Procedure|IDS|IDS with maximum effort to achieve the goal of complete gross resection after NACT
16007856|NCT02828618|Drug|3 cycles of standard chemotherapy|3 more cycles (for a total of 6) of standard chemotherapy after IDS
16007857|NCT02828605|Device|Virtual Interactive Platform (VIP) Transplant|
16007858|NCT02828592|Drug|Fludarabine|30 mg/m2 IV QD x 5 days (Days -6 to -2)
16007859|NCT02828592|Drug|Cyclophosphamide|14.5 mg/kg/day IV x 2 doses (Days -6 & -5)
16007860|NCT02828592|Radiation|Total Body Irradiation|300 cGy x1 dose (Day -1)
16007861|NCT02828592|Drug|Rabbit ATG|1.5 mg/kg/day x 3 days (Days -3 to -1)
16007862|NCT02828592|Drug|Cyclophosphamide|Post-transplant: 50 mg/kg IV QD (Day +3 to +4)
16007863|NCT02828579|Procedure|Bariatric surgery|Laparoscopic Sleeve Gastrectomy (LSG) Laparoscopic Roux-en-Y Gastric Bypass (LRYGB)
16007864|NCT02828566|Drug|IN ketamine|Intranasal ketamine 100 mg/mL solution (10 mg/kg, maximum 800 mg)
16007865|NCT02828566|Drug|IV ketamine|Intravenous ketamine 50 mg/mL solution (1 to 1.5 mg/kg, maximum 120 mg)
16007866|NCT02828566|Drug|IN saline 0.9%|Intranasal 0.9% normal saline
16007867|NCT02828566|Drug|IV saline 0.9%|Intravenous 0.9% normal saline
16007868|NCT02828553|Other|Aggressive planned ambulation with a mobility aide|A trained mobility aide will provide aggressive ambulation at least 3X per day for all patients on the heart failure unit
16007869|NCT02828540|Drug|HT047 High-dose group|HT047 2250mg, three times a day dosing schedule, 3 tablets per dose
16007870|NCT02828540|Drug|HT047 Low-dose group|HT047 1500mg, three times a day dosing schedule, 3 tablets per dose
16007871|NCT02828540|Drug|Placebo|placebo having the same appearance as HT047 Tab. 250mg
16007872|NCT02828527|Other|Observational|
16007873|NCT02828501|Procedure|Spinal Manipulation|A spinal manipulation is a high velocity, low amplitude thrust through a physiological barrier in order to elicit a cavitation.
16007874|NCT02828488|Other|No intervention|It is a descriptive study. No intervention
16007875|NCT02828475|Other|CALYPSO|Software platform of machine-learning based predictive models of surgical complication.
16007876|NCT02828475|Behavioral|Standard Care|Previous standard of care based on surgeon judgement alone.
16007877|NCT02828462|Other|CAPRI|
16007878|NCT02828449|Behavioral|therapeutic education program|
16007879|NCT02828436|Device|Precision Spectra System|Spinal Cord Stimulation
16007880|NCT02828436|Behavioral|Exercise Intervention|Standard Exercise
16007881|NCT02828423|Procedure|EMD|Regenerative surgery with EMD
16007882|NCT02828423|Procedure|BC|Regenerative surgery with BC
16007883|NCT02828410|Dietary Supplement|SBI|Serum bovine immunoglobulin protein isolate 10 g twice per day
16007884|NCT02828397|Drug|REGN2222|
16007885|NCT02828384|Other|low fodmap diet|dietary teaching
16007886|NCT02828384|Dietary Supplement|Psyllium|7.1g of psyllium daily
16007887|NCT02828371|Device|stepping verticalization|After patient positioning, the slope of the tilt table was gradually increased from 0° to 20°, 40° and then 60° in a time span of nine minutes. The stepping frequency was set at 20 steps/min for the entire treatment. Cardiovascular and respiratory parameters were continuously monitored. The net time of the session was 30 minutes
16007888|NCT02828371|Other|conventional mobilization|in-bed physiotherapy (mobilization exercises in supine and sitting position on bed, without out-of-bed mobilization nor verticalization)
16007907|NCT02828345|Other|Specimen Collection|
16007908|NCT02828332|Other|Vineland II (VABS -II)|semi-structured interview with a psychologist; Measure 4 areas: Communication, skills of daily living, socialization and skills Motrices
16007909|NCT02828332|Other|Quality of life|Evaluation of the quality of life and comorbidities
16007910|NCT02828319|Drug|Z-213|The total iron dosage is calculated based on hemoglobin value and the patients' weight, IV on day 1, 8 and 15 (if needed)
16007911|NCT02828306|Other|Patient Specific Implant|Implantation of Patient Specific Implant
16007912|NCT02828293|Other|Dynamic videofluoroscopic analysis|Patients bearing 3 different prosthesis (3 groups) will be prospactively assessed with videofluoroscopy.
16007913|NCT02828280|Device|NuMask|The NuMask is a relatively new mask ventilation device that has been registered with the FDA and used in the United States since 2006.
16007914|NCT02828280|Device|Traditional mask|A traditional air inflated facemark used to ventilate patients
16007915|NCT02828267|Behavioral|Brief Negotiational Intervention|This is a 5-10 minute conversation using the principles of motivational interviewing between the healthcare practioner and the patient to motivate the patient to identify at risk alcohol use and through self-empowerment create a plan to decrease alcohol use.
16007916|NCT02828267|Behavioral|Standard Booster|This SMS based intervention will be a text to the participant once weekly including motivational statements to try to have patients reduce their alcohol use.
16007917|NCT02828267|Behavioral|Personalized Booster|This SMS based intervention will be a text to the participant once weekly including motivational statements to try to have patients reduce their alcohol use. Information in this text will be personalized based on the participants specific reasons for reducing their alcohol use rather than a standard text content.
16007918|NCT02828254|Drug|PRI-724|
16007919|NCT02828241|Drug|DFD-04 Ointment|
16007920|NCT02828241|Other|Placebo Ointment|
16007921|NCT02828228|Drug|Vitamin D 1200 IU|Vitamin D 1200 IU once a day for 26 weeks
16007922|NCT02828228|Drug|Placebo|placebo once a day for 26 weeks
16007923|NCT02828215|Device|Swept-source optical coherence tomography (SS-OCT)|"The SD-OCT provides faster images and the ability to scan more of the central retina (macula). SD-OCT simultaneously measures multiple wavelengths of reflected light across a spectrum generating up to 40,000 A-Scans (axially sample points) per second. This allows the generation of 3 dimensional faster based volumetric images of the retina. The Spectralis OCT utilises real-time hardware eye tracking to resample lines scan enhancing the signal to noise ratio by improving the image quality.
~The swept-source OCT (SS-OCT) uses a tuneable laser light source with a longer wavelength of light (typically 1040-1050 nm) that the light source seen in more conventional SD-OCT devices. The tissue penetration and resolution is greater with fast acquisition speeds and longer line scan lengths."
16007924|NCT02828202|Other|Biological|DNA from peripheral blood mononuclear cells, RNA, plasma, serum sampled at inclusion, every 6 months and before each new systemic therapy.
16007925|NCT02828202|Other|Tissular|Primary melanoma (mostly paraffin embedded), metastatic sample (s)(paraffin embedded and frozen) from at least 1 site at inclusion and during evolution, particularly before treatment modification if clinically required.
16007926|NCT02828202|Other|Quality of life|Specific questionnaires (FACT-M, EUROQUOL) at inclusion, every 3 months and before each new systemic therapy.
16007927|NCT02828189|Other|Physical Exercise|The patients were instructed to perform autonomous physical exercise program based preferences (progressive march on flat ground, dancing, cycling, etc.). They will receive written information. The program is 9 weeks with a frequency of 3 days per week and sessions about 50 minutes long.
16007928|NCT02828189|Behavioral|Therapeutic Education|Individual Therapeutic Education about healthy habits and exercise on breast cancer.
16007929|NCT02828189|Other|Therapeutic exercise-Physiotherapy|"Cardiovascular exercise
~Individualized progressive strength and resistance exercises of principals muscle groups of the lower limbs, upper limbs and trunk.
~Flexibilization exercises"
16007930|NCT02828176|Procedure|electric cardiometry|"The following measured variables were recorded using electric cardiometry heart rate, stroke volume, cardiac output, systemic vascular resistance.
~these parameters are measured on arrival to operating room before subarachnoid block in three different angles of lateral uterine tilt ( 0, 15 and 30 degrees )"
16007931|NCT02828176|Procedure|IV line insertion|two Iv lines are inserted and 500cc crystalloid is administered to parturient .
16007932|NCT02828176|Procedure|spinal anesthesia ( subarachnoid block )|Subarachnoid block (SAB) was performed in sitting position under complete asepsis using 25 g spinal needle. SAB was achieved by intrathecal injection of 10 mg hyperbaric bupivacaine plus 25ug fentanyl. Success of SAB was tested within five minutes after drug injection. SAB was considered successful if adequate block reached T4 dermatome.
16007933|NCT02828176|Procedure|electric cardiometry|after SAB the following measured variables were recorded using electric cardiometry heart rate, stroke volume, cardiac output, systemic vascular resistance at three different angles of left uterine lilt (0,15,30 degrees)
16007934|NCT02828163|Other|Autologous Platelet rich plasma|Intralesional injection of 1 milliliter of autologous Platelet rich plasma in the oral erosions every 2 weeks for 3 months.
16007935|NCT02828163|Drug|Triamcinolone Acetonide|10mg/ml of Triamcinolone acetonide will be injected in one side of the oral mucosa of pemphigus vulgaris patients every 2 weeks for 3 months.
16007936|NCT02828150|Dietary Supplement|Parenteral nutrition|Patients will receive a tailored nutritional support (parenteral nutrition) to cover estimated protein-calorie requirements. Energy: resting energy expenditure [Harris-Benedict] multiplied by a factor of 1.5. Protein: 1.5 g/kg/day. In obese patients (BMI >30 kg/m2) support will be calculated on ideal body weight (BMI=23 kg/m2)
16007937|NCT02828124|Biological|BMS-986183|specified dose on specified days
16007938|NCT02828124|Biological|Nivolumab|specified dose on specified days
16007939|NCT02828111|Drug|Patidegib|
16007940|NCT02828111|Drug|Vehicle gel|
16007941|NCT02828098|Drug|Part 1: BO-112|Cohorts of three patients per dose level will be treated consecutively in the absence of Dose Limiting Toxicity (DLT).
16007942|NCT02828098|Drug|Part 2: BO-112|"BO-112 at a fixed dose will be administered as an intratumoral injection for up to 5 doses over 12 weeks and continue as long as there is benefit.
~Nivolumab will be administered as an intravenous infusion every 2 weeks at a dose of 3 mg/kg for up to a total period of one year.
~OR Pembrolizumab will be administered as an intravenous infusion every 3 weeks at either 200 mg or at 2 mg/kg depending on the indication, for up to a total period of one year."
16007943|NCT02828085|Biological|Nasal swab|Nasal swab will be performed in addition to the routine diagnosis visit in order to determine the diagnosis of infective pericardite with a more specific technique: PCR
16007944|NCT02828072|Other|SKY therapy|slow breathing
16007945|NCT02828072|Drug|usual drug therapy|
16007946|NCT02828059|Drug|Ropivacaine|Surgical wound Infiltration over 48 hours
16007947|NCT02828046|Biological|M281|
16007948|NCT02828046|Other|Placebo|
16007949|NCT02828033|Drug|Rilonacept|All patients will receive rilonacept with an initial loading dose of 320 mg delivered as two, 2-mL, subcutaneous injections of 160 mg each given on the same day at two different sites. The initial dose will be administered at the study site by study personnel. Dosing will then be a once-weekly injection of 160 mg administered as a single, 2-mL, subcutaneous injection by the patient at home. Patients will be dosed for 24 weeks.
16007950|NCT02828020|Drug|Ubrogepant|50 mg ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
16007951|NCT02828020|Drug|Placebo-matching Ubrogepant|Placebo-matching ubrogepant tablet(s) orally for the treatment of a qualifying migraine attack.
16007952|NCT02828007|Device|NIV Group|Each patient will be using Non Invasive Ventilation (NIV) and will use it on each possible ventilation mode in a random order with a 10 minutes washout period between modes.
16007953|NCT02827994|Other|neurophysiology of pain education and exercises|"Pain neurophysiology education covered the neurophysiology of pain, transition from acute to chronic pain and the nervous system ability to modulate the pain experience. It was delivered in small groups (4 to 7 participants). A total of 4 sessions were delivered over 4 weeks (1 session per week). Each session took between 45 minutes and 1 hour.
~Exercises were aimed at increasing the endurance and strength of the deep neck flexor and extensor muscles and of the scapular muscles delivered over 3 sessions (the first session covered pain neurophysiology education only). Each exercise was performed in 3 series of 10 repetitions. The number of exercises targeting the same group of muscles increased from one in the 2nd session to 2/3 in the 4th session."
16007954|NCT02827968|Drug|KN035|KN035 is a monoclonal antibody drug which is formulated for subcutaneous injection in a single-use vial (brown neutral borosilicate) containing a total of 300 mg antibody in 1.5 ml of solution.
16007955|NCT02827955|Device|Gamma Knife® radiosurgery bilateral|
16007956|NCT02827942|Drug|vonoprazan 20 mg bid|Vonoprazan is potent acid inhibitor. Vonoprazan 20 mg is dosed twice daily for 1 week.
16007957|NCT02827942|Drug|Amoxicillin 500 mg tid|Amoxicillin is antibiotics. Its bactericidal effect is time-dependent. Then, 500 mg of amoxicillin is dosed three times daily for 1 week.
16007958|NCT02827942|Drug|Amoxicillin 750 mg bid|Amoxicillin is antibiotics. Its bactericidal effect is time-dependent. However, the standard regimen in Japan, 750 mg of amoxicillin is dosed twice daily with clarithromycin or metronidazole for 1 week. Then, 750 mg of amoxicillin is dosed twice daily.
16007959|NCT02827942|Drug|Clarithromycin 200 mg bid|Clarithromycin is antibiotics. It is involved in the standard first line regimen in Japan. Then, 200 mg of clarithromycin is dosed twice daily for 1 week.
16007960|NCT02827942|Drug|Metronidazole 250 mg bid|Metronidazole is antimicrobial agent. It is involved in the standard second line regimen in Japan. Then, 250 mg of metronidazole is dosed twice daily for 1 week.
16007961|NCT02827929|Behavioral|Education|3 times systemic education program will be provided to patients were diagnosed as asthma or COPD by their physicians.
16007962|NCT02827916|Device|Assessment of neuropathic pain with theThermotest device|Measure of painful neuropathy with thermotest
16007963|NCT02827916|Device|Assessment of neuropathic pain with SUDOSCAN device|Measure of painful neuropathy with sudoscan Devices
16007964|NCT02827916|Device|Assessment of neuropathic pain with the Neuropathic Pain Symptom Inventory.|Measure of painful neuropathy with Neuropathic Pain Symptom Inventory.
16007965|NCT02827903|Drug|Metformin + Rosuvastatin|Group I: Metformin + Rosuvastatin,
16007966|NCT02827903|Drug|Metformin + placebo|Group II: Metformin + placebo,
16007967|NCT02827903|Drug|placebo + Rosuvastatin|Group III: placebo + Rosuvastatin
16007968|NCT02827890|Drug|Januvia Tab. 100mg|Januvia Tab. 100mg*1T/day for 5days, QD, PO
16007969|NCT02827890|Drug|Januvia Tab. 100mg + Duvie Tab. 0.5mg|Januvia Tab.100mg + Duvie Tab. 0.5mg*1T/day for 5 dyas, QD, PO
16007970|NCT02827877|Radiation|Copper Cu 64-DOTA-Trastuzumab|Given IV
16007971|NCT02827877|Other|Laboratory Biomarker Analysis|Correlative studies
16007972|NCT02827877|Biological|Pertuzumab|Given IV
16007973|NCT02827877|Procedure|Positron Emission Tomography|Undergo PET
16007974|NCT02827877|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16007975|NCT02827877|Biological|Trastuzumab|Given IV
16007976|NCT02827864|Behavioral|sequentially apply tDCS and MT|The participants in the SEQ group will first receive a-tDCS applied over M1lesioned without any active arm practice for 20 minutes. For the following 20 minutes, the participants will receive the MT, while the electrodes will be remained on the scalp without stimulation (sham tDCS). Then the electrodes will be removed from the scalp, and the participants will continue another 20 minutes of MT without tDCS. The treatment session will be ended with 30 minutes of functional task practice.
16007977|NCT02827864|Behavioral|apply tDCS concurrently|Sham tDCS will be first applied for 20 minutes without active arm practice. Twenty minutes of a-tDCS will then be applied concurrently with MT followed by another 20 minutes of MT without tDCS. The participants will also practice functional tasks for 30 minutes after MT.
16007978|NCT02827864|Behavioral|MT with sham tDCS|The training procedure will be the same as the above 2 groups except that sham tDCS will be provided in the first 40 minutes.
16007979|NCT02827851|Procedure|Liposuction|
16007980|NCT02827851|Other|SVF isolation|SVF will be isolated according to patent pending technology based on enzymatic digestion, washing and concentration of cell pellet in 5 ml of Hartmann's solution.
16007981|NCT02827851|Other|Intraarticular administration of autologous SVF|
16007982|NCT02827838|Biological|Durvalumab|Given IV
16007983|NCT02827838|Other|Laboratory Biomarker Analysis|Correlative studies
16007984|NCT02827838|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16007985|NCT02827825|Other|No intervention|No intervention. It's a study on retrospective Data
16007986|NCT02827812|Other|Comprehensive evaluation|At baseline (T0) and after 3-months (T1) all patients will be evaluated with Scales and questionnaire.
16007987|NCT02827812|Other|Physical Intervention at home|A traditional custom-tailored rehabilitative exercise program. The exercises will include functional strengthening, stretching, postural changes and balance activities; - An aerobic training on a cycle ergometer 3 days /week for three months.
16007988|NCT02827812|Other|Home-Based telemedicine program|"A nurse-tutor will follow patients through structured telephone appointments, collecting information about disease status and symptoms, offering advice regarding diet, lifestyle and medications and suggesting changes in therapy, according with the neurologist. The patient's clinical data and any suggestions made will be filled in a personal health electronic record.
~A physiotherapist-tutor will supervise the patient's home-based individualized rehabilitation program, through scheduled videoconferences."
16007989|NCT02827799|Behavioral|Cognitive Behavioral Therapy for Insomnia (CBT-I)|This behavioral intervention includes training on managing the sleep environment (stimulus control), managing dysfunctional beliefs and attitudes about sleep (cognitive therapy), relaxation (progressive muscle relaxation), changing sleep behaviors (sleep hygiene), and managing sleep duration and continuity (sleep restriction).
16007990|NCT02827799|Behavioral|Heart Failure Self-Management Education|This intervention includes learning about how to manage one's heart failure. This includes understanding when to seek treatment, monitoring oneself for daily signs and symptoms, daily weight, dietary changes, physical activity, and adherence to medication taking.
16007991|NCT02827786|Device|Electromagnetic Acoustic Imaging|Electromagnetic Acoustic imaging (EMA) is a novel experimental platform utilizing the combination of electromagnetic radio frequency (RF) and acoustic waves to enhance ultrasound images. The resultant imaging allows (based on early experimental models) tissue differentiation based on its mechanical and electrical properties. Combined with conventional US scanning, this technology potentially allows high spatial resolution imaging of a target tissue with superimposed high contrast functional information. This is a proof-of-concept pilot study in humans.
16007992|NCT02827773|Other|Talking Pill Bottle|Made by Talking Rx
16007993|NCT02827760|Dietary Supplement|Synergy1|Inulin type fructans
16007994|NCT02827760|Dietary Supplement|Maltodextrin|
16007995|NCT02827747|Other|Antioxidants (Vitamins A,C,E) plus GSH|Study medication would contain 500 milligrams of vitamin C, 400 International Units of vitamin E, and 15 milligrams of beta-carotene (the equivalent to 25,000 International Units of vitamin A).The study medication would also contain 1000mg of Glutathione (GSH).
16007996|NCT02827747|Other|Placebo|Placebo pill
16007997|NCT02827747|Dietary Supplement|Centrum|Centrum
16007998|NCT02827747|Combination Product|Dietary Sources|From dietary sources of vitamins.
16007999|NCT02827734|Device|multiple breath washout tests|
16008000|NCT02827734|Device|impulse oscillometry|
16008001|NCT02827734|Device|body plethysmography|
16008002|NCT02827721|Device|impulse oscillometry|
16008003|NCT02827721|Device|multiple breath washout test|
16008004|NCT02827721|Device|body plethysmography|
16008005|NCT02827708|Drug|semaglutide|Oral administration once daily.
16008006|NCT02827708|Drug|placebo|Oral administration once daily.
16008007|NCT02827695|Behavioral|SMASK|Medication adherence and BP monitoring
16008008|NCT02827695|Behavioral|EnhancedSC|Standard care without med reminder functions with healthy lifestyle texts
16008009|NCT02827682|Device|Angel-6000D Multiparameter Anesthesia Monitor (IoC)|The Angel-6000D Multiparameter Anesthesia Monitor, Shenzhen Weihaokang Medical Technology Co., Ltd, Guangdong, China
16008010|NCT02827682|Device|BIS VISTA Monitor (BIS)|BIS VISTA Monitor, Covidien, Changchun city shi jia trade co., Ltd, Changchun, China
16008011|NCT02827669|Behavioral|One Drop Experts Program|
16008012|NCT02827669|Behavioral|One Drop Experts Program + Apple Watch|
16008013|NCT02827656|Drug|Decapeptyl|luteal support as described and vaginal progesterone 200 mg 3 times a day
16008014|NCT02827656|Drug|hCG luteal support|luteal support as described and vaginal progesterone 200 mg 3 times a day
16008015|NCT02827643|Drug|TDF/3TC or FTC/EFV plus Calcium and vitamin D supplement|Once daily calcium carbonate 1,250 mg that equal to elemental calcium 600 mg and weekly vitamin D2 20,000international units are given in intervention arms for duration of 24 weeks the subjects in this arm continue previous ART before enrollment to the study
16008016|NCT02827643|Other|TDF/3TC or FTC/EFV|arm continue previous ART before enrollment to study without any intervention with standard for HIV-infected patient.
16008017|NCT02827630|Other|Proteus Discover|FDA cleared Wearable Sensor with Ingestible Sensor and Mobile Device Application
16008018|NCT02827630|Other|Usual Care|Routine medical care including medication titration, adherence counseling, and lifestyle coaching.
16008019|NCT02827617|Drug|Ibrutinib|Treatment with ibrutinib 420 mg quaque die in the clinical practice
16008020|NCT02827578|Drug|Tamsulosin|Tamsulosin
16008021|NCT02827578|Drug|Solifenacin|Solifenacin
16008022|NCT02827578|Drug|Solifenacin placebo|Solifenacin placebo
16008023|NCT02827565|Other|KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA|10 ml blood sample
16008024|NCT02827552|Other|skin biopsy|skin biopsy performed prior radiation to characterize in blind the individual radiosensitivity of the patient
16008025|NCT02827539|Device|LessRay|A software device has been developed that combines the benefits of reduced radiation associated with low-dose and/or pulse settings while preserving and possibly offering enhanced resolution. LessRay is a software device that is viewed on a separate monitor next to the fluro screen of the C-arm.
16008026|NCT02827539|Device|Standard Fluoroscopy|For control arm, patients will receive the standard fluoroscopy for imaging.
16008027|NCT02827526|Drug|Ketamine|
16008028|NCT02827526|Drug|Control|
16008029|NCT02827513|Drug|CTN SR1|
16008030|NCT02827513|Drug|CTN XR1|
16008031|NCT02827513|Drug|CTN XR2|
16008033|NCT02827500|Drug|ivabradine|Active Comparator: ivabradine
16008034|NCT02827500|Other|Usual Care|Placebo Comparator: usual care
16008035|NCT02827487|Drug|Tramadol|Women will receive Tramadol 100mg (Trama®, Global Napi, Giza, Egypt) orally 2 hours before IUD insertion.
16008036|NCT02827487|Drug|Celecoxib|Women will receive Celecoxib 200mg (Celebrex® 200, Pfizer, USA) orally 2 hours before IUD insertion.
16008037|NCT02827487|Drug|Placebo 1|Women will receive a placebo similar to Tramadol orally 2 hours before IUD insertion.
16008038|NCT02827487|Drug|Placebo 2|Women will receive a placebo similar to Celecoxib orally 2 hours before IUD insertion.
16008039|NCT02827487|Procedure|IUD|IUD insertion
16008040|NCT02827474|Other|Patient Interview|Patient intervention includes a 30 minute interview prior to their abortion procedure and a follow up phone-interview that will be 10-minutes and held 24-72 hours from the procedure.
16008041|NCT02827474|Other|Provider Interview|For physician participants, providers will be interviewed after completion of the patient's visit and this will be 10-15 minutes.
16008042|NCT02827435|Drug|Rocuronium bromide|Pharmacokinetic-pharmacodynamic modeling blood sampling and Rocuronium bromide concentration measure muscle relaxation evaluation
16008043|NCT02827422|Other|not provided|
16008044|NCT02827409|Procedure|Short Delay Cord Clamping|Delay cord clamping will occur for up to 1 minute. Subject will be placed on mother's abdomen for warmth and stimulation. If the subject is depressed they will be transferred to the radiant warmer for resuscitation.
16008045|NCT02827409|Procedure|Extended Delay Cord Clamping|Extended delay cord clamping will occur for at least 5 minutes and will continue until the subjects begins breathing and/or the cord stops pulsating. Subject will be placed on mother's abdomen for warmth and stimulation. If the subject is depressed they will be transferred to the LifeStart bed for resuscitation adjacent to the mother's bedside.
16008046|NCT02827396|Behavioral|Psychosocial intervention|"This training is aimed at Mothers/Fathers/Caregivers/Grandparents of children with intellectual disabilities.
~Individual (for severe mental health problems) or group counseling for similar psychological issues should be a vital ingredient of this program. The package runs for 40 hours. It will run for five days continuously. It's important to promote participatory rather than deductive approach allow a lot of time for questions and discussions."
16008047|NCT02827383|Behavioral|Stair Climbing Frequency|Includes 1 sedentary day prior to completing crossover phases.
16008048|NCT02827370|Behavioral|Behavioral Dietary Intervention|Receive dietary counseling
16008049|NCT02827357|Other|No specific intervention|Clinical, drug and data collection : characteristics of patients (age, sex and histology), non HER 2-directed treatments including response and duration of response
16008050|NCT02827344|Biological|blood sample collection for CTC and MDSC analysis|"Isolation of circulating tumor cells from 2 tubes by ISET filtration module. Peripheral blood samples will be collected for CTC analysis within 7 days before commencing treatment (defined as baseline) and following four cycles of immunotherapy,
~Analysis of PD-L1 and PD-L2 expression by immunocytochemistry on CTC
~Analysis of the expression of PD-L1, PD-L2 , CTLA4 on the histological specimen by immunohistochemistry"
16008051|NCT02827331|Other|Exposition to hypnotics or anxiolytics benzodiazepines|"Exposition to at least one drug belonging to the following classes during the last 12 months before index date :
~Benzodiazepine derivatives (N05BA)
~Benzodiazepine derivatives (N05CD)
~Benzodiazepine related drugs (N05CF)"
16008052|NCT02827331|Other|Exposition to non benzodiazepines antidepressants, hypnotics or anxiolytics|"Exposition to at least one drug belonging to the following classes during the last 12 months before index date :
~Antipsychotics (N05A)
~Antiepileptics with the exception of clonazepam (N03)
~Drugs used for alcohol dependance (N07BB)
~Drugs used for opioids dependance (N07BC)"
16008053|NCT02827331|Other|Medical consultation without prescription|Medical consultation without prescription of any drugs of interest
16008054|NCT02827331|Other|Administrative and medical data|"Gender
~Birthdate
~Department of residence
~City of residence
~Vital status (month and date of death)
~Affiliation to Universal Health Coverage
~Number of chronic long-term illness, medical diagnostic or pathology (CIM 10 code), onset and end dates
~Drugs reimbursements (Date of care onset, drugs identification code, number of box delivered)
~Data collected from medicalisation program of information system and private and public home care structures
~Medical consultations, medical acts ( Common Classification of Medical Acts nomenclature)"
16008055|NCT02827318|Dietary Supplement|Isomaltulose|75g Isomaltulose (low glycaemic load intervention)
16008056|NCT02827318|Dietary Supplement|Glucose|75g Glucose (high glycaemic load intervention)
16008057|NCT02827318|Dietary Supplement|Sweetened water|Sweetened water will be used as a control
16008058|NCT02827305|Drug|Gotukola|10 ml of mouthwash to be rinsed for duration of 60 seconds
16008059|NCT02827305|Procedure|Scaling|Ultrasonic scaling was performed in one visit on both upper and lower arches.
16008060|NCT02827292|Other|music|"A standard music with a standard volume as per the protocol will be played with headphones during the entire duration of the surgery starting from the point of induction to the time of extubation.
~A proper silent operative room environment will be maintained."
16008061|NCT02827292|Other|No music|Silent Headphones (Without music) will be applied to the patient from the point of induction of anaesthesia to the time of extubation.
16008062|NCT02827292|Procedure|Laparoscopic Surgery|Patients will undergo Laparoscopic Surgery as per the set protocol
16008063|NCT02827279|Other|emotional induction|The eye-tracking mesure the reaction at emotional induction using of sound stimuli in a group of children with or without ASD, in a context of
16008064|NCT02827266|Drug|Epoetin beta|Participants will receive epoetin beta as a weekly subcutaneous (SC) injection over an 8-week correction phase with 60 international units per kilograms (IU/kg) as starting dose. Baseline weight will be used to determine the dose and adjustments in the dose will be implemented based on the participant's blood hemoglobin levels. Participants with a response to correction treatment will then enter a 4-week extension phase to receive the SC injection every 2 weeks, and those without response will continue at the same weekly dose for a 4-week continuation phase.
16008065|NCT02827253|Device|MRI|MRI will be performed during interdialysis period in the haemodialysis group. MRI will be performed at the beginning of the study in predialysis group.
16008225|NCT02825992|Device|AcQMap System|3D imaging and mapping system for cardiac chambers
16008601|NCT02823106|Drug|Verapamil and Citicoline|Single dosing strategy will be used.
16008066|NCT02827240|Other|Oral HIV Self-Testing|The Oral HIV Self-Test is an in-home test that uses an oral swab to collect samples of oral mucosa that is used to detect the presence of HIV antibodies. The test is read after 20 minutes by the user. The test can be done by an individual at any time and place of the user's choosing. The test is read visually.
16008067|NCT02827227|Biological|lymphocytes immunophenotyping|"The lymphocytes immunophenotyping were performed from fresh EDTA-anticoagulated blood harvested during a routine follow-up of patients in HIV Lyon centers.
~HIV patients with a known history of PHI and a minimum of 2 years of effective cART (< 200 copies/mL) without interruption or virological failure were included in 2 centers in Lyon (Croix-Rousse and Edouard Herriot hospital).
~Baseline factors at the time of PHI, delay, type and duration of first and duration of total cART, CMV status, nadir CD4 cells count and level of activation markers on CD4 and CD8 cells (CD38 and HLA-DR) at the time of the study were assessed.
~Patients with hepatitis C or B virus co-infection or with a history of neoplasia or immunosuppressive therapy after the date of PIH were excluded."
16008068|NCT02827201|Drug|FOLFIRI.3|For each cycle : 1 week out of 2 - injection at Day1, J15 Irinotécan 90 mg/m² at day1 in perfusion over 60 min in Y of folinic acid Folinic Acid 400 mg/m² (or 200 mg/m² Elvorine) at Day 1 in perfusion over 2 hours 5FU continu 2000 mg/m² during 46 hours Irinotécan at 90 mg/m² in perfusion over 60 mn at Day 3 (when 5FU perfusion is over)
16008069|NCT02827201|Drug|nab-paclitaxel+ gemcitabine|For each cycle : 3 weeks out of 4 - injection at Day 1, 8 and 15 Nab-paclitaxel : 125 mg/m² of nab-paclitaxel in perfusion over 30 mn. Gemcitabine 1000 mg/m² in perfusion over 30 mn immediately after Nab paclitaxel administration is over.
16008070|NCT02827188|Other|Mega Team-videogame|Subjects randomly assigned to the treatment group will be instructed to practice Mega Team for 30-35 minutes a day, approximately 5 days a week for a minimum of 21 days and a maximum of 25 days.
16008071|NCT02827175|Other|blood sample|
16008072|NCT02827136|Drug|Lidocaine patch and hypafix|Appliance of Lidocaine patch and hypafix on both shoulder tip after anesthetic induction
16008073|NCT02827136|Drug|hypafix|Appliance of hypafix on both shoulder tip after anesthetic induction
16008074|NCT02827123|Device|McGrath MAC videolaryngoscopy|Orotracheal intubation with McGrath MAC videolaryngoscopy after anesthetic induction
16008075|NCT02827123|Drug|Macintosh Laryngoscopy|Orotracheal intubation with Macintosh Laryngoscopy after anesthetic induction
16008076|NCT02827110|Device|fiberoptic bronchoscope|Tracheal intubation using fiberoptic bronchoscope
16008077|NCT02827110|Device|pentax-airway scope|Tracheal intubation using pentax-AWS
16008078|NCT02827110|Procedure|semi-rigid collar|semi-rigid collar immobilization of the cervical spine
16008079|NCT02827097|Drug|denogan and rectus sheath block|administration of denogan and rectus sheath block with 0.375% ropivacaine
16008080|NCT02827097|Drug|denogan|administration of denogan
16008081|NCT02827084|Device|Kinesio Taping|Application of the Kinesio Taping with tension in the vatus mediallis muscle.
16008082|NCT02827084|Device|Placebo|Application of the Kinesio Taping without tension in the vatus mediallis muscle.
16008083|NCT02827058|Device|G25 pencil point needle|
16008084|NCT02827058|Device|G27 pencil point needle|
16008085|NCT02827045|Device|Vestibular test|
16008086|NCT02827032|Device|MobiusHD™|The MobiusHD device is a self-expanding nitinol implant that is delivered intravascularly to the internal carotid sinus via the delivery catheter.
16008087|NCT02827019|Other|questionnaire|a questionnaire made puerperium the 2nd day of life during the interview with the parents on the basis of a semi-structured interview about the progress of the birth and the immediate postpartum period using the memories of parents
16008088|NCT02827006|Procedure|corrective osteotomy distal radius|Opening wedge corrective osteotomy on dorsal malunions of the distal radius. Distraction and correction of deformity.
16008089|NCT02826993|Device|CCE in incomplete Colonoscopies|When the initial colonoscopy has failed, participants are invited to ingest a CCE on the day prior to their subsequent CT colonography. Thus, the CCE and CT will be compared within subjects for their ability to identify and estimate sizes of polyps
16008090|NCT02826980|Other|questionnaire|Patients consultant in gynecology in the service of Doctor Sauvanet, for whom a diagnosis of endometriosis has been established (clinical history and imaging tests confirming the diagnosis) will be offered to fill a self-administered questionnaire during their consultation
16008091|NCT02826967|Procedure|Colonic Irrigation|
16008092|NCT02826954|Other|Upper airway assessment, including nasal biopsy|
16008093|NCT02826941|Other|hypothermia|Systemic hypothermia by Cincinnati Sub-Zero Blanketrol II®, servo-controlled to 33.0 degrees C rectal temperature, started within 6hours of hypoxic ischemic birth, and continued for 48hours
16008094|NCT02826941|Other|normothermia|Rectal temperatures in neonates receiving normothermia were maintained at 37.0+or -0.5 degrees C, using overhead warmer or Cincinnati Sub-Zero Blanketrol II®, servo-controlled to rectal temperature of 37.0 degrees C.
16008095|NCT02826928|Biological|blood sample withdrawn|
16008096|NCT02826915|Device|Near Infra Red Spectroscopy (NIRS)|
16008097|NCT02826915|Device|Electroencephalogram (EEG)|
16008098|NCT02826902|Drug|propofol and remifentanil|Anesthesia is induced and maintained by effect-site target controlled infusion of propofol and remifentanil
16008099|NCT02826902|Drug|desflurane and remifentanil|Anesthesia is induced and maintained with desflurane and remifentanil
16008100|NCT02826889|Device|Philips Intelivue MP70 monitor|Philips Intelivue MP70 monitor (Intellivue MP70, Philips medical Systems, Suresnes, France) -a radial arterial cannula is inserted and arterial pressure waveforms are monitored through Philips Intelivue MP70 monitor. In the monitor, PPVauto is displayed in real-time. It is based on automatic detection algorithms, kernel smoothing, and rank-order filters.
16008101|NCT02826889|Device|Pleth Variability Index (PVI)|PVI is the measure of the dynamic changes in the Perfusion Index (PI) that occur during one or more complete respiratory cycles. A rainbow Pulse CO-Oximetry sensor is attached to the patient's finger and the PVI is displayed in real-time on the Root monitor.
16008102|NCT02826876|Drug|Topical use|Topical use of Ropivacaine in laparoscopic surgery
16008103|NCT02826876|Other|laparoscopic repair of inguinal hernia|intra-operative treatment with ropivacaine Vs placebo in laparoscopic repair of inguinal hernia
16008104|NCT02826876|Other|laparoscopic bariatric surgery|intra-operative treatment with ropivacaine Vs placebo in laparoscopic bariatric surgery
16071159|NCT02374567|Drug|Bupropion|
16008105|NCT02826863|Drug|ZX008 - 0.8 mg/kg/day|ZX008 drug product is an oral aqueous solution of fenfluramine hydrochloride buffered to pH 5 and provided in concentrations of 1.25 mg/mL, 2.5 mg/mL, and 5 mg/mL. The product is sugar free and is intended to be compatible with KD.
16008106|NCT02826863|Drug|ZX008 - 0.2 mg/kg/day|ZX008 drug product is an oral aqueous solution of fenfluramine hydrochloride buffered to pH 5 and provided in concentrations of 1.25 mg/mL, 2.5 mg/mL, and 5 mg/mL. The product is sugar free and is intended to be compatible with KD.
16008107|NCT02826863|Drug|Placebo|Placebo will be administered twice a day (BID) in equally divided doses with food.
16008108|NCT02826850|Procedure|Saphenous Nerve|Saphenous nerve neurotomy by radiofrequency, guided by ultrasound.
16008109|NCT02826850|Procedure|Genicular nerves|Genicular nerves neurotomy by radiofrequency, guided by fluoroscopy
16008110|NCT02826837|Drug|LEAC-102 500mg capsule and FOLFOX + Bevacizumab/Cetuximab|"The subjects will be administered FOLFOX + Bevacizumab/Cetuximab by intravenous infusion.
~Cycles repeat every 2 weeks. Dose and schedule modifications may be made at the treating physician's discretion.
~A standard 3+3 trial design will be used for LEAC-102 dose escalation cohorts.The dosing of LEAC-102 will be divided into 3 cohorts, the subjects will receive LEAC-102 every day
~Cohort 1: LEAC-102 500 mg capsule, 3 capsules, three times per day for 24 weeks (oral), Cohort 2: LEAC-102 500 mg capsule, 4 capsules, three times per day for 24 weeks (oral), Cohort 3: LEAC-102 500 mg capsule, 5 capsules, three times per day for 24 weeks (oral)"
16008111|NCT02826798|Drug|VBI-1501A 0.5 μg|VBI-1501A: 0.5 μg with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
16008112|NCT02826798|Drug|VBI-1501A 1.0 μg|VBI-1501A: 1.0 μg with alum with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
16008113|NCT02826798|Drug|VBI-1501A 2.0 μg|VBI-1501A: 2.0 μg with alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
16008114|NCT02826798|Drug|VBI-1501 1.0 μg|VBI-1501: 1.0 μg without alum-administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168
16008115|NCT02826798|Drug|Placebo|buffer/sucrose used for VBI-1501 suspension- administered as a 0.5 mL intramuscular injection on Days 0, 56, and 168.
16008116|NCT02826785|Behavioral|Cognitive strategy training|The intervention teaches strategies in a way that promotes generalization and enhances daily function . It includes four core elements known to enhance learning transfer: (1) self-generation of broadly applicable strategies, (2) practice across multiple contexts and activities, (3) emphasis on metacognition, and (4) use of meaningful everyday activities.
16008117|NCT02826772|Drug|GT0918|anti-tumor activity
16008118|NCT02826759|Other|diabetes|the exposure of interests are obesity, diabetes and insulin-resistance
16008119|NCT02826746|Drug|Magnesium Sulfate|adminstration of intravenous magnesium as bolus of 50 mg/kg, followed by continuous infusion at rate of 10 mg/kg/h
16008120|NCT02826746|Drug|Normal saline|the same bolus and infusion volumes of normal saline
16008121|NCT02826733|Device|Electroencephalogram (EEG)|
16008122|NCT02826733|Device|Near Infra Red Spectroscopy (NIRS)|
16008123|NCT02826733|Device|magnetic resonance imaging (MRI)|
16008124|NCT02826720|Other|No intervention was applied|No intervention was applied
16008125|NCT02826707|Behavioral|SPPAC intervention|A peer coach will deliver a physical activity counselling intervention using a Smartphone. Individualized programs will be based on participants physical activity/wheelchair mobility goals.
16008126|NCT02826694|Genetic|Well infant, whole exome sequencing|Whole exome sequencing will be performed in children with diagnosed conditions. Investigators will analyze results that are associated with their condition.
16008127|NCT02826694|Genetic|Diagnosed, whole exome sequencing|In addition to returning results of conditions associated with a child's phenotype, investigators will also analyze genes that are associated with conditions that have childhood onset and are medically actionable.
16008128|NCT02826681|Drug|Injectafer® (Ferric Carboxymaltose - FCM)|Intravenous Iron
16008129|NCT02826681|Drug|Placebo (Normal Saline)|Normal Saline Solution
16008130|NCT02826668|Other|Ultrasound|A baseline lumbar ultrasound in a standardized lateral position (by bed markings) will be performed with the midline and L3-L4 interspace marked, and estimated depth to the epidural space recorded. A second lateral lumbar ultrasound will be performed immediately prior to placement at the time of epidural request. The bed position will be standardized with lines drawn down the back, at the flexion of the knee, and heel of the foot. The sonographic measurements will include the midline, the L3-4 interspace, (both marked at the skin surface), and the measured depth to the ligamentum flavum (in centimeters).
16008131|NCT02826655|Device|WF-AO-OCT|WF-AO-OCT allows noninvasive, high-resolution imaging of the microvasculature of the retina and choroid, without intravenous dye administration. This unit is being conducted under an abbreviated IDE.
16008132|NCT02826642|Drug|IDH305|
16008133|NCT02826629|Device|Manual dexterity|Control of manual dexterity will be assessed by a force sensor (Power Grip Manipulandum, PGM)
16008134|NCT02826629|Device|Oculomotor movements|Oculomotor movements during behavioral task will be recorded using a video-oculography device
16008135|NCT02826629|Device|TMS coupled to EMG recording|The involvement of cortical inhibition in this volitional inhibition task will be studied by neuronavigation guided TMS coupled to EMG recording
16008136|NCT02826629|Other|Psychopathological evaluations|
16008137|NCT02826629|Other|Neuropsychological evaluations|
16008138|NCT02826616|Drug|Trimetazidine|Trimetazidine 60 mg 30min before PCI and 20 mg for 12 months after surgery
16008139|NCT02826603|Drug|Secukinumab|300mg, s.c. at randomization, Weeks 1, 2 and 3 and thereafter 4-weekly till Week 48
16008140|NCT02826603|Drug|Ustekinumab|Per approved label, 45 mg or 90 mg s.c. based on subject weight (at randomization visit) to be administered at randomization, Week 4, 16, 28 and 40. At other timepoints subjects will receive placebo injections.
16008141|NCT02826590|Other|Neck passive mobilizations|Passive mobilizations performed to the neck of the participant by a Physiotherapist
16008142|NCT02826590|Other|Manual contact|Manual contact applied to the neck of the participant by a Physiotherapist
16008143|NCT02826577|Drug|Pregnenolone 175mg|Single Dose 175mg
16008144|NCT02826577|Drug|Pregnenolone 400mg|Single Dose 400mg
16008145|NCT02826577|Drug|Placebo|Single Dose
16008146|NCT02826564|Drug|pembrolizumab|
16008260|NCT02825719|Drug|Ulipristal acetate|Ulipristal acetate 5mg daily will be prescribed
16008147|NCT02826551|Drug|Marcaine|Pain control medication to theoretically reduce the amount of posterior knee pain that is common after ACL surgery by placing the injection into the posterior capsule of the knee during surgery. This is very easy and safe to accomplish as the surgeon will have direct visualization of the posterior capsule during the surgery.
16008148|NCT02826551|Other|Ice|
16008149|NCT02826551|Drug|Percocet|
16008150|NCT02826551|Device|Knee Brace and Crutches|
16008151|NCT02826538|Device|fracture fixation with patient specific guides|Using the preoperative computed tomography scan, a 3D planning of the fracture Fixation is made and patient-specific guides for fracure fixation are produced using a 3D Printer. These Patient-specific guides are used for fracture fixation
16008152|NCT02826538|Device|standard procedure of fracture fixation|the standard procedure of fracure fixation for each fracture localisation is used as a standard of reference
16008153|NCT02826525|Drug|AZD4076|Investigational product
16008154|NCT02826525|Drug|Placebo|Control
16008156|NCT02826499|Device|Pediguard|It is a guide for the perforation of the pedicular channel, with a probe at its extremity. This probe allows a real time measurement of the electric conductivity of the tissues that are being crossed. The conductivity measure is translated in a sound signal. Because the cortical bone has a low conductivity, the probe will emit a low intensity sound signal. The cancellous bone has a medium conductivity. Therefore, the probe will emit a medium sound signal. However, in the event of a breach in the pedicular cortical, as blood and periost have a high conductibility, the probe will emit a intense, rapid pace, sound signal.The Pediguard technique helps thus to anticipate a cortical effraction, by detecting the proximity of the cortical wall.
16008157|NCT02826499|Other|Fluoroscopy|The placing of pedicular screws under fluoroscopic control is the most common technique as it is both reproducible and accessible. It is a two dimensional imaging technique. The profile incidence at the level of the spine is mostly used to spot the vertebral pedicle and the direction of the screw in the sagittal plane. However, there is no real control of the direction of the pedicular screw in the horizontal or frontal plane and it is an irradiating imaging technique.
16008158|NCT02826486|Drug|BL-8040|BL-8040 subcutaneous(SC) injections
16008159|NCT02826486|Drug|Pembrolizumab|pembrolizumab will be given as a 30-minute IV infusion
16008160|NCT02826486|Drug|Chemotherapy of Onivyde|• IV Onivyde® followed by IV leucovorin (LV), followed by IV fluorouracil (5-FU), every 2 weeks.
16008161|NCT02826473|Other|BRAINCHECK|Subjects of the Intervention-Group will undergo a brief cognitive assessment, using the BRAINCHECK, during hospital admission assessments. Subjects with positive results will then be referred to a Memory Clinic undergoing subsequent interdisciplinary comprehensive diagnostic examinations. Patients with established diagnosis will be invited to counselling services of the Alzheimer Association (providing social counselling).
16008162|NCT02826434|Biological|PVX-410|This is a Vaccine that will be injected intramuscularly as a mixture with an adjuvant.
16008163|NCT02826434|Biological|Durvalumab|This is an intravenous infusion of a monoclonal antibody.
16008164|NCT02826434|Drug|Hiltonol|This is an intramuscular injection of an adjuvant to enhance the immune response to vaccine.
16008165|NCT02826421|Device|UltraSert Preloaded Delivery System|Includes AcrySof IQ monofocal posterior chamber IOL Model AU00T0, intended for long term use over the lifetime of the subject
16008166|NCT02826421|Device|iTec Preloaded Delivery System|Includes TECNIS 1-piece monofocal IOL, intended for long term use over the lifetime of the subject
16008167|NCT02826421|Device|iSert Preloaded Delivery System|Includes Model 251 or Model 250 posterior chamber IOL, as selected by the Investigator, intended for long term use over the lifetime of the subject
16008168|NCT02826421|Device|Monarch III D Manual IOL Delivery System|Includes AcrySof IQ monofocal IOL posterior chamber IOL Model SN60WF, intended for long term use over the lifetime of the subject
16008169|NCT02826408|Drug|Rabeprazole sodium|WIll study effect of the medication on palpittions
16008170|NCT02826408|Drug|Pacebo|Placebo comparison to active treatment
16008171|NCT02826395|Drug|Carbon-11 Sodium Acetate|PET/CT Scans will be performed with or without oral and IV contrast. All investigational scans will be read by at least one board-certified nuclear medicine physician with established expertise in PET/CT of at least 5 years' experience. Fifteen minutes after injection of 11C-Sodium Acetate, we will acquire a scan Emission images will be acquired for 3-5min/bed position. Intravenous and oral contrast will be given for the CT portion of the study.
16008172|NCT02826382|Drug|[68Ga]P15-041|Imaging by Positron Emission Tomography after injection of [68Ga]P15-041
16008173|NCT02826369|Other|3.0 Tesla in Magnetic Resonance Imaging|"Eligible patient will have a standard MRI. The images taken before 4min30 and after 6min after to the injection of gadolimium contrast medium will be carried out with the standard image acquisition.
~The images taken between 4min30 and 6min after the injection of gadolimium contrast medium will be carried out with the compressed sensing image acquisition."
16008174|NCT02826343|Drug|Xenon129 MRI imaging|subjects will receive at baseline and 3 month post Advair intervention (See next intervention)
16008175|NCT02826343|Drug|Gadolinium MRI|subjects will receive at baseline and 3 month post Advair intervention (See next intervention)
16008176|NCT02826343|Drug|Advair (250mcg/50mcg) one puff twice a day|subjects will receive for 3 month duration between baseline and 3 month post Xenon129 MRI imaging and Gadolinium MRI.
16008177|NCT02826330|Other|biomarkers|fecal microbiota analysis antibodies in serum and saliva DNA polymorphisms
16008178|NCT02826317|Procedure|preoperative and postoperative setting|Preoperative assessment will consist on collecting demographic data as well as the presence preoperative chronic pain and its localization, preoperative opioid, gabapentin or pregabalin consumption. In postoperative, we will collect the following data: type of anesthesia, intra operative ketamine administration, type and total dose of opioid administered during surgery. Pain will be evaluated at least 2 hours after the surgery within the same day (D0) and then at day 2 (D2), 1 (M1) and 2 months (M2) after the surgery. Pain will be assessed using a 10-point NPS. If NPS >0, neuropathic pain will be diagnosed on the basis of DN4 questionnaire. NCPSP is defined by NPS >0 and positive DN4 (DN4 ≥ 4 /10) (11). APSNP and CPSNP are defined by D0/D2 DN4≥ 4/10 and M1/M2 DN4≥ 4/10, respectively.
16008261|NCT02825719|Other|Placebo pills|Placebo pills will be prescribed
16008602|NCT02823106|Other|Placebo|Single matching dosing strategy will be used.
16008179|NCT02826304|Procedure|Vaginal hysterectomy|"All the cases were performed by the same surgical team
~Incision is made at the anterior cervical lip below the bladder reflection
~Anterior peritoneal entry .
~Douglas pouch entry.
~The uterosacral ligaments and the cardinal ligaments are clamped, divided and ligated .
~Uterine artery clamping division and ligation
~After securing the uterine A., debulking procedures was performed in the form of bisection, coring or myomectomy
~Utero-ovarian and round clamping-division and ligation ( in cases where oophorectomy was performed this part was done at the level of the infundibulo-pelvic ligament).
~Hemostasis
~The vaginal vault is closed after insertion of intraperitoneal drain and"
16008180|NCT02826304|Procedure|Laparoscopic assisted vaginal hysterectomy|"Uterine manipulator was inserted through the cervix to mobilize the uterus
~Veress needle was inserted through the base of the umbilicus
~creation of pneumoperitoneum
~Insertion of 4 trocars one at the base of umbilicus for the camera and 3 lateral trocars
~The round and the utero-ovarian ligament are coagulated and divided.
~Dissection through the vesico-uterine space to displace bladder away from the cervix.
~Uterine artery was coagulated and divided laparoscopically
~anterior colpotomy over the cup of the uterine elevator.
~Vaginal part starts with opening of douglas pouch and clamping , division and ligation of uterosacral and cardinal ligaments followed by removal of the uterus and closure of the vault. reinflation to ensure proper hemostasis."
16008181|NCT02826291|Device|RD-100i, OSNA|quantitative reverse transcription polymerase chain reaction (qRT-PCR) cytokeratin-19 detection in specimen (sentinel lymph node)
16008182|NCT02826278|Other|External genitalia measurements in female newborns|
16008183|NCT02826265|Device|multiple breath washout test (MBW)|
16008184|NCT02826265|Device|impulse oscillometry (IOS)|
16008185|NCT02826265|Device|body plethysmography (BP)|
16008186|NCT02826265|Device|quantitative computed tomography (qCT)|ultra-low-dose qCT
16008187|NCT02826252|Drug|Iloprost,(Ventavis, BAYQ6256)|Ventavis (Iloprost) nebulizer solution for inhalation as 10 μg/mL (V10) and 20 μg/mL (V20).
16008188|NCT02826252|Device|I-Neb AAD system|Nebulizer, allows digital recording of inhalation data such as doses, inhalations per day and duration of inhalation (per day) etc.
16008189|NCT02826239|Device|multiple breath washout test (MBW)|measured in upright and supine position
16008190|NCT02826226|Device|multiple-breath-washout test|
16008191|NCT02826226|Drug|Bronchodilator Agents|
16008192|NCT02826213|Device|LifePort® perfusion device|Renal Perfusion with LifePort® perfusion device
16008193|NCT02826213|Device|Waves perfusion device|Renal Perfusion with Waves perfusion device
16008194|NCT02826200|Drug|Acenocoumarol|Standard of care plus oral anticoagulant therapy (acenocoumarol)
16008195|NCT02826200|Other|Standard of care|Standard of care
16008196|NCT02826187|Other|Early complications data|"Early complications of interest are :
~New arthroplasty for any reason
~Related to the implant :
~Wrong position of the implant
~Early displacement of the implant
~Related to the intervention :
~Hematoma
~Dislocation (or not causing the resumption of joint replacement)
~Deep vein thrombosis
~Pulmonary embolism
~Acute Infection"
16008197|NCT02826187|Other|Late stage complications data|"Late complications taken into account are:
~New arthroplasty for any reason
~Aseptic loosening
~Delayed hypersensitivity reaction type IV
~Solid Tumors
~Recurrent dislocation (causing or not the resumption of joint replacement)
~Allergic reactions of any kind
~Chronic infection"
16008198|NCT02826187|Other|Patient Satisfaction|Patient satisfaction evaluated by Womac reduced Score
16008199|NCT02826187|Other|Efficacity|Efficacity as evaluated by Harris HIP score
16008200|NCT02826187|Other|Radiographic evaluation|Bone reaction visible in radiography
16008201|NCT02826174|Procedure|closed PKP under topical anesthesia|a closed corneal transplantation under topical anesthesia with the anterior chamber maintained
16008202|NCT02826174|Procedure|open-sky PKP under retrobulbar anesthesia|an open-sky corneal transplantation under retrobulbar anesthesia
16008203|NCT02826174|Drug|Anti-Rejection Agents|Anti-Rejection Agents for both groups
16008204|NCT02826174|Drug|Anti-Inflammatory Agents|Anti-Inflammatory Agents for both groups
16008205|NCT02826161|Drug|Napabucasin|Napabucasin will be administered in continuous 28-day cycles. The starting dose of napabucasin is 240 mg twice daily (480 mg total daily dose) with approximately 12 hours between each dose. Napabucasin should be taken with fluids either 1 hour prior to a meal or 2 hours after a meal.
16008206|NCT02826161|Drug|Paclitaxel|Paclitaxel will be administered intravenously, once weekly, via one-hour infusion at a starting dose-level of 80 mg/m^2 body surface area. The weekly paclitaxel infusion will be given during 3 out of every 4 weeks, on days 1, 8, and 15 of each 28-day study cycle.
16008207|NCT02826148|Other|RAADS-R scale|This scale is a self-administered questionnaire completed by the person himself assisted by a clinician
16008208|NCT02826135|Procedure|abdominal compression|When there are clinical signs of hypovolemia, such as hypotension in pediatric patients with single ventricle, decreased urine output or decreased central venous pressure, right upper abdomen is gently compressed for 10 seconds. Changes of blood pressure are continuously recorded during this period. About 3 min later, intravenous colloid fluid 10 mL/kg is infused for 20 min.
16008209|NCT02826122|Device|Pai APP|Prescription: Target 100 PAI Points per week
16008210|NCT02826122|Device|FitBit APP|Prescription: Target daily 10.000 steps
16008211|NCT02826109|Device|PeriAcryl®90 HV|
16008212|NCT02826096|Behavioral|Biofeedback therapy|The brief version of biofeedback therapy is conducted by psychologists following the structure way. Biofeedback therapy is six session treatment once a week.
16008213|NCT02826083|Dietary Supplement|XXS|
16008214|NCT02826083|Dietary Supplement|non-XXS|
16008215|NCT02826070|Drug|Telbivudine|Telbivudine, 600mg, oral, daily
16008216|NCT02826070|Drug|Adefovir dipivoxil|Adefovir dipivoxil 10mg, oral, daily
16008217|NCT02826070|Other|off-treatment follow-up|
16008218|NCT02826057|Other|Targeted temperature management (33 degree Celsius)|
16008219|NCT02826044|Drug|SP2086|The study has 3 doses groups and the 30 subjects were administrated SP2086 50mg,100mg,200mg respectively.
16008220|NCT02826031|Drug|Sodium Hyaluronate Injection|
16008221|NCT02826031|Drug|DICL-SR|
16008222|NCT02826018|Drug|ALN-HBV|Ascending doses of ALN-HBV by subcutaneous (sc) injection
16008223|NCT02826018|Drug|Sterile Normal Saline (0.9% NaCl)|Calculated volume to match active comparator
16008226|NCT02825979|Procedure|Cryoballoon-based PVI|Patients randomized to first-line cryoballoon (CB) ablation will have the pulmonary vein isolation procedure performed according to standard clinical practice using the Arctic Front Cryoballoon ablation catheter. No anti-arrhythmic drugs will be prescribed in this arm.
16008227|NCT02825979|Drug|Anti-Arrhythmic Drug Therapy|Antiarrhythmic drug therapy (Class I - flecainide, propafenone; Class III - sotalol, dronedarone) will prescribed and monitored based on local clinical practice, and according to guideline-suggested drug management for symptomatic patients with paroxysmal AF.
16008228|NCT02825966|Device|AUDICOR then LifeVest then AUDICOR|Wearable Cardioverter Defibrillator to record acoustic cardiograph signals.
16008229|NCT02825953|Drug|surfactant|the investigators attempt to administer surfactant in a more gentle way, i.e. by nebulization, by minimally invasive surfactant therapy, and endotracheal bolus application of natural surfactant
16008230|NCT02825953|Device|nasal continuous positive airway pressure|each infant will be randomly assigned to nasal continuous positive airway pressure (NCPAP) or non-invasive intermittent positive-pressure ventilation (NIPPV). The infants will be stabilised on NCPAP (Neopuff; Fisher and Paykel, Auckland, New Zealand) in the delivery room and during transport to the NICU. NCPAP or NIPPV will be started within 30 min of birth immediately after randomisation. Both NCPAP and NIPPV will be delivered by a neonatal ventilator (Engström Carestation; GE Healthcare, Madison, USA) via short, binasal Cannula (RAM Cannula; Neotech, Valencia, CA).
16008231|NCT02825953|Device|non-invasive intermittent positive-pressure ventilation|each infant will be randomly assigned to nasal continuous positive airway pressure (NCPAP) or non-invasive intermittent positive-pressure ventilation (NIPPV). The infants will be stabilised on NCPAP (Neopuff; Fisher and Paykel, Auckland, New Zealand) in the delivery room and during transport to the NICU. NCPAP or NIPPV will be started within 30 min of birth immediately after randomisation. Both NCPAP and NIPPV will be delivered by a neonatal ventilator (Engström Carestation; GE Healthcare, Madison, USA) via short, binasal Cannula (RAM Cannula; Neotech, Valencia, CA).
16008232|NCT02825953|Device|Neopuff|Fisher and Paykel, Auckland, New Zealand
16008233|NCT02825953|Device|neonatal ventilator|GE Healthcare, Madison, USA
16008234|NCT02825940|Drug|Atezolizumab|Atezolizumab will be administered at a dose of 1200 mg IV q3w (in 21-day cycles), except for participants with NSCLC who will be administered atezolizumab at a dose of 1200 mg IV on Day 1.
16008235|NCT02825940|Drug|Gemcitabine|Gemcitabine will be administered to participants with NSCLC at a dose of 1250 mg/m^2 on Days 1 and 8.
16008236|NCT02825940|Drug|Cisplatin|Cisplatin will be administered to participants with NSCLC at a dose of 75 mg/m^2 on Day 1.
16008237|NCT02825927|Other|Oral screen|The oral screen is used for 30 seconds, three times a day, before meals and implies new possibilities for training of the orofacial muscles.
16008238|NCT02825914|Dietary Supplement|Casein glycomacropeptide (CGMP)|
16008239|NCT02825914|Dietary Supplement|Placebo|
16008240|NCT02825901|Dietary Supplement|Placebo|
16008241|NCT02825901|Dietary Supplement|Djulis-Buckwheat|
16008242|NCT02825901|Dietary Supplement|Buckwheat|
16008243|NCT02825875|Drug|18F DCFPyL- Radiopharmaceutica|
16008244|NCT02825862|Behavioral|Question-behaviour effect (for affective attitudes)|Investigators propose to investigate the Question-behaviour effect (omit affective attitudes). Investigators will conduct an experimental manipulation by omitting certain items from a questionnaire assessing attitudes to organ donation. Specifically, investigators will omit questions on affective attitudes. This group will complete a similar questionnaire to the comparison group, with the same number of items, but items on affective attitudes will substituted for non-affective items (e.g. on political parties).
16008245|NCT02825862|Behavioral|Question-behaviour effect (negatively-worded attitudes)|Behavioral: Question-behaviour effect (for negatively-worded attitudes) Investigators propose to investigate the Question-behaviour effect (omit negatively-worded affective attitudes). Investigators will conduct an experimental manipulation by omitting certain items from a questionnaire assessing attitudes to organ donation. Specifically, investigators will omit questions on negatively-worded affective attitudes. This group will complete a similar questionnaire to the comparison group, with the same number of items, but items on negatively-worded affective attitudes will substituted for non-affective items (e.g. on political parties).
16008246|NCT02825849|Biological|Intrauterine infusion of platelet rich plasma|Patients randomized to study group will have 30cc of blood drawn with isolation of platelet rich plasma (PRP) per standard manufacturer's protocol, with subsequent intrauterine infusion of this autologous PRP.
16008247|NCT02825836|Drug|TL-895|All participants will receive TL-895 at the dose assigned at enrollment until disease progression, withdrawal of consent, or discontinuation from the study.
16008248|NCT02825823|Dietary Supplement|Ketone Salt|
16008249|NCT02825823|Dietary Supplement|Placebo|
16008250|NCT02825810|Behavioral|Cervical motor control|Intervention will consist in a tailored exercise training following a previous published motor control protocol
16008251|NCT02825797|Drug|3BNC117|Intravenous infusion of 3BNC117
16008252|NCT02825797|Drug|10-1074|Intravenous infusion of 10-1074
16008253|NCT02825797|Other|Analytical treatment interruption|Analytical treatment interruption
16008254|NCT02825797|Drug|Placebo|Intravenous infusion of placebo (sterile saline)
16008255|NCT02825784|Dietary Supplement|Renastart|Renastart: specially formulated to meet the unique nutritional needs of children from birth to 10 years with chronic kidney disease (CKD).
16008256|NCT02825771|Behavioral|Caring Contacts Messages|Text messages expressing care and support are sent following initial meeting on the following schedule: next day, 6 weekly, 9 bi-weekly, 7 monthly; one each on birthday, holiday, and seasonal (total of 25)
16008257|NCT02825771|Behavioral|Usual Care|Usual care consists of services available to the participant in their community to reduce their suicide risk and improve their behavioral health
16008258|NCT02825758|Dietary Supplement|ZestiVits|"The study product is a low-carbohydrate, orange flavour, vitamin, mineral and trace element (micronutrient) supplement for use in ketogenic and restricted therapeutic diets, for children aged from 11 years of age and adults.
~The recommended dosage of the study product for each subject will be determined and prescribed by a dietitian. This will be based on individual requirements for micronutrient supplementation."
16008259|NCT02825745|Dietary Supplement|Betashot|Betashot is a Food for Special Medical Purposes (FSMP). Suitable for use from 3 years of age.
16071160|NCT02374567|Drug|Venlafaxine|
16008262|NCT02825719|Drug|Ferrous sulphate|Ferrous sulphate 300mg three times a day will be prescribed if haemoglobin level is less than 10g/dL.
16008263|NCT02825719|Drug|Tranexamic Acid|Tranexamic Acid 500mg four times a day on request basis will be prescribed if patient complained of menorrhagia.
16008264|NCT02825706|Other|Educational physiotherapy group|20 patients with hemophilia were randomly allocated to an educational intervention or to a control group. The educational intervention was performed every two weeks during 15-week and home exercises were performed once a day, 6 days a week, in the same time
16008265|NCT02825693|Procedure|Conventional cataract surgery (phacoemulsification)|
16008266|NCT02825693|Procedure|Femtosecond laser assisted cataract surgery|
16008267|NCT02825680|Other|Enhanced NCP Support|NCP is a central policy office that provides support to MOVE! program teams through monthly phone calls and technical assistance. Facilities will also have access to the audit and feedback process and barrier buster tool
16008268|NCT02825680|Other|LEAP|The Learn. Engage. Act. Process (LEAP) intervention relies on virtual (phone and online) coaching based on the IHI Model for Improvement, an online learning platform for clinician teams to share ideas and progress, an audit and feedback process, and a barrier buster tool.
16008269|NCT02825667|Other|Physiotherapy sessions|Physiotherapy by techniques myofascial therapy, in patients with ankle hemophilic arthropathy
16008270|NCT02825641|Drug|Oxytocin|"Labor induction and cervical ripening by oxytocin in women with premature rupture of membranes in 2 types of women:
~Induction of labor on presentation at the delivery room.
~Induction of labor after 24 hours of rupture of membranes."
16008271|NCT02825641|Drug|Dinoprostone|"Labor induction and cervical ripening by dinoprostone in women with premature rupture of membranes in 2 types of women:
~Induction of labor on presentation at the delivery room.
~Induction of labor after 24 hours of rupture of membranes."
16008272|NCT02825628|Drug|Osteodex|formulation: solution for infusion route of administration: intravenous infusion
16008273|NCT02825615|Procedure|Radial artery cannulation|Radial artery cannulation done with conventional and ultrasound guidance in two respective groups of patients and their first pass success and ultimate success rates compared in different hemodynamic subsets of the patients.
16008274|NCT02825589|Device|BIA|BIA or bioelectrical impedance analysis using electric current through body tissues to estimate body composition particularly body fat and total body water calculating to target body weight.
16008275|NCT02825576|Drug|Sugammadex|Sugammadex 2mg/kg given for reversal agent
16008276|NCT02825576|Drug|Neostigmine/Glycopyrrolate|Neostigmine 50 mcg/kg plus Glycopyrrolate 10 mcg/kg given for reversal agent
16008277|NCT02825563|Drug|Anlotinib|in the fasting state
16008278|NCT02825563|Drug|Anlotinib|in the high fat diet
16008279|NCT02825550|Device|Taiwan ACE Beads|Similar with conventional TACE, radiologist inject lipiodol with doxorubicin first, then use Taiwan ACE Beads instead of Gelfoam or polyvinyl alcohol.
16008280|NCT02825537|Device|Compression stocking|A class III (20 to 36 mm Hg) elastic compression stocking according to the french classification
16008281|NCT02825537|Other|No use of compression stocking|No use of compression stocking
16008282|NCT02825524|Device|Habib™ EndoHBP|During an endoscopic retrograde cholangiography, endobiliary application of radiofrequency through a dedicated probe named Habib.
16008283|NCT02825498|Device|Contact force guided RFA|Contact force guided RFA during Atrial Flutter ablation procedure.
16008284|NCT02825485|Procedure|Voiding cystourethrogram|
16008285|NCT02825472|Behavioral|exercise training|3 times per week 30 minutes of exercise training in the target heart rate zone
16008286|NCT02825459|Behavioral|Abstinence from e-cigarettes|Abrupt cessation for 6 days
16008287|NCT02825446|Procedure|angioplasty tibial arteries|"Under local anesthesia using the standard endovascular access and renders the affected arterial segment. Are stenosis or occlusion of the artery, the hydrophilic guide. Occlusion or subintimal perform transluminal recanalization of the artery. Then do balloon angioplastic stenosis or occlusion.
~Drug therapy includes the administration of aspirin before the procedure (160-300 mg/day) starting at least one day, and heparin during the procedure (5000 IU intravenously). After the procedure, all patients are administered aspirin (100 mg daily) for a long time."
16008288|NCT02825446|Procedure|"angioplasty tibial arteries augmented radio frequency denervation popliteal artery by the useVessix Renal Denervation System Balloon"|"Under local anesthesia using the standard endovascular access and renders the affected arterial segment. Are stenosis or occlusion of the artery, the hydrophilic guide. Occlusion or subintimal perform transluminal recanalization of the artery. Then do balloon angioplastic stenosis or occlusion. Then in 3 portion of the popliteal artery starts ablation by the use Vessix Renal Denervation System Balloon performed radiofrequency denervation. After removal of the balloon, control angiography is performed.
~Drug therapy includes the administration of aspirin before the procedure (160-300 mg/day) starting at least one day, and heparin during the procedure (5000 IU intravenously). After the procedure, all patients are administered aspirin (100 mg daily) for a long time."
16008289|NCT02825433|Other|No intervention, only ventilation monitoring|
16008291|NCT02825407|Dietary Supplement|Oral physiology|
16008292|NCT02825394|Other|anti-Xa activity point-of-care testing (aXa-POCT)|
16008293|NCT02825394|Other|ecarin clotting time point-of-care testing (ECT-POCT)|
16008294|NCT02825368|Biological|MMR|0.5 mL, subcutaneous
16008295|NCT02825368|Biological|Tdap|0.5 mL, intramuscular
16008296|NCT02825368|Other|Diphtherinum®|
16008297|NCT02825368|Other|Pertussinum®|
16008298|NCT02825368|Other|Tetanotxicum®|
16008299|NCT02825368|Other|Morbilinum®|
16008300|NCT02825368|Other|Ourlianum®|
16008301|NCT02825368|Other|Sterile saline|0.5 mL, intramuscular
16008302|NCT02825368|Other|Sugar pellets|
16008303|NCT02825342|Drug|Citalopram|
16008304|NCT02825329|Device|TORAYMYXIN PMX-20R|Two (2) PMX cartridges will be administered approximately 24 hours apart. PMX Cartridge is an extracorporeal hemoperfusion device. Each treatment will target 2 hours with a minimum of 1 ½ hours, at a flow rate of approximately 100 ml/minute, (range of 80 to 120 ml/minute).
16008305|NCT02825316|Behavioral|Mediterranean diet|Eight weeks course of Mediterranean diet (rich in plant-based food and low in animal protein and fat).
16008700|NCT02822352|Other|Chromoendoscopy|High definition virtual chromoendoscopy
16008306|NCT02825316|Behavioral|Low residue diet|Eight weeks course of low residue diet (minimal consumption of foods that add residue to the stool, such as raw fruits, vegetables and seeds, as well as nuts, legumes and whole grains).
16008307|NCT02825303|Other|Workplace consisting of two height-adjustable desks|Desk arrangements: self-determined by the participants Desk equipment: depending on pre-intervention condition - 1 or 2 screens per desk Build-up: one day prior to the intervention period at the location of the workplace Adjustment: together with the study leader
16008308|NCT02825290|Drug|Choriogonadotropin alfa|
16008309|NCT02825290|Drug|Triptorelin acetate|
16008310|NCT02825277|Device|Doppler|acquisition of 3D power Doppler of uteroplacental vascularization unit in 72h before delivery and morphological analysis for placenta
16008311|NCT02825264|Device|STARflo Implant|All patients who have been implanted with STARflo implant from 2011 will be offered to participate to this data collection
16008312|NCT02825251|Drug|Faster-acting insulin aspart|Injected s.c. /subcutaneously (under the skin)
16008313|NCT02825251|Drug|insulin aspart|Injected s.c. /subcutaneously (under the skin)
16008314|NCT02825238|Other|Supervised exercise program|
16008315|NCT02825225|Other|20 core-biopsy fragments|Using the extended sextant fashion prostate biopsy, this randomized group was submitted to a 20-fragments core-biopsy to evaluate the diagnostic power, pain perception and complications comparative to institution's standard 12 cores.
16008316|NCT02825225|Procedure|Base and apex local anesthesia|Using the institution's standard local anesthesia protocol (base injection) as active comparator group, this randomized group was submitted to base and apex local anesthetic application to evaluate tolerability of the procedure, pain perception (with use of previous validated analogue pain scale) and complications.
16008317|NCT02825212|Drug|Harvoni|12 weeks for naïve subjects or non-cirrhotic treatment experienced subjects; or 24 weeks for treatment experienced subjects with cirrhosis
16008318|NCT02825212|Drug|Epclusa|once daily for 12 weeks (naïve subjects, non-cirrhotic treatment experienced or treatment experienced subjects with compensated cirrhosis) for genotype 1-6 subjects.
16008319|NCT02825199|Dietary Supplement|Caffeine|capsule: 300mg caffeine
16008320|NCT02825199|Dietary Supplement|Non caffeine|capsule: placebo (maize starch)
16008321|NCT02825186|Drug|Loteprendol etabonate 0.5%|Steroid eye drops used after strabismus surgery.
16008322|NCT02825186|Drug|Dexamethasone 0.1%|
16008323|NCT02825173|Device|Seal-G|"Intervention:
~Device: Seal-G Seal-G is applied adjunctively to cover standard closure techniques"
16008324|NCT02825160|Drug|Ventavis (Iloprost, BAYQ6256)|The treatment of Ventavis should comply with the local product information
16008325|NCT02825147|Drug|Pegaspargase|
16008326|NCT02825147|Drug|Methotrexate|
16008327|NCT02825147|Drug|Dexamethasone|
16008328|NCT02825147|Drug|Etoposide|
16008329|NCT02825147|Radiation|radiotherapy|
16008330|NCT02825134|Device|Transcatheter aortic valve replacement|Retrograde transfemoral transcatheter aortic valve replacement with any CE mark approved aortic bioprosthesis with or without concomitant percutaneous coronary intervention.
16008331|NCT02825134|Device|Surgical aortic valve replacement|Conventional surgical aortic valve replacement with a bioprosthesis using normothermic cardiopulmonary bypass and cold blood cardioplegia cardiac arrest with or without concomitant coronary artery bypass graft surgery.
16008332|NCT02825121|Device|Monitoring Neuromuscular Blockade the Flexor Hallucis|
16008333|NCT02825121|Device|Monitoring Neuromuscular Blockade adductor of the thumb.|
16008334|NCT02825108|Drug|Intra uterine injection of tissue culture medium containing HCG+ET|40 μL of tissue culture medium (G.2plus ref. 10132, Vitrolife) containing either 500 IU of hCG (Choriomon®, IBSA SA, Switzerland) is injected intrauterine, approximately 7 minutes before embryo transfer.
16008335|NCT02825108|Drug|Intra uterine injection of tissue culture medium +ET|) only 40 μL of tissue culture medium (G.2plus ref. 10132, Vitrolife) is injected intrauterine, approximately 7 minutes before embryo transfer.
16008336|NCT02825108|Procedure|ET|the embryo transfer ( ET) is done without the intrauterine hCG injection. The ET procedure is performed just like in the other two groups.
16008337|NCT02825095|Procedure|Talc Pleurodesis|chest tube type PIGTAIL 10 - 14 Fr will be inserted to the pleural space. In case of fluid discharges less than 250 cc/24, talc pleurodesis will be performed
16008338|NCT02825095|Procedure|Indwelling Pleural Catheter|Indwelling Pleural Catheter type PLEURAX will be inserted to the pleural space. the patients will be discharged with the pleural catheter.
16008339|NCT02825095|Procedure|chest ultrasound|All insertion of a chest drain will be guided by ultrasound
16008340|NCT02825095|Drug|Local anesthesia|Inserting a chest drain will be after local anesthesia with 10-20 mL of Lidocaine hydrochloride 20MG/ML - Esracain injection 2%
16008341|NCT02825095|Procedure|Chest Tube|chest tube type PIGTAIL 10 - 14 Fr will be inserted to the pleural space. In case of fluid discharges less than 250 cc/24, talc pleurodesis will be performed
16008342|NCT02825082|Procedure|Abdominal emergency surgery|all abdominal emergency surgery procedures
16008343|NCT02825069|Other|Early introduction of solid foods|Early introduction of solid foods
16008344|NCT02825056|Drug|Bupivacaine|Intrathecal local anesthetic drug,Bupivacaine will be delivered in L3-L4 space.
16008345|NCT02825056|Drug|Bupivacaine + Morphine|Intrathecal local anesthetic drug,Bupivacaine and Morphine will be delivered in L3-L4 space.
16008346|NCT02825043|Device|High-Flow Nasal Cannula|This is a humidified oxygen delivery system.
16008347|NCT02825030|Drug|Coppertone (BAY 987516)|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.(Formulation-SR15-78_Y73-167).
16008348|NCT02825017|Drug|Coppertone (BAY 987517)|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2mg/cm*2 test application.(Formulation-SR15-79_Y73-161)
16008349|NCT02825004|Behavioral|Psychological Intervention|
16008350|NCT02824991|Procedure|detection of local twitch response intensities during dry needling|
16008351|NCT02824965|Drug|Pembrolizumab|Pembrolizumab is a selective monoclonal antibody that blocks the interaction between PD1 and its ligands PDL1 and PDL2, resulting in infiltration of tumour specific CD8+ T-cells and ultimately leads to tumour rejection.
16008933|NCT02820584|Biological|GSC-loaded autologous dendritic cells|
16008352|NCT02824965|Biological|CVA21|CAVATAK is an oncolytic Coxsackie virus that specifically infects and kills ICAM overexpressing tumour cells
16008353|NCT02824952|Drug|Tagrisso|taking orally everyday for 6 or 12 weeks.
16008354|NCT02824939|Other|Transversus Abdominis Plane (TAP) Block|0.5 ml/kg of 0.25 % Bupivacaine deposited in the transversus abdominis plane under ultrasound guidance postoperatively
16008355|NCT02824939|Other|Quadratus Lumborum (QL) Block|0.5 ml/kg of 0.25 % Bupivacaine deposited in the anterolateral aspect of the quadratus lumborum muscle under ultrasound guidance postoperatively
16008356|NCT02824926|Drug|Dapaconazole|
16008357|NCT02824926|Drug|Ketoconazole|
16008358|NCT02824913|Drug|P-321 Ophthalmic Solution|
16008359|NCT02824913|Drug|P-321 Ophthalmic Solution placebo|
16008360|NCT02824900|Device|Vibration stimuli to neck muscles|
16008361|NCT02824900|Device|Vibration stimuli to hand|
16008362|NCT02824900|Behavioral|conventional physiotherapy|
16008363|NCT02824887|Other|Electro-acupuncture|Electro acupuncture deep needling protrusion of lumbar intervertebral disc the five acupoints
16008364|NCT02824887|Other|Conventional treatment of Western Medicine|Routine non operative treatment of Western Medicine
16008365|NCT02824874|Drug|Duvie Tab. 0.5mg|Duvie Tab. 0.5mg*1T/day for 5days, QD, PO
16008366|NCT02824874|Drug|Duvie Tab. 0.5mg + Januvia Tab. 100mg|Duvie Tab. 0.5mg + Januvia Tab.100mg*1T/day for 5 dyas, QD, PO
16008367|NCT02824861|Behavioral|Bemobile|
16008368|NCT02824848|Behavioral|Passive Stretching|Passive stretching and associated strengthening activities to change head/neck and body alignment
16008369|NCT02824848|Behavioral|Perception-Action Approach|Environmental set-up and gentle manual guidance to promote spontaneous exploration of alternative head/neck and body alignment possibilities
16008370|NCT02824835|Procedure|biopsy during colonoscopy|sampling the lesion with forcept biopter
16008371|NCT02824796|Behavioral|Schema Parent Behavioral Training|A novel protocol for parent whose children suffer from ADHD and comorbidities. The protocol combines elements from Schema Focus Therapy (SFT) and Parent Behavioral Training (PBT)
16008372|NCT02824796|Behavioral|Parent Behavioral Training|A state of the art Parent Behavioral Treatment (PBT) for Children who suffer from ADHD symptoms
16008373|NCT02824770|Behavioral|Dimming of lights and decreasing noise level|The study intervention will include dimming of lights and decreasing noise level. The lights will be dimmed to 40 lux and the doors of the side-room will be closed to decrease the noise level below 40 dB between 11:00 p.m.-5:00 a.m
16008374|NCT02824770|Drug|Bupivacaine (Bustesin®) via Pain Buster ® system|Patients will receive continous infusion of Bupivacaine (Bustesin®) via Pain Buster ® system into the wound at a rate of 5cc/hour
16008375|NCT02824770|Drug|Tramadol HCl (Tramosel®) via PCA system (Gemstar®)|Patients will receive infusion of Tramadol HCl (Tramosel®) via patient-controlled analgesia system (Gemstar®)
16008376|NCT02824770|Procedure|Major abdominal surgery|Any major abdominal surgery (e.g. colectomy, gastrectomy)
16008377|NCT02824744|Device|treatment by 2l/min/kg in High Flow Nasal cannula (HFNC)|
16008378|NCT02824744|Device|treatment by 3l/min/kg in High Flow Nasal cannula (HFNC)|
16008379|NCT02824731|Radiation|Radiation with protons|
16008380|NCT02824731|Radiation|Radiation with photons|
16008381|NCT02824718|Drug|Teriparatide|human recombinant parathormone
16008382|NCT02824718|Drug|Thiazide|Diuretic
16008383|NCT02824718|Drug|Potassium sparing diuretic|Diuretic
16008384|NCT02824718|Drug|Alfacalcidol|Belongs to the class of vitamin D and analogues
16008385|NCT02824705|Procedure|Congenital Heart Disease Surgery|Stool and blood sample collected prior to surgical intervention for congenital heart disease; stool and blood samples then collected in days following cardiac intervention.
16008386|NCT02824692|Device|heart lungs and abdomen ultrasound|
16008387|NCT02824679|Drug|hyoscine butylbromide|20 - 40 mg of hyoscine butylbromide is given intravenously during the first stage of labor
16008388|NCT02824679|Drug|saline|0.9%normal saline
16008389|NCT02824666|Drug|ATI-9242|"Formulated ATI-9242 will be administered as an IV bolus injection (2mg/mL of ATI-9242 in 40% solution of propylene glycol).
~Two doses will be tested: single IV bolus injection of 0.5mg/kg and single IV bolus injection 1.0 mg/kg. In the event that a third cohort is needed the IV bolus injection would be 2.0 mg/kg"
16008390|NCT02824666|Radiation|[18F]Fallypride Imaging|Subjects will be injected with approximately 250 MBq or 6.75 mCi of [18F]Fallypride [5-6 mCi being the typical range of injected dose].
16008391|NCT02824653|Biological|Mesenchymal Stem Cells|Allogenic Human Bone Marrow Mesenchymal Stem Cells (ex-vivo expanded in pooled human platelet lysate)
16008392|NCT02824640|Behavioral|Patient Navigation|The study will follow a PN model (Check Hep C) developed by NYCDOH in collaboration with Montefiore and the community. HCV PNs will provide the following interventions to those randomized to the PN arm: coordination of HCV treatment; health promotion; assisting patients to overcome barriers; and psychosocial support.
16008393|NCT02824640|Behavioral|modified Directly Observed Therapy|Subjects will be observed taking medications, a minimum of 5 times a week for those enrolled in the OAT setting, and a minimum of 3 times a week for those enrolled in the community health clinic setting.
16008394|NCT02824627|Drug|Oxytocin|A growing body of data shows that intra-nasal administration of oxytocin has promise for treating a host of psychiatric disorders. Considerable data indicates that oxytocin reduces amygdala response to negative stimuli in patients with generalized anxiety disorder, borderline personality disorder, and post-traumatic stress disorder. Given that one of the potential underlying neurobiological mechanisms of irritability and emotional dysregulation in pediatric population with disruptive behavior and mood disorder is the hyperactivity of amygdala to negative emotional stimuli, and that oxytocin reduces this, it is critical to determine the extent to which this intervention improves irritability and emotional dysregulation in children and adolescents with disruptive behavior and mood disorders.
16008395|NCT02824627|Drug|Placebo|Inactive substance administered in volume equivalent to volume administered in active treatment arm.
16008396|NCT02824614|Dietary Supplement|E967-Xylitol|
16008397|NCT02824614|Dietary Supplement|E968-Erythritol|
16008437|NCT02824302|Other|Survey|Patients coming for induction of labor will be handed a survey regarding their expectation of their coming labor pain. And then will be followed up after 24 hours of their delivery.
16008398|NCT02824601|Device|Laser|1-visit-treatment (n=12): Chemomechanical preparation (CMP) - CMP was performed by using the single-file reciprocating technique + 2.5% NaOCL and 17% EDTA. Methylene blue was applied to root canals for 60 seconds and submitted to laser with a potency of 60 mW and energy density of 129 J/cm2 for 120 seconds after CMP
16008399|NCT02824601|Drug|Calcium hydroxide|2-visit-treatment (n=12): Chemomechanical preparation (CMP) + Ca(OH)2 + SSL medication for 14-days + PDT. CMP was performed by using the single-file reciprocating technique + 2.5% NaOCL and 17% EDTA. Methylene blue was applied to root canals for 60 seconds and submitted to laser with a potency of 60 mW and energy density of 129 J/cm2 for 120 seconds after 14-days of intracanal medication
16008400|NCT02824588|Behavioral|Working Memory Training|Training mental flexibility
16008401|NCT02824588|Behavioral|Internet use|Used as control for time spent on computer
16008402|NCT02824575|Drug|Rebastinib|50 mg or 100 mg po BID continuously. Cycle duration: 21 days. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
16008403|NCT02824575|Drug|Paclitaxel|Paclitaxel 80 mg/m2 weekly. Cycle duration = 21 days. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
16008404|NCT02824575|Drug|Eribulin Mesylate|Eribulin 1.4 mg/m2 day 1 & 8. Cycle duration : 21 days. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
16008405|NCT02824562|Behavioral|Intervention|The intervention group will receive treatment as usual plus a chronic pain self-management program which includes six one-on-one sessions facilitated by a trained interventionist and six group sessions facilitated by a trained interventionist and a peer. A peer is an HIV-infected patient living with chronic pain, who has completed all ten of the one-on-one sessions offered, received training to co-facilitate the six group sessions with the interventionist, and is successfully self-managing his/her chronic pain.
16008406|NCT02824562|Behavioral|Control|"The control group will receive treatment as usual. The treatment as usual or control group refers to the standard of care that patients receive for their chronic pain. This standard of care allows patients to discuss chronic pain with their providers at their discretion. Although highly variable, providers can recommend and prescribe pharmacologic (e.g., opioid and other pain medication), non-pharmacologic (e.g., physical therapy, referral to psychology) approaches for pain. This study will not interfere in any way with usual care. No additional treatment will be provided to participants allocated to the control group."
16008407|NCT02824549|Device|FreeStyle Libre Flash Glucose Monitoring|
16008408|NCT02824536|Drug|3BNC117|Intravenous Infusion of 3BNC117
16008409|NCT02824536|Drug|10-1074|Intravenous Infusion of 10-1074
16008410|NCT02824536|Drug|Placebo|Intravenous Infusion of Sterile Saline (NaCl 0.9%)
16008411|NCT02824523|Drug|aspirin|
16008412|NCT02824510|Other|Algorithmic changes in insulin therapy.|Based on SG evolution in first treadmill test, algorithms will evaluate the modifications in insulin therapy required to normalize SG during the second treadmill test.
16008413|NCT02824510|Other|Treadmill exercises|25 min treadmill exercise at 60% of maximal heart rate estimated for age
16008414|NCT02824510|Drug|Insulin aspart, glargine and detemir|
16008415|NCT02824497|Other|No intervention. It's a description study|
16008416|NCT02824484|Behavioral|GWDP|"In each writing session participants are asked to:
~Describe memories concerning cancer illness in a chronological order, with an objective and detached attitude
~Describe: (a) thoughts and emotions perceived during the illness experience; (b) the impact of illness on their daily lives, and how it has changed their attitudes toward life.
~Focus on their actual situation, think about the entire illness experience, and report on the following aspects: -Their present thoughts and feelings, and how those differ from the ones felt during the illness experience. -To what extent they have come to terms with, understand and appreciate themselves to have dealt successfully with the illness."
16008417|NCT02824484|Behavioral|Control|Participants are requested to write about events of their daily routine happened during the past week; they are also asked to focus on facts, with an objective and detached attitude.
16008418|NCT02824471|Other|SCD Group|No Intervention. Use of discard blood/tissue
16008419|NCT02824458|Drug|Apatinib|Patients will be treated with Apatinib, 250/500/750 mg(dose determined from Part A of study) p.o., daily
16008420|NCT02824458|Drug|Gefitinib|Patients will be treated with Gefitinib, 250 mg p.o., daily
16008421|NCT02824458|Drug|Placebo|
16008422|NCT02824445|Device|individualized Transcranial Magnetic Stimulation|
16008423|NCT02824432|Drug|TAK-085|TAK-085 capsules
16008424|NCT02824419|Drug|Methionine|Subject undergoes imaging studies with FDG and with methionine.
16008425|NCT02824419|Drug|DOTANOC|Subject undergoes imaging studies with FDG and with DOTANOC.
16008426|NCT02824406|Drug|Acetazolamide|Acetazolamide is administered to all participants to induce vasodilation, in order to assess the physiologic response on cerebral blood flow.
16008427|NCT02824393|Biological|Autologous mesenchymal stem cell|Intravenous infusion of ex vivo cultured adipose tissue derived autologous mesenchymal stem cells, twice at two week intervals in total 1x10/6 cells/kg.
16008428|NCT02824380|Drug|DA-4001 H|5% minoxidil / high dose of finasteride
16008429|NCT02824380|Drug|DA-4001 L|5% minoxidil / low dose of finasteride
16008430|NCT02824367|Behavioral|Completion of scales evaluation|Patient complete scores to perfectionism scales (Frost Multidimensional Perfectionism Scales (FMPS), Hewitt Multidimensional Perfectionism Scale (HMPS), scores to depression scale (Beck Depression Inventory (BDI)) and anxiety scale (State Trait Anxiety Inventory (STAI))
16008431|NCT02824354|Drug|Nalmefene (Selincro®) 18 mg tablet|Evaluate the efficacy, tolerability and safety of nalmefene for reduction of alcohol consumption (reduction of the number of monthly heavy drinking days, and daily total alcohol consumption) in alcohol-dependent patients with alcoholic compensated cirrhosis.
16008432|NCT02824354|Drug|placebo|Evaluate the efficacy, tolerability and safety of nalmefene for reduction of alcohol consumption (reduction of the number of monthly heavy drinking days, and daily total alcohol consumption) in alcohol-dependent patients with alcoholic compensated cirrhosis.
16008433|NCT02824341|Device|fMRI|
16008434|NCT02824315|Drug|AL-335|AL--335 800 mg once daily on Days 1--3, 24--26 and 34--36.
16008435|NCT02824315|Drug|Odalasvir (ODV)|ODV 150 mg on Day 14 and 50 mg once daily on Days 15--23, 24--26, 27--33 and 34--36.
16008436|NCT02824315|Drug|Simeprevir (SMV)|Simeprevir 75 mg once daily on Days 4-13, 27--33 and 34--36.
16008934|NCT02820558|Drug|Substance P|
16008438|NCT02824289|Behavioral|Sun Safe Workplaces Program|The intervention began by sending a Program Announcement Packet and requesting the first face-to-face meeting. At the first meeting, intervention staff covered: 1) Introduction to SSW; 2) Sun Safety Practices in the Workplace; 3) Sun Safety Policy for Outdoor Workers; 4) Sun Safety Policy Adoption; 5) Sun Safety Policy Reinforcement and Maintenance. They presented the SSW Website and a Sun Safety Tool Box. Following the first meeting, the manager scheduled Sun Safety Training by intervention staff with various employee groups. Workplace Sun Safety Materials were sent in four sets (twice a year over two years) for distribution to employees. Research staff made monthly Follow-up Contacts with managers.
16008439|NCT02824289|Behavioral|Attention Control|Research staff sent printed materials on occupational sun safety to local government organizations twice. These included posters with personal protection messages and skin cancer rates, risk assessment brochures, worksite guides, total skin self-examination CD-Rom, the American Academy of Dermatology SPOT bookmark, and a sun safety tip card from the Occupational Safety and Health Administration (OSHA). Staff made presentations on general sun safety topics (not policy) at state professional conferences.
16008440|NCT02824276|Drug|Oxycodone or morphine sulfate immediate release (MSIR)|Oxycodone or morphine sulfate immediate release (MSIR)
16008441|NCT02824276|Drug|Placebo Treatment|Lactose (Appearance and Weight-matched placebo capsules)
16008442|NCT02824263|Other|CPAP withdrawal|CPAP is discontinued for 3 nights.
16008443|NCT02824250|Behavioral|MBSR|Mindfulness-Based Stress Reduction (MBSR) is an 8-week classroom based program of mindfulness meditation and gentle yoga.
16008444|NCT02824237|Device|Improved cook stove|The investigators will conduct a pre-post intervention study to evaluate effectiveness of improved stoves and compare outcomes after two years
16008445|NCT02824224|Drug|Tamoxifen|10mg PO (by mouth) twice daily for 7 days starting on day 21 after IUD insertion for one course
16008446|NCT02824224|Drug|Placebo (for Tamoxifen)|Sugar pill manufactured to mimic the tamoxifen 10mg tablet
16008447|NCT02824211|Device|Right Dose System|Automated titration of oxygen system during exertion
16008448|NCT02824198|Biological|CYD Dengue Vaccine (5 dose formulation)|0.5 mL, Subcutaneous
16008449|NCT02824198|Biological|Placebo, NaCl 0.9%|0.5 mL, Subcutaneous
16008450|NCT02824185|Device|PET/MRI system (SIEMENS AG, Munich, Germany; distributed in France by SIEMENS S.A.S, Saint-Denis, France)|A PET/MRI examination will be performed once for all included patients, using injected fluorocholine, with a dose of 3MBq/kg, up to 2 months before HCC treatment.
16008451|NCT02824172|Other|cast immobilization group|Patients in this group will have their knee locked with a resin going from the ankle to the top of the thigh for 4 weeks, followed by 4 weeks without cast but with rehabilitation through physiotherapy.
16008452|NCT02824172|Other|complete sport rest.|Patients included in this group will follow the current standard procedure for this disease that is to say complete sport rest during 8 weeks including rehabilitation through physiotherapy, following the exact same technic as the experimental group .
16008453|NCT02824159|Other|Blood samples for pharmacokinetics exploration|6 blood sample at regular intervals
16008454|NCT02824159|Other|Imagery|Efficacity will be assessed with 3 sessions of resonance magnetic imaging or positron emission tomography scan
16008455|NCT02824159|Other|Quality of life scale|Quality of life will be evaluated with questionaries 5 times during the study
16008456|NCT02824159|Other|Detection of adverse events|The detection will be assessed using the AMA (assistance des malades ambulatoires) system
16008457|NCT02824159|Genetic|Saliva samples|Saliva samples will be collected to explore genetic characteristics of germinal DNA (genes involved in drug pharmacokinetic)
16008458|NCT02824159|Genetic|Blood sample|A unique blood sample will be performed in order to determine characteristics of tumoral DNA (resistance to treatment mutation)
16008459|NCT02824159|Other|Biological statement|"The following parameters will be assessed :
~Complete blood count
~Hemoglobin
~Hepatic enzymes
~Creatinine clearance
~Lactate dehydrogenase rate
~Total bilirubin rate
~Cluster of differentiation 4 T lymphocytes rate
~Total gamma-globulins rate"
16008460|NCT02824159|Other|Clinical examination|"The clinical examination are composed by :
~Weigh, Height and body mass index measurement
~Clinical state of patient during examination
~Stage of the disease (OMS grade, binet classification, Ahn Arbor classification)
~Presence of B symptomatology
~Prognostic factors (Genetic, Mantle Cell Lymphoma International Prognostic Index, Follicular Lymphoma International Prognostic Index, presence of lymph nodes, other target organs ...)"
16008461|NCT02824146|Other|Lung recruitment maneuver|The lung recruitment maneuver consists in a brief and controlled increment in airways pressure (15 cmH2O of PEEP + 15 cmH2O of driving pressure) for 10 breaths.
16008462|NCT02824133|Drug|AZD4547|80 mg bd (per os)
16008463|NCT02824120|Other|Comedy|patients will watch comedy film
16008464|NCT02824120|Other|Documentary|patients will watch a documentary film
16008465|NCT02824107|Biological|blood sample|
16008466|NCT02824107|Behavioral|questionnaires for psychosocial factors|
16008467|NCT02824094|Drug|crizotinib|Crizotinib, 250 mg BID, will be administered orally on a continuous daily dosing schedule
16008468|NCT02824081|Biological|Blood sample|Blood sample in order to study inflammatory biomarkers and genetics purpose
16008469|NCT02824068|Drug|glucosidase alfa|Long-term use in an observational study of licenced drug
16008470|NCT02824055|Drug|Placebo|Participants will receive placebo matched to RO5545965 capsules orally daily in any of the three intervention period.
16008471|NCT02824055|Drug|RO5545965|Participants will receive RO5545965 5 mg capsules or RO5545965 15 mg capsules (5 mg for 3 days, 10 mg for 3 days and 15 mg for 15 days) orally daily in any of the three intervention period.
16008472|NCT02824042|Drug|Anetumab ravtansine (BAY94-9343)|Anetumab ravtansine given IV On Day 1 of each 21-day treatment cycle Part 1: Cycle 1 Day 1: 6.5 mg/kg of body weight (BW) Cycle 2 Day 1: 0.6 mg/kg BW Part 2: Cycle 1 Day 1: 6.5 mg/kg BW Cycle 2 Day 1: 6.5 mg/kg BW (planned dose) Continuous treatment: Cycles ≥3 Day 1: 6.5 mg/kg BW once every 3 weeks (Q3W)
16008473|NCT02824042|Drug|Itraconazole|Itraconazole 100 mg oral capsules given by mouth Cycle 1 (Day 18): 200 mg twice daily (BID) (Days 19 - 21): 200 mg once daily (QD) Cycle 2 (Days 1-8): 200 mg QD 12 days in total (Part 1 or Part 2)
16008474|NCT02824029|Drug|Ibrutinib|Given PO
16008475|NCT02824029|Other|Laboratory Biomarker Analysis|Correlative studies
16008476|NCT02824029|Other|Pharmacological Study|Correlative studies
16008477|NCT02824016|Biological|biological sample|T4, thyrotropic-stimulating hormone (TSH) and Thyroglobulin antibody were systematically measured
16008478|NCT02824016|Radiation|supraclavicular irradiation|Irradiation of the homolateral supraclavicular area delivering 46 Gy in 23 fractions
16008479|NCT02824003|Drug|ISIS-GCGRRx|once weekly dosing for 13 weeks
16008480|NCT02824003|Drug|Placebo|once weekly dosing for 13 weeks
16008481|NCT02823990|Biological|TG4010|Given SC
16008482|NCT02823990|Biological|Nivolumab|Given IV
16008483|NCT02823977|Drug|Ketamine|Blinded study drug administered to experimental arm
16008484|NCT02823977|Drug|Dexmedetomidine|Open-label study drug administered to both arms
16008485|NCT02823977|Drug|Normal saline|Blinded comparator administered to control arm
16008486|NCT02823964|Drug|Liprotamase|Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement
16008487|NCT02823951|Drug|Rebif|
16008488|NCT02823951|Drug|Tecfidera|
16008489|NCT02823938|Other|existing database on data collection.|This is an observational study on an existing database.
16008490|NCT02823925|Drug|Pamidronate or Zoledronate|
16008491|NCT02823912|Drug|Capsaicin|
16008492|NCT02823912|Drug|Magnesia calcinada|
16008493|NCT02823899|Biological|HL-OCV|Pharmaceutical company in Bangladesh is now producing HL-OCV, with technological support from MSD wellcome trust Hilleman pt. ltd, which meets international Good manufacturing practice( GMP) standards and WHO production guidelines.
16008494|NCT02823899|Biological|Shanchol|The vaccine is manufactured by Shantha Biotechnics in hyderabad, India and is prequalified by the WHO. Shanchol is available in a single dose. This vaccine is used as two dose regimen.
16008495|NCT02823886|Other|MRI at D7|The infarct size measured on MRI at 7 days.
16008496|NCT02823886|Biological|Blood samples|Blood samples at H0; H4; H12; H24, H48, D7 and 1 month post MI
16008497|NCT02823873|Device|Pulsewave oscillometric wrist cuff blood pressure monitor|Blood pressure monitor utilizing wrist cuff administered and measured using mobile technology.
16008498|NCT02823860|Other|Collection of biospecimens and Quality of Life (QoL) assessment|Serum, plasma, buffy coat and formalin-fixed-paraffin-embedded (FFPE). Biospecimens are collected at various stages of diagnostic and therapeutic care.All patients fill out questionnaires of Health related quality of life (QLQ-C30 + QLQ-CR29/STO22, Hospital Anxiety and Depression scale - HAD) and social-demographic survey (Medical Outcome Studies - Social Support Survey- MOS-SSS).
16008499|NCT02823847|Behavioral|Screening Interview|Participants asked about demographic information, and questions about history of tobacco, alcohol, and mouthwash use. Interview lasts about 7 minutes.
16008500|NCT02823847|Device|Carbon Monoxide Test|Carbon monoxide testing given to participants at baseline. Participants blow into a device that measures the amount of carbon monoxide in the lungs.
16008501|NCT02823847|Behavioral|Self-Help Materials|"Participants who want to stop smoking are given referral information for a tobacco cessation program at baseline.
~Participants with premalignant and malignant oral lesions [PMOL]) given printed materials and web-based programs for tobacco and alcohol cessation."
16008502|NCT02823847|Procedure|Visual Oral Screening Examination|Intraoral exam performed under incandescent (white light) conditions at baseline, and again two weeks later.
16008503|NCT02823847|Procedure|Direct Fluorescent Oral Visualization Examination|Intraoral exam performed under reduced room lighting with a handheld autofluorescence imaging device at baseline, and again two weeks later.
16008504|NCT02823847|Procedure|Oral Biopsy|Premalignant and malignant oral lesions [PMOL]) still present 2 weeks after oral exam are biopsied.
16008505|NCT02823834|Device|PROFEMUR® Gladiator Plasma Femoral Stems|THA using PROFEMUR® Gladiator Plasma stems and PROCOTYL® L Beaded Acetabular Components
16008506|NCT02823821|Other|Default dialysate sodium concentration of 137mmol/l|Default defined here as use of allocated dialysate sodium concentration for at least 90% of delivered dialysis sessions.
16008507|NCT02823821|Other|Default dialysate sodium concentration of 140mmol/l|Default defined here as use of allocated dialysate sodium concentration for at least 90% of delivered dialysis sessions.
16008508|NCT02823808|Drug|NESINA ACT TAB. 25/15mg|Alogliptin/Pioglitazone 25/15mg will be administered to the group once a day in a fixed dose on a fixed schedule for 104 week.
16008509|NCT02823808|Drug|AMARYL-M TAB. 2/500mg|Glymepiride/Metformin 2/500mg will be administered to the group once a day in a fixed dose on a fixed schedule for 104 week.
16008510|NCT02823795|Behavioral|Motivational Interviewing|Patients will get motivational interviewing sessions by a patient activation coach (medical social workers and/or nurses trained in motivational interviewing and in the intervention) in five post hospital discharge sessions (whereof one face-to-face, four by phone) aiming to increase patient motivation to become active in self-management (medication management, care plan/follow-up, symptoms/signs of worsening condition, contacts with health care provider).
16008511|NCT02823782|Other|MRI|MRI and neuropsychological assessment planned for the study for patient and volunteers
16008512|NCT02823782|Other|neuropsychological assessment|
16008513|NCT02823769|Device|SI-R21204 resin composite|Primary caries of posterior teeth will be restored using SI-R21204 resin composite. Procedures will be done under local anesthesia if necessary. The preperation and restoration of the tooth will be done according to to the guidelines for ordinary restorative techniques.
16008514|NCT02823769|Device|Nanohybrid resin composite|One of the cavities will be restored with a nanohybrid resin composite (Clearfil Majesty) as a control restoration wth ordinary restorative techniques.
16008515|NCT02823756|Procedure|Physical Therapy|Exercise, education, spinal manipulation
16008516|NCT02823743|Drug|Aspirin|Daily medication
16008517|NCT02823743|Drug|Placebo|Daily intake
16008518|NCT02823730|Other|PCI with Synergy Stent|500 patients who have received the Synergy stent. Data will be mined from the DES registry database for the identified Synergy patients at the following time points, in-hospital and then at 1 year, 2 years, 3 years, and 4 years after percutaneous coronary intervention (PCI).
16008519|NCT02823691|Drug|Lanreotide and Metformin|Lanreotide and Metformin
16008520|NCT02823678|Procedure|Pancreatectomy|Patients will undergo pancreatectomy as part of routine care for their pancreatic neoplasms.
16008521|NCT02823665|Drug|Exendin-(9-39)|A physiological study to evaluate the role of GLP-1 on glucose metabolism and insulin secretin after glucose and protein ingestion.
16008522|NCT02823665|Drug|Atropine|A physiological study to evaluate the effect of neural activation on insulin secretion and glucose metabolism.
16008523|NCT02823652|Other|Counseling|Undergo usual care
16008524|NCT02823652|Other|Genetic Counseling|Complete remote counseling
16008525|NCT02823652|Other|Genetic Testing|Undergo germline testing
16008526|NCT02823652|Other|Internet-Based Intervention|Complete on-line genetic education
16008527|NCT02823652|Other|Survey Administration|Ancillary studies
16008528|NCT02823639|Procedure|Transcranial direct current stimulation|
16008529|NCT02823626|Drug|Spironolactone and patiromer|High dose spironolactone with or without patiromer based on the patient's baseline potassium
16008530|NCT02823613|Dietary Supplement|High salt diet followed by low salt diet|High salt diet (250 mmol/day) in 5 days followed by low salt diet (60-70 mmol/day) in 5 days.
16008531|NCT02823613|Dietary Supplement|Low salt diet followed by high salt diet|Low salt diet (60-70 mmol/day) in 5 days followed by high salt diet (250 mmol/day) in 5 days.
16008532|NCT02823600|Device|RetinaVue 100 camera|Images of the subject's eye will be obtained using the RetinaVue 100 camera and uploaded to a secure network. The study doctor, a board-certified ophthalmologist, will interpret the patient images and return a diagnosis and management plan to the dialysis unit.
16008533|NCT02823587|Other|Pulmonary Rehabilitation|The exercise program will consist of an individual exercise prescription on the treadmill or bike, the initial intensity of 85% VO2max and active exercises or active-resistance for upper and lower limbs according to the capacity of each volunteer.
16008534|NCT02823587|Other|Control|No supervised exercise session, only will be informed at the beginning of the study to perform thirty minutes of physical activity of moderate intensity several days a week is associated with health benefits
16008535|NCT02823574|Biological|Nivolumab|
16008536|NCT02823574|Biological|Ipilimumab|
16008537|NCT02823574|Other|Placebo|
16008538|NCT02823561|Dietary Supplement|Garcinia mangostana|
16008539|NCT02823561|Behavioral|Control group|
16008540|NCT02823548|Drug|Droglican|Chondroitin Sulfate 1,200mg + Glucosamine Hydrochloride 1,500mg
16008541|NCT02823548|Drug|Placebo|Placebo
16008542|NCT02823535|Behavioral|Iwin: Individual Well-Being Navigator|Immediately following the baseline assessment, the Intervention Group will receive a secure link to download the IWin app. The app provides three types of integrated interventions: 1) stage-matched feedback on the participant's risk behaviors as determined via the assessments; 2) up to two in app messages a day determined by a series of algorithms that control the timing, content, and cadence of the messages; and 3) up to two prompts a week to complete stage-matched activities that foster behavior change (e.g., quizzes, calculators, guided visualizations, info-graphics, testimonials, and more).
16008543|NCT02823522|Other|Patients recruitment|Between July and November 2016, the patients included in the previous retrospective study were contacted by phone, mail and e-mail and invited to come back to the respective clinics where they had been initially diagnosed as NCWS patients: the Department of Internal Medicine of the University Hospital of Palermo and the Department of Internal Medicine of the Hospital of Sciacca (province of Agrigento).
16008544|NCT02823509|Drug|Coppertone (BAY 987517)|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation-SR15-68_R84-089)
16008545|NCT02823496|Other|Sunscreen Lotion , BAY 987521|50 μl/ cm2 of the test article is applied directly to two sites on the skin and covered with the appropriate patch. 24 hours later, the patches are removed. The test sites are lightly wiped with a dry cloth/tissue and 3μl/cm2 of test article is reapplied directly to the skin of the test site designated for irradiation, and lightly spread over the test site. 48 hours later the procedure is repeated to the same test sites. This process is repeated twice weekly for a total of six exposures. Formulation A: Y49-103, Formulation B: Y71-150.
16008546|NCT02823496|Other|Untreated skin|One site is patched without treatment as control
16008547|NCT02823483|Other|Sunscreen Lotion (BAY987521)|50 μl/cm*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each) on the lower or mid-back.Formulation A: Y49-103, Formulation B: Y71-150.
16008548|NCT02823483|Other|Untreated Skin|This site is patched without treatment as irradiated control
16008549|NCT02823470|Drug|LUM/IVA|LUM 400 mg q12h/IVA 250 mg q12h through Week 48.
16008550|NCT02823470|Device|activated smart device|
16008551|NCT02823470|Device|de-activated smart device|
16008552|NCT02823457|Behavioral|VBMI|12 week values based motivational interviewing intervention with a licensed psychologist
16008553|NCT02823444|Other|Magnetic Resonance Angiography|"Subjects who agree to participate in the study and provide written informed consent will undergo three station (abdomen/pelvis, thighs, and calves/feet) contrast and non-contrast enhanced magnetic resonance angiography of the lower extremities. Study visits may be split into two imaging sessions to decrease the time the participant is in the scanner if necessary. For image quality review, several participant may undergo only abdomen/pelvis imaging.
~Performance of the non-contrast magnetic resonance angiography requires placement of magnetic resonance imaging compatible electrocardiography leads on the patient's chest, so that the heart rate can be monitored and images can be obtained timed to each individual patient's heart beat. Electrocardiography monitoring/gating is performed routinely, and is not investigational."
16008554|NCT02823431|Drug|lidocaine gel|
16008555|NCT02823431|Other|Plain aqueous gel|
16008556|NCT02823418|Procedure|No neuraxial labor analgesia|Neuraxial analgesia will not be performed. Analgesics will be prescribed by the obstetricians according to routine practice.
16008557|NCT02823418|Procedure|Neuraxial labor analgesia|Epidural or combined spinal-epidural labor analgesia will be performed when the cervix is dilated to 1 cm or more and continued until the cervix is fully dilated to 10 cm.
16008558|NCT02823405|Drug|X4P-001|X4P-001 100 mg capsules, administered orally, continuous daily dosing
16008559|NCT02823405|Drug|Pembrolizumab|Pembrolizumab 2 mg/kg, administered by IV infusion every 3 weeks
16008560|NCT02823392|Other|DBMV|the occurrence of at least two following events which were requiring application of CPAP with opening airway maneuvers, requiring oropharyngeal airway, requiring two-person bag mask ventilation, unable to perform bag mask ventilation or presence of desaturation (SpO2 < 95%).
16008561|NCT02823379|Behavioral|Physical Activity|A Smartphone delivered physical activity program
16071161|NCT02374567|Drug|Reboxetine|
16008562|NCT02823379|Behavioral|Wellness|A Smartphone delivered wellness intervention focused on topics other than physical activity (e.g., skin care, oral health, and breast exams).
16008563|NCT02823366|Drug|Fenofibrate|
16008564|NCT02823366|Drug|UDCA|
16008565|NCT02823353|Drug|Fenofibrate|
16008566|NCT02823353|Drug|UDCA|
16008567|NCT02823340|Device|Fractional microneedle RF(United, Peninsula Medical, China)|
16008568|NCT02823327|Genetic|Laboratory Biomarker Analysis|Correlative studies
16008569|NCT02823327|Other|Medical Chart Review|Medical chart review is performed
16008570|NCT02823314|Device|Cure Tape™ covering T 7 and T 8 dermatomes|The intervention group will have to apply two strips of special hypoallergenic tape called Cure Tape™ that will have a size of 20 x 5 cm and they will have to be placed on the T7-T8 dermatome area.
16008571|NCT02823314|Device|Cure Tape™ away from dermatomes T 7 and T 8|The control group will have to apply two strips of special hypoallergenic tape called Cure Tape™ that will have a size of 5 x 4 cm and they will have to be placed near the greater trochanter area.
16008572|NCT02823301|Behavioral|VAMOS Program|Active life improving health: all participants that will be assigned to change behavior group will participate of a change behavior program, entitled VAMOS (Active Life Improving Health), for five months. The VAMOS Program is a lifestyle promotion program, that includes physical activity and healthy eating habits. The program is composed by 12 meetings (six weekly meetings and six fortnightly meetings), in group, lasting about 90 min. In each In each weekly meeting, will be discussed guidelines and strategies for physical activities practices in different domains and for adoption of a healthy diet. All aspects and strategies included in the program are based in behavior changes theories.
16008573|NCT02823288|Other|Sonke CHANGE intervention|"The Sonke CHANGE intervention is a multi-level model aimed at individual, group, community, and societal levels. Sonke's programming is comprised of three core components:
~Workshops based on the premise that deeply held gender and sexuality beliefs can be critically examined and transformed in a reflective group setting. Workshops aim to challenge inequitable and harmful ideas about manhood and encourage men to take action to promote equality.
~Community Action Teams (CATs) are comprised of interested men and women, who mobilize on a voluntary basis around issues in their neighborhoods. Methods include ambush theatre, murals painting, door to door campaigns, street soccer festivals, rallies, and community dialogues.
~Local Advocacy is undertaken by CAT members, who aim to hold government and other duty bearers to account for VAWG prevention. CAT members join local community structures to advance community education and local government accountability."
16008574|NCT02823275|Other|Functional mobilisation|functional mobilisation
16008575|NCT02823275|Other|Short term plaster cast fixation|2 weeks cast immobilisation
16008576|NCT02823262|Other|Breast Cancer Treatment Decision Aid for women 70+|We developed a decision aid on breast cancer treatment for women 70 years or older newly diagnosed with estrogen receptor positive (ER+), clinically lymph node negative (LN-), HER2 negative (HER2-), breast cancers that are 3 centimeters or less. The DA was written using low literacy principles and provides information on the benefits and risks of mastectomy vs. breast conserving surgery (BCS), radiotherapy after BCS, and of hormonal therapies (e.g., anastrozole). It also considers the impact of competing health issues on older women's treatment choices.
16008577|NCT02823262|Other|Usual Care|
16008578|NCT02823249|Dietary Supplement|1.56 g L-Tryptophan|
16008579|NCT02823249|Dietary Supplement|1.56 g L-Leucine|
16008580|NCT02823249|Dietary Supplement|50 g Xylitol|
16008581|NCT02823249|Dietary Supplement|75 g Erythritol|
16008582|NCT02823249|Dietary Supplement|75 g Glucose|
16008583|NCT02823249|Dietary Supplement|Tap water|
16008584|NCT02823249|Dietary Supplement|Mixed liquid meal (Ensure Plus®; 17% protein, 29% fat and 54% carbohydrate)|
16008585|NCT02823249|Device|Nasogastric Tube|
16008586|NCT02823236|Drug|Topical Pirfenidone|Pirfenidone 8% gel will be applied three times per day during 6 months in the surface of the keloid scar.
16008587|NCT02823236|Drug|Triamcinolone + Pirfenidone|Triamcinolone will be injected in the keloid scar 4 mg/cm2 every 4 weeks for 6 months. And pirfenidone 8% gel will be applied three times per day during 6 months in the surface of the keloid scar.
16008588|NCT02823236|Drug|Intralesional Triamcinolone|Triamcinolone will be injected in the keloid scar 4 mg/cm2 every 4 weeks for 6 months.
16008589|NCT02823223|Device|Zephyr endobronchial valve placement|Patients will have ELVR (Endoscopic Lung Volume Reduction) with Zephyr valve inserted into the target lobe of the lung with the aim of complete lobar exclusion.
16008590|NCT02823197|Other|Active transport lesson|
16008591|NCT02823197|Other|Active transport lesson and Facebook group|
16008592|NCT02823184|Biological|RNA sample of total leukocytes before start of treatment|RNA sample of total leukocytes before start of treatment
16008593|NCT02823171|Drug|Treatment A: 400 mg Pacritinib P3CT|400-mg oral dose of pacritinib P3CT (reference) formulation capsules
16008594|NCT02823171|Drug|Treatment B: 400 mg of pacritinib FMI|400-mg oral dose of pacritinib FMI (test) formulation capsules
16008595|NCT02823158|Procedure|Deep brain stimulation (DBS) of Globus Pallidus internus (GPi) and Best medical treatment (BMT)|"Patients in the GPi group will be implanted with DBS-electrodes within 6 weeks after randomisation. The stimulation parameters and the medical treatment are adjusted for optimal control of motor and non-motor signs and symptoms according to published guidelines using a specified algorithm. The stimulation parameters are recorded at the beginning and at the end of each post-surgical assessment.
~Best medical treatment is applied in combination with GPi-DBS."
16008596|NCT02823158|Procedure|Best medical treatment|Patients will receive optimized medical treatment according to published evidence based guidelines.
16008597|NCT02823145|Drug|ZX008 (Fenfluramine Hydrochloride)|
16008598|NCT02823132|Biological|blood sample|
16008599|NCT02823119|Device|Mini-hysteroscopy|Hysteroscopy will be performed with the use of the non-touch technique (vaginoscopic approach). The investigators will use a rigid 2.7-mm hysteroscope with a 30° forward oblique lens and an outer sheath diameter of 3.3 mm. All of the procedures will be diagnostic.
16008600|NCT02823119|Device|Conventional Office Hysteroscopy|. Hysteroscopy will be performed with the use of the non-touch technique (vaginoscopic approach). The investigators will use a rigid 2.9-mm hysteroscope with a 30° forward oblique lens and an outer sheath diameter of 5 mm. All of the procedures will be diagnostic.
16009020|NCT02819843|Radiation|Hypofractionated Radiotherapy|
16008603|NCT02823080|Drug|Cetrorelix|study group received 3-day Cetrorelix Acetate sc injection (0.25 mg/day) started on Day-0. Serum E2, pain scores and MOD were checked daily. Hematocrit value (Ht%), total leucocytic count (TLC), gastrointestinal (GI) manifestations and ascites control (24 patients) did not receive Cetrorelix Acetate. Grading were re-evaluated on Day-3, 6 and 8.
16008604|NCT02823067|Other|Blood sample|One extra blood sample of 10 ml will be taken during a routine venapunction for immunoserology testing.
16008605|NCT02823054|Device|EZ-Blocker|the Blocker group, the EZ-Blocker will be set up after anesthesia induction and standard orotracheal intubation to allow lung exclusion during homolateral internal thoracic artery sampling, and thus a one-lung ventilation. This material will be removed at the end of surgical surgery.
16008606|NCT02823041|Behavioral|Cognitive Training|24 weeks of systematic computerized cognitive training, 4 hours per week. The first 12 weeks involves neurocognitive training, using auditory training exercises from Posit Science Brain HQ. The 2nd 12 weeks involves social cognitive training, using the Posit Science SocialVille modules. A weekly one-hour Bridging Skills Group is designed to aid generalization of training to everyday life situations.
16008607|NCT02823041|Behavioral|Aerobic Exercise|Aerobic exercise occurs as two 45-minute sessions at the clinic and two 30-minute sessions at home weekly. Exercise involves an adaptation of interval training, including a variety of calisthenics that can be done without specialized equipment. Intensity of aerobic exercise is tailored to maintain an individualized target heart rate zone and is monitored by a heart rate recorder.
16008608|NCT02823041|Behavioral|Case management and supportive psychotherapy|An individual therapist will provide weekly case management and therapy targeting the individual psychological problems and everyday functioning needs of the patient
16008609|NCT02823041|Behavioral|Individual Placement and Support|An job/school specialist will use the Individual Placement and Support model to help participants return to school or work and provide ongoing outreach support.
16008610|NCT02823028|Drug|NRT|8-weeks of study provided NRT patch, and 8-weeks of study provided NRT gum of varying strengths or 8-weeks of study provided NRT lozenges, depending on patient level of nicotine dependence.
16008611|NCT02823028|Behavioral|Web Guide|"A website that will provide participants with access to an evidence-based set of base treatment materials in one central location. The site will include information on the proper use of nicotine patches, gum, lozenges, and it will have a direct link for participants to access the NCI's Smokefree.gov Quit Guide. The website will remind participants about quit dates and send alerts via email to participants to complete the appropriate NCI Quit Guide modules."
16008612|NCT02823028|Behavioral|Tweet2Quit|"A fully automated, 90-day quit smoking intervention that provides an online, peer-to-peer support group for quitting and uses twice-daily automessages to encourage and direct the peer-to-peer exchanges. Each group will consist of 12 buddy pairs (matched on key demographics) that will be introduced via automated texts. The program will generate twice-daily programmed contacts (e.g., what benefits do you hope to get from quitting smoking?). Automated pattern detection software will identify and address any problematic low tweeting within a group."
16008613|NCT02823002|Procedure|Slow, Room Temperature Injection|The room temperature local anesthetic agent will be administered by slow infiltration.
16008614|NCT02823002|Procedure|Rapid, Room Temperature Injection|The room temperature local anesthetic agent will be administered by rapid infiltration.
16008615|NCT02823002|Procedure|Slow, Warm Temperature Injection|The warmed local anesthetic agent will be administered by slow infiltration.
16008616|NCT02823002|Procedure|Rapid, Warm Temperature Injection|The warmed local anesthetic agent will be administered by rapid infiltration.
16008617|NCT02823002|Procedure|Buffered Injection|One side of the body will be randomized to receive an injection of the buffered agent, while the contralateral side will be assigned to receive an injection of the unbuffered anesthetic agent.
16008618|NCT02823002|Procedure|Non-Buffered Injection|One side of the body will be randomized to receive an injection of the buffered agent, while the contralateral side will be assigned to receive an injection of the unbuffered anesthetic agent.
16008619|NCT02823002|Drug|Lidocaine|Injectable lidocaine solution (Lidocaine Hydrochloride and Epinephrine)
16008620|NCT02823002|Drug|Buffer|Sodium Bicarbonate
16008621|NCT02822989|Device|Vagus nerve stimulation|Patients will receive transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. The device is a handheld electrical pulse generator and a pair of electrodes to be placed at the ear for stimulation. The specific target at the ear will be the auricular branch of the vagus nerve which innervates the skin of the ear canal. Electrodes will be placed near/at the entrance to the canal of the ear to provide stimulation to the auricular branch.
16008622|NCT02822989|Device|Sham vagus nerve stimulation|Patients will receive sham transcutaneous stimulation of the auricular branch of the left vagus nerve for 5 minutes daily for 4 consecutive days. Sham stimulation will be performed in the identical manner as true transcutaneous stimulation except that the patient will not receive electrical stimulation of the vagus nerve.
16008623|NCT02822950|Drug|Ceftazidime/avibactam|Ceftazadime/avibactam dosing in ICU patients
16008624|NCT02822937|Drug|Methylphenidate|Methylphenidate is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control. Methylphenidate is used to treat attention deficit disorder (ADD), attention deficit hyperactivity disorder (ADHD), and narcolepsy.
16008625|NCT02822937|Drug|Triazolam|Triazolam is a benzodiazepine similar to Valium. Triazolam affects chemicals in the brain that may become unbalanced and cause sleep problems (insomnia). Triazolam is used to treat insomnia (trouble falling or staying asleep).
16008626|NCT02822937|Other|Project: EVO|Project: EVO Monitor was designed to incorporate a proprietary multi-tasking assessment into a state-of-the-art mobile video game-like platform, which deploys modern videogame graphics, engaging reward loops, and real-time adaptive mechanics to dynamically personalize difficulty in order to assess the user's ability.
16008627|NCT02822937|Drug|Placebo|Sugar pill
16008662|NCT02822651|Biological|Blood sampling|Patients will have a blood sampling at inclusion to measure vitamin D blood concentration.
16008663|NCT02822651|Other|self-administered questionnaire|Patients will fill a self-administered questionnaire the day of inclusion
16008664|NCT02822638|Other|STEMI PATIENT Cohort|PCI
16008665|NCT02822625|Drug|QUTENZA®|
16008666|NCT02822625|Other|hypnotic message|
16008667|NCT02822625|Other|music therapy|
16071162|NCT02374567|Drug|Duloxetine|
16008628|NCT02822924|Procedure|Prostate artery embolization (PAE)|Right femoral arterial puncture is performed under local anesthesia. The blood supply to the prostate is mapped by angiography of the iliac vessels and the prostate arteries. Microcatheters are used for super-selective catheterization of the right and left inferior vesicle arteries. Embolization is performed with a microcatheter to deliver microspheres of 300 micron diameter. The microsphere mixture is slowly injected under fluoroscopic guidance. The endpoint of embolization is flow stasis in the prostatic vessels with prostatic gland opacification, without reflux of the mixture to undesired arteries.
16008629|NCT02822911|Behavioral|Alcohol Used Disorders Identification Test (AUDIT C)|"The Audit-C questionnaire is a three item alcohol screen that can help identify persons who are hazardous drinkers or have active alcohol abuse disorders (including alcohol abuse or dependence). The AUDIT-C is a modified version of the 10 question AUDIT instrument.
~Score from 0 to 12. Each Audit-C question has a 5 answer choice, allotted points are from 0 to 4 points. In men, a score of 4 is considered as positive, optimal for identifying hazardous users or active alcohol abuse disorders. The same for 3 points in women."
16008630|NCT02822911|Procedure|Carbohydrate deficient transferrin|Blood sample to collect carbohydrate deficient transferrin (CDT) only if the Alcohol Used Disorders Identification Test (AUDIT C) reports at least 1 point.
16008631|NCT02822911|Procedure|Gamma glutamyl transpeptidase|Results of Gamma glutamyl transpeptidase (GGT) performed as routine practice collected only if the Alcohol Used Disorders Identification Test (AUDIT C) reaches at least 1 point.
16008632|NCT02822911|Procedure|Mean Corpuscular Volume|Results of Mean Corpuscular Volume (MCV) performed as routine practice collected only if the Alcohol Used Disorders Identification Test (AUDIT C) reports at least 1 point.
16008633|NCT02822898|Drug|NaCl 0.9% in Glucose 5% with 40mEq Potassium|NaCl 0.9% in Glucose 5% with 40mEq Potassium, administered at 25 mL/kg IBW/h for 48h
16008634|NCT02822898|Drug|Glucion 5%|Glucion 5% (premixed solution containing 54 mmol/L sodium and 26 mmol/L potassium amongst others), administered at 25 mL/kg IBW/h for 48h
16008635|NCT02822885|Radiation|Ultrasonography|Ultrasonographic assessment of the thickness of the endometrium of the uterus and transvaginal color Doppler ultrasonography for measurements of Pulsatility index and resistance indices of uterine arteries and spiral arteries
16008636|NCT02822859|Device|Wright nebulizer|Roxon Medi-Tech, Montreal, QC, Canada
16008637|NCT02822859|Device|Bennett-Twin nebulizer|Puritan Bennett Corp., Carlsbad, CA, USA
16008638|NCT02822859|Device|Aeroneb Solo|Aerogen Ltd., Galway, Ireland
16008639|NCT02822846|Other|lung ultrasound|
16008640|NCT02822833|Procedure|Sentinel lymph node mapping|Before laparoscopic hysterectomy and lymphadenectomy procedure for endometrial cancer, Indocyanine green solution will be injected through cervix. Then the surgeon will look for sentinel lymph nodes under fluorescence visualization.
16008641|NCT02822820|Device|Ligasure-Covidien|Vessel sealing device Ligasure-Covidien used during laparoscopic hysterectomy and pelvic lymphadenectomy
16008642|NCT02822820|Device|RoBi forceps-Karl Storz|Vessel sealing device RoBi forceps-Karl Storz used during laparoscopic hysterectomy and pelvic lymphadenectomy
16008643|NCT02822807|Biological|Blood sampling|
16008644|NCT02822794|Drug|SOF/VEL|400/100 mg tablet administered orally once daily
16008645|NCT02822794|Drug|RBV|Capsules administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, > 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)
16008646|NCT02822781|Other|No intervention|There is no intervention. The patients will receive common questionnaire usually used by doctors (SNOT 22). Some Data to describe the population are collected then.
16008647|NCT02822768|Procedure|Packing|The patient will receive packing as part of their wound care
16008648|NCT02822768|Other|No packing|The patient will not receive packing as part of their wound care
16008649|NCT02822755|Other|Home Exercise Program and Adherence Logs|Both groups will receive physical therapy prescribed home exercises and be asked to record adherence to their program on an exercise log.
16008650|NCT02822742|Drug|DE-117 ophthalmic solution|
16008651|NCT02822742|Drug|Latanoprost ophthalmic solution 0.005%|
16008652|NCT02822729|Drug|DE-117 ophthalmic solution|
16008653|NCT02822729|Drug|Timolol ophthalmic solution|
16008654|NCT02822716|Procedure|IRE treatment|The treatment procedure is carried out percutaneously under ultrasound or CT guidance, or using laparoscopic or laparotomy approach when the lesion is close to hollow viscera or abdominal wall, with the patient under general anaesthesia. Insulated needle electrodes, will be placed in the treatment areas under ultrasound or CT guidance. The tumor lesion is identified, measured, and located by ultrasound or CT. Electrical current is administered in pulses with electrocardiographic synchronization to reduce the risk of cardiac arrhythmia.
16008655|NCT02822716|Device|Ultrasound|
16008656|NCT02822703|Device|rTMS Active 20Hz|Active stimulation will be delivered with 70mm Double Air Film Coils. Participants will attend eight 20Hz sessions within two weeks of the scheduled quit date. Participants will receive 20Hz at 110% of the MT for 1 second, less than the limits indicated in the guidelines. These stimulation parameters have been utilized with no serious adverse events in previous studies to decrease delay discounting among smokers and non-smokers. These parameters are similar to or less intense than those utilized in other smoking cessation studies. All participants will receive rTMS over the same area of the DLPFC (6cm anterior to the MT area) while reading relapse prevention booklets supervised by the study coordinator.
16008657|NCT02822703|Device|rTMS Sham|The sham stimulation uses a similar 70mm Double Air Film Coil to look and sound like the active coil, but the magnetic field produced by the sham coil is markedly attenuated (only 5% of stimulator output setting: that is 2.25% of the maximum stimulator output (5% of 45% = 2.25%) and biologically inactive. Participants in this condition will attend eight sham sessions within two weeks of their scheduled quit date. During these sessions, they will also read relapse prevention booklets supervised by the study coordinator. The sham coil is not intended to and does not produce a stimulation effect so there is no proposed biologic mechanism of action.
16008658|NCT02822690|Other|Hospice care at UMCG|introduction of hospice care facilities on the wards at the UMCG
16008659|NCT02822664|Behavioral|Pedophiles patients|cerebral MRI and/or cerebral PET imaging
16008660|NCT02822664|Behavioral|Healthy subjects|cerebral MRI and/or cerebral PET imaging
16008661|NCT02822664|Device|PET/MRI|
16009636|NCT02815319|Drug|Dexamethasone|Steroid prophylaxis
16008668|NCT02822612|Device|Binocular OCT prototype|Testing will begin using a prototype binocular OCT system. Subjects will undergo the full suite of diagnostic assessments offered by the system at that time (i.e., visual acuity, ophthalmic history, pupillometry, ocular motility, perimetry, anterior segment and posterior segment OCT imaging).
16008669|NCT02822599|Drug|RiaStAP|To decrease post-operative bleeding volume.
16008670|NCT02822599|Drug|Saline|Placebo consisting of normal saline 0.9%
16008671|NCT02822586|Radiation|TSEB Therapy|TSEB is a type of radiation treatment in which the skin over the whole body is treated with electron radiation beams. All participants will receive the same standard TSEB dose and treatment schedule. During TSEB, patients are treated in a standing position on a rotating platform.
16008672|NCT02822586|Drug|Brentuximab vedotin|An antibody-drug conjugate (ADC) that targets CD30. A standard dose of brentuximab vedotin will be administered to all patients by intravenous infusion 3 weeks prior to initiation of TSEB and then every 3 weeks for 3 cycles.
16008673|NCT02822573|Drug|Donepezil 5 mg|Participants will be asked to take one 5 mg tablet of donepezil daily for 6 weeks followed by two 5mg tablets daily for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period.
16008674|NCT02822573|Drug|Placebo|Participants will be asked to take one tablet of matching placebo daily for 6 weeks followed by two tablets daily for 18 weeks. After 24 weeks, participants will begin a 12 week wash-out period.
16008675|NCT02822560|Device|pEVAR|percutaneous femoral access using a suture-mediated closure device
16008676|NCT02822560|Procedure|open femoral access|cutdown to femoral artery and surgical closure
16008677|NCT02822547|Drug|Peginterferon alfa-2a|Patients will receive Peginterferon alfa-2a according to the standard medical practice
16008678|NCT02822534|Drug|SP2086|the study has 3 doses groups and the 24 subjects were administrated SP2086 50mg,100mg,200mg respectively.
16008679|NCT02822521|Other|Mobile Application|A mobile health application that asks daily questions about participants' pain, function, and disease activity.
16008680|NCT02822521|Other|Population Management System|Study staff will act as care managers behind a web-based dashboard to monitor participants' responses to the daily questions on the mobile application and connect them with their HCPs.
16008681|NCT02822508|Drug|BLI801 Laxative|BLI801 oral laxative
16008682|NCT02822508|Drug|BLI801 Placebo|BLI801 oral laxative placebo
16008683|NCT02822495|Biological|tabelecleucel|Tabelecleucel is being investigated as an off-the-shelf, allogeneic T-cell immunotherapy for the treatment of EBV+ malignancies and diseases.
16008684|NCT02822482|Drug|Copanlisib|Copanlisib will be given at Day 1, Day 8 and Day 15 (1 cycle = 28 days), administered intravenously over 60 minutes, in association with Cetuximab.
16008685|NCT02822482|Drug|Cetuximab|Cetuximab will be given weekly at Day 1, Day 8, Day 15 and Day 22 (1 cycle = 28 days), administered intravenously over 120 minutes (Cycle 1 Day 1) or 60 minutes (subsequent infusions), in association with Copanlisib.
16008686|NCT02822469|Other|Manual Therapy Treatment|"Treatment starts with 10 deep breathing movements for global relaxation. The anterior and posterior neck muscles, shoulder girdle and subdiaphragmatic will be addressed with myofascial techniques repeated 10 times in each stroke. The cervical spine will be pulled in the longitudinal direction. The draw will be held 1 time, lasting 1 minute. The thoracic region will receive mobilization technique in the anteroposterior direction,10 repeated movements involving all thoracic segment.
~The treatment will be applied previously trained therapists, 4 weeks, 2 times a week, totaling eight sessions. The treatment time per session is about 25 minutes."
16008687|NCT02822469|Device|Placebo Ultrasound|A detuned pulsed ultrasound will be applied to regions of the muscles around the shoulder girdle and anterior posterior cervical, for 25 minutes (2.5 minutes in each zone ). The device will be used with the internal cables disconnected for the placebo effect . However, you can handle it and adjust the doses and alarms as it is connected in order to simulate clinical practice and increase the credibility of the use of this device in the voluntary . The placebo treatment will be applied by previously trained therapists. Treatment will have 4 weeks, 2 times a week, totaling eight sessions.
16008688|NCT02822456|Procedure|VFSS|VFSS using assignment of tube type among the interventions such as individual 3D printed guiding tube, traditional IOE tube, levin tube
16008689|NCT02822443|Behavioral|Psychological therapy (PT) as TAU with integrated emotion focused components (TAU - EFT)|25 (+/- 3) weekly sessions and up to three booster sessions of face-to-face outpatient psychotherapy; psychological therapy with focus on emotion-focused interventions.
16008690|NCT02822443|Behavioral|Psychological therapy (PT) as TAU with focus on self-regulation (TAU - SR)|25 (+/- 3) weekly sessions and up to three booster sessions of face-to-face outpatient psychotherapy; psychological therapy with focus on self-regulation without emotion-focused interventions
16008691|NCT02822430|Other|Pain scales|"Visual analogic scale of pain
~Pain behaviour scale
~Short-FormHealth Survey (SF-36)
~Clinical Global impression
~Mini International Neuropsychiatric Interview (MINI)"
16008692|NCT02822404|Dietary Supplement|Urinary and blood sample for Cystatine dosage|Urinary and blood cystatin C are sampled in patient with nephrotoxic risks before the treatment beginning, after the first course of chemotherapy, in the middle and at the end of the treatment. A follow up assessment is also required at 2 and 5 years. The cystatin C measurements are compared to traditional nephrology markers. Their sampling requires additional blood and urinary collection but involve minimal risks for patient.
16008693|NCT02822391|Other|observation|
16008694|NCT02822378|Dietary Supplement|Dried Plum|Participants randomized to the 50g dried plum group will consume 6 dried plums per day for the duration of the 52 week intervention. Participants randomized to the 100g dried plum group will consume 12 dried plums per day for the duration of the 52 week intervention.
16008695|NCT02822378|Dietary Supplement|Calcium supplement|All participants will consume calcium supplements for the duration of baseline and intervention.
16008696|NCT02822378|Dietary Supplement|Vitamin D supplement|All participants will consume vitamin D supplements for the duration of baseline and intervention.
16008697|NCT02822365|Procedure|Computed Tomography|Undergo PET/CT scan as clinically indicated (Note: CT is for attenuation correction and not for diagnostic purposes).
16008698|NCT02822365|Device|Imaging Phantoms|Undergo limited field of view PET scan with the Pocket Phantom placed nearby to assist in scanner calibration. No additional PET tracer will be used.
16008699|NCT02822365|Procedure|Positron Emission Tomography|Undergo PET/CT scan as clinically indicated.
16009678|NCT02814968|Drug|Enzalutamide|
16008701|NCT02822339|Drug|BAY987517|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z12-030)
16008702|NCT02822326|Biological|CD19-CAR-T2 Cells|
16008703|NCT02822313|Drug|Coppertone (BAY987518)|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation: SR15-76_V27-006)
16008704|NCT02822300|Drug|Coppertone (BAY987517)|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation: SR15-74_R84-086)
16008705|NCT02822287|Drug|Acetylcystine|Clear oral solution containing 2% acetylcysteine (g/mL) in a 100 mL amber glass bottle.
16008706|NCT02822274|Drug|Coppertone (BAY987517)|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation: SR15-70_R84-064)
16008707|NCT02822261|Drug|Coppertone (BAY987516)|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation: SR15-66_R84-088)
16008708|NCT02822248|Drug|Coppertone (BAY987516)|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation: SR15-64-R84-070)
16008709|NCT02822235|Other|No Intervention|
16008710|NCT02822222|Drug|Magnesium citrate, tribasic anhydrous soft gelatin capsule|110 mg elemental magnesium/capsule
16008711|NCT02822222|Drug|Placebo soft gelatin capsule|0 mg elemental magnesium/capsule
16008712|NCT02822209|Behavioral|EORTC QLQ-C30|Questionnaire submitted at the beginning of the study. Then three more times : 3, 6 and 12 months after the start of anti-cancer therapy. The questionnaire can also be completed before the 12th month: when the care program is about to end
16008713|NCT02822209|Behavioral|Satisfaction questionnaire - patient|The patient will fill in a satisfaction questionnaire three times : around the third, the sixth and the twelfth month after they started an anti-cancer therapy.
16008714|NCT02822209|Behavioral|Satisfaction questionnaire - general practitioner or home nurse|The general practitioner or the nurse in charge of the patient at home will fill in a satisfaction questionnaire six months after the patient started an anti-cancer therapy.
16008715|NCT02822209|Behavioral|EORTC QLQ-LC13|Questionnaire submitted at the beginning of the study. Then three more times : 3, 6 and 12 months after the start of anti-cancer therapy. The questionnaire can also be completed before the 12th month: when the care program is about to end
16008716|NCT02822196|Drug|Lidocaine|Local Anesthesia using 1% Lidocaine
16008717|NCT02822196|Drug|Bupivacaine|Local Anesthesia using 0.25% Bupivacaine
16008718|NCT02822183|Other|Online Survey|
16008719|NCT02822170|Other|IV amino acids and in-bed cycle ergometry|IV amino acids and in-bed cycle ergometry
16008720|NCT02822157|Drug|Olaparib|
16008721|NCT02822157|Drug|carboplatin + gemcitabine or carboplatin + paclitaxel or carboplatin + liposomal doxorubicin or liposomal doxorubicin 4-weekly or topotecan or paclitaxel weekly|physician's choice chemotherapy
16008722|NCT02822144|Drug|Etomidate|
16008723|NCT02822144|Drug|Succinylcholine|
16008724|NCT02822144|Drug|Propofol|
16008725|NCT02822144|Drug|Remifentanil|
16008726|NCT02822144|Drug|Lidocaine|
16008727|NCT02822131|Dietary Supplement|sodium phosphate|
16008728|NCT02822131|Drug|sevelamer, sodium bicarbonate, sodium chloride|
16008729|NCT02822118|Drug|Chang'an I Recipe|Patients in this group were administered the Chang'an I Recipe, 150ml/bag, 3 times/day for 8 weeks.
16008730|NCT02822118|Drug|Placebo|Patients in this group were administered the placebo, 150ml/bag, times/day for 8 weeks.
16008731|NCT02822105|Biological|the H3N2 M2SR monovalent influenza vaccine|The H3N2 Bris10 M2SR influenza vaccine candidate (Bris10 M2SR) is formulated to contain different levels of an M2-deleted non-replicating influenza virus expressing the HA and NA genes of influenza strain A/Brisbane/10/2007.
16008732|NCT02822105|Other|Placebo|saline
16008733|NCT02822092|Drug|Risperidone or Aripiprazole (patients only)|Inpatients deemed eligible for the study, we be put on open-label risperidone
16008734|NCT02822066|Procedure|Electroporation|Effectivity and safety of irreversible electroporation for refractory neoplasms in liver and pancreas
16008735|NCT02822053|Procedure|US-guided laser ablation for refractory neoplasms|
16008736|NCT02822040|Other|Intraoral Scan|All patients will have an intraoral scan performed for measurements to be taken on.
16008737|NCT02822027|Drug|human gamma globulin|human gamma globulin for preterm infants with encephalopathy of prematurities
16008738|NCT02822027|Drug|non-human gamma globulin|Non-human gamma globulin for preterm infants with encephalopathy of prematurities
16008739|NCT02822014|Other|FDG-PET/CT|We performed baseline FDG-PET/CT, another FDG-PET/CT after 2 months of TB treatment and a PET/CT at the end of treatment in 18 HIV/TB patients.
16008740|NCT02821988|Device|External fetal monitor for Nonstress test|
16008741|NCT02821988|Device|Ultrasonography for Biophysical profile|
16008742|NCT02821975|Other|Cognitive computer training|COGNIFIT is cognitive computer training. Its purpose is to improve cognitive function and is designed to accommodate each individual's cognitive strengths and weaknesses. The cognitive computer training last three months and must be done three times a week, in session lasting 10-20 minutes.
16008743|NCT02821962|Behavioral|Sedentary prompts from a VTAP device|
16008744|NCT02821949|Biological|PCT dosage|When connecting chemotherapy products, a PCT dosage will be made. The results of dosage won't be communicated to the clinician responsible for the patient. Patient's care will then be identical to any other chemotherapy treated patient
16008745|NCT02821936|Procedure|Parametric Imaging|2 parametric PET (one at the inclusion and one at 42 gray of the beginning of radiotherapy)
16008746|NCT02821923|Dietary Supplement|E967-Xylitol|24g xylitol/d
16008747|NCT02821923|Dietary Supplement|E968-Erythritol|36g erythritol/d
16008748|NCT02821910|Drug|High dose FDC Empagliflozin/Linagliptin/Metformin XR, fed|High dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet
16008749|NCT02821910|Drug|1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR|1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets
16008935|NCT02820545|Other|Sociological interview|A sociological interview will be performed with each patient by a sociologist, during their hospital stay
16008750|NCT02821910|Drug|High dose FDC Empagliflozin/Linagliptin/Metformin XR, fasted|High dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet
16008751|NCT02821910|Drug|1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR|1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets
16008752|NCT02821910|Drug|Low dose FDC Empagliflozin/Linagliptin/Metformin XR, fed|Low dose Empagliflozin/Linagliptin/Metformin extended release (XR) fixed dose combination (FDC) tablet
16008753|NCT02821910|Drug|1 tab Empagliflozin +1 tab Linagliptin +2 tabs Metformin XR|1x Empagliflozin + 1x Linagliptin + 2x Metformin extended release (XR) tablets
16008754|NCT02821897|Procedure|Target-controlled intravenous anaesthesia|
16008755|NCT02821897|Procedure|Total anaesthesia|
16008756|NCT02821884|Device|Combination of tDCS and NMES|Both tDCS and NMES conduct simultaneously for 30 minutes. The anodal electrode of tDCS is placed on the scalp site corresponding to primary motor cortex (M1) of the hemisphere affected by stroke. The cathodal electrode of tDCS is placed on the scalp site corresponding to unaffected primary motor cortex. The current is initially increased in a ramp-like fashion over 30 seconds until reaching 2 mA and is decreased ramp-like fashion over 30 seconds until reaching 0 mA. The NMES electrodes are placed over the following muscle: extensor digitorum communis, extensor carpi radialis to produce wrist and hand extension. The settings for the NMES is frequency at 50 Hz, pulse width of 200μs,duty cycle of 10 seconds on and 10 seconds off,current amplitude is adjusted to patients comfort (10-20mA).
16008757|NCT02821884|Device|Combination of tDCS and sham NMES|Both tDCS and sham NMES conduct simultaneously for 30 minutes. The anodal electrode of tDCS is placed on the scalp site corresponding to primary motor cortex (M1) of the hemisphere affected by stroke. The cathodal electrode of tDCS is placed on the scalp site corresponding to unaffected primary motor cortex. The current is initially increased in a ramp-like fashion over 30 seconds until reaching 2 mA and is decreased ramp-like fashion over 30 seconds until reaching 0 mA. Sham NMES electrodes are placed away from all extensor digitorum communis, extensor carpi radialis motor points, and the patients receive cutaneous stimulation just above the sensory threshold without motor activation(wrist extension).
16008758|NCT02821884|Device|Combination of sham tDCS and sham NMES|Both sham tDCS and sham NMES conduct simultaneously for 30 minutes. Sham tDCS electrodes are placed in the same position on patients receiving the sham stimulation. Just like during real tDCS, stimulation is started in a ramp-like fashion but fade out slowly after 30 seconds. Sham NMES electrodes are placed away from all extensor digitorum communis, extensor carpi radialis motor points, and the patients receive cutaneous stimulation just above the sensory threshold without motor activation(wrist extension).
16008759|NCT02821871|Drug|SP2086|
16008760|NCT02821871|Dietary Supplement|high fat diet|
16008761|NCT02821858|Drug|Odalasvir (ODV)|ODV 50 mg (1 tablet) in Treatment A, 100 mg (2 tablets of 50 mg) in Treatment B and 300 mg (6 tablets of 50 mg) in Treatment C.
16008762|NCT02821858|Drug|AL-335|AL-335 400 mg (1 tablet) in Treatment D, 800 mg (2 tablets of 400 mg) in Treatment E and 1200 mg (3 tablets of 400 mg) in Treatment F.
16008763|NCT02821858|Drug|Placebo|Matching placebo will be administered.
16008764|NCT02821845|Behavioral|Untrained and Trained SCI Hip or Knee|Individuals with SCI will perform downhill walking training 3 times a week for 12 wks with a 4 wk follow-up period. This intervention will be delivered by trained therapists. In order to focus on rehabilitation of hip control or knee control, members of this group will be trained at slow to moderate gait speeds,
16008771|NCT02821819|Other|Random start ovarian stimulation|Egg-donors will start ovarian stimulation randomly at different moments throughout the menstrual cycle.
16008772|NCT02821819|Drug|Gonadotrophins|Urinary FSH 150-225 IU/d
16008773|NCT02821819|Drug|GnRH antagonist|Cetrorelix acetate 0,25 mg/d starting five days after ovarian stimulation
16008774|NCT02821819|Drug|GnRH agonist|GnRH agonist triggering with triptorelin 0,2 mg for final follicular maturation.
16008775|NCT02821793|Other|Consultation, evaluation questionnaire|Consultation, evaluation questionnaire
16008776|NCT02821793|Other|Geriatric consultation, evaluation questionnaire|Geriatric consultation, evaluation questionnaire
16008777|NCT02821754|Drug|Durvalumab|Flat dose of 1500 mg every 4 weeks.
16008778|NCT02821754|Drug|Tremelimumab|Flat dose of 75 mg every 4 weeks for up to 4 doses.
16008779|NCT02821754|Procedure|TACE|TACE will be performed on Day 36 (+/-96hrs).
16008780|NCT02821754|Procedure|RFA|RFA will be performed on Day 36 (+/-96hrs).
16008781|NCT02821754|Procedure|Cryoablation|Cryoablation will be performed on Day 36 (+/-96hrs).
16008782|NCT02821741|Device|The Twin Stim Plus, 3rd Edition|Mild transcutaneous electrical stimulation will be applied to the cymba conchae of the left ear on day 1 and the left earlobe on day 2 (or vice versa) using a commercially available TENS unit (transcutaneous electrical nerve stimulator) attached to a pair of silver electrodes.
16008783|NCT02821741|Device|Medoc Pathway System|Device used to apply Thermal stimulation to both arms.
16008784|NCT02821728|Dietary Supplement|Dietary intervention|Participants in this group will consume three portions of broccoli and stilton soup per week for a minimum of four weeks before their scheduled template prostate biopsy. The soup will be made with a specially cultivated broccoli known as Beneforte, which contains an enhanced dose of a substance called glucoraphanin.
16008785|NCT02821728|Other|Normal diet|Participants in this group will continue with their normal diet up until the day of their scheduled template prostate biopsy.
16008786|NCT02821715|Drug|Active comparator: Modafinil + placebo|
16008787|NCT02821715|Drug|THN102 300/3|
16008788|NCT02821715|Drug|THN102 300/27|
16008789|NCT02821702|Device|Vaginal ultrasound|
16008790|NCT02821702|Biological|Blood sample|
16009018|NCT02819856|Drug|SPI-1005 Ebselen 200mg Capsule x3|600 mg SPI-1005 bid po x 21d
16009019|NCT02819843|Drug|TALIMOGENE LAHERPAREPVEC (TVEC)|
16008791|NCT02821689|Drug|Pirfenidone|Pirfenidone was administered in three divided doses (200mg tid), and increased to the manufacturer's instructed target dose (600mg tid) over a 2-week period. The maximum dose was maintained throughout the study in patients who tolerated it.
16008792|NCT02821676|Procedure|PECI/SPB Block with Active Anesthetic + Placebo Multilevel Intercostal Nerve Block followed by Latissimus Dorsi Flap Breast Reconstruction|30mL of 0.5% Ropivacaine with 1:200,000 epinephrine preoperatively via an ultrasound guided PECI/SPB regional block and 5mL of Normal Saline intraoperatively as an intercostal nerve block to each of the T2-T7 nerve segments
16008793|NCT02821676|Procedure|Placebo PEC/SPB Block + Multilevel Intercostal Nerve Block with Active Anesthetic followed by Latissimus Dorsi Flap Breast Reconstruction|30mL of Normal Saline via an ultrasound guided PECI/SPB block and 5mL of 0.5% Ropivacaine with 1:200,000 epinephrine as an Intercostal nerve block to each of the T2-T7 nerve segments
16008794|NCT02821663|Behavioral|vocal intervention|10 x 60 min. sessions of vocal intervention
16008795|NCT02821650|Other|TEJ (Traditional stove to Efficient stove in Jhuggi)|TEJ (means 'Bright' in Hindi) is an improved cook stove, locally designed and manufactured, aimed at reducing the indoor air emissions and improving health outcomes. 'Jhuggi' is a Hindi word which stands for a 'slum dwelling'
16008796|NCT02821637|Other|Eurofit Tests of Physical Fitness (Eurofit)|Eurofit tests are a physical skills assessment. For the study, tests performed on the 1st and the 13th session of the program, then 3 more times : 2 months, 6 months and 12 months after the 13th weekly session.
16008797|NCT02821637|Behavioral|Child Health Questionnaire (CHQ)|The CHQ is a questionnaire about quality of life. The CHQ children form (CHQ-CF87) and the CHQ parent form (CHQ-PF50) are completed each time the Eurofit tests are performed : at the 1st and 13th weekly session then 2 months, 6 months and 12 months later.
16008798|NCT02821637|Other|Effort rehabilitation program|Part of the routine practice of the Pediatric Obesity and Pediatric Diabetes Organization of Mulhouse, the program consists in 13 sessions of 1hour30 of adapted physical activity. The physical activity in this program use cycles of games where rules are adapted to the overweight or obese children. The activities are performed in a playful atmosphere, for example using creative games like tchoukball or peteca, with each session aiming a specific objective each time.
16008799|NCT02821624|Drug|G1T38 (CDK 4/6 Inhibitor)|CDK 4/6 Inhibitor
16008800|NCT02821624|Drug|Placebo|Placebo
16008801|NCT02821611|Behavioral|Meditation Group|twice daily 20 minute mantra-based meditation practice for 8 weeks
16008802|NCT02821598|Other|Upper Limb pattern with flexion - abduction - external rotation|"The PNF pattern will be applied three times. Participants will be in supine position under a stretcher, with arms folded and lower limbs in neutral position. In order to induce irradiation for the contralateral lower limb, the left foot sole will be kept in contact with the wall. For EMG recording, the participant will be positioned at the end of the PNF pattern and then the isometric contraction will be solicited. The command used was: do not let me move you."
16008803|NCT02821598|Other|Lower Limb pattern with flexion - adduction - external rotation with knee flexion|"The PNF pattern will be applied three times. Participants will be in supine position under a stretcher, with arms folded and lower limbs in neutral position. In order to induce irradiation for the contralateral lower limb, the left foot sole will be kept in contact with the wall. For EMG recording, the participant will be positioned at the end of the PNF pattern and then the isometric contraction will be solicited. The command used was: do not let me move you."
16008804|NCT02821598|Other|Lower Limb pattern with flexion - abduction - internal rotation with knee flexion|"The PNF pattern will be applied three times. Participants will be in supine position under a stretcher, with arms folded and lower limbs in neutral position. In order to induce irradiation for the contralateral lower limb, the left foot sole will be kept in contact with the wall. For EMG recording, the participant will be positioned at the end of the PNF pattern and then the isometric contraction will be solicited. The command used was: do not let me move you."
16008805|NCT02821598|Other|Lifting to the right|"The PNF pattern will be applied three times. Participants will be in supine position under a stretcher, with arms folded and lower limbs in neutral position. In order to induce irradiation for the contralateral lower limb, the left foot sole will be kept in contact with the wall. For EMG recording, the participant will be positioned at the end of the PNF pattern and then the isometric contraction will be solicited. The command used was: do not let me move you."
16008806|NCT02821598|Other|Sit to Stand|"Subjects will be sitting on a chair without armrests with ankles positioned at approximately 10 degrees of dorsiflexion. Knees will be kept at approximately 100 degrees of flexion. During the task, the participant will be instructed to stand from the sitting position while keeping their arms crossed over the chest. The examiner will give the command ready - set - go. The task will be performed three times."
16008807|NCT02821585|Behavioral|Nutritional Counseling|Carbohydrate counting will be reviewed, as well as hypoglycemia management. The 9 following visits will focus on different aspects of each diets: types of fats, meat and alternatives, grain products, milk and alternatives, fruits and vegetables, salt intake, energy density and restaurants.
16008808|NCT02821572|Biological|blood sample|
16008809|NCT02821572|Procedure|spleen sample|
16008810|NCT02821559|Drug|TOMOX|
16008811|NCT02821559|Drug|Bevacizumab|Bevacizumab was allowed and used at 7,5 mg/kg or 5 mg/kg every 2 weeks.
16008812|NCT02821546|Drug|Lactated Ringer's solution|Standard fluid hydration with Lactated Ringer's solution is calculated based on Holiday Segar's equation Aggressive hydration with Lactated Ringer's solution is defined as administration of 150 ml/hour of fluid
16008813|NCT02821533|Procedure|TACE|TACE is performed under local anesthesia with right femoral puncture. The feeding lobar hepatic artery is selectively catheterized for drug delivery.
16008814|NCT02821533|Drug|Cisplatin|Cisplatin will be mixed with a mixture of Lipiodol and ethanol (LEM), which consists of 33% ethanol by volume in Lipiodol, in a ratio of 2mg cisplatin per mL of LEM, and delivered through catheters or microcatheters to the tumors until there is flow reduction at the tumor feeders. The total dose of cisplatin given in each treatment session is limited to 100mg (50mL LEM) in each treatment session. The usual volume of LEM delivered will be 20 - 30 mL.
16008815|NCT02821520|Drug|conbercept|At baseline conbercept injection is administered.And thereafter is administered based on re-treatment criteria from month 1 to 11.The PRN conbercept re-injection should be monthly.
16008936|NCT02820545|Other|Self-administrated questionnaire|Self-administrated questionnaire will be performed by patients themselves at the end of hospital stay and one week after they left hospital
16008816|NCT02821520|Procedure|Initial PDT|At baseline PDT with verteporfin is administered initially.And thereafter PDT is administered based on re-treatment criteria from month 3 to 11.The PRN PDT retreatment intervals should be no less than 3 months.
16008817|NCT02821520|Procedure|Delayed PDT|PDT is administered based on re-treatment criteria from month 3 to 11.The PRN PDT retreatment intervals should be no less than 3 months.
16008818|NCT02821507|Drug|sirolimus and cyclophosphamide|
16008819|NCT02821494|Biological|Hespecta|A dose escalation of Amplivant® conjugated peptide
16008820|NCT02821481|Dietary Supplement|Beta-alanine|
16008821|NCT02821481|Dietary Supplement|Placebo|
16008822|NCT02821481|Behavioral|Muscular endurance exercise|
16008823|NCT02821468|Drug|Droglican|Combined Chondroitin Sulfate 1200 mg + Glucosamine Hydrochloride 1500 mg
16008824|NCT02821468|Drug|Paracetamol or oral NSAIDs excluding COX2 inhibitors|
16008825|NCT02821455|Procedure|Lung Surgery with One-Lung Ventilation|A single cohort of patients undergoing one-lung ventilation during lung surgery
16008826|NCT02821442|Device|Acupuncture|Acupuncture points selected on the arms and legs using both acupuncture and electroacupuncture to assess effectiveness in alleviating neuropathic pain caused by chemotherapy in breast cancer patients
16008827|NCT02821442|Device|Sham Acupuncture|Placebo needles appear to penetrate but do not actually penetrate the skin
16008828|NCT02821429|Other|Combined Thoracic Echography Record|This examination will be done to do the longitudinal follow-up of the patient
16008829|NCT02821416|Biological|Benralizumab|Benralizumab subcutaneously on study day 0 until study week 16 day 1 inclusive
16008830|NCT02821416|Other|Placebo|Placebo subcutaneously on study week 0 until study week 16 day 1 inclusive
16008831|NCT02821403|Device|clear lens with regular coating|
16008832|NCT02821403|Device|regular coating lens with yellow tint|
16008833|NCT02821403|Device|clear lens with blue-light blocking coating|
16008834|NCT02821390|Drug|Nepafenac Eye Drops|One drop instilled to the eye's cul de sac prior to the intravitreal injection.
16008835|NCT02821390|Drug|Placebo (Artificial Tears)|One drop instilled to the eye's cul de sac prior to the intravitreal injection
16008836|NCT02821377|Drug|intravenous furosemide|treatment with intravenous infusion of furosemide (doses 125-250mg⁄ bid) plus small volumes of HSS (150mL 1.4-4.6% NaCl), from the first day after admission until 3 days before discharge, with water restriction and a normal sodium diet.
16008837|NCT02821377|Drug|Hypertonic saline solutions|Intravenous small volumes of HSS (150mL 1.4-4.6% NaCl), plus treatment with intravenous infusion of furosemide (doses 125-250mg⁄ bid) from the first day after admission until 3 days before discharge, with water restriction and a normal sodium diet.
16008838|NCT02821377|Procedure|Seriated paracentesis|repeated paracentesis from the first day after admission until 3 days before discharge
16008839|NCT02821364|Other|Advanced Life Support|IV FLUIDS, INTUBATION
16008840|NCT02821351|Device|Radio frequency (RF) Cardiac ablation|Catheter based RF cardiac ablation to treat Paroxysmal Atrial Fibrillation
16008841|NCT02821338|Drug|Lamotrigine Extended Release|Lamotrigine Extended Release (generic) and Lamictal XR (brand).
16008842|NCT02821325|Other|MRI|"Patients undergoing a total knee arthroplasty, will undergo additional MRI's. One MRI pre-operatively.
~2nd MRI post-operatively on day 1. 3rd MRI post-operatively on day 2."
16008843|NCT02821312|Drug|DA-8010|"Part A will comprise a single-dose, sequential-group study incorporating a food effect evaluation. Total 70 subjects will be studied in 7 groups (Groups A1 to A7); 60 male and 10 female. Each group will consist of 10 subjects of the same sex and 8 subject for DA-8010.
~Part B will comprise a multiple-dose, sequential-group study. Total forty subjects (30 male and 10 female) will be studied in 4 groups (Groups B1 to B4), with each group consisting of 10 subjects of the same sex and 8 subject for DA-8010."
16008844|NCT02821312|Drug|Placebo|"Part A will comprise a single-dose, sequential-group study incorporating a food effect evaluation. Total 70 subjects will be studied in 7 groups (Groups A1 to A7); 60 male and 10 female. Each group will consist of 10 subjects of the same sex and 2 subject for DA-8010.
~Part B will comprise a multiple-dose, sequential-group study. Total forty subjects (30 male and 10 female) will be studied in 4 groups (Groups B1 to B4), with each group consisting of 10 subjects of the same sex and 2 subject for DA-8010."
16008845|NCT02821299|Other|Laryngeal transplantation|Laryngeal transplantation
16008846|NCT02821286|Other|Observational study|Blood sampling
16008847|NCT02821273|Other|Modified INSURE technique|modified INSURE means intubation-surfactant-X-ray relieved-extubation. Extubation and noninvasive ventilation is used after the X-ray relieving.
16008848|NCT02821273|Other|INSURE technique|INSURE means intubation-surfactant-extubation. Extubation and noninvasive ventilation is used after surfactant administration.
16008849|NCT02821247|Drug|Aflibercept (Eylea, BAY86-5321)|Intravitreal injection; should comply with the recommendations written in the local Summary of Product Characteristics (SPC) of the product
16008850|NCT02821234|Other|MRI|
16008851|NCT02821182|Radiation|stereotactic body radiotherapy|"In patients with metastatic melanoma, anti-PD-1 treatment will be combined with stereotactic body radiotherapy (SBRT).
~A total dose of 24 Gy SBRT will be delivered in 3 fractions to one measurable lesion and fractions will be separated >48h and <96h."
16008852|NCT02821169|Drug|ropivacaine|injection of 4mL of ropivacaine in the sphenopalatine area through an endoscopic approach
16008853|NCT02821169|Drug|saline solution 0.9%|injection of 4 mL of saline solution in the sphenopalatine area through an endoscopic approach
16008854|NCT02821143|Other|usual palliative care|Residents in the control group will receive usual palliative care usually delivered in their nursing homes , according to the habits of the healthcare team and their physician.
16008890|NCT02820844|Drug|GSK1358820|GSK1358820 injection contains botulinum toxin type A (100 U), sodium chloride (0.9 milligrams [mg]), and human serum albumin (0.5 mg). 10 mL of the drug will be injected at 20 sites (0.5 mL at each site) in the detrusor muscle, spaced approximately 1 centimeter (cm) apart. The injection will be administered under local anesthesia, via cystoscopy. Permitted anesthesia options for cystoscopy are intraurethral lidocaine (or similar) gel, and for treatment administration, installation of 1-2% lidocaine (or similar anesthetic) into the bladder.
16009015|NCT02819856|Drug|Placebo|0 mg SPI-1005 bid po x 21d
16009016|NCT02819856|Drug|SPI-1005 Ebselen 200mg Capsule x1|200 mg SPI-1005 bid po x21d
16009679|NCT02814968|Device|18-FDG PET/CT|
16008855|NCT02821143|Other|Telemedicine consultation|"Establishment of an initial multiprofessional Telemedicine consultation involving a palliative care physician and / or geriatrician, and other physician coordinator of nursing homes, health care team and if possible the patient's treating physician (patient and / or family may participate if they want to).
~The aim is to define and formalize:
~Aid to collection and application of advanced directives according to Leonetti Act if the resident is able to do so, or collection of confidence personal choices.
~Definition of the objectives of care and patient's life and therapeutic adaptation with a focus on pain and uncomfortable symptoms.
~Access to a mobile team of palliative care or geriatric hospitalization at home, a hospice network, if the patient's situation requires.
~In case of medical worsening :
~Possibility of access to consultations and use of emergency by tele-expertise or decision support within a maximum period of 72 hours, with the same objectives that above."
16008856|NCT02821117|Device|FreeStyle Libre Flash Glucose Monitoring System|"Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System masked for 14 days followed by 8 weeks unmasked wear.
~During the 2 weeks of masked device wear participants will use the BG strip port for self-monitoring of blood glucose (SMBG). Scanning the sensor at least every 8 hours during this phase.
~Followed by 8 weeks of unmasked device wear when participants will use the device (Sensor glucose and SMBG) according to labelling for their day to day management."
16008857|NCT02821091|Other|Interactive Dynamic Balance Training|
16008858|NCT02821078|Other|4D flow imaging sequence|4D flow imaging sequence
16008859|NCT02821065|Device|Remote Patient Monitoring|
16008860|NCT02821052|Drug|insulin degludec/insulin aspart|Enrolled patients will be treated with Ryzodeg® under routine clinical practice.
16008861|NCT02821026|Procedure|Omental Islet transplant|The intervention is transplanting the islets into an omental pouch instead of into the liver. The omentum is a large apron-like fold of membrane inside the abdomen that drapes over the intestines. This study will test to see if omental islet transplantation is safe and effective. Standard immunosuppressive medicines (anti-thymocyte globulin, tacrolimus, mycophenolic acid, sirolimus, etanercept) will be used in this study to prevent rejection of the islets.
16008862|NCT02821026|Drug|Anti-Thymocyte Globulin|
16008863|NCT02821026|Drug|Mycophenolate mofetil|
16008864|NCT02821026|Drug|Tacrolimus|
16008865|NCT02821026|Drug|Etanercept|
16008866|NCT02821026|Drug|Sirolimus|Sirolimus will be used in case of tacrolimus or/and mycophenolate mofetil intolerance.
16008867|NCT02821013|Drug|Intermittent PD-1 inhibitor therapy|
16008868|NCT02821013|Drug|Continuous PD-1 inhibitor therapy|
16008869|NCT02821000|Biological|Pembrolizumab|Intravenous infusion
16008870|NCT02820987|Drug|MEROPENEM|Administration of MEROPENEM according to a protocol of extended infusion defining dose and duration of infusion.
16008871|NCT02820987|Drug|PIPERACILLIN-TAZOBACTAM|Administration of PIPERACILLIN-TAZOBACTAM according to a protocol of continuous infusion defining dose and duration of infusion.
16008872|NCT02820987|Drug|CEFEPIME|Administration of CEFEPIME according to a protocol of continuous infusion defining dose and duration of infusion.
16008873|NCT02820961|Drug|entinostat|An orally available histone deacetylases inhibitor (HDAC)
16008874|NCT02820961|Drug|exemestane|Aromatase inhibitor
16008875|NCT02820948|Drug|Vitamin E ointment application|Before the skin stapling and after the subcutaneous irrigation with normal saline, sterile Vitamin E acetate ointment was applied in the subcutaneous tissue; 2 ml were applied in the suprapubic incision and 0.5 ml in the rest of port sites.
16008876|NCT02820935|Drug|CC-220|
16008877|NCT02820935|Drug|Rifampin|
16008878|NCT02820935|Drug|Itraconazole|
16008879|NCT02820922|Procedure|Orthopedic|anesthesia techniques with regard to age, sex, ASA score, anaesthesia technique, comorbidities, surgery diagnosis, length of surgery, complications and admission to intensive care unit after surgery
16008880|NCT02820909|Procedure|venous and arterial catheter set-up using ultrasound guidance|The insertion of the venous and arterial catheter will be done using ultrasound guidance. Vein and artery will be identified in cross section. In case of anatomical difficulties, complications of puncture with anatomical landmarks, or if installation time is greater than > 5 minutes, an intra-osseous catheter will be put in place to avoid delaying of treatment according to the current practice of the intensive care unit.
16008881|NCT02820909|Procedure|Anatomical guidance.|"In the anatomical group, catheter will be inserted using, as it is currently done in intensive care unit, anatomic landmarks. If catheterization according to the anatomic method is considered too difficult (> 3 punctures), a conversion to ultrasound guidance will be done.
~In case of anatomical difficulties, complications of puncture with anatomical landmarks, or if installation time is greater than > 5 minutes, an intra-osseous catheter will be put in place to avoid delaying of treatment according to the current practice of the intensive care unit."
16008882|NCT02820896|Drug|Placebo|Participants will receive single or multiple doses of RO7105705 matching placebo IV.
16008883|NCT02820896|Drug|RO7105705|Participants will receive single or multiple doses of RO7105705 IV or SC.
16008884|NCT02820883|Biological|Staphylococcus aureus vaccine (60µg/per protein)|two doses of 60µg/0.6ml per dose
16008885|NCT02820883|Biological|Staphylococcus aureus vaccine (30µg/per protein)|two doses of 30µg/0.6ml per dose
16008886|NCT02820883|Biological|Staphylococcus aureus vaccine (15µg/per protein)|two doses of 15µg/0.6ml per dose
16008887|NCT02820870|Behavioral|Statin Decision Support Intervention|"The investigators have developed a mock medical record decision support tool for this project. Each week the investigators will pull a list of patients scheduled for a primary care visit at the Ann Arbor VAMC then calculate each patient's risk based on the clinical guidelines algorithm and compare the statin recommendation against their current prescriptions. For each patient whose current medication therapy is not consistent with the new guidelines (i.e., are guideline discordant), a brief recommendation will be generated. Each day the research assistant will deliver a hardcopy of these patient specific recommendations to the providers for their use. In addition, providers will receive monthly audit and feedback reports on the percentage of their patients meeting the guideline."
16008888|NCT02820857|Drug|Folfiri-bevacizumab|Patient treated with a combination Folfiri-bevacizumab. Treatment every 2 weeks (D1 = D15)
16008889|NCT02820857|Drug|Folfiri|Patient treated with Folfiri only. Treatment every 2 weeks (D1 = D15)
16008931|NCT02820610|Drug|Normal saline 0.9 %|2 mg/kg bupivacaine 0.5% diluted in normal saline 0.9 % will instilled into the peritoneal cavity.
16008891|NCT02820844|Drug|Placebo|Placebo injection is made up of sodium chloride (0.9 mg). 10 mL of the injection will be injected at 20 sites (0.5 mL at each site) in the detrusor muscle, spaced approximately 1 cm apart. The injection will be administered under local anesthesia, via cystoscopy. Permitted anesthesia options for cystoscopy are intraurethral lidocaine (or similar) gel, and for treatment administration, installation of 1-2% lidocaine (or similar anesthetic) into the bladder.
16008892|NCT02820844|Drug|Antibiotic therapy|Subjects will use prophylactic antibiotic therapy approved for the indication of UTIs, at the discretion of the investigator, with the exception of those in the class of aminoglycosides. The therapy will begin 1 to 3 days prior to the administration of study treatment, and continue for 1 to 3 days following the treatment.
16008893|NCT02820844|Other|Bladder diary|The bladder diary is a self-reporting tool to record subject's data on micturition. Subjects will enter data in the diary over 3 consecutive days. During Screening, data will be collected within 28 days prior to first treatment. During treatment periods, data will be collected within a week prior to each scheduled visit. The bladder diary will capture the following information: 1) Date and time of urinary episode, 2) episodes of micturition, 3) episodes of urinary incontinence, 4) episodes of urgency, 5) intensity of urgency, 6) episodes of nocturia, 7) use of CIC, and 8) urine volume. Diary data will not be collected when a subject experiences symptoms of a UTI.
16008894|NCT02820844|Other|King's Health Questionnaire (KHQ)|The KHQ will assess the impact of urinary incontinence on QOL. It is a questionnaire with 21 items and the following 9 domains: 1) General health, 2) Incontinence impact, 3) Role limitations, 4) Physical limitations, 5) Social limitations, 6) Personal relationships, 7) Emotion, 8) Sleep/energy, 9) Severity measure. The items are answered by subjects themselves, and scores are summated using a defined algorithm.
16008895|NCT02820844|Other|Overactive Bladder Symptom Score (OABSS)|The OABSS will comprehensively assess symptoms of OAB, such as frequency of micturition, nocturia, urinary urgency, and urge incontinence. It consists of 4 questions which will be responded by subjects themselves, by selecting the most appropriate answer for each question.
16008896|NCT02820844|Other|Treatment Benefit Scale (TBS)|"The TBS consists of one question (My condition has), to which the subject will answer by selecting one of the following responses: greatly improved, improved, not changed, worsened. The TBS will assess treatment benefit of GSK1358820."
16008897|NCT02820805|Other|Meal Skipping|No meal
16008898|NCT02820805|Other|French fries|50g of available carbohydrates meal
16008899|NCT02820805|Other|Mashed potatoes|50g of available carbohydrates meal
16008900|NCT02820805|Other|Hash browns|50g of available carbohydrates meal
16008901|NCT02820805|Other|Rice|50g of available carbohydrates meal
16008902|NCT02820805|Other|Beans|50g of available carbohydrates meal
16008903|NCT02820792|Procedure|function tests|function tests: ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion
16008904|NCT02820792|Device|LMA ProtectorTM|
16008905|NCT02820792|Device|Ambu AuraGainTM|
16008906|NCT02820779|Device|WILLIS|WILLIS® intracranial stent graft system is composed of the stent, delivery system, cobalt-based alloy stent and PTFE graft. It can effectively shunt the blood flow and keep it off of the aneurysm wall.
16008907|NCT02820753|Behavioral|EHR + (Text or Portal)|"Per protocol analysis:
~Patients who received the initial 6 weeks of SMS messaging continuously, or logged on to the patient portal and completed at least one survey."
16008908|NCT02820740|Device|NeuroBlate System|Laser Interstitial Thermal Therapy
16008909|NCT02820714|Drug|BLI801 Laxative|BLI801 Laxative
16008910|NCT02820701|Procedure|OMT|Osteopathic Manipulative Treatment to low back region
16008911|NCT02820688|Drug|Bupivacaine 0.25%|
16008912|NCT02820688|Drug|Prilocaine 1%|
16008913|NCT02820688|Procedure|Infraclavicular Nerve Block|Ultrasound guided infraclavicular nerve block
16008914|NCT02820688|Drug|Bupivacaine 0.167%|
16008915|NCT02820688|Drug|Bupivacaine 0.125%|
16008916|NCT02820688|Drug|Prilocaine 0.66%|
16008917|NCT02820688|Drug|Prilocaine 0.5%|
16008918|NCT02820688|Device|Ultrasound|All nerve blocks will be performed with ultrasound guidance
16008919|NCT02820675|Other|structured case analysis|implementation of a structured analysis of cases coded as sepsis, severe sepsis, or septic shock after risk adjustment for low-risk-fatalities, high-risk-survivors, and coding errors for preventable deaths, best practice, quality improvement and improvement in coding precision.
16008920|NCT02820675|Other|"strucured screening every patient, every shift"|implementation of a strutured screening and rescue algorithm on regular wards, emergency departements, and intermediate and intensive care units by checking every patient in every shifts for clinical signs of deterioration and apllying a rescue algorithm including consiliary help and/or the help of outreach teams
16008921|NCT02820662|Other|RETCAM|
16008922|NCT02820662|Biological|Blood samples|
16008923|NCT02820649|Other|Sleep deprivation|40 hours of continuous wakefullness
16008924|NCT02820636|Behavioral|S-CBT|The SCBT-SB protocol has 3 phases. Phase I, which is fixed (core sessions), includes 9 sessions (1 family, 5 individual & 3 caretakers sessions). Topics include: understanding the suicidal crisis, identity in adolescence, chain analysis, communication skills, the power of thought and decision making, parenting skills, rearing in a different culture, and family communication. Phase II is flexible and consists of coping skills modules (thoughts, emotional regulation, social interactions, activities, substance abuse, family communication & trauma). The treatment plan is adjusted to adolescents' needs. Family and primary caregiver sessions are flexible, depending on the family/caregivers' needs. Participants have received an adequate course of treatment if they at least complete the core sessions. This protocol should take 3-6 months. Once the active phase ends, booster sessions are recommended.
16008925|NCT02820636|Behavioral|Treatment as Usual|Intensive outpatient therapy with teens and their parents using a variety of eclectic treatments that characterize standard care for adolescents.
16008926|NCT02820623|Behavioral|Self-report|
16008927|NCT02820623|Behavioral|Chart-Stimulated Recall|
16008928|NCT02820623|Behavioral|Behavioral Rehearsal|
16008929|NCT02820610|Drug|Dexmedetomidine|2 mg/kg bupivacaine 0.5% and 1 ug/kg of dexamedetomidine diluted in normal saline 0.9 % will instilled into the peritoneal cavity
16008930|NCT02820610|Drug|Magnesium Sulfate|2 mg/kg bupivacaine 0.5% and 30 mg/kg of magnesium sulfate diluted in normal saline 0.9 % will instilled into the peritoneal cavity
16008937|NCT02820532|Device|Protura Treatment table|The treatment couch will be moved according to the respiratory motion of the patient. As a reference first the respiration will be measured without couch motion, than the couch will be switched on and we will evaluate if the respiration changes due to the motion of the couch. This procedure will be repeated once.
16008938|NCT02820519|Drug|Loxapine|Loxapine dose escalation according to tolerability and analgesic efficacy
16008939|NCT02820506|Procedure|SLN mapping and removal of PET-positive lymph nodes|Sentinel node mapping will be performed, followed by systematic removal og PET/CT positive lymph nodes
16008940|NCT02820493|Drug|vedolizumab|
16008941|NCT02820480|Device|Rehab in a Crate System|"The therapy gym is Rehab in a Crate with 4 stations for upper and lower limb assessment/therapy. Each station will allow adaptive game-based therapy.
~Note: The device is not being used at this moment for diagnostic or evaluation. Users will be asked to explore the device, try the systems, and provide feedback about use."
16008942|NCT02820467|Device|fluorescence angiography|Injection of indocyanine grey in an antecubital vein at the posology of 0.05 mg/kg
16008943|NCT02820454|Drug|AGuIX|A single intravenous injection on day 1. Dose level 1: 15mg/kg; Dose level 2: 30mg/kg, Dose level 3: 50mg/kg; Dose level 4: 75mg/kg; Dose level 5: 100mg/kg
16008944|NCT02820454|Radiation|whole brain radiation therapy|30Gy in 10 sessions of 3Gy (5 days a week in weeks 1-2); first session 4 hours after AGuIX injection.
16008945|NCT02820441|Drug|Zopiclone|
16008946|NCT02820441|Drug|Placebo|
16008947|NCT02820428|Other|Healthy participants|Semi-structured interview
16008948|NCT02820415|Other|chromosomal status of blastocysts from fresh and vitrified/warmed oocytes|
16008949|NCT02820389|Procedure|Optical colonoscopy|Patients with suspected colorectal cancer in this group will undergo Optical Colonoscopy as the initial imaging modality.
16008950|NCT02820389|Procedure|CTC|Patients with suspected colorectal cancer in this group will undergo Computed Tomography Colonography (CTC) as the initial imaging modality. Subsequent imaging might be required based on the findings from the CTC scan, i.e. patients with medium to large polyps or colorectal cancer will undergo Optical Colonoscopy as the second imaging test.
16008951|NCT02820376|Other|Differential renal function assessment by 4D CT|Low dose 4D (perfusion) renal acquisition after injection of iodinated contrast medium (ICM) (13 passes every 3 seconds, 3 passes every 10 seconds); estimated additional DLP 400 mGy.cm No additional contrast medium
16008952|NCT02820363|Device|"CERAMENT|G"|"Surgical repair of tibia fracture, CERAMENT™|G applied to bony voids."
16008953|NCT02820363|Procedure|SOC treatment|surgical repair of tibial fracture
16008954|NCT02820350|Device|SCD-F40|CRRT with SCD
16008955|NCT02820324|Drug|Oliceridine|
16008956|NCT02820324|Drug|Placebo|
16008957|NCT02820324|Drug|Morphine|
16008958|NCT02820311|Drug|TD-4208 175 mcg|via nebulizer
16008959|NCT02820311|Drug|TD-4208 700 mcg|via nebulizer
16008960|NCT02820311|Drug|Placebo for TD-4208|via nebulizer
16008961|NCT02820311|Drug|Moxifloxacin 400 mg|oral
16008962|NCT02820298|Drug|Bexagliflozin|Bexagliflozin tablet, 20 mg
16008963|NCT02820285|Other|Evaluation of the staging of fibrosis liver|The investigators will determine the severity of steatosis, inflammation and fibrosis by histological study of liver biopsies
16008964|NCT02820285|Other|Determine the expression level of semaphorin|The investigators will determine the expression level (gene and protein) of immune semaphorin and their (s) receptor (s) in the liver and subcutaneous and visceral adipose tissue by RT-PCR,
16008965|NCT02820285|Other|Determination of the composition of immunity cells|"The investigators determine the composition of immunity cells by immunohistochemical and biochemical analyses (Western Blotting
~)"
16008966|NCT02820272|Procedure|NPWT with cold water|Each of dressing change would be treated with NPWT and injection of cold sterile water kept in 4°C temperature into sponge 10 minutes before dressing change
16008967|NCT02820272|Procedure|NPWT with normal saline room temp|Each of dressing change would be treated with NPWT and injection of room temperature sterile water kept in room temperature into sponge 10 minutes before dressing change
16008968|NCT02820272|Procedure|NPWT without other intervention|Each of dressing change would be treated with NPWT without injection of any liquids into sponge before dressing change
16008969|NCT02820259|Drug|Tacrolimus|
16008970|NCT02820246|Other|nutrition|type and amount of food eaten or type of oral nutritional supplements as well as enteral or parenteral nutrition
16008971|NCT02820194|Radiation|Stereotactic Body Radiation Therapy|Stereotactic body radiation is a therapy for delivering a conformal high dose of radiation to the tumor and a minimal dose to surrounding critical tissues, with a hypofractionation schedule
16008972|NCT02820194|Procedure|Microwave Ablation|Microwave ablation (MWA) is a newer technology that utilizes high-frequency electromagnetic radiation to create thermal damage and coagulation necrosis
16008973|NCT02820181|Device|novel tracheostomy bi-ties|The investigators designed a novel tracheostomy bi-tie to ensure the safety and conveniences during exchanging and cleaning them, the primary feature of which is double belts and easy to operate.
16008974|NCT02820181|Device|traditional Tracheostomy ties|Traditionally, the tracheostomy tube is fixed using ordinary tracheostomy ties made of medical bandage or long strands.
16008975|NCT02820155|Drug|RGN1016|Stage I: single oral dose Stage II: multiple oral dose (QD, 7days)
16008976|NCT02820155|Drug|Placebo|Stage I: single oral dose Stage II: multiple oral dose (QD, 7days)
16008977|NCT02820129|Device|Medication Wallet Card|A medication wallet card will be given to the intervention group. This will be personalized for each patient and will include the patient's medications, dosages, and medical conditions. It will be personally given to a patient after a medical appointment with their family physician.
16008978|NCT02820129|Device|Reminder Card|"A reminder card will be given to this group. The card will not be personal and will be mailed to patients. It will state, Remember to keep an up-to-date listing of your medications and bring your medications to your doctor's appointments."
16008979|NCT02820116|Drug|Icotinib|In the neoadjuvant treatment phase, eligible patients will receive 125mg of Icotinib three times per day for 8 weeks (56 days). In the post-surgery phase, Icotinib 125mg/three tims/day taken orally for 2 years or till disease progression or unacceptable toxicity.
16009017|NCT02819856|Drug|SPI-1005 Ebselen 200mg Capsule x2|400 mg SPI-1005 bid po x 21d
16008980|NCT02820103|Behavioral|Text+Visual BCT-based intervention|Participants in the visual intervention group will receive usual care specified below plus a specifically developed Text + Visual BCT-based intervention, comprising 12 BCTs identified from SR and expert consensus study. An animated video, just under 8 minutes in length is hosted online in the Intervention Modelling Experiment. The animation contains 9 of the 12 BCTs and tells the 'delay stories' of three different characters. It was not possible to deliver all of the 12 BCTs comprehensively in the relatively passive media of the animation as some techniques require active participation from participants (e.g. action planning). Thus, n=7 BCTs (1 2 Problem-solving; 1 4 Action planning; 5 2 Salience of consequences; 7 1 Prompts/cues; 9 3 Comparative imagining of future outcomes; 15 2 Mental rehearsal of successful performance) are also delivered via short web-based exercises which follow the animation.
16008981|NCT02820103|Behavioral|Text-only BCT intervention|Participants in the text-only BCT-based intervention group will receive the usual care specified above plus a text-only BCT-based intervention. This was developed in the same way as the text + visual BCT-based intervention but does not include the visual elements (i.e. animation). Instead, the voiceover from the animated film is displayed in text on screen and narrated in audio. The BCTs which require active engagement are delivered via identical web-based exercises as the text + visual BCT-based intervention.
16008982|NCT02820103|Behavioral|Leaflet information (control)|Participants in the control group will receive information that is currently used routinely in the NHS site to inform patients with ACS what to do if they experience symptoms after discharge.
16008983|NCT02820077|Device|Hemospray (Endoscopic treatment with hemostatic powder)|Malignant bleeding lesions will be treated with endoscopic powder and patients will receive optical clinical management afterwards
16008984|NCT02820064|Procedure|duodenal biopsy during gastroduodenal endoscopy|Patients for who and esophagogastroduodenoscopy in order to diagnose is performed. 8 duodenal biopsy specimens will be removed.
16008985|NCT02820051|Device|Transcutaneous CO2 monitor|Measurement and surveillance of transcutaneous CO2 pressure (PtcCO2) to determine PtcCO2 behavior for each sedation group.
16008986|NCT02820051|Drug|Midazolam|The initial dose was 0.05 mg/kg. Additional doses of 2 mg of midazolam were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale.
16008987|NCT02820051|Drug|Propofol|The initial dose was 0.1 mg /kg. Additional doses of 10 mg of propofol were allowed to reach a score level of three to four in the Observer´s assessment of alertness/ sedation scale.
16008988|NCT02820051|Drug|Nalbuphine|The starting dose was 2 mg with additional doses of 1 mg if it was necessary.
16008989|NCT02820051|Drug|Lidocaine|Lidocaine spray was applied to the nasal mucosa and pharynx for bronchoscope nostril insertion, and only in the pharynx for bronchoscope oral insertion. Topical lidocaine was applied using the spray-as-you-go technique, at a maximum dose of 7 mg/kg.
16008990|NCT02820038|Behavioral|Medication Guides|The investigators will compare the effectiveness of two types of written prescription drug information targeted for patients: (1) Medication Guides mandated by the Food and Drug Administration, and (2) Drug Facts Boxes, developed by Woloshin and Schwartz.
16008991|NCT02820038|Behavioral|SMART Program|The investigators will determine if the effectiveness of written medication information can be increased by Gist Reasoning Training, delivered via the SMART Program, which is designed to enhance patients' ability to extract meaningful gist from complex information.
16008992|NCT02820038|Behavioral|Drug Facts Boxes|The investigators will compare the effectiveness of two types of written prescription drug information targeted for patients: (1) Medication Guides mandated by the Food and Drug Administration, and (2) Drug Facts Boxes, developed by Woloshin and Schwartz.
16008993|NCT02820025|Drug|doxapram|
16008994|NCT02820025|Other|saline|
16008995|NCT02820012|Other|Scoliosis|Questionnaires, radiography
16008996|NCT02819999|Drug|Rovalpituzumab Tesirine|Rovalpituzumab tesirine is a DLL3 targeted antibody drug conjugate (ADC).
16008997|NCT02819999|Drug|Cisplatin|
16008998|NCT02819999|Drug|Etoposide|
16008999|NCT02819986|Behavioral|Progressive Goal Attainment Program|Behavioural intervention that consists of 10 one hour weekly therapy sessions that focus on goal setting, challenging thoughts about return to work, problem solving, behavioural activation, and resuming occupational roles.
16009000|NCT02819973|Other|Educational Video1|
16009001|NCT02819973|Other|Educational Video 2|
16009002|NCT02819973|Other|Usual Care 3|
16009003|NCT02819960|Drug|PROBIO-FIX INUM®|Each capsule contents: 2 lyophilized probiotic strains, total amount of minimum 7x10 9 CFU/cps, ratio LGG®: BB-12® = 50% : 50% (Culture percentages are based on cell concentration and are approximate) Lactobacillus rhamnosus GG® (ATCC 53103) Bifidobacterium animalis subsp. lactis BB-12® (DSM 15954) Additives: maltodextrin, microcrystalline cellulose, silicium dioxide, magnesium stearate
16009004|NCT02819960|Drug|Placebo|Maltodextrin
16009005|NCT02819947|Other|This is an observational prospective study.|Investigators will get clinical information including gender, date of birth, height, weight, family history for systemic sclerosis, education, and symptoms of organ involvement of skin, lung, heart, gastrointestinal tract, kidney, musculoskeletal system and laboratory data. Investigators will evaluate nailbed capillary microscope, hand x-ray, 6 minute walk test, echocardiography, computed tomography of chest, pulmonary function test (FVC%, DLCO%), and electrocardiogram as baseline. Investigators permit replacement of previous results within one year from baseline. Participants in the cohort will be followed up annually and investigators will treat SSc patients according to their routine practice in the best interest of patents. Medications for other comorbid conditions are allowed.
16009006|NCT02819934|Drug|KD101|after 10 min KD101 administered, 14C KD101 3.52ug/1ml administrated. both of them will be administrate for oral
16009007|NCT02819921|Drug|Desvenlafaxine succinate 100mg|Pristiq 100mg
16009008|NCT02819921|Drug|Desvenlafaxine succinate 50mg|Pristiq 50mg
16009009|NCT02819921|Drug|Placebo|Placebo
16009010|NCT02819908|Drug|Imprimis Dropless|Tri-Moxi-Vanc transzonular intravitreal injection
16009011|NCT02819908|Drug|Imprimis Less Drops|Pred-Moxi-Ketorolac and Pred-Ketorolac topical instillation qd postoperatively
16009012|NCT02819895|Other|A customized windows® software application|A customized windows® software application with the ability to send automated voice call, SMS and email reminder about due dates for childhood routine immunizations.
16009013|NCT02819882|Other|No intervention|
16009014|NCT02819869|Drug|Statin and Metformin use|
16009021|NCT02819830|Behavioral|Exercise Intervention|Combined strength and aerobic exercise
16009022|NCT02819817|Drug|Aloe Vera Gel|The participant will be asked to place the allocated substance onto the wound twice daily and cover with a supplied dressing on each occasion for 1 week.
16009023|NCT02819817|Other|Ultrasound gel|The participant will be asked to place the allocated substance onto the wound twice daily and cover with a supplied dressing on each occasion for 1 week.
16009024|NCT02819804|Drug|Dasatinib|Given PO
16009025|NCT02819804|Other|Laboratory Biomarker Analysis|Correlative studies
16009026|NCT02819804|Biological|Nivolumab|Given IV
16009027|NCT02819804|Other|Pharmacological Study|Correlative studies
16009028|NCT02819791|Other|Optimized conventional therapy alone|Patients will benefit from a traditional follow-up as provided for this type of patients at 3 months and 1 year
16009029|NCT02819791|Behavioral|Optimized conventional therapy with therapeutic education|"The objectives of this therapeutic education program involve:
~learning objectives and acquisition of knowledge and self-care skills making the patient more autonomous and facilitating its adherence.
~the objectives of acquiring coping skills ( self-confidence , stress management , setting projects ) to improve their quality of life .
~the development objectives respects the relevant criteria of quality , realism and principle of educational progress."
16009030|NCT02819778|Procedure|usual care|
16009031|NCT02819778|Procedure|S100B|
16009032|NCT02819752|Drug|Pembrolizumab|Pembrolizumab
16009033|NCT02819752|Radiation|Radiotherapy|Radiotherapy - Standard Treatment
16009034|NCT02819752|Drug|Chemotherapy|Chemotherapy - Standard Treatment
16009035|NCT02819739|Drug|medical oxygen|
16009036|NCT02819726|Biological|SAIT101|1,000 mg i.v. of SAIT101 on Day 1 and 15. 1,000 mg i.v. of SAIT101 on week 24 and 26 for eligible patients.
16009037|NCT02819726|Biological|MabThera|1,000 mg i.v. of MabThera® on Day 1 and 15. 1,000 mg i.v. of MabThera® on week 24 and 26 for eligible patients.
16009038|NCT02819726|Biological|Rituxan|1,000 mg i.v. of Rituxan® on Day 1 and 15. 1,000 mg i.v. of Rituxan® on week 24 and 26 for eligible patients.
16009039|NCT02819713|Other|ultrasound gel|
16009040|NCT02819713|Other|Instillagel|
16009041|NCT02819700|Behavioral|prevalence of behavioural dysexecutive syndrome|Behavioural Dysexecutive Syndrome Inventory (ISDC)
16009042|NCT02819687|Drug|RDX5791|
16009043|NCT02819687|Drug|Placebo|
16009044|NCT02819661|Device|SOMNOTOUCH RESP|Ventilatory effort recorder
16009045|NCT02819661|Procedure|Caesarean section|Cesarean delivery is defined as the delivery of a fetus through surgical incisions made through the abdominal wall (laparotomy) and the uterine wall (hysterotomy).
16009046|NCT02819661|Drug|Spinal anesthesia with intrathecal morphine|is a form of regional anaesthesia involving injection of a local anaesthetic into the subarachnoid space
16009047|NCT02819648|Drug|Prednisolone|40 mg prednisolone (two tablets Prednisolone 20 mg, Aventis Intercontinental, Paris, France)
16009048|NCT02819648|Other|Control|Milk Tablet
16009049|NCT02819635|Drug|Placebo|Tablet; Oral
16009050|NCT02819635|Drug|Updacitinib (ABT-494)|Tablet; Oral
16009051|NCT02819609|Procedure|myomectomy|Myomectomy as part of routine clinical care
16009052|NCT02819609|Procedure|endometrial ablation|Endometrial ablation as part of routine clinical care
16009053|NCT02819609|Procedure|uterine artery embolization|Uterine artery embolization as part of routine clinical care
16009054|NCT02819609|Procedure|MRI-guided focused ultrasound ablation|MRI-guided focused ultrasound ablation as part of routine clinical care
16009055|NCT02819596|Drug|Savolitinib|
16009056|NCT02819596|Drug|MEDI4736|
16009057|NCT02819596|Drug|Tremelimumab|
16009058|NCT02819583|Biological|PCAR-019 (anti-CD19 CAR-T cells)|
16009059|NCT02819570|Drug|I.V cefuroxime 750 mg*3/d for 2 days|
16009060|NCT02819570|Drug|I.V ampicillin 2 gram x4/d for 2 days|
16009061|NCT02819570|Drug|P.O cefuroxime 500 mgx2/d for 5 days|
16009062|NCT02819570|Drug|P.O roxithromycin 150 mg*2/d for 7 days|
16009063|NCT02819570|Drug|P.O moxypen 500 mgx3/d for 5 days|
16009064|NCT02819557|Drug|Ataluren|White to off-white powder for oral suspension.
16009065|NCT02819544|Drug|Sodium chloride administration|Sodium chloride administration
16009066|NCT02819544|Drug|Ropivacaine administration|Ropivacaine administration
16009067|NCT02819531|Device|Rotational atherectomy|Pre-stenting lesion modification using the rotational atherectomy device using standard technique under intravenous infusion of heparin. Burr size will be selected by the operator according to vessel size. IVUS images will be obtained before lesion modification and after stenting.
16009068|NCT02819531|Device|Orbital atherectomy|Pre-stenting lesion modification using the orbital atherectomy device according the manufacturer's guidelines. IVUS images will be obtained before lesion modification and after stenting.
16009069|NCT02819531|Device|Scoring balloon system|Pre-stenting lesion modification using the scoring balloon system according the manufacturer's guidelines. IVUS images will be obtained before lesion modification and after stenting.
16009076|NCT02819505|Dietary Supplement|beta-alanine|
16009077|NCT02819505|Dietary Supplement|Placebo|
16009078|NCT02819479|Drug|25% Mannitol|"Route of administration:
~In this study, the first step of the treatment will be performing osmotic blood-brain-barrier disruption with administration of intra-arterial 25% Mannitol into the appropriate cervical artery."
16009079|NCT02819479|Drug|Low-dose Intra-arterial Bevacizumab|"Route of administration:
~In this study, the second step of the treatment will be administering intra-arterial targeted bevacizumab into the appropriate cervical artery."
16009080|NCT02819466|Device|3D echography|ultrasound visualization of the stomach in fasting patients.
16009162|NCT02818764|Procedure|Blood Draw|5 mL of blood from the patients preoperative, postoperative, 1 day and 2 days after surgery for a total of 20 mL.
16009081|NCT02819440|Drug|Tadalafil|Tadalafil is an FDA approved, clinically-available drug that inhibits the enzyme phosphodiesterase type 5A (PDE5). Subjects who are randomized to this arm will be provided with 20mg of Tadalafil to take every day for 12 weeks, beginning at their baseline visit.
16009082|NCT02819440|Drug|Placebo|100 patients will be randomized to receive a placebo pill. Subjects in this arm will be provided with 20mg Placebo to take every day for 12 weeks, beginning at their baseline visit.
16009083|NCT02819427|Device|Near Infra Red Spectroscopy (NIRS)|
16009084|NCT02819427|Device|Electroencephalography (EEG)|Electroencephalography (EEG) in a simultaneous High-Resolution (HR) recording.
16009085|NCT02819414|Drug|Paracetamol drops|15 mg/kg/dose x 4/day diluted 1:15 yielding dose of 2.25 ml/kg/dose to be given for three days
16009086|NCT02819414|Other|Placebo|2.25 ml/kg/dose x 4/day of sterile water to be given for three days
16009087|NCT02819401|Other|pediatric formula|high-fiber enteral formula
16009088|NCT02819388|Behavioral|Contraceptive counseling|A culturally adapted counselling session lasting up to 45 minutes at the community setting. The interview is based in WHO guidelines and communication tools, in social cognitive theory and in motivational interviewing. Along the interview, topics follow easy to read leaflets prepared to discuss the main benefits of contraception from the view of the immigrant communities, with guided discussions on family planning in the life course, the amount of time required to care children, the economic resources that newborn and children need, and an assessment of the knowledge on the contraceptive methods, and of their current use. Contraceptive methods, abortion and emergency contraception are discussed. Primary health care centre and sexual and reproductive health clinic access is reinforced.
16009089|NCT02819375|Drug|Propofol|1 mg/kg propofol
16009090|NCT02819375|Drug|Propofol+Remifentanil|0.5 mg/kg propofol+0.5 mg/kg remifentanil
16009091|NCT02819375|Drug|Propofol+Ketamine|0.5 mg/kg propofol and 0.5 mg/kg ketamine
16009092|NCT02819362|Device|MRI|The magnetic resonance imaging (MRI) will be performed before the two-step surgery: a ductal-MRI sequence (highly weighted sagittal T2) - followed by sequence with axial plane, T2, T1, injection in dynamic sequences, subtractions.
16009093|NCT02819349|Behavioral|Texting for Relapse Prevention (T4RP)|T4RP is a relapse prevention mHealth program text messaging to people who have schizophrenia/SAD. Content is guided by components of the Assertive Community Treatment (ACT) and focuses on facilitating improved patient-provider communication, promoting medication adherence, helping people self-monitor their early warning signs, and promoting self-management of symptoms.
16009094|NCT02819336|Device|Electroacupuncture (EA)|"The EA group will receive the verum therapies using the following procedures.
~Let the patient lie down on lateral decubitus.
~The practitioners install the same guide-tubes as Park sham needle on CV2, CV3, CV4, CV6 and bilateral points of SP11 and SP6.
~The verum acupunctures are inserted on each acupoint inside the installed guide-tube. (stainless steel, 0.25 mm in diameter and 4.0 mm in length, Dong Bang Acupuncture Inc., Republic of Korea)
~After de qi response is elicited, the electrical stimulation is presented for 20 minutes by middle frequency (30 Hz). (STN-111, Stratek, Republic of Korea)
~The practitioner should have at least 1-year clinical experiences.
~The procedure will be repeated 10 times (once a session) within 21 days."
16009095|NCT02819336|Device|Sham electroacupuncture|"Let the patient lie down on lateral decubitus.
~The practitioners install the same guide-tubes as Park sham needle on CV2, CV3, CV4, and CV6 unilaterally & SP11 and SP6 bilaterally.
~The non-penetrating sham acupunctures are implemented on each acupoint inside the installed guide-tube.
~The electrical stimulation is presented for 20 minutes by middle frequency (30 Hz), (STN-111, Stratek, Republic of Korea) even though the electrical stimulation is not delivered through the skin because the needles are not penetrated through the skin.
~The practitioner should have at least 1-year clinical experiences.
~The procedure will be repeated 10 times (once a session) within 21 days."
16009096|NCT02819323|Drug|PEG-ELS|polyethylene glycol based bowel preparation
16009097|NCT02819323|Drug|BLI800|BLI800 bowel preparation
16009098|NCT02819310|Drug|BLI400 Laxative|oral laxative
16009099|NCT02819297|Drug|BLI400 Laxative|21 gm BLI400 powder
16009100|NCT02819297|Drug|BLI400 Placebo|Equivalent amount of placebo powder
16009101|NCT02819284|Drug|KPI-121 0.25% Ophthalmic Suspension|
16009102|NCT02819284|Drug|Vehicle of KPI-121 0.25% Ophthalmic Suspension|
16009103|NCT02819271|Drug|CXL-1427 Ascending Dose|
16009104|NCT02819271|Other|Placebo|
16009105|NCT02819271|Drug|CXL-1427 Descending Dose|
16009106|NCT02819258|Other|Endodontic treatment|
16009107|NCT02819245|Procedure|posterior correction and fusion|
16009108|NCT02819232|Other|Blood sampling|Detection of bacteria will be performed on a blood sample
16009109|NCT02819219|Dietary Supplement|Supplemental|participants were provided with either placebo, placebo + ElevATP, or placebo + ElevATP + Caffeine + Vitamins.
16009110|NCT02819219|Other|Exercise Intervention|Concurrent with the supplemental intervention, all subjects participated in a resistance exercise intervention.
16009111|NCT02819206|Other|Blood sampling|Detection of bacteria will be performed on a blood sample
16009112|NCT02819193|Other|raw mother's own milk|Infants receive mother's own milk before day 7.
16009113|NCT02819180|Biological|Butantan Influenza Trivalent, Fragmented and Inactivated vaccine|
16009114|NCT02819167|Other|neurologic and neuropsychological evaluation|cognitive prognosis, cognitive reserve, brain volume will be studied on patients with scale, questionnaire, magnetic resonance imaging
16009115|NCT02819154|Behavioral|phone call to evaluate the social changes, emotional, professional a cohort of patients following ICU stay|"phone call to evaluate the social changes, emotional, professional a cohort of patients following ICU stay. Investigators will use :
~Questionnaire SF 36: Only the first two questions of the SF-36 are used exploring the felt quality of life at the time of the telephone call and in comparison with the period before hospitalization in intensive care.
~Stress Assessment Questionnaire posttraumatic (Revised Impact of Event Scale, IES-R)
~ADL: Assessment of independence in activities of daily life"
16009116|NCT02819141|Drug|Dexmedetomidine|Patient will receive a maintenance intravenous infusion of medication (Dexmedetomidine) and have access to self-controlled sedation medication (Dexmedetomidine) for anxiety.
16009117|NCT02819128|Other|Swabs skin, pharyngeal, and blood sample|Collection of one blood sample with a volume of 10 mL (2 tubes of blood 5 mL ) and 2 swabs ( throat and skin ).
16009118|NCT02819128|Other|Collection of body lice|For the subjects infested with body lice , if they want, their underwear will be recovered and sent to the laboratory to measure the resistance to permethrin.
16009119|NCT02819115|Biological|Butantan Fragmented Inactivated Trivalent Influenza Vaccine|Butantan Fragmented Inactivated Trivalent Influenza Vaccine
16009120|NCT02819102|Drug|BCX7353 and probes|
16009121|NCT02819089|Drug|Dexmedetomidine|Demedetomidine infusion (2mcg/ml); loading 0.5 mcg/kg for 30 min (BW/2 ml/h for 30 min), then 0.5 mcg/kg (BW/4 ml/h) until 30 minutes before finish the operation.
16009122|NCT02819089|Other|NSS|NSS infusion; loading BW/2 ml/h for 30 min, then BW/4 ml/h until 30 minutes before finish the operation.
16009123|NCT02819076|Other|pain scale|
16009124|NCT02819050|Device|NCPAP|Nasal Continuous Positive Airway Pressure
16009125|NCT02819037|Procedure|gas chromatography|
16009126|NCT02819037|Procedure|Stool analysis for detection of malabsorption|
16009127|NCT02819024|Drug|Dexamethasone|Given PO BID
16009128|NCT02819024|Device|Device for PET|Undergo 18F-FLT PET scan
16009129|NCT02819024|Other|Laboratory Biomarker Analysis|Correlative studies
16009130|NCT02819024|Procedure|Positron Emission Tomography|Undergo 18F-FLT PET scan
16009131|NCT02819011|Device|MBB AFO|Subjects will be provided with a pair of New Balance 813 shoes plus a custom made MBB AFO
16009132|NCT02819011|Other|Control|Subjects will be provided with a pair of New Balance 813 shoes
16009133|NCT02818998|Drug|Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)|
16009134|NCT02818985|Drug|Dexamethasone|patients will receive intra-articular 8 mg dexamethasone added to 18 mL 0.25% bupivacaine into the knee joint.
16009135|NCT02818985|Drug|Dexmedetomidine|patients will receive intra-articular 1ug/kg dexmedetomidine added to 18 mL 0.25% bupivacaine into the knee joint.
16009136|NCT02818985|Drug|Saline|patients will receive intra-articular 18 mL 0.25% bupivacaine and 2mL isotonic saline into the knee joint.
16009137|NCT02818972|Device|RelayPro|Endovascular treatment with investigational device.
16009138|NCT02818959|Device|JenaValve Pericardial TAVR System|The JenaValve Pericardial TAVI system is intended for use in subjects with symptomatic severe aortic stenosis who are at high risk for surgical aortic valve replacement.
16009139|NCT02818946|Device|MRI|Detection of cancer by MRI for pathologic nipple discharge
16009140|NCT02818920|Drug|Pembrolizumab|"Pembrolizumab (prior to surgery) 200 mg IV over 30 min, days 1 & 22, two cycles; followed by surgery; followed by standard adjuvant chemotherapy (per med. oncologist) +/- radiation therapy per institutional standard of care; followed by adjuvant pembrolizumab 200 mg IV over 30 min every 21 days for 4 cycles
~-Note: Standard radiation therapy in selected patients for standard clinical indications"
16009141|NCT02818907|Other|Additional biological samples|blood and tumor tissue samples
16009142|NCT02818894|Drug|Lidocaine|Spinal anesthesia administered prior to participant's THA
16009143|NCT02818894|Drug|Bupivacaine|Spinal anesthesia administered prior to participant's THA
16009144|NCT02818881|Other|High-speed yoga|
16009145|NCT02818881|Other|Low-speed yoga|
16009146|NCT02818868|Drug|apixisaban|
16009147|NCT02818855|Procedure|Coronally advanced flap (CAF)|"The test group will be treated by means of the association of Collagen Matrix + Coronally Advanced Flap. As treatment, the control group will receive the association of a subepithelial Conjunctive Tissue Graft + Coronally Advanced Flap.
~The aim of both procedures will be to obtain root coverage. All these procedures will be performed in a standardized manner."
16009148|NCT02818855|Drug|Collagen Matrix|A new collagen membrane
16009149|NCT02818855|Procedure|Subepithelial connective tissue graft|Connective tissue graft
16009150|NCT02818842|Other|Primary Health Insurance Fund data|"Data collected are:
~First and last name of mother
~Age
~Mother's date of birth
~Theorical date of beginning of pregnancy
~Childbirth date"
16009151|NCT02818842|Other|Prenatal Diagnostic Center of Toulouse University Hospital data|"Data collected are :
~First and last name of the mother
~Mother's birth date
~Mother Obstetric history
~Course of pregnancy
~Drug exposure (name, decision period)
~Medical termination of pregnancy (date, cause ...)
~Malformations (description, test results, gender of the child,
~Weight, height and head circumference, American Pediatric Gross Assessment Record, neonatal pathology)."
16009152|NCT02818842|Other|Mother and child protection data collection|"Date collected are :
~Name and surname of Mother
~Date of birth of the mother
~Obstetric history of the mother (the first certificate to 8 days)
~Course of pregnancy (1st certificate to 8 days)
~Birth data (1 certificate to 8 days)
~Child gender,
~Age of the child at the time of the review,
~Weight, height and head circumference of the child
~American Pediatric Gross Assessment Record (1 certificate to 8 days)
~Neonatal diseases (1 certificate to 8 days)
~Birth defects (1 certificate to 8 days)
~Death (age at death)
~History (certificates at 9 and 24 months)
~Current diseases (certificates at 9 and 24 months)
~Psychomotor development (certificates at 9 and 24 months).
~Date of drugs issue
~Amount of drug issued
~Type of feeding (1 certificate to 8 days)"
16009153|NCT02818842|Other|Medicalisation Program of Information Systems data|"Data collected are :
~First and last name of the mother
~Mother's birth date
~History of abortions (date and cause)"
16009154|NCT02818829|Other|Collection of biological samples|Collection of biological samples including whole blood, serum, plasma, saliva, DNA and RNA from tumor cells, tissue from tumor biopsies, tissue from tumor and adjacent tissue of pancreas
16009155|NCT02818816|Drug|brimonidine tartrate 0.2%|Alpha adrenergic receptor agonist
16009156|NCT02818816|Other|Carboxymethylcellulose Eye Drops|Ocular lubricants
16009157|NCT02818803|Other|Propolis|
16009158|NCT02818803|Drug|Miconazole|
16009159|NCT02818790|Behavioral|Intervention 1|Bodyguard + Precious App. Short onsite training session on how to use the system.
16009160|NCT02818790|Behavioral|Intervention 2|Bodyguard + Precious App + Motivational Interviewing. Face to face counseling session followed by a short onsite training session on how to use the system.
16009161|NCT02818777|Drug|cannabidiol|"Purified CBD, is a strawberry flavored liquid, in sesame oil, provided as 100 mg/ml, extracted from high CBD plant material.
~A component of cannabis that has evidence suggesting it is relatively safe and perhaps neuroprotective, reduces tremor, anxiety and psychosis and is well tolerated in PD. Besides limiting the psychoactive effect of THC, studies support that CBD has anti-inflammatory, anticonvulsant, anti-oxidant, anxiolytic and antipsychotic properties."
16009163|NCT02818764|Procedure|Cerebral Spinal Fluid collection|Fluid collected at the time of dural puncture if patients will undergo spinal anesthesia
16009164|NCT02818764|Device|Electroencephalogram|Test used to detect abnormalities related to electrical activity of the brain will be done during surgery.
16009165|NCT02818764|Device|Cerebral blood flow and oxygen extraction fraction|NIRS measurement of Cerebral blood flow and cerebral tissue oxygen concentration.
16009166|NCT02818751|Drug|Escitalopram|Patients being randomized to receive escitalopram.
16009167|NCT02818751|Other|Placebo|Patients being randomized to receive placebo.
16009168|NCT02818738|Drug|Levamisole Hydrochloride|Dosage : 5, 10, 25 et 50 mg. Dosage form : oral tablets, coated and non dividable for taste-masking Posology : 2.5 mg/kg on alternate days maximum 150mg. Treatment duration : 6 months
16009169|NCT02818738|Other|Placebo|matching verum
16009170|NCT02818725|Drug|Chemotherapy|METHOTREXATE: 30 mg/m² on day 1 VINBLASTINE: 3 mg/m² on day 2 DOXORUBICIN: 30 mg/m² on day 2 CISPLATIN: 70 mg/m² on day 2
16009171|NCT02818725|Drug|Panitumumab|PANITUMUMAB: 6 mg/kg on day 2
16009172|NCT02818699|Dietary Supplement|Placebo|280mg placebo capsule containing only maltodextrin, twice daily, one with breakfast, one with dinner, for 12 weeks
16009173|NCT02818699|Dietary Supplement|EMIQ|280mg placebo capsule containing 180 mg EMIQ and 100mg maltodextrin, twice daily, one with breakfast, one with dinner, for 12 weeks
16009174|NCT02818686|Drug|TD-1473|
16009175|NCT02818686|Drug|Placebo|
16009176|NCT02818673|Radiation|labelled human serumalbumin (125-I, Séralb®CisBio)|Intra-veinous injection of 0,015 MBq/Kg ; 0,5 to 2 mL injected over less than a minute
16009177|NCT02818673|Radiation|labelled albumin (99m-Tc, Vasculocis®, Cisbio)|intra-peritoneal injection of 200 MBq of labelled albumin (99m-Tc, Vasculocis®, Cisbio) ; 5 ml injected over less than a minute
16009178|NCT02818660|Drug|Synachten|To stimulate the adrenals to increase the cortisol Production as much as possible
16009179|NCT02818647|Procedure|Tonsillectomy|Tonsillectomy is the name of the surgery where tonsils are removed via capsullary dissection. There are various techniques and its basically removing the tonsil from its tonsillary fossa and conducting hemostasis with various equipments.
16009180|NCT02818634|Procedure|Harvesting rib cartilage|
16009181|NCT02818621|Drug|Group Dex (dexmedetomidine)|1mcg/kg loading dose followed by 0.5mcg/kg/hr infusion of dexmedetomidine which was administered at induction of anesthesia through skin closure
16009182|NCT02818608|Device|Functional Electrical Stimulation (FES)|Functional Electrical Stimulation (FES) + Sham Transcranial direct brain stimulation (tDCS)
16009183|NCT02818608|Device|Combination of Transcranial direct brain stimulation (tDCS) and FES|Real Functional Electrical Stimulation (FES) + Real Transcranial direct brain stimulation (tDCS)
16009184|NCT02818595|Device|electroencephalogram (HR-EEG)|
16009185|NCT02818595|Device|Near Infra Red Spectroscopy (NIRS)|
16009186|NCT02818582|Drug|GS-5734|Daily GS-5734 or placebo delivered intravenously (IV) for 5 days
16009187|NCT02818582|Other|Placebo Comparator|Placebo delivered intravenously (IV) for 5 days.
16009188|NCT02818569|Drug|Dexmedetomidine|Oral form
16009189|NCT02818569|Other|Saline Placebo|Saline Placebo
16009190|NCT02818556|Drug|Restalyne Silk|
16009191|NCT02818556|Drug|Belotero Balance|
16009192|NCT02818543|Drug|LYC-30937|
16009193|NCT02818530|Device|IOP by tonometer|Electronic tonometer will be used as gold standard for intraocular pressure measurement in supine position after induction of anaesthesia and every 2 hours intraoperatively and at end of surgery.
16009194|NCT02818530|Device|Anterior chamber depth measurement by ultrasound|Anterior chamber depth will be measured by ultrasound in supine position after induction of anaesthesia and every 2 hours intraoperatively and at end of surgery.
16009195|NCT02818517|Other|ACE inhibitors|Evaluating the cardio toxicity effect of chemotherapy and radiation and estimating the effect of ACE inhibitors and beta blockers in the prevention of heart failure.
16009196|NCT02818517|Other|beta blockers|Evaluating the cardio toxicity effect of chemotherapy and radiation and estimating the effect of ACE inhibitors and beta blockers in the prevention of heart failure.
16009197|NCT02818504|Other|Wize Mirror|Interactive mirror which integrates contactless sensors and a touch screen interface to derive a semeiotic model of the face with reference to cardiometabolic risk in healthy subjects
16009198|NCT02818491|Drug|Placebo|Normal saline 0.9% in 2 mls
16009199|NCT02818491|Drug|Dexamethasone 1 mg|Dexamethasone 1 mg in 2 mls
16009200|NCT02818491|Drug|Dexamethasone 2 mg|Dexamethasone 2 mg in 2 mls
16009201|NCT02818491|Drug|Dexamethasone 3 mg|Dexamethasone 3 mg in 2 mls
16009202|NCT02818491|Drug|Dexamethasone 4 mg|Dexamethasone 4 mg in 2 mls
16009203|NCT02818491|Drug|Ropivacaine 0.5%|Ropivacaine 0.5% 20 mls
16009204|NCT02818478|Other|Reporting of patient reported outcome measures|Electronic reporting of patient reported outcome measures from home, compared to reporting of patient reported outcome measures at the outpatient clinic
16009205|NCT02818465|Other|Vascular calcifications by Xray|
16009206|NCT02818465|Other|Vascular calcifications by tomodentimetry|
16009207|NCT02818465|Biological|Blood sample withdrawn|
16009208|NCT02818452|Other|Oatmeal + OatWell28XF|Intervention involves consumption of one cereal in the beginning of each visit of the crossover sequence
16009209|NCT02818452|Other|Oatmeal|
16009210|NCT02818452|Other|Hot cereal|
16009211|NCT02818439|Other|evaluation of frailty|
16009212|NCT02818426|Drug|UCPVax|
16009213|NCT02818413|Other|Biospecimen collection and questionnaires|Biospecimen collection and questionnaires
16009214|NCT02818400|Procedure|composite tissue allotransplantation|
16009215|NCT02818387|Drug|Propofol|Propofol bolus dose administration according to the predetermined dose by biased coined design up-and-down study.
16009216|NCT02818387|Drug|Remifentanil|Remifentanil 0.125 mcg/kg/min infusion for 5 min before propofol administration.
16009217|NCT02818387|Drug|Midazolam|Remifentanil 0.125 mcg/kg/min infusion for 5 min before propofol administration followed by midazolam 0.015 mg/kg administration 1 min after remifentanil infusion start.
16009218|NCT02818374|Device|oral accessibility spatula (SAB)|
16009219|NCT02818361|Drug|Topical tripterygium gel|
16009220|NCT02818361|Drug|Placebo gel|
16009221|NCT02818348|Drug|darunavir/cobicistat|800/150 mg, once daily during 35 days + etravirine 400 mg, once daily during 14 days
16009222|NCT02818348|Drug|etravirine|400 mg, once daily during 28 days + darunavir/cobicistat 800/150 mg, once daily during 7 days
16009223|NCT02818335|Drug|LY3023414 Reference Fasted|Administered Orally
16009224|NCT02818335|Drug|LY3023414 Test Fasted|Administered Orally
16009225|NCT02818335|Drug|LY3023414 Test Fed|Administered Orally
16009226|NCT02818322|Device|telemedical monitoring ( T)|
16009227|NCT02818322|Device|classic monitoring|
16009228|NCT02818309|Drug|Lesogaberan|120 mg bid
16009229|NCT02818309|Drug|Placebo|Placebo
16009230|NCT02818296|Behavioral|Active IU CBM-I|
16009231|NCT02818296|Behavioral|Control CBM-I|
16009232|NCT02818283|Other|Soy Pretzel|Each packet (5oz.) of soy pretzel contains high gluten wheat flour, soy flour, soymilk, vegetable shortening, sugar, yeast, salt, and ascorbic acid. Each packet provides ~280 calories (16% fat, 54% total carbohydrates, and 30% protein).
16009233|NCT02818283|Other|Wheat Pretzel|Each packet (5oz.) of wheat pretzel contains high gluten wheat flour, vital wheat gluten, shortening, sugar, yeast, salt, and ascorbic acid. Each packet provides ~290 calories (16% fat, 54% total carbohydrates, and 30% protein).
16009234|NCT02818270|Drug|Salbutamol|Salbutamol (albuterol ) was delivered by a jet nebulizer with a 50 pis oxygen flow at 6 L/min.
16009235|NCT02818270|Drug|Acetylcysteine|Acetylcystine was delivered by a jet nebulizer with a 50 pis oxygen flow at 6 L/min.
16009236|NCT02818257|Other|Strip A|Adhesive strip A
16009237|NCT02818257|Other|Strip B|Adhesive strip B
16009238|NCT02818257|Other|Strip C|Adhesive strip C
16009239|NCT02818244|Device|Fit Bit Blaze Heart Rate Monitoring Device|
16009240|NCT02818244|Device|Garmin Forerunner 235 Heart Rate Monitoring Device|
16009241|NCT02818244|Device|Tom Tom Spark Cardio Heart Rate Monitoring Device|
16009242|NCT02818244|Device|Apple Watch Heart Rate Monitoring Device|
16009243|NCT02818244|Device|Scosche Rhythm + Heart Rate Monitor|
16009244|NCT02818231|Other|Brushing of the olfactory cleft|Non invasive sampling of olfactory cleft cells, by brushing under local anesthesia during fiberendoscopy Form: survey of acceptability
16009245|NCT02818218|Procedure|Liver Transplant|liver transplant recipient surgery
16009246|NCT02818205|Other|Sensory Challenge Protocol|Measurement of electrodermal activity in response to sensation
16009247|NCT02818179|Radiation|THERMOGRAPHY IMAGING|
16009248|NCT02818166|Procedure|Mitral valve surgery|Right mini-thoracotomy mitral valve replacement/repair.
16009249|NCT02818153|Other|Self questionnaire for allergic rhinitis control|
16009250|NCT02818140|Procedure|Ropivacaine TQL block|Unilateral ultrasound-guided TQL block with 30 mL ropivacaine 0.75% 30 min prior to the surgical procedure
16009251|NCT02818140|Procedure|Saline TQL block|Unilateral ultrasound-guided TQL block with 30 mL of saline 0,9% 30 min prior to the surgical procedure
16009252|NCT02818140|Drug|Ropivacaine|
16009253|NCT02818140|Drug|Saline|
16009254|NCT02818140|Device|Ultrasound|
16009255|NCT02818127|Procedure|coronary angiography|Coronary angiography will be performed by transfemoral or transradial approach in all patients. In order to evaluate each coronary artery, at least four views from the left and two views from the right system will be taken.
16009256|NCT02818114|Behavioral|Peer Enhanced Prolonged Exposure|Peer support interventions as adjunct to prolonged exposure
16009257|NCT02818101|Behavioral|Hypnosis session|
16009258|NCT02818088|Behavioral|n-Back (Cognitive Training)|
16009259|NCT02818075|Other|Mobile Phone Based Peer Support|Adolescents allocated to the experimental group will have access to all standard prenatal and postpartum community supports. In addition, mobile phone-based peer support (MPPS), which consists of support provided by a peer mentor via mobile phone (with both voice calling and Short Message Service text message capabilities) will be provided during pregnancy and for 12 weeks postpartum. Peer support is defined as a specific type of social support (informational, appraisal, and emotional support) that is provided by a peer mentor who possesses experiential knowledge of adolescent motherhood and is of similar age to the participant.
16009260|NCT02818075|Other|Usual Care|Participants allocated to the usual care group will not receive the peer support intervention but will have access to all standard community prenatal and postpartum support services such as 1) the Canada Prenatal Nutrition Program; 2) postpartum home visits / telephone support from a public health nurse; 3) postpartum appointments with midwives, obstetrician, family physician, and / or pediatricians, and 4) prenatal and postpartum support as needed from psychiatrists, psychologists, social workers, breastfeeding clinics, and community resources.
16009261|NCT02818062|Biological|Cytokines dosage in Aqueous humor|Specify details not covered in associated Arm Description.
16009262|NCT02818049|Procedure|Bronchoalveolar Lavage|BAL was performed in accordance with current practice. Patients are oxygenated with FiO2=1 at least 5 min before the start and 4 h after the procedure. Blood pressure, central venous pressure, heart rate and breathing are monitored by a monitor. O2 saturation (SpO2) is monitored continuously by pulse oximetry.
16009263|NCT02818036|Drug|Naltrexone|
16009264|NCT02818036|Drug|Placebo|
16009265|NCT02818023|Drug|Pembrolizumab|"Pembrolizumab will be given at a dose of 200 mg q3 weeks (this is the standard dosage, ). Treatment with pembrolizumab and vemurafenib will commence on the same day.
~One cycle of treatment will be defined as one dose of pembrolizumab and 3 weeks of vemurafenib."
16009266|NCT02818023|Drug|Vemurafenib|"Vemurafenib will be given at 480 mg twice daily, 720 mg twice daily, or 960 mg twice daily. Treatment with pembrolizumab and vemurafenib will commence on the same day.
~One cycle of treatment will be defined as one dose of pembrolizumab and 3 weeks of vemurafenib."
16009267|NCT02818023|Drug|Cobimetinib|Cobimetinib will be given at 20 mg once daily, 40 mg once daily, or 60 mg once daily. Treatment with cobimetinib will commence on the same day. Cobimetinib will be given daily for 21 days, then held for 7 days.
16009268|NCT02818010|Other|Global Physical Activity Questionnaire|The practice of physical activity is measured by the GPAQ 2 questionnaire (Global Physical Activity Questionnaire) developed by the World Health Organization.
16009322|NCT02817620|Dietary Supplement|Spirulysat®|
16009323|NCT02817620|Dietary Supplement|Placebo|
16009680|NCT02814968|Device|Whole body MRI|
16009269|NCT02817984|Biological|Acellular Adipose Tissue (AAT)|The components of the adipose-derived scaffold are all naturally occurring AAT proteins and proteoglycans that provide a natural scaffold. The nature of the AAT also enhances host tissue integration since matrix components can be easily degraded by cell-secreted enzymes as tissue remodeling takes place. Mechanisms for matrix turnover are already established in host cells, avoiding any concerns over proper clearance of scaffold materials from the body.
16009270|NCT02817971|Behavioral|Enhanced feedback|Hospital level feedback delivered every month through paediatrician on the level of adherence to revised pneumonia treatment recommendations.
16009271|NCT02817971|Behavioral|Standard feedback|Hospital level feedback delivered every two months through paediatrician on the performance of multiple paediatric care indicators for managing severely ill children.
16009272|NCT02817958|Drug|Chemotherapy TIP|Paclitaxel, ifosfamide, and cisplatin
16009273|NCT02817945|Drug|68Ga-NOTA-3P-TATE-RGD|68Ga-NOTA-3P-TATE-RGD were injected into the patients before the PET/CT scans
16009274|NCT02817932|Drug|Ranolazine|
16009275|NCT02817906|Drug|ITI-007|
16009276|NCT02817906|Drug|Placebo|
16009277|NCT02817880|Device|rTMS|
16009278|NCT02817880|Device|tDCS|
16009279|NCT02817880|Device|tsDCS|
16009280|NCT02817867|Device|tDCS|Transcranial direct current stimulation (tDCS)
16009281|NCT02817867|Device|TMS|Transcranial magnetic stimulation
16009282|NCT02817867|Device|tDCS + TMS|Association between tDCS and TMS.
16009283|NCT02817854|Procedure|Measure PCT, CRP and WBC at admission|Measure PCT, CRP and WBC at admission after diagnosis of acute diverticulitis with CT scan has been done
16009284|NCT02817854|Procedure|Measure PCT, CRP and WBC 1 day after admission|Measure PCT, CRP and WBC at one day after admission for acute diverticulitis
16009285|NCT02817854|Procedure|Measure PCT, CRP and WBC 2 days after admission|Measure PCT, CRP and WBC at 2 days after admission for acute diverticulitis
16009286|NCT02817841|Drug|15 mg E4/3 mg DRSP|15 mg estetrol and 3 mg drospirenone tablets administered once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
16009287|NCT02817828|Drug|15 mg E4/3 mg DRSP|15 mg estetrol and 3 mg drospirenone tablets administered once daily for 13 consecutive cycles following a 24/4-day regimen, i.e. one 15 mg E4/3 mg DRSP active tablet per day for 24 consecutive days followed by one placebo tablet per day for 4 consecutive days.
16009288|NCT02817815|Device|Electrocardiogram (ECG)|
16009289|NCT02817815|Biological|Blood sampling from the cephalic vein|
16009290|NCT02817815|Biological|Blood sampling from the femoral vein|Blood sampling will be done during radiofrequency ablation of AF procedure, after the introduction of catheter
16009291|NCT02817815|Biological|First blood sampling from left atrium|Blood sampling will be done during radiofrequency ablation of AF procedure, after transeptal punction
16009292|NCT02817815|Procedure|Atrial stimulation|Patients will receive atrial stimulation with the catheter positioned in the coronary sinus to induce AF
16009293|NCT02817815|Biological|Second blood sampling from left atrium|After 20min of continuous AF, a blood sampling from left atrium will be done
16009294|NCT02817802|Device|Magmaris|PCI (Magmaris)
16009295|NCT02817789|Drug|Ticagrelor alone|180 mg loading dose before intervention and 90 mg twice daily during 30 days after the procedure
16009296|NCT02817789|Drug|Combination lysine acetylsalicylate - clopidogrel|75 mg before and 75 mg daily after the procedure of lysine acetylsalicylate and 300mg loading dose before and 75 mg of clopidogrel daily after the procedure
16009297|NCT02817776|Device|THERMOCOOL SMARTTOUCH® SF catheter|Radiofrequency Ablation
16009298|NCT02817763|Procedure|Connective tissue graft (CTG)|Periodontal surgical technique to treat gingival recessions
16009299|NCT02817763|Procedure|CTG plus resin composite restoration|Periodontal surgical technique to treat gingival recessions Procedure/Surgery: Resin composite restoration Restorative procedure do treat tooth structure loss
16009300|NCT02817763|Drug|sodium dipyrone|sodium dipyrone was recommended for all participants after the surgical procedures.
16009301|NCT02817750|Drug|zolpidem hemitartarate tablet 3.5 mg (fasting + post-prandial)|zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting and zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial
16009302|NCT02817750|Drug|zolpidem hemitartarate tablet 3.5 mg (post-prandial + fasting)|zolpidem hemitartarate orodispersible tablet 3.5 mg postprandial and zolpidem hemitartarate orodispersible tablet 3.5 mg in fasting
16009303|NCT02817724|Device|BENECA System|BENECA System is a mobile application whit aims to recover a healthy lifestyle in breast cancer survivors (in terms of energy balance: physical activity and dietary).
16009304|NCT02817724|Other|Supervised-occupational therapy program|It is a comprehensive program that covers most of the physical, cognitive and emotional needs of these patients after oncology treatment from occupational therapy perspective.
16009305|NCT02817698|Drug|cannabis|All cannabis dependent subjects will use cannabis cigarettes to induce elevated dopamine and beta endorphin levels in the brain.
16009306|NCT02817685|Other|3 months|
16009307|NCT02817685|Other|6 months|
16009308|NCT02817685|Other|3 month ultrasound(US)+3 month CT/MRI+3 month US+3 month CT/MRI|
16009309|NCT02817672|Behavioral|PRIME 1.0|Mobile application designed to improve psychosocial functioning and motivational deficits (sans NLP-powered dashboard).
16009310|NCT02817672|Behavioral|PRIME 2.0|Mobile application designed to improve psychosocial functioning and motivational deficits (with NLP-powered dashboard).
16009311|NCT02817659|Drug|Glucagon|Glucagon infusion
16009312|NCT02817646|Other|Computed tomography scan made for clinical reasons|Patients were included if a computed tomography scan of the abdomen or thorax was made early during intensive care admission (1 day before up to 4 days after admission)
16009313|NCT02817646|Dietary Supplement|Nutrition as per hospital protocol|Patients received enteral and/or parenteral nutrition as per usual hospital protocol
16009324|NCT02817607|Procedure|Sensory testing and Biopsy|"Semmes-Weinstein testing: Each breast will be subdivided into 5 regions. This will include the upper 1/3rd, the middle 1/3rd medial and lateral to the nipple areola complex, the lower 1/3rd and the nipple areola-complex. These regions are consistent with the dermatomes described for the breast innervation.
~A cutaneous nerve/skin biopsy is a simple procedure commonly performed on an outpatient setting. The total procedure is expected to take 20 minutes and may be done at the time of surgery as well as 2 and 6 months post operatively either during a revision or at a follow up visit."
16009325|NCT02817568|Other|Drawing Blood|Drawing Blood for genetic analysis
16009326|NCT02817555|Drug|Epoetin Alfa|"The investigator will adjust epoetin doses as per the study algorithm during the run-in (every two weeks) and active phases (every four weeks). This will continue until the 12 month active phase is complete or the patient is withdrawn from the study.
~All epoetin will be administered intravenously through a hemodialysis machine port using a manufacturer-provided pre-filled syringe.
~It is not anticipated that a subject will require a dose of epoetin > 30 000 units weekly. If this occurs the dose will not be escalated any higher. Such a patient would likely meet the criteria for study withdrawal.
~Intravenous iron will be given as per the study algorithm and only one formulation of iron is used, sodium ferric gluconate."
16009327|NCT02817555|Drug|Darbepoetin alfa|"The investigator will adjust darbepoetin doses as per the study algorithm during the run-in (every two weeks) and active phases(every four weeks). This will continue until the 12 month active phase is complete or the patient is withdrawn from the study.
~All darbepoetin will be administered intravenously through a hemodialysis machine port using a manufacturer-provided pre-filled syringe.
~It is not anticipated that a subject will require a dose of darbepoetin >150µg weekly. If this occurs the dose will not be escalated any higher. Such a patient would likely meet the criteria for study withdrawal.
~Intravenous iron will be given as per the study algorithm and only one formulation of iron is used, sodium ferric gluconate."
16009328|NCT02817542|Device|percutaneous coronary intervention|Percutaneous coronary intervention. Procedures include: Implantation of stents The thrombus aspiration (TA) will be started before crossing the coronary atherosclerosis lesion. A minimum of two syringes (40 mL) of aspirate will be recommended. The guide catheter will be engaged with the coronary ostia when removing the thrombectomy catheter. The guide catheter will be aspirated after thrombectomy to avoid embolisation of air or thrombus. PCI procedure will be done without thrombectomy as per the investigator. Direct stenting will not be mandated in either treatment group. Bailout thrombectomy will be allowed after a failure of the initial PCI alone strategy. The decision about bailout thrombectomy will be made by the interventional cardiologist performing the initial PCI.
16009329|NCT02817529|Device|Pulmonica|The Pulmonica is a specially constructed and tuned Pulmonary Harmonica that produces deep, resonant, meditative sounds that can be felt vibrating in the lungs and sinuses. Participants who will be instructed to inhale and exhale through Pulmonica at least ten times daily for up to six months.
16009330|NCT02817529|Device|RC-Cornet|RC-Cornet is an oscillatory positive expiratory pressure device, which is designed to aid in the loosening and removal of mucus build-up in the lungs. Participants who will be instructed to inhale and exhale through RC-Cornet at least ten times daily for up to six months.
16009331|NCT02817516|Drug|TAK-828|TAK-828 solution.
16009332|NCT02817516|Drug|Placebo|TAK-828 placebo-matching solution.
16009333|NCT02817503|Drug|Standard BP control|Enalapril-folic acid will be used as an initial therapy. Other drugs, including CCB (amlodipine preferred), diuretics (hydrochlorothiazide preferred), and β-blockers, are allowed, in order to achieve the SBP target.
16009334|NCT02817503|Drug|Moderate BP control|Enalapril-folic acid will be used as an initial therapy. Other drugs, including CCB (amlodipine preferred), diuretics (hydrochlorothiazide preferred), and β-blockers, are allowed, in order to achieve the SBP target.
16009335|NCT02817503|Drug|Intensive BP control|Enalapril-folic acid will be used as an initial therapy. Other drugs, including CCB (amlodipine preferred), diuretics (hydrochlorothiazide preferred), and β-blockers, are allowed, in order to achieve the SBP target.
16009336|NCT02817490|Other|patient education program|"The PREDUSED patient education program aims to make the patient actor of his pathology by providing him a box of therapeutic tools in order to: improve his knowledge of the disease, improve the management of pain, fatigue and episodes of instability; learn to communicate about the disease; set realistic goals.
~The program includes theoretical information, practical cases, and discussions between participants and professionals.
~It is the first patient education program in France for the patients with hypermobility type Ehlers-Danlos Syndrome. It is proposed two times a year. Six patients can participate at each session."
16009337|NCT02817477|Drug|Ketamine Hydrochloride|Delivered intranasally using an atomizer
16009338|NCT02817477|Drug|Morphine|Delivered either as an IM injection or a slow IV bolus
16009339|NCT02817464|Drug|TV-46046 - 400 mg/mL|A single subcutaneous injection in the abdomen of TV-46046 - 400 mg/mL
16009340|NCT02817464|Drug|TV-46046 - 200 mg/mL|A single subcutaneous injection in the abdomen of TV-46046 - 200 mg/mL
16009341|NCT02817464|Drug|TV-46046 - 300 mg/mL (if warranted)|A single subcutaneous injection in the abdomen of TV-46046 - 300 mg/mL (if warranted)
16009342|NCT02817451|Biological|Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine|0.5 mL, Intramuscular at 6, 10, and 14 weeks of age + a booster at age 15 to 18 months
16009343|NCT02817451|Biological|Hexaxim®: DTaP-IPV-HB-PRP-T Combined Vaccine|0.5 mL, Intramuscular at 6, 10, and 14 weeks of age + a booster at age 15 to 18 months
16009344|NCT02817438|Behavioral|Good Days Ahead|Good Days Ahead is a web-based program based on the principles of Cognitive Behavioral Therapy (CBT). It can be used to supplement traditional psychotherapy, or as a stand-alone intervention. There are 9 lessons that address Thinking Skills, Behavioral Skills, Schemas, and Coping Tools. Lessons include videos from expert therapists and a Practice Section in which patients complete forms for self-monitoring symptoms and challenging negative thoughts.
16009345|NCT02817425|Drug|SOX Sequential S-1|8 cycles SOX followed by S-1 monotherapy until disease progression. S-1: 40 mg/m2 bid,po, day 1 ~14 (S-1：BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid) Oxaliplatin: 130 mg/m2 iv 2h,day 1.Every 21 days as a cycle.
16009346|NCT02817425|Drug|SOX|S-1: 40 mg/m2 bid,po, day 1 ~14 (S-1：BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid) Oxaliplatin: 130 mg/m2 iv 2h,day 1. Every 21 days as a cycle
16009546|NCT02815943|Other|liquid meal|will be consumed over 30 minutes with [U-13C]-palmitate (0.2 g mixed in the liquid meal) and H2-glucose
16009681|NCT02814968|Device|Bone scan|
16009347|NCT02817425|Drug|TEGAFOX Sequential S-1.|6 cycles TEGAFOX followed by S-1 monotherapy until disease progression. S-1: 40 mg/m2 bid,po, day 1 ~14 (S-1：BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid) Oxaliplatin: 130 mg/m2 iv 2h,day 1. TF 1000 mg/m2 with calcium folinate 300 mg/m2 IV infusion from Day 1 to Day 5 Every 28 days as a cycle.
16009348|NCT02817412|Behavioral|Go/No-Training|
16009349|NCT02817412|Behavioral|Stop-Signal Training|
16009350|NCT02817412|Behavioral|Dot-Probe Paradigm|
16009351|NCT02817412|Behavioral|Generic Response Training|
16009352|NCT02817399|Device|Functional electrical stimulation|Electrical stimulation that cause muscle contraction while walking
16009353|NCT02817399|Device|Neuro-muscular electrical stimulation|Electrical stimulation that cause muscle contraction in a stationary position
16009354|NCT02817399|Procedure|Active exercises|Subjects will receive training exercise according to ACL reconstruction protocol
16009355|NCT02817386|Other|interview|Trained clinical research assistants interviewed the patients on the first and second day post surgery. The interview included the Confusion Assessment Method (CAM) and MDAS. CAM is a diagnostic algorithm used to determine the presence or absence of delirium.
16009356|NCT02817373|Other|Ultrasound scan performed through a vaginal probe|5-8 minute scan recording : endometrial thickness, endometrial pattern, endometrial -myometrial junction appearance, subendometrial wave contractions (presence and number), endometrial surface area
16009357|NCT02817360|Drug|RAS-antagonist and beta-blocker up-to maximal dosages|All patients have to be stable on their glucose lowering, lipid lowering and blood pressure lowering therapy at least for 3 months. RAS-antagonist and beta-blocker therapy at entrance is allowed. Patients receive a prescription and/or up-titration to maximum recommended or tolerated dose of RAS-antagonist and beta-blockers within three months of study entry. The Number of titration visits is up to the treating physician, but one visit should be performed at least at the end of titration.
16009358|NCT02817360|Other|RAS-antagonist and beta-blocker none or at stable dose|All patients have to be stable on their glucose lowering, lipid lowering and blood pressure lowering therapy at least for 3 months. RAS-antagonist and beta-blocker therapy at entrance is allowed. Changes in RAS-antagonist or beta-blocker therapy are not allowed in the control group during the study phase. If there is a vital indication for changes, this has to be argued and documented.
16009359|NCT02817347|Drug|piperacillin 4% + tazobactam 0.5% + dexamethasone 0.1%|
16009360|NCT02817347|Drug|piperacillin 8% + tazobactam 1.0% + dexamethasone 0.1%|
16009361|NCT02817347|Drug|piperacillin 2% + tazobactam 0.25%|
16009362|NCT02817347|Drug|piperacillin 4% + tazobactam 0.5%|
16009363|NCT02817347|Drug|piperacillin 8% + tazobactam 1.0%|
16009364|NCT02817334|Drug|indocyanine green|As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.
16009365|NCT02817321|Procedure|single-injection TPVB + continuous TPVB|Inject local anesthetics in the T8 paravertebral space followed with catheter insertion and continuous local infusion.
16009366|NCT02817321|Device|Philip CX50 Ultrasound Scanner|The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scanning
16009367|NCT02817321|Device|PAJUNK Contiplex S Catheter|
16009368|NCT02817321|Drug|single dose ropivacaine|"2mg/kg ropivacaine in saline with 1:200,000 adrenaline, 25ml in total
~given immediately after the correct position of the tip of the needle has been confirmed"
16009369|NCT02817321|Drug|continuously infusion of ropivacaine|"0.2% ropivacaine, pulse dosadge: 0.125ml/kg/pulse, 1pulse/h at a rate of 6ml/minutes
~given through the catheter inserted in the T8 paravertebral space following the single dose"
16009370|NCT02817321|Drug|Morphine given as IPCA|bolus: 2mg, lock time: 10min, 1h limitation: 8mg
16009371|NCT02817308|Other|samples of blood, saliva and urine|Spot samples of Blood, urine and saliva
16009372|NCT02817295|Other|clinical measurements|follow up on the number of complications, revisions, hospitalization and co-morbidities
16009373|NCT02817282|Other|Hand hygiene implementation strategy|Implementation strategy: Individual oriented activities. Education based on the different determinants influencing HCWs' behavior. Reminders for supporting the actual performance of HH; by distributing posters. Performance feedback for awareness. Goal setting will be encouraged and the feedback will be used to help HCWs evaluate their success and determine how they could best adapt their behavior in order to reach their goal. Organisational oriented activities. Products and facilities: The physical environment will be adapted by improving the availability of hand based hand rub. Team-oriented activities; The social environment will be adapted by training at a group and individual level, to improve social and descriptive norms. Positive role models will be stimulated through this training.
16009374|NCT02817269|Other|Manual palpation|The manual palpation level will kept constant by applying enough digital pressure to cause the finger nail bed to blanch. When the nail will be turn pale, the amount of pressure will be measured at approximately 3 4kg/cm2 and will be maintained for 5-10 seconds to evoke referred pain. A manual palpation referred pain will be present if the pain radiated far enough for the patient to feel more than just a local pain.
16009375|NCT02817269|Other|Deep dry needling|Intramuscular needling will be carried out via deep dry needling into myofascial trigger point (MTrP) area without the introduction any substances. The aim is to elicit a local twitch response upon inserting the needle into the MTrP area and perform a neurological stimulation (by rotating the needle 360 degrees) to more easily evoke referred pain, holding for 10 seconds and then extracting the needle gently. The procedure will be followed by one minute of haemostatic compression.
16009376|NCT02817256|Dietary Supplement|Vitamins and Minerals|Multivitamins and Minerals supplementation
16009377|NCT02817243|Drug|SP2086|SP2086 will be administered orally (by mouth) as 100 mg on Days 4, 5, 6, 7, and 8 and Simvastatin will be administered orally as two 20mg tablets on Days 1 and 8. Both SP2086 and Simvastatin tablets will be taken with 8 ounces (240 mL) of water.
16009378|NCT02817243|Drug|Simvastatin|SP2086 will be administered orally (by mouth) as 100 mg on Days 4, 5, 6, 7, and 8 and Simvastatin will be administered orally as two 20mg tablets on Days 1 and 8. Both SP2086 and Simvastatin tablets will be taken with 8 ounces (240 mL) of water.
16009379|NCT02817230|Drug|Statin|
16009380|NCT02817217|Drug|SP2086|SP2086 will be administered orally (by mouth) as 100mg on Days 4, 5, 6, 7, and 8 and Valsartan will be administered orally as two 80mg tablets on Days 1 and 8. Both SP2086 and Valsartan tablets will be taken with 8 ounces (240 mL) of water.
16010307|NCT02810132|Drug|Metformin|See above
16009381|NCT02817217|Drug|Valsartan|SP2086 will be administered orally (by mouth) as100mg on Days 4, 5, 6, 7, and 8 and Valsartan will be administered orally as two 80mg tablets on Days 1 and 8. Both SP2086 and Valsartan tablets will be taken with 8 ounces (240 mL) of water.
16009382|NCT02817204|Behavioral|Aerobic Exercise|Cycle ergometer exercise for 3 sessions a day (3 minutes Warm up,45 minutes Resistance Exercise at 75% of HRmax;10 minutes Recovery). 5 days a week(about 2000kcal) and continues 12 weeks
16009383|NCT02817204|Behavioral|Health Education|Lower salt,fat and calorie diet,Recommendation of regular exercise,No smoking and alcohol
16009384|NCT02817191|Drug|Hylo-Comod eye drop|The patients were administrated Hylo-Comod eye drop four times a day after Phaco+IOL
16009385|NCT02817191|Drug|Tears Naturale Forte eye drop|The patients were administrated Tears Naturale Forte eye drop four times a day after Phaco+IOL
16009386|NCT02817178|Other|Additional biological samples|blood and tumor tissue samples
16009387|NCT02817165|Dietary Supplement|Probiotic (BioK+)|Probiotic (BioK+) with 3 stains of Lactobacillus
16009388|NCT02817165|Other|Placebo|Strawberry flavored tub of milk, identical (taste, color, odor) to the active Bio-K+ treatment.
16009389|NCT02817152|Procedure|Periodontal ultrasonic debridement|Periodontal pockets received periodontal ultrasonic debridement intervention.
16009390|NCT02817152|Device|Debridement plus low-level laser therapy|Ultrasonic debridement plus low-level laser therapy.
16009391|NCT02817139|Device|TDCS|
16009392|NCT02817126|Procedure|Robot-assisted resection|Arm I: Robot-assisted resection using da vinci system.
16009393|NCT02817126|Procedure|Laparoscopic resection|Arm II: Traditional laparoscopic resection.
16009394|NCT02817113|Drug|NC-6004|One cycle of treatment lasts for 3 weeks. NC-6004 will be administered over 1 hour on Day 1 (after the cetuximab infusion) every 3 weeks
16009395|NCT02817113|Drug|Cetuximab|One cycle of treatment lasts for 3 weeks. For each cycle, cetuximab will be administered at least 1 hour before the start of chemotherapy at a loading dose of 400 mg/m2 given over 2 hours initially (ie, on the first day of treatment), followed by a subsequent weekly doses of 250 mg/m2 over 1 hour.
16009396|NCT02817113|Drug|5-FU|One cycle of treatment lasts for 3 weeks. 5-FU will be administered at a dose of 1,000 mg/m2/day on Day 1- Day 4 as continuous infusion every 3 weeks.
16009397|NCT02817100|Drug|BAY1817080|Study part 1: Escalating doses of BAY1817080; single dose administration; solid dosage form (redosing of BAY1817080 at dose group 1 and 2 together with itraconazole; redosing of BAY1817080 at dose group 4 together with food [American breakfast]) Study part 2: Escalating doses of BAY1817080; single dose administration together with an American breakfast; solid dosage form (redosing of BAY1817080 at dose group 1, 2 and 4 together with food [Continental breakfast])
16009398|NCT02817100|Drug|Placebo|Study part 1: Escalating doses of respective placebos; single dose administration; solid dosage form (redosing of placebo at dose group 1 and 2 together with itraconazole; redosing of placebo at dose group 4 together with food [American breakfast]) Study part 2: Escalating doses of respective placebos; single dose administration together with an American breakfast; solid dosage form (redosing of placebo at dose group 1, 2 and together with food [Continental breakfast])
16009399|NCT02817100|Drug|Itraconazole|Redosing of BAY1817080/placebo at dose group 1 and 2 together with itraconazole (study part 1)
16009400|NCT02817087|Device|repetitive Transcranial Magnetic Stimulation -On|Cap worn on the scalp will deliver active Repetitive Transcranial Magnetic Stimulation to specific parts of the brain
16009401|NCT02817087|Device|repetitive Transcranial Magnetic Stimulation -Off|Cap worn on the scalp will no delivery of the Repetitive Transcranial Magnetic Stimulation to any part of the, referred to as a sham or inactive study treatment.
16009402|NCT02817074|Behavioral|MIND Diet|3-year dietary counseling to adhere to the MIND diet and for mild weight loss
16009403|NCT02817074|Behavioral|Mild Weight Loss|3-year dietary counseling to reduce calorie intake by 250 kcal/day for mild weight loss
16009404|NCT02817061|Device|Omnilux|The Omnilux LED array sources can be changed to emit different wavelength.
16009405|NCT02817048|Device|chest tube|
16009406|NCT02817048|Procedure|VATS without chest tube placement|Patient received Video-Assisted Thoracic Surgery (VATS) wedge resection for peripheral lung nodule without chest tube placement (Tubeless)
16009407|NCT02817048|Procedure|VATS with chest tube placement|
16009408|NCT02817035|Device|noninvasive mechanical ventilation|To examined the physiological signals of patients and healthy subjects during spontaneous breathing and noninvasive mechanical ventilation.
16009409|NCT02817022|Other|developmentally supportive care|DSC components will be strictly emphasized on protected sleep, pain and stress assessment and management, activities of daily living (positioning, feeding and skin care), the healing environment
16009410|NCT02817009|Behavioral|Social Support|The social worker for the parent support group addresses culturally specific questions and adopts culturally acceptable strategies for setting limits and promoting healthy behaviors, engaging the group as a whole and building peer support.
16009411|NCT02817009|Behavioral|Nutrition Session|Nutrition sessions will focus on how to make traditional Latin American foods healthier, including the sharing of recipes and learning what foods to buy in local supermarkets. Home visits by the nutritionist assists with family-centric strategies for healthier eating in their urban Latino households, including those with large extended families.
16009412|NCT02817009|Behavioral|Physical Activity Session|45 minutes physical activity session to promote healthy behaviors
16009413|NCT02816996|Procedure|Hand-holding|Subject will have their hand held.
16009414|NCT02816996|Procedure|Stress Ball|Subject will be given a stress ball to hold.
16009415|NCT02816983|Radiation|SBRT|
16009416|NCT02816970|Drug|Vildagliptin|1 tablet contains 50 mg vildagliptin
16009417|NCT02816970|Drug|Vildagliptin|1 tablet contains 50 mg vildagliptin
16009418|NCT02816957|Drug|nigella sativ|nigella sativa powder (2 gm/day) for 3 consecutive months.
16009419|NCT02816944|Procedure|EUS-guided laser ablation for refractory neoplasms|
16009452|NCT02816736|Drug|valsartan placebo|Valsartan placebo tablets will be supplied to match the low-dose (40mg) and high-dose (80mg) active valsartan tablets. Dosing for valsartan placebo will mirror dosing for active LCZ696 (the same number of low or high-dose tablets will be given.)
16009453|NCT02816723|Behavioral|Mindfulness-based Stress Reduction|mindfulness/meditation/movement training
16009454|NCT02816723|Behavioral|Brain Health|Brain Health Education
16009420|NCT02816918|Device|Extraluminal use of Univent bronchial Blocker|"Patients assigned to the Extraluminal use of Univent Blocker group were first inserted Univent bronchial Blocker into the glottis via direct laryngoscopy then advanced the Blocker to the target bronchus until slight resistance was encountered.A conventional tracheal tube with appropriate size was intubated via direct laryngoscopy into the appropriate depth, inflating the tracheal tube cuff, and fixing the tube firmly at the patient's mouth with cloth tape .
~So the Univent Blocker Extraluminal of the endotracheal tube,then the fibreoptic bronchoscopy was inserted into the tracheal tube and guided bronchial blocker cuff to the target main bronchus under direct vision"
16009421|NCT02816918|Device|Innerluminal use Univent bronchial Blocker|Patients in Innerluminal use of Univent Blocker group: When the endotracheal tube had been intubated via direct laryngoscopy, the bronchial blocker was advanced Innerluminal of the endotracheal tube and directed into the right or left mainstem bronchus, then the fibreoptic bronchoscopy was inserted into the tracheal tube. After further pushing and twisting, the bronchial blocker tube will move into the mainstem bronchus under direct vision by FOB.the tracheal tube cuff is inflated with the tube being fixed firmly at the patient's mouth with cloth tape
16009422|NCT02816905|Drug|0.1 % Dexamethasone|20 eyes are randomized to receive topical 0.1% Dexamethasone four times per day for 2 weeks.
16009423|NCT02816905|Drug|0.1% Fluorometholone|20 eyes are randomized to receive topical 0.1% Fluorometholone four times per day for 2 weeks.
16009424|NCT02816905|Drug|1% Rimexolone|40 eyes are randomized to receive topical 1% Rimexolone four times per day for 2 weeks. 20 of these eyes were the contralateral eyes of the patients who received 0.1% Dexamethasone in their first eye. The other 20 eyes were the contralateral eyes of the patients who received 0.1% Fluorometholone in their first eye
16009425|NCT02816879|Procedure|Cytology Specimen Collection Procedure|Undergo anal cytology collection
16009426|NCT02816879|Other|Laboratory Biomarker Analysis|Correlative studies
16009427|NCT02816866|Other|empowered primary care model|mode of survivorship care
16009428|NCT02816866|Other|specialty survivor clinic|mode of survivorship care
16009429|NCT02816853|Drug|Domperidone|Domperidone 10 mg or 20 mg tablets will be administered.
16009430|NCT02816853|Drug|Placebo|Matching placebo will be administered.
16009431|NCT02816853|Drug|Moxifloxacin|Moxifloxacin 400 mg tablet will be administered.
16009432|NCT02816840|Radiation|PET-CT|Patients in this arm take radiotherapy positioning with PET-CT.
16009433|NCT02816840|Radiation|PET-MRI|Patients in this arm take radiotherapy positioning with PET-MRI.
16009434|NCT02816827|Dietary Supplement|AG-01|Product to increase mental alertness
16009435|NCT02816827|Dietary Supplement|AG-05|Product to increase mental alertness
16009436|NCT02816827|Dietary Supplement|AG-06|Product to increase mental alertness
16009437|NCT02816827|Dietary Supplement|AG-07|Product to increase mental alertness
16009438|NCT02816814|Other|Diet rich in omega-3 fatty acids|A diet rich in omega-3 fatty acids (7g/die) will be administered for 4 months to overwieght women in menopause
16009439|NCT02816814|Other|Diet with extra virgin olive oil|A diet rich in EVO (25-30g/die) will be administered for 4 months to overwieght women in menopause
16009440|NCT02816801|Other|Butler-Program 2.0|Internet based intervention for elderly, in which they learn how to use e-mail, video conferencing and a blog, in addition to virtual relaxation exercises.
16009441|NCT02816788|Behavioral|Equine Assisted Therapy (EAT)|Psychotherapy incorporating use of equines (Equine Assisted Therapy; EAT) to facilitate therapy to improve the social, emotional and psychological well-being of participants and alleviate PTSD symptoms.
16009442|NCT02816775|Device|Macintosh Laryngoscope|After induction of anesthesia, tracheal intubation will made by Macintosh Laryngoscope
16009443|NCT02816775|Device|McGRATH Videolaryngoscope|After induction of anesthesia, tracheal intubation will made by McGRATH Videolaryngoscope
16009444|NCT02816762|Device|Continuous positive airway pressure|Nocturnal continuous positive airway pressure by a nasal mask. CPAP pressure will be automatically titrated using a AutoSet device (ResMed).
16009445|NCT02816762|Drug|Pharmacological treatment|Conventional pharmacological treatment with angiotensin converting enzyme inhibitors, angiotensin II receptor antagonists or anti-aldosterone agents.
16009446|NCT02816762|Other|Diet|Conventional anti-diabetic diet recommendations
16009447|NCT02816749|Procedure|Maggot debridement therapy|Participant will receive bio-bags treatment every 3 days until the wound heal completely, when wounds assessed.
16009448|NCT02816749|Procedure|Conventional Dressing Therapy|Participant will be disinfected by iodophor and dressed by gauze 3 days until the wound heal completely, when wounds assessed.
16009449|NCT02816736|Drug|LCZ696|"Subjects previously taking no or low-dose ACEI or ARB, or who have an eGFR < 30 mL/min/1.73m²: starting dose of LCZ696 = 50 mg po BID.
~Subjects taking an ARB at greater than low dose: starting dose of LCZ696 = 100 mg po BID.
~Subjects taking an ACEI at greater than low dose: starting dose of LCZ696 = 100 mg po BID.
~* At Investigator discretion, study drug may be started at the low dose if there are any concerns regarding tolerability.
~Dose adjustments will be performed every 2 weeks by doubling the dose of LCZ696 up to the target max dose of 200 mg po BID as tolerated.
~The doses of LCZ696 are 50mg (one low-dose (50mg) tablet), 100mg (one high-dose (100mg) tablet), and 200mg (two high-dose (100mg) tablets.) These doses are equivalent to 24/26 mg, 49/51 mg, and 97/103 mg commercial Entresto™, respectively."
16009450|NCT02816736|Drug|valsartan|"Subjects previously taking no or low-dose ACEI or ARB, or who have an eGFR < 30 mL/min/1.73m²: the starting dose of valsartan = 40 mg po BID.
~Subjects taking an ARB at greater than low dose: starting dose of valsartan = 80 mg po BID.
~Subjects taking an ACEI at greater than low dose: starting dose of valsartan = 80 mg po BID.
~* At Investigator discretion, study drug may be started at the low dose if there are any concerns regarding tolerability.
~Dose adjustments will be performed every 2 weeks by doubling the dose of valsartan up to the target maximum dose of 160 mg po BID, as tolerated.
~The doses of valsartan are 40mg (one low-dose (40mg) tablet), 80mg (one high-dose (80mg) tablet), and 160mg (two high-dose (80mg) tablets)."
16009451|NCT02816736|Drug|LCZ696 placebo|LCZ696 placebo tablets will be supplied to match the low-dose (50mg) and high-dose (100mg) active LCZ696 tablets. Dosing for LCZ696 placebo will mirror dosing for active valsartan (the same number of low or high-dose tablets will be given.)
16009496|NCT02816424|Behavioral|Teens Exploring and Managing Prevention Options (TEMPO)|
16009635|NCT02815332|Drug|BPX-01 Vehicle Topical Gel|Approximately 1 gram applied once daily for 12 weeks
16009455|NCT02816710|Drug|Conbercept|Conbercept is a humanized soluble fusion protein which has a high binding affinity to the Fc region of human immunoglobulin G1 simultaneously. Prior clinical studies have demonstrated that intravitreal conbercept (IVC) inhibits the process of angiogenesis in vivo and in vitro, and has been recognized as a novel effective treatment strategy for neovascularization, providing an alternative treatment option for ophthalmologists.
16009456|NCT02816697|Other|CEASE|"Clinical and Community Effort Against Secondhand Smoke Exposure (CEASE)
~CEASE is a system-level intervention that integrates tobacco-use screening, cessation assistance, and referral to outside services into routine visits"
16009457|NCT02816697|Other|Usual Care Tobacco Treatment Services|
16009458|NCT02816684|Behavioral|Pegasys-VR|Pegasys-VR uses artificially intelligent avatars and serious game technology to assist children in the acquisition and use of social skills.
16009459|NCT02816684|Behavioral|Social Effectiveness Therapy for Children|Group social skills training, peer generalization sessions, individual exposure therapy
16009460|NCT02816671|Device|Surgical Stapler|Patients in whom the MicroCutter stapler was used during a thoracic surgical procedure.
16009461|NCT02816658|Other|Laparoscopic Inguinal Hernia Repair|Laparoscopic Inguinal Hernia Repair
16009462|NCT02816658|Other|Robotic Inguinal Hernia Repair|Robotic Inguinal Hernia Repair
16009463|NCT02816645|Procedure|Magnetic Resonance Imaging (MRI)|
16009464|NCT02816632|Other|mRI|Neural bases of feedbacks' influence on decision making processes
16009465|NCT02816632|Other|Effect of Galvanic Vestibular Stimulation on decision making processes|Galvanic Vestibular Stimulation (GVS) stimulates the vestibular system through low intensity electric currents applied at the basis of the VIII cranial nerve, upon the mastoid processes. In the Right-Anodal condition the positive electric charge is applied through electrodes placed upon the right mastoid and it mainly activates structures within the left brain hemisphere. In the Left-Anodal condition the positive electric charge is applied through electrodes placed upon the left mastoid and it mainly activates structures within the right brain hemisphere. In the SHAM condition, low intensity electric currents are applied 5 cm below the mastoid processes. This condition does not activate the vestibular system and serves as a control condition to account for unspecific activating effects of all electric stimulations (e.g., arousal, discomfort). The three conditions will be applied in three different sessions (i.e. days) in randomized order.
16009466|NCT02816619|Behavioral|Personalized Physical Activity coaching program|
16009467|NCT02816619|Behavioral|Free practice of physical activity|
16009468|NCT02816606|Procedure|Flexible reamers|These reamers allow creation of the femoral tunnel to be made in reduced knee flexion and potentially maximise tunnel length
16009469|NCT02816606|Procedure|70-degree arthroscope|Using this arthroscope (rather than the more traditional 30-degree) gives improved visualisation of the femoral and tibial footprints. This may translate into better positioning of the tunnel within these regions
16009470|NCT02816593|Drug|hydrogen peroxide 6%|Office; hydrogen peroxide 6%, 3 sessions of 20 minutes of application
16009471|NCT02816593|Drug|hydrogen peroxide 15%|Office; hydrogen peroxide 15%, 3 sessions of 20 minutes of application
16009472|NCT02816593|Drug|Carbamide Peroxide 10%|Homemade; Carbamide Peroxide 10%, 2 hours per day for 21 days
16009473|NCT02816580|Other|Blood collection|
16009474|NCT02816567|Drug|propofol|
16009475|NCT02816567|Drug|NMBA - cisatracurium|
16009476|NCT02816567|Drug|placebo - isotonic saline serum|
16009477|NCT02816567|Drug|sufentanil|
16009478|NCT02816567|Procedure|laparoscopic surgery|
16009479|NCT02816554|Biological|JEVAX|JEVAX - VABIOTECH Vietnam Liquid form Subcutaneous injection 0.5ml/dose, 2 doses, 10-12 days interval
16009480|NCT02816554|Biological|JECEVAX-1|JECEVAX - VABIOTECH Vietnam Liquid form Composition: 1 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
16009481|NCT02816554|Biological|JECEVAX-0.8|JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.8 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
16009482|NCT02816554|Biological|JECEVAX-0.5|JECEVAX - VABIOTECH Vietnam Liquid form Composition: 0.5 BR209 Subcutaneous injection 0.5ml/dose, 2 doses, interval 10-12 days
16009483|NCT02816541|Other|Pelvis Retroverted|Pilates-based therapeutic exercises with the pelvis retroverted - Exercises executed with the retroverted pelvis, including the Footwork (toes, arched, heels, tendon stretch), Hundred, Coordination, Frog, Leg Circles (performed at the Universal Reformer apparatus ); Double Leg Stretch (performed at the Mat apparatus); Arm Spring Series (Performed at the Cadillac apparatus); The Wall Series (Performed at the Wall).
16009484|NCT02816541|Other|Pelvis in Neutral Position|Pilates-based therapeutic exercises with the pelvis in neutral position - Exercises executed with the retroverted pelvis, including the Footwork (toes, arched, heels, tendon stretch), Hundred, Coordination, Frog, Leg Circles (performed at the Universal Reformer apparatus ); Double Leg Stretch (performed at the Mat apparatus); Arm Spring Series (Performed at the Cadillac apparatus); The Wall Series (Performed at the Wall).
16009485|NCT02816541|Other|Aerobic exercise|Aerobic exercises (walking) performed on a treadmill.
16009486|NCT02816528|Behavioral|Training program|Physicians will be given informations regarding antibiotic consumptions and bacterial resistance in their activity area every 3 months during 12 months.
16009487|NCT02816502|Behavioral|Stress Management Skill Building Program A|Subject will meet with the instructor and other students in the group once a week and complete homework and track amount of practice during the week.
16009488|NCT02816502|Behavioral|Stress Management Skill Building Program B|Subject will meet with the instructor and other students in the group once a week and complete homework and track amount of practice during the week.
16009489|NCT02816489|Device|Clarity SL MBT brackets; 3M Unitek, Monrovia, CA, USA|(passive self-ligating ceramic orthodontic brackets with stainless steel archwire slot liner)
16009490|NCT02816489|Device|Gemini MBT brackets; 3M Unitek, Monrovia, CA, USA|(conventional stainless steel orthodontic brackets ligated with elastomeric ligature)
16009491|NCT02816476|Drug|Daratumumab|
16009492|NCT02816463|Device|Ambu AuraGain|
16009493|NCT02816463|Device|LMA Supreme|
16009494|NCT02816450|Behavioral|Water Intake|
16009495|NCT02816437|Biological|OpenBiome Fecal Microbiota Transplantation retention enema|Keep enema frozen until ready for administration. A single transfer of all 250mL of fecal material using universal precautions to a standard retention enema bag over 1 hour with material retained for at least 1 hour.
16009497|NCT02816411|Dietary Supplement|Milk protein isolate|"Milk protein isolate in a powder form consisted of 80% casein and 20% whey protein. 20g were diluted into 500 ml water.
~Placebo consisted of 365 ml water, 125 ml sugar-free cordial and 2g of low-calorie glucose/dextrose powder."
16009498|NCT02816411|Dietary Supplement|Placebo|500 mL drink that contained water (375 mL), sugar-free cordial (125 mL) and 2 g of low-calorie glucose/dextrose powder.
16009499|NCT02816398|Device|Percutaneous creation of an arteriovenous fistula|Use of catheter system for percutaneous creation of an arteriovenous fistula
16009500|NCT02816385|Procedure|Antegrade cardioplegia|Injection of the cardioplegia in the coronary arteries
16009501|NCT02816385|Procedure|Retrograde cardioplegia|Injection of the cardioplegia in the venous system
16009502|NCT02816372|Other|Tidal volume reduction to 4 ml/kg Predicted Body Weight (PBW)|Tidal volume reduction to 4 ml/kg predicted body weight from inclusion to weaning PEEP trial
16009503|NCT02816359|Other|head-bed position|Head-bed position at 0° for 30 minutes then head-bed position at 30° for 30 minutes
16009504|NCT02816346|Biological|Shigella sonnei 53G|"Investigational Product: Shigella sonnei strain 53G (Lot 1794) Mode of Administration: Delivered with sodium bicarbonate orally after a 90 minute fast.
~Dose: 500-1500 cfu (doses were to be increased or lowered based on results of preceding cohorts)"
16009505|NCT02816320|Other|Hospitalization|Patients who were hospitalized in acute care
16009506|NCT02816307|Other|blood samples|
16009507|NCT02816294|Behavioral|Housing Prescription|
16009508|NCT02816268|Other|Pulmonary vein isolation|
16009509|NCT02816255|Device|Full Face Mask with same CPAP Pressure|Full Face Mask with same CPAP Pressure
16009510|NCT02816255|Device|Full Face Mask with new Pressure|New cpap pressure derived from our formula for the final two weeks.
16009511|NCT02816242|Other|concept map teaching|teaching anatomy using concept map to improve critical thinking
16009512|NCT02816242|Other|traditional teaching|teaching anatomy using lecture
16009513|NCT02816229|Device|Insertion of endobronchial valve|One or more endobronchial one- way valves will be inserted into the appropriate lung regions
16009514|NCT02816216|Behavioral|CampAir|An empirically-based dynamic e-health intervention (based on the evidence-based ASMA) to assist adolescents with uncontrolled asthma to learn how to manage their illness and improve their asthma control.
16009515|NCT02816203|Device|Hemostatic Intra-Uterine suction cup|The hemostatic intra-uterine suction cup is introduced to the uterine cavity and a negative pressure is applied into the device.
16009516|NCT02816190|Procedure|prone position|
16009517|NCT02816177|Other|Telemedicine|
16009518|NCT02816177|Other|Usual Care|
16009519|NCT02816164|Drug|Neupogen|Subcutaneous injections
16009520|NCT02816151|Drug|full dose at 16 UI/kg for Dysport or 6,5 UA/kg for Botox|Intradetrusor injection under general anesthesia. Injection done through 25 points of 1cc each.
16009521|NCT02816151|Drug|half dose at 8 UI/kg for Dysport or 3,25 UA/kg for Botox|Intradetrusor injection under general anesthesia. Injection done through 25 points of 1cc each.
16009522|NCT02816138|Drug|Nicotine|Open-label transdermal nicotine patch
16009523|NCT02816125|Dietary Supplement|omega-3 fatty acid|SEE YOURSELF WELLTM OMEGA-3 Dietary Supplement: See Yourself Well Inc., Leamington, Ontario) containinged 200 mg of EPA and 100 mg of DHA for a total of 1.2 g n-3/day.
16009524|NCT02816112|Drug|Ciprofloxacin|Antibiotic
16009525|NCT02816112|Drug|Neupogen|Granulocyte-colony stimulating factor
16009526|NCT02816099|Biological|Prise de sang|
16009527|NCT02816086|Other|Interdisciplinary collaboration structure|A pharmacist is integrated in the team surrounding the patient, working by the Integrated Medicines Management (IMM) model. The IMM-model consist of medication reconciliation, medication review, standardized medication reports and counseling patients about their medication at discharge. In addition a phone meeting between the primary care physician and the study pharmacist is added after discharge.
16009528|NCT02816073|Device|Pan-retinal photocoagulation using pattern scanning laser|Patients receive the designated number of laser shots of pan-retinal photocoagulation with pattern scanning laser in a single session
16009529|NCT02816060|Procedure|manual therapy|manual therapy with neural exercise will be applied on patients with neck pain
16009530|NCT02816047|Other|Registry|Observational study to describe WCD indications, event rates, inappropriate shock rates and follow up (including ICD rate, shock rate, morbidity and mortality) in all Austrian WCD patients
16009531|NCT02816034|Behavioral|Visuo-motor rotation|Participant moves a cursor on a screen by sliding a pen over a digital tablet. Participants perform a center-out movement, aiming to a target that appears over one of a set of eight markers radially distributed. In several block of trials, the mapping of the pen position to the cursor is rotated.
16009532|NCT02816034|Behavioral|Explicit strategy|Participant is provided with an explicit instruction as to how counteract the effects of the visuo-motor rotation via aiming to a marker adjacent target
16009533|NCT02816021|Drug|Azacitidine|300 mg by mouth daily for 15 days (Days 1-15) of every cycle.
16009534|NCT02816021|Drug|Pembrolizumab|200 mg by vein every 3 weeks and after the oral dose of Azacitidine on concurrent treatment days.
16009535|NCT02816008|Behavioral|Cognitive rehabilitation training with RGS in the clinic|Daily cognitive training with the Rehabilitation Gaming System (RGS) in the clinic during 6 weeks (5 days per week a 30 minutes).
16009536|NCT02816008|Behavioral|Passive/conventional cognitive training at home.|Daily conventional cognitive rehabilitation at home as recommended by the neurologist during 6 weeks (5 days per week a 30 minutes).
16009537|NCT02815995|Drug|Durvalumab|Age group ≥ 18: Durvalumab 1500 mg by vein every 4 weeks for 4 cycles. After Week 16, participant may continue to receive durvalumab alone by vein for an additional 32 weeks (8 doses).
16009538|NCT02815995|Drug|Tremelimumab|Age group ≥ 18: Tremelimumab 75 mg every 4 weeks for 4 cycles.
16009539|NCT02815982|Behavioral|NOURISH-T|Overweight/obesity family intervention
16009540|NCT02815982|Behavioral|Enhanced Usual Care|Publicly available overweight/obesity materials
16009541|NCT02815969|Other|vena punction|vena punction and urine collection
16009542|NCT02815956|Device|percutaneous tibial nerve stimulation|
16009543|NCT02815956|Device|Placebo|
16009544|NCT02815943|Procedure|biliopancreatic diversion with duodenal switch|
16009545|NCT02815943|Procedure|sleeve gastrectomy|
16009547|NCT02815943|Radiation|PET/scan|a dynamic and whole body PET acquisition will be performed on a thoraco-abdominal segment, 150 minutes after an oral administration of 18FTHA
16009548|NCT02815943|Other|[7,7,8,8-2H]-palmitate|i.v. administration of [7,7,8,8-2H]-palmitate (in 25% human albumin) from time -60 to 360 min.
16009549|NCT02815943|Device|indirect calorimetry|will be performed every hour throughout the protocol along with exhaled breath collection
16009550|NCT02815930|Other|HCU Status|Total healthcare expenditures in the top 5% of Ontarians
16009551|NCT02815917|Drug|[18F]FTP PET/CT|All PET/CT imaging sessions will include an injection of [18F]FTP. Pilot data will be collected to evaluate preliminary information on brain uptake of [18F]FTP in healthy volunteers and cocaine-dependent volunteers.
16009552|NCT02815904|Other|Yakson touch|Yakson is a Korean therapeutic touch given to neonates and infants by caressing their abdomen with one hand while the other hand is placed on the back of the neonate\infant to relieve their pain or to calm them down.
16009553|NCT02815904|Other|Conventional handling|Positioning of preterm infants for optimal physiological development
16009554|NCT02815904|Other|Kinesthetic stimulation|For kinesthetic stimulation, all the limbs were given six passive flexion and extension movements
16009555|NCT02815904|Other|Kangaroo Mother Care|Providing skin to skin human touch
16009556|NCT02815878|Behavioral|Enhance Wellness|A 6-month health promotion intervention which pairs participants with a wellness coach to identify and pursue a health-related goal of their choosing.
16009557|NCT02815865|Device|Foley catheter and pitocin|Foley catheter will be inserted through the cervix and inflated with 80 ml saline, pitocin will be initiated 1 hour later in the delivery room
16009558|NCT02815865|Device|Foley catheter and Dinoprostone|Foley catheter will be inserted through the cervix and inflated with 80 ml saline Dinoprostone 3 mg will be inserted 1 hour later to the posterior fornix
16009559|NCT02815865|Drug|Dinoprostone|Dinoprostone 3 mg will be inserted to the posterior fornix
16009560|NCT02815852|Other|Women under 40 years old with histological diagnosis of breast cancer|Evaluation of imaging characteristics (ultrasound, mammography and mammary MRI if available) of breast cancer with the corresponding histological reports and assess whether in women <40 years the typical imaging presentation pattern of malignancies observed in women> 40 years are confirmed.
16009561|NCT02815839|Drug|SHR4640|
16009562|NCT02815839|Drug|Placebo|
16009563|NCT02815826|Other|Barefoot training|During 16 weeks, habitual shod runners kept their normal running training routine (wearing shoes), while they were introduced progressively to BF condition. Three training sessions were performed per week. Barefoot training started with 5% and ended with 20% of their WTV being performed without shoes. Soft surfaces (i.e. sand and grass) were adopted in the beginning of training (week 1 to 8). From week 9 to 16, participants mixed soft with harder surfaces, as treadmill and asphalt, to accomplish the training.
16009564|NCT02815826|Other|Shod training|Running training planned individually to each runner, according to their physical fitness, and performed with shoes.
16009565|NCT02815813|Behavioral|PeerFIT|The 12-month PeerFIT intervention consists of a 6-month intensive phase including: (a) once weekly 60-minute group weight management and exercise session led by a lifestyle coach; (b) once weekly one-hour physical activity session delivered in community settings; and (c) Facebook and mHealth technology (i.e., Fitbits, text messaging support) to increase motivation and facilitate self-monitoring and peer social support for health behavior change. Participants then transition to a 6-month lower intensity phase in which the 90-minute weight management sessions are discontinued. The groups will be conducted as open groups with a minimum of 4 and maximum of 18 participants at any given time.
16009566|NCT02815813|Behavioral|BEAT|Participants in BEAT will receive monthly individual lifestyle sessions delivered by a lifestyle coach including education, guidance, and support for self-monitoring behaviors (i.e., daily self-weighing and tracking daily steps) during the first six months of the study, plus text message reminders and encouragement for self-monitoring weight loss behaviors during the entire 12-month study period. Participants will receive materials with tips and strategies for healthy eating and increasing physical activity. They will also be given a wearable activity tracker (i.e., Fitbit Zip) to use with instructions for using the device. The first session with the lifestyle coach will be in person and thereafter by phone.
16009567|NCT02815800|Dietary Supplement|ETHNODYNE VISIO|
16009568|NCT02815787|Drug|SP2086|In the A sequence Glyburide was taken at 5mg qd dose on Days1,4,5,6,7 and 8; SP2086 will be administered orally (by mouth) as 200mg on Days 8.In the B sequence was that SP2086 was taken at 200mg qd dose on Days1,4,5,6,7 and 8;Glyburide will be administered orally (by mouth) as 200mg on Days 8.
16009569|NCT02815787|Drug|Glyburide|In the A sequence Glyburide was taken at 5mg qd dose on Days1,4,5,6,7 and 8; SP2086 will be administered orally (by mouth) as 200mg on Days 8.In the B sequence was that SP2086 was taken at 200mg qd dose on Days1,4,5,6,7 and 8;Glyburide will be administered orally (by mouth) as 200mg on Days 8.
16009570|NCT02815774|Drug|SP2086|all subjects were given SP2086 50mg only one time.
16009571|NCT02815761|Other|NO intervention, just observation|No intervention.
16009572|NCT02815748|Drug|SP2086|SP2086 was taken only one time at 100mg dose in health volunteers
16009573|NCT02815735|Device|comfilcon A|contact lens
16009574|NCT02815735|Device|lotrafilcon B|contact lens
16009575|NCT02815722|Drug|SP2086|The A sequence was that SP2086 was taken at 200mg qd on Days1-Day10; Simvastatin will be administered orally (by mouth) as 40mg on Days 6-Day10.The B sequence was that Simvastatin was taken at 40mg qd dose on Days 6-Day10.
16009576|NCT02815722|Drug|Simvastatin|The A sequence was that SP2086 was taken at 200mg qd on Days1-Day10; Simvastatin will be administered orally (by mouth) as 40mg on Days 6-Day10.The B sequence was that Simvastatin was taken at 40mg qd dose on Days 6-Day10.
16009577|NCT02815709|Drug|Oliceridine|
16009578|NCT02815709|Drug|Placebo|
16009579|NCT02815709|Drug|Morphine|
16009580|NCT02815696|Device|Magnetic Resonance Imaging|Specific MRI sequences (delayed gadolinium-enhanced magnetic resonance imaging of cartilage -dGEMRIC) performed before the surgery, 6 months and 1 year after surgery will allow to measure the following parameters: disc height, total lumbar spine lenght, GAGs concentration.
16009581|NCT02815670|Drug|Idarucizumab|
16009582|NCT02815657|Drug|SP2086|The A sequence was that Valsartan was taken at 160mg qd on Days1-Day12; SP2086 will be administered orally (by mouth) as 200mg on Days 8-Day12.The B sequence was that SP2086 was taken at 200mg qd dose on Days 8-Day12
16009583|NCT02815657|Drug|Valsartan|The A sequence was that Valsartan was taken at 160mg qd on Days1-Day12; SP2086 will be administered orally (by mouth) as 200mg on Days 8-Day12.The B sequence was that SP2086 was taken at 200mg qd dose on Days 8-Day12
16009584|NCT02815644|Drug|empagliflozin/linagliptin FDC|empagliflozin/linagliptin fixed-dose combination (FDC) film-coated tablet
16009585|NCT02815631|Device|Cardiogoniometry (CGM)|
16009586|NCT02815631|Device|Fractional Flow Reserve (FFR)|
16009587|NCT02815618|Device|BabyLux Neuro-monitor|Measurement of cerebral blood flow index (CBFi) and tissue oxygen saturation (StO2).
16009588|NCT02815592|Drug|BMS-986012|
16009589|NCT02815592|Drug|Cisplatin|
16009590|NCT02815592|Drug|Etoposide|
16009591|NCT02815592|Drug|Platinum|
16009592|NCT02815592|Drug|Carboplatin|
16009593|NCT02815579|Other|Shamba Maisha Intervention|A) A microcredit loan (~$140) B) Agricultural implements to be purchased with the loan C) Education in financial management and sustainable farming practices
16009594|NCT02815566|Drug|tenofovir-alafenamide-emtricitabine|comparison of tenofovir-emtricitabine and tenofovir-alafenamide-emtricitabine on bone mineral density
16009595|NCT02815566|Drug|tenofovir-emtricitabine|comparison of tenofovir-emtricitabine and tenofovir-alafenamide-emtricitabine on bone mineral density
16009596|NCT02815553|Procedure|Direct Transthoracic Cardiac Tumor Radio Frequency Ablation Therapy|
16009597|NCT02815553|Procedure|Direct Transthoracic Cardiac Tumor Laser Ablation Therapy|
16009598|NCT02815540|Procedure|12-Lead ECG|Subjects will be monitored while on cannabidiol with a 12-Lead ECG and/or Holter monitoring
16009599|NCT02815540|Drug|Cannabidiol|Subjects who are planning to take state dispensed medical cannabidiol, or are already taking state dispensed medical cannabidiol.
16009600|NCT02815527|Other|Fresubin intensive|Enteral nutrition containing a high protein concentration
16009601|NCT02815501|Biological|blood samples|for the determination of thyroid hormones (TSH, FT3, FT4 ) and antibodies against the thyroid (anti TPO antibodies and anti thyroglobulin)
16009602|NCT02815488|Drug|CHF6297 (Part 1 - SAD)|Single doses of CHF6297 at each period (for up to 3 periods per subject)
16009603|NCT02815488|Drug|Placebo (Part 1 - SAD)|Single doses of placebo matching CHF6297 at each period (for up to 3 periods per subject)
16009604|NCT02815488|Drug|CHF6297 (Part 2 - MAD)|Twice daily doses of CHF6297 for 7 days
16009605|NCT02815488|Drug|Placebo (Part 2 - MAD)|Twice daily doses of placebo matching CHF6297 for 7 days
16009606|NCT02815488|Drug|CHF6297 (Part 3)|Twice daily doses of CHF6297 for 14 days
16009607|NCT02815488|Drug|Placebo (Part 3)|Twice daily doses of placebo matching CHF6297 for 14 days
16009608|NCT02815488|Drug|CHF6297 (Part 4)|Twice daily doses of CHF6297 for 7 days
16009609|NCT02815488|Drug|Placebo (Part 4)|Twice daily doses of placebo matching CHF6297 for 7 days
16009610|NCT02815475|Dietary Supplement|Placebo comparator|
16009611|NCT02815475|Dietary Supplement|Curcumin|
16009612|NCT02815475|Dietary Supplement|Turmeric powder|
16009613|NCT02815462|Other|FAMFACESG|- PNs will receive the FAM-FACE-SG FA risk scores for frequent admitters admitted to their ward.
16009614|NCT02815462|Other|Control|- Usual hospital Care
16009615|NCT02815462|Other|FAMFACESG|- PNs will be instructed to prioritize intervention of frequent admitters for intervention based on the FA risk score.
16009616|NCT02815462|Other|FAMFACESG|"For high and moderate risk patients who do not require transitional home care (THC), PN will do the case management and follow up.
~For high and moderate risk patients & have complex nursing and / or high functional needs, PNs will refer these patients for THC.
~For mild risk patients, PNs will refer them to care coordinator."
16009617|NCT02815462|Other|FAMFACESG|- For low risk patients, PNs will continue usual hospital care.
16009618|NCT02815449|Other|Meals prepared with iron fortified cube with Low stabilizer level|Meals prepared with iron fortified cube with Low stabilizer level
16009619|NCT02815449|Other|Meals prepared with iron fortified cube with Medium stabilizer level|Meals prepared with iron fortified cube with Medium stabilizer level
16009620|NCT02815449|Other|Meals prepared with iron fortified cube with High stabilizer level|Meals prepared with iron fortified cube with High stabilizer level
16009621|NCT02815436|Other|Telephone reminder|a personal, interactive telephone reminder by a centre colleague to remind return to the centre for taking faecal tubes for screening
16009622|NCT02815436|Other|SMS reminder|a one-way, SMS message sent from the centre to the screening participant's mobile phone
16009623|NCT02815423|Biological|UCMSCs|Transplatation of umbilical cord mesenchymal stem cells
16009624|NCT02815423|Biological|Percutaneous|Percutaneous injection
16009625|NCT02815410|Drug|levetiracetam|Patients in this group are with newly diagnosed glioblastoma patients who are supposed to be treated with concurrent chemoradiotherapy (CCRT) and adjuvant chemotherapy with temozolomide (TMZ). Patients ( intervention Group) will be given levetiracetam (LEV) from the beginning of treatment till after the adjuvant chemotherapy with TMZ is over.
16009626|NCT02815397|Drug|Metformin|given in addition to standard of care treatment
16009627|NCT02815371|Procedure|Needle Acupuncture|See above
16009628|NCT02815371|Procedure|Laser Acupuncture|See above
16009629|NCT02815371|Procedure|Sham Laser Acupuncture|See above
16009630|NCT02815358|Other|Segmental Stabilization Exercises|The stabilization program focuses on the reestablishment of motor control and coordination between deep and superficial trunk muscles. The exercise program is based on the following criteria progression: 1) Precise contraction of the transverse abdominal and multifidus muscles, keeping the lumbar spine in a neutral position (as the middle way between maximum flexion and extension, repeated three times); 2) Keep the neutral position for 10 repetitions of 10 seconds; 3) Perform exercises with lower limbs in different postures.
16009631|NCT02815358|Other|Home Exercises|Home exercises include passive stretching and active mobilization of the spine.
16009632|NCT02815345|Device|Rhinometry|An acoustic rhinometry device will be used to evaluate the area and the volume of the nasal cavities. Both nasal cavities will be measured except for patients with nasogastric tube.
16009633|NCT02815332|Drug|BPX-01 1% Minocycline Topical Gel|Approximately 1 gram applied once daily for 12 weeks
16009634|NCT02815332|Drug|BPX-01 2% Minocycline Topical Gel|Approximately 1 gram applied once daily for 12 weeks
16010308|NCT02810132|Drug|Placebo|See above
16009637|NCT02815306|Device|Polyaxial brace|The Polyaxial brace were made by a technician trained by the China National Disabled Persons Federation. For all patients, gypsum models were prepared first, and then braces were fabricated according to the models. The detailed technique was fully in accordance with the Ponseti method.
16009638|NCT02815293|Drug|AGN-195263|1 drop of AGN-195263 will be instilled in each eye twice daily.
16009639|NCT02815293|Drug|Vehicle|1 drop of AGN-195263 vehicle (placebo) will be instilled in each eye twice daily.
16009640|NCT02815280|Drug|FMX-101, 4% minocycline foam|FMX-101, 4% minocycline foam applied topically once daily for 12 weeks
16009641|NCT02815280|Drug|Vehicle Foam|Vehicle foam applied topically once daily for 12 weeks
16009642|NCT02815267|Drug|FMX-101, 4% minocycline foam|FMX-101, 4% minocycline foam applied topically once daily for 12 weeks
16009643|NCT02815267|Drug|Vehicle Foam|Vehicle foam applied topically once daily for 12 weeks
16009644|NCT02815254|Other|High intensity functional exercise|
16009645|NCT02815254|Other|Low intensity functional exercise|
16009646|NCT02815241|Drug|BAY987517|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z43-046)
16009647|NCT02815228|Drug|BAY987517|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z43-034)
16009648|NCT02815215|Procedure|Minimally Invasive Carroll's Technique|Patient will be treated with minimally invasive Carroll's technique by 3 small incisions in the heel, in the medial side of the foot and in the planta pedis, respectively. Long-leg plaster cast fixation was applied for 6-8 weeks
16009649|NCT02815215|Procedure|Ponseti method|As a control, Patient will be treated with classical Ponseti method, including multiple steps: manipulative correction, continuous plaster, achilles tendon cutting, fixation.
16009650|NCT02815202|Drug|BAY987517|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Code: Z12-034)
16009651|NCT02815189|Procedure|Ibuprofen for post operative pain|All treatment sessions were approximately 50 minutes in length to allow for acceptable time for completion of treatment and retreatment in one or two visits. All the clinical procedures were performed by the author. Following local anesthesia with 2% lidocaine with 1:100,000 epinephrine (Septodont Saint-Maur des Fossés, France) and rubber dam isolation the tooth was disinfected with 5.25% NaOCl (Ultra bleach, Bentonville, AR, USA).
16009652|NCT02815189|Drug|Acetaminophen 325 mg for Flare up|Each patient will be evaluated a week after completion the clinical procedures.
16009653|NCT02815176|Other|Blood sampling|Sampling the blood including DNA to investigate the thrombotic profile
16009654|NCT02815163|Other|Empowerment education|"admission (1 hour)
~▪partnership
~2 ds after THR (30-45min)
~listening
~dialogue
~reflection
~action
~feedback
~2 WKs after THR (30 min)
~listening
~dialogue
~reflection
~action
~feedback
~6 WKs after THR (30 min)
~listening
~dialogue
~reflection
~action
~feedback
~10 WKs after THR (30 min)
~listening
~dialogue
~reflection
~action
~feedback"
16009655|NCT02815150|Dietary Supplement|preoperative oral carbohydrate drink|5% glucose solution 250ml 2-3 hours before surgery
16009656|NCT02815137|Other|Digital Polymerase Chain Reaction|Determination of mutation of XPO1 E571K by digital PCR in blod sample of patient with classical hodgkin lymphoma
16009657|NCT02815124|Other|Standard of Care|Post Cochlear Implant surgery, subject will receive activation/programming of their implant using Standard of Care
16009658|NCT02815124|Other|Image-Guided Cochlear Implant Programming|Post Cochlear Implant surgery, subject will receive activation/programming of their implant using Image-Guided Cochlear Implant Programming
16009659|NCT02815111|Drug|Ketamine|Receive an analgesic regimen that involves Ketamine infusions
16009660|NCT02815111|Drug|Lidocaine|Receive an analgesic regimen that involves Lidocaine infusions
16009661|NCT02815111|Drug|Acetaminophen|May be administered Acetaminophen rectally, by mouth, or intravenously in patients not suitable for either of the other methods of administration
16009662|NCT02815111|Drug|Neurontin|May be given Neurontin by mouth as an approved medication for pain control
16009663|NCT02815085|Other|RecoverLINK technology|HF patients will receive the RecoverLINK app upon study enrollment for 30-days. The Mount Sinai HF care team will interact with patients via the RecoverLINK cloud-based system during this period
16009664|NCT02815072|Other|Skin biopsy|A sample of skin (approximately 0.5cm x 0.5cm) from inner thigh area. The skin biopsy will be conducted and completed with a single stitch to close the wound under local anaesthesia to minimise any discomfort. The skin biopsy will be taken by the medical doctor trained in biopsy collection. The tissue sample will be processed and cells will be grown out of them under appropriate conditions. These cells will only be used for laboratory experiments that include experimental transplantation models and laboratory bench-top research.
16009665|NCT02815059|Drug|Ibrutinib|Ibrutinib 420mg PO daily (dose level 0) or 560mg PO daily (dose level +1) administered Day 15 through day 90.
16009666|NCT02815059|Drug|Dasatinib|Dasatinib 100mg PO daily (Day 1 through Day 90). Dasatinib dose will be increased to 140mg daily in patients tolerating dasatinib 100mg who have not achieved a complete bone marrow response (less than 5% blasts) by Day 22 or who have not achieved major molecular response by Day 43.
16009667|NCT02815059|Drug|Prednisone|Prednisone 60mg/m2 PO daily (Day 1 through Day 32)
16009668|NCT02815046|Drug|Botulinum toxin type A|Intravesical injections of Botulinum toxin A (Botox) into the bladder wall.
16009669|NCT02815046|Device|Polyacrylamide hydrogel|Midurethral injections of the bulking Agent Bulkamid into the submucosal tissues of the urethra.
16009670|NCT02815033|Drug|Enzalutamide|
16009671|NCT02815033|Procedure|11C or 18F-Choline PET/CT|
16009672|NCT02815033|Procedure|Whole body MRI|
16009673|NCT02815033|Procedure|Bone scan|
16009674|NCT02815020|Other|Boot Camp Translation - community-participatory process|Series of meetings and conference calls with expert presentation on patient self-management support, facilitated discussion, and creation of product to bring to community to improve patient self-management support
16009675|NCT02815007|Drug|Chidamide with EGFR-TKI|Chidamide and EGFR-TKI, dosage described in arm description.
16009676|NCT02814994|Behavioral|tidal volume guided by respiratory system compliance|ventilated with tidal volume guided by respiratory system compliance
16009677|NCT02814994|Behavioral|low tidal volume|ventilation ventilated with low tidal volume
16009682|NCT02814942|Device|Cardiac Resynchronization Therapy|Cardiac resynchronization therapy with or without ICD
16009683|NCT02814916|Drug|Dalbavancin single dose|Dalbavancin, weight-adjusted dose, up to 1500mg. Intravenous (IV) administration. Aztreonam may be administered at randomization for presumed co-infection with a Gram-negative pathogen and could be discontinued if a Gram-negative pathogen is not documented by culture. For suspected anaerobic pathogens, metronidazole oral/IV may be used. Patients age birth to <3 months will only receive the single-dose regimen of dalbavancin; any concomitant antibacterial therapy may be administered in this age group based on local standard of care.
16009684|NCT02814916|Drug|Dalbavancin two dose|Dalbavancin, weight-adjusted dose, up to 1000mg. Intravenous (IV) administration, with second dalbavancin weight-adjusted dose, up to 500mg. Aztreonam may be administered at randomization for presumed co-infection with a Gram-negative pathogen and could be discontinued if a Gram-negative pathogen is not documented by culture. For suspected anaerobic pathogens, metronidazole oral/IV may be used.
16009685|NCT02814916|Drug|Comparator|Course of either vancomycin not to exceed a total daily dose of 4000 mg;or oxacillin; or flucloxacillin not to exceed a total daily dose of 2000 mg. Intravenous (IV) administration. Possible oral switch after at least 72 hours from oxacillin or flucloxacillin to oral cefadroxil, or from IV vancomycin to oral clindamycin (for MRSA). Aztreonam may be administered at randomization for presumed co-infection with a Gram-negative pathogen and could be discontinued if a Gram-negative pathogen is not documented by culture. For suspected anaerobic pathogens, metronidazole oral/IV may be used. Additional comparator drugs may be used, if an alternate comparator regimen is indicated by local susceptibility patterns. No patient age birth to < 3 months will be randomized to the comparator arm.
16009686|NCT02814890|Procedure|Video-assisted Pneumonectomy|Video-assisted Pneumonectomy under general anesthesia.
16009687|NCT02814890|Procedure|Thoracic paravertebral block|The procedure is guided by ultrasound combined with nerve stimulator at T3-4, T4-5, T5-6, T6-7 of surgical side.
16009688|NCT02814877|Other|promotion of appropriate use of antibiotics in hospital|promotion of appropriate use of antibiotics in hospital by visiting physicians
16009689|NCT02814864|Drug|Mesenchymal Stromal Cell (MSC) injections|12 patients suffering of PRD (LENT-SOMA scale>2) will receive Mesenchymal Stromal Cell (MSC) injections
16009690|NCT02814851|Device|Transesophageal echocardiogram|All patients will undergo a standard surgical procedure by the surgical team of CHU Brugmann. A transesophageal echocardiogram (TEE) will be performed and the TEE probe will stay continuously during the entire procedure, to allow all necessary measurements.
16009691|NCT02814851|Device|Thermistor-tipped catheter|All patients will undergo a standard surgical procedure by the surgical team of CHU Brugmann.During the procedure, a thermistor-tipped catheter (model 93A-131-7F, Edwards, Santa Ana, CA) will be inserted into the pulmonary artery to measure right atrial pressure (Pra), pulmonary arterial pressure (Ppa), Ppao and thermodilution cardiac output. Ringer's lactate will be infused to maintain an occluded pulmonary arterial pressure (Ppao) of 8-10 mmHg.
16009692|NCT02814851|Device|Pressure/volume catheter|All patients will undergo a standard surgical procedure by the surgical team of CHU Brugmann.During the procedure, a pressure/volume catheter (CD Leicom, Zoetermeer, Netherland) will be placed in the left ventricle through a left superior pulmonary vein purse string, in order to measure alternatively LV pressure/volume loops and LA pressure.
16009693|NCT02814851|Device|Transthoracic echocardiography|"A complete transthoracic echocardiography will be performed the day before the surgical procedure. It will establish the presence of the inclusion and exclusion criteria, as stipulated above. This will be done using a Philips IE33 echocardiograph (Koninklijke Philips Electronics N.V., Netherlands).
~During the surgical procedure, a transesophageal echocardiogram will be performed, using an Acuson Sequoia system (Siemens AG, Germany)."
16009694|NCT02814838|Drug|Ladarixin|Ladarixin oral capsule
16009695|NCT02814838|Drug|Placebo|Placebo oral capsule
16009696|NCT02814825|Other|ViviGen|ViviGen Cellular Bone Matrix is a formulation of cryopreserved viable cortical cancellous bone matrix and demineralized bone. ViviGen is a Human Cells, Tissues, and Cellular and Tissue-based Product (HCT/P) as defined by the U.S. Food and Drug Administration in 21 CFR 127 1.3(d).
16009697|NCT02814812|Procedure|CT scan|
16009698|NCT02814799|Other|bone removal|
16009699|NCT02814786|Radiation|MRI scanner|"This examination is divided in 2 parts:
~Passive movement: after placing the ankle joint in the fixture, each child will be asked to relax the lower limb musculature and then the fixture will be cyclically moved by a technician at a speed which does not trigger spasticity.
~Active movement: no technician will be present and children will be asked to perform voluntary plantar-dorsiflexion between the extreme positions on the beat of the metronome."
16009700|NCT02814786|Other|Gait analysis|For gait evaluation, each child will undergo a lower limb gait analysis in a motion analysis laboratory equipped with Camera system and 4 AMTI force plates Sixteen reflective markers will be placed on the lower limbs. Each child will walk bare foot and gait will be recorded during each of five 10-meter trials. A velocity of 1 m/s (+/- 10%) will be imposed using a stop watch in order to eliminate the influence of velocity on gait kinematics and kinematics while comparing across subjects. Each child will be allowed to walk for 5 minutes after attaching the reflective markers and before recording the gait data. In addition to the joint kinematics, joint powers and moments will be computed using an inverse dynamics method.
16009701|NCT02814773|Other|questionnaires|
16009702|NCT02814760|Other|training of emergency professionals to acute stroke management|"The training program aiming at improving the timeliness of care of acute stroke patients in ED was designed for triage ED nurses and ED physicians and it was based on 3 sub-objectives:
~Improving knowledge and skills of triage nurses to recognize patients with stroke symptoms
~Improving knowledge and skills of ED physicians to recognize stroke symptoms, to realize a good quality neurological examination and be able to measure the NIHSS (National Institute of Health Stroke Score), to have a better understanding of the physiopathology of ischemic stroke and thrombolysis, and to have a better understanding of the consequences of wasted time for patients Developing, together with other hospital professionals involved in acute stroke management, a clinical pathway adapted to the local characteristics an organization (ED organization optimization, management steps, connections between ED, radiology unit and stroke unit, thrombolysis organization)."
16009703|NCT02814747|Other|quantitive study: 500 patients likely to be candidates for HTS|
16009704|NCT02814747|Other|qualitative study: 30 patients who have benefited from HTS|
16009705|NCT02814721|Device|Sonic Window ultrasound device|
16010309|NCT02810119|Drug|LO2A|
16009706|NCT02814708|Biological|rTSST-1v|Each subject of a total of seven groups will receive three injections (first injection day 0; second injection 3 months ± 4 weeks after the first, third injection 6 months ± 4 weeks after the second) of one of two different doses of Vaccine or Adjuvant, each group comprising 20 subjects. Subjects will be controlled 24 h post vaccination. Follow-up will last 18 months on the average, with visits every three months (± 2 weeks). Response to treatment is defined by seroconversion from a TSST-1 binding Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 binding Ab titer .
16009716|NCT02814669|Drug|Atezolizumab|Atezolizumab will be given at a dose of 840 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 of each 28-day cycle until loss of clinical benefit, unacceptable toxicity, or disease progression.
16009717|NCT02814669|Drug|Radium-223 Dichloride|Radium-223 dichloride will be administered at a dose of 55 kilobecquerels per kilogram (kBq/kg) via slow IV bolus on Day 1 of each 28-day cycle for up to 6 cycles.
16009718|NCT02814656|Drug|AZD8871|Multiple inhaled doses of AZD8871 will be administered via single dose dry powder inhaler (DPI). Each subject will receive a single inhaled dose of AZD8871 on Day 1 and then single once daily inhalations of AZD8871 will be administered for 12 days from Day 5 until Day 16.
16009719|NCT02814656|Drug|Placebo|Multiple inhaled doses of placebo powder will be administered via single dose DPI. Each subject will receive a single inhaled dose of placebo on Day 1 and then single once daily inhalations of placebo will be administered for 12 days from Day 5 until Day 16.
16009720|NCT02814643|Drug|Benralizumab|Benralizumab SC administered every 4 weeks for 3 doses (Weeks 0, 4, and 8).
16009721|NCT02814643|Drug|Benralizumab Placebo|Placebo administered every 4 weeks for 3 doses (Weeks 0, 4, and 8).
16009722|NCT02814643|Drug|Seasonal influenza virus vaccine|Patients will receive 1 dose of seasonal influenza virus vaccine Intramuscular (IM) at Week 8.
16009723|NCT02814630|Biological|Xolair|The patients will receive one subcutaneous injection of Xolair® (omalizumab) at a dose of 300 mg on Days 1, 30, and 60. This dose is based on the results of the international, multicenter, randomized, double-blind, placebo-controlled study which demonstrated that omalizumab significantly decreased clinical symptoms and signs of chronic idiopathic urticaria in patients who had remained symptomatic despite the use of H1-antihistamines (Maurer et al., 2013)
16009724|NCT02814617|Dietary Supplement|Cordyceps sinensis mycelium culture extract 1.68 g|Cordyceps sinensis mycelium culture extract 1.68 g
16009725|NCT02814617|Dietary Supplement|Placebo|
16009726|NCT02814604|Other|Nutrition Rating Systems|Behavioural: Nutrition Rating Systems (shown on a mobile app) provide consumers with an interpretation of the healthfulness of a food or beverage product.
16009727|NCT02814591|Device|spatially offset Raman spectrometer (SORS)|Raman spectra will be collected non-invasively from patients using a lower power 830 nm laser. A probe is brought into gentle contact with the patients skin and measurements taken. The laser power has a pre-defined safe threshold of 30 mW into a 3.5 mm diameter aperture. Built in device safety features prevent this threshold from being exceeded. The probe that comes into patient contact is suitable for disinfecting.
16009728|NCT02814578|Other|Optical coherent tomography|comparative method for BVS
16009729|NCT02814578|Other|IntraVascular UltraSound|The method of goldstandard for decision stent choice
16009730|NCT02814565|Drug|Cyclobenzaprine HCl|Cyclobenzaprine HCl extended-release capsules
16009731|NCT02814565|Drug|Placebo|Cyclobenzaprine HCl extended release placebo-matching capsules
16009732|NCT02814552|Other|HTN PRA App|The HTN PRA App will be used to adjust standard of care medication dosages for high blood pressure drugs which may include: thiazide diuretic (water pill), usually called hydrochlorothiazide (HCTZ) or chlorthalidone, and an ACE inhibitor or an angiotensin receptor blocker.
16009733|NCT02814552|Other|Blood Sample|Blood sample for plasma renin activity activity will be obtained at least once (at baseline) and if BP is not controlled after 1-3 months, an additional blood sample may be obtained.
16009734|NCT02814526|Behavioral|Aerobic exercise|Moderate/high intensity aerobic exercise will involve training at 70-80% heart rate reserve for 30 min, with an additional 10 minutes for warm-up and 5 minutes for cool-down, 4 times per week, for 12 months while supervised twice per week by a study-certified trainer at a participating YMCA .
16009735|NCT02814526|Behavioral|Stretching/balance/range of motion exercise|The stretching/balance/range of motion program will involve exercise at or below 35% heart rate reserve for 30 min, with an additional 10 minutes for warm up and 5 minutes for cool-down, 4 times per week, for 12 months while supervised twice per week by a study-certified trainer at a participating YMCA.
16009736|NCT02814513|Device|ANDAGO|Feasibility: the researchers will examine technical features as well as patient-related aspects, safety and operability of the device during static (standing) and dynamic (walking) tasks.
16009737|NCT02814513|Device|ANDAGO|Differences in static and dynamic tasks when standing/walking in the ANDAGO or when being supervised by a therapist/walking with regular walking aids.
16009738|NCT02814513|Device|ANDAGO|Investigate the handling of the ANDAGO. Patients will have time to practice with the device and the researchers will evaluate improvements in static/dynamic task performance with the ANDAGO.
16009739|NCT02814513|Device|ANDAGO|Determine which patients (characterized by demographics and neurological, cognitive and functional status) can improve their handling with the ANDAGO (i.e. whether patients can improve relatively quickly (i.e. 30 minutes of practice time) in dynamic tasks).
16009740|NCT02814513|Device|ANDAGO|To investigate how well healthy age- and gender matched children can perform the dynamic tasks (obstacle and precision course) and compare these results to those obtained in patients.
16009741|NCT02814500|Drug|DP-R212|Investigational product is prescribed to all of randomized subjects
16009742|NCT02814500|Drug|Amlodipine|Investigational product is prescribed to all of randomized subjects
16009743|NCT02814500|Drug|Rosuvastatin|Investigational product is prescribed to all of randomized subjects
16010310|NCT02810119|Drug|Placebo|
16009744|NCT02814474|Other|Na-3-hydroxybutyrate|Infusion of Na-3-hydroxybutyrate (0.18 g/kg/hour) for 390 minutes
16009745|NCT02814474|Other|Saline|Infusion of 0.9 % saline
16009746|NCT02814461|Drug|Axitinib|Axitinib (dose escalation): for total 8 weeks during and after RT, with starting dose of 1mg BID. According to the rule of traditional 3 + 3 design, 3-level axitinib dose escalation will be conducted: 1mg BID (level - I), 2mg BID (level - II) and 3mg BID (level - III).
16009747|NCT02814461|Radiation|Radiation|Radiotherapy (RT) dose (fixed strength for normal liver): 37.5 to 67.5 Gy in 15 fractions (2.5 to 4.5 Gy per fraction) to liver tumor(s) (e.g. portal vein thrombosis, tumors with size ≥3 cm, or recurrent/refractory tumors). The final prescribed dose is based on an upper limit of mean liver dose of 18 Gy for all plans. (Daily Entecavir 0.5-1mg or Telbivudine 600mg is recommended for patients with positive hepatitis B during and 3 months after RT.)
16009748|NCT02814448|Device|CryoPen|Provides a means of freezing tissue without the use of gases or liquids
16009749|NCT02814448|Device|CO2 standard cryotherapy|Standard therapy using carbon dioxide for freezing of tissue
16009750|NCT02814448|Device|Thermocoagulator|The use of heat produced by high-frequency electric current to bring about local destruction of tissues
16009751|NCT02814435|Other|Questionnaire|The participants will answer two questionnaires. These are the NEI VFQ-25 and the DLTV (daily living tasks of vision).
16009752|NCT02814435|Other|Computerised contrast sensitivity function test|This test involves the patient identifying whether bars on a screen are horizontal or vertical. It is designed to measure contrast sensitivity.
16009753|NCT02814409|Drug|Intravenous recombinant tissue plasminogen activator (rtPA) Alteplase|
16009754|NCT02814409|Drug|Intravenous Tenecteplase|
16009755|NCT02814383|Other|Brain Monitoring Platform|This study is being done to evaluate the changes in brain perfusion measured by the DCM using a comprehensive and innovative brain monitoring platform that encompasses direct and continuous measures of cerebral blood flow (CBF), cerebral oximetry, cerebral autoregulation, partial pressure of carbon dioxide (PCO2), and arterial blood pressure (ABP).
16009756|NCT02814357|Other|Control (market standard)|
16009757|NCT02814357|Other|wheat flour|
16009758|NCT02814357|Other|chickpea flour|
16009759|NCT02814357|Other|guar gum|
16009760|NCT02814357|Other|barley|
16009761|NCT02814344|Device|Electrohysterography|
16009762|NCT02814331|Device|multimodal high-resolution EEG-NIRS|
16009763|NCT02814318|Biological|Vaginal and rectovaginal swab cultures|The only intervention that will occur in this study is obtaining vaginal and recto-vaginal swab cultures upon admission to the labor and delivery room and every two hours to follow until 8 hours after administration of IV vancomycin or IV penicillin.
16009764|NCT02814305|Behavioral|Financial|Patient receives information on a program that may offer a financial benefit for disposing of unused opioid analgesics at a pharmacy
16009765|NCT02814305|Behavioral|Educational|Patient watches a video featuring narrative vignettes of patients who developed opioid dependence or abuse after using opioids postoperatively
16009766|NCT02814279|Procedure|CAF plus connective tissue graft|Periodontal surgery for root coverage by the trapezoidal flap associated with connective tissue graft.
16009767|NCT02814279|Procedure|Tunnel plus connective tissue graft|Periodontal surgery for root coverage by the tunnel flap associated with connective tissue graft.
16009768|NCT02814279|Drug|Sodium dipyrone|All participants were instructed to take 500 mg sodium dipyrone just in case of pain.
16009769|NCT02814279|Drug|chlorhexidine rinse|All participants were instructed to perform 0.12% chlorhexidine rinse after the surgical procedures.
16009770|NCT02814266|Other|difficult intubation|Goniomastoid Distance: The distance between gonion and mastoid while the neck is fully extension and the mouth maximally open. Thyrogonial Distance: The distance between thyroidea and gonion while the neck is fully extension and the mouth maximally open.
16009771|NCT02814266|Other|easy intubation|Goniomastoid Distance: The distance between gonion and mastoid while the neck is fully extension and the mouth maximally open. Thyrogonial Distance: The distance between thyroidea and gonion while the neck is fully extension and the mouth maximally open.
16009772|NCT02814240|Other|NMR|
16009773|NCT02814240|Biological|Blood samples|
16009774|NCT02814240|Other|fibroscan|
16009775|NCT02814227|Device|Zansors® sleep screening device|Intervention is the validation of a sleep apnea screening device against the gold-standard assessment of in-laboratory polysomnography
16009776|NCT02814214|Device|ECG+IEGM|Cardiac Resynchronization Therapy programming adjustments
16009777|NCT02814201|Behavioral|SRT|"simple reaction time ( SRT) defined as the fastest response time to a target stimulus ( phase worst -off at the Parkinson's patient )"
16009778|NCT02814188|Other|Carbohydrate Beverage|750 ml of a 13.5% carbohydrate (sucrose) beverage
16009779|NCT02814188|Other|Placebo Beverage|750 ml of an artificially-sweetened beverage
16009780|NCT02814175|Drug|methotrexate (MTX)|
16009781|NCT02814175|Biological|adalimumab (ADA)|
16009782|NCT02814149|Procedure|Type 1 implant placement|Implant is placed immediately following tooth extraction in one surgical procedure
16009783|NCT02814149|Procedure|Type 3 implant placement|Implant is placed in the site which is left to heal for 3 months following tooth extraction
16009784|NCT02814136|Procedure|Ablation|
16009785|NCT02814123|Other|24-hour inpatient intervention|Subjects will be admitted at the research facility at 7:30. A cannula will be inserted into an arm or a hand vein for blood sampling purposes. Each 24-hour intervention visit includes 3 standardized meals (8:00, 12:00, and 17:00), an evening snack (21:00) and an overnight stay. The glucose level as measured by the real time sensor will be entered manually into the computer every 10 minutes. The insulin and pramlintide pumps' infusion rates will then be changed manually based on the computer generated recommendation, while still maintaining the ratio. The computer generated recommendations are based on a predictive algorithm.
16009786|NCT02814110|Drug|Granulocyte colony-stimulating factor (Filgrastim)|Drug administration
16009787|NCT02814097|Drug|elamipretide|Subcutaneous injection of 40 mg elamipretide once daily for 28 consecutive days
16009788|NCT02814097|Drug|Placebo|Subcutaneous injection of placebo administered once daily for 28 consecutive days
16009789|NCT02814084|Device|Bilateral Internal Mammary Artery grafts|Sternal Wound Edge Oxygenation in patients undergoing Coronary Artery bypass surgery with Bilateral Internal Mammary Artery grafts
16009790|NCT02814084|Device|Prevena|The Prevena wound management system applies negative pressure to the closed wound for up to 7 days and is associated with lower rates of surgical site infection.
16009791|NCT02814071|Other|Early enteral feeding|Early enteral feeding as per description
16009792|NCT02814058|Drug|zolpidem hemitartarate 1.75 mg - Sequency 1|zolpidem hemitartarate 1.75 mg in fasting (period 1) and zolpidem hemitartarate 1.75 mg postprandial (period 2)
16009793|NCT02814058|Drug|zolpidem hemitartarate 1.75 mg - Sequency 2|zolpidem hemitartarate 1.75 mg postprandial (period 1) and zolpidem hemitartarate 1.75 mg in fasting (period 2)
16009794|NCT02814019|Drug|Idebenone 150 mg film-coated tablets|
16009795|NCT02814019|Drug|placebo|
16009796|NCT02814006|Other|health educational video|visualization of health educational video
16009797|NCT02813993|Other|Health educational video|
16009798|NCT02813980|Other|There are no interventions. This is a prospective observational study.|
16009799|NCT02813967|Radiation|Radiotherapy 54 Gy|Radiotherapy was administered in 1.8 Gy fractions 5 times weekly to a total dose of 54 Gy.
16009800|NCT02813967|Radiation|Radiotherapy 60 Gy|Radiotherapy was administered in 2 Gy fractions 5 times weekly to a total dose of 60Gy.
16009801|NCT02813967|Drug|S-1|S-1 70mg/m2 was administered on days 1-14 and 29-42.
16009802|NCT02813954|Device|Blood Gas Sampling|analyzing amniotic fluid by blood gas device
16009803|NCT02813941|Other|Current GRADE SoF table|The current GRADE SoF table will be the common comparator for the other two SoF tables
16009804|NCT02813941|Other|Alternative GRADE SoF table|The alternative GRADE SoF table format will be developed from a user-testing survey.
16009805|NCT02813941|Other|EPC SoF table|For the EPC SoF table, the investigators will use one of their format which was recently published
16009806|NCT02813928|Genetic|ccfDNA analysis|The level of circulating ccfDNA, defined as extra cellular DNA, increases in CRC patients. The Inplex® method could validate the use of ccfDNA as a cancer biomarker in terms of prognosis and surveillance
16009807|NCT02813915|Device|NICOM|Use of NICOM and PLR to obtain patient fluid status
16009808|NCT02813902|Drug|Heliocare with Fernblock PLE technology|240 mg taken orally daily over the course of 1 year
16009809|NCT02813902|Other|Sugar Pill|A pill that appears similar to the supplement
16009811|NCT02813876|Other|Enhanced recovery protocol|
16009812|NCT02813863|Drug|SP2086|
16009813|NCT02813863|Drug|Metformin|
16009814|NCT02813850|Device|oxygen therapy|Oxygen therapy early in the night (2L/min) during 4hours per days
16009815|NCT02813837|Biological|CD19CART|Patients will be given infusions of CD19CART cells into the vein over a period of 1 to 3 days. The target dose range administered in this study is 1x10e5-1x10e7 CD19CART cells/kg. Patients will be monitored for a response, toxic effects, and the expansion and persistence of circulating CD19CART cells.
16009816|NCT02813824|Drug|Acetylsalicylic acid lysinate 300 mg|Daily dose during 4 years
16009817|NCT02813824|Drug|Placebo (for Aspirin 300)|Daily dose during 4 years
16009818|NCT02813824|Drug|Acetylsalicylic acid lysinate 100 mg|Daily dose during 4 years
16009819|NCT02813824|Drug|Placebo 100 (for Aspirin 100)|Daily dose during 4 years
16009820|NCT02813798|Drug|Rivipansel|A single 840mg dose of Rivipansel over 20 minutes
16009823|NCT02813772|Dietary Supplement|Milk formula NAN Sensitive, Nestle|Infants randomized to group 1 will receive the milk formula NAN Sensitive, Nestle for a period of 4 weeks.
16009824|NCT02813772|Dietary Supplement|Milk formula Optipro, Nestle|Infants randomized to group 1 will receive the milk formula NAN Optipro, Nestle for a period of 4 weeks.
16009825|NCT02813759|Other|Sucralose|Subjects drank 200 mL of water with 14 mg sucralose, followed by a standard breakfast.
16009826|NCT02813759|Other|Placebo|Subjects drank 200 mL of water alone (placebo), followed by a standard breakfast.
16009827|NCT02813746|Dietary Supplement|Fitness program|
16009828|NCT02813746|Behavioral|Stop smoking|
16009829|NCT02813746|Procedure|Endometrial fluid collection|
16009830|NCT02813733|Procedure|Thyroid surgery|Thyroidectomies performed by all surgeons in 5 academic hospitals in France.
16009831|NCT02813720|Radiation|HR-pQCT High resolution peripheral quantitative CT-scan|"HR-pQCT is a powerful device providing low dose irradiation already used in bone field.
~It is a high resolution tool (voxel size=82µm) that the investigators adapted to look after the distal joint involved by onycholysis. An anteroposterior scout view is used to define the region of interest (ROI), which spanned from the top of the distal phalange to the distal part of the intermediate phalange in order to contain the distal joint of the target finger. Images are then analysed for erosions, osteophytes and volumetric bone mineral density."
16009832|NCT02813707|Other|QoL questionnaire regarding the long term complication|Micronutrients evaluation
16009833|NCT02813694|Drug|lefamulin|antibacterial agent
16009834|NCT02813694|Drug|Moxifloxacin|antibacterial agent
16009835|NCT02813681|Procedure|US-epidural SVD|participants who received US examination prior to epidural placement. The purpose of this group is to determine if US derived landmarks reduce pressure sensitivity.
16009836|NCT02813681|Procedure|US sham- epidural SVD|participants who received US examination process but with the monitor turned off. The purpose of this group is to determine if the standard of care epidural placement technique will increase pressure sensitivity at the insertion site. The purpose of this group will also be to reduce the placebo effect from the US exam and to maintain blinding of the patient to their group status (US epidural or US sham epidural).
16009837|NCT02813681|Procedure|Spontaneous vaginal delivery without an Epidural|Spontaneous vaginal delivery without an Epidural The purpose of the control group is to serve as a baseline (or a measure of normal). The control participant's measurement will be compared to those that did receive treatments (either epidural alone or ultrasound and epidural). This information will tell the investigator how many women have back pain after spontaneous vaginal delivery. Participant must meet the inclusion requirements and not meet any of the exclusion requirements
16009838|NCT02813668|Behavioral|Lifestyle Intervention Training Program|Participants will be placed into a peer-led classes of 10 to 12 people. The curriculum contains sixteen core sessions that occur weekly for four months followed by an eight month maintenance period. During lifestyle classes, participants will learn strategies for eating a healthy diet, increasing physical activity, overcoming barriers, building social support, reaching and maintaining a healthy wait, and maintaining healthy blood glucose levels. Participants will also be assigned goals to achieve; increasing physical activity and losing 5% of their baseline body weight. During maintenance, participants will receive biweekly SMS text messages providing lifestyle advice tips and encouragement.
16009841|NCT02813642|Biological|Plasma osteoprotegerin level|dosage of plasma osteoprotegerin
16009842|NCT02813642|Biological|Plasma fibroblast growth factor 23 level|dosage of plasma fibroblast growth factor 23
16009843|NCT02813642|Procedure|Vascular calcification score|measurement of vascular calcification score by X-ray of the lateral abdominal aorta
16009844|NCT02813629|Device|tDCS plus PES|"transcranial direct current stimulation (tDCS) uses a pair of electrodes and sponges soaked in saline solution placed over specific regions of the head to polarize neurons and produce changes in resting membrane potentials. This changes may increase or decrease neuronal excitability and produce diverse clinical effects, including analgesia.
~PES uses also a pair of electrodes over specific regions of the body to promote neuronal action potentials in peripheral nerves. PES over motor threshold increases cortical excitability, and at the sensory threshold decreases excitability."
16009845|NCT02813603|Procedure|EBUS|19G and 22G EBUS needles are compared in a randomized prospective way in lung cancer patients with enlarged mediastinal lymph nodes.
16009846|NCT02813590|Other|Ascitic fluid puncture|
16009847|NCT02813590|Other|Skin swaps from puncture side|
16009848|NCT02813590|Other|Stool samples|
16009849|NCT02813577|Device|Lutonix® 035 Drug Coated Balloon PTA Catheter|Female subjects will receive the Lutonix® 035 Drug Coated Balloon PTA Catheter.
16009850|NCT02813564|Behavioral|Cognitive Assessment & Video-game INtervention Solutions (CAVINS)|"This is a computerized video-game like intervention. The participants will exercise/strengthen the cognitive (mental) deficits that may be responsible for symptom profiles such as socialization impairments, academic disabilities, and repetitive behaviour for several weeks. This program will stimulate communication between brain regions that make up an information processing neural network in order to promote proper network development."
16009851|NCT02813551|Drug|Torsemide|
16009852|NCT02813551|Drug|Placebo|
16009853|NCT02813538|Drug|Indocyanine green clearance|To evaluate liver function by injection of indocyanine green by a peripheral vein and measure its clearance
16009854|NCT02813538|Other|Thromboelastometry|To evaluate blood coagulation impairment by obtaining blood sample from a peripheral vein and measure anticoagulant proteins levels plus obtaining thromboelastometry
16009855|NCT02813525|Other|ISI index on Doppler systolic flow in the aortic isthmus|Measure of the ISI index on Doppler systolic flow in the aortic isthmus in the follow-up by ultrasound of the fetus
16009856|NCT02813512|Drug|ADSCs|Autologous ADSCs
16009857|NCT02813499|Other|CARE Rule|Evaluation of the clinical suspicion of myocardial infarction, calculation of CARE rule and troponin assay performed by the practitioner.
16009858|NCT02813486|Biological|Biological: GC3111 vaccine|0.5mL, Intramuscular
16009859|NCT02813486|Biological|Biological: Boostrix® vaccine|0.5mL, Intramuscular
16009860|NCT02813473|Radiation|Coronary Angiography|Coronary angiography is an X-ray test to diagnose diseases of the arteries that supply blood to the heart. Coronary angiography can detect weakened blood vessel walls and narrowed or blocked vessels. X-rays are taken after a special dye has been injected into the bloodstream, making the vessels and blood flow through the vessels visible on X-rays.
16009861|NCT02813473|Radiation|Computed Tomography (CT) scan|A CT scan is an X-ray imaging technique that uses a computer to produce cross-sectional images. It can be used to examine the heart and blood vessels for problems
16009862|NCT02813460|Drug|Formulation A (ALS-008176)|Reference formulation, 60 mg/mL ALS-008176 oral suspension without sweetener/flavor.
16009863|NCT02813460|Drug|Formulation B (ALS-008176)|60 mg/mL ALS-008176 oral suspension containing 12 mg/mL sucralose.
16009864|NCT02813460|Drug|Formulation C (ALS-008176)|60 mg/mL ALS-008176 oral suspension containing 4 mg/mL sucralose and strawberry flavor.
16009865|NCT02813460|Drug|Formulation D (ALS-008176)|60 mg/mL ALS-008176 oral suspension containing 4 mg/mL sucralose and masking flavor and strawberry flavor.
16009866|NCT02813460|Drug|Formulation E (ALS-008176)|60 mg/mL ALS-008176 oral suspension containing 4 mg/mL sucralose and masking flavor and cream vanille flavor.
16009867|NCT02813460|Drug|Formulation F (ALS-008176)|60 mg/mL ALS-008176 oral suspension containing 4 mg/mL sucralose and fantasy fruit flavor.
16009868|NCT02813460|Drug|Formulation G1 (ALS-008176)|60 mg/mL ALS-008176 oral suspension with concentration 1 of sucralose (maximum 12 mg/mL) and best flavor 1 from session 1.
16009869|NCT02813460|Drug|Formulation G2 (ALS-008176)|60 mg/mL ALS-008176 oral suspension with concentration 2 of sucralose (maximum 12 mg/mL) and best flavor 1 from session 1.
16009870|NCT02813460|Drug|Formulation G3 (ALS-008176)|60 mg/mL ALS-008176 oral suspension with concentration 3 of sucralose (maximum 12 mg/mL) and best flavor 1 from session 1.
16009871|NCT02813460|Drug|Formulation H1 (ALS-008176)|60 mg/mL ALS-008176 oral suspension with concentration 1 of sucralose (maximum 12 mg/mL) and best flavor 2 from session 1.
16009872|NCT02813460|Drug|Formulation H2 (ALS-008176)|60 mg/mL ALS-008176 oral suspension with concentration 2 of sucralose (maximum 12 mg/mL) and best flavor 2 from session 1.
16009873|NCT02813460|Drug|Formulation H3 (ALS-008176)|60 mg/mL ALS-008176 oral suspension with concentration 3 of sucralose (maximum 12 mg/mL) and best flavor 2 from session 1.
16009874|NCT02813447|Drug|Sertraline|
16009875|NCT02813447|Drug|Placebo|
16009876|NCT02813434|Biological|florbetapir|18F-AV-45 or 18F-Florbetapir
16009877|NCT02813421|Device|CGM Informed|
16009878|NCT02813395|Device|Low Level Laser Therapy|"Low Level Laser Therapy was applied at four points to the dominant upper limb of the volunteers on the muscle belly of the biceps. Delineation was done using a measuring tape from the elbow joint line to the acromion marked at points corresponding to 20%, 30%, 40% and 50% of this distance, focusing the application on the muscle belly region, thereby excluding the tendinous region.
~An 808 nm equipment was used for applying laser therapy, with a power of 100 mW and total energy of 20 J."
16009879|NCT02813395|Device|Placebo Laser|Laser application simulation with a second pen of the laser device, which was disconnected and did not effectively irradiate energy.
16009880|NCT02813382|Drug|Bupivacaine|Spinal anesthesia was performed using 10.5mg bupivacaine with added sufentanil (2µg).
16009881|NCT02813382|Drug|Prilocaine|Spinal anesthesia was performed using 60mg prilocaïne with added sufentanil (2µg).
16009882|NCT02813382|Drug|Chloroprocaine|Spinal anesthesia was performed using 40mg hyperbaric 2-chloroprocaïne with added sufentanil (2µg).
16009883|NCT02813369|Drug|naloxegol|non-interventional study where patients are exposed to naloxegol during normal clinical practice
16009884|NCT02813369|Drug|non-PAMORA laxative|non-interventional study where patients are exposed to non-peripherally acting mu-opioid receptor antagonist (PAMORA) laxative
16009885|NCT02813356|Drug|naloxegol|non-interventional study where naloxegol is prescribed during normal clinical practice
16009886|NCT02813356|Drug|non-PAMORA|non-interventional study where patients are exposed to non-peripherally acting mu-opioid antagonists during the normal course of clinical practice
16009887|NCT02813343|Device|BlueStar app|BlueStar is a smart-phone enabled application that is designed to serve as a virtual coach for patients. The app sends daily evidence-based, real-time messages as well as longitudinal feedback on how to improve diabetes management. The Bluestar app has been shown to be effective at teaching patients about dietary impacts on their blood glucose levels, encouraging patients to generate higher-quality blood glucose data for enhanced self-monitoring, and to improve overall management of diabetes as represented by reductions in levels of HgbA1c. Benefits have been demonstrated in time periods as brief as three months. One US based study showed a decrease in hospitalizations and emergency department visits among participants who use the application.
16009888|NCT02813330|Other|Subcutaneous sterile water injection|sterile water injection in two points of low back pain
16009889|NCT02813330|Other|saline injection|Saline injection in two points of low back pain
16009890|NCT02813304|Behavioral|Gradual reloading|Participants will be asked to perform isometric strengthening exercises in lateral rotation and abduction. Participants will place their affected arm by the side with the elbow gently tucked in close to the body, elbow flexed at 90°, and the thumb pointing upwards. The opposite hand will resist the lateral rotation and abduction. They will be asked to push against the uninvolved hand, building up to sub-maximal pressure (approximately 50% to 75% of the maximum possible force) over five seconds. Then the contraction will be slowly released. A maximum pain level of 5/10 will be accepted when performing the contraction. Elevation movements will also be performed 3 times a day in the frontal, sagittal and scapular plane.
16009891|NCT02813304|Behavioral|Rest and cryotherapy|Participants will be asked to apply ice wrap on their painful shoulder 3 times a day over the area of pain for 15 minutes. They will be asked to place the ice wrap inside a damp towel cloth (minimise the risk of an ice burn) and secure around the shoulder with a towel. After the 15 minutes, they will be asked to perform gentle, slow, pain free shoulder movements that do not provoke pain. All participants will be provided with a commercial ice wrap. They will also be asked to avoid painful movements, working above shoulder level, repeated or sustained elevation movements and lifting weights.
16009892|NCT02813291|Device|tDCS|"All subjects will mentally repeat a complex finger sequence with the left hand, for 13 min:
~- Subjects of the Stimulation groups (Young Stim and Elderly Stim) will receive in parallel an anodal tDCS of the primary motor cortex."
16009893|NCT02813291|Device|sham tDCS|"All subjects will mentally repeat a complex finger sequence with the left hand, for 13 min:
~- Subjects of the Sham groups (Young Sham and Elderly Sham) will receive in parallel a sham tDCS of the primary motor cortex."
16009894|NCT02813278|Dietary Supplement|simo decoction|Participants allocated to SMD and acupuncture were asked to take oral SMD decoction (Hansen Co., Ltd., Yiyang, Hunan province, China, 10 mL/dose) three times per day beginning on the first day after colorectal resection. They also received bilateral injections of vitamin B1 (50 mg x 2) at the tsusanli acupoint one time per day. This intervention was performed for a total of 5 consecutive days or until flatus.
16009895|NCT02813278|Other|gum chewing|Participants allocated to chewing gum were instructed to chew commercially available sugar-free gum (Extra & Reg, Wm. Wrigley Jr. Co., Ltd., Shanghai, China) three times daily starting on the first postoperative morning. They were instructed to chew the piece of gum for at least 10 min. This intervention was performed for 5 consecutive days or until flatus.
16009896|NCT02813265|Drug|KPI-121 0.25% Ophthalmic Suspension|
16009897|NCT02813265|Drug|Vehicle of KPI-121 0.25% Ophthalmic Suspension|
16009898|NCT02813252|Genetic|JCAR015|No study drug is administered in this study. Patients who received JCAR015 in a previous trial will be evaluated in this trial for long-term safety and efficacy.
16009899|NCT02813239|Other|hCG|Oocyte maturation with hCG
16071163|NCT02374567|Drug|Agomelatine|
16009900|NCT02813239|Other|hCG + GnRH agonist|Oocyte maturation with hCG + GnRH agonist
16009901|NCT02813226|Other|Molecular Imaging|Baseline and follow-up FDG PET-CT and DCFPyL PET-CT
16009902|NCT02813213|Procedure|Skin micro Grafts|0.8 x 0.8 skin micro graft with graft to graft distance of 4 cm (1:50 expansion) bathed with keratinocyte growth factor solution ( 1.5 ml for each 14 square centimeters of wound)
16009903|NCT02813213|Procedure|Standard skin graft|Standard split thickness (0.3-0.5mm) skin graft
16009904|NCT02813200|Drug|Seretide® Diskus® 500/550 μg|Every day during 7 days
16009905|NCT02813200|Drug|Ultibro® Breezhaler® 110/50 μg|Every day during 7 days
16009906|NCT02813200|Drug|Spiriva® Respimat® 2,5 μg|Every day during 7 days
16009907|NCT02813187|Biological|cellular and tissue based therapy|
16009908|NCT02813187|Procedure|debridement|
16009909|NCT02813187|Procedure|advanced wound therapy|
16009910|NCT02813187|Dietary Supplement|Nutritional screening|
16009911|NCT02813174|Behavioral|Compassionate Mind Training from Compassion-Focused Therapy|
16009912|NCT02813161|Biological|cellular and tissue based therapy|
16009913|NCT02813161|Device|negative pressure wound therapy|
16009914|NCT02813161|Procedure|debridement|
16009915|NCT02813161|Procedure|advanced wound therapy|
16009916|NCT02813161|Dietary Supplement|Nutritional screening|
16009917|NCT02813161|Device|off-loading|
16009918|NCT02813161|Device|Hyperbaric oxygen Therapy|
16009919|NCT02813148|Drug|Naloxegol|Non-interventional study of drug utilization
16009920|NCT02813135|Drug|Ribociclib|
16009921|NCT02813135|Drug|Topotecan|
16009922|NCT02813135|Drug|Temozolomide|
16009923|NCT02813135|Drug|AZD1775|
16009924|NCT02813135|Drug|Carboplatin|
16009925|NCT02813135|Drug|Olaparib|
16009926|NCT02813135|Drug|Irinotecan|
16009927|NCT02813135|Drug|Nivolumab|
16009928|NCT02813135|Drug|Enasidenib|
16009929|NCT02813135|Drug|Lirilumab|
16009930|NCT02813122|Device|x-ray|x-ray for the detection of leaks and bleeding
16009931|NCT02813096|Drug|folfox4 chemotherapy regimen|"Folfox regimen:Oxaliplatin 85 mg/m2 in 250 mL 5% glucose solution, IVD (administered as 2-hour infusion) on day 1;leucovorin 200 mg/m2 in 100 mL 0.9% NaCl solution, IVD (administered as 2-hour infusion) on days 1 and 2; 400 mg/m2 5-FU in 20mL 0.9% NaCl solution, IV(administered as follow leucovorin); then 600 mg/m2 5-FU in 100 mL 0.9% NaCl solution (administered as 22-hour continuous infusion) on days 1 and 2 of each 14 days cycle.
~Number of cycles: 4 cycles, or until progression or unacceptable toxicity develops."
16009932|NCT02813096|Other|Placebo|"Placebo regimen:250 mL 5% glucose solution, IVD (administered as 2-hour infusion) on day 1; 100 mL 0.9% NaCl solution, IVD (administered as 2-hour infusion) on days 1 and 2; 20mL 0.9% NaCl solution, IV; then 100 mL 0.9% NaCl solution (administered as 22-hour continuous infusion) on days 1 and 2 of each 14 days cycle.
~Number of cycles: 4 cycles, or until progression or unacceptable toxicity develops."
16009933|NCT02813083|Other|No intervention (observational)|No intervention (observational)
16009934|NCT02813070|Drug|[18F] Flutemetamol|PET brain imaging and Magnetic resonance brain imaging
16009935|NCT02813057|Procedure|Stoppa inguinal hernia repair|Stoppa inguinal hernia repair
16009936|NCT02813057|Procedure|Total extraperitoneal inguinal hernia repair|Total extraperitoneal inguinal hernia repair
16009937|NCT02813044|Drug|total intravenous anesthesia (TIVA)|In the TIVA group,anesthesia is induced and maintained by effect-site target controlled infusion of propofol and remifentanil.
16009938|NCT02813044|Drug|inhalation anesthesia group|In the inhalation anesthesia group, anesthesia is induced by pentothal sodium 4-6mg/kg and remifentanil 1 μg/kg, and then maintained with end-tidal sevoflurane concentration of 0.8 to 1 MAC and continuous infusion of remifentanil at 0.1-0.3μg/kg/min.
16009939|NCT02813031|Other|Functional meat products|
16009940|NCT02813031|Other|Traditional meat products|
16009941|NCT02813018|Procedure|0.2 ml/kg of 0.2% ropivacaine|In the preemptive group, 5 minutes before skin incision, the epidural catheter is dosed with 0.2 ml/kg of 0.2% ropivacaine, followed by continuous infusion of 5 minutes before skin incision at 0.2 ml/kg/h.
16009942|NCT02813018|Procedure|0.2mg/kg of Normal Saline|In the saline group, 5 minutes before skin incision, the epidural catheter is dosed with 0.2 ml/kg of normal saline, followed by continuous infusion of 5 minutes before skin incision at 0.2 ml/kg/h.
16009943|NCT02813005|Procedure|Jet ventilation group|MONSOON III™ (Acutronic Medical System AG®, SEBAC) with Double lumen catheter 12CH (Acutronic Medical System AG®, SEBAC)
16009944|NCT02813005|Procedure|Standard ventilation group|apnea made by the anesthesiologist to the request of the radiologist
16009945|NCT02812992|Drug|Nab-paclitaxel|
16009946|NCT02812992|Drug|Gemcitabine|
16009947|NCT02812992|Other|Best Supportive Care|
16009948|NCT02812979|Device|Airvo2 with Aerogen Solo|Nebulization of salbutamol with Airvo 2 and Aerogen solo
16009949|NCT02812979|Device|Mask|Usual nebulization of salbutamol with mask
16009950|NCT02812979|Device|arm control Airvo2 without nebulization of salbutamol|Airvo2 with Aerogen Solo. No nebulization of salbutamol
16009951|NCT02812966|Device|Lutonix|Drug Coated Balloons
16009952|NCT02812966|Device|IN.PACT|Drug Coated Balloons
16009953|NCT02812940|Drug|Everolimus|GvHD prophylaxis
16009954|NCT02812927|Device|Edelvaiss Multiline-8|Optimised infusion line
16009955|NCT02812927|Device|Standard infusion line|
16009956|NCT02812914|Other|Low-cost gas stove|Women will be provided with a 3-burner liquid propane gas stove and one year's supply of gas
16009957|NCT02812914|Behavioral|Peer education classes|Women will participate in four classes on how to safely use gas stoves and methods to reduce exposure to air pollution
16009958|NCT02812914|Behavioral|Resource-intensive behavioral intervention approach|Women will participate in four classes on how to safely use gas stoves and methods to reduce exposure to air pollution. Additionally, peer educators will visit each home after group classes to help the woman, and key decision-makers in her family, identify top priority strategies to reduce air pollution. Using a checklist, peer educators will observe whether household members are adhering to tailored strategies at subsequent home visits, and provide ongoing support to women and their families.
16010597|NCT02808000|Device|Standard catheter|
16009959|NCT02812901|Procedure|cardiac surgery scheduled in the morning|cardiac surgery scheduled in the morning
16009960|NCT02812901|Procedure|cardiac surgery scheduled in the afternoon|cardiac surgery scheduled in the afternoon
16009961|NCT02812888|Drug|thionamide treatment for 3 months|Hyperthyroid patients would received thionamide treatment (methimazole, propylthiouracil, or propranolol) for 3 months, and euthyroidism would be obtained.
16009962|NCT02812875|Drug|CA-170|"Dose escalation stage (Phase 1a) accelerated titration and standard 3+3 dose escalation in patients with advanced solid tumor or lymphoma.
~Dose expansion stage (Phase 1b) in patients with tumors that are shown to be responsive to anti-PD-1 or anti-PD-L1 checkpoint inhibitors and/or in tumor types known to express PD-L1 or VISTA, including but not limited to: mesothelioma, melanoma, non-small cell lung cancer, renal cell carcinoma, Hodgkin lymphoma, triple negative breast cancer, head and neck cancer, colorectal cancer, gastric cancer, bladder cancer, and ovarian cancer."
16009963|NCT02812862|Drug|Ultibro/ Breezhaler|LABA/ LAMA combination therapy a combination of two bronchodilators acting on two separate pharmacological targets - one ß-agonist and one anti-muscarinergic agent
16009964|NCT02812849|Drug|Cu-64 DOTATATE|
16009965|NCT02812836|Device|Manometry|Each patient will be investigated first by anorectal manometry, standard protocol of conventional parameters will be recorded such as: resting pressure, squeeze pressure, bear down manoeuver, thresholds of sensation and threshold of recto anal inhibitory reflex. 3D picture of anal canal will be recorded. After that balloon with 50 ml of water will be inserted into the rectum and patient will be asked to expel the device within 1 min in privacy.
16009966|NCT02812823|Device|High-resolution anorectal manometry|Recording of conventional manometric parameters after insertion of the catheters.
16009967|NCT02812810|Device|active rTMS|
16009968|NCT02812810|Device|sham rTMS|
16009969|NCT02812784|Device|Nephrocheck TM|
16009970|NCT02812771|Drug|Efinaconazole|Solution
16009971|NCT02812758|Device|transthoracic echocardiography|recording of data on cardiac output measured non-invasively by transthoracic echocardiography, including the SVV
16009972|NCT02812745|Device|recording of cardiac output|
16009973|NCT02812745|Device|other parameters|BIS (bispectral index ), PI (perfusion index ), etCO2 (end-tidal carbon dioxide ), and brain NIRS (near-infrared spectroscopy)
16009974|NCT02812732|Behavioral|DOSE HPV|"The primary goals of the DOSE HPV intervention are to 1) change clinician HPV vaccine recommendations and responses to hesitant parents, and 2) support systems changes to improve the vaccination process. The first four sessions follow a standardized curriculum, while the last three sessions include development and implementation of tailored activities designed to meet individual practice needs.
~Sessions 1 and 2 generate motivation for the project through feedback of vaccination rates (Session 1) and education on HPV disease (Session 2). Brief Negotiated Interview (BNI) skills are taught in Sessions 3&4. Action Plans are developed in Session 5. Sessions 6&7, which follow a standard quality improvement format: plan-do-study-act (PDSA) cycles."
16009975|NCT02812719|Drug|Glycolic acid peel alone|"One of two sides of the face will be randomly treated with glycolic acid peel 35% alone.
~This treatment will be administered at visit 1 (but to entire face) and 3 subsequent visits (to one randomly selected side of the face), for a total of 4 treatments at 2 week intervals"
16009976|NCT02812719|Drug|Glycolic and salicylic acid peel|"The other randomly chosen side of the face will be treated with glycolic acid peel 35% followed by salicylic acid peel 20%, as a combination treatment.
~This treatment will be administered at visits 2, 3 and 4 (to one randomly selected side of the face), for a total of 3 treatments at 2 week intervals."
16009977|NCT02812706|Drug|Isatuximab SAR650984|Pharmaceutical form:solution Route of administration: intravenous
16009978|NCT02812693|Drug|Imatinib Mesylate|Given PO
16009979|NCT02812693|Other|Laboratory Biomarker Analysis|Correlative studies
16009980|NCT02812693|Biological|Pembrolizumab|Given IV
16009981|NCT02812680|Other|Blood Draw|Blood draw to assess the use of circulating microRNA (miRNA) and circulating tumour cells (CTC) as biomarkers of cancer and predictive markers for neoadjuvant therapy.
16009982|NCT02812667|Drug|Nivolumab + Plinabulin|
16009983|NCT02812654|Drug|Doxorubicin|Doxorubicin 75mg/m2 (cycle 1,2 and 3)
16009984|NCT02812654|Drug|Ifosfamide|Ifosfamide 9 g/m2 (cycle 1 and 3)
16009985|NCT02812654|Radiation|radiotherapy|radiotherapy: 25 Gy / 5 x 500 cGy/day
16009986|NCT02812641|Drug|BPF-CCRT (run-in)|Six patients will be enrolled in run-in phase. If <= 1 patient developed dose-limiting toxicity, the trial will be continued to randomized phase. If > 1 patients developed dose-limiting toxicities, the protocol will be discontinued.
16009987|NCT02812641|Drug|BPF-CCRT (randomized)|Twenty-two patients will be planned to assign to the experimental arm
16009988|NCT02812641|Drug|PF-CCRT (randomized)|Twenty-two patients will be planned to assign to the active control arm
16009989|NCT02812628|Procedure|LAPR|Patients undergoing conventional LAPR, the common surgical procedure to treat low rectal cancer ≤5m from anal verge.
16009990|NCT02812628|Procedure|LAPR-TILT|Patients undergoing LAPR-TILT, a modified APR procedure that is supposed to be safer and less invasive as compared to the LAPR.
16009991|NCT02812615|Dietary Supplement|Egg|After enrollment, participants will receive one large egg 6 days a week for 3, 2 and 2 months for stunted children, children at risk of stunting, and malnourished adults, respectively.
16009992|NCT02812615|Dietary Supplement|Milk|After enrollment, participants will receive 150ml of milk 6 days a week for 3, 2 and 2 months for stunted children, children at risk of stunting, and malnourished adults, respectively.
16009993|NCT02812615|Drug|Albendazole/Pyrantel Pamoate|As per the national guidelines, treatment will be provided based with 200 mg of Albendazole or 10mg/kg Pyrantel Pamoate single dose if the participants have not been treated for helminths in the preceding three months.
16009994|NCT02812615|Behavioral|Nutritional counselling|Parents/caregivers will be given nutritional counselling
16009995|NCT02812615|Dietary Supplement|Micronutrient sprinkles|For the child cohort, one sachet of multiple micro-nutrient sprinkles per day to be administered with the mid-day meal for two months
16009996|NCT02812602|Drug|Lidocaine patch|Lidocain patch will be applied around the surgical wound about 20 minutes before removal of staples.
16009997|NCT02812602|Drug|placebo|Placebo patch will be applied around the surgical wound about 20 minutes before removal of staples.
16009998|NCT02812589|Other|Diffusion tensor imaging (DTI) in Breast MRI|
16009999|NCT02812563|Other|genetic|Galilee exam - Corn analysis with Optiwave Refractive Analysis
16010000|NCT02812550|Procedure|colonoscopy procedure|endoscopy performed with a standard forward view colonoscopy or with full-spectrum endoscopy
16010001|NCT02812537|Other|patients with conduct disorders|interview with a specialist
16010002|NCT02812524|Drug|Intratumoral Ipilimumab|Patients with a planned resection of SCCHN will have a biopsy procedure 7-10 days prior to surgery and receive an injection of ipilimumab directly into a tumor.
16010003|NCT02812511|Procedure|Biopsy|Skin biopsy is performed at the arm with a punch of 3 mm in diameter or a scalpel under local anesthesia, and then preserved in low glucose DMEM at room temperature.
16010004|NCT02812498|Other|Teleconsultation|The patients in the consultation group arranged their bookings on a website, where they could also access to web educational courses or to nutritional and psychological counselling
16010005|NCT02812498|Other|Standard|Group of patients followed in a traditional way
16010006|NCT02812472|Other|Treadmill training with functional electrical stimulation|
16010007|NCT02812472|Other|Treadmill training without functional electrical stimulation|
16010008|NCT02812459|Other|Kinesio taping|Kinesio taping is a new taping modality which act diminishing pain.
16010009|NCT02812459|Other|Electrical Stimulation|Electrical stimulation therapy is a electrical current that allow patients diminish pain.
16010010|NCT02812446|Other|IAI infection|
16010011|NCT02812446|Other|Staphylococcus aureus nasal carriage infection|
16010012|NCT02812433|Drug|Sildenafil|sildenafil 2 mg/kg/dose per os twice a day for seven consecutive days (from day 2 of life to day 9 of life) if brain injury on day 2 of life
16010013|NCT02812433|Drug|Ora-Blend|Ora-Blend, 2 mg/kg/dose per os twice a day for seven consecutive days (from day 2 of life to day 9 of life) if brain injury on day 2 of life
16010014|NCT02812420|Biological|Durvalumab|Given IV
16010015|NCT02812420|Procedure|Therapeutic Conventional Surgery|Undergo cystectomy with pelvic lymph node dissection
16010016|NCT02812420|Biological|Tremelimumab|Given IV
16010017|NCT02812407|Device|Mucosal Impedance|"During the clinical endoscopy, the 2.13 mm catheter will be passed through the channel of the standard endoscope this is called an Intraluminal Impedance. The Intraluminal impedance (made by Sandhill Scientific) has not been approved by the Food and Drug Administration (FDA) but it is considered to be minimal risk related to using it. The catheter gives the investigators a reading at each level.
~The catheter will be placed on the esophageal mucosa 5 cm above the gastroesophageal junction (where the stomach and esophagus meet) for 5 second
~At 10 cm above the gastroesophageal junction the catheter will be placed for 5 seconds
~And at 20 cm"
16010018|NCT02812394|Drug|CVT-301 (Dose Level 1)|All subjects will receive a single dose of low-dose CVT-301 with a 1-day washout between the doses.
16010019|NCT02812394|Drug|CVT-301 (Dose Level 2)|All subjects will receive a single dose of high-dose CVT-301 with a 1-day washout between the doses.
16010020|NCT02812394|Drug|Sinemet®|All subjects will receive carbidopa/levodopa tablets administered every 8 hours.
16010021|NCT02812381|Procedure|KT|to aplicate neuromuscular bandage technique(KT)
16010022|NCT02812381|Procedure|SCS|To aplicate strain-counterstrain above trigger point
16010023|NCT02812368|Drug|Clonidine|
16010024|NCT02812368|Drug|Placebo (for clonidine)|Placebo pill manufactured to mimic clonidine
16010025|NCT02812355|Drug|Heparin|
16010026|NCT02812342|Drug|Tofacitinib ointment|Patients with AA (with at least 2 patches of alopecia involving the scalp), AT or AU will be treated with tofacitinib ointment for a maximum of 6 months. During treatment, patients will be evaluated every 4 weeks and effectiveness of the medication will be measured by changes in hair growth.
16010027|NCT02812329|Behavioral|HIV prevention videogame|Assess acceptability and efficacy of a HIV prevention videogame
16010028|NCT02812316|Device|HI-BRITE Large Diameter Rigid Gas Permeable Contact Lens|Approximately At least one hundred and forty (140) subjects (280 eyes) will be enrolled in this study at approximately two (2) clinical sites in Taiwan. All subjects will be fitted for and dispensed study lenses by each Investigator.
16010029|NCT02812303|Other|Centralized support for population health management activities|
16010030|NCT02812290|Procedure|Lung transplant biopsy bites.|In the second phase of the study, two biopsy bites from the same patient will be collected to assess tissue sampling variability.
16010031|NCT02812264|Behavioral|API App|Mobile application that uses API technology to deliver evidence-based weight loss intervention. Includes syncing with wearable fitness tracker and scale
16010032|NCT02812264|Behavioral|Non-API App|Mobile application that does not use API technology to deliver evidence-based weight loss intervention. Includes syncing with wearable fitness tracker and scale.
16010033|NCT02812264|Behavioral|fitness tracker|fitness tracker to monitor physical activity and sleep patterns that is connected to transfer data to app
16010034|NCT02812264|Behavioral|scale|Connected scale that will transfer weight information to app
16010035|NCT02812251|Drug|JNJ-61393215|JNJ-61393215 (projected dose levels as described above for Part 1) will be administered as an oral suspension.
16010036|NCT02812251|Drug|Placebo|Matching placebo will be administered.
16010037|NCT02812238|Dietary Supplement|Nicotinamide riboside (NR)|NR at dose of 1000mg/day will be given for a period of 7 days in a double blinded fashion either from the start of tx or after 1 week of placebo pills.
16010038|NCT02812238|Drug|Placebo|Placebo capsule daily for a period of 7 days in a double blinded fashion either from the start of tx or after 1 week of NR at a dose of 1000mg/day.
16010039|NCT02812225|Device|BrainPulse|Jan Medical's BrainPulse measures the brain motion caused by pulsatile blood flow from the cardiac cycle, referred to as the BrainPulse signal. The BrainPulse measures skull acceleration in response to the brain motion using an array of sensors placed on the head.
16010040|NCT02812212|Device|ultrasonography|bilateral ultrasonography to measure the antero-posterior renal pelvic diameter (APRPD) in both positions.
16010041|NCT02812212|Device|diuretic renography|diuretic renography to measure the cortical transit time.
16010042|NCT02812199|Device|Composite Removable Sinus Stent|Post-FESS bilateral implantation of sinus stent into middle meatus. Nasal tampon will be placed to stop bleeding. Stent will be removed after 14 - 28-day implantation, during self-crimp procedure induced by cold saline flush and safely pulled out. During implantation period patients will be examined endoscopically for inflammation, adhesions and middle turbinate position.
16010043|NCT02812199|Drug|adrenaline-lidocaine|adrenaline - lidocaine administration to minimize bleeding prior to stent removal (group 1 and group 2)
16010044|NCT02812199|Procedure|cold saline wash|nasal wash with cold saline prior to stent removal, to induce stent self-crimping.
16010045|NCT02812186|Procedure|Deep to Moderate NMB|"Rocuronium infusion will be paused and the Train of Four (TOF) monitor will be set to every 1-2 min. Once the patient has achieved a moderate NMB state (one to two twitches), the infusion of the muscle relaxant will be resumed at a low dose to maintain the patient at this level of blockade."
16010046|NCT02812186|Procedure|Moderate to Deep NMB|"Rocuronium infusion will be increased in increments of 0.1-0.2 mg/kg/hr. and the TOF monitor will be set to every 1-2 min. Once the patient has no twitches and a PTC of 0-1 (deep NMB) the infusion will be adjusted to maintain the patient at this level of NMB."
16010047|NCT02812186|Drug|Rocuronium|
16010048|NCT02812173|Device|suprapubic tube ex 2 day|balloon catheter for suprapubic bladder-drainage, suprapubic tube removal on the second day after the surgery
16010049|NCT02812173|Device|suprapubic tube ex 5 day|balloon catheter for suprapubic bladder-drainage, suprapubic tube removal on the fifth day after the surgery
16010050|NCT02812173|Device|transurethral catheter ex 5 day|transurethral catheter withdrawal removal on the fifth day after the surgery
16010051|NCT02812160|Device|Spatz3 Adjustable Balloon|An adjustable intragastric balloon for weight loss that can have the balloon volume increased or decrease as needed
16010052|NCT02812147|Drug|L-DOPS|Added as described in the Arm/Group Descriptions.
16010053|NCT02812147|Drug|Placebo|Added as described in the Arm/Group Descriptions.dded as described in the Arm/Group Descriptions.
16010054|NCT02812121|Drug|umbilical cord blood mesenchymal stem cells|
16010055|NCT02812108|Device|intracranial stent, flow diverter and coils|
16010056|NCT02812095|Procedure|Refeeding|when amount of feeding reach to 120mL/kg a day,
16010057|NCT02812082|Other|web-based patient education|
16010058|NCT02812082|Behavioral|questionnaire|
16010059|NCT02812069|Device|ThermaZone® Device|The device will be used to intraoperatively warm patients having minor-to moderate surgical procedures
16010060|NCT02812056|Drug|Alisertib|"Dose Escalation Phase:
~Starting dose of Alisertib: 30 mg by mouth 2 times a day on Days 1 - 7 each 21 day cycle.
~Dose Expansion Phase: Maximum tolerated dose from Dose Escalation Phase."
16010061|NCT02812056|Drug|TAK-228|"Dose Escalation Phase:
~Starting dose of TAK-228: 1 mg by mouth daily Days 3 - 18, with the exception of 2 mg daily Days 3 - 7 and 10 - 14 schedule in a 21 day cycle.
~Dose Expansion Phase: Maximum tolerated dose from Dose Escalation Phase."
16010062|NCT02812043|Device|1,064nm Long-pulsed Nd:YAG|Long-pulsed 1,064nm will be used for the treatment of onychomycosis which wll use 35-45 J/cm2 spot size 4, frequency 1 Hz for 2 passes on the infected nails
16010063|NCT02812043|Drug|Amorolfine|Amorolfine nail lacquer will be applied by the patient once a week on the infected nails
16010064|NCT02812030|Other|National Eye Institute Visual Functioning Questionnaire|Routine treatment plus visual functioning questionnaires
16010065|NCT02812017|Behavioral|Thirty Million Words- Well Baby|Through evidence-based strategies, the TMW-WB curriculum teaches parents how to harness the power of their words to build their child's brain and impact their child's learning trajectory.
16010066|NCT02812017|Other|Safety Starts at Home|A portion of the Safety Stars at Home set is shown. Demonstrating proven childproofing techniques and accident-prevention strategies, which unifies safety guidelines and shows caregivers how to take proactive measures at home. Many no- or low-cost safety alternatives are offered.
16010067|NCT02812004|Device|Ultra Q Reflex YAG laser (Ellex)|"Group 1 receives up to 2 sessions of vitreolysis performed with the Ultra Q Reflex YAG laser (Ellex). There is no cut off for total energy per treatment session.
~For the sham treatment in group 2, the physician quickly manipulates the light switch of the laser's slit lamp to create light flashes and simulate laser pulses."
16010068|NCT02811991|Drug|Paracetamol injection|325mg(32.5mL) or 500mg(50mL) iv q6h,4 doses in 24h.Infushion time≥15min.
16010069|NCT02811991|Drug|Normal Saline injection|32.5mL or 50mL iv q6h,4 doses in 24h.Infushion time≥15min.
16010070|NCT02811991|Drug|Morhpine PCA|Morphine PCA will be connected upon the first dose of study drug(roughly 30min prior to the completion of would suture). Morphine PCA is set as follows:1mg bolus every 5min with background infusion of 0.25mg/h and maximal dose<25mg/4h.
16010071|NCT02811978|Drug|Bortezomib|Participants will receive 1.3 mg/m^2 bortezomib on Days 1, 4, 8, and 11 of a 3 week cycle.
16010072|NCT02811978|Drug|Dexamethasone|Participants will receive Dexamethasone at a dose of 20 mg PO on the day of and the day after bortezomib dosing (Days 1, 2, 4, 5, 8, 9, 11, and 12 of each cycle).
16010073|NCT02811965|Other|Pillow Condition 1|The heel is offloaded by placing the heel on a standard hospital pillow.
16010074|NCT02811965|Other|Pillow Condition 2|The heel is offloaded by placing a standard hospital pillow under the calf suspending the heel above the hospital bed mattress.
16010075|NCT02811965|Device|Heel Foam Pillow|An economy heel offloading device constructed of egg shell foam.
16010076|NCT02811965|Device|Offloading Device A|Heel offloading device that utilizes open cell foam to offload the heel. Device has a published clinical study demonstrating effectiveness at reducing heel ulceration rate.
16010077|NCT02811965|Device|Offloading Device B|Heel offloading device that utilizes pressure absorbing filling to offload the heel. Device has a published clinical study demonstrating effectiveness at reducing heel ulceration rate
16010078|NCT02811965|Device|Offloading Device C|Heel offloading device that utilizes a similar pressure absorbing filling to Offloading Device B; however this device does not have published clinical literature demonstrating effectiveness at reducing heel ulceration in the clinic.
16010079|NCT02811952|Other|without intervention|without intervention
16010080|NCT02811939|Drug|Active Dronabinol|20 mg capsule of Dronabinol will be administered orally
16010081|NCT02811939|Drug|Active Pregnenolone|1.79 mg/kg of Pregnenolone will be administered sublingually (under the tongue)
16010082|NCT02811939|Drug|Placebo Dronabinol|Control: Placebo pill (no active cannabinoids) administered orally
16010083|NCT02811939|Drug|Placebo Pregnenolone|Control: Placebo given sublingually (under the tongue)
16010161|NCT02811289|Other|cold exposure|Acute cold exposure protocol using a water-conditioned cooling suit will be applied from time 120 to 300 min in protocol B
16071164|NCT02374567|Drug|Pyritinol|
16010084|NCT02811913|Other|repetitive transcranial magnetic stimulation (rTMS)|"3 types of interventions on different sessions
~session 1 - High frequency rTMS targeting contralesional sensory cortex
~session 2 - Low frequency rTMS
~session 3 - sham rTMS"
16010085|NCT02811913|Other|peripheral sensory stimulation|peripheral sensory electrical stimulation and vibration of the stroke-affected hand administered concurrently with each rTMS
16010086|NCT02811900|Procedure|Roux en Y gastric bypass|Laparoscopic RYGB is performed as following: a gastric pouch of approximately 30mL was obtained using successive firings of the Endo GIATM linear stapler, followed by the creation of an antecolic alimentary limb of 150cm and of a biliopancreatic limb of 75cm. A gastrojejunal anastomosis was fashioned with the PCEEA™ 28 circular stapler until 2012, and using the Endo GIA™ linear stapler afterwards. The mesenteric defect and Petersen's defect were closed using a non-absorbable running suture.
16010087|NCT02811900|Procedure|Sleeve gastrectomy|Laparoscopic SG is performed as following: after greater curvature mobilization, the gastric tube was calibrated over a 36F bougie and transection started approximately 5-6 cm from the pylorus toward the left diaphragmatic crus, using successive firings of 3.5- or 4.8-mm-high staples, depending on gastric thickness.
16010088|NCT02811900|Procedure|Gastric banding|Laparoscopic gastric banding is performed as following: a perigastric tunel is performed by blunt dissection and the banding is calibrated over the stomach.
16010089|NCT02811900|Procedure|Intragastric balloon|Flexible endoscopy is used to place intragastric balloon for a maximum interval of six months.
16010090|NCT02811887|Behavioral|Supervised exercise|A 12 week supervised and facility-based exercise training program. The program is facility based and supervised by a physiotherapist. The program runs 3 times weekly for 12 weeks. The exercise is group-based. The exercise program lasts approximately 1 hour and consists of a brief warm-up phase (bicycle ergometer at moderate intensity) followed by a circuit training program focusing on strength and endurance exercises of the large muscle groups (e.g. quadriceps).
16010091|NCT02811887|Other|Usual Care|Participants allocated to usual care will receive instructions related to healthy living, alcohol absenteeism, and benefits of increased physical activity. The instructions will be provided by a physical therapist and/or a nurse, and will be given according to recommendations and local and national guidance. The participants are offered continued regular visits at the rehabilitation clinic, but no supervised physical exercise.
16010092|NCT02811887|Behavioral|SMS-messages|"Participants allocated to SMS-messages will receive the same intervention as usual care (see above) AND regular text messages via SMS over a 12-week period.
~The text messages will be unidirectional and will serve as motivational information but will not allow two-way communication with a researcher or health professional about clinical management. The messages will provide information, motivation, and support to adhere to a healthy lifestyle, alcohol absenteeism, and physical activity and will reinforce the information and instructions received at the face-to-face information (usual care)."
16010093|NCT02811874|Behavioral|diabetes education|Diabetes education program includes: 4 theoretical sessions, 60 minutes long, taught once a week for 4 weeks, developed in the form of group classes, and given by one of the authors. The educational program content comprises (1) definition of diabetes, and identification of modifiable risk factors for type 2 diabetes, (2) non-pharmacological treatment, with emphasis on diet and exercise, (3) pharmacological therapy, including mechanism of action and side effects of anti-diabetic medications provided by the Brazilian public health system and (4) an overview of chronic diabetes complications.
16010094|NCT02811874|Behavioral|education in other areas|Four theoretical sessions related to education in other health areas, not related to diabetes, administered during 4 weeks
16010095|NCT02811861|Drug|lenvatinib|
16010096|NCT02811861|Drug|everolimus|
16010097|NCT02811861|Drug|pembrolizumab|
16010098|NCT02811861|Drug|Sunitinib|
16010099|NCT02811822|Drug|GMI-1271|
16010100|NCT02811809|Drug|Apalutamide|Apalutamide 240 mg (4 60mg tablets) daily
16010101|NCT02811809|Drug|IHT|Leuprolide 3-month depot 22.5 intramuscular dose
16010102|NCT02811796|Other|angio-based FFR estimation|The investigators will acquire specific angiograms to permit angio-based FFR (QFR) calculation. An independent corelab will estimate the QFR value. This value will be related to prognosis to verify if it is able to discriminate those at higher risk of adverse events.
16010105|NCT02811770|Other|kidney biopsy|
16010106|NCT02811757|Procedure|tenotomy|
16010107|NCT02811757|Procedure|tenodesis|
16010108|NCT02811744|Drug|11C-acetate|Participants will receive injection of radioactive tracer 11C-acetate and complete a PET/CT scan.
16010109|NCT02811731|Drug|CKD-330 16/5mg - B|
16010110|NCT02811731|Drug|Candesartan 16mg and Amlodipine 5mg|
16010111|NCT02811718|Behavioral|Stress Management Group 1|Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.
16010112|NCT02811718|Behavioral|Stress Management Group 2|Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.
16010113|NCT02811705|Other|Quality of life|Quality of life
16010114|NCT02811692|Drug|Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)|Administration by intravitreal injection
16010115|NCT02811679|Drug|Blinatumomab|Blinatumomab is a bispecific t cell engaging antibody targeting CD19 and CD3 approved for B cell acute lymphoblastic leukemia
16010116|NCT02811666|Device|Assessment of sarcopenia by CT-Scan|
16010117|NCT02811666|Device|hand gauge|
16010118|NCT02811653|Device|Brain MRI|
16010119|NCT02811653|Other|neuropsychological evaluation|
16010120|NCT02811653|Biological|Blood|
16010121|NCT02811640|Other|Study Participants|IAP will be observed and measured with a hand held Stryker Pressure Monitor during laparoscopic surgery and compared to the standard IAP measurements obtained with the insufflator at the time of PD catheter insertion
16010162|NCT02811289|Radiation|injection of 18FDG|I.v. injection of 18-fluorodeoxyglucose (18FDG) will be performed at time 270 min, followed by 30 min dynamic PET/CT scanning
16010163|NCT02811289|Radiation|injection of 11C-acetate|i.v. injection of 11C-acetate will be performed, followed by 20 min dynamic PET/CT scanning
16010164|NCT02811289|Radiation|[3-3H]-glucose|i.v. administration of 1.5 uCi/min of [3-3H]-glucose
16010122|NCT02811627|Drug|Memantine|Namenda (pill and the liquid) will be started at 5 mg/day doses to be titrated up 20 mg/day based on response and tolerability, as per the package insert instructions and based upon clinical titration in other clinical trials for a period of 12 weeks. Namenda XR will be started at 7 mg/day to be titrated up to 28mg/day based on response and tolerability, as per package insert instructions and based upon clinical titration in other clinical trials for a period of 12 weeks.
16010123|NCT02811627|Device|Magnetic Resonance Imaging|The subjects will undergo an MRI assessment after baseline behavioral assessment. The session will involve a structural MRI scan, single voxel spectroscopy scans and resting state functional MRI. The subjects will be started on memantine post the imaging session. The imaging will be carried out on a research dedicated 3 Tesla (3T) Siemens Trio Scanner at the University of Missouri Brain Imaging Center by trained personnel.
16010124|NCT02811614|Procedure|Endoscopic Evacuation|Endoscopic surgery for treatment of supratentorial hypertensive intracerebral hemorrhage.
16010125|NCT02811614|Procedure|Stereotactic Aspiration|Using image guidance to aspirate hematoma.
16010126|NCT02811614|Procedure|Craniotomy|Craniotomy with a big bone flap to evacuate intracerebral hematoma.
16010128|NCT02811588|Device|Non-invasive ventilation|
16010129|NCT02811575|Other|Biopsy|Ileon and colon biopsy
16010130|NCT02811562|Device|manikin|
16010131|NCT02811562|Device|fiberoptic bronchoscope|
16010132|NCT02811562|Device|pentax-airwayscope|
16010133|NCT02811549|Device|HiResolution Bionic Cochlear Implant|HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults with eligible hearing profile.
16010134|NCT02811536|Device|optical coherence tomography angiography|Imaging with optical coherence tomography angiography
16010135|NCT02811523|Drug|Doxorubicin|Doxorubicin by In Vivo Lung Perfusion
16010136|NCT02811510|Drug|Placebo|Placebo pill (no active cannabinoids)
16010137|NCT02811510|Drug|Dronabinol|10 mg capsule of Dronabinol will be administered orally.
16010138|NCT02811497|Drug|Azacitidine|
16010139|NCT02811497|Drug|Durvalumab|
16010140|NCT02811484|Drug|Exenatide-LAR plus Dapagliflozin placebo|Exenatide-LAR 2 mg every week x 24 weeks plus Dapagliflozin placebo x 52 weeks and behavioral therapy.
16010141|NCT02811484|Drug|Exenatide-LAR plus Dapagliflozin|Exenatide-LAR 2 mg every week x 24 weeks plus Dapagliflozin 5 mg x 2 weeks, then 10 mg for 22 weeks and behavioral therapy.
16010142|NCT02811484|Drug|Insulin Titration|Basal insulin titration up to 12 weeks followed by basal-bolus regimen in those with HbA1c>8%
16010143|NCT02811484|Behavioral|Behavioral Therapy|Subjects will be seen by a registered dietitian and receive nutritional and lifestyle counseling according to a web-based weight management program.
16010144|NCT02811458|Behavioral|Transdiagnostic Cognitive-Behavioral Therapy|Treatment in the Transdiagnostic CBT condition will consist of 12 weekly 2-hour sessions following the manualized treatment protocol including psychoeducation, cognitive restructuring, exposure and relapse prevention.
16010145|NCT02811432|Other|Kangaroo mother care|Skin-to-skin care (target: at least 18 hours per day)
16010146|NCT02811432|Other|Standard care|Incubator or radiant warmer until neonate meets stability criteria; once stable (WHO indication for KMC certain), the baby can transition to routine (intermittent) KMC
16010147|NCT02811419|Device|i-scan|examination will be performed with i-scan digital enhancement
16010148|NCT02811419|Device|standard high-definition white light|examination will be performed with high-definition white light
16010149|NCT02811406|Procedure|Receives IV albumin infusion|"IV albumin 20% 50 mL for every 1L of ascitic fluid drained. Blood pressure and heart rate are recorded every four hours in both groups in the first 48 hours.
~If hypotension occurs (defined as fall in systolic blood pressure of > 20 mmHg from baseline) during drainage, drain is clamped and the patient will be clinically evaluated for cause of hypotension. If no other causes of hypotension are found and patient remains asymptomatic, repeat blood pressure measurement in 30 minutes. If blood pressure maintains > 90/50 mmHg after 30 minutes and patient is asymptomatic, continue drainage and patient stays in the study. If patient remains hypotensive (BP < 90/50) or develops symptomatic hypotension, then the patient will be taken off study and the hypotension managed as clinically indicated."
16010150|NCT02811406|Biological|Do not receive IV albumin infusion|"No IV albumin infusion. Blood pressure and heart rate are recorded every four hours in both groups in the first 48 hours.
~If hypotension occurs (defined as fall in systolic blood pressure of > 20 mmHg from baseline) during drainage, drain is clamped and the patient will be clinically evaluated for cause of hypotension. If no other causes of hypotension are found and patient remains asymptomatic, repeat blood pressure measurement in 30 minutes. If blood pressure maintains > 90/50 mmHg after 30 minutes and patient is asymptomatic, continue drainage and patient stays in the study. If patient remains hypotensive (BP < 90/50) or develops symptomatic hypotension, then the patient will be taken off study and the hypotension managed as clinically indicated."
16010151|NCT02811393|Other|Assess muscle function|Assess muscle function with hand grip test and sit and stand test
16010152|NCT02811380|Device|BIP CVC|BIP CVC catheterization to minimize risk of infections for venous access during and after elective large surgery
16010153|NCT02811380|Device|Uncoated Standard CVC|Standard CVC catheterization for venous access during and after elective large surgery
16010154|NCT02811367|Device|HPV test|Women will perform the HPV self-test and will also undergo a physician-performed HPV test.
16010155|NCT02811354|Drug|AZD9291|oral administration as a single daily dose of 80 mg
16010156|NCT02811341|Drug|Scopolamine Hydrobromide|
16010157|NCT02811341|Drug|normal saline|
16010158|NCT02811315|Other|Observational. Non interventional study|Observational. Non interventional study
16010159|NCT02811302|Device|Capnostream Monitor|Capnography and pulse oximetry monitoring data will be collected for up to 48 hours while patients are on the hospital ward. In addition, a 1-month follow up will be completed.
16010160|NCT02811289|Drug|Mirbetriq (Mirabegron)|50mg of Mirabegron will be administered orally at time 0 in protocol A.
16071165|NCT02374567|Drug|Piracetam|
16010165|NCT02811289|Other|[U-13C]-palmitate|i.v. administration of 0.08 umol/kg/min of [U-13C]-palmitate
16010166|NCT02811289|Other|2H-Glycerol|i.v. administration of 0.05 µmol/kg/min of 2H-glycerol
16010167|NCT02811276|Other|Diet|The High-Protein Diet Group will receive a eucaloric diet composed of 35% of carbohydrate, 40% of protein, and 25% of lipid constructed around a soy protein-based meal replacement (Almased®) for one and a half day. Participants will consume 1 gram ± 0.1 of Almased® per kg of body weight mixed with linseed oil and skim milk in their breakfast, lunch and dinner. Two snacks (afternoon and evening) composed of 1 gram ± 0.1 of Almased® per kg of body weight mixed with vegetable juice and linseed oil will also be provided.
16010168|NCT02811263|Drug|Normal saline placebo|Equal volume of normal saline to be used as placebo
16010169|NCT02811263|Drug|Erythropoietin|Epogen drawn from commercially available single dose 4000U/mL vials
16010170|NCT02811250|Radiation|Stereotactic radiotherapy 4 x 8 Gy|
16010171|NCT02811250|Radiation|Stereotactic radiotherapy 5 x 8 Gy|
16010172|NCT02811250|Radiation|Stereotactic radiotherapy 4 x 10 Gy|
16010173|NCT02811250|Radiation|Stereotactic radiotherapy 4 x 12 Gy|
16010174|NCT02811237|Other|HESTIA|"Management based on the HESTIA rule:
~If the rule is negative, meaning that patient meet none of the exclusion criteria of the rule, the proposed management will be outpatient care.
~In the other cases, the patient will receive in-hospital care.
~Any reason for management (hospitalization or outpatient treatment) not based on the recommendation will be explained and documented in the e-CRF."
16010175|NCT02811237|Other|sPESI|"Management based on the simplified PESI score:
~If the sPESI score =0, the proposed management will be outpatient care.
~In the other cases, the patient will receive in-hospital care.
~Any reason for management (hospitalization or outpatient treatment) not based on the recommendation will be explained and documented in the e-CRF."
16010176|NCT02811198|Other|No intervention|
16010177|NCT02811185|Drug|[F-18]-Fludeoxyglucose|Radiopharmaceutical imaging agent
16010178|NCT02811172|Other|BEhavior of biomarkers during pregnanCy and lactatiOn|
16010179|NCT02811159|Drug|Telapristone acetate|Telapristone acetate, orally, once daily for three 18-weeks courses separated by an ODI.
16010180|NCT02811146|Device|Bilevel Positive Pressure Airway|Heart rehabilitation with noninvasive ventilation, for 12 weeks, 3 times a week
16010181|NCT02811146|Other|Heart rehabilitation|Heart rehabilitation, for 12 weeks, 3 times a week
16010182|NCT02811133|Drug|Inositol|Subjects will receive inositol
16010183|NCT02811120|Other|venepuncture only|single venepuncture
16010184|NCT02811107|Other|Questionnaires|Completion of questionnaires on tablet computers in the preoperative area by 6 nurse anesthetists, 1 hospital physician and 1 resident physician.
16010185|NCT02811094|Other|polymerase chain reaction (PCR) technique of blood transcriptome analysis|this study (LUMIER2 study) is to test the hypothesis that a test score or prognostic transcriptomic allows to discriminate clinically quiescent or patients who will not present a push of Systemic Lupus Erythematosus
16010186|NCT02811081|Procedure|Passive Deflation|In the control group, residual carbon dioxide gas was evacuated by the routine method using passive exsufflation through the port site at the end of surgery.
16010187|NCT02811081|Procedure|Normal Saline Instillation|In the normal saline instillation group, in addition to the routine method, the patients were placed in the Trendelenburg position (30°), isotonic normal saline (20 ml/kg of body weight) was infused in the sub-diaphragmatic region at the end of surgery.
16010188|NCT02811081|Procedure|Normal Saline Instillation + Pulmonary Recruitment|In the combined intervention group, in addition to the routine method, the patients were placed in the Trendelenburg position (30°), and a pulmonary recruitment maneuver was performed after instillation of isotonic normal saline (20 ml/kg of body weight) in the sub-diaphragmatic region at the end of surgery.
16010189|NCT02811068|Other|venepuncture|single venepuncture
16010190|NCT02811055|Biological|Blood sampling|Blood sampling for Plasma aldosterone, Plasma cortisol, plasma renin, plasma electrolytes after before and after administration of Aprepitant 80 mg once per day during 14 days or Administration of placebo once per day during 14 days
16010191|NCT02811055|Procedure|Blood Pressure Measurement|Blood Pressure Measurement before and after Administration of Aprepitant 80 mg once per day during 14 days or administration of placebo once per day during 14 days
16010192|NCT02811055|Device|electrocardiogram|Electrocardiogram before and after Administration of Aprepitant 80 mg once per day during 14 days or administration of placebo once per day during 14 days
16010193|NCT02811055|Procedure|orthostatic test|Orthostatic test after Administration of Aprepitant 80 mg once per day during 14 days or administration of placebo once per day during 14 days
16010194|NCT02811055|Drug|Administration of Aprepitant|Administration of Aprepitant 80 mg once per day during 14 days
16010195|NCT02811055|Drug|Administration of placebo|Administration of placebo once per day during 14 days
16010196|NCT02811042|Device|Ambu AuraOnce|Oropharyngeal leak pressure was determined by closing the expiratory valve of the anaesthesia breathing system and a fixed gas flow of 3 l minute-1. The airway pressure at which an equilibrium was reached was noted (maximum allowed 40 cm H2O).
16010197|NCT02811042|Device|Ambu AuraGain|The airway tube view was scored using an established scoring system (4=only vocal cords visible; 3=vocal cords plus posterior epiglottis; 2=vocal cords plus anterior epiglottis; 1=vocal cords not seen)
16010198|NCT02811029|Behavioral|measurement of phonology|measurement of phonology will be assess using BILO-3, EDA, VS and VL tests
16010199|NCT02811016|Drug|Budesonide 200|200 µg inhaled at 7:00 a.m. and 7 p.m.
16010200|NCT02811016|Drug|Budesonide 800|800 µg inhaled at 7:00 a.m. and 7 p.m.
16010201|NCT02811016|Drug|Placebo|Placebo Inhalation at 7:00 a.m. and 7 p.m.
16010202|NCT02811003|Device|Rotation Medical Bioinductive Implant|Placement of bioinductive implant over repair of insertional Achilles tendinopathy
16010203|NCT02810990|Drug|Bosutinib|"Bosutinib is given orally accordingly with this scheme:
~A. 200 mg OD: starting dose (wash-in period) at week 1 and week 2 B. 300 mg OD: from week 3 to the end of week 16
~At the end of week 12 evaluation of molecular response (BCR-ABL1 level by RT-Q-PCR).
~Bosutinib dose is then managed as follows :
~C1. if BCR-ABL1 ≤1% at week 12: 300 mg OD from week 17 to week 52 C2. if BCR-ABL1 > 1% at week 12: 400 mg OD from week 17 to week 52
~All the responsive patients who are still on Bosutinib at the end of week 52, will continue Bosutinib at the same dose (300 mg OD or 400 mg OD) for the next two years ( if tolerated and in absence of safety concerns)."
16010204|NCT02810977|Device|Ultrasound|Ultrasound assessment of gastric content and volume
16010205|NCT02810964|Drug|Sulforaphane Nutraceutical|Sulforaphane Nutraceutical 6 tablets by mouth daily
16010206|NCT02810964|Drug|Identical-appearing Placebo|Identical-appearing Placebo 6 tablets by mouth daily
16010208|NCT02810938|Device|Ablation of atrial flutter|Ablation of atrial flutter using IntellaTip Mifi 8 mm technology in combination with Maximum voltage-guided ablation approach
16010209|NCT02810925|Procedure|PENS T6|Patients undergo percutaneous electrical stimulation of dermatome T6, weekly, during 12 weeks.
16010210|NCT02810925|Procedure|TENS T11/T12|Patients undergo transcutaneous electrical stimulation of dermatomes T11-T12, weekly, during 12 weeks.
16010211|NCT02810925|Dietary Supplement|Hypocaloric 1200 Kcal/day diet|Patients follow a Hypocaloric 1200 Kcal/day diet during 12 weeks.
16010212|NCT02810925|Dietary Supplement|Normocaloric 2000 Kcal/day diet|Patients follow a Normocaloric 2000 Kcal/day diet during 12 weeks.
16010213|NCT02810912|Other|the effect of surgical position|Investigators do not have intervention in the observation study. Investigators only use the MII-pH catheter to observe the episodes of gastric regurgitation in patients receiving supraglottic airway device under general anesthesia. Thus, investigators are going to observe the effect of surgical position change, body weight, surgical time. And investigators will have a control group, which patients undergo elective surgeries without surgical position change, no longer surgical time, and normal range of body weight.
16010214|NCT02810899|Drug|dexmedetomidine|A loading dose dexmedetomidine (0.5 ug/kg IV infused in 15 minutes) will be administered after anesthesia induction, followed by a continuous infusion at a rate of 0.5 ug/kg/h until the closure of the brain duramater at the end of surgery.
16010215|NCT02810899|Drug|normal saline|Normal saline will be administered in the same rate, volume and duration as that in the dexmedetomidine group
16010216|NCT02810886|Drug|68Ga-(HBED-CC)-PSMA|68Ga-PSMA-ligand intravenous administration duration is around one minute. Once the patient is injected, the tracer needs 60 minutes to be evenly distributed through the body. PET/CT images will then be performed.
16010217|NCT02810873|Device|Positron Emission Mammography|Undergo PEM Positron Emission Mammography scan
16010218|NCT02810873|Device|Positron Emission Tomography|Undergo PET Positron Emission Tomography scan
16010219|NCT02810873|Radiation|Fludeoxyglucose F-18|Undergo Fludeoxyglucose F-18 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan
16010220|NCT02810873|Drug|Copper Cu 64 TP3805|Undergo copper Cu 64 TP3805 PET (Positron Emission Tomography) /PEM (Positron Emission Mammography) scan
16010221|NCT02810860|Procedure|Laparoscopic cholecystectomy|Administration of a disease-specific and generic PROMs survey to patients undergoing Laparoscopic Cholecystectomy
16010222|NCT02810847|Device|I-Bit plus|The study will treat amblyopia (lazy eye) using 3-D computer technology and active shutter glasses. Computer games and DVD's are viewed through the active shutter glasses and are specially prepared to preferentially stimulate the lazy eye; the child can only play the game accurately if they are using their lazy eye.
16010223|NCT02810834|Behavioral|Walking/Running program|"Participants will receive a behavioral intervention that consists of a school-based, walking/running/jogging program. Participants work to accumulate miles towards a goal of at least 100 miles, over the course of the school year. Program will be implemented through a champion in the school and structured/scheduled according to the schools resources (before, during, or after school). Miles are tracked at the school level, and incentives are provided for participants' completion of set milestones (25, 50, 75, and 100 miles).
~The intervention will run over two school years (approximately 16 months)"
16010224|NCT02810834|Behavioral|Classroom physical activity break program|"Participants will receive a behavioral intervention that consists of a classroom-based, physical activity break program. Classroom teachers, paraprofessionals, and other school staff will lead short (5-15 minute) activity breaks that include both higher intensity (ex. jumping jacks, squats) and low-intensity (ex. stretching, yoga) activities. Classrooms will be encouraged to integrate at least one short break per day. Activities are connected to national Common Core academic standards so that breaks can be integrated with academics.
~The intervention will run over two school years (approximately 16 months)"
16010225|NCT02810808|Procedure|1+PRN|PRN intravitreal injections of Ranibizumab 0.5mg guided by BCVA stabilization after the injection of the same does at the first month.
16010226|NCT02810808|Procedure|3+PRN|PRN intravitreal injections of Ranibizumab 0.5mg guided by BCVA stabilization after the first three monthly intravitreal injections of the same does.
16010227|NCT02810808|Drug|Ranibizumab|Ranibizumab - a recombinant, humanized monoclonal antibody Fab that neutralizes all active forms of VEGF-A was recently approved by the Food and Drug Administration for the treatment of all angiographic subtypes of subfoveal neovascular age-related macular degeneration
16010228|NCT02810795|Other|Diagnostic detection of coronary artery disease|Myocardial perfusion defect on dynamic CT perfusion imaging, and diagnostic accuracy as compared invasive FFR.
16010229|NCT02810782|Drug|Phenobarbital|Phenobarbital per os
16010230|NCT02810782|Drug|Chlorpromazine|Chlorpromazine per os
16010231|NCT02810782|Drug|Morphine|Morphine per os
16010232|NCT02810769|Dietary Supplement|Berry drink|Cold pressed berry drink standardised to contain 500mg of berry polyphenols
16010233|NCT02810769|Dietary Supplement|Control|Sugar matched control containing berry flavouring and no phytochemicals
16010234|NCT02810769|Dietary Supplement|Powdered berry drink|Berry drink made from a powder concentrate standardised to contain 500mg of polyphenols
16010235|NCT02810756|Drug|New Pazopanib formulation|
16010238|NCT02810730|Procedure|Pancreatic MRI|Pancreatic MRI in the 6 months following the first consultation
16010273|NCT02810418|Drug|Nab-Paclitaxel|Administered intravenously (IV) on days 1 and for Arms A1, A2 and B1 on day 8 of each 14-21 day cycle for a maximum of 2 (Arms A1, A2 and B1) or 3 (Arm B2) cycles
16010274|NCT02810418|Device|Mesothelin Expression|Research blood test for Arm B1 eligibility
16010431|NCT02809196|Behavioral|3: Tailored SMS program implicating friend, not mother|
16010239|NCT02810717|Device|theta-burst stimulation using a MagPro X1000|TBS over left and right dorsolateral prefrontal cortex for a period of three weeks. iTBS over left DLPFC: 3-pulse 50 Hz bursts will be given every 200ms (at 5 Hz) in 2-second trains with an inter-train interval of 8 seconds. Trains will be repeated 20 to reach a total number of 600 pulses per session. cTBS over right DLPFC: cTBS will comprise uninterrupted bursts to reach a total number of 600 pulses per session. Two sessions per day, separated by 60 minutes; 30 Sessions in total over 3 weeks.
16010240|NCT02810717|Device|sham stimulation using a MagPro X1000|Sham TBS with the coil set at 45° against the skull will be performed over left and right dorsolateral prefrontal cortex for a period of three weeks
16010241|NCT02810704|Drug|Enteric Coated Aspirin|
16010242|NCT02810704|Drug|Warfarin|
16010243|NCT02810704|Drug|Rivaroxaban|
16010244|NCT02810691|Dietary Supplement|Soluble fiber supplementation|Two different doses of psyllium powder will be diluted in 250 ml of orange-flavored water and drink in 5 minutes before breakfast.
16010245|NCT02810691|Dietary Supplement|Placebo (for fiber supplementation)|Placebo will consist of 250 ml of orange-flavored water to be drink in 5 minutes before breakfast.
16010246|NCT02810678|Other|Latent Tuberculosis Infection program evaluation & diagnosis|
16010247|NCT02810665|Behavioral|Visual acuity measurement by ETDRS chart|All participants must complete VA measurement of the study eye using 3 charts including the original ETDRS alphabet, ETDRS Landolt C, and ETDRS numeric charts for 2 times, at least 30 minutes apart.
16010248|NCT02810652|Other|Usual Care|Usual Care participants will not meet with a geriatric clinician perioperatively, though they may receive a geriatric consult at their request or at the discretion of their treating cancer team.
16010249|NCT02810652|Other|Perioperative Geriatrics Intervention|Patients randomized to the perioperative geriatrics intervention will undergo evaluation with a board-certified Massachusetts General Hospital (MGH) geriatric clinician, both pre- and post-operatively. The geriatric clinician visits will focus on the following issues: comorbidity, polypharmacy, nutrition, physical and mental function, and social support.
16010250|NCT02810626|Device|BrightMatter™ products|"BrightMatter™ Plan (BMP): BMP is a software that enables surgeons to plan their neurosurgery preoperatively. BMP automatically generates whole brain tractography and highly accurate fusion of anatomical MRI and DTI images.
~BrightMatter™ Bridge (BMB):BMB involves offering SMI's MRI expertise to ensure a smooth workflow in neuroimaging including DTI to ensure optimized protocols are used to acquire the DTI images. Once the images are acquired, they are evaluated for their quality in real time using a quality control (QC) algorithm. The QC allows quality assessment of DTI images at the time-of-scan allowing for immediate correction while the patient is still there and reduces the need for patient re-scan.
~BrightMatter™ Guide (BMG): BMG is a neuro-navigation system that utilizes the DTI information and the trajectory planned by the surgeon in BMP pre-operatively, but bringing it into the operating room intraoperatively."
16010251|NCT02810600|Other|Gallium-68 DOTA TATE PET scan|One PET/CT scan using Gallium-68 DOTA TATE
16010252|NCT02810587|Drug|Topical antibiotics following injection|Either receive or not receive topical antibiotics following intravitreous injection
16010253|NCT02810574|Behavioral|Cognitive training|
16010254|NCT02810574|Device|Noninvasive brain stimulation (active)|Neuroconn DC-STIMULATOR PLUS
16010255|NCT02810574|Device|Noninvasive brain stimulation (sham)|Neuroconn DC-STIMULATOR PLUS
16010256|NCT02810561|Other|No Intervention|No intervention was completed with this study.
16010257|NCT02810548|Procedure|OFD alone|Periodontal surgical cleaning procedure
16010258|NCT02810548|Drug|Platelet rich Fibrin|Natural platelet concentrate rich in growth factors
16010259|NCT02810548|Drug|Nanohydroxyapatite|Synthetic bone graft
16010260|NCT02810535|Other|Observation|"Visit 1:
~Physical examination (inspection of nasopharynx, auscultation of heart and lungs)
~Completion of a Health Questionnaire
~Lung function testing with spirometry
~Skin prick test
~Visit 2:
~Physical examination (inspection of nasopharynx, auscultation of heart and lungs)
~Measurement of nitric oxide in expired air (FeNO)
~Taking nasal secretion samples with a cotton carrier for 15 min
~Nasal provocation test with dust mite
~Blood sample collection to define blood count, IgE and specific IgE"
16010261|NCT02810522|Device|OneTouch Select® Plus Glucose Test Strips|
16010262|NCT02810496|Genetic|blood collection for mutation characterization|
16010263|NCT02810483|Drug|Topiramate|"Increase phase. The starting dose is 50 mg / day with gradual increase in dose to 50 mg / week until the end of the 3rd week.
~Dose of study:
~200mg for 5 weeks.
~Decrease phase:
~The 9th week, 100mg for 4 days then 50mg for 3 days."
16010264|NCT02810483|Drug|Placebo Comparator|"ncrease phase. The starting dose is 50 mg / day with gradual increase in dose to 50 mg / week until the end of the 3rd week.
~Dose of study:
~200mg for 5 weeks.
~Decrease phase:
~The 9th week, 100mg for 4 days then 50mg for 3 days."
16010265|NCT02810470|Dietary Supplement|Fortimel Compact Protein|Each product will be tested by all patients spread over 2 days. A first half of volunteers will start the testing process with the beverages at day 1 and continue with the creams at day 2. The second half of volunteers will process inversely (day 1 = creams, day 2 = beverages). The test order of flavors will be randomly allocated to the volunteers among the list of all possible combinations.
16010266|NCT02810470|Dietary Supplement|Fortimel Cream|Each product will be tested by all patients spread over 2 days. A first half of volunteers will start the testing process with the beverages at day 1 and continue with the creams at day 2. The second half of volunteers will process inversely (day 1 = creams, day 2 = beverages). The test order of flavors will be randomly allocated to the volunteers among the list of all possible combinations.
16010267|NCT02810457|Drug|FKB238 (bevacizumab)|
16010268|NCT02810457|Drug|Avastin (bevacizumab)|
16010269|NCT02810457|Drug|Paclitaxel|
16010270|NCT02810457|Drug|Carboplatin|
16010271|NCT02810444|Biological|IgG Next Generation (BT595)|
16010272|NCT02810418|Drug|LMB-100|Arms A1 and A2 (short infusion): Administered intravenously (IV) on days 1, 3 and 5 of a 21 day cycle for a maximum of 2 cycles Arm B1 (continuous infusion): Administered IV for 24, 48, 72 or 96 hours continuously on the first 1 - 4 days or 24 hour infusions on days 1 and 4 (depending on dose level) of each 21 day cycle for a maximum of 2 cycles. Arm B2 (continuous infusion): Administered IV for 24,48, 72 or 96 hours continuously on the first 1 - 4 days or 24 hour infusions on days 1 and 4 (depending on dose level) of each 14 day cycle for a maximum of 3 cycles.
16071166|NCT02374567|Drug|Donepezil|
16010275|NCT02810418|Drug|LMB-100|A 40 mcg/kg loading dose of LMB-100 is administered over 30 minutes immediately prior to the start of each long infusion.
16010276|NCT02810392|Drug|Intranasal Insulin|Delivery is with the Vianase device, 20 IU twice daily for 3 weeks.
16010277|NCT02810392|Drug|Intranasal saline|Delivery is with the Vianase device, 0.5 cc of normal saline
16010278|NCT02810379|Procedure|written informed consent|
16010279|NCT02810379|Procedure|video+written informed consent|
16010280|NCT02810366|Other|Physician versus Computer Coded Verbal Autopsy|Comparing the performance of computer coded verbal autopsies (CCVA) to physician coded verbal autopsies (PCVA) at the population level.
16010281|NCT02810353|Device|Differential rapid maxillary expansion|Twenty-five patients will be submitted to rapid maxillary expansion using the expander with differential opening. Appliance anchorage will be provided by bands adapted either on the maxillary first permanent molars or on the second deciduous molars and circumferential clamps will be bonded to the maxillary deciduous canines. If the maxillary second deciduous molars will be banded, a lingual extension wire will be placed in the partially erupted maxillary first permanent molars. Both anterior and posterior screws will be activated with a complete turn a day during 6 days. Then, only the anterior screw will be additionally activated for 4 more days. After the active period of RME, the screws will be fixed with acrylic resin and the appliance will be kept as a retainer for 6 months.
16010282|NCT02810353|Device|Conventional rapid maxillary expansion|Twenty-five patients will undergo rapid maxillary expansion using conventional Hyrax expander. Bands will be adapted either on the maxillary first permanent molars or on second deciduous molars and circumferential clamps will be bonded to the maxillary deciduous canines. Similarly to the experimental group, a lingual extension wire will be placed in the partially erupted maxillary first permanent molars if the maxillary second deciduous molars will be banded. The expander screw will be activated with a complete turn a day during 6 days. After the expansion active phase, the screw will be fixed with acrylic resin and the appliance will be kept in the dental arch as a retainer for 6 months.
16010283|NCT02810340|Biological|Adjuvanted MCV-5|Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM), and 125 μg Al3+adjuvant.
16010284|NCT02810340|Biological|Non-Adjuvanted MCV-5|Contains 5 μg each of N. meningitidis A, C, Y, W, and X polysaccharides, 2.42 mg sucrose, 0.40 mg sodium citrate, 0.098 mg tris (trometamol), 7.8 to 33.4 μg tetanus toxoid, and 11.7 to 50.1 μg cross reactive material of diphtheria toxin (CRM).
16010285|NCT02810340|Biological|Menactra®|Menactra® vaccine was a clear to slightly turbid solution supplied in a 0.5 mL single dose vial. Each 0.5 mL dose of vaccine was formulated in sodium phosphate buffered isotonic sodium chloride solution to contain four mcg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 μg of diphtheria toxoid protein carrier and residual amounts of formaldehyde of less than 2.66 μg (0.000532%), by calculation.
16010286|NCT02810327|Genetic|Genetic Sequencing|Sequencing of the SERPINA1 gene
16010287|NCT02810314|Behavioral|neuropsychological battery|neuropsychological battery including cognitive and behavioural tests
16010288|NCT02810314|Other|resting state functional magnetic resonance image (rs-fMRI)|rs-fMRI
16010289|NCT02810301|Other|Probiotic ES1|B. longum ES1 is formulated for oral use as Glutagest. Each capsule contains 1 billion CFU of B. longum. The capsules are off-white in color and cylindrical in shape with approximate dimensions of 19 mm x 6.63 mm and a weight of 500 mg. Non-medicinal ingredients consist of the common excipients filler rice maltodextrin, lubricant stearic acid, and encapsulating agent vegetable cellulose.
16010290|NCT02810301|Other|Placebo|The placebo is composed of the same non-medicinal ingredients as the investigational product (IP) (i.e. rice maltodextrin, stearic acid, and vegetable cellulose) but it does not contain the active ingredient B. longum ES1. The placebo is designed to resemble the IP in terms of physical appearance.
16010291|NCT02810288|Behavioral|Voluntarily response all items in the questionnaire.|"The study type is a cross-sectional study, by means of electronic self-administered survey as online questionnaire sent by e-mail.
~The questionnaire for the survey was developed with reference to previously published guidelines on the design of questionnaire surveys. The content validity of the questionnaire was verified by review of clinicians not participating into the project and by a statistician."
16010292|NCT02810275|Drug|Folinic Acid|Folinic acid 5 mg, taking in the morning, daily, during four weeks
16010293|NCT02810275|Drug|Placebo|Placebo capsule received 1 tablet, taking in the morning, during four weeks
16010294|NCT02810262|Other|Bone metastases biopsy|The vast majority of bone biopsy are performed under CT-scan. In some rare cases, the histology will be performed during surgery (either biopsy of the bone metastasis or surgical piece when treating a fracture).
16010295|NCT02810249|Other|No intervention used|
16010296|NCT02810236|Procedure|Ultrasound|Ultrasound will be performed.
16010297|NCT02810236|Behavioral|Discussion|Radiologist will discuss with the patient the findings on mammogram.
16010298|NCT02810223|Biological|CART-19|2 to 5 x 10(6) autologous CART-19 transduced cells per kg body weight, with a maximum dose of 2.5 x 10(8) autologous CTL019 transduced cells via intravenous infusion.
16010299|NCT02810210|Other|fundus examination|"In cohort 3, a fundus examination will be carried in addition to the current medical practice.
~This exam is part of current medical practice for other groups."
16010300|NCT02810210|Other|Head ultrasound|"In cohort 3, a head ultrasound will be carried in addition to the current medical practice.
~This exam is part of current medical practice for other groups."
16010301|NCT02810197|Behavioral|Psychopathological assessment|
16010302|NCT02810197|Behavioral|Neuropsychological assessment|
16010303|NCT02810197|Device|Functional magnetic resonance imaging (fMRI)|
16010304|NCT02810184|Radiation|cone-beam computed tomography (CBCT)|additional CBCT scan at 24 and 36 months, for analysis of evolution of bone volume
16010305|NCT02810171|Behavioral|Cognitive Behavioral Therapy|A therapy which teaches patients coping skills to manage anxiety and gradually yet repeatedly exposes patients to anxiety-provoking thoughts and situations until the anxiety habituates/diminishes.
16010306|NCT02810171|Behavioral|Relaxation Therapy|An active control therapy with minimal effects on anxiety symptoms. If randomized to this therapy, participants will have the option to cross-over to CBT once the relaxation therapy arms has been completed.
16010311|NCT02810093|Other|retrospective medical records analyze|Ten thousand medical records (between years 2000 and 2016) will be analyzed
16010312|NCT02810067|Procedure|Tunnel + AlloDerm|A coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (AlloDerm).
16010313|NCT02810067|Procedure|Tunnel + Novomatrix|A coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (Novomatrix).
16010314|NCT02810054|Procedure|Minimally Invasive Surgical Techniques (MIST)|Using minimally invasive surgical techniques.
16010315|NCT02810054|Procedure|Enamel Matrix Derivative (EMD)|Use of enamel matrix derivative for the treatment of intrabony periodontal defects.
16010316|NCT02810041|Dietary Supplement|yoghurts enriched with XXS|
16010317|NCT02810041|Dietary Supplement|yoghurts non enriched with XXS|
16010318|NCT02810028|Behavioral|Acceptance and Commitment Therapy (ACT)|Acceptance and Commitment Therapy (ACT) is a form of cognitive behavioural therapy focused explicitly on promoting psychological flexibility. An ACT programme suits the aims of the study because it targets avoidance of distress, promotes acceptance of illness through motivating meaningful activity outside of illness, improves the processes that underlie beliefs rather than by directly challenging beliefs, thus reducing possible trivialisation of the understandable distress caused by living with MD.
16010319|NCT02810015|Drug|Botulinum Toxin Type A|BTX-A will be reconstituted as directed by the manufacturer. 2.5 mL of diluent (0.9% Saline) per 100 U vial will be used to reconstitute the solution while swirling. This creates a solution with a concentration of 4 U/0.1 mL. Patients will be seated and all usual precautions of sterility and skin preparation will be completed (i.e. alcohol wipes) Injections will be administered unilateral and/or bilaterally in accordance with the topography of the corresponding muscles (temporalis and masseter) into areas of maximal tenderness and pain. Plastic single use insulin syringes with 30 gauge needles will be used to inject 30 U intramuscularly into each masseter, divided evenly into 5 sites and 20 U will be injected into each temporalis, divided evenly over 5 sites. Injections will be completed by the principal investigator and supervisors who will be trained in botulinum toxin injections.
16010320|NCT02810002|Device|Experimental infantry boot - DEFINITE-REGULATOR|Training: infantry basic training in the experimental boots
16010321|NCT02810002|Device|Control infantry boot|Training: infantry basic training in the control boots
16010322|NCT02809989|Drug|Ovaleap®|"About 6-8 weeks of observation per patient from start of the stimulation therapy with Ovaleap® depending on the duration of the required stimulating therapy. Up to 10-11 months per patient for follow-up but only if in case of songraphically intact intrauterine pregnancy to determinate the Baby-Take-Home-Rate (live-births)."
16010323|NCT02809976|Drug|Ruxolitinib 1.5% Phosphate Cream|twice daily topical application of Ruxolitinib 1.5% Phosphate Cream beginning at baseline and ending at week 20
16010324|NCT02809963|Drug|Eplerenone|50 mg tablets, oral use.
16010325|NCT02809963|Drug|Placebo|50 mg tablets, oral use
16010326|NCT02809950|Other|oral carbohydrate beverage|oral carbohydrate beverage (12.8% carbohydrates, 50 kcal/100ml, 290 mOsm/kg, NO-NPO®, Daesang WelLife Co., Ltd., Korea) 400ml in the evening of the day before surgery and at 6 am on the day of surgery, respectively
16010327|NCT02809950|Other|control group|NPO from midnight of the day before surgery
16010328|NCT02809937|Drug|dexmedetomidine|low-dose dexmedetomidine infusion
16010329|NCT02809937|Drug|placebo|normal saline infusion
16010330|NCT02809924|Other|Simulation-based just-in-time training|Video and low fidelity simulation (Laerdal® Neonatal Intubation Trainer, Laerdal Medical, Toronto, Canada)
16010331|NCT02809924|Other|Video training|Video describing endotracheal intubation
16010332|NCT02809911|Device|Provant|
16010333|NCT02809898|Procedure|surgery or biopsy|Do radical surgery or biopsy to obtain a pathological result
16010334|NCT02809885|Biological|Hepatitis E serology|
16010335|NCT02809872|Other|Diagnostic Thoracic Ultrasound|
16010336|NCT02809859|Device|Fisher & Paykel Healthcare CPAP Device|Fisher & Paykel Healthcare CPAP Device
16010337|NCT02809846|Device|Quell|
16010338|NCT02809846|Device|Sham Quell|
16010339|NCT02809833|Drug|Tocilizumab|Tocilizumab must be selected by the treating physician in advance of the study and will be not provided by the Sponsor. The dose/regimen are at the discretion of the prescriber. However, tocilizumab in the SmPC is specified as 8 milligrams per kilogram (mg/kg) via intravenous (IV) infusion at 4-week intervals.
16010340|NCT02809820|Drug|Carvedilol|Patients randomized to this group will receive carvedilol at the highest dose tolerated
16010341|NCT02809820|Drug|Metoprolol|Patients randomized to this group will receive metoprolol at the highest dose tolerated
16010342|NCT02809807|Other|measurement of the work of breathing|We have been evaluating breathing patterns, index of respiratory efforts and blood gases in all randomized conditions. Airway pressure, inspiratory and expiratory flows have been measured. An esophageal catheter has been introduced at the beginning of the study to measure esophageal pressure (Peso) and calculate indexes of respiratory effort (PTPeso, WOB). SpO2 has been continuously measured and capillary blood bases were drawn at the end of each condition. Comfort has also been assessed. FreeO2 System has been used and pre-programmed in accordance with the patient SpO2 target zone for potential correction of the hypoxemia occurrences. Differences among randomized conditions are one without gas mask as for the baseline and two with gas masks but different canisters.
16010343|NCT02809807|Device|Gas Mask|Differences among randomized conditions are one without gas mask as for the baseline and two with gas masks but different canisters.
16010344|NCT02809794|Device|Fisher & Paykel Healthcare CPAP Device|Fisher & Paykel Healthcare CPAP Device
16010345|NCT02809781|Biological|Intravenous infusion of MSCs|Intravenous infusion of MSCs:Human bone marrow-derived MSCs 1.0E+6 MSC/kg, IV drop
16010346|NCT02809781|Drug|Etanercept|50mg,hypodermic injection,once per week, for 12 weeks
16010347|NCT02809768|Drug|Avatrombopag|
16010348|NCT02809768|Drug|Fluconazole|
16010349|NCT02809768|Drug|Itraconazole|
16010350|NCT02809768|Drug|Rifampin|
16010351|NCT02809755|Drug|4% Lidocaine|
16010352|NCT02809755|Other|Saline|
16010353|NCT02809742|Drug|Ropivacaine|Epidural : automatic intermittent boluses associated with patient controlled bolus using ropivacaine
16010354|NCT02809729|Drug|Cefazolin|2 g of cefazolin diluted in 0.9% saline by endovenous, once, at the moment of anesthetic induction
16010355|NCT02809729|Drug|sterile saline|0.9% saline sterile by endovenous, once, at the moment of anesthetic induction
16010356|NCT02809729|Procedure|oncologic breast surgery|The patient will be submitted to a conservative oncologic breast surgery
16010357|NCT02809729|Other|Microbiology|Samples for quantitative cultures will be obtained in the operating room before antisepsis and the end of surgery. A sample is also collected with the same patterning, on the first postoperative day, immediately after the removal of the dressing placed in the operating room. Will be passed in a standardized manner, a sterile swab soaked in saline over a standard 5cm by 10cm area determined by a field fenestrated sterile filter paper.
16010360|NCT02809703|Other|Survey Questions|Subjects will receive surveys via direct mail. They will be given the opportunity to opt in to receive a phone call regarding quality of life.
16010361|NCT02809690|Device|CAT|Undergo 18F-FMAU PET/CT
16010362|NCT02809690|Drug|18F-FMAU|Patients receive radiotracer F 18 d-FMAU IV over 1 minute and then undergo 18F-FMAU PET/CT
16010363|NCT02809690|Other|Laboratory Biomarker Analysis|Correlative studies
16010364|NCT02809690|Procedure|Multiparametric Magnetic Resonance Imaging|Undergo mpMRI
16010365|NCT02809690|Device|Positron Emission Tomography|Undergo 18F-FMAU PET/CT
16010366|NCT02809690|Device|Ultrasound|Undergo TRUS-guided biopsy
16010367|NCT02809677|Drug|Escitalopram|Escitalopram (ESC) for the Major Depressive Disorder (MDD). Dose titration schedule: begin at Week 1 at 5mg PO QD for 4 weeks. Increase to 10mg PO QD at Week 4 (if needed). Increase to 20mg PO QD at Week 8 (if needed).
16010368|NCT02809677|Drug|Venlafaxine XR|Venlafaxine Extended Release (VEN XR) for the Major Depressive Disorder (MDD). Dose titration schedule: begin at Week 1 at 75mg PO QD for 4 weeks. Increase at Week 4 to 150mg PO QD (if needed). Increase at Week 8 to 300mg PO QD (if needed).
16010369|NCT02809677|Drug|Bupropion XR|Bupropion Extended Release (BUP XR) for the Major Depressive Disorder (MDD). Dose titration schedule: begin at Week 1 at 150mg PO QD for 4 weeks. Increase at Week 4 to 300mg PO QD (if needed). Increase at Week 8 to 450mg PO QD (if needed).
16010370|NCT02809677|Drug|Sertraline|Sertraline (SERT) for the Major Depressive Disorder (MDD). Dose titration schedule: begin at Week 1 at 50mg PO QD for 4 weeks. Increase at Week 4 to 100mg PO QD (if needed). Increase at Week 8 to 200mg PO QD (if needed).
16010371|NCT02809677|Drug|Mirtazapine|Mirtazapine (MIRT) for the Major Depressive Disorder (MDD). Dose titration schedule: begin at Week 1 at 15mg PO qHS for 4 weeks. Increase at Week 4 to 30mg PO qHS (if needed). Increase at Week 8 to 45mg PO qHS (if needed).
16010372|NCT02809677|Drug|Buspirone|"Buspirone (BUSP) as an augmenting agent for the Major Depressive Disorder (MDD).
~Dose titration schedule: begin at Week 24 of the study (if needed) at 10mg PO QD for 3 days, then 10mg PO BID for 4 weeks. Increase at Week 28 (if needed) to 15mg PO BID. Increase at Week 32 (if needed) to 20mg PO BID."
16010373|NCT02809677|Drug|Quetiapine|"Quetiapine (QUET) as an augmenting agent for the Major Depressive Disorder (MDD).
~Dose titration schedule: begin at Week 24 of the study (if needed) at 25mg PO qHS for 4 weeks. Increase at Week 28 (if needed) to 50mg PO qHS. Increase at Week 32 (if needed) to 100mg PO qHS."
16010374|NCT02809677|Drug|Aripiprazole|Aripiprazole as an augmenting agent for the Major Depressive Disorder (MDD) for non-response patients at Week 48 of study. Dose titration schedule: begin at Week 48 (if needed) at 2mg PO QD for 4 weeks.
16010375|NCT02809677|Drug|Lithium|Lithium as an augmenting agent for the Major Depressive Disorder (MDD) for non-response patients at Week 48 of study. Dose titration schedule: begin at Week 48 (if needed) at 300mg PO qHS for 4 weeks.
16010376|NCT02809651|Device|Infrascanner|bilateral measurement cerebral blood flow with near infrared spectroscopy using the Infrascanner on the frontal, temporal, parietal and occipital region of the head.
16010377|NCT02809638|Other|ultrasound elastography|
16010378|NCT02809612|Behavioral|Internet-based platform|Internet-based platform with information and training modules based on acceptance and commitment therapy for vulvodynia patients
16010379|NCT02809599|Behavioral|DIZZTINCT|The intervention, DIZZTINCT, is a multi-faceted educational and care-process based intervention designed to improve the guideline-concordant care of patients with BPPV in the emergency department. The intervention includes six main components: the recruitment and training of local champions who will serve as colleague experts in the community; interactive hands-on educational sessions that address BPPV mechanisms, evidence and practice; a high-yield decision-aid web application for self study and point of care use; development of a referral network for follow up care; follow-up educational sessions to review successes and barriers amongst the intervention group; and other resources developed locally in partnership with the community medical providers.
16010380|NCT02809586|Behavioral|SMI + I|This 8-week social media based intervention consists of e-coaches delivering positive content to facilitate peer interaction. Participants will earn incentives for interaction during the intervention (8 weeks).
16010381|NCT02809586|Behavioral|SMI|This 8-week social media based intervention consists of e-coaches delivering positive content to facilitate peer interaction. This group will NOT receive incentives for their participation in the secret group.
16010382|NCT02809573|Drug|Chidamide|In the lead-in period, patients take a single dose of Chidamide tablet on the first day and then off for 3 days before the first cycle begins. In the subsequent treatment cycles, Chidamide tablets are given orally on Day 1,4,8 and 11 of each cycle.
16010383|NCT02809573|Drug|cyclophosphamide|On Day 1, cyclophosphamide is given in a 20-minute intravenous (IV) infusion at 750 mg/m^2 in 5 minutes after chidamide administration
16010384|NCT02809573|Drug|adriacin|On Day 1, Adriacin is given in a 20-minute IV infusion at 50 mg/m^2 soon after cyclophosphamide administration.
16010385|NCT02809573|Drug|vincristine|On Day 1, vincristine is given in IV infusion at 1.4 mg/m^2 after adriacin administration.
16010386|NCT02809573|Drug|prednisone|On Day 1 to 5, prednisone is given orally at 100 mg once a day
16010387|NCT02809560|Procedure|Induced sputum method using hypertonic serum|Collection of expectoration in sterile vial, conserved in ice all along the examination
16010388|NCT02809547|Device|Dried Blood Spot device|
16010389|NCT02809534|Drug|Anlotinib|Anlotinib p.o. qd
16010390|NCT02809521|Other|Activity Liking|
16010391|NCT02809508|Dietary Supplement|Oily fish|A selection of oily fish, including salmon, herring and mackerel, provided for dinner and lunch
16010392|NCT02809508|Dietary Supplement|Poultry|A selection of poultry, mainly chicken, provided for dinner and lunch
16010393|NCT02809495|Other|use of app in smartphone|
16010394|NCT02809482|Other|Eucaloric feeding|3 days of a diet designed to maintain energy balance
16010395|NCT02809482|Other|Overfeeding|3 days of a diet designed to induce a 40% positive energy balance
16010396|NCT02809469|Drug|apixaban dose reduction|Participants taking apixaban 5mg BID will have their dose reduced to 2.5mg BID, and those taking 2.5mg BID will have their dose reduced to 2.5mg once daily (in the morning).
16010397|NCT02809456|Drug|Nicorandil|oral intake
16010398|NCT02809443|Biological|GLS-5700|GLS-5700 contains a single plasmid containing DNA encoding for pre-membrane and envelope (prME) proteins of the Zika virus
16010399|NCT02809430|Device|Continuous Positive Airway Pressure|Auto-titrating Continuous Positive Airway Pressure (APAP) among patients admitted to a rehabilitation unit after ischemic or hemorrhagic stroke for 3 month treatment period.
16010400|NCT02809404|Drug|Everolimus|
16010401|NCT02809391|Device|Orthotics alone|The sole thin sport orthotic will be heat moulded to participants footwear. A top cover will be used of similar cushioning thickness and durometer properties as the orthotics+texture intervention.
16010402|NCT02809391|Device|Orthotics+textured top cover|The sole thin sport orthotic will be heat moulded to participants footwear. A textured material will be used as the orthotic top cover in this intervention.
16010403|NCT02809378|Drug|Palonosetron|newly developed 5-HT3 antagonists with long half life (48 hrs) intravenous administration prior to anesthesia induction
16010404|NCT02809378|Drug|sevoflurane|Inhalational anesthetics Halogenated.
16010405|NCT02809378|Drug|remifentanil|ultra-short acting opioid anesthetics
16010406|NCT02809378|Drug|pentothal sodium|intra-venous anesthetics for anesthesia induction
16010407|NCT02809378|Drug|propofol|intra-venous anesthetics for anesthesia induction and maintenance
16010408|NCT02809365|Device|FreeStyle Libre|Addition of FreeStyle Libre system for 10 weeks to the treatment of uncontrolled Type 2 diabetic patients currently on multiple daily injections
16010409|NCT02809365|Device|personal glucometer|Subjects in the Control Group will measure blood glucose levels by personal glucometer (SMBG = self monitoring blood glucose)
16010410|NCT02809352|Biological|Human papillomavirus genotyping|
16010411|NCT02809339|Other|Questionnaires|
16010412|NCT02809326|Behavioral|17 week Exposure Therapy Control Arm|15 individual VR-assisted exposure therapy sessions and 14 psychoeducational group sessions conducted over a period of 17 weeks. After the Education session, treatment occurs three times a week during the Virtual Reality (VR) assisted Exposure phase, and then once a week during the Psychoeducational phase.The psychoeducational group therapy, will include topics such as: DSM-IV criteria of PTSD, prevalence of PTSD, risk factors for PTSD, biological and conditioning models of PTSD, PTSD comorbidity, pharmacological treatment of PTSD, the impact of substance abuse, impairment in interpersonal functioning among veterans with PTSD, and issues related to anger control problems and suggested coping strategies
16010413|NCT02809326|Behavioral|Trauma Management Therapy|TMT consists of 29 treatment sessions administered over a period of 17 weeks. After the Education session, treatment occurs three times a week during the Virtual Reality (VR) assisted Exposure phase, and then once a week during Social and Emotional Regulation (SER). Education and exposure are implemented individually while SER is administered in small group sessions (3-5 people). All exposure treatment sessions will terminate after a decline of 50% in the highest rating recorded. SER sessions will be 90 minutes. The treatment program as a whole results in approximately 43.5 hours of therapist contact for each patient.
16010414|NCT02809326|Behavioral|Intensive 3-Week Trauma Management Therapy|Intensive 3-Week Trauma Management Therapy consists of 29 treatment sessions administered over a period of 3 weeks. Individual VR-assisted exposure sessions and group sessions are conducted Monday-Friday with individual sessions conducted in the morning and Social and Emotional Regulation (SER) sessions conducted in the afternoon. Education and exposure are implemented individually while SER is administered in small group sessions (3-5 people). All exposure treatment sessions will terminate after a decline of 50% in the highest rating recorded. SER sessions will be 90 minutes. The treatment program as a whole results in approximately 43.5 hours of therapist contact for each patient.
16010415|NCT02809313|Dietary Supplement|Treatment Gingivitis with Probiotic|gingivitis treatment (scaling and coronary polish) and one sachet containing Lactobacillus rhamnosus SP1 per day during 3 months
16010416|NCT02809313|Other|Treatment Gingivitis conventional|gingivitis treatment (scaling and coronary polish) and one sachet containing Placebo (talc powder) per day during 3 months
16010417|NCT02809300|Biological|blood collection|
16010418|NCT02809287|Procedure|Jackknife posture|patients with left lateral position plus jackknife position when perform laparoscopic hepatectomy
16010419|NCT02809274|Other|questionnaires|• Influence of iron parameters on Patient-reported symptoms as assessed by Myeloproliferative Neoplasm Symptom Assessment Form Total Symptom Score (MPN-SAF TSS) for assessment of the severity of symptoms, Quality of life evaluation by The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30) and fatigue assessment by PROMIS Fatigue Scale: Short Form
16010420|NCT02809261|Procedure|Ultrasound-guided perineural injection with 5% dextrose|Ultrasound-guided perineural injection with 5% dextrose (3cc) between proximal carpal tunnel and surrounding median nerve with hydrodissection.
16010421|NCT02809261|Procedure|Ultrasound-guided perineural injection with normal saline|Ultrasound-guided perineural injection with normal saline (3cc) between proximal carpal tunnel and surrounding median nerve with hydrodissection.
16010422|NCT02809261|Drug|Normal Saline|Normal saline is safe for perineural injection.
16010423|NCT02809261|Drug|5% Dextrose|5% Dextrose could decrease the release of CGRP and substance P to reduce the nerve inflamation.
16010424|NCT02809248|Device|ZES|stent implantation (zotarolimus eluting stent)
16010425|NCT02809248|Device|BMS|stent implantation (bare metal stent)
16010426|NCT02809235|Dietary Supplement|coconut oil|3 tablespoons per day of supplemental coconut oil
16010427|NCT02809222|Other|Samples|Blood samples
16010428|NCT02809222|Other|Quality of life questionnaire|Questionnaire to assess the quality of life of cancer patients
16010429|NCT02809196|Behavioral|1: Tailored SMS program implicating friend and mother|
16010430|NCT02809196|Behavioral|2: Standardized SMS program implicating friend and mother|
16010432|NCT02809196|Behavioral|4: Standardized SMS program implicating friend, not mother|
16010433|NCT02809196|Behavioral|5: Tailored SMS program implicating mother, not friend|
16010434|NCT02809196|Behavioral|6: Standardized SMS program implicating mother, not friend|
16010435|NCT02809196|Behavioral|7: Tailored SMS program not implicating mother or friend|
16010436|NCT02809196|Behavioral|8: Standardized SMS program not implicating mother or friend|
16010437|NCT02809196|Behavioral|9: No SMS program|
16010438|NCT02809183|Drug|Placebo|oral suspension
16010439|NCT02809183|Drug|TRC101|oral suspension
16010440|NCT02809170|Dietary Supplement|Arginine|Arginine is an amino acids
16010441|NCT02809170|Dietary Supplement|Citrulline|Citrulline is an amino acid
16010442|NCT02809144|Procedure|Nerve block|Nerve block: 31 ml ropivacaine 7.5 mg/ml (Lateral sagittal infraclavicular brachial plexus block) + 4 ml ropivacaine 5 mg/ml (suprascapular nerve block) + 5 ml ropivacaine 5 mg/ml (superficial cervical plexus block)
16010443|NCT02809131|Drug|polymixin/bacitracin|Antibacterial irrigation
16010444|NCT02809131|Drug|cephalexin, or levofloxacin, or clindamycin|Post operative oral antibiotics
16010445|NCT02809131|Drug|Saline|Saline irrigation
16010446|NCT02809118|Drug|AM-111 0.4 mg/ml|AM-111 0.4 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia
16010447|NCT02809118|Drug|AM-111 0.8 mg/ml|AM-111 0.8 mg/mL gel is administered with a single dose into the affected ear after topical anesthesia
16010448|NCT02809118|Other|Placebo|Placebo gel is administered with a single dose into the affected ear after topical anesthesia
16010449|NCT02809105|Drug|linaclotide|Oral administration once daily
16010450|NCT02809105|Drug|Placebo|Oral administration once daily
16010451|NCT02809092|Biological|NK Cells + Chemotherapy Starting|"Drug: G-CSF G-CSF daily by vein starting on Day -7 until post nadir of absolute neutrophil counts (ANC) are equal or over 1000.
~Other Names:
~Filgrastim Neupogen Drug: Fludarabine monophosphate 30 mg/m2 by vein on Days -6, -5, -4, -3, and -2.
~Other Names:
~Fludarabine Phosphate Fludara Drug: Cytarabine 2 g/m^2 by vein on Days -6, -5, -4, -3, and -2.
~Other Names:
~Ara-C Cytosar DepoCyt Cytosine arabinosine hydrochloride Procedure: Natural Killer (NK) Cell Infusion NK Cell infusion on Days 0 to 14 for 6 doses total according to dose escalation schema."
16010452|NCT02809079|Drug|Mycophenolate mofetil|Mycophenolate mofetil 500mg Bid
16010453|NCT02809079|Drug|Prednisone|prednisone 10mg Qd
16010454|NCT02809066|Other|Sufficient dietary calcium intake in premenstrual syndrome|"Intervention group was ensured to take at least 1000 mg calcium from foods, 700-800 mg of it from dairy and dairy products, according to Recommended Dietary Allowances (RDA), for two months. These foods were;
~50 gr kashkaval cheese,
~400 ml milk and
~150 gr yogurt for each day."
16010455|NCT02809053|Biological|SAIT101|Dose of 375mg/m2 body surface area (BSA) i.v. on Days 1, 8, 15, and 22
16010456|NCT02809053|Biological|MabThera®|Dose of 375mg/m2 body surface area (BSA) i.v. on Days 1, 8, 15, and 22
16010457|NCT02809040|Other|Electrocardiogram/Echocardiography|"Electrocardiogram (ECG) is a non-invasive (does not require an incision into the body) test that records the electrical activity of the heart.
~Echocardiography is a non-invasive scanning of heart images using standard two-dimensional, three-dimensional, and Doppler ultrasound to create images of the heart."
16010458|NCT02809040|Other|Portable digital auscultation|"Traditional Stethoscope :An acoustic medical device for auscultation, or listening to internal sounds of human body.
~Digital Stethoscope :Electronic stethoscope is a passive heart sound recording device. The heart sound listening and recording will be performed by trained personnel in a way very similar to that of using conventional cardiac auscultation"
16010459|NCT02809027|Drug|Ginger|
16010460|NCT02809027|Drug|Placebo|
16010461|NCT02809014|Other|Dentifrice F-Complex|Use of few of dentifrice on brushing for one week, twice day.
16010462|NCT02809014|Other|Dentifrice F-Complex + NaF|Use of few of dentifrice on brushing for one week, twice day.
16010463|NCT02809014|Other|Dentifrice standard|Use of few of dentifrice on brushing for one week, twice day. It's for the positive control of fluoride
16010464|NCT02809014|Other|Dentifrice with tara gum|Use of few of dentifrice on brushing for one week, twice day. It's for analysis of negative control of fluoride and action only of tara gum.
16010465|NCT02809001|Procedure|Fat grafting|In the experimental group, liposuction will be performed and autologous fat graft will be harvest after washing with saline. Patients will receive autologous fat graft transplantation subdermally to expanded skin.
16010466|NCT02808988|Procedure|periodontal phase 1 therapy|periodontal phase 1 therapy consisted of scaling and root planning with ultrasonic and hand instruments under local anesthesia and gingival crevicular fluid collection by the same investigator.
16010467|NCT02808988|Procedure|gingival crevicular fluid collection|gingival crevicular fluid collection by periopapers
16010468|NCT02808988|Other|zoledronic acid|5 mg/year zoledronic acid (i.v.)
16010469|NCT02808975|Drug|Placebo|Subcutaneous injections administered as described in arm description
16010470|NCT02808975|Drug|Adalimumab|Subcutaneous injections administered as described in arm description
16010471|NCT02808962|Procedure|Cooled RFA of sacral lateral branches|A single target will be identified at the junction of the sacral ala and S1 superior articular process, corresponding to the location of the L5 dorsal ramus. Then, utilizing a stainless steel Epsilon Ruler (Kimberly Clark, Irving, TX, USA), three targets will be localized 8-10 mm lateral to the S1 and S2 posterior sacral foramen at the 2:30, 4:00, and 5:30 positions. Two targets will be localized at the S3 level. Local infiltration with 1% lidocaine and minimal sedation with IV midazolam will be utilized. Once suitable sensory and motor stimulation are verified and impedance is acceptable, each target will be anesthetized with 1 mL of 1% lidocaine prior to each lesion being created at 60 degrees centigrade for 2 minutes and 30 seconds.
16010472|NCT02808949|Drug|Dapivirine|Participants will receive a silicone elastomer vaginal matrix ring containing 25 mg of dapivirine to wear for approximately 14 continuous days. Participants age 18 and over, at least 6 weeks postpartum, able to produce and express breast milk for 14 consecutive days.
16010473|NCT02808936|Procedure|Remote ischemic preconditioning|three cycles of ischemia (5 min) / reperfusion (5 min) of available upper or lower limb with an automated machine using blood pressure cuff
16010598|NCT02807987|Drug|CS-3150|CS-3150 1.25 to 2.5, 5mg, orally
16010599|NCT02807974|Drug|CS-3150|CS-3150 1.25 to 2.5, 5mg, orally
16010474|NCT02808936|Procedure|Sham control|The patients had the same pneumatic cuff around the upper arm and similar maneuvers were performed, but pressure was not applied to the cuff.
16010475|NCT02808923|Other|Foam Rolling|"Participants will perform unilateral hamstring rolling for 2 repetitions of 1 minute with 15 second rest breaks on each leg with a 6x 36 foam roller."
16010476|NCT02808923|Other|Static Stretching|Participants will perform supine static hamstring stretch on a wall for 2 repetitions of 1 minute with 15 second rest breaks on each leg. When the position no longer causes a moderate stretching sensation to the hamstring, subjects will move their bodies closer to the wall to intensify the stretch.
16010477|NCT02808910|Behavioral|Nudged to eat less added salt and more other seasonings|
16010478|NCT02808910|Behavioral|Nudged to avoid foods high in salt content, and to choose foods low in salt content|
16010479|NCT02808910|Behavioral|Nudged to eat more vegetables|
16010480|NCT02808910|Behavioral|Nudged to eat smaller portions|
16010481|NCT02808910|Behavioral|Nudged to eat less calorie-dense food|
16010482|NCT02808897|Device|Standard drainage|One (1) chest tube must be placed in the anterior mediastinum. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 French (FR) to 32 FR shall be used for the single anterior mediastinal chest tube.
16010483|NCT02808897|Device|Active Clearance Technology drainage|One (1) PleuraFlow chest tube must be placed in the anterior mediastinum with one (1) standard chest tube. The other chest tube(s) may be placed at the discretion of the operator. Chest tubes with internal diameter 28 FR to 32 FR shall be used for the single anterior mediastinal chest tube.
16010484|NCT02808884|Genetic|Circulating tumor DNA assay|Blood samples will be separated into plasma and cellular fraction including erythrocytes and buffy coat.The plasma fraction will be placed in a separate tube and frozen for subsequent analysis. Frozen plasma samples, de-identified, will be delivered to Pathway Genomics where DNA content will be analyzed with a circulating tumor DNA assay employing the UBC/Boreal Genomics enrichment technology. All of the participants' plasma will be sent to Pathway, where it will be used up in the assay. Circulating tumor DNA assay results (raw sequencing data) from Pathway Genomics will be returned to UBC and analyzed for the presence of cancer mutations. Any samples showing activating mutations above the assay's technical Limit of Detection (LOD) will be called positive. One exception will be made for TP53 mutations that are known to exist in some normal individuals at low levels. For these mutations, a level of 0.1% will be set, above which the sample will be called positive.
16010485|NCT02808871|Drug|Pirfenidone|Pirfenidone three times daily (2403 mg) for 52 weeks
16010486|NCT02808871|Drug|Placebo|Placebo three times daily for 52 weeks
16010487|NCT02808845|Other|microalbuminuria|
16010488|NCT02808832|Behavioral|Educational materials|5-minute video and information sheet with a list of suggested questions to ask the provider
16010489|NCT02808819|Biological|Benralizumab|Benralizumab administered subcutaneously every 4 weeks
16010490|NCT02808819|Biological|Benralizumab|Benralizumab administered subcutaneously every 8 weeks
16010491|NCT02808806|Other|real-time audio-visual feedback|real-time audio-visual feedback to caregivers on TSD (i.e. displaying time, a colour code which will provide an easy-view visualization on whether or not pre-set median time delays between locations are exceeded, and auditory signals indicating the elapsed time), displayed through handhelds and on pre-mounted tablets through the whole trajectory of acute stroke care
16010492|NCT02808793|Drug|AK002|
16010493|NCT02808767|Drug|Prasugrel|Prasugrel 60 mg loading dose and 10mg/5mg once daily maintenance dose
16010494|NCT02808767|Drug|Ticagrelor|Ticagrelor 180 mg loading dose and 90 mg twice daily maintenance dose
16010495|NCT02808754|Procedure|Remote Ischemic Preconditioning|Those randomized to RIPC will undergo a standard protocol of 4 cycles of 5 minutes of forearm ischemia with 5 minutes of reperfusion requiring 35 minutes for an application. Forearm ischemia will be induced by a blood pressure cuff inflated to 200mmHg or at least 15mmHg higher than the systolic pressure if systolic > 185mmHg or until the radial pulse is obliterated. This can occur during anesthesia induction and incision/dissection prior to manipulation or clamping of the carotid.
16010496|NCT02808741|Drug|F901318 SDD|Pharmacokinetics area under curve
16010497|NCT02808741|Drug|F901318 IR|Pharmacokinetics area under curve
16010498|NCT02808741|Drug|F901318 IR Fasting|Pharmacokinetics area under curve
16010499|NCT02808741|Drug|F901318 IR Fed|Pharmacokinetics area under curve
16010500|NCT02808728|Drug|Pain Cocktail with Exparel|pain cocktail: bupivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 80cc preparation as well as an injection of Exparel (bupivacaine liposome injectable suspension), 20cc of 1.3% Exparel, to total 100cc.
16010501|NCT02808728|Drug|Pain Cocktail with Ropivacaine|pain cocktail: ropivacaine, ketorolac, morphine, and epinephrine mixed with saline into a 100cc preparation.
16010502|NCT02808715|Other|Blood Sample Collection|Blood draw #1 Site of blood draw: IMU Volume of blood: 20mL Purpose of blood draw: Isolation of genomic DNA Site of storage: NHRIS biobank Coding: Specimens will be identified using a research ID that will be affixed to samples using bar-coding. After the blood is collected, stored the blood at 4 degree Celsius and contact the NHCS biobank coordinator to collect the blood samples. The blood samples must be collected within 1 hour of collection.
16010503|NCT02808702|Behavioral|Cognitive-behavioral therapy|Twelve weekly sessions of individual cognitive-behavioral therapy
16010504|NCT02808689|Behavioral|Lifestyle Factors|Will look at nutrition and exercise that influence long-term health and chronic diseases.
16010505|NCT02808689|Other|Customized use of Dietary Supplements|Reduce ongoing biologic imbalances from deficiencies in dietary oxidants/ antioxidants via vitamin supplementation. Approach is customized based on results for laboratory testing.
16010506|NCT02808689|Other|Currently Accepted Asthma Care Guidelines|Use of asthma care guidelines set forth by the National Institutes of Health/National Heart, Lung and Blood Institute (NIH/NHLBI) and Global Initiative for Asthma
16010507|NCT02808676|Dietary Supplement|Vitamin D3|Dose: 10000 IU, three times per week, orally.
16010547|NCT02808377|Other|Surgical Pelvic Organ Pessary|In participants randomized to intervention, the SPOP will be placed at the completion of surgery, following routine placement of IDC and prior to placement of vaginal pack. The SPOP is available in 4 sizes and the surgeon will select the appropriate size so that the SPOP rests snugly without undue tension inside the hymeneal remnant. The SPOP is sutured in place with 2/0 Vicryl to prevent dislodgement at the level of the hymen.
16010508|NCT02808676|Other|Exercises (E)|All participants will complete three (3) group training sessions per week (total 20 weeks), under the supervision of trainers. Each exercise session will last approximately 60 minutes and will happen after the cognitive training/control (CT cCT) session. The exercise session will be a combined aerobic and progressive strengthening exercise. Within each small group of four to eight individuals, participants follow the program tailored to their individual functioning level, with constant monitoring by the trainers. Participants are expected to attend all training sessions and research staff will strongly encourage them to do so.
16010509|NCT02808676|Other|Cognitive Training (CT)|CT intervention will involve computer-based multimodal and multi-domain dual-task training with memory load. A custom-written program, developed for neuro-rehabilitation and used in previous research trials for cognitive and mobility outcomes will be used. Training sessions will take place in groups of four to eight participants before each of the fitness-training session for duration of 30 min max. Participants will perform a concurrent visuo-motor task (dual-task combination) composed of different sets of visual stimuli that have to be identified by tapping designated figures on an digital tablet (IOS or Android system). Participants will perform discrimination tasks involving sets of items (e.g. letters, numbers, animals, vehicles, fruits, celestial bodies).
16010510|NCT02808676|Other|placebo D3|matching placebo for Vitamin D3
16010511|NCT02808676|Other|control cognitive training|As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 30 min computer skills training.
16010512|NCT02808676|Other|Placebo exercise|As a control activity to ensure the same time exposure as in the interventions arms, participant in the control arm will receive a 60 min of a tone exercise regimen
16010513|NCT02808663|Biological|fecal calprotectin concentration|
16010514|NCT02808663|Biological|blood collection|
16010515|NCT02808650|Other|Laboratory Biomarker Analysis|Correlative studies
16010516|NCT02808650|Other|Pharmacological Study|Correlative studies
16010517|NCT02808650|Drug|Prexasertib|Given IV
16010518|NCT02808637|Other|Manual Pressure|First, the infants were seated on their mothers' knees. Next, 10-second manual pressure was applied on the vaccine injection site. Then DTaP/IPV/Hib was administered in accordance with the conventional injection technique.
16010519|NCT02808637|Other|Rapid Injection without Aspiration|First, the infants were seated on their mothers' knees. Then DTaP/IPV/Hib was administered by using rapid injection without aspiration technique.
16010520|NCT02808637|Other|Manual Pressure + Rapid Injection without Aspiration|First, the infants were seated on their mothers' knees. Next, 10-second manual pressure was applied on the vaccine injection site. Then DTaP/IPV/Hib was administered by using the rapid injection without aspiration technique.
16010521|NCT02808637|Other|Control|First, the infants were seated on their mothers' knees. Then DTaP/IPV/Hib was administered by using the conventional injection technique.
16010522|NCT02808624|Drug|L-CARNOSINE|L-CARNOSINE is a supplement given with chemotherapy to prevent peripheral neuropathy.
16010523|NCT02808611|Drug|propranolol|Reduction of the ANS response
16010524|NCT02808611|Drug|Placebo|
16010525|NCT02808598|Behavioral|Breast Cancer Clinical Trials Education Program|The purpose of this study is to test a program designed to increase African American and Hispanic American women's scientific literacy, knowledge of clinical trials, and to facilitate breast cancer clinical trial participation.
16010526|NCT02808585|Drug|PB1046 Injection|Four weekly subcutaneous injections of PB1046.
16010527|NCT02808585|Drug|Placebo Injection|Four weekly subcutaneous injections of placebo.
16010528|NCT02808572|Biological|Plasma osteoprotegerin level|dosage of plasma osteoprotegerin
16010529|NCT02808572|Biological|Plasma fibroblast growth factor 23 level|dosage of plasma fibroblast growth factor 23
16010530|NCT02808572|Procedure|Vascular calcification score|measurement of vascular calcification score by multidetection computerized tomography
16010531|NCT02808559|Device|Bodystudio ATBM (Automatic Total Body Mapping)|The mapping of the entire body is automatically done using a high-resolution apparatus (20 photographs of the patient in 8 positions (face, back, lateral left and right, specific extremities) The photographs will be done with a standardized procedure established by FotoFinder. Every lesion is completely evaluated and the PASI score can be calculated.
16010532|NCT02808533|Drug|Topiramate|Topiramate capsules starting with 25 mg b.i.d with an incremental increase of 25 mg b.i.d weekly upto a maximum of 100 mg b.i.d.
16010533|NCT02808533|Other|Placebo|Placebo capsules visually identical to those containing topiramate will be administered.
16010534|NCT02808507|Other|Active TB case finding|Active TB case finding (ACF) refers to any number of strategies used to identify individuals with active TB disease, outside of passive case finding. In passive case finding, individuals with symptoms present at health centers for diagnosis. In active case finding, the health system makes an effort to identify TB cases before they present passively.
16010535|NCT02808468|Behavioral|Brief Cognitive Therapy|Cognitive strategies to help achieve balanced thinking around sexual assault and alcohol use
16010536|NCT02808455|Drug|Pacritinib 400 mg Capsule (Treatment A)|Four 100-mg capsules of pacritinib administered as a single oral dose
16010537|NCT02808455|Drug|Pacritinib 80 mg Solution (Treatment B)|A single 80-mg oral solution dose of pacritinib
16010538|NCT02808442|Biological|UCART19|
16010539|NCT02808429|Drug|Placebo|Participants received placebo matched to Atacicept once weekly as subcutaneous (SC) injection during this study up to a maximum of 72.1 weeks.
16010540|NCT02808429|Drug|Atacicept 25 mg|Participants received 25 milligrams (mg) of Atacicept once weekly as SC injection during this study up to a maximum of 73.6 weeks.
16010541|NCT02808429|Drug|Atacicept 75 mg|Participants received 75 mg of Atacicept once weekly as SC injection during this study up to a maximum of 74.1 weeks.
16010542|NCT02808416|Biological|Personalized cellular vaccine|"Cancer patients with brain metastases will undergo tumor resection or biopsy, and receive tumor antigen mRNA pulsed cellular vaccines.
~Other Names:
~• Tumor antigen pulsed DC and PBMC, autologous tumor vaccine"
16010543|NCT02808403|Other|No intervention|No intervention; observation of routine medical care
16010544|NCT02808390|Drug|GED-0507-34-Levo 80 mg|GED-0507-34-Levo 80 mg BID for 8 Weeks
16010545|NCT02808390|Drug|GED-0507-34-Levo 160 mg|GED-0507-34-Levo 160 mg BID for 8 Weeks
16010546|NCT02808390|Drug|Placebo|Placebo BID for 8 Weeks
16010548|NCT02808364|Biological|Personalized cellular vaccine|Patients with recurrent glioblastoma will undergo tumor resection and receive tumor antigen pulsed cellular vaccines.
16010549|NCT02808351|Drug|Berberine|
16010550|NCT02808338|Device|Philips BiPAP AutoSV Advanced System One|Auto SV Auto Servo Ventilation is a mode of positive airway pressure used to treat obstructive and complex central sleep apnea. This devices is FDA approved and will be set according to a predetermined setting.
16010551|NCT02808338|Device|Modified Philips BiPAP ASV|This Modified BiPAP ASV will be set to a predetermined setting. This is the investigational device.
16010552|NCT02808338|Device|ResMed S7 VPAP Adapt|This device is FDA approved and will be set to predetermined setting.
16010553|NCT02808338|Device|ResMed S9 VPAP Adapt|This device is FDA approved and will be set to predetermined setting.
16010554|NCT02808325|Drug|Gelaspan 4%|Gelaspan 4% combined with Sterofundin ISO
16010555|NCT02808325|Drug|Gelofusine 4%|Gelofusine 4% combined with Sodium Chloride
16010556|NCT02808312|Drug|Cilofexor|Tablet(s) administered orally in a fed state on Day 1
16010557|NCT02808299|Other|HBV infection history|HBV infection history or HBV carriers
16010558|NCT02808286|Behavioral|Hybrid|The hybrid emotion-focused treatment integrates procedures from exposure and dialectical behavior therapy (DBT) with a clear uniting conceptualization focused on targeting underlying processes that maintain co-occurring chronic pain and emotional problems.
16010559|NCT02808286|Behavioral|internet Cognitive Behavior Therapy (iCBT)|A state-of-the-art CBT pain treatment, delivered via the internet.
16010560|NCT02808273|Drug|Bemiparine|Bemiparine 3500 UI as antithrombotic according to a protocol for prevention of postoperative deep venous thrombosis
16010561|NCT02808247|Drug|Nintedanib|Pharmaceutical form: Soft gelatine capsule Pharmaceutical code: Nintedanib (BIBF1120) Source: Boehringer Ingelheim Pharma GmbH & Co. KG Unit strength: 100 mg and 150 mg capsules Daily dose: 400 mg (200 mg twice daily p.o.) Route of administration: oral
16010562|NCT02808247|Drug|Ifosfamide|Ifosfamide will be given at a dose of 3 g/m2 intravenously on days 1, 2 and 3 every 21 days. The total dose per cycle is 9 g/m2
16010563|NCT02808234|Procedure|One or two level lumbar interbody fusion surgery|One or two level lumbar interbody fusion surgery with allograft derived from human amnion and amniotic fluid.
16010564|NCT02808234|Other|Nucel|Allograft derived from human amnion and amniotic fluid
16010565|NCT02808208|Biological|Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC)|A single topical application of mesenchymal stem cells derived from own fat biopsy to the surface of the outflow vein (right next to the fistula) over a five-minute period.
16010566|NCT02808208|Drug|Placebo|5-mL of Lactated Ringers solution topical application to the surface of the outflow vein (right next to the fistula) over a five-minute period.
16010567|NCT02808208|Biological|Two Applications of Adipose Derived Mesenchymal Stem Cells (AMSC)|Two topical applications of mesenchymal stem cells derived from own fat biopsy to the surface of the outflow vein (right next to the fistula) over a five-minute period at stage one and two of fistula surgery
16010568|NCT02808195|Other|Constraint-induced therapy|
16010569|NCT02808195|Other|kinect-based constraint-induced therapy|
16010570|NCT02808182|Drug|Nicotinic acid|oral administration of nicotinic acid (100mg at 0, 30, 60, 90, 120, 180, 240 and 300 min) to minimize WAT intracellular lipolysis
16010571|NCT02808182|Other|[7,7,8,8-2H]-palmitate|using i.v. administration of [7,7,8,8-2H]-palmitate (in 25% human albumin) from time -60 to +360 min
16010572|NCT02808182|Other|[U-13C]-palmitate|oral administration of [U-13C]-palmitate (0.2 g mixed into the liquid meal) at time 0 min
16010573|NCT02808182|Procedure|Biopsy|A subcutaneous abdominal 0.5-g adipose tissue biopsy will be performed at the end of protocols A0 and A1
16010574|NCT02808182|Other|liquid meal|At time 0, a standard liquid meal (400 mL, 906 kcal, 33g-fat/34g-protein/101g-carbohydrates i.e. 33%/17%/50% calories) will be drunk over 20 minutes
16010575|NCT02808156|Other|unilateral upper limbs intensive training|The unimanual intensive training group focuses on the training of the more affected arm and restraint the less affected arm.
16010576|NCT02808156|Other|bilateral upper limbs intensive training|The bimanual intensive training focuses activities that required the use of both hands.
16010577|NCT02808143|Biological|BCG Solution|Given intravesically
16010578|NCT02808143|Other|Laboratory Biomarker Analysis|Correlative studies
16010579|NCT02808143|Biological|Pembrolizumab|Given intravesically
16010580|NCT02808143|Other|Pharmacological Study|Correlative studies
16010581|NCT02808130|Other|hyperlipidemia, periodontitis, gingivitis|GCF samples were collected using periopaper strips. Prior to sample collection, each site was gently air-dried, all supragingival plaque was removed, and the area was carefully isolated to prevent samples from being contaminated by saliva
16010582|NCT02808117|Dietary Supplement|MNP|"Program that delivered MNP and implemented by an MFI in Haiti during 2011-2012.
~One form of micronutrient supplementation proven to effectively combat micronutrient deficiency."
16010583|NCT02808104|Drug|mazindol|
16010584|NCT02808091|Drug|GIFOX-Bortezomib|GIFOX-Bortezomib will be given every 21 days for 4 cycles
16010585|NCT02808091|Drug|GIFOX-Bortezomib|GIFOX-Bortezomib will be given every 21 days for a total of 6 cycles.
16010586|NCT02808091|Radiation|IMRT|a minimum of 50 Gy of IMRT to tumor bed and neck (5 weeks)
16010587|NCT02808078|Device|Gait training with augmented reality|20 sessions (30 min. duration) over 4 weeks of gait training with augmented reality.
16010588|NCT02808078|Device|Standard training|20 sessions (30 min. duration) over 4 weeks of gait training without augmented reality.
16010589|NCT02808065|Drug|Tacrolimus|Administered dose were individualized according to their own prescription
16010590|NCT02808065|Drug|Mycophenolate mofetil|Administered dose were individualized according to their own prescription
16010591|NCT02808052|Drug|Minocin (minocycline) for Injection|200mg IV Minocin given over 1 hour
16010592|NCT02808039|Other|Platelet reactivity testing|assessment of platelet aggregation using the VerifyNow purinergic receptor P2Y, G-protein coupled, 12 (P2Y12) platelet function assay (Accumetrics, San Diego, California)
16010593|NCT02808026|Drug|CS-3150|CS-3150 2.5 to 5mg, orally, once daily after breakfast
16010594|NCT02808013|Drug|NDS-446|
16010595|NCT02808013|Drug|Placebo|
16010596|NCT02808000|Device|BIP Foley (latex) or BIP Foley -silicone|
16010600|NCT02807961|Drug|ELX-02|Synthetic aminoglycoside
16010601|NCT02807961|Drug|Placebo|Placebo comparator
16010602|NCT02807948|Device|Pacemaker, ICD, or CRT device|MRI Scans on SJM device implanted subjects for clinical purpose
16010603|NCT02807935|Device|Optical coherence tomography imaging|
16010604|NCT02807922|Drug|Zopiclone|
16010605|NCT02807922|Drug|Placebo|
16010606|NCT02807909|Drug|BMS-986177|
16010607|NCT02807909|Drug|Itraconazole|
16010608|NCT02807909|Drug|Diltiazem ER|
16010609|NCT02807883|Drug|Blinatumomab|Participants receive Blinatumomab as continuous intravenous infusion at a dose of 28 µg/24 hours over 4 weeks followed by a treatment-free period of 2 weeks, defined as one 6-week treatment cycle. In the first induction cycle, the initial dose of Blinatumomab is 9 µg/day for the first 7 days of treatment which then will be escalated (dose step) to 28 µg/day starting on day 8 (week 2) through day 29 (week 4). For all subsequent cycles, 28 µg/day is the dose for all 4 weeks of continuous treatment. Participants receive 4 cycles of blinatumomab at 3, 6, 9, and 12 months following hematopoietic cell transplantation (HCT).
16010610|NCT02807883|Procedure|Hematopoietic Cell Transplantation|Hematopoietic progenitor cell infusion
16010611|NCT02807870|Drug|Methylphenidate|Methylphenidate treatment with a initial dosage of 0,3 mg/kg per day (weekly dosage adjustments).
16010612|NCT02807870|Behavioral|Parental training|Weekly parental training conducted by behavioral psychologists.
16010613|NCT02807870|Other|Psychoeducational groups for parents|Weekly psychoeducational groups conducted by educators.
16010614|NCT02807870|Drug|Placebo pill|Placebo pill during 8 weeks.
16010615|NCT02807857|Procedure|Standard care|Patients will receive the treatment that their primary care physician has decided to prescribe for their disease
16010616|NCT02807844|Drug|MCS110|MCS110 and PDR001 - for administration once every 3 weeks via i.v. infusion.
16010617|NCT02807844|Drug|PDR001|MCS110 and PDR001 - for administration once every 3 weeks via i.v. infusion.
16010618|NCT02807831|Behavioral|Executive functions training|Daily training of executive functions via activities to develop auto-regulation, attention and memory.
16010619|NCT02807831|Behavioral|Language skills training|Daily training of language skills via activities to develop phonological awareness and vocabulary.
16010620|NCT02807831|Other|Regular school curriculum|Ministry of Education national school curriculum.
16010621|NCT02807818|Behavioral|Home visiting Program for Young Pregnant Women|
16010622|NCT02807805|Drug|Abiraterone Acetate|Given PO
16010623|NCT02807805|Drug|Niclosamide|Given PO
16010624|NCT02807805|Drug|Prednisone|Given PO
16010625|NCT02807792|Device|Perianal access device|Perianal access device
16010626|NCT02807779|Drug|Dexamethasone infusion|Patients will receive dexamethasone infusion following plain balloon angioplasty
16010627|NCT02807779|Device|Drug coated balloon|Patients will receive angioplasty with a drug-coated balloon following plain balloon angioplasty
16010628|NCT02807766|Behavioral|Behavior modification|Each group has 30 subjects and experiences six months' training.
16010629|NCT02807766|Behavioral|Behavior modification and sensory integration training|Each group has 30 subjects and experiences six months' training.
16010630|NCT02807766|Behavioral|Behavior modification and applied behavioral analysis|Each group has 30 subjects and experiences six months' training.
16010631|NCT02807766|Behavioral|Behavior modification and TEACCH|Each group has 30 subjects and experiences six months' training.
16010632|NCT02807753|Other|Ankle and Knee Ultrasound Joint Assessment|Ultrasound Examination of the ankles and knees
16010633|NCT02807753|Other|Ankle and Knee Magnetic Resonance Imaging|Ankle and Knee Magnetic Resonance Imaging
16010634|NCT02807740|Other|Virtual reality|Each session will consist of multiple exercises. These ones are already described, each exercise will be performed by the patient for 4 minutes followed by a 1 minute of rest.
16010635|NCT02807740|Other|Conventional rehabilitation program|In each C rehabilitation session, patients underwent 3 phases: 1) Warm-up phase: passive mobilization of main joints and muscular strengthen of lower limbs; 2) Active phase (both standing than seated): exercises of motor coordination with upper and lower limbs, balance training, start and stop exercises, deambulation training; 3) cool-down phase (with seated patient): manipulation exercises, mobilization exercises, respiratory exercises.
16010636|NCT02807727|Drug|Intralipid 20%|Single intravenous bolus dose of 1.5 ml/kg over 3 minutes
16010637|NCT02807727|Drug|Modified Ringers Lactate|Single intravenous bolus dose of 1.5 ml/kg over 3 minutes
16010638|NCT02807701|Procedure|Laparoscopic pancreaticoduodenectomy|"Laparoscopic pancreaticoduodenectomy
~dissection
~reconstruction"
16010639|NCT02807701|Procedure|Open pancreaticoduodenectomy|Open pancreaticoduodenectomy
16010640|NCT02807688|Behavioral|Health Promotion Intervention|"The intervention package consists of the following elements:
~i. educational sessions on the importance of diet and fitness; ii. motivational interviews to maintain participants in the program, to discuss participants' physical conditions, habits and opinions as to diet and fitness; iii. monitoring the participation in the program and health behaviour, specifically for diet and fitness, and adherence to the intervention on diet and fitness; iv. regular physical exercise under the guide and supervision of an expert trainer."
16010641|NCT02807675|Drug|CVT-301, LIP|All subjects will receive 1 dose of CVT-301 and 1 dose of placebo inhalation powder, to be taken concomitantly with their standard oral medication in 2 dosing periods. The order of treatment will be randomized, with subjects assigned to 1 of 2 sequences CVT-301 (A) administered first, followed by placebo (B), or the reverse order (BA)
16010642|NCT02807675|Other|Placebo|All subjects will receive 1 dose of CVT-301 and 1 dose of placebo inhalation powder, to be taken concomitantly with their standard oral medication in 2 dosing periods. The order of treatment will be randomized, with subjects assigned to 1 of 2 sequences CVT-301 (A) administered first, followed by placebo (B), or the reverse order (BA)
16010643|NCT02807662|Behavioral|Adapted Seeking Safety Intervention|Intervention participants received Seeking Safety psychosocial education Intervention adapted for prenatal care setting.
16010644|NCT02807649|Dietary Supplement|Experimental: Nutrilite® Low dose|Two tablets consume daily with meal.
16010645|NCT02807649|Dietary Supplement|Experimental: Nutrilite® High dose|Two tablets consume daily with meal.
16010646|NCT02807649|Dietary Supplement|Placebo Comparator: Placebo|Two tablets consume daily with meal.
16010652|NCT02807623|Drug|Ibuprofen|The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
16010653|NCT02807623|Behavioral|Compound Exercise of Push-ups|The participants will perform an exercise intervention of push-ups as immediately as possible but no more than 15 minutes after influenza vaccine receipt. The number of pushups performed will be at least 80% of the participants last Army Physical Fitness Test (APFT) score in one session. The number of pushups will be recorded. A baseline lactate fingerstick blood specimen will be collected with either the serology sample (if possible) or from the hand opposite the vaccine receipt arm prior to performing pushups and a second finger stick sample within 3-8 minutes, but no more than 15 minutes after vaccine receipt.
16010654|NCT02807623|Drug|oral placebo|The participants will take their first dose of the study drug immediately after influenza vaccine receipt. The medication will be blinded and dispensed by a research pharmacist. The participants will receive instructions on the dosing, frequency and a recommendation to take with food or milk and will be provided a snack with their first dose.
16010655|NCT02807610|Drug|Inj Etomidate|Induction of anesthesia using IV Etomidate 0.3mg kg-1 as a single dose in patients undergoing day care procedure, after premedication with IV midazolam 0'.2mg kg-1 and IV Fentanyl 2ug kg-1.
16010656|NCT02807610|Drug|Injection Propofol|Induction of anesthesia using IV Propofol 2mg kg-1 as a single dose in patients undergoing day care procedure, after premedication with IV midazolam 0.2mg kg-1 and IV Fentanyl 2ug kg-1
16010657|NCT02807610|Drug|Placebo for Propofol|After premedication with IV midazolam 0.2mg/kg and IV Fentanyl 2ug/kg Placebo was given.
16010658|NCT02807597|Drug|LS301|-LS301 is a small molecule consisting of a NIR fluorescent dye and an octapeptide that is cyclized through a disulfide bond.
16010659|NCT02807597|Device|Cancer Vision Goggles|-Member of operating team will wear during surgery
16010660|NCT02807597|Procedure|Surgery|-Standard of care
16010661|NCT02807584|Device|ELECT|
16010662|NCT02807571|Procedure|Wide Awake Local Anesthesia No Tourniquet|Wide Awake Local Anesthesia No Tourniquet for office based hand surgery.
16010663|NCT02807558|Drug|SY-1425 (tamibarotene)|Continuous days 1-28 of a 28-day cycle of SY-1425 at 6 mg/m2/day orally divided into twice a day dosing.
16010664|NCT02807558|Drug|azacitidine|75 mg/m2/day IV or SC days 1-7 of a 28 day cycle in combination with SY-1425.
16010665|NCT02807558|Drug|Daratumumab|16 mg/kg/day IV starting on Cycle 1 Day 1 weekly for 8 weeks, followed by dosing every two weeks for 16 weeks, followed by dosing every 4 weeks in combination with SY-1425.
16010666|NCT02807545|Behavioral|Scoliosis Specific Exercises|
16010667|NCT02807532|Other|atrial fibrillation|In the case-control trial, patients with atrial fibrillation 7 days after surgery will be assigned to an atrial fibrillation group.
16010668|NCT02807532|Other|non-atrial fibrillation|In the case-control trial, patients without atrial fibrillation 7 days after surgery will be assigned to a non-atrial fibrillation group.
16010669|NCT02807519|Genetic|collection of salivary cytokines|Collection of the saliva will be done following this procedure: The collection will be done prior to any other dental manipulation. The test person is sitting with its head tilted slightly forward. Initially, any saliva present in the mouth must be swallowed or spit out completely. Then, a paraffin gum is given to the test person. This paraffin gum must be chewed for minimally 2 and maximally up to 5 minutes. During the time period that the test person is chewing the paraffin gum, the saliva must be spitted into a cup repeatedly, or the saliva can also be let run passively into the cup. The amount of saliva is then weighted (1g equivalent to 1 ml) and a saliva flow rate (ml/min) is calculated and noted.
16010670|NCT02807506|Device|Mobile Service Robot|The goal is to build a low-cost mobile service robot with an arm that will focus on the simple, but key, repetitive, data-driven tasks that robots do well. Rather than attempt to create a robot helper that mimics humans, the goal is to free human caregivers from the time-consuming tasks that robots can accomplish with facility, thereby allowing humans to focus on tasks that humans do best (i.e. human contact).
16010671|NCT02807493|Device|Occlusal Support Device|Bite plate
16010672|NCT02807493|Other|Control|Control group
16010673|NCT02807480|Behavioral|Exposure-based therapy|Exposure-based therapy
16010674|NCT02807480|Behavioral|Behavioral Activation therapy|Behavioral Activation therapy
16010675|NCT02807480|Behavioral|Computer-based behavioral assessment|Computer-based tasks during which participants respond to images on the screen, including abstract images, emotional faces, and pleasant and unpleasant images.
16010676|NCT02807480|Behavioral|Surveys and Interviews|Surveys and interviews in which participants will be asked to answer questions related to their mental and physical health history and current symptoms.
16010677|NCT02807480|Device|Magnetic resonance imaging (MRI)|Magnetic resonance imaging (MRI) will be used to obtain information concerning the structure of the brain, as well as to assess changes associated with blood flow in the brain while participants are completing behavioral tasks (see description of computer-based behavioral assessment intervention).
16010768|NCT02806791|Drug|FILGRASTIM|
16010678|NCT02807480|Device|Electroencephalography (EEG)|Electroencephalography (EEG) will be used to assess changes in the electrical activity of the brain while participants are completing behavioral tasks (see description of computer-based behavioral assessment intervention).
16010679|NCT02807467|Drug|Dexmedetomidine|Continuous infusion of dexmedetomidine between 8pm and 6am after diagnosis of hyperactive or mixed delirium. The infusion might have to be repeated several times to achieve resolution of delirium.
16010680|NCT02807467|Drug|Propofol|Continuous infusion of propofol between 8pm and 6am after diagnosis of hyperactive or mixed delirium. The infusion might have to be repeated several times to achieve resolution of delirium.
16010681|NCT02807454|Drug|Daratumumab|
16010682|NCT02807454|Drug|Durvalumab|
16010683|NCT02807454|Drug|Pomalidomide|
16010684|NCT02807454|Drug|Dexamethasone|
16010685|NCT02807441|Drug|Acetylsalicylic acid|Patients will receive different doses of aspirin perioperatively to assess bleeding association.
16010686|NCT02807428|Drug|AYX1 Injection 660 mg/6 mL|6 mL solution for intrathecal injection with 660 mg of AYX1 (Brivoligide)
16010687|NCT02807428|Drug|Placebo Injection 6 mL|6 mL solution for intrathecal injection; vehicle formulation designed to mimic AYX1 Injection (with no active drug)
16010688|NCT02807415|Drug|Lumacaftor plus Ivacaftor|Oral treatment with lumacaftor/ivacaftor tablets according to the prescribing information
16010689|NCT02807389|Drug|MSC Fistula Plug|Eligible patients will be treated with a fistula plug that has been coated with autologous mesenchymal stromal cell.
16010690|NCT02807376|Device|Surgeon's 'standard of care' stapler|
16010691|NCT02807376|Device|Ethicon Powered Vascular Stapler|
16010692|NCT02807363|Drug|Leuprolide Oral Tablet 4-mg QD|4-mg oral tablet once daily for 28 consecutive days.
16010693|NCT02807363|Drug|Leuprolide Oral Tablet 4-mg BID|4-mg oral tablet twice daily for 28 consecutive days.
16010694|NCT02807363|Drug|Leuprolide Depot|3.75 mg intramuscular depot injection
16010695|NCT02807363|Drug|Leuprolide Oral Tablet 10-mg BID|10-mg oral tablet twice daily for 28 consecutive days.
16010698|NCT02807337|Drug|Caphosol|
16010699|NCT02807337|Drug|0,9% NaCl|
16010700|NCT02807324|Other|Venapunction|The only invasive procedure is a venapunction where 75 ml blood will be extracted. The only unfavourable side effect can be a small hematoma (rare).
16010701|NCT02807298|Drug|4%articaine|intraligamentary injections of 0.9 ml of 4%articaine and 1:100,000 epinephrine
16010702|NCT02807298|Drug|2% Lignocaine|Intraligamentary injections of 1.8 ml of lidocaine and 1:100,000 epinephrine
16010703|NCT02807298|Drug|Epinephrine|Intraligamentary injections of 1.8 ml of lidocaine and 1:100,000 epinephrine
16010704|NCT02807285|Drug|Ocrelizumab|Participants will receive 600 mg ocrelizumab as two 300 mg infusions separated by 14 days, every 24 weeks.
16010705|NCT02807272|Drug|Tipifarnib|Oral tablet
16010706|NCT02807259|Behavioral|Multi-level intervention|At the individual level, the intervention will focus on: (i) structured reflection groups for FSWs to enhance self-esteem, encourage critical reflection around gender norms and violence, and build individual and collective efficacy; (ii) separate sessions for intimate partners to discuss issues around violence and condom use as well as gender, equity, respect and responsibility; (iii) skills building around female condoms (iv) access to individual and couples-based counselling. At the community level, the intervention will focus on: (i) strengthening the supportive crisis management systems so that they are able to address 'domestic' as well as 'work-place' violence among FSWs and (ii) building an environment that encourages action against violence from intimate partners by training male champions and developing folk media troops to generate discussion around gender, masculinity, violence and HIV risk behaviours.
16010707|NCT02807246|Biological|Maflor®, Mamsel Pharmaceuticals, Turkey|"Dietary Supplement: Probiotics probiotics at a dose of 1x109 CFU/day. (Maflor®, Lactobacillus rhamnosus GG 109 CFU, Mamsel Pharmaceuticals, Turkey)
~Other Name: Maflor®"
16010708|NCT02807246|Other|drops of saline|Dietary Supplement: Breast milk +drops of saline
16010709|NCT02807220|Drug|Imuneks 10mg|Two capsules of the study drug every morning approximately two hours after breakfast for six weeks
16010710|NCT02807207|Drug|A: 400 mg pacritinib|Treatment A
16010711|NCT02807207|Other|B: Placebo|Treatment B
16010712|NCT02807207|Drug|C: 400 mg moxifloxacin|Treatment C
16010713|NCT02807194|Other|spinal anesthesia|
16010714|NCT02807194|Other|general anesthesia|
16010715|NCT02807194|Procedure|lumbar disc herniation|
16010716|NCT02807181|Drug|Cisplatin-gemcitabine|Systemic chemotherapy
16010717|NCT02807181|Device|Radiation: SIRT + chemotherapy (cisplatin-gemcitabine)|SIR-Spheres microspheres followed by systemic chemotherapy
16010718|NCT02807168|Other|NT-proBNP (Cardiac Biomarkers)|
16010719|NCT02807155|Behavioral|Transition Empowerment Program|Participants will receive the 1-year transition empowerment program/curriculum (TEP-CG) alone.
16010720|NCT02807155|Behavioral|Transition Empowerment Program (TEP) + Diabetes Wellness Council (DWC)|Participants will receive the identical 1-year Transition Empowerment Program, plus the innovative wellness-based group process (council).
16010721|NCT02807155|Behavioral|Online Transition Empowement Program Access|Participants assigned to an outside medical home would be followed according to the clinical needs as assessed by their medical provider. They would be given access to the TEP website curriculum, but would not participate in other aspects of the 1-year TEP.
16010722|NCT02807142|Biological|NC 1 cell therapy|All patients will be treated with NC1
16010723|NCT02807129|Biological|blood withdrawn|
16010724|NCT02807129|Biological|urine collection|
16010725|NCT02807116|Drug|Pacritinib|Subjects received a single oral 400-mg dose of pacritinib
16010726|NCT02807116|Drug|Rifampin|Subjects received 600-mg oral doses of rifampin; administered QD following a 7-day washout period
16010727|NCT02807116|Drug|Pacritinib and Rifampin|On Day 17, a single oral 400-mg dose of pacritinib was co-administered with the final 600-mg dose of rifampin.
16010728|NCT02807103|Drug|Rituximab|1 g intravenous pulse at day1 and day15
16010729|NCT02807103|Drug|Placebo-rituximab|intravenous pulses at day1 and day15
16010730|NCT02807103|Drug|Cyclophosphamide|intravenous 9 pulses : 600 mg/m2 at days 1, 15 and 29, and then 500 mg-fixed dose at days 50, 71, 92, 113, 134 and 155.
16010731|NCT02807103|Drug|Placebo-cyclophosphamide|intravenous 7 pulses : at days 29, 50, 71, 92, 113, 134 and 155.
16010732|NCT02807090|Other|Lumbar Stabilization Exercise|There will be 16 sessions, twice a week, with 40-60 minutes each session. In this arm the participants will learn basic notions about anatomy and biomechanics and the lumbar stabilization technique. They will be evaluated by a pressure biofeedback in the first day that will be used in the training. The lumbar stabilization technique consists of three stages: cognitive, associated and automatic. The biofeedback is used in the first stage and it helps patients to do the best contraction of stabilization muscles in different levels of pressure. Then, in stage two the patients do the contraction without the use of biofeedback and in the last phase different exercises are associated with the contraction of stabilization muscles.
16010733|NCT02807090|Other|Circular dance|There will be 16 sessions, twice a week, with 60 minutes each session. In this arm the participants will do the exercises in a group of 20 subjects. In every meeting there will be the follow stages: reception, reflection, warming/stretching, explanation about circular dance, choreography orientation, practice and finishing.
16010734|NCT02807077|Drug|Pacritinib|Group 1, 2, 3, and 5 will be administered single oral 400-mg dose of pacritinib. Subjects in the Group 4 received a single 400-mg dose of pacritinib during two different treatment periods: Dialysis and Inter-Dialysis
16010735|NCT02807064|Drug|Bifidobacteria|0.5 ml per os all days for 2 months
16010736|NCT02807064|Drug|placebo|0,5 ml per os all days for 2 months
16010737|NCT02807051|Drug|Pacritinib|Single 400-mg dose (four 100-mg capsules) administered in the morning on Days 1 and 12
16010738|NCT02807051|Drug|Clarithromycin|Twice-daily, 500-mg dose (one 500-mg tablet) administered every 8 to 12 hours on Day 8 through the morning of Day 12
16010739|NCT02807051|Drug|Pacritinib and Clarithromycin|On Day 12, a single oral 400-mg dose of pacritinib was co-administered with the final 500-mg dose of clarithromycin
16010740|NCT02807038|Procedure|Lung function test|Pregnant woman use the individual passive sampler 15 days before the spirometry test at each trimester
16010741|NCT02807012|Other|Nursing educational intervention|"The nursing educational intervention by home visits will consist in three home visits by nurses until 14, 21 and 30 days after discharge to the intervention group. The nurses will give verbal information to family caregiver related to the care of elderly with stroke based on protocol with orientation related: information about stroke; emotional support; how to access health services; nutrition; airway; hygiene; positioning and transferring; prevent falls; dress/undress; medications; physiological eliminations; skin care. Furthermore, nurses will give some printed materials that contain orientations related to the care.
~The control group could have ou not the usual care guidelines provide by health services that have access."
16010742|NCT02806999|Drug|Berberine; Insulin|Participants will receive 500mg Berberine twice a day for 8 days; Meanwhile，participants will also continue to receive intensive insulin therapy.
16010743|NCT02806999|Drug|Insulin|Participants will continue to receive intensive insulin therapy; Meanwhile, Participants will also receive a placebo twice a day for 8 days.
16010744|NCT02806986|Biological|IGSC 20%|Weekly administration of IGSC 20% via intravenous infusion
16010745|NCT02806973|Drug|Nasal Glucagon|Administered intranasally.
16010746|NCT02806960|Drug|Nasal Glucagon|Administered intranasally.
16010747|NCT02806947|Drug|Sirolimus|Sirolimus will be administered with a starting dose of 6 mg for patients older than 12 years, or 5 mg/m^2 for patients ≤ 12 years. Trough levels will be routinely measured and sirolimus will be kept at maintenance dosing for target therapeutic levels for minimum duration through Day 56 post-randomization.
16010748|NCT02806947|Drug|Prednisone|Prednisone will be administered at 2mg/kg/day x 3 days, and then tapered according to individual treating clinician judgment.
16010749|NCT02806934|Procedure|biological and ultrasound test|biological and ultrasound test 20 days after implantation in order to see the implantation rate
16010750|NCT02806921|Device|ZenLens|The ZenLens™ semi-scleral lenses are manufactured by Alden Optic Laboratories Inc., Lancaster, NY. They will be made in Boston XO material.
16010751|NCT02806908|Drug|JZP-110|
16010752|NCT02806908|Drug|Placebo|
16010753|NCT02806895|Drug|JZP-110|
16010754|NCT02806895|Drug|Placebo|
16010755|NCT02806882|Drug|Ceftaroline fosamil|600mg IV infusion
16010756|NCT02806869|Drug|Single dose of ibuprofen (800 mg tablet)|
16010757|NCT02806869|Dietary Supplement|Pulmocare, two 8.0 oz (236.6 mL) cans|
16010758|NCT02806856|Device|tDCS neuroConn|Cathodal on M1
16010759|NCT02806856|Device|Sham stimulation|Sham
16010760|NCT02806843|Device|Rehab InterCap system and 3D Kinect|The therapist will conduct a therapy session which will consist of various activities of daily living. During the session, the motion of the therapist and patients will be collected with a custom motion capture system (Rehab InterCap) and 3D visual mapping may take place using the Kinect device, audio will be recorded, and basic measurements of length (i.e. the distance from a participant's shoulder to elbow) will be taken. Patients and therapists will wear the sensors to capture their arm movements. 3D video motion capture may be completed with some subjects. This will involve subjects wearing reflective markers on their upper arms in addition to the intercap sensors.
16010761|NCT02806830|Drug|Optive|Optive eye drops will be prescribed to each included patients after their second intravitreal injection; patients will received 1 drop in the affected eye 2 times a day during 3 days
16010762|NCT02806817|Drug|ME-344|ME-344 is a synthetic small molecule mitochondrial inhibitor based on the isoflavan ring structure. ME-344 is a chiral compound, and is manufactured predominantly as a single stereoisomer that is dextrorotatory. As a stereoisomeric drug with two chiral centers, ME-344 is one of four potential stereoisomers. The current manufacturing process produces a racemic mixture of two of those stereoisomers, which are enantiomers, and ME-344 is separated from the levorotatory enantiomer by chromatography in the final step.
16010763|NCT02806817|Drug|Bevacizumab|Bevacizumab is a recombinant humanized monoclonal antibody that blocks angiogenesis by inhibiting vascular endothelial growth factor A (VEGF-A)
16010764|NCT02806817|Other|Normal saline|Use saline as placebo
16010765|NCT02806804|Biological|one dose test vaccine|
16010766|NCT02806804|Biological|one dose commercially available trivalent influenza vaccine|
16010767|NCT02806804|Biological|One dose of Quadrivalent Influenza Virus Vaccine|
16010769|NCT02806778|Other|BIS Monitor-guided sedation|The patients enrolled in the study will undergo BIS Monitor-guided sedation. Standard BIS Monitor will be used for the procedure to monitor the depth of sedation.
16010770|NCT02806778|Other|Jugular bulb catheter|Jugular bulb catheter will be implanted in the patients enrolled in the study.
16010771|NCT02806765|Dietary Supplement|(1S,3Z)-3-[(2E)-2-[(1R,3aS,7aR)-7a-methyl-1-[(2R)-6-methylheptan-2-yl]-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexan-1-ol|25 micrograms of (1S,3Z)-3-[(2E)-2-[(1R,3aS,7aR)-7a-methyl-1-[(2R)-6-methylheptan-2-yl]-2,3,3a,5,6,7-hexahydro-1H-inden-4-ylidene]ethylidene]-4-methylidenecyclohexan-1-ol every day for 6 months
16010772|NCT02806765|Other|Control|Placebo in Softgel form
16010773|NCT02806752|Drug|Triamcinolone Acetonide|Intravitreal inject 0.5mg of Ranibizumab and 2mg of Triamcinolone Acetonide.
16010774|NCT02806752|Drug|Ranibizumab|Intravitreal inject 0.5mg of Ranibizumab.
16010775|NCT02806739|Dietary Supplement|Soy Group (Soy Protein + Isoflavones)|Women in the intervention group are asked to eat a combination of soy foods that contain about 25 grams of protein and 60-75 milligrams of isoflavones per day, from the 16th gestational week to birth. A registered dietitian will instruct them to incorporate the soy foods into their daily diet.
16010776|NCT02806739|Dietary Supplement|Control Group (Minimize Soy Intake)|Women in the control group will be instructed by the dietitian how to avoid soy supplements and minimize soy intake.
16010777|NCT02806726|Device|iDesign 1.3-PRESBY treatment|Software used to calculate the LASIK treatment profile including a presbyopic correction component for the iDesign Advanced Wavescan Studio™ System within the Star S4 IR™ Excimer Laser System.
16010778|NCT02806726|Device|iDesign 1.3 treatment|Software used to calculate the LASIK treatment profile for the iDesign Advanced Wavescan Studio™ System within the Star S4 IR™ Excimer Laser System.
16010779|NCT02806713|Drug|Phenazopyridine|
16010780|NCT02806713|Other|no Phenazopyridine|Because the obvious effects on the urine coloration of pyridium no placebo or dummy are provided
16010781|NCT02806700|Behavioral|Twitter Diabetes Intervention|This group will be asked to use twitter for heart health ( e.g. tweeting, following, receiving tweets)
16010784|NCT02806674|Device|The eradication times of the patients|The patients who have failed more than 2 eradication courses with standardized treatment were the refractory infection of H. pylori group,and patients who succeeded at the first standardized treatment were the successful treatment group
16010785|NCT02806674|Device|The result of 13C-urea breath test after treatment|The intervention focused on the results from the result of 13C-urea breath test after treatment.The two groups were treatment based on the antibiotic susceptibility testing. Eight weeks after treatment,a 13C-urea breath test was performed on patients.The successful treatment group were patients with negative in 13C-urea breath tests in the first treatment. The refractory infection of H. pylori group were treatment failure patients after the second standardized treatment.
16010786|NCT02806661|Procedure|Vagus nerve-preserving Robot-assisted Gastrectomy|
16010787|NCT02806661|Procedure|Conventional Robot-assisted Gastrectomy|
16010788|NCT02806648|Drug|Palbociclib|Palbociclib
16010789|NCT02806635|Behavioral|OurRelationship|
16010790|NCT02806635|Behavioral|PREP Online|
16010791|NCT02806609|Other|Cold water immersion, with 10 degrees, for 10 minutes|cold water immersion
16010792|NCT02806609|Other|immersion in water at room temperature|immersion in water at room temperature
16010793|NCT02806609|Other|active recovery - running|active recovery
16010794|NCT02806609|Other|rest in the chair|rest in the chair
16010795|NCT02806596|Drug|Sevoflurane|After at least 4 minutes of stable inspired sevoflurane concentration, that concentration will be titrated to obtain a targeted bispectral index (BIS) level required for perform laryngoscopy. This level was initially set at 40, based on a preliminary study showing that such level of BIS was obtained at the laryngoscopy after common general anesthesia induction. For the next patients, BIS target was set according to a sequential allocation method (up and down).
16010796|NCT02806583|Other|structured support groups|Telephone-based Support Groups, information booklet and telephone-based preparatory meeting prior to the telephone-based support groups
16010797|NCT02806570|Device|Mitral valve repair|
16010798|NCT02806557|Device|Home finger-prick capillary blood count monitoring|A nurse will visit the participant's home according to the test schedule (up to a maximum frequency of 21 visits in a 21-day cycle) and perform the finger-prick capillary blood test and measure the neutrophil count using the Hemocue® WBC DIFF device.
16010799|NCT02806544|Drug|Tamoxifen|Tamoxifen 20mg by mouth daily
16010800|NCT02806531|Biological|two doses enterovirus 71 vaccine|Two doses of enterovirus 71 vaccine will be given in children aged 6-35 months old, 28 days interval.
16010801|NCT02806518|Procedure|DIRT|An infrared camera is used to capture video sequences of thermal images before, during and after exposure of the lower abdomen to a cold challenge.
16010802|NCT02806505|Drug|Peginterferon alfa-2a|Chronic Hepatitis C participants with end-stage renal disease undergoing hemodialysis will receive Peginterferon alfa-2a either 135 or 90 mcg SC once weekly up to Week 48.
16010882|NCT02805946|Drug|posaconazole|iv versus oral
16010883|NCT02805920|Drug|Bupivacaine|comparison of different volumes-dosages of 0.25% Bupivacaine
16010884|NCT02805907|Drug|Calcifediol|
16010885|NCT02805907|Drug|Placebo|
16010886|NCT02805894|Drug|NBTXR3 activated by IMRT only|Single local administration of NBTXR3 by injection into the prostate gland prior to the IMRT treatment
16010889|NCT02805868|Procedure|Bone Marrow Aspiration and Biopsy|Undergo bone marrow aspiration and biopsy
16010803|NCT02806492|Other|50-100ug phenylephrine before CPB|In this intervention we will administer 50-100 μg phenylephrine to the patient before CPB is started. This intervention will take place when the patient shows hypotension (MAP <60mmHg, according to protocol22). Because of the increase in PVR there will be a baroreceptor-reflex-mediated decrease in CO. On-line, we will quantify the percentage decrease in systemic blood flow (i.e. CO) by using the Modelflow algoritm incorporated in a non-invasive beat-to-beat finger blood pressure monitor. This will allow us to obtain a reference for the decrease in CO to use in the next interventions. Our hypothesis is that CO will decrease because of the baroreceptor-reflex. During this intervention NIRS and TCD MCA will be recorded.
16010804|NCT02806492|Other|50-100ug phenylephrine during CPB|In this intervention we will induce only 1 component of the changes at intervention (1), being the increase in MAP of approximately 20 mmHg by administrating 50-100 μg phenylephrine. The CPB enables us to maintain a constant CO and thus eliminating the baroreceptor-reflex. During this intervention NIRS and TCD MCA will be recorded.
16010805|NCT02806492|Other|decreasing CPB flow|With this intervention we will only create a change in CO, which enables us to eliminate the effect of blood pressure. We will modify CPB flow to achieve the CO decrease (in %) measured at intervention (1) meaning: pre-CPB after the bolus of 50-100 μg phenylephrine. In the case of unexpected increase (in %) of CO measured at intervention (1), we will still decrease CPB flow so we will be able to analyse decrease as well as increase in CPB flow. During this intervention NIRS and TCD MCA will be recorded.
16010806|NCT02806492|Other|Decreasing CPB flow AND 50-100ug phenylephrine|In this intervention we will simulate the 'normal' physiological state when administering phenylephrine. We will modify CPB flow to achieve the percentage change CO as observed during intervention (1) as well as administrate 50-100 μg phenylephrine. We expect to see similar outcomes as in intervention (1). During this intervention NIRS and TCD MCA will be recorded.
16010807|NCT02806492|Other|Increasing CPB flow|In this last intervention we will create an increase in MAP without using phenylephrine but only by increasing CO. This enables us to eliminate a possible direct α1-adrenergic effect on the cerebral vasculature. MAP will be raised approximately 20 mmHg by increasing CPB flow 20%. During this intervention NIRS and TCD MCA will be recorded.
16010808|NCT02806479|Other|Observational: Arrhythmogenic Substrate|
16010809|NCT02806466|Procedure|Fiberoptic bronchoscopy|
16010810|NCT02806453|Dietary Supplement|thickened formula|
16010811|NCT02806453|Dietary Supplement|Mg alginate|
16010812|NCT02806453|Behavioral|reassurance with lifestyle changes|
16010813|NCT02806440|Drug|Low dose naltrexone|Active comparator
16010814|NCT02806440|Drug|Placebo|Placebo comparator
16010815|NCT02806427|Other|Enteral Formula|
16010816|NCT02806414|Drug|Ivermectin|
16010817|NCT02806401|Device|landmark|
16010818|NCT02806401|Device|US_Ax|
16010819|NCT02806375|Procedure|Allogeneic hematopoietic stem cell transplantation|Day 0: Infusion of unmanipulated graft
16010820|NCT02806375|Drug|Busulfan|Days -5 through -3: Busulfan 1 mg/kg po qid №10
16010821|NCT02806375|Drug|Fludarabine monophosphate|Days -7 through -2: 30 mg/m2/day iv qd x 6 days
16010822|NCT02806375|Drug|Cyclophosphamide|Day +3 and +4: 50 mg/kg/day iv qd
16010823|NCT02806375|Drug|Ruxolitinib|Days -8 through -2 15 mg tid
16010824|NCT02806375|Drug|Ruxolitinib|Days +5 through +100: 7.5 mg bid
16010825|NCT02806362|Drug|Ombitasvir/paritaprevir/ritonavir|Tablet
16010826|NCT02806349|Dietary Supplement|American Ginseng|herb
16010827|NCT02806349|Dietary Supplement|Konjac-glucomannan fiber blend|Blend of 2 viscous fibers: konjac mannan and xanthan
16010828|NCT02806349|Dietary Supplement|Control|Fiber matched control for intervention (corn starch and wheat bran)
16010829|NCT02806336|Behavioral|Multi Modal Balance Training|Group balance class, obstacle course, strengthening exercises
16010830|NCT02806336|Behavioral|Weight Loss|Nutritional counseling to achieve 500 kcal standard hypocaloric diet
16010831|NCT02806323|Other|Yoga practice|
16010832|NCT02806310|Other|Blood draw|blood sampling for biomarker levels
16010833|NCT02806297|Procedure|Early cholecystectomy with IOC|The intervention will be laparoscopic cholecystectomy with intraoperative cholangiogram (IOC) on admission within 24 hours of presentation regardless of whether pain or tenderness are present or laboratory values are elevated.
16010834|NCT02806297|Procedure|Late cholecystectomy with IOC|The control will be laparoscopic cholecystectomy with IOC once the patient has met the following criteria: (a) a score of less than 2 on the Visual Analogue Pain Scale, (b) no tenderness on physical exam, and (c) decreased lipase to either less than half of the peak value or within normal range (73-393 U/L).
16010835|NCT02806284|Biological|PPSV23, Act-HIB|"described in Arm description"
16010836|NCT02806271|Behavioral|Worry Postponement|"In worry postponement, participants are instructed to learn to notice naturally occurring episodes of worry. When they notice they are worrying they are instructed to disengage from their worry and postpone it to a designated 30 minute worry period to be carried out at the same time and place daily during the two week intervention. Participants are to use their worry time to worry about problems that have come up during the day and to problem solve where appropriate."
16010837|NCT02806271|Behavioral|Worry Monitoring|For two weeks participants are instructed to monitor their worry using a smartphone based application. Participants are instructed to make a record each time they have a worry episode by briefly describing the content of their worry. Participants also complete two brief daily questionnaires about the duration of their worry, the intensity of their worry, their ability to disengage from their worry, and the occurrence of nighttime episodes of worry.
16010838|NCT02806258|Radiation|Accelerated partial breast irradiation|To date, there is no report on external beam APBI associated with CT in the neoadjuvant setting.In the NeoAPBI 01 trial, the objective is to demonstrate the efficacy of combined APBI and CT administered sequentially in patients with intermediate ad high risk BC. The hypothesis is that combined PST-sequential APBI may increase the rate of pCR, breast conservation and survival without additional toxicity, as seen with WBI.
16010839|NCT02806258|Drug|Chemotherapy|minimum of six cycles of PST using anthracycline and/or taxane based regimens
16010887|NCT02805894|Drug|NBTXR3 activated by Brachytherapy & IMRT|Single local administration of NBTXR3 by injection into the prostate gland prior to the Brachytherapy & IMRT treatment
16010888|NCT02805881|Device|Neurolief system|Non-invasive cephalic neurostimulation device
16071167|NCT02374567|Drug|Rivastigmine|
16010840|NCT02806245|Other|Biventricular pacing|"Randomization into one of 3 study arms for acute phase and for extended phase.
~Measurement of baseline variables on arrival to CCU. Acute pacing protocol (order of pacing randomized):
~Atrial sensing- right ventricular pacing 10 min.
~5 min no pacing (washout).
~Atrial sensing - biventricular pacing 10 min.
~5 min no pacing (washout).
~Intrinsic rhythm
~5 min no pacing (washout). Start extended phase pacing according to randomization. Measure hemodynamic variables 10 min after start of pacing.
~Measure hemodynamic variables 30 min after start of pacing. Pacing hiatus for 60 minutes at 24 hours with measurement of hemodynamics without pacing and after reinitiating pacing.
~Stop pacing at 72 hours or after extubation, whichever comes first. For those patients who are extubated before 72 hours: measurements will be taken before extubation and one hour after extubation. Pacing will then be stopped."
16010841|NCT02806232|Drug|Biltricide (racemate praziquantel) oral tablets|Biltricide (600 mg tablet) was administered to participants at a dose of 20 mg/kg in Part 1, Cohort 1 and at a dose of 40mg/kg in Part 1, Cohort 2.
16010842|NCT02806232|Drug|Racemate Praziquantel ODT|Racemate Praziquantel (PZQ) (150) mg was administered at a dose of 40 mg/kg in Part 1, Cohort 3 and at a dose of 60 mg/kg in Part 1, Cohort 4.
16010843|NCT02806232|Drug|Levo Praziquantel ODT|Levo PZQ (150 mg) was administered at a dose of 30 mg/kg in Part 1 Cohort 5, 45 mg/kg Part 1 Cohort 6, 60 mg/kg Part 1 Cohort 7, 50 mg/kg Part 2 Cohort 8, and 50 mg/kg Part 2 Cohort 9.
16010844|NCT02806219|Device|Prefilled syringe (PFS)|Active substance: Certolizumab Pegol Pharmaceutical form: Solution for injection Administration: By prefilled syringe (PFS)
16010845|NCT02806219|Device|e-Device|Active substance: Certolizumab Pegol Pharmaceutical form: Solution for injection Administration: By e-Device
16010846|NCT02806206|Drug|Prucalopride|A single 2 mg oral dose of prucalopride will be given to each study participant just before the ingestion of the capsule endoscopy pill.
16010847|NCT02806206|Drug|Placebo|A single dose of a placebo pill will be given to each study participant just before the ingestion of the capsule endoscopy pill.
16010848|NCT02806193|Procedure|Cardiovascular Magnetic Resonance Imaging|"Cardiac magnetic resonance imaging (CMR) has emerged as both a remarkably powerful diagnostic and prognostic tool for the assessment of cardiovascular disease. The high spatial resolution of CMR and the ability to characterize soft tissue provides the opportunity for unique diagnostic assessment of a myriad of cardiac pathology, including ischemic heart disease (IHD), preoperative assessment, intra- cardiac mass and thrombus, pericardial disease, valvular heart disease, and cardiomyopathy evaluation.
~Between individual CMR programs, GCMR will offer information useful in assessing the differences in protocol, performance, and clinical adaptation by varying geographic regions, institutional environments, and expertise. Such an assessment is critical for uncovering possible reasons for disparities in performance and obtaining opportunities for advancement."
16010849|NCT02806180|Procedure|Dual Operator Ultrasound Guided IV placement|Second operator holds ultrasound probe.
16010850|NCT02806180|Procedure|Single Operator Ultrasound Guided IV placement|Single operator holds ultrasound probe and places IV.
16010851|NCT02806167|Other|Clinical algorithm|Patients presenting with suspected acute CES will be assessed in accordance with the algorithm previously outlined.
16010852|NCT02806154|Other|DEXA|The appendicular muscle mass measured by DEXA
16010853|NCT02806141|Drug|Aerosolized plus intravenous colistin|Aerosolized colistin at the dose of 4 mg colistin base activity (CBA)/kg twice daily (8 mg/kg/day) plus intravenous colistin at a dose of 3.5 mg CBA/kg/dose twice daily (7 mg/kg/day)
16010854|NCT02806141|Drug|Intravenous colistin|Intravenous colistin at a dose of 3.5 mg CBA/kg/dose twice daily (7 mg/kg/day)
16010855|NCT02806128|Drug|Human Urinary Kallidinogenase for Injection|Patients need to complete laboratory tests within a specified time and to complete the experimental requirements of medication time
16010856|NCT02806115|Procedure|acetic acid-enhanced endoscopy|Acetic acid-enhanced endoscopy combines conventional endoscopy with the instillation of acetic acid.
16010857|NCT02806115|Drug|Acetic Acid|The concentration of acetic acid used in this study is 1.5%.
16010858|NCT02806115|Device|endoscope|This study using an EG-29-i10 endoscope (Pentax, Tokyo, Japan) and an EPK-i7010 processor (Pentax, Tokyo, Japan).
16010859|NCT02806102|Procedure|Percutaneous coronary intervention|Percutaneous coronary intervention
16010860|NCT02806102|Drug|Dual-antiplatelet therapy|Dual AntiPlatelet Therapy
16010861|NCT02806102|Procedure|Percutaneous coronary intervention|Percutaneous coronary intervention
16010862|NCT02806102|Drug|Dual-antiplatelet therapy|Dual AntiPlatelet Therapy
16010863|NCT02806089|Device|Handheld dynamometer|Evaluation of muscle strength
16010864|NCT02806089|Biological|Creatinine index|Evaluation of muscle mass using plasma creatinine level
16010865|NCT02806089|Device|Electrical bioimpedance analysis|Evaluation of lean body mass
16010866|NCT02806089|Other|"Voorrips score questionnaire"|Evaluation of physical activity
16010867|NCT02806089|Biological|Inflammatory and nutritional status|Evaluation of C reactive protein and albumin
16010868|NCT02806076|Procedure|No-touch RFA arm|No-touch RFA arm indicates RFA procedure without direct tumor puncture. In this study, RFA is done by using dual cooled electrode.
16010869|NCT02806076|Procedure|Conventional tumor puncture RFA arm|"Conventional tumor puncture RFA arm indicates RFA procedure using conventional tumor puncture technique. In this study, RFA is done by using dual cooled electrode."
16010870|NCT02806063|Procedure|intraoperative samples|
16010871|NCT02806050|Drug|Palbociclib|all patients will be treated with palbociclib, on a 3 weeks on, 1 week off cycle until progression
16010872|NCT02806050|Device|FES PET|all patients will have a FES PET at baseline
16010873|NCT02806050|Drug|Letrozole|all patients will be treated with Letrozole daily until progression
16010874|NCT02806024|Drug|Tranexamic Acid|
16010875|NCT02806024|Drug|Placebo Drug|50 cc Normal Saline IV
16010876|NCT02805998|Behavioral|Web-based CBT-I|
16010877|NCT02805998|Other|Treatment as Usual|
16010878|NCT02805985|Device|FLXfit™ TLIF Interbody Fusion Device|The FLXfit™ is an expandable, articulated interbody fusion device (IBFD) used in conjunction with supplemental fixation to provide structural stability in skeletally mature individuals following total or partial discectomy.
16010879|NCT02805972|Drug|Naloxone|4 mg / 0.1 ml
16010880|NCT02805972|Drug|Placebo|0.1 ml
16010881|NCT02805959|Device|MTS2|
16010890|NCT02805868|Other|Laboratory Biomarker Analysis|Correlative studies
16010891|NCT02805868|Biological|Siltuximab|Given IV
16010892|NCT02805855|Drug|Autologous Adipose-Derived Mesenchymal Stromal Cells|Human, autologous, culture expanded, adipose derived, mesenchymal stromal cells (AMSCs) produced on site in the Mayo Clinic Human Cellular Therapy Laboratory using current good manufacturing practices (cGMPs).
16010893|NCT02805842|Drug|Tacrolimus BID|Administration of Tacrolimus BID
16010894|NCT02805842|Drug|Advagraf QD|administration of Advagraf QD
16010895|NCT02805829|Drug|Trastuzumab + NK cells|NK cellular therapy conduct 2 cycles per year. Herceptin initial dose of 8 mg/kg over 90 minutes IV infusion, followed by 6 mg/kg over 30 to 90 minutes IV infusion every 3 weeks till to disease progress.
16010896|NCT02805803|Other|Quality of life questionary|Patients will be asked to fill out the questionaries before treatment initiation and at 3, 6 , 12 and 24 months after antibiotherapy initiation.
16010897|NCT02805790|Drug|Elamipretide|4 weeks of treatment with 40 mg elamipretide administered once daily subcutaneously
16010898|NCT02805790|Drug|Placebo|4 weeks of treatment with placebo administered once daily subcutaneously
16010899|NCT02805777|Device|CPAP mask|A new vent CPAP mask system will be used in this trial
16010900|NCT02805764|Device|Homeoblock|A removable, functional dental appliance to be worn nightly for 1 year Pending 510(k) clearance for the use of reducing snoring and mild to moderate obstructive sleep apnea in adults. A class II medical device.
16010901|NCT02805751|Device|Early loading on a training pedal|The patients will perform early loading by using a special training pedal for 5 weeks, starting 2 weeks after the rupture. The patients will remove the walker and train twice a day on this pedal.
16010902|NCT02805751|Other|Tendon strain exercises|The patients will perform tendon strain exercises 3 times each day from 2 weeks after the rupture.
16010903|NCT02805751|Other|Early weight bearing|The patients are allowed to bear weight as much as tolerated in the walker from day 1.
16010904|NCT02805738|Drug|CKD-390|CKD-390 1 Tablet (48 weeks)
16010905|NCT02805738|Drug|viread|viread1 Tablet (24 weeks), CKD-390 1 Tablet (from 24 weeks to 48 weeks)
16010906|NCT02805725|Drug|Phase 1: Trabectedin|"A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.)
~Patients will be allocated 4 doses of Trabectedin following a 3 + 3 design:"
16010907|NCT02805725|Drug|Phase 2: Trabectedin|All patients will be treated at the RP2D of trabectedin defined in the preliminary phase I trial with the same schedule as in the phase I trial.
16010908|NCT02805725|Drug|Phase 1: Cyclophosphamide|A treatment cycle consists of 4 weeks. Treatment may continue until disease progression or study discontinuation (withdrawal of consent, intercurrent illness, unacceptable adverse event or any other changes unacceptable for further treatment, etc.) Cyclophosphamide will be administered bi-daily (50 mg x 2), and given on a week on/week off schedule.
16010909|NCT02805725|Drug|Phase 2: Cyclophosphamide|All patients will be treated with metronomic cyclophosphamide with the same schedule as in the phase I trial.
16010910|NCT02805712|Other|Verbal Information and Discussion|Intervention patient will receive a outpatient session with a palliative care social worker in the heart failure clinic two weeks post discharge consent focusing on goals of care.
16010911|NCT02805712|Other|Control|The control group will receive usual written care material and a palliative care consult if ordered by physician.
16010912|NCT02805699|Drug|Baofeikang Granule|To observe the efficacy and safety of Baofeikang granules on Combined Pulmonary Fibrosis and Emphysema Treatment.Baofeikang Granules consist of（Codonopsis 30g, Cordyceps fungi powder 12g, ophiopogon root 10g, Schisandra 10g, angelica 15g, Bulbus Fritillariae thunbergii 10g, Sophora flavescens 10g,Forsythia suspensa 12g，Pinellia 10g, saponins thorn 10g, Radix Peucedani 10g）.1 bags,P.O（Oral）twice of each 3 months cycle.
16010913|NCT02805699|Drug|Placebo|On the basis of comprehensive treatment of spasmolysis antiasthmatic and anti-inflammatory, expectorant, cough ， give Chinese medicine placebo,1 bags,P.O（Oral）twice of each 3 months cycle.
16010914|NCT02805686|Device|spectral domain optical coherence tomography|
16010915|NCT02805686|Device|multifocal electroretinogram|
16010916|NCT02805673|Procedure|Osteopathy|
16010917|NCT02805660|Drug|Mocetinostat - 50 mg|Participants received mocetinostat three times weekly as an oral capsule.
16010918|NCT02805660|Drug|Mocetinostat - 70 mg|Participants received mocetinostat three times weekly as an oral capsule.
16010919|NCT02805660|Drug|Mocetinostat - 90 mg|Participants received mocetinostat three times weekly as an oral capsule.
16010920|NCT02805660|Drug|Mocetinostat - Recommended Phase 2 Dose (70 mg)|Participants received mocetinostat three times weekly as an oral capsule, at the dose recommended after Phase 1 (70 mg).
16010921|NCT02805660|Drug|Durvalumab - 1500 mg|Participants received durvalumab as an intravenous infusion every 4 weeks.
16010922|NCT02805634|Other|Nine Hole Test|The Nine Hole Pegs technique is a simple manual dexterity test, commonly used in ergotherapy. The participant tries to place 9 pegs in a 9 holes perforated plate, and then tries to remove them as quickly as possible. The hand must stay in a depression within the plate, thereby insuring a constant distance between the hand and the pegs.
16010923|NCT02805634|Device|Triple Stimulation Technique|TST (Triple stimulation technique) combines two techniques used in neurologic diagnosis: magnetic stimulation and electroneuromyography. It is based on the principle of two collisions between the descending central stimulation (magnetic stimulation) and the ascending peripheric stimulation. TST allows to better quantify central nervous system diseases. The abnormal amplitude registered by TST is proportional to the intensity of conduction disorders. The evaluation of these disorders is more precise than with the magnetic stimulation technique alone.
16010924|NCT02805608|Drug|Injection of 68Ga-NOTA-AE105|One injection intravenously of 68Ga-NOTA-AE105
16010925|NCT02805608|Drug|Injection of 18F-FDG|One injection intravenously of 18F-FDG
16010926|NCT02805608|Device|Positron Emission Tomography and CT|Following of injection of 68Ga-NOTA-AE105 the patients will be PET/CT scanned starting 20 minutes post injection
16010927|NCT02805608|Device|Positron Emission Tomography and MRI|Following injection of 18F-FDG the patients will be PET/MRI scanned starting 60 minutes post injection
16010928|NCT02805595|Drug|23.4% Hypertonic saline|
16010929|NCT02805595|Drug|Saline|
16010930|NCT02805582|Drug|10ml ropivacain 0.5%|Ultrasound guided nerve block
16010931|NCT02805569|Device|articulating stylet|patient who intubated with articulating stylet
16010932|NCT02805569|Device|conventional stylet|patient who intubated with conventional stylet
16010933|NCT02805556|Drug|BMS-663068|Single oral dose of BMS-663068
16010934|NCT02805556|Drug|BMS-626529|Single intravenous dose of [13C]BMS 626529
16010935|NCT02805543|Device|Color doppler imaging|
16010936|NCT02805530|Other|First line systemic treatment|Epidermal growth factor receptor (EGFR)-mutated with tyrosine kinase inhibitors (afatinib, erlotinib or gefitinib). Patients without driver mutation duplet of chemotherapy based on platin taking account histologic subtype (Carboplatin or Cisplatin plus pemetrexed for adenocarcinomas, gemcitabine for epidermoid or paclitaxel for both) at discretion of the treating physician.
16010937|NCT02805530|Other|Radical treatment|to the primary and to the metastases will be with surgery, radiotherapy, chemoradiotherapy, stereotactic radiosurgery or radiofrequency ablation.
16010938|NCT02805530|Radiation|radiation therapy|Patients will receive dose and fraction regimen according to the metastatic site.
16010939|NCT02805530|Other|Chemoradiotherapy|Chemoradiotherapy with duplet based on platins (Carboplatin or cisplatin plus pemetrexed or paclitaxel or etoposide or vinorelbine) or monotherapy with carboplatin.
16010943|NCT02805491|Other|meconium|to evaluate internal exposure to pesticide
16010944|NCT02805491|Other|self questionnaires to parents|to evaluate external exposure to pesticide
16010945|NCT02805478|Other|There is no intervention|This is a prospective observational cohort study without any intervention
16010946|NCT02805465|Device|CRT Device and Bi-ventricular pacing|Bi-ventricular pacing by a CRT device
16010947|NCT02805465|Device|CRT Device and His-bundle Pacing|His-bundle pacing by a CRT device through the pacing lead at His-bundle region
16010948|NCT02805452|Drug|Succinate of Solifenacin|
16010949|NCT02805452|Drug|Placebo of Succinate of Solifenacin|
16010950|NCT02805439|Drug|S47445 15mg|One tablet of S47445 15 mg taken orally once a day during breakfast concomitantly to the current selective serotonin reuptake inhibitor treatment, starting the day after inclusion visit and ending the day of the W8 visit.
16010951|NCT02805439|Drug|S47445 50mg|One tablet of S47445 50 mg taken orally once a day during breakfast concomitantly to the current selective serotonin reuptake inhibitor treatment, starting the day after inclusion visit and ending the day of the W8 visit.
16010952|NCT02805439|Drug|Placebo|One tablet of placebo taken orally once a day during breakfast concomitantly to the current selective serotonin reuptake inhibitor treatment, starting the day after inclusion visit and ending the day of the W8 visit.
16010953|NCT02805426|Drug|Tranexamic Acid|
16010954|NCT02805426|Drug|Placebo|
16010955|NCT02805426|Drug|Misoprostol|
16010956|NCT02805413|Other|Détermination and comparison of blood pressure|Rebreathings will be performed every parabola (2, 4, 6, 8, 10…). Ultrasound measurements will be performed during the remaining parabolas (1, 3, 5, 7, 9…). The procedure consists of a fixed breathing frequency of 20 breaths per minute and an exact triggered start point for the measurements. . Central blood pressure measurements, finger blood pressure measurements, impedance cardiography, carotid plethysmography and phonocardiography will be performed continuously during the flights. The breaks between parabolas 10 and 11 and 20 and 21 will be used to change subjects, which takes approximately 5 minutes.
16010957|NCT02805400|Other|determination of cortical activity|"Cortical activity will be determined under changing gravity level by electroencephalography (EEG/LORETA). Brain hemodynamics change will be evaluated by NIRS. Heart rate and respiratory evaluation will be indicators of cardio-vascular and central nervous arousal and stress. Cognitive performance will be evaluated by computerized tests.
~For these methods only commercially available CE marked devices will be used."
16010958|NCT02805387|Dietary Supplement|Treatment|Bicarbonate was ingested
16010959|NCT02805374|Drug|ASP1517|Oral
16010960|NCT02805348|Drug|Bixalomer|Oral
16010961|NCT02805335|Device|KTFIX PLUS|
16010962|NCT02805322|Device|ARC InstaTemp MD|Measurement of Body Temperature using an Infrared Non-Touch Thermometer - Experimental arm.
16010963|NCT02805322|Device|Covidien Genius 2 Tympanic Thermometer|Measurement of Tympanic Temperature using a standard approved method - Control arm.
16010964|NCT02805322|Device|Welch Allen SureTemp Plus Sublingual Thermometer|Measurement of Sublingual Temperature using a standard approved method - Control arm.
16010965|NCT02805309|Behavioral|Exercise|Exercises will target balance, flexibility, strength, and endurance (source: https://go4life.nia.nih.gov/). Home visits will take place twice a week for week 1 and 2; once a week for week 3 and 4; every other week for week for week 5 through week 8. Participants are instructed to do prescribed exercises for 30 minutes daily. The duration of this intervention is about 40 mins.
16010966|NCT02805309|Behavioral|Cognitive behavioral interventions|The following cognitive-behavioral strategies will be employed: 1) enhance positive beliefs about exercise through discussion of benefits of exercise; 2) discussion of barriers to exercise; 3) individualized goal setting and self-monitoring progress using exercise calendar; 4) develop a detailed exercise plan on how, what, when, and where to conduct exercise; 5) $10 rewards for exercising ≥30 mins per day for ≥5 of 7 days. The duration of this intervention is about 20 mins.
16010967|NCT02805309|Behavioral|Attention control education program|A health care professional will call the participant weekly for a period of 8 weeks to teach general tips about exercise and diet (source: https://go4life.nia.nih.gov/). No recommendations for a specific exercise program will be made, except for walking 30 minutes daily or as tolerated. Each telephone session will cover 4 exercise tips and 4 healthy eating tips. The duration of the intervention is about 30 minutes.
16010968|NCT02805296|Other|Light irradiance|Comparison of double vs. single phototherapy
16011106|NCT02804126|Device|Needle|Ultrasound-guided, Stimuplex ultra 360 needle will be used in the study
16011521|NCT02800954|Biological|blood samples|
16010969|NCT02805270|Other|medication reconciliation intervention|medication reconciliation intervention comprises medication reconciliation on admission and discharge, bedside medication counseling and take-home medication list
16010970|NCT02805257|Drug|Mitomycin-C|Intraoperative and postoperative injections of mitomycin-c/Mitosol
16010971|NCT02805257|Other|Balanced Salt Solution|Intraoperative and postoperative injections of BSS
16010972|NCT02805257|Procedure|Ahmed Glaucoma Valve Implant|Implantation of Ahmed Valve in study eye
16010973|NCT02805244|Drug|JTZ-951, 14C-JTZ-951|
16010974|NCT02805231|Other|Vitamin D receptor polymorphic analysis|
16010975|NCT02805218|Drug|PEG-rhG-CSF|
16010976|NCT02805205|Drug|PEG-rhG-CSF|
16010977|NCT02805192|Device|Size Measurement by a Smart phone App|
16010978|NCT02805179|Radiation|High Dose Radiation|Radiation will be delivered once daily for a total of 30 fractions, five days per week.
16010979|NCT02805179|Drug|Temozolomide|Patients will receive concurrent temozolomide (75 mg/m^2 daily for 6 weeks). Adjuvant temozolomide will be given at 150-200 mg/m^2, D1-5 every 28 days for a minimum of six cycles and will be started approximately four weeks following completion of radiotherapy.
16010980|NCT02805166|Drug|PEG-rhG-CSF|
16010981|NCT02805153|Drug|PEG-rhG-CSF|
16010982|NCT02805153|Drug|rhG-CSF|
16010983|NCT02805140|Behavioral|Virtual exercise|Using videoconferencing, mothers assigned to intervention arm will participate in daily (weekdays) virtual exercise sessions for 6 weeks with other mothers.
16010984|NCT02805140|Behavioral|Mobile apps|During virtual exercise sessions, mothers assigned to intervention arm will follow exercise routines using mobile exercise apps that are recommended by study staff.
16010985|NCT02805140|Behavioral|Exercise resources and information|For all mothers, the investigators will provide standard information on the benefits of exercise and link to existing public health resources on how to start and stay active.
16010986|NCT02805101|Drug|Biodentine|Biodentine is going to be used as the sealing agent for the perforation.
16010987|NCT02805101|Drug|MTA|MTA is going to be used as the sealing agent for the perforation.
16010988|NCT02805088|Other|Electroencephalographic recordings|
16010989|NCT02805088|Other|neuropsychological evaluation|
16010990|NCT02805088|Other|clinical evaluation of symptoms|
16010991|NCT02805075|Other|Fructooligosaccharide|Given PO
16010992|NCT02805075|Other|Laboratory Biomarker Analysis|Correlative studies
16010993|NCT02805062|Procedure|Digital Pleural Manometry|Measurement of intra-pleural pressure and the removal of pleural fluid.
16010994|NCT02805062|Procedure|Magnetic Resonance Imaging|Subject lies a long tunnel shaped scanner and images are recorded.
16010995|NCT02805049|Drug|Echinocandins|The patients included in this protocol require routine treatment with caspofungin or micafungin. Though this intervention is under study, it is not modified by this protocol.
16010996|NCT02805036|Device|echocardiography|• Prospective, simultaneous recording of the cardiac output (measured non-invasively via transthoracic echocardiography) and a number of parameters commonly monitored in the surgical intensive care unit (CVP, SBP/DBP/MBP).
16010997|NCT02805036|Device|Arterial oximetry|measured by co-oximetry of a blood sample taken via the arterial catheter implemented for critical care
16010998|NCT02805023|Biological|BGC101 (autologous EnEPC preparation)|Intramuscular injections - single treatment session
16010999|NCT02805023|Biological|Control medium|Intramuscular injections - single treatment session
16011000|NCT02805010|Drug|Abatacept|On Day 1, subjects will receive a single SC dose of abatacept 125mg
16011001|NCT02805010|Other|Placebo|On Day 1, subjects will receive a single SC dose of placebo
16011002|NCT02804984|Genetic|ICUS|
16011003|NCT02804958|Procedure|STEMI treated with primary PCI|Primary percutaneous coronary intervention was performed according to the current standard guidelines. Coronary angiography was performed using standard techniques. The use of thrombectomy devices, intravascular ultrasound, intra-aortic balloon pump, and percutaneous cardiopulmonary support was up to the operator.
16011004|NCT02804945|Biological|Mesenchymal Stem Cells (MSCs)|Participants receive a maximum dose of 3 x 10^6 cell/Kg by vein one time on Day 1.
16011005|NCT02804932|Dietary Supplement|Super Beets|Nitrate rich beetroot powder (10g/day) for 8 weeks
16011006|NCT02804932|Other|Super Beets Placebo|Nitrate deficient beetroot powder (10g/day) for 8 weeks
16011007|NCT02804919|Device|Fisher & Paykel Healthcare CPAP Device|Fisher & Paykel Healthcare CPAP Device
16011008|NCT02804906|Behavioral|Home-based physical therapy|"Participants will be visited by a physical therapist 3 times a week for approximately 1 hour each day, for a duration of 4 weeks. These visits will serve to encourage adherence to the intervention, reinforce activities recommended at discharge, monitor safety under direct supervision, and adjust the exercise prescription if/as needed (e.g. advance recommended activity level) if necessary. Patients will also be provided with a tablet computer device installed with software, Moving Analytics, that will reinforce the cardiac rehabilitation program through daily reminders and easily accessible visual activity plans. This program will be updated by the physical therapist during home visits as the program advances. Daily patient-reported health status (Your Activities of Daily Living) 26 will be ascertained on the same tablet device by participants three times per week using open source software designed."
16011009|NCT02804906|Behavioral|Usual Care|"Participants in the control arm will be provided with a 30-minute counseling session on risk factor modification prior to discharge. Participants will be provided with a tablet computer device to complete patient-reported health status (Your Activities of Daily Living) 26 three times per week using open source software designed. Participants will be visited by the Research Coordinator or member of the study team at one month post-hospital discharge to perform a follow-up assessment that will include ADLs, IADLs, SF-12 PCS, frailty measures, and questions on healthcare utilization (hospital readmissions)."
16011010|NCT02804893|Procedure|VATS|Thorax thoracoscopic surgery (lobectomy)
16011011|NCT02804893|Procedure|RATS|Thorax robotic surgery (lobectomy)
16011063|NCT02804490|Dietary Supplement|Provitamin A carotenoid biofortified maize|Women and their infants will receive 2 meals/day prepared with provitamin A carotenoid biofortified orange maize flour (287 g dry weight/d for women; 50 g dry weight/d for infants), 6 days/week for 15 weeks
16011107|NCT02804126|Drug|Paracetamol|Intravenous paracetamol will be used (1.0 gram), up to 4 grams per day
16011012|NCT02804880|Behavioral|HAR|Smokers will be introduced to various smoking cessation (SC) services in Hong Kong (using the referral card) and be motivated to use the services. Field research staff will assist on-site booking SC services for smokers. Tailored messages, including: harm of smoking, benefit of smoking cessation, importance of adherence to smoking cessation appointment and encouragement on abstinence will be sent via instant messaging (IM) services (e.g. WhatsApp, WeChat) to smokers after initial contact.
16011013|NCT02804880|Behavioral|LTM|Fix-schedule SMS messages will be sent to encourage them to book the smoking cessation services appointment. Smokers are required to book the SC appointments by themselves.
16011014|NCT02804880|Behavioral|AWARD|Ask about smoking history, Warn about the high risk of smoking, Advise to quit as soon as possible, Refer to the smoking cessation services, and Do it again: to repeat the intervention during tel. follow-ups.
16011015|NCT02804880|Other|Referral card|"The 3-folded Smoking Cessation Services card consists of brief information and highlights of existing smoking cessation services, contact methods, motivation information and strong supporting messages or slogans."
16011016|NCT02804880|Other|A4 leaflet|The 2-side color printed A4 leaflet, which systematically covers the most important messages to motivate smoking cessation
16011017|NCT02804880|Behavioral|Brief advice|Very brief, minimal and general smoking cessation advice
16011018|NCT02804880|Other|12-page booklet|12-page smoking cessation self-help booklet
16011019|NCT02804867|Procedure|Online questionnaire and self-administered blood spot|
16011020|NCT02804854|Drug|Neutrophil Activation Probe (NAP)|Delivery of NAP by direct pulmonary administration followed by fibreoptic confocal microendoscopy. A total of 240 mcg (±25%) in three divided doses of 80 mcg (±25%).
16011021|NCT02804841|Dietary Supplement|Cholecalciferol -Vitamin D3|
16011022|NCT02804841|Other|Placebo -gel capsule containing no vitamin D.|
16011023|NCT02804828|Dietary Supplement|Individualized mitochondrial cocktail|Nutrient cocktail comprising: thiamine, nicotinamide, pantothenic acid, riboflavin, L-carnitine, alpha lipoic acid, CoQ10, vitamin C, vitamin E, and omega 3 fatty acids (Cod Liver Oil).
16011024|NCT02804828|Dietary Supplement|Placebo|6 months for the double-blind phase
16011025|NCT02804815|Drug|Aspirin 100mg|Aspirin 100mg
16011026|NCT02804815|Drug|Aspirin 300mg|Aspirin 300mg
16011027|NCT02804815|Drug|Placebo 100mg|Placebo 100mg
16011028|NCT02804815|Drug|Placebo 300mg|Placebo 300mg
16011029|NCT02804802|Other|questionnaire|dietary habits and physical activity questionnaire
16011030|NCT02804776|Drug|Gefitinib|250mg oral daily for 4 weeks
16011031|NCT02804763|Drug|Placebo|Solution for infusion, 0,9% saline
16011032|NCT02804763|Drug|Dapirolizumab pegol (DZP)|Solution for infusion
16011033|NCT02804750|Drug|CORT125134|
16011034|NCT02804737|Device|Aiddly (Web Site)|A website designed to better educate patients on how to prepare for their colonoscopies
16011035|NCT02804724|Other|No intervention|
16011036|NCT02804711|Biological|Low dosage of Staphylococcus aureus vaccine (15µg/0.6ml)|
16011037|NCT02804711|Biological|Middle dosage of Staphylococcus aureus vaccine (30µg/0.6ml)|
16011038|NCT02804711|Biological|High dosage of Staphylococcus aureus vaccine (60µg/0.6ml)|
16011039|NCT02804711|Biological|Placebo|
16011040|NCT02804698|Behavioral|Education intervention|13-week educational and physical activity intervention
16011041|NCT02804685|Other|exercise protocol|The multi-intervention exercise protocol consists in a performance of agility, strength and balance exercises. It has to be fulfilled during 6 weeks (twice a week) before the regular training performance. The exercises should be done for almost 15 minutes approx. There will be 6 exercises in total: squat with toe raise, one-leg squats, single-leg balance (throwing a ball with a partner), vertical jumps, hamstring exercise, quick forwards and backwards sprints.
16011042|NCT02804659|Other|microRNA|Extraction of the microRNA using the mirVana miRNA isolation kit and quantification using real-time PCRs
16011043|NCT02804646|Drug|recombinant human endostatin|endostar was continuous intravenous transfusion for 7 days，with the dose of 15mg/m2 for one day
16011044|NCT02804646|Drug|pemetrexed plus cisplatin or carboplatin|the dose of pemetrexed was 500mg/m2 on day 1 of every 21 days,plus cisplatin or carboplatin.
16011045|NCT02804633|Drug|IV Acetaminophen|1 gram every 6 hours
16011046|NCT02804633|Drug|Placebo|100 ml of normal saline every 6 hours
16011047|NCT02804620|Behavioral|Peer-led, Empowerment-based Approach to Self-management efforts in Diabetes|The investigators will train patients with type 2 diabetes who are well-controlled and pair them up with participants. Peer leaders will help the participants overcome their problems and teach them how to make changes by 5 step goal setting strategy. The peer leaders never give advice on any medical condition. All the medical questions will be referred to the research team.
16011048|NCT02804607|Other|questionnaire|
16011049|NCT02804594|Drug|N-acetyl cysteine|1250 mg of N- acetyl cysteine taken three times daily
16011050|NCT02804594|Drug|Placebo|placebo taken three times daily
16011051|NCT02804581|Dietary Supplement|Gum Arabic|Oral intake of GA in powder from30 grams per day
16011052|NCT02804568|Drug|ALKS 3831|Oral capsule, daily administration
16011053|NCT02804555|Other|Oxygen|Oxygen administration
16011054|NCT02804542|Other|Observational|
16011055|NCT02804542|Other|Retrospective review|
16011056|NCT02804529|Device|Veress needle|
16011057|NCT02804516|Behavioral|the nurse did early mobilization|the nurses know and do what is the early mobilization in ICU
16011058|NCT02804516|Behavioral|the nurse do not do early mobilization|the nurses do not know and do what is the early mobilization in ICU
16011059|NCT02804503|Behavioral|Calorie Labels|Participants were asked to order food from the assigned menu as if they were having lunch in a fast food restaurant.
16011060|NCT02804503|Behavioral|Exercise Labels|Participants were asked to order food from the assigned menu as if they were having lunch in a fast food restaurant.
16011061|NCT02804503|Behavioral|No Labels|Participants were asked to order food from the assigned menu as if they were having lunch in a fast food restaurant.
16011062|NCT02804490|Dietary Supplement|Conventional white maize|Women and their infants will receive 2 meals/day prepared with conventional white maize flour (287 g dry weight/d for women; 50 g dry weight/d for infants), 6 days/week for 15 weeks
16071168|NCT02374567|Drug|Galantamine|
16011064|NCT02804490|Dietary Supplement|Preformed vitamin A fortified maize|Women and their infants will receive 2 meals/day prepared with preformed vitamin A fortified, conventional white maize flour (287 g dry weight/d for women; 50 g dry weight/d for infants), 6 days/week for 15 weeks
16011065|NCT02804451|Device|Macintosh laryngoscope|intubation with standard macintosh larygoscope; gold standard
16011066|NCT02804451|Device|TruView EVO2 laryngoscope|A TruView EVO2 laryngoscope with blade size 3 (EVO2; Truphatek Holdings, Ltd., Netanya, Israel),
16011067|NCT02804451|Device|TruView EVO2 PCD laryngoscope|A TruView EVO2 PCD laryngoscope with blade size 3 (PCD; Truphatek Interbational Ltd., Netanya, Israel),
16011068|NCT02804451|Device|ETView SL|An ETView SL (ETView; ETViewLtd, Misgav, Israel) ednotracheal tube
16011069|NCT02804425|Other|actor-spectator|"actor-spectator group : actor at least once during the simulation session"
16011070|NCT02804412|Other|Control group|This is the control group with 14 h treatment over 10 workdays.
16011071|NCT02804412|Other|CIAT-group|Examine the efficacy of CIAT (30 h over 10 workdays) versus Control-group and communication treatment group.
16011072|NCT02804412|Other|communication treatment group (CTG)|Examine the efficacy of CTG (30h over 10 wokrdays) versus CIAT-group and control group
16011073|NCT02804399|Drug|PF-06463922|100 mg oral dose on day 1 in period 1 and on day 8 in period 2
16011074|NCT02804399|Drug|rifampin|600 mg QD from day 1 to day 12 in period 2.
16011075|NCT02804386|Drug|Sofosbuvir|Sofosbuvir (formerly known as GS-7977) is a direct-acting nucleotide polymerase inhibitor that is being developed as an oral drug for the treatment of chronic HCV infection
16011076|NCT02804373|Drug|Oxytocin (OXT) continuous|Administration of 24 IU of oxytocin daily during 28 days
16011077|NCT02804373|Drug|Placebo|Placebo daily during 28 days
16011078|NCT02804373|Drug|Placebo continuous|Placebo administration the following 2 days after each OXT administration, during 28 days.
16011079|NCT02804373|Drug|Oxytocin|Administration of 24 IU of oxytocin every 3 days during 28 days.
16011080|NCT02804360|Device|dexamethasone injection|intravitreal dexamethasone in retinitis pigmentosa cystoid macular edema
16011081|NCT02804347|Device|Cognitive Function Imaging and Battery|Individuals will be placed in the fMRI scanner and complete the NBACK Cognitive Task
16011082|NCT02804347|Device|Sniffin Sticks|Using Sniffin Sticks, olfactory functioning will be assessed using three tests: identification, discrimination, and threshold.
16011083|NCT02804347|Other|Cognitive Batteries|Participants will conduct the following cognitive batteries: DSST, TMT A & B, RAVLT
16011084|NCT02804334|Procedure|Psychiatric Questionnaires|
16011085|NCT02804334|Procedure|Blood draw|
16011086|NCT02804308|Behavioral|Combined Training|
16011087|NCT02804295|Other|Collaborative Care Intervention|All eligible subjects that meet the eligibility requirements for approach and consent and have a positive screen for PDM will complete a baseline survey and will be enrolled into the intervention condition. This is an open trial and thus all consenting eligible subjects will receive the intervention.
16011088|NCT02804282|Combination Product|sc2Wear Furosemide|Drug-device combination product of buffered furosemide injection, (Furosemide Injection Solution), 8 mg/mL, and patch pump (sc2Wear Furosemide Pump)
16011089|NCT02804269|Other|Cardiovascular Magnetic Resonance|For the evaluation of heart function and structure of the cardiovascular system.
16011090|NCT02804269|Other|Fatmass measurement|It utilizes a scale machine to measure the body fat and skeletal muscle percentage
16011091|NCT02804256|Other|Blood Sample Collection|10 patients with ICCs to provide a second blood sample (20mls - 2 tablespoons) on top of the samples that will be collected for the biorepository.
16011092|NCT02804243|Device|nasal high flow therapy|The nasal high flow therapy has enabled high flow oxygen to be derived through nasal cannula. This mode not only allows constant FiO2 during peak inspiratory flow but also confers benefits including a low level of continuous positive airway pressure with increased end-expiratory lung volume and reduced work of breathing, partly through intrinsic positive end-expiration pressure compensation and dead space washout. The inspired gases are warmed and humidified, improving comfort and possibly reducing airway inflammation, leading to improved drainage of respiratory secretions.
16011094|NCT02804217|Other|Genetic: mutation profile|
16011095|NCT02804204|Drug|Anti-TNF|
16011096|NCT02804191|Drug|LO2A|eye drop solution.
16011097|NCT02804191|Drug|Saline|Placebo
16011098|NCT02804178|Drug|ATR-101|125-1000 mg twice per week
16011099|NCT02804165|Genetic|Enterovirus vaccination|Enterovirus vaccination in genetically predisposed subjects having a high risk to develop type 1 diabetes.
16011100|NCT02804152|Behavioral|CBT for Chronic Pain in Pregnancy|"The content will be included in 8 weekly sessions, i.e., sessions 1-3 (Education on chronic pain, Theories of pain and diaphragmatic breathing and Progressive muscle relaxation and visual imagery), sessions 4 and 5 (Automatic thoughts and pain and Cognitive restructuring), sessions 7, 8 and 10 (Pleasant activity scheduling, Time-based pacing and Sleep hygiene), sessions 6 and 9 (Stress management and Anger management). Following this content, 1-2 sessions will be dedicated to review and reinforcement of key concepts or addressing any stuck points as well as cover content in session 11 (Relapse Prevention). The last session of therapy would include a review of achievements and commitment to continued application of CBT for chronic pain in participants daily lives."
16011101|NCT02804139|Other|Standard care plus physical therapy|Subjects attend 1 to 2 physical therapy sessions per week for 6 weeks beginning 8-10 weeks post-C section. The physical therapy program includes scar management, core retraining, and lumbar and pelvic joint mobilization.
16011102|NCT02804139|Other|Standard Care|Standard Care after C-section with no additional physical therapy.
16011103|NCT02804126|Procedure|TAP (transversus abdominis plane block)|ultrasound-guided regional block between abdominal wall muscles to treat acute postoperative pain. Stimuplex Ultra 360 needle will be used and 0.25% bupivacaine administered (0.2 mL/kg).
16011104|NCT02804126|Procedure|QL (quadratus lumborum block)|ultrasound-guided regional block between abdominal wall muscles to treat acute pain, similar to transversus abdominis plane block, but with distribution of local anesthetic towards paravertebral space. Stimuplex Ultra 360 needle will be used and 0.25% bupivacaine administered (0.2 mL/kg).
16011105|NCT02804126|Drug|Bupivacaine|In both groups (TAP&QL) 0.25% bupivacaine will be given (0.2 mL/kg)
16011108|NCT02804126|Drug|Metamizol|Intravenous metamizol will be used (1.0 gram), up to 4 grams per day
16011109|NCT02804126|Drug|Ketoprofen|Intravenous ketoprofen will be used (0.1 gram), up to 200 milligrams per day
16011110|NCT02804126|Drug|Morphine|Intravenous morphine (5 mg) will be given when pain exceeds 40 mm in VAS (maximum 2 doses per day)
16011111|NCT02804113|Device|Supera Peripheral Stent System|
16011114|NCT02804074|Other|Optimization of antihypertensive treatment based on office BP|Optimization of antihypertensive treatment based on office BP
16011115|NCT02804074|Other|Optimization of antihypertensive treatment based on 24-hour ABPM|Optimization of antihypertensive treatment based on 24-hour ABPM
16011116|NCT02804061|Behavioral|NELIP|
16011117|NCT02804048|Other|superficial heat pelvic floor muscle|Superficial heat application in the pelvic floor muscle
16011118|NCT02804048|Other|superficial heat low back|Superficial heat application in the low back
16011119|NCT02804048|Other|Pelvic Floor Muscle Training|Pelvic floor muscle training exercises
16011120|NCT02804048|Other|Manual therapy in iliopsoas, diaphragm and piriformis|Manual therapy in iliopsoas, diaphragm and piriformis for 10 minutes
16011121|NCT02804048|Other|Intra Vaginal Manual therapy|Intra Vaginal Manual therapy in the pelvic floor muscles
16011122|NCT02804048|Other|Electromyographic biofeedback|Electromyographic biofeedback in the pelvic floor muscles
16011123|NCT02804035|Combination Product|sc2Wear Furosemide|Drug-device combination product of buffered furosemide injection, (Furosemide Injection Solution), 8 mg/mL, and patch pump (sc2Wear Furosemide Pump)
16011124|NCT02804022|Device|VPIA analgesia|Recruited subjects will be given a VPIA device containing 1mcg/ml of morphine. Morphine will be administered via an intravenous infusion line with an anti-reflux valve to ensure precise drug administration and no backflow.
16011125|NCT02804022|Drug|Morphine|Recruited subjects will be given a VPIA device containing 1mcg/ml of morphine. Morphine will be administered via an intravenous infusion line.
16011126|NCT02803996|Drug|Aramchol|Part A: Aramchol oral tablets at 400 mg or 600 mg single dose Part B: Aramchol oral tablets at 400 mg or 600 mg multiple dose for 10 consecutive days.
16011127|NCT02803996|Drug|Placebo|Part A: Placebo oral tablets single dose Part B: Placebo oral tablets multiple dose for 10 consecutive days.
16011128|NCT02803983|Procedure|Pediatric hip plate|Children were treated with pediatric hip plate.
16011129|NCT02803983|Procedure|Cannulated screw|Children were treated with cannulated screw.
16011130|NCT02803957|Device|NeoChord DS1000|Trans-apical, beating heart repair of degenerative mitral valve insufficiency with artificial chordae implanted with the NeoChord DS1000
16011131|NCT02803957|Device|Surgical Mitral Valve Repair|Surgical repair of degenerative mitral valve insufficiency with cardiopulmonary bypass, and annuloplasty ring and some form of leaflet repair or artificial chordae.
16011132|NCT02803944|Drug|Azithromycin|
16011133|NCT02803931|Device|Cardiogoniometry|Cardiogoniometry cardiologic explorer, Enverdis GmbH medical solutions, Germany
16011134|NCT02803931|Device|12-lead ECG|
16011135|NCT02803918|Drug|Lixisenatide (AVE0010)|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
16011136|NCT02803918|Drug|Placebo|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
16011137|NCT02803918|Drug|Basal Insulin|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
16011138|NCT02803918|Drug|Metformin|"Pharmaceutical form: tablet
~Route of administration: oral"
16011139|NCT02803905|Biological|Biological: Islet transplantation|This is a single procedure protocol. Only a single islet transplant will be performed in the patient. Islets can be isolated from more than one pancreas donor. The final islet product is a sterile suspension of ≥70% viable, ≥30% pure, allogeneic islets. A minimum of 5000 IEQ/KG will be transplanted. Although this study is a single dose protocol, islet transplant recipients with partial islet graft function will be considered for a second islet transplant (intra-hepatic administration) if they do not achieve primary efficacy endpoint criteria at 1 year
16011140|NCT02803892|Drug|rapamycin|Rapamycin will be administered at an initial dose 0.2 mg/kg on day 0, followed by 0.1 mg/kg/die. The daily dose will be adjusted to the whole blood 24-hr trough to target, as tolerated, 8-10 ng/mL
16011141|NCT02803892|Drug|Vildagliptin|Vildagliptin will be administered at a dose of 50 mg x2/die starting from day 0.
16011142|NCT02803892|Drug|Placebo 1|Placebo 1 will be titrated according to a random schedule alternating plausible doses of placebo. After 4 weeks of treatment patients will discontinue placebo 1
16011143|NCT02803892|Drug|Placebo 2|Placebo 2 will be administered BID starting from day 0. After 8 weeks of treatment patients will discontinue placebo 2
16011144|NCT02803879|Device|Cardiogoniometry|
16011145|NCT02803866|Behavioral|Training program CAP-PREM|1ºAfter recruitment parents will fill the PMP S-E tool and the psychological tests evaluating their stress and depression . 2º parents will receive the training program during 4 weeks. 3º: before hospital discharge parents will fill again the PMP S-E tool and the psychological test evaluating their depression and anxiety
16011146|NCT02803853|Behavioral|Intervention|Intervention components will occur at the policy level (working with tribal leaders makers to sustain intervention components; food retail outlet level (working with grocery stores and owners to stock, promote, and sell healthier foods and beverages); neighborhood level (working with worksites and schools to deliver nutrition intervention sessions to youth and adults in intervention neighborhoods); household level (providing a social media program that provides parents and caregivers tips for healthier eating).
16011147|NCT02803840|Radiation|Low-dose radiotherapy|2 x 2 Gy on symptomatic sites only
16011148|NCT02803827|Other|Rapid diagnostics|Participants will have enteric specimens obtained using a flocked rectal swab, which will be transported in 2 mL Cary Blair medium. These will be tested using the BioMerieux BioFire FilmArray GI panel.
16011149|NCT02803827|Biological|Probiotic|The probiotic given will be Lactobacillus reuteri DSM 17938, 5x10e8 cfu/mL x 60 days, suspended in vegetable oil.
16011150|NCT02803827|Other|Placebo|The placebo will be the vegetable oil vehicle and look identical to the probiotic.
16011522|NCT02800954|Biological|Bone marow samples|
16011151|NCT02803814|Procedure|Superior mesenteric artery approach for pancreatoduodenectomy|Pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area using the superior mesenteric artery approach
16011152|NCT02803814|Procedure|Classic approach for pancreatoduodenectomy|Pancreaticoduodenectomy in tumors of the head of the pancreas and peripancreatic area using the classical approach
16011153|NCT02803801|Behavioral|Build Your Parenting Toolkit Program|Ten session program, with a mix of parents-only lectures and parent and child Cooking Clubs.
16011154|NCT02803788|Drug|ramosetron, ondansetron, dexamethasone|prevention of post-operative nausea vomiting
16011155|NCT02803775|Device|CRT Algorithm|Programming based on Electrogram measurement
16011156|NCT02803762|Drug|Pacritinib|400 mg [14C]pacritinib (containing 100 μCi radioactivity) administered orally as a single dose following at least a 10-hour fast (not including water) on Day 1
16011157|NCT02803749|Drug|Buspirone|
16011158|NCT02803749|Drug|Placebo|
16011159|NCT02803736|Device|acupuncture|Acupuncture involves the insertion of extremely thin needles through skin at strategic points on human body. Many Western practitioners view the acupuncture as a device to stimulate nerves, muscles and connective tissue, and believe that it can increases blood flow.
16011160|NCT02803723|Procedure|Holding-cuddling|"The Holding-cuddling is started 5 minutes before veinipuncture."
16011161|NCT02803723|Procedure|Sucrose|The sucrose adminstration is started 2 minutes before veinipuncture.
16011162|NCT02803710|Other|Microbiological study|
16011163|NCT02803697|Other|Patients|
16011164|NCT02803684|Other|MRI examination with tensor diffusion protocol acquisition. No injection needed.|standard MRI examination
16011165|NCT02803671|Device|TFU-NIRS|
16011166|NCT02803671|Device|NIRS|
16011167|NCT02803671|Device|EEG|
16011168|NCT02803658|Behavioral|smoking behavior|
16011169|NCT02803658|Biological|Sperm collection|
16011170|NCT02803645|Biological|blood sample|
16011171|NCT02803632|Behavioral|questionnaires|
16011172|NCT02803632|Device|actigraphic recording|
16011173|NCT02803593|Behavioral|Technology-based information and coaching/support program|The TICAA has three components in four languages (English, Mandarin Chinese, Korean, and Japanese): (a) social media sites; (b) interactive online educational sessions; and (c) online resources. The social media sites provide a mechanism by which participants can receive coaching/support from culturally matched peers and health care providers. The educational sessions provide information about general and sub-ethnic- specific topics related to breast cancer survivorship. The online resources include 35 Web links to resources related to breast cancer survivorship from scientific authorities and from general and sub-ethnic-specific health organizations/institutes.
16011174|NCT02803567|Behavioral|Brief psycho-educational intervention|Participants in the intervention arm will receive a computerized brief intervention composed of tailored feedback and psycho-education specific to their chronic condition.
16011175|NCT02803554|Other|Plasma|Blood plasma from donors aged 25 years or younger
16011176|NCT02803541|Behavioral|12 day mainstream summer camp experience|see arm description
16011177|NCT02803528|Drug|Biodentine|Biodentine is going to be used as the direct pulp capping material
16011178|NCT02803528|Drug|MTA|MTA is going to be used as the direct pulp capping material in the second group
16011179|NCT02803515|Biological|peripheral venous blood samples|peripheral venous blood samples measured preoperatively and postoperatively HIPEC (Day 1, day 3 and day 5 postoperative)
16011180|NCT02803502|Device|Chronometric method|Chronometric method of FVIII dosage on STA-R PLC automate (reactive Cephascreen STAGO, Unicalibrateur STAGO, plasma deficient Cryopep, Controls STAGO)
16011181|NCT02803502|Device|Chromogenic method|"Chromogenic FVIII assay method ( BIOPHEN FVIII: C and BIOPHEN Factor IX of the firm Hyphen BioMed)"
16011182|NCT02803502|Device|Thrombin generation test (TGT)|"Briefly: the measurement of thrombin generation is performed by the technique of calibrated and automated Thrombinography (CAT) developed by Hemker HC. This technique allows the simultaneous analysis of multiple samples using a fluorometer (Fluoroscan Ascent, ThermoLabsystems OY, Helsinki, Finland) and a Thrombinoscope® software that converts the fluorescence intensity obtained by concentration of active thrombin. The reagent PPP-reagent Low respectively containing 1pm FT and 4μM phospholipid (PL) as a final concentration will be used."
16011183|NCT02803489|Device|medical device intervention|
16011184|NCT02803463|Procedure|open appendectomy with peritoneal closure|open appendectomy with peritoneal closure under general anesthesia for acute appendicitis
16011185|NCT02803463|Procedure|open appendectomy without peritoneal closure|open appendectomy without peritoneal closure under general anesthesia for acute appendicitis
16011186|NCT02803450|Procedure|Epidural needle|Medication administration via epidural needle.
16011187|NCT02803450|Procedure|Catheter Administration|Medication administration via epidural catheter.
16011188|NCT02803450|Procedure|Standard of Care Epidural Administration|Medication administered at higher concentration, lower volume via epidural catheter.
16011190|NCT02803424|Other|Volume controlled ventilation|During anesthesia and surgical procedure, volume-controlled ventilation will be applied with an inspiration:expiration ratio of 1:2 and a tidal volume of 8 mL per ideal body weight (kg) without ventilatory mode change.
16011191|NCT02803424|Other|Autoflow-volume controlled ventilation|After tracheal intubation, volume-controlled ventilation will be initiated with an I:E ratio of 1:2 and a tidal volume of 8 mL per ideal body weight (kg). Immediately after CO2 pneumoperitoneum with steep Trendelenburg positioning, Autoflow-volume controlled ventilation will be applied instead of volume-controlled ventilation. Immediately after CO2 desufflation and supine positioning, volume-controlled ventilation will be applied again.
16011192|NCT02803398|Other|Compression bandages application and interface pressure measurements|Bandages, which are applied in a spiral pattern on the leg, are composed of Biflex 16 (Thuasne) and/or Rosidal K (Lohmann & Rauscher).
16011193|NCT02803385|Other|Continous Epidural Analgesia|continuous epidural infusion at rate of 5-8 ml /hr based on maximum allowable safe dose as per body weight. The pump settings will be set at 0.1 ml per bolus with lockout interval of 20 minutes. Cross over to other group will occur after 36hours.
16071169|NCT02374567|Drug|Memantine|
16011194|NCT02803385|Other|Patient Controlled Epidural Analgesia|patient controlled epidural analgesia in form of Patient Controlled Analgesia pumps with continuous rate of 5-8ml/hour & demand dose of 2-3 ml p.r.n with a lock out interval of 20 minutes based on maximum allowable safe dose as per body weight .The group will have a cross over at 36 hours postop.
16011195|NCT02803372|Other|Goal-directed circulatory management|In addition to routine monitoring, invasive LiDCOrapid is used to monitor MAP, SVV and CI. Intraoperative circulatory management is performed according to the goal-directed principal, i.e., to maintain MAP > 95 mmHg, SVV < 6%, and CI 3.0-4.0 L/min/m2, started from renal artery clamping and maintained until the end of surgery. Crystalloid solution is firstly infused to maintain SVV at the target level, dobutamine and/or noradrenaline are then infused to maintain MAP and CI at the target levels.
16011196|NCT02803372|Other|Routine circulatory management|Routine monitoring is performed, which include invasive blood pressure and urine output. Intraoperative circulatory management is performed according to routine practice, i.e., to maintain blood pressure within 20% from baseline level and urine output > 0.5 ml/kg/h by infusing crystalloid solution and administering vasoactive drugs when considered necessary.
16011197|NCT02803359|Procedure|Placement of a needle electrode through the thyrohyoid membrane into the submucosal space within the false vocal fold|
16011198|NCT02803346|Other|Circulating blood (leukocytes)|mHLA-DR measurement (in vitro)
16011199|NCT02803333|Other|No Intervention|No intervention
16011200|NCT02803320|Drug|SPF 50 Y65 110 (BAY 987516)|Subjects applied the assigned products to all sun-exposed areas of their face and body liberally and evenly, in accordance with instructions. Sun exposure was divided into two periods. Each period consisted of direct sun exposure (out of water; Cycle A) and water exposure (Cycle B). Cycles A and B were repeated two times before study closeout.
16011201|NCT02803307|Drug|TLC599|Single dose via intra-articular injection
16011202|NCT02803294|Procedure|transcatheter aortic valve replacement|
16011203|NCT02803281|Other|Frailty Assessment|Various physiologic and frailty assessment tests
16011204|NCT02803268|Drug|MT-8554 low dose|
16011205|NCT02803268|Drug|MT-8554 middle dose|
16011206|NCT02803268|Drug|MT-8554 high dose|
16011207|NCT02803268|Drug|Placebo|
16011208|NCT02803255|Device|MAHI Exo-II|
16011209|NCT02803242|Other|Patient Reported Outcomes|
16011210|NCT02803229|Drug|Adderall-XR|
16011211|NCT02803229|Drug|Matched placebo|matched placebo provided for placebo arm
16011212|NCT02803216|Drug|standard triple region|ten days of standard triple region (20mg omeprazole 20mg, 1.0 amoxicillin, 0.5 clarithromycin, Bid).
16011213|NCT02803216|Drug|2-week Xiang-sha-liu-jun decoction|2-week Xiang-sha-liu-jun decoction, bid.
16011214|NCT02803216|Drug|4-week Xiang-sha-liu-jun decoction|4-week Xiang-sha-liu-jun decoction, bid.
16011215|NCT02803203|Drug|osimertinib|
16011216|NCT02803203|Drug|Bevacizumab|
16011217|NCT02803190|Behavioral|ICG|All participants received a CD-ROM and one hour education on osteoporosis, sarcopenia, frailty, fall prevention, nutrition, low back pain, good posture, and coping strategy and another hour of professional led exercise program with focus on central muscle groups. ICG subjects received once weekly group exercise.
16011218|NCT02803190|Behavioral|MTG|All participants received a CD-ROM and one hour education on osteoporosis, sarcopenia, frailty, fall prevention, nutrition, low back pain, good posture, and coping strategy and another hour of professional led exercise program on central muscle groups. MTG subjects received twice weekly machine-based resistance training on major and central muscle groups.
16011219|NCT02803177|Biological|BMC2012|
16011220|NCT02803177|Device|beta-TCP Chronos® Synthes|
16011221|NCT02803164|Device|Wound Vacuum-assisted dressing|The NPWT system (V.A.C. Therapy System, KCI USA Inc.) consisted of a medical-grade non-adherent polyvinyl alcohol white foam applied directly to the infected surface, followed by an open-pore reticulated polyurethane black foam cut to fit the wound and covered by a transparent air-tight adhesive drape. A suction cup with tubing was placed over a small slit on the drape and connected to a suction machine (V.A.C. ULTA Therapy Unit).
16011222|NCT02803164|Other|Control group|Retrospective review of subjects medical records with open chest wounds who were treated with the traditional treatment techniques.
16011223|NCT02803151|Radiation|Stereotactic ablative radiotherapy|SABR with 36 to 45 Gy in six fractions to the defined target volume with met organ-at-risk constraint criteria using intensity modulated radiotherapy or volumetric modulated arc therapy (VMAT or RapidArc). Treatment should be given once per day, 2-3 fractions per week with no more than 2 consecutive daily fractions, over 2 to 2.5 weeks.
16011224|NCT02803138|Drug|Ombitasvir/paritaprevir/ritonavir|Co-formulated tablet
16011225|NCT02803138|Drug|Dasabuvir|Tablet
16011226|NCT02803138|Drug|Ribavirin|Tablet
16011227|NCT02803138|Behavioral|Patient support program|Supportive services provided to participants included reminder calls, emails, text messages, a Care Coach, and educational/informational materials.
16011228|NCT02803125|Behavioral|Psychosocial intervention|This intervention is to be developed during the study. It will likely include modules that provide anger management strategies, communication skills, and education about interpersonal relationships and social support. In addition, psychoeducation about behavioral activation and stress management will likely be included
16011229|NCT02803125|Behavioral|Support group control|The support groups will be process-oriented in nature with core elements manualized to facilitate consistency of the intervention. In particular, group leaders will facilitate a check-in with the group, and the agenda will be open to topics brought in by group members
16011230|NCT02803112|Procedure|Emergent craniotomy for traumatic brain injury|Emergent craniotomy for traumatic brain injury (either for removal of an epidural hematoma, subdural hematoma, intraparenchymal hematoma or decompressive craniectomy).
16011231|NCT02803099|Drug|Coppertone (BAY 987517)|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Number-SR15-63-Z13-084).
16011232|NCT02803073|Drug|Testosterone|Testosterone Cypionate Intramuscular injections will be administered weekly
16011233|NCT02803073|Drug|Normal Saline|Normal Saline Intramuscular injections will be administered weekly
16011234|NCT02803060|Drug|Coppertone (BAY987516)|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.(Formaulation number- SR15-62 -Z15-038).
16011235|NCT02803047|Drug|Coppertone (BAY987516)|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.(Formulation number - SR15-61-Z15-034).
16011236|NCT02803034|Drug|Coppertone (BAY987516)|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Number- SR15-60-Z15-030).
16011237|NCT02803021|Drug|Coppertone (BAY987517)|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.(Formulation Number - SR15-47-Z13-076)
16011238|NCT02803008|Drug|Coppertone (BAY987517)|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation number - SR15-46-Z13-072)
16011239|NCT02802995|Drug|PRP/thrombin mixture|Mixture of platelet rich plasma and thrombin applied topically on the wound surface
16011240|NCT02802969|Procedure|Surgery|"The operative approach and operating time will be performed according to neurosurgical practices (for head and neck) or surgical orthopaedic team (for sacrum) depending on the location, the extension and the relationship of the lesion to critical structures.
~The surgery can be macroscopically complete or incomplete."
16011241|NCT02802969|Radiation|Protontherapy|Radiotherapy will be done with the Cyclotron, for a total dose of 78 Gray Relative Biological Effective (Gy RBE) - 70 Gy RBE to the tumor bed and macroscopic volume and 8 Gy RBE to the the hypoxic component volume, delivered in 39 fractions spread over 67 days.
16011242|NCT02802969|Drug|18F FAZA|FAZA PET/CT, in order to target the hypoxic zones
16011243|NCT02802956|Other|Daily Life Promotion Program|Daily Life Promotion Program
16011244|NCT02802956|Other|general rehabilitation treatment|general rehabilitation treatment
16011245|NCT02802943|Biological|Peptide Vaccine|Individualized multi-peptide cocktail consisting of 300 μg each of 5 HLA class I and 4 HLA class II restricted peptides. The peptides for each individual patient will be selected from a warehouse consisting of 30 different peptides restricted by the 6 most common HLA class I allotypes (A*01, A*02, A*03, A*24, B*07, B*08) and 4 HLA class II peptides. Peptides will be administered subcutaneously. Vaccination will take place on d1, d4, d8, d15, d22 followed by vaccinations every 4 weeks for 1 year. The peptide warehouse is selected based on our data on the non-mutant HLA-presented antigenome of CLL identified as frequently presented CLL-associated T cell epitopes with a high potential for broad clinical application.
16011246|NCT02802943|Drug|Imiquimod|All patients will receive imiquimod (Aldara®) as local adjuvant, applied topically at the side of vaccination 18h to 24h prior to the vaccination.
16011247|NCT02802930|Drug|SPF 50 Y65 110 (BAY987519)|Application of 200 µL in an occlusive patch of Webril (0.150 ± 0.010 mg) compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.
16011248|NCT02802930|Drug|SPF 50 Y51 002 (BAY987519)|Application of 200 µL in an occlusive patch of Webril compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.
16011249|NCT02802930|Drug|SPF 15 V27 104 (BAY987519)|Application of 200 µL in an occlusive patch of Webril compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.
16011250|NCT02802930|Drug|Sodium chloride [NaCl]|Negative control (200 µL, 0.9% sodium chloride [NaCl]) after a single 24 h application of test materials followed by irradiation with ultraviolet A (UVA) and ultraviolet B (UVB).
16011251|NCT02802917|Drug|SPF 50 Y49 091 (BAY 987516)|5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.
16011252|NCT02802917|Drug|SPF 50 X15 158 (BAY 987516)|5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.
16011253|NCT02802917|Drug|SPF 50 X15 160 (BAY 987516)|5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.
16011254|NCT02802917|Drug|SPF 50 X57 162 (BAY 987516)|5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.
16011255|NCT02802917|Other|J & J baby shampoo, X46 046 (control)|5 μL of the appropriate test or control article were instilled into the lower conjunctival sac of the eye.
16011256|NCT02802904|Other|Diet: Palm olein IV64|Each subject received a palm olein-based run in diet for 2 weeks, followed by random assignment test fat Palm Olein IV64 which was incorporated into daily snacks (~50g of test fats, brownies (~15g test fat each) for breakfast and 4 pieces cookies (~5g test fat each) with low fat palm olein based background diet daily.
16011257|NCT02802904|Other|Diet: Cocoa butter|Each subject received a palm olein-based run in diet for 2 weeks, followed by random assignment test fat cocoa butter which was incorporated into daily snacks (~50g of test fats, brownies (~15g test fat each) for breakfast and 4 pieces cookies (~5g test fat each) with low fat palm olein based background diet daily.
16011258|NCT02802904|Other|Diet: Virgin olive oil|Each subject received a palm olein-based run in diet for 2 weeks, followed by random assignment test fat virgin olive oil which incorporated into daily snacks (~50g of test fats, brownies (~15g test fat each) for breakfast and 4 pieces cookies (~5g test fat each) with low fat palm olein based background diet daily.
16011259|NCT02802878|Device|Hybrid Training using Electrodes and Joint Motion Sensors|"Electrodes (Sekisui Plastics Co., Tokyo, Japan) will be placed on the anterior thigh over the motor points of the bilateral vastus medialis and lateralis, and on the posterior thigh over the motor points of the medial and lateral hamstrings. Electrical stimulation intensity will be set to approximately 40% of 1 repetition maximum (RM).
~A joint motion sensor (Mutoh Engineering Inc., Tokyo, Japan) will trigger stimulation of the antagonist once it senses the initiation of volitional contraction of the agonist muscle group."
16011260|NCT02802878|Device|Isokinetic Training with Isokinetic Dynamometer|Low intensity exercises completed using isokinetic dynamometer (HUMAC NORM, Computer Sports Medicine Inc. (CSMi), Stoughton, MA) in isokinetic mode at approximately 40%1 RM.
16011261|NCT02802865|Drug|Clomiphene|
16011262|NCT02802865|Drug|Letrozole|
16011263|NCT02802852|Device|Pneumatic calf compression|Application of a pneumatic calf compression device for two hours per day, every day for 30 days.
16011264|NCT02802852|Drug|Filgrastim|Administration of Filgrastim 10 mcg/kg every 3rd day for 30 days
16011265|NCT02802839|Device|Virtual Reality|
16011266|NCT02802826|Behavioral|Tailored Exercise Prescription|The intervention is a walking- based exercise prescription with the aim of a graduated increase in exercise to achieve national guidelines (i.e. Over 150mins of moderate intensity exercise over a week).
16011267|NCT02802813|Drug|Dihydroartemisinin-piperaquine (DP) + Primaquine (PQ)|
16011268|NCT02802813|Drug|Dihydroartemisinin-piperaquine (DP) + Primaquine (PQ) placebo|
16011269|NCT02802800|Other|Plyometric training|Plyometric exercises
16011270|NCT02802787|Other|Camp Discovery|Activities will include physical, social, emotional, sensory and spiritual activities.
16011271|NCT02802774|Other|Plaster Splint|The custom plaster splint is the historical standard. The surgical incision is dressed with non-stick gauze, 4x4 gauze pads, cotton padding, a plaster splint applied to the palmar surface of the palm and forearm, and then a cloth wrap to keep it all in place. Patients will wear the plaster splint for 2 weeks post-op.
16011272|NCT02802774|Other|Velcro Brace|The Velcro wrist brace is a commercially available over-the-counter splint which will initially be fitted over a thin layer of non-stick gauze, 4x4 gauze, and cotton padding. Patients will be asked to wear the brace as much as possible for the first 2 weeks post-op.
16011273|NCT02802774|Other|Soft Dressing|Patients in the soft dressing group will have non-stick gauze, 4X4 gauze, cotton padding, and a cloth wrap. It will be the same dressing as the custom splint without the plaster slab. Patients wear the soft dressing for the first three days post-op.
16011274|NCT02802748|Drug|Oral Vinorelbine|Metronomic Schedule of Vinorelbine administered orally in a schedule monday-wednesday-friday, tuesday-thursday-saturday, etc
16011275|NCT02802748|Drug|Letrozole|Letrozole will be administered orally at 2.5 mg QD for 3 weeks.
16011276|NCT02802735|Drug|Apremilast|Tablet for oral administration
16011277|NCT02802735|Drug|Placebo|Tablet for oral administration
16011278|NCT02802722|Dietary Supplement|Vitamin D3 supplementation|Capsules to be dispensed using an electronic dispenser to allow real time logging of adherence.
16011279|NCT02802722|Biological|Peripheral blood and induced sputum sampling|To attain samples for immunological testing
16011280|NCT02802722|Radiation|Chest computerised tomography (CT) scans|For volumetric quantification of lung abnormalities
16011281|NCT02802722|Other|Symptom questionnaire|Symptom questionnaire for recent symptom history
16011282|NCT02802722|Other|Placebo|To be dispensed using an electronic dispenser to allow real time logging of adherence.
16011283|NCT02802709|Device|SB-061|delivered via intra-articular injection
16011284|NCT02802709|Other|Placebo|Placebo
16011285|NCT02802696|Drug|Furosemide|A bolus dose of 20mg furosemide (20mg/2mL) will be given intravenously by slow intravenous push within 60 minutes prior to the start of the red blood cell transfusion; infusion via minibag is also acceptable.
16011286|NCT02802696|Drug|Normal Saline|A single bolus dose of 2 mL normal saline will be given intravenously immediately within 60 minutes prior to the start of the red blood cell transfusion; infusion via minibag is also acceptable.
16011287|NCT02802683|Drug|Bupivacaine|spinal anesthesia with hyperbaric bupivacaine
16011288|NCT02802683|Drug|Levobupivacaine|spinal anesthesia with isobaric levobupivacaine
16011289|NCT02802683|Drug|Phenylephrine|continous infusion of phenylephrine
16011290|NCT02802683|Drug|normal saline|continous infusion of normal saline
16011291|NCT02802670|Drug|[14C]-GDC-0810|Participants will receive a single 300-mg dose of GDC-0810 containing approximately 100 microcuries of [14C]-labeled GDC-0810 on Day 1.
16011292|NCT02802657|Procedure|Treat-and-Extend regimen|For the T&E regimen,investigators recorded patients' data after retreatment by 3 monthly intravitreal injections of Conbercept. Patients were examined 6 weeks after the third injection, with ETDRS visual acuity testing, fundus ophthalmoscopy and photography, and OCT, and treated on the same day. The interval between treatments was extended by 2-week (12-week was a maximum) provided that OCT and fundus examination did not show either exudative manifestations or new macular hemorrhage or active CNV or reduced by 2 weeks (4-week was minimum) in case of such manifestations or hemorrhage. The persistence of pigment epithelium detachment was not considered a condition that justified shortening the interval between injections.
16011293|NCT02802657|Procedure|Pro Re Nata|For the PRN group, investigators recorded patients'data after retreatment by 3 monthly intravitreal injections of Conbercept.Subsequent reinjections were given as needed according to the changes in patients'visual acuity and/or the exudation shown by OCT. Four to five weeks after the third and last injection, all patients in the PRN group underwent an examination, including ETDRS visual acuity, fundus photography,and OCT. In case of persistent subfoveal or perifoveal fluid, macular intraretinal edema, visual loss of >5 letters, or the occurrence of a new hemorrhage, patients were retreated. The persistence of hemorrhage without evidence of fluid was not considered a criterion for retreatment. In the absence of retreatment criteria, no further injections were given and another examination was proposed usually 4 weeks later.
16011294|NCT02802657|Drug|Conbercept|
16011295|NCT02802644|Drug|Sitagliptin|Sitagliptin is indicated to control hyperglycemia in type 2 diabetic patients.
16011296|NCT02802644|Drug|Non DPP-4 Inhibitor|This group patients is permitted to take any other oral anti-hyperglycemic agents except sitagliptin.
16011297|NCT02802631|Drug|Minocin (minocycline) for Injection|Intravenous formulation of minocycline, a derivative of tetracycline
16011298|NCT02802631|Other|Placebo|Placebo - Normal Saline
16011299|NCT02802618|Other|Interactive 3D visualization technique|The pulmonary rehabilitation consists of exercise training during two times/week for 10 weeks and a theoretic part presented with 3D visualization technique.
16011300|NCT02802605|Drug|Bemiparin|Bemiparin subcutaneus administration
16011301|NCT02802592|Drug|Epogen|1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm
16011302|NCT02802592|Drug|Normal Saline|1:1 randomization to either the Epogen arm or Placebo(Normal Saline) arm
16011303|NCT02802579|Radiation|standard protocol|tube voltage: 120 kV current time product: 350 mAs/rotation rotation: 90° (with two detectors in a 90° angle)
16011304|NCT02802579|Radiation|enhanced protocol|tube voltage: 140 kV current time product: 350 mAs/rotation rotation: 90° (with two detectors in a 90° angle)
16011305|NCT02802579|Radiation|enhanced obesity protocol|tube voltage: 140 kV current time product: 350 mAs/rotation rotation: 180° (with two detectors in a 90° angle)
16011306|NCT02802566|Dietary Supplement|BMI-based prenatal vitamin|The intervention group receives additional antioxidant micronutrients that we have found to be decreased in obese pregnant women.
16011307|NCT02802566|Dietary Supplement|Standard prenatal vitamin|Standard prenatal vitamin
16011439|NCT02801591|Procedure|Conventional ovarian stimulation proctol without rhGH|
16011308|NCT02802553|Device|Smart Goggle|Smart Goggle is a novel stereoscopic wearable multimodal intraoperative imaging and display systems entitled Integrated Imaging Goggles for assessment of SLNs. The prototype system offers real time stereoscopic fluorescence imaging along with in vivo handheld microscopy. The investigators have found that the system can detect fluorescent targets with as low as 1.2 picomoles ICG (60 nM concentration). The hand-held microscopy module has a resolution of 25 micron. The prototype system has 2 complementary metal-oxide-semiconductor (CMOS) imaging sensors housed on a printed circuit board (PCB) with imaging lenses and emission filters optimized for ICG dye. The light source provides concurrent excitation centered at 780 nm and white light illumination with OD6 level cut-off. The Smart Goggles is a non-invasive imaging system that does not require contact with patients.
16011309|NCT02802553|Other|Cardio-Green|Indocyanine Green for Injection USP is a sterile, lyophilized green powder containing 25 mg of indocyanine green with no more than 5% sodium iodide. Indocyanine Green for Injection USP is dissolved using Sterile Water for Injection, and is to be administered intravenously.
16011310|NCT02802553|Device|SPY Elite Imaging system|Previously validated fluorescence detection system. Will be used to look at the same regions as the Smart Goggles to confirm sensitivity
16011311|NCT02802553|Device|Quest near-infrared (NIR) Imaging system|Previously validated fluorescence detection system. Will be used to look at the same regions as the Smart Goggles to confirm sensitivity
16011312|NCT02802553|Device|PDE Imaging system|Previously validated fluorescence detection system. Will be used to look at the same regions as the Smart Goggles to confirm sensitivity
16011313|NCT02802553|Device|Gamma probe|Gold standard for fluorescence detection. The gamma probe and blue dyes will be used in conjunction to confirm presence of Sentinel Lymph Nodes (SLNs). The gamma probe provides non-imaging sensing data and the blue dyes provide visual signs for detection of SLNs.
16011314|NCT02802553|Other|Blue Dyes|Gold standard for fluorescence detection. The gamma probe and blue dyes will be used in conjunction to confirm presence of Sentinel Lymph Nodes (SLNs). The gamma probe provides non-imaging sensing data and the blue dyes provide visual signs for detection of SLNs.
16011315|NCT02802540|Drug|Nabilone|Patients going to take 0.5 mg capsules of nabilone (CESAMET) the first 2 weeks and then increased to 1 mg to complete 8 weeks.
16011316|NCT02802540|Drug|Placebo|Patients going to take capsules of placebo until complete 8 weeks.
16011317|NCT02802527|Procedure|Percutaneous Tracheostomy|
16011318|NCT02802514|Drug|Albiglutide 50mg|It is provided as a single use fixed dose disposable pen injector (0.5 mL) system for SC delivery. A 50 mg pen contains 67 mg lyophilized albiglutide and 0.65 mL diluents. It will be injected subcutaneously (SC) in the upper arm.
16011319|NCT02802514|Drug|Albiglutide matching placebo|It is provided as a single use fixed dose disposable pen injector (0.5 mL) system for SC delivery. It will be injected subcutaneously (SC) in the upper arm
16011320|NCT02802514|Drug|Exenatide 10microgram|It is provided as a sterile solution containing 250 microgram/mL exenatide. One dose of 10 microgram is equivalent to 0.04 ml. It will be injected subcutaneously (SC) in the upper arm
16011321|NCT02802514|Drug|Exenatide placebo (saline)|It is provided as a sterile saline. It will be injected subcutaneously (SC) in the upper arm
16011322|NCT02802501|Drug|Tafenoquine|This intervention is provided as tablet containing 150 mg of tafenoquine. Two tablets of this formulation will be administered orally with water as a single dose after a meal. Dose will be taken at least 3 hours after DHA-PQP.
16011323|NCT02802501|Drug|Matched-Placebo for Tafenoquine|This intervention contains tafenoquine matched-placebo. Two tablets of this formulation will be administered orally with water as a single dose after a meal. Dose will be taken at least 3 hours after DHA-PQP.
16011324|NCT02802501|Drug|Primaquine|This intervention is provided as over-encapsulated tablet containing 15 mg of primaquine. One capsule of this formulation will be administered orally with water as a single dose after a meal for 14 days. Dose will be taken at least 3 hours after DHA-PQP (Days 1, 2 and 3).
16011325|NCT02802501|Drug|Matched-Placebo for Primaquine|This intervention contains primaquine matched-placebo. One capsule of this formulation will be administered orally with water as a single dose after a meal for 14 days. Dose will be taken at least 3 hours after DHA-PQP (Days 1, 2 and 3).
16011326|NCT02802501|Drug|Dihydroartemisinin-piperaquine (DHA-PQP)|This formulation is provided as tablet containing 320 mg of piperaquine tetrasphosphate (as the tetrahydrate; PQP) and 40 mg dihydroartemisinin (DHA). This tablet will be administered orally as single dose for 3 days. For subjects weighing <75 kg, 3 tablets will be administered per day. For subjects weighing >=75 kg, 4 tablets will be administered per day. Dose will be taken at least 3 hours after last food intake. No food will be allowed for at least 3 hours after dosing.
16011327|NCT02802501|Drug|ACT plus PQ (Rescue medication)|Subjects with relapse during the 180 day follow up period will be given an ACT plus PQ 0.5 mg/kg for 14 days as rescue medication.
16011328|NCT02802501|Drug|PQ (End of study treatment)|Subjects who do not relapse during the study will receive PQ 0.5mg/kg for 14 days at the end of the study.
16011329|NCT02802488|Procedure|Blood sampling|"A blood sampling will be performed in patients diagnosed with atrial fibrillation in order to test if having a D-dimers value superior or equal to the patient's age is predictive of a thrombus.
~Thombus will be diagnosed according to the standard of care."
16011330|NCT02802475|Biological|vena punction|
16011331|NCT02802462|Behavioral|HIT|3-minute intervals at 40% and 80%VO 2max
16011332|NCT02802462|Behavioral|MCT|sustained 60%VO 2max
16011333|NCT02802449|Drug|25 Hydroxy- Vitamin D3 [25 (OH) D3]|Two 50,000 IU tablets of oral Vitamin D3 [also known as cholecalciferol or 25 hydroxy-Vitamin D3 or 25 (OH) D3] will be given at baseline and 2 weeks after the baseline visit under direct observation by the nurse or research coordinator.
16011334|NCT02802449|Drug|Placebo|
16011335|NCT02802436|Procedure|Extraction with socket graft|Extraction will be done as usual standard of care to preserve socket walls. Sockets will be measured at all 4 line angles for depth with the same periodontal probe, Buccal-Lingual dimension will be measured prior to graft placement. Graft material (mineralized cortical/cancellous Bone Powder 250-1000µ) will be used for both sites. Volume of graft used will be recorded. Both sites will be filled slightly below marginal bone level (1mm). Test site will be injected with Bioactive Agent. At 3 levels apical 1/3rd, middle 1/3rd and coronal 1/3rd. Control site will be injected with saline (or vehicle) at same levels. Occlusal orifice will be closed with Collagen plug adjusted for depth to meet free gingival margins and then sutured with 4-0 PGA (Vicryl)
16071170|NCT02374567|Drug|Nicergoline|
16011336|NCT02802423|Drug|BLEX 404 Oral Liquid|BLEX 404 Oral Liquid is administered twice daily during the Docetaxel monotherapy period. The dose of Docetaxel is 75 mg/m2 IV, 21 days a cycle.
16011337|NCT02802410|Device|IQ-Tape|RMS-values of leg muscles at pre-activation (50ms) before ground-contact and post-activation 0-30ms and 30 - 150ms after ground-contact during drop-jump, running and stair climbing.
16011338|NCT02802410|Device|Kinesiotape|RMS-values of leg muscles at pre-activation (50ms) before ground-contact and post-activation 0-30ms and 30 - 150ms after ground-contact during drop-jump, running and stair climbing.
16011339|NCT02802410|Other|No-Tape|RMS-values of leg muscles at pre-activation (50ms) before ground-contact and post-activation 0-30ms and 30 - 150ms after ground-contact during drop-jump, running and stair climbing.
16011340|NCT02802397|Other|Self-administered questionnaire and blood and urine samples|Self-administered questionnaire and blood and urine samples
16011341|NCT02802371|Behavioral|Psychosocial intervention|Caregivers included in this group will benefit from a multi-component intervention with three collective sessions and individual interview in face-to-face or by phone according to the follow-up time.
16011342|NCT02802371|Other|Pharmaceutical care and psychosocial support|"Caregivers included in this group will benefit from the same multi-component intervention that group psychosocial intervention with the integration of pharmaceutical care by a clinical pharmacist. The clinical pharmacist will intervene in: 1) the pharmaceutical need assessment of the caregivers considering their medication management and the medication management of their relatives at the inclusion; 2) a collective session on medication management; and 3) personalized interviews to consider needs, medication problems and difficulties in the therapeutic optimization process."
16011343|NCT02802358|Procedure|Surgery or non-invasive procedure (reduction of the fracture, immobilization, stabilization)|
16011344|NCT02802345|Drug|Nintedanib|
16011345|NCT02802345|Drug|Placebo|
16011346|NCT02802345|Drug|Sildenafil|
16011347|NCT02802332|Behavioral|Footlength Card|The footlength card has an image of a baby's foot. The card is to be held up against the baby's foot after birth; if a baby's foot is smaller than the image, or if the woman/family member is concerned about the health of their baby, they can call the number printed on the card and hear a pre-recorded message about basic care for newborn babies
16011348|NCT02802319|Device|Porcine Xenograft (Zcore)|Ridge preservation bone grafting after tooth extraction
16011349|NCT02802319|Device|Bovine Xenograft (Bio-Oss)|Ridge preservation bone grafting after tooth extraction
16011350|NCT02802306|Device|Tack Endovascular System|Repair of post-PTA dissections using the Intact Vascular Tack Endovascular System
16011351|NCT02802293|Device|repetitive transcranial magnetic stimulation|The MagPro R30 is an advanced, high performance magnetic stimulator designed primarily for non-invasive clinical use. The non-invasive brain stimulation system will be used to deliver repetitive electromagnetic pulses in this research study's treatment of major depressive disorder.
16011352|NCT02802293|Device|robotic arm|This robotic system is based on a commercially available neurosurgical robot. The robot is mounted on a mobile (i.e. retractable wheels) cart which holds the robot controller and the TMS power supply and pulse-generation computer. The robotic system will be used for TMS coil positioning/targeting.
16011353|NCT02802280|Other|Cardiovascular risk in HCV patients|"Cardiovascular risk assessement (through Flow-mediated vasodilatation FMV, measurement of endothelial function biomarkers, carotid ultrasound, etc.)
~This is a prospective study. The only intervention planned will consist of performing different tests that define the individual cardiovascular risk. These tests will be carried out on a single group cohort at different times.
~Notwithstanding, the investigators will record the exposure to DAA to assess any change in CVR.
~Anti-HCV regimens will be used according to clinical practice as indicated into the current guidelines (1)
~(1)European Association for Study of Liver. EASL Recommendations on Treatment of Hepatitis C 2015. J Hepatol. 2015 Jul;63(1):199-236. doi: 10.1016/j.jhep.2015.03.025. Epub 2015 Apr 21. PubMed PMID: 25911336."
16011354|NCT02802267|Drug|Inecalcitol|vitamin D receptor agonist
16011355|NCT02802267|Drug|Placebo Oral Tablet|placebo
16011356|NCT02802254|Behavioral|Patient-targeted individual physical-activity-feedback|At cardiac consultation receive an individual feedback on their personal physical activity level.
16011357|NCT02802254|Device|Pedometer|Patients receive a pedometer two weeks prior to cardiac consultation.
16011358|NCT02802241|Drug|placebo|
16011359|NCT02802241|Dietary Supplement|peppermint oil|
16011360|NCT02802228|Drug|Ifetroban|thromboxane prostanoid receptor antagonist delivered as infusion and oral capsule
16011361|NCT02802228|Drug|Placebo|matched placebo delivered as infusion and oral capsule
16011362|NCT02802215|Drug|metformin|Metformin group will receive 1500 mg of metformin per day orally ( 500 mg every 8hrs in the middle of meal) starting from 12th week of gestation till delivery.
16011363|NCT02802215|Drug|placebo (folic acid )|500 micro gram of folic acid every 8 hrs
16011364|NCT02802189|Other|Exercise programme|"Endurance and Resistant training exercise program (Duration: 45 minutes)
~Muscle retraining of longus colli and endurance training of the deep cervical flexors.
~Resistant exercises for the muscles involved in neck flexion, extension, side bending and rotation of the neck region. Isometric contractions exercises (20-70% of MVC) and resistant exercises (12-15RM).
~Active ROM exercises for the neck muscles
~Upper limbs exercises with resistant bands
~Stretching exercises for the neck and upper limbs muscles"
16011365|NCT02802189|Other|Integrated Neuromuscular Inhibition Technique application.|"Integrated Neuromuscular Inhibition Technique application.
~(Duration: 15min)
~The protocol was applied to the following muscles:
~Upper border of the trapezius muscle
~sternocleidomastoid
~levator scapulae muscle
~splenius capitis muscle
~Integrated Neuromuscular Inhibition Technique includes the combination of the following technique:
~Ischemic compression
~Muscle energy technique
~Strain-counterstrain technique"
16011366|NCT02802176|Device|INVOcell device|intra-vaginal culture of embryos using INVOcell device
16011367|NCT02802176|Other|Traditional IVF|traditional culture of embryos in-vitro
16011368|NCT02802163|Drug|Panobinostat|"Induction Phase: Panobinostat (dose escalation beginning at 10 mg) will be administered 3 times a week (TIW) by mouth every other week starting on day 1 of each cycle.
~Maintenance Phase: Panobinostat will be administered TIW by mouth every other week starting on day 1 of each cycle. The dose of panobinostat during maintenance phase will be the same dose taken during cyce 8 of induction phase."
16011747|NCT02799147|Drug|Fludarabine monophosphate|
16011369|NCT02802163|Drug|Carfilzomib|Induction Phase: Carfilzomib will be administered at 20 mg/m^2 on Cycle 1 Day 1. Beginning on Cycle 1 Day 2 the carfilzomib dose will be according to the assigned level of 27 mg/m^2 or 36 mg/m^2. Carfilzomib will be administered twice weekly IV on Days 1,2, 8,9,15, and 16.
16011370|NCT02802163|Drug|Lenalidomide|"Induction Phase: Lenalidomide (25 mg) will be administered once-daily by mouth on Days 1-21, 25.
~Maintenance Phase: Lenalidomide (10 mg) will be administered once-daily by mouth on days 1-21."
16011371|NCT02802163|Drug|Dexamethasone|Induction Phase: Dexamethasone (20 mg) will be administered twice weekly by mouth or by IV on Days 1,2, 8, 9, 15, and 16.
16011372|NCT02802150|Dietary Supplement|Zanthoxylum Schinifolium Seed Oil(4g/day)|parallel design
16011373|NCT02802150|Dietary Supplement|Soy Bean Oil;placebo(4g/day)|parallel design
16011374|NCT02802137|Drug|tafluprost|
16011375|NCT02802137|Drug|tafluprost and dorzolamide/timolol|
16011376|NCT02802124|Radiation|carbon-ion radiotherapy for tumor away from GI|
16011377|NCT02802124|Radiation|carbon-ion radiotherapy for tumor adjacent to GI|
16011378|NCT02802111|Drug|Albuterol|Patient receives albuterol 5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention.
16011379|NCT02802111|Drug|Levalbuterol|Patient receives levalbuterol 2.5 mg aerosolized. Oxygen consumption and vital signs are measured for 1 hour after intervention
16011380|NCT02802098|Drug|Durvalumab|Durvalumab is an investigational human monoclonal antibody directed against programmed death ligand-1 (PD-L1). PD-L1 can be expressed by tumours to evade detection by the immune system through binding to PD-1 on cytotoxic T lymphocytes. Durvalumab blocks the PD-L1 interaction with PD-1, countering the tumour's immune-evading tactics.
16011381|NCT02802098|Drug|Bevacizumab|Bevacizumab is a recombinant humanized monoclonal antibody that blocks angiogenesis by inhibiting vascular endothelial growth factor A (VEGF-A)
16011382|NCT02802085|Device|VEGA Knee|TKA
16011383|NCT02802072|Device|Enterprise stent implantation|Enterprise stent system (Johnson & Johnson (Shanghai) Medical Equipment Co.,Ltd., China) is a closed loop self-expanding stent system that is made of Ni-Ti alloy. It consists of a self-expanding stent and a delivery system.
16011384|NCT02802072|Drug|Only aspirin medication|Only aspirin medication will be conducted, initial dose is 300 mg/d, 200 mg/d 6 months later, and 100 mg/d 1 year later.
16011385|NCT02802059|Drug|EcN-Suspension|"Initial administration not later than 120h after birth. 14 ampoules a 1 ml are administered within a time of 3 weeks (1 ampoule per day within first week and 1 ampoule every second day within the following two weeks).
~Subsequent re-administration after 6 and 12 months. 10 ampoules a 1 ml are administered within 10 days (1 ampoule per day)."
16011386|NCT02802059|Drug|Placebo|"Initial administration not later than 120h after birth. 14 ampoules a 1 ml are administered within a time of 3 weeks (1 ampoule per day within first week and 1 ampoule every second day within the following two weeks).
~Subsequent re-administration after 6 and 12 months. 10 ampoules a 1 ml are administered within 10 days (1 ampoule per day)."
16011387|NCT02802046|Radiation|Computed tomographic angiography of coronary artery|
16011388|NCT02802020|Device|Pancreatic fully-covered self-expanding metal stent (FCSEMS)|The WallFlex™ Pancreatic RX Fully Covered Soft Stent System consists of a flexible delivery system preloaded with a self-expanding pancreatic metal stent.
16011389|NCT02802007|Device|Elipse Intragastric Balloon|
16011390|NCT02801994|Device|PAV, Puritan Bennett 980 ventilator|The PAV mode will be delivered by Puritan Bennett 980 ventilator (Covidien, Boulder, USA). Levels of PEEP and FiO2 will be kept constant. The level of assistance in PAV, named %-assistance will be set in order to keep the patient in a respiratory effort zone corresponding to a respiratory muscles pressure time product (PTPmus) between 50 and 150 cm H2O • s / min. As it is not possible to calculate directly the PTPmus at bedside, the investigators will use as a substitute its main component, the pressure peak muscle of the airways according to the previous report from Carteaux et al. This setting has been described extensively and its use has been the subject of a feasibility study in 50 patients. After a 20-minutes stabilization period, a 30-minutes recording will be performed.
16011391|NCT02801981|Drug|GSK2230672|It will be supplied as white to slightly colored, round, film coated tablet for oral administration containing 10 mg or 45 mg of GSK2330672.
16011392|NCT02801981|Drug|Placebo|It will be supplied as placebo tablets (with no GSK2230672) visually matching to GSK2230672
16011393|NCT02801968|Procedure|Tap block|
16011394|NCT02801968|Other|intravenous analgesia|
16011395|NCT02801955|Procedure|gastrectomy|radical total/subtotal gastrectomy with D2 lymph node dissection
16011396|NCT02801955|Procedure|sampling of peritoneal washing aspirate|After thoroughly examination of the peritoneal cavity revealing the absence of peritoneal dissemination, the peritoneal cavity was washed with 200 ml of saline, and at least one third was aspirated from several regions of the peritoneal cavity, including near the primary tumor, the left and right subphrenic areas and the pouch of Douglas with suction tubes to a clean bottle and designated as the peritoneal sample for determination of peritoneal levels of CEA and CA 19-9.
16011397|NCT02801942|Procedure|Inguinal lymph node fine needle aspirate biopsy|Inguinal lymph node will be localized by ultrasonography and sampled by 21-gauge needle and a 5 mL syringe using to and fro needle movement while applying 1 mL suction with the syringe. Up to 2 fine needle aspirate passages will be obtained, to derive immune cells.
16011398|NCT02801942|Procedure|Inguinal lymph node core biopsy|Inguinal lymph node will be localized by ultrasonography and following fine needle aspirate, an incision will be made. Up to five core biopsies will be obtained, to derive immune cells.
16011399|NCT02801942|Procedure|Peripheral blood collection|Blood sample (30 mL) will be collected, to derive immune cells.
16011400|NCT02801942|Other|Pre- and post-biopsy questionnaire|All subjects will be asked to complete a questionnaire about their expectations/experiences of undergoing the biopsy procedures.
16011401|NCT02801929|Drug|Coppertone (BAY987518)|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Number - SR15-72_V27-010).
16011402|NCT02801916|Other|0 grams oat bran|200 milliliters water plus 0 grams OatWell22, a commercial oat bran product containing 22% oat beta-glucan, followed by 119 grams white bread
16011403|NCT02801916|Other|4.5 grams oat bran|200 milliliters water plus 4.5 grams OatWell22, a commercial oat bran product containing 22% oat beta-glucan, followed by 119 grams white bread
16011748|NCT02799147|Drug|Busulfan|
16011404|NCT02801916|Other|13.6 grams oat bran|200 milliliters water plus 13.6 grams OatWell22, a commercial oat bran product containing 22% oat beta-glucan, followed by 119 grams white bread
16011405|NCT02801916|Other|27.3 grams oat bran|200 milliliters water plus 27.3 grams OatWell22, a commercial oat bran product containing 22% oat beta-glucan, followed by 119 grams white bread
16011406|NCT02801903|Drug|SB204 4%|Topically Once Daily (AM)
16011407|NCT02801890|Biological|Intravenous injection|Intravenous injection of stem cell or placebo to the patients with The patients with ultra filtration failure (UFF) .
16011408|NCT02801877|Behavioral|IntelliCare|
16011409|NCT02801877|Behavioral|Hub App with the Recommender System|
16011410|NCT02801877|Behavioral|Coaching|
16011411|NCT02801864|Device|Real tDCS|Participants will receive tDCS at 1mA for 20min of the total three hours of intensive speech therapy time at the beginning of each session. Stimulation will be provided via an electrode using a Starstim device.
16011412|NCT02801864|Device|Sham tDCS|Participants will receive tDCS at 1mA for 20min of the total three hours of intensive speech therapy time at the beginning of each session. Stimulation will be provided via an electrode using a Starstim device.
16011413|NCT02801864|Other|Intensive Speech Therapy|Participants will receive one hour of group therapy and two hours of individual therapy that will follow VNeST format. The purpose of therapy will be to have the client generate verbs and nouns in written and verbal form.
16011414|NCT02801851|Behavioral|SCREEN-ED|SCREEN-ED will have 4 key components: systematic screening for delirium using the CAM; informing providers of the screening result; a checklist protocol for initial delirium management based on clinical guidelines tailored to the ED, which includes identification of cause, risk factor modification, and behavioral interventions; documentation in the Electronic Health Record (EHR) and communication with inpatient providers of delirium screening results.
16011415|NCT02801838|Drug|Morphine|If the physician in charge of the patients judges it necessary, after the optimization of the ventilators settings, if the patient remains uncomfortable, a second therapeutic intervention using a maximum of 10mg morphine titration may be performed. After this second therapeutic intervention, a third non-verbal measure of respiratory discomfort will be performed with the IC-RDOS. Concomitantly, EEG and EMG will be again recorded over a of 15-minutes period.
16011416|NCT02801825|Procedure|Real-time ultrasound-guided in-plane infraclavicular axillary artery cannulation.|Real-time ultrasound-guided in-plane infraclavicular axillary artery cannulation.
16011417|NCT02801825|Procedure|Real-time ultrasound-guided out-of-plane femoral artery cannulation.|Real-time ultrasound-guided out-of-plane femoral artery cannulation.
16011418|NCT02801812|Device|nailfold capillaroscopy|Detection by nailfold capillaroscopy of capillary abnormalities in patients with Systemic Lupus Erythematosus and comparison with healthy controls at enrolment
16011419|NCT02801799|Drug|Varying infusion rates of Ropivacaine 0.2%|"Participants will receive one nerve catheter adjacent to the common peroneal nerve (trial day 1) and adjacent to the sciatic nerve (trial day 2). Each catheter will be randomly allocated to one of five infusion groups. All peroneal nerve catheters will receive the same volume of ropivacaine 0.2%. All the sciatic nerve catheters will receive the same volume of ropivacaine 0.2%.
~The only inter-group variable will be the infusion rate. The fixed volume of ropivacaine will be determined in a separate study ('The Volume Study'), which is also part of the project: 'A novel technique for reliable, precise and safe postoperative management'.
~The largest volumes tested in The Volume Study are 30 mL for the sciatic nerve and 20 mL for the common peroneal nerve. Therefore the highest volume for the two intervention days cannot exceed 30 mL (150 mg of ropivacaine).
~We will ensure constant infusion rate and precise delivery of LA by using an electronic infusion pump and a nerve catheter."
16011420|NCT02801786|Drug|Placebo|The arm will be composed of 03 women who used placebo capsules and gel.
16011421|NCT02801786|Drug|Lidocaine|The arm 2 will consist of women who used the placebo capsules for 5 days and 4% lidocaine gel 15 minutes before the test.
16011422|NCT02801786|Drug|Tamoxifen|The arm 01 is composed of patients who use tamoxifen 20mg one capsule per day for 05 days before the test and placebo gel 15 minutes before the exam.
16011423|NCT02801773|Dietary Supplement|Treatment Gingivitis with Probiotic|Gingivitis Treatment (scaling and coronary polish) and one lozenge containing Lactobacillus reuteri per day during 3 months
16011424|NCT02801773|Other|Treatment Gingivitis conventional|gingivis treatment (scaling and coronary polish) and and one lozenge containing Placebo (mint lozenge) per day during 3 months
16011425|NCT02801747|Behavioral|Heart to Heart2 (HTH2)|The present study uses a fractional factorial design to evaluate the efficacy of five distinct culturally appropriate intervention components on the primary outcome, HIV viral suppression.
16011426|NCT02801734|Other|EQUIP|Patients in the EQUIP intervention group will receive four face-to-face sessions. The focus of these sessions is to equip patients with the skills and strategies needed to cope with common symptoms experienced by lung cancer patients.
16011427|NCT02801721|Other|psycho social stimulation|The psychosocial intervention lasted for 9 months and included play demonstrations at home by a play leader (PL) who was trained to visit homes and teach the mothers about child development and care practices. They also showed the mothers how to play with children using toys in a way to promote good child development. In the original study all anemic children in early childhood received 30 mg ferrous sulphate daily based on recommendations from both the WHO (2003) and IOM reports (2001) for 6 months.
16011428|NCT02801695|Drug|Citrulline|Citrulline supplementation
16011429|NCT02801695|Drug|Placebo|Placebo
16011430|NCT02801669|Drug|Du-176b|DU-176b orally administered at a dose of 15 mg once daily.
16011431|NCT02801669|Drug|placebo|Placebo orally administered once daily.
16011432|NCT02801656|Biological|Fecal Microbiota Transplantation|Oral, encapsulated FMT
16011433|NCT02801656|Drug|Vancomycin|Vancomycin po 125 mg qid x 10 days
16011434|NCT02801656|Biological|Fecal Microbiota Transplantation Placebo|Matching placebo to FMT
16011435|NCT02801656|Drug|Vancomycin Placebo|Matching placebo to Vancomycin
16011436|NCT02801630|Device|PainShield SAW Patch Device|The PainShield is a self contained Surface Acoustic Wave device, where the waves are delivered locally through a trasnducer embedded into a patch that sits on the affected area.
16011437|NCT02801617|Drug|PRO-067|1 drop QD during 30 days is a sterile ophthalmic solution formulated by Laboratorios Sophia S.A. de C.V.
16011438|NCT02801617|Drug|GAAP Ofteno®|1 drop QD during 30 days Active comparator, reference medication.
16011440|NCT02801578|Drug|Ibrutinib|Cycle 1 daily dose of ibrutinib is 420 mg (3 capsules), in the second cycle 280 mg (2 capsules), and in the third cycle 140 mg (1 capsule).
16011441|NCT02801565|Drug|Conventional controlled ovarian stimulation proctol|Conventional controlled ovarian stimulation proctol without rhGH.
16011442|NCT02801552|Device|PRF|Regenerative Endodontic Procedure with PRF: autologous PRF will be used instead of blood clot in the second vist.
16011443|NCT02801539|Device|RMT therapy using modified RMT device|The exercises provided by the RMT device is intended to strengthen breathing muscles.
16011444|NCT02801539|Device|Sham-RMT therapy using modified RMT device|The exercises provided by the Sham-RMT modified device is not intended to strengthen breathing muscles.
16011445|NCT02801526|Drug|CKD-330 16/5mg - A|
16011446|NCT02801526|Drug|Candesartan 16mg and Amlodipine 5mg|
16011447|NCT02801513|Behavioral|Brief Mindfulness Training|Brief mindfulness training comprising of three weekly individual sessions and daily guided meditation home practice
16011448|NCT02801513|Behavioral|Resting Control Training|Brief resting control training comprising of three weekly individual sessions and daily home practice consisting of resting periods
16011449|NCT02801500|Device|Magnetic Compressive Anastomosis|The magnetic compressive anastomosis device will be used to complete the anastomosis during bilioenteric anastomosis.
16011450|NCT02801500|Procedure|Manual Anastomosis|A handsewn technique will be used to complete the anastomosis during bilioenteric anastomosis.
16011451|NCT02801487|Radiation|Carbon ion radiotherapy (CIRT)|Five dose levels (52.5GyE, 55GyE, 57.5GyE, 60GyE, 62.5GyE) are planned within the Phase I part. Daily fraction of 2.5 GyE will be delivered for all dose levels. After the recommended dose (RD), i.e., MTD, is determined or if the treatments to 62.5 GyE are safely delivered, the recommended dose (or 62.5 GyE) will be the prescribed dose in the Phase II part of the study. Ninety-five percent (95%) of the isodose line should cover the GTV+3~5mm.
16011452|NCT02801487|Drug|Cisplatin|Cisplatin (40mg/m^2) monotherapy will be given weekly along with radiotherapy.
16011453|NCT02801474|Procedure|direct fracture reduction and fixation|In the DR group, the posterior malleolar fracture was reduced and fixed in a direct way via a posterolateral approach with the patients in prone position.
16011454|NCT02801474|Procedure|indirect fracture reduction and fixation|In the IR group, the posterior malleolus was reduced through ligamentotaxis following open reduction and internal fixation of lateral and medial malleolar fractures. Percutaneous cannulated screws were used to fix the posterior malleolar in anterior-to-posterior direction.
16011455|NCT02801461|Device|extracorporeal shock wave therapy|Shock waves are defined a sequence of acoustic pulse characterized by a high peak pressure (100 MPa), fast pressure rise (< 10 ns) and short duration (10 μs).
16011456|NCT02801448|Drug|sulforaphane|sulforaphane-containing broccoli sprout extracts
16011457|NCT02801448|Drug|Placebo|Maltodextrine-based placebo without sulforaphane
16011458|NCT02801435|Drug|0.5% Icotinib hydrochloride cream|Topical administration for twice daily
16011459|NCT02801435|Drug|1.0% Icotinib hydrochloride cream|Topical administration for twice daily
16011460|NCT02801435|Drug|2.0% Icotinib hydrochloride cream|Topical administration for twice daily
16011461|NCT02801435|Drug|4.0% Icotinib hydrochloride cream|Topical administration for twice daily
16011462|NCT02801435|Drug|Placebo|Topical administration for twice daily
16011463|NCT02801422|Other|fMRI|
16011464|NCT02801409|Drug|General anesthesia alone|General anesthesia is performed during surgery; patient-controlled intravenous analgesia is provided after surgery.
16011465|NCT02801409|Drug|Combined epidural-general anesthesia|Combined epidural-general anesthesia is performed during surgery; patient-controlled epidural analgesia is provided after surgery.
16011466|NCT02801396|Device|Etafilcon A Design 1 (Test 1)|
16011467|NCT02801396|Device|Etafilcon A Design 2 (Test 2)|
16011468|NCT02801396|Device|Etafilcon A (Control)|
16011469|NCT02801383|Drug|Yallaferon®， the recombinant human interferon α-2b gel|
16011470|NCT02801383|Other|gel without active ingredient|
16011471|NCT02801370|Drug|12 mg ciprofloxacin|Single administration of OTO-201
16011472|NCT02801370|Drug|Sham Control|Simulated, single adminstration
16011473|NCT02801357|Drug|lofexidine administration in subjects seeking buprenorphine dose reduction|
16011474|NCT02801344|Dietary Supplement|Normal|test drink which contains low amount of amino acids (0.14 g/kg/day)
16011475|NCT02801344|Dietary Supplement|Moderate|test drink which contains moderate amount of amino acids (0.40 g/kg/day)
16011476|NCT02801344|Dietary Supplement|High|test drink which contains high amount of amino acids (1.03 g/kg/day)
16011477|NCT02801344|Other|Controlled-diet|the diet containing 0.8 g protein /kg/day
16011478|NCT02801331|Device|Stochastic Vibrotactile Stimulation (SVS)|Infant crib mattress will be replaced with a specially constructed mattress (non-commercially available) to provide gentle vibrations and sounds during mattress stimulations.
16011479|NCT02801318|Procedure|Polysomnography|
16011480|NCT02801305|Drug|Diltiazem Gel 2%|This a topical agent which will be applied on digital ulcers by scleroderma patients.
16011481|NCT02801305|Drug|Nitroglycerin Ointment 2%|This a topical agent which will be applied on digital ulcers by scleroderma patients.
16011482|NCT02801305|Drug|Vaseline|This is used as the topical placebo agent.
16011483|NCT02801292|Drug|Ketamine|Single bolus of Ketamine .25 milligrams per kilogram of weight.
16011484|NCT02801279|Other|Conventional bilateral arm training|The Kinect-based bilateral arm training focuses activities that required the use of both hands by using Kinect game.
16011485|NCT02801279|Other|Kinect-based bilateral arm training|The conventional bilateral arm training focuses activities that required the use of both hands.
16011486|NCT02801266|Behavioral|Evidence informed birth control counseling|Counselors underwent training on the use of 10 best practices for contraceptive counseling.
16011487|NCT02801240|Other|Nutrition support product|Nutrition support product contains macronutrients, micronutrients, phytonutrients, prebiotics, and glutamine. Product is in powder form and is mixed with water or juice before consumption. Taken orally as a nutritional shake twice per day.
16011520|NCT02800967|Dietary Supplement|Placebo beverage|A polyphenol-free formulation with matched nutrient composition (sugars, vitamins, minerals) and similar sensory characteristics to active interventions
16011488|NCT02801227|Drug|Oxytocin|Intravenous oxytocin: 2.5 mIU per minute with increments of 2.5 mIU every 20 minutes until achieving 4-5 contractions during 10 minutes or 20 mIU. Then after continuous infusion without increasing oxytocin dose will be continued. In case of lack of painful contraction/active labor after 24 hours with oxytocin a trial with PGE2 will be initiated (as described for PGE2)
16011489|NCT02801227|Drug|Prostaglandin E2|PGE2 2 mg wil be inserted to the posterior fornix, this will be repeated every 6 hours until achieving painful contractions or up to 4 doses (24 hours). In case of lack of painful contraction/active labor after the fourth dose of PGE2 a trial with oxytocin will be initiated (as described for Oxytocin).
16011490|NCT02801214|Other|fMRI|
16011491|NCT02801201|Drug|Midazolam|
16011492|NCT02801201|Drug|Bupivacaine|
16011493|NCT02801188|Drug|Bupivacaine|Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5% and water soluble radio-opaque dye.
16011494|NCT02801188|Drug|Mixture of bupivacaine and dexmedetomidine|Paravertebral blockade will be performed using combined mixture of bupivacaine 0.5%, water soluble radio-opaque dye, and1 ug/kg of dexmedetomidine
16011495|NCT02801175|Procedure|Pulmonary vein isolation|
16011496|NCT02801162|Device|conventional ABG analyser|pO2 mmHg, pH, pCO2 mmHg, Base excess, Hct %
16011497|NCT02801162|Device|Proxima 3®|pO2 mmHg, pH, pCO2 mmHg, Base excess, Hct %
16011498|NCT02801149|Procedure|Wrist Magnetic Resonance Imaging (MRI)|Patients that enter this group are randomised to receive non-standard care with a 3-sequence MRI scan of the scaphoid following the initial conventional radiography.
16011499|NCT02801136|Behavioral|ReACT|
16011500|NCT02801136|Behavioral|Supportive Therapy|
16011501|NCT02801123|Behavioral|Mindfulness Based Cancer Recovery (MBCR)|Mindfulness-Based Cancer Recovery (MBCR) is a standardized group program which focuses primarily on the challenges faced by people living with cancer. It is an 8-week program consisting of weekly group meetings of 1.5 to 2 hours. Home practice of 45 minutes per day (15 min yoga; 30 min meditation) is prescribed. As the weeks progress, different forms of meditation are introduced, beginning with a body scan sensory awareness experience, progressing to sitting and walking meditations. Gentle Hatha yoga is incorporated throughout, as a form of moving meditation. Didactic instruction as well as group discussion and reflection, problem solving and skillful inquiry are commonly applied teaching tools.
16011502|NCT02801123|Behavioral|Tai Chi/Qigong (TCQ) for Cancer Patients|"TCQ involves a series of slow specific movements or forms done in a meditative fashion. It is purported that focusing the mind solely on the movements of the form helps to bring about a state of mental calm and clarity. The practice itself has been separated from its martial arts roots and is widely taught as a health behavior practice and exercise. Qigong exercises generally have three components: a posture (whether moving or stationary), breathing techniques, and mental focus on guiding qi through the body. Our program, developed specifically for a cancer patient population, incorporates simple Tai Chi elements within a healing framework stemming from Qigong principles."
16011503|NCT02801097|Drug|RRx-001|
16011504|NCT02801097|Drug|Irinotecan|
16011505|NCT02801084|Behavioral|Reduced environmental stimulation|"Participants will complete one arm involving four sequential float sessions. Float 1: chair float. Participants will first float in a comfortable chair in the supine position, for up to 90 minutes. The chair is in a room with sound and light attenuation. Orthostatic blood pressure (BP) will be measured before and after each float. Anxiety and body image will be measured afterwards.
~Float 2: open pool float. Participants will float for up to 90 minutes in an open pool (8 foot diameter, no enclosure). Orthostatic BP will be measured before and after each float. Anxiety and body image will be measured afterwards.
~Floats 3 & 4: domed pool float. Participants will float for up to 90 minutes in a domed pool the same size as the open pool, with an enclosure wall and 8 foot tall ceiling. Orthostatic BP will be measured before and after each float. Anxiety and body image will be measured afterwards.
~Each float will occur approximately 1 to 7 days apart."
16011506|NCT02801071|Drug|15g L-citrulline daily p.o.|
16011507|NCT02801071|Drug|Placebo|
16011508|NCT02801058|Other|Osteopathic manipulative treatment|Osteopathic manipulative techniques on thoracic diaphragm
16011509|NCT02801045|Behavioral|art therapy|"Patient's creativity is stimulated by visual arts materials and various art therapy techniques including punctual use of music, poetry and body expression. The intervention, based on the investigators previous experience, is founded on:
~humanistic phenomenological focus
~transpersonal therapeutic bound
~transdisciplinarity in the artistic approach
~integrative-relational specialized counseling of the grief, loss and trauma aspects."
16011510|NCT02801032|Drug|Tadalafil|"Single dose, 20 mg capsule p.o. minimum one week apart from placebo.
~MRI of cerebrum before the first trial day.
~Transcranial Doppler to measure blood flow velocity in MCA bilaterally before and after intervention.
~Near-infrared spectroscopy (NIRS) to measure cortical brain oxygenation before and after intervention.
~EndoPAT2000 to estimate endothelial function before and after intervention.
~Endothelial biomarkers in blood samples before and after intervention."
16011511|NCT02801032|Drug|Placebo|"Single dose, matching capsule p.o. minimum one week apart from active treatment.
~MRI of cerebrum before the first trial day.
~Transcranial Doppler to measure blood flow velocity in MCA bilaterally before and after intervention.
~Near-infrared spectroscopy (NIRS) to measure cortical brain oxygenation before and after intervention.
~EndoPAT2000 to estimate endothelial function before and after intervention.
~Endothelial biomarkers in blood samples before and after intervention."
16011512|NCT02801019|Other|E-poly|comparison of two different polyethylene plastic 0,04 mm at 3 months 0,06 at 2 years
16011513|NCT02801019|Other|ArComXL|comparison of two different polyethylene plastic 0,03 mm at 3 months 0,10 mm at 2 years
16011514|NCT02801006|Device|stenfilcon A|contact lens
16011515|NCT02801006|Device|etafilcon A|contact lens
16011516|NCT02800980|Procedure|Drainage and sclerotherapy.|Lymphocele percutaneous / transvaginal drainage with a use of a vascular catheter followed by sclerotherapy.
16011517|NCT02800980|Procedure|Drainage alone.|Lymphocele percutaneous / transvaginal drainage with a vascular catheter alone (without sclerotherapy).
16011518|NCT02800967|Dietary Supplement|Pure Aronia juice|Pure Aronia juice with appx. polyphenols content of 1000 mg gallic acid equivalents/100ml
16011519|NCT02800967|Dietary Supplement|Aronia juice-based beverage|Aronia juice-based beverage with appx. polyphenols content of 250 mg gallic acid equivalents/100ml, obtained as a blend of ¼ vol. of pure Aronia juice and ¾ vol. of placebo beverage.
16011523|NCT02800941|Drug|Oral anticoagulant treatment|The treatment is delivered according to the usual practice.
16011524|NCT02800928|Drug|CERC-501|CERC-501
16011525|NCT02800928|Drug|Placebo|Placebo
16011526|NCT02800915|Other|Service innovation with focus on interdisciplinary collaboration|The follow- up is performed via telemedicine to the patient in his or her own home, and in cooperation with the local health care workers.
16011527|NCT02800902|Drug|placebo|Oral prophylaxis followed by placement of placebo gel
16011528|NCT02800902|Drug|Rosuvastatin|Oral prophylaxis followed by placement of rosuvastatin gel
16011529|NCT02800902|Drug|Atorvastatin|Oral prophylaxis followed by placement of atorvastatin gel
16011530|NCT02800889|Drug|Pixantrone|Pixantrone
16011531|NCT02800876|Other|CT-acquisition|
16011532|NCT02800863|Device|Dorsal Root Ganglion (DRG) Stimulation (Axium™ Neurostimulator System)|Electrical stimulation of the DRG using the Axium™ Neurostimulator System
16011533|NCT02800863|Device|Dorsal Root Ganglion (DRG) Stimulation (Proclaim™ Neurostimulator System)|Electrical Stimulation of the DRG using the Proclaim™ Neurostimulator System.
16011534|NCT02800850|Behavioral|Bright Light|
16011535|NCT02800850|Behavioral|Placebo Light|
16011536|NCT02800824|Drug|Budesonide|
16011537|NCT02800824|Drug|Uceris|
16011538|NCT02800811|Drug|FR104|GMP FR104 is provided to the site in extractable volume vials containing FR104. Appropriate Dilutions in Ringer's lactate solution is made on site.
16011539|NCT02800811|Drug|Placebo|The placebo injection contains the vehicle. For placebo dosing, vehicle is administered in accordance with the volume of study drug administered.
16011540|NCT02800798|Other|Preeclampsia positive|
16011541|NCT02800785|Drug|Cefoxitin, Ertapenem, Moxifloxacin, Tigecycline, Ticarcillin-Clavulanic Acid; Metronidazole plus Cefazolin, Cefuroxime, Ceftriaxone, Cefotaxime, Ciprofloxacin, or Levofloxacin|Patients will be offered a treatment regimen of antibiotics based on guidelines published jointly by the Surgical Infection Society and the Infectious Disease Society of America. After IV antibiotics are administered for a period of at least 24 hours, a regimen of oral antibiotics will be continued for a total treatment length of 10 days. Preferred oral antibiotic regimens include Moxifloxacin alone, and combinations such as Metronidazole or Clindamycin, for anaerobic bacteria coverage, plus Ciprofloxacin or Levofloxacin, or an oral Cephalosporin for aerobic Gram-negative bacteria coverage.
16011542|NCT02800785|Procedure|Appendectomy|Appendectomy will be performed by an open or laparoscopic approach, depending on patient and surgeon preference.
16011543|NCT02800772|Dietary Supplement|acetic acid|
16011544|NCT02800772|Dietary Supplement|saline|
16011545|NCT02800759|Dietary Supplement|JOINTRUS®|100% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate
16011546|NCT02800759|Dietary Supplement|80% dose of JOINTRUS®|80% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate
16011547|NCT02800759|Dietary Supplement|62.4% dose of JOINTRUS®|62.4% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate
16011548|NCT02800759|Dietary Supplement|Starch 100%|0% Fatty acid compound with 12.5% Cis-9-cetylmyristoleate
16011549|NCT02800746|Drug|Ferric carboxymaltose|Ferric carboxymaltose 15 mg/kg mg is intravenously administered on 7-10 day before surgery.
16011550|NCT02800746|Drug|Placebo|normal saline 100 ml is intravenously administered on 7-10 day before surgery
16011551|NCT02800733|Dietary Supplement|Saffron|20 patients with mild to moderate GAD, diagnosed by Diagnostic and Statistical Manual of Mental Disorders-IѴ (DSM-IѴ) who receive sertraline will randomly receive saffron (450 mg) as an add-on therapy on daily bases for 6 weeks. Hamilton Anxiety Rating Scale (HAM-A) will use to assess the effect of treatment.
16011552|NCT02800733|Dietary Supplement|placebo|20 patients with mild to moderate GAD who receive sertraline will receive placebo too
16011553|NCT02800720|Behavioral|Meditation Awareness Training|8 Week Meditation Intervention
16011554|NCT02800720|Behavioral|Cognitive Behavioral Therapy for Groups|8 week intervention based on Cognitive Behavioral Theory
16011555|NCT02800707|Other|Sucralose|Sweetner
16011556|NCT02800707|Other|Stevia|Sweetner
16011557|NCT02800694|Drug|"bupivacainediluted with 1 ml of normal saline and 25 μg fentanyl "|The intrathecal medication included 1ml of 0.5% heavy bupivacaine (5 mg) diluted with 1 ml of normal saline and 25 μg fentanyl. Then, the parturients were placed in the supine position with left lateral displacement produced by placing a wedge under the right hip to prevent aortocaval compression and hypotension. Supplemental oxygen was applied using nasal cannula (2-4 L/min). Routine monitoring included maternal vital signs, uterine contractions and fetal heart rate tracing. The cardiotocogram was recorded continuously throughout the study period
16011558|NCT02800681|Other|Expert panel evaluation|"From the medical records, described social and psychiatric history and observed psychiatric symptoms will be summarized and presented to two senior psychiatric consultants. The panels evaluation ensures the identification of subjects with typical symptoms, according to a best estimate clinical consensus.
~The panel divides the participants into 4 groups: 'participant with symptoms typical of AS', 'participant with symptoms typical of SD', 'participant with inconclusive/non typical symptoms' and 'non eligible participant'."
16011559|NCT02800681|Other|Semi-structured psychopathological interviews|Included participants are asked for a detailed social and developmental history and interviewed with 3 semi-structured interviews: 1. Schedules for Assessment in Neuropsychiatry (SCAN); Covering psychopathology and behaviour associated with the major psychiatric disorders. 2. Autism Diagnostic Observation Schedule (ADOS), module 4; An assessment to identify symptoms within the autism spectrum. 3. Examination of anomalous self-experience (EASE); A checklist for exploration of experiential anomalies. The Ph.D.-student will obtain social and developmental history and carry out SCAN and EASE interviews. ADOS will be carried out by a consultant psychologist at The Danish Autism Centre.
16011560|NCT02800681|Other|Self-administered rating scales|1.The Autism Quotient (AQ), a 50 question scale, for the assessment of autistic traits, 2. The Schizotypal Personality Questionnaire (SPQ), a 74 item scale, for the assessment of schizotypal personality, 3. The WHO-5 Well-Being Index (WHO-5), a 5 item scale, for the assessment of subjective psychological well-being.
16011561|NCT02800681|Other|Other general interviewer ratings|1. Global Assessment of Functioning (GAF), a numeric scale (1 through 100) for assessing social, occupational, and psychological functioning, 2. The Clinical Global Impressions scale (CGI-Severity), an assessment of the clinician's global view of the patient's severity of psychopathology on a 7 point scale.
16011562|NCT02800668|Device|DJBL (Duodenal jejunal bypass liner, EndoBarrier)|Implantation of EndoBarrier after medical and patient's decision, Duration of treatment 12 months in maximum, follow up for 4 weeks after Explantation, follow up during treatment by physical examination, ECG control, sampling and analysis of blood parameters, mixed meal tolerance tests only for diagnostic purposes to assess gut hormonal changes and metabolic parameters
16011563|NCT02800655|Device|Digital Health Feedback System|"This intervention uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new technologies approved by the FDA, to collect information about patients taking their ARV medications. The wearable sensor records information, which is uploaded wirelessly to a mobile device and then to a secure computer. Together the sensors and the mobile device transmitting the information to the study computer are called a digital health feedback system (DHFS), which provides information about when patients have taken their ARV medications.
~Other Names:
~DHFS"
16011564|NCT02800642|Drug|Aflibercept (Eylea, BAY86-5321)|The recommended dose for intravitreal aflibercept was 2 mg equivalent to 50 μL. Study treatment was administered at baseline and at monthly intervals until stabilization of disease. When stability was achieved, the treatment interval could be extended based on visual and anatomic outcomes as judged by the treating investigator.
16011565|NCT02800629|Dietary Supplement|Modified Citrus Pectin|MCP versus placebo
16011566|NCT02800629|Dietary Supplement|Placebo|
16011567|NCT02800616|Other|The Healthy Primary School of the Future|In two out of four intervention schools, a whole-school approach named 'The Healthy Primary School of the Future', is implemented with the aim of improving physical activity and dietary behaviour. For this intervention, pupils are offered an extended curriculum, including a healthy lunch, more physical exercises, and social and educational activities, next to the regular school curriculum.
16011568|NCT02800616|Behavioral|The Physical Activity School|In the two other intervention schools, a physical-activity school approach called 'The Physical Activity School', is implemented, which is essentially similar to the other intervention, except that no lunch is provided.
16011569|NCT02800603|Behavioral|Family Check Up|"The FCU is an ecologically sensitive, evidence-based, targeted intervention that aims to reduce child EBP. Features of the FCU: 1) Assessment-driven: a multi-method, multi-informant assessment in which the consultant reviews strengths and difficulties across domains of contextual risk, family functioning and child health. A tailored intervention plan is then created based on results 2) Motivational interviewing: Caregivers engage in self-assessment about motivation and barriers to addressing factors that may perpetuate risk. The consultant and caregiver work to establish a menu of services 3) The family may be offered up to 6 sessions of the Everyday Parenting curriculum. The FCU has demonstrated effectiveness and cultural sensitivity across multiple US settings."
16011570|NCT02800590|Drug|ABP-700|
16011571|NCT02800577|Device|General Practitioner Emotional Test Battery (GP-ETB)|The GP-ETB (Class I Medical Device) comprises three computer tasks. In the first task, the 'Emotional Categorisation Task' patients are given forty words that might be used to describe them and indicate whether they would 'like' or 'dislike' to be described by a particular word. In the 'Facial Expression Recognition Task' patients are asked to judge whether a briefly displayed face is expressing one of six emotions. In the final task, the 'Emotional Recall Task', the patient should recall as many words as they can from the series of words that were presented in the first task. The patients perform these tasks once before antidepressant treatment and again seven days after treatment begins.
16011572|NCT02800564|Behavioral|Active mass media approach|Communities will be exposed to twice weekly radio programming for up to 18 months. Interactive voice response systems (IVRS) will be promoted where listeners can chose to receive pre-recorded audio/voice messages or text messages on mobile phones. Messages will be consistent with the weekly radio program. The topic of the radio program will be discussed in monthly open community meetings. Each individual may choose to participate or not to listen to the radio program, receive the IVRS system, and attend monthly meetings.
16011573|NCT02800564|Behavioral|Passive mass media approach|These communities will be exposed to twice weekly radio programming for up to 18 months only.
16011574|NCT02800551|Radiation|dose-intensified image-guided SBRT using simultaneous integrated boost|
16011575|NCT02800551|Radiation|External 3-dimensional conformal radiotherapy (3D-CRT)|
16011576|NCT02800538|Dietary Supplement|intragastric infusion of nutrient|Intragastric infusion of nutrient that can be widely found in daily food or placebo.
16011577|NCT02800525|Device|Picosecond laser|Picosecond 532 and 1064 nm laser Treatment of facial pigmented lesions. The energy using depends on the endpoint of immediate whitening of the lesions. The wavelength using depends on the depth of lesions.
16011578|NCT02800525|Device|Q-switched Nd:YAG laser|Q-switched Nd-YAG 532 and 1064 nm laser. Treatment of facial pigmented lesions. The energy using depends on the endpoint of immediate whitening of the lesions. The wavelength using depends on the depth of lesion.
16011579|NCT02800512|Procedure|Robotic sacrocolpopexy|Sacrocolpopexy is a procedure to surgically correct vaginal vault prolapse where mesh is used to hold the vagina in the correct anatomical position. Robotic assistance is a minimally invasive method to perform this abdominal procedure.
16011580|NCT02800512|Procedure|high uterosacral ligament suspension|Utilizing uterosacral ligaments to support the vaginal cuff can be performed vaginally-by passing sutures bilaterally through the uterosacral ligaments. near the level of the ischial spine. HUSLS is a vaginal minimally invasive procedure for POP.
16011581|NCT02800486|Drug|Intra-arterial Cetuximab|
16011582|NCT02800486|Drug|Intra-arterial Mannitol|
16011583|NCT02800486|Radiation|Hypofractionated re-irradiation|
16011584|NCT02800473|Device|Strorz (commercial)|
16011585|NCT02800473|Device|CyPaM2 (experimental)|
16011586|NCT02800460|Procedure|fMRI-3T|fMRI-3T will be performed during the visit 1: day of anesthesia consultation (this fMRI-3T will last approximately one hour)
16011587|NCT02800447|Drug|Natulan|Each baseline BEACOPP regimen lasts 21 days, and each cycle consists of： Cyclophosphamide injection: 650mg/m2, IV infusion, day 1； Doxorubicin hydrochloride injection: 25mg/m2, IV infusion, day 1； Etoposide injection: 100mg/m2, IV infusion, day 1~3; Natulan (procarbazine hydrochloride capsule): 100mg/m2，po, day 1~7; Bleomycin hydrochloride injection: 10mg/m2, IV or IM, day 8; Vincristine: 1.4mg/m2 (single maximum dose is 2mg), IV infusion, day 8; Prednisone tablet: 40mg/m2, po, day 1~14
16011653|NCT02799823|Device|HLT Transcatheter Aortic Valve System|Transcatheter aortic valve replacement with HLT Transcatheter Aortic Valve System
16011749|NCT02799147|Drug|Bendamustine|
16011588|NCT02800447|Drug|ABVD|Each ABVD cycle lasts 28 days1 cycle of the ABVD regimen consists of： Doxorubicin hydrochloride injection：25mg/m2，IV infusion，day 1 and 15; Dacarbazine injection：375mg/m2，IV infusion，day 1 and 15； Bleomycin injection：10mg/m2，IV or IM，day 1 and 15； Vincristine injection：1.4mg/m2 (single maximum dose is 2mg), IV infusion，day 1 and 15;
16011589|NCT02800434|Procedure|hand allograft|
16011590|NCT02800408|Other|Whole grain high-BCX maize|The whole grain orange maize will be milled and prepared into muffins to be consumed daily. Muffins will contain a target of 500 µg beta-cryptoxanthin per day.
16011591|NCT02800408|Other|Refined grain high-BCX maize|The refined grain orange maize will be degermed, milled, and prepared into muffins to be consumed daily. Muffins will contain a target of 500 µg beta-cryptoxanthin per day.
16011592|NCT02800408|Other|Whole grain white maize|The whole grain white maize will be milled and prepared into muffins to be consumed daily. Muffins will contain minimal beta-cryptoxanthin, matched for dry maize weight.
16011593|NCT02800395|Procedure|Malnutrition screening and perioperative nutritional support|"Multidisciplinary training sessions for malnutrition and malnutrition risk screening, postoperative nutritional procedures according to the ESPEN Guidelines
~Preoperative Geriatric evaluation : eligibility criteria, nutritional status, previous history, comorbidities, clinical examination, activities of daily living (ADL) and Instrumental activities of daily living (IADL)
~Implementation of an adapted nutritional support based on ESPEN Guidelines"
16011594|NCT02800382|Other|Take samples|Fiberoptic bronchoscopy was performed under local anaesthesia and sedation for taking Bronchoalveolar Lavage Liq for Paraoxanase activity. Blood samples were taken too.
16011595|NCT02800369|Biological|ZFN-603 and ZFN-758|Each suppository contain 500 µg of ZFN-603 or ZFN-758
16011596|NCT02800356|Procedure|Subthreshold 577 nm yellow wavelength laser photo-coagulator|"Subthreshold photocoagulation is a method in which the burn spots (treated areas) cannot be seen with biomicroscopy, on color fundus photograph, on Optical Coherence Tomography or Fluorescein Angiography when the subthreshold level is adequately set. Subthreshold photocoagulation can be considered to be truly minimally invasive or non-damaging photocoagulation. A term sometimes used is photo-thermal stimulation since the Retinal Pigment Epithelium (RPE) layer is heated and stimulated, but not destroyed.
~The threshold level output power is set to obtain barely visible burn at approximately 200 mW to 250 mW using the titration mode, and irradiation is conducted after switching over to Endpoint Management."
16011597|NCT02800343|Procedure|routine administration of 0.9% sodium chloride|0.9% sodium chloride is used as the wash and suspension solution for red blood cells during the Intraoperative red blood cell salvage (ICS) procedure.
16011598|NCT02800330|Drug|Esomeprazole 40mg concomitantly|During phase B the patients will use esomeprazole 40mg concomitantly with regorafenib for 5 days.
16011599|NCT02800330|Drug|Esomeprazole 40mg before|During phase C the patients will use esomeprazole 40mg 3 hours before regorafenib for 5 days.
16011600|NCT02800330|Drug|Regorafenib 160mg or 120mg|Patients will use regorafenib 160mg or 120mg during all phases (A, B, C)
16011601|NCT02800317|Procedure|RISAS|RISAS procedure contains Radioactive Iodine Seed localisation in the Axilla in axillary node positive breast cancer combined with a Sentinel node procedure.
16011602|NCT02800278|Other|observational|describe bone status and outcome of odontoid fracture
16011603|NCT02800265|Dietary Supplement|Avmacol|Avmacol is an over-the-counter mixture of broccoli seed and sprout extracts in tablet form to promote detoxification. These tablets contain natural substances that stimulate the body's own defense mechanisms against toxic substances commonly encountered in the environment, such as air pollution and tobacco smoke.
16011604|NCT02800252|Drug|Placebo|One-stage full-mouth periodontal ultrasonic debridement plus placebo intervention
16011605|NCT02800252|Drug|3g omega-3 plus 100mg aspirin daily for 60 days|Full-mouth periodontal debridement, 3g omega-3 plus 100mg aspirin daily for 60 days after periodontal therapy
16011606|NCT02800252|Drug|omega-3 plus aspirin before periodontal therapy|Full-mouth periodontal debridement, 3g omega-3 plus 100mg aspirin daily for 60 days before periodontal therapy
16011607|NCT02800239|Dietary Supplement|Amino Acid Intake|Amino acid intakes will be varied at 0.2-2.67 g/kg/d
16011608|NCT02800226|Device|10Hz|Magventure Cool B70 Coil with X100 Stimulator and ANT Neuronavigation System
16011609|NCT02800226|Device|iTBS|Magventure Cool B70 Coil with X100 Stimulator and ANT Neuronavigation System
16011610|NCT02800213|Device|Modified Ambu Spur II bag valve mask|Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a modified Ambu Spur II bag valve mask with a supplemental external handle
16011611|NCT02800213|Device|Conventional Ambu Spur II bag valve mask|Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a conventional Ambu Spur II bag valve mask
16011612|NCT02800200|Procedure|Platelet rich plasma|Sono-guided injection with 3 cc Platelet rich plasma were performed in both groups.
16011613|NCT02800200|Device|shock wave|Shock waves are defined a sequence of acoustic pulse characterized by a high peak pressure (100 MPa), fast pressure rise (< 10 ns) and short duration (10 μs).
16011614|NCT02800187|Device|ESWT|Shock waves are defined a sequence of acoustic pulse characterized by a high peak pressure (100 MPa), fast pressure rise (< 10 ns) and short duration (10 μs).
16011615|NCT02800174|Device|Smart nitinol stent implantation|Before intervention, clopidogrel (75 mg/d), aspirin (100 mg/d) and atorvastatin (40 mg/d) were prescribed. One week later, aortic arch and aortocranial angiography were performed under general anesthesia to determine the site, range and extent of the lesion and the status of the cerebral microcirculation, and consequently to inform the treatment strategy and the selection of the correct size of self-expanding nitinol stent system.
16011616|NCT02800174|Drug|antiplatelet drug|Patients with carotid artery stenosis treated conservatively were commenced on an indefinite course of one or more oral antiplatelet drugs. The antiplatelet regimes comprised 100 mg or 300 mg aspirin before sleep with clopidogrel 125 mg or 250 mg daily; or 75 mg clopidogrel before sleep daily.
16011617|NCT02800161|Drug|Trehalose|Trehalose 70g/die
16011618|NCT02800161|Drug|Maltose|Maltose 70g/die
16011619|NCT02800148|Drug|Azelaic acid foam|
16011620|NCT02800148|Drug|Azelaic acid foam|
16011621|NCT02800148|Drug|Azelaic acid foam - Placebo|
16011622|NCT02800135|Drug|Furosemide|1.0 mg/kg of intravenous furosemide. In order to minimize the risk of hypovolemia, urine output will be replaced ml for ml with either Ringers lactate or normal saline for six hours after the furosemide stress test.
16011623|NCT02800096|Behavioral|Gambling Internet intervention|The gambling Internet intervention consists of a new online version of self-change tools that have previously been translated successfully into an online form and shown to have a significant impact on gambling in three trials. A major focus of this intervention is to provide individuals with clear and concise behavioral and cognitive strategies for meeting the goal of reducing or quitting gambling.
16011624|NCT02800096|Behavioral|MoodGYM|Internet intervention for depression and anxiety - MoodGYM, an extensively evaluated intervention found to be effective in a variety of different settings.
16011625|NCT02800083|Drug|Pitolisant (BF2.649)|
16011626|NCT02800083|Drug|Placebo|
16011627|NCT02800070|Biological|Lentivirus Alpha-gal A transduced stem cells|
16011628|NCT02800044|Device|Wearing a non-invasive glucose sensor|Glucose readings will be obtained from both a glucometer (fingerstick readings) and from the non-invasive glucose sensor at the following four timepoints: fasting, 1.5 to 2 hours after consuming a meal, and before and after 15-30 minutes of moderate exercise on a stationary bicycle.
16011629|NCT02800031|Device|Transvaginal ultrasonography|
16011630|NCT02800018|Other|risk factors|investigators will analyze if certain risk factors will influence the progression of the encephalopathy
16011631|NCT02800005|Device|AFA group (successive patients)|The abdominal fat area at the umbilical level was measured using a CT scanner(sango Mount Monitor Wireless Panel; Siemens , Munich, Germany) while the examinee was in a supine position and estimated using a Volume software (fat Pointer; Siemens , Munich, Germany). The imaging conditions were 120 kilovolt and 50 milliampere, using a 5-mm-thick slice.The areas covered by visceral fat software calculated from pixels with densities ranging from-190 to -30 hounsfield unit . No contrast agent is needed.
16011632|NCT02800005|Other|BMI group (successive patients)|The formula for BMI is weight in kilograms divided by height in meters squared (kg/m2). the normal range is usually considered to be 18.5 to 24.9, with less than 18.5 considered underweight, more than 25.0 considered overweight and above 30.0 obese.
16011633|NCT02799992|Procedure|689 nm Laser Treatment of the Macula|
16011634|NCT02799992|Procedure|Half Dose Photodynamic Therapy|
16011635|NCT02799979|Device|3D right ventricular imaging echocardiographic|Echocardiographic data (3D right ventricular imaging echocardiographic) will be collected at baseline and after 6months.
16011636|NCT02799966|Device|Myndmove|20 sessions of 1 hour treatments with the MyndMove device (functional electrical stimulation) to the muscles of the upper limb(s), conducted 3 to 5 times per week, over 4 to 7 weeks.
16011637|NCT02799953|Device|Technology-based self-management model|Participants in the technology-augmented self-monitoring model (intervention group) will use a tablet-based, interactive touch screen self-monitoring system to monitor and manage their chronic conditions. The system is designed to augment patients' abilities to assess, record, and review their health signs while providing text-, audio-, and video-based resources supporting disease self-care.
16011638|NCT02799927|Procedure|Indirect Pulp Treatment with Bioactive Dentin Substitute|The indirect pulp treatment (IPT), with Biodentine is a vital pulp procedure for dep cariously primary teeth without carious exposure, involving the removal of the softened, humid and infected dentin layer, leaving intact intentionally the deepest layer of the dentin-pulp complex, followed by the placement of Biodentine and a hermetic restoration to provide a seal against microleakage, without the necessity to reenter for removing the residual caries.
16011639|NCT02799927|Procedure|Indirect Pulp treatment with Calcium hydroxide|The indirect pulp treatment (IPT), with Biodentine is a vital pulp procedure for dep cariously primary teeth without carious exposure, involving the removal of the softened, humid and infected dentin layer, leaving intact intentionally the deepest layer of the dentin-pulp complex, followed by the placement of Ultra-Blend plus, and a hermetic restoration to provide a seal against microleakage, without the necessity to reenter for removing the residual caries.
16011640|NCT02799914|Device|Sinus-Venous stent (Optimed GmbH)|Stent implantation
16011641|NCT02799901|Biological|Nivolumab|Injection of nivolumab
16011642|NCT02799901|Radiation|hypofractionned radiotherapy|radiation
16011643|NCT02799888|Drug|Maraviroc|Maraviroc will be administered 300mg twice daily and start on day -2 end on day +30 after stem cell transplant for 33 days.
16011644|NCT02799888|Drug|Cyclosporine (in HLA-Unrelated Donor Transplantation)|Cyclosporine will be given intravenously at a dose of 2-3 mg/kg starting Day -1. Subsequent dosing will be based on blood levels. Patients were advanced to oral cyclosporine once they could tolerate. The dose should be adjusted accordingly to maintain a suggested target serum level of 150-250 ng/mL. In the absence of aGVHD, the oral cyclosporine dose was reduced by approximately 5% weekly, beginning on or near day 100, and therapy was usually discontinued by Day 180 after transplantation or relapse.
16011645|NCT02799888|Drug|Tacrolimus (in HLA-Mismatched Related Donor Transplantation)|Tacrolimus will be given orally at a dose of 0.05 mg/kg twince a day or intravenously at a dose of 0.03 mg/kg starting Day -3. Subsequent dosing should be adjusted accordingly to maintain a suggested target serum level of 5-10 ng/mL. Tacrolimus taper can be initiated at a minimum of 100 days post HSCT if there is no evidence of active GVHD. The rate of tapering will be done according institutional practices but patients should be off tacrolimus by Day 180 post HSCT if there is no evidence of active GVHD.
16011646|NCT02799888|Drug|Methotrexate|Methotrexate will be administered intravenously at a dose of 15 mg/m^2 on day +1, and 10 mg/m^2 on day +3, +6 and +11 after HSC transplantation.at the doses of 15 mg/m^2 IV bolus on Day +1, and 10 mg/m^2 IV bolus on Days +3, +6 and +11 after hematopoietic stem cell infusion. The Day +11 dose of methotrexate will be not given to those patients who fail to reach white blood cell count (WBC) of more than 1.0×10^9/L.
16011647|NCT02799875|Other|Higher permissive hypercapnia|"pCO2 ≥ 60mmHg with an upper limit ≤ 75mmHg;
~pH ≥ 7.20 from a capillary or arterial blood sample;"
16011648|NCT02799875|Other|Lower Permissive Hypercapnia|"pCO2 ≥ 40mmHg with an upper limit ≤ 55mmHg;
~pH ≥ 7.25 from a capillary or arterial blood sample;"
16011649|NCT02799862|Drug|Nab-Paclitaxel|Nab-Paclitaxel will be administered in accordance with the SmPC of Nab-Paclitaxel.
16011650|NCT02799862|Drug|Carboplatin|Carboplatin will be administered as combination partner of Nab-Paclitaxel in accordance with SmPC of Nab-Paclitaxel.
16011651|NCT02799849|Other|Sleep and metabolism assessment|
16011652|NCT02799836|Device|Blindfold|Study subjects will be blindfolded to create an environment of complete light deprivation which will be worn for 48 hours.
16011746|NCT02799147|Procedure|Allogeneic stem cell transplantation|
16011654|NCT02799797|Procedure|ultrasound guided long axis placement of adductor canal catheter|The long axis of the ultrasound probe is placed parallel to the long axis of the adductor canal while scanning, and the catheter is placed along the long axis of the canal using an in-plane approach
16011655|NCT02799797|Procedure|ultrasound guided short axis placement of adductor canal catheter|The long axis of the ultrasound probe is placed vertical to the long axis of the adductor canal while scanning, and the catheter is placed along the short axis of the canal using an in-plane approach
16011656|NCT02799797|Device|Philip CX 50 Ultrasound Scanner|The linear (C5-12) probe of Philip CX 50 Ultrasound Scanner is used for scanning
16011657|NCT02799797|Device|PAJUNK Contiplex S Catheter|
16011658|NCT02799797|Drug|Ropivocaine|0.2% ropivacaine 10ml is given as loading dose. Following that, 0.2% ropivacaine 5ml/h is given as maintenance dose.
16011659|NCT02799797|Drug|rescue sulfentanil given postoperatively as PICA|bolus: 2mg, lock time: 10min, 1h limitation: 8mg
16011660|NCT02799784|Drug|UMEC/VI|ELLIPTA dry powder inhaler (DPI) will contain a total of 30 doses. Each DPI will be comprised of two double-foil, laminate blister strips. Each blister of one strip will consist of 62.5 mcg of UMEC blended with lactose and magnesium stearate while each blister of other strip will consist of 25 mcg of VI blended with lactose and magnesium stearate. Each actuation of the DPI will deliver the contents of one blister from each strip simultaneously
16011661|NCT02799784|Drug|TIO/OLO|TIO/OLO inhalation spray will be supplied as an inhalation spray delivered using a RESPIMAT inhaler. Each actuation from the RESPIMAT inhaler delivers 3.124 mcg tiotropium bromide monohydrate (equivalent to 2.5 mcg tiotropium) and 2.736 mcg olodaterol hydrochloride (equivalent to 2.5 mcg olodaterol)
16011662|NCT02799784|Drug|Albuterol/salbutamol|Albuterol/salbutamol will be supplied as an inhalation spray via metered dose inhaler and will be issued for reversibility testing at Visit 1. Albuterol/salbutamol will be permitted throughout the study for use as-needed
16011663|NCT02799758|Drug|NK-104-CR|NK-104-CR 8 mg for 52 weeks
16011664|NCT02799758|Drug|Livalo® IR|Livalo® IR 4 mg daily for 52 weeks
16011665|NCT02799758|Drug|Placebo (for NK-104-CR)|NK-104-CR 8 mg placebo for 52 weeks
16011666|NCT02799758|Drug|Placebo (for Livalo® IR)|Livalo® IR 4 mg placebo for 52 weeks
16011667|NCT02799745|Drug|Enzalutamide|Oral
16011668|NCT02799745|Other|Active Surveillance|
16011669|NCT02799706|Drug|Degarelix|a GnRH antagonist will be given for a predefined duration of 18, 24, or 36 months as per institution policy
16011670|NCT02799706|Drug|approved GnRH agonist|A non-steroidal anti-androgen (e. g. flutamide, bicalutamide) will be given orally one week before the first injection of the GnRH agonist and will be continued for no longer than 8 weeks to protect against flare.Dose may vary due to availability of different brand names and pharmaceutical forms The start of antiandrogen must be registered as day 1 of treatment in the GnRH agonist arm.
16011671|NCT02799706|Radiation|Radiotherapy|.As the study investigates the effect of two drugs given concomitantly to radiotherapy, all patients will be treated with the same treatment technique and target dose. The preferred treatment technique is intensity modulated radiotherapy (IMRT)
16011672|NCT02799680|Biological|allogeneic CART-33|allogeneic CD33-directed chimeric antigen receptor-modified T cells (CART-33)
16011673|NCT02799667|Device|Standard Dressing|Patients are randomized to the standard dressing at the time of fascial closure.
16011674|NCT02799667|Device|Negative Pressure Wound Therapy Dressing|Patients are randomized to the NPWT at the time of fascial closure.
16011675|NCT02799641|Drug|Diazepam|5 mg Diazepam
16011676|NCT02799641|Drug|Lidocaine|2 ml of 2% lidocaine
16011677|NCT02799641|Other|Placebo pill|Placebo pill
16011678|NCT02799641|Other|Placebo injection|Placebo injection
16011679|NCT02799628|Behavioral|intervention|intervention with recommendation and therapist introduction
16011680|NCT02799628|Other|placebo|low back pain education, and physical therapy 3 times per week
16011681|NCT02799615|Drug|Infliximab|No standard dosing regimen will be used and the dose of infliximab will be determined by the treating physician
16011682|NCT02799602|Drug|BAY1841788 / darolutamide (ODM-201)|600mg (2 tablets of 300 mg) of darolutamide (ODM-201)/placebo twice daily with food, equivalent to a total a daily dose of 1200 mg in addition to standard ADT (luteinizing hormone releasing hormone (LHRH) agonist/antagonist or orchiectomy) and 6 cycles of docetaxel
16011683|NCT02799602|Drug|Standard ADT (androgen deprivation therapy)|As prescribed by the treating physician.
16011684|NCT02799602|Drug|Docetaxel|As prescribed by the treating physician.
16011685|NCT02799602|Drug|Placebo|Placebo matching darolutamide (ODM-201) tablets in appearance, bid orally with food, in addition to standard ADT (luteinizing hormone releasing hormone [LHRH] agonist/antagonist or orchiectomy) and 6 cycles of docetaxel.
16011686|NCT02799589|Drug|Remifentanil|1mcg/kg over 1 min followed by an infusion (0.05-0.5 mcg/kg/min)
16011687|NCT02799589|Drug|Dexmedetomidine|1mcg/kg over 10 mins followed by and infusion (0.2-0.7 mcg/kg/hr)
16011688|NCT02799589|Drug|Ropivacaine|Caudal anesthesia block with Ropivicaine 0.2% 1ml/kg injected into the caudal space
16011689|NCT02799576|Device|Curved needle|In this arm, the curved block needle will be used for regional blockade
16011690|NCT02799563|Other|Coach, Preselected number of cases|
16011691|NCT02799563|Other|Coach, Self-selected number of cases|
16011692|NCT02799563|Other|No coach, Preselected number of cases|
16011693|NCT02799563|Other|No coach, Self-selected number of cases|
16011694|NCT02799550|Biological|allogeneic CART-19|allogeneic CD19-directed chimeric antigen receptor-modified T cells (CART-19)
16011695|NCT02799537|Other|Randomized clinical study|Participants will be randomly assigned to one of two advance directives and we will assess which they prefer. This is not a human health intervention
16011696|NCT02799524|Other|comparison of screening scales|Concordance degrees Assessment of each of 2 scales ( HADS and GDS ) from the DSM- V , for diagnostic confirmation of major depressive episodes in elderly patients with cancer or haematological malignancies
16011697|NCT02799511|Biological|protein expression|Differential protein expression between the period of acute cerebral ischemia and the control period
16011698|NCT02799498|Device|Auto-injector device|Single 50 mg subcutaneous dose of liquid etanercept (ENBREL®) in a 1.0 ml pre-filled syringe administered via an auto-injector device manufactured by Scandinavian Health Limited (SHL)
16011750|NCT02799134|Drug|Dexamethasone|
16011699|NCT02799498|Other|Etanercept (ENBREL®) via Manual injection|Single 50 mg subcutaneous dose of liquid etanercept (ENBREL®) in a 1.0 ml pre-filled syringe administered via manual injection (reference treatment) to compare to the auto-injection
16011700|NCT02799498|Drug|Etanercept (ENBREL®)|Single 50 mg subcutaneous dose of liquid etanercept (ENBREL®) in a 1.0 ml pre-filled syringe administered via an auto-injector device manufactured by Scandinavian Health Limited (SHL)
16011701|NCT02799485|Other|Laboratory Biomarker Analysis|Correlative studies
16011702|NCT02799485|Other|Pharmacological Study|Correlative studies
16011703|NCT02799485|Behavioral|Quality-of-Life Assessment|Ancillary studies
16011704|NCT02799485|Biological|Recombinant EphB4-HSA Fusion Protein|Given IV
16011705|NCT02799472|Drug|GSK3196165|GSK3196165 is supplied as liquid and will be administered as SC injection.
16011706|NCT02799472|Drug|Placebo|0.9% weight by volume (w/v) sodium chloride solution administered as SC injection.
16011707|NCT02799472|Drug|MTX|Capsule, tablet or liquid administered orally or as SC injection.
16011708|NCT02799472|Drug|Folic (or folinic) acid|Capsule, tablet or liquid and will be administered orally.
16011709|NCT02799459|Procedure|General anaesthesia|the patient will receive a general anaesthesia do proceed at her conization
16011710|NCT02799459|Procedure|Hypnosis in conization|this is the experimental treatment which is allocated to the experimental group
16011711|NCT02799446|Drug|Reslizumab|Reslizumab 3mg/kg intravenous (IV)
16011712|NCT02799446|Drug|Placebo|Matching Placebo intravenous (IV)
16011713|NCT02799433|Behavioral|Usual services + HAP|The HAP process includes child care center providers completing a self-assessment(s), setting improvement goals, receiving technical assistance materials, attending topic-specific workshops, improving best practices, re-self-assessment and qualification for a HAP award.
16011714|NCT02799433|Behavioral|Usual services|Control condition
16011715|NCT02799420|Device|GastroFlex UHD, Cellvizio; Mauna Kea Technologies, Paris, France|The patients who enrolled the pCLE group will undergo endoscopic biopsy using pCLE. The cancerous lesion is observed using probe-based confocal laser endomicroscopy. The biopsy was done at the most suspicious parts of the cancerous lesion.
16011716|NCT02799420|Device|white light endoscopy (WLE)|The patients who enrolled this group will undergo endoscopic biopsy under standard white light endoscopy
16011717|NCT02799407|Other|ResearchKit Consent|Multi-tiered consent form using the Apple ResearchKit Platform.
16011718|NCT02799394|Other|Activity modification, exercises and gradual return to sport|
16011719|NCT02799381|Drug|Optimized antiparkinsonian treatment|Dose levels of prescribed antiparkinsonian medications were individually optimized to their maximum therapeutic effect.
16011720|NCT02799381|Drug|Levodopa-Carbidopa Intestinal Gel (LCIG)|Dose levels were individually optimized.
16011721|NCT02799381|Device|CADD-Legacy ambulatory infusion pump|(manufactured by Smiths Medical)
16011722|NCT02799381|Device|Percutaneous endoscopic gastrostomy tube|(PEG tube)
16011723|NCT02799381|Device|Jejunal extension tube|(J-tube)
16011724|NCT02799368|Drug|CJ Plasma Solution A Injection|Intravenous plasma solution (Chloride 90 mmoL/L) at 3 mL/kg over 1 hour pre-contrast, followed by the same solution intravenously at 1.5 mL/kg/hr for 4 hours. Intra-vascular low-osmolal or iso-osmolal contrast will be used.
16011725|NCT02799368|Drug|CJ 0.9% Normal Saline Injection|Intravenous plasma solution (Chloride 154 mmoL/L) at 3 mL/kg over 1 hour pre-contrast, followed by the same solution intravenously at 1.5 mL/kg/hr for 4 hours. Intra-vascular low-osmolal or iso-osmolal contrast will be used.
16011726|NCT02799355|Drug|Sofosbuvir, Ribavirin, With or Without Pegylated Interferon|Retrospective will carried out to find percentage of patients with sustained virologic response at 12 weeks after the end of treatment
16011727|NCT02799316|Other|HBV core antibodies testing. • Real time PCR testing.|"HBV core antibodies testing in HBV surface antigen negative patients.
~Real time PCR testing for those having positive HBc antibodies."
16011728|NCT02799303|Device|Multi-parametric MRI|Non contrast magnetic resonance imaging using T1/T2 weighting, DWI and ADC will be performed. MRI images will be reviewed by a single uro-radiologist and assessed using the PiRADs standards.
16011729|NCT02799303|Other|PSA testing|Serum prostate specific antigen (PSA) testing will be performed using a standardized laboratory assay.
16011730|NCT02799290|Biological|ADIPOSE TISSUE EXTRACT|Adipose tissue extract is obtained on site with lipoaspirate adipose tissue prepared though incubation and filtration
16011731|NCT02799290|Biological|PLATELET-RICH PLASMA GEL|Autologous platelet rich plasma is obtained onsite and activated following commercial kit instructions
16011732|NCT02799277|Drug|Testosterone|Effect of testosterone on moral decision making
16011733|NCT02799277|Drug|Placebo|Effect of testosterone on moral decision making
16011734|NCT02799264|Drug|Cabotegravir 30 mg|Cabotegravir (GSK1265744B ) is available as white to almost white, oval shaped, film coated tablet, of weight 515 mg. The tablet contains micronized cabotegravir, lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycolate, and magnesium stearate. Each tablet is equivalent to 30 mg cabotegravir and needs to be taken orally with 240 mL of water. Cabotegravir tablet will be administered to subjects either in fasting condition or following a high fat meal.
16011735|NCT02799251|Other|Collection of plasma cell rate|Lymphocytes counts are obtained from patients undergoing pulmonary or digestive cancer surgery. The rates are assessed before surgery (day 0) and at days 1, 3, 5 and 8 after surgery. Anesthetic and surgical procedures are collected as well as risk factors for postoperative infections recognized in the literature. Clinical and biological signs of infection are collected.
16011736|NCT02799238|Biological|ALECSAT|3 doses of ALECSAT/4 weeks followed by ALECSAT/3 months
16011737|NCT02799238|Radiation|Radiotherapy|Radiotherapy 5 days/week for 6 weeks
16011738|NCT02799238|Drug|Temozolomide|Temozolomide daily for 6 weeks followed by 6 cycles 5days/4weeks
16011739|NCT02799212|Drug|somatostatin infusion|postoperative somatostatin infusion during 5 days at 6mg/day, followed by one day at 3mg/day.
16011740|NCT02799212|Drug|placebo infusion|Placebo infusion (50ml of 0.9% NaCl/day) during 6 days.
16011741|NCT02799186|Procedure|blood sample for genetic analysis|
16011742|NCT02799173|Biological|RANKL/OPG ratio|
16011743|NCT02799173|Device|bone densitometry|
16011744|NCT02799173|Device|fan beam CT scan|
16011745|NCT02799173|Device|Doppler ultrasound|
16011752|NCT02799121|Device|ReGenerCell™ Autologous Cell Harvesting Device|
16011753|NCT02799108|Device|NIRS|High-resolution EEG-fNIRS recording lasting a maximum of 30 minutes by using expressive and receptive language paradigms
16011754|NCT02799108|Device|fMRI|fMRI acquisition under the same stimulation conditions
16011755|NCT02799095|Drug|ALKS 4230|Intravenous (IV) infusion over 30 minutes given daily for 5 consecutive days followed by an off-treatment period
16011756|NCT02799095|Drug|ALKS 4230 + pembrolizumab|IV infusion of ALKS 4230 over 30 minutes given daily for 5 consecutive days followed by an off-treatment period; pembrolizumab administered IV once with ALKS 4230 on the first day of each cycle
16011757|NCT02799082|Drug|Vehicle|topical treatment for photodynamic therapy combining vehicle application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation).
16011758|NCT02799082|Drug|BF-200 ALA|topical treatment for photodynamic therapy combining drug application and subsequent illumination with broad or narrow spectrum light sources (after 3 h of drug incubation).
16011759|NCT02799069|Drug|BF-200 ALA|topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.
16011760|NCT02799069|Drug|MAL Cream|topical treatment for photodynamic therapy combining drug application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.
16011761|NCT02799069|Drug|Vehicle|topical treatment for photodynamic therapy combining vehicle application and after a 3 h incubation subsequent illumination with a broad or narrow spectrum light source.
16011762|NCT02799056|Device|Thoracic ultrasound|The ultrasound will be performed using the ultrasound system GE Logiq XP equipped with a linear probe of 10 MHz. The diaphragm is visualized as two parallel echogenic lines at the eighth intercostal space in the mid-axillary line. The images will be captured during the inspiratory and expiratory tidal volume to and during maximum inspiration and expiration. Each image will be frozen in B mode and the diaphragm thickness will be measured from the center line pleural half the peritoneal line. The fraction of diaphragmatic thickening it is calculated by the formula: diaphragmatic thickness at the end of inspiration - thickness to diaphragmatic at the end of exhalation / diaphragmatic thickness at the end of exhalation x 100. The number of areas with lines B also will be measured.
16011763|NCT02799043|Procedure|Standard PVI|Standard PVI procedure without FIRMap.
16011764|NCT02799043|Procedure|FIRM-Guided Procedure and PVI|
16011765|NCT02799030|Drug|BF-200 ALA 1%|topical treatment for photodynamic therapy combining drug application and after 3 h of drug incubation subsequent illumination with a broad spectrum light source .
16011766|NCT02799030|Drug|BF-200 ALA 3%|topical treatment for photodynamic therapy combining drug application and after 3 h of drug incubation subsequent illumination with a broad spectrum light source .
16011767|NCT02799030|Drug|BF-200 ALA 10%|topical treatment for photodynamic therapy combining drug application and after 3 h of drug incubation subsequent illumination with a broad spectrum light source .
16011768|NCT02799017|Other|Intensive Phonology Treatment|Phonology based reading, writing, and naming therapy.
16011769|NCT02799017|Other|Intensive SFA Treatment|Semantic based reading, writing, and naming therapy.
16011770|NCT02798991|Drug|GSK3179106|It is uncoated round or oblong tablet with 3 strengths viz;. 5, 25 and 100 mg. It is White to slightly colored tablet and will be administered orally
16011771|NCT02798991|Drug|Matched Placebo|It is uncoated round or oblong placebo tablet prepared to match actives across all strengths. It is White to slightly colored tablet and will be administered orally
16011772|NCT02798978|Drug|GSK1795091|GSK1795091 will be supplied as solution for injection vial. Each 5 mL vial contains 0.001 milligram/mL (mg/mL; 1000 ng/mL) or 0.0001 mg/mL (100 ng/mL)of GSK1795091 and will be administered as IV bolus over 2-5 minutes (min) followed by a IV bolus of 10 mL normal saline.
16011773|NCT02798978|Drug|Placebo|Matching placebo will be supplied as a solution for injection vial and will be administered as IV bolus over 2-5 min followed by a IV bolus of 10 mL normal saline
16011774|NCT02798965|Biological|serodiagnosis|
16011775|NCT02798952|Biological|Engerix-B Kinder|Subjects previously primed and boosted with 4 doses of Infanrix hexa vaccine in the first 2 years of life received a single dose of Engerix-B Kinder vaccine as an intramuscular (IM) injection into the deltoid region of the non-dominant arm at 14-15 years of age.
16011776|NCT02798926|Device|polyethylene bag|The infant will be wrapped in a polyethylene bag 15 min before starting central venous catheter placement
16011777|NCT02798913|Drug|Short DAPT|acetylsalicylic acid 100 mg/day life-long + clopidogrel 75 mg/day for 3 months
16011778|NCT02798913|Drug|Long DAPT|acetylsalicylic acid 100 mg/day life-long + clopidogrel 75 mg/day for 12 months
16011779|NCT02798900|Other|Functional task-training|The functional task-training program includes warming up followed by a functional circuit with muscle strengthening exercises for the major groups of hip oriented to daily life activities and ends with stretching.
16011780|NCT02798900|Device|Therapeutic Ultrasound|Therapeutic pulsed ultrasound will be applied prior to functional task-training with an intensity of 2.2 W/cm2, frequency of 1 MHz and application time of 4 minutes on the anterior, medial and lateral hip area.
16011781|NCT02798887|Procedure|Ridge preservation|Ridge preservation comparing the clinical and histologic healing with or without a barrier membrane
16011782|NCT02798874|Drug|Ticagrelor|ticagrelor 180 mg 30 min before PCI and 90 mg for 12 months after surgery
16011783|NCT02798874|Drug|Clopidogrel|Clopidogrel 600 mg 30 min before PCI and 75 mg for 12 months after surgery
16011784|NCT02798861|Device|Fibroscan 402/530|Fibroscan 402/530 obtained before procurement in the donor and at 1 to 3 months post-transplant in the liver recipient.
16011785|NCT02798848|Device|Tablet computer|iPad
16011786|NCT02798835|Drug|Adductor canal block|Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal in PACU.
16011787|NCT02798835|Drug|Adductor canal block with dexamethasone|Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine in the adductor canal along with 8mg dexamethasone IV in PACU.
16011828|NCT02798497|Other|Serum and Blood samples|
16011862|NCT02798250|Device|Accu Chek Combo insulin pump|
16011788|NCT02798835|Drug|Adductor canal catheter|Spinal anesthesia with 2-3 ml 0.5% bupivacaine and 0-20mcg of fentanyl. At the end of the case, the surgeon will infiltrate 30ml 0.5% ropivacaine peri-articularly. 20ml 0.5% ropivacaine and a catheter placed in PACU, with a continuous infusion of 0.2% ropivacaine started.
16011789|NCT02798835|Drug|Bupivacaine|Used in spinal anesthetic
16011790|NCT02798835|Drug|Fentanyl|May or may not be used in spinal anesthetic
16011791|NCT02798835|Drug|Ropivacaine 0.5% Injectable Solution|Local anesthetic to be used by surgeon as local infiltration and by anesthesiologist in adductor canal block.
16011792|NCT02798835|Drug|Dexamethasone|To be given intravenously at time of nerve block to one of the study arms.
16011793|NCT02798822|Procedure|Rapid maxillary expansion|When rapid maxillary expander was in-situ, patients waited 7 days before starting the screw activation of one quarter turn a day (0.22 mm) until overcorrection. Expansion was considered adequate when the occlusal surface of the first maxillary palatal cusp contacted the occlusal surface of the mandibular first molar facial cusp. When was achieved, rapid maxillary expander stayed in place for 10 months.
16011794|NCT02798809|Other|Clinical dental examination|Clinical dental examination and a questionnaire that was filled out by the parents before each clinical examination.
16011795|NCT02798796|Device|MRI|All patients will be submitted to MRI
16011796|NCT02798770|Other|No Intervention Foreseen|
16011797|NCT02798757|Drug|Dapagliflozin|Urine samples will be collected for 1HNMR spectroscopies
16011798|NCT02798744|Drug|Empagliflozin|25mg once daily to be taken orally for the duration of the study (24 weeks)
16011799|NCT02798744|Behavioral|Diet|Daily energy restriction diet to be followed for the duration of the study (24 weeks)
16011800|NCT02798744|Drug|Placebo|Placebo once daily for the duration of the study (24 weeks)
16011801|NCT02798718|Dietary Supplement|full-fat milk|intake 250ml full-fat milk per day, do not intake any other dairy products
16011802|NCT02798692|Biological|Low dose HB-101|Three intra muscular administrations at Day 0, Month 1 and Month 3
16011803|NCT02798692|Biological|Medium dose HB-101|Three intra muscular administrations at Day 0, Month 1 and Month 3
16011804|NCT02798692|Biological|High dose HB-101|Three intra muscular administrations at Day 0, Month 1 and Month 3
16011805|NCT02798692|Biological|Placebo|Three intra muscular administrations at Day 0, Month 1 and Month 3. The diluent is used as placebo.
16011806|NCT02798666|Other|High intensity exercise training|Exercise training using sprint interval exercise
16011807|NCT02798666|Other|Continuous exercise training|Exercise training using continuous exercise at constant heart rate
16011808|NCT02798653|Drug|Choriomon® injection|Intramuscular injection of 1,500 IU of hCG (Choriomon®; IBSA) on the embryos transfer (ET) day, as well as 4 days after the embryos transfer for luteal support
16011809|NCT02798653|Drug|Choriomon® injection+Endometrin ®|Intramuscular injection of 1,500 IU of hCG (Choriomon®; IBSA) on the ET day, as well as 3 and 6 days after the transfer along with Endometrin ® vaginal tablets (Ferring Pharmaceuticals Ltd., Germany) 100 mg twice daily for luteal support from the day of oocyte pickup to the day of the pregnancy test.
16011810|NCT02798653|Drug|Endometrin ® vaginal tablets|Endometrin ® vaginal tablets (Ferring Pharmaceuticals Ltd., Germany) 100 mg twice daily for luteal support from the day of oocyte pickup to the day of the pregnancy test.
16011811|NCT02798640|Device|Celliant|100% Celliant garment
16011812|NCT02798640|Device|Control|Control Garment
16011813|NCT02798627|Drug|NS2359|NS2359 is a small molecule which inhibits the reuptake of dopamine, norepinephrine and serotonin with equal affinity.
16011814|NCT02798627|Drug|placebo|Placebo pills identical in appearance to the NS2359 will be provided
16011815|NCT02798614|Device|10-day cast|Removal of plaster cast fixation 10 days after reduction
16011816|NCT02798601|Other|Hypernatremia|Serum Sodium goal: 150 - 155 milliequivalent/L.
16011817|NCT02798588|Radiation|PET-MRI|18Fluoro-Desoxy-Glucose's infusion for PET (glucose neural metabolism assessment, with quantitative information permitted by radioactivity monitoring through arterial catheter ; dosage = 1,5 MBq/Kg + 18,5 MBq as loading dose 5 min= Outside the scanner, Installation and movement management: Curare+/- sedative injection with standardized routine care protocol 10 min= Outside the scanner, Starting PET continuous acquisitionT= 0, Morphological MRI sequences- 3DT1, 3DFlair, T2SE, T2 HR on brainstem, Susceptibility and simple Diffusion Weighted Imaging-Specifically dedicated MR sequences based upon clinical issues 25 min, MRI in Resting state N°1 (global short-term functional connectivity)13 min, MRI DTI acquisition, 64 directions, sensitive to white matter injury 8 min, IRM in 2D-Arterial Spin Labelling:Quantitative Cerebral blood flow information (no Gadolinium)->8 min, IRM in Resting state 2 (repeated occurrence to assess stationarity) 13 min, End of PET continuous acquisition
16011818|NCT02798575|Device|Astral 150 ventilator|Patients indicative for invasive ventilation will receive the Astral 150 ventilator at the weaning station of the hospital. The ventilator will be set by the physician. Afterwards patients will be transferred into home care.
16011819|NCT02798562|Device|Native and dynamic contrast-enhanced CT|
16011820|NCT02798549|Other|blood draw|blood draw of 150ml, twice
16011821|NCT02798536|Drug|LMB-100|Administered IV on days 1, 3 and 5 of a 21 day cycle for up to 4 cycles(Arms A1 and A2) or 2 cycles (Arms B1 and B2)
16011822|NCT02798536|Drug|nab-paclitaxel|Arms B1 and B2 only. Administered IV on days 1 and 8 of each 21 day cycle for up to 6 cycles
16011823|NCT02798523|Drug|Methylprednisolone sodium succinate(Solu-Medrol)|"Methylprednisolone sodium succinate for injection, USP (SOLU-MEDROL sterile powder, Pfizer, Inc.) is an anti-inflammatory glucocorticoid which occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone.
~125-milligram Act-O-Vial (AOV) System: Each 2 mL AOV (when mixed) contains methylprednisolone sodium succinate equivalent to 125 milligrams methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; and 17.4 mg dibasic sodium phosphate dried."
16011824|NCT02798523|Drug|Topical methylprednisolone (Advantan emulsion 0 /1%)|1 g Advantan emulsion 0.1% (Bayer) contains methylprednisolone aceponate (21-acetoxy-11beta-hydroxy-6alpha-methyl-17-propionyloxy-1,4-pregnadiene-3,20-dione) 1 mg, as the active ingredient. It is an oil-in-water emulsion containing medium chain triglycerides, caprylic-capric-stearic triglyceride, polyoxyethylene alcohol 2-stearylether, polyoxyethylene alcohol-21-stearylether, benzyl alcohol, disodium edetate, glycerol, and purified water.
16011825|NCT02798510|Radiation|Concurrent Chemoradiotherapy|
16011829|NCT02798484|Device|Diffusion-weighted Nuclear Magnetic Resonance Imaging (MRI)|MRI examinations performed on two devices: Ingernia 3 Testla (Philips) on the Horta site of the CHU Brugmann hospital, and Area 1,5 Tesla (Siemens) on the Brien site of the CHU Brugmann hospital. Diffusion sequences last 6 minutes and are already performed in the standard of care. Compared to the standard of care, one additional MRI will be performed one month after the start of the neo-adjuvant treatment, with diffusion analysis.The post-processing of the examinations will be realized with the Syngo Onco Care application of Siemens.
16011830|NCT02798471|Drug|Edoxaban|15 or 30 mg tablets for participants 12 years of age to <18, and 60 mg edoxaban suspension for oral administration to participants under 12 years of age
16011831|NCT02798471|Drug|Standard of Care|Standard of care could include low molecular weight heparin (LMWH), vitamin K antagonist (VKA), or synthetic pentasaccharide (SP) Xa inhibitors.
16011832|NCT02798458|Device|Smartpill|The SmartPill Test is approved by the U.S. Food and Drug Administration (FDA) to measure transit time in the GI tract. This procedure uses the SmartPill capsule, a receiver, and computer software.
16011833|NCT02798458|Procedure|Endoscopic Mucosal Resection|a Sigmoidoscopy is an exam used to evaluate the lower part of the large intestine) during which an Endoscopic Mucosal Resection (removal of a small amount of tissue from the outermost layer of gut wall) will be completed.
16011834|NCT02798445|Other|TAPIRS|Terminal Axial Perforator Interruption Reflux Source plus Adjustable compression system
16011835|NCT02798445|Other|CONTROL|Multilayer bandages and wound care
16011836|NCT02798432|Procedure|Total knee arthroplasty|Use of an uncemented femoral component or a cemented femoral component randomly assigned.
16011837|NCT02798432|Device|NEXGEN LPS total knee arthroplasty|Hybrid (non cemented femoral component, cemented tibial component) NEXGEN LPS total knee arthroplasty versus Cemented NEXGEN LPS total knee arthroplasty (both components are cemented).
16011838|NCT02798419|Drug|DFD05 Cream|
16011839|NCT02798419|Drug|Active01 Cream|
16011840|NCT02798406|Biological|DNX-2401|On Day 0, following brain tumor biopsy and confirmation of recurrent tumor, a single injection of DNX-2401 is administered directly into the brain tumor.
16011841|NCT02798406|Biological|pembrolizumab|Sequential intravenous administration every three weeks beginning 7-9 days after Day 0/DNX-2401
16011842|NCT02798393|Other|Infrared Phototherapy|Subjects will wear a cuff on their extremities for a set period of time at set intervals over a period of several weeks. The cuff will emit the Infrared Phototherapy treatment (or sham if randomized to the non-treat group).
16011843|NCT02798393|Other|Sham|
16011844|NCT02798380|Drug|HTS-519 Insert|Maximum feasible dose of HTS-519 Insert per diseased nail
16011845|NCT02798367|Behavioral|CBT-I plus placebo|Behavioral techniques of Sleep Hygiene and Stimulus Control standardized in clinical protocol plus placebo (01 tablet, orally, always at night one hour before bedtime) for 21(±2) days)
16011846|NCT02798367|Drug|CBT-I plus Melatonin 3 mg|Behavioral techniques of Sleep Hygiene and Stimulus Control standardized in clinical protocol plus Melatonin 3 mg (01 tablet, orally, always at night one hour before bedtime) for 21(±2) days.
16011847|NCT02798367|Drug|CBT-I plus Melatonin 5 mg|Behavioral techniques of Sleep Hygiene and Stimulus Control standardized in clinical protocol plus Melatonin 5 mg (01 tablet, orally, always at night one hour before bedtime) for 21(±2) days.
16011848|NCT02798354|Behavioral|Quality Improvement Collaborative|1)Every 8 month 1-2 day interactive webinar learning sessions 2)Monthly webinars sharing best practices 3)Monthly team interactions with dedicated QI coach 4)Monthly data submission on both process and outcome measures 5)Monthly data feedback both at aggregate level with full inter-team transparency as well as at institutional level 6)Monthly mini root cause analyses performed on 1 error at each site 7)Multidisciplinary teams consisting of at least a physician, nurse, and office practice associate 8)Instruction on best practices from content area experts in QI, diagnostic errors, hypertension, mental health, leadership, behavior change, Model for Understanding Success in Quality (MUSIQ) and EHRs 9)Ongoing sharing of best ideas and barriers/issues among institutional teams
16011849|NCT02798341|Other|Biospecimen Collection|
16011850|NCT02798328|Device|TEG6s DOAC Cartridge|Testing subjects for presence of DOAC
16011851|NCT02798302|Other|Flush rate oxygen using a standard flowmeter (Precision Medical, 8MFA). See description for details. This is specific.|A standard oxygen flowmeter will be fully opened and oxygen will be administered for three minutes.
16011852|NCT02798289|Device|Oculeve Intranasal Neurostimulator|Neurostimulation device
16011853|NCT02798276|Procedure|AGTP-treatment|Patients with a myocardial necrosis candidates for revascularization of other myocardial areas, will be enrolled. The non-revascularizable area will be covered with the adipose graft and the revascularizable area will be treated with the normal procedure (by-pass).
16011854|NCT02798276|Other|Control|Patients with a myocardial necrosis, candidates for revascularization of other myocardial areas, will be enrolled. The non-revascularizable area will be left untouched and the revascularizable area will be treated normally (by-pass).
16011855|NCT02798263|Other|Kinesiotherapy|Compare the standard treatment of pain, by kinesiotherapy versus acupuncture and Stiper.Standard therapeutic exercise, pre-defined, based on stretching the neck muscles, shoulder girdle and upper limb exercises for ADM lasting 30 minutes.
16011856|NCT02798263|Other|Acupuncture|30 minutes of classical acupuncture using predefined points.
16011857|NCT02798263|Other|Stiper|They will be used the same acupuncture points of the group II, but using the needles in place Stiper.
16011858|NCT02798250|Other|Dual-hormone closed-loop|Interventions will be undertaken 1 to 5 days after sensor insertion. Subjects will be admitted at the research center at 7:00. Subject's pump will be substituted with the study pump and an additional pump containing glucagon will be installed. At 7:00, closed-loop will be initiated. At 9:00, a standardized breakfast (45g CHO) will be served. Study subjects will consume the same meal on the two intervention days. During the intervention, patients will be allowed to do sedentary activities. Patients will be allowed to consume caffeine during the intervention, but will have to replicate their caffeine consumption on both interventions. The intervention day will end at 13:00.
16011859|NCT02798250|Drug|Insulin|Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra).
16011860|NCT02798250|Drug|Glucagon|Glucagon (Eli Lilly) will be used during dual-hormone closed-loop strategy.
16011861|NCT02798250|Device|Dexcom G4 Platinum glucose sensor|
16011863|NCT02798237|Other|Aerobic treadmill training|"Participants will receive three sessions per week over 12 weeks, in groups of 2-4 participants, by a trained physiotherapist. The duration of the sessions will be 40 minutes (5-10 minutes of warm-up/cool-down and 30 minutes of aerobic treadmill training at 60-80% of heart rate reserve). The training intensity progression will be individualized.
~Before and after the training, participants will remain at rest for 10-15 minutes to measure heart rate, blood pressure and peripheral oxygen saturation (SpO2). The heart rate will be measured continuously during training. Participants will be asked to report any discomfort and to not volunteer to participate in other exercise program. Device: treadmill."
16011864|NCT02798237|Other|Control (overground walking)|Participants will receive three sessions per week over 12 weeks, in groups of 2-4 participants, by a trained physiotherapist. The duration of the sessions will be 40 minutes (5-10 minutes of warm-up/cool-down and 30 minutes of comfortable walking below 40% of heart rate reserve). Before and after the exercise, participants will remain at rest for 10-15 minutes to measure heart rate, blood pressure and peripheral oxygen saturation (SpO2). The heart rate will be measured continuously. Participants will be asked to report any discomfort and to not volunteer to participate in other exercise program
16011867|NCT02798211|Drug|Secukinumab 300 mg|150 mg x 2 s.c. injection
16011868|NCT02798211|Drug|Secukinumab 150 mg|150 mg s.c. injection
16011869|NCT02798211|Other|Placebo|Placebo
16011870|NCT02798198|Other|T2DM|T2DM without DKD
16011871|NCT02798172|Drug|Alogliptin and Metformin|The patients in the control group were given metformin (1,000 mg, bid po) and the patients in the intervention group were given metformin (500 mg, bid po) combined with alogliptin (25 mg, qd po)
16011872|NCT02798159|Drug|TD0025|
16011873|NCT02798159|Drug|Sildenafil Citrate 50mg|
16011874|NCT02798146|Other|blood collection|Blood samples are collected on the following days after human chorionic gonadotropin (hCG) injection: Day 0, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6
16011875|NCT02798133|Procedure|OLA|PEEP titration trial for best Cdyn after the alveolar recruitment maneuver
16011876|NCT02798133|Procedure|RM-5|Fixed standard PEEP after the alveolar recruitment maneuver
16011877|NCT02798120|Drug|SB204 4%|Open label, topical SB204 4%
16011878|NCT02798107|Drug|idarucizumab|drug
16011879|NCT02798081|Behavioral|Single arm study|In Step 1 the elderly will participate of eight conventional computer classes which they were spontaneously enrolled. In Step 2, 10 minutes of the next eight classes will be used to practice serious games using virtual reality, using physical interface (keyboard or mouse).
16011880|NCT02798068|Drug|Solu-medrol or placebo administration|patients will receive 500mg of methylprednisolone in 100ml NaCl 0,9% or placebo (100ml NaCl 0,9%) at anesthesia induction
16011881|NCT02798055|Drug|Bosentan group|
16011882|NCT02798042|Other|Urine Sample|We plan to collect a urine sample during the pre-surgical visit.
16011883|NCT02798029|Radiation|Frameless Fractionated Stereotactic Radiation Therapy|
16011884|NCT02798016|Procedure|Platelet-Rich Plasma|This Platelet-Rich Plasma will be taken from each patient and is going to be used in the treatment of atrophic acne scars
16011885|NCT02798016|Procedure|Micro-needling|Micro-needling will be applied on the acne scars in one side of the face.
16011886|NCT02798003|Other|Functional magnetic resonance imaging (fMRI)|The food-cue elicited response in the reward-circuitry of the brain will be assessed by using fMRI. This technique is based on different magnetic properties of oxygenated and deoxygenated blood. Increased neuronal activity causes an increase in blood flow. Thereby, neuronal activity is indirectly reflected by changes in blood oxygenation level-dependent (BOLD) contrast.
16011887|NCT02797977|Drug|SRA737, gemcitabine, cisplatin|
16011888|NCT02797977|Drug|SRA737, gemcitabine|
16011889|NCT02797964|Drug|SRA737|SRA737 will be administered orally on each day of a 28-day cycle. Subjects will receive a single dose of SRA737 between 4 to 7 days prior to starting the first cycle for PK profiling. Subjects can continue taking SRA737 if they are receiving clinical benefit and able to safely take the drug and follow the requirements of the study.
16011890|NCT02797951|Drug|Galcanezumab|Administered SQ
16011891|NCT02797938|Device|Taper guard tube|Taper guard tube was intubated
16011892|NCT02797938|Device|Cylindrical tube|Cylindrical tube was intubated
16011893|NCT02797925|Other|Training|Long slow strength training of the tendon for 3 months to improve function
16011894|NCT02797912|Other|No intervention|
16011895|NCT02797899|Device|Platelet Rich Fibrin|Native growth factors
16011896|NCT02797886|Other|FES + VOL|Electrical stimulation is applied in concert with the subject's volitional movement.
16011897|NCT02797886|Other|FES|Electrical stimulation is applied to the subject while they are asked to do nothing.
16011898|NCT02797886|Other|VOL|The subject initiates and completes the movement without electrical stimulation.
16011899|NCT02797873|Other|fMRI - Stroop task|2 x 10 minutes Stroop task (2 x 5 minutes emotional blocks, 2 x 5 minutes non-emotional blocks, order balanced across participants) performed during fMRI scan. See Detailed Study Description.
16011900|NCT02797873|Other|fMRI - MID task|2 x 10 minutes MID task performed during fMRI scan. See Detailed Study Description.
16011901|NCT02797873|Behavioral|Stop Signal Task|Performed at a computer at first visit, 10 minutes divided into 3 blocks. See Detailed Study Description.
16011902|NCT02797873|Other|SCID-II|See Detailed Study Description.
16011903|NCT02797873|Other|SDQ|See Detailed Study Description.
16011904|NCT02797873|Other|ASRS|See Detailed Study Description.
16011905|NCT02797873|Other|AQ|See Detailed Study Description.
16011906|NCT02797873|Other|TAS-20|See Detailed Study Description.
16011907|NCT02797873|Other|Raven's SPM|See Detailed Study Description.
16071171|NCT02374567|Drug|Acamprosate|
16011908|NCT02797873|Other|Reading ability|See Detailed Study Description.
16011909|NCT02797873|Other|Ishihara's tests for colour deficiency|See Detailed Study Description.
16011910|NCT02797873|Other|Additional questionnaire|including questions about somatic disease, current medication, BMI, smoking habits, first menstruation, last menstruation's first day, days without active oral contraceptive pill during last month, claustrophobia, vision impairment.
16011911|NCT02797873|Other|Brown-ADD|See Detailed Study Description.
16011912|NCT02797873|Other|MFQ|See Detailed Study Description.
16011913|NCT02797873|Other|STAI-T|See Detailed Study Description.
16011914|NCT02797873|Other|BIS|See Detailed Study Description.
16011915|NCT02797873|Other|DAWBA|See Detailed Study Description.
16011916|NCT02797873|Other|STAI-S|See Detailed Study Description.
16011917|NCT02797873|Other|Sleepiness rating|Acquired 6 times while in MRI-scanner. See Detailed Study Description.
16011918|NCT02797873|Other|Motivation rating|Acquired 6 times while in MRI-scanner. See Detailed Study Description.
16011919|NCT02797873|Behavioral|FEFA2|Assessing ability to recognise emotional face, performed at a computer at first visit. See Detailed Study Description.
16011920|NCT02797873|Other|Structural T1 MRI scan|See Detailed Study Description and Outcome Measures.
16011921|NCT02797873|Other|Structural T2 MRI scan|See Detailed Study Description.
16011922|NCT02797873|Other|DTI MRI scan|See Detailed Study Description and Outcome Measures.
16011923|NCT02797873|Other|Resting state MRI scan|See Detailed Study Description and Outcome Measures.
16011924|NCT02797860|Drug|Rocuronium|comparison of onset time and duration of rocuronium using Train of Four watch
16011925|NCT02797847|Drug|ALN-TTRSC02|Ascending doses of ALN-TTRSC02 by subcutaneous (SC) injection
16011926|NCT02797847|Drug|Sterile Normal Saline (0.9% NaCl)|Calculated volume to match active comparator
16011927|NCT02797834|Procedure|Endometrial fluid collection|
16011928|NCT02797821|Drug|Asfotase alfa|
16011929|NCT02797808|Drug|Sertraline|Impact of sertraline on functional brain connectivity
16011930|NCT02797808|Other|No Intervention|Healthy control non-intervention
16011931|NCT02797795|Drug|NEV801|Dose Escalation
16011932|NCT02797782|Other|Detection of anti HBs antibody titer|All samples will be analyzed for anti HBs antibody titer using ELISA kits.
16011933|NCT02797769|Drug|Other Biologics|Exposure data will be gathered from claims databases, and no medicine will be administered in this non-interventional study. There are no protocol-specified biologic agents, although the analyses will be stratified by TNFi and non-TNFi targeted therapies. The drug selection and regimen are at the discretion of the prescribing physician.
16011934|NCT02797769|Drug|Tocilizumab|Tocilizumab exposure data will be gathered from claims databases, and no medicine will be administered in this non-interventional study. The regimen is at the discretion of the prescribing physician.
16011935|NCT02797756|Procedure|Esophago-gastro-duodenoscopy (EGD) with biopsy|
16011936|NCT02797756|Procedure|Esophageal Impedance Monitoring (EIM)|
16011937|NCT02797743|Other|Whole blood|"Adults ≥18 yrs of age: up to 50 mL (5 tubes)
~Adolescents 12-17 yrs of age: up to 30 mL (3 tubes)
~Children 0-11 yrs of age: single tube (1 tube, 10 mL)"
16011938|NCT02797730|Behavioral|art-therapy sessions|
16011939|NCT02797717|Radiation|Radiotherapy:|"All patients will have 2 OPEAcycles(chemotherapy cycle:Vincristine,Etoposide,Prednisone,doxorubicin) ,After assignment ( by randomization) to one of the arms the patient will be treated accordingly . response assessment will be done after OPEA cycles (ERA) and after cycles of copdac 28 or DECOPDAC 21(LRA).according to the assessments results patients will have radiotherapy or not."
16011940|NCT02797717|Drug|Vincristine|ARM A and ARM B
16011941|NCT02797717|Drug|Etoposide|ARM B , 100mg/m2/day
16011942|NCT02797717|Drug|Prednisone|ARM A and ARM B , 40mg/m2/day p.o
16011943|NCT02797717|Drug|Doxorubicin|ARM B , 25mg/m2
16011944|NCT02797717|Drug|Dacarbazine|ARM A and ARM B , 250mg/m2 i.v
16011945|NCT02797717|Drug|Cyclophosphamide|ARM A and ARM B , 625mg/m2 i.v
16011946|NCT02797704|Drug|Aflibercept|Eylea (aflibercept) Injection is a prescription medicine administered by injection into the eye.
16011947|NCT02797691|Other|CaCBT|Culturally Adapted Cognitive Behaviour Therapy
16011948|NCT02797691|Other|Medication/ Psychotherapy|Medication/ Psychotherapy used as usual
16011949|NCT02797678|Device|Powersleep|Participants will receive 5 nights of stimulation
16011950|NCT02797678|Device|Sham Powersleep|Participants will receive 5 nights of no stimulation
16011951|NCT02797665|Drug|corticosteroids|prednisone 0.6mg/kg/d
16011952|NCT02797665|Procedure|biliary stent|placement of biliary stent during endoscopic retrograde cholangiopancreatography (ERCP)
16011953|NCT02797652|Procedure|Neoadjuvant chemotherapy before surgery|The operable breast cancer patients takes neoadjuvant chemotherapy before surgery.
16011954|NCT02797652|Procedure|Surgery followed by adjuvant chemotherapy|The operable breast cancer patients takes surgery followed by adjuvant chemotherapy.
16011955|NCT02797639|Other|Co-PID|"The program was carried out by the school occupational therapist and homeroom teachers. The Co-PID had two phases. The first phase was a 1.5 hour in-service meeting that focused on the concept of Participation.
~In the second phase of the Co-PID intervention, a collaborative consultation model was used. It included eight 45-minute consultation meetings, which took place every other week over a 3-months period. The meetings took place between the occupational therapist and each teacher, with the purpose of brainstorming; thinking of activities that the teacher could implement during the lessons for enhancing participation among the students."
16011956|NCT02797639|Other|IS|IS group included three meetings, a 1.5 hour in-service meeting focusing on the concept of participation, and two more workshop meetings aimed at sharing teachers' experience.
16011957|NCT02797626|Procedure|Primary retroperitoneal lymph-node dissection (pRPLND)|Open or laparoscopic robotic-assisted nerve-sparing retroperitoneal lymph node dissection (modified template RPLND, if possible ipsilateral nerve-sparing)
16011958|NCT02797613|Behavioral|Restricted Reporting|An abbreviated version of the microbiology report indicating that growth is present and the physician should call the lab for further details if clinically important
16012039|NCT02797041|Drug|Bortezomib|Re-challenge with bortezomib as second line therapy in myeloma patients relapsed after a previous bortezomib-based treatment
16011959|NCT02797600|Behavioral|Questionnaires|Questionnaires will be used to obtain self-reported demographic, behavioral, social, family and medical history, and quality of life data. The questions are standardized and taken from either nationally recognized surveys, CARE I surveys, or represent validated survey items.
16011960|NCT02797600|Other|Biological Samples|All biological samples will be collected at the time of the clinical Pap smear for the controls, and will be collected for the Arm 2 (newly diagnosed) during a scheduled clinic visit. For those individuals in Arm 1, biological samples will be collected during a scheduled visit with the research staff.
16011961|NCT02797587|Drug|Varenicline|1 week starter kit followed by 1mg twice daily for 12 weeks.
16011962|NCT02797587|Drug|Cytisine|Multi-daily dosing, range 3-9 mg daily for 25 days.
16011963|NCT02797587|Drug|Nicotine Replacement Therapy|Mouth spray dosing based on standard recommendations tapered over 8 weeks.
16011964|NCT02797587|Drug|Varenicline Placebo|1 week starter kit followed by 1 pill twice daily for 12 weeks.
16011965|NCT02797587|Drug|Cytisine Placebo|Multi-daily dosing for 25 days.
16011966|NCT02797587|Drug|Nicotine Replacement Therapy Placebo|Mouth spray dosing based on standard recommendations tapered over 8 weeks.
16011967|NCT02797574|Procedure|Punch Biopsy at a Lesional Site|
16011968|NCT02797574|Procedure|Punch Biopsy at a Non- Lesional site|
16011969|NCT02797561|Other|5 year Follow-up|
16011970|NCT02797548|Drug|Aspirin only|Aspirin only during surgery
16011971|NCT02797548|Drug|No antiplatelet therapy|No antiplatelet therapy will be during surgery
16011972|NCT02797535|Procedure|Endoscopy procedures|GI fluids samples will be collected from: (i) fluids suctioned during standard endoscopy procedures / pouchoscopy, (ii) from ileostomy/colostomy bags removed for bag replacement and (iii) from stool samples collected by patients after pouch surgery.
16011973|NCT02797522|Drug|ARC-521 Injection|
16011974|NCT02797522|Other|Placebo|0.9% normal saline
16011975|NCT02797522|Drug|antihistamine|Approximately two hours prior to ARC-521 or placebo administration, participants will be pre-treated with an oral antihistamine, selected by the investigator from the list of approved antihistamines that is available in that country. Approved antihistamines are: diphenhydramine 50 mg by mouth (PO), chlorpheniramine 8 mg PO, or hydroxyzine 50 mg PO.
16011976|NCT02797522|Drug|acetaminophen|Approximately two hours prior to ARC-521 or placebo administration, participants will be pre-treated with acetaminophen (500 - 1000 mg PO, per local strength availability).
16011977|NCT02797522|Drug|entecavir|Participants take entecavir OR tenofovir daily throughout the study.
16011978|NCT02797522|Drug|tenofovir|Participants take entecavir OR tenofovir daily throughout the study.
16011979|NCT02797509|Behavioral|Psychosocial Skills-Based Intervention|Subjects will attend group skills-based sessions once weekly (either in-person or via Vidyo) for 6 weeks and learn skills to cope and manage stroke-related stressors.
16011980|NCT02797496|Other|Asymmetric Motor Strengthening|"In the Asymmetric Motor Strengthening program, the principle is to concomitantly reinforce the body openers and stretch the body closers. One alternates two types of practice during a session. Active exercises consist of fatiguing series of rapid alternating movements against light weights working on movements of extension/abduction/external rotation/supination. Stretch postures consists of short 1-2 minutes bouts of flexor/internal rotator/adductor/pronator stretch. The duration of rehabilitation program is 8 weeks."
16011981|NCT02797496|Other|Conventional therapy|Conventional therapy will include general stretch, strengthening and balance exercises, respiratory exercises and relaxation methods.
16011982|NCT02797483|Other|Test Fat Blue|Each subject received a palm olein-based run in diet for 2 weeks, followed by random assignment Test Fat Blue which incorporated into daily snacks (~50g of test fats, 2 experimental cupcakes (~15g test fat each) for breakfast and 4 pieces experimental cookies (~5g test fat each) for afternoon tea together with a palm olein-based background diet for 16 weeks.
16011983|NCT02797483|Other|Test Fat Green|Each subject received a palm olein-based run in diet for 2 weeks, followed by random assignment Test Fat Green which incorporated into daily snacks (~50g of test fats, 2 experimental cupcakes (~15g test fat each) for breakfast and 4 pieces experimental cookies (~5g test fat each) for afternoon tea together with a palm olein-based background diet for 16 weeks.
16011984|NCT02797483|Other|Test Fat Red|Each subject received a palm olein-based run in diet for 2 weeks, followed by random assignment Test Fat Red which incorporated into daily snacks (~50g of test fats, 2 experimental cupcakes (~15g test fat each) for breakfast and 4 pieces experimental cookies (~5g test fat each) for afternoon tea together with a palm olein-based background diet for 16 weeks.
16011985|NCT02797470|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells
16011986|NCT02797470|Drug|Carmustine|300 mg/m2 on Day -6, as part of BEAM and R-BEAM regimens.
16011987|NCT02797470|Drug|Cytarabine|100 mg/m2 BID on Days -5 through -2, as part of BEAM and R-BEAM regimens.
16011988|NCT02797470|Drug|Etoposide|VP-16: 100 mg/m2 BID on Days -5 through -2, as part of BEAM and R-BEAM regimens.
16011989|NCT02797470|Other|Laboratory Biomarker Analysis|Correlative studies
16011990|NCT02797470|Biological|Lentivirus Vector CCR5 shRNA/TRIM5alpha/TAR Decoy-transduced Autologous CD34-positive Hematopoietic Progenitor Cells|Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells
16011991|NCT02797470|Drug|Melphalan|140 mg/m2 on Day -1, as part of BEAM and R-BEAM regimens.
16011992|NCT02797470|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo infusion of lentivirus vector CCR5 shRNA/TRIM5alpha/TAR decoy-transduced autologous CD34-positive hematopoietic progenitor cells
16011993|NCT02797457|Procedure|Bilateral allograft of the hands and forearms.|Bilateral allograft of the hands and forearms.
16011994|NCT02797457|Procedure|Prosthetic forehands|Prosthetic forehands
16011995|NCT02797444|Other|semi-structured interviews|
16011996|NCT02797431|Drug|Interleukin-7|IM administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR>2.5 or platelet count < 35,000
16011997|NCT02797431|Drug|Placebo|IM administration of Placebo (SC administration for patients with INR>2.5 or platelet count < 35,000
16012040|NCT02797028|Dietary Supplement|Anthocyanidins capsule|Continuous intervention for 1 years, detect the indicators in the intervention of 0,6,12 months
16011998|NCT02797418|Behavioral|Cognitive remediation program|"Comparison between a cognitive remediation program (Cognitus and Me) (groupe 1) and a training group of fine motor skills (group 2)"
16011999|NCT02797405|Radiation|Standard treatment|Sarcoma patients will undergo radiotherapy followed by surgery Rectum cancer patients will undergo radio-chemotherapy followed by surgery Esophagus cancer patients will undergo radio-chemotherapy followed by surgery
16012000|NCT02797392|Behavioral|Lifestyle intervention|1) Systematic collection of information on lifestyle risk factors using questionnaire 2) Risk estimation and stratification into risk groups based on questionnaire data and information from the electronic patient record (EPR) using validated risk estimation models, 3) An individual electronic health profile with personalized advise on lifestyle change and 4) targeted preventive services incl. lifestyle counseling at the GP or the municipality for citizens at increased risk of lifestyle disease and citizens with risk behavior, respectively.
16012001|NCT02797379|Other|Psychoeducation|The intervention is focused on psychoeducation. Four psychoeducation guides will be available: parent/caregiver, adult with ASD, adolescent with ASD, and child with ASD. The guides introduce the concept of anxiety and how it presents in individuals with ASD, different anxiety triggers, strategies that can be used to manage anxiety, and an introduction to specific anxiety disorders. Level of detail, language and presentation of content will vary across the guides to be appropriate for the functioning level of the readers.
16012002|NCT02797366|Radiation|Proton radiotherapy|
16012003|NCT02797353|Other|Maternal Neonatal and Child Health Interventions|Antenatal care, postnatal care, skilled birth attendance, recognition and referral of complicated cases, immunization
16012004|NCT02797340|Other|Blood draws and urine samples for metformin concentration measurements|
16012005|NCT02797340|Drug|Metformin|
16012006|NCT02797314|Other|Bone biopsies|Bone biopsies
16012007|NCT02797301|Other|synthetic test|The children performed the synthetic test with no time restriction.
16012008|NCT02797301|Other|computerised test|The children performed the computerised test with no time restriction.
16012009|NCT02797275|Drug|Albuterol|Beta agonist respiratory inhaler
16012010|NCT02797275|Drug|Placebo|respiratory inhaler with no medication
16012011|NCT02797262|Device|Proteus digital health feedback (PDHF) system|Building on the available Proteus devices, the investigators will design and create a PDHF system to transmit the adherence data using mobile technology to allow treatment monitoring that is, direct confirmation of the type, dose, date and time of oral pharmaceutical ingestion using wirelessly observed therapy (WOT).
16012012|NCT02797249|Drug|Aspirin|Low dose aspirin（100mg）per day starting between 12+ and 20 weeks of pregnancy until 34 weeks of pregnancy,taking at night.
16012013|NCT02797249|Other|Blank|Routine examination during pregnancy.
16012014|NCT02797236|Biological|SF2a-TT15 vaccine|
16012015|NCT02797236|Biological|SF2a-TT15 vaccine + adjuvant|
16012016|NCT02797236|Biological|Placebo|
16012017|NCT02797236|Biological|Placebo + adjuvant|
16012018|NCT02797223|Behavioral|Semi-structured interviews|Qualitative phenomenological study. Data collection will be done through semi-structured interviews. Each interview will last between 60 and 90 minutes. It will be the same researcher who interviewed and analyze them.
16012019|NCT02797210|Device|Continuous theta-burst stimulation|
16012020|NCT02797197|Procedure|handgrip strength test|
16012021|NCT02797197|Drug|chemotherapy|
16012022|NCT02797184|Drug|KNO3, potassium nitrate|Potassium nitrate (KNO3) will be given orally in 2 gelatin capsules, which will be compounded by the Barnes-Jewish Hospital Pharmacy. The doses are 10 mmol and 20 mmol KNO3.
16012023|NCT02797171|Biological|VRC01|Administered by intravenous (IV) infusion
16012024|NCT02797171|Biological|VRC01LS|Administered by intravenous (IV) infusion
16012025|NCT02797158|Procedure|TAVI procedure|Targeted and selected revascularization guided on myocardial ischemia detection after the TAVI procedure by using single photon emission computed tomography (SPECT) myocardial perfusion imaging.
16012026|NCT02797145|Drug|Digoxin dose-adjusted|Serum digoxin concentration : 0.5 to 0.9 nanogram/mL
16012027|NCT02797145|Drug|Standard dose|the dose of digoxin will be determined at the physician's discretion using traditional dosing methods.
16012028|NCT02797132|Drug|LUM/IVA|
16012029|NCT02797119|Drug|tranexamic acid 1 g (TA1)|1 g standard dose tranexamic acid, intravenous unique bolus over 1 minute
16012030|NCT02797119|Drug|tranexamic acid 0.5 g (TA1/2)|0.5 g standard dose tranexamic acid, intravenous unique bolus over 1 minute
16012031|NCT02797119|Drug|Saline Solution (TA0)|
16012032|NCT02797106|Other|Practice survey of health professionals|Survey of the practices and opinions of health care professionals to describe care pathways, assessment and treatment of drooling in children with cerebral palsy
16012033|NCT02797080|Drug|interferon γ-1b|ACTIMMUNE® will be administered three times per week by subcutaneous injection. The initial dose will be individualized for each participant and will be determined by the investigator, provided that the initial dose does not exceed the maximum tolerated dose in HZNP-ACT-302 (NCT02593773). The investigator may subsequently adjust the dose for any participant if deemed clinically appropriate, provided that the dose does not exceed 100 μg/m².
16012034|NCT02797067|Drug|indomethacin suppository|100mg rectal indomethacin 30min before ESWL
16012035|NCT02797067|Drug|Glycerin Suppository|30min before ESWL
16012036|NCT02797054|Behavioral|Tailored educational materials|The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented.
16012037|NCT02797054|Behavioral|Untailored educational materials|"The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV Vaccine Information Sheet that has been created by the Centers for Disease Control and Prevention."
16012038|NCT02797054|Behavioral|Usual care|Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.
16012084|NCT02796677|Drug|Formoterol fumarate 12 μg (FF 12 μg)|Inhalation powder
16012041|NCT02797028|Dietary Supplement|Placebo capsule|Continuous intervention for 1 years, detect the indicators in the intervention of 0,6,12 months
16012042|NCT02797028|Drug|Allopurinol|Continuous intervention for 1 years, detect the indicators in the intervention of 0,6,12 months
16012043|NCT02797015|Drug|RPC1063|Oral capsule daily
16012044|NCT02797002|Other|Assessment|
16012045|NCT02796989|Dietary Supplement|Wheat bran|20 g each day
16012046|NCT02796989|Dietary Supplement|Placebo|20 g each day
16012047|NCT02796976|Other|Training or control condition|Participants get a 12 week high intensity and walking-based interval training which is adapted to their individual physical fitness level or a general recommendation on physical activity according to European Guidelines.
16012048|NCT02796963|Behavioral|Crowdsourced intervention|The crowdsourced intervention is composed of three phases that cumulatively draw on crowd wisdom to engage the community: (1) a crowdsourcing contest to solicit optimal images/concepts/taglines; (2) a designathon to formulate optimal HIV testing campaigns; (3) a process of localization unique to each of the eight cities.
16012049|NCT02796963|Behavioral|Traditional intervention campaign|The pre-intervention period will include conventional HIV testing campaigns organized by local CDC, Community-Based Organization (CBO), and partners. These are typically designed by experts and social marketing companies.
16012050|NCT02796950|Drug|Acipimox|P.o. administration of 250 mg acipimox
16012051|NCT02796937|Biological|Alpha-1 MP|Alpha-1 MP 60 mg/kg/week for up to 104 weeks
16012052|NCT02796924|Device|MagStim Rapid2 Transcranial Magnetic Simulation|A non-invasive method of brain stimulation
16012053|NCT02796911|Drug|Xenograft|group II will be treated with CAOT combined with bovine derived xenograft (Biogen, Biotecksrl Fermi, Arcugraro VI, Italy);
16012054|NCT02796911|Drug|Bioactive glass|group III will be treated with CAOT combined with bioactive glass (Bio-Glass, Excellence Pharm Inc., Egypt).
16012055|NCT02796898|Drug|SM88 (Cohort 1)|"Tyrosine Isomers - 230 mg qd
~Phenytoin - 50 mg qd.
~Methoxsalen - 10 mg qd
~Sirolimus - 0.5 mg qd"
16012056|NCT02796898|Drug|SM88 (Cohort 2)|"Tyrosine Isomers - 460 mg (230 mg bid)
~Phenytoin - 50 mg qd
~Methoxsalen - 10 mg qd
~Sirolimus - 0.5 mg qd"
16012057|NCT02796885|Other|no intervention - observational study|
16012058|NCT02796872|Dietary Supplement|GOS|GOS resource (β-galactosidase from Bacillus circulans) Commercial infant formula containing 4% w/w FOS:GOS (1:3)
16012059|NCT02796872|Dietary Supplement|B-GOS 3%|Bimuno-GOS (B-GOS) resource (β-galactosidase from Bifidobacteriumbifidum) Commercial infant formula containing 3% w/w FOS:B -GOS (1:2)
16012060|NCT02796872|Dietary Supplement|B-GOS 2%|Bimuno-GOS (B-GOS) resource (β-galactosidase from Bifidobacteriumbifidum) Commercial infant formula containing 4% w/w FOS:B -GOS (1:3)
16012061|NCT02796872|Dietary Supplement|Mother's breast milk|exclusively breastfed infants for at least 7 days prior to enrollment
16012062|NCT02796859|Drug|Siltuximab|Investigational agent
16012063|NCT02796859|Drug|normal saline|Placebo
16012064|NCT02796833|Drug|SMOFlipid20%|
16012065|NCT02796820|Drug|Huaier Granule|Huaier Granule is continuously taken three times per day, 20g per time.
16012066|NCT02796807|Drug|68Ga-HBED-CC-PSMA (DKFZ-11) PET/CT|
16012067|NCT02796794|Dietary Supplement|Genistein|Total 30 patients will be included into the study They will be divided into two groups each containing 15 patients. Intervention group will receive supplemental genistein (60 mg/day) to enteral nutrition
16012068|NCT02796794|Other|enteral nutrition only|These are the patients receiving enteral nutrition
16012069|NCT02796781|Biological|Lung stem cells|
16012070|NCT02796768|Other|3D US Scanning|3D ultrasound will be used by both clinicians to scan both the right and left hips of the infant.
16012071|NCT02796768|Other|2D US Scanning|2D ultrasound will be used by both clinicians to scan both the right and left hips of the infant.
16012072|NCT02796755|Drug|Riluzole|Study participants randomized to this arm will take 100 mg/day of riluzole for 8 weeks.
16012073|NCT02796755|Drug|Placebo|Study participants randomized to this arm will take a placebo, that matches the appearance of 100 mg tablets of riluzole, daily for 8 weeks.
16012074|NCT02796742|Other|Collecting samples from all patients presenting with SSTIs requiring drainage|The study will be conducted by microbiology laboratories. Before the start of the study, each participating laboratory will send an information letter to its corresponding emergency departments to increase vigilance of clinicians in collecting samples from all patients presenting with SSTIs; this will improve the level of inclusion. Each participating lab will also insure connection to local representation of the project for ethical clearance, collection of clinical data and SSTI specimen.
16012075|NCT02796729|Procedure|Magnetic resonance imaging|MRI offers excellent images of the brain and is an important tool for diagnosing metastatic brain tumors. MRI scans are often used to plan treatments such as surgery and radiotherapy. When imaging participants with metastatic brain tumors, a contrast agent is often injected intravenously to highlight the relatively small tumours in the MRI. The standard metal-based MRI contrast agent is Health Canada approved and contains a material called gadolinium. MRI studies that use gadolinium-based contrast agents are called gadolinium enhanced MRI.
16012076|NCT02796729|Drug|Gadovist (Gadobutrol)|Gadobutrol (INN) (Gd-DO3A-butrol) is a gadolinium-based MRI contrast agent (GBCA).
16012077|NCT02796729|Drug|50% dextrose solution|50% Dextrose Injection, USP is a sterile, nonpyrogenic, hypertonic solution of dextrose in water for intravenous injection.
16012078|NCT02796716|Device|Testing on new technology called Accelerate ID/AST system|
16012079|NCT02796703|Dietary Supplement|Heat Inactivated probiotics|Biotikid, a probiotic mixture, will be heated to 100 degrees Centigrade for 10 minutes to inactivate and then 1 tsp will be diluted in milk and give with feeds to treatment group
16012080|NCT02796703|Dietary Supplement|Placebo|2 cc of milk will be given to control group
16012081|NCT02796690|Other|nasal swabs will be collected|After formal consent, nasal swabs are collected for each participant. SA nasal carriage and its susceptibility to methicillin is determined using a rapid PCR technique (GenExpert, Cepheid). Each participant is asked to complete a short questionnaire regarding some demographic variables, smoking habits, long-term medication, sector of activity, and direct manipulation of the pathogen.
16012082|NCT02796677|Drug|Aclidinium bromide 400 μg/Formoterol Fumarate 12 μg (AB/FF 400/12 μg)|Inhalation powder
16012083|NCT02796677|Drug|Aclidinium bromide 400 μg (AB 400 μg)|Inhalation powder
16012085|NCT02796677|Other|Placebo to AB/FF 400/12 μg, AB 400 μg and FF 12 μg|Inhalation powder
16012086|NCT02796677|Drug|Tiotropium 18 μg (TIO 18 μg)|Powder in capsules for oral inhalation
16012087|NCT02796677|Other|Placebo to TIO 18 μg|Powder in capsules for oral inhalation
16012088|NCT02796664|Dietary Supplement|Ginseng|Korean Red Ginseng extract tablet (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
16012089|NCT02796664|Dietary Supplement|Placebo|Placebo (0.5 grams/tablet, 2 tablets twice a day) daily for 12 months.
16012090|NCT02796651|Drug|Formoterol fumarate (6 μg)|Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI)
16012091|NCT02796651|Drug|Formoterol furmarate (20 μg)|Oral Inhalation (via a standard jet nebulizer connected to an air compressor.
16012092|NCT02796651|Drug|Placebo for formoterol fumarate|Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI)
16012093|NCT02796651|Drug|Formoterol fumarate (12 μg)|Oral Inhalation (by Pressair® Dry Powder Inhaler, DPI)
16012094|NCT02796651|Drug|Formoterol fumarate (40 μg)|Oral Inhalation (via a standard jet nebulizer connected to an air compressor.
16012095|NCT02796638|Device|Adaptive Servo-Ventilation|A positive pressure airway device that increases and decreases inspiration pressure in concordance with the patient's natural breathing cycles.
16012096|NCT02796625|Other|Painful Stimuli|warm or painful heat administration
16012097|NCT02796612|Other|no intervention|Patients do not receive any interventions but are treated according to current standard of care.
16012098|NCT02796612|Behavioral|delivery of a take-home brochure|Content of brochure is dealing with symptoms, as well as mammographic and ultrasound findings, which need further investigation, will be addressed. The procedure of the breast biopsy itself will be explained in detail. The time in which the histological diagnosis can be expected will be indicated and follow up in case of a benign histology and the necessary therapy in case of breast cancer will be addressed.
16012099|NCT02796612|Behavioral|patient care by a psychologically trained physician|The physicians who perform the biopsies will be instructed by means of a psychological training how to give structured and standardized information in order not only to inform comprehensively, but also to meet the patients' emotional needs.
16012100|NCT02796599|Device|Non invasive ventilation during exercise with facial or nasal mask.|Every patients will achieve 3 constant work load test (CWLT) at 75% Wpic. The first CWLT will be realized without any ventilatory support. The 2 others CWLT will be achieved with non-invasive ventilation support using facial or nasal interface in a randomized order.
16012101|NCT02796586|Other|Counseling|Participants will be randomly assigned to group versus individual contraceptive counseling
16012102|NCT02796573|Behavioral|cognitive behavioural therapy|
16012103|NCT02796560|Drug|Brand name travoprost|Depending on the arm, either brand name or generic Travoprost will be administered by the patient. After 3 weeks, the intraocular pressure will be measured and a crossover will happen. Patients having taken brand name Travoprost will be switched to generic Travoprost and vice versa. At 6 weeks, the intraocular pressure will be measured. Questionnaires on the comfort and intolerances of the drops will be administered at the visits of 3 and 6 weeks.
16012104|NCT02796560|Drug|Generic travoprost|Depending on the arm, either brand name or generic Travoprost will be administered by the patient. After 3 weeks, the intraocular pressure will be measured and a crossover will happen. Patients having taken brand name Travoprost will be switched to generic Travoprost and vice versa. At 6 weeks, the intraocular pressure will be measured. Questionnaires on the comfort and intolerances of the drops will be administered at the visits of 3 and 6 weeks.
16012105|NCT02796547|Drug|Levobupivacaine|Infiltration of the banks of the episiotomy done with Levobupivacaine
16012106|NCT02796547|Other|Physiological serum|Infiltration of the banks of the episiotomy done with physiological serum
16012107|NCT02796534|Other|Diagnosis of sleep apnea by oxymetry|
16012108|NCT02796521|Other|dietary counseling|Patients received individualized nutritional counseling encouraging them for enrichment
16012109|NCT02796521|Other|nutritional workshop with enrichment during a meal|Patients received in group nutritional informations for enrichment and are encouraged to try enrichment together during a meal.
16012110|NCT02796508|Behavioral|Experimental: Non-action video game training|PSI2013-41409R. Effects of video game training on behavioral and neuroimaging measures of attention and memory
16012111|NCT02796508|Behavioral|Active Comparator: Non-cognitive video game training|16 training sessions with The Sims over 8-10 weeks in small groups
16012112|NCT02796495|Device|Operation of hand prosthesis with direct nerve stimulation|"Four TIME-4H electrodes will be implanted in the median and ulnar nerves of the amputees. The electrodes will be connected with the STIMEP electrical multichannel stimulator. The stimulator will be connected with one of the two sensorized hand prosthesis. Afferent and efferent signals will be elaborated and integrated by the ODROID software.
~The amputees will be able to control the prosthetic hand movement and receive a sensory feedback from the prosthesis sensors.
~The use of the prosthesis during different tasks will be considered the intervention."
16012113|NCT02796482|Dietary Supplement|EnergieShake 1.5kcal Complete|Participants will be given EnergieShake 1.5 kcal Complete drink twice daily. i.e. 2 bottles of ONS per day during the study period in place of their usual ONS. Participants will take their usual ONS for 2 days, followed by 8 day intervention on EnergieShake 1.5 kcal Complete drink.
16012114|NCT02796469|Drug|Pentoxifylline|
16012115|NCT02796469|Drug|Corticosteroid|
16012116|NCT02796469|Drug|Placebo|
16012117|NCT02796456|Other|blood sample|
16012118|NCT02796443|Procedure|Laparoscopic cholecystectomy (LC)|Removal of the gallbladder via a minimally invasive approach
16012119|NCT02796430|Other|Time needed to start indirect calorimetry measurement|Comparison of the time needed to start EE measurements by the new calorimeter and the currently used calorimeter, including the time needed for calibration, patient data input, connection to the ventilator circuit.
16012120|NCT02796430|Other|Indirect calorimetry measurement|Comparison of EE measurements by the new calorimeter and the currently used calorimeter when using different mechanical ventilators, different ventilation modes, different patient conditions and severity
16012157|NCT02796157|Device|PCI with Xience everolimus-eluting metallic stent|Patients allocated to this arm will undergone PCI with Xience everolimus-eluting metallic stent. It will be allowed to used multiple stents for a long coronary lesion.
16012158|NCT02796144|Drug|Lorcaserin|Max dose of 10 mg BID
16012121|NCT02796417|Behavioral|REHACOP|REHACOP group consists of 90-minute-long sessions 3 days per week. Specifically, REHACOP group remediation consisted of: Attention unit (4 weeks) training sustained, selective, alternant and divided attention; Memory unit (3 weeks) focusing on visual and verbal learning, recall and recognizing memory; Language unit (3 weeks) including grammar, syntax, vocabulary, verbal fluency, verbal comprehension, abstract language; Executive functions unit (2 weeks) training cognitive planning, proverbs, analogies; and Social cognition unit (1 week) exercising theory of mind, social reasoning and moral dilemmas
16012122|NCT02796417|Behavioral|Occupational activities|Occupational group activities conducted included drawing, gardening, reading the daily news and constructing using different materials (such as paper or wood).
16012123|NCT02796404|Device|Homebased cardiac rehabilitation program|homebased cardiac rehabilitation program with monitoring vest Nuubo
16012124|NCT02796404|Other|Traditional cardiac rehabilitation program|multidisciplinary intervention in cardiac rehabilitation gym
16012125|NCT02796391|Drug|Very Low Nicotine Content (VLNC) Cigarettes|"Eligible participants will receive a 1-week supply (based on typical # cigarettes/day x 1.5) of normal nicotine content (NNC) (.8 mg nicotine yield) study cigarettes to smoke exclusively during one baseline week.
~Study 1: Participants (n=20) will then be randomly selected to receive either the lowest nicotine dose of VLNC cigarettes, or gradual decreasing nicotine VLNC cigarettes, ten participants per each group, over the next four weeks.
~Study 2: Participants (n=208) will be randomly assigned to 1 of 4 Study 2 Reduction Arms, 52 participants per arm."
16012126|NCT02796391|Behavioral|One on One Counseling|All participants will receive One on One Counseling.
16012127|NCT02796378|Drug|Training+Simvastatin+Q10-placebo|8 weeks of exercise training on a bycycle ergometer 3 times/week combined with Simvastatin 40 mg/day and Q10-placebo.
16012128|NCT02796378|Drug|Training+Simvastatin-placebo+Q10-placebo|8 weeks of exercise training on a bycycle ergometer 3 times/week combined with Simvastatin-placebo and Q10-placebo.
16012129|NCT02796378|Drug|Training+Simvastatin+Q10|8 weeks of exercise training on a bycycle ergometer 3 times/week combined with Simvastatin 40 mg/day and Q10 400 mg/day.
16012130|NCT02796365|Other|Exercise|Intervention will include 10 weeks of a standard cardiac rehabilitation program consisting of thrice a week aerobic exercise and 1-2 days per week resistance exercises.
16012131|NCT02796352|Drug|High dose bolus interleukin-2 (HD IL2)|"Each course consists of 2 cycles of HD IL2 as follows: high-dose IL2 at 600,000 IU/kg is given intravenously (IV) every 8 hours for up to 14 doses (one cycle), followed by a rest period of 1-2 weeks and readmission for a second HD IL2 cycle for up to 14 doses (second cycle).
~The planned treatment consists of 3 courses (6 cycles) of HD IL-2."
16012132|NCT02796339|Dietary Supplement|Mastiha|
16012133|NCT02796339|Dietary Supplement|Placebo|
16012134|NCT02796326|Device|improved tracheal balloon dilatation|Treatment for laryngotracheal stenosis using a modified tracheal dilatation balloon
16012135|NCT02796313|Behavioral|DASH Groceries + Weekly Sessions|Intervention group participants will receive 1 hour of in-person nutritional counseling and a personalized prescription for the low-salt DASH diet based on estimated calorie needs at baseline, followed by weekly 20-minute phone calls in weeks 1-8 to provide extra support.
16012136|NCT02796313|Behavioral|Groceries + Brochure|Control group participants will receive a printed brochure about the health benefits of a low-salt diet. They will place an unrestricted $35 grocery order for 8 weeks.
16012137|NCT02796300|Device|Bioflo Dialysis Catheter|The catheter placement procedure will be performed in the interventional radiology suite. The catheter will be inserted subcutaneously through incision in the chest through the tract.
16012138|NCT02796300|Device|Palindrome Dialysis Catheter|The catheter placement procedure will be performed in the interventional radiology suite. The catheter will be inserted subcutaneously through incision in the chest through the tract.
16012139|NCT02796287|Procedure|achieving a neuropsychological examination in the acute amnesic phase|achieving a neuropsychological examination in the acute phase in addition to the normal protocole
16012140|NCT02796287|Procedure|Neurological consultation with neuropsychological evaluation|Neurological consultation with neuropsychological evaluation one year after the acute amnesic phase
16012141|NCT02796287|Radiation|MRI|Brain MRI with the same protocol or an acquisition time of 15 minutes without gadolinium, one year after the acute amesic phase
16012142|NCT02796261|Drug|Eflornithine|Eflornithine 2.8 g/m2 administered orally every 8 hours on a 2 week on, 1 week off schedule
16012143|NCT02796261|Drug|Lomustine|Lomustine 90 mg/m2 administered orally once every 6 weeks
16012144|NCT02796261|Drug|Lomustine|Lomustine 110 mg/m2 administered orally once every 6 weeks
16012145|NCT02796248|Other|cross-sectional survey|This is an observation study. Participants will complete a survey at one occasion. Participants are also invited to do a A1c mail-in capillary test.
16012146|NCT02796235|Other|Venous Doppler ultrasound of the lower limbs|Venous Doppler ultrasound of the lower limbs at 6, 9 and 12 months of the initial injury
16012147|NCT02796209|Drug|Atomexetine|Upon completion of the 4-week treatment period (period 1), the investigator or research nurse will instruct the subject to discontinue the study medication for 1 week (wash-out period). After this period, the subject will complete the second 4-week treatment period (period 2).
16012148|NCT02796209|Drug|Placebo|Upon completion of the 4-week treatment period (period 1), the investigator or research nurse will instruct the subject to discontinue the study medication for 1 week (wash-out period). After this period, the subject will complete the second 4-week treatment period (period 2).
16012149|NCT02796196|Other|Medical Chart Review|Review of medical chart
16012150|NCT02796196|Device|Monitoring Device|Wearable physical activity monitoring device
16012151|NCT02796196|Procedure|Physical Therapy|Undergo primarily self-directed physical therapy
16012152|NCT02796183|Drug|Subconjunctival bevacizumab (Altuzan)|Subconjunctival injections of Altuzan 3.75mg were applied in order to eliminate the macular edema.
16012153|NCT02796170|Drug|Dapagliflozin|5mg pill taken once daily
16012154|NCT02796170|Drug|Sulfonylurea|Subjects may take any of the sulfonlyurea medications, titration will be done per standard of care.
16012155|NCT02796170|Drug|Placebo|5mg pill taken once daily- placebo of Dapagliflozin
16012156|NCT02796157|Device|PCI with Absorb everolimus-eluting bioresorbable vascular scaffold|Patients allocated to this arm will undergone PCI with Absorb everolimus-eluting bioresorbable vascular scaffold. It will be allowed to used multiple stents for a long coronary lesion.
16012159|NCT02796144|Drug|Metformin|Max dose of 1,000 mg BID
16012160|NCT02796144|Drug|Placebo|Matching placebos will be administered for each drug.
16012161|NCT02796131|Drug|RDX5791|
16012162|NCT02796131|Drug|Placebo|Placebo
16012163|NCT02796118|Drug|ASP2151|Oral
16012164|NCT02796118|Drug|Placebo|Oral
16012165|NCT02796105|Drug|Progevera|
16012166|NCT02796105|Drug|Orgalutran|
16012167|NCT02796092|Device|Fibered platinum coils|
16012168|NCT02796092|Device|Vascular plugs|
16012169|NCT02796079|Biological|mesenchymal stem cells|stem cell acquisition, processing and reinfection, to evaluate the efficacy by using autologous bone marrow stem cell
16012170|NCT02796079|Biological|saline|saline injections
16012171|NCT02796066|Drug|Vehicle|Applied once a day
16012172|NCT02796066|Drug|TSN2898|Applied once a day
16012173|NCT02796066|Drug|TSN2898|Applied once a day
16012174|NCT02796066|Drug|TSN2898|Applied once a day
16012175|NCT02796053|Drug|TAB08|The TAB08 will be administered intravenously, by infusion.
16012176|NCT02796053|Other|Placebo|The Placebo to TAB08 will be administered intravenously, by infusion.
16012177|NCT02796040|Device|MRI|
16012178|NCT02796027|Other|BRIDGE|"BRIDGE, enhanced HIV service integration package, has three components:
~peer driven recruitment using a Social Network Strategy (SNS) -- which has been designated as a high impact and highly effective strategy by the CDC for reaching out and engaging PWID in HIV testing
~HCT using CTR with Rapid Testing
~ARTAS -- a CDC case management strategy for linking HIV-positive PWID to HIV care that addresses specific barriers and gaps in HIV service delivery in NSPs"
16012179|NCT02796001|Biological|human rhinovirus|human rhinovirus
16012180|NCT02795988|Biological|IMU-131|IMU-131 vaccine is a P467-CRM197 peptide antigen in PBS buffer and Montanide ISA 51 Sterile adjuvant
16012181|NCT02795988|Drug|Cisplatin and either Fluorouracil (5-FU) or Capecitabine or Oxaliplatin and capecitabine.|Chemotherapy will consist of: cisplatin by intravenous administration at 80 mg/m2 on the first day of each cycle and either 5-FU, 4000 mg/m2 CIV (administered as 1000 mg/m2/day as continuous infusion for 96 hours on days 1 to 4 of each cycle) or capecitabine for 14 days at 2000 mg/m2/day, orally (administered as 1000 mg/m2 twice daily morning and evening for a total of 2000 mg/m2/day on days 1 to 14 of each cycle), or (in Phase 2 only) oxaliplatin, by intravenous administration at 130 mg/m2 on Day 1 of each cycle and capecitabine for 14 days at 2000 mg/m2/day, orally (administered as 1000 mg/m2 twice daily morning and evening for a total of 2000 mg/m2/day on days 1 to 14 of each cycle).
16012182|NCT02795962|Other|Direct transfer to an Endovascular Center|Cluster randomized controlled study: allocation to active or no intervention arm will be performed accordingly to a pre-established temporal sequence
16012183|NCT02795949|Drug|Antipseudomonal beta-lactam antibiotic|Pharmaceutical form: solution for infusion
16012184|NCT02795949|Drug|De-escalation(short-spectrum antibiotic)|Pharmaceutical form: solution for infusion
16012185|NCT02795936|Procedure|Cardiac rehabilitation|Perform exercise prescription for 12 weeks
16012186|NCT02795910|Behavioral|Outreach education training|Printed copies of the patient management tool (PMT) and outreach education training
16012187|NCT02795910|Behavioral|No outreach education training|Printed copies of the patient management tool (PMT) without outreach education training
16012188|NCT02795884|Drug|intercalation therapy using pemetrexed, cisplatin and erlotinib|During the intercalation phase of the initial 12-week period, erlotinib is to be orally administered at the dose of 150 mg daily from Day 8 to Day 21 at every cycle of 21 days. During the maintenance phase after 12 weeks, it is orally administered at the cycle of 28 days without a wash-out period at the dose of 150 mg daily for one year. The combination of pemetrexed and cisplatin will be administered for 4 cycles in total by each cycle of 21 days, and it is to be administered by intravenous (IV) infusion on every Day 1. Pemetrexed 500 mg/m2 will be diluted in 100 ml of 0.9% saline solution and will be administered by intravenous (IV) infusion for 10 minutes. Cisplatin 75 mg/m2 will be diluted in 150 ml of 0.9% saline solution and will be administered by intravenous (IV) infusion for 10 to 15 minutes. The combination of pemetrexed and cisplatin will be administered for 4 cycles in total by each cycle of 21 days, and it is to be administered by intravenous (IV) infusion on every Day 1.
16012189|NCT02795884|Drug|Vinorelbine, cisplatin|Vinorelbine 25mg/m2 will be diluted in 50 ml of 0.9% saline solution and will be administered by intravenous (IV) infusion for 6 to 10 minutes and then wash the catheter using 100 ml of 0.9% saline solution. Cisplatin 75 mg/m2 will be diluted in 150 ml of 0.9% saline solution and will be administered by intravenous (IV) infusion for 10 to 15 minutes.
16012190|NCT02795871|Behavioral|Neuropsychological and cognitive assessment|
16012191|NCT02795858|Drug|Ramucirumab|
16012192|NCT02795858|Drug|Somatostatin Analog|
16012193|NCT02795845|Dietary Supplement|Probiotic Capsule containing L. acidophilus, L. Paracasei, L. Rhamnosus, streptococcus thermophilus and Bifidobacterium bifidum|Probiotic
16012194|NCT02795845|Other|Placebo|capsule without active ingredient
16012195|NCT02795832|Drug|ZPL-5212372 1% w/w Ointment BID|
16012196|NCT02795832|Drug|Placebo Ointment BID|
16012197|NCT02795819|Drug|AR-42|AR-42 tablets were taken orally once per day on 3 non-consecutive days during the first 3 weeks of each 4-week cycle. If treatment was interrupted during the cycle, the cycle was to be extended
16012198|NCT02795819|Drug|Pazopanib|Pazopanib tablets were taken orally once daily continuously during each 4-week treatment cycle. There were no scheduled breaks in pazopanib therapy
16012199|NCT02795793|Drug|Non-operative management group (NOM)|With intravenous Piperacillin with Tazobactam (Tazocin)
16012200|NCT02795793|Procedure|Appendectomy group (Operative management, OM)|
16012201|NCT02795780|Drug|Flortaucipir F18|370 megabecquerel (MBq) IV single-dose
16012202|NCT02795780|Procedure|PET Scan|positron emission tomography (PET) scan
16012203|NCT02795767|Drug|Emicizumab|Emicizumab will be administered as per the schedule specified in the respective arm.
16012204|NCT02795754|Drug|GSK2838232 PIB|GSK2838232 will be available as oral suspension for reconstitution, will be administered as 50, 100 and 200 mg in Part A and as 20, 50, 100 or 200 mg in Part B.
16012205|NCT02795754|Drug|GSK2838232 IR1|GSK2838232 will be available as film-coated tablet for oral use
16012206|NCT02795754|Drug|GSK2838232 IR2|GSK2838232 will be available as film-coated tablet for oral use
16071172|NCT02374567|Drug|Lithium|
16012207|NCT02795754|Drug|Placebo PIB|Oral suspension of hydromellulose acetate succinate will be supplied as powder-in-bottle for reconstitution.
16012208|NCT02795754|Drug|Ritonavir|It is to be purchased by site. It will be white film-coated ovaloid tablets for oral administration.
16012209|NCT02795741|Device|Cooling Bolero|a vest filled with a new material (not ice or a gel) that provides controlled cooling by absorbing heat
16012210|NCT02795728|Other|Application of the GIC based sealant|Application of the GIC based sealant was carried out according to the manufacturer's instructions.
16012211|NCT02795728|Other|Resin based sealant|Application of the resin based sealant on the occlusal surfaces was carried out as per the manufacturer s recommendations.
16012212|NCT02795715|Device|tDCS|
16012213|NCT02795715|Behavioral|training|
16012214|NCT02795702|Device|tDCS|Transcranial direct current stimulation
16012215|NCT02795702|Behavioral|training|Cognitive training
16012216|NCT02795676|Biological|PRX-102 (pegunigalsidase alfa)|PRX-102 1 mg/kg every 2 weeks
16012217|NCT02795676|Biological|agalsidase beta|agalsidase beta 1 mg/kg every 2 weeks
16012218|NCT02795663|Device|NIRS EEG HR recording|NIRS EEG HR recording
16012219|NCT02795650|Drug|Personalised treatment|Personalised treatments include chemotherapy, targeted therapy, immunotherapy or others based on the previous test results, chosen from a database that include more than 2000 different drugs.
16012220|NCT02795650|Drug|Treatment chosen per investigator´s judge|Investigators are allowed to chose what they consider the best standard treatment option for their patients.
16012221|NCT02795637|Drug|dasotraline|dasotraline 8mg capsule/day
16012222|NCT02795624|Procedure|Spirometry|Test is done to assess how well the lungs work by measuring how much air is inhaled, how much is exhaled, and how quickly it is exhaled.
16012223|NCT02795624|Procedure|Pulse Wave Analysis|It is a non-invasive assessment of the pulse character
16012224|NCT02795624|Procedure|Peripheral arterial tonometry|It is a non-invasive method to measure endothelial dysfunction.
16012225|NCT02795611|Behavioral|Family-centered occupational therapy|Caregivers will be equipped with the skills of guiding children with ASD in play and participation in their daily life.
16012226|NCT02795611|Behavioral|regular occupational therapy|regular occupational therapy
16012227|NCT02795611|Other|intervention done outside our hospital|intervention done outside our hospital
16012228|NCT02795598|Procedure|Single injection supraclavicular nerve block|"The ultrasound probe will be applied in a sterile fashion in the supraclavicular fossa to obtain a short-axis view of the subclavian artery. A 22G, 50mm Echogenic Stimuplex needle will be advanced in-plane with respect to the image, and the needle tip will be advanced to the junction of the first rib and subclavian artery. Ultrasound cineloops will be kept of all nerve block procedures.
~30 milliliters of mepivacaine 1.5% will be injected incrementally in 5ml boluses at this location looking for spread of local anesthetic under and medial to the subclavian artery. The needle may be slightly repositioned to improve the distribution of the injectate at the discretion of the attending anesthesiologist."
16012229|NCT02795598|Procedure|Double injection supraclavicular nerve block|"The ultrasound probe will be applied in a sterile fashion in the supraclavicular fossa to obtain a short-axis view of the subclavian artery. A 22G, 50mm Echogenic Stimuplex needle will be advanced in-plane with respect to the image, and the needle tip will be advanced to the junction of the first rib and subclavian artery. Ultrasound cineloops will be kept of all nerve block procedures.
~15 milliliters of mepivacaine 1.5% will be injected incrementally at the same, above-mentioned location. The needle will then be redirected to the superolateral aspect of the brachial plexus, and an additional 15ml will be injected here. Again, the needle may slightly repositioned at the discretion of the attending anesthesiologist in order to obtain adequate spread."
16012230|NCT02795585|Other|QFR (observational)|QFR assessment by Medis Suite, Medis medical imaging B.V., The Netherlands
16012231|NCT02795572|Dietary Supplement|Vitamin D|Vitamin D 2000 IU oral once daily
16012232|NCT02795572|Dietary Supplement|Vitamin B6|Vitamin B6 100 mg oral once daily
16012233|NCT02795572|Dietary Supplement|Vitamin B12|Vitamin B12 100 mcg oral once daily
16012234|NCT02795572|Dietary Supplement|Omega-3 Fatty Acids|Omega-3 Fatty Acids 900 mg oral three times a day (600 mg EPA, 300 mg DHA)
16012235|NCT02795559|Other|Glucose|75g glucose dissolved in 300ml water
16012236|NCT02795559|Other|Inulin|75g glucose plus 24g inulin dissolved in 300ml water
16012237|NCT02795559|Other|Resistant starch|75g glucose plus 28g resistant starch in 300ml water
16012238|NCT02795546|Drug|Alendronate sodium|400µg of alendronate sodium is combined with beta-tricalcium phosphate bone graft and implanted in periodontal intra-osseous defects as a single, local dose.
16012239|NCT02795546|Biological|beta-tricalcium phosphate bone substitute|beta-tricalcium phosphate bone graft is implanted in periodontal intra-osseous defects.
16012240|NCT02795533|Behavioral|Clinical follow-up|"All included patients will have a clinical follow-up consisting of:
~A medical examination
~Quality of life questionnaires
~Neuropsychological test
~All instruments have been translated into Norwegian and validated and tested in clinical practice."
16012241|NCT02795520|Drug|OTS167IV|
16012242|NCT02795507|Device|Rehabit-Tec System|Device with visual and kinesthetic feedback
16012243|NCT02795507|Device|Rehabit-Tec System|Device without visual and kinesthetic feedback
16012244|NCT02795507|Behavioral|conventional exercises|
16012245|NCT02795494|Behavioral|WOMAC questionnaire at baseline|Patient-reported pain, stiffness and physical function outcome score
16012246|NCT02795494|Behavioral|ASK-P questionnaire at baseline|Patient-reported activity level score
16012247|NCT02795494|Behavioral|WOMAC questionnaire at 2 weeks|Patient-reported pain, stiffness and physical function outcome score
16012248|NCT02795468|Procedure|Radial arterial cannulation|Radial arterial cannulation using usual palpation method or ultrasound guided technique according to the group
16012301|NCT02795078|Procedure|Interventional embolization forAneurysms|
16012302|NCT02795078|Procedure|stenting for stenosis|
16012303|NCT02795065|Drug|Enoxaparin|Use of enoxaparin 40 mg subcutaneous once daily in high risk intensive care patients as a prophylaxis against venous thromboembolism
16012304|NCT02795065|Drug|Bemiparin|Use of bemiparin 3500 IU subcutaneous once daily in high risk intensive care patients as a prophylaxis against venous thromboembolism
16072006|NCT02368327|Biological|Fendrix|
16012249|NCT02795455|Behavioral|Interoceptive Exposure (IE)|Participants are provided with a meal replacement shake of 'unknown' Kcal or macronutrient content and are asked to mindfully observe the sensations (aversive taste, texture, bloating, icky feeling, etc.) and associated emotional states (i.e., disgust) with the empathetic support of parents/therapist in session, without expectation of habituation. Sessions occur on a weekly basis with session one lasting 2 hrs. The remaining 5 sessions last one hour, and participants eat a meal replacement shake over 30-minutes, identical to the first session. All sessions include debriefing and development of IE homework that includes daily practice of IE.
16012250|NCT02795455|Behavioral|Family Based Therapy-Weight Gain Control (FBT-WG)|Participants and families randomized to FBT-WG will receive 6-weeks of FBT treatment for AN. Sessions occur weekly, with the first session lasting two hours and the remaining 5 sessions one hour. FBT is atheoretical in terms of the etiology, but uses parent-enforced contingencies to increase value of eating and decrease the value of food avoidance.
16012251|NCT02795455|Dietary Supplement|meal replacement shake|
16012252|NCT02795442|Other|Even protein|5 day intake of even protein 3 day rotating menu.
16012253|NCT02795442|Other|Skewed protein|5 day intake of skewed protein 3 day rotating menu.
16012254|NCT02795429|Drug|PDR001|PDR001 will be administered intravenously
16012255|NCT02795429|Drug|INC280|INC280 will be administered orally
16012256|NCT02795416|Drug|"Secukinumab Cosentyx TM"|"Secukinumab Cosentyx TM 150 mg PFS (pre-filled syringe) containing for solution for s.c. injection will be applied as 2 units (300 mg dosage) per patient at each visit.
~First month: 300 mg injections/week, 4 weeks Starting from 4th week until Week 16, one injection/month"
16012257|NCT02795403|Other|blood draw of 150ml, twice|
16012258|NCT02795390|Drug|Chinese herbal medicine|
16012259|NCT02795390|Drug|Placebo|
16012260|NCT02795364|Procedure|Structural Image Guidance|Resecting the tumor in accordance with the margin on MRI T1W-enhanced delineation
16012261|NCT02795364|Procedure|Metabolic Image Guidance|Aggressive resecting of the tumor in accordance with the margin on MRS CNI delineation
16012262|NCT02795351|Drug|Sildenafil|Single oral administration of active or placebo one week apart
16012263|NCT02795351|Drug|Placebo|
16012264|NCT02795338|Procedure|brain mapping|pre-operative and intra-operative brain mapping to identify eloquent areas
16012265|NCT02795325|Drug|DCR-PH1|IV infusion of DCR-PH1
16012266|NCT02795325|Other|Placebo|
16012267|NCT02795312|Behavioral|Smoking Cessation Program|Participants will take part in a 9-week Smoking Cessation Program
16012268|NCT02795299|Drug|Gerilimzumab|Either Gerilimzumab 5 mg followed by 2 mg, or Gerilimzumab 10 mg followed by 5 mg or Gerilimzumab 20 mg followed by 10 mg are to be administered once every 8 weeks during the treatment period of the study.
16012269|NCT02795299|Drug|Methotrexate|Methotrexate (MTX) to be administered once a week every week during the treatment period.
16012270|NCT02795299|Drug|Folic Acid|Acid folic (folate) 1mg to be administered once daily during the treatment period.
16012271|NCT02795299|Drug|Placebo|10 mM acetate, 9% (w/v) sucrose, and 0.006% (w/v) polysorbate 20 at pH 5.2 ± 0.3
16012272|NCT02795286|Device|Artis Haemodialysis Machine w/ ASIST Software - Isonatremic|
16012273|NCT02795286|Device|Artis Haemodialysis Machine w/ ASIST Software - Isotonic|
16012274|NCT02795286|Device|Artis Haemodialysis Machine w/o ASIST Software|
16012275|NCT02795273|Drug|Grass-SPIRE|
16012276|NCT02795273|Drug|Placebo|
16012277|NCT02795260|Biological|Bacillus Calmette - Guerin|The participants are injection intradermally with 0.1ml ESAT6-CFP10(EC) in the right OR left arm and TB-PPD in the other arm(right OR left) after 12 weeks immunization of BCG .
16012278|NCT02795260|Biological|placebo of Bacillus Calmette - Guerin|The participants are injection intradermally with 0.1ml ESAT6-CFP10(EC) in the right OR left arm and TB-PPD in the other arm(right OR left) after 12 weeks immunization of placebo of BCG .
16012279|NCT02795247|Procedure|Anterior Cruciate Ligament Reconstruction|
16012280|NCT02795234|Other|Blood samples|
16012281|NCT02795208|Procedure|Lung recruitment maneuver|The lung recruitment maneuver consists in a brief and controlled increment in airways pressure (20 cmH2O of PEEP + 20 cmH2O of driving pressure) for 10 breaths.
16012282|NCT02795195|Radiation|Carbon ion radiotherapy (CIRT)|Four dose levels (54GyE, 57GyE, 60GyE, 63GyE) are planned within the Phase I part. Daily fraction of 3 GyE will be delivered for all dose levels. After the recommended dose (RD), i.e., maximal tolerated dose, is determined or if the treatments to 63 GyE are safely delivered, the recommended dose (or 63 GyE) will be the prescribed dose in the Phase II part of the study. Ninety-five percent (95%) of the isodose line should cover the gross tumor volume plus 3~5mm.
16012283|NCT02795182|Drug|BGB-3111|
16012284|NCT02795182|Drug|BGB-A317|
16012285|NCT02795156|Drug|afatinib|40 mg orally (p.o.) once daily for each 28-day cycle
16012286|NCT02795156|Drug|regorafenib|160 mg p.o. once daily for the first 21-days of each 28-day
16012287|NCT02795156|Drug|Cabozantinib|60 mg p.o. once daily for each 28-day cycle
16012288|NCT02795143|Drug|Isotretinoin|
16012289|NCT02795143|Other|Placebo|
16012290|NCT02795130|Procedure|Sclerotomy closure|Comparison between two suture materials: 1) 8-0 polyglactin 910, 2) 6-0 plain gut
16012291|NCT02795117|Drug|Ivermectin|
16012292|NCT02795117|Drug|Ivermectin (reference)|
16012293|NCT02795117|Drug|Placebo|
16012294|NCT02795104|Behavioral|Educational Intervention via brochure|"Educational Intervention via brochure:
~In this arm of the educational intervention the participant receives brochures"
16012295|NCT02795104|Behavioral|Educational Intervention via DVD|Educational Intervention via DVD: In this arm of the educational intervention the participant receive a tailored interactive DVD to watch
16012296|NCT02795104|Behavioral|Educational Intervention-DVD & Telephone Based Navigation|Educational Intervention via Telephone-Based Navigation: In this arm of the educational intervention the participant receives a tailored interactive DVD to watch and telephone calls from a patient navigator
16012297|NCT02795091|Other|manual cleaning|manual clean the rag and floor towel
16012298|NCT02795091|Device|machine clean|machine clean the rag and floor towel
16012299|NCT02795078|Drug|conservative treatment|
16012300|NCT02795078|Procedure|Aneurysms clipping|
16012412|NCT02794298|Device|sham-tDCS|
16012305|NCT02795052|Procedure|Intravenous BMSC|Autologous Bone Marrow Derived Stem Cells provided intravenous.
16012306|NCT02795052|Procedure|Intranasal BMSC|Autologous Bone Marrow Derived Stem Cells provided intranasal (lower 1/3 of nasal passages).
16012307|NCT02795039|Drug|Fulvestrant|Single 5 mL intramuscular injection (slowly over 1-2 minutes) of Fulvestrant into the right buttock (upper outer quadrant)
16012308|NCT02795039|Drug|Fulvestrant|Single 5 mL intramuscular injection (slowly over 1-2 minutes) of Faslodex® (Fulvestrant) into the right buttock (upper outer quadrant)
16012309|NCT02795026|Procedure|Manual therapy|Myofascial trigger point release technique is a technique used to help ease tight muscles. This technique involves palpating the tight muscle for the 'knot'/trigger point and gently applying pressure for 30-60 seconds to help ease out the trigger point.
16012310|NCT02795026|Procedure|Trigger point dry needling|Trigger point dry needling is a treatment technique involving the use of a single, disposable, fine filament acupuncture needle. Here the tight muscle is palpated and the acupuncture needle is directed towards the trigger point. The insertion of the needle is not felt, however the twitch reflex elicited to ease off the trigger point can be felt . This can be sore, but lasts only for a few seconds. Trans-perineal trigger point dry needling is an effective dry needling technique for the pelvic floor muscles done externally, targeting the trigger points in the pelvic floor muscles.
16012311|NCT02794987|Device|SpyGlass® choledoscopy|Stage 1: patients included were evaluated using a standard duodenoscope and both SpyGlass® cholangioscopes: First generation, SpyGlass® Direct Visualization System and Second generation, Digital SpyGlass® DS System (Boston Scientific, Marlborough, Massachusetts, USA) Procedures were performed by one experienced endoscopists with more than 300 ERCP/year (C.R.M). Biopsies were taken in order to correlate to histopathology. Stage 2: patients will be evaluated using a standard duodenoscope and second generation, Digital SpyGlass® DS System (Boston Scientific, Marlborough, Massachusetts, USA). Procedures will be performed by two experienced endoscopists with more than 300 ERCP/year (C.R.M and M.S.A). Biopsies will be taken in order to correlate to histopathology.
16012312|NCT02794974|Other|cervical plexus block|ultrasound-guided application of 20ml ropivacaine 0.75%
16012313|NCT02794974|Other|facial nerve block|ultrasound-guided application of 5ml prilocaine 1%
16012314|NCT02794974|Other|perivascular block|ultrasound-guided application of 5ml prilocaine 1%
16012315|NCT02794961|Biological|CD22 CAR-T|Autologous CAR-T cells with average 1*10^6 cells/kg body weight
16012316|NCT02794948|Other|Chinese medicine granules (HuYang Yang Kun Formula)|Take Chinese medicine granules (HuYang Yang Kun Formula), 1 sack every time,twice a day Take DHEA(dehydroepiandrosterone) placebo,1 capsule every time ,once a day. Treatment for 3 months Both Chinese Medicine formula granules and DHEA placebo were produced by Jiangyin Medical &pharmaceutical limited company in Jiangsu province
16012317|NCT02794948|Dietary Supplement|dehydroepiandrosterone|The DHEA( dehydroepiandrosterone)25mg,1 capsule every time once a day. Take Chinese medicine granules placebo , 1 sack every time,twice a day Treatment is 3 months. DHEA were produced by General Nutrition Center(GNC)company in America and The placebo granules of Chinese Medicine were produced by Jiangyin Medical &pharmaceutical limited company in Jiangsu province.
16012318|NCT02794935|Other|Inspiratory muscle training (IMT)|Participants will be submitted to a linear pressure resistance (PowerBreathe) with an inspiratory load of 30% of maximal inspiratory pressure (adjusted weekly), seven days a week, session duration of 30 minutes for 12 weeks. During training, participants will be instructed to maintain diaphragmatic breathing with a breathing rate of 15-20 cycles/min. Inspiratory load will be set at 30% of maximum static inspiratory pressure, and weekly training loads will be adjusted to maintain 30% of MIP. Each week, six training sessions will be held at home and a training session will be supervised in the research center.
16012319|NCT02794935|Other|Sham IMT|Participants will be submitted to inspiratory muscle training with the same equipment as the intervention group, but without a load generating resistance. Sham IMT Participants will receive IMT for 30 min, 7 times per week for 12 weeks using Inspiratory muscle trainer device (PowerBreathe). During training, participants will be instructed to maintain diaphragmatic breathing with a breathing rate of 15-20 cycles/min, but without a load generating resistance. Each week, six training sessions will be held at home and a training session will be supervised in the research center
16012320|NCT02794922|Drug|Neurovit Forte|
16012321|NCT02794922|Drug|Corn Starch|
16012322|NCT02794909|Device|Cardiopulmonary ultrasound exam|The cardiopulmonary ultrasound exam consists of a point-of-care ultrasound scan of the heart, lungs, peritoneal cavity, aorta, and femoral veins.
16012323|NCT02794896|Drug|High dose propofol, fentanyl and sevoflurane|Deep Anesthesia
16012324|NCT02794896|Drug|Low dose propofol, fentanyl and sevoflurane|Shallow Anesthesia
16012325|NCT02794883|Biological|Durvalumab|Given IV
16012326|NCT02794883|Other|Laboratory Biomarker Analysis|Correlative Studies
16012327|NCT02794883|Procedure|Surgical Procedure|Undergo surgical tumor resection
16012328|NCT02794883|Biological|Tremelimumab|Given IV
16012329|NCT02794870|Biological|RSV LID ΔM2-2 1030s vaccine|10^5.0 PFU; administered as nose drops
16012330|NCT02794870|Biological|Placebo|Isotonic diluent, administered as nose drops
16012331|NCT02794857|Drug|NP001|
16012332|NCT02794857|Drug|Placebo|
16012333|NCT02794844|Drug|Genotype Guided PPI Dosing|Dosing of PPIs such as Prevacid and Nexium will be recommended based on CYP2C19 genotype information.
16012334|NCT02794818|Behavioral|Produce boxes with nutritional education|"CSA produce boxes prescribed to study participants with free online nutritional education included"
16012335|NCT02794805|Device|¹³C-Octanoate Breath Test|Octanoate Breath Test to be performed on subjects with suspected HCC
16012336|NCT02794792|Drug|Ipragliflozin L-proline|Oral
16012337|NCT02794792|Drug|Metformin|Oral
16012338|NCT02794792|Drug|Placebo|Oral
16012339|NCT02794779|Drug|Oxytocin|Intravenous bolus infusion of oxytocin 3UI followed by re-asessment of uterine tone by obstetrician after 3 minutes. Infusion stops when uterine tone is adequate and is repeated if inadequate to the maximum of 9UI (3 bolus infusions). If uretine tone is inadequate after 9UI then other methods for preventing bleeding will be used.
16012340|NCT02794766|Drug|Inulin+SS|Experimental treatment: A gum of inulin 1g plus Streptococcus salivarius 1 billion CFU per oral each 12 hours for 10 days
16012341|NCT02794766|Drug|S salivarius|Active comparator: A gum of Streptococcus salivarius 1 billion CFU per oral each 12 hours for 10 days
16012342|NCT02794766|Drug|Placebo|Placebo 1 gum each 12 hours for 10 days
16012343|NCT02794753|Behavioral|Working memory training|
16012344|NCT02794753|Behavioral|Game|
16012345|NCT02794740|Drug|X0002|External Spray
16012346|NCT02794740|Drug|Placebo|External Spray
16012347|NCT02794727|Device|Blinded Fitbit|Subjects will wear a blinded Fitbit to monitor activity while in the workplace for 12 weeks.
16012348|NCT02794727|Device|Unblinded Fitbit|Subjects will be unblinded to the Fitbit display for 12 weeks with set activity goals.
16012349|NCT02794714|Drug|Deep neuromuscular blockade|Deep neuromuscular blockade attained during surgery using Rocuronium 0.6mg/kg at induction of anesthesia with intermittent boluses of 0.15 - 0.2 mg/kg to maintain a Post Tetanic Count (PTC) of 1-2 throughout surgery. Neuromuscular blockade reversed at the end of surgery with Sugammadex 4mg/kg.
16012350|NCT02794714|Drug|Moderate neuromuscular blockade|Moderate neuromuscular blockade attained during surgery using Rocuronium 0.6mg/kg at induction with intermittent boluses of 0.15 - 0.2 mg/kg to maintain Train of Four Count (TOFC) of 2 throughout surgery. Neuromuscular blockade reversed at the end of surgery with Sugammadex 2mg/kg.
16012351|NCT02794701|Other|People with silicosis|
16012352|NCT02794688|Procedure|Ductal lavage therapy|"Patient lies in supine position, with routine sterilizing and draping procedure.
~Local anesthesia with 2ml lidocaine (1%) around the nipple.
~Identification of 4-5 openings of the lactiferous ducts from the nipple.
~Insertion of all infusion cannula (21-23G ) into the identified openings of the lactiferous ducts.
~Start the infusion pump with 15ml irrigation solution (2% Lidocaine 5ml, Triamcinolone acetonide 40mg，0.9% saline 10ml and ceftriaxone 1.0g). If the patients had elevated white blood cell count and fever (>38 celsius degree), oral intake or infusion of antibiotics were allowed, when necessary.
~The patient returns to the clinic the next day, with the irrigation solution staying in the lactiferous ducts overnight, and receives breast massage.
~Repeat step 1-6 every other day for 2 weeks.
~Fine needle aspiration is allowed. Oral intake of corticosteroids, excisional drainage or surgery are not allowed."
16012353|NCT02794675|Drug|Cesium 131|The number sources and activity will be based on the target volume to deliver total radiation dose, this will vary per patient.
16012354|NCT02794662|Procedure|Oxygen Environment|FiO2 delivered by servo-controlled incubator
16012355|NCT02794662|Procedure|Nasal Cannula Oxygen|FiO2 delivered by nasal cannula
16012356|NCT02794623|Device|Tinnitus masking|Tinnitus masking via CI system
16012357|NCT02794610|Drug|Tacrolimus|Topical tacrolimus 0.05% eye drops will be instilled into the eyes of patients every minute for 5 minutes. After 15 minutes, at the time of cataract surgery, aqueous samples will be collected and will be subjected to detection of presence and level of tacrolimus.
16012358|NCT02794597|Behavioral|SHINE intervention group|Includes all substance treatment services as well as the brief peer-led behavioral intervention focused on contraceptives, reproductive needs, and motivational interviewing: Sexual Health Initiative for Navigation and Empowerment (SHINE).
16012359|NCT02794584|Drug|sufentanil anesthesia|Anaesthesia is maintained by inhaled isoflurane in concentrations 0.7-0.8 % end-tidal with additional sufentanil injected during surgery, as required. During extracorporal circulation patients receive isoflurane via a vaporizer incorporated in the extracorporeal gas supply in the same concentrations.
16012360|NCT02794584|Procedure|Hybrid closure|Hybrid closure of ventricular septal defects through the delivery system without cardiopulmonary bypass by transthoracic minimally invasive small incision.
16012361|NCT02794584|Procedure|Control|Surgical closure of ventricular septal defects with cardiopulmonary bypass by routine open thoracotomy.
16012362|NCT02794571|Drug|Atezolizumab|Atezolizumab will be given as 1200 mg via IV infusion on Day 1 of each 21-day cycle or as 1680 mg via IV infusion on Day 1 of each 28-day cycle.
16012363|NCT02794571|Drug|Tiragolumab|Several dose levels will be evaluated for tiragolumab administered as a single agent and in combination with atezolizumab and/or other anti-cancer therapies. Tiragolumab will be given via IV infusion on Day 1 of each cycle (21-day or 28-day depending on study cohort and phase) until disease progression or loss of clinical benefit. Those who discontinue treatment with single-agent tiragolumab may receive combination treatment with tiragolumab and atezolizumab and/or other anti-cancer therapies. Combination treatment may continue until disease progression or loss of clinical benefit.
16012364|NCT02794571|Drug|Carboplatin|Carboplatin, AUC of 6 milligram per milliliter per minute (mg/ml/min) for Cohorts A and B and AUC of 5 mg/ml/min for Cohort C, IV infusion will be administered on Day 1 of each 21-day cycle after combination treatment of atezolizumab and tiragolumab IV infusion.
16012365|NCT02794571|Drug|Cisplatin|Cisplatin 75 milligram per square meter (mg/m^2) IV infusion will be administered on day 1 of each 21-day cycle after combination treatment of atezolizumab and tiragolumab.
16012366|NCT02794571|Drug|Pemetrexed|Pemetrexed 500 mg/m^2 IV infusion will be administered on Day 1 of each 21-day cycle after carboplatin or cisplatin IV infusion with combination treatment of atezolizumab and tiragolumab.
16012367|NCT02794571|Drug|Paclitaxel|Paclitaxel 200 mg/m^2 IV infusion will be administered on Day 1 of each 21-day cycle after combination treatment with atezolizumab and tiragolumab.
16012368|NCT02794571|Drug|Etoposide|Etoposide 100 mg/m^2 IV infusion will be administered on Days 1, 2, and 3 of each 21-day cycle with combination treatment of atezolizumab and tiragolumab.
16012369|NCT02794571|Drug|Capecitabine|Capecitabine 1250 mg/m^2 oral dose will be administered twice daily (BID) on Days 1 through 14 of each 21-day cycle. On Day 1 of Cycle 1, the first dose of capecitabine will be administered prior to the atezolizumab and tiragolumab infusion.
16012370|NCT02794571|Drug|Bevacizumab|Bevacizumab 15 mg/kg IV infusion will be administered on Day 1 of each 21-day cycle after combination treatment of atezolizumab and tiragolumab.
16012371|NCT02794571|Drug|Pembrolizumab|Pembrolizumab 200 mg IV infusion will be administered on Day 1 of each 21-day cycle after treatment with tiragolumab.
16012372|NCT02794558|Device|ExAblate MRgFUS|"MR images of the breast will be obtained for lesion localization purposes. The breast surgeon or the radiologist will make a treatment plan or map. Sonication at therapeutic power level will be performed on multiple overlapping points successively until sonication of the target volume has been completed.
~Follow-up evaluation will be made within 14 to 21 days after the MRgFUS treatment."
16012373|NCT02794545|Procedure|cART course|The investigators would start regular cART course immediately for early infection patients to achieve functional cure.
16012374|NCT02794532|Procedure|High-flow nasal cannula|Oxygenation will be done via a high-flow nasal cannula
16012375|NCT02794519|Drug|Sirukumab|This intervention will be provided in a 1.0 mL pre-filled syringe (PFS) fitted with spring-powered, disposable autoinjector device for single SC use that is permanently assembled on the syringe. The sirukumab PFS is aseptically filled to deliver a dose of 50 mg/1.0 mL of sirukumab.
16012376|NCT02794519|Drug|Placebo|This intervention will be provided in a 1.0 mL pre-filled syringe (PFS) fitted with spring-powered, disposable autoinjector device for single SC use that is permanently assembled on the syringe. The sirukumab PFS is aseptically filled to deliver a dose of 50 mg/1.0 mL of sirukumab.
16012377|NCT02794519|Drug|Rescue medication|Rescue medication (salbutamol/albuterol) shall be supplied to subjects at Screening for use when needed during the study.
16012378|NCT02794506|Drug|Propolis|Propolis capsules was taken by the experimental group for 6 months after receiving scaling and root planing (SRP).
16012379|NCT02794506|Drug|Placebo|Placebo capsules was taken by the control group for 6 months after receiving scaling and root planing (SRP).
16012380|NCT02794493|Drug|Traditional Chinese Medicine Formula LC09|
16012381|NCT02794493|Other|Placebo|
16012382|NCT02794480|Device|ELLIPTA DPI|It is the inhaler with two blister strips containing white coloured powder, one placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate. It is given as oral inhalation (Inhalation powder)
16012383|NCT02794480|Device|GSK MDI|It is the placebo inhaler with clear liquid containing propellant (1,1,1, 2- Tetrafluoroethane). It is given as oral inhalation (Inhalation Aerosol).
16012384|NCT02794480|Device|AZ MDI|It is the placebo inhaler with clear liquid. It is given as oral inhalation (Inhalation Aerosol).
16012385|NCT02794467|Drug|Epelsiban|Epelsiban will be supplied as modified capsule shaped, white coated, oral tablet with a unit dose strength of 25 or 150 mg; to be taken with food or immediately after a meal, without chewing
16012386|NCT02794467|Drug|Placebo|A matching placebo will be supplied as modified capsule shaped, white coated, oral tablet; to be taken with food or immediately after a meal, without chewing.
16012387|NCT02794454|Other|HeezOn Ultra-1|
16012388|NCT02794454|Other|HeezOn Ultra-2|
16012389|NCT02794454|Other|Placebo|
16012390|NCT02794441|Drug|Dexamethasone|Dexamethasone 0.6mg/kg (maximum 15mg) PO x 1 dose
16012391|NCT02794441|Other|Placebo|Matched oral solution
16012392|NCT02794428|Drug|Eflornithine|Eflornithine*, 2 tablets, Oral, Daily for 18 months
16012393|NCT02794428|Other|Eflornithine placebo|Eflornithine placebo, 2 tablets, Oral, Daily for 18 months
16012394|NCT02794415|Other|Community-based exercise|"Intervention Phase (6 months): The HIV Community-Based Exercise (CBE) intervention is a 6-month exercise program at the Central Toronto YMCA. Participants will meet the fitness instructor to establish an individualized exercise program that will include a combination of aerobic, resistive, neuromotor and flexibility training. Participants will attend exercise sessions for ~1.5 hour, 3 times per week for 24 weeks. Sessions will be supervised weekly by a fitness instructor.
~Post-Intervention Phase (8 months): At the end of the 24 week intervention, participants will be encouraged to continue to engage in unsupervised exercise 3 times per week. As per usual practice at the YMCA, a fitness instructor will be available to monitor participants monthly."
16012395|NCT02794402|Drug|Exenatide|Bydureon (Exenatide once weekly) injections s.c.
16012396|NCT02794402|Behavioral|Placebo|Placebo once weekly injections sc
16012397|NCT02794389|Drug|N-acetyl cysteine|
16012398|NCT02794389|Drug|Placebo|
16012399|NCT02794376|Behavioral|Mindfulness Based Cognitive Therapy (MBCT)|
16012400|NCT02794376|Behavioral|Waiting Period|
16012401|NCT02794363|Biological|Autologous platelet rich plasma|5cc of autologous platelet rich plasma derived from 50cc of whole blood will be injected into vulvar skin.
16012402|NCT02794350|Device|Cochlear implant|
16012403|NCT02794337|Radiation|SBRT|Intervention involves administering high precision radiation to the tumour in 6-8 fractions over 2-2.5 weeks
16012404|NCT02794337|Procedure|TACE|Involves catheterization of the tumour feeding vessels and injecting 100 mg of doxorubicin drug eluting beads. Maximum 3 TACE procedures are done
16012405|NCT02794337|Drug|Sorafenib|Sorafenib will be initiated 2 weeks before 1st TACE at a dose considered appropriate by the treating clinician. Though 400 mg bid is the recommended dose a lower dose may be used as per the judgement of treating clinician. It will be omitted on the days of TACE and SBRT. Sorafenib will be reinitiated 4 weeks after SBRT completion and will continue to be administered till progression or 12 months whichever is earlier. Sorafenib can however be stopped in patients who fail to tolerate sorafenib even after dose modifications.
16012406|NCT02794324|Procedure|Voluntary deep-inspiratory breath hold|Patients undergoing scanning in v_DIBH will be positioned supine with arms extended on a MedTec breast board. They will be monitored visually on screen and will be given a buzzer to press when they have taken a breath. CT images will be obtained during DIBH. If the patient needs to release their breath, they will be asked to press the buzzer a second time. Patients will be closely monitored by radiographers via CCTV.
16012407|NCT02794324|Procedure|Active-breathing-controlled deep-inspiratory breathhold|Patients undergoing scanning in ABC_DIBH will be positioned supine with arms extended on a MedTec breast board to which an activated-breathing control device (Elekta, Crawley, UK) has been attached. They will breathe through the device. During ABC_DIBH, CT images will be obtained.
16012408|NCT02794324|Procedure|Prone treatment|Patients undergoing scanning in a prone position will lie on a customised prone treatment platform. CT images will be acquired under free-breathing conditions.
16012409|NCT02794324|Device|Active-breathing-controlled deep-inspiratory breathhold|The ABC unit allows for temporary and reproducible immobilization of internal thoracic structures by monitoring the patient's breathing cycle and implementing a breath hold at a predefined lung volume level. The device consists of a mouthpiece connected to a pneumotachometer via a bidirectional valve and tubing. The air flow across the pneumotachometer is integrated and displayed on a computer monitor. The computer also controls a scissor valve which, when enabled, restricts air flow through the system, enabling the breath hold phase. The mouthpiece and air filter are patient specific, as is a nose clip that is used to ensure that patients are breathing through the device.
16012410|NCT02794311|Other|Alcoolpredict|psychological (personality), neuropsychological (executive functions, memory), genetic (snp polymorphisms) and neuro-anatomical (fMRI)
16012411|NCT02794298|Device|Transcranial direct current stimulation (tDCS)|
16012413|NCT02794285|Biological|Anifrolumab|Anifrolumab IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses
16012414|NCT02794285|Drug|Placebo|Placebo IV administration every 4 weeks from Week 0 to Week 152 for a total of 39 doses
16012415|NCT02794272|Device|tDCS|
16012416|NCT02794272|Device|sham-tDCS|
16012417|NCT02794259|Device|tDCS|
16012418|NCT02794259|Device|sham-tDCS|
16012419|NCT02794246|Biological|CART-19 cells|
16012420|NCT02794233|Other|Impedance measurements|Refer to study description
16012421|NCT02794220|Device|CN electronic cigarette 10 mg|Inhalation
16012422|NCT02794220|Device|CN electronic cigarette 15 mg|Inhalation
16012423|NCT02794220|Device|Nicorette Inhalator 15 mg|Inhalation
16012424|NCT02794220|Other|Cigarette|Inhalation
16012425|NCT02794194|Other|Proprioceptive training on a whole body vibration platform|The Training programme consisted of three series of 4 exercises of 45 seconds with 45 seconds rest between exercises. In this intervention participants trained with the BOSU® on a Fitvibe Excel Pro vibration platform (Fitvibe, Bilzen, Belgium).
16012426|NCT02794194|Other|Proprioceptive training with the BOSU® on the floor|The Training programme consisted of three series of 4 exercises of 45 seconds with 45 seconds rest between exercises. In this intervention participants trained with the BOSU® on the floor.
16012427|NCT02794168|Drug|VAS203|Treatment
16012428|NCT02794168|Drug|Saline|Placebo
16012429|NCT02794155|Drug|HDV Insulin Lispro|HDV Insulin Lispro: ~1% of the Insulin Lispro is bound to HDV (Hepatocyte Directed Vesicle)
16012430|NCT02794155|Drug|Insulin LISPRO|Insulin Lispro: no bound insulin
16012431|NCT02794142|Procedure|renal transplantation|
16012432|NCT02794142|Other|No intervention|
16012433|NCT02794129|Other|Functional Magnetic Resonance Imaging|
16012434|NCT02794116|Procedure|Conventional Sealants|It is a preventive treatment for caries lesions. The procedure following operative sequence: prophylaxis; absolute isolation; application of 37.5% phosphoric acid for 30 s in enamel; extensive washing; drying with cotton and air jet for 5 s; sealing with resin sealant application (Fluroshield, NY, USA), according to manufacturer guidelines; removal absolute isolation; examination of occlusal contact and final polishing.
16012435|NCT02794116|Procedure|Resin Sealants|It is a resin sealants to preventive treatment for caries lesions. The procedure following operative sequence: prophylaxis; absolute isolation; application of 37.5% phosphoric acid for 30 s in enamel; extensive washing; drying with cotton and air jet for 5 s; sealing with resin sealant application (Fluroshield, NY, USA), according to manufacturer guidelines; removal absolute isolation; examination of occlusal contact and final polishing.
16012436|NCT02794103|Device|Virtual Reality Distraction|VR prototype developed by the SAT will be used as the experimental intervention. It has a wide screen installed at the end of the hydrotherapy tank offering a 150-degree field view, on which appears a game allowing the child to have the immersive entertainment experience without the need to wear a helmet or 3D glasses. The child or a proxy, depending on age and burn site, will have the opportunity to interact with the game. The interactive component is not mandatory for the immersive and distractive experiences provided by the prototype. Video games tailored to the child's age and injury, different from the commercially available ones, will be adapted to each age-group of children recruited with control over the speed of movement to avoid motion sickness.
16012437|NCT02794090|Behavioral|Usual care, individual visits|Randomized controlled study of two types of delivering behavioral treatment to Children suffering from obesity.
16012438|NCT02794090|Behavioral|Telephone coaching|Randomized controlled study of two types of delivering behavioral treatment to Children suffering from obesity.
16012439|NCT02794077|Drug|Cyclophosphamide|Patient receive oral cyclophosphamide 50 to 150mg daily continuously in the absence of disease progressive or unacceptable toxicity.
16012440|NCT02794064|Device|Tri-modal imaging|This tri-modal imaging system was developed in collaboration with Sogang University and is composed of three subsystems: ultrasound, photoacoustic and fluorescence. For this study, the fluorescence subsystem will not be used. The photoacoustic and ultrasound subsystems and data acquisition are controlled by a single workstation. The complete system is Canadian Standards Association (CSA) certified
16012441|NCT02794051|Behavioral|Group Therapy|Participating children and their caregivers will attend 90-minute weekly group therapy sessions for 10 consecutive weeks.
16012442|NCT02794038|Device|Soberlink Cellular Device|BAC breath analyzer
16012443|NCT02794038|Device|BACtrack S80 Pro|BAC breath analyzer
16012444|NCT02794025|Drug|Esmolol|"patients in the esmolol group received continuous infusion of esmolol via a micro-pump through a catheter placed in the superior vena cava. The initial dose was 0.05 mg/kg/min and was adjusted based on heart rate (HR) (target HR: 70 bpm < HR < 100 bpm within 72 hours).
~Control group also received natural saline via a micro pump, in the same way the esmolol group received esmolol."
16012445|NCT02794025|Drug|natural saline|Control group also received natural saline via a micro pump,
16012446|NCT02793999|Device|Near-Infrared Spectroscopy (NIRS)|
16012447|NCT02793986|Drug|propofol|For patients in Group P, the sedation was achieved with a target-controlled infusion (TCI) of propofol, and the effect site concentration was set to 0.8-1.0μg/ml.
16012448|NCT02793986|Drug|dexmedetomidine|For patients in Group D, the sedation was achieved with a bolus of dexmedetomidine at 1.0 μg/kg (over a period of 15 to 20 min) and followed by an infusion of dexmedetomidine at 0.2-0.7 μg/kg/h. The depth of sedation was considered enough when patient was unresponsive to voice.
16012449|NCT02793973|Device|shoe lifts|
16012450|NCT02793960|Drug|topical BPM31510 3.0% Cream|Application of drug to lesions of epidermolysis bullosa
16012451|NCT02793947|Drug|Ropivacaine|400 mg of 0.75% ropivacaine (53.33 mL) will be included in the multimodal analgesic cocktail that will be injected intra-operatively into the superficial and deep peri-incisional tissues after completion of femur fracture fixation/instrumentation.
16012452|NCT02793947|Drug|Epinephrine|0.6 mg of 1 mg/mL epinephrine (0.6 mL) will be included in the multimodal analgesic cocktail that will be injected intra-operatively into the superficial and deep peri-incisional tissues after completion of femur fracture fixation/instrumentation.
16012453|NCT02793947|Drug|Morphine|5 mg of 0.5 mg/mL morphine sulfate (10 mL) will be included in the multimodal analgesic cocktail that will be injected intra-operatively into the superficial and deep peri-incisional tissues after completion of femur fracture fixation/instrumentation.
16012454|NCT02793947|Drug|0.9% sodium chloride solution|36.07 mL 0.9% sodium chloride solution will be included in the multimodal analgesic cocktail that will be injected intra-operatively into the superficial and deep peri-incisional tissues after completion of femur fracture fixation/instrumentation.
16012455|NCT02793934|Other|Scales|"For stroke patients there are used scales:
~Modified Rankin Scale, NIH Stroke Scale , Glasgow Coma Scale, Dysphagia Severity, Rating Scale Speech or Language Impairment Severity Rating Scale, Modified Rivermead Mobility Index, Berg Balance Scale, Modified Ashworth Scale, Medical Research Council Scale, Frenchay Arm Test, Montreal Cognitive Assessment Scale, Spielberger Scale, Beck's Depression Inventory, Visual Analogue Scale, Functional Independence Measure For patients after AMI: Rankin scale, GRACE scale, MoCA, VAS, Hospital scale of anxiety and depression, Canadian classification if stenocardia
~For patients after THR:
~The pain of the operated joint on VAS scores The Harris scale (the total amount), Scale Lequesne (total), Hospital scale of anxiety"
16012456|NCT02793934|Other|New model of rehabilitation|
16012457|NCT02793934|Other|Old model of rehabilitation|
16012458|NCT02793934|Other|ICF reader|
16012459|NCT02793921|Behavioral|Moderate-Intensity Aerobic Exercise Intervention|The intervention is moderate-intensity aerobic exercise. Walking on a motorized treadmill will be the encouraged mode of exercise; however participants may use other equipment or home exercise. Participants will begin by exercising 10-15 minutes for 3 days/week during the first 2 weeks and gradually increase the duration for the following 4 weeks until they reach 40-50 minutes per session/3 days per week. This level is then maintained for the remainder of the 6 months. The rate of increase will be tailored based on baseline cardiorespiratory fitness and response to exercise. All sessions start and end with a vital sign check (in-person) and 5-10 minutes warm-up/cool-down. Trained exercise physiologists will supervise all exercise sessions and closely monitor adherence, intensity, and safety when sessions are completed in-person, or through regular communication when home-based exercise is warranted (due to COVID-19).
16012460|NCT02793908|Drug|Pleyris|Luteal phase will be supplemented starting by the ovulation day for 14 days
16012461|NCT02793908|Drug|Crinone8|Luteal phase will be supplemented starting by the ovulation day for 14 days
16012462|NCT02793895|Device|Medtronic SEEQ™ mobile cardiac telemetry system|The SEEQ™ system consists of a wearable sensor which is a single-lead, low-profile, peel-and-stick device applied over the anterior left chest wall of the subject. The wearable patch is designed for one-time use only and cannot be re-applied if removed. Each sensor provides up to 7.5 days of monitoring. Subjects randomized to the intervention group will undergo 30 days of continuous cardiac rhythm monitoring with the SEEQ™ device at the time of randomization. At 6+/-1 months, subjects randomized to the intervention group will undergo 14 days of continuous cardiac rhythm monitoring with the SEEQ™ device.
16012463|NCT02793895|Other|Usual Care|For subjects randomized to the usual care group, no protocol-mandated cardiac rhythm monitoring will be performed. However, subjects in the control group may undergo rhythm monitoring during the study period if their treating physicians deem that there is a clinical indication to so do. At 6+/-1 months, subjects randomized to the usual care group will undergo 14 days of continuous cardiac rhythm monitoring with the SEEQ™ device or the CardioSTAT (Icentia. Inc) cardiac rhythm monitoring device.
16012464|NCT02793895|Device|CardioSTAT (Icentia Inc.) cardiac rhythm monitoring device|The CardioSTAT device is a wearable adhesive cardiac rhythm monitoring system which is low-profile, water-resistant, and is adhered onto the skin surface with 2 electrodes. This wearable adhesive device is designed for one-time use only. Each CardioSTAT device will provide 14 days of cardiac rhythm monitoring. For subjects randomized to the intervention group who will be monitored by the CardioSTAT device, they will receive 28 days of continuous cardiac rhythm monitoring.
16012465|NCT02793882|Drug|18F-Fluorocholine PET/CT|
16012466|NCT02793856|Drug|Cyclophosphamide|To deplete Tregs before collecting peripheral blood
16012467|NCT02793856|Other|PD-1 Knockout T Cells|Autologous lymphocytes are collected and PDCD1 gene is knocked out in the laboratory. Cells are selected and expanded ex vivo. Cells are infused back to the patients for treatment
16012468|NCT02793843|Drug|Ondansetron (Zofran)|Intravenous administration of 4 mg ondansetron 15 minutes before spinal anesthesia
16012469|NCT02793843|Drug|Dexamethasone (Decadron)|Intravenous administration of 8 mg dexamethasone 15 minutes before spinal anesthesia
16012470|NCT02793843|Other|Spinal anesthesia|Intrathecal anesthesia by 10 mg hyperbaric marcain, 5 mcg sufentanyl and 150 mcg morphine using 27 G spinal needle (27 G Quincke needle)
16012471|NCT02793830|Other|Daily reminders of taking medications|Reminders. Participants will receive medication-taking reminders from the researcher. These reminders are sent through the mobile application-BB Reminder on an unencrypted external device (a phone borrowed from Duke University School of Nursing and is used specifically for this study by the researcher). BB Reminder has the function that after inputting a patient's phone number and prescriptions, participants can receive reminders through text messages of the name, dosage, function, and administration route for every dose of his/her medications. The daily reminders will be sent to participants 15 minutes before every dose of their medications.
16012472|NCT02793830|Other|Educational materials|Educational materials. Participants will receive educational materials from the researcher. These educational materials will be sent through the mobile application-WeChat. The educational materials include short articles (< 500 words) and/or pictures. They will be retrieved from the Chinese Cardiovascular Disease-Prevention Information Website (www.healthyheart-china.com), which is governed by the Chinese Ministry of Health. The validity of information from it is guaranteed. The retrieved educational materials will be screened by the cardiologist, the head nurse, and the researcher, before sending to participants. The educational materials will be sent to participants every other day at any time during 8 am and 10 pm.
16012473|NCT02793817|Drug|KPI-121 1% Ophthalmic Suspension dosed BID|
16012474|NCT02793817|Drug|Vehicle of KPI-121 Ophthalmic Suspension dosed BID|
16012475|NCT02793804|Device|Oraquick (made in Thailand)|
16012476|NCT02793791|Procedure|minimally invasive ablation therapies|Including RFA (radiofrequency ablation);MWA (microwave ablation); PEI (percutaneous ethanol injection),etc.
16012477|NCT02793778|Drug|CROWN|A nutritionally based therapy, formulated as a powder, administered twice a day, preferable 1 hour before or more than 2 hours after meals, for up to 24 weeks
16012478|NCT02793778|Drug|CROWN Placebo|Placebo, formulated as a powder, administered twice a day, preferable 1 hour before or more than 2 hours after meals, for up to 24 weeks
16012479|NCT02793765|Drug|Docetaxel|
16012482|NCT02793739|Procedure|Hyaluronic acid filler injection|Hyaluronic acid filler will be injected into the dorsal fingers at day 0 and at day 14 if a touch-up is necessary.
16012483|NCT02793726|Procedure|NMR|
16012484|NCT02793713|Procedure|Endobronchial Ultrasound|Patients undergoing EBUS with TransBronchial Needle Aspiration will be invited to enroll on the day of their procedure. Once informed consent is obtained, the surgeon will assess the sonographic criteria, take pictures, and biopsy every lymph node of interest. All three elements of this assessment will need to be completed for a specimen to be included in the study. After the procedure, the operating surgeon will fill the Lymph Node Assessment questionnaire, assign an aggregate score to every lymph node specimen, and attach the pictures to the form. Pictures from every specimen will stored electronically to be reviewed and secondarily rated by a second blinded surgeon. Patient involvement in the study ends at the completion of the planned procedure.
16012485|NCT02793687|Drug|MEXIDOL® (ethylmethylhydroxypyridine succinate)|
16012486|NCT02793687|Other|Placebo|
16012487|NCT02793674|Device|Fisher & Paykel high flow nasal cannula|Measurements of effort of breathing will be obtained at flow rates of 0.5, 1.0, 1.5, and 2.0 L/kg/min. Adequate time will be allowed at each flow rate for stabilization of EOB and flow levels will be trialed in a random order, each being trialed for approximately 5 minutes.
16012488|NCT02793674|Device|Vapotherm high flow nasal cannula|Measurements of effort of breathing will be obtained at flow rates of 0.5, 1.0, 1.5, and 2.0 L/kg/min. Adequate time will be allowed at each flow rate for stabilization of EOB and flow levels will be trialed in a random order, each being trialed for approximately 5 minutes.
16012489|NCT02793661|Device|RenalGuard|Replacement of urine output by infusion of a matched volume of sterile replacement solution to maintain a patient's intravascular fluid volume. Diuretic is administered to reach an optimum urine flow and protect efficiently the patients' kidneys.
16012490|NCT02793661|Other|Control|Hydration protocol following ESC Guidelines 2014
16012491|NCT02793648|Drug|Ascorbic Acid|Two daily oral doses of 200mg of encapsulated vitamin C twice a day, administered at breakfast and dinner
16012492|NCT02793648|Drug|Alpha tocopherol|Two daily oral doses of 200mg of encapsulated vitamin E twice a day, administered at breakfast and dinner
16012493|NCT02793648|Drug|PLACEBO|Two daily oral doses of 200mg of encapsulated placebo, administered at breakfast and dinner
16012494|NCT02793635|Device|Indego Powered Exoskeleton|Subjects who have Spinal Cord Injury will wear the Indego device which will include being trained and evaluated for fifteen (15) sessions.
16012495|NCT02793622|Drug|Monthly Sulfadoxine-Pyrimethamine (SP) During Pregnancy|
16012496|NCT02793622|Drug|Monthly Dihydroartemisinin-Piperaquine (DP) During Pregnancy|
16012497|NCT02793609|Other|Intervention is to let patient to go home.|Intervention is to let patient to go home.
16012498|NCT02793609|Other|Intervention is to observe women in the ward.|Intervention is to observe women in the ward.
16012499|NCT02793596|Other|Obstetrical patients|Epidural waveform analysis as a confirmation of loss of Resistance
16012503|NCT02793570|Other|observational|
16012504|NCT02793557|Drug|FOL-005|Intradermal injection of 50 μl solution
16012505|NCT02793557|Other|Placebo|
16012506|NCT02793544|Drug|Fludarabine|"Fludarabine 30 mg/m2/day (adjusted for renal function) is administered over a 30-60 minute IV infusion on Days -6 through -2 (maximum cumulative dose, 150 mg/m2).
~The body surface area (BSA) for fludarabine dosing is based on adjusted ideal body weight (IBW) (Appendix K).
~creatinine clearance may change during the days fludarabine is given. Adjustment in fludarabine dose due to creatinine changes during conditioning is permitted."
16012507|NCT02793544|Drug|Cyclophosphamide 14.5 mg/kg/day IV on Days -6, -5|"Cy 14.5 mg/kg/day is administered as a 1-2 hour IV infusion on Days -6 and -5 after hydration.
~Use of Mesna and dosing will be done according to institutional standards. A recommended approach is as follows: Mesna IV dose of ≥ 80% of the total daily dose of Cy and given in divided doses 30 minutes before and at 3, 6, and 8-9 hours after completion of Cy.
~Hydration prior to Cy may be given according to institutional guideline.
~Cy and mesna are dosed according to adjusted IBW (Appendix K), unless the subject weighs less than IBW, in which case these drugs will be dosed according to actual weight."
16012508|NCT02793544|Radiation|Total Body Irradiation (TBI) 200cGy on Day -1|"200 cGy TBI is administered in a single fraction on Day -1.
~Radiation sources, dose rates, and shielding follow institutional practice."
16012509|NCT02793544|Procedure|Infusion of non-T-cell depleted bone marrow on Day 0|"On Day 0, the harvested bone marrow is infused.
~Donor bone marrow will be harvested with a target yield of 4 x 108 nucleated cells/kg recipient weight.
~The lowest acceptable nucleated cells yield is 1.5 x 108 cells/kg recipient weight."
16012510|NCT02793544|Drug|Busulfan|"Busulfan ≥ 9mg/kg total dose (IV or PO) on Days -6, -5, -4, -3 (PK monitoring required to achieve a daily area under the curve (AUC) target of 4800-5300 μM*min (Perkins et al., 2012))
~Busulfan dosing is based on adjusted IBW (Appendix K)"
16012511|NCT02793544|Drug|Cyclophosphamide 50mg/kg/day IV on Days -2,-1|"Cy 50mg/kg/day is administered as a 1-2 hour IV infusion on Days -2 and -1 after hydration.
~Use of Mesna and dosing will be done according to institutional standards. A recommended approach is as follows: Mesna IV dose of ≥ 80% of the total daily dose of Cy and given in divided doses 30 minutes before and at 3, 6, and 8-9 hours after completion of Cy.
~Hydration prior to Cy may be given according to institutional guideline.
~Cy and mesna are dosed according to adjusted IBW (Appendix K), unless the subject weighs less than IBW, in which case these drugs will be dosed according to actual weight."
16012512|NCT02793544|Drug|Cyclophosphamide 50mg/kg/day IV on Days -5,-4|"Cy 50mg/kg/day is administered as a 1-2 hour IV infusion on Days -5 and -4 after hydration.
~Use of Mesna and dosing will be done according to institutional standards. A recommended approach is as follows: Mesna IV dose of ≥ 80% of the total daily dose of Cy and given in divided doses 30 minutes before and at 3, 6, and 8-9 hours after completion of Cy.
~Hydration prior to Cy may be given according to institutional guideline.
~Cy and mesna are dosed according to adjusted IBW (Appendix K), unless the subject weighs less than IBW, in which case these drugs will be dosed according to actual weight."
16012513|NCT02793544|Radiation|Total Body Irradiation (TBI) 200cGy twice a day on Days -3, -2, -1|"200cGy TBI is administered in twice daily on Days -3, -2, and -1.
~Radiation sources, dose rates, and shielding follow institutional practice."
16013399|NCT02786901|Drug|Loteprednol Etabonate Ophthalmic Gel dosed BID|Gel
16012514|NCT02793544|Drug|Post-HCT Cyclophosphamide 50mg/kg IV on Day+3, +4|"Cy 50mg/kg IV, over 1-2 hours (depending on volume), is given on Day+3 (ideally between 60 and 72 hours after bone marrow infusion) and on Day+4 (approximately 24 hours after Day+3 Cy).
~Hydration with Cy, management of volume status, and monitoring for hemorrhagic cystitis will follow institutional standards.
~Mesna is required. Mesna IV dose must be ≥ 80% of the total daily dose of Cy and given in divided doses 30 minutes before and at 3, 6, and 8-9 hours after completion of Cy.
~Cy is dosed according to IBW, unless the subject weighs less than IBW, in which case these drugs will be dosed according to actual body weight."
16012515|NCT02793544|Drug|Sirolimus|"Sirolimus dosing is based on adjusted IBW (Appendix K).
~Sirolimus prophylaxis is discontinued after the last dose on Day+180, or may be continued if there is GVHD.
~For subjects ≥ 18 years old:
~A one-time sirolimus loading dose, 6 mg PO, is given on Day+5, at least 24 hours after Cy completion.
~Sirolimus is then continued at a maintenance dose (starting dose 2 mg PO QD), with dose adjustments to maintain a trough of 5 - 15 ng/mL as measured by high performance liquid chromatography (HPLC) or immunoassay.
~For subjects < 18 years old:
~A one-time sirolimus loading dose, 3 mg/m2 PO with the dose not to exceed 6 mg, is given on Day+5, at least 24 hours after Cy completion.
~Sirolimus is then continued at a maintenance dose (starting dose 1 mg/m2 PO QD, maximum 2 mg PO QD), with dose adjustments to maintain a trough of 5 - 15 ng/mL as measured by HPLC or immunoassay."
16012516|NCT02793544|Drug|Mycophenolate mofetil|"MMF begins on Day+5, at least 24 hours after completion of PTCy. MMF dose is 15 mg/kg PO TID (adjusted IBW (Appendix K)) with total daily dose not to exceed 3 grams (i.e. maximum 1 g PO TID).
~An equivalent IV dose (1:1 conversion) may instead be given. MMF prophylaxis is discontinued after the last dose on Day+35, or may be continued if there is GVHD."
16012517|NCT02793544|Drug|G-CSF|"Granulocyte-colony stimulating factor (G-CSF): filgrastim or a biosimilar begins on Day+5 at a dose of 5 mcg/kg/day (actual body weight) IV or subcutaneously (SC) (rounding to the nearest vial dose is allowed), until the absolute neutrophil count (ANC) is ≥ 1,000/mm3 over the course of 3 consecutive days.
~Additional G-CSF may be administered as warranted."
16012518|NCT02793544|Drug|Pre-HCT Mesna on Days -6 and -5|"Use of Mesna and dosing will be done according to institutional standards. A recommended approach is as follows: Mesna IV dose of ≥ 80% of the total daily dose of Cy and given in divided doses 30 minutes before and at 3, 6, and 8-9 hours after completion of Cy.
~Mesna is dosed according to adjusted IBW (Appendix K), unless the subject weighs less than IBW, in which case Mesna will be dosed according to actual weight."
16012519|NCT02793544|Drug|Pre-HCT Mesna on Days -2 and -1|"Use of Mesna and dosing will be done according to institutional standards. A recommended approach is as follows: Mesna IV dose of ≥ 80% of the total daily dose of Cy and given in divided doses 30 minutes before and at 3, 6, and 8-9 hours after completion of Cy.
~Mesna is dosed according to adjusted IBW (Appendix K), unless the subject weighs less than IBW, in which case Mesna will be dosed according to actual weight."
16012520|NCT02793544|Drug|Pre-HCT Mesna on Days -5 and -4|"Use of Mesna and dosing will be done according to institutional standards. A recommended approach is as follows: Mesna IV dose of ≥ 80% of the total daily dose of Cy and given in divided doses 30 minutes before and at 3, 6, and 8-9 hours after completion of Cy.
~Mesna is dosed according to adjusted IBW (Appendix K), unless the subject weighs less than IBW, in which case Mesna will be dosed according to actual weight."
16012521|NCT02793544|Drug|Post-HCT Mesna|"Mesna is required. Mesna IV dose must be ≥ 80% of the total daily dose of Cy and given in divided doses 30 minutes before and at 3, 6, and 8-9 hours after completion of Cy on Day+3 and Day+4.
~Mesna is dosed according to IBW, unless the subject weighs less than IBW, in which case Mesna will be dosed according to actual body weight."
16012522|NCT02793531|Other|Stable isotope amino acid infusion|such as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline
16012523|NCT02793518|Behavioral|psychological tests|
16012524|NCT02793505|Drug|metformin|This is not an intervention but an observed exposure.
16012525|NCT02793505|Drug|any drug not known as a major teratogen or major fetotoxicant|This is not an intervention but an observed exposure.
16012527|NCT02793466|Drug|Durvalumab; MEDI4736|IV Infusion every 2 weeks for a maximum of 26
16012528|NCT02793453|Other|periodontal smears|
16012529|NCT02793440|Other|cortivazol treatment|
16012530|NCT02793440|Other|lumbar traction|
16012531|NCT02793427|Biological|blood sample collection|
16012532|NCT02793401|Device|Hıgh İntensity Laser (HILT)|HILT was performed using a BTL-6000 High Intensity Laser, 12 W(watt), 1064 nm device was a hot laser with Nd: YAG LASER source. In HILT group, the investigators applied the device on the shoulder area in two phases: phase I - analgesia, and phase II - biostimulation.
16012533|NCT02793401|Device|Ultrasound|BTL 4710 US device was applied at 3 MHz frequency, and 1.5watt/cm2 intensity over 25 cm2 surface area. Headpiece area of the device was 5 cm2, and the application was performed as the head of device was positioned at 90º (perpendicular) at full contact for 5 minutes by using gel, and performing continuous circular motions.
16012534|NCT02793401|Device|Hotpack|All patients had the same physical therapy (PT) protocol including hot pack (HP) for 20 min/session,
16012535|NCT02793401|Device|Transcutaneous electrical nerve stimulation|All patients had the same physical therapy (PT) protocol includingTENS (Fizyotens 4000, Fizyomed Medical Devices Ltd,Turkey) (50-100 Hz) for 20 min/session,
16012536|NCT02793401|Other|Therapeutic exercises|All patients had the same physical therapy (PT) protocol including therapeutic exercises for shoulder muscles
16012537|NCT02793401|Other|Balneotherapy|All patients had the same physical therapy (PT) protocol including balneotherapy in 38-40 °C thermomineralized water for 20 minutes.
16012538|NCT02793388|Drug|Supervised primaquine treatment|Following schizontocidal treatment malaria patients (P. falciparum and P. vivax) will receive 14days primaquine treatment if found to be G6PD normal. Primaquine treatment is provided supervised every other day.
16012539|NCT02793388|Drug|Unsupervised primaquine treatment|Following schizontocidal treatment malaria patients (P. falciparum and P. vivax) will receive 14days primaquine treatment if found to be G6PD normal. Primaquine treatment is provided unsupervised.
16012540|NCT02793375|Drug|Montelukast|Age appropriate dose of Montelukast given to patients prior to undergoing adenotonsillectomy, and the day after surgery, with pain scores and amount of opioid pain medication required measured postoperatively.
16013400|NCT02786901|Drug|Vehicle Gel|Gel
16012541|NCT02793375|Drug|Placebo|Age appropriate dose of placebo given to patients prior to undergoing adenotonsillectomy, and the day after surgery, with pain scores and amount of opioid pain medication required measured postoperatively.
16012542|NCT02793349|Device|Absorb Bioresorbable Vascular Scaffold|Absorb Bioresorbable Vascular Scaffold
16012543|NCT02793323|Other|Superficial cervical nerve block|A nerve stimulator is used to guide superficial cervical blockade to relieve shoulder pain.
16012544|NCT02793323|Other|NSAID|100 mg (100 ml) intravenous NSAIDs (Profenid)
16012545|NCT02793323|Other|General anesthesia|General anesthesia is induced with 1 μg/kg fentanyl, 1.5-2 mg/kg propofol and 1-2 mg midazolam. Then, endotracheal intubation is facilitated by 0.15 mg/kg nimbex. Anesthesia is maintained by 1-1.5% sevoflurane, 0.5 μg/kg/h fentanyl, 0.05 mg/kg/h nimbex, 60% nitrous oxide and 40% oxygen
16012546|NCT02793323|Other|IV placebo|100 ml IV saline
16012547|NCT02793323|Other|Placebo superficial cervical nerve block|Superficial cervical nerve block containing 5 ml saline
16012548|NCT02793310|Procedure|DMEK|The intervention group will receive cornea transplantation by DMEK
16012549|NCT02793310|Procedure|DSAEK|The usual care / control group will receive cornea transplantation by DSAEK
16012550|NCT02793297|Other|refined wheat crisp bread|Refined wheat crisp bread (52 g) was served as part of a regular breakfast together with margarine (15 g), cheese (20 mg), coffee/tea (150 mL), and juice (150 mL). The amount of crisp bread was adjusted so that all arms provided a similar amount of available carbohydrate (35 g).
16012551|NCT02793297|Other|sourdough fermented rye crisp bread|Sourdough fermented rye crisp bread (59.4 g) was served as part of a regular breakfast together with margarine (15 g), cheese (20 mg), coffee/tea (150 mL), and juice (150 mL). The amount of crisp bread was adjusted so that all arms provided a similar amount of available carbohydrate (35 g).
16012552|NCT02793297|Other|unfermented rye crisp bread|Unfermented rye crisp bread (59.8 g) was served as part of a regular breakfast together with margarine (15 g), cheese (20 mg), coffee/tea (150 mL), and juice (150 mL). The amount of crisp bread was adjusted so that all arms provided a similar amount of available carbohydrate (35 g).
16012553|NCT02793284|Radiation|18F-DCFPyL PET/CT scan|PET/CT scan using the radioactive agent 18F-DCFPyL
16012554|NCT02793271|Behavioral|RESHAPE|Mental health services users and primary care workers who have previously completed the training are trained using PhotoVoice and other techniques to participate as co-facilitators. They participate in introductions to the intervention, myth busting, recovery stories, psychosocial communication role plays, and collaborative activities addressing challenges and barriers to task sharing/ task shifting mental health services in primary care.
16012555|NCT02793271|Behavioral|PRIME/mhGAP|"Primary care workers are trained using the mental health Global Action Programme (mhGAP) to identify and treat mental disorders in primary care. Primary care prescribers (those who can administer psychotropic medication) are trained to treat disorders including depression, alcohol use disorder, psychosis / schizophrenia, and epilepsy. Non-prescribers (primary care workers not authorized to dispense medications) are trained to deliver psychosocial and psychological interventions."
16012556|NCT02793258|Device|transcranial direct current stimulation|"Subjects will receive 10 30-minutes sessions of two milliamps transcranial direct current stimulation , twice a day for 5 consecutive day.
~Facial emotion recognition task and attentional task with measurement of eye-tracking, heartrate, respiratory frequency and skin conductance will be conducted before and after the first session, and after the last session."
16012557|NCT02793245|Other|Questionnaire|Questionnaire on their main characteristics : age, gender, height, weight, smoking
16012558|NCT02793245|Other|Simplified pulmonary function test|
16012559|NCT02793232|Drug|PF-06751979 single dose|PF-06751979 administered as a single dose suspension in cross-over fashion. Each subject may receive up to 4 study treatments (placebo and up to 3 doses of PF 06751979). The planned dose levels are 200 mg, 400 mg, 700 mg, 200 mg fed (these doses are subject to change based on emerging data).
16012560|NCT02793232|Drug|Placebo single dose|Matched Placebo suspension administered as single dose
16012561|NCT02793232|Drug|PF-06751979 multiple ascending dose|PF-06751979 suspension administered daily for 14 consecutive days to parallel cohorts. The planned dose levels are mg, 100 mg, 200 mg, 340 mg (these are subject to change based on emerging data).
16012562|NCT02793232|Drug|Placebo multiple ascending dose|Matched placebo suspension administered daily for 14 consecutive days.
16012563|NCT02793232|Drug|PF-06751979 multiple dose|PF-06751979 suspension administered daily for 14 consecutive days. The planned dose level is 340 mg (this is subject to change based on emerging data).
16012564|NCT02793232|Drug|Placebo multiple elderly dose|Multiple dose administration to Healthy Elderly Subjects (Placebo)
16012565|NCT02793219|Biological|Sipuleucel-T|
16012566|NCT02793219|Drug|Docetaxel|
16012567|NCT02793206|Device|Imaging|
16012568|NCT02793193|Dietary Supplement|Probiotic|Probiotic B.longum 1714 will be donated by Alimentary Health Ltd. (Cork, Ireland) and each sachet contains 10 billion CFU
16012569|NCT02793193|Dietary Supplement|Placebo for antibiotic|The placebo supplementation is identical-looking to the antibiotic Xifaxan ®
16012570|NCT02793193|Drug|Antibiotic|Antibiotic Xifaxan ® will be 200mg per tablet
16012571|NCT02793193|Dietary Supplement|Placebo for probiotic|The placebo identical-looking to the probiotic B.longum 1714
16012572|NCT02793167|Device|AKI alert|
16012573|NCT02793154|Drug|Exenatide|Supplied as SC injection containing 250 mcg/mL of exenatide, provided in the following dose regimens: Part A: 10 mcg taken twice daily for 5 days; Part B: 5 mcg twice daily taken for 4 weeks followed by uptitration to 10 mcg for 4 weeks In both parts, it will be administered within 60-minute period before morning and evening meals (or before 2 meals with approximate >=6 hours apart)
16012574|NCT02793154|Drug|Albiglutide|Part B: Albiglutide will be supplied as follows:30 mg SC injection pen containing 40.3 mg lyophilized albiglutide and 0.65 mL; 50 mg SC injection pen contains 67 mg lyophilized albiglutide and 0.65 mL water; Starting dose will be 30 mg weekly for 4 weeks and then uptitrated to 50 mg weekly for 4 weeks; Administered as a single SC injection once a week in the morning
16012575|NCT02793141|Other|No intervention|No intervention will be administered
16012576|NCT02793128|Drug|UGN-101 instillations|Treatment with UGN-101 once weekly for a total of 6 times; in a retrograde fashion. Patients who will demonstrate complete response (CR) will be treated with UGN-101 once monthly as a maintenance therapy for a total of 11 instillations or up to the first recurrence whichever comes first.
16012577|NCT02793115|Behavioral|Disclosure Letter-RISKS|This disclosure letter will provide information on the physicians' financial relationships with industry, and will also provide a standardized statement regarding the potential RISKS of physicians' conflicts of interest with for-profit industry. This letter also includes a standard statement reminding the patient about the appointment and the location of the appointment.
16012578|NCT02793115|Behavioral|Disclosure Letter-BENEFITS|This disclosure letter will provide information on the physicians' financial relationships with industry, and will also provide a standardized statement regarding the potential BENEFITS of physicians' conflicts of interest with for-profit industry. This letter also includes a standard statement reminding the patient about the appointment and the location of the appointment.
16012579|NCT02793115|Behavioral|Disclosure Letter-RISKS AND BENEFITS|This disclosure letter will provide information on the physicians' financial relationships with industry, and will also provide a standardized statement regarding the potential RISKS AND BENEFITS of physicians' conflicts of interest with for-profit industry. This letter also includes a standard statement reminding the patient about the appointment and the location of the appointment.
16012580|NCT02793115|Behavioral|Disclosure Letter-NO RISKS OR BENEFITS|This letter includes a standard statement reminding the patient about the appointment and the location of the appointment.and DOES NOT provide any information on the physicians' financial relationships with industry nor information regarding the potential risks and benefits of physicians' conflicts of interest with for-profit industry.
16012581|NCT02793115|Behavioral|Letter-APPOINTMENT REMINDER|This letter only includes a standard statement reminding the patient about the appointment and the location of the appointment.
16012582|NCT02793102|Other|Olfactory workshop|Twenty odorants are selected: 10 evoke a food (including 5 pleasant and unpleasant 5) and 10 suggest a non-food source
16012583|NCT02793102|Other|Somesthesia workshop|Kinesthetic time or time for moving the body (30 min), and kinesthetic sensations (duration 10 min), and Talk Time
16012584|NCT02793102|Other|Auditory workshop|Twenty extracts of music tracks (30 seconds each) are built in the same fashion as those used during the workshops, but are different.
16012585|NCT02793089|Other|Analysis of Ectopic Pregnancy incidence|Collect retrospectively data. Analysis of Ectopic Pregnancy incidence through Estradiol (E2) and progesterone (P4) levels on hCG day and seven days later (hCG+7)
16012586|NCT02793076|Other|Bollywood Dance|8 week Bollywood Dance Program
16012587|NCT02793063|Other|Web-based Survey|This study will occur online. Participants will be asked to complete multiple surveys one time. Participants may receive study reminder emails to complete surveys. Participants will be able to complete the surveys all at once or in multiple sessions. Participants will have approximately 3 months to complete the surveys after consenting.
16012588|NCT02793050|Drug|Trabectedin|Collection of data on the clinical use of Trabectedin
16012589|NCT02793037|Device|Zirconia resin bonded bridge|
16012590|NCT02793024|Behavioral|Intervention|Adolescents in the intervention arm will receive 3 face to face session about making smart shopping choices. The following 9 weeks will consist of utilizing social media to improve shopping choices.
16012591|NCT02793011|Drug|Dexamethasone|Oral dexamethasone elixir (0.5mg/ml or 4 mg/ml) mixed with Ora-sweet or simple syrup to mask the taste. Or 1 mg or 4 mg dexamethasone capsules if age appropriate
16012592|NCT02793011|Drug|Placebo|Placebo liquid (Ora-sweet or simple syrup) or Placebo capsule
16012593|NCT02792998|Drug|IW-1701|IW-1701 Tablet
16012594|NCT02792998|Drug|Placebo|Matching Placebo Tablet
16012595|NCT02792985|Behavioral|Multisensory stimulation protocol|"Participation in occupation-based multisensory stimulation (e.g. personal care with aromatic soaps, varying water temperatures and textured sponges, drink preparation of different flavoured beverages) with a variety of different sensory stimuli (e.g. strong smells, different shapes and weights). The participant will receive two individual 30-minute therapy sessions with an Occupational Therapist.
~An enriched environment will be set up in the participant´s bedroom. It will include items that provide a range of meaningful sensory stimuli (e.g. familiar personal objects, projection of photos and known places, familiar music). The participant is encouraged to follow a timetable including regular rest breaks through out the day in their room."
16012596|NCT02792985|Behavioral|Control protocol|"Retraining of basic activities of daily living or participation in table top tasks and games in an individual 30 minute session or a one hour small group session with an Occupational Therapist.
~Minimal changes are made to the participant´s room (e.g. orientation board, photos of family and friends)."
16012597|NCT02792972|Other|A. oleracea|The plant extract A. oleracea manipulated with Transcutol® were used in the volunteers before the venipuncture procedure as allocation in study groups. Held collection of skin microbiota by the swab technique and the end of the venipuncture procedure was applied to the volunteer, the visual numeric scale (VNS) standard to determine the degree of pain.
16012598|NCT02792972|Other|70% alcohol|70% alcohol were used in the volunteers before the venipuncture procedure as allocation in study groups. Held collection of skin microbiota by the swab technique and the end of the venipuncture procedure was applied to the volunteer, the visual numeric scale (VNS) standard to determine the degree of pain.
16012599|NCT02792959|Device|Functional Imaging previous the second course|Functional Imaging before and after 1 cycle of chemotherapy treatment, in the previous 4 days before the second course: PET1 and MRI1
16012600|NCT02792959|Device|Functional Imaging previous the surgery|Functional Imaging after 4 cycles of chemotherapy treatment, in the 3 weeks after the chemotherapy, before the interval surgery: PET4 and MRI4 The RECIST evaluation will be done, usually, by scanner to 4 courses of chemotherapy before the surgery interval
16012601|NCT02792946|Drug|Acebrophylline|
16012602|NCT02792933|Procedure|air in epidural space|The epidural puncture will be performed in the L3-L4 or L4-L5 interspinous space in a seated position. A local anaesthesia with 2-5 mL of 2% lidocaine will be applied subcutaneously using a 25Gm 25mm needle. The epidural space will be localized using a Perifix® set by inserting the Tuohy needle in the ligamentum flavum or the interspinous space. The obturator will be then withdrawn and the low resistance syringe filled with 3-5mL of air will be connected. After localizing the epidural space, the catheter will be inserted 3-5 cm. An aspiration test will be performed through the catheter in a decline position with a 2 mL syringe, and a 3mL test dose with bupivacaine 0,25% plus epinephrine 1/200.000 will be administered to exclude an intradural or an intravascular position of the catheter.
16012830|NCT02791178|Other|Cardiac MRI|Special scanner if the heart to assess the damage of your heart
16012603|NCT02792933|Procedure|saline in epidural space|The epidural puncture will be performed in the L3-L4 or L4-L5 interspinous space in a seated position. A local anaesthesia with 2-5 mL of 2% lidocaine will be applied subcutaneously using a 25Gm 25mm needle. The epidural space will be localized using a Perifix® set by inserting the Tuohy needle in the ligamentum flavum or the interspinous space. The obturator will be withdrawn and the low resistance syringe filled with 3-5mL of saline solution will be connected. After localizing the epidural space, the catheter will be inserted 3-5 cm. An aspiration test will be performed through the catheter in a decline position with a 2 mL syringe, and a 3mL test dose with bupivacaine 0,25% plus epinephrine 1/200.000 will be administered to exclude an intradural or an intravascular position of the catheter.
16012604|NCT02792920|Device|CoCr-EES|
16012605|NCT02792907|Device|Compressive stocking|"After hindfoot and middlefoot surgery the patients from the Intervention Group will be treated with compressive stockings the removal of the suture. That means from the end of week 2 until the end of week 6 after surgery.
~Additionally the patients wearing behaviour is monitored by a electronic sensor, which is implanted in the patient´s stocking."
16012606|NCT02792894|Behavioral|Family networks program|Intervention, Family networks Program (FaNs), is administered once weekly over 9-10 weeks in a group format over 3 hours per sessions. Family networks Program (FaNs) is based on WHO mhGAP module for developmental disorders and incorporates WHO parent skills training program for children with developmental disorders and delays. Parents Skills Training Program includes modules on communication, play, daily living skills, managing challenging behavior, coping with stress. Intervention is provided by the family volunteers (members of community, mostly women, who have a child affected in their families).
16012607|NCT02792881|Procedure|Laparoscopic total gastrectomy with D2 lymphadenectomy|After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic total gastrectomy with D2 lymphadenectomy will be performed with curative treated intent.For carcinomas arising in the remnant stomach with a gastrojejunostomy, jejunal lymph nodes adjacent to the anastomosis are included as regional lymph nodes. The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy
16012608|NCT02792868|Other|24 h urines analyses|patient collects urines during 24h
16012609|NCT02792855|Device|snifﬁng Position(place a 7-cm cushion under head )|Awake fiberoptic bronchoscope(FOB) orotracheal under snifﬁng position.The snifﬁng position was obtained by placement of a 7-cm cushion under the head of the patient. When the FOB was inserted into oral cavity, and the epiglottis and glottis were identified by the FOB. The anterior of FOB was inserted deep into tracheal after the glottis was exposed sufficiently then the tracheal tube was pushed into the trachea via the FOB
16012610|NCT02792855|Device|Simple Head Extension(without cushion)|Awake fiberoptic bronchoscope(FOB) orotracheal under Head Extension position.The Head Extension position was obtained by simple head extension.When the FOB was inserted into oral cavity, and the epiglottis and glottis were identified by the FOB. The anterior of FOB was inserted deep into tracheal after the glottis was exposed sufficiently then the tracheal tube was pushed into the trachea via the FOB
16012611|NCT02792842|Drug|ART-123 (3-day ART)|ART-123 380 U/kg infusion once daily on days 1-3 in each cycle
16012612|NCT02792842|Drug|ART-123 (1-day ART)|ART-123 380 U/kg infusion once on day 1 and placebo infusion once daily on days 2-3 in each cycle
16012613|NCT02792842|Drug|Placebo|Placebo infusion once daily on days 1-3 in each cycle
16012614|NCT02792829|Drug|Lenvatinib|All participants will receive one single dose in each of the 2 treatment periods (total of 2 doses). The total duration of the treatment periods is 12 days (6 days per period) in healthy adult volunteers.
16012615|NCT02792816|Drug|First line antimalarial in Myanmar (artemether-lumefrantrine, dihydroartemisinin-piperaquine, and artesunate-mefloquine)|Being a observational cohort study, one of the ACT was selected in each study site to assess the efficacy and safety.
16012616|NCT02792803|Drug|Xalatan|A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma.
16012617|NCT02792803|Drug|Apo-Latanoprost|A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma.
16012618|NCT02792803|Drug|Co-Latanoprost|A prostaglandin analogue used to reduce intraocular pressure in patients diagnosed with glaucoma.
16012619|NCT02792777|Other|Interviews|Patients will be engaged in open-ended, semi-structured qualitative interviews, which will be performed one-on-one either in person or over the phone (depending on the healthcare setting that they are recruited from). Qualitative interviews will be audio recorded, with the patient's permission, transcribed, de-identified and entered into NVivo software for coding and analysis.
16012620|NCT02792777|Other|Concept Mapping (CM)|"The CM process consists of 3 steps that take place over 3 sessions:
~Step 1: Generation of Ideas- Participants brainstorm and generate responses to the focus statement. Once the group agrees that no new statements are being generated, the list of statements is reviewed within the group.
~Step 2: Structuring of Statements- Each participant is given a set of sort cards and asked to sort the statements into piles. Participants then rate each idea regarding importance. Research staff enters this information into the CM software.
~Concept Systems Global Software generates point maps using a technique that detects underlying similarities/differences between statements. The CM software then uses hierarchical cluster analysis to draw boundaries around the point map to create conceptual clusters.
~Step 3: Interpretation- The CM group revises the concept map. Participants review the cluster names suggested by the software and decide upon final naming of each cluster as a group."
16012621|NCT02792751|Device|Bispectral Index Monitorisation (BIS)|Standard monitoring was performed with electrocardiography, pulse oximetry and non invasive blood pressure. Additionally, Bispectral index (Aspect Medical Systems, Natica, MA) electrodes were connected to Group B patients
16012622|NCT02792751|Other|Ramsey Sedation Scale|Propofol administration was done to keep the Ramsey Sedation scale of 3 or 4
16012623|NCT02792738|Behavioral|hypnosis|
16012624|NCT02792725|Drug|Abemaciclib|Administered orally
16012625|NCT02792712|Drug|Ticagrelor|Ticagrelor 180 mg LD，then 90 mg BID
16012626|NCT02792712|Drug|Clopidogrel|Clopidogrel 300 mg LD，then 75 mg QD
16012627|NCT02792699|Drug|ABP 798|Supplied as a 10 mg/mL liquid concentrate for intravenous (IV) administration.
16012628|NCT02792699|Drug|Rituximab (US)|Supplied as a 10 mg/mL liquid concentrate for IV administration.
16012629|NCT02792699|Drug|Rituximab (EU)|Supplied as a 10 mg/mL liquid concentrate for IV administration.
16012630|NCT02792686|Drug|ABX464|Single Administration
16012631|NCT02792673|Other|embryos will be transferred using a medium of 0.5 mg/mL of Hyaluronan-enriched medium (EmbryoGlue®, Vitrolife, Sweden)|
16012632|NCT02792673|Other|embryos will be transferred using a medium of 30% Protein-supplemented Culture Medium (Global total®, Life Global group, Canada)|
16012633|NCT02792673|Other|a novel technique in which embryos will be transferred using a medium of autologous Follicular Fluid|
16012634|NCT02792673|Device|Labotect embryo transfer catheter|
16012635|NCT02792660|Device|Injeq IQ-Needle|Injeq IQ-Needle is a spinal needle that has bioimpedance measurement capability. It consists of traditional needle cannulae and removable bioimpedance probe which enables the measurement of bioimpedance. The needle is connected to measurement device and tissue identifying algorithm. Bioimpedance is measured during the operation and the algorithm detects when the needle tip is in contact with cerebrospinal fluid.
16012636|NCT02792647|Drug|Placebo|Administered orally
16012637|NCT02792647|Drug|IX-01|Administered orally
16012638|NCT02792634|Procedure|Sleeve-Gastrectomy, Roux en Y gastric bypass|
16012639|NCT02792621|Dietary Supplement|Acipimox|Oral supplement containing Acipimox 250mgs as the active ingredient in blinded label tablet form.
16012640|NCT02792621|Dietary Supplement|placebo|The placebo supplement will contain only cellulose microcrystalline. This is an inert substance widely used in many pill and tablet formulations. It is an insoluble fibre and is not absorbed into the blood stream therefore is unlikely to cause toxicity when taken orally.
16012641|NCT02792608|Behavioral|Mindfulness-based Therapy|MBT will be delivered in group format, 135 minutes per week, for 5 consecutive weeks with 10-20 participants per group.
16012642|NCT02792595|Other|Negative Control|Untreated area
16012643|NCT02792595|Other|Positive Control|High SPF Standard P3/SPF 15
16012644|NCT02792595|Other|Test Product A|Yosemite Falls (Forte Day SPF upgrade) Variant A
16012645|NCT02792595|Other|Test Product B|Yosemite Falls (Forte Day SPF upgrade) Variant B
16012646|NCT02792595|Other|Test Product C|Yosemite Falls (Forte Day SPF upgrade) Variant C
16012647|NCT02792595|Other|Test Product D|Yosemite Falls (Forte Day SPF upgrade) Variant D
16012648|NCT02792595|Other|Test Product E|Yosemite Falls (Forte Day SPF upgrade) Variant E
16012649|NCT02792595|Other|Test Product F|Yosemite Falls (Forte Day SPF upgrade) Variant F
16012650|NCT02792595|Other|Test Product G|Yosemite Falls (Forte Day SPF upgrade) Variant G
16012651|NCT02792595|Other|Test Product H|Yosemite Falls (Forte Day SPF upgrade) Variant H
16012652|NCT02792582|Radiation|Proton Therapy|The protocol-specific radiation dose will be prescribed to a target defined by the use of computerized tomography (CT) and magnetic resonance imaging (MRI). The target will encompass the residual tumor and/or tumor bed and will include a margin mean to treat subclinical microscopic disease. There is no time limit for the interval from surgery or study enrollment to when proton therapy commences. The time course of administration of proton therapy will be 1 treatment/day, 5 days/week, for a period 6 weeks.
16012653|NCT02792582|Procedure|Surgery|When possible, tumors will be removed surgically prior to proton therapy. If no tumor remains following surgery, no proton therapy will be given, and participants will be followed for 5 years to collect outcome data for comparison between groups.
16012654|NCT02792569|Procedure|Biopsy of ovarian cortical tissue|Biopsies will be taken from either right or left side. The cortical tissue will be isolated and fragmented in 1x1 mm2 pieces, followed by auto-transplantation to a peritoneal pocket.
16012655|NCT02792556|Device|Urine pregnancy test|Urine pregnancy test Check Top after transvaginal ultrasound
16012656|NCT02792543|Device|Entéromate™|Chyme reinfusion (the experimental treatment) consists of continuously reinfusing the chyme collected from the proximal small bowel segment via the enterostomy, and into the diverted distal small bowel segment. It implies the use of the Entéromate™ pump.
16012657|NCT02792543|Drug|parenteral nutrition|Parenteral nutrition (the gold standard treatment) consists of electrolyte supplementation, hydration, and nutrition through a central venous catheter.
16012658|NCT02792530|Other|Dietary consultation|Dietary consultation for sodium restriction to decrease dietary intake to 2 grams/day less than the patients consume currently
16012659|NCT02792517|Drug|Erenumab|A single dose of erenumab administered in the abdomen.
16012660|NCT02792517|Drug|Ethynil Estradiol/Norgestimate Oral Contraceptive|Ethynil estradiol (EE)/norgestimate combination oral contraceptive is a 28-tablet cycle in which 1 oral tablet is taken daily; each containing 0.250 mg norgestimate and 0.035 mg EE for 21 days, after which a tablet only containing inert ingredients is taken for last 7 days of the 28 day cycle.
16012661|NCT02792491|Drug|Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone|Reduced dose of Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone
16012662|NCT02792465|Drug|CFI-402257|
16012663|NCT02792465|Drug|Fulvestrant|
16012664|NCT02792426|Drug|Research ENDS S-TA-U001|
16012665|NCT02792426|Drug|Nicorette Inhalator|
16012666|NCT02792413|Drug|Denosumab|Patients will receive a subcutaneous injection of Denosumab every 6 months for the duration of the study. In addition, they will receive vitamin D and calcium (which is the normal treatment) for the duration of the study.
16012667|NCT02792413|Drug|NaCl (placebo)|Patients will receive a subcutaneous injection of NaCl every 6 months for the duration of the study. In addition, they will receive vitamin D and calcium (which is the normal treatment) for the duration of the study.
16012668|NCT02792400|Drug|LY2403021|Glucagon receptor antagonist
16012669|NCT02792400|Drug|LY2403021 placebo|
16012670|NCT02792400|Procedure|Standardised liquid meal|
16012671|NCT02792400|Drug|Linagliptin|DPP-4-inhibitor
16012672|NCT02792400|Drug|Linagliptin placebo|
16012673|NCT02792400|Drug|Empagliflozin|SGLT2-inhibitor
16012674|NCT02792400|Drug|Empagliflozin placebo|
16012675|NCT02792387|Other|CVP measurement|CVP measurements had been performed with an electronic pressure transducer in spontaneously breathing non-ventilated patients. Central vein access was established trough the subclavian or internal jugular veins. Mean CVP was recorded for each patient, measured in mmHg.
16012676|NCT02792374|Other|Psychological Measurement|Measurement of psychological status in three levels: discrete symptom level, dimensional level, global level as measured by the scale
16013022|NCT02789813|Drug|Placebo|Once oral administration of 500mg before exposure therapy.
16012677|NCT02792361|Procedure|Standard Suction Drain|The intervention of the experimental group will be a standard suction drain placed at the surgical site following a Pterional Craniotomy.
16012678|NCT02792348|Other|Laboratory biomarker analysis on urine sample|Archived urine samples are analyzed for specific metabolite patterns by nuclear magnetic resonance
16012679|NCT02792335|Drug|apixaban|
16012680|NCT02792335|Drug|dabigatran|
16012681|NCT02792335|Drug|rivaroxaban|
16012682|NCT02792335|Drug|warfarin|
16012683|NCT02792322|Device|Transoral Robotic Surgery (TORS) with the daVinci Robotic Surgical System device|Patient's will be having TORS surgery in a seated position
16012684|NCT02792309|Behavioral|MotherWise Program|Healthy Marriage or Relationship Education services for pregnant women.
16012685|NCT02792296|Other|Project: EVO Monitor|Project: EVO Monitor was designed to incorporate a proprietary multi-tasking assessment into a state-of-the-art mobile video game-like platform, which deploys modern videogame graphics, engaging reward loops, and real-time adaptive mechanics to dynamically personalize difficulty in order to assess the user's ability.
16012686|NCT02792283|Biological|whole blood collection|
16012687|NCT02792270|Other|Caloric Restriction Diet|"A nutritional supplement called Scandishake (Nutridrinks, Perivale, UK) will be used for 3 days before surgery.
~- Scandishake will be mixed with 8 oz of whole fat cow milk, whole fat lactaid milk, almond milk or soy milk. The proposed macronutrient profile for the 3 days of caloric restriction (CR) is: 45% fat, 46% carbohydrate, and 8% protein."
16012688|NCT02792257|Drug|Dronabinol (Marinol®)|5mg - 10mg daily dose
16012689|NCT02792257|Drug|Placebo|Daily dose
16012690|NCT02792231|Drug|Ofatumumab subcutaneous injection|Ofatumumab 20 mg prefilled syringes for subcutaneous injection on days 1, 7, 14, week 4 and every 4 weeks thereafter
16012691|NCT02792231|Drug|Teriflunomide-matching placebo capsules|Placebo capsule, matching in appearance to teriflunomide, taken orally once daily
16012692|NCT02792231|Drug|Teriflunomide capsule|Teriflunomide 14 mg oral capsule taken once daily
16012693|NCT02792231|Drug|Matching placebo of ofatumumab subcutaneous injections|Matching placebo of ofatumumab subcutaneous injections on days 1, 7, 14, week 4 and every 4 weeks thereafter
16012694|NCT02792218|Drug|Ofatumumab subcutaneous injection|Ofatumumab 20 mg pre-filled syringes for subcutaneous injection on days 1, 7, 14, week 4 and every 4 weeks thereafter
16012695|NCT02792218|Drug|Teriflunomide-matching placebo capsules|Placebo capsule, matching in appearance to teriflunomide, taken orally once daily
16012696|NCT02792218|Drug|Teriflunomide capsule|Teriflunomide 14 mg oral capsule taken once daily
16012697|NCT02792218|Drug|Matching placebo of ofatumumab subcutaneous injections|Matching placebo of ofatumumab subcutaneous injections on days 1, 7, 14, week 4 and every 4 weeks thereafter
16012698|NCT02792205|Other|Non interventional study|no intervention
16012701|NCT02792179|Drug|[18F]RO6958948|Radiolabeled low molecular weight compound, administered as single IV injection. The mass dose of [18F]RO6958948 injected will be less than or equal to (</=) 10 micrograms (µg), injection volume </=20 mL. Target injected activity for [18F]RO6958948 will be 370 megaBecquerel (MBq) (10 millicurie [mCi]).
16012702|NCT02792166|Procedure|BPD-DS|Biliopancreatic Diversion with Duodenal Switch
16012703|NCT02792166|Procedure|SADI-S|Single Anastomosis Duodeno-ileal Bypass with Sleeve Gastrectomy
16012704|NCT02792153|Drug|Estradiol|AN participants will be prescribed 28 days of transdermal estradiol 0.1 mg/d (Days 1-28) plus 10 days (days 21-31) oral medroxyprogesterone 2.5 mg/d.
16012705|NCT02792140|Drug|Naltrexone|one week
16012706|NCT02792140|Other|Placebo|one week
16012707|NCT02792127|Behavioral|Online Program for Social Anxiety|This program will be completed from participants' homes using their own computers. This online format is based on a Cognitive Behaviour Therapy framework (CBT) and involves seven modules that ask participants to engage in a variety of thinking exercises and activities.
16012708|NCT02792114|Drug|Cyclophosphamide|
16012709|NCT02792114|Biological|Mesothelin-targeted T cells|
16012710|NCT02792114|Drug|AP1903|
16012711|NCT02792088|Drug|Besifovir 150mg|Besifovir 150 mg q.d. + Placebo of Tenofovir Disoproxil Fumarate 300 mg q.d. + L-carnitine (L-Carn Tab. 330 mg) 660 mg q.d.
16012712|NCT02792088|Drug|Tenofovir 300mg|Placebo of Besifovir 150 mg q.d. + Tenofovir Disoproxil Fumarate 300 mg q.d. + Placebo of L-carnitine (L-Carn Tab. 330 mg) 660 mg q.d.
16012713|NCT02792075|Other|5-year Follow-up|
16012714|NCT02792062|Drug|TAK-385 40 mg|TAK-385 40 mg tablet
16012715|NCT02792049|Device|Modified Ambu Spur II bag valve mask|Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a modified Ambu Spur II bag valve mask with integrated internal handle
16012716|NCT02792049|Device|Conventional Ambu Spur II bag valve mask|Subjects deliver breaths to manikin (IngMar RespiTrainer manikin model) a conventional Ambu Spur II bag valve mask
16012717|NCT02792036|Drug|Carboplatin|"Carboplatin will be given intravitreally. Participants are eligible to receive up to 8 injections per eye (once approximately every 14 days) based on lack of toxicity and evidence of tumor response. An injection of consolidation will be given once a complete response is observed. If further regression of stable seeds is noted, additional injections (up to 8 maximum per eye) will be provided at the discretion of the treating team. Injections could be repeated if vitreous recurrence occurs from another source (and patient has not reached 8 max limit per eye)."
16012718|NCT02792036|Drug|Maxitrol®|Maxitrol® contains neomycin and polymyxin B sulfates and dexamethasone ophthalmic suspension and is for topical ophthalmic use only. It will be given for continued use for five days following the carboplatin injection to prevent infection.
16012719|NCT02792036|Procedure|Focal Therapy|Simultaneously with intravitreal carboplatin, focal therapy will be applied as needed to eradicate the retinal source of the seeding as well as all epiretinal and subretinal active tumors at the discretion of the treating ocular oncologist.
16012720|NCT02792036|Procedure|Plaque Radiotherapy|Participants who have developed progressive disease despite focal (non-irradiative) therapy will receive brachytherapy determined by consensus between the treating ophthalmologist and radiation oncologist.
16012721|NCT02792023|Other|Immunochemical fecal occult blood test|Participants will be provided with a single immunochemical fecal occult blood test. Participants will introduce a small sample of feces inside and bring the test to the hospital
16012722|NCT02792023|Device|Colonoscopy|A colonoscopy (procedure performed using a scope design to examine the large bowel) will be offered to the participants
16012723|NCT02792023|Device|Upper endoscopy|An upper endoscopy (procedure performed using a scope to examine the upper digestive tract) will be offered to the participants
16012724|NCT02792010|Device|Hip cartilage MRI|Hip cartilage MRI
16012725|NCT02791997|Other|Neuropsychological tests|Neuropsychological tests consist in listening to sounds in various contexts and providing behavioral responses with response-buttons.
16012726|NCT02791997|Other|Neurophysiological tests|Neurophysiological tests consist in the recording of EEG and/or MEG signals while realizing the neuropsychological tests, as well as MRI scanning to characterize the patients' brain lesions and reconstruct the brain sources of surface EEG/MEG signals.
16012727|NCT02791984|Device|Fluid challenge with 250 ml of Ringer Lactate|"Fluid challenge with 250 ml of Ringer Lactate over less than 2 minutes, intra-venous, help by a syringe of 50 ml.
~Measure of peak velocity before and after the fluid challenge"
16012728|NCT02791971|Behavioral|SpeakOut|"SpeakOut aims to increase social communication about IUDs and implants between adolescent IUD and implant users and their peers. SpeakOut has four components:
~Coaching session. Research staff will deliver a script to encourage recipients to share information about their contraceptive method with peers.
~Printed materials for recipients to keep and/or share with friends.
~Websites with information and resources. Staff will refer recipients to a website, either SpeakOutIUD.org or SpeakOutImplant.org, which contain information about their method.
~Text messages with information about recipients' method and about how to share their experience. Recipients will be given the opportunity to sign up for text messages that will be sent for 8 weeks following receipt of SpeakOut in clinic."
16012729|NCT02791971|Behavioral|Alcohol Control Intervention|The active comparator intervention is an alcohol assessment and education intervention using an SBIRT (Screening, Brief Intervention, and Referral to Treatment) framework. SBIRT is an evidence-based practice model aimed at preventing problematic use and identifying potential abuse and dependency issues. Research staff will ask two screening questions developed by the National Institute on Alcohol Abuse and Alcoholism (NIAAA) and the American Academy of Pediatrics to screen for adolescents potentially at risk. Using a script based on tenets of motivational interviewing to assess alcohol related consequences, the research staff will guide teens in identifying personally relevant motivators for healthier behaviors, assess readiness to change, and offer educational materials and referrals.
16012730|NCT02791958|Drug|Cardiovascular Fixed Dose Combination Pill AAR|A once daily oral dose of the Cardiovascular Fixed Dose Combination Pill AAR (acetylsalicylic acid 100 mg, atorvastatin 40 mg and ramipril 10 mg) for 4 weeks.
16012731|NCT02791958|Drug|Atorvastatin 40 mg|A once daily oral dose of atorvastatin 40 mg (Lipitor®) for 4 weeks
16012732|NCT02791958|Drug|Ramipril 10 mg|A once daily oral dose of ramipril 10 mg (Altace®) for 4 weeks
16012733|NCT02791945|Behavioral|Medical Management Counseling|Brief alcohol counseling
16012734|NCT02791945|Drug|N-acetylcysteine|Experimental supplement
16012735|NCT02791945|Drug|Placebo|Placebo comparator
16012736|NCT02791932|Behavioral|Exercise|See description above.
16012737|NCT02791919|Drug|Cytarabine|Given IV or IT
16012738|NCT02791919|Biological|Filgrastim|Given IV or SC
16012739|NCT02791919|Drug|Fludarabine Phosphate|Given IV
16012740|NCT02791919|Other|Laboratory Biomarker Analysis|Correlative studies
16012741|NCT02791919|Other|Pharmacological Study|Correlative studies
16012742|NCT02791919|Drug|WEE1 Inhibitor AZD1775|Given PO
16012743|NCT02791906|Drug|ISMN|
16012744|NCT02791906|Dietary Supplement|Vitamin C|
16012745|NCT02791893|Device|VNS device|Hand held device to use for self administration of vagus nerve stimulation.
16012746|NCT02791893|Device|Inactive device|Hand held device to use for self administration of simulated vagus nerve stimulation.
16012747|NCT02791880|Procedure|Transcatheter Aortic Valve Replacement|The investigators will collect blood and urine samples from patients with aortic stenosis who are undergoing transcatheter aortic valve replacement.
16012748|NCT02791867|Drug|AphoelineBrake|The study is proposed as a placebo controlled randomized controlled trial with an intervention (AphoelineBrake) in addition to their standard treatment in comparison to a standard treatment control arm receiving an identical placebo. Prior to the commencement of any study procedures, participants will document informed consent and acknowledgement of privacy rights. Participants will be seen for initial consenting procedures, initial study procedures, and follow-up procedures at the Dasman Diabetes Institute clinic.Scheduled study visits will occur at Day 0, Day 7, Months: 1, 3, 6, 9, and 12 months in accordance with standards of medical care.
16012749|NCT02791841|Behavioral|Rhythmic Reading Training|RRT is a child-friendly computerized reading training program designed for Italian students with DD aged 8-14 yrs. The main feature of this intervention is the integration of a traditional remediation approach (sublexical treatment) with rhythm processing. Therefore, all reading exercises are characterized by a rhythmic accompaniment with gradually increasing speed.
16012750|NCT02791841|Behavioral|Visual Hemispheric-Specific Stimulation + Action Video Games|"This training combines Visual Hemisphere-Specific Stimulation (VHSS) according to Bakker's Balance Model, and Action Video-Games (AVG). Hemispheric-specific stimulation is carried out by tachistoscopic presentation of words to a visual hemifield in order to selectively stimulate right-hemisphere perceptual analysis or left-hemisphere linguistic anticipation. A computerized program is used, in which the word is flashed and presented for less than 350 ms only if the child clicks on the mouse at the exact moment a dot is crossing a central target (control of eye position and fixation).
~AVG training involves dyslexic participants in a video-game training, specifically aimed at improving visuo-spatial attentional abilities. A commercial WiiTM video game from UbisoftTM (suitable for children age 7 and older by the Pan European Game Information) called 'Rayman Raving Rabbids' is used."
16012907|NCT02790632|Drug|EG-1962 (nimodipine microparticles)|Single intraventricular administration of EG-1962 via EVD and placebo capsules or tablets administered for up to 21 days
16012751|NCT02791841|Behavioral|Action Video Games|AVG training involves dyslexic participants in a video-game training, specifically aimed at improving visuo-spatial attentional abilities. A commercial WiiTM video game from UbisoftTM (suitable for children age 7 and older by the Pan European Game Information) called 'Rayman Raving Rabbids' is used.
16012752|NCT02791815|Drug|Midazolam|Single oral dose of 7.5 mg midazolam (tablet)
16012753|NCT02791815|Drug|Selexipag|Oral administration of selexipag (200 µg film-coated tablet) for 12 consecutive days (with a titration scheme from 400 to 1600 μg b.i.d. )
16012754|NCT02791789|Other|Autism Spectrum Disorder|Training to the serious game sematic, clinical exam, speech and language therapy and neuropsychological evaluations
16012755|NCT02791776|Other|Scoliosis|"self-administered questionnaire (SRS 30) to assess the state of health and disability of patients.
~Collection of patient's radiographic and clinical parameters"
16012756|NCT02791763|Drug|1 to 4 mg tablets of GSK1278863|7.0 millimeters (mm) round, standard biconvex, white film coated tablets containing 1 mg, 2 mg, or 4 mg of GSK1278863 as active ingredient, to be orally administered once daily.
16012757|NCT02791763|Drug|6 mg GSK1278863 tablet|9.0 mm round, standard biconvex, white film coated tablets containing 6 mg of GSK1278863 as active ingredient, to be orally administered once daily.
16012758|NCT02791763|Drug|Epoetin beta pegol|An injectable formulation containing 25 micrograms µg, 50 µg, 75 µg, 100 µg, 150 µg, 200 µg, or 250 µg of epoetin beta pegol per syringe (0.3 mL), supplied as a glass syringe prefilled with epoetin beta pegol solution (clear colorless to pale yellow). Epoetin beta pegol will be subcutaneously administered once every 2 or 4 weeks.
16012759|NCT02791750|Other|questionnary of quality of life|
16012760|NCT02791737|Behavioral|Exercise Intervention|Complete individualized exercise program
16012761|NCT02791737|Other|Laboratory Biomarker Analysis|Correlative studies
16012762|NCT02791737|Procedure|Physical Therapy|Complete individualized exercise program
16012763|NCT02791737|Other|Quality-of-Life Assessment|Ancillary studies
16012764|NCT02791737|Other|Questionnaire Administration|Ancillary studies
16012765|NCT02791724|Behavioral|Desiconnect|Desiconnect is an Internet intervention for persons with epilepsy and elevated depression. Content is continuously adapted to patients' concerns and needs. Techniques to overcome depression (e.g., cognitive restructuring, behavioral activation) and to cope with anxiety symptoms (e.g., exposure, role of avoidance, mindfulness exercises) are conveyed in interactive sequences that are accompanied by audio recordings, illustrations, and worksheets. Topics covered also include coping with epilepsy symptoms, identifying and coping with seizure auras and triggers, and the role of nutrition and exercise. Patients are also prompted to regularly complete brief symptom severity self-monitoring questionnaires. Optional daily text messages with motivational content accompany the program. The program can be accessed for 180 days after registration.
16012766|NCT02791724|Other|CAU|Care as Usual
16012767|NCT02791711|Other|High Flow Nasal Cannula|Evaluation of the use of High Flow Nasal Cannula by biological markers, questionary of quality of use of HFNC by the physician, questionary of evaluation of adverse events with HFNC
16012768|NCT02791685|Behavioral|MULTIFIT Cardiac Rehabilitation|MULTIFIT is a cardiac rehabilitation program delivered by the Movn smartphone application that will provide risk factor modification, prescribed exercises, education and counseling. The application will track activity using a built-in accelerometer or through connected devices such as a Fitbit for daily physical activity and management. Weight and blood pressure (BP) will be tracked by manual input or through wireless scales and BP monitors. The program will last for 12 weeks.
16012769|NCT02791685|Behavioral|Movn Pulmonary Rehabilitation|Movn pulmonary rehabilitation is a program delivered by the Movn smartphone application that includes targeted educational content and prescribed exercises with mild resistance training in addition to walking and other cardiovascular exercises. The application will track activity using a built-in accelerometer or through connected devices such as a Fitbit for daily physical activity and management. Weight and blood pressure (BP) will be tracked by manual input or through wireless scales and BP monitors. The program will last for 12 weeks.
16012770|NCT02791685|Behavioral|Standard of Care Cardiac Rehabilitation|Standard cardiac rehabilitation involves a facility's standard rehabilitation practices. Participants will be seen at baseline and during a 12 and 24 week follow-up visit.
16012771|NCT02791672|Behavioral|Discharge within 24 hours|If both the physician and patient have no concerns within 24 hours of a Latissimus Dorsi Flap breast reconstruction the patient will be discharged home and enrolled in the cohort group.
16012772|NCT02791659|Radiation|Automatic beam adjustment function|The fluoroscopy system has an automatic beam adjustment function to maintain a good quality of image output.
16012773|NCT02791646|Behavioral|Pain Coping Skills Training Full|Pain Coping Skills Training Full(PCST-Full) will consist of a 5-session intervention delivered to participants at the medical center by their therapist.
16012774|NCT02791646|Behavioral|Pain Coping Skills Brief|Pain coping skills training brief (PCST-Brief) will consist of a 60 minute, in-person session followed by 4-weeks of daily text messaging
16012775|NCT02791633|Other|Questionnaire|Quality of recovery and quality of recovery follow up questionnaires
16012776|NCT02791620|Device|a nanofractional radiofrequency device|A nanofractional radiofrequency device. noninvasive fractional radiofrequency device that provides ability to control and adjust the ratio of ablation and coagulation effect. Venus Viva, licensed by Health Canada, is cleared by the FDA for ablation and resurfacing dermatological procedures.
16012777|NCT02791594|Drug|Pembrolizumab|
16012778|NCT02791581|Diagnostic Test|Cardiac MRI|"Breast Cancer Patients Cardiac MRIs will be performed baseline, 3 months (for cancer patients only), and 24 months.
~Non-Cancer Controls Cardiac MRIs will be performed baseline and 24 months."
16012779|NCT02791568|Procedure|Ultrasound Scan|The research exam is expected to take 30 minutes for blood flow assessments
16012780|NCT02791568|Procedure|MRI Scan|MR imaging will take approximately 30 minutes.
16012825|NCT02791204|Device|SPECT/CT imaging|Subjects will undergo resting perfusion imaging of the feet using two separate SPECT/CT systems. Subjects will be injected with a low dose radioisotope. In addition to heated venous blood sampling, arterial blood will be continuously sampled from the radial artery for calculation of a blood input function and K1 values for foot angiosomes.
16012826|NCT02791191|Drug|LY3202626|Administered orally
16012827|NCT02791191|Drug|Placebo|Administered orally
16013506|NCT02786108|Procedure|left gastric artery embolization|
16012781|NCT02791568|Drug|Ferumoxytol|A subset of subjects will complete MRI imaging with ferumoxytol as a contrast agent at the 24-28 week visit. A nurse will administer ferumoxytol in a hospital triage with pulse and blood pressure monitoring and fetal heart monitoring. The pharmacy will prepare the infusion and deliver to triage. Subjects will arrive at the obstetric triage unit for ferumoxytol injection three days prior to their scheduled ferumoxytol MRI study. In the triage, the nurse will obtain baseline vital signs and fetal heart rate. The IV Ferumoxytol infusion will be 30 minutes and atients will be monitored at 5 to 15-minute intervals. Three days after the ferumoxytol infusion, at 24-26 weeks gestation, subjects will have blood/urine collected, undergo a 30 minute ultrasound, a 30 minute MRI, an adverse event review, and medical record review. The MRI scanning procedure will be conducted at WIMR and will last approximately 30-60 minutes.
16012782|NCT02791529|Procedure|Electrocautery|Skin incision performed by electrocautery
16012783|NCT02791529|Procedure|Scalpel|Skin incision performed by scalpel
16012784|NCT02791516|Drug|Romosozumab|Administered by subcutaneous injection once a month (QM)
16012785|NCT02791516|Drug|Placebo|Administered by subcutaneous injections once a month
16012786|NCT02791503|Procedure|Irreversible electroporation (IRE)|IRE is based on permeabilization of the cell membrane through electrical pulses leading to apoptosis. Theoretically, IRE only affects viable tumor tissue, leaving surrounding vital structures relatively intact. It is therefore considered to cause less morbidity than thermal ablative strategies.
16012787|NCT02791503|Procedure|Stereotactic ablative radiotherapy (SABR)|Stereotactic ablative radiotherapy (SABR) is a form of external beam radiation that has important advantages over conventional radiotherapy such as a more precise and greater biological dose delivery and hence less toxicity and presumably better outcome.
16012788|NCT02791490|Drug|Sitagliptin|Oral tablet, 100 mg, once daily at approximately the same time each day
16012789|NCT02791490|Drug|Placebo|Oral tablet, once daily at approximately the same time each day
16012790|NCT02791490|Drug|Metformin IR|All participants will take Met-IR as background medication. Initially, they will take 1 x 500 mg tablet Met-IR b.i.d. (1000 mg/day). After randomization, all participants will be titrated to 2 x 500 mg tablets of Met-IR b.i.d. (2000 mg/day).
16012791|NCT02791477|Device|Attune FB PS knee arthroplasty|
16012792|NCT02791464|Behavioral|Transcendental Meditation program|a mental technique using a mantra or 'soothing sound' that refines the thought process enabling the mind to 'transcend' its own thinking process and experience a state of pure consciousness. Subjects practice this technique twice a day for 20 minutes sitting in chair with eyes closed.
16012793|NCT02791451|Device|telemonitoring|To predict exacerbation of COPD with wireless telemonitoring
16012794|NCT02791438|Drug|Azilsartan|Azilsartan granules and tablets
16012795|NCT02791438|Drug|Placebo|Placebo-matching azilsartan granules and tablets
16012796|NCT02791425|Device|Brain Computer Interface (BCI) device|A BCI system to facilitate communication in intubated patients. Patients use the device in the ICU for communication for 2 hours a day for 3 consecutive days.
16012797|NCT02791425|Other|Communication picture board|The patient then uses a communication picture board for 2 hours a day for 3 consecutive days on the same days that the BCI device is used for comparison.
16012798|NCT02791412|Procedure|percutaneous coronary intervention or coronary-artery bypass graft|
16012799|NCT02791399|Behavioral|ISOP Intervention with the Nurse Care Manager|A Nurse Care Manager (NCM) will maintain a registry of enrolled patients, track opioid medication-related events from the medical record, and provide decision support to Primary Care Providers for issues related to prescription opioid safety. The NCM will also meet individually with enrolled participants in the intervention group to discuss strategies for preventing/reducing opioid side effects, preventing diversion, and providing rationale for screening for prescription opioid misuse.
16012800|NCT02791373|Drug|Vinorelbine|Mobilisation Chemotherapy
16012801|NCT02791373|Drug|Gemcitabine|Mobilisation Chemotherapy
16012802|NCT02791360|Other|Brain MRI|
16012803|NCT02791347|Other|Nutrition Intervention|
16012804|NCT02791334|Drug|LY3300054|Administered IV
16012805|NCT02791334|Drug|Ramucirumab|Administered IV
16012806|NCT02791334|Drug|Abemaciclib|Administered orally
16012807|NCT02791334|Drug|Merestinib|Administered orally
16012808|NCT02791334|Drug|LY3321367|Administered IV
16012809|NCT02791321|Other|ADS severity|Evaluation of the ADS severity with the CARS scale
16012810|NCT02791321|Other|Adaptative and intellectual functioning|Evaluation with IQ and Vineland II scale
16012811|NCT02791321|Other|Psychiatric and somatic comorbidities|Evaluation with the Reiss, DSQIID and CIRS Scales
16012812|NCT02791308|Drug|Pimecrolimus Cream 1% (Valeant)|
16012813|NCT02791308|Drug|Vehicle cream|
16012814|NCT02791308|Drug|Pimecrolimus Cream, 1%|
16012815|NCT02791295|Other|Diet and physical activity program|A personalized intervention focused on improving diet and increasing physical activity will be implemented at-home with a monthly support by a registered dietician and physical activity educator during 6 months
16012816|NCT02791282|Other|Index test: functional dynamic contrast enhanced (DCE)-MRI|Index test: functional dynamic contrast enhanced (DCE)-MRI Reference test: Ventilation-perfusion (VQ) single-photon emission computed tomography (SPECT) Follow-up per patient: clinical assessment after 6-12 months
16012817|NCT02791269|Drug|Peginterferon alfa-2a|180 mcg SC injection QW for 48 weeks.
16012818|NCT02791256|Drug|Ribavirin|
16012819|NCT02791256|Drug|peginterferon alfa-2a|
16012820|NCT02791243|Drug|Finasteride 0.25%|Cutaneous solution of finasteride 0.25%
16012821|NCT02791243|Drug|Placebo for Finasteride 0.25%|vehicle cutaneous solution of P-3074
16012822|NCT02791243|Drug|Negative Control|0.9% aqueous NaCl
16012823|NCT02791230|Drug|Tafamidis|Soft gel capsules administered once a day for 60 months
16012824|NCT02791204|Device|SPECT/CT imaging following revascularization procedures|Subjects will undergo resting perfusion imaging of the feet using two separate SPECT/CT systems. Subjects will be injected with a low dose radioisotope. Heated venous blood sampling will be obtained.
16012828|NCT02791178|Procedure|Optical coherence tomography (OCT)|Special camera to study part of your heart that was affected
16012829|NCT02791178|Procedure|Index of microcirculatory resistance (IMR)|Special wire to study part of your heart that was affected
16012831|NCT02791139|Other|Cardiovascular Magnetic Resonance Imaging (MRI)|Cardiovascular MRI uses interaction of the magnetic properties of body tissues with strong magnetic fields to create heart images.
16012832|NCT02791139|Other|Echocardiography|To measure heart chamber size, heart function, blood vessel size and blood vessel function. These measurements will help us understand the type and severity of heart failure.
16012833|NCT02791139|Other|Tonometry|Tonometry is a noninvasive method to obtain arterial pressure waveform
16012834|NCT02791139|Other|Genetic Testing (Blood)|The blood will be stored for genetic tests and development of cell lines to study genetic risks for aging related diseases and cardiovascular disease.
16012835|NCT02791139|Other|Hand-Grip Strength Measurement|We will measure your hand grip strength using a standard hand dynamometer which is a portable meter that you will use your hands to press on.
16012836|NCT02791139|Other|Body Fat Mass Analysis|Body composition will be analysed by a body composition analyser machine onto which you will have to stand on.
16012837|NCT02791126|Other|Cardiovascular Magnetic Resonance|For the evaluation of left ventricular volumes, function and mass. This is also for the assessment of myocardial fibrosis based on delayed enhancement imaging technique.
16012838|NCT02791126|Other|Echocardiogram|For the assessment of diastolic and systolic function as well as valvular and cardiac function. Ventricular-arterial coupling will also be performed.
16012839|NCT02791113|Other|Fractional Flow Reserve (FFR) Measurement|FFR is defined as the distal pressure to coronary lesion divided by the proximal coronary pressure. FFR is measured through a standard diagnostic catheter during coronary angiogram. FFR is used to guide whether to perform angioplasty or stenting or not in patients with coronary stenosis.
16012840|NCT02791100|Behavioral|Promotion of chicken eggs|Community is provided with chickens and young children are to receive 2 eggs a day plus egg shell
16012841|NCT02791087|Other|Computed Tomography Angiography|The CTA is non-invasive and is used commonly for patients who have chest pain to assess the coronary artery disease, prior to the more invasive coronary angiogram.
16012842|NCT02791087|Other|Intra-operative graft flow rate measurement|This procedure involves the insertion of a Medistim Ultrasound Transit Time Flow Probe into the graft vessel to measure its flow rate. This technique is commonly used for evaluating graft opening during CABG surgery.
16012843|NCT02791074|Other|NTproBNP|To assess its level in the blood, as a marker of heart failure presence and severity.
16012844|NCT02791074|Other|Echocardiography|To measure heart chamber size, heart function, blood vessel size and blood vessel function. These measurements will help us understand the type and severity of heart failure.
16012845|NCT02791074|Other|Arterial tonometry|A noninvasive method to obtain arterial pressure waveform.
16012846|NCT02791061|Other|Cardiovascular Magnetic Resonance Imagine (MRI)|MRI uses interaction of the magnetic properties of body tissues with strong magnetic fields to create images.
16012847|NCT02791061|Other|Cardiopulmonary exercise testing (CPET)|Cardiopulmonary exercise testing (CPET) is non-invasive simultaneous measurement of the cardiovascular and respiratory system during exercise to assess a patient's exercise capacity.
16012848|NCT02791061|Other|Echocardiography|To measure heart chamber size, heart function, blood vessel size and blood vessel function. These measurements will help us understand the type and severity of heart failure.
16012849|NCT02791048|Behavioral|Music therapy|"Music therapy is a clinical intervention conducted by qualified therapists who use shared music-making and improvisation to engage and interact with the client (s) in order to work towards specific therapeutic objectives.
~This is the aim of sessions, rather than the teaching or utilising of any musical skills, and clients do not have to have any prior musical training or experience whatsoever in order to participate in and benefit from music therapy. The intervention is client-led and the therapist will guide the patient in a range of strategies and activities appropriate to the therapeutic aims in place. Sessions can be individual, or family members can also be involved if appropriate and desired."
16012850|NCT02791035|Drug|Oral administration of Ipragliflozin|
16012851|NCT02791022|Device|SPYDER ECG sensor|
16012852|NCT02791009|Other|Cardiovascular Magnetic Resonance Imaging (CMRI)|CMRI uses interaction of the magnetic properties of body tissues with strong magnetic fields to create images; for about 1 hour. Several sets of images are needed. No injection of drug or dye will be used for this procedure.
16012853|NCT02791009|Other|Electrocardiogram (ECG)|ECG is a non-invasive test used to detect any underlying heart conditions by measuring the electrical activity of the heart.
16012854|NCT02791009|Other|Blood Sample Collection|Blood will be drawn for circulating biomarkers, which are measurable indicators of the severity or presence of the heart failure condition.
16012855|NCT02791009|Other|Clinical Assessment|Check health status, blood pressure, heart rate, height and weight measured. In addition, subject will undergo a heart examination.
16012856|NCT02791009|Other|Cardiovascular Ultrasound (CVUS)|To measure heart chamber size, heart function, blood vessel size and blood vessel function. These measurements will help the investigators understand the type and severity of heart failure.
16012857|NCT02791009|Other|Cognitive Test|To relate the presence and severity of cognitive impairment (CI) with simultaneously acquired advanced cardiovascular imaging characteristics and circulating biomarkers of cardiovascular function, inflammation and coagulation.
16012858|NCT02790996|Drug|Vancomycin|Vancomycin is an antibiotic used to treat a number of bacterial infections.It is recommended intravenously as a treatment for complicated skin infections, bloodstream infections, endocarditis, bone and joint infections, and meningitis caused by methicillin-resistant S. aureus.
16012859|NCT02790970|Device|PReDicT Test|PReDicT Test, when completed 7-9 days after starting antidepressant treatment, is able to predict a patient's subsequent response to that antidepressant treatment 4-6 weeks later
16012860|NCT02790970|Other|Treatment as Usual|Patients treated by the clinician conventionally using signs and symptoms to determine treatment changes or medication changes.
16012861|NCT02790957|Drug|Plerixafor|Single injection of 0.24 mg/kg Plerixafor
16012862|NCT02790957|Drug|Placebo|Single injection of an equal volume of NaCl solution
16012863|NCT02790944|Genetic|Multi-gene Next Generation Sequencing Panel|Participants will have genetic testing
16012905|NCT02790645|Other|Group 1b.Telemedicine program|After a washout period of 3 months and the crossing, Group 1 begins with medical monitoring via telematics application (Emminens Conecta® System, Roche Diagnostics SL) (TM) (6 months).
16012864|NCT02790931|Other|Intervention Group|Patients will receive a physical therapy intervention in groups twice/wk, and using a software twice/ wk for 3 months, for foot and ankle strengthening, stretching and functional training. They must continue to exercise at home twice a week with the software supervision for one year.
16012865|NCT02790918|Other|6MWT|Each patient will also receive 6MWT at cardiovascular rehabilitation and preventive cardiology laboratory. Besides the distance covered in meters or converted measure (such as feet) over 6 minutes, a portable metabolic system is used to measure oxygen uptake during exercise (VO2 testing) for each patient.
16012866|NCT02790918|Other|Cardiovascular Magnetic Resonance Imaging (CMRI)|MRI uses interaction of the magnetic properties of body tissues with strong magnetic fields to create images; for about 1 hour. Several sets of images are needed. No injection of drug or dye will be used for this procedure.
16012867|NCT02790892|Behavioral|Art therapy - pre and post test measures|12 weeks of 90 minutes of art therapy with pre and post test measures to determine changes in social support and levels of diabetes distress
16012868|NCT02790879|Other|Transition pediatric - adult|
16012869|NCT02790866|Behavioral|LuCaS Decision Aid|Web-based Lung Cancer Screening Decision Aid
16012870|NCT02790866|Behavioral|NCI Website|NCI Website on Lung Cancer Screening
16012871|NCT02790853|Procedure|Biopsy|Undergo brush biopsy and incisional biopsy
16012872|NCT02790853|Procedure|Fluorescence Imaging|Undergo PS2.1/PS3 imaging
16012873|NCT02790853|Procedure|High-Resolution Microendoscopy|Undergo HRME imaging
16012874|NCT02790853|Drug|Proflavine Hemisulfate|Applied on mucosa
16012875|NCT02790840|Drug|Omeprazole|20 mg oral capsules administered once daily for 10 days
16012876|NCT02790840|Drug|Omeprazole|40 mg oral capsules administered twice daily for 10 days
16012877|NCT02790840|Drug|Gefapixant|Gefapixant oral tablets (15 mg administered as two 7.5 mg tablets) administered twice daily for 15 days
16012878|NCT02790840|Drug|Gefapixant|Gefapixant oral tablets (30 mg administered as four 7.5 mg tablets) administered twice daily for 15 days
16012879|NCT02790827|Behavioral|CETA|CETA first focuses on: 1) awareness of alcohol problems, violence, and the link between them; 2) gender norms. Skills taught include: changing drinking behaviors, coping with cravings, family dynamics that contribute and result from alcohol use, the role gender plays, and community norms around problem drinking, and cognitive/emotional/behavioral patterns connected with inter-personal violence. The intervention then addresses: 1) positive parenting, 2) positive family relationships, conflict management, and communication skills, 3) attitudes and beliefs about violence, 4) mental health problems and 5) reducing (further) traumatic experiences. The cognitive behavioral therapy (CBT) principles of CETA overlap with the CBT skills for alcohol reduction.
16012880|NCT02790827|Behavioral|Treatment as usual|The control condition is defined as 'treatment as usual'. In Zambia, there are no formal services or standard of care for alcohol use problems or domestic violence. There are, however, organizations (such as non-governmental organizations) operating in Lusaka that provide intermittent services for these types of problems. Some families receive informal counseling from parish priests or other leaders in their communities. In this study we are therefore defining these types of informal services as 'treatment-as-usual.' We will closely track the type, number, and degree of these kinds of services that all participants receive and access. Following the conclusion of the study, we will offer the CETA intervention to control families if it has been found to be safe and effective.
16012881|NCT02790814|Device|Moyo strap-on|Continous measurements
16012882|NCT02790814|Device|Hand-held fetoscope|Intermittent measurements
16012883|NCT02790801|Other|observation|observation
16012884|NCT02790788|Drug|Methylprednisolone; hydrocortisone|Methylprednisolone 40 mg during resuscitation and stress-dose hydrocortisone for postresuscitation shock
16012885|NCT02790788|Drug|Saline Placebo|Saline placebo during resuscitation and during the postresuscitation phase.
16012886|NCT02790775|Drug|Anti-VEGF in quadrant 1|
16012887|NCT02790775|Drug|Anti-VEGF in quadrant 2|
16012888|NCT02790775|Drug|Anti-VEGF in quadrant 3|
16012889|NCT02790775|Drug|Anti-VEGF in quadrant 4|
16012890|NCT02790762|Biological|Human umbilical cord mesenchymal stem cells|A single dose of 2×107 hUC-MSC will be implanted to patients by intravenous infusion, and repeated every week for four times.
16012891|NCT02790749|Procedure|Adjunctive hip arthroscopy to accompany PAO|This is the experimental group: those patients who undergo adjunctive hip arthroscopy in addition to periacetabular osteotomy (PAO).
16012892|NCT02790749|Procedure|PAO without adjunctive hip arthroscopy|This is the control group: those patients who undergo periacetabular osteotomy (PAO) alone, without adjunctive hip arthroscopy.
16012893|NCT02790736|Drug|propranolol|active treatment
16012894|NCT02790736|Drug|Placebo|inactive pill
16012896|NCT02790710|Drug|Propanolol|Active treatment
16012897|NCT02790710|Drug|Placebo|
16012898|NCT02790697|Other|Indirect calorimetry|Indirect calorimetry will be conducted using the new calorimeter and mixing chamber method using the mass spectrometer.
16012899|NCT02790684|Drug|DS-8500a|
16012900|NCT02790671|Drug|DS-8500a|DS-8500a 25mg tablet
16012901|NCT02790671|Drug|Itraconazole|200mg itraconazole
16012902|NCT02790658|Dietary Supplement|Intake of grumixama juice|In the morning of experimental day after 10 h fasting, the volunteers have been collect the first urine in the morning and it was collected the blood before the intake of grumixama juice, after they drink the juice (0 min), it was collected blood at the times: 15 min, 30 min, 60 min,120 min, 240 min and 24 h; and it was also collected urine at the period: 0 -1h, 1 - 2h, 2 - 4h, 4 - 6 h, 6 - 12 h, 12 - 14 h, the first urine in the morning in the second day (24 h). During the period in the first 4 h of experiment the volunteers only intake the juice.
16012903|NCT02790645|Other|Group 2a. Telemedicine program|CSII (Accu-Chek Spirit®) and medical monitoring via telematics application (Emminens Conecta® System, Roche Diagnostics SL) (TM) (6 months).
16012904|NCT02790645|Other|Group 1a. Control|Treatment with CSII (Accu-Chek Spirit®) and follow-face doctor visits (conventional treatment -SMC-) (6 months).
16012906|NCT02790645|Other|Group 2b. Control|After a washout period of 3 months and the crossing, Group 2 begins with face doctor visits (conventional treatment -SMC-) (6 months) .
16012908|NCT02790632|Drug|Enteral Nimodipine|Enteral Nimodipine capsules or tablets administered for up to 21 days and single intraventricular administration of saline via EVD
16012909|NCT02790619|Device|tDCS via Chattanooga Ionto Iontophoresis System-Phoresor|Small electrical current delivered non-invasively to the scalp. 1mA electrical current to Meditation and Active Stimulation 1 condition. 2mA to Meditation and Active 2 Stimulation condition.
16012910|NCT02790619|Device|Sham tDCS Chattanooga Ionto Iontophoresis System-Phoresor|Blinds participants to meditation condition by applying 30 seconds of real stimulation and then turning the device off.
16012911|NCT02790606|Device|Covera(TM) Vascular Covered Stent|Treatment of stenoses with primary percutaneous transluminal angioplasty (PTA) and placement of the Covera Vascular Covered Stent.
16012912|NCT02790593|Device|Juxta-Cures™|Juxta-CURES™ is an adjustable compression device, which may be used as a secondary dressing for the treatment of open venous stasis ulcers. It is an inelastic wrap around device with a Built-In-Pressure System™, which allows patients to easily and accurately apply pressure to their own leg and adjust it throughout the day.
16012913|NCT02790593|Device|Standard Compression|Compression bandaging
16012914|NCT02790593|Device|PicoPress®|Pressure monitoring to be done at time of bandage application and removal for both arms of the study.
16012915|NCT02790593|Device|Silhoutte® 3D wound imaging system|Photographic imaging system to measure wound surface area and depth. Picture to be taken at each appointment. This intervention is for both arms of the study.
16012916|NCT02790580|Drug|Dose-dense doxorubicin/cyclophosphamide + sunitinib|"Doxorubicin 60mg/m2 day 1, every 2 weeks x 4 cycles Cyclophosphamide 600mg/m2 day1, every 2 weeks x 4 cycles Subcutaneous pegfilgrastim 6mg, 24-36 hours after each cycle of doxorubicin/cyclophosphamide Oral sunitinib 12.5mg daily for 7 days prior to cycle 1 ddAC (days -7 to 0) Oral sunitinib 12.5mg daily for 5 days prior to cycle 2, 3, 4 ddAC (days 10-14 of preceding cycle)
~Lumpectomy or mastectomy with sentinel lymph node biopsy or axillary lymph node clearance as appropriate should be considered after completing four cycles of chemotherapy for curative intent in non-metastatic patients and for local control for patients with metastatic disease."
16012917|NCT02790580|Drug|Dose-dense doxorubicin/cyclophosphamide|"Doxorubicin 60mg/m2 day 1, every 2 weeks x 4 cycles Cyclophosphamide 600mg/m2 day1, every 2 weeks x 4 cycles Subcutaneous pegfilgrastim 6mg, 24-36 hours after each cycle of doxorubicin/cyclophosphamide
~Lumpectomy or mastectomy with sentinel lymph node biopsy or axillary lymph node clearance as appropriate should be considered after completing four cycles of chemotherapy for curative intent in non-metastatic patients and for local control for patients with metastatic disease."
16012918|NCT02790567|Other|HEP score|"The HEP score is a clinicobiological score evaluating the probability of the HIT diagnosis.
~The HEP score is based on the blood platelet count, the timing of the platelet decrease, the existence of clinical manifestations of HIT (thrombosis, haemorrhage, skin necrosis) and the existence of an other cause of thrombocytopenia."
16012919|NCT02790567|Other|4Ts score|The 4Ts score is a clinicobiological score evaluating the probability of the HIT diagnosis. The 4Ts score is based on the change in blood platelet count during heparin therapy, the timing of platelet decrease, the existence of a thrombosis, and the existence of an other cause of thrombocytopenia.
16012920|NCT02790567|Other|ID-PaGIA test|The ID-PaGIA test is a particle gel immunoassay that detects immunoglobulins (Ig) G, A and M specific to the heparin/PF4 complexes.
16012921|NCT02790567|Other|HIT-Ab(PF4-H) test|The HIT-Ab(PF4-H) test consist in the incubation of plasma samples with latex beads coated PF4/polyvinylsulfate complexes. After binding of the plasma antibodies a monoclonal antibody recognizing PF4/heparin complexes is added. In the presence of human anti-PF4/heparin antibodies, binding of the monoclonal antibody and subsequent agglutination of latex beads is inhibited. Inhibition of agglutination is quantified and reported in arbitrary units (U/ml). A value equal or higher than 1.0 u/ml may indicate the presence of HIT antibodies.
16012922|NCT02790554|Device|Moyo strap-on|Continous monitoring
16012923|NCT02790554|Device|Hand-held Doppler|Intermittent monitoring
16012924|NCT02790541|Device|Hyperbaric Oxygen Therapy|60 daily sessions, 90 minutes of 100% oxygen at pressure of 2 ATA each, five days a week for 3 months.
16012925|NCT02790528|Drug|Atorvastatin|20mg QD
16012926|NCT02790528|Drug|Placebo|Placebo drug will be administered.
16012927|NCT02790515|Drug|Anti-thymocyte globulin (rabbit)|Given intravenous (IV) prior to transplant on Days -14, -13, -12.
16012928|NCT02790515|Drug|Blinatumomab|Given by continuous IV infusion at least 2 weeks post-engraftment. Blinatumomab will be given only to patients with CD19+ malignancies.
16012929|NCT02790515|Drug|Cyclophosphamide|Given by IV infusion prior to transplant on Day -9.
16012930|NCT02790515|Drug|Fludarabine|Given IV prior to transplant on Days -8, -7, -6, -5, and -4.
16012931|NCT02790515|Drug|G-CSF|Given IV or subcutaneous (SQ) following transplant on Days 6 and 7.
16012932|NCT02790515|Drug|Melphalan|Given IV prior to transplant on Days -2 and -1.
16012933|NCT02790515|Drug|Mesna|Given IV prior to cyclophosphamide administration and at approximately 3, 6, and 9 hours after cyclophosphamide infusion.
16012934|NCT02790515|Drug|Rituximab|Given IV prior to transplant on Day -1.
16012935|NCT02790515|Drug|Tacrolimus|Given oral (PO) or IV beginning prior to transplant on Day -2. The dose will begin to taper at approximately day +60 after transplant in the absence of GVHD. Tacrolimus was used for the first 5 participants enrolled on study. Subsequent participants receive sirolimus.
16012936|NCT02790515|Drug|Thiotepa|Given IV prior to transplant on Day -3.
16012937|NCT02790515|Biological|HPC,A Infusion|Hematopoietic Progenitor Cell, Apheresis (HPC,A) infusion of TCRɑβ+ depleted cells on day of transplant (Day 0) and HPC,A infusion of CD45RA+ depleted cells on Day +1 following transplant.
16012938|NCT02790515|Device|CliniMACS|The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells.
16012939|NCT02790515|Drug|Sirolimus|Given orally (PO) starting Day 0. The dose will be tapered off over two weeks starting on Day +42 in the absence of GVHD.
16012940|NCT02790502|Device|Food Photography Application©|Group testing RFPM as method of recording plate waste
16012941|NCT02790489|Dietary Supplement|Valedia|
16013507|NCT02786108|Behavioral|healthy diet and exercise|
16012942|NCT02790476|Other|Letters|"The letters will be factual and nonjudgmental, signed by the County Medical Examiner, and would state that a patient they had treated with controlled substances died of an opioid poisoning. The letter will encourage judicious prescribing, and will provide information developed by an advisory group: how to identify and taper unsafe regimens (high dose, polypharmacy, or use of multiple prescribers); how to identify addiction and compassionately refer patients for medication-assisted treatment; and recommendations to avoid bad outcomes (e.g. do not fire your patient for signs of addiction.) The letter would also encourage use of the CURES system before prescribing, as well as co-prescribing of naloxone."
16012943|NCT02790463|Behavioral|Pharmacist-Led Intervention|Pharmacists will conduct outreach primarily via an automated telephone interactive voice recognition system and direct (telephone) contact
16012944|NCT02790450|Drug|Benzbromarone|1x200mg Benzbromarone will be applied after baseline measurements during right heart catheterization. The effects of the drug on the pulmonary hemodynamics will be assessed after 2 hours.
16012945|NCT02790437|Drug|IdeS|One dose of 0.25 mg/kg BW IdeS on study day 0. If negative crossmatch is not achieved, a second dose can be given within 2 days of the first infusion.
16012946|NCT02790437|Procedure|Kidney transplantation|Performed following IdeS treatment
16012947|NCT02790424|Device|Imaging devices|technological adjustment tests
16012948|NCT02790411|Device|Imaging devices|technological adjustment tests
16012949|NCT02790411|Device|New Non Invasive Devices|Tests with REX BIONICS Exoskeleton
16012950|NCT02790398|Behavioral|Transdiagnostic treatment protocol|Transdiagnostic treatment protocol for emotional disorders whose aims are to learn and practice adaptive ways to regulate emotions from a transdiagnostic perspective. The protocol contains the following components: present-focused emotional awareness, cognitive flexibility, emotional avoidance and emotion driven behaviors, interoceptive and situation-based emotion exposure, psychoeducation about emotions, motivational enhancement and relapse prevention. These components are organized in twelve modules.
16012951|NCT02790398|Behavioral|Transdiagnostic treatment protocol + PA regulation component|Transdiagnostic treatment protocol for emotional disorders + PA regulation components has the purpose of learning and practicing adaptive ways to regulate emotions from a transdiagnostic perspective. This protocol includes the same components but it also includes 4 additional modules focused specifically on the regulation of positive affectivity.
16012952|NCT02790385|Device|Negative Pressure Wound Therapy|
16012953|NCT02790385|Other|Standard Gauze Treatment|
16012954|NCT02790372|Other|Case conferencing|Intervention nursing homes carries out regularly case conferencing based on comprehensive geriatric assessments. Case conferencing is carried out each month for nursing home patients included in the study
16012955|NCT02790359|Other|Air|Group of patients who would receive air insufflation
16012956|NCT02790359|Other|Carbon dioxide|Group of patients who would receive carbon dioxide insufflation
16012957|NCT02790346|Procedure|arthrodesis talonavicular|
16012958|NCT02790346|Procedure|tendon gestures|
16012959|NCT02790333|Procedure|traditional reloads|Blue cartridge with3.0mm height staple was used for pancreatic stump
16012960|NCT02790333|Procedure|Tri-Staple reloads|Purple cartridge with2.0-2.5-3.0mm varied-height staples was used for pancreatic stump
16012961|NCT02790307|Device|The Geko|transcutaneous tibial nerve stimulation (stick on patch)
16012962|NCT02790294|Device|Magnetic Resonance Imaging|The routine spine MRI protocol will be utilized, which includes the following sequences: haste localizer, sagittal T1, T2, and short-T1 Inversion Recovery (STIR), axial T2 for lumbar spine or axial gradient echo for cervical and thoracic spine, axial T1, post contrast sagittal and axial T1. All scans will be obtained using a 1.5 Tesla magnet.
16012963|NCT02790281|Procedure|Blood sampling|Blood sample collected at a single visit
16012964|NCT02790268|Procedure|Lens Subluxation Surgery|Surgical Intervention to include Cionni Ring implantation and in-the-bag IOL implantation
16012965|NCT02790255|Other|Cold air|
16012966|NCT02790255|Other|Cold water|
16012967|NCT02790229|Other|anti-gravity treadmill (alter G®)|Patients in the experimental arm will be treated with manual lymphatic drainage, cryotherapy and a fixed protocol of training in an anti-gravity treadmill (alter G®). The protocol is designed parallel to standard physiotherapy with a frequency of two to three times a week with duration of about 20 minutes for six weeks.
16012968|NCT02790229|Other|standardized physiotherapy|Patients in the control arm will be treated with manual lymphatic drainage, cryotherapy and 20 minutes of physiotherapy two to three times a week for six weeks. Physiotherapy will be done according to a standardized protocol.
16012969|NCT02790216|Procedure|Brachytherapy|Biopsies will be obtained after intraoperative plan to rule out significant cancer outside a high risk planning target volume
16012970|NCT02790203|Drug|Celecoxib|NSAIDS
16012971|NCT02790203|Drug|Placebo|Placebo
16012972|NCT02790190|Other|Radiotherapy dose|
16012973|NCT02790177|Drug|Hyaluronic Acid|
16012974|NCT02790177|Drug|NORMAL SALINE|
16012975|NCT02790164|Drug|Esmeron|Neuromuscular Blockade
16012976|NCT02790164|Drug|Saline|Normal Saline
16012977|NCT02790151|Behavioral|Standard Therapy|Learning and practicing Memory strategies
16012978|NCT02790151|Behavioral|Experimental Intervention|Computerbased Working Memory Training in Combination with a Recollection Training
16012979|NCT02790138|Drug|Vedolizumab Placebo|Vedolizumab placebo-matching IV infusion
16012980|NCT02790138|Drug|Ciprofloxacin|Ciprofloxacin tablets
16012981|NCT02790138|Drug|Vedolizumab|Vedolizumab IV infusion
16012982|NCT02790125|Drug|BMS-986166|
16012983|NCT02790125|Drug|Placebo matching BMS-986166|
16012984|NCT02790112|Other|GnRHas|"Influence of early adiposity rebound, genetic polymorphisms and GnRHa treatment on long-term outcome of treated and untreated girls with idiopathic central precocious compared to a control group.
~puberty."
16012985|NCT02790099|Drug|Bupivacaine|Surgical rectus sheath block will be performed by injection of 40ml bupivacaine (2.5mg/ml) before closure of rectus sheath during the operation.
16012986|NCT02790099|Drug|Morphine|0.1mg preservative free morphine will be injected intrathecally by anaesthesiologist at the time of spinal anaesthesia.
16012987|NCT02790073|Drug|SNF472|SNF472 for calciphylaxis
16013021|NCT02789813|Drug|Valproic Acid|Once oral administration of 500mg before exposure therapy.
16012988|NCT02790047|Device|A non-re-breathing face mask with conical-PEP device|Participant will use a non-re-breathing face mask with conical-PEP device during an interval endurance spot marching exercise.
16012989|NCT02790047|Other|A home-base exercise program|"Duration of the program is 8 weeks A frequency of exercise session is 3 to 5 sessions per week A content of each exercise session includes
~Stretching exercise (shoulder, trunk and leg muscles) to warm up for 5 to 10 minutes
~Interval endurance exercise using a spot marching movement for 30 to 40 minutes. In each phase of spot marching exercise, patients will perform the exercise from 0 to 3 or 4 score of 10 score of a modified dyspnea Borg scale, they will record exercise the exercise duration time. Then, they will be required to rest until a modified dyspnea Borg scale < 1 score. Next, they will perform the next interval of spot marching exercise with the same protocol.
~Stretching exercise (shoulder, trunk and leg muscles) to cool down for 5 to 10 minutes"
16012990|NCT02790047|Other|Health education|"Health education include
~Knowledge of COPD disease
~Smoking status and smoking cessation
~Medication correctly
~Self dyspnea management
~Basic nutrition for COPD"
16012991|NCT02790047|Other|ฺBreathing strategies for self secretion clearance|"Using a modified active cycle breathing technique (mACBT) include
~Control breathing
~Pursed lip breathing (PLB)
~Slow inhale with sustain thoracic expansion for 3 sec and exhale with PLB technique
~Force expiratory technique (FET) with low to medium lung volume
~Huffing or coughing"
16012992|NCT02790047|Drug|The medication following the COPD GOLD guidelines (2015)|"Patients will receive medications following the COPD GOLD guidelines (2015). The medication names were listed below
~Bata 2 agonist (short acting); Salbutamol (oral or inhaler), Terbutaline (oral)
~Bata 2 agonist (long acting); Bambuterol (oral), Procaterol (oral), Salmeterol (inhaler), Formoterol (inhaler)
~Xanthine derivative (sustained release theophylline)
~Anticholinergic; Tiotropium(inhaler), Ipratropium bromide (inhaler)
~Corticosteroids; Beclomethasone (inhaler), Budesonide(inhaler), Fluticasone(inhaler)
~Combined anticholinergic+ Beta 2-agonist; Ipratropium+fenoterol (inhaler), Ipratropium+salbutamol (inhaler)
~Combined Beta 2-agonist+ corticosteroids; Formoterol+ Budesonide(inhaler), Salmeterol+ Fluticasone(inhaler)"
16012993|NCT02790034|Drug|Sarizotan|2 to 10 mg per day of Sarizotan followed by assessment of safety, tolerability and efficacy on reducing the respiratory symptoms in patients.
16012994|NCT02790034|Drug|Placebo|placebo BID followed by assessment of safety, tolerability and efficacy on reducing the respiratory symptoms in patients.
16012995|NCT02790021|Procedure|Lymphaticovenous anastomosis (LVA)|LVA is a minimally invasive procedure that can be performed under local anesthesia. Indocyanine green (ICG) lymphography is used to visualize the (obstructed) lymphatic vessels. When using the images as a guide, the lymphatic pathways and the sites for incisions for lymphaticovenous anastomoses are marked with a pen. The patient's limb is then prepared for surgery. Under a surgical microscope the lymphatic vessels are identified and viable lymphatic vessels are anastomosed to similarly sized adjacent recipient venules in the subdermal plane.
16012996|NCT02789995|Procedure|Human biological samples|Blood sample - Muscle biopsy - Bone marrow sample (mesenchymal stem cells)
16012997|NCT02789982|Drug|β-adrenergic blocker propranolol|
16012998|NCT02789982|Behavioral|Treatment as usual|
16012999|NCT02789969|Drug|Hydromorphone|Hydromorphone 15mcg/kg IV
16013000|NCT02789969|Drug|Fentanyl|Fentanyl 1.5mcg/kg IV
16013001|NCT02789956|Device|Internal vs. external cad cam co/cr framework|
16013002|NCT02789943|Procedure|Cardiac Bypass Surgery|elective cardiac bypass surgery during which a sample of right atrial appendage and/ or aortic button can be removed
16013003|NCT02789930|Other|"Device: Accuracy of a program and the anesthesia tape (Anästhesie-Lineal)"|Computer based comparison of the two devices based on collected patient data
16013004|NCT02789917|Other|Dual Therapy|Combination of Apixaban 5mg/dl (or in reduced dosing of 2.5 mg/d depending on age, renal function and body weight) in combination with Clopidogrel 75 mg/d for 6 months.
16013005|NCT02789917|Other|Triple Therapy|"HAS-BLED-Score <3:
~Combination of Phrenprocoumon (INR 2.0-2.5), Clopidogrel (75mg/d) and ASA (100 mg/d) for 6 months.
~HAS-BLED-Score ≥ 3:
~Combination of Phrenprocoumon (INR 2.0-2.5), Clopidogrel (75mg/d) and ASA (100 mg/d) for 1 month followed by Phrenprocoumon (INR 2.0-3.0) and Clopidogrel (75mg/d) for 5 months."
16013006|NCT02789904|Other|blood taking|Blood taking will be done for chest pain patients presenting with chest pain at 0, 1 and 2 hour
16013007|NCT02789891|Procedure|D2 lymphadenectomy including No. 14v|After exclusion of T4b, or distant metastasis case by diagnostic laparoscopy, Laparoscopic distal with D2 lymphadenectomy including No. 14v Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience
16013008|NCT02789891|Procedure|lymphadenectomy excluding No. 14v|After exclusion of T4b, or distant metastasis case by diagnostic laparoscopy, Laparoscopic distal gastrectomy with D2 lymphadenectomy excluding No. 14v Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience
16013009|NCT02789878|Drug|Goserelin|Androgen Deprivation Therapy
16013010|NCT02789878|Drug|Prednisone|Corticosteroid
16013011|NCT02789878|Drug|Abiraterone|CYP17 inhibitor
16013012|NCT02789878|Drug|Apalutamide|Androgen-receptor antagonist
16013013|NCT02789865|Drug|Ertapenem, Levofloxacin and Metronidazole|The patients will be treated with intravenous broad-spectrum antibiotics (Ertapenem 1g/d) for 3 days and oral antibiotics (Levofloxacin 500mg once daily and Metronidazole 500mg 3 times per day) for 7 days. If patients in the antibiotic group deteriorate during the hospital stay (suspicious perforation or any symptoms of peritonitis) patients will be operated.
16013014|NCT02789865|Procedure|Endoscopic retrograde appendicitis therapy (ERAT)|The procedures of ERAT will be performed as below：1.Cannulation of the appendiceal lumen. 2.Endoscopic retrograde appendicography (ERA). 3.Irrigation and appendicolith removal. 4.Stenting for drainage.
16013015|NCT02789865|Procedure|Appendectomy|The patients will receive laparoscopic appendectomy according to standard routines.
16013016|NCT02789852|Device|Orthosis|use orthosis
16013017|NCT02789839|Procedure|Blood test|Blood test of 30mL
16013018|NCT02789839|Procedure|Medullar test|Medullar test for 2-5mL and a smear
16013019|NCT02789826|Procedure|Laparoscopic gastrectomy|Patients allocated to the 'laparoscopic gastrectomy' arm will receive gastrectomy via laparoscopy.
16013020|NCT02789826|Procedure|Open gastrectomy|patients allocated to the 'Open gastrectomy' group will receive gastrectomy via laparotomy
16013557|NCT02785744|Other|Gaucher disease DNA mutation analysis|
16013023|NCT02789813|Behavioral|Fear reactivation|Fear reactivation before exposure therapy.
16013024|NCT02789813|Behavioral|No fear reactivation|No fear reactivation before exposure therapy.
16013025|NCT02789800|Behavioral|DIMAC02|Integrated Approach For Chronic Diseases (DIMAC02) is an integrated approach for chronic disease prevention and management services that aims to improve and coordinate different regional initiatives in 11 Family Medicine Groups(FMG) related to : Self-management, Case management, Patient-centred care for persons with multimorbidity, Motivational approach, Interprofessional collaboration. DIMAC 02 specific objectives are: 1) To make available, in FMG's, an interdisciplinary educational intervention for prevention and management of chronic diseases for patients with low and high risk for complication. 2) To Increase the flow of communications between FMG and hospital facilities to improve continuity of care.
16013026|NCT02789787|Procedure|Maxillary Protraction|"Maxillary protraction is an alternative non-surgical approach to correct the Cl III malocclusion. At ages 11- 14, the maxillary sutures have not fused and can be mobilized by alternating weekly expansion and constriction with a rapid palatal expander (RPE), thereby allowing the maxilla to be protracted in order to correct the underbite. This treatment is offered to the patients, age 11-14, who have the Cl III malocclusion with or without cleft lip and palate."
16013027|NCT02789787|Procedure|Orthognathic Surgery|The orthognathic surgery is the current standard of care for treating the Cl III malocclusion after pubertal growth. This treatment is offered to the patients, after pubertal growth, who have the Cl III malocclusion with or without cleft lip and palate.
16013028|NCT02789774|Procedure|Posterior fusion C1-C2|Posterior access and screws in C1 (atlas) and C2 (axis) and fusion with addition of iliac crest bone graft. No postoperative collar.
16013029|NCT02789774|Procedure|Rigid cervical collar|External immobilization of cervical spine in a rigid collar for 12 weeks.
16013030|NCT02789761|Dietary Supplement|High-flavanol milk choocolate|
16013031|NCT02789761|Dietary Supplement|Low-flavanol milk chocolate|
16013032|NCT02789748|Device|Kinesthetic stimulation|Activation of mechanoreceptors by vibration bursts
16013033|NCT02789735|Device|Active laser therapy|Laser therapy at predetermined sites
16013034|NCT02789735|Device|Sham laser therapy|Sham therapy at predetermined sites
16013035|NCT02789722|Other|Yerba Mate Extract|Yerba Mate extract capsules 750 mg
16013036|NCT02789722|Other|Placebo|Take 3 capsules, 3 times daily for 28 days.
16013037|NCT02789709|Procedure|Surgery|Segmental resection for colon cancer and anterior resection in patients with rectal cancer
16013038|NCT02789696|Other|Diagnosis of acromegaly|Biological analysis of IGF-1
16013039|NCT02789683|Other|Fine emulsion|Emulsion is made up of distilled water, olive oil and emulsifier. Emulsion will be flavored, sweetened (sucralose) and served in a portion of 300ml and approximately 3 slices of white bread (50g of available carbohydrate). Additional glass of plain water will be provided with every treatment.
16013040|NCT02789683|Other|Coarse emulsion|Emulsion is made up of distilled water, olive oil and emulsifier. Emulsion will be flavored, sweetened (sucralose) and served in a portion of 300ml and approximately 3 slices of white bread (50g of available carbohydrate). Additional glass of plain water will be provided with every treatment.
16013041|NCT02789683|Other|Control|Beverage is made up of distilled water and olive oil. Beverage will be flavored, sweetened (sucralose) and served in a portion of 300ml and approximately 3 slices of white bread (50g of available carbohydrate). Additional glass of plain water will be provided with every treatment.
16013042|NCT02789670|Other|Blood sample collection|Peripheral blood will be collected in patients at the different time of the study to analyze phenotypic and functional properties of B cells in MS patients and control group
16013043|NCT02789657|Drug|paclitaxel|80 mg/m2 (or nab-paclitaxel 80-100 mg/m2) weekly
16013044|NCT02789657|Drug|Trastuzumab|Either every 3 weeks (8 mg/kg cycle 1 then 6 mg/kg cycles 2-4) or weekly (4 mg/kg week 1 then 2 mg/kg weeks 2-12)
16013045|NCT02789657|Drug|Pertuzumab|every 3 weeks (840 mg cycle 1 then 420 mg cycles 2-4) or weeks 1 and 2 cycle 1 (420 mg each dose) during the first 3-6 weeks of treatment, then 420 mg day 1 of cycles 2-4.
16013046|NCT02789657|Drug|carboplatin|AUC 2 administered weekly with no planned treatment breaks
16013047|NCT02789657|Procedure|Breast surgery|breast conserving or mastectomy
16013048|NCT02789657|Drug|AC|"doxorubicin and cyclophosphamide (AC) every 2 or 3 weeks for 4 cycles
~Dose-dense AC: Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 IV day 1 every 2 weeks x 4 cycles
~Standard AC: Doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 IV day 1 r every 3 weeks x 4 cycles"
16013049|NCT02789644|Drug|Ursodeoxycholic Acid|Day 1: Ursodeoxycholic acid 400mg or 800mg qd Day 2 to 15: Ursodeoxycholic acid 200mg bid
16013050|NCT02789631|Other|assessment|
16013051|NCT02789618|Other|A01|Subjects will brush their teeth twice a day using their assigned toothpaste for 56 days. The gel will be applied in the evening of three consecutive days during the study time period
16013052|NCT02789618|Other|B99|Subjects will brush their teeth twice a day using their assigned toothpaste for 56 days. The bonding agent will be professional applied immediately prior to the clinical assessments.
16013053|NCT02789618|Other|M89|Subjects will brush their teeth twice a day using their assigned toothpaste for 56 days.
16013054|NCT02789605|Drug|Bacilor|Patient receiving Lactobacillus rhamnosus Lcr35®, orally taken, 4 times a day, during 3 months. Then all patients will be then followed up for 3 additional months without treatment.
16013055|NCT02789605|Drug|Placebo|Patients of group B will took the placebo similarly at the Lactobacillus rhamnosus Lcr35® orally . All patients will be then followed up for 3 additional months without treatment.
16013056|NCT02789592|Drug|Melatonin PR|For experimental treatment of RBD
16013057|NCT02789592|Drug|Clonazepam|For experimental treatment of RBD
16013058|NCT02789592|Drug|Melatonin PR placebo|Placebo pill manufactured to mask melatonin PR 2mg tablet
16013059|NCT02789592|Drug|Clonazepam placebo|Placebo pill manufactured to mask clonazepam 0.5mg tablet
16013060|NCT02789579|Drug|levofloxacin|There are 50 patients in the group,each patient receives levofloxacin 0.5g, qd, po 7 days before Minimally invasive upper tract lithotomy.All patients in all groups, 30 minutes before surgery, are given preventive medication cefuroxime 1.5g ivgtt, and continue using 1.5g q12h ivgtt until postoperative 48 hours.
16013094|NCT02789332|Drug|PwCb|paclitaxel 80 mg/m² iv weekly in combination with carboplatin AUC 2 iv weekly for 12 weeks (PwCb) (37 patients)
16013061|NCT02789579|Drug|Nitrofurantoin|There are 50 patients in the group,each patient receives nitrofurantoin 0.1g, qd, po 7 days before Minimally invasive upper tract lithotomy.All patients in all groups, 30 minutes before surgery, are given preventive medication cefuroxime 1.5g ivgtt, and continue using 1.5g q12h ivgtt until postoperative 48 hours.
16013062|NCT02789579|Drug|cefuroxime|There are 150 patients in the group, 30 minutes before surgery, each patient is given preventive medication cefuroxime 1.5g ivgtt, and continue using 1.5g q12h ivgtt until postoperative 48 hours.
16013063|NCT02789566|Drug|Primaquine|Primaquine 30 mg taken after meal in the morning.
16013064|NCT02789553|Other|First starch meal then meal with glucose syrup|Before bypass surgery, patients will take randomized meal. One day a starch meal and another day a glucose syrup meal. 3 months after surgery, they will take these 2 randomized meal again, one day the first one, and the day after the other one.
16013065|NCT02789553|Other|First meal with glucose syrup then starch meal|Before bypass surgery, patients will take randomized meal. One day a meal with glucose syrup and another day a starch meal. 3 months after surgery, they will take these 2 randomized meal again, one day the first one, and the day after the other one.
16013066|NCT02789527|Drug|Phenotyping|finger-tip blood drop : enzymatic activities assessed by specific single point concentration ratios after oral intake of the Geneva micrococktail made of : CYP1A2: paraxanthine/caffeine CYP2B6: 4-hydroxybupropion/bupropion CYP2C9: 4-hydroxyflurbiprofen/flurbiprofen CYP2C19: 5-hydroxyomeprazole/omeprazole CYP2D6: dextrorphan/dextromethorphan CYP3A4: 1-hydroxymidazolam/midazolam
16013067|NCT02789527|Genetic|Genotyping|DNA sampling from a saliva sample
16013068|NCT02789501|Device|4% citrate lock solution regimen|(CitraFlow™ 4%, MedXL, Montreal, Canada) will be injected in each of the 2 lumens of the tunneled catheters after each dialysis session (2ml/lumen, 3x/week).
16013069|NCT02789501|Device|TauroLock lock solution regimen|After the first two dialysis sessions of the week (before the short intervals) 2 ml of TauroLock™-Hep500 containing 1% (cyclo)-taurolidine, 4% citrate and 500 IU/mL heparin will be injected into each of the two lumens of the tunneled catheter. After the third dialysis of the week, thus before the long interval, 2 ml of TauroLock™-U25.000 which contains 1% (cyclo)-taurolidine, 4% citrate and 25.000 IU urokinase will be applied into each lumen.
16013070|NCT02789488|Dietary Supplement|Fenugreek seeds extract 500 mg|Furocyst one caps BID
16013071|NCT02789475|Drug|Amlodipine|Amlodipine administration
16013072|NCT02789475|Drug|Rosuvastatin|Rosuvastatin administration
16013073|NCT02789462|Procedure|Laser-assisted percutaneous coronary interventions|Chart review and data collection of patients undergoing laser-assisted percutaneous coronary interventions
16013074|NCT02789449|Other|assessment of DLNO and DLCO|
16013075|NCT02789436|Drug|L. reuteri Prodentis® lozenges|Twice daily, for 28 days
16013076|NCT02789436|Other|Placebo lozenges|Twice daily, for 28 days
16013077|NCT02789423|Procedure|Direct Pulp Capping using Dycal and Biodentine|The operative procedure performed as follows: i)Administration of L.A and rubber dam isolation. ii)High-speed carious enamel removal. iii)Dentine mechanical curettage. iv)Manual final dentine curettage using a spoon excavator. v)Hemorrhage control by cotton pellet moistened with 2.5% sodium hypochlorite placed over the exposure for 1-2min. vi)The exposure site would then be dried with sterile cotton pellet.The operator shall apply the pulp capping agent(dycal/Biodentine)according to the manufacturer's instructions.And then another cover of glass ionomer is applied.This would be followed by permanent restoration.
16013078|NCT02789410|Drug|Morphine|Morphine is administered as part of spinal anesthesia for post-operative pain relief.
16013079|NCT02789410|Drug|Hydromorphone|Hydromorphone is administered as part of spinal anesthesia for post-operative pain relief.
16013080|NCT02789397|Drug|Rituximab (RTX) and Azathioprine (AZA)|Rituximab 375 mg/m2/dose IV over 4 hours first dose, IV over 2-3 hours each subsequent dose weekly for 4 weeks at enrollment and again at months 6 and 12 for the active comparator arm Rituximab (RTX) and Azathioprine (AZA).
16013081|NCT02789397|Drug|Placebos|IV placebo will be administered on the same schedule as Rituximab and oral placebo will be administered by mouth daily for 18 months.
16013082|NCT02789384|Other|Procedure/Surgery|"Procedure/Surgery: Newly obtained biopsy if applicable and Blood samples collection.
~For each patient:
~Frozen and paraffin embedded tumor material (archival or new biopsy) will be obtained for genetic profiling
~Blood samples will be obtained for genetic profiling and assessment of markers.
~The classification as CINSARC will be performed for each patient. Patients should be treated by neoadjuvant anthracycline-based chemotherapy. Chemotherapy regimen must contain at least doxorubicin (dose range: 60 -75 mg/m²) and ifosfamide (dose range: 2.5-3g/m²) to be delivered on a 21-days cycle basis up to 6 cycles prior surgery. After neoadjuvant chemotherapy completion, patients will be treated by surgery followed or not by radiotherapy.
~All patients should be managed according to the usual medical practices."
16013083|NCT02789371|Procedure|the first pass is made with 5ml suction technique|the first pass is made with 5ml suction technique, then modified wet suction technique / 5ml suction technique/ modified wet suction technique is operated successively.
16013084|NCT02789371|Procedure|the first pass is made with modified wet suction technique|the first pass is made with modified wet suction technique, then 5ml suction technique/ modified wet suction technique/ 5ml suction technique is operated successively.
16013085|NCT02789358|Other|Conventional cryotherapy dosage|Cryotherapy dosage: 180 seconds applications until block of the pulmonary vein plus 1 bonus freezing of 180 seconds
16013086|NCT02789358|Other|Experimental cryotherapy dosage|"cryotherapy dosage: applications time to block of the vein plus 60 seconds long until block of the vein plus 1 bonus freezing of 120 seconds"
16013087|NCT02789358|Device|Arctic Front Advance ST Cryoenergy Balloon Catheter|Electrical isolation of pulmonary veins with Arctic Front Advance cryoballoon
16013088|NCT02789358|Drug|Adenosine triphosphate|12 mg of adenosine triphosphate are administrated intravenously to test dormant conduction in pulmonary veins apparently disconnected
16013089|NCT02789358|Device|nECG platform Nuubo®|30 days electrocardiographic monitoring system to detect atrial fibrillation episodes after ablation
16013090|NCT02789345|Drug|Ramucirumab|Administered IV
16013091|NCT02789345|Drug|Necitumumab|Administered IV
16013092|NCT02789345|Drug|Osimertinib|Administered orally
16013093|NCT02789332|Drug|PwO|paclitaxel 80 mg/m² iv weekly in combination with olaparib tablets 100 mg twice daily for 12 weeks (PwO) (65 patients)
16072007|NCT02368327|Biological|Placebo|
16013095|NCT02789332|Drug|EC|both Arms followed by 4 cycles of epirubicin 90 mg/m² and cyclophosphamide 600 mg/m² (EC) either every 3 or every 2 weeks followed by surgery.
16013096|NCT02789332|Procedure|Surgery after neoadjuvant Therapy|In both study arms, treatment will be given until surgery, disease progression, unacceptable toxicity, or withdrawal of consent of the patients.
16013097|NCT02789332|Other|Stratification|Hormone-receptor status (HR+ vs HR-) Age < 40 years vs >= 40 years
16013098|NCT02789319|Device|Blood Glucose Meter Systems|
16013099|NCT02789306|Procedure|Epidemiological study on the incidence of peri-implantitis|Clinical and radiographic examination in the routine based protocol
16013100|NCT02789293|Device|EyeOP1 device|Ultrasound Ciliary Plasty (UCP procedure) using Focused Ultrasound
16013101|NCT02789280|Behavioral|Activities.|"Increasing activity level included a brief description of how activities affect mood. Participants were then asked to choose the activities they could use to improve their mood from an available list of helpful activities; users were also able to generate their own helpful activities. Participants were also presented with examples of unhelpful activities such as staying in bed and being isolated"
16013102|NCT02789280|Other|Wait list|will receive the behavioral activation condition after one week of completing baseline assessment.
16013103|NCT02789267|Other|Regular dietary support|Systematic and regular dietary support after radiotherapy
16013104|NCT02789254|Biological|FLYSYN|"Cohort 1:
~Patient 1-3: FLYSYN 0.5 mg/m² BSA* day 1
~Cohort 2:
~Patient 4-6: FLYSYN 0.5 mg/m² BSA day 1 FLYSYN 1.0 mg/m² BSA day 2
~Cohort 3:
~Patient 7-9: FLYSYN 0.5 mg/m² BSA day 1, FLYSYN 4.5 mg/m² BSA day 2
~Cohort 4:
~Patient 10-12 and 13-18: FLYSYN 0.5 mg/m² BSA day 1, FLYSYN 14.5 mg/m² BSA day 2
~Cohort 5:
~Patient 19-21: FLYSYN 0.5 mg/m² BSA day 1, FLYSYN 44.5 mg/m² BSA day 2
~Cohort 6:
~Patient 22-24 and 25-31: FLYSYN 0.5 mg/m² BSA day 1, FLYSYN 14.5 mg/m² BSA day 2, FLYSYN 15 mg/m² BSA day 15, FLYSYN 15 mg/m² BSA day 29
~* The maximum upper limit for calculation of antibody dose is fixed at a body surface of 2.0 m², even if the calculated body surface exceeds this. In this study DLT are defined as the following treatment-related adverse events or laboratory abnormalities, graded according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 4.03."
16013105|NCT02789241|Biological|Endotoxin|Reference Endotoxin is a purified LPS prepared from Escherichia coli O:113 (US Standard Reference Endotoxin); Clinical Center Reference Endotoxin (CCRE) Lot #94332B1 manufactured and vialed under GMP guidelines by List Biological Labs, Inc., 540 Division St., Campbell, CA 95008, for the Pharmacy Development Service, Clinical Center, National Institutes of Health, Bethesda, MD, USA. The material has been approved by the FDA (Food and Drug Administration) for 'Investigational Use Only'. This specific Lot from List Biological Labs specified for use in this study contains 1 mcg/vial.
16013106|NCT02789241|Other|Placebo|Normal saline will be administered as the control to evaluate the effects on the biomarkers over time and to compare the responses following LPS to those following the control injection of normal saline.
16013107|NCT02789228|Biological|Tumor associated antigen lymphocytes (TAA-CTL)|"This protocol is designed as a phase I dose-escalation study. In each treatment group (A and B), patients will be enrolled to one of the following TAA-T dose levels:
~Dose Level One: 1 x 107 cells/m2 Dose Level Two: 2 x 107 cells/m2 Dose Level Three: 4 x 107 cells/m2"
16013108|NCT02789215|Behavioral|Proposed Meal Changes for CACFP: Impact on Child Food Intake and Costs|
16013109|NCT02789202|Other|Silver diamine fluoride|Treatment of initial dental caries lesion in occlusal surface using the silver diamine fluoride.
16013110|NCT02789202|Other|Fluoride Varnish|Treatment of initial dental caries lesion in occlusal surface using the fluoride varnish
16013111|NCT02789189|Drug|nedaplatin and gemcitabine|
16013112|NCT02789176|Other|Surveys|Regarding development, epilepsy, and family impact
16013113|NCT02789176|Other|EEG|
16013114|NCT02789163|Device|Ultrasound|breast ultrasound; hand held and automated volume breast scanner
16013115|NCT02789150|Drug|Norepinephrine (Levophed)|Titrate norepinephrine to MAP 65-70
16013116|NCT02789150|Drug|Norepinephrine (Levophed)|Titrate norepinephrine to MAP 85 or greater
16013117|NCT02789124|Other|Carotid Doppler Measurement in response to passive leg raise|The investigators will measure Carotid Flow time in the semi-recumbent position, then lay the patient flat and do a passive leg raise. The investigators will then meausre Carotid Flow Time at 1 minute, 2 minutes, and 3 minutes. Patients who have 10 % increase in stroke volume on the Flotrac / Vigileo monitor will be considered fluid responders. The investigators will try to identify an optimum % increase of Carotid Flow Time that can predict fluid responsiveness.
16013118|NCT02789111|Drug|Alvimopan|Alviimopan 12 mg twice daily up to 15 doses
16013119|NCT02789111|Drug|Placebo|Placebo twice daily up to 15 doses
16013120|NCT02789098|Other|(15)-O water positron emission tomography and Biomarkers|Coronary endothelial function is assessed using (15)-O water positron emission tomography and cold pressor test . The response to the test is defined by the percentage increase myocardial blood flow . Assessment of fibrosis, inflammation an endothelial function is performed using biomarkers.
16013121|NCT02789085|Device|ULF TENS stimulation|
16013122|NCT02789072|Other|central aortic pressure (measured in mmHg).|"Blood pressure will only be measured during the 0g (microgravity) phase. Seven 5 ml blood sample will be drawn in the aircraft: before the first parabola (1) and after each block of 5 parabola (6).
~On ground after flight, a 9th 5 ml blood sample will be drawn and then the mobil-o-graph, the SOMNOtouch NIBP and the intravenous cannula will be removed."
16013123|NCT02789059|Other|muscle oxygenation|Subjects will be invited to perform an isokinetic effort of the knee extensors against an isokinetic dynamometer. During this effort, muscle oxygenation and oxygen consumption will be assessed with a near infrared spectroscopy device and a gas exchange measurement device. Patients affected by Becker muscular dystrophy and healthy controls will be invited to have a muscle biopsy of the vastus lateralis.
16013124|NCT02789046|Procedure|peripheral intravenous catheterization|success or failure intravenous placement on first attempt and factors associated with failed intravenous catheterization
16013125|NCT02789033|Drug|Chitosan|Chitosan chemically is a high-molecular-weight linear polycationic heteropolysaccharide comprising copolymers of 1,4-linked D-glucosamine and N-acetyl-D-glucosamine
16013126|NCT02789033|Drug|Isosorbide dinitrate|Isosorbide dinitrate (ISDN), is an organic nitrate, is a vasodilator with effects on both arteries and veins. The chemical name of ISDN is 1,4:3,6-dianhydro-D-glucitol 2,5-dinitrate
16013127|NCT02789033|Drug|Placebo|placebo
16013128|NCT02789020|Drug|Rasagiline|Rasagiline will be taken for one year at the dose of 1mg a day. and subjects will undergo functional and structural brain imaging to determine if rasagiline is slowing the progression of Parkinson's Disease in the brain.
16013129|NCT02789020|Other|Placebo|A placebo tablet will be taken for one year, once a day, and at the same dose of 1mg. subjects will undergo functional and structural brain imaging to be compared with the group taking the rasagiline intervention.
16013130|NCT02789020|Device|Magnetic Resonance Imaging|This test will be performed at baseline and one year.
16013131|NCT02789020|Device|functional Magnetic Resonance Imaging|This test will be performed at baseline and one year.
16013132|NCT02789020|Other|Physical Function Performance Test|This test will be performed at baseline and one year.
16013133|NCT02789007|Other|Assess the impact of parabolic flight|"MRI testing will be performed using a 3T MRI facility in Bordeaux close to Novespace (CHU Pellegrin).
~Spatial cognition will be assessed using a battery of in-house virtual paradigms General cognitive performance testing will include a wide range of cognitive functions, and particularly executive control using the Cognition Battery Mental status will be assessed on a tablet computer using a visual analogue scale Vigilant attention will be determined using the 3-min Psychomotor Vigilance Test (PVT) Blood samples (5 mL per collection) will be collected prior to neuroimaging by venepuncture"
16013134|NCT02788994|Device|Endovis BA2 nail|"The EBA2 intramedullary nailing system is designed for the treatment of lateral proximal femoral fractures, and consists of a standard or medium length nail implantable with the same set of instruments.
~The system has been designed to allow:
~stable fracture synthesis for fast rehabilitation and early mobilization
~an efficient set of instruments (only 11) for a swift, reproducible operating technique (just 7 surgical steps)"
16013135|NCT02788994|Device|Dynamic Hip Screw (DHS)|"The DHS is designed to provide strong and stable internal fixation of a variety of intertrochanteric, subtrochanteric and basilar neck fractures, with minimal soft tissue irritation.
~This Dynamic Hip Screw method is currently used and is a one off surgical fixation."
16013136|NCT02788981|Drug|Mifepristone|Patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle).
16013137|NCT02788981|Other|Placebo|Patients will receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle).
16013138|NCT02788981|Drug|Nab-Paclitaxel|Patients will either receive placebo and nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle) or patients will receive mifepristone 300 mg daily on the day prior to and day of each dose of nab-paclitaxel (100 mg/m2 on days 1, 8 and 15 of each 28 day cycle). Patients will receive mifepristone and nab-paclitaxel, or placebo and nab-paclitaxel. Not all three.
16013139|NCT02788968|Other|MRI|"Conventional reasoning tasks in both  with and without cognitive conflict and realized during an MRI"
16013140|NCT02788955|Behavioral|Dietary counselling|
16013141|NCT02788955|Other|Dietary Protein|
16013142|NCT02788942|Procedure|Removing from Epigastric port|The cholecystectomy material will be removed from epigastric port. This will be experimental group. Port site infection rates will be measured
16013143|NCT02788929|Device|Fitbit Charge HR|Patients randomized to the FitBit group will receive Fitbit Charge HR, a simple, user-friendly, wrist-worn, commercially available device which provides feedback on exercise goal adherence, in combination with the Fitbit mobile platform application.
16013144|NCT02788916|Other|No Intervention|
16013145|NCT02788903|Other|Weight Counseling|This is a natural experiment which will observe the impact of weight counseling by primary care physicians on patient outcomes.
16013146|NCT02788890|Procedure|Scaling without LA|The patient will undergo a supragingival scaling procedure without local anesthesia
16013147|NCT02788890|Procedure|Simple restoration under LA|The patient will undergo a simple dental restoration procedure under local anesthesia
16013148|NCT02788890|Procedure|Simple exodontia under LA|The patient will undergo a simple dental extraction procedure under local anesthesia
16013149|NCT02788877|Drug|aflibercept|Aflibercept 2mg is injected into the vitreous cavity through the pars plana using 30 gauge needle-attached syringe.
16013150|NCT02788864|Drug|Arterakine (DHA/piperaquine)|"Stage 1: Parasite Clearance
~Arterakine (DHA/piperaquine), one tablet contains 40 mg of dihydroartemisinine and 320 mg piperaquine. Weight based regimen: 7 mg/kg dihydroartemisinine; 55 mg/kg piperaquine phosphate) for 3 days
~Primaquine (One tablet contains 13.2mg primaquine disphosphate/7.5mg base. Weight based regimen: 0.25mg base/kg) for 14 days
~Stage 2: Forest trip
~• Arterakine (DHA/piperaquine), one tablet contains 40 mg of dihydroartemisinine and 320 mg piperaquine. Weight based regimen: 7 mg/kg dihydroartemisinine; 55 mg/kg piperaquine phosphate) for 3 days prior to forest visit (day -2, -1 and day 0 prior forest visit)"
16013151|NCT02788864|Drug|Placebo|"Stage 1: Parasite Clearance
~Arterakine (DHA/piperaquine), one tablet contains 40 mg of dihydroartemisinine and 320 mg piperaquine. Weight based regimen: 7 mg/kg dihydroartemisinine; 55 mg/kg piperaquine phosphate) for 3 days
~Primaquine (One tablet contains 13.2mg primaquine disphosphate/7.5mg base. Weight based regimen: 0.25mg base/kg) for 14 days
~Stage 2: Forest trip
~• Placebo (visually matched to Arterakine (DHA/piperaquine) for 3 days prior to forest visit (day -2, -1 and day 0 prior forest visit)"
16013152|NCT02788851|Drug|Methylphenidate compounds and /or Amphetamine compounds and/or Strattera or Guanfacine|Medication is titrated over a 4-week period with stepwise increments each week. Participants and their significant others will complete ADHD symptom scales at baseline and before each medication visit. Participants also complete a side effects scale at baseline and before each medication visit. The gradual increase will continue until there is no further improvement in symptoms and in the Clinical Global Improvement Scale or side effects are such that further increases are not indicated. Once the optimal dose is reached, the participant will remain on this dose for the remainder of the study. Additionally, once the optimal dose is reached participants will attend 8 weekly educational sessions about ADHD in adulthood.
16013153|NCT02788851|Behavioral|Aerobic Exercise|Participants will attend a structured aerobic exercise class twice a week for 8 weeks. Each class will last 60 minutes.
16013154|NCT02788825|Procedure|Targeted biopsies using Magnetic Resonance Imaging guiding|Prostate biopsies targeted by findings on MRI where findings are classified according to PI-RADS v2.
16013155|NCT02788812|Procedure|Open modified Lichtenstein repair|Open Lichtenstein Hernioplasty
16013156|NCT02788812|Procedure|Laparoscopic TAPP inguinal hernia repair|Laparoscopic TAPP Hernioplasty
16013398|NCT02786901|Drug|Loteprednol Etabonate Ophthalmic Gel dosed TID|Gel
16013157|NCT02788799|Other|Standard 12-Lead ECG|Conventional record of Standard 12-lead ECG in every patient with suspect of acute coronary syndrome.
16013158|NCT02788799|Other|Posterior ECG Leads|Recording posterior ECG leads (V7, V8 and V9) in addition to standard 12-lead ECG for identifying STEMI involving left cirumflex coronary artery.
16013159|NCT02788786|Drug|Chlorhexidine|non-alcoholic chlorhexidine gluconate antiseptic mouth rinse
16013160|NCT02788786|Drug|Cetylpyridinium chloride|non-alcoholic cetylpyridinium chloride antiseptic mouth rinse
16013161|NCT02788786|Drug|Salt and Water|salt and water mix oral rinse
16013162|NCT02788773|Drug|Durvalumab|
16013163|NCT02788773|Drug|Tremelimumab|
16013164|NCT02788760|Device|Cervical collar (Miami J collar - Össur)|The two groups of patients will similar in every way and will be treated with the same type of cervical collar - the only difference will be the length of treatment
16013165|NCT02788747|Drug|4 mg elamipretide|Subcutaneous injection of 4 mg elamipretide administered once daily for 28 consecutive days
16013166|NCT02788747|Drug|40 mg elamipretide|Subcutaneous injection of 40 mg elamipretide administered once daily for 28 consecutive days
16013167|NCT02788747|Drug|Placebo|Subcutaneous injection of placebo administered once daily for 28 consecutive days
16013168|NCT02788734|Other|Web-based survey|This study protocol consists of one anonymous survey. Each participant can complete only one survey. The survey will take approximately 25 minutes to complete. The survey is designed to identify items that best reflect the symptom severity and functional status in patients with CTS and CMT. A unique link to the survey will be included in an email invitation distributed to all adult CMT or HNPP patients self-registered in the RDCRN INC Contact Registry. Upon clicking the link, the participant will be directed to the IRB-approved online consent form. Upon providing consent, the participant will be directed to the online survey.
16013169|NCT02788721|Drug|GLPG2451 single dose|GLPG2451 oral suspension, single ascending doses, daily
16013170|NCT02788721|Drug|Placebo|Placebo, oral suspension, daily
16013171|NCT02788708|Drug|Lenvatinib Mesylate|Given PO
16013172|NCT02788708|Drug|Paclitaxel|Given IV
16013173|NCT02788708|Other|Pharmacological Study|Correlative studies
16013174|NCT02788682|Genetic|WT+ Diplotype|3 or 4 vitamin D binding protein major alleles
16013175|NCT02788656|Device|Implantable Hemodynamic Monitor|The CardioMEMS device is an implantable pulmonary artery pressure monitor that is FDA-approved for use in patients with symptomatic heart failure and previous heart failure hospitalization. Patients eligible for this study are those with an already implanted CardioMEMS device.
16013176|NCT02788656|Drug|Angiotensin-Converting Enzyme Inhibitor|Conventional, guideline-directed therapy for heart failure and reduced ejection fraction
16013177|NCT02788656|Drug|Angiotensin II Type 1 Receptor Blocker|Conventional, guideline-directed therapy for heart failure and reduced ejection fraction in ACE-inhibitor intolerant patients
16013178|NCT02788656|Drug|sacubitril/valsartan|Angiotensin-neprilysin inhibitor that is now FDA-approved and guideline-directed therapy for patients with symptomatic heart failure and reduced ejection fraction despite treatment with an ACE-inhibitor/Angiotensin-Receptor Blocker
16013179|NCT02788643|Biological|biological fluids (serum, bronchoalveolar lavage and pulmonary aspiration) and bronchial biopsies collection|
16013180|NCT02788630|Behavioral|Sleep hygiene counseling|The mothers of the eligible infants will be visited at home and will be invited to participate at the study. To those who sign the Consent Form (CF) a following visit will be scheduled to within 5 days. Between CF signature and the 5-day visit, the enrolled children will use an actigraph-device in the leg and the mothers will fill out a sleep diary registering the times of the day the child is asleep, awake, napping, and feeding. At the 5-day visit the child allocation in the trial (intervention or control group) will be uncovered and the sleep recommendations will be delivered to mothers in the intervention group. Phone calls on days 6 and 7 and a home visit on day 8 will be paid to support mothers for possible difficulties in implementing the recommendations.
16013181|NCT02788617|Device|Diafert|The Diafert output, the G-CSF concentration in FF, will be recorded but will not be used in patient management.
16013182|NCT02788604|Other|Summary of psychosocial risk factors|The treatment team will receive a psychosocial risk summary shortly following diagnosis based on parent report.
16013183|NCT02788604|Other|Control|The treatment team will NOT receive a psychosocial risk summary shortly following diagnosis based on parent report.
16013184|NCT02788591|Drug|Proton Pump Inhibitor (PPI) Therapy|Subject will take a proton pump inhibitor (PPI) of their choice (Omeprazole, Esomeprazole, Pantoprazole, or Lansoprazole) 2 times a day for 8 weeks.
16013185|NCT02788591|Drug|Sucralfate|Subject will take Sucralfate 4 times a day for 8 weeks.
16013186|NCT02788552|Drug|Thiamine Hydrochloride|Administered Intravenously in 100ml bag of normal saline (0.9%) infused over 30 mins.
16013187|NCT02788539|Behavioral|Our Whole Lives Website|OWL is a nine-session, web accessible, self-paced curriculum that has interactive components of self-monitoring and social support (online community).
16013188|NCT02788526|Procedure|Adjuvant TACE|1~2 cycles TACE were performed as adjuvant therapy after radical hepatectomy
16013189|NCT02788526|Procedure|Follow-up|Patients received just follow-up to monitor the recurrence of HCC
16013190|NCT02788513|Drug|BI 425809 dose 1|
16013191|NCT02788513|Drug|BI 425809 dose 2|
16013192|NCT02788513|Drug|BI 425809 dose 3|
16013193|NCT02788513|Drug|BI 425809 dose 4|
16013194|NCT02788513|Drug|Placebo|
16013195|NCT02788500|Other|Incidence of sports-related injuries and illnesses|The SRIIP-study is an epidemiological cohort study aimed to prospectively collect self-report data on sports-related injuries and illnesses incidence and risk exposure during training and competition for approximately one year among Swedish para-athletes.
16013196|NCT02788487|Device|Tongue retaining device|Tongue retaining device is used for 3 weeks
16013197|NCT02788487|Device|CPAP|CPAP is used for 3 weeks
16013198|NCT02788474|Drug|nintedanib|
16013199|NCT02788474|Drug|placebo|
16013200|NCT02788461|Radiation|Chemoradiotherapy|Patients will receive radiotherapy of 60Gy in 30 fractions (5x per week) with concurrent cisplatin and etoposide chemotherapy.
16013201|NCT02788461|Radiation|Chemoradiotherapy with Integrated Boost Dose|Patients will receive an RT integrated boost to tumor subvolumes (max boost dose of 85Gy) in 30 fractions (5x per week) with concurrent cisplatin and etoposide chemotherapy.
16013202|NCT02788448|Device|VIVASURE CLOSURE DEVICE|Large hole closure device
16013203|NCT02788435|Behavioral|Absolute Voice Rest|Patients will be instructed to not use their voice and minimize any voice-use activities such as coughing or throat-clearing for a period of 7 days following surgery.
16013204|NCT02788422|Other|Video discharge instructions|Online video containing information on how to manage symptoms of acute otitis media and when to return to a health care professional.
16013205|NCT02788422|Other|Standard of Care|One page paper handout containing information on how to manage symptoms of acute otitis media and when to return to a health care professional.
16013206|NCT02788409|Other|Not applicable for study|Provide external perspective on background second primary cancer incidence rates for REASSURE study.
16013207|NCT02788370|Device|a conical positive expiratory pressure device|The CPEP device will be connected to respiratory transducer for generating positive expiratory pressure with therapeutic rang (5 to 20 cm H2O).
16013208|NCT02788370|Other|Constant work load cycling test|"Participants will per form constant work load cycling test until symptom limit with 50 to 60 rpm. The termination criteria include
~sever breathlessness (>5 /10 score of modified Borg scale)
~leg fatigue (can not maintain speed between 50 to 60 rpm)
~Hear rate (HR) >80 % age-predicted maximum HR
~Exercise time up to 10 minutes
~Other symptom that stated by American thoracic Society(2002)"
16013209|NCT02788357|Drug|Atomoxetine|Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake.
16013210|NCT02788357|Drug|Placebo|Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake.
16013211|NCT02788344|Other|Daily practice care for patients with suspected of STEMI|N/A: Practice care evaluation in real-life setting
16013212|NCT02788331|Other|No intervention|
16013213|NCT02788318|Other|Brain samples|Collected in patients died
16013214|NCT02788318|Other|Skin samples|Collected in patients died
16013215|NCT02788305|Drug|Misoprostol|Misoprostol 25 micrograms every 6 hours will be given to obese and non obese groups
16013216|NCT02788292|Drug|Acetylcysteine|See arm description
16013217|NCT02788279|Drug|Atezolizumab (MPDL3280A), an Engineered Anti-PDL1 Antibody|Participants will receive atezolizumab IV at 840 mg on Day 1 and Day 15 in a 28-day cycle as a combination therapy or at 1200 mg on Day 1 in a 21-day cycle as a monotherapy until disease progression according to RECIST Version 1.1, unacceptable toxicity, death, participant's or physician decision to withdraw, or pregnancy, whichever occurs first.
16013218|NCT02788279|Drug|Cobimetinib|Participants will receive cobimetinib 60 mg orally on Days 1 to 21 in a 28-day cycle as a combination therapy until disease progression according to RECIST Version 1.1, unacceptable toxicity, death, participant's or physician decision to withdraw, or pregnancy, whichever occurs first.
16013219|NCT02788279|Drug|Regorafenib|Participants will receive regorafenib 160 mg orally on Days 1 to 21 in a 28-day cycle until disease progression according to RECIST Version 1.1, unacceptable toxicity, death, participant's or physician decision to withdraw, or pregnancy, whichever occurs first.
16013220|NCT02788266|Procedure|connective tissue graft+composite resin|treatment of gingival recession associated with cervical lesions with sub epithelial connective tissue graft plus composite resin
16013221|NCT02788266|Procedure|connective tissue graft+ glass ionomer|treatment of gingival recession associated with cervical lesions with sub epithelial connective tissue graft plus resin modified glass ionomer cement
16013222|NCT02788266|Procedure|connective tissue graft+giomer|treatment of gingival recession associated with cervical lesions with sub epithelial connective tissue graft plus giomer
16013223|NCT02788240|Drug|Peg GCSF|
16013224|NCT02788240|Biological|20% Albumin|
16013225|NCT02788240|Dietary Supplement|Nutrition|
16013226|NCT02788240|Other|Bowel wash|
16013227|NCT02788240|Drug|Terlipressin 1- 4mg,if indicated|
16013228|NCT02788240|Drug|Meropenem or Imepenem, if indicated|
16013229|NCT02788240|Drug|Placebo|
16013231|NCT02788201|Drug|75 approved agents|One or combination of agents: Abiraterone, Arsenic Trioxide, Asparaginase Escherichia coli source, Axitinib, Azacitidine, Bendamustine, Bleomycin, Bortezomib, Busulfan, Carboplatin, Carfilzomib, Carmustine, Chlorambucil, Cisplatin, Cladribine, Clofarabine, Crizotinib, Cytarabine, Dacarbazine, Dactinomycin, Dasatinib, Daunorubicin, Decitabine, Docetaxel, Doxorubicin, Epirubicin, Eribulin, Erlotinib, Estramustine, Etoposide, Exemestane, Floxuridine, Fludarabine, Fluorouracil, Gefitinib, Gemcitabine, Hydroxyurea, Idarubicin, Ifosfamide, Imatinib, Irinotecan, Ixabepilone, Lapatinib, Lomustine, Mechlor, Melphalan, Mercapto, Methotrexate, Mitomycin, Mitotane, Mitoxantrone, Nilotinib, Oxaliplatin, Paclitaxel, Pazopanib, Pentostatin, Romidepsin, Ruxolitinib, Sorafenib, Streptozocin, Sunitinib, Tamoxifen, Temsirolimus, Teniposide, Thioguanine, Thiotepa, Topotecan, Toremifene, Tretinoin, Vandetanib, Vemurafenib, Vinblastine, Vincristine, Vismodegib, and/or Vorinostat
16013232|NCT02788201|Other|COXEN|The CO eXpression ExtrapolatioN (COXEN) algorithm will be used to determine the next best therapy from among 75 Food and Drug Administration (FDA) approved agents (single agent or combination) in patients that have progressed on at least one chemotherapy regimen.
16013233|NCT02788188|Biological|SAB-301|SAB-301 is a purified human immune globulin G (hIgG) polyclonal antibody designed to specifically bind to the MERS-CoV spike (S) protein, a component of the virion membrane that is responsible for binding of the virus to the host cell. The hIgG is purified from the plasma of immunized transchromosomic (Tc) bovines that were immunized with a recombinant spike protein produced in insect cells. SAB-301 is purified hIgG in a sterile liquid formulated in 10 mM glutamic acid monosodium salt, 262 mM D-sorbitol, 0.05 mg/mL Tween 80, pH 5.5. The drug product will be administered intravenously and will be diluted in saline per the clinical protocol.
16013234|NCT02788188|Other|Normal (9%) Saline|Normal (0.9%) saline in approximately the same volume as each cohort in the experimental drug arm.
16013235|NCT02788175|Biological|Entyvio (Vedolizumab)|A humanized monoclonal antibody that specifically binds to the alpha4beta7 integrin with MAdCAM-1, which in turn inhibits the migration of T-lymphocytes across the endothelium into GALT
16013236|NCT02788162|Drug|Coppertone (BAY 987517)|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.(Formulation Number - X71-144)
16013237|NCT02788149|Device|Ultrasound Exam|Ultrasound of Neck will be used to assess the Lateral parapharyngeal wall thickness. Ultrasound of neck with Submental approach will be used to assess tongue base thickness, subcutaneous fat thickness, retropalatal diameter, retroglossal diameter and upper airway length during normal tidal expiration, forced inspiration and muller's maneuver
16013238|NCT02788149|Device|Polysomnography|"Full-night PSG will be performed in the sleep laboratory according to protocol of sleep medicine department after US assessment. Apnea will be defined as the absence of airflow ≥10 sec and hypopnea will be defined as >50% decrease in airflow ≥10 sec associated with reduced arterial oxygen saturation by 4%, or an arousal. These two parameters are collectively defined as apnea-hypopnea index (AHI). An arousal will be recorded if there is a 3-second or longer abrupt shift in electroencephalogram frequency to alpha or theta or above 16 Hz, following at least 10 seconds of sleep, and, if arising in rapid eye movement sleep, there should be a rise in electromyographic tone. An independent technician blinded to the US results will analyze the sleep studies.
~Episodes of AHI per hour will be used to diagnose and grade the severity of OSA:
~Non-OSA : < 5/hr mild OSA : 5- 14/hr moderate OSA :15-29/hr and severe OSA : ≥30/hr."
16013239|NCT02788136|Drug|human chorionic gonadotropin|At 08 AM of day 0, all subjects underwent to a single intramuscular injection of hCG of 5000 IU
16013240|NCT02788123|Drug|bismuth tripotassium dicitrate|oral
16013241|NCT02788123|Drug|pantoprazole|oral
16013242|NCT02788110|Other|Noninvasive neurally adjusted ventilatory assist (NIV NAVA)|Neurally adjusted ventilatory assist (NAVA) is a mode of ventilation that uses a functional naso/orogastric tube with embedded electrodes which detect diaphragmatic contractions (called the Edi signal). NAVA uses this Edi signal to synchronize ventilator support to the patient's own respiratory efforts and to support these efforts as needed.
16013243|NCT02788110|Other|Nasal intermittent positive pressure ventilation (NIPPV)|"Nasal intermittent positive pressure ventilation (NIPPV) or noninvasive pressure control ventilation (NIV PC) is a mode of ventilation delivering unsynchronized puffs of air or breaths to a baby through nasal cannulae."
16013244|NCT02788097|Procedure|Progesterone supplementation|artificial frozen embryo transfers
16013245|NCT02788071|Dietary Supplement|FMT capsules|25 capsules per day for 12 days
16013246|NCT02788071|Dietary Supplement|FMT placebo|25 capsules per day for 12 days
16013247|NCT02788058|Drug|EGFR-TKI|Gefitinib 250mg po qd or Erlotinib 150mg po qd or Icotinib 125mg po tid
16013248|NCT02788058|Radiation|Thoracic Hypofractionated Radiotherapy|40-45 Gy/5-15f
16013253|NCT02788032|Other|EnergieShake oral supplement|The participants will be given EnergieShake® powdered nutritional supplement twice daily during the study period in place of their usual ONS. Participants will take their usual ONS for 2 days followed by an 8 day intervention on EnergieShake®
16013254|NCT02788019|Drug|Ropivacaine|Ropivacaine is routinely used to perform localized blockade prior to surgery to improve management of postoperative pain.
16013255|NCT02788006|Drug|Regorafenib 160 mg|
16013256|NCT02787993|Behavioral|Cognitive Behavioral Mult-Symptom management(CBT)|Learn to manage distress, fatigue, and/or pain via Cognitive Behavioral Multi-Symptom Management(CBT). Four sessions will be conducted each session is approximately one hour.
16013257|NCT02787980|Biological|Additional taking blood|Additional blood collection of 1 ml during the biological workup usually done.
16013258|NCT02787967|Drug|CHF 1535 35/4µg NEXThaler®|4 (four) inhalations (total dose: BDP/FF 140/16 µg)
16013259|NCT02787967|Drug|free comb. beclomethasone DPI and formoterol DPI|2 (two) inhalations BDP 100 µg DPI + 4 (four) inhalations FF 6 µg DPI (total dose: BDP 200 µg + FF 24 µg
16013260|NCT02787954|Procedure|TACE|Procedure for giving chemotherapy directly to tumor cells.
16013261|NCT02787954|Procedure|Y-90|Using a combination of radiation and chemotherapy directly on the tumor cells to cause cell death.
16013262|NCT02787954|Procedure|MWA|Using heat to kill tumor cells.
16013263|NCT02787954|Procedure|IRE|Using energy to disrupt tumor cell activity, thereby causing cellular death.
16013264|NCT02787941|Behavioral|Pharmacist-delivered multifaceted intervention|"First counselling: A pharmacist performs a 30-minute in-person counselling within 1 week before discharge including: (1) assessment and giving advice on basic knowledge of acute coronary syndrome: definition, risk factors, possible cardiac events, and prevention; (2) assessment of past experiences of using medications, encouragement and tailored advice; (3) providing support with pill organiser and drug information leaflet; (4) teaching back and correcting misunderstanding.
~Second counselling: A pharmacist performs a 30-minute telephone counselling within 1 week after discharge including: (1) assessment of general and medication-related issues patients concerning; (2) encouragement and tailored advice; (3) teaching back and correcting misunderstanding."
16013265|NCT02787928|Drug|Intrathecal hydromorphone|Intrathecal hydromorphone will be administered in an up/down dosage fashion. A successful dose will be defined as a patient not requiring additional narcotic pain medication outside of the standard VCU order set, which includes PRN oxycodone 5 and 10 mg every 4 hours and a one time PRN 1 mg hydromorphone IV. Failure of a dose will be if patient requires additional narcotic pain medication outside of these parameters
16013266|NCT02787915|Biological|DC1-CTL|Autologous cytotoxic of T lymphocytes (CTL) were induced by type-1 polarized dendritic cells (DC1) loaded with MAGE-3/MAGE-4/survivin/ her2 /COX-2 CTL epitope peptides .
16013267|NCT02787902|Behavioral|Communication|Behavioral weight management program adapted for mother-daughter dyads with communication skills training
16013268|NCT02787902|Behavioral|Standard|Behavioral weight management program adapted for mother-daughter dyads without communication skills training
16013269|NCT02787889|Other|Uneven Protein intake pattern|Each participant will consume 15%/2-%/65% of total protein in breakfast, lunch, and dinner, respectively)] on net protein synthesis over 8 weeks.
16013270|NCT02787889|Other|Even Protein Intake Pattern|Each participant will consume 33% of total protein consumed each meal
16013271|NCT02787876|Drug|Pegteograstim|
16013272|NCT02787863|Biological|Prevenar-13|Conjugate 13 serotype pneumococcal vaccine
16013273|NCT02787863|Biological|Pneumo-23|Polysaccharide 23-valent pneumococcal vaccine.
16013274|NCT02787850|Device|CoolSculpting Treatment|The CoolSculpting device will be used to perform treatments.
16013275|NCT02787824|Drug|Iron Sucrose Supplement|
16013276|NCT02787811|Device|Intrauterine insemenation|Semen preparation processing hen intrauterine transfer after 24 hours of HCG triggering of ovulation
16013277|NCT02787798|Drug|valsartan/sacubitril 100 mg|Treatment with 100 mg tablets during 2 to 4 weeks
16013278|NCT02787798|Drug|valsartan/sacubitril 200 mg|Treatment with 200 mg tablets during 2 to 4 weeks
16013279|NCT02787798|Procedure|Microneurography|Microneurography recording of sympathetic nervous system activity in muscle destiny
16013280|NCT02787785|Device|Subcutaneous Implantable Cardioverter Defibrillator|The S-ICD is an entirely subcutaneous implantable cardioverter defibrillator.
16013281|NCT02787772|Procedure|Elective Hernia repair|abdominal wall hernia repair using onlay mesh.
16013282|NCT02787759|Other|Hands-Free Walking|Walking on a treadmill at 60-80% maximum heart rate without holding onto anything
16013283|NCT02787759|Other|Challenge Based plus Hands-Free'|Walking on a treadmill at 60-80% maximum heart rate without holding onto anything under 9 different challenging conditions
16013284|NCT02787746|Drug|Donepezil|Eligible patients is treated with Aricept® 10 mg/day for 20 weeks of study period. Aricept® should be taken at night, just prior to sleeping. If patient cannot endure 10mg/d，the patient can reduce to 5mg/d for 4 weeks and then increase back to 10mg/d. Patients who cannot endure the 10mg/d titration of 2nd time and then back to 5mg/d or discontinuance of Aricept® should be regarded as to quit the study. There will be a visting at week 0, the end of week 4 and the end of week 20 ,respectively.
16013285|NCT02787733|Dietary Supplement|Citrus flavonoid|Daily dose of 500mg divided over two capsules
16013286|NCT02787733|Dietary Supplement|Placebo|Daily dose of 500mg divided over two capsules
16013287|NCT02787720|Other|Family centered empowerment model|The intervention was conducting Family-Centered Empowerment Model. The intervention package had three steps including pre intervention, during intervention and post intervention. The model has four stages including Perceived threat, Problem solving, Educational partnership, and Evaluation
16013288|NCT02787720|Other|Continuous care model|The intervention was conducting Family-Centered Empowerment Model. The intervention package had three steps including pre intervention, during intervention and post intervention. The model has four stages including Orientation, Sensitization, Control, and Evaluation
16013289|NCT02787707|Drug|Persumac|2.7 grams Persumac powder (Iranian traditional medicine remedy composed from sumac and Bunium Persicum) every 8 hour
16013290|NCT02787707|Drug|lactose|2.7 grams Lactose every 8 hour
16013291|NCT02787694|Other|Factor Targeted Walking Training|Individuals walk on a treadmill for 30 minutes while exposed to either endurance, balance, challenge, strength, or speed focused approaches
16013292|NCT02787694|Device|treadmill|
16013293|NCT02787681|Device|NEMO Gauge|Measurement and adjustment of endotracheal tube position by stylet.
16013294|NCT02787668|Other|Carbohydrate-restricted diet|Participants will be randomized (20 per group) to the carbohydrate restricted diet (i.e., CHO <10%; fat >65%, protein 25%) or a low fat diet (CHO 55%; fat 20%; protein 25%) for 8 weeks. Individual counseling with the study physician and registered dietitian (RD) will be provided at baseline for initial assessment and diet instruction. Participants will meet with a RD for an individual counselling session at week 2, 4, and 6 of the diet intervention to ensure adherence to the diet prescription. Participants will be encouraged to keep track of dietary intake by using electronic food diaries (weeks 1-8) to review with the RD during individual counseling at week 2, week 4 and week 6.
16013295|NCT02787668|Other|Control, low-fat diet|Individual counseling with the study physician and registered dietitian (RD) will be provided at baseline for initial assessment and diet instruction. Participants will meet with a RD for an individual counselling session at week 2, 4, and 6 of the diet intervention to ensure adherence to the diet prescription. Participants will be encouraged to keep track of dietary intake by using electronic food diaries (weeks 1-8) to review with the RD during individual counseling at week 2, week 4 and week 6.
16013296|NCT02787655|Behavioral|Aerobic exercise + Cognitive Training Group|stationary bicycling
16013297|NCT02787655|Behavioral|Cognitive training Only|20 minutes of cognitive training using Mindfit program
16013298|NCT02787642|Drug|Olaparib|Olaparib will be administered per os bidaily, as appropriate assigned dose level, during 7.5 weeks (D1 to D52). Olaparib should be started one week before the start of radiotherapy and will be continued until the last day of radiotherapy. Beyond this period, Olaparib could be continued at the investigator's discretion and after sponsor authorization, until progression.
16013299|NCT02787642|Radiation|Concomitant Radiotherapy|Radiotherapy consists of fractionated focal irradiation at a dose of 1.8 Grays (Gy) per fraction given once daily five days per week (Monday through Friday) over a period of 6.5 weeks, for a total dose of 59.4 Gy. Radiotherapy starts at D8.
16013300|NCT02787629|Procedure|Simultaneous Intubation|Intubation with GlideScope and ETT inserted simultaneously
16013301|NCT02787629|Procedure|Standard Intubation|Intubation with GlideScope inserted first and ETT insertion after the GlideScope view is obtained
16013302|NCT02787616|Genetic|buccal swab|cheek swab for DNA sampling
16013303|NCT02787603|Other|Interruption of antibiotic treatment due to PCT measurement|In group A at day 5, if the patient shows no clinical signs of infection and PCT levels < 0,25ng/mL OR PCT > 0,25 ng/mL AND 80% reduction in comparison with day 0 PCT levels, antibiotic will be interrupted. If there is a constant level or decrease less than 80% when compared day 0 or 5, there is no change in antibiotic treatment.
16013306|NCT02787577|Behavioral|Sleep Lengthening|Behaviour change techniques targeting sleep hygiene
16013307|NCT02787564|Behavioral|Intervention Group|The intervention consists of providing free fruits and vegetables of the participants' liking for a period of 4 weeks. Each week, a total of 2 portions of either fruits and/or vegetables per day will be provided.
16013308|NCT02787551|Drug|Insulin glargine/lixisenatide fixed ratio combination|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous"
16013309|NCT02787551|Drug|liraglutide|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous"
16013310|NCT02787551|Drug|exenatide|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous"
16013311|NCT02787551|Drug|exenatide extended-release|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous"
16013312|NCT02787551|Drug|albiglutide|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous"
16013313|NCT02787551|Drug|dulaglutide|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous"
16013314|NCT02787551|Drug|Background therapy: Oral Anti-diabetic Drug (Metformin, Pioglitazone, SGLT2 inhibitor)|Pharmaceutical form: tablet Route of administration: oral If previously taken, doses to remain stable through the study.
16013315|NCT02787538|Behavioral|US-ANSWER-2 decision aid|US-ANSWER-2 will consist of: 1) an Information Module that presents effectiveness and side effects of each treatment option, and 2) an interactive Value Clarification Module that guides patients to consider what matter to them the most, and the pros and cons of each treatment option. Within the Information Module, the decision support information (i.e., the benefits and harms of treatment options) will be presented in narrated text, graphics, and a series of animated patient stories demonstrating attributes required for effective communication with doctors and significant others.
16013316|NCT02787538|Behavioral|Control group (Online medication guide)|Standard online medication guide.
16013317|NCT02787525|Other|Questionnaire|"A clinical sweep follow up will be performed in all patients of both groups and results will be analyzed. It will be in form of a standardized questionnaire and if necessary telephone interviews asking about thrombo-embolic events, stroke, death, any bleeding but also on their current medication, comorbidities (i.e. arterial hypertension, diabetes mellitus, renal impairment and liver disease), any hospitalizations and their quality of life. For all events, the source documents will be gathered from general physicians, cardiologists, hospitals or registry offices.
~The questionnaire will be sent by mail to the patients. If information is missing or unclear, patients and if necessary their treating physician will be contacted by phone."
16013318|NCT02787512|Device|Stent|Endoscopic biliary stent insertion
16013319|NCT02787499|Procedure|HIV-1 RNA Resistance Testing|Perform drug resistance on enrollment to guide management of virologic failure
16013320|NCT02787486|Other|Blood sampling for Laboratory Developed Test (LDT) analysis|Each enrolled subject, either in the first or second trimester, will donate up to 50 mL (just over 3 tablespoons) of whole blood for development of the LDT
16013321|NCT02787473|Drug|pemetrexed|Pemetrexed 500mg/m2 IV on day 1 every 4 weeks for 2 cycles
16013322|NCT02787473|Drug|cisplatin|Cisplatin 25mg/m2 IV on day 1-3 every 4 weeks for 2 cycles
16013323|NCT02787473|Radiation|thoracic radiation therapy|Chemoradiotherapy, radiation 60Gy with 2 cycles of pemetrexed+ carboplatin/cisplatin
16013324|NCT02787473|Drug|docetaxel|Docetaxel 60 mg/m2 IV on day 57 every 3 weeks for 2 cycles
16013325|NCT02787460|Behavioral|Behavioral Text Messages|
16013326|NCT02787447|Drug|TKI|Gefitinib 250mg po qd or Erlotinib 150mg po qd or Icotinib 125mg po tid
16013327|NCT02787447|Radiation|Thoracic Hypofractionated Radiotherapy|40-45 Gy/5-15f
16013328|NCT02787447|Drug|Thymosin Alpha 1|Initiating thymosin alpha 1 therapy(1.6mg, qd, d1-d14;1.6mg, biw, d15-d90) at the second week of radiotherapy.
16013329|NCT02787434|Other|Prostate Cancer Screening Decision Aid|All patients recruited to the study will receive the PCSPrep decision aid. There is only 'study arm.' The Clinical Research Coordinator (CRC) will provide the patient with an iPad to complete the pre-test, PCSPrep and post-test. Individuals will see the survey questions on screen and will hear accompanying audio through headsets. Participants will: (1) be introduced to PCSPrep and the menu of activities/topics; (2) enter information about themselves for personal tailoring (e.g., risk factors); (3) participate in a values-clarification exercise to rate the personal importance of varied courses of action (i.e., pros/cons of PCS); (4) receive a printout with an individualized plan for discussing PCS with their primary care provider.
16013330|NCT02787421|Device|Breathe-Rite Nasal Dilator Strip|During the pre-operative clinic visit, participants will be given a Breathe-Rite Nasal Dilator Strip
16013331|NCT02787408|Device|EW Tricuspid Transcatheter Repair System|Treatment with the EW Tricuspid Transcatheter Repair System
16013332|NCT02787395|Procedure|shoulder dislocation self reduction|shoulder dislocation self reduction using one of three methods in the study
16013333|NCT02787382|Device|echocardiographic examination|"Patients will undergo echocardiography (us) starting at the time of the first referral and every 3-4 weeks until delivery and at the 2-7th day birth. Cardiac scans of fifty pregnant women the healthy women from the group will serve as controls at the 2-7th day birth. Cardiac scans of fifty pregnant women and the healthy women from the group will serve as controls
~EXPECTED RESULTS Subtle myocardial deformation abnormalities are expected to be commonly found in fetuses and infants with CMV infection."
16013334|NCT02787369|Drug|ACY-1215|
16013335|NCT02787369|Drug|Ibrutinib|
16013336|NCT02787369|Drug|Idelalisib|
16013337|NCT02787356|Drug|TDS Lidocaine 5%; generic|TDS Lidocaine 5%; generic
16013338|NCT02787356|Drug|TDS Lidocaine 5%; RLD|TDS Lidocaine 5%; RLD
16013339|NCT02787330|Behavioral|Control Group|Sessions will not be designed around a specific theme related to childhood cancer and sibling relationships. Activities and games will not have a specific focus. CG sessions will be conducted by facilitators who will receive the standard training for volunteers and will work under the supervision of one of the investigators at each site.
16013340|NCT02787330|Behavioral|Experimental Group|The experimental group will be detailed, session by session, in the manual written for this purpose. It addresses on topic per session (respecting each other, medical information about cancer, family relationships, sibling's fears and feelings, relationship between siblings, relationships at school, generating hope.
16013341|NCT02787317|Drug|bivalirudin|Bivalirudin is an alternative to heparin in patients undergoing percutaneous coronary intervention.
16013342|NCT02787317|Drug|Heparin|Heparin is used in patients undergoing percutaneous coronary intervention.
16013343|NCT02787304|Drug|SHP626|5 mg, 10 mg, and 20 mg of SHP626 capsule by orally once daily in a double-blinded fashion
16013344|NCT02787304|Drug|Placebo|Matching placebo
16013345|NCT02787291|Device|Ellipse VR ICD and Durata/Optisure lead|Non-diagnostic MRI Scan sequence of head and chest
16013346|NCT02787278|Drug|SP-8203 High dose|High-dose group: 160mg will be intravenously administered as 80mg/dose twice daily (intervals of 12 hours).
16013347|NCT02787278|Drug|SP-8203 Low dose|Low dose group: 80mg will be intravenously administered as 40mg/dose twice daily (intervals of 12 hours).
16013348|NCT02787278|Drug|Placebo|Same dosage of SP8203. Placebo will be intravenously administered twice daily (intervals of 12 hours)
16013349|NCT02787265|Device|spinal cord stimulation|
16013350|NCT02787252|Device|Implant procedure, Freedom Spinal Cord Stimulation System|A needle is carefully inserted near the spinal cord. The stimulator is then slide through the needle to lay close to the spinal cord. The end of the stimulator is then sutured underneath the skin of the back.
16013351|NCT02787239|Drug|HLX01|
16013352|NCT02787239|Drug|Rituximab|
16013353|NCT02787239|Drug|CHOP|
16013354|NCT02787226|Drug|Liposomal Bupivacaine Infiltration|Surgical wound infiltration of 266 mg of 1.3% liposomal bupivacaine suspension.
16013355|NCT02787226|Drug|Continuous Perineural Ropivicaine Infusion|Indwelling interscalene catheter with a continuous infusion of 6ml per hour of 0.2% ropivacaine.
16013356|NCT02787187|Procedure|Pancreaticoduodenectomy with Standard lymphadenectomy|Pancreaticoduodenectomy：child's digestive reconstruction standard lymphadenectomy: No 5 6 8a 12b1 12b2 12c 13a 13b 14a 14b 17a 17b
16013357|NCT02787187|Procedure|Pancreaticoduodenectomy with Extended lymphadenectomy|Pancreaticoduodenectomy：child's digestive reconstruction extended lymphadenectomy: No8p 12a 12p 14c 14d 16
16013358|NCT02787174|Other|Asthma Medication Adherence Education|
16013359|NCT02787161|Device|Hemodiafiltration|High volume online HDF
16013360|NCT02787161|Device|Hemodialysis|High-flux HD
16013361|NCT02787148|Behavioral|Cognitive behavioral therapy|
16013362|NCT02787135|Behavioral|emotion-oriented Cognitive Behavior Therapy|Emotion-oriented Cognitive Behavior Therapy with a focus on delusions: Aim of the intervention is to change factors that are involved in the formation and maintenance of delusions: emotional stability and regulation of negative emotions, sleep quality and self-esteem.
16013363|NCT02787122|Behavioral|CBT-E|Patients receive 25 sessions of individual emotion-focused Cognitive Behavior Therapy based on a manual. Interventions aim on patients' mood by implementing positive activities in their daily routine. Further, patients train to reduce worrying behavior. Social contacts are fostered as well. Later, patients are informed on emotions and train emotion regulation strategies. Finally, the focus of CBT-E is on self-acceptance.Patients receive psychoeducation on self-acceptance and learn strategies in order to reduce negative self-schema and foster positive self-schema.
16013364|NCT02787122|Behavioral|Treatment as Usual|Patients receive standardized treatment. After a waiting period of six month, patients receive CBT-E
16013365|NCT02787109|Biological|CTH522-CAF01|CTH522 chlamydia antigen adjuvanted with CAF01 for IM administration
16013366|NCT02787109|Biological|CTH522-Al(OH)3|CTH522 chlamydia antigen adjuvanted with aluminium hydroxide, Al(OH)3 , for IM administration
16013367|NCT02787109|Biological|Placebo|Saline
16013368|NCT02787096|Device|LaxIRM|Dynamic knee laxity measurement coupled to MRI for the diagnosis of ACL tear
16013369|NCT02787083|Drug|Mirabegron|
16013370|NCT02787083|Drug|Placebo|
16013371|NCT02787070|Drug|PQ supervised|
16013372|NCT02787070|Drug|PQ unsupervised|
16013373|NCT02787057|Drug|vancomycin|IP vancomycin 1g every 5 days
16013374|NCT02787057|Drug|moxifloxacin|oral moxifloxacin 400mg QD
16013375|NCT02787057|Drug|ceftazidime|IP ceftazidime 1g QD
16013376|NCT02787044|Biological|High Dose Trivalent Influenza Vaccine|High Dose Trivalent Influenza Vaccine
16013377|NCT02787044|Biological|Standard Dose Quadrivalent Influenza Vaccine|Standard Dose Quadrivalent Influenza Vaccine
16013378|NCT02787031|Procedure|Neuraxial anesthesia|
16013379|NCT02787031|Procedure|General anesthesia|
16013380|NCT02787018|Drug|Ropivacaine and Normal saline|Supraclavicular brachial plexus block will be given with 0.5% ropivacaine with 1 ml normal saline
16013381|NCT02787018|Drug|Ropivacaine and Dexamethasone|Supraclavicular brachial plexus block will be given with 0.5% ropivacaine with 4mg (1ml) dexamethasone
16013382|NCT02787018|Drug|Ropivacaine and Dexmedetomidine|Supraclavicular brachial plexus block will be given with 0.5% ropivacaine with 50 mcg (1ml) dexmedetomidine
16013383|NCT02787005|Biological|Pembrolizumab|Intravenous infusion
16013384|NCT02787005|Drug|Enzalutamide|Oral capsules
16013385|NCT02786992|Drug|Misoprostol|
16013386|NCT02786992|Drug|Oxytocin|
16013387|NCT02786992|Drug|Carbetocin|
16013388|NCT02786992|Drug|Placebo|
16013389|NCT02786979|Drug|Beraprost|Oral
16013390|NCT02786979|Drug|Aspirin|Oral
16013391|NCT02786966|Other|Canadian C-Spine Rule|Paramedic assessment for potential cervical spine injuries using the Canadian C-Spine Rule
16013392|NCT02786953|Behavioral|Sleep Promotion|Behavioral intervention to improve sleep quality and duration.
16013393|NCT02786940|Device|Cardiophone|Remote live monitoring for 15 days for detection or exclusion of arrhythmias
16013394|NCT02786927|Drug|Placebo ELLIPTA device|Placebo ELLIPTA is a DPI device containing powder for inhalation, to be inhaled orally once daily for 5-9 days. It contains two strips with 30 blisters per strip - one strip contains lactose monohydrate whereas the other strip contains lactose monohydrate blended with magnesium stearate.
16013395|NCT02786927|Drug|Placebo capsules for use in HANDIHALER device|Placebo capsules contain lactose monohydrate in the form of powder for inhalation, to be used with the HANDIHALER inhaler as an oral inhalation once daily for 5-9 days.
16013396|NCT02786927|Other|Inhaler Preference Questionnaire Version 1|Consists of 5 questions to assess subjects' preference of device attributes and dosing regimens. The two versions of the questionnaire ask the same questions, but differ in the ordering of inhalers in their responses.
16013397|NCT02786927|Other|Inhaler Preference Questionnaire Version 2|Consists of 5 questions to assess subjects' preference of device attributes and dosing regimens. The two versions of the questionnaire ask the same questions, but differ in the ordering of inhalers in their responses.
16013401|NCT02786875|Other|low Glycemic Index Mediterranean diet|All carbohydrate foods will be low GI choices (GI<70 on bread scale, e.g. legumes, pasta al dente, barley, oat, apples, oranges, berries, nuts) within a healthy Mediterranean diet (≥5 servings veg/fruit per day, ≤1 serving red meat+cold cuts/week, <7% SFA).
16013402|NCT02786875|Other|Mediterranean diet|General recommendations for a healthy Mediterranean diet (≥5 servings veg/fruit per day, ≤1 serving red meat+cold cuts/week, <7% SFA).
16013403|NCT02786875|Behavioral|Moderate physical activity|Brisk walk of at least 30min per day (or approximately 5000 steps) more than the habitual physical activity.
16013404|NCT02786875|Behavioral|Basic physical activity|General recommendations for physical activity
16013405|NCT02786875|Drug|high level Vitamin D|Vitamin D supplement (cholecalciferol) up to 4000 IU/day to reach normal blood levels of 60-80 ng/ml of 25(OH)D.
16013406|NCT02786875|Drug|normal level Vitamin D|Vitamin D (cholecalciferol) will be given only if vitamin D insufficiency is detected to bring blood levels up to normal ranges of 30ng/mL.
16013407|NCT02786862|Other|independent ventilation|comparison conventional and independent 1:1 ventilation
16013408|NCT02786849|Other|neuromuscular electrical stimulation of high frequency and intensity|"Training with neuromuscular electrical stimulation isometric form in lateral and medial bilaterally vast, three times a week, lasting an hour, the first two hours of dialysis.
~Will be applied using portable stimulators with 4 channels. The parameters are: frequency of 50 Hz, pulse width 400ms, rise time and 2s descent, stimulus mode on-off starting with a ratio of 1: 2 in the first week (stimulus time of 10 seconds and rest time of 20s, aiming at adaptation and mitigation of the effects of muscle fatigue), evolving from the second week to a ratio of 1:1 (stimulation time of 10 seconds and rest time of 10s).
~The current intensity is adjusted individually for the first application and gradually increased as the tolerance of patients.
~In each session there will be a warm-up period, training and slowdown. The intensity will be the maximum tolerated by the patient in order increments every session, this being monitored for further evolutionary calculating."
16013409|NCT02786849|Other|neuromuscular electrical stimulation of low frequency and intensity|"Training with neuromuscular electrical stimulation isometric form in lateral and medial bilaterally vast, three times a week, lasting an hour, the first two hours of dialysis.
~Will be applied using portable stimulators with 4 channels. The parameters are: 5 Hz frequency, time on: off 1: 3 with a pulse duration of 100ms.
~The current intensity is adjusted individually for the first application and it was the least noticeable by the patient.
~In each session there will be a warm-up period, training and slowdown."
16013410|NCT02786836|Drug|13C-Methacetin|"The test substrate in this study, ¹³C-methacetin solution for single-use oral administration (75 mg in 150 ml purified water), is administered orally or via feeding tube, rapidly absorbed, exclusively metabolized by hepatic mixed function oxidase via O-demethylation, mainly by cytochrome P450 enzyme, subtype 1A2, into acetaminophen and formaldehyde. The formaldehyde is then transformed through two successive oxidative steps to ¹³carbon dioxide, the quantity of which is measured in exhaled breath as a ratio of 13C to 12C.
~The nasal or intubated breath sampling investigational device (ID) circuit continuously transports the breath sample from the patient to the BreathID® MCS device before and following administration of the 13C-methylacetanilide test substrate."
16013411|NCT02786823|Dietary Supplement|Folic acid|tab. Folic acid 5 mg
16013412|NCT02786823|Dietary Supplement|Vitamin B12|tab. Vitamin B12 500 mcg
16013413|NCT02786823|Drug|Oral hypoglycemic agents [Metformin +/- Sulfonylurea]|"Patients receiving either of the following oral hypoglycemic agents
~Sulfonylurea
~Metformin
~Metformin plus Sulfonylurea"
16013414|NCT02786810|Drug|Sulfur hexafluoride type-a lipid microspheres|Used as a contrast to enhance renal ultrasound
16013415|NCT02786797|Behavioral|MBSR(BC) 6 Week Program|The MBSR(BC) is a clinical program that provides systematic training to promote stress reduction by self-regulating arousal to stress. The goal of training is to teach participants to become more aware of their thoughts and feelings, and through meditation practice, to have the ability to step back from thoughts and feelings during stressful situations that contribute to increased emotional distress. It incorporates simple yoga, sitting meditation, body scan, and walking meditation in this program. Classes for this intervention occur on a weekly basis for 2 hours for 6 weeks. The participants will be asked to record their informal/formal practices in a daily diary during the program and from 6 weeks to 6 months after the intervention.
16013416|NCT02786797|Behavioral|BCES 6 Week Program|"The BCES is an education support program. This 6-week program is based on the published NIH program, Support for People with Cancer: Taking Time Education Support Group. In addition the class sessions consist of group discussion of educational materials and homework assignments; and group processes related to sharing supportive care situations. The participants will record their feelings, coping mechanisms, and questions related to survivorship in a daily diary during the program and from 6 weeks to 6 months after the intervention."
16013417|NCT02786784|Other|6 week exercise treatment|This six-week exercise programme was developed based on the current recommendations, consisting of four exercises to strengthen gluteus medius and maximus muscle, as well as the quadriceps muscle. In addition, two exercises to stretch the hamstrings muscles and to increase the ankle dorsi range of motion were included.
16013418|NCT02786771|Device|Spire|
16013419|NCT02786771|Device|Muse headband|
16013420|NCT02786732|Biological|210mg Brodalumab|Brodalumab 210mg administered subcutaneously
16013421|NCT02786732|Biological|140mg Brodalumab|Brodalumab 140mg administered subcutaneously
16013422|NCT02786732|Biological|Ustekinumab|Ustekinumab 45mg or 90mg adminstered subcutaneously
16013423|NCT02786732|Biological|Placebo|Placebo administered subcutaneously
16013424|NCT02786719|Drug|Topotecan|CYCLE 1+2 (given by intravenous catheter daily for 5 days)
16013425|NCT02786719|Drug|Cyclophosphamide|CYCLE 1+2 (given by intravenous catheter daily for 5 days)
16013426|NCT02786719|Drug|Cisplatin|Cycle 3+5 (given daily x 4 days)
16013427|NCT02786719|Drug|Etoposide|Cycle 3+5 (given daily for 3 days)
16013428|NCT02786719|Drug|Vincristine|Cycle 4+6 (given daily for 3 days)
16013429|NCT02786719|Drug|Cyclophosphamide|Cycle 4+6 (given daily for 2 days)
16013430|NCT02786719|Drug|Doxorubicin|Cycle 4+6 (given daily for 3 days)
16013431|NCT02786719|Drug|Sargramostim|Granulocyte macrophage colony stimulating factor (rhu GM-CSF, rGM-CSF, GM-CSF)
16013508|NCT02786082|Drug|20mg Azilsartan Tablets|Strength: 20mg, oral administration 1 tablet/ day
16072705|NCT02363335|Drug|Placebo|
16013432|NCT02786706|Device|Optic nerve ultrasound|All patients will undergo Optic Nerve Ultrasound (ONUS), with measurement of Optic Nerve Sheath Diameter (ONSD) by both an expert investigator as well as by the automated image analysis algorithm.
16013433|NCT02786680|Behavioral|stroop test in condition DBS off|Patients were evaluated in DBS Off
16013434|NCT02786680|Behavioral|stroop test in condition DBS on|Patients were evaluated in DBS On
16013435|NCT02786667|Drug|Rotigotine|6 months treatment with Rotigotine up to 8 mg per day with a titration period for one month
16013436|NCT02786667|Drug|Placebo|6 months treatment with Placebo up to 8 mg per day with a titration period for one month
16013437|NCT02786641|Drug|Docetaxel|Docetaxel 65mg/m2 in induction chemotherapy
16013438|NCT02786641|Drug|Cisplatin 1|Cisplatin 75mg/m2 in induction chemotherapy
16013439|NCT02786641|Drug|Xeloda|Xeloda 2000mg/m2 D1-14 in induction chemotherapy
16013440|NCT02786641|Radiation|IMRT|IMRT for all patients
16013441|NCT02786641|Drug|Cisplatin 2|Cisplatin 100mg/m2 in concurrent chemotherapy
16013442|NCT02786628|Other|Physical performance testing and patient-generated health data|All patients will complete cardiopulmonary exercise testing and 6 minute walk distance performance testing prior to a cycle of chemotherapy (or transplant) and wear a Fitbit Charge HR for the duration of one cycle of chemotherapy.
16013443|NCT02786615|Behavioral|Peer Unity|A 4-session, group-delivered intervention focusing on peer/social network-based recruitment and referral program to receive HIV prevention and treatment services in the community.
16013444|NCT02786602|Genetic|pyrosequencing|
16013445|NCT02786589|Biological|Blood-stage infection of P. vivax|Each patient will be vaccinated with P. vivax-infected red blood cells containing approximately 0.3-1×10^7 Plasmodium parasites.And successful infection will be indicated by microscopic observation of parasitemia in peripheral blood samples.The treatment will last at least 12 weeks from the day of finding the Plasmodium from peripheral blood and will be terminated by chloroquine phosphate or Artemisinin compound preparation or Artesunate injection.
16013446|NCT02786550|Drug|Botulinum Toxin|A total of 7.5U per side of botulinum toxin will be injected to the lateral part of obicularis oculis muscle (3 injections of 2.5 U).
16013447|NCT02786550|Other|Normal Saline|The same amount (3 cc) of Normal saline will be injected to the lateral part of obicularis oculis muscle
16013448|NCT02786537|Drug|SOF/LDV (sofosbuvir/ledipasvir)|Sofosbuvir/Ledipasvir (400/90 mg) for approximately 12 to 24 weeks (treatment duration and use of ribavirin is per discretion of HCV provider)
16013449|NCT02786537|Drug|PrOD (ombitasvir/paritaprevir/ritonavir with dasabuvir) (Phase 1 only)|Ombitasvir/paritaprevir/ritonavir (12.5/75/50mg) (2 tablets taken orally) and Dasabuvir (250 mg tablet) (1 tablet twice daily) with food for 12 to 24 weeks (treatment duration as per HCV provider)
16013450|NCT02786537|Drug|EBR/GZR (elbasvir/grazoprevir)|Elbasvir/grazoprevir (50/100mg) tablet once daily with or without food with or without RBV for 12 to 16 weeks
16013451|NCT02786537|Drug|Ribavirin|200 mg pills (1-3 pills, 1-2 times per day)
16013452|NCT02786524|Behavioral|Specialized Symptom Management and Supportive Care|Based on Patients who score 5 or higher on the Baseline Patient Palliative Care Survey that will identify patients that will most benefit from specialty palliative care
16013453|NCT02786511|Drug|Safety and efficacy assessments|Vector copy number (VCN) measurement, safety evaluations, disease-specific assessments, and assessments to monitor for long-term implications of autologous transplant
16013454|NCT02786498|Drug|Vitamin D3|
16013455|NCT02786498|Other|Placebo|
16013456|NCT02786485|Biological|rivogenlecleucel|T cells transduced with iCasp safety switch
16013457|NCT02786485|Drug|Rimiducid|administered to treat GVHD
16013458|NCT02786472|Behavioral|Online Bystander Training|Large groups of 120-150 students will complete Haven training via computer; training lasts duration of the online program.
16013459|NCT02786472|Behavioral|Online Substance Abuse Training|Large groups of 120-150 students will complete EverFi training via computer; training lasts duration of the online program.
16013460|NCT02786472|Behavioral|In-Person Bystander Training|In-person training of large groups of 120-150 students; training lasts 3-4 hours
16013461|NCT02786472|Behavioral|In-Person Combination Training|In-person training of large groups of 120-150 students; training lasts 3-4 hours
16013462|NCT02786459|Device|ProxiScan|ProxiScan probe will be coupled with ProstaScint (a radioactive tracer) and used to perform imaging to detect small lesions in the pelvis that will otherwise be hard to detect with conventional imaging modalities.
16013463|NCT02786459|Device|Magnetic Resonance Imaging|Used as a comparative to ProxiScan.
16013464|NCT02786459|Device|SPECT-CT|Used as a comparative to ProxiScan.
16013465|NCT02786446|Drug|Lidocaine gel,|2% lidocain gel will be applied to coresponding lumber area 30 minutes before ESWL for renal stones. Maximum of 4000 shock waves will be delivered. Rescue analgesia will be given as intravenous nalbuphine if patient demanded. Pain score is measured with visual analogue pain score from 1 to 10 after completion of procedure if patient donot needed rescue analgesia and during procedure just before giving rescue analgesia in those who demanded it.
16013466|NCT02786446|Drug|Naproxen Sodium|Tab Naproxen sadium 550 mg per oral will be given to patients 30 minutes before ESWL for renal stones. Maximum of 4000 shock waves will be delivered. Rescue analgesia will be given as intravenous nalbuphine if patient demanded. Pain score is measured with visual analogue pain score from 1 to 10 after completion of procedure if patient donot needed rescue analgesia and during procedure just before giving rescue analgesia in those who demanded it.
16013467|NCT02786446|Drug|Lidocaine gel and Naproxen Sodium|Tab Naproxen sodium 550 mg per oral will be given to patients 45 minutes before ESWL and 2% lidocain gel will be applied to coresponding lumber area 30 minutes before ESWL for renal stones. Maximum of 4000 shock waves will be delivered. Rescue analgesia will be given as intravenous nalbuphine if patient demanded. Pain score is measured with visual analogue pain score from 1 to 10 after completion of procedure if patient donot needed rescue analgesia and during procedure just before giving rescue analgesia in those who demanded it.
16013468|NCT02786433|Other|conventional physiotherapy|
16013469|NCT02786433|Other|Virtual Reality with X- Box Kinect®|
16013470|NCT02786407|Drug|Botulinum Toxin Type A for Injection|In these studies,patients received a minimum intramuscular(IM) dose of 100U of Botulinum Toxin Type A administered to 20 injection sites
16013471|NCT02786407|Drug|Placebo|In these studies,patients received placebo administered to 20 injection sites
16013472|NCT02786394|Behavioral|REACH|REACH is a lifestyle intervention program which aims to reduce sedentary behaviour, increase physical activity, and increase strength and balance. The REACH program is comprised of six sessions which include evidence-based education, behaviour change theory, and activity instruction. REACH also teaches goal setting techniques, mindfulness, and encourages active community engagement. In this study we are running the REACH program for women aged 55 and older alongside a supplementary optional walking program run by SportMedBC.
16013473|NCT02786368|Behavioral|Control group|A comparison group; no intervention for year 1, EHFP after 1 year of program implementation.
16013474|NCT02786368|Behavioral|EHFP group|Intervention group: training; inputs cost-sharing for EHFP activities.
16013475|NCT02786355|Other|Frova bougie|Squeezing an Ambu bag and delivering air through a Frova bougie. Measuring mean volumes of air delivered and peak pressures generated.
16013476|NCT02786342|Procedure|blood sample collection|
16013477|NCT02786329|Drug|TIVA+lidocaine|Patients will be subjected to total intravenous anesthesia with propofol-fentanyl+i.v. lidocaine infusion for the first 48 h postoperatively
16013478|NCT02786329|Drug|Sevoflurane+lidocaine|Patients will be subjected to anesthesia with sevoflurane- fentanyl + lidocaine infusion for the first 48 h postoperatively.
16013479|NCT02786329|Drug|TIVA+placebo|Patients will be subjected to TIVA with propofol-fentanyl + saline infusion for the first 48 h postoperatively
16013480|NCT02786329|Drug|Sevoflurane+placebo|Patients will be subjected to anesthesia with sevoflurane-fentanyl + saline infusion for the first 48 h postoperatively
16013481|NCT02786316|Other|HIT program|HIT program for the rehabilitation of persons with NSCLBP
16013482|NCT02786316|Other|conventional rehabilitation program|a conventional rehabilitation program in persons with NSCLBP
16013483|NCT02786303|Device|Whole-body diffusion- weighted MRI|
16013484|NCT02786290|Device|Zenflow Spring System|The Zenflow Spring is a nitinol urethral implant for the treatment of Lower Urinary Tract Symptoms (LUTS) that arise due to bladder outlet obstruction (BOO), secondary to the presence of Benign Prostatic Hypertrophy (BPH). The device is intended to be a permanent implant however it may be removed if necessary.
16013485|NCT02786277|Other|Alert|An alert informing the provider of the presence of acute kidney injury will be fired.
16013486|NCT02786264|Drug|Dexmedetomidine|A dexmedetomidine- dominant anesthetic will be defined as an anesthetic that included a continuous infusion of dexmedetomidine within 15 minutes of anesthesia start.
16013487|NCT02786264|Drug|Propofol|A propofol-dominant anesthetic will be defined as an anesthetic that included a continuous infusion of propofol within 15 minutes of anesthesia start.
16013488|NCT02786264|Drug|Fentanyl and/or Midazolam|A fentanyl / midazolam dominant anesthetic will be defined as monitored anesthesia care in the presence of fentanyl or midazolam and in the absence of a propofol or dexmedetomidine infusion.
16013489|NCT02786251|Other|Cold exposure|During cold exposure intervention, we will use an individualized cold exposure protocol above the individual shivering threshold of each participant using liquid condition garments and a temperature controlled room.
16013490|NCT02786251|Other|Exposure to thermoneutral conditions|For the thermoneutral conditions intervention, subjects will be exposed to thermoneutral conditions (~26-28°C).
16013491|NCT02786238|Behavioral|Standard Behavioral Treatment (SBT)|See description of treatment arm.
16013492|NCT02786238|Behavioral|Acceptance-Based Treatment (ABT)|See description of treatment arm. **Cherokee Nation members receive only the ABT intervention as they are in an open, feasibility trial and are not randomized.**
16013493|NCT02786225|Behavioral|Collaborative Care|Intervention Group: Women (n=118) will be seen one time, simultaneously by a VUMC perinatologist and a VUSN nurse-midwife (the CARE visit). During the CARE visit, the nurse-midwife and perinatologist will complete the CARE checklist The checklist will be signed by the woman and providers and scanned into the medical record. Following the CARE visit, women will return to midwifery care or be referred to perinatology depending on their needs, remaining in the study. Women returning to the midwifery practice will see a primary midwife for the remainder of care.
16013494|NCT02786225|Behavioral|Comparison Care- Usual Care + primary midwife|Comparison Group: Usual care enhanced with primary midwife. Women in the comparison group (n=118) will receive the standard individual consult visit with a perinatologist and then, if they return to midwifery care, have one consistent midwife (primary midwife) for the majority of remaining prenatal care.
16013495|NCT02786212|Drug|Dexmedetomidine|
16013496|NCT02786212|Drug|Normal Saline|
16013497|NCT02786186|Drug|Secikinumab|
16013498|NCT02786160|Dietary Supplement|HMO|
16013499|NCT02786160|Dietary Supplement|Dextropur|
16013500|NCT02786147|Other|Breast Cancer Genetics Referral Screening Tool 3.0|"The B-RST is a simple yet effective validated screening tool to quickly identify individuals who may be at risk for hereditary breast and ovarian cancer and should be referred for cancer genetic counseling to formally evaluate their family history and discuss the benefits and limitations of genetic testing for hereditary breast and ovarian cancer.
~Clinic staff will give each patient arriving for a screening mammogram appointment a packet and briefly inform them about the opportunity to participate in a research study and that these materials can help them decide whether or not to participate.
~Patients who indicate that they are interested in completing the B-RST screening while in the clinic will be provided with an electronic tablet that has a secure internet browser tab open to the web-based study version of the screening tool (the B-RST 3.0)."
16013501|NCT02786147|Other|Standard Handout|A document explaining the patient's positive test result indicating that they are at increased risk for HBOC (Hereditary Breast or Ovarian Cancer) which includes information on how to obtain cancer genetics services through Winship.
16013502|NCT02786147|Other|Physician Notification|Primary care physician or ordering physician will be notified vie EeMR that the patient screened positive on the B-RST. The note provides specific instructions on how to refer the patient for cancer genetic counseling services.
16013503|NCT02786147|Other|Automatic Follow-Up by Genetic Counseling Staff|Within 1-2 weeks after the mammogram appointment, patients will receive a phone call from a genetics counseling staff person to explain their screening result and to offer to set up a genetics counseling appointment.
16013504|NCT02786134|Radiation|PET scan|A cardiac PET scan will be performed at baseline (main CIRT trial randomization) and at 12-months.
16013505|NCT02786134|Radiation|Echocardiogram|An echocardiogram will be performed at baseline (main CIRT trial randomization) and at 12-months.
16013509|NCT02786082|Drug|40mg Azilsartan Tablets|Strength: 40mg, oral administration 1 tablet/ day
16013510|NCT02786069|Drug|Propionyl L-carnitine Hydrochloride|500mg/ tablet; for oral administration, 1 dosage form is set for this trial: 1g, 2g and 4g.
16013511|NCT02786056|Other|Lung MRI examination|Lung MRI examination is performed for approximately 30 min on a 3T machine (Achieva 3T, Philips) using UTE sequences, both during free breathing with image synchronisation using an echo-navigator, and during an end-inspiratory and end-expiratory pauses. In the 10 first subjects, the MR protocol is optimized in order to maximize MRI parenchymal signal intensity, signal-to-noise ratio and contrast-to-noise ratio. The final image acquisition parameters will be applied in the following 30 subjects in order to assess the outcomes of the study.
16013512|NCT02786043|Drug|Propionyl-L-Carnitine Hydrochloride|1g twice a day on first 4 days and 1g/ day on day 5 during Phase III
16013513|NCT02786030|Behavioral|Outreach education training|Printed copies of the patient management tool (PMT) and outreach education training
16013514|NCT02786030|Behavioral|No outreach education training|Printed copies of the patient management tool (PMT) without outreach education training
16013515|NCT02786017|Biological|Conventional therapy|Patients will receive the conventional therapy.
16013516|NCT02786017|Biological|Injectable Collagen Scaffold + HUC-MSCs|Injectable collagen scaffold combined with HUC-MSCs was injected into left lateral segment, left medial segment, right anterior segment, right posterior segment and caudate lobe under B-mode ultrasound supervision, respectively. The total amount of HUC-MSCs was 5*10^8.
16013517|NCT02786004|Device|Full Field Digital Mammography|
16013518|NCT02786004|Device|Digital Breast Tomosynthesis|
16013519|NCT02785991|Procedure|Balloon cryoablation|pulmonary vein cryoablation for atrial fibrillation
16013520|NCT02785978|Drug|Levodopa acute challenge|"Inclusion visit (simultaneous video + ActiMyo recording):
~Levodopa acute challenge and 2 hours of recording and medical monitoring"
16013521|NCT02785978|Other|Controlled environment tests (series of tasks of everyday life)|"Inclusion visit (simultaneous video + ActiMyo recording):
~Controlled environment tests (series of tasks of everyday life)"
16013522|NCT02785978|Other|Standardized scales: MDS-UPDRS (Part II to IV) and RDRS|"Inclusion visit (simultaneous video + ActiMyo recording):
~Standardized scales: MDS-UPDRS (Part II to IV) and RDRS"
16013523|NCT02785978|Device|ActiMyo recording|Continuous activity recording with ActiMyo during the 2 weeks of study participation
16013524|NCT02785978|Other|Diary completion|Daily patient logbook completion during the 2 weeks of study participation
16013525|NCT02785965|Device|electroacupuncture|Disposable, single-use, sterilized stainless-steel needles (Yunlong, Beijing, China; length 40/100 mm, diameter 0.30 mm) are inserted into waist, bilaterally. All of the six points are located in the Dai Meridian route corresponding to the ovaries. Four needles, 0.25mm in diameter and 25mm in length, are also placed in distal acupuncture points which are located in the feet and lower arms to enhance local points' effects. Acupuncture needles of 0.3mm in diameter and 100mm in length are inserted into GB26(Daimai) with a depth of 25-65mm by an angle of 15°, following the path of Dai Meridian (towards medial and downside). The other needles are inserted vertically into the acupoints with a depth of 10-30mm, depending on the thickness of muscles. Electro-acupuncture is applied to both sides of GB26 and ST25(Tianshu): cathode is connected to GB26; anode to ST25. Needles are stimulated electrically with low frequency (2 Hz) for 20 min.
16013526|NCT02785965|Behavioral|lifestyle modification|The diet restricts patients to 1400 calories a day for 12 weeks.The exercise included 12 weeks of aerobic exercise in moderate level (60 to 70% of maximum heart rate), for 3 sessions a week, each session for 60 min. The exercises included: Warning up: 10 min, main phase (aerobic exercise): 40 min and cooling down: 10 min. Polar Pulse measuring device from China was used to control the intensity of the exercises.
16013527|NCT02785952|Biological|Ipilimumab|Given IV
16013528|NCT02785952|Other|Laboratory Biomarker Analysis|Correlative studies
16013529|NCT02785952|Biological|Nivolumab|Given IV
16013530|NCT02785952|Other|Quality-of-Life Assessment|Ancillary studies
16013531|NCT02785952|Other|Questionnaire Administration|Ancillary studies
16013532|NCT02785939|Drug|Docetaxel|Given IV (arm II closed to accrual 12/18/2015)
16013533|NCT02785939|Other|Laboratory Biomarker Analysis|Correlative studies
16013534|NCT02785939|Drug|Palbociclib|Given PO
16013535|NCT02785913|Other|Laboratory Biomarker Analysis|Correlative studies
16013536|NCT02785913|Drug|Taselisib|Given PO
16013537|NCT02785900|Drug|33A|33A, 10 mcg/kg, every 4 weeks via intravenous (IV) push
16013538|NCT02785900|Drug|placebo|Volume equivalent to 10 mcg/kg, every 4 weeks via IV push
16013539|NCT02785900|Drug|azacitidine|75 mg/m2 given subcutaneously (SC) or IV x 7 days, every 4 weeks
16013540|NCT02785900|Drug|decitabine|20 mg/m2 given IV x 5 days, every 4 weeks
16013541|NCT02785887|Other|Geriatrician review|In addition to routine oncological care, patients will be reviewed by a geriatrician and may receive intervention if CGA deficits are found
16013542|NCT02785874|Drug|Statin|Divide HCC patients into two groups under randomization, one is with Statin and the other is without Statin to verify whether Statin could prolong disease-free survival
16013543|NCT02785861|Behavioral|supervision of physical activity|
16013544|NCT02785861|Behavioral|distance supervised physical activity|
16013545|NCT02785848|Other|Interviews and Surveys|The investigators will perform semi-structured interviews and surveys on this cohort
16013546|NCT02785822|Drug|hMG-HP|Ovarian stimulation with hMG-HP (150 IU / day)
16013547|NCT02785822|Drug|hFSH-HP|Ovarian stimulation with hFSH-HP (150 IU / day)
16013548|NCT02785809|Other|Pausing oral contraceptive|
16013549|NCT02785796|Other|CV4|
16013550|NCT02785796|Other|SHAM TECHNIQUE|
16013551|NCT02785783|Device|Standard colonoscopy|
16013552|NCT02785783|Device|EndoRings™|Colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope
16013553|NCT02785770|Drug|PF-04447943|Single oral dose of PF-04447943 administered as an extemporaneously prepared solution
16013554|NCT02785770|Drug|Placebo|Single oral dose of matching placebo for PF-04447943 administered as an extemporaneously prepared solution
16013555|NCT02785770|Drug|Moxifloxacin|Single oral dose of moxifloxacin administered as tablet
16013556|NCT02785757|Other|Thrombin Generation Assay|
16073277|NCT02358928|Other|Diet Intervention|
16013558|NCT02785731|Procedure|Pelvic imaging|Within 60 days prior to the pelvic mass evaluation procedure, each subject must have a pelvic imaging study (e.g. ultrasound, CT scan, MRI, etc.) conducted and read to visualize the pelvic mass according to the current standard of care. Results of the pelvic imaging study(ies) will be recorded.
16013559|NCT02785731|Procedure|Blood draw|Within 60 days prior to, or on the day of the pelvic mass surgery, collect up to 35mL of whole blood into one 5mL SST tube, which must be drawn first, followed by three separate 10mL EDTA tubes.
16013560|NCT02785731|Procedure|laparotomy or laparoscopy|A laparotomy or laparoscopic procedure will be performed by a qualified individual for excision of the pelvic mass. Representative tissue samples will be taken from the excised pelvic mass and evaluated in pathology departments within each institution according to institutional guidelines. Results from the histopathological evaluation will be recorded, including the final diagnosis along with histological sub-type, and if available, stage and grade of cancer where disease is identified.
16013561|NCT02785718|Other|Global Haemostasis assays|
16013562|NCT02785705|Biological|poliovirus vaccine|Different vaccination schedules with bOPV, tOPV and cIPV would be provided for 6 arms respectively.
16013563|NCT02785692|Radiation|Radiation|preoperative Radiotherapy/ IMRT
16013564|NCT02785679|Dietary Supplement|cow's milk formula|addition of cow's milk formula in two different dosage - one only 20ml per day and one group a full meal per day
16013565|NCT02785666|Drug|grazoprevir/elbasvir, ribavirin|To investigate the virological efficacy and safety of grazoprevir/elbasvir ±ribavirin for HIV/HCV-coinfected MSM with a GT 1 and/or 4 infection
16013566|NCT02785666|Behavioral|Behavioural Intervention|To counsel the targeted population with a behavioral intervention regarding the reduction of sexual risk behaviour and recreational drug use.
16013567|NCT02785653|Drug|Sevoflurane|Patients were ventilated with 2 % inspired concentration of sevoflurane in a fresh gas flow of 5 litres containing 66.6% nitrous oxide and 33.3% percent of oxygen
16013568|NCT02785653|Drug|Rocuronium|rocuronium 0.6mg per kg body weight was given intravenously after induction of anaesthesia
16013569|NCT02785640|Behavioral|Hourly prompts to stand delivered by Microsoft Outlook|Prompt group
16013570|NCT02785627|Other|Comprehensive bone health assessment|Blood sample taken for biomarkers of bone turnover, anthropometric measurements, assessments of physical function, DXA scan, HR CT T12 vertebra, Xtreme pQCT radius
16013571|NCT02785614|Drug|trazodone hydrochloride prolonged-release tablet|150 mg, oral administration, 1 per day
16013572|NCT02785614|Drug|trazodone hydrochloride tablet|50mg, oral administration 3 times per day
16013573|NCT02785601|Drug|Trazodone Hydrochloride prolonged-release tablets|strength 75mg, 150 mg. Oral administration with 200ml water
16013574|NCT02785588|Device|3.0 T Neonatal MRI scanner|eligible subjects will undergo neonatal MRI scan procedure
16013575|NCT02785575|Other|HeProCalc algorithm|Heparin and protamine dosage calculated by the algorithm HeProCalc
16013576|NCT02785562|Other|Assessment of PDL1 expression|Intervention : 2 biopsy slides will be analyzed in central laboratory.
16013577|NCT02785549|Drug|Ibuprofen|600 mg/8hours
16013578|NCT02785549|Drug|Acetaminophen|1 g/8 hours
16013579|NCT02785549|Drug|Amoxicillin/clavulanic acid|875mg/125mg/8 hours
16013580|NCT02785536|Behavioral|RITCh Treatment|"The RITCh treatment increased the emphasis on stress management, negative affect management and utilized language and activities to foster an internal locus of control. Activities were added to address impulsive decision-making, develop home smoking policies, increase the positive valance of treatment, and address barriers to use of the nicotine patches. The treatment materials were also tailored with numerous examples relevant to lower SES groups and African Americans. For example: stress management components specifically address financial stress, discrimination, and micro-aggressions; treatment utilization components include reinforcing the value of individual contributions to the group, structured positive feedback among group members at every session, sending missed you post cards signed by all group members to participants who miss a treatment session, specifically addressing myths about nicotine patch use, and practicing the application of nicotine patches together."
16013581|NCT02785536|Behavioral|Standard Treatment|The components of the standard treatment include education and activities in which participants gain an understanding of the biopsychosocial underpinnings of tobacco dependence and the cue-urge-response cycle of smoking. Interventions include self-monitoring, guided scheduled rate reduction, treatment goal setting, medication education, stress management, cognitive and behavioral strategies for managing cravings and cues, problem-solving, conflict management, enhancing social support, relapse prevention, and cigarette refusal training. A participant workbook was provided that corresponded to the activities in the treatment sessions.
16013582|NCT02785523|Drug|Ganoderma Spore Lipids|
16013583|NCT02785523|Drug|Placebo|
16013584|NCT02785523|Drug|Chemotherapy|
16013585|NCT02785497|Other|Control group|will be turn on the equipment, positioning the patient but no put intensity
16013586|NCT02785497|Other|Treatment group|This group will receive electrostimulation
16013587|NCT02785484|Other|Label with constituent disclosure message|Labels with constituent disclosure messages that include text about chemicals in cigarette smoke and health effects of the chemicals will be applied to participants' cigarette packs on the right side (the Surgeon General's warning is on the left side). At the week 2 visit, participants' packs will be labeled with 1 of 3 disclosures selected at random; at the week 3 visit, they will get one of the 2 remaining disclosures selected at random, and at the week 4 visit they will get the remaining disclosure. Study investigators developed the text and design of these labels.
16013588|NCT02785484|Other|Label with litter message|Labels with litter messages that include text about littering cigarette butts will be applied to participants' cigarette packs on the right side (the Surgeon General's warning is on the left side). At the week 2 visit, participants' packs will be labeled with 1 of 3 litter messages selected at random; at the week 3 visit, they will get one of the 2 remaining litter message selected at random, and at the week 4 visit they will get the remaining litter message. Study investigators developed the text and design of these labels.
16013589|NCT02785471|Behavioral|Screening for Mental Health only|Participants in the Screening for Mental Health (SMH)-only group will complete the online depression and suicide screening and receive immediate feedback and referrals.
16013617|NCT02785263|Radiation|2.15 gray and 1.8 gray. Max. 5 weeks.|
16013618|NCT02785250|Other|DPX-Survivac|SubQ injection
16013590|NCT02785471|Behavioral|Screening for Mental Health & Man Therapy|"Participants assigned to Screening for Mental Health, plus Man Therapy (SMH+MT) group will be offered the Man Therapy program in conjunction with Screening for Mental Health. MT provides online early intervention services designed specifically for men who are at risk for suicide and are less likely to engage in help-seeking behavior. MT takes an innovative and humorous approach to mental health education and help seeking through a fictional therapist named Dr. Rich Mahogany, who is a no-nonsense man's man who informs men about the importance of honest talk about life's challenges in addressing their problems. The web portal allows review manly mental health information, facts and tips, explore man therapies, and view videos of men with lived experience."
16013591|NCT02785458|Behavioral|EMC2 Strategy|The intervention includes 1) distribution of simplified one-page medication guide summaries, 2) an automated follow-up call to assess medication safety and problematic side effects and 3) summary reports of call to providers with any concerns flagged for clinic follow-up.
16013592|NCT02785445|Device|Dip.io Home Based Dipstick Analyzer|"First intervention (assigned to the All participants arm)."
16013593|NCT02785445|Device|ACON U500 Mission® U500 Urine Analyzer|"Second intervention (assigned to the All participants arm)."
16013594|NCT02785432|Device|Sham low level laser|Sham laser will be administered using the same time and contact exposure as delivered for the active group, but without any energy delivered.
16013595|NCT02785432|Device|Active low level laser|Active treatment will be delivered using the time, contact, and energy exposures described in the arm description.
16013596|NCT02785419|Behavioral|Arm Training with Action Selection|Treatment occurs in 1.5 hour sessions, 5 times a week for 3 weeks. In each treatment session, you will practice functional tasks with your weaker arm and hand. Additionally, you will be given cues on a computer screen that dictate your movement response (action selection). Practice will be scaled to match your current level of function and progressed over time as able.
16013597|NCT02785406|Drug|suvorexant|Subjects will receive suvorexant capsules (10 mg week 1, 20 mg week 2), once daily at 10 PM.
16013598|NCT02785406|Drug|Placebo (for suvorexant)|Subjects will receive placebo capsules once daily at 10 PM.
16013599|NCT02785393|Drug|Sugar Pill|The administration of a sugar pill
16013600|NCT02785393|Drug|Doxazosin|The administration of the Doxazosin medication
16013601|NCT02785380|Procedure|laparoscopic surgery(LS)|For LS, the patient was usually placed in the lithotomy position. Pneumoperitoneum was maintained at a pressure between 12 and 14 mmHg. Three to 4 working ports sized between 5 mm and 12 mm were used . Intra-operative ultrasonography was performed routinely. Parenchymal transection was performed using a Cavitron ultrasonic surgical aspirator (CUSA, Valleylab, Boulder, CO, USA). Large bile duct branches or vessels were clipped before division and minor hemostasis was carried out using bipolar diathermy. Large hepatic vein branches were divided by endovascular staplers. A 1.0-cm safety margin was planed to get during the liver resection.
16013602|NCT02785380|Procedure|RFA|RFA was performed according to the Guidelines of Radiofrequency Ablation Therapy for Liver Cancer: Chinese Expert Consensus Statement issued by the Chinese Society of Liver Cancer and Chinese Society of Clinical Oncology RFA was performed under real-time ultrasound guidance. RFA was performed by using a commercially available Cool-tipTM RFA system (Valleylab, Boulder, CO, USA), or a RF 2000 system (Radio-Therapeutics Mountain View, CA). Grounding was achieved by attaching 2 pads to the patient's back or legs.
16013603|NCT02785367|Procedure|Cord blood samples|"After delivery, 8 cord blood samples will be taken from the umbilical cord in 8 syringes of about 3 ml, washed with Heparin (Designated syringes exist in the delivery room). 4 syringes will be stored in room temperature. Thermometer will be attached to any sample, and temperature values will be indicated before any measurement.
~The samples will be measured in a gas measurement device, in 4 time points: at the birth, after 15 minutes, after 30 minutes and after 60 minutes from the birth."
16013604|NCT02785341|Other|questionnaires every 6 weeks (T0, T1, T2, T3 and T4)|Questionnaire MFI 20 Questionnaire life satisfaction Scale of measurement of the positive and negative affects Questionnaire QLQ-C30 (EORTC) Questionnaire on the personal goals
16013605|NCT02785341|Other|6-minute walk test) every 6 weeks (T0, T1, T2, T3 and T4)|
16013606|NCT02785341|Other|leptin level with a blood test every 12 weeks (T0, T2 and T4)|blood sample
16013607|NCT02785328|Other|memory evaluation at V1 and V2 (with treatment)|Overnight episodic and procedural memory consolidation performance will be assessed at V1 and V2. The performance will be correlated with sleep data, diurnal neuropsychological assessment and academic performance. The children receive drug treatment (BECTS and Narcolepsy) or surgical (OSA) as part of their routine care.
16013608|NCT02785328|Other|memory evaluation at V1 (without treatment)|Overnight episodic and procedural memory consolidation performance will be assessed at V1. The performance will be correlated with sleep data, diurnal neuropsychological assessment and academic performance.
16013609|NCT02785328|Other|memory evaluation at V1 and V2 (without treatment)|Overnight episodic and procedural memory consolidation performance will be assessed at V1 and V2. The performance will be correlated with sleep data, diurnal neuropsychological assessment and academic performance.
16013610|NCT02785315|Behavioral|rehabilitation & remediation approach|The rehabilitation & remediation approach group will receive 12 weekly 90-minute combined cognition interventions in a group. The first half of each session will be cognitive training which focus on teaching various cognitive strategies to enhance the attention, memory, processing speed, and executive functions. The second half of the session will apply rehabilitation intervention by discussing everyday situations with memory problem and specific strategies related to real-life situations. Investigators will also include one individual session in the 12 group sessions.
16013611|NCT02785315|Behavioral|remediation approach|The remediation approach will receive 12 weekly 90-minute cognitive training which focus on teaching various cognitive strategies and their applications to enhance the attention, memory, processing speed, and executive functions.
16013612|NCT02785289|Device|Vaginal swab|Vaginal cell collection will be performed with the two types of indicated swab.
16013613|NCT02785276|Device|AutoFuser Pain Pump|Closed loop local anaesthetic infusion system
16013614|NCT02785276|Drug|Ropivacaine|Commonly used local anaesthetic drug
16013615|NCT02785276|Other|Normal Saline (0.9%)|Normal saline is a sterile, non-pyrogenic solution for fluid and electrolyte replenishment for intravenous administration. This will be the solution used for the intraperitoneal infusion in the placebo/control group.
16013616|NCT02785263|Radiation|2.15 gray and 1.8 gray. Max. 6 weeks.|
16013619|NCT02785250|Drug|Cyclophosphamide|PO BID
16013620|NCT02785250|Drug|Epacadostat (INCB024360)|PO BID
16013621|NCT02785237|Device|Coroflex® ISAR Drug-eluting stent|Coroflex® ISAR Drug-eluting stent and an Ultimaster® Drug-eluting stent in the second lesion.
16013622|NCT02785237|Device|Ultimaster® Drug-eluting stent|Ultimaster® Drug-eluting stent and a Coroflex® ISAR Drug-eluting stent in the second lesion.
16013623|NCT02785224|Drug|Vasopressin Steroids Epinephrine|Vasopressin Steroids Epinephrine: Vasopressin (up to 5 doses of 20 IU) and methylprednisolone (single dose - 40 mg) in addition to epinephrine during cardiopulmonary resuscitation, and stress dose hydrocortisone (300 mg/day for 7 days maximum followed by gradual taper) for postresuscitation shock.
16013624|NCT02785211|Behavioral|Behavioral Activation Treatment|The modified model will be provided weekly to four groups for intervention, each group including about 10 participants with 1 facilitator for a period of 8 weeks after the baseline survey and general introduction. Each of the 8-week sessions will last for 2 hours. Groups 1 to 4 will have sessions on Mondays, Tuesdays, Wednesdays, and Thursdays respectively; four groups will meet on the same day of the week for all 8 weeks. The scheduling and timing of intervention provide consistency of scheduling for participants.
16013625|NCT02785198|Device|Passive knee extensor machine|The passive training machine, moves both legs from flexion to extension and back, 60 times per minute in 1 hour, 3 times per week. ROM is 60 degrees
16013626|NCT02785185|Drug|IDP-122 Vehicle Lotion|Vehicle
16013627|NCT02785185|Drug|IDP-122 Vehicle Cream|Vehicle
16013628|NCT02785185|Drug|IDP-122 Lotion|Lotion
16013629|NCT02785185|Drug|Ultravate Cream|Cream
16013630|NCT02785172|Drug|IDP-118 Vehicle Lotion|Vehicle
16013631|NCT02785172|Drug|IDP-118 Vehicle Cream|Vehicle
16013632|NCT02785172|Drug|IDP-118 Lotion|Lotion
16013633|NCT02785172|Drug|Ultravate Cream|Cream
16013634|NCT02785159|Drug|IDP-118 Lotion|Lotion
16013635|NCT02785159|Drug|Tazorac Cream|Cream
16013636|NCT02785159|Drug|IDP-118 Vehicle Lotion|Lotion
16013637|NCT02785159|Drug|IDP-118 Vehicle Cream|Cream
16013638|NCT02785146|Drug|Huaier Granule|Huaier Granule is continuously taken three times per day, 20g per time.
16013639|NCT02785146|Drug|Oxaliplatin|85 mg/m², ivdrip, D1
16013640|NCT02785146|Drug|Calcium folinate|Calcium folinate 400 mg/m², ivdrip, D1; or calcium levofolinate, 200 mg/m², ivdrip, D1
16013641|NCT02785146|Drug|5-fluorouracil|400 mg/m², iv, D1; and 2400mg/m², civ, 48h
16013642|NCT02785133|Device|UVL1000 Treatment Station|"Non-coherent light source administered 365 nm, 630 nm, and 530 nm at an output intensity of 0.1 mW directly into an existing intravascular 20 gauge 1.0 catheter"
16013643|NCT02785133|Drug|Normal Saline Solution|150 ml of 0.9% Sodium Chloride Solution
16013644|NCT02785133|Device|Peripheral Catheterization|"20-gauge 1.0 catheter"
16013645|NCT02785120|Drug|TF0023|TF0023 is a new Investigational drug as a topical spray as an anti thrombosis drug, indicated for relief of the signs and symptoms and functional improvement of patients with ischemic strokes.
16013646|NCT02785107|Behavioral|M-PAC Group|Participants attended a workshop, completed a worksheet and received a booster phone call follow-up at week four.
16013647|NCT02785094|Behavioral|Observation|Observation of Participants' behaviour
16013648|NCT02785068|Drug|MM-151|Oligoclonal antibody
16013649|NCT02785068|Drug|nal-IRI|Nanoliposomal irinotecan
16013650|NCT02785068|Drug|Leucovorin|folinic acid
16013651|NCT02785068|Drug|5-FU|Chemotherapy
16013652|NCT02785055|Procedure|Thoracic Epidural Placement|Thoracic Epidural Placement
16013653|NCT02785055|Drug|Bupivacaine 0.05%|Delivery of epidural solution containing both bupivacaine 0.05%/hydromorphone0.01mg/mL solution
16013654|NCT02785055|Drug|Hydromorphone 0.01mg/mL|Delivery of epidural solution containing both bupivacaine 0.05%/hydromorphone0.01mg/mL solution
16013655|NCT02785042|Device|Heidelberg Spectralis OCT|OCT imaging
16013656|NCT02785029|Device|OCT|
16013657|NCT02785003|Drug|Placebo|Individuals enrolled into the control arm of the trial will receive a normal saline placebo infusion at a rate equivalent to the dosage of ketamine in the experimental arm.
16013658|NCT02785003|Drug|Ketamine|All individuals randomized to the experimental arm of the trial will receive ketamine therapy at a rate of 2 mcg/kg/hr dosed based on ideal body weight.
16013659|NCT02785003|Drug|Acetaminophen|All patients admitted to the hospital will be placed on scheduled acetaminophen 1000mg PO q 6 hours unless signs of liver disease/impairment or creatinine clearance < 35ml/min at which point dosage would be reduced to 650mg q 8 hours. Individuals unable to take oral medications would be placed on intravenous acetaminophen.
16013660|NCT02785003|Drug|Opioid|"All individuals will receive as needed opiate therapy as an adjunct to the scheduled medications and ketamine/placebo solution. Choice in opiate therapy will be at the discretion of the attending faculty. Dosage and adjustments will be in accordance with the institutional policy on appropriate opiate dosage adjustment."
16013661|NCT02785003|Drug|Alvimopan|All patients enrolled into the trial will be screened for eligibility for alvimopan utilization. Only in circumstances where patients are not on outpatient opioid medications and where they have not received any at time of arrival will alvimopan be administered. It will be given at least 30 minutes prior to surgery.
16013662|NCT02784990|Biological|Lipase, amylase and CRP (C-reactive protein) dosages|
16013663|NCT02784977|Device|Positive Airway Pressure (PAP)|Treatment of OSA with PAP
16013664|NCT02784977|Device|Intraoral device (IOD)|Treatment of OSA with IOD
16013665|NCT02784977|Procedure|Uvuloplasty|Uvuloplasty
16013666|NCT02784977|Other|Conservative treatment|No active intervention
16013667|NCT02784964|Biological|Elixcyte 8 ml|ADSC 6.4*10^7 cells, allogeneic injection
16013668|NCT02784964|Device|Hya Joint Plus|Hya Joint Plus synovial fluid supplement 3mL, SciVision Biotech Inc.
16013669|NCT02784964|Biological|Elixcyte 4 ml|ADSC 3.2*10^7 cells, allogeneic injection
16013670|NCT02784964|Biological|Elixcyte 2 ml|ADSC 1.6*10^7 cells, allogeneic injection
16013671|NCT02784951|Drug|Red blood cells (0Rh D-neg)|Fresh produced RBC
16013672|NCT02784951|Drug|Whole blood (O Rh D-neg K-neg)|Fresh produced WB
16013673|NCT02784951|Drug|Freeze dried plasma (LyoPlas)|(LyoPlas N-w (German Red Cross)
16073326|NCT02358642|Drug|Placebo|
16013674|NCT02784938|Behavioral|Vocational Empowerment Photovoice (VEP)|The VEP program is a 10-week manualized, structured, peer-led intervention delivered in 2-hour group sessions. The VEP manual includes a Workbook for the clients and a corresponding Leader's Guide for the group peer-leaders. The VEP program integrates Photovoice methodology, Rehabilitation Readiness technology and elements of the Anti-Stigma Photovoice (ASP) curriculum previously developed and tested by the Boston University Center for Psychiatric Rehabilitation (BU CPR). VEP group sessions combine didactic information, Photovoice exercises, and group discussions to empower participants in pursuing employment services and opportunities, all refined with input from individuals with a lived experience.
16013675|NCT02784925|Device|Ultrasound (US) B mode image|"Ultrasound (US) B mode image is an alternative method to measure tissue structure
~and has proven to be an accurate technique to measure subcutaneous fat thickness."
16013676|NCT02784899|Drug|iloprost|"20μg(2ml) of inhaled iloprost (Ventavis®)
~When anesthesia induction finishes, change patients' position from supine to lateral position and measure arterial blood gas analysis (ABGA), venous blood gas analysis (VBGA) while two lung is ventilated. After 20 minutes of applying one lung ventilation, measure ABGA. Apply iloprost or normal saline inhalation for each iloprost and control group and measure ABGA at the time of 20 min and 40 min after iloprost (or normal saline) inhalation has finished."
16013677|NCT02784899|Drug|normal saline|"20μg(2ml) of inhaled normal saline
~When anesthesia induction finishes, change patients' position from supine to lateral position and measure ABGA, VBGA while two lung is ventilated. After 20 minutes of applying one lung ventilation, measure ABGA. Apply iloprost or normal saline inhalation for each iloprost and control group and measure ABGA at the time of 20 min and 40 min after iloprost (or normal saline) inhalation has finished."
16013678|NCT02784886|Biological|Women at high risk of MAP|Blood sample
16013679|NCT02784873|Other|High intensity interval training|High intensity interval training within a standard cardiac rehabilitation programme
16013680|NCT02784860|Drug|Lidocaine|Propofol (0.5 mg/kg or more) is titrated to provide loss of consciousness. Then in the lidocaine group, lidocaine 2% is administered as a bolus followed by a continuous intravenous infusion after loss of consciousness
16013681|NCT02784860|Drug|normal saline|Propofol (0.5 mg/kg or more) is titrated to provide loss of consciousness. Then in the placebo group, the same volume of normal saline is administered after loss of consciousness
16013682|NCT02784847|Drug|Triheptanoin|Triheptanoin oil administered three times per day during meals at a total dose 1mg/kg/day for 3 months
16013683|NCT02784834|Drug|dimethyl fumarate|
16013684|NCT02784821|Drug|Antibiotic|Babies that are assigned to antibiotics receive therapy based on the clinical team's discretion.
16013685|NCT02784821|Other|Gastric fluid|Microbiome, metabolome, and inflammatory mediators will be evaluated using gastric aspirate.
16013686|NCT02784821|Other|Breast milk|Microbiome, metabolome, and inflammatory mediators will be evaluated using mother's breast milk.
16013687|NCT02784821|Other|Stool samples|Microbiome, metabolome, and inflammatory mediators will be evaluated using infant's stool.
16013688|NCT02784821|Drug|Antibiotics - pre-emptive|Babies that are randomized to antibiotics receive therapy based on the clinical team's discretion.
16013689|NCT02784808|Drug|Biological DMARDs|Participants will receive biologic DMARDs as per standard of CARE. The choice of specific biologic DMARD will be at the descretion of treating physician.
16013690|NCT02784808|Drug|Non-Biologic DMARDs|Participants will receive non-biologic DMARDs as per standard of care. The choice of specific non-biologic DMARD will be at the descretion of treating physician.
16013691|NCT02784795|Drug|LY3039478|Administered orally
16013692|NCT02784795|Drug|Taladegib|Administered orally
16013693|NCT02784795|Drug|Abemaciclib|Administered orally
16013694|NCT02784795|Drug|Cisplatin|Administered IV
16013695|NCT02784795|Drug|Gemcitabine|Administered IV
16013696|NCT02784795|Drug|Carboplatin|Administered IV
16013697|NCT02784795|Drug|LY3023414|Administered orally
16013698|NCT02784782|Device|Orthesis|
16013699|NCT02784782|Behavioral|No orthesis|
16013700|NCT02784769|Other|measurement of skin autofluorescence|
16013701|NCT02784769|Other|skin biopsy collection|
16013702|NCT02784756|Device|Quantiferon-CMV assay|
16013703|NCT02784743|Drug|''albendazole'' and ''ivermectin''|annual single dose administration of albendazole 400mg and ivermectin 150ug/kg of weight (according to the height)
16013704|NCT02784730|Procedure|Iterative PICC placement|Intervention is the catheterisation strategy (not the device)
16013705|NCT02784730|Procedure|Long term PAC placement|Intervention is the catheterisation strategy (not the device)
16013706|NCT02784717|Drug|Rivaroxaban (Xarelto, BAY 59-7939)|Decision regarding dose and duration of treatment made at the discretion of the attending investigator.
16013707|NCT02784704|Drug|Eravacycline|
16013708|NCT02784704|Drug|Meropenem|
16013709|NCT02784704|Drug|Placebo|
16013710|NCT02784691|Device|Feeligreen patch|
16013711|NCT02784678|Procedure|closed reduction group|Patients in the experimental group will undergo C-arm fluoroscopy-assisted minimally invasive closed reduction and internal fixation with fully threaded headless cannulated compression screws. In the experimental group, fractures will be reduced and internally fixed with fully threaded headless cannulated compression screws of appropriate lengths (Acutrak plus; Acumed Inc., Beaverton, OR, USA) under C-arm fluoroscopic guidance to restore the radial inclination and ulnar deviation of the distal radius.
16013712|NCT02784678|Device|open reduction group|Patients in the control group will undergo open reduction and internal fixation with a titanium plate (Ningbo Cibei Medical Treatment Appliance Co., Ltd., Ningbo, China).
16013713|NCT02784665|Device|577-MPL|All treatments were provided by a single practitioner with the 577-nm yellow laser system(Supra 577nm affected area in micropulse model.The power titration was started at 700 milliwatt(mW) and then gradually increased until a just visible burn was seen. When this threshold was reached, the power was reduced by 50%, using a 100-μm spot diameter and a 200-ms duration with 5 % duty cycle LaserSystem) in 577-MPL arm. The individual power for the patient was titrated at a normal area of near the
16013714|NCT02784665|Device|577-TL|"All treatments were provided by a single practitioner with the 577-nm yellow laser system(Supra 577nm LaserSystem) in 577-TL arm.
~100 microns light spot size, 0.05 seconds duration, 80 ~ 200 milliwatts of power"
16014370|NCT02779751|Drug|Abemaciclib|Administered orally
16013715|NCT02784652|Drug|Zoledronic acid|Zoledronic acid: every 4 weeks, 6 times, 4.0 mg iv
16013716|NCT02784652|Radiation|Radiotherapy|Radiotherapy: 5 days/ week, 3 Gy * 10-13 fractions or 4 Gy * 5 fractions,
16013717|NCT02784639|Other|Plasma Analysis of circulating cell free DNA|
16013718|NCT02784639|Other|Tumor tissue analysis of circulating cell free DNA|
16013719|NCT02784626|Drug|Dexmedetomidine|Intraoperative sedation using dexmedetomidine
16013720|NCT02784626|Drug|Propofol|Intraoperative sedation using propofol
16013721|NCT02784613|Drug|Ospemifene|FDA approved medication for the treatment of vulvovaginal atrophy and dyspareunia
16013723|NCT02784587|Procedure|Stellate Ganglion Block|After induction of general anesthesia, patients will receive a stellate ganglion block using a standard and well described paratracheal technique, which typically requires about 3 minutes to perform. The patient's head will be extended and a 4-5-cm, 22-gauge needle inserted at the medial edge of the sternocleidomastoid muscle just below the level of the cricoid cartilage at the level of the transverse process of C6 (Chassaignac's tubercle) or C7 (3-5 cm above the clavicle). The non-operative hand will retract the muscle together with the carotid sheath prior to needle insertion. After advancing to the transverse process the needle will be withdrawn 2-3 mm prior to injection. A negative aspiration test will be performed in two planes before a 1-ml test dose is used to exclude unintentional intravascular injection (vertebral or subclavian arteries) or subarachnoid injection into the dural sleeve.4 A total of 10 ml of 0.25% bupivacaine will be injected.
16013724|NCT02784561|Drug|Busulfan (Zhejiang Otsuka Pharmaceutical Co. Ltd)|busulfan (3.2 mg/kg/day intravenously [i.v.], days -10 to -8)
16013725|NCT02784561|Drug|Cytarabine(Actavis Italy S.p.A)|cytarabine (1.6 g/m2/day, days -7 to -3)
16013726|NCT02784561|Drug|Fludarabine (Bayer)|fludarabine (30 mg/m2, day -7 to -3),
16013727|NCT02784561|Drug|granulocyte colony-stimulating factor (KirinKunpeng)|granulocyte colony-stimulating factor (5 ug/kg, day -8 to granulocyte recovery)
16013728|NCT02784561|Drug|rabbit ATG（Sanofi/Genzyme）|ATG; thymoglobuline, rabbit;2.5 mg/kg/day, days -5 to -2
16013729|NCT02784548|Other|Virtual Reality|Using a VR headset, motion sensors, and VR software, the investigators will create a customized VR treatment for each participant that engages them in movements and exercises involving their missing limb in a game-like environment. For example, participants may use the headset to engage in activities such as driving a race car around a course requiring both arms, ski down simulated slopes, or manipulate objects.
16013730|NCT02784535|Drug|Atomoxetine|norepinephrine transporter inhibitor
16013731|NCT02784535|Drug|Placebo|placebo
16013732|NCT02784522|Device|locking compression plate group|Closed reduction via shoulder lateral approach followed by locking compression plate fixation using minimally invasive technique
16013733|NCT02784522|Device|conventional locking plate group|Closed reduction via shoulder lateral approach followed by conventional locking plate fixation using minimally invasive technique
16013734|NCT02784496|Other|Long-term Follow-up|Undergo follow-up assessment
16013735|NCT02784496|Other|Quality-of-Life Assessment|Ancillary studies
16013736|NCT02784496|Drug|Ruxolitinib|Given PO
16013737|NCT02784483|Drug|Atezolizumab (1200mg via IV infusion)|Patients will get atezolizumab every 21 days for up to 1 year
16013738|NCT02784470|Device|gastroduodenal stent placement|
16013739|NCT02784470|Procedure|gastrojejunostomy|
16013740|NCT02784457|Drug|Cetrorelix|
16013741|NCT02784444|Drug|MSDC-0602K|MSDC-0602K capsules
16013742|NCT02784444|Drug|Placebo|Placebo capsules
16013743|NCT02784431|Device|Contour Neurovascular System placement|Patients who meet the eligibility criteria will have their target aneurysm treated with the Contour Neurovascular System device via standard endovascular procedure.
16013744|NCT02784418|Procedure|Chronic Total Occlusion Percutaneous Coronary Intervention|Chronic Total Occlusion Percutaneous Coronary Intervention (CTO PCI), as per standard clinical practice
16013745|NCT02784418|Procedure|Sham Procedure|Sham Procedure: Bilateral arterial access, without angiography or PCI being performed
16013746|NCT02784392|Drug|Ulimorelin|Active
16013747|NCT02784392|Drug|Metoclopramide|Comparator
16013748|NCT02784353|Behavioral|Perioperative rehabilitation program|"Perioperative rehabilitation program
~preoperative rehabilitation : 2 weeks prior to operation
~postoperative rehabilitation : 3 months after operation"
16013749|NCT02784353|Behavioral|Conventional|conventional perioperative management without rehabilitation program
16013750|NCT02784340|Drug|Dexamethasone|16 mg Dexamethasone IV drip
16013751|NCT02784340|Drug|Dexamethasone|16 mg Dexamethasone subcutaneous injection around the caesarean section scar after skin closure
16013752|NCT02784340|Drug|Saline (IV fluids)|IV fluids 500 cc saline infusion
16013753|NCT02784340|Drug|Bupivicaine and Fentany|
16013754|NCT02784340|Device|25G spinal needles|
16013755|NCT02784327|Drug|PRF110|
16013756|NCT02784314|Procedure|Robotic-Assisted Radical Prostatectomy|
16013757|NCT02784314|Procedure|Laparoscopic Radical Prostatectomy|
16013758|NCT02784301|Device|Belly breathing with biofeedback app|This intervention consists of learning how to belly breathe using a smartphone biofeedback application that coaches children how to breathe slowly and deeply. The app consists of a cartoon avatar in a hot air balloon that inhales and exhales bubbles. The goal of the biofeedback game is to a) teach a voluntary deep breathing protocol, b) detect compliance to the breathing protocol using the attached audio-based pulse oximeter sensor and c) to raise the hot air balloon in accordance to this compliance in order to motivate the children. Scenery changes as the balloon rises, driven by biofeedback, until it eventually reaches outer space.
16013759|NCT02784301|Behavioral|Belly breathing without biofeedback app|This intervention consists of learning how to belly breathe without the biofeedback application prior to the blood collection and continuing with self-directed belly breathing during the procedure itself.
16013854|NCT02783729|Drug|Zolpidem tartrate|Zolpidem tartrate extended release 6.25 mg will be administered orally in tablet form at home each night, immediately before the time the participant intends to try to sleep.
16013855|NCT02783729|Drug|Zolpidem-matched placebo|Zolpidem-matched placebo will be administered orally in tablet form at home each night, immediately before the time the participant intends to try to sleep.
16074980|NCT02346175|Drug|SHR3824|
16013760|NCT02784301|Behavioral|Belly breathing + visual distraction|This intervention consists of learning how to belly breathe without the application plus receiving visual distraction by watching a cartoon avatar in the hot air balloon rising through space. The avatar will not coach the child to breathe as the visual cues for breathing (words and bubbles) will not be present and the avatar will not rise in response to correct belly breathing. Participants will be instructed to continue with self-directed breathing while also watching the visual distraction during the blood collection procedure.
16013766|NCT02784275|Drug|Cyclo-Z|
16013767|NCT02784275|Drug|Placebo|
16013768|NCT02784262|Drug|botox injection Multiguide|botox injection under CT/MR navigation and with the navigation tool MultiGuide
16013769|NCT02784249|Procedure|Goniotomy|Procedure: Goniotomy and trabecular excision with a novel ophthalmic knife in combination with planned cataract extraction via Phaco and PCIOL implant.
16013770|NCT02784249|Device|Trabecular Micro-Bypass Stent|Procedure: Trabecular Micro-Bypass stent implantation in combination with planned cataract extraction via Phaco and PCIOL implant.
16013771|NCT02784249|Procedure|Cataract Extraction|Cataract extraction via Phaco and PCIOL implant.
16013772|NCT02784236|Device|telemedicine|The study population corresponds to patients> 18 and <65 years with DM1 of> 1 year of evolution, and treated with MDI HbA1c> 7%. It is changing one group of subjects between two observation times due to any intervention in this case the addition of a tele
16013773|NCT02784223|Device|Radiation : PET-CT with F18-choline examination|PET-CT with F18-choline examination will be performed before surgery
16013776|NCT02784197|Device|Phase Signal Recorder|The cPSTA System is a medical device system that uses passive tomography to analyze a patient's phase space data to identify the presence of significant coronary artery disease. The cPSTA System consists of several components that work together to obtain, transmit, analyze the data, and display the results, including the Phase Signal Acquisition System (PSAQ System), which is the Phase Signal Recorder (PSR) and the Phase Signal Data Repository (PSDR); analytical software; and secure web portal. For this study only the PSAQ System is used by the clinical site for the purposes of acquiring and transmitting the signal.
16013777|NCT02784171|Drug|Cisplatin|
16013778|NCT02784171|Drug|Pemetrexed|
16013779|NCT02784171|Drug|Pembrolizumab|
16013780|NCT02784158|Drug|Brigatinib|Brigatinib will be administered orally to eligible patients with locally advanced or metastatic ALK+ NSCLC who are resistant or intolerant to a prior ALK inhibitor at a dose of 180 mg QD with a 7 day lead-in at 90 mg QD, continuously, with or without food.
16013781|NCT02784145|Dietary Supplement|Resistant starch|
16013782|NCT02784145|Other|Recommendation with regard to nutrition|Subjects in this arm will receive General recommendations with regard to nutrition based on the guidlines of the German Society for nutrition
16013783|NCT02784132|Other|Video diversion|The intervention is playing a video on a computer or iPad (using www.youtube.com) while performing fundoscopy.
16013784|NCT02784119|Procedure|temporary porto-caval shunt|temporary porto-caval shunt
16013785|NCT02784106|Drug|Placebo|Participants received placebo matched to M2951 twice daily up to Day 84 during the double-blind treatment period.
16013786|NCT02784106|Drug|M2951|Participants received 50 milligrams (mg) M2951 orally twice daily up to Day 84 during the double-blind treatment period.
16013787|NCT02784106|Drug|M2951|Participants who received placebo matched to M2951 or M2951 in double-blind treatment period, received 50 mg M2951 orally twice daily up to 26-weeks during the open label extension period.
16013788|NCT02784093|Drug|Gastrograﬁn|
16013789|NCT02784093|Procedure|enemas|
16013790|NCT02784080|Other|HLA-alloantibodies exposure|"Following analyzes will be done:
~LABScreen® Mixed, One Lambda, CA LABScreen® Single Antigen, One Lambda, CA C1qScren™, One Lambda, CA PE-conjugated IgG3 antibody"
16013791|NCT02784067|Drug|Sucraid|Study drug
16013792|NCT02784067|Drug|Placebo|Sucraid placebo
16013793|NCT02784054|Drug|Carboplatin|
16013794|NCT02784054|Drug|Etoposide|
16013795|NCT02784054|Drug|Cyclophosphamide|
16013796|NCT02784054|Drug|Bleomycin|
16013797|NCT02784054|Drug|Thiotepa|
16013798|NCT02784054|Drug|Melphalan|
16013799|NCT02784054|Radiation|Reduced dose radiotherapy|
16013800|NCT02784041|Drug|single adductor-canal-block|Single adductor-canal-block is performed before the surgery. A 12Hz linear ultrasound transducer is placed on the medial part of the thigh with the leg slightly externally rotated. The femoral artery was identified in short axis in the adductor canal, underneath the sartorius muscle. After skin disinfection , an 18-gauge needle (B.Braun Medical, Melsungen, Germany) is inserted in-plane from the lateral side of the transducer. The needle tip was placed underneath the sartorius muscle, just lateral to the artery and saphenous nerve, using 2-3 ml of saline to ensure correct placement. 25 ml of 0.35% ropivacaine is slowly injected with repeated aspiration.
16013987|NCT02782676|Device|Healon5 OVD|ophthalmic viscosurgical device
16013988|NCT02782663|Drug|ABT-494|Tablet: Oral
16014032|NCT02782351|Biological|CAR-T|Patients will be infused with autologous CAR-T infusion in a dose escalating manner.
16074981|NCT02346175|Drug|Placebo|
16013801|NCT02784041|Drug|periarticular infiltration|The periarticular infiltration of multimodal agents will involve the preparation of a mixture of 100 ml solution. The mixture contains 30ml (300mg) ropivacaine, 0.5ml (5 mg) morphine, 2 ml (50 mg) flurbiprofen and 0.5 ml of 1:1000 epinephrine, and then is diluted with 0.9% normal saline to a total volume of 100ml. 50 ml of mixture will be injected into the anterior, medial and lateral soft tissues after the implantation of the joint prostheses. The remaining 50 ml of mixture will be injected into intraarticular space after the closure of articular capsule.
16013802|NCT02784028|Other|SGM-101|Administration of SGM-101 prior surgery
16013803|NCT02784015|Drug|Cisplatin|
16013804|NCT02784015|Drug|Etoposide|
16013805|NCT02784015|Drug|Doxorubicin|
16013806|NCT02784015|Drug|Cyclophosphamide|
16013807|NCT02784015|Drug|Ifosfamide|
16013808|NCT02784015|Drug|Carboplatin|
16013809|NCT02784015|Radiation|Radiotherapy|
16013810|NCT02784015|Drug|Thiotepa|
16013811|NCT02784015|Drug|Melphalan|
16013812|NCT02784002|Drug|Ridinilazole|
16013813|NCT02784002|Drug|Fidaxomicin|
16013814|NCT02783989|Other|white wine|A dietary beverage: a market white wine, 13º alcohol
16013815|NCT02783989|Dietary Supplement|tyrosol|tyrosol in capsules
16013816|NCT02783976|Drug|Sovaldi|Sovaldi 400 mg tablets administered orally once daily
16013817|NCT02783963|Device|OCT and CMR imaging|"OCT: Imaging for the presence and vulnerability of coronary plaque as well as plaque disruption.
~CMR: Imaging for identification of myocardial injury (late gadolinium enhancement and myocardial edema) as well as other concomitant findings."
16013818|NCT02783950|Other|Decipher Prostate Cancer Classifier|The Decipher test (GenomeDx Biosciences, San Diego, CA) is a genomic test that predicts high grade disease, the probability of metastasis and prostate cancer-specific mortality for men with prostate cancer.
16013819|NCT02783937|Biological|Filgrastim|"Each case will have two intervention phases done blindly at random with a wash-out period of 6 months:
~Phase A:
~Filgrastim vial (30 million IU/ml) SC injection twice daily for five consecutive days.
~Phase B:
~Injection of saline SC injection twice daily for five consecutive days."
16013820|NCT02783937|Drug|Saline|Injection of saline SC injection twice daily for five consecutive days
16013821|NCT02783924|Drug|Cholecalciferol|Vitamin D preparation
16013822|NCT02783924|Drug|Placebo|placebo
16013823|NCT02783911|Device|MTA|Mineral Trioxide Aggregate grey paste
16013824|NCT02783911|Drug|Ferric Sulfate|Ferric Sulfate paste
16013825|NCT02783898|Device|AliveCor Heart Monitor|Smart phone based ECG event recorder
16013826|NCT02783885|Drug|immunotherapy|
16013827|NCT02783859|Drug|Amoxicillin-clavulanic Acid|
16013828|NCT02783859|Drug|Placebo (for Amoxicillin-clavulanic Acid)|
16013829|NCT02783846|Other|normal saline|receive equal volume of normal saline
16013830|NCT02783846|Drug|dexmedetomidine 0.5 µg/kg|receive dexmedetomidine 0.5 µg/kg
16013831|NCT02783846|Drug|dexmedetomidine 1.0 µg/kg|receive dexmedetomidine 1.0 µg/kg
16013832|NCT02783833|Drug|MMV390048 40mg|
16013833|NCT02783833|Drug|MMV390048 dose to be determined mg|Cohort 2 will receive a single dose of MMV390048. Depending on the data obtained from the 40mg cohort, the dose in Cohort 2 will be determined.
16013834|NCT02783820|Drug|MMV390048 40 mg|
16013835|NCT02783820|Drug|Placebo to match MMV390048 40 mg|
16013836|NCT02783820|Drug|MMV390048 80 mg|
16013837|NCT02783820|Drug|Placebo to match MMV390048 80 mg|
16013838|NCT02783820|Drug|MMV390048 120 mg|
16013839|NCT02783820|Drug|Placebo to match MMV390048 120 mg|
16013840|NCT02783807|Device|Eyenez Retinal Camera v200|
16013841|NCT02783807|Device|Volk Pictor Ret 1|
16013842|NCT02783794|Drug|BP-C1|BP-C1, 0.05% solution for injection; doses: 0.035 mg/kg body weight (0.07 mL/kg) intramuscularly once daily for 32 consecutive days
16013843|NCT02783794|Drug|Placebo|Placebo, solution for injection; doses: 0.07 mL/kg body weight intramuscularly once daily for 32 consecutive days
16013844|NCT02783781|Procedure|Cardiac surgery (extracorporeal circulation; beating heart)|"Patient's usual care as part of cardiac surgery, analysis of biological data collected at the time of arrival of the patient in the operating room.
~Blood sample collection Urine sample collection"
16013845|NCT02783768|Device|E-cigarette|The study e-cigarette exposure will be 10 puffs with 30-second inter-puff intervals, as directly observed by a trained research assistant, using a standardized e-cigarette. Cartomizers, batteries, and e-liquids will be obtained from commercial suppliers. The e-cigarette device will be loaded with 1 mL of flavorless e-liquid with a ratio of PG to vegetable glycerin of 70:30 and 1.8 mg/dL of nicotine.
16013846|NCT02783768|Other|Sham|"The unexposed condition will be breathing from the study e-cigarette (10 puffs with 30-second inter-puff intervals) with the battery off."
16013847|NCT02783768|Drug|Hyperpolarized 3-Helium|Hyperpolarized 3-Helium will be used as an experimental contrast agent for the Ventilation MRIs performed twice per participant in both experimental arms. Approximately 250-600 mL of hyperpolarized 3He mixed with 300-750 mL nitrogen will be inhaled through a one-way valve in one inhalation starting approximately at residual volume.
16013848|NCT02783768|Drug|Gadolinium|Gadolinium contrast will be injected into the antecubital vein through an 18-20 gauge IV. The type of gadolinium will be 0.03 mmol/kg bodyweight of dotarem (gadoterate meglumine).
16013849|NCT02783755|Behavioral|Device: smartphone|Coping Skills Training for pain will be delivered to participants using video-conferencing
16013850|NCT02783742|Behavioral|Communication coaching|Study coaches will conduct tailored individual sessions with participating providers to teach and improve communication techniques. Coaches will then shadow or audio-record patient encounters and deliver feedback to providers on their communication during these encounters.
16013851|NCT02783729|Drug|Lemborexant|Lemborexant 5 mg will be administered orally in tablet form at home each night, immediately before the time the participant intends to try to sleep.
16013852|NCT02783729|Drug|Lemborexant|Lemborexant 10 mg will be administered orally in tablet form at home each night, immediately before the time the participant intends to try to sleep.
16013853|NCT02783729|Drug|Lemborexant-matched placebo|Lemborexant-matched placebo be administered orally in tablet form at home each night, immediately before the time the participant intends to try to sleep.
16077232|NCT02330120|Drug|propofol|
16013856|NCT02783716|Device|Cardiac Resynchronization Therapy Implantation|An implanted cardiac resynchronization device is a medical device used in cardiac resynchronization therapy (CRT). It resynchronizes the contractions of the heart's ventricles by sending tiny electrical impulses to the heart muscle, which can help the heart pump blood throughout the body more efficiently.
16013857|NCT02783716|Device|Implantable Cardioverter-defibrillator (ICD)|An implantable cardioverter-defibrillator (ICD) - a pager-sized device - is placed in the chest to reduce risk of dying if the lower chambers of the heart (ventricles) go into a dangerous rhythm and stop beating effectively
16013858|NCT02783703|Dietary Supplement|Medium chain triglycerides (MCT)|Subjects will consume 30 grams per 2000 kilocalories daily of medium chain triglyceride oil by mouth
16013859|NCT02783690|Radiation|Hypofractionation|40 Gy (RBE) in 15 daily fractions
16013860|NCT02783677|Procedure|Percutaneous balloon angioplasty|
16013861|NCT02783664|Other|Questionnaires to Evaluate Anxiety Related to Genetic Testing|"A health team member will outline the study parameters to the patient prior to the genetic counseling visit.
~Visit 1: At the genetic counseling appointment (prior to counseling) patients will receive the following: the State-Trait Anxiety Inventory (STAI) for Adults) to measure baseline anxiety, the Health Anxiety Inventory (HAI) to measure baseline health anxiety, the modified Cancer Worry Scale (CWS) to measure baseline cancer worry in addition to some additional questions about the patient's background. The patient will complete the questionnaires privately and then return them to the genetic counselor.
~Follow-up: One week following disclosure of genetic testing results (3 weeks after the initial appointment), a research team member will call the patient and administer the HAI and CWS over the phone. This will be repeated at 5 weeks, 3 months, and 6 months after initial visit.
~Time to take initial surveys: 15-20 minutes total. Follow-up calls: 10-15 minutes total."
16013862|NCT02783651|Other|Other|No intervention other than routine medical care
16013863|NCT02783638|Drug|YHD1119|2 by 2
16013864|NCT02783638|Drug|Lyrica|2 by 2
16013865|NCT02783625|Drug|Romidepsin|
16013866|NCT02783625|Drug|Bortezomib|
16013867|NCT02783625|Drug|duvelisib|
16013868|NCT02783612|Other|glucose buddy application|
16013869|NCT02783599|Drug|Olaratumab|Administered IV
16013870|NCT02783599|Drug|Doxorubicin|Administered IV
16013871|NCT02783599|Radiation|External Beam Radiotherapy|
16013872|NCT02783586|Procedure|Quadratus Lumborum Block type II|Local anaesthetic injection on the posterior border of the quadratus lumborum muscle
16013873|NCT02783586|Procedure|Transversus Abdominalis Plane Block|Local anaesthetic injection between internal oblique and transversus abdominis muscle
16013874|NCT02783586|Drug|Bupivacaine|20 ml of bupivacaine with adrenaline
16013875|NCT02783586|Device|Ultraplex|A non-stimulating echogenic single-shot needle designed for regional analgesia under ultrasound guidance.
16013876|NCT02783573|Drug|Lanabecestat|Administered orally
16013877|NCT02783573|Drug|Placebo|Administered orally
16013878|NCT02783560|Behavioral|The Sleep Train Program|This modular behavioral sleep intervention includes required modules on sleep routines and sleep habits, and optional modules on bedtime problems, fears, anxiety, and independent sleep.
16013879|NCT02783560|Behavioral|The Family Mealtimes Program|This modular behavioral mealtime intervention includes required modules on mealtime routines and healthy mealtime habits, and optional modules on picky eating and mealtime behavior difficulties.
16013880|NCT02783547|Drug|SyB C-1101 and Azacytidine|"This study is a multi-center open-label study to assess the tolerability of oral administration of SyB C-1101 twice daily from Day 1 to Day 21 in combination with subcutaneous administration or intravenous drip infusion of azacitidine once daily at a dose of 75 mg/m2 (body surface) for 7 days during the period between Day 8 and Day 16, and to estimate the recommended dose (RD) of C-1101.
~SyB C-1101 will be administered at a daily dose of 560 mg or 840 mg in each of the 2 cohorts for a treatment period of 1 cycle for 28 days, including 21 days for SyB C-1101 treatment followed by 7 days of follow-up."
16013881|NCT02783534|Device|Verum acupuncture|"Participants allocated to VA group will receive traditional acupuncture treatment on the Guanyuan(RN 4), bilateral Sanyinjiao(SP 6), bilateral Zigong(EX-CA1), bilateral Xuehai(SP 10). Additional points will be chosen according to TCM syndrome differentiation constitution of patients. If patients with deficient syndrome, bilateral Zusanli (ST 36) will be included. If patients with sufficiency syndrome, bilateral Diji (SP 8) will be included. The NO.16 special type of acupuncture needle (0.30 x 30 mm) produced by German asia-med company will be applied.The needles will be inserted into the skin of acupuncture points and manipulated manually by using the techniques such as lifting, thrusting, and twirling, until the internal compound sensation known as deqi."
16013882|NCT02783534|Device|Sham acupuncture|We use a non-insertive sham control produced by Asia-med Company in Germany-the streitberger placebo-needle. Sham points are described as follows: 1) 5 inch lateral to the seventh thoracic spine; 2) 5 inch lateral to the eighth thoracic spine; 3) 5 inch lateral to the ninth thoracic spine; and 4) 5 inch lateral to the tenth thoracic spine.
16013883|NCT02783534|Behavioral|Usual care|Patients in usual care group will not receive acupuncture treatment but enhance usual care by providing them with detailed information via propaganda booklets or the internet in the form of health education.
16013884|NCT02783521|Behavioral|Counseling sessions|During the first 12 weeks, intervention participants will attend weekly 30-45-minute individual counseling sessions guided by a trained bilingual Hispanic male lifestyle coach. Counseling sessions will be tailored to the needs of the participants (e.g., evening/weekend sessions, waiting/childcare area). After 12 weeks, intervention group participants will receive bi-weekly phone calls across a 12-week follow-up. Phone calls will last approximately 10 minutes in duration and study staff will follow a script to review current body weight, eating and activity behaviors, and specific barriers for weight loss/maintenance or diet/physical activity behaviors.
16013885|NCT02783521|Behavioral|Wait List Control|After 12 weeks, the wait list control will receive the weight loss intervention plus mHealth technology support. It will include tailored, targeted text messaging and real-time self-monitoring support including beverage tracking cups, which provide the amount of calories users are consuming through beverages on a daily basis, and wearable activity monitors.Behavioral constructs used for the intervention group will be maintained during this intervention delivery thereby ensuring all participants have the appropriate tools to continue weight loss efforts regardless of mHealth use.
16014033|NCT02782338|Drug|Voltaren ophtha 0.1%|All study patients will be treated with Voltaren ophtha 0.1% after cataract surgery
16013886|NCT02783508|Drug|IV Meperidine|"Intravenous meperidine 50mg in 100cc NaCl 0.9% . Repeated doses (if needed): intervals of 2 hours minimum until a maximum of 4 doses.
~In cases of nausea or vomiting intravenous metoclopramide 10mg will be offered to the parturient.
~If pain intensity (according to visual analogue scale), 20 to 30 minutes from administration, will not decline or the parturient will ask for a different type of analgesia, inhaled nitrous oxide or epidural analgesia will be offered."
16013887|NCT02783508|Drug|Nitrous Oxide|"Nitrous oxide in a 50/50 mix with oxygen given via self-administered face mask. The parturient will be advised to place the mask tightly on her face and to breathe through it at the first sign of forthcoming uterine contraction. Between contractions, she will be advised not to breathe through the mask.
~In cases of nausea or vomiting intravenous metoclopramide 10mg will be offered to the parturient.
~If pain intensity (according to visual analogue scale), 20 to 30 minutes from administration, will not decline or the parturient will ask for a different type of analgesia, intravenous meperidine or epidural analgesia will be offered."
16013888|NCT02783495|Behavioral|Device: iPad|All patients will receive baseline neurocognitive and quality of life testing, followed by 3 months of the iPad-based intervention. At the end of the baseline visit, subjects will be lent an iPad to take home (or will be assisted in the installation of the ReMind app on their personal iPad) and instructed in the use of the ReMind app (and more basic iPad skills, if necessary). Subjects will review the intervention schedule (approximately 3 hours per week). Testing will be repeated 3 months after the baseline visit (i.e., immediately after the intervention) and 9 months after the baseline visit (i.e., 6 months after completion of the intervention), both time-points including a new MRI.
16013889|NCT02783482|Biological|GC5107|GC5107 20g/200mL, intravenously, dose of 300 - 900 mg/kg (of body weight) every 21 or 28 days for 12 months, a follow-up (3 or 4 weeks)
16013890|NCT02783469|Genetic|Identification of genetic causes of diabetic neuropathic pain|
16013891|NCT02783456|Procedure|Noise|The patient is exposed 30 min to the first sound pattern and during the renal hemodynamics will be measured. The following is a 1-hour break.
16013892|NCT02783456|Procedure|Silence|The patient is exposed 30 min to the second sound pattern and during the renal hemodynamics will be measured.
16013893|NCT02783443|Other|General anesthesia|General anesthesia
16013894|NCT02783443|Other|Regional anesthesia|Regional anesthesia
16013895|NCT02783430|Drug|Ketamine|One single perfusion of 0.5 mg/kg during 40 minutes at the beginning of the inclusion
16013896|NCT02783430|Drug|Milnacipran|One or two caps per day from the beginning of the inclusion. Milnacipran dosage depending of glomerular filtration rate of patient, during 16 days (doses of 25 or 50 mg or 100mg per day)
16013897|NCT02783430|Drug|Placebo|One single perfusion during 40 minutes at the beginning of the inclusion
16013898|NCT02783417|Other|Strength Training|"G1: will be three series of repetitions to the concentric failure with occlusion pressure, with the two-second intervals for the concentric phase and two seconds for the eccentric phase (Moore et al., 2004;. LAURENTINO et al, 2012), with 30% of 1RM and intermittent vascular occlusion members. Will be provided one-minute intervals between sets and exercises (with the exception of the interval between the exercises of upper and lower; being provided at present a three-minute break for removal and installation of restrictive cuffs).
~G2: will be three series of repetitions to the concentric failure, with cadence of movement and intervals similar to the G1. The intensity will be 80% of 1RM without occlusion."
16013899|NCT02783404|Drug|Amoxicillin|Receiving 2 gr oral Amoxicillin before dental any manipulation and following endotracheal intubation
16013900|NCT02783404|Drug|Amoxicillin-Potassium Clavulanate|"Receiving 2 gr/125 mg oral Amoxicillin-Potassium Clavulanate before any dental manipulation and following endotracheal intubation
~Intervention: Drug: Amoxicillin-Potassium Clavulanate"
16013901|NCT02783391|Device|ECoG and intracortical electrodes|
16013902|NCT02783378|Drug|Gaviscon Syrup|
16013903|NCT02783365|Behavioral|Photo-elicitation and online group support|See above information.
16013904|NCT02783352|Procedure|arthroscopic rotator cuff repair|arthroscopic rotator cuff repair
16013905|NCT02783352|Procedure|autologous micro-fragmented adipose tissue|injection of autologous micro-fragmented adipose tissue (10 mL) after arthroscopic rotator cuff repair, in dry arthroscopy condition
16013906|NCT02783326|Other|Rehabilitation|Pulmonary rehabilitation, exercise in COPD individuals and health individuals
16013907|NCT02783313|Device|Pathogen reduced plasma-stored platelet concentrates|Platelet concentrates treated with the Mirasol PRT system (pathogen reduction technology) and stored in plasma.
16013908|NCT02783313|Other|Plasma-stored platelet concentrates|Platelet concentrates stored in plasma
16013909|NCT02783300|Drug|GSK3326595|GSK3326595 will be administered with and without food, in tablet and capsule formulation.
16013910|NCT02783300|Drug|Pembrolizumab|Pembrolizumab will be administered.
16013911|NCT02783287|Behavioral|Text message reminder for medication adherence|Patients randomized to this arm receive one text message per day (at the scheduled time) reminding them to take their medication.
16013912|NCT02783287|Behavioral|Text message reminder for exercise regimen|Patients randomized to this arm receive 4 daily text messages reminding them to exercise for 30 minutes per day.
16013913|NCT02783274|Device|Actis Total Hip System|Total Hip Replacement and Hemi-hip Replacement
16013914|NCT02783261|Other|CT volumetric measurement after Y90 radioembolization|Liver volume will be measure at 3 time points. All patients will undergo CT volumetry at baseline, 4-6 weeks and 8-12 weeks after SIRT. The images are then measured using a commercially available 3D software (Vital's Vitrea Advanced CT Liver Oncology package) and manually corrected, reviewed and resected by a single senior radiologist to ensure consistency in following the same anatomical landmarks.
16013915|NCT02783235|Other|cervical cancer screening|for 50 ANMs/ASHAs/PHWs/ in conducting cervical cancer related health education , screening for cervical cancers using VIA, collection of PAP smears and HPV samples.
16013916|NCT02783222|Drug|Nab-paclitaxel|comparison of different dosages of drug
16013917|NCT02783209|Procedure|Cataract surgery|
16013918|NCT02783196|Drug|Liraglutide|In the LIR arm, the participants will be provided with instructions in using pre-filled single-use plastic syringes ready for once daily subcutaneous injection of LIR. From day 1 to day 10, with LIR daily dose of 0.6 mg (0.1 ml), followed by other 10 day courses (from day 11 to day 20) with LIR 1.2 mg (0.2 ml), then will be up-titrated to high dose 1.8 mg (0.3 ml) of LIR (from day 21 to day 40). At crossover-day 40, the participants will undergo a 14 days wash-out period, day 41 to day 55.
16013919|NCT02783196|Drug|Placebo|In the PLA arm, the participants will be provided with instructions in using pre-filled single-use plastic syringes ready for once daily subcutaneous injection of PLA. Will start with PLA with matched volume saline injections of 0.1 ml PLA during the first 10 days, followed by 10 days, with 0.2 ml PLA, thereafter PLA will be up-titrated to highest volume 0.3 ml placebo for the rest of the PLA treatment period . At crossover-day 40, the participants will undergo a 14 days wash-out period, day 41 to day 55.
16013920|NCT02783183|Drug|YHD1119|2 by 2
16013921|NCT02783183|Drug|Lyrica|2 by 2
16013922|NCT02783170|Biological|Tetanus, Diphtheria, and Pertussis Vaccine|
16013923|NCT02783170|Biological|2016-2017 Quadrivalent Inactivated Influenza Vaccine|
16013924|NCT02783170|Biological|2017-2018 Quadrivalent Inactivated Influenza Vaccine|
16013925|NCT02783157|Device|Transcutaneous Low-Level Vagal Nerve Stimulation (LLVNS)|Low-level vagal nerve stimulation will be delivered via a clip applied to the ear throughout the surgical procedure. The voltage used will be individualized to each patient, based upon the voltage necessary to slow the sinus rate during testing.
16013926|NCT02783157|Device|Sham LLVNS|A clip will be applied to the ear, but no stimulation will be delivered throughout the procedure.
16013927|NCT02783144|Procedure|TAP Block and Dexamethasone|After general anesthesia and before the beginning of surgery, the ultrasound-guided is performed between the internal oblique muscle and the transversus abdominis muscle and dexamethasone is added to levopubivacaine
16013928|NCT02783144|Other|TAP Block and saline|After general anesthesia and before the beginning of surgery, the ultrasound-guided is performed between the internal oblique muscle and the transversus abdominis muscle and saline is added to levopubivacaine
16013929|NCT02783144|Drug|TAP Block and Dexamethasone i.v.|After general anesthesia and before the beginning of surgery, the ultrasound-guided is performed between the internal oblique muscle and the transversus abdominis muscle and dexamethasone is injected intravenously
16013930|NCT02783131|Device|MedNav|MedNav is a tablet based platform device that acts to help teams manage emergencies. In the way that satellite navigation devices have replaced maps on journeys mednav has replaced paper based checklist and guidelines to give teams real-time guidance as the emergency happens. In supports teams by deligating, prompting and scribing as the emergency unfolds. The intervention arm will be taught how to use this device over 30 minutes and then use it in a simulated scenario managing a post partum haemorrhage.
16013931|NCT02783118|Other|Self administered online CBT|"The app being tested has two main components: courses and exercises. Courses represent the psycho-educational and therapeutic background of the program, comprising the following topics: information on depression, psychological vulnerability, what is CBT, healthy and unhealthy negative emotions, rational and irrational thoughts, how behaviors contribute to depression, sleep hygiene, social support, and relaxation techniques. Exercises use the information presented in the courses and follow the structure of a regular therapy session and/or therapeutic homework.
~The following exercises are included in the app:
~The Emotional Pulse exercise
~The Sticky Notes exercise
~The Find Irrational Thoughts
~The Change Irrational Thoughts"
16013932|NCT02783105|Other|Musical intervention|
16013933|NCT02783105|Other|Control|Patients wear headphones twice a day during 30 minutes, starting at the onset of desedation (Day 0) until day 21, but no music is provided (blank playlist): Sham
16013934|NCT02783092|Drug|Cannabidiol|Oral solution of cannabidiol 200 mg / mL dissolved in corn oil. Titration period: 5 mg / kg / day up to 25 mg / kg / day. Maintenance period: highest dose obtained during the titration period (maximum of 25 mg/kg / day)
16013935|NCT02783092|Drug|Placebo|The placebo will be an oral solution of corn oil. Titration period: 5 mg / kg / day up to 25 mg / kg / day. Maintenance period: highest dose obtained during the titration period (maximum of 25 mg/kg / day)
16013936|NCT02783079|Behavioral|CBT|
16013937|NCT02783079|Behavioral|MBSR|
16013938|NCT02783066|Device|Offloading boot: PulseFlow|A new offloading boot, which may enhance balance, gait, and lower extremity blood flow
16013939|NCT02783053|Drug|Metformin|Metformin vs no metformin
16013940|NCT02783040|Drug|Midazolam|
16013941|NCT02783040|Drug|Warfarin|
16013942|NCT02783040|Drug|Omeprazole|
16013943|NCT02783040|Drug|Midazolam|
16013944|NCT02783040|Drug|Digoxin|
16013945|NCT02783040|Drug|BI 425809|
16013946|NCT02783027|Behavioral|SleepTrackTXT2|Participants that report high levels of fatigue, sleepiness, or difficulty with concentration during shift work (intra-shift) will receive tailored text-messages promoting adoption of behaviors that can improve alertness during shift work. Participants will also receive a summary of their sleep debt once a week and suggestions for paying back sleep debt. Participants will also have access to a graphic summary of their sleep hours over previous 30-days.
16013947|NCT02782988|Other|olfactory tests, otoacoustic emissions (OAE)|Two series of olfactory tests will be performed : 1) the first one with simple odorants and 2) the second one with binary mixtures of odorants. These tests of nasal chemosensory performance are based on pen-like odor dispensing devices (Sniffin' Sticks, Burghardt, Wedel, Germany) and measure odor discrimination ability of young children in less than 15 min.
16013948|NCT02782975|Drug|aducanumab|
16013949|NCT02782949|Drug|Curcumin|Given PO
16013950|NCT02782949|Other|Laboratory Biomarker Analysis|Correlative studies
16013951|NCT02782949|Other|Placebo Administration|Given PO
16013952|NCT02782949|Other|Quality-of-Life Assessment|Ancillary studies
16013953|NCT02782936|Other|measurement of the work of breathing|"We have been evaluating breathing patterns, index of respiratory efforts and blood gases in all randomized conditions. A gas mask has been used mask (C4, Airboss Defence, Bromont, Canada).
~Airway pressure, inspiratory and expiratory flows have been measured. An esophageal catheter has been introduced at the beginning of the study to measure esophageal pressure (Peso) and calculate indexes of respiratory effort (PTPeso, WOB). SpO2 has been continuously measured and capillary blood bases were drawn at the end of each condition. Each condition lasted 10 minutes, data of the last 2 minutes at a steady state has been considered for analyses."
16013989|NCT02782650|Other|survey and interview|"all participants: survey on prenatal counseling and treatment decisions at the limits of viability.
~a selection of participants: focus group interviews to further perform in-depth exploration of prenatal counseling preferences"
16014062|NCT02782091|Behavioral|Multiple Errands Test (MET)|1 hour assessment in an unknown district with 2 independent raters.
16077233|NCT02330120|Drug|dexmedetomidine|
16013954|NCT02782936|Device|Gas mask|During the conditions that involved a gas mask, the measurement of the work of breathing is achieved with a oesophageal catheter and two disposable pneumotachs. While the oesophageal catheter has been fixed to the mandibular with an hypo-allergic tape, the two pneumotachs are hooked respectively on the canister and exhalation port of the gas mask. Investigators have induced the hypoxemia with a mixture nitreous and medical gas in a plastic bag that has been setted up to the canister. The FiO2 level has been kept to 14 percent.
16013955|NCT02782923|Device|STISIM driving simulator|This simulator is complete with computerized driving scenarios and driving hardware, has been validated in numerous studies and allows for a more comprehensive investigation of driving performance. The simulated course recreates standard turns, traffic intersections, pedestrian crosswalks, lane changes and several hazardous conditions routinely encountered during driving situations.
16013956|NCT02782910|Device|Smartphone-Based Ambulatory Assessment, Feedback via physician|Participants in the experimental condition SBAA+ will be contacted by their treating physician, once the predefined threshold for Smartphone activity is exceeded.
16013957|NCT02782897|Drug|Immunoglobulin Therapy|Immunoglobulin is given intravenously 0.4 g/kg per day for five consecutive days.
16013958|NCT02782897|Other|Standard management|Standard management includes: the use of mild sedation, blood pressure control, management of elevated intracranial pressure, glucose management, temperature management, airway maintenance, and management of medical complications.
16013959|NCT02782871|Device|Pneupac VR1|A portable mechanical ventilator/resuscitator for medical personnel in the hospital, ambu-lance, fire, and police services.
16013960|NCT02782858|Drug|GNbAC1|Monthly IV repeated dose
16013961|NCT02782858|Drug|Placebo|Monthly IV repeated dose
16013962|NCT02782845|Drug|Chemotherapy|The choice of CT will be as per standard of care and protocol does not specify any particular CT drug.
16013963|NCT02782845|Drug|Immunochemotherapy|The choice of ICT will be as per standard of care and protocol does not specify any particular ICT drug.
16013964|NCT02782845|Drug|Pegfilgrastim|Pegfilgrastim will be administered at a fixed dose of 6 mg subcutaneously 24 hours after the last dose of CT or ICT is received for 6 cycles.
16013965|NCT02782819|Drug|Isotonic crystalloid solution resuscitation|Patient will receive normal saline or Ringer lactate or other balance salt solution during fluid resuscitation for shock reversal.
16013966|NCT02782819|Drug|Colloid solution resuscitation|Patient will receive 5% albumin or gelatin solution during shock resuscitation
16013967|NCT02782806|Device|Masimo Rad-67 Pulse Oximeter|Noninvasive pulse oximeter
16013968|NCT02782793|Procedure|Endoscopic Mucosal Resection|
16013969|NCT02782780|Behavioral|Cognitive Behavioral Therapy for Insomnia (CBTi)|CBTi is a multicomponent treatment that seeks to teach patients about sleep and the factors that affect sleep (e.g., homeostatic regulation, circadian rhythm, age, social and work schedule) and to work with the patients toward minimizing unwanted arousal at bedtime and altering sleep habits to increase sleep propensity and regularity. The intervention is 8-weeks long.
16013970|NCT02782767|Other|Wound catheter infusion|Wound catheter has multiple holes spread around 360 degrees throughout its active length. It is placed in the musculofascial plane during closure of the wound. Local anaesthetic infusion will be delivered through the catheter.
16013971|NCT02782767|Other|Epidural infusion|Epidural catheter will be placed in the level T7-T9 , and local anaesthetic infusion will be given
16013972|NCT02782754|Drug|Carboplatin|
16013973|NCT02782754|Drug|Etoposide|
16013974|NCT02782754|Drug|Cyclophosphamide|
16013975|NCT02782754|Drug|Bleomycin|
16013976|NCT02782754|Radiation|Reduced dose of radiotherapy|
16013977|NCT02782741|Drug|Avalglucosidase alfa (GZ402666)|Pharmaceutical form: powder for concentrate for solution for infusion Route of administration: intravenous
16013978|NCT02782741|Drug|Alglucosidase alfa (GZ419829)|Pharmaceutical form: powder for concentrate for solution for infusion Route of administration: intravenous
16013979|NCT02782728|Behavioral|TIPS-Plus|Patients receive brief psycho-educational messages on a tablet computer following completion of questionnaire about personal experiences of intimate partner violence (IPV), sexual assault (SA), and reproductive coercion (RC). These messages are tailored to each patient and are based on their responses to specific items. The messages serve as prompts to encourage the patient to continue the discussion about various topics (healthy relationships, birth control methods, harm reduction) with their provider during their clinic visit. Simultaneously, providers receive a print out with a series of scripts tailored to the patient's responses to introduce healthy relationships education, brief counseling, and harm reduction.
16013980|NCT02782728|Behavioral|TIPS-Basic|Patients complete tablet questionnaire about personal experiences of IPV/SA/RC and based on responses, providers receive a print out with a series of scripts tailored to the patient's responses to introduce healthy relationships education, brief counseling, and harm reduction.
16013981|NCT02782715|Radiation|Stereotactic Body Radiation Therapy (SBRT)|Patients will be treated on study with a course of SBRT treatment by a radiation oncologist. Three SBRT dose levels targeting the primary tumor will be evaluated; level I: 6 Gy x 5 fractions (a common palliative dose), level II: 8 Gy x 5 fractions, and level III: 10 Gy x 5 fractions (a common definitive dose).
16013982|NCT02782715|Procedure|Microwave Ablation (MWA)|Performed under sedation using ultrasound and computed tomography (CT) guidance for percutaneous antenna placement and confirmation. Depending on size and location of tumor, one to three antennas (Certus 140; NeuWave Medical) will be used. The system is an FDA-approved, high-powered third-generation MW device that uses CO2 gas cooling to prevent shaft heating. The gas cooling allows the probes to be stuck into tissue by creating a small ice ball at the tip using the Joule-Thomson method, similar to the tissue cooling mechanism of cryoablation systems. Probes are 17-gauge, and various ablation zone configurations are available depending on the probe selected. An ablation protocol using the 65W power setting for 5 minutes will be used for most patients. Ultrasound will be used for real-time monitoring of the extent of ablation to achieve a 5mm margin beyond tumor, and immediate post-procedure imaging performed using contrast-enhanced CT (CECT) for patients with adequate renal functions.
16013983|NCT02782702|Drug|Botulism Toxin Treatment|Injection of 50 UI of botulism toxin for treated zone
16013984|NCT02782689|Device|Kit Biflex|Two-layer reusable compression system
16013985|NCT02782689|Device|Profore|Four-layer compression system
16013986|NCT02782676|Device|Investigational Healon5 OVD|ophthalmic viscosurgical device
16013990|NCT02782637|Other|survey and interview|"all participants: survey on prenatal counseling and treatment decisions at the limits of viability.
~a selection of participants: individual interviews to further perform in-depth exploration of prenatal counseling preferences"
16013991|NCT02782624|Drug|Empagliflozin|5 days of treatment with 5 mg BI 10773 bid until steady state
16013992|NCT02782624|Drug|Empagliflozin|5 days of treatment with 10 mg BI 10773 qd until steady state
16013993|NCT02782611|Behavioral|ENHANCE: Enduring Happiness and Continued Self-Enhancement|ENHANCE is a skill-based intervention to teach people a wide variety of strategies that have been shown to boost happiness. Each session of ENHANCE follows a similar format targeted to address three central goals. First, in each session, participants will complete an active learning module designed to educate participants about one of the ten overarching topics featured in this program (e.g., goals, close relationships). Next, participants will engage in activities that put these principles into practice. Finally, this program is designed to encourage a skill-building mindset by helping participants develop habits to integrate these principles into maintained activity in their daily lives moving forward.
16013994|NCT02782598|Device|CRT+NAVH|Cardiac Resynchronization Therapy with Negative Atrioventricular Hysteresis
16013995|NCT02782585|Other|Cervical manipulation|The therapist cradled the subject´s head with the other hand. Gentle ipsilateral side flexion and contralateral rotation to the targeted side were introduced until slight tension was perceived in the tissues at the contact point. The High velocity, low amplitude (HVLA) manipulation was directed upward and medially in the direction of the subject´s contralateral eye. The therapist monitored for cavitation or 'popping sound' accompanying the manipulations. If an audible popping sound was not heard during the first manipulative attempt, the procedure was repeated in the second time.
16013996|NCT02782585|Other|Cervical lateral glide|The upper limb of the right side of subjects was maintained in rest, with the arm along the trunk and the hand over the abdominal wall. The right hand of the treating therapist was positioned over scapula region, to depress the scapula while left hand cradled the occiput and neck above C5-C6 and left hand produced a passive lateral movement of the occipital and neck region.
16013997|NCT02782585|Other|Cervical mobilisation|The patients received a passive cervical mobilization that involved a grade III oscillatory unilateral posteroanterior mobilization to the right articular pillar of C5/C6 segment as described Maitland at a frequency of 2Hz. All the subjects were positioned in prone position as the protocol described by Sterling et al. for 3 sets of 2 minutes with 1 minute rest between sets.
16013998|NCT02782572|Other|Exercise|Exercise in acute heart failure in three different groups (conventional medical treatment; exercise with non-invasive ventilation and exercise with placebo of non-invasive ventilation).
16013999|NCT02782559|Drug|Sildenafil|
16014000|NCT02782559|Drug|Placebo|Color and size matched to active drug (sildenafil)
16014001|NCT02782546|Procedure|Graft cell infusion|-Day 0
16014002|NCT02782546|Drug|Tacrolimus|-GVHD prophylaxis
16014003|NCT02782546|Drug|Mycophenolate mofetil|-GVHD prophylaxis
16014004|NCT02782546|Drug|G-CSF|-Continue until neutrophil engraftment as per institutional guidelines
16014005|NCT02782546|Procedure|CIML NK cell infusion|-Day +7
16014006|NCT02782546|Drug|ALT-803|-Start approximately 4 hours after CIML NK cell infusion
16014007|NCT02782546|Procedure|Leukapheresis|-Day +6
16014008|NCT02782533|Device|Deep Brain Stimulation V3|
16014009|NCT02782520|Drug|Ringer Lactate (10ml/kg) fluid expansion|
16014010|NCT02782520|Drug|Hypertonic saline (3ml/kg) fluid expansion|
16014011|NCT02782507|Behavioral|CBT for Distressing visual hallucinations|"Eight to ten sessions of manualised CBT for distressing visual hallucinations based on existing treatment manuals (ie. Kingdon & Turkington, 2004, Morrison et al., 2005), delivered over 8 to 12 weeks by CBT therapists.
~Subjects will continue to receive treatment as usual throughout the therapy period and will receive appropriate prescription of medication if requested or clinically indicated."
16014012|NCT02782494|Other|Examination of latent TB by QuantiFERON-TB|Examination of latent TB by QuantiFERON-TB both QFT-plus QFT-GIT
16014013|NCT02782481|Drug|ND0612|
16014014|NCT02782481|Drug|Placebo|
16014015|NCT02782468|Drug|Pevonedistat 25 mg/m^2|Pevonedistat 25 mg/m^2 intravenous infusion.
16014016|NCT02782468|Drug|Pevonedistat 44 mg/m^2|Pevonedistat 44 mg/m^2 intravenous infusion.
16014017|NCT02782468|Drug|Pevonedistat 10 mg/m^2|Pevonedistat 10 mg/m^2 intravenous infusion.
16014018|NCT02782468|Drug|Pevonedistat 20 mg/m^2|Pevonedistat 20 mg/m^2 intravenous infusion.
16014019|NCT02782468|Drug|Azacitidine 75 mg/m^2|Azacitidine 75 mg/m^2 intravenous or subcutaneous formulation.
16014020|NCT02782455|Drug|Flavonoids|Daflon is administered
16014021|NCT02782455|Drug|CDobi|Calcium dobesylate is administered
16014022|NCT02782442|Behavioral|Structured Cognitive Training & PRIME|The treatment condition-- 30-35 hours of CT over 16 weeks (~2 hours per week) is a structured program of 20 hours of auditory processing exercises followed by 10 hours of social cognition exercises, combined with the personalized PRIME coaching application
16014023|NCT02782442|Behavioral|Computer Games Control & PRIME|Computer games control condition which comes in the official PositScience wrapper. 30-35 hours of games over 16 weeks (~2 hours per week), combined with the personalized PRIME coaching application.
16014024|NCT02782429|Drug|Ketamine|
16014025|NCT02782429|Other|Saline|
16014026|NCT02782416|Other|Examination of latent tuberculosis|
16014027|NCT02782403|Drug|Axitinib|Given PO
16014028|NCT02782403|Drug|Bosutinib|Given PO
16014029|NCT02782403|Other|Laboratory Biomarker Analysis|Correlative studies
16014030|NCT02782390|Other|Dental Restoration with Stainless Crown|Lesions allocated to this group will be treated with stainless dental crowns according to the Hall Technique protocol (Evans & Innes, 2010).
16014031|NCT02782390|Other|Dental Restoration with Composite Resin|"Surfaces allocated to this group will be treated with composite resin (Z250, 3M ESPE, USA) according to the manufacturer's instructions.
~Initially, local anesthesia and rubber dam adaptation will be performed. Then, 37% phosphoric acid will be applied on the surface for 30 seconds, followed by spray of water/air for at least 15 seconds. Then, the adhesive system (Single Bond, 3M ESPE, USA) will be applied and light cured according to the manufacturer's instructions. Finally, composite resin (Z250, 3M ESPE, USA) will be applied and light cured according to the manufacturer's instructions."
16014034|NCT02782325|Biological|Active FMT, then open label FMT|Endoscopic application of OpenBiome FMT Lower Delivery followed by 2 weeks of treatment with OpenBiome FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
16014035|NCT02782325|Biological|Placebo FMT, then open label FMT|Endoscopic application of Placebo FMT Lower Delivery followed by 2 weeks of treatment with Placebo FMT Capsules G3 with follow-up at week 4, 8, 16 and 24 after inclusion. In case the study patient does not achieve clinical remission at week 4 or experiences a flare of disease on day 15-28 after start of the study he/she will be offered the possibility to participate in open label extension after at least 10 day of antibiotic therapy with an additional endoscopic FMT followed by 2 weeks of oral FMT. Follow-up will occur in open label at week 4, 8, 16 and 24 after open label FMT.
16014036|NCT02782312|Drug|ICS+LABA|Seretide is inhaled for one year
16014037|NCT02782312|Other|routine therapy|routine therapy for one year
16014038|NCT02782299|Other|Decision Aid|Decision aid which is still under revision will include unbiased information to assist is clarifying values and informing patients with distal radius fractures.
16014039|NCT02782286|Drug|Ketorolac|The patients randomised to this arm will receive 30 mg intravenous ketorolac.
16014040|NCT02782286|Drug|Morphine|The patients randomised to this arm will receive 0,1 mg/kg intravenous morphine.
16014041|NCT02782273|Drug|Ketorolac|The patients randomised to this arm they will receive 30 mg intravenous ketorolac.
16014042|NCT02782273|Drug|Morphine|The patients randomised to this arm they will receive 0,1 mg/kg intravenous morphine.
16014043|NCT02782260|Drug|Dipyridamole|
16014044|NCT02782260|Drug|Placebo|
16014045|NCT02782247|Device|Transient elastography|"Transient elastography will be measured using a Fibroscan® machine which is manufactured by echosens®. It has a CE mark of 0459.
~It is a non-invasive method to accurately measure stiffness of a patient's liver without the need for a liver biopsy. This is measured by an externally placed ultrasound probe which creates an elastic shear wave at 50Hz, and measures the velocity of the echo through the liver tissue. The liver stiffness is measured in kilopascals (kPa). It has been shown to be 99% effective in detecting cirrhosis in hepatitis C and has been shown to correlate with hepatoma production in both hepatitis C and hepatitis B. Values range from - normal < 9.6 kPa, significant fibrosis 9.6-11.4kPa, cirrhosis >11.5kPa. It cannot be used in patients with ascites."
16014046|NCT02782247|Device|Indocyanine Green excretion|The machine to monitor the elimination of Indocyanine green is manufactured by PULSION medical systems (Munich, Germany) and consists of the PulsioFlex monitor and LiMON module. The LiMON module is a finger probe which measure near-infrared wavelengths between 805nm and 905nm. The absorption maximum for Indocyanine green is 800nm and emission at 830nm. This is then used to produce two calculations. The first is plasma disappearance rate of indocyanine green (PDRICG). This is based on working out the constant and backward extrapolation and expressed as a percentage per minute. The other is the retention ratio after 15 minutes (ICG15).
16014047|NCT02782234|Behavioral|Contract management|
16014048|NCT02782221|Drug|Growth Hormone|Subjects are receiving one injection of growth hormone (Genotropin) 0,5 mg
16014049|NCT02782221|Drug|Pegisomant|One the placebo day the subjects are receiving injection with pegvisomant (Somavert 30 mg) to block the action of endogenous growth hormone
16014050|NCT02782208|Drug|Acipimox|Acipimox is administered 4 times previous to and during the investigation day. Acipimox is used to suppress the lipolytic effect of GH.
16014051|NCT02782208|Drug|Placebo|Placebo is administered 4 times previous to and during the investigation day.
16014052|NCT02782208|Drug|GH substitution|GH substitution as usually
16014053|NCT02782208|Other|GH pause|GH substitution pause two days prior to the experimental day
16014054|NCT02782182|Drug|FOLFIRINOX (oxaliplatin, leucovorin, irinotecan)|FOLFIRINOX administered preoperatively and postoperatively
16014055|NCT02782169|Drug|Pregabalin|Pregabalin 300 mg capsule (over encapsulated to maintain blinding)
16014056|NCT02782169|Drug|Placebo|Matching placebo capsule with excipient to match Pregabalin
16014057|NCT02782156|Other|Process evaluation|Adherence to screening and action algorithm
16014058|NCT02782130|Behavioral|Epic Allies App Intervention|"The Epic Allies app addresses barriers to ART adherence through:
~Users track health progress through an interactive dashboard, logging daily adherence for those on ART and, optionally, exercise, smoking, alcohol and drug use, and mood. Those not on ART will rate how close they are to getting on it.
~Users pick medication reminder timing. The app sends weekly messages to users based on adherence progress and other tracked behaviors.
~A key part of the app is contact between users to foster a setting that supports norms for medication-taking, reducing stigma related to HIV status and ART use. Users send and receive encouragement to spur behavior change, recognize positive behaviors, and inspire others to reach an adherence goal.
~Users progress through Epic Allies' virtual world, creating allies with other users.
~The Daily Dose newspaper has content to improve HIV/ART knowledge, promote disease management and increase drive and self-efficacy."
16014059|NCT02782130|Behavioral|Epic Allies - Control Branch|Subjects will receive weekly phone-based notifications to encourage the subjects to view educational information presented in the app.
16014060|NCT02782117|Device|Luminopia One|Luminopia One is a digital therapeutic that allows patients to watch videos with therapeutic modifications applied.
16014138|NCT02781454|Drug|Mexiletine|
16014139|NCT02781454|Drug|Placebo|
16014063|NCT02782078|Biological|Clindamycin and rifampicin dosages|blood samples for clindamycin and rifampicin dosages (for each patient)
16014064|NCT02782065|Other|Not an interventional study|
16014065|NCT02782052|Drug|Nebulized ipratropium bromide|"Administration at V3 or V4 or V5 in a random order:
~Placebo (P; sterile 0.9% sodium chloride solution)
~Or nebulized ipratropium bromide (IB; 0.5mg/2mL) alone
~Or nebulized combination ipratropium bromide with salbutamol (IB+SALB; 0.5mg/2mL + 2.5mg/2.5mL)."
16014066|NCT02782052|Drug|Nebulized combination ipratropium bromide with salbutamol|"Administration at V3 or V4 or V5 in a random order:
~Placebo (P; sterile 0.9% sodium chloride solution)
~Or nebulized ipratropium bromide (IB; 0.5mg/2mL) alone
~Or nebulized combination ipratropium bromide with salbutamol (IB+SALB; 0.5mg/2mL + 2.5mg/2.5mL)."
16014067|NCT02782052|Drug|Nebulized Placebo|"Administration at V3 or V4 or V5 in a random order:
~Placebo (P; sterile 0.9% sodium chloride solution)
~Or nebulized ipratropium bromide (IB; 0.5mg/2mL) alone
~Or nebulized combination ipratropium bromide with salbutamol (IB+SALB; 0.5mg/2mL + 2.5mg/2.5mL)."
16014068|NCT02782026|Device|Exhaled Breath Olfactory Signature (Artificial Nose)|
16014069|NCT02782000|Other|lessons,long-term supervision and message|
16014070|NCT02782000|Other|lessons,short-term supervision and message|
16014071|NCT02781987|Other|chronic pancreatitis|patients with chronic pancreatitis
16014072|NCT02781974|Other|Exercise|Strength and balance exercise in Groups, focusing on lower limb strength, back strength and static and dynamic balance
16014073|NCT02781961|Other|cellvizio|pCLE during gastroscopy
16014074|NCT02781948|Device|Optical Coherence Tomography|
16014075|NCT02781935|Procedure|DW-MRI|DW-MRI combined with Contrast Enhanced MRI will be used to confirm the status of disappearing liver metastasis prior to surgery and will be compared to findings from either histopathology of resected lesions (Rubbia-Brandt Classification of Tumor regression grading) or follow-up imaging of lesions left behind (either CT scan or MRI) after surgery. MRI will be used during the follow-up period to confirm recurrences from a previous site of DLM.
16014076|NCT02781922|Genetic|Autologous cardiac stem cells (JRM-001)|3x 10^5 cells/kg, single treatment
16014077|NCT02781909|Drug|Ibuprofen|Non-Steroid Anti-Inflammatory drug to be administered as adjunctive therapy
16014078|NCT02781909|Drug|Standard of Care TB treatment|Standard of Care (SoC) TB Treatment will be optimized and drugs selected according to the National and WHO Guidelines, sensitivity profile and as per routine.
16014079|NCT02781896|Device|pacing catheter|Rapid pacing during TAVI is required to ensure transient cardiac standstill while predilatation is performed and the valve is being positioned and deployed. In the right ventricular pacing arm, rapid pacing is provided by a standard right ventricular pacing catheter.
16014080|NCT02781896|Device|valve delivery guidewire|Rapid pacing during TAVI is required to ensure transient cardiac standstill while predilatation is performed and the valve is being positioned and deployed. In the Left ventricular pacing arm, rapid pacing is provided via the valve-delivery guidewire inserted into the left ventricle. The cathode of an external pacemaker is placed on the external end of the guidewire using an alligator clamp. The TAVI catheter provides the necessary insulation. The anode is attached directly to the subcutaneous tissue at the femoral entry site (also using an alligator clamp).
16014081|NCT02781883|Drug|BP1001 in combination with Ventoclax plus decitabine|BP1001 in combination with Ventoclax plus decitabine
16014082|NCT02781883|Drug|BP1001 plus decitabine|BP1001 plus decitabine in ventoclax intolerant or resistant subjects
16014083|NCT02781870|Procedure|LiquiBand Fix8 glue fixation|Patients will be operated in a standard procedure to receive the 3D ENDOLAP visible with LiquiBand® Fix 8™ glue fixation.
16014084|NCT02781870|Procedure|No-fixation|Patients will be operated in a standard procedure to receive the 3D ENDOLAP visible without glue fixation.
16014085|NCT02781857|Other|No intervention|
16014086|NCT02781844|Drug|25mcg rhPTH(1-84)|Participants will receive rhPTH(1-84) as twice-daily regimen (12 hours apart) of two 25mcg doses without calcium in cohort 1 and with calcium in cohort 3.
16014087|NCT02781844|Drug|50mcg rhPTH(1-84)|Participants will receive rhPTH(1-84) as twice daily regimen (12 hours apart) of two 50mcg doses without calcium in cohort 2 and with calcium in cohort 4
16014088|NCT02781844|Drug|100mcg rhPTH(1-84)|Participants will receive rhPTH(1-84) as once-daily regimen of one 100 mcg dose without calcium in cohort 1 and 2 and with calcium in cohort 3 and 4 in the morning.
16014089|NCT02781831|Procedure|Standard rehab|Standard hospital based rehabilitation for patients with stroke
16014090|NCT02781831|Device|Robot-assisted gait rehabilitation|An extra 30 minutes of robot-assisted gait rehabilitation after receiving standard hospital based rehabilitation for patients with stroke
16014091|NCT02781818|Drug|Triamcinolone Acetonide 10mg/mL|Triamcinolone acetonide is a glucocorticoid used in intralesional treatment of many skin diseases, intra-articular treatment of inflammatory joint diseases, and intramuscular treatment for systemic management of systemic inflammatory diseases. It is commonly used in clinical practice for the treatment of acute abscesses and nodules of hidradenitis suppurativa, but little clinical trial data exist supporting its use.
16014092|NCT02781818|Drug|Triamcinolone Acetonide 40mg/mL|Triamcinolone acetonide is a glucocorticoid used in intralesional treatment of many skin diseases, intra-articular treatment of inflammatory joint diseases, and intramuscular treatment for systemic management of systemic inflammatory diseases. It is commonly used in clinical practice for the treatment of acute abscesses and nodules of hidradenitis suppurativa, but little clinical trial data exist supporting its use.
16014093|NCT02781818|Drug|Normal Saline|Normal saline 0.1 mL will be administered intralesionally at the selected site.
16014094|NCT02781805|Drug|Alendronate|10 mg (1 tablet) once daily for 1-3 weeks before breast surgery; drug will be discontinued the day before surgery.
16014095|NCT02781792|Drug|Temozolomide|-Given standard of care
16014140|NCT02781441|Behavioral|Question prompt list (QPL)|
16014141|NCT02781441|Behavioral|Education brochure of Groupe Français des Myélodysplasies|
16014173|NCT02781142|Other|Motor imagery training|The motor imagery training will be designed for the individual basis with following standard protocols. It will be applied two times a week for 8 weeks. The first one and/or two sessions will be performed in the clinic, the other will be performed at the patients' home with a video-conference telerehabilitation technique.
16014264|NCT02780544|Behavioral|skin-to-skin contact|skin-to-skin contact with parent during eye examination.
16080024|NCT02308202|Drug|Perindopril|
16014096|NCT02781792|Other|Functional Assessment of Cancer Therapy - Brain|"23-item questionnaire that can be completed in 5 to 10 minutes with little or no assistance in patients who are not neurologically incapacitated. This brain subscale is usually used along with the core (general) questionnaire [2] that includes 27 items.
~Patients rate all 5 items using a five-point Likert scale ranging from 0 not at all to 4 very much. Overall, higher ratings suggest higher QOL. Items are totaled to produce the following subscales, along with an overall QOL score: physical well-being (7 items); social/family well-being (7 items); emotional well-being (6 items); functional well-being (7 items); and concerns relevant to patients with brain tumors (23 items)
~The sleep portion of this questionnaire consists of 17 questions about sleeping patterns and the ability to rate severity of insomnia."
16014097|NCT02781792|Other|ActTrust Condor Instrument Watch|-Will be required to wear 24 hours per day and will only be removed at specified data collection time points
16014098|NCT02781779|Device|Silverlon®|Silverlon wound dressings
16014099|NCT02781779|Device|AQUACEL® AG|AQUACEL® AG wound dressings
16014100|NCT02781766|Other|Thrombin generation measurement.|
16014101|NCT02781753|Biological|Human Serum Albumin/interferon alpha2b|Human Serum Albumin/interferon alpha2b fusion protein 300-1200 μg single dose S.C. at Day0
16014102|NCT02781753|Biological|Peginterferon 180 μg single dose S.C.|Pegasys 180 mcg S.C. single dose on Day 0
16014103|NCT02781740|Device|Continous Positive Air Pressure Device|
16014104|NCT02781727|Drug|Once weekly subcutaneous injection of TransCon hGH|Once weekly subcutaneous injection
16014105|NCT02781727|Drug|Once daily subcutaneous injection of Genotropin|Once daily subcutaneous injection
16014106|NCT02781714|Behavioral|Two-way SMS|"SMS messages will provide tailored and actionable education, counseling, and reminders specific to antenatal/postpartum timing and partner track. Messages will include questions and prompts; women and their male partners have the option of writing back to a nurse with questions or concerns, who will provide real-time responses via text and/or make referrals to a clinic. Message content will be tailored to women and couples, and will range from health benefits of child spacing and an emphasis on contraceptive options, to the hierarchy of effectiveness and information on specific methods, to simple reminders about postpartum visits.
~Prior to randomization, each enrolled woman will be asked if she has a male partner, and whether she would like to refer her male partner for recruitment and enrollment into the study. The partner tracks are as follows:
~Male partner invited to enroll/enrolled
~Male partner not invited to enroll
~Unpartnered"
16014107|NCT02781701|Device|Tongue Trainer|"The strength of participants tongue will be measured and participants will be shown how to perform tongue training exercises using a special device. Participants will be given instructions on how to perform a workout for the tongue. Each day once in the morning (am) and once in the afternoon/evening (pm), participants will train with the device and have a tongue workout that lasts about 10 minutes.
~Therefore, participants will work out about 20 minutes a day for 6 weeks."
16014108|NCT02781688|Behavioral|Physical Activity|"Self-monitoring: Subjects will be provided with a commercially available activity monitor (i.e., Fitbit) and instructed to wear the device daily.
~Active Living counseling: The Active Living counseling program will consists of 12 weekly group educational sessions, facilitated by project interventionists. These sessions will involve discussion of topics related to increasing physical activity, including: identifying and overcoming barriers, setting goals, social support, and time management.
~Facility Access: Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.)."
16014109|NCT02781675|Other|Dietary Intervention|3 wk dietary intervention with prescribed menus and ~50% foods provided.
16014110|NCT02781662|Behavioral|Pharmacist Home-Visit|
16014111|NCT02781649|Drug|Zepatier|Fixed dose Grazoprevir 100 mg/Elbasvir 50 mg by mouth daily for 12 weeks
16014112|NCT02781649|Drug|Ribavirin|Ribavirin 1200 mg/d (> 75 kg) or 1000 mg/d (< 75 kg) by mouth daily in two divided doses
16014113|NCT02781649|Drug|Sofosbuvir|Sofosbuvir 400 mg daily
16014114|NCT02781636|Device|Device: StimGuard Protect System|Lead implanted adjacent to tibial nerve. Wireless rechargeable system.
16014115|NCT02781623|Procedure|MRI|
16014116|NCT02781610|Drug|Standard of care IV antibiotic(s)|IV antibiotics will be selected by the treating physician following standard of care. Duration of treatment is the assigned intervention.
16014117|NCT02781597|Drug|Tranexamic Acid|Patients will receive Inj Tranexamic acid, in IV in a loading dose of 1 g over 10 min followed by an infusion of 1 g over 8 h in 500ml normal saline
16014118|NCT02781597|Drug|Placebo|Patients will receive 0.9% normal saline
16014119|NCT02781584|Drug|SEL|Administered orally once daily
16014120|NCT02781584|Drug|Firsocostat|Administered orally once daily
16014121|NCT02781584|Drug|Cilofexor|Administered orally once daily
16014122|NCT02781584|Drug|Fenofibrate|Administered orally once daily
16014123|NCT02781584|Drug|Vascepa|Administered orally two times daily
16014124|NCT02781571|Drug|SOF/VEL|400/100 mg tablet administered orally once daily
16014125|NCT02781558|Drug|SOF/VEL|400/100 mg FDC tablet administered orally once daily
16014126|NCT02781558|Drug|RBV|RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16014127|NCT02781519|Drug|THC|Active THC (0.015mg/kg) administered over 10 minutes
16014128|NCT02781519|Drug|Placebo|Control: small amount of alcohol (quarter teaspoon), with no THC over 10 minutes
16014129|NCT02781506|Drug|Nivolumab|Nivolumab IV, administered per standard of care according to institutional guidelines at the discretion of the treating medical oncologist
16014130|NCT02781506|Radiation|SAbR|SAbR (1-3 lesions)
16014131|NCT02781493|Drug|2 mg Prucalopride plus 2 L Polyethylene Glycol regimen|Patients enrolled in the Prucalopride group will recieve 2 mg Linaclotide plus 2 L Polyethylene Glycol regimen before colonoscopy.
16014132|NCT02781493|Drug|2 mg Placebo plus 2 L Polyethylene Glycol regimen|Patients enrolled in the Placebo group will recieve 2 mg Placebo plus 2 L Polyethylene Glycol regimen before colonoscopy.
16014133|NCT02781480|Biological|AAV RPE65|Comparison of different dosages of AAV RPE65
16014134|NCT02781467|Biological|PNK-007|
16014135|NCT02781467|Drug|Cyclophosphamide|
16014136|NCT02781467|Drug|Fludarabine|
16014137|NCT02781467|Drug|Human recombinant Interleukin-2 (rhIL-2)|
16014142|NCT02781415|Procedure|Traditional Acupuncture Session|"Skin disinfection was made by an antiseptic solution in the sites of insertion and sterile acupuncture needles were used (0.25 x 0.5 mm).
~Patients were installed in a seated position and needles were inserted perpendicularly through the skin to a depth of 1 - 2 cm until the De Qi was achieved.
~The DeQi corresponds to a feeling of numbness and tingling within the range of acupoint, The insertion sites are represented by the urinary bladder meridian points to the side of the pain (UB21, UB22, UB23, UB24, UB26, UB45, UB46, UB47, UB48 and UB49)."
16014143|NCT02781415|Drug|Morphine Titration|"Morphine was previously prepared by a study nurse by diluting a 10 mg / 1 ml flakon of morphine chlorhydrate in a 9 ml solution of serum saline to obtain a 10 ml preparation (1 ml = 1 mg).
~An initial bolus of 0.1 mg per Kg of actual body weight of morphine chlorhydrate solution is administered.
~A titration dose of 0.1 mg / Kg of body weight was repeated every 5 minutes' interval until reaching the therapeutic goal."
16014144|NCT02781402|Procedure|4 weeks of Aerobic Training|The duration of aerobic training was 40 minutes for each session and 3 days per week with the intensity of 75-80% of their maximum heart rate. The participants were needed to walk or jog on treadmill during the first 10 minutes at the intensity of 50-60% of maximal heart rate (HR max). The aerobic training was followed by 4 x 4 minutes intervals at 75-80% HR max. The participants were given 3 minutes active breaks in between the intervals in which they can either walk or jog at 50-60% of maximal heart rate.
16014145|NCT02781376|Other|CHICA OSA|Computer decision support system module that assesses snoring, assesses additional OSA symptoms, provides guideline-based recommendation to PCPs, and reassesses for residual OSA symptoms.
16014146|NCT02781376|Other|Snoring Identification Only|Computer decision support system module that assesses snoring and alerts the PCP when caregivers endorse snoring.
16014147|NCT02781363|Other|Thoracic ultrasound|
16014148|NCT02781363|Other|CXR|
16014149|NCT02781350|Other|HFHC meal|900 Cal high fat high carbohydrate fast food meal (HFHC). meal includes egg muffin and sausage muffin sandwiches and two hash browns which contain 88g carbohydrates, 51 g fat (33% saturated) and 34 g protein (carbohydrates 41%, protein 17%, and fat 42%).
16014150|NCT02781350|Dietary Supplement|HFHC MEAL plus Fiber|900 Cal high fat high carbohydrate fast food meal containing egg muffin and sausage muffin sandwiches and two hash browns which contain 88g carbohydrates, 51 g fat (33% saturated) and 34 g protein (carbohydrates 41%, protein 17%, and fat 42%).with FiberOne Original cereal 14 grams (half cup) each before and after the HFHC meal
16014151|NCT02781324|Procedure|Posterior Spinal Fusion|
16014152|NCT02781324|Device|Ultrasonic Bone Scalpel|
16014153|NCT02781311|Drug|Setipiprant|Setipiprant tablets, orally, BID for 24 weeks.
16014154|NCT02781311|Drug|Placebo|Placebo tablets, orally, BID for 24 weeks.
16014155|NCT02781311|Drug|Finasteride|Finasteride tablet, orally, once daily for 24 weeks.
16014156|NCT02781298|Dietary Supplement|New Infant Cereal|The infants will start the complementary feeding with the infants cereals of this study, the amount of cereal ingested will be free according to pediatricians recommendations.
16014157|NCT02781298|Dietary Supplement|Multicereals Infant Cereal|The infants will start the complementary feeding with the infants cereals of this study, the amount of cereal ingested will be free according to pediatricians recommendations.
16014158|NCT02781272|Procedure|Pelvic imaging|Within 60 days prior to the pelvic mass evaluation procedure, each subject must have a pelvic imaging study (e.g. ultrasound, CT scan, MRI, etc.) conducted and read to visualize the pelvic mass according to the current standard of care. Results of the pelvic imaging study(ies) will be recorded.
16014159|NCT02781272|Procedure|Blood draw|Within 30 days prior to, or on the day of the pelvic mass evaluation procedure, collect up to 35mL of whole blood into one 5mL SST tube, which must be drawn first, followed by three separate 10mL EDTA tubes.
16014160|NCT02781272|Procedure|Imaging guided biopsy, surgical biopsy or surgical excision|Imaging guided biopsy, surgical biopsy or surgical excision for evaluation of the pelvic mass will be performed by a qualified individual. Tissue samples will be sent to the local pathology department for histological examination in accordance with standard institutional practices. Results of the histopathological evaluation will be recorded, including the final diagnosis along with histological sub-type, and if available, stage and grade of cancer where disease is identified.
16014161|NCT02781259|Procedure|Axillary lymph node dissection|Lymph node dissection is performed in axillary lymph node level I and II. In case of palpable nodes in level II, additional lymph node dissection in level III is done.
16014162|NCT02781259|Drug|Indocyanine green|10cc of 20μg/mL indocyanine green is injected at the nipple-areola complex before surgery
16014163|NCT02781259|Device|Imaging devices|Near-infrared fluorescence is collected by imaging lenses and digital camera.
16014164|NCT02781246|Drug|perineural dexmedetomidine|"Children scheduled for arm and forearm surgery underwent supraclavicle brachial plexus blocks with ropivacaine and dexmedetomidine guided by ultrasound visualisation were randomly assigned five groups: Group A (perineural ropivacaine), Group B (ropivacaine plus 0.5 mcg/kg dexmedetomidine), Group C (ropivacaine plus 1 mcg/kg dexmedetomidine), Group D (ropivacaine plus 1.5mcg/kg dexmedetomidine) and Group E (ropivacaine plus 2 mcg/kg dexmedetomidine). In each group, children received a certain concentration of ropivacaine which adjusted by the Dixon up-and-down method for supraclavicle brachial plexus. The first child received 0.2% ropivacaine , and the concentration of ropivacaine varied by 0.1% according to the up-and-down method. The primary endpoint was the minimum local anesthetic concentration (MLAC)."
16014165|NCT02781233|Other|Progressive resistance training|Progressive resistance training program
16014166|NCT02781233|Other|Normal daily activities|Usual daily activities
16014167|NCT02781194|Device|3M™ Bair Hugger™|forced-air warming blanket
16014168|NCT02781194|Device|F&P HumiGard™ Surgical Humidification System|warmed, humidified insufflation
16014169|NCT02781181|Device|CAS with CPD|using a neuroprotection device
16014170|NCT02781181|Other|CAS without CPD|No Neuroprotection
16014171|NCT02781168|Device|use of earmuffs|The earmuffs are brand Natus® Pediatrics, Neonatal Noise Attenuators called MiniMuffs®, San Carlos, California, USA, which allow the reduction of sound pressure levels 7 to 12 decibels. Are devices that have oval and anatomical shape that allow proper positioning of the ears of newborns. They are made with a soft foam and has hydrogel adhesive on the outer edges for attachment to the skin.
16014172|NCT02781155|Other|Moxibustion|Participants are taught to self administer moxibustion to acupuncture point Zusanli St-36 daily throughout the course of their chemotherapy
16014174|NCT02781129|Other|electrical stimulation|Stimulation applied will be within parameters commonly used for the treatment of epilepsy during periods of encoding, recall, and memory maintenance .
16014175|NCT02781103|Other|Guided imagery plus active tDCS|The subject will be positioned in the sitting/reclining position in a quiet room with the lights dimmed. The tDCS device and audio headphones will be placed on the subject's head. The tDCS device to be used is the Soterix Medical 1X1 device using 2.0 mA of current. The electrodes that will be used will be standard sponge electrodes. The subject will listen to a scripted guided imagery CD specifically developed for women with chronic pelvic pain through the audio headphones. The guided imagery plus active tDCS arm will have tDCS for 20 minutes concurrently with Guided Imagery.
16014176|NCT02781103|Other|Guided imagery plus Sham tDCS|The subject will be positioned in the sitting/reclining position in a quiet room with the lights dimmed. The tDCS device and audio headphones will be placed on the subject's head. The tDCS device to be used is the Soterix Medical 1X1 device using 2.0 mA of current. The electrodes that will be used will be standard sponge electrodes. The subject will listen to a scripted guided imagery CD specifically developed for women with chronic pelvic pain through the audio headphones. The sham arm will have 30 seconds of tDCS, but after 30 seconds the device will be turned off. The device will remain in place until the subject has listened to 20 minutes of the guided imagery CD.
16014177|NCT02781090|Behavioral|PSFW+|PSFW+ is an eight session motivational/educational web-program promoting cessation for HIV-infected smokers. It includes a professionally administered social network/online support community.
16014178|NCT02781090|Behavioral|AHA|The AHA Getting Healthy website is a health-promoting, seven-module website developed by the American Heart Association to encourage healthy behaviors in the general population
16014179|NCT02781090|Drug|Nicotine polacrilex|All participants, in both study arms, will be offered a 3-month supply of nicotine patches
16014180|NCT02781077|Procedure|Structured, Progressive, Task-oriented exercise program|The intervention is walking related task-oriented exercise program with three progressive steps at moderate to high intensity. Each step consists of 60 minutes last ten tasks to optimize walking function of stroke individuals.
16014181|NCT02781064|Drug|Atorvastatin 20mg|Atorvastatin and matching placebo to be taken in a randomised order for 12 months
16014182|NCT02781064|Drug|Placebo|Atorvastatin and matching placebo to be taken in a randomised order for 12 months
16014183|NCT02781051|Behavioral|Print-based education|All subjects will be given a copy of Exercise for Health: An Exercise Guide for Breast Cancer Survivors. Topics covered within the book include benefits of exercise in breast cancer survivors; recommendations on type, duration, frequency and intensity of exercise; goal-setting; and advice on overcoming barriers.
16014184|NCT02781051|Device|Fitbit|Subjects will be provided with a commercially available activity monitor (i.e., Fitbit) and instructed to wear the device daily.
16014185|NCT02781051|Behavioral|Active Living counseling|The Active Living counseling program consists of 12 weekly group educational sessions, facilitated by project interventionists. These sessions will involve discussion of topics related to increasing physical activity, including: identifying and overcoming barriers, setting goals, and time management.
16014186|NCT02781051|Other|Facility Access|Subjects will have access to the exercise lab in the UT Southwestern Depression Center consisting of equipment for aerobic exercise (treadmills, stationary bikes, etc.).
16014187|NCT02781038|Behavioral|Teaching intervention|Subjects will receive a pamphlet which describes the relationship between smoking and negative outcomes in fracture healing.
16014188|NCT02781038|Behavioral|Control|Subjects in this group will not receive the pamphlet
16014189|NCT02781025|Other|Blood draw|A blood sample of 10mL- 25mL will be collected before the start of radiation treatment.
16014190|NCT02780999|Device|Whale orthosis|Participants will be teach how to use the Whale orthotic to be carried for a period of three months during night and during the day in dose activities that cause pain
16014191|NCT02780999|Device|Colditz orthosis|Participants will be teach how to use the Colditz orthotic to be carried for a period of three months during night and during the day in dose activities that cause pain.
16014192|NCT02780986|Behavioral|Female entertainment worker intervention group|"The following summarises the content of each session:
~Session 1 (on-site): The peer educator will play 2 videos, demonstrating 5 sexy ways of putting on a condom in a pleasurable manner, and another one focusing on condom negotiation skills.
~Session 2 (online): The peer educator will share an app game on condom usage and relevant online resources with the participants.
~Session 3 (onsite): There will be discussion of common problems encountered in condom usage and condom negotiation by the participants. The peer educators will then conduct role plays with the participants to demonstrate the counter-strategies. In addition, the peer educators will get the participants who have been successful in condom negotiation to share their success stories.
~Session 4 (online): The peer educator will share information about safe consumption of alcohol and tips to avoid getting drunk through the online platforms."
16014193|NCT02780986|Behavioral|Heterosexual men intervention group|"This will be delivered via 3 main activities:
~Edutainment in the form of talk-shows based on 6 themes of sexual well-being and safe sex, held in the EE setting hosted by a famous female local comedian.
~Web portal named THINK: This contains educational materials based on 6 themes of sexual health and safe sex, HIV risk profiling tool to calculate the risk of contracting HIV, videos on true life experiences of heterosexual men engaging in high risk sexual behaviour and another video on exit strategies to avoid casual or paid sex, online support for STI testing services and consultation with a clinical sexologist.
~Public education event/photo booth: i. Distribution of pamphlets and brochures on sexual well-being and safe sex ii. Interactions with health promoters iii. Photo taking on safe sex messages iv. Free access to condoms and lubricants"
16014194|NCT02780973|Other|Wearing of an intraoral device with bovine tooth samples|Wearing of an intraoral device with bovine tooth samples
16014195|NCT02780960|Device|HPV self-testing|Patients will perform HPV testing themselves at home.
16014196|NCT02780947|Procedure|Ventricular tachycardia substrate ablation|"Study protocol
~Baseline programmed ventricular stimulation performed from the LV
~High density endocardial LV mapping using CARTO® 3 System
~Randomized substrate ablation in half patients. Ablation end-point is considered the elimination of all endocardial late and early potentials (LPs and EPs)
~Final programmed ventricular stimulation performed from the LV
~Programmed ventricular stimulation with up to 4 extrastimuli from LV is performed and repeated at the end of the procedure in patients undergoing substrate ablation."
16080025|NCT02308202|Drug|Placebo|
16014197|NCT02780934|Other|Pressure Dressing|Patients in this group will receive the standard post-operative bandage: a pressure dressing consisting of high absorbency gauze and retention tape.
16014198|NCT02780934|Other|Simple Adhesive Dressing|Patients in this group will receive the experimental bandage: a simple adhesive dressing consisting of a non adherent pad and transparent dressing.
16014199|NCT02780921|Procedure|prehabilitation|
16014200|NCT02780921|Other|nutritional support|
16014201|NCT02780908|Other|Graded exercise testing|All graded exercise tests will be performed on electromagnetically controlled cycle-ergometer Ergo Bike Premium. The testing protocol will commence with a 10-min resting period, to obtain the resting cardio-respiratory values, followed by a 5-min warm up at a work rate of 60 W. Thereafter the workload will increase every fourth minute by 40 W. The participants will be required to maintain a cadence of 60·min-1 throughout the whole test. The test is terminated when the participant is unable to maintain the assigned cadence.
16014202|NCT02780908|Other|Resting testing|The resting test will be performed in supine position with participants breathing normoxic air (FiO2=0.21) for 30 min and hypoxic gas for the subsequent 30-min (FiO2=0.120). During the whole protocol duration the respiration, local blood flow, ECG and EEG will be measured non-invasively.
16014203|NCT02780895|Drug|Human Stem Cells|"MRI-guided stereotactic intraputaminal cell implantation into PD patients was performed.
~For target locations, measurements were made using CT-scan images fused with previous MR images. Bilateral parasagittal incisions and corresponding 14 mm burr holes were made in preparation for cell suspension injections.
~To ensure complete cell suspension delivery, injections were carried out slowly for 2 min with reciprocal withdrawal of the delivery needle to avoid both damage to stem cells and brain tissue, as well as to avert reflux or bubble formation.
~After surgery, patients were kept in a conventional post-operative care unit for 1 h. The day following surgery, MR images were obtained to confirm correct placement of cell suspensions. All patients were discharged 24 h after surgery."
16014204|NCT02780882|Drug|Pasireotide|
16014205|NCT02780869|Device|HEMOBLAST Bellows|
16014206|NCT02780869|Device|Absorbable gelatin sponge, USP with thrombin|
16014207|NCT02780856|Device|Imaging with the Calcivis System|Following identification of both sound and unsound tooth surfaces, the teeth will be air-dried and a black & white and luminescent image of each tooth taken. The images of each tooth will be overlaid and a resulting demineralization map of the tooth produced, indicating areas of elevated bioluminescence corresponding to free calcium ions on the surface of the tooth (active caries)
16014208|NCT02780843|Other|Computerized Tomography|Standard Operational Plan at admission: CT and CT-angiography
16014209|NCT02780843|Other|Magnetic Resonance Imaging|Standard Operational Plan at admission: Diffusion Weighted Imaging (DWI), T2-FLAIR, Gradient and arterial Time-of Flight (TOF)
16014210|NCT02780830|Drug|AZD2014|AZD2014 will be supplied as oral tablets. AZD2014 will be taken orally twice per day on an intermittent dosing schedule, 2 days on and 5 days off of each week.
16014211|NCT02780830|Drug|Ibrutinib|Ibrutinib will be provided in hard gelatin capsules in opaque high-density polyethylene bottles. On days of AZD2014 dosing, ibrutinib will be taken with the morning dose of AZD2014.
16014212|NCT02780817|Other|Error enhancement|Participants will sit in front of a 3D robotic device and grab the robotic arm handle. The participants will carry out arm reaching tasks appear on a screen on front of them. Each game of tasks will lasts 2 minutes. The participants will carry out one game to be accustomed to device, followed by one game with null force field, followed by 5 games as the main intervention with error enhancement force field, and another last game with null force field.
16014213|NCT02780817|Other|Control group|Participants will sit in front of a 3D robotic device and grab the robotic arm handle. The participants will carry out arm reaching tasks appear on a screen on front of them. Each game of tasks will lasts 2 minutes. The participants will carry out one game to be accustomed to device and another 7 games with null force field.
16014214|NCT02780804|Drug|Entinostat|Given PO
16014215|NCT02780804|Other|Laboratory Biomarker Analysis|Correlative studies
16014216|NCT02780804|Other|Pharmacological Study|Correlative studies
16014217|NCT02780791|Other|Transplantation into pelvic wall|Ovarian tissue will be transplanted subperitoneal into the loge of the adnexa of Uterus.
16014218|NCT02780791|Other|Transplantation into the ovary|Ovarian tissue will be transplanted contralateral into the ovary.
16014219|NCT02780778|Drug|Apatinib|Targeted therapy Apatinib：500 mg，po，qd
16014220|NCT02780778|Drug|Docetaxel|chemotherapy Docetaxel：60mg/m²，vein input 1hour，every 3w
16014221|NCT02780765|Device|heated humidifier|30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using Heated Humidifier(HH)
16014222|NCT02780765|Device|mist humidifier|30 patients requiring overnight intubation but breathing spontaneously without ventilatory support will be supplied humidified oxygen using mist humidifier
16014223|NCT02780752|Drug|hymecromone|Oral Hymecromone
16014224|NCT02780739|Behavioral|Cognitive Training - 48 sessions|Mind Frontiers cognitive training software (Aptima Inc.) is a Wild West-themed Android application played on Nexus 10 tablets. This intervention includes 20 70-min sessions (23.33 hrs) completed over 12 weeks: 1/wk weeks 5-8, 2/wk weeks 9-16. The 6 mini-games, played in random order for 10 min each session, are Ante Up (Tower of London, executive functioning); Irrigator (visuospatial reasoning); Pen 'Em Up (dual task switching, executive function); Supply Run (Keep Track, working memory updating); Riding Shotgun (visuospatial working memory); and Sentry Duty (dual n-back, working memory). There is also a meta-game in which players build a town using resources earned from the mini-games, played for 5 min each session.
16014225|NCT02780739|Behavioral|Fitness|Based on high intensity cardiovascular resistance training (HICRT), this intervention includes a combination of aerobic and strength training. Sessions are conducted in a group of ≤20 participants per class, with ≤5 participants per trainer. This intervention includes 28 70-min sessions (32.67 hrs) completed over 16 weeks: 3/wk weeks 1-4, 2/wk weeks 5-8, 1/wk weeks 9-16. At the first and last session, participants complete the Army Physical Readiness Test. All other sessions consist of: Warm-up; Walk/Run; 2 HICRT circuits with 3 sets of 3-4 exercises; 1-2 min jump rope and 4-min power series between HICRT segments; Drills & Skills; and Cool-down/stretch.
16014263|NCT02780557|Behavioral|Book Provision Control|Caregivers will be provided with 6 picture books. They will not be trained to read with their child. They will receive information from other sources (e.g. health visitors and Book Start schemes) as normal.
16014226|NCT02780739|Behavioral|Active Control|The active control condition consists of 2 tasks (change detection and visual search) with 3 variants each. This intervention includes 48 70-min sessions (56 hrs) completed over 16 weeks: 3/wk. The 6 tasks are played in random order for 10 min each session.
16014227|NCT02780739|Device|active tDCS|Active HD-tDCS is administered during the first 30 minutes of each Mind Frontiers session. Therefore, the schedule is 20 30-min sessions (10 hrs) completed over 12 weeks: 1/wk weeks 5-8, 2/wk weeks 9-16. The HD-tDCS devices are Soterix Medical 2x2 models, using 4 electrodes (2 anodal and 2 cathodal). Electrodes are held in place with custom, 3D-printed electrode holders inserted into EEG caps, using EEG gel. Participants receive 2.0 mA current for 30 min, split over the 2 anodal electrodes, each drawing ≤1.0 mA. Stimulation is ramped up and ramped down over 30 sec at the beginning and end of the 30-min stimulation period.
16014228|NCT02780739|Device|sham tDCS|Sham HD-tDCS is administered during the first 30 minutes of each Mind Frontiers session. Therefore, the schedule is 20 30-min sessions (10 hrs) completed over 12 weeks: 1/wk weeks 5-8, 2/wk weeks 9-16. The HD-tDCS devices are Soterix Medical 2x2 models, using 4 electrodes (2 anodal and 2 cathodal). Electrodes are held in place with custom, 3D-printed electrode holders inserted into EEG caps, using EEG gel. Participants do not receive sustained stimulation; it is ramped up and ramped down over 30 sec at the beginning and end of the 30-min stimulation period to elicit the sensation of simulation and make the sham condition more convincing.
16014229|NCT02780739|Behavioral|Cognitive Training - 20 sessions|Mind Frontiers cognitive training software (Aptima Inc.) is a Wild West-themed Android application played on Nexus 10 tablets. This intervention includes 20 70-min sessions (23.33 hrs) completed over 12 weeks: 1/wk weeks 5-8, 2/wk weeks 9-16. The 6 mini-games, played in random order for 10 min each session, are Ante Up (Tower of London, executive functioning); Irrigator (visuospatial reasoning); Pen 'Em Up (dual task switching, executive function); Supply Run (Keep Track, working memory updating); Riding Shotgun (visuospatial working memory); and Sentry Duty (dual n-back, working memory). There is also a meta-game in which players build a town using resources earned from the mini-games, played for 5 min each session.
16014230|NCT02780726|Drug|roxadustat|Oral
16014231|NCT02780713|Drug|AZD9496 (Reference)|AZD9496 (Reference)
16014232|NCT02780713|Drug|AZD9496 Variant A|AZD9496 Variant A.
16014233|NCT02780713|Drug|AZD9496 Variant B|AZD9496 Variant B
16014234|NCT02780713|Drug|AZD9496 Variant C|AZD9496 Variant C
16014235|NCT02780713|Drug|AZD9496 Variant D|AZD9496 Variant D
16014236|NCT02780700|Drug|Nintedanib|
16014237|NCT02780700|Drug|Capecitabine|
16014238|NCT02780687|Drug|Afatinib|
16014239|NCT02780674|Biological|MEDI7734|Three subjects (cohort 1) and six subjects (cohort 2-5) will receive MEDI7734 for a total of 27 subjects.
16014240|NCT02780674|Biological|Placebo|One subject (cohort 1) and two subjects (cohort 2-5) will receive placebo, for a total of 9 subjects.
16014241|NCT02780661|Device|Denture Cleanser Daily Use Period|One denture cleansing tablet will be soaked in a cup of very warm water (150 ml) with dentures for Day 0 to Day 7 for 15 mins. Brush dentures for 30 seconds using the solution, rinse under running water for 10 seconds.
16014242|NCT02780661|Device|Denture Cleanser Weekly Use Period|One denture cleansing tablet will be soaked in cup of very warm water (150 ml) from Day 0 to Day 6 for 15 mins; and in cup of very warm water (150 ml) with 1 denture cleansing tablet on Day 7 at site for 15 mins. Brush dentures for 30 seconds using the solution, rinse under running water for 10 seconds.
16014243|NCT02780661|Other|Water|A cup of very warm water will be used to soak one denture cleansing tablet and dentures for per day (Day 0 to Day 7) or weekly (Day 0 and Day 7) treatment regimen.
16014244|NCT02780648|Radiation|Stereotactic Body Radiation|
16014245|NCT02780635|Behavioral|Mobile App + Mailed Materials for managing stress associated with PTSD|"PTSD Coach and PTSD Family Coach mobile apps plus mailed Couples Coach intervention materials and discussion board added to PTSD Family Coach app"
16014246|NCT02780635|Behavioral|Mobile App for managing stress associated with PTSD|PTSD Coach and PTSD Family Coach mobile apps
16014247|NCT02780622|Drug|Oseltamivir|Oseltamivir 75 mg orally, twice daily for 4 days and once on Day 5.
16014248|NCT02780622|Drug|Warfarin|Warfarin once daily, at a dose determined through titration by participants' usual hematologist.
16014249|NCT02780609|Drug|Selinexor|Selinexor will be given orally 2 to 3 hours prior to high dose-melphalan IV infusion. Phase I: Dose escalation beginning with 40 mg to determine the recommended Phase II dose (RPh2D). Phase II: Treatment at RPh2D.
16014250|NCT02780609|Drug|Melphalan|Melphalan 100 mg/m^2 IV over 30-45 minutes.
16014251|NCT02780609|Drug|Dexamethasone|Dexamethasone 20 mg PO (or IV) daily (on days -3, -2 and -1).
16014252|NCT02780609|Procedure|Autologous Hematopoietic Cell Transplantation (HCT)|Participant's own stem cells are collected from their blood, frozen, then given back to them after chemotherapy.
16014253|NCT02780609|Drug|Fosaprepitant|Fosaprepitant at 150 mg IV on days -3 and -2.
16014254|NCT02780596|Other|Item1|Does CHILD NAME often wake one or more times during the night?
16014255|NCT02780596|Other|Item2|Does CHILD NAME often wake one or more times per night, and does and adult go to him/her?
16014256|NCT02780596|Other|Item3|Do you think CHILD'S SLEEP is a problem?
16014257|NCT02780596|Other|Item4|Do you think CHILD NAME has a sleep problem?
16014258|NCT02780596|Other|Item5|Do you have any concerns about CHILD NAME'S sleep?
16014259|NCT02780583|Drug|kineret|anakinra administered subcutaneously every 6 hours x 72 hours along with intravenous methylprednisolone
16014260|NCT02780583|Drug|placebo|placebo injection administered every 6 hours along with intravenous methylprednisolone
16014261|NCT02780570|Procedure|Small Volume Plasma Exchange|Six sessions will be done daily for consecutive 8 days (total 48 sessions). 7 ml/body weight blood will be drawn at each session and will be separated into plasma and blood cells. Blood cells will be infused back to the patients and plasma will replaced by equal volume of fresh frozen plasma and colloid solution. At the end of each day 1200 ml plasma (total 9600 ml in 48 sessions) will be removed.
16014262|NCT02780557|Behavioral|Contingent Reading Intervention|Caregivers will be provided with 6 picture books. They will be trained to use contingent talk when looking at picture books with their infants. They will be asked to spend 10 mintues each day engaging in contingent talk while looking at picture books. The intervention will run for 4 months. Parents will be asked to keep a daily reading diary.
16081785|NCT02295280|Drug|Codeine|PO
16014265|NCT02780544|Device|incubator|staying in incubator during eye examination.
16014266|NCT02780544|Drug|Sucrose|oral sucrose before eye examination
16014267|NCT02780518|Device|Airvo|Applying high flow nasal oxygen
16014268|NCT02780505|Drug|vitamin c|"In the current prospective, double-blind, and randomized trial, 66 patients with peritoneal dialysis were enrolled, and 43 patients were detected with serum vitamin C level below 4 μg/ml to determine the effect of vit C on anemia in patients on CAPD.
~The measured clinical parameters including plasma vitamin C level, hemoglobin (Hb), Ferritin, total iron-binding capacity (TIBC), serum Fe, C-reactive protein (CRP), and transferrin saturation. Consumption of vitamin supplements such as vitamin C (or any other form of it) either oral or parenteral were discontinued three weeks before collecting the samples."
16014269|NCT02780505|Drug|placebo|"Active (ascorbic acid 250 mg) and placebo (same weight of starch) tablets were similar in shape and size for both study and control groups. Intravenous intervention was not advantageous for hemodialysis subjects and it was impossible for PD patients, therefore, oral administration was used. All follow-up records were stored.
~The erythropoietin (EPO) injections was prescribed for each patient in weekly dose, started one month before collecting blood samples for vitamin C measurement."
16014270|NCT02780492|Other|Set of assessment tools|
16014271|NCT02780479|Drug|Dexamethasone|at 24 hours from the first Dexamethasone dose given in ED.
16014272|NCT02780479|Drug|Prednisone|at 24 hours from the first Dexamethasone dose given in ED.
16014273|NCT02780453|Device|Negative pressure dressing|
16014274|NCT02780453|Device|Standard wound dressing|
16014275|NCT02780440|Behavioral|Traditional Home Based Exercise Program|Subjects in the control group will receive a traditional home Occupational Training exercise program as per conventional OT guidelines with the same home program duration.
16014276|NCT02780440|Behavioral|Unimanual Home Based Mirror Therapy Program|The affected hand will remain still in the mirror box, the unaffected hand will perform the exercises while the subject watches the mirror reflection.
16014277|NCT02780440|Behavioral|Bimanual Home Based Mirror Therapy Program|The affected hand in the mirror box will best mimic the unaffected hand, while also watching the mirror reflection.
16014278|NCT02780427|Drug|intranasal dexmedetomidine|"Phase 1, Children received a bolus of intranasal dexmedetomidine which adjusted by the Dixon up-and-down method for TEE study. The first child received 2.5 mcg/kg of intranasal dexmedetomidine dose (100mcg/ml), and the dose varied by 0.1 mcg/kg according to the up-and-down method Phase 2 was a dose-escalation study. After interim analysis of the phase 1 results, four dose levels above the calculated ED50 were defined. Dose spacing was set at 0.25 mcg/kg of intranasal dexmedetomidine consistent with the re-estimated standard deviation (SD)."
16014279|NCT02780401|Other|Laboratory Biomarker Analysis|Correlative studies
16014280|NCT02780401|Biological|pUMVC3-IGFBP2-HER2-IGF1R Plasmid DNA Vaccine|Given ID
16014281|NCT02780401|Biological|Sargramostim|Given ID
16014282|NCT02780388|Drug|VIB4920|Participants will receive a single IV dose of VIB4920 Q2W from Day 1 up to 12 weeks.
16014283|NCT02780388|Other|Placebo|Participants will receive a single IV dose of placebo matched to VIB4920 Q2W from Day 1 up to 12 weeks.
16014284|NCT02780375|Procedure|Blood donation during radiotherapy|Participants will be asked to donate a blood sample at 5 time points before and during their radiotherapy
16014285|NCT02780362|Drug|Prodactariv|1 tablet contains 60 mg Daclatasvir
16014286|NCT02780362|Drug|Clatazev|1 tablet contains 60 mg Daclatasvir
16014287|NCT02780349|Device|WIRION|Embolic Protection System
16014288|NCT02780336|Other|No intervention.|Participants will complete questionnaires and interviews as well as have a neurological exam that will be video recorded. For this exam they will do simple movements (like looking at the camera, squeezing your eyes closed, moving your head, and writing).
16014289|NCT02780323|Drug|CELBESTA®|1 tablet of CELBESTA® and 1 tablet of CELEBREX® placebo, twice daily for 6 weeks
16014290|NCT02780323|Drug|CELEBREX®|1 tablet of CELEBREX® and 1 tablet of CELBESTA® placebo, twice daily for 6 weeks
16014291|NCT02780323|Drug|CELEBREX® placebo|1 tablet of CELBESTA® and 1 tablet of CELEBREX® placebo, twice daily for 6 weeks
16014292|NCT02780323|Drug|CELBESTA® placebo|1 tablet of CELEBREX® and 1 tablet of CELBESTA® placebo, twice daily for 6 weeks
16014293|NCT02780310|Drug|Lenvatinib|
16014294|NCT02780284|Behavioral|Physical activity intervention|150 minutes per week of moderate intensity cardiovascular exercise
16014295|NCT02780271|Behavioral|In-person education|Four in-person hands-on nutrition and physical activity education classes and cooking sessions.
16014296|NCT02780271|Behavioral|E-communication|11 months of motivational text messages, emailed newsletters, and access to a website.
16014297|NCT02780271|Behavioral|Control|Written guidelines on diet and physical activity for breast cancer survivors, a pedometer to encourage physical activity, and a brief verbal overview of diet and physical activity guidelines for cancer survivors.
16014298|NCT02780258|Device|Restylane Silk|
16014299|NCT02780245|Drug|Tranexamic Acid|At 20 minutes preoperatively, TXA of 20 mg/kg was administered in Z Solution (500•0 ml normal saline containing a prophylactic antibiotic 1•0 g).
16014300|NCT02780245|Procedure|Intraoperative Uterine Cooling|Intraoperatively immediately following delivery of the fetus the uterus was been externalized in the usual fashion, and the body of the uterus cephalad to the hysterotomy incision was been wrapped in sterile surgical towels saturated in sterile and iced normal saline. These towels came from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels was been kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
16014301|NCT02780232|Behavioral|Cuida tu animo / Care for your mood|"CUIDA TU ÁNIMO is an online program to adolescents that provides information, education and support related to the care of the mood.
~Adolescents interact with the program via a monitoring e-mail that they receive every two weeks (Monitoring) and a website which allows them to access a number of links. The website have the following modules:
~What is 'CUIDA TU ÁNIMO': Description and definition of the program
~Psycho-educational information: Information about depression, its treatment, and opportunities for prevention
~How is your mood? (Monitoring): a) Online assessment of symptoms every two weeks during three months with the PHQ-3. b) Feedback
~Forums.
~Blog.
~Appointment (Chat or Phone call).
~Contact."
16014368|NCT02779777|Drug|Tipifarnib|900 mg b.i.d. Days 1 -7, 15-21 in 28-day cycle
16014302|NCT02780219|Other|stable amino acid infusion|stable isotopes Such as L-[ring-13C6]-Phenylalanine, L-[ring-D4]Tyrosine, L-[Methyl-D3]Tau-Methylhistidine, trans-[2,5,5-D3]4-Hydroxy-L-proline, L-[Guanido-15N2]-Arginine, L-[4,4,5,5-D4-5-13C]Citruline, L-13C5 -Ornithine, L-15N2-Glutamine, L-[1,2-13C2]Glutamic Acid, 1-13C-Glycine, L-15N3-Histidine, L-13C6-Leucine, L-[methyl-D3]Methionine, α-1-13C-ketoisocaproic acid, L-1-13C-Methionine, DL-[3,3,4,4-D4]Homocysteine, L-[1,2-13C2]Taurine, L-(Indole-D5)Tryptophan, 13C-Urea, L-1-13C-Isoleucine, L-13C5-Valine, α-[Dimethyl-13C2]ketoisovaleric acid, 2-keto-3-methyl-13C6-pentanoate, 3-hydroxy-[3,4-methyl-13C3]isovaleric acid, 13C3-glycerol is given IV simultaneously
16014303|NCT02780219|Other|acute exercise with amino acid infusion|resistance exercise of each limb (i.e., leg (right/left); arm (right/left) on an isokinetic exercise machine allowing control of velocity, force, etc. with stable isotopes such as L-[ring-13C6]-Phenylalanine, L-[ring-D4]Tyrosine, L-[Methyl-D3]Tau-Methylhistidine, trans-[2,5,5-D3]4-Hydroxy-L-proline, L-[Guanido-15N2]-Arginine, L-[4,4,5,5-D4-5-13C]Citruline, L-13C5 -Ornithine, L-15N2-Glutamine, L-[1,2-13C2]Glutamic Acid, 1-13C-Glycine, L-15N3-Histidine, L-13C6-Leucine, L-[methyl-D3]Methionine, α-1-13C-ketoisocaproic acid, L-1-13C-Methionine, DL-[3,3,4,4-D4]Homocysteine, L-[1,2-13C2]Taurine, L-(Indole-D5)Tryptophan, 13C-Urea, L-1-13C-Isoleucine, L-13C5-Valine, α-[Dimethyl-13C2]ketoisovaleric acid, 2-keto-3-methyl-13C6-pentanoate, 3-hydroxy-[3,4-methyl-13C3]isovaleric acid, 13C3-glycerol is given IV simultaneously
16014304|NCT02780219|Other|24-hour post exercise amino acid infusion|stable isotopes such as L-[ring-13C6]-Phenylalanine, L-[ring-D4]Tyrosine, L-[Methyl-D3]Tau-Methylhistidine, trans-[2,5,5-D3]4-Hydroxy-L-proline, L-[Guanido-15N2]-Arginine, L-[4,4,5,5-D4-5-13C]Citruline, L-13C5 -Ornithine, L-15N2-Glutamine, L-[1,2-13C2]Glutamic Acid, 1-13C-Glycine, L-15N3-Histidine, L-13C6-Leucine, L-[methyl-D3]Methionine, α-1-13C-ketoisocaproic acid, L-1-13C-Methionine, DL-[3,3,4,4-D4]Homocysteine, L-[1,2-13C2]Taurine, L-(Indole-D5)Tryptophan, 13C-Urea, L-1-13C-Isoleucine, L-13C5-Valine, α-[Dimethyl-13C2]ketoisovaleric acid, 2-keto-3-methyl-13C6-pentanoate, 3-hydroxy-[3,4-methyl-13C3]isovaleric acid, 13C3-glycerol is given IV simultaneously
16014305|NCT02780206|Other|Stable isotope amino acid infusion|such as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline
16014306|NCT02780193|Drug|Omegaven|Therapy with Omegaven® will be initiated and maintained at 1 g/kg/day. It will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition. If additional non-protein calories are needed, they will be provided as carbohydrates. No other parenteral form of fat emulsion will be used during Omegaven® therapy.The Omegaven® dose may be discontinued if the subject is receiving adequate enteral nutrition to meet metabolic and growth needs.
16014307|NCT02780180|Drug|QGC001|
16014308|NCT02780180|Drug|Placebo|Lactose capsule manufactured to mimic QGC001 50 mg and 250 mg
16014309|NCT02780167|Drug|PF-04965842|10 mg of PF-04965842 QD for 12 weeks
16014310|NCT02780167|Drug|PF-04965842|30 mg of PF-04965842 QD for 12 weeks
16014311|NCT02780167|Drug|PF-04965842|100 mg of PF-04965842 QD for 12 weeks
16014312|NCT02780167|Drug|PF-04965842|200 mg of PF-04965842 QD for 12 weeks
16014313|NCT02780167|Drug|Placebo|Placebo QD for 12 weeks
16014314|NCT02780154|Biological|PfSPZ (7G8) Challenge|PfSPZ (7G8) is a candidate vaccine, it consists of a suspension of purified, live-attenuated cryopreserved Pf sporozoites in a cryoprotectant.
16014315|NCT02780154|Biological|PfSPZ (NF54) Challenge|PfSPZ (NF54) is a candidate vaccine, it consists of a suspension of purified, live-attenuated cryopreserved Pf sporozoites in a cryoprotectant.
16014316|NCT02780141|Drug|roxadustat|Oral
16014317|NCT02780128|Procedure|Biopsy|Needle or incisional tumor biopsy
16014318|NCT02780128|Genetic|Next Generation Sequencing|Tumor tissue will be sent to Foundation Medicine laboratory for molecular profiling.
16014319|NCT02780128|Procedure|Tumor Scans|Participants will undergo different types of scans to look at your tumor. These scans include CT (computerized tomography), MIBG (meta-iodobenzylguanidine) PET (positron emission tomography), and MRI (magnetic resonance imaging). Participants may have more than one type of scan.
16014320|NCT02780128|Procedure|Bone marrow Tests|Participants will have needles inserted through their hip bone to remove fluid from inside the bone marrow. This test determines if participants have tumor in the bone marrow.
16014321|NCT02780128|Other|Physical Exam|The exam includes taking participant weight, height, blood pressure, heart rate and respiratory rate and performing a examination of the participants body. The investigators may also check the participants vision with an eye chart.
16014322|NCT02780128|Other|Eye Exam|Participants will have their eyes will be evaluated using different instruments. Participants will also be asked to read an eye chart. The exams will take about 15 minutes.
16014323|NCT02780128|Other|Labs|Standard blood tests will be done to measure different types of blood cells, to measure the amount of certain substances, and tests to check how well liver and kidneys are working. When possible, the investigators will take blood from the participants central line. If this is not possible, the investigators will take blood from a vein in the participants arm. First, the investigators will put some cream on the skin so that drawing blood will not be painful. Then the investigators will put a thin needle into the vein to draw the blood.
16014324|NCT02780128|Other|Pregnancy Test|If the participant is 11 years old or older or has already started having periods, the participant will be asked to take a pregnancy test before starting this study. The results will be shared with the participant but not with the participants' parent(s). We strongly encourage the participant to share the results with the parents. If the participant is found to be pregnant, the participant will not be able to continue participation in the study. About 1 teaspoon of blood (or urine if a urine test) will be needed.
16014325|NCT02780128|Behavioral|Interviews|A team member will take the participant's medical history, along with a listing of any medications that are being taken. Throughout the study, participants will be asked to report if they think that anything bad has happened as a result of the study.
16014326|NCT02780128|Other|ECG|This is a test of electrical activity of the heart. The investigators will put electrodes (sticky pads attached to wires) on the participant's chest, arms and legs. The electrocardiogram (ECG) will not be uncomfortable, but the participant will have to lie still. It does not hurt and takes about 15 minutes.
16014327|NCT02780128|Other|Echocardiogram|The participant will have an ultrasound of the heart taken to assess heart function. The investigators will put some gel on the skin and use a machine to take pictures of the heart.
16014328|NCT02780128|Drug|Ribociclib|Participants will take ribociclib once per day orally for Days 1-21 of a 28-day cycle.
16014369|NCT02779764|Drug|roxadustat|Oral
16014329|NCT02780128|Drug|Ceritinib|Participants will take ceritinib once per day orally for 28 days of a 28-day cycle.
16014330|NCT02780115|Drug|AGN-199201 ophthalmic solution|1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.
16014331|NCT02780115|Drug|AGN-190584 ophthalmic solution|1 drop of AGN-190584 ophthalmic solution Doses A, B, C in the eye.
16014332|NCT02780115|Drug|AGN-199201 Vehicle|Vehicle to AGN-199201
16014333|NCT02780115|Drug|AGN-190584 Vehicle|Vehicle to AGN-190584
16014334|NCT02780102|Other|Cognitive-Motor Rehabilitation|Cognitive-Motor Rehabilitation (CMR) group received 20 sixty-minute sessions of cognitive-motor exercises
16014335|NCT02780102|Drug|Ritalin|2 or 3 doses of 10 mg tablets of immediate-release Methylphenidate (Ritalin) per day for 8 week.
16014336|NCT02780102|Other|Active Control|Active Control group simultaneously received 20 sixty-minute sessions of low dose cognitive-motor exercises
16014337|NCT02780076|Other|Functional training program|Patients treated for hip fracture participate in a functional training program during their short-term stays at nursing homes. The program is initiated by the nurses 4 times a day for 3 weeks as part of the habitual routine.
16014338|NCT02780063|Other|Lenstar Biometer|uses optical principles (laser interferometry) to measure axial length, measuring distance from the corneal apex to the retinal RPE. In addition to axial length, it also measures corneal thickness, anterior chamber depth, lens thickness, radii of curvature of flat and steep meridian, axis of flat meridian, white to white distance, and pupil diameter.
16014339|NCT02780050|Other|core muscle activation using physical fitness|"2 instructors, they had physical therapy (PT) certificate, take an exam for subject's muscle strength of each muscle. After that time, subjects take a rest for 10 minutes. Researchers educate to subjects for high quality CPR including 5 to 6cm compression depth, 100 to 120 beat per minute (bpm) rate, complete chest recoil. Subjects perform chest compression to manikin with skill reporting system during 4min under guidance of 110 bpm metronome sound (first chest compression). After 1st chest compression, subjects take a rest during an hour and carry out PT. PT consist of 30 second plank for 3 sets, 12 times bridge for 3 sets and 20 times leg extension for 3 sets. Subjects take a rest during 30 seconds between sets, 1 minute every 3 sets.
~After PT completion, subjects take a rest during 10 minutes, and then perform 2nd chest compression in the same way of 1st chest compression. Researchers record subject's chest compression depth and rate in 1st and 2nd chest compression."
16014340|NCT02780037|Behavioral|Regulatory frame: prevention|Exercise program presented as preventing deterioration.
16014341|NCT02780037|Behavioral|Regulatory frame: promotion|Exercise program presented as promoting improvement.
16014342|NCT02780037|Behavioral|Regulatory frame: not implied|Exercise program presented without implied consequences.
16014343|NCT02780024|Drug|Metformin|Metformin,
16014344|NCT02780011|Drug|Brentuximab Vedotin|Antibody-drug conjugate composed of the anti-CD30 chimeric immunoglobulin G1 monoclonal antibody cAC10 and the antimicrotubule drug monomethyl auristatin E connected by a protease-cleavable linker.
16014345|NCT02780011|Drug|Alsertib|Aurora A kinase inhibitor
16014346|NCT02779998|Other|non invasive ventilation|non invasive ventilation is delivered by a specific respirator with inspiratory help mode. NIV mask and parameters are adapted to obtains a Tidal volume ≤ to 8 ml/kg/cycle (if possible ≤ 6 ml/kg/cycle) and a SpO2 superior of 94%.
16014347|NCT02779998|Other|Standard oxygen therapy with facial mask|
16014348|NCT02779985|Dietary Supplement|Lycium Barbarum mixed meal|This mixed meal contains 25 grams of dried Lycium Barbarum (Goji berry, Wolfberry)
16014349|NCT02779985|Dietary Supplement|Control mixed meal|This mixed meal does not contain Lycium Barbarum, but is matched for energy and macronutrient content
16014350|NCT02779972|Other|Echo stress test|Echo stress test
16014351|NCT02779959|Drug|Prochlorperazine|
16014352|NCT02779946|Device|Fibro Scan|
16014353|NCT02779946|Genetic|PNPLA3|
16014354|NCT02779933|Other|Epidemiology od HAP|no intervention
16014355|NCT02779920|Procedure|per oral pylorotomy|The procedure is endoscopic pylorotomy. The standard procedure consists in the realization of a longitudinal incision of 2 cm at the anterior surface of the gastric antrum at 5 cm from the pylorus after a submucosal injection of a solution containing 85% saline 10% glycerol and 5% fructose. This longitudinal incision serve as an input for producing a submucosal tunnel dissected fibers gastric submucosa step. The internal circular of the pyloric muscle is then severed fiber after fiber over its entire length and its entire thickness. Once the pyloric section completed, the tunnel inlet will be closed by means of hemostatic clips.
16014356|NCT02779907|Other|No Intervention|No interventions planned for this observational study
16014357|NCT02779894|Other|Remote control of patients|Diagnosis outside the hospital (3 Home PR) CPAP (if needed) titration at home REmote control of patient's during 3 months by video or phonoconference
16014358|NCT02779881|Dietary Supplement|Extensively hydrolyzed casein formula plus LGG|
16014359|NCT02779868|Dietary Supplement|Omega-3|patients included in this group will take 2g (4 capsules) per day of eicosapentaenoic acid.
16014360|NCT02779868|Dietary Supplement|Olive oil|patients included in this group will take 4 capsules per day of olive oil.
16014363|NCT02779842|Drug|Coppertone (BAY 987517)|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. formulation number SR15-39-Z12-002.
16014364|NCT02779829|Drug|Coppertone (BAY 987517)|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. Formulation number SR15-40-Z12-006.
16014365|NCT02779816|Device|Pen device|Adaptive pen device
16014366|NCT02779803|Procedure|EC-IC bypass|To determine if cerebral revascularization via STA to MCA bypass to improve cerebral hemodynamics, cognitive function, and quality of life in a defined subgroup of symptomatic carotid occlusion patients.
16014367|NCT02779790|Other|Liquid Meal Replacements|An intervention that contains a mixture of protein, carbohydrate, and fat, along with added vitamins and minerals in liquid ready-to-drink or powder formulas that require mixing.
16084819|NCT02273297|Other|Maternal factors|
16014371|NCT02779751|Drug|Pembrolizumab|Administered IV
16014372|NCT02779751|Drug|Anastrozole|Administered orally
16014373|NCT02779738|Drug|Merestinib|Administered orally
16014374|NCT02779725|Behavioral|SCC|Automated self-management coaching paired to symptom reports during daily symptom monitoring call
16014375|NCT02779725|Behavioral|Nurse Practitioner|Alerts generate if a patient reports symptoms above pre-set thresholds during daily symptom reporting calls . These alerts are monitored and follow up is given by a Nurse Practitioner.
16014376|NCT02779725|Behavioral|DSS|A Clinical Decision Support System (DSS), based on evidenced based guidelines, will be used to assist the nurse practitioner in follow up to symptom alerts.
16014377|NCT02779725|Behavioral|AT|An activity tracker will be provided to evaluate its use, acceptability and impact on fatigue severity. The purpose of providing the activity tracker is to extend the self-management coaching intervention given when participants report fatigue and receive coaching about exercise as part of the intervention.
16014378|NCT02779725|Behavioral|Symptom Severity|Automated patient-reporting of 11 common cancer treatment symptoms
16014379|NCT02779712|Procedure|Remote ischaemic conditioning|1 dose (=4 cycles) of intermittent upper limb ischaemia (1 cycle = 5minutes inflation to 20mmHg above systolic BP, 5 minutes deflation). Dose escalation: (i) Recruits 1-20 receive this cycle once (ii) Recruits 21-40 receive a second dose of 4-cycles one hour after the first. (iii) Recruits 41-60 receive further dosing, twice daily until day 4.
16014380|NCT02779712|Procedure|Sham|4 cycles of intermittent sham procedure (1 cycle = 5 minutes inflation to 30 mmHg, 5 minutes deflation), matching the dose escalation described in the intervention
16014381|NCT02779699|Drug|AL2846|AL2846 p.o. qd
16014382|NCT02779673|Other|Yoghurt drink containing plant stanol as esters|
16014383|NCT02779673|Other|Yoghurt drink without plant stanol as esters|
16014384|NCT02779660|Procedure|Remote ischemic preconditioning (RIPC)|RIPC will be induced by the application of 3 short episodes (5 minutes) of forearm ischemia by cuff sphygmomanometer inflation separated by 5 minutes of reperfusion.
16014385|NCT02779660|Procedure|sham-intervention|In the control group the cuff will be inflated for 3 times at 10 mm Hg for 5 minutes with 5-minute intervals
16014386|NCT02779647|Behavioral|The intervention consisted of physical activity based on play|The intervention consisted of physical activity based on play, with four 90-minute sessions per week for nine months (the school year). The total of sessions was 144, the minimum number of sessions to consider valid that a child has completed the intervention was 115 (80%) in order to perform the minimum level of physical activity recommended for their ages. In parallel, twice-monthly theoretical and practical sessions of nutritional advice were given to the children and their families. The study group performed the physical activity and received the nutritional advice, while the control group received only the theoretical and practical sessions on nutrition.
16014387|NCT02779634|Drug|ubiquinol|Ubiquinol three times daily
16014388|NCT02779634|Drug|Placebo|Sugar pill three times daily
16014389|NCT02779621|Procedure|Self-collecting a vaginal sample with a swab for HPV testing|The vaginal sample self-collected with the Floq swab will be tested for Human Papillomavirus (HPV) using Abbott RealTime PCR assay.
16014390|NCT02779621|Procedure|Collection of cervical sample for routine cervical screening|This is the routine cervical screening test available to the public through the NHS. This sample is collected by a clinician (usually a Practice Nurse)
16014391|NCT02779608|Drug|intraperitoneal docetaxel|One peritoneal access port will be implanted in subcutaneous space of patients' abdominal wall after laparoscopic exploration.Then intraperitoneal docetaxel in 1litre normal saline will be administered through the port
16014392|NCT02779608|Drug|oral S-1|40mg/m² twice daily on day 1-14 every 3 weeks
16014393|NCT02779595|Other|Perioperative pulmonary function tests|Pulmonary electrical impedance tomography, spirometry, pulse oximetry and query performed preoperatively, at the the third, fifth and seventh postoperative day
16014394|NCT02779582|Drug|Oral Micronized Progesterone|The dose of 300 mg of Progesterone is a physiological one that maintains the serum progesterone at or above the luteal (normal post-ovulatory) threshold for 24 hours. This duration of action is important because Progesterone is not safely taken during waking hours because of its soporific effects.
16014395|NCT02779582|Drug|Placebo|pill with no effect
16014396|NCT02779569|Drug|decitabine|
16014397|NCT02779556|Other|ACP Living with Diabetes Guide|American Colleges of Physicians (ACP) Living Well with Diabetes Guide
16014398|NCT02779556|Other|ADA Living Well with Diabetes Workbook|American Diabetes Association (ADA) Living Well with Diabetes Workbook
16014399|NCT02779543|Device|Fitbit|Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine. Willing subjects, after providing informed consent, will be fitted with one of the three aforementioned sleep monitoring devices (randomly assigned) on the wrist of their non-dominant hand when prepared for the sleep study by a technician.
16014400|NCT02779543|Device|Jawbone UP|Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine. Willing subjects, after providing informed consent, will be fitted with one of the three aforementioned sleep monitoring devices (randomly assigned) on the wrist of their non-dominant hand when prepared for the sleep study by a technician.
16014401|NCT02779543|Device|Microsoft Band|Subjects will be recruited from those patients attending a regularly scheduled overnight PSG sleep study at the Weill Cornell Medical College Center for Sleep Medicine. Willing subjects, after providing informed consent, will be fitted with one of the three aforementioned sleep monitoring devices (randomly assigned) on the wrist of their non-dominant hand when prepared for the sleep study by a technician.
16014402|NCT02779530|Drug|Diclofenac|50 mg po, b.i.d for 6 days
16014403|NCT02779530|Other|Placebo|Placebo po, b.i.d. for 6 days
16014404|NCT02779517|Other|Mobile Service Robot Survey|The goal is to build a low-cost mobile service robot that will focus on the simple, but key, repetitive, data-driven tasks that robots do well. Rather than attempt to create a robot helper that mimics humans, the goal is to free human caregivers from the time-consuming tasks that robots can accomplish with facility, thereby allowing humans to focus on tasks that humans do best (i.e. human contact).
16014500|NCT02778854|Genetic|detection of driver mutation|participants are received gene detection via the liquid biopsy
16086128|NCT02263976|Drug|Spiriva|
16014405|NCT02779517|Other|Mobile Service Robot Survey for Patients|The goal is to build a low-cost mobile service robot that will focus on the simple, but key, repetitive, data-driven tasks that robots do well. Rather than attempt to create a robot helper that mimics humans, the goal is to free human caregivers from the time-consuming tasks that robots can accomplish with facility, thereby allowing humans to focus on tasks that humans do best (i.e. human contact). This survey differs in terms of design questions.
16014406|NCT02779491|Behavioral|5-a-day fruit and vegetable mobile phone application|5-a-day fruit and vegetable mobile phone application
16014408|NCT02779465|Drug|Vitamin D3|Participants with chronic hepatitis B will take 800 IU of vitamin D3 per day by mouth besides the anti-virus treatment with nucleos(t)ide medicine
16014409|NCT02779439|Biological|Virus specific CTLs|Virus specific CTLs will be given to patients with persistent or recurrent viral reactivation after 2 weeks of standard anti-viral therapy
16014410|NCT02779426|Behavioral|Text messages|Daily text messages with information about atopic dermatitis and treatment reminders.
16014411|NCT02779413|Drug|insulin degludec|Patients will be treated with commercially available Tresiba® FlexTouch® according to routine clinical practice at the discretion of the treating physician.
16014412|NCT02779400|Device|Self testing INR device|the procedure involves a series of repeated measurements of INR with the studied device
16014413|NCT02779387|Drug|Goserelin Acetate|
16014414|NCT02779374|Other|Autologous bone marrow transplantation|Bone marrow aspiration of 10 ml/kg is done from the posterior iliac crest. The sample is put in sterile container with appropriate amount of heparin then filtered to remove bone spicules, fat, and cellular debris. The filtered sample is injected unprocessed in a peripheral vein. The process is done once.
16014415|NCT02779361|Dietary Supplement|Green tea|"Lipton pure green tea, 5 teas on the first 6 days, and 9 teas on the day 7. Teas will be ingested at 08:00 am, 10:30 am, 13:00 pm, 15:30 pm, 18:00 pm days 1-6, and 08:00 am (*), 10:30 am, 13:00 pm (*), 15:30 pm, 18:00 pm (*), 20:30 pm on day 7.
~One bag of tea will be used to prepare the beverages with exception of some beverages on day 7 that will be prepared with two bags (*)."
16014416|NCT02779348|Drug|BIA 3-202|Nebicapone tablets 200 mg
16014417|NCT02779348|Drug|warfarin|Varfine® 5 mg (warfarin 5 mg) tablets
16014418|NCT02779335|Other|Enteral Formula|pediatric subjects will be fed a standard pediatric enteral formula tube feeding
16014419|NCT02779322|Procedure|Minigastric bypass|The patient will be submitted to a minigastric bypass at the time of the operation
16014420|NCT02779322|Procedure|Gastric bypass|In this case a simplified conventional gastric bypass will be performed
16014421|NCT02779309|Procedure|Home Care/RAI-HC Assessment|Home care recipients who have received a comprehensive health assessment using the Resident Assessment Instrument for Home Care (RAI-HC).
16014422|NCT02779296|Other|2-Octyl Cyanoacrylate Glue|topical
16014423|NCT02779283|Drug|Cyclophosphamide|Given IV
16014424|NCT02779283|Drug|Cytarabine|Given IV
16014425|NCT02779283|Drug|Dasatinib|Given PO
16014426|NCT02779283|Drug|Dexamethasone|Given PO
16014427|NCT02779283|Drug|Doxorubicin Hydrochloride|Given IV
16014428|NCT02779283|Drug|Idarubicin|Given IV
16014429|NCT02779283|Drug|Idelalisib|Given PO
16014430|NCT02779283|Device|In Vitro Kinase Inhibitor Assay|Correlative studies
16014431|NCT02779283|Drug|Leucovorin Calcium|Given IV
16014432|NCT02779283|Drug|Methotrexate|Given IV
16014433|NCT02779283|Drug|Methylprednisolone Sodium Succinate|Given IV
16014434|NCT02779283|Drug|Ponatinib Hydrochloride|Given PO
16014435|NCT02779283|Biological|Rituximab|Given IV
16014436|NCT02779283|Drug|Ruxolitinib Phosphate|Given PO
16014437|NCT02779283|Drug|Sorafenib Tosylate|Given PO
16014438|NCT02779283|Drug|Sunitinib Malate|Given PO
16014439|NCT02779283|Drug|Vincristine Sulfate|Given IV
16014440|NCT02779270|Drug|BAY987518|"Apply the assigned test product to all sun-exposed areas of the face and body while avoiding contact with mouth, eyes and eyelids.
~Formulation: V27-104"
16014441|NCT02779270|Drug|Sunscreen Lotion (U77-030 Control)|Apply the assigned test product to all sun-exposed areas of the face and body while avoiding contact with mouth, eyes and eyelids.
16014442|NCT02779257|Drug|Pasireotide|Pasireotide will be used, in addition to diazoxide, as a medical treatment to blunt hypoglycemia in the setting of autonomous insulin secretion.
16014443|NCT02779257|Drug|Diazoxide|Pasireotide will be used, in addition to diazoxide, as a medical treatment to blunt hypoglycemia in the setting of autonomous insulin secretion.
16014444|NCT02779244|Procedure|Early Weight bearing + Cam Boot|Patients will be transitioned to weight bearing as tolerated in a cam boot.
16014445|NCT02779244|Procedure|Non-Weight Bearing + Cam Boot|Subject will be transitioned to non weight bearing cam boot, standard treatment.
16014446|NCT02779231|Other|Bi-directional texting|
16014447|NCT02779218|Procedure|Paired Associative Stimulation|Patient with Paired Associative Stimulation only
16014448|NCT02779218|Procedure|Paired Associative Stimulation + Motor Imagery exercises|Patient with Paired Associative Stimulation + Motor Imagery exercises
16014449|NCT02779218|Procedure|Placebo Paired Associative Stimulation + Motor Imagery exercises|Patient with placebo Paired Associative Stimulation + Motor Imagery exercises
16014450|NCT02779205|Procedure|adipose tissue sample|adipose tissue sample
16014451|NCT02779192|Drug|SPI-1005 200mg|Oral SPI-1005 capsules, 200 mg ebselen, twice daily, 7 days
16014452|NCT02779192|Drug|SPI-1005 400mg|Oral SPI-1005 capsules, 400 mg ebselen, twice daily, 7 days
16014453|NCT02779192|Drug|Placebo|Oral SPI-1005 capsules, 0 mg ebselen, twice daily, 7 days
16014454|NCT02779179|Procedure|Periodontal treatment|"Mechanical debridement (scaling, root planning, subgingival curettage)
~Antimicrobial therapy (systematically administered: amoxicillin or clindamycin).
~Antiseptic mouthrinses, gel or dentifrice
~Oral hygiene instructions (to educate and motivate patients to control the accumulation of plaque and calculus)"
16014455|NCT02779166|Drug|Celecoxib|Received 400mg celecoxib prior to surgery
16014456|NCT02779166|Drug|placebo|
16014501|NCT02778841|Other|Exercise|This study is designed to examine and comparing there intervention program on balance, mobility and knee proprioception among male elderly
16086292|NCT02262637|Drug|Micardis®|
16014457|NCT02779153|Drug|Acthar low dose (40 U)|The 40U group will administer 0.5 mL of study medication once a day. Patients will taper study medication during Week 2 through the remainder of the study and will administer 0.5 mL of study medication twice a week. The stable Acthar regimen should be maintained for the remainder of the study. However, dose adjustments may be implemented if needed based on safety.
16014458|NCT02779153|Drug|Acthar high dose (80 U)|The 80U group will administer 1.0 mL of study medication every day. If a patient meets dose reduction criteria, their assigned volume will be adjusted from 1.0 mL to 0.5 mL. Patients will taper study medication during Week 2 through the remainder of the study. However, dose adjustments may be implemented if needed based on safety.
16014459|NCT02779140|Biological|NTM-1632|Monoclonal antibody mixture of XB10, XB18, and XB23
16014460|NCT02779140|Other|Placebo|Placebo
16014461|NCT02779127|Other|Medical interrogatory|Cardiovascular risk, medical history, known pathologies and actual treatments are evaluated
16014462|NCT02779127|Other|Medical examination|Systolic blood pressure, diastolic blood pressure, cardiac frequency, pulse palpation, hearth and pulmonary auscultation
16014463|NCT02779127|Other|Specific bioassay|Exhaled carbon monoxide measure and nicotine in the urine are evaluated
16014464|NCT02779127|Other|Endothelial function evaluation|Endothelial function evaluation done by echotracking determining the basale flow mediated dilatation
16014465|NCT02779127|Other|General bioassay|Fasting bioassay evaluating total cholesterol, low density lipoproteins, high density lipoproteins, triglycerides, creatine, transaminases, gamma glutamyl transferases, fibrinogen, reactive protein C, blood count and sedimentation rate.
16014466|NCT02779114|Drug|Control group|Stable dosage of previous treatment with Decortin H®, Leflunomid (e.g. Arava®), Ciclosporin (e.g. Immunosporin®), Sulfasalazin (e.g. Azulfidine RA®, Pleon RA®), Hydroxychloroquine (e.g. Quensyl®); Azathioprin, Methotrexate (e.g. Lantarel®, Metex®), Etanercept (Enbrel®), Adalimumab (Humira®), Infliximab (Remicade®), Tocilizumab (RoActemra®), Golimumab (Simponi®), Certolizumab (Cimzia®), Abatacept (Orencia®)
16014467|NCT02779114|Other|Reduction group 1|Dose reduction of 50% for 12 months of previous treatment with Decortin H®, Leflunomid (e.g. Arava®), Ciclosporin (e.g. Immunosporin®), Sulfasalazin (e.g. Azulfidine RA®, Pleon RA®), Hydroxychloroquine (e.g. Quensyl®); Azathioprin, Methotrexate (e.g. Lantarel®, Metex®), Etanercept (Enbrel®), Adalimumab (Humira®), Infliximab (Remicade®), Tocilizumab (RoActemra®), Golimumab (Simponi®), Certolizumab (Cimzia®), Abatacept (Orencia®)
16014468|NCT02779114|Other|Reduction group 2|Dose reduction of 50% of previous treatment with Decortin H®, Leflunomid (e.g. Arava®), Ciclosporin (e.g. Immunosporin®), Sulfasalazin (e.g. Azulfidine RA®, Pleon RA®), Hydroxychloroquine (e.g. Quensyl®); Azathioprin, Methotrexate (e.g. Lantarel®, Metex®), Etanercept (Enbrel®), Adalimumab (Humira®), Infliximab (Remicade®), Tocilizumab (RoActemra®), Golimumab (Simponi®), Certolizumab (Cimzia®), Abatacept (Orencia®) for 6 months and if they are still in remission therapy will be discontinued.
16014469|NCT02779101|Drug|pembrolizumab|Pembrolizumab 200 mg every 3 weeks
16014470|NCT02779088|Other|exercise and nutrition|Exercise:muscle strengthening exercise Nutrition: 7.2 g branched chain amino acid every day and 1200 mg Ca+800 IU Vitamin D3
16014471|NCT02779075|Drug|Saline|Subjects will be studied on 2 occasions, in random order. During the saline study they will be infused with saline.
16014472|NCT02779075|Drug|Exendin-9,39|Subjects will be studied on 2 occasions, in random order. During the Exendin-9,39 study day they will be infused with Exendin-9,39. Exendin-9,39 blocks the actions of specific hormones called incretins, that are produced in the gut in health and in larger quantities after gastric bypass surgery.
16014473|NCT02779062|Other|Interview|Interview
16014474|NCT02779049|Other|Blood examination|blood sampling
16014475|NCT02779036|Procedure|Task-oriented home exercise|Structured, walking related task-oriented home exercise program with three progressive steps, at moderate to high intensity, 60 minutes per session, three sessions per week for total 8 weeks.
16014476|NCT02779036|Procedure|Usual Physiotherapy Care|Deficits-oriented free active and resisted lower extremity exercises with bicycling and overground walking , 60 minutes per session, three sessions per week for total 8 weeks.
16014477|NCT02779023|Behavioral|Cognitive-Behavior Therapy for Insomnia (CBT-I)|
16014478|NCT02779010|Behavioral|Hand washing with soap and Health education|Health education on key environmental variables and hand washing with soap
16014479|NCT02778997|Procedure|CSF Shunt treatment for hydrocephalus|State after CSF shunt implantation
16014480|NCT02778984|Device|QuadraLite masks|The intervention is identical in the two group
16014481|NCT02778984|Other|standard mask|
16014482|NCT02778971|Drug|[18F]Flutemetamol|amyloid PET imaging with [18F]Flutemetamol and subsequent modification of diagnosis and management
16014483|NCT02778958|Drug|paracetamol|"iv paracetamol flakon, 1 gram infusion at 30 min;
~iv morphine with patient controlled analgesia (1 mg demand bolus dose, 20 min lockout time)"
16014484|NCT02778958|Drug|ibuprofen|"iv ibuprofen flakon, 800 mg;
~iv morphine with patient controlled analgesia (1 mg demand bolus dose, 20 min lockout time)"
16014485|NCT02778945|Drug|Rocuronium 0.9 mg/kg|Neuromuscular block with Rocuronium 0.9 mg/kg for anesthetic induction Infusion of Rocuronium 0.3mg/kg/hr titrated to maintain a post-tetanic count (PTC)0-2 during the operation.
16014486|NCT02778945|Drug|Rocuronium 0.6 mg/kg|Neuromuscular block with Rocuronium 0.6 mg/kg for anesthetic induction Intermittent bolus i.v injection of Rocuronium 0.15mg/kg for train-of-four (TOF) 1-2 during the operation
16014487|NCT02778919|Drug|KLH-2109|
16014488|NCT02778919|Drug|Placebo|
16014489|NCT02778919|Drug|Leuprorelin acetate|
16014490|NCT02778906|Drug|Abatacept|Administration of Abatacept s.c. 125mg/weekly according to the Label for Rheumatoid arthritis
16014491|NCT02778906|Drug|Placebo|Administration of the comparator s.c. weekly in comparable to verum
16014492|NCT02778893|Drug|Conmana|125mg three times a day (TID) continuously
16014493|NCT02778893|Drug|Thalidomide|100mg one a day（QD）at night continuously,If can tolerance after 1 weeks to add to 200mg;
16014494|NCT02778880|Drug|Ketamine|
16014495|NCT02778880|Drug|Fentanyl|
16014496|NCT02778867|Other|1 Food Elimination Diet Therapy|
16014497|NCT02778867|Other|6 Food Elimination Diet Therapy|
16014498|NCT02778867|Other|6 Food Elimination Diet (after 1FED failure)|
16014499|NCT02778867|Drug|Fluticasone Propionate, 880 mcg twice daily (after 6FED failure)|
16014502|NCT02778828|Drug|Linezolid|adjustment of Linezolid of based on the AUC/MIC and % T> MIC for each patient to confirm the appropriateness, in light of the peak and residual, and the interest of the split doses more frequently performed in case of too low residual or toxicity.
16014503|NCT02778815|Other|Kindness for Mums|
16014504|NCT02778789|Drug|Tocilizumab|Patients will be treated with either i.v. Tocilizumab every 4 weeks or s.c. Tocilizumab weekly according to the label
16014505|NCT02778789|Drug|TNF-alpha Inhibitor|Patients will be treated with TNF-Inhibitors either i.v. or s.c. according to the label
16014506|NCT02778776|Drug|Metformin|Metfomin in tablet presentation of 500 mg
16014507|NCT02778776|Dietary Supplement|Agave inulin|Oligofructan in powder obtained from agave plant, it was given to each patient a full 10 mg container.
16014508|NCT02778776|Other|Placebo of agave inulin|Calcinated magnesia powder
16014509|NCT02778776|Other|Metformin placebo|Calcinated magnesia tablet
16014510|NCT02778763|Drug|CBLB612|4 μg CBLB612 SQ
16014511|NCT02778763|Drug|Placebo|
16014512|NCT02778750|Procedure|Two-Bronchoscope Technique|Used to validate the use of sputum to sample the lower airway microbiome
16014513|NCT02778737|Behavioral|ACT-based intervention|"Treatment sessions will be conducted weekly by two co-therapists in groups of approximately 8-10 participants for 1 ½ hours. Although each session has specific objectives, therapists within the time frame, are encouraged to accommodate participants' discussion or other group dynamic issues that may arise.
~Participants will receive their AP-ACT handbook including outlines of each session, activity plan assignments, and a CD with recorded mindfulness exercises.
~Session highlights and AP-ACT activities relevant to each session will be given at each meeting, so that participants will follow along with the treatment protocol. Individuals missing more than two consecutive sessions will be considered as dropouts."
16014514|NCT02778737|Behavioral|CBT-based intervention|"Treatment sessions will be conducted weekly by two co-therapists in groups of approximately 8-10 participants for 1 ½ hours. Although each session has specific objectives, therapists within the time frame, are encouraged to accommodate participants' discussion or other group dynamic issues that may arise.
~Participants will receive their AP-CBT handbook including outlines of each session, activity plan assignments, and a CD with recorded relaxation exercises.
~Session highlights and AP-CBT activities relevant to each session will be given at each meeting, so that participants will follow along with the treatment protocol. Individuals missing more than two consecutive sessions will be considered as dropouts."
16014515|NCT02778711|Drug|secukinumab|anti-IL-17
16014516|NCT02778698|Dietary Supplement|Omegaven|
16014517|NCT02778685|Other|Laboratory Biomarker Analysis|Correlative studies
16014518|NCT02778685|Drug|Letrozole|Given PO
16014519|NCT02778685|Drug|Palbociclib|Given PO
16014520|NCT02778685|Biological|Pembrolizumab|Given IV
16014521|NCT02778672|Other|Thermal imaging of infant's chest with a mobile phone|
16014522|NCT02778659|Drug|Zolpidem|The hypnotic will be administrated orally at 22:00 in the evening before a sleep recording and an early wake-up at 01:00 for cognitive and motor assessment.
16014523|NCT02778659|Drug|Placebo|The placebo will be administrated orally at 22:00 in the evening before a sleep recording and an early wake-up at 01:00 for cognitive and motor assessment.
16014524|NCT02778594|Drug|BIA 3-202|nebicapone 50 mg tablets; oral use
16014525|NCT02778594|Drug|Placebo|Nebicapone matching placebo tablets
16014526|NCT02778594|Drug|levodopa 100 mg / benserazide 25 mg|Madopar® HBS 125 (levodopa 100 mg / benserazide 25 mg) capsules; oral use
16014527|NCT02778581|Dietary Supplement|Lipidic Blend 1|daily intake of the content of one 45 mL bottle containing the product
16014528|NCT02778581|Dietary Supplement|Lipidic Blend 2|daily intake of the content of one 45 mL bottle containing the product
16014529|NCT02778581|Dietary Supplement|Placebo|daily intake of the content of one 45 mL bottle containing olive oil
16014530|NCT02778568|Behavioral|Resistance training|Resistance training exercises
16014531|NCT02778568|Behavioral|Control|Stretching exercises
16014532|NCT02778555|Behavioral|Questionnaires|
16014533|NCT02778542|Behavioral|Electronic Pill Bottle|Patients receive electronic pill bottle for their blood pressure medication. Study team can monitor pill bottle openings. Patients also receive daily text reminders to take their blood pressure medication.
16014534|NCT02778542|Behavioral|Bidirectional Text Messaging|Patients receive daily text reminders to take their blood pressure medication. Patients are asked to text their adherence daily.
16014535|NCT02778529|Device|Bilateral assessment robots (BiAS)|The BiAS are two passive desktop robots that will be used in this study to measure right and left arm kinematics for 4 different groups of patients.
16014536|NCT02778516|Dietary Supplement|Sodium Restriction|
16014537|NCT02778503|Other|High Cost|Surfaces allocated to this group will be treated with a high-cost glass ionomer cement restoration (Fuji IX, GC America, USA), according to the manufacturer's instructions.
16014538|NCT02778503|Other|Low Cost|Surfaces allocated to this group will be treated with a low-cost glass ionomer cement restoration (Maxxion R, FGM, BRA), according to the manufacturer's instructions.
16014539|NCT02778477|Drug|PF-06423264|Multiple ascending dose of PF-06423264
16014540|NCT02778477|Other|Placebo|Multiple dose of placebo
16014541|NCT02778451|Other|Measurement of competence|This study is a psychometric validation of a generic assessment tool to evaluate ultrasonography competence among surgeons
16014542|NCT02778425|Procedure|Endoscopic therapy+ beta blockers|Endoscopic variceal ligation (EVL) is for the secondary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).A standard dose of NSBB (propranolol) was applied to patients according to the Baveno VI recommendations if there were no contraindications.
16014543|NCT02778425|Procedure|Endoscopic therapy+ PSE+beta blockers|Endoscopic variceal ligation (EVL) is for the secondary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).A standard dose of NSBB (propranolol) was applied to patients according to the Baveno VI recommendations if there were no contraindications.Partial splenic embolization (PSE) is one of the intra-arterial therapeutic approaches to embolize 60-80% splenic blood flow.
16014544|NCT02778425|Procedure|beta blockers|A standard dose of NSBB (propranolol) was applied to the primary prevention patients according to the Baveno VI recommendations if there were no contraindications.
16086293|NCT02262637|Drug|MicardisPlus®|
16014545|NCT02778425|Procedure|Endoscopic therapy|Endoscopic variceal ligation (EVL) is for the primary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).
16014546|NCT02778425|Procedure|Endoscopic therapy+ PSE|Endoscopic variceal ligation (EVL) is for the primary prophylaxis of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).Partial splenic embolization (PSE) is one of the intra-arterial therapeutic approaches to embolize 60-80% splenic blood flow.
16014547|NCT02778425|Procedure|Somatostatin+Endoscopic therapy|The first dose of 250 was injected intravenously, followed by a continuous iv infusion of 250 for 3-5 days. Endoscopic variceal ligation (EVL) is for the acute bleeding of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).
16014548|NCT02778425|Procedure|Somatostatin+Endoscopic therapy+PSE|The first dose of 250 was injected intravenously, followed by a continuous iv infusion of 250 for 3-5 days. Endoscopic variceal ligation (EVL) is for the acute bleeding of esophageal variceal hemorrhage,and Cyanoacrylate injection is for gastric varices (GV).Partial splenic embolization (PSE) is one of the intra-arterial therapeutic approaches to embolize 60-80% splenic blood flow.
16014549|NCT02778399|Drug|Placebo|Placebo tablets for oral administration once daily
16014550|NCT02778399|Drug|OBE2109|OBE2109 tablets for oral administration once daily
16014551|NCT02778386|Drug|N-Methanocarbathymidine|Patients will receive 200 mg, 400 mg, 800 mg or 1200 mg of N-Methanocarbathymidine administered orally on day 1 after subject's full screen for each cohort. Each dose will be completely evaluated for safety and pharmacokinetics. The doses of each cohort will be given after complete evaluation of the preceding cohort for any sign of toxicity. In the absence of no observed toxicity, the next cohort will be started in the normal subjects.
16014552|NCT02778386|Other|Placebo Capsule|Two patients in Cohort 3 & 4 will receive placebo capsules which is mannitol filled into size 0 capsules.
16014553|NCT02778373|Dietary Supplement|Vitargo ®, Swecarb AB, Karlskrona, Sweden|
16014554|NCT02778373|Dietary Supplement|DE15 maltodextrin, Matrin® M160, Grain Processing Corporation, Muscatine, IA|
16014555|NCT02778373|Other|Placebo: Water|
16014556|NCT02778360|Device|Neurofeedback NFT|"The ADHD@Home Device is composed of a software for NF Training deployed on a Windows tablet, and connected to an EEG headset and an amplifier.
~The training is personalized according to patient's characteristics."
16014557|NCT02778360|Drug|Methylphenidate MPH|Drug prescribed with a first titration period until an optimal dose.
16014558|NCT02778334|Other|survey|"Patients who accept will be seen in maintenance during hospitalization in Neuro-Vascular Unit (UNV) (T0 = 4 to 7 days post-stroke)
~At the time of the release of the UNV two groups:
~patients who return home and
~patients who continued hospitalization in rehabilitation. Depression, anxiety, quality of life and coping strategies will be assessed by self-administered questionnaires. A first phase of ambulatory (ESM / EMA) will also take place following the (UNV) output: 5 times a day for 7 days patients will respond to questions evaluating depression, anxiety and coping strategies. Patients will answer these questions via a smartphone app (issues ESM).
~Another ambulatory phase on the same model as that performed at T1 (5 times daily for 7 days) accompanied by a self-assessment of depression, anxiety, coping strategies and quality of life will made 2 months post-stroke (T2).
~The last time the study will take place 4 months after stroke onset (T3)."
16014559|NCT02778321|Device|Uses of SpiderFlash monitor|"Investigators will use the SpiderFlash®, Holter monitor (technology Secure Data) to have a storage capacity enabling a registration up to 30 days with sufficient autonomy.
~The data collected :
~Demographic data: age, sex, vascular risk factors, antithrombotic therapy at the entrance, history of Transient Ischemic Accident (TIA) or Cerebral infarct (CI)
~Data on the CI:
~Monitoring Results scope ICU Neurovascular.
~Presence palpitations
~Treatment influencing the rate (beta-blockers or antiarrhythmic)
~Data on cardiac monitoring:
~A questionnaire evaluating the safety of SpiderFlash® will be given to the patient and the results of Holter will be communicated at the end of the recording to the blinded rhythm specialist"
16014560|NCT02778308|Drug|Gemcitabine + Cisplatin|Day 1 and day 8 Gemcitabine Day 1 cisplatin
16014561|NCT02778282|Other|MySafeRx™|The MySafeRx™ platform is a combination of several key components, including daily videoconferencing check-ins with motivational interviewing-based recovery coaching, text-messaging reminders, secure storage of buprenorphine medication within a secure electronic pill dispenser, and a standardized protocol for supervising self-administration of medication via videoconferencing.
16014562|NCT02778269|Device|12-lead ECG T-shirt|The 12-lead ECG T-shirt system consists of three parts: the recording device, amplifier boards and the T-shirt.The T-shirt has 10 textile ECG electrode patches. The patches should be in contact with the patient's skin to record the electrical activity of the heart. The electrodes are made of electrically conductive textile. They are sewn into the inside of the T-shirt and are padded with foam. The cables to the device can be attached to snap fasteners on the outer side of the T-shirt on the ECG electrode patches.
16014563|NCT02778269|Device|Dexcom G4-System|Continuous Glucose Monitoring
16014564|NCT02778256|Device|Vestibular stimulation|A specific vestibular stimulation technique is applied to the experimental group
16014565|NCT02778256|Device|Sham vestibular stimulation|Sham vestibular stimulation using lower than threshold stimuli. The absence of vestibular nystagmus confirms that it is sham.
16014566|NCT02778243|Biological|steroids concentrations determination|
16014567|NCT02778230|Dietary Supplement|Pea Fiber|Snacks (2 baked goods) fortified with 5 g pea hull fiber
16014568|NCT02778230|Dietary Supplement|Control|Snacks (2 baked goods) without fiber fortification.
16014569|NCT02778217|Procedure|Culture media renwal|
16014570|NCT02778204|Drug|Maraviroc|8 mg/kg oral solution as a single dose.
16014571|NCT02778204|Drug|Maraviroc|8 mg/kg oral solution given twice daily.
16014572|NCT02778191|Drug|cisplatin|100 mg/m2 day 1, 22 and 43
16014573|NCT02778191|Drug|carboplatin|carboplatin 300-350 mg/m2 day 1, 22 and 43
16014574|NCT02778191|Drug|5-FU|5-FU 600 mg/m2 days 1-4, 22-25 and 43-46
16014575|NCT02778178|Drug|ropivacaine plus clonidine|20 mL ropivacaine 3.75 mg/ml + 75 µg clonidine, per side
16014576|NCT02778178|Drug|Placebo|20 mL saline 0.9%, per side
16014577|NCT02778178|Device|ultrasound|
16014578|NCT02778165|Other|MyCaRe (my cardiac recovery Android application)|Application & Fitbit Flex activity monitor
16014579|NCT02778152|Device|Laser depilation|Laser depilation of natal cleft (pilonidal region)
16014580|NCT02778126|Drug|[¹⁴C]Prexasertib|Administered IV Infusion
16014581|NCT02778126|Drug|Prexasertib|Administered IV Infusion
16014582|NCT02778113|Drug|Nasal Glucagon|Administered intranasally.
16014583|NCT02778113|Drug|Glucagon|Administered SC.
16014584|NCT02778100|Drug|Nasal Glucagon|Administered intranasally.
16014585|NCT02778100|Drug|Oxymetazoline|Administered intranasally.
16014586|NCT02778087|Behavioral|Mirror Box Therapy|The BT intervention will be delivered in 15 minute increments via a self-directed program. The subject will sit comfortably at a table or desk in front of a box, which will be positioned in the mid-sagittal plane. The subject will place his or her affected arm inside the box so that it is out of view. The subject will then place his or her unaffected arm on the table and will be instructed to focus their attention on the mirror reflection of the unaffected arm throughout the intervention. The 15 minute intervention will consist of the following movements/tasks: active range of motion (AROM), functional tasks with objects, and object manipulation.
16014587|NCT02778087|Behavioral|Sham Mirror Box Therapy|The BT intervention will be delivered in 15 minute increments via a self-directed program. The subject will sit comfortably at a table or desk in front of a box, which will be positioned in the mid-sagittal plane. The subject will place his or her affected arm inside the box so that it is out of view. The subject will then place his or her unaffected arm on the table and will be instructed to focus their attention on an opaque mirror throughout the intervention. The 15 minute intervention will consist of the following movements/tasks: AROM, functional tasks with objects, and object manipulation.
16014588|NCT02778074|Behavioral|Internet cognitive behavioural therapy|A nine-week tailored I-CBT program for patients with CVD. The CBT program consists of the components of psychoeducation, relaxation, problem-solving and behavioural activation.
16014589|NCT02778074|Behavioral|Moderated Discussion Forum|Participants will be allocated to an internet moderated discussion forum during 9 weeks. Patients will discuss issues related to cardiovascular disease. A new topic will be discussed every week. After 9 weeks, those in the moderated discussion forum will be offered to perform the I-CBT program.
16014590|NCT02778048|Other|MRI (magnetic resonance imaging)|Assessment of the sphincter
16014591|NCT02778048|Other|US (ultra sound)|Assessment of the sphincter
16014592|NCT02778048|Other|FLIP (functional lumen imaging probe)|Assessment of the sphincter
16014593|NCT02778048|Other|HRAM (high resolution anal manometry)|Assessment of the sphincter
16014594|NCT02778035|Device|Dorsomedial prefrontal rTMS|Dorsomedial prefrontal rTMS, bilateral, iTBS, 600 pulses per hemisphere, 120% RMT, 2 sessions at 0, 30, or 60 min inter-session interval
16014595|NCT02778022|Behavioral|PriCARE|PriCARE is a group parent training program designed to improve child behavior, improve parent-child relationships, and decrease stress for parents. PriCARE utilizes the 3 P skills (Praise, Paraphrase and Point-out-Behavior) and includes a trauma and stress education component. The training starts with parenting skills focused on giving attention to children's positive, pro-social behaviors, while ignoring minor misbehaviors. The second phase of the training teaches techniques for giving children effective commands in order to set age-appropriate limits. We piloted PriCARE and demonstrated promising findings. The PriCARE intervention has been slightly modified from the pilot version to increase engagement and attendance.
16014596|NCT02778009|Radiation|iDEXA Scan|Subjects will receive pre study and post study scans to assess body mass composition
16014597|NCT02778009|Other|Wellness Lectures|Subjects in the Fit Physician Arm will be required to attend monthly wellness lectures
16014598|NCT02778009|Other|Exercise intervention|Subjects in the Fit Physician Arm will be required to attend weekly exercise interventions
16014599|NCT02778009|Other|Activity monitor|Subjects in the Fit physician arm and the activity monitor arm will receive activity monitors to assess their activity level throughout the academic year
16014600|NCT02777996|Device|Low Dose Computed Tomography|Assessment protocol were adopted from the ELCAP study (modified) for Non Calcific Nodule with a diameter of less- equal than 5 mm at baseline and 3mm at repeated.
16014601|NCT02777983|Behavioral|Educational Video App|The content of the app will be grounded in a biopsychosocial model and modeled on the Back Book, a booklet developed to help modify beliefs and behavior of patients with LBP. Essentially this will take the primary concepts and ideas often given in print or verbal form, and present it in a more engaging and dynamic fashion.
16014602|NCT02777970|Drug|Tramadol Hydrochloride/Dexketoprofen Trometamol|
16014603|NCT02777970|Drug|Tramadol Hydrochloride/Paracetamol|
16014604|NCT02777970|Drug|Placebo|
16014605|NCT02777944|Behavioral|Motivate: a web-based intervention|A web-based intervention focuses on managing expectations of assessment, addressing ambivalence and increasing users' motivation and confidence to attend their initial appointment. This is achieved through the use of information, motivational tools, interactive activities and stories from other individuals with EDs spread across four 15-20 minute modules.
16014606|NCT02777931|Drug|NFC-1|NFC-1 is supplied as size 2 hard gelatin capsules.
16014607|NCT02777931|Drug|Placebo|Matching placebo capsules
16014608|NCT02777918|Behavioral|Recipe provision|6 recipes will be provided every 2 weeks by post for 12 weeks
16014609|NCT02777905|Behavioral|Mindfulness Based Cognitive Therapy|
16014610|NCT02777892|Other|Sapien S3|Patients that have undergone percutaneous implantation of an Edwards SAPIEN S3 Transcatheter Heart Valve in the pulmonic position at the time of data collection
16014611|NCT02777879|Procedure|Bronchoscopy|Flexible bronchoscopy with bronchoalveolar lavage (BAL) and bronchial brushings will be done in a standardized manner. The bronchoscope tip is sequentially wedged in sub-segments where BAL will be performed on a total of two segments of the lung (120 ml in each segment for a total of 360 ml). Two brushes will be done under direct visualization in both segments. Selection of segments to sample will be based on where abnormalities are in imaging.
16014612|NCT02777866|Drug|Infiltration of 0.5% Bupivacaine|Patients who will be non urgent operated of an open gastrointestinal surgery, where an opening of the gastrointestinal lumen occurs (bile duct, stomach, small bowel or colon), who will be infiltrated in the total thickness of the abdominal wall (Peritoneum-muscle fascia- Subcutaneous tissue) with 0.5% Bupivacaine, every 1 cm, on each side of the surgical wound
16014655|NCT02777554|Drug|Apremilast IR|Apremilast immediate release tablet
16014656|NCT02777554|Drug|Apremilast XL|Apremilast extended release formulation tablet
16014929|NCT02775435|Drug|Saline placebo for pembrolizumab|IV infusion
16014613|NCT02777866|Drug|Placebo: Infiltration of 0.9% Saline Solution|Patients who will be non urgent operated of an open gastrointestinal surgery, where an opening of the gastrointestinal lumen occurs (bile duct, stomach, small bowel or colon), who will be infiltrated in the total thickness of the abdominal wall (Peritoneum-muscle fascia- Subcutaneous tissue) with 0.9% Saline Solution, every 1 cm, on each side of the surgical wound
16014614|NCT02777853|Dietary Supplement|Green tea|The intervention product is regular green tea brewed with hot water in a large quantity. The tea obtained is dried and the powder, with added sugar, is distributed over sealed aluminium sachets (1 gram of powder per sachet). The product has been cleared for consumption by Unilever's Microbiology Department and the independent Safety and Environmental Assurance Centre of Unilever.
16014615|NCT02777853|Dietary Supplement|Placebo tea|A product of similar colour and taste, but not the presumed actives of tea (polyphenols), is used as placebo. The product has been cleared for consumption by Unilever's Microbiology Department and the independent Safety and Environmental Assurance Centre of Unilever.
16014616|NCT02777840|Device|face mask oxygen|oxygen given by face mask as per routine practice
16014617|NCT02777840|Device|High flow oxygen|High flow oxygen given via optiflo machine / device
16014618|NCT02777827|Drug|Abediterol 0.156 μg|Dry powder for inhalation
16014619|NCT02777827|Drug|Abediterol 2.5 μg|Dry powder for inhalation
16014620|NCT02777827|Drug|Abediterol 0.05 μg|Pressurised metered-dose inhaler
16014621|NCT02777827|Drug|Abediterol 0.156 μg|Pressurised metered-dose inhaler
16014622|NCT02777827|Drug|Abediterol 2.5 μg|Pressurised metered-dose inhaler
16014623|NCT02777827|Other|Placebo|Pressurised metered-dose inhaler and dry powder for inhalation.
16014624|NCT02777814|Drug|Entecavir|anti hepatitis B virus
16014625|NCT02777801|Drug|Entecavir|anti-HBV
16014626|NCT02777788|Drug|JinFuKang|treated with chemotherapy
16014627|NCT02777788|Drug|XingZaoRuanJian|treated with chemotherapy
16014628|NCT02777788|Drug|pemetrexed,docetaxel,gemcitabine,paclitaxel or vinorelbine combined with carboplatin、cis-platinum or nedaplatin|
16014629|NCT02777775|Procedure|Skin Biopsy|"The procedure to sample the cutaneous neurofibroma involves a skin incision and will take approximately 10 to 15 minutes. The tissue will be taken in the following way:
~The skin area will be cleaned
~The skin area will be numbed (by either a numbing cream or a tiny numbing shot)
~Cutaneous (skin) Neurofibroma: will be taken via a small incision and removal of the neurofibroma whenever possible.
~A small piece of normal (skin) tissue will be numbed as above and taken using a special skin biopsy device.
~Afterward, the area will be cleaned and the skin put back together with medical super glue or 1 to 2 dissolvable stitches that will dissolve as the incision heals, they do not require removal. The purpose of taking this piece of skin is to compare normal skin with the skin of a cutaneous neurofibroma."
16014630|NCT02777762|Behavioral|Fun First|8 weekly interactive small-group sessions with a health coach
16014631|NCT02777762|Behavioral|Close at Hand|8 weekly check-ins with a state of the art, engaging mobile app
16014632|NCT02777749|Drug|Bupivacaine|15 cc's of 0.5% bupivacaine or 50 cc's of 0.25% short-acting bupivacaine (SB), intramuscular injection
16014633|NCT02777736|Drug|Methotrexate|i.v. or intrathecal CNS prophylaxis
16014634|NCT02777723|Drug|Xenobella|Hypotonic 0.3% Sodium Hyaluronate
16014635|NCT02777723|Drug|Isotonic 0.3% Sodium Hyaluronate|Isotonic 0.3% Sodium Hyaluronate
16014636|NCT02777710|Drug|Pexidartinib|Treatment will be administered as long as patient experience clinical benefit in the opinion of the investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent. If a DLT or a toxicity meeting the DLT definition but occurring outside of the DLT period, resolves to Grade ≤2 or the patient's baseline level within 14 days after toxicity onset, dosing may be resumed if agreed by the Sponsor at the same DL.
16014637|NCT02777710|Drug|Durvalumab|Treatment will be administered as long as patient experience clinical benefit in the opinion of the investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status or withdrawal of consent. If a DLT or a toxicity meeting the DLT definition but occurring outside of the DLT period, resolves to Grade ≤2 or the patient's baseline level within 14 days after toxicity onset, dosing may be resumed if agreed by the Sponsor at the same DL.
16014638|NCT02777697|Other|chronic pain|
16014639|NCT02777684|Other|Qualitative study|
16014640|NCT02777671|Drug|BIA 2-093|
16014641|NCT02777671|Drug|Gliclazide|tablets containing gliclazide 80 mg (Diamicron® 80 mg)
16014642|NCT02777645|Other|Growth, feeding evaluation|Z-scores of the nutritional indicators were calculated. The dietary assessment was performed by using the 24-hour recall method. The Behavioural Paediatrics Feeding Assessment Scale (BPFAS) was used to assess both frequencies of negative feeding behaviours and parents' problematic perceptions
16014643|NCT02777632|Procedure|Living donor liver transplantation|
16014644|NCT02777619|Drug|0.0ng/ml Dexmedetomidine|Dexmedetomidine target plasma concentration is 0.0ng/ml
16014645|NCT02777619|Drug|0.4ng/ml Dexmedetomidine|Dexmedetomidine target plasma concentration is 0.4ng/ml
16014646|NCT02777619|Drug|0.6ng/ml Dexmedetomidine|Dexmedetomidine target plasma concentration is 0.6ng/ml
16014647|NCT02777619|Drug|0.8ng/ml Dexmedetomidine|Dexmedetomidine target plasma concentration is 0.8ng/ml
16014648|NCT02777619|Drug|Propofol|
16014649|NCT02777606|Drug|Si-Ni-Tang|Treatment adheres to the International guidelines for management of severe sepsis and septic shock( 2012) and the Surviving Sepsis Campaign updated bundles in response to new evidence in 2015 for both the treatment group and the control group. In addition, 150ml of Si-Ni-Tang will be given by p.o. or by a nasogastric tube once a day for 3 days in the treatment group.
16014650|NCT02777593|Device|GORE® TAG® Thoracic Branch Endoprosthesis|Endovascular repair with the TBE Device
16014651|NCT02777580|Drug|Tenecteplase|Half dose Tenecteplase
16014652|NCT02777580|Drug|Clopidogrel|300 mg p.o. initial loading dose. Maintenance dose of 75 mg p.o. once daily. The maintenance dose of Clopidogrel (75 mg p.o. per day) should be continued for 1 year.
16014653|NCT02777580|Procedure|Coronary angiography|Coronary angiography followed by PCI or CABG if required, rescue PCI if required
16014654|NCT02777580|Procedure|Primary PCI|Primary PCI accoring to local standards
16014657|NCT02777541|Dietary Supplement|Resumption of feeding 3 hours after PEG placement|The first feeding will be with polymeric diet (1 kcal/ml). First feeding portion will have the volume equal to 1/3 of full recommended portion, volume of second feeding will be equal to 2/3 of full recommended portion and third portion will be equal to full recommended portion. Each portion will introduced thru the enteral feeding pump (Flocare Infinity, Nutricia), for 30 minutes, three-hour break between feeds. Infusion of 5% glucose solution with electrolytes will be given through intravenous line to cover maintenance fluid requirement in all subjects.
16014658|NCT02777541|Dietary Supplement|Resumption of feeding 8 hours after PEG placement|The first feeding will be with polymeric diet (1 kcal/ml). First feeding portion will have the volume equal to 1/3 of full recommended portion, volume of second feeding will be equal to 2/3 of full recommended portion and third portion will be equal to full recommended portion. Each portion will introduced thru the enteral feeding pump (Flocare Infinity, Nutricia), for 30 minutes, three-hour break between feeds. Infusion of 5% glucose solution with electrolytes will be given through intravenous line to cover maintenance fluid requirement in all subjects.
16014659|NCT02777528|Device|GORE® TAG® Thoracic Branch Endoprosthesis|Endovascular repair with the TBE Device
16014660|NCT02777528|Procedure|Revascularization Procedure|Revascularization procedure of the great vessel
16014661|NCT02777515|Behavioral|using electronic cigarette|"Assesment of patients, using electronic cigarette, presenting to the Rhythm of consultation for a cardiovascular evaluation by:
~A compendium of history, a general physical examination (weight, height) and cardiovascular with measurement of oxygen saturation, an assessment of past and current smoking (with documentation of the concentration of nicotine in the electronic cigarette and the product brand used)
~measurement of blood pressure
~An electrocardiogram
~A Holter-ECG 10 minutes
~A transthoracic echocardiogram"
16014662|NCT02777489|Drug|Perindopril|Perindopril Bluepharma 8 mg tablets, daily, during approximately 12 weeks
16014663|NCT02777476|Device|B-Lite- Light Weight Breast Implants|
16014664|NCT02777463|Other|diffusion-weighted MRI|Diffusion MRI Patients undergo MRI within 3 weeks before start of neoadjuvant therapy/ 5 weeks after the last dose. The setting of MRI scans for b-values is 0, 50, 1000 s/mm2. The same MRI (the MRI system/scanner Intera Achieva 3.0T from Philips Medical Systems) in the independent institution is used for all patients analyzed on this study. The region of interest is determined by consensus between two experienced MR radiologists in a largest diameter based on images of abdominal CT scans avoiding the vascular area on the image of ADC map. The mean ADC values for each tumor are automatically calculated on the image of ADC map using a tomographic software program.
16014665|NCT02777450|Procedure|lumbar facet block|injection of Levobupivacaine 0,25% and corticosteroids
16014666|NCT02777437|Drug|XELOX or FOLFOX chemotherapy|4 cycles of XELOX or FOLFOX neoadjuvant chemotherapy before surgery
16014667|NCT02777424|Drug|Prothrombin Complex Concentrate|Non-activated prothrombin complex concentrate containing factors II, VII, IX and X and proteins C & S
16014668|NCT02777424|Biological|Fresh Frozen Plasma|Pooled collection of plasma from donors
16014669|NCT02777411|Biological|EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AIPO4] per dose)|Two vaccinations at 28 days apart
16014670|NCT02777411|Biological|EV71 vaccine ([1 μg total protein + adjuvant 150 μg AIPO4] per dose)|Two vaccinations at 28 days apart
16014671|NCT02777411|Biological|EV71 vaccine ([2 μg total protein + adjuvant 150 μg AIPO4] per dose)|Two vaccinations at 28 days apart
16014672|NCT02777411|Biological|EV71 vaccine (2 μg total protein per dose)|Two vaccinations at 28 days apart
16014673|NCT02777411|Biological|EV71 vaccine ([0.5 μg total protein + adjuvant 150 μg AIPO4] per dose)|Two vaccinations at 28 days apart
16014674|NCT02777411|Biological|EV71 vaccine ([1 μg total protein + adjuvant 150 μg AIPO4] per dose)|Two vaccinations at 28 days apart
16014675|NCT02777411|Biological|EV71 vaccine (1 μg total protein per dose)|Two vaccinations at 28 days apart
16014676|NCT02777398|Procedure|Trans-Quadrant Channel Surgery|Patients in the experimental group will be general anaesthetized and placed in the prone position. Intra-operational electrophysiological monitoring will be used. Kirschner wire will be used to identify the position of the Quadrant channel with X-ray. After disinfection and draping, an incision of 3cm long and 2-3cm lateral to midline on the tumor side will be made. Soft tissues will be separated. Graded dilators will be used to establish Quadrant channel. Kerrison clamps will be used to expose the very local posterior spinal structures. Vertebral plate will be windowed with power drill to expose dural mater, and tumors will be removed with microsurgical techniques. Hemostasis will be performed after resection. Dural mater will be closed by titanium clips, and close incision by layers.
16014677|NCT02777398|Procedure|Conventional Open Surgery|Patients in the control group will be general anaesthetized during operation and placed in the prone position. Intra-operational electrophysiological monitoring will be used. Surgeons will locate the lesion by X-ray. After disinfection and draping, the midline incision of 7-10 cm and centered by the lesion segment will be made. Soft tissues will be cut and separated to expose posterior structure of spine. The root of spinal process and half of the vertebral plate on tumor side of certain segments will be removed. The dural mater will be opened. Then surgeons will remove tumor with microsurgical techniques. Hemostasis will be precisely performed after resection, and dural mater will be closed by suturing. Incision will be closed by layers. Drainage would be placed if necessary.
16014678|NCT02777385|Drug|Pembrolizumab|In both arms, the dose of pembrolizumab will be 200 mg (fixed dose) intravenous (IV) every 3 weeks for a total of 8 doses. In Arm 1, pembrolizumab will begin in week 10 of treatment, after cisplatin-IMRT is complete. In Arm 2, pembrolizumab will begin the week before cisplatin-IMRT.
16014679|NCT02777385|Drug|Cisplatin|Patients will receive cisplatin once weekly as an IV infusion over 60 minutes, for a total of 7 doses, at the same time as radiation.
16014680|NCT02777385|Radiation|IMRT|IMRT will be delivered in 35 fractions (treatments) over 7 weeks (five treatments per non-holiday week) in one plan.
16014681|NCT02777372|Drug|Sertraline|Sertraline will be provided at a dose of 50 mg daily for up to 3 weeks, depending on the length of a woman's luteal phase. Medication will be taken only during the luteal phase. Women will initiate sertraline treatment upon determining that they have ovulated (using a urine LH Kit) and remain on sertraline until onset of their next menstrual period at which time they will stop taking the medication.
16014716|NCT02777073|Drug|Placebo|Single dose of generic placebo
16014836|NCT02776163|Radiation|Intensity-modulated radiotherapy|a total dose of 60-66Gy in 30-32 fractions over 6-7 weeks
16014682|NCT02777359|Procedure|the transcatheter closure of PFO|the transcatheter closure of PFO was performed using the made-in-China occluders approved by SFDA,clopidogrel(50mg/d, 3mon) , aspirin (0.1g/d, 6mon), i.e. oral administration of aspirin (0.1g/d) and clopidogrel (50mg/d) at 48h before the closure; the low molecular weight heparin (LMWH) was routinely given at 48h after the closure; and some pain-relief drugs could be temporarily administered in the patients with acute onset of migraine.
16014683|NCT02777346|Device|Absorbable|"Wound suture by a resident physician. Two follow-up appointments (first at 4 to 21 days after the suture, according to the sutured site as defined by protocol, second at 6 months) Standardized photography of the wound before the suture and at the two subsequent follow-ups.
~Evaluation of the scar with a standardised form by a specialised nurse under medical supervision at the first follow-up and by a panel of investigators at 6 months using the pictures taken at the follow-up appointments."
16014684|NCT02777346|Device|Non absorbable|"Wound suture by a resident physician. Two follow-up appointments (first at 4 to 21 days after the suture, according to the sutured site as defined by protocol, second at 6 months) Standardized photography of the wound before the suture and at the two subsequent follow-ups.
~Evaluation of the scar with a standardised form by a specialised nurse under medical supervision at the first follow-up and by a panel of investigators at 6 months using the pictures taken at the follow-up appointments."
16014685|NCT02777333|Behavioral|Simulation training|Simulation training in a skills lab for 1 hour per week over 13 weeks on dry, bench-top box trainers and anatomical simulators
16014686|NCT02777320|Drug|paracetamol|1000 mg Paracetamol in 150 ml normal saline given as a slow intravenous infusion over 5 minutes (100 ml of saline is removed before the addition of the 100 ml paracetamol to be the same volume)
16014687|NCT02777320|Drug|Ibuprofen|400 mg Ibuprofen in 150 ml normal saline given as a slow intravenous infusion over 5 minutes
16014688|NCT02777307|Other|Hemopatch Sealing Hemostat|Place of Hemopatch Sealing Hemostat after laparoscopic cholecistectomy
16014689|NCT02777294|Behavioral|Online intervention|Therapist-facilitated, multimedia, cognitive-behavioral online intervention targeting rape-related PTSD
16014690|NCT02777294|Behavioral|Psycho-educational website|Psycho-educational self-help website about rape-related PTSD
16014691|NCT02777281|Behavioral|Shoulder pain and SCI|Shoulder pain and SCI
16014692|NCT02777281|Behavioral|Shoulder pain and able bodies|
16014693|NCT02777268|Drug|Infacort|Multi-particulate granules
16014694|NCT02777268|Drug|Hydrocortisone|Tablet
16014695|NCT02777242|Combination Product|Testosterone enanthate auto-injector|SC injections of QST 50 mg or 75 mg or 100 mg
16014696|NCT02777229|Drug|Dolutegravir 50 mg|1 tablet once a day
16014697|NCT02777229|Drug|Tenofovir disoproxil fumarate 300 mg / lamivudine 300 mg|Fixed dose combination, 1 tablet once a day
16014698|NCT02777229|Drug|Efavirenz 400 mg|1 tablets once a day
16014699|NCT02777216|Device|ConfidenHT system|ConfidenHT Medical system
16014700|NCT02777203|Device|EcoSac 400 ECO-T|Laparoscopy will be performed in the standard multi-port technique. The specimen will be morcellated in the EcoSac400 ECO-T bag.
16014701|NCT02777190|Drug|Misoprostol|Comparing dosing of misoprostol 25 mcg orally every 2 hours versus 25 mcg vaginally every 4 hours.
16014702|NCT02777164|Device|MIRA device imaging|MIRA Device imaging for adjunctive detection of breast cancer
16014703|NCT02777151|Drug|REGN3470-3471-3479|
16014704|NCT02777151|Drug|Placebo|
16014705|NCT02777138|Other|Maintaining a normal daily living lifestyle|participants will undertake a normal lifestyle with no alterations to daily living in order to access the differences in tissue (muscle and adipose) and systemic inflammation between the two age cohorts
16014706|NCT02777125|Device|Metered Dose Inhaler|A metered dose inhaler (MDI) is a small hand held pressurized canister device that contains both a medication, in this case albuterol, and a propellant. Pressing the device delivers 90mcg of albuterol. The MDI is attached to a spacer device, which is a one way holding chamber which allows the medication to be delivered over a series of breaths.
16014707|NCT02777125|Device|Breath Actuated Nebulizer|The breath actuated nebulizer (BAN) device is a device that converts liquid medication, in this case albuterol, into an aerosol. It consists of a mouthpiece, a medication reservoir, and connective tubing that attaches to a compressor. This BAN device delivers medication when the patient takes a breath, but it can be attached to a mask and set to continuous nebulization for patients that are not able to coordinate their breaths.
16014708|NCT02777112|Other|e-mental health program|This program is delivered over the Internet, which includes modules of Information (about depression, workplace factors and alcohol use), Practical Tips (Cognitive Behavioral Therapy, Mindfulness relaxation, workplace strategies), Tools (for monitoring and predicting depression and occupational functioning), and Goal Setting and Tracking.
16014709|NCT02777112|Other|e-mental health program and job coaching|This combines the e-mental health program and interactive job coaching delivered through telephone. The e-mental health program is delivered over the Internet, which includes modules of Information (about depression, workplace factors and alcohol use), Practical Tips (Cognitive Behavioral Therapy, Mindfulness relaxation, workplace strategies), Tools (for monitoring and predicting depression and occupational functioning), and Goal Setting and Tracking. The job coaching can be accessed by appointment.
16014710|NCT02777112|Other|No intervention|Receiving generic information about men's depression from the Movember Foundation website: https://ca.movember.com/programs/mental-health
16014711|NCT02777099|Procedure|remote ischemic postconditioning|Remote ischemic postconditioning was performed by 4 cycles of upper-limb ischemia and reperfusion.The upper-limb ischemia was induced by inflating a blood pressure cuff on a healthy upper arm to 200 mmHg for 5 min,and then deflating it for 5 min.Each patients in the PIPostC group will have the treatment once a day for 30 days.
16014712|NCT02777099|Procedure|sham remote ischemic postconditioning|Sham remote ischemic postconditioning was performed by 4 cycles of upper-limb ischemia and reperfusion. The upper-limb ischemia was induced by inflating a blood pressure cuff on a healthy upper arm to the patient's actual diastolic blood pressure for 5 min,and then deflating it for 5 min.Each patients in the sham PIPostC group will have the sham treatment once a day for 30 days.
16014713|NCT02777086|Behavioral|StaySafe|StaySafe is a self-administered tablet computer app designed to improve decision-making around health risk behaviors.
16014714|NCT02777073|Drug|Farxiga|Single dose of dapagliflozin
16014715|NCT02777073|Drug|Victoza|Single dose of Liraglutide
16014717|NCT02777060|Procedure|Exergame|Subjects will perform progressive and computerized foot and ankle exercises which include weight shifting, ankle reaching task while standing, and virtual obstacle crossing task (i.e. balancing on single leg) using wearable sensors technology (Exergaming) equipment). Subjects will perform these exercises for 4-6 weeks, twice per week. The duration of exercise per session is anticipated to be 30-45 minutes.
16014718|NCT02777060|Procedure|Home based balance training|Subjects in the control group will ask to perform a standard home based balance program for 4-6 weeks. The home based program includes similar exercise components as proposed in the experimental group, however without computerized feedback and Exergaming equipment.
16014719|NCT02777047|Other|Anticoagulation Coordinated Care|see above
16014720|NCT02777034|Other|ER|"Preoperative protocols：Multidisciplinary patient information、no bowel preparation、no fasting（drink 10% glucose 1000 at 21：30 night before the surgery）.
~Intraoperative protocols：Laparoscopic standardized technique、fluid restriction (max 500 ml/h)、no abdominal drains.
~Postoperative protocols：no nasogastric tube、early solid dietary intake and mobilization、urinary catheter removal on postoperative day 1、restrictive fluid management（<2000ml/d）."
16014721|NCT02777034|Other|UR|"Preoperative protocols：Patient information、Mechanical bowel preparation、Fasting since midnight before operation.
~Intraoperative protocols：Laparoscopic standardized technique、fluid overload (over 500 ml/h) 、place abdominal drains.
~Postoperative protocols：no nasogastric tube、mobilization from postoperative day 1、fluids and solids intake after first passage of stool、Urinary catheter removal on postoperative day 2/3、no restrictive fluid management（>2000ml/d）."
16014722|NCT02777008|Drug|CTP-543|
16014723|NCT02777008|Drug|Placebo for CTP-543|
16014724|NCT02776995|Other|Thermography imaging|Thermography imaging of the treated - irradiated body area.
16014725|NCT02776982|Procedure|Confocal endomicroscopy|Confocal endomicroscopy will be performed during clinically indicated endoscopy.
16014726|NCT02776982|Procedure|Mucosal impedance|Mucosal impedance will be performed at the time of clinically indicated endoscopy.
16014727|NCT02776982|Procedure|Research biopsies|Research biopsies will be obtained during clinically indicated endoscopy.
16014728|NCT02776982|Procedure|Bravo ambulatory pH monitor|Bravo ambulatory pH capsule will be placed during clinically indicated endoscopy.
16014729|NCT02776956|Drug|atorvastatin group|Patients in atorvastatin group will orally receive 20 mg of atorvastatin per night (Pfizer) for three days before the operation and three months after the operation
16014730|NCT02776956|Drug|non-atorvastatin group|Patients in non-atorvastatin group will not receive atorvastatin before the operation and after the operation.
16014731|NCT02776943|Biological|umbilical cord mesenchymal stem cells|
16014732|NCT02776943|Device|Hyaluronic acid|
16014733|NCT02776917|Drug|Cirmtuzumab + Paclitaxel|Cirmtuzumab and paclitaxel may be administered until disease progression or unacceptable toxicity. Cirmtuzumab or paclitaxel may be continued alone if the other drug is discontinued due to toxicity.
16014734|NCT02776904|Other|Immediate Post-concussion Assessment and Cognitive Testing|Computerized assessment that provides information related to visual reaction time and visual memory.
16014735|NCT02776904|Other|Gait with single and dual task|Walking alone and then walking while performing a memory task on a tablet.
16014736|NCT02776904|Other|Y-Balance test|Dynamic balance test measuring reaching of the leg to the anterior,postero- lateral, and postero-medial directions.
16014737|NCT02776904|Other|Psychomotor Vigilance Task|Assessment measuring reaction time based on auditory cues.
16014738|NCT02776891|Drug|Gallium citrate|Ga-68 citrate will be administered on an outpatient basis at the Center for Molecular and Functional Imaging at China Basin. It will be administered a single time point intravenously prior to PET imaging. The one-time nominal injected dose will be up to 15 mCi containing 10 - 25 μg Ga-68. A simultaneous MRI (PET/MRI) of the head will be used for attenuation correction and anatomic localization of gallium-68 citrate uptake and standardized uptake value (SUV) calculation.
16014739|NCT02776878|Drug|dasatinib|
16014740|NCT02776865|Drug|suprascapular nerve block|4ml 2% xylocaine
16014741|NCT02776865|Other|physical therapy|patient received traditional physical therapy, including therapeutic exercise and stretch exercise
16014742|NCT02776852|Drug|Coppertone (BAY987517)|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Number: SR15-43-Y65-158)
16014743|NCT02776839|Device|Mobile sensing|
16014744|NCT02776813|Biological|ACTR087|
16014745|NCT02776813|Biological|rituximab|
16014746|NCT02776800|Device|Allevyn Life|
16014747|NCT02776800|Device|Foam dressing with an integrated adhesive border|Foam dressing normally used by the home health agency
16014748|NCT02776761|Biological|Hantaan Vaccine:|DNA Vaccine 2.0 mg/1 mL phosphate-buffered saline
16014749|NCT02776761|Biological|Puumala Vaccine|DNA Vaccine 2.0 mg/1 mL phosphate-buffered saline
16014750|NCT02776761|Biological|Hantaan/Puumala Vaccine|DNA Vaccine 2.0 mg/1 mL phosphate-buffered saline
16014751|NCT02776748|Drug|FTC/TDF PrEP|Daily oral directly observed FTC/TDF PrEP administered to breastfeeding HIV-uninfected women
16014752|NCT02776735|Drug|Sarilumab|Pharmaceutical form:Solution Route of administration: Subcutaneous
16014753|NCT02776722|Other|fructose, allulose, tagatose, or sorbose|Single-bolus feeding of fructose, allulose, tagatose, or sorbose given together with a reference carbohydrate(s) compared with the same reference carbohydrate(s) alone for acute feeding trials or chronic feeding of fructose, allulose, tagatose, or sorbose provided in substitution for other reference carbohydrates or added to a control diet compared with the reference carbohydrate(s) alone or the control diet alone for chronic feeding trials.
16014754|NCT02776709|Procedure|ERCP with cholangioscopy|
16014755|NCT02776696|Device|Advanced Hybrid Closed Loop System|
16014756|NCT02776696|Device|Hybrid Closed Loop System|
16014757|NCT02776683|Drug|BI 695502|
16014758|NCT02776683|Drug|Avastin|
16014759|NCT02776670|Other|Propylene glycol, 0.6% eye drops|
16014760|NCT02776670|Other|Lubricant eye drops|
16014761|NCT02776657|Other|Magnetic Resonance Imaging|Each participant will undergo at least one MRI scan. A small number will be asked to undergo repeat MRI scanning at one and three months following the initial scan.
16014837|NCT02776137|Drug|Docetaxel|Docetaxel: 20mg/m2/w for 6 weeks
16014762|NCT02776657|Device|Optical Coherence Tomography|Participants may undergo Optical Coherence Tomography (OCT) during the angiogram procedure in order to detect thrombus within the coronary arteries.
16014763|NCT02776657|Procedure|Invasive Coronary Angiography|This will be performed as part of usual care and does not constitute part of the research project.
16014764|NCT02776631|Device|Pinloc|Internal fixation device
16014765|NCT02776631|Device|Hansson Pins (LIH)|Internal fixation device
16014766|NCT02776618|Procedure|running subcuticular closure of excisional defect|Excisional defects will be repaired with deep polyglactin 910 sutures, followed by each half of the wound given randomly assigned subcuticular superficial closure as described in the treatment arms.
16014767|NCT02776605|Drug|Prednisone|Prednisone 60 mg/m2/day IV over 7 days (-7 a -1) and triple intrathecal therapy (TIT)
16014768|NCT02776605|Drug|Vincristine|Vincristine (VCR): 1.5 mg/m2 (maximum 2 mg) IV days 1, 8, 15 and 22.
16014769|NCT02776605|Drug|Daunorubicin|Daunorubicin (DNR): 45 mg/m2 IV days 1, 8, 15 and 22.
16014770|NCT02776605|Drug|Prednisone|Prednisone (PDN): 60 mg/m2/day, IV or PO, days 1 to 27.
16014771|NCT02776605|Drug|Ponatinib|Ponatinib 30 mg, PO from day 1 to consolidation
16014772|NCT02776605|Drug|Mercaptopurine|Mercaptopurine (MP): 50 mg/m2, PO days 1 to 7, 28 to 35 and 56 to 63.
16014773|NCT02776605|Drug|Methotrexate|MTX: 1,5 g/m2, IV (24 h continuous infusion) days 1, 28 and 56
16014774|NCT02776605|Drug|VP-16|VP-16: 100 mg/m2/12 h, IV, days 14 and 42
16014775|NCT02776605|Drug|ARA-C:|ARA-C: 1000 mg/m2/12 h, IV, days 14-15 and 42-43.
16014776|NCT02776605|Drug|TIT|TIT (MTX: 12 mg, ARA-C: 30 mg, hydrocortisone: 20 mg), , days 1, 28 and 56.
16014777|NCT02776605|Drug|Ponatinib|Ponatinib 30 mg/d PO, from day 1 to 15 days before HSCT.
16014778|NCT02776605|Procedure|Autologous transplantation|Myeloablative conditioning with cyclophosphamide and total body irradiation (TBI) whenever possible and autologous transplantation
16014779|NCT02776605|Procedure|Allo transplantation|Myeloablative conditioning with cyclophosphamide and total body irradiation (TBI) whenever possible and allo transplantation
16014780|NCT02776592|Other|Cow's milk-based formula with added nutrients|
16014781|NCT02776592|Other|Cow's milk-based formula|
16014782|NCT02776579|Other|Girls-only resistance training|
16014783|NCT02776566|Other|Patient Self-Monitoring vs Anticoagulation Clinic|"Patient Self-Monitoring (intervention): entails 3 education sessions of 90-120 minutes each (week 0, week 2, week 4): 2 provided on site in clinic and 1 in the patient's home, during which, self-testing competency and barriers and facilitators to self-monitoring will be evaluated. Subjects will follow with weekly (or sooner, if clinically indicated) in-home self-monitoring and follow-up weekly phone calls over 6 months by clinical pharmacists to guide warfarin dosing and reinforce key educational messages.
~Anticoagulation Clinic (control): subjects will have their INR tested in clinic monthly (or more frequently if clinically indicated) via the Coaguchek® point-of-care device (which is the standard of care in the Anticoagulation Clinic) and receive dosing instructions and standardized education related to warfarin by a clinical pharmacist who provides care in the Anticoagulation Clinic."
16014784|NCT02776553|Other|Nutritional consultation|Dietary advice will be provided at the beginning of the study and individually tailored to the participant's usual eating habits plus amino acid supplement including 10 grams of branched-chain amino acids
16014785|NCT02776553|Behavioral|Physical training program|Physical activity prescription will target ≥10,000 steps/day, taking into account all activities performed throughout the day, although the increment in activity should be no less than 3000 steps/day above the baseline.
16014786|NCT02776553|Behavioral|Behavioral modification therapy|The behavior modification theory will be applied in the form of a structured set of cues and questions between investigator and participant at each visit in order to provide individually tailored counseling to enhance internal motivation and facilitate behavior change toward physical activity and dietary improvement that are adaptable to each participant's usual habits.
16014787|NCT02776540|Drug|Clopidogrel|there is 2 groups one group will receive 900 mg Clopidogrel and the other will receive 600 mg Clopidogrel
16014788|NCT02776540|Drug|Aspirin|there's another group will receive 400 mg Aspirin
16014789|NCT02776527|Drug|Apatinib Mesylate Tablets|taking Apatinib Mesylate Tablets 500mg/qd orally, 28 days as a cycle, till disease progresses
16014790|NCT02776514|Drug|Triamcort|Fluoroscopic guided injection in the knee joint
16014791|NCT02776514|Drug|Platelet-rich-plasma|
16014792|NCT02776514|Drug|Suplasyn1|
16014793|NCT02776514|Drug|Placebo|
16014794|NCT02776501|Drug|Coppertone (BAY987521)|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation: Y49-103)
16014795|NCT02776488|Drug|Lactate|Infusion of exogenous lactate
16014796|NCT02776475|Procedure|Sacral neuromodulation device turned off|Each patient will be to have the sacral neuromodulation device turned off for four consecutive weeks.
16014797|NCT02776462|Device|EyeBox CNS|
16014798|NCT02776436|Drug|Dexamethasone|Dose of prophylactic dexamethasone will be reduced for all patients
16014799|NCT02776436|Drug|Prednisone|standard prednisone 5 mg bid for patients with prostate cancer
16014800|NCT02776423|Procedure|Bulkamid|The procedure was standardized, identical for all patients, and entirely performed in an outpatient setting. All injections were performed by a single urogynecologist. Before injection all patients received a single dose trimethoprim (Idotrim®, Orion Pharma). The patient was placed in a supine position and given intraurethral topical 2% lidocaine hydrochloride gel (Xylocain®, Astra Zeneca) for anesthetic. Using a video-urethroscope and a 23-gauge needle, polyacrylamide hydrogel deposits of 0.3-0.4 mL were injected at 12, 4 and 8 o´clock into the submucosa approximately 1 cm from the bladder neck. Patients were discharged after successful voiding.
16014801|NCT02776410|Behavioral|Consumer reactions to tailored messages sent via app|The intervention will take 1 month. Participants from the Intervention group will receive tailored messages every 2-3 days with a push notification. Additionally, interaction with the participants via the use of app is foreseen.
16014832|NCT02776176|Procedure|Enhanced Recovery After Surgery Program|optimized peri-operative protocol
16014833|NCT02776176|Procedure|Traditional Program|traditional standard protocol
16014834|NCT02776163|Drug|Cisplatin|Cisplatin 80mg/m^2，D1-3，2 cycles
16014835|NCT02776163|Drug|Docetaxel|Docetaxel 70mg/m^2，D1，2 cycles
16014802|NCT02776397|Dietary Supplement|Vitamin E|Two hundred patients will be recruited to a pilot randomized controlled trial (RCT), stratified by Hp 2-2 phenotype status (100 Hp 2-2 and 100 non-Hp 2-2), and randomly allocated in a 1:1 ratio to either vitamin E 400 IU supplementation daily for 6 months or a placebo group. The trial will determine whether vitamin E improves the aforementioned surrogate markers in the Hp phenotype strata.
16014803|NCT02776397|Other|Placebo|Placebo arm
16014804|NCT02776384|Other|Observational study|
16014805|NCT02776371|Drug|Modified non-clarithromycin triple therapy|H. pylori infected patients treated with 10 mg rabeprazole twice a day, and 1g amoxicillin, 500 mg tinidazole three times a day for 14 days.
16014806|NCT02776371|Drug|Sequential therapy|H. pylori infected patients treated with 10 mg rabeprazole and 1 g amoxicillin, twice daily for 7 days, followed by 10 mg rabeprazole, 500 mg clarithromycin, and 500 mg tinidazole, twice daily for the next 7 days.
16014807|NCT02776358|Other|High Fidelity Simulation|"A HFS session for an asthma attack require:
~a 5 minutes briefing session: case and equipments presentation and choice of participants
~15 minutes of actual simulation
~40 minutes of debriefing
~A pre and a post test will be taken by the students before and after the session and a satisfaction questionnaire at the end of the course.
~Also, another test will be done after 7 days of the course."
16014808|NCT02776358|Other|Video case|"a video case (or video box) session in which students will attend a video-projection of a real case of an asthma attack and discuss with the trainer the different steps of the assessement and management of an asthma attack.
~A pre and a post test will be taken by the students before and after the session and a satisfaction questionnaire at the end of the course.
~Also, another test will be done after 7 days of the course."
16014809|NCT02776345|Other|Ultrasound guided Needle Fragmentation|Using 15-20 to and fro gentle movements of the needle tip, the calcification will be fragmented, with the needle tip within the pseudocapsule. The needle tip will be retracted into the subacromial bursa and 3 ml of 0.5% sensorcaine and 1 ml of steroid ( Depomedrol- 40mg/ml) will be injected into the bursa. The needle will then be removed.
16014810|NCT02776345|Other|US guided needle fragmentation & Lavage|Using local anesthetic and strict aseptic precautions, the tip of the 18-20 gauge needle will be advanced into the sub acromial bursa under ultrasound guidance and 2ml. of local anesthetic ( 1% xylocaine) will be injected into the bursa. The needle tip will be advanced into the supraspinatus tendon and ½ ml or less of 0.5% Sensorcaine will be injected into the pseudo capsule around the calcification. Using 15-20 to and fro gentle movements of the needle tip, the calcification will be fragmented, with the needle tip within the pseudo capsule. During this procedure, or after the fragmentation, using a syringe of saline or local anesthetic( 1% xylocaine) and with pumping action of the syringe the calcification with be sucked into the syringe.
16014811|NCT02776345|Other|Ultrasound guided subacromial injection|Using local anesthetic and strict aseptic precautions, the tip of the 22 gauge needle will be advanced into the sub acromial bursa under ultrasound guidance and 4 ml. of local anesthetic ( 0.5% xylocaine) and 1 ml of steroid( Depomedrol 40 mg/ml) will be injected into the bursa. The needle will then be removed. Post procedure US images in the short and long axis planes will be obtained and documented. The patient's post procedure pain on a scale of 10 and their range of shoulder movement (abduction) will be assessed and documented.
16014812|NCT02776332|Procedure|Manual Expression of Breastmilk|Breastfeeding log for 14 days after delivery Video of manual expression for teaching and reinforcement Complete breastfeeding self-efficacy scale at 1 day and 14 days after delivery
16014813|NCT02776319|Device|Non-invasive brain stimulation (active)|Non-invasive brain stimulation (active)
16014814|NCT02776319|Device|Non-invasive brain stimulation (sham)|Non-invasive brain stimulation (sham)
16014815|NCT02776306|Other|Mirror Box therapy|In mirror box therapy the patient uses the reflection of their good arm to trick to brain into thinking that the effected arm is working.
16014816|NCT02776293|Behavioral|Relaxation|
16014817|NCT02776293|Behavioral|Music|
16014818|NCT02776280|Other|Meal|Typical Brazilian meal consisting of rice, beans and meat with vegetables
16014819|NCT02776267|Device|Angiolite stent|Following index PCI, patients will be followed via scheduled clinic and/or phone contact at 1-, 3-, 6-, 12- and 24-month. Patient will be randomized to undergo a scheduled repeat coronary angiogram and OCT evaluation at either at 3- or 6-month post index PCI.
16014820|NCT02776254|Other|START|Point of care testing for rapid ART initiation
16014821|NCT02776254|Other|CAG|Community Adherence Group
16014822|NCT02776254|Other|UAG|Urban Adherence Group
16014823|NCT02776254|Other|FAST-TRACK|Prescription refill only
16014824|NCT02776241|Other|water|
16014825|NCT02776228|Drug|Brotizolam|Every patient which will enroll to the study will fill up The Pittsburgh Sleep Quality Index in there admission to the cardiac surgery unit. in the discharge day the patient will receive 0.25 mg brotizolam once a day before sleep for six weeks. one week and six weeks after discharge day, there is routine follow up in our outpatient clinic. in those appointed time the patient will fill again The Pittsburgh Sleep Quality Index.
16014826|NCT02776228|Drug|placebo|Every patient which will enroll to the study will fill up The Pittsburgh Sleep Quality Index in there admission to the cardiac surgery unit. in the discharge day the patient will receive 0.25 mg LACTOSE once a day before sleep for six weeks. one week and six weeks after discharge day, there is routine follow up in our outpatient clinic. in those appointed time the patient will fill again The Pittsburgh Sleep Quality Index.
16014827|NCT02776215|Drug|tasimelteon|Melatonin receptor agonist
16014828|NCT02776202|Drug|Fludarabine monophosphate|"The HSCT preparative regimen will consist of
~Thymoglobulin: 2.5 mg /kg/day intravenously (IV) on Days -8 through -5
~Fludarabine: 35 mg/m2/day IV on Days -8 through -4
~Melphalan: 140 mg/m2 IV on Day -3
~Rest on Day -2 and -1
~Day 0 is the day of transplant
~GVHD prophylaxis: sirolimus beginning on Day -1 for at least one year and mycophenolate mofetil (MMF) from Day -3 to +45 or to 7 days after neutrophil engraftment, whichever is later."
16014829|NCT02776189|Drug|Dexmedetomidine|intravenous dexmedetomidine 1 mcg per kg body weight over 10 minutes followed by infusion of dexmedetomidine at dose of 1 mcg per kg body weight per hour till end of procedure
16014830|NCT02776189|Drug|propofol|intravenous propofol 2mg per kg body weight followed by infusion of propofol at a dose of 100 mcg per kg body weight per min till end of procedure
16014831|NCT02776189|Drug|Midazolam|Intra nasal midazolam 0.2 mg per kg body weight before intravenous canulation
16015588|NCT02770664|Drug|LC28-0126 Dose A|LC28-0126 Dose A
16014838|NCT02776137|Radiation|Intensity-modulated radiotherapy|a total dose of 60Gy in 30 fractions over 6 weeks
16014839|NCT02776124|Dietary Supplement|Healing Elements,Methuselah Medical Technology|ONS group will receive Healing Elements ONS everyday during CRT
16014840|NCT02776111|Other|Blood Sample|A one time blood sample will be provided.
16014841|NCT02776059|Drug|Standard of care + pegfiltrastim|prednisolone or pentoxifyline orally for 28 days + pegfilgrastim (Neulasta®) 6 mg in 0.6 mL SQ
16014842|NCT02776059|Drug|Standard of care|Oral prednisolone or pentoxifyline for 28 days only
16014843|NCT02776046|Drug|High FiO2|High FiO2 with a perioperative open lung strategy
16014844|NCT02776046|Drug|Conventional FiO2|Conventional FiO2 with a perioperative open lung strategy
16014845|NCT02776033|Drug|GSK2982772|GSK2982772 will be supplied as a white to almost white, round, film coated 30 mg oral tablets; two tablets to be taken in the morning and two in the evening, as directed for Cohort 1 and for Cohort 2 two tablets to be taken three times daily as directed.
16014846|NCT02776033|Drug|Placebo|Matching placebo will be supplied as a white to almost white, round film coated tablets; two tablets to be taken in the morning and two in the evening, as directed for Cohort 1 and for Cohort 2 two tablets to be taken three times daily as directed.
16014847|NCT02776020|Device|CorrecDose Infrared Monitor|The monitor is attached to patient's wrist and ear in order to measure changes in propofol concentrations in blood
16014848|NCT02776007|Device|Libre Flash CGMS|
16014849|NCT02776007|Device|Self-Measurement Blood Glucose|Patients will use their personal glucose meter to perform Self-Measurement Blood Glucose
16014850|NCT02775994|Drug|Canakinumab|interleukin beta (IL-1) antagonist
16014851|NCT02775981|Drug|RX0041-002|
16014852|NCT02775968|Drug|Cephalosporins and Macrolide Antibiotics|The intervention drugs are prescribed by treating caregiver.
16014853|NCT02775955|Drug|RX0041|Active
16014854|NCT02775942|Biological|IMOVAC-POLIO|IMOVAC-POLIO (Sanofi Pasteur), liquid form composition: Type 1 (Mahoney) 40DU, Type 2 (MEF1) 8DU, Type 3 (Saukett) 32 DU, Subcutaneous route 0.5ml/dose, 3 doses, 4-week interval
16014855|NCT02775942|Biological|IPOVAC 1.5:5:5|IPOVAC- POLYVAC Vietnam Composition: Type 1: 1.5DU, Type 2: 5DU, Type 3:5DU Subcutaneous inj 0.5ml/dose, 3 doses, interval 30days +/- 3 days Liquid form
16014856|NCT02775942|Biological|IPOVAC, 3:10:10|IPOVAC- POLYVAC Vietnam Composition: Type 1: 3DU, Type 2: 10DU, Type 3:10DU Subcutaneous inj 0.5ml/dose, 3 doses, interval 30days +/- 3 days Liquid form
16014857|NCT02775942|Biological|IPOVAC, 6:20:20|IPOVAC- POLYVAC Vietnam Composition: Type 1: 6DU, Type 2: 20DU, Type 3:20DU Subcutaneous inj 0.5ml/dose, 3 doses, interval 30days +/- 3 days Liquid form
16014858|NCT02775929|Drug|FTC-TDF PrEP|FTC-TDF PrEP for HIV-1 uninfected partners
16014859|NCT02775929|Drug|ART|ART for HIV-1 infected partners
16014860|NCT02775916|Drug|CDZ173|
16014861|NCT02775916|Drug|Placebo|
16014862|NCT02775903|Drug|Azacitidine|Administered by subcutaneous injection on Days 1 to 7 of each 4-week treatment cycle.
16014863|NCT02775903|Biological|Durvalumab|Administered by intravenous infusion on Day 1 of every 4-week treatment cycle.
16014864|NCT02775890|Behavioral|Eating wild game shot with lead bullets|Participants will eat meat harvested with lead bullets, prepare mince meat and eat at least a standard serving (>85 grams).
16014865|NCT02775877|Drug|Letrozole|
16014866|NCT02775877|Drug|clomiphene|
16014867|NCT02775877|Drug|HMG|
16014868|NCT02775864|Drug|Antipsychotic|New initiation of any antipsychotic medication
16014869|NCT02775864|Drug|Antidepressant|New initiation of any antidepressant medications
16014870|NCT02775864|Drug|Benzodiazepine|New initiation of any benzodiazepine
16014871|NCT02775864|Drug|Mood stabilizer|New initiation of lithium or any mood stabilizing anti-epileptic drug
16014872|NCT02775851|Biological|Pembrolizumab|Given IV
16014873|NCT02775851|Procedure|Therapeutic Conventional Surgery|Undergo surgical resection
16014874|NCT02775838|Drug|Indocyanine green|perioperative application of Indocyanine green (ICG)
16014875|NCT02775825|Other|survey|
16014876|NCT02775812|Drug|Cisplatin|Given IV
16014877|NCT02775812|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16014878|NCT02775812|Other|Laboratory Biomarker Analysis|Correlative studies
16014879|NCT02775812|Biological|Pembrolizumab|Given IV
16014880|NCT02775799|Other|Registration|Registration according to approved data sets
16014881|NCT02775786|Other|MRIs with and without intravenous contrast (up to 2)|Participants will undergo up to two MRIs with and without intravenous contrast. The first MRI will be performed using an extracellular contrast agent and the second 1-14 days later, with a macromolecular contrast agent. If patient cannot undergo the second MRI for any reason eg. not enough time before surgery, one MRI with either contrast agent will still be used for analysis.
16014882|NCT02775773|Drug|Tranexamic Acid|2 vials ( =1 gram) of Tranexamic Acid slow intravenous infusion administered within 5 minutes from the delivery (third stage after labor)
16014883|NCT02775773|Drug|Oxytocin|2 vials (=10 IU/International Unit) of Oxytocin administered intramuscularly within 5 minutes from the delivery (third stage after labor)
16014884|NCT02775760|Behavioral|Cardiovascular endurance|Physical exercise at the Boston University Fitness and Recreation Center
16014885|NCT02775760|Behavioral|Strength, balance, and flexibility|Physical exercise at the Boston University Fitness and Recreation Center
16014886|NCT02775747|Biological|platelet rich plasma gel|Platelet rich plasma is prepared from fresh whole blood which is collected from a peripheral vein stored in acid citrare dextrose solution A (ACD-A)anticoagulant and processed to increase platelets by separating various components of blood
16014887|NCT02775747|Biological|saline|64 controlled women with recurrent cesarean section and fullfit to all inclusion and exclusion craiteria will reseve saline injection at time of wound closure
16014888|NCT02775734|Drug|N-acetyl-cysteine|N-acetyl-cysteine + Clomiphene citrate + Laparoscopic ovarian drilling
16014889|NCT02775734|Drug|Clomiphene citrate|Clomiphene citrate + Laparoscopic ovarian drilling
16014890|NCT02775721|Other|Nursing Education related to Gastrostomy Tube Care|The research nurse will provide educational intervention at each study visit utilizing the nursing process.
16014928|NCT02775435|Drug|Carboplatin|IV infusion Carboplatin dose should not to exceed 900 mg.
16014891|NCT02775721|Other|Speech Therapy Education and Evaluation|Speech therapy will be conducted per standard of care, the protocol does not dictate the frequency or treatment plan of care. Speech therapy and evaluation is assessed per the attending speech therapist. The study team will collect all data related to speech therapy education and evaluation at each study visit per protocol. All collected data will be utilized in final protocol analysis.
16014892|NCT02775721|Other|Nutritional Therapy Education and Evaluation|Nutritional therapy will be conducted per standard of care, the protocol does not dictate the frequency or treatment plan of care. Nutritional therapy and evaluation is assessed per the attending dietitian. The study team will collect all data related to nutritional therapy education and evaluation at each study visit per protocol. All collected data will be utilized in final protocol analysis.
16014893|NCT02775721|Other|Quality of Life Questionnaire C30 version 3|30-item instrument that measures the Health Related Quality of Life (HRQoL) in a wide range of cancer patient populations.
16014894|NCT02775721|Other|Quality of Life Questionnaire EORTC QLO - H&N35|35-item instrument that measures the Health Related Quality of Life specific to Head and Neck cancer patient populations.
16014895|NCT02775708|Device|Pillcam endoscopy system|
16014896|NCT02775695|Drug|Doxycycline|Treatment with doxycycline hyclate will be administered as an oral agent on an outpatient basis. Patients will receive doxycycline 100 mg twice daily for a period of 8 weeks (56 days). Upon registration (baseline) and at the first, third, and fifth days of doxycycline therapy, patients will be seen to obtain trough serum concentrations for pharmacokinetic studies. Additional serum levels will be checked on days 8, 15, 22 and 29.
16014897|NCT02775630|Procedure|hypnosis|It will be proposed to the patient to participate in a study to assess the tolerance of Examination under hypnosis The examination is then conducted in endoscopy room. The patient will benefit from an induction technique of hypnosis by a doctor trained in hypnosis and local anesthesia performed by the endoscopist. In the control group, only local anesthesia is practiced by the endoscopist. The waning, it will ask the patient and endoscopist to complete an evaluation form tolerance of the review
16014898|NCT02775617|Drug|Ivermectin|Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Ivermectin will be offered as a a single dose 200μg/kg on Day 1 and Day 8.
16014899|NCT02775617|Drug|Azithromycin|Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Azithromycin will be offered as single dose of 30mg/kg, max 2G.
16014900|NCT02775617|Drug|Permethrin|Participants will be offered treatment for both yaws and scabies either in parallel or in sequence. Individuals with a contra-indication to ivermectin will be offered Permethrin instead.
16014901|NCT02775604|Behavioral|Video based/Therapists' rating of comprehensive-home-fall-hazard-checklist (vt-CHFHC)|The participant will use GoPro technology and follow standardized instructions to inspect each room of their house. They will navigate through their home wearing the GoPro camera, recording images about their home and their usual activities and use a talk-aloud approach to describe what they are doing and seeing. The evaluator will provide no feedback during the assessments.
16014902|NCT02775604|Behavioral|Paper based/Patient self-rating of comprehensive-home-fall-hazard-checklist (pp-CHFHC)|A paper version of CHFHC and other self-reported documents will be completed by the participants in their homes based on standardized verbal instruction provided by the research staff.
16014903|NCT02775591|Drug|DA-9701|DA-9701 30mg Tablet
16014904|NCT02775591|Drug|DA-9701 placebo|Placebo pill manufactured to mask DA-9701 30mg Tablet
16014905|NCT02775578|Procedure|Coronary Artery Bypass Grafting|Using coronary artery bypass grafting surgery as the coronary revascularization therapy for patients enrolled.
16014906|NCT02775578|Procedure|Percutaneous Coronary Intervention|Using percutaneous coronary intervention as the coronary revascularization therapy for patients enrolled.
16014907|NCT02775578|Procedure|Hybrid Coronary Revascularization|Patients enrolled will take coronary artery bypass grafting surgery at first, then treated with percutaneous coronary intervention.
16014908|NCT02775565|Device|AngioVac|
16014909|NCT02775552|Behavioral|A&T community-based interventions|"Interpersonal communication delivered by health workers and community volunteers at the health post and during home visits to:
~- Increase mothers' knowledge about adequate child feeding practices
~Interpersonal communication delivered by agricultural extension workers to:
~- Increase fathers' knowledge about nutrition-sensitive agriculture and child feeding
~Community mobilization activities to:
~Raise awareness of child feeding practices among community members, and increase support to mothers (enhanced community conversations)
~Increase mothers' knowledge about preparation of complementary foods (cooking demonstrations)
~Raise awareness of adequate child feeding during fasting among family and community members (church sermons)
~Enhanced training of government health and agricultural extension workers in infant and young child feeding to:
~Improve their ability to provide timely and appropriate information and support to mothers and families"
16014910|NCT02775552|Behavioral|Mass media|Radio campaign - radio drama series, spots, and jingles
16014911|NCT02775539|Drug|Mirabegron|Patients will receive 50 to 200 mg of mirabegron once a day during 16 weeks. Dose will be titrated during the first 8 weeks.
16014912|NCT02775539|Drug|Placebo|
16014913|NCT02775526|Procedure|TOT|70 patients
16014914|NCT02775526|Procedure|TVT|70 patients
16014915|NCT02775526|Procedure|Burch Colposuspension|70 patients
16014916|NCT02775500|Drug|apremilast|Comparison of women exposed during pregnancy versus women who are not exposed to apremilast
16014917|NCT02775474|Drug|Use of Intraoperative Intravenous Methadone|The intervention group will be given intravenous methadone at a fixed induction dose (0,15 mg / kg) and intraoperative boluses as judged necessary by the anesthesiologist
16014918|NCT02775474|Drug|Use of Intraoperative Intravenous Fentanyl|The active control group will be given intravenous fentanyl at a fixed induction dose (6 mg / kg) and intraoperative boluses as judged necessary by the anesthesiologist
16014919|NCT02775448|Drug|Carduus marianus 6cH|
16014920|NCT02775448|Drug|Carduus marianus 12cH|
16014921|NCT02775448|Drug|Carduus marianus 30cH|
16014922|NCT02775448|Drug|Placebo|
16014923|NCT02775448|Behavioral|Exercise|aerobic exercise, 30 minutes, daily
16014924|NCT02775448|Other|Diet|1600 calories
16014925|NCT02775435|Biological|Pembrolizumab|IV infusion
16014926|NCT02775435|Drug|Paclitaxel|IV infusion
16014927|NCT02775435|Drug|Nab-paclitaxel|IV infusion
16014930|NCT02775422|Biological|Serological Test s for the Virus Chicken Pox Virus|
16014931|NCT02775409|Procedure|Subcutaneous placement|The tissue expander will be placed above the muscle.
16014932|NCT02775409|Procedure|Submuscular placement|The tissue expander will be placed below the muscle
16014933|NCT02775396|Device|Spectacle lens|Wearing a spectacle lens design with corrective prescription power while playing computer game using an iPad tablet computer. Two lens designs were prescribed for each participant: the conventional single-vision lens and a new progressive addition lens designed for handheld digital device. Primary outcome measures were performed immediately after each lens delivery and one-month of lens wear.
16014934|NCT02775383|Other|Therapeutic|Observational Study
16014935|NCT02775370|Drug|Apatinib Mesylate|Apatinib Mesylate will be administered orally at 500 mg once daily for 5 consecutive days, and this was followed by a 2-day rest every week; each cycle consisted of 28 days
16014936|NCT02775357|Behavioral|Measurement and communication of HIV risk|Measurement and communication of HIV risk in the context of HIV testing and counseling to inform HIV risk reduction counseling
16014937|NCT02775357|Behavioral|Standard HIV testing and counseling|Participants received HIV testing and counseling following standard Ministry of Health guidelines
16014938|NCT02775344|Device|Three dimension laparoscopy|Surgery will be performed either with three dimension laparoscopy or two dimension laparoscopy.
16014939|NCT02775331|Other|Shift planning with self-rostering and shift ergonomics|Employees working in shift planning units (clusters) using an interactive shift planning software (Titania1) with sub-tools for individual shift planning (self-rostering) and an option for shift ergonomics evaluation to both the shift planner and the employees
16014940|NCT02775331|Other|Shift planning with shift ergonomics|Employees working in shift planning units (clusters) where shift planners use a non-interactive shift planning software (Titania2) providing guidance for health-supporting shift ergonomics.
16014941|NCT02775318|Procedure|Stellate Ganglion Block|Under aseptic conditions, transducer is placed on the surface of the neck at the level of C6 vertebrae. The internal jugular vein, carotid artery, thyroid gland, trachea, C6 vertebrae, transverse process of C6, esophagus , longus colli with its covering prevertebral fascia and esophagus are visualized. A 25-gauge Quincke spinal needle was inserted paratracheal towards the middle of the longus colli muscle. The endpoint of the injection was the ultrasound image of the tip of the needle as it penetrates the prevertebral fascia covering the longus colli muscle. The drug is then injected and spread of drug is visualized in real time.
16014942|NCT02775318|Drug|Bupivacaine|10 ml of 0.5% injection bupivacaine is used for giving stellate ganglion block on the side of cerebral vasospasm
16014943|NCT02775318|Procedure|Transcranial Doppler|The principle on which the TCD works is that with arterial narrowing, the blood flow velocity within the vessel increases. A good correlation has been found between the TCD blood flow velocities and vasospasm. The MCA velocity greater than 120 cm/sec indicates mild vasospasm , velocity greater than 130 cm/sec indicates moderate vasospasm and velocity greater than 200 cm/sec indicates severe vasospasm.
16014944|NCT02775318|Procedure|Digital Subtraction Angiography|Digital subtraction angiography is a direct method for the assessment of vessel caliber. It generates high resolution, high contrast and low artifact images using digital subtraction technology. Direct visualization using DSA is the gold standard for the radiographic diagnosis of cerebral vasospasm
16014945|NCT02775305|Behavioral|Frail|"Slowness/weakness: Physical therapy(PT) strength and gait training. A standardized strengthening program will be prescribed, to be performed at home. Additional in-person PT training will be provided to those who are severely deconditioned .
~Weight loss/malnutrition: A licensed nutritionist specializing in kidney disease will meet with participants for 3 one-hour one-on-one nutritional counseling.
~Low physical activity: Participants will receive individualized walking recommendations using a pedometer. Walking activity will be assessed weekly, and new goals for increasing steps in the following week will be set.
~Exhaustion: Those who meet criteria for severe depression using the center for epidemiologic studies depression (CES-D) scale will be immediately referred to psychiatry for counseling for patient safety. All others will participate in cognitive behavioral coping techniques."
16014946|NCT02775292|Biological|Aldesleukin|Given SC
16014947|NCT02775292|Drug|Cyclophosphamide|Given IV
16014948|NCT02775292|Drug|Fludarabine Phosphate|Given IV
16014949|NCT02775292|Other|Laboratory Biomarker Analysis|Correlative studies
16014950|NCT02775292|Biological|Nivolumab|Given IV
16014951|NCT02775292|Biological|NY-ESO-1 Reactive TCR Retroviral Vector Transduced Autologous PBL|Given IV
16014952|NCT02775292|Biological|NY-ESO-1(157-165) Peptide-pulsed Autologous Dendritic Cell Vaccine|Given ID
16014953|NCT02775292|Procedure|Positron Emission Tomography|Correlative studies
16014954|NCT02775266|Other|Alpha lipoic acid|Scaling and root planing will be done at baseline and systemic antioxidant Alpha lipoic acid 1800mg/day in 3 divided doses for a period of 3 months.
16014955|NCT02775266|Procedure|Scaling and Root planing|Scaling and root planing will be done at baseline.
16014956|NCT02775253|Other|Chronic cold acclimation|
16014957|NCT02775240|Drug|Digoxin|0.5 mg (2 x 0.25 mg) Digoxin oral dose
16014958|NCT02775240|Drug|Maribavir|200mg twice a day for 8 days
16014959|NCT02775240|Drug|Dextromethorphan|30 mg oral dose
16014960|NCT02775227|Drug|Hydrocortisone|
16014961|NCT02775227|Drug|Pasireotide|
16014962|NCT02775214|Device|Video Laryngoscopy|
16014963|NCT02775201|Procedure|Plantaris release under ultrasound guidance|In patients diagnosed with Achilles tendinopathy the plantaris tendon will be released using a small incision at the medial ankle under ultrasound guidance by a consultant radiologist
16014964|NCT02775201|Procedure|Plantaris excision surgically|In patients diagnosed with Achilles tendinopathy the plantaris tendon will be excised in theatre by a consultant orthopaedic surgeon
16014965|NCT02775188|Device|interACTION|
16014966|NCT02775188|Other|Standard of Care Physical Therapy|
16014967|NCT02775175|Behavioral|Modified Ramadan Fasting|The intervention aims to provide knowledge about fasting and its effects on the body/mind, and health advice around nutrition to support health and well-being of participants during Ramadan.
16014968|NCT02775162|Device|Normothermic Machine Perfusion (NMP)|
16014969|NCT02775162|Other|Standard of Care (Ice)|
16014970|NCT02775149|Other|Collection of saliva samples|Collection of saliva samples
16086294|NCT02262624|Drug|Telmisartan|
16014971|NCT02775149|Other|Visual detection of BEWE-index|Visual detection of BEWE-index
16014972|NCT02775136|Device|HS-1000 recording|
16014973|NCT02775123|Device|Cytosorb|A cytoadsorbent cardridge (Cytosorb) will be added to the extra-corporeal circuit (CPB).
16014974|NCT02775110|Other|Natalizumab discontinuation|Patients will be randomized to one of two groups: The Immediate Discontinuation Group (stop natalizumab immediately and continue with new DMT 1 month afterward) and the Taper-off Group (two additional infusions of natalizumab, one at 6 weeks and the next at 8 weeks following discontinuation. A new DMT will be initiated within 2 months of final natalizumab infusion).
16014975|NCT02775097|Device|OCT|OCT for all Arms
16014976|NCT02775084|Dietary Supplement|Fish Oil|4 capsules twice daily with food for 6 weeks
16014977|NCT02775084|Dietary Supplement|Olive Oil|4 capsules twice daily with food for 6 weeks
16014978|NCT02775058|Device|synergoss Pxx|dental grafting
16014979|NCT02775045|Other|Observation Period|8 week observational period
16014980|NCT02775032|Behavioral|Advance care planning conversations between patients and their GP|
16014981|NCT02775019|Dietary Supplement|Lactobacillus reuteri|2 x daily repeated consumption of a lozenge containing 10E9 CFU Lactobacillus reuteri for 42 days
16014982|NCT02775019|Dietary Supplement|Placebo|2 x daily repeated consumption of a lozenge being void of Lactobacillus reuteri for 42 days
16014983|NCT02775006|Drug|Docetaxel|75mg/m2
16014984|NCT02775006|Drug|Erlotinib|150mg/day
16014985|NCT02774993|Drug|Doxycycline|
16014986|NCT02774993|Drug|placebo|
16014987|NCT02774980|Behavioral|Recurrent depression|
16014988|NCT02774967|Procedure|root coverage|Root coverage with acellular dermal matrix using two techniques: advanced positional flap ou tunneling,
16014989|NCT02774954|Behavioral|Change the Cycle|See previous response
16014990|NCT02774941|Device|Jet Nebulizer|Standard single patient-use small volume JN (AirLife™ Sidestream® High-Efficiency Nebulizer, CareFusion, Yorba Linda, CA)
16014991|NCT02774941|Device|Vibrating Mesh Nebulizer|Vibrating Mesh Nebulizer (Aerogen® Solo with Ultra adapter, Aerogen Ltd, Galway, Ireland)
16014992|NCT02774902|Drug|TAK-438|TAK-438 tablets
16014993|NCT02774902|Drug|Clarithromycin|Clarithromycin tablets
16014994|NCT02774889|Behavioral|Stepping Online|"Stepping Online is a password-protected website with Stepping On graduates, whose groups are randomized to Stepping Online and will have access to and training in a password-protected website. The website includes:
~Fall prevention tips
~Fall prevention exercise videos with narrations for proper technique and safety precautions
~Guest expert videos with online access to the guest expert to ask questions
~Tools to set exercise goals, get reminders and track progress
~Access to a fall prevention specialist for personal feedback and suggested group homework
~Group discussion and messaging (one-to-one and with their fellow Stepping On workshop participants group, or with all Stepping Online participants and leaders)
~Fall prevention resources"
16014995|NCT02774876|Device|Patient's insulin pump|The patient's insulin pump will be used to regulate glucose levels.
16014996|NCT02774876|Drug|Insulin|Patient's usual fast-acting insulin analog will be used.
16014997|NCT02774876|Device|Dexcom G4 Platinum glucose sensor|The Dexcom G4 Platinum glucose sensor will be used to measure glucose levels.
16014998|NCT02774876|Other|Single-hormone closed-loop|Interventions will be undertaken 1 to 5 days after sensor insertion. Subjects will be admitted at IRCM at 6:30 am in a fasting state. At 7:00, single-hormone closed-loop will be initiated. At 8:00, if glucose levels are between 3.5 and 12.5 mmol/L, the meal will be served. Patients will have 20 minutes to consume the meal. If glucose levels are not in this target range, the meal will be delayed for a maximum of 45 minutes. If after 45 minutes, glucoses levels are still not between 3.5 and 12.5 mmol/L, the test will be cancelled and rescheduled. The test meals will be: 1) 75g of CHO; 2) 75g of CHO + 35g of protein; 3) 75g of CHO + 35g of fat; or 4) 75g of CHO + 35g of protein + 35g of fat. The intervention day will end at 13:00.
16014999|NCT02774863|Other|Home passages|Three home passages between the 2nd and 3rd months of follow up.
16015000|NCT02774837|Drug|Tenofovir disoproxil|Tenofovir disoproxil 300mg once daily for 96 weeks
16015001|NCT02774837|Drug|Telbivudine|Telbivudine oral tablets 600mg once daily for 96 weeks
16015002|NCT02774811|Drug|Prostaglandin analogue|Topical therapy
16015003|NCT02774811|Procedure|Selective laser trabeculoplasy|Laser therapy into drainage angle
16015004|NCT02774811|Device|laser|
16015005|NCT02774785|Device|MarginProbe|Surgery to take place as per standard care. When the surgery is nearly concluded, patient to be randomised. If randomised to device arm, the MarginProbe device will be used on the outer edge of the tumour and shavings. If the MarginProbe device indicates that cancer is detected, a further shaving is to be taken. Surgery then to be concluded as per standard care.
16015006|NCT02774759|Device|Accelerometer|Participant wears an accelerometer for 7 days before baseline visit to record activity levels, and again before their 6 month visit.
16015007|NCT02774759|Behavioral|Questionnaires|"Questionnaires completed at baseline regarding quality of life and diet.
~Questionnaires completed at 3 and 6 months regarding quality of life, diet, physical activity, etc."
16015008|NCT02774759|Behavioral|Fitness Test|Fitness test given covering various physical activities at baseline and at 6 month visit.
16015009|NCT02774759|Behavioral|Resistance Training|Physical activity guidelines workbook distributed along with activity monitor. Participants receive resistance bands to perform resistance exercises. Exercise handouts and an iPad mini with training videos used to video chat with a research team member. Information from wireless scale and Fitbit sent to Fitbit website to monitor levels.
16015010|NCT02774759|Behavioral|Aerobic Exercise|Participants placed into an exercise plan focused on physical activity only. Physical activity guidelines workbook distributed along with activity monitor.
16015011|NCT02774759|Behavioral|Telephone Coaching/Phone Calls|Participants called 4 times during the first month, 2 times during the second month, and 1 time per month for the rest of the study. Participants also receive a follow-up call at the end of the study.
16015012|NCT02774759|Behavioral|Video Chat Sessions|Video chatting between the research team and participants occurs 2 times per month during the first and third months, when new exercises are introduced. Video chatting offered monthly as needed by participants during months 2, 4, 5, and 6.
16015015|NCT02774733|Device|spirometer;Intraocular pressure;Color doppler imaging|
16015016|NCT02774720|Behavioral|Centre-based exercise|Participants will come to a centre (University of Waterloo or Toronto Rehabilitation Institute) for a one-hour, small group exercise class each week. The classes will include progressive aerobic and resistance exercise. They will be prescribed additional exercise to be performed independently (either at home or in the community).
16015017|NCT02774720|Behavioral|Home-based exercise|Participants will be prescribed aerobic and resistance exercise to be performed independently (either at home or in the community). They will receive monthly phone calls to discuss achievements and barriers and to tje adjust exercise prescription.
16015018|NCT02774694|Device|"nociceptive flexion reflex (NFR) threshold (Paintracker, Dolosys GmbH, Berlin, Germany)"|"measurement of the NFR threshold using the Paintracker device"
16015019|NCT02774681|Procedure|Cognitive Assessment|Ancillary studies
16015020|NCT02774681|Drug|Palbociclib|Given PO
16015021|NCT02774681|Procedure|Quality-of-Life Assessment|Ancillary studies
16015022|NCT02774681|Biological|Trastuzumab|Given IV
16015023|NCT02774668|Other|"Grab-and-Go meal plan"|"The Grab-and-Go meal plan will provide Atkins shakes and bars for breakfast, lunch, and snacks. For dinner, the participant will receive a freshly-prepared meal. There will be no difference in terms of calories or nutrient composition between Grab-and-Go meal plan versus Jump-Start meal plan.
~The amount of weight loss caused by these two meal plans is not expected to differ."
16015024|NCT02774668|Other|"Jump-Start meal plan"|"The Jump-Start plan will provide Atkins frozen meals at breakfast, lunch and dinner and these meals will be supplemented with fresh salads and vegetables. There will be no difference in terms of calories or nutrient composition between Grab-and-Go meal plan versus Jump-Start meal plan. The amount of weight loss caused by these two meal plans is not expected to differ."
16015025|NCT02774655|Device|Pai APP|prescribed 100 PAI weekly
16015026|NCT02774655|Device|FitBit APP|prescribed 10000 steps daily
16015027|NCT02774642|Behavioral|CBTI-PE|Integrates CBT-I and PE with the goal of enhancing both insomnia and PTSD outcomes. Integrated treatment will be delivered in 14 90-minute weekly sessions. CBTI-PE starts with VA rollout CBT-I for the first 3 weeks with a focus on the effects of PTSD on insomnia. PE protocol (psychoeducation) begins on week 4 of treatment and both treatments overlap till week 6 when CBT-I ends and the active treatment of PE begins (i.e., imaginal and in-vivo exposures). However, CBT-I sleep diary review and sleep time adjustment will continue till the end of treatment to increase adherence
16015028|NCT02774642|Behavioral|Hygiene-PE|The investigators have included a non-active sleep control arm (3 Sessions)to allow for the dose response of 14 90 minute sessions. The non-active sleep control condition used in this study is a manualized protocol developed to exclude the active components of standard CBT-I treatment. Hygiene includes presentation of sleep hygiene education and reviewing daily stressors that may impact sleep before starting PE on week 4.
16015029|NCT02774629|Other|prick and patch test|The cases are pricked and patched with local food allergen extract at different storage times (0, 3 and 6 months after preparation)
16015030|NCT02774616|Device|Ilivia ICD Family|pre-defined device programming, measurements and follow-up schedule
16015031|NCT02774616|Device|Plexa ICD lead|predefined follow-up schedule
16015032|NCT02774603|Other|Aquatic Locomotor Training|
16015033|NCT02774603|Other|Land Locomotor Training|
16015034|NCT02774590|Drug|Timolol|Apply timolol on half of the participant's face for 8 weeks. Then treat both sides of face for 8 weeks.
16015035|NCT02774577|Other|whole body vibration training in vibrating platform in young|
16015036|NCT02774577|Other|whole body vibration training in vibrating platform in elderly|
16015037|NCT02774564|Drug|BIA 3-202|Nebicapone tablets 50 mg, oral administration
16015038|NCT02774564|Drug|Placebo|Nebicapone matching placebo tablets
16015039|NCT02774564|Drug|Sinemet®|Sinemet® CR 200/50 (levodopa 200 mg / carbidopa 50 mg) tablets
16015040|NCT02774551|Behavioral|Physical activity intervention group|150 minutes of minimum intensity activity during a week (e.g. walking, swimming) and five strength training exercises (10 repetitions and 2 sets of: squats, wall push ups, rowing with resistance band, shoulder press with resistance band, hip abduction) targeting the major muscle groups to do twice a week.
16015041|NCT02774538|Other|Agreement between oral and cervical HPV infection|"A total of 165 women will have a Pap test and an oral brushing performed on the day of inclusion. Risk factors for oral HPV infection will be defined using a self-administered survey summarizing the demographics and sexual behaviors.
~A second oral brushing up to 18 months will be performed during a standard follow-up visit."
16015042|NCT02774525|Behavioral|Reinforcement for drug & alcohol abstinence|
16015043|NCT02774525|Behavioral|Parenting intervention|
16015044|NCT02774525|Behavioral|Treatment as usual (TAU)|Outpatient substance-abuse therapy plus drug & alcohol screening plus support for personal goal setting
16015045|NCT02774512|Drug|Nilotinib|Each patient will receive nilotinib 800 mg/day every day for 7 days. Study treatment will be taken twice a day (400 mg - 2 capsules) by oral route with an interval of approximately 12 hours between two doses and should not be taken with food. The entire capsule should be swallowed with water. No food should be consumed for 2 hours before taking the drug and for at least 1 hour after it.
16015046|NCT02774499|Drug|Methadone|0.3mg/kg of methadone given preoperatively (to maximum of 30mg)
16015047|NCT02774499|Drug|Placebo|equivalent volume (5mL) of syrup given preoperatively
16015048|NCT02774486|Device|IQP-AK-102|IQP-AK-102 has been qualified as a medical device (CE certificate has been ob- tained), class IIb, according to MDD 93/42/EEC, annex IX, rule 5.
16015049|NCT02774460|Drug|Zestril®|Treatment step up: 1-2 weeks (10 mg tablet) Target dose: 5-7 weeks (20 mg tablet)
16015050|NCT02774460|Drug|Atacand®|Treatment step up: 1-2 weeks (8 mg tablet) Target dose: 5-7 weeks (16 mg tablet)
16015051|NCT02774460|Drug|Norvasc®|Treatment step up: 1-2 weeks (5 mg tablet) Target dose: 5-7 weeks (10 mg tablet)
16015052|NCT02774460|Drug|Hydrochlorthiazide®|Treatment step up: 1-2 weeks (12,5 mg tablet) Target dose: 5-7 weeks (25 mg tablet)
16015053|NCT02774460|Drug|Treatment X|Each patient receives all four treatments, and in addition repeats two of the treatments, labeled X and Y. The repeated arms will be given with the same duration and dosing as the other arms.
16015054|NCT02774460|Drug|Treatment Y|Each patient receives all four treatments, and in addition repeats two of the treatments, labeled X and Y. The repeated arms will be given with the same duration and dosing as the other arms.
16015055|NCT02774460|Drug|Placebo|This is an unblinded placebo run-in which we use to generate baseline values. Each patient will initiate their participation with these 2 weeks of placebo treatment, taking 1 capsule daily.
16015056|NCT02774447|Procedure|ileostoma closure|The operation procedure is standardized as described above (see group description).The patients will be observed for 23 hours, and if there are no contraindications according to described criteria the patient can be discharged form the hospital, however all patients will have follow-up telephone contact on a daily basis with a nurse for the first week. Patients will meet the surgeon 3 days after discharge and after 4 weeks.
16015057|NCT02774434|Device|JM-105|Measurement of TcB via the JM-105 device
16015058|NCT02774421|Drug|Trastuzumab after SubQ GM-CSF|
16015059|NCT02774421|Drug|Trastuzumab in combination with SubQ GM-CSF|
16015060|NCT02774408|Device|Saturation sensitive backup ventilation|
16015061|NCT02774382|Drug|Vancomycin|Already incl. in arm description
16015062|NCT02774382|Drug|Fecal microbiota transplantation|Already incl. in arm description
16015063|NCT02774382|Drug|Rectal bacteriotherapy|Already incl. in arm description
16015064|NCT02774369|Behavioral|Physical exercise|Individualized aerobic intervention program
16015065|NCT02774369|Behavioral|Cognitive-behavioral therapy|Psychological intervention combining behavioral, cognitive, and educational strategies
16015066|NCT02774343|Drug|Pioglitazone|Subjects randomized to pioglitazone begin with a starting dose of 15 mg daily administered. The dose will be titrated up to 30mg on the second week and 45 mg on the third week of the study. Subjects will remain on 45 mg of pioglitazone until the end of week 12. At the end of week 12 the study medication will be discontinued.
16015067|NCT02774343|Drug|Placebo|Subjects randomized to placebo receive placebo capsules once daily across all twelve weeks of the study.
16015068|NCT02774343|Behavioral|Therapy|Cognitive-behavioral therapy 1 hour per week
16015069|NCT02774343|Behavioral|Contingency Management|Prize-based contingency management for attendance
16015070|NCT02774330|Other|Policy|This local policy change (i.e., the Minneapolis Staple Foods Ordinance) establishes minimum stocking criteria for a wide array of healthy foods as a requirement of food store licensing. To our knowledge, it is the first and only policy of its kind in the U.S. This Staple Foods Ordinance requires stores to stock specific types of foods in minimum quantities and varieties, including fruits and vegetables, low-fat dairy, and whole grains. A full list of all requirements can be found online through the City of Minneapolis: http://www.minneapolismn.gov/health/living/eating/staple-foods.
16015071|NCT02774317|Biological|Plasma|FFP (plasma frozen within 8 hrs of collection) or FP24 (plasma frozen within 24 hrs of collection)
16015072|NCT02774304|Device|arterial line|In mechanically ventilated patients systolic pressure variation will be captured and passive leg raising with positive result fluid filling will be initiated.
16015073|NCT02774304|Device|Cheetah®|In mechanically ventilated patients systolic pressure variation will be captured and passive leg raising with positive result fluid filling will be initiated.
16015074|NCT02774291|Biological|Aldesleukin|Given IV
16015075|NCT02774291|Biological|Anti-thyroglobulin mTCR-transduced Autologous Peripheral Blood Lymphocytes|Given IV
16015076|NCT02774291|Drug|Cyclophosphamide|Given IV
16015077|NCT02774291|Biological|Filgrastim|Given SC
16015078|NCT02774291|Drug|Fludarabine Phosphate|Given IVPB
16015079|NCT02774291|Other|Laboratory Biomarker Analysis|Correlative studies
16015080|NCT02774278|Drug|Erlotinib|Erlotinib will be administered at 150 milligrams (mg) orally daily until disease progression, unacceptable toxicity or death.
16015081|NCT02774265|Drug|VTE prophylaxis with Enoxaparin 30mg BID|Patients will receive Enoxaparin 30mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.
16015082|NCT02774265|Drug|VTE prophylaxis with Aspirin 81mg BID|Patients will receive Aspirin 81mg BID for DVT prophylaxis and will be followed to determine the efficacy, safety and cost when used for VTE prophylaxis in high-risk orthopedic traumas administered for the length of time indicated by standard of care based on the injury.
16015083|NCT02774252|Drug|BAY987521|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation number - Y49-103)
16015084|NCT02774239|Drug|Human normal immunoglobulin G (IgG)|"Study medication is available in the following forms: 5 mL (1 g IgG) in a 5 mL infusion bottle, 10 mL (2 g IgG) in a 10 mL infusion bottle, 20 mL (4 g IgG) in a 20 mL infusion bottle, 50 mL (10 g IgG) in a 50 mL infusion bottle.
~Patients will be receiving 2gm/kg (150gm for a 75kg patient) of 20% SCIG (Hizentra) infused over four weeks in a dose escalating manner."
16015085|NCT02774226|Drug|Tetrahydrobiopterin (BH4)|12 week intervention
16015086|NCT02774226|Dietary Supplement|Antioxidant Cocktail|12 week intervention
16015087|NCT02774213|Other|Questionnaires completion|
16015088|NCT02774213|Other|Clinical Pain Assessments|
16015089|NCT02774200|Drug|Apatinib|Apatinib 500 mg, po, qd, continuous medication for a period of eight weeks.
16015090|NCT02774187|Drug|Sorafenib|administration of Sorafenib
16015091|NCT02774187|Procedure|Hepatic arterial infusion chemotherapy|administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
16015092|NCT02774187|Drug|Folfox Protocol|Oxaliplatin , fluorouracil, and leucovorin
16015093|NCT02774161|Other|Ultrasound Tomography|Undergo B-mode ultrasound imaging
16015094|NCT02774148|Drug|IV Acetaminophen|The patient will receive 1,00mg IV Acetaminophen every 8 hours until 3 doses have been received post-operatively.
16015095|NCT02774148|Drug|PO Acetaminophen|The patient will receive 1,000mg po Acetaminophen every 8 hours.
16015096|NCT02774135|Other|direct occupational therapy intervention|Short term direct individual occupational therapy (9-12 weeks).Participants will receive occupational therapy intervention according to health law. The study will document the therapeutic intervention implemented in practice using the Documentation of Occupational Therapy Session during Intervention (DOTSI).
16015226|NCT02773199|Drug|Spinal Anesthesia with Bupivacaine|Spinal Anesthesia with heavy bupivacaine 0.5% is provided.
16015097|NCT02774122|Device|CAABT|CAABT was an innovative tinnitus intervention which based on neural science and cochlear plastic research and aimed to reprogram the central auditory system to neutralize the discordant responses of the dysfunctioning cochlea via acoustic beaming stimuli.
16015098|NCT02774122|Device|masking therapy|Masking intervention was a standard monophone tinnitus masking therapy.
16015099|NCT02774109|Dietary Supplement|Fish oil|Five 1000mg fish oil soft capsules per day (each capsule containing 350mg EPA and 250mg DHA) for 8 weeks
16015100|NCT02774109|Dietary Supplement|Placebo|Five 1000mg sunflower oil soft capsules per day for 8 weeks
16015101|NCT02774109|Procedure|Hotpacking|Hotpacking 15min on low back, three times a week for 8 weeks
16015102|NCT02774109|Procedure|Transcutaneous electrical nerve stimulation (TENS)|Transcutaneous electrical nerve stimulation (TENS) 15min on low back, three times a week for 8 weeks
16015103|NCT02774096|Drug|xenon|
16015104|NCT02774083|Behavioral|Feuerstein Program|Mediated learning cognitive enhancement program
16015105|NCT02774083|Behavioral|Adler Program|Social and emotional group program
16015106|NCT02774070|Radiation|Plain X-ray|antero-posterior, lateral neutral, flexion, extension and open-mouth views
16015107|NCT02774070|Radiation|Magnetic resonance imaging|Magnetic resonance imaging sagittal T1W,T2W and STIR, axial T1W and coronal T2W and post contrast sagittal and axial sequences
16015108|NCT02774057|Drug|Captafer®|"2 pills daily. Contains
~Vitamin C, known for its property to facilitate iron absorption by reducing iron to the reduced ferrous state necessary for uptake;
~Vitamin E, an antioxidant, along with vitamin C it protects Fe++;
~Folic acid, necessary to prevent megaloblastic anemia and abnormalities in the fetal nervous system, vital during pregnancy;
~Zinc and Copper which act in different mitochondrial cytochromes-dependent systems and contribute to the use of iron by the biological systems"
16015109|NCT02774057|Drug|Iron Sulfate|195 mg Iron supplement
16015110|NCT02774044|Drug|Cadisurf|Cadisurf Intratracheal suspension is a sterile, non-pyrogenic pulmonary surfactant intended for intratracheal use only. It is a natural lung extract containing phospholipids and surfactant-associated proteins. The resulting composition provides 25 mg/mL phospholipids and less than 1.0 mg/ml protein. It is suspended in 0.9% sodium chloride solution. Cadisurf contains no preservatives. Each ml of Cadisurf contains 25 mg of phospholipids. It is a creamy white suspension supplied in single-use glass vials containing 8 mL (200 mg phospholipids).
16015111|NCT02774044|Drug|Survanta|
16015112|NCT02774031|Device|Aisys with Et control|
16015113|NCT02774031|Device|Aisys conventional|
16015114|NCT02774031|Device|Flow-i with ACG|
16015115|NCT02774031|Device|Flow-i conventional|
16015116|NCT02774018|Behavioral|Mindfulness-Based Stress Reduction (MBSR) program|
16015117|NCT02774005|Drug|Idebenone|
16015118|NCT02773992|Behavioral|The IoT|"For the IoT group, three plus two type pulmonary nodule diagnosis： ① gather information: smoking history, tumor personal and family history, copd history, etc.; ② noninvasive examination: tumor markers, lung function and chest low-dose CT thin layer; ③ information mining in-depth:through the software for three-dimensional reconstruction of pulmonary nodules, depth excavation, accurate calculation of the density of the volume, assessment of the surrounding and infiltration of lung nodules and related vascular growth status; two solutions: ① Pathological diagnosis in highly suspected patients: fiber bronchoscope, ultrasonic bronchoscope, thoracoscope and CT guided percutaneous lung biopsy, etc.; ② Close scientific follow-up to the person who can not be qualitative: doctors follow up and manage patients scientifically in accordance with the follow-up management tables through the Internet of things platform."
16015119|NCT02773979|Drug|Chloroquine|Administered as 600mg PO, day 1, 300mg PO days 8, 15, 22.
16015120|NCT02773979|Biological|PfSPZ (NF54) Challenge|Cryopreserved Plasmodium falciparum (Pf) fully infectious sporozoites (SPZ) that have been developed to be used to infect volunteers in controlled human malaria infection (CHMI) to assess the efficacy of antimalarial drugs and vaccines. The PfSPZ (NF54) Challenge contains a laboratory malaria strain isolated from a Dutch traveler to Africa.
16015121|NCT02773979|Other|Placebo|Placebo
16015122|NCT02773966|Radiation|Kypho-IORT|During kyphoplasty/vertebroplasty a intraoperative radiotherapy of the affected vertebrae is done with a miniature X-ray generator (INTRABEAM®, Carl Zeiss, Surgical, Oberkochen, Germany). The prescription dose will be 8 Gy in a distance of 13 mm from the isocenter of the radiation source. IORT will take about five minutes. After radiation the applicator will be removed and the operation will be finished as usual.
16015123|NCT02773966|Radiation|EBRT|The external beam radiotherapy will be usually carried out as an outpatient procedure. All patients will receive a planning CT before the first irradiation. EBRT will be performed with 30 Gy, added in 3 Gy per fraction or 8 Gy single dose (only for international study centers, not permitted in Germany) on a conventional linear accelerator (LINAC).
16015124|NCT02773953|Device|T4PTelemonitoring|addition of a Telemonitoring unit on the CPAP line to standard care.
16015125|NCT02773953|Device|CPAP|CPAP treatment for treatment of obstructive sleep apnea syndrome
16015126|NCT02773940|Device|ClariCore System|Biopsy tissue and correlative spectral data will be acquired using the ClariCore System during a patient's already scheduled radical retropubic prostatectomy (RRP) surgery.
16015127|NCT02773927|Drug|Metformin|Metformin in tablet presentation of 500 mg
16015128|NCT02773927|Dietary Supplement|Agave inulin|Inulin in powder obtained from agave plant, it was given to each patient a full 10 mg container.
16015129|NCT02773927|Other|Placebo of agave inulin|Calcinated magnesia powder
16015130|NCT02773927|Other|Metformin placebo|Calcinated magnesia tablet
16015131|NCT02773914|Other|Comprehensive Geriatric Assessment|Comprehensive Geriatric Assessment intervention
16015132|NCT02773901|Device|HS-1000|
16015133|NCT02773888|Device|HS-1000|
16015134|NCT02773875|Device|Artificial pancreas system (Algorithm + CGM + pump)|The AP system using fault detection algorithms will determine whether insulin infusion problems are occurring and may prevent severe hyperglycemia due to its predictive nature
16015135|NCT02773862|Device|HS-1000|
16015136|NCT02773849|Biological|INSTILADRIN|
16015137|NCT02773836|Other|Questionnaire|Questionnaire: To evaluate the impact of the implementation of the EU Tobacco Products Directive (TPD) and Framework Convention on Tobacco Control (FCTC)
16015138|NCT02773823|Behavioral|Intervention group|Diet instruction for 3-4 times/semester,exercise 60min/day for 5d/week for 8 months.
16015139|NCT02773810|Other|Integrated Family Planning Services|Women who agree to enrollment will undergo our intervention, which will include an educational intervention and free on-site provision of all reversible contraceptive options, including LARC. This educational 5 intervention will be a one-on-one educational session on all available methods of contraception, with an emphasis on the safety and efficacy of long-acting reversible contraception (LARC) and the importance of planning a pregnancy in women with medical conditions requiring anticoagulation. A provider (clinic officer, nurse or physician) trained in family planning counseling and provision will provide all counseling and discussions in Kiswahili. Women will then be offered free, on-site provision of whichever contraceptive method they choose by a trained provider.
16015140|NCT02773797|Drug|IN-DEX 1.0 mcg/kg, intranasal saline|
16015141|NCT02773797|Drug|IN-DEX 1.5 mcg/kg, intranasal saline|
16015142|NCT02773797|Drug|Placebo - Saline|
16015143|NCT02773784|Other|immunohistochemistry and/or FISH|Patients with invasive breast cancer diagnosed by core needle biopsy (CNB) and not to receive neoadjuvant system therapy are eligible for this study. ER, PR, Her-2 and Ki67 are determined by immunohistochemistry (IHC) in CNB and surgical specimen. FISH analysis will be carried out in all HER2 2+ samples.
16015144|NCT02773771|Dietary Supplement|beta-hydroxy-beta-methylbutyrate|HMB is a leucine metabolite that may also be a potent mediator of anabolic processes in skeletal muscle; subjects will not receive >3g of HMB/ day.
16015145|NCT02773771|Dietary Supplement|Placebo|The placebo is cornstarch and will be mixed in with Vital HP. The solution will look identical to the intervention arm.
16015146|NCT02773771|Dietary Supplement|Vital HP®|Vital HP® is a form of enteral nutrition a part of the Massachusetts General enteral formulary
16015147|NCT02773758|Other|Stannous Fluoride Dentifrice|Experimental dentifrice containing 0.454%w/w stannous fluoride (1100ppm fluoride)
16015148|NCT02773758|Other|Sodium monofluorophosphate Dentifrice|Dentifrice containing 0.76% w/w sodium monofluorophosphate (1000ppm fluoride)
16015149|NCT02773745|Behavioral|Aquatic Prehab|Pool therapy
16015152|NCT02773719|Other|True Biofield therapy|
16015153|NCT02773719|Other|Fake Biofield therapy|
16015154|NCT02773706|Other|Automated Psychology Services|The automated screening tool determines a positive or negative screen, then informs the clinician, and also automates a psychology visit.
16015155|NCT02773706|Other|Notification of Subspecialist|The automated screening tool determines a positive or negative screen, then informs the clinician.
16015156|NCT02773693|Behavioral|Cognitive Processing Therapy-Cognitive Only (CPT)|Twice weekly CPT over 6 weeks.
16015157|NCT02773693|Behavioral|Cognitive Behavioral Therapy of Insomnia and Nightmares (CBTin)|Cognitive behavioral therapy of insomnia and nightmares weekly over 6 weeks.
16015158|NCT02773693|Behavioral|Continuation Cognitive Processing Therapy-Cognitive Only (CPT)|Once weekly continuation CPT over 6 weeks.
16015159|NCT02773680|Device|"electrical impedance tomography"|One continous electrical impedance tomography (EIT) measurement per subject of approximately 5 minutes duration (2 min prior to MDCT scanning, during end-inspiratory MDCT acquisition and 2 min after MDCT scanning)
16015160|NCT02773654|Other|Healthy Volunteers|Scapula static position of subjects with and without shoulder symptoms will be recorded utilizing a mobile phone application placed on their scapula by either the examiner's hands or with a handle, held by the examiner.
16015161|NCT02773654|Other|Symptomatic Volunteers|Scapula static position of subjects with and without shoulder symptoms will be recorded utilizing a mobile phone application placed on their scapula by either the examiner's hands or with a handle, held by the examiner.
16015162|NCT02773641|Drug|Botulinum Toxin Type A|
16015163|NCT02773641|Drug|Sterile Saline Solution|
16015164|NCT02773628|Device|Acar'up system|
16015165|NCT02773628|Device|Acar'up placebo system|
16015166|NCT02773615|Procedure|Cardiac computed tomography|Non-invasive CT scan of the heart
16015167|NCT02773602|Drug|Dexamethasone|200 μgm/kg of dexamethasone in 1 ml saline
16015168|NCT02773602|Drug|Clonidine|2 μg/kg of clonidine in 1 ml saline
16015169|NCT02773602|Drug|Normal Saline|1 ml of saline added to the ropivacaine, 0.2%, 1 ml/kg
16015170|NCT02773589|Procedure|Peroral endoscopic myotomy|Peroral endoscopic myotomy
16015171|NCT02773576|Drug|Risperidone implant|
16015172|NCT02773563|Other|EUS with air insufflation|Diagnostic procedure using an echoendoscope for the study of pancreaticobiliary or gastrointestinal diseases using air insufflation
16015173|NCT02773563|Other|EUS with CO2 insufflation|Diagnostic procedure using an echoendoscope for the study of pancreaticobiliary or gastrointestinal diseases using CO2 insufflation
16015174|NCT02773550|Drug|Bortezomib|Low dose of bortezomib
16015175|NCT02773550|Drug|Melphalan|
16015176|NCT02773550|Drug|Prednisone|
16015177|NCT02773537|Drug|Femoral nerve catheter and sciatic nerve block|This nerve block is believed to cause both muscle weakness and numbness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes both the front and the back of the knee to be numb.
16015178|NCT02773537|Drug|Adductor canal catheter and selective tibial block|This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it to control pain. This technique causes both the front and the back of the knee to be numb.
16015179|NCT02773537|Drug|Adductor canal catheter only|This nerve block is believed to cause numbness only, without any muscle weakness. A catheter remains in place for up to 36 hours after surgery for the purpose of adding additional medication should the patient require it. This technique causes only the front of the knee to be numb
16015180|NCT02773524|Drug|Regorafenib|Regorafenib is the experimental intervention in this study. Regorafenib will be self-administered by participants at 160mg (4 x 40mg tablets) orally once daily on days 1-21 of each 28 day cycle plus best supportive care until progression or prohibitive toxicity as defined by the protocol.
16015589|NCT02770664|Drug|LC28-0126 Dose B|LC28-0126 Dose B
16015181|NCT02773524|Other|Placebo|Placebo (matching in appearance to regorafenib) made of microcrystalline cellulose, will be self-administered by participants at 160mg (4 x 40mg tablets) orally once daily on days 1-21 of each 28 day cycle plus best supportive care until progression or prohibitive toxicity as defined by the protocol.
16015182|NCT02773511|Procedure|Surgical treatment|Closed reduction and Kirschner wire fixation
16015183|NCT02773498|Procedure|conventional TESE|usual procedure for sperm extraction
16015184|NCT02773498|Procedure|Micro TESE|procedure of extraction is performed under the operating microscope
16015185|NCT02773485|Radiation|High Dose Radiation|The aim will be to deliver 52.5-60 Gy/ 25 fractions to the gross disease and 45 Gy/ 25 fractions to suspected microscopic disease along with weekly gemcitabine (300 mg/ m2) .
16015186|NCT02773485|Drug|Systemic chemotherapy|This arm will receive maximum 8 cycles of gemcitabine 1000 mg/m2 and cisplatin 25 mg/m2 delivered on day 1 and 8 every 3 weekly.
16015187|NCT02773472|Device|electroacupuncture|The acupoints that will be stimulated are: daheng, tianshu, zhongwan, xiawan, qihai, guanuian, hegu, guchi, zusanli, sanyinjiao, gongsun. An alternating fast-slow frequency of 20Hz/6Hz will be used with an interval of 250msec. The intensity (mA) will be adjusted to a level tolerated by each individual patient.
16015188|NCT02773472|Drug|morphine|Patient will not receive electroacupuncture. Patient will use morphine for analgesia.
16015189|NCT02773459|Drug|MEK162+capecitabine|In phase 1 part: capecitabine(mg/m2) will be given twice a day, 2 week on/1week off Q 3weeks + MEK162 twice a day, continuously, starting at 1000mg/m2 and 30mg/m2 respectively. Expansion part will be treated with the dose found at phase 1 part.
16015190|NCT02773446|Biological|ETEC strain B7A (O148:H28 CS6+ LT+ST+) (Lot 0481) in Buffer|ETEC Bacteria
16015191|NCT02773433|Other|Proportional Assist Ventilation|
16015192|NCT02773420|Procedure|HET Application|The HET device is a modified anoscope equipped with LED lighting, a tissue clamping mechanism and a bipolar energy source used to treat multiple hemorrhoidal columns in one sitting. Three columns of hemorrhoids were treated with 2 heat energy applications per column
16015193|NCT02773407|Drug|Azithromycin|
16015194|NCT02773407|Drug|Co-trimoxazole|
16015195|NCT02773381|Drug|semaglutide|Oral administration once-daily.
16015196|NCT02773381|Drug|placebo|Oral administration once-daily.
16015197|NCT02773368|Drug|insulin degludec/liraglutide|IDegLira will be given subcutaneously ( s.c., under the skin) once daily.
16015198|NCT02773368|Drug|insulin glargine|IGlar will be given subcutaneously ( s.c., under the skin) once daily.
16015199|NCT02773355|Drug|liraglutide 3.0 mg|Patients will be treated with commercially available Saxenda® prescribed according to routine clinical practice at the discretion of the treating physician.
16015200|NCT02773329|Other|sensor-based interactive exercise (game-based exercise)|This intervention includes interactive game-based balance training including repetitive weight shifting and virtual obstacle crossing tasks. Wearable sensors will provide real-time visual/auditory feedback from foot and ankle position and allowed perception of motor-errors during each motor-action.
16015201|NCT02773329|Other|Intervention without game-based exercise|Subjects are asked to perform non-technology based foot and ankle exercises, which include body weight shifting and obstacle crossing tasks.
16015202|NCT02773316|Drug|MR902|
16015203|NCT02773316|Drug|IR morphine sulphate|
16015204|NCT02773303|Device|Mente Autism™|A portable headband records EEG activity, and specialized algorithms convert the EEG activity into sonified binaural signals feeding them back to the user
16015205|NCT02773303|Device|Sham|a device externally identical to Mente Autism™, providing binaural beats but not tailor-made neurofeedback binaural beats
16015206|NCT02773290|Biological|Romiplostim|Weekly SC administration
16015207|NCT02773277|Other|head-impulse testing|all patients will receive quantitative head impulse testing using video goggles for all six semicircular canals.
16015208|NCT02773264|Device|Ultrasound|Ultrasound Elastography of soft tissue and organ lesions
16015209|NCT02773251|Drug|hyaluronic acid-carboxymethylcellulose|
16015210|NCT02773238|Procedure|Computed Tomography|Undergo FDG PET/CT
16015211|NCT02773238|Procedure|Computed Tomography|Undergo Tc-99m MAA or Tc-99m DTPA
16015212|NCT02773238|Radiation|Fludeoxyglucose F-18|Undergo FDG PET/CT
16015213|NCT02773238|Other|Laboratory Biomarker Analysis|Correlative studies
16015214|NCT02773238|Procedure|Positron Emission Tomography|Undergo FDG PET/CT
16015215|NCT02773238|Radiation|Radiation Therapy|Undergo functional avoidance radiation therapy
16015216|NCT02773238|Procedure|Single Photon Emission Computed Tomography|Undergo Tc-99m MAA or Tc-99m Undergo Tc-99m sulfur colloid SPECT/CT
16015217|NCT02773238|Radiation|Technetium Tc-99m Albumin Aggregated|Undergo Tc-99m MAA SPECT/CT
16015218|NCT02773238|Radiation|Technetium Tc-99m Sulfur Colloid|Undergo Tc-99m sulfur colloid
16015219|NCT02773225|Drug|Eltrombopag|"CSA + Eltrombopag, evaluation after three month therapy start regarding dose escalation
~6 month after therapy start --> evaluation and report of remission status of the study office --> unblinding by study office --> partial or complete remission Eltrombopag and slow tapering of CSA
~12 month after therapy start --> evaluation and report of remission status --> complete and partial remission --> tapering/end of study treatment"
16015220|NCT02773225|Drug|Placebo (for Eltrombopag)|"CSA + Placebo, evaluation after three month therapy start regarding dose escalation
~6 month after therapy start --> evaluation and report of remission status of the study office --> unblinding by study office --> no complete remission: CSA + Eltrombopag and evaluation 3 months after therapy start --> dose escalation
~12 month after start of eltrombopag --> evaluation and report of remission status --> complete and partial remission --> tapering/end of study treatment"
16015221|NCT02773212|Drug|d-amphetamine|Participants in this group will receive 60 mg of d-amphetamine daily for 4 weeks. There will be a 1 week run up dosing and a 1 week run-down medication period.
16015222|NCT02773212|Behavioral|Contingency management|Contingency management is an established cocaine use disorder treatment in which individuals receive monetary rewards for abstinence.
16015223|NCT02773212|Drug|Placebo (for d-amphetamine)|60 mg of riboflavin and cornstarch as needed.
16015224|NCT02773199|Other|Preoperative Fasting for 8 hours|Patients will be exposed to preoperative fasting
16015225|NCT02773199|Other|Preoperative Fasting for more than 12 hours|Patients will be exposed to preoperative fasting
16015227|NCT02773186|Other|monitoring cerebral oxygen saturation|Children undergoing urological surgery also required of locoregional blockade. Anesthetic induction was achieved with high concentration sevoflurane 6-8% (Sevorane®, Abbvie) and oxygen 50%. Anesthetic maintenance was done with sevoflurane 2-3%, 50% O2/air mixture, fentanyl 1 µg.kg.-1 iv, and rocuronium 0.3 µg.kg.-1 iv if required. Electrocardiogram (ECG), non-invasive arterial pressure, pulse oximetry, end-tidal carbon dioxide and cerebral NIRS oximetry was monitoring by using an INVOSTM5100 (Somanetics Corporation, Troy, MI, USA).
16015228|NCT02773173|Procedure|IPP in colorectal laparoscopic surgery|Deep neuromuscular blockade can only be reversed with sugammadex, so in the IPP group, it will be used as neuromuscular blocking agent and its effect will be reversed with sugammadex (4mg / kg) at the end of the surgery. During surgery: deep neuromuscular blockade (PTC 1-5), Protective ventilation strategy, Optimal position and Pre stretching as a tool to decrease intraabdominal pressure maintaining optimal workspace.
16015229|NCT02773173|Procedure|SPP in colorectal laparoscopic surgery|A depolarizing neuromuscular blocking will be used (as routine clinical practice at each center) to maintain moderate neuromuscular blockade and its effect will be reversed with anticholinesterase at the end of the surgery. During surgery: Moderate neuromuscular blockade ( TOF 2-4) , position to surgeon criteria, no prestretching and Protective ventilation. Fixed IAP (12mmHg).
16015230|NCT02773160|Other|Sensor-based postural feedback|Motion tracking sensors will provide feedback to subjects during the learning phase of a motor control task
16015231|NCT02773160|Other|Mirror feedback|Subjects will receive feedback from a mirror during the learning phase of a motor control task
16015232|NCT02773160|Other|Control group|Subjects will receive no feedback during the learning phase of a motor control task
16015233|NCT02773147|Drug|Cyanocobalamin|
16015234|NCT02773147|Drug|Folate|
16015235|NCT02773147|Drug|Pyridoxine|
16015236|NCT02773134|Other|Brace Group|"All eligible patients will undergo a Posterior Spine Instrumented Fusion (PSIF) with the use of autologous local and iliac crest bone graft, and all pedicle screw instrumentation. A deep wound drain will be placed in all patients for 48 hours.
~All patients will complete the Oswestry Disability Index (ODI) questionnaire, the SF-12v2 General Health Survey and the Visual Analogue Scale (VAS) for back pain at baseline visit (preoperatively) and post-operatively at 6 weeks and 3 months follow up. Clinical and radiographic assessments will be performed by independent blinded observers not involved in patient care."
16015237|NCT02773134|Other|Control Group|"All eligible patients will undergo a Posterior Spine Instrumented Fusion (PSIF) with the use of autologous local and iliac crest bone graft, and all pedicle screw instrumentation. A deep wound drain will be placed in all patients for 48 hours.
~Bracing will not be prescribed postoperatively for this group. All patients will the Oswestry Disability Index (ODI) questionnaire, the SF-12v2 General Health Survey and the Visual Analogue Scale (VAS) for back pain at baseline visit (pre-operatively) and post-operatively at 6 weeks and 3 months follow up. Clinical and radiographic assessments will be performed by independent blinded observers not involved in patient care."
16015238|NCT02773121|Behavioral|Physical Activity|Trainer-guided at-home behavioral intervention
16015239|NCT02773095|Other|Novartis Access|Eight counties will be matched in pairs and randomized within each pair to either receive Novartis Access portfolio low-cost medications or to remain a control county.
16015240|NCT02773082|Device|Reclaim™ DBS Therapy|The Medtronic Reclaim DBS Therapy is indicated for bilateral stimulation of the anterior limb of the internal capsule, AIC, as an adjunct to medications and as an alternative to anterior capsulotomy for treatment of chronic, severe, treatment-resistant obsessive compulsive disorder (OCD) in adult patients who have failed at least three selective serotonin reuptake inhibitors (SSRIs). Medtronic received humanitarian device exemption (HDE) approval for Reclaim DBS Therapy for the management of OCD on February 19, 2009.
16015241|NCT02773069|Behavioral|Church Bridge Project|Community-based participatory research combining efforts of academic researchers, church leaders, primary care providers and community stakeholders.
16015242|NCT02773056|Device|Ischial Ramus Containment (IRC)|Ischial Ramus Containment (IRC) is the standard of care socket
16015243|NCT02773056|Device|Dynamic Socket Ischial Ramus Containment (IRC)|Dynamic Socket Ischial Ramus Containment (IRC) is a comparator study socket
16015244|NCT02773056|Device|Sub-Ischial Interface (Sub-I)|Sub-Ischial Interface (Sub-I) is a comparator study socket
16015245|NCT02773043|Device|CZT SPECT camera|
16015246|NCT02773030|Drug|CC-220|CC-220 at dose specified by cohort dose level from Day 1-21 of each 28-day cycle.
16015247|NCT02773030|Drug|Dexamethasone|Oral DEX 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle. For subjects >75 years old, oral DEX will be administered at 20 mg on Days 1, 8, 15, and 22 of each 28-day cycle.
16015248|NCT02773030|Drug|Daratumumab - 16mg/kg|Daratumumab (DARA) 16mg/kg by intravenous infusion on Days 1, 8, 15, and 22 at cycle 1-2, Days 1, 15 at cycle 3-6, and Day 1 at cycle ≥7 of each 28-day cycle.
16015249|NCT02773030|Drug|Bortezomib (BTZ)|Bortezomib 1.3 mg/m^2 on Days 1, 4, 8 and 11 at cycle 1-8, and Days 1, 8 at cycle ≥9 of each 21-day cycle.
16015250|NCT02773030|Drug|Carfilzomib|Intravenous (IV) CFZ administered at a starting dose of 20 mg/m2 on C1D1 and C1D2; and at a dose level specified by cohort dose level thereafter Days 1, 2, 8, 9, 15, 16 of each 28-day cycle.
16015251|NCT02773030|Drug|Daratumumab- 1800mg|Daratumumab (DARA) 1800 mg by subcutaneous injection on Days 1, 8, 15, and 22 at cycle 1-2, Days 1, 15 at cycle 3-6, and Day 1 at cycle ≥7 of each 28-day cycle.
16015252|NCT02773017|Drug|Dexmedetomidine A|initial dose was 1.0 μg/kg dexmedetomidine, with dose adjustment intervals of 0.1μg/kg in first three turning points and 0.05μg/kg in the last three turning points.
16015253|NCT02773017|Drug|Dexmedetomidine B|initial dose was 1.0 μg/kg dexmedetomidine, with dose adjustment intervals of 0.1μg/kg in first three turning points and 0.05μg/kg in the last three turning points.
16015254|NCT02773017|Drug|Dexmedetomidine C|initial dose was 1.0 μg/kg dexmedetomidine, with dose adjustment intervals of 0.1μg/kg in first three turning points and 0.05μg/kg in the last three turning points.
16015255|NCT02773004|Other|EPClin genomic test|
16015256|NCT02772991|Other|troponin measurement|Cardiac catheterization (for patients with >50% lesions) or discharge or in patients with intermediate risk.
16015257|NCT02772978|Drug|Tolcapone|Tolcapone is in the medication class of catechol-O-methyltransferase (COMT) inhibitors
16015258|NCT02772978|Drug|Placebo|A placebo is a tablet or capsule that looks like the study medication (in this case, tolcapone) but does not contain any active ingredients
16015259|NCT02772965|Drug|Methotrexate|"Oral methotrexate (MTX): The weekly dose will be 15 mg for children ≥ 40kg, 12.5 mg for children 30 to <40 kg, and 10 mg for children 20 to <30 kg.
~A twice per week, 4mg dose of ondansetron will be provided as pre-treatment to prevent nausea (study provider may opt-out of this component based on clinical judgement).
~A 1 mg dose of folic acid per day will be provided. This will help to reduce the risk of side effects in the MTX group.
~Drug kits will contain a 3 month supply of each medication. Refills will be provided every 3 months until week 156 unless there is a failure to induce and maintain remission, development of unacceptable toxicity, pregnancy in a female participant, or failure of the participant to attend scheduled study visits."
16015260|NCT02772965|Other|Sugar pill (placebo)|"Placebo for methotrexate: The weekly dose will mimic that of methotrexate.
~Placebo for ondansetron: The weekly dose will mimic that of ondansetron (study provider may opt-out of this component based on clinical judgement).
~A 1 mg dose of folic acid per day will be provided to maintain blinding.
~Drug kits will contain a 3 month supply of each medication. Refills will be provided every 3 months until week 156 unless there is a failure to induce and maintain remission, development of unacceptable toxicity, pregnancy in a female participant, or failure of the participant to attend scheduled study visits."
16015261|NCT02772952|Other|Control Intervention|Control Intervention: review medication + adequacy of diet + health education (physical activity recommendation (within a comprehensive advice on healthy lifestyles)
16015262|NCT02772952|Other|Multimodal Intervention|Multimodal Intervention: therapeutic exercise + review medication + adequacy of diet + health education program
16015263|NCT02772939|Device|Renal sympathetic denervation (RDN)|Catheter based renal sympathetic denervation for therapy resistant arterial hypertension
16015264|NCT02772926|Dietary Supplement|Benfotiamine|Benfotiamine (S-Benzoylthiamine O-monophosphate) 900 mg per day
16015265|NCT02772926|Dietary Supplement|Placebo|Placebo 900 mg per day
16015266|NCT02772900|Other|Beetroot-based nutritional gel|100 g of beetroot-based nutritional gel containing approximately 12 mmol of nitrate.
16015267|NCT02772900|Other|Placebo|100 g of apple-based nutritional gel containing approximately 0.02 mmol of nitrate.
16015268|NCT02772887|Dietary Supplement|L-Citrulline|amino acid supplement
16015269|NCT02772887|Other|Placebo|placebo
16015270|NCT02772874|Other|No intervention|No intervention
16015271|NCT02772861|Dietary Supplement|Amino Acid Supplement - One dose|20gr
16015272|NCT02772861|Dietary Supplement|3-Methylhistidine|120mgr
16015273|NCT02772835|Device|Medin-cno|Medin-cno is a noninvasive ventilator. With this device we can practice either nCPAP and nHFOV ventilation.
16015274|NCT02772822|Drug|SCT400 plus CHOP|
16015275|NCT02772822|Drug|Rituximab plus CHOP|
16015276|NCT02772809|Device|Haptic Robot Therapy with Games|Commercial Joystick and Wheels Plus the Haptic TheraDrive Robot will be used. Haptic Theradrive is a low-cost robotic system for post-stroke upper extremity rehabilitation. The system uses off-the-shelf computer gaming wheels with force feedback to help reduce motor impairment and improve function in the arms of stroke survivors.
16015277|NCT02772796|Drug|SENS-218|Oral Administration
16015278|NCT02772783|Other|high GI meal|High and low GI liquid test meals are matched for macronutrient composition (60% carbohydrate, 15% protein, 25% fat), micronutrient profiles, physical properties, palatability and sweetness. Meals will provide 25% of individual daily energy requirements as estimated by the Harris Benedict equation. A high glycemic index of ~90 is achieved by using corn syrup as a carbohydrate source.
16015279|NCT02772783|Other|low GI meal|High and low GI liquid test meals are matched for macronutrient composition (60% carbohydrate, 15% protein, 25% fat), micronutrient profiles, physical properties, palatability and sweetness. Meals will provide 25% of individual daily energy requirements as estimated by the Harris Benedict equation. A low glycemic index of ~40 is achieved by using uncooked corn starch as a carbohydrate source.
16015280|NCT02772783|Drug|euglycemic insulin clamp|Insulin will be given intravenously for 5 hours. During the entire clamp protocol, glucose levels will be measured every 5 minutes. A basal insulin infusion will be started at 80% of the patients insulin pump basal rate, and will be adjusted between 0.1 and 2.5 mU/kg•min, depending upon the patient's plasma glucose level in relation to the target range target of 90-100 mg/dl.
16015281|NCT02772783|Drug|primed-variable insulin infusion|A primed-variable infusion of insulin will be administered at the rate established to achieve euglycemia after a low glycemic index meal. This is expected to result in moderate hyperglycemia as the high GI meal is associated with higher insulin requirements. For patient safety, glucose levels will be measured every 30 minutes. If glucose levels are > 400 mg/dl or < 60 mg/dl, insulin infusion will be adjusted to maintain glucose levels target of 60-400 mg/dl.
16015282|NCT02772770|Other|Non-operative treatment group will undergo standardized treatment which will include rehabilitation, bracing and certain activity restrictions|The non-operative treatment group will undergo standardized treatment which will include rehabilitation, bracing and certain activity restrictions.
16015283|NCT02772770|Procedure|Surgical technique: Transphyseal reconstruction|Study physicians will have the option to treat ACL injuries operatively or non-operatively, according to their standard of care. However, once the decision is made to manage the injury operatively or non-operatively, the physician must follow the appropriate standardized treatment protocol developed for the study. The operative treatment protocol will include standardized surgical techniques for transphyseal reconstruction with soft tissue graft and metaphyseal fixation.
16015284|NCT02772770|Procedure|Surgical technique: Partial transphyseal reconstruction|Study physicians will have the option to treat ACL injuries operatively or non-operatively, according to their standard of care. However, once the decision is made to manage the injury operatively or non-operatively, the physician must follow the appropriate standardized treatment protocol developed for the study. The operative treatment protocol will include partial transphyseal reconstruction (tibial transphyseal and femoral epiphyseal) with soft tissue graft.
16015285|NCT02772770|Procedure|Surgical technique: Physeal sparing reconstruction by the Anderson method|Study physicians will have the option to treat ACL injuries operatively or non-operatively, according to their standard of care. However, once the decision is made to manage the injury operatively or non-operatively, the physician must follow the appropriate standardized treatment protocol developed for the study. The operative treatment protocol will include standardized surgical techniques for physeal sparing epiphyseal reconstruction with soft tissue graft (Anderson technique).
16015590|NCT02770664|Drug|LC28-0126 Dose C|LC28-0126 Dose C
16015286|NCT02772770|Procedure|Surgical technique: Physeal sparing reconstruction by the Micheli/Kocher method|Study physicians will have the option to treat ACL injuries operatively or non-operatively, according to their standard of care. However, once the decision is made to manage the injury operatively or non-operatively, the physician must follow the appropriate standardized treatment protocol developed for the study. The operative treatment protocol will include physeal-sparing with Iliotibial band combined extra-articular and intra-articular reconstructions (Micheli/Kocher Technique).
16015287|NCT02772757|Behavioral|standard hearing aid fitting|standard hearing aid, face-to-face fitting
16015288|NCT02772757|Behavioral|coupler-based fitting|coupler-based fitting using average RECDs
16015289|NCT02772757|Behavioral|coupler-based fitting|coupler-based fitting using measured RECDs
16015290|NCT02772744|Drug|Daclatasvir 60 MG Oral Tablet [Daklinza]|Daclatasvir (60 MG) is a potent, pan-genotypic inhibitor of the HCV NS5A protein
16015291|NCT02772744|Drug|Sofosbuvir 400 MG Oral Tablet [Sovaldi]|Sofosbuvir (400 MG) is a nucleotide analogue HCV NS5B polymerase inhibitor
16015292|NCT02772744|Drug|Ribavirin Oral Product|Ribavirin (twice-daily) dosed according to body weight (<75 kg, 1000 mg daily; ≥75 kg, 1200 mg daily)
16015293|NCT02772731|Procedure|Partial mastectomy plus additional Shave Margin|"For the shave group, additional superior, inferior, medial and lateral margins will be removed, oriented, and sent for pathologic evaluation at the local site. Resection of additional anterior and posterior margins will be left to surgeon discretion, as this will depend on if skin or fascia was taken. All surgeons participating in the study will be educated on the expectation of what is considered a shave margin. A shave margin is defined as an additional segment of breast tissue taken from each of the superior, inferior, medial, and lateral aspects of the cavity, such that the entire circumference of the cavity is re-excised following this procedure. Orientation of each shaved margin will be done to mark the true margin."
16015294|NCT02772731|Procedure|Partial mastectomy|Surgeons will be instructed to close after partial mastectomy with no further excision.
16015295|NCT02772718|Drug|XOMA 358 single dose level A|XOMA 358 single dose level A administered by intravenous infusion
16015296|NCT02772718|Drug|XOMA 358 single dose level B|XOMA 358 single dose level B administered by an intravenous infusion
16015297|NCT02772718|Drug|XOMA 358 single dose level C|XOMA 358 single dose level C administered by an intravenous infusion
16015298|NCT02772718|Drug|XOMA 358 multiple dose level 1|XOMA 358 multiple dose level 1 administered by an intravenous infusion
16015299|NCT02772692|Behavioral|Squatting pan|Using squatting pans to replace standard-sized toilets in one group of the included constipation patients
16015301|NCT02772666|Device|O-Glass|The new diagnostic device to distinguish relative afferent pupillary defect(RAPD).
16015302|NCT02772666|Other|Swinging Flashlight Test|The swinging-flashlight test is used to help a practitioner identify a relative afferent pupillary defect.For an adequate test, vision must not be entirely lost. In dim room light, the examiner notes the size of the pupils. The patient is asked to gaze into the distance, and the examiner swings the beam of a penlight back and forth from one pupil to the other, and observes the size of pupils and reaction in the eye that is lit.
16015303|NCT02772653|Other|Blood Lactate|Analyzed at the 1rst, 8th and 24th hour from hospital admission
16015304|NCT02772653|Other|Blood Base Excess|Analyzed at the 1rst, 8th and 24th hour from hospital admission
16015305|NCT02772653|Other|Blood B-type Natriuretic Peptide|Analyzed at the 1rst, 8th and 24th hour from hospital admission
16015306|NCT02772653|Other|Blood Thromboelastometry (ROTEM)|Analyzed at the 1rst, 8th and 24th hour from hospital admission
16015307|NCT02772653|Other|Near-infrared spectroscopy|Analyzed at the 1rst, 8th and 24th hour from hospital admission
16015308|NCT02772653|Other|Sublingual videomicroscopy|Analyzed at the 1rst, 8th and 24th hour from hospital admission
16015309|NCT02772640|Drug|Rosuvastatin and Ezetimibe morning or evening administration|"Timing of the drug administration:
~morning -> evening evening -> morning"
16015310|NCT02772627|Drug|Nebicapone|Nebicapone 100 mg tablets; oral route.
16015311|NCT02772627|Drug|Placebo|Placebo tablets; oral route.
16015312|NCT02772614|Drug|BIA 3-202 (200 mg)|200 mg powder for oral use of unlabelled BIA 3-202
16015313|NCT02772601|Drug|Caffeine|
16015314|NCT02772601|Drug|Warfarin|
16015315|NCT02772601|Drug|Omeprazole|
16015316|NCT02772601|Drug|Metoprolol|
16015317|NCT02772601|Drug|Midazolam|
16015318|NCT02772601|Drug|Risankizumab|
16015319|NCT02772588|Drug|ARN-509|
16015320|NCT02772588|Drug|Abiraterone|
16015321|NCT02772588|Drug|Leuprolide|
16015322|NCT02772588|Radiation|stereotactic, ultra-fractionated radiotherapy|
16015323|NCT02772575|Procedure|Hepatic trans-arterial embolization (TAE)|
16015324|NCT02772575|Device|MRI/CT scan|
16015325|NCT02772575|Procedure|biopsy|
16015326|NCT02772575|Other|blood draw|
16015327|NCT02772562|Biological|PROSTVAC-V/F|"0.5 ml containing at least 2 x 108 Infectious Units (Inf.U) PROSTVAC-V given on day 1.
~0.5 ml containing at least 1 x 109 Inf.U PROSTVAC-F given on days 15, 28, 57, 85, 113, 141."
16015328|NCT02772536|Other|Visual Stimulus Condition Set|"In this single arm study, all participants are subject to a set of three visual stimulus conditions.
~Low ambient light for 10 mins: Self selected tinted light (20 Mins); White light (20 mins).
~VAS/CGI scores for each stimulus condition in the above set are reported at five minute intervals."
16015329|NCT02772523|Other|Lifestyle recommendations|Dietary, and physical, cognitive and social activity recommendations
16015330|NCT02772510|Device|Smart glove system with functional electrical stimulation|Game-based virtual reality rehabilitation system (Smart glove system) combined with functional electrical stimulation on distal upper extremity
16015331|NCT02772510|Device|Functional electrical stimulation|Functional electrical stimulation on distal upper extremity
16086299|NCT02262598|Drug|Telmisartan|
16015332|NCT02772497|Drug|Ziv aflibercept|Intravitreal ziv aflibercept 1.25 mg (0,05ml) every 4 weeks
16015333|NCT02772484|Device|HS-1000|
16015334|NCT02772471|Device|HS-1000|
16015335|NCT02772458|Other|Dodecanoate acid and saline|Test drink
16015336|NCT02772445|Behavioral|STROKE-CARE|In STROKE-CARE, caregivers will learn a problem-solving strategy. They will (1) identify barriers to performance, (2) generate strategies to address barriers, and (3) apply these strategies to support care-recipients in occupations.
16015337|NCT02772432|Behavioral|Relaxation Response Resiliency Training for Parents of SPLD|
16015338|NCT02772419|Drug|benralizumab|SC administration
16015339|NCT02772419|Drug|benralizumab|SC administration
16015340|NCT02772419|Drug|Placebo|SC administration
16015341|NCT02772406|Device|Linked Color Imaging|
16015342|NCT02772406|Device|white light imaging|
16015343|NCT02772380|Device|Defibrillation following induction of VT/VF|Up to 10 attempts to induce two VF/VT episodes for defibrillation testing
16015344|NCT02772367|Procedure|skin punch biopsy|
16015345|NCT02772354|Procedure|Radiofrequency catheter ablation|Biosense Webster: NAVI-STAR ThermoCool, NAVI-STAR® RMT ThermoCool
16015346|NCT02772354|Drug|Metoprolol|"Antiarrhythmic therapy of premature ventricular complexes
~Metoprolol 12-50 mg"
16015347|NCT02772354|Drug|Verapamil|Verapamil 20-240 mg
16015348|NCT02772354|Device|NAVI-STAR® RMT ThermoCool|
16015349|NCT02772341|Device|Salt room with halogenerator|Patients were assigned to 14 sessions (7 weeks, twice weekly, 45 minutes each treatment) sitting in a salt room with salt aerosol produced by a halogenerator (study group) or halotherapy without salt aerosol (placebo). Both the walls and the ceiling of the salt room are completely covered with ESCO-(European Salt Company) type certified-origin rock salt. The temperature (20-24°C) and humidity (44-60%) are at constant values. The halogenerator is located outside the salt room.
16015350|NCT02772341|Other|Salt room without halogenerator|Patients were assigned to 14 sessions (7 weeks, twice weekly, 45 minutes each treatment) sitting in a salt room without salt aerosol (placebo). Both the walls and the ceiling of the salt room are completely covered with ESCO-(European Salt Company) type certified-origin rock salt. The temperature (20-24°C) and humidity (44-60%) are at constant values.
16015351|NCT02772328|Behavioral|Peer Mentor|comparison of communication training to equal attention control
16015352|NCT02772315|Other|omics|diagnostic procedures applying omics results
16015353|NCT02772302|Device|mindBEAGLE EEG-based brain-computer interface|
16015354|NCT02772289|Biological|Mesenchyme Stem Cells low-dose group|Participants will receive transdermal one dose of 1*10^6 cells of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous three days and then receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous next three days.
16015355|NCT02772289|Biological|Mesenchyme Stem Cells high-dose group|Participants will receive transdermal one dose of 1*10^6 cells of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days.
16015356|NCT02772289|Biological|Placebo|Participants will receive transdermal placebo without of Perinatal Tissue Mesenchyme Stem Cells in the gel once a day for continuous six days.
16015357|NCT02772276|Drug|MB-102-- single dose|4 µmol/kg administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds.
16015358|NCT02772276|Drug|MB-102-- two doses|4 µmol/kg administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds. A subset of participants will receive two doses of MB-102, 12 hours apart.
16015359|NCT02772276|Drug|Iohexol|5 mL of a 647 mg/mL solution administered by intravenous injection over 30 seconds, followed by a 10 mL normal saline flush administered intravenously over 30 seconds
16015360|NCT02772276|Device|QuantumLeap|Optical Renal Function Monitor (ORFM)
16015361|NCT02772276|Device|Radiance|Optical Renal Function Monitor (ORFM)
16015362|NCT02772276|Device|Brilliance|Optical Renal Function Monitor (ORFM)
16015363|NCT02772263|Other|CHAP-EMS|The CHAP-EMS program is a low cost community program that is designed to assess community dwelling seniors for lifestyle risk factors that may impact their health and well-being and to provide targeted education to address the pertinent risk factors. Each participant is guided through a structured health-risk assessment focused on diabetes, cardiovascular disease and other potential health issues. The assessment is conducted by a trained paramedic in a common area within the community housing building. Data gathered are used to develop individualized action plans concerning health-risk reduction, to direct participants to local health activities or resources, educate on promoting health and to transmit this information to a participants' family physician.
16015364|NCT02772250|Behavioral|telephone re-education(TRE)|Subjects who are randomized into this group receive regular instructions at the time of their appointment to discuss colonoscopy (a nurse provides education of 5 minutes and meanwhilet sent a bookle to the patient) and a TRE which was conducted by one investigator at 15:00-17:00 on the day before colonoscopy.
16015365|NCT02772250|Behavioral|face-to-face re-education (FFRE)|Subjects who are randomized into this group receive regular instructions on the day of their appointment to discuss colonoscopy and also a FFRE which was conducted by a investigator on the same-day of procedure at hospital.
16015366|NCT02772237|Biological|Riboflavin|Riboflavin 400mg daily
16015367|NCT02772237|Biological|Placebo|
16015368|NCT02772224|Device|Drug eluting balloon angioplasty|In the DEB group, the guide wire will be passed through the occluded or stenosed lumen and the predilatation of the target lesion with standard balloon(s) will be performed before dilatation with a paclitaxel-eluting balloon of the diameter, at least about that of the pre-dilatation balloon (Arteryguard, Rientech, Dezhou, China). The drug eluting balloons will then be inflated according to the manufacturer recommendations. The patients will then be followed every six months for a year to compare its treatment efficacy and safety with that of conventional balloon angioplasty group.
16015369|NCT02772224|Device|Conventional balloon angioplasty|The guide wire will be passed through the occluded or stenosed lumen and the conventional balloons will be inflated as recommended by the manufacturer. The primary and secondary outcome will then be assessed and compared with DEB group, on follow up at six and 12 months.
16015405|NCT02771990|Device|transcranial direct current stimulation|2 milliamp (mA) 20 minutes
16015706|NCT02769858|Device|Light therapy|Light therapy glasses
16015370|NCT02772211|Drug|Ketamine|"Patients will undergo 6 ketamine infusions within a 3-week period. Intravenous ketamine will be administrated by a senior anesthesiologist and under the supervision of a senior psychiatrist hence ensuring patient safety. The procedure will be explained in detail to each patient, and written consent will be obtained.
~After a psychiatric and medical evaluation by a senior psychiatrist and a senior anesthesiologist, patients will be given ketamine infusion added on to their antidepressant therapy. A slow ketamine infusion of 0.5mg/kg over 40 minutes will be given to the patients. Patients will be monitored by the experienced staff which includes a senior anesthesiologist and a nurse as well as a psychiatrist who will be available nearby. All patients will be monitored continuously for heart rate and rhythm and oxygen saturation, and blood pressure will be measured at 10 minutes intervals."
16015371|NCT02772211|Drug|D-cycloserine|"Following completion of Ketamine infusions. patients in the experimental group will start receiving D-cycloserine pills titrated slowly up to 1000mg/d over the next 8 weeks [2] in the following manner:
~Week 4: Days 22-24 - 250mg/d, one pill per day Well-being assessment and adverse effect evaluation before drug elevation.
~Mid-week 4 to end of week 6: Days 25-42 - 500mg/d, two pills per day
~Week 7: Day 43-49 - 750mg/d, three pills per day
~Weeks 8-11: Days 50-77 - 1000mg/d four pills per day"
16015372|NCT02772211|Drug|Placebo|"Following completion of Ketamine infusions. patients in the experimental group will start receiving placebo titrated slowly up to 1000mg/d over the next 8 weeks [2] in the following manner:
~Week 4: Days 22-24 - 250mg/d, one pill per day Well-being assessment and adverse effect evaluation before drug elevation.
~Mid-week 4 to end of week 6: Days 25-42 - 500mg/d, two pills per day
~Week 7: Day 43-49 - 750mg/d, three pills per day
~Weeks 8-11: Days 50-77 - 1000mg/d four pills per day"
16015373|NCT02772198|Biological|CD19 CAR T cells|Autologous T cells activated and transduced with a chimeric antigen receptor targeting CD19
16015374|NCT02772185|Device|active tDCS|Duration: 30 minutes; Intensity: 2 mA; Placement:left and right parietal cortex, left and right DLPFC, left inferior frontal gyrus and left superior temporal gyrus
16015375|NCT02772185|Device|sham tDCS|The procedure is the same as for active tDCS, but the in the placebo tDCS the stimulation is non-active / sham.
16015376|NCT02772185|Behavioral|real CT|Cognitive tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left inferior frontal gyrus and left superior temporal gyrus).
16015377|NCT02772185|Behavioral|placebo CT|Videos (short films) will be presented during the neurostimulation
16015378|NCT02772172|Device|Surgical Template|
16015379|NCT02772159|Drug|TD-4208|One dose each of treatments A: [14C] TD-4208 20 μg IV administered in a fasted state over 30 minutes. B: [14C] TD-4208 200 μg oral solution administered in a fasted state.
16015380|NCT02772146|Device|CLS UF|One single ultrafiltration session of 10 hours.
16015381|NCT02772133|Procedure|Primary PCI|
16015382|NCT02772120|Drug|Vaginal progesterone gel (Crinone® 8%)|Crinone® 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) is administered once 5 days prior to embryo transfer, then twice per day until the pregnancy test is negative or until the 10th week of pregnancy.
16015383|NCT02772120|Drug|Intramuscular Progesterone|Progesterone-25 mg intramuscularly once 5 days prior to embryo transfer, then 50 mg once per day until the pregnancy test is negative or until the 10th week of pregnancy.
16015384|NCT02772107|Drug|Temozolomide|Temozolomide is a nonclassic oral alkylating agent. Temozolomide will be given alone as maintenance therapy in patients who have achieved study entry hematologic criteria and who do not have progressive disease or severe toxicity. During temozolomide maintenance therapy, patients will receive temozolomide at 150mg/m2/d for 5 days of a 28-day cycle orally daily. Temozolomide maintenance therapy will continue until progressive disease or irreversible toxicity occurs.
16015385|NCT02772107|Drug|first-line chemotherapy|first-line chemotherapy must be platinum-based: cisplatin(75mg/m2 for d1) or carboplatin（AUC 5 for d1) combined with etoposide（100mg/m2 for d1-d3）
16015386|NCT02772107|Radiation|Prophylactic cranial irradiation|Prophylactic cranial irradiation was allowed if necessary
16015387|NCT02772107|Radiation|thoracic radiotherapy|thoracic radiotherapy was allowed if necessary
16015388|NCT02772094|Biological|Single arm, open-label|"Biological: ADCTA-G. Biological: autologous DC loaded with irradiated autologous tumor cells. Biological: dendritic cell vaccine. Drug: 180mg/m2•per day temozolomide prior and concomitant with radiotherapy. Radiotherapy: Local ionizing radiation 200 centigray(cGy)/day, 5 successive days per week for 6 weeks, total dose of 6000 cGy.
~Drug: Adjuvant chemotherapy-temozolomide (TMZ) monthly cycle, 200mg/m2•per day continued for 5 days in the beginning of every month, 6 cycles of TMZ."
16015389|NCT02772081|Combination Product|LISA combination product (Curosurf+catheter CHF6440)|Curosurf administration through brief insertion of a thin catheter into the trachea
16015390|NCT02772081|Drug|Curosurf through conventional administration (endotracheal tube)|Curosurf through conventional administration (endotracheal tube), followed by rapid extubation
16015391|NCT02772068|Drug|Istaroxime|Subjects will be given Istaroxime, a novel SERCA2a activator one hour prior and during exercise.
16015392|NCT02772068|Other|Exercise|
16015393|NCT02772055|Other|Moxibustion|Moxibustion at three acupuncture point(EX-LE04,ST35,ST36).12 sessions of moxibustion treatment over a period of 4 weeks, 3 sessions per week.Each session will last 30 minutes.
16015394|NCT02772055|Other|Moxa smoke purification device|Investigators place a purification device(Shenzhen Conyson Electronic Technology Co, Ltd,C200 moxa smoke purification device,Shenzhen,China) at the top of the moxibustion to remove the moxa smoke.
16015395|NCT02772042|Other|Intervention Group|
16015396|NCT02772042|Other|Control Group|
16015397|NCT02772029|Drug|Apatinib Mesylate Tablets|Apatinib 750 mg is administered orally daily, until disease progression or untolerable toxicity.
16015398|NCT02772016|Drug|Colla corii asini|15 g of Colla corii asini in powder form daily for 4 weeks
16015399|NCT02772003|Biological|Electroporation-Mediated Plasmid DNA Vaccine Therapy|Undergo electroporation
16015400|NCT02772003|Biological|HCV DNA Vaccine INO-8000|Given IM
16015401|NCT02772003|Other|Laboratory Biomarker Analysis|Correlative studies
16015402|NCT02772003|Other|Quality-of-Life Assessment|Ancillary studies
16015403|NCT02772003|Biological|Rocakinogene Sifuplasmid|Given IM
16015404|NCT02771990|Device|Sham transcranial direct current stimulation|sham stimulation
16086731|NCT02259803|Drug|Telmisartan|
16015406|NCT02771977|Other|Drug-specific alert|A drug-specific alert, informing the provider of the presence of AKI as well as recent exposure to a potentially nephrotoxic agent, will be fired.
16015407|NCT02771964|Other|Quality of life survey|"All enrolled patients complete a survey of baseline health during their visit to the preoperative assessment clinic and then complete a follow-up survey approximately 30 days after surgery.
~The intervention for this study is to compare self-reported quality of life (How would you rate your quality of life now? (better/same/worse)) to the quantitative change in their VR-12 quality of life scores between the baseline survey and 30-day follow-up survey."
16015408|NCT02771951|Behavioral|"Lights of Change"|
16015409|NCT02771951|Behavioral|Usual Care|
16015410|NCT02771938|Other|Radiotherapy before surgery|Radiotherapy followed by mastectomy and DIEP flap reconstruction
16015411|NCT02771938|Other|Radiotherapy after surgery|Mastectomy and DIEP flap reconstruction followed by radiotherapy
16015412|NCT02771925|Drug|Gabapentin 2g/day divided in two doses for 24 weeks|"Total subjects 100 (Alcoholic liver disease:Alcoholics with no liver disease= 1:1) each will receive Gabapentin 2000mg/day divided in two doses for 24 weeks.
~All patients will receive standard of care treatment."
16015413|NCT02771925|Drug|Placebo 2g/day divided in two doses for 24 weeks|Total subjects 100 (Alcoholic liver disease: Alcoholics with no liver disease= 1:1)) each will receive Placebo 2000mg/day divided in two doses for 24 weeks. All patients will receive standard of care treatment. Concurrent with study medication, study clinicians will provide participants with 20 minutes of weekly manual-guided counseling designed to increase motivation, abstinence, and medication compliance.
16015414|NCT02771912|Drug|Propofol|Propofol and excipients
16015415|NCT02771912|Drug|Placebo|Qualitative composition of Propofol lipuro 2% excipients
16015416|NCT02771899|Device|spineEOS software|During a full-length exam from head to feet in the standing position, 3D reconstructions of the spine, the pelvis and lower extremities using spine workflow and global postural assessment workflow on spineEOS software will be performed.
16015417|NCT02771899|Device|EOS|The system performs a full-length exam from head to feet in the standing position. 2D parameters will be obtained per standard of care.
16015418|NCT02771886|Behavioral|Surf the Urge|"The intervention teaches clients to be aware of and accept their feelings, thoughts, and sensations in a non-judgmental manner. Clients learn to remain present within the moment, become aware of their urges, and focus on accepting thoughts and feelings rather than suppressing or changing them. It utilizes visual imagery to assist clients in utilizing more acceptance skills; the client imagines his urges as waves within the ocean and then imagines surfing the waves.
~Some interventionists also provide psychoeducation. Clients learn that urges will not last forever; clients are also taught information about reinforcing urges. The interventionist explains that if clients do not reinforce urges (e.g., do not smoke when an urge to smoke arises) they will eventual subside; however, reinforcing urges (smoke when an urge to smoke arises) will produce stronger urges. Emphasis is placed on the belief that clients have the choice to refrain from engaging in urge-related behaviors."
16015419|NCT02771873|Behavioral|Integrated cardiovascular disease risk management.|Health promotion intervention
16015420|NCT02771860|Drug|denosumab|60mg sc
16015421|NCT02771860|Drug|Placebo|identical syringe
16015422|NCT02771860|Dietary Supplement|Calcium/Vit D supplementation|Daily dosage Calcium 1000mg / Vit D 880 IU
16015423|NCT02771847|Behavioral|survey|anonym survey is given to people
16015424|NCT02771834|Other|Biomechanical analysis|
16015425|NCT02771834|Other|Kiphosis analysis|
16015426|NCT02771834|Other|Vitamin D level|
16015427|NCT02771821|Other|Operative groups based on methodology of problematization|"The educational intervention based on the methodology of problematization consisted of the survey prior knowledge on the subject; planning; Implementation and Evaluation through verbalization solutions applicable to the reality of the elderlies.
~Each operative group was composed of an average of 12 to 15 elderlies diabetics who participated in monthly activities lasting 2 hours, for six consecutive months."
16015428|NCT02771808|Other|biomarker samples|biomarker samples for haptoglobin genotype (RT-PCR) and phenotype (hemoglobin electrophoresis) general markers for oxidative stress (isoprostane f2 alpha, malondialdehyde) markers of inflammation (CRP, IL-1, 2, 6, 10 and TNF) markers of cardiac injury (CPK, troponins and BNP) markers of kidney injury (cystatin C, creatinine, GFR)
16015429|NCT02771795|Drug|Herceptin (trastuzumab)|Intravenous administration
16015430|NCT02771795|Drug|SB3 (proposed trastuzumab biosimilar)|Intravenous administration
16015431|NCT02771782|Biological|BCG vaccine (SSI)|
16015432|NCT02771782|Biological|TDaP-IPV vaccine|
16015433|NCT02771769|Other|blood draw|Participants will have a venous blood draw of ~20mLs before prostate biopsy. The biopsy will then be performed and histologically graded for any malignancy present. This grade will be statistically analyzed with respect to the Copy Number Instability (CNI) determined from the results of the molecular examination of the cell-free DNA in the blood.
16015434|NCT02771756|Dietary Supplement|zhen qishen capsule and Oral Supplement of Yuyikang|
16015435|NCT02771756|Dietary Supplement|zhen qishen capsule placebo and Oral Supplement of Yuyikang placebo|
16015436|NCT02771756|Radiation|chemotherapy|
16015437|NCT02771756|Other|nutrition education|
16015438|NCT02771743|Drug|Cisplatin|
16015439|NCT02771743|Drug|Doxorubicin|
16015440|NCT02771743|Drug|Etoposide|
16015441|NCT02771743|Drug|Cyclophosphamide|
16015442|NCT02771743|Drug|Ifosfamide|
16015443|NCT02771743|Drug|Carboplatin|
16015444|NCT02771743|Procedure|Tandem HDCT/auto-SCT|
16015445|NCT02771743|Radiation|Radiotherapy|
16015446|NCT02771743|Drug|Interleukin-2|
16015447|NCT02771743|Drug|Isotretinoin|
16015448|NCT02771743|Radiation|MIBG|
16015449|NCT02771730|Biological|Ad4-mgag|A live replication-competent Adenovirus type-4 vector encoding a mosaic HIV Gag antigen, delivered orally by enteric-coated capsules.
16015450|NCT02771730|Biological|Ad4-EnvC150|A live replication-competent Adenovirus type-4 vector encoding an HIV clade C Env protein (gp150 1086.C), delivered orally by enteric-coated capsules.
16015451|NCT02771730|Other|Placebo Comparator|Oral sucrose capsules
16015494|NCT02771418|Procedure|Elective carotid endarterectomy|
16015495|NCT02771405|Drug|Sofosbuvir|Sofosbuvir 400 mg orally once daily
16015452|NCT02771730|Biological|AIDSVAX B/E|300 mcg of subtype B (MN) HIV gp120 glycoprotein and 300 mcg of subtype E (A244) HIV gp120 glycoprotein adsorbed onto 600 mcg of aluminum hydroxide gel adjuvant, administered intramuscularly (IM).
16015453|NCT02771717|Drug|Budesonide (Pulmicort)|Budesonide (Pulmicort) - inhaled low dose inhaled steroid - I puff to be taken twice daily
16015454|NCT02771717|Drug|Placebo - dummy inhaler|Placebo - dummy inhaler to be taken 1 puff twice daily.
16015455|NCT02771704|Other|Silver Diamine fluoride|
16015456|NCT02771704|Other|Potassium iodide|
16015457|NCT02771704|Other|Chlorhexidine|
16015458|NCT02771704|Other|Silver diamine fluoride and potassium iodide|
16015459|NCT02771704|Other|Physiological saline|
16015460|NCT02771691|Other|Mentalization-Based Group Therapy for Adolescents|
16015461|NCT02771665|Other|Mammographic breast density at diagnosis|Mammographic breast density at diagnosis
16015462|NCT02771652|Behavioral|e-training|The e-training intervention is a home-based aerobic and resistance training program. Resistance training was prescribed twice weekly for a period of 12 weeks. No special equipment was necessary except an elastic exercise band or a large gymnastic ball. In addition, endurance training was to be carried out once a week. Training intensity was regulated by the participant's subjective, perceived exertion, which was rated between 6 and 20 on the BORG Scale. The form of activity for the endurance training was freely selected, duration (between 10-60 min) was adjusted to individual fitness levels. Therapists aimed at eliciting a BORG Feedback of between 11 (fairly light) and 16 (hard). The exercise training was home-based and supervised via the internet. Participants continued exercise training for another 12 weeks after the 3month assessment.
16015463|NCT02771652|Other|Control|After the initial assessment on entry, those assigned to the control group were instructed to maintain their previous physical activity behaviour. After waiting three months, they received the same e-training intervention as the intervention group had received from the start.
16015464|NCT02771639|Procedure|Hip arthroplasty|Treatment with a hip arthroplasty (semi- or total hip arthroplasty) for a displaced femoral neck fracture
16015465|NCT02771626|Drug|CB-839|Glutaminase inhibitor
16015466|NCT02771626|Drug|Nivolumab|PD-1 inhibitor
16015467|NCT02771613|Other|Multi professional in situ simulation|After the analysis of adverse effects in Morbidity Mortality reviews, we will create scenarios adapted to these events. Education of the randomized department's arm's staff will be performed by multi professional in situ simulation with these scenarios
16015468|NCT02771613|Other|Large diffusion of information|After the analysis of adverse effects in Morbidity Mortality reviews a large scale dissemination activity of information about discussions and decisions towards the staff of the randomized departments' arms will be carried out
16015469|NCT02771600|Device|Buzzy|See arm description
16015470|NCT02771600|Drug|Topical anaesthetic cream|See arm description
16015471|NCT02771587|Dietary Supplement|Alcohol and energy drink|Multiple oral dose of alcohol Multiple oral dose of energy drink
16015472|NCT02771587|Dietary Supplement|Alcohol|Multiple oral dose of alcohol
16015473|NCT02771587|Dietary Supplement|Energy drink|Multiple oral dose of energy drink
16015474|NCT02771587|Dietary Supplement|Placebo|Multiple oral dose of water Multiple oral dose of non-caffeinated soft drink
16015475|NCT02771574|Drug|Lyo avexitide|Lyophilized avexitide (Lyo avexitide) administered subcutaneously (sc)
16015476|NCT02771574|Drug|Liq avexitide|Liquid avexitide (Liq avexitide) administered subcutaneously (sc)
16015477|NCT02771561|Procedure|Patent Foramen Ovale Closure|Transoesophageal guided percutaneous patent foramen ovale closure using Gore™ septal occluder device
16015478|NCT02771548|Procedure|Anterior Cruciate Ligament Reconstruction|
16015479|NCT02771535|Behavioral|D-MCT|Metacognitive Training for Depression (D-MCT), 8 sessions (60min); twice a week over a period of 4 weeks. Metacognitive Training for depression (D-MCT) is a low-threshold, easy to administer group intervention. It aims at the reduction of depressive symptoms by changing cognitive biases; not only biases targeted in cognitive behavioral therapy but also those identified by basic research.
16015480|NCT02771535|Behavioral|Health Training|Health Training Group (Walking/ Psychoeducation on health); 8 sessions (60min), twice a week over a period of 4 weeks
16015481|NCT02771522|Device|Calcivis System|Following de-bond, and identification of active post-orthodontic white spot lesions at baseline with the Calcivis System, each active tooth will be again be imaged at 2, 4, 8 and 12 weeks. Both black & white and luminescent images images of the teeth are taken. The images of each tooth are overlaid and a resulting demineralization map of the tooth produced, indicating areas of elevated bioluminescence corresponding to free calcium ions on the surface of the tooth (active caries)
16015482|NCT02771509|Drug|ANG-3777|6 mg/mL BB3, IV, 4 days in a row, first dose must be within 4 hours after surgery, the next three doses will be approx. 24 hours after the last dose
16015483|NCT02771509|Drug|Placebo|Normal saline
16015484|NCT02771496|Other|Other: observational only- no intervention|Other: observational only- no intervention
16015485|NCT02771470|Drug|Probiotics|Microbial composition using probiotic
16015486|NCT02771470|Drug|placebo|Microbiota modulation using placebo
16015487|NCT02771457|Drug|Infliximab at weeks 0,2, and 6|
16015488|NCT02771457|Drug|Infliximab at weeks 0,4, and 8|
16015489|NCT02771457|Drug|Infliximab at weeks 0 and 8|For physicians who do not feel comfortable enrolling patients in a randomized trial of infliximab re-induction they will have the option of enrolling their patients in an arm that resumes maintenance therapy only instead at 0 and 8 weeks.
16015490|NCT02771444|Device|Tomo Assessment|A four-view tomosynthesis examination
16015491|NCT02771431|Other|Tele-rounding in post operative care|Both groups will receive standard of care. The only difference between these groups would be the physical presence of the attending in the room. Both groups will receive a physical exam with supervision of the attending, one group will have attending in the room and the other will have the attending present via I-pad. In both cases if there was something of concern the attending would step in for the physical exam if needed, regardless of which group they were randomized for.
16015492|NCT02771418|Drug|Propofol|Intravenous induction and maintenance of general anesthesia with propofol is a routine practice for this intervention
16015493|NCT02771418|Drug|Sevoflurane|Volatile induction and maintenance of general anesthesia with sevoflurane is a generally acceptable clinical approach for this intervention
16015496|NCT02771405|Drug|Ribavirin|Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16015497|NCT02771405|Drug|Simeprevir|Simeprevir 150 mg orally once daily
16015498|NCT02771405|Drug|daclatasvir|Daclatasvir 60 mg orally once daily
16015499|NCT02771405|Drug|Ledipasvir|Ledipasvir 90 mg orally once daily
16015500|NCT02771392|Drug|Ophthalmic Tetracaine|1-2 drops to affected eye every 15-30 minutes over 24-48 hours as need
16015501|NCT02771392|Other|Normal Saline|1-2 drops to affected eye every 15-30 minutes over 24-48 hours as need
16015502|NCT02771379|Drug|Idebenone|Raxone 900mg/day as per Raxone SmPC and medical judgement of treating physician.
16015503|NCT02771366|Drug|Fermented Papaya Preparation|This will be provided in a 3g sachet for use 3 times a day 30-40 minutes before a meal. This will be done for 8 weeks.
16015504|NCT02771366|Other|Granulated Sugar|This will be provided in a 3g sachet for use 3 times a day 30-40 minutes before a meal. This will be done for 8 weeks.
16015505|NCT02771353|Radiation|WT_vDIBH|
16015506|NCT02771353|Radiation|VMAT_FB|
16015507|NCT02771340|Biological|ICON-1|Intravitreal injection of ICON-1
16015508|NCT02771327|Device|CPAP plus Gas|
16015509|NCT02771327|Device|ventimask plus gas|
16015510|NCT02771314|Drug|AZD9291|AZD9291, 80 mg (tablets) once daily, administered orally in the fasted state
16015511|NCT02771301|Biological|dendritic cells|Concurrent of radiotherapy and chemotherapy plus 12 cycles of dendritic cells and cytotoxic lymphocytes treatment
16015512|NCT02771288|Device|Bioresorbable Vascular Scaffold|
16015513|NCT02771275|Device|Harpoon Medical Device|It is expected that the Harpoon Medical transapical suturing device will be a valuable treatment alternative for patients suffering from mitral valve regurgitation because it can access the left ventricle with a small shaft or via a small valved introducer with a secure anchoring mechanism that can be deployed anywhere on the mitral valve leaflet.
16015514|NCT02771262|Other|Pulmonary Rehabilitation|
16015515|NCT02771249|Drug|rifapentene (RPT)|RPT is a long-acting rifamycin used in combination with INH in the treatment of LTBI.
16015516|NCT02771249|Drug|darunavir/cobicistat (DRV/c)|DRV is a protease inhibitor (PI) indicated in the treatment of HIV infection.33 DRV requires coadministration with RTV (100 mg once or twice daily) or COBI (150 mg daily), the latter of which has been coformulated into a fixed-dose tablet with DRV (DRV/c 800/150 mg).
16015517|NCT02771249|Drug|Isoniazid (INH)|INH is an antimycobacterial agent that can be used alone or in combination with RPT for the treatment of LTBI. Given with Pyridoxine (vitamin B6)
16015518|NCT02771249|Dietary Supplement|Pyridoxine|
16015519|NCT02771210|Biological|Secukinumab|Induction: Week 0,1,2,3 150 mg or 300 mg Secukinumab s.c. Maintenance: 150 mg or 300 mg Secukinumab s.c. every 4 weeks starting at Week 4
16015520|NCT02771210|Drug|Secukinumab Placebo|Induction: Week 0,1,2,3 Secukinumab Placebo s.c. Maintenance: Secukinumab Placebo s.c. every 4 weeks starting at Week 4 until Week 24 followed by 150 or 300 mg Secukinumab s.c. every 4 weeks
16015521|NCT02771197|Drug|Fludarabine|
16015522|NCT02771197|Drug|Melphalan|
16015523|NCT02771197|Drug|Pembrolizumab|
16015524|NCT02771184|Device|Lung Sound Recording System|The lung sounds are recorded over the posterior chest in supine position on an examination table. A foam pad with several lung sound transducers is placed under the back of the subjects. During the recording the subjects wear a nose clip and hold a pneumotachograph with both hands. The subjects are instructed to breath at a certain airflow rate during inspiration, with natural breathing during expiration. Therefore, they receive a real-time feedback for the airflow rate. The airflow signal and the lung sounds from 16 lung sound transducers are recorded simultaneously for 30 seconds.
16015525|NCT02771171|Radiation|CT Scan|CT imaging
16015526|NCT02771158|Drug|Midodrine|midodrine is metabolized to an active metabolite, desglymidodrine, which is an alpha adrenergic antagonist that causes vasoconstriction of both venous and arterial vasculature, thereby increasing blood pressure
16015527|NCT02771158|Drug|placebo|placebo will be administered to double blind the study
16015528|NCT02771145|Device|FID 120947A contact lens disinfecting solution|Investigational 3% hydrogen peroxide solution that uses a platinum catalyst for neutralization and is intended for simultaneous cleaning, protein removal, disinfecting and storage of silicone hydrogel and soft contact lenses
16015529|NCT02771145|Device|Soft contact lenses (SCL)|Commercially available soft contact lenses worn a minimum of 8 hours each day on a daily wear basis for the duration of the study (180 days). A fresh pair will be dispensed on Day 0, Day 30, Day 60, and Day 135.
16015530|NCT02771145|Device|SCL preservative solution|Commercially available solution for rinsing soft contact lenses
16015531|NCT02771132|Behavioral|"12-hr IMPower empowerment self defense course"|"The purpose of the 12-hr IMPower empowerment self defense course intervention for girls is to empower then to avoid risky situations, advocate for themselves, and, if needed, defend themselves against an attack."
16015532|NCT02771132|Behavioral|12-hr Source of Strength for boys|The 12-hr Source of Strength for boys curriculum is specifically designed for 10-13 year-old boys and focused on promoting gender equality, developing positive masculinity, and teaching safe and effective bystander intervention techniques.
16015533|NCT02771132|Behavioral|Life-skills course|A 1.5-2 hour life skills class that is based on the Kenyan Ministry of Education life skills course and includes a wide range of topics, including sexual assault but also sanitation, food safety, and personal rights. All school-aged children who attend school typically receive this type of curriculum.
16015534|NCT02771106|Other|neuro vision rehabilitation|Neuro vision rehabilitation used to treat vision dysfunction following TBI
16015535|NCT02771093|Drug|Trelagliptin|Trelagliptin 100 mg tablet
16015536|NCT02771093|Drug|Alogliptin|Alogliptin 25 mg tablet
16015537|NCT02771080|Procedure|Cardiac surgery|
16015538|NCT02771067|Procedure|Fluid infusion|Fluid infusion will be performed using 6% hydroxyethyl starch. Pulse pressure variation and stroke volume will be measured before and after fluid infusion.
16015539|NCT02771054|Drug|TAF/FTC|Change of nucleoside backbone
16015585|NCT02770690|Drug|placebo|apply normal saline before propofol iv injection
16015586|NCT02770677|Other|Modified Dantien Salee Yoga Training Program|The intervention aims to improve pulmonary function and functional fitness.
16015587|NCT02770664|Drug|Placebo|Placebo
16015540|NCT02771041|Procedure|medical consultation 8 days before surgery|"This consultation would serve to explain to the patient the early course of care, give advice and help to anticipate acts for its release post-operative as, for example, contact a physical therapist and a nurse or check to their community pharmacy if their heparin stock is enough and to answer any questions."
16015541|NCT02771028|Behavioral|Emotional Freedom Techniques|
16015542|NCT02771015|Device|Mepilex Border®|randomization
16015543|NCT02771015|Device|Cosmopor steril®|randomization
16015544|NCT02771002|Device|Peripheral Perfusion index by Carescape Patientenmonitor|Peripheral Perfusion index measured with pulse-oximetry by Carescape Patientenmonitor
16015545|NCT02770989|Procedure|Vimecon Laser CAI percutaneous cardiac ablation|The Vimecon Laser CAI catheter is entered through the femoral vein to access the pulmonary vein (PV) area in the heart in order to ablate the cardiac wall near the PV to create scar tissue and to isolate the PV in order to treat atrial fibrillation.
16015546|NCT02770976|Device|Increasing and decreasing NAVA levels with 10-min intervals|
16015547|NCT02770963|Procedure|Acupuncture|"Shenshu (BL23) on bilateral sides and Dachangshu (BL25), Weizhong (BL40), and Chengshan (BL57) on the affected side will be applied.
~A Huatuo Brand needle (0.3*75 mm) for BL25 will be inserted at a depth of 40-70 mm vertically until the patient feels soreness and a distension sensation that radiates to the leg. The needle will be lifted 1-2 mm without rotating or lifting. Huatuo Brand needles (0.3*40 mm) at the other acupoints (BL23, BL40 and BL57) will be inserted 30 mm and manipulated by lifting, thrusting, twirling evenly until the Deqi sensation is achieved. The needles in these acupoints will be manipulated by small evenly applied lifting, thrusting, and twirling movements 3 times every 10 minutes."
16015548|NCT02770963|Procedure|Sham acupuncture|"Specially designed sham needles (0.3*25 mm) will be used. The sham needle consists of a needle handle, needle body, blunt tip and a sterile polyethylene cylindrical foam pad (identical to the pads in the acupuncture group).
~The acupoints will be the same as the acupuncture group. The needle will be inserted vertically until pressed against the skin without penetration. The manipulation will be consistent with the acupuncture group and blind to the patients."
16015549|NCT02770950|Drug|Zushima plaster with high dose|Patients in high dose Zushima plaster group will use Zushima plaster topically on knee(s) for 24h per day.
16015550|NCT02770950|Drug|Zushima plaster with low dose|Patients in low dose Zushima plaster group will use Zushima plaster topically on knee(s) for 12h per day.
16015551|NCT02770950|Drug|Indometacin Cataplasms|Patients in Indometacin Cataplasms group will use Indometacin Cataplasms on knee(s)for 24h per day.
16015552|NCT02770937|Other|Virtual reality simulator|The virtual reality simulator group will receive a maximum of 4 hours of training (2 sessions, 2 hours each) using the Simbionix simulator on laparoscopic suturing.
16015553|NCT02770937|Other|Box trainer|The box trainer group will receive a maximum of 4 hours of training (2 sessions, 2 hours each) on a box trainer.
16015554|NCT02770937|Device|Simbionix|
16015555|NCT02770924|Device|AT LISA TRI TORIC|phacoemulsification with IOL implantation
16015556|NCT02770924|Device|AT LISA TRI|phacoemulsification with IOL implantation
16015557|NCT02770911|Procedure|"without Dog Ear group"|a modified double-stapling technique with eliminating the dogears in laparoscopic anterior resection
16015558|NCT02770911|Procedure|"with Dog Ear group"|a traditional double-stapling technique without eliminating the dogears in laparoscopic anterior resection
16015559|NCT02770898|Behavioral|Family Holistic Health|Interventions for probationers will aim to promote physical and psychosocial health, family relationships and Family 3H (happiness, harmony and health).
16015560|NCT02770885|Drug|Dulaglutide|Treatment with dulaglutide for 3 weeks.
16015561|NCT02770885|Drug|Placebo|Treatment with Sodium Chloride 0.9% (Placebo) for 3 weeks.
16015562|NCT02770872|Other|Observation of SAA on apoB containing lipoproteins|attempting to elicit the conditions by which SAA shifts from apo-A1 containing lipoproteins to apoB containing lipoproteins
16015563|NCT02770859|Procedure|POEM (Per Oral Endoscopic Myotomy)|Per-Oral endoscopic myotomy (creating a muscle [esophagus] opening), an incision-less (no cutting of the surface of the body) endoscopic procedure, is an effective non-surgical alternative to release the muscle & sphincter of the LES for the treatment of achalasia
16015564|NCT02770846|Procedure|Immediate loading|
16015565|NCT02770846|Procedure|Delayed loading|
16015566|NCT02770833|Other|Fish and carbohydrats with low or high GI|
16015567|NCT02770833|Other|Veal and carbohydrats with low or high GI|
16015571|NCT02770807|Drug|EDS-EP dose range of ~5-10 mg DSP/infusion|infusion
16015572|NCT02770807|Drug|EDS-EP dose range of ~14-22 mg DSP/infusion|infusion
16015573|NCT02770807|Drug|Placebo|infusion
16015574|NCT02770794|Drug|Infliximab|Discontinue infliximab; receive Infliximab when relapse
16015575|NCT02770781|Other|Exercise regimen|Subjects will receive a personal exercise regimen based on their health history and individual capability.
16015576|NCT02770768|Drug|Flibanserin|Observational study using electroencephalogram (EEG) and eye movement tracking device at baseline, week 4, and week 8 while subjects are taking either Flibanserin or matching placebo.
16015577|NCT02770768|Drug|Placebo|Observational study using electroencephalogram (EEG) and eye movement tracking device at baseline, week 4, and week 8 while subjects are taking either Flibanserin or matching placebo.
16015578|NCT02770729|Drug|Moxifloxacin|Intracameral injection of moxifloxacin at conclusion of cataract surgery
16015579|NCT02770729|Drug|No injection of moxifloxacin|No intracameral injection of moxifloxacin at conclusion of cataract surgery
16015580|NCT02770716|Drug|Terlipressin|Each 6 mL vial contains 1 mg lyophilized terlipressin acetate and 10 mg mannitol in sterile 0.9% sodium chloride solution
16015581|NCT02770716|Other|Placebo Comparator|11 mg mannitol reconstituted with 5 ml of sterile 0.9% sodium chloride solution
16015582|NCT02770703|Device|DynaMesh visible mesh|Implantation of a MRI visible mesh
16015583|NCT02770690|Drug|ethyl chloride spray|apply the spray for 5 seconds on the dorsal hand before propofol iv injection
16015584|NCT02770690|Drug|lidocaine|apply lidocaine under the tourniquet state before propofol iv injection
16015591|NCT02770651|Device|Everolimus-Eluting stent|Everolimus-Eluting stent with bioabsorbable polymer
16015592|NCT02770651|Device|Zotarolimus-Eluting stent|Zotarolimus-Eluting stent with permanent polymer
16015593|NCT02770638|Device|Scoop Stretcher|Participants recruited by community advertisement. Participant will complete forty five minutes on scoop stretcher first, followed by forty five minute washout period, finished with forty five minutes on the long back spinal board. Tissue pressures will be automatically recorded throughout the forty five minute period laid on either spinal board. In addition, participants will be asked to report their comfort levels at five minute intervals.
16015594|NCT02770638|Device|Long Back Spinal board|Participants recruited by community advertisement. Participant will complete forty five minutes on the long back spinal board first, followed by forty five minute washout period, finished with forty five minutes on the scoop stretcher. Tissue pressures will be automatically recorded throughout the forty five minute period laid on either spinal board. In addition, participants will be asked to report their comfort levels at five minute intervals.
16015595|NCT02770625|Drug|ISU302|60 U/kg given intravenously
16015596|NCT02770612|Other|Prescribed opioids|Making a shared decision with post-cesarean delivery mothers about quantity of opioids prescribed at discharge
16015597|NCT02770599|Other|IBD multidisciplinary team model including IBD nurse|IBD multidisciplinary team model including IBD nurse
16015598|NCT02770586|Diagnostic Test|Breast PET|imaging of the breast using the Breast PET system
16015599|NCT02770573|Other|Cavex Bite&White ExSense|a water-based mint aroma gel containing hydroxyapatite and potassium nitrate.
16015600|NCT02770573|Other|Kuraray Teethmate™ Desensitizer|Calcium-Phosphate-based powder and a liquid mainly water-based.
16015601|NCT02770573|Other|Ghimas Dentin Desensitizer|a fluid desensitizing gel with 30% of nano-hydroxyapatite, added to 70:100 thousandths of micron-sized crystals of nano- hydroxyapatite.
16015602|NCT02770560|Device|Urokinase locking solution|On basis of the prescription : one single administration of thrombolytic locking solution versus multiple administrations (during 3 consecutive dialysis sessions)
16015603|NCT02770547|Device|Low Heat Thermotherapy|Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies low heat to the subject's leg.
16015604|NCT02770547|Device|High Heat Thermotherapy|Subject will wear a High Density LCG (Liquid Circulating Garment). Water will be heated and circulated through the garment, which in turn supplies high heat to the subject's leg.
16015605|NCT02770534|Procedure|blood test|10mls extra mls of blood taken during usual phlebotomy procedures
16015606|NCT02770521|Drug|Treprostinil|Administered SC.
16015607|NCT02770521|Drug|Placebo|Administered SC.
16015608|NCT02770521|Drug|LY900014|Administered SC.
16015609|NCT02770521|Drug|Insulin Lispro|Administered SC.
16015610|NCT02770508|Drug|darunavir/ritonavir|
16015611|NCT02770508|Drug|Lamivudine|
16015612|NCT02770508|Drug|emtricitabine-tenofovir(FTC/TDF)|
16015613|NCT02770495|Other|blood sample|
16015614|NCT02770482|Biological|spinal fluid collection|
16015615|NCT02770469|Behavioral|Linguistically and Culturally Tailored Information|Participants received linguistically and culturally tailored information on diet and nutrition, physical activity, managing treatment side effects, follow-up care plans, complementary and alternative medicine, reducing environmental exposure to estrogen, navigating cancer-related financial issues, family history, body image, sexuality, and advances in breast cancer research.
16015616|NCT02770469|Behavioral|Cognitive-Behavioral Stress Management|Participants learned and practiced skills related to mindfulness, relaxation, stress reduction, rational thinking, improving coping, enhancing social support, anger management, and assertiveness training.
16015617|NCT02770456|Dietary Supplement|High dose fish oil|Four 0.72-gram gelatine capsules per day with fish oil providing 2.0 g/d lc-n3FA
16015618|NCT02770456|Dietary Supplement|Low dose fish oil|Four 0.72-gram gelatine capsules per day with a mixture of fish oil and olive oil providing 0.5 g/d lc-n3FA
16015619|NCT02770456|Dietary Supplement|Olive oil|Four 0.72-gram gelatine capsules per day with olive oil providing 0 g/d lc-n3FA
16015620|NCT02770443|Drug|withdrawal|withdrawal of beta blocker and ACE inhibitors
16015621|NCT02770443|Drug|standard of CARE|STANDARD OF CARE, NO WITHDRAWAL OF MEDICAL THERAPY
16015622|NCT02770430|Biological|mesenchymal stem cells|MSCs derived from bone marrow (BM) will be isolated and expanded in the laboratory under conditions of Good Manufacturing Practice. The quality control involves immunophenotyping, differentiation, microbiological control, mycoplasma and endotoxin tests. Patients will receive five infusions of MSC. Dosage: 2x10E6 cells/Kg
16015623|NCT02770430|Drug|conventional treatment|"Basiliximab 20mg dose for adults and 10mg for children, 1 time a week or every 3 days if worsens the stage of GVHD until reaching Very Good Partial Response (VGPR) or for a maximum of 4 doses, whichever comes first.
~If after the item (1) will not obtained VGPR: Infliximab 5 to 10 mg/kg dose, 1 time a week, four weeks or even VGPR."
16015624|NCT02770417|Dietary Supplement|beta-alanine|Patients receive beta-alanine
16015625|NCT02770417|Dietary Supplement|placebo|Patients receive placebo
16015626|NCT02770417|Other|control|Healthy controls will be assessed to compare baseline muscle carnosine levels
16015627|NCT02770404|Drug|Nafithromycin|100, 200, or 400 mg of nafithromycin
16015628|NCT02770404|Drug|Placebo|IV matching placebo
16015629|NCT02770391|Drug|Leuprolide acetate|Leuprolide acetate, Intramuscular injection - 7.5 mg, one time dose on day (-28) ± 3
16015630|NCT02770391|Drug|Apalutamide|Apalutamide, PO, 240 mg daily, starting day (-28) ± 3 until the day before radical prostatectomy. Apalutamide will be initiated the same day patients receive their leuprolide acetate injection.
16015631|NCT02770391|Procedure|Radical prostatectomy|
16015632|NCT02770378|Drug|Temozolomide|Patients will receive temozolomide at a dose of 20 mg/m² BSA twice daily with start day 1 during induction and treatment cycles
16015633|NCT02770378|Drug|Aprepitant|Patients will receive aprepitant at a dose of 80 mg p.o. once daily with start day 1 during induction and treatment cycles
16015634|NCT02770378|Drug|Minocycline|Induction cycle day 3-4: minocycline 50 mg p.o. twice daily from day 19-20; minocycline 100 mg p.o. twice daily during treatment cycle 1-12 (28 days); minocycline 100 mg p.o. twice daily
16015707|NCT02769845|Drug|Hydroxyurea|drug to be administered
16015635|NCT02770378|Drug|Disulfiram|Induction cycle day 5-6: disulfiram 250 mg p.o. once daily from day 21-22; disulfiram 250 mg p.o. twice daily during treatment cycle 1-12 (28 days); disulfiram 250 mg p.o. twice daily
16015636|NCT02770378|Drug|Celecoxib|Induction cycle day 1-35: day 7-8: celecoxib 200 mg p.o. twice daily from day 23-24; celecoxib 400 mg p.o. twice daily during treatment cycle 1-12 (28 days); celecoxib 400 mg p.o.twice daily
16015637|NCT02770378|Drug|Sertraline|Induction cycle day 1-35: day 9-10: sertraline 50 mg p.o. twice daily, day 31-32: sertraline 100 mg p.o. twice daily; treatment cycle 1-12: sertraline 100 mg p.o. twice daily
16015638|NCT02770378|Drug|Captopril|Induction cycle day 1-35: day 11-12: captopril 25 mg p.o. twice daily, day 25-26: captopril 50 mg p.o. twice daily; treatment cycle 1-12 (28 days): captopril 50 mg p.o. twice daily
16015639|NCT02770378|Drug|Itraconazole|Induction cycle day 1-35: day 13-14: itraconazole 200 mg p.o. once daily day 27-28; itraconazole 200 mg p.o. twice daily; treatment cycle 1-12 (28 days): itraconazole 200 mg p.o.twice daily
16015640|NCT02770378|Drug|Ritonavir|Induction cycle day 1-35: day 15-16: ritonavir 200 mg p.o. once daily, day 29-30: ritonavir 200 mg p.o. twice daily, day 35: ritonavir 400 mg p.o. twice daily; treatment cycle 1-12 (28 days): ritonavir 400 mg p.o. twice daily
16015641|NCT02770378|Drug|Auranofin|Induction cycle day 1-35: day 17-18: auranofin 3 mg p.o. once daily, day 33-34 auranofin 3 mg p.o. twice daily; treatment cycle 1-12 auranofin 3 mg p.o. twice daily
16015642|NCT02770365|Drug|estrace cream (Perrigo)|
16015643|NCT02770365|Drug|estrace cream (Reference)|
16015644|NCT02770365|Drug|Placebo cream|
16015645|NCT02770326|Biological|Fecal Microbiota Transplantation (FMT)|
16015646|NCT02770313|Behavioral|Intermittent Fasting|Subjects allocated to the fasting arm will undergo a fasting regimen of twice-per-week 24-hour fasting on non-consecutive days during the first 4 weeks of the study, then once-per-week 24-hour fasting during the rest of the study (22 weeks).
16015647|NCT02770300|Device|Arm Light Exoskeleton Rehab Station (ALEx RS)|ALEx RS is a complete system specifically designed to support the rehabilitation of stroke patients. In particular, this system is equipped with a robotic arm exoskeleton conceived for the force assistance, integrated in a Virtual Reality system that allows implementing rehabilitative exercises highly interactive and engaging for the patients. It is proven that the use of this type of devices in rehabilitation can provide high intensive, repetitive, task specific, and interactive treatment of the impaired arm and an objective and reliable mean for monitoring patients' progress.
16015648|NCT02770300|Device|Arm Light Exoskeleton Rehab Station (ALEx RS) - automatically personalized|ALEx RS is a complete system specifically designed to support the rehabilitation of stroke patients. In particular, this system is equipped with a robotic arm exoskeleton conceived for the force assistance, integrated in a Virtual Reality system that allows implementing rehabilitative exercises highly interactive and engaging for the patients. It is proven that the use of this type of devices in rehabilitation can provide high intensive, repetitive, task specific, and interactive treatment of the impaired arm and an objective and reliable mean for monitoring patients' progress. The movements to be performed by the patient are automatically decided by the exoskeleton.
16015649|NCT02770287|Device|Venus Freeze Diamond Polar|The Venus Freeze Diamond Polar is a non-invasive dermatological treatment system that combines Multi Polar Radiofrequency and Pulsed Magnetic Fields. The radiofrequency energy penetrates the skin and results in tissue heating that has known effect on skin laxity, the magnetic field that is simultaneously induces increases fibroblast collagen production through non thermal mechanism and contributes to the clinical effect of skin laxity improvement. Only the Diamond Polar applicator will be used in this study for the treatment of the Mons pubis, vaginal introitus and Labia. Minor modification to the hand-piece for operator and/or patient comfort may occur mid-study, however no change in range of energy modality or amount of energy delivered will occur at any point during the study.
16015650|NCT02770274|Drug|Cilostazol|Dual therapy with Cilostazol 100 mg twice daily
16015651|NCT02770274|Drug|Aspirin|Monotherapy with aspirin 100 mg once daily
16015652|NCT02770261|Drug|DP-R208|DP-R208 + Candesartan 32mg placebo + Rosuvastatin 20mg placebo
16015653|NCT02770261|Drug|Candesartan32mg|DP-R208 placebo + Candesartan 32mg + Rosuvastatin 20mg placebo
16015654|NCT02770261|Drug|Rosuvastatin 20mg|DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg
16015655|NCT02770261|Drug|DP-R208 Placebo|DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg
16015656|NCT02770261|Drug|Candesartan32mg Placebo|DP-R208 placebo + Candesartan 32mg placebo + Rosuvastatin 20mg
16015657|NCT02770261|Drug|Rosuvastatin 20mg Placebo|DP-R208 placebo + Candesartan 32mg + Rosuvastatin 20mg placebo
16015658|NCT02770248|Drug|Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension|
16015659|NCT02770248|Drug|Vehicle|Inactive ingredients used as a placebo for masking purposes
16015660|NCT02770235|Other|DE assessment|by a validated self-administered questionnaire: Index International erectile function (IIEF-15)
16015661|NCT02770235|Other|AGE measurement|By AGE-ReaderTM
16015662|NCT02770222|Drug|Selexipag|Two selexipag film-coated tablets of 200 µg as single oral dose (total dose = 400 µg)
16015663|NCT02770222|Drug|Gemfibrozil|Gemfibrozil film-coated tablet of 600 mg administered orally b.i.d. from Day 1 to Day 9
16015664|NCT02770222|Drug|Rifampicin|Rifampicin film-coated tablet of 600 mg administered orally o.d.from Day 1 to Day 9
16015665|NCT02770209|Biological|biomimetic cartilage matrix + autologous chondrocytes|
16015666|NCT02770209|Procedure|arthroscopic debridement|
16015667|NCT02770209|Procedure|microfracture surgery|
16015668|NCT02770196|Behavioral|CO-CSA plus Nutrition Education|Participants will receive subsidized share of CSA produce (50% standard member price) weekly for approximately 20 weeks each year. In addition, they will attend nine skill-based, nutrition education sessions focused on use of CSA produce.
16015704|NCT02769871|Behavioral|Neuroimages of stroke|Participants in the intervention group will be shown computer images of head CT or brain MRI (DWI/FLAIR series) of their strokes. Basic orientation to neuroimaging (laterality, positioning, parts of the brain) will be provided first, and then the image of the stroke itself will be reviewed. Participants will be provided with a paper copy of the slice demonstrating the largest volume of stroke to keep. In comparison, patients will also be shown images of a normal healthy, and images of a patient with recurrent strokes due to smoking. Patients will be told that smoking cessation would help to prevent additional stroke, but that it would not repair the damage already done, as visualized on the neuroimaging.
16015669|NCT02770183|Device|Imacor|"In ICU, the doctors in charge places the probe in the esophagus, executing a series of morphological evaluations and semi-quantitative evaluations. Each image is saved as a video loop or a static image, to have a basic data for each patient and perform an off-line analysis. At the end of the first recording, the esophageal probe is left in the neutral position in the stomach, to eliminate any risk associated with a local increase of pressure.
~During the stay in the intensive care unit until the end of the study, the esophageal probe will be left in the neutral position, to run every two hours a new echocardiographic assessment on the main window, similar to the first evaluation, always recording loop-video and photographs, to have a time course of recovery of cardiac contractile function. All images will be stored in a digital archive."
16015670|NCT02770170|Drug|BI 655064 dose 1|
16015671|NCT02770170|Drug|BI 655064 dose 2|
16015672|NCT02770170|Drug|BI 655064 dose 3|
16015673|NCT02770170|Drug|Placebo|
16015674|NCT02770157|Drug|DA-3002|
16015675|NCT02770157|Drug|Genotropin®|
16015676|NCT02770144|Behavioral|Financial Coaching|Enrollment in one-to-one financial coaching intervention to support savings, income, and credit while reducing debt using available tools in the community development field.
16015677|NCT02770144|Behavioral|Access to Referral to Social Services|
16015678|NCT02770118|Behavioral|Partial Sleep Restriction|4 hour time in bed (TIB), participants will go to bed 4 hours later than during the HS condition. Wake-up times will be the same. During the in-lab portion of the PSR, meals, fulfilling weight-maintenance energy requirements, will be supplied by the research staff as BOOST shakes.
16015679|NCT02770118|Behavioral|Total Sleep Deprivation|0 hour time in bed (TIB), participants will remain awake throughout the night. Meals will be provided as BOOST shakes at the same meal.
16015680|NCT02770118|Behavioral|Habitual Sleep|8 hours time in bed (TIB), for 3 nights, with fixed bed and wake times, while at home. During the 3-d HS phase, participants will be provided will BOOST meal replacement shakes in amounts required to achieve weight maintenance.
16015681|NCT02770105|Other|Theanine|Oral administration of 200mg of L-theanine powder dissolved in 200ml of distilled water
16015682|NCT02770105|Other|Caffeine|Oral administration of 160mg of anhydrous caffeine powder dissolved in 200ml of distilled water
16015683|NCT02770105|Other|Theanine-Caffeine Combination|Oral administration of 200mg of L-theanine and 160mg of anhydrous caffeine powder, dissolved in 200ml of distilled water
16015684|NCT02770105|Other|Placebo|Oral administration of 200ml of distilled water
16015685|NCT02770092|Other|sip feeding with stable isotope infusion|such as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline
16015686|NCT02770066|Device|Percutaneous transluminal renal angioplasty|"Angioplasty plus stenting (angioplasty in patients with fibromuscular dysplasia)
~Adjuvant therapy in atherosclerotic renal artery stenosis - at the discretion of the treating physician
~Antiplatelet therapy (usually standard)
~Cholesterol-lowering drugs (usually standard)
~Antihypertensive treatment with angiotensin-converting-enzyme inhibitor or angiotensin-receptor blocker (normally not contraindicated)
~Smoking cessation, diet and physical activity (usually standard)"
16015687|NCT02770053|Procedure|Foraminal enlargement|After determining the working length, a flexible size 30 K-file will be inserted 1 mm beyond the WL and the apical foramen will be enlarged.
16015689|NCT02770027|Drug|Intravenous Crystalloid|Crystalloid is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture
16015690|NCT02770027|Drug|Intravenous HES|HES is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture
16015691|NCT02770014|Drug|Erlotinib|
16015694|NCT02769936|Drug|D-cycloserine|100 mg D-cycloserine administered orally as encapsulated pill
16015695|NCT02769936|Other|Placebo|Placebo administered orally as encapsulated pill
16015696|NCT02769923|Device|Westpharma ID adapter|device used for administering intradermal injection
16015697|NCT02769923|Device|Star ID syringe|device used for administering intradermal injection
16015698|NCT02769923|Device|BCG NS|syringe used for administering intradermal injection
16015699|NCT02769910|Drug|Capsaicin 24 Hours|Dermal patches for transdermal application of Capsaicin, applied for 24 hours
16015700|NCT02769910|Drug|Capsaicin 1 Hour|Dermal patches for transdermal application of Capsaicin, applied for 1 hour
16015701|NCT02769910|Other|Qutenza Demo Patch|Dermal patches mimicking active Qutenza patches. Used as control in comparison of Capsaicin efficacy. Applied for 24 hours.
16015702|NCT02769897|Behavioral|Physical exercise|The sessions will last two hours (one hour of physical exercise and the second time divided into nutritional counseling, postural, psychological and oral) with a frequency of three times a week.
16015703|NCT02769884|Device|MMPPC algorithm artificial pancreas|An artificial pancreas system using the MMPPC algorithm, Roche insulin pump, and Dexcom CGM
16015705|NCT02769871|Behavioral|standardized smoking cessation counseling|Standardized smoking cessation counseling will be provided at their initial interview. They will be provided pamphlets from the National Stroke Association and the American Heart Association regarding risk factor reduction. Packets will include general information on risks associated with smoking along with the benefits of cessation, and methods to quit. Pamphlets will include Life's Simple 7 (American Heart Association, 2014) and Be Smoke Free: Facts about Smoking and Stroke Risk (National Stroke Association, 2009). Counseling will be scripted and standardized to ensure similar language with all participants.
16015708|NCT02769845|Procedure|TCD examination|TCD examinations on children with SCA between ages 3-15 years will be completed to evaluate their risk of stroke. All enrolled children will undergo yearly TCD examination. Participants with conditional TCD velocities on hydroxyurea therapy per study protocol will undergo TCD examinations every 6 months.
16015709|NCT02769832|Drug|Nab-paclitaxel|Nab-paclitaxel 100 mg/m2, day 1, 8 q 21 days
16015710|NCT02769832|Drug|Gemcitabine|Gemcitabine 1000 mg/m2, day 1, 8 q 21 days
16015711|NCT02769819|Device|Flexible fiberscope|"Characteristics of patients will be assessed before induction of general anesthesia
~Glottic visualization will be evaluated by direct laryngoscopy.
~The endotracheal tube will be loaded onto the scope after silicon spray lubrication
~Intubation will be performed with the flexible fiberscope with the patient in supine position with head and neck in neutral position
~With the tip of the fiberscope in satisfactory position, the endotracheal tube will be advanced into the trachea. The scope will then be removed.
~Accurate positioning of the endotracheal tube will be confirmed by capnography and lung auscultation."
16015712|NCT02769806|Procedure|MRI|
16015713|NCT02769793|Drug|Levodopa dispersible|Levodopa dispersible 100mg/tablet, PO, 1 tablet in the morning, once daily for 4 weeks (crossover)
16015714|NCT02769793|Drug|Levodopa|Levodopa 100mg/tablet, PO, 1 tablet in the morning, once daily for 4 weeks (crossover)
16015715|NCT02769767|Genetic|Polymorphism of Interleukins, Glypican, and Human Leukocyte Antigen Genes.|The frequencies of the polymorphic variants in subjects with MS and healthy subjects were evaluated. Also in subjects with MS, the response to treatment with the number of relapses and EDSS was assessed; to compare the allele frequencies of SNPs of Interleukins, Glypican, and Human Leukocyte Antigen Genes, between responders and no responders MS patients.
16015716|NCT02769754|Device|Hemopatch|Hemopatch will be apply once the standard surgical hemostasis is achieved.
16015717|NCT02769754|Other|Control|No additional treatment will be applied after performing the usual surgical hemostasis.
16015718|NCT02769741|Other|Cashews followed by Control|Participants will receive the active diet with cashew nuts as a daily snack during Test Period I at a calorie level to achieve weight maintenance, and with a macronutrient composition representative of a typical diet for 28 days. Following a 14-day washout period, subjects will receive the control diet at the same calorie level, but with a control snack instead of cashew nuts during Test Period II.
16015719|NCT02769741|Other|Control followed by Cashews|Participants will receive a controlled diet without cashew nuts during Test Period I at a calorie level to achieve weight maintenance, and with a macronutrient composition representative of a typical diet for 28 days. Following a 14-day washout period, subjects will receive the active diet at the same calorie level, but with cashew nuts as a daily snack during Test Period II.
16015720|NCT02769728|Device|EndoBarrier|implantation of a duodeno-jejunal bypass liner for weight reduction in obese subjects with type 2 diabetes mellitus
16015721|NCT02769715|Device|Laser-sintered removable partial denture|The master cast was scanned using 3D scanner. In the digital file, the path of insertion was determined using a special software. The survey line was drawn and all undesirable undercuts were eliminated. After that, the entire framework design was built virtually 3 dimensionally using a special software (3Shape Software) according to the specified design in three steps: deciding the contour of the component, building the tissue surface then creating the polished surface. The file was saved in STL file and was transferred to rapid prototyping machine. Framework was produced by selective laser sintering technique using the alloy powder (Sintech Metal).
16015722|NCT02769715|Other|cast removable partial dentures|The denture was fabricated traditionally using lost-wax casting technique.
16015723|NCT02769702|Drug|Acthar|Acthar 80 IU SC twice a week
16015724|NCT02769689|Drug|Methylprednisolone|Included patients will receive either methylprednisolone (1 gramme, 1 day every 4 weeks for a total of 3 grammes) or undistinguishable capsules of placebo
16015725|NCT02769689|Drug|Placebo|Included patients will receive either methylprednisolone (1 gramme, 1 day every 4 weeks for a total of 3 grammes) or undistinguishable capsules of placebo
16015726|NCT02769689|Drug|natalizumab (NTZ)|Patients with MS receiving NTZ for at least 18 months and without any disease activity during the previous year will be eligible. Included patients will receive either methylprednisolone (1 gramme, 1 day every 4 weeks for a total of 3 grammes) or undistinguishable capsules of placebo
16015727|NCT02769689|Drug|fingolimob (FTY)|Every patient will initiate a treatment with FTY 7 weeks after the last NTZ perfusion. Methylprednisolone or placebo will be taken 4, 8 and 12 weeks (W4, W8 and W12) after NTZ discontinuation.
16015728|NCT02769676|Other|3-week visit|The intervention will be an additional visit to the usual postpartum care provider at 3-weeks postpartum.
16015729|NCT02769676|Other|usual care|Participants in the usual care arm will receive no additional interventions.
16015730|NCT02769663|Behavioral|questionnaires and neuropsychological assessments|
16015731|NCT02769650|Procedure|CTO coronary angioplasty|A standard endovascular procedure is carried out under local anesthesia and under fluoroscopic control. Recanalisation of coronary artery CTO is performed by the hydrophilic coronary wire, using the most appropriate technique. Then balloon angioplasty of target lesion is provided. After the angiographic control coronary stent is implanted. After coronary wire removing control angiographic study is provided. Medical therapy includes aspirin(acid acetylsalicylic) 125 - 300 mg/d and plavix(clopidogrel) in dose 300-600 mg prescription before the procedure and heparin (heparin sodium) injection during the procedure(5000 U iv). After the procedure aspirin(acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and plavix(clopidogrel) in dose 75/d should be prescribed within 12 months.
16015732|NCT02769650|Drug|Optimal medicamentous treatment|
16015733|NCT02769650|Procedure|Stress-MRI|A standard stress-MRI test with adenosine
16015734|NCT02769637|Drug|PPI treatment|PPI treatment or no PPI treatment
16015735|NCT02769624|Drug|Treprostinil|A dose of 18mcg (3 breaths) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.
16015736|NCT02769624|Drug|Placebo|3 breaths of placebo (via inhalation devices) will be administered 3 times: at baseline, 1.5 hrs. post baseline and then again 2 hrs later following maximal exercise testing.
16015737|NCT02769611|Drug|Ruboxistaurin|Dose escalation trial. 1st ten patients to receive 64 mg, next 10 patients to receive 128 mg, next 10 patients to receive 256 mg.
16015778|NCT02769325|Drug|Placebo|IV saline, 10 ml
16086732|NCT02259803|Drug|Amlodipine|
16015738|NCT02769598|Device|ANI Index for Hospitalized children|Each file consists of a simultaneous recording of an ECG signal, according to usual practice, coupled with a record of ANI Index (Analgesia Nociception Index) by MetroDoloris®. The ECG signals and the ANI index are recorded simultaneously on a computer.
16015739|NCT02769585|Behavioral|Self-hypnosis|Self-hypnosis
16015740|NCT02769585|Behavioral|CDE training|standard CDE training for an obese diabetic
16015741|NCT02769572|Other|real moxibustion|3 times a week for 4 consecutive weeks,totally 12 sessions at 3 acupoints (ST35, EX-LE4, ST36 )
16015742|NCT02769572|Drug|placebo gel|4 grams per knee, 4 times per day, for 4 weeks
16015743|NCT02769572|Drug|diclofenac sodium gel|4 grams per knee, 4 times per day, for 4 weeks
16015744|NCT02769572|Other|sham moxibustion|3 times a week for 4 consecutive weeks,totally 12 sessions at 3 acupoints (ST35, EX-LE4, ST36 )
16015745|NCT02769559|Procedure|Reduction mammaplasty|Surgical removal of excess breast tissue
16015746|NCT02769546|Other|Surveys|
16015747|NCT02769520|Drug|Pembrolizumab|200 mg will be administered by IV infusion every 3 weeks up to 12 months or until disease progression
16015748|NCT02769507|Device|DC Stimulator PLUS (NeuroConn)|
16015749|NCT02769494|Drug|Mesalazine Sustained-Release Tablets|Mesalazine sustained-release tablets 500mg and 0.02L glycerol mixed, the preparation of 2.5% the mesalazine glycerol suspension liquid, gently apply to the ulcer surface, 3 times/day. The application time of the drug is 8:00,12:00, 16:00. Daily 20:00 measure the size of the mouth ulcers and record the symptoms in the diary card.
16015750|NCT02769494|Drug|Riboflavin Sodium Phosphate Injection|gently apply the riboflavin sodium phosphate injection to the ulcer surface, 3 times/day. The application time of the drug is 8:00,12:00, 16:00. Daily 20:00 measure the size of the mouth ulcers and record the symptoms in the diary card.
16015751|NCT02769481|Drug|Bexagliflozin|20 mg, tablet
16015752|NCT02769481|Drug|Placebo for Bexagliflozin|inactive tablet to match active comparator bexagliflozin
16015753|NCT02769481|Drug|Glimepiride|2, 4 or 6 mg, capsule
16015754|NCT02769481|Drug|Placebo for Glimepiride|inactive capsules to match active comparator glimepiride
16015755|NCT02769468|Other|The Back|
16015756|NCT02769468|Other|Chest|
16015757|NCT02769468|Other|Left Axilla|
16015758|NCT02769455|Other|Reference intakes|"FOP nutrition label which is already in use on a portion of food products in France: the 'Reference Intakes' (RIs). The RIs are a chain of rectangles presenting the contribution of a portion of the product to a reference balanced diet of an average person (2000kcal) for each of the following nutrients: energy, lipids, saturated fat, sugars and sodium.
~The presentation of the products will always include the label affixed on it. Moreover, the product pages will include two pictures of the product: one with only the package (including the RI as FOP labelling), and a picture with both the package and a larger version of the label, so that it is more visible to the participant. These elements ensure higher visibility, awareness and understanding of the label."
16015759|NCT02769455|Other|5-CNL|"The 5-CNL was developed as a colour-coded summary system nutrition label, following the elements pointed out in reviews.
~The format includes five categories, ranging from green (Associated with the A grade) for foods of the highest nutritional quality to red (associated with the E grade), for products with lower nutritional quality. The format is presented in the form of a continuous chain of rectangles, each with its own letter/colour, the one corresponding to the product being enlarged.
~The presentation of the products will always include the label affixed on it. Two pictures of the product will be included: one with only the package (including the 5-CNL as FOP labelling), and a picture with both the package and a larger version of the label, so that it is more visible to the participant."
16015760|NCT02769442|Device|Terumo SurFlash Plus catheter|
16015761|NCT02769442|Device|BD Insyte Autoguard catheter|
16015762|NCT02769429|Device|Ultrasound-guided CISB|This group will receive ultrasound-guided CISB with the catheter placed on the upper trunk of the brachial plexus
16015763|NCT02769429|Device|nerve stimulator-guided CCPVB|This group will receive landmark with nerve stimulator based needle placement and then nerve stimulator-guided CCPVB with the catheter placed on the 6th cervical spinal root
16015764|NCT02769416|Other|Data and sample repository|Subjects with spinal cord and/or traumatic brain injury, family members and healthy volunteers will provide data and samples.
16015765|NCT02769403|Device|HeartMath EmWAVE Pro|"The following information will be recorded about HeartMath use:
~Self-report: adherence (whether the daily session was completed), coherence score, any comments/notes about the daily session From the application: coherence ratio, coherence score, achievement score, session time, average heart rate"
16015766|NCT02769403|Other|Questionnaires|All participants will complete questionnaires at baseline, week 6, and week 12 about demographics, job satisfaction, and job performance.
16015767|NCT02769403|Other|Blood Pressure and Heart Rate|All participants will have blood pressure and heart rate collected at baseline, week 6, and week 12.
16015768|NCT02769403|Other|Sick Days|Sick days during the 12 week study period will be collected
16015769|NCT02769403|Other|Patient Satisfaction|This will include patients who complete the satisfaction survey for the 12 weeks prior to the study and during the 12 week study period. Each patient satisfaction survey is tied to a specific healthcare provider (physicians, Advanced Registered Nurse Practitioner (ARNP) & Physician Assistants [advance practice clinicians], and nurses) and will be linked to the consented research participant.
16015770|NCT02769390|Drug|Clonidine 1 mcg/Kg|Clonidine 1 mcg/Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery
16015771|NCT02769390|Drug|Clonidine 2 mcg/ Kg|Clonidine 2 mcg//Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery
16015772|NCT02769390|Drug|Clonidine 3 mcg/ Kg|Clonidine 3 mcg //Kg associated with bupivacaine 0,166% 1 ml/Kg administred epidural caudal in children for hypospadias surgery
16015773|NCT02769377|Device|Breeze2 glucometer|Breeze2 glucometer for self-monitoring of blood glucose
16015774|NCT02769377|Device|Breeze2 glucometer and H2|Breeze2 glucometer and Health2Sync Mobile App for data transfer
16015775|NCT02769351|Device|periph. minimal invasive ultrafiltration|ultrafiltration via a peripheral single-needle
16015776|NCT02769338|Other|Quality Improvement Program|The Intervention is a QI Program that will include multiple components as described above.
16015777|NCT02769325|Drug|Atropine|IV atropine 0.1%, 10 ml
16015779|NCT02769325|Drug|Sevoflurane|All patients will receive anaesthesia based on sevoflurane, titrated to a bis of 45-60
16015780|NCT02769325|Drug|sugammadex|Patients will receive sugamadex for neuromuscular reversion, if necessary
16015781|NCT02769325|Drug|Ketorolac|60 mg IV ketorolac will be administered at induction, and patients will receive 30mg/8h on the postoperative period
16015782|NCT02769325|Drug|Morphine PCA|Patients will receive a PCA of morphine with a program of 0 (continuous infusion), 1 mg bolus and 8 minutes lockout
16015783|NCT02769325|Drug|rocuronium|general anaesthesia will use rocuronium 0.6 mg/kg to facilitate intubation
16015784|NCT02769325|Drug|propofol|for anaesthesia induction, patients will receive 2-3 mg/kg iv propofol
16015785|NCT02769312|Device|Theta burst stimulation|Theta burst transcranial magnetic stimulation
16015786|NCT02769312|Device|Sham stimulation|Sham Theta burst transcranial magnetic stimulation
16015787|NCT02769299|Radiation|Radiation Therapy|less than 1 Gy with protons to 4-8 Gy with photons
16015788|NCT02769286|Drug|Osimertinib|Treatment efficacy of osimertinib will be assessed in patients with lung cancer harboring EGFR mutations (cohort 1) and those harboring T790M (cohort 2) which were detected from circulating tumor DNA
16015790|NCT02769260|Other|Toothbrushing|Normal toothbrushing without toothpaste or antiseptic mouthwash.
16015791|NCT02769247|Drug|Naproxen|Oral naproxen vs placebo
16015792|NCT02769247|Drug|Lidocaine|Intrauterine lidocaine vs normal saline
16015793|NCT02769247|Drug|placebo|either normal saline or empty oral capsule
16015794|NCT02769234|Procedure|ERP/EEG test|The testing protocol consists of an auditory oddball ERP paradigm, followed by the collection of 3min of resting EEG. During the ERP paradigm a variety of auditory stimuli are played through the system's earphones while voltage potentials are recorded from the subject's scalp. At the end of the ERP session, 3 minutes of EEG data will be recorded while the subject is resting. The entire procedure, including set up, instructions to the subject and actual test is expected to take 45-60 minutes.
16015795|NCT02769234|Procedure|Psychometric testing|Subjects that complete ERP/qEEG testing successfully will move on to clinical and neuropsychological evaluation. Demographic information with also be collected.
16015796|NCT02769221|Device|Rigid video stylet|
16015797|NCT02769221|Device|Video laryngoscope|
16015798|NCT02769208|Device|Central air handling unit air purification technologies|As described in the arm descriptions, the interventions involve changing the baseline pre-filter + HEPA + ESP conditions by removing either just the ESP or both the ESP and the HEPA for a five week period.
16015799|NCT02769182|Device|Monitoring and training using the system|subjects and caregivers will be trained on using the system and receive a 'user manual' delineating all procedures and possible applications of the system, as well as operations for daily charging of the sensors and smart phone. They will then be fitted with the sensors. The clinician will set all necessary applications, including setting the cognitive games application and the 'network of users'. Users and care givers will be informed of the personalized recommendations system that will provide the user with daily feedback on activity and weekly recommendations and goals for duration of the study. A helpline will be provided in case technological problems occur or for routine support.
16015800|NCT02769182|Behavioral|Standard of care|Subjects in this group will not receive the system but will encouraged to continue with their daily living routine and provided with recommendations for stretching and strengthening exercises. The control group subjects will be assessed at the same three time points as those in the experimental group. Subjects in both groups will also receive written information about the importance of activity, cognitive enhancing tasks, avoidance of falls and home hazards. In Israel, this information combined with an exercise prescription is considered the 'standard of care' for community-dwelling older adults.
16015801|NCT02769169|Drug|Lucentis® (Raibizumab) double-dose|Give patients 1 injection per month at the beginning 3 months. Give patients additional injection as needed. One injection contains 1mg of Lucentis® (Raibizumab). Intervention 'double-dose: Ranibizumab 1mg, 3 injection plus prn' has not been included in any Arm/Group Descriptions.
16015802|NCT02769169|Drug|Lucentis® (Raibizumab) regular-dose|Give patients 1 injection per month at the beginning 3 months. Give patients additional injection as needed. One injection contains 0.5mg of Lucentis® (Raibizumab). regular-dose: Ranibizumab 0.5mg, 3 injection plus prn
16015803|NCT02769143|Other|Whole-Body Vibration|Will be performed six months of WBV exercises
16015804|NCT02769143|Other|Pilates|Will be performed six months of Pilates exercises
16015805|NCT02769130|Drug|Losartan|Losartan is given for 12 months
16015806|NCT02769117|Procedure|Ultrasound on fractured bone|A new ultrasound technique for children and adults who have sustained forearm or clavicle fractures
16015807|NCT02769117|Procedure|Ultrasound on contralateral intact bone|A new ultrasound technique for the intact bone as the control for children and adults who have sustained forearm or clavicle fractures
16015808|NCT02769104|Drug|Letrozole (Aromatase Inhibitors)|Letrozole (Aromatase Inhibitors) for 5 years
16015809|NCT02769104|Drug|AC*4-T*4|CTX800mg/m2 d1+Anthracyclines75mg/m2 d1, every 3 weeks*4 cycles, be sequential with Docetaxel 75mg/m2 d1, every 3 weeks*4cycles
16015810|NCT02769091|Drug|TEV-45478|80 mg (2x40mg) tablets once daily for up to 24 weeks
16015811|NCT02769091|Drug|Placebo|
16015812|NCT02769078|Drug|dabigatran|
16015813|NCT02769078|Drug|rivaroxaban|
16015814|NCT02769078|Drug|apixaban|
16015815|NCT02769078|Drug|warfarin|
16015816|NCT02769065|Drug|TAK-071|TAK-071 capsules
16015817|NCT02769065|Drug|Donepezil|Donepezil over-encapsulated tablet
16015818|NCT02769065|Drug|TAK-071 Placebo|TAK-071 placebo-matching capsules
16015819|NCT02769065|Drug|Donepezil Placebo|Donepezil placebo-matching over-encapsulated tablet
16015820|NCT02769052|Device|Transcutaneous Electrical Nerve Stimulation (TENS)|Electrotherapy through self-applied device .
16015821|NCT02769039|Other|No intervention. Observational studies of sleep, movement and brain imaging|Participants will be asked to visit the University for 3 baseline visits which include a screening visit & sleep study, movement tests and magnetic resonance imaging (MRI) scans. Three years later the participant will be asked to repeat the same visits.
16015822|NCT02769013|Other|Pre-treatment follow up|No active intervention; medical support provided if needed
16015823|NCT02769013|Other|S. haematobium treatment|Praziquantel-treatment for S. haematobium positive volunteers
16015824|NCT02769013|Other|Post treatment follow up|No active intervention; medical support provided if needed.
16015825|NCT02769013|Other|Olfactometer experiment|No active intervention; medical support provided if needed.
16015826|NCT02769000|Radiation|10 GY in 5 daily fractions|Subjects 1-15 10 GY in 5 daily fractions
16015827|NCT02769000|Radiation|20 GY in 10 daily fractions|Subjects 16-30 20 GY in 10 daily fractions
16015828|NCT02768987|Behavioral|Bright 1 Bodies|A 12-week intensive lifestyle program utilizing group exercise classes adapted for this population, supplemented with coping skills training and diabetes self-management education.
16015829|NCT02768974|Drug|OPRX-106|Oral delivery, once daily.
16015830|NCT02768961|Drug|sofosbuvir|"Subjects will be treated according to the current guidelines on HCV treatment taking into account the stage of fibrosis, genotype, previous treatments, etc.
~Sofosbuvir will be used in association with ledipasvir. In some cases, ribavirin can be added to this combination according to current guidelines"
16015831|NCT02768961|Drug|ledipasvir|"Subjects will be treated according to the current guidelines on HCV treatment taking into account the stage of fibrosis, genotype, previous treatments, etc.
~Ledipasvir will be used in association with sofosbuvir. In some cases, ribavirin can be added to this combination according to current guidelines"
16015832|NCT02768948|Drug|telmisartan during 6 months|telmisartan during 6 months
16015833|NCT02768948|Drug|Losartan during 6 months|Losartan during 6 months
16015834|NCT02768948|Procedure|blood sample|blood sample
16015835|NCT02768935|Procedure|blood sample|blodd sample at 12 months
16015836|NCT02768922|Other|Aphasia telerehabilitation|Speech and language therapy delivered by speech-language pathologist via computer and telemedicine
16015837|NCT02768922|Other|Standard face-to-face aphasia rehabilitation|Speech and language therapy delivered by speech-language pathologist face-to-face (treatment as usual)
16015838|NCT02768909|Device|E-Nose|1.They will be asked to perform a respiration for 5 minutes trough the E-Nose Device, with a nose clamp.
16015839|NCT02768909|Other|Survey & Physical Exam|2. Perform a oriented survey for risk factors and a complete physical exam.
16015840|NCT02768909|Other|Chest X-ray|Perform anteroposterior chest X-ray
16015841|NCT02768909|Other|Sputum Samples|Sputum samples for Ziehl Neelsen smear and Culture in L-J.
16015842|NCT02768909|Device|Follow Up 5 days after beginning of Tx.|"Patients will be asked to come 5 days after initiation of treatment, to perform another measurement with the device.
~Also will perform a Medical History, including Symptom based Survey, Physical Exam, Anthropometric measurement, to determine progress of treatment."
16015843|NCT02768909|Device|Follow Up 15 days after beginning of Tx.|"Patients will be asked to come 15 days after initiation of treatment, to perform another measurement with the device.
~Also will perform a Medical History, including Symptom based Survey, Physical Exam, Anthropometric measurement, to determine progress of treatment."
16015844|NCT02768909|Device|Follow Up 30 days after beginning of Tx.|"Patients will be asked to come 30 days after initiation of treatment, to perform another measurement with the device.
~Also will perform a Medical History, including Symptom based Survey, Physical Exam, Anthropometric measurement, to determine progress of treatment."
16015845|NCT02768909|Device|Follow Up 60 days after beginning of Tx.|"Patients will be asked to come 60 days after initiation of treatment, to perform another measurement with the device.
~Also will perform a Medical History, including Symptom based Survey, Physical Exam, Anthropometric measurement, to determine progress of treatment."
16015846|NCT02768896|Behavioral|Baseline|Patients will walk naturally with EEG measuring brain waves
16015847|NCT02768896|Behavioral|visual stimuli|Patients will walk naturally with EEG measuring brain waves while seeing a grid through glasses
16015848|NCT02768896|Behavioral|Auditory stimuli|Patients will walk naturally with EEG measuring brain waves while hearing an auditory stimuli
16015849|NCT02768896|Behavioral|Visual and auditory stimuli|Patients will walk naturally with EEG measuring brain waves while seeing a grid through glasses and hearing an auditory stimuli simultaneously
16015850|NCT02768883|Behavioral|Respira Sano|The intervention is all three components: clinic + home + community.
16015851|NCT02768870|Device|Harpoon Artificial ePTFE Chords|It is anticipated that use of the Harpoon device could achieve similar outcomes to open cardiac surgery while decreasing the invasiveness of mitral valve repair.
16015852|NCT02768857|Behavioral|Sensorimotor reeducation programs|
16015853|NCT02768844|Device|Stochastic Vibrotactile Stimulation (SVS)|The infant's isolette mattress will be replaced with a specially designed mattress (non-commercially available; designed by Wyss Institute, Harvard University, Cofab Design LLC) to provide gentle vibrations and sounds during mattress stimulations.
16015854|NCT02768844|Other|Control|Absence of mattress Stochastic Vibratory Stimulation (SVS)
16015855|NCT02768831|Other|CPAP|Sealing the airway by holding CPAP of 20 cmH2O in the anesthesia circuit and slowly inflating the cuff until no air leak is heard with a stethoscope placed in the suprasternal notch.
16015856|NCT02768831|Other|Tidal volume|The ratio of the inspired to expired tidal volume will be determined using the following formula: (TVinspired - TV¬expired)/TVinspired. The peak inflating pressure (PIP) required to achieve the set TV will be noted. The air in the cuff will then be increased or decreased as needed to achieve a set delivered ratio of 0.9-1.0.
16015857|NCT02768818|Dietary Supplement|Probiotic VIVOMIXX™|The patients will be randomly assigned to the VIVOMIXX™ (intervention) or the control (placebo) group through a randomization list elaborated by a specific software.
16015858|NCT02768818|Dietary Supplement|Placebo|The patients will be randomly assigned to the VIVOMIXX™ (intervention) or the control (placebo) group through a randomization list elaborated by a specific software.
16015859|NCT02768805|Biological|15 µg/strain of Quadrivalent VLP Vaccine|Single dose of non-adjuvanted Quadrivalent VLP Vaccine
16015860|NCT02768805|Biological|30 µg/strain of Quadrivalent VLP Vaccine|Single dose of non-adjuvanted Quadrivalent VLP Vaccine
16015861|NCT02768805|Biological|15 µg/strain of the licensed quadrivalent vaccine|Single dose of the licensed quadrivalent vaccine
16015971|NCT02767947|Drug|Luliconazole Cream 1%|Luliconazole cream will be applied per schedule specified in the arm.
16015972|NCT02767947|Drug|Vehicle Cream|Vehicle cream will be applied per schedule specified in the arm.
16086862|NCT02258906|Drug|ulinastatin|
16015862|NCT02768792|Drug|pembrolizumab,|Pembrolizumab 200 mg is administered IV once as monotherapy, 14 days after the initiation of HiDAC salvage induction chemotherapy. Patients who have a response (i.e., PR/CR/CRi) to induction phase will receive maintenance pembrolizumab at 200 mg IV every 3 weeks for up to 2 years of maintenance therapy (i.e., beginning on day 1 of maintenance).
16015863|NCT02768779|Other|Hair analysis|Within the laboratory, experimental factors controlling IR-MALDESI response to key ARVs representing various drug classes will be systematically evaluated using the design of experiments (DOE) statistical approach (41,127) for an unbiased optimization of IRMALDESI response to each of the ARVs and their major metabolites. The goal will be to achieve a lower limit of quantification (LLOQ) below clinically relevant hair strand concentrations.
16015864|NCT02768766|Drug|Selumetinib|"100mg, 125mg, 150mg, 175mg, 200mg or 225mg of oral capsules
~An orally active, small molecule with potential antineoplastic activity. Selumetinib is an ATP-independent inhibitor of mitogen-activated protein kinase kinase (MEK) or MAPK/extracellular-signal-regulated kinase (ERK) kinase) 1 and 2. Inhibition of both MEK1 and 2 by selumetinib prevents the activation of MEK1/2 dependent effector proteins and transcription factors, thereby leading to an inhibition of cellular proliferation in various cancers."
16015865|NCT02768753|Procedure|The Axillary Bilateral-breast Approach|
16015866|NCT02768753|Procedure|The bilateral Axillo-breast Approach|
16015867|NCT02768740|Drug|Hydrocortisone hemisuccinate|In the 200-mg group, patients received an intravenous bolus of 50 mg of hydrocortisone every six hours for seven days associated with a continuous infusion of placebo for five days. In the 300-mg group, patients received an initial bolus of 100 mg of hydrocortisone followed by a continuous infusion of 300 mg per day for five days associated with a bolus of placebo every six hours for seven days.
16015868|NCT02768727|Drug|Xenon|drug given in concentrations of 0% to 60% over period of 2 hours
16015869|NCT02768714|Drug|Eurofarma's pegfilgrastim|Eurofarma's pegfilgrastim is a clear, colourless solution for injection (6 mg/0.6 mL) provided in a single use prefilled syringe. Subjects randomised to Eurofarma's pegfilgrastim will receive 6 mg administered as a single SC injection in the abdomen, upper arm, or thigh on Day 2 of each CTX cycle, approximately 24 hours after
16015870|NCT02768714|Drug|Neulastim|Eurofarma's pegfilgrastim is a clear, colourless solution for injection (6 mg/0.6 mL) provided in a single use prefilled syringe. Subjects randomised to Eurofarma's pegfilgrastim will receive 6 mg administered as a single SC injection in the abdomen, upper arm, or thigh on Day 2 of each CTX cycle, approximately 24 hours after
16015873|NCT02768688|Other|Brain connectivity and physiology|MRI to measure glymphactic flow during simulated natural sleep and again on return to wakefulness.
16015874|NCT02768688|Drug|Dexmedetomidine|Administering of 0.5-1.0 mcg/kg/hr of dexmedetomidine to ensure subject's loss of consciousness.
16015875|NCT02768675|Device|LOADPRO|The Intellirod LOADPRO sensor is a single-use, disposable instrument for the intra-operative measurement of posterior instrumented, spine rod strain.
16015876|NCT02768662|Drug|OTO-104|Single intratympanic injection of 12 mg OTO-104
16015877|NCT02768649|Drug|RBP-7000|Sequential dosing of each cohort
16015878|NCT02768649|Drug|risperidone|All eligible subjects received a test dose of risperidone to ensure tolerability prior to dosing with RBP-7000.
16015879|NCT02768636|Dietary Supplement|Omega-3|Omega-3 or Fish oil (1000 mg.) is taken for one capsule a day in 30 days duration. Heart rate variability is tested before at starting day and later follow up it again in the next 30 days appointment.
16015880|NCT02768623|Other|Pharmacist led Asthma Management|
16015881|NCT02768623|Other|Pharmacist Intervention (when requested by patient)|
16015882|NCT02768610|Drug|Dexmedetomidine|
16015883|NCT02768610|Drug|Normal Saline|
16015884|NCT02768597|Device|ReUnion System with a Large-Diameter Glenosphere +2 mm offset|Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +2 mm offset
16015885|NCT02768597|Device|ReUnion System with a Small-Diameter Glenosphere +2 mm offset|Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +2 mm offset
16015886|NCT02768597|Device|ReUnion System with a Large-Diameter Glenosphere +6 mm offset|Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Large-Diameter Glenosphere +6 mm offset
16015887|NCT02768597|Device|ReUnion System with a Small-Diameter Glenosphere +6 mm offset|Primary Reverse Shoulder Arthroplasty using the ReUnion System with a Small-Diameter Glenosphere +6 mm offset
16015888|NCT02768571|Drug|Cerebrolysin|Cerebrolysin- cerebrolysin 30 ml with 100 ml dilution/day * 21 days with rehabilitation
16015889|NCT02768571|Drug|Placebo|Placebo- saline 100 ml/day * 21 days with rehabilitation
16015890|NCT02768558|Radiation|Radiation Therapy (RT)|2 Gy fractions once a day, 5 days per week, for a total of 60 Gy in 30 fractions.
16015891|NCT02768558|Drug|Cisplatin|Concurrently with radiation therapy, 50 mg/m2, IV, on days 1, 8, 29, and 36, to begin with day 1 of radiation therapy.
16015892|NCT02768558|Drug|Etoposide|Concurrently with radiation, 40 mg/m2, IV, on days 1-5 and 29-33, to begin with day 1 of radiation therapy.
16015893|NCT02768558|Drug|Nivolumab|Beginning 4-12 weeks after chemoradiation, 240 mg, IV, every 2 weeks for 16 weeks, then 480 mg, IV, for 36 weeks.
16015894|NCT02768558|Other|Placebo|Beginning 4-12 weeks after chemoradiation, 240 mg, IV, every 2 weeks for 16 weeks, then 480 mg, IV, for 36 weeks.
16015895|NCT02768545|Drug|Ezetimibe|Ezetimibe 10 mg per day before and after transplant
16015896|NCT02768532|Drug|Vedolizumab|"During each 8 visits (screening, V0, V1, V2, V3, V4, V5, V6) at weeks-1, 0, 2, 6, 10, 14, 22, 54, respectively), the following parameters will be systematically recorded: Crohn's disease Activity Index (CDAI), adverse events.
~Blood and fecal samples will be systematically collected at weeks 0, 2, 6, 10, 14, 22 and 54 for routine serum ultrasensitive CRP (C-Reactive Protein) and fecal calprotectin assessments and for vedolizumab pharmacokinetic parameters, including the vedolizumab trough levels and the specific anti-Vedolizumab antibodies. In case of loss of response, an additional measurement of serum CRP (C-Reactive Protein), fecal calprotectin and Vedolizumab pharmacologic parameters will be performed."
16015897|NCT02768519|Drug|OTS167IV|diluted to final concentration with cherry syrup
16015898|NCT02768519|Other|Cherry syrup|
16015899|NCT02768493|Drug|1.0 ml/kg of 0.15% ropivacaine|Randomly selected patients of the high dose group are given 1.5 ml/kg of 0.15% ropivacaine for caudal block before their surgery. In contrast, patients in the low dose group are given 1.0 ml/kg of 0.15% ropivacaine for caudal block before surgery.
16015900|NCT02768493|Drug|1.5 ml/kg of 0.15% ropivacaine|Randomly selected patients of the high dose group are given 1.5 ml/kg of 0.15% ropivacaine for caudal block before their surgery. In contrast, patients in the low dose group are given 1.0 ml/kg of 0.15% ropivacaine for caudal block before surgery.
16015901|NCT02768480|Other|Primary Care|Patients will be followed by primary care team according to the usual health system routine.
16015902|NCT02768480|Other|Phone Calls Support and Primary Care|Patients in intervention group will receive periodic phone calls (every three months) and will have a toll-free number to resolve questions about the disease management. The phone-calls will be performed by trained nurses and will follow a structured format. Nurses will address some topics: patient's treatment adherence, technique of insulin administration, disease understanding, hypoglycaemia management, healthy diet, smoke cessation and foot care.
16015903|NCT02768467|Procedure|Tissue Matrix Graft Placement|Subject will receive a covering for the wound post buccal mucosa removal.
16015904|NCT02768467|Procedure|No Stitches|Subject will not receive stitches post buccal mucosa removal.
16015905|NCT02768454|Drug|medical review of controlled broad-spectrum antibiotics|medical review of outcome of antibiotics stewardship by pharmacists and infectious disease physicians
16015906|NCT02768441|Drug|Dexamphetamine|Participants will receive 60 mg Dexamphetamine SR daily for 5 consecutive days
16015907|NCT02768428|Other|Video-Audio Media|each arm spends 15 mins for watching the video or study the handbooks
16015908|NCT02768415|Drug|Apatinib|
16015909|NCT02768415|Drug|Oral Vinorelbine|
16015910|NCT02768402|Device|Caisson TMVR System|Transcatheter mitral valve replacement is a percutaneous procedure used to treat mitral valve regurgitation with a prosthetic valve implantation.
16015911|NCT02768389|Drug|Bevacizumab|Subjects receive Bevacizumab as standard of care
16015912|NCT02768389|Behavioral|Modified Atkins Diet|The modified Atkins diet (MAD) includes high fat, unlimited protein, and restricted carbohydrates (< 20gm/day).
16015913|NCT02768376|Drug|Bupivacaine with Fentanyl (Spinal Anesthesia)|Intrathecal injection of 15 mg Bupivacaine 0.5% at L 2-3 level mixed with 20 µ Fentanyl. Patients head will be lowered till sensory level of T 6 is abstained.
16015914|NCT02768376|Drug|General anesthesia|Induction by propofl 1.5-2 mg/kg, Fentanyl 1-2 mic/kg and atracrium 0.5 mg/kg Then maintained using Sevoflurane based anesthesia aiming to maintain Bispectral index 40-60..
16015915|NCT02768363|Biological|aglatimagene besadenovec|Aglatimagene besadenovec will be delivered to the prostate via trans-rectal ultrasound guided injection followed by 14 days of oral prodrug, valacyclovir. The second aglatimagene besadenovec injection will be 2-3 weeks after the first followed by 14 days of valacyclovir.
16015916|NCT02768363|Biological|placebo|Placebo will be delivered to the prostate via trans-rectal ultrasound guided injection followed by 14 days of oral prodrug, valacyclovir. The second placebo injection will be 2-3 weeks after the first followed by 14 days of valacyclovir.
16015917|NCT02768363|Drug|valacyclovir|Oral prodrug to be given for 14 days starting the day after each aglatimagene besadenovec or placebo injection.
16015918|NCT02768350|Procedure|Ventilator hyperinflation technique|"Hyperinflation using a ventilator or ventilator hyperinflation technique (VHI) was developed from the manual hyperinflation (MHI) technique. There is no need to disconnect the patient when using the VHI technique and consequently there is no loss of PEEP and little or no risk of the adverse effects associated with MHI."
16015919|NCT02768350|Procedure|Conventional treatment|Conventional treatments are the routine treatment that patients were received from the physical therapist who take care them. The routine treatments are consist of chest physical therapy techniques (i.e. vibration, positioning, etc.) and others treatment (i.e. passive movement).
16015920|NCT02768337|Drug|Afatinib|
16015921|NCT02768337|Radiation|2 Gy targeted radiotherapy|
16015922|NCT02768337|Radiation|4 Gy targeted radiotherapy|
16015923|NCT02768311|Procedure|neolix rotary system (continuous rotation system)|Procedure: neolix rotary system
16015924|NCT02768311|Procedure|waveone rotary system (reciprocating system)|Procedure: waveone rotary system
16015925|NCT02768311|Procedure|hand files k-files|Procedure: hand files k-files
16015926|NCT02768298|Drug|LCZ696|LCZ696 100 mg bid for 2 weeks followed by LCZ696 200 mg bid for 10 weeks. Treatment was administered as oral tablets.
16015927|NCT02768298|Drug|Enalapril|"Enalapril 5 mg bid for 2 weeks followed by enalapril 10 mg bid for 10 weeks. Treatment was administered as oral tablets.
~Patients who prior Screening were at a stable daily dose of enalapril above 10 mg per day (or corresponding doses of other ACEI/ARB) started the study at a dose of enalapril 10 mg bid."
16015928|NCT02768298|Drug|Placebo matching enalapril|Patients randomized to LCZ696 arm also received placebo matching enalapril (enalapril 0 mg tablets) to ensure the blinding during the entire course of the study.
16015929|NCT02768298|Drug|Placebo matching LCZ696|Patients randomized to enalapril arm also received placebo matching LCZ696 (LCZ696 0 mg tablets) to ensure the blinding during the entire course of the study.
16015930|NCT02768285|Procedure|APICAL PATENCY|After determining the working length, a small and flexible size 10 K-file was inserted 1 mm beyond the WL.
16015931|NCT02768272|Device|PCEA vs PIEB|We evaluate the relation between the distribution of L-bupivacaine plus fentanyl in the epidural space and the incedence of breaktrough pain during labor
16015932|NCT02768272|Procedure|Epidural vs CSE|We evaluate the relation between the type of epidural technique and the incedence of breaktrough pain during labor
16015933|NCT02768246|Device|BVGA|The BVGA enables the direct connection of a bag valve device to a guedel, eliminating the need for a face mask during ventilation
16015934|NCT02768246|Device|Face Mask|Classic face mask
16015935|NCT02768233|Behavioral|Educational programme|The 6-session educational programme is based on theory of motivational interviewing, and patients can choose between individualized education or education in groups. The standard treatment consists of withdrawal and consultations by neurologist.
16015936|NCT02768220|Drug|empagliflozin|Test to see how 30 days of jardiance changes serum and urinary advanced glycation end product levels
16015937|NCT02768220|Drug|linagliptin|Test to see how 30 days of tradjenta changes serum and urinary advanced glycation end product levels
16015938|NCT02768207|Drug|Cobimetinib|Participants will receive cobimetinib 60 mg tablets (three 20 mg tablet) orally OD for 21 consecutive days (Days 1 to 21), followed by a 7 day break (Days 22 to 28); in each 28-day cycle of treatment phase until disease progression, consent withdrawal, or the development of unacceptable toxicity.
16015939|NCT02768207|Drug|Vemurafenib|Participants will receive vemurafenib 960 mg tablets (four 240 mg tablet) orally BID from Day 1 to Day 28 of each 28-day cycle of the treatment phase until disease progression, consent withdrawal, or the development of unacceptable toxicity.
16015940|NCT02768194|Device|Stannous fluoride|Dentifrice containing 0.454% stannous fluoride
16015941|NCT02768194|Other|Sodium monofluorophosphate|Dentifrice containing 0.76% sodium monofluorophosphate
16015942|NCT02768194|Other|Mineral water|Commercially available mineral water
16015943|NCT02768181|Behavioral|Nutrition-specific Behaviour change communication (BCC)|Door-to-door counseling on nutrition during pregnancy and exclusive breastfeeding from enrolment into study till birth; exclusive breastfeeding and nutrition of lactating mothers during post-natal 6 months; timely and appropriate complementary feeding with continued breastfeeding until 2 years of child's age, and nutrition of lactating mothers during post-natal 6-24 months; all counseling would be supplemented with associated issues including hygiene and sanitation, mother's sleep and rest, maternal and child healthcare seeking etc.
16015944|NCT02768181|Dietary Supplement|Nutrient supplement to pregnant women (PNS)|"A lipid-based micronutrient supplement (LNS) is packed in ~10g sachets. Formulation: Vegetable fat (soy), skimmed milk powder, peanuts, vitamin and mineral complex, sugar, stabilizer: fully hydrogenated vegetable fat, and antioxidant : tocopherols. Each sachet contains 70-75% of recommended dietary allowance for most of the micronutrients, including iron, folic acid, zinc, calcium, iodine, vitamins A, B1, B2, niacin, B12 etc.
~Dose: 1 sachet/pregnant woman/day starting from the first counseling session (GA ~125∓15 days) continued till birth of baby. Supplement should be taken with food in room temperature, and must not be heated, or mixed with hot food. To avoid overdose, respondents receiving this supplement should stop taking any other micronutrient supplement or drink."
16015945|NCT02768181|Dietary Supplement|Nutrienr supplement to children 6m to 2 years|"A lipid-based micronutrient supplement (LNS) is packed in ~10g sachets. Formulation: Vegetable fat, skimmed milk powder, peanuts, sugar, vitamin and mineral complex, maltodextrin, and emulsifier: lecithin. Each sachet contains 70-75% of recommended dietary allowance for most of the micronutrients, including iron, folic acid, zinc, calcium, iodine, vitamins A, B1, B2, niacin, B12 etc. Each 20 g of LNS provide ≥4.46g LA (Linoleic Acid) and ≥0.42g ALA (α-Linolenic Acid).
~Dose: 2 sachets ~(10+10=20g)/child/day from 5th completed months (181 days) to 24 completed months of child's age. Supplement should be taken with food in room temperature, and must not be heated, or mixed with hot food. Supplement should be taken with food in room temperature, and must not be heated, or mixed with hot food. To avoid overdose, respondents receiving this supplement should stop taking any other micronutrient supplement or drink."
16015946|NCT02768168|Drug|dezocine|receive dezocine 0.1 mg/kg
16015947|NCT02768168|Other|normal saline|receive matching placebo (equal volume of normal saline)
16015948|NCT02768155|Other|Amniotic Fluid 4.0ml dose|Injection of Amniotic Fluid
16015949|NCT02768155|Other|Amniotic Fluid 2.0ml dose|Injection of Amniotic Fluid
16015950|NCT02768155|Other|Placebo Control|Normal Saline
16015951|NCT02768142|Other|Natural cesarean delivery|Natural cesarean delivery
16015952|NCT02768142|Other|Standard cesarean delivery|Standard cesarean delivery
16015953|NCT02768129|Device|transcranial direct current stimulation|active stimulation: 2 milliamp (mA), 20 mins
16015954|NCT02768129|Device|sham transcranial direct current stimulation|sham stimulation
16015955|NCT02768116|Procedure|Sirolimus Drug-eluting Stent via Active Transfer of Plaque|
16015956|NCT02768116|Procedure|Sirolimus Drug-eluting Stent implantation via Provisional T Stenting|
16015957|NCT02768103|Behavioral|task-based training|The 10-week training program is designed to incorporate requirements of motor learning and includes activities that require learning to coordinate the transferred Br with other synergists by producing pinch force in different upper limb postures and in a range of pinch openings. Biofeedback using a pinch dynamometer in self-selected postures provides feedback and knowledge of progress to the participant. A task board is used for practicing task-specific activities such as opening and closing zippers, using a remote, an ATM card, a key, and an electrical plug and focuses on pinch in dynamic conditions that require modulating force and maintaining specific positions. The pinch-pin device requires closing pinch-pins (clothes pin) of variable resistance ranging from approximately 1 to 8 lbs and placing them on rods arranged at different positions in the work space.
16015958|NCT02768090|Device|Skin Patch|Sweat will be collected by applying a diagnostic skin patch to inflammatory and neoplastic cutaneous lesions for proteomic analysis with mass spectrometry.
16015959|NCT02768077|Drug|Melatonin(Circadin®)|
16015960|NCT02768077|Drug|Placebo|
16015961|NCT02768064|Device|temporary pacemaker insertion|Insertion of pacemaker electrode (Medtronic flow direct pacing catheter), connect to external pacemaker (Medtronic).
16015962|NCT02768051|Procedure|AF Ablation|
16015963|NCT02768038|Other|Observational|Blood, stool ja biopsy specimens
16015964|NCT02768025|Other|Traditional & Complementary Medicine treatment|Body acupuncture, Ear acupuncture and aromatic therapy
16015965|NCT02768025|Other|NRT, counselling|Nicotine Replacement Therapy, counselling
16015966|NCT02768012|Behavioral|mindfulness-based cognitive therapy|Six two-hour small group sessions (6-9 participants) will be administered over 8 weeks focusing on MBCT. The intervention follows a written protocol to ensure fidelity of delivery. Participants will receive detailed manuals summarizing session content and home assignments (HAs), including mindfulness practices, audio versions of which will be available on an internet link.
16015967|NCT02767999|Drug|Fluoxetine|20 mg of fluoxetine capsule per day from D0 to D90
16015968|NCT02767999|Drug|Placebo|cellulose placebo per day from D0 to D90
16015969|NCT02767999|Radiation|fMRI|functional resting state MRI
16015970|NCT02767973|Other|Wood Smoke Particles (WSP)|After baseline (pre-exposure) assessment (which includes recovery of induced sputum), these volunteers will then undergo an exposure to 500μg/m3 wood smoke particles for 2 hours, with alternating 15 min of exercise (cycle ergometer) with 15 min rest to achieve 25 l/m2 body surface/min minute ventilation, followed by sputum induction after 6 and 24 hours after initiation of the challenge.
16086863|NCT02258906|Drug|normal saline|
16015973|NCT02767934|Other|Laboratory Biomarker Analysis|Correlative studies
16015974|NCT02767934|Biological|Pembrolizumab|Given IV
16015975|NCT02767921|Other|Cytology Specimen Collection Procedure|Correlative studies
16015976|NCT02767921|Other|Laboratory Biomarker Analysis|Correlative studies
16015977|NCT02767921|Procedure|Radical Cystectomy|Undergo robotic-assisted radical cystectomy
16015978|NCT02767921|Biological|Recombinant EphB4-HSA Fusion Protein|Given IV
16015979|NCT02767921|Procedure|Therapeutic Conventional Surgery|Undergo robotic-assisted radical or partial nephrectomy
16015980|NCT02767908|Other|Intervention|Participants will receive a tailored support package which will include; Nicotine replacement products, behavioural support, including telephone support, Carbon dioxide measurements, home air quality measurements, signposting to support groups, and self-help materials.For participants who decline a home visit, the above support options will be offered as far as possible through telephone contact and delivered to the extent accepted by the participant. Those who report cessation at 4 weeks and/or three months will be requested to agree to a home visit for CO validation.
16015981|NCT02767895|Behavioral|Prehabilitation|Participants will receive an informational DVD, a pedometer, an incentive spirometer and access to the program website to help promote healthful behaviors and improved well-being in the days leading up to surgery.
16015982|NCT02767882|Drug|Dexamethasone|Bolus injection of different dose of dexamethasone will be given intravenously prior to incision.
16015983|NCT02767882|Drug|Saline|Bolus injection of 4ml 0.9% saline will be given intravenously prior to incision.
16015984|NCT02767869|Drug|Banaba|Banaba capsules of 500 mg two times per day before meals with a total dosis of 1000 mg per day.
16015985|NCT02767869|Drug|placebo|Calcined magnesia capsule, 500 mg, two times per day before meals with a total dose per day of 1000 mg
16015986|NCT02767856|Device|IO-therapy Glasses|
16015987|NCT02767843|Device|continuous negative external pressure (cNEP)|soft silicone collar placed on the anterior neck, to which a negative pressure is introduced
16015988|NCT02767830|Behavioral|Excercise and Nutrition Program|
16015989|NCT02767817|Procedure|Stereotactic Hematoma Evacuation|Stereotactic intracranial hematoma and insert the drainage tube to inhale haematoma. The drainage tube stayed in the position for 1-2 days until adequate drainage of hematomas, and then the drainage tube was pulled out.
16015990|NCT02767817|Biological|MSCs Transplantation|Stereotactic intracranial hematoma and insert the drainage tube to inhale haematoma. The drainage tube stayed in the position for 1-2 days until adequate drainage of hematomas,and 10 million MSCs were transplanted into the hematoma cavity before the drainage tube was pulled out.
16015991|NCT02767817|Biological|Injectable Collagen Scaffold with MSCs Transplantation|Stereotactic intracranial hematoma and insert the drainage tube to inhale haematoma. The drainage tube stayed in the position for 1-2 days until adequate drainage of hematomas, and injectable collagen scaffold combined with 10 million MSCs were transplanted into the hematoma cavity before the drainage tube was pulled out.
16015992|NCT02767804|Drug|X-396 (ensartinib)|oral ALK inhibitor
16015993|NCT02767804|Drug|crizotinib|oral ALK inhibitor
16015994|NCT02767791|Other|Acupuncture|Acupuncture
16015995|NCT02767791|Other|Auriculotherapy|Auriculotherapy
16015996|NCT02767778|Device|REAL Pulsed ELF-MF stimulation|Within 48 hours from the onset of the stroke, the enrolled patients will undergo to 120 min, daily, pulsed ELF-MF treatment for 5 consecutive days, during their hospital stay.Pulsed ELF-MF stimulation will be administrated by a rectangular, flexible coil, positioned upon the ischemic hemisphere and connected to the pulse generator (B-01; IGEA, Carpi, Italy) producing a single-pulsed signal at 75±2 Hz, with a pulse duration of 1.3 ms and a peak intensity of the magnetic field of 1.8±0.2 mT.
16015997|NCT02767778|Device|SHAM Pulsed ELF-MF stimulation|SHAM pulsed ELF-MF stimulation will be administrated by a rectangular, flexible coil, positioned upon the ischemic hemisphere and connected to the pulse generator (B-01; IGEA, Carpi, Italy). The device for SHAM stimulation is identical and produces the same auditory sensation of the device for REAL stimulation but the SHAM device has no stimulating effect on the brain.
16015998|NCT02767765|Drug|r-HuEPO|All participants will receive r-HuEPO for 4 weeks, at a dose of 10000 international units per day (IU/day) according to 6 days/week schedule for first 2 weeks and at a dose of 10000 IU/day according to 3 days/week schedule (participants with response to treatment at end of Week 2) or according to 6 days/week schedule (participants without response to treatment at end of Week 2) for next 2 weeks.
16015999|NCT02767752|Dietary Supplement|T-ChOS|
16016000|NCT02767752|Drug|Gemcitabine|
16016001|NCT02767752|Dietary Supplement|Placebo|
16016002|NCT02767752|Drug|Capecitabine|
16016003|NCT02767739|Behavioral|Physical, social and cultural activities|This intervention included two 60-min aerobic exercise sessions per week. Each session was supervised by a physical activity specialist and walking and stretching exercises were performed after programmed exercise sessions. PHC nurses were prepared to advise patients about the health benefits of PA and used different strategies to encourage the adherence of participants to the program. In addition, social and cultural support activities were included in this intervention program. These activities were performed once a month and they included: visits to museums and libraries, cultural exhibitions, tourist attractions and dance lessons.
16016004|NCT02767726|Device|non-invasive multimodal imaging|
16016005|NCT02767713|Drug|Dexamethasone|Intravenous dexamethasone (0.1 mg/kg) was administered 10 hours before surgery.
16016006|NCT02767713|Other|Placebo|Normal saline (placebo) in the equal volume as active treatment was administered 10 hours before surgery.
16016007|NCT02767700|Genetic|NGS|Next generation sequencing
16016008|NCT02767687|Other|Noninvasive ventilation|Twenty minutes after extubation all subjects will receive noninvasive ventilation delivered through a facial mask with an ICU ventilator with NIV option for 60 minutes. NIV associates pressure support ventilation (PSV: 5 to 15 cmH2O) and positive end expiratory pressure (PEEP: 5 to 10 cmH2O).
16016009|NCT02767674|Drug|Rituximab|375 mg/m2 IVD day0
16016010|NCT02767674|Drug|Gemcitabine|Gemcitabine 1 g/m2 IVD day 1
16016011|NCT02767674|Drug|Oxaliplatin|Oxaliplatin 100 mg/m2 IVD day1
16016012|NCT02767674|Drug|Cyclophosphamide|Cyclophosphamide 400 mg/m2 IVD d1
16016013|NCT02767674|Drug|Epirubicin Injectable Product|Epirubicin 35 mg/m2 IVD d1
16016014|NCT02767674|Drug|Vindesine|Vindesine 2 mg IVP d1
16016015|NCT02767674|Drug|Prednisone|Prednisone 40mg/m2 PO d1-5
16016016|NCT02767661|Drug|Capecitabine|Capecitabine, 625mg/m2, orally twice daily (continuously)
16016017|NCT02767661|Drug|Aromatase Inhibitor|Aromatase Inhibitor (Anastrozole, 1mg, orally once daily or Letrozole, 2.5mg, orally once daily or Exemestane , 25mg, orally once daily)
16016018|NCT02767648|Other|proteomic urine analysis|proteomic urine analysis
16016019|NCT02767635|Drug|Botox-Epic|injected 20 units of Botox into lateral epicondyle in Botox-Epic group
16016020|NCT02767635|Drug|Botox-Tend|injected 20 units of Botox into tender point of muscles in Botox-Tend group
16016021|NCT02767635|Drug|triamcinolone acetonide (Steroid)|injected 40mg of triamcinolone acetonide into lateral epicondyle in Steroid group
16016022|NCT02767622|Procedure|Liver transplantation|
16016023|NCT02767609|Device|Magnetic Resonance Imaging|All participants will have be given a MRI using a pseudo-continuous arterial spin labeling perfusion sequence.
16016024|NCT02767596|Drug|Lixisenatide|
16016025|NCT02767596|Drug|Basal insulins|patients are on basal insulin treatment
16016026|NCT02767583|Device|Exams|Patients the eligibility criteria will be proposed at the first consultation in central obesity, participate in a clinical study to assess the prevalence of subclinical damage peripheral nerves by simple and painless rapid measurement of skin conductance on the palm of the feet with the Sudoscan® device during the consultation and a Thermotest®, as well as monitoring during the various follow-up consultation after any bariatric surgery or not. This monitoring will be done by the same neurophysiological tests.
16016027|NCT02767570|Other|Gait Training; Altered Foot Progression Angle|Participants will receive personalized gait training while walking on a treadmill with real-time, haptic feedback to encourage them to adopt a new foot progression angle. Participants will walk for an additional ten minutes per day to internalize their new foot progression angle over 52 weeks.
16016028|NCT02767570|Other|Gait Training; Consistent Foot Progression Angle|Participants will receive personalized gait training while walking on a treadmill with haptic feedback to encourage them to maintain a consistent foot progression angle. Participants will walk an additional ten minutes per day to internalize the consistency of their foot progression angle over 52 weeks.
16016029|NCT02767557|Drug|Tocilizumab|Intravenous infusion
16016030|NCT02767557|Drug|Gemcitabine|Intravenous infusion
16016031|NCT02767557|Drug|nab-Paclitaxel|Intravenous infusion,
16016032|NCT02767544|Procedure|Vaginal wound local analgesia after laparoscopic hysterectomy|
16016033|NCT02767531|Drug|Orlistat|Orlistat is a gastric and pancreatic lipase inhibitor that is approved by the FDA for weight loss. It is available over-the-counter as 60 mg tablets under the trade name Alli, and available by prescription as 120 mg capsules under the trade name Xenical.
16016034|NCT02767518|Behavioral|Prehabilitation|Participants will receive an informational DVD, a pedometer, an incentive spirometer and access to the program website to help promote healthful behaviors and improved well-being in the days leading up to surgery.
16016035|NCT02767505|Other|gastric bypass|Type of surgery: gastric bypass
16016036|NCT02767505|Other|Sleeve gastrectomy|Typ of surgery: sleeve gastrectomy
16016037|NCT02767492|Device|BioD Restore|Investigational product, BioD Restore, will be injected into the articular space of the knee.
16016038|NCT02767492|Drug|Kenalog|Active comparator, Kenalog steroid, will be injected into the articular space of the knee.
16016039|NCT02767479|Drug|rabeprazole-based regimen|This group is treated with rabeprazole 10 mg bid, AMPC 750 mg bid and CAM 200 mg bid for 1 week. Success or Failure of eradication of H. pylori is assessed by 13C-UBT 1 month after the treatment.
16016040|NCT02767479|Drug|esomeprazole^based regimen|This group is treated with esomeprazole 20 mg bid , AMPC 750 mg bid and CAM 200 mg bid for 1 week. Success or Failure of eradication of H. pylori is assessed by 13C-UBT 1 month after the treatment.
16016041|NCT02767466|Procedure|Physical therapy and robotic assisted gait training|
16016042|NCT02767453|Procedure|Wound drainage|Experimental portion removing/draining blood/fluid from a space created during a surgical procedure. Typically, surgeons place a plastic tube in the shoulder joint to drain fluids that may accumulate after surgery. Hemovac drain is a FDA-approved device routinely used or wound drainage; however, there is no known evidence whether this improves outcomes of surgery.
16016043|NCT02767453|Procedure|Total Shoulder Arthroplasty|"Standard procedure for treating the severe pain and stiffness that often result at the end stage of various forms of arthritis or degenerative joint disease of the shoulder joint. The primary goal of shoulder replacement surgery is pain relief, with a secondary benefit of restoring motion, strength, function, and assisting with returning patients to an activity level as near to normal as possible. Shoulder prosthesis is a standard artificial device to replace both components of the ball and socket joint during TSA."
16016044|NCT02767440|Behavioral|Families on Track Intervention|Parents will receive the standard of care activities at the Healthy Lifestyles clinic at Duke University. They will also receive a modified version of the previously conducted Track intervention, a digital health weight loss intervention for adults in community health centers . The intervention will utilize the Interactive Obesity Treatment Approach (iOTA). iOTA uses a computer algorithm to assign 3 personalized behavioral goals known to create an energy deficit to produce weight loss (e.g., sugary drinks, fast food consumption walk 10,000 steps/day, etc). Participants will track these goals via interactive voice response (IVR) and text messaging technologies each week. They will receive immediate feedback based on self-monitoring data and skills training videos to learn how to make the behavioral changes necessary for weight loss. Intervention participants will also receive an analog bathroom scale and a pedometer to self-monitor daily weights and steps.
16016045|NCT02767427|Device|Chlorhexidine Wipes|(Standard of Care) Chlorhexidine wipes are a commonly used pre-operative skin cleansing measure, designed to reduce bacterial load on the skin of the surgical site.
16016046|NCT02767427|Other|No intervention|Chlorhexidine wipes will not be used though it is a commonly used pre-operative skin cleansing measure.
16016047|NCT02767414|Device|Respirio Flu Test|The Respirio Flu Test is a rapid in vitro diagnostic test for the detection of influenza A or influenza B in nasal secretions. The Respirio Flu Test is designed to be simple to use and generates a result within 20 minutes.
16016048|NCT02767414|Device|eLab Flu Test|The eLab Flu Test is an in vitro diagnostic test intended to be used at point-of-care for the detection of influenza A or influenza B in nasopharyngeal swab samples. The eLab Flu Test generates a result within 10 minutes.
16016049|NCT02767414|Device|Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)|Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) is a molecular diagnostic technique for the detection and identification of influenza viruses, both for clinical samples and isolates. The reverse transcriptase polymerase chain reaction (RT-PCR) allows template viral RNA to be reverse transcribed producing complementary DNA (cDNA) which can then be amplified and detected.
16016050|NCT02767401|Device|stenting or balloon expansion|all species of drug-eluting stent ((such as Xience, Endeavor, Taxus, Excel, Firebird) implantation or balloon expansion (POBA)
16016051|NCT02767401|Drug|aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc|Optimal medical therapy includes dual antiplatelet therapy and statins (aspirin, clopidogrel, ticagrelor, atorvastatin, rosuvastatin, betaloc). And optimal medical therapy should include adequate ventricular rate-limiting medication (i.e. Beta-blocker or rate-limiting calcium antagonist) where appropriate. Anti-anginal therapy should be used if the patients have symptom.
16016052|NCT02767375|Drug|Oxaliplatin(OXA), 5-fluorouracil (5-FU)|for the HAIC treatment group OXA 85mg/m2, d1，0-4h 5-FU 1500mg/m2 d1, 4-24h 24 hours in d1 & 2 , IA，q4-6 Weeks
16016053|NCT02767375|Procedure|Hepatic arterial catheter implantation|for the the HAIC treatment group: Hepatic arterial catheter implantation for HAIC
16016054|NCT02767362|Drug|Atorvastatin|Once enrolled on this pre-operative window study, patients with endometrial cancer will be treated with the standard clinical dose of atorvastatin (80 mg once daily orally) for an average of 2-4 weeks prior to surgical staging. Patients will need to be able to undergo atorvastatin treatment for a minimum of 2 weeks but no more than a maximum of 4 weeks prior to surgical staging.
16016055|NCT02767349|Drug|MNK-155|2 or 3 tablets initial dose, followed by two tablets every twelve hours
16016056|NCT02767336|Device|Blood Glucose Monitoring System.|In vitro diagnostic medical device
16016057|NCT02767323|Device|rTMS|excitatory 5Hz rTMS will be used
16016058|NCT02767323|Device|Sham rTMS|an electrical sham coil reproducing the same clicking sound and tactile sensation than the active rTMS will be used
16016059|NCT02767310|Drug|Rosuvastatin 20 mg film-coated tablets|Single oral dose of 20 mg
16016060|NCT02767310|Drug|Crestor 20 mg film-coated tablets|Single oral dose of 20 mg
16016061|NCT02767297|Drug|FDL169|
16016062|NCT02767284|Device|UCST-V1|A previously developed device, Uppsala Contrast Sensitivity Tester - UCST-V1, that quickly measures the human CSF in one stimulus.
16016063|NCT02767284|Device|UCST-V2|A refined version of the UCST-V1 that randomizes frequency order.
16016064|NCT02767284|Device|UCST-V3|A version that utilises eye-tracking technology to make the measurements more accurate.
16016065|NCT02767284|Device|Quick-CSF (QCSF)|A fast contrast sensitivity measurement method using a Bayesian algorithm.
16016066|NCT02767284|Device|Pelli-Robson|A standard method developed using a Sloan-letter chart with decreasing contrast.
16016067|NCT02767284|Device|Optec 6500|A standard test using sinusoidal gratings to measure the contrast sensitivity function.
16016068|NCT02767271|Drug|Luliconazole Cream 1%|Luliconazole cream will be applied topically per schedule specified in the arms.
16016069|NCT02767258|Device|LACRIBELL®|Hypromellose and dextran based eyedrop, used in the treatment of dry eye.
16016070|NCT02767258|Device|VIDISIC® GEL|Carbomer based gel, used in the treatment of dry eye.
16016071|NCT02767245|Drug|Thiamine|Thiamine IV 100 mg/day
16016072|NCT02767232|Drug|Recombinant tissue plasminogen activator (rt-PA)|Catheter-directed thrombolysis, consisting of intrathrombus administration of rt-PA using a catheter/device.
16016073|NCT02767232|Drug|Standard Anticoagulation Therapy|Standard anticoagulation determined by physician for a period of 3-6 months
16016074|NCT02767219|Drug|bevacizumab|Patients will be randomised to study arms with a 1:1 ratio. Once randomised, Group 2 will receive a subconjunctival injection of bevacizumab and a subconjunctival injection of dexamethasone 3.3mg/ml. This will be given for 4 consecutive weeks from time of entry into trial.
16016075|NCT02767219|Drug|5-fluorouracil|Patients will be randomised to study arms with a 1:1 ratio. Once randomised, Group 1 will receive a subconjunctival injection of 5-fluorouracil and a subconjunctival injection of dexamethasone 3.3mg/ml. This will be given as required for 4 consecutive weeks from time of entry into trial. This is current standard practice.
16016076|NCT02767219|Drug|Dexamethasone|Both intervention groups will be given a subconjunctival injection of dexamethasone at the time of injection of either bevacizumab or 5-fluorouracil
16016077|NCT02767193|Biological|DCV3|"Autologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded pulsed with autologous inactivated HIV virus.
~Patients will receive three immunizations of dendritic cells during weeks 0, 2 and 4"
16016078|NCT02767193|Biological|DCV3 with PEG-INF|Autologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded pulsed with autologous inactivated HIV virus with PEG_INF Patients will receive three immunizations of dendritic cells during weeks 0, 2 and 4 and INF during weeks 4,5 and 6
16016079|NCT02767193|Biological|Placebo|Autologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded Patients will receive three immunizations saline + 1% albumin during weeks 0, 2 and 4
16016080|NCT02767193|Biological|Placebo with PEG-INF|Autologous differentiated adult dendritic cells from monocytes of peripheral blood non expanded with PEG_INF Patients will receive three immunizations saline + 1% albumin during weeks 0, 2 and 4 and INF during weeks 4,5 and 6.
16016081|NCT02767167|Other|Semi-skimmed cow's milk|430ml of semi-skimmed cow's milk / day for 12 weeks
16016082|NCT02767154|Device|A colloid Dextran 40 solution for extracorporeal circulation|The oncotic pressure of the PrimECC solution is higher than that of a crystalloid Ringer-acetate/mannitol solution. It should maintain the plasma oncotic pressure during and after cardiopulmonary bypass (CPB). Subsequently, the leakage of fluids from the systemic circulation to the interstitial compartment during CPB can be reduced, and a higher plasma volume and a better fluid balance can be achieved.
16016083|NCT02767154|Device|Ringer-Acetate and Mannitol|Currently clinic standard for priming the CPB circuit.
16016084|NCT02767141|Behavioral|Coping Strategies|Coping strategies for households in the US with food insecurity
16016085|NCT02767128|Drug|Triferic|
16016086|NCT02767128|Drug|Fer-In-Sol|
16016087|NCT02767128|Drug|Shohl's solution|
16016088|NCT02767115|Dietary Supplement|2% GSE mucoadhesive gel|2% GSE mucoadhesive gel administered in periodontal pockets of GSE group at T0 and 3, 6, and 9 days after T0
16016089|NCT02767115|Other|GSE free mucoadhesive gel|GSE free mucoadhesive gel administered in periodontal pockets of Control group at T0 and 3, 6, and 9 days after T0
16016090|NCT02767102|Other|Red wine with melatonin|Twelve healthy volunteers will be recruited to receive both 125 mL of red wine rich in MLT (10 ng mL-1)
16016091|NCT02767102|Other|Red wine without melatonin|Twelve healthy volunteers will be recruited to receive both 125 mL of red wine without MLT
16016092|NCT02767089|Drug|Prednisone|Subjects will receive oral prednisone and/or placebo tablets (total of 4 tablets) to achieve the required dose according to the treatment sequence group they were randomized. Subjects are to be dosed each morning for 7 days. A 14 day washout period is required between each period. Prednisone was supplied in the 2.5 and 20 mg dosage strengths.
16016093|NCT02767089|Drug|Placebo|Placebo tablets similar to Prednisone 2.5 mg and 20 mg were supplied to make the trial doses.
16016094|NCT02767076|Procedure|conventional paramedian spinal anesthesia|land mark guided paramedian spinal anesthesia
16016095|NCT02767076|Device|ultrasound guided paramedian spinal anesthesia|real time ultrasound guided paramedian spinal anesthesia
16016096|NCT02767063|Drug|Pioglitazone|PIOGLITAZONE (Actos®): 30 mg per day for 12 months. The dose will be increased to 45 mg per day after 2 months in the absence of grade >1 related AE.
16016097|NCT02767063|Drug|Avelumab|10mg/kg every 2 weeks, for a maximum of 8 IV infusions over a 4 months' period. (If MR4.5 is acheived by the first 3 months the 7th and 8th infusions will be omitted)
16016098|NCT02767037|Device|Sudoscan and clinical assessment|The primary variable will be electrochemical skin conductance (ESC), as assessed by the SudoScan (Impeto Medical, France). The clinical assessment will include a neurological evaluation (including MDS-UPDRS), evaluation of autonomic symptoms and signs, EKG, evaluation of possible neuropathy and evaluation of non-motor variables.
16016099|NCT02767037|Genetic|Skin biopsy|Evaluation of the denervation and synuclein deposition of skin biopsy
16016100|NCT02767024|Drug|Sodium nitroprusside|Sodium nitroprusside is a medication used to lower blood pressure.
16016101|NCT02767024|Drug|Dobutamine|Dobutamine is a direct-acting inotropic agent whose primary activity results from stimulation of the ÃŸ receptors of the heart while producing comparatively mild chronotropic, hypertensive, arrhythmogenic, and vasodilative effects.
16016102|NCT02767024|Drug|Furosemide|Furosemide is a prescription drug used to treat hypertension (high blood pressure) and edema. Learn about side effects, warnings, dosage, and more.
16016103|NCT02767011|Other|Tele-Health Electronic Monitoring (THEM)|Patients in the intervention group (THEM) will receive a tablet computer and home monitoring medical devices with sensors to transmit the information to a central website that will be monitored by care managers. Medical devices will include weight scales, blood pressure cuffs and blood glucometers. Clinical care mangers will remotely monitor the patients and all electronic readings. Clinical care managers will call or send text messages to the patients based on alerts generated by the tele-health monitoring system.
16016104|NCT02766998|Procedure|Preserved umbilical vein as shunt/conduit|All subjects will have umbilical vein harvested and stored for use in first cardiac surgery requiring shunt or conduit.
16016105|NCT02766972|Procedure|Rapid Ventricular Pacing|Use of Rapid Ventricular Pacing to improve surgical clipping of intracranial aneurysms
16016106|NCT02766959|Other|Observational study|
16016107|NCT02766946|Device|Ultrasound|An ultrasound of the right diaphragm will be performed on day 1, day 3, day 5 and day 10
16016108|NCT02766946|Device|Ultrasound|An ultrasound of the pectoral muscle will be performed on day 1, day 3, day 5 and day 10
16016109|NCT02766946|Other|Neuromyopathy score|A neuromyopathy score will be assessed on the extubation day
16016110|NCT02766946|Other|Respiratory performances|An assessment of the respiratory performances will be done on the extubation day, including higher expiratory pressure, higher inspiratory pressure, and occlusion pressure
16016111|NCT02766907|Device|cryopreserved amniotic membrane|placement of cryopreserved amniotic membrane after routine debridement procedure for EBMD
16016112|NCT02766894|Device|EEG monitoring|EEG will be performed. Data obtained will be analyzed using software. Anesthesiologists will enter their assumption in a blinded fashion and data obtained will be compared with EEG data
16016113|NCT02766868|Drug|FACE-Flu/Bu/Cy|Chemotherapy with Fludarabine+cytarabine+cyclophosphamide+etoposie followed by conditioning regimen with Fludarabine, busulfan and Cyclophosphamide
16016114|NCT02766855|Drug|Cysteamine|Patients were asked to use topical cysteamine 0.55% eye drops every 2 hours while awake to both eyes.
16016115|NCT02766842|Procedure|EUS-FNB with ProCore needle|The use of the standard ProCore needle to acquire diagnostic tissue
16016116|NCT02766842|Procedure|EUS-FNB with SharkCore needle|The use of new SharkCore needle to acquire diagnostic tissue
16016117|NCT02766842|Device|ProCore needle|This is the standard needle used currently to procure tissue from lesions under endoscopic ultrasound guidance
16016118|NCT02766842|Device|SharkCore needle|This is the new FDA approved needle for tissue procurement under endoscopic ultrasound guidance.
16016119|NCT02766829|Procedure|Cross leg sitting position|Subjects were set on cross leg sitting position before spinal anesthesia begun.
16016120|NCT02766829|Procedure|Traditional sitting position|Subjects were set on traditional sitting position before spinal anesthesia begun.
16016121|NCT02766816|Biological|Part 1 study - BBio bOPV|A single dose of 2 drops (0.1 ml) orally of BBio bOPV to 20 children 60 to 83 months of age.
16016122|NCT02766816|Biological|Part 2 study - BBio bOPV Lot 1|Three doses of 2 drops (0.1 ml) orally of BBio bOPV Lot 1 to 270 infants at 6-8, 10-12 and 14-16 weeks of age.
16016123|NCT02766816|Biological|Part 2 study - BBio bOPV Lot 2|Three doses of 2 drops (0.1 ml) orally of BBio bOPV Lot 2 to 270 infants at 6-8, 10-12 and 14-16 weeks of age.
16016124|NCT02766816|Biological|Part 2 study - BBio bOPV Lot 3|Three doses of 2 drops (0.1 ml) orally of BBio bOPV Lot 3 to 270 infants at 6-8, 10-12 and 14-16 weeks of age.
16016125|NCT02766816|Biological|Part 2 study - Licensed bOPV|Three doses of 2 drops (0.1 ml) orally of a licensed bOPV to 270 infants at 6-8, 10-12 and 14-16 weeks of age.
16016126|NCT02766816|Biological|Part 1 study - Licensed bOPV|A single dose of 2 drops (0.1 ml) orally of a licensed bOPV to 20 children 60 to 83 months of age.
16016127|NCT02766803|Drug|Simvastatin and micronized trans-resveratrol|
16016128|NCT02766790|Dietary Supplement|TA-65MD|TA-65, a purified small molecule extracted from Astragalus root
16016129|NCT02766790|Other|Placebo|Placebo, an inactive formulation
16016130|NCT02766777|Drug|Lubiprostone|12 or 24 mcg soft capsules for oral administration.
16016131|NCT02766764|Drug|DHEA|Women will receive oral DHEA 25 mg t.d.s. for 12 weeks before ICSI.
16016132|NCT02766764|Drug|Growth hormone|Women will receive GH subcutaneous injections daily from day 6 of hMG administration until the day of hCG administration.
16016133|NCT02766764|Drug|Placebo 1|Women will receive an oral placebo similar to DHEA t.d.s for 12 weeks before ICSI
16016134|NCT02766764|Drug|Placebo 2|Women will receive subcutaneous placebo injections similar to GH daily starting from day 6 of hMG injections until the day of hCG injection
16016135|NCT02766751|Behavioral|HIVPASS|The 7-session HIVPASS intervention is provided to individuals randomized to the HIVPASS study arm.
16016136|NCT02766751|Behavioral|Health Education|The 7-sessions of Health Education is provided to individuals randomized to the Health Education study arm.
16016137|NCT02766738|Other|GrACE program|to compare with the GrACE + gait programme in RAC, as well as the secondary objective of measuring the programme benefits on gait speed, sit to stand and handgrip strength against the intervention and control group
16016138|NCT02766738|Other|GrACE + gait|to compare with the GrACE programme in RAC, as well as the secondary objective of measuring the programme benefits on gait speed, sit to stand and handgrip strength against the intervention and control group
16016139|NCT02766725|Drug|preparation F12 sildenafil in situ gel|in situ vaginal gel
16016140|NCT02766725|Drug|preparation F2 sildenafil in situ gel|in situ vaginal gel
16016141|NCT02766725|Drug|placebo gel|vaginal gel
16016142|NCT02766712|Procedure|Pace During 1st Half of Lesion|
16016143|NCT02766712|Procedure|Pace During 2nd Half of Lesion|
16016144|NCT02766699|Drug|EGFR(V)-EDV-Dox|EGFR(V)-EDV-Dox using EnGeneIC EDV™ technology is a bacterially derived minicell which packages a toxic payload, Doxorubicin, into a 400 nm particle which targets specific cancer cells using bispecific antibodies (BsAb). BsAb-targeted, payload-packaged EDV nanocells only exit the leaky blood vessels associated with tumors and enter into the tumor microenvironment. The BsAb binds to the tumor cell-surface receptor, where the EDV is taken up, broken down within the cancer cell and releases the Doxorubicin. The residual EDVs that do not make it into the tumor microenvironment, are engulfed by cells of the immune system and since the EDVs are derived from bacteria, they carry potent immuno-stimulating components which appear to bypass the immuno-suppression caused by the tumor.
16016145|NCT02766686|Radiation|Radiotherapy with protons|
16016146|NCT02766686|Radiation|Radiotherapy with photons|
16016147|NCT02766673|Drug|Albuterol Sulfate|Subjects will receive a dose of study medication every 4 hours for 24 total hours
16016148|NCT02766673|Drug|Sterile Saline|Subjects will receive a dose of study medication every 4 hours for 24 total hours
16016149|NCT02766660|Device|Optical Coherence Tomography|All groups were measured by optical coherence tomography.
16016150|NCT02766647|Biological|Filgrastim Hospira (US)|5 micrograms/kilogram (ug/kg) subcutaneous (SC) injection
16016151|NCT02766647|Biological|US-approved Neupogen®|5 micrograms/kilogram (ug/kg) subcutaneous (SC) injection
16016152|NCT02766634|Biological|Filgrastim Hospira (US)|5 micrograms/kilogram (ug/kg) subcutaneous (SC) injection once a day for 5 days
16016153|NCT02766634|Biological|U.S.-approved Neupogen®|5 micrograms/kilogram (ug/kg) subcutaneous (SC) injection once a day for 5 days
16016154|NCT02766621|Biological|PF-06823859|Comparison of different dosages of PF-06823859 to placebo
16016155|NCT02766621|Drug|Placebo injection SC/IV|Comparison of Placebo to different doses of PF-06823859
16016156|NCT02766608|Drug|BFF MDI 320/9.6 μg|Blinded Treatment
16016157|NCT02766608|Drug|BFF MDI 160/9.6 μg|Blinded Treatment
16016158|NCT02766608|Drug|FF MDI 9.6 μg|Blinded Treatment
16016159|NCT02766608|Drug|BD MDI 320 μg|Blinded Treatment
16016160|NCT02766608|Drug|Symbicort® TBH 400/12 μg BID|Open Label
16016161|NCT02766595|Other|hyperventilation while sitting up during routine EEG|Child will be asked to perform hyperventilation while lying down as well as while sitting up
16016162|NCT02766582|Drug|Pembrolizumab|IV every 21 days at 200 mg
16016163|NCT02766582|Drug|Carboplatin|IV every 21 days
16016164|NCT02766582|Drug|Paclitaxel|IV infusion (80mg/m2) every 7 days for 6 cycles
16016165|NCT02766569|Device|ASD closure with the Occlutech Flex II ASD closure device|Monitoring of possible device related side effects with a minumum of 1 year follow-up.
16016166|NCT02766556|Drug|dexmedetomidine|ISB with ropivacaine with dexmedetomidine or normal saline
16016167|NCT02766556|Procedure|ISB|ISB with ropivacaine with dexmedetomidine or normal saline
16016168|NCT02766556|Drug|Ropivacaine|ISB with ropivacaine with dexmedetomidine or normal saline
16016169|NCT02766543|Device|MRI-guided Transurethral Ultrasound Ablation|Magnetic resonance imaging-guided transurethral ultrasound ablation is a novel minimally-invasive procedure where the therapeutic endpoint is prostate ablation through thermal coagulation.
16016170|NCT02766530|Other|PETMR study|Use of PETMR study to evaluate the treatment response of breast cancer women
16016171|NCT02766517|Drug|Capsaicin|Administered topically
16016172|NCT02766504|Device|airway ultrasound|airway assessment using ultrasound
16016173|NCT02766491|Other|Strengthening and stretching|"Strengthening exercises will be performed 4 times a week for 10 weeks. Single leg heel raises will be the preferred exercise performed. The group of participants will have a wide range of strength and functional abilities, this will be accounted for with individualised programmes. The exercise load can be reduced by switching to bilateral heel raises, giving external support, reducing the range of motion or performing the heel raises while seated. Exercise load will be progressively increased by adding weight in the form of water bottles to a rucksack worn on the participant's back.
~For the final six weeks of the intervention, stretching exercises of the calf muscles will be performed."
16016174|NCT02766491|Other|conventional stretching|"This group will perform seated biceps curls 4 times a week for 10 weeks, where extra load can be added progressively by holding water bottles in the hand.
~For the final six weeks of the intervention, stretching exercises of the calf muscles will be performed."
16016175|NCT02766478|Drug|Genistein|Genistein is a natural supplement that comes from soy. Genistein will be taken orally (30 mg twice daily) for 12 weeks.
16016176|NCT02766478|Drug|Placebo|A placebo pill will be taken orally for 12 weeks.
16016189|NCT02766452|Behavioral|"You and your child in the recovery room DVD"|
16016190|NCT02766452|Behavioral|Standard pre-operative preparation|Attendance to the Pre-anesthetic assessment clinic to meet with registered practical nurse and anesthesiologist (physical assessment and medical history). Completion of the Surgery Virtual Tour.
16016191|NCT02766439|Drug|etanercept|25-mg etanercept injection subcutaneously twice a week
16016192|NCT02766426|Behavioral|Lifestyle change program|"Women attended a multidisciplinary counseling (by both the dietitian and the gynecologist). They were given nutritional advice about lifestyle and physical activity, in agreement with the Italian Guidelines for a healthy diet during pregnancy. The diet given comprised 1500 kcal/day and consisted of 3 main meals and 3 snacks (breakfast, snack, lunch, snack, dinner, and evening snack) that corresponds to the baseline metabolism of a pregnant woman. In view of the physical activity program, the dietitian added an amount of 200 kcal/day for obese or 300 kcal/day for overweight women.
~The exercise intervention was focused on increasing walking and developing a more active lifestyle. The recommendation for physical activity was to perform 30 min of moderate intensity activity at least 3 days a week."
16016193|NCT02766400|Behavioral|Guided Training|
16016194|NCT02766400|Behavioral|Directed Training|
16016195|NCT02766387|Other|Evaluation of the correlation between walking speed in the 6MWT and in 2MWT, and the walking speed observed in the continuous 2km walk test and in the 10 meters walk test.|
16016196|NCT02766374|Behavioral|Heart rate variability biofeedback|"Biofeedback teaches voluntary control of physiological functions by providing instantaneous feedback of variations in that bodily activity. Feedback usually is given in the form of visual and/or auditory signals derived from physiological recording devices. Among its salutary effects is a sense of medical self-efficacy, i.e., less dependency on medical professionals for maintaining personal health.
~The HRV-BF protocol we have developed and propose to examine herein works by a different pathway. It involves teaching the individual to increase the amplitude of heart rate accelerations during inhalation and de-celerations during exhalation, thus increasing the amplitude of respiratory sinus arrhythmia (RSA)."
16016197|NCT02766374|Behavioral|Placebo|"The method consists of: 1) receiving EEG/music biofeedback (actually, a mildly relaxing intervention, using EEG biofeedback to alternately increase and decrease frontal/occipital EEG alpha rhythms while listening to relaxing music), and 2) listening to recorded sounds of nature along with relaxing music with instructions to maintain a condition of relaxed alertness. For home training, subjects will be given placebo StressEraser programmed to give feedback to maintain their breathing at baseline rate."
16016198|NCT02766361|Behavioral|Cognitive Behavioral Rehabilitation|12 weekly sessions of Combined intervention lasting 90 minutes
16016199|NCT02766361|Other|Treatment as Usual|standard out-patient treatment offered in our clinic, which involves psychopharmacological mood stabilization and regular contacts with mental health nurses.
16016200|NCT02766348|Drug|gemcitabine|gemcitabine 1000mg/m2 IV on day 1 an day 8, repeat every 3 weeks
16016201|NCT02766348|Biological|DC-CTL|8×10^9 DC-CTL cells for each infusion, IV(In the vein) for 3 cycles, each cycle received four infusions on day 14,16,30 and 32
16016202|NCT02766348|Drug|cisplatinum|cisplatin 25mg/m2 IV on day 1,2 and 3, repeat every 3 weeks.
16016203|NCT02766335|Drug|Docetaxel|Given IV
16016204|NCT02766335|Biological|Durvalumab|Given IV
16016205|NCT02766335|Other|Laboratory Biomarker Analysis|Correlative studies
16016206|NCT02766322|Other|Oral Alcohol challenge test Alcohol visit first|Subjects will be assessed in two testing sessions about 1 week apart, in which their response to alcohol or nonalcoholic (placebo) beverage will be evaluated in a randomized cross-over fashion (visit 1 alcohol, visit 2 placebo).
16016207|NCT02766322|Other|Oral Alcohol challenge test Placebo visit first|Subjects will be assessed in two testing sessions about 1 week apart, in which their response to alcohol or nonalcoholic (placebo) beverage will be evaluated in a randomized cross-over fashion (visit 1 placebo, visit 2 alcohol).
16016208|NCT02766322|Other|Intravenous Alcohol Challenge Test (Clamp)|Subjects will be evaluated with an alcohol clamp (i.e. alcohol will be infused intravenously until reaching 60mg/dl and this blood alcohol concentration will be kept constant for two hours). We will record subjective responses to alcohol throughout different times of the clamp.
16016251|NCT02765971|Drug|picolax drops|Group B, 180 women will receive laxatives after their operating room discharge by 3 hours.
16016209|NCT02766322|Other|Intravenous Alcohol Self-administration Test|"Subjects will be asked to press a button (work) to receive either a drink or saline through an IV catheter. The amount of alcohol infused after earning their reward will be based on their body composition and will raise their blood alcohol level by 10 mg/dl (eight time less than the legal limit for driving). We will set a safety limit to 150 mg/dl so that subjects will not be allowed to work for alcohol until their blood alcohol levels go below that limit."
16016210|NCT02766309|Other|Sf12-v2|structured questioner Sf-12v2, developed by Ware.et al (Ware, Kosinski, Turner-Bowker & Gandeck, 2002).
16016211|NCT02766296|Behavioral|Active Emotional Working Memory Training|This training regimen has adapted the existing n-back paradigm, which has been widely used in the field. Training requires participants to shift between visual and auditory information while continually updating their working memory.
16016212|NCT02766296|Behavioral|Control Working Memory Training|This training utilized a fixed dual 1-back training paradigm.
16016213|NCT02766283|Drug|iodinated contrast agents|Intravascular application
16016214|NCT02766270|Drug|Temozolomide|RT with daily temozolomide (75 mg/m2/day, 7 days/week for up to 7 weeks) and adjuvant temozolomide (150-200 mg/m2 PO QD for 5 days, repeats every 28 days for up to 12 courses).
16016215|NCT02766270|Radiation|Radiotherapy|
16016216|NCT02766257|Procedure|Anesthesia for ambulatory paediatric surgery|
16016217|NCT02766244|Device|ICG/SPY|indocyanine green fluorescence imaging
16016218|NCT02766244|Drug|Antibiotic Ointment|Antibiotic ointment
16016219|NCT02766231|Device|Physica CR|Cruciate tretaining total knee replacement
16016220|NCT02766231|Device|Physica PS|Posterior Stabilized total knee replacement
16016221|NCT02766192|Drug|Ketamine|
16016222|NCT02766192|Behavioral|TIMBER Psychotherapy|
16016223|NCT02766192|Drug|Placebo (normal saline)|
16016224|NCT02766179|Device|CPAP|CPAP is used for 6 weeks
16016225|NCT02766179|Device|Somnoguard|Somnoguard is used for 6 weeks
16016226|NCT02766140|Drug|SHR1020 plus Docetaxel|SHR1020 20mg qd 2-21days, Docetaxel 60 mg/m^2 IV Day1/3weeks
16016227|NCT02766140|Drug|Placebo plus Docetaxel|Placebo matching SHR1020 qd 2-21days, Docetaxel 60 mg/m^2 IV Day1/3weeks
16016228|NCT02766127|Other|Veritise Flow|Self-adhering composite
16016229|NCT02766127|Other|Universal Dentin Sealant|non-polymerizable, high molecular weight resin sealant
16016230|NCT02766127|Other|Clearfil Protect Bond|methacrylate-based resin, self-etching adhesive system
16016231|NCT02766127|Other|Flor-Opal® Varnish|fluoride-based varnish
16016232|NCT02766114|Procedure|Carpal tunnel release through Mini Transverse Approach|Carpal tunnel release through a transverse cosmetic small incision over the distal wrist crease.
16016233|NCT02766101|Behavioral|Aerobic Exergaming PE Curriculum|Sustained aerobic exercise.
16016234|NCT02766101|Behavioral|Standard PE|Non-aerobic skill building.
16016235|NCT02766088|Procedure|Blood sample collection|All participants will have an enrolment visit with collection of a blood sample and a termination contact/visit. Participants or their parents/guardians will be contacted weekly or every two weeks to monitor the occurrence of febrile episodes. Additional visits will be made if febrile episodes occur. In case of dengue suspicion, a blood sample will be collected.
16016236|NCT02766075|Behavioral|Supervised TAVR Exercise Program|Individualized exercise program designed and implemented by licensed physical therapy clinicians in three 60-minute sessions per week for four weeks. Upon randomization, subjects in the Intervention Group will undergo an initial Dynamic Gait & Balance Assessment by a licensed physical therapy clinician. The physical therapy clinician will use this assessment to design and implement an individualized STEP in three 60-minute sessions per week for four weeks. Subjects will proceed with their pre-TAVR testing in conjunction with the STEP sessions.
16016237|NCT02766062|Other|metabolic syndrome|metabolic syndrome
16016238|NCT02766049|Biological|DC|Autologous dendritic cells (3x10e7)
16016239|NCT02766049|Biological|DC10e6+HIV-AT2|Autologous dendritic cells (3x10e6), pulsed with chemically inactive autologous HIV
16016240|NCT02766049|Biological|DC10e7+HIV-AT2|Autologous dendritic cells (3x10e7), pulsed with chemically inactive autologous HIV
16016241|NCT02766036|Drug|Propolis|Patients will receive 500 mg / day of the propolis extract in the form of tablets split in two daily doses
16016242|NCT02766036|Drug|Placebo|Patients will receive 500 mg / day of the placebo in the form of tablets split in two daily doses
16016243|NCT02766023|Biological|Lactobacillus crispatus CTV-05|LACTIN-V is an intravaginal live biotherapeutic product composed of Lactobacillus crispatus CTV-05 (LACTIN-V, Osel Inc) in a vaginal applicator. Subjects receive 2x10^9 cfu/dose applied vaginally daily x 5 days then twice weekly x 10 weeks.
16016244|NCT02766023|Drug|Metronidazole|Metronidazole is a nitroimidazole. Metronidazole gel (MetroGel) is applied vaginally 7.5 mg/gm daily for 5 days
16016245|NCT02766023|Other|Placebo|Placebo formulation applied vaginally, daily x 5 days then twice weekly x 10 weeks.
16016246|NCT02766010|Device|TensorTip|Non Invasive screening of various physiological and hematological parameters.
16016247|NCT02765997|Biological|Unmanipulated UCB|Unmanipulated UCB infusion given on Day 0. All patients will receive the same conditioning and immunoprophylaxis for the prevention of acute and chronic GVHD, previously demonstrated to offer the best outcomes in recipients of partially HLA matched UCB. Standard supportive care, including the use of Neupogen [G-CSF] and prophylactic anti-bacterial, protozoal, viral and fungal agents, will also be prescribed. Supportive care will be modified throughout the transplant course at the treating physician's judgement.
16016248|NCT02765997|Biological|SR-1 UCB|SR-1 UCB infusion given on Day 0. All patients will receive the same conditioning and immunoprophylaxis for the prevention of acute and chronic GVHD, previously demonstrated to offer the best outcomes in recipients of partially HLA matched UCB. Standard supportive care, including the use of Neupogen [G-CSF] and prophylactic anti-bacterial, protozoal, viral and fungal agents, will also be prescribed. Supportive care will be modified throughout the transplant course at the treating physician's judgement.
16016249|NCT02765984|Device|Transvaginal ultrasound|transvaginal ultrasound done before 10 weeks gestational age measuring the distance between the lower end of the hyperechoic trophoblast ring of the gestational sac and the inner cervical os
16016250|NCT02765971|Other|gums|Group A, 180 women will receive sugarless gum after their operating room discharge by 3 hours for at least half an hour at two hours interval.
16016252|NCT02765971|Drug|normal saline|Group C received 500 cc of normal saline, Intravenous fluid
16016253|NCT02765958|Device|portable ECG devise|
16016254|NCT02765945|Other|Supervised exercise program|Subjects were enrolled in a hospital-based wellness center where, after analysis of their medical history and previous levels of physical activity ands documentation of a normal exercise stress test, they chose individually tailored exercise programs
16016255|NCT02765932|Procedure|Dummy Movements|The placebo group will be asked to perform the same touch technique and count backwards from 50 while removing petals from a flower. Patients will also perform these techniques before rehab and sleep.
16016256|NCT02765932|Procedure|Psychosensory Therapy|The research assistant will administer one of the several psychosensory touch techniques prior to surgery. This will involve the touching of upper arms, palms, and a visualization process. This will last no longer than 10 minutes. These techniques will also be performed by the patients prior to any rehab sessions and before going to sleep. The patients will be asked to perform these touch techniques with the eyes closed and imaging having no pain. The patients will also be asked to keep a record of all medications.
16016257|NCT02765919|Radiation|HDR Brachytherapy of 9 Gy in 2 fractions|Two fractions of HDR brachytherapy following standard dose CCRT in locally advanced carcinoma cervix
16016258|NCT02765919|Radiation|HDR Brachytherapy of 7 Gy in 3 fractions|Three fractions of HDR Brachytherapy following standard dose CCRT in locally advanced carcinoma cervix
16016259|NCT02765906|Other|Graphic card|A randomized controlled trial comparing patient education on preeclampsia with a graphic card vs. patient education with a written pamphlet vs. no patient education showed that patient education improved significantly when patients were provided with a graphic card depicting signs and symptoms of preeclampsia and that this improvement occurred regardless of health literacy score (You WB, Wolf MS, Bailey SC, Grobman WA. Improving patient understanding of preeclampsia: a randomized controlled trial. American Journal of Obstetrics & Gynecology. 2012;206:431.e1-431.e5.). The graphic card is now available on the Preeclampsia Foundation's website (http://www.preeclampsia.org/market-place/educational-illustrated-signs-symptoms-pad-detail).
16016260|NCT02765906|Other|Video|This an informational video available on the Preeclampsia Foundation's website (http://www.preeclampsia.org/component/allvideoshare/video/featured/7-symptoms-every-pregnant-woman-should-know?Itemid=479). The effectiveness of this video has not yet been tested as an educational tool.
16016261|NCT02765893|Other|No Foley|Patients will have Foley catheter removed 6 hours post-op.
16016262|NCT02765880|Other|fMRI|Connectivity between the areas related to information processing over time and the areas activated during the rest activity. We will verify whether the activation anomalies observed during time tasks predict anomalies in spontaneous activity dynamics.
16016263|NCT02765880|Other|EEG|link between EEG response anomalies related to information processing over time and response anomalies recorded during rest activity. We will check whether anomalies in EEG oscillatory responses during time tasks predict anomalies during the rest task.
16016264|NCT02765867|Drug|RBP-6000|A single injection of RBP-6000 containing a low dose of buprenorphine in the Atrigel delivery system
16016265|NCT02765854|Drug|Dexamethasone|Given PO
16016266|NCT02765854|Drug|Ixazomib|Given PO
16016267|NCT02765854|Drug|Lenalidomide|Given PO
16016268|NCT02765841|Drug|Lomitapide|
16016269|NCT02765828|Other|Observational study|The following exams will be done in all cohorts: tongue manual muscle testing (MMT), tongue quantitative muscle testing, tongue ultrasound measurements
16016270|NCT02765815|Drug|Liposomal bupivacaine, 266mg|
16016271|NCT02765815|Drug|Bupivacaine 0.5 % with Epinephrine|
16016272|NCT02765815|Drug|Ketorolac 30mg|
16016273|NCT02765815|Drug|Morphine 10mg|
16016274|NCT02765815|Drug|Bupivacaine 0.25% with Epinephrine|
16016275|NCT02765802|Drug|Peginterferon Lambda-1A|
16016276|NCT02765789|Device|Immunoadsorption (Immunosorba)|Immunoadsorption as an alternative to plasma exchange
16016277|NCT02765776|Other|Observational retrospective cohort to describe RAL data|"This is an observational retrospective cohort in real world to describe RAL data, including NUC-sparing regimens, in aged HIV patients.
~In this retrospective analysis all naïve patients on raltegravir-based regimens and all patients switched to raltegravir-based regimens will be considered. For raltegravir-based regimens the investigators mean raltegravir as third agent in a triple regimen with NRTIs and also raltegravir-based regimens in NUC-sparing therapies. Data will be collected from medical records. The Time horizon for patient follow-up for outcome is at least 12 months."
16016278|NCT02765763|Drug|2-Minute Reveal Masque|
16016279|NCT02765763|Drug|24/7 Barrier Repair Cream|
16016280|NCT02765763|Drug|8-in-1 BioSerum|
16016281|NCT02765763|Drug|Null Formula 2-Minute Reveal Masque|
16016282|NCT02765763|Drug|Null Formula 24/7 Barrier Repair Cream|
16016283|NCT02765763|Drug|Null Formula 8-in-1 BioSerum|
16016284|NCT02765750|Behavioral|Intraoperative positive messages|"The message You are in the operating room. Everything is going very well. When you wake up you will be very calm, you will not feel pain and you will not have nausea will be played in greek language by headphones to the patient when the Bispectral Index (BIS) is 40-60."
16016285|NCT02765750|Behavioral|Intraoperative positive messages|"The message You are in the operating room. Everything is going very well. When you wake up you will be very calm, you will not feel pain and you will not have nausea will be played in greek language by headphones to the patient when the Bispectral Index (BIS) is 20-40."
16016286|NCT02765750|Behavioral|No message|The headphones will be placed on patient's ears but no message will be played.
16016287|NCT02765737|Other|Dehydrated Human Amnion/Chorion Membrane|Dehydrated human amnion/chorion membrane (dHACM) product and is regulated as a Human Cells, Tissues and Cellular and Tissue Based Product (HCT/P) under Section 361 of the Public Health Service Act by the Food and Drug Administration (FDA).
16016288|NCT02765737|Device|Mepilex Ag|
16016289|NCT02765724|Drug|Pacritinib|Pacritinib 400 mg (4 capsules of 100 mg each), single dose, oral administration
16016290|NCT02765685|Device|brace ODRA (PROTEOR company)|Port of the orthosis ODRA during day during 12 months, Complement to their usual care. The subjects will have for instruction to wear the brace a minimum of 6 hours a day, 5 days a week, And to remove it during the rest periods in lengthened position.
16016322|NCT02765516|Other|Placebo|Identical margarine without additional plant sterols to be consumed for 28 days
16016291|NCT02765685|Other|Usual care|"The patients will benefit only from the coverage proposed usually, by their regular doctor and according to the notices of the medical and paramedical specialists taking care of this pathology (physiotherapists, orthopaedic osteopaths, sports medicine physician, surgeon, rheumatologists, rehabilitative doctors, etc.). In the absence of recommendations on the modalities of coverage of the gonarthrose and in front of diverse clinical habits, the usual said coverage can be at the same time medicinal (anti-inflammatory, painkilling, …), non-medicinal (physiotherapy, port of an orthosis, …), even surgical, according to the influencers."
16016292|NCT02765672|Behavioral|Driving Behavior Interview|This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1)
16016293|NCT02765672|Other|Clinical Driving Assessment|Clinical Driving Assessment includes Optec vision screening, Useful Field of View, Range of Motion, Mini-Mental State Examination (MMSE) and Strength tests. This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1)
16016294|NCT02765672|Behavioral|Propensity for Angry Driving Scale|This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1)
16016295|NCT02765672|Behavioral|Community Integration Questionnaire|This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1)
16016296|NCT02765672|Behavioral|Satisfaction with Life|This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test 1
16016297|NCT02765672|Behavioral|Fitness-to-Drive Screening Measure (FTDS)|Fitness-to-Drive-Screening Measure will be completed twice, at baseline and at end of study
16016298|NCT02765672|Procedure|Simulated Driving Evaluation|This involves driving a simulator fitted simulated drives engineered to to address Veteran's driving concerns such as reactions to other drivers and road conditions(e.g. debris). The simulator is used at baseline and at post-test1 and 2. The intervention and traffic safety education session 3 also occurs using the driving simulator.
16016299|NCT02765672|Procedure|Driving Safety Education|This involves the following: Session1: general traffic safety discussion; Session 2: Rules of the road and acknowledgement of the road discussion and Session 3: driving the simulator without any feedback from traffic safety professional
16016300|NCT02765672|Procedure|Occupational Therapy Driving Intervention (OT-DI)|This has three sessions: 1. Driving evaluator reviews explicit driving errors with Combat Veteran; 2. driving evaluator provide tailored strategies to mitigate errors; Combat Veteran drives simulator with targeted feedback from driving evaluator.
16016301|NCT02765672|Procedure|On-road driving test|This involves and on-road driving test supervised by Driving Rehabilitation Specialist. To be completed at baseline and at month 5
16016302|NCT02765672|Procedure|Driving triggers evaluation|The simulator-drives evaluation group will evaluate the current simulator-triggers prior to baseline testing
16016303|NCT02765659|Behavioral|Mzake ndi Mzake T1|a 6-session peer group intervention focusing on primary HIV prevention and early testing and entry to treatment for secondary prevention - offered immediately after baseline
16016304|NCT02765659|Behavioral|Mzake ndi Mzake T2|a 6-session peer group intervention focusing on primary HIV prevention and early testing and entry to treatment for secondary prevention - offered immediately after post-T2 evaluation
16016305|NCT02765659|Behavioral|Mzake ndi Mzake T3|a 6-session peer group intervention focusing on primary HIV prevention and early testing and entry to treatment for secondary prevention - offered immediately after post-T3 evaluation
16016306|NCT02765646|Device|Coronary stent procedure (CSP)|
16016307|NCT02765633|Drug|Cangrelor|
16016308|NCT02765620|Other|drug&radiation|"Early treatment response assessment: using baseline data and early follow-up data
~Evaluate treatment response: using baseline data, early follow-up data and final data
~Compare PERCIST to RECIST criteria: correlation analysis
~Evaluate prognostic value: using baseline data, early follow-up data, final data as well as follow up PFS and OS time (Kaplan-Meier survival plot)"
16016309|NCT02765607|Procedure|Heart surgery|
16016310|NCT02765594|Drug|Hydroxychloroquine Sulfate|200mg bid
16016311|NCT02765594|Drug|Valsartan|160mg qd
16016312|NCT02765581|Device|Verum acupuncture|"The main acupuncture points are bilateral Hegu (L14) and Taichong (LR3), unilateral Taiyang(EX-HN5), Fengchi (GB20) and Shuaigu (GB8). Additional points can be chosen according to individual syndrome differentiation of meridians: (1) Yangming headache: Touwei (ST8); (2) Taiyang headache: Tianzhu (BL10); (3) Jueying: Baihui (GV20). The NO.16 special type of acupuncture (0.30 x 30 mm) produced by German asia-med company will be applied.The needles will be inserted into the skin of acupuncture points and manipulated manually by using the techniques such as lifting, thrusting, and twirling, until the internal compound sensation known as deqi."
16016313|NCT02765581|Device|Sham acupuncture|"We use a non-insertive sham control produced by Asia-med Company in Germany-the streitberger placebo-needle. Sham points are described as follows: 1) Bilateral of midpoint between acupoint Jianjin(GB21) and Jugu(LI16); 2) 5 cun lateral to the seventh thoracic spine; 3) 5 cun lateral to the eighth thoracic spine; 4) 5 cun lateral to the ninth thoracic spine. Cun is a distance measure unit used in locating acupoints in traditional Chinese medicine (TCM) acupuncture, and the width of patient's thumb interphalangeal joint is regarded as one cun."
16016314|NCT02765581|Behavioral|Usual care|Health education is provided in three aspects: lifestyle changes, behavioral therapies and migraine self-management.
16016315|NCT02765568|Behavioral|High Intensity Interval Training|Participants will complete supervised exercise sessions. Participants will attend on-site high-intensity interval training two times weekly for 12 weeks
16016316|NCT02765568|Behavioral|Moderate Intensity Continuous Exercise Training|Participants will complete supervised exercise sessions. Moderate-intensity continuous exercise training will follow cardiovascular rehabilitation guidelines. Participants will attend on-site moderate-intensity continuous exercise training two times weekly for 12 weeks.
16016317|NCT02765568|Behavioral|Nordic Walking|Participants will complete supervised exercise sessions. Participants will attend on-site Nordic walking training two times weekly for 12 weeks
16016318|NCT02765555|Drug|RBP-7000|Single dose
16016319|NCT02765542|Other|Automated disease assessment & self-care support phone calls|Automated disease assessment & self-care support phone calls for up to 12 weeks.
16016320|NCT02765529|Procedure|Blood sampling|
16016321|NCT02765516|Other|Plant sterols|2.0g/day of plant sterols incorporated into margarine to be consumed for 28 days
16016355|NCT02765256|Drug|Fluconazole placebo|Once daily
16016323|NCT02765503|Radiation|External beam radiotherapy|External beam radiotherapy using megavoltage radiotherapy with radical intent.
16016324|NCT02765490|Drug|AL-335|AL-335 800 mg (2*400) tablet will be administered once daily.
16016325|NCT02765490|Drug|Odalasvir|Odalasvir 25 mg tablet will be administered once daily.
16016326|NCT02765490|Drug|Simeprevir|Simeprevir 75 mg capsule will be administered once daily.
16016327|NCT02765451|Behavioral|interventions of the Cancéropôle Nord-Ouest|"During the time defined by the randomization, the Cancéropôle Nord-Ouest offers to help to develop a clinical research activities in the centers. The various aids are : Structuring clinical research at the local level, Support (strategy, logistics, technical, Data management, methodology), a portfolio of straightforward studies ( French National Cancer Institute, cooperative groups conducting cancer clinical research, New Project), Good Clinical Practice training, Clinical research technician, Others,....."
16016328|NCT02765438|Device|BOBO|"Each subject will play four games with the BOBO system."
16016329|NCT02765425|Device|AMES|Subjects will be trained while seated on the AMES device. As the footplate of the device rotates the ankle ±15 deg in dorsiflexion and plantarflexion, the participant will assist that motion. Vibration (2-3 mm at 60 pulses/s) will be applied to the tibialis anterior tendon during plantarflexion and to the Achilles tendon during dorsiflexion. To assist participants in the assisted movement task, the AMES biofeedback screen will provide real-time visual feedback of the volitional ankle torque that the participants actively apply to the AMES device. Each training session will include 15 min of training of each ankle; training sessions will be conducted 3 times/week over a 12-week period, for a total of 9 hours of training on each ankle.
16016330|NCT02765412|Other|Webinar, Promotion, and Tool Access|All sites will receive a professionally developed, 15-minute webinar that describes the tool's development (e.g., how the algorithm was designed) and a tutorial on how to use the web-site. The investigators will promote the webinar and using the tool through key local leaders. A web-link to use the tool will be placed within the lung cancer screening clinical reminder.
16016331|NCT02765412|Other|LEAP|Sites randomized to intensive implementation will be offered participation in the LEAP program. LEAP (Learn. Engage. Act. Program) is a multi-week, online learning collaborative using systems redesign techniques to help sites identify and overcome barriers to implementation of shared decision making (use of the Decision Precision tool).
16016332|NCT02765412|Other|Audit and Feedback|Providers at all sites will have access to this system. It will provide feedback on the screening and shared decision making process (e.g., number of provider's eligible patients screened for lung cancer, use of the tool, patient knowledge and satisfaction from patient surveys).
16016333|NCT02765412|Other|Academic Detailing|All sites will be offered an academic detailing approach to implementation of Lung Decision Precsion. A trained detailer will travel to all sites who agree to a visit. The detailer will meet with individual primary care providers whenever possible, and groups of providers as necessary. He will present evidence for a risk-based approach to screening and how to use the tool with patients to make tailored screening recommendations.
16016334|NCT02765399|Drug|Liraglutide|
16016335|NCT02765399|Drug|Placebo|
16016336|NCT02765386|Device|Hybrid fittings for cochlear implant recipients|
16016337|NCT02765373|Drug|Exemestane|
16016338|NCT02765373|Drug|Letrozole|
16016339|NCT02765373|Drug|Anastrozole|
16016340|NCT02765360|Other|Treatment Group|"Participants will be established on the randomised mode of ventilation and will have continuous assessment of the following during the assessment period:
~Electrical impedance tomography
~EMGpara
~SpO2
~tcCO2
~Pneumotachography
~End-tidal CO2 monitoring"
16016341|NCT02765347|Drug|Metformin|For arm 1, accept MDI or CSII plus metformin (initially starting dosage with 0.5g qd, then gradually increasing to 0.5g tid) for 24 weeks.
16016342|NCT02765347|Drug|Insulin|For arm 2, just accept insulin for 24 weeks
16016343|NCT02765334|Device|nBETTER|60 minutes of nBETTER training followed by 30 minutes of conventional therapy occupational therapy. Total of 18 sessions over 6 weeks.
16016344|NCT02765321|Behavioral|Healthy lifestyle promotion|Healthy lifestyle changes (i.e., increase in physical activity levels and improvement in eating habits) will be promoted via population-based counselling through media (i.e., radio, newspapers, magazines, television, banners), cell phone applicative, workshops, specific programs at schools and companies, and community physical activity programs.
16016345|NCT02765295|Device|medical ultrasonic hydrogen/oxygen nebulizer (MUNHO)|The medical ultrasonic nebulizers with hydrogen/oxygen generating function (MUNHO) will be provided exclusively by the sponsor, Asclepius Meditec Inc (Shanghai, China). The MUNHO consists of a electrolytic tank which, by using direct current converted from alternating current (220 V), generates the hydrogen and oxygen gas from pure water (2:1 in volume). The MUNHO is also capable of nebulizing the water via ultrasounds with the hydrogen-oxygen mixed gas which is finally delivered to the patient's airways via the facial mask through a plastic tube. Typically, the volume of hydrogen-oxygen mixed gas is 3 liters per minute (3 L/min).
16016346|NCT02765295|Device|Medical molecular mesh oxygen generator|"medical molecular mesh oxygen generator, type: OLO-1, oxygen flow: 3L/min; Shanghai Ouliang Medical Instrument Inc., Shanghai, China; Registration No.: Shanghai Medical Instrument approval No. 20152540046.
~This device has an identical appearance as compared with the MUHNO so that the patients could not readily discriminate with the MUHNO, and is also capable of displaying the actual cumulative duration of oxygen inhalation."
16016347|NCT02765282|Device|Algorithm based programming using Kinesia-based assessment|DBS-Expert includes a tablet-based software application (app) for guiding DBS programming and a Kinesia motion sensor unit for automated motor assessment. Algorithms search the programming parameter space to resolve an optimal set of programming parameters.
16016348|NCT02765269|Device|Intelligent Pain Management System|A mobile phone application which can record the pain the cancer patients have and can deliver these records to doctors in order that doctors give patients prescriptions promptly.
16016349|NCT02765256|Drug|Fluconazole|400mg orally once daily (Day 1-14)
16016350|NCT02765256|Drug|Vancomycin|500mg oral suspension 4 times daily (Day 1-14)
16016351|NCT02765256|Drug|Neomycin|neomycin 1000 mg orally three times daily (Days 1-3)
16016352|NCT02765256|Drug|Ciprofloxacin|ciprofloxacin 750 mg orally twice daily (Day 4-14)
16016353|NCT02765256|Drug|Polyethylene Glycol 3350|238 g dissolved in 64 ounces of Gatorade or Crystal Lite on day 2
16016354|NCT02765256|Drug|Promethazine|PRN (as needed) Promethazine 12.5mg up to every four hours (Days 1-3).
16016356|NCT02765243|Biological|Anti-GD2 CART|Anti-GD2 4th Generation Chimeric Antigen Receptor-modified T Cells
16016357|NCT02765217|Drug|Lactobacillus reuteri DSM 17938|Comparison the effects of Lactobacillus reuteri DSM 17938 and placebo for prevention of antibiotic associated diarrhea and also plan to compare the duration of treatment for on efficacy.
16016358|NCT02765217|Drug|Placebo|Comparison the effects of Lactobacillus reuteri DSM 17938 and placebo for prevention of antibiotic associated diarrhea and also plan to compare the duration of treatment for on
16016359|NCT02765217|Drug|Amoxicillin-Clavulanic Acid|All study patients will received amoxicillin-clavulanic acid at the dose of 50-90 mg/kg/day.
16016360|NCT02765204|Drug|Dapagliflozin|
16016361|NCT02765204|Drug|Saxagliptin|
16016362|NCT02765204|Drug|Glucose|
16016363|NCT02765191|Other|Plasma expansion with Ringer's Acetate|7,5 ml/kg mL Ringer's acetate during 5-10 minutes will be administered intravenously
16016364|NCT02765178|Other|Children's Motivation Scale|A 16-item questionnaire to evaluate level of motivation in children and adolescents completed by the primary caregiver.
16016365|NCT02765178|Other|Yale Global Tic Severity Scale (YGTSS)|Clinician administered questionnaire given to Tourette patients. Part 1 asks about 10 types of motor tics, 12 types of vocal tics (current, ever, age of onset, description). Part 2 is a severity rating that scores both motor and vocal tics on a 0-5 scale for each severity item: number of tics, intensity, frequency, complexity, interference, impairment. Totals are summed for all items.
16016366|NCT02765178|Other|Studies Depression Scale for Children (CES-DC)|"Clinician administered questionnaire given to Tourette patients. Consisting of 20 items, respondents are asked to indicate how strongly they have felt a certain way during the past week using a Likert-type scale that ranges from not at all to a lot. Only two items on the questionnaire relate specifically to sleep or fatigue. CES-DC is a validated score for assessing depression in children and adolescents"
16016367|NCT02765178|Other|Gilles de la Tourette Syndrome Quality Of Life scale|Clinician administered questionnaire given to Tourette patients. Gilles de la Tourette Syndrome Quality Of Life scale (GTS-QOL) is a recently validated score for the assessment of quality of life in patients with Tourette syndrome. Consisting of a 27-item GTS-specific HR-QOL scale (GTS-QOL) with four subscales (psychological, physical, obsessional, and cognitive).
16016368|NCT02765178|Other|Demographic Data|Data will be collected including: age, age at disease onset, gender, current medication regimen and presence of co-morbidities (like a diagnosis of ADHD, OCD, depression or insomnia).
16016369|NCT02765165|Drug|USL311|Administered once weekly in a 21-day cycle
16016370|NCT02765165|Drug|USL311|Administered once daily in a 21-day cycle
16016371|NCT02765165|Drug|USL311|Administered once daily in a 42-day cycle
16016372|NCT02765165|Drug|Lomustine|Administered once every 6 weeks in a 42-day cycle
16016373|NCT02765152|Other|Conventional Physical Therapy|Combination of joint mobility exercises, specific exercises for muscle strength and motor coordination exercises, unilateral and bilateral motor tasks as well as task-oriented training of the upper limb with a focus on functional tasks. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week)
16016374|NCT02765152|Other|Discrete movement training group|Aiming movements training with the affected upper limb (unilateral training) or both limbs (bilateral training) on the surface of a table. The starting point of the movement and its target are predetermined. Targets will be placed in different directions and distances from the starting point and the therapist ask for variations on speed and assistance, if necessary.
16016375|NCT02765152|Other|Rhythmic movement training group|Aiming movements training with the affected upper limb (unilateral training) or both limbs (bilateral training) on the surface of a table. The movement begins in a predetermined starting point, directed to a target and returns to the starting point. This activity is performed several times with rhythmic movements. Targets will be placed in different directions and distances from the starting point and the therapist ask for variations on speed and assistance, if necessary.
16016376|NCT02765139|Behavioral|Engaging Men through Accountable Practice|Engaging Men through Accountable Practice aims to engage men as agents of change through structured, weekly discussions with committed groups of men. It aims to address entrenched views of gender roles and identify positive models of masculinity. The approach follows a structured series of discussions designed to explore existing understandings of masculinity and create more positive models of what it means to be a 'good' man, promoting self-reflection and pushing men to analyze and change their own power and privilege. This methodology begins with a series of discussions with women to inform men's dialogue groups, and includes continuous feedback loops with women throughout the process so that the work with men is grounded in, and accountable to, women's views and objectives.
16016377|NCT02765139|Other|Alternative intervention|Control communities will receive an alternative intervention focused on a non-gender topic of 16 weekly sessions for men only.
16016378|NCT02765126|Biological|Seasonal influenza vaccine|Intramuscular standard seasonal influenza vaccine
16016379|NCT02765126|Biological|Diphtheria-tetanus-acellular pertussis vaccine|Intramuscular DTaP vaccine
16016380|NCT02765113|Procedure|Facial nerve combing|"Facial nerve combing:To sort out the facial nerve using the nerve combing knife.
~MVD: explore the facial nerve and trigeminal nerve and then perform microvascular decompression."
16016381|NCT02765113|Procedure|Facial and Trigeminal nerve combing|"Facial nerve combing:To sort out the facial nerve using the nerve combing knife.
~Trigeminal nerve combing:To sort out the trigeminal nerve using the nerve combing knife.
~MVD: explore the facial nerve and trigeminal nerve and then perform microvascular decompression."
16016382|NCT02765100|Drug|Minocycline|Minocycline 100 mg twice a day
16016383|NCT02765087|Other|Medical History|Oriented Survey and complete physical exam.
16016384|NCT02765087|Device|E-Nose|Patient will breath trough the device for 5 minutes, and during and after the intervention will be assessed for adverse effects related to the use of the e-Nose, according to the CTCEA
16016385|NCT02765087|Other|Chest CT|
16016386|NCT02765087|Other|Pleural Fluid Analysis|Cytomorphology Cytochemistry Adenosine Deaminase Value
16016387|NCT02765074|Drug|subcutaneous tocilizumab|162 mg subcutaneous, once a week during 12 months
16016427|NCT02764788|Other|seed auriculotherapy|non-specific auriculotherapy with seeds
16016428|NCT02764775|Device|Headpod|Adaptive equipment to assist with active head movements
16087672|NCT02253797|Drug|Tipranavir|
16016388|NCT02765048|Behavioral|GAIN Program|Receives GAIN, a 10-session program that incorporates cognitive behavioral therapy skills in a group format to address symptoms of trauma such as PTSD and depression related to histories of child maltreatment. GAIN includes the following elements: 1) assertive communication skills and relationship boundaries, 2) understanding the connection between feelings, thoughts, and behaviors, 3) increased personal confidence, 4) how to have healthy relationships and personal safety, and 5) how to cope with stress and anxiety.
16016389|NCT02765035|Device|C-Leg 4|Microprocessor Controlled Knee
16016390|NCT02765035|Device|C-Leg 3|Microprocessor Controlled Knee
16016391|NCT02765022|Device|Clip closure|Complete clip closure of secondary lesions after the endoscopic mucosal resection
16016392|NCT02765022|Procedure|No clip closure|Observation: no clip closure of secondary lesions after the endoscopic mucosal resection
16016393|NCT02765009|Drug|diuretics|Used to reduce fluid overload as evidenced by weight gain
16016394|NCT02765009|Drug|albumin|Used to reduce fluid overload in addition with diuretics in hypoalbuminemic patients
16016395|NCT02765009|Other|fluid restriction|Used to reduce fluid overload
16016396|NCT02765009|Device|renal replacement|Used to reduce fluid overload in patients with renal replacement
16016397|NCT02764996|Device|Acupuncture|
16016398|NCT02764983|Behavioral|Driving Behavior Interview|This will be completed thrice, at baseline, post-test1 and at post-test2
16016399|NCT02764983|Behavioral|Fitness-to-Drive Screening Measure|This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)
16016400|NCT02764983|Other|Clinical Driving Assessment|Clinical Driving Assessment includes Optec vision screening, Useful Field of View, Range of Motion, Strength. This will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)
16016401|NCT02764983|Behavioral|Propensity for Angry Driving Scale|This questionnaire will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)
16016402|NCT02764983|Behavioral|Community Integration Questionnaire|This questionnaire will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)
16016403|NCT02764983|Behavioral|Satisfaction with Life Questionnaire|This questionnaire will be completed thrice, at baseline, post-test1 and at post-test2 (3 months after post test1)
16016404|NCT02764983|Procedure|Driving simulator evaluation|The driving simulator evaluation uses a driving simulator with simulated drives engineered to address Veteran driving concerns such as reactions to other drivers and road conditions (e.g., debris). The simulator is used at baseline and post-tests 1 and 2. The intervention sessions (X3) also occur using simulator.
16016405|NCT02764983|Other|Focus Group Discussion Interview Guide|Focus group discussion will occur once using the interview guide
16016406|NCT02764970|Drug|Ivabradine 7.5mg orally|additive use to the standard medication with bisoprolol
16016407|NCT02764957|Dietary Supplement|green coffee extract|
16016408|NCT02764957|Dietary Supplement|placebo|
16016409|NCT02764944|Procedure|simple non-exposure EFTR|This intervention includes the steps of laparoscopic seromuscular suturing with a barbed suture thread (V-Loc), which results in inversion of the stomach wall; EFTR of the inverted stomach wall from inside the stomach; and finally, endoscopic mucosal suturing with endoloops and clips.
16016410|NCT02764931|Other|Gluten free oats and gastrointestinal health|Subjects will be served 3 different test meals in a randomized order in the cross-over design
16016411|NCT02764905|Behavioral|intensive cognitive physical rehabilitation program|include 2 phases: a) Intensive phase: weekly 4 hour group meeting which will include computerized cognitive training, aerobic, balance and strength exercise and group discussion that will be dedicated to cognitive rehabilitation strategies development and implementation with emphasis on disease management and physical activity as well as psycho-education on various disease management aspects (medical and nutritional) b) a consolidation phase: monthly 2 hour group discussions on challenges of implementation and coping strategies.
16016412|NCT02764892|Drug|V81444|Single oral dose of V81444
16016413|NCT02764879|Dietary Supplement|Omega 3 fatty acids|omega3 received 2 times daily-for 6 months
16016414|NCT02764879|Procedure|scaling and root planing|
16016415|NCT02764879|Other|placebo soft gelatin capsules|placebo soft gelatin capsules received 2 times daily-for 6 months
16016416|NCT02764866|Other|Sleep testing|Home sleep testing
16016417|NCT02764853|Behavioral|Experimental Intervention (STEP-AD)|This experimental intervention will consist of 10 sessions- 1 session of Lifesteps (problem solving for medication adherence) and 9 sessions of an intervention specifically tailored for Black women living with HIV to address trauma/abuse, racial discrimination, HIV stigma, and gender roles expectations in order to improve health outcomes (e.g., medication adherence, viral load), increase resiliency, and enhance adaptive coping strategies.
16016418|NCT02764853|Behavioral|Enhanced Treatment as Usual (E-TAU)|Participants assigned to the E-TAU condition will receive 1 session of Lifesteps (problem solving for medication adherence) and appropriate services and referrals as needed
16016419|NCT02764840|Other|isokinetic dynamometer|In the first stage a fatigue test will be applied. In the second stage, different participants will undergo a protocol for muscle strength gain. The first stage of the study will be crossover. The second will be split, one arm carry out the procedures in the elastic tube and the other in isokinetic dynamometer.
16016420|NCT02764840|Other|elastic tube|In the first stage a fatigue test will be applied. In the second stage, different participants will undergo a protocol for muscle strength gain.
16016421|NCT02764827|Biological|Pollen sensitization|Skin prick test with local and imported Bermuda, Johnson and careless weed allergen extracts at concentration of 10,000, 3,000, 1,000 and 300 AU/mL and measure specific IgE levels
16016422|NCT02764814|Other|Cryopreserved amniotic membrane|subjects will receive cryopreserved amniotic membrane
16016423|NCT02764801|Drug|Ultrasound contrast agent (Contrast-enhanced ultrasound)|Intravenous injection of ultrasound contrast agent followed by saline flush though an angiocatheter in the arm or hand.
16016424|NCT02764801|Device|Logiq E9 Scanner (Contrast-enhanced ultrasound)|Ultrasound scanning using a commercial scanner with a C1-5-D broad-spectrum convex transducer followed by a RAB2-5-D broad-spectrum real-time 4D transducer.
16016425|NCT02764788|Other|Specific auriculotherapy|Specific auriculotherapy with needles
16016426|NCT02764788|Other|non-specific auriculotherapy|non-specific auriculotherapy with needles
16016432|NCT02764749|Dietary Supplement|cranberry (poly)phenol containing supplement|Sustained intake of 9 grams of freeze-dried cranberry powder per day (2x 4.5 grams daily over 1 month). The powder is dissolved in water and administered as a drink.
16016433|NCT02764749|Dietary Supplement|Placebo comparator: cranberry (poly)phenol deprived supplement|Sustained intake (2x 4.5 grams daily over 1 month) of a control supplement dissolved in water
16016434|NCT02764736|Drug|Atorvastatin|Patients will be given 20mg atorvastatin daily for 12 weeks and then increased to 40mg atorvastatin daily for an additional 12 weeks.
16016435|NCT02764723|Drug|Hyperbaric bupivacaine|12.5 mg of hyperbaric bupivacaine 0.5% for spinal anesthesia in geriatric patients undergoing total knee arthroplasty
16016436|NCT02764723|Drug|Isobaric ropivacaine|15 mg of isobaric ropivacaine 0.5% for spinal anesthesia in geriatric patients undergoing total knee arthroplasty
16016437|NCT02764710|Drug|Amoxicillin-Potassium Clavulanate Combination|"Short course of postoperative treatment: amoxicillin-clavulanate 875mg, one tab twice daily for a total of 2 doses.
~Long course of postoperative treatment: amoxicillin-clavulanate 875mg, one tab twice daily up until and including postoperative day 7."
16016438|NCT02764697|Drug|H.P. ACTHAR SUBCUTANEOUS GEL INJECTION|Subcutaneous injection twice weekly
16016439|NCT02764684|Drug|Probiotic|The probiotic strain Lactobacillus rhamnosus will be self-administrated twice a day, one capsule in the morning and one in the evening for eight weeks.
16016440|NCT02764671|Biological|10μg/0.5ml recombinant hepatitis B vaccine|5000 participants who are healthy neonates receive 10μg/0.5ml recombinant hepatitis B vaccine on day 0, 30 and 60.
16016441|NCT02764658|Device|Pulmonary recovery on the AECOPD|The combination effect of negative pressure ventilation, limb muscle exercise training program and fibit monitor on acute exacerbation of AECOPD. To investigate the daily physical activity in routine care patients with after AECOPD and stable stage.
16016442|NCT02764658|Other|Routine care on the AECOPD|To investigate whether daily physical activity、hypoxia and hyperinflation were associated with airway inflammation and PRG4 in Routine care patients wtih AECOPD and stable stage.
16016443|NCT02764658|Other|Routine care on the stable COPD|To investigate whether daily physical activity、hypoxia and hyperinflation were associated with airway inflammation and PRG4 in Non-Pulmanary recovery patients wtih stable COPD.
16016444|NCT02764645|Device|CardioGard Cannula|"CardioGard Cannula is a specially designed arterial (aortic) cannula for use in cardiac surgery for the purpose of removal of gaseous and solid embolic material emanating during the CPB procedure.
~The CardioGard cannula is a double lumen cannula where the primary lumen provides blood from the heart-lung machine similar to ordinary cannulas and the secondary lumen performs suction of blood and embolic matter away from the aortic arch and back to the cardiopulmonary bypass machine for filtration."
16016445|NCT02764645|Device|22Fr curved Cannula|arterial cannula for use in cardiac surgery
16016446|NCT02764632|Procedure|Digital facilitation|
16016447|NCT02764619|Drug|Spironolactone|
16016448|NCT02764619|Drug|Placebo|
16016449|NCT02764606|Biological|Serum and plasma samples|Serum and plasma are collected at time of diagnosis, after surgery, and at time of progression to evaluate the value of new serum markers to predict the occurrence of metastases.
16016450|NCT02764593|Drug|Nivolumab|Anti-PD-1 targeted immunotherapy
16016451|NCT02764593|Drug|Cisplatin|Anti-cancer alkylating agent
16016452|NCT02764593|Drug|Cetuximab|Epidermal Growth Factor Receptor (EGFR) antagonist
16016453|NCT02764593|Radiation|IMRT|High-precision radiotherapy
16016454|NCT02764567|Other|Essential Oil|Participants in this arm will be offered one of three essential oils: ginger, lavender or calming
16016455|NCT02764541|Drug|Letrozole|
16016456|NCT02764541|Drug|Tamoxifen|
16016457|NCT02764541|Drug|Palbociclib|
16016458|NCT02764541|Drug|Endocrine Therapy|
16016459|NCT02764528|Behavioral|Clinic|Pregnant women will receive handwashing promotion from a trained facility-based health care worker during her regular antenatal visit at a healthcare clinic. To the extent feasible, everyone accompanying the pregnant woman will be invited to take part in the behavior change communication session. The participant will be provided with several bars of soap to take home and she will be encouraged to maintain a designated place for washing hands (with soap and water) at the home. A poster indicating the key events for handwashing with soap will be posted at the clinic and smaller posters will be given to the participant to post in her home. A system will be established to send regular SMS messages to the participant promote handwashing with soap during the neonatal period.
16016460|NCT02764528|Behavioral|Clinic + home|Women will receive all components of the clinic-based handwashing promotion in addition to handwashing promotion during 3-4 home visits before their expected delivery date and during the neonatal period from a community health volunteer. All household members present will be invited to join in the session, with emphasis on including all caregivers of the neonate.
16016461|NCT02764528|Behavioral|Clinic + home + handwashing device|Women will receive all components of the clinic + home-based handwashing promotion intervention in addition to one handwashing device (i.e. tap and basin to use as a handwashing station) during the first home visit by the community health volunteer. The community health volunteer will work with the woman and her family to identify the location where the neonate will be most of the time in order to position the handwashing station as close to the neonate as possible.
16016462|NCT02764515|Drug|Kunxian Capsule|Patients in the Kunxian Capsule group will take Kunxian Capsule 0.6gm orally twice daily for 24weeks
16016463|NCT02764515|Drug|Methotrexate|the Methotrexate group will take Methotrexate 10mg orally every week for 24 weeks
16016464|NCT02764502|Device|Pressure Gauge Manometer|Identification of epidural space
16016465|NCT02764489|Biological|FEIBA|Anti-inhibitor Coagulant Complex Nanofiltered (activated prothrombin complex concentrate [APCC]), FEIBA NF.
16016499|NCT02764203|Device|Wearable devices|Up to three wearable devices will be worn by the subject to measure parameters such as heart rate, blood pressure and number of steps
16016500|NCT02764190|Behavioral|I-ACT with Check Yourself|
16016501|NCT02764177|Dietary Supplement|Protein drink|The protein drink was administered during this trial
16016502|NCT02764177|Dietary Supplement|Carbohydrate drink|The carbohydrate drink was administered in this trial
16016466|NCT02764476|Other|Embodied Virtual Reality Therapy|Participants will be asked to play a game in Stanford's Virtual Reality Human Interaction Lab that engages visual pathways and involves body tracking and controlled sensory feedback reinforcing movement in real and virtual time by immersive head mounted displays. This game will have subjects fully embody and inhabit an avatar from an egocentric perspective. In addition, over consecutive sessions subjects will be asked to use a mobile smart phone based virtual reality program designed to deliver various and customized emotionally provocative stimuli.
16016467|NCT02764476|Other|Virtual reality|Participants will be asked to play a game in Stanford's Virtual Reality Human Interaction Lab that engages visual pathways.
16016468|NCT02764463|Device|Fiber Reinforced Composite Fixed Partial Dentures|All restorations were made indirectly on a plaster model using unidirectional E-glass fibers (Vectris- Ivoclar Vivadent, , liechtenstein) in combination with a laboratory resin composite (Signum, Heraeus-Kulzer)
16016469|NCT02764450|Device|Astralis 10 HPM|The cavity to be filled is in quadrant I or III
16016470|NCT02764450|Device|Astralis 10 RM|The cavity to be filled is in quadrant II or IV
16016471|NCT02764437|Biological|Whole lung antigen challenge, segmental allergen challenge|Whole lung antigen challenge with housedust mite, short ragweed or cat hair allergen extracts. Segmental allergen challenge with housedust mite, short ragweed or cat hair allergen extracts.
16016472|NCT02764424|Device|NIPE (MDoloris®)|Each file consists of a simultaneous recording of an electrocardiogram signal according to usual practice (cardiac monitor PHILIPS), coupled with a concomitant registration of NIPE (Newborn Infant Parasympathetic Evaluation - MDoloris®). The electrocardiogram signal, respiration rate, oxygen saturation (SpO2) and NIPE are recorded simultaneously on a computer with a capture card. The other indices of Heart Rate Variability will be analyzed offline.
16016473|NCT02764411|Drug|Brimonidine 0.33% gel|Topical application of Brimonidine 0.33% gel on Capillary Malformation (CM) lesion once daily for 12 weeks
16016474|NCT02764385|Other|Teachable Moment Communication Process|A clinician-focused intervention designed to guide an approach to discussing smoking cessation during routine primary care visits.
16016475|NCT02764385|Other|AAC|A system-based change to the EHR that allows for eReferral to the Quitline coupled with role and process changes for medical technical assistants
16016476|NCT02764372|Behavioral|Serious games|Participants played serious games developed for Kinect in the the EU FP7 STREP Project REHAB@HOME N. 306113
16016477|NCT02764372|Behavioral|Exergames|Participants played exergames existent in the Wii game console
16016478|NCT02764359|Drug|IV vancomycin|IV vancomycin for the treatment of infection. Following the vancomycin loading dose, vancomycin dosing will be at the discretion of the pharmacist and attending physician and will follow standard of care.
16016479|NCT02764346|Behavioral|iCanCope app|"In addition to standard medical care, adolescents in the experimental group will receive access to the iCanCope smartphone app for 8 weeks. The app consists of daily pain symptom tracking (pain intensity, sleep, mood, physical activity, and fatigue), goal setting, in-the moment coping strategies, as well as a social community component."
16016480|NCT02764346|Behavioral|iCanCope attention control app|"The control group is designed to control for the potential effects on outcomes of time, attention, and smartphone use during the intervention. In addition to standard medical care, adolescents in the attention control group will receive access to the iCanCope control app, with limited functionality."
16016481|NCT02764333|Biological|TPIV200|
16016482|NCT02764333|Biological|Durvalumab|
16016483|NCT02764320|Other|Treatment Strategy|Both arms will initiate or optimize preventive medications. Subjects in the Discontinuation arm will stop overused medications and use an alternative rescue medication(s) with a limited frequency. Subjects in the Preventive Therapy Only arm will initiate or optimize preventive medications without immediately discontinuing the overused medication.
16016484|NCT02764307|Device|Constant jet nebulizer|A constant jet nebulizer (Neb-easy, Galemed Corp., Taiwan) was tested with salbutamol sulfate powered by compressed gas flow at 6 L/min.
16016485|NCT02764307|Device|Breath enhanced nebulizer|A breath enhanced nebulizer (Pari LC plus, Pari Inc., Germany) was tested with salbutamol sulfate powered by compressed gas flow at 6 L/min.
16016486|NCT02764307|Device|Manual-actuated nebulizer|A manual-actuated nebulizer (A-T Neb, Atlantean Corporation, Taiwan) was tested with salbutamol sulfate powered by compressed gas flow at 6 L/min.
16016487|NCT02764307|Device|Breath-actuated nebulizer|A breath-actuated nebulizer (AeroElipes, Trudell Medical Inc, Canada) was tested with salbutamol sulfate powered by compressed gas flow at 6 L/min.
16016488|NCT02764294|Other|Music Group|Music group was listened to a music of their choise with a headset. The music intervention was started about 10-15 minutes before cystoscopy and continued during the whole procedure. Types of music were Turkish folk music, Turkish art music, Turkish arabesque music, Turkish pop music, foreign pop music, rock music, and classical music.
16016489|NCT02764294|Other|Stress Ball Group|"Music group was given stress ball into both their palms about 10-15 minutes before cystoscopy. Participants were instructed to squeeze the balls twice after counting up to five and repeat it until the end of the procedure."
16016490|NCT02764294|Other|DVD Group|DVD group was started to be watched a DVD of their choise about 10-15 minutes before cystoscopy and continued during the whole procedure.
16016491|NCT02764281|Drug|MEDA|"Methotrexate, 3.0g/m2/d iv, day 1
~Etoposide, 100mg/m2 iv, day 2 to day 4
~Dexamethasone, 40mg/d iv, day 1 to day 4
~Pegaspargase, 2500IU/m2/d im, day 4
~The MEDA chemotherapy will be repeated every 3 weeks."
16016492|NCT02764281|Procedure|Auto-HSCT|Auto-HSCT will be performed with patients who responded to the initial MEDA chemotherapy with standard BEAM conditioning regimen.
16016493|NCT02764268|Drug|Apatinib|
16016494|NCT02764242|Other|Skin prick test|Skin prick tests to local and imported insect sting allergen with different concentration are performed.
16016495|NCT02764242|Other|sIgE measurement|sIgE levels to stinging insect allergen and their recombinant venom allergen are measured
16016496|NCT02764229|Drug|LYC-30937-EC|LYC-30937-EC 25 mg by mouth once daily
16016497|NCT02764216|Radiation|Elective mucosal irradiaton|Patients will elective mucosal irradiaton based on nodal station, EBV/HPV status, RPN status etc. IMRT will be adopted.
16016498|NCT02764203|Other|Dark Chocolate|50g dark chocolate consumed for a period of 2 weeks
16016609|NCT02763410|Other|PRBC transfusion|
16016694|NCT02762864|Other|platelet (P2Y12) reaction units|VerifyNow P2Y12 assay point-of-care testing
16016503|NCT02764164|Device|Intervention Active tDCS|Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current delivered directly to the brain area of interest via small electrodes. Placed over the temporoparietal junction to suppress auditory hallucinations.
16016504|NCT02764151|Drug|PF-06840003|Daily Oral PF-06840003
16016505|NCT02764138|Behavioral|Building a Strong Identity and Coping Skills|Psychoeducational program to teach children coping skills, healthy identity development, and collective social action.
16016506|NCT02764125|Drug|Stalevo|levodopa/carbidopa/entacapone
16016507|NCT02764125|Drug|levodopa MR|levodopa MR/carbidopa/ODM-104
16016508|NCT02764099|Behavioral|Life Skills Training|The Life Skills Training (LST) program is a comprehensive competence enhancement prevention approach that teaches resistance skills while also emphasizing generic personal and social skills training. The LST program content and skills training is delivered to youth participants by trained providers through instruction, demonstration, behavioral rehearsal with feedback and social reinforcement, extended practice through homework assignments, and didactic teaching methods.
16016509|NCT02764086|Radiation|Radiation|Escalated dose of minimum 65Gy to the iGTV, with 60 Gy to PTV.
16016510|NCT02764073|Device|Bioimpedance spectroscopy|The technique involves attaching electrodes to the patient's forearm and ipsilateral ankle, with the patient in a supine position. The BCM® measures the body resistance and reactance to electrical currents of 50 discrete frequencies, ranging between 5 and 1000 kHz. Based on a fluid model using these resistances, the extracellular water (ECW), the intracellular water (ICW) and the total body water (TBW) are calculated. All calculations are automatically performed by the software of the BCM® device. Absolute fluid overload (AFO) is is defined as the difference between the expected patient's ECW under normal physiological conditions and the actual ECW, whereas the relative fluid overload (RFO) is defined as the absolute fluid overload AFO to ECW ratio.
16016511|NCT02764073|Device|Lung Ultrasonography|Examinations will be performed in the supine position. Scanning of the anterior and lateral chest will be performed on both sides of the chest, from the second to the fourth (on the right side to the fifth) intercostal spaces, at parasternal to mid-axillary lines. B-lines will be recorded in each intercostal space and were defined as a hyperechoic, coherent US bundle at narrow basis going from the transducer to the limit of the screen. B-lines starting from the pleural line can be either localized or scattered to the whole lung and be present as isolated or multiple artifacts (with a distance 7 mm between 2 artifacts). The sum of B-lines produces a score reflecting the extent of lung water accumulation (0 being no detectable B-line).
16016512|NCT02764073|Device|Echocardiography|All echocardiographic measurements will be carried out according to the recommendations of the American Society of Echocardiography by an observer unaware of the lung ultrasound and bioimpedance results. Echocardiographic evaluation will provide information about cardiac anatomy (e.g. volumes, geometry, mass) and function (e.g. left ventricular function and wall motion, valvular function, right ventricular function, pulmonary artery pressure, pericardium).
16016513|NCT02764060|Device|Tongue scraper|The patients were instructed to start cleaning the tongue by two pulling strokes along the median sulcus of the tongue, followed by two pulling strokes along the lateral edges of the tongue.
16016514|NCT02764060|Device|Toothbrush|The patients who were assigned to the tooth brush group were taught to perform three forward and backward strokes along the median sulcus and at each lateral part of the tongue.
16016515|NCT02764047|Dietary Supplement|Probiotic|L. acidophilus 10⁹, B. lactis 10⁹
16016516|NCT02764034|Device|Low level Laser diode machine|wavelength 635 Low level diode laser power control time control Continuous mode
16016517|NCT02764021|Dietary Supplement|Carbohydrate-Restricted Diet|Macronutritional composition: Carbohydrate 30 E%, Protein 30 E%, Fat 40 E%
16016518|NCT02764021|Dietary Supplement|Standard Antidiabetic Diet|Macronutritional composition: Carbohydrate 50 E%, Protein 13 E%, Fat 17 E%
16016519|NCT02764008|Drug|Bupivacaine|20 ml %0,25 bupivacaine
16016520|NCT02764008|Device|Ultrasound|
16016521|NCT02763995|Behavioral|Pharmaceutical care|This is a quasi-experimental study and the same group will be evaluated before and after the follow up.
16016522|NCT02763982|Other|Physical evaluation|
16016523|NCT02763969|Drug|BMS-986202|
16016524|NCT02763969|Drug|Placebo|
16016525|NCT02763969|Drug|Interferon alpha-2a recombinant|
16016526|NCT02763969|Drug|Famotidine|
16016527|NCT02763969|Drug|Ustekinumab|
16016528|NCT02763956|Device|GelStix™ Nucleus Augmentation Device|Intradiscal Gelstix insertion
16016529|NCT02763956|Other|Placebo|Intradiscal saline injection
16016530|NCT02763943|Behavioral|Pharmacist-led, technology enabled education intervention|Prospective, non-randomized, pilot study assessing the feasibility and potential efficacy of a 6-month, pharmacist-led, technology enabled education intervention on improving medication safety and cardiovascular risk factor control in adult solitary kidney transplant recipients with a secondary aim of assessing if the impact of the intervention varies by race.
16016531|NCT02763930|Other|Control diet|
16016532|NCT02763930|Other|Milk diet|
16016533|NCT02763930|Other|GABA-rich cheese diet|
16016534|NCT02763917|Device|Active Air Purifier|Two portable air purifiers containing HEPA filters will be placed in the bedroom and room where the participant reports spending the most time. Participants will be instructed to run the air purifiers continually. Participants will receive educational materials about environmental factors that are important for asthma health and environmental modification strategies, and educational materials about health benefits of maintaining a normal weight.
16016535|NCT02763917|Device|Placebo Air Purifier|Homes in the control group will receive placebo air purifiers that have the internal air filters removed, but which will run normally. Participants will receive educational materials about environmental factors that are important for asthma health and environmental modification strategies, and educational materials about health benefits of maintaining a normal weight. At the end of the study, participants in the control group will receive active air purifiers. A control group is needed to ensure that reduced pollutant levels and health effects are not due to temporal trends and 'placebo effects' of being enrolled in an intervention trial. Participants will be informed that being in the study does not prevent them from purchasing and using air cleaners during the study period.
16016536|NCT02763904|Dietary Supplement|Intensive nutritional counseling|Dietary counseling + energy-dense oral nutritional supplements since admission
16087673|NCT02253797|Drug|Ritonavir|
16016537|NCT02763904|Other|Dietary counseling|Dietary counseling alone. In case of inadequate energy intake patients will receive oral nutritional supplements since day 8 from admission (after the evaluation of the primary end point)
16016538|NCT02763891|Other|Intervention group (Body body suspension and tilting exercises)|The body suspension and tilting exercise program (Chordata Method) involved suspending the body in the apparatus while performing tilting exercises. The Chordata apparatus consists of a steel structure with special springs and a harness specifically manufactured for practicing the Chordata Method. During the training sessions, the prescribed exercises emphasize the repetition of movements designed to promote different types of muscle contractions (concentric, eccentric, static) performed in different body positions and joint angles. Thus, when using the method, patients experience maximal functional performance beyond to the body mass centre, activating trunk antagonist muscles and motor memory evocation. Each session lasts 30 minutes.
16016539|NCT02763891|Other|Control group (global muscle stretching)|Subjects receiving submitted a global muscle stretching session twice a week for eight weeks. During this period. All participants are requested to don't engage in any additional type of exercise program or physical activity throughout the study period.
16016540|NCT02763878|Procedure|Uncut Roux-en-Y anastomosis|Uncut Closure devices would be used to close the intestinal cavity on the input less than 5cm distance from the loop gastrojejunostomy anastomosis.
16016541|NCT02763878|Procedure|Billroth II anastomosis|Typical Billroth II anastomosis would be made after the Distal gastrectomy.
16016542|NCT02763865|Device|MagVenture MagProx100 Stimulator with a Cool-B65 A/P coil|"Active rTMS administration (1Hz, 1,200sec, 110% resting motor threshold (rMT); 1200 pulses total.
~Resting motor threshold assessment the TMS machine will initially be set to 50% of its maximal output."
16016543|NCT02763865|Device|eSHAM system|implemented in conjunction with the Cool-B65 A/P coil to effectively blind participants to rTMS treatment (active or sham)
16016544|NCT02763852|Drug|BIA 3-202|"The study consisted of 5 treatment periods. Eligible subjects were admitted to the UFH on the morning of the day prior to receive the trial medication (dosing day) and remained in the unit for at least 30 h post-dose.
~Subjects were to receive BIA 3-202 50 mg, 100 mg, 200 mg, 400 mg and placebo at 5 separate treatment periods."
16016545|NCT02763852|Drug|Placebo|Placebo dose consisted of 5 tablets matching BIA 3-202 100 mg tablets; oral route.
16016546|NCT02763852|Drug|Madopar® 125|Levodopa 100 mg/benserazide 25 mg capsules (Madopar® 125, marketed by Roche products Limited); oral route.
16016547|NCT02763839|Drug|BIA 3-202|"The study consisted of 5 treatment periods. Eligible subjects were admitted to the UFH on the morning of the day prior to receive the trial medication (dosing day) and remained in the unit for at least 30 h post-dose.
~Subjects were to receive BIA 3-202 50 mg, 100 mg, 200 mg, 400 mg and placebo at 5 separate treatment periods."
16016548|NCT02763839|Drug|Placebo|Placebo dose consisted of 5 tablets matching BIA 3-202 100 mg tablets; oral route
16016549|NCT02763839|Drug|Sinemet 25/100|Levodopa 100 mg/carbidopa 25 mg (Sinemet 25/100, Merck Sharp & Dohme) tablets; oral route.
16016550|NCT02763826|Device|transcranial direct current stimulation|brain stimulation using progressively increasing amounts of direct currents and in a variety of electrode montages
16016551|NCT02763813|Device|Herbst (propulsion type oral appliance)|Oral appliance
16016552|NCT02763813|Device|Retention type appliance (ORM)|
16016553|NCT02763800|Drug|BIA 3-202|BIA 3-202 (50, 100 and 200 mg) was administered in the form of oral tablets, given with 200 ml potable water.
16016554|NCT02763800|Drug|Placebo|Matched placebo was administered in the form of oral tablets, given with 200 ml potable water
16016555|NCT02763787|Drug|BIA 3-202|single rising oral doses (10 mg, 30 mg, 50 mg, 100 mg, 200 mg, 400 mg, 800 mg)
16016556|NCT02763787|Drug|Placebo|Identical placebo
16016557|NCT02763774|Other|Walking exercise|Participants will be sumitted to progressive exercises and supervised by a physiotherapist, active-assisted to free active exercise in upper and lower limbs, stationary running and walking. The intensity of walk will be determined by the Borg's sujective effort perception scale - (modified from zero to 10). On first postoperative day, participants will perform exercises in supine position. From the second to the fifth postoperative day, they will perform progressive walking.
16016558|NCT02763774|Other|Stationary cycling exercise|Participants will be sumitted to progressive exercises and supervised by a physiotherapist, active-assisted to free active exercise in upper and lower limbs. From the first to the fifth postoperative day, they will perform progressive cycling exercise.The intensity of cycling will be determined by the Borg's sujective effort perception scale - (modified from zero to 10).
16016559|NCT02763774|Other|Neuromuscular electrical stimulation|Participants will be sumitted to progressive exercises and supervised by a physiotherapist, active-assisted to free active exercise in upper and lower limbs. From the first to the fifth postoperative day, quadriceps and gastrocnemius muscles will be percutaneous stimulated with the following parameters: Synchronic mode, 50Hz, 400uS, time on 10s, time off 20s, intensity as tolerated by the patient.
16016560|NCT02763761|Drug|Infliximab + Prednisone|Prednisone dose will be decreased every 3 days for 18 days
16016561|NCT02763761|Drug|Methylprednisolone + Prednisone|Prednisone dose will be decreased every 4 days for 40 days
16016562|NCT02763748|Procedure|Laparoscopic endoscopy combined surgery|
16016563|NCT02763748|Procedure|laparoscopic and endoscopic cooperative surgery|
16016564|NCT02763748|Procedure|Single-arch laparoscopic and endoscopic cooperative surgery|
16016565|NCT02763722|Other|Emollient spray product|All patients will be instructed to use emollients spray on entire skin at least twice a day for four weeks.
16016566|NCT02763696|Other|Composition of Viginal flora of Child-Bearing women|Use high-throughput sequencing technology to exam Composition of Viginal flora of Child-Bearing women in different menstrual cycle and type of Vaginitis
16016567|NCT02763683|Radiation|PiB and VAT|There is no intervention for this study. The PiB and VAT are used during the PET procedures to help to identify any excessive abnormal proteins in the brain.
16016610|NCT02763397|Device|NBM-DBS|DBS which has already been implanted aiming initially to stimulate the GPi will be reprogrammed in order to stimulate more distal structure, the NBM.
16016611|NCT02763397|Device|DBS|DBS will be switched off
16016612|NCT02763384|Drug|BL-8040|
16016613|NCT02763384|Drug|Nelarabine|
16016797|NCT02762032|Drug|Placebo|Placebo supplement to take BID for 14 weeks in Arm 3
16087674|NCT02253784|Drug|Dexamethasone|
16016568|NCT02763670|Other|PRETICARD patient care management|"A standardized and specialized network to take care of the severe cardiac insufficiency:
~An initial assessment and consultations with health professionals specialized in severe cardiac insufficiency during the hospitalization for cardiac insufficiency
~At 1 months, consultations and acts realized by health professionals specialized (one hospital day care)
~At 2 months, a therapeutic education program for heart failure patients, approved by the Rhône-Alpes regional public health authorities (week hospital: two days and one night).
~At 6 and 18 months, one cardiology consultation
~At 12 and 24 months, consultations and acts realized by health professionals specialized (one hospital day care)"
16016569|NCT02763670|Other|"As usual  patient care management"|"Conventional management of heart failure patients is defined in the guide HAS (Haute Autorité de Santé) care course. Patient follow-up, however, is defined by the patient's physician and / or cardiologist at the waning of his hospitalization, according to the usual practice for patients with stage II, III or IV NYHA.
~According to these recommendations, the patient should see his cardiologist at least once a year.
~Usual practices are:
~An initial assessment and consultations with health professionals specialized in severe cardiac insufficiency during the hospitalization for cardiac insufficiency
~At 12 months, a cardiologic consultation. For the study, three evaluation points are programmed: two by phone at 6 and 18 months, two by a consultation at 24 months. This interview aimed to evaluate the number of hospitalization, consultations and acts realized by health professionals specialized (the information in the logbook)."
16016570|NCT02763657|Other|fMRI scanning|All participants are scanned while evaluating linear-order and set-inclusion reasoning problems
16016571|NCT02763644|Drug|LFG316 active drug|LFG316
16016572|NCT02763644|Other|Standard of care treatment|SoC (site specific)
16016573|NCT02763631|Other|Experimental: Treatment|Participants will be established on portable CPAP during the day with nasal pillows as an interface and requested to use it at least 8 hours/day.
16016574|NCT02763631|Other|Experimental: Run In Phase|Participants will undergo a run-in phase during which they will undergo baseline assessments. If they tolerate the portable CPAP and if their 6-MWT improves by more than 30m when performed on CPAP, they will be randomised into the trial.
16016575|NCT02763631|Other|Sham Comparator: Stand Care Arm|No change will be made to participants care
16016576|NCT02763618|Other|Neurofeedback|Neurofeedback theta/beta ratio training. See 'Neurofeedback theta/beta ratio training' in detailed study description.
16016577|NCT02763618|Other|Placebo Neurofeedback training|The placebo training will be a previously recorded Neurofeedback session of a participant in group A
16016578|NCT02763605|Other|no intervention|
16016579|NCT02763592|Drug|Lidocaine|The aim of this study is to evaluate the impact of 5% lidocaine medicated plaster on allodynic symptoms of localized neuropathic pain after knee surgery
16016580|NCT02763592|Other|placebo plaster|This is a randomized, placebo-controlled, double-blind, parallel-group clinical trial comparing 5% lidocaine medicated plaster (5LP) and placebo whether neuropathic pain symptoms (dynamic mechanical allodynia, pressure, hot and cold) have a different chronological improvement with 5LP compared to placebo. Pain intensity and pain relief, sleep and quality of life and osteoarthritis severity are also assessed.
16016581|NCT02763579|Drug|Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody|Atezolizumab intravenous infusion was administered at a dose of 1200 mg on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4) and maintenance phase (Cycle 5 onward).
16016582|NCT02763579|Drug|Carboplatin|Carboplatin intravenous infusion to achieve an initial target AUC of 5 mg/mL/min was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4).
16016583|NCT02763579|Drug|Etoposide|Etoposide intravenous infusion was administered at a dose of 100 mg/m^2 on Days 1, 2, and 3 of each 21-day cycle during the induction phase (Cycles 1-4).
16016584|NCT02763579|Drug|Placebo|Placebo intravenous infusion was administered on Day 1 of each 21-day cycle during the induction phase (Cycles 1-4) and maintenance phase (Cycle 5 onward).
16016590|NCT02763553|Dietary Supplement|Ketogenic Feed|A low-carbohydrate, high-fat feed designed to induce a ketotic state.
16016591|NCT02763553|Dietary Supplement|Standard Feed|Standard enteral feed used in critical care patients requiring nutrition via a nasogastric tube
16016592|NCT02763540|Procedure|Lung cryobiopsy|Transbronchial cryobiopsy
16016593|NCT02763527|Behavioral|Smoking reduction|A brief intervention on smoking reduction plus a smoking reduction leaflet
16016594|NCT02763527|Behavioral|Smoking Cessation|A brief advice on quitting plus a leaflet on smoking cessation
16016595|NCT02763514|Dietary Supplement|3 g PronovaPure 150:500 EE EU|
16016596|NCT02763514|Dietary Supplement|3 g PronovaPure 500:200 EE EU|
16016597|NCT02763514|Dietary Supplement|3 g Placebo|
16016598|NCT02763501|Procedure|closure of mesenteric defects|Closure of mesenteric defects by use of non-absorbable running sutures in RCT; and according to the choice of the surgeon in the non-RCT
16016599|NCT02763501|Procedure|non-closure of mesenteric defects|Mesenteric defects are left open
16016600|NCT02763488|Device|DelfiPTS tourniquet system|
16016601|NCT02763488|Other|Standard physical therapy|
16016602|NCT02763475|Drug|cyclophosphamide|60mg/kg by vein on day -6
16016603|NCT02763475|Drug|Fludarabine|25mg/m2 iv daily on day -5 to -1
16016604|NCT02763475|Procedure|NK cell infusion|"First allogeneic haploidentical NK cell iv. infusion: 5x10e7/kg, NK CD3-CD56+ immunophenotype, 24-48h after chemotherapy
~Second allogeneic haploidentical NK cell iv. infusion: up to 5x10e8/kg, NK CD3-CD56+immunophenotype, 7 days after the first infusion."
16016605|NCT02763475|Drug|IL-2|1x10^6 UI/m2 three times a week for two weeks from first NK infusion (day 0)
16016606|NCT02763449|Behavioral|Self-monitoing|Participants will self-monitor their physical activity level via activity monitors
16016607|NCT02763436|Procedure|physiological-based cord clamping|The cord of the newborn infant is clamped after establishing stable breathing efforts. The suspected time ranges from 2-4 minutes.
16016608|NCT02763423|Procedure|umbilical cord mesenchymal stem cell|allogeneic umbilical cord mesenchymal stem cell transplantation by intravenous injection
16016614|NCT02763371|Other|Dietary: high GI lunch|High GI: High-GI rice lunch ad libitum on test day 1 and low GI-rice lunch on test day 2. Water at libitum was constantly available on both days.
16016615|NCT02763371|Other|Dietary: low GI lunch|Low-GI: Low GI-rice lunch ad libitum on test day 1 and high GI-rice lunch on test day 2. Water at libitum was constantly available on both days.
16016616|NCT02763358|Device|Bite Counter|This study is a 15-week assessment of the possible utility of a wrist-worn device, the Bite Counter, in assisting the weight loss behavior change efforts of overweight and obese individuals. The Bite Counter tracks and analyzes wrist motions to identify those associated with taking bites of food and drinking beverages. It also has a step-counter feature. This study is designed to determine if using the Bite Counter with specific goals to reduce the numbers of bites and increase the numbers of steps will result in those changes.
16016617|NCT02763345|Device|Supporting LIFE electronic Community Case Management|The SL eCCM App is smartphone application developed to run on Android operating systems 3.0 Honeycomb and above. The SL eCCM App represents an electronic format of the WHO and UNICEFs paper-based CCM clinical decision rule, currently adopted as national policy in Malawi for assessing children presenting to village clinics with acute illness.The App includes a tap-sensitive breath counter for measuring breathing rate.
16016618|NCT02763345|Other|Standard care|
16016619|NCT02763332|Other|Upper trunk group (UTG)|This bandage was placed over the upper trapezius muscle.
16016620|NCT02763332|Other|Global trunk group (GTG)|This bandage was placed globally along the back
16016621|NCT02763319|Drug|Rituximab (RTX)|Rituximab: Dose: 375 mg/m2 IV
16016622|NCT02763319|Drug|Tafasitamab|Tafasitamab: Tafasitamab dose: 12 mg/kg intravenously (IV)
16016623|NCT02763319|Drug|Bendamustine (BEN)|
16016624|NCT02763306|Device|Dermal Cooling System|Treatment with dermal cooling system.
16016625|NCT02763293|Other|Manual Therapy|Non-manipulative treatment osteopathic techniques combined direct and indirect soft appropriate in patients with Crohn's disease
16016626|NCT02763280|Dietary Supplement|Ginseng extract 1g|Ginseng extract 1g, parallel design
16016627|NCT02763280|Dietary Supplement|Ginseng extract 3g|Ginseng extract 3g, parallel design
16016628|NCT02763280|Dietary Supplement|Placebo|placebo, parallel design
16016629|NCT02763267|Other|Oral glucose tolerance test|75 gram oral glucose tolerance test (fasting) at: Visit 1 (pregnant [4-14 weeks gestation] and nonpregnant women); Visit 2 (pregnant subjects only at 24-28 weeks gestation); Visit 3 (pregnant subjects only at 6-12 weeks postpartum)
16016630|NCT02763254|Biological|baltaleucel-T|Autologous EBV-specific T cells
16016631|NCT02763241|Drug|Cleanoze®|Cleanoze® consists of a powder made up of Sodium chloride and Sodium Bicarbonate. This powder when dissolved in 250 ml of water is closely resembles the content of a body fluid which normally baths the outside of the cells of the body. This fluid is isotonic solution.
16016632|NCT02763241|Drug|Saline (Syringe irrigation)|Nasal irrigation using 250 ml normal saline pushing into the nostril by 20 ml syringe
16016633|NCT02763228|Behavioral|Aerobic Training - Fixed Schedule|Supervised aerobic training for 40 minutes 3x/week for 20 weeks
16016634|NCT02763228|Behavioral|Resistance Training - Fixed Schedule|Supervised resistance training for 20 minutes 3x/week for 20 weeks
16016635|NCT02763228|Behavioral|Walking program|Unsupervised walking program 1-3 days/week for 52 weeks
16016636|NCT02763228|Behavioral|Aerobic Training - Flexible Schedule|Supervised aerobic training done on the participant's own schedule for 32 weeks
16016637|NCT02763228|Behavioral|Resistance Training - Flexible Schedule|Supervised resistance training done on the participant's own schedule for 32 weeks
16016638|NCT02763228|Behavioral|Successful Survivorship Health Education and Support Group|Support groups will be held for one hour 3x/week for 20 weeks. Topics will include, but are not limited, to long-term side effects of treatment, stress management, coping with fear and uncertainty, body image, sexuality, and spirituality.
16016639|NCT02763228|Behavioral|Flexible support groups|Participants will attend 1-3 weekly group sessions of their choosing for 32 weeks.
16016640|NCT02763215|Drug|Standard of Care Medications|Standard of care medications could include penicillamine, trientine, zinc, or a combination of a copper chelator and zinc.
16016641|NCT02763202|Other|CHS Transition Services|"The CHS Transition Services (CHS-TS) pathway includes the following seven components:
~(i) Introduction to CHS-TS process prior to discharge (ii) Hospital follow-up evaluation within 72 hours either in home with paramedicine or in the CHS-TS clinic (iii) Medication reconciliation by a pharmacist within 72 hours (iv) Weekly contact with care management team (v) Entry into the Heart Success Program if appropriate (vi) Access to 24/7 phone support, 24/7 paramedicine visits, and same day clinic scheduling (vii) Coordinated transition to the next appropriate care location after 30 days from time of discharge"
16016642|NCT02763189|Other|Expert mentoring|Experts will provide personalized instructional review on how to use the new device for changing endotracheal tubes.
16016643|NCT02763189|Other|Self-study|All subjects will receive self-study
16016644|NCT02763163|Behavioral|Sun exposure routine|
16016645|NCT02763150|Behavioral|Lifestyle intervention|Intervention group will receive comprehensive behavioral weight loss program.
16016646|NCT02763150|Other|Health Promotion|The health promotion group will receive education on healthy eating and activity
16016647|NCT02763137|Drug|Standard LD/CD|LD/CD will be administered at patient's usual dose and frequency during 8 hours interval
16016648|NCT02763137|Drug|Semi continuous intra-oral administration of LD/CD|Semi continuous intra-oral administration of standard LD/CD at a dose equal to the total dose of standard oral LD/CD that patients would normally consume over 8 hours period.
16016649|NCT02763124|Procedure|Verion-LenSx|The Verion-LenSx femtosecond laser system will be used to create one or two partial-depth corneal arcuate incisions
16016650|NCT02763111|Drug|BCD-085|
16016651|NCT02763111|Other|Placebo|
16016692|NCT02762890|Drug|Deep neuromuscular blockade|neuromuscular blockade will be performed using a continuous infusion of rocuronium. Post-tetanic count 1-2 will be maintained during surgery. After the end of surgery, sugammadex of 4 mg/kg will be administered to reverse neuromuscular blockade.
16016693|NCT02762890|Drug|Moderate neuromuscular blockade|neuromuscular blockade will be performed using a continuous infusion of rocuronium. Train-of-four 1-2 will be maintained during surgery. After the end of surgery, sugammadex of 2 mg/kg will be administered to reverse neuromuscular blockade.
16016652|NCT02763098|Drug|Remi 0.1|Intravenous (IV) administration of 0.5 mg Atropine prior to the induction, the patients randomly (by lot) received one of the three different doses (0.1 µg/kg/min) of remifentanil infusion for two minutes.After 2-minute remifentanil infusion, 0.5 mg/kg propofol was administered via IV route increasing the dose by 10 mg every 10 seconds; 0.5 mg/kg rocuronium was administered via IV route at the time of loss of eyelash reflex and consciousness. Two minutes later, intubation was performed. After recording the baseline values of heart rate, systolic arterial pressure, mean arterial pressure and diastolic arterial pressure, which were planned to be investigated, and administering atropine, a total of six measurements at one-minute intervals were performed until the time of intubation.
16016653|NCT02763098|Drug|Remi 0.2|.Intravenous (IV) administration of 0.5 mg Atropine prior to the induction, the patients randomly (by lot) received one of the three different doses (0.2 µg/kg/min) of remifentanil infusion for two minutes.After 2-minute remifentanil infusion, 0.5 mg/kg propofol was administered via IV route increasing the dose by 10 mg every 10 seconds; 0.5 mg/kg rocuronium was administered via IV route at the time of loss of eyelash reflex and consciousness. Two minutes later, intubation was performed. After recording the baseline values of heart rate, systolic arterial pressure, mean arterial pressure and diastolic arterial pressure, which were planned to be investigated, and administering atropine, a total of six measurements at one-minute intervals were performed until the time of intubation.
16016654|NCT02763098|Drug|Remi 0.3|Intravenous (IV) administration of 0.5 mg Atropine prior to the induction, the patients randomly (by lot) received one of the three different doses (0.3 µg/kg/min) of remifentanil infusion for two minutes.After 2-minute remifentanil infusion, 0.5 mg/kg propofol was administered via IV route increasing the dose by 10 mg every 10 seconds; 0.5 mg/kg rocuronium was administered via IV route at the time of loss of eyelash reflex and consciousness. Two minutes later, intubation was performed. After recording the baseline values of heart rate, systolic arterial pressure, mean arterial pressure and diastolic arterial pressure, which were planned to be investigated, and administering atropine, a total of six measurements at one-minute intervals were performed until the time of intubation.
16016655|NCT02763085|Device|Basic Filling Material|Tooth (teeth) affected by dental caries or with an existing defective filling will be restored using the materials listed (Basic Filling Material). Procedures will be done using local anesthesia. The cavity is excavated and filled according to the guidelines for ordinary restorative techniques.
16016656|NCT02763072|Device|Picosecond Q-switched Laser|One Enlighten treatment
16016657|NCT02763072|Device|KTP Laser|Up to four Excel V treatments
16016658|NCT02763059|Drug|Ibuprofen 600 mg|This group receives 1 hour before surgery 600 mg ibuprofen (and another 600 mg dose 6 hours after the first dose);
16016659|NCT02763059|Drug|Dexamethasone 4 mg|This group receives 1 hour before surgery 4 mg dexamethasone (and another 4 mg 6 hours after the first dose)
16016660|NCT02763059|Drug|Placebo|This group receives 1 hour before surgery placebo.
16016661|NCT02763059|Drug|Acetaminophen 1000 mg|A Rescue medication (1000 mg acetaminophen) was given to each patient who was instructed to take it if necessary.
16016662|NCT02763046|Drug|Secukinumab (AIN457) 150 mg s.c.|Induction: 5 x 150 mg secukinumab s.c. weekly Maintenance: 4 x 150 mg secukinumab s.c. every 4 weeks Delayed NSAID tapering (tapering following 4 weeks of secukinumab treatment).
16016663|NCT02763046|Drug|Secukinumab (AIN457) 150 mg s.c.|Induction: 5 x 150 mg secukinumab s.c. weekly Maintenance: 3 x 150 mg secukinumab s.c. every 4 weeks Early NSAID tapering (tapering at the start of secukinumab treatment).
16016664|NCT02763046|Drug|Placebo - Secukinumab (AIN457) 150 mg s.c.|Placebo for 15 weeks. From Week 16 on, 5 x 150 mg secukinumab s.c. weekly.
16016665|NCT02763033|Drug|Bob's Red Mill®|Standard bone marrow transplant (BMT) diet + potato-based starch
16016666|NCT02763033|Other|Starch Placebo|Standard bone marrow transplant (BMT) diet + corn-based starch
16016667|NCT02763020|Other|Fruit extracts high in polyphenols|
16016668|NCT02763020|Other|placebo|
16016669|NCT02763007|Drug|alogliptin+pioglitazone|alogliptin and pioglitazone add on metformin
16016670|NCT02763007|Drug|alogliptin|nesina add on metformin
16016671|NCT02763007|Drug|pioglitazone|actos add on metformin
16016672|NCT02762994|Drug|BCD-085|
16016673|NCT02762994|Other|Placebo|
16016674|NCT02762981|Drug|CORT125134 with nab-paclitaxel|CORT125134 is supplied as capsules for oral dosing. Nab-paclitaxel administered as an IV infusion.
16016675|NCT02762968|Dietary Supplement|Placebo|Placebo capsules similar to the experimental treatments.
16016676|NCT02762968|Dietary Supplement|HMB|Capsules containing calcium HMB.
16016677|NCT02762968|Dietary Supplement|BC30|Bacillus Coagulans GBI-30, 6086 (BC30) mixed in water.
16016678|NCT02762955|Biological|BCD-057|BCD-057 is biosimilar of adalimumab (produced by BIOCAD).
16016679|NCT02762955|Biological|Humira®|Humira is the original adalimumab (produced by F. Hoffman-La Roche)
16016680|NCT02762942|Drug|Misoprostol|Administration of 25 mcg of vaginal misoprostol every 4 hours up to 5 doses
16016681|NCT02762942|Device|Foley catheter|Insertion of a Foley catheter (16French) through the internal os for a maximum of 12 hours
16016682|NCT02762929|Drug|HTX-011A|
16016683|NCT02762929|Drug|Saline|
16016684|NCT02762929|Drug|HTX-011B|
16016685|NCT02762929|Drug|HTX-002|
16016686|NCT02762929|Drug|Bupivacaine Hydrochloride Injection|
16016687|NCT02762929|Drug|HTX-009|
16016688|NCT02762916|Other|Selfmanage with the help of telemedicine program|"The intervention group patients were not followed by the usual protocol, but it used the program CONTECI (and test different directions) to guide the patient monitoring.
~Both groups used antiplatelets and statines as usual protocol (these were not the interventions) We did not use drugs or device for the intervention, only a Telemedicine programme"
16016689|NCT02762903|Procedure|TSA with tenotomy technique|Standard procedure: Utilization of tenotomy for mobilization of subscapularis during total shoulder arthroplasty (TSA). The subscapularis tendon is incised close to its attachment on the humerus. The Tendon is repaired with sutures.
16016690|NCT02762903|Procedure|TSA with lesser tuberosity osteotomy technique|Standard procedure: Utilization of the osteotomy to mobilize the subscapularis during TSA. A small fleck of bone is removed from humerus, the subscapularis tendon is still attached. The fleck of bone is reattached with sutures.
16016691|NCT02762903|Device|Shoulder prosthesis|"Standard procedure: Total shoulder arthroplasty replaces both components of the ball and socket joint with a metal device."
16016695|NCT02762864|Drug|ticagrelor|Antiplatelet therapy approved for ACS. Antagonist of P2Y12 and inhibitor of adenosine diphosphate (ADP)-induced platelet aggregation.
16016696|NCT02762864|Drug|Comparator|dual antiplatelet therapy with clopidogrel 75 mg and aspirin 100 mg daily will be continued for 6 months after the procedure for patient followed with single antiplatelet therapy with clopidogrel 75 mg daily throughout the follow-up period.
16016697|NCT02762851|Other|Sterile saline|0.5 ml dose injected intramuscularly
16016698|NCT02762851|Drug|inactivated trivalent influenza vaccine|0.5 ml dose injected intramuscularly
16016699|NCT02762838|Biological|BCD-055|BCD-055 is infliximab biosimilar
16016700|NCT02762838|Biological|Remicade®|
16016701|NCT02762838|Drug|Methotrexate|All patients will receive methotrexate in a dose from 10 to 25 mg per week.
16016702|NCT02762838|Drug|Folic acid|All patients will receive folic acid in a dose of 5 mg per week.
16016703|NCT02762825|Behavioral|HIIT|HIIT will consist of 4 min of higher intensity work set at 90% of heart rate reserve, based on peak heart rate from CPX test. Recovery intervals will be 3-4 min in duration and set at 60-70% of heart rate reserve. Resistance training will be performed once per week.
16016704|NCT02762825|Behavioral|MCT|MCT will consist of aerobic exercise performed 3 times per week for 30 min each session, at an intensity of 60-80% of heart rate reserve, based on peak heart rate from CPX test.
16016705|NCT02762812|Biological|BCD-055|
16016706|NCT02762812|Biological|Remicade®|
16016707|NCT02762799|Biological|Leucostim®|Leucostim® is filgrastim biosimilar.
16016708|NCT02762799|Biological|Neupogen®|
16016709|NCT02762786|Behavioral|musical training|The subjects in the experimental group will receive weekly one-hour lessons on musical training for 12 weeks, conducted by the Music Children Foundation.
16016710|NCT02762773|Procedure|non-dissection of inferior rectus sheath|Non-dissection of inferior rectus sheath
16016711|NCT02762773|Procedure|control|Dissection of inferior and superior aspect of the rectus sheath
16016712|NCT02762760|Biological|AMPION™|AMPION™, up to 3 mL, single intra-articular injection. Ampion is the ultrafiltrate of 5% HSA.
16016713|NCT02762760|Biological|Saline|Saline placebo, up to 3 mL, single intra-articular injection. Saline used as the comparator is 0.9% Sodium Chloride
16016714|NCT02762747|Procedure|preperitoneal suction drainage|preperitoneal suction drainage after laparoscopic totally extra-peritoneal hernioplasty for inguinal hernia
16016715|NCT02762734|Other|MEDIA|"The intervention for the group MEDIA is a keeping in touch intervention through sending of SMS (or mail or other new media). The patient will receive 6 SMS (or mail or other new media) during 6 months after the suicide attempt. The first one 7 days after the suicide attempt and the last one after 6 months. The first SMS (or mail or other new media) is sent soon after the suicide attempt because studies on adult suicide attempters underline the importance of an early start for the connectedness measures. The text message are evolving in time, and are adapted to the genre of the adolescent."
16016716|NCT02762708|Procedure|Roux-en-Y Gastric Bypass (RYGB)|Subjects will be studied prior to surgical intervention and 12 weeks post surgery. Subjects in surgical arm will start diet intervention after surgery. Follow up with dietary will be per standard of care following RYGB surgery.
16016717|NCT02762708|Behavioral|Caloric Restriction|Subjects participating in caloric arm of this study will be asked to consume an identical diet that is controlled for caloric content and macronutrient composition. This is identical to that consumed by patient undergoing RYGB. Subjects in the caloric restriction arm will start the diet after the screening visit. Compliance will be monitored by alternating weekly meetings with a clinical psychologist and dietician.
16016718|NCT02762708|Drug|Exendin-9,39|"A subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called incretins that are produced by the gut in health and in larger quantities after gastric bypass surgery."
16016719|NCT02762708|Drug|Normal Saline|"subset of 4 subjects who have undergone RYGB surgery will be studied 4 weeks after surgery. Subjects will be randomized to receive an infusion of either Exendin-9,39 or normal saline. Exendin-9,39 blocks the action of specific hormones called incretins that are produced by the gut in health and in larger quantities after gastric bypass surgery."
16016720|NCT02762695|Other|Case Management|"A model of health care for chronic patients, based on Case Management and guided by a nurse which targets the patient´s risk.
~The core elements of this strategy are: a. processes to identify specific population and their risk; b. evidence-based practice guidelines according to risk (higher risk, more interventions and monitoring by a nurse, lower risk, higher emphasis on self-care); c. Practice models based on collaboration between health team members leaded by a nurse; d. self-management education for patients; e. monitoring patients face to face or by telephone to ensure to follow the care program (blood test, medical consultation, for example); e. measurement of process and outcomes."
16016721|NCT02762695|Other|Usual Care|Usual Care at Primary Health Care Center
16016722|NCT02762669|Drug|Oxytocin|Oxytocin, 10-7mol/L to 10-5mol/L
16016723|NCT02762656|Drug|Lidocaine|Lidocaine drip during surgery
16016724|NCT02762643|Drug|DP-R213|Investigational product is prescribed to all of randomized subjects
16016725|NCT02762643|Drug|Raloxifene|Investigational product is prescribed to all of randomized subjects
16016726|NCT02762643|Drug|Cholecaliferol|Investigational product is prescribed to all of randomized subjects
16016727|NCT02762630|Device|Carestream Health Inc. weight bearing cone beam CT scanner|
16016728|NCT02762617|Drug|Tenofovir disoproxil fumarate intravaginal ring|The TDF IVR is formulated using preformed flexible tubing, comprised of biomedical medical grade hydrophilic, aliphatic polyurethane, and an inner core compartment comprised of 86% (w/w) TDF and 14% (w/w) sodium chloride. The ring will be inserted by the study clinician and worn for 28 day intervals for a total of 3 months (84 days). The ring will be removed and replaced with a new ring at each 28 day interval.
16016729|NCT02762617|Drug|Placebo intravaginal ring (IVR)|The Placebo IVR is formulated using preformed flexible tubing, comprised of biomedical medical grade hydrophilic, aliphatic polyurethane, and an inner core compartment comprised of sodium chloride. The ring will be inserted by the study clinician and worn for 28 day intervals for a total of 3 months (84 days). The ring will be removed and replaced with a new ring at each 28 day interval.
16016829|NCT02761720|Other|No Intervention|
16016730|NCT02762604|Behavioral|Imagined Gait Intervention|Phone-based imagined gait intervention: participants will be called by the experimenter three times a week and be asked to imagine walking, imagine talking and imagine walking-while-talking. They will also be asked to rate their visual and kinesthetic qualities of their images on a 1-5 scale following each trial.
16016731|NCT02762604|Behavioral|Visual Imagery Intervention|Phone-based visual imagery intervention: participants will be called three times a week by the experimenter and be asked to imagine concrete objects (e.g. octopus, teapot, and shovel). They will also be asked to rate their visual qualities of their images on a 1-5 scale following each trial.
16016732|NCT02762591|Drug|Pimavanserin tartrate|Pimavanserin tartrate 40 mg, tablet, taken as two 20 mg tablets, once daily by mouth
16016733|NCT02762578|Drug|insulin degludec/insulin aspart|Twice daily subcutaneous (sc, under the skin) injection.
16016734|NCT02762578|Drug|biphasic insulin aspart|Twice daily subcutaneous (sc, under the skin) injection.
16016735|NCT02762565|Device|PEFS system (Product Name: Intelligent Breast Exam™ or iBE™|
16016736|NCT02762552|Device|Transcranial-holter monitoring|Transcranial holter with an 4 hour-recording
16016737|NCT02762539|Drug|omega-3 enriched SMOF lipid emusion|
16016738|NCT02762526|Procedure|Lipoabdominoplasty|
16016739|NCT02762513|Drug|Axitinib|
16016740|NCT02762500|Drug|LYC-30937-EC|
16016741|NCT02762500|Drug|Placebo|
16016742|NCT02762487|Device|The LINX® Reflux Management System|The LINX device is a permanent implant placed at the area of the lower esophageal sphincter (LES) and is designed to augment a weak LES and minimize or eliminate GERD-related symptoms.
16016743|NCT02762474|Drug|nab-paclitaxel group|Weekly Regimens of Nab-paclitaxel Plus Cispaltin Combined With Concurrent IMRT
16016744|NCT02762461|Procedure|IVF or ICSI|
16016745|NCT02762448|Drug|Daclatasvir+ Asunaprevir|HCV clearance and complete regression of NHL by ASV+ DCV
16016746|NCT02762435|Other|sham|light touch at established points on hand and wrist
16016747|NCT02762435|Other|control|no contact with the subject
16016748|NCT02762435|Other|acupressure|moderate pressure at established points on hand and wrist
16016749|NCT02762422|Other|Phlebotomy|Removal of 500 cc of blood via forearm vein
16016750|NCT02762409|Other|experimental|corresponding to surviving individuals of a hospitalization in intensive care in a department having set up the program of reduction of the discomforts collected by the patients of intensive care during a minimal period of 5 months. The program is so defined as factor of exposure and supposed protector of development of anxio-depressive disorders.These patients will have been included in the study IPREA3 in 17 centers of the interventional group of the study IPREA3 during the months of April, 2015 and October, 2015
16016751|NCT02762409|Other|control|"The patients not exposed in the supposed factor protector of development of anxio-depressive disorders will be constituted by the patients estimated in the study IPREA3 corresponding to surviving individuals of a hospitalization in intensive care in a department having never operated the program of reduction of the discomforts collected by the patients of intensive care. These patients will have been included in the study IPREA3 in 17 centers of the group control some study IPREA3 during October 2014 and April, 2015"
16016752|NCT02762383|Drug|Peginterferon Alfa-2|Peginterferon alfa-2a will be administered as 90 micrograms (mcg) via subcutaneous (SC) injection once weekly.
16016753|NCT02762370|Drug|FX006 32 mg|Single 5 mL IA injection
16016754|NCT02762370|Drug|TCA IR 40 mg|Single 1 mL IA injection
16016755|NCT02762357|Device|Novosyn® Quick|Episiotomy closure
16016756|NCT02762344|Drug|heparin|routinary heparin administration during coronary angiography/PCI
16016757|NCT02762331|Drug|Ascorbic Acid|Comparing safety and efficacy of IV Vitamin C in CABG patients
16016758|NCT02762331|Drug|Placebo|Placebo intervention
16016759|NCT02762318|Other|Samples With DNA|"After consenting, all subjects have to undergo the following procedures:
~Up to 25 ml of blood will be withdrawn. If for any reason, the blood sample cannot be obtained, a swab will be applied to the inside of the cheek to obtain saliva.
~A questionnaire will be used to collect information about individual A routine physical exam will be performed. The subject's medical record will be reviewed To well document some of the specific phenotypes and conditions, physicians might take photographs of the affected body area.
~For secondary subjects (relatives or family members), normal examination and routine lab tests/ imagining will be done if needed as per the related standard care."
16016760|NCT02762305|Other|RSVP Bone Builders Group Exercise|
16016761|NCT02762292|Device|Measurement of work of breathing using indirect calorimeter|"Preparation:
~Patient baseline characteristics will be collected.
~Connection of the Indirect Calorimeter to the respiratory circuit.
~Nasogastric tube installation: a specific modified Neurally Adjusted Ventilatory Assist (NAVA) catheter equipped with both microelectrodes for Electrical Activity of the diaphragme (EAdi) monitoring and an esophageal balloon (for esophageal pressure (PES) monitoring) will be installed.
~Simultaneous recordings of: Oxygen Consumption (VO2) and Energy Expenditure (EE); Esophageal Pressure (PES), Airway Pressure (PAW), respiratory volume and flow; EAdi during (i) Conventional mechanical ventilation (ii) Spontaneous Breathing Trial in Continuous Positive Airway Pressure and (iii) Second period of Conventional mechanical ventilation with the same ventilator parameters set in STEP 1.
~End of the physiological recordings. Collection of Pediatric Intensive Care Unit (PICU) outcome of patients."
16016762|NCT02762279|Other|esophageal and pleural pressure measurement|Esophageal pressure will be monitored by a dedicated catheter and pleural pressure will be measured into the chest tube already in place
16016763|NCT02762266|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
16016764|NCT02762266|Procedure|Transarterial Chemoembolization|Undergo TACE
16016765|NCT02762266|Drug|embolic agent|". Acceptable embolic agents include:
~Gelatin sponge (gelfoam)
~Polyvinyl alcohol (PVA) particles
~Microspheres / Embolic beads"
16016766|NCT02762266|Drug|lipiodol|
16016767|NCT02762253|Drug|Riboflavin drops|Riboflavin drops were used every 2 minutes for 30 minutes on the cornea then exposed to 5 minutes of Ultraviolet light at an intensity of 18mW/cm2
16016768|NCT02762240|Other|DHQP 2016|DHQP for general practice consists of 16 standards with associated indicators within the following areas: 1. Quality and patient safety, 2. Patient safety critical standards, 3. Good patient continuity of care, 4. Management and organisation.
16016887|NCT02761278|Procedure|Endometrial biopsy|
16017412|NCT02757560|Other|MUFA diet|MUFA versus control diet
16016769|NCT02762240|Other|DHQP 2018|DHQP for general practice consists of 16 standards with associated indicators within the following areas: 1. Quality and patient safety, 2. Patient safety critical standards, 3. Good patient continuity of care, 4. Management and organisation.
16016770|NCT02762227|Device|Abdominal high resolution CT|CT examinations were performed using a 64-slice CT scanner. Arterial phase scanning was triggered by bolus tracking technique after 100 to 120 mL nonionic contrast material was injected through the antecubital vein. With a delay of 60 and 140 s after the beginning of contrast medium injection, portal venous and equilibrium phase image scanning were followed.
16016771|NCT02762227|Device|Contrast-enhanced ultrasonography (CEUS)|CEUS examinations were performed using a Philips iU 22 scanner with a 1-5 MHz（Mega Hertz, MHz）vector transducer. Traditional transabdominal ultrasound and CEUS were performed by the same investigator, one with more than 3 years experiences in CEUS. Traditional ultrasound was used initially to locate the lesion. The plane with the bottom of the lesion was selected for further examination. When multiple lesions were existed, the largest one was selected to evaluate. The target was placed in the center of the screen and was kept stable. Pulse inversion harmonic imaging with an index of 0.06 was used in CEUS examination. SonoVue, which contained sulfur hexafluoride microbubbles, was used as the contrast agent.
16016772|NCT02762227|Procedure|Cholecystectomy|Cholecystectomy is performed by method of either laparoscopic cholecystectomy or open cholecystectomy.
16016773|NCT02762214|Device|Clermont-Ferrand Uterine Manipulator|"Pelvic cytology is obtained before starting surgical procedures (washing number 1).
~After tubal coagulation, Clermont-Ferrand Uterine Manipulator is installed inside the uterus. At the end of the hysterectomy, after colporrhaphy, a second cytology is obtained (washing number 2)"
16016774|NCT02762214|Other|No uterine Manipulator|"Pelvic cytology is obtained before starting surgical procedures (washing number 1). None uterine manipulator is used and the cervix is closed with a cross stitch.
~Tubal coagulation, At the end of the hysterectomy, after colporrhaphy, a second cytology is obtained (washing number 2)"
16016775|NCT02762201|Procedure|PASI|"Implant-secured removable partial denture will be delivered in 2 large steps: implant delivery followed by denture delivery.
~Implant delivery will take 4 dental consultations : a pre-implant study at Day14 after inclusion, the surgical implant insertion at D28 after inclusion, stitches removal at D35 after inclusion, and finally functional implant delivery between 3 or 6 month after surgery (to allow implant osteointegration).
~Denture delivery will take 6 weekly dental consultations between Week 3 and Week 8 after the functional implant delivery."
16016776|NCT02762201|Procedure|PAC|Metalic standard removable partial denture, the standard treatment, will be delivered in 4 steps at Day 7, D14, D21, D28 after inclusion, as classically.
16016777|NCT02762188|Device|Genotype analysis|"After signing informed consent, a blood sample is taken and DNA extracted according to standard procedures. The samples are genotyped with the Mass Array iPlex Gold. Processing of the data is done using the previously described protocol by Lambrechts and co.
~Statistical analysis will be done to evaluate the association between the different genetic variants and the clinical outcomes collected during the standard of care follow-up for ARMD."
16016778|NCT02762149|Device|Nerve stimulator|The nerve stimulator (Stimpod NMS 450: Xavant technology (PTY) Ltd; Pretoria, South Africa or similar nerve stimulator) will be connected to the epidural catheter through an adapter (Johans ECG Adapter, Arrow International Inc., Reading). The epidural catheter and the adapter will be primed with a standard volume of 3 ml of sterile normal saline to allow for effective electrical conduction. Secured connections and avoidance of any air within in the system must be ensured to avoid high impedance in the circuit, which could result in false negatives. The cathode terminal of the stimulator will then be attached to the metal hub of the adapter and the anode terminal will be connected to the electrode placed over the deltoid muscle.
16016779|NCT02762136|Drug|placebo|
16016780|NCT02762136|Drug|Xiang-sha-liu-jun granules|The Xiang-sha-liu-jun granules comprises 10 herbs, Astragalus membranaceus (Huangqi) 15g, Codonopsis pilosula (Dangshen) 15 g, fructus aurantii (Zhiqiao) 15g, fructus amomi(Sharen) etc
16016781|NCT02762123|Drug|BMS-986142 200mg|
16016782|NCT02762123|Drug|BMS Drug-drug interaction cocktail (montelukast, flurbiprofen, omeprazole, midazolam, and digoxin)|
16016783|NCT02762123|Drug|BMS-986142 350mg|
16016784|NCT02762097|Procedure|polypectomy|. During the second visit after she consents to removal of polyp revealed on prior saline sonography, a dilatation and curettage would be performed under ultrasound guidance and after successful removal of polyp (polypectomy) saline sonography would be repeated to ensure completeness of removal.
16016785|NCT02762097|Procedure|saline sonography|saline infusion sonography (SIS) on 8th to 11th day of menstrual cycle. On the day of admission SIS will be performed in an outpatient setting .Taking all aseptic measures a speculum will be inserted vaginally and up to 20 ml of sterile saline solution will be infused into the uterine cavity through a cervical foley's catheter of 5 french to distend the endometrial cavity. A transvaginal transducer will be used to scan the uterine cavity. In case the patient has polyps she would be offered removal under general anaesthesia on a subsequent visit as a day case procedure.
16016786|NCT02762097|Drug|normal saline|Normal saline would be injected into uterine cavity to delineate defects
16016787|NCT02762084|Drug|Patidegib|
16016788|NCT02762084|Drug|Vehicle gel|
16016789|NCT02762071|Drug|Liposomal bupivacaine|Patients in this group will receive a periarticular injection containing liposomal bupivacaine during surgery. The injection will be administered by the surgeon.
16016790|NCT02762071|Drug|Interscalene Nerve Block|Patients in this group will receive an interscalene nerve block containing the local anesthetic ropivacaine prior to surgery. The nerve block will be administered by a fellowship-trained anesthesiologist.
16016791|NCT02762058|Device|Virtual Reality Mirror Therapy|Virtual Reality Mirror Therapy system using occulus rift as virtual headset and kinect as motion tracking sensor.
16016792|NCT02762058|Procedure|Traditional Mirror Therapy|Traditional Mirror Therapy system consisting of a mirror in which patients view their healthy limb over the affected to trick brain during dual motion tasks. This therapy has been shown to improve upper extremity function in patients with acquired brain injury.
16016793|NCT02762045|Biological|Ad5-gag|Ad5-gag is used as vaccine in all arms.
16016794|NCT02762045|Biological|Placebo|Preservation Solution is used as control in all arms.
16016795|NCT02762032|Dietary Supplement|PrimaVie Herbal Supplement 125|125 mg to take BID for 14 weeks in Arm 1
16016796|NCT02762032|Dietary Supplement|PrimaVie Herbal Supplement 250|250 mg to take BID for 14 weeks in Arm 2
16016798|NCT02762019|Device|Laser therapy|Treatment with K-Laser Cube3 during 4 consecutive days, with the following protocol: 660-970 nm wavelength, 3,2W mean power (6.4W pulsating at 50%), 3'51'' duration, 1-20000 Hz frequency, and 1 cm2 spot size. Laser application was performed all over the oral cavity.
16016799|NCT02762019|Device|Sham therapy|Only the laser pointer movement, without laser activation, during 4 consecutive days, all over the oral cavity.
16016800|NCT02762006|Drug|Durvalumab|Durvalumab is a programmed cell death ligand-1 monoclonal antibody which has demonstrated anti-tumor efficacy renal cell carcinoma and other malignancies via activation of the immune system.
16016801|NCT02762006|Drug|Tremelimumab|Tremelimumab is a CTLA-4 monoclonal antibody.
16016802|NCT02761993|Biological|ST266|1X ST266 applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. ST266 will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
16016803|NCT02761993|Drug|Saline (0.9% NaCl)|Saline applied in a dose of 20 microliters per tooth. Total daily dose will be less than 1 milliliter. Saline will be applied directly to the marginal gingiva around each tooth (buccal and lingual).
16016804|NCT02761980|Drug|Ibuprofen 250 mg / Acetaminophen 500 mg|Ibuprofen 250 mg / Acetaminophen 500 mg
16016805|NCT02761980|Drug|Ibuprofen 250 mg|Ibuprofen 250 mg
16016806|NCT02761980|Drug|Acetaminophen 500 mg|1 APAP 500 mg caplet
16016807|NCT02761980|Drug|Placebo|Placebo tablet
16016808|NCT02761967|Behavioral|Physical activity|Women from the 20th week of moderate physical exercise performed in water character designed following the guidelines in the SWEP method will end in week 37 of gestation. After the postpartum period, women begin a program based on postpartum recovery exercises Fitness Low Pressure method 12-week, 3 days a week, in sessions of 60 minutes.
16016809|NCT02761928|Other|Beighton score for hypermobility|The beighton score is a 9 point score of flexibility, used for patients with disorders of collagen.
16016810|NCT02761915|Other|Leukapheresis|
16016811|NCT02761915|Drug|Cyclophosphamide|
16016812|NCT02761915|Drug|Fludarabine|
16016813|NCT02761915|Genetic|1RG-CART|
16016814|NCT02761889|Radiation|IGRT 45 Gy in 5 fractions of 9 Gy|Previously untreated patients with prostate cancer will be treated with 45 Gy in five fractions of 9 Gy over 5 consecutive days.
16016815|NCT02761889|Procedure|Image-guided, volumetric intensity-modulated arc radiotherapy (IGRT-VMAT)|Patients enrolled in the study will undergo IGRT-VMAT with state-of-the-art treatment-planning and quality assurance procedures with emphasis on normal tissue sparing and delivery accuracy via the use of devices that ensure stability and beam location reproducibility.
16016816|NCT02761889|Device|Rectal balloon with air filling|A rectal balloon with air filling will be used for prostate target immobilization and anatomical reproducibility.
16016817|NCT02761889|Device|Urethral catheter loaded with beacon transponders|A urethral catheter loaded with beacon transponders will be used to ensure set-up reproducibility and online target tracking.
16016818|NCT02761876|Behavioral|Mentor farmer training (Malawi)|Mentor farmers, 1 man, 1 woman, from each village will participate in a field visit to and training by existing mentor farmers in Malawi. Only the intervention arm of this study will receive mentor farmer training in Malawi, delayed intervention arm will receive mentor farmer training from farmers participating in the initial intervention in Tanzania.
16016819|NCT02761876|Behavioral|Mentor farmer training (Singida, Tanzania)|Mentor farmers will receive training in Singida, Tanzania on agroecology practices, climate change, nutrition, and gender equality. Intervention villages will receive training in 2016. Delayed intervention villages will receive training in 2019.
16016820|NCT02761876|Behavioral|Mentor farmer visits and facilitation|Mentor farmers will conduct monthly visits to participating households and support the households in conducting experimentation with agroecological practices and/or new behavior regarding nutrition and gender equality. Quarterly meetings among farmers within each village will be held to discuss progress and challenges of household experimentations. Intervention households will receive support and facilitation for approximately 2 years. Delayed intervention households will receive support and facilitation for approximately 6 months after end line survey.
16016821|NCT02761863|Other|CD 74, VEGF detection|"All MPM samples will be subjected to immunohistochemistry with CD74 and VEGF antibodies.
~The VEGF will be scored using a 0-3 scoring system to represent the percentage of cytoplasmic positively stained cells in the tumor portion, as follows: 0-10%, 11-30%, 31-60% and 61-100% positive staining correspond to score 0, 1, 2 and 3 respectively. Both CD74 and VEGF immunohistochemical markers will be furtherly categorized in the statistical analyses as none (0)/low (1) vs medium (2)/high expression(3).
~The CD74 expression will be recorded in the tumor and the stroma semiquantitatively using the histoscore method using four representative fields with the final score resulting from the percentage of tumor cells staining positively multiplied by the staining intensity grade."
16016822|NCT02761837|Behavioral|IVR call/text|For patients under filling their inhaled corticosteroid or overusing B-agonist, the patient is contacted via IVR call or text
16016823|NCT02761837|Behavioral|Email|Patients under filling their inhaled corticosteroid or overusing B-agonist, the the patient is contacted via email
16016824|NCT02761824|Other|Camp Discovery|Activities included physical, social, emotional, sensory and spiritual activities.
16016825|NCT02761811|Device|SyMapCath I™ catheter and SYMPIONEER S1™ Stimulator/Generator|Radiofrequency ablation of renal arterial sympathetic nerves
16016826|NCT02761798|Device|Automated Mobile Interactive Audiometer|iPad game
16016827|NCT02761746|Behavioral|MESA|MESA is tailored based on how important and how confident the participant feels about taking medications as prescribed. If the participant does not believe taking medications is important, they engage in a decisional balance exercise. If the participant believes taking medications is important, they move directly to confidence modules and goal setting. If the participant does not feel confident about taking medications, they engage in activities to boost self-efficacy. Participants are also offered personalized feedback regarding immune status and HIV knowledge with actual adherence feedback provided in the second session. Finally, goal setting is an option, and feedback regarding adherence behavior over the previous month.
16016828|NCT02761733|Behavioral|Moving Patient Outcomes toward Wellness and Recovery (mPOWR)|An mPOWR intervention and toolkit that consists of strategies, prompts, and decision aids designed to foster patient involvement in treatment. The mPOWR intervention includes a questionnaire that assesses quality of life and consumer functioning for use in the development of consumer-centered goals and outcomes within the mPOWR intervention.
16016830|NCT02761707|Other|Electrical Brainstem Responses|Eye blink responses will be induced using standard stimulating electrodes employed in surface electromyography (EMG). The subjects will recline with their eyes gently closed. Sticky electrodes will be placed to the left and below the left eye. 6 different facial regions will be stimulated. The electrical stimulation will be kept constant during the test sessions. To prevent habituation, the stimuli will be delivered randomly at intervals of 45-60 sec. Four 0.2 msec pulses will be presented. In some cases, paired pulse stimulation will be performed, and a conditioning stimulus will be applied to the target facial regions at the following intervals: 10, 200, 400, 600 and 800 msec. 4 pulses will be presented at each stimulus interval with randomized interval and pulse sequences.
16016831|NCT02761707|Other|Olfactory Tests|Olfactory testing will be performed using standard tests. The University of Pennsylvania Smell Identification Test (UPSIT) assesses a subjects ability to identify odors in a forced choice format. The Snap and Sniff Threshold Test provides a threshold measure of phenyl ethyl alcohol. Short-term odor memory will be assessed using a standardized 12-item four-alternative forced-choice Odor Memory Test. This non-lexical test employs 10-, 30-, and 60-second delay intervals between the presentation of the target odorant and the first of four successively presented odors from which the target is to be selected.
16016832|NCT02761707|Other|Visual Deprivation|During a 2-hour visual deprivation period, subjects will wear comfortable light-tight goggles with lenses that have been blackened by flat black paint. Subjects will be given the opportunity to recline comfortable in a padded reclining chair during this time.
16016833|NCT02761707|Other|Peripheral Nerve Stimulation|Electrical stimulation will be applied to a nerve of your arm. Sticky electrode pads will also be placed on a hand muscle. You will receive electrical stimulations that lasts less than a second. The stimulations will make your muscle twitch.
16016837|NCT02761681|Behavioral|ACT-CL Web-based guided self-help|
16016838|NCT02761681|Behavioral|Control Web-based guided self-help|
16016839|NCT02761668|Procedure|ParS+Ortho 4W|Orthodontics 4 weeks post surgical
16016840|NCT02761668|Procedure|ParS+Ortho 6M|Orthodontics 6 months post surgical
16016841|NCT02761655|Behavioral|Memory Strategies|Memory strategies on encoding retention, retrieval, execution and monitoring
16016842|NCT02761642|Drug|Epoetin Beta|All participants will receive epoetin beta at a dose of 30000 International Units (IU) as SC injection once every week for a total of 12 weeks. Adjustments in the dose will be implemented based on the participant's blood hemoglobin levels.
16016843|NCT02761629|Drug|Peg-Interferon Alpha-2A|Peg-IFN-Alpha-2A will be administered at 180 micrograms (mcg) once weekly via subcutaneous injection.
16016844|NCT02761629|Drug|Ribavirin|Ribavirin will be administered as either 1000 milligrams (mg) (2*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing less than (<) 75 kilograms (kg) or as 1200 mg (3*200 mg tablets in morning and 3*200 mg tablets in evening) for participants weighing greater than or equal to (>/=) 75 kg.
16016845|NCT02761616|Other|eBC treated participants|No intervention administered in this retrospective observational study.
16016846|NCT02761603|Behavioral|Healthy Aging Practice-centered Instruction (HAPI)|"Sessions will include interactive activities derived from the CDC's Program to Encourage Active and Rewarding LiveS (PEARLS) and will include lectures based on health-related topics from presentations given by experts as part of the UC San Diego Stein Institute of Aging's Successful Aging project. The PEARLS Problem Solving Treatment (PST) group discussions will be facilitated by a trained instructor in order for participants to identify problems or barriers they have in engaging in healthy behaviors relevant to each of 12 topic areas (e.g. sleep, nutrition, mental health, social support, bone health, diabetes prevention, cognitive wellness, and resilience). Each session will be composed of: Successful Aging video (45 min), discussion (40 min), and identifying problem solving strategies (25 min) with a homework assignment each week, for a total of 24 hours of in-class instruction and discussion."
16016847|NCT02761603|Behavioral|Tai Chi (CHI)|Sessions will include expert instruction in the brief Yang-style 8-form Tai Chi meditative movements. Each class will include a 10-minute warm-up and cool-down plus 40 minutes of Tai Chi instruction and or practice, for a total of 24 hours of in-class instruction
16016848|NCT02761590|Other|Circuit training protocol|The construction of own model of periodization to be used complies with the biological principle of interdependence volume vs. intensity, and duration of 14 weeks, proposing a week of recuperative exercises after two weeks of stress, gradually increasing the intensity with respective volume settings. This model is based on the concepts described by Turner et al. which concludes in favor of the organization of training adapted to the reality of the public to be trained.
16016849|NCT02761577|Drug|Sodium bicarbonate|3 mL/kg/hour of Sodium bicarbonate, an hour prior to angiography and 1 mL/kg/hour, within six hours after angiography
16016850|NCT02761577|Drug|N-acetylcysteine|N-acetylcysteine (1200 mg twice a day, IV (in vein) ) one day before angiography, on the day of the angiography, and one day after the diagnostic procedure
16016851|NCT02761564|Other|Red blood cell tranfusion|Red blood cell transfusion according to transfusion guidelines.
16016852|NCT02761564|Other|ScvO2 measure|ScvO2 (oximetry) is measured at the distal lumen of the central venous catheter placed in the superior vena cava. Transfusion is performed if ScvO2 is inferior or equal to 65%.
16016853|NCT02761551|Behavioral|Reminder notifications via autodialer|
16016854|NCT02761538|Behavioral|AVIITAM|"The purpose of the project is to test the medico economic impact related to the utilization of the Aviitam online platform in primary care.
~.
~."
16016888|NCT02761265|Procedure|Surgical intervention|Surgery to correct spinal deformity
16017413|NCT02757560|Other|CARB diet|CARB versus control diet
16016855|NCT02761525|Other|silver nanoparticles|Allocation was randomized. Evaluate the effectiveness of silver nanoparticles incorporated into an innocuous gel and dished in oral mucosa surface to then compare with another innocuous gel without silver nanoparticles to reduce microbial colony forming units of pathogenic potential.
16016856|NCT02761525|Other|placebo|Compare with another innocuous gel without silver nanoparticles to reduce microbial colony forming units of pathogenic potential using the same procedure to dished the gel.
16016857|NCT02761512|Drug|CJ-12420 50 mg QD|CJ-12420 50 mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose gastric ulcer is not endoscopically healed(S1 or S2 stage) at Week 4, subjects will receive additional 4 weeks treatment of CJ-12420 50 mg.
16016858|NCT02761512|Drug|CJ-12420 100 mg QD|CJ-12420 100 mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose gastric ulcer is not endoscopically healed(S1 or S2 stage) at Week 4, subjects will receive additional 4 weeks treatment of CJ-12420 100 mg.
16016859|NCT02761512|Drug|Lansoprazole 30 mg QD|Lansoprazole 30 mg capsule will be orally administered, once daily, for up to 8 weeks. For subjects whose gastric ulcer is not endoscopically healed(S1 or S2 stage) at Week 4, subjects will receive additional 4 weeks treatment of Lansoprazole 30 mg.
16016861|NCT02761486|Drug|Aspirin|325mg aspirin per day
16016862|NCT02761486|Drug|Placebo|placebo in matching capsules
16016863|NCT02761473|Other|skin biopsy|A skin biopsy will be obtained from a typical UP lesion in affected patients
16016864|NCT02761473|Other|blood draw|Blood will be obtained from subjects, parents and unaffected siblings
16016865|NCT02761460|Drug|PEG-rhG-CSF|PEG-rhG-CSF 6mg is given for patients Greater than or equal to 45 kg, 3mg is given for those less than 45kg 24-48 hours after chemotherapy
16016866|NCT02761447|Other|Treatment Traditional and Imaginary Motor Program|Amputees patients also conservative protocol will undergo physiotherapy techniques work Imaginary Motor. The first video will include two sequences of a harmonic gear that will allow the patient to examine, with the physiotherapist, the characteristics of the different body segments involved in locomotion and place the member in space. The second video include an analysis in five phases: a) relaxation of Benson, b) phase external imagination where cycles of normal running on a video provided by the physiotherapist, c) phase internal imagination where the patient will identify the problem discussed compared with the normal course presented in the video, d) recreation of images in the first person made an e normalized locomotion) closing his eyes, prompted the patient to mentally recreate sequences normal gait and analyzed and subsequently verbalize differences of these with respect to their own way of getting around.
16016867|NCT02761447|Other|Treatment Traditional and Mirror Therapy|Amputees patients also conservative protocol will undergo physiotherapy techniques mirror therapy work. The protocol will consist of mirror therapy sessions three days a week (25-30 minutes) for a month, where participants will move the intact limb looking in the mirror and imagining the movement of the limb with phantom sensation.
16016868|NCT02761434|Other|Hypertonic Saline (3% NaCl)|0.1 ml of 3% NaCl per kg of body weight per minute
16016869|NCT02761434|Other|Isotonic Saline (0.9% NaCl)|0.1 ml of 0.9% NaCl per kg of body weight per minute
16016870|NCT02761421|Other|observation study|observation study
16016871|NCT02761395|Procedure|Al-hijamah|"Strict sterilization of selected anatomical sites.
~Suction using sterile plastic disposable sucking cups
~Skin scarifications (shartat mihjam): through inducing superficial (0.1 mm in depth), small (2 mm in length), multiple and evenly distributed skin incisions."
16016872|NCT02761395|Drug|Deferasirox|20-40 mg/kg/day orally
16016873|NCT02761382|Other|Mindfulness-based psychological treatment|
16016874|NCT02761382|Other|Non-specific psychological treatment|
16016875|NCT02761369|Device|A multi-channel deep TMS device with an H-coil (Brainsway Ltd)|A 3-week long treatment (15 days). Treatment session consist of 300 rapidly occurring pairs of pulses over the dorsolateral prefrontal cortex (at a frequency of 10 Hz and intensity of 110% of individual's motor threshold), with a 5-seconds interval, for a duration of 1800 seconds in total.
16016876|NCT02761356|Other|Tc99-MAA|To evaluate the fisibility of Tc99-MAA injected intra epatic artery to predict uptake of Yttrium-90 SIRT in patients with liver malignancies
16016877|NCT02761343|Other|MRI scan|Following the clinically indicated cardiac ablation procedure, a post ablation MRI scan will be performed.
16016878|NCT02761330|Drug|Ketamine|Ketamine will be used to induce general anesthesia with or without subsequent ECT. Within a single patient, the dose will remain consistent throughout the study and is estimated to be 2 mg/kg.
16016879|NCT02761330|Procedure|Electroconvulsive Therapy|Dose of the ECT charge will be determined during titration session prior to randomization.
16016880|NCT02761317|Drug|standard preparation (2L PEG-ELS)|Subjects who are randomized into group A will receive standard bowel preparation (2L PEG-ELS) on the same-day of procedure.
16016881|NCT02761317|Drug|low-volume preparation (10 mg bisacodyl plus 2L PEG-ELS)|Subjects who are randomized into group B will receive 10mg bisacodyl at 6 pm on the evening before the colonoscopy and 2L PEG-ELS on the same-day of procedure.
16016882|NCT02761317|Drug|high-volume preparation (4L PEG-ELS)|Subjects who are randomized into group C will receive 2L PEG at 6 pm before the procedure and another 2L PEG-ELS on the same-day of procedure.(4L PEG)
16016883|NCT02761304|Procedure|Ultrasound|
16016884|NCT02761291|Drug|Gemcitabine|Gemcitabine will be administrated 600~1250 mg/m^2 intravenously according to the body surface area at day 1 and day 8 in a 28 day-treatment cycle. The treatment cycle of 28 days will be repeated maximum 6 times. The first dose level of gemcitabine will be started at 800 mg/m^2. If no subject suffered the dose limit toxicity, 1000 mg/m^2 and even 1250 mg/m^2 will be started by order. If subjects suffered the dose limit toxicity in 800 mg/m^2, the 600 mg/m^2 will be started.
16016885|NCT02761291|Drug|Valproic acid|Valproic acid will be administrated orally by the fixed dose 12.5 mg/kg/day according to instructions from day 1 to day 14 in one treatment cycle. The treatment cycle of 28 days will be repeated maximum 6 times.
16016886|NCT02761291|Drug|Valganciclovir|Valganciclovir will be administrated orally by the fixed dose 1350 mg/day (creatinine clearance rate ≥ 60 mL/min) or 900 mg/day (creatinine clearance rate ≥ 40 mL/min and < 60 mL/min) from day 9 to day 15 in one treatment cycle. The treatment cycle of 28 days will be repeated maximum 6 times.
16016889|NCT02761265|Other|None (Asymptomatic group)|Gait and balance testing performed, no treatment in this asymptomatic group
16016890|NCT02761252|Drug|Bilastine 20mg|
16016891|NCT02761252|Drug|Montelukast 10mg|
16016892|NCT02761252|Drug|Placebo Bilastine 20mg|
16016893|NCT02761252|Drug|Placebo Montelukast 10mg|
16016894|NCT02761239|Device|The NIM 3.0 Nerve Monitoring System|Electromyography recordings were accomplished with a pair of needle electrodes inserted through the CP muscle, which were plugged into the third and fourth channels of interface-connector box.The recurrent laryngeal nerve(RLN), vagus nerve, external branch of the superior laryngeal nerve(EBSLN) and pharyngeal plexus were stimulated with a current of 1 mA and a frequency of 4 MHz and the event threshold at 100 microV.
16016895|NCT02761226|Procedure|Platform Matched Design (Group A)|10 patients with missing upper posterior teeth will receive dental implant with platform matched design (the patients will receive implant 4.2mm with same abutment diameter 4.2mm)
16016896|NCT02761226|Procedure|Platform Switching Design (Group B)|10 patients with missing upper posterior teeth will receive dental implant with platform switching design(the patients will receive implant 4.2mm with smaller abutment diameter 3.5 mm
16016897|NCT02761213|Drug|Oral sulfate solution (OSS)|Oral sulfate solution (OSS)
16016898|NCT02761213|Drug|2-L PEG/Asc|Low-dose polyethylene glycol plus ascorbic acid (2-L PEG/Asc) COOLPREP is a proprietary name of 2-L PEG/Asc.
16016899|NCT02761187|Other|No Intervention|
16016900|NCT02761174|Drug|Brimonidine|Patients receive brimonidine to half of their face, whereas the other half receives no treatment and thereby patients are their own control
16016901|NCT02761174|Other|IPL+air-cooling|IPL+air-cooling are applied to the whole face and the control side thereby only receives IPL+air-cooling
16016902|NCT02761161|Drug|Mianserin|mianserin is add-on treatment to treatment as usual. Max dose 30 mg day.
16016903|NCT02761161|Behavioral|Imagery Rehearsal Therapy|IRT is add-on treatment to treatment as usual.
16016904|NCT02761122|Procedure|Human biological samples|"Blood sample
~Skin or mucosal brushing
~Skin or mucosal biopsy"
16016905|NCT02761096|Device|acupuncture|"Acupuncture, electroacupuncture, and intradermal acupuncture will be performed at every session.
~Sterile disposable stainless steel acupuncture needles (0.25 mm × 30 mm) will be used. Acupuncture needles will be inserted bilaterally at the following acupuncture points: LI4, LI11, PC6, ST36, GB39 and LR3, and GV20. If GV20 is close to the surgical site, this acupoint may be excluded.
~An electric stimulator will be connected to the handle of each needle at LI4, LI11, ST36, and LR3 and a current of 5 Hz will be applied.
~After the needles are removed, intradermal acupuncture needles with tape (DB130A; 0.25 mm × 1.5mm) will be inserted at the same acupoints (LI4, LI11, PC6, ST36, GB39, and LR3 bilaterally, and GV20) and left in place until the next session."
16016906|NCT02761096|Other|conventional treatment|The subjects in the control group will only receive conventional treatment. This involves general management after craniotomy in the department of neurosurgery and includes stabilizing vital signs, pain control, prevention and treatment of infections, and other IV fluid or drug therapy required based on the condition of the patient.
16016907|NCT02761083|Device|Novosyn® Quick|Eye surgery
16016908|NCT02761083|Device|Vicryl® Rapid|Eye surgery
16016909|NCT02761070|Drug|Temozolomide|
16016910|NCT02761070|Drug|Bevacizumab|
16016911|NCT02761057|Drug|Cabozantinib S-malate|Given PO
16016912|NCT02761057|Drug|Crizotinib|Given PO
16016913|NCT02761057|Drug|Savolitinib|Given PO
16016914|NCT02761057|Drug|Sunitinib Malate|Given PO
16016915|NCT02761018|Behavioral|Behavioral: Fitness Tracker|will use a fitness tracker but will not be able to see other participant's data
16016916|NCT02761018|Behavioral|Fitness Tracker|will use a fitness tracker and will be able to see other member's daily and weekly results
16016917|NCT02761005|Drug|Eradication of H. pylori|For the eradication of H. pylori, patients diagnosed to be infected with strain with mutation of 23S rRNA, their H. pylori strains are considered to be resistant to clarithromycin. Then, they are treated with vonoprazan 40 mg, metronidazole 500 mg and amoxicillin 1500 mg for 1 week. Patients diagnosed to be infected with strain without mutation of 23S rRNA, their H. pylori strains are considered to be resistant to clarithromycin. Then, they are treated with vonoprazan 40 mg, clarithromycin 400 mg and amoxicillin 1500 mg for 1 week.
16016918|NCT02760992|Drug|IV Baclofen|Baclofen intravenous solution 2 mg/mL manufactured and provided by Allaysis, LLC
16016919|NCT02760992|Drug|Oral Baclofen|10 mg tablet
16016920|NCT02760979|Drug|Denosumab|Denosumab treatment one year after surgery
16016921|NCT02760979|Drug|Placebo|Serum one year after surgery
16016922|NCT02760966|Other|Alcohol 70º|
16016923|NCT02760966|Other|Soap|
16016924|NCT02760953|Procedure|Cryoablation|Using a novel cryoablation unit to perform transurethral cryoablation on the tumor base after transurethral resection
16016925|NCT02760953|Drug|Epirubicin|Epirubicin instillation should be give within 24 hours after initial TUR, this is accord with current guideline.
16016926|NCT02760940|Drug|oral liposomal iron|After screening, anemic patients will be treated during 8 weeks with 28mg of oral liposomal iron per day and then the investigators will report data assessing the tolerability and efficacy of oral liposomal iron treatment in these patients.
16016927|NCT02760927|Device|Endotracheal Tube Fastener|The AnchorFast Guard oral endotracheal tube fastener provides a convenient means to hold an oral endotracheal tube securely in place without the use of adhesive tape. The oral endotracheal tube fastener allows repositioning of the tube in either direction along the track without removal of the device.
16016928|NCT02760901|Drug|Acetazolamide|patients received acetazolamide 250 mg half an hour before cisplatin with saline hydration.for prevention of cisplatin nephrotoxicity
16016929|NCT02760901|Drug|Acetylcysteine|patients received NAC (600 mg every 12 hours) for 4 doses beginning 24 hours before cisplatin with saline hydration.for prevention of cisplatin nephrotoxicity
16016930|NCT02760901|Drug|Mannitol|patients received mannitol 20 % 100 ml half an hour before cisplatin and saline hydration.
16016931|NCT02760901|Drug|saline|saline hydration 2500 ml before cisplatin therapy
16016932|NCT02760901|Drug|Cisplatin|patients with tumours already prescribed cisplatin
16016933|NCT02760888|Drug|Tramadol|Women will receive a oral Tramadol 100mg 1 hour before the procedure
16017026|NCT02760290|Procedure|Extraperitoneal cesarean section|
16016934|NCT02760888|Drug|Diclofenac|Women will receive oral Diclofenac 100mg 1 hour before the procedure
16016935|NCT02760888|Drug|Placebo|Women will receive a Placebo 1 hour before the procedure
16016936|NCT02760875|Behavioral|Early weight bearing|The intervention implies that the selected patients, will be allowed to bear weight on the injured leg form day 1 while wearing the orthosis, in contrast to the control group, who must wait 6 weaks.
16016937|NCT02760862|Drug|hydrocortisone 100mg.|Group (I), received hydrocortisone 100mg, dissolved in 2ml normal saline, intravenously/8 hours for 48 hours
16016938|NCT02760862|Drug|mannitol 20% intravenous fluid|group (II), received mannitol 20% 100ml intravenously which was given over 30 minutes and followed by 100 ml on a 12hour basis. Urinary catheter was inserted for patients in group (II) under complete aseptic conditions by the anesthesia resident before the start of mannitol infusion and removed after its discontinuation, accompanied by the intravenous fluid infusion over 48 hours of 500ml of normal saline or Ringer's solution every 8 hours and the input/output fluid chart for evaluation of fluid balance.
16016939|NCT02760849|Other|Laboratory Biomarker Analysis|Correlative studies
16016940|NCT02760849|Procedure|Oophorectomy|Undergo ISDO
16016941|NCT02760849|Other|Quality-of-Life Assessment|Ancillary studies
16016942|NCT02760849|Procedure|Salpingectomy|Undergo ISDO
16016943|NCT02760849|Procedure|Salpingo-Oophorectomy|Undergo RRSO
16016944|NCT02760823|Drug|Alpha Lipoic Acid (Thioctacid)|600 mg/12 hours, IV (in the vein)
16016945|NCT02760823|Drug|Placebo (for Alpha Lipoic Acid)|Normal saline in syringe simulating Alpha Lipoic Acid 600mg
16016946|NCT02760810|Device|Marketed Contact Lens|Narafilcon A
16016947|NCT02760797|Drug|Emactuzumab|Emactuzumab will be administered IV every 3 weeks (every cycle) during Part I and every 3 or 6 weeks (every cycle or every other cycle) during Part II.
16016948|NCT02760797|Drug|RO7009789|RO7009789 will be administered IV every 3 weeks (every cycle).
16016949|NCT02760784|Behavioral|Early weight bearing|The intervention implies that the selected patients, will be allowed to bear weight on the injured leg form day 1 while wearing the orthosis, in contrast to the control group, who must wait 6 weaks.
16016950|NCT02760771|Other|with BAV|balloon dilation of the aortic valve prior to implantation of the THV
16016951|NCT02760771|Other|without BAV|no balloon dilation of the aortic valve prior to implantation of the THV
16016952|NCT02760758|Drug|CDI-31244|NNI
16016953|NCT02760758|Drug|Placebo|no active ingredients
16016954|NCT02760745|Other|Ancillary tests|Blood culture, complete blood count, crp, urinalysis for all patients. If clinically indicated: Urine culture, chest x ray, csf culture, stool culture, joint fluid culture
16016955|NCT02760732|Device|drug eluting balloon; cutting balloon|Patients eligible for inclusion criteria were randomised to study group for percutaneous transluminal coronary angioplasty with a strategy of cutting balloon pre-dilation first and then drug eluting balloon.
16016956|NCT02760732|Device|drug eluting stent|with a strategy of drug-eluting stent implantation alone for de novo coronary artery lesions.
16016957|NCT02760719|Drug|nebulized 3% hypertonic solution|already described
16016958|NCT02760706|Device|Computed Tomography scan|
16016959|NCT02760680|Device|WatchPAT 200 (TM)|The WatchPAT 200 (TM) is a wrist worn diagnostic device for detecting SDB. Its main part is the measurement of the peripheral arterial tone (PAT) via a plethysmographic based finger-mounted probe. It can measure the level of sympathetic activation of the autonomic nervous system. Pulse rate, oxygen saturation and snoring/body position levels are calculated, too. A software program (zzzPAT (TM)) with a special algorithm analyzes the raw data and creates a sleep report. Therefore the property of the WatchPAT 200 (TM) proclaims that the WatchPAT 200 (TM) can detect sleep events and SDB.
16016960|NCT02760680|Other|Polysomnography|"The PSG is known as the Gold Standard for detecting SDB: experienced sleep physicians and technicians score events (apnea/hypopnea) using current AASM Guidelines."
16016961|NCT02760667|Drug|Cisplatinum|Cisplatin 75mg/m2 every 3 weeks for a maximum of 3 cycles during the induction phase
16016962|NCT02760667|Drug|Docetaxel|Docetaxel 75mg/m2 every 3 weeks for a maximum of 3 cycles during the induction phase
16016963|NCT02760667|Drug|Carboplatin|Carboplatin AUC=5 every 3 weeks for a maximum of 3 cycles during the induction phase (if subject are unable to tolerate cisplatin)
16016964|NCT02760667|Procedure|Transoral Robotic Assisted Surgery|TORS will be performed for the patients who responded to the induction treatment (80% reduction)
16016965|NCT02760654|Device|Proactive Self Management Program for Effects of Cancer Treatment|
16016966|NCT02760641|Other|Egg-based diet (EBD)|Participants will be asked to consume a carbohydrate-restricted diet including whole eggs for 8 weeks. Eggs will be provided.
16016967|NCT02760641|Other|Carbohydrate-based diet (CBD)|Participants will be asked to consume a low fat, carbohydrate-based diet for 8 weeks. Breakfast food items will be provided.
16016968|NCT02760628|Behavioral|The First Twenty (TF20)|TF20 is an online wellness program for firefighters focused on improving cardiovascular risk factors through behavioral changes.
16016969|NCT02760628|Behavioral|Life Simple 7 (LS7)|LS7 is a wellness program designed and implemented by the American Heart Association focused on improving cardiovascular health.
16016970|NCT02760615|Drug|Caffeine|Caffeine tablets
16016971|NCT02760615|Drug|Losartan|Losartan tablets
16016972|NCT02760615|Drug|Omeprazole|Omeprazole capsules
16016973|NCT02760615|Drug|Dextromethorphan|Dextromethorphan capsules
16016974|NCT02760615|Drug|Midazolam|Midazolam syrup
16016975|NCT02760615|Drug|Vedolizumab|Vedolizumab solution for IV infusion
16016976|NCT02760602|Drug|Solanezumab|Administered IV
16016977|NCT02760602|Drug|Placebo|Administered IV
16016978|NCT02760576|Drug|BAY 987521|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
16016979|NCT02760563|Drug|BAY 987517|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application (Formulation number V26-160)
16016980|NCT02760550|Other|No intervention|Participants of all three groups completed a questionnaire.
16017027|NCT02760290|Procedure|Intraperitoneal cesarean section|
16017028|NCT02760277|Drug|Vamorolone 0.25 mg/day/day|Oral administration of 0.25 mg/kg/day daily for 24 weeks.
16017517|NCT02756832|Drug|Alogliptin Benzoate|Alogliptin benzoate tablets
16016981|NCT02760537|Behavioral|Lay Health Worker Intervention|Lay Health Worker Phone Intervention The second phase addressed phone intervention training, where LHWs who had completed the first phase and were willing to participate in the second phase learned the process for calling participants to remind them to complete a series of HBV vaccinations. The LHWs assigned to the intervention group conducted phone interventions by reminding participants about completing a series of vaccinations at Months 1, 2, and 6, and also provided accompanying resources and support.
16016982|NCT02760537|Behavioral|Placebo (a list of resources)|Those in the control group received a list of resources along with their results by mail that offered free vaccinations, such as local health departments.
16016983|NCT02760524|Behavioral|NET Intervention|Neuro-emotional Technique
16016984|NCT02760511|Dietary Supplement|Anthocyanin|Capsules with different anthocyanin content
16016985|NCT02760511|Dietary Supplement|Placebo|Placebo capsules
16016986|NCT02760498|Drug|cemiplimab|
16016987|NCT02760485|Drug|itacitinib|Phase 1 will evaluate itacitinib at the protocol-specified starting dose, with a possible increase or decrease depending on tolerability. Phase 2 will evaluate the recommended dose determined in Phase 1.
16016988|NCT02760485|Drug|ibrutinib|
16016989|NCT02760472|Drug|SMOFlipid|Parenteral fatty acid supplementation to preterm infants in preventing retinopathy of prematurity
16016990|NCT02760472|Drug|Clinoleic|Parenteral fatty acid supplementation to preterm infants in preventing retinopathy of prematurity
16016991|NCT02760459|Drug|Dexamethasone|
16016992|NCT02760459|Drug|Normal saline solution|
16016993|NCT02760446|Behavioral|CAM-ICU.fr|Neuropsychological testing
16016994|NCT02760433|Drug|Olokizumab|160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial, containing a target fill volume of 1.1 mL (for withdrawal of not less than 0.8 mL) or a target fill volume of 0.5 mL (for withdrawal of not less than 0.4 mL)
16016995|NCT02760433|Drug|Placebo|sodium chloride 0.9% solution provided as either a 10 mL vial or ampoule, depending on market availability. Each placebo will be packed into a cardboard carton to contain 1 vial or ampoule
16016996|NCT02760420|Drug|Amoxicillin|Oral amoxicillin dispersible tablets (DT), 250 mg tablets, given according to age band, two times daily
16016997|NCT02760420|Drug|Placebo|Oral placebo dispersible tablets (DT), 250 mg tablets, given according to age band, two times daily
16016998|NCT02760407|Drug|Olokizumab 64mg q4w|160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial, containing a target fill volume of 1.1 mL (for withdrawal of not less than 0.8 mL) or a target fill volume of 0.5 mL (for withdrawal of not less than 0.4 mL)
16016999|NCT02760407|Drug|Olokizumab 64mg q2w|160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial
16017000|NCT02760407|Drug|Adalimumab 40mg q2w|0.4 or 0.8 mL prefilled, single-dose syringe
16017001|NCT02760407|Drug|Placebo q2w|sodium chloride 0.9% solution supplied in either a 10 mL vial or ampoule, depending on market availability. Each placebo will be packed into a cardboard carton to contain 1 vial or ampoule
16017002|NCT02760394|Device|HBOT|40 daily sessions, 90 minutes of 100% oxygen at pressure of 2 ATA each, five days a week for 8 weeks.
16017003|NCT02760381|Device|NBI + Acetic Acid (AA)|Patients belonging to the Routine colonoscopy Cohort will receive NBI + Acetic Acid (AA) chromoendoscopy for optical predictions of colonic polyps.
16017004|NCT02760368|Drug|Olokizumab|160 mg/mL sterile solution for SC injection in a 2 mL clear Type I glass vial
16017005|NCT02760368|Drug|Placebo|sodium chloride 0.9% solution supplied in polypropylene plastic ampoules of 10 mL cartons to contain 10 ampoules
16017006|NCT02760355|Drug|Ledipasvir 90 mg/Sofosbuvir 400 mg|Oral administration on one fixed dose combination tablet for 12 weeks
16017007|NCT02760355|Drug|Ribavirin|Oral administration of body weight-dose adjusted, 200 mg-tablets of ribavirin (1,000 mg in two administration in patients <75 Kg of body weight, or 1,200 mg in two administrations for those >75 Kg) for 12 weeks.
16017008|NCT02760342|Drug|peficitinib|Oral
16017009|NCT02760342|Drug|Metformin|Oral
16017010|NCT02760329|Procedure|Blood draw|Biomarkers analyses
16017011|NCT02760329|Procedure|Urine|Biomarker analyses
16017012|NCT02760329|Procedure|Lung function measurements|FEV1, FVC, PEF, FEF25-75%, IC, calculated FEV1/FVC ratio and calculated FEV1 % predicted
16017013|NCT02760329|Procedure|Fractional Exhaled Nitric Oxide (FENO)|Measures level of exhaled nitric oxide.
16017014|NCT02760316|Drug|AZD9567 10 mg|Oral suspension Multiple doses 5 days of treatment Once daily
16017015|NCT02760316|Drug|AZD9567 20 mg|Oral suspension Multiple doses 5 days of treatment Once daily
16017016|NCT02760316|Drug|AZD9567 40 mg|Oral suspension Multiple doses 5 days of treatment Once daily
16017017|NCT02760316|Drug|AZD9567 80 mg|Oral suspension Multiple doses 5 days of treatment Once daily
16017018|NCT02760316|Drug|Prednisolone 20 mg|Oral Multiple doses 5 days of treatment Once daily
16017019|NCT02760316|Drug|AZD9567 125 mg|Oral Multiple doses 5 days of treatment Once daily
16017020|NCT02760316|Drug|AZD9567 155 mg|Oral Multiple doses 5 days of treatment Once daily
16017021|NCT02760316|Drug|Prednisolone 5 mg|Oral Multiple doses 5 days of treatment Once daily
16017022|NCT02760316|Drug|Prednisolone 40 mg|Oral Multiple doses 5 days of treatment Once daily
16017023|NCT02760303|Behavioral|Cognitive Behavioral Therapy|Participants will attend group therapy sessions, once a week for 9 weeks. The focus of these sessions will be the thought-emotion-behavior linkages as outlined by cognitive-behavioral theory. Activities will illustrate how thoughts affect emotions and behaviors, the application of these activities to current stressors, and strategies to apply these new skills to future stressors.
16017024|NCT02760303|Behavioral|Mindfulness Based Stress Reduction|Participants will attend group therapy sessions, once a week for 9 weeks. The focus of these sessions will be understanding how to gain control over one's thoughts and feelings using relaxation, meditation, and other mindfulness-based techniques. Activities will focus on the instruction and practice of mindfulness techniques, such as meditation and yoga, and the application of these practices to everyday activities.
16017025|NCT02760303|Behavioral|Diabetes Support and Education|Participants will attend group therapy sessions, once a week for 9 weeks. Participants will receive diabetes education via a support group format. The focus of these sessions will be peer group social support and non-adherence diabetes education topics (e.g., emergency preparedness, smoking and diabetes).
16017029|NCT02760277|Drug|Vamorolone 0.75 mg/day/day|Oral administration of 0.75 mg/kg/day daily for 24 weeks.
16017030|NCT02760277|Drug|Vamorolone 2.0 mg/day/day|Oral administration of 2.0 mg/kg/day daily for 24 weeks.
16017031|NCT02760277|Drug|Vamorolone 6.0 mg/day/day|Oral administration of 6.0 mg/kg/day daily for 24 weeks.
16017032|NCT02760264|Drug|Vamorolone 0.25 mg/kg/day|Oral administration of 0.25 mg/kg/day daily for 14 days.
16017033|NCT02760264|Drug|Vamorolone 0.75 mg/kg/day|Oral administration of 0.75 mg/kg/day daily for 14 days.
16017034|NCT02760264|Drug|Vamorolone 2.0 mg/kg/day|Oral administration of 2.0 mg/kg/day daily for 14 days.
16017035|NCT02760264|Drug|Vamorolone 6.0 mg/kg/day|Oral administration of 6 mg/kg/day daily for 14 days.
16017036|NCT02760251|Drug|romiplostim|
16017037|NCT02760238|Other|Observational|
16017038|NCT02760225|Drug|89Zr-Pembrolizumab|In part A of the imaging trial, a dose finding imaging study will be performed to assess the optimal tracer protein dose of 89Zr-pembrolizumab and the optimal interval between tracer injection and scanning. Approximately 3 cohorts of about 2-3 patients each will undergo 89Zr-pembrolizumab-PET imaging before start of treatment with pembrolizumab. In part B, 12 eligible patients will undergo 89Zr-pembrolizumab-PET imaging at baseline, with the optimal tracer protein dose and scanning schedule as determined in part A.
16017039|NCT02760225|Device|89Zr-Pembrolizumab PET|In part A of the imaging trial, a dose finding imaging study will be performed to assess the optimal tracer protein dose of 89Zr-pembrolizumab and the optimal interval between tracer injection and scanning. Approximately 3 cohorts of about 2-3 patients each will undergo 89Zr-pembrolizumab-PET imaging before start of treatment with pembrolizumab. In part B, 12 eligible patients will undergo 89Zr-pembrolizumab-PET imaging at baseline, with the optimal tracer protein dose and scanning schedule as determined in part A.
16017040|NCT02760212|Device|Radial Shockwave Therapy|5 treatments in total scheduled weekly; RSWT to the painful areas will be undertaken with 500 shocks (1.5 bar, 15 Hz), then 1000 shocks (2 bar, 8 Hz), and finally 500 shocks (1.5 bar, 15 Hz) to the most painful spot within each of the 3 most painful regions as described by the participant.
16017041|NCT02760212|Other|Placebo Comparator: Group 2 - Placebo Group|5 treatments in total scheduled weekly; placebo to the painful areas will be undertaken with 2000 shocks to the most painful spot within each of the 3 most painful regions as described by the participant.
16017042|NCT02760199|Drug|89Zr-AMG211|Injection of 89Zr-AMG211 for imaging.
16017043|NCT02760199|Device|89-ZrAMG211 PET|89Zr-AMG211 PET scan(s).
16017044|NCT02760186|Procedure|Altitude Exposure|Altitude Exposure
16017045|NCT02760173|Other|perception of vertical after static roll-tilt over 5min|subjects will indicate perceived direction of vertical after 5min of static whole-body roll-tilt.
16017046|NCT02760160|Other|Reconstituted grape powder|To prevent UV-induced skin cancers. Each subject's will have one arm exposed to 6 separate doses of UV (J/m2) [114, 217, 343, 500, 619, 848].
16017047|NCT02760147|Device|Pressure Support Over Support|Pressure Support Level upward by 50%, 2 hours
16017048|NCT02760147|Device|Pressure Support Under Support|Pressure Support Level downward by 50%, 2 hours
16017049|NCT02760147|Device|PEEP Over Level|PEEP Level upward by 50%, 2 hours
16017050|NCT02760147|Device|PEEP Under Level|PEEP Level downward by 50%, 2 hours
16017051|NCT02760134|Procedure|Super-Mini Percutaneous Nephrolithotomy|Patients undergo Super-Mini Percutaneous Nephrolithotomy
16017052|NCT02760121|Drug|Acetazolamide|
16017053|NCT02760121|Drug|Methazolamide|
16017054|NCT02760121|Drug|Placebo|
16017055|NCT02760095|Drug|3 mg zinc sulfate supplement|
16017056|NCT02760095|Drug|0.5 mg of 13C10-retinyl-acetate|
16017057|NCT02760082|Other|Qualitative evaluation|
16017058|NCT02760069|Drug|Inhaled isopropyl alcohol|Patients will inhale from isopropyl alcohol pads as needed for nausea up to q30 minutes.
16017059|NCT02760069|Drug|Oral ondansetron|Patients will drink elixir containing 4 mg ondansetron in 5 ml of solution. National Drug Code (NDC) 0054-0064-47.
16017060|NCT02760069|Drug|Inhaled normal saline|Patients will inhale from normal saline pads as needed for nausea up to q30 minutes.
16017061|NCT02760069|Drug|Oral placebo|Subjects will drink solution comprised of 0.25 ml of Oral Sweet Sugar Free NDC 0574-0302-16 with 4.75 ml of sterile water for dilution NDC 0264-2101-00
16017062|NCT02760056|Drug|Liothyronine sodium|Subjects will be divided into 4 groups of progressively escalating doses. Each group will have 6 subjects 4 will receive the active treatment and 2 will receive the placebo. The first group will receive 25 mcg twice daily for one week. The second group will receive 37.5 mcg twice daily for one week. The third group will receive 50 mcg twice daily for one week. The forth group will receive 75 mcg twice daily for one week.
16017063|NCT02760056|Drug|Placebo|Patient will receive a matching placebo to take twice daily for one week.
16017064|NCT02760043|Drug|Dexamethasone|8mg (2mL) of Dexamethasone added to standard LIA mixture
16017065|NCT02760043|Other|0.9% NaCl Placebo|2mL of 0.9% NaCl placebo (saline) added to standard LIA mixture
16017066|NCT02760043|Drug|LIA Combination Mixture|150mL 2% Ropivacaine, 30mg Ketorolac and 0.6mg of Epinephrine
16017067|NCT02760030|Drug|Fulvestrant|Given IM
16017068|NCT02760030|Other|Laboratory Biomarker Analysis|Correlative studies
16017069|NCT02760030|Drug|Palbociclib|Given PO
16017070|NCT02760030|Other|Questionnaire Administration|Correlative studies
16017071|NCT02760030|Drug|Aromatase Inhibitors|Given PO
16017072|NCT02760017|Drug|B. forficata|
16017073|NCT02760017|Drug|Placebo|
16017074|NCT02760004|Behavioral|PRogram In Support of Moms (PRISM)|"PRogram In Support of Moms Toolkit with Stepped Care Algorithms
~Support clinic specific implementation using the Addressing Problems Through Organizational Change (APTOC) platform
~Customization of depression screening for each practice
~Proactively engage and track all women who screen +ve on the Edinburgh Postnatal Depression Scale(EPDS)
~Employ psychoeducation and Motivational Interviewing to engage patients with depression
~medical assistant champion and psychiatrist contact bi-weekly to review cases
~Stepped care treatment to depression screening/assessment"
16017105|NCT02759783|Other|Standard of Care|Choice of standard of care treatment at the discretion of the local oncologist. This may include: Chemotherapy, Endocrine therapy, surgery, palliative radiotherapy
16017106|NCT02759770|Other|no intervention|This is a clinical observational study, no intervention was included.
16017075|NCT02760004|Behavioral|Enhanced Usual Care group (Access to MCPAP for Moms)|"30-60 minute presentation on perinatal depression
~Access to telephonic psychiatric consultation with MCPAP for Moms perinatal psychiatrist for Ob/Gyns
~Access to Ob/Gyn provider assessment and treatment recommendations via one-time face-face MCPAP for Moms psychiatrist patient evaluation
~Access to assessment and treatment protocols in Provider Toolkit
~Resource provision/referrals"
16017076|NCT02759991|Drug|Hecolin|0.6ml Hecolin vaccine im. on day 0, 1 month and 6 months.
16017077|NCT02759991|Drug|Hepa-B|1ml Hepa-B vaccine im. on day 0, 1 month and 6 months.
16017078|NCT02759978|Other|diagnostic workup|Our primary objective is to test whether the proportion of patients diagnosed correctly with the use of 18F-FDG-PET/CT, MD-CTA, and 18F-FDG-PET/MD-CTA added to the gold standard in current clinical practice, the modified Duke criteria by Li et al. 2000, is significantly higher as compared with the modified Duke criteria on itself. The gold standard is clinical judgement after clinical follow-up by a multidisciplinary team with medical specialists.
16017079|NCT02759939|Other|Video + Prompt Card|"A brief video (available in English and Spanish) intended to be viewed by patients immediately before the health care visit. The video aims to enhance patients' motivation, skills, and self-efficacy to ask their health care providers three specific questions: (1) What are my options? (2) What are the pros and cons of those options? and (3) How likely are those pros and cons to happen to me?
~A prompt card (available in English and Spanish) intended to be provided to patients when they view the video and kept. The card aims to remind patients of the three questions presented in the video."
16017080|NCT02759939|Other|Decision Aids + Training|"Seven one-page decision aids on contraceptive methods (available in English and Spanish) intended to be used by health care providers with patients during the health care visit.
~A five-minute training video and accompanying written guidance (available in English) intended to be reviewed by health care providers before implementing the decision aids (and as frequently as desired thereafter). The training aims to enhance providers' motivation, skills, and self-efficacy to use the decision aids to facilitate shared decision-making in the health care visit."
16017081|NCT02759926|Drug|Denatonium benzoate|
16017082|NCT02759926|Drug|Quinine hydrochloride|
16017083|NCT02759926|Drug|Tap water|
16017084|NCT02759913|Procedure|Lumbar puncture|Collection of biofluids to determine the accuracy, sensitivity and specificity of a diagnostic test developed by Iron Horse Diagnostics
16017085|NCT02759900|Device|Non-thermal, atmospheric plasma to treat skin lesions and acne|Non-thermal, atmospheric plasma treatment of affected area or lesions using a nanosecond dielectric barrier discharge plasma device
16017086|NCT02759900|Device|Indirect non-thermal, atmospheric plasma to treat hair loss and acne|A compound of non-thermal, atmospheric plasma and medium is delivered to or generated at the target area. Plasma is generated using either microsecond dielectric barrier discharge plasma device or PiezoBrush (a helium jet plasma). The medium is an aqueous alcohol solution
16017087|NCT02759887|Procedure|biospecimen collection|Blood: ApoE genotyping, comprehensive metabolic panel, RNA sequencing. Urine: beta-hCG (human corionic gonadotropin) testing.
16017088|NCT02759887|Other|cognitive assessments|Dementia Questionnaire for People with Learning Disabilities; Mini-Mental State Examination; Severe Impairment Battery; Vineland Adaptive Behavior Scale; Arizona Memory Assessment for Intellectual Disability; Kaufman Brief Intelligence Test; Nepsy Mazes; and, Timed Up and Go.
16017089|NCT02759887|Other|caregiver questionnaire|
16017090|NCT02759887|Procedure|Florbetapir F18 imaging|Used in small doses to image brain amyloid-beta deposits in human beings. Radioactivity necessary to create the positron emission tomography (PET) images. Radiation exposure is slightly more than a person would receive from a routine clinical head computed tomography scan.
16017091|NCT02759887|Procedure|MRI|Magnetic resonance imaging of the head and brain.
16017092|NCT02759887|Procedure|Fludeoxyglucose F18 (FDG)|Injected intravenously during a PET scan and is a marker for the tissue uptake of glucose; a radiopharmaceutical compound.
16017093|NCT02759887|Procedure|Tau Pet|Administered during a PET, in small amounts, necessary to create the scan images. Radioactive. The total amount of radiation is about the same that a patient receives from a routine abdominal/pelvis computerized tomography.
16017094|NCT02759887|Procedure|Actigraphy|A non-invasive method of monitoring human rest and activity cycles. A small actigraph unit is worn to measure gross motor activity. The unit is usually worn on the wrist.
16017095|NCT02759874|Device|specialized breathalyzer w face recognition technology|
16017096|NCT02759861|Drug|harvoni|8 or 12 weeks of harvoni therapy with monthly nursing visiting to monitor alcohol and adherence of harvoni therapy
16017097|NCT02759835|Drug|osimertinib|Single daily dose of osimertinib until progression. The starting dose of osimertinib will be 80 mg per day for patients without leptomeningeal disease and 160 mg per day for those with leptomeningeal disease at baseline.
16017098|NCT02759835|Other|LAT|local ablative therapy. Subjects may undergo 1 of 3 local ablative procedures after initial progression on osimertinib: surgery, radiotherapy, radiofrequency ablation
16017099|NCT02759822|Procedure|Haploidentical Stem Cell Transplantation|Haploidentical Stem Cell Transplantation from a related donor (partially matched sibling, father, mother, son or daughter).
16017100|NCT02759809|Other|Pasteurized donor human breastmilk|
16017101|NCT02759809|Other|Preterm formula|
16017102|NCT02759796|Procedure|Tailoring the flap according to clinical assessment|After microvascular anastomosis is performed, the investigators clinically assess flap vascularization and the well vascularized tissue is marked by means of a dermographic pencil. Then the investigators administer 0,2mg/kg of ICG intravenously. The vascularization of the flap is also checked by means of the Photo Dynamic Eye (Pulsion Medical System) but finally the decision of discarding the poorly vascularized areas of the flap is made by clinical assessment.
16017103|NCT02759796|Procedure|Tailoring the flap according to ICG Angiography assessment|After microvascular anastomosis is performed, the investigators administer 0,2mg/kg of ICG intravenously. Then the investigators check the vascularization of the flap by means of the Photo Dynamic Eye (Pulsion Medical System) and the poorly vascularized areas of the flap are discarded guided by ICG perfusion test.
16017104|NCT02759783|Radiation|SBRT|Patients will receive a dose and fractionation regimen dependent on the metastatic site and proximity to normal tissues. If allocated to SBRT, SBRT will precede SOC. All patients should commence SOC therapy within 4 weeks of completing SBRT treatment.
16017148|NCT02759354|Other|Blood Sample|Blood sample at approx. 4 years of age
16017107|NCT02759757|Other|Kinesio Taping|This is a tape that can be placed in different parts of the body using different shapes and tensions. In theory, this tape can change muscle activity.
16017108|NCT02759757|Other|Placebo|A micropore tape will be used as placebo
16017109|NCT02759744|Device|ultrasound image-guided ablation device|ultrasound image-guided focal ablation - may be either laser ablation or cryotherapy
16017110|NCT02759731|Drug|Baricitinib|Cycle=28 days: Baricitinib: 1mg-4mg PO QD
16017111|NCT02759718|Biological|Chromogranin A|The plasma level of chromogranin A (CgA) was measured in enrolled patients who was diagnosed as PNET in preoperative condition.After surgical resection, the CgA level was only measured in the the patient with PNET. In the PNET group, the CgA level was regularly checked in a 3, 6, 12, and 24 months after surgical resection.
16017112|NCT02759692|Device|TEST Contact Lens|
16017113|NCT02759692|Device|CONTROL Contact Lens|
16017114|NCT02759679|Other|Human breath samples|
16017115|NCT02759666|Drug|SHR3162|SHR3162 capsule(s) is administered orally QD.
16017116|NCT02759640|Drug|HS-10241|HS-10241 is administered orally starting at 100 mg/day.
16017117|NCT02759627|Other|Robotic-Assisted Gait Training|"There were three intervention arms in this study,
~Robotic-Assisted Gait Training,
~Conventional Training,
~Combined Training."
16017118|NCT02759614|Drug|Bevacizumab|Bevacizumab15mg/kg by intravenous drip infusion on day 1 of a 21-day (within 3 days) cycle and Erlotinib orally once daily at 150mg/day
16017119|NCT02759614|Drug|Erlotinib|Erlotinib 150mg, orally once a day
16017120|NCT02759601|Drug|Tefinostat|Tefinostat is a novel type of HDACi used in cancer targeted specifically to cell of monocyte - macrophase lineage
16017121|NCT02759588|Biological|GL-ONC1 alone, or in combination with chemotherapy with or without bevacizumab|GL-ONC1 is a genetically-engineered oncolytic vaccinia virus, which is administered via intraperitoneal infusion as multiple doses.
16017122|NCT02759575|Drug|Pembrolizumab|200mg every 3 weeks starting 3 weeks prior to chemoradiotherapy. Maximum of 4 doses
16017123|NCT02759575|Radiation|Radiation Therapy|70 Gy in 35 fractions over 7 weeks
16017124|NCT02759575|Drug|Cisplatin|100 mg/m2 every 3 weeks starting on day 1 of chemoradiotherapy. Maximum of 3 doses.
16017125|NCT02759562|Drug|Andecaliximab|Administered via subcutaneous injection
16017126|NCT02759562|Drug|Placebo|Administered via subcutaneous injection
16017127|NCT02759549|Behavioral|eSMART-MH|eSMART-MH (Electronic Self-Management Resource Training for Mental Health) is a software, which is set in a 3-D virtual primary care office environment in which a subject interacts with avatar virtual healthcare staff (medical receptionist, medical assistant, providers, and a virtual healthcare coach). The avatars are programmed to behave like humans. The subject moves through the 3-D virtual primary care office and encounters virtual healthcare staff and providers. The subject practices discussing depressive symptoms with avatar healthcare providers and practices self-management skills related to symptoms of depression.The subject also interacts with the health care coach. The health care coach provides the subject with real-time strategies to enhance communication with healthcare providers during their virtual office visit. eSMART-MH will be used once a week throughout the duration of radiation treatment.
16017128|NCT02759549|Other|Mobile Mood Tracking (Mood 24/7)|Public social media data posted by participants will be accessed and downloaded to a computer program. Permission for the study team to access this data is optional.
16017129|NCT02759549|Behavioral|Theater Testing Workshop|The theater testing workshop consists of one to two one-on-one sessions with study staff during which participants will review a computer program for its content and usability, as well as discuss areas for improvement. Participants will also be asked to complete questionnaires and a attend a brief interview regarding any suggested improvements for the computer program.
16017130|NCT02759536|Radiation|Boronophenylalanine and IHNI-based BNCT|Patients will be infused Boronophenylalanine (BPA)-fructose solution intravenously at a dose of 350mg/kg over 90 minutes. After BPA infusion, patients will receive neutron irradiation in IHNI for a certain period of time based on his boron bio-distribution curve and BPA concentration in the blood.
16017131|NCT02759510|Drug|Norepinephrine|Hypotension (systolic BP <80% of baseline) will be treated with intravenous boluses of norepinephrine 2 μg.
16017132|NCT02759510|Drug|Phenylephrine|Hypotension (systolic BP <80% of baseline) will be treated with intravenous boluses of phenylephrine 40 μg.
16017133|NCT02759497|Other|serum amyloid A level|serum amyloid A level (SAA)
16017134|NCT02759484|Behavioral|Home Based Enhanced Education|The Home Based Enhanced Education arm consists of a diabetes self-management curriculum delivered by Community Health Workers in the participant's home. Participants receive 24 visits: 12 biweekly visits in the first 6 months, followed by 12 monthly visits in months 6 through 18 of the study. The self-management program is derived from two pragmatic evidence-based frameworks for behavioral change.
16017135|NCT02759484|Behavioral|Clinic Based Enhanced Education|The Clinic Based Enhanced Education arm consists of two two-hour-long sessions of group diabetes self-management education, delivered by a Certified Diabetes Educator. Participants in this arm will also receive 24 newsletters with diabetes self-management education.
16017136|NCT02759471|Device|comfilcon A sphere lens (control)|contact lens
16017137|NCT02759471|Device|comfilcon A asphere lens (test)|contact lens
16017140|NCT02759445|Other|routine treatment|No intervention, only observation and describing
16017141|NCT02759432|Other|High-intensity interval exercise training|
16017142|NCT02759419|Drug|Adempas (Riociguat, BAY63-2521)|0.5 to 2.5 mg in 0.5 mg increments (according to individual adapted optimal dose determined in originating study) administered three times daily (tid)
16017143|NCT02759406|Device|coronary stent|
16017144|NCT02759393|Drug|Dexlansoprazole|receiving 8-week PPI
16017145|NCT02759393|Drug|Lansoprazole|receiving 8-week PPI
16017146|NCT02759380|Other|Phytoestrogen-rich foods|The patients will be given a package containing food with a high amount of phytoestrogens (≥100 mg isoflavonoids and ≥100 mg lignans) that are to be consumed daily. The food-package contains 30 grams of flaxseed, 25 grams of roasted soybeans and 50 grams of frozen green edamame beans to be consumed daily.
16017147|NCT02759367|Other|High potassium diet|An increase in consumption of high potassium fruits and vegetables
16087675|NCT02253784|Drug|Bupivacaine|
16017149|NCT02759341|Other|Manual for the Assessment and Documentation of Psychopathology (AMDP 8)|
16017150|NCT02759341|Other|Million Clinical Multiaxial Inventory 3 (MCMI-III)|
16017151|NCT02759341|Other|State-Trait Anxiety Inventory form Y (STAI-Y)|
16017152|NCT02759341|Other|SF-36 Health-Related Quality of Life|
16017153|NCT02759341|Other|Blood oxygenation level dependent- functional Magnetic Resonance Imaging (BOLD-fMRI)|
16017154|NCT02759328|Behavioral|Xbox Kinect™ training|Xbox Kinect™ (Xbox 360, Microsoft, United States) game console which is one of the commercial interactive game consoles was used. It was comprised of 3 components; Kinect™ sensor, Xbox 360™ game console and 42 inch Liquid crystal display (LCD) television.
16017155|NCT02759328|Behavioral|Conventional rehabilitation|The conventional rehabilitation program consisted of passive and active range of motion exercises, therapeutic stretching, muscle strengthening, neurophysiologic exercises, sitting, standing, balance and gait exercises, occupational therapy and activities of daily living training such as eating, grooming, dressing, toileting and transfer.
16017156|NCT02759315|Drug|Uprifosbuvir 450 mg|450 mg administered as 3 x 150 mg oral tablets
16017157|NCT02759315|Drug|Ruzasvir 60 mg|60 mg administered as 6 x 10 mg oral capsules
16017158|NCT02759263|Behavioral|Cogmed Working Memory Training|Cogmed Working Memory Program will be used as a computerized home-based intervention. Families will receive a link for downloading a web-based software program. The program will be installed on a computer at a family's home by a research assistant. Parents and adolescents will be actively involved, and during the installation session, adolescents will complete several practice trials. The 25 sessions will be completed individually by the adolescent with parental supervision. For the first 5 sessions, the participant trains on the same set of games; on the 6th session and every 5th session thereafter, a new task is introduced and replaces one of the initial tasks. At the end of each session, the adolescent can play an age-appropriate computerized game as a reward. After each session, results are uploaded by parents to a secure website, to keep track of the participant's progress. Families will be contacted weekly to check program function and discuss concerns.
16017159|NCT02759250|Drug|ARGX-110|
16017160|NCT02759237|Device|CoreValve System Family|"Bioprosthesis: Transcatheter Aortic Valve Implant (TAV - Heart Valve) -Different Models/Sizes of CoreValve/CoreValve Evolut R.
~Delivery Catheter System: ACCUTRAK & EnVeo R - Used to facilitate the placement of the bioprosthesis within the annulus.
~Loading System: Compression Loading System & EnVeo R Loading System - Used to load the TAV onto the delivery system"
16017161|NCT02759224|Drug|BRI-1501|
16017162|NCT02759224|Drug|Lafutidine|
16017163|NCT02759224|Drug|Irsogladine maleate|
16017164|NCT02759211|Other|Backwards Walking|The Backwards Walking Group will perform backwards walking for the entire treatment intervention.
16017165|NCT02759211|Other|Forwards Walking|The Forwards Walking Group will perform forwards walking for the entire treatment intervention.
16017166|NCT02759198|Drug|YH23537|Drug: YH23537 750mg Drug: YH23537 1500mg Drug: YH23537 3000mg
16017167|NCT02759198|Drug|Celecoxib|Drug: Celecoxib 200mg
16017168|NCT02759198|Drug|YH23537 placebo|Drug: YH23537 750mg placebo Drug: YH23537 1500mg placebo Drug: YH23537 3000mg placebo
16017169|NCT02759185|Drug|High THC cannabis|Three weeks of smoking cannabis containing more THC than CBD with amount smoked limited to no more than 1.8 g per day.
16017170|NCT02759185|Drug|High CBD cannabis|Three weeks of smoking cannabis containing more CBD than THC with amount smoked limited to no more than 1.8 g per day.
16017171|NCT02759185|Drug|THC/CBD cannabis|Three weeks of smoking cannabis containing equal amounts of THC and CBD with smoking limited to no more than 1.8 g per day.
16017172|NCT02759185|Drug|Placebo cannabis|Three weeks of smoking cannabis with low levels of THC and CBD with smoking limited to no more than 1.8 per day.
16017173|NCT02759172|Behavioral|Safety Planning Intervention|Brown and Stanley's Safety Planning Intervention (SPI) is a brief, adjunctive intervention designed to reduce subsequent suicidal behavior in high-risk populations. The core element of SPI is the collaborative development of the Safety Plan, which is a prioritized written list of coping strategies and supports that individuals can use during or preceding suicidal crises. In this study, safety planning will occur during pretrial jail detention, with telephone follow-up in the community to conduct risk assessment, review the Safety Plan, problem-solve obstacles to treatment, and assist with linkage to services.
16017174|NCT02759159|Procedure|true acupuncture|"acupuncture at the four-gateacupoints, three times per week and last for 6 months"
16017175|NCT02759159|Procedure|sham acupuncture|"acupuncture at the places 1cm from the true four-gate acupoints,three times per week and last for 6 months"
16017176|NCT02759146|Other|Reflexology|Reflexology is a specialized foot therapy that applies a firm walking motion pressure to the feet. It is based on the premise that the foot has reflexes that mirror the rest of the body. It has been shown to reduce symptoms.
16017177|NCT02759146|Other|Meditative Practices|Meditative Practices include elements of meditation, gentle yoga and breathing exercises. These practices focus purposeful attention to the present moment and have been shown to enhance one's ability to adapt to serious health concerns
16017178|NCT02759133|Device|Metal wire|Localization technique for breast surgery using metal wire
16017179|NCT02759133|Device|Radioactive Iodine Seed|Localization technique for breast surgery using Radioactive Iodine Seed
16017180|NCT02759120|Drug|Antimicrobial therapy: Co-trimoxazole or Doxycycline|160mg trimethoprim/800mg sulfamethoxazole (double strength co-trimoxazole) twice daily plus folic acid 5 mg daily OR doxycycline 100mg once daily if weight < 50 kilograms or 100mg twice daily if weight > 50 kilograms for up to 36 months
16017181|NCT02759120|Other|No Intervention: Standard of Care|Standard of care
16017182|NCT02759107|Drug|LY3298176|Administered SC
16017183|NCT02759107|Drug|Placebo|Administered SC
16017184|NCT02759107|Drug|Dulaglutide|Administered SC
16017185|NCT02759094|Device|Treatment with RefluxStop|A standard laparoscopic approach will be used to reposition the lower oesophageal sphincter (LES) to its intra-abdominal position. The RefluxStop device will be then positioned and fixed in the gastric funds to ensure intra-abdominal positioning of the GEJ (Gastro-oesophageal Junction) at all time. After confirming proper placement, the laparoscopic implant procedure will be completed and access points will be closed.
16017186|NCT02759081|Device|cap-assisted water exchange|a transparent cap was mounted to the tip of colonoscopy when water exchange was performed.
16087912|NCT02252042|Drug|docetaxel|
16017187|NCT02759081|Procedure|water exchange|water was infused and suctioned at the same time during insertion of colonoscope
16017188|NCT02759068|Behavioral|sounds and odors|presentation of sounds and odors
16017189|NCT02759055|Other|Clinical Decision Support|an EHR-linked, Web-based clinical decision support (CDS) system that identifies patients with prediabetes and provides patients and their primary care providers personalized, evidence-based CDS and follow up to reduce risk of heart attacks or stroke
16017190|NCT02759042|Drug|PRO 140|PRO 140 is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
16017191|NCT02759029|Drug|eradication of Helicobacter pylori|"clarithromycin-based triple therapy Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Clarithromycin 500mg, PO, BID, 1wk
~concomitant therapy group Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Clarithromycin 500mg, PO, BID, 1wk Metronidazole 500mg, PO, BID, 1wk
~bismuth based quadraple therapy Pantoloc 40mg, PO, BID, 1wk Bismuth, 300mg, PO, QID, 1wk Tetracycline, 500mg, PO, QID, 1wk Metronidazole, 500mg, PO, TID, 1wk
~levofloxacine based triple therapy Pantoloc 40mg, PO, BID, 1wk Amoxacillin 1g, PO, BID, 1wk Levofloxacin 500mg, PO, QD, 1wk"
16017192|NCT02759016|Drug|BI 836826|
16017193|NCT02759016|Drug|Ibrutinib|Standard of Care
16017194|NCT02759003|Procedure|Nightime NIV initiation|In-hospital vs home
16017195|NCT02758990|Dietary Supplement|Vitamin A|Subjects will be asked to increase vitamin A intake by 8000 International Units per day.
16017196|NCT02758990|Dietary Supplement|Vitamin B6|Subjects will be asked to increase vitamin B6 intake by 50 mg per day.
16017197|NCT02758990|Dietary Supplement|Vitamin C|Subjects will be asked to increase vitamin C intake by 500 mg per day.
16017198|NCT02758990|Dietary Supplement|Nicotinamide|Subjects will be asked to increase Nicotinamide intake by 500 mg per day.
16017199|NCT02758990|Dietary Supplement|Vitamin D3|Subjects will be asked to increase Vitamin D3 intake by 1000 International Units per day.
16017200|NCT02758990|Dietary Supplement|Vitamin E|Subjects will be asked to increase vitamin E intake by 400 International Units per day.
16017201|NCT02758990|Other|Broccoli|Subjects will be asked to increase broccoli intake by 8 fluid ounces (~91 grams) per day.
16017202|NCT02758990|Other|Spinach|Subjects will be asked to increase spinach intake by 8 fluid ounces (~30 grams) per day.
16017203|NCT02758990|Dietary Supplement|Caffeine|Subjects will be asked to increase caffeine intake by taking 200mg caffeine orally once per day.
16017204|NCT02758990|Other|Coffee|Subjects will be asked to increase coffee intake by drinking 2 cups (177 mL each) of coffee per day.
16017205|NCT02758990|Device|Axon Eyewear|Subjects will be asked to utilize the therapeutic eyewear when exposed to bright or fluorescent light.
16017206|NCT02758990|Other|Chocolate|Subjects will be asked to increase chocolate intake by eating 57g per day.
16017207|NCT02758977|Procedure|ALPPS|For detailed information please refer to description of experimental arm
16017208|NCT02758977|Procedure|TWO STAGE HEPATECTOMY|For detailed information please refer to description of active comparator arm
16017209|NCT02758964|Other|MRI, neurocognitive Testing|A cerebral MRI and neurocognitive testing will be performed before TAVR, before hospital discharge and after 3 months
16017210|NCT02758951|Other|Perioperative systemic therapy|Neoadjuvant systemic therapy should start within four weeks after randomisation. Adjuvant systemic therapy should start within twelve weeks after CRS-HIPEC. In case of unacceptable toxicity or contraindications to oxaliplatin or irinotecan in the neoadjuvant setting, CAPOX or FOLFOX may be switched to FOLFIRI and vice versa. In case of unacceptable toxicity or contraindications to oxaliplatin in the adjuvant setting, CAPOX of FOLFOX may be switched to fluoropyrimidine monotherapy. Dose reduction, prohibited concomitant care, permitted concomitant care, and strategies to improve adherence are not specified a priori, but left to the discretion of the treating medical oncologist. Perioperative systemic therapy can be prematurely discontinued due to radiological or clinical disease progression, unacceptable toxicity, physicians decision, or at patients request.
16017211|NCT02758951|Combination Product|Perioperative CAPOX-bevacizumab|Four three-weekly neoadjuvant and adjuvant cycles of CAPOX (130 mg/m2 body-surface area [BSA] of oxaliplatin, intravenously [IV] on day 1; 1000 mg/m2 BSA of capecitabine, orally twice daily on days 1-14), with bevacizumab (7.5 mg/kg body weight, IV on day 1) added to the first three neoadjuvant cycles.
16017212|NCT02758951|Combination Product|Perioperative FOLFOX-bevacizumab|Six two-weekly neoadjuvant and adjuvant cycles of FOLFOX (85 mg/m2 body-surface area [BSA] of oxaliplatin, intravenously [IV] on day 1; 400 mg/m2 BSA of leucovorin, IV on day 1; 400/2400 mg/m2 BSA of bolus/continuous 5-fluorouracil, IV on day 1-2), with bevacizumab (5 mg/kg body weight, IV on day 1) added to the first four neoadjuvant cycles.
16017213|NCT02758951|Combination Product|Perioperative FOLFIRI-bevacizumab|Six two-weekly neoadjuvant cycles of FOLFIRI (180 mg/m2 body-surface area [BSA] of irinotecan, intravenously [IV] on day 1; 400 mg/m2 BSA of leucovorin, IV on day 1; 400/2400 mg/m2 BSA of bolus/continuous 5-fluorouracil, IV on day 1-2) and either four three-weekly (capecitabine (1000 mg/m2 BSA, orally twice daily on days 1-14) or six two-weekly (400 mg/m2 BSA of leucovorin, IV on day 1; 400/2400 mg/m2 BSA of bolus/continuous 5-fluorouracil, IV on day 1-2) adjuvant cycles of fluoropyrimidine monotherapy, with bevacizumab (5 mg/kg body weight, IV on day 1) added to the first four neoadjuvant cycles.
16017214|NCT02758951|Procedure|CRS-HIPEC, experimental arm|CRS-HIPEC is performed according to the Dutch protocol in all study centres. The choice of HIPEC medication (oxaliplatin or mitomycin C) is left to the discretion of the treating physician, since neither one has a favourable safety or efficacy. CRS-HIPEC should be performed within six weeks after completion of neoadjuvant systemic therapy, and at least six weeks after the last administration of bevacizumab in order to minimise the risk of bevacizumab-related postoperative complications.
16017215|NCT02758951|Procedure|CRS-HIPEC, control arm|CRS-HIPEC is performed according to the Dutch protocol in all study centres. The choice of HIPEC medication (oxaliplatin or mitomycin C) is left to the discretion of the treating physician, since neither one has a favourable safety or efficacy. CRS-HIPEC should be performed within six weeks after randomisation.
16017216|NCT02758938|Other|Urologic biofeedback software|All subjects (end users) will be walked through the urologic biofeedback software training suite. Each end user will follow a protocol that is specific to their role. Upon completing their session(s) with the software, each end user will provide appropriate feedback.
16017217|NCT02758925|Drug|Rituximab|375mg/m2 IV day 1
16017218|NCT02758925|Drug|Bendamustine|90mg/m2 IV day 1-2
16017518|NCT02756819|Drug|Azilsartan Medoxomil|Azilsartan medoxomil tablets
16017219|NCT02758925|Drug|Cytarabine|1000mg/m2 or 750mg/m2 at day 2 if patients aged more than 70 years or toxicity grade 3/4
16017220|NCT02758912|Drug|оral intake of study drug capsules; study drug - Cardionat ® (trimethylhydrazinium propionate dihydrate), oral capsules 250 mg|
16017221|NCT02758886|Behavioral|Animal assisted activity|Allowed to interact (e.g. talking, petting, scratching, feeding treats, playing with) live animals
16017222|NCT02758886|Behavioral|Animal photos|A 10 minute, silent, PowerPoint slide show of a variety of dogs and cats
16017223|NCT02758886|Behavioral|Observing human-animal interaction|Participants watched others participate in petting dogs and cats, while they waited in line for 10 minutes. Participants did not physically touch any animals during this time.
16017224|NCT02758873|Genetic|Personalised medicine (Salmeterol)|If participants require add-on medication and have the Gly/Gly variant on the ADRB2, salmeterol will be prescribed.
16017225|NCT02758873|Genetic|Personalised medicine (Montelukast)|If participants require add-on medication and have the Arg/Arg or Arg/Gly variant on the ADRB2, montelukast will be prescribed.
16017226|NCT02758873|Other|Standard care|If participants require add-on medication in the arm, they will be prescribed either salmeterol or montelukast according to health professional's choice based on current guidelines.
16017227|NCT02758860|Procedure|Colonoscopy|Patients will be submitted to diagnostic colonoscopy
16017228|NCT02758847|Device|Angiogram, Medtronic DCB (paclitaxel)/stent|Paclitaxel® coated balloons will be used for patients identified with Critical Limb Ischemia (CLI) and Tissue Loss. Each participant will receive angiogram with DCB (drug coated balloon)/stenting with wound debridement. 50% of subjects will receive an Angiogram, Medtronic DCB (paclitaxel)/stent. Tissue samples will be sent to pathology for specific staining to evaluate trace evidence of the drug paclitaxel.
16017229|NCT02758847|Device|Angiogram, Bard DCB (paclitaxel)/stent|Paclitaxel® coated balloons will be used for patients identified with Critical Limb Ischemia (CLI) and Tissue Loss. 50% of subjects will receive 'Angiogram, Bard DCB (paclitaxel)/stent' . Tissue samples will be sent to pathology for specific staining to evaluate trace evidence of the drug paclitaxel.
16017230|NCT02758821|Other|No CRP will be measured onsite|No CRP will be measured onsite
16017231|NCT02758821|Other|CRP cut-off of 20mg/L.|Health care worker will be given an advice to prescribe antibiotic to patient who has CRP lever < 20mg/L.
16017232|NCT02758821|Other|CRP cut-off of 40mg/L.|Health care worker will be given an advice to prescribe antibiotic to patient who has CRP lever < 40mg/L.
16017233|NCT02758795|Dietary Supplement|CONTROL|Following an overnight fast, participants submit to cannulation of a superficial arm vein from which are drawn serial samples of blood prior to and for 3 hours following ingestion of a prescribed protein 'shake'
16017234|NCT02758795|Dietary Supplement|NUTRIENT|Following an overnight fast, participants submit to cannulation of a superficial arm vein from which are drawn serial samples of blood prior to and for 3 hours following ingestion of a prescribed protein 'shake'
16017235|NCT02758782|Biological|Golimumab|
16017236|NCT02758782|Drug|Celecoxib|
16017237|NCT02758769|Biological|ORENCIA Subcutaneous Injection|
16017238|NCT02758756|Other|Massage|Treatments will be on a massage table and last up to 75 minutes. We do not specify what will occur during the massage treatments. Instead we will follow the model of relying on the professional expertise of the therapist in combination with input from the client to determine what should happen in the session. We specify that energy healing techniques not be used, because that is our research comparison condition. We also specify that conversation between the massage therapist and the patient be kept to the minimum necessary to effectively provide the treatment. This is not meant to be talk therapy.
16017239|NCT02758756|Other|Reiki|Reiki treatments will be provided by Reiki Masters on a massage table and last up to 75 minutes. We will not specify what will occur during the Reiki treatments. Instead we will follow the model of relying on the professional expertise of the therapist in combination with input from the client to determine what should happen in the session. That being said, we will ask that two specific things be kept to a minimum. The first is that we ask that Swedish massage techniques not be used, because that is our research comparison condition. The second is that conversation between the massage therapist and the patient be kept to the minimum necessary to effectively provide the treatment. This is not meant to be talk therapy.
16017240|NCT02758743|Drug|Acetium Lozenge|Slow-release L-Cysteine to block smoke.derived acetaldehyde in saliva thereby inhibiting the formation of harmans
16017241|NCT02758743|Drug|Placebo|Placebo with no active substance will not have the effect on intervention device.
16017242|NCT02758730|Biological|AFFITOPE® PD01A + Adjuvant|s.c. injection
16017243|NCT02758730|Biological|Adjuvant without active component|s.c. injection
16017244|NCT02758717|Drug|Brentuximab Vedotin|Given IV
16017245|NCT02758717|Biological|Nivolumab|Given IV
16017246|NCT02758704|Other|High stress|Generation of a stressful environment during a neonatal intubation procedure.
16017247|NCT02758704|Other|Low stress|Absence of stressful stimuli during neonatal intubation procedure
16017248|NCT02758704|Other|Endotracheal intubation on mannequin|Endotracheal intubation will take place at the simulation centre on a mannequin.
16017249|NCT02758691|Drug|Intranasal Insulin|All participants in the devise testing portion of the study will self-administer a 20 IU dose of intranasal insulin. Half of the participants in the function Magnetic Resonance Imaging portion of the study will also self-administer a 20 IU dose of intranasal insulin.
16017250|NCT02758691|Drug|Intranasal Saline|All participants in the devise testing portion of the study will self-administer a 20 mL dose of intranasal saline. Half of the participants in the function Magnetic Resonance Imaging portion of the study will also self-administer a 20 mL dose of intranasal saline.
16017251|NCT02758678|Biological|A single 2 ml heparinised peripheral blood sample|A single 2 ml heparinised peripheral blood sample was centrifuges to get serum specimens. Serum separation and Raman spectroscopy analysis:
16017252|NCT02758665|Drug|ibrutinib|
16017253|NCT02758665|Drug|obinutuzumab|
16017254|NCT02758665|Drug|venetoclax|
16017287|NCT02758444|Dietary Supplement|Micronutrient Powder (MNP) + 15 mg Zn|Children will have the supplement powder added to one meal on study day 1. Absorption of zinc from this meal will be measured using zinc stable isotope techniques.
16017288|NCT02758444|Dietary Supplement|MNP + 10 mg Zn|Same as above except MNP will contain 10 mg Zn
16087913|NCT02252042|Biological|cetuximab|
16017255|NCT02758639|Behavioral|Wonders & Worries Psychosocial Intervention|Session 1: Getting to Know Each Other The goal is to create a sense of safety within the group so that the children feel comfortable discussing difficult topics. Session 2: Cancer Education to provide developmentally appropriate education about the illness, treatment, and side effects. Session 3: Cancer Treatment Center Tour: This session consists of a treatment center tour and education about treatment plan involved in family's care in a safe environment. Session 4: Feelings: The focus of this session is expression and validation of all feelings the children may experience. Session 5: Stress and Coping: Goal is to emphasize the different ways individuals cope and differentiate positive vs. negative coping strategies. Session 6: Hopes for the Future/Closure: An emphasis is made on the idea that positive things may evolve from the most difficult circumstances.
16017256|NCT02758626|Drug|ataluren|Powder formulation
16017257|NCT02758626|Drug|Placebo|Powder formulation
16017258|NCT02758613|Drug|Baricitinib|Administered orally.
16017259|NCT02758613|Drug|Placebo|Administered orally.
16017260|NCT02758600|Other|Cycle ergometer exercise rehabilitation protocol|Patients will be submitted to a progressive and moderate exercise protocol with a portable cycle ergometer.
16017261|NCT02758587|Drug|Defactinib|cross reference with arm/group descriptions
16017262|NCT02758587|Drug|Pembrolizumab|cross reference with arm/group descriptions
16017263|NCT02758574|Procedure|CDT without ultrasound acceleration|A pulmonary arteriogram will be performed. Upon confirmation of the pulmonary embolus a standard infusion catheter will be placed within the clot. The catheter will be used for infusion of thrombolytics to treat/dissolve the pulmonary embolus.
16017264|NCT02758574|Procedure|CDT with ultrasound acceleration|A pulmonary arteriogram will be performed. Upon confirmation of the pulmonary embolus an infusion catheter that incorporates an ultrasound emitting wire will be placed within the clot. The catheter will be used for infusion of thrombolytics to treat/dissolve the pulmonary embolus. The wire will be connected to an ultrasound generating device.
16017265|NCT02758561|Behavioral|Workshop|"The first 15 minutes will be an information session on either Urinary Incontinence (UI) or Pelvic Organ Prolapse (PO) led by a Nurse Continence Advisor.
~The following 60 minutes will comprise a psychologist-led group discussion. The structured discussion will encourage participants to share experiences, thoughts, and feelings on pelvic floor disorders. Resistances and barriers to seeking treatment will be discussed. Decision-making processes will be explored.
~During the final 15 minutes, participants will be asked to complete a survey to evaluate the workshop. The survey will assess satisfaction with the information provided, quality of group discussion, comfort level with the group experience, and their satisfaction with the roles of the nurse continence advisor and psychologist."
16017266|NCT02758548|Procedure|Blood sample|Fingerprick and venous
16017267|NCT02758548|Device|POCT device|Investigational device
16017268|NCT02758535|Device|coaxial renal biopsy|In this method, a larger introducing needle is used for the puncture. The introducing needle is advanced just to the outer cortex of the kidney, and the needle angle is adjusted so that the needle pathway became mostly in the renal cortex, then the biopsy needle is inserted throughout the introducing needle and at least 4 cores are obtained. In this technique, the skin surface is punctured only once during the procedure.
16017269|NCT02758535|Device|noncoaxial renal biopsy|In this method, introducing needle is not used. Biopsy needle punctures the skin surface and the needle is advanced to about 10-15 mm into the renal cortex, and tissue sampling is done. After each sampling, the needle is removed and then for the next biopsy, the whole procedure is repeated until four cores being taken.
16017270|NCT02758522|Drug|Once-daily Insulin|Patients will receive NPH insulin in a once-daily regimen. The starting dose is calculate according to body mass index (BMI): 0.3 U/kg for BMI < 18 kg/m2, 0.4 U/kg for BMI 18-24.9 kg/m2, 0.5 U/kg for BMI 25-29.9 kg/m2 and 0.6 U/kg for BMI ≥ 30 kg/m2. The resulting dose will be fractioned to be given 60% as basal insulin (NPH) and 40% as prandial insulin (Regular). NPH insulin in the once-daily regimen will be administered subcutaneously before breakfast. Regular insulin subcutaneously wil be given in three equally divided doses before each meal.
16017271|NCT02758522|Drug|Twice-daily Insulin|Patients receive NPH insulin in twice-daily regimen. The starting dose is calculated according to body mass index (BMI): 0.3 U/kg for BMI < 18 kg/m2, 0.4 U/kg for BMI 18-24.9 kg/m2, 0.5 U/kg for BMI 25-29.9 kg/m2 and 0.6 U/kg for BMI ≥ 30 kg/m2. The resulting dose will de fractioned to be given 60% as basal insulin (NPH) and 40% as prandial insulin (Regular). NPH insulin in the twice-daily regimen will be administered subcutaneously before breakfast and before dinner. Regular insulin will be given in three equally divided doses before each meal.
16017272|NCT02758522|Drug|Triple-daily Insulin|Patients receive NPH insulin in a triple-daily regimen. The starting dose was calculated according to body mass index (BMI): 0.3 U/kg for BMI < 18 kg/m2, 0.4 U/kg for BMI 18-24.9 kg/m2, 0.5 U/kg for BMI 25-29.9 kg/m2 and 0.6 U/kg for BMI ≥ 30 kg/m2. The resulting dose will be fractioned to be given 60% as basal insulin (NPH) and 40% as prandial insulin (Regular). NPH insulin in the triple daily regimen will be administered subcutaneously before each meal. Regular insulin will be given in three equally divided doses before each meal.
16017273|NCT02758509|Drug|Pegylated interferon alfa-2a + Ribavirin|
16017274|NCT02758509|Drug|Pegylated interferon alfa-2a + Ribavirin + Boceprevir|
16017275|NCT02758509|Drug|Pegylated interferon alfa-2a + Ribavirin +Telaprevir|
16017276|NCT02758509|Drug|Ledipasvir/Sofosbuvir|
16017277|NCT02758509|Drug|Ombitasvir/paritaprevir/ritonavir+Dasabuvir|
16017278|NCT02758509|Drug|Daclatasvir+Sofosbuvir|
16017279|NCT02758509|Drug|Simeprevir+Sofosbuvir|
16017280|NCT02758496|Other|MeRT Efficacy Chart Review|There will be not intervention. This is a chart review.
16017281|NCT02758483|Other|Control diet|Diet with a little quantity of sugars (30.40g; 12.7% of total carbohydrates of the diet).
16017282|NCT02758483|Other|Test Diet|Diet with foods containing moderate quantity of sucrose in composition (80.22g; 30.2% of total carbohydrates of the diet).
16017283|NCT02758470|Drug|Acetazolamide|250 mg, taken orally three times per day
16017284|NCT02758470|Drug|Methazolamide|100mg, taken orally two times per day. A placebo pill will be taken between each dose of methazolamide to match the timing of doses and the number of pills between study arms.
16017285|NCT02758470|Other|Placebo|A placebo will be taken three times per day
16017286|NCT02758457|Device|dental crowns|
16017289|NCT02758444|Dietary Supplement|MNP + 5 mg Zn|Same as above except MNP will contain 5 mg Zn
16017290|NCT02758444|Dietary Supplement|MNP without Zn|Same as above except MNP will not contain Zn
16017296|NCT02758418|Other|TAO|"TAO is a self-applied online treatment program and consists on the computerized version of the traditional CBT protocol for Adjustment Disorders.
~The treatment protocol comprises different therapeutic components (see section Intervention) which are presented to the patients through 7 modules (one of them introductory). The Internet platform allows audiovisual resources (videos, illustrations, music and exercises that provide quick feedback) to be included, that makes the program more interactive."
16017297|NCT02758405|Drug|Bupivacaine|0.125% Bupivacaine plus fentanyl 2mcg/ml
16017298|NCT02758405|Drug|Fentanyl|0.125% Bupivacaine plus fentanyl 2mcg/ml
16017299|NCT02758405|Device|Infusion pump|Infusion pump set to deliver programmed intermittent epidural boluses (PIEB) plus patient-controlled epidural analgesia (PCEA).
16017300|NCT02758392|Drug|JNJ-61178104 Intravenous|Participants will receive JNJ-61178104 Intravenously on Day 1.
16017301|NCT02758392|Drug|JNJ-61178104 Subcutaneous|Participants will receive JNJ-61178104 Subcutaneously on Day 1.
16017302|NCT02758392|Drug|Placebo|Participants will receive placebo on Day 1.
16017303|NCT02758379|Device|Shockwave Coronary Lithoplasty System|Lithotripsy shockwaves are used to fracture calcified lesions in the coronary arteries
16017304|NCT02758366|Drug|Doxorubicin|
16017305|NCT02758353|Drug|Community distribution of SP|SP delivered at both the community and facility level by trained CBHVs in three LGAs.
16017306|NCT02758340|Drug|Misoprostol|Women would be given misoprostol tablet by mouth
16017307|NCT02758340|Device|foley's balloon catheter|foley's balloon catheter would be inserted through vagina into cervix.
16017308|NCT02758327|Drug|TheraTears Lubricating Eye Drops|Sodium Carboxy-methylcellulose 0.25% eye Lubricant
16017309|NCT02758314|Other|Evaluation of PD-1/PDL-1 expression.|Evaluate the expression of PD-1 / PD-L1 on T-cell subpopulations of peripheral blood by flow cytometry and in tumor tissue by immunohistochemistry in NSCLC, free treatment and healthy subjects
16017310|NCT02758301|Device|Reveal LINQ™ Insertable Cardiac Monitor (ICM)|Insertable Cardiac Monitor with LINQ™ HF Investigational RAMware download
16017311|NCT02758288|Other|New Protocol - BK viremia or BK virus nephropathy|Data collected prospectively that will follow new clinical practice guidelines that were developed by Loma Linda Nephrology group with collaboration with Transplant surgeons to improve care of patients complicated with BK viremia or BK virus nephropathy.
16017312|NCT02758288|Other|Standard Protocol - BK viremia or BK virus nephropathy|Data collected retrospectively that followed standard clinical practice guidelines that were developed by Loma Linda Nephrology group with collaboration with Transplant surgeons to improve care of patients complicated with BK viremia or BK virus nephropathy.
16017313|NCT02758275|Behavioral|Teaching: Individual (5606)|"Usual care and Teaching: Individual (5606): It consists of 6 educational sessions:
~Behavior Modification (4360) Promotion of a behavior change.
~Teaching Disease Process (5602) Assisting the patient to understand information related to a specific disease process.
~Teaching: Prescribed Medication (5616) Preparing a patient to safely take prescribed medications and monitor for their effects.
~Teaching: Prescribed Diet (5614) Preparing a patient to correctly follow a prescribed diet.
~Teaching: Prescribed Exercise (5612) Preparing a patient to achieve and/or maintain a prescribed level of activity.
~Coping Enhancement (5230) Assisting a patient to adapt to perceived stressors, changes, or threats that interfere with meeting life demands and roles."
16017314|NCT02758262|Device|Noninvasive brain stimulation|
16017315|NCT02758249|Drug|Sevoflurane|patients are anesthetized by using sevoflurane inhalation
16017316|NCT02758249|Drug|propofol|patients are anesthetized by using propofol infusion
16017317|NCT02758236|Other|No Intervention|No Intervention
16017318|NCT02758223|Biological|TCM allogeneic humane central memory T cells, cryopreserved|Experimental: TCM allogeneic humane central memory T cells, cryopreserved Solution for injection (intravenous use) up to 65*10^4 TCM /kg body weight patient will receive investigational product 3 times (Day 30, Day 60, Day 90 after alloHSCT)
16017319|NCT02758210|Device|Use of a Tablet|Testing of the electromagnetic field exposure and it's affect on the participant's previously implanted MICRA device is assessed by interrogation of the device before using Tablet and while using the Tablet. The measured position of the Tablets tested will be normal routine position (noting at least 6 inches/15 centimeters from their pacemaker).
16017320|NCT02758210|Device|Use of a Smart Phone|Testing of the electromagnetic field exposure and it's affect on the participant's previously implanted MICRA device is assessed by interrogation of the device before using a Smart phone and while using the Smart phone. The position of the Smart phone tested will be normal position at the ear and while texting (noting at least 6 inches/15 centimeters from their pacemaker).
16017321|NCT02758197|Behavioral|Mindfulness-Based Stress Reduction (MBSR)|Participants assigned to this group will be enrolled in an Mindfulness-Based Stress Reduction (MBSR) course directly following medical treatment optimization. The MBSR course consists of eight weekly 2-hour sessions and one 6 hour session midway through the course and involves psychoeducation, relaxation techniques, gentle stretching (very mild form of yoga), and different forms of meditation. Participants will learn ways to better cope with their pain and the disability and distress related to it with a goal of reducing the stress response that is our body's normal reaction to pain. All sessions will be conducted by a psychologist or social worker with a minimum of 2 years of experience in chronic pain management, formal MBSR training and 2 years of experience leading MBSR groups.
16017322|NCT02758184|Device|ROTEM-based coagulation monitoring|
16017323|NCT02758171|Drug|Empagliflozin|
16017324|NCT02758171|Drug|Linagliptin|
16017354|NCT02757950|Biological|Combined diphtheria, tetanus and tricomponent acellular pertussis vaccine [Refortrix (Tdap)]|Subjects were included in the Exposed cohort if they received Refortrix as part of the maternal immunization program in Brazil.
16017519|NCT02756806|Device|Picosecond Q-switched laser|Each subject will receive up to 6 laser treatments.
16017325|NCT02758158|Device|Tri-modal imaging|This trimodal imaging system was developed in collaboration with Sogang University and is composed of three subsystems: ultrasound, photoacoustic and fluorescence. For this study, the fluorescence subsystem will not be used. The photoacoustic and ultrasound subsystems and data acquisition are controlled by a single workstation. The complete system is Canadian Standards Association (CSA) certified.
16017326|NCT02758145|Other|Flu vaccination information in 3 phases|"An oral information is given by the nurse during the recruitment visit at the occupational medicine unit. She initiates the discussion on flu and asks the employee if he usually receives the vaccine. Then she provides a brief standardized information on recommendations concerning flu vaccination, and the annual influenza vaccination campaign in CHUV and PMU. She responds to questions.
~After the interview, she gives an informative document with key messages (information about the disease, benefits to be vaccinated, vaccine safety, etc.). The document includes frequently asked questions, website address, and the email address of the occupational medicine unit in case of questions.
~The third phase consists of sending to the employee shortly after the start of the next campaign of flu vaccination (November 2016), a postal mail recalling the information provided during the recruitment examination and inviting them to get vaccinated."
16017327|NCT02758132|Biological|Denosumab|One 120 mg subcutaneous injection every four weeks. Protocol therapy will consist of 28-day cycles until no clinical benefit, confirmed disease progression or unacceptable toxicity.
16017328|NCT02758132|Drug|Enzalutamide|160 mg enzalutamide by mouth daily
16017329|NCT02758132|Drug|Abiraterone|1000 mg abiraterone by mouth daily
16017330|NCT02758132|Drug|Prednisone|5 mg prednisone by mouth twice daily
16017331|NCT02758119|Other|Serious Game|
16017332|NCT02758119|Other|Online course|
16017333|NCT02758106|Device|Vest Airway Clearance System Model 105|HFCWO for 15 minutes then sputum suction.
16017334|NCT02758106|Device|placebo intervention|CCPT for 15 minutes then sputum suction.
16017335|NCT02758093|Behavioral|Speed of Processing Training|These are specific computerized exercises that are designed to increase the rate in which people can process visual information.
16017336|NCT02758093|Other|Internet Navigational|This is a sham condition in which participants will receive the same amount of social and computer contact as those randomized to receive the 10 hours of speed of processing training. In this condition, participants will learn how to do various activities on the internet.
16017337|NCT02758080|Other|Matching on the basis of molecular analysis|
16017338|NCT02758080|Other|Matching on the basis of physician's choice|
16017339|NCT02758067|Drug|brexpiprazole|2- 4 mg/day, tablets, oral, 28-weeks
16017340|NCT02758067|Drug|risperidone|4-6 mg/day, tablets, oral, 28-weeks
16017341|NCT02758054|Behavioral|Patient Navigation|Patient navigated reminder calls containing information about screening appointments, reminders, hints to facilitate communication with physicians, and smoking cessation.
16017342|NCT02758041|Device|Sebacia Microparticles|
16017343|NCT02758028|Behavioral|Brief counseling|"Peer counselling is delivered based on the queries and the needs of individual clients, according to the smoking status, dependency level and the perceived barriers of each individual with the use of motivational intervention approach.
~The subjects will be followed up at 1-week, 1-, 3-, 6-, 9-, 12- and 24-month via telephone assessing their smoking status and reinforce intervention."
16017344|NCT02758015|Other|Standardized Meal|
16017345|NCT02758015|Dietary Supplement|Betaine Hydrochloride 1500mg|Betaine hydrochloride (natural supplement) administered after standardized meal.
16017346|NCT02758015|Dietary Supplement|Betaine Hydrochloride 3000mg|Betaine hydrochloride (natural supplement) administered after standardized meal.
16017347|NCT02758015|Dietary Supplement|Betaine Hydrochloride 4500mg|Betaine hydrochloride (natural supplement) administered after standardized meal.
16017348|NCT02758002|Procedure|Firm ablation for transitional AF rotors|Transitional AF rotors will be mapped and ablated as part of this study. All subjects will undergo this ablation after standard PVI and Firm ablation for sustained rotors.
16017349|NCT02757989|Other|transplantation|allogeneic hematopoietic stem cell transplantation in patients with donor
16017350|NCT02757976|Device|Conventional CRT|Patients randomized to the Conventional CRT will receive a CRT device with or without ICD. Device implantation will be performed within 10 working days of randomization. Conscious sedation or general anesthesia can be used for the implant procedure. The device will be implanted in a facility that has the capacity to perform coronary sinus venography at the time of implantation. The RA lead will be placed in the RA appendage or high RA. The RV lead should be placed at the RV apex or distal RV septum (R wave > 7 mV, pacing threshold < 1.5 V at a pulse-width of 0.5 ms). The LV lead should be positioned through the CS to an LV branch. The lead should be placed at one of the left ventricular venous branches, avoiding the LV apex and scar region identified by pre-implant imaging.
16017351|NCT02757976|Device|LV endocardial CRT|Patients randomized to LV endocardial CRT will receive a CRT device with or without ICD, placed in the same time frame, and will have RA and RV leads implanted as the conventional CRT group. The device will be implanted in a facility that has the capacity to perform trans-atrial septal puncture with ultrasound guidance (TEE or ICE) at the time of implantation. The LV lead will be placed using a trans-atrial septal approach, using a specially designed puncture tools and LVendo delivery tool kits specifically designed for this study. Special care will be taken to avoid the LV apex and transmural scar identified by pre-implant imaging.
16017352|NCT02757963|Other|Benign prostatic enlargement (BPE)/Benign prostatic obstruction (BPO) screening tool|The BPE/BPO screening tool has been developed using the currently recommended Food and Drug Administration (FDA) 2009 guidelines for developing patient-completed questionnaires such as Patient Reported Outcomes. The tool to be used in this study in the General Practice setting has undergone validation in a urology setting to demonstrate the validity of the tool in populations with and without a definite diagnosis of BPH. Subjects who have a positive score on the BPE/BPO screening tool (total score >=3) and meet all other eligibility requirements will be enrolled in Part I of the study.
16017353|NCT02757963|Other|International Prostate Symptom Score (IPSS) screening tool|The International Prostate Symptom Score (IPSS) score is a validated tool to assess the severity of LUTS symptoms, and has similarly been used for assessing symptomatic efficacy of treatments for BPH. Subjects who have a positive score on the IPSS tool (score >=8) and meet all other eligibility requirements will be enrolled in Part I of the study.
16017410|NCT02757573|Procedure|Hypercarbia|PaCO2 is elevated from 5 to 7.5 kPa by controlled ventilation.
16017355|NCT02757937|Behavioral|Health & Wellness Website|Educational website for patients with chronic disease (i.e., Type 2 diabetes, asthma, high blood pressure, high cholesterol). The website is a free interactive resource to help patients manage their health condition(s) each day and to help them achieve their goals. It is a multichannel health and wellness platform to help patients adhere to their treatment and care plans between office visits.
16017356|NCT02757937|Other|Control Arm|Continue with standard diabetes care without getting access to the intervention website.
16017357|NCT02757924|Other|Infant formula supplemented with prebiotics|Sole source nutrition
16017358|NCT02757911|Genetic|X vivo gene therapy|Transplantation of patient's autologous CD34+ cells transduced with lentiviral vector containing XCGD gene. The investigational product is patient-specific and corresponds to autologous CD34+ cells transduced ex vivo with the G1XCGD vector. These transduced cells will be cryopreserved until safety testing and infusion into the patient.
16017359|NCT02757898|Drug|Biotin-Labeled Red Blood Cells (RBCs)|"500mL of blood will be drawn from each participant. The blood will be processed into a packed RBC unit.
~For participants 1 and 2, the RBCs will be labeled with biotin at three pre-defined concentrations of biotin labeling reagent (2, 6, 18 µg/mL of RBCs) and the labeled RBCs will be re-infused into the participant on the same day of collection.
~For participants 3 through 8, the RBCs will be stored at 2-6C for 40-42 days before being labeled with three pre-defined concentrations of biotin labeling reagent (2, 6, 18 µg/mL of RBCs) and re-infused into the participant.
~Participants will have a 5 mL blood sample drawn within a few minutes of the re-infusion, the day after the re-infusion and then weekly for 70 days (10 weeks) to track the survival of the infused biotin labeled RBCs."
16017360|NCT02757885|Procedure|Bone Marrow Transplant (BMT)|Participants will receive a bone marrow infusion from a human leukocyte antigen (HLA) matched donor through a central venous catheter.
16017361|NCT02757885|Procedure|Bone Marrow Harvest (Donation)|The donation of bone marrow is a surgical procedure in which bone marrow is removed from the back of both of the hip bones through a large, hollow needle. At least two small cuts (less than ¼ inch) will be made in the skin to put the needle into the bone. Many small samples are collected through the needle into syringes. The total amount of marrow take will be up to ¼ ounce of marrow per pound. Bone marrow harvest is done under general anesthesia. Participants will be in the hospital for 8 to 10 hours.
16017362|NCT02757885|Drug|Hydroxyurea|Hydroxyurea is part of the bone marrow transplant preparative regimen. Hydroxyurea will be administered at a dose of 30 mg/kg orally as a single daily dose for 90 days (from day -100 to day-10). Hydroxyurea dosing will be based on adjusted body weight in participants weighing >125% ideal body weight.
16017363|NCT02757885|Drug|Thiotepa|Thiotepa is part of the bone marrow transplant preparative regimen. Thiotepa will be administered at a dose of 10mg/kg intravenously (IV) over 2 hours or per institutional guidelines on day -7. Thiotepa dosing will be based on adjusted body weight in patients weighing >125% ideal body weight.
16017364|NCT02757885|Drug|Fludarabine monophosphate|Fludarabine is part of the bone marrow transplant preparative regimen. Fludarabine 30 mg/m2/day will be administered from day -7 to day -3 (for a total of 150 mg/m2 over 5 consecutive days) and administered intravenously (IV) over a minimum of 30 minutes. In participants weighing > 125% ideal body weight, fludarabine will be dose based upon adjusted body weight.
16017365|NCT02757885|Drug|Cyclophosphamide|"Cyclophosphamide is part of the bone marrow transplant preparative regimen. Cyclophosphamide will be administered on days -6 and -5 prior to bone marrow infusion at a dose of 14.5 mg/kg intravenously (IV) infused over 1-2 hours.
~Post bone marrow infusion cyclophosphamide will be infused on days +3 (between 60 and 72 hours post marrow infusion) and +4 (approximately 24 hours after day +3 dose) at a dose of 50 mg/kg IV infused over 1-2 hours.
~For participants weighing more than 125% of their ideal body weight, dosing will be based on adjusted ideal body weight."
16017366|NCT02757885|Other|Rabbit Anti-thymocyte Globulin|Rabbit anti-thymocyte globulin (ATG) is part of the bone marrow transplant preparative regimen. It is an infusion of rabbit-derived antibodies against human T cells used for prevention of acute rejection in organ transplantation. Rabbit ATG will be administered on day -9 at 0.5 mg/kg and on days -8 and -7 at 2 mg/kg (for a total dose 4.5 mg/kg).
16017367|NCT02757885|Radiation|Total Body Irradiation|Participants will receive 200 cGy of TBI in a single fraction.
16017372|NCT02757859|Procedure|Pancreatectomy|Undergo pancreaticoduodenectomy, distal pancreatectomy, or total pancreatectomy
16017373|NCT02757859|Other|Lavage|Receive extensive intraoperative peritoneal saline (EIPL-S) lavage
16017374|NCT02757833|Other|A 3 Tesla MRI scanner (Siemens, Erlangen Germany), will be used to measure levels of GSH in the brain.|Using the MEGA-PRESS pulse sequence, high resolution T1-weighted sagittal anatomic images covering the brain using an inversion-prepared MP-RAGE pulse sequence to produce high grey/white matter contrast will be acquired. These will be used to localize the spectroscopy voxel in the vmPFC. Magnetic field homogeneity will be optimized in the voxel using an automated map shimming procedure. MEGA-PRESS spectra will be acquired to detect the glutathione cysteinyl ß-CH2 peak at 2.95 ppm with the editing pulse set at the j-coupled a-CH resonance at 4.95 ppm. A reference unsuppressed water spectrum will be acquired for absolute quantification. Metabolite spectra will be fitted in the time domain using a Levenberg-Marquardt least squares minimization routine. The contribution of each metabolite to the in-vivo spectrum can be scaled to the water signal intensity from within the voxel of interest to obtain an absolute measurement of metabolite concentration.
16017375|NCT02757820|Device|LMA Classic|Patients will be anesthetized using Classic laryngeal mask airway that will be inserted lubricated with partially deflated cuff. After insertion, the cuff will be inflated with the recommended volume of air.
16017376|NCT02757820|Device|i- gel|Patients will be anesthetized using I-gel LMA with its lubricated cuff inserted along the hard palate until resistance is felt, as recommended by the manufacturer.
16017377|NCT02757820|Device|Air-Q|Patients will be anesthetized using Air-Q_ ILA, with its lubricated cuff inserted along the hard palate until resistance is felt, as recommended by the manufacturer.
16017411|NCT02757560|Other|SFA diet|SFA versus control diet
16017378|NCT02757807|Behavioral|Utilization of Serenita for Relaxation|Users to use Serenita daily and before sexual interaction in order to assess stress and reduce it
16017379|NCT02757794|Other|computerized cognitive remediation program|a computer program online re-educating the working memory is completed by the parents and the child. The child made a series of interactive exercises accompanied by parents or a practitioner. The exercises are adapted automatically and individually to the performance at each session.
16017380|NCT02757794|Other|standard remediation|A speech therapy and / or academic support is realized.
16017381|NCT02757781|Behavioral|Community of Practice|The intervention group will be offered participation for 12 months in a virtual CdP based on a web 2.0 platform. The control group will receive usual training.
16017382|NCT02757768|Drug|Mirabegron|Participants received initial dose of 25 mg of mirabegron (oral tablet) which was increased to 50 mg after 4 weeks.
16017383|NCT02757768|Drug|Placebo|Participants received initial dose of 25 mg of matching placebo (oral tablet) which was increased to 50 mg after 4 weeks.
16017384|NCT02757768|Drug|Tamsulosin Hydrochloride|Participants received once daily treatment with tamsulosin hydrochloride 0.4 mg (oral tablet) throughout the study.
16017385|NCT02757755|Biological|AB-SA01 (10^8 PFU per phage)|Gauze pads will be saturated with AB-SA01 and then applied to each subject's volar forearm and covered with occlusive dressing once daily for 3 consecutive days. Placement of the gauze to each subject's right or left volar forearm will be randomized and double-blinded.
16017386|NCT02757755|Biological|AB-SA01 (10^9 PFU per phage)|Gauze pads will be saturated with AB-SA01 and then applied to each subject's volar forearm and covered with occlusive dressing once daily for 3 consecutive days. Placement of the gauze to each subject's right or left volar forearm will be randomized and double-blinded.
16017387|NCT02757755|Biological|Placebo (for Cohort 10^8)|Gauze pads will be saturated with Placebo and then applied to each subject's volar forearm and covered with occlusive dressing once daily for 3 consecutive days. Placement of the gauze to each subject's right or left volar forearm will be randomized and double-blinded.
16017388|NCT02757755|Biological|Placebo (for Cohort 10^9)|Gauze pads will be saturated with Placebo and then applied to each subject's volar forearm and covered with occlusive dressing once daily for 3 consecutive days. Placement of the gauze to each subject's right or left volar forearm will be randomized and double-blinded.
16017389|NCT02757729|Drug|PAC-14028 cream 0.1%|Topical application
16017390|NCT02757729|Drug|PAC-14028 cream 0.3%|Topical application
16017391|NCT02757729|Drug|PAC-14028 cream 1.0%|Topical application
16017392|NCT02757729|Drug|PAC-14028 cream vehicle|Topical application
16017393|NCT02757716|Other|Questionnaire|Every patient who undergo surgery will fill out a questionnaire containing validated scales concerning food, alcohol, nicotine, internet and exercise and drug addiction prior, 6 months and 24 months after surgery.
16017394|NCT02757703|Drug|Somatostatin|A decision to use vasoactive drugs (either somatostatin or terlipressin) depended on the favorite of participating attending physicians who were requested to fill out the enclosed questionnaires immediately after the administration of the first dose for further understanding the underlying reason of the chosen medication.
16017395|NCT02757703|Drug|Terlipressin|A decision to use vasoactive drugs (either somatostatin or terlipressin) depended on the favorite of participating attending physicians who were requested to fill out the enclosed questionnaires immediately after the administration of the first dose for further understanding the underlying reason of the chosen medication.
16017396|NCT02757703|Drug|Pantoprazole|Both study groups were administered with 40mg pantoprazole intravenously after EVL for 3 days, and following oral form for 12 days to hasten the process of healing of ulcers induced by ligation.
16017397|NCT02757703|Device|Endoscopic variceal ligation|Two experienced endoscopists performed emergent EVL for the enrolled patients with acute EVB. Pneumoactive ligation device (Sumitomo Bakelite Co., Ltd, Tokyo, Japan) and endoscopes (GIF XQ260; Olympus Co. Ltd, Tokyo, Japan) were applied. The targeted varix was suctioned and entrapped by a cap on endoscope. Ligation was aimed at active bleeding sites, red color spots or white nipple signs during the procedure.
16017398|NCT02757690|Device|3-dimensional distal pancreatectomy|3D laparoscopy
16017399|NCT02757690|Device|2-dimensional distal pancreatectomy|2D laparoscopy
16017400|NCT02757677|Device|Optical Coherence Tomography based Angiography|A contrast-free, noninvasive technology to identify blood vessels in the eye
16017401|NCT02757664|Device|Shock Wave Therapy|Appliance of radial shock waves with the BLT600 equipment (BTL Medical Technologies - Canada), the intensity being 2000 to 3000 pulses, 7 to 10Hz of frequency, and 1,5 a 2,5Bar of intensity per application; Appliance on the first day of treatment (D0), repeated on the second week after the first intervention (2nd week) and four weeks after the first intervention (4th week).
16017402|NCT02757664|Other|Eccentric Exercises|12 weeks, starting on the same day of the first appliance. The patient will practice the exercises standing on tiptoes and will perform exercises of passive ankle extension (dorsiflexion), three series of 15 repetitions, with the knee stretched, and three series of 15 repetitions with the knee flexed by 20 degrees.
16017403|NCT02757664|Device|Placebo|Placing of the apparatus´ therapeutic head with the support that impedes the shock wave propagation directly on the appliance field; Appliance of radial shock waves with the BLT600 equipment (BTL Medical Technologies - Canada), the intensity being 2000 to 3000 pulses, 7 to 10Hz of frequency, and 1,5 a 2,5Bar of intensity per application; Appliance on the first day of treatment (D0), repeated on the second week after the first intervention (2nd week) and four weeks after the first intervention (4th week).
16017404|NCT02757651|Drug|Hydrogen Peroxide|Hydrogen Peroxide
16017405|NCT02757638|Other|Stable isotope infusion|such as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline
16017406|NCT02757625|Drug|Dexmedetomidine hydrochloride|"45 weeks CGA to < 6 years old: Maintenance infusion will be started at 0.2 µg/kg/h. The infusion rate will be adjusted within a range of 0.2 to 1.4 µg/kg/h according to the pediatric subject's sedative state
~6 years old to < 17 years old: Maintenance infusion will be started at 0.2 µg/kg/h. The infusion rate will be adjusted within a range of 0.2 to 1.0 µg/kg/h according to the pediatric subject's sedative state"
16017407|NCT02757612|Radiation|laser diode|laser diode
16017408|NCT02757599|Other|Ultrasound training|Training on the transvaginal ultrasound simulator.
16017409|NCT02757586|Genetic|shRNA|Using shRNA interfered the expression of the gene of CLL
16088071|NCT02251132|Drug|TPV high 1|
16017414|NCT02757547|Device|Transcranial magnetic stimulation - Placebo Arm|Each seizure patient (subject) will receive 5 days in a row the placebo (sham) magnetic stimulation using the placebo (sham) coil of the STM9000 Transcranial Magnetic Stimulator. This involves magnetic stimulation at 90% of the resting motor threshold at 1 Hz in three 500-pulse blocks, separated by 10-minute breaks for 1500 pulses total. The placebo coil produces the same noise and movement as an active coil, but doesn't deliver any magnetic stimulation.
16017415|NCT02757547|Device|Transcranial magnetic stimulation - Active Arm|Each seizure patient (subject) will receive 5 days in a row of active magnetic stimulation using the active TMS coil of the STM9000 Transcranial Magnetic Stimulator. This involves magnetic stimulation at 90% of the resting motor threshold at 1 Hz in three 500-pulse blocks, separated by 10-minute breaks for 1500 pulses total.
16017416|NCT02757534|Drug|Domperidone|The study drug will be given to relieve the symptoms of gastroparesis, including nausea and vomiting.
16017417|NCT02757521|Drug|Nitrous Oxide|50% nitrous oxide/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)
16017418|NCT02757521|Drug|Placebo|50% nitrogen {inert}/ 50% oxygen, 3 one hour inhalation treatments per Stage, every other day (M,W,F)
16017419|NCT02757508|Dietary Supplement|protein powder supplement|
16017420|NCT02757508|Dietary Supplement|Vitamins/minerals|
16017421|NCT02757495|Drug|Dexmedetomidine|Single dose caudal epidural injection will be done using 25 G needle. patients of Group BD will be given dexmedetomidine (precedex 100 µg/mL parenteral preparation (Hospira ® ) 2 µg/kg in 1 ml/kg bupivacaine 0.25%,
16017422|NCT02757482|Other|training|
16017423|NCT02757469|Drug|Drospirenone and ethinyl estradiol combination (Yasmin)|Female oral combined contraceptive containing 30 mcg (0.030 mg) Ethinyl Estradiol and 3 mg drospirenone (Androstenes)
16017424|NCT02757456|Behavioral|Aerobic Exercise program|The 16-week program will consist of aerobic-type steady-state or interval exercises using a pedals attachable to the dialysis chairs. The purpose will be to slowly increase exercise duration by 5 minute increments to reach the goal of 30 min/treatment. The exercise program during hemodialysis sessions will contain a combination of aerobic and flexibility exercises, about 30 minutes of cycling with 10 minutes of warm up/stretching exercises and 10-15 minutes cool down. The frequency of exercise will be three sessions a week, during the first hour of dialysis treatment for the duration of 16 weeks. Blood pressure and heart continuous monitoring will be carried out during the exercise program. Exercise log sheets will be filled for each session for the 16 weeks.
16017425|NCT02757456|Other|Control|No aerobic exercise is offered but baseline and end of study testing of the outcomes occur
16017426|NCT02757443|Drug|Phosphocreatine sodium tetrahydrate after anaesthesia induction|after anaesthesia induction 2 g of Phosphocreatine (PCr) prepared in 50 mL of glucose 5% during 30 min intravenous (IV)
16017427|NCT02757443|Drug|5% Glucose after anaesthesia induction|after anaesthesia induction 50 mL of glucose 5% IV delivered by an identical infusion pump during 30 minutes
16017428|NCT02757443|Drug|Phosphocreatine sodium tetrahydrate added to cardioplegia|together with cardioplegia 2.5 g of PCr prepared in 50 mL of glucose 5% and added to every 1 L of cardioplegic solution (Custodiol, Dr. F. KOHLER CHEMIE, GmbH, Germany; concentration = 10 mmol/L)
16017429|NCT02757443|Drug|5% Glucose|together with cardioplegia 50 mL of glucose 5% is added in every 1 L of cardioplegic solution (Custodiol, Dr. F. KOHLER CHEMIE, GmbH, Germany)
16017430|NCT02757443|Drug|Phosphocreatine sodium tetrahydrate after heart recovery|immediately after heart recovery (spontaneous or paced myocardium contraction) after aorta declamping 2 g of PCr prepared in 50 mL of glucose 5% during 30 min IV
16017431|NCT02757443|Drug|5% Glucose after heart recovery|immediately after heart recovery (spontaneous or paced myocardium contraction) after aorta declamping 50 mL of glucose 5% IV delivered by an identical infusion pump during 30 minutes
16017432|NCT02757443|Drug|Phosphocreatine sodium tetrahydrate after ICU admission|immediately after ICU admission 4 g of PCr in 100 mL of glucose 5% during 60 min IV
16017433|NCT02757443|Drug|5% Glucose after ICU admission|immediately after ICU admission 100 mL of glucose 5% IV delivered by an identical infusion pump during 60 minutes
16017434|NCT02757430|Procedure|Cardiac Ablation|
16017435|NCT02757417|Drug|sodium fluorescein|
16017436|NCT02757417|Drug|phenazopyridine|
16017437|NCT02757404|Drug|Ultrasonography guidance injection of Meditoxin®.|Meditoxin® will be injected to upper limb spasticity by using the ultrasonography guidance.
16017438|NCT02757404|Drug|Electrical stimulation guidance injection of Meditoxin®.|Meditoxin® will be injected to upper limb spasticity by using the electrical stimulation guidance.
16017439|NCT02757404|Drug|Manual needle placement injection of Meditoxin®.|Meditoxin® will be injected to upper limb spasticity by using the manual needle placement.
16017440|NCT02757391|Biological|Adoptive Immunotherapy|Undergo CD8 +T cell therapy
16017441|NCT02757391|Biological|Aldesleukin|Given SC
16017442|NCT02757391|Drug|Cyclophosphamide|Given IV
16017443|NCT02757391|Other|Laboratory Biomarker Analysis|Correlative studies
16017444|NCT02757391|Biological|Pembrolizumab|Given IV
16017445|NCT02757378|Procedure|Neuroplasticity Explanation (Experimental)|Patients were given an explanation of how the brain uses the information from a manual therapy technique to help it remain sharp in identifying where this input is coming from.
16017446|NCT02757378|Procedure|Biomechanical Explanation (Control)|Patients were given an explanation of how the manual therapy technique affects the anatomy and physiology of the back.
16017447|NCT02757365|Drug|aspirin|
16017448|NCT02757365|Drug|Levofloxacin|
16017449|NCT02757352|Drug|Ixekizumab|Administered SC
16017450|NCT02757352|Drug|Placebo|Administered SC
16017451|NCT02757326|Drug|Opaganib|Opaganib, [3-(4-chlorophenyl)-adamantane-1-carboxylic acid (N-(Pyridin-4-ylmethyl)pyridine-4-carboxamide) amide, hydrochloride salt] is an orally available inhibitor of the enzyme SK2.
16017452|NCT02757313|Drug|Low dose THC marijuana|
16017453|NCT02757313|Drug|High dose THC marijuana|
16017454|NCT02757313|Drug|Placebo marijuana|
16017455|NCT02757300|Device|Hypopharyngeal packing|After introduction and orotracheal intubation a hypopharyngeal packing soaked with Chlorhexidinbis (D-gluconat) is placed.
16017456|NCT02757300|Device|Without Hypopharyngeal packing|After introduction and orotracheal intubation the patient will pass the operation without hypopharyngeal packing with a short tip coming out the mouth to imitate a packing.
16017457|NCT02757287|Drug|FSH-CTP + DESOGESTREL|"Hormones measured on day of 7th menstrual cycle day , day of pre-ovulatory bolus of GnRH and the day after the bolus ( estradiol, FSH, Progesterone, LH)
~- Quality of Life questionnaire the day after the bolus"
16017458|NCT02757261|Device|Laser|Low-level laser therapy administrated to acupoints
16017459|NCT02757261|Device|Occlusal splint|Occlusal splint with expander
16017460|NCT02757261|Device|Placebo laser|Placebo laser (Low-level laser therapy administrated to acupoints)
16017461|NCT02757248|Drug|Volasertib|Volasertib 75-150mg/m2 given intravenously on days 1 and 8
16017462|NCT02757248|Drug|Romidepsin|Romidepsin 12-14mg/m2 given intravenously on days 1, 8 and 15
16017463|NCT02757235|Procedure|Irrigation fluid of body temperature|Irrigation fluid of body temperature will be used during burr hole evacuation of chronic subdural hematoma
16017464|NCT02757235|Procedure|Irrigation fluid of room temperature|Irrigation fluid of room temperature will be used during burr hole evacuation of chronic subdural hematoma.
16017465|NCT02757222|Radiation|Escalated Dose|"Boost Target Volume (BTV): The PET CT GTV (thresholding at 40% of SUV max) with a 3mm margin will form the BTV.
~CTV1: A 3mm area around the BTV avid primary or 2mm area around the node will form the CTV1.
~CTV 2: This (CTV 2) includes the area around the primary or nodal levels at risk of harbouring microscopic primary or microscopic nodal metastatic disease and not already included in CTV1.
~Planning Target Volume: PTV - A margin of 5mm will be added to each of the CTV to obtain the PTV.
~BTV receives 73.5Gy in 30 fractions. PTV 1 receives 63Gy in 30 fractions. PTV 2 receives 54 Gy in 30 fractions.
~All patients receive concurrent platinum chemotherapy."
16017466|NCT02757222|Radiation|Standard Dose|"CTV 1 includes 6mm isotropic margin around the entire PET-CT avid (thresholding at 40% of SUV max) larynx/ hypopharynx /oropharynx and 5mm isotropic margin around nodes.
~CTV 2: This (CTV 2) includes the area around the primary or nodal levels at risk of harbouring microscopic primary or microscopic nodal involvement, or at risk nodal areas, and not already included in CTV1.
~Planning Target Volume: PTV - A margin of 5mm will be added to each of the CTV to obtain the PTV.
~PTV 1 receives 66Gy in 30 fractions. PTV 2 receives 54 Gy in 30 fractions.
~All patients receive concurrent platinum chemotherapy."
16017467|NCT02757209|Device|Spiromax (budesonide/formoterol)|"DuoResp Spiromax 160 (160 micrograms budesonide/4.5 micrograms formoterol fumarate dihydrate), either one inhalation twice a day (morning and evening) or two inhalations twice a day (morning and evening), for 1 week.
~Additional 8 weeks in one subgroup"
16017468|NCT02757209|Device|Turbohaler (budesonide/formoterol)|Turbohaler® (160 micrograms budesonide/4.5 micrograms formoterol fumarate dihydrate)- Symbicort® 160/4.5. Dose of one inhalation twice a day (mornig and evening) or two inhalations twice a day (morning and evening), for 1 week. Additional 8 weeks in one subgroup
16017469|NCT02757209|Device|Diskus(50mcg salmeterol &250/500 mcg fluticasone propionate)|Diskus® inhaler(50mcg salmeterol&250/500mcg fluticasone propionate)-Seretide Diskus 50/250mcg® or 50/500mcg.Dose of 1inhalation twice a day for1 week.Additional 8 weeks in1subgroup
16017470|NCT02757196|Drug|Rituximab plus methylprednisolone|rituximab （1000mg IV day1, week 3, week 17 , and week 19）
16017471|NCT02757196|Drug|methylprednisolone|1mg/kg, oral or IV; begin to reduce at week 4, reduce 8mg every 2 weeks, then another 8 weeks later reduce 2-4mg every 2-4 weeks
16017472|NCT02757183|Device|"IntelliH"|"IntelliH is a mobile health and a web-based software application that allows patients to enter their blood glucose, weight, medication, diet and other life-style data for review by their providers and monitor their health remotely."
16017473|NCT02757170|Device|Thromboelastography|Patients whole blood will be subjected to undergo coagulation process under monitoring with thromboelastography and various tracings will be recorded and will be interpreted as results.
16017474|NCT02757157|Behavioral|Water-based walking|"Participants will walk in the water for 15 minutes at an intensity rating of five on the modified Borg scale for dyspnoea or perceived exertion, whichever is the highest. Walking intensity will be measured every three minutes during each walking session. If the intensity level is reported as below five, participants will be encouraged to increase the intensity by increasing their walking speed.
~During walking in water, VO2 and VE will be measured breath-by-breath using the Oxycon mobile. Every three minutes during the walking, heart rate, oxygen saturation, dyspnoea and exertion will be measured."
16017475|NCT02757157|Behavioral|Land-based walking|"Participants will walk on land for 15 minutes at an intensity rating of five on the modified Borg scale for dyspnoea or perceived exertion, whichever is the highest. Walking intensity will be measured every three minutes during each walking session. If the intensity level is reported as below five, participants will be encouraged to increase the intensity by increasing their walking speed.
~During walking on land, VO2 and VE will be measured breath-by-breath using the Oxycon mobile. Every three minutes during the walking, heart rate, oxygen saturation, dyspnoea and exertion will be measured."
16017476|NCT02757144|Drug|DWP14012|DWP14012 tablets
16017477|NCT02757144|Drug|Placebo|DWP14012 placebo-matching tablets, Active control placebo-matching tablets
16017478|NCT02757144|Drug|Esomeprazole|Nexium®
16017479|NCT02757131|Other|Ambulation|"Patients randomized to the intervention group will be asked to participate in the ambulation protocol outlined by the PT staff 3 times daily under the supervision of the dedicated ambulator PCNA. This protocol will involve four exercise levels (mobilization, standing, walking, stairs) that may be implemented depending on the current physical capacity of the patient. The cohort of patients randomized to ambulator protocol will also receive the usual care by primary nursing.
~In an effort to best characterize mobility in these patients, the team will collect Braden Scale Activity data from the electronic health record, and provide each patient a mobility tracking device to directly record daily steps taken while the patient is in the hospital. Daily step counts will be collected on a weekly basis from each device. The Braden Scale is entered by nursing on each patient at least daily and measures current activity level on a 4-point scale."
16017480|NCT02757118|Drug|Intravenous Crystalloid|crystalloid is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture
16017481|NCT02757118|Drug|Intravenous HES|HES is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture
16017482|NCT02757105|Drug|BEKINDA|
16017483|NCT02757105|Drug|Placebo|
16017520|NCT02756793|Radiation|Stereotactic Ablative Radiotherapy (SABR)|Patients will receive stereotactic ablative radiotherapy to all sites of progressive disease, with continuation of current systemic agents.
16017484|NCT02757092|Other|Home-based Pulmonary Rehabilitation|(1) breathing exercises (pursed-lip and diaphragmatic breathing) and coughing exercises, (2) aerobic exercises (upper and lower limb exercises and walking), (3) incentive spirometry training (Triflo-II), and (4) threshold load training of the inspiratory muscle. In the first stage (0-2 weeks), the aerobic exercise intensity was targeted to reach 10-11 points on the 20-point Borg rating of perceived exercise (RPE) scale. Patients raised their upper limbs while simultaneously performing lower-limb stepping at place for 20 min; in addition, they walked at a comfortable speed for 15 min twice per day. Incentive spirometry training (Triflo-II) was performed 8-10 times per hour. We used a threshold load trainer for inspiratory muscle training (30 breaths each time, twice per day) with the initial pressure set at 25%-30% of the maximum inspiratory pressure.
16017485|NCT02757079|Drug|NPC-15|NPC-15, Melatonin granule 1 mg, 2 mg or 4 mg, once a day, is administered orally before going to bed for 26 weeks after a screening phase of 2 weeks with placebo administration.
16017486|NCT02757066|Drug|NPC-15 Granules Lower Dose|NPC-15 granule which contains 1mg melatonin
16017487|NCT02757066|Drug|NPC-15 Granules Higher Dose|Melatonin granule which contains 4 mg melatonin
16017488|NCT02757066|Drug|NPC-15 Placebo Granule|Melatonin placebo granule which does not contains melatonin.
16017489|NCT02757053|Device|Guardian Cap|The Guardian Cap is a third party add-on device attached to the facemask of a football helmet that covers the outside of the helmet with a soft material to reduce the initial impact severity, thus reducing the forces transmitted to the brain
16017490|NCT02757040|Drug|Ibrutinib combined with As2O3|arsenic trioxide combined with ibrutinib in CLL
16017491|NCT02757040|Drug|ibrutinib|ibrutinib
16017492|NCT02757027|Drug|Intravenous Crystalloid|crystalloid is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture
16017493|NCT02757027|Drug|Intravenous HES|HES is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture
16017494|NCT02757014|Drug|Coppertone (BAY987517)|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Number - R84-087)
16017495|NCT02757001|Other|Inferior vena cava filter placement and retrieval|"There are really no interventions in this study. This is an prospective observational study of patients that have been implanted a inferior vena cava filter with intention to be retrieved.
~Patients are recruited when the filter is implanted, and the investigators observe when is it finally retrieved, and if there is any complication at the retrieval of the filter."
16017496|NCT02756988|Drug|Coppertone (BAY987704)|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. (Formulation Number: X71-109)
16017497|NCT02756975|Device|coaxial prostate biopsy|In this method, a larger introducing needle is needed for the puncture. The introducing needle is placed over the perineum. The biopsy needle is inserted throughout the introducing needle.Then, the direction of the biopsy is changed by tilting the coaxial needle. The investigator needs to puncture the prostate capsule only once for sampling at each each side of the prostate (right and left sides).
16017498|NCT02756975|Device|noncoaxial prostate biopsy|"In this method, there is no introducing needle. Biopsy needle is inserted repeatedly for each tissue sampling (at least fourteen times). A smaller biopsy needle is used for the puncture in this method.
~The main disadvantage of the coaxial technique is that a larger introducing needle is needed for the puncture (12). On the other whand, the advantage of noncoaxial method is that the needle is within the prostate for only a few seconds to document needle position with ultrasonography before firing"
16017499|NCT02756962|Drug|Cytarabine|
16017500|NCT02756962|Procedure|Allogeneic stem cell transplant|
16017501|NCT02756962|Procedure|Bone marrow aspiration|"Baseline
~Approximately 30 days after cytotoxic induction therapy
~End of treatment"
16017502|NCT02756962|Procedure|Punch skin biopsy|"The first will be obtained with the initial blood and bone marrow collections, whenever possible.
~The second will be obtained at the time of re-biopsy to confirm remission."
16017503|NCT02756962|Device|ClinSeq|Clinical Sequencing to determine clearance or persistence of leukemia-associate mutations performed at MGI CLIA lab
16017504|NCT02756949|Other|Smartphone application|Laboratory result data will be presented in the app with simple explanations on every screen. English and Zulu languages will be offered in the same app and written at a grade 4 reading level (as per WHO guidelines on literacy). Laboratory results will be supplemented with informative and relevant information explaining the result that has been shown and the recommended action for the patient to take. Patients will also be able to view additional HIV-related information and a Frequently Asked Questions (FAQ) through the app.
16017505|NCT02756949|Device|Smartphone|
16017506|NCT02756936|Drug|Daclatasvir Zeta|1 tablet contains 60 mg Daclatasvir
16017507|NCT02756936|Drug|Clatazev|1 tablet contains 60 mg Daclatasvir
16017508|NCT02756910|Device|iThermonitor (WT701)|Continuously monitor the axillary temperature during surgery
16017509|NCT02756897|Drug|Ibrutinib|Given PO
16017510|NCT02756897|Other|Laboratory Biomarker Analysis|Correlative studies
16017511|NCT02756897|Drug|Venetoclax|Given PO
16017512|NCT02756884|Biological|LoFU and aADSC|Administration of low frequency ultrasound prior to administration of autologous adipose derived stem cells.
16017513|NCT02756884|Biological|adipose derived stem cells|control arm will only received the adipose derived stem cells.
16017514|NCT02756871|Other|online guided self-help intervention for perfectionism|"CBT based online guided self-help intervention for perfectionism based on CBT manual for treatment of perfectionism, Cognitive Behavioural Treatment of Perfectionism by Sarah Egan, Tracy Wade, Roz Shafran and Martin Antony"
16017515|NCT02756858|Drug|ANAVEX2-73|
16017516|NCT02756845|Drug|Talimogene Laherparepvec|Talimogene laherparepvec will be administered by intralesional injection only into injectable cutaneous, subcutaneous, nodal tumors, and other non-visceral tumors with or without image ultrasound guidance. The first dose of talimogene laherparepvec will be up to 4.0 mL of 10^6 PFU/mL administered on day 1. The second injection, up to 4.0 mL of 10^8 PFU/mL (or up to 4.0 mL of 10^6 PFU/mL for a dose de-escalated cohort), will be administered 21 (+3) days after the initial injection. All subsequent injections, up to 4.0 mL of 10^8 PFU/mL (or up to 4.0 mL of 10^6 PFU/mL for a dose de-escalated cohort), will be administered every 14 (± 3) days. The treatment cycle interval may be increased due to toxicity.
16017521|NCT02756793|Other|Standard of Care Treatment|"May include:
~Continue with current systemic agent(s)
~Observation
~Switch to next-line treatment
~Palliative radiotherapy is allowed in this arm."
16017522|NCT02756780|Other|Tenovus Cancer Choir|Choir sessions will take place at both of the Royal Marsden Hospital sites on a weekly basis. Sessions typically consist of learning popular songs with messages of support. Songs are learnt without sheet music, using specially created backing tracks. These are also made available to participants at home so they can continue singing away from the sessions. No singing experience is required and the main aim of the sessions is enjoyment and meeting other people. Sessions will take place in the early evening so that participants have the option of staying to socialise afterwards.
16017523|NCT02756767|Other|Survey|
16017524|NCT02756754|Device|Radiofrequency ablation|The radiofrequency system will be used as the RFA generator device standard cycle of ablation will be applied in the patient. During RFA, blood pressure, pulse and oxygen saturation will be continuously monitored.
16017525|NCT02756741|Drug|ALBUMIN|Albumin in two different doses
16017526|NCT02756728|Biological|BI-505|Treatment with BI-505 10 mg/kg bi-weekly infusion, up to 9 doses over 4 months
16017527|NCT02756728|Other|High dose melphalan|High dose melphalan (HDM)
16017528|NCT02756728|Other|Autologous stem cell transplantation|Autologous stem cell transplantation (ASCT)
16017529|NCT02756715|Drug|propofol group|Patient will be anesthetized by using propofol infusion during operation.
16017530|NCT02756715|Drug|Desflurane group|Patient will be anesthetized by using desflurane inhalation during operation.
16017531|NCT02756702|Device|All-Poly|Implantation of the VEGA PS using all-polyethylene tibia components
16017532|NCT02756689|Other|Inpatient cervical ripening|Subjects will undergo cervical ripening in the inpatient setting.
16017533|NCT02756689|Other|Outpatient cervical ripening|Subjects will undergo cervical ripening in the outpatient setting. The patients will then be scheduled to return the next morning for induction of labor.
16017534|NCT02756676|Procedure|Multidisciplinary Intensive Rehabilitation Treatment (MIRT)|MIRT consists of a 4-week physical therapy that entails four daily sessions, five days a week, in a hospital setting. The duration of each session is about one hour. The first session comprise cardiovascular warm-up activities, relaxation, muscle- stretching, exercises to improve the range of motion of spinal, pelvic and scapular joints, exercises to improve the functionality of the abdominal muscles, and postural changes in the supine position. The second session includes aerobic exercises to improve balance and gait using a stabilometric platform, treadmill plus, crossover and cycloergometer. The third is a session of occupational therapy to improve autonomy in daily living activities. The last session includes one hour of speech therapy.
16017535|NCT02756663|Drug|panobinostat (capsules)|Panobinostat capsules, oral: 10mg, 15mg, 20mg dosing 3x a week, 1 week on / 1 week off, in a 4 week cycle (28 days). Treatment arm A: only capsules of 10mg will be used Treatment arm B: capsules of 10mg and 15mg are foreseen for dose reduction only.
16017536|NCT02756663|Drug|carfilzomib (infusion)|Carfilzomib infusion; 20 mg/m2 i.v. on C1D1 and C1D2; 56 mg/m2 i.v. on subsequent dosing days (2x a week; 3 weeks on/1 weeks off ); 4 week cycle (28 days)
16017537|NCT02756663|Drug|dexamethasone (tablets)|Dexamethasone tablets p.o. 20 mg on days of carfilzomib infusion (2x week) and on D22 and D23 of each 4 week cycle (28 days)
16017538|NCT02756650|Drug|Canakinumab|150 mg or 300 mg of canakinumab was administered monthly. IV (SC after month 6)
16017539|NCT02756624|Drug|AC-170 0.24%|
16017540|NCT02756624|Drug|AC-170 Vehicle|
16017541|NCT02756611|Drug|Venetoclax|Tablets for oral administration
16017542|NCT02756598|Drug|Sufentanil I|bolus dose of sufentanil 1 microgram/kg
16017543|NCT02756598|Drug|Sufentanil II|bolus dose of sufentanil 0.5 microgram/kg
16017544|NCT02756598|Drug|Propofol I|Continued dose of propofol 0.03 mg/kg/min
16017545|NCT02756598|Drug|Propofol II|Continued dose of propofol 0.06 mg/kg/min
16017546|NCT02756585|Radiation|ct perfusion|computed tomography perfusion of the head
16017547|NCT02756572|Drug|Cladribine|Given IV
16017548|NCT02756572|Drug|Cyclosporine|Given PO
16017549|NCT02756572|Drug|Cytarabine|Given IV
16017550|NCT02756572|Biological|Filgrastim|Given SC
16017551|NCT02756572|Drug|Fludarabine Phosphate|
16017552|NCT02756572|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic hematopoietic stem cell transplantation
16017553|NCT02756572|Other|Laboratory Biomarker Analysis|Correlative studies
16017554|NCT02756572|Drug|Melphalan|Given IV
16017555|NCT02756572|Drug|Mitoxantrone Hydrochloride|Given IV
16017556|NCT02756572|Drug|Mycophenolate Mofetil|Given PO
16017557|NCT02756572|Other|Questionnaire Administration|Ancillary studies
16017558|NCT02756572|Drug|Sirolimus|Given PO
16017559|NCT02756572|Radiation|Total-Body Irradiation|Undergo TBI
16017560|NCT02756572|Drug|Melphalan Hydrochloride|Given IV
16017561|NCT02756546|Drug|Cyclophosphamide|
16017562|NCT02756546|Drug|Hydroxychloroquine|
16017563|NCT02756546|Drug|Hydrocortisone|
16017564|NCT02756533|Other|Telemonitoring of daily parameters recorded by NIV|"Daily telemonitoring of breathing rate, % of trigger cycles, daily usage of the NIV will go through an algorithm generating alerts when variations will go beyond normal. When an alert is received, a nurse will evaluate the symptoms of the patient by a standardized phone call questionnaire. The results will be transmitted to a referent practitioner who will decide what the patient should do.
~Recommendations will be transferred to the patient within 36 hours."
16017565|NCT02756533|Other|Placebo|Daily telemonitoring of breathing rate, % of trigger cycles, daily usage of the NIV will go through an algorithm generating alerts when variations will go beyond normal. Alerts will only be collected, the patient will not be contacted by phone during the alert.
16017566|NCT02756520|Other|Observational study: Supplemented protein-restricted diet|Observational study: Supplemented protein-restricted diet
16017567|NCT02756507|Behavioral|video-based transdiagnostic REBT|The video-based transdiagnostic REBT consists of 6 sessions delivered in a group format.
16017568|NCT02756507|Behavioral|Wait list|Delayed intervention
16017569|NCT02756494|Biological|Ischemic Stroke|Ischemic Stroke in Chinese Young Adults
16017696|NCT02755402|Device|Xpert HCV Viral load|HCV viral load testing
16017570|NCT02756468|Other|pts operated for pancreatic cancer|measuring CRP and PCT in 3rd and 5th POD after pancreatic cancer resection
16017571|NCT02756455|Other|gastric cancer pts undergoing surgery|Measure PCT (procalcitonin), CRP (C-reactive protein) and WBC (white blood cell count) in 3rd and 5th postoperative day and registration of all intra and postoperative complications
16017572|NCT02756442|Other|Respiratory disorder assessment during sleep|
16017573|NCT02756429|Other|blood samples|Patients with atrial fibrillation for whom electrophysiology exploration or ablation are programmed; All blood samples will be taken through the exploration catheter. For the peripheral blood sample, blood will be taken at the introduction of the catheter into the femoral vein. Then the blood samples in the coronary sinus and in the left atrium will be made at progressively exploration.
16017574|NCT02756416|Device|MRI brain|Standard MRI brain will be performed on each participant to look at brain structure and exclude complications of RCVS (if any).
16017575|NCT02756416|Device|ASL-MRI brain|ASL-MRI is a non-contrast scan used to measure cortical cerebral blood flow (CBF) in areas supplied by major arteries (Circle of Willis).
16017576|NCT02756416|Device|MRA brain|MR angiography scan looks at blood vessels structure. We expect to see constriction (narrowing) of the major arteries in RCVS cases.
16017577|NCT02756403|Drug|Azithromycin|500 mg
16017578|NCT02756403|Drug|Doxycycline|200 mg
16017579|NCT02756403|Drug|Metronidazole|500 mg
16017580|NCT02756403|Drug|Placebo|Placebo pills will be given before the uterine aspiration. Antibiotics will be given after the uterine aspiration.
16017581|NCT02756390|Behavioral|CBTI-CS|CBTI-CS is a multi-modal intervention designed to address both cognitive and behavioral factors that perpetuate insomnia. Cognitive factors are addressed via cognitive restructuring and psychoeducation. Behavioral factors are addressed by structured sleep restriction, stimulus control and sleep hygiene techniques. Cancer treatment late-effects affecting sleep are addressed as potential contributors to these cognitive and behavioral factors, and as symptoms that may benefit from referral for medical evaluation/management. Participants are instructed in these cognitive-behavioral strategies as a group, but using analysis of personal sleep-log data, symptom self-reports and targeted workbook exercises, they are helped to tailor the intervention to address their specific needs.
16017582|NCT02756390|Behavioral|Sleep Hygiene|Education on health behaviors, sleep habits and environmental practices intended to promote good quality sleep. Recommendations target exercise and natural light exposure,use of stimulants and alcohol, daytime napping, timing of meals, creating a comfortable non-stimulating sleep space, and creating sleep rituals.
16017583|NCT02756390|Behavioral|CBTI-CS via Telehealth|The CBTI-CS intervention, a multi-modal intervention designed to address both cognitive and behavioral factors that perpetuate insomnia, will be administered via live video. conferencing. Participants will have a single in-person training session and subsequent CBTI-CS group sessions will be conducted by live video conference.
16017584|NCT02756377|Drug|cetylpyridinium chloride mouthwash|cetylpyridinium chloride mouthwash, 10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.
16017585|NCT02756377|Drug|Chlorhexidine mouthwash|Chlorhexidine mouthwash,10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.
16017586|NCT02756364|Drug|Fulvestrant|Fulvestrant IM injection.
16017587|NCT02756364|Drug|Sapanisertib|Sapanisertib capsule.
16017588|NCT02756351|Device|CytaCoat Nasal Prong|
16017589|NCT02756351|Device|Inspiration Healthcare Inspire nCPAP Nasal Prong|
16017590|NCT02756338|Device|BioMonitor 2 Insertable Cardiac Monitor|
16017591|NCT02756325|Device|MRI|Imaging will be performed using a clinical whole-body MRI and a pelvic phased-array coil. No intravenous contrast will be administered. Sequences will include Diffusion weighted imaging (DWI), T2 mapping, arterial spin labeling, and spectroscopy. The acquisition is expected to take approximately one hour
16017592|NCT02756312|Other|IV Anesthesia|The patients will receive intravenous anesthesia
16017593|NCT02756312|Other|IH anesthesia|The patients will receive inhalation anesthesia
16017594|NCT02756299|Other|Educational Support|General information about OSA and PAP treatment at baseline and additional polysomnography chart viewing from both diagnostic and titration nights
16017595|NCT02756299|Other|Standard Support|General information about OSA and PAP treatment at baseline
16017596|NCT02756286|Other|NAT electroencephalography (EEG) test|Individuals in both groups are asked to perform standard behavioral tests and an electroencephalography (EEG) test.
16017597|NCT02756273|Device|bridge device|
16017598|NCT02756273|Device|no bridge device|
16017599|NCT02756247|Drug|Buparlisib|
16017600|NCT02756247|Drug|Ibrutinib|
16017601|NCT02756221|Dietary Supplement|Probiotics|One capsule per day for 90 days. Containing 8 x 109 CFU of bacteria /capsule Lactobacillus heleveticus Lafti L10 Bifidobacterium animalis ssp lactis Lafti B94 Enterococcus faecium Rosell-26 Bifidobacterium longum RO175 Bacillus subtills Rosell-179 Inactive ingredients: potato starch, magnesium stearate, ascorbic acid White vegetable capsule size 1
16017602|NCT02756221|Other|Placebo|Placebo capsules identical in shape and color to the probiotics capsules, one capsule per day for 90 days
16017603|NCT02756208|Biological|0.25 mL FLSC Vaccine Group|FLSC vaccine 75 mcg (0.25 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168
16017604|NCT02756208|Biological|0.25 mL Placebo Group|Placebo saline 0.25 mL given by intramuscular injection into the arm on study Days 0, 28, 56, 168
16017605|NCT02756208|Biological|0.5 mL FLSC Vaccine Group|FLSC vaccine 150 mcg (0.5 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168
16017606|NCT02756208|Biological|0.5 mL Placebo Group|Placebo sterile saline 0.5 mL given by intramuscular injection into the arm on study Days 0, 28, 56, 168
16017607|NCT02756208|Biological|1.0 mL FLSC Vaccine Group|FLSC vaccine 300 mcg (1.0 mL) given by intramuscular injection into the arm on study Days 0, 28, 56, 168
16017608|NCT02756208|Biological|1.0 mL Placebo Group|Placebo sterile saline 1.0 mL given by intramuscular injection into the arm on study Days 0, 28, 56, 168
16017609|NCT02756182|Device|TDOC air-charged catheter|Urodynamic study utilizing a single catheter technique to measure WP & AC measurements
16017610|NCT02756169|Other|Intervention|Three actions since pregnancy until the first year of life of the baby for helping the women with obesity to increase the probability of a successful breastfeeding.
16018078|NCT02752854|Other|pain threshold measurement|pressure algometer
16017611|NCT02756143|Behavioral|Exercise|"Supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training.
~Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60% of heart rate reserve. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate."
16017612|NCT02756130|Drug|Birinapant|Given IV
16017613|NCT02756130|Drug|Carboplatin|Given IV
16017614|NCT02756130|Other|Laboratory Biomarker Analysis|Correlative studies
16017615|NCT02756130|Other|Pharmacological Study|Correlative studies
16017616|NCT02756117|Drug|L-Lysine|
16017617|NCT02756117|Drug|Normal (0.9%) Saline|
16017618|NCT02756104|Other|phenotyping Tcells|Collecting blood for analyses of the T cells phenotypes
16017619|NCT02756104|Other|Supplementation in vitamin D|Supplementation in vitamin D for the patients who are deficient on vitamin D
16017620|NCT02756091|Other|No study-specific intervention|
16017621|NCT02756078|Device|TEST Contact Lens|
16017622|NCT02756078|Device|CONTROL Contact Lens|
16017623|NCT02756065|Other|no intervention|no intervention is used
16017624|NCT02756052|Device|Anodal Transcranial direct-current stimulation|NeuroConn Direct-Current Stimulator. Anodal tDCS: 45 second ramp up to 1milliamp, 20 minute current hold at 1milliamp, 45 second ramp down to 0milliamp. Anode positioned 2cm posterior to the left primary motor cortex, and the cathode over the contralateral supraorbital area.
16017625|NCT02756052|Device|Sham Transcranial direct-current stimulation|NeuroConn Direct-Current Stimulator. Sham tDCS: 45 second ramp up to 1milliamp, 60 second current hold at 1milliamp, 45 second ramp down to 0milliamp. Anode positioned 2cm posterior to the left primary motor cortex, and the cathode over the contralateral supraorbital area.
16017626|NCT02756026|Dietary Supplement|Multiple micronutrient supplement (Nutri-Fem)|Multiple micronutrient supplement (Nutri-Fem) manufactured by Thorne, containing the Recommended Dietary Intake (RDA).
16017627|NCT02756013|Drug|Paclitaxel|80mg/m2 IV days 1,8, and 15 every 21 days x 6-9 cycles
16017628|NCT02756013|Drug|Carboplatin|area under the curve (AUC) 6 IV day 1 every 21 days x 6-9 cycles
16017629|NCT02756000|Procedure|PCI|percutaneous angioplasty and stent implantation in coronary artery with significant atherosclerosis and stenosis
16017630|NCT02756000|Procedure|dobutamine stress echocardiography|Echocardiographic stress test of provoked myocardial ischemia using dobutamine
16017631|NCT02755987|Drug|ANG1005|
16017632|NCT02755961|Behavioral|Dietary education|
16017633|NCT02755961|Behavioral|Education on phosphate binder use|
16017634|NCT02755948|Biological|RSV A Memphis 37|Good Manufacturing Practices-certified RSV Memphis 37 10(4) PFU in 1 mL 25% sucrose/DMEM delivered by intranasal drops
16017635|NCT02755948|Biological|Influenza A/California/04/2009|Good Manufacturing Practices-certified Influenza A/California/04/09 3.5x10(4) TCID50 in 1 mL in DPBS delivered by intranasal drops
16017636|NCT02755935|Device|Cochlear Nucleus CI532|cochlear implantation
16017637|NCT02755922|Biological|Application of autologous mesenchymal stem cells|within the surgical procedure, mesenchymal stem cells, were applied on the fracture site. Imaging by X-ray and CT and imaging analysis was done after fracture repair, at week 4 and week 12
16017638|NCT02755909|Behavioral|Pre-anesthetic Education|Education was done before the anesthetic procedure, using a flip chart made by the researchers.
16017639|NCT02755896|Radiation|Arm 1 600 cGY x 5 fractions|Patients who are randomized to Arm 1 will receive either 600 cGY x 5 fractions over 5 consecutive days
16017640|NCT02755896|Radiation|Arm 2 800 cGY x 3 fractions|Patients who are randomized to Arm 2 will receive 800 cGY x 3 fractions given every other day
16017641|NCT02755883|Behavioral|Physical activity plus positive affect|Subjects will be randomized to a physical activity goal and will receive the positive affect component.
16017642|NCT02755883|Behavioral|Physical activity plus education|Subjects will be randomized to a physical activity goal and will receive the educational component.
16017643|NCT02755870|Other|CNM-Au8|Clene's technology integrates nanotechnology, materials science, plasma conditioning (corona discharge), and hydro-electrocrystallization to create a new nanocatalytic drug class
16017644|NCT02755870|Other|Placebo|Placebo oral suspension which matches the volume of the experimental nanocrystal suspension
16017645|NCT02755857|Drug|Lozanoc|65 mg
16017646|NCT02755844|Drug|Olaparib|"Olaparib tablet dose will be dose-escalated on 4 dose levels , guided by a continual reassessment method (CRM).
~One cycle will be 28 days (4 weeks) in duration, except for cycle 1 which will be 6 weeks."
16017647|NCT02755844|Drug|metformin|From week 3 metformin will be gradually escalated from 500 mg/day to 1500 mg/day with weekly 500 mg dose escalation levels
16017648|NCT02755844|Drug|metronomic cyclophosphamide|from week 2 Metronomic cyclophosphamide will be given continuously on an oral daily basis at 50 mg qd
16017649|NCT02755831|Device|CPAP|Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea
16017650|NCT02755831|Other|Pre-natal care|Standard Pre-Natal Care
16017651|NCT02755818|Drug|Heparin|This is not an interventional study. The investigators use heparin at 50unit/kg of body weight to release enzyme lipoprotein lipase (LPL) from the body. LPL level will be used as part of calculation of lipid analysis and measurements
16017652|NCT02755805|Behavioral|CO-OP|
16017653|NCT02755805|Behavioral|Attention Control|
16017654|NCT02755792|Behavioral|Calligraphy Training|
16017655|NCT02755792|Behavioral|iPad Training|
16017656|NCT02755753|Drug|Lansoprazole|Oral administration of Lanston® (lansoprazole) 30 mg, 1 capsule, PO, qd, 30 min before breakfast
16017657|NCT02755753|Drug|Rebamipide|Oral administration of Mucosta (rebamipide) 100 mg, 1 tablet, PO, tid, 30 minutes before breakfast, lunch, and dinner
16017658|NCT02755753|Drug|Rebamipide-placebo|Oral administration of Mucosta®-placebo, 1 tablet, PO, tid, 30 minutes before breakfast, lunch and dinner
16017697|NCT02755402|Device|Transient elastography|Evaluation of liver fibrosis
16017801|NCT02754726|Drug|Paricalcitol|25 micrograms IV on days 1,4,8,12,15,18,22,26,29,32,36,39 (+/-1 day allowed for dosing per 42 day cycle
16017872|NCT02754258|Drug|Placebo|60 days on oral placebo administered 2 times daily before lunch and supper
16017659|NCT02755740|Other|receiving age and gender-specific SC advice|"After delivering the AWARD advice, the trained SCRA will seek consent from and refer adult female smokers (aged over 25 years) to our intensive smoking cessation telephone or face-to-face counselling interventions, which has already counselled 509 female smokers with a quit rate of 29.7% at 6-month and 26.7% at 3-year follow up. Female youth smokers will give consent and be referred to our Youth Quitline (5111 4333), a smoking cessation telephone counselling for young people aged 25 or below which has counselled 1257 smokers with a quit rate of 21.9% at 6 months. If necessary, the female smokers can be referred to other smoking cessation services (e.g., the integrated smoking cessation hotline by the Department of Health (1833-183)."
16017660|NCT02755727|Procedure|Platelet Rich Plasma Injection|See Arms
16017661|NCT02755727|Procedure|Open Surgical Release|See arms
16017662|NCT02755714|Drug|Ipratropium bromide spray|The patient will - or will not - receive Ipratropium bromide spray (MDI) 20 μg given through a plastic spacer two puffs 1 hour before a continuous laryngoscopy exercise test (CLE-test)
16017663|NCT02755701|Drug|Branched-chain Amino Acid|BCAA (livact) will be administered 3 times a day during 24 weeks
16017664|NCT02755701|Drug|Placebo|Placebo will be administered in the same way
16017665|NCT02755688|Procedure|Thoracoscopic Surgical ablation|Thoracoscopic approach to isolate pulmonary veins, ganglionic plexi ablation and left atrial appendage exclusion
16017666|NCT02755688|Procedure|Catheter ablation|Ablation using contact force technology to isolate pulmonary veins and create linear lesions.
16017667|NCT02755675|Other|68Ga-NOTA-AE105 PET/CT|Following injection of 68Ga-NOTA-AE105 the patients will be subjected to PET/CT
16017668|NCT02755662|Device|Mandibular Retention Device|
16017669|NCT02755649|Drug|Dupilumab|
16017670|NCT02755649|Drug|Matching Placebo|
16017671|NCT02755636|Behavioral|PCPHC|Mobile-delivered health risk intervention (HRI), computer-tailored interventions (CTIs), text messages; provider-delivered one-on-one session guided by clinical dashboard
16017672|NCT02755636|Other|Usual care|Primary care as usual
16017673|NCT02755623|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|Participants are sequentially randomly assigned to either 20 active rTMS sessions or 20 sham rTMS sessions that were applied over the left temporoparietal junction. Treatments are administered daily, over a period of two weeks.
16017674|NCT02755623|Device|Sham Repetitive Transcranial Magnetic Stimulation (rTMS)|
16017675|NCT02755610|Other|PD Product Check List|PD Product Check List was developed based on the 28 routine steps of standard orientation manual for new Thai PD patients. Of these, step 2 (weighting the PD solution bag), step 3 (checking expiration date, volume, glucose concentration, clarity, and color, step 27 (weighting the PD solution bag), and step 28 (recording time, volume, and any abnormality encountered) are relevant to product defect report.
16017676|NCT02755597|Drug|Placebo|Tablet
16017677|NCT02755597|Drug|Bortezomib|Solution for subcutaneous injection
16017678|NCT02755597|Drug|Dexamethasone|Tablet
16017679|NCT02755597|Drug|Venetoclax|Tablet
16017680|NCT02755558|Behavioral|Low energy density|Low energy density milk served
16017681|NCT02755558|Behavioral|High energy density|High energy density milk served
16017682|NCT02755558|Behavioral|Small portion|Small portion of milk served
16017683|NCT02755558|Behavioral|Large portion|Large portion of milk served
16017684|NCT02755545|Drug|Product A (adapalene)|Product A applied topically to the entire face or other affected area of the skin once daily
16017685|NCT02755545|Drug|Product B (salicylic acid)|Product B applied topically to affected area of the skin 1 to 3 times daily
16017686|NCT02755532|Drug|Bupivacaine 0,25%|Venous blood samples were collected prior to blocking , every 15 min during the first hour after completion of the blocking and every 30 min during the second hour after completion using an exclusive cannula. Then, 5 ml was drawn off and was stored in two EDTA tubes (BD, Franklin Lakes, NJ, USA). The EDTA tubes were centrifuged at 3,500xg for 10 min to obtain the blood plasma. This plasma was then stored in cryogenic tubes in a freezer at -80 °C until the time of the analysis. A high-performance liquid chromatography apparatus (Shimadzu, Kyoto, Japan) coupled to a Bruker mass spectrometer (MS), model Amazon (USA), with electrospray source ionization and a sequential mass spectrometry system (MS/MS) were used for the analysis. After obtaining the precursor ion, a fragment was obtained via a collision-induced dissociation process. The following molecular ions were selected: 289.0 m/z==>140.1 m/z. The methodology was validated according to the international FDA recommendations.
16017687|NCT02755532|Drug|Bupivacaine 0,5%|Venous blood samples were collected prior to blocking , every 15 min during the first hour after completion of the blocking and every 30 min during the second hour after completion using an exclusive cannula. Then, 5 ml was drawn off and was stored in two EDTA tubes (BD, Franklin Lakes, NJ, USA). The EDTA tubes were centrifuged at 3,500xg for 10 min to obtain the blood plasma. This plasma was then stored in cryogenic tubes in a freezer at -80 °C until the time of the analysis. A high-performance liquid chromatography apparatus (Shimadzu, Kyoto, Japan) coupled to a Bruker mass spectrometer (MS), model Amazon (USA), with electrospray source ionization and a sequential mass spectrometry system (MS/MS) were used for the analysis. After obtaining the precursor ion, a fragment was obtained via a collision-induced dissociation process. The following molecular ions were selected: 289.0 m/z==>140.1 m/z. The methodology was validated according to the international FDA recommendations.
16017688|NCT02755506|Device|endobronchial ultrasound elastography|Before endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA), patients will undergo the examination of endobronchial ultrasound elastography
16017689|NCT02755493|Behavioral|Sleep deprivation|
16017690|NCT02755480|Device|Ultralow Dose Thoracic Computed Tomography|Ultralow dose chest CT (uLDCTT) at a radiation dose comparable to 2 chest X-rays
16017691|NCT02755467|Device|KTP laser|Dual Wavelength Laser Emitting 532 nm Laser Energy
16017692|NCT02755454|Device|Perfusion CT Imaging|
16017693|NCT02755428|Biological|retinal pigment epithelium transplantation|Transplant retinal pigment epithelium derived from human embryonic stem cells into subretinal space of patients with dry age-related macular degeneration(dry AMD).
16017694|NCT02755415|Device|HIWIN Robotic Gait Training System|HIWIN Robotic Gait Training System is an automatic training system that combines weight-bearing standing, repetitive stepping and gait training
16017695|NCT02755415|Other|Static Standing Table|As part of the standard hospital rehabilitation, static standing table allows patient to be in a fully supported standing position
16017698|NCT02755389|Drug|0 L/min oxygen via conventional nasal cannulae|Patients will have conventional nasal cannulae placed under chin prior to induction of anesthesia. Immediately post-induction these will be placed into the nares. They will be removed from the nares at the end of the study when the airway has been secured. There will be no oxygen flowing through the cannulae in this group during the study.
16017699|NCT02755389|Drug|15 L/min oxygen via conventional nasal cannulae|Patients will have conventional nasal cannulae placed under chin prior to induction of anesthesia. Immediately post-induction these will be placed into the nares. They will be removed from the nares at the end of the study when the airway has been secured. There will be 15 L/min of oxygen flowing through the cannulae in this group during the study.
16017700|NCT02755389|Drug|60 L/min oxygen via high-flow nasal cannulae|Patients will have high-flow nasal cannulae placed under chin prior to induction of anesthesia. Immediately post-induction these will be placed into the nares. They will be removed from the nares at the end of the study when the airway has been secured. There will be 60 L/min of oxygen flowing through the cannulae in this group during the study.
16017701|NCT02755376|Biological|Cartistem(TM)|ACL reconstruction and injection of Cartstem(TM), human cord blood derived mesenchymal stem cell under arthroscopy.
16017702|NCT02755376|Biological|hyaluronic acid|ACL reconstruction and injection of hyaluronic acid under arthroscopy.
16017703|NCT02755376|Procedure|ACL reconstruction only|ACL reconstruction only without any injection under arthroscopy
16017704|NCT02755363|Other|osteopathic manual therapy|"suboccipital decompression - atlanto-occipital joint relaxation technique.
~deep cervical fascia release - the technique aims to improve mobility of the first and second ribs during expiration and to relaxation of the vagus and phrenic nerve course area.
~thoracic lymphatic pump with activation is designed to reduce the tension of mediastinal structures, improve lymphatic flow, and thus reduce the breathing resistance.
~stretching the diaphragm in order to relax and reduce adhesion within the fascial system between the diaphragm and abdominal organs."
16017705|NCT02755363|Other|control group|"manual mobilization techniques of the slides in the shoulder joint toward the front, rear and bottom.
~manual techniques to increase range of motion in the shoulder joints using the patient's breathing manoeuvres."
16017706|NCT02755350|Drug|Truvada|Daily oral PrEP will be provided to a cohort of 2100 participants (female sex workers, men who have sex with men and young women at high HIV risk) in Kenya. Baseline data will be collected from all participants at enrolment. PrEP users will be followed up at multiple intervals, in months 1, 4, 7, 10 and 12) for 12 months. The PrEP users will attend 7 visits at the project sites over the project period and in between these visits, they will return to the pharmacy for PrEP refill, adherence counselling and assessment of side effects.
16017707|NCT02755324|Biological|male Schistosoma mansoni cercariae|Viable male Schistosoma mansoni cercariae of the Puerto Rican strain
16017708|NCT02755311|Procedure|liver resection|Intraoperative ultrasound was routinely used during surgery. Anatomic resection was carried out in the form of segmentectomy or/and subsegmentectomy.In segmentectomy, the hepatic parenchyma was transacted at the intersegmental plane as described by Couinaud. If the hepatic parenchymal transaction plane needed to go beyond the intersegmental plane to achieve the desired extent of resection margin, the small portal branches supplying the liver parenchyma up to the intended transaction plane were punctured under US guidance and injected with methylthioninium chloride, and then liver subsegmentectomy was performed either alone or in combination with segmentectomy along the plane of demarcation as delineated by the injected methylthioninium chloride. Nonanatomic resection with a negative resection margin was performed when anatomical resection may cause inadequate liver remnant. Pringle's maneuver was used if necessary with a clamp/unclamp time of 10 min/5 min.
16017709|NCT02755311|Procedure|transarterial chemoembolization|A microcatheter was inserted into the feeding arteries as selectively as possible through the lobar, segmental, or subsegmental arteries, dependent on the tumor distribution and hepatic functional reserve. Hepatic artery infusion chemotherapy was performed using 300 mg carboplatin. Subsequently, chemolipiodolization was performed mixed with 5 ml of lipiodol. According to the number and size of the lesions, and liver and kidney function of the patient, the chemotherapeutic agents, including epirubicin (50-100 mg), pirarubicin (30-50 mg), hydroxycamptothecin (10-30 mg) and fluorouracil (500-1000 mg), were determined by the multidisciplinary team. If residual flow remained after infusion of these agents, additional lipiodol was injected. Embolization was performed with absorbable gelatin sponge particles 350-560 μm in diameter.
16017710|NCT02755311|Drug|carboplatin|Hepatic artery infusion chemotherapy was performed using 300 mg carboplatin (Bristol-Myers Squibb, New York, NY).
16017711|NCT02755311|Drug|lipiodol|Chemolipiodolization was performed mixed with 5 ml of lipiodol (Lipiodol Ultra-Fluide; André Guerbet Laboratories, Aulnay-sous-Bois, France).
16017712|NCT02755311|Drug|epirubicin , pirarubicin , hydroxycamptothecin and fluorouracil|The chemotherapeutic agents, including epirubicin (50-100 mg), pirarubicin (30-50 mg), hydroxycamptothecin (10-30 mg) and fluorouracil (500-1000 mg), were determined by the multidisciplinary team.
16017713|NCT02755311|Other|absorbable gelatin sponge particles|Embolization was performed with absorbable gelatin sponge particles (Gelfoam; Hangzhou Bi-Trumed Biotech Co., Ltd., Hangzhou, Zhejiang, China) 350-560 μm in diameter.
16017714|NCT02755298|Drug|Acetazolamide|
16017715|NCT02755298|Drug|Placebo|
16017716|NCT02755285|Device|Single Endoscopy Procedure|All subjects will have 1 endoscopy procedure, in which they will have a white light examination followed by FICE and BLI imaging on a maximum of two (2) anatomical sites per subject.
16017717|NCT02755272|Drug|Pembrolizumab|IV Infusion of 200 mg given on day one of each 21 day treatment cycle.
16017718|NCT02755272|Drug|Carboplatin|IV infusion of a calculated dose (AUC 2 mL/min) given on days one and eight of each 21 day treatment cycle.
16017719|NCT02755272|Drug|Gemcitabine|IV infusion of 800 mg/m^2 given on days one and eight of each 21 day treatment cycle.
16017720|NCT02755259|Drug|Acetazolamide|
16017721|NCT02755259|Drug|Placebo|
16017722|NCT02755246|Dietary Supplement|Polyamine supplementation|3 months of polyamine supplementation (3 capsules/day)
16017723|NCT02755246|Dietary Supplement|Placebo supplementation|3 months of placebo intake (3 capsules/day)
16017799|NCT02754726|Drug|Nivolumab|Nivolumab 240mg 240 mg as a 60 minute infusion on days 1, 15, 29 per 42 day cycle
16017800|NCT02754726|Drug|Albumin-bound paclitaxel|125 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
16019527|NCT02741765|Behavioral|Supervised aerobic exercise|
16017724|NCT02755233|Other|Pulmonary Function|Spirometry and DLCO were measured according to performance standards based on the statements from the American Thoracic Society (ATS) and the European Respiratory Society (ERS). Values of DLCO were adjusted for the patient's current hemoglobin value, and the patients were asked to withhold cigarette smoking at least four hours before pulmonary function testing. Lung volumes and DLCO were measured with a commercial ZAN300 CO Diffusion system (nSpire Health GmbH, Oberthulba, Germany)
16017725|NCT02755220|Device|Cingularbio® Aortic valve replacement|the patients will be replaced by Cingularbio heart valve
16017726|NCT02755194|Other|No intervention|This is an observational study. The exposure of interest includes taking specific prescribed medications during breastfeeding.
16017727|NCT02755181|Behavioral|Experimental|with functional imaging and behavioural measurements at baseline and 4 weeks
16017728|NCT02755168|Procedure|External Pop-Out Cesarean Section|During fetal head extraction, the obstetrician puts four fingers of his right hand on the lower segment at uterovesical pouch. The palmar aspect of the fingers will be resting on the uterovesical peritoneal reflection not on directly on the fetal head. While the palmar aspect of the fingers was facing the lower segment they were pushed deep below the fetal head.
16017729|NCT02755168|Procedure|Classic technique|During fetal head extraction, the obstetrician puts four fingers of his right hand inside the uterus.
16017730|NCT02755155|Drug|Human serum albumin infusion 4%|Continuous infusion of 15mL/kg of bodyweight over 24h/day
16017731|NCT02755155|Drug|Human serum albumin infusion 20%|Specify details not covered in associated Arm Description. Intermittent infusion up to 200 ml/8h/day until the plasma albumin concentration is in the range 30+3g/L
16017732|NCT02755142|Biological|Gliolan|
16017733|NCT02755129|Other|Walking Exercises-Six Minute Walk (6MW) Test|The Six Minute Walk (6MW) Test measures the distance an individual is able to walk over a total of six minutes on a flat surface. The goal is for the individual to walk as far as possible in six minutes. The Six Minute Walk (6MW) test will be performed within the Computer Assisted Rehabilitation Environment (CAREN) system system environment - single arm
16017734|NCT02755129|Other|Walking Exercises-4 Meter Gait Speed (4MGS) Test|"The 4 Meter Gait Speed (4MGS) Test measures the gait speed an individual is able to walk over 4 meters on a flat surface. The goal is for the individual to walk as fast as possible over 4 meters.
~It will be repeated 3 times within the aforementioned 6MW test (after approximately 1, 3 and 5 minutes) to get variability due to subject tiredness. The test will be performed within the CAREN system environment. - single arm"
16017735|NCT02755129|Other|Walking Exercises-Five Times Sit to Stand (FTSTS) Test|The Five Times Sit to Stand (FTSTS) Test measures the time a subject takes to stand up from an armchair 5 times in a row, without stopping in between. It is a short test which measures dynamic balance and functional mobility - single arm
16017736|NCT02755129|Other|Walking Exercises-Expanded Timed Get-Up-and-Go (ETGUG) Test|The Expanded Timed Get-Up-and-Go (ETGUG) Test measures the time it takes a subject to stand up from an armchair, walk a distance of 10 m, turn, walk back to the chair, and sit down. It is a short test of basic mobility skills for frail community-dwelling elderly. - single arm
16017737|NCT02755129|Other|Reveal LINQ accelerometer|Walking exercises test
16017738|NCT02755129|Other|3D accelerometer|Walking exercises test
16017739|NCT02755116|Drug|Olanzapine|10mg of olanzapine by mouth prior to anesthetic induction
16017740|NCT02755116|Drug|Placebo|placebo by mouth prior to anesthetic induction
16017741|NCT02755103|Behavioral|Mindfulness Based Relapse Prevention (MBRP)|MBRP integrates coping skills from cognitive-behavioral relapse prevention therapy with Mindfulness Meditation (MM) practices, raising awareness of substance use triggers and reactive behavioral patterns, and teaching skillful coping responses.
16017742|NCT02755090|Drug|Nitrous Oxide|Participants in the nitrous oxide group will receive a scented face mask through which nitrous oxide will be administered. The nitrous content of the gas will be titrated up by 20% every 5 breaths with a goal of 70% N2O/ 30% O2 as tolerated by the participant. This group will also receive saline through an IV. All participants will receive local anesthesia in the form of a paracervical block and ibuprofen pre-operatively.
16017743|NCT02755090|Drug|IV Saline|
16017744|NCT02755077|Procedure|Head rotation during mask ventilation|Patient's head position is axially rotated 45 degrees to the right.
16017745|NCT02755064|Drug|Erythromycin lactobionate|In Phase 1 of the study, during the second visit, erythromycin was given as an initial bolus of 0.5 mg/kg over 10 min immediately before the meal. Thereafter, an infusion of 1.5 or 2.5 mg/kg was given over the next 50 min with the same infusion pump. The goal of testing 2 different doses was not to assess dose-related effects but to compare glycemic indices against a spectrum of gastric emptying rates.
16017746|NCT02755064|Drug|Placebo IV|In Phase 1 of the study, during the second visit, saline was given as an initial bolus over 10 min immediately before the meal. Thereafter, an infusion of saline was given over the next 50 min with the same infusion pump.
16017747|NCT02755064|Drug|[13C]-Spirulina|The subject consumed the test meal containing 13C-Spirulina in no more than 10 minutes. Breath samples were collected at baseline obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points.
16017748|NCT02755064|Drug|Erythromycin Ethylsuccinate Suspension|In Phase 2 of the study, subjects randomized to this arm will receive Erythromycin Ethylsuccinate Suspension 250 mg tid orally for a total period of 7 days.
16017749|NCT02755064|Drug|Placebo Suspension|In Phase 2 of the study, subjects randomized to this arm will receive an oral placebo prepared to mimic the Erythromycin Ethylsuccinate Suspension for a total period of 7 days.
16017750|NCT02755051|Behavioral|Cognitive Behavioral Therapy|"Cognitive Behavioral Therapy for children with Chronic Insomnia and Autism Spectrum Disorder involves 8, one-hour sessions of a non-drug cognitive behavioral intervention. Session content listed below:
~Sleep education
~Sleep scheduling, limit setting, and stimulus control
~Teaching relaxation strategies and other adaptive coping skills
~Parenting strategies (differential attention, rewards, consequences)
~Identification of maladaptive & adaptive cognitions
~Problem solving & communication skills
~Sleep restriction; bright light to change circadian rhythms
~Review gains and plan for long-term maintenance"
16017751|NCT02755025|Other|Automated SOFA scoring calculator|Automated SOFA scoring will be activated within an existing electronic patient care dashboard for ICU patients.
16017752|NCT02754999|Drug|SANGUINATE™|As needed (PRN) infusions of 500 mL of SANGUINATE
16017753|NCT02754986|Other|Analysis of the holter electrocardiogram|
16088072|NCT02251132|Drug|TPV high 2|
16017754|NCT02754973|Behavioral|an integrated experiential training program with coaching|The intervention will be implemented to each participant by a designated coach who is a trained nursing student during 28 home visits throughout a 6-month period (24 weeks) and each visit will last for about 1 hour. The 1-hour program consists of a 30-minute English tutorial session, and a 30-minute physical activity session with the coach. The same coach will pay a visit to a participant at twice a week for the first 4 weeks and then once a week for the subsequent 20 weeks. 4 levels of physical activity will be taught to the participants gradually according to their ability.
16017755|NCT02754973|Behavioral|Placebo Control|When discharged home, participants will receive an amount of time and attention (home visits by research assistants) that mimicked that received by the experimental group, but which is thought not to have any specific effect on the outcome measures. The placebo activities during the home visits may include playing cards or chess games, health advice on the prevention of influenza and healthy diet which will be conducted for 30 minutes.The participants will also receive a 30-minute English tutorial session with the research assistants in each home visit.
16017756|NCT02754960|Drug|Thalidomide|Interventions administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 1 time daily at 10 p.m)
16017757|NCT02754960|Drug|Placebo|Placebo administered (dosage, 100mg; dosage form, 25mg; frequency of administration, 1 time daily at 10 p.m)
16017758|NCT02754934|Other|Cervical range of motion|Patients will fill out the Neck Disability Index, Visual Analogue Pain Rating Scale and the Self-administered Neck range of motion questionnaire.
16017759|NCT02754921|Procedure|percutaneous dilatational tracheostomy using Ultra-Perc|Procedure difficulties and complications faced while doing percutaneous dilatational tracheostomy using Ultra-Perc
16017760|NCT02754921|Procedure|Percutaneous dilatational tracheostomy using Ciaglia Blue Dolphin|Procedure difficulties and complications faced while doing percutaneous dilatational tracheostomy using Ciaglia Blue Dolphin
16017761|NCT02754908|Behavioral|musical training|The subjects in the experimental group will receive weekly 45-minute lessons on musical training for one year (52 weeks), conducted by the Music Children Foundation.
16017762|NCT02754908|Behavioral|tutoring classes|They will be invited to attend free, weekly 45-minute tutoring classes organised by the community for one year (52 weeks).
16017763|NCT02754895|Other|Positive Psychology (PP)|Positive psychology (PP) interventions aim to improve the frequency and intensity of positive emotional experiences. This positive psychology intervention focuses on targeted activities in several domains, including altruism (e.g., performing acts of kindness), gratitude (e.g., systematically recalling positive life events), using one's personal strengths in a deliberate manner, and optimism (e.g., thinking about past successes and applying these skills to the future).
16017764|NCT02754895|Other|Motivational Interviewing (MI)|"MI is a goal-oriented, patient-centered approach to helping patients resolve their ambivalence to change their health behaviors.
~Each session follows the same structure. Study trainers will: (a) ask participants about their health goals, (b) advise them about current health guidelines and/or refer them to their treatment team, (c) assess readiness to set a goal by identifying how important participants feel the goal is, how confident participants are about making a change, and what the participants' pros and cons for making a change, (d) assist participants in clarifying their goals and problem-solving barriers to reaching those goals, and (e) arrange for the next session by summarizing the participant's plan and scheduling the next session."
16017765|NCT02754882|Drug|Bevacizumab|Avastin® 15 mg/kg IV every 3 weeks on Day 1
16017766|NCT02754882|Drug|SB8|SB8 15 mg/kg IV every 3 weeks on Day 1
16017767|NCT02754882|Drug|Carboplatin|Carboplatin AUC 6 IV every 3 weeks on Day 1 for 4-6 cycles
16017768|NCT02754882|Drug|Paclitaxel|Paclitaxel 200 mg/m2 IV every 3 weeks on Day 1 for 4-6 cycles
16017769|NCT02754856|Biological|Durvalumab|Given IV
16017770|NCT02754856|Other|Laboratory Biomarker Analysis|Correlative studies
16017771|NCT02754856|Procedure|Therapeutic Conventional Surgery|Undergo liver surgery
16017772|NCT02754856|Biological|Tremelimumab|Given IV
16017773|NCT02754843|Device|Phonak's equivalent newly developped power BTE|
16017774|NCT02754843|Device|Equivalent competitor device|
16017775|NCT02754830|Drug|LY3303560 - IV|Administered IV
16017776|NCT02754830|Drug|Saline Solution - IV|Administered IV
16017777|NCT02754830|Drug|LY3303560 - SC|Administered SC
16017778|NCT02754817|Drug|insulin degludec/liraglutide|This is a non-interventional, chart review study and the patients are treated according to current clinical practice and local licenses upon the treating physicians' decision.
16017779|NCT02754804|Device|Biomechanic parameters|recording of biomechanic parameters and surface electromyography at the thigh and calf level throughout the walking period, in PAD patients .
16017780|NCT02754791|Device|Steripath|A device that diverts the first 2 ml of blood drawn in order to reduce contamination
16017781|NCT02754791|Device|Soluprep|Wipes containing alcohol (70%) and chlorhexidine (2%) to achieve skin sterilization
16017782|NCT02754778|Behavioral|conditional workout|6 month of regular conditional workout 1-3 times a weak
16017783|NCT02754765|Drug|Bedaquiline|
16017784|NCT02754765|Drug|Delamanid|
16017785|NCT02754765|Drug|Clofazimine|
16017786|NCT02754765|Drug|Levofloxacin|
16017787|NCT02754765|Drug|Moxifloxacin|
16017788|NCT02754765|Drug|Linezolid|
16017789|NCT02754765|Drug|Pyrazinamide|
16017790|NCT02754765|Drug|Control arm MDR-TB regimen, consistent with WHO guidelines|Control arm MDR-TB regimen, consistent WHO guidelines
16017791|NCT02754752|Procedure|Electroacupuncture Therapy|Undergo electroacupuncture therapy
16017792|NCT02754752|Procedure|Electroacupuncture Therapy|Undergo modified electroacupuncture therapy
16017793|NCT02754752|Other|Laboratory Biomarker Analysis|Correlative studies
16017794|NCT02754752|Other|Quality-of-Life Assessment|Ancillary studies
16017795|NCT02754752|Other|Questionnaire Administration|Ancillary studies
16017796|NCT02754739|Drug|Pravastatin|Pravastatin 40mg once daily for 24 weeks and nutritional education by a nutritionist
16017797|NCT02754739|Drug|Placebo (for Pravastatin)|Pill manufactured to mimic pravastatin 40mg tablet once daily for 24 weeks and nutritional education by a nutritionist
16017798|NCT02754739|Behavioral|Nutritional education only|Only nutritional education by a nutritionist
16088073|NCT02251132|Drug|RTV low|
16017802|NCT02754726|Drug|Cisplatin|25 mg/m2 over 60 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
16017803|NCT02754726|Drug|Gemcitabine|1000 mg/m2 over 30 minutes IV infusion on days 1, 8 and 22, 29 per 42 day cycle
16017804|NCT02754700|Other|Neuromuscular Training|Standardized, comprehensive neuromuscular training
16017805|NCT02754700|Other|Hip Focused ROBUST Training|Biofeedback training focused on the hip extensors
16017806|NCT02754700|Other|Knee Focused ROBUST Training|Biofeedback training focused on knee abduction
16017807|NCT02754687|Drug|Placebo|Placebo with capsules that look like the 11β-MNTDC capsules but with no active ingredients
16017808|NCT02754687|Drug|11βmethyl nortestosterone dodecylcarbonate|Escalating doses of 100, 200, 400, and 800 mg 11β-MNTDC
16017809|NCT02754674|Procedure|type of anterior cruciate ligament reconstruction|comparison of different types of anterior cruciate ligament reconstruction. transportal technique is double bundle graft using flexible reamer, outside-in technique is single bundle graft with remnant preservation
16017810|NCT02754661|Device|COLON Capsule endoscopy|
16017811|NCT02754661|Device|Computed Tomographic Colonography|
16017812|NCT02754648|Procedure|laparoscopic ovarian endometriotic cyst|
16017813|NCT02754635|Other|Induction of labour|Induction of labour
16017814|NCT02754635|Other|Expectant management|Expectant management
16017815|NCT02754622|Other|Observational Group|Indirect calorimetry measurement during Physical Rehabilitation. Observing planned physical rehabilitation session to determine the rehabilitation activity achieved with IC utilised to determine the number of calories used per session
16017816|NCT02754609|Other|Gluten micro-challenge|From week 12 to week 24, all participants will start a gluten micro-challenge from 10mg/day for the first 2 weeks escalating over the this period to 50mg/day at the end of week 24.
16017817|NCT02754609|Other|Inadvertent gluten challenge|From week 24 to week 36, all participants will be on gluten 50mg/day and 1g twice weekly.
16017818|NCT02754609|Other|Moderate gluten challenge|From week 36 to week 42, all participants will be on gluten 2g/day.
16017819|NCT02754609|Other|Liberal diet|From week 42, all participants will be unblinded and those who have received hookworm therapy have the option to go on a liberal diet of more than 10g of gluten/day from week 42 to week 94.
16017820|NCT02754609|Other|Necator americanus-hookworm larvae L3-10|A total of 40 participants at week 0 and week 8 will have hookworms L3-10 present in 2-3 drops of water applied to their skin and then covered in a light dressing.
16017821|NCT02754609|Other|Tabasco® Sauce|Arm: Placebo Comparator: Tabasco® Sauce A total of 10 participants at week 0 and week 8 will have Tabasco® Sauce present in 2-3 drops of water applied to their skin and covered in a light dressing
16017822|NCT02754609|Other|Necator americanus-hookworm larvae L3-20|A total of 40 participants at week 0 and week 8 will have hookworms L3-20 present in 2-3 drops of water applied to their skin and then covered in a light dressing.
16017823|NCT02754609|Other|Gluten free diet|From week 0 to week 12, all participants will be on a gluten free diet.
16017824|NCT02754596|Drug|Travoprost Intraocular Implant, high elution|Surgical implant placed within the eye to elute travoprost.
16017825|NCT02754596|Drug|Travoprost Intraocular Implant, low elution|Surgical implant placed within the eye to elute travoprost
16017826|NCT02754596|Drug|Timolol Maleate Ophthalmic Solution, 0.5%|Instillation of one drop of timolol in the study eye twice daily
16017827|NCT02754583|Behavioral|Water, sanitation, and hygiene (WASH) intervention|WASH arm: Communities will receive the water, sanitation, and hygiene (WASH) intervention including water point construction and maintenance, hygiene and sanitation education and promotion, community-based hygiene promotion workers, household wash stations, household WASH education books, household soap distribution, and a hygiene curriculum for primary schools.
16017828|NCT02754583|Behavioral|Standard of care WASH intervention|Stand of care WASH arm
16017829|NCT02754583|Drug|Azithromycin|20mg/kg
16017830|NCT02754583|Drug|Tetracycline|Tetracycline will be administered in lieu of azithromycin if individual is under 6 months, has a known azithromycin allergy, or is severely ill.
16017831|NCT02754583|Other|Control|The control group will receive no intervention during the trial. They will be enrolled in mass antibiotic treatment at the conclusion of the trial.
16017832|NCT02754570|Drug|Pilocarpine|Pilocarpine will be administered 4 times in addition to latanoprost.
16017833|NCT02754557|Other|Breath-Focused Meditation|"Participants will attend two breath-focused meditation sessions per week for three weeks. During the breath focus task, participants are asked to alternatively focus their breathing (1.5 minutes of breathing and 15 seconds of rest). Participants will be asked to attend to the changing patterns of physical sensations as the breath moves in and out of your body. Focus your awareness on any sensations you may experience (e.g., your abdominal wall rising). Follow the sensations as you breathe in and all the way through until your breath leaves your body."
16017834|NCT02754557|Other|Physiological Feedback|Participants will receive breath feedback, via dynamic velocity estimates from a respiration belt, which allows an analog of breath to be felt as vibration on their wrist via a tactile transducer on a table. The transducer is tuned to produce low frequencies so there is more vibration and less of an audible component than a regular speaker would produce.
16017835|NCT02754544|Procedure|Direct Electrocortical Stimulation|Undergo direct electrocortical stimulation
16017836|NCT02754544|Other|Electrocorticography|Undergo electrocorticography
16017837|NCT02754531|Device|USG|USG used was SonoSite® M-Turbo Bothell, WA, USA, probe linear (Array HFL 38 frekuensi 6-13 MHz). Internal subglottic diameter equals external diameter of the uncuffed endotracheal tube or trachea diameter, result rounded to the smallest uncuffed endotracheal tube size.
16017838|NCT02754531|Other|Cole Formula|Internal diameter of the uncuffed endotracheal tube equals (age in years/4) + 4mm.
16017839|NCT02754518|Drug|Entresto|
16017869|NCT02754284|Biological|Functional collagen scaffold transplantation|Injectable collagen scaffold combined with adipose derived stem cells that are isolated from abdominal adipose tissue will be injected into vocal cord beneath mucous under surgery microscope.
16017870|NCT02754271|Other|Fit for Dialysis|A 15-minute research-based film that explores the barriers and facilitators regarding exercise participation by older hemodialysis patients and support by nephrology staff and family caregivers, and a 16-week exercise program involving activities during dialysis, at home, and in the community.
16088074|NCT02251132|Drug|Ritonavir high|
16017840|NCT02754505|Other|Early rehabilitation|The early rehabilitation program consisted of a coordinated exercise therapy and neuromuscular electrical stimulation, for two hours and five days a week until discharge from the acute hospital. Exercise therapy included strength training (three days/week, one to three sets of 12-15 repetitions, 8-10 exercises involving the major muscle groups: thighs, calves, buttocks, trunk, shoulder girdle), aerobic exercise (large muscle activities five days/week, 10-30 min/session, 50-80% maximal heart rate) and active breathing techniques. For neuromuscular electrical stimulation we applied Compex-P© devices producing biphasic symmetric impulses with a frequency of 50 Hz and a pulse width of 0.35 ms (stimulus regime: 8 s on/24 s off) five days/week, 30 min/session involving the anterior thighs and buttocks.
16017841|NCT02754505|Other|Usual care|exercise therapy, respiratory therapy, neuromuscular electrical stimulation (as described above).
16017842|NCT02754492|Device|Trima Accel System with Version 7.0 Software|Platelet Apheresis Procedure
16017843|NCT02754479|Device|Nd:YAG laser|Treatment of lower extremity spider veins
16017844|NCT02754466|Other|Subjective vs objective criteria in selective excavation|Subjective vs Objective criteria (Polymer burs) to perform selective excavation of dentin caries in deep lesions
16017845|NCT02754466|Other|Glass-ionomer vs Bulk fill composites in the ART approach|High-viscosity glass-ionomer vs Bulk fill composite to restore shallow and medium depth dentin lesions using the ART approach
16017846|NCT02754453|Behavioral|Behavioral lifestyle intervention|20 session lifestyle behavioral intervention with the goal of altering diet and physical activity and decreasing problematic behaviors associated with weight regain and session behavioral intervention addressing increasing physical activity, improving adherence to dietary recommendations and altering problematic eating behaviors.
16017847|NCT02754440|Device|Trima Accel System with Version 7.0 Software|Platelet Apheresis Procedure
16017848|NCT02754427|Behavioral|Prospective Surveillance Group|Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the surveillance group underwent the same arm assessment at 3, 6, and 9 months post-surgery. If arm morbidity was detected at any of those time points, then the participant was referred to individual physiotherapy treatment until the issue was resolved.
16017849|NCT02754427|Behavioral|Education Group|Participants received a pre-surgery arm assessment for shoulder mobility, upper body muscle strength, upper body function, and arm volume. Same assessment was repeated at 12 months post-surgery. After surgery, participants randomized to the education group were asked to attend three patient education sessions on nutrition, stress management, and fatigue management of approximately 1 hour, delivered at 3, 6, and 9 months by study staff.
16017850|NCT02754414|Procedure|Apheresis platelet collection|A single apheresis platelet unit will be collected from a healthy adult volunteer subject using the Trima Accel® Automated Blood Collection System. Concurrent plasma will be collected.
16017851|NCT02754414|Other|Refrigerated storage of apheresis platelets in PAS/plasma|The apheresis platelet unit will be stored, without agitation, at 4°C, for up to 20 days.
16017852|NCT02754414|Radiation|Infusion of aliquot of autologous radiolabeled platelets|Fresh and stored aliquots will be labeled with Indium-111. We are administering ≤30 microcuries in both infusions for a total dose of 0.8 mSv.
16017853|NCT02754414|Other|In vitro tests|Tests to evaluate platelet function will be performed on the platelet unit on day of collection and end of storage
16017854|NCT02754401|Other|16 Items|Patients took part in the questionnaire and were examined using the PSI (periodontal screening index).
16017855|NCT02754401|Other|PSI|The PSI scores (0 to 4) were recorded: score 0=healthy, score 1=bleeding, score 2=supra-/subgingival calculus, score 3=probing depths from 3.5mm to max. 5.5mm, score 4=probing depths greater than 5.5mm. Only the highest finding was noted for each sextant. Persons with findings of code 0 to code 2 were classified as non-periodontitis persons (group 1), whereby codes 3 and 4 were considered a probable periodontitis persons (group 2).
16017856|NCT02754375|Procedure|rTMS|
16017857|NCT02754362|Drug|Bevacizumab|Bevacizumab is a humanized monoclonal antibody that targets vascular endothelial growth factor (VEGF), a proangiogenic factor which aids in tumor vessel formation.
16017858|NCT02754362|Biological|Peptide Vaccine|"Vaccine of long synthetic peptides encoding T cell epitopes in tumor associated antigens.
~Vaccine Consists of:
~EGFRvIII peptide 100 mcg IL13Ralpha peptide 100 mcg EphA2 peptide 100 mcg Her2/neu peptide 100 mcg YKL-40 peptide 100 mcg"
16017859|NCT02754362|Drug|Poly-ICLC as immune adjuvant|Poly-ICLC is a toll like receptor 3 agonist which directly activates dendritic cells and triggers natural killer cells to kill tumor cells.
16017860|NCT02754362|Drug|Keyhole limpet hemocyanin (KLH)|Potent Immunogen used in vaccine approaches for a number of diseases including cancer, AIDS, and infectious diseases
16017861|NCT02754349|Device|SphygmoCor version 7, AtCor Medical, Sydney, Australia|Pulse wave velocity, augmentation index and central blood pressure measurement with applanation tonometry before and after electrical cardioversion
16017862|NCT02754336|Behavioral|Cogmed Robomemo, working memory training|
16017863|NCT02754336|Behavioral|Othmer, neurofeedback|
16017864|NCT02754323|Device|Apparatus CODESNA|The inclusion period is evaluated at one month and the participation of each patient is two days. One day or the subject performs the evaluation of chronic stress by CODESNA and following through questionnaires and another day to 3 weeks / one month apart, to perform a second chronic stress measurement with tool CODESNA to evaluate its reproducibility and reliability.
16017865|NCT02754310|Other|Variation of scenarios|Three different scenarios of pediatric asthma exacerbations: a mild exacerbation, a moderate exacerbation, and a severe exacerbation.
16017866|NCT02754310|Other|Repeated scenarios|The same scenario of a moderate pediatric asthma exacerbation is repeated three times.
16017867|NCT02754297|Drug|177Lu-Octreotate|"The induction course will consist in 4 cycles at 8-10 weeks intervals.
~Concomitant amino acids will be administered for renal protection.
~Intra-arterial LuTate administration will be allowed in suitable cases.
~Dosimetry will be based on quantitative SPECT/CT imaging.
~In patients with hormonal symptoms, somatostatine analogues can be given between P-PRRT cycles."
16017868|NCT02754284|Biological|Autologous fat transplantation|Autologous abdominal fat will be injected into vocal cord beneath mucous under surgery microscope.
16017871|NCT02754258|Drug|MPH|60 days on oral methylphenidate administered 2 times daily before lunch and supper.
16088076|NCT02251119|Drug|Tipranavir|
16017873|NCT02754232|Other|Telemedical training|Intervention will involve resistance training and anaerobic training
16017874|NCT02754219|Drug|Evogliptin|DPP4-inhibitor, Evogliptin
16017875|NCT02754193|Other|moderate hypothermia|moderate hypothermia will be induced using the heat controller of the VA-ECMO circuit. Temperature will be maintained between 33°C≤ T°C ≤34°C during 24 hours ± 1h followed by a progressive reheating (0.2±0.1°C/h) to reach 37 °C. Temperature at 37°C ± 0.3°C will be maintained during 48 hours ± 4h after having reached 37 °C.
16017876|NCT02754180|Drug|Gemcitabine|gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles
16017877|NCT02754180|Radiation|TS-1 with radiation|gemcitabine 1g/m2 iv d1, 8, 15, q4wks. 6 cycles. Followed by TS-1 based chemoradiation. TS-1 40mg/m2 bid, 5 days/week, with radiation.
16017878|NCT02754167|Biological|PRS-080#022-DP|Hepcidin antagonism to mobilize iron and to treat anemia
16017879|NCT02754167|Biological|PRS-080-Placebo#001|Placebo comparator
16017880|NCT02754154|Drug|Warfarin|
16017881|NCT02754154|Drug|Apixaban|
16017882|NCT02754154|Drug|Dabigatran|
16017883|NCT02754154|Drug|Rivaroxaban|
16017884|NCT02754141|Biological|BMS-986179|Specified dose on specified days
16017885|NCT02754141|Biological|Nivolumab|Specified dose on specified days
16017886|NCT02754141|Biological|rHuPH20|Specified dose on specified days
16017887|NCT02754128|Behavioral|BeFAST|The motor learning (ML)-based gait-related training program is designed to improve advanced gross motor skills and athleticism. It will involve 45-min sessions twice to three times weekly over 6 weeks for a total of 16 active sessions. A maximum of 7 weeks will be permitted. Each session will consist of 35-min of active training along with a 10-min active warm-up/cool-down that incorporates ML. Children will be given a 3- to 5-min mental motor imagery script to practice on days when they do not have active training sessions. The total number of sessions (combined training/home imagery) will be five per week.
16017888|NCT02754128|Behavioral|BeSTRONG|The functional strength training program is designed to improve gait-related skills. It will involve 45-min sessions twice to three times weekly over 6 weeks for a total of 16 active sessions. A maximum of 7 weeks will be permitted. Each session will consist of 35-min of active training along with a 10-min active warm-up/cool-down. Children will be given a 3- to 5-min home program of strength exercises to practice on days when they do not have active training sessions. The total number of sessions (combined training/home program) will be five per week.
16017889|NCT02754115|Other|Hyperthermic intraperitoneal chemotherapy|Perioperative data of all the patients posted for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy will be collected prospectively
16017890|NCT02754102|Other|Sunscreen Spray- Liquid (BAY987516)|50 μl/cm*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each) on the lower or mid-back.
16017891|NCT02754089|Drug|Rhus Coriaria L.(Rhus)|500 mg twice daily after meals for 6 weeks
16017892|NCT02754089|Drug|Placebo|500 mg twice daily after meals for 6 weeks
16017893|NCT02754076|Drug|AX 250|Chimeric fusion of recombinant human alpha-N-acetylglucosaminidase and truncated human insulin-like growth factor 2 (rhNAGLU-IGF2)
16017894|NCT02754063|Device|PbtO2 probes|PbtO2/ICP/CPP-directed therapy according to international recommendations
16017895|NCT02754063|Other|No PbtO2 probes|ICP/CPP-directed therapy according to international recommendations
16017896|NCT02754050|Device|Tandem Snare|
16017897|NCT02754037|Radiation|Fluorodeoxyglucose (FDG) positron emission tomography (PET)|FDG-PET has been utilized in multiple disease processes that have inflammation as the key driver of the disease and has found potentials to be used for imaging of steatohepatitis. Dynamic PET acquires images at multiple time points and enables parametric imaging of FDG kinetics, providing fundamental quantitative information about the kinetic process of glucose metabolism in the liver tissue. Our group at University of California Davis has developed a novel kernel-based dynamic (KBD) PET imaging method. The resulting KBD PET method has demonstrated a five-fold gain in signal-to-noise ratio (SNR) when tested on a small group of patients with breast cancer. With this substantial SNR gain, the study group believes the approach has great potential to allow accurate characterization of FDG kinetics in the liver.
16017898|NCT02754037|Other|Magnetic resonance imaging (MRI)|Novel non-invasive MRI based tools to assess liver fat and fibrosis. Potential risks include a sensation of claustrophobia. No contrast dye is used and thus no risk of contrast allergy. Inflammation of the liver may be assessed by MRI software after processing of images and does not require additional patient involvement or change in MRI protocol.
16017899|NCT02754037|Other|Liver magnetic resonance (MR) Perfusion|The pre-contrast and contrast-enhanced images of the entire liver will be performed using a General Electric (GE) 1.5-T MRI scanner system. Contrast injection will follow the standard clinical I.V. injection of 0.1 mmol/kg of gadoteridol. The temporal resolution will be ~5 seconds, and the whole dynamic scan lasts for about 5 minutes.
16017900|NCT02754024|Procedure|Total shoulder arthroplasty (TSA)|stemless humeral head implant: Eclipse™ (Arthrex Inc., Naples, FL, USA)
16017901|NCT02754024|Procedure|Hemi shoulder arthroplasty (HSA)|stemless humeral head implant: Eclipse™ (Arthrex Inc., Naples, FL, USA)
16017902|NCT02754024|Device|Eclipse™ (Arthrex Inc., Naples, FL, USA)|stemless humeral head implant
16017903|NCT02754011|Drug|Combination of ribociclib + capecitabine|RIBOCICLIB from 200 to 600mg once daily + CAPECITABINE from 750 to 1000 mg/m² BID, cycles are defined in 21-day periods, 2 weeks on treatment, 1 week off treatment
16017904|NCT02753998|Combination Product|Additional angioplasty with paclitaxel-coated balloon|Additional angioplasty with paclitaxel-coated balloon after conventional angioplasty
16017905|NCT02753998|Combination Product|Additional angioplasty with placebo balloon|Additional angioplasty with placebo balloon after conventional angioplasty
16017906|NCT02753998|Procedure|Conventional angioplasty|
16017907|NCT02753985|Other|Survey|
16017908|NCT02753972|Behavioral|Mindful Eating and Living|8 week mindfulness skills intervention
16017909|NCT02753972|Behavioral|Active Weight Loss Control|8 week active weight loss control group
16017989|NCT02753452|Behavioral|Residential Immersive Life Skills programming|
16017990|NCT02753452|Behavioral|Non-residential life skills programming|
16017991|NCT02753439|Drug|Geistlich Bio Oss|Extraction of Impacted 3rd Molars,
16017992|NCT02753426|Drug|Doxycycline|Doxycycline 20mg capsule by mouth, twice a day for 30 days.
16019528|NCT02741752|Procedure|Decortication|cortical bone perforation
16017910|NCT02753959|Other|Acute Intervention|"Patients will be set up onto their Non Invasive Ventilator and assessed for an hour prior to, during and following secretion clearance and will have the following assessed:
~Electrical impedance tomography (EIT)
~EMGpara
~SpO2
~tcCO2
~Respiratory inductance plethysmography
~EIT will be performed as 2 to 10-minutes recording of quiet breathing before and after each intervention
~Interventions will be set as follows with a 30 minute washout period between modes:
~Manual techniques only
~MIE at low pressure (+30 to -30)
~MIE at high pressure (+60 to -60)"
16017911|NCT02753959|Other|Stable Intervention|"Patients will be set up onto their Non Invasive Ventilator and assessed for an hour prior to, during and following secretion clearance and will have the following assessed:
~Electrical impedance tomography (EIT)
~EMGpara
~SpO2
~tcCO2
~Respiratory inductance plethysmography
~EIT will be performed as 2 to 10-minutes recording of quiet breathing before and after each intervention
~Interventions will be set as follows with a 30 minute washout period between modes:
~Manual techniques only
~MIE at low pressure (+30 to -30)
~MIE at high pressure (+60 to -60)"
16017912|NCT02753946|Drug|ZTI-01|6g ZTI-01 intravenous infusion TID q8 hours
16017913|NCT02753946|Drug|Piperacillin-tazobactam|4.5g piperacillin-tazobactam intravenous infusion TID q8 hours
16017914|NCT02753933|Other|MRI scan|MRI head scan to be performed as the first Secondary Care contact.
16017915|NCT02753933|Other|Neurology Appointment|Outpatient appointment with Neurologist as the first Secondary Care contact
16017916|NCT02753920|Other|voiding trial|1 of 2 tests to assess bladder function after vaginal apex suspension surgery with or without mid-urethral sling
16017917|NCT02753920|Device|Foley catheter|If subject is unable to void adequately, a Foley catheter will be placed as per protocol and the subject discharged home with catheter. The subject will follow up in the office for removal of catheter.
16017918|NCT02753907|Dietary Supplement|Low LA|Individuals who replaced 10 mL soy oil with one apple
16017919|NCT02753907|Dietary Supplement|High LA|Individuals who reduced 1/3 cup of cooked refined rice and consumed 9.9g (9 of 1.1g capsules, 3 capsules at every 3 meals a day) of soy oil as a supplement
16017920|NCT02753894|Drug|ASP1585|Oral
16017921|NCT02753881|Drug|whole liver lobe cTACE doxorubicin|Doxorubicin CTACE administered in a whole liver lobe manner.
16017922|NCT02753881|Drug|superselective cTACE doxorubicin|Doxorubicin CTACE administered in a super-selective (close to the tumor) manner.
16017923|NCT02753868|Behavioral|exercise|Participants will be asked to cycle at mild to moderate intensity for 30 minutes during either 1-st hour of 3-rd hour into treatment
16017924|NCT02753868|Procedure|Hemodialysis treatment|Participants will receive a standard hemodialysis treatment during the study period
16017925|NCT02753855|Drug|Telavancin|A single dose of telavancin as a 1-hour intravenous infusion
16017926|NCT02753842|Device|5 Fitted Condoms, 5 Thin Condoms, 5 Standard Condoms|"Fitted condoms are available in 56 sizes based on combinations of length (approximately 10mm increments) and circumference (approximately 2 mm increments). Fitted condom thickness is 70 microns ± 10 microns. Appropriate condom size is user-determined with a paper template fitting tool graduated with non-sequential numbering and lettering for maximum privacy. Participants also received ten plain foil packets of 10ml commercially available condom-compatible water-based lubricant.
~Thin condoms have dimensions of 185mm ± 10mm length, 53mm ± 2mm width, and 50 microns ± 5 microns thick. Participants also received ten plain foil packets of 10ml commercially available condom-compatible water-based lubricant.
~Standard condoms have dimensions of 185mm ± 10mm length, 53mm ± 2mm width, and 70 microns ± 10 microns thick. Participants also received ten plain foil packets of 10ml commercially available condom-compatible water-based lubricant."
16017927|NCT02753829|Procedure|Cardiovascular rehabilitation program using Kinect of Xbox|"Participants perform a program of specific exercises. The exercise protocol was adapted to the home context and presented two progressive levels of intensity of exercise, having the second level being introduced after 3 months. The exercise protocol was performed at a moderate intensity, initiated, using data from the stress test, maximal heart rate, the Karvonnen formula, with 65% of the reserve heart rate, progressing for 70%.
~It was given the educational component about the control of cardiovascular risk factors and was encouraged to carry out the daily walks."
16017928|NCT02753829|Procedure|Cardiovascular rehabilitation program using paper manual|"Participants perform a program of specific exercises. The exercise protocol was adapted to the home context and presented two progressive levels of intensity of exercise, having the second level being introduced after 3 months. The exercise protocol was performed at a moderate intensity, initiated, using data from the stress test, maximal heart rate, the Karvonnen formula, with 65% of the reserve heart rate, progressing for 70%.
~It was given the educational component about the control of cardiovascular risk factors and was encouraged to carry out the daily walks."
16017929|NCT02753829|Other|Educational component|It was only given the educational component about the control of cardiovascular risk factors and was encouraged to carry out the daily walks.
16017930|NCT02753816|Drug|Tranexamic Acid|
16017931|NCT02753816|Drug|Placebo Comparator|
16017932|NCT02753803|Drug|Evogliptin, Pioglitazone, Evogliptin+Pioglitazone|Evogliptin : Evogliptin 5mg QD Pioglitazone : Pioglitazone 30mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD
16017933|NCT02753803|Drug|Pioglitazone, Evogliptin, Evogliptin+Pioglitazone|Pioglitazone : Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD
16017934|NCT02753803|Drug|Evogliptin, Evogliptin+Pioglitazone, Pioglitazone|Evogliptin : Evogliptin 5mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Pioglitazone : Pioglitazone 30mg QD
16017935|NCT02753803|Drug|Pioglitazone, Evogliptin+Pioglitazone, Evogliptin|Pioglitazone : Pioglitazone 30mg QD Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD
16017936|NCT02753803|Drug|Evogliptin+Pioglitazone, Evogliptin, Pioglitazone|Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD Pioglitazone : Pioglitazone 30mg QD
16017937|NCT02753803|Drug|Evogliptin+Pioglitazone, Pioglitazone, Evogliptin|Evogliptin+Pioglitazone : Evogliptin 5mg QD + Pioglitazone 30mg QD Pioglitazone : Pioglitazone 30mg QD Evogliptin : Evogliptin 5mg QD
16017993|NCT02753426|Drug|Placebo (for Doxycycline)|Inactive pill manufactured to mimic Doxycycline 20mg. Capsule by mouth, twice a for 30 days.
16017994|NCT02753413|Biological|RSV vaccine GSK3003891A|Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.
16019529|NCT02741739|Drug|REGN1033|
16017938|NCT02753790|Radiation|Intensity Modulated Radiotherapy|"Whole brain radiation using IMRT: 60 Gy to gross disease (planning treatment volume [PTV] 60) or 45 Gy to gross disease (PTV 45) and 30 Gy to subclinical sites (PTV 30) over 15 fractions.
~Patients will be treated Monday through Friday (5 days per week) for 3 weeks. Patients with either a single metastasis greater than 15 cubic centimeters (cm) or total volume of metastases greater than 26 cubic cm will receive the lower dose of 45 Gy to visible brain metastases. 45 Gy may also be prescribed per physician discretion.
~Gross disease which has received prior radiosurgery will receive 30 Gy."
16017939|NCT02753777|Other|Questionnaires|
16017940|NCT02753764|Drug|AZD7624|
16017941|NCT02753764|Drug|prednisone|oral prednisone 20 mg bid for one week
16017942|NCT02753764|Drug|Placebo|
16017943|NCT02753751|Other|AKI Alert|"Provider's will receive a pop-up alert in the electronic health record until AKI is documented in the problem list or AKI resolves."
16017944|NCT02753738|Drug|Escitalopram|Tablet 10mg, 21 days
16017945|NCT02753738|Drug|Placebo|Tablet, 21 days
16017946|NCT02753738|Other|3xMR scan (fMRI, DTI, strucutral MRI)|3 Tesla PRISMA MAGNETOM MR scanner; performed at baseline, after 21 days of performing learning paradigms and after 21 days of drug/placebo treatment and re-learning paradigms
16017947|NCT02753738|Behavioral|Association learning paradigm|21 daily internet-based sessions (20min) of learning associations (pairs) of stimuli
16017948|NCT02753738|Behavioral|Association re-learning paradigm|21 daily internet-based sessions (20min) of learning new associations (pairs) of stimuli performed during escitalopram/placebo treatment
16017949|NCT02753725|Drug|Fentanyl|The intervention arm will comprise Fentanyl given at a dose of one microgram per kilogramme body weight administered approximately ten minutes to the end of surgery determined by the time when the mouth gag will be removed.
16017950|NCT02753725|Drug|Normal saline|the placebo arm will be given normal saline at a volume equivalent to Fentanyl dose per body weight,administered approximately ten minutes to the end of surgery determined by the time when the mouth gag will be removed
16017951|NCT02753712|Drug|Fluticasone/Formoterol BAI|
16017952|NCT02753712|Drug|Fluticasone/Vilanterol DPI (Relvar Ellipta DPI)|
16017953|NCT02753699|Drug|Alisporivir|Intervention of interest; follow-up after ALV-active study
16017954|NCT02753686|Drug|Endocrine therapy may include one of the following therapies: letrozole, anastrozole, exemestane, tamoxifen or fulvestrant|
16017955|NCT02753686|Drug|Endocrine therapy in combination with targeted therapy may include: everolimus plus exemestane or CDK4/6 inhibitor plus endocrine therapy|
16017956|NCT02753673|Behavioral|qualitative interviews with patients|
16017957|NCT02753673|Behavioral|questionnaires|
16017958|NCT02753660|Procedure|Traditional sitting position|Subjects were set on traditional sitting position before spinal anesthesia begun.
16017959|NCT02753660|Procedure|Pendant position|Subjects were set on pendant position before spinal anesthesia begun.
16017960|NCT02753647|Drug|Rituximab|
16017961|NCT02753647|Drug|Cyclophosphamide|
16017962|NCT02753647|Drug|Doxorubicin|
16017963|NCT02753647|Drug|Vincristine|
16017964|NCT02753647|Drug|Prednisone|
16017965|NCT02753647|Drug|Chidamide|
16017966|NCT02753634|Behavioral|Square-stepping exercise|Participants are asked to remember and repeat stepping patterns across a gridded mat as shown to them by an instructor.
16017967|NCT02753621|Behavioral|Group singing|Weekly group singing classes led by professional choir instructor, lasting 90 minutes. 12 classes over 12 consecutive weeks.
16017968|NCT02753621|Behavioral|Facilitated Discussion Group|Weekly facilitated discussion group led by Parkinson Disease educator, lasting 90 minutes. 12 sessions over 12 consecutive weeks.
16017969|NCT02753608|Other|Collection of exhaled breath condensate|An sampling device (authorized for this use) will be connected to the expiratory line of the ventilator. Exhaled breath condensates accumulate in a cooled container.
16017970|NCT02753595|Drug|Eribulin mesylate|Eribulin mesylate will be administered at 1.4 mg/m^2 or 1.1 mg/m^2 as intravenous (IV) infusion on Day 1 and 8 of 21-day cycle
16017971|NCT02753595|Drug|Eribulin mesylate|Eribulin mesylate will be administered at 1.4 mg/m^2 or 1.1 mg/m^2, depending on RP2D, as IV infusion on Day 1 and 8 of each 21-day cycle
16017972|NCT02753595|Drug|Eribulin mesylate|Eribulin mesylate will be administered at 1.4 mg/m^2 as IV infusion on Day 1 and 8 of 21-day cycle
16017973|NCT02753595|Other|Biologic: PEGylated recombinant human hyaluronidase (PEGPH20)|PEGPH20 will be administered at 3.0 mcg/kg or 1.6 mcg/kg as IV infusion on Day -1 and 7 of 21-day cycle
16017974|NCT02753595|Other|Biologic: PEGylated recombinant human hyaluronidase|PEGPH20 will be administered at 3.0 mcg/kg or 1.6 mcg/kg, depending on RP2D, as IV infusion on Day -1 and 7 of each 21-day cycle
16017975|NCT02753582|Dietary Supplement|SOD+Gliadin Capsule|
16017976|NCT02753582|Dietary Supplement|Placebo|
16017977|NCT02753569|Other|Imaging - DW-MRI|
16017978|NCT02753569|Radiation|FDG PET-CT|
16017979|NCT02753543|Drug|Chidamide|
16017980|NCT02753530|Drug|Arimoclomol|2 200mg pills taken 3 times per day during breakfast, early afternoon and at bedtime
16017981|NCT02753530|Other|Placebo|2 matched placebo pills to be taken 3 times per day during breakfast, early afternoon and at bedtime
16017982|NCT02753517|Device|Hepatobiliary scintigraphy|hepatobiliary scintigraphy with functional assessment of the future remnant liver before an extended hepatectomy of 4 or more segments
16017983|NCT02753504|Drug|CKD-519|
16017984|NCT02753504|Drug|placebo|
16017985|NCT02753491|Behavioral|Motivational short interview|New designed motivational short interview model
16017986|NCT02753478|Other|intracoronary infusion with saline on 22 and 4°C|"Routine primary percutaneous intervention will be commenced. Patient will be asked to participate in the study.
~Before reperfusion, saline on room temperature will be infused though the occlusion in the infarct related artery using an over the wire balloon catheter during 10 minutes. The balloon will be inflated to prevent reperfusion in that phase. After 10 minutes the balloon will be deflated allowing reperfusion and infusion with saline on 4°C will be continued for 10 minutes. After this, a coronary stent will be placed."
16017987|NCT02753465|Procedure|left colic artery|Laparoscopic D3 Lymph Node Dissection with preservation of left colic artery
16017988|NCT02753465|Procedure|High ligation|Laparoscopic D3 Lymph Node Dissection with ligation above the left colic artery
16017995|NCT02753413|Biological|Boostrix|Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm.
16017996|NCT02753400|Drug|emixustat hydrochloride|Tablet for oral administration
16017997|NCT02753400|Other|Placebo|Placebo tablets for oral administration contain only inactive ingredients
16017998|NCT02753387|Drug|Chlorhexidine|4 mouthwashes during 30 seconds with Eludril Perio 10 ml and 1 application after intubation with Eludril Perio
16017999|NCT02753387|Device|NaCl 0.9 %|4 mouthwashes during 30 seconds with NaCl 0.9 % 10 ml and 1 application after intubation with NaCl 0.9 %
16018000|NCT02753361|Procedure|Ultrasound guidance|In the second arm, ultrasound will be used to guide the regional block
16018001|NCT02753348|Other|Echocardiography|
16018002|NCT02753348|Other|Blood analysis from umbilical cord blood|
16018003|NCT02753348|Other|ECG|
16018004|NCT02753348|Other|Measurement of oxygen saturation|
16018005|NCT02753335|Behavioral|GMI and Desensitization|"Graded Motor Imagery (GMI) is used to treat chronic pain conditions and movement problems related to alterations in the nervous system such as CRPS, postamputation limb pain and back pain. The patient is trained in monitored steps. The three treatment components include left/right discrimination training, motor imagery exercises and mirror observations of the unaffected limb, appearing as the affected limb. They are performed sequentially, but require a flexible approach to suit the individual patient. The imagined movements have been demonstrated to activate motor cortical areas similar to those activated in the actual execution of that movement.
~Desensitization (D) is used to decrease hyperalgesia by repeated tactile stimulation of the affected area with various materials."
16018006|NCT02753335|Behavioral|Desensitization|Desensitization (D) is used to decrease hyperalgesia and allodynia by repeated tactile stimulation of the affected area with various materials.
16018007|NCT02753322|Other|Dual task training|Balance and walking exercises with simultaneously engaging in attention demanding tasks
16018008|NCT02753322|Other|Single-task training|Balance and walking exercises and and attention demanding task performed separately
16018009|NCT02753322|Other|Limbs exercise|Stretching and strengthening exercises
16018010|NCT02753309|Drug|Sirolimus|
16018011|NCT02753283|Drug|denosumab|Semi-annual dose: 60 mg injection; Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
16018012|NCT02753283|Drug|Placebo|Semi-annual saline injection
16018013|NCT02753283|Dietary Supplement|Calcium and Vitamin D|Dietary supplement: Vitamin D 800-1000 IU/daily and Calcium approximately 1200 mg/daily (dietary + supplement)
16018014|NCT02753283|Drug|Zoledronic Acid|One time safety treatment dose: 5 mg infusion
16018015|NCT02753270|Procedure|Short catheter|Ultrasound Guided Foam Sclerotherapy in Great Saphenous Vein, measuring from 6 to 10 mm, with Short Catheter.
16018016|NCT02753270|Procedure|Long catheter preceded by tumescence|Ultrasound Guided Foam Sclerotherapy Transcatheter in Great Saphenous Vein, measuring from 6 to 10 mm, Preceded by Tumescence.
16018017|NCT02753257|Other|Non-Interventional|Non-Interventional
16018018|NCT02753244|Other|Motion Based Cognitive Video Games Software|Intendu FBT motion based cognitive video games software
16018019|NCT02753244|Other|iPad Apps|Commercially available iPad game applications
16018020|NCT02753231|Behavioral|Low physical activity program|Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
16018021|NCT02753231|Behavioral|High physical activity program|Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
16018022|NCT02753231|Behavioral|Low and High physical activity program|Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
16018023|NCT02753231|Behavioral|Conventional physical activity program|One Physical Education sessions / week
16018024|NCT02753218|Drug|Midazolam|
16018025|NCT02753218|Drug|LEO 32731|
16018026|NCT02753205|Drug|Dexmedetomidine|infusion of dexmedetomidine 0.5ug/kg/h for 10 min and after that, infusion of dexmedetomidine 0.4ug/kg/h until the end of surgery
16018027|NCT02753205|Drug|normal saline|infusion of normal saline
16018028|NCT02753192|Other|Patients|Individuals with PD will be enrolled in the study in Aix-en-Provence, France (N = 60) and Lisbon, Portugal (N = 60). Their global motor disability and orofacial motor functions will be assessed with specific clinical rating scales, without (OFF) and with (ON) medical treatment. Two groups of 60 healthy age-matched volunteers will provide the reference for between-group comparisons. Along with the clinical examinations, several speech tasks will be recorded to obtain acoustic and perceptual measures. Self-evaluation questionnaires will be used to assess the psychosocial impact of dysarthria on quality of life.
16018029|NCT02753179|Other|Head Impulse Tests|Head Impulse Tests are performed by the clinician who holds the patient's head in his hands, while he is looking straight at an earth-fixed target; then by turning the patient's head abruptly and unpredictably to the left or right, up or down through a small angle (only 10-20 degrees - not a large angle). 20 impulses in each directions (6) will be performed.
16018030|NCT02753179|Other|Dynamic visual acuity Test (DVAT)|Dynamic visual acuity Test (DVAT) assesses visual acuity during head movement relative to baseline static visual acuity. DVA will be assessed actively during self-generated rotations of the head in different directions.
16018031|NCT02753179|Other|VEMPs & VEMPo|VEMPs & VEMPo are sound evoked muscular contractions of the neck or eye. They are recorded using an evoked response computer, a sound generator, and surface electrodes to pick up neck or eye muscle activation.
16018032|NCT02753179|Other|Dizziness Handicap Inventory|Dizziness Handicap Inventory is a questionnaire that identify difficulties that patient may be experiencing because of dizziness, yielding to a score ranging from 0 to 100
16018033|NCT02753179|Other|Oscillopsia severity questionnaire|Oscillopsia severity questionnaire is a 9 items questionnaires that identify oscillopsia in different circumstances.
16018034|NCT02753166|Drug|Dexamethasone|After six (6) hours of the accident, subject will take 5 mg of DEX in the Emergency Department (ED). Within twenty-four (24) hours, the subjects will send in a saliva sample. After sexen (7) days, subjects will participate in a phone interview. After thirty (30) days, subjects will participate in an online assessment and return for a one month follow-up visit. Subjects will then participate in online assessments at months 3,6,9, and 12 months.
16088077|NCT02251119|Drug|Ritonavir|
16018035|NCT02753153|Procedure|Control surgical protocol|"A connective tissue graft will be harvested to the palate or posterior maxilla tuberosity. The dimension of the graft will be previously calculated according to the socket dimensions. The harvesting site will be made with a single edge incision and sutured with 4.0 silk (uninterrupted suture). The connective tissue graft will be reshaped if necessary to be 1-2mm thick and inserted into buccal pouch and sutured with 2 vertical interrupted sutures to be stabilized on the buccal aspect.
~The connective tissue graft is then positioned to caver the socket and inserted and sutured in the palatal pouch also by the means of vertical interrupted sutures (polypropylen 6.0)."
16018036|NCT02753153|Procedure|Test surgical protocol|The filling biomaterial (Bio-Oss®, Geistlich), previously humidified with a saline solution containing doxycycline (1mg/ml) and inserted into the socket without heavy compaction.
16018037|NCT02753153|Procedure|Socket preservation|"An atraumatic extraction will be performed in order to preserve the socket bone wall as well as the cervical soft tissues.
~Split- thickness pockets will be performed 5-6 mm deep buccally and 3-4 mm deep palatally preserving interproximal papillae. The filling biomaterial (Bio-Oss®, Geistlich), previously humidified with a saline solution containing doxycycline (1mg/ml) and inserted into the socket without heavy compaction. At this level of the surgery, the randomization envelope will be open and either the control or the test surgical protocol will be applied."
16018038|NCT02753140|Drug|Cetuximab|
16018039|NCT02753140|Radiation|radiation|
16018040|NCT02753140|Drug|Docetaxel|
16018041|NCT02753140|Drug|Cisplatin|
16018042|NCT02753127|Drug|Napabucasin|Napabucasin 240 mg will be administered orally, twice daily, with doses separated by approximately 12 hours (480 mg total daily dose).
16018043|NCT02753127|Drug|Fluorouracil|
16018044|NCT02753127|Drug|Leucovorin|
16018045|NCT02753127|Drug|Irinotecan|
16018046|NCT02753127|Drug|Bevacizumab|
16018047|NCT02753114|Drug|Ketamine|Intranasal Ketamine administered via mucosal atomization device at 0.5 - 1 mg / kg IN.
16018048|NCT02753114|Drug|Normal Saline|Intranasal Normal Saline administered via mucosal atomization device.
16018049|NCT02753101|Drug|[18F]-FTC-146|10 mCi± 1 mCi of [18F]FTC-146 intravenously
16018050|NCT02753088|Drug|BCD-063|
16018051|NCT02753088|Drug|Copaxone-Teva|
16018052|NCT02753088|Drug|Placebo|
16018053|NCT02753075|Device|Experimental Oral Rinse 1|Oral rinse containing 1.5% w/w KOX, 0ppm F, pH 4.5
16018054|NCT02753075|Device|Experimental Oral Rinse 2|Oral rinse containing 2.0% w/w KOX, 45ppm F, pH 4.5
16018055|NCT02753075|Other|Placebo Oral Rinse|Oral rinse containing 0% w/w KOX 0ppm F, pH 4.5
16018056|NCT02753075|Drug|Fluoride toothpaste|Oral rinse containing 1000ppm fluoride as sodium monofluorophosphate
16018057|NCT02753062|Drug|bendamustine, rituximab|subjects will receive rituximab 375mg/m2 on day 1 and bendamustine 120mg/m2 by intravenous infusion on day 2 and 3 in the first cycle. From the 2nd to 6th cycle, rituximab will be administered subcutaneously at a fixed dose of 1400mg and bendamustine 120mg/m2 by intravenous infusion on day 1 following administration of rituximab and day 2.
16018058|NCT02753049|Behavioral|Peer led mHelath behavioral intervention|A trained peer adherence coach will schedule five, weekly-60 minute, 'ACCESS' sessions, delivered to participants via remote videoconferencing, using smartphones. Cognitive behavioral strategies will be employed to target beliefs about antiretroviral treatment (ART), knowledge of ART, and adherence self-efficacy.
16018059|NCT02753036|Drug|Chemotherapy|standard combination chemotherapy (paclitaxel +/- carboplatin) if necessary according to treatment guidelines
16018060|NCT02753023|Other|no intervention|No intervention related
16018061|NCT02753010|Procedure|Gastric emptying of carbohydrate-rich beverage|Old women with acute hip fracture with intake of carbohydrate-rich beverage in order to improve metabolic control. Gastric emptying studied for retention in the elderly with acute trauma.
16018062|NCT02753010|Procedure|Gastric emptying of carbohydrate-rich beverage|Old women on waiting list for hip joint replacement with intake of carbohydrate-rich beverage in order to improve metabolic control. Gastric emptying studied as comparator in the elderly without acute trauma..
16018063|NCT02753010|Procedure|Gastric emptying of carbohydrate-rich beverage|Young healthy women with intake of carbohydrate-rich beverage in order to improve metabolic control. Gastric emptying studied as comparator in young women.
16018064|NCT02752997|Other|Pharmacist discharge medication services|Included in arm descriptions
16018065|NCT02752971|Drug|Bupivacaine|
16018066|NCT02752971|Drug|Sodium diclofenac|
16018067|NCT02752958|Drug|stannous fluoride|0.454% w/w (weight per weight) stannous fluoride
16018068|NCT02752945|Other|One-day CBT workshop|One-day long CBT workshop, with between 4-15 participants, facilitated by clinical psychologists. Following introductions, ice breakers and an explanation of the CBT model, CBT techniques are then introduced and practised using a variety of methods. One week after the workshop, any personal goals set during the workshop are reviewed with one of the workshop facilitators in a 'telephone goal review.'
16018069|NCT02752945|Other|Usual care|Usual care afforded by local CAMHS services
16018070|NCT02752932|Other|Drug testing on PDX per Investigator's choice (upto 4)|Drug of Investigator's choice (upto 4 Ontario funded Chemotherapeutics) will be tested on PDX (Patient Derived Xenografts)
16018071|NCT02752919|Drug|Galunisertib|Administered orally
16018072|NCT02752906|Biological|Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid Conjugate Vaccine|0.5 milliliter (mL), Intramuscular
16018073|NCT02752906|Biological|Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine|0.5 mL, Intramuscular
16018074|NCT02752880|Drug|YH1 group|Participants were randomly assigned 1:1 to receive either YH1 or placebo for 12 consecutive weeks.
16018075|NCT02752880|Drug|placebo group|Participants were randomly assigned 1:1 to receive either YH1 or placebo for 12 consecutive weeks.
16018076|NCT02752867|Drug|Jianpi Yishen Huatan Granules|Jianpi Yishen Huatan Granules contain Herba cistanche，Fructus Alpinia Oxyphyllae，Rhodiola rosea, Polygala tenuifolia willd and Coptis chinensis.Jianpi Yishen Huatan Granules dissolved in water of 100 ml ,po, bid of each 90-days cycle. Number of treatment cycles: one
16018077|NCT02752867|Other|the placebo|Treat with the placebo which contain 5% of prescription of Jian Pi Yi Shen Hua Tan Granules and 95% dextrin.The placebo dissolved in water of 100 ml ,po, bid of each 90-days cycle. Number of cycles: one
16088078|NCT02251119|Drug|Loperamide|
16018079|NCT02752841|Dietary Supplement|Nutritional vitamin D repletion and maintenance|Ergocalciferol (50,000 IU weekly for 12 weeks) for vitamin D repletion, ergocalciferol (50,000 IU monthly) or cholecalciferol (1000 IU daily) for maintenance of vitamin D
16018080|NCT02752828|Drug|Insulin glargine/lixisenatide (HOE901/AVE0010)|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
16018081|NCT02752828|Drug|Insulin glargine (HOE901)|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
16018082|NCT02752828|Drug|Oral anti-diabetic drugs|"Pharmaceutical form: tablet
~Route of administration: oral"
16018083|NCT02752815|Drug|Rituximab|
16018084|NCT02752815|Drug|Cyclophosphamide|
16018085|NCT02752815|Drug|Epirubicin|
16018086|NCT02752815|Drug|Vincristine|
16018087|NCT02752815|Drug|Prednisone|
16018088|NCT02752802|Device|Diagnostic Coronary Angiogram|Diagnostic angiographic procedure with the use of the DyeVert System.
16018089|NCT02752776|Drug|Secukinumab|Secukinumab was used as commercially available PFS of 150 mg. Patients received PFS at the site and were instructed to administer Secukinumab as needed (300 mg each application).
16018090|NCT02752763|Drug|%40 diluted Autologous serum|Serum that obtained after centrifugation of blood sample
16018091|NCT02752763|Drug|Preservative free artificial tears(Tears naturale free, Refresh single dose eye drop)|Preservative free artificial tears is a group naming for drops commonly used for drye disease
16018092|NCT02752750|Other|MRI|MR imaging (MRI) at 3 Tesla
16018093|NCT02752724|Drug|Ketamine|Ketamine anesthesia for ECT index course with measurement cerebral metabolic regional oximetry, EEG seizure quality, cognitive scoring and serum metabolites.
16018094|NCT02752724|Drug|Methohexital|Methohexital anesthesia for ECT index course with measurement cerebral metabolic regional oximetry, EEG seizure quality, cognitive scoring and serum metabolites.
16018095|NCT02752711|Procedure|the PECARN clinical decision rule|the PECARN clinical decision rule for the detection of clinically-important traumatic brain injuries in children with minor head trauma
16018096|NCT02752698|Procedure|Micro Hand S robotic surgery|20-70 patients undergo Micro Hand S robotic surgeries
16018097|NCT02752698|Procedure|laparoscopic surgery|20-70 patients undergo laparoscopic surgeries
16018098|NCT02752698|Procedure|da Vinci robotic surgery|20-70 patients undergo da Vinci robotic surgeries
16018099|NCT02752685|Drug|Pembrolizumab|
16018100|NCT02752685|Drug|Nab-Paclitaxel|
16018101|NCT02752659|Procedure|Self-measured arm circumference, therapist-measured arm-circumference, perometer-measured arm circumference|
16018102|NCT02752646|Drug|nepafenac 0.3%|Patients in this group will receive nepafenac 0.3% eye drops once daily after cataract surgery.
16018103|NCT02752646|Drug|ketorolac|Patients in this group will receive ketorolac 0.5% eye drops four times daily after cataract surgery.
16018104|NCT02752633|Drug|Allopurinol|This is a clinical trial comparing the effect of 80 mg/day of febuxostat to 400 mg/day of allopurinol on the urinary excretion of 2,8-dihydroxyadenine in patients with APRT deficiency.
16018105|NCT02752633|Drug|Febuxostat|This is a clinical trial comparing the effect of 80 mg/day of febuxostat to 400 mg/day of allopurinol on the urinary excretion of 2,8-dihydroxyadenine in patients with APRT deficiency.
16018106|NCT02752620|Other|Osteopathic Manipulative Treatment|
16018107|NCT02752620|Other|Exercise Therapy|
16018108|NCT02752594|Biological|probiotic|Probiotic was administered for a period of 14 consecutive days. Saliva was collected on Day 1, before intervention and on Day 15, after intervention
16018109|NCT02752594|Other|placebo|placebo was administered for a period of 14 consecutive days. Saliva was collected on Day 1, before intervention and on Day 15, after intervention
16018110|NCT02752581|Device|Suction drain|A suction drain is used to remove excess fluid from tissues after surgery.
16018111|NCT02752581|Device|No suction drain|A suction drain is used to remove excess fluid from tissues after surgery.
16018112|NCT02752568|Procedure|endometrial scratch|midluteal endometrial scratch using Novak curette under general anesthesia in the cycle preceding stimulation
16018113|NCT02752568|Procedure|assisted hatching|using Octax laser 20120644-laser 5452
16018114|NCT02752568|Procedure|controlled ovarian hyperstimulation|using merional&/ or fostimon doses individualized as judged by patient age & ovarian reserve & monitored by follicular size & serum estradiol
16018115|NCT02752555|Other|Antioxidant (l-cratinine) + modifiable lifestyle factors|All participants were subjected to the same three-month period treatment protocol, which included 1) antioxidant treatment with L-Carnitine (2g daily); 2) frequent ejaculation every 2 days; and 3) minimizing adverse lifestyle factors.
16018116|NCT02752542|Behavioral|Cognitive Behavioral Therapy|CBT will be delivered in a one-to-one face-to-face format by trained Masters or PhD level CBT therapists who will follow a protocol adapted from existing manuals and piloted in the participating centres. Up to 20 sessions will be offered over 18 weeks, initially twice per week, then weekly and later spaced to every other week. The treatment will have core obligatory modules and flexible elements adaptable to participant's maintaining factors.
16018117|NCT02752542|Drug|Pharmacotherapy|Pharmacotherapy will be prescribed and adjusted by psychiatrists in 20-30 minute pharmacotherapy sessions once every two weeks. The manual-guided best-evidence pharmacotherapy will follow current guidelines for first, second and third line treatment.41 The primary focus will be on serotonin-reuptake inhibiting antidepressant (escitalopram 5-20mg, sertraline 50-200 mg daily) monotherapy, which may remain the only treatment for the majority of participants. Augmentation (aripiprazole 2-10mg, bupropione 150-450mg) will be offered to participants with partial response. The manual, developed as part of Canadian Biomarker Integration Network in Depression (CAN-BIND).43, also specifies admissible supportive therapeutic elements and prohibits CBT-specific techniques.
16018118|NCT02752529|Drug|Tacrolimus（FK506）|
16018119|NCT02752516|Drug|Anlotinib|Anlotinib QD po. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
16018120|NCT02752503|Drug|Nalmefene|
16018121|NCT02752490|Drug|Liberal use of maternal oxygen|Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask with any category 2 tracing as defined by ACOG10 at the discretion of the primary nurse or physician
16018154|NCT02752243|Drug|CIK-Cells|IL-15 activated CIK cells individually generated from PB mononuclear cells of the original stem cell donors.
16088327|NCT02249299|Drug|Placebo|
16018122|NCT02752490|Drug|Indicated use of maternal oxygen|Administration of maternal oxygen, 100% FiO2 at 10L/min via nonrebreather face mask only in the setting of a category 2 tracing with recurrent late fetal heart rate decelerations, prolonged fetal deceleration, fetal tachycardia, or minimal to absent fetal heart rate variability lasting 30 minutes or greater. Maternal oxygen is discontinued once these conditions have resolved and may be readministered if they recur.
16018123|NCT02752477|Drug|Opioid-free general anesthetic|An opioid-free general anesthetic technique utilizing dexmedetomidine, ketamine, and lidocaine infusions
16018124|NCT02752477|Drug|Traditional general anesthetic|Traditional general anesthetic technique utilizing sufentanil, fentanyl or remifentanil
16018125|NCT02752464|Behavioral|Counseling|Up to 12 sessions of behavioral counseling using motivational interviewing techniques focused on diet and physical activity behaviors over a 12 week period. Counselors will be guided in their sessions by a computer program called CuesWeight. Participants also receive text messages to enable participants to track their behaviors; this information is relayed to the counselors to inform the counseling sessions.
16018126|NCT02752464|Behavioral|feedback report|All participants receive a brief printed feedback report displaying their current levels of nutrition and physical activity behaviors and tips for meeting recommended guidelines.
16018127|NCT02752451|Other|Non-Anatomic Arthroscopy Simulation|Knee arthroscopy training using Cigar Box Arthroscopy Trainer
16018128|NCT02752451|Other|Anatomic Arthroscopy Simulation|Knee arthroscopy training using Anatomic Knee Arthroscopy Trainer
16018129|NCT02752451|Other|Pre-assesment education|Reading material and lecture with only still images about performing diagnostic knee arthroscopy
16018130|NCT02752438|Device|HFOV|HFOV is a kind of respiratory support with a rate higher than physiological but with lesser volume.
16018131|NCT02752425|Device|Visual feedback|Use of ultrasound echography for tongue articulatory visual feedback
16018132|NCT02752412|Drug|Insulin glargine/Lixisenatide (HOE901/AVE0010)|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
16018133|NCT02752412|Drug|Insulin glargine U100 (HOE901)|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
16018134|NCT02752412|Drug|Metformin|"Pharmaceutical form: tablet
~Route of administration: oral"
16018135|NCT02752386|Behavioral|Biofeedback Training|Participants will received biofeedback training to reduce arousal and pain
16018136|NCT02752373|Device|Brain Sentinel Seizure Detection and Information System|The Brain Sentinel® GTC Seizure Detection and Information System is an ambulatory system designed to continuously monitor and perform real-time analysis of surface electromyography (sEMG) data to detect GTC seizures and to provide an alarm to alert caregivers within 30 seconds of bilateral, appendicular, tonic extension that a seizure is occurring. The System is for recording and storing sEMG data, which is subsequently reviewed by a trained healthcare professional in the outpatient clinical setting. The Brain Sentinel® GTC Seizure Detection and Information System is intended for real time monitoring of pediatric and adult patients who have an arm circumference ranging from at least 16 cm to no greater than 51 cm at the biceps. It may be used in the home or healthcare facilities for real-time monitoring during the day, night, or for continuous monitoring, including during the titration of, or the withdrawal from anti-epileptic drugs.
16018137|NCT02752360|Procedure|Biodegradable Stenting Anastomoses|Biodegradable Stenting Anastomoses(BSA) is a new method and device which helps to make intestinal anastomosis easily. According to the measurement of intestinal canal diameter, chose an appropriate size of BSA and use the Seromuscular layer Purse-string Suture to stitch with an absorbable line (VCP311, Ethicon, Inc.) away from the end 0.5 to 1.0 cm and not knot temporarily, then open and sterilize intestinal canal fully, and place the BSA into the intestinal canal at appropriate position before tightening knot. Last, the interrupted whole layer inversion suture is used to fix.
16018138|NCT02752360|Procedure|Double-layer Hand Sutures|Double-layer Hand Sutures(DHS)is a surgery way that is to use the single-layer continous Hand Sutures,then Lembert to stitch with an absorbable line (VCP311, Ethicon, Inc.).
16018139|NCT02752347|Device|Surface EMG device|measuring the muscles activity using surface EMG device
16018140|NCT02752334|Drug|Magnesium Sulphate|Magnesium has antinociceptive effects in animal and human models, principally related to blocking the N-methyl-D-aspartate (NMDA) receptors and regulation of calcium influx into cells.
16018141|NCT02752321|Device|eDischarge|Patients will be enrolled in the eDischarge technology during their inpatient hospital stay. A completed electronic discharge packet (EDP) will be given to patients on the day of hospital discharge.
16018142|NCT02752308|Drug|Bupivacaine|Injection of Bupivacaine in the epidural space (0.25%, 0.33mg/Kg)
16018143|NCT02752308|Procedure|General anesthesia|Induction with thiopental sodium 5 mg/Kg, atracurium 0.4 mg/Kg and fentanyl 2 mcg/Kg and maintenance with isoflurane and a combination of oxygen and nitrous oxide
16018144|NCT02752308|Drug|Dilute epinephrine injection|Injection of 1/100000 epinephrine solution along all incision lines
16018145|NCT02752308|Drug|Fentanyl|fentanyl 2 mcg /Kg that is repeated during surgery whenever the heart rate or blood pressure increased more than 20% of its baseline
16018146|NCT02752308|Drug|dextrose plus sodium chloride.|Four mL/Kg/hr of 5% dextrose plus 0.04 mL/Kg/hr of 20% sodium chloride. Each mL of blood loss was replaced by 3 ml of Ringer's solution
16018147|NCT02752308|Drug|neostigmine and atropine|Injection of 0.04 mg/Kg of neostigmine and 0.02 mg/Kg of atropine, intravenously at the end of operation.
16018148|NCT02752308|Procedure|Hypospadias repair|Surgical repair of hypospadias, using tubularized incised plate technique
16018149|NCT02752295|Behavioral|stress-coping week|The multidisciplinary team will offer Mindfulness-Based Stress Reduction (MBSR), group psychotherapy (resilience, Cognitive Behavioral Analysis System of Psychotherapy CBASP, psychodynamic therapy), relaxation training, nutrition course, stress-coping and physical training in a group setting.
16018150|NCT02752295|Behavioral|additional two days follow-up weekend|A two-days follow-up which recapitulates previous treatment elements.
16018151|NCT02752282|Other|Anticipatory Counseling|Anticipatory Counseling provides information on expected side-effects that may change or go away over time, or stay for the duration of the treatment. Anticipatory counseling can also help patients understand when their side-effects are normal and when to seek medical attention.
16018152|NCT02752282|Other|Cancer Screening Guidelines|Anticipatory Counseling on United States Preventative Services Task Force (USPSTF) updated pap screening guidelines
16018153|NCT02752256|Drug|Tissue Plasminogen Activator|
16018155|NCT02752230|Procedure|Laparoscopic Roux en Y gastric bypass|Laparoscopic Roux en Y gastric bypass
16018156|NCT02752230|Procedure|Laparoscopic Sleeve Gastrectomy|Laparoscopic Sleeve Gastrectomy
16018157|NCT02752217|Other|Inspiratory Muscle Training|Inspiratory muscle training at 25%MIP with Slow breathing at 6 breath per min with BreatheMAX device for 8 weeks at home
16018158|NCT02752217|Other|Control|Inspiratory muscle training at 2 cmH2O with Slow breathing at 6 breath per min with BreatheMAX device for 8 weeks at home
16018159|NCT02752204|Drug|AZD 2014|AZD2014 125mg BD - 2 days on 5 days off in a 28 day cycle
16018160|NCT02752204|Drug|Rituximab|Rituximab 375mg/m2 will be administered intravenously on day 1 of a 28 day cycle for a total of 6 cycles.
16018161|NCT02752191|Drug|ferumoxytol|ferumoxytol as an MRI contrast agent infused over several minutes
16018162|NCT02752191|Drug|gadofosveset|gadofosveset as an MRI contrast agent injected over several seconds
16018163|NCT02752178|Other|MA|Monoaminergic antidepressant use
16018164|NCT02752178|Other|DEP|Depression measured using the Hamilton Depression (HAM-D) questionnaire
16018165|NCT02752165|Other|TEAM-ED|Facilitation of preventive asthma management through telemedicine assessment and follow-ups in addition to guideline-based provider prompting
16018166|NCT02752165|Other|Enhanced Usual Care|Report of symptoms to primary care physician
16018167|NCT02752152|Behavioral|Computer-assisted counseling|The counselor opens the computer-assisted information/educational interactive counseling program on the tablet computer and invites the participant to use the program.
16018168|NCT02752152|Behavioral|On-demand counseling|The counselor only invites the participants to ask questions about HIV and other STIs.
16018169|NCT02752152|Behavioral|Standard counseling|The counselor gives face-to-face general information/education
16018170|NCT02752152|Behavioral|Appointment + reminder|Has an appointment and receive reminders for further testing
16018171|NCT02752152|Behavioral|Reminder|Only receive reminders for further testing
16018172|NCT02752152|Behavioral|No appointment and no reminder|No appointment and no reminders for further testing
16018173|NCT02752126|Radiation|Conventional radiotherapy|Patients will receive standard palliative radiation in dose of 30Gy in 10 fractions, or 20Gy in 5 fractions.
16018174|NCT02752126|Radiation|Esophageal-Sparing Intensity-Modulated Radiotherapy|Patients will receive esophageal-sparing intensity-modulated radiotherapy, of 30Gy in 10 fractions or 20Gy in 5 fractions.
16018175|NCT02752113|Drug|Empagliflozin and Linagliptin|Empagliflozin and Linagliptin
16018176|NCT02752113|Drug|Metformin and Insulin sc|Metformin and Insulin sc
16018177|NCT02752100|Procedure|Percutaneous transluminal angioplasty|
16018178|NCT02752087|Drug|LY900014|Administered SC
16018179|NCT02752074|Drug|pembrolizumab + epacadostat|"Pembrolizumab will be administered intravenously every 3 weeks starting at Day 1 (Week 1)
~Epacadostat will be administered orally daily starting at Day 1 (Week 1)"
16018180|NCT02752074|Drug|pembrolizumab + placebo|"Pembrolizumab will be administered intravenously every 3 weeks starting at Day 1 (Week 1)
~Placebo will be administered orally daily starting at Day 1 (Week 1)"
16018181|NCT02752061|Other|Potlako intervention|"Multicomponent intervention including:
~provider training on early detection and diagnostic approaches to cancer
~patient education on importance of obtaining timely cancer diagnosis
~provision of a patient navigator to facilitate diagnosis and entry into care
~provision of transportation support to vulnerable patients"
16018182|NCT02752048|Drug|TAS-205|2 groups: Low dose group, High dose group. Oral administration for 24 weeks, bis in die (BID) after meal
16018183|NCT02752048|Drug|Placebo|1 group: Placebo group. Oral administration for 24 weeks, BID after meal
16018186|NCT02752009|Procedure|Axillary Lymph Node Sampling Clip|
16018187|NCT02751996|Drug|SB 9200|SB 9200
16018188|NCT02751996|Drug|Placebo|
16018189|NCT02751996|Drug|Tenofovir|
16018190|NCT02751983|Behavioral|ACT for Life|A novel protocol detailing the application of Acceptance and Commitment Therapy (ACT) to recovery from suicidal crises. Consists of three modules designed to be delivered in three to four 60-minute individual talk therapy sessions. Nearly all of the metaphors and experiential exercises are adaptations of core ACT techniques included in various empirically-supported applications of ACT to other health conditions. Additionally, the adjunctive intervention is designed to augment safety planning (a hierarchical list of strategies to recognize and cope with a suicidal crisis).
16018191|NCT02751983|Other|Treatment as usual|All participants will be able to engage in treatment as usual. Psychiatric inpatient care typically consists of behavioral mental health group and/or individual therapy and pharmacological treatment. Outpatient care is offered upon discharge. This typically consists of both group and individual therapy and medication management.
16018192|NCT02751970|Procedure|Dental restoration|Methacrylate resins will be used to complement the cavity restoration after of adhesive procedure
16018193|NCT02751970|Procedure|3 step ER|Enamel and dentin will be conditioning with 35% phosphoric acid, then applied primer, and then applied adhesive resin.
16018194|NCT02751970|Procedure|2 step ER|Enamel and dentin will be conditioning with 35% of phosphoric acid, then applied primer/adhesive resin.
16018195|NCT02751970|Procedure|2 step SE|Enamel and dentin will be conditioning with acidic primer, then applied primer/adhesive resin.
16018196|NCT02751970|Procedure|1 step SE|Enamel and dentin will be conditioning with acidic primer/adhesive resin.
16018197|NCT02751957|Behavioral|Early Start Denver Model|The Early Start Denver Model is an evidence based, behavioral intervention for young children who have an autism spectrum disorder. It is a behavioral treatment informed by the principles of applied behavior analysis.
16018198|NCT02751944|Dietary Supplement|NEM|Dietary supplement for the support of joint health.
16018199|NCT02751944|Dietary Supplement|Placebo|Placebo
16018279|NCT02751294|Drug|Tafenoquine Control|It will be supplied as a dark pink, capsule-shaped, film-coated tablet plain on both sides containing 150 mg tafenoquine
16018280|NCT02751294|Drug|Tafenoquine dissolution profile X|"It will be supplied as a dark pink, capsule-shaped, film-coated tablet plain on both sides containing 150 mg tafenoquine and will be intermediate aged TQ Product."
16018403|NCT02750306|Drug|Suvorexant|10 mg tablet (may be increased to 20 mg tablet)
16018200|NCT02751931|Drug|Mirabegron|Participants received initial dose of 25 mg of mirabegron PED25 orally once daily. At weeks 2, 4 or 8, participants were up-titrated to PED50 based on the given dose titration criteria. Following week 24, participants stayed on their individual dose level until week 52 EOS or EOT. Participants with a body weight >=35 kg received mirabegron tablets or body weight <35 kg received mirabegron oral suspension. At week 24, participants on mirabegron oral suspension could switch to tablets if the body weight became >=35 kg or participants on mirabegron tablets could switch to oral suspension if the body weight became <35 Kg or participants could switch to either of the dosage form for acceptability reasons after sponsor's prior approval and on a case-by-case basis. Mirabegron extended-release granules were reconstituted with water to prepare a mirabegron oral suspension of 8 mg/mL. Administration was via an oral syringe with a sip of water afterwards.
16018201|NCT02751918|Drug|Anetumab ravtansine (BAY94-9343)|Anetumab ravtansine will be administered on Day 1 of every 21-day treatment cycle.
16018202|NCT02751918|Drug|Pegylated Liposomal Doxorubicin|Pegylated liposomal doxoribicin will be administered on Day 1 of every 21-day treatment cycle.
16018203|NCT02751905|Drug|BIIB074|Administered orally as specified in treatment arm
16018204|NCT02751892|Behavioral|Active lifestyle programme|The intervention is an activity lifestyle programme to increase physical activity behaviour post-intervention and to facilitate behaviour change maintenance at 3 months post-intervention.
16018205|NCT02751866|Dietary Supplement|Berry fruit powder OR nutritional ketosis|Daily supplementation with berry fruit powder OR carbohydrate restriction to achieve nutritional ketosis
16018206|NCT02751866|Dietary Supplement|Placebo powder OR higher carbohydrate|Daily supplementation with placebo powder OR higher carbohydrate intake
16018207|NCT02751853|Device|Conductance catheter|Continuous online measurements of left ventricular pressure and volume using conductance catheters
16018208|NCT02751840|Dietary Supplement|Caffeine|200 mg of caffeine capsule before RMR measurement
16018209|NCT02751840|Dietary Supplement|Placebo|Placebo capsule (starch) before RMR measurement
16018210|NCT02751840|Other|Coffee|9 grams of black coffee in boiling water consumed before RMR measurement
16018211|NCT02751840|Other|Decaffeinated|9 grams of decaffeinated black coffee in boiling water consumed before RMR measurement
16018212|NCT02751827|Other|Blood sample|"One blood sample before treatment initiation (Cycle 1 Day predose) for pharmacogenomics
~One blood sample at the end of the firth month of treatment (postdose) for pharmacokinetic"
16018213|NCT02751801|Other|no intervention|
16018214|NCT02751762|Other|Observation Only|No Intervention
16018215|NCT02751749|Behavioral|Unified Protocol|
16018216|NCT02751736|Dietary Supplement|CJLP243|Perioperative administration till postoperative weeks 3
16018217|NCT02751736|Dietary Supplement|Placebo|Perioperative administration till postoperative weeks 3
16018218|NCT02751723|Other|validated questionnaires|
16018219|NCT02751710|Other|Whole-body FDG PET-CT alone|FDG PET-CT imaging
16018220|NCT02751671|Procedure|POCUS|The use of Point-of-care ultrasound before urine sample procedure
16018221|NCT02751671|Procedure|Standard|Urine sampling procedure without prior ultrasound
16018222|NCT02751658|Other|mouth swab|Levy to make inside of the mouth with a swab on the day of admission to hospital and the day of release at the patients in the Otorhinolaryngology
16018223|NCT02751645|Procedure|Acute Normovolemic hemodilution|ANH is a technique in which a portion of the patients' own blood is removed before any surgical bleeding occurs. It is stored until the end of the operation, at which point it is returned to the patient.
16018224|NCT02751632|Behavioral|Support and Problem Solving Therapy|Support and Problem Solving Therapy involves providing participants with emotional support and helping them to resolve their problems in day-to-day life.
16018225|NCT02751632|Behavioral|Cognitive Behavioural Case Management|CBCM has a number of different elements including: strategies to help with stress management; therapy that targets thinking and behavioural patterns; practical assistance, as well as yoga and mindfulness.
16018226|NCT02751632|Drug|Fluoxetine|Participants will commence on 1 capsule of fluoxetine 20 mg, to be taken in the morning. The medication can be increased to fluoxetine 40 mg daily if there has been a poor clinical response after the first 6 weeks of treatment.
16018227|NCT02751632|Drug|Placebo|Participants will commence on 1 capsule of the placebo pill, to be taken in the morning. The medication can be increased to 2 placebo capsules if there has been a poor clinical response after the first 6 weeks of treatment.
16018228|NCT02751632|Behavioral|3-monthly monitoring|Study participants will be contacted on a 3-monthly basis by a study clinician who will be assessing the participant's risk.
16018229|NCT02751619|Drug|Lidocaine patch 5%|Lidocaine patch 5% was applied to cover the planned skin incision for 12 hours during the night and then was removed for the subsequent 12 hours during the day. This process was continued for 3 days before thoracotomy
16018230|NCT02751619|Drug|Placebo patch|A patch without lidocaine was applied to cover the planned skin incision for 12 hours during the night and then was removed for the subsequent 12 hours during the day. This process was continued for 3 days before thoracotomy
16018231|NCT02751606|Drug|ferumoxtran-10|ferumoxtran-10 will be administered intravenously one day prior to the MRI scan
16018232|NCT02751606|Device|7 Tesla MRI|Subjects undergo a 7 Tesla MRI scan
16018233|NCT02751606|Device|3 Tesla MRI|Subjects undergo a 3 Tesla MRI scan
16018234|NCT02751593|Drug|Dexamethasone|dexamethasone 40mg/d for 4 days
16018235|NCT02751580|Other|Telemedicine|Attend a virtual visit via the JeffConnect telehealth app
16018236|NCT02751580|Other|Questionnaire Administration|Ancillary studies
16018237|NCT02751567|Other|BAY987516|50 μl/ cm2 of the test article is applied directly to two sites on the skin and covered with the appropriate patch. 24 hours later, the patches are removed. The test sites are lightly wiped with a dry cloth/tissue and 3μl/ cm2 of test article is reapplied directly to the skin of the test site designated for irradiation, and lightly spread over the test site. 48 hours later the procedure is repeated to the same test sites. This process is repeated twice weekly for a total of six exposures.
16018238|NCT02751567|Other|Untreated skin|One site is patched without treatment as control
16018281|NCT02751294|Drug|Tafenoquine SIL|It will be compounded at site and will be administered as 0.3 mg/mL (100mL to be dosed, equivalent to 30 mg) aqueous Solution of SIL Tafenoquine.
16018404|NCT02750306|Drug|Placebo|Placebo to suvorexant
16018239|NCT02751541|Drug|Sunscreen Sport Spray (BAY987519)|50 μl/cm*2 or 0.05 gm/cm*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each). After the test articles have dried for 5 to 15 min, the sites are covered by the appropriate patch.24 hours later, the set of patches covering the product are removed. Three (3) μl/ cm2 or 0.003 gm/cm*2 of the test product is reapplied to the test site, air dried for 5 to 15 minutes for volatilization and then the test site is exposed to UVA radiation.(Formulation number - RB#Y51-002)
16018240|NCT02751541|Other|Untreated Skin|This site is patched without treatment as irradiated control.
16018241|NCT02751528|Biological|ETBX-021|ETBX-021 is a HER2-targeting vaccine comprising an Ad5 vector and a modified HER2 gene insert.
16018242|NCT02751515|Other|Bain De Soliel - Solid|0.05gm/ cm2 of the test article is applied directly to two sites on the skin and covered with the appropriate patch. 24 hours later, the patches are removed. The test sites are lightly wiped with a dry cloth/tissue and 3μl/ cm2 of test article is reapplied directly to the skin of the test site designated for irradiation, and lightly spread over the test site. 48 hours later the procedure is repeated to the same test sites. This process is repeated twice weekly for a total of six exposures.
16018243|NCT02751515|Other|Untreated skin|One site is patched without treatment as control
16018244|NCT02751502|Device|m2 Bimanual Arm Trainer (BAT)|Patients in the device group will be asked to train specific movements repeatedly with the device for 45 minutes five days a week for 6 weeks and compliance will be monitored through training logs and remotely
16018245|NCT02751489|Other|Bain De Soliel - Solid|0.05 gm/cm2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each) on the lower or mid-back. After the test articles have dried for 5 to 15 min, the sites are covered by the appropriate patch.
16018246|NCT02751476|Other|Point of Use (PoU) water treatment flocculent disinfectant.|A household level point of use water treatment of a flocculent disinfectant will be tested.
16018247|NCT02751476|Other|Point of Use (PoU) water treatment chlorine disinfectant|A household level point of use water treatment of a chlorine disinfectant will be tested.
16018248|NCT02751476|Device|Point of Use (PoU) ceramic water filter|A household level point of use water treatment of a ceramic water filter will be tested.
16018249|NCT02751476|Other|Standard Severe Acute Malnutrition Treatment|Standard CMAM treatment.
16018250|NCT02751463|Drug|Sunscreening Sport Spray Rest (BAY987519)|50 μl/ cm*2 of the test article is applied directly to two sites on the skin and covered with the appropriate patch. 24 hours later, the patches are removed. The test sites are lightly wiped with a dry cloth/tissue and 3μl/ cm2 of test article is reapplied directly to the skin of the test site designated for irradiation, and lightly spread over the test site. 48 hours later the procedure is repeated to the same test sites. This process is repeated twice weekly for a total of six exposures.(Formulation Number - RB# Y51-002 )
16018251|NCT02751463|Other|Untreated skin|One site is patched without treatment as control
16018252|NCT02751450|Device|Stannous Fluoride dentifice|Experimental dentifrice containing 0.454% w/w stannous fluoride (1100ppm)
16018253|NCT02751450|Other|Sodium Monofluorophosphate dentifrice|Dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride)
16018254|NCT02751437|Dietary Supplement|Arginine|
16018255|NCT02751424|Drug|GSK3342830|A pyrogen free lyophilized formulation, white to yellowish brown powder containing 1000 mg of GSK3342830A (as free base) per vial. The reconstituted solution looks like a clear, colorless to yellow or brownish yellow liquid, free from visible particulate matter will be administered as IV infusion over 1 hour.
16018256|NCT02751424|Drug|Placebo|A clear and colorless solution containing 0.9% sodium chloride. It will administered as IV infusion over 1 hour.
16018257|NCT02751411|Device|micro-enema with Promelaxin|The intervention has a lubricating, protective action on the anus and rectum and a balanced osmotic action which elicits the evacuation reflex.
16018258|NCT02751411|Drug|Macrogol 4000|Stool softener
16018259|NCT02751398|Drug|Dapagliflozin 10mg|
16018260|NCT02751398|Drug|Placebo 10mg|Matching placebo for dapagliflozin 10 mg
16018261|NCT02751385|Drug|Microgynon|
16018262|NCT02751385|Drug|Nintedanib|
16018263|NCT02751372|Drug|BAY 987517|50 μl/cm*2 or 0.05 gm/cm*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each). After the test articles have dried for 5 to 15 min, the sites are covered by the appropriate patch.24 hours later, the set of patches covering the product are removed. Three (3) μl/ cm2 or 0.003 gm/cm*2 of the test product is reapplied to the test site, air dried for 5 to 15 minutes for volatilization and then the test site is exposed to UVA radiation.
16018264|NCT02751372|Other|Untreated Skin|This site is patched without treatment as irradiated control
16018265|NCT02751359|Drug|Cannabidiol|200, 400, or 800 mg Cannabidiol
16018266|NCT02751359|Drug|Placebo|0 mg Cannabidiol
16018267|NCT02751333|Procedure|FCSEMS with Endostitch (ES)|The fixation of FCSEMS using endostitch (ES) with the OverStitchTM system to prevent migration.
16018268|NCT02751333|Procedure|FCSEMS with No Suturing (NS)|The insertion of FCSEMS with no suturing.
16018269|NCT02751333|Device|Fully Covered Self-Expanding Metal Stents (FCSEMS)|This is the stent that will be used to treat the esophageal pathology in both groups
16018270|NCT02751333|Device|EndoStitch (ES) with the OverStitchTM system|This is the device used to apply the stitches to the stent in participants randomized to stent suturing.
16018271|NCT02751320|Drug|0.425 % w/w phytate,1150ppm F|Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.
16018272|NCT02751320|Drug|0.85 % w/w phytate,1150ppm F|Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.
16018273|NCT02751320|Drug|0.85 % w/w phytate,0.3%ZnCl2 0.5% sodium citrate, 1150ppm F|Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.
16018274|NCT02751320|Other|0 ppm F|Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.
16018275|NCT02751320|Drug|1150ppm F|Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.
16018276|NCT02751320|Drug|0.3%ZnCl2, 0.5% sodium citrate, 1150ppm F|Participants were assigned with 1.5±0.1g twice daily dentifrice for one timed minute.
16018277|NCT02751307|Drug|metformin 500 mg|metformin 500 mg QAM for metformin 500 mg/d group; metformin 500 mg 1 BID for metformin 1000 mg/d
16018278|NCT02751307|Drug|clozapine 100 mg|Clozapine dose remained unchanged during metformin intervention period in recruited patients.
16018282|NCT02751281|Procedure|Pneumatic percutaneous nephrolithotomy|Pneumatic percutaneous nephrolithotomy is type of surgery that we use pneumatic lithotripter to treat kidney stone
16018283|NCT02751281|Procedure|Ultra-sonic percutaneous nephrolithotomy|Ultra-sonic percutaneous nephrolithotomy is type of surgery that we use ultra-sonic lithotripter to treat kidney stone
16018284|NCT02751268|Drug|Normal Saline|Bilateral infraorbital and infratrochlear nerve block before general anesthesia with normal saline
16018285|NCT02751268|Drug|Ropivacaine|Bilateral infraorbital and infratrochlear nerve block before general anesthesia with 0.5% ropivacaine
16018286|NCT02751255|Drug|all-trans retinoic acid (ATRA)|Phase 1 and 2: daratumumab 16 mg/kg, first 8 infusions are given weekly, then 8 infusions every 3 weeks, then every 4 weeks until progression Phase 1: ATRA 15, 30, or 45 mg/m2/day for 3 days. Phase 2: ATRA will be administered twice daily as an oral formulation at the MTD dose, or if no MTD is reached, at the dose of 45 mg/m2/day for 3 days. The first administration of ATRA will be given in the morning, two days before the scheduled daratumumab infusion. The last administration of ATRA will be given in the evening of the day that daratumumab was administered (days -2, -1, and 0; day 0 is the day of daratumumab infusion).
16018287|NCT02751229|Behavioral|Honest Open Proud (HOP)|"five lessons in three modules, two for each two-hour session
~Considering pros and cons of disclosing:
~hurtful and helpful attitudes about mental illness
~identify beliefs participants hold about themselves
~explore five-step process to challenge their personally hurtful beliefs
~weigh pros and cons of coming out in order to facilitate a decision on whether to disclose
~Different ways to disclose:
~different levels of (non-) disclosure and how to weigh the cons and pros
~disclosure via social media versus disclosing face to face
~how to find people that are better to disclose to than others and how to 'test them out'
~participants will discuss how others might respond to their disclosure and how that will affect them
~Telling your story:
~how to tell one's story in a personally meaningful way, how to identify peers who might help with the coming out process, to review how telling one's story felt"
16018288|NCT02751216|Other|EEG recording + pain protocol|
16018289|NCT02751203|Behavioral|Make Safe Happen App|The Make Safe Happen app is a mobile app (available for free download android and iOS) developed by the safety experts in the Center for Injury Research and Policy. Parents and caregivers can use the app to learn how to make their homes safer with room-to-room safety checklists and links to recommended products. App users can also create to-do lists, set reminders and track their progress.
16018290|NCT02751190|Procedure|Totally ExtraPeritoneal (TEP) repair|
16018291|NCT02751190|Procedure|TransAbdominal PrePeritoneal (TAPP) repair|
16018292|NCT02751190|Procedure|Open anterior mesh repair|
16018293|NCT02751190|Procedure|Open Anterior Non Mesh|
16018294|NCT02751190|Procedure|Combined anterior and posterior repair|
16018295|NCT02751190|Procedure|Open preperitoneal mesh repair|
16018296|NCT02751177|Genetic|KRAS, NRAS et BRAF mutation analysis from circulating plasma DNA|Mutation in plasma DNA vs tumor tissue
16018297|NCT02751164|Other|Day/time of admission to the critical care unit|
16018298|NCT02751151|Other|have Levulan Kerastick (aminolevulinic acid) solution|Levulan Kerastick (aminolevulinic acid) solution applied to the face and/or scalp (if both are needed, treated separately on back to back days); with an incubation period of 2.5 hours. Blue light photodynamic therapy utilizing the DUSA BLU-U device, illumination: 1000 seconds (16 min, 40 secs), will be administered
16018299|NCT02751138|Procedure|Surgery|Tumor resection
16018300|NCT02751125|Drug|BCP with autologous mesenchymal stem cells (MSC).|Augmentation of narrow alveolar ridge with BCP and MSC
16018301|NCT02751112|Biological|Predictor' kit|Realization of the Predictor' kit on the blood of donor of HSC, in the frame of a graft, to predict a aGvH reaction on recipient patient.
16018302|NCT02751099|Other|transplanted patients|bone biopsy, echocardiogram, blood samples
16018303|NCT02751086|Procedure|Robotic Gastrectomy|Minimally invasive surgical approach, related to the availability of a robotic surgical system (eg Da Vinci surgical system), that allows a surgeon to perform surgery through a console and dedicated devices.
16018304|NCT02751086|Procedure|Laparoscopic Gastrectomy|Minimally invasive surgical approach performed through traditional laparoscopy.
16018305|NCT02751060|Other|No intervention|
16018306|NCT02751047|Other|manual ventilation|Facemask ventilation is performed by manual bagging with reservoir bag.
16018307|NCT02751047|Other|Pressure controlled mechanical ventilation|Facemask ventilation is performed with mechanical ventilator by pressure controlled mode.
16018308|NCT02751034|Device|Neuramis® Deep Lidocaine|HA filler
16018309|NCT02751034|Device|Restylane® PERLANE-L|HA filler
16018310|NCT02751021|Other|pacemaker diagnostic algorithm|evaluation of the respiratory disturbance index by measurement of transthoracic impedance variation, to detect sleep apnea
16018311|NCT02751021|Other|Attended cardiorespiratory sleep study|sleep study with portable monitor resulting in the apnea hypopnea index, to confirm sleep apnea diagnosis
16018312|NCT02750995|Biological|NPMW-peptide vaccine|Peptide vaccine against long peptide sequences from NY-ESO-1, PRAME, MAGE-A3, WT-1.
16018313|NCT02750995|Drug|Azacitidine|Standard therapy. All participants receive azacitidine 6 months prior to inclusion, which continues during the study period.
16018314|NCT02750982|Other|Laughter Therapy|Laughter Therapy (LT) involves simple exercises using playfulness, eye contact and chanting in forms of laughter. LT will be taught by a certified LT instructor in a group session. There will be 8 sessions per group with each session attended by 8-12 participants and lasting 60 minutes
16018315|NCT02750969|Device|Lidoderm patch (Lidocaine 5% patch)|"The investigator will attach the patches on the patient's back for 12 consecutive hours.
~tinnitus questionnaires will be fulfilled by the patient before and after the patches usage . blood test for serum lidocaine level will be measured after the usage of this patch"
16018316|NCT02750969|Other|Tegaderm patch. (neutral patch, containing no drug)|"The investigator will attach the patches on the patient's back for 12 consecutive hours.
~tinnitus questionnaires will be fulfilled by the patient before and after the patches usage . blood test for serum lidocaine level will be measured after the usage of this patch"
16018355|NCT02750670|Drug|Dexamethasone|Corticosteroid
16018356|NCT02750670|Drug|Cisplatin|Antineoplastic Agent
16018357|NCT02750657|Genetic|Molecular Profiling|Whole Genome Sequencing
16018405|NCT02750293|Drug|Cholecalciferol|Vitamin D preparation
16018406|NCT02750293|Drug|Placebo|placebo
16018317|NCT02750969|Procedure|blood test- serum lidocain levels|"each participant will undergo blood test. the participant's group that start the trial with the lidoderm patch and later will use the tegaderm patch will have 2 blood tests for werum lidocain level test. the group taht start the trial with the tegaderm patch and later the lidoderm patch will have only one blood test measuring lidocaine serum level.
~the tubes containing the serum will be shipped abroad via an international medical cargo company for lidocaine levels tests."
16018318|NCT02750969|Other|Hearing tests|each participant that have not done hearing test in the last 1 year previous to the trial will have one in the first day of the trial.
16018319|NCT02750956|Procedure|Non-surgical periodontal treatment|Non-surgical periodontal therapy is an anti-infective therapy which includes both mechanical and chemotherapeutic approaches to minimize or eliminate microbial biofilm, the primary etiology of gingivitis and periodontitis
16018320|NCT02750943|Drug|Stannous Fluoride|Dentifrice containing 0.454% w/w stannous fluoride
16018321|NCT02750943|Drug|Sodium Monofluorophosphate|Dentifrice containing 1000ppm fluoride as sodium monofluorophosphate
16018322|NCT02750930|Drug|Albiglutide|Albiglutide liquid drug product is provided as a fixed-dose, disposable auto-injector containing albiglutide liquid drug product (50 mg). Subjects will receive albiglutide 50 mg through subcutaneous injection in the abdomen, thigh or upper arm region via auto-injector. Albiglutide is a glucagon-like peptide-1 agonist (GLP-1 agonist).
16018323|NCT02750930|Device|Auto-injector|The auto-injector delivers the albiglutide liquid drug product in an injection volume of 1.0 mL for the 50 mg dose.
16018324|NCT02750917|Drug|Lornoxicam|At the end of surgery patients in group LORNOXICAM received one pill of 8 mg lornoxicam every 12 hours in the surgery day and first postoperative day.
16018325|NCT02750917|Drug|Etoricoxib|At the end of surgery patients in the ETORICOXIB group received one pill of 120 mg etoricoxib at the end of surgery and a second one after 24 hours. This group also received placebo pills at 12 h, between the active pills.
16018326|NCT02750904|Behavioral|Experimental plus Nicotine Replacement Therapy|"Behavioral: Experimental plus Nicotine Replacement Therapy will be built to specifically address challenges of smoking cessation for individuals with bipolar disorder.
~Includes four in person and four phone visits.
~Therapy information is withheld to protect the integrity of the study."
16018327|NCT02750904|Behavioral|Control plus Nicotine Replacement Therapy|Includes four in-person and four phone visits
16018328|NCT02750891|Drug|DSP-7888|Phase1 portion: 1.75 or 3.5 mg/body, Id every 1-4 weeks Phase 2 portion: recommended phase 2 dose, Id every 1-4 weeks
16018329|NCT02750878|Other|Informational Handout|
16018331|NCT02750852|Procedure|Total hip arthroplasty, blood loss analysis|Data analysis about blood loss in total hip replacement
16018332|NCT02750839|Procedure|proximal humerus fracture fixation|Mini-invasive proximal humerus fixation with plate, patient in beach chair position, general anesthesia, a small incision lateral to shoulder is made to insert the plate under scope control
16018333|NCT02750826|Other|Health Education Program|
16018334|NCT02750826|Other|Weight Loss Intervention|
16018335|NCT02750813|Device|Delefilcon A contact lenses|
16018336|NCT02750813|Device|Senofilcon A contact lenses|
16018337|NCT02750800|Biological|Adalimumab|Pre-filled syringe or pen, administered by subcutaneous injection
16018338|NCT02750800|Behavioral|AbbVie Care 2.0|Supportive services provided to participants included reminder calls, emails, text messages, nursing services, dietician, and psychological support. An adalimumab starter pack, injection guide, digital and print educational materials were also provided.
16018339|NCT02750787|Other|Nutritional Study Product|Two 220 ml servings per day
16018340|NCT02750774|Behavioral|Low-glycemic index group|"The dietary intervention consisted of the prescription of a Mediterranean style, low-glycaemic, low-fat, exchange diet (3 main meals and 3 snacks) with a total intake of 1500 kcal/day. In light of the PA, the dietitian adds 200 kcal/day for obese, 300 kcal/day for overweight women. The diet had a target macronutrient composition of 55% carbohydrates (80% complex carbohydrates with a low glycaemic index and 20% simple carbohydrates), 20% protein (50% animal and 50% vegetable) and 25% fat (12% mono-unsaturated, 7% polyunsaturated and 6% saturated) with moderately low saturated fat levels. The daily intake of carbohydrates was at least 225 g/day. The exercise intervention was focused on developing a more active lifestyle. The PA prescription is consistent with recommendations by the ACOG and ACSM for pregnant women. The talk test (being able to maintain a conversation during activity) was suggested to monitor the exercise intensity."
16018341|NCT02750774|Other|Standard Care Group|Women randomized to the Standard Care Group received general information about healthy lifestyle during pregnancy, according to the Guidelines
16018342|NCT02750761|Drug|Tedizolid Phosphate (IV)|200 mg/vial powder for injection
16018343|NCT02750761|Drug|Tedizolid Phosphate (oral suspension)|Powder for oral suspension 20 mg/mL following reconstitution
16018344|NCT02750748|Drug|Naltrexone|
16018345|NCT02750748|Other|Intravail|
16018346|NCT02750722|Device|Flutter®|Acute exercise with Flutter® breathing therapy.
16018347|NCT02750722|Device|No Flutter®|Acute exercise without Flutter® breathing therapy.
16018348|NCT02750709|Drug|Nitisinone|A single oral dose of Nitisinone 10 mg tablet will be administered in fasted state.
16018349|NCT02750709|Drug|Nitisinone 10 mg Tablet High Compritol|A single oral dose of Nitisinone 10 mg High Compritol tablet will be administered in fasted state.
16018350|NCT02750709|Drug|Orfadin|A single oral dose of Orfadin 10 mg hard capsule will be administered in fasted state.
16018351|NCT02750696|Drug|Fixed-dose oral tablet of codeine/ acetaminophen every 4 hours for 3 days|Patients in this group received opioid/ non-opioid analgesic combination.
16018352|NCT02750696|Drug|Fixed-dose oral tablet of tramadol/ acetaminophen every 4 hours for 3 days|Patients in this group received opioid/ non-opioid analgesic combination.
16018353|NCT02750670|Drug|Obinutuzumab|Type II anti-CD20 monoclonal antibody
16018354|NCT02750670|Drug|Gemcitabine|Antineoplastic agent
16018358|NCT02750631|Other|Triple Therapy|The intervention consists of three interventions: missing a night of sleep, early morning bright lights and sleep phase advance
16018359|NCT02750618|Biological|Burosumab|solution for subcutaneous injection
16018362|NCT02750592|Drug|Secukinumab 150 mg provided in 1.0 mL pre-filled syringes (PFSs) for sc injection.|Baseline, 1, 2, 3, 4 week. After 4 week, administered every 4 weeks.
16018363|NCT02750579|Procedure|Percutaneous coronary intervention for revascularization|Percutaneous coronary intervention for revascularization with anticoagulant and antiplatelet therapy (routine care)
16018364|NCT02750566|Procedure|Osteopathic Manipulative Treatment|Manual treatment of musculoskeletal restrictions that may be prevent proper healing post-concussion.
16018365|NCT02750566|Other|Counseling|Patients will be counseled on concussion awareness, symptoms, and treatment for 30 minutes by a physician.
16018366|NCT02750553|Drug|SHR0534|
16018367|NCT02750553|Drug|Placebo|
16018368|NCT02750540|Drug|Tenofovir enema|
16018369|NCT02750540|Other|Saline enema|
16018370|NCT02750514|Biological|Nivolumab|Arm associated with this intervention is closed. Nivolumab is no longer given as an active comparator.
16018371|NCT02750514|Drug|Dasatinib|
16018372|NCT02750514|Biological|Relatlimab|
16018373|NCT02750514|Biological|Ipilimumab|
16018374|NCT02750514|Drug|BMS-986205|Specified dose on specified days
16018375|NCT02750501|Device|RELiZORB (immobilized lipase) cartridge|Hydrolyzing fats from enteral formula, ex vivo, with in-line enteral feed RELiZORB (immobilized lipase) cartridge
16018376|NCT02750501|Other|Impact Peptide 1.5|Impact Peptide 1.5 at a volume of administration from 500 mL to 1,000 mL per enteral feeding
16018377|NCT02750488|Drug|BAY987517|50 μl/ cm2 of the test article is applied directly to two sites on the skin and covered with the appropriate patch. Twenty-four (24) hours later, the patches are removed. The test sites are lightly wiped with a dry cloth/tissue and 3μl/ cm2 of test article is reapplied directly to the skin of the test site designated for irradiation, and lightly spread over the test site. Forty-eight (48) hours later the procedure is repeated to the same test sites. This process is repeated twice weekly for a total of six exposures.
16018378|NCT02750488|Other|Untreated skin|One site is patched without treatment as control
16018379|NCT02750475|Drug|Sunscreen Sport Lotion (BAY987516)|50 μl/cm*2 or 0.05 gm/cm*2 of each test product is applied to duplicate skin sites (approximately 2 x 2 cm each). After the test articles have dried for 5 to 15 min, the sites are covered by the appropriate patch.24 hours later, the set of patches covering the product are removed. Three (3) μl/ cm2 or 0.003 gm/cm*2 of the test product is reapplied to the test site, air dried for 5 to 15 minutes for volatilization and then the test site is exposed to UVA radiation.(Formulation number - RB# Y65-110)
16018380|NCT02750475|Other|Untreated Skin|This site is patched without treatment as irradiated control
16018381|NCT02750462|Other|Immediate coronary angiography|Immediate coronary angiography in survivors of out-of-hospital cardiac arrest without ST-segment elevation
16018382|NCT02750462|Other|Delayed/selective coronary angiography|Initial intensive care evaluation to further stratify the etiology of out-of-hospital cardiac arrest with delayed/selective coronary angiography if indicated
16018383|NCT02750449|Drug|Sun screening Sport Lotion, (BAY987516)|50 μl/ cm*2 of the test article is applied directly to two sites on the skin and covered with the appropriate patch. 24 hours later, the patches are removed. The test sites are lightly wiped with a dry cloth/tissue and 3 μl/ cm*2 of test article is reapplied directly to the skin of the test site designated for irradiation, and lightly spread over the test site. 48 hours later the procedure is repeated to the same test sites. This process is repeated twice weekly for a total of six exposures. (Formulation Number - RB# Y65-110)
16018384|NCT02750449|Other|Untreated skin|This site is patched without treatment as control
16018385|NCT02750436|Device|Ultrasound guided|This group will be treated using an ultrasound imaging device
16018386|NCT02750436|Device|Fluoroscopy guided|This group will be treated using a fluoroscopy imaging device
16018387|NCT02750423|Procedure|DHCA+RCP|During deep hypothermic circulatory arrest and retrograde cerebral perfusion (DHCA+RCP) the participant is placed on cardiopulmonary bypass (heart-lung machine) and their body temperature is lowered to a range of 14-18 °C. Once the goal temperature has been achieved, the circulation is stopped and aortic arch replacement is performed in a bloodless surgical field. Blood will be pushed to the brain through arterial vessels, much like the natural blood flow pattern. Once the aortic arch repair is complete, cardiopulmonary bypass is reinstituted, the participant is rewarmed, and separated from cardiopulmonary bypass.
16018388|NCT02750423|Procedure|MHCA + SACP|During moderate hypothermic circulatory arrest and unilateral selective antegrade cerebral perfusion (MHCA + SACP) the participant is placed on cardiopulmonary bypass (heart-lung machine0 and the native blood flow to the brain is temporarily suspended. The body is cooled to temperatures of ≤28°C and blood is administered to the brain via an artery in the neck during the period of arch reconstruction. Once the aortic arch repair is complete, cardiopulmonary bypass is reinstituted, the participant is rewarmed, and separated from cardiopulmonary bypass.
16018389|NCT02750410|Drug|Dulaglutide|Administered subcutaneously (SC)
16018390|NCT02750410|Drug|Placebo|Administered SC
16018391|NCT02750384|Drug|DSM265 50% SDD granules|Single oral dose 400 mg
16018392|NCT02750384|Drug|DSM265 25% SDD powder for suspension|Single oral dose 400 mg
16018393|NCT02750371|Other|Evaluation of autobiographical memory|Patients will answer several questionnaires one and two years after irradiation treatment end.
16018394|NCT02750358|Drug|Enzalutamide|
16018395|NCT02750358|Behavioral|assessment|
16018396|NCT02750345|Drug|Nitisinone|A single oral dose of Nitisinone 10 mg Tablet will be administered.
16018397|NCT02750345|Drug|Nitisinone Baked Tablet|A single oral dose of Nitisinone 10 mg Tablet (6 months @ 40°C/75% RH) will be administered.
16018398|NCT02750345|Drug|Orfadin|A single oral dose of Orfadin 10 mg hard capsule will be administered.
16018399|NCT02750332|Drug|Nitisinone|A single oral dose of Nitisinone 10 mg Tablet will be administered.
16018400|NCT02750319|Drug|Amiodarone|
16018401|NCT02750319|Drug|N-Acetylcysteine|
16018402|NCT02750319|Drug|Placebo|
16018407|NCT02750280|Device|MatriStem® [Urinary Bladder Matrix (UBM)]|Porcine derived urinary bladder extracellular matrix
16018408|NCT02750280|Device|Mepilex® [Silicone foam dressing]|primary wound dressing
16018409|NCT02750267|Device|Diabetes Assistant (DiAs) with Closed-Loop|All subjects will use DiAs Medical Platform, a study insulin pump and continuous glucose monitor (CGM) in closed-loop mode during a Research House/Hotel admission that will last up to 72 hours.
16018410|NCT02750254|Drug|Fludarabine|
16018411|NCT02750254|Radiation|Fractionated total body irradiation|
16018412|NCT02750254|Drug|Busulfan|
16018413|NCT02750254|Drug|Cyclophosphamide|
16018414|NCT02750254|Radiation|Single dose total body irradiation|
16018415|NCT02750254|Drug|Melphalan|
16018416|NCT02750254|Drug|Granulocyte-colony stimulating factor|
16018417|NCT02750254|Procedure|Stem cell transplant|
16018418|NCT02750254|Drug|Azacitidine|
16018419|NCT02750241|Behavioral|Active video game-based intervention|"Attend 12 weekly group session at the UTMB Breast Health Clinic to play the active video games using Wii Fit U or Xbox 360.
~Participate in self-paced home sessions
~Monitor daily, weekly, and monthly steps using Wii Fit Meter
~Feedback on physical activity and physical function"
16018420|NCT02750241|Behavioral|Pedometer|"Attend 3 monthly UTMB Breast Cancer Support Group Sessions
~Monitor daily, weekly, and monthly steps using a pedometer (Digi-walker CW-700/701)
~Feedback on physical activity and physical function"
16018421|NCT02750215|Drug|Capmatinib (INC280)|treatment with Capmatinib (INC280)
16018422|NCT02750202|Biological|Quadrivalent HPV vaccine|Quadrivalent HPV vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.
16018423|NCT02750202|Biological|Hepatitis B vaccine|Hepatitis B vaccine doses administered intramuscular as 3 separate 0.5 ml doses at month 0, month 2 and month 6.
16018424|NCT02750189|Other|Direct cost|Money spent to treat COPD in medical institute based on HIRA
16018425|NCT02750189|Other|Indirect cost|extra-expanses excluding hospital fees
16018426|NCT02750176|Other|Closed chain exercises|Closed-chain strengthening will be performed with the shoulder moving over a fixed hand. Resistance will be provided by body weight against gravity. To off-load and progress the amount of body-weight resistance, elastic bands will be used to support body weight using a exercise frame. Patients will perform 6 exercises.
16018427|NCT02750163|Drug|paracetamol|Paracetamol will be given to febrile septic patients
16018428|NCT02750150|Drug|Freezed-dried plasma|early transfusion of 4 units of freezed dried plasma
16018429|NCT02750150|Drug|Fresh-frozen plasma|
16018430|NCT02750137|Drug|Tetracaine|Application of Ametop prior to intravenous cannulation
16018431|NCT02750124|Device|Cobas PCR Female swab sample Packet|The cobas® PCR Female Swab Sample Kit is used to collect and transport vaginal swab specimens self-collected.
16018432|NCT02750124|Other|Routine practice|The standard, annual renewed invitation to cervical screening.
16018433|NCT02750098|Other|Glucose measurement|"Elective cataract surgery
~Blood glucose measurement - glucometer
~Aqueous humor glucose measurement - at beginning of cataract surgery - glucometer
~Perioperative Hemoglobin A1c level - blood laboratory test"
16018434|NCT02750072|Procedure|Infrapatellar Approach|Infrapatellar approach using the surgeon's incision of choice (i.e. patellar tendon split, tendon retraction medial, tendon retraction lateral)
16018435|NCT02750072|Procedure|Suprapatellar Approach|Semi-extended suprapatellar approach using quadriceps split combined with purpose designed percutaneous instrumentation
16018436|NCT02750059|Drug|TDF/3TC/EFV + Telmisartan|The subject will receive 40mg telmisartan daily for 4 weeks followed by 80mg telmisartan daily for 44 weeks in addition to ART. Subjects unable to tolerate 80mg of telmisartan will be able to de-escalate to 40mg daily
16018437|NCT02750059|Drug|TDF/3TC/EFV only|Starting from the first visit, all participants will be placed on an ART regimen to treat HIV. This is the standard route of care for HIV patients.
16018438|NCT02750046|Procedure|total hip arthroplasty or proximal femoral nails|Bone samples from Hip fracture were collected when total hip arthroplasty or proximal femoral nails was performed.
16018439|NCT02750033|Device|Multimodal Spectroscopy (MMS)|surgical margin assessment with multimodal optical spectroscopy (MMS) device
16018440|NCT02750020|Other|Questionnaire|Current study is a retrospective telephone survey based on questionnaires. It aims to investigate the level of public support on current and future tobacco control measures and taxation policies and to address the timely impacts of smoke-free policies, substantiate public support on further tobacco control measures and assist COSH in shaping policy direction for government. The telephone survey will be conducted by a telephone survey agent under the monitor of applicants.
16018441|NCT02750007|Drug|HS-20004|
16018442|NCT02749994|Drug|Rosuvastatin|
16018443|NCT02749994|Drug|Ezetimibe|
16018444|NCT02749981|Procedure|blood and tissue sampling|
16018445|NCT02749968|Drug|Liposomal bupivacaine|1 mL of liposomal bupivacaine injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position
16018446|NCT02749968|Drug|0.9% sodium chloride|1 mL of 0.9% saline injected with a 25-G needle just below each affected rib by the intercostal neurovascular bundle in a paraspinal position
16018447|NCT02749955|Behavioral|PS-PrEP Intervention Group|This group will involve working with a PS-PrEP social worker to learn about PrEP. The PS-PrEP social worker will help subjects develop a care plan based on the subject's decision about whether or not to use PrEP. This may include referrals for PrEP, other services, and/or HIV testing. Personal contact will continue by way of phone calls, and messages in between visits.
16018448|NCT02749955|Behavioral|PrEPLine Control Group|This group follows routine department of public health care as a Linkage to Care Specialist from the PrEPLine provides subjects with PrEP education and the ability to schedule an initial PrEP appointment. In addition to this care, subjects will be referred for additional testing for STIs/HIV and subjects will be given information about programs available to prevent HIV infection, which include PrEP.
16018449|NCT02749942|Device|AutoRIC: Remote Ischemic Conditioning|"4 cycles of 5 minute forearm ischemia/reperfusion (200 mmHG) using the reusable fully automated RIC device AutoRIC from CellAegis Devices, Canada"
16018450|NCT02749942|Device|AutoRIC: Sham device treatment|"4 cycles of 5 minute forearm sham treatment (no ischemia/reperfusion, 0 mmHG pressure) with the reusable fully automated RIC device AutoRIC from CellAegis Devices, Canada"
16018451|NCT02749929|Other|Low level laser therapy|The laser is an infrared (invisible) 60 mW 904 nm Irradia Midlaser
16018452|NCT02749929|Other|Placebo Low Level Laser Therapy|The placebo laser is an identical device to the active laser, made by Irradia Midlaser
16018453|NCT02749916|Other|Methods of carotid wall imaging|
16018455|NCT02749890|Drug|Insulin glargine/Lixisenatide (HOE901/AVE0010)|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
16018456|NCT02749890|Drug|Lixisenatide (AVE0010)|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
16018457|NCT02749890|Drug|Oral anti-diabetic drugs|"Pharmaceutical form: tablet
~Route of administration: Oral"
16018458|NCT02749877|Behavioral|Working Memory Training|(Training Details already described above)
16018459|NCT02749877|Behavioral|Physical Training|(Training Details already described above)
16018460|NCT02749851|Device|MRI|Recently-developed placenta-specific magnetic resonance imaging (MRI) tools will be used to quantify maternal perfusion and oxygen transfer throughout pregnancy in 3 groups of human subjects: 1) non-smokers, 2) smokers, 3) individuals at high risk for adverse outcome. The objective of this work is to develop a new non-invasive clinical tool for early identification of placental dysfunction.
16018461|NCT02749851|Device|MRI - IUGR|Recently-developed placenta-specific magnetic resonance imaging (MRI) tools will be used to quantify maternal perfusion and oxygen transfer throughout pregnancy. The objective of this ancillary arm is to further test the sensitivity of placental magnetic resonance imaging to detect abnormal perfusion and oxygenation in confirmed cases of IUGR between gestational ages 28 to 36 weeks.
16018462|NCT02749825|Drug|Trelstar|As labeled
16018463|NCT02749825|Drug|Lupron|As labeled
16018464|NCT02749825|Drug|Zoladex|As labeled
16018465|NCT02749812|Device|Constant Continuous Positive Airway Pressure|
16018466|NCT02749812|Device|Automatic continuous Positive Airway Pressure|
16018467|NCT02749799|Drug|DFD-01 (betamethasone dipropionate) Spray, 0.05%|DFD-01 (betamethasone dipropionate) Spray, 0.05% to be applied twice daily on the affected areas (avoiding the face, scalp, groin, axillae and other intertriginous areas) for 28 days.
16018468|NCT02749786|Other|Skin Biopsy|Skin biopsies will be performed via the Keys punch technique from normal facial skin.
16018469|NCT02749773|Device|Oocyte Aspiration needle|Oocyte aspiration in women go through an IVF procedure,.
16018470|NCT02749760|Other|Strengthening program|Strengthening programs may be established to target the stabilizers of the elbows
16018471|NCT02749760|Other|Exercise program|Exercise program may be established to target the stabilizers of the elbows.
16018472|NCT02749747|Drug|Sulpiride use|50mg sulpiride once a day use for 60 days
16018473|NCT02749747|Drug|Placebo|50mg placebo once a day use for 60 days
16018474|NCT02749734|Procedure|Subretinal transplantation|Transplant hESC-RPE into subretinal space of patients with macular degeneration
16018475|NCT02749721|Drug|vortioxetine|Open-label vortioxetine
16018476|NCT02749708|Drug|IRX5183|IRX5183 will be administered orally daily on days 1-28 of each cycle for 2 cycles of induction. In the phase I part of the study, there will be 3 dose levels (dose level 1 [DL1] with 50 mg, DL2 with 75 mg, and DL3 with 100 mg), with 1 additional dose level to be only used if excessive toxicity noted at the DL1. There will be no intra-patient dose escalation. A phase II portion of the study was originally planned, but the study was terminated prior to phase II enrollment.
16018477|NCT02749695|Drug|Melsmon|Placental extract Melsmon® (Japan): 2 ml (100 mg), subcutaneously, every 2nd day for 2 weeks, then twice a week (30 injections for 4 months in total).
16018478|NCT02749695|Other|Placebo|2 ml subcutaneously, every 2nd day for 2 weeks, then twice a week (30 injections for 4 months in total).
16018479|NCT02749669|Other|Qualitative research|Semi-structured Interviews
16018480|NCT02749656|Drug|0.25% Desoximetasone cream (Topoxy®)|apply on the scalp psoriasis lesion twice a day
16018481|NCT02749656|Drug|0.25% Desoximetasone cream (Topicorte®)|apply on the scalp psoriasis lesion twice a day
16018482|NCT02749656|Drug|Placebo|apply on the scalp psoriasis lesion twice a day
16018483|NCT02749643|Device|Vibrotactile feedback system|
16018484|NCT02749630|Drug|Placebo|Matching placebo to UTTR1147A administered intravenously
16018485|NCT02749630|Drug|UTTR1147A|Escalating doses of intravenously administered UTTR1147A
16018486|NCT02749617|Drug|apixaban|2.5 mg PO BID
16018487|NCT02749604|Procedure|Non-ejaculatory sparring PVP|Greenlight laser photoslective vaporization of the prostate
16018488|NCT02749604|Procedure|Ejaculatory sparring PVP|Greenlight laser photoslective vaporization of the prostate with preservation of the ejaculatory hood
16018489|NCT02749591|Drug|Botulinum Toxin Type A|To inject Botulinum toxin type A on the spasticity upper extremity for stroke patients.Doses and muscles selected for BoNT-A injection are individualized on the basis of a number of factors, including the spasticity patterns, severity of spasticity, and treatment goals
16018490|NCT02749591|Other|Robot-assisted therapy|After injecting Botulinum toxin type A on the spasticity upper extremity, the RT group will receive a 45 minutes of robotic training and 30 minutes of training in functional training.
16018491|NCT02749591|Other|Mirror therapy|After injecting Botulinum toxin type A on the spasticity upper extremity, the MT group will receive a 45-minute MT per session followed by 30 minutes of task-oriented functional training.
16018492|NCT02749591|Other|Control intervention|After injecting Botulinum toxin type A on the spasticity upper extremity, the CI group will receive 75-minute rehabilitation program, focusing on upper extremity training and including neurodevelopmental techniques, trunk-arm control, weight bearing by the affected arm, fine motor tasks practice, functional task practice, and practice on compensatory strategies for daily activities.
16018493|NCT02749578|Drug|Atorvastatin|
16018494|NCT02749578|Drug|MGL-3196|
16018495|NCT02749552|Behavioral|Acceptance and Commitment Therapy|weight-related interventions using values, acceptance, and mindfulness based on Acceptance and Commitment Therapy
16018496|NCT02749539|Device|Kinesio tape|Standard 2 -inches ( 5-m) Kinesio TexR tape was used for application in the experimental group
16018497|NCT02749539|Procedure|physiotherapy program|active-assistive range of motion exercises (AAROME), active stretching exercises and strengthening exercises for the shoulder joint. Likewise, patients also received postural correction exercises
16018498|NCT02749526|Drug|"Endostar"|30mg civ24h d0-6.A course of 3 weeks, after two course of chemotherapy the CT/MR/ultrasonic gastroscopy.
16018499|NCT02749526|Drug|Liposo|135mg/m2 D1.A course of 3 weeks, after two course of chemotherapy the CT/MR/ultrasonic gastroscopy.
16018500|NCT02749526|Drug|cisplatin|25mg/m2 D1-3.A course of 3 weeks, after two course of chemotherapy the CT/MR/ultrasonic gastroscopy.
16018501|NCT02749526|Drug|Gimeracil and Oteracil Potassium （Tegafur）|40mg bid，D1-14.A course of 3 weeks, after two course of chemotherapy the CT/MR/ultrasonic gastroscopy.
16018502|NCT02749513|Drug|Itraconazole|
16018503|NCT02749500|Other|Conventional Occupational Therapy (OT)|Standard of care occupational therapy for stroke recovery
16018504|NCT02749500|Device|m2 BAT|Conventional OT plus 1 hour additional bimanual-to-unimanual device-assisted therapy.
16018505|NCT02749487|Other|Neutrophil Lymphocyte Ratio|Neutrophil:lymphocyte ratio (NLR) is an emerging biomarker that is used to predict mortality and morbidity. The association of this biomarker with systemic illness and its usefulness in risk assessment of critically ill patients has not been fully elucidated.
16018506|NCT02749461|Procedure|heel stick|Consecutive routine blood sampling heel sticks
16018507|NCT02749448|Other|mesenchymal stem cell|There are complex sets of non-hematopoietic cells in bone marrow called mesenchymal progenitor cells (MPCs). MSCs are well-known as multipotent cells that have the ability to self-renew and differentiate into a great variety of cells. MSCs can be isolated from bone marrow, umbilical cord, peripheral blood and adipose tissue, and cultured in specific media. MSC colony formation, which is known as marrow-like stromal cells and MPCs, is similar to fibroblast colony forming unit (CFU-F) in in vitro condition. According to the International Society for Cellular Therapy (ISCT), MSCs can be easily detected or identified from other cells using flow cytometric analysis to detect specific surface markers
16018508|NCT02749435|Other|Use of digital disease management tool in participants with T2DM|The purpose of this study is to evaluate if the provision of a digital disease management tool in addition to standard care for T2DM, will improve glycaemic control. The impact of the tool will be assessed in comparison to a Control group who will receive standard care alone. All participants will complete the PRO assessments. This is a real-world study carried out at the point of care intended to assist health care practitioners and managed care providers to make evidence-based decisions about how to improve participant self-management of their diabetes.
16018509|NCT02749422|Diagnostic Test|MagStim RapidStim2|Repetitive transcranial magnetic stimulation (TMS)
16018510|NCT02749409|Drug|Parecoxib|
16018511|NCT02749409|Drug|Morphine|
16018512|NCT02749396|Drug|Betaseron (Interferon beta-1b, BAY86-5046), Bayer HealthCare AG|Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
16018513|NCT02749396|Drug|Extavia (interferon beta-1b), Novartis Pharma AG|Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
16018514|NCT02749396|Drug|Rebif (interferon beta-1a), Merck Serono Europe Ltd|Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
16018515|NCT02749396|Drug|Plegridy (peginterferon beta-1a), Biogen Idec Ltd|Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
16018516|NCT02749396|Drug|Avonex (interferon beta-1a), Biogen Idec Ltd|Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
16018517|NCT02749396|Drug|MSDMDs other than Betaseron (Interferon beta-1b, BAY86-5046)|Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
16018518|NCT02749396|Other|No MSDMDs therapy (control)|Information will be obtained from the databses DPP (FIN) and MBR (SWE, NOR)
16018519|NCT02749383|Drug|PAC-14028 cream 0.3%|Topical application
16018520|NCT02749383|Drug|PAC-14028 cream 1.0%|Topical application
16018521|NCT02749383|Drug|PAC-14028 cream vehicle|Topical application
16018522|NCT02749370|Drug|Etanercept|Administered subcutaneously twice weekly for 12 weeks then once weekly for an additional 12 weeks.
16018523|NCT02749357|Device|30 minutes Lokomat|"30 training sessions in robotic orthosis with duration of 30 or 60 minutes during 6 weeks, duration of 30 minutes.
~The initial training speed will be the comfortable one for each patient, as assessed by Swinnen (20). The training progression will consist in a 10% weekly increase in speed, and a 5% weekly reduction of partial weight support."
16018524|NCT02749357|Device|60 minutes Lokomat|30 training sessions in robotic orthosis with duration of 30 or 60 minutes during 6 weeks, duration of 60 minutes.
16018525|NCT02749344|Other|FET after endometrial preparation|Patients included in the protocol will begin progesterone supplementation 48 hours before scheduled embryo transfer once it has been established that the endometrium is at least 7 mm and there is a leading follicle.
16018526|NCT02749331|Drug|AdVince|Virus solution for infusion in intrahepatic artery
16018527|NCT02749318|Genetic|IL-1 genetic test for risk of severe periodontitis|DNA obtained by cheek swab analyzed for four variations (SNPs) in the IL-1beta gene to determine whether patient is at elevated risk for more severe periodontal disease.
16018528|NCT02749305|Other|Collection of patient-reported outcome measures|Preoperative and postoperative metabolic and bariatric surgery patients will be asked to electronically complete a set of PROMs up to 21 days before surgery and annually on their surgical anniversary they will be asked to complete a postoperative PROM.
16018529|NCT02749292|Drug|Rituximab|re-dosing dependent on interventional arm parameter.
16018530|NCT02749266|Other|Chiropractic adjustment|Participant will receive a chiropractic adjustment utilizing a handheld chiropractic instrument called an Activator.
16018531|NCT02749266|Other|Sham chiropractic adjustment|Participants will receive a simulated chiropractic adjustment with a handheld adjusting instrument called an Activator.
16018532|NCT02749253|Other|Sudarshan Kriya Yoga Tauma Relief Program (SKY).|Sudarshan Kriya Yoga Trauma Relief Program (SKY) participants will undergo a 12-week training course in SKY conducted by certified instructors from the Art of Living Foundation
16018533|NCT02749240|Other|Youth Empowerment Seminar, YES!|An 8-week innovative bio-psycho-social program.
16018534|NCT02749227|Drug|Pasireotide LAR|"Pasireotide LAR (SIGNIFOR® LAR) is a somatostatin analog indicated for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. It is a long acting release injectable suspension for intramuscular use.
~The starting dose is Pasireotide LAR 40 mg/month intramuscular (IM), this will be increased to 60 mg/month at 6 months if a fall in POMC levels and/or tumor shrinkage are not attained."
16089247|NCT02242344|Drug|Placebo|
16018535|NCT02749214|Other|Blood Sample Collection|Participants will have two to three tablespoons (30 cc) of peripheral blood drawn to test for inflammatory markers.
16018536|NCT02749214|Other|Breath Sample Collection|Participants will be asked to breathe into the Breath Sampler containing a rapid passive volatile organic compounds (VOC) sampling device. A disposable mouthpiece is placed over a portion of the sampler where the participant placed his/her mouth. The mouthpiece will be disposed of after each use and a new one will be used for each participant. Prior to sample collection, the participant will be asked to rinse his/her mouth with water. Then the participant will breathe deeply into the sampler five times with breaths being five minutes apart to collect the alveolar breath.
16018537|NCT02749201|Device|Gastrisail|Light Intensity and gastric wall thickness assessment
16018538|NCT02749188|Other|Bladder stimulation|Bladder stimulation as a noninvasive technique of urine collection. The renal and bladder stimulation will be performed in less than 3 minutes, with a maximum of two attempts spaced about 20 minutes
16018539|NCT02749175|Device|Cricoid force sensor monitor system|Comprise of a sensor and a monitor system
16018540|NCT02749175|Device|Sham Cricoid force sensor monitor system|Comprise of a sensor and a sham monitor system
16018541|NCT02749162|Drug|Dexamethasone phosphate|At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation
16018542|NCT02749162|Drug|Paracetamol|After the block regression, at the first analgetic request the patients received the analgesia protocol
16018543|NCT02749162|Drug|Morphine|After the block regression, at the first analgetic request the patients received the analgesia protocol
16018544|NCT02749162|Drug|Lidocaine|At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation
16018545|NCT02749162|Drug|Ropivacaine|At the end of surgery the patients received single shot VIB block with the mixture according to the group allocation
16018546|NCT02749136|Drug|Preoperative modified FOLFIRINOX and postoperative gemcitabine|"Preoperative mFOLFIRINOX, every 2 weeks, 8 cycles
~Oxaliplatin IV 85 mg/m2 Day (D) 1
~Irinotecan IV 180 mg/m2 D1
~5-FU continuous IV infusion 2,400 mg/m2 over 46 hours D1-2
~Leucovorin IV 400 mg/m2 D1
~Postoperative gemcitabine, every 4 weeks, 3-6 cycles - Gemcitabine 1,000 mg/ m2 D1, 8, and 15"
16018547|NCT02749123|Drug|lidocaine 5% patch|10cmx 14 cm transdermal patch sealed in its own pouch
16018548|NCT02749123|Drug|lidocaine 3.6%, menthol 1.25%|10cmx 14 cm transdermal patch sealed in its own pouch
16018549|NCT02749123|Drug|Placebo|patch with no active manufactured to have the same look and feel as Lidoderm 10cmx 14 cm transdermal patch sealed in its own pouch
16018550|NCT02749110|Device|Vaginal self-sampling brush|Self-collection by unscreened women aged from 30 to 65 of a vaginal sample with the device. After collection, the whole device is mailed in a normalized for biological samples package to the virology lab of the University Hospital of Lille where a HPV test is conducted using a Cobas 4800 technique.
16018551|NCT02749097|Drug|SHR0534|
16018552|NCT02749097|Drug|Placebo|
16018553|NCT02749084|Biological|T reg DLI|"Purified Treg cells will be obtained from the original HSC donor (T reg DLI).
~Tregs preparation will start with unstimulated donor leukapheresis from the original stem cell donor.
~The apheresis product will be provided to the Cell Factory Calori,Milano, where T reg purification will take place.
~T reg cells will be PURIFIED utilizing the CliniMACS Plus Systems for depletion of CD8 and CD19 positive cells and enrichment for CD25high cells.
~Release Criteria of Treg cell preparation will be defined.
~The product will be infused into the recipient through a venous catheter."
16018554|NCT02749071|Procedure|Laparoscopic implantation surgery|Laparoscopic surgery to implant the pulse generator and bipolar lead.
16018555|NCT02749071|Device|EndoStim stimulation for first six months of study|Lower esophageal stimulation
16018556|NCT02749071|Device|EndoStim stimulation from Month 6 thru end of study|Lower esophageal stimulation
16018557|NCT02749071|Device|Sham EndoStim stimulation for first six months of study|"EndoStim device remains off (no stimulation delivered)"
16018558|NCT02749058|Procedure|Capsulectomy in Direct Anterior Total Hip Arthroplasty|Surgical intervention in which the surgeon will perform anterior capsulectomy during total hip arthroplasty.
16018559|NCT02749058|Procedure|Capsulotomy in Direct Anterior Total Hip Arthroplasty|Surgical intervention in which the surgeon will perform anterior capsulotomy during total hip arthroplasty. Surgeon will repair the joint capsule.
16018560|NCT02749045|Radiation|SPECT imaging|myocardial perfusion imaging
16018561|NCT02749032|Other|Mixed meal test|Mixed meal test were performed in the morning after an overnight fast. The standardized mixed meal was composed of 2 eggs (100 g), 1 slice (50 g) of whole grain rye bread, 1 slice (50 g) of rye flour bread, 10 g of fat-reduced margarine, 20 g of boiled ham, and 25 g of diet jam, amounting to 450 kcal, 50 % carbohydrate, 20 % protein, and 30 % fat (based on calorie count). Patients were allowed to drink tea (black or fruit-based) or de-caffeinated coffee ad libitum.
16018562|NCT02749032|Drug|Vildagliptin|Vildagliptin (50 mg per tablet) was administered orally twice daily (15 minutes prior to breakfast or test meal, on the last day of treatment period) and without a defined temporal relation to dinner in the evening, irrespective of the stratum defined by the background diabetes treatment.
16018563|NCT02749032|Drug|Sitagliptin|The dosage of sitagliptin depended on the stratum defined by the background diabetes medication. In patients treated with diet and exercise (no other glucose-.lowering medication), sitagliptin was given as one 100 mg in the morning (15 minutes prior to breakfast or the test meal, on the last day of the treatment period), and a corresponding placebo tablet was administered in the evening (no temporal relation to dinner required).
16018564|NCT02749032|Drug|Placebo|Placebo was administered orally twice daily: 15 minutes prior to breakfast or the test meal on the last day of treatment period) and one dose in the evening (no temporal relation to dinner required).
16018565|NCT02749032|Drug|Metformin|For patients continuing with pre-existing metformin treatment, 1000 mg film coated tablets from commercial sources. In half of the patients (stratum: metformin as background medication), metformin was administered orally twice daily at 1000 mg of active compound during of after breakfast and dinner.
16018566|NCT02749032|Other|Diet and exercise|Patients treated their diabetes mellitus type 2 with diet/exercise only
16018567|NCT02749019|Drug|68Ga-NOTA-BBN-RGD|68Ga-NOTA-BBN-RGD were injected into the patients before the PET/CT scans
16018644|NCT02748486|Behavioral|Group discussion|Group discussion of current events
16019840|NCT02739568|Drug|Pitolisant (BF2.649)|
16018568|NCT02749006|Device|iTBS repetitive Transcranial Magnetic Stimulation (rTMS)|rTMS is a non-invasive procedure in which cerebral electrical activity is influenced by a rapidly changing magnetic field. The magnetic field is created by a plastic-encased coil which is placed over the patient's scalp. The magnetic field can be directed onto specific areas of the brain. rTMS can modulate cerebral activity by low or high frequencies. Over time, the magnetic field pulses can gradually change the activity level of the stimulated brain region and help symptoms of bipolar depression.
16018569|NCT02749006|Device|Sham rTMS|Sham rTMS involves a click replicating the sound of the magnetic discharge, without any magnetic pulse being delivered.
16018570|NCT02748993|Drug|PAC-14028 Cream 0.1%|Topical application
16018571|NCT02748993|Drug|PAC-14028 Cream 0.3%|Topical application
16018572|NCT02748993|Drug|PAC-14028 Cream 1.0%|Topical application
16018573|NCT02748993|Drug|PAC-14028 Cream Vehicle|Topical application
16018574|NCT02748967|Drug|ExPEC4V|Participant will receive single dose 0.5 ml of ExPEC4V as intramuscular injection on Day 1.
16018575|NCT02748967|Drug|Placebo|Participant will receive single dose of Placebo on Day 1.
16018576|NCT02748954|Behavioral|Thoughts|"Thoughts. Increasing helpful thoughts consisted of two psychoeducational segments (i.e., thoughts affect emotions, and how to manage harmful thoughts), and a list of helpful thoughts that participants could choose to use to increase their mood for the next week."
16018577|NCT02748954|Behavioral|Activities.|"Increasing activity level included a brief description of how activities affect mood. Participants were then asked to choose the activities they could use to improve their mood from an available list of helpful activities; users were also able to generate their own helpful activities. Participants were also presented with examples of unhelpful activities such as staying in bed and being isolated"
16018578|NCT02748954|Behavioral|Assertiveness.|Increasing assertiveness, consisting of tips for communicating assertively, and an example of an assertive statement. Participants were asked to describe a recent conflict and apply the intervention's assertiveness techniques to address the conflict.
16018579|NCT02748954|Behavioral|Sleep hygiene|"Increasing sleep hygiene included a description on how sleep can affect mood. Participants were also asked to select from a list of helpful sleep hygiene suggestions to be practiced within the next week such as, Don't take naps during the day and Use the bed/bedroom for sleep or sex only."
16018580|NCT02748954|Behavioral|Own Methods|wherein participants were asked to identify four of their own personal strategies that have helped them improve their mood in the past.
16018581|NCT02748941|Device|HITS quantification, Ultrasound examinations, High Resolution MRI|"Simultaneously measure the occurrence of the event (ischemic stroke) and the characteristics of the atheromatous plaque
~Description of different modalities:
~HITS quantification
~Ultrasound examinations:
~Ulceration >2 mm
~Plaque thickness
~GSM: computer analysis after normalization of most informative longitudinal view (image with maximum plaque area) using Photoshop
~CEUS: plaque vascularization detection after bolus injection of SONOVUE on a video recording from the injection of the contrast (Vuebox - Bracco imaging)
~High Resolution MRI:
~Stenosis severity, intraplaque hemorrhage, large lipid-rich necrotic core, ulceration or cap rupture and Brain MRI will be evaluated
~Quantification of shear stresses (Pa) on the surface of the plaque
~mi-RNA identification and quantification"
16018582|NCT02748928|Device|UltraShape Power|Tissue selectivity is achieved by a proprietary knowledge of ultrasound parameters ensuring specific destruction of the fat cells only within the target area. All other types of tissue, such as blood vessels, muscles and peripheral nerves remain intact. There are no thermal effects. Fat cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time
16018583|NCT02748915|Other|Electrophysiological and psychoacoustic tests|
16018584|NCT02748902|Drug|ingenol mebutate 0.05% gel|Ingenol mebutate 0.05% gel applied to a minimum of two and a maximum of five common warts on days 1 and 2.
16018585|NCT02748889|Drug|Carboplatin|Standard chemotherapy
16018586|NCT02748889|Drug|Etoposide|Standard chemotherapy
16018587|NCT02748889|Biological|MPDL3280A|Experimental biologic
16018588|NCT02748876|Other|His-Ventricular (HV) optimisation|Optimisation of atrioventricular pacing interval
16018589|NCT02748863|Drug|Placebo|2 mL + 2 x 1 mL Placebo s.c. at randomization, weeks 1, 3, and 4, thereafter 4-weekly until week 48
16018590|NCT02748863|Drug|Secukinumab 2 mL form|Secukinumab 300 mg/2mL + 2 x 1 mL placebo s.c. at randomization, week 1 , 3, 4, thereafter 4-weekly until Week 48
16018591|NCT02748863|Drug|Secukinumab 1 mL form|Secukinumab 150 mg/1mL x 2 + 2 mL placebo s.c. at randomization, week 1 , 3, 4, thereafter 4-weekly until Week 48
16018592|NCT02748850|Biological|blood sample|a blood sample 20 milliliter
16018593|NCT02748850|Biological|Stem cell donation|The volume of stem cells remained in the tube is recovered
16018594|NCT02748837|Drug|ERY974|
16018595|NCT02748811|Other|Intervention group|The intervention group also receives standard treatment with 6 months of adjuvant chemotherapy or first -line chemotherapy until operation, other scheduled change of treatment or progression. The participants will simultaneously receive full geriatric assessement and intervention. The clinical examination includes laboratory parameters, review of medication list, psycho-cognitive assessement, screening for malnutrition and need of physiotherapy, optimizing social support. Validated quality of life questionnaires will be filled in prior to start, after 2 months and at the end of treatment.
16018596|NCT02748798|Drug|HP 3He|3He will be hyperpolarized using a custom-built polarizer to enhance its MRI signal. Hyperpolarization does not change the chemical or physical properties of helium gas.
16018597|NCT02748798|Drug|HP 129Xe|129Xe will be hyperpolarized using a Xemed polarizer to enhance its MRI signal. Hyperpolarization does not change the chemical or physical properties of xenon gas.
16018598|NCT02748798|Drug|PFP|Perfluoropropane (PFP) will be premixed and delivered to the participants with no further processing.
16018599|NCT02748798|Drug|SF6|Sulfur hexafluoride (SF6) will be premixed and delivered to the participant with no further processing.
16018600|NCT02748798|Device|129Xe Small and Large Human Lung Coil|The investigational 129Xe small and large quadrature lung coils are sensitive to 129Xe resonant frequencies and therefore will be paired with the investigational drug 129Xe. The size of the coil used will depend on the participants' body size.
16018601|NCT02748798|Device|3He Human Lung Coil|The investigational 3He quadrature lung coil is sensitive to 3He resonant frequencies and therefore will be paired with the investigational drug 3He.
16018602|NCT02748798|Device|PFP and SF6 Human Lung Coil|The investigational PFP and SF6 quadrature lung coil is sensitive to inert fluorinated gas resonant frequencies and therefore will be paired with both PFP and SF6.
16018603|NCT02748785|Drug|Methotrexate|Methotrexate will be continued
16018604|NCT02748785|Biological|Seasonal Influenza vaccine|all subjects will be vaccinated with a seasonal influenza vaccine
16018605|NCT02748772|Drug|Two Anti-angiogenesis Drugs（Endostar and Thalidomide）|Endostar:30 mg/d, CIV (continous intravenous pumping) on day 7 of each 21 day cycle，5 days before the chemotherapy is the first day; Thalidomide:100-200mg/d,PO (peros) on day 14 of each 21 day cycle Number of Cycles: 6 cycle or progression or unacceptable toxicity develops.
16018606|NCT02748772|Drug|Pure chemotherapy（Xelox）|"CapeOX (also called XELOX) is a chemotherapy regimen consisting of capecitabine (trade name Xeloda) combined with oxaliplatin.
~Oxaliplatin 130mg/m2 IV over 2 hours,day1 Capecitabine 850-1000mg/m2 twice daily PO for 14 days Repeat every 3 weeks Number of Cycles: 6 cycle or progression or unacceptable toxicity develops."
16018607|NCT02748759|Device|CPM|15 repetitions of flexo-extensión with a commercially available CPM device (Kinetec Advanced Prima)
16018608|NCT02748759|Other|Manual mobilization|Manual mobilization using the Kaltenborn approach, in which 15 tibiofemoral glides were applied by a physiotherapist
16018609|NCT02748746|Device|Bio Impedance Analysis Measurement|Self-adhesive electrodes will be placed to related side's hand dorsum and foot dorsum regarding to calculate for left or right upper extremity's impedance. After completing the measurements for each side, results will be saved by device and documented on paper. A patient total measurement time lasts approximately 3 minutes.
16018610|NCT02748746|Device|Tissue Dielectric Constant Measurement|In this study, TDC device (Moisture Meter-D compact-MMDc will be implemented to upper extremity both affected and unaffected side. 6 cm lower point of cubital crease, 8 cm upper point of cubital crease and 10 cm lower point of armpit will be marked on two sides with a soft pen before measurement. A gentle pressure must required to have accurate sub-tissue fluid percent. Triplicate measurements will be done and taken those average value for each point in order to reach sensitive screening. Computer software simultaneously save these measurements results automatically. A patient total measurement time approximately lasts 5 minutes.
16018611|NCT02748733|Other|Adapted double mini PET|The modified double mini PET mimics the treatment of adapted PD and thus allows its validation
16018612|NCT02748733|Other|Standard double mini PET|The standard double mini PET reflects the routine PD treatment in children and is used for standardized comparison
16018613|NCT02748720|Other|RFM (device) Visible|Will measure the expire tidal volume, end tidal CO2 and peak pressure changes according to clinical improvement and tidal volume
16018614|NCT02748707|Drug|Arm1|Drug (Celecoxib as 200mg twice daily) given orally for 21 days after confirmation by biopsy and before definitive treatment by surgery
16018615|NCT02748707|Drug|Arm 2|Drug (ERLOTINIB 150 mg daily) given orally for 21 days after confirmation by biopsy and before definitive treatment by surgery
16018616|NCT02748707|Drug|Arm 3|Drugs (Celecoxib 200mg twice daily and Erlotinib 150mg once daily) given orally for 21 days after confirmation by biopsy and before definitive treatment by surgery
16018617|NCT02748707|Other|Arm 4|Patients randomized to this arm will be observed for 21 days before definitive treatment by surgery.Having a control group is ethically justifiable because the average waiting time in our hospital prior to definitive treatment is 30 days after diagnosis.
16018618|NCT02748694|Drug|TAK-041|TAK-041 tablets or oral suspension.
16018619|NCT02748694|Drug|TAK-041 Placebo|TAK-041 placebo-matching suspension or tablet.
16018620|NCT02748681|Device|Auto CPAP AirSense™ 10(Resmed)|AutoSet CPAP without telemedicine monitoring
16018621|NCT02748668|Other|Blood specimen collection|
16018622|NCT02748655|Other|Alkaline ionized water|
16018623|NCT02748655|Other|Tap water|
16018624|NCT02748642|Drug|BITS7201A|BITS72014A will be administered on Day 1 in Part A and on Days 1, 28, and 57 in Part B.
16018625|NCT02748642|Drug|Placebo|Placebo matched to BITS72014A will be administered on Day 1 in Part A and on Days 1, 28, and 57 in Part B.
16018626|NCT02748629|Device|Covidien Parietex ProGrip Self-Fixating Mesh|
16018627|NCT02748629|Device|Lightweight Polypropylene Mesh (<38g/m2 after absorption)|Serag Wiessner SERAMESH® PA 15x10 cm
16018628|NCT02748616|Drug|Ursodiol|Subjects will begin to take 300 mg Ursodiol 2 (two) weeks after Visit #1 for a total of 8 (eight) weeks.
16018629|NCT02748590|Device|InterStim II Neurostimulator Model 3058|The neuromodulation will be carried out according to the usual protocol: Hospitalization for the establishment of percutaneous electrode in the operating room under general anesthesia with fluoroscopic control. The pacemaker startup will be performed within 12h after surgery
16018630|NCT02748577|Other|Questionnaires|Before the experimental session, participants will use REDCap to complete several questionnaires used to assess outcomes.
16018631|NCT02748577|Other|Quantitative Sensory Testing (QST) Pain Measurements|Investigators will administer noxious thermal stimulation to assess pain threshold temperatures and assess responses to pain on measures of pain intensity and pain unpleasantness
16018632|NCT02748564|Biological|Aldesleukin|Given IV
16018633|NCT02748564|Other|Laboratory Biomarker Analysis|Correlative studies
16018634|NCT02748564|Biological|Pembrolizumab|Given IV
16018635|NCT02748551|Procedure|Laparoscopic procedures|Laparoscopic surgery
16018636|NCT02748551|Procedure|Open Surgery|Open surgery
16018637|NCT02748525|Other|Milk|Milk, in the form of 8 oz. half and half, administered after CCK scan, and patient is rescanned and ejection fraction measured to determine if ejection fraction is low.
16018638|NCT02748525|Biological|CCK|CCK is standard of care, used in HIDA scans for gallbladder function evaluation. It is given intravenously to cause the gallbladder to contract. The usual dose of CCK is 0.02mg/kg slowly over 3 minutes as per standard.
16018639|NCT02748512|Drug|FAI Insert administered using the Mk II inserter|
16018640|NCT02748512|Drug|FAI Insert administered using the Mk I inserter|
16018641|NCT02748499|Other|Healthy Beat Accupunch (HBA) exercise program|HBA has three phases and takes 40 minutes to complete.
16018642|NCT02748499|Other|Control|Participants maintain their daily acitvities.
16018643|NCT02748486|Behavioral|Metacognitive Training Jumping to Conclusion|Therapeutical intervention based on cognitive-behavioural therapy paradigm. Addresses cognitive bias of schizophrenia patients - jumping to conclusion.
16018645|NCT02748486|Behavioral|Metacognitive Training To Empathize|Therapeutical intervention based on cognitive-behavioural therapy paradigm. Addresses cognitive bias of schizophrenia patients - Theory of Mind deficits.
16018646|NCT02748473|Other|Pilates Exercises program|"The volunteers were divided in two groups:
~Group I: Pilates exercise program involving only the Pilates exercises protocol Group II: Pilates exercises program with voluntary pelvic floor muscle contraction.
~The protocol of both groups consisted of 24 bi-weekly 1-h individual sessions of Pilates exercises program.
~Both groups performed the same protocol . For the group PEP + PFMC the instructor asked for the maximum contraction muscle of the pelvic floor muscle, during expirations with 5 repetitions performed alternately, thus avoiding pelvic floor muscle exhaustion.
~After the 24 sessions, both groups were retested with the same measured methods of the baseline."
16018647|NCT02748473|Other|Pelvic floor muscle strength|evaluated the pelvic floor strength by oxford scale and vaginal pressure before and after the 12 sessions with Pilates Exercises Program on sedentary nulliparous women
16018648|NCT02748473|Other|3D perineal ultrasound|evaluated the pubovisceral muscle thickness and levator hiatus area by 3D perineal ultrasound before and after the 12 sessions with Pilates Exercises Program on sedentary nulliparous women
16018649|NCT02748447|Device|Automated FiO2 adjustment|AVEA ventilator according to SpO2 target range delivers an automated FiO2
16018650|NCT02748434|Other|Lipohypertrophy|
16018651|NCT02748434|Other|Normal Subcutaneous Tissue|
16018652|NCT02748421|Procedure|Lumera Microscope with OCT RESCAN|macular membrane dissection with OCT RESCAN
16018653|NCT02748421|Procedure|Conventional Microscope|macular membrane dissection without OCT RESCAN
16018654|NCT02748408|Device|SMS femoral stem|
16018655|NCT02748395|Drug|Triamcinolone|
16018656|NCT02748395|Other|Placebo|
16018657|NCT02748395|Drug|Lidocaine|
16018658|NCT02748382|Other|higher chloride crystalloid|Normal saline
16018659|NCT02748382|Other|higher chloride albumin|5% Octalbin
16018660|NCT02748382|Other|lower chloride crystalloid|Ringers Lactate
16018661|NCT02748382|Other|lower chloride albumin|5% Plasbumin
16018662|NCT02748369|Drug|Somatostatin|Somatostatin infusion to create a low insulin state.
16018663|NCT02748369|Drug|Glucagon|Glucagon infusion in the setting of ongoing somatostatin.
16018664|NCT02748356|Drug|Lactobacillus|Eligible patients will undergo 1 Lactobacillus pediatric dose (Culturelle GG 10 Billion live organisms) instillation by study personnel at the study site. For the intravesicular Lactobacillus instillation, the contents of 1 Lactobacillus capsule will be mixed into sterile 0.9% saline using an age-based estimate of bladder capacity. Similar to adults, this bladder instillation will represent 10% of the estimated maximum bladder volume based on age.
16018665|NCT02748343|Device|allograft bone|Use of the allograft bone to treat the bone defect in patients
16018666|NCT02748343|Device|tissue-engineered bone|Use of the tissue-engineered bone to treat the bone defect in patients
16018667|NCT02748330|Drug|Ticagrelor|Ticagrelor
16018668|NCT02748330|Drug|Clopidogrel|Clopidogrel
16018669|NCT02748330|Drug|Aspirin|Acetylsalicylic acid
16018670|NCT02748317|Drug|Lactobacillus rhamnosus GG|For the intravesicular Lactobacillus instillation, participants will be instructed to mix the contents of 1 Lactobacillus capsule into 45 cc sterile 0.9% saline.5,6 After mixing, participants will draw up the 45 cc of the liquid Lactobacillus mixture into a 60cc catheter tip syringe and instill via the intermittent catheter after the last catheterization prior to going to bed. Participants will receive 10 Lactobacillus GG tabs at the beginning of treatment phase. At the end of each month, the coordinator or RA will ask how many remaining tablets the participant has, and if needed dispense the next supply of 10 tablets Participants will be instructed to complete the USQ-NB weekly.
16018671|NCT02748304|Other|control|just follow up
16018672|NCT02748304|Drug|sorafenib|sorafenib 400mg bid po
16018673|NCT02748304|Drug|aspirin|aspirin 100mg qd po
16018674|NCT02748291|Other|Walking|"The intervention group will be asked to walk a minimum 6,000 steps per day (7 days a week).
~Participants will be provided with a pedometer and daily diary to record step counts.
~Weekly scores will be collected via telephone contact.
~Followup questionnaires will be at 6, 12 and 24 months."
16018675|NCT02748291|Other|Department of Health Physical Activity Guidelines|"Adults should aim to be active daily. Over a week, activity should add up to at least 150 minutes (2½ hours) of moderate intensity activity in bouts of 10 minutes or more - one way to approach this is to do 30 minutes on at least 5 days a week.
~Alternatively, comparable benefits can be achieved through 75 minutes of vigorous intensity activity spread across the week or combinations of moderate and vigorous intensity activity.
~Adults should also undertake physical activity to improve muscle strength on at least two days a week.
~All adults should minimise the amount of time spent being sedentary (sitting) for extended periods."
16018676|NCT02748278|Procedure|Transvaginal ultrasound-guided oocyte retrieval|Transvaginal ultrasound-guided oocyte retrieval will be performed 34-36 hours after hCG injection.
16018677|NCT02748278|Procedure|Embryo transfer|One or two embryos will be replaced on day 2-5 after oocyte retrieval.
16018678|NCT02748265|Drug|Inhaled Epoprostenol and phenylephrine|After 30 minutes of one-lung ventilation, Epoprostenol 50 ng/kg/min is administered via nebuliser in the anesthesia circuit with phenylephrine administered intravenously
16018679|NCT02748265|Drug|Sevoflurane|Volatile maintenance anesthesia
16018680|NCT02748265|Drug|Propofol|Intravenous maintenance anesthesia
16018681|NCT02748252|Other|stroke center referral|
16018682|NCT02748239|Behavioral|MEDIAS 2 CT|The MEDIAS 2 CT is a education program for the initiation of a conventional insulin therapy in type 2 diabetic patients. The program consists of 6 lessons and is conducted in group settings (4-8 participants).
16018683|NCT02748239|Behavioral|Current CT program|The Current CT program is currently used for the initiation of conventional insulin therapy in type 2 diabetic patients. The program consists of 6 lessons and is conducted in group settings (4-8 participants).
16018684|NCT02748226|Procedure|endovascular treatment|endovascular treatment
16018685|NCT02748213|Drug|Xeloda|Participants will receive oral Xeloda, 950 mg/m^2 twice a day on Days 1 to 14 of each 21-day cycle.
16018748|NCT02747628|Drug|transdermal therapeutic system- nicotine.|Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded.
16018686|NCT02748213|Drug|Taxotere|Participants will receive Taxotere, 75 milligrams per meter-squared (mg/m^2) in the Herceptin + Taxotere + Xeloda arm or 100 mg/m^2 in the Herceptin + Taxotere arm, via IV infusion on Day 1 of each 21-day cycle. The lower starting dose will be used in the triple-therapy arm.
16018687|NCT02748213|Drug|Herceptin|Participants will receive Herceptin, 6 milligrams per kilogram (mg/kg) via IV infusion, on Day 1 of each 21-day cycle. The first dose will be a loading dose of 8 mg/kg in Cycle 1; the dose of 6 mg/kg will be given from Cycle 2 onward.
16018688|NCT02748200|Radiation|external beam radiotherapy (EBRT)|EBRT: 3 dose escalation levels
16018689|NCT02748187|Other|CBASP|Interpersonal psychotherapy for chronic depression
16018690|NCT02748174|Behavioral|Audio Files|Patients will be given a link to download audio files. They consist of breathing techniques, imaging, progressive relaxation, and more. Patients will be asked to perform 20 minutes of relaxation therapy at least 3 times per week. Patients will record their headache frequency and intensivy, in addition to other symptoms, and the frequency of practiving the behavioral therapy using Curelator Headache.
16018691|NCT02748161|Procedure|DEB-TACE|Transarterial chemoembolization with doxorubicin-eluting beads.
16018692|NCT02748148|Other|Medication therapy management|Implementation of a systematic approach to evidence- and personalized-based medicine through a pharmacist-guided medication therapy management service
16018693|NCT02748135|Drug|TB-403 20mg/kg|bi-weekly intravenous doses of TB-403 20mg/kg
16018694|NCT02748135|Drug|TB-403 50mg/kg|bi-weekly intravenous doses of TB-403 50mg/kg
16018695|NCT02748135|Drug|TB-403 100mg/kg|bi-weekly intravenous doses of TB-403 100mg/kg
16018696|NCT02748135|Drug|TB-403 175mg/kg|bi-weekly intravenous doses of TB-403 175mg/kg
16018697|NCT02748122|Other|MMT 723|Subjects will have the insulin pump inserted. With the aid of a small needle, the catheter (tube) of the insulin pump will be inserted through the skin into fatty tissue and will be taped in place. The subject will be required to wear the pump for three (3) months.
16018698|NCT02748109|Behavioral|Vestibular Rehabilitation + audio biofeedback|Vestibular rehabilitation paired with audio biofeedback for balance control 2 times per week with a physical therapist for 6 weeks.
16018699|NCT02748109|Behavioral|Vestibular Rehabilitation|Standard vestibular rehabilitation 2 times per week with a physical therapist for 6 weeks.
16018700|NCT02748096|Procedure|Patient Specific Instrumentation|Patients will undergo a medial unicompartmental knee replacement. This knee replacement is implanted using patient specific cutting guides that have been produced based on the patient's individual anatomy (using plans from pre-operative MRI scans of the patient's knee).
16018701|NCT02748096|Procedure|Conventional Instrumentation|Patients will undergo a medial unicompartmental knee replacement using standard conventional instruments.
16018702|NCT02748083|Device|tDCS|Electrodes for tDCS will have the anode placed over the left DLPFC (F3) and the cathode over the contralateral (right) supraorbital ridge. The exact location of electrodes will be determined by the 10/20 EEG method with EEG cap. Subjects will have tDCS sessions on consecutive days (weekends and holidays excluded). The tDCS group will have 10 active or sham tDCS sessions. The active group will be stimulated with a 2 mA current for 20 minutes.
16018703|NCT02748083|Device|Sham tDCS|Electrodes for tDCS will have the anode placed over the left DLPFC (F3) and the cathode over the contralateral (right) supraorbital ridge. The exact location of electrodes will be determined by the 10/20 EEG method with EEG cap. Subjects will have tDCS sessions on consecutive days (weekends and holidays excluded). The sham tDCS group will have 10 active or sham tDCS sessions. The sham group will have stimulation lasting only 40 seconds though the electrodes will remain in place for 20 min.
16018704|NCT02748070|Drug|Prednisone|
16018705|NCT02748070|Drug|Flonase|
16018706|NCT02748057|Drug|Ezetimibe|
16018707|NCT02748057|Drug|Rosuvastatin|
16018708|NCT02748044|Device|CC-Cruiser|An artificial intelligence to make comprehensive evaluation and treatment decision of congenital cataracts
16018709|NCT02748031|Procedure|slit-lamp-adapted anterior segmental photography|The eligible patients underwent pupil dilation and slit-lamp-adapted anterior segmental photography to electronically record and monitor the morphology of their cataractous lens.
16018712|NCT02748005|Dietary Supplement|Fenugreek seeds extract 500 mg|one cap once a day
16018713|NCT02747979|Other|hemodialysis only|hemodialysis treatment only
16018714|NCT02747979|Other|hemodialysis plus hemoperfusion(HA330)|combination of hemodialysis and hemoperfusion (HA330) treatment
16018715|NCT02747979|Other|hemodialysis plus hemoperfusion(HA130)|combination of hemodialysis and hemoperfusion (HA130) treatment
16018716|NCT02747953|Drug|Gilotrif|50 mg with an option to reduce the dose to 40mg or 30 mg once a day Continuous daily dosing, one course consists of 28 days. Patients are eligible for repeated treatment courses in the absence of disease progression and undue toxicity.
16018717|NCT02747940|Drug|flunarizine and/or pregabalin|
16018718|NCT02747927|Drug|Placebo|TDV placebo-matching SC injection.
16018719|NCT02747927|Biological|Tetravalent Dengue Vaccine (TDV)|TDV SC injection.
16018720|NCT02747914|Device|Transcranial magnetic stimulation|
16018721|NCT02747914|Other|Conventional exercise|
16018722|NCT02747901|Other|KINESIOTAPING|Kinesiotaping group received kinesiotape for lymphatic correction and rectus femoris facilitation technique.
16018723|NCT02747901|Other|COLD THERAPY|Cold therapy group received cold packs immediately after operation and following postoperative days
16018724|NCT02747888|Genetic|•Referral to Genetic Counselor, if indicated|
16018749|NCT02747628|Drug|transdermal therapeutic system- melatonin.|Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded.
16018750|NCT02747615|Other|transfused pre-operatively donated autologous blood.|Pre-operative autologous donation for minimising perioperative allogeneic blood transfusion
16018751|NCT02747615|Drug|intravenous tranexamic acid (TXA) infusion|Intravenous tranexamic acid is a safe pharmacological treatment to reduce blood loss and transfusion requirements in patients undergoing major orthopedic surgery.
16018725|NCT02747875|Drug|Methadone|The treatment phase will begin at the induction of general anesthesia and finish at the end of the surgical procedure. Under the direction of the cardiac anesthesiologist subjects will be premedicated and general anesthesia will be induced with standard anesthetic monitoring and management. Participants will receive 0.3 mg/kg of methadone prior to surgical incision, over 20 minutes. General anesthesia will be maintained with inhalational anesthetics and paralytics. The subject will continue to be evaluated for hemodynamic stability, bleeding, and respiratory effort. The postoperative intensive care phase will begin at time of room admission and end at day three of hospital stay. All subjects will receive morphine or oxycodone analgesics and sedation medication based on the hospital's postoperative pain control and agitation protocol. Standard electronic documentation will be maintained throughout and include: medications, vital signs, and events.
16018726|NCT02747875|Drug|Fentanyl|The treatment phase will begin at the induction of general anesthesia and finish at the end of the surgical procedure. Under the direction of the cardiac anesthesiologist subjects will be premedicated and general anesthesia will be induced with standard anesthetic monitoring and management. Participants will receive 20 mcg/kg of fentanyl prior to surgical incision, over 20 minutes. General anesthesia will be maintained with inhalational anesthetics and paralytics. The subject will continue to be evaluated for hemodynamic stability, bleeding, and respiratory effort. The postoperative intensive care phase will begin at time of room admission and end at day three of hospital stay. All subjects will receive morphine or oxycodone analgesics and sedation medication based on the hospital's postoperative pain control and agitation protocol. Standard electronic documentation will be maintained throughout and include: medications, vital signs, and events.
16018727|NCT02747862|Other|Chart Review|"Database queried for the presence of cases meeting criteria (attenuated FAP, classical AFP [i.e. identifiable APC mutation], and/or a compatible family history or personal adenoma burden of > 50 adenomas).
~The data related to the patients with attenuated FAP and classical AFP who underwent endoscopic surveillance or surgery collected through chart review and all data is retrospective as of February 15, 2016."
16018728|NCT02747849|Device|TENS|Placebo had stimulator placed on hand. Active comparator had stimulator placed on foot. Amount of time, intensity, threshold voltage, pulsewidth and frequency remained the same for both arms.
16018729|NCT02747836|Other|Ultrasound of the wrist|using sound waves to create images capturing the movement of the SSCT and flexor tendon and transformation of the median nerve in the wrist
16018730|NCT02747823|Biological|CBT124|1 mg/kg IV infusion
16018731|NCT02747823|Biological|EU Sourced Avastin®|1 mg/kg IV infusion
16018732|NCT02747823|Biological|US Sourced Avastin®|1 mg/kg IV infusion
16018733|NCT02747810|Device|NewTENS Design|This device functions the same as the FDA approved TENS unit, but provides a small, inexpensive unit that will be easy for a child to use. The stimulation characteristics include a continuous frequency of 5 Hz, pulsewidth 0.2 ms, and intensity 2-4 times the threshold voltage required for inducing toe twitching - or the intensity that the subject feels comfortable with. The subjects will also be instructed how to use the stimulator and where to attach the electrodes on the foot at the beginning of the study. The investigator will provide the stimulator and electrodes. The subjects will be asked to wear socks to prevent the electrodes from detachment and to stop the stimulation during walking or in any non-resting situation. Subjects will be asked to use the stimulator for a MINIMUM of 60 minutes in the evening prior to bedtime at home for two weeks. They will be encouraged to use the stimulator for more time than the minimum as long as they accurately record the total duration.
16018734|NCT02747797|Drug|Lucitanib|10 mg orally daily
16018735|NCT02747784|Behavioral|Cognitive training program RehaCom®|Cognitive training program RehaCom®
16018736|NCT02747771|Behavioral|Cognitive behavioral therapy|10 sessions Group therapy during 10-12 weeks. The first three sessions focus on habit reversal training, the fourth to sixth session on acceptance and commitment therapy and the last four sessions aims at integrating the two approaches.
16018737|NCT02747758|Device|cathodal transcranial direct current stimulation (tDCS)|transcranial direct current stimulation (tDCS) is applied in active groups using cathodal active M1 stimulation. Active stimulation is applied with 2mA direct current via 20cm² electrodes.
16018738|NCT02747758|Device|sham transcranial direct current stimulation (tDCS)|transcranial direct current stimulation (tDCS) is applied in active groups using a sham-stimulation including ramp up and ramp down of current.
16018739|NCT02747758|Device|anodal transcranial direct current stimulation (tDCS)|transcranial direct current stimulation (tDCS) is applied in active groups using anodal active M1 stimulation. Active stimulation is applied with 2mA direct current via 20cm² electrodes.
16018740|NCT02747745|Behavioral|Four risk areas reflecting the great needs of FCGs of PWDs|The intervention involves home visits & phone calls from the case manager to the dyads, and receiving telephone calls from FCGs. The case manager will target the prioritized risk from the 4 risk areas of FCG problems and healthy behaviors. The intervention mainly consists of needs assessment and nursing education on home environment modification and safety, behavioral management and communication skills; home-based cognitive stimulation on PWD with simple mathematical practice, patient preferred leisure activities and reminiscence by old time photos, stories and toys; brief consultation on 4 risk areas related to FCG stress; and case management to refer the dyads to the hospital-based dementia centers and community resources.
16018741|NCT02747732|Drug|Bendamustine 90 mg/m2 IV on Days 1-2, Cycles 1-6|"Therapy initiation 30 days max from screening.
~Bendamustine 90 mg/m2 IV on Days 1-2, Cycles 1-6 Rituximab 375 mg/m2 IV Day 1, Cycles 1-6; a cycle is defined as 28 days Ibrutinib, 560 mg orally, once daily, continuously starting on Cycle 1, Day 1 until disease progression, toxicity or referral for allo-SCT"
16018742|NCT02747719|Behavioral|Light and exercise|Exposure to light and exercise
16018743|NCT02747706|Behavioral|Parent-to-parent mentoring|phone, SMS/text, and smartphone-based support
16018744|NCT02747680|Other|hypoglycemia (low blood sugar) in MRI|hypoglycemia (low blood sugar) in MRI
16018745|NCT02747654|Genetic|genotype|Patients were randomly assigned to a standard treatment group; INH dose of 300 mg or 200 mg based on the body weight) or model-based treatment group; INH dose determined based on developed model,
16018746|NCT02747641|Procedure|Pixel CO2 Laser System|
16018747|NCT02747628|Drug|Placebo|Postoperative pain was evaluated based on visual analogue scale, first time to ask for rescue analgesia and total pethidine requirements (mg) in 12 hours postoperatively were also recorded.
16018752|NCT02747615|Other|transfused only allogeneic blood.|
16018753|NCT02747602|Drug|AC-1204|40 g (120 mL) AC-1204 administered 30 minutes after the start of a standard breakfast.
16018754|NCT02747602|Drug|caprylic triglyceride oil (standard breakfast)|20 g CT oil (21 mL) administered 30 minutes after the start of a standard breakfast.
16018755|NCT02747602|Drug|caprylic triglyceride oil (high fat breakfast)|20 g CT oil (21 mL) administered 30 minutes after the start of a high fat breakfast.
16018756|NCT02747589|Procedure|Surgical device implant in brain|Neuropace RNS implant ove visual cortex
16018757|NCT02747563|Other|Blood test (PSA)|Measurement of blood PSA levels
16018758|NCT02747550|Procedure|LM with TESTO|In subjects allocated to the experimental group, the temporary simultaneous two-arterial occlusions (TESTO) procedure was performed to minimize operative blood loss during laparoscopic myomectomy.
16018759|NCT02747550|Procedure|LM without TESTO|In the control group, no intervention for the temporary simultaneous two-arterial occlusions (TESTO) procedure was made during laparoscopic myomectomy
16018760|NCT02747537|Drug|Sorafenib|
16018761|NCT02747537|Drug|Irinotecan|
16018762|NCT02747524|Other|Vita Mamba peanut butter paste|
16018763|NCT02747511|Drug|Haloperidol|
16018764|NCT02747511|Drug|Placebo|
16018765|NCT02747498|Procedure|Procedure with circumferential pulmonary vein isolation|We will compare circumferential pulmonary vein (PV) isolation (CPVI) alone and posterior box isolation in addition to CPVI in patients with AF recurrence after de novo ablation procedures and with PV reconnections with 1:1 randomization. We will conduct ablation procedures by 3D electroanatomical mapping guidance and confirm bidirectional blocks of each ablation lines by differential pacing. For posterior box isolation, we will ablate remaining atrial potentials with point by point ablation to avoid the risk of esophageal injury at posterior inferior line. In all patients, mapping and ablation for non-pulmonary vein foci will be done with isoproterenol infusion at the end of the procedure. We will compare procedure time, ablation time, procedure related complication rates, and clinical recurrence rate of AF during follow-up period.
16018766|NCT02747498|Procedure|Procedure with linear ablation in addiction to pulmonary vein isolation|We will compare circumferential pulmonary vein (PV) isolation (CPVI) alone and posterior box isolation in addition to CPVI in patients with AF recurrence after de novo ablation procedures and with PV reconnections with 1:1 randomization. We will conduct ablation procedures by 3D electroanatomical mapping guidance and confirm bidirectional blocks of each ablation lines by differential pacing. For posterior box isolation, we will ablate remaining atrial potentials with point by point ablation to avoid the risk of esophageal injury at posterior inferior line. In all patients, mapping and ablation for non-pulmonary vein foci will be done with isoproterenol infusion at the end of the procedure. We will compare procedure time, ablation time, procedure related complication rates, and clinical recurrence rate of AF during follow-up period.
16018767|NCT02747485|Device|Cardiac MRI|
16018768|NCT02747485|Biological|blood samples|Serum levels of biomarkers of myocardial fibrosis (galectine-3 and ST2) will be measured
16018769|NCT02747485|Procedure|myocardial biopsy|
16018770|NCT02747485|Genetic|blood samples|extract DNA to look for genomic mutations associated with the disease.
16018771|NCT02747472|Drug|GIP-A|GIP receptor antagonist
16018772|NCT02747472|Drug|GIP(1-42)|GIP receptor agonist
16018773|NCT02747472|Other|Saline|Placebo
16018774|NCT02747459|Behavioral|Sensory Supported Swimming|A swimming and water safety program for children with autism spectrum disorders. Individualized instruction utilizing evidence-based teaching methods and sensory modifications.
16018775|NCT02747446|Dietary Supplement|added sugar|isocaloric substitution of added sugars (honey or FG) for starch
16018776|NCT02747433|Device|Robot-Assisted Therapy (RT)|Highly repetitive robot-assisted therapy for paretic arm with Armeo (1 hr sessions, 3x week for 3 weeks) followed by robot-assisted therapy for hand motions with Amadeo (3x week for 3 weeks). Robot training to be accompanied with ALPS motor learning program directed toward UE self management and transfer of training to daily activities in home & community.
16018777|NCT02747433|Device|Robot & Task-Oriented Training (RT-TOT)|Highly repetitive robot-assisted therapy for paretic arm with Armeo (30 min sessions, 3x week for 3 weeks) followed by robot-assisted therapy for hand motions with Amadeo (3x week for 3 weeks). Task oriented training will be delivered for remaining 30 mins of each treatment session. Robot and task oriented training to be accompanied with ALPS motor learning program directed toward UE self management and transfer of training to daily activities in home & community.
16018778|NCT02747420|Device|NURO TM|The lower extremity will be palpated and a needle insertion site will be identified 5 cm from the medial malleolus and posterior to the tibia. Between the posterior margin of the tibia and the soleus muscle, a 34-gauge acupuncture-like needle will be inserted 3-4 cm to the tibial nerve. A grounding pad will be placed on the bottom of the foot just below the smallest toe. An inactive grounding pad will be placed on top of the foot above the small toe to be consistent with the sham pad placement. The needle and grounding pad will be connected to the stimulator and the stimulation will be increased from 0 to 10 Milli-ampere. The needle will be taped. The electrical current will be set by the subject and the mA will be recorded. A 30 minute stimulation session will be given at 20 Hz.
16018779|NCT02747420|Device|Sham|"A needle will be inserted into the lower extremity approximately 5 cm cephalad from the medial malleolus and posterior to the tibia. A sham needle will be used a the tibial nerve insertion site. This will stimulate needle placement without puncturing the skin. The needle will be taped in place. The grounding pad from the transcutaneous electrical nerve stimulation (TENS) unit device will be placed on the bottom of the foot below the smallest toe. Another electrode will be placed on the top of the foot above the small toe for conduction. The TENS electrode will be connected to the TENS unit, at 20 Hz (the same as the PTNS group). The unit will be turned on and the stimulation will be increased to the subject's first sensory level. The subject will sense stimulation to either the bottom of the foot or the toe. the TENS unit will be on for a 30 minute test period. The TENS unit will be removed and the needle will be discarded."
16018784|NCT02747394|Other|Working Memory Training|
16018785|NCT02747381|Dietary Supplement|Alfacalcidol|1-alpha hydroxy cholecalciferol 1 mcg
16018920|NCT02746211|Biological|Medium Low Titre Influenza virus|Medium Low Titre Influenza virus
16018786|NCT02747368|Device|Ocusweep system|Comparison of Ocusweep system to conventional visual acuity, contrast sensitivity and visual field testing.
16018787|NCT02747342|Drug|SHR3680; SHR3162|"SHR3680 will be administered orally in dose escalation/expansion phase,
~SHR3680 will be administered orally at a fixed dose together with SHR3162 in combination phase."
16018788|NCT02747329|Device|BuMA Supreme™ stent|
16018789|NCT02747329|Device|Xience V/Prime stent|
16018790|NCT02747316|Other|Stable iron isotope 57 (57Fe) labeled iron solution|test meal labeled with 12 mg 57Fe
16018791|NCT02747316|Other|Stable iron isotope 58 (58Fe) labeled iron solution|test meal labeled with 12 mg 58Fe
16018792|NCT02747303|Procedure|Stereotactic Radiosurgery|The SRS dose will depend on the maximum diameter of the gross tumor volume (GTV)
16018793|NCT02747290|Drug|68Ga-NOTA-BBN-RGD|68Ga-NOTA-BBN-RGD were injected into the patients before the PET/CT scans
16018794|NCT02747264|Device|eRAPID|eRAPID is an online system for patients to self-report symptoms and AE during and after cancer treatments. eRAPID allows AE reporting from home or hospital and enables patient reported data to be integrated into existing EPR to allow for the reports to be used in routine care. In addition the system is capable of generating alerts for severe AE to the relevant clinical team and providing patient advice on managing mild and moderate AE.
16018795|NCT02747251|Other|Strengthen your Shoulder|A simple home-based elastic band strengthening exercise intervention. This program consists of progressive high volume resistance training exercises with an elastic band.
16018796|NCT02747251|Other|Usual Care|"Usual care, consisting of a referral to general rehabilitation in the municipal under the Danish Health Act § 140, most often with the alternative option to choose a private physiotherapeutic clinic, partly at their own expense. Also includes any additional treatment the patient receives between baseline and follow-up, except that included in Strengthen your Shoulder."
16018797|NCT02747238|Device|Ultrasound|The ultrasound imaging of the lumbar spine in different scanning planes facilitates the identification of the landmarks necessary for appropriate epidural space location in pregnant patients. There are two acoustic windows that are effective for lumbar spine sonographic assessment: one seen on the transverse approach, and the other seen on the longitudinal paramedian approach. The ultrasound single-screen method using the transverse approach of the lumbar spine provides reliable information regarding the landmarks required for labor epidurals. The correct interspace and midline position are identified for correct placement of the CSE analgesia.
16018798|NCT02747238|Procedure|No ultrasound|Palpation of anatomical landmarks is used for placement of labor analgesia
16018799|NCT02747238|Procedure|Epidural infusion|An epidural infusion will be started in both groups, regarding of the technique used for placement, and the same solution of Bupivacaine 0.0625% with 2mcg fentanyl/cc will be used in both groups
16018800|NCT02747225|Device|network analyzer|The dielectric properties of the tissues were measured using the open-ended coaxial line method. The measurement system consisted of a network analyzer (Model 4395A, Agilent Corp., Santa Clara, CA) associated with an S-parameter test set (Model 87511A, Agilent Corp., Santa Clara, CA). A semi-rigid coaxial line with a diameter of 3.58 mm was connected to the network analyzer system by using a Bayonet Neill-Concelman connector. The other tip of the coaxial line (probe) was placed on the flat bare surface of the tissue.
16018801|NCT02747212|Device|network analyzer|The dielectric properties of the tissues were measured using the open-ended coaxial line method. The measurement system consisted of a network analyzer (Model 4395A, Agilent Corp., Santa Clara, CA) associated with an S-parameter test set (Model 87511A, Agilent Corp., Santa Clara, CA). A semi-rigid coaxial line with a diameter of 3.58 mm was connected to the network analyzer system by using a Bayonet Neill-Concelman connector. The other tip of the coaxial line (probe) was placed on the flat bare surface of the tissue that placed on a measurements experiment platform.
16018802|NCT02747199|Device|SYNERGY stent|
16018803|NCT02747199|Device|BVS ABSORB scaffold|
16018804|NCT02747186|Drug|Lidocaine|Intraoral maxillary field block
16018805|NCT02747160|Behavioral|Managing Anxiety from Cancer (MAC)|The intervention consists of six telephone-administered sessions. Session topics include psychoeducation on anxiety, behavioral strategies for managing anxiety, cognitive restructuring, communication skills training, acceptance techniques (patient only), problem-solving strategies (caregiver only), and planning for future anxiety. Session content is tailored for older adults and caregivers of older adults with cancer.
16018806|NCT02747147|Device|TIVA blood collection device|the device is attached to a peripheral IV catheter for use as a direct blood draw device into a vacuum tube or a syringe
16018807|NCT02747134|Behavioral|Emotion Regulation and Mindfulness skills|
16018808|NCT02747121|Behavioral|External inspection of health services|The intervention is external inspections of acute hospitals addressing early detection and treatment of sepsis. The intervention is delivered on an organizational level. Individuals are not assigned to an intervention. The investigator use data from individuals to assess if the organizational intervention affects care. Therefore the investigator argues that that the study is observational. The inspection will have two components, a system revision and a follow up audit with verification of patient records 8 months later. The inspection can be considered a complex intervention. The study does not intend to evaluate the individual effects of the different components of the inspection, rather the effect of the inspection as a whole.
16018809|NCT02747108|Behavioral|Blood Test Group Intervention|Patients randomly assigned to the Blood Test Group will complete an HbA1c blood test around the time of their next primary care appointment. Following the HbA1c test, their VA primary care provider will be notified of the test result and will be provided with a detailed interpretation of the result. Trained study staff will then provide brief counseling by phone and written information by mail about their test result. The brief counseling and written information will be based on the American Diabetes Association and National Diabetes Prevention Program guidelines and will emphasize the risk of progression to type 2 diabetes mellitus and the rationale for preventive strategies, encourage aerobic exercise and a calorie-restricted diet to promote and maintain weight loss, and set a goal of achieving and sustaining a weight loss of at least 5% of body weight.
16018810|NCT02747108|Behavioral|Brochure Group Intervention|Participants will be asked to review a handout from the National Center for Health Promotion and Disease Prevention (NCP) on recommended screening tests and immunizations on or around the same date as their next primary care appointment.
16018811|NCT02747095|Device|IQon Spectral CT|Using IQon Spectral CT, Assess the added diagnostic value and impact on workflow of spectral images
16018812|NCT02747082|Procedure|Retreatment of root-filled teeth with infection|Root-filled teeth with infection are being treated with either 1% NaOCl or 2% CHX as disinfection irrigation solution.
16018813|NCT02747069|Device|NICU electronic stethoscope|Assessment of heart rate using the electronic stethoscope for up to 10 minutes compared to ECG and pulse oximetry devices used to monitor neonates whilst on NICU
16018814|NCT02747069|Device|Newborns <32 weeks and ECG|The three leads from the ECG device will be pre placed onto a plastic bag prior to delivery. The pre term infant (<32 weeks) placed into the bag at the time of delivery and heart rate will be assessed for up to 30 minutes
16018815|NCT02747056|Other|clinical, psychological and neuropsychological assessment|the subjects will do 3 tests about executive functions, complete 3 questionnaires about autism and 3 questionnaires about the self concept
16018816|NCT02747056|Other|Autobiographical memories Assessment|The investigators will ask subjects to tell autobiographical memories freely first and, secondly, to specify participants'characteristics by answering focused questions.
16018817|NCT02747056|Other|Autobiographical memories assessment characteristics|During the second time point, the investigators will ask subjects to say the self statements which define them. Then, subjects will have to tell and to specify the characteristics of the autobiographical memories linked to these self statements.
16018818|NCT02747043|Biological|ABP 798|ABP 798 was supplied as a sterile, preservative-free liquid concentrate for IV infusion at a concentration of 10 mg/mL in either 100 mg/10 mL or 500 mg/50 mL single-dose vials. Subjects were to receive premedications before each infusion. Premedications were to be given according to local practice for administration of rituximab therapy.
16018819|NCT02747043|Biological|Rituximab|Rituximab was procured from commercial supplies in the US and was supplied as a sterile, clear, colorless, preservative-free liquid concentrate for IV infusion at a concentration of 10 mg/mL in either 100-mg/10 mL or 500-mg/50 mL single-dose vials. Subjects were to receive premedications before each infusion. Premedications were to be given according to local practice for administration of rituximab therapy.
16018820|NCT02747030|Drug|Ocriplasmin intravenously|Retinal vein cannulation with Ocriplasmin infusion
16018821|NCT02747004|Drug|Abemaciclib|Administered orally
16018822|NCT02747004|Drug|Tamoxifen|Administered orally
16018823|NCT02747004|Drug|Prophylactic Loperamide|Administered orally
16018824|NCT02746991|Drug|Sham Injection|Placebo
16018825|NCT02746991|Drug|FAI Insert|Fluocinolone Acetonide
16018826|NCT02746978|Other|Peer directed education|No drug or device is included. The intervention of interest is the redesigned approach to inpatient education that follows the Stanford chronic disease self management approach which includes peer-led problem solving discussions compared to traditional didactic education lectures provided by nurse educators
16018827|NCT02746978|Other|Patient Engagement Portal|No drug or device interventions. The Engagement Portal is populated by electronic medication record information (demographics, medications, supplies) then owned/maintained by patient after discharge. This approach to managing information and conditions associated with injury will be compared to the traditional approach of providing patients with a large instruction manual to carry home with them.
16018828|NCT02746965|Device|Magpro X100 + Option|In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of MST in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks.
16018829|NCT02746965|Device|ThymatronSystem Ⅳ Electroconvulsive System|In addition to treatment as usual (TAU), participants were supposed to receive ten sessions of modified ECT in four weeks, with three sessions per week in the first two weeks and two sessions per week in the following two weeks.
16018830|NCT02746965|Other|treatment as usual (TAU)|Participants will engage in their inpatient treatment program as-usual.
16018831|NCT02746952|Biological|UCART19|
16018832|NCT02746939|Behavioral|InSciEd Out Fitness and Nutrition Curriculum|Science curriculum is designed in partnership with 3rd and 4th grade teachers and InSciEd Out scientists. The curriculum is designed to focus on inquiry driven science, and also aims to decrease high risk behaviors that can lead to obesity in the students.
16018833|NCT02746926|Drug|tafamidis|
16018834|NCT02746913|Device|Urodynamics|Urodynamics is performed with the Aquarius XT Laborie system and a fluoroscopic images are obtained with a GE OCE 9800 c-arm fluoroscopy unit. Urodynamic testing will be performed in a seated position with a pessary from the ambulatory pessary trial in place. Post residual void will be measured at the start of the urodynamics.
16018835|NCT02746913|Device|Pessary|A pessary is a silicone disc that is used in to support the uterus and vagina of women with vaginal prolapse. During this study, the pessary that will be used is a ring with support. This is a disc shape with a membrane stretched across the center. It is a device used in standard practice and is safe to keep in place for up to 3 months at a time. The subjects will be fit with a pessary asked to wear the pessary for 3 days.
16018836|NCT02746900|Procedure|Cervical cerclage|McDonald cervical cerclage
16018837|NCT02746887|Other|Preterm/term cohort|
16018838|NCT02746874|Procedure|Radiofrequency Ablation (RFA)|The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected prior to lesioning.
16018839|NCT02746874|Procedure|Simulated Radiofrequency Ablation (RFA)|The radiofrequency generator which will be turned on but will not be in the patient's view. The skin overlying the target sites identified with image guidance will be numb using lidocaine 1%. A needle will be placed through the skin to be optimally positioned according to the three targets. Sensory and motor testing will be performed to confirm appropriate placement. Lidocaine 2% 1-2cc will be injected. A simulate sham lesion will be performed at each target site.
16018840|NCT02746861|Behavioral|Peer-Supported DSMS|Phone, SMS/text, and smartphone-based intervention.
16018841|NCT02746848|Biological|Amniotic Membrane Extract Eye Drop|Amniotic Membrane Extract use as eye drop for patients with corneal injury.
16018842|NCT02746835|Other|Exercise program for fall prevention|"Set of exercises to improve the following parameters:
~balance, endurance, muscle strength, flexibility."
16018921|NCT02746211|Biological|Low titre|Low titre
16018922|NCT02746198|Other|probiotic dairy drink|
16018923|NCT02746198|Other|acidified milk|
16018843|NCT02746809|Device|CoreValve Evolut 34R TAVR system|"The CoreValve Evolut 34R System is a transcatheter aortic valve implantation system comprised of the following three components:
~Evolut 34R Transcatheter Aortic Valve (TAV)
~EnVeo R Delivery Catheter System (DCS) with EnVeo R InLine Sheath
~EnVeo R Loading System (LS)"
16018844|NCT02746796|Drug|ONO-4538|
16018845|NCT02746796|Drug|Oxaliplatin|
16018846|NCT02746796|Drug|Tegafur- Gimeracil-Oteracil potassium|
16018847|NCT02746796|Drug|Capecitabine|
16018848|NCT02746796|Drug|Placebo|
16018849|NCT02746783|Drug|Single dose MUTAGRIP® influenza vaccine|All subjects will receive either a single or double doses of MUTAGRIP® containing A/California/7/2009 (H1N1); A/Texas/50/2012 (H3N2); B/Massachusetts/2/2012. The double dose regimen will be administered at the same time.
16018850|NCT02746783|Drug|Double dose of MUTAGRIP® influenza vaccine|All subjects will receive either a single or double doses of MUTAGRIP® containing A/California/7/2009 (H1N1); A/Texas/50/2012 (H3N2); B/Massachusetts/2/2012. The double dose regimen will be administered at the same time.
16018851|NCT02746770|Other|Experimental: Cawthorne and Cooksey exercises group|Experimental: intervention group. Patients assigned to the experimental group will perform the Cawthorne and Cooksey exercises for vestibular rehabilitation in addition to their habitual treatment.
16018852|NCT02746757|Other|Remote conditioning|
16018853|NCT02746757|Drug|Exendin 9-39|
16018854|NCT02746744|Drug|Rituximab|Infusion of Mabthera/Rituximab every 6 months
16018855|NCT02746744|Drug|Dimethyl fumarate|Intake of Tecfidera/Dimethyl Fumarate daily acc. to clinical practice.
16018856|NCT02746744|Drug|Sodium Chloride solution|Placebo/Sham infusion every 6 months so that the examining physician (blinded) should not know which patient gets Mabthera or Tecfidera
16018857|NCT02746731|Other|Cardiorespiratory and resistance training.|"A cardiorespiratory and resistance training program for at least 2 to 3 weeks will be conducted 3-times per week, of which two sessions will be supervised by a qualified person of the institute of physiotherapy and one session will be unsupervised and home-based.
~Physiotherapy consists of one hour, moderate to intense interval training combined with muscle strength training."
16018858|NCT02746731|Other|Reference|No preoperative physical therapy training. Patients will be informed to remain physically active (as usual) until surgery.
16018859|NCT02746718|Other|Blood sample|A blood sample for CPK dosage and pompe disease test
16018860|NCT02746705|Device|Transcranial Direct Current Stimulation (tDCS)|tDCS is a therapeutic development that utilizes low amplitude direct currents to induce changes in cortical excitability. tDCS is expected to produce neuronal polarization of less than one mV (millivolt) 9. tDCS produces relatively diffuse current flow, as demonstrated by imaging studies and computational models
16018861|NCT02746705|Device|Sham Transcranial Direct Current Stimulation|During a sham session, the device is programmed to ramp up to the desired intensity (target 2.0 mA) and ramp down for the initial 60 seconds, with no current delivery during the session, and then again at the end of the session. These brief periods of stimulation serve to mimic the effects of a true stimulation session.
16018862|NCT02746705|Behavioral|Cognitive Training Program|
16018863|NCT02746692|Other|Fit15|"Group-based high-intensity circuit training based on functional movement patterns (e.g. squats, push-ups, burpees, jumps, ropeskipping).
~Total duration 15 minutes circle training: 20s workout, 10 rest"
16018864|NCT02746692|Other|Endurance|Moderate intensity ergometer training. Total duration 50 minutes
16018865|NCT02746679|Other|Mindfulness Based Stress Reduction|Mindfulness Based Stress Reduction programs have been shown to be effective, however, the potential benefits of Mindfulness Based Stress Reduction to decrease depression, anxiety, stress in other diseases. Therefore, the purpose of this study was to examine whether MBSR is effective, and has potential as an intervention to decrease depression, anxiety ,and to improve quality of life of intrauterine adhesion patients.
16018866|NCT02746666|Behavioral|Pharmacist's behavioral intervention|Pharmacist's 30 min counselling on antiemetic therapy, causes of nausea or vomiting and ways to prevent them during chemotherapy.
16018867|NCT02746653|Device|TroClose1200(TM)|Creation of access port and closure it by the same device, TroClose1200(TM)
16018868|NCT02746640|Procedure|Cardiopulmonary resuscitation (CPR)|If there is a cardiopulmonary arrest, investigators observe the working processes of cardiopulmonary resuscitation.
16018869|NCT02746627|Behavioral|Positive Affect|Positive psychology intervention to improve motivation for diabetes management.
16018870|NCT02746627|Behavioral|Education|Educational materials on diabetes management
16018871|NCT02746614|Other|Psychomotor Therapy|Psychomotor Therapy
16018872|NCT02746601|Behavioral|Risk Assessment, Counselling & Resources|A risk assessment tool is completed on a tablet. The results are scanned into the patient's electronic medical record. A healthcare provider gives behavioural counselling on identified risk factors. The patient is given a customized handout that includes health recommendations and resources based on the participant's identified risk factors.
16018873|NCT02746588|Other|Office hysteroscopy|Diagnostic hysteroscopy with biopsy
16018874|NCT02746575|Drug|metoprolol|
16018875|NCT02746562|Procedure|Freeze all|Freezing of all blastocyst stage embryos with thawing and transfer in a subsequent natural cycle
16018876|NCT02746549|Other|renal perfusion|measurement of renal perfusion with MRI arterial spin labelling technique
16018877|NCT02746536|Other|Slow chest compression|"During the SCC, the patient will remain in the sitting position; a bimanual slow compression on his/her upper chest will be performed always by the same evaluator, who will stand behind the patient. This compression will be done only in the expiratory phase, during one minute, in all respiratory cycles, respecting the chest mobility of each patient.
~A standardized verbal command will be given: Exhale all the air."
16018878|NCT02746536|Other|No slow chest compression|"The patient will remain seated at rest for one minute after the 6MST. A standardized verbal command will be given: Exhale all the air."
16018879|NCT02746523|Other|Sensory Organization Test|Balance and proprioception test
16018880|NCT02746523|Genetic|Biomarkers|Blood, urine, and saliva biomarkers
16018881|NCT02746523|Other|Conners' Adult ADHD Rating Scale (CAARS)|Adult ADHD rating scale
16018882|NCT02746523|Other|Depression Scale|Becks Depression Inventory and Patient Health Questionnaire 9 (PHQ-9)
16018883|NCT02746523|Other|Cognitive Assessment|Montreal Cognitive Assessment (MoCA)
16019841|NCT02739568|Drug|Placebo|
16018884|NCT02746510|Genetic|Array comparative genomic hybridization|For each of the 150 patients deoxyribose nucleic acid (DNA) exactracted from a jugal mucosae sample will be analysed by the cytogeneticist and a CGH-a will be performed.
16018885|NCT02746497|Procedure|Acupuncture|"Acupuncture style; Western Medical Acupuncture (WMA). In WMA all types of sham (placebo) acupuncture are believed to produce a certain amount of sensory stimulation and thereby a possible therapeutic effect. In addition, other studies have shown that sham acupuncture is associated with a moderately large nonspecific effect and compared to other inert placebo intervention the effect associated with sham acupuncture might be larger. Thus we use a control group instead of a placebo group.
~Needles; sterile disposable needles (Plandent) size 0.30x30mm. The needles will be inserted perpendicularly and rotated manual between finger and thumb for a few seconds to elicit de-qi. Needle retention time will be 10 minutes. Afterward the needle will be removed. Acupuncture points; CV-3, CV-4, LR-8, SP-6, SP-9. In total 8 points as LR-8, SP-6, SP-9 are given bilaterally."
16018886|NCT02746484|Other|Ability platform program|The Ability program is an at home participant-tailored and technology-enhanced platform a) delivering tablet-based intensive (five days/a week for six weeks) motor and cognitive activities; b) monitoring from remote vital and physical health parameters (i.e., weight, Heart Rate, O2 saturation, daily steps, sleep activity).
16018887|NCT02746484|Other|Usual care program|Usual care at home program (paper and pencil cognitive activities; promotion of physical activity according to healthcare professional's advice)
16018888|NCT02746471|Device|Reveal LINQ|
16018889|NCT02746458|Other|Blood Flow Restriction|Brief and intermittent blood flow restriction via a Delfi PTSII Tourniquet System will be used during physical therapy.
16018890|NCT02746458|Device|Delfi PTSII Tourniquet System|
16018891|NCT02746445|Other|No intervention|No intervention. This is a longitudinal study looking at subjects who received MeRT treatment.
16018892|NCT02746432|Drug|Hyper insulinemic euglycemic clamp|After obtaining a baseline preoperative lab set blood glucose value, 2 U/kg bolus of insulin (Human regular insulin) to be administered IV followed by an infusion of 2 U/ kg/min.fiver - Ten minutes after starting the insulin infusion, and when the blood glucose is <6.1 mmol /L (110 mg /dL). an Infusion of dextrose 20% supplemented with pottasium phosphate (30 mmol/L ) to be administered. In the operating room, blood glucose levels were measured every 5-15 minutes, and the dextrose infusion rate was adjusted to maintain arterial glycemia between 3.5 and 6.1 mmol/L (63-110 mg/dL). timed intra operative lab assessment to be obtained.
16018893|NCT02746419|Device|Vessix|Renal denervation using radio-ablation
16018894|NCT02746406|Device|Peritron+|Peritron+ device to measure intravesical pressure
16018895|NCT02746393|Other|Health Advocates Program|Provided services and support to address identified social needs from health advocate navigators.
16018896|NCT02746393|Other|211 Information Sheet|Receive a printed list of community resources to address social needs.
16018897|NCT02746380|Drug|LBAL|Adalimumab
16018898|NCT02746380|Drug|Humira®|Adalimumab
16018899|NCT02746367|Other|Diagnostic test (LDT)|Proteomic assay
16018900|NCT02746354|Other|The MySupport tool|Utilization of the MySupport tool, a tailored patient-centered assessment
16018901|NCT02746328|Drug|GTx-024 9 or 18 mg|Patients enrolled in G200802 receiving GTx-024 9 or 18 mg
16018902|NCT02746315|Drug|HS-20004|
16018903|NCT02746315|Drug|Placebo|
16018904|NCT02746302|Drug|HS-20004|
16018905|NCT02746302|Drug|Placebo|
16018906|NCT02746276|Drug|Ceftriaxone|Ceftriaxone is active against a broad spectrum of gram positive and gram negative bacteria, including intracellular bacteria (e.g. Salmonellae, Staphylococci). Its antibacterial effect is dependent on time above the minimum inhibitory concentration(MIC). Ceftriaxone is highly protein-bound and elimination depends on glomerular filtration rate. In severely ill adults, elimination is highly variable. Alteration in plasma proteins, volume of distribution and renal function in sick severely malnourished children could significantly alter pharmacokinetics (PK). Despite several published studies on the PK of ceftriaxone in children, none have included severe malnutrition.
16018907|NCT02746276|Drug|Metronidazole|Metronidazole is effective against Giardia, which is common amongst children with SAM; and against other anaerobic infections, including small bowel bacterial overgrowth and Clostridium difficile colitis. Small cohort studies suggest there may be benefits for nutritional recovery. However, metronidazole can cause nausea and anorexia, potentially impairing recovery from malnutrition and may also cause liver and neurological toxicity. Changes in body composition as well as metabolic and drug elimination mechanisms may alter the potential toxicity or effective dose.
16018908|NCT02746263|Drug|IV acetaminophen|
16018909|NCT02746263|Drug|Oral acetaminophen|
16018910|NCT02746263|Drug|Morphine|Patient controlled analgesia
16018911|NCT02746250|Drug|Amitriptyline|The investigator recruits patients who have already discussed and agreed to the amitriptyline treatment with their physician. The patients start the treatment after the investigator have measured them once.
16018912|NCT02746237|Drug|KAR5585 Capsules|Single and multiple ascending doses of KAR5585 (100 mg initial dose)
16018913|NCT02746237|Drug|Placebo Capsules|Single and multiple ascending doses of placebo (100 mg initial dose)
16018914|NCT02746224|Procedure|Initially dissection of inferior mesenteric vein|Laparoscopic left hemicolectomy for left colon cancer or laparoscopic low anterior resection for rectal cancer. In the group 1A the surgical technique initially dissects the inferior mesenteric vein (IMV)
16018915|NCT02746224|Procedure|Initially dissection of inferior mesenteric artery|Laparoscopic left hemicolectomy for left colon cancer or laparoscopic low anterior resection for rectal cancer. In the group 1B the surgical technique initially dissects the inferior mesenteric artery.
16018916|NCT02746224|Procedure|Latero-terminal colorectal anastomosis|The patients who will undergo a colorectal anastomosis will be included in the study 2 and will be randomized to group 2A and group 2B: in group 2A the patients will have a latero-terminal colorectal anastomosis and in group 2B a termino-terminal colorectal anastomosis.
16018917|NCT02746224|Procedure|Termino-terminal colorectal anastomosis|The patients who will undergo a colorectal anastomosis will be included in the study 2 and will be randomized to group 2A and group 2B: in group 2A the patients will have a latero-terminal colorectal anastomosis and in group 2B a termino-terminal colorectal anastomosis.
16018918|NCT02746211|Biological|High Titre Influenza virus|High Titre Influenza virus
16018919|NCT02746211|Biological|Medium - High Influenza virus|Medium - High Influenza virus
16018924|NCT02746185|Drug|rivaroxaban|rivaroxaban, 15 mg BD (Bis in die) for 3 weeks followed by 20mg OD (Omni die) for 9 weeks
16018925|NCT02746185|Drug|Low-molecular-weight heparin|dalteparin, 200 IU/kg OD for 4 weeks followed by 150 IU/kg OD for 8 weeks
16018926|NCT02746172|Device|Cochlear implant with in-situ audiometry|
16018927|NCT02746159|Device|Lutonix 035 Drug Coated Balloon PTA Catheter, Model 9004|
16018928|NCT02746146|Other|Systematic use of a prognostic score|The prognostic score is given in Dusseux et al 2015. It will be used as soon as possible after the initiation of dialysis.
16018929|NCT02746133|Other|Observational study: Supplemented protein-restricted diet|Observational study: Supplemented protein-restricted diet
16018930|NCT02746107|Other|decision aid|decision aid with one/two diagrams decision aid with risk over one/five years decision aid with CHA2DS2-VASC risk score 1 to 5 target of the prescription: patient / physician hinself
16018931|NCT02746094|Device|8 bi-weekly LIESWT sessions|"LIESWT = Low-Intensity Extracorporeal Shock Wave Therapy
~The treatment protocol consists of eight bi-weekly treatment sessions (weeks 0 ot 4). During each session 3600 shocks at 0.09 mJ/mm are applied. Shocks are applied to the penis shaft at the right corpus cavernosum and the left corpus cavernosum, and at the crura at the right crus and the left crus. 900 shocks are administered to each area. The treatment areas are the same for each session, so that at the end of the full treatment (8 sessions) each area will have received 7200 shocks at 0.09 mJ/mm.
~In general, the patient is placed on an examination table. A series of focused shockwaves produced by the electromagnetic transducer are coupled to a patient's penile shaft and crura and are made to converge along the penis/crura volume. The operator controls treatment parameters including shockwave intensity and shockwave rate.
~mJ = millijoule."
16018933|NCT02746068|Drug|AXS-02|
16018934|NCT02746068|Drug|Placebo|
16018935|NCT02746042|Drug|Sinupret extract coated tablets|1 coated tablet 3 times a day for 16-weeks (1-1-1)
16018936|NCT02746042|Drug|Placebo coated tablets|1 coated tablet 3 times a day for 16-weeks (1-1-1)
16018937|NCT02746029|Other|Clinical examination|
16018938|NCT02746016|Other|Infant Formula supplemented with Oligosaccharides|sole source nutrition
16018939|NCT02746003|Other|Managed Aquifer Recharge water|Rain water will be recharged through slow sand filter and recharge wells into the confined underground aquifer and the surrounding community will abstract the water for drinking and cooking purposes
16018940|NCT02745990|Drug|Recombinant human erythropoietin|rhEPO is administered 500IU/kg, intravenously within 72h after birth, and every other day up to 32 weeks of corrected age.
16018941|NCT02745990|Drug|Normal saline|Normal salin is administered the same volume with rhEPO intravenously within 72h after birth, and every other day up to 32 weeks of corrected age..
16018942|NCT02745977|Other|Dairy Free Diet|Dairy Free Diet x 3 stool guaiacs. If positive, dairy is reintroduced to diet.
16018943|NCT02745964|Device|LMA supreme|Anesthesia is maintained using LMA supreme in LMA supreme group or using I-gel in I-gel group according to the randomly allocated groups.
16018944|NCT02745964|Device|I-gel|Anesthesia is maintained using LMA supreme in LMA supreme group or using I-gel in I-gel group according to the randomly allocated groups.
16018945|NCT02745951|Other|Heliox|Half of the study population will be randomly assigned to receive cardioplegia enriched with a 70:30 (Helium:Oxygen) via a D100 pediatric oxygenator. The Heliox itself will need to be administered via an oxygen regulator using a low flowmeter.
16018946|NCT02745951|Other|Standard of care|The other half will be randomized to Nitrogen:Oxygen mixture. This will be done through the standard of care cardioplegia apparatus. There will be no novel interventions administered in this group.
16018947|NCT02745925|Drug|Ibuprofen|
16018948|NCT02745912|Drug|Naltrexone/Bupropion|Naltrexone/Bupropion extended-release tablets.
16018949|NCT02745912|Drug|Metformin|Metformin immediate-release tablet.
16018950|NCT02745899|Dietary Supplement|Cow milk|Ingestion of 240 ml cow milk
16018951|NCT02745899|Dietary Supplement|Soy milk|Ingestion of 240 ml soy milk
16018952|NCT02745886|Drug|metformin 0.85 twice daily for 6 months|
16018953|NCT02745886|Behavioral|Calorie restriction|
16018954|NCT02745873|Drug|Ascorbic Acid|Ascorbic Acid (vitamin-c) 500 mg in tablet form was used.
16018955|NCT02745860|Drug|Selexipag (adult formulation)|One selexipag film-coated tablet of 200 µg
16018956|NCT02745860|Drug|Selexipag (pediatric formulation)|Four selexipag film-coated tablets of 50 µg
16018957|NCT02745847|Radiation|Re-irradiation with SBRT|Patients previously treated with SBRT with relapsed pancreatic cancer will be re-irradiated with SBRT.
16018958|NCT02745834|Other|Gait analysis|Gait will be analysed while participants will walk on a treadmill at different self selected speeds, using the OPTOGait system. Spatiotemporal measures are collected without the use of any markers.
16018959|NCT02745821|Device|Pressure Wire Certus, St. Jude Medical, USA|FFR. CFR and IMR will be measured using the Pressure Wire Certus, St. Jude Medical, USA in target and non-target vessels. Changes in FFR, CFR and IMR post PCI of target vessels will also be recorded.
16018960|NCT02745808|Biological|HUC-MSCs|The subjects will receive intracavernous injection of HUCMSC.
16018961|NCT02745808|Biological|Injectable Collagen Scaffold + HUC-MSCs|The subjects will receive intracavernous injection of the mixture of injectable collagen scaffold and HUC-MSCs.
16018962|NCT02745795|Behavioral|Motivational Interview|Three face-to-face interviews using motivational interview techniques to elicit motivation for adhesion to a diet and physical activity plan intended to loose weight. The interviews will be done at schools with three months intervals.
16018963|NCT02745795|Behavioral|Conventional Interview|Three face-to-face interviews without using motivational interview techniques to elicit motivation for adhesion to a diet and physical activity plan intended to loose weight. The interviews will be done at schools with three months intervals.
16018964|NCT02745782|Other|Observational Study|Observational Study
16018965|NCT02745769|Drug|Ramucirumab|Administered IV
16018966|NCT02745769|Drug|Merestinib|Administered orally
16018967|NCT02745769|Drug|Abemaciclib|Administered orally
16018968|NCT02745756|Procedure|Autologous Hematopoietic Progenitor Cell Transplant|Autologous Hematopoietic Progenitor Cell (HPC) Transplant (HPCT). Blood stem cells will be collected by apheresis during the induction phase as part of standard treatment. During apheresis, the participant's blood is collected into a machine that filters out the stem cells and the filtered blood is returned to their body. The stem cells will be separated by the type of protein within the cells. Only the stem cells with a protein called CD34 will be used for the stem cell transplant.
16018969|NCT02745756|Biological|KLH and Tumor Lysate Pulsed DC Vaccine|Keyhole limpet hemocyanin (KLH) pulsed dendritic cell (DC) vaccine. Post-transplant vaccine days: +14, +28, +56 (± 10 days), +84 (± 10 days). Vaccines will be administered by intradermal injection of 0.5 mL at two nodal basins.
16018970|NCT02745743|Drug|BAY1251152|Weekly infusion of BAY1251152 in 21-day cycles.
16018971|NCT02745730|Other|Glucose|
16018972|NCT02745730|Other|Fructose|
16018973|NCT02745730|Other|Sucralose|
16018974|NCT02745730|Other|Allulose|
16018975|NCT02745717|Drug|Thymoglobulin|administration of ATG 3.5mg/kg/d (Thymoglobuline®, Genzyme) intravenously for 5 days
16018976|NCT02745717|Procedure|Cord blood|transfusion of one unit of at least 4/6 HLA loci matched cord blood.
16018977|NCT02745717|Drug|Cyclosporine Oral Product|administration of cyclosporine A 5mg/kg orally, and maintain the trough serum concentration between 200ng/ml to 300ng/ml.
16018978|NCT02745704|Drug|Peginterferon alfa|peginterferon alfa-2b 80 micrograms/week or peginterferon alfa-2a 180 micrograms/week
16018979|NCT02745691|Other|Surgery|Thoracic surgery for lung cancer
16018980|NCT02745691|Other|Radiochemotherapy|Either chemotherapy or radiotherapy alone or combination of both (either subsequent or concurrent)
16018981|NCT02745691|Other|Targeted therapy|New targeted therapies for lung cancer
16018982|NCT02745691|Other|Immunotherapy|New immunotherapies for lung cancer
16018983|NCT02745678|Drug|Thermosensitive gel rectal formulation|
16018984|NCT02745665|Other|flow mediated dilation (endothelial function)|
16018985|NCT02745665|Other|ABPI|
16018986|NCT02745665|Other|Pulse wave velocity and augmentation index|
16018987|NCT02745665|Other|blood pressure|
16018988|NCT02745665|Other|ramp test|
16018989|NCT02745652|Device|pulsed electromagnetic field|it is a magnetic device for magneto-therapy, it has an appliance, motorized bed, and applicable large solenoids which can be moved in 4 different positions according to the treatment area, and the additional small solenoid for hand treatment with 30 cm diameter
16018990|NCT02745652|Device|Therapeutic ultrasound|Ultrasound is applied using a transducer or applicator that is in direct contact with the patient's skin. Gel is a medium which is used on all surfaces of the head to reduce friction and assist transmission of the ultrasonic waves
16018991|NCT02745639|Radiation|VMAT-SIB|Radiation dose prescribed to PTV2 was 45 Gy (1.8 Gy/fraction), five sessions weekly in 25 daily fractions. A simultaneous boost was delivered on PTV1 with a total dose of 57.5 Gy (2.3 Gy/fraction). Dose-volume histograms (DVHs) were calculated for the PTV1, PTV2 and OARs. Patients were treated only if the relative variations of the bone markers between the images were within 3 mm along the three spatial directions. Planning and delivery processes underwent to systematic independent-check procedures.
16018992|NCT02745639|Drug|XELOX|The prescribed concurrent chemotherapy consisted of oxaliplatin infusion 130 mg/m2 on days 1, 17, 35 and capecitabine 1650 mg/m2 daily (825 mg/m² twice daily, 5 days/week) over all the treatment. An adequate blood count was necessary to start each chemotherapy infusion. Adjuvant chemotherapy was recommended on patients with high risk factors at pathological examination and decision was left to medical oncologists discretion.
16018993|NCT02745626|Device|Appliance|Orthodontic appliance to carry out orthodontic tooth movement.
16018994|NCT02745613|Other|8 weeks of combined exercise intervention|The subjects will undergo an 8 week combined exercise intervention
16018995|NCT02745600|Device|RFA therapy simulator|Computer assisted RFA of liver tumors: Planning, simulation, and follow up,
16018996|NCT02745587|Radiation|radiotherapy|high dose external beam radiotherapy limited to the prostate(bed)
16018997|NCT02745574|Procedure|Combined maneuver|Combined maneuver (Intraperitoneal normal saline infusion and Pulmonary recruitment maneuver): the upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500 cc. We will leave the 0.9% normal saline fluid in the abdominal cavity. Then, a pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure of 60 cm H2O. The anesthesiologist held the fifth positive pressure inflation for approximately 5 seconds.
16018998|NCT02745574|Procedure|Intraperitoneal infusion|the upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500 cc. We will leave the 0.9% normal saline fluid in the abdominal cavity.
16018999|NCT02745561|Drug|Endostatins|Endostatin will be administered at a dose of 7.5 mg/m2/day concurrent with radiotherapy.
16019000|NCT02745561|Drug|Oxaliplatin|Oxaliplatin (135mg/m², d1) will be administered on Day 1 and Day 29 of radiotherapy.
16019001|NCT02745561|Radiation|Radiotherapy|Radiotherapy will be delivered with a daily fraction of 2.0 Gy to a total dose of 60 Gy over 6 weeks.
16019002|NCT02745535|Drug|Sofosbuvir/Velpatasvir/Voxilaprevir|
16019003|NCT02745522|Drug|Oxytocin|
16019004|NCT02745522|Drug|Placebo|
16019005|NCT02745509|Other|Extensive Intraoperative Peritoneal Lavage|Extensive Intraoperative Peritoneal Lavage
16019006|NCT02745496|Procedure|TRUS Biopsy|Standard of Care Treatment
16019007|NCT02745496|Procedure|TRUS/FUSION Biopsy|Interventional Treatment
16019008|NCT02745483|Device|Separable clustered electrodes|patients who signed informed consent, RFA was performed using separable clustered electrodes (Octopus®) in which, inter-tine distances can be flexibly adjusted by an operator.
16019009|NCT02745470|Drug|Lixisenatide|Colorless, transparent liquid contained in a glass prefilled syringe pen-like injection (GLP-1 receptor agonist)
16019010|NCT02745470|Other|Placebo|Normal saline injection before performing fMRI
16019011|NCT02745444|Dietary Supplement|low-calorie formula diet|
16019012|NCT02745444|Dietary Supplement|protein-restricted diet|
16019013|NCT02745431|Drug|Oxytocin|
16019014|NCT02745431|Drug|Placebo|
16019015|NCT02745405|Other|Fat Suit|Participants wear a fat suit.
16019842|NCT02739555|Device|Thermal destruction with radiofrequency or laser|
16019016|NCT02745405|Other|Control Condition|Participants wear same clothing as intervention, but in their own size.
16019017|NCT02745392|Drug|ZP-Zolmitriptan|ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system
16019018|NCT02745392|Drug|Placebo|Placebo patch(es) to match ZP-Zolmitriptan single administration delivered via intracutaneous microneedle patch delivery system (one or two patches)
16019019|NCT02745379|Procedure|BFPSCs+ DFDBA+ PRF|
16019020|NCT02745379|Procedure|DFDBA + PRF|
16019021|NCT02745366|Procedure|BFPSC+FDBA+PRF|
16019022|NCT02745366|Procedure|FDBA+PRF|
16019023|NCT02745353|Drug|naloxegol|
16019024|NCT02745340|Other|Acetate by Citrate substitution and vice versa|substitution of acetate by citrate in dialysis fluid
16019025|NCT02745314|Other|Frailty measurement|Frailty measurement under Fried at el criteria
16019026|NCT02745314|Other|Comprehensive Geriatric Assessment|Multidimensional Geriatric Assessment
16019027|NCT02745301|Other|Collection of urine and bladder tumor specimens|Voided urine (pre- and post surgical) and intraoperative bladder tumor specimens to be processed for the presence of specific biomarkers.
16019028|NCT02745288|Procedure|inferior alveolar nerve block|"A long acting local anaesthetic agent Inj Bupivacaine hydrochloride 0.5% (2 ml) will be given after induction by open mouth technique by landmark method.
~The mucobuccal fold will be palpated and traced till coronoid notch. The finger will be moved medially across the retromandibular trigone on internal oblique ridge. The 25G needle will be inserted till bone is felt. 2 ml of 0.5% bupivacaine will be injected slowly after withdrawing needle by 1mm and confirming negative aspiration of blood."
16019029|NCT02745275|Behavioral|Peer-led Health Education|Peer-led health education
16019030|NCT02745262|Other|Collect retrospectively the follow-up data|Collect retrospectively the follow-up data. Each patient is called in order to request data authorization, to complete and track information.
16019031|NCT02745249|Behavioral|Maternal Nutrition Behavior change|
16019032|NCT02745236|Other|Nurse Practitioner Led-Care|Diagnosis and treatment plan decisions will be determined by Nurse Practitioner Led-Care.
16019033|NCT02745236|Other|Cardiologist Led-Care|Diagnosis and treatment plan decisions will be determined as per usual care by the Cardiologist
16019034|NCT02745223|Drug|PresbiDrops (CSF-1)|PresbiDrops (CSF-1) is a topical ophthalmic drug.
16019035|NCT02745223|Drug|Placebo|Placebo drops contains the same ingredients as PresbiDrops except for the active ingredients.
16019036|NCT02745210|Diagnostic Test|13C magnetic resonance spectroscopy|acquisition of 13C MR spectroscopy in the brain
16019037|NCT02745197|Dietary Supplement|Nutritional Supplement|Participants will take 2 capsules, containing the nutritional supplement, 3 times per day.
16019038|NCT02745197|Dietary Supplement|Placebo|Participants will take 2 capsules, containing a placebo, 3 times per day.
16019039|NCT02745184|Biological|Lung stem cells|Patients will receive 10^6 (1 million) /Kg/person cells of clinical grade lung stem cells (LSCs) injected via fiberoptic bronchoscopy after fully lavage of the localized lesions.
16019040|NCT02745171|Other|physical therapy|Will be held 15 sessions, 2 times a week, lasting 50 minutes, a physical therapy protocol developed by the Pro-Parkinson Physiotherapy based on the Guide of the Dutch Society of Physiotherapy (Keus, 2004).
16019041|NCT02745145|Drug|Abituzumab 1500 mg|Participants received Abituzumab 1500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
16019042|NCT02745145|Drug|Abituzumab 500 mg|Participants received Abituzumab 500 mg administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
16019043|NCT02745145|Drug|Placebo|Participants received Placebo matched to Abituzumab administered as an intravenous infusion for 1 hour every 4 weeks up to Week 64.
16019044|NCT02745132|Other|Neuropsychological evaluation and Brain MRI|"This is a prospective study. The only intervention planned will consist of performing neuropsychological tests and cerebral MRI that will be carried out on a single group cohort at different times.
~Notwithstanding, we will record the exposure to DAA to assess any change in neurocognitive function and MRI imaging.
~Anti-HCV regimens will be used according to clinical practice as indicated into the current guidelines (1)
~(1)European Association for Study of Liver. EASL Recommendations on Treatment of Hepatitis C 2015. J Hepatol. 2015 Jul;63(1):199-236. doi: 10.1016/j.jhep.2015.03.025. Epub 2015 Apr 21. PubMed PMID: 25911336."
16019045|NCT02745119|Drug|Lampalizumab|Lampalizumab 10 mg will be administered every 4 or 6 weeks according to the frequency given during participation in the parent study.
16019046|NCT02745106|Procedure|Radiofrequency pulmonary artery denervation|Radiofrequency ablation of pulmonary artery will be performed with standard electrophysiological catheter and non-fluoroscopic 3D-navigation system. Right heart catheterization (thermodilution method with Swan-Ganz catheter) will be performed before and after procedure. The radiofrequent impact will be performed 2mm after pulmonary artery bifurcation in both right and left main pulmonary artery branches. The radiofrequent impact will be performed at temperature 40-42 C, up to 12 watts and 60 second duration in every ablation point under impedance control.
16019047|NCT02745106|Device|Ablation catheter|4MM RF CONDUCTR (MULTI-CURVE) SERIES ABLATION CATHETER Standart procedure for radiofrequency ablation: Radiofrequency ablation of pulmonary artery will be performed with standard electrophysiological catheter and non-fluoroscopic 3D-navigation system. Right heart catheterization (thermodilution method with Swan-Ganz catheter) will be performed before and after procedure. The radiofrequent impact will be performed 2mm after pulmonary artery bifurcation in both right and left main pulmonary artery branches. The radiofrequent impact will be performed at temperature 40-42 C, up to 12 watts and 60 second duration in every ablation point under impedance control.
16019048|NCT02745106|Device|Swan-Ganz catheter for right heart catheterization|"Standart procedure of right catheterization:
~punction of right jugular vein with Seldinger technique, introducer placement
~insertion of Swan-Ganz catheter via introducer in jugular vein under fluoroscopic control and wave form of monitor's curve.
~positioning of swan-ganz catheter in pulmonary artery
~direct central hemodynamics measurements: systolic/diastolic/mean pulmonary artery pressure, pulmonary capillary wedge pressure, cardiac output (thermodilution technique)
~calculating of indirect parameters (pulmonary vascular resistance)"
16019049|NCT02745093|Drug|Mifepristone|Women at 64-84 days' gestation will use the following dosing regimen: 200 µg mifepristone administered orally in the clinic on Day 1.
16019524|NCT02741778|Procedure|Open group|Right lateral position, Traditional thoracotomy through the 7th intercostal incision.
16019050|NCT02745093|Drug|Misoprostol|The client will then be given a total of 2400 µg misoprostol tablets to take home, and will be instructed to take 800 μg misoprostol administered sublingually 24-48 hours later at home and to administer a subsequent dose of 400 μg misoprostol sublingually every 3 hours up to a total of four further doses or until expulsion of the products of conception, whichever comes first.
16019051|NCT02745080|Biological|Secukinumab|Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio
16019052|NCT02745080|Biological|Adalimumab|Eligible subjects are randomized to one of two treatment arms in a 1:1 ratio
16019053|NCT02745067|Behavioral|enhanced cognitive behavioral therapy|
16019054|NCT02745054|Other|mgt of bleeding concerns/complications of oral anticoagulants|observational study of clincians' management of patients taking oral anticoagulants and having acute significant bleeding or requiring management of bleeding risk before an emergent procedure; observation limited to index hospitalization only
16019055|NCT02745041|Drug|Fibrinogen Concentrate|"Fibrinogen Replacement using Fibrinogen Concentrate as per ROTEM guided treatment algorithm [FIBTEM ≤ A5 10mm]
~FIBTEM A5 0mm (Flat Line) = 6g FC FIBTEM A5 1 - 4mm = 5g FC FIBTEM A5 5 - 6mm = 4g FC FIBTEM A5 7 - 8mm = 3g FC FIBTEM A5 9 - 10mm = 2g FC"
16019056|NCT02745041|Other|Cryoprecipitate|"Fibrinogen replacement using Cryoprecipitate as per ROTEM guided treatment algorithm [FIBTEM A5 ≤ 10mm]
~FIBTEM A5 0mm (Flat Line) = 20 Units Cryo FIBTEM A5 1- 4mm = 16 Units Cryo FIBTEM A5 5 - 6mm = 14 Units Cryo FIBTEM A5 7 - 8mm = 10 Units Cryo FIBTEM A5 9 - 10mm = 8 Units Cryo"
16019057|NCT02745028|Dietary Supplement|Monosodium glutamate|A single dose of weight adjusted monosodium glutamate will be added at the time of a repeat radionuclide gastric emptying study
16019058|NCT02745015|Procedure|non-surgical periodontal treatment|full-mouth scaling and root planing
16019059|NCT02745002|Device|navigated bronchoscopy|
16019060|NCT02744989|Device|Neuroconn or Neuroelectric tDCS stimulator|Stimulation parameters were chosen in conformity with those for the treatment of schizophrenic symptoms (Brunelin et al, 2012), adapted according to the latest data from the literature and the tDCS operating stimulator. The experimental group will receive the active stimulation: Intensity = 2 mA. Sequence duration = 20 minutes (ramp ud/ramp down 30 seconds). Total number of sessions = 10 (sessions twice daily for 5 days)
16019061|NCT02744989|Device|Sham tDCS|The control group will receive the sham stimulation (placebo) following the same regimen. Sham stimulation consists of a 20 minutes session including 1 minute active stimulation (ramp up/ramp down 30 seconds, 2 mA) at the beginning and ending of the sessions.
16019062|NCT02744976|Drug|Metformin|In order to minimize gastrointestinal discomfort, metformin treatment will be started with a dose of 500 mg p/o once daily, then gradually increased to 2000 mg p/o once daily for 24 months
16019063|NCT02744976|Behavioral|Lifestyle recommendations|Standard lifestyle recommendations
16019064|NCT02744963|Other|Free and convenient medicine access|
16019065|NCT02744950|Procedure|Pulley stitches|
16019066|NCT02744950|Procedure|Intermediate Repair|
16019067|NCT02744937|Drug|Aspirin|aspirin is continued by its regular dosing
16019068|NCT02744924|Behavioral|Physical activity intervention|"The intervention is comprised of 5 steps:
~Goal setting: Over a step-counter (smartphone app) participants learn about their daily average step count. They are coached to set individual goals
~Fitness assessment: To recommend suitable frequency and intensity of walking program using mapped trails
~Structured walking groups: Promoted and communicated via app. Participants can additionally organize walking groups of their own.
~Feedback: Participants will see individual and group data over the step-counter app, and they can communicate with others via a communication app. They will be incentivized to reach goals through a gamification approach.
~Invite friends: After 12 weeks, participants are encouraged to invite people who fulfil the inclusion criteria to join the project"
16019069|NCT02744911|Device|SpeechVive device|The SpeechVive is a wearable device that plays multi-talker babble noise in one ear while the person wearing it is talking. The noise is voice-activated (only present when the person speaks). The noise does not interfere with the ability to hear communication partners. The noise coming from the device functions as a natural external cue for people with Parkinson's disease to talk more loudly and clearly. Treatment will involve asking the participants to wear the device daily during the treatment period.
16019070|NCT02744911|Behavioral|Telemedicine interaction|Participants will interact with the speech-language pathologist using the telemedicine platform from their home.
16019071|NCT02744911|Behavioral|In person interaction|Participants will interact with the speech-language pathologist in-person at the speech pathologist's office
16019072|NCT02744898|Drug|Carboplatin AUC|
16019073|NCT02744898|Drug|Abraxane|100mg/m2
16019074|NCT02744885|Dietary Supplement|Crave Crush|Crave Crush is a dietary supplement that affects sweet taste receptors on the tongue.
16019075|NCT02744885|Dietary Supplement|Placebo Comparator: Placebo|The placebo tablet is comparable in taste and is comprised primarily of sorbitol.
16019076|NCT02744872|Drug|Felodipine|Felodipine 10 mg once daily or identical placebo
16019077|NCT02744872|Drug|Placebo|Placebo
16019078|NCT02744859|Other|Label Condition|Labels will be presented in front of drinks. We will vary the messaging presented to the consumer.
16019079|NCT02744846|Drug|Antibiotics exposure|
16019080|NCT02744833|Drug|GMI-1271|
16019081|NCT02744833|Drug|Enoxaparin Sodium (Lovenox®)|
16019082|NCT02744820|Drug|GMC-252-L-Lysine Salt|1 dose by oral route, once a day, 28 days
16019083|NCT02744820|Other|Placebo|Matching doses by oral route, once a day, 28 days
16019084|NCT02744807|Other|Chronic endometritis|with or without Chronic endometritis
16019085|NCT02744794|Device|Dermal Cooling System|Treatment with cryotherapy.
16019086|NCT02744781|Device|Lumbar disc degeneration; LDD|All MR images, taken at 5 lumbar intervertebral disc levels from the first lumbar (L1) vertebra to the first sacral vertebra (S1), were independently evaluated by 2 experienced orthopedic specialists in a random order using a grading system for LDD assessment. Using a comprehensive grading system for LDD, discs were classified into 5 grades, as described by Pfirrman et al. This system uses characteristics of disc structure, distinction between the nucleus and annulus, MRI signal intensity, and intervertebral disc height for grading, and has been accepted as a standardized and reliable evaluation tool for assessment of MRI disc morphology.
16019525|NCT02741765|Behavioral|Sham rTMS|Subjects will participate in daily sessions of sham-rTMS
16019087|NCT02744768|Drug|Dasatinib|Adult Ph+ ALL (≥18 years old, with no upper age limit) patients will begin treatment with Dasatinib, 140 mg/day, from day 1 to day +84.
16019088|NCT02744768|Drug|Blinatumomab|"Upon induction:
~patients in CHR will receive Blinatumomab at a dose of 15 µg/m²/day as continuous intravenous infusion (CIVI) at a constant flow rate for four weeks, followed by a two-week infusion-free interval, defined as one treatment cycle. At least 2 cycles should be administered, up to a maximum of 5 cycles, if deemed necessary."
16019089|NCT02744755|Biological|Adalimumab - GP2017|Adalimumab - GP2017
16019090|NCT02744755|Biological|Adalimumab - US licensed Humira|Adalimumab - US licensed Humira
16019091|NCT02744742|Drug|Decitabine|Decitabine was administered at 20mg/m2/day on days -14 and -10.
16019092|NCT02744742|Drug|Busulfan (BU)|Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.
16019093|NCT02744742|Drug|Cyclophosphamide (CY)|Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
16019094|NCT02744742|Drug|Granulocyte Colony-Stimulating Factor(G-CSF)|G-CSF was administered at 5-10 ug/kg/day on days -17 and -10. When white blood cell is more than 20G/L, stop using G-CSF.
16019095|NCT02744729|Drug|99mTc-3PRGD2|For patients in suspicion of esophagus cancer, single intravenous bolus injection of nearly 11.1 MBq/kg body weight of 99mTc-3PRGD2 on day one of the treatment period, whole-body planar and thoracic SPECT/CT to determine the accumulation of 99mTc-3PRGD2 in the tumors and the other parts of the body.
16019096|NCT02744716|Drug|Aspirin|low dose of Aspirin after operation
16019097|NCT02744716|Device|intrauterine balloon|insert intrauterine balloon after operation
16019098|NCT02744703|Drug|total-etch adhesive|comparator use of total-etch adhesive
16019099|NCT02744703|Drug|CAPE-T|experimental group
16019100|NCT02744703|Drug|self-etch adhesive|comparator use of total-etch adhesive
16019101|NCT02744703|Drug|CAPE-S|experimental group
16019102|NCT02744690|Drug|Mitomycin-C (MMC)|Mitomycin-C is routinely applied to the eye prior to trabeculectomy at Menelik II Hospital
16019103|NCT02744677|Device|SAPIEN 3 THV|SAPIEN 3 THV in the pulmonic position
16019104|NCT02744664|Procedure|Cryotherapy|After entering the group subject receive Cryotherapy on lung cancer
16019105|NCT02744664|Drug|Icotinib|After Cryotherapy, subjects begin Icotinib administration
16019106|NCT02744651|Device|EUS-FNA|"Please note the text in section Arm description"
16019107|NCT02744651|Device|EUS-Endodrill biopsy|"Please note the text in section Arm description"
16019108|NCT02744638|Other|probiotic yoghurt|verum is a liquid probiotic yoghurt containing all four probiotics as described in the arm description. Study participants consume daily two bottles (125g) during an intervention period of four weeks.
16019109|NCT02744638|Other|chemically acidified milk|Placebo is chemically acidified milk without bacterial strains. Study participants consume daily two bottles (125g) during an intervention period of four weeks (randomly assigned).
16019110|NCT02744638|Drug|Arilin|2 tablets Arilin 500mg for 7 days
16019111|NCT02744625|Drug|Higher doses of vasopressor therapy for a MAP of 75 mmHg|
16019112|NCT02744625|Drug|Lower doses of vasopressor therapy for a MAP of 65 mmHg|
16019113|NCT02744625|Drug|Propofol for light sedation|Propofol for light sedation
16019114|NCT02744612|Drug|Brentuximab Vedotin|Given IV
16019115|NCT02744612|Drug|Ibrutinib|Given PO
16019116|NCT02744599|Device|Prompting breaths via recorded voice, vibrating massager, and/or muscle tetany|Prompt volunteer to breathe using device to play recorded voice, massage the body, and/or apply muscle tetany
16019117|NCT02744586|Behavioral|Strengthening Our Vows (SOV)|"Participants, led by a counselor, will discuss options to keep HIV from entering their relationship including both sex partners remaining monogamous, using condoms every time they have sex with outside partners, and being tested together with outside partners to ensure they are HIV negative (Together HIV Free Plan). Participants will discuss options in the event of an outside exposure to HIV including abstaining from having sex with their spouse or by using condoms every time they have sex with their spouse until they can be retested for HIV after 30 days (Protecting my Spouse Plan).
~Participants will be screened for hypertension, diabetes, schistosomiasis, HIV, syphilis, and trichomonas vaginalis and the presence of sperm (women only). Health problems will be treated or referred. Couples will be administered questionnaires that record self-report of sexually transmitted infections, number of outside partners, and reports of sex without a condom with outside partners."
16019118|NCT02744586|Behavioral|Good Health Package Plus (GHPP)|Participants, led by a counselor, will discuss how to prevent, screen, and treat neglected tropical diseases (helminths and schistosomiasis), non-communicable diseases (hypertension and diabetes) and diarrheal diseases through basic hygiene and sanitation. The facilitator will demonstrate proper handwashing techniques and chlorination of water and discuss diet and lifestyle changes. Participants will be screened for hypertension, diabetes, schistosomiasis, HIV, syphilis, and trichomonas vaginalis and the presence of sperm (women only). Health problems will be treated or referred. Couples will also be administered questionnaires that record self-report of sexually transmitted infections, number of outside partners, and reports of sex without a condom with outside partners.
16019119|NCT02744560|Dietary Supplement|spirulina|Spirulina in a dose of 250 mg/kg/day will be given orally for 3 months.
16019120|NCT02744547|Dietary Supplement|Spirulina|Spirulina in a dose of 250 mg/kg/day will be given orally for 3 months.
16019121|NCT02744534|Drug|FACBC PET-CT Scan|"One hour prior to scanning, participants will drink one glass (450 ml) of oral contrast to allow for better pictures of abdomen and pelvic organs. The participants will have their temperature taken before and after the injection of the FACBC. Blood pressure and pulse will be taken every 15 minutes during the PET scan.
~Participants will lie on a scanning bed and the bed will move slowly through the PET/CT scanner. This portion usually takes about one minute. Following this the FACBC will by administered by an intravenous (IV) catheter and the PET scan portion of the exam will begin. The table moves slowly through the scanner and many sets of PET-CT images are produced. When the imaging is complete, the scanner will send the results to a computer. The computer then generates a number of images that will be reviewed by a specially trained radiologist."
16019154|NCT02744300|Behavioral|BABI-2 Lifestyle Intervention|Participants in this intervention will receive support from a lifestyle coach and gain access to a website with online presentations that contain healthy eating and physical activity educational tips.
16019526|NCT02741765|Other|Real rTMS|Subjects will participate in a combination of rTMS
16019122|NCT02744534|Procedure|Three-dimensional ultrasound-guided biopsy|"A lubricated rectal probe will be inserted and a local anesthetic to numb the prostate will be administered. The ultrasound probe allows visualization of the prostate in two-dimensional (2D) images. The probe connects to a computer that will link to the FACBC PET-CT scan results that the participant has already had performed. These combined images will provide a three-dimensional (3D) image from the FACBC PET-CT scan previously obtained as well as real-time, 2D ultrasound images, resulting in an improved visualization tool to target the biopsy needle to a suspicious lesion.
~The needle tip position for each biopsy sample will be recorded on the real-time ultrasound images; this information allows the physician to either re-biopsy the same area for a follow-up examination or not to re-biopsy the same region if the original biopsy was negative.
~This biopsy process is estimated to take about 10 minutes."
16019123|NCT02744534|Procedure|Standard transrectal ultrasound (TRUS) guided biopsy|A lubricated ultrasound probe of about 2.5 cm in diameter is gently inserted into the rectum and a local anesthetic to numb the prostate is administered. The ultrasound probe allows visualization of the prostate in two-dimensional (2D) images and allows for the placement of a biopsy needle that collects samples of the prostate. Usually, a total of 12 biopsy specimens are collected. The procedure takes about 20 minutes. This TRUS-guided biopsy is considered as the standard method for prostate cancer diagnosis.
16019124|NCT02744521|Other|Symptom-based screening intervention|The objective of this study is to evaluate whether empowering and involving inmate peer educators in TB control has an impact on increasing TB case detection rate and improving treatment success in resource-limited prison settings. In this interventional study, inmate peer educators will be trained about TB, its prevention, and control. Once tested for their capability, peer educators will then provide education about TB, its prevention and control for their fellows every two weeks on a regular basis for one year. They will also undertake routine TB screening using a standardized TB screening protocol to identify presumptive TB cases for a referral.
16019125|NCT02744508|Drug|palonosetron|
16019126|NCT02744508|Drug|palonosetron with dexamethasone|
16019127|NCT02744495|Drug|Betamethasone|Prophylaxis if risk score is over 2. Prophylaxis of postoperative nausea and vomiting by betamethasone / Celestene (4mg) and/or droperidol / Droleptan (0.625mg) immediately after cardiac surgery, depending on risk factors in the intervention arm.
16019128|NCT02744495|Drug|Droperidol|Prophylaxis if risk score is over 2. Prophylaxis of postoperative nausea and vomiting by betamethasone / Celestene (4mg) and/or droperidol / Droleptan (0.625mg) immediately after cardiac surgery, depending on risk factors in the intervention arm.
16019129|NCT02744482|Drug|risedronate|risedrante tablet (75 mg)
16019130|NCT02744482|Drug|placebo|risedrante placebo tablet (75 mg)
16019131|NCT02744469|Other|No intervention (observational study)|
16019132|NCT02744456|Drug|Losartan|An angiotensin II receptor antagonist drug used mainly to treat high blood pressure.
16019133|NCT02744456|Drug|Amlodipine|A calcium channel blocker and may be used alone or in combination with other antihypertensive and antianginal agents for the treatment of hypertension.
16019134|NCT02744456|Drug|Hydrochlorothiazide|A diuretic medication often used to treat high blood pressure and swelling due to fluid build up.
16019135|NCT02744443|Dietary Supplement|Leucine|
16019136|NCT02744443|Dietary Supplement|Placebo|
16019137|NCT02744430|Drug|Mirabegron|Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus >5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet.
16019138|NCT02744430|Other|Placebo|Randomized 1:1 ratio using a randomized block design, stratified by stone size (≤5 mm versus >5 mm) and location (upper versus lower ureter). The randomization will be implemented through a database with software designed by the Director of Research Informatics at the Baylor College of Medicine's Dan Duncan Institute of Clinical and Translational Research. It will be a HIPPA-compliant secure database accessible via internet.
16019139|NCT02744417|Behavioral|Smoking cessation counseling|Multidisciplinary smoking cessation counseling, performed by a team comprising physicians, nurses, a psychologist and dentists. It consisted of four 1-h counselling lectures delivered by physicians, psychologist-assisted cognitive behavioural therapy, and counseling provided by dentists during the active phase of the treatment and maintenance session, using motivational interviewing techniques
16019140|NCT02744417|Procedure|Non-surgical periodontal therapy|Full-mouth supra and subgingival scaling and root planing (with curettes and ultrasonic scaler); oral hygiene instruction and motivation and removal of intra-oral plaque retentive factors
16019141|NCT02744417|Drug|Nicotine replacement therapy|Nicotine replacement therapy: chewing gum (Nicorette chewing gum 2-4mg) and patches (Nicorette patches 15-25mg)
16019142|NCT02744417|Drug|bupropion hydrochloride|bupropion hydrochloride 150mg
16019143|NCT02744417|Drug|Varenicline|Varenicline 0,5mg
16019144|NCT02744404|Device|POC EID|
16019145|NCT02744391|Drug|Levodopa|
16019146|NCT02744378|Drug|Tacrolimus 0.1%|This group was randomly allocated to receive topical Tacrolimus 0.1% for 3 consecutive weeks
16019147|NCT02744378|Drug|Clobetasol 0.05%|This group was randomly allocated to receive topical Clobetasol 0.05% for 3 consecutive weeks
16019148|NCT02744365|Other|Observational|"All women of the biobank have provided:
~blood samples (plasma, serum and Buffy-coat)
~urine samples
~demographic and clinical data (maternal age, BMI, smoking status, obstetrical and medical history)
~mean arterial blood pressure
~ultrasound examination (datation of pregnancy at recruitment, uterine arteries doppler, placental volume, nuchal translucency in the majority of the cases)
~access to medical record (for pregnancy/delivery outcomes, newborn birthweight, gestational age at delivery)"
16019149|NCT02744352|Drug|20ml bolus of 0.5% ropivicaine|Local anesthetic
16019150|NCT02744352|Drug|0.2% of ropivacaine at 8 milliliter/hour|Local anesthetic
16019151|NCT02744339|Drug|Riociguat|Adempas up-titrated to max. 1.5mg TID
16019152|NCT02744339|Drug|Placebo|Placebo sham-titrated TID
16019153|NCT02744326|Behavioral|Text message reminders|Patients assigned to the intervention group will receive a series of 7 to 10 text message reminders to schedule or attend their follow-up appointment.
16019360|NCT02743013|Drug|CHF 5993 100/6/12,5 pMDI with Valved Holding Chamber|
16019361|NCT02742987|Drug|Ticagrelor|Ticagrelor 90 mg twice daily
16019155|NCT02744287|Biological|BPX-601|Autologous T cells genetically modified with retrovirus vector containing PSCA-specific CAR and an inducible MyD88/Cluster Designation (CD)40 (iMC) co-stimulatory domain
16019156|NCT02744287|Drug|Rimiducid|Dimerizer infusion to activate the iMC of the BPX-601 cells for improved proliferation and persistence
16019157|NCT02744274|Other|Verum acupuncture|"Patients will lay supine. The acupuncture physicians will disinfect the selected acupuncture points with alcohol and then needle them (30 gauze, 1.5-inch, Yuguang, Taiwan) with a plastic device is fixed needle body, so that the patient achieves a de qi sensation, which is often described as a pressure or achiness feeling. The acupuncture point will be bilateral Quchi, Waiguan, hegu, baxie, Zusanli, Yanglingquan, Sanyinjiao, Taichong, bafeng. Acupuncture needles will be left in place for approximately 30 minutes, and every 10 minutes twisting stainless steel needle to get a de qi."
16019158|NCT02744248|Drug|IOP Injection|IOP Injection 20 mg Fe/ml, intravenous injection
16019159|NCT02744248|Drug|0.9% normal saline|0.9% normal saline 10 ml, intravenous injection
16019160|NCT02744235|Device|Polysomnography Data|
16019161|NCT02744235|Device|Jawbone UP®|
16019162|NCT02744235|Device|Fitbit Charge ®|
16019163|NCT02744222|Biological|BCD-054 180 mcg|180 mcg intramuscularly once every two weeks
16019164|NCT02744222|Biological|Avonex®|30 mcg intramuscularly once a week
16019165|NCT02744222|Biological|BCD-054 240 mcg|240 mcg intramuscularly once every two weeks
16019166|NCT02744222|Other|Placebo|intramuscularly once a week (0,5 ml)
16019167|NCT02744196|Biological|Acellbia|Acellbia is rituximab biosimilar, monoclonal antibody which binds CD20.
16019168|NCT02744196|Drug|Placebo|Placebo solution will look identical to the Acellbia solution.
16019169|NCT02744196|Drug|Methotrexate|
16019170|NCT02744183|Behavioral|Exercise|Moderate intensity exercise
16019171|NCT02744183|Behavioral|Breakfast|Breakfast consumption
16019172|NCT02744183|Behavioral|Maintain habitual habits|Normal physical activity and dietary behaviors maintained
16019173|NCT02744170|Device|1 continuous flow oxygen supplementation|This oxygen Supplementation is used in special order
16019174|NCT02744170|Device|2 demand delivery liquid oxygen supplementation|This oxygen Supplementation is used in special order
16019175|NCT02744170|Device|3 demand delivery oxygen supplementation via concentrator|This oxygen Supplementation is used in special order
16019176|NCT02744157|Behavioral|Longterm effects after a structured lifestyle program|present study was to describe a structured intervention to reduce cardiovascular risk in a clinical setting and to study the effects of the program on lifestyle habits and quality of life in individuals at risk after six months and one year.
16019177|NCT02744131|Drug|Oral contraceptive pill combination of ethyl estradiol and Cyproterone acetate|
16019178|NCT02744131|Drug|Metformin 1500mgs per day|
16019179|NCT02744118|Other|5A's Model|"The adapted 5A's model will include the following elements:
~Ask the patient about their marijuana use
~Advise every patient to quit/reduce marijuana use using clear, specific personalized advice
~Assess factors affecting choice of behavior and behavior change
~Assist abstinence/reduction in in marijuana use using behavior change techniques to aid the patient
~Arrange follow-up for ongoing assistance and support, and to adjust treatment plans"
16019180|NCT02744118|Other|Healthy Internet Use Model|"The Healthy Internet Use Model provides a framework for conversations between pediatric practitioners and their adolescent patients. It focuses on 3 key areas of social media behavior:
~Balance
~Boundaries
~Communication"
16019181|NCT02744105|Dietary Supplement|Spirulina|Spirulina in a dose of 250 mg/kg/day will be given orally for 3 months.
16019182|NCT02744092|Drug|Rivaroxaban|Anticoagulation therapy.
16019183|NCT02744092|Drug|Apixaban|Anticoagulation therapy.
16019184|NCT02744092|Drug|Edoxaban|Anticoagulation therapy.
16019185|NCT02744092|Drug|Dabigatran|Anticoagulation therapy.
16019186|NCT02744092|Drug|Warfarin|Anticoagulation therapy.
16019187|NCT02744092|Drug|Dalteparin|Anticoagulation therapy.
16019188|NCT02744092|Drug|Enoxaparin|Anticoagulation therapy.
16019189|NCT02744092|Drug|Fondaparinux|Anticoagulation therapy.
16019190|NCT02744079|Behavioral|Low carbohydrate diet|45 subjects will be randomized to a dietary arm consisting of a complete, prepared very low carbohydrate diet, delivered to their homes, for the interval between positive breast biopsy and surgical tumor removal
16019191|NCT02744079|Behavioral|Low fat diet|20 subjects will be randomized to a dietary arm consisting of a complete, prepared low fat diet, delivered to their homes, for the interval between positive breast biopsy and surgical tumor removal.
16019192|NCT02744066|Device|NEATCAP|Neonates will be sized and fitted to wear the non-invasive novel hearing protection device over a set period of time in the NICU. Vitals will be monitored.
16019193|NCT02744053|Procedure|Dynamic Contrast-Enhanced Magnetic Resonance Imaging|Undergo DCE-MRI
16019194|NCT02744053|Other|Laboratory Biomarker Analysis|Correlative studies
16019195|NCT02744053|Radiation|Scintimammography|Undergo MBI
16019196|NCT02744053|Drug|Technetium Tc-99m Sestamibi|Given via injection
16019197|NCT02744040|Drug|ART initiation at time of HIV diagnosis|Immediate ART initiation
16019198|NCT02744040|Drug|ART at 24 weeks|ART initiation 24 weeks after enrollment
16019199|NCT02744027|Other|Dynamic Contrast Enhanced Magnetic Resonance Lymphangiography (DCMRL)|Following completion of the T2 lymphatic mapping, contrast agent administered will be calculated based on weight. Investigators will use dosage of 0.1cc/kg of contrast which will be injected by hand simultaneously into each lymphatic node (LN) at a rate of 0.5-1 cc per min. One minute after the injection, scanning will be initiated using high spatial and temporal resolution magnetic resonance angiography (syngo time-resolved angiography with stochastic trajectories [TWIST]) sequence. The sequence parameters will be adjusted with a time delay such that a complete volume will be acquired approximately every 20-60 seconds. This will be followed by additional scans with a high-resolution navigator gated 3-dimensional flash inversion recovery (IR) sequence. In all subjects the scan area covered the neck, chest, and abdomen as caudal as feasible.
16019200|NCT02744027|Other|Heavy Weighted T2 Imaging (T2W)|Magnetic Resonance imaging (MRI) will be performed and T2W MRI lymphatic mapping will be performed using a respiratory navigated and cardiac gated 3 dimensional turbo spin echo sequence with pre-set parameters. Scan time varies from 2-5 min depending upon the size of the subject.
16019201|NCT02744027|Other|Lymph Node Access|"The procedure will be performed under sedation and anesthesia if participants are aged 16 or under. The procedure will be performed with local anesthesia for participants aged over 16 years old.
~Using ultrasound guidance two inguinal lymph nodes (one each side) will be directly accessed with 25-gauge spinal needles attached to a short connector tubing. A shallow angle for puncture will be used to create a long subcutaneous tract to assist in stabilizing the needle. A small amount of an oil-based contrast or water soluble contrast will be injected under fluoroscopy guidance to confirm the correct position of the needles inside the lymph nodes. After stabilizing the needle, the subjects will be transferred into the MRI suite."
16019202|NCT02744014|Behavioral|Add-on Therapy for Axial Spondyloarthritis|
16019203|NCT02744001|Other|Low Added Sugar Diet|1-week intake of Low Added Sugar Diet 3 day rotating menu
16019204|NCT02743988|Drug|Oxygen|Adapt inspired oxygen to achieve desired SpO2 target range
16019205|NCT02743975|Drug|Bevacizumab-800CW|dose finding: 4.5mg; 10mg; 25mg; 50mg
16019206|NCT02743962|Device|Therapeutic Wand|The therapeutic wand will be used to apply a gentle caudad pressure on the pelvic floor, encouraging a release and gentle stretch of the muscles. The participants will follow a protocol of sweeping gently along one side then the other to find tender or tight areas, and then to apply the wand to relax and stretch the muscles for up to 5 minutes in total, twice weekly for the duration of the study.
16019207|NCT02743962|Other|Routine physiotherapy control|This group will receive standard specialist physiotherapy intervention for bladder pain syndrome as stated in the arm descriptor, and will not use the therapeutic wand.
16019208|NCT02743949|Drug|Vonoprazan|Vonoprazan over-encapsulated capsules
16019209|NCT02743949|Drug|Esomeprazole|Esomeprazole over-encapsulated tablets
16019210|NCT02743949|Drug|Esomeprazole Placebo|Esomeprazole placebo-matching capsules
16019211|NCT02743936|Device|Nasal cannula|Placement of nasal cannula under non-invasive positive pressure ventilation mask
16019212|NCT02743936|Device|Non-invasive positive pressure ventilation|Non-invasive positive pressure ventilation
16019213|NCT02743923|Drug|carboplatin|AUC 6
16019214|NCT02743923|Drug|paclitaxel|200mg/m2
16019215|NCT02743923|Drug|Bevacizumab|15 mg/kg
16019216|NCT02743923|Drug|Pemetrexed|500 mg/m2
16019217|NCT02743923|Drug|cisplatin|75 mg/m2
16019218|NCT02743910|Other|ptDNA|Pre-operative blood samples for ptDNA will be collected at the time of diagnosis/prior to NAT, post-cycle 1/pre-cycle 2 of NAT, after all NAT/immediately before surgery, and post-operatively at 6, 12, 24, and 36 months, and annually thereafter if funding allows.
16019219|NCT02743910|Other|Tissue sample|Representative tissue sample will be collected from the diagnostic biopsy (in all participants) and definitive surgery (if available)
16019220|NCT02743897|Drug|Zepatier|Zepatier (grazoprevir 100mg and elbasvir 50 mg once daily) is taken by mouth for 12 weeks unless a genetic variation is detected. In this case treatment with Zepatier will be extended to 16 weeks. Study subjects with treatment failure will be provided open-label Zepatier + sofosbuvir (sovaldi) 400mg + Ribavirin (generic), renally dosed based on creatinine clearance per the manufacturer guidelines.
16019221|NCT02743897|Drug|Mavyret|Mavyret (glecaprevir 100 mg and pibrentasvir 40 mg) is taken by mouth for 8 weeks. Study subjects with treatment failure will be provided an alternative DAA + sofosbuvir (sovaldi) 400mg + Ribavirin (generic), renally dosed based on creatinine clearance per the manufacturer guidelines.
16019222|NCT02743884|Device|Esophageal Warming|30 minutes of warming from circulating water at about 42 degrees C through an esophageal heat exchanger.
16019223|NCT02743884|Device|Esophageal Cooling|30 minutes of cooling from circulating water at about 7 degrees C through an esophageal heat exchanger.
16019224|NCT02743871|Biological|PF-06817024|Subjects will be given one dose of PF-06817024 intravenously
16019225|NCT02743871|Other|Placebo for PF-06817024|Subjects will be given one dose of placebo for PF-06817024 intravenously
16019226|NCT02743871|Biological|PF-06817024|Subjects will be given one dose of PF-06817024 subcutaneously
16019227|NCT02743871|Other|Placebo for PF-06817024|Subjects will be given one dose of placebo for PF-06817024 subcutaneously
16019228|NCT02743871|Biological|PF-06817024|Subjects will be given two doses of PF-06817024 intravenously
16019229|NCT02743871|Other|Placebo for PF-06817024|Subjects will be given two doses of PF-06817024 intravenously
16019230|NCT02743871|Biological|PF-06817024|Subjects will be given 2 doses intravenously
16019231|NCT02743871|Other|Placebo for PF-06817024|Subjects will be given 2 doses intravenously
16019232|NCT02743871|Biological|PF-06817024|Subjects will be given doses of PF-06817024 intravenously
16019233|NCT02743871|Other|Placebo for PF-06817024|Subjects will be given doses of Placebo intravenously
16019234|NCT02743858|Other|Bilateral arm measurements|Will be obtained using the Perometer (Model 350 NT Perometer, Per-System) circumferential arm measurements with elastic tape taken at 4-cm intervals from the wrist to the shoulder, and the L-Dex U400 (Impedimed, Brisbane, Australia) for bioimpedance measurements. For patients who have not yet developed lymphedema by 2 years, an additional measurement at approximately 3 years post-surgery will be performed.
16019235|NCT02743858|Other|Body mass index (BMI)|Height and weight will be obtained for each patient at baseline and at each scheduled visit for the purpose of calculating BMI. BMI will be correlated with the presence of inflammatory biomarkers in the tissue, as well as with lymphedema development.
16019236|NCT02743858|Behavioral|Quality of Life Questionnaire and COVID-19 Vaccine Information|
16019237|NCT02743832|Procedure|Resection for primary lesion and cervical lymph node dissection|Resection for primary lesion and cervical lymph node dissection are performed in the early-stage oral squamous cell carcinoma.
16019238|NCT02743832|Procedure|Resection for primary lesion|Resection for primary lesion is performed in the early-stage oral squamous cell carcinoma.
16019239|NCT02743819|Drug|Pembrolizumab|Pembrolizumab given every 3 weeks (200 mg) by IV infusion.
16019240|NCT02743819|Drug|Ipilimumab|Ipilimumab given every 3 weeks (200 mg) by IV infusion for total of 4 doses.
16019241|NCT02743806|Drug|Vedolizumab|Vedolizumab IV infusion
16019242|NCT02743793|Procedure|Blood Draw|
16019243|NCT02743780|Drug|MGV354 ophthalmic suspension|
16019244|NCT02743780|Drug|MGV354 placebo|Inactive ingredients used as placebo comparator
16019362|NCT02742987|Drug|Clopidogrel|Clopidogrel 150 mg once daily
16019245|NCT02743767|Procedure|Introducing five different treating adaptations|Immediate Bag-valve mask ventilation after administering of muscle relaxants, optimized preoxygenation, introducing of a preinterventional checklist, increased usage of video laryngoscopy and immediate hand alternately if frustrated intubation.
16019246|NCT02743754|Other|Standard therapy|The standard of care for improving oxygen delivery to the kidney. These may include blood transfusions for anemia, treatment of low blood pressure and oxygen for low blood oxygen levels.
16019247|NCT02743754|Other|Hyperbaric Oxygen|The standard of care therapies and in addition will be treated in the hyperbaric chamber within 12 hours of surgery. There will be 4 hyperbaric oxygen treatments in 48 hours (1 every 12 hours), each treatment will last 90 minutes with 100% oxygen at 2.4 ATA.
16019248|NCT02743741|Drug|Lutetium-177 Octreotate|Radiopharmaceutical
16019249|NCT02743728|Device|Magnetic Resonance Imaging|Anatomical and Diffusion Tensor Imaging Analysis.
16019250|NCT02743728|Device|Transcranial Magnetic Stimulation|Assessment of brain (cortical) excitability
16019251|NCT02743728|Behavioral|General Movement Assessment|Spontaneous movement assessment of infant while lying in unperturbed state.
16019252|NCT02743715|Device|Active tDCS (transcranial direct current stimulation)|An electrical current of 2mA is delivered to the cathode, positioned bilaterally in the cranial region corresponding to the supplementary motor cortex, with the anode positioned in the deltoid (neutral region), in 30-minute sessions, 5 days a week (Mondays through Fridays) for four consecutive weeks.
16019253|NCT02743715|Device|Sham tDCS|The cathode is positioned bilaterally in the cranial region corresponding to the supplementary motor cortex, with the anode positioned in the deltoid (neutral region), in a 30-minute session, 5 days a week (Mondays through Fridays) for four consecutive weeks, without delivery of the electric current.
16019254|NCT02743702|Other|RESPIRATORY PHYSIOTHERAPY|"The protocol designed was composed of the following exercises:
~supine position: inhalation and exhalation with abdominal and thoracic pressures. 5 times
~lateral decubitus, with incentive spirometer lung inflation are made on right/left sides. 3 sets on each side
~sitting position, with the body leaning slightly forward, head and shoulders bent inwardly directed. It inspire called for 3 times, sent off in air through the mouth, after that the child was coughing
~diaphragmatic breathing in a sitting position: after a slow exhalation requested, child should steam a mirror with his mouth slightly open. 3 replications
~in a sitting position, with help of an ambu bag, we made inflations. Repeated 3 times
~exercises of upper member coupled to respiratory rhythm: shoulder flexion and extension was carried out during the inspiratory phase and the extension and adduction of them during expiration. 3 times"
16019255|NCT02743702|Other|USUAL THERAPIES|
16019256|NCT02743663|Procedure|Bronchodilator response|Bronchodilator (Salbutamol - dose dependent on participant prescription) to wheezing subjects. 15 minutes after bronchodilator, spirometry and FOT repeated.
16019257|NCT02743663|Procedure|Allergy Skin Test|Child will be tested for allergies to 17 different allergens, and positive (histamine) and negative (glycerin) controls, for a total of 19 allergens.
16019258|NCT02743663|Procedure|Multiple-Breath Washout|Facemask in children 3-5 yrs, Wash-in phase: medical air inhaled during tidal breathing until steady state. Bias flow switched to 100% oxygen. Wash-out phase: patient breathes in 100% oxygen until nitrogen levels reach ~2%. Each test in duplicate and average is calculated.
16019259|NCT02743663|Procedure|Forced Oscillation Technique|Sterile mouthpiece attached to FOT device. Patient is tested seated with noseclips and mouthpiece. FOT device produces oscillations at different frequencies (from that flow into lungs. Device measures resistance and reactance in lungs.
16019260|NCT02743663|Procedure|Spirometry|Forced exhale manoeuvre completed by participant into flow meter, measuring forced exhale volumes and speed.
16019261|NCT02743663|Drug|salbutamol|Given during bronchodilator response.
16019262|NCT02743663|Procedure|Nasal Brush|Nasal brush of 1 inferior turbinate to collect epithelial cells. Collected on either nare, choice dependent on how clear the nare is (i.e. no mucous, no nasal mucosal edema, no major structural impediments).
16019263|NCT02743663|Procedure|Blood sample|8mLs of venous blood collected using a butterfly needle of appropriate gauge. Blood sample used to collect CBC values, total IgE, serum, DNA, plasma, and whole blood.
16019264|NCT02743663|Procedure|Basophil activation test|Collect basophils from whole blood sample, and expose cells to food allergens in flow cytometry machine to measure allergic response, if any.
16019265|NCT02743663|Procedure|Nasal swab|Gentle swabbing of both nasal openings to collect mucous sample for analysis of microbial contents (i.e. bacteria, virus, fungi).
16019266|NCT02743650|Dietary Supplement|Sodium bicarbonate|The initial dose of sodium bicarbonate is 0.3 mEq/kg/d. If a subject meets the protocol criteria, the dose will be increased to 0.6 mEq/kg/d.
16019267|NCT02743637|Drug|SDX-7320|SDX-7320 is a synthetic copolymer-drug conjugate of a novel MetAP2 inhibitor.
16019268|NCT02743624|Procedure|Variation of the level of pressure support during the mechanical ventilation|The pressure support of the patient was changed form the baseline to 20 cmH20 and then stepwise decreased to 2 cmH20,
16019269|NCT02743611|Biological|BPX-701|autologous T cells genetically modified to express the αβ TCR reacting with PRAME peptide/HLA-A2.01 (PRAME TCR) and an inducible safety switch
16019270|NCT02743611|Drug|Rimiducid|dimerizer infusion to activate the safety switch and induce apoptosis of the BPX-701 T cells in the event of toxicity
16019271|NCT02743598|Drug|Liraglutide|
16019272|NCT02743585|Device|Filmarray Blood Culture ID (BCID) panel|The BCID panel is an FDA-approved nucleic acid amplification test (based on nested polymerase chain reaction) which detects Gram positive, Gram negative, the major Candida species and antimicrobial resistance markers (mecA for methicillin resistance, van A/B for vancomycin resistance, blaKPC for KPC carbapenemase) directly from positive blood cultures in < 1 - 1.5 hours
16019273|NCT02743585|Device|Rosco Diagnostica ESBL/carbapenemase screen kit|These kits are CE-marked (Approved in the European Union) rapid chromogenic tests for extended-spectrum beta-lactamase / carbapenemase detection from both blood cultures and cultured bacterial colonies.
16019274|NCT02743572|Other|iron sucrose-1|iron sucrose-1 group with PN of iron supplementation of 100μg/kg/d
16019275|NCT02743572|Other|iron sucrose-2|iron sucrose-2 group with PN of iron supplementation of 200μg/kg/d
16019276|NCT02743572|Other|iron sucrose-3|iron sucrose-3 group with PN of iron supplementation of 300μg/kg/d
16019277|NCT02743572|Other|iron sucrose-4|iron sucrose-4 group with PN of iron supplementation of 400μg/kg/d
16019278|NCT02743559|Device|Mechanical Stimulation using whole body vibration|All participants will undergo whole body vibration (WBV) by standing on the LivMD WBV platform on 5 consecutive mornings
16019279|NCT02743546|Drug|Duvortuxizumab|Duvortuxizumab will be administered at starting dose of 15 nanogram per kilogram (ng/kg) as an intravenous (IV) infusion during Part 1 (Dose Optimization) and at RP2D level determined in Part 1 during Part 2 (Dose Expansion). Participants will receive duvortuxizumab either with or without a priming dose. Participants who receive a priming dose will have infusions on Days 1, 8, and 22 of an initial 35-day cycle and then on Days 1 and 15 of 28-day cycles thereafter. Participants who do not receive a priming dose will have infusions on Days 1 and 15 of 28-day cycles.
16019280|NCT02743546|Drug|Ibrutinib|Ibrutinib will be administered at 560 milligram per day (mg/day) orally once daily during Part 1 (Dose Optimization) and at a dose of 420 mg/day (for participants with CLL) or 560 mg/day (for participants with DLBCL, FL, or MCL) during Part 2 (Dose Expansion). In Part 1, ibrutinib will be initiated on Day 1 of the initial treatment cycle. In Part 2, ibrutinib will be initiated on Day -7 prior to the initial treatment cycle.
16019281|NCT02743520|Device|The Lifestar Act III|The Lifestar Act III is a chest-worn continuous Electrocardiogram (ECG) monitor and arrhythmia detector. The device is equipped with four electrodes on a harness with a Bluetooth transceiver and a buzzer. The ECG signals will be transmitted via Bluetooth to an application arranged to process and transmit the ECG recordings.
16019282|NCT02743494|Drug|Nivolumab|Specified dose on specified days
16019283|NCT02743494|Other|Placebo|Specified dose on specified days
16019284|NCT02743455|Drug|ISA-720|The vaccine adjuvant ISA 720 will be used with Modified Vaccinia Ankara-Bavarian Nordic-Yellow Fever (MVA-BN-YF) as vaccine adjuvant with a depot effect. This comprises slow release of antigen at the injection site, protection of antigen against degradation and strong stimulation of the immune response.
16019285|NCT02743455|Biological|MVA Smallpox Vaccine|Modified Vaccinia Ankara-Bavarian Nordic Smallpox Vaccine (MVA BN(R)) is a purified live vaccine will be used as an active comparator.
16019286|NCT02743455|Biological|MVA-BN Yellow Fever Vaccine|Modified Vaccinia Ankara-Bavarian Nordic-Yellow Fever (MVA-BN-YF) clinical trial material is manufactured in CEF cells derived from Specific Pathogen Free (SPF) eggs in a bioreactor culture using serum free medium.
16019287|NCT02743455|Other|Placebo|0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection.
16019288|NCT02743455|Other|Placebo|0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection.
16019289|NCT02743455|Biological|YF Vax 17D Strain|Yellow Fever Vaccine (YF-VAX) is a vaccine prepared by culturing the 17D-204 strain of yellow fever virus in living avian leucosis virus-free (ALV-free) chicken embryos. Will be used as an active comparator.
16019290|NCT02743442|Device|da Vinci® Si™|
16019291|NCT02743429|Drug|dinutuximab beta|"Up to 5 cycles of continuous infusion of ch14.18/CHO is administered at a dose of 10 mg/m2/day over 10 days (total dose 100 mg/m2/cycle).
~Cycle duration: 35-days."
16019292|NCT02743416|Other|ECG screening (Zenicor-ECG) for atrial fibrillation|Determination of the biomarker NT-proBNP together with single-lead ECG screening for silent atrial fibrillation.
16019293|NCT02743403|Device|Neurodyn Portable activeTENS, IBRAMED®|Randomization and secret Allocation active TENS (GI / n = 27)
16019294|NCT02743403|Device|Neurodyn Portable placeboTENS, IBRAMED®|Randomization and secret Allocation placebo TENS (GII / n = 27)
16019295|NCT02743403|Device|Carboxyderm S20-1C|Randomization and secret Allocation control group (CG / n = 27).
16019296|NCT02743390|Biological|Infliximab|Monoclonal antibody biologic drug that inhibits tumour necrosis factor alpha (TNF-α), 3 mg/kg for 2 hours (250mL)
16019297|NCT02743390|Other|Saline|Saline for 2 hours (250mL)
16019298|NCT02743377|Other|Brain PET Imaging with 11C Rolipram|Brain PET Imaging, single scan, with 11C Rolipram 20 mCi given intravenously at the start of the scan
16019299|NCT02743377|Drug|Whole Body PET Baseline with 11C Rolipram|Whole Body Baseline PET Imaging, single scan, with 11C Rolipram 20 mCi given intravenously at the start of the scan
16019300|NCT02743377|Drug|Whole Body PET Blocked with Roflumilast|Whole Body PET Imaging scan after blockade with Roflumilast 500 mcg PO, given 1-2 hours prior to start of scan
16019301|NCT02743364|Other|Laboratory Biomarker Analysis|Correlative studies
16019302|NCT02743364|Other|Placebo Administration|Given PO
16019303|NCT02743364|Other|Quality-of-Life Assessment|Ancillary studies
16019304|NCT02743364|Other|Questionnaire Administration|Ancillary studies
16019305|NCT02743364|Drug|Simvastatin|Given PO
16019306|NCT02743351|Biological|ProTmune|Ex-vivo, programmed mobilized peripheral blood (mPB) cells
16019307|NCT02743351|Biological|Control Arm|Untreated mobilized peripheral blood (mPB) cells
16019308|NCT02743338|Behavioral|Sleep Restriction|Behavioral component of CBT-i. Sleep restrictions includes curtailing bed time to match sleep time as registered during the first week of treatment, and expanding bed time contingent upon increased sleep efficiency, until optimal balance between sleep time and sleep efficiency is reached. The first five weeks, therapist support is provided via written messages. The next five weeks, patient works independently. At the end of tenth treatment week, therapist and patient make plan for future.
16019309|NCT02743338|Behavioral|Sleep Compression|Behavioral component of CBT-i. Sleep compression includes gradually compressing bed time over several weeks to approach sleep time as registered during the first week of treatment, and stopping compression when optimal balance between sleep time and sleep efficiency is reached. The first five weeks, therapist support is provided via written messages. The next five weeks, patient works independently. At the end of tenth treatment week, therapist and patient make plan for future.
16019310|NCT02743338|Behavioral|Additional CBT-i components|After 5+5 weeks of either Sleep Restriction or Sleep Compression, a randomized sample from each treatment Group is offered additional components of CBT-i, such as Stimulus Control, Cognitive Restructuring, Relaxation and Visualization for 10 weeks, without therapist support. Component allocation based on individual analysis.
16019311|NCT02743325|Procedure|SVT ablation by ALARA protocol|Catheter ablation is a procedure that uses radiofrequency energy (similar to microwave heat) to destroy a small area of heart tissue that is causing arrhythmias. Destroying this tissue helps restore your heart's regular rhythm. The usage of CartoUnivuTM allows a seamless combination of a fluoro image and Carto® 3 System maps into a single view.
16019843|NCT02739555|Drug|Acide Zoledronique|
16019312|NCT02743325|Procedure|SVT ablation by conventional protocol|Catheter ablation is a procedure that uses radiofrequency energy (similar to microwave heat) to destroy a small area of heart tissue that is causing arrhythmias. Destroying this tissue helps restore your heart's regular rhythm. The convention Ablation procedure works without a 3D navigation System.
16019313|NCT02743312|Device|Torso Weights|Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss.
16019314|NCT02743312|Device|Sham Weights|Following assessment of an individual's directional instability, small weights are applied to a vest-like garment to correct balance loss. The garment is then taken by another investigator and the actual weights are replaced with sham weights.
16019315|NCT02743312|Device|Fitbit Flex|Potential effect on participants' physical activity to see their own step count using this wrist-worn remote monitoring device.
16019316|NCT02743299|Device|Handivent Ventilator|CPR with use of a turbine-driven ventilator (Handivent)
16019317|NCT02743286|Behavioral|Frequent sit-to-stands|Participants will visit the clinic for a 6-hour monitoring period. Following a 1-hour sitting run-in period, participants will sit for an additional 5-hour period including 15 2-minute standing interruptions, 3 per hour. Baseline, mid-point, and end-of-visit bathroom breaks for urine sample collection will be conducted, with additional bathroom breaks allowed as needed.
16019318|NCT02743286|Behavioral|Walking breaks|Participants will visit the clinic for a 6-hour monitoring period. Following a 1-hour sitting run-in period, participants will sit for an additional 5-hour period including 5 2-minute walking interruptions, 3 per hour. Baseline, mid-point, and end-of-visit bathroom breaks for urine sample collection will be conducted, with additional bathroom breaks allowed as needed.
16019319|NCT02743286|Behavioral|Stand more|Participants will visit the clinic for a 6-hour monitoring period. Following a 1-hour sitting run-in period, participants will sit for an additional 5-hour period including 5 10-minute standing interruptions, 1 per hour. Baseline, mid-point, and end-of-visit bathroom breaks for urine sample collection will be conducted, with additional bathroom breaks allowed as needed.
16019320|NCT02743260|Drug|pitavastatin|
16019321|NCT02743260|Drug|Metformin|
16019322|NCT02743260|Drug|digoxin|
16019323|NCT02743260|Drug|Adefovir|
16019324|NCT02743260|Drug|sitagliptin|
16019325|NCT02743247|Drug|Tacrolimus|
16019326|NCT02743247|Drug|Mycophenolate mofetil|
16019327|NCT02743234|Other|Fecal microbiota transplantation|FMT follows 4-10 days of vancomycin 125 mg x 4 daily
16019328|NCT02743234|Drug|Fidaxomicin|Fidaxomicin 200 mg x 2 daily for 10 days
16019329|NCT02743234|Drug|Vancomycin|Vancomycin 125 mg x 4 daily for 10 days
16019330|NCT02743221|Drug|Trifluridine/tipiracil + bevacizumab|Patients were treated withTrifluridine/tipiracil + bevacizumab regimen until they met a discontinuation criterion.
16019331|NCT02743221|Drug|Capecitabine + bevacizumab|Patients were treated with capecitabine+ bevacizumab regimen until they met a discontinuation criterion.
16019332|NCT02743208|Device|Short stem hip arthroplasty (SHA)|Furlong Evolution femoral stem
16019333|NCT02743208|Device|Total hip arthroplasty (THA)|Furlong H-A.C. femoral stem
16019334|NCT02743195|Dietary Supplement|Polyphenol/prebiotic blend|
16019335|NCT02743182|Drug|Pegylated interferon alfa-2a|
16019336|NCT02743169|Other|Spatially-Optimized|Spatial analysis of retrospective data will be used to optimize the placement of ambulances to decrease response time from the time the call is received until the time the ambulance arrives at the patient's location.
16019337|NCT02743156|Procedure|IVUS-guided PCI|intravascular ultrasound-guided percutaneous coronary intervention
16019338|NCT02743156|Procedure|Angiography-guided PCI|Angiography-guided percutaneous coronary intervention. This is the conventional treatment.
16019339|NCT02743143|Behavioral|Exercise therapy|
16019340|NCT02743143|Other|Follow-up care as usual|
16019341|NCT02743130|Dietary Supplement|Blackcurrant Nectar|Consumption of a single dose (300 ml)
16019342|NCT02743130|Dietary Supplement|Lingonberry Nectar|Consumption of a single dose (300 ml)
16019343|NCT02743130|Dietary Supplement|Reference|Consumption of a single dose (300 ml)
16019344|NCT02743117|Biological|Monovalent Influenza Vaccine|A single dose of 10^(7.0 ± 0.5) FFU strain of monovalent influenza vaccine will be administered as intranasal spray on Day 1.
16019345|NCT02743117|Other|Placebo|A single dose of placebo matched to monovalent influenza vaccine will be administered as intranasal spray on Day 1.
16019346|NCT02743104|Drug|Ketamine|
16019347|NCT02743104|Drug|Propofol|
16019348|NCT02743104|Drug|midazolam and atropine|
16019349|NCT02743104|Drug|Lidocaine|
16019350|NCT02743078|Drug|Bevacizumab|10 mg/kg every 2 weeks intravenously over 30 minutes.
16019351|NCT02743078|Device|TTFields Therapy|Device is worn continuously at least 18 hours a day on average, with 1-3 days off every four weeks.
16019352|NCT02743065|Device|HepaSphere with 50-75mg Doxorubicin|HepaSphere with 50-75mg Doxorubicin
16019353|NCT02743052|Drug|Anticoagulation treatment.|Details of anticoagulation treatment information will be gathered including low molecular-weight heparin (enoxaparin 1 mg/kg) vs. NOAC (rivaroxaban 15 or 20 mg), vs. warfarin (target INR2.0-3.0) or no use of anticoagulation per physicians' decision and patients' conditions.
16019354|NCT02743039|Behavioral|CareerAdvance®|CareerAdvance® is a dual-generation program providing education, career coaching, and soft-skills training for parents while their children attend CAP Tulsa's Head Start programs.
16019355|NCT02743026|Behavioral|FOXY|This study will evaluate an arts-based HIV prevention program, Fostering Open eXpression among Youth (FOXY) in the NWT, Canada that works with Northern and Indigenous youth to promote sexual health and reduce exposure to HIV/STI. FOXY explores sexual health, HIV/STIs, sexuality and healthy relationships with young women in the NWT. The program's goal is to use arts-based methods and peers to facilitate education and foster more open expression and communication regarding sexual health and sexuality. FOXY uses arts-based approaches in program delivery; for example, drama techniques are used to facilitate discussion and learning about healthy relationships and making positive choices in realistic sexual scenarios.
16019356|NCT02743013|Drug|CHF 5993 100/6/12,5 pMDI|
16019357|NCT02743013|Drug|CHF 5993 100/6/12,5 DPI Test 1|
16019358|NCT02743013|Drug|CHF 5993 100/6/12,5 DPI Test 2|
16019359|NCT02743013|Drug|CHF 5993 100/6/12,5 pMDI replicate|
16019363|NCT02742987|Drug|Standard medical therapy|Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions
16019364|NCT02742974|Device|FloTrac™ and EV1000™|Interventions to improve cardiovascular performance will be made in all patients whose cardiovascular function is sub-optimal in accordance with routine clinical management during trauma resuscitation. Patients who meet inclusion criteria will be assigned to the intervention or control arm of the study based on the process outlined in the protocol. Patients assigned to the intervention arm will have intra-operative hemodynamic monitoring performed by the anesthesia staff and cardiovascular interventions will be based off of the algorithm described in the protocol. Members of anesthesia or the surgical team can initiate interventions as indicated during routine ICU care or intra-operatively.
16019365|NCT02742961|Other|Peripheral nerve block|A physician billing code for deposition of a local anesthetic solution around an anatomically defined nerve or nerve plexus
16019366|NCT02742948|Drug|ceftriaxone|IV ceftriaxone (2g) will be given to all participants
16019367|NCT02742935|Biological|SHR-1210|A fully human monoclonal immunoglobulin (IgG4 subtype)
16019368|NCT02742922|Behavioral|Culturally adapted therapy (C-MAP)|C-MAP is a brief problem focused therapy, comprising of six sessions delivered within three months. C-MAP is a manual assisted intervention based on the principles of CBT .In this intervention there is an evaluation of the self-harm attempt, crisis skills, problem solving and basic cognitive techniques to manage emotions, negative thinking and relapse prevention strategies.
16019369|NCT02742909|Drug|rhBNP|rhBNP was administered as a continuous infusion for 24 hours before or after placebo
16019370|NCT02742909|Drug|placebo|normal saline as a placebo was administered as a continuous infusion for 24 hours
16019371|NCT02742896|Other|Erectile dysfunction|"The changes of erectile function by using official questionnaire-The International Index of Erectile Function (IIEF)-5 1 year after conversion to sinus rhythm.
~The changes of cognitive function by using validated assessment form-The Montreal Cognitive assessment (MoCA) 1 year after conversion to sinus rhythm."
16019372|NCT02742883|Drug|Antineoplaston therapy (Atengenal + Astugenal)|Patients with diffuse intrinsic pontine glioma will receive Antineoplaston therapy (Atengenal + Astugenal).
16019373|NCT02742870|Other|Correlation of MRI results with clinical characteristics of the adnexal mass|"Quantitative analysis of the magnetic resonance images realised with the Ingenia 3 Tesla Engine (Philips) and the Area 1,5 Tesla Engine (Siemens), based on the ADC cartography.The post-processing will be realized with the Syngo Onco Care application of Siemens, that allows an histogram analysis of the ADC of all sections of the adnexal mass, as opposed to a section per section approach with the Region of Interest (ROI) method.
~The results will be correlated with the clinical data regarding the adnexal mass: anatomo-pathology status (malignancy and aggressiveness of the tumor) and the gynecological follow-up."
16019374|NCT02742857|Biological|BQ-A Peptide Extract|BQ-A Peptide Extract
16019375|NCT02742857|Biological|Mesenchymal Stem Cells|Mesenchymal Stem Cells
16019376|NCT02742857|Device|Transcranial Laser Therapy|Transcranial Laser Therapy
16019377|NCT02742857|Device|Median Nerve Stimulator|Median Nerve Stimulator
16019378|NCT02742844|Biological|APZ2 application|Application of IMP on patients wound.
16019379|NCT02742831|Behavioral|Intervention|"The intervention group will receive a 6-session intervention. The overview of the 6 sessions is as follows:
~Behavioral chain analysis of episode where parent felt stressed with child and episode where things went well. Identification of sources of interpersonal support.
~Stress relief techniques. Identification of short and long-term goals. Development of a detailed crisis plan.
~Problem solving techniques.
~Emotional regulation. Exercises to identify moods and explore connections between feelings, thoughts, and behavior.
~Positive parenting, review of common and specific parenting challenges, child development, short and long-term effects of different discipline approaches.
~Reflection, repeat behavioral chain analysis. Update crisis plan."
16019380|NCT02742831|Other|Control|The families in the control group will be contacted by a member of the study team 6 times in 12 weeks to approximate the frequency of contact that the intervention group receives. The study team member will check in with families on the telephone or in person and will help them connect with clinic and community resources as needed.
16019381|NCT02742818|Device|Upper body blanket, Bair Hugger|Upper body warming blanket will be used in patients undergoing LEA and EVAR.
16019382|NCT02742818|Device|Underbody blanket, Bair Hugger|Underbody warming blanket will be used in patients undergoing LEA and EVAR.
16019383|NCT02742805|Dietary Supplement|Vitamin D (4,000 IU/day)|High Dose of 4,000 IU/day.
16019384|NCT02742805|Dietary Supplement|Vitamin D (400 IU/day)|Low Dose of 400 IU/day.
16019385|NCT02742805|Drug|Omalizumab|Standard of care dose.
16019386|NCT02742792|Other|Resistance training|Twenty-four strength training sessions consisted in exercises of extension and flexion knees, lat pull-down, elbow extension and flexion, sitting bench press and hip abduction.
16019387|NCT02742792|Other|Advice on Lifestyle|Patients receive advice on lifestyle. Patients will be asked to participate in the elderly group meetings the basic health unit linked to the hospital.
16019388|NCT02742779|Drug|GDC-0310|Participants will receive single or multiple ascending doses of GDC-0310 orally in fasted or fed state.
16019389|NCT02742779|Drug|Placebo|Participants will receive placebo matched to GDC-0310 as single or multiple oral dose in fasted or fed state.
16019390|NCT02742766|Drug|GSK3008356|This intervention is available as 0.5, 1, 5, and 25 mg white oral tablet. The formulation will be used to administer dose of 5 mg, 10 mg, 30 mg, 45 mg, 75 mg, 90 mg, 125 mg, 180 mg, 200 mg, and 250 mg total daily dose during the study.
16019391|NCT02742766|Drug|Placebo|This intervention is available as white oral tablet. The formulation will be used as a matching placebo for GSK3008356 during the study.
16019392|NCT02742753|Other|Data collection|Data will be collected retrospectively linking regional patient-level data prospectively captured in real-world clinical setting with mandatory national healthcare registries from 2004 to 2013.
16019393|NCT02742740|Behavioral|Chemo Buddy|The Study Buddy ECA acts as an advisor to patients on chemotherapy regimens, promoting protocol adherence and retention, providing anticipatory guidance and answering questions, serving as a conduit to capture information about complaints or adverse events, providing a venue for communicating about updates.
16019441|NCT02742428|Procedure|Acute paracentesis.|Evacuation of a large (>5000ml) volume of ascites via single abdominocentesis. Allowed in observational arm only, in case of acute symptoms concerned with ascites.
16019394|NCT02742727|Biological|anti-CD7 CAR-pNK cells|The allogeneic NK cells (NK-92 cell line for clinical use) are engineered to contain anti-CD7 attached to TCRzeta, CD28 and 4-1BB signaling domains. These modified cells are called chimeric antigen receptor NK cells with specificity for CD7.
16019395|NCT02742714|Device|PillCam SBC system|The PillCam SBC system to be tested in this study, is a new system composed of capsule, Data recorder and a new software Pillcam Desktop Software (version 9.0). The main features of the SBC capsule are panoramic field of view and adaptive frame rate customized for complete coverage of both small bowel and colonic mucosa.
16019396|NCT02742701|Other|diagnosis|Measurement of glycosuria
16019397|NCT02742688|Dietary Supplement|Pyrus pyrifolia var. culta(Makino) NaKai peel extract|Pyrus pyrifolia var. culta(Makino) NaKai peel extract(4g/day)
16019398|NCT02742688|Dietary Supplement|Placebo|Placebo(4g/day)
16019399|NCT02742675|Drug|Bicalutamide|Given orally
16019400|NCT02742675|Drug|goserelin acetate|Given subcutaneously or as an injection
16019401|NCT02742675|Drug|flutamide|Given orally
16019402|NCT02742675|Drug|leuprolide acetate|Given subcutaneously or as an injection
16019403|NCT02742675|Drug|triptorelin|Given subcutaneously or as an injection
16019404|NCT02742675|Procedure|Definitive Treatment|surgery to remove prostate or radiation therapy to the prostate.
16019405|NCT02742662|Device|Wearable technology, smartscale|
16019406|NCT02742662|Behavioral|Smartphone applications|
16019407|NCT02742662|Behavioral|Standard Weight Management Visits|
16019408|NCT02742649|Drug|Fixed Combination|Continuous elution from the ocular insert.
16019409|NCT02742649|Drug|Bimatoprost|Continuous elution from the ocular insert. This is an active control arm.
16019410|NCT02742649|Drug|Timolol|Continuous elution from the ocular insert. This is an active control arm.
16019411|NCT02742649|Device|Placebo Segment|One segment of placebo (no drug product)
16019412|NCT02742649|Drug|Timolol 0.5%|0.5% timolol drops twice daily.
16019413|NCT02742636|Device|Foley catheter|The aim of this study is to evaluate if direct removal of the urine catheter after an LH (total laparoscopic hysterectomy and laparoscopic supracervical hysterectomy) is associated with similar (or better) outcomes compared to delayed catheter removal after surgery.
16019414|NCT02742623|Drug|Rivaroxaban (Xarelto, BAY 59-7939)|Treatment with rivaroxaban for DVT and/ or PE and/ or prevention of recurrent DVT and PE according to local label
16019415|NCT02742610|Behavioral|Mindfulness with Contingency Management|
16019416|NCT02742610|Behavioral|Active Control|
16019417|NCT02742597|Behavioral|TIP / IMPACT Plus Care Coordination|The intervention will involve the patient attending an interdisciplinary team meeting, either through the Ontario Telemedicine Network's teleconferencing technology or in person, along with their caregiver(s), the referring practitioner, inter-professional (IP) teams and home care coordinators to discuss and uncover the patient's condition covering a diverse range of medical, functional and psycho-social issues and the development of a patient-centred treatment plan. The care plans are documented, shared, implemented and monitored by an assigned nurse from the program.
16019418|NCT02742584|Procedure|Cough Stress Test|Varying bladder volumes during cough stress test.
16019419|NCT02742571|Other|non applicable|
16019420|NCT02742558|Biological|Cholvax|Incepta vaccine Limited, a leading pharmaceutical company in Bangladesh is now producing the OCV, Cholvax with technological support from International Vaccine Institute (IVI), which meets international Good Manufacturing Practice (GMP) standards and WHO production guidelines. Cholvax has the same formulation as ShancholTM in terms of strains and formulation.
16019421|NCT02742558|Biological|Shanchol|The vaccine is manufactured by Shantha Biotechnics, in Hyderabad, India and is prequalified by the WHO. Shanchol™ is available in a single dose vial.This vaccine is used as two dose regimen.
16019422|NCT02742545|Behavioral|MayoExpertAdvisor|Access to MayoExpertAdvisor (MEA) in the electronic medical record (EMR). MEA will provide patient-specific knowledge and treatment suggestions for patients with hyperlipidemia, atrial fibrillation, and/or heart failure via a clickable tab in the Mayo Clinic EMR.
16019423|NCT02742532|Drug|Oxytocin|Intranasal oxytocin 40 IU
16019424|NCT02742532|Drug|Placebo|Intranasal saline solution
16019425|NCT02742519|Drug|ivacaftor|
16019426|NCT02742519|Drug|Placebo|
16019427|NCT02742506|Other|Electroencephalography (EEG)|EEG will be performed to assess brain activity in response to sounds of different nature, including music and the given name of the registered person
16019428|NCT02742493|Other|0.028 bonded to canines|lower fixed canine and canine retainer (0.028 stainless steel bonded to canines) and upper removable Hawley (Intervention A)
16019429|NCT02742493|Other|0.027 7-strand bonded to all 6|lower fixed canine to canine retainer (7-strand Twistflex 0.027 bonded to all six anterior teeth) and upper removable Hawley (Intervention B)
16019430|NCT02742493|Other|removable Hawley-type|lower Hawley-type and upper Hawley removable retainer (Control)
16019431|NCT02742480|Drug|Dabigatran|
16019432|NCT02742480|Drug|Acenocoumarol|
16019433|NCT02742467|Drug|Perindopril plus Amlodipine|Group 1
16019434|NCT02742467|Drug|Perindopril plus Hydrochlorothiazide|Group 2
16019435|NCT02742467|Drug|Amlodipine plus Hydrochlorothiazide|Group 3
16019436|NCT02742454|Procedure|Standard 30-60 Seconds Cord Clamping|The infant will be stimulated to breathe after birth. If the infant is not breathing well, the cord will be clamped at 30 seconds. If the baby is breathing well, the cord will be clamped at 60 seconds. Ventilatory assistance will be given after cord clamping.
16019437|NCT02742454|Procedure|VentFirst 120 Seconds Cord Clamping|The infant will be stimulated to breathe after birth. If the infant is not breathing well, Positive Pressure Ventilation by face mask will be given starting at 30 seconds. If the baby is breathing well, Continuous Positive Airway Pressure (CPAP by face mask) will be given starting at 30 seconds. The cord will be clamped at 120 seconds.
16019438|NCT02742441|Drug|122-0551 Foam|Topical Foam containing active drug
16019439|NCT02742441|Drug|Vehicle Foam|Topical Foam containing no active drug
16019440|NCT02742428|Device|Systematic ascites evacuation|Systematic ascites evacuation via indwelling catheter inserted into abdominal cavity, sutured to the skin. Drainage performed by the patient, on demand with day limit of 2000ml, in ambulatory settings.
16019522|NCT02741791|Drug|Bupropion|Buproprion taken daily for 6 weeks.
16019442|NCT02742428|Behavioral|Interview.|Interview according to provided chart in order to collect data concerning symptoms, co-morbidities.
16019443|NCT02742428|Behavioral|Quality of life.|Patients will be asked to fill in a quality of life questionnaire (EORTC-C15-PAL) before randomization and 7 days later.
16019444|NCT02742428|Behavioral|Nutritional status.|Patients will be asked to fill in (together with a physician) a questionnaire to assess risk of malnutrition (SGA) before randomization and 7 days later.
16019445|NCT02742415|Behavioral|Caring Hand Massage|Caring Hand Massage is a hand massage therapy program with several steps and techniques.
16019446|NCT02742402|Other|Diagnostic imaging|Abdominal ultrasound, followed by abdominal computed tomography when necessary
16019447|NCT02742402|Other|Observation|Observation for 6 to 8 hours. After observation period repeated clinical examination and repeated blood test for calculation of Adult Appendicitis Score is done.
16019448|NCT02742389|Other|Preprocedure Telephone Call|The participants will receive a phone call from the investigators 1 week before their testing to talk about the procedure and answer any questions that patients may have . The investigator calling the participant will document the duration of the phone call and any questions asked by the participant
16019449|NCT02742376|Other|Soft surface|A sponge rectangle used in physiotherapy will be placed on the floor,
16019450|NCT02742376|Other|Floor|A marked path on the floor where the subject is instructed to walk.
16019451|NCT02742376|Other|Kyboot shoes|Special shoes will be worn by the subject.
16019452|NCT02742363|Other|Collecting data|
16019453|NCT02742350|Device|IMT - POWERbreathe Plus Light Resistance®, SP, BR|POWERbreathe Plus Light Resistance®, SP, BR
16019454|NCT02742324|Drug|Ruxolotinib|Ruxolitinib is administered orally twice a day (bid) everyday in 28-day treatment cycles. The starting dose is 10 mg BID and may go up to 20 mg BID. Ruxolotinib therapy starts on Cycle 1 day 1.
16019455|NCT02742324|Drug|peg-IFN alpha -2a|Peg-IFN-alpha-2a is administered subcutaneously once a week. The doses tested are 45, 90 and 135 mcg/week. .Peg-IFN-alpha-2a therapy starts at Cycle 1Day 15.Of note, Peg-IFN-alpha-2a will only be started if the platelet count is ≥ 50x109/L at C1D15.
16019456|NCT02742311|Procedure|Endoscopic disectomy|Endoscopic discectomy is an established method for treatment of lumbar disc herniation. Edoscopic discectomy provides a safe and minimal access corridor for lumbar discectomy. The technique also allows early postoperative mobilization and faster return to work.
16019457|NCT02742298|Device|Muscle ultrasound|Ultrasound images of limb muscles will be collected.
16019458|NCT02742298|Other|Electrical Impedance Myography|A painless current passes through the skin and surface electrodes are used to record the impedance through muscle.
16019459|NCT02742285|Drug|Artemether + lumefantrine|A single adult dose of artemether-lumefantrine will be administered on a unique occasion together with food. Venous and capillary blood samples will be collected at 6 to 10 time points, as defined before drug administration with each volunteer.
16019460|NCT02742259|Device|Blood Draw|Blood draws only - non-diagnostic, non-treatment
16019461|NCT02742246|Behavioral|Individual clinician-provided CBT|Individual clinician-provided CBT
16019462|NCT02742246|Behavioral|CBT4CBT|CBT computer program assisted therapy
16019463|NCT02742233|Drug|saxagliptin|"Qualifying Period: Participants will receive regular treatment for diabetic ulcer without DPP4i.
~Treatment Period: Participants will receive saxagliptin with regular treatment"
16019464|NCT02742233|Drug|placebo|"Qualifying Period: Participants will receive regular treatment for diabetic ulcer without DPP4i.
~Treatment Period: Participants will receive placebo with regular treatment"
16019465|NCT02742220|Other|Isometric Handgrip Training Group|Intervention period will last eight weeks. Experimental group will perform three sessions per week of home-based handgrip exercise. The exercise protocol will consist of four unilateral sets (dominant arm) with two minutes of isometric contraction, with 30% of maximum voluntary contraction, and four minutes of interval between sets. Patients will receive a diary to record the sessions and report difficulties during the training. Visits will be scheduled at weeks 1 and 5 to provide feedback to individuals, discuss possible problems during the training and adjust the intensity of the exercise. In addition the patients be recommended to increase daily physical activity levels, and weekly, there will be phone contacts with the patients to reinforce the exercise recommendations.
16019466|NCT02742220|Other|Control Group|Intervention period will last eight weeks. Patients will be recommended to increase daily physical activity levels, and weekly, there will be phone contacts to reinforce the recommendations.
16019467|NCT02742207|Other|Electrical atrial fibrillation Cardioversion|Electrical cardioversion for patients admitted for Atrial Fibrillation
16019468|NCT02742207|Other|Cardioversion|Electrical cardioversion for patients admitted for Atrial Fibrillation
16019469|NCT02742194|Dietary Supplement|Dry extract of ginger|Restrictive diet plus three capsules of 200 mg of dry extract of ginger (5% active ingredient) to be taken three times a day for six months.
16019470|NCT02742194|Dietary Supplement|Placebo|Restrictive diet plus three capsules of 200 mg of cellulose to be taken three times a day for six months.
16019471|NCT02742181|Drug|Alvimopan|Subjects diagnosed with a post operative ileus after surgery will be given alvimopan
16019472|NCT02742181|Other|Control Group|Standard postoperative care
16019473|NCT02742168|Radiation|99mTc-3PRGD2|"Diagnostic group：For patients in suspicion of breast cancer, single intravenous bolus injection of nearly 0.3 mCi/kg body weight of 99mTc-3PRGD2 on day one of the treatment period, whole-body planar and lesions SPECT/CT to determine the accumulation of 99mTc-3PRGD2 in the tumors and the other parts of the body.
~Efficacy evaluation group：patients firstly diagnose with malignant lesions ,and prepare to chemotherapy(including neoadjuvant chemotherapy) or radiotherapy.the same dose of 99mTc-3PRGD2 will be intravenously injected into the patients before treatment ,the second period,the sixth period( almost three months after the initial treatment)，whole-body planar and lesions SPECT/CT to assess the value of 99mTc-3PRGD2 in evaluation of cancers."
16019474|NCT02742155|Behavioral|Play2Sleep|Behavioral: Video self-modelling
16019475|NCT02742155|Behavioral|Comparison|Behavioral: Information only
16019476|NCT02742142|Other|water as placebo|topical application of water as a placebo in the control arm
16019477|NCT02742142|Drug|silver diammine fluoride|topical application of the SDF solution onto tooth root surfaces
16019523|NCT02741778|Procedure|Minimally invasive group|In this group, all manipulations are finished by laparoscopy and thoracoscopy.
16019478|NCT02742129|Drug|Nebulized Sodium Nitrite|Inhaled, nebulized inorganic sodium nitrite vs. inhaled, nebulized placebo at a dose of 80 mg (or maximally tolerated dose) administered at a minimum of 4 hours apart, three times per day, during the active part of the day.
16019479|NCT02742129|Drug|Placebo|Inhaled, nebulized placebo vs. inhaled, nebulized inorganic sodium nitrite at a dose of 80 mg (or maximally tolerated dose) administered at a minimum of 4 hours apart, three times per day, during the active part of the day.
16019480|NCT02742116|Genetic|DNA screening before Pregnancy|"Saliva/swab shall be collected from couple for Hereditary Disease DNA screening test. Blood sample shall be taken by venipuncture of women for Fragile X carrier screening A pre-test questionnaire will be conducted to assess subject's knowledge, views and preferences in receiving expanded carrier screening, choice of having concurrent or sequential screening, factors affecting their choices, anxiety level, and their willingness to pay for the test.
~A post-test self-administered questionnaire shall be filled in by the patient on receiving the test results.
~Couples who receive a screen positive result shall be subsequently referred to Queen Mary Hospital for joint counselling by clinical geneticist and gynaecologist. This consultation shall be audiotaped or videotaped."
16019481|NCT02742103|Biological|CSL_112|CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.
16019482|NCT02742103|Other|Placebo|0.9% weight/volume sodium chloride solution (ie, normal saline)
16019483|NCT02742090|Drug|TGR-1202|
16019484|NCT02742077|Device|Robotic-assisted peripheral vascular intervention|Remote delivery and manipulation of guidewires and rapid exchange catheters during percutaneous vascular interventions.
16019485|NCT02742064|Other|Cogito Companion Mobile Phone Application|
16019486|NCT02742051|Drug|Everolimus|Neoadjuvant endocrine therapy
16019487|NCT02742051|Drug|Letrozole|Neoadjuvant endocrine therapy
16019488|NCT02742051|Drug|Fluorouracil|Neoadjuvant chemotherapy
16019489|NCT02742051|Drug|Epirubicin|Neoadjuvant chemotherapy
16019490|NCT02742051|Drug|Cyclophosphamide|Neoadjuvant chemotherapy
16019491|NCT02742038|Other|Fluoride varnish plus education|Biannual varnish every 6 month/ 24 months plus educational component
16019492|NCT02742025|Other|Inclusion visit|This visit takes place between days -15 and -7 preceding a coronarography scheduled for Day 0. It is part of standard care and corresponds to a required cardiology consultation.
16019493|NCT02742025|Other|Nurse consultation|This visit takes place on the same day as the inclusion visit and includes practical advice concerning the hospital stay, explanations concerning the surgical act and practical advice on its implementation, information on the length of stay and after. An explanatory booklet concerning the surgical procedure is provided to the patient.
16019494|NCT02742025|Other|Telephone contact|A nurse will telephone the patient 72h to 48h before the coronarography scheduled for day 0. During the telephone conversation the nurse will assess the patient's knowledge about his/her pathology, his/her examination and the course of hospitalization. The nurse will answer any questions and if needed provide further information.
16019495|NCT02742025|Procedure|Coronarography on day 0|This coronarography is scheduled as part of the patient's routine care. This is not an experimental intervention under evaluation.
16019496|NCT02742012|Other|the study is observational|the study is observational
16019497|NCT02741986|Other|Risk estimation|"Physicians will be asked to provide their risk scores (ranging from 0 to 100) for postoperative complications prior to surgery and immediately after the surgery for the same patients that IPS is producing the scores. Physicians will provide scores both before and after reviewing the risk scores produced by the IPS.
~The IPS system will generate risk scores (ranging from 0 to 100) for postoperative complications prior to surgery and immediately after the surgery for patients taken care by the physicians enrolled in the study."
16019498|NCT02741973|Other|Yoga|
16019499|NCT02741973|Other|School sport|
16019500|NCT02741960|Drug|metformin|500 mg metformin three times daily
16019501|NCT02741960|Drug|placebo|500 mg placebo three times daily
16019502|NCT02741947|Drug|Levodopa Benserazide Madopar|Madopar 100+25mg and 200+50mg, tablet, tid e qid, for four weeks
16019503|NCT02741947|Drug|Levodopa Benserazide Teva Italia|Levodopa benserazide Teva 100+25mg and 200+50mg, tablet, tid e qid, for four weeks
16019504|NCT02741921|Device|VivaSight DL|intubation using VivaSight DL tube
16019505|NCT02741921|Device|conventional double-lumen tube|intubation using conventional double-lumen tube
16019506|NCT02741908|Behavioral|Calorie counting diet|
16019507|NCT02741908|Behavioral|Fixed diet plan|
16019508|NCT02741895|Behavioral|Fitbit monitoring|Patients will be fitted with a Fitbit after surgery, which will monitor steps and active minutes for the duration of hospitalization.
16019509|NCT02741882|Other|Questionary|Questionary with clinical, demographic and behavior outcomes at the pregnancy period
16019510|NCT02741869|Device|photodynamic therapy (Ondine: MRSAid™)|Photodisinfection using MRSAid™ for the decolonization of S. aureus in hemodialysis patients
16019511|NCT02741856|Drug|Carboplatin|For more information please see the arm descriptions section.
16019512|NCT02741856|Drug|Paclitaxel|For more information please see the arm descriptions section.
16019513|NCT02741856|Drug|Cisplatin|For more information please see the arm descriptions section.
16019514|NCT02741856|Drug|Capecitabine|For more information please see the arm descriptions section.
16019515|NCT02741856|Radiation|Radiotherapy|For more information please see the arm descriptions section.
16019516|NCT02741843|Behavioral|Patient Education|
16019517|NCT02741817|Drug|Aspirin|The intervention has been described previously in both arms individually. Group A will receive 20mg of soluble Aspirin and group B with 75mg of soluble Aspirin. As this is a crossover study, all patients will fall under both groups throughout the duration and be un-blinded.
16019518|NCT02741804|Dietary Supplement|BBH-1001 Brain Health Supplement|Treatment with supplement consisting of turmeric, fish oil, vitamin D and green tea extract OR placebo.
16019519|NCT02741804|Other|Lifestyle Intervention|All patients will be given lessons on 6 areas of lifestyle: nutrition, physical activity, meditation, sleep hygiene, cognitive activity, and social activity.
16019520|NCT02741804|Dietary Supplement|Brain Health Placebo|Treatment with placebo consisting of soybean oil
16019521|NCT02741791|Drug|AXS-05|AXS-05 taken daily for 6 weeks.
16019530|NCT02741726|Device|acupoint stimulation|Electric stimulation was given through electrode attached to acupoints
16019531|NCT02741726|Device|no stimulation|patients were only attached electrodes without electric current
16019532|NCT02741713|Procedure|"PECS Pectoralis 1 and 2 Blocks"|"An interscalene and a PECS Pectoralis 1 and 2 block will be performed on the subjects."
16019533|NCT02741713|Procedure|Interscalene Block|An interscalene block will be performed on the subjects.
16019534|NCT02741713|Procedure|Sham Block|
16019535|NCT02741713|Drug|Solution for Injection in Interscalene Block|20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine
16019536|NCT02741713|Drug|Solution for Injection in Sham Block|Lidocaine 1%
16019537|NCT02741713|Drug|Solution for Injection PECS Blocks|10mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at the PECS1 location and 20mL of 0.25% bupivacaine with 1:400,000 epinephrine and 1:600,000 clonidine dosed at the PECS2 location
16019538|NCT02741700|Behavioral|Improvement of Medication Adherence|The investigators have developed a storytelling intervention for African-Americans with gout, to address barriers to optimal gout management and provide cues for better disease management. The objective of this study is to assess the efficacy of a novel storytelling intervention in Veteran's own voices to improve medication adherence and patient outcomes in African-American Veterans with gout.
16019539|NCT02741687|Drug|Sitagliptin|Participants will take 100 mg/day for patients with glomerular filtration rate (GFR) > 50 and 50 mg/day for GFR 30 - 49, beginning on the day prior to surgery and continuing through hospitalization, up to 10 days.
16019540|NCT02741687|Drug|Placebo|Participants will take one pill daily beginning on the day prior to surgery and continuing through hospitalization, up to 10 days.
16019541|NCT02741687|Drug|Supplemental insulin (insulin lispro)|"Supplemental insulin lispro will be administered before meals, in addition to scheduled insulin dose, following the supplemental insulin scale protocol. At bedtime, half of supplemental sliding scale insulin starting at blood glucose (BG) >240 mg/dL will be given. If a patient is unable to eat, supplemental insulin will be administered every 6 hours with the lowest number of units for that appropriate BG level.
~For subjects receiving supplemental insulin lispro with BG levels greater than 180 mg/dL, the supplemental insulin scale is as follows:
~BG between 181-220 mg/dL; 2-4 units of insulin lispro
~BG between 221-260 mg/dL; 3-5 units of insulin lispro
~BG between 261-300 mg/dL; 4-6 units of insulin lispro
~BG between 301-350 mg/dL; 5-7 units of insulin lispro
~BG between 351-400 mg/dL; 6-8 units of insulin lispro
~BG > 400 mg/dL; 7-9 units of insulin lispro"
16019542|NCT02741687|Drug|Supplemental insulin (insulin aspart)|"Supplemental insulin aspart will be administered before meals, in addition to scheduled insulin dose, following the supplemental insulin scale protocol. At bedtime, half of supplemental sliding scale insulin starting at blood glucose (BG) >240 mg/dL will be given. If a patient is unable to eat, supplemental insulin will be administered every 6 hours with the lowest number of units for that appropriate BG level.
~For subjects receiving supplemental insulin aspart with BG levels greater than 180 mg/dL, the supplemental insulin scale is as follows:
~BG between 181-220 mg/dL; 2-4 units of insulin lispro
~BG between 221-260 mg/dL; 3-5 units of insulin lispro
~BG between 261-300 mg/dL; 4-6 units of insulin lispro
~BG between 301-350 mg/dL; 5-7 units of insulin lispro
~BG between 351-400 mg/dL; 6-8 units of insulin lispro
~BG > 400 mg/dL; 7-9 units of insulin lispro"
16019543|NCT02741687|Drug|Long acting basal insulin (insulin detemir)|"Long acting basal insulin therapy will be provided as needed, and will be given once daily, at the same time of day. Participants with blood glucose (BG) >180 mg/dL= start detemir at 0.2 units per kg weight per day and will follow the following adjustment schedule:
~Fasting and pre-meal BG between 100-180 mg/dl without hypoglycemia the previous day: no change
~Fasting and pre-meal BG between >180-240 mg/dl: increase detemir or glargine dose by 10% every day
~Fasting and pre-meal BG >241 mg/dl: increase detemir or glargine dose by 20% every day
~Fasting and pre-meal BG <100 mg/dl: reduce detemir or glargine by 20% or stop if patient is already on less than 0.1 units/kg of body weight"
16019544|NCT02741687|Drug|Long acting basal insulin (insulin glargine)|"Long acting basal insulin therapy will be provided as needed, and will be given once daily, at the same time of day. Participants with blood glucose (BG) >180 mg/dL= start detemir at 0.2 units per kg weight per day and will follow the following adjustment schedule:
~Fasting and pre-meal BG between 100-180 mg/dl without hypoglycemia the previous day: no change
~Fasting and pre-meal BG between >180-240 mg/dl: increase detemir or glargine dose by 10% every day
~Fasting and pre-meal BG >241 mg/dl: increase detemir or glargine dose by 20% every day
~Fasting and pre-meal BG <100 mg/dl: reduce detemir or glargine by 20% or stop if patient is already on less than 0.1 units/kg of body weight"
16019545|NCT02741674|Procedure|Roux-en-y gastric bypass (RYGB) - historical|Participant has had RYGB, as identified using existing data
16019546|NCT02741674|Procedure|Adjustable gastric banding (AGB) - historical|Participant has had AGB, as identified using existing data
16019547|NCT02741674|Procedure|Sleeve gastrectomy (SG) - historical|Participant has had SG, as identified using existing data
16019548|NCT02741661|Other|No intervention. Observational study|No intervention
16019549|NCT02741648|Device|Near Infrared Spectroscopy|INVOS 5100C Cerebral/Somatic Oximeter is an FDA-approved device used to measure renal and mesenteric tissue oxygenation, as defined by regional oxygenation saturation levels (rSO2). Two probe site monitoring will be used to evaluate differential tissue bed oxygenation. Adhesive sensor probes are applied to the periumbilical area for mesenteric monitoring and to the flank area for renal monitoring.
16019550|NCT02741635|Device|New Nasal Pillows Mask|Nasal Pillows mask for the treatment of obstructive sleep apnea (OSA)
16019551|NCT02741622|Behavioral|High aerobic intensity training (HIT)|One training session, high aerobic intensity training (HIT) at 90-95 % of the maximal heart rate (HRmax)
16019552|NCT02741622|Behavioral|Long slow distance training (LSD)|One training session, long slow distance training (LSD) at 70 % of the HRmax
16019553|NCT02741609|Device|Borrelia Diagnostic Test|The ALSI BDT is a high-yield in vitro cultivation method for Borrelia burgdorferi from venous whole blood samples.
16019554|NCT02741596|Drug|DX-2930|Participants who rollover from the DX-2930-03 study will receive 300 milligram (mg) DX-2930 subcutaneous injection at Day 0 followed by second dose following the first HAE attack and then once in every 2 weeks until the end of the treatment period (up to 924 days). A wash-out period of a minimum of 10 days and a maximum of 18 days is required between subsequent administrations.
16019635|NCT02741141|Other|Classical partograph|Classical partograph used as standard care
16089248|NCT02242331|Drug|Micardis®|
16019555|NCT02741596|Drug|DX-2930|Participants who were not participants in DX-2930-03 will receive 300 milligram (mg) DX-2930 subcutaneous injection once in every 2 weeks until the end of the treatment period (up to 924 days).
16019556|NCT02741583|Other|altitude rehabilitation program|altitude exposure
16019557|NCT02741583|Other|rehabilitation program|Rehabilitation at low altitude
16019558|NCT02741570|Biological|Nivolumab|
16019559|NCT02741570|Biological|Ipilimumab|
16019560|NCT02741570|Drug|Cetuximab/Erbitux|
16019561|NCT02741570|Drug|Cisplatin/Platinol|
16019562|NCT02741570|Drug|Carboplatin/Paraplatin|
16019563|NCT02741570|Drug|Fluorouracil/Adrucil|
16019564|NCT02741557|Drug|DTG|DTG is provided as a white, film-coated, round tablet containing DTG 50 mg, debossed with SV 572 on one side and 50 on the other side. Subjects will receive a single oral dose of DTG 50 mg tablet with 240 mL of water.
16019565|NCT02741557|Drug|RPV|RPV is provided as a white to off-white, film-coated, round, biconvex tablet containing RPV 25 mg, debossed with TMC on one side and 25 on the other side. Subjects will receive a single oral dose of RPV 25 mg tablet with 240 mL of water.
16019566|NCT02741557|Drug|DTG/RPV FDC|DTG/RPV FDC is provided as a pink, film coated, oval biconvex tablet containing FDC of DTG 50 mg and RPV 25 mg, debossed with SV J3T on one face. Subjects will receive a single oral dose of DTG/RPV 50 mg/25 mg FDC tablet with 240 mL of water.
16019567|NCT02741531|Other|Bladder filled with saline solution|Patients in this arm will have their bladders filled with 150 cc of saline solution.
16019568|NCT02741531|Other|saline solution|Saline solution will be used to partially fill patients' bladders
16019569|NCT02741518|Biological|Fecal Microbiota Transplantation|This is pre-screened fecal material that has been encapsulated
16019570|NCT02741518|Other|Placebo|These are capsules that have no fecal material in them.
16019571|NCT02741505|Device|Actigraph|Participants will be asked to wear an actigraph
16019572|NCT02741492|Procedure|Transversus Abdominis Plane Block|Continuous Nerve Block
16019573|NCT02741492|Procedure|Sham Block|Continuous Sham Catheter
16019574|NCT02741479|Other|Airplane Test|"The airplane test requires the subject to bend forward, bringing the upper body and one leg horizontal, making a T position with the body with the arms out to the sides while in single-leg stance; they then bend the supporting leg, bringing the finger tips towards the floor, followed by straightening the supporting leg and bringing the arms back out to the sides. This motion is repeated five times on each leg per trial. The airplane will be performed to a metronome to standardize performance time"
16019575|NCT02741466|Drug|Coppertone (BAY987517)|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application. Formulation number - SR16-01.
16019576|NCT02741453|Procedure|Standard Practice|
16019577|NCT02741453|Procedure|Bilateral IJ Ultrasound Scanning|
16019578|NCT02741427|Other|Conventional toothpaste|The participants should brush their teeth with conventional toothpaste for 90 seconds, twice per day, during two weeks.They should place a pea-size amount of toothpaste on their toothbrushes, use dental floss, but not mouth rinse.
16019579|NCT02741427|Other|Whitening toothpaste|The subjects should brush teeth with whitening toothpaste containing blue pigment for 90 seconds, twice per day, during two weeks.They should place a pea-size amount of toothpaste on toothbrushes, use dental floss, but not mouth rinse.
16019580|NCT02741427|Other|10% carbamide peroxide|"The subjects should dispense the bleaching gel at night into the trays (maxillary and mandibular) and to insert them to cover at least the anterior teeth for a period of 4 h per day, over a 2-week period. Both arches should be bleached at the same time. During the period of bleaching, volunteers should receive the same toothpaste used by G1, in other words, without whitening agents, to standardize their oral hygiene regimen"
16019581|NCT02741414|Device|The result of H pylori culture based on gram staining and enzyme activity testing|This intervention aimed at patients with the positive result of 13C-urea breath test. Patients with negative result of H pylori culture was H pylori culture negative group. Patients with positive result of H pylori culture were belonged into the first successful eradication group and the refractory infection of H. pylori group.
16019582|NCT02741414|Device|The result of 13C-urea breath test after treatment based on the selection of clarithromycin, levofloxacin, metronidazole, amoxicillin，tetracycline，furazolidone and the dose of esomeprazole|The intervention focused on the results from the result of 13C-urea breath test after treatment. The first successful eradication group and the refractory infection of H. pylori group were treated according to the antibiotic susceptibility testing and CYP2C19 gene polymorphism. Eight weeks after treatment, a 13C-urea breath test was performed on patients. The first successful eradication group were patients with negative in 13C-urea breath tests in the first treatment. The refractory infection of H. pylori group were treatment failure patients with positive in 13C-urea breath tests after the second standardized treatment.
16019583|NCT02741414|Device|The result of Amoxicillin resistance in vitro based on antibiotic susceptibility testing|The intervention focused on the results from the result of Amoxicillin susceptibility testing in vitro. In this study, the investigators selected the patients with Amoxicillin resistance from the first successful eradication group and the refractory infection of H. pylori group.
16019584|NCT02741401|Other|Usual post-operative care|Usual post-operative care concerning patients who underwent surgery because of gastrointestinal malignancy
16019585|NCT02741401|Other|Hand-foot massage|Hand-foot massage administered during 5 consecutive days postoperatively by trained volunteers, concerning patients who underwent surgery because of gastrointestinal malignancy
16019586|NCT02741388|Drug|selinexor|
16019587|NCT02741388|Drug|Rituximab|
16019588|NCT02741388|Drug|Dexamethasone|
16019589|NCT02741388|Drug|Oxaliplatin|
16019590|NCT02741388|Drug|Cisplatin|
16019591|NCT02741388|Drug|Cytarabine|
16019592|NCT02741388|Drug|Gemcitabine|
16019593|NCT02741375|Device|Somanetics 5100c (Invos oximeter cerebral/somatic Troy, MI, USA)|All patients underwent at least 6-h NIRS monitoring using a Somanetics 5100c (Invos oximeter cerebral/somatic Troy, MI, USA) cerebral oximeter in order to determined cerebral oximetry changes.
16019594|NCT02741362|Other|Intravenous injection of Stromal Vascular Fraction Cells (SVF) containing ADSCs|
16019595|NCT02741362|Other|Lipoaspiration|
16019596|NCT02741336|Behavioral|Cognitive Behavioral Therapy for Insomnia (CBT-I)|"Cognitive-behavioral therapy is a short-term, focused psychotherapy for a wide range of psychological and behavioral issues including depression, anxiety, anger, and non-compliance. The focus of the intervention is on how one thinks, behaves, and communicates in real time, as opposed to a focus on one's early childhood experiences. The therapist assists the patient in identifying specific distortions and biases in thinking and provides guidance on how to modify these beliefs. CBT helps the patient learn effective self-help skills that are used in homework assignments that ultimately help change the way one thinks, feels and behaves. The
~￼ intervention is action-oriented, practical, rational, and helps the patient gain independence and effectiveness in dealing with real-life issues. Techniques utilized in CBT-I include psychoeducation, sleep hygiene, cognitive restructuring, stimulus control, sleep restriction, and relaxation training."
16019597|NCT02741336|Behavioral|Self-Monitoring|
16019598|NCT02741323|Drug|Maraviroc|"Initial dose of 300 mg twice daily (150mg twice daily if co-prescribed with a potent CYP3A inhibitor or 600mg twice daily if co-prescribed with a potent CYP3A inducer). Will be modified if GFR < 30, if co-prescribed with a potent CYP3A inhibitor or inducer, or if the calcineurin inhibitor used for maintenance immunosuppression is changed to cyclosporine (which is only allowed for tacrolimus toxicity).
~Once GFR is greater than or equal to 30, the dose should be returned to the non-renal dosage. If GFR is consistently fluctuating (especially immediately post-transplant), the site investigator may choose when to resume normal dosing of study product based on clinical assessment of stability."
16019599|NCT02741323|Drug|Placebo|"Initial dose of 300 mg twice daily (150mg twice daily if co-prescribed with a potent CYP3A inhibitor or 600mg twice daily if co-prescribed with a potent CYP3A inducer). Will be modified if GFR < 30, if co-prescribed with a potent CYP3A inhibitor or inducer, or if the calcineurin inhibitor used for maintenance immunosuppression is changed to cyclosporine (which is only allowed for tacrolimus toxicity).
~Once GFR is greater than or equal to 30, the dose should be returned to the non-renal dosage. If GFR is consistently fluctuating (especially immediately post-transplant), the site investigator may choose when to resume normal dosing of study product based on clinical assessment of stability."
16019600|NCT02741310|Drug|Placebo|Administered by intravenous infusion
16019601|NCT02741310|Drug|Sumatriptan|Administered by two 6 mg subcutaneous injections 1 hour apart on day 2 and day 5
16019602|NCT02741310|Drug|Erenumab|Administered by intravenous infusion
16019603|NCT02741297|Device|Spinal Cord Stimulation (SCS) System|Boston Scientific (BSC) PRECISION SCS System with MultiWave Technology
16019604|NCT02741284|Drug|Room air|
16019605|NCT02741284|Drug|10L Oxygen by nonrebreather mask|
16019606|NCT02741271|Drug|MF MDI 100 mcg BID (Open Label)|Eligible participants will receive open-label MF MDI 100 mcg BID during a 2-week run-in period.
16019607|NCT02741271|Drug|MF/F MDI 100/10 mcg BID|After a 2 week run-in on open-label MF MDI 100 mcg BID, eligible participants will receive double-blinded treatment with MF/F MDI 100/10 mcg BID.
16019608|NCT02741271|Drug|MF MDI 100 mcg BID|After a 2 week run-in on open-label MF MDI 100 mcg BID, eligible participants will receive double-blinded treatment with MF MDI 100 mcg BID.
16019609|NCT02741271|Drug|Albuterol/Salbutamol PRN|Participants may use study-provided short-acting beta agonist (SABA), albuterol/salbutamol, as needed (PRN) for the relief of asthma symptoms.
16019610|NCT02741271|Drug|Prednisone/Prednisolone|Participants may use a systemic corticosteroid (prednisone/prednisolone) for acute asthma worsening per investigator discretion.
16019611|NCT02741258|Device|Mepitel Film|Placement of Mepitel Film to prevent skin toxicity
16019612|NCT02741258|Drug|skin cream|cream to treat skin erythema due to radiotherapy
16019613|NCT02741245|Drug|Ezetimibe 10 mg|
16019614|NCT02741245|Drug|Rosuvastatin 2.5 mg|
16019615|NCT02741245|Drug|Placebo for Ezetimibe|
16019616|NCT02741245|Drug|Placebo for Rosuvastatin|
16019617|NCT02741232|Drug|Lidocaine 1% with epinephrine 1/400000|
16019618|NCT02741232|Other|sham block|
16019619|NCT02741219|Drug|Normal saline|Control Group receives normal saline bolus after delivery
16019620|NCT02741219|Drug|Dexmedetomidine|Dex Group receives dexmedetomidine bolus 0.5mcg/kg after delivery
16019621|NCT02741219|Drug|Sufentanil|sufentanil PCA after surgery
16019622|NCT02741219|Drug|Sufentanil and dexmedetomidine|sufentanil combined with dexmedetomidine PCA after surgery
16019623|NCT02741206|Behavioral|Bellevue ROSE Intervention|
16019624|NCT02741206|Behavioral|Psycho-education session and usual, Standard of care Control|Psycho Education and usual, standard of care
16019625|NCT02741206|Behavioral|One Psycho-education session and usual, standard of care Control|
16019626|NCT02741193|Device|The Magstim Rapid2,|"Transcranial Magnetic Stimulation, which is a microprocessor-controlled machine which delivers both single and repetitive transcranial magnetic stimulation (TMS).
~single and repetitive transcranial magnetic stimulation (TMS). TMS will be applied as single pulses to determine motor evoked potentials (MEPs), there will be no modulation of cortical excitability."
16019627|NCT02741180|Other|3D Imaging|"roadmapping of electrophysiology (EP) procedures"
16019628|NCT02741180|Other|Late Gadolinium Enhancement (LGE)|useful for delineating abnormal myocardium, including fibrotic regions that can serve as sources of arrhythmias.
16019629|NCT02741167|Procedure|CRS and HIPEC|During CRS, all visible peritoneal tumors are removed. Consequently micrometastasis are removed with hyperthermic intraperitoneal chemotherapy
16019630|NCT02741154|Drug|induction with aromataze inhibitor|letrozole 2.5mg once daily start in the first day of menses for 5days
16019631|NCT02741154|Drug|HMG|HMG 300 IU injection once daily start at first day of menses with follow up by trans vaginal ultrasound (TVUS ) till at least three follicles reach 14 mm in diameter
16019632|NCT02741154|Drug|GnRh a|antagonist given 0.1 ml injection once daily with continous follow up when at least three follicles reach 17mm in diameter HCG 10.000 IU injection and ovum pick up 24-36hours after injection
16019633|NCT02741154|Drug|HCG|10.000 IU HCG injection when at least three follicles reach 17mm in diameter
16019634|NCT02741141|Other|New partograph based on the studies of Neal and Lowe|"The partograph designed by Neal and Lowe includes an action line which if crossed permits an active management of labour.
~Eventually, the only difference between the two arms is the moment when the active management of labour is started.
~The oxytocin is administrated according to the department protocol."
16019638|NCT02741115|Drug|Udenafil|Active drug
16019639|NCT02741115|Drug|Placebo|Matching Placebo
16019640|NCT02741102|Procedure|Uterine Transplant|Treating Absolute Uterine Factor Infertility by Uterus Transplant. Potential recipients undergo IVF to obtain 6 embryos for cryopreservation followed by live donor uterine transplant. After 1 year, embryo transfer is done to achieve pregnancy. Delivery is by Caesarian section. The recipient may have up to 2 children by these methods and then the uterus is removed so that immunosuppression can be stopped.
16019641|NCT02741089|Procedure|Indication for a flexible bronchoscopy|"The data of patients are collected within the hospital routine documentation during the flexible bronchoscopy. The bronchoscopy is performed regardless of this study. Following the bronchoscopy the patients are asked a few questions about their health and their perception.
~The follow-up of all patients is done via phone calls in order to collect data about the outcome of each patient."
16019642|NCT02741076|Drug|Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)|Structured discontinuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)
16019643|NCT02741076|Drug|Continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)|Continuation of opioid therapy (morphine sulfate ER, oxycodone ER, oxymorphone ER)
16019644|NCT02741063|Behavioral|screen low autistic subjects|screen subjects with low ASQ score
16019645|NCT02741063|Behavioral|screen high autistic subjects|screen subjects with high ASQ score
16019646|NCT02741063|Drug|oxytocin|intranasal administration of oxytocin (24 IU)
16019647|NCT02741063|Drug|placebo|intranasal administration of placebo (24 IU)
16019648|NCT02741050|Behavioral|Tailored Physical Activity Intervention|The Tailored Internet intervention is based on constructs of the Transtheoretical Model (TTM) and Social Cognitive Theory (SCT). During the 6-month intervention period, participants will receive monthly mailed questionnaires that assess current motivational readiness for physical activity and other TTM and SCT constructs (e.g., process of change, self-efficacy) and monthly logs to record their current activity.
16019649|NCT02741050|Behavioral|Standard of Care|Those assigned to the control group will continue to receive standard of care through the Family Medicine clinic. This currently entails commonly accepted medication treatment strategies, educational materials and counseling for self-management and medication adherence, screening for depression or other conditions that would impair self-management, and national and state quality of care guidelines for lab testing and control targets (HbA1c, lipids, blood pressure). Participants in the control group will also receive monthly questionnaires on topics other than physical activity (e.g. diet) to fill out and return in order to have the same opportunities for compensation as those in the intervention condition.
16019650|NCT02741037|Behavioral|Dyadic lifestyle intervention|Dyadic lifestyle intervention: The dyadic behavioral lifestyle intervention was modeled after the Diabetes Prevention Program (DPP), and was adapted to make it more easily accessible to low-income Latinas. In addition, this intervention arm has a dyadic component to examine the effectiveness of mothers and daughters engaging in the lifestyle intervention together as partners. Participants also will receive usual care.
16019651|NCT02741037|Behavioral|Individual lifestyle intervention|Individual lifestyle intervention: The individual behavioral lifestyle intervention was modeled after the Diabetes Prevention Program, and was adapted to make it more easily accessible to low-income Latinas. Mothers participate in the Unidas intervention alone, without their related daughters. Unrelated daughters participate in the Unidas intervention alone without their related mothers. Participants also will receive usual care.
16019652|NCT02741037|Other|Usual Care|Usual Care: Mother and daughter participants will receive Usual Care.
16019653|NCT02741024|Drug|Amodiaquine-Artesunate (ASAQ)|Treatment on site with Amodiaquine-Artesunate according to the manufacturer's dose and instruction and follow-up for a period of 42 days. Drugs will be given under direct supervision, either at the clinic or at home
16019654|NCT02741024|Drug|Artemether-Lumefantrine (AL)|Treatment on site with Artemether-lumefantrine combination according to the manufacturer's dose and instruction and follow-up for a period of 42 days.
16019655|NCT02741011|Other|Radiological examination|During the period of two years, mentally handicapped patients were enrolled in this study. First a radiological examination was performed under sedation anesthesia and then an oral examination was performed when patient underwent general anesthesia for dental treatments. Oral and radiological examinations were compared with each other and also with treatment results to define the necessity of the radiological examination of mentally handicapped patients.
16019656|NCT02740985|Drug|AZD4635|AZD4635 will be administered orally as a nanosuspension or capsule on a continuous schedule in Arms A, B, C, D, E, F, G, H, I, J, K, KD, L, AA, and EA. The AZD4635 nanoparticle drug product will be constituted extemporaneously as an oral suspension by the patient immediately prior to dosing. In Arms CA, CB, and CC AZD4635 will be administered as 75 mg or 50 mg capsules. Additionally, in Arm CA, AZD4635 will also be administered at 150 mg and 200 mg, or a lower dose of 125 mg or 100 mg may be given.
16019657|NCT02740985|Drug|Durvalumab|Durvalumab will be administered by intravenous infusion once every 4 weeks. Durvalumab should be reconstituted using aseptic techniques with sterile water for injection. The reconstituted solution will be diluted with 0.9% (w/v) saline prior to IV infusion.
16019658|NCT02740985|Drug|Abiraterone Acetate|"Abiraterone acetate 1000 mg PO QD will be given with prednisone BID. The patient must receive abiraterone/prednisone according to the prescribing information during the DLT assessment period, Cycle 1 and Cycle 2. After Cycle 2 necessary abiraterone/ prednisone dose modifications may follow institutional standard practice.
~Abiraterone acetate is supplied in 250 mg tablets."
16019659|NCT02740985|Drug|Enzalutamide|"Enzalutamide 160 mg PO QD will be dosed per the approved package insert. The patient must receive enzalutamide according to the prescribing information during the DLT assessment period, Cycle 1 and Cycle 2. After Cycle 2 necessary enzalutamide dose modifications may follow institutional standard practice.
~Enzalutamide is supplied as 40 mg soft gelatin capsules."
16019660|NCT02740985|Drug|Oleclumab|Oleclumab 1500 mg will be given by IV infusion on Days 1 and 15 of each cycle.
16019717|NCT02740595|Other|one time exposure to e-cig without nicotine|one time exposure to e-cig without nicotine
16019718|NCT02740595|Other|one time exposure to empty e-cig|one time exposure to empty e-cig (sham control
16019719|NCT02740582|Drug|Tolcapone|
16019720|NCT02740582|Drug|Placebo|
16019661|NCT02740985|Drug|Docetaxel|"Patients in Cohort CC will receive docetaxel 75 mg/m² by IV infusion according to institutional standards of practice on Day 1 of each treatment cycle. If a patient's body surface area is greater than 2.2 m², the docetaxel dose will be adjusted to a body surface area of 2.2 m².
~The patient should be pre-medicated with oral dexamethasone 8 mg (or equivalent) twice daily starting the day prior to treatment for a total of 3 days, or according to institutional standards of practice."
16019662|NCT02740972|Drug|NS-065/NCNP-01|
16019663|NCT02740972|Drug|Placebo|
16019664|NCT02740959|Drug|Astragalus Polysaccharides 500 mg|PG2 Injection 500 mg PG2 (500 mg in 500 ml saline), t.i.w. via i.v. infusion for 2.5-3.5 hours over 2 treatment cycles (8 weeks)
16019665|NCT02740959|Drug|Astragalus Polysaccharides 250 mg|PG2 Injection 250 mg PG2 (250 mg in 500 ml saline), t.i.w. via i.v. infusion for 2.5-3.5 hours over 2 treatment cycles (8 weeks)
16019666|NCT02740946|Other|Exercise therapy|5 months of exercise therapy with two strengthening exercises focusing on m. deltoideus anterior and m. teres minor. Furthermore, a warm up exercise was applied.
16019667|NCT02740933|Drug|Demeclocycline|
16019668|NCT02740920|Drug|Pembrolizumab|
16019669|NCT02740920|Procedure|CT Scan|
16019670|NCT02740907|Procedure|premolar autotransplantation|Autogenous tooth transplantation of premolars to the anterior maxilla to stimulate bone and soft tissue growth.
16019671|NCT02740894|Drug|Gefitinib|
16019672|NCT02740881|Other|Counselor Training Methods|
16019673|NCT02740868|Drug|Xenon-129|Xenon gas to be inhaled by research participants
16019674|NCT02740868|Device|Magnetic Resonance Imaging|Lung imaging will be performed for participants using MRI for all 3 arms
16019675|NCT02740868|Device|Lung Clearance Index|Lung clearance index (measure of lung health) will be performed for all participants of all 3 arms
16019676|NCT02740855|Device|Alcomed 3011®|Endtidal ethanol measurement
16019677|NCT02740842|Behavioral|Interpersonal behavioral change communication|This arm includes home visits to mothers with infants and young children. Frontline health workers will counsel and support mothers in relation to breastfeeding and complementary feeding practices
16019678|NCT02740842|Behavioral|Mass media|A nationwide mass media campaign of TV and radio spots on infant and young child feeding practices will be aired in 2011, 2012 and 2013. All intervention arms will be exposed to this campaign.
16019679|NCT02740829|Drug|Intranasal glucagon|Glucagon will be administered via a nasal dispenser
16019680|NCT02740829|Drug|Intranasal placebo|Placebo
16019681|NCT02740816|Other|Comparative blood analysis|Collection of menstrual blood and systemic blood
16019682|NCT02740803|Other|Sodium fluoride toothpaste 1,450 ppmF|
16019683|NCT02740803|Other|sodium monofluorophosphate toothpaste 1,450 ppmF|
16019684|NCT02740803|Other|stannous fluoride combined with sodium fluoride toothpaste 1,450 ppmF|
16019685|NCT02740803|Other|sodium fluoride combined sodium monofluorophosphate toothpaste 1,450 ppmF|
16019686|NCT02740803|Other|Amine fluoride toothpaste 1,400 ppmF|
16019687|NCT02740803|Other|Non-fluoridated toothpaste 0 ppmF|
16019688|NCT02740790|Biological|HPV vaccine|Subjects were planned to receive HPV vaccine 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
16019689|NCT02740790|Biological|Placebo|Subjects were planned to receive three doses of the placebo control 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
16019690|NCT02740777|Biological|HPV-16/18 vaccine|HPV 16 L1 virus like particles (VLP) 40μg; HPV 18 L1 VLP 20μg; Aluminium phosphate 225μg; NaCl 0.32M; Histidine buffer 10mM; Tween-80 0.01%.
16019691|NCT02740764|Other|Optimization of drug prescribing|The patients included in this group will have the intervention. The optimization of drug prescribing consists to a history of the drugs prescribing leading to pharmaceutical recommendations by the pharmacist-clinician, accepted by the specialist physicians in charge of the patient at the hospital and sent to the referring physicians of patients, who can accept or not the recommendations.
16019692|NCT02740751|Dietary Supplement|Still-Tee|The mothers of the babies will receive Still-Tee galactogogue tea
16019693|NCT02740738|Device|Wagner Pain Algometer|applied at a 90 degree angle to the skin at a constant rate of 10kPa/s to minimize the impact of the examiner's reaction time on recorded pain thresholds
16019694|NCT02740738|Device|Dynamometer|Dominant Hand Grip strength measured by the average of 3 attempts
16019695|NCT02740725|Other|Patching Therapy|Occlusion of a dominant eye with better best corrected visual acuity
16019696|NCT02740725|Device|Interactive Binocular Treatment System|Dissociation of two eyes with more foveal stimulation to the amblyopic eye
16019697|NCT02740712|Drug|Caffeine|200 mg (4 x 50mg) Tablet
16019698|NCT02740712|Drug|Warfarin|10 mg (2 x 5mg) Tablet
16019699|NCT02740712|Drug|Omeprazole|40 mg Tablet
16019700|NCT02740712|Drug|Midazolam|5 mg/mL
16019701|NCT02740712|Drug|digoxin|.25 mg Tablet
16019702|NCT02740712|Drug|Vitamin K|10 mg Tablet
16019703|NCT02740712|Drug|Rucaparib|200 & 300 mg tablet
16019706|NCT02740686|Other|Sample collection|Frequent exacerbators and infrequent exacerbators will have blood and sputum samples obtained around pulmonary rehabilitation. No other intervention will be administered. Healthy controls will have resting blood samples taken.
16019707|NCT02740673|Device|Driving simulator|Patients are asked to use a driving simulator to test their driving skills
16019708|NCT02740660|Drug|Caffeine 100mg / Albuterol 4mg|
16019709|NCT02740660|Drug|Placebo|
16019710|NCT02740660|Behavioral|Family weight management counseling|
16019711|NCT02740647|Drug|Amoxicillin Clavulanate|getting intra-venous1GR Amoxicillin Clavulanate 3 times a day for 5 days post surgery
16019712|NCT02740647|Drug|Placebo|50 ml of 0.9% sodium chloride three times a day
16019713|NCT02740634|Drug|F-18 AV 1451|Tau binding agent
16019714|NCT02740634|Drug|C-11 PiB|Amyloid binding agent
16019715|NCT02740608|Device|OrganOx metra|Normothermic Machine Liver Perfusion
16019716|NCT02740595|Other|one time exposure to e-cig with nicotine|one time exposure to e-cig vapor with nicotine
16019839|NCT02739581|Other|Placebo|
16019721|NCT02740569|Other|No intervention|Observational study. Intervention according to the clinical routines (not included in this part)
16019722|NCT02740556|Other|HepCure ToolKit|"HepCure is a web-based tool kit in the form of a dashboard for providers and an application (or app) for patients. The app allows patients to become active participants in their treatment by enabling them to enter prescribed treatment, add medications to Pill Box, log doses, visualize adherence, and includes several additional resources."
16019723|NCT02740556|Device|AdhereTech Active Features|AdhereTech, a wireless pill monitoring device that measures the dosage and time a medication was taken. It is a HIPAA-compliant, FDA-registered Class I medical device. Using cellular technology, AdhereTech can be used passively to collect data on when a medication is taken, when a refill is needed, and how often the bottle is opened. AdhereTech also can be used actively to monitor adherence and provide feedback to subjects using the device. When actively monitoring, AdhereTech can be set up to provide live feedback to a subject by lighting up, sounding chimes, and sending phone/text/email alerts to remind patients to take their medication.
16019724|NCT02740556|Other|AdhereTech Passive Monitoring|AdhereTech passively monitors adherence (no chimes or reminders)
16019725|NCT02740543|Drug|Fluticasone propionate HFA 220|Subjects will take two (2) puffs of Fluticasone propionate HFA 220 twice a day.
16019726|NCT02740530|Device|Magstim® Rapid 2 machine|See Arms description
16019727|NCT02740491|Other|Remission Consultation|"At the end of adjuvant treatment (adjuvant chemotherapy and / or radiotherapy), the patient is seen by a referent oncologist and included in the study. A Remission consultation with a psychotherapist is then proposed and its purpose explained to the patient. The patient agrees or refuses take advantage of the Remission consultation; in case of refusal, the reasons are documented and further information is provided, thus giving the opportunity for the patient to benefit from further psychological counseling if desired.
~If approval is given, the patient will be scheduled for the Remission consultation (duration 1 hour) . The latter includes a first phase evaluating the mental state of the patient, and then a proposal of individualized care if necessary and according to several methods, depending on the choice of the patient."
16019728|NCT02740465|Behavioral|Anxiety Inventory for Respiratory Disease (AIR)|An initial version of the AIR was developed through a mixed-methods approach to item development, incorporating both emic and etic perspectives. This included an extensive review of extant anxiety scales (etic perspectives) and in-depth qualitative interviews with patients with COPD and self-reported anxiety (emic perspectives). AIR has ten items on a scale from 0 to 3. It provides a score of 0-30. High score indicates elevated level of clinically relevant anxiety symptoms.
16019729|NCT02740465|Behavioral|Hospital Anxiety and Depression Scale (HADS)|The Hospital Anxiety and Depression Scale (HADS), a self-assessment scale, was developed to detect states of depression, anxiety and emotional distress amongst patients who were being treated for a variety of clinical problems.
16019730|NCT02740452|Device|ligamys technique|Ligamys technique (device) or standard technique
16019731|NCT02740452|Other|standard technique (anatomic reconstruction)|Ligamys technique (device) or standard technique
16019732|NCT02740439|Other|Avocado|The intervention meals will contain 1 large avocado.
16019733|NCT02740439|Other|Control|The control meals will be isocaloric to the intervention meals but will not contain avocado.
16019734|NCT02740426|Drug|Pirarubicin|single immediate intravesical dose of pirarubicin (THP) intravesical therapy (THP 40 mg for 30 min) within 24 hours of ureteroscopy.
16019735|NCT02740400|Procedure|EBUS-GS|The equipment for EBUS-GS includes super-thin bronchoscope BF-P260F, endobronchial ultrasonic system EU-M30S, ultrasonic probe UM-S20-17S, and guided sheath kit K201. All facilities are provided by Olympus Co. The EBUS-GS procedure was performed by thoracic surgeons. The patient was in supine position, under general anesthesia, and provided ventilatation through laryngeal mask. First, the operator placed super-thin bronchoscope into the bronchus of interest, inserted the probe covered with GS through a work channel. Later, adjusted the bronchoscope and probe to obtain classical ultrasonic graphs. The assistant fixed the bronchoscope, pulled the probe out, and placed the brush and biopsy forceps, respectively, through the GS. This process was assisted using x-ray fluoroscope or not.
16019736|NCT02740400|Procedure|CT-TTNB|The devices for CT-TTNB includes Lightspeed VCT spiral CT(GE co.) and Quickcore(COOK Co.) biopsy kit. The kit includes a sheath(5cm in length and 16G in outer diameter) and a automatic biopsy needle(15cm in length and 18G in outer diameter). The patient stays in supine, prone or lateral position according to the lesion's location. The first chest CT scan is performed to confirm the location of the lesion and make an optimal entry point. Then, after sterilization and 2% lidocaine local anesthesia, the sheath is stabbed into chest wall through the entry point. The second CT scan is performed to make sure that the sheath stays in proper angle and depth. The operator places the needle through the sheath and enter the lesion. Then fire the biopsy needle and repeat the procedure twice or third time. The last CT scan is conducted to determine whether pneumothorax or hemorrhage occurred.
16019737|NCT02740387|Drug|OTO-104|
16019738|NCT02740374|Device|ROTEM|ROTEM coagulation assessment and guided transfusion management.
16019739|NCT02740374|Other|Standard of Care|Standard Coagulation Tests assessment and guided transfusion management
16019740|NCT02740361|Behavioral|Deprexis, DeprexisPlus|Online program Deprexis, either as a stand-alone internet-based intervention (Deprexis) or with added standardized email support by a clinical psychologist (DeprexisPlus). In this trial, we will use a Version of Deprexis that has been adapted to MS-specific needs.
16019741|NCT02740348|Behavioral|ZocDoc Assistance|Research assistant sets up a follow-up appointment for a subject with a primary care doctor using ZocDoc
16019742|NCT02740348|Behavioral|ZocDoc Information|Providing ZocDoc information to subjects so that they can make a follow-up appointment with a primary care doctor themselves
16019743|NCT02740335|Drug|Octaplex|OCTAPLEX will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (~3 units/kg/min), up to a maximum rate of 8.4 mL/min (~210 units/min).
16019744|NCT02740335|Drug|Beriplex P/N (Kcentra)|Beriplex® P/N (Kcentra) will be administered by intravenous infusion at a rate of 0.12 mL/kg/min (~3 units/kg/min), up to a maximum rate of 8.4 mL/min (~210 units/min).
16019745|NCT02740322|Procedure|Hum Test|The subject will be brought into an exam room. The subject will then be asked to hum for a few seconds in a low pitch. They will then be asked if the nose was heard more so in one ear compared to the other. The subject will then be asked to hum for a few seconds in a high pitch. They will then be asked again if the noise was heard more so in one ear compared to the other.
16019746|NCT02740322|Procedure|Weber Test|Using a 512 Hz tuning fork, the tuning fork will be vibrated and placed on the subject's glabella (forehead landmark). The subject will then be asked if the vibration was heard more so in one ear compared to the other.
16019747|NCT02740322|Device|Audiogram|A standard audiogram will be administered by an audiologist.
16019748|NCT02740309|Behavioral|Integrated Brief Behavior Therapy (IBBT) Intervention|The 4 sessions will empower and support families and youth to continue treatment autonomously with home practice
16019749|NCT02740309|Behavioral|Treatment as usual|Facilitated community referral for mental health treatment
16019750|NCT02740296|Other|No intervention|
16019751|NCT02740283|Behavioral|glycemic monitoring|
16019752|NCT02740283|Dietary Supplement|dietary guide|
16019753|NCT02740270|Drug|GWN323|
16019754|NCT02740270|Drug|PDR001|
16019755|NCT02740257|Other|Photos|Photos will be taken of skin lesion markings using a smart phone or tablet
16019756|NCT02740244|Device|active iTBS|Transcranial magnetic stimulation. MagProX100 (MagVenture, Denmark) with a figure-eight coil (MCF-B65)
16019757|NCT02740244|Device|sham iTBS|Transcranial magnetic stimulation. MagProX100 (MagVenture, Denmark) with a sham figure-eight coil (MCF-P-B65)
16019758|NCT02740231|Drug|JTA-004 intra-articular injection|Each patient will undergo a single injection of JTA-004 into the knee joint
16019759|NCT02740231|Device|Reference product intra-articular injection|Each patient will undergo a single injection of Reference product into the knee joint
16019760|NCT02740218|Other|Patient questionnaire|Patients will be asked to complete a questionnaire regarding their expectations, experience and satisfaction in taking OTEZLA (apremilast) treatment
16019761|NCT02740205|Other|Algorithm for enteral nutrition support|Enteral nutrition support prescribed by the Clinical Nutrition Service under the instructions of the algorithm based on evidence
16019762|NCT02740192|Procedure|Adductor Canal Block|Post-op adductor canal block using Bupivacaine
16019763|NCT02740192|Procedure|Periarticular Injection|Intra-op periarticular injection of Ropivacaine
16019764|NCT02740192|Drug|Ropivacaine|Ropivacaine was used for the periarticular injection
16019765|NCT02740192|Drug|Bupivacaine|Bupivacaine was used for the periarticular injection
16019766|NCT02740179|Drug|Eplerenone|Eplerenone 50mg by mouth twice daily
16019767|NCT02740179|Drug|Placebo|Placebo by mouth twice daily
16019768|NCT02740179|Behavioral|Lifestyle Modification|Counseling regarding diet and healthy activity
16019769|NCT02740166|Drug|propranolol|Patients randomized to propranolol group continue propranolol after eradication of esophageal varices.
16019770|NCT02740153|Other|No Intervention Given|
16019771|NCT02740127|Procedure|Caudal Nerve Block (CNB)|General anesthesia given in the OR using Propofol titrated for induction. CNB given as bolus injection into the caudal canal in the operating room (OR) by attending anesthesiologist using 1% Ropivacaine (max 5mg/kg) + 1:400,000 Epinephrine + Decadron 10 mg + Clonidine 100 mcg.
16019772|NCT02740127|Drug|Ropivacaine|Ropivacaine 1 % (max 5mg/kg) by bolus injection given by anesthesiologist in OR.
16019773|NCT02740127|Drug|Epinephrine|Epinephrine 1:400,000 by bolus injection given by anesthesiologist in OR.
16019774|NCT02740127|Drug|Decadron|Decadron 10 mg by bolus injection given by anesthesiologist in OR.
16019775|NCT02740127|Drug|Clonidine|Clonidine 100 mcg by bolus injection given by anesthesiologist in OR.
16019776|NCT02740127|Drug|Propofol|General anesthesia given in the OR using Propofol titrated for induction.
16019777|NCT02740127|Behavioral|Phone Call|Study staff calls participant about 3 days after surgery to ask about their pain, amount of pain drugs they have taken, and how satisfied they are with the type of anesthesia and pain control they received. This call should last about 5-10 minutes.
16019783|NCT02740101|Drug|oxytocin treatment|intranasal administration of oxytocin (40 IU)
16019784|NCT02740101|Drug|placebo treatment|intranasal administration of placebo (40 IU)
16019785|NCT02740088|Other|Imaging test: 18F-NaF PET/CT|18F-NaF PET/CT as an imaging test
16019786|NCT02740062|Device|NIBS system for evaluation and non invasive current stimulation|
16019787|NCT02740049|Drug|VR588|Evaluation of the efficacy of a novel JAK/STAT inhibitor, VR588, in isolated epithelial cells from asthma patients
16019788|NCT02740036|Device|Hearing Aid (Successor of Phonak Audéo V90)|Successor of Phonak's Receiver-In-the-Canal (RIC) hearing aid Audéo V90.
16019789|NCT02740023|Device|Hearing Aid (Phonak Audéo V90-13)|Phonak's Receiver-In-the-Canal (RIC) hearing aid Audéo V90-13 will be fitted to the participants individual Hearing loss.
16019790|NCT02740023|Device|Hearing Aid (Successor of Phonak Audéo V90-13)|The successor of Phonak's Receiver-In-the-Canal (RIC) hearing aid Audéo V90-13 will be fitted to the participants individual Hearing loss.
16019791|NCT02740010|Device|EDOF Mini WELL Ready IOL|implant
16019792|NCT02739997|Drug|MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g)|MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) administered as an intravenous (IV) infusion
16019793|NCT02739997|Drug|metronidazole 500 mg|metronidazole 500 mg administered as an IV infusion
16019794|NCT02739984|Biological|Evolocumab|Administered by subcutaneous injection with an automated mini doser
16019795|NCT02739984|Drug|Placebo to Evolocumab|Administered by subcutaneous injection with an automated mini doser
16019796|NCT02739971|Behavioral|Low AGEs diet|Oral and written instructions on how to reduce AGEs in diet, mainly by changing cooking methods in addition to standard of care dietary guidance for type 2 diabetes
16019797|NCT02739971|Behavioral|Standard of care dietary guidance for Type 2 diabetes|Oral and written instructions for standard of care dietary guidance for type 2 diabetes
16089249|NCT02242318|Drug|Telmisartan|
16019798|NCT02739958|Drug|Propofol group|Anesthesia is maintained with continuous infusion of propofol 1.5-2mg/kg/h and dexmedetomidine 0.2-1ug/kg/h.
16019799|NCT02739958|Drug|Isoflurane group|Anesthesia was maintained with isoflurane at a concentration of 2-2.5%. fentanyl 50 ug increments
16019800|NCT02739945|Procedure|Cubital tunnel release|The ulnar nerve is decompressed proximally at the intramuscular septum, decompressed more distally through the cubital tunnel and then exposed between the two heads of the flexor carpi ulnaris muscle. Care is taken to ensure that any point that might compress the ulnar nerve either proximally or distally is evaluated.
16019801|NCT02739906|Drug|BioChaperone Human Insulin (HinsBet®)|BioChaperone Human Insulin (HinsBet®) individualised single subcutaneous injection followed by test meal intake
16019802|NCT02739906|Drug|Insulin Lispro (Humalog®)|Insulin Lispro (Humalog®) individualised single subcutaneous injection followed by test meal intake
16019803|NCT02739906|Drug|Regular human insulin (Huminsulin® Normal)|Regular human insulin (Huminsulin® Normal) individualised single subcutaneous injection followed by test meal intake
16019804|NCT02739893|Procedure|Scope Guide Assist|"Olympus has developed a new instrument which provides physicians a real-time, three dimensional visualization of position and configuration during colonoscopy. The Olympus ScopeGuide technology has received FDA clearance and can be used within the United States. The new technology called the 'scopeguide' has been developed that uses magnetic coils embedded into the scope to create a 3 D image of the shape of the entire scope inside the body that is projected onto the monitor to see. This acts as a GPS and shows the advancement of the scope through bends providing information on loops and thereby eliminating chances of loop formation, helping in loop reduction and also reducing the number of external maneuvers that may be required for the completion of colonoscopy."
16019805|NCT02739893|Procedure|Standard procedure for colonoscopy|
16019806|NCT02739880|Device|DESIRIAL® (Intra-mucosal Injections of Cross-linked Hyaluronic Acid)|"Multi-point Intra-mucosal Injections of Cross-linked Hyaluronic Acid (DESIRIAL®) in the Vaginal Vestibule
~The intervention is Intended for intra-mucosal injection in women for biostimulation / rehydration of the surface layers of the lining of the genital areas, vaginal hypotrophies and / or treatment of female sexual dysfunction related to subsidence G spot or area of Gräfenberg .
~Following disinfection and topical anesthesia (lidocaine gel), the vesitbule is injected using a multi-point technique. The optimal volume of DESIRIAL® to be used for injection into the vestibule is approximately 0.3 ml in total."
16019807|NCT02739841|Other|Ventilator hyperinflation|4 sets of 6 hyperinflation breath were applied by mechanical ventilator at 150% of tidal volume (VT) at initial.
16019808|NCT02739841|Other|Chest physical therapy|The patient will be received vibration and passive of the both upper extremity.
16019809|NCT02739828|Biological|Adalimumab|Adalimumab
16019810|NCT02739815|Drug|Normal Saline containing a prophylactic Antibiotic 1 g|500 ml of normal saline containing a prophylactic Antibiotic 1 g.
16019811|NCT02739815|Drug|Tranexamic Acid|Tranexamic acid
16019812|NCT02739802|Drug|Coppertone(BAY987517)|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.Formulation number - SR16-02.
16019813|NCT02739789|Device|tDCS|tDCS
16019814|NCT02739789|Device|Sham tDCS|Sham tDCS
16019815|NCT02739776|Device|Thermographic imaging|Using infrared-recording camera will obtain thermographic images of the lower extremities before and after the epidural blockade
16019816|NCT02739763|Biological|Plasmodium falciparum sporozoite (PfSPZ)|Plasmodium falciparum sporozoites
16019817|NCT02739750|Other|No intervention|There is no intervention for this study. It is a MRS.
16019818|NCT02739737|Other|Blinded manuscript|Blinded version of sham manuscript
16019819|NCT02739737|Other|Unblinded manuscript|Unblinded version of sham manuscript
16019820|NCT02739724|Procedure|Adnexal surgery|
16019821|NCT02739711|Drug|Glycoprotein IIb/IIIa inhibitors|Glycoprotein IIb/IIIa inhibitors intravenous bolus followed by an intravenous infusion for 12/18 h plus medical standard therapy
16019822|NCT02739698|Drug|Paclitaxel|
16019823|NCT02739698|Procedure|Radical surgery-peritonectomy|
16019824|NCT02739685|Device|Everolimus-eluting bioresorbable vascular scaffold|Implantation of everolimus-eluting bioresorbable vascular scaffold in chronic total occlusion
16019825|NCT02739685|Device|Everolimus-eluting stent|Implantation of everolimus-eluting stent in chronic total occlusion
16019826|NCT02739672|Drug|TAH Tablet (Telmisartan/Amlodipine besylate/Hydrochlorothiazide)|Telmisartan 80.0 mg, Amlodipine besylate 13.87 mg (Amlodipine 10 mg), Hydrochlorothiazide 25 mg combination-drug would be administered orally once
16019827|NCT02739672|Drug|TWYNSTA(Telmisartan+Amlodipine besylate)|TWYNSTA 2 Tab. 40/5mg(Telmisartan 40 mg, Amlodipine besylate 6.935 mg(Amlodipine 5 mg) would be administered orally once
16019828|NCT02739672|Drug|Hydrochlorothiazide|Dichlozid 1 Tab.(Hydrochlorothiazide 25.0 mg) would be administered orally once
16019829|NCT02739659|Device|carbon-ion radiotherapy|
16019830|NCT02739646|Device|Functional MRI scan|7.0 Tesla functional MRI scan
16019831|NCT02739633|Drug|Genexol-PM|125 mg/m2 given intravenously over 60 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity.
16019832|NCT02739633|Drug|Gemcitabine|1000 mg/m2 given intravenously for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity.
16019833|NCT02739620|Device|Neuromuscular electrical stimulation|Neuromuscular electrical stimulation will be performed 5 times/week for one hour each day for 2 months.
16019834|NCT02739607|Behavioral|Transdiagnostic program|This transdiagnostic program is based on the general Cognitive Behavioral Therapy (CBT) principles and targets core higher order factors such as negative affectivity and emotion dysregulation, using common intervention techniques applicable across disorders. The program was designed to directly address the aversive emotional experiences often reported by clients, hoping to reverse participants' maladaptive thinking style and dysfunctional behaviors.
16019835|NCT02739594|Drug|Ibandronate|Ibandronate will be administered via 15-minute intravenous (IV) infusion as 6 milligrams (mg) every 4 weeks for 92 weeks.
16019836|NCT02739594|Drug|Zoledronate|Zoledronate will be administered via 15-minute IV infusion as 4 mg every 4 weeks for 92 weeks.
16019837|NCT02739581|Procedure|Endoscopic Variceal Ligation|
16019838|NCT02739581|Drug|Non selective beta blocker|
16019844|NCT02739542|Drug|Tecfidera|Blinded drug wallets will be dispensed during routine study appointments in 3 month supply, so that compliance can be reconciled at follow up visits and telephone consultations, and recorded in accountability logs.
16019845|NCT02739542|Drug|Placebo|Blinded drug wallets will be dispensed during routine study appointments in 3 month supply, so that compliance can be reconciled at follow up visits and telephone consultations, and recorded in accountability logs.
16019846|NCT02739529|Drug|Genexol-PM|Cremophor EL-free polymeric micelle of paclitaxel
16019847|NCT02739516|Drug|Human chorionic gonadotropin|In letrozole stimulated cycle; Human chorionic gonadotropin ( hCG) 10000 IU was given intramuscular when the mean ovarian follicle diameter was ≥18 mm.
16019848|NCT02739516|Drug|FSH co-trigger|In letrozole stimulated cycle; FSH (urofollitropin; Fostimon, IBSA, Bazel, Swiz; 75 IU amp) 150 IU injected once intramuscular when the mean ovarian follicle diameter was ≥18 mm.
16019849|NCT02739516|Drug|Letrozole|Letrozole oral tablets (Femara 2.5 mg tablet; Novartis Pharma Services, Switzerland) 2.5 mg tab twice daily for 5 days from cycle day 3.
16019850|NCT02739503|Device|Ultrasound|Patients will receive ultrasound in the ultrasound unit at Hillel Yaffe Medical Center within 10 days before onset of induced or spontaneous labors. The ultrasound team has been trained in FHC , Estimated Fetal Weight (EFW) and Biparietal Diameter (BPD) measurement .Optimal ultrasound measurements of FHC and BPD will be obtained. The average of 3 fetal head circumference measurements will be recorded. Investigators consider the FHC and BPD to be optimal when a clear outline of the entire fetal skull is measured, and the landmarks (the thalamus, cavum septum pellucidum and choroid plexus in the atrium of the lateral ventricles) are visualized. Subsequent information of labor outcome as well as normal head circumference ,post-delivery will be obtained from maternal and neonatal medical records.
16019851|NCT02739490|Procedure|Core Training Group|Performs oriented exercise segmental stabilization lumbar-pelvic.
16019852|NCT02739477|Drug|Favipiravir|"Cohort 1: Day 1 (inclusion) 4800 mg (2400 mg bid). Day 2 to Day 14: 3600 mg (1800 mg bid).
~Cohort 2: Day 1 (inclusion) 4800 mg (2400 mg bid). Day 2 to Day 14: 3600, 4200, 4800 mg per day depending on cohort 1 results.
~Cohort 3: Day 1 (inclusion) 4800 mg (2400 mg bid). Day 2 to Day 14: 3600, 4200, 4800 mg per day depending on cohorts 1 and 2 results."
16019853|NCT02739464|Other|Exercise + SOC PT/OT|
16019854|NCT02739464|Other|SOC PT/OT|
16019855|NCT02739451|Procedure|standard oxygen|"Devices used to treat spontaneously ventilating patients in the ICU who require supplemental oxygen. They deliver either
~low-flow oxygen [including nasal cannula, Ventimask® without Venturi effect, and non-rebreather mask]
~or medium-flow oxygen [Venturi masks and medium-flow facemasks]"
16019856|NCT02739451|Procedure|HFNO|The intervention is the use of a device that allows to deliver high flow humidified and warmed oxygen. The device used is the Optiflow™ (Fisher&Paykel, Courtaboeuf, France).
16019857|NCT02739438|Other|Electronic cigarette use|Subjects who use electronic cigarettes daily and have not used conventional cigarettes in the previous 3 months.
16019858|NCT02739438|Other|Cigarette use|Subjects who smoke at least ¼ pack cigarettes per day for the past 1 year, with no history of electronic cigarette use in the last 30 days.
16019859|NCT02739438|Other|Control group|Subjects with no history of prior conventional cigarette (< 100 cigarettes lifetime) or electronic cigarette use.
16019860|NCT02739425|Device|Sentimag Device|The programme will compare the Sentimag with the conventional sentinel lymph node detection with radioactive tracer combined with blue dye (in centres using the combined technique) and thereby determine whether the new technique is equivalent to the standard technique for SLNB
16019861|NCT02739412|Biological|Interleukin-2|Subjects will self-administer low dose IL-2 as subQ injection (0.30 MIU per meter squared body surface area) for 4 weeks.
16019862|NCT02739399|Drug|Phenylephrine|Intravenous administration
16019863|NCT02739386|Biological|Ipilimumab|Intravenous monoclonal antibody injection
16019864|NCT02739373|Drug|BMS-986189|
16019865|NCT02739373|Other|Placebo|
16019866|NCT02739360|Drug|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily
16019867|NCT02739347|Device|Active Trans-cranial direct-current stimulation|Active stimulation group will receive 20 min of 2 mA direct current stimulation.
16019868|NCT02739347|Device|Sham Trans-cranial direct current stimulation|This will be an active sham involving brief (15 msec) low current (0.11 mA) pulses every 550 ms.
16019869|NCT02739334|Behavioral|ENRICH|The intervention, called ENRICH (Encouraging Nurturing Responsiveness to Improve Child Health), is a 10-week home-based parent-centered curriculum designed to facilitate parents' mastery of skills for interacting with their toddler to increase opportunities for healthy eating and activity. Each weekly session is a 60 minute session implemented by a trained coach.
16019870|NCT02739334|Behavioral|Control - monthly handouts|The control group receives monthly handouts (one per month) for 3 months that provides information on various topics including child cognitive and language development and child behaviors as it pertains to 2 and 3 year old children.
16019871|NCT02739321|Device|Sound to Sleep System|Sound to Sleep System is a minimal risk device that is embedded in a mattress boxspring. The device syncs with an audio input and emits tactile vibrations in sync with the audio input.
16019872|NCT02739308|Other|Proprioceptive Training|In this study the training program will be developed for 12 weeks and will be applied during the heating of the athletes , three times a week and the duration of each session is 30 minutes. Each week will be chosen three of the 14 exercises adapted for fencing athletes , and preferably one of each category.
16019873|NCT02739308|Other|Control Group|The control group will not make the intervention and will continue with usual training fencing.
16019874|NCT02739295|Drug|recombinant granulocyte - colony stimulating factor|
16019875|NCT02739295|Drug|NaCl 0.9%|
16019876|NCT02739282|Other|Systematic therapeutic drug monitoring|Blood samples with antiepileptic drug level measurement
16019877|NCT02739269|Other|Serum AMH measurement|Serum AMH is measured one month before the IVF treatment
16019878|NCT02739269|Other|AFC measurement|Early follicular phase AFC is measured one month before the IVF treatment
16019879|NCT02739256|Procedure|Retrograde voiding trial|A bladder test is performed after surgery for prolapse to make sure the patient can empty their bladder prior to discharge from the hospital. The test consists of filling the bladder with 300 mL of water and removing the catheter. Then the patient voids.
16019880|NCT02739243|Behavioral|Tailored group intervention (PREPARE)|
16019881|NCT02739243|Behavioral|Individual treatment as usual|
16019882|NCT02739230|Drug|Exparel|
16019883|NCT02739230|Drug|On-Q pain intra-articular catheter|
16019884|NCT02739217|Drug|PBI-4050|Four 200 mg capsules (800 mg total) administered orally, once daily.
16019885|NCT02739204|Drug|Celecoxib|200 mg of Celecoxib daily for 6-month treatment after surgery within 1 - 6 months
16019886|NCT02739191|Device|PICO, Smith & Nephew|Direct application of negative pressure wound therapy following Foot and Ankle surgery
16019887|NCT02739178|Other|GSF Intervention|Intervention utilizes community-based demand generation matched with supply side improvements to improve access and use of sanitation facilities in rural communities. This is complimented with multi-stakeholder engagement to promote cooperation and coordination with national, state, and local stakeholders.
16019888|NCT02739165|Drug|ART-123|380 U/kg/day by intravenous drip infusion in addition to standard of care steroid therapy
16019889|NCT02739165|Drug|Placebo|Placebo by intravenous drip infusion in addition to standard of care steroid therapy
16019890|NCT02739139|Dietary Supplement|AlphaBrain|Alpha BRAIN® (Onnit Labs LLC) is a multi-ingredient nutritional supplement that purports to enhance cognitive function in healthy adults. The commercially available product contains 12 naturally occurring compounds
16019891|NCT02739126|Procedure|Radial EBUS biopsy|Radial EBUS is an endobronchial USS which is used to obtain biopsies from a peripheral lung mass.
16019892|NCT02739126|Device|Types of Radial Ultrasound probes|The Radial USS probe comes in two sizes. A thick USS probe that is 1.7mm and the thin USS is 1.4mm in diameter.
16019893|NCT02739100|Drug|Triferic|
16019894|NCT02739087|Procedure|MRI guided cardiac catheterization|Magnetic resonance imaging will be used to guide cardiac catheterization procedures whenever possible to avoid or minimize x-ray radiation exposure.
16019895|NCT02739087|Device|Magnetic resonance imaging|
16019896|NCT02739061|Behavioral|cognitive behavioral group therapy|"Establish closed every collection of six or so patients structured group. Each group patients were treated for 12 times, once a week, 120 minutes at a time.
~Treatment for 1 to 3 times to obsessive-compulsive disorder and cognitive behavioral therapy as the theme of psychological education; 4 to 6, 8 to 10 times exposed step by step and reaction treatment and prevention of training;7 and 11 times invite patients family members or other caregivers, make education about obsessive-compulsive disorder cognitive behavioural therapy, to promote patients exposed response prevention homework completion and social support; The 12th time treatment is self assessment and treatment guidelines for a long time."
16019897|NCT02739061|Drug|sertraline, fluvoxamine|Select specified drugs (sertraline, fluvoxamine)
16019898|NCT02739061|Other|cognitive behavioral group therapy and drug therapy|Select specified drugs (sertraline, fluvoxamine) and start group cognitive behavior therapy for 12 weeks at the same time
16019899|NCT02739035|Drug|Dexamethasone|8 mg of IV dexamethasone immediately before MUA.
16019900|NCT02739035|Drug|Celecoxib|2 weeks per mouth of celecoxib (200 mg daily)
16019901|NCT02739022|Behavioral|Early Psychological Support for the Critically Ill (EPSCI)|early psychological support based on positive therapeutic suggestion
16019902|NCT02739009|Drug|MOR106 single ascending doses, intravenous|
16019903|NCT02739009|Drug|Placebo single ascending doses, intravenous|
16019904|NCT02739009|Drug|MOR106 multiple ascending doses, intravenous|
16019905|NCT02739009|Drug|Placebo multiple intravenous administrations|
16019906|NCT02738996|Behavioral|Sedentary time breaks either every 60 minutes|Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 60 min
16019907|NCT02738996|Behavioral|Sedentary time breaks either every 30 minutes|Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 30 min
16019908|NCT02738996|Behavioral|Sedentary time breaks every 15 minutes|Sitting for 8 hours interrupted by 3 min of light intensity walking (LIW, 3.2 km/h) breaks every 15 min
16019909|NCT02738983|Drug|Erlotinib (trade name: Tarceva®) or Icotinib (trade name: Conmana®)|Erlotinib (trade name: Tarceva®) (150mg oral daily) or Icotinib (trade name: Conmana®) (125mg oral three times a day).
16019910|NCT02738983|Radiation|Radiotherapy|Concurrent radiotherapy total dose 60-66 Gy in 2 Gy fractions. One fraction per day, and 5 fractions per week.
16019911|NCT02738970|Drug|Trastuzumab|Participants will receive a single dose of trastuzumab 600 mg SC separately, co-mixed or co-formulated with pertuzumab.
16019912|NCT02738970|Drug|Pertuzumab|Participants will receive pertuzumab as a single agent injection, co-mixed or formulated as FDC with trastuzumab depending upon cohort. The dose will range from 400 to 1200 mg.
16019913|NCT02738957|Behavioral|Prenatal Counseling Group|"Specific counseling on breastfeeding consisting of three different counseling sessions during prenatal visits given by one of the two midwives involved in the study. The information provided include the following: breastfeeding importance; how to prepare the nipples and breast for breastfeeding; the main complications and difficulties during the breastfeeding process and how to identify and overcome them; breastfeeding techniques and alternative positions for the simultaneous breastfeeding of twins, for example, double cradle, cradle-football or double-football, using illustrations and hands-on demonstration with doll models."
16019914|NCT02738944|Behavioral|Telepsychiatry Collaborative Care|The telepsychiatrist will also conduct an initial consultation with the patient via interactive video to establish the diagnosis and recommend medications to prescribe. Onsite primary care providers prescribe psychotropic medications. Onsite care managers work with patients either face-to-face or by phone to promote adherence to treatment and assess treatment response. Care managers provide Behavioral Activation either face-to-face or by phone. Care managers have weekly provider-to-provider consultations with the telepsychiatrist to review treatment plans for patients not responding to treatment. The telepsychiatrist will make revised treatment recommendations to the primary care provider.
16019948|NCT02738671|Behavioral|Cognitive assessment|
16019949|NCT02738671|Other|functional magnetic resonance imaging|
16019950|NCT02738671|Other|olfactory function measurement|
16019951|NCT02738671|Procedure|bariatric surgery|Only a subgroup of the subjects will have the bariatric surgery.
16019952|NCT02738658|Device|Bioresorbable vascular scaffold|
16019953|NCT02738658|Device|Everolimus-eluting stent|
16019954|NCT02738645|Other|pneumonia|
16020113|NCT02737475|Drug|Ipilimumab|Specified dose on specified days
16019915|NCT02738944|Behavioral|Telepsychiatry Enhanced Referral|"The offsite telepsychiatrist and/or telepsychologist delivers the treatment via interactive video to patients located at primary care clinics. Telepsychiatrists/telepsychologists administer symptom rating scales at each session. The first encounter will be with the telepsychiatrist to establish diagnosis and develop a treatment plan consisting of algorithm-informed medication management and/or evidence-based psychotherapy. The telepsychiatrists will prescribe medications. Psychotherapy options include Cognitive Processing Therapy and Cognitive Behavioral Therapy.
~If a patient does not engage in treatment (<=2 encounters) in the first six months, they will be randomized a second time to continued Telepsychiatry Enhanced Referral or Telephone Enhanced Referral for the second six months. Phone Enhanced Referral involves delivering psychiatric and/or psychological treatment (either initially or exclusively) by telephone to patients in their home."
16019916|NCT02738931|Drug|Dolutegravir 50 mg tablet|A white, film-coated, round tablet debossed with SV 572 on one side and 50 on the other side. Single dose of one tablet will be administered with 240 mL of water.
16019917|NCT02738931|Drug|Lamivudine 300 mg tablet|"Gray, diamond-shaped tablet, engraved GX EJ7 on one side and plain on the other side. Single dose of one tablet will be administered with 240 mL of water."
16019918|NCT02738931|Drug|Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AA)|Immediate release oval tablet embossed 'gsk' on one face with white film coat. Single dose of one tablet will be administered with 240 mL of water.
16019919|NCT02738931|Drug|Dolutegravir/Lamivudine 50 mg/300 mg Tablet (Product Code AB)|Immediate release oval tablet embossed 'gsk' on one face with white film coat. Single dose of one tablet will be administered with 240 mL of water.
16019920|NCT02738918|Drug|Nulojix (Belatacept)|Nulojix Administration will start the day of transplantation (day 1 and first dosing day);10 mg/kg : (day1, 5,14,28 ), Week 8 and 12 and then 5 mg/kg every 4 weeks until Month 12
16019921|NCT02738905|Drug|Rifaximin|One 550 mg tablet taken orally two times a day.
16019922|NCT02738879|Drug|Sitagliptin|Sitagliptin 100 mg, oral, once daily for 30 weeks
16019923|NCT02738879|Drug|Placebo to sitagliptin|Placebo to sitagliptin, 100 mg, oral, once daily for 30 weeks
16019924|NCT02738879|Drug|Metformin|At least 1500 mg/day, oral, twice daily for participants entering the study on immediate-release metformin + sitagliptin or a fixed dose combination (FDC).
16019925|NCT02738879|Drug|Metformin XR|At least 1500 mg/day, oral, once daily for participants entering the study on extended-release metformin + sitagliptin or a FDC.
16019926|NCT02738879|Drug|Insulin glargine|Insulin glargine (LANTUS®) initiated at 10 units and titrated based on a treat-to-target algorithm to achieve fasting glucose levels of 72-100 mg/dL (4-5.6 mmol/L); administered once daily subcutaneously.
16019927|NCT02738866|Drug|Palbociclib|Palbociclib will be given orally, continued at the same dose as was received previously; the maximum starting dose will be per the approved label, a dose of 125 mg once daily. Palbociclib will be taken days 1-21, then seven days off treatment to complete one 28 day cycle.
16019928|NCT02738866|Drug|Fulvestrant|Fulvestrant 500 mg should be administered intramuscularly into the buttocks slowly (1-2 minutes per injection) as two 5 mL injections, one in each buttock, on days 1, 15, and 29 (i.e., Cycle 2 Day 1) and once monthly thereafter (i.e., day 1 of each cycle).
16019929|NCT02738853|Device|Medtronic Transcatheter Aortic Valve 2.0 Replacement System|Treatment of severe symptomatic aortic stenosis in subjects who are considered at high through extreme risk for surgical aortic valve replacement.
16019930|NCT02738840|Procedure|MRI scan|MRI scan
16019931|NCT02738827|Procedure|Laser treatment|Intervention is diode laser treatment of bladder cancer through a cystoscope in the outpatient department
16019932|NCT02738814|Drug|propofol|When severe emergence agitation(PAED > 13) is occurred, Pharmacologic treatment of emergence agitation relies on the administration of IV propofol 0.8 or 1 mg/kg.
16019933|NCT02738801|Drug|GLPG1690 600 mg QD|GLPG1690 capsules, administered at a dose of 600 mg, orally QD
16019934|NCT02738801|Drug|Placebo QD|Matching placebo capsules, administered orally QD
16019935|NCT02738788|Other|Intubation|"The patient's airway will be visually assessed and photographed while the patient is resting comfortable in bed with the head up at 30-45 degrees and classified into one of 4 MMS categories. Digital photographs will be taken and the stored image prepared by the investigators in such a way that the patient cannot be individually identified (mouth only).
~Neck circumference will be measured at the level of the thyroid cartilage using a tape measure, with temporary ink marks on the skin to allow for subsequent measurements at the same point.
~After the patient has been extubated and recovered in the PACU for 30 minutes, their airway will be re-assessed and documented. These evaluations will be repeated at 2, 3, and 4 hours, as well as the next morning."
16019936|NCT02738775|Biological|Ublituximab|Administered as an IV infusion.
16019937|NCT02738775|Drug|Placebo|
16019938|NCT02738762|Other|glutamine supplementation|glutamine supplementation guided by glutamine levels in plasma
16019939|NCT02738749|Device|Implantable cardioverter-defibrillator (ICD)|Patients with newly implanted implantable cardioverter-defibrillators (ICDs) for primary prevention will be enrolled.
16019940|NCT02738736|Behavioral|Sodium Reduction|In addition to usual care, those randomised to the intervention arm will receive specific counseling on behavioural and environmental factors that promote sodium reduction after randomization and at all specified post-randomisation visits, targeting sodium intake of <100mmol/day (<2.3g/day). A research dietitian will develop the specific components of the intervention, based on standardised approaches to education interventions
16019941|NCT02738723|Radiation|SBRT|40 Gy for each patient. Patients receiving once-daily therapy ,4 Gy daily in 10 treatments over a period of two weeks.
16019942|NCT02738723|Radiation|IMRT|45 Gy for each patient，Accelerated twice-daily thoracic radiotherapy involved the administration of 1.5 Gy in 30 treatments over a period of three weeks.
16019943|NCT02738723|Drug|EP|Etoposide 75mg/m2/iv over 90min through day 1 to day 4 and cisplatin 25mg/m2/iv over 30min through day 1 to day 3, repeat Q 3weeks. Continuous administration to six cycles or to disease progression, unacceptable toxicity or patients' refusal.
16019944|NCT02738710|Procedure|transumbilical incision|incision within umbilicus
16019945|NCT02738710|Procedure|Infra umbilical incision|incision about 1 cm below umbilicus
16019946|NCT02738697|Drug|Adjuvant chemotherapy|8~12 cycles of adjuvant chemotherapy with FOLFOX were performed 4-6 weeks after radical surgery
16019947|NCT02738697|Procedure|Follow-up|Patients received just follow-up instead of adjuvant chemotherapy
16019955|NCT02738632|Drug|Telmisartan/Amlodipine+Hydrochlorothiazide|"Treatment1:Telmisartan/Amlodipine 40/5mg 1 Tab.and Hydrochlorothiazide 12.5mg 1 Tab.QD
~Treatment2: Telmisartan/Amlodipine 40/5mg 2 Tab.and Hydrochlorothiazide 25mg 1 Tab.QD"
16019956|NCT02738632|Drug|Telmisartan/Amlodipine|"Treatment1:Telmisartan/Amlodipine 40/5mg 1 Tab.and Hydrochlorothiazide 12.5mg Placebo 1 Tab.QD
~Treatment2: Telmisartan/Amlodipine 40/5mg 2 Tab.and Hydrochlorothiazide 25mg Placebo 1 Tab.QD"
16019957|NCT02738632|Drug|Placebo for Hydrochlorothiazide|
16019958|NCT02738619|Drug|Vitamin D3|1600 UI
16019959|NCT02738619|Drug|placebo|placebo
16019960|NCT02738606|Drug|Chemotherapy|
16019961|NCT02738606|Other|Laboratory Biomarker Analysis|Correlative studies
16019962|NCT02738606|Procedure|Metastasectomy|Undergo lung metastasectomy
16019963|NCT02738606|Other|Quality-of-Life Assessment|Ancillary studies
16019964|NCT02738606|Procedure|Therapeutic Conventional Surgery|Undergo hepatectomy
16019965|NCT02738580|Drug|COS with GnRH antagonists and rFSH|Controlled ovarian hyperstimulation with GnRH antagonists and rFSH in women with normal ovarian function.
16019966|NCT02738580|Drug|COS with GnRH antagonists and HP-HMG|Controlled ovarian hyperstimulation with GnRH antagonists and HP-HMG in women with normal ovarian function.
16019967|NCT02738567|Procedure|patients undergoing surgery or medical procedure|
16019968|NCT02738554|Other|Treatment cessation|Cessation of nucleoside analogue therapy following European Association for the Study of the Liver guidelines
16019969|NCT02738541|Drug|DENTRIFICE CONTAINING 5% SODIUM AND POTASSIUM PYROPHOSPHATE|DENTRIFICE CONTAINING 5% SODIUM AND POTASSIUM PYROPHOSPHATE WAS ADVISED TWICE DAILY FOR 6 MONTHS
16019970|NCT02738541|Drug|PLACEBO DENTRIFICE WITHOUT PROPHOSPHATE|PLACEBO DENTRIFICE WITHOUT PYROPHOSPHATE WAS ADVISED TWICE DAILY FOR 6 MONTHS
16019971|NCT02738528|Other|Mental practice and brushing guidance in patients with Parkinson Disease|
16019972|NCT02738515|Drug|0.75 % Boric Acid|After Scaling and Root Planing placement of 0.75% Boric Acid gel in Mandibular degree 2 Furcation defect.
16019973|NCT02738515|Drug|placebo|After Scaling and Root Planing placement of Placebo gel in Mandibular degree 2 Furcation defect.
16019974|NCT02738502|Drug|darunavir monotherapy|darunavir 600 mg + ritonavir 100 mg 2 times 24 (DRV/r) monotherapy started after checking the tolerance of DRV/r600 mg/100 mg twice daily to replace whatever prior ARVs were used, while maintaining the NRTI backbone for 2 weeks.
16019975|NCT02738489|Biological|SHR-1210|A fully human monoclonal immunoglobulin (IgG4 subtype)
16019976|NCT02738476|Procedure|Patellofemoral arthroplasty|
16019977|NCT02738450|Biological|ACI-24 low dose|ACI-24 administered as a sterile suspension in PBS via s.c. injection.
16019978|NCT02738450|Biological|ACI-24 high dose|ACI-24 administered as a sterile suspension in PBS via s.c. injection.
16019979|NCT02738450|Biological|Placebo|Placebo is a standard PBS sterile solution administrated via s.c. injection.
16019980|NCT02738437|Device|Kryptonite-bone cement|
16019981|NCT02738424|Other|Calculate the ADC scores|The MRI will be performed on the two groups of patients in the usual care. The intervention will be based on the ADC scores calculation. The scores will be obtained with three types of post-processing softwares : Siemens, PACS Carestream, Osirix.
16019983|NCT02738385|Behavioral|High Intensity Interval Training|Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
16019984|NCT02738385|Behavioral|Moderate Intensity Interval Training|Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
16019985|NCT02738372|Other|Diagnosis/Prognosis|The present study will be a 24 months multi-center, triple-blind, prospective, cohort study which will be carried out between April 2016 and March 2018. Subjects diagnosed of rotator cuff (RC) tendinopathy, adhesive capsulitis (AC), glenohumeral instability, SLAP lesion, and/or acromioclavicular pathology and fulfill the inclusion criteria will be asked for participating in our study. Several questionnaires that will test the influence of different biopsychosocial factors and the presence of Central Sensitization will be administrated to these subjects. The outcomes will be assessed at baseline and 5 follow-ups (after 3, 6, 12, 18 and 24 months, t1-t6).
16019986|NCT02738359|Procedure|optical colonoscopy|optical colonoscopy
16019987|NCT02738359|Procedure|colon capsule endoscopy|colon capsule endoscopy
16019988|NCT02738359|Diagnostic Test|fecal immunological test (FIT)|fecal immunological test (FIT)
16019989|NCT02738346|Drug|Carboplatin|Intravenous administration of Carboplatin AUC 5 at Day 1, Every 3 weeks, maximum 6 cycles
16019990|NCT02738346|Drug|Etoposide|Intravenous administration of 100mg/m²/day of Etoposide, Day 1 to Day 3 Every 3 weeks, maximum 6 cycles
16019991|NCT02738346|Drug|Topotecan|Per os administration of 2.3 mg / m2 of Topotecan, Day 1 to Day 5 Every 3 weeks, maximum 6 cycles
16019992|NCT02738346|Device|CT scans|The CT scan evaluations will be conducted during chemotherapy every 6 weeks
16019993|NCT02738333|Drug|LDV/SOF|90/400 mg FDC tablet administered orally once daily
16019994|NCT02738333|Drug|SOF|400 mg tablet administered orally once daily
16019995|NCT02738333|Drug|RBV|Capsules administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, > 60 kg to ≤ 80 kg = 800 mg, and > 80 kg = 1000 mg)
16019996|NCT02738320|Other|NHCPlus|A decision-aid tool that will interface with Nursing Home Compare and improve consumers' ability to assimilate and incorporate the information into their process of choosing a nursing home.
16019997|NCT02738307|Other|Altitude exposure|Acute high altitude exposure followed by 8 day acclimatization and re-exposure for 8 days after 6 days at low altitude
16019998|NCT02738294|Device|ME-NBI observation and ME-NBI targeted biopsy|The endoscopist assessed lesions which were suspected EGC carefully with ME-NBI. After assessing suspected EGC in ME-NBI view, ME-NBI targeted biopsy was performed where abnormal phenomenon was identified in ME-NBI view.
16019999|NCT02738268|Device|Low-level laser therapy|Low-Level Laser Therapy will be applied, twice a week, from the start of radiotherapy treatment in combination with the standard skin care.
16020000|NCT02738268|Device|sham laser|
16020001|NCT02738255|Device|Varnum mouthpiece|
16020081|NCT02737670|Drug|Placebo|1 tablet morning and evening for 40 days
16020082|NCT02737644|Other|observation|This is an observational study
16020002|NCT02738242|Device|Novus system|The Novus system is a FES based neuroprosthesis, which intended to provide ankle dorsiflexion and knee flexion or extension in individuals with foot drop and thigh muscle weakness, following an upper motor neuron injury or disease.
16020003|NCT02738229|Drug|Valacyclovir|
16020004|NCT02738229|Drug|placebo|
16020005|NCT02738216|Behavioral|Prenatal Yoga|As part of the yoga program, participants will be asked to go to one 75-minute prenatal yoga class each week for 9 weeks. The yoga classes will be designed to be safe for pregnant women. In addition to classes, the yoga teacher will ask them to practice yoga at home during the program. Each participant will be given a yoga mat and a prenatal yoga DVD to take home.
16020006|NCT02738216|Behavioral|Mother Baby Wellness|This workshop is aimed at promoting moms' and babies' good health and will involve attending one 75-minute class each week for 9 weeks. Classes will cover topics such as: child development in the first year, child eating and sleeping in the first year, maintaining good health as a mom of an infant, and recent advances in women's healthcare. In addition to classes, participants will be given materials to review/ read at home.
16020007|NCT02738203|Drug|Vaginal 2% Lidocaine|Patient-administered vaginal Lidocaine jelly verse surgical lubricant jelly
16020008|NCT02738203|Drug|Surgical Lubricant Jelly|Patient-administered vaginal surgical lubricant jelly verse Lidocaine jelly
16020009|NCT02738190|Drug|Albumin|Albumin 5% added to blood priming solution
16020010|NCT02738190|Biological|Fresh Frozen Plasma|Fresh Frozen Plasma added to blood priming solution
16020011|NCT02738177|Drug|Misoprostol|2 tablets of misoprostol (i.e. 400 ug) 4 hrs prior to surgical evacuation high up in the posterior fornix (misoprostol group)
16020012|NCT02738177|Drug|Isosorbide-5-mononitrate|2 tablets of Effox (i.e. 40 mg) 4 hrs prior to surgical evacuation high up in the posterior fornix (effox group)
16020013|NCT02738177|Drug|misoprostol and Isosorbide-5-mononitrate|1tablets of misoprostol (i.e.200 ug) & 1 tablets of Effox (i.e. 20 mg) 4 hrs prior to surgical evacuation high up in the posterior fornix (combination therapy group)
16020014|NCT02738151|Drug|Insulin glargine, 300U/mL|Self-administered by subcutaneous (SC) injection in the evening using a pre-filled pen. Dose titration to achieve fasting self-monitored plasma glucose (SMPG) from 80 to 100 mg/dL (4.4 to 5.6 mmol/L).
16020015|NCT02738151|Drug|Insulin degludec, 100 U/mL|"Self-administered by subcutaneous (SC) injection in the evening using a pre-filled pen. Dose titration to achieve fasting self-monitored plasma glucose (SMPG) from 80 to 100 mg/dL (4.4 to 5.6 mmol/L).
~Route of administration: subcutaneous"
16020016|NCT02738151|Drug|Non-insulin anti-diabetic treatment|Background therapy: Oral Anti diabetics Drugs (OADs), Glucagon-like peptide-1 (GLP-1) receptor agonist.
16020017|NCT02738138|Drug|ABT-493 coformulated with ABT-530|Tablet
16020018|NCT02738112|Device|Encore System|Hyo-mandibular suspension
16020019|NCT02738086|Behavioral|Physical Activity Behavior Change (PABC)|Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning.
16020020|NCT02738086|Behavioral|Physical Activity Behavior Change (PABC)|Home-based weekly sessions (30 min) using behavior change methods for promoting physical activity. Sessions will occur using home-based computer tablets for real-time video interface between the participant and therapist. Participants will wear wrist-mounted activity sensors with direct physical activity feedback during the intervention period to allow for behavioral feedback and action planning
16020021|NCT02738073|Drug|Control: Saline|
16020022|NCT02738073|Drug|Tranexamic Acid|
16020023|NCT02738060|Dietary Supplement|Baked Milk|"The patients in case group will be received baked milk daily in the form of muffin(30 cc milk (equal to 1/3 of milk's proteins) heated in 350 F or 180 C for 30 mints) for 6 months. They will be visited weekly in the first month and every 2 weeks in other 5 months. At the end of the 6 months, the patients will undergo oral food challenge by 30 grams baked cheese in the form of pizza cheese. If the test will be negative, they will receive pizza cheese 4 or 7 days per week for other 6 months. The patients will be followed every 2 weeks during this period.
~Skin prick test and serum IgE levels will be done at the beginning of the study, at 6 and 12 months. IgG4, being specific for milk allergens, will also measured at the beginning and at 12 months of the study."
16020024|NCT02738034|Other|Cogmed|The Cogmed is computer software designed to train visuospatial and audio-verbal working memory, and other functions associated with working memory: attention, focus and impulsiveness. It has three versions adapted to different age groups: Cogmed for younger children, about 4-7 years, which are not yet so familiar with numbers and letters; Cogmed for children over 7 years and adolescents; and Cogmed for youth and adults over 18 years. In this study we will use the version for youth and adults over 18 years.
16020025|NCT02738021|Behavioral|STRONG|A brief 3-session IPT-based preventive intervention, on maternal and child health outcomes.
16020026|NCT02738008|Drug|ARC-520 Injection|IV injection
16020027|NCT02738008|Drug|entecavir|All participants will take entecavir or tenofovir throughout the study. Participants will be instructed to take their medication daily.
16020028|NCT02738008|Drug|tenofovir|All participants will take entecavir or tenofovir throughout the study. Participants will be instructed to take their medication daily.
16020029|NCT02738008|Drug|antihistamine|All participants will be pretreated with an oral antihistamine. The antihistamine used should in general be an H1>H2 receptor blocker and would include diphenhydramine 50 mg, cetirizine 10 mg, chlorpheniramine 8 mg or hydroxyzine 50 mg. The Investigator is free to choose any of these antihistamines available locally and consistent with their country's Marketing Authorisation.
16020030|NCT02737995|Drug|Ferric carboxymaltose infusion|Subjects with functional iron deficiency determined by the results of iron biomarker results at Visit 2 will receive a single dose of intravenous ferric carboxymaltose . The dose of Injectafer will be calculated from a modified Ganzoni equation adapted from previous heart failure clinical trials The maximum dose of Injectafer will be 750 mg. The calculated dose of Injectafer will be diluted in normal saline solution (4 mg/ml) and administered via a volumetric pump administered over 30 minutes.
16020031|NCT02737982|Procedure|percutaneous coronary intervention|coronary angiography with or without stent implantation, measurement of indexes of epicardial and microvascular reperfusion
16020083|NCT02737631|Device|"Chameleon Personal Lubricant"|
16020032|NCT02737969|Device|Transesophageal Echocardiography/angiography (TEE/Angio)|"The TEE probe will be inserted into the patient's esophagus, after anesthetic induction or conscious sedation is administered, and removed after the completion of the procedure. Once the TEE probe is placed, the interventional cardiologist will acquire 2 fluoroscopic images with the TEE probe. These images will be used to co-register the ultrasound and fluoroscopy systems. As part of routine care, TEE and fluoroscopy images will be acquired throughout the procedure for clinical purposes. As new fluoroscopy images are acquired, the prototype software will automatically track the location of the TEE probe. When the echocardiographer has an image of a cardiac structure of interest, he may use the prototype software to place landmarks.
~The echocardiographer may then press a button to have the landmarks displayed on the fluoroscopy image that is only visible on an assist monitor and will not interfere with the standard fluoroscopy imaging monitor."
16020033|NCT02737943|Drug|Moist Exposed Burn Ointment (MEBO)|is a registered USA patented formulation since 1995. MEBO is pure herbal, natural in origin, containing beta-sitosterol phellodendron amurense, scutellaria baicalensis, coptis chinensis, pheretima aspergillum, Beeswax and sesame oil. 15, 19 The pharmacological effects are attributable to: beta-sitosterol, isolated from phellodendron amurense, flavonoids mainly baicalin isolated from scutellaria baicalensis, alkaloids mainly berberine, isolated from coptis chinensis, Beeswax and sesame oil.
16020034|NCT02737943|Drug|Zagazig|Standard care is an antibiotic ointment in combination of analgesic for relief of pain.
16020035|NCT02737930|Drug|Fluoxetine|
16020036|NCT02737930|Drug|Placebo|
16020037|NCT02737917|Other|Oxygen|15 L of oxygen will be delivered to the patient by nasal cannula during the apnea period of rapid sequence intubation.
16020038|NCT02737917|Other|Standard of care|Rapid sequence intubation
16020039|NCT02737904|Other|APT|APT for 30 minutes per day on 5 days per week for 4 weeks: 2 minute warm up consisting of passive cycling, where the legs of the participant are moved passively by the APT at 10 revolutions per min (rpm). Next, the participant will cycle for up to 26 minutes, at 60rpm. In this phase, the participant is required to actively cycle and to maintain a symmetrical pattern of movement using the feedback on the display. If the participant is unable to actively cycle at any point during the 26 minute exercise period, or if they have a spasm, the MOTOmed APT will revert to the passive mode. The final phase is a cool down where participants again will have 2 minutes of passive cycling at 10rpm.
16020040|NCT02737904|Other|Usual care|Personalised in-patient rehabilitation programme
16020041|NCT02737891|Drug|Tesofensine/Metoprolol|Tesofensine 0.5 mg + Metoprolol 100 mg
16020042|NCT02737891|Drug|Placebo|
16020043|NCT02737878|Behavioral|Aerobic Training|"Six months of twice-weekly aerobic training that will gradually progress in intensity. Each training session will be 60 minutes (10 minutes of warm-up, 40 minutes of training, and 10 minutes of cool-down).
~To meet the public health mandates of COVID-19, when it is necessary, training will occur at home, with the use of wearables to monitor heart rate. Participants will be provided access to instructional videos either by YouTube or DVD. They will be called on a weekly basis to monitor progress and compliance."
16020044|NCT02737878|Behavioral|Resistance Training|"Six months of twice-weekly resistance training program that will gradually progress in intensity. Each training session will be 60 minutes (10 minutes of warm-up, 40 minutes of training, and 10 minutes of cool-down).
~To meet the public health mandates of COVID-19, when it is necessary, training will occur at home, with the use of a set of resistance bands of various weights. Participants will be provided access to instructional videos either by YouTube or DVD. They will be called on a weekly basis to monitor progress and compliance."
16020045|NCT02737878|Behavioral|Balance and Tone Training|"Six months of twice-weekly stretching and relaxation program that includes stretches, deep breathing and relaxation techniques, general core control exercises, and general posture and health education. Each session will be 60 minutes.
~To meet the public health mandates of COVID-19, when it is necessary, training will occur at home, with the use of small equipment (e.g., pilate ball). Participants will be provided access to instructional videos either by YouTube or DVD. They will be called on a weekly basis to monitor progress and compliance."
16020046|NCT02737878|Behavioral|Balance and Tone Training|"Six months of twice-weekly stretching and relaxation program that includes stretches, deep breathing and relaxation techniques, general core control exercises, and general posture and health education. Each session will be 60 minutes.
~To meet the public health mandates of COVID-19, when it is necessary, training will occur at home, with the use of small equipment (e.g., pilate ball). Participants will be provided access to instructional videos either by YouTube or DVD. They will be called on a weekly basis to monitor progress and compliance."
16020047|NCT02737865|Drug|Sonazoid|Sonazoid: Commercially available contrast material for ultrasonography
16020048|NCT02737865|Device|Superb-Microvascular imaging|Superb-Microvascular imaging: new sonographic software technique on ultrasonography to detect low-vascular flow without use of contrast media for ultrasonography
16020049|NCT02737852|Device|"Trojan Chameleon Personal Lubricant"|silicone base with sensate
16020050|NCT02737839|Other|Stepping On Education Program|
16020051|NCT02737839|Other|Home visit|
16020052|NCT02737839|Other|Patient Questionnaire|-Includes questions about demographics, activity level, performance status, falls, medication, comorbidities, hearing, vision, pain, and neuropathy
16020053|NCT02737839|Other|Mini-Balance Evaluation Systems Test|"The Mini-BESTest includes 14-items that assess balance across four domains: 1) anticipatory postural adjustments, 2) reactive postural responses, 3) sensory orientation, and 4) stability in gait. Each item is rated on a 0-2 scale with 0 indicating poor balance and 2 indicating no impairment. The total possible score on the Mini-BESTest is 28 points
~Balance testing will take approximately 15 minutes."
16020054|NCT02737839|Other|GAITRite|"Gait will be assessed using the 4.87-m GAITRite
~The GAITRite is a computerized mat that allows for measurement of spatiotemporal measures (e.g., gait velocity, stride length) of gait. We will measure gait in the following conditions: 1) comfortable forward, 2) fast-as-possible, and 3) dual-task. For comfortable forward, participants will be asked to walk at their self-perceived normal pace. For fast-as-possible, participants will be asked to walk as quickly and safely as possible. For dual-task, participants will be asked to walk at their comfortable pace forward while saying as many words that begin with a letter given to them just prior to the start of the trial. Participants will complete five trials of each condition. Gait testing will take approximately 15 minutes."
16020084|NCT02737618|Device|"Trojan Chameleon Personal Lubricant"|silicone base with sensate
16089250|NCT02242318|Drug|Valsartan|
16020055|NCT02737839|Other|Precise measure of movement testing|We will conduct additional movement-based testing with participants wearing small, portable sensors (APDM, Inc., Portland, OR). These sensors allow for precise measurement of movement characteristics. The sensors will be worn on the outside of clothing and will be placed on the following body locations: 1) sternum, 2) low back, 3) right wrist, 4) left wrist, 5) right ankle, and 6) left ankle. The participants will wear these sensors during the following movement tasks: 1) Two Minute Walk Test, 2) Timed Up & Go, 3) Dual Timed Up & Go, 4) Stand and Walk (SAW), and 5) 360 Degree Turn test. These sensors will allow for capture of precise measures postural sway, arm swing, gait variability, and many other variables the proposed movement tasks.
16020056|NCT02737826|Drug|Buprenorphine Initiation - Phase I|In Phase I, we will determine buprenorphine tolerability using a one-day outpatient buprenorphine initiation protocol up to 16mg sublingually over an 8 hour induction window.
16020057|NCT02737826|Drug|Gabapentin + Buprenorphine - Phase II|Subjects who tolerate sublingual buprenorphine initiation in Phase I will proceed to Phase II, which will involve randomization to oral gabapentin or placebo, 2 week stabilization period, and up to 8 week buprenorphine tapering period. Those randomized to gabapentin will receive up to 1600mg gabapentin (double blinded) divided three times daily, titrated over the 2 week stabilization period and continued during the buprenorphine tapering period. During the 2 week stabilization period, buprenorphine will also be titrated up to 24mg as needed/tolerated.
16020058|NCT02737826|Drug|Placebo + Buprenorphine - Phase II|Subjects who tolerate sublingual buprenorphine initiation in Phase I will proceed to Phase II, which will involve randomization to oral gabapentin or placebo, 2 week stabilization period, and up to 8 week buprenorphine tapering period. Those randomized to placebo will receive up to 1600mg placebo (double blinded) divided three times daily, titrated over the 2 week stabilization period and continued during the buprenorphine tapering period. During the 2 week stabilization period, buprenorphine will also be titrated up to 24mg as needed/tolerated.
16020059|NCT02737826|Drug|Buprenorphine taper - Phase II|After a 2 week stabilization period where sublingual buprenorphine is titrated up to 24 mg/day and oral gabapentin/placebo is titrated up to 1600mg/day, subjects will enter a buprenorphine tapering period lasting up to 8 weeks. The suggested buprenorphine taper will be determined by stabilizing dose, but able to be altered by prescriber or participant based on symptoms.
16020060|NCT02737813|Drug|Isobaric marcaine|Isobaric marcaine 2.2 mL for spinal block
16020061|NCT02737813|Drug|Hyperbaric marcaine|Hyperbaric marcaine 2.2 mL for spinal block
16020062|NCT02737800|Procedure|endometrioma aspiration|Transvaginal ultrasound guided aspiration
16020063|NCT02737800|Drug|GnRh agonist ( Decapeptyl )|3 monthly doses of Decapeptyl 7.5mg intramuscular
16020064|NCT02737800|Procedure|standard long stimulation protocol|Decapeptyl 3.75mg in the mid luteal phase followed by human menopausal gonadotropins(HMG);fostimon, or merional injections after bleeding, doses are individualization according to each patient, monitored by follicular size &serum estradiol.
16020065|NCT02737787|Biological|WT1 Vaccine|
16020066|NCT02737787|Drug|Nivolumab|Nivolumab will be administered intravenously as a 30-minute infusion per institutional guidelines on weeks 0, 2, 4, 6, 8, 10 and 12.
16020067|NCT02737787|Biological|NY-ESO-1 Vaccine|Patients will be vaccinated with the NY-ESO-1 OLP4 vaccine. Patients will receive a 1.0 mL emulsion of NY-ESO-1 OLPs with Poly-ICLC and Montanide.
16020068|NCT02737774|Drug|Icotinib|All cases that meet the criteria take Icotinib for 18 weeks, If there is no disease progression, then after 14 days of washout period, received 4 cycles of pemetrexed / carboplatin. After the chemotherapy, continue with Icotinib, 125mg Tid，PO. until disease progression.
16020069|NCT02737774|Drug|Pemetrexed/Carboplatin|All cases that meet the criteria take Icotinib for 18 weeks, If there is no disease progression, then after 14 days of washout period, received 4 cycles of pemetrexed / carboplatin (standard solution, 3 weeks for a cycle of chemotherapy : pemetrexed 500mg/m2 iv , 4 cycles. carboplatin AUC=5 iv ,4 cycles.). After the chemotherapy, continue with Icotinib, 125mg Tid，PO. until disease progression.
16020070|NCT02737761|Behavioral|Qualitative Interview and Adherence Measurements|Subjects will undergo an open-ended, semi-structured interview within two weeks of enrollment. The interview will be approximately 1 hour in length, performed by study staff who have been trained in qualitative research methods. This interview will be completed again 12 weeks later. Subjects will complete the MOS SAS, Automated Self-Administered 24-hour recall (ASA24), Life Orientation Test-Revised (LOT-R), Positive and Negative Affect Schedule (PANAS), Hospital Anxiety and Depression Scale (HADS), Kansas City Cardiomyopathy Questionnaire (KCCQ), and Medical Outcomes Study Short Form-12 (SF-12) at baseline and again at 12 weeks.
16020071|NCT02737748|Drug|TWB-103 add-on Tegaderm|TWB-103 is the primary therapeutics with the use of Tegaderm as a wound-site protection
16020072|NCT02737748|Drug|Placebo+Tegaderm|Placebo to TWB-103 with the use of Tegaderm as a wound-site protection
16020073|NCT02737735|Drug|standard chemotherapy medicine combined with Chinese herbs|
16020074|NCT02737735|Drug|standard chemotherapy medicine|
16020075|NCT02737722|Drug|Bisphosphocin Nu-3|
16020076|NCT02737722|Drug|Placebo|
16020077|NCT02737709|Drug|Paclitaxel and Carboplatin regimen|Chemotherapy regimen:Paclitaxel: 175mg/m2, d1; Intravenous drip injection with 500ml N.S；Carboplatin: AUC=5, d1; Intravenous drip injection with 500ml G.S Paclitaxel injection at first, followed with Carboplatin injection.
16020078|NCT02737696|Behavioral|Web-based prescription opioid prevention for adolescents|The intervention focuses on individual skills factors (e.g., promoting accurate knowledge about risks), as well as peer and societal influences on prescription opioid abuse (e.g., training skills to refuse offers to misuse opioids). When accessing the program, users see pictures of youth who have been in treatment for opioid dependence, and may choose to click on links to: 1) listen to or read real stories of problematic involvement with prescription opioids, 2) view youth' trajectories of important decision points related to prescription opioid misuse, 3) view videos that provide key information or teaches a skill that might help a young person make healthier choices (e.g., refusing offers to misuse prescription opioids), 4) or take quizzes to assess information/skill acquisition.
16020079|NCT02737696|Behavioral|JustThinkTwice.gov website (DEA)|The JustThinkTwice.com website is educational (a large percentage of the website content focuses on opioids) with a menu including: Drug Information, True Stories (of youth who have lost their lives to drugs), Consequences, Facts/Statistics, Videos (e.g., the Life of an Opiate Addict, and Synthetic Drugs), and a brief Quiz.
16020080|NCT02737670|Drug|Sulodexide|25 mg morning and evening for 40 days
16020085|NCT02737605|Drug|Intranasal Esketamine|Participants will receive 84 mg intranasal esketamine as 3 devices, each with 28 mg esketamine.
16020086|NCT02737605|Drug|Intravenous Esketamine|Participants will receive 0.8 milligram per kilogram body weight esketamine, 40 minutes, intravenous infusion.
16020087|NCT02737605|Drug|Moxifloxacin|Participants will receive 400 mg Moxifloxacin orally.
16020088|NCT02737605|Drug|Oral Placebo|Participants will receive matching placebo orally.
16020089|NCT02737605|Drug|Intravenous Placebo|Participants will receive placebo 40 minutes, intravenous infusion.
16020090|NCT02737605|Drug|Intranasal Placebo|Participants will receive intranasal placebo (1 spray in each nostril at 0, 5, and 10 minutes).
16020091|NCT02737592|Device|"Trojan Simply Pleasure Personal Lubricant"|silicone base without sensate
16020092|NCT02737579|Procedure|XFM guidance|X-ray images and MRI roadmaps are aligned, during the medically indicated catheterization procedure, both conventional X-ray and investigational XFM images are displayed side-by-side. The operator may choose to be guided by either.
16020093|NCT02737566|Behavioral|Standard Care + Financial Incentives|Tobacco cessation counseling plus pharmacotherapy and financial incentives for quitting.
16020094|NCT02737566|Other|Standard Care|Tobacco cessation counseling plus pharmacotherapy.
16020095|NCT02737553|Procedure|Enclosed morcellation|After extirpation of the myoma from the uterus and repair of the uterine defect, the myoma will be removed from the abdomen with an enclosed laparoscopic electromechanical morcellation as described in the literature by Akdemir et al with using surgical glove (Akdemir A et. al, Innovative technique for enclosed morcellation using a surgical glove. Obstet Gynecol. 2015 May;125(5):1145-9. doi: 10.1097/AOG.0000000000000823.).
16020096|NCT02737553|Procedure|vaginal morcellation|After extirpation of myoma from uterus and repair of the uterine defect, myoma will be removed through the vagina with posterior colpotomy. In this group myoma will also be removed in a enclosed fashion with using endo bag.
16020097|NCT02737527|Procedure|24G intravenous route for Lumbar Sympathetic Block (LSB):|Enrolled subjects enter the operative room with a 24G intravenous route, and then non-invasive blood pressure and pulse oxygen saturation level are continuously monitored during and after the procedure.
16020098|NCT02737527|Device|15-cm Chiba needle for Lumbar Sympathetic Block (LSB)|The skin entry point is infiltrated using 1% lidocaine. A curved 21 G, 15-cm Chiba needle (Cook Inc., Bloomington, IN, USA) is then advanced toward the anterolateral edge of target vertebral body by posterolateral approach in patients with prone position.
16020099|NCT02737527|Device|Ultrasound for Lumbar Sympathetic Block (LSB)|Using Ultrasound, the L3 is identified by locating the lumbosacral junction on a paramedian sagittal scan and then counting cranially. After marking the level of L3 vertebra, the modified transverse scan through lumbar intertransverse space (ITS) is obtained with the transducer positioned 4-6 cm lateral to the mid-line at the L2-L3 intervertebral level. The needle is inserted from a lateral to medial direction using in-plane technique. The needle tip is inserted towards the anterior fascia of the psoas major muscle as close as paravertebral space.
16020100|NCT02737527|Device|Fluoroscope for Lumbar Sympathetic Block (LSB)|Briefly, fluoroscopic guided LSBs are performed at the lower third of the L2 or the upper third of the L3 vertebra. A targeted lumbar vertebral is identified by AP fluoroscopic imaging and the fluoroscopic C-arm is adjusted 25-35° laterally to avoid the transverse process over the needle pathway. After the skin infiltration, the needle is advanced toward the anterolateral edge of the target lumbar vertebra under fluoroscopic guidance using the tunnel vision technique.
16020101|NCT02737527|Drug|10 ml of 0.25% levobupivacaine injection for LSB|After excluding vascular injection with contrast media by a C-arm image intensifier on anteroposterior (AP) and lateral view, 10 ml of 0.25% levobupivacaine is injected through the Chiba needle.
16020102|NCT02737527|Procedure|Temperature measurement for Lumbar Sympathetic Block (LSB)|Temperature monitoring and measurement: skin-surface temperatures are monitored with small, adhesive thermocouple probes attached bilaterally to the plantar surface of the feet using transparent patches at 1-min intervals for a maximum of 20 min.
16020103|NCT02737527|Procedure|Postprocedure care for LSB|Adverse events such as genitofemoral nerve block, lumbar plexus block (transient unilateral leg weakness), or others are documented during and after the procedure for 30 min.
16020104|NCT02737514|Procedure|Air insufflation|Insufflation during colonoscopy including insertion phase
16020105|NCT02737514|Procedure|water immersion|Water will infused during insertion phase and removed during withdrawal phase of colonoscopy
16020106|NCT02737514|Procedure|water exchange|Water will infused and removed during insertion phase of colonoscopy
16020107|NCT02737501|Drug|Brigatinib|Brigatinib tablets
16020108|NCT02737501|Drug|Crizotinib|Crizotinib tablets
16020109|NCT02737488|Behavioral|Trauma Systems Therapy (TST)|Treatment will be delivered by clinicians and trainees working at the CSC who have been trained in delivering TST. Participants who begin treatment in the safety-focused phase will have their treatment sessions in their homes. Whenever a child enters a different phase of treatment, he or she will go to the site for office visits. At the beginning of treatment, TST clinicians will do a brief diagnostic assessment. All documentation that is completed by the clinician as part of TST treatment at the NYU Langone Medical Center will be documented using Epic, a standard of care integrated health information system for patient safety. Although we are not providing the CSC's standard of care in this study,we are replicating standard care as TST is standard care in other settings. Providing medication is part of standard TST treatment and conforms to good usual practice integrated with psychotherapy. Medication will not be prescribed for research purposes.
16020110|NCT02737488|Behavioral|Treatment as Usual (TAU)|"Youth in the control group will be referred to a mental health clinic in close proximity to their residence, in order to receive an evaluation and trauma treatment as usually provided. It cannot be specifically determined, in advance, the nature of this treatment.
~The clinics will be contacted after the family enrolls to determine if there was a specific protocol followed. An NYU CSC research coordinator will contact the clinic and assist in scheduling the subject's first visit. Families who do not enroll in any community treatment or dropout of treatment will be followed according to the research protocol for data collection. At the 3, 6, and 9 month assessments, the research coordinator will request the patient's records from the community treatment clinic they are attending in order to track and keep record of the youth's treatment modality, progress, and visit frequency."
16020111|NCT02737475|Drug|BMS-986178|Specified dose on specified days
16020112|NCT02737475|Drug|Nivolumab|Specified dose on specified days
16020114|NCT02737475|Biological|Tetanus vaccine|Specified dose on specified days
16020115|NCT02737475|Biological|DPV-001 vaccine|DPV-001 (UbiLT3 and UbiLT6): Specified dose on specified days
16020116|NCT02737475|Drug|Cyclophosphamide|Specified dose on specified days
16020117|NCT02737462|Drug|CG200745 PPA|CG200745 PPA intravenously daily for first 5 consecutive days per cycle (4 weeks)
16020118|NCT02737436|Drug|Intranasal Oxytocin|Intranasal oxytocin (24IU) given 50 minutes prior to behavior assessment or scanning
16020119|NCT02737436|Drug|Placebo|Intranasal placebo spray given 50 minutes prior to behavior assessment or scanning
16020120|NCT02737423|Drug|cholecalciferol|Effect of Vitamin D on the symptoms of diabetic neuropathy
16020121|NCT02737410|Behavioral|Gut-directed Hypnotherapy|The GHT protocol used was the Manchester protocol of GHT and consisted of 10 weekly sessions (45 min), with six patients per group over a treatment period of 12 weeks. GHT was performed at the University Hospital by two experienced physicians trained in Manchester (UK).
16020122|NCT02737397|Drug|JMI-001 (SJP-304 and SJP-223)|
16020123|NCT02737397|Drug|SJP-304|
16020124|NCT02737397|Drug|SJP-223|
16020125|NCT02737397|Drug|placebo|
16020126|NCT02737384|Biological|Depletion in CD45RA graft donor|"Experimental treatment: negative fraction after CD34+ selection from PBSC graft is depleted of naïve CD45RA+ cells. this fraction is reinjected to the recipient and is the experimental product.
~Conditioning regimen:
~Up-front ATG from D-14 toD-11 Busulphan IV from D-8 to -5 Fludarabine from D-7 to D-4 Thiothepa D-3 to D-2
~Graft: CD34+ cells positively selected cells from PBSC of the donor
~Post transplant immunosuppression: ciclosporin started at D-1 to D+100"
16020127|NCT02737371|Drug|F901318 Dose level A oral|Adverse events days 1-10
16020128|NCT02737371|Drug|Placebo dose level A oral|Placebo adverse events days 1-10
16020129|NCT02737371|Drug|F901318 Dose level B oral|F901318 adverse events days 1-10
16020130|NCT02737371|Drug|Placebo dose level B oral|Placebo adverse events days 1-10
16020131|NCT02737371|Drug|F901318 Dose level C oral|F901318 adverse events days 1-10
16020132|NCT02737371|Drug|Placebo Dose level C oral|Placebo adverse events days 1-10
16020133|NCT02737358|Drug|N-acetylcysteine (NAC)|NAC or matched placebo will be given to study participants for 8 weeks.
16020134|NCT02737358|Other|Placebo|Matched placebo (2 capsules taken in the morning and evening) will be taken by study participants for eight weeks. All participants will receive brief smoking cessation counseling and support.
16020135|NCT02737345|Other|Rotem|
16020136|NCT02737332|Drug|Zytiga® (Abiraterone Acetate)|Zytiga® 1,000 mg (4 x 250 mg qd) tablets plus one 5 mg prednisone tablet to be taken bid, spaced approximately 12 hours apart
16020137|NCT02737332|Drug|SoluMatrix™ (Abiraterone Acetate)|SoluMatrix™ 500 mg (4 x 125 mg qd) tablets plus one 4 mg methylprednisolone tablet bid, spaced approximately 12 hours apart
16020138|NCT02737319|Drug|Rosuvastatin|40 mg of rosuvastatin before angioplasty
16020139|NCT02737306|Drug|PRO 140|Two 1 mL injections, 175mg/ml each, of PRO 140 to opposite sides of the abdomen.
16020140|NCT02737293|Other|Control Diet|4-week intake of Control Diet 5 day rotating menu
16020141|NCT02737293|Other|Med Diet|4-week intake of Med Diet 5 day rotating menu
16020142|NCT02737293|Other|Med Diet + Whole Egg|4-week intake of Med Diet plus Whole Egg 5 day rotating menu
16020143|NCT02737280|Device|Airvo (TM, Fisher & Paykel Healthcare) - High flow oxygen therapy|High flow nasal cannula therapy with Airvo (TM, Fisher & Paykel Healthcare) device
16020144|NCT02737280|Device|MedKit Finland - Usual oxygen therapy|Oxygen therapy with normal nasal cannula (for example MedKit Finland) 0-2 l/min
16020145|NCT02737267|Behavioral|Moderately high protein diet|"After the recruitment randomization of the study participants, the study will consists of a 4-month nutritional intervention (body weight loss period) followed by a second 6-month period (body weight maintenance period) in which the subjects of the study will continue with the assigned diet, but without any energy restriction."
16020146|NCT02737267|Behavioral|Low fat diet|"After the recruitment randomization of the study participants, the study will consists of a 4-month nutritional intervention (body weight loss period) followed by a second 6-month period (body weight maintenance period) in which the subjects of the study will continue with the assigned diet, but without any energy restriction.the energy derived from fat"
16020147|NCT02737254|Drug|Oxytocin|40 IU/ML nasal spray. One administration: children <40kg administer 12IU, children >40kg administer 24IU.
16020148|NCT02737254|Drug|Placebo|NaCl 0,9 % nasal spray.
16020149|NCT02737254|Other|Secure CBM training|Children are trained to interpret ambiguous maternal behavior in a secure way.
16020150|NCT02737254|Other|Neutral CBM training|Children receive a training unrelated to the interpretation of maternal behavior.
16020151|NCT02737241|Procedure|Low power Holmium laser enucleation of the prostate|HoLEP entails dissection of the whole median and lateral prostatic lobes off the surgical capsule via a retrograde approach starting at the apex. The enucleated lobes were pushed to the bladder followed by hemostasis of the prostate bed then intravesical morcellation of the enucleated adenoma. The procedure entails power setting of 50W holmium laser energy.
16020152|NCT02737241|Procedure|High power Holmium laser enucleation of the prostate|HoLEP entails dissection of the whole median and lateral prostatic lobes off the surgical capsule via a retrograde approach starting at the apex. The enucleated lobes were pushed to the bladder followed by hemostasis of the prostate bed then intravesical morcellation of the enucleated adenoma. The procedure entails power setting of 100W holmium laser energy.
16020153|NCT02737228|Drug|CG200745 PPA|CG200745 PPA IV every week three times per cycle (4 weeks)
16020154|NCT02737228|Drug|Gemcitabine|1000 mg/m^2 intravenously every week three times per cycle (4 weeks)
16020155|NCT02737228|Drug|Erlotinib|100 mg per oral daily per cycle (4 weeks)
16020156|NCT02737215|Device|CPAP|patients will receive CPAP therapy with Auto-CPAP
16020157|NCT02737202|Drug|saracatinib|Subjects will receive enough tablets for 90 days +/- 14 days at each visit. Subject will have visits every 90 days for drug accountability as well as safety and efficacy testing to include pulmonary function testing, laboratory testing to include liver and kidney profile, urine pregnancy testing at each visit, vital signs, physical examination - any medically significant changes from baseline visit will be recorded, all adverse events will be monitored until resolution.
16020303|NCT02736058|Device|Trans-vaginal sonography|
16089251|NCT02242318|Drug|Placebo|
16020158|NCT02737189|Procedure|Mechanical embolectomy|Mechanical embolectomy with Solitaire stentriever in conjunction with manual aspiration
16020159|NCT02737189|Drug|Medical Treatment|Best Medical Treatment and maximum supportive care, not including mechanical thrombectomy, no intra arterial treatment
16020160|NCT02737176|Other|Tobacco cessation intervention|"The nicotine dependence status is evaluated by the Fagerstrom Test for Nicotine Dependence test; those who 3 or more score are eligible for the intervention.
~During the study, attending doctors implement a tobacco cessation intervention with standard treatments for above oral diseases.
~Even if the subjects failed to abstain from smoking, the treatment is continued.
~In case of the use of the nicotine replacement therapy, The investigators supply NRTs (nicotine patch or gum) for 2 weeks as a free of charge, and later the subjects themselves purchase it as over the counter (OTC) drugs at a pharmacy."
16020161|NCT02737150|Device|CoreValve Evolut R|
16020162|NCT02737150|Device|Edwards Sapien 3|
16020163|NCT02737150|Procedure|Local anesthesia with conscious sedation|
16020164|NCT02737150|Procedure|General anesthesia|
16020165|NCT02737137|Procedure|Manual measurement|Monitoring by ultrasound, Neurostimulation and Measurement Manual of the injection pressure of the local anesthetic
16020166|NCT02737137|Procedure|Measurement with a gauge|Monitoring by ultrasound, Neurostimulation and measurement with a gauge of the pressure of injection of the local anesthetic
16020167|NCT02737124|Drug|Acetaminophen|Acetaminophen will be given 24 hours before scheduled surgery.
16020168|NCT02737124|Other|Placebo|Placebo will be given to subjects 24 hours before scheduled surgery.
16020169|NCT02737111|Behavioral|Initial Screening Process|The doctor who meets with the family to share the diagnosis will give the participants a flyer about the research study at the end of their consultation and will briefly explain the study aim and purpose. Following this, the ICC Service Clinical Nurse Specialists (CNS) and the primary researcher will identify patients who meet the inclusion and exclusion criteria and all patients who are eligible to take part will be contact by a CNS shortly after a child receives a diagnosis to follow up with the family, and ask permission for the primary researcher to contact the child's parents to discuss the study.
16020170|NCT02737111|Behavioral|Information and Informed Consent|The researcher will contact parents of patients who agreed some weeks after receiving the diagnosis, check inclusion criteria, and information sheets will be provided. Individuals who consent to participate will arrange to meet with the researcher in their family home or at the hospital. When they meet, the researcher will go through the participant information sheet with the individuals, and gain written consent for participation
16020171|NCT02737111|Behavioral|Interview|Families who wish to take part will be invited to participate in an interview 2-3 months after they received the diagnosis from the hospital. At least ten families (and therefore at least 30 individuals including children with the diagnosis, parents and siblings) will be interviewed separately, about their experiences of the communication about the diagnosis to them, their child or their siblings. Younger children may do some drawings with the researcher about their experiences, and the researcher will ask questions about these drawings.Participants can be included even if not all family members wish to take part.
16020172|NCT02737111|Behavioral|Validated Questionnaires|Each member of the family will complete the mood and quality of life questionnaires.
16020173|NCT02737111|Behavioral|Debrief|At the end of each interview the research will explore with the individual to discuss how they found the experience and answer any questions they might have and review the questionnaires that they completed. The researcher will then meet with children and parents together to discuss the experience as a family.Information will be shared with families about options for accessing support including the paediatric psychology service at the hospital or local support services, if they wish. After the interviews, the researcher will send a letter to participants GP and medical team to inform them that they are taking part.
16020174|NCT02737098|Other|Enhanced Implementation Strategy|The enhanced implementation strategy will add external facilitation to the standard VA implementation strategies. External facilitation will begin with an assessment of the current workflow at the VHA Medical Center and the affiliated CBOCs using System Redesign methods. The external facilitation team will then generate a clinical workflow chart that describes the current process of care. With advice from the external facilitation team, the local champion will then incorporate the clinical process of the TOP intervention into the current clinical workflow chart, making changes to the TOP intervention and/or current clinical workflow as needed. The local champion will also meet monthly with external facilitators to troubleshoot and make refinements.
16020175|NCT02737098|Other|Standard Implementation Strategy|Standard VA implementation strategies will include disseminating a clinical intervention manual, a local champion guide, care manager training materials, PTSD case-finder tool, and technical support from the facility level telehealth technician. Internal facilitation will be conducted by the designated local champion. In addition, each VAMC will receive funds to hire a full time telephone care manager.
16020176|NCT02737085|Biological|Anti-CD19 CAR-T cells and Anti-CD20 CAR-T cells|Patients receive autologous-derived CD19-targeted CAR-T cells following CD20-targeted CAR-T cells after receiving lymphodepleting chemotherapy.
16020177|NCT02737072|Drug|LY2510924|Administered SQ
16020178|NCT02737072|Drug|Durvalumab|Administered IV
16020179|NCT02737059|Drug|Naloxegol|25mg daily
16020180|NCT02737059|Drug|Codeine|30mg 4 times daily
16020181|NCT02737059|Drug|codeine placebo|4 times daily (placebo will be made to match the codeine)
16020182|NCT02737059|Drug|naloxegol placebo|placebo will match naloxegol, given daily
16020183|NCT02737046|Drug|Belinostat|Belinostat will be administered as 1,000 mg/m2 IV infusion over 30 minutes on Days 1- 5 every 21 days (Exception as per FDA-approved Package Insert: In patients known to be homozygous for the UGT1A1*28 allele, the starting belinostat dose must be 750mg/m2) for up to 8 cycles.
16020184|NCT02737046|Drug|Zidovudine|Zidovudine shall be administered in the outpatient setting as 300 mg tablets orally (PO), three times daily (TID) for 21 days on cycles 1 to 8, followed by maintenance therapy (+/- IFN-alfa) up to the end of Month 12.
16020185|NCT02737046|Drug|Interferon-Alfa-2b|OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months.
16020257|NCT02736500|Drug|22 GBq 177Lu-DOTATATE|Patients with risk factors for late renal toxicity will be administered with 6 cycles of 3.7 GBq (100 mCi) each, up to the total cumulative activity of 22 GBq (600 mCi)177Lu-DOTATATE
16020186|NCT02737046|Drug|Pegylated Interferon-Alfa-2b|OPTIONAL: For subjects receiving interferon therapy at baseline, continue Interferon alfa-2b 5 million IU daily or pegylated interferon alfa-2b 1.5 μg/kg once weekly, subcutaneously (SQ) for up to 12 months.
16020187|NCT02737033|Drug|Rhodiola|Rhodiola rosea 800mg
16020188|NCT02737033|Drug|Placebo|innocuous pill manufactured to mimic Rhodiola
16020189|NCT02737020|Drug|Rhodiola|Rhodiola rosea 200mg pill up to four times a day
16020190|NCT02737020|Drug|Placebo|up to four times a day
16020191|NCT02737007|Drug|[14C]-GSK3191607|[14C]-GSK3191607 is a solution to be administered intravenously as a single dose infusion over 15 minutes. It is a radio-labeled product; 100 mcg of [14C]-GSK3191607 contains approximately 7.4 kilobecquerel (kBq) of [14C] radioactivity.
16020192|NCT02736994|Drug|PIP toothbrush cleaner® (Chrisal, Lommel, Belgium).|Probiotic
16020193|NCT02736994|Drug|Corega Tabs Anti-bacteria®|Cleansing tablet -Corega Tabs Anti-bacteria® (GlaxoSmithKline Consumer Healthcare SA, Genval, Belgium)
16020194|NCT02736994|Other|Water|Water
16020195|NCT02736981|Behavioral|Behavioral Weight Loss (BWL)|The intervention represents an adapted version of gold-standard evidence based adult behavioral weight loss that has been tailored specifically to meet the needs of 18-25 year olds. The program includes personalized dietary and physical activity prescriptions, training in behavioral strategies, weekly lesson content, and reporting of key behaviors and personalized feedback and coaching.
16020196|NCT02736981|Behavioral|BWL + Autonomous Motivation|The intervention represents an adapted version of gold-standard evidence based adult behavioral weight loss that has been tailored specifically to meet the needs of 18-25 year olds. The program includes personalized dietary and physical activity prescriptions, training in behavioral strategies, weekly lesson content, and reporting of key behaviors and personalized feedback and coaching. Participants in this arm will receive coaching that places an increased emphasis on their values and personal choices, and also have the option to attend several experiential group sessions that will help those interested to apply the material and skills they are being taught (e.g., cooking demonstration, circuit training class).
16020197|NCT02736981|Behavioral|BWL + Extrinsic Motivation|The intervention represents an adapted version of gold-standard evidence based adult behavioral weight loss that has been tailored specifically to meet the needs of 18-25 year olds. The program includes personalized dietary and physical activity prescriptions, training in behavioral strategies, weekly lesson content, and reporting of key behaviors and personalized feedback and coaching. Participants in this arm will have the opportunity to receive small monetary incentives in weeks 2-24 for tracking weight and calorie intake, and will be eligible for a raffle based on weight loss.
16020200|NCT02736955|Drug|Valbenazine|
16020201|NCT02736942|Procedure|Laparoscopic TME|Laparoscopic Total Mesorectal Excision
16020202|NCT02736942|Procedure|TaTME|Transanal Total Mesorectal Excision
16020203|NCT02736929|Behavioral|Cognitive Processing Therapy - Cognitive|CPT-C is a brief cognitive behavioral treatment for PTSD. It consists of 2 hours of therapy each week for 6 weeks (i.e., two sessions).
16020204|NCT02736916|Radiation|HS-WBRT PCI|LD-SCLC patients with HS-WBRT PCI
16020205|NCT02736916|Radiation|Conventional PCI|LD-SCLC patients with conventional PCI
16020206|NCT02736903|Behavioral|PennFit mobile individual intervention|PennFit (individual) is a mobile app intervention. Participants received a Fitbit physical activity tracking device and an introductory physical activity promotion session emphasizing the health benefits of physical activity and building skills for daily exercises. Participants used the PennFit app (individual) to record and monitor their own physical activity progress.
16020207|NCT02736903|Behavioral|PennFit mobile online network intervention|PennFit (online network) is a mobile app intervention. Participants received a Fitbit physical activity tracking device and an introductory physical activity promotion session emphasizing the health benefits of physical activity and building skills for daily exercises. Participants used the PennFit app (online network) to record and monitor their own physical activity progress. They could see both their own information and the profiles and activity logs of the three other women assigned to their network. In addition, they could send messages to the network through an instant chatting tool.
16020208|NCT02736890|Drug|Botulinum Toxin A|Subjects will receive subcutaneous Botulinum Toxin A injections into the marked painful region. The syringes will be prepared by a third party prior to the injection and the administrator of the procedure will be blinded to syringe content. This physician will be performing the injections under sterile conditions. Local anesthesia, EMLA (lignocaine/prilocaine eutectic mixture) cream, up to 4 grams, will be applied topically for local anesthesia. After 50 minutes, the cream will be cleaned off. Overlying skin will be sterilized with either betadine or alcohol solution.
16020209|NCT02736890|Drug|Placebo|Subjects will receive subcutaneous placebo injections into the marked painful region. The syringes will be prepared by a third party prior to the injection and the administrator of the procedure will be blinded to syringe content. This physician will be performing the injections under sterile conditions. Local anesthesia, EMLA (lignocaine/prilocaine eutectic mixture) cream, up to 4 grams, will be applied topically for local anesthesia. After 50 minutes, the cream will be cleaned off. Overlying skin will be sterilized with either betadine or alcohol solution.
16020210|NCT02736877|Procedure|Lumera Microscope with OCT RESCAN|corneal transplantation guided by Lumera Microscope with OCT RESCAN
16020211|NCT02736877|Procedure|Conventional Microscope|corneal transplantation guided by Conventional Microscope
16020212|NCT02736851|Other|Home-based telemedicine group|"All patients referring to the rehabilitation service as out-patients underwent in-hospital a specific exercise program for the neck. Patients are instructed individually by a physical therapist to perform several types of exercises and, from the first rehabilitation session, are encouraged to exercise regularly at home. Written and illustrated material reporting home exercises is provided to all patients.
~At the end of out-rehabilitation program, according to a randomization list, patients are randomized in 2 groups and those included in a Home-Based Telemedicine (HBT) program are followed up by a nurse tutor at home for a 6-month period."
16020256|NCT02736500|Drug|28 GBq 177Lu-DOTATATE|Patients without risk factors (particularly long standing and poorly controlled diabetes and hypertension) for late renal toxicity will be administered with 5 cycles of 5.5 GBq (150 mCi) each, up to the total cumulative activity of 28 GBq (750 mCi) of 177Lu-DOTATATE.
16089741|NCT02238535|Drug|Ventavis|
16020213|NCT02736838|Device|tcpO2|Skin oxygenation will be measured by tcpO2, and microvascular flow with Laser Doppler. Measurements will be made inserting probes in sacrum, trochanters, elbows and heels, before and after the end of each decubitus lying period, and in every position and angle. Pressure: Continuous pressure measurements will be made in sacrum, trochanters, elbows and heels. Measures will be carried out at sessions separated at intervals of 7 days, with 0 to 4 hours of experimental exposure to pressure, different bed angles (0º, 30º, 45º), and lateral decubitus tilts (30, 90). Bioimpedance will be performed at baseline early in the morning, fasting and after emptying the bladder. Subjects will be lying without clothes, in a supine position on the bed, with a distance of at least 25 cm between thighs. The measurement will be made in single frequency mode (50 kHz , 400 μARMS) with a tetrapolar electrode arrangement.
16020214|NCT02736838|Device|Laser Doppler|
16020215|NCT02736825|Device|Ulthera System with standard transducer|Focused ultrasound energy delivered below the surface of the skin using commercially available transducer to deliver one line of treatment at a time
16020216|NCT02736825|Device|Ulthera System with prototype 2 simulines transducer|Focused ultrasound energy delivered below the surface of the skin using new transducer to deliver two lines of treatment simultaneously
16020217|NCT02736812|Biological|French Lyophilized Plasma|"During the pre-hospital phase, the main events related to this arm are
~Blood samples taken before treatment (TP, fibrinogen, platelets, RBC, grouping)
~Usual pre-hospital care according to recommendations in best practices
~Administration of FLYP"
16020218|NCT02736812|Biological|Normale Saline Solution|"During the pre-hospital phase, the main events related to this arm are
~Blood samples taken before treatment (TP, fibrinogen, platelets, RBC, grouping)
~Usual pre-hospital care according to recommendations in best practices
~Administration of Normale Saline Solution"
16020219|NCT02736799|Device|Sham vibrating capsule|Sham device without vibration
16020220|NCT02736799|Device|Vibrant Capsule (1 vibration)|1 vibration/min
16020221|NCT02736799|Device|Vibrant Capsule (3 vibration)|3 vibration/min
16020222|NCT02736799|Device|Vibrant Capsule (5 vibration)|5 vibration/min
16020223|NCT02736773|Other|xenograft material to slow resorption|xenograft material to slow resorption (Bio-Oss®)
16020224|NCT02736760|Drug|Daylight photodynamic therapy using Methylaminolevulinate (MAL)|"In the Daylight photodynamic therapy arm the patients will apply a sunscreen to the whole face which is followed by lesion preparation of AKs. Following this, MAL will be applied in a thin layer to the whole face. Within 30 min after MAL application patients expose themselves to daylight for 2 hours.
~5 photodynamic therapy treatment sessions (visits 1-5) will be performed within 18 months."
16020225|NCT02736760|Procedure|Cryosurgery|In the control group, cryosurgery as standard reference therapy will be performed at visit 1, and in case of non-cleared or newly occurred AKs at visits 2-5. Cryosurgery of AK lesions will be investigated as standard reference therapy. Single freeze-thaw cryosurgery is performed using an open spraying procedure with liquid nitrogen with nozzle size C. After formation of an ice-ball of the required size, freeze time starts. Freeze time should lie between 5 s and 10 s.
16020226|NCT02736747|Other|Cryotherapy|
16020227|NCT02736747|Other|Placebo|
16020228|NCT02736734|Drug|CRH|CRH injection: 100 µg CRH powder for injection (CRH Ferring) dissolved in 1ml NaCl 0.9%, administration intravenously over the course of 1 minute to avoid side effects.
16020229|NCT02736721|Drug|Peginterferon alfa-2a|Peginterferon alfa-2a in doses between 90 and 450 mcg will be administered subcutaneously once weekly until medically indicated as judged by the treating investigator.
16020230|NCT02736708|Device|probe based confocal laser endomicroscopy|real-time, microscopic imaging of tissue at the cellular level via a small diameter probe.
16020231|NCT02736695|Drug|F-18 AV 1451|Tau binding agent
16020232|NCT02736682|Drug|Single dose antibiotic|Single dose arm receive 2g of IV Ceftriaxone and 500 mgs ofIntra venous Metronidazole given to the mothers 30-60 minutes pre operative.
16020233|NCT02736682|Drug|Multiple dose antibiotic|Multiple dose arm receive 1 g of IV Cetriaxone plus 500 mgs during surgery and there after IV ceftriaxone once a day for 3 days and IV Metronidazole 500mgs during surgery and there after every 8 hours for 3 days.
16020234|NCT02736669|Behavioral|Energy Reduction|
16020235|NCT02736656|Drug|SPN-812 ER|
16020236|NCT02736630|Other|body temperature|intermittant tympanic temperature measurement during surgery
16020237|NCT02736617|Drug|Ibrutinib|Given PO
16020238|NCT02736617|Biological|Obinutuzumab|Given IV
16020239|NCT02736604|Drug|nitrous oxide anesthesia|General anesthesia will be maintained by 40% oxygen (FiO2 0.4) with Nitrous Oxide and volatile anesthetic sevoflurane through laryngeal mask airway (LMA Supreme Size 3/4) or endotracheal tube (Size 7.0-7.5). All patients will receive standard anesthetic care and monitoring
16020240|NCT02736604|Drug|air anesthesia|General anesthesia will be maintained by 40% oxygen (FiO2 0.4) with air and volatile anesthetic sevoflurane through laryngeal mask airway (LMA Supreme Size 3/4) or endotracheal tube (Size 7.0-7.5). All patients will receive standard anesthetic care and monitoring
16020241|NCT02736604|Device|laryngeal mask airway (LMA Supreme Size 3/4|
16020242|NCT02736604|Drug|sevoflurane|
16020243|NCT02736591|Drug|DHEA|Women will receive oral DHEA 25 mg t.d.s. 12 weeks before ICSI.
16020244|NCT02736591|Drug|Growth Hormone-Releasing Hormone|Women will receive 4 IU of growth hormone on day 6 of hMG stimulation in a daily dose of 2.5 mg SC until the day of hCG triggering
16020245|NCT02736591|Drug|Placebo 1|Women will receive an oral placebo similar to DHEA for 12 weeks before ICSI.
16020246|NCT02736591|Drug|Placebo 2|Women will receive a placebo injection similar to growth hormone daily from day 6 of hMG stimulation until the day of hCG triggering.
16020247|NCT02736578|Drug|Cetuximab-IRDye800|Administered intravenously (IV) at 50 or 100 mg
16020248|NCT02736578|Drug|Cetuximab|Administered as a 100 mg IV loading dose
16020250|NCT02736552|Drug|S-1 for 6 months|6 months S-1 after D2 resection
16020251|NCT02736552|Drug|S-1 for 1 year|1 year S-1 after D2 resection
16020252|NCT02736539|Drug|CBS 2004 (galacto-oligosaccharides)|CBS 2004 active treatment
16020253|NCT02736539|Drug|Placebo|Placebo treatment
16020254|NCT02736526|Procedure|recession or resection of the horizontal extraocular muscles|
16020255|NCT02736513|Drug|AZD9291|Patients will receive AZD9291 at a dose of 80 mg once daily.
16020258|NCT02736487|Device|True-Washout-Sham Air Filtration Intervention|This intervention involved three sequential steps: (1) 12 to 20 hours of true air filtration intervention; (2) at least two weeks of washout period; (3) 12 to 20 hours of sham air filtration intervention. In the indoor environment, the portable filtration device drew room air, sent it through filter and active carbon (for true filtration) or active carbon alone (sham filtration) and then delivered processed air back to room air. In the study the portable filtration device processes 2.8 cubic meter of room air per minute. The washout period lasted for at least two weeks where no filtration intervention was implemented.
16020259|NCT02736487|Device|Sham-Washout-True Air Filtration Intervention|This intervention involved three sequential steps: (1) 12 to 20 hours of sham air filtration intervention; (2) at least two weeks of washout period; (3) 12 to 20 hours of true air filtration intervention. In the indoor environment, the portable filtration device drew room air, sent it through filter and active carbon (for true filtration) or active carbon alone (sham filtration) and then delivered processed air back to room air. In the study the portable filtration device processes 2.8 cubic meter of room air per minute. The washout period lasted for at least two weeks where no filtration intervention was implemented.
16020264|NCT02736461|Procedure|Floor repair surgery|
16020265|NCT02736448|Drug|Capecitabine|oral low dose of capecitabine
16020266|NCT02736448|Drug|Lu-PRRT|Lu-PRRT (at 3.7Gbq per cycle x 7 cycles)
16020267|NCT02736448|Drug|SS-LAR|long acting octreotide or lanreotide
16020268|NCT02736435|Device|Magnetic Resonance Guided High Intensity Focused Ultrasound|Direct treatment of uterine fibroids with MR-HIFU
16020269|NCT02736435|Drug|leuprolide acetate for depot suspension|Treatment of uterine fibroids with leuprolide acetate prior to MR-HIFU
16020270|NCT02736422|Other|Hyperpolarised Xenon|Hyperpolarised gas Magnetic resonance imaging (MRI) (3He and 129Xe) has enabled novel methods of in-vivo functional lung imaging that do not rely on the use of ionising radiation.
16020271|NCT02736409|Drug|Oral Budesonide Suspension (OBS)|OBS 2mg twice daily
16020272|NCT02736409|Drug|Placebo|Matching Placebo dose
16020273|NCT02736396|Other|fMRI|Functional MRI scan to be performed
16020274|NCT02736396|Other|Neuropsychological tests|Cognitive assessments will be performed, including Mini Mental State Examination, Rey Auditory Verbal Learning Test, Stroop, Visual Short Term Memory Assessment.
16020275|NCT02736344|Device|BioNIR Ridaforolimus Eluting Coronary Stent|
16020276|NCT02736331|Dietary Supplement|Treatment 1|Treatment 1 Beverage
16020277|NCT02736331|Dietary Supplement|Treatment 2|Treatment 2 Beverage
16020278|NCT02736318|Other|processed osteochondral allograft|
16020279|NCT02736305|Drug|Regorafenib|Once a day for 21 days in a 28 days cycle
16020280|NCT02736292|Behavioral|Mindfulness Practices for Healthcare Professionals|
16020281|NCT02736279|Drug|Dimethyl fumarate|Observation of impact of dimethyl fumarate treatment initiation on mood and gut microbiome over the first 6 months of therapy
16020282|NCT02736266|Drug|Pembrolizumab (MK-3475)|Pembrolizumab given intravenously in 30 min. infusion every 3 weeks
16020283|NCT02736240|Biological|7-valent pneumococcal conjugate vaccine|
16020284|NCT02736240|Biological|13-valent pneumococcal polysaccharide conjugate vaccine|
16020285|NCT02736227|Drug|Tacrolimus Withdrawal and Everolimus Monotherapy|During the first month post-transplant, the subject receives everolimus (about 5-8 ng/mL) and tacrolimus with or without mycophenolic acid as part of standard of care procedures. At one month post-transplant, mycophenolic acid will be stopped and tacrolimus dosage will be reduced while continuing the dosage of everolimus. At three months post-transplant, tacrolimus dosage will be reduced by 50% of the daily dose each week. At four months post-transplant, tacrolimus will be discontinued.
16020286|NCT02736214|Behavioral|Reproductive Life Plan (RLP)|A structured discussion based on the RLP, including information about reproduction and a brochure with the same information.
16020287|NCT02736201|Device|Capacitive diathermy (T-CaRe®)|The instrumental manual therapy with the switched on capacitive diathermy electrode (IMT+ T-CaRe® on; n = 10) and the instrumental manual therapy with the switched off capacitive diathermy electrode (IMT+ T-CaRe® off; n = 10) will be bilaterally treated for 4 weeks (1 treatment per week during 10 minutes) in the lumbopelvic region.
16020288|NCT02736201|Other|Instrumental manual therapy|Bilateral longitudinal massage in the lumbar region (110 mm; 5 minutes in each side)
16020289|NCT02736188|Drug|Aceneuramic Acid Extended-Release Tablets|
16020290|NCT02736175|Drug|Dexamethasone|
16020291|NCT02736175|Other|Placebo Vehicle|
16020292|NCT02736162|Other|No treatment (intervention) was administered|
16020293|NCT02736149|Drug|ubenimex|
16020294|NCT02736136|Behavioral|joint observation and video feedback|
16020295|NCT02736123|Drug|Nivolumab - Arm A|Nivolumab will be given during the induction phase of the study for 6 weeks. This is followed by surgery. Then maintenance therapy (after recovery from surgery).
16020296|NCT02736123|Drug|Nivolumab + Ipilimumab - Arm B|Nivolumab + ipilimumab during the induction phase of the study for 6 weeks. This is followed by surgery (week 6-8+). Then maintenance therapy will be initiated for up to one year from study drug initial administration ((after recovery from surgery).
16020297|NCT02736084|Behavioral|Positive Psychology|The Positive Psychology intervention consists of 7 exercises that will be completed by the participant with the guidance of a trainer.
16020298|NCT02736071|Drug|Celecoxib|Women will receive oral Celecoxib 200mg 2 hours before the procedure
16020299|NCT02736071|Drug|Tramadol|Women will receive oral Tramadol 100mg 2 hours before the procedure
16020300|NCT02736071|Drug|Placebo 1|Women will receive an oral placebo similar to Tramadol 2 hours before the procedure
16020301|NCT02736071|Drug|Placebo 2|Women will receive an oral placebo similar to Celecoxib 2 hours before the procedure
16020302|NCT02736058|Device|Trans- abdominal sonography|
16020304|NCT02736058|Procedure|post-operative pathological specimen examination|
16020305|NCT02736045|Device|emWave|Our approach will be to test the impact of this intervention through a smartphone application, emWave software, which will be provided to all our subjects. emWave is a tool that reduces stress by allowing individuals to be less reactive, think clearly, and make good decisions, especially under pressure. Fifty medical residents with high burnout symptoms will be randomized to receive an 8-week intervention (emWave - computer based resilience training program).
16020306|NCT02736032|Procedure|Embryo transfer|The transfer of cryopreserved-thawed embryos inside the uterus aiming to achieve pregnancy
16020307|NCT02736032|Procedure|Serum Estradiol and Progesterone levels|Serum estradiol and serum progesterone levels in blood on the day of start of progesterone supplementation
16020308|NCT02736032|Drug|GnRH agonist|GnRH agonist given on day 21 of the cycle preceding the embryo transfer
16020309|NCT02736032|Drug|External Estradiol|Estradiol started on day1 of the cycle for endometrial prepartaion
16020310|NCT02736032|Drug|Progesterone|progesterone as luteal phase support start after endometrium is well prepared
16020311|NCT02736019|Drug|Celecoxib|Women will receive oral Celecoxib 200mg 2 hours before the procedure
16020312|NCT02736019|Drug|Tramadol|Women will receive oral Tramadol 100 mg 2 hours before the procedure
16020313|NCT02736019|Drug|Placebo 1|Women will receive an oral placebo similar to Tramadol 2 hours before the procedure.
16020314|NCT02736019|Drug|Placebo 2|Women will receive an oral placebo similar to celecoxib 2 hours before the procedure
16020315|NCT02736006|Other|20 meters air dive|"A dive in the depth of 20 m during 40 minutes. The divers will be evaluated before and 30, 60, 180 minutes after a 20 meters air dive. Venous bubbles will be detected by precordial Doppler 30 minutes after the dive.
~In association with this Doppler, Flow Mediated Dilation, blood samples analysing inflammatory and thrombotic factors and other biomarkers will be explored before and after the dive in order to know how vascular and respiratory tracts in this environment react."
16020316|NCT02735980|Drug|Prexasertib|Administered IV
16020317|NCT02735967|Other|manual therapy|the positional release techniques will be performed while maintaining this position for 90 seconds procedure is repeated 3 times. Then, the therapist performs the ischemic compression technique on the myofascial trigger point, the compression is maintained for 90 seconds by 3 replications.
16020318|NCT02735967|Device|diadynamic current|Through an electrotherapy device were applied diadynamic in that myofascial trigger point previously marked. 4 minutes from the fixed two-phase mode will be applied (DF), 4 minutes long periods (LP) and 4 minute short periods (CP), the first and second intensely in the sensitive line and the third motor threshold, both supportable according to each patient.
16020319|NCT02735954|Other|Marijuana|This is an observational study looking at the effects of marijuana on health, including lung health and sleep.
16020320|NCT02735928|Device|Pressurized intraperitoneal aerosol chemotherapy with cisplatin and doxorubicin|After insufflation of a 12 mmHg of capnoperitoneum at 37 °C, two balloon trocars will be placed. Parietal biopsies will be taken and ascites (< 500cc) will be removed. A nebulizer will be connected to a high-pressure injector and will be inserted into the abdomen through a trocar. A pressurized aerosol containing cisplatin at a dose of 7.5 mg/m2 body surface in 150 ml NaCl 0.9 % followed by doxorubicin at a dose of 1.5 mg/m2 body surface in a 50 ml NaCl 0.9% solution will be applied via a nebulizer immediately. Then, the system will be kept in steady-state for 30 min (i.e.: application time).
16020321|NCT02735915|Biological|Herpes Zoster Vaccine GSK1437173A|Intramuscular injection
16020322|NCT02735902|Drug|Vitamin K antagonist or direct oral anticoagulant treatment|"The Vitamin K antagonist or direct oral anticoagulant treatment will be administered to obtain an International Normalized Ratio between 2 and 3 as recommended if the treatment is AVK.
~The Direct oral anticoagulant treatment : Apixaban 5 mg x2 or 2.5 mg X2, Edoxaban 30 ou 60 mg"
16020323|NCT02735902|Drug|Aspirin|"Daily dose is between 75 mg and 100 mg.
~Allergic reactions to aspirin may be observed in rare cases. In case of suspicion of allergy, treatment with aspirin is stopped."
16020324|NCT02735889|Other|No Carbonation|500 ml of beverage consisting of water + 10% glucose and no carbonation
16020325|NCT02735889|Other|Low carbonation|500 ml of beverage consisting of water + 10% glucose and low carbonation
16020326|NCT02735889|Other|High carbonation|500 ml of beverage consisting of water + 10% glucose and high carbonation
16020327|NCT02735876|Drug|acalabrutinib|
16020328|NCT02735876|Drug|ibrutinib|
16020329|NCT02735876|Drug|rituximab|
16020330|NCT02735863|Drug|ABX464|50 mg or 150mg once daily for 28 days
16020331|NCT02735863|Drug|Placebo|ABX464 matching placebo
16020332|NCT02735850|Drug|L19-IL2|L19-IL2 added to SBRT
16020333|NCT02735850|Radiation|SBRT|
16020334|NCT02735850|Other|No intervention|
16020335|NCT02735837|Drug|Doxycycline Group|Doxycycline 3% topical gel was put into the periodontal pocket using an insulin syringe
16020336|NCT02735837|Drug|placebo topical gel|placebo topical gel was put into the periodontal pocket using an insulin syringe
16020337|NCT02735824|Procedure|blood sampling and skin biopsy|Nucleated blood cells and/or fibroblasts from skin biopsy will be used for genetic testing and functional assays. Blood serum will be used for antibody and cytokine measurement.
16020338|NCT02735824|Procedure|blood sampling or mouth swap|specimen will be used for genetic testing, results compared to patients
16020339|NCT02735824|Procedure|blood sampling|Nucleated blood cells and/or fibroblasts from skin biopsy will be used for genetic testing and functional assays. Blood serum will be used for antibody and cytokine measurement.
16020340|NCT02735811|Device|Assesment of long-term outcome of ICD patients|Evaluation during follow-up of the occurrence of complications related to ICD implantation and of death
16020341|NCT02735798|Drug|MM-302|
16020342|NCT02735798|Drug|Trastuzumab|
16020343|NCT02735785|Behavioral|Harnessing Online Peer Education (HOPE) Social Media Intervention|
16020344|NCT02735772|Procedure|transobturator approach for paravaginal repair|using TOT needle to apply suturs to white line
16020369|NCT02735707|Drug|Fixed-duration higher dose Hydrocortisone|100mg of intravenous hydrocortisone will be administered every 6 hours for up to 7 days.
16020432|NCT02735395|Drug|Metronidazole 400 (14 days)|Subjects will intake Metronidazole 400 mg. for 14 days, starting immediately after the first session of Scaling and Root Planing.
16020345|NCT02735759|Device|Photoacoustic flow cytometry device|The device for subjects enrolled on cohort 2 will be completed on day 0 (immediately after venous thromboembolism diagnosis and prior to anticoagulation therapy), day 7 ± 3 days after initiation of anticoagulation therapy, one week ± 3 days after completion of planned anticoagulation therapy and one month ± 3 days after completion of planned anticoagulation therapy. Anticoagulation therapy is part of the patient's normal standard of care and is not part of this study however data from what therapy was received may be captured. Patients will then be followed in hematology clinic to monitor the venous thromboembolism recurrence every 3 months for one year.
16020350|NCT02735733|Device|Cold Bakri Balloon|In the room temperature arm, the bakri balloon will be inserted through the vagina and placed inside the uterus and filled with room temperature saline. In the cold arm, the same intervention will performed, however, the bakri balloon will be filled with cold saline at 32 degrees Fahrenheit.
16020351|NCT02735720|Other|TEVAR|Thoracic endovascular aortic repair, which includes the implantation of stent-graft in the thoracic aorta to repair the lesion. This may be done with a variety of stent-graft brands and types. The type and brand of stent-graft is left to the discretion of the care taking physician.
16020352|NCT02735720|Other|Non-TEVAR medical treatment|Any clinical management by physicians caring for these patients. This includes whatever blood pressure and heart rate medication is prescribed by the treating physician, without any surgery. The type and dosage of medication is left to the discretion of the care taking physician.
16020353|NCT02735707|Drug|Fixed-duration Hydrocortisone|50mg of intravenous hydrocortisone will be administered every 6 hours for up to 7 days.
16020354|NCT02735707|Drug|Shock-dependent hydrocortisone|Patient will receive 50mg IV hydrocortisone every 6 hours while the patient is in septic shock
16020355|NCT02735707|Drug|Ceftriaxone|The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.
16020356|NCT02735707|Drug|Moxifloxacin or Levofloxacin|The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.
16020357|NCT02735707|Drug|Piperacillin-tazobactam|The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.
16020358|NCT02735707|Drug|Ceftaroline|"The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.
~Ceftaroline is not available at commencement"
16020359|NCT02735707|Drug|Amoxicillin-clavulanate|The duration and dose of empiric antibiotics will be determined by the treating clinician and local guidelines or practice.
16020360|NCT02735707|Drug|Macrolide administered for 3-5 days|"Standard course of macrolide therapy, discontinued between study day 3 and the end of study day 5.
~The dosing of and route of administration is not protocolised, the following guidance is provided:
~Initial IV administration of a macrolide is strongly preferred
~The preferred IV macrolide is azithromycin, but IV clarithromycin may be substituted.
~The preferred enteral macrolide is azithromycin, but enteral clarithromycin or roxithromycin may be substituted."
16020361|NCT02735707|Drug|Macrolide administered for up to 14 days|"Extended course of macrolide therapy discontinued at the end of study day 14 or hospital discharge (whichever occurs first).
~The dosing of and route of administration is not protocolised, the following guidance is provided:
~Initial IV administration of a macrolide is strongly preferred
~The preferred IV macrolide is azithromycin, but IV clarithromycin may be substituted.
~The preferred enteral macrolide is azithromycin, but enteral clarithromycin or roxithromycin may be substituted."
16020362|NCT02735707|Drug|Five-days oseltamivir|Oseltamivir administered enterally twice daily for 5 days or until hospital discharge (whichever occurs first)
16020363|NCT02735707|Drug|Ten-days oseltamivir|Oseltamivir administered enterally twice daily for 10 days or until hospital discharge (whichever occurs first)
16020364|NCT02735707|Drug|Lopinavir/ritonavir|Lopinavir/ritonavir 400/100mg administered enterally, or 5ml 80/20mg per mL solution suspension via gastric tube, every 12 hours. Administered for a minimum of 5 days, including if discharged from ICU prior to end of study day 5. For patients discharged from ICU between study day 6 and study day 14, lopinavir/ritonavir is ceased at ICU discharge. Lopinavir/ritonavir is ceased at the end of study day 14 if the patient remains in ICU.
16020365|NCT02735707|Drug|Hydroxychloroquine|Loading dose of 800mg hydroxychloroquine administered enterally every 6 hours until 2 doses have been administered. Subsequently, 400mg hydroxychloroquine will be administered enterally every 12 hours for 12 doses or ICU discharge (whichever occurs first).
16020366|NCT02735707|Drug|Hydroxychloroquine + lopinavir/ritonavir|"Lopinavir/ritonavir 400/100mg administered enterally, or 5ml 80/20mg per mL solution suspension via gastric tube, every 12 hours. Administered for a minimum of 5 days, including if discharged from ICU prior to end of study day 5. For patients discharged from ICU between study day 6 and study day 14, lopinavir/ritonavir is ceased at ICU discharge. Lopinavir/ritonavir is ceased at the end of study day 14 if the patient remains in ICU.
~Loading dose of 800mg hydroxychloroquine administered enterally every 6 hours until 2 doses have been administered. Subsequently, 400mg hydroxychloroquine will be administered enterally every 12 hours for 12 doses or ICU discharge (whichever occurs first)."
16020367|NCT02735707|Drug|Interferon-β1a|IFN-β1a 10 μg will be administered as an intravenous bolus injection via a central or peripheral line. IFN-β1a will be administered once daily for 6 days or until ICU discharge, whichever occurs first.
16020368|NCT02735707|Drug|Anakinra|"A loading dose of 300mg anakinra will be administered as a bolus via central or peripheral line. This is followed by maintenance doses of 100mg of anakinra administered very 6 hours.
~In patients with renal impairment, anakinra will be administered on alternate days."
16020370|NCT02735707|Drug|Tocilizumab|"Tocilizumab will be administered as a single dose of 8mg/kg estimated or measured body weight, with a maximum total dose of 800mg.
~Tocilizumab will be administered as an IV infusion via central or peripheral line over a one-hour period."
16020371|NCT02735707|Drug|Sarilumab|Sarilumab will be administered as a single dose of 400mg, via IV infusion through peripheral or central line over a one-hour period.
16020372|NCT02735707|Drug|Vitamin C|Vitamin C 50mg/kg administered IV every 6 hours for 16 doses
16020373|NCT02735707|Drug|Therapeutic anticoagulation|Patients will be administered either low molecular weight heparin or unfractionated heparin to achieve systemic anticoagulation. Either agent may be used and the same patient may be switched between UFH and LMWH at the discretion of the treating clinician.
16020374|NCT02735707|Drug|Simvastatin|Simvastatin 80mg administered once daily via enteral route, while the patient remains in hospital up to 28 days after randomisation
16020375|NCT02735707|Biological|Convalescent plasma|Patients will recieve at least one and no more than two units of ABO compatible convalescent plasma within 48 hours of randomisation.
16020376|NCT02735707|Other|Protocolised mechanical ventilation strategy|See Domain Specific Appendix for a complete description of protoclised invasive mechanical ventilation strategy.
16020377|NCT02735707|Drug|Eritoran|Eritoran initiated with a 26.24 mg loading dose (6.56 mg/h IV for 4 hours), followed by a second 13.12 mg loading dose (6.56 mg/h IV for 2 hours) at 12 hours after initiation. Patients will then receive twenty-six 6.56 mg maintenance doses (3.28 mg/h IV for 2 hours) every 12 hours thereafter (total of 14 days). Dosing will be stopped if the patient is discharged from hospital
16020378|NCT02735707|Drug|Apremilast|Apremilast administered 30mg twice daily for 14 days or until hospital discharge, whichever occurs first.
16020379|NCT02735707|Drug|Aspirin|Aspiring administered at either 75mg or 100mg once per day for 14 days or until hospital discharge, whichever occurs first.
16020380|NCT02735707|Drug|Clopidogrel|Clopidogrel administered 75 mg once per day for 14 days or until hospital discharge, whichever occurs first.
16020381|NCT02735707|Drug|Prasugrel|"If patient is aged less than 75 years and measured or estimated weight if 60kg or more, and initial loading dose of prasugrel 60 mg will be administered, followed by maintenance dose of 10 mg per day.
~If patient's age is more than 75 years, or measured or estimated weight is less than 60kg, an initial loading dose of 60mg will be administered, followed by 5mg per day.
~Prasugrel will be administered for 14 days or until hospital discharge, whichever occurs first."
16020382|NCT02735707|Drug|Ticagrelor|Ticagrelor administered enterally at 60mg twice daily for 14 days or until hospital discharge, whichever occurs first.
16020383|NCT02735694|Drug|Cycloserine|Capsule containing 250 mg of Cycloserine
16020384|NCT02735694|Drug|Placebo|Sugar capsule manufactured to mimic Cycloserine 250 mg capsule
16020385|NCT02735681|Procedure|meibomian gland probing|Investigator will do baseline (OSDI) questionnaires prior to probing as well as at 1 week (at home), 1 month, 3months, and 6 months at office visits.
16020386|NCT02735681|Procedure|Left eye Meibomian Gland Probing Control Group|There will be no probing in the left eye. This will be used as a control for the right eye.
16020387|NCT02735668|Other|Shoulder Conventional Exercises|"The protocol consists in:
~• Flexibility and Strengthening Exercises of the shoulder muscles conventionally performed in shoulder pathology treatment:
~Mobilisation Joint Exercises.
~Isometrics and Resisted Exercises (elastic bands)."
16020388|NCT02735668|Other|Multimodal Physiotherapy|"The protocol consists in:
~Dry Needling in active myofascial trigger points related to shoulder joint (optimal hygiene and disinfection before and after needling). Special care in muscles located in the arm in women with axillary node dissection.
~If Upper Limb Neural Tension Test is positive, neurodynamic techniques will be included."
16020389|NCT02735668|Other|Scapular exercises|"The protocol consists in:
~Scapula-focused exercises: based on evaluation of scapular dyskinesis and Kinetic Medial Rotation Test as well as inherent characteristics of each woman, individualized scapular exercises were prescribed based on a motor control approach with emphasis on obtaining a neutral scapular orientation."
16020390|NCT02735668|Behavioral|Therapeutic Education|"The protocol consists in:
~Therapeutic Education about chronic shoulder pain using a slide show, anatomical models, providing information and analysis of real clinical cases."
16020391|NCT02735655|Other|Physician's opinion|To get physician's opinion about the current global state of gastrointestinal endoscopy training programs and to identify the unmet needs and how to improve it through a web based questionnaire.
16020392|NCT02735642|Behavioral|SMART Randomization 1 - Referral|Participants will be randomized to receive standard referral to link to HIV care. When successfully linked to care, they will receive SMS reminders combined with health status surveys at 3, 6, 9, and 12 months. All participants will have viral loads and CD4 collected at baseline and at 12 months, viral loads collected again and an exit interview completed.
16020393|NCT02735642|Behavioral|SMART Randomization 1 - Referral and SMS|Participants will be randomized to receive referral plus SMS to link to HIV care. When successfully linked to care, they will receive SMS reminders combined with health status surveys at 3, 6, 9, and 12 months. All participants will have viral loads and CD4 collected at baseline and at 12 months, viral loads collected again and an exit interview completed.
16020394|NCT02735642|Behavioral|SMART Randomization 2 - SMS|Those that have not linked to care after the first randomization, will be re-randomized to receive an SMS message. When successfully linked to care, they will receive SMS reminders combined with health status surveys at 3, 6, 9, and 12 months. All participants will have viral loads and CD4 collected at baseline and at 12 months, viral loads collected again and an exit interview completed.
16020395|NCT02735642|Behavioral|SMART Randomization 2 - Incentive|Those that have not linked to care after the first randomization, will be re-randomized to receive a one-time economic incentive. When successfully linked to care, they will receive SMS reminders combined with health status surveys at 3, 6, 9, and 12 months. All participants will have viral loads and CD4 collected at baseline and at 12 months, viral loads collected again and an exit interview completed.
16020396|NCT02735642|Behavioral|High Risk Negative Cohort (N=185)|A subset of negatives identified as 'high risk' from the CAPI baseline survey will be invited to participate in the primary prevention intervention (N=185). They will receive an SMS health promotion message with survey at 6 and 12 months. At 12 months, they will be re-tested for HIV and an exit interview completed.
16020471|NCT02735200|Drug|Application of topical vitamin d3 (Top-D)|Topical Vitamin D3 will be applied on the skin, externally, 1 gram daily for 120 days
16020397|NCT02735642|Other|All participants. Approximately (N=1200)|"HIV testing approaches that females can choose from include: (1) oral fluid HIV self-testing (OHIVST) at their convenience; (2) immediate staff-aided testing at home/mobile site; and (3) a referral to a health care facility where HIV testing will be done by a health care provider (standard facility-based HTS).
~All participants will receive a behavioral CAPI survey at baseline visit, an SMS HIV test experience satisfaction survey, and for those who choose the self-testing option, a staff-administered questionnaire."
16020398|NCT02735629|Drug|CX1739 - 300 mg|Ampakine CX1739 - 300 mg
16020399|NCT02735629|Drug|CX1739 - 600 mg|CX1739 - 600 mg
16020400|NCT02735629|Drug|CX1739 - 900 mg|CX1739 - 900 mg
16020401|NCT02735629|Drug|Placebo|Placebo to 300 mg CX1739
16020402|NCT02735603|Drug|Naltrexone HCl/bupropion HCl|Naltrexone HCl/bupropion HCl extended-release tablet.
16020403|NCT02735603|Other|Placebo|Naltrexone/bupropion placebo-matching tablets.
16020404|NCT02735603|Drug|Moxifloxacin|Moxifloxacin tablet.
16020405|NCT02735590|Drug|Isoniazid|Participants in the Treatment Arm will receive high dose Isoniazid - 15mg per kg body weight, rounded up to the nearest 100 mg; maximum dose 900 mg with Pyridoxine supplementation (25mg).
16020406|NCT02735590|Drug|Rifapentine|Rifapentine based on body weight (>32kg - 50kg: 750 mg; >50kg: 900 mg), given weekly as 12 directly observed treatment (DOT) oral doses, ideally with food, over 3 months.
16020407|NCT02735577|Drug|Disulfiram|Patients will be hospitalized on an inpatient psychiatric unit for 1-7 days to initiate abstinence. An fMRI scan will be performed to examine neural mechanisms of alcohol motivation. Prior to discharge, patients will receive the first dose of disulfiram 500 mg. They will then attend an outpatient clinic every other day for 14 days. At each clinic visit, they will receive 500 mg of disulfiram under supervision. Another fMRI scan examining alcohol motivation will be performed. Following this, all patients will attend the clinic weekly, and will be prescribed disulfiram 250 mg daily to take at home. This will be followed followed by an optional extension of weekly visits taking disulfiram 250 mg daily for another 28 days, for a total of 70 days of disulfiram treatment.
16020408|NCT02735564|Procedure|Bariatric Surgery|
16020409|NCT02735551|Drug|Long Acting Reversible Contraception (LARC)|Same day LARC placement (intervention) of Mirena, Skyla, Paragard, Implanon
16020410|NCT02735551|Other|Referral for Long Acting Reversible Contraception (LARC)|Referral to local clinic for LARC placement of choice (Mirena, Skyla, Paragard, Implanon, etc.)
16020411|NCT02735551|Other|Prescription for Short-Acting Hormonal Contraception|Participants who chose a short-acting hormonal method (e.g. contraceptive pills, ring, or patch) will receive a prescription to the pharmacy of their choice
16020412|NCT02735538|Procedure|osteonecrosis of femoral head group|The patients with osteonecrosis of femoral head will undergo total hip replacement.
16020413|NCT02735538|Procedure|osteoarthritis group|The patients with osteoarthritis will undergo total hip replacement.
16020414|NCT02735525|Device|Smartphone monitoring|Patients will be trained to use the smartphone and the wound surveillance app prior to discharge. Patients will use the app from home to take send digital images of their postoperative wounds and answer a short survey, all of which will be transmitted to a secure database maintained by the UW Department of Surgery and accessible only to UW-employed study personnel. These data will be evaluated by one of three vascular surgery service nurse practitioners (NPs) daily. Patients who have concerning findings either in their images or in their survey answers will be contacted for further evaluation.
16020415|NCT02735512|Other|Cytology Specimen Collection Procedure|Undergo collection of blood and urine samples
16020416|NCT02735512|Other|Laboratory Biomarker Analysis|Samples undergo MDSC clinical assay
16020417|NCT02735499|Drug|onabotulinum toxin A|Onabotulinum toxin A is installed into the bladder and EMDA (Electromotive Drug Application) is applied for 30 minutes
16020418|NCT02735486|Dietary Supplement|Ginger drink|300 ml ginger drink
16020419|NCT02735486|Dietary Supplement|Placebo: Super pure water|Placebo: Super pure water
16020420|NCT02735473|Drug|Choline bitartrate|
16020421|NCT02735473|Drug|Placebo|
16020422|NCT02735460|Device|Andago V2.0|The Andago V2.0 is tested in 2 sessions, the first being a training session to define the probably optimal settings for the subsequent therapy session. In the therapy session the participant performs a specific parcours. Usually this parcours can be done within 10 minutes. However, the session is stopped as soon as the patient feels too exhausted or becomes too weary.
16020423|NCT02735434|Behavioral|Internet-based ACT|The guided internet program consists of 7 modules activated consecutively over a period of 12 weeks. The content is written psycho education, patient videos, audio-exercises and behavioural exposure exercises. The program is therapist-guided; hence all patients will receive support from primarily the same therapist during the 12 weeks.
16020424|NCT02735434|Other|Internet-based discussion forum|The online discussion forum consists of 7 themes touching upon the impact of health anxiety and the patients own coping strategies. The themes are activated consecutively over a period of 12 weeks. The discussion forum is text-based, and only patients will participate in the discussion. The written discussions will be reviewed by a professional for ethical reasons. The discussion forum aims to control for the effect of attention and contacts to the health care system. After 9 months patients in the discussion forum are offered active treatment, but not as part of the research project.
16020425|NCT02735421|Drug|Adapalene 0.3% / BPO 2.5% gel|
16020426|NCT02735421|Drug|Vehicle gel|
16020427|NCT02735408|Other|Kinesiotape (KT)|
16020428|NCT02735395|Procedure|Scaling and root planing (SRP)|SRP performed in four to six appointments lasting approximately 1 h each, using manual curettes (Hu-Friedy, Chicago, IL, USA) and ultrasonic device (Cavitron Select SPC, Dentsply professional, York, PA, USA) under local anesthesia. The deep sites will be scaled throughout the first week and treatment of the entire oral cavity will be completed in 14 days.
16020429|NCT02735395|Drug|Metronidazole 250 (7 days)|Subjects will intake Metronidazole 250 mg. for 7 days, starting immediately after the first session of Scaling and Root Planing.
16020430|NCT02735395|Drug|Metronidazole 400 (7 days)|Subjects will intake Metronidazole 400 mg. for 7 days, starting immediately after the first session of Scaling and Root Planing.
16020431|NCT02735395|Drug|Metronidazole 250 (14 days)|Subjects will intake Metronidazole 250 mg. for 14 days, starting immediately after the first session of Scaling and Root Planing.
16020632|NCT02734056|Other|Music|Listening to music that the patient likes
16020433|NCT02735395|Drug|Amoxicillin|Subjects will intake Amoxicillin 500 mg. for 14 days, starting immediately after and the first session of Scaling and Root Planing.
16020434|NCT02735395|Other|Placebo 250 (7 days)|Subjects will intake placebo of Metronidazole 250 mg. for 7 days, starting immediately after to intake Metronidazole 250 mg.
16020435|NCT02735395|Other|Placebo 400 (7 days)|Subjects will intake placebo of Metronidazole 400 mg. for 7 days, starting immediately after to intake Metronidazole 400 mg.
16020436|NCT02735395|Other|Placebo 400 (14 days)|Subjects will intake placebo of Metronidazole 400 mg. for 14 days, starting immediately after the first session of Scaling and Root Planing.
16020437|NCT02735395|Other|Placebo 500|Subjects will intake placebo of Amoxicillin 500 mg. for 14 days, starting immediately after the first session of Scaling and Root Planing.
16020438|NCT02735382|Behavioral|Tobacco quitline EHR referral|Using an EHR-based referral to the tobacco quitline from primary care outpatient clinics.
16020439|NCT02735382|Behavioral|Tobacco quitline Fax referral|Using an Fax--based referral to the tobacco quitline from primary care outpatient clinics.
16020440|NCT02735369|Drug|2% OC-10X|2% OC-10X
16020441|NCT02735369|Drug|Placebo Comparator|Placebo
16020442|NCT02735356|Drug|Itraconazole|Applied topically
16020443|NCT02735356|Other|Placebo|Applied topically
16020444|NCT02735343|Drug|Compazine|Compazine 10mg with diphenhydramine 25 mg IV
16020445|NCT02735343|Drug|Ketamine|Ketamine 0.3 mg/kg along with ondansetron 4 mg IV
16020446|NCT02735330|Procedure|celiac plexus neurolysis using absolute alcohol|celiac plexus blockade with 40 ml of diluted absolute alcohol(50%) 20 ml on either side of celiac axis in a 4 quadrant fashion
16020447|NCT02735330|Procedure|Placebo celiac plexus injection using saline|Placebo celiac plexus injection with 40 ml of saline 20 ml on either side of celiac axis in a 4 quadrant fashion for blinding
16020448|NCT02735330|Procedure|Frey's procedure|Pancreatic head is partially resected (cored) along with longitudinal opening of duct along its entire length with limit of excavation of the head in the plane of the posterior wall of the Wirsung's duct and duct of Santorini is opened in the uncinate process. All the tissue above the plane, including the duct of Santorini is excised. The reconstruction is done with covering with a loop of jejunum in Roux-en-Y fashion which continues with the main pancreatic duct in the pancreatic body and tail.
16020449|NCT02735317|Drug|Oral Ulcer Gargle (FORRAD®)|Oral Ulcer Gargle (FORRAD®) is prescribed at the beginning of radiotherapy for free. Patients are asked to start application of Oral Ulcer Gargle (FORRAD®) at the onset of radiotherapy, four times a day (after meals and before bedtime), until completion of their radiotherapy. All patients will receive conventional health education and medical care for prevention and treatment of radiation-induced oral mucositis. When grade > 3 OM happened, other interventions, such as prophylactic or therapeutic antibacterial therapy, will be used, and radiotherapy should be interrupted.
16020450|NCT02735317|Drug|Quadruple mixture, composed of dexamethasone, gentamicin, vitamin B12, and procaine|Quadruple mixture is prescribed at the beginning of radiotherapy. Patients are asked to start application of quadruple mixture at the onset of radiotherapy, four times a day (before meals and before bedtime), until completion of their radiotherapy. All patients will receive conventional health education and medical care for prevention and treatment of radiation-induced oral mucositis. When grade > 3 OM happened, other interventions, such as prophylactic or therapeutic antibacterial therapy, will be used, and radiotherapy should be interrupted.
16020451|NCT02735304|Other|Impression intervention|The 1st intervention will compare two clinical impression techniques The Innovation treatment arm will receive the innovation treatment first and then crossover to receive the standard clinical practice treatment. The standard clinical practice treatment will receive the standard clinical practice treatment first and then crossover to receive the innovation treatment.
16020452|NCT02735291|Biological|CD19-targeted CAR-T cells|This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-CD19-modified T cells can recognize and kill tumor cells in the body，follow-up 35 months..
16020453|NCT02735278|Other|different test paradigms|
16020454|NCT02735265|Behavioral|Virtual reality|12 training sessions (90 minutes a time, 2 times a week) IG:45 minute of Kinect for Xbox games and 45 minute of standard treatment.
16020455|NCT02735265|Behavioral|Standard treatment|CG: 90 minute of standard treatment. 12 training sessions (90 minutes a time, 2 times a week)
16020456|NCT02735252|Other|Systemic therapy|Systemic therapy is selected by the physician and is not restricted by the study. Molecular testing will be performed on tissue and blood to identify patterns and relationships with clinical outcomes in each group.
16020457|NCT02735252|Device|StrataNGS|CLIA-approved assay that is being performed as part of standard of care genomic profiling of patients tumor biopsies. The product currently covers about 90 cancer genes and is able to pick up all the known mutations and other types of genetic alterations across them, he added
16020458|NCT02735239|Drug|Durvalumab|
16020459|NCT02735239|Drug|Tremelimumab|
16020460|NCT02735239|Drug|Oxaliplatin|IV administered Chemotherapy
16020461|NCT02735239|Drug|Capecitabine|orally-administered chemotherapy
16020462|NCT02735239|Radiation|Radiotherapy|
16020463|NCT02735239|Drug|Paclitaxel|IV administered Chemotherapy
16020464|NCT02735239|Drug|Carboplatin|IV administered Chemotherapy
16020465|NCT02735239|Drug|5-fluorouracil (5-FU)|IV administered Chemotherapy
16020466|NCT02735239|Drug|Leucovorin|orally-administered chemo-protective agent
16020467|NCT02735239|Drug|docetaxel|IV administered Chemotherapy
16020468|NCT02735226|Other|stroke network and policy intervention|Shanghai stroke service and network contributes to update the ability of stroke care of comprehensive and primary stroke center,to improve radiation ability of comprehensive stroke centers and try to form a close relationship between comprehensive stroke centers and its primary stroke centers.
16020469|NCT02735213|Device|577-MPL|9 spots multispot micropulse mode(without spacing between the spots),160 um spot size, 0.2 second duration, 5% duty cycle(ON time 0.1ms + OFF time 1.9ms), and 250~400 milliWatts of power(50% threshold power),150~200 spots, the laser area is the corresponding leakage on mid-phase FA and around leakage.
16020470|NCT02735213|Device|TLT|contimuous wave,100um spot size, 0.05 seconds duration, 55~60 milliwatts of power, 18~27 spots,the laser area is the corresponding leakage on mid-phase FA.
16020472|NCT02735200|Other|Application of Aloe vera gel|"aloe vera gel will be applied
~Dosage: 1 gram Duration: 120 days Frequency: Daily"
16020473|NCT02735187|Device|Blue light treatment|Phototherapy of localized psoriasis vulgaris plaque with a wearable device emitting blue light at 453nm.
16020474|NCT02735187|Drug|Vitamin D|Treatment of contralateral localized psoriasis vulgaris plaque with Vitamin D creme (Daivonex)
16020475|NCT02735174|Device|Sensor cap system for inhalers|All subjects will be given a commercially available inhaler cap with monitoring sensor on clinically prescribed asthma inhalers.
16020476|NCT02735174|Other|App for SmartPhone|All subjects will be given smart phone with mobile software management platform to motivate and record medication adherence.
16020477|NCT02735174|Behavioral|Motivational interviews|All subjects will have motivational telehealth visits to assess adherence and promote problem-solving skills
16020478|NCT02735174|Other|Telehealth clinic visits|All subjects will have asthma medical visits via telehealth technology to assess asthma control.
16020479|NCT02735161|Other|Muscle strength training|Two different muscle strength training protocols will be compared; one exercise session with high load/low repetitions (4 sets x 5RM) versus one exercise session with low load/high repetitions (2 sets x 25RM). Both session will be conducted at four different exercises; seated leg press, chest press, cable lat pull down and seated rowing.
16020480|NCT02735161|Other|Endurance exercise training|Two different endurance exercise training protocols will be compared; one exercise sessions is interval training with high intensity (85-95% of HRmax) versus one of moderate intensity (70-75% of HRmax) with longer duration.
16020481|NCT02735148|Other|Body Weight Supported Treadmill Training|"There were three intervention arms in this study,
~Body Weight Supported Treadmill Training,
~Conventional Training and
~Combined Training."
16020482|NCT02735135|Device|AIRSOFT DUO for 1 day|The patient is placed on an AIRSOFT DUO mattress for 1 day.
16020483|NCT02735135|Device|SENTRY 1200 for 1 month|The patient is placed on a SENTRY 1200 mattress for 1 month.
16020484|NCT02735135|Device|SENTRY 1200 for 1 day|The patient is placed on a SENTRY 1200 mattress for 1 day.
16020485|NCT02735135|Device|AIRSOFT DUO for 1 month|The patient is placed on an AIRSOFT DUO mattress for 1 month.
16020486|NCT02735122|Drug|acetaminophen Tablet|2 test acetaminophen 500 mg tablets
16020487|NCT02735122|Drug|acetaminophen Caplet|2 commercial acetaminophen 500 mg caplets
16020488|NCT02735122|Drug|ibuprofen Liquid-filled capsule|2 commercial ibuprofen 200 mg Liquid-filled capsules
16020489|NCT02735122|Drug|Placebo Tablet|2 placebo tablets
16020490|NCT02735122|Drug|Placebo Caplet|2 placebo caplets
16020491|NCT02735122|Drug|Placebo Liquid-filled capsule|2 placebo Liquid-filled capsules
16020492|NCT02735109|Other|photographies|cells description by taken photographies vith confocal microscope (VivaScope 3000)
16020493|NCT02735109|Procedure|biopsy normal area|biopsy done to compare with abnormal area
16020494|NCT02735096|Device|EquiCue (Intraoral Electronic Balance Aid)|When the device is worn, a subject will receive small electrical pulses on roof of the mouth as alternative feedback of head tilting or movement.
16020495|NCT02735083|Biological|UCART19 follow-up|UCART19 will not be administered during the study period. Patients who will be rolled-over from the parent study to this long term follow-up study, have previously received UCART19. The roll-over occurs at the end of the parent study, or at any time after UCART19 administration, in case of premature discontinuation from the parent study.
16020496|NCT02735070|Drug|Resfenol|Patients should take the study medication without breaking or chewing together with a cup containing approximately 200 ml of water. The patient should ingest the study drug after fasting for at least 30 minutes.
16020497|NCT02735070|Drug|Coristina d|Patients included in the study will take the drugs 4 times a day, orally. Patients should take the study medication without breaking or chewing together with a cup containing approximately 200 ml of water. The patient should ingest the study drug after fasting for at least 30 minutes.
16020498|NCT02735057|Drug|Carboplatin|
16020499|NCT02735044|Drug|Insulin glargine,300 U/mL|Subcutaneous injection in the morning or evening using a prefilled pen. Dose titration to achieve fasting self-monitored plasma glucose (SMPG) from 90 to 130 milligram/deciliter (mg/dL) (5.0 to 7.2 millimol per liter [mmol/L])
16020500|NCT02735044|Drug|Insulin glargine (100 units /mL)|Subcutaneous injection in the morning or evening using a prefilled pen. Dose titration to achieve fasting SMPG from 90 to 130 mg/dL (5.0 to 7.2 mmol/L)
16020501|NCT02735044|Drug|Background therapy|Fast-acting mealtime insulin analogs
16020502|NCT02735031|Drug|Exenatide|6 weeks treatment with exenatide on top of insulin treatment
16020503|NCT02735031|Drug|Placebo|6 weeks treatment with placebo on top of insulin treatment
16020504|NCT02735018|Drug|Epinephrine 1:100,000|Inferior alveolar nerve block with Epinephrine 1:100.000
16020505|NCT02735018|Drug|Epinephrine 1:200,000|Inferior alveolar nerve block with Epinephrine 1:200.000
16020506|NCT02735005|Other|SMAF assessment|"After written information and non opposition expression, each enrolled patient will be assessed with the Functional Autonomy Measurement System (SMAF) tool during a 1 hour interview.
~The French authority has considered this study as an interventional study with minimal risk because we use a tool (SMAF) that was not developped nor validated in this specific population (disabled people older than 40y). The SMAF assessment is not made in routine in this specific population (ID RCB : 2015-A00642-47)"
16020507|NCT02734992|Behavioral|ACT+ MTAU|Participants will be randomly assigned to one of the two groups: ACT-based intervention, plus their usual health care or Medical Treatment as Usual only (MTAU). The MTAU group will follow their usual medical treatment (prescribed headache medication). Treatment sessions will be conducted weekly by two co-therapists in groups of approximately 8-10 participants for 1 ½ hour. The control group will receive the ACT intervention following the completion of the 3-months follow-up assessment of the treatment group. Participants in both groups will complete primary and secondary outcome scales, as well as ACT process effects scales at pre, post and 3-months follow-up. The treatment group only will be also assessed at 6 and 12-months follow-up. The ACT protocol and the patients' workbook were developed for the needs of the Algea project (Vasiliou & Karekla, 2015). Techniques will focus on key ACT processes aiming at promoting psychological flexibility for the head pain experience.
16020633|NCT02734056|Other|Control|Control
16020668|NCT02733705|Drug|Fentanyl|fentanyl 0.5 mcg/kg ideal BW
16020669|NCT02733705|Drug|propofol|propofol infusion
16020508|NCT02734992|Behavioral|Waitlist Control +MTAU|Participants in the Waitlist control+ MTAU will not receive any active intervention. Upon completion of the 3 months follow-up assessment of the ACT+MTAU group, participants allocated in the Waitlist control+MTAU will receive the ACT intervention.
16020509|NCT02734979|Device|Biobridge and lymph node transfer|Biobridge is surgically implanted with conventional vascularized lymph node transfer surgery
16020510|NCT02734966|Drug|Magnesium Isoglycyrrhizinate Injection 100mg OD|Magnesium Isoglycyrrhizinate Injection 100mg OD
16020511|NCT02734966|Drug|Magnesium Isoglycyrrhizinate Injection 200mg OD|Magnesium Isoglycyrrhizinate Injection 200mg OD for 4 weeks
16020512|NCT02734966|Drug|Tiopronin Injection|Tiopronin Injection 200mg OD
16020513|NCT02734953|Drug|Nitric Oxide|Ambulatory inhaled nitric oxide delivery system and 6 minute walk distance test
16020514|NCT02734940|Drug|Lidocaine|This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.
16020515|NCT02734940|Drug|Unrestricted Fentanyl|No changes to current practices, using unlimited narcotic medications intraoperatively.
16020516|NCT02734940|Drug|Ketamine|This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.
16020517|NCT02734940|Drug|Precedex|This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.
16020518|NCT02734940|Drug|Duramorph|This model would use a combination of intravenous (Dexmedetomidine, Ketamine, Lidocaine) and Spinal (Morphine) drugs.
16020519|NCT02734927|Other|realization of computerized exercises|
16020520|NCT02734914|Device|SF-URS with automatic control of RPP|A new F-URS monitoring and control of RPP using intelligent pressure control device
16020521|NCT02734914|Device|conventional F-URS|Ureteroscopy will be conducted using the ureteral access sheath from Cook Medical to treat renal calculi.
16020522|NCT02734901|Dietary Supplement|400 g frozen raspberries|1x daily intake of 600 mL red raspberry beverage
16020523|NCT02734901|Dietary Supplement|200 g frozen raspberries|1x daily intake of 600 mL red raspberry beverage
16020524|NCT02734901|Dietary Supplement|Placebo|1x daily intake of 600 mL raspberry deprived supplement
16020525|NCT02734888|Other|No drug or device, only a test. The test is called a PET/CT|A single PET/CT scan will be performed
16020526|NCT02734875|Other|Intervention|The intervention arm offers primary care providers additional information on patient risks and benefits as well as an offer of assistance with managing a patient's anticoagulation from a respected service at BWH.
16020527|NCT02734862|Drug|CD101|Intravenous antifungal therapy
16020528|NCT02734862|Drug|Caspofungin|Intravenous antifungal therapy
16020529|NCT02734862|Drug|Fluconazole|oral antifungal therapy
16020530|NCT02734862|Drug|intravenous placebo|normal saline
16020531|NCT02734862|Drug|oral placebo|microcrystalline cellulose
16020532|NCT02734849|Drug|AK001 low dose|25 mg AK001 will be administered as multiple doses
16020533|NCT02734849|Drug|AK001 high dose|250 mg AK001 will be administered as multiple doses
16020534|NCT02734849|Drug|Placebo|Placebo will be administered as multiple doses
16020535|NCT02734836|Device|Balloon Angioplasty|
16020536|NCT02734836|Other|Optical Coherence Tomography|
16020537|NCT02734823|Other|Cytology Specimen Collection Procedure|Undergo collection of serum
16020538|NCT02734823|Other|Laboratory Biomarker Analysis|Correlative studies
16020539|NCT02734823|Other|Questionnaire Administration|Ancillary studies
16020540|NCT02734823|Procedure|Ultrasonography|Undergo transvaginal pelvic ultrasonography
16020541|NCT02734810|Drug|Liprotamase Powder for Oral Solution|Oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement therapy
16020542|NCT02734784|Procedure|Photodynamic Therapy|After a surgical access, the periodontal pockets of teeth selected to receive antimicrobial photodynamic therapy (aPDT) will be irrigated with distilled water. Shortly thereafter, the dye will be applied (phenothiazine hydrochloride- 10mg/mL) from the bottom of the pocket. After 1 minute, irrigation will be performed with distilled water to remove the excess of dye. The stained area will be irradiated with a diode laser (660 nm and a 60 mW/cm²). Six sites per tooth under treatment will be irradiated (10 seconds/ site). Teeth with furcation lesion will increase over 60 seconds into the lesion. Before the application, the supragingival plaque will be removed.
16020543|NCT02734784|Procedure|Sham Photodynamic Therapy|After a surgical access, the periodontal pockets of teeth selected will receive a simulation of antimicrobial photodynamic therapy (aPDT): irrigation with distilled water and simulated laser application. Before the application, the supragingival plaque will be removed.
16020544|NCT02734771|Drug|Brentuximab vedotin|
16020545|NCT02734771|Drug|Rituximab|
16020546|NCT02734771|Drug|Cyclophosphamide|
16020547|NCT02734771|Drug|Doxorubicin|
16020548|NCT02734771|Drug|Prednisone|
16020549|NCT02734745|Device|flash glucose monitoring|Patients will use Freestyle Libre for 14 days at home, during this period they will have to perform at least 7 measurements of capillary blood glucose per day . Patients also will go to our clinical center on two separate occasions , to run a test breakfast. In one of the two occasions it will be specifically induced a moderate initial hyperglycemia and subsequent hypoglycemia . During the test meal and in the subsequent hours for a total of 6 hours , will be carried out frequent blood sampling for measurement of blood glucose using the Yellow Springs glucose analyzer ( YSI system ) , simultaneous measurements with Freestyle Libre and with glucometer.
16020550|NCT02734732|Drug|Trimethoprim/Sulfamethoxazole|
16020551|NCT02734732|Drug|Ciprofloxacin|
16020552|NCT02734719|Device|Bonestim|
16020553|NCT02734706|Dietary Supplement|LRC™ capsule|Twice per day (BID), 9 weeks
16020554|NCT02734706|Other|Placebo capsule|Twice per day (BID), 9 weeks
16020555|NCT02734693|Drug|dasotraline 4mg|dasotraline 4mg/day
16020556|NCT02734693|Other|Placebo|placebo/day
16020557|NCT02734680|Radiation|Concurrent chemoradiotherapy(CCRT)|Radiation and take gemcitabine(GEM)
16020558|NCT02734680|Radiation|Stereotactic Radiotherapy(SBRT)|Stereotactic Radiotherapy(SBRT) (total dose: 45 Gy; single dose: 3 Gy; Frequency:15)
16020559|NCT02734680|Drug|S-1|Taking S-1 orally after radiation
16020560|NCT02734667|Device|CGM at diagnosis of T1D|Initiation of non-adjunctive CGM use at diagnosis of T1D
16020561|NCT02734654|Procedure|remote ischemic preconditioning (RIPC)|Remote ischemic preconditioning: The limb RIPC was applied after the induction of anaesthesia and consisted of 3 cycles: 5 min of ischemia by a cuff-inflator on a thigh and inflated to 200 mmHg, followed by 5 min deflated. The control group had during the same time a deflated cuff on a thigh.
16020562|NCT02734628|Drug|Dexpanthenol (Bepanthen® Wund- und Heilsalbe, BAY81-2996)|30 g of 5% of the active ingredient dexpanthenol plus other ingredients as ointment
16020563|NCT02734628|Drug|Placebo|Placebo to Bepanthen® ointment without active ingredient dexpanthenol
16020564|NCT02734615|Drug|LSZ102|LSZ102
16020565|NCT02734615|Drug|LEE011|LEE011
16020566|NCT02734615|Drug|BYL719|BYL719
16020567|NCT02734602|Drug|Ketamine|Ketamine will be administered after the initial PET scan.
16020568|NCT02734602|Behavioral|Cognitive Testing|Verbal and computer assessments will be given.
16020569|NCT02734602|Radiation|PET|PET scan will involve infusion of a radiotracer.
16020570|NCT02734602|Device|MRI|Anatomical MRIs will be performed on a Siemens 3T Trio at Yale.
16020571|NCT02734589|Other|Fecal transplantation|Transplantation of fecal bacteria from a healthy individual into a recipient- ulcerative colitis patient via colonoscopy and enemas
16020572|NCT02734589|Other|Unique novel Diet for UC and Unique novel Diet for the donor + FMT|A developed unique diet that is geared to induces remission and decreases inflammation in patients with active UC. Also a conditioning diet for healthy subjects to be used by the donor prior to transplantation- a developed unique diet for two weeks.
16020573|NCT02734589|Other|Unique novel Diet for UC|A developed diet that is geared to induces remission and decreases inflammation in patients with active UC.
16020574|NCT02734576|Device|Venous Sinus Stenting with the Precise Pro Stent|Enrolled patients will undergo a minimally invasive procedure that involves placement of a stent in the cerebral venous sinuses (large veins of the brain).
16020575|NCT02734563|Other|Collagen turnover|Type IV and V collagen synthesis and breakdown
16020576|NCT02734550|Other|Standard of care|Patients are treated according to the ESCMID guidelines. Antifungal therapy is started if fungi are detected in the blood culture or other primary sterile body fluids.
16020577|NCT02734550|Other|(1,3)-β-D-glucan guided therapy|Serum for (1,3)-β-D-glucan measurement is obtained after enrollment and 24 hours later. Antifungal therapy is started if at least one sample is 80 pg/ml or higher. If concomitantly taken microbiological cultures remain negative, antifungal therapy is continued only, if both (1,3)-β-D-glucan were at least 80 pg/ml. Blood cultures or other samples from primary sterile body fluids positive for fungi are treated with antifungals irrespective the (1,3)-β-D-glucan results.
16020578|NCT02734537|Drug|Cisplatin|Given IV
16020579|NCT02734537|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16020580|NCT02734537|Other|Laboratory Biomarker Analysis|Correlative studies
16020581|NCT02734524|Biological|NK cells|Natural killer cell infusion is an intervention between two arms. Dosage of infused cell >1×10^9，q28d*4
16020582|NCT02734524|Drug|Taxol|135-175mg/m2,q28d*4
16020583|NCT02734524|Drug|Carboplatin|AUC=5,q28d*4
16020584|NCT02734511|Drug|sedation with propofol|induction with propofol at 20mg/kg/h. Then, when the patient is sleeping, dosage is decreased to 6 mg/kg/h
16020585|NCT02734498|Device|Electroconvulsive Treatment (ECT) Right Unilateral|Intervention is electroconvulsive treatment (ECT) involves a brief electrical stimulation of the brain while the patient is under anesthesia. Performed unilateral on the right side.
16020586|NCT02734498|Device|Electroconvulsive Treatment (ECT) - Bilateral|Intervention is electroconvulsive treatment (ECT) involves a brief electrical stimulation of the brain while the patient is under anesthesia. Performed Bilateral.
16020587|NCT02734485|Device|active Deep TMS|"The Brainsway DTMS produces a time-varying magnetic field and, based on Faraday's Law, it can be assumed that a time-varying magnetic field generates an electrical current in a nearby conductive substance. The induced electric current in the cortex travels in an orthogonal path in the direction of the magnetic field with the maximum strength and current located beneath the coil in the helmet placed on the patient's head and transmits magnetic pulses to the patient's brain. The induced current is tangential to the scalp at the cortical surface, and decreases in magnitude with increasing depth.
~Patients underwent 12 sessions, 3 times a week, of repetitive DTMS using the novel H2-coil (Brainsway LDT)."
16020588|NCT02734485|Device|sham Deep TMS|The Sham DTMS consisted in the same protocol of active treatment with the same preparation of the subject and settings of the instrument but with an INACTIVE DTMS coil.
16020589|NCT02734472|Other|Incidence and risk factors of hypertension|During the follow-up period,General information(age, sex, BMI, blood pressure, the history of drink and smoke, medical history, etc).Blood biochemistry parameters（Lipid, hsCRP levels, etc）and other laboratory examination parameters(arterial stiffness,IMT, FMD) will be collected.
16020590|NCT02734459|Drug|cataract surgery|"the patient will be dosed with the study drug into the V pocket is formed between the eye ball and the lower eyelid during cataract surgery."
16020591|NCT02734446|Drug|Reuterin D3 drops|5 drops/day for 3 months
16020592|NCT02734446|Other|Placebo|5 drops/day for 3 months
16020593|NCT02734433|Drug|Pexidartinib|
16020594|NCT02734420|Drug|PapacarieMBlue and PDT|Initial periapical and interproximal radiographs Microbiological sample with otoscope curette to standardize volume of carious tissue; Application on PapacarieMBlue (addition of toluidine blue) for 5 minutes to potentiate effect of PDT; Removal of carious tissue around lateral walls of the cavity with non-cutting curette; No removal of carious tissue on pulp floor; Irradiation of dental tissue for one minute on a single point; Second microbiological sample of remaining dentin with curette; Clinical evaluation by inspection of texture of remaining dentin with exploratory probe; Restoration with glass ionomer cement (Ketac Molar EasyMIx 3M ESPE); Follow up;Radiographic control: periapical and interproximal radiographs at 3, 6 and 12 months.
16020634|NCT02734017|Other|pharmacist-led standardized medication review|the goal of this study is to assess the impact of the standardized medication review on the rate of readmissions and/or death at 30 days following initial hospitalization discharge.
16020716|NCT02733354|Device|watch viedo|
16020717|NCT02733341|Drug|Cangrelor|
16020718|NCT02733341|Drug|Ticagrelor|
16020719|NCT02733328|Procedure|CPB Surgery|
16020595|NCT02734420|Drug|Toluidine Blue O and PDT|Initial periapical and interproximal radiographs;Microbiological sample with otoscope curette to standardize volume of carious tissue;Application of Toluidine Blue O for 5 minutes to potentiate effect of PDT; Removal of carious tissue around lateral walls of the cavity with sharp curette; No removal of carious tissue on pulp floor;non-cutting curette; Irradiation of dental tissue for one minute on a single point;Second microbiological sample of remaining dentin with curette;Clinical evaluation by inspection of texture of remaining dentin with exploratory probe; Restoration with glass ionomer cement (Ketac Molar EasyMIx 3M ESPE);Follow up;Radiographic control: periapical and interproximal radiographs at 3, 6 and 12 months.
16020596|NCT02734420|Device|Laser|
16020597|NCT02734407|Procedure|Assigned Intervention|All subjects receiving PRN IVT aflibercept injections will be evaluated for focal laser treatment beginning at week 12 through the end of the study as assigned intervention. If the subject meets any of the criteria for focal laser treatment (FLT), fluorescein angiography (FA) will be performed to guide the focal laser treatment. Focal laser treatment and focal laser re-treatment will be administered no more than once every 90 days.
16020598|NCT02734407|Drug|aflibercept 2.0 mg|If a subject has recurrent CR-DME they will receive an IVT aflibercept injection
16020599|NCT02734394|Behavioral|Exercise|Cardiovascular and resistance exercise training
16020600|NCT02734381|Other|Elderly patients|Elderly patients who visited the Emergency Department
16020601|NCT02734368|Drug|Hyperpolarized Helium-3|
16020602|NCT02734355|Drug|Telmisartan 80 mg and amlodipine 5 mg|
16020603|NCT02734355|Drug|Placebo (for telmisartan and amlodipine)|Sugar pill manufactured to mimic telmisartan 80 mg and amlodipine 5 mg tablet
16020604|NCT02734342|Other|exercise|Participants will be asked to attend eight exercise sessions within a group class environment that will last for 1 hour. The exercise programme has been developed through clinical and research evidence. During the hour, a 5 minute warm up followed by 14 exercises specific to strengthening the lower limb and improving aerobic capacity. Each exercise will be timed for two minutes with the participant reporting number of repetitions counted. A cool down will be completed at the end of the class. After each exercise class, the participant will be advised to have a recovery day to prevent overloading (De Carlo & Armstrong, 2010). Progression of exercises will be patient led. Participants will attend twice per week for four weeks.
16020605|NCT02734329|Procedure|conventional laparoscopic partial nephrectomy|renal artery will be clamped during surgery.
16020606|NCT02734329|Procedure|zero ischemia laparoscopic RFA/MVA assisted tumor enucleation (TE)|
16020607|NCT02734316|Other|endoscopic procedure|Evaluation of adverse events in patients on DOACs undergoing GI endoscopy
16020608|NCT02734290|Drug|Pembrolizumab|Pembrolizumab 200mg every 3 weeks by IV infusion on Day 1 of each 3 week cycle
16020609|NCT02734290|Drug|Paclitaxel|Paclitaxel 80mg/m2 every 3 weeks by IV infusion on Days 1, 8, and 15 of each 3 week cycle
16020610|NCT02734290|Drug|Capecitabine|Capecitabine 2000mg every two weeks by mouth twice each day on days 1-7 of each 2 week cycle.
16020611|NCT02734251|Dietary Supplement|Relora|750 mg/day
16020612|NCT02734251|Dietary Supplement|Placebo|
16020613|NCT02734238|Drug|Sesame Oil|200 mg sesame oil by intramuscular injection weekly on days 15, 21, 28, and 35
16020614|NCT02734238|Drug|testosterone enanthate|200 mg testosterone enanthate by intramuscular injection weekly on days 15, 21, 28, and 35
16020615|NCT02734225|Other|Functional Recovery|Rehabilitation protocol based on muscle strengthening with isometric, isotonic and counter-resistance with progressive load exercises. Intervention consisted of warm-up phase with passive, active-assisted and active movements, and a work-out phase
16020616|NCT02734225|Other|Balance Training|Balance and proprioception training using parallel bars, unstable plates, ramps and stairs
16020617|NCT02734225|Other|Dynamometric Platform Training|Stability tests, weight changes and stability limits, performing both anterior-posterior and medial-lateral movements simultaneously in some cases
16020618|NCT02734212|Behavioral|Ending Self Stigma for PTSD|Ending Self Stigma for PTSD (ESS-P) is a 9-session small-group (6-8 persons) course designed to help individuals with PTSD develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
16020619|NCT02734212|Other|Enhanced Treatment as Usual|The comparison condition will consist of providing a pamphlet that discusses societal stigma and internalized stigma, and provides resources to help combat the effects of both. Participants will be given the informational pamphlet and study staff will discuss its content with the participant.
16020620|NCT02734186|Drug|Praziquantel|Anthelminthic
16020621|NCT02734173|Drug|ABT450r-ABT267-ABT333 +/- Ribavirin|12 week duration of HCV antiviral therapy with ABT450r-ABT267-ABT333 +/- Ribavirin
16020622|NCT02734160|Drug|Galunisertib|Administered orally
16020623|NCT02734160|Drug|Durvalumab|Administered IV
16020624|NCT02734147|Drug|Ascorbic Acid|
16020625|NCT02734147|Other|Normal Saline|
16020626|NCT02734134|Procedure|One-stage exchange joint replacement surgery|
16020627|NCT02734134|Procedure|Two-stage exchange joint replacement surgery|
16020628|NCT02734121|Behavioral|pre-consultation educational group intervention|"Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.
~Surgeon (40 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities
~Registered nurse (20 mins): preparing for surgery, postoperative recovery and how to navigate the health care system
~Social worker (30 mins): values clarification exercise
~Breast reconstruction patient volunteers (30 mins) questions and answers about their personal experience"
16020629|NCT02734108|Device|Transcranial direct current stimulation|Anodal transcranial direct current stimulation over the dorsolateral prefrontal cortex
16020630|NCT02734095|Device|Ultrasound|Intravascular ultrasound measurements after percutaneous transluminal angioplasty and stenting in the treatment of femoropopliteal lesions.
16020631|NCT02734069|Drug|Carboplatin|Patients will receive carboplatin according to the carboplatin area under the curve dose calculation for 2 cycles to evaluate toxicity.
16089742|NCT02238535|Drug|Warfarin|
16020638|NCT02733991|Device|MiniMed™640G and Suspend before low|"All enrolled subjects will start a run in phase, receive training and start pump therapy with the MiniMed™640G insulin pump and usage of blinded Continuous Glucose Monitoring. Eligible subjects that meet the randomization criteria assessed after the running phase will be randomized into the treatment or control arm. Treatment Arm: training and start of Sensor Augmented Pump therapy with Suspend before Low feature of SmartGuard turned ON.
~Control Arm: continuation of pump therapy alone with blinded continuous glucose monitoring for a total of 6 weeks during the treatment phase."
16020639|NCT02733991|Device|MiniMed™640G|Control Arm: continuation of pump therapy alone with blinded continuous glucose monitoring for a total of 6 weeks.
16020640|NCT02733978|Device|the ozone generator device (Human Pro medic, German)|noninvasive oxygen-ozone treatments with 52 ug/mL ozone (total volume: 20-50 mL) in a special bag for 30 min per day for 20 days using the ozone generator device (Human Pro Medic, German)
16020641|NCT02733965|Other|Pharmaceutical Consultations|"The first part of the pharmaceutical consultation focuses on a complete clinical medication review, the effective use of drugs will be discussed with the patient.
~Study of health behaviors Concerning self-medication and alternative medicine Addictions Drug adherence List and grade (NCI version 4) of clinical signs and laboratory abnormalities The biological data will be obtained Clinical signs will be obtained from patient questioning The second part of the consultation is to achieve firstly a pharmaco-therapeutic analysis of the treatment in order to detect problems with drugs as classified by the French Society of Clinical Pharmacy The third step consists on providing pharmaceutical interventions following the pharmaco-therapeutic analysis (18).
~These pharmaceutical interventions might concern the prescribers, the other caregivers, or the patient himself. T"
16020642|NCT02733965|Other|No Pharmaceutical Consultations|
16020643|NCT02733952|Drug|Tranexamic Acid|
16020644|NCT02733952|Procedure|Pericervical Tourniquet|
16020645|NCT02733939|Device|Home monitoring kit|"The home monitoring kits notify the caregivers about potentially dangerous situations, such as when the person with dementia:
~leaves the home without notice, since this might occur in a moment of disorientation;
~leaves a water tap open;
~forgets something on the stove;
~gets out of bed during the night and doesn't come back within a certain time interval;
~never goes to the bathroom in 24 hours;
~never opens refrigerator door in 24 hours.
~Depending on the personal choice of the study participants, the kit will also :
~automatically turn on a light to help avoid a fall during the night;
~alert the caregiver when the temperature in the house falls or rises excessively;
~act as burglar alarm in some areas of the home."
16020646|NCT02733926|Other|Adding of vegetation into the backyards of kindergarten|Living plants are transferred into the backyards of kindergartens. This is assumed to affect the measured variables of children.
16020647|NCT02733900|Procedure|femoral head removal|
16020648|NCT02733887|Device|magnetic resonance imaging|MRI was performed on a 3 Tesla system (GE Discovery 750W). A single-shot,echo-planar imaging-based, spectral adiabatic inversion recovery DWI sequence was obtained with b values of 0,30,50,80,100,150,200,400,600,800 and 1,000.
16020649|NCT02733887|Device|positron emission tomography/computed tomography|18F-FDG-PET/CT was performed using a multidetector PET/CT system (GE Discovery ST16). Patients fasted for 6 hours before imaging.
16020650|NCT02733887|Radiation|fludeoxyglucose F 18|Patients fasted for 6 h before receiving FDG intravenously. A dose of 5.18-7.4 MBq/kg was used.
16020651|NCT02733874|Drug|Compound Clobetasol Propionate Ointment|
16020652|NCT02733874|Drug|Calcipotriol Betamethasone Ointment|
16020653|NCT02733848|Drug|Creon|"Creon is a porcine derived pancreatic enzyme supplement that comes in in fixed dose combinations of lipase, protease, and amylase, respectively. Dosing is based on lipase per kilograms per meal (i.e. lipase units/kg/meal). Subjects will be started at a dose of 500 units of lipase/kg/meal and snacks at week 4 and continued until week 8. A follow-up visit at week 6 will assess patient for tolerance to Creon and need for dosage adjustment.
~Formulations come in different fixed dose combinations as follows:
~Creon: Lipase 3000 USP units, protease 9500 USP units, and amylase 15,000 USP units
~Creon: Lipase 6000 USP units, protease 19,000 USP units, and amylase 30,000 USP units
~Creon: Lipase 12,000 USP units, protease 38,000 USP units, and amylase 60,000 USP units
~Creon: Lipase 24,000 USP units, protease 76,000 USP units, and amylase 120,000 USP units
~Creon: Lipase 36,000 USP units, protease 114,000 USP units, and amylase 180,000 USP units"
16020654|NCT02733848|Other|Diet|A registered dietician will meet with the subject and take a thorough review of the patient's dietary history. The subject will then be counseled on a lower carbohydrate and higher protein diet. This diet will be continued for the entire 12 week of the study. The registered dietician will reinforce dietary recommendations by phone on week 2, 4 and 8, respectively.
16020655|NCT02733848|Other|Placebo|Placebo will be given to the patient in single blind fashion with the subject unaware but PI aware of study drug assignment from week 8-12. Placebo tablets will be given with meals and snacks similar to CREON to maintain patient blinding to study drug assignment. A follow-up visit on week 10 to review patient tolerance, side effects and possible drug adjustment.
16020656|NCT02733835|Drug|Remifentanil|Vital signs-controlled, patient assisted intravenous analgesia using remifentanil
16020657|NCT02733822|Drug|Naloxone|
16020658|NCT02733809|Drug|Sorafenib|Liver lesion biopsy (HCC) and blood samples will be taken from the subjects before starting the treatment course, and another biopsy and blood samples when they devolve a resistance.
16020659|NCT02733783|Device|Cold dry air machine|Cold Dry Air (CDA)- nasal provocation: Compressed dry air is delivered through a transparent anaesthesia mask placed over the nose and mouth of the patients. Subjects are instructed to breath through the nose only. Exposure to CDA lasts for 15 minutes. The flow, measured by a gas flow analyzer of Dräger was set at 12,5 l/min. The temperature of the air reaching the nose is at -10° C with a relative humidity of 10%-15%.
16020660|NCT02733770|Procedure|Laparoscopic sleeve gastrectomy|Doppler ultrasound.
16020661|NCT02733770|Procedure|Laparoscopic mini gastric bypass|Doppler ultrasound.
16020662|NCT02733757|Drug|Clonidine|Clonidine 1 µg/kg plus 2% lidocaine
16020663|NCT02733744|Biological|Fecal Microbiota Transplantation (FMT)|FMT will be given through the ingestion of 30 capsules (15 capsules daily x 2 consecutive days)
16020664|NCT02733731|Drug|Chinese Herbal Compound Ointment|
16020665|NCT02733731|Drug|Estriol|
16020666|NCT02733718|Device|NIRS (near-infrared spectroscopy)|mesenteric oxygenisation measurement
16020667|NCT02733705|Other|Control|normal saline IV
16089743|NCT02238522|Drug|ZEN003365|
16020670|NCT02733692|Behavioral|Understanding Reproductive Health for Ladeez (GURHL) Code|Understanding Reproductive Health for Ladeez (GURHL) Code is an acceptability study to test a web-based application designed with and for young women of color 18 to 25 years old.
16020671|NCT02733679|Drug|Metformin|Metformin will be given orally, regularly for eight weeks. Dose starts at 500mg once daily for one week, increasing by 500mg per week, to final dose of 1000mg twice daily.
16020672|NCT02733679|Drug|Pioglitazone|Pioglitazone will be given orally, regularly for eight weeks. Dose starts at 15mg once daily and after one week increases to 30mg once daily.
16020673|NCT02733666|Procedure|Absorbable screw group|Open reduction was performed and one absorbable screw was used for fixation in the experimental group
16020674|NCT02733653|Device|Jetstream Atherectomy System|A rotating, aspirating, expandable catheter system for active removal of atherosclerotic debris and thrombus in the SFA and/or PPA
16020675|NCT02733640|Drug|Pantoprazole|pantoprazole 40 mg once-daily
16020676|NCT02733640|Drug|Ranitidine|ranitidine 150 mg twice-daily
16020677|NCT02733627|Drug|BI 1467335|
16020678|NCT02733627|Drug|Placebo|
16020679|NCT02733614|Drug|SRX246|novel V1a receptor antagonist
16020680|NCT02733614|Drug|Placebo|matching placebo
16020681|NCT02733601|Other|NIS (Non Interventional Study) observational study|NIS observational study : Epidemiologic registry
16020682|NCT02733588|Drug|G-Pump™ (glucagon infusion)|0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump
16020683|NCT02733575|Other|Compassion Focused Therapy|Up to 26 sessions of Compassion Focused Therapy
16020684|NCT02733549|Other|LFTs|"A single 5-ml peripheral venous blood sample was collected from each participant.
~Serum ALT, AST, ALP, GGT, total bilirubin, conjugated bilirubin, and albumin level, Platelet count, INR and aPTT were analyzed."
16020685|NCT02733536|Device|Standard endotracheal tube|1) Direct laryngoscopy using a Macintosh laryngoscope with size 3 blade (Mercury Medical, Clearwater, FL, USA) with a conventional 7.0 mm internal diameter (ID) tracheal tube
16020686|NCT02733536|Device|C-MAC|C-MAC introduced with a h size 3 blade.
16020687|NCT02733523|Behavioral|"Program Sentirnos bien (Feeling well)"|"Group-based intervention delivered face-to face and held once a week during 3 months. It comprises:
~Promoting the uptake of self-care healthy habits: providing information, setting personal goals and sharing experiences to facilitate behavioural change, specially on physical activity and healthy dietary habits.
~Promoting social capital at individual level: facilitating mutual knowledge and mutual support among participants and fostering participation in sociocultural and community activities in the neighbourhood through visits to the community assets accompanied by volunteers.
~Promoting health literacy: improving navigation through the health care system, communication with health professionals, as well as the understanding and decision making when buying food."
16020688|NCT02733510|Drug|methylprednisolone|Steroid pulse therapy : Methylprednisolone 0.5 g daily for 3 days, followed by a tapered dose of 60 mg per day for a period of five days.
16020689|NCT02733497|Procedure|Sympathectomy|Resection of ganglia at T3 level
16020690|NCT02733497|Procedure|Sympathicotomy|Cutting of symptahetic chain at T3 level without ganglia excision
16020691|NCT02733484|Dietary Supplement|Probiotics|the patients in this arm will receive probiotics with a dose for 2g/d for 3 months.
16020692|NCT02733484|Dietary Supplement|Placebo|the patients in this arm will receive placebo intervention
16020693|NCT02733471|Drug|Lidocaine|
16020694|NCT02733471|Drug|Placebo|Placebo
16020695|NCT02733458|Drug|GELAD|Gemcitabine, 1.0g/m2/d IV, day 1 Etoposide, 60mg/m2 IV, day 1 to day 3 Dexamethasone, 40mg/d IV, day 1 to day 4 Pegaspargase, 2000IU/m2/d IM, day 4
16020696|NCT02733458|Radiation|Radiotherapy|Radiotherapy: 50-56Gy
16020697|NCT02733445|Drug|dasatinib|
16020698|NCT02733445|Drug|nilotinib|
16020699|NCT02733432|Drug|CD101 Vaginal Gel (3%)|CD101 Vaginal Gel (3%) intravaginally applied topical gel on Days 1 and 2
16020700|NCT02733432|Drug|CD101 External gel (1%)|CD101 external gel (1%) applied topically twice daily over 72 hours as needed
16020701|NCT02733432|Drug|CD101 Vaginal Ointment (6%)|CD101 vaginal ointment (6%) intravaginally applied topical ointment on Day 1
16020702|NCT02733432|Drug|CD101 External ointment (1%)|CD101 external ointment (1%) applied topically twice daily over 72 hours as needed
16020703|NCT02733432|Drug|Fluconazole|oral fluconazole (150mg) on Day 1
16020704|NCT02733419|Drug|Enfuvirtide|Participants will receive 90 mg enfuvirtide subcutaneously (SC) b.i.d.
16020705|NCT02733419|Drug|Optimized background antiretroviral regimen (OB)|Participants will receive OB (nucleoside and or non-nucleoside reverse transcriptase inhibitor and protease inhibitor) as per investigator's discretion. Protocol does not specify any particular OB drugs.
16020706|NCT02733406|Other|Target Controlled Infusion|
16020707|NCT02733406|Other|Velocity Controlled Infusion|
16020708|NCT02733393|Procedure|Sphenopalatine Ganglion (SPG) Block|Patients who are undergoing a thoracotomy will be informed that they may develop moderate to severe postoperative ISP and may have the option to receive an SPG block. The SPG block will be performed every three minutes for 20 minutes, 0.1mL of the 4% lidocaine will be administered through. After 20 minutes and various intervals thereafter the patient will be asked to rate their shoulder pain.
16020709|NCT02733393|Drug|lidocaine|
16020710|NCT02733380|Drug|Chidamide|30mg , Oral twice a week(with an interval of no less than 3 days,;e.g. Monday and Thursday，Tuesday and Friday) until disease progression or unacceptable toxicity develops
16020711|NCT02733380|Drug|Vinorelbine|20mg/m2， IV on day 1 of each 14 day cycle until disease progression or unacceptable toxicity develops, up to 12 cycles
16020712|NCT02733380|Drug|Liposomal Doxorubicin or mitoxantrone|20mg/m2, IV on day 1 of each 14 day cycle（Note：for patients who can not afford the liposomal doxorubicin，may be replaced into mitoxantrone 8mg/m2, IV on day1 of each 14 day cycle） until disease progression or unacceptable toxicity develops, up to 12 cycles
16020713|NCT02733380|Drug|Dexamethasone|10mg/m2 , IV on day 1-5 of each 14 day cycle until disease progression or unacceptable toxicity develops, up to 12 cycles
16020714|NCT02733380|Drug|Thalidomide|100mg,Oral at night on each day until disease progression or unacceptable toxicity develops, up to 24 weeks
16020715|NCT02733367|Drug|Infacort®|Infacort® is a dry granule formulation of hydrocortisone stored in capsules available in different strengths (0.5, 1.0, 2.0 and 5.0 mg).
16020720|NCT02733315|Behavioral|Diabetes Conversation Map Program|"The experiment group received seven DCMP-based group education sessions for seven consecutive weeks in addition to routine health education at a private room in the outpatient unit. One registered nurse who received DCMP facilitator training, from the Taiwanese Association of Diabetic Educators, served as the class facilitator. DCMP sessions were conducted using seven colored maps covering different topics, including walk with diabetes, what is diabetes?, a healthy diet and exercise, walk with insulin, diabetes complications and related risk factors, foot care for diabetes patients, and a type 1 diabetes patient in the home. Each map, a laminated 3-by-5-foot table-top visual with colorful drawings as metaphors of situations familiar to DM patients, was placed on a table with participants gathered around it. This procedure served to create mutual imagery to be shared with participants."
16020721|NCT02733302|Behavioral|Hope theory|Adapted Physical Activity
16020722|NCT02733276|Other|electroacupuncture|Electroacupuncture: Using an electroacupuntor with different frequencies during 20 minutes. Needles are connected to the electrodes.
16020723|NCT02733276|Other|Sham: Electroacupuncture sham|Sham comparator (Electroacupuncture sham): Using an electroacupuntor with different frequencies during 20 minutes. Needles are connected to the electrodes.
16020724|NCT02733263|Dietary Supplement|15 g RMD|15 grams of resistant maltodextrin
16020725|NCT02733263|Dietary Supplement|25 g RMD|25 grams of resistant maltodextrin
16020726|NCT02733263|Dietary Supplement|0 g RMD|0 grams of resistant maltodextrin
16020727|NCT02733250|Biological|Pembrolizumab|200mg IV Day 1 of each 21 cycles
16020728|NCT02733250|Drug|Nab-Paclitaxel|100mg/m2 IV Day 1, 8 and 15 of every 21 day cycles
16020729|NCT02733237|Drug|oxytocin treatment|intranasal administration of oxytocin (40 IU)
16020730|NCT02733237|Drug|placebo treatment|intranasal administration of placebo (40 IU)
16020731|NCT02733211|Device|MD- Logic Closed Loop System|Closed Loop System
16020732|NCT02733211|Device|sensor augmented pump therapy|Sensor augmented pump therapy
16020733|NCT02733198|Other|Prognosis-guided therapy|
16020734|NCT02733185|Drug|disodium EDTA|
16020735|NCT02733185|Dietary Supplement|Oral Multi Vitamins/Minerals (OMVM)|
16020736|NCT02733185|Drug|Placebo disodium EDTA|
16020737|NCT02733185|Dietary Supplement|Placebo Oral Multi Vitamins/Minerals (OMVM)|
16020738|NCT02733159|Drug|pembrolizumab|anti PD-1
16020739|NCT02733146|Other|cardiac arrest|
16020740|NCT02733133|Drug|Testagen® TDS Testosterone 5% HypoSpray®|Topically applied Testosterone Hormone Replacement Lotion
16020741|NCT02733120|Other|stable isotope infusion|stable isotopes such as 15N2, TRP, 2H3-Leucine, L-[2H3]-3-Methylhistidine, 2H2-Glycine, 2-D-hydroxyproline, 1-13C-ketoisocaproic acid (KIC), L-[Guanido-15N2]-Arginine, L-[ureido-13C-2H2]-Citrulline), L-Glutamine-amide-15N, 1,2-13C2-L-Glutamic acid, 1,2-13C2Taurine, and 13C-Urea is given IV simultaneously
16020742|NCT02733107|Drug|Apatinib|Apatinib, 250mg daily, po, continue until disease progression
16020743|NCT02733107|Drug|Etoposide|Etoposide, 50mg daily, po, day 1 to day 20, repeat Q 4 weeks until disease progression
16020744|NCT02733094|Drug|Secukinumab|
16020745|NCT02733081|Procedure|Simplified IUD Insertion|IUD Insertion with no bimanual pelvic exam or uterine sounding.
16020746|NCT02733068|Biological|HPV-16/18 vaccine|0.5ml of recombinant human papillomavirus virus-like particle vaccine (Type 16 and 18 L1 Proteins, Yeast) on upper arm deltoid muscle with a three-dose-schedule (0, 2, 6 months).
16020747|NCT02733068|Biological|HPV-16/18 placebo|0.5ml of placebo on upper arm deltoid muscle with a three-dose-schedule (0, 2, 6 months).
16020748|NCT02733055|Other|posturographic evaluation|subjects will undergo CDP testing using one of the ext_mCTSIB tests without (baseline) and with oculomotor task
16020749|NCT02733042|Drug|Durvalumab|Administered as an IV infusion (250 mL) over approximately 1 hour in duration
16020750|NCT02733042|Drug|Lenalidomide|Administered orally
16020751|NCT02733042|Drug|Rituximab|Administered by intravenous infusion
16020752|NCT02733042|Drug|Ibrutinib|Administered orally
16020753|NCT02733042|Drug|Bendamustine|Administered as a 30-minute intravenous infusion
16020754|NCT02733029|Drug|Sonazoid|Sonazoid (GE Healthcare) is a contrast agent that is a lipid-stabilized suspension of perfluorobutane microbubbles
16020755|NCT02733029|Device|contrast enhanced ultrasonography|Injection of intravenous ultrasound contrast
16020756|NCT02733003|Behavioral|Women's Health CoOp (WHC)|Participants in this group will participate in two workshops of the woman-focused intervention about HIV/STIs, sexual behaviors, alcohol and other drug use, violence, communication skills, and other issues.
16020757|NCT02732990|Behavioral|Exercise training|All gruoups will undergo 6 weeks of training intervention either with a small musclemass (one-legged exercise) or whole body exercise (two-legged cycling)
16020758|NCT02732977|Other|expert system development|data collection (imaging, biology physiology ... ) of patients with systolic heart failure complicated by mitral regurgitation and / or cardiac synchronization before and after implementation of the recommended standard treatments and modeling using mathematical and statistical models fed all data .
16020759|NCT02732964|Other|Pandora Music|Patients enrolled will be exposed to Pandora music for 30 minutes prior to their spinal anesthesia and cesarean delivery, and throughout their surgery.
16020760|NCT02732964|Other|Mozart Music|Patients enrolled will be exposed to Mozart music for 30 minutes prior to their spinal anesthesia and cesarean delivery, and throughout their surgery.
16020761|NCT02732951|Drug|BI 1026706|
16020762|NCT02732951|Drug|Placebo|
16020763|NCT02732938|Drug|PF-04136309|PF-04136309 oral dosing
16020764|NCT02732938|Drug|Nab-paclitaxel|Nab-paclitaxel IV dosing
16020765|NCT02732938|Drug|Gemcitabine|Gemcitabine IV dosing
16020766|NCT02732925|Device|Arm 2 Balloon Kyphoplasty|"Arm 2 Balloon Kyphoplasty (Medtronic LCC) and Conservative Treatment
~Subjects will be blinded and randomised to Arm 2 and will undergo a general anaesthetic and undergo a balloon kyphoplasty surgical procedure. They will also be treated with conservative management.
~Below is a list of the conservative management they will be managed by their Doctor:
~Bisphosphonates
~Pain relief
~Systemic chemotherapy for Myeloma disease
~Bed rest
~Radiotherapy
~Physiotherapy"
16020851|NCT02732262|Drug|Oxycodone, 0.03 mg/kg dose|Intravenous oxycodone is provided as patientcontrolled analgesia after surgery with bolus dose of 0.03 mg/kg.
16020767|NCT02732925|Procedure|Conservative Management|"Patients recruited to Arm 1 and Arm 2 will undergo conservative management for Multiple Myeloma recommended by their Consultant Hematologist.
~Concomitant treatment with bisphosphonates
~Pain relief as required
~Systemic chemotherapy for Myeloma disease
~Bed rest
~Radiotherapy
~Physiotherapy"
16020768|NCT02732912|Device|Ear plugs|The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep.
16020769|NCT02732912|Device|Eye Mask|The patient will be given a plastic wallet containing an eye mask and ear plugs, to be used when trying to sleep.
16020770|NCT02732912|Drug|Zopiclone|This night sedation will be given to any patient requesting it, in either group
16020771|NCT02732899|Drug|Sirolimus|
16020772|NCT02732899|Drug|EYLEA|
16020773|NCT02732886|Device|Medifoam®|Foam Dressing
16020774|NCT02732886|Device|Betafoam®|Foam dressing including Betadine iodine
16020775|NCT02732873|Device|FibroFix Meniscal Scaffold|FibroFix™ Meniscus scaffold is a silk derived product developed to functionally replace the excised unstable meniscus following a meniscal tear.
16020776|NCT02732860|Other|Molecular Profiling & In Vivo drug testing in pPDX and organoid cultures|Molecular profiling of host tumour sample and pPDX will be performed and analyzed by an expert panel. In vitro organoid culture generation may also be performed if sufficient fresh tissue is available. Matched treatment recommendation based on profiling and in vivo pPDX drug testing results will be made, if available. This recommendation will be communicated to the primary oncologist.
16020777|NCT02732847|Other|A delayed prescription dated 2 days after clinical office visit|
16020778|NCT02732847|Drug|Usual Dated|
16020779|NCT02732834|Behavioral|Questionnaire|patients will fill out a questionnaire about their perceived stigma, satisfaction with communication, and psychological distress.
16020780|NCT02732834|Behavioral|Patient Interview|Then they will participate in a brief in-person interview about their perceived stigma during the clinical consultation
16020781|NCT02732834|Behavioral|Audio recordings of clinical consultations|
16020782|NCT02732834|Behavioral|Questionnaire|Patients will fill out a questionnaire about their perceived stigma and satisfaction with their clinician's communication.
16020783|NCT02732834|Behavioral|2-hour empathic communication skills training|2-hour empathic communication skills training
16020784|NCT02732834|Behavioral|Standardized Patient Assessments|pre-training SPA, post-training SPA
16020785|NCT02732834|Behavioral|Training evaluation|Clinicians will complete an evaluation assessing the empathic communication training module.
16020786|NCT02732834|Behavioral|Patient recruitment|6 of the clinician's patients (3 pre-training, 3 post-training) will be recruited to complete brief surveys assessing clinician communication
16020787|NCT02732821|Procedure|Gastric Per Oral Endoscopic Myotomy|Patients will receive Per Oral Endoscopic Gastric Myotomy for Gastroparesis.
16020788|NCT02732808|Drug|Ovulation stimulation|"Double stimulation in 2 phases:
~Phase I: Clomiphene citrate (Ovumid®) 25 mg/day with co-treatment of Letrozole (Letrofem®) 2.5 mg/day are given from cycle day 3 onwards. Letrozole (Letrofem®) 2.5 mg/day are given from cycle day 3 onwards. human menopausal gonadotrophin (HMG) Menopur®150 IU every other day beginning on cycle day 6. triptorelin (Decapeptyl®) 100 μg follows by ibuprofen 600 mg.
~Phase 2:A total of 225 IU HMG(Decapeptyl®) and letrozole (Letrofem®) 2.5 mg is administered daily .Daily administration of medroxyprogesterone acetate (Progestrone®)10 mg. . the final stage of oocyte maturation is induced again with triptorelin (Decapeptyl®)100 μg by injection."
16020789|NCT02732795|Other|Morphine pharmacokinetic evaluation|Each group received morphine and blood drawn to evaluate morphine PK
16020790|NCT02732782|Other|Isometric exercise|
16020791|NCT02732782|Other|Eccentric exercise|
16020792|NCT02732769|Device|GammaKnifePerfexion®|neurosurgery
16020793|NCT02732769|Device|GammaKnifeIcon®|neurosurgery
16020794|NCT02732769|Device|Efficast®|Thermoformed mask
16020795|NCT02732769|Device|MRI|
16020796|NCT02732756|Behavioral|Healthy Sleep Duration|This study examines healthy sleep duration as related to improved functioning in adolescents with ADHD. Adolescent participants will be instructed to go to bed at a time such that they are able to obtain 9 hours of nightly sleep (9.5 hours in bed, leaving up to ½ hour to fall asleep). Researchers will work with the adolescent and their family to problem-solve how to accomplish this sleep duration goal.
16020797|NCT02732756|Behavioral|Shortened Sleep Duration|This study examines shortened sleep duration as related to poorer functioning in adolescents with ADHD. Adolescent participants will be instructed to go to bed at a time such that they are in bed for 6.5 hours per night. Researchers will work with the adolescent and their family to problem-solve how to accomplish this sleep duration goal.
16020798|NCT02732743|Dietary Supplement|Physiomanna® Baby|Dosage 1g/kg body, 2 cycles (if applicable)
16020799|NCT02732730|Drug|Truvada|400 women who accept to initiate PrEP
16020800|NCT02732717|Other|ultrasound (observation)|"Important sonographic indices are to be collected from 11-14 weeks, 16-18 weeks, 22-24 weeks, 30-32 weeks and 37-39 weeks,including crown-rump length, nuchal translucency, amniotic fluid, umbilical artery flow, middle cerebral artery flow,ductus venous flow. It is observational.
~Conditions as below are thought abnormal: discordance of crown-rump length more than 20%, discordance of nuchal translucency more than 20%, either of twin with abnormal amniotic fluid (polyhydramnios or oligoamnios), either of twin with abnormal umbilical artery flow (elevated resistance index, absent or reverse diastolic flow), either of twin with abnormal middle cerebral artery flow (more than 1.5Mom), either of twin with abnormal ductus venous flow (absent or reverse a-wave)."
16020801|NCT02732704|Device|JenaValve Pericardial TAVR System|TAVR with JenaValve Pericardial Valve and Delivery System
16020802|NCT02732691|Device|JenaValve Pericardial TAVR System|Transcatheter aortic valve replacement (TAVR) will be performed using the JenaValve Pericardial valve and delivery system.
16020803|NCT02732678|Drug|PROPRANOLOL|
16020804|NCT02732639|Drug|Pegylated Interferon (PEG-IFN) alfa-2a|Participants received pegylated interferon (PEG-IFN) alfa-2a 180 microgram (mcg) subcutaneously (SC) weekly for 48 weeks.
16020805|NCT02732626|Procedure|radiofrequency ablation|
16020806|NCT02732613|Device|Laryngeal Mask Airway|If there were any conflicts of the Laryngeal Mask Airway classic size selection in slim patients by the actual or ideal body weight, size selection will based on actual body weight in Actual weight Group while ideal body weight in Ideal weight Group.
16020807|NCT02732600|Other|Facilitated Implementation|Facilitated Implementation sites will receive one year of support based on the i-PARIHS implementation model which includes training, implementation planning, ongoing external facilitation, feedback and consultation
16020808|NCT02732587|Drug|Saracatinib|Subjects will receive 125 mg Saracatinib for 8-11 days followed by an alcohol interaction lab session
16020809|NCT02732574|Device|Oscilatory Positive Expiratory Pressure (OPEP) device|OPEP devices will be set to the highest pressure setting tolerated on POD #1. If the highest pressure setting is not achieved on POD#1, the PT will increase the pressure daily with the aim to achieve the highest pressure setting as soon as tolerated by the patient or POD#3, whichever comes first. Patients will be instructed to complete 15 breaths in a seated position with the OPEP device twice per waking hour. This will occur in addition to usual care.
16020810|NCT02732574|Device|SHAM Device Group|SHAM devices will be provided to patients on POD #1 and set to the highest pressure setting externally, however no positive expiratory pressure will be provided as the internal pressure regulating mechanism has been removed. Patients will be instructed to complete 15 breaths in a seated position with the sham device twice per waking hour. This will occur in addition to usual care.
16020811|NCT02732561|Device|Alpha Stim device|cranial electrotherapy stimulation device
16020812|NCT02732561|Device|Sham device|Sham device
16020813|NCT02732548|Other|Negative Pressure Wound Therapy (NPWT)|
16020814|NCT02732548|Other|MIRODERM Application(s)|
16020815|NCT02732548|Other|Standard Care|wound measurement, debridement, photography of wound, moist wound environment, infection management, nutritional support
16020816|NCT02732535|Procedure|sleeve gastrectomy , roux-en-y gastric bypass|laparoscopic sleeve gastrectomy or laparoscopic gastric bypass
16020817|NCT02732522|Drug|Sublingual misoprostol|
16020818|NCT02732522|Drug|Vaginal misoprostol|
16020819|NCT02732496|Behavioral|Targeted Cognitive Training (TCT)|The instructors have selected a set of computer exercises designed to specifically target working memory, which is a cognitive construct relevant to ADHD and Tourette Syndrome. The tasks were designed to benefit subjects through principles of learning-dependent plasticity.
16020820|NCT02732496|Other|Youth Appropriate Online Games|Engaging games not designed to improve cognition.
16020821|NCT02732483|Drug|Endo-Clot(TM)|The patients agreed in this study, bleeding control will going to be done with Endo-Clot(TM)
16020822|NCT02732470|Other|Qi Gong|The aim of this study is to evaluate the effects of Qi Gong on quality if life in patients with Systemic Lupus Erythematosus
16020823|NCT02732431|Other|Sleep Symptom|Questionnaires, skin allergy test, overnight polysomnography
16020824|NCT02732418|Drug|Depo-Provera CI|The active ingredient in Depo-Provera is Medroxyprogesterone acetate (MPA)
16020825|NCT02732418|Drug|Depo-subQ 104|The active ingredient in Depo-Provera is Medroxyprogesterone acetate (MPA). Depo-subQ provera 104® (medroxyprogesterone acetate injectable suspension, 104 mg/0.65mL) for subcutaneous injection
16020826|NCT02732405|Drug|MK5172 /MK8742|tablets of MK-5172 100 mg/MK-8742 50 mg will be administered orally, daily for 12 weeks without ribavirin
16020827|NCT02732392|Procedure|standard lymphadenectomy|
16020828|NCT02732392|Procedure|lymphadenectomy radio-isotope method|
16020829|NCT02732379|Procedure|Lavender Aromatherapy|the two drops of lavender essential oil will be dropped into the gauze and the patient will inhale it for 5 minutes.
16020830|NCT02732379|Procedure|Rose Aromatherapy|the two drops of rose essential oil will be dropped into the gauze and the patient will inhale it for 5 minutes.
16020831|NCT02732379|Procedure|Ginger Aromatherapy|the two drops of ginger essential oil will be dropped into the gauze and the patient will inhale it for 5 minutes.
16020832|NCT02732379|Procedure|Placebo Aromatherapy|the two drops of pure water will be dropped into the gauze and the patient will inhale it for 5 minutes
16020833|NCT02732366|Behavioral|Group-based exercise and peer coaching|Group-based exercise and peer coaching will take place over 6 weeks plus one booster visit after 3 months, and include physical therapist-led 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions) to include: progressive strengthening, balance and mobility exercises; patient goal setting; peer coaching training activities to teach group members ways to help each other to meet their exercise goals during and after classes are over. There will be an individualized home program including flexibility, strengthening, walking, and balance, as well as activity monitoring.
16020834|NCT02732366|Other|Usual PT and attention control grp class|The usual PT and attention control group class will receive standard one-on-one PT strength, balance, gait and education intervention, and group classes to provide valuable information about healthy living, including nutrition, relaxation, and stress management. The attention control - healthy living group classes will take place over 6 weeks plus one booster visit after 3 months, and include 1 hour sessions 2 times per week for 2 weeks followed by once per week for 4 weeks (8 sessions).
16020835|NCT02732353|Dietary Supplement|Minced beef|Cow meat protein supplement
16020836|NCT02732353|Dietary Supplement|Hydrolyzed beef|Cow meat protein supplement
16020837|NCT02732340|Procedure|triple-branched stent graft|place the triple-branched stent graft into the aortic arch, descending aorta ,the left subclavian artery, the left common carotid artery, and the innominate artery.
16020838|NCT02732327|Drug|CAZ-AVI|Ceftazidime-Avibactam (2 g ceftazidime and 0.5 g avibactam)
16020839|NCT02732327|Drug|Vancomycin|15 mg/kg
16020840|NCT02732327|Drug|Linezolid|600 mg
16020841|NCT02732327|Drug|Cefepime|2 g
16020842|NCT02732327|Drug|Meropenem|1 g
16020843|NCT02732327|Drug|Piperacillin/tazobactam|4.5 g
16020844|NCT02732314|Drug|Investigational OTC Cream|
16020845|NCT02732314|Other|Cosmetic Eczema Cream|
16020846|NCT02732314|Drug|0.05% Desonide Cream|
16020847|NCT02732314|Other|Placebo Cream|
16020848|NCT02732288|Dietary Supplement|melatonin|After measuring the subject's own timing of release of melatonin, subjects will be provided a dose of melatonin at 8pm to test the effects on the electrical activity of sleep, measured using electroencephalography. The same intervention will be given to healthy, non-brain injured controls.
16020849|NCT02732275|Drug|DS-3201b|
16020850|NCT02732262|Drug|Oxycodone, 1.00 mg dose|Intravenous oxycodone is provided as patientcontrolled analgesia after surgery with bolus dose of 1.00 mg.
16021059|NCT02730793|Drug|Nasal Aztreonam|Study Therapy (nasal Aztreonam 75mg twice per day)
16020852|NCT02732262|Drug|Oxycodone, 0.02 mg/kg dose|Intravenous oxycodone is provided as patientcontrolled analgesia after surgery with bolus dose of 0.02 mg/kg.
16020853|NCT02732249|Drug|Esomeprazole|Given 30 min before morning and evening meals
16020854|NCT02732249|Drug|Bismuth Potassium Citrate|Given 30 min before morning and evening meals
16020855|NCT02732249|Drug|Clarithromycin|Given 30 min after morning and evening meals
16020856|NCT02732249|Drug|Metronidazole|Given 30 min after meals or at bedtime
16020857|NCT02732236|Other|Rituximab|Cohort observation study
16020858|NCT02732223|Dietary Supplement|Functional treatment|Omega 3 fatty acids, plant sterols and polyphenols
16020859|NCT02732223|Dietary Supplement|Control treatment|placebo supplements
16020860|NCT02732197|Drug|Sedation|Parturients who received IV thiopental 2 mg kg-1 and if necessary additional 50 mg immediately after spinal anesthesia until reaching at least Ramsay sedation score of 3 (1: patient anxious, agitated or restless, 6: patient with no response to light glabella tap or loud auditory stimulus.).
16020861|NCT02732197|Drug|No sedation|Parturients did not receive any type of sedation after spinal anesthesia.
16020862|NCT02732184|Drug|Co-ArgI-PEG modified human arginase I|
16020863|NCT02732171|Other|Research Blood Collection|Multiple tubes of research blood collected for biomarker analyses (circulating tumor material, immune profiling)
16020864|NCT02732158|Other|Nutrition Products|a sachet containing AN777and amino acids; a carotenoid capsule
16020865|NCT02732145|Diagnostic Test|"Three Rings Vulvoscopy (TRIV)"|"Mapping of the vulvar lesions according to the three vulvar rings and specificity of the lesions during Three Rings Vulvoscopy technique (TRIV Form Data). Assessing of the data by the Vulvoscopy Index and the N-S-P Scheme."
16020866|NCT02732145|Procedure|Histopathology|Biopsy of the vulva in symptomatic patients, vulvar samples after labiaplasty in asymptomatic patients.
16020867|NCT02732132|Drug|Ketamine and Midazolam|This group was injected intravenous midazolam 0.1 mg/kg (maximum 4 mg), two minutes later, ketamine 1 mg/kg was given intravenously before the start of endoscopy.
16020868|NCT02732132|Drug|Propofol and Fentanyl|This group was injected intravenous fentanyl 1 mcg/kg, and two minutes later, propofol 1 mg/kg was given intravenously before the start of endoscopy.
16020869|NCT02732119|Drug|Ribociclib|supplied in 50 mg, 200 mg capsules/tablets taken orally and dosed daily for 28 day cycle
16020870|NCT02732119|Drug|Everolimus|supplied in 2.5 mg tablets taken orally, daily for 28 day cycle
16020871|NCT02732119|Drug|Exemestane|supplied in 25 mg tablets taken orally, daily for 28 day cycle
16020872|NCT02732093|Procedure|stellate block|
16020873|NCT02732093|Drug|Na.Cl 0.9% (placebo)|
16020874|NCT02732093|Drug|lidocaine 2%|
16020875|NCT02732080|Device|deferred coronary stenting|Final coronary stenting will be performed when coronary auto regulation was recovered (approximately 30 minutes after establishment of TIMI III flow şn the infarct related artery)
16020876|NCT02732080|Device|immediate stenting|Stent implantation will be performed immediately after balloon angioplasty (or thrombectomy or wire crossing) as it is performed in daily routine.
16020877|NCT02732067|Other|anesthesia related deaths|number of anesthetized patients who died in the perioperative period inside the hospital
16020878|NCT02732054|Biological|Recombinant Hepatitis B vaccine [(CIGB) La Habana, Cuba]|Different HBV vaccine regimen in each group
16020879|NCT02732015|Drug|Dexamethasone|Given IV
16020880|NCT02732015|Drug|Doxorubicin|Given IV
16020881|NCT02732015|Drug|Fosaprepitant Dimeglumine|Given IV
16020882|NCT02732015|Drug|Ifosfamide|Given IV
16020883|NCT02732015|Other|Laboratory Biomarker Analysis|Correlative studies
16020884|NCT02732015|Drug|Mesna|Given IV
16020885|NCT02732015|Drug|Ondansetron|Given IV
16020886|NCT02732015|Other|Questionnaire Administration|Ancillary studies
16020887|NCT02732015|Drug|Rolapitant Hydrochloride|Given PO
16020888|NCT02732015|Drug|Vincristine Sulfate|Given IV
16020889|NCT02732002|Procedure|OCBRA ( Objective Criteria Based REhabilitation Algorithm|The patient will complete the initial functional and clinical evaluation in the medical room and laboratory. Afterwards, all the gathered information will be assembled to generate the patient-specific functional and clinical status-based rehabilitation program. This program will be generated in conjunction with the physical therapy staff. For each of the functional or clinical deficits observed during the examination, the physical therapist will identify the precise exercise and goal-based progression from a previously standardized goal-based rehabilitation algorithm adapted from previously published investigations targeting this issue
16020890|NCT02731976|Other|Dietary intervention|
16020891|NCT02731963|Drug|Polyethylene glycol|Patients with colorectal pathology who underwent elective colorectal anastomosis, that were randomized into two groups; one of them received mechanical bowel preparation with polyethylene glycol (study group), and the other one received clear liquid diet(control group) .
16020892|NCT02731950|Drug|Magnesium Sulfate and Bupivacaine 0.125%|Each patient will receive bupivacaine 0.125% with 5% magnesium sulphate by infusion through a catheter used for epidural analgesia, positioned presternal.
16020893|NCT02731937|Device|GE Healthcare Revolution CT Scanner (CT Scanner)|Raw CT Scan Data
16020894|NCT02731924|Procedure|Ultrasound for Appendicitis|Point-of-care ultrasound to evaluate emergency department patients for suspected appendicitis
16020895|NCT02731911|Drug|dexamethasone intravitreal implant|Ozurdex® treatment for diabetic macular oedema as per standard of care in clinical practice.
16020896|NCT02731885|Drug|ABX464 Single dose|Two-periods, subjects received a single dose of 50mg of ABX464 in fed and fasted condition, separated by a wash-out period of at least 45 days.
16020897|NCT02731885|Drug|ABX464 Repeated dose|Subjects received 50mg of ABX464 every 3 days during 10 days in fasted or fed condition.
16020898|NCT02731872|Device|Airvo humidifier|"The Airvo humidifier has adjustable flow settings for delivery of fully saturated breathing gases at 37 °C, 100% humidity.
~Flow rates are adjustable between 15 and 45 l/min. Ambient air is drawn in by a low-capacity motor. When coupled to a medical oxygen supply, the regulation of delivered oxygen concentration is ensured."
16020899|NCT02731859|Device|Insertion of EndoBarrier for approximately one year|Insertion of EndoBarrier for approximately one year then explantation and follow-up
16021060|NCT02730793|Drug|Nasal Placebo|Placebo (nasal saline twice per day)
16020900|NCT02731846|Drug|Fluticasone furoate 100 mcg + Umeclidinium 62.5 mcg+Vilanterol 25 mcg|Dry white powder delivered via ELLIPTA inhaler(2 strips with 30 blisters each, first containing fluticasone furoate 100 mcg per blister and second containing Umeclidinium 62.5 mcg and Vilanterol 25 mcg per blister), administered as one inhalation of FF/UMEC/VI (100/62.5/25 mcg) once-daily in the morning
16020901|NCT02731846|Drug|Fluticasone furoate 100 mcg + Vilanterol 25 mcg|Dry white powder delivered via ELLIPTA inhaler (2 strips with 30 blisters each, first containing fluticasone furoate 100 mcg per blister and second containing Vilanterol 25 mcg per blister), administered as one inhalation of FF/VI (100/25 mcg) once-daily in the morning
16020902|NCT02731846|Drug|Umeclidinium 62.5 mcg|Dry white powder delivered via ELLIPTA inhaler (1 strip with 30 blisters containing Umeclidinium 62.5 mcg, administered as one inhalation once-daily in the morning
16020903|NCT02731846|Device|Placebo ELLIPTA inhaler|Placebo will be administered via ELLIPTA inhaler. Dry white powder administered as one inhalation each morning (1 strip with 30 blisters containing placebo)
16020904|NCT02731846|Drug|Albuterol/Salbutamol|Albuterol/salbutamol will be administered via metered-dose inhaler (MDI) with a spacer as needed throughout the study as a rescue medication
16020905|NCT02731833|Other|stannous fluoride|0.454% weight by weight (w/w) stannous fluoride containing 1100ppm fluoride
16020906|NCT02731833|Other|sodium monofluorophosphate|0.76% w/w sodium monofluorophosphate containing 1000ppm fluoride
16020907|NCT02731820|Dietary Supplement|Potassium citrate|Kcitr 3.064 milligrams daily in two tablets by mouth (1.032 milligrams every 12 hours)
16020908|NCT02731820|Dietary Supplement|Placebo|Excipients: 3.064 milligrams daily in two tablets by mouth (1.032 milligrams every 12 hours)
16020909|NCT02731820|Dietary Supplement|Vitamin D3|400 IU/die Vitamin D3 daily by mouth
16020910|NCT02731820|Dietary Supplement|Calcium carbonate|500 mg/die calcium carbonate daily by mouth
16020911|NCT02731807|Dietary Supplement|Dose A: TA-65 24mg, powder|
16020912|NCT02731807|Dietary Supplement|Dose B: TA-65, 8mg, powder|
16020913|NCT02731807|Dietary Supplement|Dose C: TA-65 3.2mg, capsule|
16020914|NCT02731807|Dietary Supplement|Dose D: TA-65 8mg, capsule|
16020915|NCT02731807|Dietary Supplement|Dose E: TA-65 32mg, capsule|
16020916|NCT02731794|Device|left ventricular assist|In left ventricular assist group, 100 IU/kg heparin was given to activated clotting time (ACT) greater than 180 seconds. A 22 French arterial cannula (Maquet, Irrlingen, Germany) was introduced into the ascending aorta, and a 26 French cannula (Eurosets, Medolla, Italy) into the left atrium and advanced into the left ventricle. The two cannulas are directly connected through a short, heparin-coated circuit to a centrifuge pump (Maquet, Getinge Group, Germany). A flow of 1.0 to 4.0 L/min/m2 is obtained and mean blood pressure was maintained 55-75 mm Hg. Note: Both LVA group and BiVA group have the operative protocols itself,includes different prime fluid and cannula pathway. The investigators think it is inapplicable to assign the different operative protocols to the Treatment Arm.
16020917|NCT02731794|Procedure|Biventricular assist|In biventricular assist group, the patients were routinely heparinized with a dose of 300 IU/kg heparin to ACT greater than 480 seconds. Cardiopulmonary bypass with a centrifuge pump (Maquet, Getinge Group, Germany) was established by 22 French aortic cannulation and 34 French two-stage venous cannula through the right atrial appendage. The extracorporeal circuit was primed with 2000 mL of lactated Ringer's solution, albumin, 25% mannitol and 5% NaHCO3. The flow was 1.0 to 4.0 L/min/m2 and mean blood pressure was maintained 55-75 mm Hg.
16020918|NCT02731781|Other|NONE . OBSERVATIONAL|OBSEVATION AND FOLLOW UP
16020919|NCT02731768|Behavioral|Standard|Participants will receive an evidence-based behavioral weight control program focused on physical activity and reducing caloric intake. They will be provided with a Fitbit Zip and digital body weight scale for self-monitoring of physical activity and body weight, respectively.They will track caloric intake via the MyFitnessPal smartphone application. They will have access to a study website and attend weekly, in-person group counseling sessions.
16020920|NCT02731768|Behavioral|Social support-enhanced|Participants will receive the same intervention components as the Standard group.Participants will also be provided with two extra Fitbit Zips and digital body weight scales to share with up to two persons in their social circle who will be invited to serve as their support partners.
16020921|NCT02731768|Device|Fitbit Zip|
16020922|NCT02731768|Device|Digital body weight scale|
16020923|NCT02731755|Other|Oat|The study oat intervention products will consist of 67.7g oatflake and 22.5g oatbran concentrate.
16020924|NCT02731755|Other|Control|60g cream of rice
16020925|NCT02731742|Biological|MK-1966|MK-1966 administered as an intravenous (IV) infusion
16020926|NCT02731742|Drug|SD-101|SD-101 administered as an intratumoral (IT) injection
16020927|NCT02731729|Drug|ipilimumab|
16020928|NCT02731729|Drug|nivolumab|
16020929|NCT02731716|Behavioral|New Payment Model|Providers will no longer be paid based upon FFS, but on the new payment model, which includes PMPM and quality incentives.
16020930|NCT02731716|Behavioral|Social Comparisons|Providers will receive weekly emails showing comparisons in quality metrics and total cost of care. They will be compared to other providers in their provider organization.
16020931|NCT02731716|Behavioral|A1c Member/Provider Incentive|Attributed members and their PCPs will receive up to $75 for a reduction of a1c by 0.5% per quarter (2 quarters).
16020932|NCT02731703|Device|Overdenture treatment|Conventional, FDA-approved prosthetics will be used in accordance with their labeling and pre-study prescribed standard treatment approach
16020933|NCT02731690|Drug|Aceneuramic Acid Extended-Release|oral tablets
16020934|NCT02731677|Other|Acupuncture|Acupuncture was applied on the acupoints F3 - BP6- VB34- IG4 - TA5 - C7 - PC6 - IG11 - VB20 - XIAOCHANXUE, once a week, eight sessions in the experimental group.
16020935|NCT02731664|Biological|GLP-1|Intravenous infusion of GLP-1
16020936|NCT02731664|Biological|Intravenous saline|Control
16020937|NCT02731651|Procedure|open hysterectomy|Hysterectomy with laparotomy incision.
16020938|NCT02731651|Procedure|laparoscopic assisted vaginal hysterectomy|Hysterectomy with laparoscopic assisstance.
16020939|NCT02731638|Drug|Intrastromal voriconazole|Subjects will receive three intrastromal voriconazole injections over 10 days. Intrastromal voriconazole injection is a routine procedure performed by Aravind Eye Hospital for fungal keratitis.
16020940|NCT02731638|Drug|Natamycin|Subjects will receive topical 5% natamycin drops hourly for 3 days.
16020941|NCT02731625|Other|Kettlebell training|Kettlebell training will be performed in 30 second work:rest intervals. Total training time will progress from 10 minutes at the beginning of the study to 20 minutes at the end.
16020942|NCT02731625|Other|Army Physical Readiness Training|Army Physical Readiness Training per Army Field Manual 7-22
16020943|NCT02731612|Drug|lurasidone|Atypical Antipsychotic
16020944|NCT02731612|Other|Placebo|Inactive substance
16020945|NCT02731599|Procedure|treadmill training with cues|20-minutes treadmill training per day, 6 times a week, for 4 weeks. Treadmill speed was previously set at 2.0 km/h and progressively increased until a maximum of 3.5 km/h, taking always into account the patients' physical abilities. All patients were evaluated at the enrolment and at the end of the 4-weeks treatment. The first evaluation consisted in one-minute walking on treadmill without the use of cues at 1.5 km/h speed, for all patients. The outcome measurements were: the average length of the right step, the average length of the left step, the coefficient of variance of both steps, and the gait cycle.
16020946|NCT02731586|Drug|Allogenic Mesenchymal stem cells|Allogenic mesenchymal stem cells are introduced during placement of dental implants.
16020947|NCT02731573|Drug|D-PLEX|D-PLEX will be administered as a single application during the open heart surgery (index procedure) immediately prior to sternal closure, as an adjunct to the standard care.
16020948|NCT02731573|Procedure|Open heart surgery|Subject will undergo open heart surgery according to standard of care
16020949|NCT02731560|Drug|Rituximab|"Rituximab was administered as an intravenous infusion as per approved protocol on Day 1 and day 14. The protocol stipulated the administration of intravenous hydrocortisone 100 mg and oral pheniramine maleate 43.5 mg as pre-medication. The Rituximab itself was given as a 1 gm infusion slowly over a period of 4-6 hours.
~This was done either by a specialist nurse or a trained doctor."
16020950|NCT02731547|Behavioral|Education Against Tobacco School-Based Intervention|
16020951|NCT02731534|Drug|Z-213|The total iron dosage is calculated based on hemoglobin value and the patients' weight, IV on day 1, 8 and 15 (if needed)
16020952|NCT02731534|Drug|Saccharated Ferric Oxide|The total iron dosage is calculated based on hemoglobin value and the patients' weight, IV two or three times per week
16020953|NCT02731521|Device|3 Tesla Scanning|Approximately 120 brain tumor patients 50 patients with non-glioma disease, and 5 healthy volunteers will be scanned at either 3 Tesla or 7 Tesla.
16020954|NCT02731521|Device|7 Tesla Scanning|Approximately 120 brain tumor patients 50 patients with non-glioma disease, and 5 healthy volunteers will be scanned at either 3 Tesla or 7 Tesla.
16020955|NCT02731508|Device|Bihemispheric transcranial direct current stimulation|5x5 cm tDCS electrode over C3 or C4 (10-20 system) with concurrent rehabilitation
16020956|NCT02731495|Dietary Supplement|EGCG|EGCG (Epigallocatechin -3-gallate)
16020957|NCT02731495|Dietary Supplement|Placebo (deionized water)|
16020958|NCT02731482|Other|Training Group|"Three sessions per week, each lasting 50 minutes, during eight weeks.
~Aerobic training in stepping training.
~Resistance training: Three sets of eight repetitions each, in both simultaneous members, using an elastic band. The trained muscles are quadriceps, hamstrings, deltoid and biceps.
~Once a week, patients will receive a phone call and every two weeks, patients will get a visit of the researcher at his home."
16020959|NCT02731482|Other|Control Group|"The participants will receive verbal and written information about the importance of physical activity and walk in moderate intensity, at least, three times a week for 30 minutes.
~Participants will not receive any supervised physical training.
~Once a week, patients will receive a phone call to provide support and general advice."
16020960|NCT02731469|Biological|BCD-131|
16020961|NCT02731469|Biological|Mircera®|
16020962|NCT02731469|Biological|Aranesp®|
16020963|NCT02731456|Other|altitude exposure|altitude exposure
16020964|NCT02731443|Procedure|Epilepsy surgery|Epilepsy surgery is a procedure that removes an area of the brain where seizures originate.
16020965|NCT02731443|Procedure|Depth electrodes insertion|Depth electrodes are inserted for monitoring/mapping the subsurface levels of the brain for the surgical treatment of epilepsy.
16020966|NCT02731430|Drug|intrathecal morphine|received 0.3mg morphine (0.3ml) added to 1.2ml of bupivacaine 0.5% (total volume 1.5ml), intrathecally, immediately before induction of general anesthesia.
16020967|NCT02731430|Drug|intrathecal saline|received 0.3ml saline added to 1.2mlof bupivacaine 0.5% (total volume 1.5ml), intrathecally, immediately before induction of general anesthesia.
16020968|NCT02731417|Other|acupuncture|Acupuncture for women with post partum urinary retention
16020969|NCT02731417|Device|Foley catheter|Foley catheter insertion for women with post partum urinary retention.
16020970|NCT02731404|Procedure|HFJV ventilation|The investigators used the Perkins tonometer for monitoring intra-ocular pressure. Evaluation of intra-ocular pressure was done before induction of anesthesia, end of induction, during surgery and at the end of surgery.
16020971|NCT02731404|Procedure|IPPV ventilation|The investigators used the Perkins tonometer for monitoring intra-ocular pressure. Evaluation of intra-ocular pressure was done before induction of anesthesia, end of induction, during surgery and at the end of surgery.
16020972|NCT02731391|Procedure|Pelvic floor reconstruction（with or without mesh）|
16020973|NCT02731378|Drug|Erythropoietins (EPO)|A routine dose 10,000 IU of EPO, three times weekly by subcutaneous injections.
16020974|NCT02731378|Drug|Aggressive iron dextran supplementation|Iron dextran 100 mg, BIW, through 90 minutes of IV infusion, for the first consecutive 5 weeks
16020975|NCT02731378|Drug|Erythropoietins (EPO)|Doubling EPO dosage to 20,000 IU, three times weekly by subcutaneous injections with a maximum of 5 doses
16020976|NCT02731378|Drug|Sustained iron dextran supplementation|Iron dextran 200 mg, Q3W, through 90 minutes of IV infusion and a maximum of 5 doses
16020977|NCT02731365|Device|Activa PC+S|The Activa PC+S is a newly developed Medtronic DBS implantable system and is available for use in clinical research. This system has a mechanism for both sensing of LFP and the ability to provide deep brain stimulation therapy. The sensing capabilities are controllable with data management using a clinician sensing tablet programmer that has a USB extension allowing for telemetry to an encrypted, locked computer.
16020978|NCT02731352|Drug|Apatinib|Apatinib Mesylate Tablets 750 mg q.d p.o. in 1-10 cases of differentiated thyroid cancer subjects.
16020979|NCT02731352|Drug|Apatinib|Apatinib Mesylate Tablets 500 mg q.d. p.o. in 11-20 cases of differentiated thyroid cancer subjects.
16020980|NCT02731339|Device|Spinal Mouse® measurement|The sagittal thoracic spinal curvature and mobility of all participants were assessed with Spinal Mouse® (Idiag, Fehraltorf, Switzerland) in standing position.
16020981|NCT02731339|Behavioral|Low back pain intensity measurement|Low back pain intensity of the patients was questioned by Visual Analogue Scale
16020982|NCT02731339|Behavioral|Urogenital symptoms measurement|The presence and severity of various urogenital symptoms was assessed with the Urogenital Distress Inventory-6
16020983|NCT02731339|Behavioral|Disability caused by low back pain|Disability caused by low back pain was assessed with the Oswestry Disability Index
16020984|NCT02731326|Device|AliveCor|"The AliveCor Heart Monitor, an FDA-approved smartphone technology, snaps on to the patient's study smartphone similar to a protective case and works through a free application, AliveECG. It captures a highly sensitive (98%), specific (97%), and accurate (97%) single-lead ECG recording through two electrodes on the back of the patient's smartphone. When the application is opened, recording begins automatically when both electrodes make contact with skin. Transmissions are automatically uploaded to the study patient portal within the AliveCor cloud."
16020985|NCT02731326|Behavioral|Behavioral Altering Messaging|Behavioral altering messages relating to the participant's AF and underlying cardiac risk factors will be systematically selected from a bank of text messages developed through collaboration by the study team and an expert interdisciplinary panel from the American Heart Association. The content of the text messages will not include PHI. The final text message bank will be housed internally and maintained by the Data Manager and text messages will be pushed automatically from this database. The only identifying link to participants included in this database will be their study-provided phone number
16020986|NCT02731313|Biological|Trastuzumab|Trastuzumab was not administered in this study. This study informs future trastuzumab treatment decisions.
16020987|NCT02731300|Device|tDCS|brain stimulation by cathodal electrode at motor cortex
16020988|NCT02731287|Drug|Timolol|The patient will be treated with 2 drops twice a day over the lesion and rub with the finger (no occlusive) for 24 weeks
16020989|NCT02731287|Drug|Placebo|The patient will be treated with 2 drops twice a day over the lesion and rub with the finger (no occlusive) for 24 weeks
16020990|NCT02731274|Other|Regular physical activity in Motor memory consolidation|After the intervention, the assessment of the impact of exercise on motor memory consolidation was held in three stages: Training; 1 hour after training and 24 hours after training. For the analysis of the results, descriptive and inferential statistics were used.
16020991|NCT02731261|Other|Motor memory consolidation|Subjects were divided in two groups: a control group and an experimental group. Before the intervention of a physical exercise program, subjects performed a Finger Tapping Sequence to measure baseline performance. After the intervention, the assessment of the impact of exercise on motor memory consolidation was held in three stages: Training; 1 hour after training and 24 hours after training.
16020992|NCT02731248|Other|Prospective screening study|Prospective screening study in newborns
16020993|NCT02731235|Other|High-intensity training|high intensity training 5 days a week for 12 weeks
16020994|NCT02731235|Drug|prophylactic stroke medication|Usual care medication for stroke prophylaxis
16020995|NCT02731235|Behavioral|Recommendations for lifestyle changes|Advise on diet, alcohol, smoking and exercise
16020996|NCT02731222|Other|observational cross-sect. analytical inferential unicentric|collecting data from patients of the Service of Angiology and Vascular Surgery of the Hospital de Sant Pau
16020997|NCT02731209|Device|urinary catheter|
16020998|NCT02731196|Behavioral|Exercise Intervention|Early versus later stabilization and neurodynamic exercise intervention following a post-op lumbar microdiscectomy
16020999|NCT02731183|Procedure|fecal microbiota transplantation|Patients received frozen FMT on 6 consecutive days through nasojejunal tubes.
16021000|NCT02731170|Behavioral|MIRT|MIRT consists of a 4-week physical therapy, in a hospital setting, which entails four daily sessions for five days and one hour of physical exercise on the sixth day. The duration of each session is about one hour. The first session consists of a one-to-one session with physical therapist involving muscle stretching. The second session includes aerobic exercises to improve balance and gait using different devices: a stabilometric platform, treadmill plus, crossover and cycloergometer. The third is a session of occupational therapy to improve autonomy in everyday activities. The last session includes one hour of speech therapy
16021001|NCT02731157|Drug|Rejuvesol|
16021002|NCT02731157|Procedure|Blood transfusion|Only transfusions necessary for the treatment of the sickle cell disease will be given for the purpose of the study.
16021003|NCT02731144|Other|Peptamen intense|
16021004|NCT02731144|Other|Novasource senior|
16021005|NCT02731131|Drug|Peginterferon alfa-2a|Peginterferon alfa-2a will be administered as 180 micrograms (mcg) once weekly via subcutaneous (SC) injection.
16021006|NCT02731131|Drug|Ribavirin|Ribavirin will be administered as 1000 to 1200 milligrams (mg) per day in divided oral doses.
16021007|NCT02731118|Dietary Supplement|Salovum|AF-enriched egg yolk
16021008|NCT02731118|Dietary Supplement|Placebo|egg yolk
16021009|NCT02731105|Drug|Acnatac® Gel left face|topical application
16021010|NCT02731105|Drug|Epiduo® Gel right face|topical application
16021011|NCT02731105|Drug|Acnatac® Gel right face|topical application
16021012|NCT02731105|Drug|Epiduo® Gel left face|topical application
16021013|NCT02731092|Dietary Supplement|Lactoferrin|Bovine Lactoferrin 100 mg/ml dissolved in sterile water
16021014|NCT02731079|Device|Covidien iDrive|Surgery performed with Covidien powered stapler
16021015|NCT02731079|Device|Ethicon Echilon|Surgery performed with Ethicon powered stapler
16021016|NCT02731066|Other|Standard pro|Volunteers will receive dietary protein at 1.0 ± 0.2 g/kg/d.
16021017|NCT02731066|Other|High pro|Volunteers will receive dietary protein at 2.0 ± 0.2 g/kg/d.
16021018|NCT02731066|Other|carbo bev|During aerobic performance testing, volunteers will receive a beverage containing 80 g glucose + 65 g fructose consumed at a rate providing ~1.8 g carbohydrate/min.
16021019|NCT02731066|Other|placebo bev|During aerobic performance testing, volunteers will receive a volume and flavor-matched, non-nutritive placebo beverage.
16021057|NCT02730806|Behavioral|NLP|NLP techniques, such as VKD, visual/auditory/kinesthetic swishes, modified especially for PTSD, will be implemented one-on-one with each woman in this arm.
16091958|NCT02222116|Device|Control BMS DES|
16021020|NCT02731053|Behavioral|Blues program|Participants will attend 6 weekly 1-hour sessions of group cognitive-behavioral therapy administered by school staff, and will do home practice between sessions and after the program individually using a web site (called the Blues App)
16021021|NCT02731040|Drug|Bisphosphonate|
16021022|NCT02731014|Other|Dry Needling|Dry Needling targeting the posterior musculature of the cervical and thoracic spine.
16021023|NCT02731014|Other|Sham Dry Needling|Sham Dry Needling performed with Park sham acupuncture needles (Acuprime, UK) will be used to perform sham dry-needling. The device consists of 2 plastic tubes that slide into one another and cause a pricking sensation when pushed against the skin.
16021024|NCT02731014|Other|Manual Therapy|Manual Therapy(mobilization/ manipulation) to address joint mobility of the cervical and thoracic spine.
16021025|NCT02731014|Other|Exercise|Exercise designed to improve performance of both the deep neck flexor musculature as well as the scapular musculature. The exercise portion will also include a stretching program targeting the cervicothoracic muscles which have been placed in a shortened position as a result of poor postures.
16021026|NCT02731001|Radiation|Proton therapy|
16021027|NCT02731001|Radiation|Photon therapy|
16021028|NCT02730988|Behavioral|Weight Stable Group|The weight stable control group is monitored bi-weekly by study staff to ensure weight stability over the course of the study. During group sessions, participants are weighed and encouraged to maintain weight within ±5% of baseline. They also receive non-weight loss health related topics presented by study staff. If participants attend 75% of the educational sessions, all baseline and follow-up testing sessions, and maintain weight stability over the course of the study (defined as less than a 5% differential between weight measured at week 0 and 24), they will be eligible to receive up to 3 months of Medifast MRPs along with a 30-60 minute RD-led dietary instruction session on how to follow the Medifast 4 & 2 & 1 Plan.
16021029|NCT02730975|Drug|AA Reduced dose-normal diet (A)|Cycles of 28 days length of AA at reduced doses (250 mg) administered with a pre-defined normal diet, described with specific caloric and fat content.
16021030|NCT02730975|Drug|AA reduced dose-fat diet (B)|Cycles of 28 days length of AA at reduced doses (250 mg) administered with a pre-defined fat diet, described with specific caloric and fat content.
16021031|NCT02730975|Drug|AA normal dose-fasting conditions (C)|Cycles of 28 days length of AA at approved doses (1000 mg) administered in fasting conditions.
16021032|NCT02730962|Drug|Vancomycin|Vancomycin 3 times a day for 7 days
16021033|NCT02730962|Other|Placebo|Placebo pills identical in appearance to each antibiotics to be taken on the same schedule as each antibiotic
16021034|NCT02730962|Drug|Neomycin|Neomycin 3 times a day for 1 day
16021035|NCT02730962|Drug|Clindamycin|Clindamycin 3 times a day for 5 days
16021036|NCT02730962|Procedure|Fecal Microbiota Transplantation|FMT conducted via colonoscopy
16021037|NCT02730949|Dietary Supplement|D-chiro-inositol|Treated group
16021038|NCT02730949|Dietary Supplement|Folic Acid|Control group
16021039|NCT02730936|Device|Antimicrobial Hernia Repair Device|hernia repair
16021040|NCT02730923|Drug|AZD2014|"Following inclusion, patients will be randomized (2:1) to receive Arm A : AZD2014 + anastrozole Arm B : anastrozole alone
~Mode of Action Selective and specific mTOR kinase inhibitor targeting both mTORC1 and mTORC2 complexes.
~Route of Administration Oral
~Dosage regimen 125mg BID with intermittent schedule (2 days of treatment followed by 5 days off (500mg/week))
~Duration of treatment Until the patient experiences unacceptable toxicity, disease progression and/or treatment is discontinued per patient or investigator request."
16021041|NCT02730923|Drug|Anastrozole|"Therapeutic Class Aromatase inhibitor
~Mode of Action Potent and highly selective non-steroidal aromatase inhibitor.
~Route of Administration Oral
~Dosage regimen
~1 mg tablet once a day
~Duration of treatment Patients may continue treatment with anastrozole until the patient experiences unacceptable toxicity, disease progression and/or treatment is discontinued per patient or investigator request."
16021042|NCT02730910|Other|Purple Wheat Crackers|Whole grain crackers manufactured with purple wheat
16021043|NCT02730910|Other|Purple Wheat Granola Bars|Whole grain granola bars manufactured with purple wheat
16021044|NCT02730897|Procedure|Central/Peripheral|Central versus peripheral location of the primary tumor
16021045|NCT02730884|Drug|Rigosertib|Participants take 560 mg Rigosertib by mouth in the morning (two 280 mg capsules) and 560 mg Rigosertib in the afternoon.
16021046|NCT02730884|Behavioral|Questionnaire|Quality of life questionnaire completed on Day 1 of Cycle 1. It should take about 10-15 minutes to complete.
16021047|NCT02730871|Drug|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension|
16021048|NCT02730871|Drug|Brinzolamide/brimonidine vehicle|Inactive ingredients used as placebo comparator
16021049|NCT02730871|Drug|Travoprost 0.004%/timolol 0.5% solution|1 drop instilled in the affected eye(s) daily in the morning (at 9:00) or in the evening (at 21:00) for up to 10 days during the Screening/Eligibility Phase and 42 days during the Treatment Phase
16021050|NCT02730858|Behavioral|Palliative and Oncology Care|Patients randomized to the intervention will receive collaborative care from palliative care and oncology for the remainder of their illness. The initial five visits with palliative care will be conducted in accordance with the study specific clinical practice guidelines and occur at least monthly.
16021051|NCT02730858|Behavioral|Standard Oncology Care|Patients randomized to oncology care alone will continue to receive routine care identical to what they would have received if they had not participated in the trial. Either patients or their oncologists can request palliative care consultation at any point in time.
16021052|NCT02730845|Drug|Intra-articular dexmedetomidine|Patients will receive an intra-articular mixture of 19 ml bupivacaine 0.5% with epinephrine 1:200.000 added to 1ml (1 µg/kg) of dexmedetomidine (total volume 20 ml), and i.v. saline 20 ml infused over 10 min starting with local anesthesia
16021053|NCT02730845|Drug|Intravenous dexmedetomidine|Patients will be injected intra-articularly with mixture of 19 ml 0.5% bupivacaine with epinephrine 1:200.000 and 1 ml of isotonic saline (total volume 20 ml), in addition to i.v. 20 ml saline containing 1 µg/kg dexmedetomidine over 10 min infusion starting with local anesthesia.
16021054|NCT02730832|Other|Questionnaires completed at D0|
16021055|NCT02730832|Other|Questionnaires completed at D15 (test-retest for 30 patients)|
16021056|NCT02730819|Drug|Illuminate Cream|Topical compound applied daily
16021058|NCT02730793|Drug|Oral Aztreonam|Standard Therapy Comparator (Oral Cayston 75mg three times a day)
16021061|NCT02730780|Dietary Supplement|Low-Salt Diet|The low-salt diet (7 days) will consist of meals, snacks, and sodium free water provided by the study staff.
16021062|NCT02730780|Dietary Supplement|High-Salt Diet|The high-salt diet (7 days) consists of each subject's usual diet, supplemented each day with 2 bouillon broth packets, which will be provided to the subject by the study staff.
16021063|NCT02730767|Behavioral|partially supervised exercise intervention|
16021064|NCT02730741|Drug|Lcr restituo® sachet|symptomatic treatment of diarrhoea
16021065|NCT02730741|Drug|Placebo|
16021066|NCT02730728|Drug|20ml bolus of 0.5% ropivicaine|Local anesthetic
16021067|NCT02730728|Drug|0.2% Ropivicaine at 8 milliliter/hour|Local anesthetic
16021068|NCT02730728|Drug|5ml bolus of 0.5% ropivicaine|Local anesthetic
16021069|NCT02730715|Drug|Basiliximab|Periodic blood collection to monitor Treg cells
16021070|NCT02730715|Drug|Thymoglobulin|Periodic blood collection to monitor Treg cells
16021071|NCT02730702|Device|LEBS - Low coherence enhanced backscattering|Unprepped patients will have the LEBS probe brought into contact with the rectal mucosa, upon which 10 random readings will be obtained.
16021072|NCT02730689|Drug|DP-R207|
16021073|NCT02730689|Drug|Rosuvastatin|
16021074|NCT02730689|Drug|Ezetimibe|
16021075|NCT02730676|Other|Electronic Cigarette #1|VUSE® Digital Vapor Cigarettes (original flavor, 29 mg nicotine)
16021076|NCT02730676|Other|Electronic Cigarette #2|VUSE® Digital Vapor Cigarettes (menthol flavor, 29 mg nicotine)
16021077|NCT02730663|Device|Niti-S SPAXUS Stent|Endoscopic Ultrasound-Guided Transluminal drainage
16021078|NCT02730650|Other|Platelet Rich Therapy (PRT)|Platelet Rich Therapy (PRT) involves injection of patient's own platelets and fibrin.Topical anesthetic will be applied to the face for a period of fifteen minutes prior to the injection. For PRP preparation, 8 cc of blood will be collected from each patient just before each procedure. Approximately 0.3-0.4 cc of PRP will be injected into each standardized injection point in a superficial manner. The injections points are 6 points on each side of the face along the inferior border of cheek and mid-cheek (12 total). The PRP injection will be followed by 10-15 minutes of icing.
16021079|NCT02730637|Other|Early nephrologist consultation|
16021080|NCT02730624|Drug|Piperacillin-tazobactam|4.5 g of piperacillin/tazobactam in 100 ml of normal saline solution was administered via an infusion pump at a constant flow rate 30 min every 6 h and blood sample were obtained by direct venepuncture at 0, 0-0.5, 0.5-2, 2-4 and 4-6 hour after drug administration
16021081|NCT02730598|Device|Hybrid Training System (HTS)|Electrodes (15 cm x 6 cm) will be placed over the quadriceps and electrodes (11 cm x 6 cm) (Sekisui Plastics Co., Tokyo, Japan) will be placed over the hamstrings. Electrical stimulation parameters will be based on a standard Russian waveform in which a 5,000 Hz carrier frequency is modulated at 40 Hz (2.4 ms on, 22.6 ms off) to deliver a rectangular voltage biphasic pulse. Acceleration sensors as a joint motion sensor (EWTS9PD, Home Appliances Development Center Corporate Engineering Division, Appliances Company Panasonic Corporation 2-3-1-2 Noji-higashi,Kusatsu City, Shiga, Japan) is placed on the front of each leg 88mm above the patellar edge. It analyzes the algorithm of each exercise pattern, and stimulates the antagonist of the motion of each bilateral knee joint during exercise. Electrical stimulation intensity will be set to ~50-60% of 1RM based on the subject's tolerance. The subject's tolerance gradually increases, and electrical stimulation intensity is reset every 2 weeks.
16021082|NCT02730598|Device|Sensory TENS|The electrical stimulation intensity will be set under the muscle contraction threshold (but at a level at which the subject can perceive as sensory TENS). Electrical stimulation parameters (i.e. waveform and pulse duration) will be the same of HTS, while the amplitude will be lower. The subject will be stimulated using the same device as for HTS.
16021083|NCT02730585|Biological|C-reactive protein measurement|All patients included in this study underwent a blood sample analysis for C-reactive protein concentrations at admission and 3 hours later.
16021084|NCT02730572|Drug|Concerta|This is an observational study. Participants who have been on Concerta for at least 60 days will be observed.
16021085|NCT02730572|Drug|Concerta AG formulation|This is an observational study. Participants who have been on Concerta for at least 60 days and switch to authorized generic will be observed.
16021086|NCT02730572|Drug|Concerta EG formulation|This is an observational study. Participants who have been on Concerta for at least 60 days and switch to equivalent generic will be observed.
16021087|NCT02730559|Other|Motivational Interviewing/Counselling|Motivational Interviewing/Counselling
16021088|NCT02730546|Drug|Carboplatin|Given IV
16021089|NCT02730546|Procedure|Computed Tomography|Undergo CT scan
16021090|NCT02730546|Drug|Fluorouracil|Given IV
16021091|NCT02730546|Other|Laboratory Biomarker Analysis|Correlative studies
16021092|NCT02730546|Drug|Leucovorin Calcium|Given IV
16021093|NCT02730546|Drug|Oxaliplatin|Given IV
16021094|NCT02730546|Drug|Paclitaxel|Given IV
16021095|NCT02730546|Biological|Pembrolizumab|Given IV
16021096|NCT02730546|Procedure|Positron Emission Tomography|Undergo PET scan
16021097|NCT02730546|Radiation|Radiation Therapy|Undergo radiation therapy
16021098|NCT02730546|Procedure|Therapeutic Conventional Surgery|Undergo curative-intent surgery
16021099|NCT02730533|Drug|Esomeprazole|Proton pump inhibitor
16021100|NCT02730533|Drug|No PPI treatment|No PPI treatment before ESD procedure
16021101|NCT02730520|Other|Retrospective analysis of patient files|The results of the allergen skin tests will be encoded as the edema diameter. The allergenicity score (mean of the skin reactivities for each allergen) will be compared between each age groups. The impact of tabagism, gender, BMI and residential area on the allergic reactivity will also be assessed in the overall population and within each age group.
16021102|NCT02730507|Device|Surgery with patient-specific rod|Bras A: PSRs must be used with the appropriate instrumentation designed by the same manufacturer. In order to minimize potential bias derived from using different spinal systems or reduction techniques, the posterior instrumentation must be the same (except the use of standard straight rod) in both groups. The surgical method to implement the PSR will be the same as the one to implement the conventional rod. Except for the bending procedure (patient specific rod or conventional rod with perioperative manual bending), the characteristics of implantable devices (biomaterial and diameter of the rod, design, type of screw, etc.) will be the same in each center.
16093037|NCT02214316|Other|Hypertonic Saline|
16021103|NCT02730507|Device|Conventional straight rod|Bras B: The control group is composed of patients operated with standard straight rods, which are bent in the operating room by the surgeon. In order to minimize potential bias derived from using different spinal systems or reduction techniques, the posterior instrumentation used in the control group must be the same (except the use of PSRs) than the experimental group.
16021104|NCT02730494|Device|Lcr Regenerans® vaginal capsules|
16021105|NCT02730494|Device|Lcr Regenerans® vaginal tablet|
16021106|NCT02730481|Drug|Oraxol|Oraxol will be supplied as paclitaxel capsules and HM30181AK-US tablets.
16021107|NCT02730455|Drug|natalizumab|Administered as specified in the treatment arm
16021108|NCT02730455|Drug|Placebo|Matched placebo
16021109|NCT02730442|Drug|F901318|Administration of F901318 intravenously
16021110|NCT02730442|Drug|Fluconazole|Oral administration
16021111|NCT02730429|Drug|Palbociclib/placebo|Palbociclib or a placebo is administered together with standard of care letrozole
16021112|NCT02730429|Drug|Letrozole|Letrozole is standard of care in both arms
16021113|NCT02730416|Drug|Nintedanib or Placebo; Carboplatin, Paclitaxel|Arm A: Nintedanib: 200mg orally twice daily d 2-21 q 21 days x 6 courses; afterwards daily dosing, until PD Arm B: Placebo: orally twice daily d 2-21 q 21 days x 6 courses; afterwards daily dosing, until PD In both arms: 6 courses of standard carboplatin and paclitaxel: Carboplatin AUC 5 iv every 21 days; Paclitaxel 175mg/m2 iv every 21 days. Both drugs are continued for maximum six courses or until unacceptable toxicity
16021114|NCT02730403|Other|Treatment As Usual|
16021115|NCT02730377|Drug|liraglutide|Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
16021116|NCT02730377|Drug|alpha-glucosidase inhibitors|Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
16021117|NCT02730377|Drug|DPP-4 inhibitors|Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
16021118|NCT02730377|Drug|meglitinides|Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
16021119|NCT02730377|Drug|SGLT-2 inhibitors|Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
16021120|NCT02730377|Drug|sulphonylurea|Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
16021121|NCT02730377|Drug|thiazolidinediones|Trial product will be prescribed by the investigator and dispensed by pharmacy or similar.
16021122|NCT02730364|Drug|Paracetamol, phenylephrine HCl, pheniramine maleate, and vitamin C|One sachet is provided for each participant randomized to the Theraflu Night powder containing paracetamol, phenylephrine HCl, pheniramine maleate, and vitamin C as oral solution.
16021123|NCT02730351|Drug|Fluticasone furoate/ Vilanterol 100 mcg/25 mcg|FF/VI 100/25 mcg will be administered via ELLIPTA inhaler once daily in the evening
16021124|NCT02730351|Drug|Fluticasone propionate 250 mcg|FP 250mcg will be administered via DISKUS inhaler, twice daily, once in the morning and once in the evening
16021125|NCT02730351|Drug|Placebo via ELLIPTA inhaler|Placebo will be administered via ELLIPTA inhaler once daily in the evening
16021126|NCT02730351|Drug|Placebo via DISKUS / ACCUHALER|Placebo will be administered via DISKUS / ACCUHALER, twice daily, once in the morning and once in the evening
16021127|NCT02730338|Behavioral|High intensity aerobic and resistance training|
16021128|NCT02730338|Behavioral|Psychosocial support|
16021129|NCT02730325|Other|Serum-derived bovine immunoglobulin/protein isolate (SBI)|
16021130|NCT02730325|Other|Placebo|
16021131|NCT02730312|Biological|XmAb14045|Administered IV weekly up to 8 weeks, with or without step-up dosing
16021132|NCT02730299|Drug|NiCord® (omidubicel)|
16021133|NCT02730299|Other|Cord Blood Unit|Cord blood unit
16021134|NCT02730286|Other|observational study|application of several standard instruments in patients with rheumatoid arthritis
16021135|NCT02730273|Device|Trial Nasal mask|Nasal mask for the treatment of obstructive sleep apnea (OSA)
16021136|NCT02730260|Behavioral|Nondirective smoking cessation coaching|Quitline coach allows participant to set agenda for each call.
16021137|NCT02730260|Behavioral|Directive smoking cessation coaching|Quitline coach follows a pre-specified agenda for each call, and does not allow participant to deviate from the agenda.
16021138|NCT02730247|Drug|ramucirumab|it is administered through a vein in the arm as a 60 minute infusion at a dose of 8 mg/kg on days 1 and 15 of a 28-day cycle.
16021139|NCT02730247|Drug|nab-paclitaxel|it is administered through a vein in the arm as a 30 minute infusion at a dose of 100 mg/m2 on days 1, 8 and 15 of a 28 day cycle.
16021140|NCT02730234|Device|JetStream XC with balloon angioplasty|JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic.
16021141|NCT02730208|Drug|Tezacaftor/Ivacaftor|TEZ 100 mg/IVA 150 mg fixed-dose combination tablet.
16021142|NCT02730208|Drug|Ivacaftor|IVA 150 mg tablet.
16021143|NCT02730208|Drug|Placebo|Placebo matched to TEZ/IVA fixed-dose combination tablet.
16021144|NCT02730208|Drug|Placebo|Placebo matched to IVA tablet.
16021145|NCT02730195|Drug|Pioglitazone|Given PO
16021146|NCT02730195|Drug|Tyrosine Kinase Inhibitor (TKI)|Given TKI therapy
16021147|NCT02730182|Other|altitude exposure|altitude exposure
16021148|NCT02730169|Drug|BGS649|Capsules were taken weekly for a maximum of 24 weeks
16021149|NCT02730169|Drug|Placebo|Capsules were taken weekly for a maximum of 24 weeks
16021150|NCT02730156|Other|Altitude exposure|Altitude exposure
16021151|NCT02730143|Other|Altitude exposure|Altitude exposure
16021152|NCT02730130|Drug|Pembrolizumab|
16021153|NCT02730130|Radiation|Radiotherapy|
16021154|NCT02730117|Device|Dialysis with continuous renal replacement therapy|Continuous renal replacement therapy is a form of 24-hour dialysis in the ICU
16021155|NCT02730117|Device|Mechanical ventilator|Invasive or noninvasive form of respiratory support
16021156|NCT02730117|Drug|Anti-Bacterial Agents|Antibacterial agents deemed appropriate by physicians in the ICU
16021157|NCT02730117|Drug|Vasopressors|Vasopressors such as Norepinephrine, dopamine, milrinone, dobutamine
16021158|NCT02730091|Drug|Letrozole|Letrozole 2.5 mg daily
16021159|NCT02730091|Drug|Anastrozole|anastrozole 1 mg daily
16094267|NCT02205398|Drug|cetuximab|
16021160|NCT02730091|Drug|Vinorelbine|50 mg three times a week (Monday Wednesday and Friday)
16021161|NCT02730078|Behavioral|VEMOFIT|The VEMOFIT intervention involves four biweekly two hours sessions over a period of about six weeks, and a booster at three months follow-up. It consists of a mixture of 1) exploring illness perceptions and personal meanings of diabetes, 2) cognition-focused education on diabetes and practical skills in self-management and 3) emotion-focused training on recognising emotions in the self and others. Each group will consist of 10 to 12 participants of equal representation by the patients and their significant others.
16021162|NCT02730078|Behavioral|Attention-meetings (AG)|Patients in the health clinics randomised to the AG, will receive the usual T2D care by the clinic doctors and education by the clinic paramedics based on the recommendations in the Malaysian clinical guidelines. At T1, T2 and T4, patients (not including their significant others) in AG will be gathered in groups of 10-12 people for the primary and secondary outcomes evaluation. This session will include general discussion on feeling about and coping with T2D, social support at home and satisfaction with treatment and care received at the respective clinics.
16021163|NCT02730065|Behavioral|Structured Aerobic Dance Training Group|Systematic physical activity
16021164|NCT02730065|Behavioral|Stretching plus education|Weekly group based stretching with psychoeducation and health education
16021165|NCT02730052|Device|Omron 9200T plus Telemonitoring|Telemonitoring of the self-measured blood pressure at home. After each blood pressure measurement the values are transmitted to and stored into a central station where a condensed weekly report is elaborated and delivered to the doctor (investigator).
16021166|NCT02730052|Device|Omron 9200T without Telemonitoring|Self-measured blood pressure at home and register the values in a diary card. Participants will perform 2 consecutive blood pressure measurements twice a day for a 7 day period, previous to the visit to the doctor's (investigator) office.
16021167|NCT02730039|Behavioral|workshop|
16021168|NCT02730039|Behavioral|follow-up calls & webinars|
16021169|NCT02730039|Behavioral|assessments|
16021170|NCT02730026|Drug|Ketoprofen|Clinical efficacy of the Ketoprofen 100 mg was study after lower third molar surgery.
16021171|NCT02730026|Drug|Ketoprofen and Omeprazole|Clinical efficacy of the Ketoprofen 200 mg and Omeprazole 20 mg will be study after lower third molar surgery.
16021172|NCT02730013|Behavioral|Square Stepping Exercise|"Square Stepping Exercise involves mimicking a stepping pattern demonstrated by an instructor. The stepping patterns become progressively difficult and involve forward, backward, lateral and diagonal movements on a 250cm long mat with 25cm square grids.
~In a group setting, an instructor will demonstrate walking patterns on a gridded mat to the participants and the participants must memorize and repeat the patterns on their own. This program has over 200 patterns that increase in difficulty from beginner to advanced. Eighty percent of the group must successfully complete the patterns to move onto the next pattern. Social engagement is encouraged."
16021173|NCT02730000|Procedure|ART with Equia|Occlusal-proximal ART restorations in primary molars using Equia (Easy/Quick/Unique/ Intelligent/Aesthetic) will be performed. No local anesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with GIC (Glass Ionomer Cement). The cavity will be filled with GIC. After the press-finger technique, the excess of material will be removed and occlusion will be checked.
16021174|NCT02730000|Procedure|ART with Riva Self Cure|Occlusal-proximal ART restorations in primary molars using Riva Self Cure will be performed. No local anesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with GIC (Glass Ionomer Cement). The cavity will be filled with GIC. After the press-finger technique, the excess of material will be removed and occlusion will be checked.
16021175|NCT02729987|Behavioral|WorkGuru|A multi-modal stress management intervention accessed over 8 weeks, incorporates CBT, positive psychology and Mindfulness. Delivered via the internet.
16021176|NCT02729974|Procedure|ROTEM|rapid testing of blood clot formation
16021177|NCT02729974|Procedure|standard treatment|visual assessment of blood loss and clotting function every 30 minutes, combined with standard laboratory testing when indicated
16021178|NCT02729961|Drug|Brentuximab Vedotin|Given IV
16021179|NCT02729961|Drug|Ceritinib|Given PO
16021180|NCT02729961|Other|Laboratory Biomarker Analysis|Correlative studies
16021181|NCT02729961|Other|Pharmacological Study|Correlative studies
16021182|NCT02729948|Other|Survey Administration|Ancillary studies
16021183|NCT02729948|Device|Tethered Capsule Endoscope|Undergo TCE
16021184|NCT02729935|Drug|Parecoxib|40 mg of intravenous parecoxib 30 min before surgery
16021185|NCT02729935|Drug|Placebo|An equal volume of saline
16021186|NCT02729922|Device|Cardiomems|Eligible patients will undergo implantation of a pulmonary artery sensor (CardioMEMS), a wireless implantable hemodynamic monitoring system in the cardiac catheterization laboratory. This system has a passive wireless, radiofrequency sensor without batteries or leads. Patients transmit data through a device in their home that interacts wirelessly with the sensor. Clinicians retrieve this data via a web interface to use in making management decisions for patients.
16021187|NCT02729909|Drug|Lubiprostone|Lubiprostone capsules
16021188|NCT02729909|Drug|Placebo|Lubiprostone placebo-matching capsules
16021189|NCT02729896|Drug|Atezolizumab [TECENTRIQ]|"Atezolizumab will be administered by intravenous (IV) infusion at a flat dose of 1200 milligram (mg) every 3 weeks (Q3W) on Day 1 of Cycles 2-6, given in 21-day cycles during induction treatment.
~NOTE: Atezolizumab treatment has been discontinued in all participants currently on study treatment."
16021190|NCT02729896|Drug|Obinutuzumab|Obinutuzumab will be administered by IV infusion at a flat dose of 1000 mg on Days 1, 8, and 15 of Cycle 1, and on Day 1 of Cycles 2-6, given in 21-day cycles during induction treatment, and on Day 1 of every other month during maintenance treatment (1 cycle=21 days; infusion rate starts at 50 mg/hour (hr) and increases every 30 min to a maximum of 400 mg/hr).
16021191|NCT02729896|Drug|Polatuzumab Vedotin|Polatuzumab vedotin will be administered by IV infusion. For relapsed or refractory FL either 1.4 mg/kilogram (kg) or 1.8 mg/kg (dose-escalation phase) and at RP2D (dose-expansion phase) on Day 1 of Cycles 1-6 will be given in 21-day cycles during induction treatment. For relapsed or refactory DLBCL, 1.8 mg/kg will be given during run-in phase and either 1.8 mg/kg or 1.4 mg/kg during the expansion phase (1 cycle=21 days; infusion rate starts with 90 min and decreases to 30 min).
16021318|NCT02728986|Device|Profore|Profore multilayer compression bandage + standard regimen for wound care according to investigator's choice
16021192|NCT02729896|Drug|Rituximab|Rituximab will be administered by IV infusion at 375 mg/m˄2 on Day 1 of Cycles 1-6 during induction treatment (1 cycle-21 days; infusion rate starts with 50 mg/hr and increases every 30 min to a maximum of 400 mg/hr).
16021193|NCT02729883|Other|Quality-of-Life Assessment|Ancillary studies
16021194|NCT02729883|Other|Questionnaire Administration|Complete interviews
16021195|NCT02729883|Procedure|Supportive Care|Receive patient navigation via the Take the Fight strategists
16021196|NCT02729870|Drug|Oral Glucose Gel|This group will receive the following: are less than 3 year of age will receive 7.5 gram oral glucose gel 40% (0.66 oz, 20ml) which will be a one time dose and the subjects who are ages 3-7 will receive 15 gram oral glucose gel (1.3 oz, 40ml) which is a one time dose.
16021197|NCT02729870|Other|Placebo|This group will receive carboxymethylcellulose (2%) oral gel. The subjects who are less than than 3 years of age will receive carboxymethylcellulose (2%) oral gel, 20ml which will be a one time dose and the subjects ages 3-7 will receive carboxymethylcellulose (2%) oral gel, 40ml which will be a one time dose.
16021198|NCT02729857|Dietary Supplement|SFA muffin|Muffin rich in saturated fat.
16021199|NCT02729857|Dietary Supplement|PUFA muffin|Muffin rich in polyunsaturated fat.
16021200|NCT02729831|Behavioral|Interactive decision aid|The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
16021201|NCT02729831|Behavioral|Video decision aid|Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis
16021202|NCT02729831|Behavioral|Provider Report|A short report that includes the patients' goals and treatment preferences
16021203|NCT02729805|Drug|Saline|10ml bolus injection of saline followed by intravenous infusion of saline during the operation
16021204|NCT02729805|Drug|Ketamine 0.5mg/kg|0.5mg/kg intravenous ketamine injection followed by 0.25mg/kg/hr intravenous ketamine infusion during the operation
16021205|NCT02729805|Drug|Ketamine 0.75mg/kg|0.75mg/kg intravenous ketamine injection followed by 0.5mg/kg/hr intravenous ketamine infusion during the operation
16021206|NCT02729792|Device|rTMS|intermittent theta burst stimulation (iTBS)
16021207|NCT02729779|Other|Pilates Group|Elderly will be submitted to a specific exercise program of modified Pilates method performed in the mat and apparatus. In the first session, participants will receive basic guidance on the Pilates training and activation of the power house. The session will be divided in: global warming and stretching (5 minutes), Pilates exercises for upper and lower limbs, abdomen and spine (45 minutes), global stretching (5 minutes) and local relaxing massage (5 minutes).The session will consist of a minimum of 5 exercises and a maximum of 15 Pilates exercises. The elderly will receive 16 individual sessions with duration of 60 minutes, twice a week, with a total of eight weeks of treatment.
16021208|NCT02729779|Other|Aerobic Group|Elderly will be submitted to an exercise program with global stretching (for lower and upper limbs and column with two repetitions and 30 seconds of maintenance in each segment) for 10 minutes, walking on a treadmill for 20 to 40 minutes, and relaxing massage for 5 minutes. The intensity of the effort during walking on a treadmill will be based on a combination of heart rate (based on the percentage of maximum heart rate: 208 - (0.7 x age)) and rate of perceived effort assessed by the Borg scale. Exercise will be performed respecting the fraction of 50-75% of maximum heart rate and levels between 12 to 13 (moderate intensity) of the Borg scale. The elderly will receive 16 individual sessions with duration of 60 minutes, twice a week, with a total of eight weeks of treatment.
16021209|NCT02729766|Other|Induced hypotonic hyponatremia - SIAD model|
16021210|NCT02729766|Drug|Empagliflozin 25mg Tbl|
16021211|NCT02729766|Drug|Placebo P-Tablet|
16021212|NCT02729753|Device|CryoBalloon™ Full Ablation System|Tissue Ablation using CryoBalloon™ Full Ablation System
16021213|NCT02729753|Device|CryoBalloon™ Swipe Ablation System|Tissue Ablation using CryoBalloon™ Swipe Ablation System
16021214|NCT02729740|Device|Penumbra Smart Coil|
16021215|NCT02729740|Device|Penumbra Coil 400TM (PC400), Penumbra Occlusion DeviceTM(POD)|Other Penumbra Coils available as standard of care
16021216|NCT02729727|Device|CryoBalloon Ablation System|Tissue Ablation using CryoBalloon Ablation System
16021217|NCT02729714|Drug|Suvorexant|10 mg Suvorexant or matching Placebo orally at bedtime with optional up-titration to 15 mg Suvorexant or matching Placebo orally at bedtime after 2 weeks.
16021218|NCT02729714|Drug|Placebo|10 mg Suvorexant or matching Placebo orally at bedtime with optional up-titration to 15 mg Suvorexant or matching Placebo orally at bedtime after 2 weeks.
16021219|NCT02729701|Drug|Duavee|Once daily tablet of Duavee (Bazedoxifene (20 mg) plus conjugated estrogen (0.45 mg))
16021220|NCT02729688|Device|customized pressure guide bandage|"Investigators developed the customized pressure guide elastic bandage (CPG-EB). The experienced nurse applied the elastic bandages to each patient with sub bandage pressure monitoring. The target pressure was 35-45 mmHg. Measurements of the pressure applied by bandages was performed at point B1 corresponding to the height where the Achilles' tendon turns into the gastrocnemius muscle with Picopress (MicroLAB Elettronica, Ponte S. Nicolo, Italy). If the target pressure 35-45 mmHg was achieved, the circular ink stamp was applied into the entire bandages. The markers in CPG-EB had elliptical shape when they were not stretched. They turned into circular shape when they were stretched.
~For the OEB, Bandaging was applied by spiral methods. Three EB were applied with 50 % stretching and 50% overlapping from foot to just below knee level."
16021221|NCT02729688|Device|Ordinary elastic bandage|Bandaging was applied by spiral methods. Three ordinary elastic bandages were applied with 50 % stretching and 50% overlapping from foot to just below knee level.
16021222|NCT02729675|Other|Access Intervention|The 7 worksites in this arm received year-round, weekly mobile F&V markets (Fresh To You - FTY) selling local and non-local fresh produce at or below local supermarket prices. The markets carried 50 to 70 different produce items and were held both indoors and outdoors depending on the weather and worksite preference. When held indoors, F&V were sold in a cafeteria or other highly trafficked area. In good weather, the markets were held outside on the worksite property in a retrofitted a car trailer. Each market lasted two hours. On average, FTY prices were 15% to 25% lower than local retail supermarket prices. Signs, posters, email blasts and flyers advertised the markets. The FTY intervention at each worksite began with a Kick-Off event, which included the first FTY market. Each employee who attended the first market received a large, reusable shopping bag with the FTY logo on it and a freezer pack to keep F&V fresh.
16021319|NCT02728986|Device|Coban2|Coban2 compression system + standard regimen for wound care according to investigator's choice
16021223|NCT02729675|Behavioral|Enhanced Intervention|The 7 worksites in this arm received the Access intervention described above as well as set of educational/behavioral interventions. At the Kick-Off, employees received the first month's newsletter and an educational digital video disk (DVD) in the reusable shopping bag. They also received a chef-run cooking demonstration/taste-testing along with recipes and information about the upcoming intervention activities. Intervention activities included two 6-week campaigns (Just Add Two and Choose Color, Choose Health); a 90 minute DVD with cooking demonstrations about preparing quick, healthy inexpensive meals and unusual F&V; a two-page, full-color newsletter distributed monthly; Food demonstrations/tastings delivered once a month by chefs including an easy to prepare, F&V-based recipe; a total of 12 recipe handouts that correlated with the monthly cooking demonstration; a Good to Go website; and a project bulletin board.
16021224|NCT02729675|Behavioral|Comparison Behavioral Intervention|Brown University contracted with the Greater Providence Young Men's Christian Association (YMCA) to provide a physical activity and stress reduction intervention at the 7 worksites in the comparison group. Two, six-week campaigns were developed jointly by the Brown study team and YMCA staff. These campaigns followed the same format as the enhanced intervention group campaigns and were provided during the same time periods as those at the enhanced intervention sites. Everyone who participated in the campaigns also received a free, 6-week membership to the YMCA.
16021225|NCT02729662|Drug|Tolvaptan|"Before administration of tolvaptan
~TKV・Liver capacity: Once/year (an additional measurement within 3 months before start of administration)
~24-hour urine collection・Hematology/urinalysis: Once/year
~Physical findings: Blood pressure and medical interview at ambulatory visit
~Hospitalization for education and examination at the start of tolvaptan administration
~24-hour urine collection・Hematology/urinalysis・Inulin clearance
~Physical findings: Body weight, blood pressure
~Adverse Events
~After administration of tolvaptan
~TKV・Liver capacity・inulin clearance: Once/year
~24-hour urine collection: Once/6 months
~Hematology/urinalysis: Once/month in principle
~Physical findings: Blood pressure and medical interview at ambulatory visit
~Adverse Events"
16021226|NCT02729649|Device|ArmAssist robotic training|
16021227|NCT02729649|Other|Conventional therapy|
16021228|NCT02729649|Other|Extended conventional therapy|
16021229|NCT02729636|Device|multi-pad functional electrical stimulation (FES)|"Treatment includes two automated phases: optimization of stimulation parameters and application during the walk.
~Optimization of stimulation parameters: The stimulator generates short bursts of electrical impulses and sends them to each of the 16 pads of the multi-pad electrode. Each pad is the same size. Pads are sorted in two rows by 8 pads. Common anode is placed under the knee. Based on FES-induced foot movements, automated algorithm suggests parameters which are evaluated by medical doctor/therapist.
~Assisted walking: During assisted walking, pattern for plantar flexion is activated in push off phase and pattern for dorsiflexion in swing phase of the gait."
16021230|NCT02729636|Other|Conventional therapy|2. All study subjects received the conventional stroke rehabilitation program of physiotherapy based on the neurodevelopmental facilitation approach and occupational therapy focused on activities of daily living during the treatment for 60 min a day, 5 days a week, for 4-weeks. Conventional therapy was given by trained therapists and consisted of the following strategies: strategies to joint mobilization and range of motion exercises; exercises to improve strength; strategies to manage spasticity; exercises for increase range of motion, compensatory strategy; strategies to improve balance, and mobility.
16021231|NCT02729623|Drug|Kite Systems cannaHALER cannabis Inhaler.|
16021232|NCT02729610|Device|double-lumen endotracheal tube (DLT group)|In this arm, after anesthesia induction, a double lumen endotracheal tube will be intubated for one-lung ventilation
16021233|NCT02729610|Device|endobronchial blocker (BB group)|In this arm, after anesthesia induction, an endobronchial blocker will be intubated for one-lung ventilation
16021234|NCT02729597|Other|medical history|The complete medical history (including cardiovascular risk factors and medication) will be assessed at baseline and follow-up.
16021235|NCT02729597|Other|neurological clinical examination|Neurological examination will be performed at baseline and follow-up.
16021236|NCT02729597|Other|neuropsychological testing|Neuropsychological testing using a 13 item test battery will be performed at baseline and follow-up.
16021237|NCT02729597|Other|brain MRI|Brain MRI ( 3.0 T) will be performed using the same hard- and software at baseline and follow-up.
16021238|NCT02729571|Biological|MTBVAC|Live-attenuated tuberculosis vaccine
16021239|NCT02729571|Biological|BCG|Commercially available live-attenuated tuberculosis vaccine
16021240|NCT02729558|Radiation|local SRT|local stereotactic radiotherapy in three fractions of 8 Gy to the surgical cavity
16021241|NCT02729545|Other|Tung's acupuncture|The study took Tung's acupoints as main acupuncture points, which were Fuke, Huanchao, Tianhuang, Renhuang, as well as the traditional acupoints Guanyuan (CV4) and Zigong (EX-CA1).
16021242|NCT02729545|Drug|Cyproterone acetate/ethinylestradiol (CPA/EE)|Cyproterone acetate/ethinylestradiol (CPA/EE) contains 2mg cyproterone acetate (an anti-androgenic progestin) and 0.035mg ethinylestradiol (CPA/EE). The pills were administered for 21 days consecutively. The patients then stopped taking the pills for seven days and, on the eighth day, continued to take the pills again for three menstrual cycles (28 day cycles).
16021243|NCT02729532|Device|Xpert|The Xpert MTB/RIF assay is a nucleic acid amplification (NAA) test that uses a disposable cartridge with the GeneXpert Instrument System
16021244|NCT02729519|Procedure|TAVI|standard procedure TAVI performed with systematic pre dilatation (With prior balloon dilatation) (ARM A) ou without pre dilatation (ARM B)
16021245|NCT02729506|Procedure|Transarterial Radioembolization|Yttrium-90 radioembolization (90Y) is a relatively new technique involving the trans-arterial administration of glass or resin microspheres loaded with Yttrium-90, a β-emitting isotope, delivering selective internal radiation to the tumor.
16021246|NCT02729506|Procedure|Transarterial Chemoembolization using drug-eluting beads|"TACE is a procedure in which a catheter is introduced into the branches of the hepatic artery supplying the tumor. Embolic material and chemotherapeutic agents are deployed through the catheter directly into the tumor vasculature. This technique potentially enhances the cytotoxic effect by inducing ischemia and retention of the therapeutic agent in the vicinity of the tumor.
~The drug-eluting beads (DEBs) enable standardization of TACE since DEBs act as both an occluding agent as well as a drug-loaded carrier, achieving local ischemia and cytotoxic death of the tumor with one device."
16021361|NCT02728674|Other|Person in the case is a female.|Person in the case is a female.
16021247|NCT02729493|Biological|EPCAM-targeted CAR-T cells|This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-EPCAM-modified T cells can recognize and kill tumor cells in the body，follow-up 35 months.
16021248|NCT02729480|Device|Halo Craniofacial Nerve Stimulator System|The Halo Craniofacial Nerve Stimulator System is a wirelessly powered neurostimulator for pain in the face or head (not for headaches or migraine). This technology includes an implanted stimulator with an embedded receiver. The energy source is a small, external, rechargeable transmitter, which is worn by the patient. The transmitter sends the therapy program and power through the skin to the receiver.
16021249|NCT02729467|Drug|JNJ-53718678|JNJ-53718678 will be applied twice at doses of 250 mg (in Panel 1, Day 1 and Day 9) and 3 times at 500 mg (Panel 2, Day 1, 4 and 9).
16021250|NCT02729467|Drug|Itraconazole|Participants will receive itraconazole 200 mg (2 capsules of 100 mg) from Day 4-11.
16021251|NCT02729467|Drug|Rifampicin|Participants will receive 600 mg rifampicin (2 capsules of 300 mg) from Day 4-11.
16021252|NCT02729454|Other|Mental practice and physical therapy|
16021253|NCT02729454|Other|physical therapy|
16021254|NCT02729441|Drug|ramipril|Comparison of two renin angiotensin aldosterone inhibitors
16021255|NCT02729441|Drug|perindopril|Comparison of two renin angiotensin aldosterone inhibitors
16021256|NCT02729428|Device|MRI|Participants will undergo an MRI scan
16021257|NCT02729415|Procedure|Stromal Vascular Fraction Cells (SVF Cells) Injection|The procedure involves the injection of stromal vascular fraction cells (SVF Cells) into the scalp. The injection will be performed once in the middle of two perpendicular sides of a 2 x 2 cm area.
16021258|NCT02729415|Procedure|Liposuction|Tissue collection involving the micro-harvest of subcutaneous adipose tissue to harvest the stromal vascular fraction cells (SVF Cells).
16021259|NCT02729415|Other|Hair Measurements|Hair measurements will be performed using a computerized handheld USB camera at baseline, 6 weeks, and months 3 and 6 after treatment.
16021260|NCT02729402|Other|Cognitive Testing|We will use a battery of neurocognitive tests to assess cognitive function before and after surgery
16021261|NCT02729389|Behavioral|High Social Status Condition|Participants will be provided with a high degree of privilege in a game of Monopoly.
16021262|NCT02729389|Behavioral|Low Social Status Condition|Participants will be provided with a low degree of privilege in a game of Monopoly.
16021263|NCT02729376|Drug|galeterone|
16021264|NCT02729363|Behavioral|Guided Relaxation video clip|This intervention is a 12-minute guided audio-visual relaxation intervention.
16021265|NCT02729363|Behavioral|Sickle Cell Disease Experience Discussion|This intervention is a 12-minute computer-administered sickle cell disease experience discussion.
16021266|NCT02729350|Behavioral|Guided Relaxation video clip|This intervention is a 12-minute guided relaxation intervention for reducing pain and stress in adult inpatients with sickle cell disease.
16021267|NCT02729350|Behavioral|Sickle Cell Disease Experience Discussion|This intervention is a 12-minute sickle cell disease experience discussion.
16021268|NCT02729337|Behavioral|ITG (In This Together)|Comprehensive, mHealth-based HIV prevention program for Ugandan adolescents 18-22 years of age.
16021269|NCT02729324|Drug|Medical Radiation Protectants (FORRAD®)|Medical Radiation Protectants (FORRAD®) is prescribed at the beginning of radiotherapy for free. Patients are asked to start topical application of Medical Radiation Protectants (FORRAD®) on irradiated skin at the onset of radiotherapy, three times a day (30 minutes before radiotherapy, after radiotherapy, and before bedtime), until completion of their radiotherapy. All patients will receive conventional health education and medical care for prevention and treatment of radiation dermatitis. When grade 2 or higher radiation dermatitis is developed, patients can continue using Medical Radiation Protectants (FORRAD®). When grade 3 or higher radiation dermatitis happened, other interventions, such as prophylactic or therapeutic antibacterial therapy, will be used, and radiotherapy should be interrupted, until moist desquamation is cured.
16021270|NCT02729324|Drug|Trolamine (Biafine)|Trolamine (Biafine) is prescribed at the beginning of radiotherapy. Patients are asked to start topical application of trolamine (Biafine) on irradiated skin at the onset of radiotherapy, three times a day, until completion of their radiotherapy. All patients will receive conventional health education and medical care for prevention and treatment of radiation dermatitis. No other prophylactic creams, lotions, or gels are allowed. When grade 2 or higher radiation dermatitis is developed, patients cannot use trolamine any more, and they will receive other conventional medical care for treatment of radiation dermatitis in the investigators institution. When grade 3 or higher radiation dermatitis happened, other interventions, such as prophylactic or therapeutic antibacterial therapy, will be used, and radiotherapy should be interrupted, until moist desquamation is cured.
16021271|NCT02729311|Behavioral|Paired PLIÉ Program|The Paired PLIÉ Program is a novel, multimodal, movement program that focuses on abilities that are well maintained in people with dementia, including training procedural ('muscle') memory for basic daily movements, in-the-moment mindful body awareness, and social engagement. Group classes are held with affected individuals, care partners and instructors together. A monthly home visit also is provided.
16021272|NCT02729298|Drug|TP-0903|Novel oral inhibitor that targets AXL kinase and reverses the mesenchymal phenotype associated with advanced cancers
16021273|NCT02729285|Drug|Ketorolac Tromethamine|On operation day, the patients were randomly assigned to receive intramuscular Ketorolac 60-mg 30 min before scleral buckle surgery.
16021274|NCT02729285|Drug|placebo|On operation day, the patients were randomly assigned to receive placebo 30 min before scleral buckle surgery.
16021275|NCT02729285|Procedure|scleral buckle|Surgical procedure of scleral buckle under retrobulbar block anesthesia
16021276|NCT02729272|Procedure|Laparoscopic colpotomy by ultrasonic ESD|In this intervention, laparoscopic colpotomy was performed by ultrasonic ESD (Harmonic Synergy Hook Blades; Ethicon Endo-Surgery, Cincinnati, OH, USA).
16021277|NCT02729272|Procedure|Laparoscopic colpotomy by monopolar ESD|In this intervention, laparoscopic colpotomy was performed by monopolar ESD (hook electrode with 90 watts of unmodulated current; Karl Storz, Tuttlingen, Germany).
16021278|NCT02729272|Device|Monopolar ESD|
16021279|NCT02729272|Device|Ultrasonic ESD|
16021280|NCT02729259|Behavioral|Virtual Reality Snowworld|The subjects will receive Virtual Reality Snowworld during their wound care procedure. The nurse will be doing their wound care.
16021281|NCT02729259|Behavioral|Virtual Reality slides of nature|The subjects will receive Virtual Reality Slides of Nature during their wound care procedure. The nurse will be doing their wound care.
16021282|NCT02729259|Behavioral|Control standard nurse wound care|The subjects will receive their standard care during wound care. The nurse will be doing the wound care.
16021283|NCT02729246|Procedure|Laparoscopic Gastric Bypass|
16021284|NCT02729233|Other|patients receiving biopsies|Six mucosal biopsies will be collected from each site (terminal ileum and rectum) for histologic verification of pCLE findings at baseline, and again at month 12 for a total of 12 research samples per colonoscopy, or 24 research biopsy samples during the course of the study. The study subjects will be followed for a total of 1 year after initial colonoscopy with pCLE. The primary study end-point is clinical response at 3 months following initiation of golimumab.
16021285|NCT02729220|Other|Bronchoscopy|Sampling of airways
16021287|NCT02729194|Drug|Pazopanib|
16021288|NCT02729194|Other|Low Fat Diet|Registered subjects will take pazopanib by mouth with a low-fat meal (containing less than 400 calories and less than 10% fat or 10 grams per meal.
16021289|NCT02729181|Device|DRX9000|
16021290|NCT02729168|Biological|Human rabies vaccine|
16021291|NCT02729155|Procedure|RIPre|Preconditioning 200 mmHg x 5 minutes before procedure
16021292|NCT02729155|Procedure|RIPost|Postconditioning 200 mmHg x 5 minutes after procedure
16021293|NCT02729155|Procedure|Sham-Pre|Sham 10 mmHg x 5 minutes before procedure
16021294|NCT02729155|Procedure|Sham-Post|Sham 10 mmHg x 5 minutes after procedure
16021295|NCT02729142|Procedure|Tibial cortical density evaluation|Bone evaluation in transplant patients will be performed by HR-pQCT at baseline (either within 6 months before surgery or within 15 days following surgery) and 6 months post-intervention in order to assess its evolution.
16021296|NCT02729129|Other|Diesel exhaust exposure with filtered facemask|1 hour exposure to dilute diesel exhaust (approximate particle matter concentration 300 mcg/m3) during intermittent exercise while wearing a filtered facemask.
16021297|NCT02729129|Other|Diesel exhaust exposure with sham mask|1 hour exposure to dilute diesel exhaust (approximate particle matter concentration 300 mcg/m3) during intermittent exercise while wearing a sham facemask.
16021298|NCT02729116|Drug|Sitafloxacin|Patients are given intravenous empirical antibiotics for 3 days. The patients are allocated to the sitafloxacin group or ertapenem group using of a computer-generated random number allocation schedule and block size of four.
16021299|NCT02729116|Drug|Ertapenem|Patients are given IV ertapenem for 14 days
16021300|NCT02729103|Drug|Xofigo (Radium 223 dichloride,BAY88-8223)|Retrospective claims analysis. Descriptive analyses of treatment patterns.
16021301|NCT02729090|Other|Device: treadmill|Aerobic training on a treadmill continuously with speed and wave periodization. Frequency twice per week ( 2x ) for twelve weeks. Device: treadmill.
16021302|NCT02729090|Other|Device: treadmill Train_Comb_aerobic|Device: treadmill Train_Comb_aerobic. strength training with free weights, followed by active recovery on a treadmill with fixed intervals of 60 to 120 seconds between each workforce of series. Device: treadmill Train_Comb_aerobic
16021303|NCT02729077|Device|Pulse Oximetry|Use of pulse oximetry device for 48 hours after surgery.
16021304|NCT02729064|Drug|Humulin R|Study subjects will receive intranasal insulin (Humulin R) via a metered nasal dispenser.
16021305|NCT02729064|Drug|Normal Saline|Study subjects will receive intranasal placebo (normal saline) via a metered nasal dispenser.
16021306|NCT02729051|Drug|FF/UMEC/VI|This intervention is provided in two strips. First strip contains FF blended with lactose. It is available as dry white powder, 100 mcg per blister. Second strip contains UMEC and VI blended with lactose and magnesium stearate. It is available as dry white powder, 62.5 mcg per blister UMEC, 25 mcg per blister VI. The intervention is inhaled via the DPI, once daily in the morning. DPI contains 30 doses (2 strips with 30 blisters per strip).
16021307|NCT02729051|Drug|FF/VI|This intervention is provided in two strips. First strip contains FF blended with lactose. It is available as dry white powder, 100 mcg per blister. Second strip contains VI blended with lactose and magnesium stearate. It is available as dry white powder, 25 mcg per blister. The intervention is inhaled via the DPI, once daily in the morning. DPI contains 30 doses (2 strips with 30 blisters per strip).
16021308|NCT02729051|Drug|UMEC|This intervention is available in one strip. The strip contains UMEC blended with lactose and magnesium stearate. The formulation is available as dry white powder, 62.5 mcg per blister. The intervention is inhaled via the DPI, once daily in the morning. DPI contains 30 doses (1 strip with 30 blisters).
16021309|NCT02729051|Drug|Placebo|This intervention is available in one strip. The strip contains lactose. The formulation is available as dry white powder. The intervention is inhaled via the DPI, once daily in the morning. DPI contains 30 doses (1 strip with 30 blisters).
16021310|NCT02729051|Drug|Albuterol/salbutamol|This is a rescue medication administered via metered-dose inhaler (MDI) with a spacer which will be used when needed during the study.
16021311|NCT02729038|Drug|Gepotidacin|Gepotidacin after reconstitution is a clear, dark brown to dark brownish-yellow solution, free from visible particulate matter. Subjects will receive gepotidacin 750 mg single IV dose over 2 hours.
16021312|NCT02729025|Drug|Evolocumab|Administered subcutaneously once a month using an autoinjector/pen.
16021313|NCT02729025|Drug|Placebo|Administered subcutaneously once a month using an autoinjector/pen.
16021314|NCT02729012|Drug|hypertonic saline solution (NACL 3%+NAHCO3)|Treatment with nebulized hypertonic saline solution (NACL 3%+NAHCO3)
16021315|NCT02729012|Other|Saline Solution (NACL 0,9%)|Treatment with nebulized Saline Solution (NACL 0,9%)
16021316|NCT02728999|Procedure|Steep Trendelenburg|"•Subjects who undergo steep Trendelenburg will remain in 30 degrees of Trendelenburg, and the da Vinci robot will be docked.
~After subjects are asleep an arterial line will be place in one wrist by the anesthesiologist. It will be removed at the conclusion of the procedure."
16021317|NCT02728999|Procedure|Decreased Trendelenburg|"•Subjects who undergo decreased Trendelenburg will be taken out of Trendelenburg to the minimal angle possible that enables adequate visualization, as determined by the primary surgeon, at which time robot will be docked.
~After subjects are asleep an arterial line will be place in one wrist by the anesthesiologist. It will be removed at the conclusion of the procedure."
16021362|NCT02728674|Other|Symptom in the case is breathlessness.|Symptom in the case is breathlessness.
16021320|NCT02728973|Other|ERAS program|The main elements of this program were: preoperative advice, no colon preparation, provision of carbohydrate-rich drinks one day prior and on the morning of surgery, goal directed fluid administration, body temperature control during surgery, avoiding drainages and nasogastric tubes, early mobilization, and the taking of oral fluids in the early postoperative period.
16021321|NCT02728960|Procedure|MRI of the Brain (No Contrast) Scan|DSI data will be acquired on 3T Tim Trio System (Siemens) using a 32-channel coil
16021322|NCT02728947|Drug|ROTIGOTINE|1 week at each dose
16021323|NCT02728934|Biological|Golimumab Intravenous (IV)|This is an observational study. Patients who will receive golimumab IV will be observed for 3 years.
16021324|NCT02728934|Biological|Infliximab|This is an observational study. Patients who will receive infliximab will be observed for 3 years.
16021325|NCT02728934|Biological|Biosimilar Infliximab|This is an observational study. New patients who will receive biosimilar infliximab will be observed for 3 years (maximum). Biosimilar Infliximab patients will be included in Exploratory analyses only and will not be included in Primary or Secondary outcome measures analyses.
16021326|NCT02728921|Drug|5% Albumin infusion 30 min|Intravenous infusion of 5% Albumin at a dose of 10 ml/kg during 30 minutes. Dose is based on ideal weight.
16021327|NCT02728921|Drug|5% Albumin infusion 3 hours|Intravenous infusion of 5% Albumin at a dose of 10 ml/kg during 3 hours. Dose is based on ideal weight.
16021328|NCT02728908|Device|Medfield Strokefinder MD100|Measurement with Medfield Strokefinder MD100
16021329|NCT02728895|Drug|Vedolizumab|Vedolizumab Injection.
16021330|NCT02728882|Biological|CD19-targeted CAR-T cells|This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-CD19-modified T cells can recognize and kill tumor cells in the body，follow-up 35 months.
16021331|NCT02728869|Biological|Heat Stable Rotavirus (HSRV) Vaccine|It is a lyophilized live attenuated pentavalent (G1-G4 and P1[8]) heat-stable rotavirus vaccine (HSRV) comprising of all the five rotavirus strains as in licensed RotaTeq® vaccine for protection against rotavirus infection
16021332|NCT02728869|Biological|Placebo for Heatstable Rotavirus vaccine|It is a lyophilized formulation comprising of all the inactive ingredients as in heat stable rotavirus vaccine without any rotavirus
16021333|NCT02728869|Biological|RotaTeq®|It is a pentavalent human-bovine (WC3) reassortant live-attenuated, oral vaccine developed by Merck Research Co., West Point, Pennsylvania, USA. This vaccine contains five live reassortant rotaviruses. Four reassortant rotaviruses express the VP7 protein (G1, G2, G3, or G4) from the human rotavirus parent strain and the attachment protein (P7[5]) from bovine rotavirus parent strain WC3. The fifth reassortant virus expresses the attachment protein (P1A[8]) from the human rotavirus parent strain and the outer capsid protein G6 from the bovine rotavirus parent strain.
16021334|NCT02728856|Other|Sunscreen Spray SPF50 Z15-034(BAY987516)|Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.
16021335|NCT02728856|Other|Shampoo Control|Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.
16021336|NCT02728856|Other|Sunscreen Spray SPF50 Z15-038(BAY987516)|Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.
16021337|NCT02728843|Drug|Deferiprone|600 mg tablets
16021338|NCT02728843|Drug|Placebo|Tablets that match the deferiprone tablets in appearance
16021339|NCT02728830|Drug|Pembrolizumab|Pembrolizumab 200mg IV
16021340|NCT02728817|Procedure|End-cephalic vein to side-radial artery fistula creation|"Circumferential dissection of the cephalic vein (4-5cm long)
~Longitudinal arteriotomy (~10mm)
~End-vein to side-artery anastomosis using 7-0 polypropylene continuous suture"
16021341|NCT02728817|Procedure|RADAR fistula creation|"Dissection of the anterior-medial aspect of the cephalic vein (~15mm) without grasping or clamping the venous wall
~Circumferential dissection of the radial artery pedicle (5cm long) and ligation of collaterals with surgical microclips
~Ligation and section of the radial artery (distal)
~Longitudinal venotomy (~10mm)
~End-artery to side-vein anastomosis using 7-0 polypropylene continuous suture"
16021342|NCT02728804|Other|Quality-of-Life Assessment|Complete questionnaire
16021343|NCT02728804|Other|Questionnaire Administration|Complete questionnaires
16021344|NCT02728778|Drug|incobotulinumtoxin A|Application of botulinum toxin A into the forehead
16021345|NCT02728778|Procedure|Acupuncture|Application of acupuncture into the forehead
16021346|NCT02728765|Device|Continuous positive airway pressure (CPAP)|Continuous positive airway pressure (CPAP) is the gold standard treatment for patients with obstructive sleep apnea (OSA). In a previous trials comparing therapeutic CPAP vs subtherapeutic CPAP, CPAP could reduce 24-hour mean blood pressure in mildly sleepy patients with OSA over 3 months whereas our one-year prospective study has shown that reduction of carotid artery intima-media thickness of OSA patients occurred mostly in the first 6 months and was sustained at 12 months in patients with CPAP compliance about 4.7 hours per night.
16021347|NCT02728752|Drug|Octagam 10%|Patients to be treated with Octagam 10%
16021348|NCT02728752|Other|Placebo|Patients to be treated with a Placebo
16021349|NCT02728739|Procedure|Transthoracic Echocardiogram (TTE) Assesment|Transthoracic Echocardiogram (TTE) will be carried out on all heart failure patients with elevated BNP level (>30 pg/ ml) for grading of MR severity within 7 days.
16021350|NCT02728726|Drug|sugammadex|
16021351|NCT02728726|Drug|Placebo|
16021352|NCT02728713|Procedure|Cranial Manipulation|Performed by exaggerating the motion asymmetry with a minimum of pressure (a few ounces) and holding the position until the motion becomes symmetrical.
16021353|NCT02728713|Procedure|Sham/Placebo|A laying on of hands with no actual treatment being performed.
16021354|NCT02728700|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo HSCT
16021355|NCT02728700|Other|Laboratory Biomarker Analysis|Correlative studies
16021356|NCT02728700|Drug|Mycophenolate Mofetil|Given IV
16021357|NCT02728700|Drug|Sirolimus|Given PO
16021358|NCT02728687|Drug|Mannitol|Apply cream as needed up to 4 times daily to the painful foot and leg
16021359|NCT02728687|Drug|Menthol|Apply cream as needed up to 4 times daily to the painful foot and leg
16021360|NCT02728674|Other|Person in the case is a male.|Person in the case is a male.
16021363|NCT02728674|Other|Symptom in the case is pain.|Symptom in the case is pain.
16021364|NCT02728661|Behavioral|PACE|PACE is an 14 week behavioral weight loss intervention developed specifically for knee replacement patients that starts up to 6 weeks prior to surgery.
16021365|NCT02728661|Behavioral|Delayed PACE|Delayed PACE is an 14 week behavioral weight loss intervention developed specifically for knee replacement patients that starts 12 weeks after surgery.
16021366|NCT02728648|Drug|Oxycodone|Pain Management
16021367|NCT02728635|Other|Dual-energy X-ray absorptiometry (DEXA)/ Magnetic resonance imaging (MRI) and Magnetic resonance spectroscopy (MRS)|A DEXA scan for body composition will also be completed. After a MRI safety screening a whole body MRI for the volumetric measurement of visceral fat, subcutaneous fat, liver, kidneys, heart, brain, skeletal muscle and intramuscular adipose tissue (IMAT) and hepatic lipid by MRS will be performed. Whole body imaging will include low resolution positioning images, followed by several sets of 3D images which will be digitally connected to create a 3D image the entire length of the body. The liver spectroscopy will be performed using PRESS (point resolved spectroscopy) and STEAM (Stimulated Echo Acquisition Mode) sequence during the same imaging session, using the whole body images for positioning.
16021368|NCT02728635|Procedure|Adipose tissue biopsies|Two biopsies will be performed to collect fat tissue from the abdomen and thigh region.
16021369|NCT02728635|Other|FSIGTT/ RMR|Insertion of two intravenous (IV) catheters for performing a Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT) to measure the acute insulin response to glucose (AIRg) and insulin sensitivity (Si) will be performed. Resting metabolic rate (RMR) will be used to measure metabolic flexibility. Point of care blood glucose measurements will be taken frequently to ensure safety.
16021370|NCT02728622|Drug|Tamoxifen|endocrine treatment
16021371|NCT02728622|Drug|Chemotherapy|Paclitaxel or pegylated liposomal doxorubicin
16021372|NCT02728609|Device|ABThera vacuum device|This intervention uses a commercially available vacuum device to temporarily close the abdomen following surgery.
16021373|NCT02728609|Device|Blue towel: vacuum pack device|This intervention uses operating room towels and the application of suction to temporarily close the abdomen following surgery.
16021374|NCT02728596|Other|Preventive Intervention|Receive PP-CSF
16021375|NCT02728596|Other|Quality-of-Life Assessment|Ancillary studies
16021376|NCT02728596|Other|Questionnaire Administration|Ancillary studies
16021377|NCT02728583|Dietary Supplement|Margarine enriched with plant sterols and fish oil|
16021378|NCT02728583|Dietary Supplement|Placebo margarine|
16021379|NCT02728570|Other|High Dietary Flavonoids|A prepared diet consisting of whole foods with a macronutrient composition of 17% en from protein, 30% en from fat and 53% energy from carbohydrate and containing high levels of dietary flavonoids including anthocyanins, flavanones, flavan-3-ols, flavonols, flavones, and polyflavonoids.
16021380|NCT02728570|Other|Low Dietary Flavonoids|A prepared diet consisting of whole foods with a macronutrient composition of 17% en from protein, 30% en from fat and 53% energy from carbohydrate and containing low levels of dietary flavonoids including anthocyanins, flavanones, flavan-3-ols, flavonols, flavones, and polyflavonoids.
16021381|NCT02728557|Behavioral|Supportive-Expressive Therapy|Supportive-expressive psychotherapy for depressive disorder for 16 weeks.
16021382|NCT02728557|Behavioral|Supportive Therapy|Supportive psychotherapy for depressive disorder for 16 weeks.
16021383|NCT02728544|Other|exercise and blood tests|At an initial one-hour meeting study participants will learn to perform aerobic (treadmill) exercise and resistance training under the supervision of an experienced exercise physiologist. Exercise intensity will be assessed by direct measurement of VO2 m
16021384|NCT02728531|Drug|Bendamustine|
16021385|NCT02728531|Drug|Rituximab|
16021386|NCT02728531|Drug|Cytarabine|
16021387|NCT02728531|Drug|Pegfilgrastim|
16021388|NCT02728531|Procedure|Leukapheresis|
16021389|NCT02728531|Drug|Filgrastim|
16021390|NCT02728531|Procedure|Autologous stem cell transplant|
16021391|NCT02728518|Drug|Nebulized Amikacin|400mg twice daily nebulized amikacin
16021392|NCT02728518|Drug|Intravenous Amikacin|20mg/kg once daily intravenous amikacin
16021393|NCT02728505|Drug|SinuSurf irrigation twice daily|
16021394|NCT02728505|Drug|NeilMed Sinus rinse irrigation twice daily|
16021395|NCT02728492|Drug|Quisinostat|
16021396|NCT02728492|Drug|Paclitaxel|
16021397|NCT02728492|Drug|Carboplatin|
16021398|NCT02728492|Drug|Gemcitabine|
16021399|NCT02728492|Drug|Cisplatin|
16021400|NCT02728466|Dietary Supplement|Flavanol and procyanidin supplement|Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing flavanols (monomers) and procyanidins (dimers to decamers)
16021401|NCT02728466|Dietary Supplement|Procyanidin-containing supplement|Sustained intake (2x daily over 1 month) of a cocoa-based supplement containing procyanidins (dimers to decamers)
16021402|NCT02728466|Dietary Supplement|control supplement deprived of flavanols and procyanidins|Placebo comparator: flavanol and procyanidin deprived supplement Sustained intake (2x daily over 1 month) of a macro-and micronutrient matched supplement
16021403|NCT02728453|Drug|Empagliflozin|Treatment with empagliflozin vs. glimepiride to understand whether empagliflozin may reduce left ventricular mass in patients with type 2 Diabetes mellitus.
16021404|NCT02728453|Drug|Glimepiride|Treatment with empagliflozin vs. glimepiride to understand whether empagliflozin may reduce left ventricular mass in patients with type 2 Diabetes mellitus.
16021405|NCT02728440|Drug|human chorionic gonadotropin, human menopausal gonadotropin|drug for the treatment of male hypogonadism
16021406|NCT02728427|Device|Suprapubic catheterization using central venous catheter(CVC-2 7F)|Suprapubic catheterization using central venous catheter(CVC-2 7F) will be performed for patients after laparoscopic surgery for rectal cancer.Suprapubic catheterization is inserted at the end of the procedure. It will be clamped depending on surgeon's specific instruction and removed if the urinary residual is less than 50 cc.
16021407|NCT02728427|Device|Transurethral catheterization using Foley catheter|Traditional transurethral catheterization using Foley catheter will be performed for patients.The catheterization is removed on day 5 in patients without complication.
16021408|NCT02728414|Dietary Supplement|probiotics|the patients in this arm will receive probiotics with a dose for 2g/d for 3 months.
16094539|NCT02203500|Drug|Telmisartan|
16021409|NCT02728414|Dietary Supplement|placebo|the patients in this arm will receive placebo intervention
16021410|NCT02728388|Drug|aminolevulinic acid|"Drug: Levulan Kerastick
~Drug: Topical placebo
~Device: Omnilux Revive
~Procedure: Photodynamic therapy
~Other: Tumor growth rate measurements"
16021411|NCT02728375|Other|computer game based rehabilitation protocol|Participants who consent to take part in the study will be asked to use objects instrumented with the miniature motion mouse to play various therapeutic yet entertaining games while handling and moving the test therapeutic objects as a part of experimental therapy protocol. The objects used will be everyday items; a) lifting/rotating a sports ball small beach ball which requires bimanual handling, b) rolling a cylinder object (diameter 6-10 cm with fingers extended and using elbow and shoulder motion, c) grasping grasp small glass and then a sponge ball with whole hand and rotating (supination- pronation motion) d) motion of a small wand (pencil) with 3-finger pinch grip and using hand-wrist motion, and e) turning of a key with 2-finger pinch fine finger control. These objects represent a wide range of physical properties requiring different modes of manipulation and functional demands sufficient to test the assessment tool.
16021412|NCT02728375|Other|Conventional therapy protocol|In control group: 1) Stretching of Biceps, Lattisimusdorsi, Pronators, Thumb muscles. 2) Weight Bearing Exercises. 3) CIMT for 20 min per day for 3-4 weeks, repeat each task 15-20 times. Pegboard activities, Rings: reaching- removing and putting back, Ball throw (under and over arm) - at basket which is kept 10 to 15 meter distance, opening bottle cap (large size bottle), Opening and closing door handle activity, Holding water bottle, bag in hand and transfer to 10 to 20 meter distance, Crumbling paper, Clay activities, Picking marbles from sand 4)Hand arm bimanual activities: Throwing ball with both hands, Holding ball with both hands and transfer, Holding bolster and keeping at place, Holding notebook in both hands, Holding rack with both hands, Holding plate in one hand and spoon in other hand, Pushing door or wall both hands.
16021413|NCT02728349|Drug|Chlorogenic acid|Chlorogenic acid for injection is polyphenols, micromolecular and un-endogenous substance. It might play the role of cancer treatment via balancing tumor micro-environmental immune status according to the stability and rationality of immunodeficiency and endogenous immune material expression around the tumor. Chlorogenic acid for injection is made from chlorogenic acid (purity≥98%) which is extracted from folium cortex eucommiae.Chlorogenic acid and its preparations have not been reported as chemical drug and marketed around the world.
16021414|NCT02728336|Procedure|Cardiac MRI|
16021415|NCT02728323|Drug|Levobupivacaine|100 mg of Levobupivacaine by intramuscular injection, at the end of surgery
16021416|NCT02728323|Drug|Saline|20 ml of saline saline by intramuscular injection, at the end of surgery
16021417|NCT02728310|Drug|Levobupivacaine|An infusion rate of 10 ml/h of 1500 mg of 0.5 % of levobupivacaine for the first 30 h and 5 ml/h for the second 30 h (LCWI) were injected into the surgical wound.
16021418|NCT02728310|Drug|Saline|An infusion rate of 10 ml/h of 300 ml of saline solution for the first 30 h and 5 ml/h for the second 30 h (LCWI) were injected into the surgical wound.
16021419|NCT02728297|Procedure|Staged ETS|Thoracoscopic approach of sympathetic ganglia T3-T12 on one side, retraction of the diaphragm and lung laterally to expose the ganglia then ablation of each ganglion using electrocauterization.
16021420|NCT02728284|Procedure|cardiovascular MRI (CMR)|CMR is used to demonstrate cardiac abnormalities and assess cardiac function in many patients
16021421|NCT02728284|Procedure|Conventional Cardiologic Evaluation|ECG (gating), and respiratory motion effects
16021422|NCT02728271|Biological|HPC cell infusion|"Administration of total lymphatic irradiation, antithymocyte globulins, and high dose cyclophosphamide, followed by the infusion of autologous stem cells.
~Patients will not receive any cyclosporin A, rituximab, or azathioprine post transplant."
16021423|NCT02728258|Drug|Copanlisib|Given IV
16021424|NCT02728258|Other|Laboratory Biomarker Analysis|Correlative studies
16021425|NCT02728245|Drug|Dienogest|Dienogest 2mg po qd
16021426|NCT02728245|Drug|Placebo drug|Placebo 1 table po qd
16021427|NCT02728245|Procedure|Surgery|conservative surgery without intent to oophorectomy
16021428|NCT02728232|Procedure|internal iliac artery ligation|
16021429|NCT02728232|Procedure|Cesarean Hysterectomy|
16021430|NCT02728219|Procedure|TACE|In this study we prospectively select some early diagnosed recurrent HCC patients after radical resection with AFP conversion, then they will be treated with transcatheter arterial chemoembolization (TACE)
16021431|NCT02728219|Procedure|Hepatectomy|Repeat Hepatectomy after postoperation recurrence
16021432|NCT02728206|Drug|SOF/VEL|400/100 mg FDC tablet administered orally once daily
16021433|NCT02728193|Procedure|RFA|
16021434|NCT02728193|Procedure|MWV|
16021435|NCT02728193|Procedure|PEI|Percutaneous ethanol injection
16021436|NCT02728180|Drug|Xingnaojing injection|Xingnaojing injection (20 ml), IV (in the vein), every 12 hours for 10 days.
16021437|NCT02728180|Other|Standard care|Guidelines-based standard care for acute ischemic stroke.
16021438|NCT02728167|Device|Pre-coagulation of the liver parenchyma with HIFU|6 to 10 (or more if necessary) side-to-side 40-seconde HIFU treatments
16021439|NCT02728154|Other|Blood Sample|One tablespoon of blood will be drawn once during the study.
16021440|NCT02728154|Other|Stool Sample|One stool sample will be collected.
16021441|NCT02728141|Other|Water|2 ml distilled water by syringe one time in the newborn's mouth 2 minutes before heel stick
16021442|NCT02728141|Other|Sucrose|2 ml 25% sucrose in distilled water by syringe one time in the newborn's mouth 2 minutes before heel stick
16021443|NCT02728115|Biological|Cellavita HD Lower Dose|The first three participants enrolled in the study will be assigned to the lower dose arm with staggered treatment, with an interval of 30 days between the first administration of the first participant and the first administration of the second participant assigned to this arm. All participants will receive a total of 3 intravenous administration, one every 30 days.
16021444|NCT02728115|Biological|Cellavita HD Higher dose|The last three participants enrolled in the study will be assigned to the higher dose arm with staggered treatment, with an interval of 30 days between the first administration of the first participant and the first administration of the second participant assigned to this arm. All participants will receive a total of 3 intravenous administration, one every 30 days.
16021475|NCT02727946|Other|optimal resuscitation|optimal resuscitation to achieve mean arterial blood pressure above 65 mmHG , Central venous pressure more than 8 mmHg , urine out put more than 0.5 ml /Kg/hour
16021452|NCT02728089|Drug|MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g)|MK-7625A 1.5 g (ceftolozane 1 g/tazobactam 0.5 g) administered as an intravenous (IV) infusion
16021453|NCT02728076|Radiation|Phase II - Preoperative Radiation followed by Lumpectomy.|Selected patients will undergo a radiation planning procedure utilizing magnetic resonance imaging (MRI). Once this is completed, patients will receive five radiation treatments given every other day. After 28 days (four weeks), patients will have another MRI scan to compare tumor response to the radiation therapy. Following the MRI scan, roughly five to eight weeks later, patients will have a lumpectomy and possibly a sentinel lymph node biopsy. After surgery, tests will be performed on the tumor tissue to determine if genes expressed in the sample have changed. Following surgery, patients will receive chemotherapy and/or antihormone therapy at the discretion of the patient and physician.
16021454|NCT02728063|Dietary Supplement|Lactibiane Tolerance|probiotics
16021455|NCT02728050|Drug|Cladribine|Given IV
16021456|NCT02728050|Drug|Cytarabine|Given IV
16021457|NCT02728050|Biological|Filgrastim|Given SC
16021458|NCT02728050|Other|Laboratory Biomarker Analysis|Correlative studies
16021459|NCT02728050|Other|Quality-of-Life Assessment|Ancillary studies
16021460|NCT02728050|Drug|Mitoxantrone|Given IV
16021461|NCT02728050|Drug|Sorafenib|Given PO
16021462|NCT02728037|Procedure|Magnesium-Based Injection Formulation|"Each study kit will include 4 10cc syringes containing 7ml of 1% lidocaine, and 3 numbered glass vials. For those in the magnesium-based injection formulation arm the glass vials will be prepared as follows; 1) 10ml of 50% magnesium sulfate, 2) 20ml of 8.4% bicarbonate, and 3) 20ml of 50% dextrose.
~At the visit a study investigator will mix 2cc of vial 1, 5cc of vial 2 and 5cc of vial 3, for a total of 12cc of additive mixture. 3cc of this additive mixture will be then drawn in to each of the 4 pre-packaged lidocaine syringes, for a total of 10cc of final mixture per syringe. The concentration of components in the final mixture is 0.7% lidocaine, 0.8% sodium bicarbonate, 6.0% dextrose, and 2.5% magnesium sulfate."
16021463|NCT02728037|Procedure|Lidocaine-Only Injection Formulation|"Each study kit will include 4 10cc syringes containing 7ml of 1% lidocaine, and 3 numbered glass vials. For those in the lidocaine-based injection formulation arm the glass vials will be prepared as follows; 1) 10ml of 0.9% sodium chloride, 2) 20ml of 0.9% sodium chloride, and 3) 20ml of 0.9% sodium chloride.
~At the visit a study investigator will mix 2cc of vial 1, 5cc of vial 2 and 5cc of vial 3, for a total of 12cc of additive mixture. 3cc of this additive mixture will be then drawn in to each of the 4 pre-packaged lidocaine syringes, for a total of 10cc of final mixture per syringe. The concentration of components in the final mixture is 0.7% lidocaine."
16021464|NCT02728037|Drug|lidocaine|
16021465|NCT02728037|Drug|magnesium sulfate, bicarbonate, dextrose.|
16021466|NCT02728024|Other|Missing items, Errors in Completion, Difficulties|
16021467|NCT02728011|Other|Scientific Brain Training (SBT)|Cognitive training
16021468|NCT02728011|Other|Tetris|
16021469|NCT02727998|Drug|Ketamine|Prolonged exposure therapy combined with a single infusion of 0.50 mg/kg/hour for 40 min on day 2.
16021470|NCT02727998|Drug|Midazolam|Prolonged exposure therapy combined with a single infusion of 0.045 mg/kg/hour for 40 min on day 2.
16021471|NCT02727985|Procedure|Pharmacist weaning schedule|individualized weaning schedule for each patient taking into account the amount of opioid, duration of opioid use, other adjunctive medications, and specific variables related to the patient.
16021472|NCT02727972|Behavioral|Cognitive Testing|Verbal assessments as well as computer testing.
16021473|NCT02727972|Other|MRI|Anatomical MRIs will be performed on a Siemens 3T Trio at Yale. MR acquisition will be a Sag 3D magnetization-prepared rapid gradient-echo (MPRAGE) sequence with 3.34 ms echo time, 2,500 ms repetition time, 1,000 ms inversion time, 7 degree flip angle, and 180 Hz/pixel bandwidth. The image dimensions will be 256 x 256 x 176 and pixel size 0.98 x 0.98 x 1.0 mm. Resting state MRIs will also be obtained as follows: We will be doing 2 six minute scans with subjects in the scanner, eyes open, fixating a cross. TR = 3 secs 45 slices x 3 mm slice thickness = 13.5 cm. In plane resolution = 3 x 3 mm, slice acquisition order = ascending.
16021474|NCT02727972|Radiation|PET|High Resolution Research Tomograph (HRRT), the highest resolution human brain scanner available, or HR+ will be used to image subjects. Vital signs (blood pressure, pulse, respiration) will be obtained before and after radiotracer administration. An antecubital venous catheter will be used for IV administration of the radiotracer and for venous blood sampling. A radial artery catheter will be inserted by an experienced physician before the PET scan. At the beginning of each scan, the subject's head will be immobilized and a 6 minute transmission scan using an orbiting 137Cs (HRRT) or 68GE (HR+) point-source is obtained and used for attenuation correction. PET scans will be acquired using bolus or bolus plus constant infusion administration of FPEB, ABP688, or SV2A.
16097156|NCT02183753|Other|wood smoke|
16021476|NCT02727920|Dietary Supplement|Energy drink|
16021477|NCT02727920|Other|Placebo|placebo drink
16021478|NCT02727907|Drug|BCD-033 (interferon beta 1a)|Subcutaneous injection of BCD-033, 44 µg (0,5 ml) 3 times per week, every other day, for 92 weeks
16021479|NCT02727907|Drug|Rebif (interferon beta 1a)|Subcutaneous injection of Rebif, 44 µg (0,5 ml) 3 times per week, every other day, for 48 weeks
16021480|NCT02727907|Drug|Placebo|Subcutaneous injection of placebo, 0,5 ml 3 times per week, every other day, for12 weeks
16021481|NCT02727881|Drug|Squalamine lactate ophthalmic solution, 0.2%|Squalamine lactate ophthalmic solution, 0.2%
16021482|NCT02727881|Drug|Placebo Ophthalmic solution|Placebo Ophthalmic solution
16021483|NCT02727881|Drug|ranibizumab|ranibizumab
16021484|NCT02727868|Genetic|blood samples|
16021485|NCT02727855|Biological|Shanchol|Oral Cholera Vaccine
16021486|NCT02727842|Device|CP950 Sound Processor|An off-the-ear processor configuration with identical functionality to the commercially approved CP910/920 processor
16021487|NCT02727842|Device|Wireless programming pod|The CP950 Sound Processor will be programmed by the wireless programming pod, which is needed as the interface to commercially approved programming software
16021488|NCT02727829|Device|pefusion index measurement|perfusion index measurement using massimo radical 7 device
16021489|NCT02727816|Device|filcon IV I (BC 8.6)|control lens
16021490|NCT02727816|Device|filcon IV I (BC 8.7)|control lens
16021491|NCT02727816|Device|ocufilcon D|test lens
16021492|NCT02727816|Device|methafilcon A (BC 8.6)|control lens
16021493|NCT02727816|Device|methafilcon A (BC 8.7)|control lens
16021494|NCT02727816|Device|somofilcon A|test lens
16021495|NCT02727803|Biological|Allogeneic Natural Killer Cell Line NK-92|Given IV
16021496|NCT02727803|Biological|Anti-Thymocyte Globulin|Given IV
16021497|NCT02727803|Drug|Busulfan|Given IV
16021498|NCT02727803|Drug|Clofarabine|Given IV
16021499|NCT02727803|Drug|Cyclophosphamide|Given IV
16021500|NCT02727803|Drug|Fludarabine Phosphate|Given IV
16021501|NCT02727803|Other|Laboratory Biomarker Analysis|Correlative studies
16021502|NCT02727803|Drug|Melphalan|Given IV
16021503|NCT02727803|Biological|Rituximab|Given IV
16021504|NCT02727803|Radiation|Total-Body Irradiation|Undergo total body irradiation
16021505|NCT02727803|Procedure|Umbilical Cord Blood Transplantation|Undergo umbilical cord blood transplantation
16021506|NCT02727790|Device|Stimulator|
16021507|NCT02727777|Drug|TAK228|Starting dose of TAK228: 3 mg by mouth every day of a 28 day cycle.
16021508|NCT02727777|Other|Blood Sugar Testing|Participant given a glucometer to check pre-dose blood sugar levels at home every day.
16021509|NCT02727764|Genetic|ART-I02|Single Intra-articular injection in the carpometacarpal (CMC), metacarpophalangeal (MCP), proximal interphalangeal (PIP), or distal interphalangeal (DIP) joint
16021510|NCT02727751|Drug|Tenapanor|
16021511|NCT02727738|Dietary Supplement|Selenium|Selenium 80 mg bid for 90 days
16021512|NCT02727738|Drug|Methimazole|Methimazole starting dose depending on FT3 values (15 mg/day or 20 mg/day or 30 mg/day, for FT3 values <10 pg/ml, 10-15 pg/ml, >15 pg/ml, respectively) to be tapered by 5 mg/day every 15 days down to values sufficient for FT3 to be normal
16021513|NCT02727725|Other|Traminer MRI Sequence|The Traminer MRI sequence will be added to the standard IR Turbo-Flash sequence and last 2-5 minutes.
16021514|NCT02727712|Procedure|bilateral thoracic paravertebral block|group A under TPVB((TPVB T2/3+T5/6) by ropivacaine(0.3%,10ml*4)program
16021515|NCT02727712|Device|Transesophageal Echocardiography（TEE）|"Apply Transesophageal Echocardiography（TEE）after anesthesia induction and draw 400ml autologous blood (Haemonetics®)used for the postoperative transfusion;
~Goal-directed fluid management"
16021516|NCT02727712|Device|Lung protection measure during the surgery（Dräger Primus）|Protective ventilation strategy(Low tidal volume about 6~7ml/kg, joint use of PEEP)
16021517|NCT02727712|Drug|Anesthesia drugs during the surgery|"Bilateral thoracic paravertebral block before induction of anesthesia;
~Fast channel anesthesia • Induction use Sufentanil 0.5~1ug/kg, Vecuronium for Injection 0.15mg/kg and Etomidate 0.2~0.6mg/kg; ②. Maintain use Sufentanil Hydrochloride for Injection 0.01~0.04ug/kg•min, Sevoflurane 0.5~1.5MAC（minimum alveolar concentration） and Infusing Dexmedetomidine which load dose 0.5μg/kg in 10min then changed into 0.5-1.0μg/kg•h,Vecuronium 0.06~0.12mg/kg•h; ③. Intravenous hydromorphone Hydrochloride Injection 0.15mg/kg before surgery over."
16021518|NCT02727712|Procedure|thoracic paravertebral block|group B under(TPVB T3/4)by ropivacaine(0.3%,20ml*2)program
16021519|NCT02727699|Drug|Xanamem™|Xanamem™ is formulated in green and cream coloured size 3, Coni-Snap shaped gelatin capsules as an excipient blend at a dose of 10mg. It contains active pharmaceutical ingredient of UE2343
16021520|NCT02727699|Drug|Placebo (for Xanamem™)|Excipient blend capsules manufactured to mimic Xanamem™ capsules
16021521|NCT02727686|Other|Water Load (WL) Post-Operative Day 1|Patient will have normonatremic 0600 hr sodium level (Serum Sodium = 135 - 145 mmol/L), ability to safely take water by mouth, and cleared to continue by treating surgeon. WL will be calculated (20 mL/kg body weight) and supplied at the bedside. Vasopressin level will be determined. Patient will have 30 minutes to consume WL, or will be excluded. Included patients will have data collected as follows: 1 hour - serum sodium, urine output; 2 hour - serum sodium, urine output, vasopressin level; 6 hours - serum sodium, urine output.
16021522|NCT02727660|Drug|BFF MDI (PT009) 320/9.6 μg|Blinded Treatment
16021523|NCT02727660|Drug|BFF MDI (PT009) 160/9.6 μg|Blinded Treatment
16021524|NCT02727660|Drug|FF MDI (PT005) 9.6 μg|Blinded Treatment
16021525|NCT02727647|Drug|FVIII|FVIII concentration 35-40 U/kg/dose 1 time/week for 5 months
16021526|NCT02727647|Drug|FVIII|FVIII concentration 15-20 U/kg/dose 1 time/week for 5 months
16021566|NCT02727374|Other|Physiotherapy intervention|Physiotherapy intervention consists of conventional exercise program administered to this kind of patients at Hospital Clinico, including strengthening and balance exercises
16021567|NCT02727374|Behavioral|Cognitive-behavioural Intervention|Psychological treatment consists of group talks to treat the fear to fall
16021568|NCT02727361|Radiation|PET (Positron Emission Tomography) imaging|Molecular imaging using a PET radiotracer of the vesicular acetylcholine transporter.
16021527|NCT02727634|Other|Comparison cardiac power and cardiac power output at different time points in the perioperative period|The intervention is a comparison between two methods of calculating the heart's energy delivery, cardiac power, measured in watts. A tertiary measurement is calculation of arterioventricular coupling. All patients will have cardiac power output calculated through the use of Doppler echocardiography. The echocardiography based cardiac output will be done through the velocity time integral of the left ventricular outflow tract (LVOT). This will be compared against total power as measured by our Ultrapower approach which involves instantaneous doppler measurement of cardiac output through LVOT multiplied with simultaneous radial artery pressure. This and ejection fraction (for calculation of ventriculoarterial coupling) will be recorded at rest in neutral position preoperatively, directly post operatively and the day after operation. Directly postoperatively the power measurements will also be repeated in Trendelenburg and anti Trendelenburg position.
16021528|NCT02727621|Drug|Dexmedetomidine|Anesthesia will be maintained with continuous infusion of dexmedetomidine 0.5-0.7 µg/kg/h in addition to sevoflurane supplementation as required, to maintain arterial blood pressure and heart rate within 20% of preoperative values. Muscle relaxation will be maintained with continuous rocuronium infusion 0.6 mg/kg/h.
16021529|NCT02727621|Drug|propofol|Anesthesia will be maintained with continuous infusion of propofol 50-100 µg/kg/min in addition to sevoflurane supplementation as required, to maintain arterial blood pressure and heart rate within 20% of preoperative values. Muscle relaxation will be maintained with continuous rocuronium infusion 0.6 mg/kg/h.
16021530|NCT02727608|Drug|Eculizumab|Intravenous infusion (1200 mg) over 35 minutes. Consecutive infusions (900 mg) on Days 1, 7 and 14.
16021531|NCT02727595|Device|CyclaPlex Implant|Button and suture type implant that will be implanted between the first and second metatarsal
16021532|NCT02727569|Device|New visual field algorithm with DLS|Mathematical model (software based) to derive retinal sensitivity.
16021533|NCT02727569|Device|SITA algorithm|Mathematical model (software based) to derive retinal sensitivity. Commercially available.
16021534|NCT02727569|Device|New visual field algorithm with MMDT|Mathematical model (software based) to derive retinal sensitivity.
16021535|NCT02727556|Behavioral|visual images|
16021536|NCT02727543|Other|Medisafe|"Medisafe is a smartphone application available to download for free on any iOS or Android device. Medisafe addresses non-adherence by providing alerts to patients when it is time to take their medications. Other features include the ability to allow a Medfriend to check in if a medication is not taken, weekly reports of medication adherence, and monitoring of biometric measurements"
16021537|NCT02727530|Other|VISCERAL MANUAL THERAPY-ADVICES|The subjects of this group will receive an amount of two sessions of visceral manual therapy that will be applied within two weeks. In the first session will be applied procedures in the most superficial body structures. And, in the second session will be applied procedures in the most deep body structures.
16021538|NCT02727530|Other|ADVICES|Advices for parents to improve the management of infant colic
16021539|NCT02727517|Procedure|Early (≤ 60 seconds) cord clamping|If the infant don't breathe, the umbilical cord is clamped (≤ 60 seconds) and cut and resuscitation will be provided at a resuscitation table
16021540|NCT02727517|Procedure|Delayed (≥ 180 seconds) cord clamping|If the infant don't breathe, the umbilical cord is not clamped and cut until after 180 seconds. Initial resuscitation will be provided bedside to the mother
16021541|NCT02727504|Device|Electrocardiogram|ECG at inclusion and M12
16021542|NCT02727504|Device|2D and 3D echocardiography|2D and 3D echocardiography at inclusion and M12
16021543|NCT02727504|Device|Dobutamine stress echocardiography|dobutamine stress echocardiography at inclusion
16021544|NCT02727504|Biological|Blood tests|Blood test electrolytes, creatinine, hemoglobin, NT-proBNP, CRP, ST-2 at inclusion and M12
16021545|NCT02727504|Device|Cardiac MRI|Cardiac MRI at inclusion
16021546|NCT02727504|Device|Cardiac scanner|Cardiac scanner at inclusion
16021547|NCT02727504|Other|6-minutes walking test|6-minutes walking test at inclusion and M12
16021548|NCT02727504|Other|Duke Activity Score|Duke Activity Score at inclusion and M12
16021549|NCT02727491|Drug|Dextromethorphan|Dextromethorphan is a drug of the morphinan class with sedative, dissociative, and stimulant properties (at higher doses). Dextromethorphan has been explored for a number other uses in medicine, including pain relief (as either the primary analgesic, or an opioid potentiator).
16021550|NCT02727491|Drug|Placebo|Placebo syrup identical to active comparator in taste, appearance and volume but is inactive. Placebo comparator will be used in the placebo arm of the trial.
16021551|NCT02727478|Other|HiBalance training program|The program consists of physiotherapist led highly challenging balance exercises, which are adapted and progressed on both a group and individual basis throughout the training period.
16021552|NCT02727465|Other|Meningitis cases|None - blood draw only
16021553|NCT02727452|Other|Skin-to-skin contact|
16021554|NCT02727439|Other|Acute Exhausting Exercise (AE)|A single progressive rowing training to maximal exhaustion (AE).
16021555|NCT02727426|Other|Low Salt (LS) diet|Intake of less than 2.3 g of salt per day for 7 days.
16021556|NCT02727426|Other|High Salt (HS) diet|Intake of 11.2 g of salt per day for 7 days.
16021557|NCT02727413|Procedure|Blood sample collection|Drawing of 10 ml blood at inclusion, at the time of CPB connection, 60 min under CPB, at the time of CPB disconnection, 6, 24 and 48 hours post-surgery
16021558|NCT02727413|Other|Assessment of signs of organ dysfunction|Assessment of signs of organ dysfunction based on medical data prior to surgery, 24 and 48 hours post-surgery, and at the time of ICU discharge
16021559|NCT02727387|Drug|TEMIRI|Window therapy frontline for VHR patients
16021560|NCT02727387|Drug|ADM|Drug used in the Induction phase in association with Vincristine, Ifosfamide, cyclophosphamide and Etoposide
16021561|NCT02727387|Drug|IFO|Drug used in the Induction phase in association with Vincristine, Adriamycin, cyclophosphamide and Etoposide
16021562|NCT02727387|Drug|CYC|Drug used in the Induction phase in association with Vincristine, Ifosfamide, Adriamycin and Etoposide
16021563|NCT02727387|Drug|ETO|Drug used in the Induction phase in association with Vincristine, Ifosfamide, cyclophosphamide and Adriamycin
16021564|NCT02727387|Drug|BUMEL|Consolidation phase
16021565|NCT02727387|Drug|VIN|Drug used in the Induction phase in association with cyclophosphamide , Ifosfamide, Adriamycin and Etoposide
16097157|NCT02183753|Other|clean air|
16021569|NCT02727361|Other|MRI : Magnetic Resonance Imaging|Multimodal MRI, MRI diffusion tensor (to study the microscopic structure of white matter) and functional MRI of the resting state (to study the functional organization of cerebral cholinergic networks at rest).
16021570|NCT02727348|Procedure|Sciatic with or without femoral block|Sciatic with or without femoral block performed either with ultrasound and/or nerve stimulator on the patient with 3mg/kg of ropivacaine
16021571|NCT02727348|Procedure|Spinal anaesthesia|Spinal anaesthesia with up to 3mls of 0.5% bupivacaine
16021572|NCT02727322|Drug|Nitrofurantoin|Patients will receive nitrofurantoin 100mg once daily or a placebo. Pills will be identical.
16021573|NCT02727322|Drug|Placebo|Placebo
16021574|NCT02727309|Drug|Apatinib|Apatinib: 750 mg is administered orally daily, until disease progression or untolerable toxicity.
16021575|NCT02727296|Drug|sevoflurane|General anesthesia with sevoflurane
16021576|NCT02727296|Drug|propofol|General anesthesia with propofol
16021577|NCT02727283|Drug|GSK3179106|GSK3179106 will be provided as white to slightly colored round or oblong tablet for oral administration with unit dose strength of 5 mg, 25 mg and 100 mg
16021578|NCT02727283|Drug|Placebo|Placebo will be provided as white to slightly colored round or oblong tablet for oral administration with unit dose strength to match actives across all strengths
16021579|NCT02727270|Other|No Intervention - Observational Study|No Intervention - Observational Study
16021580|NCT02727257|Procedure|MIRT|MIRT consists of a 4-week physical therapy that entails four daily sessions, five days a week, in a hospital setting. The duration of each session, including recovery periods, is about one hour. The first session comprise cardiovascular warm-up activities, relaxation, muscle-stretching, exercises to improve the range of motion of spinal, pelvic and scapular joints, exercises to improve the functionality of the abdominal muscles, and postural changes in the supine position. The second session includes aerobic exercises to improve balance and gait using a stabilometric platform, treadmill plus, crossover and cycloergometer. The third is a session of occupational therapy to improve autonomy in day living activities. The last session includes one hour of speech therapy.
16021581|NCT02727244|Procedure|urgent or elective cesarean section|a kind of surgical procedure to deliver a baby
16021582|NCT02727231|Device|Florence D2A or similar closed loop glucose control system|Subject's glucose level will be controlled by the Florence D2A or similar automated closed loop glucose control system. The system comprises of FreeStyle Navigator 2 ® Continuous Glucose Monitoring (CGM) System (Abbott Diabetes Care, Alameda, CA, USA), Dana R Diabecare subcutaneous insulin infusion pump (Sooil Corp. Seoul, South Korea)or similar insulin pump, and MPC-based glucose control algorithm running on a smartphone
16021583|NCT02727231|Device|CSII with CGM|Subject glucose level controlled by usual insulin pump therapy in conjunction with continuous glucose monitoring (CGM)
16021584|NCT02727218|Procedure|Chest tube removal|chest tube removal post thoracoscopic surgery
16021585|NCT02727205|Drug|Rotigotine Transdermal System|
16021586|NCT02727192|Device|PAP (CPAP or ASV)|Patients will be randomized to treatment of Sleep Apnea with a CPAP or control
16021587|NCT02727179|Procedure|Liver resection|The investigators perform an anatomical liver resections or wedge resections depending on tumour's location and tumour's characteristics
16021588|NCT02727166|Dietary Supplement|Inulin|Administered in 4 g sacchets taken in 200 mL liquid during breakfast and dinner for 4 week intervention period
16021589|NCT02727166|Dietary Supplement|Maltodextrine|Administered in 4 g sacchets taken in 200 mL liquid during breakfast and dinner for 4 week intervention period
16021590|NCT02727153|Other|"Ultra E.R.A.S."|
16021591|NCT02727153|Other|Classic E.R.A.S.|
16021592|NCT02727140|Behavioral|Yoga with Asana (yoga postures)|Yoga intervention consisting of asana, breathing and relaxation, meditation
16021593|NCT02727140|Behavioral|Yoga without Asana (yoga postures)|Yoga intervention without asanas, consisting only of breathing, relaxation and meditation
16021594|NCT02727114|Other|Echographic measurement of skin thickness|"(Epi)Dermal thickness at the proximal forearm, the deltoid region and medial site of the thigh (till 2 years) will be measured using imaging technology, more specifically high-frequency ultrasound (20-70 MHz) in B-mode (VEVO 2100® & VEVO 3100®, Visual Sonics). This non-invasive measuring technique has already been proven to be accurate.
~The echographic measurement will be performed on the left and right deltoid and medial thigh region, and on two sides of the proximal forearm. Both the dorsal part and the volar/palmar part of the proximal forearm will be investigated. Ultrasound will be executed using gel (Aquasonic®) to optimize imaging."
16021595|NCT02727101|Drug|perampanel|Each group of 6 patients will be followed for 12 weeks of baseline observation on baseline medication. Seizure frequency will be counted, using subjects' self-reported seizure diaries. Perampanel will be titrated to 8-12 mg/day, with the final dose determined by side effects and tolerability of Perampanel at 8-12 mg/day doses. Titration will occur at the rate of 2 mg/week or two weeks, as tolerated.
16021596|NCT02727088|Procedure|Pulpotomy|Conservative pulp management (experimental treatment): ablation of the coronal part of the pulp
16021597|NCT02727088|Procedure|Pulpectomy|ablation of the whole dental pulp, preparation and filling of the whole root canal system
16021598|NCT02727062|Device|OM Pain App|"Each study participant will be issued an Android smartphone, or he or she may use his/her own compatible device (whether or not it has an active data service) to which the OM Pain App will be downloaded and installed. Subjects will receive a preprogrammed alarm four times a day from their smartphones prompting them to directly enter OM pain levels on the device. Patients may submit as many pain entries as they wish beyond the four minimum levels.
~Subjects will receive a preprogrammed alarm four times a day from their smartphones prompting them to directly enter OM pain levels on the device. Patients may submit as many pain entries as they wish beyond the four minimum levels."
16021599|NCT02727062|Device|Accelerometer|Each patient will be issued an accelerometer and will be encouraged to wear it continuously during the study period (weekly during radiation therapy and four weeks following radiation therapy).
16021600|NCT02727049|Other|Osteopathic manipulative medicine (OMM)|Osteopathic manipulative medicine includes all types of manual therapies to gently restore and/or optimize one's natural joint, muscle, and other soft tissue balance.
16021601|NCT02727036|Dietary Supplement|Pumpkin seed oil|1 gram capsule of Pumpkin seed oil.
16021602|NCT02727036|Dietary Supplement|Pumpkin seeds|4.1 grams (1½ teaspoons/~0.15ounces) of pumpkin seeds
16022315|NCT02722447|Drug|rivaroxaban|Rivaroxaban 20 mg for 6 weeks
16021603|NCT02727023|Other|Osteopathic Manipulative Medicine|The procedures are picked for their generalized effect on the lymphatic system based on osteopathic literature and research. Our goal is to mobilize the lymphatic fluid to induce an increase of endocannabinoids. These procedures are similar to mechanical motion seen in exercise in regards to lymphatic movement. Each technique will be performed for a total of four minutes each
16021604|NCT02726997|Drug|Carboplatin|Given IV
16021605|NCT02726997|Biological|Durvalumab|Given IV
16021606|NCT02726997|Other|Laboratory Biomarker Analysis|Correlative studies
16021607|NCT02726997|Drug|Paclitaxel|Given IV
16021608|NCT02726997|Other|Pharmacological Study|Correlative studies
16021609|NCT02726997|Other|Quality-of-Life Assessment|Ancillary studies
16021610|NCT02726984|Drug|18F-sodium fluoride PET/MR|18F-sodium fluoride PET/MR combining 3Tesla (3T) MR and PET producing 127 slices of 2 mm on an axial field of view of 26 cm. 18F-sodium fluoride (2 à 4 megabecquerel/kilogram (MBq/kg)) will be injected 60 min before.
16021611|NCT02726971|Drug|Femoston|Femoston is a Complex Packing Estradiol Tablets and Estradiol and Dydrogesterone.
16021612|NCT02726945|Device|GID SVF-2|The GID SVF-2 device is a sterile single-use disposable canister used for harvesting, filtering, separating, and concentrating autologous stromal vascular fraction cells from adipose tissue for reintroduction to the same patient during a single surgical procedure for treatment of pain associated with joint osteoarthritis.
16021613|NCT02726945|Other|Placebo|Placebo Control
16021614|NCT02726932|Other|No intervention, merely observational|
16021615|NCT02726919|Drug|Clobazam|Following a baseline of 12 weeks patients will be started on clobazam, administered orally in b.i.d. schedule. In patients in whom seizure diaries have been kept prospectively prior to study screening visit, retrospective baseline will be accepted. Patients will be titrated up to either seizure freedom, to side effects or to 40 mg/day, whichever comes first
16021616|NCT02726906|Behavioral|Moderate-aerobic walking|
16021617|NCT02726906|Radiation|Positron Emission Tomography (PET) scan|Radioligand that binds to proteins using a PET/CT scanner.
16021618|NCT02726906|Behavioral|Healthy living education|
16021619|NCT02726906|Device|Physical activity monitor|Wrist device that will track daily physical activity
16021620|NCT02726893|Other|no intervention|
16021621|NCT02726880|Behavioral|Behavioral therapy|6-week behavioral intervention designed to assist with better monitoring and regulating the child's game playing behaviors.
16021622|NCT02726880|Behavioral|Referral for care|Referral for mental health issues and family support services
16021623|NCT02726867|Drug|levetiracetam|Treatment will consist of LEV 4000 mg i.v. over 10 minutes.
16021624|NCT02726867|Drug|lacosamide|Treatment will consist of LCM 600 mg i.v. over 10 minutes
16021625|NCT02726867|Drug|Ketamine|Treatment will consist of KET 2.5 mg/kg over 10 minutes
16021626|NCT02726867|Drug|Phenobarbital|Treatment will consist of PHB 15 mg/kg mg i.v. at 100 mg/minute rate
16021627|NCT02726854|Drug|Apatinib|Patients with pancreatic cancer who are failed of receiving first-line chemotherapy and cannot tolerate second-line chemotherapy or unwilling to receive second-line chemotherapy will receive Apatinib Tablets (850mg once daily, orally) 30 minutes after meal with warm water. Take 28 days as a cycle, patients will receive this treatment until they have got disease progressed.
16021628|NCT02726841|Procedure|Open thoracoabdominal aortic repair + abdominal stenting|Thoracoabdominal aortic dissection (TAAD) repair + bare aortic stent (Djumbodis) implantation
16021629|NCT02726841|Procedure|Classic thoracoabdominal aortic repair|Thoracoabdominal aortic dissection (TAAD) repair
16021630|NCT02726828|Drug|intrathecal morphine|patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.3 mg intrathecal morphine1 ml volume.
16021631|NCT02726828|Drug|intrathecal ketamine|patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and 0.1 mg/kg intrathecal ketamine in 1ml volume.
16021632|NCT02726828|Drug|intrathecal morphine + ketamine|patients received 10 mg of hyperbaric bupivacaine 0.5% in 2 ml volume and intrathecal morphine + ketamine 0.3 mg and 0.1 mg/kg respectively in 1 ml volume.
16021633|NCT02726815|Other|Questionnaire|Questionnaire based study using a symptom assessment tool
16021634|NCT02726802|Other|physical therapy vs. primary care interventions|Subjects with acute (< 3 months onset) will be randomized to see either a physical therapist or a primary care provider as their initial entry into the healthcare system
16021635|NCT02726789|Drug|REP 2139-Ca|the nucleic acid polymer REP 2139 formulated as a calcium chelate complex
16021636|NCT02726789|Drug|pegylated interferon|immunotherapy
16021637|NCT02726789|Drug|entecavir|local generic entecavir
16021638|NCT02726776|Other|Suspension in a harness|
16021639|NCT02726776|Other|Climbing|
16021640|NCT02726763|Device|Transcranial Direct Current Stimulation (tDCS)|
16021641|NCT02726763|Behavioral|Questionnaires|
16021642|NCT02726750|Procedure|Biospecimen Collection|Undergo collection of blood samples
16021643|NCT02726750|Other|Laboratory Biomarker Analysis|Correlative studies
16021644|NCT02726737|Drug|sodium bicarbonate|
16021645|NCT02726737|Drug|Lidocaine|
16021646|NCT02726737|Drug|sterile distilled water|
16021647|NCT02726724|Other|5 observers|
16021648|NCT02726724|Other|1 observer|
16021649|NCT02726711|Drug|Trimethaphan|Trimethaphan will be infused (0.5 - 4.0 mg IV)
16021650|NCT02726711|Drug|Placebo|0.5 - 4.0 mg IV to be infused
16021651|NCT02726685|Other|respiratory training.|breathing exercise.
16021652|NCT02726685|Other|sham training.|range of motion (ROM) exercise, stretching exercise or positioning exercise.
16021653|NCT02726672|Device|respiratory rehabilitation using Powerbreathe|10 minutes 2 times a day : 30 inspirations per session during 10 weeks
16021654|NCT02726659|Drug|Celecoxib|Adjunct celecoxib
16021655|NCT02726659|Drug|Placebo|Adjunct placebo
16021656|NCT02726646|Drug|Doxycycline|Application of 1 mg of doxyxycline microspheres at 4 sites (two means and two deep periodontal pockets) after mechanical debridement.
16021657|NCT02726646|Procedure|Mechanical debridement|Mechanical debridement (full mouth) of 45 minutes associated with the application of 1 mg of microspheres placebo in selected periodontal pockets.
16021658|NCT02726646|Drug|Placebo|The application of 1 mg of microspheres placebo
16021659|NCT02726620|Procedure|Attending real-time decision support|Near real-time decision support elements will notify the attending anesthesiologists of a blood pressure drop below the threshold for intraoperative hypotension (mean arterial pressure below 60 mmHg). The notification is presented through the pager system. The page will also display the associated increased risk of organ injury due to organ ischemia.
16021660|NCT02726620|Procedure|In-room real-time decision support|Near real-time decision support elements will notify the in-room anesthesia provider of a blood pressure drop below the threshold for intraoperative hypotension (mean arterial pressure below 60 mmHg). The notification is presented through the anesthesia information management system. The decision support system will display the associated increased risk of organ injury due to organ ischemia.
16021661|NCT02726620|Procedure|Attending feedback emails|Attending anesthesiologists will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension (mean arterial pressure below 60 mmHg or lower for a particular duration) that is associated with an increased risk of organ injury due to organ ischemia.
16021662|NCT02726620|Procedure|In-room provider feedback emails|In-room anesthesia providers will be notified through email within 24 hours after the end of an anesthetic case, when the patient had an episode of intraoperative hypotension (mean arterial pressure below 60 mmHg or lower for a particular duration) that is associated with an increased risk of organ injury due to organ ischemia.
16021663|NCT02726620|Device|Anesthesia Information Management System (AIMS)|The anesthesia electronic record keeping system
16021664|NCT02726620|Device|Perioperative Data Warehouse (PDW)|The data warehouse that is used to gather perioperative data and create user reports. In this instance the PDW will be used to send the postoperative feedback emails.
16021665|NCT02726620|Procedure|General anesthesia|Any anesthetic drugs that are used to induce general anesthesia above the level of sedation.
16021666|NCT02726620|Device|Pager system|The mobile pager system through which alerts can be sent
16021667|NCT02726620|Procedure|Central neuraxial anesthesia|Regional anesthesia effectuated through the placement of local anesthetics around the nerves of the central nervous system, e.g. spinal anesthesia and epidural anesthesia.
16021668|NCT02726620|Procedure|Non-cardiac surgery|Any surgical intervention that is not aimed at surgical correction of the heart
16021669|NCT02726620|Drug|Propofol|Anesthetic drug used to maintain general anesthesia
16021670|NCT02726620|Drug|Sevoflurane|Anesthetic drug used to maintain general anesthesia
16021671|NCT02726620|Drug|Desflurane|Anesthetic drug used to maintain general anesthesia
16021672|NCT02726620|Drug|Isoflurane|Anesthetic drug used to maintain general anesthesia
16021673|NCT02726620|Drug|Ephedrine|Cardiovascular drug used to treat intraoperative hypotension
16021674|NCT02726620|Drug|Phenylephrine|Cardiovascular drug used to treat intraoperative hypotension
16021675|NCT02726620|Drug|Norepinephrine|Cardiovascular drug used to treat intraoperative hypotension
16021676|NCT02726620|Drug|Epinephrine|Cardiovascular drug used to treat intraoperative hypotension
16021677|NCT02726620|Drug|Dobutamine|Cardiovascular drug used to treat intraoperative hypotension
16021678|NCT02726620|Drug|Dopamine|Cardiovascular drug used to treat intraoperative hypotension
16021679|NCT02726620|Drug|Isoproterenol|Cardiovascular drug used to treat intraoperative hypotension
16021680|NCT02726620|Drug|Milrinone|Cardiovascular drug used to treat intraoperative hypotension
16021681|NCT02726620|Drug|Atropine|Cardiovascular drugs used to treat intraoperative hypotension
16021682|NCT02726620|Drug|Glycopyrrolate|Cardiovascular drug used to treat intraoperative hypotension
16021683|NCT02726620|Drug|Vasopressin|Cardiovascular drug used to treat intraoperative hypotension
16021684|NCT02726620|Drug|Terlipressin|Cardiovascular drug used to treat intraoperative hypotension
16021685|NCT02726620|Drug|Sodium Chloride 0.9%|Intravenous fluid used to treat intraoperative hypotension
16021686|NCT02726620|Drug|Ringer's lactate|Intravenous fluid used to treat intraoperative hypotension
16021687|NCT02726620|Drug|Hydroxyethyl starch solutions|Intravenous fluid used to treat intraoperative hypotension
16021688|NCT02726620|Drug|Fresh Frozen Plasma|Intravenous fluid used to treat intraoperative hypotension
16021689|NCT02726620|Drug|Packed Red Blood Cells|Intravenous fluid used to treat intraoperative hypotension
16021690|NCT02726620|Drug|Albumin solutions|Intravenous fluid used to treat intraoperative hypotension
16021691|NCT02726620|Drug|Plasma-Lyte|Intravenous fluid used to treat intraoperative hypotension
16021692|NCT02726620|Drug|Lidocaine|Local anesthetic used for central neuraxial anesthesia.
16021693|NCT02726620|Drug|Bupivacaine|Local anesthetic used for central neuraxial anesthesia.
16021694|NCT02726620|Drug|Levobupivacaine|Local anesthetic used for central neuraxial anesthesia.
16021695|NCT02726620|Drug|Ropivacaine|Local anesthetic used for central neuraxial anesthesia.
16021696|NCT02726620|Drug|Mepivacaine|Local anesthetic used for central neuraxial anesthesia.
16021697|NCT02726620|Drug|Tetracaine|Local anesthetic used for central neuraxial anesthesia.
16021698|NCT02726620|Drug|Prilocaine|Local anesthetic used for central neuraxial anesthesia.
16021699|NCT02726620|Drug|Procaine|Local anesthetic used for central neuraxial anesthesia.
16021700|NCT02726620|Drug|Chloroprocaine|Local anesthetic used for central neuraxial anesthesia.
16021701|NCT02726620|Drug|Benzocaine|Local anesthetic used for central neuraxial anesthesia.
16021702|NCT02726620|Drug|Articaine|Local anesthetic used for central neuraxial anesthesia.
16021703|NCT02726607|Behavioral|HIV Infant Tracking System (HITSystem) 2.0|The HITsystem 2.0 intervention will be designed to: (1) utilize electronic prompts to notify providers and program managers when actions are required, and (2) send text messages to women's mobile phones to (a) motivate adherence to medication, (b) remind women of antenatal (ANC) appointments and medication refills, (c) prompt preparation for a hospital delivery, and (d) support early infant testing. Given advancements in the approach and protocols for care, HITSystem 2.0 will continue to engage mothers and encourage postnatal medication adherence. The researchers will design HITSystem 2.0 to integrate seamlessly into the existing HITSystem to link PMTCT and early infant diagnosis (EID) services through one coordinated system-level intervention.
16021902|NCT02725164|Drug|oxygen concentration|oxygen concentration will be measured in the tracheal tube and oropharynx during spontaneous or controlled ventilation
16021704|NCT02726607|Behavioral|Standard of PMTCT care|Pregnant women enrolled in PMTCT services at the control site will receive the current standard of PMTCT care and will not be enrolled in the HITSystem 2.0.
16021705|NCT02726581|Biological|Nivolumab|Specified dose on specified days, IV (intravenous)
16021706|NCT02726581|Biological|Elotuzumab|Specified dose on specified days, IV
16021707|NCT02726581|Drug|Pomalidomide|Specified dose on specified days, PO (by mouth)
16021708|NCT02726581|Drug|Dexamethasone|Specified dose on specified days, PO
16021709|NCT02726568|Drug|Icotinib|375 mg Tid (1125 mg per day) until intracranial PD.
16021710|NCT02726568|Radiation|SRS|If intracranial PD, then the subjects get stereotatic radiosurgery （30Gy/3f) combined with Icotinib 375mg Tid.
16021711|NCT02726555|Drug|Red yeast rice and atorvastatin|Participants will receive 2 capsules of 300mg red yeast rice and 2 capsules of 10mg atorvastatin for 24 weeks.
16021712|NCT02726555|Drug|Atorvastatin alone|Participants will receive 2 capsules of placebo and 2 capsules of 10mg atorvastatin for 24 weeks.
16021713|NCT02726542|Drug|somatropin|Norditropin (growth hormone) given by injection using a pen-device
16021714|NCT02726529|Behavioral|Brighter Bites|
16021715|NCT02726529|Behavioral|CATCH|The comparison schools received training in implementing the Coordinated Approach to Child Health (CATCH) school-based health promotion program
16021716|NCT02726516|Dietary Supplement|PRJ-205|1 sachet per day
16021717|NCT02726516|Other|Placebo|1 sachet per day
16021718|NCT02726503|Drug|Lenvatinib|"All patients will receive lenvatinib 24 mg orally once daily at almost the same time. The treatment will be started within 1 week after enrollment. 1 cycle consists of 4 weeks.
~The administration will be continued until patients meet withdrawal criteria. If any toxicity manifested that cannot be ruled out causal association with the study drug, drug withdrawal or dosage reduction will be conducted in accordance with drug withdrawal/dosage reduction criteria."
16021719|NCT02726490|Drug|Glyburide|glyburide 2.5milligrams (mg) at bedtime (qhs) increased as needed to a maximum of 20mg/day usually taken twice a day (BID)
16021720|NCT02726490|Drug|Glucovance|glucovance (2.5/500) 1 taken orally (PO) at bed time (QHS) increased as needed to a maximum dose of (20/2000)/day usually taken twice a day (BID)
16021721|NCT02726477|Drug|Wuling San|Patients will be administrated with Wuling San at a dosage of 1g/kg twice a day after randomisation.
16021722|NCT02726477|Drug|placebo|Patients will be administrated with placebo powder at a dosage of 1g/kg twice a day after randomisation.
16021723|NCT02726451|Other|Basic Skin Care|Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®)
16021724|NCT02726451|Other|Active Skin Care|Sensi Peel®, Rejuvenating Serum, and C&E Strength Max skin care products (PCA SKIN®) in addition to the Facial Wash, Hydrator Plus Broad Spectrum SPF 30, and Rebalance skin care products (PCA SKIN®)
16021725|NCT02726438|Drug|Debio 1450|Debio 1450, 40 mg, powder for oral solution, for reconstitution in 5% dextrose in water.
16021726|NCT02726425|Behavioral|Diabetes Self Management Medical Group Visits|The Women in Control DSM intervention involves: (1) 8-wk series of interactive, educational medical group visit sessions with groups of 10-12 participants, led by clinicians & peer leaders lasting ~100'' in length conducted either in Spanish or English and (2) Individual consultation with a clinician lasting 10-15 minutes. Group visits will consist of experiential and discussion based learning of topics including the importance of diet, physical activity, medications, mindfulness and stress reduction to diabetes self management.
16021727|NCT02726412|Procedure|Acute vs elective|non-intverention study
16021728|NCT02726399|Drug|Ramucirumab|Ramucirumab 8mg/kg administered intravenously on days 1 and 8 ever 21 days
16021729|NCT02726399|Drug|Trastuzumab|Trastuzumab (8 mg/kg loading dose; 6 mg/kg maintenance) administered intravenously every 21 days
16021730|NCT02726399|Drug|Capecitabine|Capecitabine 850mg/m2 will be added, taken orally twice a day for fourteen days (days 1 through 14) followed by a 7 day rest period
16021731|NCT02726399|Drug|Cisplatin|Cisplatin 80mg/m2 administered as an IV infusion every 21 days
16021732|NCT02726386|Drug|ND0612|ND0612, a solution of levodopa/carbidopa (LD/CD) delivered continuously subcutaneously (SC) via an infusion pump system
16021733|NCT02726373|Other|type of walking|Subjects walked either intermittently or continuously twice a week for 4 weeks, then crossed over
16021734|NCT02726360|Behavioral|survey|The ILR Scale, a non-English language proficiency self-assessment.
16021735|NCT02726360|Behavioral|Audio record|Audio record the initial visits between patients and their treating physician
16021736|NCT02726347|Biological|PPV-23|one hundred forty subjects will have pre-vaccination titers checked. All will be given vaccination as standard of care. Approximately 4 weeks later subjects will have post-vaccination titers checked for the same serotypes.
16021737|NCT02726334|Drug|BNC101 Solution for Infusion|Administration: Administered via IV infusion once a week over 60 minutes (1 hour).
16021738|NCT02726334|Drug|BNC101 in combination with FOLFIRI|"BNC101 - Starting dose as determined by Arm A portion (one dose level below recommended Phase 2 dose).
~BNC101 Administration: Administered via IV Infusion once a week over 60 minutes (1 hour).
~FOLFIRI components:
~Irinotecan (IRI) - Starting dose 180 mg/m2 (over 90 minutes on Day 1) Leucovorin (LV) - Starting dose 400 mg/m2 (administered over 120 minutes on Day 1 concurrently with IRI) 5-FU bolus - Starting dose 400 mg/m2 (administered after LV on Day 1, then) 5-FU infusion - Starting dose 2400 mg/m2 (administered over 48 hours starting on Day 1)
~FOLFIRI Cycles are repeated every 14 days."
16021739|NCT02726308|Drug|Dexamethasone|5 mg I.V. Dexamethasone just before induction
16021740|NCT02726308|Drug|10 ml/kg Ringer's lactate|Intra-operative 10 ml/kg Ringer's lactate solution .
16021741|NCT02726308|Drug|30 ml/kg Ringer's lactate|Intra-operative 30 ml/kg Ringer's lactate solution .
16021742|NCT02726295|Drug|E. coli Nissle 1917(Mutaflor®)|
16021743|NCT02726295|Drug|Placebo|
16021744|NCT02726269|Drug|CLA (Clarithro+Lanso+Amoxi)|Tablets of oral administration administered to subjects randomized to this group twice daily for 10 days.
16021745|NCT02726269|Drug|PLA (Panto+Levoflox+Azithro)|Tablets of oral administration to subjects randomized to this group once daily for 10 days.
16021900|NCT02725177|Drug|Repository Corticotropin Injection|"Treatment with ACTHAR Gel for 24 weeks
~Initial treatment with 80 units daily for ten days (induction phase)
~Maintenance treatment with 80 units twice weekly (maintenance phase)"
16098985|NCT02171052|Drug|Digoxin|
16021746|NCT02726230|Behavioral|Ananya|The Ananya program was developed and implemented via a partnership of the Bill and Melinda Gates Foundation and the Government of Bihar as a means of improving reproductive, maternal, newborn and child health (RMNCH) outcomes in the state, in particular focusing on improving health behaviors and service utilization in the final trimester of pregnancy and early postpartum period. Ananya was designed as a series of supply- and demand-side efforts to improve health. Efforts were focused on strengthening outreach services in quantity and quality, improving quality of facility services, and mobilizing communities to improve health behaviors. The Ananya program included training, mobilizing, and monitoring of government frontline health workers (FLWs, including anganwadi workers- AWWS, auxiliary nurse midwives- ANMs, and community health workers-ASHAs) to increase quantity and quality of home visits for RMNH screenings and services, and media messages to increase demand for services.
16021747|NCT02726217|Behavioral|CareSmarts Mobile Health Diabetes Program|Nurses from Diabetes Clinic will use a web-based enrollment form that includes the patient's mobile phone number, diabetes care plan, and preferred times for receiving messages. Participants in the program receive text messages about diabetes self-care. The contents of the messages that the participants receive are modified through software every two weeks as needed, based on their interactions with the system. Participants follow a flexible education curriculum in which they move from one topic to the next at their own pace.
16021748|NCT02726217|Behavioral|Standard of Care Reminders and Self Assessments|
16021749|NCT02726204|Other|Gravity Elimination Alone|CAREX will compensate for the gravity of the subject's arm, i.e. subject can move their arm to a specific position and relax all the arm muscles, CAREX will hold the arm in that configuration
16021750|NCT02726204|Other|Path Assistance Alone|CAREX will push subject's arm to a pre-specified path. If the arm is not in the path, CAREX will generate some force that is proportional to the distance between the hand and the path. The subject will feel like having a spring connected between his hand and the path
16021751|NCT02726204|Other|Path Assistance and Gravity Elimination|
16021752|NCT02726191|Behavioral|Spatial Match Exercise|
16021753|NCT02726191|Behavioral|Temporal Sequence Reconstruction Exercise|
16021754|NCT02726191|Behavioral|Token Task Exercise|
16021755|NCT02726191|Behavioral|Story Recall Exercise|
16021756|NCT02726191|Behavioral|Sample-Match (Within Modality) Exercise|
16021757|NCT02726191|Behavioral|Pair-Match (Across-Modality) Exercise|
16021758|NCT02726191|Behavioral|Triad-FiguresExercise|
16021759|NCT02726191|Behavioral|Monster Garden Exercise|
16021760|NCT02726191|Behavioral|Memory Match Exercise|
16021761|NCT02726191|Behavioral|Memory Matrix Exercise|
16021762|NCT02726191|Behavioral|Familiar Faces Exercises|
16021763|NCT02726191|Behavioral|Lost in Migration Exercise|
16021764|NCT02726191|Behavioral|Playing Koi Exercise|
16021765|NCT02726178|Drug|Advil® Pediatric drops for infants|Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants
16021766|NCT02726178|Drug|Placebo|Study the effect of inhibition of prostaglandins with ibuprofen vs placebo administration on cardio respiratory events in preterms infants
16021767|NCT02726152|Procedure|Polymer clips for closure of the appendiceal stump|Application of polymer clips to the appendiceal stump
16021768|NCT02726152|Procedure|Endoloops for closure of the appendiceal stump|Application of endoloops to the appendiceal stump
16021769|NCT02726126|Drug|Comparative study between transdermal fentanyl and melatonin patches on postoperative pain relief after lumber laminectomy|
16021770|NCT02726113|Drug|cholecalciferol|softgels 4000 IU daily for approximately two months prior to surgery (prostatectomy).
16021771|NCT02726113|Other|placebo|softgel containing no active ingredient daily for approximately two months prior to surgery (prostatectomy).
16021772|NCT02726100|Behavioral|SMARTHealth Diabetes|SMARTHealth Diabetes is an interactive mobile health platform to promote improved self-management for people with T2DM.
16021773|NCT02726087|Procedure|ministernotomy|"Partial upper J hemisternotomy trough 4th right intercostal space)"
16021774|NCT02726087|Procedure|Full sternotomy|Conventional full median sternotomy
16021775|NCT02726074|Drug|Perampanel|
16021776|NCT02726061|Behavioral|Internet-based psychological support|A behavioral therapy called Problem Solving Therapy, conflict management training, and stress management training will be administered via an interactive multimedia program (PATH) to participants referred from their Employee Assistance Program and the general public for the management of depression, stress, and conflict.
16021777|NCT02726048|Device|Simplus/Eson|Released product Simplus and Eson masks
16021778|NCT02726035|Drug|Naltrexone|oral naltrexone 50 mg daily
16021779|NCT02726035|Other|Placebo|oral placebo (appearing identical to naltrexone) once daily
16021780|NCT02726022|Drug|Peginterferon alfa-2a|As per treating physician discretion and according to summary of product characteristics.
16021781|NCT02726022|Drug|Ribavirin|As per treating physician discretion and according to summary of product characteristics.
16021782|NCT02726009|Drug|Degarelix|
16021783|NCT02725996|Biological|NK cells|Adjuvant adoptive immune therapy using NK cell 4 times
16021784|NCT02725996|Other|Curative therapy|Patients who had undergone curative treatment(surgical resection or radiofrequency ablation for HCC of pretreatment clinical stage I or II were eligible for this study with no adjuvant treatment
16021785|NCT02725983|Behavioral|SPT consultation|
16021786|NCT02725983|Device|SOPROCARE®|
16021787|NCT02725970|Other|survey|Cross-sectional survey
16021788|NCT02725957|Drug|Trehalose for IV Infusion|
16021789|NCT02725957|Drug|Saline 0.9% IV|
16021790|NCT02725944|Device|Implantation of ICRM|All patients will be implanted with ICRM in order to detect an occult PAF.
16021791|NCT02725931|Behavioral|Pulmonary rehabilitation (PR) plus PA-focused intervention|Patients will enrol in a 12-week PR program comprising exercise training (3 times per week) and psychosocial support and education sessions (once a week). Patients will also have their PA levels monitored on weeks (W) 1, 7 and 12 and receive feedback in the following weeks.
16021792|NCT02725918|Drug|Pemetrexed|500 mg/m2,iv,d1,q3w,until PD
16021793|NCT02725918|Drug|Cisplatin|75 mg/m2,iv,d1,q3w,×4 cycles
16022116|NCT02723916|Behavioral|ezParent Program|Tablet-based behavioral parent training program.
16021794|NCT02725905|Behavioral|Multi-Modal Education (MME)|"The MME curriculum focuses on developing weight management counseling (WMC) skills through several components: 1) a web course focused on WMC knowledge and clinical skill competencies; 2) WMC role-play exercises for an opportunity to use an algorithm to practice patient-centered WMC; 3) personal weight management exercises to increase awareness of Assist activities (e.g. daily food monitoring using mobile apps, etc); 4) obesity bias assessments, video, and discussions to modify attitudes of implicit weight bias; 5) a formative web-based encounter to interact with and receive feedback from a standardized patient; and 6) an enhanced clerkship rotation focusing on providing learning to preceptors and allowing students to observe preceptors counseling patients who are overweight or obese."
16021795|NCT02725905|Behavioral|Traditional Education (TE)|Current curriculum may consist of topics related to biology, population health, or counseling skills. TE also may include sporadic stand-alone lectures or small group discussions conducted separately or as a part of a patient interviewing or behavioral course.
16021796|NCT02725892|Other|NIS observational stud|NIS observational study : Epidemiologic registry
16021797|NCT02725866|Drug|Paritaprevir/ritonavir/ombitasvir|Co-formulated tablet
16021798|NCT02725866|Drug|Dasabuvir|Tablet
16021799|NCT02725866|Drug|Ribavirin|Tablet
16021800|NCT02725853|Device|tDCS|Application of 1.5 mA tDCS for 30 minutes
16021801|NCT02725853|Device|sham tDCS|Application of sham tDCS for 30 minutes
16021802|NCT02725853|Behavioral|personalized practice|arm exercise consisting of whole arm movement within a restricted elbow range of motion
16021803|NCT02725853|Behavioral|non-personalized practice|arm exercise consisting of unrestricted whole arm movement
16021804|NCT02725840|Radiation|Proton beam radiation therapy.|Proton bean radiation therapy interact differently with tissue with the result that protons are absorbed completely within the tissue instead of primarily passing through the entire body. The maximal depth of penetration is dependent upon the incoming velocity (energy) of the protons. Proton therapy utilizes this property to deliver radiation with very little dose beyond the targeted lesion. The dose-rate will be managed as part of the standard of care.
16021805|NCT02725840|Radiation|X-ray based radiation therapy|The three-dimensional (3D) mapping of radiation dose distributions permits detailed assessment of local vascular damage as a function of treatment factors of dose, dose-rate. The dose-rate will be managed as part of the standard of care.
16021806|NCT02725840|Procedure|Computed Tomography (CT) Scan|Computed Tomography (CT) Scan of the chest will be performed at 1, 3, 6, 12, 18 and 24 months
16021807|NCT02725840|Procedure|Pulmonary Function Test (PFT)|Pulmonary function test (PFT) will be performed at pre-treatment, and at 6 and 12 months.
16021808|NCT02725827|Other|EmbryoGlue (Vitrolife)|A hyaluronan-enriched embryo transfer medium
16021809|NCT02725827|Other|Control medium|The usual embryo transfer medium used in the study centres.
16021810|NCT02725814|Other|24% Sucrose Solution|Two minutes prior to the start of a painful procedure neonates will receive 0.12ml of 24% sucrose solution, over a period of no more than 1 minute. A pacifier will be offered immediately following sucrose administration for non-nutritive sucking if the infant is able to hold the pacifier securely. The sucrose study dose is to be repeated as needed based on pain response and procedure duration.
16021811|NCT02725801|Device|Allergen one-port tissue expander placement|patients will be randomized to receive a one port or two port tissue expander for breast reconstruction
16021812|NCT02725801|Device|AlloX2 two-port tissue expander placement|patients will be randomized to receive a one port or two port tissue expander for breast reconstruction
16021813|NCT02725788|Device|New PIV Dressing|A commercially available breathable, transparent film dressing with a soft-cloth border, notch and securement tape strip. The dressing system is used in the study to cover a peripheral intravenous catheter insertion site and secure the catheter. Dressing system is to remain in place until the PIV catheter is discontinued which is anticipated to be 72 hours. The dressing and PIV site will be observed daily. If dressing excessively lifts from the skin, the dressing system will be replaced with the same, assigned dressing system. The number of dressing replacements and the duration of wear will be measured while the same study PIV catheter dwells, an average of 72 hours during the subject's hospitalization.
16021814|NCT02725788|Device|Standard PIV Dressing|A commercially available breathable, transparent film dressing used with a one inch width piece of Transpore™ medical tape. The dressing system is used in the study to cover a peripheral intravenous catheter insertion site and secure the catheter. Dressing system is to remain in place until catheter is discontinued which is anticipated to be 72 hours. The dressing and PIV site will be observed daily. If dressing excessively lifts from the skin, the dressing system will be replaced with the same, assigned dressing system. The number of dressing replacements and the duration of wear will be measured while the same study PIV catheter dwells, an average of 72 hours during the subject's hospitalization.
16021815|NCT02725775|Dietary Supplement|100% Florida OJ|
16021816|NCT02725775|Dietary Supplement|Placebo Equicaloric Orange Drink|
16021817|NCT02725762|Device|LT-300 Active (PBM)|
16021818|NCT02725762|Device|LT-300 Inactive (Sham)|
16021819|NCT02725749|Radiation|Laser|Laser used were GaAs (904 nm, 60 mW), in continuous emission. The participants received application of laser three times or week for eight weeks, on 9 shoulder points (3 Joules/point) per session.
16021820|NCT02725749|Other|EXE|"Isotonic strengthening exercises were performed for the scapular pivot, scapula stabilizer, and humeral propellant muscle groups. Three sets of 15 repetitions of each isotonic strengthening exercise were performed. The isometric exercises were performed in ten sets of ten seconds each. Analytical stretching of each muscle group was performed at the beginning of the session for 30 seconds.
~The participants performed the exercises three times a week for eight weeks."
16021821|NCT02725749|Radiation|Laser + EXE|"Laser used were GaAs (904 nm, 60 mW), in continuous emission. The participants received application of laser three times or week for eight weeks, on 9 shoulder points (3 Joules/point) per session.
~Isotonic strengthening exercises were performed for the scapular pivot, scapula stabilizer, and humeral propellant muscle groups. Three sets of 15 repetitions of each isotonic strengthening exercise were performed. The isometric exercises were performed in ten sets of ten seconds each. Analytical stretching of each muscle group was performed at the beginning of the session for 30 seconds.
~The participants performed the exercises three times a week for eight weeks."
16021901|NCT02725177|Drug|Repository Corticotropin Injection -Treatment Extension|24 open label extension permitted in subjects who respond to treatment
16021822|NCT02725736|Drug|Atosiban|"After random allocation to a treatment group, women will receive Atosiban as follows:
~Atosiban was given as a single loading intravenous dose, 6.75 mg in 0.9% sodium chloride solution, followed by an intravenous infusion of 300 micrograms/min in 0.9% sodium chloride solution for the first 3 hours and then 100 micrograms/min for another 45 hours. The choice of the dose regimen for Atosiban was consistent with the recommendations of the product labeling."
16021823|NCT02725736|Drug|Nifedipine|"After random allocation to a treatment group, women will receive Nifedipine as follows:
~Nifedipine was given as a loading dose of 20 mg orally followed by another two doses of 20 mg, 20-30 minutes apart as needed. Maintenance was started after 6 hours with 20-40 mg four times a day for a total of 48 hours."
16021824|NCT02725723|Device|Therm-AppTM TH, thermographic camera|
16021825|NCT02725723|Drug|epidural injection|
16021826|NCT02725710|Drug|Gabapentin|600mg Gabapentin administered orally 1-2 hours prior to procedure
16021827|NCT02725710|Drug|Placebo|Identical looking pill to the 600mg Gabapentin pill administered orally 1-2 hours prior to procedure
16021828|NCT02725697|Other|TCM treatment|
16021829|NCT02725684|Other|Observational study, no intervention|Observational study, no intervention
16021830|NCT02725671|Device|Explorer|ECG device which records comprehensive voltage potential data in the myocardium
16021831|NCT02725658|Device|DOSI|Breast tissue properties scanning
16021832|NCT02725645|Other|loading conditions|Different backpack loading conditions 0%, 10%, 15% and 20% allocated randomly
16021833|NCT02725632|Device|CPAP|The patients on CPAP treatment will be followed-up for 1 month.
16021834|NCT02725619|Behavioral|CBT|
16021835|NCT02725619|Behavioral|PST|
16021836|NCT02725606|Biological|Pegylated Recombinant Human G-CSF|subcutaneous
16021837|NCT02725606|Biological|GW003|subcutaneous
16021838|NCT02725593|Drug|Dapagliflozin|Dapagliflozin 10 mg tablets administered orally once daily, for the 24-week blinded treatment period. Dapagliflozin 10mg tablets administered orally once daily, for the 28-week site and subject blinded long term extension.
16021839|NCT02725593|Drug|Dapagliflozin placebo|matching placebo tablets, administered orally once daily, for the 24-week blinded treatment period. Dapagliflozin 10mg tablets administered orally once daily,for the 28-week site and subject blinded long term extension.
16021840|NCT02725580|Genetic|AT-GTX-501|CLN6 Gene delivered by Self-Complementary AAV9
16021841|NCT02725567|Drug|ivacaftor|
16021842|NCT02725554|Device|StimRelieve Halo System|The StimRelieve Halo System is intended as the sole mitigating agent, or as an adjunct to other modes of therapy used in a multidisciplinary approach for chronic migraine as defined by the Third edition of the International Classification of headache disorders (ICDH-3). The system provides treatment by delivering small controlled electrical pulses to the occipital and supraorbital nerves, as it has been shown that for chronic migraine headaches the response to combined systems appears to be substantially better than occipital nerves stimulation alone.
16021843|NCT02725541|Drug|Trastuzumab emtansine|HER2-targeted antibody drug conjugate of trastuzumab and DM1
16021844|NCT02725528|Drug|collagenase injection|injection
16021845|NCT02725528|Procedure|limited palmar fasciectomy|surgery
16021846|NCT02725515|Biological|XmAb5871|
16021847|NCT02725515|Biological|Placebo to match XmAb5871|
16021848|NCT02725502|Drug|Linagliptin|Baseline HbA1C will be assessed. Before starting treatment with linagliptin or placebo Mixed meal test will be conducted with the standard protocol. Morning dose of insulin to be omitted on the day of mixed meal test. During the mixed meal test glucose, C-peptide, GLP1 and glucagon will be measured at 0, 30, 60, 120, 180 minutes. 72 hour blood glucose profile to be monitored with continuous glucose monitoring system (CGMS). Markers of glucose control and glucose variability will be measured. Then we will randomly divide these patients in two group (linagliptin and placebo group). After 3 month period 72 hour blood glucose profile, HbA1C and Mixed meal test will be repeated to document any change in blood glucose profile.
16021849|NCT02725502|Drug|Placebo|Baseline HbA1C will be assessed. Before starting treatment with linagliptin or placebo. Mixed meal test will be conducted with the standard protocol. Morning dose of insulin to be omitted on the day of mixed meal test. During the mixed meal test glucose, C-peptide, GLP-1 and glucagon will be measured at 0, 30, 60, 120, 180 minutes. 72 hour blood glucose profile to be monitored with CGMS. Markers of glucose control and glucose variability will be measured. Then we will randomly divide these patients in two group (linagliptin and placebo group). After 3 month period 72 hour blood glucose profile, HbA1C and Mixed meal test will be repeated to document any change in blood glucose profile.
16021850|NCT02725489|Biological|Vigil|Vigil is made up of irradiated autologous tumor cells which have been electroporated ex vivo with the Vigil plasmid designed to suppress expression of both the TGFβ1 and TGFβ2 proteins while simultaneously expressing rhGMCSF protein.
16021851|NCT02725489|Drug|Durvalumab|A human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody directed against programmed cell death ligand 1 (PD-L1)
16021852|NCT02725476|Biological|XmAb5871|
16021853|NCT02725463|Device|Labyrinth Devices MVI™ Multichannel Vestibular Implant|
16021854|NCT02725450|Behavioral|Motor Imagery + Psychomotor Battery of fine motor skills|Subjects were randomly divided in two groups: a control group and an experimental one. The study procedures were applied on five different tasks of the Psychomotor Battery of fine motor skills (BPM). This instrument was applied in two stages, at the beginning of the study (pretest) and at the end of the 4 weeks (posttest). Both groups performed the tasks twice a week for a month. Motor imagery sessions were added on in the experimental group. Participants on the experimental group were asked to mentally imagine themselves recreating tasks they had performed earlier on the initial assessment.
16021855|NCT02725450|Behavioral|Psychomotor Battery of fine motor skills Practice|Subjects were randomly divided in two groups: in the control group were applied on five different tasks of the Psychomotor Battery of fine motor skills (BPM). This instrument was applied in two stages, at the beginning of the study (pretest) and at the end of the 4 weeks (posttest). Both groups performed the tasks twice a week for a month.
16021856|NCT02725437|Biological|Clostridium difficile Vaccine|0.5 mL intramuscular injection
16021857|NCT02725437|Biological|Placebo|0.5 mL intramuscular injection
16021858|NCT02725424|Drug|S-1|Her-2 Positive patients with SOX Oxaliplatin： 130 mg/m2, iv, d1 S-1： 80mg(Body Surface Areas<1.25m2) , 100mg(Body Surface Areas>1.25m2, <1.5 m2), 120 mg／day(Body Surface Areas>1.5m2), po,Bid， d1-14 Every 3weeks.
16021859|NCT02725424|Drug|Trastuzumab|Her-2 positive patients with SOXT Oxaliplatin： 130 mg/m2, iv, d1 S-1： 80mg(Body Surface Areas<1.25m2) , 100mg(Body Surface Areas>1.25m2, <1.5 m2), 120 mg／day(Body Surface Areas>1.5m2), PO,BID， d1-14 Trastuzumab :6 mg/kg, iv, d1 ：8 mg/kg Every 3weeks.
16021860|NCT02725424|Drug|Oxaliplatin|HER-2 Negative Patients：SOX Oxaliplatin： 130 mg/m2, iv, d1 S-1： 80mg(Body Surface Areas<1.25m2) , 100mg(Body Surface Areas>1.25m2, <1.5 m2), 120 mg／day(Body Surface Areas>1.5m2), PO,BID， d1-14 Every 3 weeks
16021861|NCT02725424|Drug|Docetaxel|Her-2 Negative patients with DOS Docetaxel： 60 mg/m2, iv, d1 Oxaliplatin：100 mg/m2, iv, d1 S-1 60 mg/m2，po，Bid， d1-14 Every 3 weeks
16021862|NCT02725411|Drug|Celecoxib|Orally administered Celecoxib 100 mg twice daily for 56 weeks
16021863|NCT02725411|Biological|Tanezumab 5 mg|Subcutaneous injection of tanezumab 5 mg every 8 weeks for 56 weeks
16021864|NCT02725411|Biological|Tanezumab 10 mg|Subcutaneous injection of tanezumab 10 mg every 8 weeks for 56 weeks
16021865|NCT02725411|Drug|Placebo for celecoxib|Orally administered the placebo twice daily for 56 weeks
16021866|NCT02725411|Biological|Placebo for tanezumab|Subcutaneous injection of the placebo every 8 weeks for 56 weeks
16021867|NCT02725398|Drug|Buscopan|Buscopan is administered by endoscopic nurse in the Buscopan group,and then recording the outcome measures.
16021868|NCT02725398|Drug|Scopolamine|Scopolamine is administered by endoscopic nurse in the Scopolamine group,and then recording the outcome measures.
16021869|NCT02725398|Drug|physiological saline|Physiological saline is administered by endoscopic nurse in the physiological saline group,and then recording the outcome measures.
16021870|NCT02725385|Other|Laboratory Biomarker Analysis|Correlative studies
16021871|NCT02725385|Other|Physiologic Testing|Undergo Trier Social Stress Test
16021872|NCT02725385|Other|Questionnaire Administration|Complete questionnaire
16021873|NCT02725372|Drug|Inhaled Nitric Oxide 75 mcg/kg IBW/hr|Inhaled Nitric Oxide 15mcg/Kg IBW/hr for two week run in period dose titrated to Inhaled Nitric Oxide 75 mcg/kg IBW/hr at randomizationTreatment Period (Week 3 to Week 18)
16021874|NCT02725372|Drug|Placebo|Part 1 Placebo arm: Inhaled Nitric Oxide 15mcg/Kg IBW/hrfor two week run in period dose titrated to Inhaled Nitric Oxide 75 mcg/kg IBW/hr at randomizationTreatment Period
16021875|NCT02725359|Drug|Placebo|Group Placebo: will receive a placebo pill 1 hour before surgery
16021876|NCT02725359|Drug|Tizanidine|Group T: 6 mg tizanidine1 hour before surgery
16021877|NCT02725359|Drug|Bupivacaine|Group Bupivacaine will receive USG guided SCPB with %0,25 bupivacaine bilaterally 10 ml each side
16021878|NCT02725359|Drug|Saline|USG guided SCPB with saline bilaterally 10 ml each side
16021879|NCT02725346|Procedure|Acromioplasty with planning|
16021880|NCT02725346|Procedure|Acromioplasty without planning|
16021881|NCT02725333|Procedure|Shoulder Stabilization|Open Latarjet was performed as the standard and well-described Latarjet-Patte procedure with subscapularis split and triple locking mechanism.14 The graft was intra-articular in every case, the capsule was systematically reattached to glenoid according to Favard's modification,15 and a capsular shift was added. Arthroscopic Latarjet was carried out in one case according to a modified Lafosse technique.16 In the latter treatment option, no reattachment of the capsule was realized. The arthroscopic Bankart repair consisted in a mobilization of the anteroinferior capsule and the labrum with an arthroscopic elevator. The glenoid rim and neck were then prepared with a mechanical shaver device. Two loaded anchors were inserted at the 5 and 3 o'clock position, and sutures were shuttled across the inferior glenohumeral ligament and labrum, starting at the inferior position and progressing in a superior direction.
16021882|NCT02725307|Device|Noninvasive pulse wave analysis sensor, ECG-sensor|Noninvasive pulse wave sensors and ECG-sensors are attached
16021883|NCT02725294|Other|This is an observational study without an intervention|Not applicable. This is an observational study without an intervention.
16021884|NCT02725281|Other|Stress ball|The patients in this group were given stress ball into their both palms 5 min before the lithotripsy and told to squeeze the ball whenever they would like until end of the process. This ball was medium hard and has been made of high quality silicon.
16021885|NCT02725281|Other|Music|The patients in this group were also listened to the music chosen by them with a headset from 5 min before until the end of lithotripsy. Types of music played for the patients were Turkish folk music, Turkish art music, Turkish arabesque music, Turkish pop music, foreign pop music, rock music, and classical music.
16021886|NCT02725268|Drug|Paclitaxel|Paclitaxel intravenous solution.
16021887|NCT02725268|Drug|Sapanisertib|Sapanisertib capsules.
16021888|NCT02725268|Drug|MLN1117|MLN1117 capsules.
16021889|NCT02725255|Dietary Supplement|Ujiplus|Maize flour fortified with micronutrients and dried ground papaya (Carica papaya) seeds. The flour was used to prepare porridge and each child given a serving of 300 ml every school day for 60 days.
16021890|NCT02725255|Drug|Albendazole|400mg of albendazole given to each child once at the beginning of the study and maize flour porridge fortified only with micronutrients cooked and served to each child, 300ml per day for 60 days.
16021891|NCT02725255|Dietary Supplement|uji|maize flour porridge fortified only with micronutrients, cooked and served to each child 300ml per day for 60 days.
16021892|NCT02725242|Drug|Budesonide/formoterol (160/4.5 μg/d)|After the patients who have all criteria, they will be randomization to take Budesonide/formoterol (160/4.5 μg/d)
16021893|NCT02725242|Drug|Budesonide (400μg/d)|After the patients who have all criteria, they will be randomization to take Budesonide (200 ug) twice daily
16021894|NCT02725229|Procedure|parasternal block|parasternal block and PCA for sternotomy pain
16021895|NCT02725229|Device|TENS group|TENS and PCA for sternotomy pain
16021896|NCT02725229|Device|control group|PCA for sternotomy pain
16021897|NCT02725203|Behavioral|Activate|The Activate intervention consists of four nurse-led consultations in a thee-month period. In the consultations patients receive structured and comprehensive support in achieving an improved level of physical activity. The Behavior Change Wheel was used to develop the Activate intervention, and led to a selection of 17 behavior change techniques, which are integrated in the Activate intervention
16021898|NCT02725190|Behavioral|Sleepless night|Each subject will undergo 28 hours of sleep deprivation.
16021899|NCT02725190|Behavioral|Normal sleep night|Normal sleep at home before trial.
16022316|NCT02722447|Drug|Placebo|Placebo for 6 weeks
16021903|NCT02725164|Drug|nitrous oxide concentration|nitrous oxide concentration will be measured in the tracheal tube and oropharynx during spontaneous or controlled ventilation
16021904|NCT02725164|Drug|carbon dioxide concentration|carbon dioxide concentration will be measured from the tracheal tube and in the oropharynx during spontaneous or controlled ventilation
16021905|NCT02725164|Drug|sevoflurane concentration|sevoflurane concentration will be measured in the tracheal tube and oropharynx during spontaneous or controlled ventilation
16021906|NCT02725138|Dietary Supplement|Probiotic|Probiotic containing Lactobacillus acidophilus and Lactobacillus rhamnosus produced by the Taiwan Sugar Cooperation, 1pack, twice daily, for 4 weeks
16021907|NCT02725138|Other|Placebo|Placebo without Lactobacillus acidophilus and Lactobacillus rhamnosus produced by the Taiwan Sugar Cooperation, 1pack, twice daily, for 4 weeks
16021908|NCT02725125|Biological|EPCAM-targeted CAR-T cells|This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-EPCAM-modified T cells can recognize and kill tumor cells in the body，follow-up 35 months.
16021909|NCT02725112|Drug|Pregabalin ER|A: Pregabalin ER tablet formulation, Target release rate, 1 x 330 mg, Oral.
16021910|NCT02725112|Drug|Pregabalin ER|B: Pregabalin ER tablet formulation, Slow release rate, 1 x 330 mg, Oral.
16021911|NCT02725112|Drug|Pregabalin ER|C: Pregabalin ER tablet formulation, Fast release rate, 1 x 330 mg, Oral.
16021912|NCT02725112|Drug|Pregabalin ER|D: Pregabalin IR capsule formulation, 1 x 300 mg, Oral.
16021913|NCT02725112|Drug|Pregabalin ER|E: Pregabalin ER tablet formulation, Target release rate, 1 x 82.5 mg, Oral.
16021914|NCT02725112|Drug|Pregabalin ER|F: Pregabalin ER tablet formulation, Aberrant fast release rate, 1 x 330 mg, Oral.
16021915|NCT02725099|Drug|Chewing Ticagrelor|180 mg Chewing Ticagrelor
16021916|NCT02725099|Drug|Oral Ticagrelor|180 mg oral Ticagrelor
16021917|NCT02725086|Drug|Leucostim®|
16021918|NCT02725086|Drug|Neupogen®|
16021919|NCT02725073|Procedure|Photodynamic therapy|Photolon (Belmedpreparaty, Minsk, Republic of Belarus), was administered intravenously at a dose of 2.5 mg/kg at 3 hours before illumination. After advancing a catheter (7 F inner sheath of a plastic stent delivery catheter [MAJ-1419; Olympus America, Center Valley, Pa., USA]) across the biliary stricture using a 0.035-in guidewire, the cylindrical diffuser is inserted into a catheter at the level of the stricture to be treated. Photoactivation (660 nm with a light dose of 100-150J/cm2, and fluence of 0.8-1W/cm2; UPL- FDT; LEMT Research & Development Private Unitary Enterprise, Minsk, Republic of Belarus) is performed
16021920|NCT02725060|Drug|phenylephrine|Phenylephrine is a selective α1-adrenergic receptor agonist. It will be given in IV bolus injections starting from 12.5 ug. Incremental doses will be given every ~3 min up to 800 ug or until systolic blood pressure increases by 25 mmHg
16021921|NCT02725060|Drug|isoproterenol|Isoproterenol is non-selective beta-adrenergic agonist. It will be given in IV bolus injections starting from 0.025 ug. Incremental doses will be given every ~3 min until heart rate increases by 25 bpm. This intervention is optional.
16021922|NCT02725060|Radiation|25 micro-Ci of radiation|Using injection of iodinated I-131 tagged human serum albumin nominally 25 micro-Ci of radiation, blood samples are drawn before and 30 minutes after injection.
16021923|NCT02725060|Procedure|Posture study with blood samples|Blood pressure and heart rate will be measured while supine and then while standing for up to 30 minutes. Blood will be drawn in each position to measure hormones that regulate blood pressure and blood volume. An additional sample will be collected in the supine position for the autoantibody assessment.
16021924|NCT02725060|Procedure|24-hour heart rhythm and blood pressure monitoring|Blood pressure, heart rate and ECG monitoring for 24 hours
16021925|NCT02725060|Procedure|Quantitative Axonal Sudomotor Reflex Testing|The QSART assesses the ability of sympathetic nerve terminals in the skin to release acetylcholine and increase sweat production. The test is performed at 4 sites over the forearm, proximal lateral leg, medial distal leg and proximal foot.
16021926|NCT02725060|Procedure|Autonomic function tests|The autonomic function tests will determine how well the autonomic nervous system regulates blood pressure and heart rate. These tests include breathing deeply for two minutes, breathing fast for 30 seconds, maintaining a handgrip for 3 minutes, breathing against pressure for 15 seconds, and placing the hand in ice water for 1 minute. In addition, participants will be tilted up on a tilt table for up to 10 minutes while recording their heart rate, blood pressure and cardiac output.
16021927|NCT02725060|Other|Rebreathing test|Cardiac output will be measured using the rebreathing technique (Innocor)
16021928|NCT02725060|Other|Assessment of splanchnic capacitance|Splanchnic capacitance will be assessed using cpap and body impedance to construct pressure volume curves
16021929|NCT02725060|Procedure|microneurography|microneurography will be measured in the peroneal nerve to assess sympathetic activity.
16021930|NCT02725047|Other|Cryotherapy|Crushed ice (1kg) inside a plastic bag (24x34x0,08 cm). The positioning of the plastic bags will cover the entire knee surface (Anterior, lateral and posterior region). After the positioning of the ice bags, they will be fixed with an elastic bandage (compression). To protect the skin against frost bites, all the knee surface will be covered with a moistened operative field (45x50x0,01 cm, 100% cotton)
16021931|NCT02725047|Other|Placebo - Sand|Sand (1kg) inside a plastic bag (24x34x0,08 cm). The positioning of the plastic bags will cover the entire knee surface (Anterior, lateral and posterior region). After the positioning of the sand bags, they will be fixed with an elastic bandage (compression). Also, all the knee surface will be covered with a moistened operative field (45x50x0,01 cm, 100% cotton) to mimic the experimental group.
16021932|NCT02725034|Device|Standard endoscopy|
16021933|NCT02725034|Device|High definition endoscopy with Optic Enhancement|
16021934|NCT02725021|Behavioral|Education Against Tobacco school-based intervention by medical students|
16021935|NCT02725008|Drug|Dexamethasone|
16021936|NCT02725008|Drug|placebo|to be given to the experimental group on the day after discharge from the ED in lieu of the second dose of dexamethasone
16021937|NCT02724969|Behavioral|MILK or Text4Baby text message intervention|MILK text message intervention encompasses prenatal and postpartum breastfeeding support and education text messages. Text4Baby text message intervention encompasses prenatal and postpartum text messages about pregnancy, infant care, and postpartum issues.
16022117|NCT02723916|Behavioral|Health-e Kids Control App|Tablet based health promotion information App
16021938|NCT02724956|Device|Ambu AuraGain|Pre-curved, rigid airway tube, SGAD. Third generation Ambu laryngeal mask satisfying 3 fundamental airway management needs by integrating gastric access and intubation capability in an anatomically curved single-use device that facilitates rapid establishment of a safe airway. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.
16021939|NCT02724956|Device|Teleflex LMA Protector|Pre-curved, rigid airway tube, SGAD: A next-generation, single-use laryngeal mask with a dual gastric drainage channel and pharyngeal chamber. A SGAD used for ventilation, and a conduit for intubation. SGAD insertion followed by fiber-optic evaluation using Ambu aScope.
16021940|NCT02724956|Device|Ambu aScope|Flexible scope which will be introduced into airway tube and guided through the SGAD until it will be possible to view the vocal cords. Description of the maximal optical view will be measured by the Percentage of Glottic Opening (POGO).
16021941|NCT02724943|Behavioral|BMI screening|Physician screening of patients to identify patients who are overweight or obese.
16021942|NCT02724943|Behavioral|Next Steps brief clinical intervention|This intervention included identification of children who were overweight or obese, and Next Steps brief counseling materials for the healthcare provider (prior to enrollment in the intervention).
16021943|NCT02724943|Behavioral|MEND/CATCH|MEND 2-5 and MEND/CATCH 6-12 programs are multi-component interventions including behavioral, nutrition, and physical activity sessions. In the intensive (first 3 months) phase, MEND 2-5 entailed nine weekly sessions and MEND 6-12 entailed 18 twice weekly sessions.
16021944|NCT02724943|Behavioral|MEND/CATCH Transition Phase|The transition phase (next 9 months of the 12-month program) included monthly 90-minute sessions for parents and children included MEND reviews, cooking classes, Being Well book, CATCH activities and MEND World activities. Children were enrolled in YMCA sports teams or programs offered twice weekly to encourage physical activity. Weekly text messages were sent to parents to reinforce behavioral objectives of the intervention.
16021945|NCT02724943|Behavioral|Next Steps Self-Paced Booklet|Next Steps booklet for parents and children to work on nutrition and physical activity targets in a self-directed manner. Families were encouraged to seek repeated clinical visits to address child obesity as a follow up to the self-paced booklet.
16021946|NCT02724930|Behavioral|Enhanced facilitation of COPES|Enhanced facilitation of COPES implementation consists of promotional meetings, automated case finding and proactive outreach to recruit patients, marketing and educational materials, local champion, and academic detailing.
16021947|NCT02724917|Drug|APN1125|Oral solid dose form of APN1125
16021948|NCT02724917|Drug|Placebo|Placebo to match
16021949|NCT02724904|Procedure|Allogeneic stem cell transplantation|Reduced intensity allogeneic stem cell transplantation from a fully matched related or unrelated donor
16021950|NCT02724904|Drug|Fludarabine|Standard Treatment
16021951|NCT02724904|Drug|Thiotepa|Standard Treatment
16021952|NCT02724904|Drug|Methotrexate|IV Bolus
16021953|NCT02724891|Other|paper form|questionnaires in paper form
16021954|NCT02724891|Other|web/smartphone form|questionnaires in web/smartphone
16021955|NCT02724878|Drug|Bevacizumab|
16021956|NCT02724878|Drug|Atezolizumab|
16021957|NCT02724865|Device|Somnodent® (Oral appliance therapy)|
16021958|NCT02724865|Device|Herbst® (Oral appliance therapy)|
16021959|NCT02724852|Biological|0.5 ml of MMR vaccine|Participants in each arm received the same vaccine, a 0.5 ml of MMR vaccine at deltoid region
16021960|NCT02724839|Behavioral|Group nutrition sessions|The intervention will consist of 6 nutrition group sessions co-led by parent and a professional from the community who will rotate at each session. Group nutrition sessions will consist of a facilitated discussion of benefits and barriers to healthy eating, a short lesson led by the content expert, and a fun game or activity to reinforce the lesson. Three non-concurrent phases of the study will compare the efficacy of the group sessions when offered biweekly (Arm 1), monthly (Arm 2) and weekly (Arm 3).
16021961|NCT02724839|Device|Fitbit|Parent and child dyads will each receive a Fitbit Flex wearable device at the second session. This device will be used by participants and investigators to motivate and track participants' physical activity for up to 9 months.
16021962|NCT02724826|Behavioral|Qigong therapy|Medical qigong
16021963|NCT02724826|Behavioral|Exercise therapy|Regular exercise
16021964|NCT02724813|Behavioral|Cognitive Orientation to Occupational Preformance (COOP)|
16021965|NCT02724800|Behavioral|CBTI|28 Veterans with chronic insomnia will be randomized to CBTI. The intervention will be delivered in 5 face-to-face session within an 8 week time period. The intervention will be delivered at the VA Pittsburgh Healthcare System. Treatment visits will last approximately 45 minutes.
16021966|NCT02724800|Behavioral|BBTI|28 Veterans with chronic insomnia will be randomized to BBTI. The intervention will be delivered over 4 consecutive weeks, which include individual face-to-face visits on Weeks 1 and 3 (option for telephone), and telephone appointments on Weeks 2 and 4. Interventions will be delivered at the VA Pittsburgh Healthcare System. The duration of the first treatment visit is approximately 45-minutes, and the follow-up visit on Week 3 will last no more than 30 minutes. Brief (<20 minutes) telephone sessions will be conducted on Weeks 2 and 4.
16021967|NCT02724787|Behavioral|Manage Emotions to Reduce Aggression (MERA)|MERA is a 3-session group treatment that teaches Veterans the purpose of emotions, how trauma and combat can increase emotions, and how to better regulate them. The skills use cognitive-behavioral and mindfulness techniques to help Veteran better regulate their emotions. These skills are commonly used in clinical practice, but have not been delivered in 3 sessions.
16021968|NCT02724774|Behavioral|Promoting First Relationships®|"PFR is based on attachment theory and is strengths-based. The 10 week intervention is delivered in the home of the family. Each week has a theme for discussion, handouts, an activity, and time for joining - checking in with the parent, listening to her concerns, and establishing a positive, supportive relationship. The PFR provider videotapes playtime between parent and child, and alternates every other week with watching the video with the parent, reflecting about the needs of both parent and child. The provider helps the parent develop greater empathy and understanding of the child's needs and feelings, and helps the parent to identify her own feelings and needs around parenting."
16021969|NCT02724761|Drug|Racemic Epinephrine|1 inhalation of 0.5 mL of 2.25% Nebulized Racemic Epinephrine every 8 hours for 24 hours after surgery
16022118|NCT02723903|Drug|Deanxit|we use Deanxit for the patient with anxiety
16021970|NCT02724761|Drug|Placebo (for racemic epinephrine)|0.5 mL of normal saline will be prepared in an identical amber syringe as the drug intervention (racemic epinephrine)
16021971|NCT02724748|Behavioral|Educational intervention|Educational intervention for staff members will encourage collaboration between patients, relatives and staff members. Skills, intellectual resources, motivation and encouragement among staff members to make changes on the unit will be supported. More detailed content of the intervention to be used in each unit will be tailored based on preparatory phase of the study and individual needs of the unit. The educational intervention will be carried out beside usual care.
16021972|NCT02724735|Drug|NSI-189|0 Milligrams, 40 Milligrams or 80 Milligrams administered in the acute study only
16021973|NCT02724722|Behavioral|Assigned intervention|a simple flyer plus face-to-face health education and give one bag containing stainless steel-made tableware for eating out use
16021974|NCT02724722|Behavioral|No intervention|a simple flyer only with no face-to-face health education and give one bag not containing stainless steel-made tableware for eating out use
16021975|NCT02724709|Procedure|Three-dimensional transoesophageal echocardiography|Three-dimensional transoesophageal echocardiography, analysed by eSie valve software (Siemens)
16021976|NCT02724709|Procedure|Computed tomography|Computed tomography, analysed by Synovia Workstation (Siemens)
16021977|NCT02724683|Device|Ascites drainage with vascular catheter.|In case of symptomatic malignant ascites, the procedure of vascular catheter insertion into abdominal cavity will be performed, followed by slow, systematic drainage, on patient's demand.
16021978|NCT02724683|Behavioral|Interview.|Interview with patients will be performed according to attached chart. The aim is to collect data concerning patient's symptoms, co-morbidity, and basic clinical data about the primary malignancy and treatment status.
16021979|NCT02724683|Behavioral|Quality of life.|Quality of life questionnaire (QLQ). Patients will be asked to complete QLQ at two time points: 1. immediately before the procedure, 2. one or two weeks after the procedure.
16021980|NCT02724683|Device|Quality of procedure.|Patients will be asked to complete quality of procedure questionnaire at one time point: one or two weeks after the procedure.
16021981|NCT02724683|Other|Nutritional status|Risk of malnutrition and ability to feed normally will be assessed with specific questionnaire at two time points: 1. immediately before the procedure, 2. one or two weeks after the procedure.
16021982|NCT02724670|Radiation|IGRT|MR-based IGRT
16021983|NCT02724657|Other|Buteyko Method|Intervention will be held twice a week during 3 weeks.
16021984|NCT02724644|Biological|COLLAGENASE CLOSTRIDIUM HISTOLYTICUM|Injectable intervention
16021985|NCT02724644|Biological|Placebo Comparator|
16021986|NCT02724631|Device|TubeClear® intervention|The TubeClear® device is deemed by the Food and Drug Administration (FDA) to be non-significant risk (NSR) for use in this study. It is a control box and a single use clearing stem used to resolve the clog in an enteral access device within five minutes following the intervention.
16021987|NCT02724618|Drug|Curcumin|120mg/d oral nanocurcumin (3 capsules of SinaCurcumin®40 per day) 3 days before and during radiotherapy
16021988|NCT02724618|Radiation|RT|EBRT is delivered as Intensity-Modulated Radiation Therapy (IMRT) or 3D-conformal RT
16021989|NCT02724618|Drug|Placebo|Placebo (3 placebo capsules of SinaCurcumin®40 per day), 3 days before and during radiotherapy
16021990|NCT02724605|Biological|Red blood cells unit age 14 days or less|30 Patients who will receive units of packed red blood cells stored stored for 14 days or less
16021991|NCT02724605|Biological|Red blood cells unit age more than 14 days|30 patients who will receive units of packed red blood cells stored for more than 14 days
16021992|NCT02724592|Device|self assembling peptide P11-4 (Curodont™ Repair)|Applying of self assembling peptide P11-4 (Curodont™ Repair) on teeth with initial caries lesions
16021993|NCT02724592|Device|fluoride varnish (Duraphat®)|Applying fluoride varnish (Duraphat®) on teeth with initial caries lesions
16022001|NCT02724566|Drug|apelin|Assessing the difference between the insulin sensitivity measured during hyperinsulinemic euglycemic clamps in the presence of a 2 hours continuous infusion of (PYR1)-apelin-13 (30nmol/kg) versus a 2 hours continuous infusion of placebo (vehicle alone).
16022002|NCT02724566|Drug|placebo|2 hours continuous infusion of placebo (vehicle alone) to compare with 2 hours infusion of apelin
16022003|NCT02724553|Device|Acrylic lens implantation|
16022004|NCT02724540|Device|Bland Embolization|Lobar or segmental bland embolization with microspheres (50-500 microns) to 2-5 heartbeat stasis
16022005|NCT02724540|Combination Product|Transarterial chemoembolization|Lobar or segmental lipiodol transarterial chemoembolization. Doxorubicin 50 mg dissolved in 10 mL dilute contrast and emulsified with 10-20 cc iodized oil, followed by 50-500 μm microspheres.
16022006|NCT02724540|Combination Product|Drug Eluting Beads Embolization|CLOSED - Lobar or segmental hepatic chemoembolization with DEBDOX (100-300 or 300-500 micron beads loaded with doxorubicin per manufacturer IFU.
16022007|NCT02724527|Drug|Cavosonstat|CFTR modulator that stabilizes CFTR
16022008|NCT02724527|Drug|Placebo|Matched Placebo capsule
16022009|NCT02724514|Other|non-invasive image & bioimpedance based techniques|Ultrasound scans, bioimpedance measurements, clinical photographs and questionnaires will be performed before and after the massage.
16022010|NCT02724501|Behavioral|questionnaire|Using questionnaire to obtain patient's medical and family history of cancer.
16022011|NCT02724501|Procedure|Blood sample-DNA testing / Tumour-genetic markers|Using Samples obtained to produce summary statistics on the tumour markers
16022012|NCT02724475|Procedure|LA|Ultrasound-guided puncture to the front of the thrombus with a power of 30 watts and pulse time of 0.3-0.4 seconds with 1 second interval until the thrombus was totally eliminated
16022013|NCT02724475|Procedure|3D-CRT|γ-knife treatment with radiation dose of 48-63 Gy/6-9 times
16022014|NCT02724462|Behavioral|Smartphone-delivered Intervention (SmartQuit)|The experimental arm includes an intervention using a novel smartphone smoking cessation app.
16022015|NCT02724462|Behavioral|: Smartphone-delivered Intervention (Standard of care app)|The control intervention uses a standard of care smartphone smoking cessation app.
16022016|NCT02724449|Device|Cavilon Advanced Barrier Film|Cavilon Advanced Barrier Fim's application applied twice a week
16022017|NCT02724436|Procedure|TACE|
16022018|NCT02724436|Procedure|radioembolization with Y-90|radioembolization with Y-90
16022019|NCT02724423|Drug|NRL-1|
16022020|NCT02724410|Drug|home intravenous ertapenem|see arm description
16022021|NCT02724410|Drug|home oral amoxicillin-clavulanate|see arm description
16022022|NCT02724410|Device|peripheral inserted central Catheter|All patients undergoing home intravenous ertapenem will require placement of peripheral inserted central Catheter (PICC) for home delivery of antibiotics.
16022023|NCT02724397|Device|LCI/BLI then white endoscopy|First use of Linked Color Imaging/Magnifying Blue Laser Imaging (LCI/BLI) and then White Light Endoscopy to detect colonic adenomas.
16022024|NCT02724397|Device|White endoscopy and then LCI/BLI|First use of White Light Endoscopy and then Linked Color Imaging/Magnifying Blue Laser Imaging (LCI/BLI) to detect colonic adenomas.
16022025|NCT02724384|Device|MOE Plasma Delivery System A|Plasma treatment
16022026|NCT02724384|Device|MOE Plasma Delivery System B|Plasma treatment
16022027|NCT02724371|Device|Mentor Larger Size MemoryGel Ultra High Profile Breast Implant|The Mentor smooth and Siltex® larger size MemoryGel® Ultra High Profile (UHP-L) breast implants are large round silicone gel-filled breast implants. The devices are made with cross linked layers of silicone to provide the prosthesis with elasticity and integrity.
16022028|NCT02724358|Procedure|TACE|iodized oil (5ml) + Pirarubicin (20mg)
16022029|NCT02724358|Drug|Rg3|20mg, BID, maintained though Month 12.
16022030|NCT02724358|Other|TACE + Rg3|
16022031|NCT02724358|Procedure|protective therapy|standard liver protective therapy
16022032|NCT02724332|Drug|Rapamycin|2mg,po,bid
16022033|NCT02724319|Device|SpartanRX|A buccal swap genetic sample will be collected from eligible patients who provide written informed consent for CYP2C19 testing. Genotyping will be performed by the SpartanRX system as a clinical test at the UF Health Pathology Laboratory in Jacksonville.
16022034|NCT02724306|Behavioral|Active Lifestyle Programme|
16022035|NCT02724293|Drug|pregabaline 300 mg once.|patients received pregabaline 300 mg 2 hours pre-operatively.
16022036|NCT02724293|Drug|pregabaline 300 mg twice.|patients received pregabaline 300 mg 2 hours pre-operatively, and 12 hours later.
16022037|NCT02724293|Drug|pregabaline 600 mg once.|patients received pregabaline 600 mg 2 hours pre-operatively.
16022038|NCT02724293|Drug|placebo|patients received placebo
16022039|NCT02724280|Device|WLE and then LCI|The gastric mucosa was evaluated with WLE and then LCI by two different endoscopists.
16022040|NCT02724280|Device|LCI and then WLE|The gastric mucosa was evaluated with LCI and then WLE by two different endoscopists.
16022041|NCT02724267|Biological|131I-chTNT-1/B|29.6 MBq/kg,intravenous administration in 1 hour，1-3 course of treatment
16022042|NCT02724254|Drug|AP611074 5% gel|
16022043|NCT02724254|Drug|AP611074 matching placebo|
16022044|NCT02724241|Other|one time exposure to e-cig with nicotine|one time exposure to e-cigarette vapor with nicotine
16022045|NCT02724241|Other|One time exposure to e-cigarette without nicotine|One time exposure to e-cig without nicotine
16022046|NCT02724241|Other|one time exposure to empty e-cigarette|one time exposure to empty e-cigarette (sham control)
16022047|NCT02724228|Drug|BMN 111|BMN 111 will be administered subcutaneously daily.
16022048|NCT02724215|Device|Sleep Apnea Screening (Out of Center Polysomnography Device)|
16022049|NCT02724202|Drug|Curcumin|Curcumin is supplied as soft-gel capsule. It is a micronized rhizome extract containing phospholipids and 500mg of pure curcuminoids (95% curcumin, 5% desmethoxycurcumin) suspended in turmeric essential oil.
16022050|NCT02724202|Drug|5-flurorouracil|Fluorouracil is an anti-cancer (antineoplastic or cytotoxic) chemotherapy drug. Fluorouracil is classified as an antimetabolite.
16022051|NCT02724189|Device|MyPreOp assessment|MyPreOp is an online preoperative assessment programme created by a medical software company called Ultramed.
16022052|NCT02724189|Other|Nurse led assessment|Standard practise is where patients undergo a face to face preoperative assessment led by a qualified nurse specialising in this field.
16022053|NCT02724176|Drug|carbon nanoparticles|0.1 ml of CN suspension was injected per spot into the tissue surrounding the tumor using a skin test syringe. Two or three randomly selected spots were injected slowly for each tumor, and the total amount injected was no more than 0.5 mL per lobe.
16022054|NCT02724163|Drug|Gemtuzumab ozogamicin|Antibody-conjugated chemotherapy agent.
16022055|NCT02724163|Drug|Liposomal daunorubicin|"Anthracycline
~(Randomisation 1 (R1)) closed early to recruitment on 8th September 2017, due to liposomal daunorubicin manufacturing issues resulting in unavailability of the drug."
16022056|NCT02724163|Drug|Mitoxantrone|DNA-reactive agent
16022057|NCT02724163|Drug|Fludarabine|A water-soluble fluorinated nucleotide analogue of the antiviral agent vidarabine.
16022058|NCT02724163|Drug|Cytarabine|Pyrimidine nucleoside analogue, an antineoplastic agent.
16022059|NCT02724163|Drug|Busulfan|Alkylsulfonate
16022060|NCT02724163|Drug|Cyclophosphamide|A nitrogen mustard alkylating agent from the oxazaphosphorine group
16022061|NCT02724150|Drug|Omeprazole High dose|High regimen of Proton Pump Inhibitors in treatment of bleeding ulcer 80 mg loading dose then 8 mg/h iv for 3 days
16022062|NCT02724150|Drug|Omeprazole Low dose|low regimen of Proton Pump Inhibitors in treatment bleeding ulcer 80 mg loading dose then 40 mg two times per day for 3 days
16022063|NCT02724137|Behavioral|Fitbit®|Participants can read how many steps/day they walked on the Fitbit® daily. The treating physical therapist reviews Fitbit® recorded steps from the previous week and together with the patient sets a new step goal. The physical therapist discusses barriers to meeting step goals are discussed. Self-reward for meeting step/goal is set weekly. Participants in this group will also receive 1-month phone calls for 6-months after completing physical therapy rehabilitation to discuss physical activity, set monthly step count goal, barriers to overcoming goal and to continue to develop a reward system for when the participant achieves their step count goal.
16022119|NCT02723903|Drug|Prozac|we use Prozac for the patient with depression
16098986|NCT02171039|Drug|Dabigatran|
16022064|NCT02724137|Other|Physical Therapy Rehab|Standard of care physical therapy after total knee replacement. The goals of physical therapy are to increase knee range of motion and strength, improve balance and agility, and increase daily walking. Physical therapy appointment times range from 45-60 minutes with appointments occurring 2 times a week for 6-8 weeks.
16022065|NCT02724124|Other|Static Stretching|3 sets of 30-second self static hamstring stretch (IT), quadriceps (QD) and sural triceps (TS) of both lower limbs, with an interval of 30 seconds of rest between sets
16022066|NCT02724124|Other|warm up|Warm-up for 10 minutes at 70-80% of maximum heart rate.
16022067|NCT02724124|Other|static stretching + warm up|3 sets of 30-second self static hamstring stretch (IT), quadriceps (QD) and sural triceps (TS) of both lower limbs, with an interval of 30 seconds of rest between sets + Warm-up for 10 minutes at 70-80% of maximum heart rate.
16022068|NCT02724124|Other|warm up+static stretching|Warm-up for 10 minutes at 70-80% of maximum heart rate + 3 sets of 30-second self static hamstring stretch (IT), quadriceps (QD) and sural triceps (TS) of both lower limbs, with an interval of 30 seconds of rest between sets
16022069|NCT02724124|Other|Control|No intervention
16022070|NCT02724111|Drug|sufficient dose of rocuronium|
16022071|NCT02724111|Drug|sugammadex 10 min after position change|
16022072|NCT02724098|Drug|Dexmedetomidine|
16022073|NCT02724085|Drug|TP-271|TP-271 is a novel, broad-spectrum tetracycline with potent activity against multidrug-resistant pathogens. It will be administered intravenously (IV) in doses ranging from 0.15 to 5.0 mg/kg
16022074|NCT02724072|Device|Thoraflex™ Hybrid Device|Single-use medical device sterilized by ethylene oxide which is pre-loaded into a delivery system. The device comprises a gelatin sealed vascular graft combined with a stented graft.
16022075|NCT02724059|Procedure|EBUS with elastography followed by TBNA|Endo bronchial ultrasound (EBUS) with elastography followed by TBNA from mediastinal lesions or lymph nodes
16022076|NCT02724046|Drug|Ciprofloxacin|Single-dose oral ciprofloxacin
16022077|NCT02724033|Procedure|regional nerve block|regional nerve block
16022078|NCT02724033|Drug|Antiemetic|Antiemetic
16022079|NCT02724020|Drug|Everolimus|Everolimus capsules.
16022080|NCT02724020|Drug|MLN0128|MLN0128 capsules.
16022081|NCT02724020|Drug|MLN1117|MLN1117 capsules.
16022082|NCT02723994|Drug|Ruxolitinib|In Part 1, ruxolitinib will be administered at a protocol-defined starting dose in combination with chemotherapy, with dose escalation and de-escalation following the rolling 6 study design. The established recommended starting dose will be taken forward into Part 2.
16022083|NCT02723994|Drug|Asparaginase Erwinia Chrysanthemi|
16022084|NCT02723994|Drug|Cyclophosphamide|
16022085|NCT02723994|Drug|Cytarabine|
16022086|NCT02723994|Drug|Dexamethasone|
16022087|NCT02723994|Drug|Doxorubicin|
16022088|NCT02723994|Drug|Leucovorin Calcium|
16022089|NCT02723994|Drug|Mercaptopurine|
16022090|NCT02723994|Drug|Methotrexate|
16022091|NCT02723994|Drug|Pegaspargase|
16022092|NCT02723994|Drug|Prednisone|
16022093|NCT02723994|Drug|Thioguanine|
16022094|NCT02723994|Drug|Vincristine Sulfate|
16022095|NCT02723981|Device|COMBO-Stent|The OrbusNeich COMBO Bio-engineered Sirolimus Eluting Stent (COMBO Stent) consists of a 316L stainless steel alloy abluminally coated with a biocompatible, biodegradable poly-mer containing sirolimus. Covalently attached to the surface of the stent is a layer of murine, monoclonal, anti-human CD34 antibody. The antibody specifically targets circulatory CD34+ cells (endothelial progenitor cells) thus favoring endothelialization.
16022096|NCT02723981|Drug|Clopidogrel, Vitamin K Antagonist, Rivaroxaban, Dabigatran|Anticoagulant medication after stent Implantation: (N)OAC and clopidogrel for 3 months followed by (N)OAC
16022097|NCT02723981|Device|Any drug eluting stent oder bare metal sent|Implantation of traditional bare metal stents and/or drug eluting stents (any device approved on the market, implanted according to CE marking and IFU) and medication regimen in accordance with ESC Guidelines
16022098|NCT02723981|Drug|ASA, Clopidogrel, Vitamin K Antagonist, Rivaroxaban, Dabigatran|A combination of antiplatelet and anticoagulant therapy according to ESC guidelines (2014)
16022099|NCT02723968|Other|glucose solution at a dose of 1.75 g/kg (up to a maximum of 75 g) for the OGTT and glucose solution at a dose of 0.5 g/kg (up to a maximum of 35 g) was injected in 2.5-3 min for the IGTT|At the first visit at day 1an OGTT will be performed then the CGMS is implanted. Capillary glycaemia will be taken four times a day to set up the CGMS. A second visit is scheduled at day 4, where the intravenous glucose tolerance test is performed as well as the HbA1C level.
16022100|NCT02723968|Procedure|HGPIV diagnosis test|
16022101|NCT02723968|Procedure|HOMAR-IR diagnosis test|
16022102|NCT02723955|Drug|feladilimab (GSK3359609)|
16022103|NCT02723955|Drug|GSK3174998|
16022104|NCT02723955|Drug|Pembrolizumab|
16022105|NCT02723955|Drug|Docetaxel|
16022106|NCT02723955|Drug|Pemetrexed|
16022107|NCT02723955|Drug|Paclitaxel plus Carboplatin|
16022108|NCT02723955|Drug|Gemcitabine plus Carboplatin|
16022109|NCT02723955|Drug|Fluorouracil (5-FU) plus carboplatin or cisplatin|
16022110|NCT02723955|Drug|Dostarlimab|
16022111|NCT02723955|Drug|Cobolimab|
16022112|NCT02723955|Drug|Bintrafusp alfa|
16022113|NCT02723942|Biological|CAR-T cell immunotherapy|This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at GPC3 antigen.
16022114|NCT02723929|Device|active low-intensity transcranial electrical stimulation/active transcranial ultrasound|"Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation of up to 2mA. During active stimulation, the current will be active for the full 20 minutes.
~Subjects will also undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for the full 20 minutes."
16022115|NCT02723929|Device|Sham low-intensity transcranial electrical stimulation/sham transcranial ultrasound|"Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation, as in the active condition; however, during sham stimulation (placebo) the current will not be active for the full 20 minutes.
~Subjects will also undergo 20 minutes of transcranial ultrasound in the same par. During active stimulation, the ultrasound will be active for 20 minutes - however, during sham stimulation (placebo) the ultrasound will not be active for the full 20 minutes."
16098987|NCT02171039|Drug|Atorvastatin|
16022120|NCT02723903|Procedure|coronary artery disease treatment|including medication, coronary artery stent implantation according to the severity of stenosis of the coronary arteries
16022121|NCT02723890|Device|Tyto Device|
16022122|NCT02723877|Drug|PQR309|Dual phosphatidylinositol 3-kinase phosphoinositide 3-kinase/ mammalian target of rapamycin Inhibitor (= PI3K/mTOR Inhibitor)
16022123|NCT02723877|Drug|Eribulin|non.taxane microtubule dynamics inhibitor
16022124|NCT02723864|Drug|Veliparib + VX-970 + Cisplatin|ATR protein kinase is central to the DNA damage response and homologous recombination, activating a series of phosphorylation cascades, culminating in cell cycle arrest to allow time for DNA repair. PARP plays a pivotal role in base-excision repair of single strand breaks formed either due to direct genotoxic stress or during the processing of double strand breaks. Preclinical studies show ATR inhibitor VX-970 synergizes with cisplatin to induce DNA damage and antitumor activity. The addition of PARP inhibitor veliparib with VX-970 allows for impairment of DNA repair, induction of a BRCA null phenotype, and potentiation of the antitumor activity of cisplatin.
16022125|NCT02723851|Device|Corsens|Recording and calculating Peak Endocardial Acceleration (PEA) Myocardial Contractility Index [MCI] and isovolumetric contraction (IVCT). Measurements will not affect the treatment provided to the patients.
16022126|NCT02723838|Biological|REOLYSIN®|3 cycles (each cycle = 21 days). Cohort 1: 3x10E10 TCID50 intratumoral via cystoscopy on Day 1 of each cycle. Cohort 2: 3x10E10 TCID50 intratumoral via cystoscopy on Day 2 of each cycle.
16022127|NCT02723838|Drug|Gemcitabine|3 cycles (each cycle = 21 days). Cohort 1: 1000mg/m2 intravenously on Day 2 and Day 9 of Cycle 2 and Cycle 3. Cohort 2: 1000mg/m2 intravenously on Day 1 and Day 8 of each cycle.
16022128|NCT02723838|Drug|Cisplatin|3 cycles (each cycle = 21 days). Cohort 1: 70 mg/m2 intravenously on Day 2 of Cycle 2 and Cycle 3. Cohort 2: 70 mg/m2 intravenously on Day 1 of each cycle.
16022129|NCT02723825|Procedure|Closed reduction|Treated with Manipulatio, using plywood, gypsum or external fixation support to fixed
16022130|NCT02723825|Procedure|Open reduction|Open reduction and internal fixation
16022131|NCT02723812|Biological|GCFLU® Influenza vaccine (Split virion, Inactivated)|
16022132|NCT02723799|Behavioral|Hope Promotion Program (HPP)|"HPP is based on literature review and qualitative research in hope at the end-of-life. The film Hopeful living reflects the findings of the grounded theory study. Hope activity book is the final product of the literature review on hope interventions and its activities were tested in their feasibility and suitability in our previous research with persons with advanced cancer and their families."
16022133|NCT02723799|Other|Standard Treatment Protocol|Regular assessment and care by the hospital outpatient health care team.
16022134|NCT02723786|Biological|GSK1070806|Injectable solution of 100 milligram/millilitre (mg/mL), administered as a single dose of 3 milligram/kilogram (mg/kg) (maximum of 10 mg/kg) diluted in 100 mL sterile IV infusion bag of 0.9% Sodium Chloride.
16022135|NCT02723786|Drug|1) basiliximab 2) mycophenolate mofetil (MMF) OR azathioprine 3) tacrolimus 4) corticosteroids|This immunosuppressant regimen may be revised based on the clinical judgment of the investigator including titration of tacrolimus levels.
16022136|NCT02723773|Biological|Herpes Zoster Vaccine GSK1437173A|Intramuscular injection
16022137|NCT02723760|Drug|99mTc-3PRGD2|"SPECT/CT scanning: single intravenous bolus injection of nearly 11.1 MBq/kg body weight of 99mTc-3PRGD2 on rheumatoid arthritis patients, whole-body planar and lesions section for determination the accumulation of 99mTc-3PRGD2 in the joints and other parts of the body.
~For diagnosis study, each patient will be carried out SPECT/CT scanning once. For efficacy evaluation study, each patient will be carried out SPECT/CT scanning three times (before treatment, the midterm treatment and late stage treatment)."
16022138|NCT02723747|Other|myocardial perfusion with magnetic resonance imaging|
16022139|NCT02723734|Other|Decipher® Testing|Decipher® Prostate Cancer Classifier (Post-Op and Biopsy), a Genomic Classifier (GC) test. Biopsy and prostatectomy specimens will be collected for GC testing.
16022140|NCT02723721|Drug|Picato gel|apply on and 1 cm around the lesion, 0.47 g of Picato® gel 150 µg/g, once a day on 3 consecutive days.
16022141|NCT02723708|Other|Real-Time functional Magnetic Resonance Imaging Feedback (RTFF)|During the Activate trials, the thermometer will display the weighted average of VTA BOLD activation, dynamically updated every second. This continuously updated thermometer is the primary feedback mechanism.
16022142|NCT02723695|Other|Evaluation of postural performances|Postural tests
16022143|NCT02723682|Other|Collect 24-hour urine specimen|A random half sample of NHANES participants 20-69 examined in the mobile examination center were asked to collect a 24-hour urine specimen.
16022144|NCT02723669|Drug|AR10|effervescent tablet
16022145|NCT02723669|Drug|acetylcysteine|oral solution
16022146|NCT02723656|Behavioral|Online Referral NYS Quitline|Care coordinator will make an online referral to the NYS Quitline.
16022147|NCT02723656|Behavioral|Tobacco cessation counseling and coordination of cessation medications|Care coordinator will obtain verbal consent to transfer the patient to the NYS Quitline via 3-way call (warm transfer). The care coordinator will also assist the patient in obtaining NRT from a regular care provider, then call the patient every three months for 12 months to assess current smoking and offer to help smokers obtain additional cessation counseling and medications.
16022148|NCT02723630|Drug|Lenvatinib 10 mg|"Treatment 1: low Type-C crystal level <12%
~Treatment 2: reference* Type-C crystal level 12% to 26%
~Treatment 3: high Type-C crystal level >26%"
16022149|NCT02723617|Other|MED 0.5|Participants will be fed a Mediterranean diet providing 0.5 oz. per day of lean beef.
16022150|NCT02723617|Other|MED 2.5|Participants will be fed a Mediterranean diet providing 2.5 oz. per day of lean beef.
16022151|NCT02723617|Other|MED 5.5|Participants will be fed a Mediterranean diet providing 5.5 oz. per day of lean beef.
16022152|NCT02723617|Other|AAD 2.5|Participants will be fed an average American diet providing 2.5 oz. per day of lean beef.
16022181|NCT02723357|Behavioral|Financial Coaching|Enrollment in one-to-one financial coaching intervention to support savings, income, and credit while reducing debt using available tools in the community development field.
16022182|NCT02723357|Behavioral|Access to Social Service Referrals|Access to referrals for common social needs.
16022217|NCT02723110|Other|4 Hour Frequently Sampled Oral Glucose Tolerance Test|Blood glucose level(BGL) every 5 min, blood for hormone, biochemical analysis at -15,0,15,30,45,60,90,120,180, 240
16100570|NCT02159352|Drug|Darunavir|
16022153|NCT02723604|Device|Low Level Laser Therapy|Patients will receive LLLT three times per week concurrently with chemoradiotherapy. LLLT may be delivered either immediately prior to or after the patient's daily fraction of radiotherapy. Patients will be treated extra-orally with a THOR® LED cluster for one minute along the buccal mucosa on each side and intraorally for one minute to the tongue and soft palate. During each LLLT treatment session a thorough oral exam will be performed to identify any areas of mucositis. If the patient should develop intraoral lesions they will be targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings to be used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J.
16022154|NCT02723591|Drug|Tacrolimus|Oral Capsule
16022155|NCT02723591|Drug|Tacrolimus immediate release|Oral Capsule
16022156|NCT02723578|Drug|Pemetrexed|Pemetrexed 500 mg/m2 IV over 10 minutes on day 1 every 21 days
16022157|NCT02723578|Drug|Erlotinib|Erlotinib 150 mg PO once daily on days 1-21 every 21 days
16022158|NCT02723552|Behavioral|Aerobic Exercise|40 minute aerobic exercise sessions 3x/week.
16022159|NCT02723539|Drug|MBN-101|Topical application
16022160|NCT02723539|Drug|Placebo|Topical application
16022161|NCT02723526|Other|Blood drawing|
16022162|NCT02723513|Other|Hyperpolarized Xenon-129|"Hyperpolarized Xenon-129. Noble gas magnetic resonance imaging (MRI) has recently emerged as another research approach for the non-invasive measurement of lung structure and function, including conduction of gas through airways and into airspaces.
~Noble gas MRI provides a complimentary and alternative method for evaluating lung disease and may be superior to CT because it allows simultaneous visualization of both airway and airspace structure and function."
16022163|NCT02723500|Device|Hyperpolarized Xenon MRI|Hyperpolarized noble gas imaging using Xenon-129 has been used to explore structural and functional relationships in the lung in patients with lung disease and healthy controls. In contrast to proton-based MRI imaging, 129Xe gas is used as a contrast agent to directly visualize the airways, and thus ventilation. Whereas the normal density of gas is too low to produce an easily detectable signal, this is overcome by artificially increasing the amount of polarization per unit volume using optical pumping.
16022164|NCT02723487|Drug|Bupivacaine 0.125%|Patients will receive bilateral Transversus Abdominis Plane Block guided by ultrasound device using bupivacaine (Marcaine, 0.125%), 0.5 ml/kg on each side.
16022165|NCT02723487|Drug|Bupivacaine 0.25%|Patients will receive bilateral Transversus Abdominis Plane Block guided by ultrasound device using bupivacaine (Marcaine, 0.25%), 0.5 ml/kg on each side.
16022166|NCT02723474|Device|MRI at baseline and over time|Hyperpolarized noble gas MRI has been used to explore structural and functional relationships in the lung in patients with lung disease and healthy controls. In contrast to proton-based MRI, Helium-3 and Xenon-129 gas is used as a contrast agent to directly visualize ventilation. Whereas the normal density of gas is too low to produce an easily detectable signal, this is overcome by artificially increasing the amount of polarization per unit volume using optical pumping.
16022167|NCT02723461|Drug|Pulsatile Oxytocin|Using a programmable syringe pump, oxytocin will be administered for 10 seconds every 6 minutes and the dose (2 mU/pulse) doubled every 30 minutes until uterine contractions will be established (3-4 in 10 minutes).
16022168|NCT02723461|Drug|Continuous Oxytocin|Oxytocin will be administered at starting dose (2 mU/min) in a continuous manner doubled every 30 minutes until uterine contractions will be established (3-4 in 10 minutes).
16022169|NCT02723448|Drug|aclarubicin|Aclarubicin (3 mg/m²) will be administered intravenously through a central venous access device over 1 hour for four consecutive days per 28 day cycle. There is no maximum number of cycles.
16022170|NCT02723435|Drug|Midostaurin|Given PO
16022171|NCT02723422|Procedure|Prehabilitation visit/increased physical therapy post-TAVR|Prior to TAVR, patients randomized to the intervention arm will meet with a licensed physical therapist for a 30-minute session in the ambulatory setting. Following TAVR, patients randomized to the intervention arm will receive 4 days per week of home-based physical therapy by a licensed physical therapist working for Revival Home Health Care
16022172|NCT02723422|Procedure|Standard of Care Arm|Patients randomized to the usual care arm will receive home-based physical therapy for 2 days per week by Revival Home Health Care, which is the current standard of care.
16022173|NCT02723409|Procedure|Round Procedure Umbilicoplasty|"Umbilicoplasty surgery (belly button reshaping) is performed using the Round Procedure"
16022174|NCT02723409|Procedure|"Scarless round procedure"|"Umbilicoplasty surgery (belly button reshaping) is performed using the Scarless round procedure"
16022175|NCT02723409|Procedure|"Inverted U Procedure"|"Umbilicoplasty surgery (belly button reshaping) is performed using the Inverted U Procedure"
16022176|NCT02723409|Procedure|"Inverted VProcedure"|"Umbilicoplasty surgery (belly button reshaping) is performed using the Inverted V Procedure"
16022177|NCT02723409|Procedure|"Y deepithelialized Procedure"|"Umbilicoplasty surgery (belly button reshaping) is performed using the Y deepithelialized procedure"
16022178|NCT02723383|Drug|BACLOFEN|Daily doses will be adapted to daily MDRD creatinine clearance from 150 to 50mg. On the day of randomisation, the patient will receive the full daily dose in a one-shot administration. Then daily doses will be divided into 3 intakes on the following days. During the mechanical ventilation period, the treatment will be administered via the nasogastric feeding tube. After extubation, the treatment will be administered either via the nasogastric tube or the oral route.
16022179|NCT02723383|Drug|PLACEBO|Daily doses will be adapted to daily MDRD creatinine clearance from 150 to 50mg. On the day of randomisation, the patient will receive the full daily dose in a one-shot administration. Then daily doses will be divided into 3 intakes on the following days. During the mechanical ventilation period, the placebo will be administered via the nasogastric feeding tube. After extubation, the placebo will be administered either via the nasogastric tube or the oral route.
16022180|NCT02723370|Behavioral|Staff multi-component implementation strategy|Staff will receive a multi-component implementation strategy for evidence based practices (EBPs) for colonoscopy, including split-dosing of bowel preparation, low literacy education materials for patients, and teach-back procedure. The implementation strategy includes a supply of low-literacy patient education materials for split-dosing the medication of their choice, poster and pocket-card with teach-back prompts, consultation to integrate materials and teach-back into workflow and a website with additional training and patient materials.
16022317|NCT02722434|Other|Laboratory Biomarker Analysis|Correlative studies
16100571|NCT02159352|Drug|Ritonavir|
16022183|NCT02723344|Dietary Supplement|of Lactobacillus reuteri (L. reuteri; DSM 17938)|Commercially available L. reuteri (deposited in the Deutsche Sammlung von Mikroorganismen und Zellkulturen (DSMZ) and referenced as DSM 17938; Gerber Soothe Colic Drops, 100 million CFU/5 drops; formerly known as L. reuteri ATCC 55730) will be used in the proposed study. L. reuteri (phylum Firmicutes) is a gram-positive anaerobic commensal bacteria found in the gut microbiome of humans. Independent testing of the viability of the commercial product will be conducted in our laboratories by diluting drops, plating on agar in triplicate, and anaerobic culturing at 37 oC. The commercial strain (DSM 17938) has been used to improve intestinal functions in infants and reduce symptoms of infantile colic.
16022184|NCT02723344|Other|Sunflower and medium chain triglyceride oils|Placebo
16022185|NCT02723331|Drug|Nab-paclitaxel and gemcitabine for R-PDAC Patients|Nab-paclitaxel and gemcitabine, for R-PDAC patients, will be given in combination as neoadjuvant and adjuvant chemotherapy. Nab-paclitaxel will be administered by IV infusion at a dose of 125 mg/m2 over 30 minutes on Days 1, 8, and 15 of every 28-day cycle. Gemcitabine will be administered by IV infusion, immediately after the administration of nab-paclitaxel, at a dose of 1000 mg/m2 over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.
16022186|NCT02723331|Drug|Nab-paclitaxel and gemcitabine for BR-PDAC Patients|Nab-paclitaxel and gemcitabine, for BR-PDAC patients, will be given in combination as neoadjuvant and adjuvant chemotherapy. Nab-paclitaxel will be administered by IV infusion at a dose of 125 mg/m2 over 30 minutes on Days 1, 8, and 15 of every 28-day cycle. Gemcitabine will be administered by IV infusion, immediately after the administration of nab-paclitaxel, at a dose of 1000 mg/m2 over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.
16022187|NCT02723318|Behavioral|Financial Coaching|One-to-one financial coaching intervention to support savings, income, and credit while reducing debt using available tools in the community development field.
16022188|NCT02723318|Behavioral|Access to Referrals to Social Services|
16022189|NCT02723305|Other|No intervention|
16022190|NCT02723292|Behavioral|TOP|
16022191|NCT02723292|Behavioral|Control intervention|
16022192|NCT02723279|Behavioral|EPNS|Electrical pudendal nerve stimulation Four sacral points are selected. The two upper points are located about 1 cm bilateral to the sacrococcygeal joint. On the upper points, a needle of 0.40 Х 100 mm is inserted perpendicularly to a depth of 80 to 90 mm to produce a sensation referred to the urethra or the anus. The locations of the two lower points are about 1 cm bilateral to the tip of the coccyx. On the lower points, a needle of 0.40 Х 100 or 125 mm is inserted obliquely towards the ischiorectal fossa to a depth of 90 to 110 mm to produce a sensation referred to the urethra. After the sensation referred to the above regions is produced, each of two pairs of electrodes from a G6805-2 Multi-Purpose Health Device is connected with the two ipsilaterally inserted needles.
16022193|NCT02723279|Drug|TT|Tolterodine tartrate (GSK， UK) 4mg per day is taken orally for six weeks
16022194|NCT02723266|Behavioral|STOPPING-GDM|Educational counseling and skills building Intervention
16022195|NCT02723253|Radiation|Radiotherapy|Radiotherapy was applied as conformal 3-D technique and was delivered with photon energies of 10 - 15 MV. The beams were delivered by an Elekta Precise Linac equipped with standard multi leaf collimators (MLC). A daily online check of isocenter position was performed using portal imaging, with set-up correction in case of displacement > 0.5 cm in any direction. Radiation dose delivered to PTV2 was 45 Gy (1.8 Gy/fraction) with a concomitant boost dose to the PTV1 of 10 Gy with accelerated fractionation at 2.2 Gy/fraction, five consecutive days for week.
16022196|NCT02723253|Drug|Tom-OX|The concurrent chemotherapy consisted of 15 min intravenous infusion Raltitrexed (Tomudex ®) 3 mg/m2 and a two-hours intravenous infusion of Oxaliplatin (Eloxatin ®) at 130 mg/m 2, 20 min after raltitrexed, on days 1, 17, 35.
16022197|NCT02723240|Drug|NUC-3373|
16022198|NCT02723227|Behavioral|Financial Coaching|Enrollment in one-to-one financial coaching intervention to support savings, income, and credit while reducing debt using available tools in the community development field.
16022199|NCT02723227|Behavioral|Referral to Social Services|
16022200|NCT02723214|Procedure|Brain biopsy|Brain biopsy using either the frame-based stereotactic technique, or a frameless fiducial-less brain biopsy method using an optical based navigation system and a mini frame apparatus - trajectory guide.
16022201|NCT02723201|Drug|TAK-020 Captisol Oral Solution|TAK-020 solution.
16022202|NCT02723201|Drug|TAK-020 CCT|TAK-020 co-crystal tablet
16022203|NCT02723201|Drug|TAK-020 SDT|TAK-020 Solid dispersion tablet.
16022204|NCT02723201|Drug|TAK-020 IRT|TAK-020 immediate release tablet.
16022205|NCT02723201|Drug|TAK-020 CCT|TAK-020 co-crystal tablet.
16022206|NCT02723201|Drug|TAK-020 Solid Formulation|TAK-020 solid formulation
16022207|NCT02723188|Device|Sham stimulation (1.5 milliampere,30 seconds)|
16022208|NCT02723188|Device|DC stimulation (1.5 milliampere, 20 minutes)|
16022209|NCT02723188|Device|AC stimulation (1.5 milliampere,1.5 Hertz frequency)|
16022210|NCT02723175|Device|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation is a minimally invasive technique that uses a small amount of electricity (2mA) to temporarily stimulate specific brain areas in awake people.
16022211|NCT02723162|Drug|Varenicline (VRN)|VRN will be provided at the standard recommended dose (0.5 mg daily for 3 days, then 0.5 mg twice daily for 4 days, then 1 mg twice daily thereafter for the remaining 21 days of active treatment.
16022212|NCT02723162|Drug|N-Acetylcysteine (NAC)|NAC will be dosed at 1200 mg twice daily throughout the 28-day active treatment
16022213|NCT02723162|Drug|Placebo|Matched placebo
16022214|NCT02723149|Behavioral|Marijuana Approach Avoidance Training|Approach Avoidance Training (AAT) is a novel computerized procedure that modifies implicit approach tendencies by training individuals to selectively avoid drug- related stimuli, thereby overriding habitual approach tendencies. Participants are randomized to either the treatment or sham condition. Treatment duration involves 6 training sessions of approximately 15 minutes each (400 trials). AAT requires minimal training and involves only a computer and a joystick, in which participants are either pulling or pushing the joystick when different marijuana or non-marijuana images are displayed with either yellow (pull) or blue (push) border.
16022215|NCT02723136|Device|Smartphone Application|Smartphone application developed by internists and engineers. Will be made available on iOS(R) and Android(R) operating systems.
16022216|NCT02723123|Other|Recording of cardio-respiratory signals|Biological signals: ECG, RIP, SpO2 and Pulse rate will be recorded during the interventions and analyzed offline.
16022218|NCT02723110|Other|Isoglycaemic Clamp|Glucose infusion over 4 hours to reproduce OGTT glucose curve to allow measurement of incretin effect. BGL every 5 min, blood for hormone, biochemical analysis at -15,0,15,30,45,60,90,120,180, 240
16022219|NCT02723097|Behavioral|3 RP|
16022220|NCT02723084|Drug|ABT-493/ABT-530|Co-formulated tablet
16022221|NCT02723084|Drug|sofosbuvir (SOF)|Tablet
16022222|NCT02723084|Drug|ribavirin (RBV)|Capsule
16022223|NCT02723071|Drug|Ocrelizumab|Participants will receive a total of 8 intravenous (IV) infusions of ocrelizumab given at intervals of 3 weeks, until disease progression or unacceptable toxicity.
16022224|NCT02723058|Behavioral|ICMHM|ICMHM participants receive a collaborative care model adapted to include an engagement interview, attention to co-morbid conditions, and attention to basic needs.
16022225|NCT02723045|Procedure|Open Lichtenstein Hernioplasty|
16022226|NCT02723045|Procedure|Laparoscopic TEP Hernioplasty|
16022227|NCT02723032|Device|OxyFrame|Validation of a miniaturized pulse oximetry sensor for integration into the frame of oxygen delivery glasses.
16022228|NCT02723019|Behavioral|Volunteer Peer Mentor+Behavioral Hlth Nurse|Intervention group participants receive intervention services from a Volunteer Peer Mentor and a Behavioral Health Nurse
16022229|NCT02723006|Drug|TAK-580|TAK-580 tablets
16022230|NCT02723006|Drug|TAK-202|TAK-202 infusion
16022231|NCT02723006|Drug|vedolizumab|vedolizumab infusion
16022232|NCT02723006|Drug|nivolumab|nivolumab infusion
16022233|NCT02723006|Drug|ipilimumab|ipilimumab infusion
16022234|NCT02722993|Dietary Supplement|Probiotics|
16022235|NCT02722993|Dietary Supplement|Placebo|
16022236|NCT02722980|Dietary Supplement|Placebo|The intervention consists of capsules containing placebo.
16022237|NCT02722980|Dietary Supplement|: Probiotic capsules|The intervention consists of capsules containing probiotics.
16022238|NCT02722967|Drug|Aripiprazole + IEM (Ingestible Event Marker)|Oral aripiprazole (2, 5, 10, 15, 20, or 30 mg) with an ingestible event marker in a single daily dose for duration of the trial.
16022239|NCT02722954|Drug|Demcizumab|Drug: Demcizumab at starting dose of 2.5mg/kg administered intravenously (IV).
16022240|NCT02722954|Drug|Pembrolizumab|Drug: Pembrolizumab administered 2mg/kg IV every 3 weeks
16022241|NCT02722941|Drug|Panobinostat|Maintenance therapy dosing as outlined in Cohorts A and B.
16022242|NCT02722928|Other|Controlled Ventilation with 100% oxygen|Patients in group B will be switched from conventional 1:1 oxygen / air ventilation to 100% oxygen controlled ventilation once tumor resection is completed and hemostasis started. They will inhale 100% oxygen until extubation
16022243|NCT02722915|Procedure|fMRI|collection of functional brain data for 1 hour per day
16022244|NCT02722915|Behavioral|Neurofeedback|Task of the participants is to increase or decrease the connectivity between selected brain regions in double-blind, randomized order. After the regulation they will get a feedback about the regulation success. (Patients and controls with AVH: days 3 & 4; controls without AVH: Days 2 & 3)
16022245|NCT02722915|Other|PANAS|to assess the mood before and after the fMRI and after 1 week during a telephone interview
16022246|NCT02722915|Other|AVHRS|to assess the intensity and quality of the hallucinations before and after the fMRI and after 1 week during a telephone interview
16022247|NCT02722915|Other|SF36|questionnaire about life quality after 1 week during a telephone interview
16022248|NCT02722902|Drug|Carnitor|"CARNITOR® (levocarnitine) is a carrier molecule in the transport of long-chain fatty acids L-Carnitine will be administrated intravenously as continuous infusion during the 6-hour hyperinsulinemic euglycemic clamp. The administration will start with a bolus of 15mg/kg for 10 minutes. Subsequently, continuous L-carnitine infusion of 10mg/kg will start for the remaining 350 minutes.
~across the inner mitochondrial membrane."
16022249|NCT02722902|Dietary Supplement|IntraLipid|Lipid emulsion for infusion
16022250|NCT02722902|Dietary Supplement|Placebo|Saline will be used as placebo
16022251|NCT02722876|Other|Contralateral Rehabilitation|Patients will undergo resistance training of the thigh musculature of the non-injured (contralateral) limb 3 times per week. The exercises will consist of unilateral: knee extensions; knee flexions and; leg-press, all performed on commercially-available resistance training machines. To optimise strength gains, patients will work to the 5 repetition-maximum rule (Kraemer et al. 2002); 3 sets of each exercise will be performed and a 2-minute rest will separate each set. Sessions will take no longer than 15-20 minutes, including rest.
16022252|NCT02722876|Other|Placebo flexibility exercise|Patients will perform 'placebo' flexibility training of the upper limb, which will involve a time-matched stretching programme targeting the latissimus dorsi, triceps brachii, biceps brachii, trapezius and pectoral muscles of both limbs. Each stretch will be performed twice, held for 20-30 seconds each time and will be followed by a 30-second rest (McCrary et al. 2015)
16022253|NCT02722850|Behavioral|ALIVE|ALIVE is an email-based platform designed to help participants increase their physical activity, increase fruit and vegetable consumption, and decrease their intake of saturated and trans fats and added sugars. This automated system contains content and tailoring that is delivered in the form of emails obtained directly from cancer patients. Additional information they will receive included: tips for achieving those goals, health information, and opportunities for interaction and engagement.
16022254|NCT02722837|Drug|SOF/VEL|400/100 mg FDC tablet administered orally once daily
16022255|NCT02722824|Device|Electro-stimulation|
16022256|NCT02722824|Other|Placebo|
16022257|NCT02722811|Drug|Etanercept|etanercept of 50 mg/w, subcutaneous injection; treatment: 8 weeks
16022258|NCT02722811|Other|Health education, exercise and diet guidance|Health education, exercise and diet guidance in patient; treatment: 8 weeks
16022259|NCT02722798|Drug|KRN23|Doses may be titrated to achieve the target peak serum phosphorus range
16022285|NCT02722616|Device|Ultrasound scan of the pancreas|A 4D ultrasound scan will be acquired at the time at simulation and used as a reference ultrasound image for localizing tracking target. The ultrasound probe will be placed at the abdominal area to monitor the pancreas motion. The probe will remain in place during the CT scan. Patient setup and the ultrasound probe location will be recorded so that the same setup can be reproduced during treatment delivery.
16022318|NCT02722434|Other|MC5-A Scrambler Therapy|Undergo Scrambler therapy
16022319|NCT02722434|Other|Questionnaire Administration|Ancillary studies
16022260|NCT02722785|Behavioral|Aerobic and Resistance Exercise Training|Supervised aerobic and resistance exercise program consisting of 2 weekly sessions of approximately 60 minutes. Patients will perform a test of maximum cardio-respiratory (Watt-max test) and muscle strength (1 repetition maximum [1-RM] test) capacity. Using the patient's individual capacity score (Watt-max and 1RM), a personalized exercise program will be prescribed. After a light warm-up, patients will perform 20-30 min of aerobic interval training of stationary bicycle. Resistance training comprises 4 exercises for the major muscle groups: chest press, leg press, lateral pull, and knee extension with 3-4 sets of 8 to 15 repetitions. Each session will be supervised by trained instructors to ensure proper technique, and progression in training load.
16022261|NCT02722772|Drug|Etanercept|Intra-articular injection of etanercept of 25mg/w/joint for 5 weeks.
16022262|NCT02722772|Other|Health education, exercise and diet guidance|Health education, exercise and diet guidance in patient; treatment: 5 weeks
16022263|NCT02722759|Other|hemoglobin measurement|
16022264|NCT02722746|Drug|Ropivacaine|Epidural block infusion with Ropivacaine 0.2% will be provided as the anesthesia per standard of care during the procedure.
16022265|NCT02722746|Drug|Epinephrine|Participants will receive epinephrine in their epidural block infusion during the procedure. The amount of epinephrine provided during the procedure will be based on the group assignment.
16022266|NCT02722733|Drug|G-CSF (filgrastim)|
16022267|NCT02722733|Drug|Cytosine arabinoside with G-CSF (filgrastim)|
16022268|NCT02722720|Procedure|Transradial carotid artery stenting|The radial artery is punctured with a trocar. A guidewire is advanced through its lumen, and the trocar is withdrawn. An introducer is passed into the vessel. Then a standard endovascular procedure is carried out under local anesthesia and fluoroscopic control. To prevent cerebral embolism, a protection device is positioned distally of target lesion in internal carotid artery. Then balloon angioplasty of target lesion (if required) is provided. After the angiographic control stent is implanted. After removing all of devices a control angiographic study is provided. Medical therapy includes aspirin(acid acetylsalicylic) 125 - 300 mg/d and plavix (clopidogrel) in dose 300-600 mg prescription before the procedure and heparin sodium injection during the procedure(5000 U iv). After the procedure aspirin(acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and Plavix (clopidogrel) in dose 75/d should be prescribed within 2 months.
16022269|NCT02722720|Procedure|Transfemoral carotid artery stenting|The common femoral artery is punctured with a trocar. A guidewire is advanced through its lumen, and the trocar is withdrawn. An introducer is passed into the vessel. Then a standard endovascular procedure is carried out under local anesthesia and fluoroscopic control. To prevent cerebral embolism, a protection device is positioned distally of target lesion in internal carotid artery. Then balloon angioplasty of target lesion (if required) is provided. After the angiographic control stent is implanted. After removing all of devices a control angiographic study is provided. Medical therapy includes aspirin(acid acetylsalicylic) 125 - 300 mg/d and plavix (clopidogrel) in dose 300-600 mg prescription before the procedure and heparin sodium injection during the procedure(5000 U iv). After the procedure aspirin(acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and Plavix (clopidogrel) in dose 75/d should be prescribed within 2 months.
16022270|NCT02722707|Device|magnetic anal sphincter augmentation for fecal incontinence|Surgical placement of HUD called FENIX for female patients that have failed conservative therapy and less invasive therapies or who are not candidates for such therapies
16022271|NCT02722694|Drug|Subcutaneous(SC) Abatacept|Subjects received 125mg weekly SC abatacept injections for 24 weeks. All subjects who complete 24 weeks double-blind treatment are eligible to enter open label period. During this period, subjects in placebo group will be switched to receive abatacept 125mg administered SC weekly till week 52. Subjects in abatacept group will continue to receive abatacept 125mg weekly.
16022272|NCT02722694|Other|Placebo|Subjects received weekly SC placebo injections for 24 weeks
16022273|NCT02722694|Drug|Methotrexate|All Subjects received backup Methotrexate treatment.
16022274|NCT02722681|Procedure|Blood and urine sampling|Collection of blood and urine samples taken during usual clinical management
16022275|NCT02722681|Procedure|Cerebrospinal fluid sampling|Collection of cerebrospinal fluid samples taken during usual clinical management
16022276|NCT02722668|Drug|Fludarabine|Both Arms: 30 mg/m^2 IV over 1 hour Day -6 to Day -2
16022277|NCT02722668|Drug|Cyclophosphamide|Arm 1: 50 mg/kg IV over 2 hours Day -6
16022278|NCT02722668|Drug|MMF|"Both Arms:
~Mycophenolate mofetil (MMF) 3 gram/day IV/PO for patients who are ≥ 40 kg divided in 2 or 3 doses. In obese patients (>125% IBW) 15 mg/kg every 12 hours may be considered. Pediatric patient (<40 kilograms) will receive MMF at the dose of 15 mg/kg/dose every 8 hours beginning Day -3. MMF dosing will be monitored and altered as clinically appropriate based on institutional guidelines. Patients will be eligible for MMF dosing and pharmacokinetics studies.
~Stop MMF at Day +30 or 7 days after engraftment, whichever day is later, if no acute graft versus host disease (GVHD). (Definition of engraftment is 1st day of 3 consecutive days of absolute neutrophil count [ANC) ≥ 0.5 x 109 /L]). If no donor engraftment, do not stop MMF."
16022279|NCT02722668|Drug|Sirolimus|"Both Arms:
~Adult Dosing: Sirolimus will be administered starting at Day -3 with 8-12 mg oral loading dose followed by single dose 4 mg/day with a target serum concentration of 3 to 12 mg/mL by high-performance liquid chromatography (HPLC) and will be monitored per institutional guidelines. In the absence of acute GVHD sirolimus may be tapered starting at Day +100 and eliminated by Day +180 post-transplantation.
~Pediatric Dosing: Sirolimus will be administered starting on Day -3 with an oral loading dose of 10 mg followed by maintenance dosing of 2.5 mg/m^2/day (Maximum total daily dose of 4mg) as per institutional guidelines. Target serum concentration goals are 3 to 12 mg/mL by high-performance liquid chromatography (HPLC) and will be monitored per institutional guidelines."
16022280|NCT02722668|Radiation|TBI|Both Arms: 200 cGy on Day -1
16022281|NCT02722668|Biological|Umbilical cord blood cell infusion|Both Arms: Day 0
16022282|NCT02722668|Biological|ATG|Arm 2: 15 mg/kg IV every 12 hours Day -6 to Day -4
16022283|NCT02722642|Biological|Bronchial basal cells|Patients will receive 10^6 (1 million) /Kg/person cells of clinical grade bronchial basal cells (BBCs) injected via fiberoptic bronchoscopy after fully lavage of the localized lesions.
16022284|NCT02722629|Procedure|FEESST|Flexible Endoscopic Evaluation of Swallowing with Sensory Testing
16022314|NCT02722473|Biological|"NSE dosage normothermia arm"|There 3 dosage of NSE per patient included: day 1, day 2 and day 3 during targeted temperature management at 37°C.
16022286|NCT02722616|Device|Ultrasound scan of the Liver|A 4D ultrasound scan will be acquired at the time at simulation and used as a reference ultrasound image for localizing tracking target. The ultrasound probe will be placed at the abdominal area to monitor the liver motion. The probe will remain in place during the CT scan. Patient setup and the ultrasound probe location will be recorded so that the same setup could be reproduced during treatment delivery. The ultrasound probe in the CT image will be contoured and radiation beams that directly pass through the ultrasound probe will be avoided.
16022287|NCT02722616|Drug|Reference ultrasound|A reference ultrasound scan will be conducted on each subject during breath-hold. Subjects will be required to lie in supine position and engaged with ABC; an ultrasound probe will be placed at the abdomen area with minimal pressure applied. Continuous motion monitoring is achieved by acquiring 4D ultrasound images using a motorized 3D ultrasound probe to image the pancreas, liver and other intra-abdominal organs continuously. Several 4D ultrasound scans will be collected during subsequent breath-holds that serve as secondary images.
16022288|NCT02722603|Drug|gabapentin|75 mg/ml gabapentin syrup
16022289|NCT02722603|Drug|tramadol|100 mg/ml tramadol oral drops
16022290|NCT02722603|Other|placebo tramadol|placebo tramadol oral drops
16022291|NCT02722603|Other|placebo gabapentin|placebo gabapentin syrup
16022292|NCT02722577|Procedure|Radio-frequency Ablation|A procedure that uses radiofrequency energy to destroy a small area of heart tissue that is causing rapid and irregular heartbeats.
16022293|NCT02722564|Behavioral|self estimation of breath alcohol content|
16022294|NCT02722564|Device|breath alcohol content as measured by Alco Sensor IV device|
16022295|NCT02722564|Other|drink a beer|drink a beer, repeat until breath alcohol content 0.1
16022296|NCT02722551|Device|Transcatheter Mitral Valve Re-placement (TMVR) with the CardiAQ-Edwards™ Transcatheter Mitral Valve|Replacement of the mitral valve through a transcatheter approach
16022297|NCT02722538|Drug|Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200|TAR-200 is a passive, nonresorbable gemcitabine-releasing intravesical drug delivery system, regulated as a drug, whose primary mode of action is the controlled release of gemcitabine into the bladder over a 7-day period.
16022305|NCT02722512|Biological|Heat Shock Protein Peptide Complex-96 (HSPPC-96)|The vaccine is patient specific, created from the patient's own brain tumor resected at a clinically necessary surgery. The vaccine is administered intradermally on a weekly basis.
16022306|NCT02722512|Procedure|Tumor Resection|Clinically-indicated removal of the tumor
16022307|NCT02722512|Radiation|Radiation|Focal Radiation Therapy
16022308|NCT02722499|Behavioral|High Frequency Financial Incentive|"Diabetes Education/Skills Component. Subjects will receive weekly telephone-delivered diabetes/skills training for 12 weeks with home telemonitoring.
~High Frequency Financial Incentive: the high frequency incentive structure will receive a reward for uploading glucose measurements, attending educational sessions, and absolute percentage drops in HbA1c from baseline at 3-month follow-up, up to $300. Each week participants can receive up to $10 for uploading glucose measurements and having good glucose control throughout the week. If they upload measurements every day of the week and their average glucose measurements at the end of the week are 150 or below they will receive an additional $3. Participants can also earn $5 each week if they attend the educational session. After 3 months, if their HbA1c has dropped 2% from baseline, or absolute HbA1c is 7%, they will receive a reward of $130, for a 1% drop, or an absolute HbA1c between 7 and 8 they will receive a reward of $65."
16022309|NCT02722499|Behavioral|Moderate Frequency Financial Incentive|"Diabetes Education/Skills Component. Subjects will receive weekly telephone-delivered diabetes/skills training for 12 weeks with home telemonitoring.
~Moderate Frequency Financial: the moderate frequency incentive structure will receive a reward for uploading glucose measurements, and absolute percentage drops in HbA1c from baseline at 3-month follow-up, up to $300. Each week participants can receive up to $10 for uploading glucose measurements and having good glucose control throughout the week. For each day they upload at least one glucose measurement, they will receive $1 (up to $7 at the end of the week). If they upload measurements every day of the week and their average glucose measurements at the end of the week are 150 or below they will receive an additional $3. After 3 months, if their HbA1c has dropped 2% from baseline, or absolute HbA1c is 7%, they will receive a reward of $170, for a 1% drop, or an absolute HbA1c between 7 and 8 they will receive a reward of $85"
16022310|NCT02722499|Behavioral|Low Frequency Financial Incentive|"Diabetes Education/Skills Component. Subjects will receive weekly telephone-delivered diabetes/skills training for 12 weeks with home telemonitoring.
~Low Frequency Financial Incentive: the low frequency incentive structure will receive a reward for absolute percentage drops in HbA1c from baseline at 3-month follow-up, up to $300. After 3 months, if their HbA1c has dropped 2% from baseline, or absolute HbA1c is 7%, they will receive a reward of $300, for a 1% drop, or an absolute HbA1c between 7 and 8 they will receive a reward of $150."
16022311|NCT02722486|Device|Vestibular Rehabilitation/Balance Belt|With this device, a subject stands on a force platform on the ground, which measures his/her center of pressure. Additionally, there is laptop displaying the video-based exercise programs and a camera that senses the subject's linear sway, roll, and pitch. Information about the subject's position is transmitted via Bluetooth technology to a non-invasive vibrotactile belt which fits comfortably around the subject's waist, over his/her clothing. Using the Sensory Kinetics software, the subject will play a series of games projected on the laptop screen, which prompt him/her to sway in various directions while keeping both feet planted on the force platform.
16022312|NCT02722486|Other|Standard Vestibular Rehabilitation|This is the standard three-month vestibular rehabilitation therapy that patients are routinely referred to at Boston Children's Hospital.
16022313|NCT02722473|Biological|"NSE dosage hypothermia arm"|There 3 dosage of NSE per patient included: day 1, day 2 and day 3 during targeted temperature management between 33° and 37°C.
16022320|NCT02722434|Other|Transcutaneous Electrical Nerve Stimulation|Undergo TENS
16022321|NCT02722421|Drug|Levonorgestrel|Increased dose levonorgestrel implant plus efavirenz-based antiretroviral therapy.
16022322|NCT02722421|Drug|Efavirenz|Participants will receive efavirenz-based ART as part of standard of care
16022323|NCT02722408|Drug|Gemcabene|300 mg tablet orally once daily for four weeks followed by 600 mg tablet orally once daily for four weeks followed by 900 mg tablet orally once daily for four weeks.
16022324|NCT02722382|Other|Patient-Centered Kidney Transitions Care|In a multi-faceted pragmatic approach, the intervention will 1) implement new electronic health information tools to help providers recognize patents in need of Kidney Transitions Care and focus their attention on patients' values and treatment preferences; and 2) implement a Kidney Transitions Specialist who will provide and facilitate integrated delivery of patient support programs that provide patients with knowledge, skills, and assistance to manage their disease, make high-quality treatment decisions, obtain needed psychosocial support, and navigate complex treatment plans.
16022325|NCT02722369|Drug|Gemcitabine|Chemotherapy
16022326|NCT02722369|Drug|Carboplatin|Chemotherapy
16022327|NCT02722369|Drug|Etoposide|Chemotherapy
16022328|NCT02722369|Drug|Hydroxychloroquine|Maintenance Agent
16022329|NCT02722356|Drug|Oxytocin|Oxytocin administered per oxytocin group or standard practice group (see above)
16022330|NCT02722343|Drug|Tenofovir intravaginal ring|The participant will wear the intravaginal ring consecutively for 14 days and nights. Following study product use and at study visit 4, blood and genital tract samples will be taken (to include cervico-vaginal fluid and tissue)
16022331|NCT02722343|Drug|Truvada|The participant will take the tablet for 14 days. taking one tablet each morning. Following study product use and at study visit 4, blood and genital tract samples will be taken (to include cervico-vaginal fluid and tissue)
16022332|NCT02722330|Device|Baha 5 SuperPower on Baha Attract System|The Investigational device involves the following parts: the sound processor unit, an actuator unit and a cable that connects the sound processor and actuator units. The actuator unit is attached to the Sound Processor Magnet (SP Magnet) of the Baha Attract System which is pulled towards the BIM400 Baha Implant Magnet that is fixated to the BI300 Implant. The actuator unit can also be connected to the Baha Softband via a snap coupling.
16022333|NCT02722317|Behavioral|psychological support|psychological support was given to men by the service, the researcher didn't interfered in the intervention, just ask questions about it.
16022334|NCT02722304|Biological|ARALAST NP 60 mg/kg|ARALAST NP is an Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy
16022335|NCT02722304|Biological|ARALAST NP 120 mg/kg|ARALAST NP is an Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy
16022336|NCT02722304|Biological|GLASSIA 60 mg/kg|GLASSIA is an Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy
16022337|NCT02722304|Biological|GLASSIA 120 mg/kg|GLASSIA is an Alpha1-Proteinase Inhibitor (A1PI) augmentation therapy
16022338|NCT02722304|Biological|Human Albumin 2%|Human albumin 2% (by appropriate dilution with normal saline solution)
16022339|NCT02722291|Device|Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.)|
16022340|NCT02722278|Drug|Oral Testosterone Undecanoate|Subjects assigned to oral TU treatment will begin at 237 mg TU twice daily. Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg < 350 ng/dL, decreased if > 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL.
16022341|NCT02722278|Drug|Axiron Testosterone Topical Solution|"Subjects assigned to Axiron treatment will begin at 60 mg Axiron every morning. Axiron is applied to the axilla only.
~Serial PK samples over 24 hours will be obtained after 21 days and 56 days of treatment. Dose adjustments may be made on Day 35 and Day 70, based on the T Cavg results obtained at Day 21 and Day 56, respectively. Dose will be increased if Cavg < 350 ng/dL, decreased if > 800 ng/dL and maintained if Cavg = 350 ng/dL to 800 ng/dL."
16022342|NCT02722265|Drug|CS-3150|CS-3150 2.5mg to 5mg, orally, once daily for 28 or 52 weeks
16022343|NCT02722252|Device|Embryoscope|
16022344|NCT02722252|Device|Embryo culture system without incorporated camera|
16022345|NCT02722239|Drug|Xigduo XR|a single oral dose of modified release fixed dose combination film-coated tablet consisting of 10 mg dapagliflozin IR and 1000 mg metformin hydrochloride extended release
16022346|NCT02722239|Drug|Metformin ER (Glucophage® long)|co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long).
16022347|NCT02722239|Drug|Dapagliflozin (Forxiga)|co-administration of a single oral dose of 10 mg dapagliflozin film-coated tablet (Forxiga™) and two tablets 500 mg metformin hydrochloride extended release tablets (Glucophage® long).
16022348|NCT02722226|Other|Simulation|High fidelity simulation based sedation learning program
16022349|NCT02722226|Device|Airway management|Workshop on using airway management and oxygenation devices.
16022350|NCT02722226|Behavioral|Crisis resource management|Learning crisis resource management principles
16022351|NCT02722213|Behavioral|Mindfulness-Based Stress Reduction (MBSR).|MBSR is a combination of mindfulness meditation, breathing practices, gentle yoga, and other relaxation techniques; it is taught in a manualized 8-week program, does not require special equipment, and can be practiced safely by people of all abilities
16022352|NCT02722200|Drug|hydrocortisone|Hydrocortisone will be used as the steroid of choice because it is bio-identical to cortisol and is subject to the same metabolism as cortisol.
16022353|NCT02722200|Other|saline|Saline will be used as the placebo comparator. It will be administered in the same manner as the active drug.
16022354|NCT02722187|Procedure|subinguinal microscopic varicocelectomy|
16022355|NCT02722187|Procedure|laparoscopic varicocelectomy|
16022356|NCT02722161|Drug|[14C]BI 1482694|
16022357|NCT02722148|Device|Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy|A novel assay developed by the investigator to diagnose food allergens. Results from the assay are used to guide food elimination therapy for the treatment of Eosinophilic Esophagitis (EoE).
16022358|NCT02722135|Drug|Volasertib|
16022359|NCT02722122|Drug|AIR DNase™|
16022360|NCT02722109|Other|No intervention|No intervention will be done
16101170|NCT02154464|Drug|Paracetamol|
16022361|NCT02722096|Drug|Axillary block anesthesia with Ropivacaine and Lidocaine|Axillary brachial plexus block anesthesia with injection of Ropivacaine and Lidocaine will be performed by anesthetist 30 to 45 minutes before surgery
16022362|NCT02722096|Drug|Local anesthesia with Ropivacaine and Lidocaine|Local subcutaneous infiltration of Ropivacaine and Lidocaine will be performed by anesthetist at the beginning of surgery
16022363|NCT02722083|Drug|Chlorpheniramine maleate (BAY X002134)|4 mg tablet, single dose, orally
16022364|NCT02722083|Drug|Placebo|placebo tablet, single dose, orally
16022365|NCT02722070|Device|3 Tesla Siemens Skyra MRI scanner|Standardly used Magnetic resonance imaging (MRI) protocols, including resting state fMRI, task fMRI, T1 weighted imaging
16022366|NCT02722044|Biological|M923|Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)
16022367|NCT02722044|Device|Autoinjector|Subcutaneous administration
16022368|NCT02722018|Drug|GDC-0810 Phase II Tablet|Participants will receive dose level A (in Parts 1 and 2) or dose level B (in Part 3) tablets.
16022369|NCT02722018|Drug|GDC-0810 Phase III Prototype Tablet|Participants will receive dose level A (in Parts 1 and 2) or dose level B (in Part 3) tablets.
16022370|NCT02722005|Behavioral|Financial Coaching|One-to-one financial coaching focused on credit, debt, savings, and income supports.
16022371|NCT02722005|Behavioral|Access to referral to social services|Access to referral to a host of social services.
16022372|NCT02721992|Other|No intervention|No intervention
16022373|NCT02721979|Drug|Apalutamide|Given PO
16022374|NCT02721979|Other|Laboratory Biomarker Analysis|Correlative studies
16022375|NCT02721979|Other|Quality-of-Life Assessment|Ancillary studies
16022376|NCT02721979|Other|Questionnaire Administration|Ancillary studies
16022377|NCT02721966|Biological|Secukinumab|Anti IL-17a monoclonal antibody
16022378|NCT02721966|Drug|Secukinumab and Placebo|Placebo matching AIN457
16022379|NCT02721953|Dietary Supplement|Butyrate|Butyrate
16022380|NCT02721953|Other|Placebo|Placebo
16022381|NCT02721940|Procedure|Control group|Patients in the control group will be subjected to arthroscopic debridement and microfracture surgery.
16022382|NCT02721940|Biological|Mononuclear Cells|In the treatment group, patients will be given 200 μg zoledronic acid and purified bone marrow mononuclear cells will be injected into the necrotic zone, followed by injection of 5-10 mL normal saline. Finally, the holes for core decompression will be sealed with a small amount of bone wax to prevent leakage.
16022383|NCT02721940|Biological|Platelets|In the treatment group, patients will be given 200 μg zoledronic acid and purified bone marrow mononuclear cells will be injected into the necrotic zone, followed by injection of 5-10 mL normal saline. Finally, the holes for core decompression will be sealed with a small amount of bone wax to prevent leakage.
16022384|NCT02721940|Drug|Zoledronic Acid|In the treatment group, patients will be given 200 μg zoledronic acid and purified bone marrow mononuclear cells will be injected into the necrotic zone, followed by injection of 5-10 mL normal saline. Finally, the holes for core decompression will be sealed with a small amount of bone wax to prevent leakage.
16022385|NCT02721940|Drug|Normal saline|In the treatment group, patients will be given 200 μg zoledronic acid and purified bone marrow mononuclear cells will be injected into the necrotic zone, followed by injection of 5-10 mL normal saline. Finally, the holes for core decompression will be sealed with a small amount of bone wax to prevent leakage.
16022386|NCT02721927|Other|Syrian Refugees|Adult Syrian patients who visited the Emergency Department
16022387|NCT02721914|Procedure|GROUP RECEIVING MASSOTHERAPY- HYPOPRESSIVE ABDOMINAL GYMNASTIC|The subjects of this group will receive an amount of eight sessions that will be applied within five weeks; four massotherapy sessions and another 4 of H.A.G. The three first weeks one session of each methodology will be applied, starting always with massotherapy (with sessions on Mondays and Thursdays or on Tuesdays and Fridays). On the fourth week a session of massotherapy will be applied on the same day as usual. And, finally, on the fifth week a session of H.A.G will be applied on the same day as massotherapy is applied.
16022388|NCT02721914|Procedure|GROUP RECEIVING MASSOTHERAPY|"The sessions will be applied for 5 weeks. The first three weeks 2 sessions per week will be applied (whether on Mondays and Thursdays or Tuesdays and Fridays), and during the remaining two weeks only a session will be applied per week, on the first day of the week same as applied before.
~Massotherapy technics will be applied all over the back, covering the thoracolumbar area as well as upper areas reaching the cervix and occiput.
~In particular, posterosuperior iliac spines, iliac crests, ribs, shoulder girdle and the entire spine (sacral bone- lumbar area-backbones-cervical vertebrae) and its attached tissues will be worked down.
~Massotherapy protocol will be applied by the physical therapist, always respecting the postural ergonomics. This enables the verticality of the body (avoiding the slopes) which makes work much easier thanks to the inertia triggered by the load transfer in the lower extremities in both sagittal and horizontal plane."
16022389|NCT02721914|Procedure|GROUP RECEIVING HYPOPRESSIVE ABDOMINAL GYMNASTIC|"The subjects of this group will receive a total of 8 sessions of 30 minutes each; sessions will be applied for 5 weeks. The first three weeks 2 sessions per week will be applied (whether on Mondays and Thursdays or Tuesdays and Fridays), and during the remaining two weeks only a session will be applied per week, on the first day of the week same as applied before.
~The techniques applied are an assembly of rhythm, postural and breathing exercises that have to be done in a systematically. The physical therapist will check that all of the group subjects have assimilated properly the H.A.G and the breathing patterns from the exercises protocol. If they have, then the practical session which comprises 6 hypopressive exercises, can be started.
~The subjects must remain in each position between 10 and 30 seconds and repeat the exercise three times, with a rest period among each that will last at least 20 seconds."
16022390|NCT02721901|Behavioral|iEAT Manual Intervention|The iEAT manual guides caretakers in increasing the volume of food consumed by the child. The manual involves a touch screen application that collects and stores data on key behaviors and provides the feeder with direction for structuring treatment meals. Sessions will be 45 minutes long and occur biweekly for 10 sessions over 5 months. Two meals each day will be completed at home as part of the treatment of the feeding problems.
16022431|NCT02721628|Device|Femtosecond laser|Use in the epic-keratoplasty surgery
16022432|NCT02721615|Procedure|Insertion of intra spinal sub dural pressure monitor|
16022433|NCT02721615|Procedure|Insertion of sub dural microdialysis probe|
16022391|NCT02721901|Behavioral|Control group|The psychoeducation condition will involve 6 appointments (once monthly for 5 months and 1 session during the post-treatment assessment). Each appointment will include curriculum related to feeding concerns such as the etiology of feeding problems, meal structure, appropriate food selection, mealtime problem behaviors, and generalization of appropriate feeding behaviors. Each session will last approximately 45 minutes.
16022392|NCT02721888|Drug|Liraglutide|
16022393|NCT02721888|Drug|MRI/ MRS (Magnetic Resonance Imaging /Magnetic Resonance Spectroscopy)|
16022394|NCT02721888|Biological|Blood sample|
16022395|NCT02721888|Other|Kinetic substudy (10 patients)|
16022396|NCT02721875|Drug|Volasertib|
16022397|NCT02721875|Drug|Volasertib|
16022398|NCT02721875|Drug|Azacitidine|
16022399|NCT02721862|Drug|Ursodeoxycholic Acid|Ursodeoxycholic acid, is FDA approved for the reduction in gallstone formation in obese patients undergoing rapid weight loss.Ursofalk is indicated in the treatment of primary biliary cirrhosis (PBC) and for the dissolution of radiolucent gallstones in patients with a functioning gall bladder.
16022400|NCT02721862|Drug|Placebo|The placebo has the same color and size as the ursodeoxycholic acid 250 mg pill
16022401|NCT02721862|Radiation|Gallbladder Ultrasound|Each patient will undergo a total of three abdominal ultrasounds (at 6 months, at 12 months, and at 18 months after sleeve gastrectomy) to check for gallstones. Patients should be gallstone free on an initial ultrasound to satisfy the study inclusion criteria. Ultrasound testing is radiation free and does not pose any additional risk to the subjects.
16022402|NCT02721849|Behavioral|Yoga for adolescents|12 week hatha yoga course for adolescents
16022403|NCT02721849|Behavioral|Yoga for parents|12 week hatha yoga course
16022404|NCT02721836|Behavioral|Yoga|Yoga intervention 12 weeks, twice weekly 75-minute intervention Yoga postures, breathing, relaxation, and meditation
16022405|NCT02721836|Behavioral|Nutrition Counselling|Evidence-based Nutrition Counselling, 3 appointments within 12 weeks
16022406|NCT02721823|Behavioral|lifestyle-modification|The group intervention is carried out once a week for 10 weeks for a total of 60 hours with elements of mindfulness-based stress reduction (MBSR) and further process of the mind / body medicine. In this project, this program will be adapted to the specific needs of colitis patients.
16022407|NCT02721823|Behavioral|Control group|Participants in this group receive a one-time education unit within the scope of 3 hours on the influence of lifestyle factors on the disease, also self-help materials for independent training offered. Following the follow-up measure also this group is given the opportunity to participate in the multimodal stress reduction- and lifestyle modification program.
16022408|NCT02721810|Behavioral|Consideration of 3-month functional prognosis|
16022409|NCT02721797|Procedure|Orthopaedic & Gynaecology surgery|Patients will have the surgery they require for their treatment. During surgery, debrided tissues will be retained for research. No treatment plans will be altered for this research.
16022410|NCT02721784|Device|mpMRI/VERDICT|Combined MRI sequences of T2, DCE, Diffusion and VERDICT
16022411|NCT02721784|Radiation|External Beam Radiotherapy|78Gy (Gray) to Prostate +/- Pelvic
16022412|NCT02721771|Procedure|Ultrasound examination|echocardiographic diastology and bilateral B-line pattern will be assessed. Optic nerve sheath diameter will be assessed.
16022413|NCT02721758|Behavioral|Brief Motivational Intervention|
16022414|NCT02721745|Behavioral|Natural Fatigue|Experimental: EEG Indirect Calorimetry Pupillometry
16022415|NCT02721745|Device|tDCS|Experimental: EEG Indirect Calorimetry Pupillometry
16022416|NCT02721745|Device|TMS|Experimental: EEG Indirect Calorimetry Pupillometry
16022417|NCT02721732|Other|Laboratory Biomarker Analysis|Correlative studies
16022418|NCT02721732|Biological|Pembrolizumab|Given IV
16022419|NCT02721732|Other|Questionnaire Administration|Ancillary studies
16022420|NCT02721706|Other|CIPA nutritional screening tool|The new nutritional screening tool termed CIPA includes Control of food Intake, Protein, and Anthropometry (CIPA) results positive when at least one of the following parameters is met: control of food intake for 72 h <50%, serum albumin <3 g/dl, body mass index <18.5 kg/m2 or mid-upper arm circumference ≤ 22.5 cm.
16022421|NCT02721693|Device|Treadmill exercise test|Patients are subjected to an incremental exercise test to exhaustion on a treadmill
16022422|NCT02721680|Other|Internal Awareness Training Program|
16022423|NCT02721680|Other|External Awareness Training Program|
16022424|NCT02721667|Device|Telemonitoring|Secure, wireless transmission of home blood pressure measurements that are summarized in a secure health portal for healthcare providers use for clinical management decisions, including calculation of mean BP and graphing of temporal trends.
16022425|NCT02721667|Other|Case Management|Case managers work collaboratively with patients and physicians to optimize health behaviours, monitor risk factors, implement therapeutic adjustments, encourage adherence, and coordinate follow-up care.
16022428|NCT02721641|Drug|Herceptin|Herceptin will be administered as either 2 milligrams per kilogram (mg/kg) once weekly (first dose as a 4-mg/kg loading dose) or 6 mg/kg every 3 weeks (first dose as an 8-mg/kg loading dose) via IV infusion over 90 minutes.
16022429|NCT02721628|Procedure|Epi-keratoplasty|Femtosecond laser assisted Epi-keratoplasty
16022430|NCT02721628|Procedure|Collagen Cross-Linking|Collagen Cross-Linking: Standard procedure, which is descriptor bellows: Corneal epithelium is mechanically removed. Then, a solution of riboflavin is instilled each minute for 30 minutes. Corneas are irradiated by a UVA light for 3mW/cm2 during 30 minutes
16101171|NCT02154464|Drug|Placebo|
16022434|NCT02721602|Behavioral|Families Preventing Diabetes Together|Families in the intervention group will be asked to participate in four in-person sessions at a local Fairview North metropolitan area clinic over the course of two months. Sessions will focus on age-appropriate nutrition and diabetes education, meal planning and cooking skills, healthful eating, and eating meals as a family. All family members will be asked to attend and will be involved in all four, two-hour sessions. The parent with diabetes will also complete one goal setting telephone call based on motivational interviewing techniques during the intervention period.
16022435|NCT02721589|Drug|SHR-1210|PD-1 antibody
16022436|NCT02721576|Drug|Sodium Glycididazole|Sodium Glycididazole 800mg/m2.Three times a week (once every other one day),before radiation therapy, total 5-6 weeks.
16022437|NCT02721563|Drug|Sodium Glycididazole|Sodium Glycididazole 700mg/m2.Three times a week (once every other one day),before radiation therapy, total 6 weeks.
16022438|NCT02721563|Drug|Placebo|Placebo:three times a week (once every other one day),before radiation therapy, total 6 weeks.
16022439|NCT02721550|Drug|Sodium Glycididazole|800mg/m2，dissolved in 100ml physiological saline(Now with chef),ivgtt,finished in 30 minutes,within 60 minutes after intravenous drip for radiation therapy.Three times a week (once every other one day),before radiation therapy, total 4 weeks course.
16022440|NCT02721537|Dietary Supplement|Nicotinamide Riboside|Three capsules, twice per day for 84 days
16022441|NCT02721537|Other|Matching placebo|Three matching capsules, twice per day for 84 days
16022442|NCT02721524|Procedure|Tricuspid Annuloplasty|Patients will undergo repair of tricuspid regurgitation
16022443|NCT02721511|Drug|Furosemide Injection Solution 8mg/mL|Furosemide Injection Solution, 8 mg/mL, (total dose =80 mg) administered subcutaneously as 30 mg over the first hour and then as 12.5 mg per hour over the subsequent 4 hours by means of the B. Braun Perfusor® Space Infusion Pump System.
16022444|NCT02721498|Procedure|Airway clearance session using the Active Cycle of Breathing Techniques (ACBT)|An airway clearance technique incorporating thoracic expansion exercises, breathing control (normal diaphragmatic breathing) and the forced expiration technique (or huffing)
16022445|NCT02721498|Other|Rest period|A 30-60 minute of resting
16022446|NCT02721485|Other|Ringer's Lactate|After a 1 week run in half of participating hospitals will be crossed over to using Ringer's Lactate as 500 or 1000 ml boluses or infusions as specified by the treating physicians for the second 90-day test period.
16022447|NCT02721485|Other|Normal Saline|After a 1 week run in half of participating hospitals will be crossed over to using Normal Saline as 500 or 1000 ml boluses or infusions as specified by the treating physicians for the final 90-day test period.
16022448|NCT02721472|Procedure|micro- and macro-circulatory vascular remodelling measures not practice in routine care|Vascular measures : reactive hyperaemia index (RHI) assessed by Endo-PAT, central aortic blood pressure, aortic augmentation index, carotid-femoral pulse wave velocity
16022449|NCT02721472|Procedure|Biological measures not practice in routine care|Biological measures : Plasma DNA level, NETs (plasma nucleosome levels), Microparticules (MPs) (total, associated with red blood cells, neutrophils, platelets), haem (total and bound to MPs), Myeloperoxydase and elastase activity, neutrophils/DNA, Annexin A5, RNA and TSP1
16022450|NCT02721459|Drug|XL888|"Level 1: XL888 30 mg by mouth (PO) twice weekly (BIW). Level 2: XL888 45 mg PO BIW.
~Level 3: XL888 60 mg PO BIW. Level 4: XL888 90 mg PO BIW."
16022451|NCT02721459|Drug|Vemurafenib|Vemurafenib 720 mg by mouth twice a day (BID)
16022452|NCT02721459|Drug|Cobimetinib|Cobimetinib 40 mg by mouth once daily (QD). Administered 3 weeks on, 1 week off.
16022453|NCT02721446|Behavioral|Standard|"Investigators will develop a standard informational stroke risk message that will not undergo iterative review. This will inform the patient that based on information in the healthcare system, the patient is at higher risk of stroke than many others receiving care in the patient's healthcare system; it will describe options for working with their health care team to reduce the risk of stroke; and encourage the patient to call the health navigator to discuss these options and make a decision about next steps to take to reduce the patient's risk of stroke."
16022454|NCT02721446|Behavioral|Incentive|Investigators anticipate that the baseline incentive stroke risk message will inform the patient that they are at higher risk of stroke than many others receiving care in the patient's healthcare system, and will provide information about obtaining an incentive if the patient calls to make contact with a health navigator who will help them plan a next step to reduce their stroke risk. The investigators also anticipate including information that all patients who call will also be entered in a random drawing to receive an additional incentive, with up to six patients receiving this incentive.
16022455|NCT02721446|Behavioral|Salience|"Investigators anticipate that the baseline salience stroke risk message will inform the patient that they are at higher risk of stroke than many other patients receiving care in the patient's healthcare system, and will specifically focus on the patient's own risk factors (rather than all stroke risk factors). The salience message will also include visual depictions of stroke patients that are gender and ethnically matched to each subject. This is intended to prompt action by emphasizing that stroke is a real possibility for patients like me."
16022456|NCT02721446|Behavioral|Incentive + Salience|Combined message of incentive plus salience.
16022457|NCT02721433|Drug|Pamidronate|Bone-targeted agent as standard of care
16022458|NCT02721433|Drug|Denosumab|Bone-targeted agent as standard of care
16022459|NCT02721433|Drug|Zoledronate|Bone-targeted agent as standard of care
16022460|NCT02721420|Drug|dihydroartemisinin-piperaquine|
16022461|NCT02721420|Other|message(SMS) reminder|
16022462|NCT02721420|Other|Health worker reminder|Health surveillance assistants reminders prior to each treatment course
16022463|NCT02721420|Other|short message(SMS) reminder|
16022464|NCT02721407|Drug|Retroviral vector-transduced autologous T cells to express CD22-specific CARs|
16022465|NCT02721394|Behavioral|Functional Communication Training|Functional Communication Training (which aims to teach the child a communicative alternative to challenging behaviour) implemented by either the researcher or family carer.
16022526|NCT02720926|Drug|Xeloda,|Capecitabine (xeloda): 2000mg/m2, twice a day on Day 1-14;
16022527|NCT02720926|Drug|Oxaliplatin|Oxaliplatin: 130mg/m2 day 1 every 21days
16022528|NCT02720926|Drug|TKI258|4 dose levels of TKI258: 200mg, 300mg, 400mg, 500mg once daily, 5days on and 2 days off;
16023264|NCT02715570|Drug|PC945 - repeat doses|Safety and tolerability of repeat doses
16022466|NCT02721381|Behavioral|ImPACT Online|ImPACT Online is an interactive, web-based telehealth intervention that teaches parents to promote their child's social-communication skills during play and daily routines. The intervention content was adapted from Project ImPACT, a manualized parent training curriculum that uses a blend of developmental and naturalistic behavioral intervention techniques, including following the child's lead, imitating the child, using heightened animation, using simplified language around the child's focus of attention, environmental arrangement strategies, prompting, and natural reinforcement during child-directed activities. There is strong empirical support for the intervention techniques for increasing social communication in children, increasing parent fidelity, and child language skills.
16022467|NCT02721368|Device|Neuramis® Volume Lidocaine|hyaluronic acid filler
16022468|NCT02721368|Device|Juvederm® Voluma® with Lidocaine|hyaluronic acid filler
16022469|NCT02721355|Dietary Supplement|GastimunHP|Health food supplement containing specific IgY against urease of H. pylori
16022470|NCT02721342|Drug|Ramipril, Irbesartan and Atorvastin|
16022471|NCT02721329|Device|APAP|Automatic Continuous Positive Airway Pressure
16022472|NCT02721329|Device|APAP with SensAwake|Automatic Continuous Positive Airway Pressure with SensAwake enabled. SensAwake is a pressure relief technology that detects the transition from sleep to wake, and promptly reduces the pressure during wakeful periods.
16022473|NCT02721316|Other|Supported with intensive nursing follow post hospitalization|Intensive nursing follow post - hospitalization
16022474|NCT02721303|Dietary Supplement|3-day diet Run-in|Participants will be studied on one occasion after a 3-day diet run-in. This will be followed by a breakfast meal.
16022475|NCT02721303|Procedure|fMRI|After a 3-day diet run-in, participants will undergo a functional magnetic resonance imaging procedure (fMRI). Repeat fMRI will be performed 30 minutes after the meal.
16022476|NCT02721303|Procedure|Intravenous catheter placed for blood draws|On the study day participants will present in the fasting state, have an intravenous catheter placed for blood draws and have baseline blood samples taken. Blood and appetite measures will be performed every half hour for 3 hours.
16022477|NCT02721290|Procedure|Femoral nerve block using Ultrasound and neurostimulator|
16022478|NCT02721290|Procedure|Femoral nerve block using Ultrasound|
16022479|NCT02721290|Drug|Ropivacaine 0.5%|Ropivacaine 0.5% (20cc total) will be injected for the performance of the block in the two arms of the study.
16022480|NCT02721277|Drug|SMOFlipid|SMOFlipid contains a mixture of 4 different lipid sources: soybean oil which provides essential fatty acids, olive oil which is high in monounsaturated fatty acids that are less susceptible to lipid peroxidation than polyunsaturated fatty acids, medium-chain triglycerides which show a faster metabolic clearance than long-chain triglycerides, and fish oil which provides the supply of omega-3 fatty acids.
16022481|NCT02721264|Biological|Fecal Microbiota Transplant|
16022482|NCT02721264|Other|Standard Medical Treatment|
16022483|NCT02721251|Behavioral|Exercise|16 weeks. 4 days per week of aerobic exercise; 45 min for 2 days and for 30 min for two days. 2 days per week of resistance exercise for 15 min (coinciding with the days involving 30 min of aerobic exercise)
16022484|NCT02721251|Behavioral|Weight Loss|16 week. the goal is 10% weight loss.
16022485|NCT02721251|Behavioral|Exercise + Weight Loss|Combined exercise and weight loss components of the other arms
16022486|NCT02721238|Biological|20% Albumin|
16022487|NCT02721238|Other|Plasmalyte|
16022488|NCT02721225|Dietary Supplement|Fructooligosaccharide|"A prebiotics defined as selectively fermented ingredients that allow specific changes, both in the composition and/or activity in the gastrointestinal microbiota that confers benefits upon host well-being and health"
16022489|NCT02721225|Dietary Supplement|Pocari-Sweat|Commercially used isotonic solution produced by Otsuka Pharmaceuticals Co. Ltd., Tokyo, Japan.
16022490|NCT02721212|Device|Armeo Spring|"All patients of experimental group were treated according to an established protocol for ARMEO Spring. In the first session the device was adjusted for patients arms. The physiotherapist controlled functional space of upper limb movement and correct position of working station.
~Each training session consisted of two parts with 30 minutes per session with Armeo Spring and 30 minutes per session with conventional treatment 5 days per week, for 6 weeks."
16022491|NCT02721212|Other|Conventional Rehabilitation|"The conventional treatment, under control of physiotherapist, consists of passive and active assisted mobilization of the upper limbs traditional training based on the Bobath concept (neuromuscular facilitation, postural control and proprioception exercises, verticalization and gait training).
~Each training session consisted of 60 minutes with conventional treatment 5 days per week, for 6 weeks in a control group.
~The conventional session in the experimental group lasted 30 minutes with the same techniques and methods."
16022492|NCT02721199|Other|Neural Respiratory Drive Automated EMGpara assessment|Neural respiratory drive will be measured using surface electrodes and nasal cannula . The 2nd intercostal space will be identified by bony landmarks and skin preparation will be performed using detergent wipes, followed by EMG preparation gel with final cleaning to remove exfoliated skin. Wet gel electrodes will be placed immediately adjacent to the sternal border in the 2nd intercostal space and will be connected to the automated EMG analysis system. Electrodes will remain in place for the duration of the study. A nasal cannula will be placed in the nose and detect pressure changes during respiration in order to ensure accurate detection of inspiratory cycle. In addition, an accelerometer will be attached to the thorax of the patient
16022493|NCT02721186|Drug|MDA with DHAp and SLD Primaquine|
16022494|NCT02721173|Drug|Tazarotene 0.1% gel plus clindamycin 1% gel|Medications will be advised to apply once daily in the evening after facial cleansing. Clindamycin will be applied first and tazarotene will be applied 5-10 minutes later.
16022495|NCT02721173|Drug|Adapalene 0.1% gel plus clindamycin 1% gel|Medications will be advised to apply once daily in the evening after facial cleansing. Clindamycin will be applied first and adapalene will be applied 5-10 minutes later.
16022529|NCT02720913|Device|COR-KNOT|The COR-KNOT device was developed to make suture fixation faster and save operative time. With a single squeeze of the lever, the device remotely and automatically secures sutures with a titanium fastener, while also simultaneously trimming excess suture tails.
16022530|NCT02720913|Procedure|Standard Suture Tying|Standard Suture Tying
16022531|NCT02720900|Dietary Supplement|B-GOS|1.8 g/day for 6 weeks
16022532|NCT02720900|Dietary Supplement|Maltodextrin|1.8 g/day for 6 weeks
16022496|NCT02721160|Other|Nutrition PBF|"Nutrition PBF focuses on children under five years old. It follows the standard PBF model in Burundi and combines quantitative indicators to encourage an increase in service delivery (see Table below) and qualitative indicators. Quality of nutrition activities is assessed quarterly, and a bonus or penalty is applied to subsidies received by the facilities according to their quality score.
~Table: Incentivized indicators
~CHW level
~nb of cases screened and referred to HC for acute malnutrition (AM)
~nb of classes promoting good nutrition
~HC level
~nb of cases screened and cared for severe and moderate AM
~nb of growth follow-ups
~Hospital level
~nb of treated severe AM cases with complications
~length of the stay
~All hospitals with nutrition services fall under the Nutrition PBF program. At lower levels, only HCs in the intervention group and the CHW that refer to them are subject to the Nutrition PBF."
16022497|NCT02721147|Behavioral|Intimacy Enhancing Intervention|Participants attend 4 intimacy enhancement intervention sessions over 75 minutes every other week for 4 weeks. The intimacy enhancement intervention comprises 4 main sessions: understanding impact of breast cancer on sex and intimacy, communication about sex/intimacy, problem-solving and changing thoughts, and planning ahead and preparing for challenges. Participants are encouraged to participate in written and behavioral activities at home.
16022498|NCT02721147|Behavioral|Living Healthy Together|Participants receive educational information and support about breast cancer every other week for 4 weeks. The educational information and support comprises topics about breast cancer, its treatments, sleep, energy, stress, stress management, nutrition, and diet. Participants are encouraged to read educational materials.
16022499|NCT02721147|Behavioral|Partner-Assisted Coping Skills Training|Receive couple-based intimacy enhancement intervention
16022500|NCT02721147|Behavioral|Behavioral, Psychological or Informational Intervention|Receive educational information and support
16022501|NCT02721134|Other|additional blood tubes|four whole blood tubes 5 ml (2 + EDTA tubes separating gel and dry tubes 2 + separating gel ) will be taken in order to assay more bacterial biomarkers on day 0 , J1, J2, J3 and J5
16022502|NCT02721121|Procedure|circumferential pulmonary vein isolation|
16022503|NCT02721121|Procedure|Linear ablation in addiction to circumferential pulmonary vein isolation|
16022504|NCT02721108|Behavioral|Mindfulness meditation|The meditation content is a structured and progressive course, layering in new techniques and concepts over successive sessions. The course was created and narrated by a former monk - Andy Puddicombe - drawing on a secularised version of the techniques he was taught over 10 years' experience in monasteries around the world. The first 30 days cover basic techniques, assuming no previous experience of meditation. The second 30 days focus specifically on the use of these techniques with respect to pain. The duration of individual sessions builds over time. Days 1-10 are 10 minutes in duration, days 11-20 are 15 minutes in duration, and days 21-60 are 20 minutes in duration.
16022505|NCT02721108|Behavioral|Relaxation app|The Active Control group will use the same app, but the app will be configured so that they will hear a series of non-meditative progressive muscle relaxation instructions, also narrated by Andy Puddicombe. These sessions will be identical every day, except that their duration will increase to mirror the increasing duration of the meditation content being listened to by the Intervention group.
16022506|NCT02721095|Other|KCl plus 0.9%NaCl|comparison of KCl plus 0.9%NaCl and KCl plus 0.45%NaCl for correction of hypokalemia
16022507|NCT02721095|Other|KCl plus 0.45%NaCl|comparison of KCl plus 0.9%NaCl and KCl plus 0.45%NaCl for correction of hypokalemia
16022508|NCT02721082|Behavioral|Opt Out Treatment Program|Tobacco Treatment (UKanQuit) staff will complete a treatment plan for all participants.
16022509|NCT02721082|Drug|Nicotine Replacement Therapy|Unless they Opt Out all participants will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
16022510|NCT02721082|Behavioral|Opt In Treatment Program|Tobacco Treatment (UKanQuit) staff will complete a treatment plan for participant's who are ready to quit smoking. For patient's not ready to quit, motivational counseling will be provided to participants based on principles of Motivational Interviewing.
16022511|NCT02721082|Drug|Nicotine Replacement Therapy|Participants ready to quit will be provided with a 14 day supply of the nicotine patch and nicotine mini-lozenges or nicotine gum, depending on study related criteria.
16022512|NCT02721069|Drug|NRL-1|
16022513|NCT02721056|Radiation|NBTXR3, IL or IA injection + SBRT|Patients will receive a single administration of NBTXR3 on day of injection, as intralesional or super selective transcatheter arterial injection activated by Stereotactic Body Radiation Therapy starting 24 hours post injection. The total radiotherapy dose will be 45 or 50 Gy, delivered as three fractions of 15 Gy or 5 fractions of 10 Gy each, over 5 to 15 days (45 or 50Gy, 15GyX3 or 10GyX5).
16022514|NCT02721043|Biological|Peptides|Each subject will receive ten (10) total doses of PGV001. PGV001 will be administered on study visit: v4, v6, v8, v10, v12, v14, v16, v18, v20 and v22.
16022515|NCT02721043|Drug|Poly-ICLC|Each subject will receive ten additional (10) total doses of the Poly-ICLC. The additional Poly-ICLC dose will be administered on study visit: v5, v7, v9, v11, v13, v15, v17, v19, v21 and v23.
16022516|NCT02721043|Drug|Lenalidomide|10mg once daily oral dose for maintenance therapy in multiple myeloma patients.
16022517|NCT02721017|Device|Cryoanalgesia|
16022518|NCT02721017|Drug|Thoracic epidural (ropivicaine, fentanyl)|Epidural infusion was begun with with 0.1% ropivicaine and 2 mg/cc fentanyl.
16022519|NCT02721004|Drug|Tocilizumab|Tocilizumab administered as an intravenous infusion every 4 weeks according to product label/per standard practice for a maximum of 12 months will be observed in this study.
16022520|NCT02720991|Drug|Mifepristone|200 mg of oral mifepristone
16022521|NCT02720991|Drug|Sublingual misoprostol|400 ug of misoprostol sublingually following mifepristone
16022522|NCT02720978|Drug|Intravenous oxytocin|"Intravenous oxytocin chosen randomly. we will collect basic and obstetric data, laboratory results and physical examination, monitoring and sonar.
~Induction according to departmental protocol of each delivery way. Data collecting after the delivery."
16022523|NCT02720978|Drug|vaginal prostaglandin|"Vaginal prostaglandin chosen randomly. we will collect basic and obstetric data, laboratory results and physical examination, monitoring and sonar.
~Induction according to departmental protocol of each delivery way. Data collecting after the delivery."
16022524|NCT02720965|Other|Remote-controlled perineural local anesthetics delivery|Remote-controlled perineural local anesthetics delivery
16022525|NCT02720952|Drug|Infacort®|dry granule formulation of hydrocortisone
16022533|NCT02720887|Procedure|Nanoparticles load|Pregnant women will have a sampling of amniotic fluid to measure load and composition of nanoparticles.
16022534|NCT02720874|Behavioral|Rheumatoid arthritis educational booklet|Participants will receive a low-literacy rheumatoid arthritis educational booklet that provides general disease state information.
16022535|NCT02720874|Behavioral|Multidisciplinary rheumatologic care|At each regularly scheduled clinic appointment, participants will receive treatment from their assigned rheumatologist, undergo an in-clinic physical therapy evaluation and, if indicated, a psychological evaluation. Physical therapy and psychology follow-up sessions will occur as directed by the individual services.
16022536|NCT02720874|Behavioral|Nurse education and monthly calls|Participants will meet one-on-one with a rheumatology nurse for a tailored educational session encompassing disease state education, an introduction of the treat to target concept, an overview of treatment options, and goal setting and planning. During monthly follow-up calls, participant educational needs will be addressed; goal setting, planning and review will also be conducted.
16022537|NCT02720874|Behavioral|Monthly healthcare coordinator calls|During monthly calls with the healthcare coordinator, specific questions and concerns raised by participants may be addressed. The primary purpose of these calls is to control for potential benefit derived from time on the phone with a health professional.
16022538|NCT02720874|Behavioral|Technology-based symptom monitoring and reporting|When at home patient self-monitoring reports indicate a significant increase in RA disease activity, participants will be promptly contacted and scheduled for an ad hoc evaluation with their treating rheumatologist.
16022539|NCT02720861|Genetic|DNA sequencing|withdraw 3m blood from vein only once during the whole design to analyse on DNA sequencing on RNF213 rs112735431 Gene
16022540|NCT02720848|Device|Stiffening wire|The stiffening wire will be inserted into the double/single balloon enteroscope.
16022541|NCT02720848|Device|Standard technique|The double/single balloon enteroscope will be used without the stiffening wire as per standard technique.
16022542|NCT02720822|Drug|Placebo|Treatment with placebo is given as one double-blind capsule in the morning.
16022543|NCT02720822|Drug|Morphine Sulfate|Treatment with sustained-release morphine sulfate is given as one double-blind capsule in the morning.
16022544|NCT02720822|Drug|Plus laxative (Docusate with senna)|If patients are taking morphine, a laxative will be offered. This applies whatever the dose of morphine being taken (8mg, 16mg, 24mg or 32 mg).
16022545|NCT02720822|Drug|Plus placebo laxative|If the patients are taking placebo, a placebo laxative will be offered.
16022546|NCT02720822|Device|FitBit charge HR (Accelerometer)|A Fitbit will be worn by patients during week 1 and week 3.
16022547|NCT02720796|Other|PDX drug sensitivity testing|Patient derived xenograft (PDX) models will be developed for each patient and drug activity assessed in their personalized PDX model. PDX drug sensitivity information will be provided to the treating physician.
16022548|NCT02720783|Drug|Econazole nitrate 150 mg plus Benzydamine HCl 6 mg vaginal pessary|Econazole nitrate 150 mg plus Benzydamine HCl 6 mg vaginal pessary
16022549|NCT02720783|Drug|Placebo plus Econazole nitrate 150 mg vaginal pessary|
16022550|NCT02720783|Drug|Placebo plus Benzydamine HCl 6 mg vaginal pessary|
16022551|NCT02720783|Drug|Placebo vaginal pessary|
16022552|NCT02720770|Drug|norditropine simplex|
16022553|NCT02720757|Drug|Spiolto Respimat|Tiotropium bromide + Olodaterol
16022554|NCT02720744|Drug|Sodium Oxybate|
16022555|NCT02720744|Drug|Placebo|
16022556|NCT02720718|Device|Stratafix|
16022557|NCT02720718|Device|Vicryl|
16022558|NCT02720705|Drug|Dexmedetomidine|oral dexmedetomidine
16022559|NCT02720705|Drug|saline|2ml 0.9% saline administered orally half an hour before induction of anesthesia
16022560|NCT02720692|Drug|N1539|
16022561|NCT02720692|Drug|Intravenous Placebo|
16022562|NCT02720666|Drug|K-001|In case of severe adverse reactions associated with the test drug, or if half of the participants show adverse reactions at Ⅲ level and above, the test should be terminated. The maximum dosage not causing the above-described situation shall be considered as the maximum tolerated dose or the biologically effective dose. After the test, continuous medication shall be given upon request from patients.
16022563|NCT02720653|Procedure|Endoscopic sinus surgery|
16022564|NCT02720640|Device|Implant 'on' vs implant 'off'|Single group assignment
16022565|NCT02720627|Drug|cortexolone 17α-propionate|CB-03-01 cream is a topical steroidal antiandrogen that is being developed for the potential treatment of acne vulgaris, an androgen-dependent skin disorder.
16022566|NCT02720614|Radiation|Hypofractionated radiation/chemotherapy|Procedure: Radiation Therapy Drug: Vinorelbine Drug: Carboplatin Drug: Paclitaxel Drug: Cisplatin
16022567|NCT02720601|Drug|Irinotecan & Capecitabine|Irinotecan will be administered at infusion room over 60 minutes. Capecitabine will be administered by the patients at home. Unless there is early progression of disease, at least two courses will be administered to each patient. Repeated courses may be given to the patients who benefit from the treatment (either complete or partial remission, or stabilization of disease)
16022568|NCT02720575|Other|Consumption of capsule/bread with vitamin D|
16022569|NCT02720549|Procedure|remote ischemic postconditioning|Remote ischemic postconditioning post group will take a remote ischemic postconditioning with tourniquet in their lower extremity under thigh. The conditioning is 5 minutes of inflation, and 5 minutes of deflation, repeated 3 cycles.
16022570|NCT02720549|Procedure|valvular surgery with bypass|valvular surgery with bypass
16022571|NCT02720536|Drug|Deferasirox|Deferasirox FCT will be provided as 90 mg, 180 mg and 360 mg film-coated tablets for oral use.
16022572|NCT02720523|Drug|Placebo|Tablet; Oral
16022573|NCT02720523|Drug|Upadacitinib|Tablet; Oral
16022574|NCT02720510|Drug|Revlimid|Revlimid was used with dexamethasone to treat patients with multiple myeloma
16022575|NCT02720510|Drug|Velcade|Velcade was a proteasome inhibitor indicated for treatment of patients with multiple myeloma
16022576|NCT02720510|Drug|dexamethasone|Dexamethasone was a steroid used to treat patients with multiple myeloma.
16022577|NCT02720510|Drug|Farydak|FARYDAK® (panobinostat) capsules was a prescription medicine used, in combination with bortezomib and dexamethasone, to treat adults with a type of cancer called multiple myeloma after at least 2 other types of treatment have been tried.
16102429|NCT02144857|Drug|Secukinumab|300 mg
16022578|NCT02720497|Behavioral|60-minute Prolonged Exposure Therapy|This treatment condition is a modified version of Prolonged Exposure therapy for PTSD. It consists of weekly weekly 60-minute sessions, with 20 minutes imaginal exposure.
16022579|NCT02720497|Behavioral|90-minute Prolonged Exposure Therapy|Prolonged Exposure Therapy for PTSD consists of weekly 90-minute sessions, with 40 minutes imaginal exposure.
16022580|NCT02720484|Other|Laboratory Biomarker Analysis|Correlative studies
16022581|NCT02720484|Drug|Nivolumab|Given IV
16022582|NCT02720471|Drug|Locoregional anesthesia|classical analgesia by ultrasound guidance by blocks of the femoral and cutaneous nerves side of the thigh
16022583|NCT02720471|Drug|peroperative infiltration of local anesthetics|peroperative infiltration of local anesthetics
16022584|NCT02720458|Other|Standardized gradual hypnotic taper|The gradual hypnotic taper is standardized and is adjusted depending on the hypnotic treatment and the initial weekly dose. The practitioner will give to the patient a calendar for the taper period with the specific dose for each day (name of hypnotic, quantity and dose of pills).
16022585|NCT02720458|Behavioral|Short-term simple self-help program|"The short-term simple self-help program consists in:
~Restriction of time in bed
~Stimulus control instructions
~The restriction of time in bed would be delivered by an e-health tool (web site). The patient will have to connect to the web site with an individual connexion password. He will connect every day to complete an on-line sleep diary during the period of the simple short-term behavioural program (5 weeks). After this period, patients will have the choice to continue connecting to the website and using the program or to stop using the program."
16022588|NCT02720432|Other|CIMT|Constraint-induced movement therapy
16022589|NCT02720432|Other|HABIT|hand-arm bimanual intensive training
16022590|NCT02720432|Other|baby-massage|instructions for baby-massage
16022591|NCT02720406|Drug|Intravenous ketamine0.5mg/kg|Intravenous ketamine 0.5mg/kg after anesthesia and before surgery.
16022592|NCT02720406|Drug|Nebulized Ketamine 1mg/kg|Nebulized Ketamine 1mg/kg given by nebulizer before anesthesia.
16022593|NCT02720406|Drug|Nebulized Ketamine 2mg/kg|Nebulized Ketamine 2mg/kg given by nebulizer before anesthesia.
16022594|NCT02720406|Drug|saline placebo|Saline 0.9% given by nebulizer before anesthesia and iv after anesthesia and before surgery.
16022595|NCT02720393|Other|No-carrageenan diet|Diet of food items that have no carrageenan as selected by study dietician.
16022596|NCT02720393|Other|Regular Diet|Diet of food items that have carrageenan as selected by study dietician
16022597|NCT02720380|Other|Buteyko|Intervention will be held twice a week during 3 weeks.
16022598|NCT02720380|Other|Asthma education|Educational interventions in relation to asthma will be given to children assigned to the control group.
16022599|NCT02720367|Drug|Gemcitabine-Releasing Intravesical System (GemRIS)/TAR-200|TAR-200 is a passive, nonresorbable gemcitabine-releasing intravesical system whose primary mode of action is the controlled release of gemcitabine into the bladder over an indwelling period.
16022600|NCT02720354|Other|[11C]-DMDPA|
16022601|NCT02720341|Device|ARMin|single sessions of about one hour each
16022602|NCT02720328|Biological|Blood samples for DOAC measurement|
16022603|NCT02720315|Procedure|Intensive cryotherapy|Application of ice inside a plastic bag wrapped to the patient's site of pain, and held in place for 20min.
16022604|NCT02720302|Behavioral|SOFT|SOFT is based on systemic and solution-focused theories to change lifestyle and has shown positive effects on children with respect to the degree of obesity, physical fitness, self-esteem and family functioning.
16022605|NCT02720302|Behavioral|TeleSOFT|The therapists communicate with the overweight child and his/her family by the SOFT method on distance by use of video.
16022606|NCT02720289|Other|Video-based social learning class|Brief child passenger safety lecture by a child passenger safety technician and viewing of a car seat video.
16022607|NCT02720289|Other|Traditional didactic class|Child passenger safety lecture by a child passenger safety technician.
16022608|NCT02720276|Other|Training after acute stroke|Outdoor walking: Participants will receive daily training instructions via Short message Service (SMS) over 12 weeks. The walks are increased in frequency and intensity. The intensity are rated using the Borg scale to 12-15. The first 2 weeks begins with daily walks of 10 minutes. The last 4 weeks the walk training will partly be performed in intervals in combination with conventional outdoor walks. The interval training includes warming-up (5 minutes), fast walking for 4 minutes alternated with slower walking for three minutes. This is repeated 3 times, followed by cooling down for about five minutes. Strength training: to repeatedly get up from sitting. Number of repetitions will increase from 5-20 per set and will be performed daily in 3 sets with a short rest between each set.
16022609|NCT02720263|Drug|ASP4345|Oral
16022610|NCT02720263|Drug|Matching Placebo|Oral
16022611|NCT02720250|Dietary Supplement|Omega-3 chicken eggs|Intake of 3 omega-3 fatty acids enriched chicken eggs per day for three weeks.
16022612|NCT02720250|Dietary Supplement|Regular chicken eggs|Intake of 3 regular chicken eggs per day for three weeks.
16022613|NCT02720237|Behavioral|Brief Intervention|In-person individual sessions (occurring one month apart) and booster phone sessions (occurring 2-3 weeks after each in-person session), delivered by a trained counselor.
16022614|NCT02720237|Behavioral|Motivational Enhancement Therapy (MET) Intervention|In-person individual sessions (one session per week) and optional group sessions, delivered by a trained counselor.
16022615|NCT02720237|Behavioral|Cognitive Behavioral Therapy (CBT) Intervention|In-person individual sessions (one session per week) and optional group sessions, delivered by a trained counselor.
16022616|NCT02720224|Drug|Estetrol|15 mg [14C]-estetrol containing approximately 2.8 MBq (76 μCi) 14C
16022617|NCT02720211|Device|Gray tinted spectacle lenses|A neutral gray optical tint designed to block all wavelengths in the visible spectrum
16022618|NCT02720211|Device|Thin-Film spectacle lenses|A thin film optical notch filter designed to block 480-nm light in the visible spectrum
16022738|NCT02719353|Device|comfilcon A Extended Range test lens|contact lens
16022739|NCT02719353|Device|comfilcon A control lens|contact lens
16022619|NCT02720198|Drug|Levomilnacipran|treating major depression. A flexible dose regime of levomilnacipran ER 20-120 mg/d mg per day starting at 20 mg/d on Days 1-2, increasing to 40 mg/d on Days 3-7 in week 1, then flexibly dosed between 40 mg/d -120 mg/d during weeks 2 through 8
16022620|NCT02720198|Drug|Quetiapine|Quetiapine will be started at 50 mg/d on Day 1-2, increasing to 150 mg/d on Days 3-7 in Week 1 and then flexibly dosed between 150-300 mg/d during Weeks 1 through 8 along with their current antidepressant.
16022624|NCT02720172|Behavioral|Early Home Exercise Program|The early home exercise program is a 6-week program of home exercises with weekly phone calls to monitor progression and compliance.
16022625|NCT02720172|Other|Usual Care|Usual care involves standard postoperative management under the direction of the treating surgeon.
16022626|NCT02720159|Device|Percutaneous Osseintegrated Prosthesis|
16022627|NCT02720133|Biological|biochemical parameters|"patients will be collected for analysis of blood standard examinations such as blood glucose, electrolytes (potassium, sodium, magnesium calcium), renal function and also the blood count, platelet aggregation.
~All these tests should be practice before, during and after Ramadan fasting for comparison."
16022628|NCT02720120|Drug|Ocrelizumab|Participants will receive single IV infusion of ocrelizumab at 400, 1000, 1500, and 2000 mg.
16022629|NCT02720120|Drug|Placebo|Participants will receive single IV infusion of placebo.
16022630|NCT02720107|Drug|fingolimod|
16022631|NCT02720094|Drug|Cabotegravir tablets|30 mg tablets
16022632|NCT02720094|Drug|TDF/FTC tablets|300 mg/200 mg fixed-dose combination tablets
16022633|NCT02720094|Drug|TDF/FTC placebo tablets|
16022634|NCT02720094|Drug|CAB placebo tablets|
16022635|NCT02720094|Drug|CAB LA|Administered as one 3 mL (600 mg) IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
16022636|NCT02720094|Drug|Placebo for CAB LA|Administered as one 3 mL IM injection in the gluteal muscle at two time points 4 weeks apart and every 8 weeks thereafter
16022637|NCT02720081|Drug|MK-1029 150 mg|150 mg tablet administered orally, once a day (QD), at bedtime
16022638|NCT02720081|Drug|MK-1029 Matching-image Placebo|Matching-image placebo tablet administered orally, QD, at bedtime
16022639|NCT02720081|Drug|Montelukast 10 mg|10 mg tablet administered orally, QD, at bedtime
16022640|NCT02720081|Drug|Albuterol/Salbutamol 90 mcg - 100 mcg per inhalation|1 or 2 inhalations 4 times a day (QID) as needed (PRN) as a Rescue Medication
16022649|NCT02720055|Other|Psychological workbook|
16022650|NCT02720055|Other|Basic information workbook|Basic rehabilitation information that represents current practice.
16022651|NCT02720042|Device|Phasix™ Mesh|A resorbable mesh prepared from poly-4-hydroxybutyrate (P4HB)
16022652|NCT02720029|Device|pH/impedance monitor|Placement of pH/impedance monitor via the nasogastric route with monitoring for 24 hours, followed by removal.
16022653|NCT02720016|Behavioral|CBCT-Home Based (CBCT-HB)|Couples in CBCT-HB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks to the Veterans home via home-based clinical video teleconferencing (CVT).
16022654|NCT02720016|Behavioral|CBCT-Office Based (CBCT-OB)|Couples in CBCT-OB will receive 8 sessions of standardized Cognitive-Behavioral Conjoint Therapy (CBCT), a manualized couple-based intervention for PTSD designed to simultaneously reduce PTSD and enhance relationship and functioning. The psychotherapy is administered over 8 to 15 weeks in-person in the therapist's office.
16022655|NCT02720016|Behavioral|PTSD Family Education (PFE)|Couples in the PFE condition will receive 8 sessions of standardized PTSD Family Education, a manualized psychoeducational program designed to help couples learn more about posttraumatic stress disorder and related difficulties. This psychotherapy is administered over 8 to 15 weeks and is delivered in-person in the therapist?s office.
16022656|NCT02720003|Device|LTX DCB|Treatment with a drug-coated balloon
16022657|NCT02719990|Drug|somavaratan|Long-acting recombinant human growth hormone therapy administered subcutaneously twice-monthly
16022658|NCT02719977|Drug|CX5461|
16022659|NCT02719964|Other|Visual Attention Program (UCR Games)|This program is an individual-directed computerized cognitive rehabilitation program based on perceptual learning approaches to enhance visual attention. Training incorporates a diverse set of stimuli, optimized stimulus presentation, multisensory facilitation, and consistently reinforcing training stimuli. This will be completed in a group setting with an instructor available to facilitate questions.
16022660|NCT02719964|Other|Speech Pathologist-Directed Therapy|This is a speech pathologist-directed arm and will provide a traditional clinician-directed individualized cognitive rehabilitation program. Cognitive treatment is a systematic, functionally oriented program of therapeutic activities that focuses on strengthening previously learned patterns of behavior, establishing new patterns through use of internal and external compensatory cognitive strategies, and enabling the individual to adapt to the changes in his or her revised approaches to cognitive functioning. Increased performance success is reinforced through repetition, errorless learning, and gradually increasing task stimuli and complexity in a structured systematic approach.
16022661|NCT02719964|Other|General Cognitive Rehabilitation Games (Lumosity)|Lumosity is a commercially available computerized program purported to enhance cognitive functioning through a variety of computerized programs that utilize various cognitive abilities.
16022662|NCT02719951|Drug|[18F]FPEB PET imaging|PET exam
16022663|NCT02719951|Other|Biological samples|blood sample and urine sample
16022664|NCT02719951|Other|MRI|MRI exam
16022665|NCT02719938|Behavioral|Specialty Palliative Care|Specialty inter-disciplinary Palliative Care consultation during hospitalization with post-discharge collaborative care by a Palliative Care Nurse Practitioner and outpatient primary care physician. Clinical care will be augmented by evidence-based educational materials for dementia caregivers.
16022666|NCT02719925|Other|Mg(+)|"1,5 L per day during 30 days
~No livestyle counseling"
16022667|NCT02719925|Other|Mg(-)|1,5 L water per day during 30 days No lifestyle counseling
16022668|NCT02719912|Device|mitral valve replacement|transcatheter mitral valve replacement
16022669|NCT02719886|Device|Ultrasound|Estimation of fetal weight by ultrasound
16022670|NCT02719873|Other|The impact of maternal obesity on pregnancy outcomes|observation of maternal obesity effect in foetal and maternal outcome
16022671|NCT02719860|Dietary Supplement|Green tea|4 cups/day of green tea for 6 months; each cup is prepared by brewing 2 tea bags in 12 oz of water
16022672|NCT02719860|Dietary Supplement|Black tea|4 cups/day of black tea for 6 months; each cup is prepared by brewing 2 tea bags in 12 oz of water
16022673|NCT02719860|Dietary Supplement|Placebo tea|4 cups/day of placebo tea for 6 months; each cup is prepared by brewing 2 tea bags in 12 oz of water
16022674|NCT02719847|Procedure|Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)|Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed after PET/CT, and before participant receives stereotactic body radiation therapy (SBRT). EBUS-TBNA results compared with the results of PET/CT.
16022675|NCT02719834|Drug|Acetaminophen|Acetaminophen (regular strength) will be provided in two capsules: 325 mg, take two capsules 3 times/day for 28 days (1,950 maximum daily dose). Capsules will be labeled to maintain blinding.
16022676|NCT02719834|Other|Placebo|The placebo will be provided in the same type of capsules as the acetaminophen. Two capsules, given 3x a day for 28 days. Capsules will be labeled to maintain binding.
16022677|NCT02719821|Behavioral|Behavioral techniques|"Learning behavioral techniques designed to improve nighttime sleep quality and daytime activity for approximately 45-60 minutes on three occasions.
~Device: Actiwatch-2 (Philips Respironics)"
16022678|NCT02719808|Drug|Tenofovir1|receive tenofovir （300mg/d）from （28±2）weeks of pregnancy to one month after delivery, it is the observational exposure.
16022679|NCT02719808|Drug|Tenofovir2|receive tenofovir （300mg/d）from（28±2）weeks of pregnancy to one month after delivery, it is the observational exposure.
16022680|NCT02719808|Drug|Tenofovir3|receive tenofovir （300mg/d）from （20±2）weeks of pregnancy to one month after delivery, it is the observational exposure.
16022681|NCT02719808|Drug|Tenofovir4|receive tenofovir （300mg/d）from （20±2）weeks of pregnancy to one week after delivery, it is the observational exposure.
16022682|NCT02719795|Drug|Ropivacaine|Local injection of local anesthetic into the fascial spaces
16022683|NCT02719795|Drug|Normal saline|Sodium chloride solution commonly used in clinical which equal to human plasma osmotic pressure.
16022684|NCT02719782|Biological|Biological: TCR-T|Autologous T cells transfected with mRNA encoding HBV antigen-specific TCR
16022685|NCT02719756|Drug|Metformin|Metformin tablets 1000 mg
16022686|NCT02719756|Drug|Dapagliflozin|Dapagliflozin 10 mg tablets
16022687|NCT02719756|Drug|Metformin up-titration|
16022688|NCT02719743|Biological|Influenza A (H5N1) Virus monovalent vaccine (GSK1557484A).|All subjects will receive intramuscularly a two-dose primary series (adjuvanted) at a 21 day interval, and a booster dose (unadjuvanted) at Day 385 of GSK1557484A vaccine.
16022689|NCT02719730|Behavioral|Reimbursement for whole grain purchases|All participants will receive education about whole grain foods. Those in the experimental arm will have a monthly financial incentive for purchases of specific whole grain foods foods during the 12-week study period, whereas the control group will not have a financial incentive for whole grain purchases during the study period.
16022690|NCT02719717|Device|Harmonic Ace+7|Pulmonary artery sealing with Harmonic Ace+7 in VATS lobectomy
16022691|NCT02719704|Behavioral|"MEXA-SE"|"MEXA-SE (move yourself) was structured into three main components: A) Physical fitness: The first component was to increase time in moderate to vigorous physical activity during Physical Education lessons. There were also prompts to help students to engage in increased physical activity during school recess; B) Eating habits: The second component consisted of six sessions (45 minutes per session) designed to promote reflection and positive changes in eating habits and health care (to improve knowledge and eating habits), conducted by nutritionist; C) Body image: The third component was composed of 3 sessions (45 minutes per session) focused on body image satisfaction (Espelho, espelho meu: School based Intervention) conducted by Physical Education researcher."
16022692|NCT02719704|Behavioral|"Espelho, espelho meu"|"Behavioral: Espelho, espelho meu: School based intervention on body image. Body image is worked in four 45 minutes sessions, conducted with a frequency of once a week by a researcher. The topics covered in these sessions refer to: Beauty Standards (media influence and formation of body image), individual qualities (individual and classmates qualities) and selfesteem. These meetings will be held through video, lecture, dynamics, photo sessions and preparation of posters."
16022693|NCT02719691|Drug|Alisertib|Participants will receive Alisertib in the dose-escalation and the dose-expansion part of the study.
16022694|NCT02719691|Drug|MLN0128|Participants will receive MLN0128 in the dose-escalation and the dose-expansion part of the study.
16022695|NCT02719678|Other|General health checks|The intervention group is invited to up to three general health checks over a 10-year period
16022696|NCT02719665|Dietary Supplement|SPM Emulsion, Dose-modality|"Phase 1a Dose-Finding oral SPM administration of increasing dose (15ml, 30ml, and 60ml) by the following schedule:
~Days 1 to 5: 15 ml; Days 6 to 14: Washout, no SPM administration; Days 15 to 19: 30 ml; Days 20-28: Washout, no SPM administration; Days 29-33: 60 ml"
16022697|NCT02719665|Dietary Supplement|SPM Softgel, Dose-Modality|Phase 1b Dose-Finding oral softtel SPM administration of two different doses (2 softgel vs 4 softgel) Days 0 to 5: 2 SPM softgel; Days 6 to 21: Washout, no SPM administration; Days 22 to 26: 4 SPM softgel; Days 27-42: Washout, no SPM administration
16022698|NCT02719665|Dietary Supplement|Placebo Softgel|Days 43-47: 4 Placebo softgel; Day 48-64 Washout
16022699|NCT02719613|Drug|Elotuzumab|Patients will continue to receive treatment with the investigational study drug by intravenous (IV) solution administration at the last dose and schedule received in the previous study.
16022779|NCT02718976|Procedure|Ultrasound guided lumbar plexus block (Shamrock)|
16022700|NCT02719613|Drug|Dexamethasone|Patients will continue to receive treatment with non-investigational study drug by oral tablet administration at the last dose and schedule received in the previous study.
16022701|NCT02719613|Drug|Dexamethasone|Patients will continue to receive treatment with non-investigational study drug by intravenous (IV) solution administration at the last dose and schedule received in the previous study.
16022702|NCT02719613|Drug|Lenalidomide|Patients will continue to receive treatment with non-investigational study drug by oral capsule administration at the last dose and schedule received in the previous study.
16022703|NCT02719613|Drug|Bortezomib|Patients will continue to receive treatment with non-investigational study drug by intravenous (IV) or subcutaneous injection solution administration at the last dose and schedule received in the previous study.
16022704|NCT02719613|Drug|Pomalidomide|Patients will continue to receive treatment with non-investigational study drug by oral capsule administration at the last dose and schedule received in the previous study.
16022705|NCT02719613|Drug|Nivolumab|Patients will continue to receive treatment with the investigational study drug by intravenous (IV) solution administration at the last dose and schedule received in the previous study.
16022706|NCT02719600|Behavioral|Virtual reality|Evaluation of observational motor learning using virtual reality
16022707|NCT02719587|Procedure|Placebo|placebo drug identical except for the fish oil supplement, were only performed at baseline.
16022708|NCT02719587|Procedure|Omega-3|omega-3 PUFAs supplement, were only performed at baseline.
16022709|NCT02719587|Procedure|SRP|Instrumentation was performed until the root surface was considered smooth and clean, according to the operator's clinical judgement.
16022710|NCT02719574|Drug|FT-2102 (olutasidenib)|FT-2102 (olutasidenib) will be supplied as 50 mg or 150 mg capsules and will be administered per the protocol defined frequency and dose level
16022711|NCT02719574|Drug|Azacitidine|azacitidine will be administered per site's standard of care
16022712|NCT02719574|Drug|Cytarabine|low-dose cytarabine will be administered per site's standard of care
16022713|NCT02719561|Behavioral|Fatigue Intervention|The Fatigue Intervention will include education, energy conservation and activity promotion
16022714|NCT02719548|Device|Soft edge oval - Hard oval - Modified PF breast shield|"Treatment order:
~soft-edge oval breast shield
~Hard oval breast shield
~modified PersonalFit breast shield"
16022715|NCT02719548|Device|Modified PF breast shield - Soft edge oval - Hard oval|"modified PersonalFit breast shield
~soft-edge oval breast shield
~Hard oval breast shield"
16022716|NCT02719548|Device|Hard oval - Soft edge oval - Modified PF breast shield|"Hard oval breast shield
~soft-edge oval breast shield
~modified PersonalFit breast shield"
16022717|NCT02719535|Other|Corneal reshaping therapy|Reshaping the corneal curvature from wearing specific designed rigid gas permeable lenses
16022718|NCT02719522|Device|Pipeline™ Flex Embolization Device with Shield Technology™|"Pipeline™ Flex Embolization Device with Shield Technology™ utilizes a phosphorylcholine (PC) surface treatment to the implant combined with the PFED delivery system. The Shield Technology™ surface treatment applied to the implant is an inert polymer material created to mimic the outer membrane of a human red blood cell.
~The Pipeline™ Flex Embolization Device with Shield Technology™ is intended for endovascular embolization of cerebral aneurysms and is designed to be placed across the opening (or 'neck') of a brain aneurysm and redirect blood flow away from the aneurysm, causing the blood within the aneurysm to clot."
16022719|NCT02719509|Procedure|Cardiac Ultrasound|
16022720|NCT02719496|Drug|IBEROGAST|
16022721|NCT02719483|Device|Swiss DolorClast|"Radial (blue) handpiece; one rESWT session per week for three months, with 1500 radial shock waves per session and leg, i.e., a total of 3000 radial shock waves per session or a total of 36.000 radial shock waves within twelve weeks; radial shock waves evenly distributed over the gastrocnemius and soleus muscles; air pressure of the device set at 0.6 bar, resulting in a positive energy flux density (EFD+) of 0.03 mJ/mm2; radial shock waves applied at a frequency of 8 Hz; local or general anesthesia not applied."
16022722|NCT02719483|Procedure|Traditional conservative therapy|Physical therapy, Chinese massage, meridian mediation and muscle stimulation for three months (six days per week, 30 min per type of therapy).
16022723|NCT02719470|Behavioral|MIRT|MIRT consists of a 4-week physical therapy, in a hospital setting, which entails four daily sessions for five days and one hour of physical exercise on the sixth day. The duration of each session is about one hour. The first session consists of a one-to-one session with physical therapist involving muscle stretching. The second session includes aerobic exercises to improve balance and gait using different devices: a stabilometric platform, treadmill plus, crossover and cycloergometer. The third is a session of occupational therapy to improve autonomy in everyday activities. The last session includes one hour of speech therapy
16022724|NCT02719457|Other|6 minute walk test (6 MWT)|6 minute walk test is the standard testing for COPD patients to evaluate their exercise capacity
16022725|NCT02719457|Other|Spot marching test (SMT)|Spot marching test is a new test that developed to evaluate their exercise capacity of COPD patients. This test is alternative method and practical to evaluate exercise capacity. The main benefit of this testing is use a small area to test and movement pattern involve both arm and leg. We expect that SMT may make COPD patient to more dyspnea in a short period of exercise.
16022726|NCT02719431|Drug|Warfarin|
16022727|NCT02719431|Drug|K-877|
16022728|NCT02719418|Drug|Tinzaparin|3500 Unit or 4500 Unit subcutaneous once daily
16022729|NCT02719405|Dietary Supplement|Lactobacillus GG|Lactobacillus GG
16022730|NCT02719405|Dietary Supplement|Extensively Hydrolyzed Casein Formula|Extensively Hydrolyzed Casein Formula
16022731|NCT02719405|Dietary Supplement|Amino Acid Formula|Amino Acid Formula
16022732|NCT02719392|Dietary Supplement|N-acetylcysteine|NAC is an FDA-approved mucolytic (a type of drug used to relieve respiratory difficulties) and is also used for the treatment of acetaminophen toxicity.
16022733|NCT02719392|Drug|Minocycline|Minocycline is an FDA-approved antibiotic commonly used to treat bacterial infections.
16022734|NCT02719392|Other|Placebo|The placebo control is an inactive sugar pill that mimics the active comparators in appearance.
16022735|NCT02719379|Biological|Pneumonococcal Polysaccharide Vaccine 23-valent (PPSV-23)|
16022736|NCT02719366|Device|comfilcon A Extended Range test lens|contact lenses
16022737|NCT02719366|Device|comfilcon A control lens|contact lenses
16102430|NCT02144857|Drug|Apremilast|30mg
16022740|NCT02719340|Procedure|short segment fixation|posterior short-segment decompression and reconstruction (instrumentation on 1 level above and 1 level below the fractured vertebrae with posterolateral fusion)
16022741|NCT02719327|Drug|icosapent ethyl (IPE)|Participants will be randomized in a 1:1 ratio to receive icosapent ethyl 4 g daily vs. matching gel cap placebo
16022742|NCT02719327|Other|gel cap placebo|Participants will be randomized in a 1:1 ratio to receive icosapent ethyl 4 g daily vs. matching gel cap placebo
16022743|NCT02719314|Drug|Glucocorticoid treatment|Glucocorticoid treatment
16022744|NCT02719288|Other|CLARIX® CORD 1K graft|
16022745|NCT02719275|Behavioral|Social Media Monitoring|Retrospective analyses of social media activity prior to crisis.
16022746|NCT02719262|Device|installing ventilation in the workplace|Environmental improvement by installing/ exhaust ventilation (FUDIN SYSTEM ENGINEERING CO.,LTD.)
16022747|NCT02719249|Other|Dried blood spot test|
16022748|NCT02719236|Procedure|direct anterior approach|"The procedure begins by positioning the patient supine on a normal table . Both feet are draped separately to assist with dislocating and proximal femural shaft exposure.The surgical incision begins 2-4 cm lateral to the anterior superior iliac spine of the pelvis . It is then carried distally and laterally for about 8-12 cm. After protecting the lateral femoral cutaneous nerve, the fascia overlying the tensor fascia latae (TFL) is incised, and a plane is then developed between the TFL and sartorius. After coagulating the ascending branch of the lateral femoral circumflex artery, a capsulectomy is performed. Placement of the final acetabular component is facilitated by the use of an offset inserter handle.
~Femoral preparation begins by placing the operative limb in a position of extension, adduction and external rotation to improve the accessibility of the proximal femur.
~Once the final implants are in situ, the hip is reduced and assessed."
16022749|NCT02719236|Procedure|direct lateral approach|"The procedure begins by positioning the patient in the supine decubitus position.
~A longitudinal incision is made extending 3-5 cm proximal and about 5-8 cm distal to the tip of the greater trochanter . The fascia is split at the interval between the TFL and gluteus. The tendon and muscle fibres of the gluteus medius are then visualized and split . The gluteus minimus and joint capsule are split. The surgeon then dislocates the femoral head, and performs a femoral neck osteotomy.
~The acetabulum is prepared .Soft tissue landmarks and reamer positioning relative to the floor are used to verify acetabular version and inclination.
~When preparing the proximal femur, the hip is adducted and externally rotated, with the knee flexed. The femural stem is then press-fitted. Once the final implants are in situ and the hip is reduced, the stability of the construct is assessed."
16022750|NCT02719223|Device|NICaS|The NICaS is a non invasive device for measuring and calculating of hemodynamic parameters including mean arterial pressure (mm/Hg), cardiac index (l/min/m2) and total peripheral resistance (dynes/sec/cm5).
16022751|NCT02719210|Biological|High Volume Plasma Exchange|
16022752|NCT02719210|Drug|Hypertonic 3% saline|
16022753|NCT02719210|Drug|Mannitol|
16022754|NCT02719210|Device|Elective positive pressure ventilation|
16022755|NCT02719197|Drug|AC-083|Hard gelatin capsules for oral administration formulated at a strengths of 1, 10 and 100 mg
16022756|NCT02719197|Drug|Placebo|Placebo capsules matching AC-083 capsules
16022757|NCT02719171|Drug|risankizumab|Risankizumab administered by SC injection
16022758|NCT02719171|Drug|placebo for risankizumab|Placebo for risankizumab administered by SC injection
16022759|NCT02719158|Drug|6 mg ciprofloxacin|Single administration of OTO-201
16022760|NCT02719158|Drug|12 mg ciprofloxacin|Single administration of OTO-201
16022761|NCT02719158|Other|Sham|
16022762|NCT02719132|Drug|Dapagliflozin|Dapagliflozin, 10 mg
16022763|NCT02719132|Drug|Metformin|Metformin, up to 2500 mg
16022764|NCT02719119|Procedure|monthly Endoscopic Variceal Ligation (EVL)|Patients in this group will underwent endoscopic variceal ligation monthly.
16022765|NCT02719119|Procedure|bi-weekly Endoscopic Variceal Ligation (EVL)|Patients in this group will underwent endoscopic variceal ligation bi-weekly.
16022766|NCT02719106|Device|Ultimaster stent|
16022767|NCT02719093|Drug|recombinant FSH|Subcutaneous injection
16022768|NCT02719054|Behavioral|Cognitive behavioral therapy: Alter of negative thinking, positive thinking and social support and psychosocial stimulation: play stimulation and parenting|"A:Cognitive Behavioral Therapy specifically focused on changing thinking style toward positive and not associated with any medication. CBT found to be effective in managing or treating not only depression, also a variety of other conditions-e.g. mood, personality, stress, eating habit, tic etc.
~B: Psycho social stimulation will follow a set of culturally appropriate, semi-structured, child's age appropriate curriculum."
16022769|NCT02719041|Other|Immunohistochemistry staining method|
16022770|NCT02719028|Drug|Antroquinonol|Antroquinonol will be provided as capsules of 50 mg
16022771|NCT02719028|Drug|placebo|The matching placebo will be packaged as Antroquinonol with appearance identical in all aspects, however, don't have the active compound(antroquinonol)
16022772|NCT02719015|Drug|rAd.CD40L|"Dose Escalation Phase Starting Dose: 5x10^10 vp per tumor as an injection directly into 1-3 tumors every 3 weeks. Same tumors injected for each of the 4 injections at week 0, 3, 6 and 9. If the dose well tolerated, the rAd.CD40L escalated to 1x10^11 vp. Subsequently enrolled patients injected at the same dose of 1x10^11 vp. Number of injected sites/tumors increased to two sites/lesions if patients have >/=2 injectable lesions, at the same injection dose of 1x10^10 up to three separate sites/lesions if patients have > 3 injectable lesions.
~Dose Expansion Phase Starting Dose: MTD from Dose Escalation Phase."
16022773|NCT02719015|Drug|Pembrolizumab|Dose Escalation and Expansion Phases: 2 mg/kg by vein every 3 weeks.
16022774|NCT02719002|Device|spectral domain optical coherence tomography C-scan and multifocal electroretinogram|
16022775|NCT02718989|Device|Transcutaneous Electrical Stimulation|TENS transcutaneous electrical stimulation over the back the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
16022776|NCT02718989|Device|10Kilohertz (KHz)|10 KHz transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
16022777|NCT02718989|Device|Sham stimulation|Sham transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
16022778|NCT02718976|Procedure|Ultrasound/MR image fusion guided lumbar plexus block (Shamrock)|
16023639|NCT02712853|Other|Vineland Adaptive Behavior Scale-II Assessment|
16022780|NCT02718976|Drug|Lidocaine-epinephrine added gadoterate meglumine|Perineural injection of 20 ml 2% lidocaine with 0.0005% epinephrine added 1 ml of gadoterate meglumine (0.13 ml) and sodium chloride (NaCl, 0.87 ml). The 1 ml of gadoterate meglumine-NaCl is added to the local anesthetic prior to the perineural injection in order to enhance visualization of the local anesthetic on MRI scanning after the intervention.
16022781|NCT02718963|Device|Synchronized Electrical Stimulation Device|electrical stimulation at muscles which related with deglutition
16022782|NCT02718950|Drug|Liraglutide 3.0 mg|Subjects will use liraglutide 3.0 mg for 2 weeks
16022783|NCT02718937|Drug|BTA-C585 oral capsule|
16022784|NCT02718937|Drug|Matching placebo capsules|
16022785|NCT02718911|Drug|LY3022855|Administered IV
16022786|NCT02718911|Drug|Durvalumab|Administered IV
16022787|NCT02718911|Drug|Tremelimumab|Administered IV
16022788|NCT02718898|Drug|Ixekizumab|Administered SC
16022789|NCT02718898|Drug|Placebo|Administered SC
16022790|NCT02718885|Dietary Supplement|Inulin|Females will ingest 2 doses of 5g/inulin for a total of 10g/inulin/day for four weeks Males will ingest 2 doses of 7.5g/inulin for a total of 15g/inulin/day for four weeks
16022791|NCT02718885|Dietary Supplement|Maltodextrin|Females will ingest 2 doses of 5g/maltodextrin for a total of 10g/maltodextrin/day for four weeks Males will ingest 2 doses of 7.5g/maltodextrin for a total of 15g/maltodextrin/day for four weeks
16022792|NCT02718872|Behavioral|Tobacco cessation online training|"The original course has been developed in the online platform e-oncologia (http://www.e-oncologia.org/en/) based on the in-person courses offered during the last 10 years by the Tobacco Control Unit of the Catalan Institute of Oncology. The theoretical framework underpinning the training program is the Stages of Change Model and the curriculum was developed with the content of numerous meta-analysis and clinical practice guidelines. We created a fully referenced curriculum online, with feedback from an expert advisory group that oriented in the instructional design to ensure the course content was palatable for an online format and aligned with the learning objectives. The final curriculum content of the Brief Intervention for Smoking Cessation Training Program is composed of 4 modules."
16022793|NCT02718859|Biological|NK cells|The pancreatic cancer patients will receive nature killer(NK) cells infusions,qd
16022794|NCT02718859|Procedure|irreversible electroporation (IRE )|The pancreatic cancer patients will receive the therapy of irreversible electroporation (IRE )
16022795|NCT02718846|Drug|Meniace|6 mg of Meniace tablets were administered 3 times per day after meals
16022796|NCT02718846|Drug|Isobide|an initial dosage of 90 mL of Isobide solution was administered orally 3 times a day after meals
16022801|NCT02718820|Drug|Docetaxel|Docetaxel 75mg/m2; q21
16022802|NCT02718820|Drug|Pembrolizumab|Pembrolizumab 200mg, q21
16022803|NCT02718807|Other|RP model explanation and questionnaire|Rapid prototyping models of anatomy will be used to demonstrate an anatomic and medical condition and participants will grade the experience on a questionnaire.
16022804|NCT02718794|Procedure|Simulation training|spend 3 hours for each of 10 nurse anesthetist students with 4 scenarios
16022805|NCT02718794|Procedure|Problem-based learning|spend 3 hours for PBL steps with each of 10 nurse anesthetist students
16022806|NCT02718781|Behavioral|Health talk|Health talk on zero-time exercise.
16022807|NCT02718781|Behavioral|Regular contact with community leaders|Regular contact with community leaders to remind them do zero-time exercise.
16022808|NCT02718781|Device|Handgrip|This is a home-based equipment
16022809|NCT02718755|Drug|Fludarabine|"Induction Phase:
~30 mg/m2 by vein over 15-30 minutes on Days 1 - 5 of a 28 day cycle.
~Consolidation Phase:
~30 mg/m2 by vein over 15-30 minutes on Days 1 - 4 of a 28 day cycle."
16022810|NCT02718755|Drug|Cytarabine|"Induction Phase:
~2 grams/m2 by vein over approximately 2 hours on Days 1 - 5 of a 28 day cycle.
~Consolidation Phase:
~2 grams/m2 by vein over approximately 2 hours on Days 1 - 4 of a 28 day cycle."
16022811|NCT02718755|Drug|Erwinase|"Induction Phase:
~25,000 Units/m2 by vein (or intramuscularly) over 90-120 minutes on Days 1 - 7 of a 28 day cycle.
~Consolidation Phase:
~25,000 Units/m2 by vein (or intramuscularly) over 90-120 minutes every other day on Days 1, 3, 5, 7, 9, 11, 13, 15 of a 28 day cycle."
16022812|NCT02718742|Other|Laboratory Biomarker Analysis|Correlative studies
16022813|NCT02718742|Drug|Paclitaxel Albumin-Stabilized Nanoparticle Formulation|Given IV
16022814|NCT02718742|Other|Quality-of-Life Assessment|Ancillary studies
16022815|NCT02718729|Procedure|Laparoscopic resection for rectal cancer|Formal curative radical laparoscopic rectal resection.
16022816|NCT02718716|Drug|UCB7665|"Intervention Type: Biological/Vaccine
~Pharmaceutical Form: Powder for solution for infusion
~Concentration: 100 mg/ml - Route of Administration:
~Subcutaneous infusion"
16022817|NCT02718703|Device|Blood Glucose Monitoring System.|In vitro diagnostic medical device
16022818|NCT02718690|Device|TENS|TENS transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
16022819|NCT02718690|Device|Sham stimulation|Sham transcutaneous electrical stimulation over back through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
16022820|NCT02718677|Drug|Refacto AF|Observational - Non-Interventional Study
16022821|NCT02718664|Other|Test meal (breakfast)|Standardized test meal, in accordance with high-fat and high-calorie meal as described in the FDA guidance, but ingredients are changed to Dutch standards and ingredients are added that are expected to have the largest effects on dihydrouracil and uracil levels
16022864|NCT02718300|Drug|Parsaclisib|Two recommended oral QD doses of parsaclisib. Once daily doses of parsaclisib will be taken for 8 weeks, followed by once weekly dosing at the same dose level.
16022865|NCT02718300|Drug|Ruxolitinib|The dose of ruxolitinib will be that which the subjects had been taking for at least 8 weeks before the first dose of parsaclisib.
16022866|NCT02718300|Drug|Parsaclisib|20 mg oral QD dose of parsaclisib for 8 weeks. After 8 weeks patients will take either 20 mg once weekly or 5 mg once daily.
16022867|NCT02718300|Drug|Parsaclisib|"2 dose strategies will be compared:
~5 mg parsaclisib beginning on Day 1 until end of treatment.
~20 mg oral QD dose of parsaclisib for 8 weeks; after 8 weeks patients will take 5 mg once daily."
16022822|NCT02718638|Other|physical exercises|Physical exercises were performed during HD sessions, at second hour of HD, three times per week for 3 months. The first exercise was knee extension from 90° to 0°. The patient remained in the 0° position for 5 seconds (an isometric contraction) and then returned to the starting position (90º). 2) The second exercise consisted of a triple flexion followed by extension of the lower limbs. The patient flexed the thigh, knee and ankle (elastic band placed at the level of the metacarpals) followed by a double extension of the thigh and knee. 3) In a co-isometric contraction, the patient performed a leg extension against the ankle-cuff resistance (located under the distal third of the leg at the level of the malleolus) for 10 seconds. 4) The patient performed a unilateral hip joint flexion of the lower limb with the knee extended by rising to their functional limit.
16022823|NCT02718625|Biological|Santyl|Collagenase ointment applied topically
16022824|NCT02718625|Biological|SoloSite®|SOLOSITE is a hydrogel wound dressing with preservatives. It can donate moisture to rehydrate non-viable tissue. It absorbs exudate while retaining its structure in the wound.
16022825|NCT02718599|Drug|terlipressin|Terlipressin will be started at the beginning of surgery as an initial bolus dose of 1 mg over 30 mints(1 mg/50 ml normal saline at a rate of 100 ml/h) followed by a continuous infusion of 2 μg/kg/h(1 mg/50 ml at a rate equal to wt/10 ml per hour) and weaned in the postoperative period over 4 hours.
16022826|NCT02718599|Drug|normal saline|Patients receive 50 ml normal saline at a rate of 100 ml/h followed by a continuous infusion of 50 ml at a rate equal to wt/10 ml per hour and weaned in the postoperative period over 4 hours.
16022827|NCT02718560|Behavioral|Writing|Writing exercise with or without cues for 1 hour per day for 4 days at week for 4 weeks
16022828|NCT02718547|Drug|Combigan|Each Participant will be instructed to instill Combigan eye drops twice daily in one of his eyes (randomly chosen)
16022829|NCT02718534|Behavioral|stroke rehabilitation|Physical rehabilitation exercise between 24 and 48 hours and after 48 hours
16022830|NCT02718521|Procedure|Hydration Combined With Intravenous Infusion of Isosorbide Dinitrate|Before the coronary procedures, investigators used the same 0.9% sodium chloride for hydration conbined with isosorbide dinitrate in all patients 6 hours before angiography and 12 hours after angiography
16022831|NCT02718521|Drug|Visipaque|All study participants received intra-arterial (320 mg I/ml; GE Healthcare)
16022832|NCT02718521|Drug|0.9% sodium chloride ﬂuid administration|
16022833|NCT02718521|Drug|isosorbide dinitrate|
16022834|NCT02718508|Behavioral|eParenting|The second group will continue to receive the same institutional standard care plus the parent will receive an e-parenting skills intervention consisting of: the online parent training program, Parenting Wisely (PW), plus text messaging and a web-based message board.
16022835|NCT02718495|Drug|PTI-428|
16022836|NCT02718495|Drug|Placebo|
16022837|NCT02718482|Drug|Gemcitabine and Docetaxel|Treatment with gemcitabine and docetaxel at day 1 and day 8 n a 3 weeks cycle
16022838|NCT02718482|Drug|Ifosfamide|Treatment arm with high doses of ifosfamide continous infusion for 14 days in a 3 weeks cycle
16022839|NCT02718469|Biological|Ebola Vaccine - low dose|2 x 0.5ml vaccine will be given as intramuscular injections on each of day 1 and day 28
16022840|NCT02718469|Biological|Ebola Vaccine - mid dose|2 x 0.5ml vaccine will be given as intramuscular injections on each of day 1 and day 28
16022841|NCT02718469|Biological|Ebola Vaccine - high dose|2 x 1.0ml vaccine will be given as intramuscular injections on each of day 1 and day 28
16022842|NCT02718469|Biological|Placebo|2 x 0.5ml or 2 x 1.0ml placebo will be given as intramuscular injections on each of day 1 and day 28 depending on cohort
16022843|NCT02718456|Behavioral|Expedited CD4 testing|
16022844|NCT02718456|Behavioral|Supplemental peer counseling|
16022845|NCT02718443|Drug|VXM01|Oral immunotherapy targeting VEGFR2
16022846|NCT02718430|Drug|VXM01|Oral immunotherapy targeting VEGFR2
16022847|NCT02718417|Drug|carboplatin|Given Q3W during chemotherapy phase
16022848|NCT02718417|Drug|paclitaxel|Investigator choice of weekly or Q3W during chemotherapy phase
16022849|NCT02718417|Drug|Avelumab|Given Q3W in combination with carboplatin/paclitaxel during chemotherapy portion
16022850|NCT02718417|Drug|Avelumab|Given as single agent in maintenance portion Q2W
16022851|NCT02718404|Procedure|MR-HIFU Treatment|"The Philips MR-HIFU Sonalleve System integrates a high intensity phased array focused ultrasound transducer with a 3 Tesla Magnetic Resonance (MR) imaging system and electromechanical transducer positioning system to deliver spatially and temporally controlled ultrasound energy and thermal heat to tissues non-invasively.
~At HIFU day (day 0) before treatment patient will be performed a bone lesion MRI and a functional brain MRI."
16022852|NCT02718404|Drug|MR contrast media and medications|During the treatment procedure, an intravenous catheter will deliver MR contrast media and medications (such as sedation and analgesics if required) within the MR room.
16022853|NCT02718404|Procedure|MR images|Following the MR-HIFU procedure, a set of MR images of the target region will be acquired with the use of a MR contrast agent, together with a functional brain MRI.
16022854|NCT02718391|Biological|Autologous Dendritic Cell vaccine|The Dendritic Cells vaccine is given intradermally with 5 injections in sites close to inguinal or axillary lymphnode stations that had not site of previous surgical exeresis; as a rule, vaccine administrations should be performed by alternating injections sites. Two days after each vaccine administration, daily 3 MU Interleukin 2 will be administered subcutaneously for 5 days.
16022855|NCT02718378|Drug|estetrol|
16022856|NCT02718378|Drug|placebo|
16022857|NCT02718365|Procedure|Wedge resection|A wedge resection is the surgical removal of the lung tumor with a small portion of the lung that surrounds the tumor. Hilar and mediastinal lymph nodes should be resected or sampled.
16022858|NCT02718365|Procedure|Segmentectomy|A segmentectomy removes a segment of a lung lobe anatomically, or inclusion of a portion of adjacent segment, but does not remove the whole lung lobe. Hilar and mediastinal lymph nodes should be resected or sampled.
16022859|NCT02718352|Other|Naturalistic Prospective Cohort|Follow subjects through 1 year of naturalistic buprenorphine treatment
16022860|NCT02718339|Behavioral|Intensive counseling|
16022861|NCT02718326|Drug|Intravitreal aflibercept injection [IAI]|
16022862|NCT02718326|Drug|Sham|
16022863|NCT02718300|Drug|Parsaclisib|Up to 3 oral once a day (QD) doses of parsaclisib. Doses will be taken once daily for 8 weeks, followed by once weekly dosing at the same dose level.
16022868|NCT02718287|Behavioral|Home visiting intervention PCCSF (220 clusters)|Low income mothers of children 0-2.5 years of age in the randomized treatment micro-areas will receive home visits by community health workers trained in the PCCSF curriculum in addition to the basic health curriculum. The community health workers are supervised by trained and experienced nurses.
16022869|NCT02718287|Behavioral|Home visiting without PCCSF (220 clusters)|Low income mothers of children 0-2.5 years of age in the randomized control micro-areas will receive home visits by community health workers trained in the standard basic health curriculum (no PCCSF).
16022870|NCT02718274|Device|OraQuick ADVANCE HIV I/II test kits, packaged for self-use (manufactured in Thailand)|Community based distribution of self-tests
16022871|NCT02718274|Other|Home-based initiation of ARVs|Home-based initiation of ARVs by study nurse linked to follow-up at clinic
16022872|NCT02718261|Drug|Pantoprazole|
16022873|NCT02718261|Drug|Saline 0.9% (matching placebo)|
16022874|NCT02718248|Device|CHESS Mobile Health smart phone application|A smart phone application designed to reduce intentional self-harm through problem solving e-therapy.
16022875|NCT02718248|Behavioral|Problem solving therapy|Face to face problem solving therapy every week for six weeks.
16022876|NCT02718235|Other|Overall survival|Observation of overall and disease free survival
16022877|NCT02718222|Device|Post-partum IUD|The PPIUD intervention aims to address the postpartum contraceptive needs of women by training community midwives, health workers, doctors and delivery unit staff in postpartum IUD counselling and insertion.
16022878|NCT02718209|Device|Mid-Infrared Spectroscopy with ATR|
16022879|NCT02718196|Behavioral|Sleep Training smartphone application|Every evening the application provides a list of the planned bedtime activities as well as the recommended bedtime. The steps are 1) positive bedtime routine 2) bedtime fading 3)addressing nocturnal feeding 4) extinction protocol
16022880|NCT02718183|Other|Hydrogen Peroxide 35% (Opalescence Endo - Ultradent, USA)|bleaching teeth gel to intracameral use.
16022881|NCT02718183|Other|carbamide peroxide 37% (Whiteness Superendo, FGM, Brazil).|bleaching teeth gel to intracameral use.
16022882|NCT02718170|Procedure|Buried Intramedullary K-wire Fixation|
16022883|NCT02718170|Procedure|Plate and Screw Fixation|
16022884|NCT02718157|Device|Comparison between GenePOC PCR and Reference Method|Antepartum women swab specimen incubated in Lim Broth will be tested with the GenePOC GBS test on the GenePOC Instrument. The results will be compared to Reference Method defined as incubated Lim broth subcultured onto blood agar plate for observation of a Streptococcus agalactiae strain.
16022885|NCT02718144|Drug|Estetrol|Estetrol formulated in tablets, in escalating doses, will be investigated in patients with estrogen receptor positive (ER+) locally advanced or metastatic breast cancer.
16022888|NCT02718118|Device|Dysport reconstituted at 1.5 mL (0.05 mL/injection)|Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown.
16022889|NCT02718118|Device|Dysport reconstituted at 2.5 mL (0.08 mL/injection)|Subjects treated for moderate to severe (GLSS = 2 or 3) glabellar lines at maximum frown.
16022890|NCT02718105|Genetic|KIR HLAC determinations|We will take blood samples for KIR HLA-C determinations.
16022891|NCT02718092|Device|Plastic Stent|Subjects who are randomized to this arm will receive a plastic stent
16022892|NCT02718092|Device|Axios Fully Covered Self Expanding Metal Stent|Subjects who are randomized to this arm will receive the Axios FCEMS
16022893|NCT02718079|Biological|Plasma Exchange|
16022894|NCT02718079|Other|Management of cerebral edema/intracranial hypertension:|
16022895|NCT02718079|Other|Transfer to Intensive Care Unit|
16022896|NCT02718079|Drug|Prophylactic Antibiotics|
16022897|NCT02718079|Other|Intubation of trachea|
16022898|NCT02718079|Other|Administration of mannitol or 3% saline for severe elevation of Intra Cranial Pressure|
16022899|NCT02718079|Other|Volume Replacement|
16022900|NCT02718079|Other|Pressor Support|
16022901|NCT02718079|Drug|N-acetyl-L-cysteine|
16022902|NCT02718079|Other|Correction of metabolic parameters|
16022903|NCT02718079|Dietary Supplement|Correction of nutrition|
16022904|NCT02718066|Drug|HBI-8000 in combination with nivolumab|"Phase 1b: HBI-8000, orally, twice a week, dose escalation 20mg, 30mg, 40mg; in combination with nivolumab 240mg intravenous infusion every 2 weeks.
~Phase 2: HBI-8000 MTD or 40mg; in combination with nivolumab in accordance with the manufacturer package insert and institution's prescribing practice."
16022905|NCT02718053|Other|L-stiff|spasticity measurement with Lokomat
16022906|NCT02718053|Other|Ashworth|spasticity measurement with Ashworth scale
16022907|NCT02718040|Device|Emervel Classic and/or Deep Treatment Group|"Severity of Wrinkle Severity treated by product type:
~Emervel Classic:
~Nasolabial Folds (NLFs): Wrinkle Severity Rating Scale (WSRS) = 2/2, 2/3 or 3/3; Marionette Lines (MLs): Wrinkle Assessment Scale (WAS) = 2/2, 2/3 or 3/3
~Emervel Deep Nasolabial Folds (NLFs): Wrinkle Severity Rating Scale (WSRS) = 3/3, 3/4 or 4/4; Marionette Lines (MLs): Wrinkle Assessment Scale (WAS) = 3/3, 3/4 or 4/4
~Both products may be used in the same subject, but only in different anatomic locations. The same study product should be used within the same wrinkle or fold type (e.g., left and right NLFs treated with the same product)"
16022908|NCT02718014|Other|scaling and root planing (srp)|
16022910|NCT02717988|Drug|SKI-O-703 capsule|SKI-O-703 25 mg capsule or 200 mg capsule without excipient
16022911|NCT02717988|Drug|Placebo capsule|Placebo 180 mg capsule filled with microcrystalline cellulose
16022912|NCT02717975|Procedure|Use of catheter valve before 'trial removal of catheter'|The investigators are comparing two groups of patients (Group A) Trial removal of urinary catheter in patients with urinary retention after applying catheter valve and closing it 3-4 hours before catheter removal.
16022945|NCT02717754|Drug|Oseltamivir|Oseltamivir will be administered at 100 or 200 mg intravenous BID for 5 days.
16022946|NCT02717754|Drug|Placebo|Oseltamivir matched placebo will be administered intravenous for 5 days.
16022913|NCT02717975|Procedure|Trial removal of catheter in patients with urinary retention|The investigators are comparing two groups of patients (Group B) Trial removal of urinary catheter in patients with urinary retention without using catheter valve - 'Traditional method'
16022914|NCT02717962|Drug|VAL-083, Dianhydrogalactitol|The dosing regimen for patients will be VAL-083 (30 mg/m2) administered IV for 3 consecutive days at the beginning of every 21-day cycle. Patients will continue to receive VAL 083, for up to 12, 21-day treatment cycles or until they fulfill one of the criteria for study discontinuation.
16022915|NCT02717949|Drug|sofosbuvir/ledipasvir|sofosbuvir ledipasvir fixed dose combination given once a day by mouth
16022916|NCT02717949|Drug|sofosbuvir|sofosbuvir 400 mg given one a daily orally and weight-based ribavirin given twice a day orally
16022917|NCT02717949|Drug|Ribavirin|ribavirin 1200 mg given orally in divided dose for those >75kg and 1000 mg in divided dose for those <75 kg.
16022918|NCT02717936|Procedure|Immunohistochemistry using Pancytokeratin Staining|
16022919|NCT02717923|Other|maintenance treatment with capecitabine plus cetuximab|Using a maintenance treatment strategy of capecitabine plus cetuximab as a treatment option in mCRC after first-line 5-FU-based chemotherapy plus cetuximab
16022920|NCT02717910|Behavioral|Health game|Health game intervention consists of 20 minutes guided training session with the health game at school and 2 weeks free usage of the health game via own smart phone or tablet computer during free time. The health game includes textual information about the consequences of tobacco use, but also visualized elements that aim at supporting understanding of the information, and motivation and ability to use the information in daily life situations. The visualized content is presented in a format of a game including tasks, rules, goals, rewards and opponents. There are also sound effects and background music included in the game.
16022921|NCT02717910|Behavioral|Web page|Web page intervention consists of 20 minutes guided training session with the web page at school and 2 weeks free usage of the web page via own smart phone or tablet computer during free time. The web page includes textual information about the consequences of tobacco use, but also visualized elements that aim at supporting understanding of the information, and motivation and ability to use the information in daily life situations. The visualized elements are presented with pictures and video clips. These visualized elements do NOT contain game elements (NO activating tasks, rules, goals, rewards or opponents). The video clips contain sound effects, but no background music.
16022922|NCT02717897|Other|No intervention|This study is not interventional
16022923|NCT02717884|Drug|tranylcypromine|"TCP p.o., daily either 20, 40**, 60**, 80** mg/day, (28d/cycle)
~**TCP doses will be slowly increased during cycle 1 and slowly decreased at end of treatment (for details see study protocol)"
16022924|NCT02717884|Drug|all-trans retinoic acid|45mg/m2 (days 10-28), CAVE: ATRA will be administered without interruption until inclusively cycle 3. At the beginning of the cycle 4 a nine-day break corresponding to the first nine days of the AraC treatment will be performed, thereafter the ATRA-therapy will be continued with a nine-day interruption every fourth cycle. That means that the therapy in cycles 1, 4, 7, 10, 13 etc. In other cycles ATRA will be given without interruption
16022925|NCT02717884|Drug|cytarabine|40mg s.c. (days 1-10)
16022926|NCT02717871|Device|PACK-CXL|"Local anesthesia
~- Oxybuprocaine or Tetracaine, 1 drop each, applied together, every 3 minutes, total of 3 times
~Abrasio - Abrasio: 1 mm around the borders of the infiltrate/ulcer
~Corneal scrape
~Hypo-osmolaric riboflavin solution
~- Apply one drop every 2 minutes for 20 minutes
~UV-A irradiation
~3 mW/cm2 for 30 minutes or 9 mW/cm2 for 10 minutes, 18 mW/cm2 for 5 minutes, 30 mW/cm2 for 3 minutes all allowed (see paper Richoz et al)
~Treatment diameter: use a irradiation diameter of 6 to 8 mm, keep the infiltrate/ulcus centered.
~Additional postoperative treatment
~Homatropin or Scopolamin, if anterior chamber reaction
~Systemic NSAID/NSAR, if substantial pain
~Do not use: topical or systemic steroids, topical NSAID/NSAR, paracetamol, vitamin A ointment, patching"
16022927|NCT02717871|Drug|Cefazolin in combination with either tobramycin or gentamicin|"Control arm consists of standard topical antimicrobial therapy recommended for the treatment of microbial keratitis by the American Academy of Ophthalmology.
~Initial empiric topical antibiotic therapy (eye drops or ocular ointment):
~1a. Cefazolin (50mg/ml) in combination with either tobramycin (9-14mg/ml) or gentamicin (9-14mg/ml)."
16022928|NCT02717871|Drug|Cycloplegic agents (cyclopentolate 1% eye drops)|Cycloplegic agents (cyclopentolate 1% eye drops): to decrease pain and synechia risk is at the physician discretion.
16022929|NCT02717871|Drug|Fluoroquinolones (Besifloxacin ; ciprofloxacin ; gatifloxacin ; levofloxacin ; moxifloxacin ; ofloxacin )|Fluoroquinolones (Besifloxacin 6 mg/ml; ciprofloxacin 3 mg/ml; gatifloxacin 3 mg/ml; levofloxacin 15 mg/ml; moxifloxacin 5 mg/ml; ofloxacin 3 mg/ml)
16022930|NCT02717871|Drug|Corticosteroids (prednisolone acetate 0.5% or 1% eye drops)|Corticosteroids (prednisolone acetate 0.5% or 1% eye drops): use of corticosteroids for patients included in the study only after complete closure of the epithelium
16022931|NCT02717858|Drug|liraglutide|Injected s.c./subcutaneously (under the skin) Dose escalation period starting with liraglutide 0.6 mg per day and escalated with weekly increments of 0.6 mg until the target dose 3.0 mg is reached.
16022932|NCT02717858|Drug|placebo|Injected s.c./subcutaneously (under the skin) once daily.
16022933|NCT02717845|Device|Ellipse|diagnostic CT scan imaging
16022934|NCT02717845|Device|Tomofix|diagnostic CT scan imaging
16022935|NCT02717832|Drug|hyperinsulinemic-euglycemic clamp|
16022936|NCT02717819|Dietary Supplement|Protein|Daily intake of supplement
16022937|NCT02717819|Dietary Supplement|Placebo|Daily intake of supplement
16022938|NCT02717819|Other|Resistance training|Resistance training (offered daily while hospitalized, and encouragement of 4 x/week as self-training after discharge)
16022939|NCT02717819|Dietary Supplement|Vitamin D|Aiming at a dose of 20 ug/day. 20 ug/day will be handed out to study participants who do not get vitamin D supplements from the hospital while admitted and to those who are not already taking vitamin D supplements themselfes e.g. as part of a combination tablet.
16022940|NCT02717806|Behavioral|PATHway|Patients will use the PATHway platform for 6 months
16022941|NCT02717793|Other|Strength testing|"isometric muscle strength
~1RM measurement of muscle strength"
16022942|NCT02717780|Drug|Fentanyl and sevoflurane|
16022943|NCT02717780|Drug|Remifentanil and desflurane|
16022944|NCT02717767|Other|Autofluorescence of white corpuscle|Measure of auto-fluorescence of white corpuscles cells harvested from tracheal aspirate and/or bronchoalveolar lavages
16022947|NCT02717741|Drug|tafetinib|
16022948|NCT02717728|Procedure|Drug group Fascia iliaca nerve block|"Device: Fascia Iliaca Catheter. Placement: Site prepared using aseptic technique.
~Device: Portable ultrasound: Localization of target site. Aseptic preparation of probe with sterile sheath. 18g x 10mm echogenic enhanced needle, 20G catheter inserted 3 cm beyond needle tip.
~Drug: Local anesthetic bolus: Ropivacaine 0.2% 0.5 ml/kg total in divided doses Device: Dressing Drug: Infusion of Ropivacaine 0.1%, rate: 0.3 ml/kg/hr; to start within the first hour after the block is placed. Infusion will be maintained for 24hs."
16022949|NCT02717728|Procedure|Control group sham nerve block|"Device: Fascia Iliaca Catheter placement: Site prepared using aseptic technique.
~Device: portable ultrasound: Localization of target site. Aseptic preparation of probe with sterile sheath.
~Device: Dressing
~Drug: Infusion of Ropivacaine 0.1%, rate: 0.3 ml/kg/hr; to start within the first hour after the block is placed. Infusion will be maintained for 24hs."
16022950|NCT02717715|Behavioral|Home base stroke rehabilitation|The intervention consists of physiotherapy exercises targeting functional and physical capacity.
16022951|NCT02717689|Other|Biomarker based adjustment of corticosteroid dose|The subject's corticosteroid dose will be adjusted based upon biomarker results (FeNO, eosinophils and periostin)
16022952|NCT02717676|Procedure|Episiotomy|episiotomy will be done after crowning of the fetal head
16022957|NCT02717650|Other|A-STEP|"Study A) Study A) Development of new exercise test protocol and Observational Feasibility/Safety Study (no comparator).
~Feasibility/safety of a newly designed, incremental, maximal, standardised step test in adults with Cystic Fibrosis."
16022958|NCT02717650|Other|A-STEP (New Protocol)|Study B) Validation Study (random allocation of test order). Validity of an incremental, maximal, standardised incremental step test with breath-by-breath gas analysis using portable metabolic measurement equipment against CPET.
16022959|NCT02717650|Other|Comparator: CPET cycle ergometer (Gold Standard)|"Study B) Validation study (random allocation of test order) Gold standard CPET. An incremental, maximal standardised cycle ergometer exercise test (performed as per published protocol) using portable metabolic measurement equipment."
16022960|NCT02717624|Drug|Acalabrutinib in combination with BR|
16022961|NCT02717624|Drug|Acalabrutinib in combination with VR|
16022962|NCT02717611|Drug|ACP-196 (acalabrutinib)|ACP-196 100 mg to be administered orally (PO) twice a day BID.
16022963|NCT02717598|Procedure|cold snare polypectomy|CSP was performed by using a disposable oval snare with a diameter of 10 mm under gentle suction to reduce colon wall tension. The tip of the endoscope was deflected toward the polyp base to ensnare 1 to 2 mm of normal mucosa surrounding the polyp. Afterward, additional EMR was performed at the polypectomy site to evaluate for the presence of residual polyp tissue,including an additional 1 to 2 mm clear margin, was resected by the snare and Endocut current after submucosal injection of a mixed solution.In the event that no tissue could be removed or if EMR failed to get in situ mucosal specimens. At least four cold biopsies using forceps on the remaining margins were obtained.After each procedure, the polypectomy site was observed for 30 seconds to confirm the absence of immediate bleeding.Cross-sections of the EMR specimens were collected at 1-mm intervals.
16022964|NCT02717598|Procedure|hot snare polypectomy|HSP, which is using electrocoagulation on the basis of using cold snare.After HSP, another independent endoscopic surgeon judged whether the endoscopic eradication was successful. Afterward, additional EMR was performed at the polypectomy site to evaluate for the presence of residual polyp tissue,including an additional 1 to 2 mm clear margin, was resected by the snare and Endocut current after submucosal injection of a mixed solution.In the event that no tissue could be removed or if EMR failed to get in situ mucosal specimens. At least four cold biopsies using forceps on the remaining margins were obtained.After each procedure, the polypectomy site was observed for 30 seconds to confirm the absence of immediate bleeding, the specimens were retrieved and stored in formalin. Cross-sections of the EMR specimens were collected at 1-mm intervals; accurate tissue section of the marked site was ensured.
16022965|NCT02717585|Device|Continuous Positive Airway Pressure Therapy (CPAP)|Continuous Positive Airway Pressure Therapy (CPAP) consists of a mask, fitted to the patient's face and hooked to a machine that generates positive pressure at the end of expiration to abolish obstructive apneic episodes during sleep.
16022966|NCT02717572|Radiation|Fludeoxyglucose F 18|
16022967|NCT02717572|Device|Positron Emission Tomography|
16022968|NCT02717572|Device|Computerized Tomography|
16022969|NCT02717572|Device|Magnetic Resonance Imaging|
16022970|NCT02717546|Device|Zimmer MotionLoc Screw|Patients with distal tibia fractures (AO 43-A and C) requiring surgical intervention eligible for locked plating.
16022971|NCT02717533|Other|dry weight adjustment|dry weight change to match ideal blood volume obtained by blood volume measurement.
16022972|NCT02717520|Device|EQUIA Forte and Tetric EvoCeram|"GC cavity conditioner (20% polyacrylic acid) will be applied for 10 sec, rinsed and the cavity will be dried with a cotton pellet. EQUIA Forte will be prepared according to the manufacturer instructions, applied in bulk and compacted with a condenser. The self-curing restoration will be finished after hardening, approximately 2 min 30 sec after the start of the capsule mixing, using Arkansas stones under water cooling. EQUIA Forte Coat will be applied to the surfaces and light cured with D-light for 20 sec.
~Enamel will be etched with 37% orthophosphoric acid for 10 sec. After the acid gel removal, the cavity will be carefully dried. The adhesive (Adhese 2, Ivoclar Vivadent) will be applied and light cured with D-light (1200 mW/cm2, slow mode) for 10 sec. The composite resin will be placed with an incremental technique (2 mm layers), and light-cured with D-light (20 sec). Restorations will be finished with fine diamond and carbide burs in slow and high-speed hand-piece and polished."
16022973|NCT02717507|Drug|Carvedilol|Given PO
16022974|NCT02717507|Other|Laboratory Biomarker Analysis|Correlative studies
16022975|NCT02717507|Other|Pharmacogenomic Study|Correlative studies
16022976|NCT02717507|Other|Pharmacological Study|Correlative studies
16022977|NCT02717507|Other|Placebo Administration|Given PO
16022978|NCT02717507|Other|Quality-of-Life Assessment|Ancillary studies
16022979|NCT02717507|Other|Questionnaire Administration|Ancillary studies
16022980|NCT02717494|Biological|PPV-23|PPV-23 was a polysaccharide PNC vaccine, licensed in Brazil, directed against 23 serotypes.
16022981|NCT02717494|Biological|PCV-10|PCV-10 was a conjugate PNC vaccine, licensed in Brazil, directed against 10 serotypes.
16022982|NCT02717494|Other|NaCl|NaCl was the placebo for the study against which the two vaccines were compared during pregnancy.
16022983|NCT02717481|Device|US-CT Fusion examination|Patients will undergo an US examination using an US device with US-CT Fusion capabilities.
16022984|NCT02717468|Device|Cardiac output and stroke ejection volume monitoring with arterial waveform analysis in the digital artery (ClearSight®)|
16022985|NCT02717468|Device|Cardiac output and stroke ejection volume monitoring with arterial waveform analysis in the radial artery (Pulsioflex®).|
16022986|NCT02717455|Drug|LBH589|"STRATUM 1: Recurrent/progressive DIPG. Panobinostat will be given every other day, 3 times/ week, p.o. preferably on Mon/Wed/Fri, for three weeks, followed by one week off of therapy. Three weeks of therapy plus the one week rest period (4 weeks) will constitute one course. Treatment will continue for up to 26 courses (about 2 years) barring progressive disease or unacceptable toxicity.
~STRATUM 2: Non-progressed DIPG. Panobinostat will be given every other day, 3 times/week, every other week p.o. preferably on Mon/Wed/Fri. Four weeks will constitute one course. Treatment will continue for up to 26 courses (about 2 years) unless the patient experiences progressive disease, unacceptable toxicity or any of the off-treatment criteria."
16022987|NCT02717442|Drug|OTO-104|Single intratympanic injection of 12 mg OTO-104
16022988|NCT02717442|Drug|Placebo|Single intratympanic injection of placebo
16022989|NCT02717429|Behavioral|Mindfulness Meditation|The mindfulness meditation-training program is closely modeled after the 8-week mindfulness based stress reduction protocol developed by Dr. Jon Kabat-Zinn. The briefer four weeks of MMT involve the practice of concentrative attention, where different objects are used as the focus of meditative practices. For example, for the first two weeks, the investigators use breath as an anchor for attention. With repeated practices, the objects of sensations, emotions, and thought processes are introduced.
16022990|NCT02717429|Behavioral|Computerized Cognitive Training|The control group, which will be used to compare the effects of mindfulness training on emotional and cognitive functioning of MS patients, will comprise of a cognitive training group, which will provide an attentional-training based approach. In this group, the focus will be to provide the individuals with cognitive training tasks to complete that have been shown to improve attentional ability. The investigators will also discuss relevant MS-related material on cognitive deficits during these courses.
16022991|NCT02717416|Device|Endo-Clot|After epinephine injection therapy, Endo-Clot is applied immediately onto the bleeding lesion. A total of 2 g of AMP® particle powder will be sprayed onto the bleeding lesion by a catheter inserted through a working channel of the endoscope under continuous air flow.
16022992|NCT02717416|Device|hemoclip or electrical coagulation|After epinephrine injection therapy, hemoclip (HX-610-135, Olympus, Japan) will be applied onto the bleeding lesions. The number of hemoclip will be decided by endoscopist. Electrical coagulation will be applied onto the bleeding lesions.
16022993|NCT02717403|Behavioral|Questionnaires|Participants complete a self response electronic questionnaire at baseline, and at three and six months.
16022994|NCT02717403|Behavioral|Facebook|Participant accesses Facebook page regarding rheumatoid arthritis.
16022995|NCT02717403|Behavioral|Educational Website|Participant accesses Educational Website on the internet about rheumatoid arthritis.
16022996|NCT02717403|Behavioral|Phone Interview|Research staff calls participant to obtain feedback about the websites. The interview will last approximately 30 minutes.
16022997|NCT02717390|Behavioral|Bright By Three (BB3)|The purpose of the BB3 intervention (annual home visit, written materials, and BB3 mobile application 'app') is to increase parental talking, reading, playing, and praise (TRPP) behaviors and improves children's social-emotional and language development at ages 2, 3, and 4 years.
16022998|NCT02717390|Behavioral|Texts for Child Safety (TCS)|The purpose of the injury prevention arm is to reduce the prevalence of safety hazards in the home and car environments, decrease the number of self-reported and medically-attended injuries among children, and increase caregiver's self-reported safety behaviors and knowledge of child safety. The Investigators will compare the results of our tailored child safety intervention (Texts for Child Safety [TCS]) among participants in the injury prevention arm with those randomized to the BB3 arm.
16022999|NCT02717377|Behavioral|physical activity|
16023000|NCT02717364|Drug|Yervoy|
16023001|NCT02717351|Drug|Coppertone (BAY 987517)|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.(Formulation- SR16-07)
16023002|NCT02717338|Behavioral|Competence|Participants will be assigned to review our donor coping website that combines text, videos, and interactive features to directly address common donor fears and to offer advice on empirically-validated strategies to reduce fear, pain, and syncopal reactions.
16023003|NCT02717338|Behavioral|Autonomy|Participants will be assigned to receive a brief telephone interview that we have developed that encourages blood donors to reflect upon their unique motivations for giving and how the act of donating is consistent with their broader life goals and values.
16023004|NCT02717338|Behavioral|Relatedness|Participants will be asked to join a closed Facebook group for one month. The group encourages participants to discuss their experiences with blood donation, including such things as posting images of their donations and/or reasons for donating. Posts will be designed to encourage social interaction around donation experiences, identity formation and group affiliation.
16023005|NCT02717325|Drug|Coppertone (BAY987517)|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.(Formulation- SR16-08)
16023006|NCT02717299|Device|Verasense|Verasense will collect balancing data on all patients in this trial.
16023007|NCT02717286|Procedure|restorative|It was performed direct restoration using two kinds of adhesive system (total-etching adhesive and self-etching adhesive)
16023008|NCT02717273|Drug|standard|peri-operative antibiotic regimen only
16023009|NCT02717273|Drug|extended|extended three-day course of antibiotics
16023010|NCT02717273|Other|liver transplant|orthotopic liver transplantation
16023061|NCT02716974|Procedure|Prostatectomy|Removal of the entire prostate gland, plus some surrounding tissue.
16023062|NCT02716974|Radiation|Radiation|5 high dose radiation treatments to the metastatic (tumor has spread to other parts of the body) sites.
16023011|NCT02717260|Device|transcranial random noise stimulation (tRNS) (Starstim)|subjects are stimulated 3 times in a day by transcranial random noise stimulation (tRNS) (Starstim). each 20 minutes stimulation are separated by a period of at least 30 minutes. before and after each stimulation, inhibition is evaluated by cognitive tests: go nogo test, stroop test, Hayling test and by the BIS 10 scale. During the stimulation, subjects compleat the STAXI and STAI scales. Cognitive tests are repeated 24 hours and 8 days after the stimulation to evaluate duration of the effect. Possible side effects will be notified throughout the protocol.
16023012|NCT02717247|Device|Active tRNS|"The intervention consists in active tRNS stimulation with cathode above the left dorsolateral prefrontal cortex (DLPFC) which corresponds to the F3 location given by the 10-20 system. Anode is above the right dorsolateral prefrontal cortex (F4).
~100Hz-650Hz, 2mA, 30min, twice daily, 5 days"
16023013|NCT02717247|Device|Sham tRNS|The intervention consists in placebo or sham tRNS stimulation electrode are above F3 and F4. Voltage will be ramped at the begin and end of a stimulation for 30 seconds. Placebo stimulation will consist of just applying the ramps at the begin and end of the stimulation.
16023014|NCT02717234|Other|Oral Nutrition Supplement|Oral nutrition supplement intended for consumption at 3 servings per day
16023015|NCT02717221|Other|18F-MPG|N-(3-chloro-4-fluorophenyl)-7-(2-(2-(2-(2-[18F] fluoroethoxy) ethoxy) ethoxy) ethoxy)-6-methoxyquinazolin-4-amine (18F-MPG)
16023016|NCT02717208|Biological|HL036|
16023017|NCT02717208|Biological|Vehicle|
16023018|NCT02717195|Drug|Risperidone|4-6 mg/day, encapsulated tablets, orally
16023019|NCT02717195|Drug|Olanzapine|15-20 mg/day, encapsulated tablets, orally
16023020|NCT02717195|Drug|Lu AF35700|10 mg/day, encapsulated tablets, orally
16023021|NCT02717195|Drug|Lu AF35700|20 mg/day, encapsulated tablets, orally
16023022|NCT02717182|Other|interviews|interviews
16023023|NCT02717169|Device|Biometrical tracker|35 participants are wearing a activity, sleep and heart rate tracker day and night time over a period of 5 month. The wrist watch is equipped with accelerometer, heart rate monitor using oximetry sensor, 3 led lights and vibrating alarm. The tracker is connected over Bluetooth with a smartphone App displaying the measured values and permitting to show different statistics related to amount of steps, sleep duration and heart rate over days, weeks and months.
16023024|NCT02717156|Procedure|Computed Tomography|Correlative studies
16023025|NCT02717156|Other|Laboratory Biomarker Analysis|Correlative studies
16023026|NCT02717156|Biological|Pembrolizumab|Given IV
16023027|NCT02717156|Procedure|Positron Emission Tomography|Correlative studies
16023028|NCT02717156|Biological|Recombinant EphB4-HSA Fusion Protein|Given IV
16023029|NCT02717130|Drug|Aripiprazole|
16023030|NCT02717117|Other|Soup meal|Soup meal as above
16023031|NCT02717091|Drug|FOLFIRINOX|
16023032|NCT02717091|Drug|gemcitabine + nab-paclitaxel|
16023033|NCT02717078|Other|Diet Therapy|The intervention for both study groups will be a change in diet.
16023034|NCT02717065|Other|Tone|Band-limited white noise stimulus or frequency-matched tone presented at a comfortable loudness level via headphones or earphones.
16023035|NCT02717065|Other|Video|Silent video recording of a person speaking or a still face with an expanding circle over the mouth presented on a computer or tablet screen.
16023036|NCT02717052|Drug|(S)-ketamine (Main study)|"Ketanest® S (Esketaminhydrochlorid) 5mg/ml and 25mg/ml ampoules; Actavis Italy S.P.A./Pfizer Corporation Austria GmbH
~Dosis: 0.25mg/kg bodyweight i.v. over 40 Minutes (ending 10 minutes before PET measurement)"
16023037|NCT02717052|Drug|(S)-ketamine (Pilot II)|"Ketanest® S (Esketaminhydrochlorid) 5mg/ml and 25mg/ml ampoules; Actavis Italy S.P.A./Pfizer Corporation Austria GmbH
~Dosis: 0.10mg/kg bodyweight i.v. bolus applied over 5 minutes (starting 15 minutes before PET measurement) and continuous infusion of 0.30mg/kg bodyweight i.v. applied over the course of 130 minutes."
16023038|NCT02717052|Drug|(R,S)-ketamine (Pilot II)|"Ketamin-hameln (Ketaminhydrochlorid) 50mg/ml Ampullen; Hameln Pharma Plus GmbH; Sanova Pharma
~Dosis: 0.20mg/kg bodyweight i.v. bolus applied over 5 minutes (starting 15 minutes before PET measurement) and continuous infusion of 0.60mg/kg bodyweight applied i.v. over the course of 130 minutes."
16023039|NCT02717052|Drug|Placebo|0.9% saline solution i.v. over 40 Minutes (ending 10 minutes before PET measurement)
16023040|NCT02717052|Other|PILOT Study II: PET1|[11C]DASB PET
16023041|NCT02717052|Other|PILOT Study II: PET2|[11C]DASB PET
16023042|NCT02717052|Other|Main Study: PET1|[11C]DASB PET
16023043|NCT02717052|Other|Main Study: PET2|[11C]DASB PET
16023044|NCT02717052|Other|PILOT Study I: PET1|[11C]DASB PET
16023045|NCT02717052|Other|PILOT Study I: PET2|[11C]DASB PET
16023046|NCT02717052|Drug|(R,S)-ketamine (Pilot I)|"Ketamin-hameln (Ketaminhydrochlorid) 50mg/ml Ampullen; Hameln Pharma Plus GmbH; Sanova Pharma
~Dosis: 0.50mg/kg bodyweight i.v. over 40 Minutes (ending 10 minutes before PET measurement)"
16023047|NCT02717052|Drug|(R,S)-ketamine (Pilot III)|"Ketamin-hameln (Ketaminhydrochlorid) 50mg/ml Ampullen; Hameln Pharma Plus GmbH; Sanova Pharma
~Dosis: 0.80mg/kg bodyweight i.v. over 50"
16023048|NCT02717052|Other|PILOT Study III: PET1|[11C]DASB PET
16023049|NCT02717052|Other|PILOT Study III: PET2|[11C]DASB PET
16023050|NCT02717039|Procedure|Blood Draw|A one time blood draw of 150 milliliters will be performed using a vein in the participants arm. Existing venous access will be used for the blood draw in preference of new venipuncture.
16023051|NCT02717026|Device|Optical coherence tomography|Sections including the retinal vasculature will be taken.
16023052|NCT02717026|Device|Fluorescein angiography|Video fluorescein angiography from one eye of each subject will be performed
16023053|NCT02717026|Device|Fundus photography|30 and 50 degree fundus images
16023054|NCT02717013|Dietary Supplement|Placebo|Placebo capsules containing calcium lactate similar to the HMB capsules.
16023055|NCT02717013|Dietary Supplement|HMB|HMB capsules supplying 3 grams per day of calcium beta-hydroxyl-beta-methylbutyrate.
16023056|NCT02716987|Drug|TAK-831|TAK-831 oral suspension.
16023057|NCT02716987|Drug|[18F]PGM299|[18F]PGM299 injection
16023058|NCT02716974|Drug|Leuprolide Acetate|22.5mg by intramuscular (IM) injection every 3 months
16023059|NCT02716974|Drug|Bicalutamide|bicalutamide (Casodex) 50mg by mouth daily
16023060|NCT02716974|Drug|Docetaxel|Docetaxel (taxotere) 75 mg/m2 IV will be given on day 1 every 3 weeks, up to 6 cycles.
16023063|NCT02716961|Drug|Gemcitabine, cisplatin|Patients who were pathologically confirmed as moderate-high risk NMIBC. Epirubicin was immediately instilled in 24h after TURBT and regularly conducted for a year. GC scheme systematic chemotherapy was underwent 5 days after TURBT, which contained gemcitabine 1000-1200mg/m2. Cisplatin (70mg/m2) was intravenous dripped in the first and 8th day after TURBT. Intravenous rehydration was conducted in the second day.
16023064|NCT02716948|Other|Laboratory Biomarker Analysis|Correlative studies
16023065|NCT02716948|Biological|Nivolumab|Given IV
16023066|NCT02716948|Radiation|Stereotactic Radiosurgery|Undergo stereotactic radiosurgery
16023067|NCT02716935|Dietary Supplement|Fortified lipid based nutrient supplement|6 months intervention: participant will take a daily dose of 20g supplement. The product contains 3 g of a mixture (1:1) of inulin and fructan-oligosaccharide
16023068|NCT02716935|Dietary Supplement|lipid based nutrient supplement|Dietary Supplement: lipid based nutrient supplement (Nutributter) 6 months intervention: participant will take a daily dose of 20g supplement.
16023069|NCT02716922|Procedure|Cervical cerclage|Cerclage is a circumferential stitch of non-absorbable suture placed around the cervix Cerclage type: McDonald Cerclage Suture: Permanent monofilament Pericerclage antibiotics: none Pericerclage tocolytics: none Bed rest: not recommended (in both groups)
16023070|NCT02716909|Device|Cervical pessary|The cervical pessary is a silicone device that has been used to prevent SPTB Pessary will be placed between 18 and 23 6/7 weeks gestation, and will be removed during the 37th week of pregnancy (or earlier, if indicated)
16023071|NCT02716896|Radiation|Radiation and chemoradiation|Radiation and chemotherapy will be administered concurrently to those who are randomized to this group.
16023072|NCT02716896|Procedure|Radical cystectomy|Radical cystectomy will be performed on those who are randomized to this group.
16023073|NCT02716883|Procedure|AMT|"The AM was trimmed in two layers to fit the corneal ulcer and was placed with its epithelium (basement membrane) side up, secured with 10/0 nylon sutures, supported by a therapeutic contact lens. The operated eye was patched for 2 h, and then administration of the medical treatment agents was resumed.
~In patients in the case group AMT was performed during days 2-5 of antibiotic therapy when initial clinical response to the treatment was observed."
16023074|NCT02716870|Other|Fructose-containing Sugars|An intervention in which calories from fructose-containing sugars are substituted, added, or subtracted in the diet
16023075|NCT02716857|Drug|Oxycodone extended-release|
16023076|NCT02716857|Drug|Placebo of oxycodone extended-release|
16023077|NCT02716844|Other|Exercise|Clinical Pilates exercise were given for 6 weeks, 3 days in a week
16023078|NCT02716831|Behavioral|Nutritional Counseling & Acceptance-based Therapy|
16023079|NCT02716831|Behavioral|Cognitive Behavioral Therapy for Eating Disorders|
16023080|NCT02716818|Drug|Chronocort®|Chronocort® is a patented oral modified release formulation of hydrocortisone which is intended to mimic, or closely match, the serum levels of endogenous cortisol.
16023081|NCT02716818|Drug|standard glucocorticoid therapy|Subjects in this arm will continue on their standard hydrocortisone therapy
16023082|NCT02716805|Drug|Tremelimumab|Tremelimumab was administered as an intravenous (IV) infusion over 60 ± 5 minutes at a fixed dose of 75 mg, regardless of weight.
16023083|NCT02716805|Drug|Durvalumab|"Durvalumab was administered as an IV infusion over 60 ± 5 minutes at a fixed dose of 1500 mg for subjects weighing > 30 kg. If a subject's body weight dropped to ≤ 30 kg on study, the subject was dosed at 600 mg for as long as the body weight remained ≤ 30 kg.
~When applicable, the durvalumab infusion was to start at least 60 minutes after the end of the tremelimumab infusion."
16023084|NCT02716805|Biological|Prevnar-13|Prevnar-13 was administered as an intramuscular injection. The Prevnar-13 dose and the tremelimumab dose were to be separated by a minimum of 48 hours.
16023085|NCT02716805|Drug|Melphalan|Melphalan was administered as an IV infusion according to institutional standard of care and local prescribing information.
16023086|NCT02716792|Drug|Ibandronate|Participants will receive ibandronate, 6 mg via IV infusion, every 3 weeks for up to 9 cycles. The infusion interval will be either 15 or 60 minutes depending upon treatment group assignment every 3 weeks (9 treatment cycles in total).
16023087|NCT02716779|Drug|Pegylated Interferon (PEG-IFN) alfa-2a|Pegylated interferon (PEG-IFN) alfa-2a (40 kilodalton [KD]) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
16023088|NCT02716779|Drug|Placebo|Ribavirin matching placebo orally (PO) twice daily for 6 weeks.
16023089|NCT02716779|Drug|Ribavirin|Ribavirin, 1000 mg orally (PO) (400 mg in the morning [=2 tablets] and 600 mg in the evening [=3 tablets]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.
16023090|NCT02716766|Drug|Sorafenib|PO
16023091|NCT02716766|Drug|Capecitabine|PO
16023092|NCT02716766|Drug|Oxaliplatin|IV
16023093|NCT02716753|Biological|seminal plasma|
16023094|NCT02716753|Biological|Physiological NaCL solution|
16023095|NCT02716740|Dietary Supplement|Leucine-enriched amino acid supplementation and 30 minutes of physical training 3 times per week|After 3 months of obesity-surgery, if patients lost more than 15% of muscular weight, they will take a leucine-enriched amino acid supplementation during 3 months added with a regular physical training (30 minutes, 3 times/week). Arm A will take 2.46g/day of leucine-enriched amino acid supplementation and arm B 4g/day.
16023096|NCT02716727|Device|Aquasil Ultra Cordless, Dentsply|Cordless gingival displacement procedure
16023097|NCT02716727|Device|Ultrapak, Ultradent cord|Cordless gingival displacement procedure
16023098|NCT02716714|Drug|ingenol mebutate gel 0.015%|-Face or Scalp arm (Referred to Face/Scalp arm): Apply ingenol mebutate gel 0.015% once daily for 3 consecutive days
16023099|NCT02716714|Drug|ingenol mebutate gel 0.05%|-Trunk or Extremities arm (Referred to Trunk/Extremities arm): Apply ingenol mebutate gel 0.05% once daily for 2 consecutive days
16023100|NCT02716701|Behavioral|Exercise Group|
16023101|NCT02716701|Other|Control Group|
16023102|NCT02716701|Other|wristband activity tracker|
16023220|NCT02715817|Other|Conventional therapeutic exercises|It is the use of the conventional therapeutic exercises for rehabilitation of balance and gait in post-stroke patients.
16023103|NCT02716688|Drug|S-1|S-1 will be administered orally twice daily for 14 days at a dose of 70 mg/m2/day with concurrent radiotherapy for 2 cycles. Patients who showed a response greater than that of stable disease underwent additional S-1 until disease progression, serious adverse events, or patient refusal up to four cycles.
16023104|NCT02716688|Radiation|radiotherapy|Radiotherapy wiil be delivered with a daily fraction of 1.8 Gy to a total dose of 50.4 Gy.
16023105|NCT02716675|Biological|VRC01|Administered by IV infusion; total dose will vary based on participant's weight
16023106|NCT02716675|Biological|Placebo for VRC01|Sodium Chloride for Injection USP, 0.9%; administered by IV infusion
16023107|NCT02716662|Dietary Supplement|Axona|medical powder, supplement food
16023108|NCT02716649|Other|No intervention|
16023109|NCT02716636|Procedure|Slow placement of the tenaculum|Slow placement of the tenaculum on the cervix
16023110|NCT02716623|Other|CR diet|Diet consists of meals lower in carbohydrates but does not restrict the number of calories that participants can consume.
16023111|NCT02716623|Behavioral|Exercise|Participants will be asked to undergo specific exercise schedule. Exercise will be tracked using a fitness device.
16023112|NCT02716610|Drug|INH 69 U (low)|inhaled human insulin
16023113|NCT02716610|Drug|INH 69 U (high)|inhaled human insulin
16023114|NCT02716610|Drug|INH 139 U|inhaled human insulin
16023115|NCT02716610|Drug|INH 208 U|inhaled human insulin
16023116|NCT02716610|Drug|LIS 18 U|subcutaneous insulin lispro
16023117|NCT02716597|Drug|25% Albumin|
16023118|NCT02716597|Drug|Placebo|
16023119|NCT02716584|Behavioral|Physical exercise|Veterans in the physical exercise group will participate in a 12-week, instructor-led, outdoor brisk walking exercise program conducted in small groups, held 3 times per week, gradually increasing walking time until reaching a maximum of 40-minutes per session. The heart rate of each Veteran will be monitored during the walking sessions to help ensure maintenance of a target peak heart rate of 60% to 70% of the maximum for the individual's age (i.e., 220-age).
16023120|NCT02716584|Behavioral|Stretching exercise|Veterans in the control condition will participate in instructor-led, non-aerobic stretching exercises conducted in small groups, held 3 times per week.
16023121|NCT02716571|Other|Leukapheresis or Plasmapheresis|"Leukapheresis: Donate 5x10^9 white blood cells and 400 ml of plasma. Plasmapheresis: Donate 400ml of plasma.
~Donated white blood cell and plasma will be manufactured MG4101(allogeneic natural killer cell) to use for Hepatocellular carcinoma(HCC) patients after Transarterial Chemoembolization(TACE)."
16023122|NCT02716558|Other|ART Sealant Application|application of the ART sealant using high viscosity glass inomer cements.
16023123|NCT02716558|Other|Resin sealant application|application of the moisture tolerant sealant according to the manufacturers instructions.
16023124|NCT02716545|Device|balloon assisted enteroscopy|Patients with recurrent bleeding (>2 times for one year) will undergo balloon assisted enteroscopy and be treated with endoscopic therapy if necessary. Currently available endoscopic modalities are argon laser, bipolar electrocoagulation (BiCAP), band ligation, cryotherapy, radiofrequency ablation and argon plasma coagulation (APC). Among these options, APC is the most promising.
16023125|NCT02716532|Dietary Supplement|Peptamen AF|Each patient will receive Peptamen AF throughout the trial.
16023126|NCT02716519|Biological|Santyl|Collagenase ointment applied topically once per day for up to six weeks
16023127|NCT02716519|Other|Standard Care|Standard Care not specified by the protocol; Investigators choose the appropriate standard care treatment for each participant
16023128|NCT02716506|Procedure|POP surgery|Any surgical procedure that is done to treat the symptomatic POP
16023129|NCT02716493|Behavioral|Telerehabilitation program|"The intervention was an 8-week home-based telerehabilitation program (three sessions of about 75 minutes per week) using the eChez-Soi telerehabilitation platform.
~Through a unique software interface, the eChez-Soi allows for the following three technological aspects: 1- continuous data acquisition and recording from commercial biometric sensors; 2- continuous transmission of the collected data via the Internet to the clinician's computer, allowing the clinician to visualize the biomechanical and physiological parameters in real time; and 3- a challenging gaming environment with interactive exercises performed on musical rhythms.
~In total, 15 supervised sessions and 9 unsupervised sessions were planned for a total of 24 exercise sessions"
16023130|NCT02716480|Behavioral|Mobility coaching|"The intensive follow-up for the patients of Mobility Coaching  arm will consist on a monthly remote coaching of 20 to 30 minutes led by a Mobility coach. The web platform allows self-administration of a questionnaire to establish patient's diagnosis of mobility to enable personalized coaching. The web platform can also track the parameters collected by connected devices (pedometer and connected scale), organize appointments with patients and ensure the traceability of exchanges with patients. A smartphone application tracks different modes of locomotion used."
16023131|NCT02716480|Behavioral|Diet coaching|"The intensive follow-up for the patients of Diet Coaching  arm will consist on a monthly remote coaching of 20 to 30 minutes led by dietitian trained in the care of patients undergoing bariatric surgery."
16023132|NCT02716467|Other|intercessory prayer|Intercessory prayer will be offered by a group of six Christian people.
16023133|NCT02716467|Radiation|Radiotherapy|All participants will receive treatment by radiotherapy
16023134|NCT02716454|Procedure|Ileocaecal resection|laparoscopic ileocaecal resection with primary anastomosis
16023135|NCT02716441|Device|Radio-opaque Tissue Markers|All participants will undergo implantation of radio-opaque tissue markers on their repaired rotator cuff at the time of surgery.
16023136|NCT02716428|Drug|Faldaprevir|
16023137|NCT02716428|Drug|TD-6450|
16023138|NCT02716428|Drug|Ribavirin|
16023139|NCT02716415|Drug|Calmoseptine Ointment|"A full structured skin care regimen is provided in a consistent fashion either by study personnel or by the participant's primary carer (family or ward staff) at each diaper change. Study nurse sub-investigator visit each participant twice per nursing shift (six times per day) either to deliver the care regimen or to observe that it is being delivered.
~The regimen includes:
~regular diaper changing,
~gentle cleansing
~application of the trial ointment"
16023221|NCT02715817|Other|Virtual Rehabilitation and Conventional Therapeutic Exercise|It is the use of the conventional exercises and of the NW for rehabilitation of balance and gait in post-stroke patients.
16023265|NCT02715570|Drug|Placebo - repeat doses|Safety and tolerability of repeat doses
16023140|NCT02716415|Drug|Destin Maximum Strength 40% Zinc|"A full structured skin care regimen is provided in a consistent fashion either by study personnel or by the participant's primary carer (family or ward staff) at each diaper change. Study nurse sub-investigator visit each participant twice per nursing shift (six times per day) either to deliver the care regimen or to observe that it is being delivered.
~The regimen includes:
~regular diaper changing,
~gentle cleansing
~application of the trial ointment"
16023141|NCT02716402|Radiation|Cerebral MRI and V/Q SPECT/CT|Cerebral MRI and V/Q SPECT/CT
16023142|NCT02716389|Other|Zebris CMS 70|
16023143|NCT02716389|Other|3-D Bulls Eye Spirit Meter|
16023144|NCT02716376|Device|Otovent®|Otovent® is a special designed balloon that is blown up through the nose, also referred to as auto-inflation of the eustachian tube. The patients use the Otovent® 5 times a day.
16023145|NCT02716363|Device|Rotational Atherectomy by Rotablator|
16023146|NCT02716350|Dietary Supplement|B-GOS|comparison versus placebo
16023147|NCT02716350|Dietary Supplement|Maltodextrin|placebo
16023148|NCT02716337|Dietary Supplement|Addition of human milk fortifiers according to human milk analysis|
16023149|NCT02716324|Behavioral|Care Manager CM)|The CM was an individual responsible for communicating and coordinating ADHD care. The CM established rapport with families and communicated with them every 3 months or more frequently if needed to assess treatment use, identify new concerns, and help problem-solve. The CM also communicated with the patient's ADHD care team (pediatrician, teacher, mental health providers) to clarify family goals, communicate information, and coordinate treatment.
16023150|NCT02716324|Other|ADHD Portal|The ADHD portal was a web-based platform that permits access to parts of the hospital's electronic health record. The portal permits (1) capture and sharing of patient and family treatment preferences and goals, (2) monitoring of ADHD symptoms, treatment receipt, and side effects, and (3) assessing goal attainment. The system prompts for completion of periodic check-in surveys (bi-weekly to 3 months) with parents and teachers. Within the portal, preferences and goals for ADHD treatment were measured using the ADHD Preference Goal Instrument (PGI) (Fiks et al., 2012). Parents were encouraged to consult with their children when completing the tool.
16023151|NCT02716311|Drug|Afatinib|
16023152|NCT02716311|Drug|Cetuximab|
16023153|NCT02716298|Device|fanfilcon A|contact lens
16023154|NCT02716298|Device|lotrafilcon B|contact lens
16023155|NCT02716285|Drug|Ileocolonic release peppermint oil|Peppermint oil, menthae piperitae aetheroleum
16023156|NCT02716285|Drug|Placebo|Placebo capsule, containing microcrystalline cellulose
16023157|NCT02716285|Drug|Small intestinal release peppermint oil|Peppermint oil, menthae piperitae aetheroleum
16023158|NCT02716272|Drug|Nivolumab|Nivolumab administered IV over 60 minutes at 3mg/kg every 2 weeks
16023159|NCT02716272|Drug|Nivolumab + Ipilimumab|Nivolumab administered IV over 60 minutes at 3mg/kg every 2 weeks, combined with Ipilimumab administered IV over 90 minutes at 1mg/Kg every 6 weeks
16023160|NCT02716259|Procedure|Scaling and root planing|Two sessions of scaling and root planing under local anesthesia and clorhexidine rinse twice/day, 15 days
16023161|NCT02716259|Procedure|Supragingival prophylaxis|Two sessions of scaling and root planing under local anesthesia and sodium fluoride rinse, twice/day, 15 days
16023162|NCT02716246|Biological|ABO-102|Self-complementary adeno-associated virus serotype 9 carrying the human SGSH gene under the control of a U1a promoter (scAAV9.U1a.hSGSH) will be delivered one time through a venous catheter inserted into a peripheral limb vein.
16023163|NCT02716233|Drug|pegaspargase 1250 IU/m2 x 2|only for ALL of standard risk and medium risk
16023164|NCT02716233|Drug|pegaspargase 2500 IU/m2 x 1|only for ALL of standard risk and medium risk
16023165|NCT02716220|Device|Percutaneous Coronary Intervention|Implanttaion fo the DREAMS 2G Scaffold
16023166|NCT02716207|Device|CyberKnife|Radiation Therapy
16023167|NCT02716194|Biological|BAX 826|
16023168|NCT02716194|Biological|Octocog alfa|
16023169|NCT02716181|Device|"Атопик Soothing Cream"|Topical application of a study cream to involved skin areas twice a day.
16023170|NCT02716181|Device|Placebo|Topical application of a study placebo cream to involved skin areas twice a day.
16023171|NCT02716168|Other|Shared video consultation between patient, general practitioner and oncologist|At the start of the patients chemotherapy treatment a shared video consultation between the patient, general practitioner and oncologist will bee arranged. The video consultation should address distribution of roles, comorbidity, medicine, depression and anxiety symptoms, relatives and social resources.
16023172|NCT02716142|Drug|rectal misoprostol|patients will take 2 tablets of rectally misoprostol 400 microgram 60 minutes before the procedure
16023173|NCT02716142|Drug|sublingual misoprostol|patients will take 2 tablets of sublingual misoprostol 400 microgram 60 minutes before the procedure
16023174|NCT02716129|Drug|Morphine|38 patients of this group will receive 10 mg of 0.5% hyperbaric bupivacaine (Buvanest Spinal 0.5% Heavy) with 0.2 mg morphine (Infumorph - Injection 10 mg/mL) in 0.5 ml volume (total volume 2.5 mL). Patients will be preloaded with 10 ml/kg Ringer's lactate solution intravenous.
16023175|NCT02716129|Drug|Morphine plus Nalbuphine|39 patients of this group will receive 10 mg of 0.5% hyperbaric bupivacaine (Buvanest Spinal 0.5% Heavy) with 0.5 mg morphine (Infumorph - Injection 10 mg/mL) plus 0.2 mg nalbuphine (NALUFIN 20MG/ML AMP) in 0.5 ml volume (total volume 2.5 mL). Patients will be preloaded with 10 ml/kg Ringer's lactate solution intravenous.
16023176|NCT02716116|Drug|TAK-788|TAK-788 capsules.
16023177|NCT02716116|Drug|Pemetrexed|Pemetrexed intravenous infusion.
16023178|NCT02716116|Drug|Carboplatin|Carboplatin intravenous infusion.
16023179|NCT02716103|Other|blood collection|
16023180|NCT02716103|Other|bone marrow collection|
16023181|NCT02716090|Drug|Adapalene and Benzoyl peroxide Dalap Duo®|
16023182|NCT02716090|Drug|Adapalene and Benzoyl peroxide Epiduo®|
16023183|NCT02716077|Radiation|FDG PET/CT imaging|
16023184|NCT02716064|Behavioral|TAP-CM Intervention|The intervention includes: 1) Healthy Lifestyle App Goal Setting and Prioritization and modules, 2) TAP-CM Report triage Huddle with Interprofessional Team 3) The connection of patients to appropriate community resources 4) Volunteer helping with technology use
16023185|NCT02716051|Device|MRI|Whole body MRI with cardiac and pulmonary synchronization
16023186|NCT02716051|Device|PET|
16110652|NCT02084069|Drug|Atorvastatin|
16023187|NCT02716038|Drug|MPDL3280A|MPDL3280A is a human, Fc optimized, monoclonal antibody directed against the protein ligand programmed cell death-1 ligand 1 (PD-L1), with potential immune checkpoint inhibitory and antineoplastic activities. Atezolizumab binds to PD-L1, blocking its binding to and activation of its receptor programmed death 1 (PD-1) expressed on activated T-cells, which may enhance the T-cell-mediated immune response to neoplasms and reverse T-cell inactivation. MPDL3280A 1200 mg will be administered as a 60 minute IV infusion on first administration, then over 30 minutes subsequently if tolerated.
16023188|NCT02716038|Drug|Carboplatin|Carboplatin is a second-generation platinum compound with a broad spectrum of antineoplastic properties. Carboplatin contains a platinum atom complexed with two ammonia groups and a cyclobutane-dicarboxyl residue. This agent is activated intracellularly to form reactive platinum complexes that bind to nucleophilic groups, thereby inducing intrastrand and interstrand DNA cross-links, as well as DNA-protein cross-links. These carboplatin-induced DNA and protein effects result in apoptosis and cell growth inhibition. Carboplatin area under the curve (AUC)=6 will be administered as a 30 minute IV infusion immediately after nab-paclitaxel.
16023189|NCT02716038|Drug|Nab-paclitaxel|Nab-paclitaxel is an albumin-stabilized nanoparticle formulation of the natural taxane paclitaxel with antineoplastic activity. Nab-paclitaxel binds to and stabilizes microtubules, preventing their depolymerization and so inhibiting cellular motility, mitosis, and replication. Nab-paclitaxel 100 mg/m2 will be administered as a 30 minute IV infusion.
16023190|NCT02716025|Procedure|Upper gastrointestinal endoscopy|Thorough examination of the esophagus, stomach and duodenum to the second part was done to all patients using Olympus CV-150 or Pentax EPM-3500.
16023191|NCT02716012|Drug|MTL-CEBPA|Intravenous administration
16023192|NCT02716012|Drug|Sorafenib 200mg|Sorafenib tablets
16023193|NCT02715999|Procedure|Quadratus Lumborum Block|After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 50% oxygen and % 50 air ; 1ug/kg fentanyl and 3 mg/kg propofol is administered intravenously. Then laryngeal mask is inserted when conditions are satisfactory.All patients will be in the lateral position . Under ultrasound guidance a 22 Gauge, Pajunk Sonoplex(medical Germany) needle will be used for both techniques. Under ultrasound 0.5 ml/kg bupivacaine 0.2 % injected unilaterally at the posterior border of the quadratus lumborum muscle
16023194|NCT02715999|Procedure|Transversus Abdominis Plane Block|After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane inhalation in 50% oxygen and % 50 air ; 1ug/kg fentanyl and 3 mg/kg propofol is administered intravenously. Then laryngeal mask is inserted when conditions are satisfactory. All patients will be in the lateral position . Under ultrasound guidance a 22 Gauge, Pajunk Sonoplex(medical Germany) needle will be used for both techniques. Under ultrasound 0.5 ml/kg bupivacaine 0.2 % injected unilaterally between internal oblique and transversus abdominis muscles.
16023195|NCT02715986|Device|3T MRI|Four visits will be conducted during the prospective follow during which will be carried out a 3T MRI examination, assessment of assessment of depressive symptomatology and anterograde memory: within 7 days prior to the first session of ECT, within 48 hours after the first ECT session, within 48 hours after the first effective ECT session and within 10 days of the last session of ECT.
16023196|NCT02715973|Dietary Supplement|Nutritional Supplement|Energy dense supplement appox. 2 kcal/mL, prepared from locally available, affordable, socially acceptable food items - milk, sugar, edible coconut oil, egg and custard powder as base) in addition to standard nutritional counseling by a trained dietician as per the recommended daily allowance according to gender and age.
16023197|NCT02715973|Dietary Supplement|Standard Nutritional Treatment|Standard nutritional counseling by a trained dietician as per the recommended daily allowance according to gender and age
16023198|NCT02715960|Drug|Acitretin Capsules|During The first treatment stage:10mg per day, 3 days,oral; The second stage: 20mg per day, 3 days,oral; The third stage: 30mg per day, and maintain this dose,oral.
16023199|NCT02715947|Drug|Methotrexate|During The first week: 7.5mg per week, oral; The second and third weeks: 10mg per week, oral; The fourth and fifth weeks: 12.5mg per week,oral; The sixth week:15mg per week, and maintain this dose, oral.
16023200|NCT02715934|Other|Glucose to Goal|The Glucose to Goal intervention applies elements of the Patient Centered Medical Home (i.e., practice design, decision support, population management, etc) to diabetes education services and operationalizes the current DSME objectives in the primary care setting.
16023201|NCT02715934|Other|Usual Care|The control group will follow the traditional DMSE delivery model, which includes primary care providers referring patients to an outpatient, hospital-based diabetes educator for DSME, but in a passive manner (i.e., without proactive patient identification), which is the usual process for referrals.
16023202|NCT02715921|Other|Tele-exercise|
16023203|NCT02715908|Drug|LBEC0101|Etanercept 50mg
16023204|NCT02715895|Dietary Supplement|Friso|Friso formula feeding on demand for 3 months
16023205|NCT02715895|Dietary Supplement|Wyeth|Wyeth formula feeding on demand for 3 months
16023206|NCT02715895|Dietary Supplement|Breast milk|Breast milk feeding on demand
16023207|NCT02715882|Drug|CBLB502|
16023208|NCT02715882|Drug|Placebo|
16023209|NCT02715869|Drug|A pharmacologic cardiac preconditioning (Sevoflurane)|A Patients are anaesthetized by Sevoflurane more than 1 mac.
16023210|NCT02715869|Procedure|B ischeamic preconditioning|B ischemic preconditioning will be done after induction and before cardiopulmonary bypass by inflation the cuff of blood pressure above 200mmhg in the lower limb every 5 min for 3cycles
16023211|NCT02715856|Other|Monitoring Device|Undergo surgical wound and physical activity monitoring
16023212|NCT02715856|Other|Physical Activity Measurement|Undergo physical activity measurement
16023213|NCT02715856|Other|Quality-of-Life Assessment|Ancillary studies
16023214|NCT02715856|Other|Questionnaire Administration|Ancillary studies
16023215|NCT02715856|Procedure|Standard Follow-Up Care|Undergo standard follow-up care
16023216|NCT02715856|Other|Survey Administration|Ancillary studies
16023217|NCT02715843|Drug|MT-3724|Intravenous dosing M-W-F X 2 weeks; MT-3724 infusion over 2 hours on each dosing day over 4 week initial cycle and then 3 week repeat cycles for up to 5 total cycles.
16023218|NCT02715830|Procedure|Angioplasty of distal arteries|angioplasty of the arteries bellow-the-knee
16023219|NCT02715817|Other|Virtual Rehabilitation|It is the use of the NW games for rehabilitation of balance and gaite in post-stroke patients.
16023263|NCT02715570|Drug|Placebo - single doses|Safety and tolerability of single doses
16023222|NCT02715804|Other|Biological: PEGylated Recombinant Human Hyaluronidase (PEGPH20)|PEGPH20 will be administered as per the dose and schedule specified in the respective arms.
16023223|NCT02715804|Drug|Placebo|Matching placebo for PEGPH20
16023224|NCT02715804|Drug|nab-Paclitaxel|Nab-paclitaxel will be administered as per the dose and schedule specified in the respective arms.
16023225|NCT02715804|Drug|Gemcitabine|Gemcitabine will be administered as per the dose and schedule specified in the respective arms.
16023226|NCT02715791|Behavioral|TAP-HC-DM|"Patients randomized to the intervention group will complete the Healthy Lifestyle App modules. Their results will create a report with a suggested list of tip sheets that patients, volunteers, and clinics will see.
~Patients will also be encouraged to access the McMaster PHR in order to track their health, and communicate with volunteers or the clinic.
~Volunteer health connectors will connect with patients at least weekly, by phone, McMaster PHR message, or in person (depending on patient preference). They will be motivating, providing tip sheets or other education, doing tech support, providing community resources, and building a volunteer-patient relationship with the client.
~Clinicians will see and triage the reports, and may follow up on various aspects identified."
16023227|NCT02715791|Other|Usual Care|Patients randomized to the control group will receive usual care and upon the end of the intervention arm of the study will receive the TAPESTRY-HC-DM intervention as detailed in the intervention group.
16023228|NCT02715765|Device|Transcranial Direct Current Stimulation|Energetic parameters are 2mA for 20 min with SPONSTIM-25 25cm2 electrodes. Current delivery is initiated in a ramp-like fashion over 10s from 0mA to 2mA. Once at 2mA, the current is held constant for the entire session. At the end of stimulation, current is decreased in a ramp-like fashion over 10s from 2mA to 0mA. Should the participant not be able to tolerate a current of 2mA due to pain or irritation, the current will be decreased down to a minimum of 1.5mA. If 1.5 mA is still not tolerable, the participant will be removed from the study. Electrode placement is based on the international 10-20 electrode placement system. The anode is placed at the midpoint between F3 and FP1, a location corresponding approximately to the left dorsolateral prefrontal cortex, and the cathode placed at the midpoint between T3 and P3, a location corresponding to left temporo-parietal junction
16023229|NCT02715765|Device|Transcranial Random Noise Stimulation|Energetic parameters are 2mA for 20 min with SPONSTIM-25 25cm2 electrodes. Current delivery is initiated in a ramp-like fashion over 10s from 0mA to 2mA. Once at 2mA, the current alternates at 2mA with a 0mA offset applied at random frequencies over a range of 0.1 to 100 Hz. At the end of stimulation, current is decreased in a ramp-like fashion over 10s from 2mA to 0mA. Should the participant not be able to tolerate a current of 2mA due to pain or irritation, the current will be decreased down to a minimum of 1.5mA. If 1.5 mA is still not tolerable, the participant will be removed from the study. Electrode placement is based on the international 10-20 electrode placement system. The anode is placed at the midpoint between F3 and FP1, a location corresponding approximately to the left dorsolateral prefrontal cortex, and the cathode placed at the midpoint between T3 and P3, a location corresponding to left temporo-parietal junction
16023230|NCT02715765|Device|Transcranial Sham Stimulation|Energetic parameters are 2mA for 20 min with SPONSTIM-25 25cm2 electrodes. The sham procedure involves only 40 sec stimulation at 2mA and then drops to 0mA with 15msec pulses every 550msec. Should the participant not be able to tolerate a current of 2mA due to pain or irritation, the current will be decreased down to a minimum of 1.5mA. If 1.5 mA is still not tolerable, the participant will be removed from the study. Electrode placement is based on the international 10-20 electrode placement system. The anode is placed at the midpoint between F3 and FP1, a location corresponding approximately to the left dorsolateral prefrontal cortex, and the cathode placed at the midpoint between T3 and P3, a location corresponding to left temporo-parietal junction
16023231|NCT02715752|Dietary Supplement|Gene-Eden-VIR/Novirin|
16023232|NCT02715739|Other|No intervention|
16023233|NCT02715726|Drug|Alirocumab|Pharmaceutical form:solution Route of administration: subcutaneous
16023234|NCT02715726|Drug|Placebo for alirocumab|Pharmaceutical form:solution Route of administration: subcutaneous
16023235|NCT02715726|Drug|ezetimibe|Pharmaceutical form:capsule Route of administration: oral
16023236|NCT02715726|Drug|placebo for ezetimibe|Pharmaceutical form:capsule Route of administration: oral
16023237|NCT02715726|Drug|atorvastatin|Pharmaceutical form:tablet Route of administration: oral
16023238|NCT02715726|Drug|rosuvastatin|Pharmaceutical form:tablet Route of administration: oral
16023239|NCT02715726|Drug|simvastatin|Pharmaceutical form:tablet Route of administration: oral
16023240|NCT02715700|Drug|Methadone|Methadone 20 to 200 mg (10 mg/mL if oral solution concentrate) oral tablet once per day.
16023241|NCT02715700|Drug|Doravirine|Doravirine 100 mg oral tablet once per day.
16023242|NCT02715687|Drug|Amiodarone|Will receive 30 days treatment with oral amniodarone of 200mg
16023243|NCT02715687|Drug|Placebo|Will receive 30 days treatment with oral placebo of 200mg
16023244|NCT02715674|Device|Plasti-med TRIFLO|
16023245|NCT02715674|Device|BIPAP VISION|
16023246|NCT02715674|Device|Plasti-med oxygen therapy mask|
16023247|NCT02715661|Other|exercise|six-month interval of exercise
16023248|NCT02715648|Drug|Phenazopyridine|
16023249|NCT02715635|Biological|Typhoid vaccine|The typhoid vaccine is composed of purified polysaccharide from S. typhi capsule 25 micrograms contained in 0.5 ml solution
16023250|NCT02715635|Dietary Supplement|Concentrate beetroot Juice|140 ml containing ~8 mmol of inorganic nitrate
16023251|NCT02715635|Dietary Supplement|Concentrate beetroot Juice (Placebo)|140 ml which is nitrate-depleted
16023252|NCT02715622|Procedure|Hernia repair|Patient undergoing Hernia repair using different surgical modalities as per the surgeon's standard of care practice
16023258|NCT02715596|Dietary Supplement|EPA supplementation|2.7 g EPA supplementation in a 15 cc emulsion stick-pack
16023259|NCT02715596|Other|Placebo|placebo in 15 cc emulsion stick-pack
16023260|NCT02715583|Drug|11C-Acetate|
16023261|NCT02715583|Drug|Ra-223 therapy|
16023262|NCT02715570|Drug|PC945 - single doses|Safety and tolerability of single doses
16111032|NCT02081027|Other|placebo|
16023266|NCT02715557|Behavioral|Relapse prevention program|The relapse prevention program is an innovative computer-based coping skills educational program for adolescent substance abuse treatment completers.
16023267|NCT02715544|Other|Healthy lifestyle|The families will receive a designed for these purposes intervention
16023268|NCT02715544|Other|physical activity and dietary guidelines|The families will receive a designed for these purposes intervention
16023269|NCT02715531|Drug|5-FU|5-FU (400 mg/m^2) will be administered as an IV bolus, followed by 2400 mg/m^2 by continuous IV infusion over 46 (± 1) hours, q2w.
16023270|NCT02715531|Drug|Atezolizumab|Participants will receive atezolizumab in a flat dose of 1200 mg q3w (Arm A, Group E2, and Arm F) or 840 mg q2w (Arm B, Arm C, and Groups E1 and E3).
16023271|NCT02715531|Drug|Bevacizumab|Participants will receive bevacizumab at 15 mg/kg q3w (Arm A and Group F1) or 10 mg/kg q2w (Arm B).
16023272|NCT02715531|Drug|Gemcitabine|Gemcitabine will be administered according to the local prescribing information. The starting dose-level of gemcitabine (1000 mg/m^2) will be administered intravenously over 35 (± 5) minutes on Days 1, 8, and 15 of each 28-day cycle (3-weeks-on/1-week-off schedule).
16023273|NCT02715531|Drug|Leucovorin|Leucovorin 200 mg/m^2 L-isomer form or 400 mg/m^2 D,L-racemic form will be administered IV over 120 (± 15) minutes, q2w.
16023274|NCT02715531|Drug|Nab-Paclitaxel|Nab-Paclitaxel will be administered according to the local prescribing information. The starting dose-level of nab-paclitaxel (125 mg/m^2) will be administered intravenously over 35 (± 5) minutes on Days 1, 8, and 15 of each 28-day cycle (3-weeks-on/1-week-off schedule).
16023275|NCT02715531|Drug|Oxaliplatin|Oxaliplatin 85 mg/m^2 will be administered IV over 120 (± 5) minutes q2w.
16023276|NCT02715531|Drug|Capecitabine|Capecitabine may be administered after 6 months at the discretion of the investigator (range of 650-1000 mg/m^2) twice daily on Days 1-4 of a 21-day cycle.
16023277|NCT02715531|Drug|Cisplatin|Cisplatin will be administered as 80 mg/m^2 IV over 120 minutes q3w (Group E2).
16023278|NCT02715518|Device|PCI using 2nd generation drug-eluting stent|"Percutaneous coronary intervention (PCI) using 2nd generation drug-eluting stent for non-IRA stenosis will be decided according to the allocated arms.
~FFR-guided strategy arm
~Angiography-guided strategy arm"
16023279|NCT02715505|Drug|Umbilical cord blood transplantation with HSC835|Hematopoietic Stem cell transplantation will be done with the cell therapy product HSC835
16023280|NCT02715492|Drug|LMWH|(Enoxheparin) 1 IU/kg per dose twice daily for 2 weeks from the 1st day of TACE
16023281|NCT02715492|Procedure|TACE|Trans arterial chemoembolization
16023282|NCT02715479|Drug|Dolutegravir|Dolutegravir
16023283|NCT02715479|Drug|BMS955176|BMS955176
16023284|NCT02715466|Drug|Balanced gelatine solution|Gelaspan combined with Sterofundin ISO
16023285|NCT02715466|Drug|Balanced electrolyte solution|Sterofundin ISO
16023286|NCT02715453|Other|Intervention on frailty|"Multidisciplinary team (physicians, nurses, physiotherapists, and nutritionists):
~Nutritional evaluation and intervention after randomization and regularly during follow-up
~Physiotherapy sessions for 3 months after randomization and home exercise program for 1 year
~Psychiatrist or psychologist assistance for 1 year after discharge"
16023287|NCT02715440|Drug|Immediate intervention|Gradual withdrawal of benzodiazepines or related drugs
16023288|NCT02715427|Other|Conventional care|
16023289|NCT02715427|Other|Enhanced recovery|
16023290|NCT02715414|Behavioral|Multiple Family Group + Clinic Implementation Team|Clinic Implementation Teams (CIT) include providers at the clinic that aim to enhance uptake and implementation of MFG through modifications of MFG (e.g., format, length of sessions), but no modification to content will occur.
16023291|NCT02715414|Behavioral|MFG|MFG is a 12-week group involving 6-8 families of children with problem behaviors. MFG aims to reduce family-level factors that are associated with the onset and perpetuation of problem behaviors. Eight of the 12 sessions are devoted to rules, responsibilities, respectful communication and relationships. Four additional sessions target family stress and social support.
16023292|NCT02715401|Drug|HCP1303|
16023293|NCT02715401|Drug|HGP1201|
16023294|NCT02715401|Drug|HIP1402|
16023295|NCT02715388|Device|GlasScope Surgical Microscope|3D visualization of the poterior chamber for silicon oil removal
16023296|NCT02715375|Device|CREON2000A|
16023297|NCT02715362|Drug|TAI-GPC3-CART cells|TAI as a local drug delivery pathway, so that more T cells gathered at the tumor site, less T cells to migrated to the normal tissue, thereby enhancing the efficacy of anti-tumor, reducing the potential of side effects. And GPC3-CART is a 2nd CAR, with GPC3 as the target protein, 4-1BB as a co- stimulator
16023298|NCT02715349|Behavioral|Psychoeducation|3 session psychoeducation program with the family, and 3 session psychoeducation program with the patient, after psychosis is controlled. Psychoeducation focuses on explaining schizophrenia as a medical illness, the prognosis, and how the patient and family can increase the likelihood of better outcome.
16023299|NCT02715336|Drug|Ovulation induction with hCG and Lupron (GnRH agonist)|Patients treated for infertility are categorized as a low-, normal- or high responder according to their estimated ovarian response to hormonal stimulation. This classification dictates the hormonal stimulation regimen that they will receive. In contrast to hCG triggering, GnRHa triggering is characterized by simultaneous LH and FSH surges, similar to natural ovulation. A combination of GnRHa plus hCG for triggering creates simultaneous LH and FSH surges by the GnRHa, which resembles physiologic ovulation triggering, together with sustained LH-like activity from the hCG, stimulating the corpus luteum to excrete sufficient hormonal endometrial support.
16023300|NCT02715323|Other|Cross-sectional study|
16023301|NCT02715297|Radiation|SRT to the resection cavity|46 Gy total dose will be delivered in 2 Gy per fraction, or 36 Gy delivered in 3 Gy per fraction, 5 fractions within 1 week. Doses will have to cover 95% of the PTV with the prescribed dose. The clinical target volume (CTV) will be defined as the resection cavity of the recurrent glioblastoma plus a margin of 5mm. A CTV to PTV margin of 1 to 3mm will be added according to technique used for immobilisation.
16023336|NCT02715063|Other|Usual clinical care|Dietary restriction (1300-1500kcal) 50-52% carbohydrates, 33-35% fat, 15-20% protein
16023337|NCT02715050|Device|Active or Placebo Phototherapy (MR4)|
16023338|NCT02715037|Other|Throat swabbing|
16023339|NCT02715024|Drug|Tamsulosin|Oral
16023340|NCT02715024|Drug|Solifenacin|Oral
16023341|NCT02715011|Drug|JNJ-63709178|Participants will receive JNJ-63709178 in Part 1 and Part 2.
16023302|NCT02715284|Biological|Dostarlimab|Dostarlimab (160 mg, 20 mg/mL; or 500 mg, 50 mg/mL) is a humanized monoclonal antibody that binds with high affinity to PD-1 resulting in inhibition of binding to programmed death receptor ligands 1 and 2 (PD-L1 and PD-L2). Dostarlimab will be administered via a 30 minute IV infusion on Day 1 and Day 15 of each cycle in Part 1. For additional patients enrolled specifically to better characterize the PK/PDy profile in Part 1, dostarlimab administration during Cycle 1 will only occur on Day 1 with the second dose administered on Cycle 2/Day 1 and Q2W thereafter. For Part 2A and 2B, dostarlimab will be administered on Day 1 of each treatment cycle. Cycle duration for Q3W dosing is 21 days and Q6W dosing is 42 days.
16023303|NCT02715271|Procedure|therapeutical surgery for TB|Patients undergoing therapeutical surgery for tuberculosis (DS- and MDR/XDR-TB) indicated as per clinical routine
16023304|NCT02715258|Drug|Bexagliflozin|tablets containing 20 mg bexagliflozin
16023305|NCT02715258|Drug|Placebo|tablets matching the appearance of bexagliflozin tablets
16023306|NCT02715245|Procedure|Home-based rehabilitation|Procedure/Surgery: Home-based rehabilitation In the patient's home, the primarily applied treatment has been physical therapy, seeking to achieve the highest possible functionality and gait training. In more than 25% of cases, health education is conducted for families and caregivers. Thus, consistent with the patient's condition and their tolerance to activity and to exercise their self-care independently, rehabilitation interventions are activated that prevent sequelae derived from functional limitations.
16023307|NCT02715232|Drug|Testosterone|100mg testosterone undecanoat every 8-12 weeks, or alternatively 50mg testosterone transdermally, or 50mg testosterone creme
16023308|NCT02715232|Drug|Lynestrenol|2-3 tablets/day, if menstruation still occurs
16023309|NCT02715232|Drug|Cyproterone Acetate|25mg daily
16023310|NCT02715232|Drug|Estradiol|75 microgram transdermal therapeutic system twice a week, or p.o. estradiol 2x2mg/day, or estradiol gel 1,5-3mg
16023311|NCT02715232|Drug|Triptorelin acetate|4,12mg every 4-6 weeks (powder for suspension for injection s.c. or i.m.
16023312|NCT02715219|Other|Asthma Education Programme|The Asthma Education Programme consists of four items. 1. Education video for Asthmatic patient adapted from Info Sehat by Bahagian Pendidikan Kesihatan Kementerian Kesihatan Malaysia which is explaining about Asthma disease, medication and patient responsibility in Asthma management. 2. Small group discussion with subject's to help them understand better in Asthma management. 3. Face to face demonstration and teaching of inhaler technique by three trained nurse in small group range of two to five subjects. At the end of the AEP subject will received a 4. Pamphlet will be obtain from Patients' Education Unit in Ampang Hospital containing vital information about Asthma disease and management. The intervention estimated will take 1 hour to 1 hour 30 minutes to be completed.
16023313|NCT02715206|Behavioral|keepin' it REAL classic|keepin' it REAL consists of 10 classroom lessons implemented in 7th grade and 4 booster sessions implemented in 8th grade by the classroom teacher following training
16023314|NCT02715206|Behavioral|keepin' it REAL rural|keepin' it REAL rural drug prevention curriculum consists for 10 lessons taught in 7th grade and 4 booster sessions taught in 8th grade.
16023315|NCT02715206|Behavioral|control|control group continues to teach whatever prevention curriculum they were using prior to study
16023316|NCT02715193|Biological|REMD-477|
16023317|NCT02715193|Biological|Placebo Comparator|
16023318|NCT02715180|Radiation|low dose chest computed tomography|All participants were evaluated 2 scout films during LDCT screenings. The first scout film was obtained while a participant was holding a comfortable expiration with the arms at down position, and the second scout film was obtained while a full inspiration with the arms at raised position. The axial images of LDCT were taken during participants' full inspiration. The radio-opaque marker was attached to the participants' skin where the lowest part of sternum was palpable, because the sternum moves according to the position of arms and respiration.
16023319|NCT02715167|Drug|Budesonide novolizer|
16023320|NCT02715167|Drug|Placebo|
16023321|NCT02715154|Drug|Dexmedetomidine|The dexmedetomidine groups (n = 20 ) will receive i.v. infusion of 0.5 μg/kg of solution containing 5 µg/mL of dexmedetomidine, at 10 min after the level of anesthesia completed. Followed with 0.1ml/kg/hr continuous infusion until the closure of the abdominal.The placebo and the dexmedetomidine solutions will be looked identical and their infusions will be continued until skin closure.
16023322|NCT02715154|Drug|Placebo|The placebo group (n = 20) will pumped in the same volume of saline 0.9% as calculated by patients' weight in 10 min, then will receive an i.v. infusion of 0.1 mL/kg/h saline 0.9%, until the closure of the abdominal. The placebo and the dexmedetomidine solutions will be looked identical and their infusions will be continued until skin closure.
16023323|NCT02715141|Behavioral|Collection of stool sample|Collection of stool sample prior to the scheduled surveillance colonoscopy.
16023324|NCT02715128|Device|Transcranial direct current stimulation (tDCS)|non-invasive electric brain stimulation method
16023325|NCT02715115|Drug|NNZ-2566|Glycyl-L-2-Methylpropyl-L-Glutamic Acid (NNZ-2566) supplied as a lyophilized powder for reconstitution with strawberry flavored solution 0.5% v/v in Water for Injection.
16023326|NCT02715115|Drug|Placebo|Strawberry flavored solution and Water for Injection
16023327|NCT02715089|Genetic|Precise treatment|During screening stage, all patients should accept next-generation sequencing (NGS) test.
16023328|NCT02715076|Other|Ambient Temperature 19°C|Ambient Temperature 19°C
16023329|NCT02715076|Other|Ambient Temperature 21°C|Ambient Temperature 21°C
16023330|NCT02715076|Other|Ambient Temperature 23°C|Ambient Temperature 23°C
16023331|NCT02715076|Device|Forced-air cover (Bair hugger 63500, 3M)|Patients assigned to forced-air warming will also be covered with a gown and surgical drapes, but a forced-air cover (Bair hugger 63500, 3M) will be inserted between the gown and the skin surface.
16023332|NCT02715076|Other|Passive insulation|Patients assigned to passive insulation will be covered as usual with a cotton gown and single layer of cloth surgical draping.
16023333|NCT02715063|Behavioral|High Intensity Interval|Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
16023334|NCT02715063|Behavioral|Resistance training|Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
16023335|NCT02715063|Behavioral|Plus: High Intensity Interval + Resistance Training|Exercise will be performed at three sessions per week. All sessions will be supervised by a trained health or exercise professional.
16023342|NCT02714998|Drug|Methotrexate|single dose systemic methotrexate administration (50 mg/m2)
16023343|NCT02714998|Procedure|salpingectomy|Laparoscopic unilateral salpingectomy
16023344|NCT02714972|Device|Hyperglycemia Minimization Algorithm|The hyperglycemia minimization algorithm will be running actively on the study laptop during the night and dose insulin if the algorithm predicts hyperglycemia. If hypoglycemia is predicted, the system will suspend the pump.
16023345|NCT02714959|Drug|Proleukin|
16023346|NCT02714946|Device|Percutaneous Laser Ablation|Single session with standardized approach: One or two fibers will be used for treatments including one to three illuminations with a fixed output power of 3 W, using the pullback technique. Energy for each emission will be 1200-1800J based on nodule volume. The treatment is performed under local anesthesia and conscious sedation.
16023347|NCT02714946|Device|Percutaneous Radiofrequency Ablation|Single session with standardized approach: A radiofrequency generator and a 17-gauge, 15-cm electrode with a 1-cm active tip will be used. A transisthmic approach along the short axis of the nodule will be used and the nodules will be managed with the moving-shot technique. 60 W of radiofrequency outpower will be used for all nodules. The treatment is performed under local anesthesia and conscious sedation
16023348|NCT02714933|Other|MRI sequence Advanced ZTE|Evaluation of the image quality in terms of visualization of anatomical structures of the lung parenchyma in safe zone by a new imaging method of the pulmonary parenchyma by MRI (Advanced ZTE sequence).
16023349|NCT02714920|Other|CHEMRAD assay|CHEMRAD is a new biomarker research strategy based on three assays that enables the functional characterization of DNA repair capacities.
16023350|NCT02714907|Device|Cortrium C3 device|Data is read from Cortrium C3 monitor
16023351|NCT02714907|Device|Holter device|Date is read from Holter device
16023352|NCT02714894|Drug|Clozapine|Patient participants will be starting clozapine as part of their clinical care.
16023353|NCT02714881|Drug|certolizumab|Subjects who are about to start TNFi therapy as part of usual therapy will be enrolled. In this study we will provide the drug, certolizumab.
16023354|NCT02714881|Radiation|Stress myocardial perfusion PET|We will measure coronary flow reserve (CFR) using cardiac PET before the patients starts TNFi and 24 weeks after starting TNFi.
16023355|NCT02714868|Behavioral|Project TEAM|Project TEAM is a manualized, group-based intervention designed to be co-facilitated by an experienced leader with a disability (disability advocate) and a licensed service provider (such as an occupational therapist, social worker, or educator). Project TEAM includes eight group sessions and two experiential learning field trips for each participant. Weekly phone calls with peer mentors with disabilities support achievement of each participant's personal activity goal.
16023356|NCT02714868|Behavioral|Matched Comparison|Participants set goal to try a new activity in the community
16023357|NCT02714855|Drug|Apixaban|
16023358|NCT02714842|Drug|Radiolabelled Diclofenac Tablet A|Delayed release diclofenac sodium tablet (50 mg)
16023359|NCT02714842|Drug|Radiolabelled Diclofenac tablet B|Delayed release diclofenac sodium tablet (50 mg)
16023360|NCT02714842|Drug|Radiolabelled Diclofenac tablet C|Delayed release diclofenac sodium tablet (25 mg)
16023361|NCT02714842|Drug|Diclofenac|Enteric coated delayed release diclofenac sodium tablet (50 mg)
16023362|NCT02714829|Device|Inject BMP|Injection of ExcelOS-inject(beta-TCP) containing rhBMP-2.
16023363|NCT02714829|Device|ExcelOS-inject|Injection of ExcelOS-inject(beta-TCP) without rhBMP-2.
16023364|NCT02714803|Behavioral|"Connective tissue massage and Conservative applications"|Connective tissue massage and conservative aplications were applied 5 days per week for a total of 10 sessions for 2 weeks.
16023365|NCT02714803|Behavioral|"Classic massage group and Conservative applications"|Classic massage and conservative aplications were applied 5 days per week for a total of 10 sessions for 2 weeks.
16023366|NCT02714803|Behavioral|"Sham massage group and Conservative applications"|Sham massage and conservative aplications were applied 5 days per week for a total of 10 sessions for 2 weeks.
16023367|NCT02714777|Device|Autonomic nervous system activity|Autonomic nervous system activity (parasympathetic activity) will be measured by electrocardiogram (holter) during 24 hours postoperative
16023368|NCT02714751|Behavioral|Daily asynchronies information|
16023369|NCT02714738|Procedure|Ultrasound guided peripheral nerve block|Ultrasound guided peripheral nerve block
16023370|NCT02714725|Drug|Dexmedetomidine|During bypass, patients will receive dexmedetomidine infusion 0.5 mcg/kg/hr
16023371|NCT02714725|Drug|Placebo for Dexmedetomidine normal saline infusion|During bypass, patients will receive normal saline infusion
16023372|NCT02714725|Drug|Propofol infusion|During bypass, patients will receive propofol infusion 50 - 70 mcg/kg/min
16023373|NCT02714712|Drug|Peginterferon alfa-2a|Peginterferon alfa-2a 180μg plus daily oral weight-based ribavirin (1,000 mg for body weight 75 kg or less, 1,200 mg for body weight greater than 75 kg) for 24 or 48 weeks
16023374|NCT02714699|Drug|diclofenac potassium|patients will take oral diclofenac potassium; two tablets (cataflam 25 mg) and one tablet placebo one hour before the procedure
16023375|NCT02714699|Drug|hyoscine butyl bromide|patients will take oral hyoscine-N- butyl bromide; 2 tablets (buscopan 10 mg) one hour before the procedure
16023376|NCT02714699|Drug|placebo|patients will take oral placebo; 2 tablets one hour before the procedure
16023377|NCT02714686|Behavioral|Radio Mass Media Family Planning Campaign|Short daily spots, weekly interactive shows, testimonies, and interviews with experts and community leaders on contraception and family planning
16023378|NCT02714673|Drug|anticoagulation|anticoagulation refers to any long term effective anticoagulation including antivitamin K, direct oral anticoagulants. Aspirin, clopidogrel are not included
16023379|NCT02714660|Other|none, observational study|
16023380|NCT02714647|Behavioral|Attentional prime|
16023381|NCT02714647|Behavioral|Sham prime|
16023382|NCT02714634|Drug|Methotrexate + biologic administration|"Methotrexate + adalimumab or
~Methotrexate + certolizumab or
~Methotrexate + etanercept or
~Methotrexate + golimumab or
~Methotrexate + infliximab or
~Methotrexate + abatacept or
~Methotrexate + rituximab or
~Methotrexate + tocilizumab"
16023383|NCT02714634|Drug|methotrexate + salazopyrine + hydroxychloroquine administration|
16023384|NCT02714621|Device|Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU)|
16023685|NCT02712554|Drug|M366|7.5 mg/325 mg tablet
16023686|NCT02712554|Drug|Placebo|
16023385|NCT02714608|Drug|Ginsenoside H dripping pills|Experimental: Ginsenoside H dripping pills. Dosage form:pill. Dosage :20pills ( only ginsenoside H dripping pills). Frequency:two times per day. Duration: until disease progression or death.
16023386|NCT02714608|Drug|Ginsenoside H dripping pills+Placebo|Experimental: Drug: Ginsenoside H dripping pills+Placebo. Dosage form:pill. Dosage :20pills ( ginsenoside H dripping pills 10 pills and placebo 10 pills). Frequency:two times per day. Duration: until disease progression or death.
16023387|NCT02714608|Drug|Placebo|Placebo Comparator: Placebo. Dosage form:pill. Dosage :20pills ( only placebo ). Frequency:two times per day. Duration: until disease progression or death.
16023388|NCT02714595|Drug|Cefiderocol|2 g intravenously over 3 hours every 8 hours for a period of 7 to 14 days, or 2 g every 6 hours for participants with creatinine clearance >120 mL/min.
16023389|NCT02714595|Drug|Best Available Therapy|Standard of care with either a polymyxin-based or non-polymyxin-based regimen as determined by the investigator and consisting of one to three marketed antibacterial agent(s).
16023390|NCT02714582|Behavioral|Bedside shift report|Bedside shift report is a process where shift-to-shift report between nurses is, if approved by the patient, executed at the patient's bedside in order to improve the patient's involvement (Anderson & Mangino 2006).
16023391|NCT02714569|Drug|LY3202328|Administered orally
16023392|NCT02714569|Drug|Placebo|Administered orally
16023393|NCT02714569|Drug|Atorvastatin|Administered orally
16023394|NCT02714569|Drug|Simvastatin|Administered orally
16023395|NCT02714556|Other|Physiologic measures of lung function|"Respiratory function tests:
~Nitrogen multiple breath washout (N2MBW) measured with an ultrasonic flowmeter (Exhalyzer D with ICU insert, Eco Medics, Duernten, Switzerland) Forced oscillation technique (FOT) measured with a tremoFlo device (Thorasys, Montreal, Canada)"
16023396|NCT02714543|Drug|aloevera juice|aloevera juice to drink twice daily for 3 months.
16023397|NCT02714543|Drug|Hydrocortisone|intralesional injection of hydrocortisone 100mg once a week for 6 weeks
16023398|NCT02714543|Drug|Hyaluronic Acid|injection hyaluronic acid 1500IU once a week for 6 weeks
16023399|NCT02714543|Drug|antioxidant|Capsules SM Fibro (antioxidants) once daily for 3 months.
16023400|NCT02714543|Drug|aloevera gel|aloevera gel one scoop to be applied 3-4 times daily for 3 months
16023401|NCT02714530|Drug|Erlotinib|Tarceva daily during radiotherapy course
16023402|NCT02714530|Radiation|Radiation|Radiotherapy
16023403|NCT02714517|Other|hydrotherapy|30 minutes sessions of physiotherapy exercises in heated pool (32°C), three times per week for four weeks
16023404|NCT02714517|Other|on land therapy|30 minutes sessions of physiotherapy exercises on land, three times per week for four weeks
16023405|NCT02714504|Drug|Voriconazole or posaconazole|Azole with activity against molds
16023406|NCT02714491|Other|Erigo + Music|"The patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with Erigo (3/week for 5 consecutive weeks) and musical stimulation."
16023407|NCT02714491|Other|Erigo + Metronome|"The patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with Erigo (3/week for 5 consecutive weeks) and metronome stimulation."
16023408|NCT02714491|Other|Erigo + Silence|"The patients receive daily conventional physiotherapy + fifteen 30-minutes stepping verticalization sessions with Erigo (3/week for 5 consecutive weeks), without auditory stimulation."
16023409|NCT02714478|Device|equistasi|3 devices will be placed in each patient: 1 at the spinosus process of L5; 1 at the insertion of transverse abdominis; 1 at the insertion of the gluteus medius to the femur. The devices will be kept for 55 minutes, during standard Physiotherapy
16023410|NCT02714478|Device|placebo|3 devices will be placed in each patient: 1 at the spinosus process of L5; 1 at the insertion of transverse abdominis; 1 at the insertion of the gluteus medius to the femur. The devices will be kept for 55 minutes, during standard Physiotherapy
16023411|NCT02714465|Other|hyperbaric oxygen therapy|hyperbaric oxygen therapy
16023412|NCT02714452|Behavioral|Person-centred care|Person-centred and thriving promoting care
16023413|NCT02714439|Drug|Proflavine|Proflavine 0.01% applied to the cervix before high-resolution microendoscopy imaging procedure performed.
16023414|NCT02714439|Procedure|High-Resolution Microendoscopy (HRME)|High-resolution microendoscopy imaging procedure performed after colposcopy exam. Standard colposcopy procedure will then continue. Entire HRME imaging procedure should add less than 10 minutes to the standard colposcopy exam.
16023415|NCT02714426|Behavioral|Mindfulness-inspired treatment|Eight weekly group MIT sessions lasting 90-120 minutes, along with a ½ day Mindfulness Retreat at the end of the training period, will include 1) psychoeducation, 2) formal exercises in the form of guided practice mentioned above, and 3) thoughtful exploration of ideas and questions. Formal MIT training will follow 21 guided pre-recorded meditative Moving Picture Experts Group Layer-3 Audio (MP3) tracks from the authors for use in class and at home, promoting both fidelity to the model and uniformity in intervention across training groups. MIT activities in the protocol include mindful breathing, eating, walking, and various other practices well documented in the literature to promote mindfulness. Participants will be asked to practice MIT on their own time, and to log this.
16023416|NCT02714426|Other|Brain health|Eight weekly group brain health sessions lasting 90-120 minutes. The intervention is psychoeducational, and each week presents information from NIH regarding factors that may promote cognitive health in late life (e.g., sleep, physical activity, social engagement and leisure, cognitive training). Weekly sessions are supplemented with educational videos and group discussion. Weekly homework consists of readings about brain health.
16023417|NCT02714413|Dietary Supplement|D-allulose|Subjects will be their own controls as they will be studied sequentially for the effects of varying amounts of D-allulose given in a random order associated with standardized oral sucrose load of 50 gms. In order to limit the possibility of carry-over effect, patients will be randomized to different treatment sequences. In each sequence all four doses (2.5, 5, 7.5, and 10 gm) and placebo will be present only one time and will be administered in a different order.
16023418|NCT02714413|Dietary Supplement|sucrose|All subjects will receive a standardized oral sucrose load of 50 gms
16023526|NCT02713659|Behavioral|Standard Literacy Promotion|Parents will receive weekly text messages about child safety, and no books before the age of 6 months from their provider. From 6 months of age, both groups will receive standard literacy promotion and will attend study visits every six months until age 2.
16023419|NCT02714413|Other|Placebo|Subjects will be their own controls as they will be studied sequentially for the effects of varying amounts of D-allulose given in a random order associated with standardized oral sucrose load of 50 gms. In order to limit the possibility of carry-over effect, patients will be randomized to different treatment sequences. In each sequence all four doses (2.5, 5, 7.5, and 10 gm) and placebo will be present only one time and will be administered in a different order.
16023420|NCT02714400|Drug|Venlafaxine|Venlafaxine 50mg before sleep
16023421|NCT02714400|Drug|Placebo|One piece of placebo before sleep
16023422|NCT02714387|Other|Collection of medical data|A code will be applied to each patient included. Medical data such as demography, Simplified Acute Physiological Score II (SAPS II), Sequential Organ Failure Assessment (SOFA), procedures and complications during ICU stay will be collected.
16023423|NCT02714374|Biological|GL-ONC1|"Dose and Regimen:
~Single dose group: Cohort 1 dose is 1 × 109 pfu
~Multiple dose groups:
~Cohort 2 dose is 1 × 109 pfu × 5 consecutive days
~Cohorts 3 and 4 dose is 2 × 109 pfu × 5 consecutive days
~Cohorts 5 and 6 dose escalates at 2,3,5,5,5 × 109 pfu.
~Route: GL-ONC1 is delivered as a bolus IV injection."
16023424|NCT02714361|Dietary Supplement|Vitamin D3 supplement|1500 IU (37.5 mcg) Vitamin D3 capsules daily over 8 weeks (56 days)
16023425|NCT02714361|Other|Placebo|65% olive oil capsules daily over 8 weeks (56 days)
16023426|NCT02714348|Other|Effect of helminth infection on vaccine immunogenicity|Observational; immunology
16023427|NCT02714322|Biological|MYL-1401A (Adalimumab)|MYL-1401A initial dose of 80 mg administered subcutaneously (sc), followed by 40 mg sc given every other week starting 1 week after the initial dose
16023428|NCT02714322|Biological|Humira® (Adalimumab)|Humira® initial dose of 80 mg administered sc, followed by 40 mg sc given every other week starting 1 week after the initial dose
16023429|NCT02714309|Dietary Supplement|Whey protein|20 g whey protein isolate (Arla Foods Ingredients Group) added to 200ml water and served as a beverage
16023430|NCT02714309|Other|Mixed macronutrient breakfast meal|A standardised mixed-macronutrient breakfast served to all participants. The macronutrient distribution of the breakfast is 13% protein, 70% carbohydrate, 17% fat (1958 kilojoules (kJ); 468 kcal total)
16023431|NCT02714309|Other|Ad libitum lunch meal|A mixed-macronutrient lunch served to all participants ad libitum. The macronutrient distribution of the lunch is 14% protein, 51% carbohydrate, 35% fat
16023432|NCT02714309|Other|Low/moderate intensity exercise|A 30 minute bout of treadmill walking is performed on a motorised treadmill at a low/moderate intensity (55% estimated VO2max)
16023433|NCT02714296|Drug|Nutridrink 200 ml|Nutridrink 200 ml 6 bottles per day as a sole source of nutrition. On the day of the colonoscopy, as breakfast, allowed Nutridrink 1-2 bottles
16023434|NCT02714296|Dietary Supplement|Nutridrink compact protein|2 bottles per day. On the day of the colonoscopy, as breakfast, allowed Nutridrink compact protein 1-2 bottles
16023435|NCT02714283|Drug|inhaled corticosteroid therapy|We will evaluate and compare the clinical effectiveness and safety of long-term inhaled corticosteroid and macrolide antimicrobial therapies
16023436|NCT02714283|Drug|macrolide therapy|We will evaluate and compare the clinical effectiveness and safety of long-term inhaled corticosteroid and macrolide antimicrobial therapies
16023437|NCT02714270|Procedure|modified partograph|
16023438|NCT02714270|Procedure|paperless partograph|
16023439|NCT02714257|Behavioral|Enhanced Usual Care plus Exercise Coaching|"For month one of the exercise intervention the investigators will conduct only strength and a few balance exercises to rehabilitate the participants. After the first month, and once the participants feel comfortable, the investigators will incorporate aerobic and additional balance exercises. The investigators will personalize participant programs based on baseline levels and increase them gradually. The exercise session will be conducted 50 minutes 3 times a week. Between sets there is a 60-second break.
~Every month the coach will record steps from the pedometer and record patient adherence to exercise sessions, and every 2 months the coach will measure strength and will track resistance band color from the exercise trackers.
~For the individuals exercising at home, the investigators will distribute the exercise Digital Versatile Disc (DVDs) every 9 months and the coach will continue to contact them, just as if they were joining the group. Coaches will encourage group participation."
16023440|NCT02714244|Other|Volume expansion|Volume expansion with rapid administration of 500 ml of crystalloid
16023441|NCT02714231|Drug|diclofenac sodium (cataflam)|The patients in the study group will take one tablet of cataflam 50 mg 30 min before the scheduled time of the procedure
16023442|NCT02714231|Drug|hyoscine butyl bromide (buscopan)|The patients in the study group will take one tablet of buscopan 10 mg 30 min before the scheduled time of the procedure
16023443|NCT02714218|Biological|Nivolumab 3 mg/kg IV|Followed by Nivolumab monotherapy
16023444|NCT02714218|Biological|Ipilimumab 1 mg/kg IV|Followed by Nivolumab monotherapy
16023445|NCT02714218|Biological|Nivolumab 1 mg/kg IV|
16023446|NCT02714218|Biological|Ipilimumab 3 mg/kg IV|
16023447|NCT02714218|Biological|Nivolumab 6 mg/kg IV|A dose of 240mg is identical to a dose of 3mg/kg, therefore 6mg/kg is approximately equal to ~ 480mg.
16023448|NCT02714205|Drug|transdermal nitroglycerin|Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
16023449|NCT02714205|Drug|Placebo|Study participants will be randomized to transdermal nitroglycerin patch or placebo patch. Participants will wear a study medication patch daily, for 12 weeks.
16023450|NCT02714192|Other|Exercise stress test (BCTT)|Participants are assessed for exercise tolerance using a treadmill with gradually increasing angle to increase workload. Stress test is stopped when there is symptom exacerbation or when participant experiences voluntary exhaustion.
16023451|NCT02714179|Drug|Paracetamol was given intravenously in both group at different times|
16023452|NCT02714166|Other|Sunscreen lotion SPF (Sun Protection Factor) 50 (BAY987521)|Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.
16023453|NCT02714166|Other|Ophthalmic Ointment|Study staff will administer the control in one eye and a test sunscreen in the other eye according to the assigned randomization schedule.
16023586|NCT02713191|Drug|Dexmedetomidine|Dexmedetomidine 1µg/Kg in 100 mL saline intravenously over 10-15 minutes immediately prior to procedure, followed by Dexmedetomidine infusion at 0.6 µg/kg/hour as maintenance dose during entire procedure
16023454|NCT02714153|Device|Bridge Balloon|The Bridge Balloon will be used in a non-emergent setting to allow for evaluation of how best to integrate this new technology into the investigators clinical practice. The study will focus on the effect of the Bridge balloon on the patient preparation clinical workflow, ease of insertion/positioning/deployment, and the ability to recognize proper inflation and vein sealing under fluoroscopy.
16023455|NCT02714140|Behavioral|PB-HCT +|Participants will be offered 3 HIV testing options. The investigators will rank the predicted utility of all EXISTING HIV testing options for each participant and select those 3 PB-HCT options that jointly maximize the share of participants predicted to prefer at least one of the three options over the common option.
16023456|NCT02714140|Behavioral|PB-HCT -|Participants will be offered 3 HIV testing options. The investigators will rank the predicted utility of all feasible HIV testing options for each participant and select 3 PB-HCT options that are less preferred than the common option
16023457|NCT02714140|Behavioral|Economic incentive|Participants will be re-contacted three months after being offered PB-HCT options. Participants will be reminded of the options, and offered an incentive to present for testing using any of the PB-HCT options or the common option.
16023458|NCT02714140|Behavioral|PB-HCT ++|Participants will be offered 3 HIV testing options. The investigators will rank the predicted utility of all feasible ENHANCED HIV testing options for each participant and select those 3 PB-HCT options that jointly maximize the share of participants predicted to prefer at least one of the three options over the common option.
16023459|NCT02714140|Behavioral|SMS Reminder|Participants will receive an SMS reminder to test.
16023460|NCT02714127|Other|First-void urine collection|One time collection of ca. 20ml of first-void urine (i.e. the initial stream of the urine void) with the Colli-PeeTM device (Novosanis).
16023461|NCT02714127|Other|Cervicovaginal lavage fluid collection|During colposcopy, the cervicovaginal region is rinsed for 2 minutes with 50 ml acetic acid (5%). This fluid is not discarded like it is done usually, but the remaining lavage fluid (5% acetic acid containing cervicovaginal fluid) will be collected.
16023462|NCT02714114|Other|First-void urine collection|One time collection of ca. 20ml of first-void urine (i.e. the initial stream of the urine void) with the Colli-PeeTM device (Novosanis).
16023463|NCT02714114|Other|Blood draw|One time blood sample collection (5-10 cc) by a study nurse of Centre for the Evaluation of Vaccinations (CEV).
16023464|NCT02714101|Other|Equine assisted occupational therapy|Intervention was one 40 to 60 minute session per week. Half of the session was spent riding a horse and half was spent doing horse related activities. Children had 9 to 12 sessions
16023465|NCT02714088|Other|Novel high-intensity interval training|
16023466|NCT02714075|Other|Ferric Pyrophosphate and Zinc Oxide|Extruded rice fortified with Ferric Pyrophosphate, Zinc Oxide (ZnO) and micronutrients
16023467|NCT02714075|Other|Ferric Pyrophosphate and Zinc Sulphate|Extruded rice fortified with Ferric Pyrophosphate, Zinc Sulphate (ZnSO4) and micronutrients
16023468|NCT02714075|Other|Ferric Pyrophosphate, ZnO, Citric Acid and Trisodium Citrate|Extruded rice fortified with Ferric Pyrophosphate, Zinc Oxide (ZnO), Citric Acid (CA) and Trisodium Citrate (TSC) and micronutrients
16023469|NCT02714075|Other|Ferric Pyrophosphate, ZnSO4, CA/TSC|Extruded rice fortified with Ferric Pyrophosphate, ZnSO4, CA/TSC and micronutrients
16023470|NCT02714075|Other|Ferric Pyrophosphate, ZnO, CA, EDTA|Extruded rice fortified with Ferric Pyrophosphate, ZnO, CA, EDTA and micronutrients
16023471|NCT02714075|Other|Ferrous Sulphate|Extruded rice fortified with micronutrients, Ferrous Sulphate solution will be added at consumption
16023472|NCT02714062|Drug|Placebo|po once daily
16023473|NCT02714062|Drug|VI-0521 Mid Dose|po once daily
16023474|NCT02714062|Drug|VI-0521 Top Dose|po once daily
16023475|NCT02714049|Behavioral|sex therapy|60 minutes each time, in person or on the telephone
16023476|NCT02714049|Drug|flibanserin|FDA approved medication for treatment of hypoactive sexual desire disorder in premenopausal women
16023477|NCT02714036|Drug|ibudilast|Ibudilast is a small molecule that crosses the blood-brain barrier after oral administration16. Its potential as a neuroprotective agent is based on in vitro and in vivo evidence of its ability to reduce microglial activation, inhibit microglia-monocyte recruitment to the central nervous system (CNS), and trigger the release of neurotrophic factors.
16023478|NCT02714023|Procedure|Normal Saline|Intra-operative irrigation with normal saline
16023479|NCT02714023|Procedure|Sterile Water|Intra-operative irrigation with sterile water
16023480|NCT02714010|Drug|EGFR-TKI|Gefitinib 250mg po qd or Tarceva 150mg po qd or Icotinib 125mg po tid
16023481|NCT02714010|Radiation|whole brain radiotherapy|30Gy/10F
16023482|NCT02713997|Drug|etanercept|50 mg on day 0 SQ; 25 mg subcutaneous (SQ) on days 3, 7, 10, 14, and 21 relative to TPIAT
16023483|NCT02713997|Drug|Alpha 1-Antitrypsin|90 mg/kg intravenous infusion on days -1, and +3, 7, 14, 21, and 28 post-transplant
16023484|NCT02713984|Biological|Anti-HER2 CAR-T|HER-2-targeting CAR-T cells infusion in HER2 positive cancers
16023485|NCT02713971|Device|Gamepad system|Patients executed a set of tailored exercises including the control of weight-shift and body posture during static (e.g. upright sitting and standing), quasi-dynamic (e.g. sit-to-stand and gait initiation) and dynamic tasks (e.g. getting on a step, straight-line walking, walking with turns and over obstacles). Participants executed the tasks using Gamepad system which provided patients with visual and auditory feedback about their performances and assigned a score at the end of each exercise. The physiotherapist progressively adjusted training complexity by changing the reference values, including more difficult taks, changing the perceptive context, and/or including a dual-task.
16023486|NCT02713971|Other|Conventional physiotherapy|A set of tailored exercises was defined by the clinical staff following current guidelines for physiotherapy in Parkinson's disease. In particular, stretching, joint mobilization, and balance and gait exercises were provided to participants, without any instrumentation producing biofeedback or external cues.
16023487|NCT02713958|Other|Telerehabilitation|Telerehabilitation: Telerehabilitation treatment using a computerized system (MediTouch) for improving the elbow motion
16023488|NCT02713958|Other|Rehabilitation|Traditional Occupational Therapy treatment: Active exercises for elbow motion
16023489|NCT02713945|Drug|Simvastatin|Experimental drug administrated orally
16023490|NCT02713945|Drug|Placebo|Treatment for the control group
16023491|NCT02713932|Device|Transcatheter aortic valve implantation|
16023492|NCT02713919|Behavioral|Adapted German PRO-SELF© Plus Pain Control Program|Two in-home visits (60 minutes) with at least weekly follow-up (visit or telephone call according to algorithm): Structured and tailored components; review of pain diary with participant, provision of information on pain medication, nurse coaching regarding pain self-management, detailed side-effect management plan, if distressing side-effects arise, re-evaluation together with participant at each subsequent visit.
16023493|NCT02713906|Device|X-Ray Knee Guide group|
16023494|NCT02713893|Drug|Econazole nitrate 1% plus Benzydamine HCl 0.12% intravaginal cream|
16023495|NCT02713893|Drug|Placebo plus Econazole nitrate 1% intravaginal cream|
16023496|NCT02713893|Drug|Placebo plus Benzydamine HCl 0.12% intravaginal cream|
16023497|NCT02713893|Drug|Placebo intravaginal cream|
16023498|NCT02713867|Biological|Nivolumab|
16023499|NCT02713854|Procedure|endometrial biopsy|An endometrial biopsy taken 2-3 months prior to IVF cycle
16023500|NCT02713841|Drug|inhaled human insulin (INH)|recombinant human insulin administered with Adagio-01 inhaler device
16023501|NCT02713841|Drug|sc insulin lispro (LIS)|insulin lispro administered subcutaneously
16023502|NCT02713828|Drug|Phase I: Glembatumumab Vedotin|"Escalation Phase: Three to 6 patients will be enrolled in each dose cohort based on a standard Phase I dose escalation scheme. For the dose-escalation, the starting dose of glembatumumab vedotin will be 1.9 mg/kg q3w (Cohort 1). In the event of ≥ 2 DLTs, the dose will de-escalate to Cohort -1 (1.3 mg/kg).
~Dose escalation from Cohort 1 to Cohort 2 (2.2 mg/kg) may proceed if three patients in Cohort 1 complete the DLT observation period with 0 DLTs, or if six patients in Cohort 1 complete the DLT observation period with 0 or 1 DLTs."
16023503|NCT02713828|Drug|Phase II: Glembatumumab Vedotin|In Stage 1, approximately 20 eligible, treated patients will be enrolled. If ≥ 2 patients achieve a tumor response (Partial Response [PR] or Complete Response [CR]), an additional 15 eligible, treated patients will be enrolled in Stage 2, for a maximum total of 35 eligible, treated patients.
16023504|NCT02713815|Radiation|repetitive transcranial magnetic stimulation (rTMS)|Stimulate the dorsomedial prefrontal cortex for 4 weeks by Theta-burst stimulation (TBS), once a day
16023505|NCT02713815|Radiation|sham repetitive transcranial magnetic stimulation (rTMS)|Stimulate the dorsomedial prefrontal cortex for 4 weeks by sham Theta-burst stimulation (TBS), once a day
16023506|NCT02713802|Drug|Cudafol(R) (propofol, 1% [10 mg/mL])|Test product Cudafol(R) to be administered via 1 mg/kg bolus injection, then continuous infusion at 50 ug/kg/min for 15 minutes
16023507|NCT02713802|Drug|Diprivan(R) (propofol, 1% [10 mg/mL])|Reference product Diprivan(R) to be administered via 1 mg/kg bolus injection, then continuous infusion at 50 ug/kg/min for 15 minutes
16023508|NCT02713789|Drug|hMaxi-K Single Treatment/ 2 escalating dose levels (8000 µg and 16000 µg injection)|
16023509|NCT02713789|Drug|Placebo (PBS-20% sucrose)|
16023510|NCT02713776|Drug|Pasireotide|Pasireotide 0.9 mg by subcutaneous injection twice a day during 3 days and 1 intramuscular injection of pasireotide Long Acting Release (LAR) 60mg on Day 4 morning.
16023511|NCT02713776|Drug|Placebo|Placebo by subcutaneous injection twice a day during 3 days and 1 intramuscular injection of placebo on Day 4 morning.
16023512|NCT02713763|Drug|Sunitinib|Sunitinib 37.5 mg/day
16023513|NCT02713750|Other|reversible contraceptive methods|"Consistent male condom use only
~Consistent female condom use only
~Hormonal contraception, combined oral contraceptive pills and male/female condom
~Hormonal contraception, progestin only depot medroxyprogesterone acetate (DMPA) injectable and male/female condom
~Hormonal contraception , progestin only hormonal implant and male/female condom
~Intrauterine device and male/female condom"
16023514|NCT02713737|Device|heated humidified high-flow nasal cannula|HFNC device (Airvo™, Fisher＆Paykel, Auckland, New Zealand) with a heated circuit (Fisher＆Paykel,900PT501) and nasal cannula(optiflow TM,Fisher＆Paykel). It has adjustable FiO2: 21%-100%, gas flow up to 60 L/min, to maintain arterial blood hemoglobin oxygen saturation ( SPO2) > 92%.
16023515|NCT02713737|Device|noninvasive ventilation|TBird VELA ventilator, CareFusion, USA. Pressure adjustments were to optimize patient comfort. Inspiratory pressure was raised every 5 mins until comfort was optimized. FiO2 was adjusted to maintain SPO2 > 92%.
16023516|NCT02713724|Behavioral|physical exercise|DAPS-group will follow a personal adjusted training program including instructions from a personal trainer Standard-group will receive a membership at a gym but limited instructions
16023517|NCT02713724|Behavioral|limited physical exercise|The standard group will receive a membership at a gym but limited instructions and no access to a personal trainer
16023518|NCT02713711|Radiation|phototherapy|Twelve sessions of phototherapy (UV-B) according to individual initial evaluation of Minimal Erythema Dose (MED).
16023519|NCT02713711|Procedure|balneotherapy|Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L).
16023520|NCT02713711|Procedure|balneophototherapy|Twelve sessions of both balneotherapy and phototherapy treatments.
16023521|NCT02713698|Drug|Propofol|"The whole anaesthetic procedure is standard except for additional body composition assessment with Body Composition Monitor - BCM (Fresenius Medical Care, Germany) and arterial blood samples collection.
~In all included patients, propofol will be started at 2000mg/h until LOC, defined by loss of eye-lash reflex and loss of response to name calling. During surgery propofol infusion will be guided by targeted BIS values between 40 and 60.
~Arterial blood samples will be obtained immediately after LOC and after every 20-30 minutes during propofol infusion. After stopping propofol infusion, arterial blood samples will be acquired every 10 minutes until recovery of consciousness. The maximum blood sample per patient will be 20 mL."
16023522|NCT02713685|Procedure|Subarachnoid block|Subarachnoid block will be given using 2.5 ml of 0.5%Bupivacaine for lower limb anesthesia
16023523|NCT02713685|Procedure|combined Femoral and Sciatic nerve block|Femoral and Sciatic nerve blocks will be given using total 40 ml of 0.25%of Bupivacaine to anesthetise for lower limb surgery
16023524|NCT02713672|Other|Dose adjustment according to genotype|Patients in the intervention group received a dose adjustment according to their CYP2D6 or CYP2C19 genotype based on guidelines of the KNMP
16023525|NCT02713659|Behavioral|Early Literacy Promotion|Parents will receive a book with developmentally appropriate advice about reading at each well child visit from one week through 5 months of age, as well as weekly text reminders related to reading. From 6 months of age, both groups will receive standard literacy promotion and will attend study visits every six months until age 2.
16023687|NCT02712528|Drug|remifentanil-based|
16023527|NCT02713633|Other|internal Double-J stents|internal stent, we use to approaches to insert it: 1- Retrograde by cystoscopy and this will take 10 minutes before starting the surgical procedure itself and we put the stent under fluoroscopy guidance and this is the commonest way we use now to put the internal stents. 2- ante grade, and this is basically inserting the stent during the surgical procedure itself from the kidney down to the ureter and this is done without fluoroscopy
16023528|NCT02713633|Other|External Stent|we use one method, we choose were we will leave the stent and then we create a small hole in the kidney and then pull the stent through the hole and then create small hole in the abdominal fascia and then the skin, all this done under direct vision and control. So now the sent is outside the patient and connected directly to the kidney and the renal pelvis, then the distal part of the stent will be inserted across the anastomosis and before closing the renal pelvis (also under vision) toward the ureter. The external stent will be connected at the end of the procedure to a urine bag.
16023529|NCT02713620|Biological|recombinant HBV vaccine (Hepavax-Gene® Berna, Korea)|Different HBV vaccine regimen in each group
16023530|NCT02713607|Drug|Doxycycline|Given doxycycline to acne subjects
16023531|NCT02713594|Behavioral|Counseling from WTQL|Counseling from the Wisconsin Tobacco Quit Line (WTQL) consisted of 5 proactive calls to the participant to help them successfully quit tobacco use, plus ad hoc calls at the participant's initiation; also, WTQL coaches encouraged participants to see their health care provider to obtain Medicaid-approved smoking cessation medications to help them quit smoking.
16023532|NCT02713594|Other|Financial incentive to participate|Participants in the Incentive condition received $30 per call for up to five WTQL calls taken; in addition, Incentive condition participants received $40 for producing biochemical evidence of abstinence at the 6-month follow-up visit. (Note that participants in both the Control condition and the Incentive condition received $40 for completing the baseline biochemical smoking status assessment visit and $40 for completing the 6-month follow-up biochemical smoking status assessment visit.) Compensation was in the form of prepaid Visa gift cards mailed approximately 2-4 weeks after the point of contact.
16023533|NCT02713581|Biological|Blood sampling|Venous blood will be sampled for laboratory analyses (see outcomes).
16023534|NCT02713568|Other|Ultrasound examination|"Prenatal Ultrasound examinations will be carried out using transabdominal sonography only by experienced consultants in MFM. Ultrasound-Estimated Fetal Weight will be obtained between 36.0-36.6 weeks of gestation, according to Hadlock et al.
~Operators performing the Ultrasound-Estimated Fetal Weight will be blinded to the results of Magnetic Resonance-Estimated Fetal Weight. The participants, general practitioners, obstetricians and midwifes of the patients will be aware of the results of Ultrasound-Estimated Fetal Weight which will be used for clinical management.
~For the primary outcome measure, macrosomia during Ultrasound-Estimated Fetal Weight will be defined as ≥ P95 based on Yudkin et al. For secondary outcome measures, it will be redefined as ≥ P90 or ≥ P99 based on Yudkin."
16023535|NCT02713568|Other|Magnetic resonance examination|"MRI will be performed the same day as the Ultrasound examination, using a clinical 1.5T whole-body unit.
~Operators performing Fetal Body Volume measurements will be blinded from Ultrasound-Estimated Fetal Weight results. Magnetic Resonance-Estimated Fetal Weight will be calculated using the equation 0,12+1,031*Fetal Body Volume = MR imaging weight (g) developed by Baker.
~General practitioners, obstetricians and midwifes of the patients will be blinded to the results of the Magnetic Resonance-Estimated Fetal Weight.
~For the primary outcome measure, macrosomia will be defined as ≥ P95 based on Yudkin et al. For secondary outcome measures, it will be defined as ≥ P90 or ≥ P99."
16023536|NCT02713555|Procedure|Roux-en-Y Gastric Bypass|Roux-en-Y Gastric Bypass surgery entails the formation of a small gastric pouch and the division of the small intestine 60 cm from the duodenum. Formation of a gastrojejunal anastomosis with the distal segment and the formation of a jejuno-jejunal anastomosis 150 cm from the gastrojejunal anastomosis with the biliary segment.
16023537|NCT02713555|Procedure|Gastric Sleeve|Gastric Sleeve entails a vertical division of the stomach with a stapler.
16023538|NCT02713542|Device|ACP|Autologous Conditioned Plasma
16023539|NCT02713542|Other|Placebo|Three Normal Saline IA injections of 3-8 mL at 1-week intervals.
16023540|NCT02713529|Biological|AMG820 and pembrolizumab|Treatment with AMG820 and pembrolizumab
16023541|NCT02713516|Other|Virtual Reality|Use of virtual reality to deliver exposure therapy
16023542|NCT02713503|Other|Driving Observation|Driving observation using the DriveSafety CDS-250 Driving Simulator.
16023543|NCT02713503|Other|VisionCoach|Visual field evaluation using VisionCoach
16023544|NCT02713490|Drug|EXPAREL|EXPAREL and bupivacaine HCl
16023545|NCT02713490|Drug|Bupivacaine|Single dose of bupivacaine HCl 0.5%
16023546|NCT02713477|Drug|Insulin glargine/ lixisenatide fixed-ratio combination HOE901/AVE0010|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
16023547|NCT02713477|Drug|Insulin glargine HOE901|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
16023548|NCT02713477|Drug|Placebo|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
16023549|NCT02713464|Behavioral|maternal education|Antenatal and/or postpartum Instruction on risks of neonatal jaundice, dangerous practices, technique to evaluate jaundice, early signs of ABE, when to seek care.
16023550|NCT02713451|Drug|Modulation of Inspired Fraction of Oxygen (FiO2)|"In the two groups, if patient is not in the range of arterial oxygen pressure (PaO2), Inspired Fraction of Oxygen (FiO2) will be modified from 5 percent if difference between target is less than 5 mmHg and from 10 percent if difference from target is higher. A new arterial blood gases (ABG) will be performed 30 minutes later to check for the oxygen target range. When ABG are performed, pulsed oxymetry is compared with arterial saturation (SaO2) to adapt survey. Between each ABG, FiO2 is modified from 5 percent to 5 percent each five minutes until reaching good pulsed oxygen saturation (SpO2) target (that can be modified in function of the comparison of arterial oxygen saturation (SaO2 and SpO2 with ABG).
~This management of FiO2 will be done until extubation of the patient."
16023587|NCT02713191|Drug|Midazolam bolus|Midazolam 2 mg as slow intravenous bolus immediately prior to procedure
16023588|NCT02713191|Other|Saline placebo|100 mL saline infusion over 10-15 minutes immediately prior to procedure
16023589|NCT02713191|Drug|Rescue midazolam|Rescue boluses of 0.5 mg midazolam, if needed during procedure
16023590|NCT02713191|Drug|Fentanyl|1 µg/kg fentanyl as slow intravenous bolus immediately prior to procedure
16023688|NCT02712528|Drug|sevoflurane-sufentanil balanced|
16112938|NCT02066298|Drug|Placebo|
16023551|NCT02713438|Behavioral|Individual Planning|"CONTENT: The planning materials and forms have sections: (a) information on the importance of planning, including examples of how planning works and what it affects, (b) instructions of what should be included in a good plan (the when, where, and how components), (c) formulating action and coping plans. Action plans (referring to when, when, and how the individual will act) as well as coping plans (referring to how to overcome potential difficulties, risky situations or temptations to not engage in physical activity).
~Each participant forms their plans individually, without consulting the dyadic partner, but discussing the plans with the experimenter."
16023552|NCT02713438|Behavioral|Dyadic Planning|"CONTENT: The planning materials and forms have sections: (a) information on the importance of planning, including examples of how planning works and what it affects, (b) instructions of what should be included in a good plan (the when, where, and how components), (c) formulating action and coping plans. Action plans (referring to when, when, and how the individual will act) as well as coping plans (referring to how to overcome potential difficulties, risky situations or temptations to not engage in physical activity).
~Both partners in the dyad jointly form one plan. This jointly developed plan is discussed with the experimenter. The plan focuses on physical activity of only one person in the dyad: the child (parent-child dyads)."
16023553|NCT02713438|Behavioral|Collaborative Planning|"CONTENT: The planning materials and forms have sections: (a) information on the importance of planning, including examples of how planning works and what it affects, (b) instructions of what should be included in a good plan (the when, where, and how components), (c) formulating action and coping plans. Action plans (referring to when, when, and how the individual will act) as well as coping plans (referring to how to overcome potential difficulties, risky situations or temptations to not engage in physical activity).
~Both partners in the dyad jointly form one plan. This jointly developed plan is discussed with the experimenter. The plan focuses on physical activity of both persons within the dyad (parent and child) and include some plans for joint physical activity."
16023554|NCT02713438|Behavioral|Education|"CONTENT: The education materials address physical activity and healthy nutrition guidelines for age groups. Participants receive a set of educational materials about types of physical activity (PA), PA intensity, exercise calorie expenditure, strength and endurance training, stretching, and general nutrition guidelines in terms of meal composition, and nutrients, meal frequency. The materials exclude any planning statements.
~The education is delivered by the experimenter to a parent-child dyad and discusses individual guidelines for both dyadic partners."
16023555|NCT02713425|Device|Entertaining Video Game|Children between 7 & 17 with a social anxiety disorder will be invited to participate in this study. They will attend a single visit. During the visit they will use the therapeutic game. They will be monitored while using the game. After the completion, they will be asked questions regarding their experience with this therapeutic game.
16023556|NCT02713412|Other|Glucose|75g glucose and 150 mg of 13C-acetate made up to 300 ml with water
16023557|NCT02713412|Other|Water|300ml water
16023558|NCT02713399|Device|Optical Coherence Tomography|
16023563|NCT02713373|Biological|Cetuximab|Given IV
16023564|NCT02713373|Other|Laboratory Biomarker Analysis|Correlative studies
16023565|NCT02713373|Biological|Pembrolizumab|Given IV
16023566|NCT02713360|Behavioral|Cognitive Therapy|
16023567|NCT02713347|Behavioral|ADAPT Intervention|"The intervention includes 3 components:
~nurse (RN) follows structured algorithms to help patients with symptoms, specifically breathlessness, fatigue, and pain.
~social worker provides structured counseling targeting adjustment to illness and depression and advance care planning.
~collaborative care model of care delivery, in which the nurse and social worker meet weekly with a primary care provider and palliative care specialist. This team makes medical recommendations to the intervention subjects' providers and supervises the nurse and social worker. The team has as-needed consultation with a cardiologist or pulmonologist. The nurse and social worker visits are in-person or by phone."
16023568|NCT02713334|Behavioral|survey|
16023569|NCT02713334|Behavioral|semi-structured interview|
16023570|NCT02713282|Drug|Paliperidone palmitate 3 month formulation (PP3M)|Participants will receive intramuscular injection of Paliperidone Palmitate 3-Month Formulation (PP3M) on Day 1 at a starting dose of 175 milligram equivalent (mg eq) up to 525 mg eq based on last Paliperidone Palmitate 1-Month Formulation (PP1M) dose (at a dose of 3.5-fold multiple of the participant's last PP1M dose). Subsequent PP3M injections will be given at Month 3, Month 6, and Month 9 and dose can be adjusted flexibly in increments within the range of 175 to 525 mg eq.
16023571|NCT02713269|Procedure|Computed Tomography|Undergo CT scan
16023572|NCT02713269|Other|Quality-of-Life Assessment|Ancillary studies
16023573|NCT02713269|Other|Questionnaire Administration|Ancillary studies
16023574|NCT02713269|Radiation|Stereotactic Radiosurgery|Undergo CT-guided SSRS
16023575|NCT02713269|Procedure|Thermal Ablation Therapy|Undergo thermal ablation therapy
16023576|NCT02713256|Drug|CFZ533|CFZ533 intravenously over approximately one hour
16023577|NCT02713243|Drug|LJN452|Capsules containing LJN452
16023578|NCT02713243|Drug|Placebo to LJN452|Capsules containing placebo to LJN452
16023579|NCT02713230|Drug|bupivacaine liposome injectable suspension|10 mL EXPAREL (bupivacaine liposome injectable suspension) expanded with 10 mL normal saline
16023580|NCT02713230|Drug|bupivacaine liposome injectable suspension|20 mL EXPAREL (bupivacaine liposome injectable suspension)
16023581|NCT02713230|Drug|Placebo|20 mL normal saline as single-injection
16023582|NCT02713217|Other|Usual Care|This condition is defined as usual care occurring within Community Based Outpatient Clinics (CBOCs), which typically does not involve substantial integration of mental health care and primary care.
16023583|NCT02713217|Other|Blended Telemedicine-Based Integrated Care|"This condition involves exposure to a blended collaborative care model that includes care management for depression and alcohol disorders and virtual co-location of doctoral-level mental health providers with prompt access through tele-video or telephone communication."
16023584|NCT02713204|Drug|REGN910-3|
16023585|NCT02713204|Drug|Intravitreal Aflibercept Injection (IAI)|
16023638|NCT02712853|Other|Saliva collection|Collection of saliva via swab for miRNA processing
16023591|NCT02713178|Drug|bupivacaine liposome injectable suspension|bupivacaine liposome injectable suspension 133 mg expanded with normal saline to 20 mL or 266 mg in 20 mL
16023592|NCT02713178|Drug|Placebo|Normal saline.
16023593|NCT02713165|Other|Raisins|Participants will consume 84g of raisins per day for 14 days.
16023594|NCT02713139|Drug|Clotrimazole + Metronidazole|Vaginal cream with Clotrimazole 200mg and Metronidazole 0,75%. Apply once per day, before bedtime, for 5 (five) days.
16023595|NCT02713139|Drug|Metronidazole|Vaginal gel with Metronifdazole 100mg/g. Apply once per day, before bedtime, for 10(ten) days.
16023596|NCT02713139|Drug|Clotrimazole|Vaginal cream with Clotrimazole 20mg/g. Apply once per day, before bedtime, for 3 (three) days.
16023597|NCT02713126|Drug|Placebo Solution|Placebo capsule administered orally, taken every 4 hours or 3 times per day during waking hours for 12 weeks
16023598|NCT02713126|Drug|Oral Sodium Nitrite|Oral Sodium Nitrite, 40 mg administered orally, taken every 4 hours or 3 times per day during waking hours for 12 weeks
16023599|NCT02713126|Device|Accelerometer|External triaxial accelerometer is worn externally at the hip during exercise training sessions, and day/night to continuously measure activity levels, removed for bathing only.
16023600|NCT02713126|Other|Cardiac Exercise Training|Cardiac rehabilitation exercise training consisting of supervised endurance and strength exercise training of approximately one hour, 3 times per week for 12 weeks.
16023601|NCT02713113|Drug|sugammadex reversal of neuromuscular blockade|
16023602|NCT02713100|Behavioral|level of agitation|psychological pain
16023603|NCT02713087|Drug|Ephedrine|Infusion of Ephedrine 2mg/ml until MAP above 60 mmHg or until MAP has raised 20%
16023604|NCT02713087|Drug|Phenylephrine|Infusion of Phenylephrine 0,1mg/ml until MAP above 60 mmHg or until MAP has raised 20%
16023605|NCT02713074|Drug|povidone-iodine|The patients will be subjected to povidone-iodine (Betadine7.5%) for vaginal cleaning before office hysteroscopy
16023606|NCT02713074|Drug|normal saline|The patients will be subjected to normal saline (Sod. Chloride 0.9%, Nile) for vaginal cleaning
16023607|NCT02713061|Drug|TAK-850|TAK-850 injection
16023608|NCT02713048|Other|Blood sample collection|Eight blood samples in each patient within 48 hours to perform Troponin I measurement.
16023609|NCT02713035|Behavioral|Self help intervention|For participants randomized to receive the treatment, the self-help intervention will be briefly described by a member of the clinical staff, and a brief pamphlet will be distributed to the parent or guardian at the end of the visit. The pamphlet describes behavioral strategies for coping with and reducing scratching behaviors. Participants randomly selected to not receive the treatment will not receive the pamphlet at the end of the visit.
16023610|NCT02713022|Device|DEXA Scan|
16023611|NCT02713022|Behavioral|Godin Leisure Time Exercise Questionnaire (GLTEQ)|
16023612|NCT02713009|Dietary Supplement|Pregnancy multi-vitamin (including 10μg vitamin D3)|
16023613|NCT02713009|Dietary Supplement|10μg vitamin D3|
16023614|NCT02713009|Dietary Supplement|0μg vitamin D (placebo)|
16023615|NCT02712996|Drug|Lisdexamfetamine|Lisdexamfetamine (Vyvanse) capsule, 20-70 mg, each morning for 6 weeks.
16023616|NCT02712996|Drug|Placebo|Placebo capsule, 20-70 mg, each morning for 6 weeks.
16023617|NCT02712983|Drug|TIP|TIP dose regimen
16023618|NCT02712983|Drug|TIP and placebo|TIP and inhaled placebo dose regimen
16023619|NCT02712983|Drug|Placebo|Inhaled placebo dose regimen
16023620|NCT02712970|Procedure|pit-picking technique|midline pits were excised removing a minimal amount of tissue (with a margin of skin of <1 mm). Incision of 1-2 cm in length was performed parallel to the most convenient side of the midline to be curetted of the chronic abscess cavity. All infected granulation tissue and hair were removed. After establishing hemostasis, the area of the excised midline pits was approximated by absorbable sutures.
16023621|NCT02712970|Procedure|Bascom Cleft Lift|The upper end of the incision was made 1-2 cm lateral to the midline on the more affected side and this was continued vertically over a distance of 1-2 mm from the midline pits. The lower end was fashioned from the midline in a V-shape in order to prevent a dog-ear deformity. The skin on this side of the natal cleft was then elevated and excised. The skin on the opposite side was undermined to the distance required to allow primary closure of the defect away from the midline without tension. Sinus tissue and its extensions were excised. The incision was then closed subcuticularly by absorbable polyglecaprone (3-0), after which a few interrupted mattress polyglecaprone (3-0) buttress sutures were also inserted.
16023622|NCT02712970|Procedure|Rhomboid excision with the Limberg Flap|The area to be excised was mapped on the skin in a rhomboid form, and the flap was designed. The skin incision was deepened to the postsacral fascia. The flap was fully mobilized and transposed medially to fill the defect without tension. The wound was closed in two layers: the subcutaneous tissue with absorbable (2/0 polyglactin) sutures and the skin with nonabsorbable (3/0 polypropylene) interrupted mattress suture
16023623|NCT02712970|Procedure|Other flap techniques|Bascom Cleft lift as described above, Rhomboid excision with the Limberg Flap as described above, V-Y advancement flap, Z-Plasty
16023624|NCT02712957|Drug|NEO6860|TRPV1 antagonist
16023625|NCT02712957|Drug|NEO6860 placebo|Inactive substance
16023626|NCT02712957|Drug|Naproxen|NSAID
16023627|NCT02712957|Drug|Naproxen placebo|inactive substance
16023628|NCT02712944|Drug|Testosterone|Testosterone
16023629|NCT02712944|Drug|Saline|Placebo
16023630|NCT02712918|Behavioral|Brief Behavioral Activation Treatment for Depression|Behavioral treatment of depression which focuses on increasing the Level of positive reinforcement through systematic and goal directed activation of behavior. Goal and values are assessed and used to determine target behaviors.
16023631|NCT02712918|Other|Standard Care|Treatment as usual at the ward
16023632|NCT02712905|Drug|INCB059872|"Initial cohort dose of INCB059872 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose(s) will be taken forward into expansion cohorts.
~INCB059872 tablets to be administered by mouth."
16023633|NCT02712905|Drug|all-trans retinoic acid (ATRA)|
16023634|NCT02712905|Drug|azacitidine|
16023635|NCT02712905|Drug|nivolumab|
16023636|NCT02712892|Genetic|Non Interventional Study|
16023637|NCT02712866|Drug|Vedolizumab|Administration of intravenous Vedolizumab in inflammatory bowel disease patients
16023640|NCT02712840|Procedure|Freeze-All Protocol|All good morphologic quality blastocysts are vitrified on day 5 or 6. The best quality vitrified blastocyst frozen on day 5 will be warmed and transferred in a subsequent cycle.
16023641|NCT02712840|Procedure|Fresh Protocol|Participants receive fresh embryo transfer of best morphologic quality blastocyst on day 5 and vitrification of all good quality supernumerary blastocysts.
16023642|NCT02712827|Procedure|Progrip|Self-fixating mesh
16023643|NCT02712827|Procedure|Non-Progrip|Non self-fixating mesh with the use of glue
16023644|NCT02712814|Drug|Topical hormonal cream (estrogen)|Patients will be instructed to stop hormonal contraception and to apply 0.1 ml topical cream containing 0.1% of estriol to the vestibule, once daily for 3 months
16023645|NCT02712814|Procedure|Pelvic floor physical therapy|PF physical therapy once weekly for 3 months
16023646|NCT02712814|Procedure|Low Level Laser therapy|non-thermal laser irradiation (low levels of red and near infrared light) is applied directly to the vestibule
16023647|NCT02712801|Drug|Zidovudine|Dose will be adjusted according to the child's weight.
16023648|NCT02712801|Drug|Nevirapine|Dose will be adjusted according to the child's weight.
16023649|NCT02712801|Drug|Lamivudine|Dose will be adjusted according to the child's weight.
16023650|NCT02712801|Drug|Lopinavir/ritonavir|Dose will be adjusted according to the child's weight.
16023651|NCT02712788|Drug|Milrinone|
16023652|NCT02712788|Drug|Placebo|
16023653|NCT02712775|Drug|Minocycline (yes/no)|
16023654|NCT02712775|Drug|Placebo|Saline
16023655|NCT02712762|Other|Cross-sectional study|
16023656|NCT02712749|Device|Sound with Binaural Beats|Acoustic frequencies of 256 Hz in one ear and 260 Hz in the opposite ear producing a binaural beat of 4 Hz generated by the special program Gnaural in stereo option
16023657|NCT02712749|Device|Sound without Binaural Beats|Acoustic frequencies of 256 Hz in both ears to perceive one tone without beats generated by the program Gnaural in mono option
16023658|NCT02712736|Other|quality of life survey|subjects with PSC will be administered a survey to assess their quality of life
16023659|NCT02712723|Drug|Letrozole|Nonsteroidal aromatase inhibitor
16023660|NCT02712723|Drug|Ribociclib|Oral cyclin-dependent kinase (CDK) inhibitor
16023661|NCT02712723|Drug|Placebo|Placebo for ribociclib
16023662|NCT02712710|Device|functional knee brace|The functional knee brace for OA can decrease abnormal varus torque by external force.
16023663|NCT02712697|Drug|WM (Shentong Granules)|Shentong Granules with Prednisone
16023664|NCT02712697|Drug|Hormone (prednisone)|Oral prednisone
16023665|NCT02712684|Procedure|multiparametric MRI. Multi-parametric ultrasound|The investigators aim to test the hypothesis that multiparametric ultrasound is able to detect clinically significant prostate cancer with an accuracy that is similar to multiparametric MRI. Multi-parametric ultrasound uses different types of ultrasound images to visualise different aspects of the tissue. In other words, the standard grey-scale images shows the gross anatomy, Power Doppler and Contrast enhanced Ultrasound image blood supply (cancers have more blood supply), and Real-Time Elastography images the density of tissue (cancers are more dense).
16023666|NCT02712671|Radiation|Chest radiograph|A chest radiograph involves the participant standing in front of a film and a low dose of radiation passes through the chest. This will be used to look for evidence of tuberculosis infection.
16023667|NCT02712671|Procedure|Blood interferon gamma release assay|Test of T-lymphocytes' response to exposure with tuberculosis antigens. This test is used for the diagnosis of latent tuberculosis infection and involves a blood sample in lithium heparin tube. It will be performed in an off site laboratory (Oxford Immunotec, Abingdon, Oxfordshire, United Kingdom).
16023668|NCT02712671|Procedure|Tuberculin skin testing (TST)|An intradermal test for latent tuberculosis infection that involves a small injection of purified protein derivative (PPD) from inactivated Mycobacterium tuberculosis. The reaction is interpreted at 48-72 hours by measuring the induration produced.
16023669|NCT02712671|Procedure|Sputum induction for mycobacterial microscopy and culture|Participants will breathe in a nebuliser salt solution (3.5% normal saline) for 15 minutes and asked to cough up a sputum sample. This is undertaken in a negative pressure tent. The sample will be tested for mycobacteria under the microscope and then cultured for 42 days in liquid culture bottles the microbiology laboratory.
16023670|NCT02712671|Other|Mycobacterium tuberculosis polymerase chain reaction testing|Sputum from sputum induction will be tested using the GeneXpert system using polymerase chain reaction to identify genes present in Mycobacterium tuberculosis. This test is performed in a microbiology laboratory and tests for the presence of Mycobacterium tuberculosis in sputum, plus genes associated with drug resistance.
16023671|NCT02712671|Procedure|Spirometry|Participants will be asked to blow into a spirometer to measure how much air they can expel in one second and in a whole breath. This will be repeated six times (three times before inhaling 3.5% saline solution and three times five minutes after breathing 3.5% saline solution). The results will be used to identify those whose airways are sensitive to the solution and to look for the presence of airways disease (asthma or chronic obstructive pulmonary disease).
16023672|NCT02712658|Drug|Terbutaline|K+ transport and Ca2+ release and uptake function are stimulated by administration of terbutaline
16023673|NCT02712658|Drug|Placebo|
16023674|NCT02712619|Drug|Metformin|
16023675|NCT02712593|Dietary Supplement|Niagen™ 100|
16023676|NCT02712593|Dietary Supplement|Niagen™ 300|
16023677|NCT02712593|Dietary Supplement|Niagen™ 1000|
16023678|NCT02712593|Other|Placebo|
16023679|NCT02712580|Device|First investigational device|The irradiation time is 30 minutes a day, the depth of penetration of the electrons in the skin stimulation is 1.5 uA. The irradiation is accompanied by white light.
16023680|NCT02712580|Device|Second investigational device|The irradiation time is 30 minutes a day, the depth of penetration of the electrons in the skin stimulation is 1.5 uA. The irradiation is accompanied by red light.
16023681|NCT02712580|Device|ES Wetling W200 Placebo with white light|The placebo-irradiation time is 30 minutes a day. The placebo irradiation is accompanied by white light.
16023682|NCT02712580|Device|ES Wetling W200 Placebo with red light|The placebo-irradiation time is 30 minutes a day. The placebo irradiation is accompanied by red light.
16023683|NCT02712567|Drug|Th-302|300 mg/m2 IV on Days 1 and 8 of a 21-day cycle.
16023684|NCT02712554|Drug|CL-108|7.5 mg/325 mg/12.5 mg tablet
16023689|NCT02712515|Procedure|Deep brain stimulation implantation surgery|Deep brain stimulation is a neuromodulatory therapy in which electrodes are implanted in deep brain structures. Electrical pulses are delivered through these electrodes to suppress pathological activity that are causing the symptoms of essential tremor or Parkinson's disease.
16023690|NCT02712515|Device|Ad-Tech Medical Instrumentation Corp. electrodes/subdural strips|Ad-Tech Medical Instrumentation Corp. electrodes are intraoperative monitoring subdural strips will be placed on the surface of the cortex (non-penetrating).
16023691|NCT02712515|Device|FHC Guideline 4000+ system and/or Medtronic RC+S|Brain signals will be recorded using the clinical Participants in this group with Parkinson's disease will be undergoing deep brain stimulation implantation surgery as part of the standard of care. In addition, the Ad-Tech Medical Instrumentation Corp. device will be used to test responses with wireless sensors placed on the participant's arms, which can record EMG activity. Brain signals will be recorded using the clinical FHC Guideline 4000+ system and/or Medtronic RC+S devices, which are capable of recording during stimulation.
16023692|NCT02712502|Drug|Levofloxacin|"Levofloxacin (Levolet) 750 mg (500 mg Levolet P + P Levolet 250 mg) 1 times a day. The course of treatment is 5 days.
~Decongestants: xylometazoline 2 doses in each nostril two times daily - the first 5 days, then if necessary."
16023693|NCT02712502|Drug|Amoxicillin-Potassium Clavulanate Combination|"Amoxicillin-Potassium Clavulanate Combination (875 mg of amoxicillin trihydrate, potassium clavulanate salt + 125 mg), 2 times a day. The course of treatment 10 days.
~• Decongestants: xylometazoline 2 doses in each nostril two times daily - the first 5 days, then if necessary."
16023694|NCT02712489|Other|No intervention|
16023695|NCT02712476|Drug|mannitol|This drug is in our routine use of neuroanesthesia, are given in peroperatifyl brain relaxation
16023696|NCT02712476|Drug|Furosemide|This drug is can be used alone or with mannitol for brain relaxation
16023697|NCT02712476|Drug|placebo|mannitol alone is compared with placebo
16023698|NCT02712437|Behavioral|PROSPECT|PROSPECT is an internet-based exercise and behavioral symptom management program developed for patients who experience long-term side effects from cancer treatment. The cancer-specific symptom management intervention is intended as a self-management adjunct to improve cancer- and treatment-related symptoms, including insomnia, through non-pharmacologic approaches.
16023699|NCT02712424|Biological|DAR-901|
16023700|NCT02712424|Biological|Sterile saline placebo|
16023701|NCT02712411|Drug|HCP1303|
16023702|NCT02712411|Drug|HGP1201|
16023703|NCT02712411|Drug|HIP1402|
16023704|NCT02712398|Device|Phasix™ ST|Phasix™ ST is a fully resorbable mesh with a hydrogel coating that is also resorbable.
16023705|NCT02712385|Other|'The Healthy Brain Rehabilitation Manual'|The Healthy Brain Rehabilitation Manual is a home-based rehabilitation manual developed for the post-TIA and minor stroke population caused by ischaemic events. The manual addresses all the secondary prevention factors required post-ischaemic TIA/minor stroke, e.g. smoking cessation, physical activity promotion.
16023706|NCT02712385|Device|Pedometer|Pedometer used to measure step counts as an objective measurement of level of physical activity.
16023707|NCT02712385|Procedure|Usual care|Usual care provided by healthcare system for patients who suffer a TIA or minor stroke will be recorded and form 'active comparator' control.
16023708|NCT02712385|Behavioral|Telephone follow-up|Telephone follow-up by either a General Practitioner (GP) or Stroke nurse.
16023709|NCT02712372|Drug|AZD4831|AZD4831 1-50 mg/g oral suspension
16023710|NCT02712372|Drug|AZD4831 placebo|AZD4831 placebo oral suspension
16023711|NCT02712359|Other|Blood sample collection|A blood sample (~5mL) will be collected from all subjects at each cross-sectional survey (Year 8 and Year 10).
16023712|NCT02712346|Drug|Ambrisentan|Ambrisentan 5 milligrams a day or a placebo (sugar pill) for twelve weeks
16023713|NCT02712346|Drug|Placebo|One inactive pill daily for twelve weeks
16023714|NCT02712333|Behavioral|Air Purifiers|The 17 dormitory rooms and their residents were randomized into two groups: the intervention and control group. The intervention group went through a 9-day intervention with an air purifier placed in the center of the room. All rooms in this group used the same qualified air purifiers (model KJEA200e, 3M), and all participants were required to stay in their dormitory rooms with the windows/doors closed throughout intervention period. All participants and research staffs were blinded to the group assignment.
16023715|NCT02712333|Behavioral|Sham Air Purifiers|The control group went through a 9-day intervention with a sham air purifier (with its filter gauze removed) placed in the center of the room. All rooms used the same air purifiers (model KJEA200e, 3M) as the intervention group, except the filter gauze was removed. During the study period all participants were required to stay in their dormitory rooms with the windows/doors closed. All participants and research staffs were blinded to the group assignment.
16023716|NCT02712320|Drug|LMIS 50 mg|Subcutaneous injection of 50 mg Leuprolide Mesylate
16023717|NCT02712307|Drug|Phenoxymethylpenicillin|
16023718|NCT02712294|Other|Neuromuscular Electrical Stimulation|
16023719|NCT02712281|Behavioral|Autism MEAL Plan|"The Autism MEAL plan includes education on feeding issues and behavior management, and specific strategies to expand dietary diversity. Each parent receives 1.5 hours of intervention per week for 10 weeks by a masters or doctoral level clinician. The first three sessions focus on understanding feeding problems and behavior management strategies in children with ASD.The next seven sessions include child-specific feeding interventions, based on parent-report and home data collection of child meal time behavior. To promote application of new skills, homework accompanies each lesson.
~The next seven sessions include child-specific feeding interventions, based on parent-report and home data collection of child meal time behavior. To promote application of new skills, homework accompanies each lesson."
16023720|NCT02712281|Behavioral|Parent Education|"The Parent Education study arm includes 10 sessions focusing on the following topics: understanding Autism Spectrum Disorder (ASD), clinical assessments for ASD, development in children with ASD, medical and genetic comorbidities in ASD, family and sibling issues, treatment alternatives, and education and treatment planning. The Parent Education arm does not include topics related to feeding problems or feeding specific interventions. Each parent receives 1.5 hours of intervention per week for 10 weeks by a masters or doctoral level clinician.
~Children randomized to Parent Education will be offered the Autism MEAL Plan after completing the 10-week randomized trial."
16023781|NCT02711865|Biological|IGF1R antibody MK0646|
16023782|NCT02711865|Other|Saline solution|
16023721|NCT02712268|Other|Checklist|Introduction of a 5-point checklist to be used by all physicians on the internal medicine wards to review and adapt the medications of the patient.
16023722|NCT02712255|Behavioral|Individual Planning|"CONTENT: The planning materials and forms have sections: (a) information on the importance of planning, including examples of how planning works and what it affects, (b) instructions of what should be included in a good plan (the when, where, and how components), (c) formulating action and coping plans.
~Action plans (referring to when, when, and how the individual will act) as well as coping plans (referring to how to overcome potential difficulties, risky situations or temptations to not engage in physical activity). Each participant will form their plans individually, without consulting the dyadic partner, but discussing the plans with the experimenter."
16023723|NCT02712255|Behavioral|Dyadic Planning|"CONTENT: The planning materials and forms have sections: (a) information on the importance of planning, including examples of how planning works and what it affects, (b) instructions of what should be included in a good plan (the when, where, and how components), (c) formulating action and coping plans.
~Action plans (referring to when, when, and how the individual will act) as well as coping plans (referring to how to overcome potential difficulties, risky situations or temptations to not engage in physical activity). Both partners in the dyad jointly form one plan. This jointly developed plan is discussed with the experimenter.
~The plan focuses on physical activity of only one person in the dyad: the patient."
16023724|NCT02712255|Behavioral|Collaborative Planning|"CONTENT: The planning materials and forms have sections: (a) information on the importance of planning, including examples of how planning works and what it affects, (b) instructions of what should be included in a good plan (the when, where, and how components), (c) formulating action and coping plans.
~Action plans (referring to when, when, and how the individual will act) as well as coping plans (referring to how to overcome potential difficulties, risky situations or temptations to not engage in physical activity). Both partners in the dyad jointly form one plan. This jointly developed plan is discussed with the experimenter.
~The plan focuses on physical activity of both persons within the dyad (the patient and the partner) and include some plans for joint physical activity."
16023725|NCT02712255|Behavioral|Education|CONTENT: The education materials address physical activity and healthy nutrition guidelines for age groups and chronic disease. Participants receive a set of educational materials about types of physical activity (PA), PA intensity, exercise calorie expenditure, strength and endurance training, stretching, and general nutrition guidelines in terms of meal composition, and nutrients, meal frequency. The materials exclude any planning statements. The education is delivered by the experimenter to a patient-partner dyad and discusses individual guidelines for both dyadic partners.
16023726|NCT02712242|Other|Platelet Rich Fibrin|Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after PRF placing on palatal wounds.
16023727|NCT02712242|Other|Butyl cyanoacrylate|Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after Butyl Cyanoacrylate application on palatal wounds.
16023728|NCT02712242|Other|Wet gauze|Immediate and delayed bleeding, pain, epithelialization, feeding habits and sensation scores were recorded after wet gauze pressure on palatal wounds.
16023729|NCT02712229|Behavioral|CONNECT|"Primary palliative care, care management intervention led by existing oncology nurses. Deployed through a series of nurse-led encounters before or after regularly scheduled oncology visits. Based on best practices in palliative oncology care, the first visit focuses on establishing rapport, addressing symptom needs and choosing a surrogate decision maker. Subsequent visits include additional focus on treatment preferences and future goals.
~Visits are guided by patient-reported outcomes. During all encounters, the nurse works with patients/caregivers to complete/update individualized Shared Care Plans. After all visits, the nurse discusses patients' symptoms, preferences and goals with their oncologists via a mandatory check-in session and a follow-up call with the patient and/or caregiver."
16023730|NCT02712216|Procedure|Laparoscopy|Determine best port sites to insert bariatric trocars
16023731|NCT02712203|Biological|MMR vaccine / MMRV vaccine|Subcutaneous injection, two doses
16023732|NCT02712190|Device|High-frequency non-invasive ventilation|Comparison of 2 different settings of HF-NIV
16023733|NCT02712177|Biological|4CMenb|
16023734|NCT02712177|Biological|diphtheria,tetanus,pertussis+polio+Hepatitis B+HiB|
16023735|NCT02712177|Biological|conjugated pneumococcal vaccine|
16023736|NCT02712177|Biological|MMRV|
16023737|NCT02712164|Device|Modified NPWT dressing|Use of negative pressure wound therapy on split-thickness skin graft (STSG) donor sites
16023738|NCT02712164|Device|Tegaderm|Standard of care for STSG donor sites.
16023739|NCT02712151|Procedure|Abdominal Wall Block|bilateral TAP and RS blocks.
16023740|NCT02712151|Procedure|Surgical infiltration|distributed between the 4 laparoscopic port sites.
16023741|NCT02712151|Drug|Sterile saline|Placebo injection
16023742|NCT02712151|Drug|Ropivacaine 0.2%|Ropivacaine 0.2% 1.0 ml/kg total in divided doses for bilateral TAP and RS blocks.
16023743|NCT02712151|Device|Ultrasound|For nerve localization
16023744|NCT02712151|Drug|Ropivacaine 0.5%|Ropivacaine 0.5% 0.4 ml/kg total in divided doses distributed between the 4 laparoscopic port sites
16023745|NCT02712125|Drug|isosorbide mononitrate|20 mg isosorbide mononitrate (IMN) tablet applied vaginally once daily until delivery .
16023746|NCT02712125|Drug|Placebo|placebo vaginal tablets once daily until delivery
16023748|NCT02712086|Other|protein supplementation|Protein supplementation : Protein intake of 30 grams of protein in addition to the usual inputs (to the recommended amounts of 60 to 120 g per day), upon the resumption of oral intake until the fifth week after sleeve gastrectomy.
16023749|NCT02712073|Other|Questionnaire|Self administered questionnaire to evaluate the preparation quality of colonoscopy
16023750|NCT02712060|Other|No intervention|
16023751|NCT02712047|Drug|Fluticasone furoate (FF) (100 mcg)|First blister strip contains FF blended with lactose, 100 mcg per blister
16023752|NCT02712047|Drug|Vilanterol (VI) (25 mcg)|Second blister strip contains vilanterol blended with lactose and magnesium stearate, 25 mcg per blister
16023753|NCT02712047|Drug|Placebo|Matching placebo will have two blister strips, identical in appearance to the inhaler containing active study medication; one containing lactose and the second strip containing lactose and magnesium stearate
16024072|NCT02710071|Drug|Nebivolol|Nebivolol 5mg then nebivolol 10 mg
16023754|NCT02712034|Behavioral|MAT + A-CHESS|"Subjects randomized to MAT + A-CHESS will receive MAT plus the A-CHESS recovery support system which provides:
~Self-directed, interactive modules that teach basic recovery support, harm-reduction, and psychosocial functioning skills.
~The latest information about addiction and recovery support, monitoring prompts, and peer and family support.
~Advice on where to go for help and on how to make the best use of health and human services; and
~A way to talk with experts in the area of addiction and other study participants by sending anonymous messages in the A-CHESS discussion groups.
~A way to keep your health care team up to date through reports based on information entered into A-CHESS (i.e. alcohol and drug use, depression, MAT side effects)."
16023755|NCT02712034|Other|MAT|"Patients will receive treatment consisting of a recovery plan, appropriate pharmacology, routine urine screens, and regularly scheduled behavioral interventions, such as monthly group counseling sessions or sessions with a recovery coach. Appropriate pharmacology may include methadone; naltrexone; buprenorphine; and in the case of overdose, naloxone; and other medications and combinations of medications as part of the patient's standard clinical care."
16023756|NCT02712021|Other|Lycra suit and physiotherapy treatment|Garments will be fitted by an occupational therapy with the treating therapist and child neurologist present. The garments will be constructed of Lycra with the possibility of adding reinforcing panels or derotation bands. All the children will be involved in regular physiotherapy treatment (2-3/week).
16023757|NCT02712021|Other|physiotherapy treatment|All the children will be involved in regular physiotherapy treatment (2-3/week).
16023758|NCT02712008|Drug|REGN910-3|Co-formulation for intravitreal (IVT) injection consisting of REGN910 (nesvacumab) and REGN3 (aflibercept)
16023759|NCT02712008|Drug|Intravitreal Aflibercept Injection (IAI)|
16023760|NCT02711995|Drug|RenuGel|Injection augmentation is the injection of a filler material (Brand: RenuGel; generic: Carboxymethylcellulose) into the vocal cords through the skin of the neck, guided by the view from a flexible laryngoscope inserted through the nostril. The flexible laryngoscopy is identical to the procedure that the doctor has used to examine your vocal cords in the past. It is the routine diagnostic evaluation technique of voice disorders.
16023761|NCT02711995|Drug|Botulinum Toxin|Botulinum toxin treatment is the injection of botulinum toxin into the muscles of the vocal cords through the skin of the neck. This is identical to the injections you may have received in the past for your disorder.
16023762|NCT02711982|Procedure|Optic canal and optic nerve sheath decompression|within 5 days from trauma
16023763|NCT02711982|Drug|methylprednisolone|within 5 days from trauma
16023764|NCT02711969|Drug|Apatinib mesylate|1,000mg Apatinib mesylate p.o. qd
16023765|NCT02711956|Drug|ZEN003694|
16023766|NCT02711956|Drug|Enzalutamide|
16023767|NCT02711943|Drug|Levofloxacin 500|Oral levofloxacin (Levolet®) at a dose of 500 mg once a day for 28 days
16023768|NCT02711917|Drug|MAC 0.5|0.5 MAC Sevoflurane
16023769|NCT02711917|Drug|MAC 0.75|0.75 MAC Sevoflurane
16023770|NCT02711917|Drug|MAC 1.0|1.0 MAC Sevoflurane
16023771|NCT02711917|Drug|Propofol|Propofol consumption
16023772|NCT02711917|Drug|Etomidate|Etomidate consumption
16023773|NCT02711917|Drug|Rocuronium|Consumption of Rocuronium
16023774|NCT02711904|Drug|Extubation U|"Dose of remifentanil according to the randomization; the infusions that were used to reach the PC target were:
~20 years old - 6.0 mcg/Kg/h
~30 years old - 5.7 mcg/Kg/h
~40 years old - 5.3 mcg/kg/h
~50 years old - 5.0 mcg/kg/h
~60 years old - 4.6 mcg/kg/h
~70 years old - 4.3 mcg/kg/h
~80 years old - 4.0 mcg kg/h."
16023775|NCT02711904|Drug|Extubation T|"Dose of infusion of remifentanil to reach a PC 3 - 4 ng/ml, in the following manner:
~The assistant placed the infusion balloon in such a way that it could not be seen by the treating anesthesiologist, he proceeded to open the corresponding wrapping according to the consecutive which corresponds to the patient.
~The remifentanil dose was adjusted according to the randomization:
~20 years old - 9.0 mcg/Kg/h
~30 years old - 8.5 mcg/Kg/h
~40 years old - 8.0 mcg/kg/h
~50 years old - 7.5 mcg/kg/h
~60 years old - 7.0 mcg/kg/h
~70 years old - 6.5 mcg/kg/h
~80 years old - 6.0 mcg kg/h."
16023776|NCT02711891|Drug|Loperamide|Following lance one, 0.2 grams of loperamide 5% gel was applied from a sterile syringe to the participants previous lance site within an 8 mm diameter circular plastic mold. The loperamide gel was rubbed lightly on the skin surface for one minute using a gloved finger swirled into the mold site. The mold was removed and the site was covered with a transparent occlusive dressing for 30 minutes. At 30 minutes the gel was removed with gauze, the skin cleaned with an alcohol wipe and the second lance was done within the same location as the first. The loperamide gel was also swabbed to the forearm within the 8 mm mold and left in place for 30 minutes.
16023777|NCT02711891|Drug|Drug, placebo gel|Following lance one, 0.2 grams of gel alone was applied to the participants previous lance site within an 8mm diameter circular plastic mold. The gel was rubbed lightly on the skin surface for one minute using a gloved finger swirled into the mold site. The mold was removed and the site was covered with a transparent occlusive dressing left in place for 30 minutes. At 30 minutes the gel was removed with gauze, the skin cleaned with an alcohol wipe and the second lance was done within the same location as the first. The placebo gel was also swabbed to the forearm within the 8 mm mold and left in place for 30 minutes.
16023778|NCT02711878|Behavioral|Let's Move Program|Participants will be asked to walk five times per week for twelve weeks for a minimum of 30 minutes while wearing a heart rate monitor and a pedometer. Participants will also receive weekly telephone calls from a member of the research team to monitor walking progress and to change walking duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen.
16023779|NCT02711878|Behavioral|Let's Flex Program|Participants will be asked to stretch five times per week for twelve weeks for a minimum of 30 minutes. Participants will also receive weekly telephone calls from a member of the research team to monitor progress and to change duration or intensity level based on their progress.After the twelve week period, participants will enter a maintenance exercise phase for weeks 13-17 in which they will be asked to maintain their exercise regimen.
16023780|NCT02711878|Behavioral|Group Motivational Interviewing|Participants will attend four separate group intervention sessions for 2.5 hours for four consecutive weeks at the beginning of the program. Groups will consist of 6-8 members and will focus on the rationale for aerobic exercise, barriers to exercise, finding time for exercise, how to set short and long term exercise goals, and use of self-monitoring to improve exercise engagement.
16023783|NCT02711852|Drug|Duvelisib|Subjects will begin taking the same dose from their previous duvelisib study. All doses are taken by mouth twice daily (BID). Two dose reductions are allowed per subject, but doses may not be less than 10 mg. Subjects will take duvelisib until disease progression or unacceptable toxicity.
16023784|NCT02711839|Dietary Supplement|Commercial diabetic formula|The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation
16023785|NCT02711839|Dietary Supplement|White sweet potato formula|The formula were supplied 1500~1800 kcal daily depend on the patient's individual situation
16023786|NCT02711826|Biological|Polyclonal Regulatory T Cells|Participants randomized to polyTregs group will receive a single infusion of 550 ± 450 x 10^6 polyTregs.
16023787|NCT02711826|Drug|Everolimus|
16023788|NCT02711826|Drug|Tacrolimus|
16023789|NCT02711826|Drug|Mycophenolate mofetil|All enrolled participants will be on MMF (or MPA below) at the time of study entry at a minimum dose of 1000mg per day.
16023790|NCT02711826|Drug|Mycophenolic acid|All enrolled participants will be on MPA (or MMF above) at the time of study entry at a minimum dose of 720mg per day.
16023791|NCT02711826|Drug|Acetaminophen|650 mg acetaminophen, administered 30-60 minutes prior to infusion as pre-medication.
16023792|NCT02711826|Drug|Diphenhydramine|25-50 mg diphenhydramine intravenously or by mouth, administered 30-60 minutes prior to infusion as pre-medication.
16023793|NCT02711826|Procedure|Biopsy, Kidney|
16023794|NCT02711826|Procedure|Blood Draw|
16023795|NCT02711826|Procedure|Leukapheresis|
16023796|NCT02711826|Procedure|IS regimen conversion|Conversion from Tacrolimus, a calcineurin inhibitors (CNI), to Everolimus, an mTOR inhibitor.
16023797|NCT02711813|Drug|TAB08|biologic
16023798|NCT02711813|Other|Placebo|
16023799|NCT02711800|Drug|Lactobacillus rhamnosus|The investigators will use Culturelle®, a probiotic composed of the micro-organisms Lactobacillus GG. This formulation has been used for the treatment of gastrointestinal inflammation in numerous clinical trials. Dosing will follow the manufacturer's recommendation for children (1 capsule/packet per day), and will be monitored by the study Co-PI, Dr. Seed. Weekly side effects and clinical changes will be monitored by both study therapist and caregiver using the Children's Global Assessment Scale and the Clinical Global Impression Scale (Severity, Improvement, and Efficacy). The treatment duration is 30 days.
16023800|NCT02711787|Device|Experimental group|Robotic assisted passive mobilization (Gloreha, Idrogenet, Italy) and traditional rehabilitation.
16023801|NCT02711787|Device|Control group|Physiotherapy and occupational therapy.
16023802|NCT02711787|Device|traditional rehabilitation|Assisted stretching, shoulder and arm exercises, and functional reaching tasks
16023803|NCT02711774|Device|ultrasonography|ONSD will be measured by a 6-13 MHz linear probe of the ultrasound machine.
16023804|NCT02711761|Device|central venous catheterization|"15 cm: The depth of guide wire prior to tissue dilation during central venous catheterization will be 15 cm.
~17.5 cm: The depth of guide wire prior to tissue dilation during central venous catheterization will be 17.5 cm.
~20 cm: The depth of guide wire prior to tissue dilation during central venous catheterization will be 20 cm."
16023805|NCT02711748|Device|electrostimulation|Electrostimulation using manual defibrillator
16023806|NCT02711748|Device|cardiopulmonary resuscitation|CPR according to guidelines of European Resuscitation Council. Cardiopulmonary resuscitation using manual defibrillator
16023807|NCT02711735|Biological|RUTI® Therapeutic vaccine|Participants randomised to this arm will receive one single dose of RUTI® vaccine in the right/left deltoid muscle.
16023808|NCT02711735|Biological|Matching RUTI® Placebo|Participants randomised to this arm will receive aone single dose of matching RUTI® placebo in the right / left deltoid
16023809|NCT02711722|Device|Neurally adjusted ventilatory assist|"Ventilation supported by NAVA
~Blood gas analysis
~Respiratory Parameters At the end of the study step Neuro-Ventilatory Efficiency and Neuro-Mechanical Efficiency are measured."
16023810|NCT02711722|Device|PScli1|Pressure support set by clinicians prior to inclusion
16023811|NCT02711722|Device|PScli2|Pressure support at the same level as prior to the study
16023812|NCT02711709|Other|Frailty Measurements|"A frailty index will be determined as a combination of factors.
~An older adult is considered physically vulnerable when they experience:
~muscle weakness
~fatigue
~low physical activity, and unintentional loss in body weight, which has been agreed upon by a consensus of experts.
~This will be collected at baseline, 3, 6 and 12 months."
16023813|NCT02711709|Other|Modified Minnesota Leisure Time Activities|A questionnaire used to assess physical activity will be administered at baseline, 3, 6 and 12 months.
16023814|NCT02711709|Other|Computed tomography morphometrics|A CT scan will occur as standard of care while the patient is hospitalized. Two additional CT scans will occur at 3 and 12 months to assess for sarcopenia.
16023815|NCT02711709|Other|Mobility Monitors|Mobility monitors will be placed on the patients during the duration of their hospital stay. They will then where them at 3, 6 and 12 months for up to 10 days.
16023816|NCT02711696|Behavioral|GCED, Gluten Contamination Elimination Diet|"A Gluten Free diet based exclusively on naturally gluten-free products and foods, with the elimination from the diet of all commercially available processed food and products labeled gluten free  (Gluten Contamination Elimination Diet, GCED)."
16023817|NCT02711683|Drug|DL-3-n-butylphthalide|the patients with mild to moderate AD have already been prescribed the drugs,we just observed passively.
16023818|NCT02711683|Drug|Donepezil|the patients with mild to moderate AD have already been prescribed the drugs,we just observed passively.
16023819|NCT02711670|Drug|chlorthalidone|
16023820|NCT02711670|Drug|Hydrochlorothiazide|
16023821|NCT02711657|Other|Fibrocyte measurement and lung function test.|
16023822|NCT02711644|Behavioral|Supportive Lifestyle Counselling|Each participant will meet with the intervention Registered Dietitian twice in pregnancy and have two follow-up phone calls. Participants in this group will have on-going, supportive discussions with the intervention Registered Dietitian about healthy lifestyles in pregnancy. Discussion topics with the intervention Registered Dietitian at each visit will be participant-centered, allowing the participant to guide the conversation. These conversations will be reinforced at every future contact made throughout pregnancy.
16023858|NCT02711332|Other|capillary blood sampling|Each subject will have four capillary blood collections on different fingers. A reference venous blood collection will be conducted.
16113846|NCT02059434|Drug|Tiotropium 18 μg|
16023823|NCT02711644|Behavioral|Standard Lifestyle Counselling|Each participant will meet in person with their respective Registered Dietitian twice in pregnancy and have two follow-up phone calls. At these visits, each participant will complete questionnaires and have anthropometric assessments (height/weight). From home, each participant will also complete online questionnaires at week 26, and week 34. Postpartum,each participant will complete an online questionnaire. Optional postpartum participation includes a focus group in the postpartum period and the option to meet with a Registered Dietitian postpartum.
16023824|NCT02711631|Behavioral|MedBIKE|MedBIKE is an exercise cardiac rehabilitation system that allows participants to perform clinical cardiac rehabilitation at home or at a local center, instead of having to travel to the hospital. It provides a high level of physiological monitoring to allow patient safety to be continually monitored while exercising.
16023825|NCT02711618|Device|UltraShape Contour I V3|Tissue selectivity is achieved by a proprietary knowledge of parameters ensuring specific destruction of the fat cells only within the target area. All other types of tissue, such as blood vessels, muscles and peripheral nerves remain intact. There are no thermal effects. Fat cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time
16023826|NCT02711605|Device|UltraShape focused ultrasound device|3 biweekly focused ultrasound treatments to the male chest with UltraShape.
16023827|NCT02711592|Genetic|Genetic Panel for Analgesics|All patients will receive genetic test panel to determine individualized optimal pain management following Total Knee Arthroplasty.
16023828|NCT02711579|Drug|Celecoxib|
16023829|NCT02711579|Drug|Placebo|
16023830|NCT02711566|Device|Physioassistant: Haptic training|Subjects in the Haptic training arm had to perform fast-and-accurate reaching movements in different directions. reaching was mediated by a virtual 'tool', consisting of a virtual point mass (m=5 kg) connected to the subjects' hand through a linear spring (stiffness range: Km=200-500 N/m). An additional spring (stiffness range: Kr = 20-70 N/m) was connected between hand a starting point to resist movements. Subjects were instructed to move the virtual point mass as fast as possible through suitable hand motions, so that the mass ends up and stops on the 'target' area.
16023831|NCT02711566|Device|Physioassistant: Sensorimotor training|Subjects in the Sensorimotor training arm had to perform fast-and-accurate reaching movements in different directions. The manipulandum was only used to record hand movements, but throughout the movement it generated no forces.
16023832|NCT02711553|Drug|Ramucirumab|Administered IV
16023833|NCT02711553|Drug|Merestinib|Administered orally
16023834|NCT02711553|Drug|Cisplatin|Administered IV
16023835|NCT02711553|Drug|Gemcitabine|Administered IV
16023836|NCT02711553|Drug|Placebo Oral|Administered orally
16023837|NCT02711553|Drug|Placebo IV|Administered IV
16023838|NCT02711540|Procedure|Balloon Aortic Valvuloplasty|Some patients receive BAV prior to TAVI implantation to facilitate better deployment of the TAVI valve
16023839|NCT02711527|Other|Acupunture group A|"Subjects in Group A will receive 14 needles based on the TCM theory Soothing liver-qi stagnation, all needles will be retained for 30 minutes. Acupoint combination: Taichong太衝 (LR 3), Ligou蠡沟 (LR 5), Zhongdu 中都(LR6), Xiguan膝關 (LR 7), Ququan曲泉 (LR 8), Zhangmen章門(LR13), Qimen期門 (LR14)."
16023840|NCT02711527|Other|Acupunture group B|"Subjects in Group B will receive 14 needles based on the TCM theory Soothing liver-qi stagnation and Tonifying the heart and the spleenand Invigorating the Yang Qi, all needles will be retained for 30 minutes. Acupoint combination: Taichong太衝 (LR 3), , Sanyinjiao 三陰交 (SP 6), Xuanzhong懸鐘 (GB 39), Shenmen 神門 (HT 7), Zusanli 足三里(ST 36), Baihui 百會(DU 20), Shenting神庭(DU24), Qihai 氣海(RN6), Guanyuan 關元(RN4). Teding Diancibo Pu (abbreviation: TDP) 特定電磁波譜 will be applied to Group B immediately after the needle insertion."
16023841|NCT02711501|Procedure|Laser-assisted surgery.|laser-assisted surgery
16023842|NCT02711501|Procedure|conventional surgery by blade|conventional surgery
16023843|NCT02711488|Behavioral|Intervention group|"The proposed intervention will focus on encouraging students to change their eating habits and food consumption over 9 months (from March to November). Monthly 1-h sessions in the classroom will be given by the class teacher, and includes playing games, staging theater sketches, watching movies and puppet shows, and writing and drawing contests. The activities were designed to discourage students from consuming sugar-sweetened beverages as well as getting them to replace snacks, particularly processed foods (especially cookies) with fresh fruit or healthy homemade food. To reinforce the messages of the in-class nutritional sessions, a set of messages will be sent to the families in the form of illustrated booklets and recipes.
~The secondary prevention strategy at households will be developed for those with excessive weight. The family will receive additional motivation to change these behaviors, using the community health agents as the encourager."
16023844|NCT02711462|Drug|PF-06687234|PF-06687234 will be administered via the SC or the IV route and in either single dose or multiple doses
16023845|NCT02711462|Drug|Placebo|In Cohorts 1 and 2, up to 1 subject will receive placebo. In all other Cohorts (Cohorts 3 to 11), up to 2 subjects will receive placebo.
16023846|NCT02711449|Drug|Methylprednisolone|125 mg methylprednisolone as an intravenously bolus injection approximately 30 minutes prior to skin incision.
16023847|NCT02711449|Drug|0.9% Saline|0,9% Saline as an intravenously bolus injection approximately 30 minutes prior to skin incision.
16023848|NCT02711436|Device|Computed Tomography Scan|
16023849|NCT02711436|Device|Fast Magnetic Resonance Imaging|
16023850|NCT02711423|Drug|Gantenerumab|Gantenerumab will be supplied as a high-concentration liquid formulation for SC injection into the abdomen. The single dose will be administered on Day 1.
16023851|NCT02711423|Drug|Placebo|Placebo will be supplied as a matching liquid formulation for SC injection into the abdomen. The single dose will be administered on Day 1.
16023852|NCT02711410|Drug|Clopidogrel|
16023853|NCT02711397|Other|Observational study|Comparison excretion levels of gluten immunogenic peptides
16023854|NCT02711371|Other|fMRI|
16023855|NCT02711358|Drug|indomethacin suppositories|The patients will be instructed to self-administer a single rectal dose of 50 mg indomethacin 30 min before the scheduled time of the procedure
16023856|NCT02711358|Drug|placebo|The patient swill be instructed to self-administer a single rectal dose of placebo 30 min before the scheduled time of the procedure
16023857|NCT02711345|Drug|LTT462|ERK Inhibitor
16026148|NCT02695433|Dietary Supplement|Control|Control Diet Plan
16023859|NCT02711332|Other|venous blood sampling|Each subject will have four capillary blood collections on different fingers. A reference venous blood collection will be conducted.
16023860|NCT02711319|Device|rTMS|For real (active) rTMS, we applied 2 seconds duration bursts of 20 Hz (40 pulses/burst) with intertrain intervals of 28 seconds, for a total of 1800 pulses over 20 minutes
16023861|NCT02711319|Device|sham rTMS|"Sham Comparator: sham rTMS (SHAM GROUP)
~For sham rTMS, the double cone coil was again held over the vertex, but it was disconnected from the main stimulator unit. Instead, a second coil (8-shaped) was connected to the MagStim stimulator, and discharged under the patient's pillow (2)."
16023862|NCT02711306|Dietary Supplement|Glucomannan noodle|The participants received two servings (400 g) of GMN every day to replace their daily carbohydrate intake for 4 weeks.
16023863|NCT02711306|Dietary Supplement|Placebo noodle|In the placebo noodle diet, the participants received the same amount of noodles without glucomannan for 4 weeks.
16023864|NCT02711293|Other|ART home delivery|Community health workers visit participants who are clinically stable on antiretroviral therapy (ART) at home (maintaining patients' prior clinic visit frequency) to deliver ART. Clinically stable on ART was defined as 1) taking ART for at least six months, 2) having had a CD4-cell count >350 cells/μL or a suppressed viral load at six or more months after ART initiation, and 3) the patient's most current CD4-cell count must have been >350 cells/μL or the most current viral load must have shown viral suppression, with the last measurement not taken more than 12 months ago.
16023865|NCT02711293|Other|Enhanced nutrition counseling|Community health workers visit participants at home to provide standard counseling (focusing on family planning, prevention of HIV transmission, and ART adherence) plus enhanced nutrition counseling (covering food production and dietary advice). In addition, participants who state that they have access to a plot of land or garden to grow vegetables receive a pack of seeds (amaranth, cowpea, or pumpkin) at enrolment.
16023866|NCT02711280|Drug|Sevoflurane|
16023867|NCT02711280|Drug|Propofol|
16023868|NCT02711267|Drug|5% Zovirax® cream|(manufactured by GlaxoSmithKline Pharma in Canada, distributed in the USA by Valeant Pharmaceuticals North America LCC, Bridgewater,NJ 08807)
16023869|NCT02711267|Drug|5% Aciclostad cream|(STADA Arzneimittel GmbH, Vienna, Austria)
16023870|NCT02711267|Drug|5% Aciclovir cream 1A Pharma|(1A Pharma GmbH, Vienna, Austria)
16023871|NCT02711267|Drug|5% Zovirax Cold Sore Cream|(GlaxoSmithKline Consumer Health Care, Brendfort, UK; Marketing authorization holder: Beeham Group PLC, Brendfort, UK)
16023872|NCT02711267|Drug|5% Zovirax® cream (Austria)|(GlaxoSmithKline Pharma GmbH, Vienna, Austria)
16023873|NCT02711267|Procedure|OFM|Sampling method for interstitial fluid
16023874|NCT02711267|Device|OFM Probe|Sampling probe used during OFM
16023875|NCT02711267|Device|OFM Pump|Pump used to operate OFM probes
16023876|NCT02711241|Drug|Dipyrone|1 gram by slow IV infusion
16023877|NCT02711241|Drug|Papaverine|80 mg by slow intravenous infusion
16023878|NCT02711228|Biological|Subcutaneous Immune Globulin (Human) (Hizentra)|Hizentra, Subcutaneous Immune Globulin (Human) (SCIg), is a ready to use, polyvalent human normal Immunoglobulin G (IgG) for subcutaneous administration. Hizentra is a 20% IgG protein solution, is prepared from large pools of human plasma, and is stabilized by L-Proline.
16023879|NCT02711215|Diagnostic Test|PET/MR [11C]DASB|2 PET/MR scans will be performed (placebo/citalopram - double-blind randomized cross-over)
16023880|NCT02711215|Drug|Citalopram|8mg citalopram or placebo (saline) will be applied during PET/MR measurements in a double-blind randomized cross-over design
16023881|NCT02711215|Drug|Escitalopram (Mirtazapine/Duloxetine/Venlafaxine)|After completion of imaging procedures, patients will receive treatment with escitalopram 10-20mg. In case of non-response, after 6 weeks, treatment will be switched to either Mirtazapine, Duloxetine or Venlafaxine
16023882|NCT02711215|Drug|Placebo|8mg citalopram or placebo (saline) will be applied during PET/MR measurements in a double-blind randomized cross-over design
16023883|NCT02711202|Drug|MabCampath,|Primary deceased donor kidney transplant recipients received 2x20 mg Alemtuzumab (day 0/day 1) followed by 5 mg/kg Infliximab (day 2). For 14 days all patients received only tacrolimus, then they were randomized to either receive tacrolimus (TAC, n=13) or sirolimus (SIR, n=7) monotherapy, respectively.
16023884|NCT02711202|Drug|Remicade|Primary deceased donor kidney transplant recipients received 2x20 mg Alemtuzumab (day 0/day 1) followed by 5 mg/kg Infliximab (day2). For 14 days all patients received only tacrolimus, then they were randomized to either receive tacrolimus (TAC, n=13) or sirolimus (SIR, n=7) monotherapy, respectively.
16023885|NCT02711202|Drug|Sirolimus|Primary deceased donor kidney transplant recipients received 2x20 mg Alemtuzumab (day 0/day 1) followed by 5 mg/kg Infliximab (day 2). For 14 days all patients received only tacrolimus, then they were randomized to either receive tacrolimus (TAC, n=13) or sirolimus (SIR, n=7) monotherapy, respectively.
16023886|NCT02711202|Drug|Tacrolimus|Primary deceased donor kidney transplant recipients received 2x20 mg Alemtuzumab (day 0/day 1) followed by 5 mg/kg Infliximab (day 2). For 14 days all patients received only tacrolimus, then they were randomized to either receive tacrolimus (TAC, n=13) or sirolimus (SIR, n=7) monotherapy, respectively.
16023887|NCT02711189|Drug|Oxytocin|Oxytocin nasal spray given in dose 80
16023888|NCT02711189|Other|Placebo|
16023889|NCT02711176|Drug|Nexium|Patients in experimental group will receive the 14 day single dose of Nexium 40 mg daily
16023890|NCT02711176|Drug|Tinafas|Patients in experimental group will receive the 14 day single dose regimen of Tinafas 1 g daily
16023891|NCT02711176|Drug|Tavanex|Patients in experimental group will receive the 14 day single dose of Tavanex 500 mg daily
16023892|NCT02711176|Drug|Lanzol|Patients in active comparator group will receive the 14 day lansoprazole (Lanzol) 30 mg twice daily
16023893|NCT02711176|Drug|Klacid|Patients in active comparator group will receive the 14 day clarithromycin (Klacid) 500 mg twice daily twice daily
16023894|NCT02711176|Drug|Iramox|Patients in active comparator group will receive the 14 day amoxicillin (Iramox) 1 g twice daily
16023895|NCT02711163|Dietary Supplement|Extensively Hydrolyzed formula|
16023896|NCT02711163|Dietary Supplement|Amino acid formula|
16023897|NCT02711150|Device|PLL Length Measured through US|The PLL will be measured for each allocated position: EPD or Flexed Position
16023959|NCT02710734|Drug|Mitomycin C|Intravenous on day 1 with radiation treatment
16026149|NCT02695420|Drug|25 mg Omecamtiv Mecarbil|oral tablet
16023898|NCT02711137|Drug|INCB057643|Initial cohort dose of INCB057643 at the protocol-specified starting dose (Part 1), with subsequent dose escalations based on protocol-specific criteria. The recommended treatment group-specific dose(s) will be taken forward into expansion cohorts (Part 2).
16023899|NCT02711137|Drug|INCB057643|Initial cohort dose of INCB057643 at the protocol-specified starting dose (Part 3), with subsequent dose escalations based on protocol-specific criteria. The recommended treatment group-specific dose(s) will be taken forward into expansion cohorts (Part 4).
16023900|NCT02711137|Drug|Gemcitabine|Standard of Care (SOC) agents
16023901|NCT02711137|Drug|Paclitaxel|Standard of Care (SOC) agents
16023902|NCT02711137|Drug|Rucaparib|Standard of Care (SOC) agents
16023903|NCT02711137|Drug|Abiraterone|Standard of Care (SOC) agents
16023904|NCT02711137|Drug|Ruxolitinib|Standard of Care (SOC) agents
16023905|NCT02711137|Drug|Azacitidine|Standard of Care (SOC) agents
16023906|NCT02711111|Device|Face mask|to apply for on the upper jaw (12 - 14 hrs / day) via extra-oral elastics to the face mask
16023907|NCT02711111|Device|orthodontic bone anchor|to apply force on the upper jaw (24 / 7) via intra-oral elastics on the bone-anchor
16023908|NCT02711098|Biological|"Inflammatory biomarkers dosage Hypothermia Arm"|There is 6 dosage of inflammatory biomarker per patient included: H0, H12, H24, H36, H48 and H72 during targeted temperature management between 33°C and 37°C.
16023909|NCT02711098|Biological|"Inflammatory biomarkers dosage Normothermia Arm"|There is 6 dosage of inflammatory biomarker per patient included: H0, H12, H24, H36, H48 and H72 during targeted temperature management at 37°C.
16023910|NCT02711085|Other|No intervention|No intervention - observational study
16023911|NCT02711072|Drug|control group|spinal anesthesia with 10 mg hyperbaric Bupivacaïne 0,5% + 2,5 µ Sufentanyl + 100 µ of intrathecal Morphine+ infiltration catheter with saline 5 ml/h
16023912|NCT02711072|Drug|infiltration group|spinal anesthesia with 10 mg hyperbaric Bupivacaïne 0,5% + 2,5 µ Sufentanyl + 1ml of saline + infiltration catheter with 5 ml/h of Bupivacaïne 0,125%.
16023913|NCT02711059|Procedure|parathyroidectomy|surgical treatment of hyperparathyroidism
16023914|NCT02711046|Procedure|single stage nasolabial flap|The versatility of this flap has been attributed to the fact that there is often abundant non-hair-bearing skin in this well-vascularized region. The facial and infraorbital arteries are frequently cited in anatomic descriptions of the nasolabial flap. The venous drainage is believed to be via the angular and facial veins.
16023915|NCT02711033|Procedure|Laparoscopic-assisted total gastrectomy|When patients with advanced proximal gastric cancer are randomized in the laparoscopic-assisted total gastrectomy (LATG) group, they will received LATG with spleen-preserving splenic hilum lymph nodes dissection.
16023916|NCT02711033|Procedure|Open total gastrectomy|When patients with advanced proximal gastric cancer are randomized in the open total gastrectomy (OTG) group, they will received OTG with spleen-preserving splenic hilum lymph nodes dissection.
16023917|NCT02711020|Behavioral|Cognitive Behavioral Therapy|Patients assigned to this arm will receive a maximum of 18 1-hour sessions of Cognitive Behavioral Therapy following the intervention techniques included in various group therapy manuals for patients with fibromyalgia, plus up to three 1-hour boost sessions between 3 and 5 months after the end of therapy. Techniques are adapted to individual format in the following modules: (1) Psychoeducation, (2) Relaxation, (3) Behavioral Activation, (4) Cognitive Restructuring, (5) Problem solving, (6) Assertiveness Training, and (7) Relapse Prevention.
16023918|NCT02711020|Behavioral|Personal Construct Therapy|"Patients will receive a maximum of 18 1-hour sessions of Personal Constructs Therapy plus up to three 1-hour boost sessions between 3 and 5 months after the end of therapy. The intervention will follow a protocol designed specifically for this project based on the clinical experience of a previous pilot study. It will consist of 4 stages: (1) Analysis of patient's request, goals setting, identification of the main dilemmas, and other personal meanings relevant for self and others' construction; (2) feedback on the assessment results and problem reframing in terms of a dilemma and/or other personal meanings; (3) work on the dilemmas and/or other aspects of the self and others' construction; and (4) end of the therapeutic process outlining personal projects and future perspectives."
16023919|NCT02711007|Drug|apatinib|Apatinib is a small-molecule VEGFR tyrosine kinase inhibitor, similar to vatalanib (PTK787), but with a binding affinity 10 times that of vatalanib or sorafenib.
16023920|NCT02710994|Drug|CDFR0209|Immediate release omeprazole 40 mg and sodium bicarbonate 1,100 mg
16023921|NCT02710994|Drug|Losec|Losec 40 mg
16023922|NCT02710981|Drug|clomiphene citrate|Clomiphene citrate only arm: Patients received Clomiphene citrate induction ( (in a dose of 100 mg/ day in two divided doses starting from day 3 of the cycle for 5 days) for the 6th cycle. A gel base, without medicament (vehicle only), was applied vaginally in a dose of 5 gm twice per day, from cycle day 8 to the day of HCG injection. Sonographic assessment of endometrial thickness together with Uterine artery Doppler evaluation were done in the late proliferative phase ( Day of HCG injection).
16023923|NCT02710981|Drug|Sildenafil vaginal gel|In addition to clomiphene citrate treatment as the previous group, women in the second arm were prescribed sildenafil vaginal gel in a dose of 5 g gel applied vaginally twice daily from cycle day 8 to the day of HCG injection. The sildenafil vaginal gel consists of sildenafil acetate as a medicament loaded on an in situ gelling system based on two polymers: Pluronic p-127, and Hydroxy Ethyl Cellulose.The gel was prepared in collaboration with the department of pharmaceutics, faculty of Pharmacy, Assiut University. Sixty grams of gel were prepared in tubes and every patient was given 10 applicators like that used for administration of vaginal antimycotic creams to use them for applying the gel.
16023924|NCT02710968|Device|11540KE and Balt Goldbal 2 balloon|Fetoscopic tracheal occlusion will be performed using above devices and reversed after 4-5 weeks.
16023925|NCT02710955|Dietary Supplement|Thickened infant formula|
16023926|NCT02710942|Behavioral|SPHERE|
16023927|NCT02710942|Behavioral|PRISM|
16023928|NCT02710916|Device|SD-OCT Spectralis|All patients will undergo a complete ophthalmological examination with SD-OCT complete evaluation
16023960|NCT02710721|Other|Fasting|Patients realize a 60h-modified fasting (36h before and 24h after chemotherapy) with a dietary energy supply 350-400kcal per day with fruit and vegetable juices or, if not feasible, an established fasting-mimicking diet of 600-800 kcal according to Longo et al. Between chemotherapy a Mediterranean diet with nutrition training individually and in small groups by trained nutritionists at the Study Centre will be practiced.
16023929|NCT02710903|Procedure|Stent-induced biofilm overgrowth|Customized stents will be fabricated for each subject. Stents will be fabricated to resemble an acrylic mouth-guard but extended to cover approximately 2mm over gingival margins. Stents will form a seal and rest on the gingiva, but will be relieved on the tooth and tissue side except for the occlusal surfaces to avoid disturbing plaque or gingival tissues. Acrylic stents will abstained from brushing and flossing teeth in one maxillary and one mandibular posterior sextant during a three- week period. Patients will be monitored for safety every week and after the induction of experimental biofilm overgrowth through 21 days
16023930|NCT02710890|Drug|Lacosamide|"Pharmaceutical form: solution for infusion
~Concentration: 10 mg/ml
~Route of Administration: intravenous"
16023931|NCT02710877|Device|Programmed Intermittent bolus|Programmed epidural bolus of 10 ml mixture every 75 minutes, plus patient controlled bolus of 5 ml same mixture; lock-out 15 minutes.
16023932|NCT02710877|Other|Manual epidural bolus|Epidural bolus of 15 ml levobupivacaine and sufentanyl 10 mcg or 5 mcg administered by anesthesist on maternal request.
16023933|NCT02710877|Drug|Levobupivacaine|Levobupivacaine 0,0625% through peridural catheter
16023934|NCT02710877|Drug|Sufentanil 4 mcg|Sufentanil 0,4 mcg/ml through peridural catheter
16023935|NCT02710877|Drug|Sufentanil 5 mcg|Sufentanil 5 mcg through peridural catheter
16023936|NCT02710851|Biological|low dosage HPV Vaccine(1:1)|"Participants would intramuscularly receive low dosage HPV bivalent vaccine with virus-like particles type 6 and 11 at 1:1 ratio.
~All participants would be invited to receive 3 doses vaccine at 0, 1, 6 month."
16023937|NCT02710851|Biological|low dosage HPV Vaccine(1:2)|"Participants would intramuscularly receive low dosage HPV bivalent vaccine with virus-like particles type 6 and 11 at 1:2 ratio.
~All participants would be invited to receive 3 doses vaccine at 0, 1, 6 month."
16023938|NCT02710851|Biological|high dosage HPV Vaccine(1:1)|"Participants would intramuscularly receive high dosage HPV bivalent vaccine with virus-like particles type 6 and 11 at 1:1 ratio.
~All participants would be invited to receive 3 doses vaccine at 0, 1, 6 month."
16023939|NCT02710851|Biological|Hepatitis E vaccine,Hecolin®|Participants would intramuscularly receive Hepatitis E vaccine for 3 doses at 0, 1, 6 month.
16023940|NCT02710838|Device|infrared endoscopy|Firstly use standard white light and narrow-band imaging to observe the lesion, and then inject the contrast medium ICG, after 2 minutes,switch to infrared light to observe, record the image data, then accomplish the examination.
16023941|NCT02710825|Other|Osteopathy|"The treatment begins, if possible, on the body part of the child whose osteopathic score is the highest , with the least elasticity and mobility. Then the other restricted joints will be treated. The set of techniques will be carried out after palpation and appropriate tensioning. The various actions will be carried out on the tissues and joints who have been particularly affected by the operation.
~When a joint or tissue has a restricted mobility in a direction or a specific movement, it will require appropriate and gently manual correction, in order to reduce and improve its functionality."
16023942|NCT02710825|Other|superficial palpatory agreement|The simulated treatment also begins with the body part of the child whose osteopathic score is the highest. Then the other restricted joints will be treated. The set of techniques will be carried out with the same investments as the tests , with a superficial palpatory agreement and without tensioning so that the restricted articulation or tissue will not be corrected
16023943|NCT02710812|Procedure|Local Excision or Wait-and-See|"Local excision can be done both with traditional technique and with endoscopic technique (TEM, TAMIS, etc.).
~The following principles should be respected:
~A gross margin of at least 0.5 cm;
~full-thickness excision including mucosa, submucosa, muscle and peri-rectal fat;
~determination of the specimen on the support by pins at the edges in order to facilitate the interpretation of histological pathologist."
16023944|NCT02710799|Other|Teleconsultation|The teleconsultations will be performed by medical doctors, mostly family physicians, but also internists and endocrinologists. The teleconsultations will follow a structured format to discuss some topics on the disease and access the relevant information (based on the state's protocols). The doubts from the primary care physician will be addressed.
16023945|NCT02710799|Other|Protocol|The informations provided in the referral list will be evaluated through the state's referrals protocols.
16023946|NCT02710786|Procedure|Gastric bypass|Gastric bypass surgery, i.e., small gastric pouch and excluded main stomach
16023947|NCT02710773|Other|Backward Walking Treadmill Training|The intervention will consist of 5 minutes of forward walking (warm-up phase), 10 minutes of backward walking (intervention phase) and 5 minutes of forward walking (cool-down phase). The session will be performed on a treadmill device. The backward training speed will be increase consecutively: during the week 1, the intervention will be performed at 0,8 km/h; during the week 2 the speed will be 1,0 km/h; finally, during the week 3 the speed will be increased till 1,2 km/h.
16023948|NCT02710773|Other|Treadmill Training|The intervention will consist of 20 minutes of forward walking on a treadmill device.
16023949|NCT02710760|Other|Adoption Encouragement Treatment|Households in the Adoption Encouragement Treatment received child nutrition focused guidance on the nutritional and agronomic benefits of Quality Protein Maize (QPM) adoption, and the opportunity to order up to 6 kg of QPM seed to plant in their own fields.
16023950|NCT02710760|Other|Consumption Encouragement Treatment|Households in the Consumption Encouragement Treatment received the same guidance as households in the Adoption Encouragement Treatment, as well as additional guidance on the importance of specifically targeting foods made with QPM to young children and tools to help households keep the grain separate and remember to feed QPM-based foods to the young children.
16023951|NCT02710747|Genetic|CYP2C9;VKORC1|
16023952|NCT02710734|Drug|Methotrexate|Administered Day 1 of each 14 day cycle for 3 cycles
16023953|NCT02710734|Drug|Vinblastine|Administered Day 1 of each 14 day cycle for 3 cycles
16023954|NCT02710734|Drug|Doxorubicin|Administered Day 1 of each 14 day cycle for 3 cycles
16023955|NCT02710734|Drug|Cisplatin|Administered Day 1 of each 14 day cycle for 3 cycles
16023956|NCT02710734|Radiation|Intensity modulated radiation therapy (IMRT)|2.0 Gy per fraction to the whole bladder plus a margin for a total of 32 fractions (64.0 Gy). Radiation will be administered from Monday to Friday
16023957|NCT02710734|Procedure|Transurethral Resection of Bladder tumor|Performed at before and after AMVAC and after chemoradiation and intravesicle therapy
16023958|NCT02710734|Drug|5-FU|Continuous 24hr Intravenous infusion days 1-5 and 16-20 with radiation treatment
16113890|NCT02059213|Drug|Bicalutamide|
16023961|NCT02710721|Other|Control|Participants of the control group will receive an individual nutrition training and in small groups according to the Mediterranean diet.
16023962|NCT02710708|Drug|EE20/DRSP (YAZ, BAY86-5300)|YAZ (DRSP 3 mg/EE 20 µg), oral route, 6 cycles of 28 days per cycle, each cycle comprising 24 days of active tablets followed by 4 days of placebo tablets
16023963|NCT02710695|Behavioral|Control|This group will receive a standardized 10 minute discussion.
16023964|NCT02710695|Behavioral|Intervention|This group will receive a standardized 10 minute discussion
16023965|NCT02710682|Procedure|Mini-open surgery|"This treatment will be administered by an orthopedic surgeon specialized in upper limb surgery.
~Skin disinfection; Local anesthesia (lidocaine 1%).
~Skin incision, slightly anterior to lateral epicondyle.
~Exposure of the plane between the tendon and fascia.
~Extensor Carpi Radialis Longus (ECRL) tendon is lifted to expose the Extensor Carpi Radialis Brevis (ECRB) tendon.
~Excision of diseased tissue of the ECRB tendon.
~ECRL tendon is sutured back to the fascia. The skin is closed.
~Patient is monitored for 30 minutes after procedure."
16023966|NCT02710682|Device|Ultrasound-guided Tendon fenestration|"This treatment will be administered by a fellowship-trained MSK radiologist.
~Patient's elbow at 70 degrees of flexion with the forearm pronated resting on an examination table.
~Skin disinfection. Local anesthesia, skin, superficial fascia and tendon, with lidocaine 1%.
~Using a 22 G needle under continuous ultrasound guidance, several passes (about 20-30) within the abnormal area of the tendon, contacting the bone, until the area softens.
~Patient monitored for 30 minutes, before being discharged."
16023967|NCT02710669|Drug|(R)-propafenone|
16023968|NCT02710669|Drug|(S)-Propafenone|
16023969|NCT02710669|Drug|Placebo|
16023970|NCT02710656|Device|Legflow® balloon|Percutaneous angioplasty performed with a Drug coated balloon (DCB) with Paclitaxel
16023971|NCT02710656|Device|Standard PTA|Percutaneous angioplasty performed with a standard balloon
16023972|NCT02710643|Drug|OFATUMUMAB|8 weekly infusion of 1000 mg total dose
16023973|NCT02710630|Drug|Dabigatran etexilate tablet E1|
16023974|NCT02710630|Drug|Dabigatran etexilate tablet D1|
16023975|NCT02710630|Drug|Dabigatran etexilate tablet C1|
16023976|NCT02710630|Drug|Dabigatran etexilate tablet B1|
16023977|NCT02710630|Drug|Dabigatran etexilate tablet A1|
16023978|NCT02710630|Drug|Dabigatran etexilate capsule|
16023979|NCT02710617|Device|Blood glucose monitoring systems for point-of-care-testing|
16023980|NCT02710604|Drug|CMX157|tablet
16023981|NCT02710604|Drug|TDF|300mg tablet
16023982|NCT02710591|Drug|Rimeporide|"Cohort 1:
~50 mg TID in patients with a body weight ≤ 30kg at Baseline and 75 mg TID in patients with a body weight > 30kg at Baseline
~Cohort 2:
~100mg TID in patients with a body weight ≤ 30kg at baseline and 150 mg TID in patients with a body weight > 30kg at Baseline
~Cohort 3:
~150 mg TID in patients with a body weight ≤ 30kg at baseline and 200 mg TID in patients with a body weight > 30kg at Baseline
~Cohort 4:
~200 mg TID in patients with a body weight ≤ 30kg at Baseline and 300 mg TID mg TID in patients with a body weight > 30kg at Baseline"
16023983|NCT02710578|Drug|Alcohol|A single oral administration of an alcoholic beverage mixed in a 1:3 ratio of alcohol (Vodka) to tonic water to obtain a target BAC of 0.08mg%
16023984|NCT02710578|Drug|Placebo|A single oral administration of a beverage containing tonic water of the same volume as the alcoholic beverage.
16023985|NCT02710565|Other|Cohort|Obtaining additional EBUS TBNA samples for cell culture
16023986|NCT02710552|Drug|Tripliam (perindopril, indapamide, amlodipine)|Fixed combination of perindopril 5 mg, indapamide 1,25 and amlodipine 5 mg
16023987|NCT02710552|Drug|Reaptan (perindopril, amlodipine)|Fixed combination of perindopril 10 mg and amlodipine 5 mg
16023988|NCT02710539|Drug|perindopril, indapamide , amlodipine|Free combination of perindopril 10 mg, indapamide 2,5 mg, amlodipine 10 mg
16023989|NCT02710539|Drug|Tripliam (perindopril, indapamide, amlodipine)|Fixed combination of perindopril 10 mg, indapamide 2,5 mg, amlodipine 10 mg
16023990|NCT02710526|Drug|CAM2038|Long-Acting Subcutaneous Injectable Depot of Buprenorphine
16023991|NCT02710513|Dietary Supplement|Beta-glucans|2 months Mediterranean Diet-based free diet (run-in) + 2 months Mediterranean Diet-based free diet with a daily supplementation of 100 g of beta-glucans pasta (intervention). Medical visits, dietary counselling with food frequency questionnaires administration, blood, urine and feces collection were performed before (T0) and after (T2) the two months of beta-glucans intervention.
16023992|NCT02710500|Drug|rAAVrh74.MHCK7.DYSF.DV|Biological/Vaccine: rAAVrh74.MHCK7.DYSF.DV Recombinant adeno-associated virus carrying a dysferlin transgene under control of a muscle specific MHCK7 promoter.
16023993|NCT02710487|Behavioral|REMSA|Awakening from REM sleep during the last hour of the sleep period
16023994|NCT02710487|Behavioral|NREMSA|Awakening from N2 (NREM) sleep during the last hour of the sleep period
16023995|NCT02710474|Behavioral|Family Nurture Intervention|Family Nurture Intervention is facilitated by specially trained Nurture Specialists in a randomized controlled trial (RCT) model (Part I) or applied unit-wide (either through dedicated staff or bedside nurses in Part II). Under FNI, specialists or nurses will support the parents and facilitate contact between mother and baby during the infant's NICU stay. The intervention involves calming interactions between mother and infant in the isolette via odor exchange, firm sustained touch and vocal soothing, through calming interactions during holding and feeding via the Calming Cycle and through family sessions designed to engage the help and support of family members for the mother.
16023996|NCT02710474|Behavioral|Standard Care|Established routine care provided on the NICU floor by specially trained health care professionals.
16023997|NCT02710461|Dietary Supplement|Mixture of grape pomace and pomegranate pomace|Oral Glucose Tolerance Test
16023998|NCT02710461|Dietary Supplement|Mixture of grape pomace and pomegranate pomace|Oral Glucose Tolerance Test right after taking the mixture of grape and pomegranate polyphenols
16023999|NCT02710461|Dietary Supplement|Mixture of grape pomace and pomegranate pomace|Oral Glucose Tolerance Test ten hours after taking the mixture of grape and pomegranate polyphenols
16024000|NCT02710448|Drug|Metformin|Metformin (Glucophage ®), oral antidiabetic, will be administered as it is usually recommended: engaged during or at the end of the meal in the evening for the single dose 500 mg (Phase 1), the evening and morning for total doses of 1000 mg, 2000 mg and 3000 mg (with, respectively, 2 tab. 500 mg, 2 tab. to 1000 mg, 1 tab. to 1000 mg and 2 tab. to 1000 mg), a fourth dose is also scheduled to stage one (3000 mg / d)
16024001|NCT02710435|Device|Neovasc Reducer System|An aid in the management of chronic refractory angina pectoris
16024002|NCT02710422|Biological|Amniotic Membrane Placement|Amniotic membranes will be placed over the neurovascular bundle after extirpative RARP, and before the urethrovesical anastomosis. The membrane will cut into two longitudinal pieces and it will be placed over each neurovascular bundle separately.
16024003|NCT02710422|Behavioral|EPIC 26|Participants will receive EPIC 26 psychosocial questionnaire at baseline, and post-RARP at protocol-defined intervals.
16024004|NCT02710422|Other|PSA Measurement|Measurement of serum PSA levels every three months (+ 1 month) for first year post surgery, and then annually for 5 years.
16024005|NCT02710422|Behavioral|Sexual History Inventory for Men|SHIM psychosocial questionnaire administered at baseline, and post-RARP at protocol-defined intervals.
16024006|NCT02710409|Biological|Quadrivalent influenza vaccine|0.5 ml/vial, one dose, intramuscular injection on day 0
16024007|NCT02710409|Biological|Trivalent influenza vaccine A|0.5 ml/vial, one dose, intramuscular injection on day 0
16024008|NCT02710409|Biological|Trivalent influenza vaccine B|0.5 ml/vial, one dose, intramuscular injection on day 0
16024009|NCT02710396|Drug|Pembrolizumab|"Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the immunoglobulin G4 (IgG4)/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2 (programmed cell death (PD) proteins).
~Pembrolizumab 200 mg will be administered IV every 3 weeks."
16024010|NCT02710396|Drug|Carboplatin|Carboplatin AUC (area under curve (AUC)) = 5 IV on day 1 every 3 weeks administered for 2 cycles concurrently with cycles 1 and 2 of pembrolizumab.
16024011|NCT02710396|Drug|Nab-paclitaxel|Nab-paclitaxel 100 mg/m2 IV on days 1, 8 and 15 every 3 weeks administered for 2 cycles concurrently with cycles 1 and 2 of pembrolizumab.
16024012|NCT02710396|Drug|Pemetrexed|Pemetrexed 500 mg/m2 IV administered for 2 cycles concurrently with cycles 1 and 2 of pembrolizumab.
16024013|NCT02710357|Procedure|Mandibular Overdenture|Placement of an implant in the mandibular midline.
16024014|NCT02710357|Procedure|Mandibular complete denture|No intervention. Maintenance of the dentures will be done when needed.
16024015|NCT02710344|Behavioral|Telehealth Program|Psychiatric telehealth program, content assigned based on diagnosis, entry to study requires psychiatric instability defined as use of emergency/high cost psychiatric services.
16024016|NCT02710331|Drug|Active Dronabinol|10 mg capsule of Dronabinol will be administered orally.
16024017|NCT02710331|Drug|Placebo|Control: no alcohol, administered for ~80 minutes.
16024018|NCT02710331|Drug|Placebo|Control: Placebo pill (no active cannabinoids) administered orally.
16024019|NCT02710331|Drug|Active Ethanol|Target BrAC of 0.04% reached over 20 minutes and then clamped to maintain this dose for an additional 60 minutes. This dose is equivalent to consuming approximately 2 drinks over 1 hour. Administered over a total of 80 minutes.
16024020|NCT02710318|Behavioral|Electronic immunization alert|Immunization alert in the electronic health record
16024021|NCT02710305|Drug|oral hyoscine butyl bromide tablets plus lidocaine cream|patients will take oral hyoscine butyl bromide 30 minutes before the procedure plus lidocaine anesthetic cream placed into their cervix immediately before the procedure
16024022|NCT02710305|Drug|oral placebo tablets plus placebo cream|patients will take oral placebo 30 minutes before the procedure plus placebo cream placed into their cervix immediately before the procedure
16024023|NCT02710292|Device|Delefilcon A contact lenses|
16024024|NCT02710292|Device|Narafilcon A contact lenses|
16024025|NCT02710279|Behavioral|Trier Social Stress Test (TSST)|"For the TSST the participants are instructed to imagine having applied for their dream job and that they are now invited to a job interview. Three successive phases: (1) A preparation period (3 min), (2) a free speech: explain why you are the best candidate for the job (5 min), (3) a mental arithmetic complex task (5 min). The two tasks (task 2 and 3) are performed in front of a selection committee, three persons dressed in white lab coats, acting in a reserved manner and providing no facial or verbal feedback. Additionally, participants are told that they are video-taped and told that their performance will be evaluated. (in fact, there is no video-tape, just a false camera). After the TSST, patients have to answer to a questionnaire on their smartphone, 5 times a day during 7 days."
16024026|NCT02710279|Device|smartphone|
16024027|NCT02710266|Drug|Preoperative Gabexate Mesilate group|Gabexate Mesilate is administered from the preoperative day and continued for 5 days. 300mg of Gabexate Mesilate is mixed with 500cc of 5% dextrose water and administered at 40cc/hr for 12 hours each day.
16024028|NCT02710266|Drug|Intraoperative Gabexate Mesilate group|Gabexate Mesilate is administered from the operative day and continued for 5 days. 300mg of Gabexate Mesilate is mixed with 500cc of 5% dextrose water and administered at 40cc/hr for 12 hours each day.
16024029|NCT02710266|Drug|hepatectomy with dextrose water|Gabexate Mesilate is not administered. As placebo, 500cc of 5% dextrose water is administered at 40cc/hr for 12 hours
16024030|NCT02710253|Radiation|External Beam Radiation Therapy|Undergo EBRT
16024031|NCT02710253|Other|Laboratory Biomarker Analysis|Correlative studies
16024032|NCT02710253|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
16024035|NCT02710227|Other|(PSQI), (STQ).|Sleep quality, sleep timing parameters and circadian preference were evaluated using (PSQI), (STQ).
16024036|NCT02710214|Drug|Tissue Selective Estrogen Complex|Once-daily dosing of Duavee for 8 weeks.
16024037|NCT02710214|Drug|Placebo|Once-daily dosing of placebo for 8 weeks
16024038|NCT02710201|Behavioral|Descriptive Social Norm|
16024039|NCT02710201|Behavioral|Descriptive-plus-Injunctive Social Norm|
16024040|NCT02710188|Drug|HTL0009936 modified release|HTL0009936 modified release
16024041|NCT02710188|Drug|HTL0009936 immediate release|HTL0009936 immediate release
16024042|NCT02710175|Other|serum TSH level|
16024068|NCT02710097|Drug|Active Oral Ethanol|0.4 g/kg ethanol in orange juice or ginger ale to reach a target BrAC of approximately 0.04%. This dose is equivalent to approximately 2 standard drinks over 1 hour. Approximately 4 drinks, each administered over approximately 10 minutes.
16024069|NCT02710097|Drug|Placebo|No active cannabinoids. Administered over 20 minutes via a vaporizer.
16024070|NCT02710084|Drug|Oxytocin|Intranasal oxytocin
16024043|NCT02710162|Device|Micro Mouth Pressure Meter|The participant will be seated with the nose occluded using a nose clip. After inhaling to total lung capacity, the participant will place his or her lips around the mouthpiece and blow out as forcefully as possible. A flanged rubber mouthpiece will be used to overcome the inability of some individuals to create tight lip seal due to facial muscle weakness. Three trials will be performed and the patients highest maximum inspiratory pressure (MIP) and maximum expiratory pressure (MEP) used.
16024044|NCT02710162|Device|Iowa Oral Performance Instrument|The Iowa Oral Performance Instrument (IOPI) is a device that measures the peak pressure performance of lingual strength and endurance via the action of a bulb placed on the hard palate.
16024045|NCT02710162|Device|Electrical Impedance Myography|The SFB7 Bioimpedance device measures the function of the tongue by calculating measures of reactance, resistance and phase once a custom electrode array is placed on the midline of the subject's tongue for approximately 2 seconds.
16024046|NCT02710162|Drug|Capsaicin|"A capsaicin challenge with three randomized blocks of 0, 50, 100, 200, and 500 μM capsaicin. The capsaicin will be dissolved in a vehicle solution consisting of 80% physiological saline, and 20% ethanol. Participants will be given the instruction cough if you need to prior to capsaicin delivery.The solution will be administered automatically upon detection of an inspired breath and there will be a minimum of one minute between each trial. This is to test the reflexive cough testing for upper airway sensitivity and motor thresholds."
16024047|NCT02710162|Procedure|Videofluoroscopic Swallowing Study|Videofluoroscopic swallowing study will be performed to measure the oropharyngeal swallowing.
16024048|NCT02710162|Procedure|Pulmonary Function Testing|Pulmonary Function testing will be performed using conventional methods and will include the following outcomes: forced vital capacity (FVC), sniff nasal inspiratory pressure (SNIP), peak expiratory flow (PEF), forced expiratory volume (FEV1) expressed as a percentage of predicted values.
16024049|NCT02710162|Other|Swallowing Related Quality of Life Questionnaire|Swallowing Quality of Life Questionnaire (SWAL-QOL) will be used for participant reporting of swallow-related quality of life.
16024050|NCT02710162|Other|Functional Oral Intake Scale|The Functional Oral Intake Scale (FOIS) will be used for participants to report their food intake habits.
16024051|NCT02710162|Other|Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised|The Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised (ALSFRS-R) will be used to track global disease progression in participants.
16024052|NCT02710162|Other|Eating Assessment Tool-10|The Eating Assessment Tool-10 will be used for participant reporting of swallowing system severity.
16024053|NCT02710162|Other|Communicative Effectiveness Survey|The Communication Effectiveness Survey (CES) will be used for participant reporting of communication abilities across different speech contexts.
16024054|NCT02710162|Other|The Center for Neurologic Studies Bulbar Function Scale|The Center for Neurologic Studies Bulbar Function Scale (CNS-BFS) will be used to report bulbar function in study participants.
16024055|NCT02710149|Biological|Anti-CD20-CAR-transduced T cells|Patients receive autologous-derived CD20-targeted CAR-T cells on day 1, 2 after receiving lymphodepleting chemotherapy.
16024056|NCT02710136|Biological|Glycerinated German Cockroach Allergenic Extract|"Participants will receive escalating doses intranasally. Briefly: per protocol- Phase 1a NAC: N=10 cockroach sensitive adults with asthma will undergo nasal allergen challenge with dose escalation (up to 8 doses per protocol). Phase 1b: Phase 1a subjects will have repeat NAC with dose escalation (up to 8 doses).
~Phase 2: N=25 cockroach sensitive children with asthma (ages 8 - 14 years) will undergo NAC with doses determined by Phase 1a data (e.g., symptoms and safety data)."
16024057|NCT02710123|Other|Sub-Threshold exercise prescription|Participants will be given a prescription to exercise at 80% of their threshold HR for symptom exacerbation. HR Threshold will be monitored weekly and exercise level increased accordingly.
16024058|NCT02710123|Other|Structured stretching prescription|Participants will be given a prescription for daily stretching lasting approximately 20 minutes.
16024059|NCT02710110|Device|PowerLung trainer|PowerLung trainer will be utilized which has both an inspiratory and expiratory loading capacity for training. A single daily training session will consist of three sets of 10 repetitions for a total of 30 inspiratory repetitions and 30 expiratory repetitions (i.e. 60 repetitions) for 5 days a week, for 3 months.
16024060|NCT02710110|Device|Micro Mouth Pressure Meter|The participant will be seated with the nose occluded using a nose clip. After inhaling to total lung capacity, the participant will place his or her lips around the mouthpiece and blow out as forcefully as possible. A flange rubber mouthpiece will be used to overcome the inability of some individuals to create tight lip seal due to facial muscle weakness. Three trials will be performed and the patients highest Maximum Inspiratory Pressures (MIP) and Maximal Expiratory Pressure (MEP) used.
16024061|NCT02710110|Procedure|Pulmonary Function Testing|Pulmonary Function testing will be performed using conventional methods and will include the following outcomes: forced vital capacity (FVC), sniff nasal inspiratory pressure (SNIP), peak expiratory flow (PEF), forced expiratory volume (FEV1) expressed as a percentage of predicted values.
16024062|NCT02710110|Procedure|Videofluoroscopic swallowing study|Videofluoroscopic swallowing study will be performed to measure the oropharyngeal swallowing.
16024063|NCT02710110|Other|Swallowing Quality of Life Questionnaire|Swallowing Quality of Life Questionnaire (SWAL-QOL) will be used for participant reporting of swallow-related quality of life.
16024064|NCT02710110|Device|Iowa Oral Pressure Instrument|The IOPI is a device that measures the peak pressure performance of lingual strength and endurance via the action of a bulb placed on the hard palate.
16024065|NCT02710110|Drug|Capsaicin|"A capsaicin challenge with three randomized blocks of 0, 50, 100, 200, and 500 μM capsaicin. The capsaicin will be dissolved in a vehicle solution consisting of 80% physiological saline, and 20% ethanol. Participants will be given the instruction cough if you need to prior to capsaicin delivery.The solution will be administered automatically upon detection of an inspired breath and there will be a minimum of one minute between each trial. This is to test the reflexive cough testing for upper airway sensitivity and motor thresholds."
16024066|NCT02710097|Drug|Active inhaled cannabis|"~450 mg of active cannabis, which is roughly equivalent to smoking 1/4 of a marijuana cigarette, or joint. Administered over 20 minutes via a vaporizer."
16024067|NCT02710097|Drug|Placebo|Approximately 4 drinks of orange juice or ginger ale covered with a trace amount of ethanol on the surface, each administered over approximately 10 minutes.
16024071|NCT02710084|Drug|Saline|Placebo
16113891|NCT02059213|Drug|Zoladex|
16024073|NCT02710071|Drug|Hydrochlorothiazide|Hydrochlorothiazide 12.5 mg then hydrochlorothiazide 25 mg
16024074|NCT02710058|Behavioral|one-time qualitative assessment|The study involves a one-time qualitative assessment to explore key cultural influences on AMBER breast cancer survivors' health behavior. We will focus on self-efficacy in healthcare, coping with breast cancer, social networks of support, and culturally-sensitive support groups. The study investigator will administer questions from the structured interview guide, estimated to take 90 minutes.
16024075|NCT02710045|Biological|Measles Vaccine at 9 months of age|Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 9 months of age
16024076|NCT02710045|Biological|DTP Vaccine at 9 months of age|Single intramuscular (i.m.) dose of diphtheria-tetanus-whole cell pertussis vaccine (Serum Institute of India Ltd.) into the thigh at 9 months of age
16024077|NCT02710045|Biological|Measles Vaccine at 18 months of age|Single standard intramuscular (i.m.) dose of measles vaccine (MV) (Edmonston Zagreb strain, Serum Institute of India Ltd., Pune, India) into the deltoid at 18 months of age
16024078|NCT02710032|Behavioral|Social Network-Based Adherence Intervention|Participants in clusters randomized to the intervention arm will be asked to attend a series of weekly group workshops emphasizing a collective approach to HIV prevention and mutual support for PrEP adherence.
16024079|NCT02710032|Behavioral|Social Media Platform|ii) Social Media Platform: The social media component of the intervention will include structured internet platforms designed to educate, motivate, and promote discussions of PrEP adherence within the participant network, unstructured participant-generated interactions to articulate and reinforce newly developed social norms within the network, and practical tools to support daily PrEP adherence.
16024080|NCT02710019|Other|Back to Reality Series Video Games|Back to Reality Series are a psycho-educational video games that provide information about psychosis and marijuana use from the perspective of 'Harry': a character who experiences problems with both issues. The aim is for players to learn how to detect some signs of psychosis and where to seek help for mental health and addictions problems.
16024081|NCT02710019|Other|Control Video Game|The control video game consists of digital puzzles and spelling game about pop culture. The control games does not have any content related to mental health and addictions problems
16024082|NCT02710006|Procedure|Sonohysterography|Sonohysterography, also known as saline infusion sonography, is a special, minimally invasive ultrasound technique. Sonohysterography is a technique in which fluid is injected through the cervix into the uterus, and ultrasound is used to. It provides pictures of the inside of a woman's uterus. Three-dimensional sonohysterography is based on volumetric scanning of uterus and its cavity during saline infusion.
16024083|NCT02709993|Biological|TAPA-pulsed DC vaccine|A cycle of low-dose cyclophosphamide (100mg/day) by mouth for 5 days starting seven 7 days prior to the DC vaccine cycle to reduce Treg activity. Low-dose cyclophosphamide will be taken every 14 days for six 6 cycles. A total of 6 vaccines containing 1 x 10^7 TAPA-pulsed DC will be administered SQ every 14 days. The DC vaccine is given on Day 1 of the DCV cycle plus low-dose GM-CSF 50mcg/day SQ x 5 days (Day 1 to Day 4). GM-CSF is administered for 5 days to increase monocyte production and dendritic cell precursors to optimize immune responses.
16024084|NCT02709980|Behavioral|Sleep Education|The sleep education intervention will parallel the CBT-I intervention in number, format (in-person) and length of sessions. It is intended to disseminate information about sleep including sleep hygiene information that is widely available. Subjects will be instructed to read and review 6 publications from the American Academy of Sleep Medicine; sessions will review the material to ensure complete access to the information.
16024085|NCT02709980|Behavioral|Cognitive Behavior Therapy for Insomnia|Treatment will involve a standardized 6-session intervention, with demonstrated efficacy, that combines education and behavioral techniques to reduce insomnia. The core components include (1) education about sleep and insomnia, stimulus control, and sleep restriction (session 1); (2) sleep hygiene education (session 2); and 3) relaxation training, cognitive therapy, adherence monitoring, adjusting the recommended sleep-wake schedule, and addressing any problems in implementation (session 3-5). The final session will include a review of treatment content and relapse prevention.
16024086|NCT02709967|Other|Material support|Writing materials
16024087|NCT02709967|Other|Economic|Economic support (monthly cash transfer to girls, annual grant to guardians, and payment of school fees in grade 8 and 9)
16024088|NCT02709967|Behavioral|Community dialogue|Community dialogue (youth club meetings, community and parent meetings)
16024089|NCT02709954|Drug|Active inhaled delta-9-THC|"Low dose THC (~4 mg), dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4 of a marijuana cigarette, or joint. Administered over 20 minutes via a vaporizer."
16024090|NCT02709954|Drug|Placebo|Control: Approximately 4 drinks of orange juice or ginger ale covered by a trace amount of ethanol on the surface, each administered over approximately 10 minutes.
16024091|NCT02709954|Drug|Placebo|Control: No active THC. Administered over 20 minutes via a vaporizer. approximately 10 minutes.
16024092|NCT02709954|Drug|Active Oral Ethanol|0.4 g/kg ethanol in orange juice or ginger ale to reach a target BrAC of approximately 0.04%. This dose is equivalent to consuming approximately 2 standard drinks over 1 hour. Approximately 4 drinks, each administered over approximately 10 minutes.
16024093|NCT02709941|Other|Inspiratory muscle strength training|Breathing training designed to augment inspiratory muscle strength, and thus targeted muscle groups may benefit from improved force generating capability result in improved breathing.
16024094|NCT02709941|Other|Placebo|
16024095|NCT02709928|Drug|TD-0714|
16024096|NCT02709928|Drug|Placebo|
16024097|NCT02709915|Other|Breakfast Diet (Bdiet)|The Breakfast Ddiet consist of high-energy breakfast, medium-sized lunch and reduced in energy dinner, with distribution of calories: breakfast 50%, lunch 33% and dinner 17%. In this diet, the investigators will evaluate at baseline and at the end of 12 weeks of diet intervention, the diet efficacy on reducing HbA1c, the total daily insulin dose requirements (TDID), the efficacy on reducing body weight, fasting plasma glucose (FPG) and overall glycemic excursion assessed with continuous monitoring system. The investigators will assess also the Clock Genes mRNA expression in white blood cells. at baseline and after 12 weeks of diet intervention
16024146|NCT02709603|Drug|hyoscine butyl bromide|oral hyoscine butyl bromide; 2 tablets (buscopan 10 mg) 30 minutes before the procedure
16024147|NCT02709603|Drug|placebo|oral placebo; 2 tablets 30 minutes before the procedure
16113892|NCT02059213|Drug|Lupron Depot|
16024098|NCT02709915|Other|6Meal Diet (6Mdiet|The 6meal diet (6Mdiet) will consist in the traditional antidiabetic diet, consuming 6 small meals: breakfast, lunch and dinner and 3 snacks, with caloric distribution: breakfast 20%, lunch 25%, dinner 25% and 10% each of the 3 snacks. In this diet, the investigators will evaluate at the beginning and at the end of the study (12 weeks), the diet effects on reducing HbA1c, total daily insulin dose requirements (TDID), and the diet efficacy on reducing body weight, fasting plasma glucose (FPG) and overall glycemic excursion, using continuous monitoring system, The investigators will assess also at baseline and at the end of the diet intervention the Clock Genes mRNA expression in white blood cells.
16024099|NCT02709902|Drug|Adapalene/BP gel, 0.3%/2.5%|Gel
16024100|NCT02709902|Drug|EPIDUO® FORTE|Gel
16024101|NCT02709902|Drug|Placebo|Gel
16024102|NCT02709889|Drug|Rovalpituzumab tesirine|
16024103|NCT02709889|Drug|Dexamethasone|Dexamethasone will be provided through a participant's local prescription by Investigator or other provider (i.e., dexamethasone will not be provided by the Sponsor).
16024104|NCT02709876|Biological|Stem Cell Transplantation|Bone marrow-derived CD34+, CD133+, CD271+ stem cells in 1.0 ml normal saline will be injected into the vitreous cavity.
16024105|NCT02709863|Drug|Sevoflurane|1-1.5 MAC, inhalation route, during operation
16024106|NCT02709863|Drug|Desflurane|1-1.5 MAC, inhalation route, during operation
16024107|NCT02709863|Drug|Propofol|6-10 mg/kg/h, iv infusion, during operation
16024108|NCT02709850|Drug|IONIS ANGPTL3-LRx|
16024109|NCT02709850|Drug|Placebo|0.9%NaCl, water, riboflavin
16024110|NCT02709837|Other|Nutritional|
16024111|NCT02709824|Drug|Chlorhexidine gluconate with ADS|Oral rinsing, twice a day, for 21 days
16024112|NCT02709824|Drug|Chlorhexidine gluconate without ADS|Oral rinsing, twice a day, for 21 days
16024113|NCT02709811|Drug|Electrochemotherapy|
16024114|NCT02709798|Drug|Shenfu Injection|
16024115|NCT02709798|Drug|5% Glucose Injection|
16024116|NCT02709785|Drug|SmartMouth Clinical DDS mouthrinse|Subjects use SmartMouth Clinical DDS mouth rinse for six weeks.
16024117|NCT02709785|Drug|0.12% chlorhexidine rinse|Subjects use chlorhexidine mouth rinse for six weeks.
16024118|NCT02709785|Drug|Placebo rinse|Subjects use placebo mouth rinse for six weeks. The placebo rinse is the same as SmartMouth Clinical DDS, but without the active ingredients.
16024119|NCT02709772|Behavioral|Electronic Record Alert|Electronic alert within the medical record indicating the ordered test or treatment may be inappropriate. The provider can indicate why the test or treatment is appropriate and complete the order.
16024120|NCT02709759|Behavioral|Motivational intervention|Involves 60 minutes of counseling delivered by videoconferencing. Provides feedback on drinking and HIV and related behaviors.
16024121|NCT02709759|Behavioral|Brief Advice|Involves 5-10 minutes of brief counseling to reduce drinking
16024122|NCT02709759|Behavioral|Interactive text messaging|Involves receiving daily text messages that enable participants to track their drinking and related consequences. Provides feedback on drinking and allow setting of goals.
16024123|NCT02709746|Drug|Vortioxetine 10 mg/day|10 mg/day, encapsulated tablet (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed
16024124|NCT02709746|Drug|Vortioxetine 20 mg/day|20 mg/day, encapsulated tablet (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed
16024125|NCT02709746|Drug|Fluoxetine 20 mg/day|20 mg/day, encapsulated tablet (with addition of lower initial dose levels). Based on tolerability the dose may be reduced by 10 mg/day. No dose increase will be allowed
16024126|NCT02709746|Other|Placebo|Encapsulated tablet
16024127|NCT02709733|Behavioral|VR Motivation Training|Computerized treatment with a virtual reality-based motivation training program, administered for 1 hour per week for 8 weeks.
16024128|NCT02709720|Drug|Vinorelbine|Cycle 1 and 2 50 mg/day, (Monday, Wednesday and Friday)
16024129|NCT02709720|Drug|Cisplatin|Cycle 1 and 2 day 1, 80 mg/m2
16024130|NCT02709720|Drug|Vinorelbine|Cycle 3 and 4 30 mg/day, (Monday, Wednesday and Friday)
16024131|NCT02709720|Drug|Cisplatin|Cycle 3 and 4 day 1, 80 mg/m2
16024132|NCT02709720|Radiation|Radiotherapy|concomitant therapy during cycles 3 and 4. Total dose: 66Gy
16024133|NCT02709707|Device|Blood glucose monitor|
16024135|NCT02709681|Other|Physician standard-of-care in SCD patients|
16024136|NCT02709668|Dietary Supplement|Enlyte|gel cap of reduced B vitamins
16024137|NCT02709668|Other|placebo|identical to Enlyte
16024138|NCT02709655|Drug|Vortioxetine 10 mg/day|"10 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels).
~Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed"
16024139|NCT02709655|Drug|Vortioxetine 20 mg/day|"20 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels).
~Based on tolerability the dose may be reduced by 5 mg/day. No dose increase will be allowed"
16024140|NCT02709655|Drug|Fluoxetine 20mg/day|"20 mg/day, encapsulated tablet, orally (with addition of lower initial dose levels).
~Based on tolerability the dose may be reduced by 10 mg/day. No dose increase will be allowed"
16024141|NCT02709655|Other|Placebo|Encapsulated tablet, orally
16024142|NCT02709642|Behavioral|Deposit Contract|"A deposit contract (DC) is an agreement in which study participants puts their own money at risk, with the goal of earning it back by achieving a goal, in this case maintaining prior weight loss. If DC participants successfully maintain their weight, they get their money back. If they are not successful, they lose their money. For each 10 week period for one year, DC participants will make a deposit of at least $100 but will be allowed to increase their contribution if they would prefer."
16024143|NCT02709629|Behavioral|Individualized and adaptive computerized cognitive training|
16024144|NCT02709629|Behavioral|Active control|
16024145|NCT02709616|Biological|Personalized cellular vaccine|Biological: DC-based cellular vaccine. Subjects will undergo surgical resection and standard 6-week chemo/radiotherapy and cycles of TMZ treatment. They will receive biweekly cellular vaccines.
16024148|NCT02709590|Drug|diclofenac potassium + lidocaine|patients will have of oral diclofenac potassium 60 minutes before the procedure plus lidocaine anesthetic cream placed into their cervix immediately before HSG
16024149|NCT02709590|Drug|placebo|patients will have of oral placebo tablet 60 minutes before the procedure plus placebo cream placed into their cervix immediately before HSG
16024150|NCT02709577|Device|EndoBarrier Gastrointestinal Liner|The EndoBarrier is a single use, implant consisting of a tube of composite material which is placed in the proximal section of the duodenum. The implant is fixed in place with the aid of a metal anchor. The device is delivered via an endoscope. The implant facilitates the passage of food from the stomach through the tube to the proximal section of the jejunum.
16024151|NCT02709577|Other|Sham: endoscopy and standard of care|Sham subjects had an endoscopic procedure and then received standard of care treatment of their diabetes
16024152|NCT02709564|Drug|Misoprostol 400 sublingual|patients will take 2 tablets of sublingual misoprostol 400 microgram 3 hours and 1 hour before the surgery
16024153|NCT02709564|Drug|placebo 400 sublingual|patients will take 2 tablets of sublingual placebo 400 microgram 1 hour before the surgery
16024154|NCT02709551|Behavioral|HRV_Bfb|
16024155|NCT02709551|Behavioral|MBI|
16024156|NCT02709551|Behavioral|MBI_HRV_Bfb|
16024157|NCT02709538|Drug|GSP 301 NS|FDC of olopatadine HCl and mometasone furoate: 2 spray in each nostril twice daily for 52 weeks
16024158|NCT02709538|Drug|GSP 301 Placebo NS pH 3.7|2 spray in each nostril twice daily for 52 weeks
16024159|NCT02709538|Drug|GSP 301 Placebo NS pH 7.0|2 spray in each nostril twice daily for 52 weeks
16024160|NCT02709525|Drug|hyaluronic acid|
16024161|NCT02709525|Other|Placebo|
16024162|NCT02709512|Drug|ADI-PEG 20 plus Pem Cis|Investigational Drug in combination approved standard of care treatment for this indication
16024163|NCT02709512|Other|Placebo plus Pem Cis|Placebo in combination approved standard of care treatment for this indication
16024164|NCT02709499|Device|0J LLLT|perform with the machine off
16024165|NCT02709499|Device|6J LLLT|irradiation will be perform with 4J
16024166|NCT02709486|Drug|Tanezumab|2.5 mg
16024167|NCT02709486|Drug|Tanezumab|5 mg
16024168|NCT02709486|Drug|Placebo|Placebo
16024169|NCT02709473|Drug|Propofol|Propofol will be used in either two arms. The injection sequence will be changed. In propofol arm of the study, general anesthesia will be started with 2 mg/kg propofol administered within 15 seconds. And, then remifentanil will be given. In remifentanil arm of the study, 2 mg/kg propofol will be applied within 15 seconds following remifentanil injection.
16024170|NCT02709473|Drug|Remifentanil|Remifentanil will be used in either two arms. The injection sequence will be changed. In remifentanil arm, general anesthesia will be started with 2 μg/kg remifentanil administered within 30 seconds. And then propofol will be given. In propofol arm of the study the same dose will be applied within 30 seconds following propofol administration.
16024171|NCT02709473|Drug|Rocuronium|Rocuronium will be used for either two study arms. Rocuronium will be given in a 0.8 mg/kg dosage in the first study subject. And then, if the intubation condition is acceptable, the dose of the rocuronium will be decreased by 0.1 mg/kg for the next patient. Otherwise, if the intubation condition is not acceptable, the rocuronium dosage will be increased by 0.1 mg/kg for the next patient. This will be continue for ten crossover points (the point that turn from unsuccessful intubation to successful intubation).
16024172|NCT02709460|Procedure|Lateral occlusion|Lateral occlusion close to the internal Iliac artery
16024173|NCT02709460|Procedure|Cervical occlusion|Cervical occlusion of the uterine artery
16024174|NCT02709447|Behavioral|Date SMART|Skills-based, group prevention program targeting emotion regulation and interpersonal skills using a cognitive-behavioral framework.
16024175|NCT02709447|Behavioral|Health Promotion|Psycho-educational group prevention program targeting knowledge and skills only
16024176|NCT02709434|Behavioral|Psychoeducational programme|Activity diary analysis and a structured programme of intervention
16024177|NCT02709434|Other|Standard care|Usual IBD management
16024178|NCT02709395|Device|Navina Smart|Transanal irrigation at the same frequency as subject used before enrollment.
16024179|NCT02709382|Drug|Cefepime and Tazobactam combination|
16024180|NCT02709369|Device|HIRREM|HIRREM is a noninvasive, closed-loop, allostatic, acoustic stimulation neuro-technology to facilitate recipient-unique relaxation, auto-calibration, and self-optimization of cortical neural oscillations by reflecting auditory tones in near real time. After an initial HIRREM assessment, evaluating patterns of brain electrical rhythms, subjects get a series of 90-120 minute HIRREM sessions, including 5 to 9 individualized protocols. A protocol is a combination of sensor montage and specific software design, during which dominant brain frequencies, recorded at high spectral resolutions, are translated to audible tones, and reflected back via earphones with as little as 8 milliseconds delay. Protocols are received sitting or reclining in a chair, some with eyes open, others eyes closed.
16024181|NCT02709356|Dietary Supplement|1-month of 60-40 MCT oil|1-month supplementation of 30 g MCT oil (60% C10 + 40% C8)/day
16024182|NCT02709356|Dietary Supplement|1-month of C8 MCT oil|1-month supplementation of 30 g MCT oil (100% C8)/day (1-month of C8 MCT oïl)
16024183|NCT02709343|Drug|Bone-marrow derived MSCs|Allogeneic ex vivo expanded, bone marrow-derived mesenchymal stromal cells
16024184|NCT02709343|Drug|Placebo|Placebo product visually very similar to mesenchymal stromal cells
16024185|NCT02709330|Drug|Lunasin Regimen|LunaRich X Capsules, Reliv Now, ProVantage
16024186|NCT02709330|Other|Historical control|Matched historical controls will be identified from the PatientsLikeMe database.
16024187|NCT02709317|Behavioral|Prevention Intervention|
16024188|NCT02709317|Behavioral|Brief Intervention|
16024189|NCT02709304|Drug|Lidocaine gel|Gel used for insertion of urinary catheter containing local anesthetic to determine if patients have less discomfort postoperatively when this is used
16024190|NCT02709304|Drug|standard gel|Standard gel that is used to insert a urinary catheter that does not contain local anesthetic
16024191|NCT02709291|Behavioral|behavioral parent training|Parents receive up to 6 sessions of the Family Check-Up program
16024192|NCT02709291|Behavioral|interventionist training|Interventionists are trained in the delivery of the Family Check-Up program and deliver sessions to families in their community
16026150|NCT02695420|Drug|Placebo|oral tablet
16024193|NCT02709278|Biological|BCG|BCG SSI (Groups 1A, 1B, 1C and 1D) & BCG Bulgaria (InterVax) (Groups 2A, 2B, 2C, 2D and 2E)
16024194|NCT02709278|Other|Saline placebo|Saline placebo
16024195|NCT02709265|Drug|amikacin/fosfomycin|single aerosolized dose
16024196|NCT02709252|Device|PVI and deltaPP after trendelenburg position change|Comparison of hemodynamic parameters during surgery after position change
16024200|NCT02709213|Diagnostic Test|Diagnostic|Determination of pathogens and faecal calprotectin in the stools
16024201|NCT02709200|Drug|Dexmedetomidine|
16024202|NCT02709187|Drug|DP-R208|Investigational product is prescribed to all of randomized subjects
16024203|NCT02709187|Drug|Candesartan cilexetil|Investigational product is prescribed to all of randomized subjects
16024204|NCT02709187|Drug|Rosuvastatin|Investigational product is prescribed to all of randomized subjects
16024205|NCT02709174|Procedure|blood draw|blood draw
16024206|NCT02709161|Behavioral|real-time fMRI neurofeedback: Amygdala|Participants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories
16024207|NCT02709161|Behavioral|real-time fMRI neurofeedback: HIPS|Participants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories
16024208|NCT02709148|Device|Activa PC+S|DBS
16024209|NCT02709122|Device|ThoraQuik atraumatic set for pneumothorax decompression|pneumothorax decompression in case it is found in accordance with the actually recommendations
16024210|NCT02709109|Drug|VX-371 + HS|
16024211|NCT02709109|Drug|Hypertonic saline|
16024212|NCT02709109|Drug|Placebo|
16024213|NCT02709109|Drug|Orkambi|
16024214|NCT02709109|Drug|VX-371|
16024215|NCT02709096|Drug|BPX-01, 1% Topical Gel|topical gel, applied to the forehead, cheeks, nose and chin
16024216|NCT02709096|Drug|BPX-01 Vehicle Gel|topical gel, applied to the forehead, cheeks, nose and chin
16024217|NCT02709083|Drug|Dasatinib|Given orally
16024218|NCT02709083|Drug|Imatinib Mesylate|Given orally
16024219|NCT02709083|Drug|Nilotinib|Given orally
16024220|NCT02709070|Procedure|resection|hepatectomy for HCC
16024221|NCT02709070|Procedure|highly-purified CTL|hepatectomy first, followed by highly-purified CTL treatment
16024222|NCT02709057|Behavioral|Lifestyle intervention|Life-style intervention includes 7-9 group sessions (two additional group sessions for participants whose body mass index exceeds 28 kg/m2) on diet (healthy diet according to Nordic and Finnish nutrition recommendations emphasizing appropriate energy intake, meal frequency, consumption of fruits, vegetables and berries, quality of dietary fat and carbohydrates, including sugar and fiber intake) and physical exercise (brisk walking a minimum of 30 minutes per day at least five days a week or other types of exercise, e.g. cycling, cross-country skiing, housework such as leafs raking, resistance training).
16024223|NCT02709044|Drug|Ringer lactate|
16024224|NCT02709031|Drug|Cicletanine + magnesium|"Cicletanine is an orally-dosed furopyridine drug launched or hypertension in France in 1988 (and soon thereafter in Germany by IPSEN. While the drug's maximum tolerated dose is not known, the principal concern (and so far only material concern) at higher doses is the decrease in levels of sodium and potassium. Trials so far have take n the drug up to 400 mg QD (once daily); it was well tolerated at that dose. The drug has had an excellent safety profile in its ~1.8 million patient-years of post-launch experience,
~Magnesium is being added to cicletanine in order to decrease losses of potassium and sodium, thereby enhancing cicletanine's safety at higher doses."
16024225|NCT02709031|Drug|Cicletanine|Cicletanine is an orally-dosed furopyridine drug launched or hypertension in France in 1988 (and soon thereafter in Germany by IPSEN. While the drug's maximum tolerated dose is not known, the principal concern (and so far only material concern) at higher doses is the decrease in levels of sodium and potassium. Trials so far have take n the drug up to 400 mg QD; it was well tolerated at that dose. The drug has had an excellent safety profile in its ~1.8 million patient-years of post-launch experience,
16024226|NCT02709018|Drug|losartan|Angiotensin receptor blocker (ARB)
16024227|NCT02709018|Drug|Placebo|Placebo
16024228|NCT02709005|Drug|5% Monolaurin Vaginal Gel|Monolaurin Vaginal Gel is a clear and colorless, non-sterile glycol-based gel for vaginal administration , and commonly referred to as glycerol monolaurate (GML). Each subject will receive intravaginal gel twice daily for three successive days for a total of 6 doses. There will be 3 clinic visits over 30 days.
16024229|NCT02709005|Other|Placebo|The placebo gel is a clear to opaque, colorless to light gray, non-sterile glycol-based gel for vaginal administration. The placebo gel contains the same excipients as the Monolaurin vaginal gel. Each subject will receive intravaginal gel twice daily for three successive days for a total of 6 doses. There will be 3 clinic visits over 30 days.
16024230|NCT02708992|Drug|Azithromycin|
16024231|NCT02708992|Drug|Cefixime|
16024232|NCT02708979|Other|University exam-period|This visit takes place one week prior to an exam at the university assuming that students will be stressed in this period.
16024233|NCT02708979|Other|University non-exam-period|This visit takes place several weeks post and prior to an exam at the university assuming that students will not be stressed in this period.
16024347|NCT02708173|Biological|One dose of Quadrivalent Influenza Virus Vaccine|
16024234|NCT02708966|Drug|Gymnema Sylvestre|Gymnema Sylvestre, 300mg capsules 2 times daily with the first bite of breakfast and dinner
16024235|NCT02708966|Drug|Placebo|Placebo, 300mg capsules 2 times daily with the first bite of breakfast and dinner
16024236|NCT02708953|Procedure|Thoracic manipulation (Manipulation Group)|Manipulation techniques will include: CT junction manipulation seated and supine, upper thoracic manipulation, middle thoracic spine manipulation in seated and supine, middle thoracic spine manipulation in prone, thoracic active range of motion exercise and instruction to maintain usual activity level within the limits of pain.
16024237|NCT02708953|Procedure|Thoracic Manipulation (Control wait-list)|Manipulation techniques will include: CT junction manipulation seated and supine, upper thoracic manipulation, middle thoracic spine manipulation in seated and supine, middle thoracic spine manipulation in prone, thoracic active range of motion exercise and instruction to maintain usual activity level within the limits of pain.
16024238|NCT02708940|Other|Participatory technology development|Creating mobile support tools by patients and their therapists
16024239|NCT02708940|Other|Usual Care|Usual care as part of the UCLA PHP and IOP programs
16024240|NCT02708927|Other|Clinical evaluation|• Clinical assessment : Expanded Disability Status Scale (EDSS), ambulation test. Medications will be recorded.
16024241|NCT02708927|Other|Cognitive evaluation|• Neuropsychological, psychological, social and social cognitive evaluation
16024242|NCT02708914|Biological|UB-851|UB-851 (rhEPO) has been developed as a biosimilar product to Eprex®.
16024243|NCT02708914|Biological|Eprex|Eprex® is chosen as the comparator.
16024244|NCT02708901|Dietary Supplement|Vivomixx®|Two packets (900 billions bacteria) per os (P.O.) daily x 1 month and one packet (450 billions bacteria) P.O. daily x 5 months
16024245|NCT02708901|Dietary Supplement|Placebo|Two packets (4,4 grams of maltose and silicon dioxide x 2) P.O. daily x 1 month and one packet (4,4 grams of maltose and silicon dioxide) P.O. daily x 5 months
16024246|NCT02708888|Other|Trunk training|The experimental group receives 16 hours of additional trunk training (4 days/week, 4 weeks) focusing on trunk muscle strength, coordination and selective movements executed on stable and unstable surfaces.
16024247|NCT02708888|Other|Cognitive exercises|The control group will be receiving the same amount of repetitive cognitive exercises within arm's range to ensure no anticipatory postural adjustments of the trunk.
16024248|NCT02708875|Other|Mixed Meal Challenge|Liquid mixed meal (300 calories - fat, carbohydrate, and protein).
16024249|NCT02708875|Other|Glucose Challenge|Glucose drink (50g glucose)
16024250|NCT02708862|Device|Preoxygenation|After 3 minutes of oxygen supplementation (preoxygenation), with each of the devices listed below, the exhaled oxygen content will be measured. All participants were enrolled in a single arm in which they underwent 4 interventions in series: 1) Simple mask at 60 L/min for 3 minutes 2) Non-rebreather at 60 L/min for 3 min 3) Non-rebreather at 15 L/min for 3 minutes 4) Bag valve mask at 15 L/min for 3 minutes
16024251|NCT02708849|Drug|Ketamine|The subanesthetic dose of ketamine (0.23mg/kg bolus followed by 0.58mg/kg infusion over approximately 60 minutes) will be administered via intravenous infusion
16024252|NCT02708849|Drug|Lamotrigine|lamotrigine (300 mg oral dose) or the matched-placebo control about 2-hours prior to the start of the infusion of ketamine
16024253|NCT02708849|Drug|Placebo|oral dose placebo
16024254|NCT02708836|Procedure|Induction of anesthesia|At the discretion of the primary anesthesiologist. Typically involves the administration of an analgesic agent, hypnotic agent, and neuromuscular blocking agent
16024255|NCT02708836|Device|Placement of LMA [Ambu (R) AuraGain (TM) disposable laryngeal mask]|By standard method. Sizing at the discretion of the primary anesthesiologist.
16024256|NCT02708836|Device|Laryngoscopy and placement of ETT|Via direct or indirect laryngoscopy. Sizing at the discretion of the primary anesthesiologist. Mallinckrodt (TM) Intermediate Hi-Lo cuffed endotracheal tube (Covidien)
16024257|NCT02708836|Procedure|Ventilation via the ETT|Ventilator mode, tidal volume/ ventilation pressure, respiratory rate, positive end expiratory pressure, inspired to expired ratio at the discretion of the primary anesthesiologist.
16024258|NCT02708836|Procedure|Removal of the ETT|Either upon emergence of anesthesia after suctioning of the oropharynx and after a positive pressure breath or while deeply anesthetized after release of the pneumoperitoneum in the combined LMA/ETT group.
16024259|NCT02708836|Procedure|Intubation of the trachea through the LMA|With ETT using fiberoptic bronchoscope guidance.
16024260|NCT02708836|Procedure|Ventilation via the LMA|After removal of the ETT. Ventilator mode, tidal volume/ ventilation pressure, respiratory rate, positive end expiratory pressure, inspired to expired ratio at the discretion of the primary anesthesiologist.
16024261|NCT02708836|Procedure|Emergence from anesthesia|"At the discretion of primary team. Airway device (either ETT or LMA) will be removed when patient is adequately ventilating and able to respond to commands (such as open your eyes or squeeze my hand)."
16024262|NCT02708823|Other|CogCheck application|The application is administered once to all study participants.
16024263|NCT02708810|Device|Unframed Virtual Cone|A face mask (unframed) will be placed over the patient's face to keep their head from moving during the procedure. This will allow for very precise targeting. During the procedure, the study doctor will also confirm the exact location that needs to be treated using x-rays and optical imaging cameras. The face mask (unframed) will hold the patient's head to prevent it from moving and to focus the x-rays and aim them on the painful nerve in the patient's brain. For most patients, the actual time on the radiosurgery treatment machine is in the range of 30 to 60 minutes. The face mask (unframed) will be removed after the treatment.
16024264|NCT02708810|Radiation|80 Gy Radiation|
16024265|NCT02708797|Other|Magnetic resonance imaging|Patients and controls will first be studied with MRI. The total duration of MRI is about 60mn. These technic is not invasive.
16024266|NCT02708797|Other|Transcranial Doppler|Patients and controls will first be studied with TCD. The total duration of TCD is about 60mn. These technic is not invasive.
16024267|NCT02708771|Drug|Polyunsaturated fatty acids omega-3|4 daily capsules of polyunsaturated fatty acids omega-3, during 4 weeks. Each capsule contains: 460 mg eicosapentaenoic acid ethyl ester and 380 mg docosahexaenoic acid ethyl ester.
16024268|NCT02708771|Drug|Placebo|4 daily capsules of similar appearance and flavor without active ingredient
16024428|NCT02707601|Drug|E/C/F/TAF|150/150/200/10 mg fixed dose combination (FDC) tablet administered orally once daily
16024269|NCT02708758|Behavioral|Medical Nutrition Therapy|individualized medical nutrition therapy from a qualified nutritionist which took into consideration a woman's pre-pregnancy weight, activity level, dietary intake and weight gain, instructions on how to self- monitoring capillary glucose levels two to four times daily until the levels had been in the recommended range (fasting glucose levels no more than 95 mg/dL and 1 hour postprandial less than 140 mg/dL). Drug therapy will begin with metformin or insulin when capillary glucose levels are not met the recommended levels after at least two weeks of treatment.
16024270|NCT02708745|Behavioral|Intervention Survey|
16024271|NCT02708745|Behavioral|Placebo Survey|
16024272|NCT02708719|Procedure|Pulmonary rehabilitation|Inpatient pulmonary rehabilitation has a duration of 3 weeks. This multimodal program consists of exercise training, breathing therapy, medical council, education and psychological support.
16024273|NCT02708706|Drug|hyaluronic acid (hyruan)|2cc hyaluronic acid
16024274|NCT02708706|Other|physical therapy|patient received traditional physical therapy, including therapeutic exercise and stretch exercise
16024275|NCT02708693|Drug|Triamcinolone Acetonide|ultrasound-guided injection using 1ml of 10 mg (10mg/ml) triamcinolone acetonide (Shincort)
16024276|NCT02708693|Device|thermoplastic wrist splint|thermoplastic wrist splint with wrist placed in a neutral position
16024277|NCT02708693|Drug|lidocaine hydrochloride|ultrasound-guided injection using 1 ml of 2% lidocaine hydrochloride (Xylocaine)
16024278|NCT02708680|Drug|entinostat|An orally available histone deacetylases inhibitor (HDAC)
16024279|NCT02708680|Drug|atezolizumab|A humanized, engineered monoclonal antibody of IgG1 isotype against the protein programmed cell death ligand 1 (PD-L1).
16024280|NCT02708680|Drug|Placebo|A pill containing no active drug ingredient
16024281|NCT02708654|Behavioral|Electronic pill bottle|Participant adherence to their diuretic will be monitored on a daily basis and participants will be contacted if they are non-adherence to this medication
16024282|NCT02708654|Behavioral|Bluetooth scale|Participant adherence to stepping on their scale will be monitored on a daily basis and participants will be contacted if they are non-adherent to weighing-in. Participant weight gain will also be monitored, and if weight gain exceeds a specific threshold, the managing physician will be notified through the electronic medical record system. Managing providers will also be sent a weekly report of weight measurements.
16024283|NCT02708654|Behavioral|Support Partner|Participants will identify a support partner who will be contacted if the participant is non-adherent to their diuretic and/or weighing-in.
16024284|NCT02708654|Behavioral|Engagement incentives|Participants will be entered into a daily lottery, for which their participation is contingent on adhering to their diuretic and to weighing-in on the previous day.
16024285|NCT02708641|Drug|pembrolizumab|200 mg IV given every three weeks
16024286|NCT02708628|Drug|extract of allium cepae, allantoin and heparin|prophylactic use of a topical gel containing extract of allium cepae, allantoin and heparin two times in a day after second c-section
16024287|NCT02708628|Procedure|Scar excision|Scar excision in second c-section
16024288|NCT02708615|Other|Type of speculum vaginal insertion method|Speculum insertion type will either be vertical rotation (as per common practice in Canada) or straight horizontal insertion
16024289|NCT02708602|Genetic|β2AR polymorphism|
16024290|NCT02708589|Dietary Supplement|probiotic|
16024291|NCT02708589|Other|Placebo|
16024292|NCT02708576|Biological|NGM313|
16024293|NCT02708576|Other|Placebo|
16024294|NCT02708563|Procedure|Immediate intubation|Infants that are not vigorous at delivery will receive immediate tracheal suctioning
16024295|NCT02708563|Procedure|Immediate resuscitation|Infants that are not vigorous at delivery will receive immediate initial steps of resuscitation and PPV if needed
16024296|NCT02708550|Behavioral|Participatory Organizational Intervention|
16024297|NCT02708537|Biological|PRGF in candidates for sperm donors|PRGF application on seminal aliquots will be conducted at different concentrations assessing sperm motility.
16024298|NCT02708524|Device|Senofilcon C Contact Lens|
16024299|NCT02708524|Device|Comfilcon A Contact Lens|
16024300|NCT02708524|Device|Lotrafilcon B Contact Lens|
16024301|NCT02708524|Device|Samfilcon A Contact Lens|
16024302|NCT02708511|Diagnostic Test|Computed Tomography|Undergo PET/CT
16024303|NCT02708511|Drug|Copper Cu 64-DOTA B-Fab|Given IV
16024304|NCT02708511|Other|Laboratory Biomarker Analysis|Correlative studies
16024305|NCT02708511|Other|Pharmacological Study|Correlative studies
16024306|NCT02708511|Diagnostic Test|Positron Emission Tomography|Undergo PET/CT
16024307|NCT02708498|Behavioral|Educational Intervention|The seminar groups will be led by two experienced clinical nurses and researchers from the field of palliative care and geriatric care. The educational material consist of six themes; values in palliative care, symptom relief, dignity and a dignified death, collaborative co-creating care, support to next of kin and dialogue with older persons and next of kin about death and dying. The content of the different themes will have a common core for each nursing home but will be adjusted based on the expressed needs of each nursing home. New themes can be created related to the needs of the unique nursing home. The participants in the seminar groups will reflect together over the content of the developed binder of educational material and will relate it to their own work in order to identify areas suitable for changes and/or development.
16024308|NCT02708485|Other|Physical exercise|A 3-month walking program (3 times a week for 12 weeks) on treadmill supervised by a physiotherapist. Duration of the exercise is progressively increased from 15 min to 45 min over a 6-week period and the intensity of the exercise is moderate (a 12-13 score on Borg scale).
16024309|NCT02708472|Device|synchronized Transcranial Magnetic Stimulation (sTMS)|"Subjects who qualify will receive daily active sTMS treatments with the NeoSync, Inc sTMS device. The device includes an EEG recording module and the device uses a proprietary algorithm to determine the individualized alpha frequency (IAF). The IAF obtained during this baseline recording is used throughout the study.
~The device contains three magnets in the sagittal line above the subject's scalp, which rotate along a transverse axis. sTMS stimulation is delivered broadly over the prefrontal and frontal regions of the brain. These magnets rotate to generate a sinusoidal magnetic field set at precisely the average individualized alpha frequency (IAF). Each therapy session lasts 30 minutes."
16024429|NCT02707601|Drug|F/R/TAF|200/25/25 mg FDC tablet administered orally once daily
16024310|NCT02708459|Device|surgically inserted Transversus abdominus plane catheter|at end of surgery, a surgeon will insert catheter in Transversus abdominus plane (TAP) between internal oblique muscle and Transversus abdominus muscle
16024311|NCT02708459|Drug|Intravenous morphine|Boluses of intravenous morphine (2 mg) will be given to patients if Visual analogue scale (VAS) more than 3
16024312|NCT02708459|Drug|Bupevecaine|
16024313|NCT02708459|Drug|Dexmedetomedine|
16024314|NCT02708446|Drug|Mifepristone|200mg oral mifepristone to both study arms
16024315|NCT02708446|Drug|Buccal misoprostol|doses of buccal misoprostol every 3 hours beginning 24 hours after mifepristone
16024316|NCT02708446|Drug|Sublingual misoprostol|doses of sublingual misoprostol every 3 hours beginning 24 hours after mifepristone
16024317|NCT02708433|Drug|Lidocaine|Lidocaine
16024318|NCT02708420|Device|Glidescope|This standard GlideScope (GS) technique involves a midline laryngoscopy followed by insertion of a styletted endotracheal tube, once an adequate view of the vocal cords is achieved.
16024319|NCT02708420|Device|Macintosh Laryngoscope|This technique involves a laryngoscopy followed by insertion of a styletted endotracheal tube, once an adequate view of the vocal cords is achieved.
16024320|NCT02708407|Procedure|Peritoneal Dialysis|One week after insertion of a PD catheter the intervention group will received a single nightly exchange, using dialysis fluid containing icodextrin; a variable proportion of participants may require a second exchange as directed by the consultant nephrologist as part of routine care. The second exchange would use dialysis fluid containing glucose, not icodextrin. Support and training will be given to each participant by the PD specialist team.
16024321|NCT02708394|Drug|olanzapine|atypical antipsychotic
16024322|NCT02708394|Drug|placebo|placebo control
16024323|NCT02708381|Other|Screening|Screening for geriatric issues to be referred to the Moffitt Cancer Center Oncogeriatric Information Team (OGIT).
16024324|NCT02708368|Other|blood withdrawal|3 times
16024325|NCT02708355|Drug|Esomeprazole 20 mg|Esomeprazole 20 mg banded capsules (22.3 mg esomeprazole magnesium trihydrate)
16024326|NCT02708355|Drug|Placebo|Placebo capsules
16024327|NCT02708329|Procedure|T-provisional stenting|Standard endovascular T-provisional stenting technique
16024328|NCT02708329|Procedure|Mini-crush stenting|Standard endovascular Mini-crush stenting technique
16024329|NCT02708329|Procedure|CTO coronary angioplasty|A standard endovascular procedure is carried out under local anesthesia and under fluoroscopic control. Recanalisation of coronary artery CTO is performed by the hydrophilic coronary wire, using the most appropriate technique. Then balloon angioplasty of target lesion is provided. After the angiographic control coronary stent is implanted. After coronary wire removing control angiographic study is provided. Medical therapy includes aspirin(acid acetylsalicylic) 125 - 300 mg/d and plavix(clopidogrel) in dose 300-600 mg prescription before the procedure and heparin (heparin sodium) injection during the procedure(5000 U iv). After the procedure aspirin(acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and plavix(clopidogrel) in dose 75/d should be prescribed within 12 months.
16024330|NCT02708316|Genetic|sequencing faecal metagenome|sequencing faecal metagenome is not the intervention measure.It is the observational method for investigators to detect the component of faecal microorganism.
16024331|NCT02708303|Other|Mayo Clinic Foregut Surgery Report Card Questionnaire|"Patients will be asked to complete the Mayo Clinic Foregut Surgery Report Card Questionnaire at approximately 8-10 weeks following surgery and then with each surveillance clinic visit or a minimum of once per year for their lifetime. The questionnaire can be completed at their clinic visit, over the telephone, or by mail. The patient's medical record will also be reviewed to gather any other contributing information.
~Data collected from the questionnaire will be entered into a database that will be maintained for future research."
16024332|NCT02708290|Other|MITA Prefrontal Synthesis exercises - each activity adapts to deliver the exercise that is at the exact level of difficulty appropriate for a child at any given point in time|"Mental Imagery Therapy for Autism (MITA) is an early-intervention application for children with Autism Spectrum Disorder (ASD). MITA app uses adaptive-learning technologies, with fun, educational exercises that adapt to a child's abilities, resulting in a highly-customized learning experience. The MITA application is available for free in the Apple Store, Google Play, and Amazon App Store.
~MITA verbal activities start with simple vocabulary-building exercises and progress toward exercises aimed at higher forms of language, such as noun-adjective combinations, spatial prepositions, recursion, and syntax. All exercises are deliberately limited to as few nouns as possible since the aim is not to expand a child's one-word vocabulary, but rather to teach him/her to integrate mental objects in novel ways by utilizing prefrontal synthesis (PFS). MITA activities outside of the verbal domain aim to provide the same PFS training visually through implicit instructions."
16024333|NCT02708277|Device|loop-shaped intrauterine contraceptive device|Intrauterine contraceptive device can temporary protective layer between the endometrium wound during the most critical three weeks after the surgery to prevent adhesion reformation.
16024334|NCT02708277|Device|intrauterine balloon (Cook Medical)|The balloons used in this study is heart- shaped that resembled the shape of the uterine cavity and could fully separate the two sides of the uterine wall and the corners of the uterus compare to loop-shaped intrauterine contraceptive device.
16024335|NCT02708264|Device|Cervical pessary|The cervical pessary is a silicone device that has been used to prevent SPTB
16024336|NCT02708251|Drug|glyceryl trinitrate cream|
16024337|NCT02708251|Drug|lidocaine cream|
16024338|NCT02708251|Drug|placebo cream|
16024339|NCT02708238|Dietary Supplement|Standardized extract of Chamomilla L., Melissa Officinalis L. and tyndallized L. Acidophilus (H122)|
16024340|NCT02708238|Dietary Supplement|Lactobacillus reuteri DSM 17938 (108 CFU)|
16024341|NCT02708238|Drug|Simethicone|
16024342|NCT02708225|Behavioral|medical clown|a medical clown will assist the child during the performance of pulmonary function test
16024343|NCT02708212|Procedure|EGD and colonoscopy|Cold forceps biopsy, cold snare polypectomy, and/or hot snare polypectomy will be performed for stomach and/or colon polyps during EGD and colonoscopy examinations will be performed whenever indicated.
16024344|NCT02708186|Drug|Nelotanserin|once daily, oral, 20-mg tablets
16024345|NCT02708186|Drug|Placebo|once daily, oral, matching tablets
16024346|NCT02708173|Biological|One dose of Quadrivalent Influenza Virus Vaccine|
16115041|NCT02050360|Drug|Placebo|
16024348|NCT02708160|Drug|Fluoride Free toothpaste|Brush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait 1 minute before rinsing with water.
16024349|NCT02708160|Drug|1.1% Fluoride toothpaste|Brush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait 1 minute before rinsing with water.
16024350|NCT02708160|Drug|0.243% Fluoride toothpaste|Brush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait 1 minute before rinsing with water.
16024351|NCT02708147|Other|Physiotheraphy + Conventional treatment|The experimental group will receive 5 physiotherapy sessions at home or in a physical therapy office. The respiratory techniques follow a flowchart which begins with saline instillation into the nose and nasopharyngeal cleaning techniques. Then to clear the lung slow inspiratory and slow and forced expiratory techniques will be used. The application of vibration is also included on the flowchart. During the sessions, educational information will also be provided.
16024352|NCT02708147|Other|Conventional treatment|Medication and observation by a physician/paediatrician. Only evaluations will be made at baseline and on the 3th, 5th and 21st days and an interview 30 days after.
16024353|NCT02708121|Behavioral|Motivational Intervention|Participants complete web-based assessment and receive tailored feedback to motivate weight loss treatment initiation and informed that they have access to weight loss treatment.
16024354|NCT02708121|Other|Comparator Intervention|Participants informed that they have access to weight loss treatment.
16024355|NCT02708108|Behavioral|Dietary Intervention|Beginning at time of diagnosis, the dietary component of the intervention uses a personalized menu to implement high protein, moderate fat, and low glycemic index/high fiber diet to achieve a minimum net -10% daily caloric deficit during the induction phase of chemotherapy.
16024356|NCT02708108|Behavioral|Activity and Exercise Intervention|"Beginning at the time of diagnosis, the exercise and activity component uses an activity menu to implement a target level of 200 minutes per week of moderate exercise activity (as estimated by metabolic equivalents) during the induction phase of chemotherapy."
16024357|NCT02708095|Drug|Baricitinib|Administered orally
16024358|NCT02708095|Drug|Placebo|Administered orally
16024359|NCT02708082|Device|OCT scanning and HFA perimetry|Imaging of the optic nerve and nerve fiber layer / measurement of visual field
16024360|NCT02708069|Other|e-Unstuck|An e-learning software that delivers the evidence-based Executive Functioning intervention to parents of children with Autism Spectrum Disorder without Intellectual Disability (ASDwoID) with personalized training and feedback on the evidence-based Unstuck and On Target (UOT) curriculum. Through video modeling, intelligent games, adaptive interactive exercises, and personalized feedback, e-Unstuck will provide parents with new tools for applying UOT principles to real world settings, above and beyond learning UOT principles.
16024361|NCT02708069|Other|Unstuck and On Target|An executive functioning intervention specifically targeted to the needs of the Autism Spectrum Disorder without Intellectual Disability (ASDwoID) population.
16024362|NCT02708056|Drug|Sugammadex|
16024363|NCT02708043|Other|Flexible-Laryngeal Mask Airway|
16024364|NCT02708030|Other|Ketogenic Diet|The children with the drug resistant epilepsy will go through a run in period of 4 weeks during which each child will undergo a detailed detailed clinical evaluation according to a structured proforma, and baseline investigations. The patients in KD arm will be admitted to the hospital for initiation of diet.
16024365|NCT02708030|Other|MAD|The children with the drug resistant epilepsy will go through a run in period of 4 weeks during which each child will undergo a detailed detailed clinical evaluation according to a structured proforma, and baseline investigations. Following the run in period of 4 weeks, the patients will be randomized to the MAD or LGIT or KD arm. MAD will be initiated on out patient basis.
16024366|NCT02708030|Other|LGIT|The children with the drug resistant epilepsy will go through a run in period of 4 weeks during which each child will undergo a detailed detailed clinical evaluation according to a structured proforma, and baseline investigations. Following the run in period of 4 weeks, the patients will be randomized to the MAD or LGIT or KD arm. LGIT will be initiated on out patient basis.
16024367|NCT02708017|Procedure|Ultrasound guided bilateral subcostal TAP block|ultrasound guided bilateral subcostal TAP block was performed after induction of general anaesthesia.after all aseptic measures,abdomen was prepared with antiseptic spray,with the help of portable ultrasound machine using probe frequency of 11 Mega Hertz,ultrasound probe was positioned parallel to the costal margin near the midline,the rectus abdominis muscle was identified ,probe was gradually moved laterally and obliquely along the subcostal margin and the transversus abdominis muscle identified lying posterior to the rectus muscle.the 20Gauge,100millimeter long needle was introduced at the lateral edge of the rectus muscle ,from medial to lateral,in plane of the ultrasound beam.After confirmation of the plane with saline, 20ml of 0.375% solution of bupivacaine was injected on each side of the abdomen.
16024368|NCT02708017|Procedure|Ultrasound guided bilateral posterior TAP block|ultrasound guided bilateral posterior TAP block was performed after induction of general anaesthesia.after all aseptic measures,abdomen was prepared with antiseptic spray.with the help of portable ultrasound machine using probe frequency of 11Mega Hertz,ultrasound probe was positioned transversely to the abdominal wall in the midaxillary line between the iliac crest and coastal margin,and carefully moved posteriolaterally for optimal identification of plane.the 20G,100mm long needle was introduced anteriorly and in line with the probe,from medial to lateral,and advanced until it reached the fascial plane between the internal oblique and transversus abdominis muscle.upon reaching the plane ,20ml of 0.375% solution of bupivacaine was injected on each side of the abdomen.
16024369|NCT02708004|Drug|ACT-132577|Formulated in capsules in 2 different strengths; 2 capsules per day
16024370|NCT02708004|Other|Placebo|Matching active drug
16024371|NCT02707991|Behavioral|Nurse Case Management|Participants will receive one baseline nurse case management study visit in addition to appointment reminders one week and one day before the scheduled hepatitis clinic appointment. Those who link to the Viral Hepatitis Clinic and are identified as eligible to start hepatitis C therapy by their health care provider will have one additional study visit with the nurse case manager to coordinate drug-drug interaction prevention.
16024430|NCT02707601|Drug|LDV/SOF|90/400 mg FDC tablet administered orally once daily
16024372|NCT02707978|Drug|F 18 T807|Participants will receive a single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807. For those who cannot tolerate the full exam, participants will receive single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807.
16024373|NCT02707965|Drug|Oxcarbazepine (brand name vs generic drugs)|This is a cross-over replicate study with 2 sequences (arms) comparing brand name and generic anti-epileptic drugs. Subjects will take a brand name and a generic drug of the same intervention. While there are only 2 sequences, there are 8 possible drugs for this study, and a study patient will only take 1 out of 8 study drugs. Only pharmacists will know which sequence each patient is assigned to.
16024374|NCT02707965|Drug|Divalproex Sodium (brand name vs generic drugs)|This is a cross-over replicate study with 2 sequences (arms) comparing brand name and generic anti-epileptic drugs. Subjects will take a brand name and a generic drug of the same intervention. While there are only 2 sequences, there are 8 possible drugs for this study, and a study patient will only take 1 out of 8 study drugs. Only pharmacists will know which sequence each patient is assigned to.
16024375|NCT02707965|Drug|Carbamazepine (brand name vs generic drugs)|This is a cross-over replicate study with 2 sequences (arms) comparing brand name and generic anti-epileptic drugs. Subjects will take a brand name and a generic drug of the same intervention. While there are only 2 sequences, there are 8 possible drugs for this study, and a study patient will only take 1 out of 8 study drugs. Only pharmacists will know which sequence each patient is assigned to.
16024376|NCT02707965|Drug|Lamotrigine (brand name vs generic drugs)|This is a cross-over replicate study with 2 sequences (arms) comparing brand name and generic anti-epileptic drugs. Subjects will take a brand name and a generic drug of the same intervention. While there are only 2 sequences, there are 8 possible drugs for this study, and a study patient will only take 1 out of 8 study drugs. Only pharmacists will know which sequence each patient is assigned to.
16024377|NCT02707965|Drug|levetiracetam (brand name vs generic drugs)|This is a cross-over replicate study with 2 sequences (arms) comparing brand name and generic anti-epileptic drugs. Subjects will take a brand name and a generic drug of the same intervention. While there are only 2 sequences, there are 8 possible drugs for this study, and a study patient will only take 1 out of 8 study drugs. Only pharmacists will know which sequence each patient is assigned to.
16024378|NCT02707965|Drug|Topiramate (brand name vs generic drugs)|This is a cross-over replicate study with 2 sequences (arms) comparing brand name and generic anti-epileptic drugs. Subjects will take a brand name and a generic drug of the same intervention. While there are only 2 sequences, there are 8 possible drugs for this study, and a study patient will only take 1 out of 8 study drugs. Only pharmacists will know which sequence each patient is assigned to.
16024379|NCT02707965|Drug|Zonisamide (brand name vs generic drugs)|This is a cross-over replicate study with 2 sequences (arms) comparing brand name and generic anti-epileptic drugs. Subjects will take a brand name and a generic drug of the same intervention. While there are only 2 sequences, there are 8 possible drugs for this study, and a study patient will only take 1 out of 8 study drugs. Only pharmacists will know which sequence each patient is assigned to.
16024380|NCT02707965|Drug|Phenytoin sodium (brand name vs generic drugs)|This is a cross-over replicate study with 2 sequences (arms) comparing brand name and generic anti-epileptic drugs. Subjects will take a brand name and a generic drug of the same intervention. While there are only 2 sequences, there are 8 possible drugs for this study, and a study patient will only take 1 out of 8 study drugs. Only pharmacists will know which sequence each patient is assigned to.
16024381|NCT02707952|Drug|ABT-493/ABT-530|Co-formulated tablet
16024382|NCT02707952|Drug|OBV/PTV/r|Co-formulated tablet
16024383|NCT02707939|Other|Observation|Patients will be observed before and after they receive anesthesia
16024384|NCT02707926|Drug|Anti-HIV Agents|Therapy to treat HIV infection
16024385|NCT02707913|Drug|BF-Amlodipine Tablet 10mg|BF-Amlodipine Tablet 10mg is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
16024386|NCT02707913|Drug|Norvasc Tablet 10mg|Norvasc Tablet 10mg will be used as a comparator drug for the BE study
16024387|NCT02707900|Drug|Vorinostat|"At Step 2 (Enrollment) - subjects receive two paired oral doses of Vorinostat (VOR) 400 mg.
~Step 5 - Approximately 7- 10 days after the 4th dose of AGS-004 in Step 4 (Visit 11), ten (10) doses of VOR 400 mg will be administered at 72 hour intervals.
~Steps 6 - 7 & EOS visit - Repeat cycles of AGS-004 and VOR. Participants will undergo a second series of 4 AGS-004 vaccinations (Step 6) followed by 10 doses of VOR 400 mg PO (Step 7)."
16024388|NCT02707900|Biological|AGS-004|"Step 4 - AGS-004 vaccination. AGS-004 product will be delivered in three intradermal injections of 0.2 mL (0.6 mL total volume) for a total of 1.2 x 10-7 viable cells. AGS-004 will be administered every 3 weeks for 4 doses.
~Steps 6 - 7 & EOS visit - Repeat cycles of AGS-004 and VOR. Participants will undergo a second series of 4 AGS-004 vaccinations (Step 6) followed by 10 doses of VOR 400 mg PO (Step 7)."
16024389|NCT02707887|Behavioral|LETS ACT|The Life Enhancement Treatment for Substance Use (LETS ACT)
16024390|NCT02707887|Behavioral|LETS ACT-SE|Participants assigned to the smartphone-enhanced LETS ACT (LETS ACT-SE) condition will be provided the exact same treatment as outlined in LETS ACT, except that LETS ACT-SE participants will record their daily goals using smartphone technology.
16024391|NCT02707887|Behavioral|Treatment as Usual|Participants will receive the treatment typically provided to patients at the substance use treatment facility.
16024392|NCT02707874|Drug|CI 0.2% ropivacaine|Patients in Group CI will receive continuous infusion of 0.2% ropivacaine at 5 mL/hour; total 4-hourly consumption = 20 mL = 40 mg ropivacaine. All patients will be able to self-administer PCA boluses of 5 mL of ropivacaine 0.2% at intervals of 30 minutes as required
16024393|NCT02707874|Drug|PIB 0.2% ropivacaine|Patients in Group Programmed intermittent bolus (PIB) will receive automated programmed intermittent boluses of 10 mL of ropivacaine 0.2% every 2 hours; total 4-hourly consumption = 20 mL = 40 mg ropivacaine. All patients will be able to self-administer PCA boluses of 5 mL of ropivacaine 0.2% at intervals of 30 minutes as required
16024394|NCT02707861|Drug|ibalizumab|Intravenous infusion of humanized monoclonal antibody binding with a region of Domain 2 of CD4 receptor, blocking post-attachment conformational changes necessary for HIV cell entry
16024431|NCT02707588|Drug|Pembrolizumab|"200mg IV infusion every 3 weeks, i.e. on day 1, 22, 43 during the course of radiotherapy.
~Radiotherapy will be delivered daily for 5 days per week to a total dose of 69.96 Gy in 2.12 Gy daily fractions over 6.5 weeks (33 fractions)."
16026151|NCT02695420|Drug|37.5 mg Omecamtiv Mecarbil|oral tablet
16024395|NCT02707861|Drug|Optimized Background Regimen|An investigator-selected, standard-of-care combination regimen of antiretroviral agents for treating HIV-1 infection, selected based upon patient treatment history and the results of previous viral resistance testing. The combination must contain at least one agent other than ibalizumab to which the patient's virus is sensitive (susceptible).
16024396|NCT02707848|Other|No intervention|
16024397|NCT02707835|Other|self massage|self massage, skin care education, manual lymph drainage exercise, compression garment
16024398|NCT02707835|Other|manual lymph drainage|manual lymph drainage by a physical therapist, skin care education, manual lymph drainage exercise, compression garment
16024399|NCT02707835|Other|epidermis fascia taping|epidermis fascia taping by a physical therapist, skin care education, manual lymph drainage exercise, compression garment
16024400|NCT02707822|Other|Clinical and genetic factors|
16024401|NCT02707809|Drug|Dexmedetomidine|Dexmedetomidine infusion
16024402|NCT02707796|Procedure|Hemicolectomy|
16024403|NCT02707783|Device|Bioresorbable vascular scaffold (BVS) implantation|
16024404|NCT02707770|Other|Pulmonary Rehabilitation|
16024405|NCT02707757|Drug|Iron sucrose|1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl
16024406|NCT02707757|Drug|Erythopoietin stimulating agent|Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria
16024407|NCT02707744|Other|no intervention|
16024408|NCT02707731|Procedure|Hydrokinesiotherapy|physical therapy technique used in a plastic bucket approved by ANVISA , with water temperature monitored at 37 ° C, water level up to the shoulders and by the physical properties of water, was allowed to mobilize the newborn facilitating the feeling of relaxation and standard suitable movement.
16024409|NCT02707718|Biological|blood sampling|during the usual blood sampling performed in the ED in patients suspected of sepsis, two additional tubes will be sampled for a panel of biomarkers measurement
16024410|NCT02707705|Device|Apply an auricular acupuncture protocol by stimulating specific points of the ear with needles inserted on adhesive tape (Pyonex®).|"Intervention Description :
~The auricular acupuncture protocol is based on an anxiolytic triad of three points selected according to the World Health Organization classification. These points are detected and located precisely by a differential detector starting with the right ear, and in the absence of response, the points are searched on the left ear. The detected points are treated by application of adhesive tape with needles of diameter 0.2 mm and length 0.9 mm.
~Data collected :
~T0 : anxiety VAS, pain VAS, APAIS, ANI, arterial pressure and cardiac frequency
~T1 : anxiety VAS, pain VAS, APAIS, ANI, arterial pressure, cardiac frequency and side effects
~T2 : anxiety VAS, pain VAS, arterial pressure, cardiac frequency and side effects
~T3 : anxiety VAS, pain VAS, arterial pressure, cardiac frequency and side effects"
16024411|NCT02707705|Device|Apply a device having no real effect|"The three points of the protocol are detected and located precisely by a differential detector starting with the right ear, and in the absence of response, the points are searched on the left ear.The detected points are treated by application of adhesive tape without needle.
~Data collected :
~T0 : anxiety VAS, pain VAS, APAIS, ANI, arterial pressure and cardiac frequency
~T1 : anxiety VAS, pain VAS, APAIS, ANI, arterial pressure, cardiac frequency and side effects
~T2 : anxiety VAS, pain VAS, arterial pressure, cardiac frequency and side effects
~T3 : anxiety VAS, pain VAS, arterial pressure, cardiac frequency and side effects"
16024412|NCT02707705|Procedure|Disinfection|The ear is disinfected by applying Chlorhexidine®.
16024413|NCT02707692|Biological|Fluarix|Intramuscular injection with Fluarix® .
16024414|NCT02707692|Biological|Pneumovax|Intramuscular injection with Pneumovax.
16024415|NCT02707692|Other|Placebo|Intramuscular injection with sterile saline (placebo).
16024416|NCT02707679|Other|Mulligan's Straight leg-raise with traction|Mulligan's Straight leg raise technique was performed on patients with patellofemoral pain syndrome. The extremity on which the practice would be performed in supine position was grasped from the ankle level and was, then, subjected to traction longitudinally. Afterwards, the knee was lifted up passively while in extension and was kept for waiting for a few seconds at the point where tension was felt and was, then, returned to its initial position. The practice was repeated 10 times, and 3 sets of practice at 1-minute-intervals were performed.
16024417|NCT02707679|Other|Mulligan's Mobilization with Movement|Mulligan's Mobilization with Movement technique was performed on patients with patellofemoral pain syndrome. Each patient was tested in every direction in the course of the active knee flexion-extension movement so as to find out the best pain-free tibial gliding direction (medial-lateral part of the tibia, anterior-posterior, internal-external rotation). At the time of the active movement of the knee, the tibial gliding direction where pain was felt at the least was selected as the treatment direction of mobilization technique along with movement. The practice was performed by doing 10 repetitions for 3 sets and by providing 1-minute-resting time between the sets.
16024418|NCT02707679|Other|Kinesiotaping|Kinesiotaping was applied on patient with patellofemoral pain syndrome. To maintain proprioceptive stimulation in the quadriceps (from origo towards insertio) and to alleviate the tension of hamstring muscle, a 'Y''-shaped kinesiotape was applied by using the muscle technique.
16024419|NCT02707679|Other|Exercise|All the patients were provided with several exercises within the scope of the home exercise program, such as hamstring muscle stretching, quadriceps isometric exercises, 4-way-strengthening with exercise elastic bands for the muscles of the hip, knee locking on foot and mini-squatting exercises. They were asked to do these exercises in 3 sets a day along with 10 repetitions for a period of 6 weeks.
16024420|NCT02707666|Drug|Pembrolizumab|Neoadjuvant pembrolizumab every 21 days for three cycles
16024421|NCT02707666|Drug|Cisplatin and Pemetrexed|Adjuvant chemotherapy with cisplatin and pemetrexed every 21 days for 4 cycles
16024422|NCT02707653|Drug|Misoprostol|400 mcg sublingual misoprostol
16024423|NCT02707640|Drug|Matching Placebo|Matching Placebo, oral administration, three times daily for 24 weeks.
16024424|NCT02707640|Drug|N-acetylcysteine|N-acetylcysteine, 600 mg, oral administration, three times daily for 24 weeks.
16024425|NCT02707640|Drug|Pirfenidone|Pirfenidone, at least 1602 mg/day, oral administration, for 32 weeks, during the wash-out and screening period and for at least 8 weeks prior to randomization.
16024426|NCT02707627|Device|Laser Therapy|Laser therapy is a technology that can be used to treat hypertrophic burn scars.
16024427|NCT02707614|Procedure|Robotic vs open prostastectomy|robotic minimal invasive surgery
16024432|NCT02707588|Drug|Cetuximab|"Loading dose of 400 mg/m² IV on Day-8, followed by weekly dose of 250 mg/m² IV during the whole course of radiotherapy.
~Radiotherapy will be delivered daily for 5 days per week to a total dose of 69.96 Gy in 2.12 Gy daily fractions over 6.5 weeks (33 fractions)."
16024433|NCT02707588|Radiation|Radiotherapy|Radiotherapy will be delivered daily for 5 days per week to a total dose of 69.96 Gy in 2.12 Gy daily fractions over 6.5 weeks (33 fractions).
16024434|NCT02707575|Drug|Ranibizumab|Three monthly consecutive injections of 0.5-mg ranibizumab will be performed. Aqueous humor samples will be taken each time an intravitreal injection in indicated and performed.
16024435|NCT02707562|Drug|GLPG1837 dose 1|two GLPG1837 tablets in the morning and two GLPG1837 tablets in the evening, for one week
16024436|NCT02707562|Drug|GLPG1837 dose 2|two GLPG1837 tablets in the morning and two GLPG1837 tablets in the evening, for one week
16024437|NCT02707562|Drug|GLPG1837 dose 3|two GLPG1837 tablets in the morning and two GLPG1837 tablets in the evening, for two weeks
16024438|NCT02707549|Drug|balanced crystalloid solution (components: sodium chloride, sodium gluconate, sodium acetate, potassium chloride and magnesium chloride)|
16024439|NCT02707549|Drug|0.9% sodium chloride|
16024440|NCT02707536|Procedure|Socket grafting with PRF|Extraction with socket grafting using PRF.
16024441|NCT02707536|Procedure|Socket grafting with bone graft|Extraction with socket grafting using bone graft.
16024442|NCT02707523|Drug|Azithromycin 10 mg|
16024443|NCT02707523|Drug|Azithromycin 20mg|
16024444|NCT02707523|Drug|Placebo|
16024445|NCT02707510|Other|Growing Resiliency And CouragE with Cancer™ (GRACE)|GRACE is a 6 week curriculum which includes themes illustrated via PowerPoint slides with semi-structured delivery, video presentations, a variety of mindfulness meditation practices, and selected readings that serve to reflect and capture the theme for the week of the curriculum.
16024446|NCT02707497|Drug|rhTPO|Recombinant Human Thrombopoietin，TPIAO®, Shenyang Sunshine Pharmaceutical Company Limited [SUNSHINE], Shenyang, China）， 15000u/d, qd, subcutaneous injection, daily for no more than 7 consecutive days
16024447|NCT02707497|Drug|Placebo|The control group will not use any platelet-increased drugs.
16024448|NCT02707484|Drug|Thalidomide (100mg)|Patients were randomly assigned to receive a four-month course of 100 mg of thalidomide (Pharmaceutical Co., Ltd. of ChangZhou, China).
16024449|NCT02707484|Drug|Thalidomide (50mg)|Patients were randomly assigned to receive a four-month course of 50 mg of thalidomide (Pharmaceutical Co., Ltd. of ChangZhou, China).
16024450|NCT02707484|Drug|placebo|Patients were randomly assigned to receive a four-month course of placebo (Pharmaceutical Co., Ltd. of ChangZhou, China).
16024451|NCT02707471|Behavioral|SM-AET|self-management for improving adherence and reducing symptom interference (SM-AET)
16024452|NCT02707471|Behavioral|general health education|general health education intervention that focuses on improving overall health.
16024453|NCT02707458|Drug|Probucol|"Probucol was used with good effect for more than a decade in Canada and the US to reduce plasma cholesterol. Although withdrawn from the Canadian and US markets by its manufacturer for commercial reasons, it is still widely used for this purpose in Japan and Korea. Over the past decade, long-term follow-up studies in Asian populations at high risk of cardiovascular events have shown that the drug reduces the incidence of these events in a manner not unlike statin drugs used widely in Canada and the US."
16024454|NCT02707445|Drug|Clopidogrel|Administration of conventional dual anti-platelet treatment (aspirin 100mg and clopidogrel 75mg daily) for minimum 3 months after percutaneous coronary intervention
16024455|NCT02707432|Behavioral|Heart Matters|"Heart Matters is an intervention adapted from PREMIER, an evidence-based, comprehensive lifestyle intervention that focuses on blood pressure as the primary outcome. To assess the feasibility and efficacy of adapting PREMIER for rural African Americans, Heart Matters will be delivered to multiple intervention groups, but at two different stages."
16024456|NCT02707419|Device|Experimental group|Video of the exercises
16024457|NCT02707419|Device|Control group|video of nature scenes
16024458|NCT02707419|Device|Conventional physiotherapy|Mobilization, exercises and transfer practice.
16024459|NCT02707406|Other|NEOX®CORD 1K|use of human tissue product wound covering
16024460|NCT02707406|Other|standard of care|standard wound coverings
16024461|NCT02707393|Drug|Fludarabine|infusion
16024462|NCT02707393|Drug|Thiotepa|infusion
16024463|NCT02707393|Drug|Melphalan|infusion
16024464|NCT02707393|Drug|ATG|infusion
16024465|NCT02707393|Drug|Cyclosporine A|infusion, orally if possible
16024466|NCT02707393|Drug|Mycophenolate mofetil|infusion
16024467|NCT02707393|Biological|bone marrow or peripheral blood stem cells|infusion
16024468|NCT02707380|Other|Resistance Training|7 muscle-strengthening exercises using body weight resistance and elastic resistance bands
16024469|NCT02707380|Other|Standard of Care|3 exercises that do not include these 7 muscle-strengthening exercises
16024470|NCT02707367|Behavioral|Recovery Roadmap (RR) Wave 1|"A web-based tool that provides guidance for implementing Person-Centered Recovery Planning. There are 3 components:
~Online module for service providers: A self-paced online module with interactive exercises, audio/video case studies, self-assessment, handouts, and collaborative materials designed for use with clients.
~Online module for people in recovery: A self-paced online module with interactive exercises, case studies, self-assessment, informational handouts, and collaborative materials to be completed with providers.
~Coaching & Support Center: A multimedia resource for providers with online coaching, a community of practice, and a resource library."
16024471|NCT02707367|Behavioral|Recovery Roadmap (RR) Wave 2|"A web-based tool that provides guidance for implementing Person-Centered Recovery Planning. There are 3 components:
~Online module for service providers: A self-paced online module with interactive exercises, audio/video case studies, self-assessment, handouts, and collaborative materials designed for use with clients.
~Online module for people in recovery: A self-paced online module with interactive exercises, case studies, self-assessment, informational handouts, and collaborative materials to be completed with providers.
~Coaching & Support Center: A multimedia resource for providers with online coaching, a community of practice, and a resource library."
16024512|NCT02707081|Drug|Intravenous Lidocaine|Patients received 1.5mg/kg of intravenous 1% lidocaine as bolus dose at induction and 2mg/kg/hour as continuous infusion of intravenous lidocaine until one hour after surgery.
16024472|NCT02707354|Device|Probe based confocal laser endomicroscopy (Cellvizio)|"The probe is a miniaturized microscope in the form of a fiber which is inserted through the endoscope and brought into contact with the mucosa. It thus allows for a live virtual biopsy, that is to say, obtaining real-time microscopic virtual image of the mucosa. It requires an intra-veinous injection of 5 mL of 10% fluorescein diluted in 50 cc of saline serum. The images obtained during the examination will be recorded via the endomicroscopy console so that two endoscopists blinded from the macroscopic and histological findings can review the data."
16024473|NCT02707328|Drug|Gemcitabine|
16024474|NCT02707328|Drug|nab-paclitaxel|
16024475|NCT02707328|Radiation|CyberKnife|
16024476|NCT02707315|Drug|Gemcitabine|
16024477|NCT02707315|Radiation|Stereotactic Radiosurgery|
16024478|NCT02707302|Device|Iodophor-impregnated adhesive drapes group|Odd-numbered patients are randomized to the iodophor-impregnated adhesive drapes group.3M™ loban™2 iodophor-impregnated adhesive drape(3M Company, St. Paul, Minnesota, USA) will be used at the surgical site in the iodophor-impregnated adhesive drapes group.
16024479|NCT02707302|Procedure|Iodophor-free adhesive drapes group|Even-numbered patients are randomized to the iodophor-free adhesive drapes group. Iodophor-free aseptic adhesive drapes(3M Company, St. Paul, Minnesota, USA) will be used at the surgical site in the iodophor-free adhesive drapes group.
16024480|NCT02707276|Device|Active Low Field Magnetic Stimulation|Low Field Magnetic Stimulation is an electromagnetic treatment being investigated for its effects on mood. It uses magnetic fields that are a fraction of the strength but at a higher frequency than the electromagnetic fields used in transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT)
16024481|NCT02707276|Device|Sham Low Field Magnetic Stimulation|The sham treatment does not provide any electromagnetic stimulation. However, it is designed so that it cannot be differentiated from the active treatment.
16024482|NCT02707263|Drug|intravenous continuous infusion of heparin (IV UFH)|
16024483|NCT02707263|Drug|Subcutaneous Heparin|
16024484|NCT02707250|Drug|Placebo|Tap Block performed with normal sterile saline 20 ml on the right side and 20 ml on the left side
16024485|NCT02707250|Drug|Bupivacaine|Tap Block performed with Bupivacaine 0,25% 20 ml on the right side and 20 ml on the left side.
16024486|NCT02707250|Drug|Pethidine|Tap Block performed with pethidine 1% 10 ml on the right side and 10 ml on the left side
16024487|NCT02707250|Drug|Pethidine Local Infiltration (L.I)|Local infiltration of port sites (trocar insertion sites) with pethidine 1% 5ml each port (trocar site) ,4 ports total 20 ml pethidine 1%
16024488|NCT02707237|Other|Verbal counseling|Verbal counseling done by physician
16024489|NCT02707237|Other|Verbal, pictorial, written counseling|verbal counseling in addition to gestational age specific written information and pictures will be given to parents
16024490|NCT02707224|Drug|DP-R208|Investigational product is prescribed to all of randomized subjects
16024491|NCT02707224|Drug|Candesartan cilexetil|Investigational product is prescribed to all of randomized subjects
16024492|NCT02707224|Drug|Rosuvastatin|Investigational product is prescribed to all of randomized subjects
16024493|NCT02707211|Biological|Anti-oxLDL IgM antibody|Immunization
16024494|NCT02707198|Drug|kefir|4 ounces of kefir 3 times a day, with or without food.
16024495|NCT02707185|Behavioral|Simulation-Based Training|An objective assessment tool has been developed and tested in medical code scenarios during training sessions recently done in the simulation lab. The tool has five domains: Airway, Breathing, Circulation, Communications/Leadership, and Defibrillation. Each domain consists of 3-8 tasks and skills.
16024496|NCT02707172|Behavioral|handwashing with soap|handwashing with soap by a standardized 6-step handwashing technique
16024497|NCT02707172|Behavioral|handwashing with water|handwashing with water by a standardized 6-step handwashing technique
16024498|NCT02707159|Drug|Nab paclitaxel / gemcitabine|Patients will receive gemcitabine/nab-paclitaxel combination chemotherapy
16024499|NCT02707146|Behavioral|Visit Planner|The Visit Planner is an application hosted on an iPad that guides the patient in preparing for the primary care visit
16024500|NCT02707146|Other|Attention Control Pamphlet|Patients in the attention control arm will receive an approved educational handout on health lifestyle
16024501|NCT02707146|Device|iPad|
16024502|NCT02707133|Other|No intervention|
16024503|NCT02707120|Drug|PRGF-Endoret|Active treatment will be PRP eye drops obtained by the PRGF-Endoret system.
16024504|NCT02707120|Drug|Artificial tears eye-drops|Artificial tear moisturizing eyedrops (Hidrathea®, Nacl 0.9 % solution without preservatives).
16024505|NCT02707107|Drug|Intravenous infusions of WCK 5222|
16024506|NCT02707107|Drug|Placebo|
16024507|NCT02707094|Device|Biomodulator|The Biomodulator is a type of very low frequency TENS known as pulsed electromagnetic field therapy (PEMF). Unlike TENS devices that deliver 1-80 milliamperes of electrical current, PEMF devices deliver short bursts of electrical microamperes (millionths of an ampere) to injured tissues without producing heat or interfering with nerve or muscle function. Micro-current levels between 20-500 microampere appear to be most effective at relieving pain and inflammation and promoting tissue healing by realigning the natural electrical balance that exists within the cells that has become disrupted due to injury.
16024508|NCT02707094|Other|Usual Care (Medication + Exercise)|The study LP will prescribe an analgesic medication regimen based on the participant's needs. These medications may consist of Non-steroidal anti-inflammatory Drugs (NSAIDs) (ibuprofen, naproxen sodium, etc.), muscle relaxants (Flexeril, Robaxin, valium, etc.), non-narcotic analgesic medications (acetaminophen, aspirin, tramadol, etc.), or narcotic medications (Tylenol #3, Percocet, Vicodin, etc.) depending on the severity of their pain and co-morbid conditions. The RC will also provide instructions for LBP stretching and strengthening exercises. The following exercises will be recommended as a daily regimen: the partial curl, cat and camel, pelvic tilt, quadriceps, arm/leg raises,trunk rotation, single knee to chest stretch, standing hamstring stretch, and double knee to chest stretch.
16024509|NCT02707081|Drug|Intravenous normal saline|Normal saline in a volume equivalent to that used in intravenous lidocaine group
16024510|NCT02707081|Drug|Intraperitoneal normal saline|Patients received 00 ml of saline intraperitoneally
16024511|NCT02707081|Drug|Intraperitoneal Lidocaine|Patients received 1.75 ml/kg of 0.2% lidocaine (3.5mg/kg) with parietal peritoneal closure.
16025429|NCT02700685|Other|Placebo|Placebo treatment (identical capsules containing excipients only)
16024513|NCT02707068|Behavioral|Quality Of LIfe Tool for IBD (QOLITI)|The cognitive-behavioural therapy (CBT)-inspired manual will contain several chapters each of which addresses a different topic with information, guidance in setting goals for behaviour change and accompanying tasks to aid implementation which will be completed at home in the participant's own time. Key themes are likely to include symptom management, dealing with social implications of the disease and interacting effectively with healthcare professionals among others. Each chapter will address a theme providing information, sign posting to appropriate organisations, step-by-step tasks and quotes from pwIBD among others, drawing on relevant therapeutic approaches for self-management including CBT and certain elements of Acceptance and Commitment Therapy.
16024514|NCT02707055|Drug|PF-05190457|Ghrelin Receptor Inverse Agonist
16024515|NCT02707055|Behavioral|MI-VF|Motivational Interviewing with Video
16024516|NCT02707055|Other|Placebo|Placebo
16024517|NCT02707055|Other|Counseling|Counselling Support
16024518|NCT02707055|Behavioral|Immersive Virtual Environment Test Unit|virtual reality context
16024519|NCT02707055|Diagnostic Test|Functional Magnetic Resonance Image|Imaging Scan
16024520|NCT02707042|Drug|Amoxicillin|7 day therapeutic oral course of twice daily amoxicillin
16024521|NCT02707042|Drug|Azithromycin|5 day oral course of once-daily azithromycin
16024522|NCT02707042|Other|Control|A group of volunteers will receive no antibiotics and will serve as study controls.
16024523|NCT02707016|Other|Sevoflurane 8%|Sevoflurane 8% (high dose) during anesthesia induction
16024524|NCT02707016|Other|Sevoflurane 5%|Sevoflurane 5% (low dose) during anesthesia induction
16024525|NCT02706990|Device|Physica KR|Kinematic retaining total knee implant
16024526|NCT02706990|Device|Physica PS|Posterior stabilized total knee implant
16024527|NCT02706977|Drug|Low Dose Sinemet CR|Sinemet CR (25 mg carbidopa/100 mg levodopa) will be taken by mouth twice daily for two weeks.
16024528|NCT02706977|Drug|High Dose Sinemet CR|Sinemet CR (50 mg carbidopa/200 mg levodopa) will be taken by mouth twice daily for two weeks.
16024529|NCT02706977|Device|RETeval Electroretinogram (ERG) Testing|ERG testing consists of sitting in the dark for 15 minutes. During the procedure, participants will have a single-use adhesive sensor strip placed on the skin near the eye. A hand-held device, called the RETeval, will be placed in front of the eye and a series of flashes and flickering lights presented. The light intensity level is typically not uncomfortable. When right eye imaging is complete, the procedure will be repeated on the left eye. Both eyes will be evaluated in less than 5 minutes for most participants. Electroretinogram (ERG) testing will be completed at baseline, day 1, week 2, and week 4.
16024530|NCT02706977|Other|Contrast Sensitivity Testing|Contrast sensitivity testing consists of looking at a series of moving lines on a tablet device. The lines will change from white to grey to black. Participants will be asked to determine when they can no longer distinguish between the lines. Contrast sensitivity testing will be completed at baseline, day 1, week 2, and week 4.
16024531|NCT02706977|Other|Visual Acuity Testing|Participants will be asked to look at an eye chart with letters or symbols that become smaller as they move from top to bottom of the chart. Visual acuity testing will be completed at baseline, day 1, week 2, and week 4.
16024532|NCT02706964|Device|Positron emission tomography/x-ray computed tomography|A whole-body PET/CT will be performed to identify the site and extent of spread.
16024533|NCT02706964|Device|Magnetic resonance imaging|A brain MRI will be performed.
16024534|NCT02706964|Device|x-ray computed tomography (CT)|A CT scan will be performed to identify the site and extent of spread.
16024535|NCT02706951|Drug|Methotrexate|Capsule; Oral
16024536|NCT02706951|Drug|Upadacitinib|Tablet; Oral
16024537|NCT02706951|Drug|Placebo Upadacitinib|Tablet; Oral
16024538|NCT02706951|Drug|Placebo Methotrexate|Capsule; Oral
16024539|NCT02706938|Other|Head of bed elevation|Head of bed elevation will be achieved with a pair of prisms of withered pine tree wood with dimensions (Height x Width x Depth) 20x18x18 cm. Each prism lying on the floor will support one of the head legs of the bed
16024540|NCT02706938|Other|Standard treatment|Standard pharmacological treatment with a proton pump inhibitor and/or sodium alginate, according to clinical judgement.
16024541|NCT02706925|Drug|BI 443651|
16024542|NCT02706925|Drug|Placebo|
16024543|NCT02706912|Behavioral|VOTA Therapy|During sessions of approximately one hour in duration, participants practice performing virtual activities of daily living (ADLs) using the VOTA system. During this practice, the participant's real-world motion is replicated by an avatar's motion in the virtual world. To complete the activities, participant's must perform a wide range of functional arm movements while interacting with virtual objects. Individuals are asked to perform three such one-hour virtual ADL practice sessions per week over a participation period of approximately eight weeks.
16024544|NCT02706899|Drug|vadastuximab talirine|Intravenous (IV) push every 4 weeks
16024545|NCT02706899|Drug|Azacitidine|75 mg/m^2 given intravenously or subcutaneously for 7 days every 4 weeks
16024546|NCT02706899|Drug|Placebo (for 33A)|Placebo supplied in single-use vials matching 33A, IV push every 4 weeks
16024547|NCT02706886|Drug|Lumasiran|Lumasiran will be administered SC once in Part A. In Part B lumasiran will be administered SC qM (Days 1, 29 and 57) or q3M (Days 1 and 85).
16024548|NCT02706886|Drug|Placebo|Matching placebo (sterile saline: 0.9% sodium chloride [NaCl]) will be administered SC once in Part A. In Part B matching placebo will be administered SC qM (Days 1, 29 and 57) or q3M (Days 1 and 85).
16024549|NCT02706873|Drug|Placebo to Upadacitinib|Tablet; Oral
16024550|NCT02706873|Drug|Methotrexate|Capsule or Tablet; Oral
16024551|NCT02706873|Drug|Placebo to Methotrexate|Capsule or Tablet; Oral
16024552|NCT02706873|Drug|Upadacitinib|Tablet; Oral
16024553|NCT02706860|Drug|Atorvastatin|
16024554|NCT02706847|Drug|Upadacitinib|Tablet; Oral
16024555|NCT02706847|Drug|Placebo|Tablet; Oral
16024556|NCT02706834|Drug|TAK-828|TAK-828 oral solution
16024557|NCT02706834|Drug|Placebo|TAK-828 placebo-matching oral solution
16024558|NCT02706821|Dietary Supplement|Persimmon leaf extract|Persimmon leaf extract (PLE), crossover design
16024559|NCT02706821|Dietary Supplement|Placebo|Placebo, crossover design
16024593|NCT02706535|Drug|Rifampicin 300 mg|Rifampicin is available as a red capsule with printed markings and as a 300 mg unit dose strength.
16024560|NCT02706808|Dietary Supplement|'resistance starch for CKD|Intervention period (6 weeks): Group A - patients will receive 6 cookies/day containing resistant starch (18g/day); Group B - patients will receive 6 cookies/day containing placebo
16024561|NCT02706808|Dietary Supplement|Placebo|Intervention period (6 weeks): Group B - patients will receive 6 cookies/day containing resistant starch (18g/day); Group A - patients will receive 6 cookies/day containing placebo
16024562|NCT02706795|Biological|DaxibotulinumtoxinA|Low, mid, and high dose sequential treatments of daxibotulinumtoxinA in dose-escalation safety and efficacy study
16024563|NCT02706782|Drug|TAI-meso-CART|TAI as a local drug delivery pathway, so that more T cells gathered at the tumor site, less T cells to migrate to the normal tissue, thereby enhancing the efficacy of anti-tumor, reducing the potential of side effects. And meso-CART is a 2nd CAR, with mesothelin as target protein, 4-1BB as co- stimulator
16024564|NCT02706769|Drug|Placebo|Study medication contains blinded placebo
16024565|NCT02706769|Drug|Paracetamol|Study medication contains blinded paracetamol
16024566|NCT02706756|Other|Manual therapy|Hip joint and spine manual therapy techniques applied toward the impairments of the subject.
16024567|NCT02706756|Other|Exercise|Prescriptive exercise program of self-mobilization and/or strengthening program to address impairments of the subject.
16024568|NCT02706756|Other|Education and advice|All three groups will receive standardized education on the current state of FAI interventions (with both conservative and surgical care).
16024569|NCT02706756|Other|Supervised neglect|Monitoring of group without formal intervention.
16024570|NCT02706730|Drug|OTO-104|Single intratympanic injection of 12 mg OTO-104
16024571|NCT02706717|Drug|Visbiome Extra Strength|From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily.
16024572|NCT02706717|Drug|Placebo|From week 2 to 4, participant will receive one sachet orally daily. From week 4 to 26, participant will receive one sachet orally twice daily.
16024573|NCT02706704|Drug|Adalimumab|
16024574|NCT02706691|Drug|BGJ398|Given by mouth (oral)
16024575|NCT02706678|Drug|Tacrolimus sustained-release capsule|Oral
16024576|NCT02706665|Other|SEDline monitor|The SEDline monitor gives us the Patient State Index (PSI), a dimensionless number within a range of 0 to100.
16024577|NCT02706626|Drug|brigatinib|Single arm phase 2 trial to investigate the clinical activity in patients with advanced non-small cell lung cancer
16024578|NCT02706613|Behavioral|Face to Face Pulmonary Rehabilitaton|6 week face to face, incremental exercise and education programme for people with COPD
16024579|NCT02706613|Behavioral|Online Pulmonary Rehab|6 week online, incremental exercise and education programme for people with COPD
16024580|NCT02706600|Behavioral|myCOPD|"myCOPD is a system that can be accessed by patients using any device that can connect to the internet and can operate in any internet browser. It contains: Educational information, Inhaler technique videos explaining the correct technique required to use different inhaler devices licensed for use in people with COPD.
~Medication and symptom diaries. Appointment diary Bitesize pulmonary rehabilitation videos designed to promote and support exercises that can be done in a home setting.
~Oxygen Alert Card - Users can create their own oxygen alert card online A 5 Day local weather and pollution reports - Feed for reports come from the met office and DEFRA.
~A Self management plan, which consists of a traffic light system to direct patients to the most appropriate action to take should their symptoms deteriorate. The action plan is populated automatically with the information input by the patients."
16024581|NCT02706600|Behavioral|Written Self management plan|The HealthQuest written self management plan was produced in 2013. It is a one page document which contains a written self management plan which can be individualised for the patient. It consists of a traffic light system to direct patients to the most appropriate action to take should their symptoms deteriorate.
16024582|NCT02706587|Device|Neuromuscular electrical stimulation|NEMS is delivered bilaterally to the quadriceps femoris muscle using a portable battery-powered stimulator (Rehab 400, Cefar Compex, France). The electrodes are placed on the motor points of vastus medialis and vastus lateralis muscles. Electrical stimuli of 45Hz (pulse width: 380 µseconds; 6 seconds on with 1.5 second rise time; and 0.75 seconds fall time.; 5 seconds off). The current is adjusted to ensure maximum tolerable muscle contraction The protocol is applied twice daily for 25 minutes, five days a week.
16024583|NCT02706587|Device|Sham control|No electrostimulation
16024584|NCT02706561|Behavioral|questionnaires|
16024585|NCT02706561|Behavioral|three in-person sessions|
16024586|NCT02706561|Behavioral|monthly phone calls|
16024587|NCT02706561|Behavioral|Acceptance and Commitment Therapy for Erectile Dysfunction (ACT-ED)|
16024588|NCT02706561|Behavioral|Enhanced Monitoring and Education (EME)|
16024589|NCT02706548|Behavioral|Integrative Medication Self Management (IMedS) Intervention|Half of participants received a manualized 30-minute occupational therapy intervention, Integrative Medication Self-Management Intervention (IMedS). During IMedS, the interventionist and client progress through three steps in which the pair: 1) reflect on past performance of medication management, 2) set a medication goal, and 3) generate strategies to reach the goal. During strategy generation, the interventionist uses therapeutic use of self and motivational interviewing to help the client self-generate new medication management strategies, specifically addressing 1) altering the activity, 2) advocacy, 3) education, 4) assistive technology, 5) environmental modifications, and 6) securing timely refills.
16024590|NCT02706548|Behavioral|Standard Care Educational Intervention|The standard care educational intervention was a 30-minute pamphlet based educational session. In the standard care intervention group, participants and interventionist first reviewed the pamphlet, Managing Your Medicines: Our Guide to Effective Medication Management (American Heart Association & American Stroke Association, 2013). Then, the interventionist engaged in active listening, where she asked open-ended questions about the participant's medication routines and provided simple reflections. For the standard care procedures, the interventionist was prohibited from providing affirmations, complex reflections, summaries, problem-solving, or suggesting any specific interventions.
16024591|NCT02706535|Drug|GSK525762 Besylate Tablets|GSK525762 is available as a film-coated, white to slightly colored round, biconvex tablets with no markings. It is available in unit dose strength of 5 mg.
16024592|NCT02706535|Drug|Itraconazole 200 mg|Itraconazole is available as a clear yellow solution with unit dose strength of 10 mg/mL
16115502|NCT02046980|Procedure|Vibration|
16024594|NCT02706522|Dietary Supplement|Allocated to Carbohydrated group|Patients received 400 mL of oral isotonic glucose (No NPO®, Daesang, Korea) 12 hours before anesthesia and 400 mL 2 hours before. CHL composition was standard: 12.5 g of carbohydrate per 100 mL, 12% monosaccharide, 12% disaccharide, 76% polysaccharide, 250 mOsm/kg and 50 kcal.
16024595|NCT02706522|Dietary Supplement|Allocated to Placebo group|Patients received 400 mL of oral flavored water (Placebo) 12 hours before anesthesia and 400 mL 2 hours before
16024596|NCT02706509|Drug|Tramadol|patient will receive oral Tramadol 50 mg an hour before IUD insertion
16024597|NCT02706509|Behavioral|Verbal anesthesia|patient will receive full explanation about the procedure for five minutes before IUD insertion
16024598|NCT02706509|Device|Jaydess|Patient will go through an insertion of Jaydess intrauterine device.
16024599|NCT02706483|Drug|Plecanatide|
16024600|NCT02706470|Drug|Cyclosporin A|Patients will receive oral CsA in a dose of 50mg three times a day for 20-30 days since the occurrence of positive result in human chorionic gonadotropin (HCG) test in urine and 14 consecutive days of elevated basal body temperature. The dosage of CsA will be adjusted according to baseline and peak value of CsA blood concentration. If the baseline blood concentration of CsA is lower than 40ng/ml or the peak blood concentration of CsA is lower than 500ng/ml, the dosage of CsA will be increased to 75 mg three times a day.
16024601|NCT02706470|Drug|Dydrogesterone|Patients will receive oral dydrogesterone 10 mg three times a day for 30 days since the occurrence of positive result in HCG test in urine and 14 consecutive days of elevated basal body temperature.
16024602|NCT02706457|Other|Barthel index for functionality|The Barthel Index for functionality is done standard in all patients after intensive care admission
16024603|NCT02706444|Device|Conventional Balloon angioplasty|After fistulogram, full expansion of drug-coated balloon catheter under fluoroscopy guidance in > 50% venous anastomotic stenosis of hemodialysis graft and ≦4cm from venous anastomosis site in lesion length, confirmed by fistulogram. Then, participants were divided into two groups (Conventional balloon angioplasty or Drug-coated balloon angioplasty)
16024604|NCT02706444|Device|Drug-coated Balloon angioplasty|After fistulogram, full expansion of drug-coated balloon catheter under fluoroscopy guidance in > 50% venous anastomotic stenosis of hemodialysis graft and ≦4cm from venous anastomosis site in lesion length, confirmed by fistulogram. Then, participants were divided into two groups (Conventional balloon angioplasty or Drug-coated balloon angioplasty)
16024605|NCT02706431|Procedure|Hyperventilation|
16024606|NCT02706418|Procedure|Clinical Massage Therapy|
16024607|NCT02706405|Biological|Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing CD4+/CD8+ Central Memory T-lymphocytes JCAR014|Given IV
16024608|NCT02706405|Drug|Cyclophosphamide|Given IV
16024609|NCT02706405|Biological|Durvalumab|Given IV
16024610|NCT02706405|Drug|Fludarabine|Given IV
16024611|NCT02706405|Other|Laboratory Biomarker Analysis|Correlative studies
16024612|NCT02706405|Other|Pharmacological Study|Correlative studies
16024615|NCT02706379|Other|Local cerebral oxygen saturation|take blood culture before antibiotic use;measure the blood lactate;liquid rescisutation as 20ml/kg
16024616|NCT02706353|Drug|APX005M|"Dose Escalation Phase Starting Dose Level of APX005M: 0.1 mg injected directly into 1-3 tumors every 3 weeks (Weeks 0, 3, 6, and 9) for up to 4 doses.
~Dose Expansion Phase Starting Dose Level of APX005M: Maximum tolerated dose from Dose Escalation Phase."
16024617|NCT02706353|Drug|Pembrolizumab|Dose Escalation and Expansion Phase Dose of Pembrolizumab: 2 mg/kg by vein 1 time every 3 weeks (Weeks 0, 3, 6, 9, and 12). First dose of Pembrolizumab given 1-2 days before or after first dose of APX005M.
16024618|NCT02706340|Other|No intervention - observational study only|
16024619|NCT02706327|Device|CAD/CAM Insole|A computer numerical control machine was used to product insoles according to pedobarographic pressure data;35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.
16024620|NCT02706327|Device|Semi-custom Insole|Plantar surfaces of each patient's metatarsophalangeal joints were marked with a thick broad marker, and the participants were asked to stand on a clean paper. The borders of the foot were then drawn, and the medial longitudinal arch length was marked from the anterior aspect of the heel to the first metatarsophalangeal joint. These marks were used in designing and production. 35 Shore A hardness ethyl vinyl acetate was used for the main insole, and 3 mm, 15 Shore A hardness ethyl vinyl acetate was used for covering. Orthotic insoles have been implemented in a pair of sports shoes.
16024621|NCT02706327|Other|Control|15 Shore A hardness ethyl vinyl acetate, implemented in a pair of sports shoes as a placebo insole.
16024622|NCT02706301|Behavioral|Telephone-Based Coping Skills Training (CST)|
16024623|NCT02706288|Other|Weight loss with very low fat plant-based diet and regular exercise|Participants will lose 7-10% of their body weight while on a calorie-restricted very low fat plant-based (PB) diet and performing exercise 6 days/week (4 sessions/week under direct supervision). The macronutrient composition of the diet is approximately 70% of energy from carbohydrate, 15% from protein, and 15% from fat. Food will be provided in the form of take-out meals and will be picked up by participants during weekly study visits with a weight management dietitian. To promote adherence to the diet and exercise intervention, subjects will participate in a lifestyle intervention program that includes dietary and behavioral education topics. Treatment will be provided in weekly individual or group sessions depending on subject availability. (Note: this is the only intervention for the study; the hyperinsulinemic euglycemic clamp is not an intervention but is the gold standard for evaluating insulin sensitivity, a primary study outcome.)
16024624|NCT02706275|Other|External warming|External warming via forced air warming to a goal body temperature 1.5°C greater than the baseline minimum temperature (within previous 24 hours) for 48 hours
16024657|NCT02706015|Drug|Neosaldina® & Placebo|02 tablets of Neosaldina® + 02 tablet of comparator placebo, VO, after the beging of migraine with with mild to moderate pain
16024658|NCT02706002|Device|fluoroscopy|in active group femural stem of hip prosthesis will implanted under fluoroscopy guidance during operation till maximum rasp size reached that fills the medullary canal. ordinary 3-5 sequences per operation
16024659|NCT02706002|Procedure|hip prosthesis|all patients in the study will undergo hip prosthesis
16024625|NCT02706262|Other|Metabolically abnormal obese - Mediterranean diet|The effect of consuming a Mediterranean diet will be examined over 3 different phases: (i) weight maintenance for 4 to 8 weeks, with all meals provided; (ii) controlled 7-10% weight loss with caloric intake reduced by 25% to achieve the desired amount of weight loss in about 4 to 5 months with all meals provided; and (iii) Independent weight loss for about 4 months. During the independent weight loss phase of the study subjects will be asked to continue to consume a Mediterranean diet but will prepare all their food at home. No food will be provided during this portion of the study.
16024626|NCT02706262|Other|Metabolically abnormal obese - Low carbohydrate ketogenic diet|The effect of consuming a low-carbohydrate, ketogenic diet will be examined over 3 different phases: (i) weight maintenance for 4 to 8 weeks, with all meals provided; (ii) controlled 7-10% weight loss with caloric intake reduced by 25% to achieve the desired amount of weight loss in about 4 to 5 months with all meals provided; and (iii) Independent weight loss for about 4 months. During the independent weight loss phase of the study subjects will be asked to continue to consume a low carbohydrate ketogenic diet but will prepare all their food at home. No food will be provided during this portion of the study.
16024627|NCT02706262|Other|Metabolically abnormal obese - Plant-based, very-low-fat diet|The effect of consuming a plant-based, very-low-fat diet will be examined over 3 different phases: (i) weight maintenance for 4 to 8 weeks, with all meals provided; (ii) controlled 7-10% weight loss with caloric intake reduced by 25% to achieve the desired amount of weight loss in about 4 to 5 months with all meals provided; and (iii) Independent weight loss for about 4 months. During the independent weight loss phase of the study subjects will be asked to continue to consume a plant-based, very-low-fat diet but will prepare all their food at home. No food will be provided during this portion of the study.
16024628|NCT02706249|Drug|Enoxaparin|
16024629|NCT02706236|Drug|Pancrelipase|Oral Pancrelipase, 720,000 units spread throughout the day with meals and snacks, taken daily PO for 4 weeks
16024630|NCT02706236|Drug|placebo|Placebo will consist of lactose, spread throughout the day with meals and snacks, taken daily PO for 4 weeks
16024631|NCT02706223|Other|Pharmacist Led|Trial of administering established, licensed treatments by a novel pathway, ie Community Pharmacists, which is hypothesized to improve treatment and retention in treatment of difficult to engage subjects
16024632|NCT02706223|Other|Nurse led|Trial of administering established, licensed treatments by the conventional clinical care pathway, ie Specialist nurses
16024633|NCT02706197|Device|OxyChip|The OxyChip is an investigational device to assess oxygen level in tissues, when measured with Electron Paramagnetic Resonance (EPR).
16024634|NCT02706184|Drug|E. coli Nissle suspension|Patients receive E. coli Nissle suspension
16024635|NCT02706184|Drug|Placebo|Placebo
16024636|NCT02706171|Radiation|CyberKnife|
16024637|NCT02706158|Dietary Supplement|1500 mg Calcium and 1200 IU Vitamin D for 2 months|1500 mg Calcium and 1200 IU Vitamin D for 2 months
16024638|NCT02706158|Behavioral|balanced diet|participants will get a balanced diet according to pregnancy stage
16024639|NCT02706145|Other|Social norming campaign|community-level, three-year social norming campaign, using traditional and emerging media, aimed at changing norms of violence among youth 10-24
16024640|NCT02706132|Biological|Mesenchymal Stem Cells(MSCs)|Six doses of 1*10^6/kg body weight MSCs are given, intravenously.
16024641|NCT02706119|Drug|Subcutaneous glargine insulin|Glargine insuline is an insulin analogue which has a prolonged duration of action. Insulin glargine is obtained by recombinant DNA technology in Escherichia coli.
16024642|NCT02706119|Drug|Regular insulin added to TPN bag|Regular insulin is human insulin produced in Saccharomyces cerevisiae by recombinant DNA technology.
16024643|NCT02706106|Device|Knee brace|Patients will be prepared to receive the device of knee brace with or without a hole in the sit position. This intervention will be blinded. Patients will receive a mask covering their eyes and the knee brace will be placed by the researchers, then the knee area will be covered with a dark clothing bag, so the patient will not be able to guess which type of brace is wearing (with or without a hole). Patient will perform the tests without the mask covering their eyes and only the dark clot bag on their knee.
16024644|NCT02706093|Other|High Intensity Interval Training #1|(HIIT#1) 10 x 1 min. at ~90%HRmax - with low intensity warm-up, recovery, and cool down - total of 25 min/session .
16024645|NCT02706093|Other|Moderate intensity continuous training|Moderate-intensity continuous training (MICT) = steady-state exercise at 60-70%HRmax for 45min. Representing a commonly prescribed exercise program.
16024646|NCT02706093|Other|High Intensity Interval Training #2|(HIIT #2) 5 x 1 min at 90%HRmax + 10 min steady-state exercise at 70%HRmax [25min; ~150kcals; 4d/wk]
16024647|NCT02706093|Other|High Intensity Interval Training #3|(HIIT #3) 5 x 1 min at 90%HRmax [15min; ~90kcals; 4d/wk]
16024648|NCT02706080|Other|emergency|
16024649|NCT02706067|Drug|Orlistat|Participants will receive orlistat on an intermittent basis as 120 milligrams (mg) three times a day: once with breakfast, once with lunch, and once with dinner. In case of weight relapse (increase 2.5 percent [%] or more from Baseline) orlistat will be administered for up to 2 months or until weight regain reaches 0% from Baseline. For special occasions (feasts, birthdays, anniversaries) orlistat will be given for up to 3 days.
16024650|NCT02706054|Other|saline|The patients received an IM injection of saline near the nerve root (periradicular)
16024651|NCT02706054|Drug|Meloxicam|The patients received an IM injection of meloxicam near the nerve root (periradicular)
16024652|NCT02706041|Procedure|Definitive Closure Laparotomy|Subjects randomized to the definitive closure laparotomy arm will have the incision closed at the end of the exploratory laparotomy.
16024653|NCT02706041|Procedure|Damage Control Laparotomy|Subjects randomized to the damage control laparotomy arm will have the incision left open at the end of the exploratory laparotomy. The trauma team will evaluate the patient's clinical course to determine when the incision can be closed.
16024654|NCT02706028|Device|underwater ultrasound|underwater US therapy with an intensity of 0.7 W/cm2 in a total of 10 sessions (10 working days) using a 830 kHz ULTRON home OE-302® device with treatment head size of 4.2 cm2.
16024655|NCT02706028|Device|sham underwater ultrasound|ULTRON home OE-302® device is not turned on
16024656|NCT02706015|Drug|Cefaliv® & Placebo|02 tablet of Cefaliv® + 02 tablet of comparator placebo, VO, after the beging of migraine with with mild to moderate pain
16024660|NCT02705989|Drug|BMS-986195|Specified dose on specified day
16024661|NCT02705989|Other|Placebo|Specified dose on specified day
16024662|NCT02705976|Other|Experimental|The algorithm is based on a model, which is designed to handle time series of daily warfarin intakes and INR values measured at designated time points. Based on these inputs the model is able to suggest a warfarin maintenance dose to achieve target INR value. Model parameters are initially set to population values and gradually, as data is entered into the model, these parameters become patient specific.
16024663|NCT02705976|Other|Active Comparator|Participants were (previously) educated in monitoring the INR values and to adjust the warfarin treatment accordingly to achieve a designated target INR range.
16024664|NCT02705963|Drug|Trametinib|Each tablet is 2mg trametinib to be taken orally once daily.
16024665|NCT02705963|Drug|Trametinib|Each tablet is 0.5mg trametinib to be taken orally once daily. 0.5mg tablets may be used if a dose reduction is required.
16024666|NCT02705963|Drug|Oral Contraceptive (1mg norethindrone, 0.035mg ethinyl estradiol)|Combined oral contraceptive to be taken orally once daily.
16024667|NCT02705950|Drug|Intrathecal baclofen bolus|An intrathecal baclofen bolus injection of 50 µg (1ml) will be injected at L3/L4 level.
16024668|NCT02705950|Other|Placebo|1 ml of physiological saline (isotonic saline) will be injected subcutaneously at L3/L4 level simulating
16024669|NCT02705937|Other|Dairy product|Dairy products are given to patients with the instruction to eat as many products as necessary to provide them with some relief (within a limit of 6 per day) for 14 days
16024670|NCT02705937|Device|Aequasyal mouth spray|The mouth spray will be used by patients as needed (according to the package leaflet) for 14 days
16024671|NCT02705924|Behavioral|psychoeducation|"Participants will attend conferences where experts present the state of the art in various domains:
~Latest knowledge in oncogenetics
~Recommendations and morbidity of prophylactic breast surgeries and annexectomy
~Epidemiology of HBOC and comparative mortality risks with other syndromes/life habits
~How to perform the periodic breast screening
~Assisted medical procreation and embryo selection
~Importance of nutrition and physical activity as risk modulator
~Life habits: how one can increase or lower the cancer risk (tobacco, alcohol...)?
~Description of the assistance program (GENAUV) to help counselees exposed to a high cancer risk follow their medical screening.
~The remaining time after this information, i.e. about half of the week-end, will comprise group activities, in particular role games (Moreno psychodrama approach) and group sharing under the supervision of a psychotherapist."
16024672|NCT02705911|Other|Isometric handgrip exercise|Participants have to perform 4 x 2 minute contractions with alternating hands, separated with 1 minute rest period using a ZonaHealth device;
16024673|NCT02705911|Other|Aerobic endurance training|To perform 150 minutes extra/week at moderate aerobic intensity
16024674|NCT02705898|Behavioral|LPA+Fitbit|
16024675|NCT02705898|Behavioral|HEC|
16024676|NCT02705885|Dietary Supplement|lozenges containing IgY|Patients consumed food supplement lozenges containing IgY after nonsurgical periodontal therapy
16024677|NCT02705885|Dietary Supplement|Placebo IgY|Placebo IgY
16024678|NCT02705872|Drug|Chirocaine 0.07% + Sufentanil 0.3 mcg/ml 10ml/h|Continuous epidural perfusion: Chirocaine 0.07% + Sufentanil 0.3 mcg/ml with a 10ml/hour rate
16024679|NCT02705872|Drug|Chirocaine 0.07% + Sufentanil 0.3 mcg/ml 10ml each 60 minutes|Injection of programmed intermittent boluses in the epidural space, without continuous perfusion, of the same solution (Chirocaine 0.07% + Sufentanil 0.3 mcg/ml): 10ml each 60 minutes
16024680|NCT02705859|Drug|Copanlisib|Copanlisib is supplied as lyophilized preparation in a 6mL injection vial. The total amount of copanlisib per vial is 60mg. The solution for IV infusions is obtained after reconstitution with normal saline solution. Copanlisib will be administered on Days 1, 8 and 15 of each 28-day cycle. Copanlisib will be administered first over 60 minutes followed by the infusion of trastuzumab.
16024681|NCT02705859|Drug|Trastuzumab|Trastuzumab IV weekly (4mg/kg on Cycle 1 Day 1 followed by 2 mg/kg IV weekly from Day 8).
16024682|NCT02705820|Drug|Pembrolizumab|Switch maintenance pembrolizumab treatment
16024683|NCT02705807|Drug|FLOLAN injection with currently marketed diluent|FLOLAN injection (epoprostenol 0.5 or 1.5) prepared with the currently marketed diluent (epoprostenol sodium+ powder of hydrogen [pH] 10.2 - 10.8 diluent) for Injection.
16024684|NCT02705807|Drug|FLOLAN injection with reformulated diluent|FLOLAN injection (epoprostenol 0.5 or 1.5) prepared with the reformulated diluent (epoprostenol sodium + pH 11.7 - 12.3 diluent) for Injection.
16024685|NCT02705781|Device|smARTrack Feeding Tube System|
16024686|NCT02705768|Drug|Carbamazepine|Carbamazepine will be started with a dose of 200 mg/day for one week and then increased to 400 mg/day for one week and then 600mg/day for next two weeks.
16024687|NCT02705768|Drug|Oxcarbazepine|Oxcarbazepine will be started with 10mg/kg daily dose for one week followed by 15mg/kg daily for next one week and then will be increased to 20mg/kg for next two weeks.
16024688|NCT02705755|Drug|TD-9855|
16024689|NCT02705755|Drug|Placebo|
16024690|NCT02705742|Biological|Mesenchymal Stem Cells|1.000.000 (one million) cells/kg, IV of dose in the Peripheral vein and 3.000.000 (three million) cells/kg of dose into the right hepatic artery)
16024691|NCT02705729|Device|Ketac Universal|High-viscous glass ionomer restorative material used as posterior dental filling. This material does not require a dentin conditioning step.
16024692|NCT02705729|Device|Ketac Molar Quick|High-viscous glass ionomer restorative material used as posterior dental filling. This material requires a dentin conditioning step.
16024693|NCT02705716|Other|0.454% w/w stannous fluoride (1100ppm fluoride)|Dentifrice containing 0.454% w/w stannous fluoride (1100ppm fluoride)
16024694|NCT02705716|Other|0.76% sodium monofluorophosphate (1000ppm fluoride)|Dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride)
16024695|NCT02705703|Biological|TAPA-pulsed DC vaccine|A cycle of low-dose cyclophosphamide (100mg/day) by mouth for 5 days starting seven 7 days prior to the DC vaccine cycle to reduce Treg activity. Low-dose cyclophosphamide will be taken every 14 days for six 6 cycles. A total of 6 vaccines containing 1 x 10^7 TAPA-pulsed DC will be administered SQ every 14 days. The DC vaccine is given on Day 1 of the DCV cycle plus low-dose GM-CSF 50mcg/day SQ x 5 days (Day 1 to Day 4). GM-CSF is administered for 5 days to increase monocyte production and dendritic cell precursors to optimize immune responses.
16024734|NCT02705430|Behavioral|life style program using a mobile phone (Eco Mentally and NewMe)|life style program using a mobile phone (Eco Mentally and NewMe)
16024735|NCT02705430|Device|mobile phone|mobile phone
16026152|NCT02695420|Drug|50 mg Omecamtiv Mecarbil|oral tablet
16024696|NCT02705690|Device|iOS Balance Application|"We have designed an iOS application and a belt. The application uses accelerometer data to calculate postural sway. Steps:
~The phone is kept stable against the lower back of the participant using the belt.
~The iOS application gives instructions to user to adopt the correct stance (eg: Standing Unsupported, legs side by side) Once the stance is adopted, the application turns on the accelerometer in the phone to sample acceleration along x (media lateral) and z (anterior posterior) axis.
~These displacements from the mean are used to calculate the Root Mean Square of a person which acts a proxy score for Postural Sway. (Postural sway is defined as the phenomenon of constant displacement and correction of the position of the center of gravity within the base of support)"
16024697|NCT02705664|Drug|Loceryl Nail Lacquer|Topical over entire toenail plates of affected toenails once weekly in the evening (at bed time) after having filled down affected toenails to gently remove as much as affected nails and having cleaned toenails surfaces with the provided cleansing swab
16024698|NCT02705664|Drug|Urea Ointment|Topical over the infected part of the toenails only once daily under occlusion in the evening (at bed time) after having soaked toenails in warm water and having removed the soften infected toenail plates and dried the toenails
16024699|NCT02705664|Drug|Bifonazole Cream|Topical, to be rubbed sparingly over the affected toenail skin (nail bed) once daily in the evening (at bed time) after having cleaned and dried thoroughly toenails
16024700|NCT02705651|Drug|Somatostatin-Analog|A long-acting somatostatin-analog will be applied.
16024701|NCT02705638|Drug|Rituximab|All subjects will receive Rituxan 1,000 mg intravenously on days 1 and 15.
16024702|NCT02705638|Drug|Lenalidomide|All subjects will receive Revlimid 20 mg orally per day on days 1-21, 29-49, and 57-77.
16024703|NCT02705625|Drug|MIV-711|MIV-711 administered orally once daily
16024704|NCT02705625|Drug|Placebo|Placebo manufactured to mimic MIV-711 capsule.
16024705|NCT02705612|Drug|Cisplatin|
16024706|NCT02705612|Radiation|External Beam Radiation Therapy|
16024707|NCT02705612|Radiation|Internal Radiation Therapy|
16024708|NCT02705612|Drug|nimotuzumab|
16024709|NCT02705586|Behavioral|Mindfulness|Mindfulness focuses on helping participants understand their personal reactions to stress, teaches skills that provide means to modify stress reactions, and promotes self-care and feelings of competence and mastery. In addition to weekly class sessions, participants are asked to do an hour of home practice the days that the class does not meet.
16024710|NCT02705573|Drug|Mannitol|In the study, mannitol 20% with a dose of 1g / kg / BW (5 ml / kg / BW) will be compared to placebo with NaCl 0.9% in the dose of 5 ml / kg / BW. The study medication will be administered immediately before organ reperfusion. The follow-up of the study is 24 hours.
16024711|NCT02705560|Other|Cow´s milk (3.9% fat, pasteurized)|600 ml full fat milk (organic, pasteurized, 400 kcal)
16024712|NCT02705560|Other|hard, yellow cheese|100 g Swiss cheese (Le Gruyère medium ripe, 400 kcal)
16024713|NCT02705560|Other|Soy based drink|600 ml Soy drink (540 ml soy milk (232 kcal) supplemented with 60 ml soy and plant based cream (167 kcal)
16024714|NCT02705547|Drug|Rosuvastatin|Daily oral administration of Rosuvastatin (10 mg) for 3 months
16024715|NCT02705534|Drug|Sofosbuvir|400 mg, included in a combination pill with 90 mg ledipasvir
16024716|NCT02705534|Drug|Ledipasvir|90 mg, included in a combination pill with 400 mg sofosbuvir
16024717|NCT02705534|Drug|Ribavirin|1000 mg/day if <75 kg, 1200 mg/day for >75 kg. Divided into two daily doses
16024718|NCT02705521|Device|Exergames- Laptop and MIcrosoft Kinect|Following surgery each patient will have a set of games for them to play using their affecting shoulder. These games have been designed by physiotherapists and shoulder surgeons to improve the functional range of movement in their shoulder
16024719|NCT02705508|Drug|Gemcitabine|1000mg/m2, ivd on day 1 and 8 of each 21 day cycle.
16024720|NCT02705508|Drug|etoposide|100mg/m2，4h-intravenous infusion on day1-3 of each 21 day cycle.
16024721|NCT02705508|Drug|Pegaspargase|2500U/m2 im on day 1 of each 21 day cycle.
16024722|NCT02705508|Radiation|involved-field radiotherapy|Three-dimensional conformal radiotherapy was done by linear accelerator at 2.0 grays (Gy) per daily fraction with 5-6 weeks. The involved- field radiation (IFRT) dose was 50-56 Gy.
16024723|NCT02705495|Other|acupuncture|"Acupuncture will be performed according to the physiological concept of segmental acupuncture. A fixed schema of acupuncture points will be used irrespective of TCM diagnosis. Needles will be inserted approximately 10 mm under the skin. The deqi sensation (a sensation described as numbness, heaviness, and distension) may be obtained, but will not be specifically aimed for. The acupuncture protocol includes body and ear acupuncture."
16024724|NCT02705495|Drug|Cranberry products|Participants will receive Cranberry products (Urgenin Blasenkapseln® and/or Alpinamed Preiselbeer Granulat ®) - use is recommended but not obligatory.
16024725|NCT02705482|Biological|MEDI0562|Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation.
16024726|NCT02705482|Biological|Tremelimumab|Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation.
16024727|NCT02705482|Biological|Durvalumab|Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease (PD), or development of other reason for treatment discontinuation.
16024728|NCT02705469|Drug|ZEN003694|
16024729|NCT02705456|Procedure|Tooth Brushing HA|"2x daily repeated cleaning of all teeth using a standardized electric tooth brush and a non-fluoridated tooth paste containing microcrystalline hydroxylapatite.
~Professional supragingival tooth cleaning once every 4 weeks with a rubber cup followed by the application of a 1% chlorhexidine gel over the duration of the study (24 weeks)."
16024730|NCT02705456|Procedure|Tooth Brushing FL|"2x daily repeated cleaning of all teeth using a standardized electric tooth brush and a fluoridated tooth paste.
~Professional supragingival tooth cleaning once every 4 weeks with a rubber cup followed by the application of a 1% chlorhexidine gel over the duration of the study (24 weeks)."
16024731|NCT02705443|Other|No Intervention|Standard of Care Only
16024732|NCT02705430|Dietary Supplement|EPA and DHA capsules of 2 g/day|EPA and DHA capsules of 2 g/day
16024733|NCT02705430|Behavioral|Stress management phone application (Eco Fusion Mentally)|Stress management phone application (Eco Fusion Mentally)
16026265|NCT02694445|Other|observation|The study is non-interventional.
16024736|NCT02705417|Procedure|preoperative color Doppler ultrasonographic vascular mapping|Preoperative color Doppler ultrasonographic vascular mapping was performed with linear probe. The patient extremity under scrutiny was placed under support, with tourniquet augmentation. Vessels were examined in both short (transverse) and long (longitudinal) axis. Anatomical variations, wall morphology and internal diameters at the antecubital fossa, the proximal (cranial), mid and distal (caudal) third of the arm and forearm were assessed in both extremities. Veins were evaluated for compressibility and adequate drainage to deep venous system. The presence of sclerotic, thrombosed and fibrosed segments were noted. Doppler waveforms were obtained in the long axis and volume flow (VF) calculated for arteries selected for potential access construction.
16024737|NCT02705417|Procedure|physical examination|Arterial pulse examination, differential blood pressure measurements and the Allen test in both extremities. Inspection of the superficial venous system with tourniquet enhancement in the arm was performed during venous assessment.
16024738|NCT02705417|Procedure|medical history|medical history with respects to diabetes mellitus, coronary heart disease, peripheral vascular disease
16024739|NCT02705417|Procedure|native arteriovenous fistula construction|surgigal creation of native arterial and venous anastomoses
16024740|NCT02705417|Procedure|arteriovenous graft placement|surgical placement of arteriovenous graft
16024741|NCT02705404|Genetic|Multifocal Tissue Banking|
16024742|NCT02705378|Drug|Polyethylene glycol|Intervention would be given by oro-gastric (OG) or naso-gastric (NG) tube
16024743|NCT02705378|Drug|naloxegol|Intervention would be given by OG or NG tube
16024744|NCT02705365|Other|Patient Navigation|One to one patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance.
16024745|NCT02705365|Other|Usual Care|Usual care during the study period. After the study period, they will be offered 1:1 patient navigation to obtain lung screening and follow-up of abnormal results, as well as smoking cessation guidance.
16024746|NCT02705352|Drug|5-Fluorouracil|Treatment medication
16024747|NCT02705352|Other|Normal saline|Placebo
16024748|NCT02705339|Drug|Rociletinib|
16024749|NCT02705339|Procedure|Biopsy|Standard of care biopsies will be taken at diagnosis and at the time of disease progression
16024750|NCT02705339|Procedure|Blood draw|-Approximately 4 teaspoons of blood will be drawn before treatment begins and at the time of disease progression to look at cell-free DNA
16024751|NCT02705326|Device|Opti-Speech|Uses visual feedback of the tongue's motion to guide speech sound production
16024752|NCT02705313|Drug|177Lu-DOTA0-Tyr3-Octreotate|The treatment regimen consists of 4 administrations of 7.4 GBq (200 mCi) at the date and time of infusion. The recommended interval between two infusions is 8 weeks, which could be extended up to 16 weeks in case of dose modifying toxicity.
16024753|NCT02705300|Drug|Irinotecan 165 mg/m2 iv|Max. 4 months
16024754|NCT02705300|Drug|Oxaliplatin 85 mg/m2 iv|Max. 4 months
16024755|NCT02705300|Drug|Calcium folinate 200 mg/m2 iv|Max. 6 months
16024756|NCT02705300|Drug|5-fluorouracil 3200 mg/m2|Max. 6 months
16024757|NCT02705300|Dietary Supplement|Tocotrienol|Max. 2 years or at the discretion of the investigator
16024758|NCT02705300|Drug|Placebo|Max. 2 years or at the discretion of the investigator
16024759|NCT02705287|Other|Vitamin D dynamics-pregnant|tracer dose of deuterated vitamin D3
16024760|NCT02705287|Other|Vitamin D dynamics-nonpregnant|tracer dose of deuterated vitamin D3
16024761|NCT02705287|Other|Delivery-placental transfer|tracer dose of deuterated vitamin D3 to women in late gestation
16024762|NCT02705287|Other|Delivery-Vitamin D|women will be dosed with deuterated vitamin D3 at term when they come in for their pre-surgical appointments prior to their scheduled c-section
16024763|NCT02705287|Other|Delivery-25(OH) Vitamin D|women will be dosed with deuterated 25(OH)D3 when they come in for their pre-surgical appointments
16024764|NCT02705274|Drug|Bevacizumab|"Drug: 1.25-mg Bevacizumab Intravitreal injection of 1.25 mg Bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
~Other: Deferred panretinal photocoagulation PRP is deferred until failure/futility criteria for intravitreal injection are met."
16024765|NCT02705274|Procedure|Panretinal photocoagulation|Panretinal photocoagulation (full session completed within 42 days).
16024766|NCT02705261|Behavioral|cognitive-behavior therapy|Internet based program to support parents in developing strategies to help their children
16024767|NCT02705222|Procedure|D&C|Cervical dilatation and fractional endometrial curettage will be done in operation theatre and the curetting will be sent for histopathological examination
16024768|NCT02705222|Procedure|Hysteroscopy|Hysteroscopy will be done in operation theatre and hysteroscopic-guided curettings will also be taken and sent for histopathological examination
16024769|NCT02705209|Other|Cayenne Pepper Cataplasm|Poultice of Kaolin, Cayenne Peppfer (5%) and Water
16024770|NCT02705209|Other|Placebo Cataplasm|Poultice of Kaolin and Water
16024771|NCT02705196|Genetic|delolimogene mupadenorepvec|oncolytic virus encoding TMZ-CD40L and 4-1BBL
16024772|NCT02705196|Drug|gemcitabine|chemotherapy
16024773|NCT02705196|Drug|nab-paclitaxel|chemotherapy
16024774|NCT02705196|Biological|atezolizumab|anti-PD-L1 antibody
16024775|NCT02705183|Radiation|Radiotherapy|Multifractionated post-operative radiotherapy, several weeks after surgery
16024776|NCT02705170|Procedure|index of microvascular resistance|Measurement of the index of microvascular resistance in the left anterior descending artery
16024777|NCT02705157|Procedure|Stabilisation of (impending) pathological fracture|Stabilisation of pathological fracture or impending fracture with prosthesis, plate, intramedullary nail, cement, or other stabilisation method
16024778|NCT02705157|Radiation|Radiotherapy of bone metastasis|Radiotherapy of bone metastasis, single or multi-fractionated
16024779|NCT02705144|Other|analysis of the number of stem cell niches|to assess stem cell compartments in their niches and their proliferative and developmental properties in vitro
16024780|NCT02705131|Device|Balance Chiropractic Therapy|patients are in the sitting position and receive the following treatments.1)Balancing tendon-regulation;2) Balancing osteopathy;3) Balance collaterals-dredging.
16024851|NCT02704546|Drug|Placebo|capsules identical in shape, colour and size to the Ritalin® capsules, which contain only the inactive ingredients of the same formulation.
16115503|NCT02046980|Procedure|Sham|
16024781|NCT02705131|Device|Traction Therapy|patients will received the traction therapy.The patient is sitting and wearing a cloth bag occipital jaw traction comfortable,with head bending forward about 10-15 degrees in comfort.The weight for traction of cervical spondylosis is started at 3 kg, and gradually increased to the maximum weight not more than 6kg according to the standard of 0.5kg each time. The treatment is performed 30 minutes a time per day, 10 times as a course,a total of 2 courses.
16024782|NCT02705118|Device|Automatic Imaging fusion of ultrasonography and MRI|Radiofrequency ablation for hepatic malignancies will be performed with automatic registration registration. Except the imaging registration, all other procedures for RF ablation is same.
16024783|NCT02705118|Device|Manual Imaging fusion of ultrasonography and MRI|Radiofrequency ablation for hepatic malignancies will be performed with manual registration registration. Except the imaging registration, all other procedures for RF ablation is same.
16024784|NCT02705105|Biological|Mogamulizumab + Nivolumab|i.v. administration
16024785|NCT02705092|Other|Subliminal priming with subliminal reward stimuli|Positive words as subliminal reward (displayed for 17 ms).
16024786|NCT02705092|Other|Subliminal priming with supraliminal reward stimuli|Positive words as supraliminal reward (displayed for 150 ms).
16024787|NCT02705079|Other|EEG Monitoring|Value of EEG monitoring as adjunct to standard monitoring
16024788|NCT02705066|Dietary Supplement|Citicoline supplement|
16024789|NCT02705066|Dietary Supplement|Placebo supplement|Cellulose
16024790|NCT02705053|Device|CGM and Insulin Pump|Dexcom G4 Platinum CGM with Share AP Receiver Roche Accu-Chek insulin pump.
16024791|NCT02705053|Device|Closed-Loop Control System|"The devices that will be used in the Closed-Loop Control System include the following components:
~DiAs - a smart-phone medical platform; Dexcom G4 Platinum connected to DiAs via Bluetooth CGM receiver; Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth; Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and Zone-MPC and HMS algorithms running on DiAs (MPC and HMS)"
16024792|NCT02705040|Other|Normal|bone mineral density T>=-1.0
16024793|NCT02705040|Other|Osteopenia|bone mineral density -1.0>T>=-2.5
16024794|NCT02705040|Other|Osteoporosis|bone mineral density T<-2.5
16024795|NCT02705027|Device|Freka®-Trilumina versus Freka®-EasyIn|Direct placement of probe via endoscope
16024796|NCT02705014|Drug|Gonadotropin-releasing Hormone|A regimen of pulsatile GnRH (Fengyuan pharmaceutical company, Anhui province, China) administered subcutaneous via a portable infusion pump (Weichuang Medical Science Company, Shanghai city, China) at a 90-minute interval. The GnRH dosage was initially 10ug per pulse and was progressively adjusted to maintain serum testosterone levels at 6.94-17.35 nmol/L ( 200-500 ng/dL).
16024797|NCT02705001|Other|all admissions except accident and emergency|No additional intervention, retrospective study
16024798|NCT02704988|Procedure|Carnoy Solution|The subjects in this group will undergo intervention by having surgery (colorectal cancer resection) and lymph node clearing technique with Carnoy solution
16024799|NCT02704988|Procedure|GEWF Solution|The subjects in this group will undergo intervention by having surgery (colorectal cancer resection) and lymph node clearing technique with GEWF solution
16024800|NCT02704975|Device|Rehabilitation and Dry Needling|Subjects will receive post-operative rehabilitation that is the standard of care for the surgical procedure they underwent. Rehabilitation will begin within one week after surgery and will continue for the duration of their recovery; two to three treatments a week for approximately 6-9 months. Subjects in this group will also receive dry needling as an adjunct intervention. Dry needling treatment will be performed one time a week for four weeks and will begin four weeks post-operative.
16024801|NCT02704975|Device|Rehabilitation|Subjects will receive post-operative rehabilitation that is the standard of care for the surgical procedure they underwent. Rehabilitation will begin within one week after surgery and will continue for the duration of their recovery; two to three treatments a week for approximately 6-9 months.
16024802|NCT02704962|Drug|full-dose olanzapine|trifluoperazine 5mg/d
16024803|NCT02704949|Radiation|1/4 fluoroscopy dose|Use of 1/4 fluoroscopy dose while ureteroscopy is being performed
16024804|NCT02704949|Radiation|Full-dose|Use of full fluoroscopy dose while ureteroscopy is being performed
16024805|NCT02704923|Drug|Atropine|Atropine eye drops (1%) administered by sublingual way (2 drops) every 6 hours
16024806|NCT02704923|Drug|Placebo|Placebo eye drops characterized by saline administered by sublingual way (2 drops) every 6 hours
16024807|NCT02704910|Behavioral|Subthalamic stimulation|Assess difference of amplitude (in degree) of the postural deviation between both condition of unilateral condition of subthalamic nucleus
16024808|NCT02704897|Other|Wound Assessment Tool|A set of questions relating to the symptoms of wound infection
16024809|NCT02704884|Dietary Supplement|probiotic soy milk|
16024810|NCT02704871|Other|SeptiCyte Lab molecular diagnostic test (non-interventional)|This is not an interventional study. Rather it involves evaluation of a molecular diagnostic test to distinguish between sepsis and infection-negative SIRS based on host response.
16024812|NCT02704832|Other|Geriatrician Intervention|Arm B : The duration of the geriatric intervention will be 12 months. The quality of life will be assessed every 3 months during the first year and at 18 months. The study's follow-up will last until 3 years after the enrollment of the last patient and data on vital status of the patient, weight, place of life and the status of the disease will be collected every 6 months.
16024813|NCT02704819|Other|Decision Support System (DSS)|"The EMBalance DSS is a program which summarises and structures clinical information. The structuring of medical information is based on algorithms that have been developed and are employed via the DSS platform. The non-specialist doctors who use the DSS will be asked to exercise their clinical judgement in order to come up with a diagnosis or management plan. The DSS use has the following characteristics:
~Doctors can pace the process anyway they see fit (e.g. by switching from history taking to examination, stopping at any point, or going back to medical history) or by stopping the process entirely.
~Although the EMBalance platform will propose 2-3 diagnosis (with probability estimation for each), doctors will be asked to either choose one of these or discard and choose their own."
16024852|NCT02704533|Biological|PfSPZ Vaccine|Aseptic, purified, vialed, cryopreserved, radiation-attenuated, Plasmodium falciparum sporozoites, strain NF54
16025430|NCT02700672|Other|Observational study|Observational study: kinematic variables, falls and executive function were analyzed
16024814|NCT02704819|Other|Specialist Audiovestibular Consultation|"After the initial appointment with the non-specialist doctor, all patients will be invited to attend a specialist neuro-otology clinic where they will be seen by an overseeing expert in order to undergo a Gold Standard diagnostic process, and determine the management plan appropriate to the diagnosis, which will be compared to the management plan previously advised by the non-specialist doctor. The overseeing expert will review investigations carried out, results assessed by the non-specialist doctor."
16024815|NCT02704819|Other|DSS Customised Vestibular Physiotherapy|"Customised vestibular exercise programme suggested by the DSS. Such exercises are based on the eye, head, and postural exercises that provoke a patient's symptoms.
~Adaptation exercises incorporating gaze fixation and head movements and postural exercises are prescribed to promote recovery of the vestibule-ocular reflex (VOR) and vestibulo-spinal reflex function. Up to 5 exercises will be practised by the patient at home for approximately 1-2 minutes each, twice daily initially at a slow speed which gradually increases as symptoms improve.
~Patients presenting vestibular migraine will perform a maximum of three exercises. These exercises will be chosen by the DSS from a range of established exercises and chosen according to the patient's symptoms when performing the exercise/type of movement."
16024816|NCT02704819|Other|Standard Physiotherapy Practice|Patient will be referred to a local physiotherapy service by his/her non-specialist doctor within 18 weeks from referral. Standard vestibular rehabilitation practice consists of a customised exercise programme, this is service dependent and tailored for patient's symptoms. The rehabilitation programme might include lifestyle advice and education, sometimes accompanied by a leaflet.
16024817|NCT02704819|Other|Follow-up|All patients will be reviewed after three months follow-up by the overseeing expert.
16024818|NCT02704793|Other|Bilateral 1 Hz Cerebellar rTMS|900 pulses of 1 Hz rTMS on 90% of resting motor threshold (RMT) delivered over each cerebellar hemisphere every day for 5 consecutive days.
16024819|NCT02704793|Other|Sham (electrical stimulation)|900 pulses of 1 Hz electrical stimulation (less than 3 mili amperes) delivered over each cerebellar hemisphere every day for 5 consecutive days.
16024820|NCT02704780|Drug|Misoprostol|2 regimes of misoprostol 400 microgram and 800 microgram injections used for 2 groups of women
16024821|NCT02704767|Drug|Apatinib|a tyrosine kinase inhibitor of VEGF invented by Hengrui pharma in China
16024822|NCT02704767|Drug|Tarceva|
16024823|NCT02704767|Drug|Placebo|
16024824|NCT02704754|Drug|suvorexant|First in class orexin antagonist recently approved by the FDA for the treatment of insomnia
16024825|NCT02704754|Other|placebo|Pill with inactive ingredients
16024826|NCT02704741|Device|CO2RE|The CO2RE system device is intended for dermatological procedures requiring ablation, coagulation and resurfacing of soft tissue, including skin
16024827|NCT02704728|Other|Thetanix|Thetanix is an encapsulated lyophilised formulation of a pure culture of Bacteroides thetaiotaomicron with excipients.
16024828|NCT02704728|Other|Placebo|Placebo is encapsulated microcrystalline cellulose without Bacteroides thetaiotaomicron.
16024829|NCT02704715|Procedure|general anesthesia,orbital operation|to evaluate the pain under general anesthesia
16024830|NCT02704702|Drug|Fimasartan|
16024831|NCT02704702|Drug|Rosuvastatin|
16024832|NCT02704702|Drug|Fimasartan + Rosuvastatin|
16024833|NCT02704689|Device|AccuLIF expandable TLIF cage|AccuLIF TL expandable interbody cage used with autogenous bone and/or allograft (cancellous or corticocancellous allograft chips) and supplemental fixation.
16024834|NCT02704676|Other|marker(CA-125)|measuring CA-125 in pregnant women (normal,mild and sever pre-eclampsia)
16024835|NCT02704663|Procedure|Transumbilical removal of specimen via laparoscopy|Transumbilical removal of a benign adnexal mass from the abdominal cavity in laparoscopy
16024836|NCT02704663|Procedure|Lateral transabdominal removal of specimen via laparoscopy|Lateral transabdominal removal of a benign adnexal mass from the abdominal cavity in laparoscopy
16024837|NCT02704650|Procedure|fluid sample|taking a vaginal fluid sample
16024838|NCT02704637|Device|HS-1000|HeadSense (HS)-1000 device, a proprietary non-invasive brain monitor, is expected to safely and accurately monitor physiological signs of the brain with minimal discomfort to patients, providing information about normal or abnormal brain-related conditions and providing decision-making support for physicians
16024839|NCT02704624|Dietary Supplement|Vitamin D|investigate the relationship between musculoskeletal manifestations, in Crohn population, and the hypovitaminosis D
16024840|NCT02704624|Other|Placebo|compare the musculoskeletal manifestations of the Placebo group with the group receiving Vitamin D
16024841|NCT02704611|Device|Real tDCS|Real tDCS (2mA for 25 minutes on 5 consecutive days/week for 2 weeks with the anode centered over M1 bilaterally. Anodal tDCS for 20 minutes at 1.5mA (15 s ramp in and 15 s ramp out) will be applied daily for 10 consecutive days (5 sessions/week). The anodal electrode 24 cm² with current density of 0.08 mA (2mA/24 cm²) will be placed over the left primary motor area in group I, and the reference electrode (24 cm² will be fixed over the contralateral arm (extracephalic).
16024842|NCT02704611|Device|Sham tDCS|Sham tDCS will be applied using the above described parameters in group. For sham tDCS, the placement of the electrodes, current intensity, and ramp time was identical to real tDCS stimulation group; however, the stimulation lasted only for 30 Sec. However, since none of the patients have been experienced tDCS previously, they were unaware of which stimulation is real and which sham is. The investigator responsible for delivering tDCS had no contact with the patients.
16024843|NCT02704598|Drug|Rivaroxaban|Evaluate the efficacy of the oral anticoagulants in the treatment of deep venous tromboses, assessing clinical signs and symptoms, as so the recanalization rate using DUPLEX SCAN.
16024844|NCT02704598|Drug|Warfarin|Evaluate the efficacy of the oral anticoagulants in the treatment of deep venous tromboses, assessing clinical signs and symptoms, as so the recanalization rate using DUPLEX SCAN.
16024845|NCT02704585|Device|Nellcor|Measurement of pulse oximetry in the delivery room with Nellcor pulse oximeter
16024846|NCT02704585|Device|Masimo|Measurement of pulse oximetry in the delivery room with Masimo pulse oximeter
16024847|NCT02704572|Biological|Zostavax|Zostavax will be administrated by subcutaneous injection.
16024848|NCT02704559|Drug|DWC20155|
16024849|NCT02704559|Drug|DWC20156|
16024850|NCT02704546|Drug|Methylphenidate|oral capsules (per os) each containing 10mg Methylphenidate.
16025049|NCT02703103|Other|Manual chest compressions|2 min of Chest compressions without mechanical chest compression system
16024853|NCT02704533|Biological|PfSPZ Challenge (NF54)|Live, infectious, aseptic, purified, vialed, cryopreserved, Plasmodium falciparum sporozoites, strain NF54
16024854|NCT02704533|Biological|PfSPZ Challenge (7G8)|Live, infectious, aseptic, purified, vialed, cryopreserved, Plasmodium falciparum sporozoites, strain 7G8
16024855|NCT02704533|Other|Normal saline|0.9% sodium chloride
16024856|NCT02704520|Drug|Capecitabine|Coated tablet. Systemic chemotherapy
16024857|NCT02704520|Drug|Oxaliplatin|Concentrate for Solution for Infusion. Systemic chemotherapy
16024858|NCT02704520|Drug|5-fluorouracil|Infusion. Systemic chemotherapy
16024859|NCT02704520|Drug|Folinic Acid|Solution for infusion.
16024860|NCT02704507|Drug|Triamcinolone|topical application nightly to half the face for 4 weeks
16024861|NCT02704507|Drug|Tretinoin|topical application nightly for 8 weeks
16024862|NCT02704507|Drug|Emollient|topical application nightly to half the face for 4 weeks
16024863|NCT02704494|Drug|Resveratrol|Resveratrol 500mg daily
16024864|NCT02704494|Drug|Placebo|Placebo 1 capsule daily
16024865|NCT02704494|Drug|Losartan|Losartan 12.5mg daily
16024866|NCT02704481|Drug|Mifepristone|200mg oral mifepristone
16024867|NCT02704481|Drug|Misoprostol|800mcg buccal misoprostol
16024868|NCT02704481|Drug|Placebo mifepristone|Matching placebo pill of 200mg mifepristone
16024869|NCT02704481|Drug|Placebo misoprostol|Matching placebo pills of 800mcg misoprostol
16024870|NCT02704468|Other|CAVI and FGF-21|FGf-21 and CAVI was measured in renal transplant patients group and study correlation with arterial stiffness
16024871|NCT02704429|Drug|PRN1008|Part A: PRN1008, oral dose, 12 weeks; Part B: PRN1008, oral dose 24 weeks
16024872|NCT02704416|Procedure|Catheter Ablation|catheter ablation of fragmented signal in the right ventricular outflow tract
16024873|NCT02704403|Drug|Elafibranor|
16024874|NCT02704403|Drug|Placebo|
16024875|NCT02704390|Drug|ORADUR®-Methylphenidate|ORADUR®-Methylphenidate is available in three dosage forms, 22 mg, 33 mg or 44 mg. Subjects will continue to receive ORADUR®-Methylphenidate at the previously determined optimal dose for 24 months.
16024876|NCT02704377|Other|Undergo HRV and wear accelerometer to assess therapy complications|Wear accelerometer undergo heart rate variability(HRV) testing over 10-15 minutes while both lying down and standing, complete a walking test, wear an accelerometer for a period of 1 week
16024877|NCT02704377|Procedure|Dual X-ray Absorptiometry|Undergo iDXA
16024878|NCT02704377|Other|Laboratory Biomarker Analysis|Correlative studies
16024879|NCT02704377|Other|Quality-of-Life Assessment|Ancillary studies
16024880|NCT02704377|Other|Questionnaire Administration|Ancillary studies
16024881|NCT02704364|Biological|NGM282|
16024882|NCT02704364|Other|Placebo|
16024883|NCT02704351|Procedure|Surgery|Sugammadex to reverse neuromuscular blockade
16024884|NCT02704338|Biological|Regulatory T cells|Regulatory t cells will be injected back to autoimmune hepatitis patients
16024885|NCT02704325|Biological|rAAVrh74.MCK.GALGT2|Direct intramuscular injection of rAAVrh74.MCK.GALGT2 transferred to the extensor digitorum brevis muscle (EDB) of one foot and the other side receiving saline alone.
16024886|NCT02704325|Other|PLACEBO (Saline)|Direct intramuscular injection of rAAVrh74.MCK.GALGT2 transferred to the extensor digitorum brevis muscle (EDB) of one foot and the OTHER side receiving saline alone.
16024887|NCT02704312|Radiation|Radiotherapy by Prone and decubitus|Dosimetric comparison of doses in target volumes and organs at risk
16024888|NCT02704299|Biological|Autologous T cells-Based Immunotherapy|TCM cells are the subpopulation of T lymphocytes with key characteristics including high potency and long-term memory of specific immunity.
16024889|NCT02704286|Behavioral|Internet-Based Osteoarthritis Risk Calculator|The investigators have developed a personalized risk calculator for knee osteoarthritis. This risk calculator uses the Osteoarthritis Policy Model to estimate an individual's risk of developing knee osteoarthritis within their lifetime based on demographic information and risk factors. It shows this information to the user with interactive graphs and compares their risk to the risk of an average American of the same age.
16024890|NCT02704286|Behavioral|Generic osteoarthritis information|Subjects viewed generic (i.e. not personalized) information about osteoarthritis risk factors
16024891|NCT02704260|Genetic|GENETIC ANALYSIS|prélevement blood to search for a genetic cause of vascular endofibrose. Search genetic mutations in 5 subjects.
16024892|NCT02704247|Device|CARDIOSPACE System|"autonomic nervous system test
~tilt test
~ultrasound exploration at rest (heart / vessels)
~laser doppler + iontophoresis test
~sub-maximal exercise test"
16024893|NCT02704234|Other|Active Acupuncture|Active Acupuncture two times per week for 5 weeks
16024894|NCT02704234|Other|Placebo Acupuncture|Placebo Acupuncture two times per week for 5 weeks
16024895|NCT02704221|Behavioral|Fitbit activity tracker|Wear a Fitbit daily for 12 weeks and meet with a research assistant once per week to download data
16024896|NCT02704221|Behavioral|Monetary rewards|Set weekly step-count goals based on the previous week's performance and receive monetary rewards for meeting the goals. The schedule of rewards increases as step-count goals increase.
16024897|NCT02704221|Behavioral|BPT training sessions|Complete 12 BPT training sessions delivered by supervised clinical child psychology doctoral students, with each session lasting approximately 60 minutes. The BPT is based upon the existing, evidence-based Everyday Parenting intervention.
16024898|NCT02704208|Behavioral|Thrive With Me Control|Those assigned to the TWM control group will receive a weekly email with static HIV informational content. Information will be focused more on quality of life and general wellbeing issues and will not be specific to medication adherence.
16024899|NCT02704208|Behavioral|Thrive With Me Intervention|Those assigned to the TWM intervention will have 150 days to access tailored content on a mobile-enhanced website. They will also have social support through a network of other HIV-positive men. Finally they will track their daily ART medication adherence and mood through SMS and website use.
16024900|NCT02704195|Procedure|Unilateral reduction of stimulation|30% unilateral reduction of Subthalamic nucleus stimulation
16024901|NCT02704195|Procedure|Chronic Subthalamic nucleus stimulation|This arm is the reference, with the best stimulation parameters
16024902|NCT02704182|Device|tDCS|25 patients received real anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days.
16024903|NCT02704182|Device|Sham tDCS|25 patients received sham anodal tDCS on the motor area for 20 minutes every day for 4 consecutive days.
16024904|NCT02704169|Other|Spatially registered endoscopy|
16024905|NCT02704156|Device|Cyberknife plus Pembrolizumab and Trametinib|Radiation therapy plus drug
16024906|NCT02704156|Device|Cyberknife plus Gemcitabine|Radiation therapy plus drug
16024907|NCT02704143|Other|combination of Cyberknife with S-1|Radiation therapy combined with chemotherapy
16024908|NCT02704130|Device|Transarterial embolization|In transarterial bland embolization, beads are delivered directly into the arterial vessels feeding the tumor, usually by a percutaneous coaxial catheter system guided by ultrasound or fluoroscopy through the common femoral artery.
16024909|NCT02704130|Procedure|Microwave Ablation|Microwave ablation is a form of thermal ablation used to treat cancer. In this procedure, electromagnetic waves in the microwave energy spectrum (300 MHz to 300 GHz) are applied to tumor tissue. The oscillation of polar molecules produces frictional heating, ultimately generating tissue necrosis within solid tumors.
16024910|NCT02704117|Device|Transcranial Magentic Stimulation|This is a form of mild brain stimulation delivered noninvasively. The device delivers pulses of magnetic energy through a coil placed on the scalp. The treatment takes 41 seconds, and takes place for ten sessions, Monday through Friday, over the course of two weeks
16024911|NCT02704104|Device|AC5 Topical Hemostatic Device|Randomized application of the hemostatic agent AC5 to one of two freshly excised lesions in each patient
16024912|NCT02704091|Drug|Smecta|
16024913|NCT02704091|Drug|Smecta placebo|
16024914|NCT02704078|Device|EBUS-TBNA|EBUS-TBNA - Patients in the Active comparator arm shall undergo mediastinal lymph node aspiration transtracheally using the EBUS scope
16024915|NCT02704078|Device|EUS-B-FNA|EUS-B-FNA - Patients in the experimental arm EUS-B-FNA shall undergo mediastinal lymph node aspiration transesophageally using the EBUS scope
16024916|NCT02704052|Drug|Real time enoxaparin dose adjustment|Patients will have steady state peak and trough anti-Xa levels drawn after their third enoxaparin dose. Patients with out of range peak anti-Xa levels will receive real time enoxaparin dose adjustment followed by repeat peak and trough anti-Xa levels.
16024917|NCT02704052|Drug|Standard enoxaparin dose|Patients will be placed on enoxaparin prophylaxis per their surgeon's discretion.
16024918|NCT02704026|Other|Assesment of nutritional status and body composition|At the time of enrollment and after 1 year, anthropometric measurements and assessment of body composition by bioelectrical impedance will be performed for each child
16024919|NCT02704013|Drug|Oxybutynin|Anticholinergic
16024920|NCT02704000|Behavioral|Home visiting program (Jamaica curriculum)|Agents will deliver bi-weekly home-visits following the curriculum developed for the Jamaica intervention study by Susan Walker and colleagues. This curriculum foresees age-appropriate tasks assigned to the caregiver during each visit.
16024921|NCT02703987|Other|Fermented infant milk formula|
16024922|NCT02703987|Other|Non-fermented infant milk formula|
16024923|NCT02703974|Behavioral|Early handwashing station|"A handwashing station will be a dedicated location for handwashing in each selected school and will include:
~A raised concrete platform (built to child height)
~A plastic container with a lid and spigot
~Soap
~The early handwashing stations will be constructed in weeks 1 and 2 of the study, after the baseline observations (Phase I) are complete."
16024924|NCT02703974|Behavioral|Late handwashing station|"A handwashing station will be a dedicated location for handwashing in each selected school and will include:
~A raised concrete platform (built to child height)
~A plastic container with a lid and spigot
~Soap
~The late handwashing stations construction will begin after Phase 2 data collection has been finished at the end of week 3."
16024925|NCT02703974|Behavioral|Nudge|"A nudge will be built in each randomly selected school and will consist of:
~Connecting latrines to the handwashing station via paved pathways that are painted bright colors
~Painting footprints on infrastructure guiding students to the handwashing stations and handprints on stations
~The nudges will be constructed at the end of week 3 and 4, after Phase II data collection is complete within each randomly assigned nudge school."
16024926|NCT02703974|Behavioral|Education|"Hand hygiene education-based program: the hygiene promotion element will include a one month program of handwashing education involving weekly facilitator led sessions. Each session will be about 30-45 minutes long, and will cover the following topics:
~Importance of handwashing
~Method of handwashing
~Critical times of handwashing
~Finding solutions for handwashing in school and at home The sessions will involve use of flipcharts, and other IEC materials (e.g. videos) and participative learning methods.
~The Hand hygiene education-based program will begin at the beginning of weeks 4 and 5, after Phase II data collection is complete in each randomly assigned education school."
16024927|NCT02703961|Drug|concurrent chemotherapy with cisplatin|in experimental group: cisplatin 60mg/m2, d1,d22;
16024928|NCT02703961|Drug|concurrent chemotherapy with docetaxel|in experimental group: docetaxel 60mg/m2, d1,d22;
16024929|NCT02703961|Radiation|pelvic radiotherapy|external beam radiotherapy for whole pelvix with 50Gy/25f boost radiotherapy for pelvic lymph node metastasis with 12-14Gy/4-7f.
16024930|NCT02703961|Radiation|brachytherapy|CT/MRI guided brachytherapy or x-ray guided brachytherapy
16024931|NCT02703961|Drug|adjuvant chemotherapy with cisplatin and docetaxel|cisplatin 75mg/m2, d43,d64; docetaxel 75mg/m2, d43,d64
16024932|NCT02703948|Device|Restylane Silk with Lidocaine|
16024933|NCT02703935|Behavioral|health talk and adventure-based training|To develop an integrated programme for Hong Kong Chinese childhood cancer survivors, an advisory committee was set up which included an associate professor, an assistant professor and a research student at a local university, a pediatric oncologist and oncology nurse and one assistant professor of Sports and Recreation Management, ensuring the adequate 'dosage' of the intervention and the feasibility of implementing such programme for Hong Kong childhood cancer survivors.
16024934|NCT02703935|Behavioral|Placebo Control|They will be invited to attend leisure activities organized by a community centre in four different days during the study period. Activities will include cartoon film shows, handicraft workshops, chess games, health talks on the prevention of influenza and healthy diet, day visit to museums and theme parks and galleries
16024935|NCT02703922|Other|color Doppler ultrasound and TAB in case of CDU negative|Screening with color Doppler ultrasound followed by TAB in case of CDU negative
16024936|NCT02703909|Drug|Rocuronium|Rocuronium will be administered to achieve either a moderate (2-3 twitches) or deep (0-1 posttetanic) block depending on the group assignment
16024937|NCT02703909|Device|Insufflation pressure|The initial insufflation pressure will be set at either 10 or 15 mm Hg depending on the group assignment
16024938|NCT02703896|Drug|Drug either PPIS or H2RA and prokinetics|"Drug intervention ( dose unit mg) Two oral doses 8:00 p.m. and 6:00 a.m. (n=60) total 10 groups
~Group C (placebo),Group L (lansoprazole15 ), Group LD (Lansoprazole 15 +domperidone 10 )
~Group C ,R (rabeprazole 10), RM (rabeprazole 10 + metoclopramide 10)
~Group C , E (esomeprazole 20 ), and EM (esomeprazole 20 + metoclopramide 10)
~Group C, P (pantoprazole 20), and PD (pantoprazole 20 + domperidone 10 mg)
~Group C, O (omeprazole 20), OD (omeprazole 20 + domepridone 10), OM (omeprazole 20 + metoclopramide 10)
~Group C,T (cimetidine 200), TD (cimetidine 200 + domperidone 10)
~Group C , Z (ranitidine 150), ZD (ranitidine 150 + domperidone 10)
~Group C , N (nizatidine 150),NM (nizatidine 150 + metoclopramide 10)
~Group C, F (famotidine 20 mg), and FM (famotidine 20 mg + metoclopramide 10)
~Group C,S (lafutidine 10), SD (lafutidine 10 + domperidone 10), and Group SM (lafutidine 10 + metoclopramide 10)"
16024939|NCT02703896|Procedure|orogastric intubation|OGT insertion:Insertion of orogastric tube(through an endotracheal tube placed in the upper esophagus) into the stomach after general anaesthesia.
16024940|NCT02703883|Device|BWST|BWST (six weeks, 3 times/week)
16024941|NCT02703870|Device|verum tDCS|real transcranial direct current stimulation,10 sessions, 2mA for 20 minutes
16024942|NCT02703870|Device|sham tDCS|sham transcranial direct current stimulation, 10 sessions, for 20 minutes
16024943|NCT02703870|Behavioral|VRT|Vision restoration training, 10 sessions, 20 minutes
16024944|NCT02703857|Drug|cefoxitin|Parenteral administration of 2g of cefoxitin at least 30 minutes before incision and then every 2 hours until closing
16024945|NCT02703844|Device|Caloric Vestibular Stimulation|Stimulation of the vestibular nerves
16024946|NCT02703844|Device|Sham Caloric Vestibular Stimulation|Sham stimulation of the vestibular nerves
16024947|NCT02703831|Procedure|Dual attending|Two attending spine surgeons perform surgery
16024948|NCT02703831|Procedure|Single Attending|One spine attending and an assistant perform surgery. The assistant can be a spine fellow, a resident or a physician's assistant.
16024949|NCT02703818|Device|Senza|Spinal Cord Stimulation
16024950|NCT02703805|Other|Fit For Function Program|A 12-week YMCA-based wellness program for persons with stroke, consisting of 2 group exercise sessions, one gym exercise session and one education session per week with trained instructors
16024951|NCT02703805|Other|Standard YMCA membership|A 12 week standard YMCA membership.
16024952|NCT02703779|Drug|Bortezomib|Bortezomib will be given to Group B participants by injection under the skin 11 days and 8 days before stem cell collection.
16024953|NCT02703779|Drug|Granulocyte colony-stimulating factor (G-CSF)|Granulocyte colony-stimulating factor (G-CSF) will be given to all participants by injection under the skin 4 days and 1 day before stem cell collection, and then continued until the stem cell collection is completed.
16024954|NCT02703779|Drug|Mozobil|Mozobil will be given to all participants by injection under the skin only if needed per Investigator.
16024955|NCT02703766|Behavioral|overfeeding induced weight gain|
16024956|NCT02703753|Behavioral|Lifestyle intervention|The investigational treatment consists of a lifestyle intervention targeting on a healthy diet, physical activity and, if applicable, smoking cessation.
16024957|NCT02703740|Device|Hyaluronic acid dermal filler with lidocaine 0.3%|injection in labial fold of a dermal filler
16024958|NCT02703727|Behavioral|Extended polymedication check|"Behavioral: Medication review
~Patients on oral anticoagulants and polypharmacy will receive extended polymedication check to identify Pharmaceutical Care Issues, Adherence Issues, Drug related problems and Knowledge Gaps
~The PMC has been implemented in 2010 as a new cognitive service provided by any community pharmacist to patient with polypharmacy (n>3 drugs) on long term conditions (> 3 months) and is reimbursed by swiss health insurance. The semi-structured interview contains questions about knowledge on oral anticoagulation therapy. This extended PMC follows a structured predefined protocol.
~As an outcome, pharmacist may install a compliance support e.g. weekly filled pill organizer."
16024959|NCT02703714|Drug|Pembrolizumab|200 mg given IV
16024960|NCT02703714|Drug|Sargramostim|250 µg given SC
16024961|NCT02703701|Behavioral|Physician at triage|A physician embedded at triage
16024962|NCT02703701|Other|Usual Care|No physician at triage
16024963|NCT02703688|Behavioral|Healthy Homes|The Healthy Homes Behavioral Intervention (HHBI) will be delivered during 8 sessions over 10 weeks using home visitations. The first 6 sessions occur weekly and provide education about healthy dietary intake including caloric recommendations for preschool aged children, healthy sleep goals, active play and screen time limits, and family routines and organization. Each session will include a parent-child interaction component to teach child behavior management skills related to intervention goals. Two final sessions occur every other week to provide problem solving and planning for maintenance of treatment effects.
16024964|NCT02703688|Other|Usual Care|A pediatrician with experience delivering weight management treatment to children will deliver a single session, 1-hour treatment to families. Content to be delivered during the session will include lifestyle recommendations currently recommended by the AAP.
16024965|NCT02703675|Device|Excel Cryo Cooling Collar|Therapeutic hypothermia in the study will be initiated by The Excel Cryo Cooling system consisting of a unique cervical immobilization collar and a cooling element. Once activated, the cooling element achieves a temperature of -3.0 °C to -5.0 °C within seconds. The collar is fitted around the subject's neck and the cooling element is applied the the front of the neck over the carotid arteries and secured in place by the collar. The Excel System provides consistent cooling regardless of patient size or weight, by cooling of the blood traveling through the carotid triangles.
16024966|NCT02703662|Device|Strattice biologic mesh|Patients randomized to this group will be inserted one or more Strattice biologic meshes during the abdominal wall reconstruction surgical procedure.
16024967|NCT02703662|Device|Permacol biologic mesh|Patients randomized to this group will be inserted one or more Permacol biologic meshes during the abdominal wall reconstruction surgical procedure.
16024968|NCT02703649|Drug|Letrozole|After the decision to use Letrozole for induction of ovulation, we will obtain informed consent and randomize the patents into 2 groups Single 20 mg dose of Letrozole on day 3 of the cycle Daily dose of Letrozole 2.5 mg starting day 3 for 5 days.
16025050|NCT02703103|Device|ARM chest compressions|2 min of Chest compressions with mechanical chest compression system LifeLine ARM
16025051|NCT02703090|Drug|Remifentanil|
16024969|NCT02703636|Drug|Rivastigmine Patch|Alzheimer's disease patient who is applicable to 1 step titration method (initial loading dose is a rivastigmine patch 9.0 mg/day and will be up-titrated after 4 weeks to reach the maintenance dose of 18 mg/day). Rivastigmine patch is a marketed drug, therefore the dose, dose regimen and titration scheme are in accordance with product label.
16024970|NCT02703623|Drug|Abiraterone Acetate|Given PO
16024971|NCT02703623|Drug|Apalutamide|Given PO
16024972|NCT02703623|Drug|Cabazitaxel|Given IV
16024973|NCT02703623|Drug|Carboplatin|Given IV
16024974|NCT02703623|Biological|Ipilimumab|Given IV
16024975|NCT02703623|Other|Laboratory Biomarker Analysis|Correlative studies
16024976|NCT02703623|Drug|Prednisone|Given PO
16024977|NCT02703610|Drug|Oxycodone/acetaminophen|Patients will be discharged home with a 3 day supply of oxycodone/acetaminophen
16024978|NCT02703610|Drug|Ibuprofen/acetaminophen|Patients will be discharged home with a 3 day supply of ibuprofen/acetaminophen
16024979|NCT02703597|Behavioral|Surveys|Surveys include questions related to tobacco use behavior and attitude toward tobacco, as well as demographic and personality questions. Psychosocial surveys and social network surveys are also completed to capture adolescents' network of friends and opinion leaders.
16024980|NCT02703597|Behavioral|ASPIRE|Participants engage in four to five 70-minute sessions of ASPIRE spread over a period of 4 weeks. During ASPIRE use, participants face a screen and individually watch videos and engage in computer-based activities related to the negative effects of tobacco.
16024981|NCT02703597|Behavioral|GSA-ASPIRE-Network|In groups, participants engage in four to five 70-minute sessions of ASPIRE conducted over a period of 4 weeks. However, during each session, ASPIRE use is coupled with game-based social activities (GSAs). During ASPIRE use, participants watch videos and engage in computer-based activities on the same computer screen. Also, in groups, participants engage in the paper-based GSAs as a team and collaborate as they complete the activities. The GSAs contain games about the effects of tobacco. Groups are allocated based on adolescents' network of friendships.
16024982|NCT02703584|Drug|Buseralin|
16024983|NCT02703584|Other|Placebo|
16024984|NCT02703584|Drug|pregnyl|
16024985|NCT02703571|Drug|ribociclib|Combination treatment with LEE and TMT
16024986|NCT02703571|Drug|Trametinib|Combination treatment with LEE and TMT
16024987|NCT02703558|Drug|Phenazopyridine|
16024988|NCT02703558|Drug|Fluorescein|
16024989|NCT02703532|Behavioral|CARE-CITE Education Program|"CARE-CITE is an online educational program developed to provide information that may help caregivers understand more about constraint-induced movement therapy (CIMT) and their potential roles in helping the stoke survivor gain as much benefit as possible from CIMT.
~If participants do not have access to a computer or tablet, they will be loaned an electronic tablet for the 2-3 week period of the study to access the information.
~Participants will be asked to review six educational modules over a period of 2-3 weeks while the stroke survivor receives CIMT.
~Participants will attend three in home evaluation visits; one at the beginning of the stroke survivors therapy sessions, one at the end of his/her therapy visit series, and a third evaluation one month later in which they will be asked to complete questionnaires. Evaluation visits will take approximately 1 ½ hours to complete."
16024990|NCT02703532|Behavioral|Traditional Education|Investigators will explain constraint-induced movement therapy (CIMT) to caregivers and stroke survivors during the first home therapy session for the stroke survivor and provide traditional educational information about CIMT during therapy sessions as needed.
16024991|NCT02703532|Behavioral|Constraint-Induced Movement Therapy (CIMT)|"Constraint-Induced Movement Therapy (CIMT) is one type of therapy that helps stroke survivors gain more use of their weaker arm.This therapy involves wearing a soft mitt (like a sock or oven mitt) on the stronger arm to remind the stroke survivor to use their weaker arm for daily activities and also intensive practice of tasks with the supervision of a therapist.
~Participants will attend three in home evaluation visits; one at the beginning of your therapy sessions, one at the end of your therapy visit series and a third evaluation one month later. These evaluation sessions will involve an evaluation of arm function and answering three questionnaires about how well the weaker arm works and how the stroke has affected daily activities. The interview questions and assessment will take approximately 1 ½ hours to complete."
16024992|NCT02703519|Procedure|resection of uterine scar tissue|resection of uterine scar tissue of a previous cesarean section during a second cesarean section
16024993|NCT02703506|Other|Session of Pain Education programe|Five group sessions of patient education pain of 60-120 minutes one for week with a maximum of 10 participants.
16024994|NCT02703506|Other|Control Group|Five individual sessions twice a week, will be performed of transcutaneous electrical nerve stimulation (TENS) on neck area an exercises
16024995|NCT02703493|Radiation|Stereotactic Radiosurgery|Patients will receive 6 weeks of IMRT (standard of care) followed by the stereotactic radiosurgery (SRS Boost). Dose of the boost is reliant on which cohort the patient is assigned to. Cohort 1 will receive 8 Gy, Cohort 2 will receive 10 Gy in a single fraction, Cohort 3 will receive 10 Gy split into two fractions.
16024996|NCT02703480|Biological|d-PTFE|high-density polytetrafluoroethylene (d-PTFE) membrane
16024997|NCT02703480|Biological|Ti-mesh|Titanium mesh
16024998|NCT02703454|Procedure|FIRM-guided RF ablation|
16024999|NCT02703454|Procedure|Conventional RF ablation|
16025000|NCT02703441|Other|Tablet computer|Patients randomized to the intervention group will receive a tablet computer with an app-like software solution supporting nutrition and physical activity. The patients operate the computer and order their meals from the hospital menu; register dietary intake, and receive feedback informing about their current status for protein and energy intake. Likewise, the patients use small series of brief videos instructing in daily life activities for strengthening their muscles. After this, they register their performed activities and will receive informing and motivating feedback. Nudging and prompting is part of the solution.
16025001|NCT02703415|Drug|Bupivacaine|caudal block with bupivacaine (0.25%) 1mg/kg
16025002|NCT02703415|Drug|Tramadol|caudal block with tramadol 1 mg/kg
16025003|NCT02703402|Other|Exercise protocol|Control group will complete all the protocol of exercises with orientation and attendance directly from a professional of physical education, in the Service of Physiatry and Rehabilitation in HCPA.
16025052|NCT02703090|Drug|Normal saline|
16025053|NCT02703077|Procedure|Spyglass|Endoscopic direct view of the bile ducts
16025004|NCT02703402|Other|Manual of exercises|Treatment group will complete one session of the protocol of exercises with orientation and attendance directly from a professional of Physical Education, in the service of Physiatry and Rehabilitation of HCPA, to clarify any doubts about the protocol. The further sessions will be completed at home, along weekly monitoring of the researchers through phone calls, the patients of this group will receive a manual with the sequence of the exercises
16025005|NCT02703389|Behavioral|Video|Animated video explaining acute otitis media and antimicrobial stewardship.
16025006|NCT02703389|Behavioral|Pamphlet|Contains same information as video.
16025007|NCT02703376|Drug|Oral Prednisone|Intakes of Oral Prednisone for 12 weeks after balloon dilations
16025008|NCT02703363|Drug|Minocycline|
16025009|NCT02703363|Drug|Celecoxib|
16025010|NCT02703363|Drug|Placebo|
16025011|NCT02703350|Drug|LY900014|Administered subcutaneously (SC)
16025012|NCT02703350|Drug|Insulin Lispro|Administered SC
16025013|NCT02703337|Drug|LY900014|Administered subcutaneously (SC)
16025014|NCT02703337|Drug|Insulin Lispro|Administered SC
16025015|NCT02703324|Drug|LY900014|Administered subcutaneously (SC)
16025016|NCT02703324|Drug|Insulin Lispro|Administered SC
16025017|NCT02703311|Device|Cardioband|Mitral valve repair with Cardioband implanted via transcatheter procedure under transesophageal echocardiography (TEE) and fluoroscopy guidance
16025018|NCT02703298|Drug|TRX-818 capsules|
16025019|NCT02703285|Other|Sound|task of the participants in the study to determine the chest sound based on specific sounds: Vesicular - Diminished; Expiratory Wheeze; Bronchovesicular; pneumonia; pulmonary Oedema; Stridor; Agonal respiration
16025020|NCT02703272|Drug|Ibrutinib|Participants will receive Ibrutinib (dose 240 mg/m^2 /329 mg/m^2 per day) during part 1 and part 2.
16025021|NCT02703272|Drug|Rituximab|Participants will receive a cumulative dose of rituximab 750 mg/m^2 as a part of RICE/RVICI regimen in part 1 and part 2 per cycle.
16025022|NCT02703272|Drug|Ifosfamide|Participants will receive a cumulative dose of Ifosfamide 9 g/m^2 and 10 g/m^2 as a part of RICE and RVICI regimen respectively in part 1 and part 2 per cycle.
16025023|NCT02703272|Drug|Carboplatin|Participants will receive a cumulative dose of carboplatin 635 mg/m^2 and 800 mg/m^2 as a part of RICE and RVICI regimen respectively in part 1 and part 2 per cycle.
16025024|NCT02703272|Drug|Etoposide|Participants will receive a cumulative dose of etoposide 300 mg/m^2 in part 1 and part 2 as a part of RICE regimen per cycle.
16025025|NCT02703272|Drug|Vincristine|Participants will receive a cumulative dose of vincristine 1.6 mg/m^2 in part 1 and part 2 as a part of RVICI regimen per cycle.
16025026|NCT02703272|Drug|Idarubicin|Participants will receive a cumulative dose of idarubicin 20 mg/m^2 in part 1 and part 2 as a part of RVICI regimen per cycle.
16025027|NCT02703272|Drug|Dexamethasone|Participants will receive a cumulative dose of dexamethasone 100 mg/m^2 in part 1 and part 2 as a part of RICE/RVICI regimen per cycle.
16025028|NCT02703259|Drug|Gabapentin|
16025029|NCT02703259|Drug|Acetaminophen|
16025030|NCT02703259|Drug|Celecoxib|
16025031|NCT02703246|Procedure|abdominal morcellation|patients will be randomized to receive abdominal morcellation
16025032|NCT02703246|Procedure|vaginal morcellation|patients will be randomized to receive vaginal morcellation
16025033|NCT02703233|Drug|Nitrous Oxide|
16025034|NCT02703233|Other|Oxygen|
16025035|NCT02703220|Other|Hyperoxia/oxygen|The ventilatory effects of brief hyperoxia will be assessed by analyzing control breaths on room air immediately preceding the hyperoxic exposure, and comparing with the primary end-point, nadir minute ventilation breath, immediately following the brief hyperoxic exposure
16025036|NCT02703220|Drug|Acetazolamide|Participants with sleep apnea will ingest capsules containing either placebo or acetazolamide 500 mg twice a day for 5 days. On the final 2 consecutive nights while still on ACZ, the investigators will perform i) physiology tests and ii) in-lab follow-up PSG.
16025037|NCT02703220|Drug|Finasteride|Elderly males with sleep apnea and adequate testosterone levels will ingest placebo vs finasteride, at 5 mg a day for 1 month (mo). After 1 mo, while still on the drug, on the final 2 consecutive nights, the investigators will perform i) physiology tests and ii) in-lab follow-up PSG. Blood tests will be performed to check sex hormone levels. A washout period of 1 month prior to cross-over to the alternate arm (placebo).
16025038|NCT02703207|Device|Positive airway pressure|CPAP will be applied as standard of care for diagnosis of moderate to severe OSA
16025039|NCT02703207|Device|NIPPV and /or oxygen|supplemental oxygen will be applied to PAP/non-invasive positive pressure therapy
16025040|NCT02703194|Drug|Prednisone|Prednisone:A starting dose of 0. 5-0. 8mg/(kg*d) will be given. Following four-week period, the dose will be tapered gradually to 5mg/d until the end of 12 months of follow-up period.
16025041|NCT02703194|Drug|Leflunomide|Leflunomide:A starting dose of 20 mg/day will be given. This dose may be decreased to 10 mg/day at the discretion of the treating physician if minor adverse effects occur(e.g., liver enzyme elevations).
16025042|NCT02703181|Drug|Epelsiban (GSK557296)|White to off-white 0.270 inches x 0.700 inches oblong film coated tablet containing 25 mg or 100 mg epelsiban. To be swallowed whole with water, not to be chewed.
16025043|NCT02703181|Drug|Placebo to match GSK557296|White to off-white 0.270 inches x 0.700 inches oblong film coated Tablet containing placebo. To be swallowed whole with water, not to be chewed.
16025044|NCT02703155|Device|Home Oral Glucose Tolerance Test kit|Providing Home Oral glucose tolerance test kit to children with Cystic fibrosis for screening Cystic Fibrosis Related Diabetes
16025045|NCT02703142|Procedure|Patients after esophagectomy|postoperative endoscopic evaluation
16025046|NCT02703129|Other|Nutritional intervention|Women with the diagnosis of migraine received individualized diet meal plan and nutritional orientations for three months according to their nutritional diagnosis
16025047|NCT02703116|Behavioral|Alcohol Use BI|Those who are randomized to the intervention will complete eSBI, an electronic brief intervention for substance use, which is comprised of 11 topical areas, each with a single webpage, in a motivational interviewing (MI) format. MI is a client-centered behavioral change approach.
16025048|NCT02703116|Behavioral|Nutrition Intervention|Those randomized to the control will complete the attention control modules, a non-active brief time-matched attention control intervention of equal length (i.e., encouraging nutrition).
16122922|NCT01988779|Drug|oral levofloxacin|
16025054|NCT02703077|Procedure|Balloon dilation of the papilla|Using a hidrostatic balloon the major papilla will be dilated to facilitate the stone removal
16025055|NCT02703077|Procedure|EHL (electrohydraulic lithotripsy)|With a probe a direct view lithotripsy will be performed
16025056|NCT02703077|Procedure|ERCP (Endoscopic retrograde cholangiopancreatography)|Endoscopic procedure to identify and treat biliary diseases
16025057|NCT02703064|Dietary Supplement|Furocyst|Furocyst caps BD
16025058|NCT02703051|Drug|GMI-1271|
16025059|NCT02703051|Drug|Filgrastim|
16025060|NCT02703051|Drug|Placebo Injection|
16025061|NCT02703051|Drug|Placebo Infusion|
16025062|NCT02703025|Dietary Supplement|GCB-70|green coffee bean extract
16025063|NCT02703012|Other|Adjustment of ventilator settings by EIT|Diagnostic maneuvers (change in tidal volume, recruitment maneuvers) will be performed to detect overdistention, tidal recruitment and recruitability. Tidal volume will be reduced if overdistention is detected by EIT. Positive end-expiratory pressure will be increased if tidal recruitment or recruitability are detected.
16025064|NCT02702999|Device|Clinically-indicated ultrasound|Routine third trimester care with clinically-indicated ultrasound (control)
16025065|NCT02702999|Device|Serial third trimester ultrasound|Ultrasound evaluation for fetal growth and amniotic fluid will be performed every 4 weeks starting at 30 weeks (intervention group). Thus, if they continue to term, there will be 3 additional ultrasounds exams (30, 34 and 38 weeks).
16025066|NCT02702986|Procedure|immunostimulating Interstitial Laser Thermotherapy|Through a laparotomy a laser device will be inserted into the locally advanced pancreatic cancer.
16025067|NCT02702986|Device|Laser|
16025068|NCT02702973|Other|Observe the fundus characteristics after therapy.|
16025069|NCT02702960|Procedure|living related donor partial liver transplantation|HLA matched or haploidentical related living donor partial liver transplant followed by tacrolimus, prednisone, and MMF immunosuppression for >3 wks
16025070|NCT02702960|Radiation|Total body irradiation|200 cGy total body irradiation (TBI) on Day -1.
16025071|NCT02702960|Procedure|Bone marrow transplant from same donor|BMT using cells from the same Human Leukocyte Antigen (HLA)-matched or -haploidentical living related donor will be performed on Day 0
16025072|NCT02702960|Drug|Cyclophosphamide|Pre-transplantation low dose cyclophosphamide given day -6 and -5 Post-transplantation high dose cyclophosphamide (PTCy; 50 mg/kg/day) will be administered on Days 3 and 4 with hydration
16025073|NCT02702960|Drug|Mesna|administered on Days 3 and 4 with PTCy
16025074|NCT02702960|Drug|Filgrastim|administered daily starting on Day 5 until absolute neutrophil count (ANC) recovery
16025075|NCT02702960|Drug|Tacrolimus|Given after liver transplant for through day -7, stopped on day -6 and restarted on day 5 post BMT
16025076|NCT02702960|Drug|mycophenolate mofetil|Given after liver transplant for through day -7, stopped on day -6 and restarted on day 5 post BMT
16025077|NCT02702960|Drug|Prednisone|Given after liver transplant for through day -7, stopped on day -6 and restarted on day 5 post BMT
16025078|NCT02702960|Drug|Antithymocyte globulin|Given from Day -16 to Day -14 prior to bone marrow transplantation on day 0
16025079|NCT02702960|Drug|fludarabine|fludarabine given from Days -6 to Day -2 before BMT
16025080|NCT02702947|Dietary Supplement|Prunus domestica extract|Prosman 1 capsule twice a day
16025081|NCT02702934|Other|Test meal|Participants received in random order a test meal (900Kcal, 100g carbohydrates) containing rusks prepared with amylose-rich wheat flour or conventional flour. Blood samples were collected at fasting and every 30 minutes over 4 hours. Breath hydrogen was evaluated as a marker of intestinal fermentation. Participants underwent Visual Analogue Scale to assess subjective appetite sensations.
16025082|NCT02702921|Device|Surgeon's 'standard of care' stapler|
16025083|NCT02702921|Device|Ethicon Powered Vascular Stapler|
16025084|NCT02702895|Behavioral|In-depth Interview (IDIs) or Focus Group Discussion (FGD)|
16025085|NCT02702882|Dietary Supplement|Fenugreek Seeds Extract|Furosap one caps OD
16025086|NCT02702869|Procedure|cleft lip repair|
16025087|NCT02702869|Procedure|cleft palate repair|
16025088|NCT02702869|Procedure|oronasal fistula repair|
16025089|NCT02702869|Procedure|pharyngoplasty|
16025090|NCT02702869|Procedure|gingivoperiosteoplasty|
16025091|NCT02702869|Procedure|LeFort-1 maxillary repositioning|
16025092|NCT02702869|Procedure|rhinoplasty|
16025093|NCT02702869|Procedure|myringotomy and tympanostomy tube placement|
16025094|NCT02702869|Other|speech therapy|
16025095|NCT02702869|Procedure|orthodontia|
16025096|NCT02702869|Procedure|presurgical orthopedics|
16025097|NCT02702869|Device|sound amplification for hearing|
16025098|NCT02702856|Other|ExoIntelliScore Prostate|
16025099|NCT02702843|Procedure|Laparoscopic cholecystectomy with Xenon light|Standard laparoscopic cholecystectomy with white light
16025100|NCT02702843|Procedure|Laparoscopic cholecystectomy (fluorescent cholangiography)|Laparoscopic cholecystectomy in infrared light after injection of indocyanine green pre-operatively.
16025101|NCT02702830|Other|Cardiopulmonary Exercise Testing|Undergo CPET
16025102|NCT02702830|Device|Magnetic Resonance Imaging|Undergo MRI
16025103|NCT02702817|Drug|Naproxen|pale blue oval tablets
16025104|NCT02702817|Drug|Placebo|pale blue oval tablets with no active ingredients, identical in appearance to naproxen intervention
16025105|NCT02702804|Other|High Intensity Interval Training|High Intensity Interval Training
16025106|NCT02702791|Behavioral|Telecoaching|Pedeometer based goals and telecoaching support
16025107|NCT02702791|Other|pulmonary rehabilitation|Conventional pulmonary rehabilitation along the ATS-ERS guidelines, total duration 6 months.
16025108|NCT02702778|Drug|Delayed-Release (DR) Prednisone|delayed release prednisone
16025109|NCT02702778|Drug|Immediate Release (IR) Prednisone|standard prednisone
16025110|NCT02702765|Procedure|Fibroscan|Liver fibrosis will be determined using fibroscan, and reported as changes in the amount of fibrosis in the liver. The fibroscan is a non-invasive procedure
16025111|NCT02702765|Procedure|Ultrasound|Ultrasound is a non-invasive procedure
16025203|NCT02702128|Drug|saline solution|30mL of saline solution on 1 hour and 30mL of saline solution on 8 hours
16026698|NCT02690961|Drug|placebo multiple doses|
16025112|NCT02702765|Drug|Galactose|"Galactose elimination capacity is performed to evaluate metabolic liver function.
~The metabolic liver function test galactose elimination capacity requires a 6-hour fast, the infusion of galactose, blood sampling from the ear lobe, and collection of urine for 4 hours."
16025113|NCT02702765|Procedure|Liver biopsy|Histological disease activity at time of diagnosis evaluating if any liver fibrosis
16025114|NCT02702765|Procedure|Functional hepatic nitrogen clearance|Functional hepatic nitrogen clearance to evaluate metabolic liver function Functional hepatic nitrogen clearance requires a 12-hour fast, two venflons, the infusion of alanine, and urine sampling for 4 hours
16025115|NCT02702752|Other|DYNASDY|Measurement of SDF-1 alpha levels i patients' blood samples.
16025116|NCT02702739|Drug|Sofosbuvir 400mg/day/Simeprevir 150mg/day /Ribavirin 800mg/day for 12 weeks|Sofosbuvir 400 mg/day/Simeprevir 150 mg/day /Ribavirin 800/day for 12 weeks
16025117|NCT02702726|Other|Congee and juice with coconut gel|25g coconut oleogel
16025118|NCT02702726|Other|Congee and juice with coconut oil|25g coconut oil
16025119|NCT02702726|Other|Congee and juice with sunflower gel|25g sunflower oleogel
16025120|NCT02702726|Other|Congee and juice with sunflower oil|25g sunflower oil
16025121|NCT02702713|Dietary Supplement|Dairy BEF|Dairy BEF: Milkshake powder enriched with 250 mg of DHA and 3g beta-glucans
16025122|NCT02702713|Dietary Supplement|Egg BEF|Egg BEF: Frozen pancakes enriched with 250 mg of DHA and 320 mg of anthocyanins
16025123|NCT02702713|Dietary Supplement|Bakery BEF|Bakery BEF: Biscuits enriched with 250 mg of DHA and 320 mg of anthocyanins
16025124|NCT02702713|Dietary Supplement|Bakery placebo|Bakery placebo: Biscuits without enrichment
16025125|NCT02702713|Dietary Supplement|Dairy placebo|Dairy placebo: Milkshake powder without enrichment
16025126|NCT02702713|Dietary Supplement|Egg placebo|Egg placebo: Frozen pancakes without enrichment
16025127|NCT02702700|Drug|Cisplatin, liposomal|Lipoplatin IV 200 mg/m2
16025128|NCT02702700|Drug|Verteporfin|Visudyne® IV 3 mg/m2
16025129|NCT02702700|Device|Device for Intrapleural Visudyne-mediated Low-Dose Photodynamic Therapy with integrated in situ light dosimetry|Intrapleural photo-induction will be realized in the chest cavity with low-dose PDT using Visudyne® 3mg/m2 as photosensitizer, activated by 689 nm laser light with a fluence of 10J/cm2 and a fluence rate of <10mWcm2.
16025132|NCT02702674|Drug|propranolol|propranolol 20 mg given before induction of labor
16025133|NCT02702674|Drug|placebo|starch tablet containing no active drug material given before induction of labor
16025134|NCT02702674|Drug|Oxytocin|intravenous infusion of oxytocin
16025135|NCT02702661|Procedure|Fascia Iliaca Compartment Block (FICB)|Fascia Iliaca Compartment Block
16025136|NCT02702661|Procedure|Local Anaesthetic Infiltration (LAI)|Local Anaesthetic Infiltration (LAI) of the portal tracts
16025137|NCT02702661|Drug|Levobupivacaine|Levobupivacaine 0.125% - 40ml
16025138|NCT02702648|Drug|AC-082|Hard gelatin capsules for oral administration
16025139|NCT02702648|Drug|Placebo|Matched placebo capsules for oral administration
16025140|NCT02702635|Procedure|DCE MRI of the brain|An MRI of the brain including a DCE sequence
16025141|NCT02702622|Other|Provitamin A-biofortified transgenic bananas|
16025142|NCT02702609|Device|easy-graft CLASSIC|easy-graft will be grafted to a single extraction socket to preserve the ridge dimension for future implant placement.
16025143|NCT02702609|Device|FDBA with collagen plug|FDBA will be grafted to a single extraction socket and covered by collagen plug to preserve the ridge dimension for future implant placement.
16025144|NCT02702596|Other|Measurement-Based Integrated Care|Measurement-Based Integrated Care (MBIC) synthesizes the science of integrated health care and incorporates the strategies of measurement-based care. concept of MBIC for the treatment of depression includes: systematic assessment of symptoms, antidepressant treatment side effects and medication adherence and incorporation of a Depression Care Manager (DCM) to track patients and keep them engaged in care using behavioral interventions
16025145|NCT02702596|Behavioral|Depression Education Fotonovela|"Depression education that uses a unique, culturally adapted depression fotonovela titled Secret Feelings developed by Cabassa, Molina and Baron (2012). The fotonovela is a popular comic-book style pamphlet that portrays a dramatic story using photographs and dialogue bubbles, which has become an effective tool for engaging Hispanic audiences and increasing knowledge about specific health issues"
16025146|NCT02702596|Behavioral|Standard Education|The the use of a pamphlet to educate people about depression.
16025147|NCT02702570|Behavioral|CASA|Each participant serves as his/her own control. Measures administered before and after the behavioral intervention.
16025148|NCT02702557|Other|Elastic Band Exercises|
16025149|NCT02702544|Device|CardioScreen 1000 - Haemodynamic Measurement System, Medis|Impedance cardiography (ICG)
16025150|NCT02702544|Device|SCHILLER, BR-102 plus - Ambulatory Blood Pressure Monitoring System|Blood pressure monitoring every 1 min during leg elevation
16025151|NCT02702531|Device|FloShield Defogging and Cleaning System|
16025152|NCT02702518|Drug|rhDNase I|rhDNase I, 0.1% eye drops 4 times a day for 8 weeks
16025153|NCT02702518|Drug|Vehicle|Drug vehicle 4 times a day for 8 weeks
16025154|NCT02702505|Biological|NeoMTA|A new formulation of MTA was developed in which bismuth oxide was omitted
16025155|NCT02702505|Other|ProRoot MTA|Control group
16025156|NCT02702492|Drug|KPT-9274|
16025157|NCT02702492|Drug|Niacin ER|
16025158|NCT02702492|Drug|Nivolumab|
16025159|NCT02702479|Other|High Fructose Corn Syrup|An intervention in which calories from HFCS are substituted isocalorically for sucrose in the diet
16025160|NCT02702479|Other|Sucrose|An intervention in which calories from sucrose are substituted isocalorically for HFCS in the diet
16025161|NCT02702466|Other|SPA Therapy|Immersion bath and shower ( 1 treatment ) Underwater shower with localized massage on the painful area ( 1 treatment ) or equivalent underwater massage Illutations ( 1 treatment ) or equivalent ( poultice ) Mobilization Pool ( 1 care) Education to exercise
16025162|NCT02702453|Behavioral|website|The intervention arm will consist of 12 modules, 8 of which are consistent with the trajectory of prostate cancer and its treatment. Four modules address aspects of the prostate cancer experience that are important for patients and partners as well as providers and are designed to optimize the goal of supporting patients and partners in their sexual recovery.
16025163|NCT02702440|Other|Liquid calories from sugars|
16025164|NCT02702427|Biological|virus-specific T-Cells|infusion
16025165|NCT02702414|Biological|Pembrolizumab|
16025166|NCT02702401|Biological|Pembrolizumab|IV infusion
16025167|NCT02702401|Drug|Placebo|0.90% w/v sodium chloride IV infusion
16025168|NCT02702401|Other|Best Supportive Care|Best supportive care will include pain management and management of other potential complications including ascites per local standards of care.
16025169|NCT02702388|Drug|Lenvatinib|Lenvatinib capsule.
16025170|NCT02702388|Drug|Lenvatinib matching placebo|Lenvatinib matching placebo capsule.
16025171|NCT02702375|Other|Fructose-containing Sugars|
16025172|NCT02702362|Device|transcranial direct current stimulation|anodal transcranial direct current stimulation on the precuneus cortex for the anodal session and sham stimulation (5secondes of tDCS) for the sham session.
16025173|NCT02702349|Other|penicillin test|children are tested for penicillin allergy and then challenged with penicillin P.O.
16025174|NCT02702336|Behavioral|EYTO-kids|To promote healthy lifestyles among young people, through the design and implementation of health promotion activities carried out by adolescents (12-14 years old) to scholars of primary education (8-10 years old), using social marketing and peer-led strategy.
16025175|NCT02702323|Drug|Apatinib|apatinib 500mg/day for 6 weeks began taking 4-7 days after TACE
16025176|NCT02702323|Procedure|TACE|one times every 4-6 weeks.
16025177|NCT02702310|Other|Quality-of-Life Assessment|At initial visit (day 1) - for determination of a baseline quality of life, patients will be given a self-reported questionnaire called the Skindex-29. Following standard of care radiation treatments, at weeks 6 & 12, and every 3 months thereafter, patients will complete the Skindex-29 questionnaire.
16025178|NCT02702310|Other|Objective Grading of Skin Findings|At initial visit (day 1) , using mSWAT the radiation oncologist can follow the patient's treatment response by accurately grading the severity of the patient's skin findings. Following standard of care radiation treatments, at weeks 6 & 12, and every 3 months thereafter, mSWAT will again be determined by physician. Follow-up visits will continue until patient has a change in disease.
16025179|NCT02702297|Other|single arm|Daily monitoring of vaginal fluid IL6 and fetal ECG. Daily maternal monitoring and delivery according to standard operating procedure. Post partum diagnosis of FIRS or EOS by analysing of fetal cord blood IL6 and clinical signs of sepsis. Diagnosis of histologic amniotic infection by histological analysis.
16025180|NCT02702284|Behavioral|Advance Directives|These subject's will have a research assistant (RA) review and walk through the advance directives brochure. The RA will read all of the brochure to the patient and prompt for questions. In addition, a link to an educational video on advance directives. The advance directive link will be either texted or emailed or given in paper per the subject's preference.
16025181|NCT02702284|Behavioral|Advance Directives without assistance|This group of subjects will be provided with the advance directive and then referred to clinic staff for assistance.
16025182|NCT02702271|Device|WATCHMAN FLX|Left atrial appendage closure with WATCHMAN FLX
16025183|NCT02702258|Behavioral|MB-BP|MB-BP (Mindfulness-Based Blood Pressure Reduction) customizes Mindfulness-Based Stress Reduction (MBSR) to participants with prehypertension/hypertension. MB-BP will consist of nine 2.5-hour weekly group sessions and an 7.5-hour one-day session. Some of the unique areas of MB-BP are education on hypertension risk factors, hypertension health effects, and specific mindfulness modules focused on awareness of blood pressure determinants such as diet, physical activity, antihypertensive medication adherence, alcohol consumption, and stress reactivity. Students learn a range of mindfulness skills including body scan exercises, meditation and yoga. Homework consists of practicing skills for ≥45 min/day, 6 days/week.
16025184|NCT02702245|Dietary Supplement|Experimental: Thylakoids 5 g|75 g pure glucose + 5 g chloroplast membranes from spinach leaves in a dried powder.
16025185|NCT02702245|Dietary Supplement|Experimental: Thylakoids 10 g|75 g pure glucose + 10 g chloroplast membranes from spinach leaves in a dried powder.
16025186|NCT02702245|Other|Placebo Comparator: Control|75 g pure glucose.
16025187|NCT02702232|Other|Ultrasonography|Ultrasonography is applied for normal subjects and patients with Parkinson's disease
16025188|NCT02702219|Behavioral|Mobility of the hamstrings muscles|
16025189|NCT02702206|Drug|corticosteroids|under US guidance, 2ml triamcinolone (1ml/10mg), 0.5ml distilled water and 1ml 1% lidocaine
16025190|NCT02702206|Drug|hyaluronic acid|under US guidance, 2.5ml HA (ARTZ, 1% sodium hyaluronate solution, 10mg/mL, molecular weight 0.9x106Da) and 1ml 1% lidocaine
16025191|NCT02702206|Drug|normal saline|under US guidance, 2.5ml normal saline (placebo group). 0.5ml distilled water and 1ml 1% lidocaine
16025192|NCT02702193|Behavioral|SET-R/Healthy Home|SET is a manualized, strength-based,directive and process-oriented family-ecosystemic intervention based on Brief Strategic Family Therapy. Healthy Home is an adaptation of SET to be delivered by nurses as an enhanced, family-strengthening, home-health intervention. Healthy Home is delivered in addition to the usual substance abuse or mental health outpatient services received by the mothers. The time-frame for the intervention is approximately 4 months, with home visits approximately every 2 weeks.
16025193|NCT02702180|Drug|molgramostim|molgramostim nebuliser solution
16025194|NCT02702180|Drug|placebo|placebo nebuliser solution
16025195|NCT02702167|Device|High-frequency rTMS|10 Hz active stimulation, once daily
16025196|NCT02702167|Device|Low-frequency rTMS|1 Hz active stimulation, once daily
16025197|NCT02702167|Device|Sham rTMS|Sham stimulation, once daily
16025198|NCT02702154|Device|High-frequency rTMS|20 Hz active stimulation, twice daily
16025199|NCT02702154|Device|Low-frequency rTMS|1 Hz active stimulation, twice daily
16025200|NCT02702154|Device|Sham rTMS|Sham stimulation, twice daily
16025201|NCT02702141|Drug|SGN-CD19B|Given intravenously Day 1 of 28-day or 42-day cycles
16025202|NCT02702128|Drug|Tranexamic Acid|1g of tranexamic acid on 1 hour and 1g of tranexamic acid on 8 hours
16025773|NCT02698072|Device|Sham dry needling|Sham dry needling DONGBANG-ACUPRIME®
16025205|NCT02702102|Drug|11C-PBR28|Up to 20 millicuries
16025206|NCT02702089|Procedure|Rectal cancer surgery|Rectal cancer resection
16025207|NCT02702076|Drug|Apomorphine|Continuous subcutaneous infusion of apomorphine during waking day
16025208|NCT02702076|Drug|Placebo|Continuous subcutaneous infusion of placebo during waking day
16025209|NCT02702063|Other|passive leg raising test|Patients undergoing routine echocardiography are exposed to a passive leg raising test. Change in SV will be measured by TTE and compared to changes in SV measured by EC.
16025210|NCT02702063|Procedure|right heart catheterisation|CO in patients undergoing routine right heart catheterisation will be measured and compared between 3 methodologies: right heart catheterisation, TTE and EC
16025211|NCT02702063|Other|TTE vs. EC + calibration group|Patients will undergo routine echocardiography. CO and SV will be measured by TTE and compared to measurements obtained from simultaneous EC-measurements.
16025212|NCT02702050|Other|Mechanical stimulation (LPG system; Cellu M6 Integral I)|For the mechanical stimulation group, an additional ten-minute mechanical stimulation will be provided in each of the twelve sessions of convention treatment program. The device produced skin lift through suction via a treatment head with 2 rollers installed. It was a non-invasive technique which aimed to mobilize soft tissues by creating skin folds and stretching the underlying soft tissues while manipulating the treatment head according to protocol.
16025213|NCT02702050|Other|Conventional treatment|Twelve sessions of 40-minute remedial exercises, 5-minute warm up and 5-minute cool down exercises, within a 6-week period (i.e., two sessions per week)
16025214|NCT02702037|Dietary Supplement|oral protein-rich supplement|The older person will be offered an oral protein-rich supplement (125 ml, 18 g protein (24% of RDI), 300 kcal) twice a day in conjunction with two of the four sit-to-stand exercises during 12 weeks (7 days/week).
16025215|NCT02702037|Other|Exercise|The older person will get up from a chair to stand and then sit down again repeatedly at least four times per day, 7 days during 12 weeks
16025216|NCT02702024|Procedure|Double uterine incision technique in uterus preserving surgery for placenta percreta|
16025217|NCT02702011|Drug|empagliflozin medium dose|
16025218|NCT02702011|Drug|empagliflozin low dose|
16025219|NCT02702011|Drug|empagliflozin high dose|
16025220|NCT02702011|Drug|placebo|
16025221|NCT02701998|Behavioral|mHealth-Enhance Physical Activity Intervention|
16025222|NCT02701998|Other|Physical Activity Intervention|
16025223|NCT02701985|Drug|Placebo|Matching-placebo capsules will be administered orally, 2 times a day with food.
16025224|NCT02701985|Drug|RO5459072|RO5459072 at a dose of 100 milligrams (as capsules) will be administered orally, 2 times a day with food.
16025225|NCT02701972|Device|BACE Device|Implanted BACE device
16025226|NCT02701959|Dietary Supplement|High Nitrate Lettuce|The lettuce has been grown with high concentration of nitrogen fertilizer (150ppm) to produce the high of nitrate content in the lettuce, the nitrate content of 50 grams of high nitrate lettuce was (~530 mg nitrate derived).
16025227|NCT02701959|Dietary Supplement|Low Nitrate Lettuce|The lettuce has been grown with low concentration of nitrogen fertilizer (25ppm) to produce the low amount of nitrate in the lettuce, the nitrate content of 50 grams of high nitrate lettuce was (~3 mg nitrate derived).
16025228|NCT02701946|Procedure|Modified Robert Jones bandage|Modified Robert Jones bandage is defined as a three-layers of thick cotton wool and two-layers of elastic bandages. The wool layers are put on firmly and overlapped the previous one by half at each turn. The elastic layers were pulled snugly with more tension distally than proximally. Before wrapping in each turn, the elastic bandage was stretched approximately 2 and 1.5 inches at below and above tibial tuberosity level, respectively. The whole bandage attains a thickness of about two inches and extends above the ankle joint to six inches above the knee joint. Before applying this bandage, the sterile gauze pads were placed over the wound and followed by WebrilTM padding (Covidien, Mansfield, MA, US)
16025229|NCT02701946|Procedure|Non compressive dressing|Non-compressive dressing is made by placing the sterile gauze pads over the wound and covering with the hypoallergenic self-adhesive, non-woven fabric tape.
16025230|NCT02701933|Drug|Ketamine|Racemic ketamine, intravenous, at a concentration of 10mg ketamine per 50ml infusion
16025231|NCT02701933|Drug|Saline|Saline, intravenous infusion
16025232|NCT02701920|Device|HeartLight hat|HeartLight hat will be worn for up to 1 hour.
16025233|NCT02701920|Device|The HeartLight hat with in-built sensor|The HeartLight hat with in-built sensor will be worn.
16025234|NCT02701920|Device|HeartLight|Electronic stethoscope will be used to estimate heart rate with HeartLight sensor/hat
16025235|NCT02701920|Device|HeartLight device|HeartLight sensor/hat will be used with ECG/Pulse oximetry/electronic stethoscope
16025236|NCT02701920|Other|parental feedback|Questionnaire
16025237|NCT02701920|Other|healthcare provider feedback|Questionnaire
16025238|NCT02701907|Other|Blood sampling|
16025239|NCT02701894|Dietary Supplement|Alpha-Linolenic Acid|Meta-Analysis of Randomized Controlled Trials
16025240|NCT02701881|Device|Long stenting using drug-eluting stent (Zilver PTX)|Long stenting by full coverage of long femoropopliteal lesion with Zilver PTX after balloon angioplasty
16025241|NCT02701881|Device|Spot stenting using drug-eluting stent (Zilver PTX)|Spot stenting by coverage of residual stenosis or flow-limiting dissection with Zilver PTX after balloon angioplasty of long femoropopliteal lesion
16025242|NCT02701855|Behavioral|Cognitive tests|"Cognitive tests include:
~The MMSE (Mini Mental State Examination)
~Free and Cued Selective Recall Reminding Test (FCSRT).
~Executive functions (fluencies, TMT A and B, span).
~Tests of verbal fluency (literal and category)
~Digit symbol substitution test or Wechsler adult intelligence scale (W.A.I.S)
~The Clinical Dementia Rating Scale
~The IADL scale evaluates autonomy.
~Geriatric Depression screening Scale (GDS)"
16025243|NCT02701855|Biological|Blood test|A blood test will be performed in order to collect following parameters: Urea, BUN, Creatinine, Potassium, Sodium, hematocrit, hsCRP, NFS, Pq, LDL-C, HDL-C, Triglycerides, Lp(a), Lp-PLA2 as well as fasting glucose, HbA1C and microalbuminuria
16025315|NCT02701387|Device|Megagen AnyRidge dental implant|AnyRidge is an approved dental implant with a knife edge, thin thread design available in various thread widths (depth).
16025244|NCT02701855|Radiation|Brain and aorta RMI|A magnetic resonance imaging exam will be performed at the Neuroimaging Research Center of the Pitié-Salpêtrière Hospital. This exam will be optimized to fit in 30 minutes. Indeed brain 3D T1 and T2 FLAIR imaging lasts 15 minutes while cine and velocity encoded imaging of the aorta lasts 15 minutes.
16025245|NCT02701855|Other|Adaptative optics|"The retina adaptative optic imaging will be performed at the Unité de prevention des maladies cardiovasculaires Pitié Salpetrière Hospital. This exam lasts 10 minutes including patient positioning and imaging."
16025246|NCT02701842|Device|ImPACT Online/Paper Pencil Tests|
16025247|NCT02701842|Device|ImPACT Online|
16025248|NCT02701829|Other|CONTROL- Usual & Customary Health Fair Follow-up|participating drivers may fall into 1 of 2 categories- Regular follow-up, or Urgent Follow-up.
16025249|NCT02701829|Other|Health Fair + TECH [Text Messaging + Home Blood Pressure Monitoring]|all participating drivers receives standard Health Fair services initially falling into 1 of 2 categories-Regular Follow-up or Urgent Follow-up. Additionally all participating drivers will receive Home Blood Pressure Monitors and have the mobile health text messaging intervention.
16025250|NCT02701829|Other|Heal th Fair + TECH [Text Messaging + Home Blood Pressure Monitoring] + Social Network Support (SNS)|all participating drivers receives standard Health Fair services initially falling into 1 of 2 categories-Regular Follow-up or Urgent Follow-up. Additionally all participating drivers will receive Home Blood Pressure Monitors for daily BP self-monitoring and text messaging, and they will receive the social network support intervention including an SNS guide for each SNS.
16025251|NCT02701816|Device|innova stent (Boston scientific)|
16025252|NCT02701803|Device|Parkinson's KinetiGraph™ logger|Logger is recording device which records the movement and acceleration of upper extremity
16025253|NCT02701777|Device|STDP|Paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined time.
16025254|NCT02701777|Other|Training|The participant will be asked to perform exercises using their hands and arms.
16025255|NCT02701777|Device|Sham STDP|Sham or fake paired stimulation will be given to the brain and to a peripheral nerve so that the messages are received at the spinal cord at predetermined times.
16025256|NCT02701764|Drug|Pregabalin|
16025257|NCT02701764|Drug|Placebo|
16025258|NCT02701751|Other|Exercise session|A blood sample and fat biopsy will be obtained before and after the 60 minute moderate exercise session. There is no drug or device intervention in this study.
16025259|NCT02701738|Dietary Supplement|Overeating Protocol|Subjects will ingest 30% more calories per day than their calculated daily energy requirements (~750kcals extra energy intake each day). All subjects will be instructed (and will be guided) to consume a diet containing approximately 50% carbohydrate, 35% fat, and 15% protein.
16025260|NCT02701725|Device|CRI status|Measurement of CRI
16025261|NCT02701712|Radiation|Magnetic resonance - guided radiation therapy (MRgRT)|Use of magnetic resonance (MR) visualization for interventional radiotherapy in cancer patients
16025262|NCT02701699|Biological|18-F-FAZA|All patients enrolled in this study will receive a FAZA PET Scan prior to their first radiation therapy fraction
16025263|NCT02701686|Behavioral|quit immediately (QI)|advise to quit immediately using the AWARD model
16025264|NCT02701686|Behavioral|cut down to quit (CDTQ)|advise to reduce cigarette consumption and quit eventally using the AWARD model
16025265|NCT02701673|Drug|Busulfan|"Busulfan test dose administered by vein on Day -10. Test dose of 32 mg/m2 based on actual body weight. Busulfan pharmacokinetics performed with the test dose and the first dose on Day -8. Doses on Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1."
16025266|NCT02701673|Drug|Caphosol|Caphosol oral rinses 30 mL four times a day used from Day -8.
16025267|NCT02701673|Drug|Glutamine|Oral Glutamine, 15 g swished, gargled and swallowed four times a day starting on Day -8.
16025268|NCT02701673|Drug|Pyridoxine|Pyridoxine 100 mg by vein or mouth three times a day staring on Day -1
16025269|NCT02701673|Drug|Belinostat|Starting dose of Belinostat 100 mg/ m2/day by vein on Day -9 through Day -2.
16025270|NCT02701673|Drug|Azacitidine|Azacitidine 15 mg/m2/day by vein on Day -9 through Day -2.
16025271|NCT02701673|Drug|Gemcitabine|Gemcitabine 75 mg/m2 by vein administered as a loading dose followed by prolonged infusion on Days -8 and -3.
16025272|NCT02701673|Drug|Melphalan|Melphalan 60 mg/m2 by vein on Days -3 and -2.
16025273|NCT02701673|Procedure|Stem Cell Transplant|Stem cell transplant performed on Day 0.
16025274|NCT02701660|Device|electronic medication dispenser (medido)|Automated dispense of medication through an electronic dispenser
16025275|NCT02701647|Device|Repetitive transcranial magnetic stimulation (rTMS)|Repetitive TMS (rTMS) is a painless and non-invasive technique for activation of cerebral cortex based on the principle of electromagnetic induction of an electric field in the brain. rTMS will be delivered to the scalp over the leg area of the bilateral motor cortex by using a Magstim Rapid magnetic stimulator. (Magstim Company, Whitland, UK) and 90 mm double cone coil.
16025276|NCT02701647|Other|Treadmill training|Participants will proceed to 30 minute of treadmill training after rTMS. A safety harness without body weight support will be provided. 80% of participant's over ground maximum walking speed will be halved and used for warm-up. After warming up, walking speed will be increased by 0.2 km/h every 5 minutes. Progression will be given if patients could tolerate the belt speed with appropriate step length and walk with good stability for 5 minutes. Participants will maintain the maximum speed achieved for the rest of the session or adjusted as needed. Positive verbal feedback will be given to encourage large strides and upright posture during training. The participants will be instructed to walk on treadmill without holding onto the handrails if possible. Participants will perform warm up and cool down exercise to minimize training related-injury.
16025277|NCT02701634|Drug|ENTO|Tablets administered orally
16025278|NCT02701634|Drug|Placebo|Tablets administered orally
16025279|NCT02701621|Other|MIRT-AT|Aquatic therapy
16025280|NCT02701621|Other|MIRT|Land-based Therapy
16025281|NCT02701608|Drug|Levofloxacin|levofloxacin 500 mg x1/day (for patients ≤70kg) or levofloxacin 750 mg x1/day (for patients >70kg)
16025282|NCT02701608|Drug|Rifampicin|rifampicin 600mg x1/day (for patients ≤70kg) or rifampicin 900mg x1/day (for patients >70kg)
16025550|NCT02699684|Device|Lotrafilcon B contact lenses|Lotrafilcon B contact lenses packaged with copolymer 845
16123051|NCT01987739|Drug|1000 mg almorexant|
16025283|NCT02701608|Procedure|Conventional IV treatment of staphylococci IE following European guidelines 2015 including cloxacilline, oxacilline,gentamicine,vancomycine,rifampicine|Conventional IV treatment of staphylococci IE following European guidelines 2015 including cloxacilline, oxacilline,gentamicine,vancomycine,rifampicine
16025284|NCT02701595|Drug|Amoxicillin|amoxicillin 1500 mg x3/day (for patients ≤70kg) or 2000 mg x3/day (for patients >70kg)
16025285|NCT02701595|Procedure|Conventional IV treatment of streptococci/enterococci IE following European guidelines 2015 including amoxicillin, gentamicin, amicillin, vancomycin, penicillin G, ceftriaxone, netilmicin|Conventional IV treatment of streptococci/enterococci IE following European guidelines 2015 including amoxicillin, gentamicin, amicillin, vancomycin, penicillin G, ceftriaxone, netilmicin
16025286|NCT02701582|Drug|Phenylephrine|if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) < 13 and Cardiac Index is >=2.2 Phenylephrine is administered
16025287|NCT02701582|Drug|Epinephrine|if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) < 13 and Cardiac Index is < 2.2 Epinephrine is administered
16025288|NCT02701582|Other|Albumin|if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) > = 13, fluids are administered --OR-- if Mean arterial pressure (MAP) is > 65, Stroke volume variation (SVV) > = 13 and Cardiac Index is <2.2 fluids are administered.
16025289|NCT02701582|Other|Voluven|if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) > = 13, fluids are administered --OR-- if Mean arterial pressure (MAP) is > 65, Stroke volume variation (SVV) > = 13 and Cardiac Index is <2.2 fluids are administered.
16025290|NCT02701582|Other|Normal Saline|if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) > = 13, fluids are administered --OR-- if Mean arterial pressure (MAP) is > 65, Stroke volume variation (SVV) > = 13 and Cardiac Index is <2.2 fluids are administered.
16025291|NCT02701582|Other|Packed Red Blood Cells|if Mean arterial pressure (MAP) is < = 65, Stroke volume variation (SVV) > = 13, fluids are administered --OR-- if Mean arterial pressure (MAP) is > 65, Stroke volume variation (SVV) > = 13 and Cardiac Index is <2.2 fluids are administered.
16025292|NCT02701582|Device|FloTrac Monitor|FloTrac monitor is connected for all patients, but only visible to the anesthesiologist for half. Based on a decision tree and the data from monitor, choices of interventions are used.
16025293|NCT02701569|Other|Rebound exercise|Repeated jumping on a mini trampoline was administered
16025294|NCT02701556|Device|Complete MPS|a multi-purpose solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses.
16025295|NCT02701556|Device|NNR06|an experimental solution for disinfecting, cleaning, conditioning, rinsing, protein removal, and storing soft contact lenses including silicone hydrogel lenses.
16025296|NCT02701543|Device|Ranger Drug Eluting Balloon|Percutaneous transluminal angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries
16025297|NCT02701543|Device|In Pact Drug Eluting Balloon|Percutaneous transluminal angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries
16025298|NCT02701530|Behavioral|Targeted smoking cessation|Smoking cessation program developed in cooperation with and aimed at smokers with low education.
16025299|NCT02701517|Drug|Cyclosporine + METHOTREXATE|MTX days +1, +3, +6 and +11 followed by rescue with folinic Ac. All patients receive CSA from day -7.
16025300|NCT02701517|Drug|Cyclosporine + CAMPATH-1H|CAMPATH-1H at a dose of 20 mg / day at 8-hour intravenous infusion on days -8 to -4. All patients will receive CSA from day -7.
16025301|NCT02701491|Dietary Supplement|Ginger|ginger
16025302|NCT02701491|Other|Placebo|Placebo
16025303|NCT02701478|Drug|N2O exposure|The aim of this study is to evaluate the nociceptive response to a standardized forearm electrical stimulus applied to patients under GA, during surgery, at different End-Tidal concentrations of N2O (ET-N2O: 0%-50%-25%-0%), and to see if ANI and NoL indices show less pain when inhaled N2O is higher.
16025304|NCT02701465|Other|Exercise: local high intensity interval exercise|The subjects in this arm will receive four high intensity (80% of peak work rate) four-minute interval exercises for the abduction movement in the plane of the scapula (m. supraspinatus), supervised three times per week. In addition they will perform the exercise program described for the control group.
16025305|NCT02701465|Other|Exercise: best clinical practice|The control group will receive a best clinical practice home-exercise program, with regular follow-ups at the shoulder clinic every other week. The details are described in Granviken et al. (2015).
16025306|NCT02701452|Other|COAGO|blood samples for haemostasis and hormonal data
16025307|NCT02701439|Device|Small membrane filtration|"Following the Ugandan National Tuberculosis and Leprosy Programme (NTLP) guidelines, all enrolled TB suspects will undergo the following standardized evaluation:
~Abbreviated demographic and clinical evaluation
~TB history and evaluation
~Obtain three sputum samples - one early morning sample and two spot samples
~HIV testing (and CD4 if positive)
~Chest radiograph
~Small membrane filtration intervention will be administered to both arms"
16025308|NCT02701426|Behavioral|physical activity and nutritional counseling|The program will last 12 weeks, and will include three workshops on diet of the pregnant and lactating women, and the young child. Physical activity sessions will be offered once a week.
16025309|NCT02701413|Device|ApexM (Stimulation) Device|Vaginal electrical stimulation will be administered via the Apex M Device. During each session, the patient will be supine, place conductive gel on the device, insert the device into the vagina, and inflate it to comfort. Subsequently, the device will be turned on and set to previously determined setting. Stimulation session will last 10 minutes and occur 6 times per week for a total of 12 weeks.
16025310|NCT02701413|Device|Sham Device|A sham Apex M device without electrical stimulation will be used. During each session, the patient will be supine, place conductive gel on the device, insert the device into the vagina, and inflate it to comfort. Subsequently, the device will be turned on and set to previously determined setting. Each session will last 10 minutes and occur 6 times per week for a total of 12 weeks.
16025311|NCT02701400|Biological|Durvalumab|Given IV
16025312|NCT02701400|Radiation|Hypofractionated Radiation Therapy|Undergo hypofractionated radiation therapy
16025313|NCT02701400|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
16025314|NCT02701400|Biological|Tremelimumab|Given IV
16025316|NCT02701387|Device|Megagen EZ Plus dental implant|EZ Plus is an approved dental implant with a standard thread design (width and depth) and that is comparable to many other dental implants currently available on the market.
16025317|NCT02701374|Drug|TRK-700|
16025318|NCT02701374|Drug|Placebo|
16025319|NCT02701361|Behavioral|mobile mindfulness|Receives audiovisual mindfulness content via internet plus call depending on symptoms or request.
16025320|NCT02701361|Behavioral|standard mindfulness|Receives weekly calls from mindfulness expert for 4 weeks.
16025321|NCT02701361|Behavioral|education|Receives web-based content about critical illness topics. Also receives two calls from study team to describe materials and answer questions about materials.
16025322|NCT02701348|Other|Shearwave elastography|Patients with primary breast cancer receiving neoadjuvant letrozole will undergo radiological assessment with digital mammogram, ultrasound (US) including shearwave elastography (SWE). These will be performed at 3 monthly intervals until surgical intervention is considered feasible.
16025323|NCT02701348|Drug|Letrozole|Patients will be receiving neoadjuvant letrozole as standard therapy for breast cancer
16025324|NCT02701348|Procedure|Breast core biopsy|Core biopsies will be taken at diagnosis, and at the time of surgery to allow biological assessment of changes in tumour
16025325|NCT02701348|Other|Magnetic Resonance Imaging|Breast MRI scans will be performed at time of diagnosis and prior to surgery to allow comparison of MRI change and response to treatment
16025326|NCT02701335|Device|Neural mobilization|The first 6 exercises consist of active range of motion movements of the hand designed to improve joint flexibility. The remaining 3 exercises are designed to strengthen grip and pinch by using a non-latex polymer ball: the Thera-Band Hand Exerciser (The Hygenic Corporation, Akron, OH) Subjects began with 10 repetitions the first 4 sessions, progressed to 12 repetitions the next 2 sessions, then 15 (2 sessions), and finally 20, if able, during the last sessions.
16025327|NCT02701335|Device|Gloreha device|Robotic assisted passive mobilization.
16025328|NCT02701335|Device|Standardized exercise|9 exercises: active range of motion, strengthen grip and pinch
16025329|NCT02701322|Behavioral|Medical clown|
16025330|NCT02701309|Device|Non-invasive Iron detection device via Zinc-Protoporphyrin|In this study the feasability, sensitivity and specifity of a non-invasive detection method of zinc-protoporphyrin in children is evaluated. It´s a one-arm study, without control Group. Children are aged between 9m and 5y and have a clinical blood sampling indicated.
16025331|NCT02701296|Drug|Ropivacaine with Epinephrine|Posterior capsular injection - ultrasound guided infiltration of Ropivacaine with Epinephrine between popliteal artery and capsule of knee above the femoral condyles
16025332|NCT02701296|Drug|Ropivacaine|Tibial nerve block - ultrasound selective Ropivacaine tibial nerve block in the popliteal fossa
16025335|NCT02701270|Dietary Supplement|Experimental Dietary Fibre 1|22.17 g of product diluted in 250 ml of water taken once orally.
16025336|NCT02701270|Dietary Supplement|Experimental Dietary Fibre 2|21.84 g of product diluted in 250 ml of water taken once orally.
16025337|NCT02701270|Dietary Supplement|Polydextrose|21.48 g of product diluted in 250 ml of water taken once orally.
16025338|NCT02701270|Dietary Supplement|Dextrose|23.89 g of dextrose diluted in 250 ml of water taken once orally.
16025339|NCT02701257|Device|iPhone bionic pancreas|An experimental device composed of three parts: a continuous glucose monitor, control algorithms running on an iPhone, and drug delivery using Tandem insulin pumps
16025340|NCT02701257|Device|iLet bionic pancreas|An experimental device that combines the functions of the iPhone-based bionic pancreas into one device.
16025341|NCT02701257|Drug|Xeris Xerisol glucagon|A stabilized formulation of human glucagon in a solvent based primarily composed of dimethyl sulfoxide (DMSO) that has prolonged stability and can be used for multiple days in a pump
16025342|NCT02701257|Drug|Lilly glucagon|An aqueous formulation of human glucagon with limited stability that must be changed daily
16025343|NCT02701257|Device|iLet infusion set|The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
16025344|NCT02701257|Device|Contact Detach infusion set|The infusion set sub-study will be studying the experimental iLet infusion set in a cross-over with the Contact Detach infusion set. These visits will be conducted separately from the iPhone and iLet BP visits.
16025345|NCT02701244|Radiation|Permanent Breast Seed Implant (PBSI)|Patients are pre-planned using Computerized Tomography (CT) simulation. Implant is performed after surgery under light sedation and local freezing (alternatively general anesthesia). Stranded seeds are inserted using a brachytherapy template that is immobilized to the planned target volume using a 'localization' needle. Patients are released the same day and Quality Assurance involves post-implant Computerized Tomography (CT).
16025346|NCT02701231|Device|Low-frequency Rotating Magnetic Therapy System|Two pairs of fan-shaped NdFeB permanent magnets were attached to a circular iron plate and arranged to establish magnetic field. The bottom two magnets rotated at certain frequency driven by a step motor, which was controlled using a functional signal generator. The top two magnets rotated synchronously due to the strong magnetic interaction. Magnetic flux density was measured at the target site using a gauss meter. The entire magnetic apparatus was located in a hood with humidity and temperature controller.
16025386|NCT02700997|Device|Vascular Clip|Application of a titanium vascular clip (size small) to the base of each delayed absorbable suture placed at the vaginal apex on the internal vaginal side to help in identification by imaging
16025387|NCT02700984|Device|CyPass Micro-Stent|The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front into the back of the eye. The device is implanted after completion of cataract surgery.
16025388|NCT02700984|Procedure|Cataract Surgery|Cataract surgery involves the removal of the natural lens, which has become clouded (called a cataract), and insertion of an artificial lens (called an intraocular lens). This procedure is done through a small surgical incision in the eye.
16025347|NCT02701231|Drug|Systemic anti-tumor therapy|Systemic anti-tumor therapy includes targeted therapies, chemotherapy and best supportive care, according to NCCN non-small cell lung cancer(NSCLC) and small cell lung cancer(SCLC) guidelines. SCLC patients will receive six cycles of cisplatin and etoposide. NSCLC patients will receive EGFR and ALK test. With sensitive result the first-line therapy will be Erlotinib/Gefitinib/Crizotinib. If insensitive, the patient will receive six cycles of cisplatin and pemetrexed. Then the patient will receive tumor response evaluation. The patient with response or stable disease will receive maintenance therapy with one or some of the drugs including bevacizumab, pemetrexed, gemcitabine and docetaxel until disease progression. During experience all patients will receive clinical observation. Once proven for disease progression the patient will finish the experiment.
16025348|NCT02701231|Device|Sham Low-frequency Rotating Magnetic Therapy System|Sham Low-frequency Rotating Magnetic Therapy System is a similar apparatus except that there were two rotating iron plates instead of magnets, thus lacking a magnetic field.
16025349|NCT02701218|Procedure|Canalith repositioning procedure|Canalith repositioning procedure; single or multiple cycles
16025350|NCT02701205|Biological|etanercept|Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 50mg twice a week by subcutaneous injection for 12 weeks, At the end of the first 12 weeks, all subjects will be treated with Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 50 mg once a week for an additional 12 weeks.
16025351|NCT02701205|Biological|etanercept (half dose)|Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 25mg twice a week by subcutaneous injection for 12 weeks, At the end of the first 12 weeks, all subjects will be treated with Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 50 mg once a week for an additional 12 weeks.
16025352|NCT02701205|Drug|placebo|two vials of placebo twice a week by subcutaneous injection for 12 weeks, At the end of the first 12 weeks, all subjects will be treated with Recombinant Human TNF Receptor-Ig Fusion Protein for Injection 50 mg once a week for an additional 12 weeks.
16025353|NCT02701192|Other|Coccygectomy|Patient receiving coccygectomy surgery.
16025354|NCT02701179|Drug|Lignocaine 1% concentration solution|
16025355|NCT02701179|Drug|Lignocaine 2% concentration solution|
16025356|NCT02701166|Drug|Bezafibrate|bezafibrate 400mg per day
16025357|NCT02701166|Drug|Placebo|placebo 400mg per day
16025358|NCT02701153|Procedure|Conventional Surgery|Undergo surgery
16025359|NCT02701153|Radiation|Hypofractionated Radiation Therapy|Undergo hypofractionated radiation therapy
16025360|NCT02701153|Other|Laboratory Biomarker Analysis|Correlative studies
16025361|NCT02701153|Other|Questionnaire Administration|Ancillary studies
16025362|NCT02701140|Procedure|Coronary stenting|Within 1h after the first PCI, patients will be randomized to either ticagrelor or clopidogrel.
16025363|NCT02701140|Procedure|intracoronary ECG recording|Measurement of ST segment elevation using intracoronary ECG recording
16025364|NCT02701140|Procedure|Coronary Flow reserve|measured with an intracoronary pressure/temperature sensor-tipped guidewire
16025365|NCT02701140|Procedure|Index of Microcirculatory Resistance|measured with an intracoronary pressure/temperature sensor-tipped guidewire
16025366|NCT02701140|Procedure|Fractional Flow Reserve|measurement of Fractional Flow Reserve during hyperemic phase.
16025367|NCT02701127|Drug|Oral niacinamide, 1 gram daily|
16025368|NCT02701127|Drug|Oral niacinamide, 3 gram daily|
16025369|NCT02701127|Drug|Placebo|
16025370|NCT02701114|Procedure|Proximal Adductor Canal Block|Continuous Nerve Block
16025371|NCT02701114|Procedure|Distal Adductor Canal Block|Continuous Nerve Block
16025372|NCT02701101|Device|Use of SEM200 Scanner daily|From enrollment to exit,daily SEM Scanner readings collected on Sacrum and Heels
16025373|NCT02701101|Other|Assessment and treatment of Pressure Ulcers using SOC|Nurse review of Skin risk and skin assessment, notes in chart to assess the frequency to turn patient, use of a specialist bed to prevent or treat early pressure ulcers
16025376|NCT02701075|Device|MC5-A Scrambler Therapy|up to 10 sessions, each session lasting 30 minutes
16025377|NCT02701075|Device|MC5-A Scrambler Therapy Sham Device|up to 10 sessions, each session lasting 30 minutes
16025378|NCT02701062|Device|AtriClip® Gillinov-Cosgrove™ LAA Exclusion Systems|
16025379|NCT02701062|Drug|Warfarin|Anticoagulation Therapy- Standard of Care at the discretion of the Investigator.
16025380|NCT02701049|Other|Methods to collect SO/GI information in the ED|In Mode 1, all patients presenting to the ED will have SO/GI information collected verbally by the nurse, which is standard of care. In Mode 2, all patients presenting to the ED will have SO/GI information collected in a non-verbal manner, in which the registrar will ask them to complete an electronic form.
16025381|NCT02701023|Drug|MitoGel|The patient would then undergo instillation of MitoGel into the affected kidney. The catheter would be left indwelling in the ureter and would be externalized through a urethral catheter. The ureteral and urethral catheters would remain indwelling for the duration of the 6 treatments, which would occur twice weekly for 3 weeks. Following the final instillation, the catheters would be removed. The patient would then undergo ureteroscopic evaluation at 3 months following the final instillation of MitoGel. The total duration of study would be 3 months.
16025382|NCT02701010|Behavioral|Structured training and leaflet|"The patients who were given both explanatory verbal instructions of the educational leaflet on the structured behavioural therapy for iOAB by continence nurse and the educational leaflet were included in this group."
16025383|NCT02701010|Behavioral|Structured training|"The patients who were given only explanatory verbal instructions of the educational leaflet on the structured behavioural therapy by continence nurse were included in this group."
16025384|NCT02701010|Behavioral|Leaflet|"The patients who were given only educational leaflet were included in this group."
16025385|NCT02701010|Behavioral|Control Group|Patients who were given unstructured explanations about continence care by a healthcare worker were included in control group.
16123052|NCT01987739|Drug|20 mg zolpidem|
16025389|NCT02700971|Procedure|Molecular Microscope Diagnostic system|Consented patients with locally advanced or metastatic melanoma with This trial will utilize a Molecular MicroscopeTM diagnostic system (MMDxTM) that combines the molecular and histopathological features of biopsies, plus clinical and laboratory parameters, to create the first Integrated Diagnostic System. This MMDxTM will be utilized to phenotype cutaneous melanoma biopsy samples to detect an immune responsive mRNA signature.
16025390|NCT02700958|Procedure|Remote ischemic preconditioning|Remote ischemic preconditioning is performed with standard blood pressure cuff on upper-arm. RIPC will be started just before the coronarography or angiography. Time between the last inflation cycle and the beginning of the procedure will be less than 60 minutes.
16025391|NCT02700958|Procedure|SHAM Remote ischemic preconditioning|SHAM Remote ischemic preconditioning is performed with standard blood pressure cuff on upper-arm. RIPC-SHAM will be started just before the coronarography or angiography. Time between the last inflation cycle and the beginning of the procedure will be less than 60 minutes
16025392|NCT02700945|Device|Reveal LINQ™ Insertable Cardiac Monitor|The Medtronic Reveal LINQ™ ICM is a programmable device that continuously monitors a patient's ECG (electrocardiogram) and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient activation.
16025393|NCT02700932|Device|PicoWay|solid state laser capable of delivering energy at wavelengths of 1064 nm or 532 nm or wave length of 785±20 nm that was added to the system
16025394|NCT02700919|Drug|BCT197|Capsules will be taken orally with fluids over a 5 day period after randomization
16025395|NCT02700919|Drug|Placebo|Capsules will be taken orally with fluids over a 5 day period after randomization
16025396|NCT02700906|Drug|Corticosteroid|triamcinolone (10mg/ml) 1 ml will be injected to the lateral epicondyle of the affected elbow.
16025397|NCT02700906|Drug|Lidocaine|For lidocain injection, 1ml 1% lidocain will also be peppered on the same area.
16025398|NCT02700893|Drug|atropine+ propofol|Atropine bolus: 20 µg/kg Propofol injected over 60 seconds: 1 mg/kg for infants < 1000g - Renewable once 2.5 mg/kg for infants > 1000G - Possible additional dose of 1 mg/kg
16025399|NCT02700893|Drug|atropine + atracurium + sufentanil|Atropine bolus: 20 µg/kg Atracurium: 0.3 mg/kg- Possible additional dose of 0.1 mg/kg Sufentanil: 0.1 µg/kg for infants < 1000g 0.2 µg/kg for infants > 1000g
16025400|NCT02700880|Device|LifeVest|LifeVest monitors patients for VT/VF, notifies the patient if VT/VF occurs, and instructs them to press response buttons. In unresponsive patients, LifeVest delivers defibrillation therapy.
16025401|NCT02700867|Device|NIO|Intraosseous access device NIO (Defibtech)
16025402|NCT02700854|Other|5% carbon-dioxide inhalation|5% CO2 (36 mmHg) and 95% air gas mixture inhalation, for a maximum of 12 hours or until metabolic acidosis recovery occurs as measured by BE > -5 mmol/L in arterial blood gas samples
16025408|NCT02700828|Drug|Hydrocortisone|4 * 0,5 mg/kg /24 hours (in every 6 hours) iv., during hypothermia treatment (max. 72 hours)
16025409|NCT02700828|Drug|Placebo|4 * 2 ml isotonic sodium chloride solution /24 hours (in every 6 hours) iv., during hypothermia treatment (max. 72 hours)
16025410|NCT02700815|Drug|Diclofenac|
16025411|NCT02700815|Drug|Capsaicin|
16025412|NCT02700815|Drug|Placebo|
16025413|NCT02700802|Other|Feed1st|Feed1st is a unique hospital-based hunger mitigation program that, since 2010, has operated low-cost, self-serve food pantries at Comer Children's Hospital. All parents and caregivers with a hospitalized child have 24/7 free access to these self-serve pantries with the option to eat food in the pantry, carry out as much food as needed, and contribute back to the pantry with food, volunteerism, or other resources. The program also offers free phone/text/email navigation for food support and other basic needs resources. We aim to conduct a 3-arm, randomized comparative effectiveness study to evaluate the impact, versus usual care, of two alternative referral strategies to increase Feed1st program utilization and impact.
16025414|NCT02700789|Procedure|Transvaginal ultrasound scan|The presence of the following structures will be recorded: an intrauterine fluid collection; the double decidual sac sign; yolk sac; and fetal pole.
16025415|NCT02700776|Other|Phlebotomy - Blood sampling for GP88 at MM|Women undergoing a screening mammogram will have a blood sample drawn to look for GP88.
16025416|NCT02700776|Procedure|SOC Tissue biopsy|standard of care tissue biopsy if clinically indicated.
16025417|NCT02700763|Other|[18F]dabrafenib molecular imaging|A [18F]dabrafenib dynamic PET scan of the brain (60 minutes) and static total body PET scan will be performed at baseline.
16025418|NCT02700750|Device|OCT exam|OCT exam
16025419|NCT02700737|Other|Image-based simulation modelling|"The first dataset will include the imaging parameters currently recommended by clinical practice guidelines (referred to as limited dataset)."
16025420|NCT02700737|Other|Imaging parameters currently recommended by clinical practice guidelines|"The second dataset will include an expanded list of parameters, inclusive of information that is available from traditional imaging parameters (as recommended by the guidelines) and simulation modeling (referred to as image-based modelling dataset)."
16025421|NCT02700724|Other|Immediate Surgery|
16025422|NCT02700724|Other|Observation|
16025423|NCT02700724|Procedure|Surveillance Cystoscopy and Urinary Cytology|Cytology and cystoscopy are done at the same time
16025424|NCT02700711|Drug|Methylphenidate|The pharmacodynamic effects of methylphenidate maintenance will be determined during maintenance on placebo and duloxetine.
16025425|NCT02700711|Drug|Placebo|The pharmacodynamic effects of placebo will be determined during maintenance on placebo and duloxetine.
16025426|NCT02700711|Drug|Duloxetine|The pharmacodynamic effects of duloxetine will be determined during maintenance on placebo and methylphenidate
16025427|NCT02700685|Dietary Supplement|Pycnogenol|Dietary supplement, standardised extract of French maritime Pine bark. This group receives a nutritional supplement for a period of 10 weeks.
16025428|NCT02700685|Drug|Methylphenidate|Standard pharmaceutical treatment for ADHD, slow release.
16123053|NCT01987739|Drug|40 mg zolpidem|
16025431|NCT02700659|Other|Cxbladder|Cxbladder is a non invasive UC detection test measuring five messenger RNA (mRNA) biomarkers present at elevated levels in patients presenting with urothelial carcinoma.
16025432|NCT02700646|Behavioral|Developmental recommendations|
16025433|NCT02700646|Behavioral|Standard care|standard care
16025434|NCT02700633|Device|Pacemaker|
16025435|NCT02700620|Behavioral|Internet-delivered CBT|Guided internet treatment
16025436|NCT02700607|Drug|Intravenous Crystalloid|crystalloid is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture
16025437|NCT02700607|Drug|Intravenous HES|HES is administered to maintain stroke volume variation < 15 during volume controlled ventilation (8 ml/kg tidal volume) of O2/air mixture
16025438|NCT02700594|Other|Joint mobilization|"Mobilization and manipulation are manual therapy techniques comprising a continuum of skilled passive movements to the joints and/or related soft tissues that are applied at varying speeds and amplitudes, including a small-amplitude/high- velocity therapeutic movement.16 The term joint mobilization, or nonthrust mobilization, often refers to slow, rhythmic, repetitive passive movements to the patients' tolerance, in voluntary and/or accessory range and graded according to examination findings."
16025439|NCT02700581|Procedure|low PEEP conventional ventilation|
16025440|NCT02700581|Procedure|moderate PEEP conventional ventilation|
16025441|NCT02700581|Procedure|low PEEP protective ventilation|
16025442|NCT02700581|Procedure|moderate PEEP protective ventilation|
16025443|NCT02700568|Drug|axitinib|Initial dose of axitinib: 5 mg orally twice a day. Maintenance dose of axitinib: Increase or decrease dose based on individual safety and tolerability. Dose range of axitinib: 2 to 10 mg twice a day.
16025444|NCT02700542|Other|Integrated Pest Management|One-time, in-home, pest intervention for children with persistent asthma living in homes with parent-reported cockroach and/or mouse infestation.
16025445|NCT02700529|Drug|ubenimex|
16025446|NCT02700529|Other|placebo|
16025447|NCT02700503|Behavioral|Encourage 2.0|Participants will be enrolled in the ENCOURAGE 2.0 family-based diabetes prevention intervention that was designed through our work in Aims 1 and 2 of the study. It is this modified population-level ENCOURAGE 2.0 family-based diabetes prevention intervention that will be studied.
16025448|NCT02700490|Behavioral|Psychotherapy|"Behaviour Therapy or Cognitive Behaviour Therapy which forms service as usual in primary care centres in Indonesia."
16025449|NCT02700477|Dietary Supplement|Fenugreek seeds extract|Fenugreek seed extract 500mg, BD
16025450|NCT02700477|Other|Placebo|Placebo capsule containing Dicalcium Phosphate 500mg, BD
16025451|NCT02700464|Device|Bladder EpiCheck Urine Test|The Bladder EpiCheck test is an in vitro diagnostic device for the detection of DNA methylation patterns in urine that are associated with bladder cancer. It is intended for use as a noninvasive method for monitoring for tumor recurrence in conjunction with cystoscopy inpatients previously diagnosed with bladder cancer
16025452|NCT02700464|Procedure|Cystoscopy and pathology|Routine cystoscopy for bladder cancer recurrence and pathology confirmation for patients with positive cystoscopy
16025453|NCT02700451|Drug|Ketorolac|"Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.
~Age 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed."
16025454|NCT02700451|Drug|Acetaminophen|Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.
16025455|NCT02700451|Drug|Placebo|Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.
16025456|NCT02700438|Drug|Glyceryl trinitrate ointment|Application of 375 mg of ointment to the distal anal canal, every 12 hours for an 8-week period.
16025457|NCT02700438|Procedure|Urgent PC Neuromodulation System®|Subjects underwent one 30-min session of percutaneous posterior tibial nerve stimulation 2 days per week for 8 consecutive weeks in an outpatient clinic, with a Urgent PC Neuromodulation System®. Patients were placed in the supine position without anesthesia. PPTNS was delivered using a needle electrode that was inserted 3-4cm cephalad and 2 cm posterior to the medial malleolus at a 60º angle towards the ankle joint to a depth of approximately 0.5-1cm. Successful placement was confirmed by the presence of electric sensation 5 cm above and below the insertion site or a digital plantar flexion.
16025458|NCT02700425|Device|CRT Pacemaker|Cardiac Resynchronization Therapy (CRT) is the use of a pacemaker with two endocardial leads placed in the right atrium (RA) and right ventricle (RV). The third lead is traditionally placed in a tributary of the coronary sinus (CS) overlying the epicardial surface of the left ventricle (LV). Alternatively, the third lead may be positioned based on mapping of the common His bundle and actively fixed to achieve QRS normalization via direct His bundle capture.
16025459|NCT02700412|Drug|Epidiolex|Epidiolex oral solution (100 mg/mL CBD concentration) with inactive ingredients including anhydrous ethanol, sesame seed oil, strawberry flavor, and sucralose).
16025460|NCT02700399|Device|Erigo® Hocoma|Robotics assisted tilt table, without functional electrical stimulation
16025461|NCT02700399|Device|Traditional tilt table from Rehab-Care|Traditional tilt table
16025462|NCT02700386|Combination Product|Adjuvant Hypofractionated Radiation|Hypofractionation is the delivery of radiotherapy in single daily doses greater than the 180-200 cGy. Hypofractionation, through use of larger doses per fraction and fewer total treatments, is a method of shortening overall treatment time in breast cancer therapy.
16025463|NCT02700373|Drug|PDC-APB|
16025464|NCT02700373|Drug|Placebo|
16025465|NCT02700360|Dietary Supplement|high-fat diet|This trial is conducted as a randomized, open-label, single -dose, crossover, phase I to evaluate the effect of food on the safety, tolerability and pharmacokinetics of EC-18. EC-18 is given at an oral, once daily in condition of empty stomach and a high fat diet(900~1,000 kcal, contains 50~60%lipid).This trial is divided into Part 1(1,000mg dose) and Part 2(500mg dose and 2,000mg dose), 12 subjects are included in each dose and cross-over period is 7 days. After Part 1 study, If primary PK parameters of EC-18 is affected by food and AEs meeting study discontinuation criteria are not reported, Part 2 will proceed in consecutive order with registering new subjects.
16025551|NCT02699684|Device|Hydrogen peroxide-based lens care solution|Commercially-available hydrogen peroxide-based lens care solution for cleaning, disinfecting, and storing silicone hydrogel soft contact lenses
16025466|NCT02700360|Drug|EC-18|This trial is conducted as a randomized, open-label, single -dose, crossover, phase I to evaluate the effect of food on the safety, tolerability and pharmacokinetics of EC-18. EC-18 is given at an oral, once daily in condition of empty stomach and a high fat diet(900~1,000 kcal, contains 50~60%lipid).This trial is divided into Part 1(1,000mg dose) and Part 2(500mg dose and 2,000mg dose), 12 subjects are included in each dose and cross-over period is 7 days. After Part 1 study, If primary PK parameters of EC-18 is affected by food and AEs meeting study discontinuation criteria are not reported, Part 2 will proceed in consecutive order with registering new subjects
16025467|NCT02700347|Drug|Pyrazinamide|
16025468|NCT02700347|Drug|Allopurinol|
16025469|NCT02700334|Drug|Dapagliflozin|10 mg, one per day before breakfast during 12 weeks.
16025470|NCT02700334|Drug|Placebo|one per day before breakfast during 12 weeks.
16025471|NCT02700321|Device|OPTIFLOW/ AIRVO|"Patients randomized in HFNC group will received a four minutes preoxygenation period with Nasal High Flow Therapy (HFT) Optiflow ®/AIRVO® (60 l/mn FIO2 = 1) before orotracheal intubation under laryngoscopy after crash induction."
16025472|NCT02700321|Procedure|STANDARD Face Mask|"Patients randomized in STANDARD Face Mask group will received a four minutes preoxygenation period with a standard face mask (15 l/mn) before orotracheal intubation under laryngoscopy after crash induction."
16025473|NCT02700308|Device|Kyphoplasty|Placement and inflation of balloon prior to cement injection
16025474|NCT02700308|Device|Conventional vertebroplasty|Conventional vertebroplasty
16025475|NCT02700295|Device|Orthokeratology lens|
16025476|NCT02700282|Behavioral|Backpack Carrying|A 12,5% of body weight backpack will be used for each measurement. Lung function will be assessed while carrying a double strap backpack, a mono shoulder backpack and without a backpack.
16025477|NCT02700269|Other|mBEADS|Evaluate approaches using magnetic bead capture, isolation, and surface tension valve transfer of biomarkers to improve the sensitivity of already approved malaria RDTs.
16025478|NCT02700256|Behavioral|survey|All patients will submit a baseline survey following enrollment onto study. After successful completion of the AXR or 24-hour discharge pathway, the consented patient will be contacted by email or telephone for 5 days following discharge from surgery.
16025479|NCT02700243|Behavioral|Fitbit|Participants receive a Fitbit and are followed over the course of one year to determine use and health outcomes.
16025480|NCT02700230|Procedure|Computed Tomography|Undergo CT scan
16025481|NCT02700230|Other|Laboratory Biomarker Analysis|Correlative studies
16025482|NCT02700230|Biological|Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter|Given intratumorally
16025483|NCT02700230|Other|Quality-of-Life Assessment|Ancillary studies
16025484|NCT02700230|Procedure|Single Photon Emission Computed Tomography|Undergo SPECT imaging
16025485|NCT02700217|Procedure|Bupivacaine and Diamorphine|
16025486|NCT02700217|Procedure|Remifentanil, Propofol and Cistracurium|
16025487|NCT02700217|Procedure|Bupivacaine and Rectus Sheath injection|
16025488|NCT02700204|Device|PicoWay 532nm fractional treatment|is a solid state laser capable of delivering energy at dual wavelength of 1064 nm or 532 nm at extremely short durations in the range of 300-900 ps
16025489|NCT02700204|Device|PicoWay 1064nm fractional treatment|is a solid state laser capable of delivering energy at dual wavelength of 1064 nm or 532 nm at extremely short durations in the range of 300-900 ps
16025490|NCT02700191|Device|uCor|
16025491|NCT02700178|Other|Biofeedback|The visual biofeedback will consist of line or shape targets on a screen that the participants will aim to achieve with your movements. The auditory cues will be a tone or multiple tones to alert them when to move and/or when targets have been achieved. During the biofeedback session the study staff may also provide verbal cues and feedback.
16025492|NCT02700165|Device|The ZELTIQ CoolSculpting System|The CoolSculpting device will be used to perform the treatments.
16025493|NCT02700152|Device|UltraShape|Tissue selectivity is achieved by a proprietary knowledge of ultrasound parameters ensuring specific destruction of the fat cells only within the target area. All other types of tissue, such as blood vessels, muscles and peripheral nerves remain intact. There are no thermal effects. Fat cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time
16025494|NCT02700139|Device|Aspheric lens|By using a special asphericity, MyLens is customized for various prescriptions and vision directions based on specific measurements, intended for myopia correction and control
16025495|NCT02700113|Other|No intervention|Intervention is not a part of this study. This is a behavioral phenotyping study of minimally verbal individuals with Autism Spectrum Disorder.
16025496|NCT02700100|Device|Bioabsorbable Pulmonary Valved Conduit (PV-001)|"The Bioabsorbable Pulmonary Valved (PV) Conduit (PV-001) is a polymer-based medical device, with a total length of 8 cm with inner diameters of 16 or 18 mm. The valve itself is formed by three leaflets, incorporated within the conduit wall.
~The PV conduit is used for correction or reconstruction of the Right Ventricular Outflow Tract (RVOT) in patients with any of the following congenital heart malformations:
~Tetralogy of Fallot
~Truncus Arteriosus
~Pulmonary Atresia
~Transposition of Great Arteries with Ventricular Septal Defect (VSD)
~Pulmonary Stenosis in combination with other defects in congenital heart defect (CHD) syndromes
~The PV conduit can also be used for replacement of previously implanted, but dysfunctional, pulmonary homografts or valved conduits."
16025497|NCT02700087|Drug|ranitidine or famotidine|Patients with symptomatic laryngomalacia will receive ranitidine, famotidine, or placebo medications in order to see if these medications help their symptoms to resolve.
16025498|NCT02700087|Drug|Placebo|Patients with symptomatic laryngomalacia who meet inclusion criteria will be randomized to receive placebo, ranitidine or famotidine, in order to see if these medications help their symptoms to resolve.
16025499|NCT02700074|Other|No Intervention|Intervention is not a part of this study.
16025500|NCT02700061|Procedure|Robotic occupational therapy|Robotic Occupational Therapy three times a week for twelve weeks.
16025501|NCT02700061|Procedure|Induced Constraint Therapy - ICT|Standard Occupational Therapy two times a week for ten weeks, followed by two whole weeks of Induced Constraint Therapy.
16025502|NCT02700048|Drug|intra-nasal naloxone|3 doses of intra-nasal naloxone (4 mg each) will be given during controlled hypoglycemic insulin clamps
16025503|NCT02700048|Drug|Intra-nasal saline|3 doses of intra-nasal saline will be given during controlled hypoglycemic insulin clamps
16025504|NCT02700035|Other|Bii-Zin-Da-De-Dah (Listening to One Another)|Bii-Zin-Da-De-Dah (Listening to One Another) is a family-centered alcohol and drug prevention program for Anishinabe communities. It was the first American Indian adaptation of the Iowa Strengthening Families Program (now called the Strengthening Families Program). This program has been developed and adapted in partnership with multiple Anishinabe communities over a span of 13 years. Bii-Zin-Da-De-Dah has been enormously popular in communities. It is currently the center piece of a National Canadian Mental Health Promotion Program funded by the Public Health Agency of Canada. Now in its third Phase, focusing on national scale-up among first nations people, it has been adapted for eight cultures and translated into French in a recent implementation in Canada.
16025505|NCT02700022|Drug|Alisertib|Dose escalation of alisertib: level 1 - 20 mg, level 2 - 30 mg, level 3 - 40 mg PO BID on Days 1-5 of six 21-day cycles, combined with R-EPOCH Rituximab, IV infusion on day 1 of each cycle; Etoposide, IV infusion for 96 hours on days 1, 2, 3, and 4 Doxorubicin, IV infusion for 96 hours on days 1, 2, 3, and 4 Vincristine, IV infusion for 96 hours on days 1, 2, 3, and 4 Cyclophosphamide, IV infusion for 15 minutes on day 5 Prednisone, PO daily on days 1, 2, 3, 4, and 5
16025506|NCT02700009|Behavioral|Computer-assisted CBT (CCBT)|Computer-assisted psychotherapy for depression using a computer program plus clinician support
16025507|NCT02700009|Other|Treatment as Usual (TAU)|Ordinary treatment for depression in primary care setting
16025508|NCT02699996|Other|Questionnaire Administration|Complete interview
16025509|NCT02699996|Behavioral|Telephone-Based Intervention|Complete the self management + peer mentoring intervention with videoconferencing
16025510|NCT02699983|Behavioral|Behavioral Dietary Intervention|Use SparkPeople web-based program
16025511|NCT02699983|Behavioral|Exercise Intervention|Use Fitbit monitor and SparkPeople web-based program
16025512|NCT02699983|Device|Activity Monitoring Device|Wear Fitbit activity monitoring device
16025513|NCT02699957|Procedure|Left Atrial Appendage Occlusion|Patients undergoing percutaneous/epicardial intervention for left atrial appendage occlusion.
16025514|NCT02699944|Device|ECG Vest Optimization|As part of a standard and clinically indicated CRT optimization procedure utilize an ECG Vest as one modality for collecting information to determine best device programming.
16025515|NCT02699931|Device|Electric3D|Oral-B 3D with orthodontic head
16025516|NCT02699931|Device|Manual|Oral-B orthodontic
16025517|NCT02699918|Procedure|nocturnal oximetry|nocturnal oximetry for screening of sleep apnea syndrome. Patients with abnormal nocturnal oximetry will be further explored by polysomnography.
16025518|NCT02699905|Other|phlebotomy|phlebotomy
16025519|NCT02699892|Drug|Rituximab|Rituximab will be administered at the discretion of treating physician according to approved label. Protocol does not specify/enforce the criteria for initiation of treatment with rituximab and procedure of the infusion of rituximab.
16025520|NCT02699879|Drug|Pirfenidone|Pirfenidone will be administered according to the physician discretion as part of standard care.
16025521|NCT02699866|Device|BLT Implant Ø 2.9 mm|Placement of Straumann BLT implants Ø 2.9 mm in central and lateral incisors in the mandible and lateral incisors in the maxilla for single tooth replacement followed by prosthetic loading.
16025522|NCT02699853|Other|Questionnaire Administration|Ancillary studies
16025523|NCT02699853|Procedure|Radical Cystectomy|Undergo RRC
16025524|NCT02699853|Procedure|Radical Cystectomy|Undergo ORC
16025525|NCT02699840|Biological|Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine|No vaccine will be provided as part of this study
16025526|NCT02699840|Biological|Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine|No vaccine will be provided as part of this study
16025527|NCT02699840|Biological|Meningococcal (Groups A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine|No vaccine will be provided as part of this study
16025528|NCT02699827|Drug|Levobupivacaine hydrochloride|Patients will receive epidural 20 ml levobupivacaine hydrochloride 0.5%
16025529|NCT02699827|Drug|Magnesium sulphate|Patients will receive epidural 5 ml magnesium sulphate 10%
16025530|NCT02699827|Drug|Saline 0.9%|Patients will receive epidural 5 ml saline 0.9%
16025531|NCT02699814|Behavioral|H3 Services|A community-based integrated care model to improve the prevention, early detection and treatment of child mental health problems
16025532|NCT02699801|Drug|propofol|propofol for post-sternal closure sedation
16025533|NCT02699801|Drug|Dexmedetomidine|dexmedetomidine for post-sternal closure sedation
16025534|NCT02699788|Device|Multifunction Cardiogram|
16025535|NCT02699775|Other|Motion Analysis|Motion analysis is used to assess the modifications of gait pattern in chronic spastic stroke patients regularly treated with botulinum toxin injection
16025536|NCT02699762|Other|self rehabilitation of upper limb in experimental group|The patients in the self-rehabilitation group will be taught the self-rehabilitation program by a physiotherapist who is not involved in the patient follow-up. They will receive a log book which will be used to evaluate compliance and tolerance to the program. They will be instructed to carry out the exercises 7 days per week for the whole duration of the study and to record which exercises they carried out and for how long, after each exercise session.
16025537|NCT02699749|Drug|TAK-931|TAK-931 oral capsules.
16025538|NCT02699723|Drug|Arsenic Trioxide|Given PO
16025539|NCT02699723|Drug|Itraconazole|Given PO
16025540|NCT02699723|Other|Laboratory Biomarker Analysis|Correlative studies
16025541|NCT02699710|Drug|Folic Acid|Folic acid will be administered orally as tablet at a single dose of 5 mg.
16025542|NCT02699710|Drug|GDC-0853|GDC-0853 will be administered orally as tablet or capsule at a dose of 200 mg.
16025543|NCT02699710|Drug|Methotrexate|Methotrexate will be administered orally as tablet at a single dose of 7.5 mg.
16025544|NCT02699710|Drug|Rabeprazole|Rabeprazole will be administered orally as tablet at a dose of 20 mg.
16025545|NCT02699697|Radiation|External Beam Radiation Therapy|Undergo EBRT
16025546|NCT02699697|Radiation|Palliative Radiation Therapy|Undergo EBRT
16025547|NCT02699697|Other|Quality-of-Life Assessment|Ancillary studies
16025548|NCT02699697|Other|Questionnaire Administration|Ancillary studies
16025549|NCT02699684|Device|Lotrafilcon B contact lenses with EOBO-41|Lotrafilcon B contact lenses packaged with copolymer 845 and EOBO-41
16025552|NCT02699684|Device|Saline solution for rinsing contact lenses|Commercially-available saline solution used as needed
16025553|NCT02699684|Device|Saline solution for rinsing contact lens case|Commercially-available solution used as needed
16025554|NCT02699671|Device|Bioresorbable Vascular Scaffold|
16025555|NCT02699658|Drug|Levofloxacin|
16025556|NCT02699645|Drug|telmisartan 20mg, amlodipine 2.5mg, and indapamide 1.25mg|1 capsule taken orally once daily for average of 72 months
16025557|NCT02699645|Drug|Placebo|1 capsule taken orally once daily for average of 72 months
16025558|NCT02699619|Device|Pinloc|3 hook pins interlocked in plate.
16025559|NCT02699619|Device|2 Hansson pins|2 isolated hook pins.(Without plate)
16025560|NCT02699606|Drug|Erdafitinib|Participants will receive 8 mg of erdafitinib, once daily with option to up-titrate to 9 mg.
16025561|NCT02699593|Device|Test Contact Lens|
16025562|NCT02699593|Device|Control Contact Lens|
16025563|NCT02699580|Device|lateral rectus recession with biodegradable collagen implant|Exotropia was treated with bilateral lateral rectus recession procedure. Lateral rectus recession was done. After lateral rectus recession, no degradable collagen implant was placed in the area, where lateral rectus was original inserted. One eye was randomly selected for the comparison.
16025564|NCT02699580|Procedure|Lateral rectus recession without biodegradable collagen implantation|Exotropia was treated with bilateral lateral rectus recession procedure. Lateral rectus recession was done in the other eye without placing biodegradable collagen implantation.
16025565|NCT02699567|Other|No intervention|
16025566|NCT02699554|Procedure|Single-event multilevel surgery|
16025567|NCT02699541|Behavioral|Diabetes Self-Management Education|"This study will implement an individualized DSME program based on Information-Motivation-Behavioral (IMB) skills theory. IMB behavioral change theory assumption proposes that health-related behavior information, motivation and behavioural skills are primary determinants of promoting health behavior.
~Researcher will use a previously validated educational toolkit (PRIDE) and will be delivered using motivational interviewing techniques through several sessions for each participant. Two face-to-face sessions (one at the beginning and one at the end of the 3 month period) and one phone call per week or per fortnight."
16025568|NCT02699528|Drug|methylphenidate|The drug will be prescribed as indicated for attention deficit disorder
16025569|NCT02699515|Drug|MSB0011359C|Subjects with metastatic or locally advanced solid tumors will receive intravenous infusion of MSB0011359C over 1 hour once every two weeks for up to 12 months until confirmed progressive disease (PD), unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product (IMP) occurs.
16025570|NCT02699502|Other|matching an appropriate drug therapy to patients with osteoporotic hip fractures|The process involves reviewing patients characteristics virtually and finding the right drug for them while they are still in the hospital. After matching an appropriate drug, getting it through regulatory authorities to the family physician
16025571|NCT02699489|Procedure|Laparoscopic donor nephrectomy|Laparoscopic donor nephrectomy performed via a standard 4-port distribution. Control of the hilar vessels is performed using extra-large Hem-o-Lok clips (Weck- Covidien, Research Triangle Park, NC) and graft extraction is performed via a pre-prepared Pfannenstiel incision
16025572|NCT02699489|Procedure|Open donor nephrectomy|Open donor nephrectomy performed via a supracostal incision above the 11th rib and an extra-pleural extra-peritoneal approach was adopted
16025573|NCT02699476|Behavioral|Psycho-Social Therapy|
16025574|NCT02699476|Device|Cognitive Behavioral Computer Training|
16025575|NCT02699476|Behavioral|Interactive Trainer-Subject Sessions|
16025576|NCT02699476|Device|Active Control Games|
16025577|NCT02699463|Device|Continous Positive Airway Pressure|CPAP refers to the application of positive airway pressure through a mask and tubing to splint a patients throat open at night. CPAP is considered standard treatment for OSA
16025578|NCT02699463|Other|Control Group|Standard sleep hygiene counseling as per published guidelines
16025579|NCT02699450|Drug|Faricimab|Faricimab will be administered by IVT injection in the study eye.
16025580|NCT02699450|Drug|Ranibizumab|Ranibizumab will be administered by IVT injection in the study eye.
16025581|NCT02699437|Other|Testing for antiphospholipid antibodies|Blood samples will be tested for anticardiolipin antibodies and lupus anticoagulant
16025582|NCT02699424|Radiation|External radiation therapy|
16025583|NCT02699411|Device|Dry needling|dry needling Travell and Simons
16025584|NCT02699411|Other|Stability and propioception|Start excursion balance test, WOMAC; ROM, EVA.
16025585|NCT02699398|Behavioral|Domiciliary VR-based motor rehabilitation|3 weeks, 1 to 3 sessions a day, 20min per sessions, of physical therapy using a VR gaming system.
16025586|NCT02699398|Behavioral|Domiciliary occupational therapy for motor rehabilitation|3 weeks, 1 to 3 sessions a day, 20min per sessions, of physical therapy using a VR gaming system.
16025587|NCT02699385|Other|Oral Rehydration Therapy|Each participants will initiate ORT in the physician's office on Day 1.
16025588|NCT02699385|Drug|Domperidone|Each participants will receive Domperidone 0.25 milligram per killogram (mg/kg) of body weight of oral suspension thrice daily for up to 7 days.
16025589|NCT02699385|Drug|Placebo|Each participants will receive placebo oral suspension thrice daily for up to 7 days.
16025590|NCT02699372|Drug|Placebo|
16025591|NCT02699372|Drug|RO6889450|
16025592|NCT02699359|Device|HS-1000 recording|
16025593|NCT02699346|Device|HS-1000 recording|
16025594|NCT02699320|Other|Complications|Not involved
16025595|NCT02699307|Behavioral|Counseling|OT led counseling
16025596|NCT02699294|Other|Manual pressure release|Subjects will be positioned supine on a treatment plinth and will be encouraged to relax as much as possible before pressure is applied. A slow pressure to myofascial latent trigger point will be applied directly over the marked pectoralis minor muscle myofascial latent trigger point site until a moderate but tolerable pain value of 7 out of 10 (0= no pain, 10= severe pain) is reported. Constant pressure will be sustained for 90 seconds if the subjects report that the pain is decreased to a value of 3, the pressure will be increased to restore perceived pain to the value of 7. Then, tissue resistance (barrier) in pectoralis minor muscle will be controlled.
16025672|NCT02698839|Device|BuMA™|Stent platform: stainless steel
16026699|NCT02690948|Biological|Pembrolizumab|Given IV
16025597|NCT02699294|Other|Contract-relax PNF stretch|Subjects will be in a sitting position with hands being clasped behind the head. The pectoralis minor muscle will be passively and slowly stretched until a strong but tolerable stretch discomfort intensity level of 4 out of 10 (0= no pain, 10= severe pain) is reported. Passive stretch will be sustained for 10 seconds followed by 6 seconds of maximal voluntary isometric contraction of the pectoralis minor muscle. Then, subjects will be instructed to relax for further 4 seconds. Subjects will maintain newly active stretched position of pectoralis minor muscle for 10 seconds with a strong but tolerable stretch discomfort intensity level of 4 out of 10. The procedure will be repeated four times with 30 seconds of rest between two successive trials.
16025598|NCT02699294|Other|Z-stretch|Subjects will be positioned supine with knee bent on a treatment plinth, and the legs will be rotated to the opposite direction of the arm to be stretched placing a stabilizing distal tension on the ribs. Then, the subjects will be slowly brought the arm in a circular motion overhead pausing at the points of tightness, maintaining close contact to the treatment table until a strong but tolerable stretch discomfort intensity level of 4 out of 10 (0= no pain, 10= severe pain) is reported. Self-stretch of pectoralis minor muscle, including myofascial latent trigger points will be sustained for 30 seconds. The procedure will be repeated four times with 30 seconds of rest between two successive trials.
16025599|NCT02699281|Drug|ultra-micronized palmitoylethanolamide|ultra-micronized palmitoylethanolamide 600 mg twice a day
16025600|NCT02699281|Drug|Placebo|um-PEA like placebo twice a day
16025601|NCT02699268|Other|Lung function measurement|The infants will be exposed to lung function measurements performed by a new metod (Volusense Pediatrics) and a validated method (EcoMedics Exhalyzer D). The two Methods will be compared. This is not an intervential study, but a study aiming to validate a New Method versus an old method
16025602|NCT02699242|Device|Simulator (ORSIM) training|The simulator/intervention group will undergo training on the virtual reality bronchoscopic simulator (ORSIM) for 60 minutes before the subjects perform the 2nd Fiber optic intubation
16025603|NCT02699216|Device|Electrical Stimulation of the Retina|Transpalpebral micro-current electrical stimulation treatment for 3 consecutive days followed by a short wash-out period of 2 days.
16025604|NCT02699203|Behavioral|High-carbohydrate meal|Participants will consume a high-carbohydrate low fat meal. The macronutrients content will be 55% carbohydrate, 25% protein and 20% fat providing 400-500 kcal. Between interventions there will be at least a 48-hours washout, where participants are encouraged to return to their baseline dietary habits.
16025605|NCT02699203|Behavioral|Low-carbohydrate meal|Participants will consume a low-carbohydrate high fat meal. The macronutrients content will be 10% carbohydrate, 25% protein and 65% fat and will provide 400-500 kcal (matched to the high carbohydrate meal). Between interventions there will be at least a 48-hours washout, where participants are encouraged to return to their baseline dietary habits.
16025606|NCT02699177|Device|CBF measurements|CBF measurements
16025607|NCT02699164|Device|DRX 9000, Axiom Worldwide, Tampa, Florida|non-surgical spinal decompression therapy consist 18 traction cycles. Traction force applied herniation levels according to Magnetic Resonance Imaging (MRI).
16025608|NCT02699164|Other|physiotherapy|electrotherapy was used. electrotherapy consisted of 20 minutes of hot-pack, 20 minutes of TENS and 5 minutes of ultrasound.
16025609|NCT02699164|Other|spinal stabilization exercise|spinal stabilization exercises started elementary exercises. According to patient tolerance, exercise program reestablished.
16025610|NCT02699151|Drug|any drug|Any drug used for the treatment of SVT (e.g. heparin, low-molecular heparin, non-steroidal anti-inflammatory drug, fondaparinux, vitamin K antagonist)
16025611|NCT02699151|Procedure|any procedure/surgery|Any procedure used for the treatment of SVT(e.g. sclerotherapy, endovenous thermotherapy, crossectomy, stripping, thrombectomy, phlebectomy)
16025612|NCT02699151|Other|Any non-pharmacological treatment of SVT|Any non-pharmacological treatment of SVT (including watchful waiting)
16025613|NCT02699138|Drug|Trazodone|100mg of trazodone to be administered orally once.
16025614|NCT02699138|Drug|Placebo|Compounded sugar pill
16025615|NCT02699138|Device|Epiglottic catheter|Catheter that can be placed through the nose to a position behind the tongue to monitor for upper airway obstruction and to measure changes in pressure below the obstruction.
16025616|NCT02699125|Drug|Guanfacine|Guanfacine 1mg for 2 weeks followed by guanfacine 2mg for 4 weeks.
16025617|NCT02699125|Drug|Hydrochlorothiazide|Hydrochlorothiazide 12.5 mg for 2 weeks followed by hydrochlorothiazide 25 mg for 4 weeks
16025618|NCT02699112|Other|Parasternal EMG (EMGpara) and Transthoracic Echocardiography|OHS patients recruited will have EMGpara and Transthoracic Echocardiography at admission and when established on NIV at 3 months.
16025619|NCT02699099|Dietary Supplement|Vitamin A|Oral administration of Vitamin A (1 dose)
16025620|NCT02699099|Biological|Candidate Plasmodium falciparum malaria vaccine|Intramuscular administration of SB257049 vaccine (4 doses)
16025621|NCT02699099|Biological|MR-Vac|Subcutaneous injection of a combined measles and rubella vaccine (1 dose)
16025622|NCT02699099|Biological|Stamaril|Intramuscular injection of a yellow fever (YF) vaccine (1 dose)
16025623|NCT02699086|Drug|PDC-1421 Capsule|PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient.
16025624|NCT02699073|Drug|regorafenib|"160mg once daily during 3 weeks followed by 1 week off therapy.
~Regorafenib will be taken until disease progression according to the CHOI and RECIST1.1 criteria, death or inacceptable toxicity."
16025625|NCT02699060|Procedure|Upper gastrointestinal endoscopy with biopsy and collection of refluxate|The procedure should be performed on an empty stomach standard technique of anesthesia;10% lidocaine solution). The examination includes analysis of esophageal mucosa, expression of inflammatory changes, location, size, number of mucosal defects (erosions, ulcers, strictures, hemorrhages), as well as the appearance of the gastric and duodenal mucosa. . The modified Savary-Miller classification of esophagitis will be used to characterize changes in the esophageal mucosa. For morphological research and monocyte/macrophage phenotype assessment biopsy sampling of distal esophagus will be performed.
16025725|NCT02698449|Procedure|transcranial direct current stimulation sham|the same operation that transcranial direct current stimulating but it is a sham surgery
16025854|NCT02697396|Other|No Text Messaging|Participants in this arm will receive no additional vaccination reminders.
16025855|NCT02697383|Drug|Ixazomib (MLN9708)|
16025626|NCT02699060|Procedure|24-h esophageal pH-impedance test with manometry-control of pH-transducer|"Procedure of pH impedancemetry includes intranasal introduction of a probe into oesophagus and connection of the probe with the recording device and 24-hour wearing of the probe.
~Installation of the probe is carried out on an empty stomach. 24-h pH-impedance monitoring will be done in both distal oesophagus and in the stomach according to standard of practice. Esophageal pH sensor will be positioned 5 cm above the manometrically located border of the lower esophageal sphincter. Measurement with a second pH sensor in the stomach, 10cm below the lower esophageal sphincter in order to monitor intragastric acidity will be done as a standard routine procedure.
~Standard measuring parameters will be collected: percent of time when pH is less than 4, total number of reflux episodes, number of acid and alkaline reflux episodes, duration of longest reflux episode."
16025627|NCT02699047|Dietary Supplement|Encapsuled fish oil|Fish oil extracted from sardine, mackerel and anchovy. Nutritional information per capsule: Kcal: 13; protein: 0.35g; Total Fats: 1.25g; Saturated fat: 0g; polyunsaturated fat: 0.75g; EPA: 0.5g; DHA: 0.25g; Cholesterol: 0g. The supplement was provided in gelatinous capsule with antioxidant (tocopherols).
16025628|NCT02699047|Dietary Supplement|Encapsulated Olive oil|Extra virgin olive oil. Nutritional information per capsule: Kcal: 10; protein: 0.35g; Total Fats: 1g; Saturated fat: 0.1 g; monounsaturated fat: 0.75g; polyunsaturated fat: 0.1g; EPA: 0g; DHA: 0g; oleic acid: 0.65g; Cholesterol: 0g. The supplement was provided in gelatinous capsule without antioxidants.
16025629|NCT02699034|Procedure|ablation for typical atrial flutter|
16025630|NCT02699034|Device|Vision-MR ablation catheter|
16025631|NCT02699008|Drug|Clopidogrel|Antiplatelet agent
16025632|NCT02699008|Drug|Ticagrelor|New P2Y12 receptor inhibitor antiplatelet agent
16025633|NCT02698995|Drug|Dexamethasone|One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation
16025634|NCT02698995|Drug|Ropivacaine|One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation
16025635|NCT02698995|Drug|Paracetamol|After the block regression, at the first analgetic request the patients received the same analgesia protocol
16025636|NCT02698995|Drug|Morphine|After the block regression, at the first analgetic request the patients received the same analgesia protocol
16025637|NCT02698995|Drug|Lidocaine|One hour before surgery the patients received single shot VIB block with the mixture according to the group allocation
16025638|NCT02698982|Device|Depth of anesthesia monitoring (BIS, Covidien USA) and Continus non invasive blood pressure monitoring (Clearsight, Edwards LifeScience, USA)|
16025639|NCT02698982|Procedure|moderate risk surgery|
16025640|NCT02698969|Drug|Sugammadex|
16025641|NCT02698969|Device|Diaphragm Ultrasonography|Prior to induction of anesthesia each enrolled patients, ultrasonography diaphragm evaluation will be performed using an ESAOTE ultrasound machine (ESAOTE MyLab, Genova, Italy) by assessing the TF and amplitude of excursion.
16025642|NCT02698969|Drug|Neostigmine|
16025643|NCT02698969|Drug|Atropine|
16025644|NCT02698969|Device|Neurumuscual monitoring|Neuromuscular monitoring assesses muscle recovery after deep neuromuscular block through trainf of four and post tetanic count method
16025645|NCT02698969|Drug|Rocuronium|Rocuronium will be administered 0.6 mg*kg-1 to reach neuromuscular block at the induction of general anesthesia and 0.15 mg*kg-1 when PTC elicits more than 5 twitches in order to maintain a deep neuromuscular block
16025646|NCT02698969|Drug|Fentanyl|Fentanest will be administered 2 mcg*kg-1 at the induction of general anesthesia and titrated 0.5 mcg*kg-1 every 30 minutes
16025647|NCT02698969|Drug|Propofol|Propofol will be administered 2 mg*kg-1 at the induction of general anesthesia
16025648|NCT02698969|Drug|Sevoflurane|Sevoflurane will be administered at 1.0 MAC in an air/oxygen mixture
16025649|NCT02698956|Device|TAVI (Transcatheter Aortic Valve Implantation)|Edwards SAPIEN 3 Transcatheter Heart Valve (S3 THV) and Edwards Commander Delivery system (transfemoral) and Certitude Delivery system (transapical/transaortic). The Edwards S3 THV is indicated for use in patients with severe, symptomatic, calcific aortic stenosis with STS Score ≥ 8 or Logistic EuroSCORE ≥15
16025650|NCT02698943|Procedure|Phacoemulsification|Phacoemulsification for cataract extraction with Envista MX-60 implantation
16025651|NCT02698930|Drug|dexmedetomidine|Randomly selected patients of the dexmedetomidine group are given intravenous 0.4mcg/kg/h of dexmedetomidine from the beginning of the anesthesia to postoperative 1 day.
16025652|NCT02698930|Drug|Normal saline|Group given intravenous 0.4mcg/kg/h of normal saline from the beginning of the anesthesia to postoperative 1 day.
16025653|NCT02698917|Other|Low normal PaCO2|4.5-4.7 kPa
16025654|NCT02698917|Other|High normal PaCO2|5.8-6.0 kPa
16025655|NCT02698917|Other|Low normal PaO2|10-15 kPa
16025656|NCT02698917|Other|High normal PaO2|20-25 kPa
16025657|NCT02698917|Other|Low normal MAP|65-75 mmHg
16025658|NCT02698917|Other|High normal MAP|80-100 mmHg
16025659|NCT02698904|Behavioral|Guided Relaxation Technique|
16025660|NCT02698904|Other|Documentary Movie|
16025661|NCT02698891|Drug|Paclitaxel|
16025662|NCT02698891|Drug|Neulasta|
16025663|NCT02698891|Drug|Cyclophosphamide|
16025664|NCT02698891|Drug|Doxorubicin|
16025665|NCT02698878|Dietary Supplement|lupin protein|19g of lupin crunchy every day for the whole duration of the intervention phase (60 days)
16025666|NCT02698878|Other|Neuromuscular electrical stimulation|Individual neuromuscular electrical stimulation training had to be performed twice a day (morning and evening) over the whole duration of the intervention phase (60 days). Subjects were asked to continuously increase the intensity until a maximum intensity of 100mA per training.
16025667|NCT02698878|Device|HEPHAISTOS unloading orthotic device|Orthotic device which unloads the muscles of the lower leg. Subjects had to wear the device for the whole duration of the intervention phase (60 days).
16025668|NCT02698865|Device|MONOVISC|Two (2) intra-articular injections of 4 ml MONOVISC, separated by 1 month, delivered under image guidance (ultrasound or fluoroscopy)
16025669|NCT02698865|Device|Saline|Two (2) intra-articular injections of 4 ml saline, separated by 1 month, delivered under image guidance (ultrasound or fluoroscopy)
16025670|NCT02698852|Device|BuMA Supreme|Stent platform: cobalt-chromium alloy
16025671|NCT02698839|Device|BuMA Supreme|Stent platform: cobalt-chromium alloy
16025673|NCT02698826|Other|Protocol for rapid FiO2 optimization|"We plan to test a protocol for FiO2 optimization for mechanically ventilated post-cardiac arrest subjects, with a therapeutic goal of partial pressure of arterial oxygen (PaO2) of 60-99 mmHg, based on the PaO2 range that was associated with the lowest risk of poor outcome in our previously published work. We also use PaO2 (measured by arterial blood gas [ABG] analysis) as the ultimate goal rather than arterial oxygen saturation (SaO2) measured by pulse oximetry because an SaO2 value <100% on pulse oximetry monitoring does not always exclude supranormal PaO2. The protocol in this application begins with very rapid reduction of FiO2 as much as possible according to SaO2 values, and when FiO2 is maximally reduced by SaO2 an ABG is measured, followed by finer adjustment of FiO2 to achieve a PaO2 60-99 mmHg. The protocol not only prescribes each downward titration of FiO2 but it also includes detailed limbs for upward titration of FiO2 to account for potential overshoot in FiO2 reduction."
16025674|NCT02698813|Biological|umbilical cord mesenchymal stem cells and hyaluronic acid|
16025675|NCT02698813|Drug|hyaluronic acid|
16025676|NCT02698800|Device|Blue blocking (BB) lenses|Participants will wear blue blocking lenses each night for 1 week for 2 hours preceding bedtime.
16025677|NCT02698800|Device|Clear lenses|Participants will wear clear lenses each night for 1 week for 2 hours preceding bedtime.
16025678|NCT02698787|Device|Experimental sound coding strategy (FAST)|Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy
16025679|NCT02698787|Device|Commercially available ACE sound coding strategy|Commercially available Cochlear™ Nucleus® CI24RE with Contour Advance™ Electrode or Cochlear™ Nucleus® CI512 cochlear implant with FAST sound coding strategy using crossover design in newly implanted subjects. Both groups will receive the experimental and control strategy
16025680|NCT02698761|Other|Comprehensive Care Plan|"Care Plan
~Patient Controlled Analgesia (PCA). PCA will be initiated and managed at the discretion of the Pain Management team.
~Other Medications. All medications will be given during daytime hours, if possible.
~Pain Psychology.
~Physical Therapy. Patient is expected to spend time out of bed by Day 2 participating in light activity.
~Sleep Hygiene. Patient sleeps between the hours of 10 PM and 5 AM daily. Window blinds open by 8 AM. Patient must be awake and ready to participate in therapy by 9 AM.
~Extracurricular. TV, phone, computer, and video games only between hours of 4-9 PM (computer okay outside of hours only for school work).
~Other. Patient will eat meals during regular daytime hours (e.g. breakfast consumed before 9 am) and shower daily."
16025681|NCT02698748|Drug|Chloroquine|Chloroquine sulphate (Meriquine®; 250mg; 150 mg of chloroquine base; Baroda, India) will be administered at a total dose of 25 mg/kg (expressed as mg of CQ base per kg body weight, once daily during 3 consecutive days, following the schedule 10mg/kg Day 1; 10mg/kg day 2 and 5 mg/kg day 3).
16025682|NCT02698748|Drug|Placebo|Placebo Placebo pills will be standard placebo capsules filled with powder contents with no pharmaceutical activity. They will not be identical to the chloroquine tablets, so the study will not be double blind, but rather single blinded. Placebo tablets will be manufactured by the pharmaceutical department of the Hospital Clínic, in Barcelona, Spain
16025683|NCT02698735|Drug|Gentamicin|Gentamicin was either formulated into a 0.1% ointment or solutions for injection were purchased directly from suppliers.
16025684|NCT02698735|Drug|Placebo|There are two placebos used in this study. The ointment vehicle (same as used to formulate gentamicin) and vehicle solution for injection.
16025685|NCT02698722|Other|End-stage renal disease treatment options|This group will receive the intervention which is a 11.5 minute video about dialysis and non-dialytic therapies.
16025686|NCT02698709|Other|Analysis of anterior and posterior corneal surfaces|Corneal data obtained from a Scheimpflug-based topographer were converted to astigmatic vectors in accordance to the method proposed by Thibos
16025687|NCT02698696|Other|ECo program|
16025688|NCT02698696|Other|CRT program|
16025689|NCT02698696|Other|Supportive psychotherapy|
16025690|NCT02698683|Other|lymphocyte count|lymphocyte count
16025691|NCT02698670|Device|Rhythmia mapping system|A 3-D Cardiac Mapping system
16025692|NCT02698670|Device|IntellaMap Orion mapping catheter|A diagnostic basket mapping catheter
16025693|NCT02698657|Drug|ASP5094|Intravenous (IV)
16025694|NCT02698657|Drug|Placebo|Intravenous (IV)
16025695|NCT02698644|Drug|Isoamyl-2-cyanoacrylate|Isoamyl-2-cyanoacrylate will be injected inside fallopian tube hysteroscopically through ureteric catheter
16025696|NCT02698631|Procedure|Conventional AF ablation|"Conventional AF ablation will be carried out according to the standard procedure. Atrial anatomical MRI information will be integrated into the navigation system. Ablation procedure will be carried out with a Smart Touch® catheter (temperature 45 °C, 40W or 30W for anterior or posterior wall, respectively).
~Both in first and re-do procedures, procedure endpoint will be electrical isolation of all pulmonary veins."
16025697|NCT02698631|Procedure|LGE-MRI guided AF ablation|"Post-processed LGE-MRI will be used to identify left atrial fibrotic patches and lesions surrounding pulmonary veins (re-do procedures). Both MRI atrial anatomical and fibrosis information will be integrated into the navigation system. Ablation procedures will be carried out with a SmartTouch® catheter (temperature 45°C, 40W or 30W for anterior or posterior wall, respectively).
~Procedural end-point for first ablation procedures will be isolation of all pulmonary veins, and encirclement and isolation of all atrial fibrotic areas.
~In re-do procedures, all left atrial fibrosis patches will be encircled and isolated and, for electrically non-isolated pulmonary veins, all anatomical gaps in lesions surrounding pulmonary veins (as identified in LGE-MRI) will be closed."
16025698|NCT02698618|Procedure|Diagnostic|"Pre-PCI and treatment:
~At hospital admission: all consecutive patients referred for coronary angiography in stable ischemic heart disease will undergo a complete physical examination, Electrocardiogram (ECG) and laboratory blood testing including cardiac troponin and kinase mioband. Subjects will be investigated to confirm or diagnose existing diabetic or pre-diabetic status.
~At the time of diagnostic catheterization After informed consent, diabetic or pre-diabetic patients with at least one stenosis with a Fractional Flow Reserve value (FFR) ≤ 0.80 fulfilling all the inclusion/exclusion criteria will be included in the trial.At the same time, a multimodal physiology assessment, including Coronary Flow Reserve (CFR) and Index of Microcirculatory Resistance (IMR) will be measured."
16025772|NCT02698072|Device|Dry needling|Dry needling needle AGUPUNT®
16025856|NCT02697383|Drug|Dexamethasone|
16025699|NCT02698618|Drug|Randomization|Randomization: patients will be randomly assigned (with 1:1 ratio) to receive either Clopidogrel or Ticagrelor before their clinically-indicated Percutaneous Coronary Intervention (PCI). Either a loading dose of Ticagrelor 180mg followed by a dose of 90mg b.i.d. (during 48 hours) or a loading dose of Clopidogrel 600mg followed by a daily dose (during at least 48 hours) of 75mg will be administered according to their randomization. Additionally the groups will be balanced according to obesity prevalence [Body Mass Index (BMI) ≥30 kg/m2] with the implementation of a dedicated randomization list.
16025700|NCT02698618|Procedure|PCI|"Pre-PCI: multimodal physiological evaluation: FFR, CFR, IMR will be repeated
~PCI: For all the patients undergoing PCI, the use of unfractioned heparin (UHF) will be allowed at the time of PCI; UFH be administered with a target on Activated Clotting Time (ACT) of 200-250 s. The PCI procedures will be performed by standard technique using only second generation Drug Eluting Stents (DES). In all cases, balloon pre-dilatation will be performed before stent implantation using a semi-compliant balloon with a diameter lower than a 75% of the distal reference diameter of the vessel to avoid confounders Post-dilation will be performed according to clinical practice although it will be not mandatory.
~Post-PCI: After stent implantation/s, multimodal physiological evaluation will be re-performed (FFR, CFR, IMR)."
16025701|NCT02698605|Device|Usability test study of the MirrorPath|"The study was conducted by research assistants. Each subject received one assessment that last lasted 30 minutes. The subjects were not paid for participation. In that, no randomization or masking were performed. Prior to the experiment part of the study, the subjects provided basic biographical information. We then explained the experimental process and demonstrated the operation of the device.
~A novel rehabilitation device, the MirrorPath, designed for the upper limb rehabilitation of patients with hemiplegic stroke. The MirrorPath that was 1180x440x300mm in size and had a shell was constructed of acrylonitrile butadiene styrene (ABS). The control module featured an on/off switch, a knob for adjusting the speed, and an emergency cutoff switch."
16025702|NCT02698592|Device|CelsiusTMDS® 8 mm catheter|After demonstrating cavo-tricuspidal isthmic dependant atrial flutter with a duodecapolar catheter, ablation with continuous tissue lesion will be performed with CelsiusTMDS® 8 mm catheter, until complete isthmic block is achieved.
16025703|NCT02698592|Device|Thermocool® 3.5 mm catheter of irrigated tip|After demonstrating cavo-tricuspidal isthmic dependant atrial flutter with a duodecapolar catheter, ablation with continuous tissue lesion will be performed with Thermocool® 3.5 mm catheter of irrigated tip, until complete isthmic block is achieved.
16025704|NCT02698592|Device|Thermocool® SF catheter|After demonstrating cavo-tricuspidal isthmic dependant atrial flutter with a duodecapolar catheter, ablation with continuous tissue lesion will be performed with Thermocool® SF catheter, until complete isthmic block is achieved.
16025705|NCT02698579|Genetic|Lenti-D|Vector copy number (VCN) measurement, safety evaluations, disease-specific assessments, and assessments to monitor for long-term complications of autologous transplant.
16025706|NCT02698566|Drug|Ranibizumab|Patients will receive single ITV injection of ranibizumab 0.5 mg delivered via PFS on Day 1.
16025707|NCT02698553|Drug|Bupropion HCl XL tablet 150mg|The 150 mg of tablet will be given to subject once daily orally. Subject will be instructed to swallow whole tablet with 240 ml of water, without crushed, divided or chewed.
16025708|NCT02698553|Drug|Bupropion HCl XL tablet 300mg|The 300 mg of tablet will be given to subject once daily orally. Subject will be instructed to swallow whole tablet with 240 ml of water, without crushed, divided or chewed.
16025709|NCT02698540|Other|Nutritional Supplement|High calorie, high protein peptide based
16025710|NCT02698527|Drug|Non-Buffered Lidocaine|Active comparator
16025711|NCT02698527|Drug|Buffered Lidocaine|Experimental, additIon of Sodium Bicarbonate to Lidocaine
16025712|NCT02698514|Drug|Sevoflurane|Anesthesia was maintained with sevoflurane in patients undergoing standardized nociceptive stimulus (long-lasting tetanic stimulus of the ulnar nerve; 30 s, 50 mA, 50 Hz, square-wave).
16025713|NCT02698514|Drug|Desflurane|Anesthesia was maintained with desflurane in patients undergoing standardized nociceptive stimulus (long-lasting tetanic stimulus of the ulnar nerve; 30 s, 50 mA, 50 Hz, square-wave).
16025714|NCT02698501|Drug|MEDI9929|MEDI9929 700mg (3 doses in total, 4-week intervals), administered intravenously
16025715|NCT02698501|Drug|Placebo|Placebo (3 doses in total, 4-week intervals), administered intravenously
16025716|NCT02698488|Procedure|Morphology|
16025717|NCT02698488|Procedure|Morphology and Mass Spectroscopy|
16025718|NCT02698475|Drug|Ustekinumab 0.75 mg/kg|Participants weighing less than (<) 60 kilograms will receive ustekinumab 0.75 milligram per kilogram (mg/kg) at Weeks 0 and 4 followed by every 12 weeks dosing with the last dose at Week 40. Eligible participants for LTE period will continue to receive ustekinumab 0.75 mg/kg up to Week 248.
16025719|NCT02698475|Drug|Ustekinumab 45 mg|Participants weighing greater than or equal to (>=) 60 kg to less than or equal to (<=) 100 kg will receive ustekinumab 45 mg at Weeks 0 and 4 followed by every 12 weeks dosing with the last dose at Week 40. Eligible participants for LTE period will continue to receive ustekinumab 45 mg up to Week 248.
16025720|NCT02698475|Drug|Ustekinumab 90 mg|Participants weighing >100 kg will receive ustekinumab 90 mg at Weeks 0 and 4 followed by every 12 weeks dosing with the last dose at Week 40. Eligible participants for LTE period will continue to receive ustekinumab 90 mg up to Week 248.
16025721|NCT02698462|Other|Family history questionnaire|All invitees receive an invitation to complete a FIT (FOB-Gold) and a validated, online family history questionnaire. Answers from the questionnaire are compared with the Dutch criteria for referral for genetic testing and/or surveillance colonoscopies for persons at a potential familial risk for CRC. Invitees are invited to perform both tests, but if they only perform one this will be assessed. Participants with a positive FIT (cut-off value 275 ng/ml) and/or a positive family history and a diagnosis of familial CRC by a clinical geneticist will be referred for colonoscopy.
16025722|NCT02698449|Procedure|transcranial direct current stimulation|intensity provided will be 2 milliampere during 20 minutes using 2 electrodes (7x5cm). Anode electrode will be located on the right prefrontal dorsolateral area; cathode electrode will be located on the left supraorbital area.
16025723|NCT02698449|Procedure|Specific cognitive rehabilitation|Specific cognitive rehabilitation will be personalized regarding the cognitive complaint and will include a training part and an ecological part.
16025724|NCT02698449|Procedure|Nonspecific cognitive rehabilitation|Nonspecific cognitive rehabilitation will be focused on representation of body in space.
16123054|NCT01987739|Drug|placebo|
16025726|NCT02698449|Radiation|functional Magnetic Resonance Imaging n-back task|the n-back cognitive task was developed : 3 runs will be provided (0-back, 1-back and 2-back), each will be composed of 8 activation blocks and 8 resting blocks alternatively presented.
16025727|NCT02698436|Device|Acne Mask|The light therapy device contains a combination of red and blue light-emitting diodes. The device is applied once daily, in the evening for a duration of 10 minutes
16025728|NCT02698436|Drug|2.5% Benzoyl Peroxide Treatment|The BPO treatment is applied twice daily, once in the morning and once in the evening
16025729|NCT02698423|Device|Cobas HPV DNA Test|Women will receive a home-sent sample for HPV self-testing
16025730|NCT02698423|Other|Papanicolau test|Women will be invited to come in for a physician-performed Pap test
16025731|NCT02698410|Drug|Lanreotide (Autogel formulation) and Temozolomide|
16025732|NCT02698371|Device|G1-Control: Futurabond®DC-SE (FBDC_SE)|Futurabond®DC (FBDC) adhesive by self-etch (SE) mode bonding in NCCls restorations, was randomly assigned to premolar or molar teeth ensuring that this adhesive/mode is only apllied once in each participant.
16025733|NCT02698371|Device|G2-Control: Futurabond®DC_SE_EE|Futurabond®DC adhesive by self-etch mode with selective enamel etching (FBDC-SE-EE) bonding in NCCls restorations, was randomly assigned to premolar or molar teeth ensuring that this adhesive/mode is only apllied once in each participant.
16025734|NCT02698371|Device|G3: Futurabond® U - ER (FBU_ER)|FuturabondU® (FBU) adhesive by etch-and-rinse (ER) mode, bonding in NCCls restorations, was randomly assigned to premolar or molar teeth ensuring that this adhesive/mode is only apllied once in each participant.
16025735|NCT02698371|Device|G4: Futurabond® U - SE (FBU_SE)|FuturabondU® (FBU) adhesive by self-etch (SE) mode, bonding in NCCls restorations, was randomly assigned to premolar or molar teeth ensuring that this adhesive/mode is only apllied once in each participant.
16025736|NCT02698371|Device|G5: Adhese® Universal - ER (ADU_ER)|Adhese®Universal (ADU) adhesive by etch-and-rinse (ER) mode, bonding in NCCls restorations, was randomly assigned to premolar or molar teeth ensuring that this adhesive/mode is only apllied once in each participant.
16025737|NCT02698371|Device|G6: Adhese® Universal - SE (ADU_SE)|Adhese®Universal (ADU) adhesive by self-etch (SE) mode, bonding in NCCls restorations, was randomly assigned to premolar or molar teeth ensuring that this adhesive/mode is only apllied once in each participant.
16025738|NCT02698358|Device|Epic stent (Boston Scientific)|
16025739|NCT02698345|Device|drug-eluting balloon (In.PACT Admiral, Medtronic)|
16025740|NCT02698332|Device|Algorithm for UTI|The algorithm consists of one sheet of laminated paper with instruction in how to diagnose UTI
16025741|NCT02698319|Behavioral|Copenhagen Triage Algorithm|The Copenhagen Triage Algorithm is a new triage method for faster triage in the ED
16025742|NCT02698306|Drug|Dexamethasone|Dexamethasone
16025743|NCT02698306|Drug|Diclofenac Sodium|Diclofenac Sodium
16025747|NCT02698280|Drug|Bevacizumab|Bevacizumab is administered intravenously at 5mg/kg every 3 weeks.
16025748|NCT02698280|Drug|Nimustine|Nimustine is administered intravenously at 90mg/m^2 to 110mg/m^2 every 6 weeks.
16025749|NCT02698267|Drug|BIIB074|Administered as specified in the treatment arm
16025750|NCT02698267|Drug|Itraconazole|200 mg twice daily [BID] on Day 8 and once daily (QD) from Day 9 to Day 15 inclusive
16025751|NCT02698254|Biological|Bevacizumab|
16025752|NCT02698254|Other|Quality-of-Life Assessment|Ancillary studies
16025753|NCT02698254|Radiation|Radiation Therapy|Undergo radiation therapy with conventional fractionation
16025754|NCT02698241|Device|Diagnostic & Medication Management|Single Arm Study. Subjects will be managed using integrated diagnostics.
16025755|NCT02698228|Drug|Bupivacaine (femoral nerve block)|0.5% bupivacaine
16025756|NCT02698228|Drug|Morphine|Intravenous injection of 0.1mg/kg of morphine
16025757|NCT02698228|Device|Ultrasound|
16025758|NCT02698215|Drug|Varenicline|Varenicline 1 mg twice daily
16025759|NCT02698215|Drug|Varenicline plus Naltrexone|Varenicline 1 mg twice daily plus Naltrexone 50 mg once daily
16025760|NCT02698202|Device|Digital Breast Tomosynthesis|twice screening examination: standard 2D mammography + Digital Breast Tomosynthesis
16025762|NCT02698176|Drug|Birabresib|Administered as an oral capsule in a fasted state
16025763|NCT02698163|Device|Nanodiamond reinforced Gutta Percha|Gutta percha reinforced with 5 nm diameter nanodiamonds 5 wt % (NDGP).
16025764|NCT02698163|Device|Gutta Percha|Gutta percha is a device made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. The gutta percha is softened by heat and inserted into the root canal, where it hardens as it cools. Gutta percha is classified as Class I (general controls).
16025765|NCT02698150|Device|HERMES tablet|Tablet, sensors and wearables for daily collection of clinical data
16025766|NCT02698124|Drug|Decitabine|
16025767|NCT02698111|Drug|Donafenib|donafenib 200mg，bid
16025768|NCT02698098|Drug|Methadone|
16025769|NCT02698085|Other|Actual Diacutaneous Fibrolysis|Diacutaneous Fibrolysis is a non invasive physiotherapeutic technique applied by means of a set of metallic hooks ending a spatula with bevelled edges that help to treat the muscles and conjunctive tissues and trying to improve mobility between mobility between muscle planes.
16025770|NCT02698085|Other|Sham Diacutaneous Fibrolysis|Sham Diacutaneous Fibrolysis is applied at a superficial level. A pinch of skin was held with the thumb of the palpatory hand and the tip of the spatula but without effect in the muscle because no penetrate in deep tissue
16025771|NCT02698072|Other|Therapeutic exercise|20-25 minutes aerobic exercise, 20-25 minutes strength exercise and 10-15 minutes stretch exercise.
16025774|NCT02698059|Device|iNAP® Sleep Therapy System (iNAP)|The iNAP provides pressure gradient within the oral cavity to pull the tongue toward upper palate and the soft palate forward, which aims to maintain better upper airway patency near the pharynx to prevent sleep-disordered breathing.
16025775|NCT02698046|Dietary Supplement|Ferrous sulfate|200mg of ferrous sulfate three times a day for 4 months
16025776|NCT02698046|Dietary Supplement|Placebo starch|200mg of placebo starch three times a day for 4 months
16025777|NCT02698033|Drug|Peanut flour|A Double-blind, placebo-controlled food challenge will consist of two challenges performed on separate days. One challenge will consist of 7 doses of peanut given every 20 minutes in increasing amounts up to a total of 7 grams of whole peanut (4 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
16025778|NCT02698033|Other|Toasted oat flour|A Double-blind, placebo-controlled food challenge will consist of two challenges performed on separate days. One challenge will consist of 7 doses of peanut given every 20 minutes in increasing amounts up to a total of 7 grams of whole peanut (4 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
16025779|NCT02698020|Procedure|Room-air|Provision of room-air
16025780|NCT02698007|Device|Laryngeal Mask Airway (LMA)|Fiberoptic bronchoscopy with the use of LMA
16025781|NCT02697994|Other|Sterile Water|0.1 ml intracutaneous sterile water injections into the skin surrounding the Michaelis rhomboid over the sacral area.
16025782|NCT02697994|Other|Dry Injections|dry injections into the skin surrounding the Michaelis rhomboid over the sacral area.
16025783|NCT02697981|Behavioral|nutrition counseling|nutrition counseling and guidance.
16025784|NCT02697968|Device|Electroacupuncture|
16025785|NCT02697955|Drug|Bupivacaine-epinephrine|50 mg bupivacaine and 50 μg adrenalin
16025786|NCT02697955|Other|Placebo|9 mg sodium chloride pr. ml (0,9 %)
16025787|NCT02697942|Other|cognitive training|The investigators will provide participants with tablets to play brain games through Lumosity.
16025788|NCT02697942|Other|exercise training|The investigators will provide participants with foot peddlers.
16025789|NCT02697929|Drug|sugammadex|
16025790|NCT02697929|Drug|Neostigmine|
16025791|NCT02697916|Drug|aspirin|81mg of aspirin daily vs. 325mg of aspirin daily
16025792|NCT02697903|Dietary Supplement|Natural Pomegranate Juice|Supplements (1500ml) of pomegrenate juice (POMj) were taken three times daily in the 48h which proceed the first tested training sessions (i.e. 250ml × 6 times with 8-h intervals between it). Moreover, during this tested sessions, subject consumed an additional 500ml of POMj. Arm-specific: Experimental: 9 elite weightlifter
16025793|NCT02697903|Dietary Supplement|Placebo Juice|Supplements (1500ml) of Placebo juice (PLA) were taken three times daily in the 48h which proceed the second tested training sessions (i.e. 250ml × 6 times with 8-h intervals between it). Moreover, during this tested sessions, subject consumed an additional 500ml of POMj. Arm-specific: Placebo Comparator: 9 elite weightlifter
16025794|NCT02697890|Device|FDBA (MinerOss®) + Mucograft® seal|Collagen matrix membrane for soft-tissue regeneration
16025795|NCT02697890|Device|FDBA (MinerOss®) + Collagen Sponge (HeliPLUG®)|Standard of Care
16025796|NCT02697877|Drug|Regadenoson|
16025797|NCT02697864|Drug|tafamidis|
16025798|NCT02697851|Drug|Microgynon 30®|
16025799|NCT02697851|Drug|Evotaz®|
16025800|NCT02697838|Drug|Apatinib|Apatinib (850 mg qd p.o.) until disease progression or intolerable toxicity or refused by the patients.
16025801|NCT02697838|Drug|Paclitaxel-based chemotherapeutic regimens|"Paclitaxel-based chemotherapeutic regimens including:
~The POF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by oxaliplatin (85 mg/m2) and Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days.
~The PF regimen consisted of a 3-hour infusion of paclitaxel (135 mg/m2) followed by Calcium Levofolinate (200 mg/m2).Subsequently, a 46-hour infusion of fluorouracil (2400 mg/m2) was administered using an ambulatory pump, repeating the cycle every 14 days.
~Paclitaxel 80mg/m2 d1，d8，d15，repeating the cycle every 28 days
~other paclitaxel-based regimens"
16025802|NCT02697825|Procedure|Schiotz tonometer for Intraocular Pressure|Both Values will be corelated
16025803|NCT02697812|Procedure|slow sternal retraction|the sternal retraction (which always need to be performed for coronary artery bypass graft surgery) will be achieved over 15 min instead of the usual 30 sec
16025804|NCT02697799|Behavioral|High-level recruitment strategy consent form|Patients will be exposed to pre-consent messaging and a consent form that includes supplemental information describing a high-level recruitment strategy
16025805|NCT02697799|Behavioral|Mid-level recruitment strategy consent form|Patients will be exposed to pre-consent messaging and a consent form that includes supplemental information describing a mid-level recruitment strategy
16025806|NCT02697786|Device|Transcranial doppler|Prolonged de airing to decrease the number of MES
16025807|NCT02697773|Other|Placebo|Patient receives one dose of placebo to match tanezumab subcutaneously on Day 1 and one dose of placebo to match tanezumab subcutaneously at Week 8.
16025808|NCT02697773|Biological|Tanezumab 2.5 mg|Patient receives one dose of tanezumab 2.5 mg subcutaneously on Day 1 and one dose of tanezumab 2.5 mg subcutaneously at Week 8.
16025809|NCT02697773|Biological|Tanezumab 2.5mg/5mg|Patient receives one dose of tanezumab 2.5 mg subcutaneously on Day 1 and one dose of tanezumab 5 mg subcutaneously at Week 8.
16025810|NCT02697760|Radiation|thallium-201|Thallium (Tl-201) myocardial single photon emission tomography, dynamic imaging
16025811|NCT02697747|Other|Education|Educational intervention in the use of ultrasound to identify landmarks
16025951|NCT02696837|Other|No Muscle Relaxant|
16025952|NCT02696837|Drug|Rocuronium|
16025814|NCT02697721|Behavioral|Powerful Tools for Caregivers|Powerful Tools for Caregivers is a 6-week psychoeducational program. Each week the caregivers will attend a 90-minute workshop in a group setting. These sessions will be co-led by two trained and certified leaders who follow the scripted program. In addition to providing education about caregiving and the importance of self-care, the classes will help caregivers develop self-care tools to manage personal stress and improve communication skills.
16025815|NCT02697721|Other|Control with delayed intervention|Control with delayed intervention
16025816|NCT02697708|Dietary Supplement|Potassium control diet|No additional potassium.
16025817|NCT02697708|Dietary Supplement|Potassium gluconate diet|1000 mg K from potassium gluconate.
16025818|NCT02697708|Dietary Supplement|Potato Diet|1000 mg K from potatoes.
16025819|NCT02697708|Dietary Supplement|French Fries Diet|1000 mg K from French Fries.
16025820|NCT02697695|Other|Laboratory Examination|Laboratory Examination before, 1 month, 3 month, 6 month and up to 12 month after LSK, LRNYGB, LOLGB
16025821|NCT02697682|Biological|injection with the stromal vascular fraction (SVF) of adipose tissue|Description of the active treatment The active treatment is an intra-articular injection with the stromal vascular fraction (SVF) harvested from the patient's own abdominal subcutaneous fatty tissue. SVF is harvested using the Lipogems system.
16025822|NCT02697669|Other|18F-FDG PET|Imaging
16025823|NCT02697656|Behavioral|IPS|Individualized job support provided by an employment specialist
16025824|NCT02697656|Behavioral|Self-help|Self-help resources on obtaining employment and coping with chronic pain
16025825|NCT02697656|Behavioral|Treatment as usual|Transdisciplinary treatment at the pain clinic. This includes medical, psychological and physiotherapy treatment.
16025826|NCT02697643|Behavioral|BHCDS-based recommendations|
16025827|NCT02697643|Behavioral|Non-tailored recommendations|
16025828|NCT02697630|Drug|Pembrolizumab|200 mg administered intravenously (IV) every third week until progression or unacceptable toxicity for a maximum of 24 months
16025829|NCT02697630|Drug|Entinostat|5 mg by mouth (PO) once weekly until progression or unacceptable toxicity for a maximum of 24 months
16025830|NCT02697617|Drug|Pioglitazone|Pioglitazone
16025831|NCT02697617|Drug|Placebo|Placebo
16025832|NCT02697591|Drug|INCAGN01876|Initial cohort dose of INCAGN01876 monotherapy at the protocol-defined starting dose, with subsequent cohort escalations based on protocol-specific criteria. The recommended dose will be taken forward into expansion cohorts.
16025833|NCT02697565|Behavioral|Healthy Caregivers- Healthy Children Toolkit|The treatment arm will receive the train-the-trainer model (utilizing Quality Counts coaches) to deliver the evidence- based HC2 toolkit.
16025834|NCT02697565|Behavioral|Safety Curriculum|Centers randomized to the control arm will receive an attention control consisting of three visits from 'Safety Sam,' a character and safety curriculum that was fully developed and implemented in phase I of HC2. The same delivery model (train-the-trainers utilizing Quality Counts coaches) will be implemented.
16025835|NCT02697552|Drug|HBI-8000|Oral doses of 30mg, 40mg, 50mg twice weekly [BIW].
16025836|NCT02697539|Other|AmF/SnF2|AmF/SnF2 dentifrice used twice daily for 2 minutes for 12 weeks
16025837|NCT02697539|Other|mHA|microcrystalline zinc-hydroxyapatite (mHA) dentifrice dentifrice used twice daily for 2 minutes for 12 weeks.
16025838|NCT02697526|Other|Terumo|
16025839|NCT02697526|Other|Tensoplast|
16025840|NCT02697513|Behavioral|simple infection management protocol|Implementation of a simple management protocol to improve care of patients with acute infection. Implementation will be assisted by a 1.5-day focused training program.
16025842|NCT02697474|Biological|Euvax B®: Hepatitis B vaccine|0.5 mL, Intramuscular
16025843|NCT02697474|Biological|Euvax B®: Hepatitis B vaccine|0.5 mL, Intramuscular
16025844|NCT02697461|Other|Intrinsic Foot Strengthening|"Intrinsic foot strengthening is a commonly used intervention in clinic used to increase foot stability both in prevention of and in treatment of foot and ankle injury. Subjects allocated to the strengthening program will be educated in commonly used short foot exercises and toe yoga maneuvers that target the intrinsic muscles of the foot. No equipment will be required to perform the exercises."
16025845|NCT02697461|Other|Joint Mobilization|Joint mobilization is a commonly used clinical intervention used to decrease pain and increase joint range of motion. In the treatment groups who present with joint hypomobility, a forefoot inversion maneuver with a dorsally applied pressure in the lateral midfoot and rearfoot stabilized will be applied at the barrier before the physiologic end range of motion. A second mobilization will be performed at the distal segment of the 1st Tarsometatarsal joint. These mobilizations will be performed by a board certified orthopaedic physical therapist with 14-yrs of practice experience. No equipment will be required to perform the joint mobilization.
16025846|NCT02697448|Drug|propofol|Participant receives propofol as anesthetic for cardiac ablation.
16025847|NCT02697448|Drug|sevoflurane|Participant receives sevoflurane as anesthetic for cardiac ablations.
16025848|NCT02697435|Other|Patient-Centered Care|Patient-centered care will be directed by geriatricians who have been trained to assess and treat 11 conditions that commonly affect chronic low back pain. Treatments may involve behavioral components, physical therapy, or medical treatments such as cortisone shots, depending on the patient's needs.
16025849|NCT02697435|Other|Imaging-Directed Care|Imaging-Directed Care will allow patients to follow-up their initial imaging with whatever course they (and/or their doctor) chose, should they chose to follow any course at all.
16025850|NCT02697422|Other|Community-based peer health coach intervention|The focus of the peer health coach intervention will be to deliver brief health messages, discuss goal setting, and action planning around health behavior changes shown to decrease CVD risk (for instance, healthy diet, regular to moderate-intensity physical activity, and quitting smoking).
16025851|NCT02697409|Behavioral|Education Against Tobacco intervention|
16025852|NCT02697396|Behavioral|Assessments|All participants, after consent, will be asked to complete the study contact form and then complete a baseline assessment with the RSA. This baseline assessment will take approximately 5 minutes.
16025853|NCT02697396|Other|Text Message Reminder|Participants randomly assigned to the text messaging group will receive a text message reminding them of their child's vaccination eligibility once a week, starting one week after exposure to the social marketing campaign and time of consent.
16025857|NCT02697370|Drug|Pharmacokinetic based dosage change|Pharmacokinetic based dosing of factor VIII prophylaxis treatment compared to standard prophylactic regimens based on weight.Prophylaxis is prescribed according to routine clinical practice with prophylaxis prescribed on alternate days to maintain predicted target trough of ≥1.5 IU/dL based on sparse blood sampling and Bayesian pharmacokinetic estimation
16025858|NCT02697357|Behavioral|Psychosocial Instruments|
16025859|NCT02697357|Behavioral|Emotion Regulation Therapy for Cancer Caregivers (ERT-C)|
16025860|NCT02697344|Drug|Dexamethasone|Given PO
16025861|NCT02697344|Other|Laboratory Biomarker Analysis|Correlative studies
16025862|NCT02697344|Drug|Lenalidomide|Given PO
16025863|NCT02697344|Other|Pharmacological Study|Correlative studies
16025864|NCT02697344|Drug|R-(-)-Gossypol Acetic Acid|Given PO
16025865|NCT02697331|Drug|Progesterone|"women will receive progesterone vaginal pesarries containing 200mg of progesterone twice daily . it will be used by the patient as one vaginal pessary per vagina twice per day .
~women will be showed how to use tablets . medication will be started at 20 -24 weeks and stopped at 36+6 weeks"
16025866|NCT02697331|Other|Placebo|women will receive placebo pessary twice a day. women will be showed how to use tablets . medication will be started at 20-24 weeks and stopped at 36+6 weeks
16025867|NCT02697318|Drug|Timolol maleate 0.5% ophthalmic solution|
16025868|NCT02697305|Dietary Supplement|IV BCAA|in total dose of 0,4 g/kg in a 2 h intravenous infusion
16025869|NCT02697305|Dietary Supplement|ORAL BCAA|single dose of 0.4g/kg administered over 30s washed down with 500mL of tap water
16025870|NCT02697305|Other|ORAL Placebo|single dose of 0.4 g/kg administered over 30 s washed down with 500mL of tap water
16025871|NCT02697292|Drug|Intravenous Immunoglobulin|GAMUNEX-C is a clear a ready-to-use sterile solution of human immune globulin protein for intravenous administration. Dose will be determined based on ideal wt. with not to exceed 80 grams. Subjects will receive 0.5g/kg daily for 1 day [week 1 day 1], then will receive 1g/kg not exceeding 80 grams daily for 1 day [week 1 day 2]. Then once every 2 weeks subjects will receive 0.6g/kg IVIG for 4 weeks [week 3 and 5] for 2 infusions.
16025872|NCT02697292|Drug|Placebos|Normal Saline is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment. Dose will be determined based on ideal wt. with not to exceed 80 grams. Dose will be determined based on ideal wt. with not to exceed 80 grams. Subjects will receive 0.5g/kg daily for 1 day [week 1 day 1], then will receive 1g/kg not exceeding 80 grams daily for 1 day [week 1 day 2]. Then once every 2 weeks subjects will receive 0.6g/kg for 4 weeks [week 3 and 5] for 2 infusions.
16025873|NCT02697292|Drug|Normal Saline|Normal Saline is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment. Subjects will receive 500 ml normal saline before and after the higher dose infusion of 1g/kg
16025874|NCT02697279|Procedure|Traditional Incision and Drainage.|Control Group- Standard treatment of a simple cutaneous abscess with traditional I&D technique with or without packing utilizing a standard I&D kit.
16025875|NCT02697279|Procedure|Loop drainage|Study Group- Treatment of a simple cutaneous abscess with the loop drainage technique utilizing an standard I&D kit and the cuff of a sterile glove for a loop device.
16025876|NCT02697266|Other|No intervention|This is an observational study.
16025877|NCT02697253|Drug|Exendin 9-39 and Sitagliptin|"Infusion of exendin 9-39 at the rate of 600 pmol/kg/min, infusion time 80 minutes. An average of 18.2mg will be infused in a forearm vein during an oral glucose (30g) preload.
~100mg tablet will be administered at 2200 hours the night before the visit. The day of the visit, the patient will take another 100mg tablet at 0700 hours."
16025878|NCT02697253|Drug|Placebo|"Infusion of 0.9% saline solution (placebo infusion) for 80 minutes. An average of 18.2mg will be infused in a forearm vein during an oral glucose (30g) preload.
~100mg Placebo tablet will be administered at 2200 hours the night before the visit. The day of the visit, the patient will take another 100mg placebo tablet at 0700 hours."
16025879|NCT02697240|Drug|Intravenous citrulline|Intravenous citrulline at a bolus dose of 20 mg/kg over 5 minutes and then continuous at a rate of 7 mg/kg/hour for the next 23 hours for the first 7 participants, and depending on safety and pharmacokinetic profile, increase or decrease the continuous rate to 9 or 5 mg/kg/hour for the next 7 participants.
16025880|NCT02697227|Behavioral|Behavioral Intervention|Receive BATS counseling
16025881|NCT02697227|Other|Laboratory Biomarker Analysis|Correlative studies
16025882|NCT02697227|Drug|Nicotine Patch|Receive nicotine patch
16025883|NCT02697227|Other|Questionnaire Administration|Ancillary studies
16025884|NCT02697227|Behavioral|Smoking Cessation Intervention|Receive standard smoking cessation counseling
16025885|NCT02697214|Device|Fitbit Charge HR|Fitbit Charge HR heart rate monitoring device compared to ECG and Polar H7
16025886|NCT02697214|Device|Apple Watch|Apple Watch heart rate monitoring device compared to ECG and Polar H7
16025887|NCT02697214|Device|Mio Fuse|Mio Fuse heart rate monitoring device compared to ECG and Polar H7
16025888|NCT02697214|Device|Basis Peak|Basis Peak heart rate monitoring device compared to ECG and Polar H7
16025889|NCT02697201|Drug|Intralipid|0.55 ml/kg/h
16025890|NCT02697201|Drug|Saline|0.55 ml/kg/h for
16025891|NCT02697188|Drug|Testosterone undecanoate|Single-day dose as QD or BID for 3 of 5 crossover periods
16025892|NCT02697188|Drug|Testosterone enanthate|Single-day dose for 2 of 5 crossover periods
16025893|NCT02697175|Device|Live Video-Colposcopy|The colposcopy will be shown in real time on a flat screen
16025894|NCT02697175|Other|No Live Video-Colposcopy|The TV will be shut off during colposcopy
16025895|NCT02697162|Device|Antiseptic-coated catheter|Antiseptic-coated hydrophilic intermittent urinary catheter with octenidine chloride
16025896|NCT02697162|Device|Hydrophilic catheter|Hydrophilic intermittent urinary catheter
16025897|NCT02697162|Drug|Octenidine chloride|Antiseptic
16025898|NCT02697149|Radiation|nonradiation-to-endoscopist endoscopic retrograde cholangiopancreatography|All patients received magnetic resonance cholangiopancreatography before the procedure. Characteristics of lesions (e.g. common bile duct stones, stenosis) in detail was identified. During the procedure, the endoscopist was not exposed to radiation. If fluoroscopy was needed, after contrast injection (sometimes not necessary), the endoscopist went outside of the operation room and observed the X-ray image by remote control of the fluoroscopy machine.
16026147|NCT02695433|Dietary Supplement|Active|Active Treatment Diet Plan
16025899|NCT02697149|Radiation|standard endoscopic retrograde cholangiopancreatography|Patients received standard endoscopic retrograde cholangiopancreatography. Fluoroscopy was normally used when necessary.
16025900|NCT02697136|Drug|CER-001|Recombinant human apoA-I/phospholipid complexes
16025901|NCT02697136|Drug|Placebo|0.9% Sodium Chloride Injection, USP
16025902|NCT02697123|Other|antepartum and postpartum|This is a prospective observational cohort study.
16025903|NCT02697110|Behavioral|Edutainment based intervention|Edutainment intervention package
16025904|NCT02697084|Other|anal cancer|Anal cancer patients with TEP TDM
16025905|NCT02697071|Drug|Ketamine|Patients in this arm will receive 0.2mg/kg ketamine intravenously, pain scores will be collected after 30 minutes. At that time rescue medication will also be offered. Pain scores will continued to be recorded until 60 minutes have passed since drug administration.
16025906|NCT02697071|Drug|Normal Saline|Patients will receive normal saline intravenously, pain scores will be collected after 30 minutes. At that time rescue medication will also be offered. Pain scores will continued to be recorded until 60 minutes have passed since drug administration.
16025907|NCT02697058|Biological|BAX2398 + 5-FU/calcium levofolinate|BAX2398 (a liposomal formulation of irinotecan) in combination with 5-FU/calcium levofolinate
16025908|NCT02697058|Drug|5-FU/calcium levofolinate|5-FU/calcium levofolinate alone
16025909|NCT02697045|Drug|Aripiprazole 400mg LAI|Aripiprazole 400mg, IM, Once a month
16025910|NCT02697032|Drug|Bicalutamide|150mg
16025911|NCT02697032|Procedure|FDHT PET|PET scan
16025912|NCT02697019|Behavioral|Internet-delivered Emotion Regulation Individual Therapy for Adolescents|
16025913|NCT02697006|Drug|i-cor Synchronized Cardiac Assist Device|The i-cor Synchronized Cardiac Assist Device delivers pulsatile cardiac assist synchronized to the ECG during diastole and provides enhanced oxygenation through a membrane oxygenator.
16025914|NCT02696993|Procedure|Cognitive Assessment|Ancillary studies
16025915|NCT02696993|Biological|Ipilimumab|Given IV
16025916|NCT02696993|Other|Laboratory Biomarker Analysis|Correlative studies
16025917|NCT02696993|Biological|Nivolumab|Given IV
16025918|NCT02696993|Radiation|Stereotactic Radiosurgery|Undergo SRS
16025919|NCT02696993|Radiation|Whole-Brain Radiotherapy|Undergo WBRT
16025920|NCT02696980|Device|Positive Expiratory Pressure|Patient will exhale against positive expiratory pressure 0 mm or 10 mm while inhaling methacholine
16025921|NCT02696967|Drug|CLR325|CLR325 Concentrate for solution for infusion
16025922|NCT02696967|Other|Placebo|Normal saline
16025923|NCT02696954|Drug|Artemether-lumefantrine|Artemether-lumefantrine on Day 0, 1 and 2 Washout period: more than 6 weeks
16025924|NCT02696954|Drug|Amodiaquine|Amodiaquine on Day 0, 1 and 2 Washout period: more than 6 weeks
16025925|NCT02696954|Drug|Artemether-lumefantrine|Artemether-lumefantrine on Day 0, 1 and 2 Washout period: more than 6 weeks
16025926|NCT02696954|Drug|Artemether-lumefantrine + Amodiaquine|Artemether-lumefantrine + Amodiaquine on Day 0, 1 and 2 Washout period: more than 6 weeks
16025927|NCT02696954|Drug|Primaquine|Primaquine on Day 0 Washout period: more than 1 week
16025928|NCT02696954|Drug|Artemether-lumefantrine + Primaquine|Artemether-lumefantrine on Day 0, 1 and 2 + Primaquine on Day 0 Washout period: more than 6 weeks
16025929|NCT02696954|Drug|Artemether-lumefantrine + Amodiaquine + Primaquine|Artemether-lumefantrine Day 0, 1 and 2 + Amodiaquine on Day 0, 1 and 2 + Primaquine on Day 0 Washout period: more than 6 weeks
16025930|NCT02696954|Drug|Artemether-lumefantrine + Primaquine|Artemether-lumefantrine on Day 0, 1 and 2 + Primaquine on Day 0
16025931|NCT02696941|Drug|Metformin|Metformin 500mg once daily and titrated weekly to a dose of 1000mg twice daily for 3 months
16025932|NCT02696941|Drug|SGLT2 inhibitor|SGLT2 inhibitor has been recommended to be started as part of routine clinical care
16025933|NCT02696928|Drug|Artemeter-Lumefantrine and MB (combination therapy)|AL first 3 days MB next 14 days
16025934|NCT02696928|Drug|Artemeter-Lumefantrine (combination therapy)|AL first 3 days
16025935|NCT02696928|Drug|Artemeter-Lumefantrine and Primaquine (combination therapy)|AL first 3 days PQ next 14 days
16025936|NCT02696915|Drug|Placebo|Patients received ultrasound guided fascial iliaca compartment blockade using normal saline 0.9%, 40 ml
16025937|NCT02696915|Drug|Bupivacaine|Patients received ultrasound guided fascial iliaca compartment blockade using bupivacaine 0.25%, 40 ml
16025938|NCT02696915|Device|Ultrasound guided fascia iliaca compartment block|Ultrasound guided fascia iliaca compartment block
16025939|NCT02696915|Drug|Intrathecal medications (bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms)|Intrathecal hyperbaric bupivacaine (15 mg) in conjunction with fentanyl 20 micrograms
16025940|NCT02696902|Drug|MEDI3902|Participants will receive a single IV dose of MEDI3902 500 mg and 1500 mg in MEDI3902 500 mg arm and MEDI3902 1500 mg arm, respectively.
16025941|NCT02696902|Other|Placebo|Participants will receive a single IV dose of placebo matched to MEDI3902.
16025942|NCT02696889|Procedure|ROSE-1 Protocol|A bone marrow aspiration will be performed under anesthesia in preparation for a diagnostic laparoscopy for full evaluation of the pelvic anatomy. Following laparoscopy, injection of BMSCs into the right ovary will occur.
16025943|NCT02696876|Device|Arthroscopic synovial brushing|The specific and novel surgical procedure that will be carried out here is synovial membrane brushing using a novel device that has been shown to release MSCs from the synovium in vitro. This technique will be carried out in the setting of therapeutic microfracture for cartilage defects.
16025944|NCT02696876|Procedure|Microfracture|Microfracture or marrow-stimulation is a surgical procedure to repair small isolated cartilage defects by recruiting bone marrow mesenchymal stromal cells by creating small holes ('micro fractures') in the sub-chondral bone. These cells are entrapped in the ensuing blood clot and contribute to partial repair of the cartilage.
16025945|NCT02696863|Behavioral|questionnaire|
16025946|NCT02696850|Drug|Budesonide|Participants will undergo 4-week treatment course that includes budesonide powder added to saline rinse.
16025947|NCT02696850|Drug|Saline alone|Participants will undergo 4-week treatment course that includes lactose (placebo) powder added to saline rinse.
16025948|NCT02696837|Device|ETT|
16025949|NCT02696837|Device|Proseal LMA|
16025950|NCT02696837|Drug|Rocuronium|
16025953|NCT02696824|Behavioral|Cognitive Behavioral Therapy for Adherence and Depression|"This treatment involves integrating CBT for depression with CBT for adherence following our Life-Steps approach."
16025954|NCT02696811|Dietary Supplement|White carrots|White carrots contain compounds called polyacetylenes, including falcarinol, falcarindiol and falcarindiol-3-acetate.
16025955|NCT02696811|Dietary Supplement|Oat biscuits|The 3 oat biscuits contain the same amount of fibre and sugar as the white carrot but without the polyacetylenes.
16025956|NCT02696798|Drug|Ixekizumab|Administered SC
16025957|NCT02696798|Drug|Placebo|Administered SC
16025958|NCT02696785|Drug|Ixekizumab|Administered SC
16025959|NCT02696785|Drug|Placebo|Administered SC
16025960|NCT02696785|Drug|Adalimumab|Administered SC
16025961|NCT02696772|Other|Energy intake|
16025962|NCT02696759|Other|Blood & Fecal Collection|Prior to first dose of chemotherapy: (a) Blood sample for research; (b) Fecal sample for research using a kit provided by the research staff for home collection of the fecal sample. The kit may be brought back to the clinic or mailed in a discreet package; (c) Questionnaire on health related quality of life. During chemotherapy: Questionnaires on health related quality of life and regarding any treatment side effects. Questionnaires will be completed every 2 weeks during standard office visits. After chemotherapy, prior to surgery: (a) Blood sample for research; (b) Fecal sample for research using a kit provided by the research staff for home collection of the fecal sample. The kit may be brought back to the clinic or mailed in a discreet package.
16025963|NCT02696746|Other|Observation|No intervention
16025964|NCT02696733|Device|Ultrasound|Ultrasound-guided obturator nerve localization
16025965|NCT02696733|Drug|lidocaine 2%|local anesthetic used to block the obturator nerve
16025966|NCT02696733|Drug|0.9% Natrium Chloratum with a 2nd generation cephalosporin|
16025967|NCT02696720|Drug|Lidocaine|
16025968|NCT02696720|Other|Sham|
16025969|NCT02696707|Procedure|LVEF 3 month|cardiac evaluation (by either transthoracic echocardiography or MUGA) every 3 months
16025970|NCT02696707|Procedure|LVEF 4 month|cardiac evaluation (by either transthoracic echocardiography or MUGA) every 4 months
16025971|NCT02696694|Other|Progesterone 25-75|Impact of serum progesterone concentrations [25-75] on the day of embryo transfer in egg donation cycles under hormonal replacement therapy
16025972|NCT02696694|Other|Progesterone <25, >75|Impact of serum progesterone concentrations (<25, >75) on the day of embryo transfer in egg donation cycles under hormonal replacement therapy
16025973|NCT02696681|Behavioral|Cognitive Behavioral Therapy|Integrating CBT for mental health and substance issues concern with CBT for health behavior change
16025974|NCT02696668|Other|modified FaME|Group based exercise classes one hour weekly for 16 weeks. Each exercise class will have 8-10 participants and two instructors. The components of the FaME programme include specific falls management strategies, such as bone loading, gait, dynamic posture, balance, reaction and co-ordination training, functional floor activities to improve coping skills and confidence.
16025975|NCT02696668|Other|Multisensory|"Group based exercise classes one hour weekly for 16 weeks. Each exercise class will have 8-10 participants and two instructors.Participants will receive an initial assessment by the research physiotherapists to determine the most appropriate interventions for each participant. Interventions used will include:
~Limits of stability training with eyes open / eyes closed
~Self induced movement strategies with eyes open / eyes closed
~Gaze stability exercises in sitting / standing / walking
~Sensory integration
~Habituation exercises"
16025976|NCT02696655|Behavioral|Behavioural intervention|Behavioural intervention administered by healthcare professionals targetting multiple lifestyle behaviours
16025977|NCT02696642|Drug|Anetumab ravtansine (BAY94-9343)|All subjects received anetumab ravtansine 6.5 mg/kg BW (body weight) once every three weeks
16025978|NCT02696629|Procedure|upper airway surgery|Uvulopalatopharyngoplasty, concomitant transpalatal advancement pharyngoplasty, nasal surgery or multi-level upper airway surgery
16025979|NCT02696629|Device|Continues positive airway pressure|Participants who are treated with continues positive airway pressure during sleep.
16025980|NCT02696629|Behavioral|education and follow up|Patients education and follow up:The impact of weight loss, sleep position, alcohol avoidance, risk factor modification and medication effects and follow-up are provided for patients' education.
16025981|NCT02696616|Drug|BI 655088|
16025982|NCT02696616|Drug|Placebo|
16025983|NCT02696603|Behavioral|Participant self-assessment surveys|At enrollment, participants are asked to complete a baseline health history and a participant-reported symptom inventory. Thereafter, participants are asked to respond to commonly used questions that assess Parkinson Disease symptoms and quality of life at regular intervals.
16025984|NCT02696603|Behavioral|Phonation|"Participants are asked to record themselves saying Aaah for 10 seconds using the iPhone microphone. This activity is designed to assess vocal features, including vocal tremor. The investigators extract features from the digital audio signals of these sustained phonations. The investigators apply feature selection and classifier algorithms and analyze these phonations using methods similar to those employed in the Parkinson Voice Initiative."
16025985|NCT02696603|Behavioral|Gait and balance|Participants are asked to walk back and forth for 30 seconds and then stand still for 30 seconds. Gait and balance are measured by gyroscope and accelerometer sensors. The investigators examine step-dependent and sequence-dependent features from these sensors. The investigators apply feature selection and classifier algorithms to analyze these data.
16025986|NCT02696603|Behavioral|Memory|Participants are asked to complete a visuospatial short-term memory game related to the Corsi block tapping test [Corsi, P.M. (1972)] as adapted by Kate Possin, PhD of the University of California San Francisco Memory and Aging Center (personal communication, 2015). In this activity, participants are presented with a grid of objects that change color in a set pattern. Participants are then asked to tap the objects in that same pattern. The investigators assess the sequence length completed.
16025987|NCT02696603|Behavioral|Dexterity|Participants are asked to tap on the phone screen with alternating fingers. This test can be done with either or both hands. The investigators record the rhythm, speed, and location of these taps using the touch sensors of the iPhone screen. The investigators assess participant dexterity through a combination of steadiness, speed, and tap precision.
16025988|NCT02696603|Behavioral|Participant open-response writing|Qualitative participant feedback is used to assess participant engagement with, understanding of, and acceptance of app-based research.
16025989|NCT02696603|Other|Parkinson mPower mobile application|Participants complete all described behavioral interventions via a dedicated iPhone app, Parkinson mPower.
16025990|NCT02696590|Dietary Supplement|Vitamin D3|two forms of vitamin D3 (Oral versus injection) were compared in MS and healthy groups.
16025991|NCT02696577|Drug|Low dose aspirin|
16025992|NCT02696577|Drug|Omega 3|
16025993|NCT02696564|Drug|Losartan|50mg once per day for two weeks,followed by 100mg once per day for 46 weeks if increased dose tolerated
16025994|NCT02696564|Drug|Placebo|one capsule per day for two weeks, followed by two capsules per day for 46 weeks
16025995|NCT02696551|Other|Medical education|
16025996|NCT02696538|Other|Functional Gait Assessment|Balance assessment
16025997|NCT02696538|Other|mini-Balance Evaluation Systems Test|Balance assessment
16025998|NCT02696538|Other|Berg Balance Scale|Balance assessment
16025999|NCT02696512|Drug|Polypharmacy using FDA-approved products|Battery of medications provided through a 12-week schedule including: Minocycline, Lamotrigine, Flumazenil, Modafinil, Bromocriptine, Donepezil, Methylphenidate, Methyl B12, Methylfolate, Rasagiline, Amantadine, Naltrexone and Levodopa/carbidopa.
16026000|NCT02696512|Device|Median Nerve Stimulation (MNS)|40 cycle/second (gamma range) asymmetric, 2 ms wavebands with 300 µs bursts at 20 milliamps bilaterally (randomized left arm and right arm sequencing algorithm) applied 20 seconds on and 40 seconds off for 8 hours per day.
16026001|NCT02696512|Dietary Supplement|Nutraceutical Supplementation|Battery of nutraceuticals provided through a 12-week schedule including: Acidophilus, Alpha-Lipoic Acid, Acetyl L-Carnitine,
16026002|NCT02696512|Other|Standard of Care|Standard of Care treatment
16026003|NCT02696499|Drug|PA101B|40 mg PA101B administered via inhalation twice daily for 7 weeks
16026004|NCT02696499|Drug|Placebo|Matching placebo administered via inhalation twice daily for 7 weeks
16026005|NCT02696486|Behavioral|Exercise Training|Study subjects will receive medically supervised aerobic and resistance exercise training for 1 hour per session, 3 times per week for 6 weeks at the Cardiac Rehab center and then transition to home or YMCA partnership based exercise with staff follow-up contact for an additional 3 weeks.
16026006|NCT02696473|Dietary Supplement|Carrot|
16026007|NCT02696460|Procedure|N2O/O2 analgesia|Analgesia for ulcer debridement procedure is provided by the inhalation of N2O/O2 gas premix.
16026008|NCT02696460|Procedure|Lidocaine/Prilocaine analgesia|Analgesia for ulcer debridement procedure is provided by topically administered lidocaine/prilocaine cream.
16026009|NCT02696447|Biological|Biomarkers assays|D-Dimer assays, C-reactive protein, blood platelets assays
16026010|NCT02696434|Drug|Naltrexone|daily dosing
16026011|NCT02696434|Drug|Placebo|daily dosing
16026012|NCT02696434|Drug|Buprenorphine|daily dosing
16026013|NCT02696408|Device|Laser treatment|"Patients randomized to the experimental arm receive in addition to mouthwash, preventive treatment of mucositis by LLLT performed by nurses consisting of daily scanning the entire oral cavity for 2 minutes with a power of 250 mW, starting with conditioning and ongoing until the onset of mucositis of grade 1.
~If the mucositis is localised, preventive laser will be kept on the healthy zones, and curative laser will be performed on painful zone. If the mucositis is general (more than 1 site), preventive laser is stopped for curative laser only."
16026014|NCT02696408|Device|Placebo|"Patients randomized to the Placebo arm receive in addition to mouthwash fictive laser treatment performed by nurses until the onset of mucositis of grade 1.
~If the mucositis is localised, fictive laser will be kept on the healthy zones, and curative laser will be performed on painful zone. If the mucositis is general (more than 1 site), fictive laser is stopped for curative laser only."
16026015|NCT02696395|Device|DePuy Tri-Lock® femoral stem + Deltamotion® acetabular component|
16026016|NCT02696395|Device|DePuy Corail® femoral stem + Deltamotion® acetabular component|
16026019|NCT02696369|Drug|2% lidocaine HCl with epinephrine 1:200,000|
16026020|NCT02696369|Drug|2% lidocaine HCl with epinephrine 1:80,000|
16026021|NCT02696356|Biological|GRN-1201|GRN-1201 is a vaccine comprised of 4 peptides
16026022|NCT02696343|Device|NTrainer|pulsed orocutaneous stimulation paired with tube feedings
16026023|NCT02696343|Device|SHAM blind pacifier|regular green Soothie pacifier paired with tube feedings
16026024|NCT02696330|Drug|clopidogrel|clopidogrel 75mg tablets with 300mg loading dose followed by 75mg oral tablets daily starting from day of hCG trigger till assessment of pregnancy by ultrasound
16026025|NCT02696330|Drug|enoxaparin|enoxaparin 40 mg by subcutaneous injection once daily starting from day of hCG trigger till assessment of pregnancy by ultrasound
16026026|NCT02696330|Drug|placebo|starch tablets with no active drug material is given daily starting from day of hCG trigger till assessment of pregnancy by ultrasound
16026027|NCT02696317|Device|Senofilcon A contact lenses with HydraLuxe™|Contact lenses worn during Period 1 or 2, as randomized
16026028|NCT02696317|Device|Senofilcon A contact lenses|Contact lenses worn during Period 1 or 2, as randomized
16026029|NCT02696304|Other|Adipose tissu repartition|absorptiometry,
16026030|NCT02696304|Other|Visceral and liver adipose tissue repartition|MRI,spectroscopy,
16026031|NCT02696304|Other|Preadipocyte quantification and adipose tissue inflamation|biopsy
16026032|NCT02696304|Other|Inflamation blood markers quantification|blood drawn,
16026033|NCT02696291|Drug|UV-4B 30 mg oral solution|UV-4B 30 mg oral solution administered TID (every 8 ± 0.5 hours) for 7 days
16026034|NCT02696291|Drug|UV-4B 75 mg oral solution|UV-4B 75 mg oral solution administered TID (every 8 ± 0.5 hours) for 7 days
16026035|NCT02696291|Drug|UV-4B 150 mg oral solution|UV-4B 150 mg oral solution administered TID (every 8 ± 0.5 hours) for 7 days
16026036|NCT02696291|Drug|UV-4B X mg (dose to be determined) oral solution|UV-4B X mg (dose to be determined) oral solution administered TID (every 8 ± 0.5 hours) for 7 days
16026037|NCT02696291|Drug|UV-4B Y mg (dose to be determined) oral solution|UV-4B Y mg (dose to be determined) oral solution administered TID (every 8 ± 0.5 hours) for 7 days
16026038|NCT02696291|Drug|Placebo|Placebo oral solution administered TID (every 8 ± 0.5 hours) for 7 days
16026039|NCT02696278|Other|Lesson about vegetables|During the introductory period, children will receive a lesson about vegetables 3 days a week for 3 weeks.
16026040|NCT02696278|Other|Vegetables|During the introductory period, children will be served vegetables 3 days a week for 3 weeks during snack time at their daycare center. During the intervention period, children will receive vegetables everyday for 3 weeks during snack time at their daycare center.
16026041|NCT02696278|Other|Hummus|During the introductory period, children will be served hummus, depending on their group assignment, 3 days a week for 3 weeks during snack time at their daycare center. During the intervention period, children will receive hummus, depending on their group assignment, everyday for 3 weeks during snack time at their daycare center.
16026042|NCT02696265|Procedure|CFAE guided ablation|CFAE/spatiotemporal dispersions mapping and ablation during AF aimed at restoring sinus rhythm during ablation. Pulmonal vein isolation will be checked before and after ablation using a mapping catheter.
16026043|NCT02696265|Procedure|PVI guided ablation|Wide antral pulmonary vein isolation during mapping catheter control of pulmonary vein signals
16026044|NCT02696239|Device|V-lock suture|
16026045|NCT02696239|Device|Vicryl Suture|
16026046|NCT02696239|Device|Lapra-Ty II|
16026047|NCT02696226|Drug|SAVR Warfarin|Warfarin treatment for 12 weeks with a target INR of 2-3 Warfarin treatment to begin on postoperative day 1-3 according to the patient's clinical status When warfarin treatment is discontinued, patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely
16026048|NCT02696226|Drug|SAVR Aspirin|Aspirin (81 mg/day) to begin within 1-3 postoperative days according to the patient's clinical status and continue indefinitely per standard of care.
16026049|NCT02696226|Drug|TAVR Warfarin and clopidogrel|Begin Warfarin and clopidogrel (75 mg/day) treatment within 1-3 days postop for 12 weeks with a target INR of 2-3 When warfarin is discontinued, begin aspirin (81 mg/day) and continue aspirin/clopidogrel for 12 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely
16026050|NCT02696226|Drug|TAVR Aspirin and clopidogrel|Aspirin (81 mg/day) and clopidogrel (75 mg/day) in periprocedural period and continue for 24 weeks At 24 weeks, study treatment will end and patients will be treated according to standard of care (aspirin 81 mg/day) indefinitely
16026051|NCT02696213|Other|Systematic, Comprehensive, One to One Training (SCOOT)|An occupational therapist trained by the principal investigator will perform 1.5 hour SCOOT sessions with participants one to two times a week over a period of 6 weeks. SCOOT will provide instruction and practice for performing scooter skills (i.e., instruction on driving, basic and advanced scooter skills) that are embedded in self-selected activities that participants want to perform using their scooters.
16026052|NCT02696213|Other|Six Week Delay|Participants will begin the SCOOT intervention after a six week delay.
16026053|NCT02696200|Device|Q Collar|The device is fitted to the neck to provide a comfortable and precise jugular compression that potentially mitigates cerebral slosh. The device will be worn inside the collar of an athletic compression shirt.
16026054|NCT02696187|Behavioral|KOLwebben|KOL-webben will be introduced to all people with COPD during their ordinary visits to the primary care center during a 3 months period. The introduction to KOL-webben will be tailored to each person's needs and include 1) registration of the patient at KOL-webben 2) showing and discussing specific content on KOL-webben (e.g. movies with exercises if the person needs exercise training) chosen to meet the needs of the individual 3) giving a card (A5 format) with address to KOL-webben, user information and references to chosen content on KOL-webben. All patients will also receive a pedometer.
16026055|NCT02696174|Other|HMI|A defined priced package of primary care services, including investigation and treatment such as procedures and medication, available at a selected clinic for 6 months
16026056|NCT02696161|Other|platelet rich plasma|Ultrasound-guided 3cc PRP injection between proximal carpal tunnel and median nerve.
16026057|NCT02696161|Other|5% dextrose|Ultrasound-guided 3cc 5% dextrose injection between proximal carpal tunnel and median nerve.
16026058|NCT02696148|Drug|liraglutide|For subcutaneous (s.c., under the skin) injection once daily.
16026059|NCT02696148|Drug|placebo|For subcutaneous (s.c., under the skin) injection once daily.
16026060|NCT02696122|Procedure|Local Group|General anesthesia willl be induced with propofol 2 mg mg. kg-1 and alfentanyl 30 mcg.kg-1. Once an appropriate depth of anesthesia had been obtained, a laryngeal mask airway (LMA) will be positioned. The anesthesia will be maintained by propofol 4 to 5 mg. kg-1.h-1. Ventilation will controlled by adjusting the flow volume and respiratory rate to keep the end-tidal CO2 level (PETCO2) between 30 and 40 mmHg. For local anesthesia, approximately 50 ml of 0.5% ropivacaive will infiltrated along the line of incision in the subcutaneous plane, followed by peripheral nerve block technique (e.g., ilioinguinal-hypogastric nerve block) and local wound infiltration at the fascial level.
16026061|NCT02696122|Procedure|Spinal anesthesia|Spinal puncture will be performed with the patient in the sitting position, using 27G disposable Quincke needles (B. Braun, Meisungen, AG). After obtaining CSF, 15 mg of 0.5% hyperbaric bupivacaine will be injected.
16026062|NCT02696109|Behavioral|Treatment As Usual|Participants in the TAU arm will be assigned to standard care at our partnering mental health agency. These clients are free to attend one-on-one counseling or any other services available at the clinic or elsewhere to address mental health challenges.
16026063|NCT02696109|Behavioral|Cornerstone|Participants in the experimental arm will be assigned a Transition Facilitator, a clinician with whom the client will meet one-on-one, and will be asked to attend once-a-week groups with other transition age youth. The groups will focus on issues relevant to successful transition to independent adulthood including stress and anger management and healthy relationships.
16026064|NCT02696096|Other|FMRI|all participants will complete 2 FMRIs
16125405|NCT01969565|Drug|Dexamethasone|
16026065|NCT02696096|Drug|Suboxone|all participants will be prescribed Suboxone for 4 months during their study participation
16026066|NCT02696083|Device|Provant Therapy System|
16026067|NCT02696070|Device|Provant Therapy System|
16026068|NCT02696057|Other|manual technics|soft tissue technics, joint mobilization and muscle energy technics were applied three sessions per week, totally six week.
16026069|NCT02696057|Other|Exercise|spinal stabilization exercise applied three sessions per week, totally six week.
16026070|NCT02696044|Drug|triheptanoin|Participants will begin a 2 week dose titration period to achieve study drug treatment comprising of 1-4 grams per kilogram of body weight (g/kg) daily depending on age. The age-related target dose will be mixed with food or formula and administered orally or by gastronomy tube. The total daily dose can be divided into 4 equal doses taken 4 times daily. Participants will maintain the age dependent dose treatment at the 1-4 g/kg daily for four months.
16026075|NCT02696018|Device|Ultrasonography|Ultrasonographic assessment of the diaphragm function
16026076|NCT02696005|Other|Exercise- Based Cardiac Rehabilitation Programme|Exercise- Based Cardiac Rehabilitation Programme for patients suffering from Heart Failure.
16026077|NCT02695992|Drug|Metoprolol|Dosage 100 mg o.d.
16026078|NCT02695992|Drug|Diltiazem|Dosage 360 mg o.d.
16026079|NCT02695966|Procedure|Whipples Surgery|Whipples Surgery
16026080|NCT02695940|Drug|LEO 124249 ointment 30 mg/g|
16026081|NCT02695940|Other|LEO 124249 ointment vehicle|
16026082|NCT02695927|Device|Computer rehabilitation glasses|
16026083|NCT02695914|Drug|Compound Qingre Granule|A kind of Chinese patent medicine, which is developed by Dr.Shuwen Zhang and Dr.Baoen Wang from Beijing Friendship Hospital.
16026084|NCT02695901|Drug|Chlorhexidine gluconate 0.12% (PerioGard®)|At baseline, subjects will receive a professional prophylaxis and will be instructed to withdrawal oral hygiene methods for 3 days. At day 4, 2 contra-lateral quadrants will be randomly chosen to receive a professional prophylaxis, being controls for plaque-covered surfaces. Subjects will then start to rinse twice daily with 15 ml mouthrinse containing Chlorhexidine gluconate (0.12%). Plaque indices will be recorded at baseline, day 4, and day 7.
16026085|NCT02695901|Drug|Nanoparticle solution of M. alternifolia oil (0.3%).|At baseline, subjects will receive a professional prophylaxis and will be instructed to withdrawal oral hygiene methods for 3 days. At day 4, 2 contra-lateral quadrants will be randomly chosen to receive a professional prophylaxis, being controls for plaque-covered surfaces. Subjects will then start to rinse twice daily with 15 ml mouthrinse containing a nanoparticle solution of M. alternifolia oil (0.3%). Plaque indices will be recorded at baseline, day 4, and day 7.
16026086|NCT02695888|Behavioral|Risky Driving Prevention|The web-based intervention to prevent risky driving targets knowledge, attitudes, perceived control and norms about driver inattention, with strategies to keep attention on the roadway.
16026087|NCT02695888|Behavioral|Teen Healthy Living|The control group will receive a web-based intervention for general health promotion and is designed to enhance participants' knowledge and ability to reduce their risk of adverse health conditions including, obesity and heart disease.
16026088|NCT02695875|Procedure|Aquatic therapy|"Pool material is contributed by Maria José Jove Foundation. The exercises that will be made during treatment, are designed and developed to improve core muscles and, in this way, improve postural balance."
16026089|NCT02695875|Procedure|Land-based therapy|"The material is contributed by Faculty of Physiotherapy at University of A Coruña.
~The exercises that will be made during treatment, are designed and developed to improve core muscles and, in this way, improve postural balance."
16026090|NCT02695862|Drug|Terlipressin|
16026091|NCT02695836|Other|Initial face-to-face dissemination workshop|Managers and directors of care will receive a printed report (tailored to their facility) on their facility's performance and performance of each unit (microsystem) within that facility. The workshop will include a presentation of the feedback reports with a particular focus on the core set of actionable context targets (Formal Interactions, Evaluation, Social Capital, Organizational Slack (OS) - Time) in the face-to-face workshops. Following the presentation, participants will discuss their reports in facilitated, round-table group discussions to a) help with interpretation of the results overall, b) draw attention to elements of context that are modifiable, c) encourage microsystem teams to work on improving the more modifiable areas
16026092|NCT02695836|Other|Face-to-face goal setting workshop|Sessions will build on the dissemination workshops and will be held three months after. Feedback reports on Formal Interactions, Evaluation, Social Capital, and Organizational Slack (OS) - Time will be discussed. Small group activities will take place including: a) reflecting on context data, b) performance goal setting using the 'tell and sell' method, which capitalizes on the workshop leaders' perceived expertise about what goals are achievable, c) establishing a series of proximal learning goals that will provide teams with explicit strategies for attaining performance goals set in (b). An action plan and instructions for reporting back at the Virtual Support Workshop will be provided.
16026093|NCT02695836|Other|Virtual support workshops|On virtual support workshop will be held six months after the feedback and goal setting workshop, and a second one another six months later. Groups will a) report on their progress in the proximal learning goals and strategies used toward their performance goals, b) discuss challenges they may be encountering, and c) receive support from the research team in addressing these challenges.
16026094|NCT02695836|Other|Face-to-face support workshops|On face-to-face support workshop will be held six months after the feedback and goal setting workshop, and a second one another six months later. Groups will a) report on their progress in the proximal learning goals and strategies used toward their performance goals, b) discuss challenges they may be encountering, and c) receive support from the research team in addressing these challenges. Workshops will be attended by all participating teams from a region, to maximize opportunities for teams to learn from one another and trouble-shoot together with the support of workshop leaders.
16026095|NCT02695836|Other|On-demand email and telephone support|Participants can contact the research team if needed with requests for support in defining or implementing improvement strategies or dealing with barriers towards improvement.
16026096|NCT02695823|Device|Ultrasound|"Ultrasound measurements of the optic nerve sheath diameter and intracranial Doppler, at 4 time points during surgery (incision, anhepatic phase + 30 min, declamping + 5 min, declamping + 30 min), and at day 1 and day 5 after surgery, to detect presence of intracranial hypertension.
~Search of any neurological complication during the 5 postoperative days."
16026097|NCT02695810|Drug|Dapagliflozin|10 mg per day as monotherapy for 13 weeks
16026098|NCT02695810|Drug|Metformin|2 x 850 mg per day as monotherapy for 13 weeks
16026099|NCT02695810|Behavioral|Exercise|Interval training, 5 times per week, 30 min per session
16026100|NCT02695797|Other|IVIG|IVIG (400mg/kg/day for 5 days) with oral prednisolone (60mg for 5days, than decrease by 10 mg every 2 day)
16026101|NCT02695797|Drug|Prednisolone|IVIG (400mg/kg/day for 5 days) with oral prednisolone (60mg for 5days, than decrease by 10 mg every 2 day)
16026102|NCT02695784|Dietary Supplement|Probiotic Continuation|This arm will continue to receive probiotics beyond 34 weeks corrected gestation until two months after discharge
16026103|NCT02695771|Drug|Mitomycin C|Cancer chemotherapeutic agent
16026104|NCT02695771|Drug|Gemcitabine|Cancer chemotherapeutic agent
16026105|NCT02695758|Procedure|Interscalene brachial plexus block|
16026106|NCT02695758|Procedure|bupivacaine extended-release liposome injection|
16026107|NCT02695745|Drug|V116517 aqueous suspension|300 mg (approximately 100 mL) aqueous suspension taken orally x 1 dose
16026108|NCT02695745|Drug|Celecoxib capsules|400 mg (2 capsules of 200 mg each) taken orally x 1 dose
16026109|NCT02695745|Drug|Placebo|Placebo for V116517 aqueous suspension taken orally x 1 dose and/or placebo for celecoxib, 2 capsules taken orally x 1 dose
16026110|NCT02695745|Drug|Capsaicin|1% administered topically
16026111|NCT02695732|Drug|Carvedilol|Carvedilol is started at a dose of 6.25 mg/d, and titrated to a maximum dose of 12.5 mg/d.Doses are increased every 7 days until ABPsys is not less than 95 mm Hg and HR is not less than 55 bpm.
16026112|NCT02695732|Device|endoscopy|Patients receiving endoscopic therapy (either endoscopic ligation or cyanoacrylate injection) every 4 weeks until eradication of varices.
16026113|NCT02695719|Drug|Placebo|Lubiprostone placebo-matching capsules
16026114|NCT02695719|Drug|Lubiprostone|Lubiprostone capsules
16026115|NCT02695706|Device|Laboratoires Mercurochrome Reparador|Developed for the treatment of damaged or fragile skin.
16026116|NCT02695693|Behavioral|TeachTown|TeachTown is an online program for students with autism that uses an applied behavior analysis framework to provide intervention in academic and pre-academic areas
16026117|NCT02695693|Behavioral|Discrete Trial Training|Discrete trial training is a one-on-one didactic behavioral intervention in which the teacher or therapist uses specific behavioral methods based on principles of operant conditioning, to help students gain skills
16026118|NCT02695693|Behavioral|Pivotal Response Training|Pivotal response training is a one-on-one child-lead behavioral intervention in which the teacher or therapist uses specific behavioral methods, leveraging the students interests, to help students gain skills
16026119|NCT02695693|Behavioral|Teaching in Functional Routines|Functional routines are sets of chained behaviors that students are taught that help them complete and manage specific activities in the classroom
16026120|NCT02695654|Drug|Levobupivacaine|14 ml of 0,25 % Levobupivacaine
16026121|NCT02695654|Drug|Clonidine|Clonidine 100 mcg
16026122|NCT02695641|Drug|1.25mg bevacizumab|Bevacizumab is a monoclonal antibody against VEGF-A. 1.25mg in 50ml 0.9% Sodium Chloride will be administered once as an intravenous infusion over 30 minutes.
16026123|NCT02695641|Drug|2.50mg bevacizumab|Bevacizumab is a monoclonal antibody against VEGF-A. 2.50mg in 50ml 0.9% Sodium Chloride will be administered once as an intravenous infusion over 30 minutes.
16026124|NCT02695628|Drug|18F-Fluoromisonidazole|Undergo [18F] FMISO PET/CT
16026125|NCT02695628|Procedure|Arterial Embolization|Undergo transcatheter arterial embolization
16026126|NCT02695628|Diagnostic Test|Computed Tomography|Undergo [18F] FMISO PET/CT
16026127|NCT02695628|Diagnostic Test|Positron Emission Tomography|Undergo [18F] FMISO PET/CT
16026128|NCT02695602|Procedure|Microdebrider-Assisted Inferior Turbinoplasty (MAIT)|
16026129|NCT02695602|Procedure|Submucous Resection with non powered instrument|
16026130|NCT02695576|Procedure|Lumbar Fusion Surgery|Interbody fusion with fixation
16026131|NCT02695576|Other|Physiotherapy|Examination by physiotherapist, motivation of the patient, training in body awareness, physical activity/Qigong, training in water, outdoor pole work, circle training, stabilization training, massage, stretching, lessons and practice in ergonomics.
16026132|NCT02695576|Other|Cognitive behavioral therapy|Individual and group lessons performed by psychologists.
16026133|NCT02695563|Drug|Lactoferrin|
16026134|NCT02695550|Drug|CT-707|
16026135|NCT02695537|Drug|Epidiolex|Epidiolex oral solution (100 mg/mL CBD concentration) with inactive ingredients including anhydrous ethanol, sesame seed oil, strawberry flavor, and sucralose).
16026136|NCT02695524|Other|Scapula-focused exercises|
16026137|NCT02695524|Other|Motor control exercises|
16026138|NCT02695511|Other|Caloric restriction|25% caloric restriction below baseline energy requirement
16026139|NCT02695498|Other|Mindfulness Based Stress Reduction|"MBSR is a standardized course in mindfulness mediation and yoga. The participants will meet weekly for 8 weeks for 2.5 hours, plus a mindfulness retreat day (approximately 6 hours) after the 6th class [9 total classes.] Mindfulness is cultivated through meditation, body scan (sequential attention to parts of the body), and mindful movement (bodily awareness during gentle stretching, based on yoga). The instructor also gives information about stress and stress relief."
16026140|NCT02695498|Other|Migraine/stress Education|The participants will be educated about migraine pathophysiology, headache triggers, stress, gentle stretches, and daily migraine readings.
16026141|NCT02695485|Procedure|innervated sensate flap|sensory reconstruction via digital nerve repair with the donor nerve of the flap
16026142|NCT02695472|Drug|80 Milligrams NSI-189|Orally Administered
16026143|NCT02695472|Drug|Placebo|Orally administered
16026144|NCT02695472|Drug|40 Milligrams NSI-189|Orally Administered
16026145|NCT02695459|Drug|cisplatinum and everolimus|Cisplatinum : 75 mg/m2 days 1,iv Everolimus : 7.5 mg daily: days 1-21 orally
16026146|NCT02695446|Drug|Minocycline|Oral extended release minocycline
16026153|NCT02695407|Other|3 days cannulation|assessment of artery stenosis after 3 days of artery cannulation
16026154|NCT02695407|Other|5 days cannulation|assessment of artery stenosis after 5 days of artery cannulation
16026155|NCT02695381|Drug|Etodolac-lidocaine topical patch|Once daily
16026156|NCT02695381|Drug|Placebo|Once daily
16026157|NCT02695368|Device|Novaerus NV800 on|The air-cleaner sterilizes the air particles through a plasma chamber. Air in the operating theatre is pumped through the chamber (80 - 380 m3/Hr) and by using a small current it transforms the gas in the vicinity of the electrode into plasma and eradicates any bacteria that pass through. The air-cleaner has to have been turned on for at least 2 days prior to the surgical intervention.
16026158|NCT02695368|Device|Novaerus NV800 off|The machine decribed above is running but the plasma filter chamber isn't active, i.e. the placebo group.
16026159|NCT02695368|Device|Novaerus NV800 on or off|Patients with multiple surgeries that have been operated during both periods when the apparatus has been on and off will belong to this mixed group.
16026160|NCT02695355|Drug|Methylphenidate (MPH)|Test 1: No medication. Registration of ERPs and behavioral data during an attention task. Test 2: Test repeated on a single dose of MPH. Outcome measure: Classification as responders or non-responders after a four weeks medication trial, based on rating scales from parents and Teachers.
16026161|NCT02695342|Behavioral|Home balance exercise program|
16026162|NCT02695329|Device|KneeAlign 2|Patients suffering non-severe varus deformity Osteoarthritis will be enrolled and randomly assigned into one of two treatment groups. Patients in investigational group will be treated with total knee arthroplasty and the accelerometer-based navigational device. Patients in control group will be treated with total knee arthroplasty with conventional instrumentation.
16026163|NCT02695316|Other|Focus Group Discussion in native Language|Group Interview with semi-structured key question, moderated in the native language of the participants. Interpreters translate the discussion for the Researcher analogically and adapt it culturally. The discussions are audio-recorded, summarized, translated and transcribed into German.
16026164|NCT02695316|Other|Focus Group Discussion|Group Interview with semi-structured key question, audio-recorded and ad verbatim transcription
16026165|NCT02695316|Other|One-to-one Interview|One-to-one Interview with semi-structured key question, audio-recorded and ad verbatim transcription.
16026166|NCT02695316|Other|Retrospective Quantitative Analysis|Retrospective Quantitative Analysis of questionnaires (Telephone Interpreting Protocols)
16026167|NCT02695303|Drug|Coppertone (BAY 987516)|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
16026168|NCT02695290|Drug|Afatinib|
16026169|NCT02695277|Device|AtriCure Bipolar System|
16026170|NCT02695277|Device|Standard Endocardial Ablation with Catheter|
16026171|NCT02695277|Device|AtriClip® PRO LAA Exclusion System|
16026172|NCT02695277|Device|Endocardial Ablation with Catheter|
16026173|NCT02695277|Device|Repeated Endocardial ablation(s)|
16026174|NCT02695264|Device|HS-1000 recording|
16026175|NCT02695251|Other|low AGE meal|Patients will receive a low AGE (eggs) meal
16026176|NCT02695251|Other|High AGE meal|Patients will receive a high (mixed nuggets) AGE (eggs) meal
16026177|NCT02695238|Procedure|Prophylactic Manual Rotation of persistent occipital posterior presentation|prophylactic manual rotation of persistent occipital posterior presentation on operative delivery will be performed in the experimental group
16026178|NCT02695225|Behavioral|Lay-led tobacco abstinence|Lay-led tobacco abstinence: Each intervention visit, which lasts an average of 30 minutes, will be delivered face-to-face in a mutually agreed upon convenient location (e.g. participant's home, county extension office). All behavioral and pharmacological intervention strategies will be delivered by the lay educator, with supervision by the county nurse (assigned by county with no overlap between conditions). As recommended by the USPHS guideline, all participants will set a 'quit date' and receive identical behavioral and pharmacological treatment throughout the intervention.
16026179|NCT02695225|Behavioral|Lay-led promotion of Ohio Quit Line|Lay-led promotion of Ohio Quit Line (control condition): Each participant will be given print information about the Ohio Tobacco QUIT LINE (1-800-QUIT-NOW) and encouraged to call for proactive telephone counseling and free NRT. Proactive telephone counseling and NRT administration will be provided by a QUIT LINE counselor, using their standard protocol.
16026180|NCT02695212|Drug|Apremilast|"Investigational Product: Apremilast
~Doses: Period A:
~10mg Per day, day #1, 10mg Twice Per day, day #2 10mg qAM, 20mg qHS day #3 20mg Twice per day, day #4 20mg qAM, 30 mg qHS day #5 30mg Twice per day, day #6
~Period B:
~30mg Twice per day, day #7 through week #24
~Period C:
~Week 28 (4 weeks off therapy), for final evaluation Mode of Administration: Oral"
16026181|NCT02695199|Procedure|Laparoscopic varicocelectomy|Traditional laparoscopic varicocelectomy assisted by laparoscopic Doppler ultrasound
16026182|NCT02695199|Procedure|Microscopic Subinguinal varicocelectomy|Infertile patients with clinically palpable varicoceles were selected to receive microscopic Subinguinal varicocelectomy
16026183|NCT02695186|Procedure|Gastroscopy|Gastroscopy and biopsies, as well as blood sample collection
16026184|NCT02695160|Biological|SB-FIX|Single dose of each of the 3 components of SB-FIX: ZFN1, ZFN2 and cDNA Donor.
16026185|NCT02695147|Procedure|TAVI|
16026186|NCT02695134|Other|Healing Touch|Healing Touch (HT) is an energy based approach to health and healing. It uses light touch to influence the energy field that surrounds the body, and energy centers which control the flow of energy to the physical body.
16026187|NCT02695108|Other|classical approach for neck pain|Patients with mechanical neck pain were instructed to do cervical exercise
16026188|NCT02695108|Other|scapular exercise on neck pain|Patients with mechanical neck pain were instructed to do scapular stabilization and cervical exercise
16026189|NCT02695069|Procedure|Random Placenta Margin Incision|A random hysterotomy incision is done in the placenta margin. To precisely determine the placental location and the edge of the placenta, preoperative ultrasonography is used in determining the optimal place for the uterine incision.
16026190|NCT02695043|Behavioral|RRTBIMS|TBI patients discharged from Bellevue inpatient rehabilitation and enrolled in the Rusk Rehabilitation Traumatic Brain Injury Model System (RRTBIMS)
16026191|NCT02695043|Behavioral|Multimedia Multicultural Educational Program for TBI (MMEPT)|
16026404|NCT02693405|Other|quality of life|measures of quality of life with questionnaires
16026192|NCT02695030|Device|Low Profile Visualized Intraluminal Support Device|LVIS device is intended for use with bare platinum embolic coils for the treatment of unruptured, wide neck, intracranial, saccular aneurysms.
16026193|NCT02695017|Device|Iso inertial|
16026194|NCT02695017|Device|Conventional machine|
16026195|NCT02695004|Drug|DKF-310|
16026196|NCT02695004|Drug|Placebo|
16026197|NCT02694991|Other|Osteopathic Manipulative Treatment|The thoracic wall is gently manipulated in conscious subjects in a supine position in order to facilitate greater diaphragmatic excursion. The thorax is palpated by applying a low pressure load directly on the skin in the direction of resistance, without any sliding over the skin or forcing of the subcutaneous tissue until it begins to yield and there is a sensation of softening. Sterile procedures are used when touching the patients near the surgical site. The treatment consists of a fixed and preordained sequence of three sessions, beginning with the costal arch on the diaphragm and then moving to the sternal area and, finally, the region of the thoracic outlet. The first two phases are performed from the right side, and the third from the head of the bed.
16026198|NCT02694978|Drug|Ferumoxytol|
16026199|NCT02694978|Drug|FCM|
16026200|NCT02694965|Other|observational|
16026201|NCT02694952|Biological|FAV-Africa|Polyspecific antivenom immunoglobulin F(ab)'2 fragments of equine origin manufactured by Sanofi Pasteur, S.A., Lyon, France. Per undiluted 1 ml, the multivalent serum contains ≥25 times the LD50 for mice exposed to venom of Bitis gabonica, Bitis arietans, Echis leucogaster, Echis ocellatus, Naja haje, Dendroaspis polylepis, Dendroaspis viridis, and Dendroaspis jamesoni, as well as ≥20 times the LD50 for mice exposed to venom of Naja melanoleuca and Naja nigricollis.
16026202|NCT02694952|Biological|EchiTabPlus-ICP|Polyspecific antivenom immunoglobulin of equine origin manufactured by the Clodomiro Picado Institute, San Jose, Costa Rica. Each 10 ml of undiluted antivenom contains enough antibody fragments to neutralize 30 mg of Echis ocellatus venom, 20 mg of Bitis arietans venom and 5 mg of Naga nigricollis venom.
16026203|NCT02694939|Behavioral|STAND (Behavior Therapy + Motivational Interviewing)|Parent-teen collaborative skills based behavior therapy targeting Executive functioning and Delay Aversion in Teens
16026204|NCT02694939|Behavioral|Usual Care|Community Therapists free to deliver any therapy they feel is indicated.
16026205|NCT02694926|Other|Education|During a session of 90 minutes duration, patients are educated in basic knowledge on adrenal insufficiency including the correct behaviour in emergency settings.
16026206|NCT02694913|Other|Non Interventional|This is a non therapeutic, pilot study.
16026207|NCT02694900|Other|Manually chest compressions|Chest compressions performed manually without any device
16026208|NCT02694900|Device|Cardiopump|Chest compressions performed with Cardiopump
16026209|NCT02694900|Device|LifeLine ARM|Chest compressions performed using mechanical chest compressions system LifeLine ARM
16026210|NCT02694874|Drug|Rosiglitazone|This is the experimental drug, rosiglitazone, being tested against placebo to assess its efficacy as an adjunctive treatment for severe malaria
16026211|NCT02694874|Drug|Placebo|This is the placebo control
16026212|NCT02694848|Drug|Salvianolate injection|Traditional Chinese medicine injection，a kind of innovative drugs developed by Shanghai institute of materia medica, Chinese academy of sciences after 13 years of research and development.the content of magnesium acetate was 80%, and the other 20% were magnesium acetate.It has the function of promoting blood circulation,removing blood stasis and blood stasis,and is used for treating coronary heart disease with stable angina pectoris.
16026213|NCT02694848|Drug|Aspirin|Molecular chemical formula: C9H8O4,molecular structure type: CH3COOC6H4COOH. It has the role of anti thrombosis In vivo, and it can inhibit the release of the platelet reaction, inhibit platelet aggregation, which is related to the reduction of TXA2 generation. Clinically itused to prevent the onset of cardiovascular and cerebrovascular diseases.
16026214|NCT02694835|Device|Delefilcon A contact lenses with UV Absorber|
16026215|NCT02694835|Device|Delefilcon A contact lenses|
16026216|NCT02694822|Drug|AGEN1884|anti-CTLA-4 antibody
16026217|NCT02694809|Drug|Conjugated Estrogens/Bazedoxifene|Given PO
16026218|NCT02694809|Other|Laboratory Biomarker Analysis|Correlative studies
16026219|NCT02694809|Other|Pharmacological Study|Correlative studies
16026220|NCT02694809|Other|Placebo|Given PO
16026221|NCT02694809|Procedure|Quality-of-Life Assessment|Ancillary studies
16026222|NCT02694809|Other|Questionnaire Administration|Ancillary studies
16026223|NCT02694796|Behavioral|Physical activity program after a balneotherapy|workshop during the balneotherapy associated to an automated program of physical activity after the end of the balneotherapy available during 12 months
16026224|NCT02694783|Biological|PyVST|ex vivo generated polyomavirus-specific T cells from HLAmatched donor
16026225|NCT02694770|Biological|Neihulizumab Treatment|Monoclonal antibody
16026226|NCT02694770|Biological|Conventional Treatment|2nd line therapy for aGvHD at the discretion of attending physician, including but not limited to biologics such as ATG, TNF-alpha inhibitors, pentostatin, sirolimus, mycophenolate mofetil and extracorporeal photopheresis.
16026227|NCT02694757|Device|Ostom-i device|The Ostom-i alert (OIA) is a discrete novel device which clips onto any ostomy bag from edge to edge and measures the horizontal tension between the edges over time, as a result of stool volume in the ostomy. It is an FDA approved medical device.
16026228|NCT02694744|Drug|patiromer|8.4 g/day starting dose, administered orally
16026229|NCT02694731|Behavioral|Mobile application intervention (Device: Smartphone)|Consists of the app described in the arm description.
16026230|NCT02694718|Drug|Capecitabine|Capecitabine is available as 50 mg and 500 mg tablets. It will be administered as a 1000mg/m^2 bid orally on Days 1-14, and at a dose of 825mg/m^2 bid on Days 22-35 and 43-56.
16026231|NCT02694718|Drug|Oxaliplatin|Oxaliplatin is available in vials containing 50 mg or 100 mg. It will be administered as a oxaliplatin 130mg/m^2/d intravenously on Day 1 and 50mg/m^2/d on Days 22, 29, 43 and 50 prior to radiotherapy up to Week 9 followed by surgery period.
16026232|NCT02694705|Device|Continuous Positive Airway Pressure (CPAP)|CPAP provided by a portable Draeger Oxylog® 3000 plus ventilator
16026233|NCT02694705|Device|Bag-Valve-Mask (BVM)|Preoxygenation provided by BVM device, oxygen flow rate 15 l/min
16026234|NCT02694705|Device|Non-rebreather Mask (NRM)|Preoxygenation provided by NRM, oxygen flow rate 15 l/min
16127258|NCT01955720|Drug|Placebo|
16026235|NCT02694692|Procedure|Vaccinations at 2, 6, 12 and 18 month|Participants will be invited back to IWK Health Centre at time points that correspond to their 2, 6, 12 and 18 month vaccinations and will receive their vaccinations according to Nova Scotia schedule.
16026236|NCT02694692|Behavioral|Neurodevelopment assessment at 18 corrected age|During the 18 month follow-up visit, the infants will also undergo neurodevelopmental assessment. Trained medical assessors also blind to original study group assignment will examine the child using the BSID-III Cognitive and Motor Sections. Participants will also be contacted at the infants 18 month corrected postnatal age for the BSIDIII. Parents will be asked to complete the Early Childhood Behaviour Questionnaire and the Brief Infant Toddler Social Emotional Assessment.
16026237|NCT02694679|Behavioral|CBNH|The household-level intervention package targets health behaviors surrounding neonatal and maternal health, and diarrhea and respiratory illness prevention and management.
16026238|NCT02694666|Other|Controlled whole-body vibration training|The intervention is an 8-week program
16026239|NCT02694653|Drug|Placebo|100 mL of normal saline IV given 30 minutes prior to elective c/section incision vs acetaminophen 1000 mg IV
16026240|NCT02694653|Drug|Acetaminophen|1000 mg acetaminophen in 100 mL normal saline IV given 30 minutes prior to elective c/section incision vs placebo
16026241|NCT02694640|Behavioral|Reach Plus|"In Months 1-3, participants in this group will receive the previously tested telephone counseling for exercise. RTR volunteers or coaches will be asked to contact participants by telephone weekly over 3 months (12 calls). In months 4-9, participants will no longer receive calls from RTR coaches and will be encouraged to use the heart rate monitors and pedometers during exercise. Participants will continue to complete their exercise logs and receive feedback reports from study staff."
16026242|NCT02694640|Behavioral|Reach Plus Phone|"In Months 1-3, participants in this group will receive the previously tested telephone counseling for exercise. RTR volunteers or coaches will be asked to contact participants by telephone weekly over 3 months (12 calls). In months 4-9, these participants will have the opportunity to continue to receive support calls from their coach. Participants will also continue to complete their exercise logs and receive feedback reports from study staff."
16026243|NCT02694640|Behavioral|Reach Plus Message|"In Months 1-3, participants in this group will receive the previously tested telephone counseling for exercise. RTR volunteers or coaches will be asked to contact participants by telephone weekly over 3 months (12 calls). In months 4-9, participants will receive messages by email or text to motivate, prompt and reinforce continued exercise. Participants will also continue to complete their exercise logs and receive feedback reports from study staff."
16026244|NCT02694627|Behavioral|MenCare+/Bandebereho fathers'/couples' group education|MenCare+/Bandebereho is a 3 year project to engage men in maternal, newborn and child health (MNCH) and in sexual and reproductive health in Rwanda. A core component of the project is fathers'/couples' group education. The target participants are first-time parents or parents of young children living in 16 rural and semi-urban sectors selected by the implementing partner in collaboration with local authorities. The MenCare+/Bandebereho fathers'/couples' group education engages men in 15 weekly sessions of group discussion, critical reflection and interactive activities led by a trained facilitator using a curriculum developed by RWAMREC and Promundo and approved by the Rwandan Ministry of Health, adapted from the Program P Manual. Men's partners participate in 6-8 sessions. The sessions focus on men's role in MNCH, family planning, sharing household responsibilities, intimate partner violence, conflict resolution, family budgeting, and gender equality.
16026245|NCT02694614|Behavioral|smartphone-assisted dietary coaching|
16026246|NCT02694601|Dietary Supplement|Control|4-hour visit with no caffeine is given during a standardize breakfast follow by repeated blood sampling.
16026247|NCT02694601|Dietary Supplement|Caffeine low dose|4-hour visit with a dose of 2.5 mg/kg of caffeine is given during a standardize breakfast follow by repeated blood sampling.
16026248|NCT02694601|Dietary Supplement|Caffeine high dose|4-hour visit with a dose of 5 mg/kg of caffeine is given during a standardize breakfast follow by repeated blood sampling.
16026249|NCT02694588|Drug|Infliximab|HD-endoscopy, CLE, endoscopic ultrasound after application of TNF alpha antibody
16026250|NCT02694588|Drug|Vedolizumab|HD-endoscopy, CLE, endoscopic ultrasound after application of Anti-Integrin antibody
16026251|NCT02694562|Device|40um Embozene TANDEM Microspheres|40um Embozene TANDEM Microspheres loaded with Irinotecan (up to 150 mg).
16026252|NCT02694549|Device|CaveoVasc|
16026253|NCT02694536|Drug|Erlotinib|Participants will receive erlotinib tablets as 100 milligrams (mg) orally (PO) once daily.
16026254|NCT02694536|Drug|Gemcitabine|Participants will receive gemcitabine as 1000 milligrams per meter-squared (mg/m^2) via intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36, and 43 of the first 8-week cycle, and thereafter on Days 1, 8, and 15 of every 4-week cycle.
16026255|NCT02694523|Drug|risankizumab|Risankizumab administered by subcutaneous (SC) injection
16026256|NCT02694523|Biological|adalimumab|Adalimumab pre-filled syringe, administered by subcutaneous (SC) injection
16026257|NCT02694523|Drug|placebo for risankizumab|Placebo risankizumab administered by subcutaneous (SC) injection
16026258|NCT02694523|Biological|placebo for adalimumab|Placebo for adalimumab pre-filled syringe, administered by subcutaneous (SC) injection
16026259|NCT02694510|Other|Light-protection of TPN solutions|TPN bags and infusion sets in the Light-protected group will be covered by aluminum foils to protect the inside TPN solution from exposure to ambient or photo-therapy lights in the NICU. Protection will be made throughout the study period until the infant reaches full feeding and TPN is discontinued.
16026260|NCT02694497|Other|Chlamydia care as usual|
16026261|NCT02694484|Other|Blood and stool samples|Blood sample at Day 1 and blood and stool sample at the next visit
16026262|NCT02694471|Behavioral|physical inactivity or bed rest with supervised recovery|All (older and younger) participants underwent 14 day of horizontal bed rest with all 24 hour daily activities were performed lying in a bed. Maximal one pillow was allowed. 28-day supervised recovery was performed 3 times weekly for 75 minutes/session.
16026263|NCT02694458|Other|Early vancomycin monitoring and bayesian dosage adjustment|Measure of vancomycin serum concentration at the 3rd hour of treatment and adjustment of vancomycin dosage at the 6th hour of treatment using a bayesian approach. Then measure of vancomycin serum concentration at the 24th hour of treatment.
16026264|NCT02694458|Other|usual vancomycin dose and monitoring strategy|Vancomycin serum concentration will be measured at the 24th hour of treatment.
16026266|NCT02694432|Behavioral|GOALS|16 weeks of online support to improve blood pressure using traditional behavioral lifestyle approaches and medication adherence support.
16026267|NCT02694432|Behavioral|Minding GOALS|16 weeks of online support to improve blood pressure using traditional behavioral lifestyle approaches and medication adherence support, coupled with a mind-body-behavior program to further enhance improvements in blood pressure.
16026268|NCT02694419|Device|Doppler evaluation|Endometrial volume, endometrial and subendometrial vascularity indices are measured by 3D power Doppler
16026269|NCT02694406|Device|MRI perfusion|contrast-enhanced MR imaging including perfusion weighted imaging (PWI)
16026270|NCT02694393|Drug|sodium nitrite|inhalation of 46 or 80 mg of sodium nitrite by electronic nebulization
16026271|NCT02694367|Other|Investigate the MAP kinase signaling pathways through ERK and p-ERK proteins|
16026272|NCT02694354|Drug|BI 685509|
16026273|NCT02694354|Drug|Placebo|
16026274|NCT02694341|Procedure|Abdominal traction stitch|Abdominal traction stitch to prevent prolapse of the Bakri balloon. A suture is tied through the uterine end shaft hole of the Bakri balloon. The other end of the suture is placed through the uterine wall. The balloon is positioned in the lower segment.The abdominal traction stitch is held by forceps and fixed, with cephalad traction applied continuously to the balloon, preventing balloon prolapse.The abdominal traction stitch is fixed by an umbilical cord clamp on the abdominal wall, preventing the suture from receding into the abdominal cavity, and, thus, maintaining the correct position of the balloon and preventing prolapse. Removal of the balloon is easy, with no resistance; the suture does not hinder balloon removal. At the time of balloon removal, the suture that was placed through the abdominal wall will traverse the intra-abdominal and intrauterine cavities, and should be kept clean.
16026275|NCT02694341|Device|Bakri Balloon|uterine compression balloon
16026276|NCT02694328|Drug|ALKS 3831|Daily dosing
16026277|NCT02694328|Drug|Olanzapine|Daily dosing
16026278|NCT02694315|Other|Bishop score|calculation of modified Bishop score in numbers by digital vaginal examination
16026279|NCT02694315|Other|cervical length|measuring cervical length by trans-vaginal ultrasound
16026280|NCT02694302|Device|Walkbot|Walkbot(robot assisted gait training) 30 minutes and conventional physical therapy 30 minutes each per day to be administered 5 times a week for 3 weeks.
16026281|NCT02694302|Device|Conventional physical therapy|Conventional physical therapy 30 minutes to be administered twice a day, 5 times a week for 3 weeks.
16026282|NCT02694289|Drug|Metformin|Treatment/continuation of metformin therapy during admission
16026283|NCT02694289|Drug|Subcutaneous (sliding scale) Insulin|Discontinue Metformin and be placed on subcutaneous sliding scale insulin during admission
16026284|NCT02694276|Behavioral|Internet-based cognitive behavior therapy|The CBT treatment lasts for 10 weeks and includes the following: Education on the role of anxiety on cardiac function and the effects of symptom preoccupation and avoidance QoL and depression in AF, creating a vicious cycle; exposure to physical sensations that are similar to AF symptoms (e.g.,palpitations due to physical activity or stress) to reduce fear of these symptoms; exposure to situations or activities previously avoided and abolishment of behaviors that fruitlessly aim to prevent triggering of AF episodes or to control symptoms; and behavioral activation aiming to increase social and physical activity and reduce depressive symptoms. Therapist support is provided at least once weekly through the platform developed for the purpose. Therapists are trained CBT-psychologists.
16026285|NCT02694263|Drug|Canagliflozin|Comparison of Canagliflozin (Invokana™) vs. standard dual therapy (Repaglinide, Pioglitazone, Gliclazide or Glimepiride) for the treatment of Type 2 Diabetes.
16026286|NCT02694263|Drug|Repaglinide|Comparison of Canagliflozin (Invokana™) vs. standard dual therapy (Repaglinide) for the treatment of Type 2 Diabetes.
16026287|NCT02694263|Drug|Pioglitazone|Comparison of Canagliflozin (Invokana™) vs. standard dual therapy (Pioglitazone) for the treatment of Type 2 Diabetes.
16026288|NCT02694263|Drug|Gliclazide|Comparison of Canagliflozin (Invokana™) vs. standard dual therapy (Gliclazide) for the treatment of Type 2 Diabetes.
16026289|NCT02694263|Drug|Glimepiride|Comparison of Canagliflozin (Invokana™) vs. standard dual therapy (Glimepiride) for the treatment of Type 2 Diabetes.
16026290|NCT02694250|Device|DTRAX® Cervical Cage with DTRAX Bone Screw|DTRAX Cervical Cage is an intervertebral fusion device that provides mechanical support to the spine. DTRAX Cervical Cage is intended to be used in cervical spine fusion surgery. DTRAX Bone Screw is indicated for use in arthrodesis and provides supplemental fixation. .
16026291|NCT02694237|Behavioral|Model|Each participant will receive an informed consent discussion with the aid of an anatomic knee model.
16026292|NCT02694237|Behavioral|Knee Anatomy Video|Each participant will hear a scripted informed consent discussion while they watch a knee anatomy video orated by an interviewer.
16026293|NCT02694237|Behavioral|Verbal|Each participant will receive a verbal informed consent discussion without a visual aid.
16026294|NCT02694224|Drug|vismodegib|Smo inhibitor
16026295|NCT02694224|Drug|Paclitaxel|Paclitaxel (80 mg/m2) weekly x 12 doses followed by sequential dose dense Epirubicin (90 mg/m2) plus Cyclophosphamide (600 mg/m2) each 2 weeks x 4 doses with granulocyte macrophage colony stimulating factors (GM-CSF) support
16026296|NCT02694224|Drug|Epirubicin|dose dense Epirubicin (90 mg/m2) plus Cyclophosphamide each 2 weeks x 4 doses with GMCSF after Paclitaxel
16026297|NCT02694224|Drug|Cyclophosphamide|dose dense Cyclophosphamide (600 mg/m2) together with Epirubicin each 2 weeks x 4 doses with GMCSF after Paclitaxel
16026298|NCT02694211|Behavioral|ProMES|Productivity measurement and enhancement system (ProMES) is a participatory intervention for productivity enhancement. Core strategies of this method could be addressing known work stressors such as absence of influence and control, insufficient interaction with coworkers, unclear and conflicting tasks, insufficient participation in decision-making and insufficient feedback
16026321|NCT02694016|Procedure|Remote ischemic preconditioning|A blood pressure cuff is placed around the right leg on the level of the thigh. Randomization is performed after this, using sealed envelopes with covariate balancing for age and sex. Regardless of the outcome of the randomization the cuff is left in place so as not to give any indication of which group the patient belongs to. If the patient is randomized into the remote ischemic preconditioning group (RIPC) then four (4) cycles of five (5) minute inflation are given after induction. Each cycle is followed by a five (5) minute interval of reperfusion. Cuff pressure should be 200mgHg at least (RRsyt + 100mmgHg) during the inflation periods.
16026299|NCT02694198|Other|fetal fibronectin measurement|All patients will be put in the dorsal lithotomy position.Using a proper light source and sterile gloves, a sterile speculum free of lubricants will be placed into the vagina before vaginal examination by senior resident and the special Dacron swab from the FFN kit will be used to collect a sample of secretions from the posterior fornix. The sample should be obtained prior to collection of any vaginal wet preparations, before any cervical manipulation or cervical cultures, and if enough amount of fluid (about 2 ml) is not found, vagina will be washed with 2 ml of normal saline.The swab will be placed in sterile plastic containers which will be stored until assayed quantitatively with an Enzyme-Linked Immuno Sorbant Assay.
16026300|NCT02694185|Other|Caplan IVR|This intervention will consist of: proactive real-time adherence monitoring of patients and targeting of individuals only when they have exhibited non-adherence behavior (i.e., if patients have not refilled their medication more than 4 or 7 days after it was due to be refilled). The intervention will employ a tailored, escalating-intensity approach which begins with some combination of personalized short messaging service (SMS) text messages and interactive voice response (IVR) telephone technology, depending on patient preference. Patients failing SMS and then IVR by not refilling their medication (or declining SMS and failing IVR) escalate to a trained research interventionalist (typically, a clinical pharmacist). The interventionalist will contact the patient and address adherence barriers based on the dimensions outlined by the World Health Organization (WHO) that are specific to each patient.
16026301|NCT02694172|Other|Fiber rich cereal bars|Two cereals per day and per subject for 4 weeks
16026302|NCT02694146|Drug|Platelet rich plasma|Platelet rich plasma (PRP) is a platelet concentrated obtained from autologous blood centrifugation. This concentration technique provides larger amounts of biologically active molecules, mainly growth factors that are responsible for tissue repair. PRP (platelet rich plasma) contains a higher concentration of platelets from baseline (150,000-350,000 / ul).
16026303|NCT02694146|Drug|Hylan G-F 20|Hylan G-F 20 is a viscous, sterile and non-pyrogenic elasto fluid containing hylan. Hylans are byproducts from hyaluronate (hyaluronic acid sodium salt), consisting of repeating disaccharides of N-acetylglucosamine and sodium glucuronate. Hylan G-F 20 replaces and supplements the synovial fluid. It is effective at any stage of the joint pathology.
16026304|NCT02694133|Procedure|Smart Phone Based Assistive Speech Therapeutic System|use the mobile device, which with the camera and speaker, for patients to practice the naming training at home, and assess the speech ability every 2-4weeks by speech therapist via telerehabilitation platform. Concise Chinese Aphasia Test (CCAT) will be used as the assessment tool for evaluation speech ability and functional ability.
16026305|NCT02694133|Procedure|Mobile phone-based tele rehabilitation program|Mobile phone-based tele rehabilitation program
16026306|NCT02694107|Other|Proprioceptive exercises|
16026307|NCT02694107|Other|Control|
16026308|NCT02694094|Dietary Supplement|Modified Atkins or Ketogenic Diet|Biochemical and vascular parameters will be compared from adults who have been on ketogenic diet therapy for > 12 months to adults naive to ketogenic diet therapy. In addition, adults naive to diet therapy who subsequently begin diet therapy will have these same parameters followed over time.
16026309|NCT02694081|Procedure|Uncut Roux-en-Y Reconstruction|All surgical procedures will be performed by the single surgery team ,which is leaded by professor Wang Quan. Uncut Roux-en-Y construction will be used in this group.
16026310|NCT02694081|Procedure|Billroth II Reconstruction|All surgical procedures will be performed by the single surgery team ,which is leaded by professor Wang Quan. Uncut Roux-en-Y construction will be used in this group.
16026311|NCT02694068|Other|Peritoneal Equilibrium Test|These will be done as part of standard of care procedures. PETs will not be performed solely for research purposes.
16026312|NCT02694068|Other|4 hour dwell of 2.5/4.25% dextrose solution|If a PET is not performed annually as part of standard of care, subjects will undergo a 4 hour timed dwell with either 2.5 or 4.25% dextrose solution. This will be for the purposes of sample collection and/or measurement of ultrafiltration capacity.
16026313|NCT02694055|Other|Proactive Community Case Management|CHWs will be trained and deployed to conduct daily active case finding home visits door-to-door for at least two hours each day, with the goal of visiting each household at least two times each month. At these active case finding home visits, CHWs will screen each household of sick children and will offer home pregnancy testing and family planning services to reproductive aged women. For patients they identify, they will offer counselling, diagnostic services, care, accompaniment, and referral according to an iCCM service delivery package.
16026314|NCT02694055|Other|Integrated Community Case Management|CHWs will be trained offer counselling, diagnostic services, care, accompaniment, and referral according to an iCCM service delivery package to patients that visit them at their work post.
16026315|NCT02694055|Other|Removal of point-of-care user fees|User fees will be removed across the catchment areas for both study and control villages. No fees will be charged for care by CHWs or at all primary care centres.
16026316|NCT02694055|Other|Infrastructure improvements at primary health centre|Targeted infrastructure improvements to rehabilitate, expand and equip the capacity of the seven government primary care centres in the study area. Each health center will be equipped with solar power.
16026317|NCT02694055|Other|Training of primary health centre staff|"Health center staff will receive targeted training in
~Integrated management of childhood illness
~Diagnosis and treatment of simple and severe cases of malaria
~Helping babies breathe
~Managing post-partum haemorrhage
~Gestational dating using frontal height, last menstrual period and ultrasound
~Family planning counselling and administration of long-acting contraceptives
~Pharmacy stock management
~Health center management"
16026318|NCT02694042|Behavioral|Mission is Remission®|A web-based teaching a support program for adolescents living with inflammatory bowel disease (IBD).
16026319|NCT02694029|Device|Active Breathing Coordinator (ABC)|The ABC system has a digital spirometer that records real time breathing. This group will be administered 14 fractions with ABC-assisted DIBH, followed by 14 fractions with VRT-assisted DIBH
16026320|NCT02694029|Device|VisionRT|A technology for implementing the deep inspiration breath-hold technique is real-time surface photogrammetry. This group will be administered 14 fractions with VRT-assisted DIBH, followed by 14 fractions with ABC-assisted DIBH.
16026401|NCT02693418|Drug|Acidform 3 g|Effect of 3 g vaginally administered Acidform on pH over 7 days
16026402|NCT02693405|Other|Executive functions|measures of executive functioning with tasks
16026403|NCT02693405|Other|social cognition|measures of socio-cognitive functioning with tasks
16026322|NCT02694003|Behavioral|BNBD-NDD Intervention|The intervention comprises 5 sessions, consisting of educational materials followed by interactive activities, designed to facilitate the successful application of the behavioural strategies. Clinicians and caregivers share tips and recommendations about implementing the strategies, providing modelling and emotional/social support, through supplemental videos. Caregivers complete daily internet sleep diaries that track sleep-related variables and patterns, associations between changes in caregivers' behaviour and children's sleep, and associations between changes in children's sleep and their daytime functioning. At the end of each session, caregivers receive a personalized plan for the week, linking relevant session strategies to caregivers' goals for their children's sleep.
16026323|NCT02693990|Radiation|Intensity Modulated Proton Therapy (IMPT)|Radiation Therapy - Intensity Modulated Proton Therapy (IMPT)
16026324|NCT02693977|Procedure|Sleep Endoscopy|Sleep endoscopy will be performed prior to the adenotonsillectomy, under the same general anesthetic. The endoscopy will be performed using a flexible fiber optic endoscope which will be advanced trans nasally into the pharynx down to the level of the hypopharynx. We will take note of any obvious septal deviation or nasal obstruction as well as adenoid hypertrophy, and dynamic collapse at the level of the velum, oropharynx/lateral walls, tongue base, epiglottis, and supraglottis. Relatively fixed structures such as the nasal airway and adenoids should require 1 minute to fully assess. The endoscope will then be held for 2 minutes of observation above each subsequent site of potential dynamic airway collapse (the velum, oropharynx/lateral walls, tongue base, epiglottis/supraglottis).
16026325|NCT02693964|Other|Bone density and carotid ultrasound|All participants will be asked for relevant medical, personal, family and diabetes history, treatment and complications, and history of falls and fractures and will undergo measurement of bone density, carotid ultrasound and a blood draw.
16026326|NCT02693951|Drug|Cefotiam|Prophylactic use of antibiotics group: Half an hour before endoscopic treatment, cefotiam 2.0g intravenous
16026327|NCT02693938|Device|Follicular Euglycemic clamp|Follicular Euglycemic clamp during follicular phase
16026328|NCT02693938|Device|Luteal Euglycemic clamp|Luteal Euglycemic clamp during luteal phase
16026329|NCT02693912|Procedure|Bronchoscopy|Bronchoscopy will be implemented under sedation in both groups.
16026330|NCT02693899|Other|Non Interventional study|The samples of the study were made in conjunction with blood tests done routinely, no additional venipuncture is provided by the study. Flt3L plasma concentration will be measured at different time monitoring of patients according to their pathology (Acute lymphoblastic leukemia or acute myeloid leukemia). The exact number of samples will vary for each patient depending on the course of the illness, it is expected up to 15 blood tubes 9mL.
16026331|NCT02693886|Other|doctor experience|
16026332|NCT02693873|Behavioral|GLA:D Canada (education and neuromuscular exercise program)|"EDUCATION: 2 sessions cover OA topics (e.g. diagnosis, causes, risk factors, symptoms, treatment). Education also aims to strengthen beliefs in the value of exercise to control and improve pain and encourage exercise adherence after the program.
~EXERCISE: 12 sessions (twice weekly, each about 1-hour) are supervised by therapist(s) with individual progression of exercises when good neuromuscular functioning is demonstrated. Exercises are performed using both legs and focus on sensorimotor control, functional stability, and muscular strength. Exercises involve a 10-minute cycle warm-up followed by a 4-station circuit (i.e. 2 exercises per station with 3 progressive levels of difficulty performed in 2 to 3 sets with 10 to 15 repetitions)."
16026333|NCT02693860|Drug|huJ591|Antibody is derived from a hybridoma originally produced in the Weill Medical College Laboratory of Urological Oncology. Treatment with 100 mg of HuJ591 will be administered as an intravenous infusion at a concentration of 5 mg/mL and rate of <5 mg/minute.
16026334|NCT02693860|Drug|89Zr-J591|Drug product is manufactured by the radiochemistry staff of Citigroup Biomedical Imaging Center (CBIC) research core facility. Radiolabeling of DFO-huJ591 with 89Zr is achieved by the addition of 89Zr-oxalate to the DFO-huJ591 in ammonium acetate buffer.
16026335|NCT02693834|Device|Posterior Leaf spring AFO|Posterior Leaf Spring AFO is an over the shelf polypropylene ankle foot orthosis to assist foot drop.
16026336|NCT02693834|Device|Double adjustable AFO|Double adjustable AFO is a custom AFO with double action metal upright joints
16026337|NCT02693821|Drug|Gabapentin|gabapentin 300 mg per day, orally during 30 days
16026338|NCT02693821|Other|Placebo|Placebo 300 mg per day, orally during 30 days
16026339|NCT02693808|Procedure|Autologous fat injection|Injection in one side with autologous fat and the other side with hyaluronic acid.
16026340|NCT02693808|Procedure|Hyaluronic acid injection|Injection in one side with autologous fat and the other side with hyaluronic acid.
16026341|NCT02693795|Other|Baduanjin exercise|"A detailed description of a standardized Baduanjin exercise protocol complied with the Health Qigong Baduanjin Standard enacted by the General Administration of Sports in 2003."
16026342|NCT02693795|Other|aerobic exercise|Participants allocated to the usual exercise control group receive a closely supervised, group-format aerobic exercise program located on cardiac rehabilitation centre lasting 3 month. The program is consistent with the current recommended guidelines of moderate intensity exercises for MI.
16026343|NCT02693782|Dietary Supplement|Placebo|15 g/day maltodextrin in 3 portions of 5 g.
16026344|NCT02693782|Dietary Supplement|Fibre supplement|15 g/day Wheat Bran Extract in 3 portions of 5 g.
16026345|NCT02693769|Drug|fluticasone propionate/formoterol fumarate breath actuated inhaler|
16026346|NCT02693769|Drug|Indacaterol maleate / glycopyrronium bromide capsules|
16026347|NCT02693756|Other|Motor imagery|"The motor imagery intervention is a non-pharmacological and non-invasive treatment often used in sport, music, or physical rehabilitation (Schuster, Hilfiker et al. 2011). Proposed tasks to be imagined by the participants are for example:
~Imagine you are walking on ice. During the first steps, you are slipping quite often, but as you walk on, your steps become more stable and you walk without problems over the ice. Try to imagine how you react when you slip on ice, how you try not to fall and to continue to walk normally The motor imagery intervention will be performed independently by the study participants at home without supervision three times a week for three weeks."
16026348|NCT02693743|Device|repetitive transcranial magnetic stimulation (rTMS)|A Neurostar TMS Therapy System and Neurostar XPLOR coil system (Neuronetics, Malvern, Pennsylvania) will be used to deliver stimulation.
16026349|NCT02693717|Other|Laboratory Biomarker Analysis|Correlative studies
16026350|NCT02693717|Drug|Pemetrexed Disodium|Given IV
16127259|NCT01955720|Drug|BI 655075|
16026351|NCT02693704|Device|Hearing Aids|The only intervention consists in applying a specific processing on some recorded speech signals, and comparing the performance obtained with such processed samples with ones that have not been processed. The applied processing is a binaural spatialization method that consists in filtering an original audio signal to get a left and right versions (for the two ears). The binaural rendering gives the impression that the speech signal (and thus the speaker) is located in a desired position in the environment.
16026352|NCT02693691|Device|CardioMEMS HF System|Pulmonary Artery Pressure Monitoring
16026353|NCT02693678|Other|Massage|
16026354|NCT02693678|Device|DIathermy|
16026355|NCT02693678|Device|Sham diathermy|
16026356|NCT02693665|Behavioral|FAmily CEntered Advance Care Planning for Teens with Cancer|3 session weekly intervention: 1) survey completed by adolescent and family (surrogate decision maker) separately with facilitator; 2) Respecting Choices structured interview about patient's representation of illness, goals of care, hopes, treatment preferences; 3) completion of an advance directive.
16026357|NCT02693652|Biological|CVI-HBV-002|"Investigational product: CVI-HBV-002
~Dose: 20ug or 40ug
~Frequency: 3 or 6 times
~Vaccination schedule: 0, 1, 2 months or 0, 1, 2, 3, 4, 5 months
~Administration route: Intramuscular injection"
16026358|NCT02693626|Behavioral|intensive cessation message|Mobile phone-based text message （three to five messages per day） interventions ('Happy Quit') for smoking cessation for 12 weeks with 24 week follow up.
16026359|NCT02693626|Behavioral|Not intensive cessation message|Mobile phone-based text message （three to five messages per week） interventions ('Happy Quit') for smoking cessation for 12 weeks with 24 week follow up.
16026360|NCT02693613|Drug|ASP1517|Oral
16026361|NCT02693613|Drug|Kremezin®|Oral
16026362|NCT02693600|Procedure|Ligamentoplasty with partial trapeziectomy|
16026363|NCT02693600|Procedure|Ligamentoplasty with total trapeziectomy|
16026364|NCT02693587|Drug|Misodel and Angusta|
16026365|NCT02693574|Drug|Clarithromycin|
16026366|NCT02693574|Drug|Levofloxacin|
16026367|NCT02693561|Behavioral|Deep Breathing Exercises|Technical Deep Breathing: Deep breathing is to deep breath and slowly through the nostrils until total lung capacity. At the end of inspiration is kept a few seconds of apnea and started after the expiration slowly. End-expiratory apnea will remain a few seconds to start new inspiration cycle. With this process the individual breathe about 6 times per minute. Breath learning occurs through visual feedback. In the intervention group will be held deep breathing for 10 minutes. Subjects will be instructed to deep breath for 10 minutes 2 times a day for 15 days beyond the period in which they cleft, which is one of the symptoms of withdrawal syndrome. Control and frequency of deep breathing will be obtained weekly through specific daily fill, which will be provided weekly.
16026368|NCT02693561|Behavioral|Self-Help Book|Reading the self-help book.
16026387|NCT02693522|Drug|somatropin|Subcutaneous injection
16026388|NCT02693522|Drug|Eutropin|Subcutaneous injection
16026389|NCT02693509|Other|GWTG Heart Failure program|Evidence based guideline recommended therapies and counseling prior to hospital discharge
16026390|NCT02693496|Other|Installation or registration of smartphone application|Completed the installation and registration of mobile terminal software online
16026391|NCT02693483|Drug|10% povidone iodine|Vaginal cleansing will be done with 3 gauze pieces soaked with 10% povidone iodine in a sterilized bowl and the scrub will be done from the vaginal apex to introitus with attention to the anterior, posterior and lateral vaginal wall
16026392|NCT02693470|Drug|Ustekinumab|50 patients with severe psoriasis received ustekinumab 45mg at 0 and 1 month. There were 50 healthy controls. The levels of circulating CD31 and CD41a positive microparticles are measured. In patients with psoriasis, the investigators measure microparticles in the baseline and 4 months after ustekinumab. For control group, the investigators measure microparticles in the baseline.
16026393|NCT02693457|Procedure|Drain|One randomized knee will be assigned to receive an intra-articular drain procedure following bilateral total knee arthroplasty. The drain will be removed 24 hours post-operatively. The patient will be blinded to fluid output from intra-articular drain.
16026394|NCT02693457|Procedure|No Drain|The contralateral knee will be assigned to a placebo drain procedure following bilateral total knee arthroplasty. This will blind the patient as to which knee contains the functioning intra-articular drain. A non-suction/ non-functional subcutaneous drain will act as the placebo drain. This drain will not output any fluid and will also be removed 24 hours after post-operatively.
16026395|NCT02693444|Drug|Lidocaine|
16026396|NCT02693444|Drug|Saline|
16026397|NCT02693431|Other|Non interventional Study|"Parents and children will be informed at the inclusion visit (V0) that is a normal consultation under the care of the child.
~The children included will be followed for 18 months with a maximum of 6 months without meeting art therapy sessions and 12 months with art therapy. The art therapy sessions will be scheduled during the usual consultations conducted as part of the care of children.
~At each visit, clinical, paraclinical and external factors of anxiety will be collected and anxiety of parents and children will be measured using specific questionnaires."
16026398|NCT02693418|Drug|Acidform 5 g|Effect of 5 g vaginally administered Acidform on pH over 7 days
16026399|NCT02693418|Drug|Placebo 4 g|Effect of 4 g of vaginally administered HEC placebo gel on pH over 7 days
16026400|NCT02693418|Drug|Acidform 4 g|Effect of 4 g vaginally administered Acidform on pH over 7 days
16026405|NCT02693392|Drug|Oral hypoglycemic agents (pre-specified) [Metformin, Sulfonylurea]|"Patients receiving either of the following oral hypoglycemic agents
~Sulfonylurea based oral hypoglycemic agents
~Metformin based oral hypoglycemic agents
~Metformin plus Sulfonylurea based oral hypoglycemic agents"
16026406|NCT02693392|Dietary Supplement|Fenugreek Seed extract|Patients recruited in the study arm will receive Capsule Fenfuro 500 milligram twice daily for 12 weeks as add-on intervention to the pre-specified oral hypoglycemic agents therapy
16026407|NCT02693379|Device|D-VIA|"D-VIA images were captured during the cervical examination with a smartphone. Biopsies and cytological samples were taken on all patients and analyzed for gold standard results. Images were shown to off site experts. D-VIA and VIA diagnoses were then compared.
~Women who were diagnosed on-site as pathological underwent appropriate treatment at the same consultation. Women who were diagnosed as pathological later by histopathological analyses were asked to return to the clinic for treatment."
16026408|NCT02693366|Other|Bone marrow stem cell|Endovascular infusion of bone marrow derived cells in both renal arteries.
16026409|NCT02693340|Biological|sampling|"• Sampling period(s):
~Blood: W0, W6, W14, W30 and W52 and relapse.
~Biopsies and fecal: W0, W14 and M52 and relapse."
16026410|NCT02693327|Other|Biological Sample|A one time sample will be collected.
16026411|NCT02693327|Other|Blood Sample|A one time blood sample will be collected.
16026412|NCT02693314|Dietary Supplement|Jarro-Dophilus EPS® (5 billion CFU/capsule)|One capsule containing 5 billion CFU of the probiotic mix (Lactobacillus helveticus, Lactobacillus rhamnosus, Lactobacillus casei, Pediococcus acidilactici, Bifidobacteria breve, Bifidobacteria longum, Lactobacillus plantarum and Lactobacillus lactis ssp. lactis) will be taken once a day for a period of 28 days.
16026413|NCT02693314|Dietary Supplement|Jarro-Dophilus EPS® High Potency (25 billion CFU/capsule)|One capsule containing 25 billion CFU of the probiotic mix (Lactobacillus helveticus, Lactobacillus rhamnosus, Lactobacillus casei, Pediococcus acidilactici, Bifidobacteria breve, Bifidobacteria longum, Lactobacillus plantarum and Lactobacillus lactis ssp. lactis) will be taken once a day for a period of 28 days.
16026414|NCT02693314|Dietary Supplement|Placebo|One capsule (containing potato starch, magnesium stearate and ascorbic acid) will be taken once a day for a period of 28 days.
16026415|NCT02693301|Other|Exercise program|
16026416|NCT02693288|Procedure|Local infiltration anesthesia|Local infiltration by the surgeon at the end of surgery of perifracture site. A solution of 10 mL of ropivacaïne 0,75% is injected in the fracture site, tendon's synovial sheaths, subcutaneous tissue and skin.
16026417|NCT02693275|Device|Quotient® System iPad Test|See arm/group description
16026418|NCT02693262|Device|CLS Mode on Biotronik CRT-D|Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire.
16026419|NCT02693262|Device|Accelerometer Mode on Biotronik CRT-D|Setting changed and monitored. Quality of life evaluated through CPET, 6 Minute Walk Test, and Rand 36 Questionnaire.
16026420|NCT02693236|Biological|adenovirus-transfected autologous DC vaccine plus CIK cells|
16026421|NCT02693223|Other|GWTG Stroke program|Evidence based recommended therapies and counseling prior to hospital discharge.
16026422|NCT02693210|Drug|Cyclophosphamide|Participants will receive 750 mg infusions of cyclophosphamide on Days 3 and 17
16026423|NCT02693210|Drug|Methotrexate|Participants will receive >= 10 mg/week methotrexate orally up to 24 weeks
16026424|NCT02693210|Other|Placebo Cyclophosphamide|Participants will receive placebo in place of cyclophosphamide on Days 3 and 17
16026425|NCT02693210|Other|Placebo Methotrexate|Participants will receive weekly oral placebo in place of Methotrexate
16026426|NCT02693210|Other|Placebo Rituximab|Participants will receive placebo in place of rituximab on days 1 and 15
16026427|NCT02693210|Drug|Rituximab|Participants will receive 1g infusions of rituximab on Days 1 and 15
16026428|NCT02693197|Drug|T-817MA|A single oral dose of 448 mg
16026429|NCT02693184|Other|Full length Block 2014 Food Frequency Questionnaire|The food and beverage list includes 127 items, plus additional questions to adjust for fat, protein, carbohydrate, sugar, and whole grain content.
16026430|NCT02693184|Other|Revised Calcium, Vitamin D and Protein Screener|The food list includes 29 food items and 5 supplements
16026431|NCT02693171|Drug|Dinutuximab|Unituxin was administered along with cytokines according to the prescribing information
16026432|NCT02693145|Other|Anti-Retroviral Treatment and Access to Services (ARTAS)|Anti-Retroviral Treatment and Access to Services (ARTAS) is an individual-level, multi-session, time-limited intervention with the goal of linking recently diagnosed persons with HIV to medical care soon after receiving their positive test result. ARTAS is based on the Strengths-based Case Management (SBCM) model, which is rooted in Social Cognitive Theory (particularly self-efficacy) and Humanistic Psychology. SBCM is a model that encourages the client to identify and use personal strengths; create goals for himself/herself; and establish an effective, working relationship with the Linkage Coordinator (LC).
16026433|NCT02693132|Behavioral|Supervised (SUP-PA)|Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of supervised moderate-to-vigorous intensity physical activity.
16026434|NCT02693132|Behavioral|Unsupervised (UNSUP-PA)|Weight loss intervention that involves an energy restricted diet plus the inclusion of 150 minutes per week of unsupervised moderate-to-vigorous intensity physical activity.
16026435|NCT02693132|Behavioral|Step-based (STEP)|"Weight loss intervention that involves an energy restricted diet plus the inclusion of physical activity in the form of 10,000 steps/day with 2,500 brisk steps/day."
16026436|NCT02693119|Drug|elamipretide (MTP-131) 1% topical ophthalmic solution|
16026437|NCT02693119|Drug|Vehicle topical ophthalmic solution|
16026438|NCT02693106|Dietary Supplement|Control|Visit corresponding to a standardize breakfast taken alone (control visit) followed by a period of 4-hour with multiple blood sampling.
16026439|NCT02693106|Dietary Supplement|Leucine|Visit corresponding to a standardize breakfast with 5 g of leucine followed by a period of 4-hour with multiple blood sampling.
16026440|NCT02693106|Dietary Supplement|Butyrate -|Visit corresponding to a standardize breakfast with 3.6 g of butyrate followed by a period of 4-hour with multiple blood sampling.
16026441|NCT02693106|Dietary Supplement|Butyrate +|Visit corresponding to a standardize breakfast with 7.2 g of butyrate followed by a period of 4-hour with multiple blood sampling.
16026603|NCT02691663|Dietary Supplement|Oral bicarbonate supplementation|
16026442|NCT02693106|Dietary Supplement|Octanoate -|Visit corresponding to a standardize breakfast with 5 g of octanoate followed by a period of 4-hour with multiple blood sampling.
16026443|NCT02693106|Dietary Supplement|Octanoate +|Visit corresponding to a standardize breakfast with 10 g of octanoate followed by a period of 4-hour with multiple blood sampling.
16026444|NCT02693106|Dietary Supplement|Carnitine|Visit corresponding to a standardize breakfast with 1.95 g of carnitine followed by a period of 4-hour with multiple blood sampling.
16026445|NCT02693106|Dietary Supplement|Butter fraction|Visit corresponding to a standardize breakfast with 65 g of butter fraction followed by a period of 4-hour with multiple blood sampling.
16026446|NCT02693093|Drug|NI-03|
16026447|NCT02693093|Drug|Placebo|
16026448|NCT02693080|Device|CAPP-Seq|Cancer Personalized Profiling by Deep Sequencing (CAPP-Seq) is an assay which allows quantitative assessment of the levels of circulating-tumor DNA in the blood sample.
16026449|NCT02693080|Drug|Isovue-200|Contrast agent
16026450|NCT02693080|Radiation|Computed Tomography Perfusion Imaging|
16026451|NCT02693067|Drug|Rose bengal disodium|Percutaneous intralesional injection to NET tumor
16026452|NCT02693054|Device|HALO|Laser Treatment
16026453|NCT02693041|Drug|probiotic|Low-risk women, women with prior preeclampsia and women with a prior preterm birth will be randomized to be treated with LGG during pregnancy. Effect on maternal and perinatal outcome as well as the effect of treatment on immunological and inflammatory biomarkers will be evaluated.
16026454|NCT02693041|Drug|placebo|Low-risk women, women with prior preeclampsia and women with a prior preterm birth will be randomized to be treated with placebo during pregnancy. Effect on maternal and perinatal outcome as well as the effect of treatment on immunological and inflammatory biomarkers will be evaluated.
16026455|NCT02693028|Drug|Probiotic lozenges|The women participating in the study will take two probiotic lozenges per day (morning and evening) after meals.Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.
16026456|NCT02693028|Drug|Placebo lozenges|The women participating in the study will take two placebo lozenges per day (morning and evening) after meals. Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.
16026457|NCT02693028|Drug|Probiotic capsules|The women participating in the study will take two probiotic capsules per day (morning and evening) after meals. Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.
16026458|NCT02693028|Drug|Placebo capsules|The women participating in the study will take two placebo capsules per day (morning and evening) after meals. Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.
16026459|NCT02693028|Drug|Probiotic chewing gum|The women participating in the study will take two probiotic chewing gums per day (morning and evening) after meals. Enrollment will be done in gestational week 28-36. The treatment will last for the rest of pregnancy and six weeks post partum.
16026460|NCT02693002|Drug|Estradiol/Norethindrone acetate|Estradiol/Norethindrone acetate 1mg/0.5 mg
16026461|NCT02693002|Drug|Placebo|inactive ingredient
16026462|NCT02692989|Procedure|Hip fracture surgery and anesthesia|any operative fixation for hip fracture whether under General Anesthesia or Regional anesthesia
16026463|NCT02692976|Biological|mDC vaccination|Intranodal mDC vaccination
16026464|NCT02692976|Biological|pDC vaccination|Intranodal pDC vaccination
16026465|NCT02692976|Biological|mDC and pDC vaccination|Intranodal mDC/pDC vaccination
16026466|NCT02692963|Biological|BCG vaccination|BCG vaccine InterVax
16026467|NCT02692950|Other|Honor My Decisions Advance Care Planning Video|Honor My Decisions is a commercial computer application which allows a person to record a video of his/her advanced care planning and legacy information.
16026468|NCT02692950|Behavioral|Post-video questionnaire|Questions regarding the video process, changes to previous answers and reaction received by others viewing the video
16026469|NCT02692937|Procedure|Neurolysis|
16026470|NCT02692937|Other|Traditional neck-specific exercise program|
16026471|NCT02692859|Biological|Hib conjugate vaccine|Children aged 3-5 months: 3-dose(0,28,56 d);Children aged 6-11 months: 2-dose(0,28 d);Children aged 1-5 years:one dose(0 d), 0.5ml for each dose
16026472|NCT02692833|Other|No intervention|No intervention. This is an observational study of how patients' renal function responds to their surgery. The groups are defined by this response. There is no difference between clinical interventions between the two groups.
16026473|NCT02692820|Dietary Supplement|Probiotic|The probiotic capsule contains the two probiotics Lactobacillus rhamnosus GR-1 (GR-1) and Lactobacillus reuteri RC-14 (RC-14). The product contains freeze-dried bacteria and excipients in a gelatin capsule;
16026474|NCT02692820|Other|Placebo Comparator|The placebo contains excipients alone in a gelatin capsule
16026475|NCT02692807|Procedure|Arthroscopic surgical procedures|See arm/group description of Arthroscopic surgery and sham surgery (HIPARTI). HARP: only arthroscopic surgery
16026476|NCT02692781|Drug|MOD-6031|
16026477|NCT02692781|Other|Placebo control|
16026478|NCT02692768|Other|Live Music Therapy|Patients in this arm will meet with the music therapist to indicate preferences for one of three guided imagery scenarios to be included in their music-assisted relaxation routine. Patients will then receive live music relaxation and education for practice using a CD. Once admitted for surgery, patients will be seen immediately prior to going to the OR in the SDU, immediately following surgery in the PACU, and then within 12-24 hours of surgery on the inpatient floor. Pain and anxiety measures will be gathered at routine follow-up appointments following discharge (2 weeks and 6 months post-operatively).
16026479|NCT02692768|Other|Recorded Music Therapy|Patients in this arm will meet with the music therapist to indicate preferences for one of three guided imagery scenarios to be included in their music-assisted relaxation routine. Patients will then receive explanation for using the recorded routine on CD. Once admitted for surgery, patients will be seen immediately prior to going to the OR in the SDU, immediately following surgery in the PACU, and then within 12-24 hours of surgery on the inpatient floor. Pain and anxiety measures will be gathered at routine follow-up appointments following discharge (2 weeks and 6 months post-operatively).
16026604|NCT02691663|Dietary Supplement|Placebo|
16026700|NCT02690948|Drug|Vismodegib|Given PO
16026480|NCT02692768|Other|Control|Patients will receive standard of care without any music therapy intervention. These patients will have pain and anxiety measures taken at the same contact points as the music therapy intervention groups.
16026481|NCT02692755|Drug|Palbociclib + Letrozole or Fulvestrant|Palbociclib x 21 days with a 7 day rest plus 2.5 mg Letrozole QD (no break) or Fulvestrant 500mg IM every 2 weeks for 3 doses and then every 4 weeks until progression or maximum of 12 months
16026482|NCT02692742|Drug|Myelo001|Intake of study drug once daily per os for a maximum of 28 days in addition to Epirubicin and Cyclophosphamide treatment
16026483|NCT02692742|Drug|Placebo|Intake of study drug once daily per os for a maximum of 28 days in addition to Epirubicin and Cyclophosphamide treatment
16026484|NCT02692729|Procedure|transverse supraumbilical|transverse Supraumbilical Incision, in which the skin incision is a straight transverse skin incision slightly higher than the Pfannenstiel (5- 6) cm. from the upper border of the symphysis pubis The high transverse incision facilitated access to the fascia of the rectus abdominalis
16026485|NCT02692729|Procedure|pfannenstiel incision|Pfannenstiel Incision, in which the skin incision is a transverse upward concavity, typically initiated two finger-breadths above the symphysis pubis and extended in the direction of the anterior superior iliac spine below and medial to it about (2 - 3 ) cm.
16026486|NCT02692716|Drug|semaglutide|For oral use once daily.
16026487|NCT02692716|Drug|placebo|For oral use once daily.
16026488|NCT02692703|Drug|glecaprevir/pibrentasvir|Tablet; glecaprevir coformulated with pibrentasvir
16026489|NCT02692690|Device|Stimulette r4x|
16026490|NCT02692677|Drug|JNJ-42756493|Participants will receive a single oral solution at a dose of 12 milligram (mg) of unlabeled JNJ--42756493 admixed with 14C- labeled JNJ--42756493.
16026491|NCT02692664|Device|Endovascular aorto-iliac repair|
16026492|NCT02692651|Drug|Fidaxomicin|Eligible patients randomized to receive open-label Fidaxomicin will receive 200 mg twice daily for 10 days or until the end of the duration of concomitant antibiotics exposure, whichever is longer.
16026493|NCT02692651|Drug|Vancomycin|Eligible patients randomized to Vancomycin will receive 125 mg orally four times daily for 10 days or until the end of the duration of concomitant antibiotics exposure, whichever is longer.
16026494|NCT02692638|Procedure|Early laparoscopic enterolysis|The surgeon will make about 3-4 small incisions in the participant's abdomen. A port (nozzle) is inserted into one of the slits, and carbon dioxide gas inflates the abdomen. A laparoscope is inserted through another port. The laparoscope looks like a telescope with a light and camera on the end so the surgeon can see inside the abdomen. Surgical instruments are placed in the other small openings and used to cut the scar tissue in order to relieve the obstruction. After all this has been accomplished, the carbon dioxide is released out of the abdomen through the slits, and then these sites are closed with sutures or staples, or covered with glue-like bandage and steri-strips.
16026495|NCT02692638|Procedure|nonoperative management|Sometimes a bowel obstruction can be treated by suctioning out the contents of the stomach, giving IV fluids, and not letting the patient eat for a few days.
16026496|NCT02692625|Dietary Supplement|(L. reuteri Prodentis®).|The Test group is instructed to consume Probiotic lozenges for two months. The counts of salivary mutans streptococci and lactobacilli were evaluated using the CRT test at baseline, one-month, and two- months, from the beginning of the trial for every participating child.
16026497|NCT02692625|Dietary Supplement|Placebo lozenges|The control group is instructed to consume placebo lozenges for two months. The counts of salivary mutans streptococci and lactobacilli were evaluated using the CRT test at baseline, one-month, and two- months, from the beginning of the trial for every
16026498|NCT02692599|Biological|investigational live attenuated mumps vaccine|The investigational vaccine was manufactured by Sinovac (Dalian) Vaccine Technology Co., Ltd.
16026499|NCT02692599|Biological|control live attenuated mumps vaccine|The control vaccine was manufactured by Zhejiang VACN bio-pharmaceutical Co. Ltd.
16026500|NCT02692586|Device|FlowTriever System|
16026501|NCT02692573|Other|positioning|prone positioning for the initial 5 minutes of life
16026502|NCT02692573|Other|positioning|supine positioning for the initial 5 minutes of life
16026503|NCT02692560|Behavioral|I-STAND|Participants receive health coaching, a workbook, an inactivity alert wristband, and feedback charts based on objective measurement of sedentary time.
16026504|NCT02692560|Other|Healthy Living|Participants receive enhanced usual care based on general healthy living topics that are available to all Kaiser Permanente Washington enrollees.
16026505|NCT02692547|Device|Hybrid-logic closed loop system|All patients get to wear the pump
16026506|NCT02692534|Other|Urine cocaine negative|Preoperative urine cocaine negative
16026507|NCT02692534|Other|Urine cocaine positive|Preoperative urine cocaine positive
16026508|NCT02692521|Dietary Supplement|Human Milk|
16026509|NCT02692482|Device|hydrocellular polyurethane foam multilayer dressing|Application of hydrocellular polyurethane foam in the sacral region within 24 hours of admission and replaced when detaches or gets wet or dirty in addition to standard care
16026510|NCT02692482|Procedure|standard care|Standard care: PU risk assessment using the Braden scale within 24 hours of admission. Place patient on pressure mattress (static or alternating pressure) if Braden score <18, daily inspection of the skin in the various pressure points and moving the patient every 4 hours after surgery. Management of possible incontinence, humidity control and prevention of skin damage and rubbing/friction during postural changes as per hospital procedure.
16026511|NCT02692469|Procedure|Duodenal Switch|Bariatric procedure
16026512|NCT02692469|Procedure|Duodenal-ileal Bypass with Sleeve Gastrectomy|Bariatric procedure
16026513|NCT02692456|Device|Double needle celiac neurolysis (DNCN)|CT guided celiac neurolysis will be performed using 2 needles inserted on each sides of aorta where patient was positioned in prone position
16026514|NCT02692456|Device|Single needle celiac neurolysis (SNCN)|CT guided celiac neurolysis will be performed through advancing a single needle to justfront of the aorta near the origin of celiac trunk where patient placed in lateral position
16026515|NCT02692443|Device|Magnetic Resonance Imaging|Brain MRI without Contrast
16026516|NCT02692443|Behavioral|Neurodevelopmental Testing|Validated battery of neurodevelopmental and psychological tests.
16026517|NCT02692430|Other|No intervention is studied|
16026605|NCT02691598|Drug|Infusion|Dexmedetomidine Hydrochloride or normal saline 4ug/ml；0.05ml/kg.h infusion for 24hours
16026518|NCT02692417|Device|Transcutaneous Electrical Nerve Stimulation|Both arms will receive stimulation from the same TENS (transcutaneous electrical nerve stimulation) unit with identical stimulation frequency, but potentially different amplitudes depending on the subject's stimulation threshold.
16026519|NCT02692391|Drug|Indomethacin|Rectal indomethacin will be administered as 100 mg loading doses following by 5 maintenance doses of 50 mg at internals of 8 hours for total of 48 hours.
16026520|NCT02692391|Drug|Placebo|Glycerin placebo suppositories which are identical in shape, size, color, and packaging to rectal indomethacin
16026521|NCT02692378|Drug|sodium bicarbonate 500mg capsules|Defined by active substance and brand names not specified in protocol
16026522|NCT02692365|Procedure|Magnetic Resonance + hemodynamic + infusion of gadolinium|
16026523|NCT02692352|Other|Goal Management Training|Goal Management training, 8 sessions of 2 hours
16026524|NCT02692352|Other|Brain Health Workshop|Brain Health Workshop training, 8 sessions of 2 hours
16026525|NCT02692339|Drug|Lenalidomide|Standard of Care doses for relapsed/refractory multiple myeloma: 25 mg/day lenalidomide 21 of 28 days cycle
16026526|NCT02692339|Drug|Dexamethasone|Standard of Care doses for relapsed/refractory multiple myeloma: dexamethasone 40 mg/day at day 1,8,15,22 at 28 days cycle
16026527|NCT02692326|Procedure|Cyclic parenteral nutrition|Cyclic parenteral nutrition was provided according to a method described by Longhurst et al. Patients were initially cycled of PN for 1 hour per day with increased rate of 1 hour with a maximum time out of PN of 4 hours for preterm babies < 37 weeks GA and 6 hours for term newborns. Glucose was monitored at half the time without PN to detect the hypoglycemia.
16026528|NCT02692313|Drug|Epinephrine|Dose response of epinephrine infusion
16026529|NCT02692313|Other|Saline infusion|Placebo
16026530|NCT02692300|Procedure|EEG-Guided Group|Device: Bispectral Index (BIS) processed electroencephalogram or MASIMO or NeuroSENSE
16026531|NCT02692287|Device|The PPH Butterfly|The PPH Butterfly is a simple, low cost device that has been developed to facilitate less invasive compression of the uterus in a PPH
16026532|NCT02692261|Procedure|Maxillary Sinus Augmentation|Each 0.5 cc Collagenated Heterolog Bone Graft, mixed with two bundles of Hyalossᵀᴹ matrix and a few drops of sterile saline solution
16026533|NCT02692261|Procedure|Maxillary Sinus Augmentation|Control group sinuses filled with heterolog bone graft alone
16026534|NCT02692248|Drug|Ibrutinib|Ibrutinib 560 mg daily for 14 days during induction cycles. Maintenance phase: Continuous cycles until disease progression or unacceptable toxicity (maximum of 2 years).
16026535|NCT02692248|Drug|Rituximab|Rituximab 375 mg/m2 IV day 1 during 4 cycles.
16026536|NCT02692248|Drug|Gemcitabine|Gemcitabine 1000 mg/msq IV (30-minute infusion) on day 1 or 2, 4 cycles every 14 days.
16026537|NCT02692248|Drug|Oxaliplatin|Oxaliplatin 100 mg/msq (3-hour infusion) on day 1 or 2, after Gemcitabine infusion, 4 cycles every 14 days.
16026538|NCT02692248|Drug|Dexamethasone|Dexamethasone 20 mg orally or IV on day 1 and orally on days 2-3, 4 cycles every 14 days.
16026539|NCT02692235|Dietary Supplement|carnitine|1500 mg/d l-carnitine-l-tartrate
16026540|NCT02692235|Dietary Supplement|placebo|isonitrogenous
16026541|NCT02692222|Other|Calculation of PPV and CO with two methods|
16026542|NCT02692209|Device|FFDM Plus DBT|"FFDM + DBT Images
~FujiFilm Aspire Cristalle System"
16026543|NCT02692209|Device|FFDM Alone|FFDM Alone Images
16026544|NCT02692196|Device|Real-time fMRI neurofeedback from Turbo Brain voyager (TBV) 3.2|
16026545|NCT02692170|Biological|CVI-HBV-001|"Investigational product: CVI-HBV-001
~Dose: 5, 10, 20 or 40ug
~Frequency: 3 times
~Vaccination schedule: at 0, 1, 6 months
~Administration route: Intramuscular injection"
16026546|NCT02692170|Biological|Conventional Hepatitis B vaccine (20 μg)|"Active comparator: Conventional Hepatitis B vaccine (20 μg)
~Dose: 20ug
~Frequency: 3 times
~Vaccination schedule: at 0, 1, 6 months
~Administration route: Intramuscular injection"
16026547|NCT02692157|Drug|Placebo|Placebo for Neurokinin 1,3 antagonist
16026548|NCT02692157|Drug|NT-814 50 mg|Neurokinin 1,3 antagonist 50 mg
16026549|NCT02692157|Drug|NT-814 100 mg|Neurokinin 1,3 antagonist 100 mg
16026550|NCT02692157|Drug|NT-814 200 mg|Neurokinin 1,3 antagonist 200 mg
16026551|NCT02692144|Other|Test Cluster|Test cluster is an optimized savory cluster made through a proprietary baking process combined with slow digestible carbohydrates and fiber
16026552|NCT02692105|Radiation|Low dose rate prostate brachytherapy|Permanent implantation of radioactive Iodine-125 seeds under anesthesia with ultrasound guidance
16026553|NCT02692105|Radiation|High Dose Rate prostate brachytherapy|Temporary implantation of radioactive material into the prostate in the form of a stepping source of Iridium 192 that travels through 16-18 needles or catheters strategically placed through the prostate
16026554|NCT02692079|Procedure|T-PRF|Flap Surgery
16026555|NCT02692079|Procedure|Allograft|Flap Surgery
16026556|NCT02692066|Biological|varicella vaccine|
16026557|NCT02692053|Biological|blood sampling|additional blood sampling (volume: 18 mL)
16026558|NCT02692040|Drug|G3215|Gut hormone analogue
16026559|NCT02692040|Drug|Placebo|0.9% saline
16026560|NCT02692027|Other|Same-day ART initiation|"Participants tested HIV-positive during community-based HIV testing and randomized to the intervention group receive post-test counseling and on-the-spot clinical and laboratory assessment. Directly after the positive HIV-test result the study nurse assesses the participant clinically and performs point-of-care laboratory baseline testing. Thereafter, the participant receives a standardized short adherence counselling. After adherence counseling the participant is offered to start ART immediately. Those who decide to start ART during the visit or intend to start within seven days will receive a 30 day ART-supply and an follow-up appointment at the clinic within 12 to 16 days.
~In order to reduce travel time and transport cost, participants who are clinically stable, will have their follow-up visits and ART refills more widely spaced with appointments at 6 weeks, 3, 6, (9) and 12 months after ART initiation."
16026606|NCT02691585|Other|Music Intervention|A raga will be played for 10 minutes & data collected.
16026607|NCT02691572|Procedure|Spinal anesthesia|Performed at the L3-4 or L4-5 interspace using 27- or 25-gauge spinal needle.
16026608|NCT02691572|Drug|Intrathecal bupivacaine|Bupivacaine 12.5 mg will be administered in the subarachnoid space.
16026609|NCT02691572|Drug|Intrathecal fentanyl|Fentanyl 15 µg will be administered in the subarachnoid space.
16026561|NCT02692027|Other|Standard of care|"Individuals found HIV-positive during the community-based HIV testing campaigns and randomized to the control arm receive post-test counselling and a referral letter with an appointment at their chosen health facility. On the first visit to the clinic, the participant receives laboratory assessment and a first adherence counselling session. The participant must then return to the clinic to receive his/her laboratory results and to undergo a second adherence counselling session.
~Once the participant has started ART, the first and second follow-up visits are scheduled for 14 and 28 days after ART initiation, respectively. Thereafter, follow-up visits are scheduled monthly until 6 months after ART initiation. If the participant is clinically stable, clinical follow-up visits may then be spaced to 3-monthly intervals, but refills of ART must still be collected on a monthly basis."
16026562|NCT02692001|Other|Intervention MealTrain menu|"Nutrition education was incorporated using an interpretive traffic light system menu labeling. Dietitians categorized current menu items as green, yellow and red based on fiber, added sugar, saturated fats, and sodium content. A section entitled Eat like a superhero was created to prime children to consider what their potential role models choose, and incorporates descriptive names, suggest sample breakfast, lunch and dinner meals with photographs of portion sizes. Original cartoon female grapes and male broccoli superhero characters were created to employ promotional techniques specifically to promote fruits and vegetable selection for boys and girls."
16026563|NCT02691988|Other|ICS withdrawal|Bronchodilator therapy is optimized according to the latest COPD guideline of the Dutch College of General Practitioners (NHG) and inhaled corticosteroids are withdrawn.
16026564|NCT02691988|Other|Usual care|Bronchodilator therapy is optimized according to the latest COPD guideline of the Dutch College of General Practitioners (NHG)
16026565|NCT02691975|Drug|SHR3680|SHR3680 is administrated orally, qd, 28 days as one cycle. Patients may continue SHR3680 until disease progression or unacceptable toxicity.
16026567|NCT02691949|Drug|Mycophenolate mofetil|mycophenolate mofetil 1# BID-2# BID
16026568|NCT02691936|Device|CO2 fractionated vaginal laser|Intravaginal treatment with fractional microablative CO2 laser at baseline, 6 weeks and 3 months
16026569|NCT02691936|Drug|Estrogens, Conjugated (USP)|Conjugated estrogen cream 0.5g (equivalent of 0.625 mg of conjugated estrogen) daily for two weeks then twice weekly for 24 weeks
16026570|NCT02691923|Drug|Fluorescein|
16026571|NCT02691923|Drug|Fluorescein + ALA|
16026572|NCT02691910|Drug|Chloroquine|10mg/kg on day 0 and 7.5mg/kg on days 1 and 2. Total dose, 25 mg base/kg. Tablet containing 150mg of base.
16026573|NCT02691910|Drug|Primaquine|0.5 mg/kg once a day, for seven days. Total dose, 3.5mg/kg.
16026574|NCT02691897|Drug|Melatonin|Melatonin 3mg once daily at bedtime
16026575|NCT02691897|Drug|Placebo|Placebo 1 tablet once daily at bedtime
16026576|NCT02691884|Procedure|maternal abdominal pressure|The fetal cardiac response of either acceleration, deceleration or no change at all to the fetal heart- will be recorded and later on analyzed in reference to the amount of pressure applied from the 20th minute of CTG and for 5 minutes, using the FSR 400 sensor.
16026577|NCT02691871|Drug|Apatinib (250 mg/d) + Docetaxel (60 mg/m2)|
16026578|NCT02691871|Drug|Apatinib (500 mg/d) + Docetaxel (60 mg/m2)|
16026579|NCT02691871|Drug|Apatinib (750 mg/d) + Docetaxel (60 mg/m2)|
16026580|NCT02691858|Drug|Hydrocortisone|10 mg/kg with Resuscitation before attempting pneumatic reduction, single dose with Resuscitation before attempting reduction
16026581|NCT02691858|Drug|Saline|100 ml with Resuscitation before attempting pneumatic reduction, single dose with Resuscitation before attempting reduction
16026582|NCT02691845|Behavioral|BA (brief advice)|
16026583|NCT02691845|Behavioral|SHE (supervised and home-based exercise)|
16026584|NCT02691845|Behavioral|HE (health education)|
16026585|NCT02691845|Behavioral|CBEX (cognitive-behavioral sessions focused on increasing and maintaining exercise)|
16026586|NCT02691832|Device|"Dräger double sensor"|"The Dräger Double Sensor is a novel non-invasive device for assessing core body temperature."
16026587|NCT02691819|Device|single stent and embedded balloon angioplasty|
16026588|NCT02691806|Other|experimental protocol|"first day- VO2max test with the following measurements: anaerobic threshold, maximum oxygen consumption, heart rate and breathing indices.
~second day- performing the same physical protocol of VO2max test with the measurements: leg muscles activity using a wireless EMG, hemodynamic measurements of oxygen levels in the skin and skin perfusion, the two latest using optic sensors."
16026589|NCT02691793|Drug|Sunitinib|sunitinib 37.5mg QD
16026590|NCT02691780|Drug|Sorafenib|
16026591|NCT02691767|Drug|pazopanib|
16026592|NCT02691754|Other|free paracetamol|General Practitioners can prescribe paracetamol and the patient had to pick up the drug at the local hospital.
16026593|NCT02691741|Device|AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL|Trifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient
16026594|NCT02691741|Device|AT LISA® tri IOL|Trifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient
16026595|NCT02691728|Drug|LDV/SOF FDC|
16026596|NCT02691715|Procedure|Endometrial saline plus curettage|
16026597|NCT02691715|Procedure|Endometrial curettage|
16026598|NCT02691702|Drug|BIIB118|Multiple ascending doses of BIIB118 (50 mg, 150 mg, 450 mg and 900 mg) as extemporaneously prepared solution/suspension administered once daily over 2 weeks
16026599|NCT02691702|Drug|Melatonin|Positive control used to assess the validity of DLMO as pharmacodynamic endpoint.
16026600|NCT02691689|Other|Genetic testing|Genetic testing by DNA sequencing on blood samples after DNA extraction
16026601|NCT02691676|Drug|Plasmalyte|Parenteral administration of Plasmalyte initiated immediately after collection of the first blood sample at 166 mL/hour. Thus, all patients received 1000 mL of infusion solution over 6 hours.
16026602|NCT02691676|Drug|Ringerfundin|Parenteral administration of Ringerfundin initiated immediately after collection of the first blood sample at 166 mL/hour. Thus, all patients received 1000 mL of infusion solution over 6 hours.
16127601|NCT01953445|Drug|paclitaxel|
16026610|NCT02691572|Procedure|Cesarean delivery|Lower segment cesarean section using the Pfannenstiel incision and exteriorization of the uterus.
16026611|NCT02691572|Procedure|Wound infiltration|30 mL bupivacaine 0.25% will be injected subcutaneously in the surgical wound (15 mL on the upper and lower sides) by the obstetrician before skin suturing.
16026612|NCT02691572|Procedure|Sham procedure|Sham procedure will be performed after surgery by moving the ultrasound probe and pressing a covered spinal needle on both sides of the patients' abdomen.
16026613|NCT02691572|Procedure|Transversus abdominis plane block|Bilateral ultrasound-guided TAP block using 20 mL bupivacaine 0.25% on each side. A 7-12 MHz linear array probe and 22-gauge needle will be used. The probe will be placed transversely above the iliac crest in the anterior axillary line and the needle will be introduced in-plane with the probe from medial to lateral.
16026614|NCT02691572|Drug|Ketorolac|IV ketorolac 30 mg/8 h starting at the end of surgery.
16026615|NCT02691572|Drug|Paracetamol|Oral paracetamol 1 gm/8 h starting 4 h after surgery.
16026616|NCT02691572|Procedure|Fentanyl patient-controlled analgesia|Intravenous fentanyl: bolus dose = 20 µg, lockout interval = 7 min, 4-h dose limit = 200 µg, with no background infusion.
16026617|NCT02691559|Device|Amniotic fluid analysis by blood gas device|Amniotic fluid analysis by blood gas device in maternal inflammation group vs normal pregnancy group
16026618|NCT02691546|Other|blood sample collection|
16026619|NCT02691533|Drug|ω3 PUFA (Polyunsaturated fatty acids) (10% Omegavan 100 ml)|
16026620|NCT02691533|Drug|ω6 PUFA (Polyunsaturated fatty acids) (10% Intralipid 100 ml)|
16026621|NCT02691533|Drug|No Lipid Emulsion/Placebo|
16026622|NCT02691507|Device|EpiCeram Skin Barrier Emulsion|EpiCeram Skin Barrier Emulsion
16026623|NCT02691507|Drug|Experimental Product 1% Colloidal Oatmeal Balm|Experimental Product 1% Colloidal Oatmeal Balm
16026624|NCT02691494|Drug|Elagolix|Film-coated tablets
16026625|NCT02691494|Drug|Placebo for Estradiol/Norethindrone Acetate|Placebo capsules
16026626|NCT02691494|Drug|Estradiol/Norethindrone Acetate|Commercially-available E2/NETA tablets were over-encapsulated to maintain study blinding.
16026627|NCT02691494|Drug|Placebo for Elagolix|Film-coated placebo tablets
16026628|NCT02691481|Dietary Supplement|Oatmeal breakfast|
16026629|NCT02691481|Dietary Supplement|Glucerna formula|
16026630|NCT02691481|Dietary Supplement|Ultra Glucose Control formula|
16026631|NCT02691468|Device|PVC DLT|PVC DLT is type of double lumen tube that is composed of PVC
16026632|NCT02691468|Device|silicon DLT|silicon DLT is type of double lumen tube that is composed of silicon
16026633|NCT02691455|Device|Baerveldt Glaucoma Implant 350-mm2 / BG101-350|
16026634|NCT02691455|Procedure|Transscleral Diode Laser Cyclophotocoagulation|Recommended setting are 2000 milliwatt (mW) for 2 seconds, 1850 mW for 3 seconds or 1750 mW for 4 second duration, titrating the energy up or down just below where a pop is heard.
16026635|NCT02691455|Device|Ahmed Model FP7 Flexible Plate|
16026636|NCT02691455|Device|Baerveldt Glaucoma Implant 250-mm2 / BG103-250|
16026637|NCT02691442|Drug|Ropivacaine 0.75%|The investigators adminster 5ml of Ropivacaine 0.75% in an ultrasound-guided inter scalene nerve block
16026638|NCT02691442|Drug|Levobupivacaine 0.5%|The investigators adminster 5ml of Levobupivacaine 0.5% in an ultrasound-guided inter scalene nerve block
16026639|NCT02691442|Drug|Levobupivacaine 0.5% + epinephrin 1/200000|The investigators adminster 5ml of Levobupivacaine 0.5% + epinephrin 1/200000 in an ultrasound-guided inter scalene nerve block
16026640|NCT02691429|Other|Acai dye 10%|dye to be used during chromovitrectomy in humans
16026641|NCT02691416|Drug|propofol postconditioning|administrated Target Controlled Infusion(TCI) of propofol (Cp 1.2ug/ml) and decreased sevoflurane with a Bispectral index (BIS) value of 40-60 to maintain anesthesia after clamp removal
16026642|NCT02691416|Drug|sevoflurane|0.5%-2% sevoflurane with BIS 40-60
16026643|NCT02691403|Drug|levo-bupivacaine|
16026644|NCT02691403|Drug|normal saline|
16026645|NCT02691390|Device|Active dTMS|dTMS to ACC
16026646|NCT02691390|Device|Sham dTMS|SHAM - no stimulation
16026647|NCT02691377|Device|acupuncture group|Acupoints include 11 on the head, two on the upper extremities, and two on the lower extremities. Before performing acupuncture, a small pad will be pasted on each acupoint. All the needles will insert the acupoints through these pads. Then, they will be twirled, lifted and thrust three times to elicit the Deqi sensation. Each session will last 30 minutes.
16026648|NCT02691377|Device|Sham Acupuncture group|The same acupoints with acupuncture group are selected.A placebo needle with a blunt tip will be used to perform sham acupuncture. They will only insert the pad and no skin penetration. The same procedure with acupuncture group will be performed.
16026649|NCT02691364|Procedure|Blood withdrawal|
16026650|NCT02691351|Other|Prospective Registry|"Survival and disease status follow-up at 1st primary treatment, 1st salvage treatment and 2nd salvage treatment
~Regimen
~Response Evaluation
~SUSAR(Suspected, Unexpected, Serious, Adverse Reaction) collection"
16026651|NCT02691338|Other|EEG|EEG analysis
16026652|NCT02691338|Other|Routine follow up tests|Routine tests for patients after CVA. This include: neurologic evaluation, Brain CT, Angiography
16026653|NCT02691325|Drug|GSK2269557 ELLIPTA DPI|GSK2269557 ELLIPTA DPI contains GSK2269557 blended with lactose and magnesium stearate. This will be supplied in two strength of 100 mcg per blister.
16026654|NCT02691325|Drug|Placebo ELLIPTA DPI|Placebo ELLIPTA DPI contains lactose.
16026655|NCT02691325|Drug|Activated charcoal|The activated charcoal will be supplied by the clinical site. Charcoal will be administered as a suspension of 5 gram activated charcoal in 40 mL of water. The suspension will be made to drunk, in its entirety.
16026656|NCT02691312|Device|Digital Retinography System|The DRS is a portable non-mydriatic fundus camera in which children place their chin on a chin rest and the camera, after auto-focusing, takes photographs of their retinas. These photographs will be examined by an ophthalmologist (specializing in retinal disease) to assess for evidence of diabetic retinopathy.
16026657|NCT02691299|Drug|Fruquintinib|Fruquintinib is a capsule in the form of 5mg and 1mg, orally once daily. 3 weeks on/1 week off
16026658|NCT02691299|Drug|Placebo|Placebo is a capsule in the form of 5mg and 1mg, orally once daily. 3 weeks on/1 week off
16026659|NCT02691273|Behavioral|cellular application treating diabetes using breathing technique|
16026660|NCT02691260|Behavioral|incentives for dietary self-monitoring|Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application.
16026661|NCT02691260|Behavioral|incentives for interim weight loss|Participants will receive intermittent financial incentives for losing an expected amount of weight based weight obtained weekly.
16026662|NCT02691260|Behavioral|incentives for both|Participants will receive intermittent financial incentives for recording their dietary intake on a dietary mobile phone application and for losing an expected amount of weight based on weight obtained weekly.
16026663|NCT02691247|Biological|CLBS03 Low Dose|
16026664|NCT02691247|Biological|CLBS03 High Dose|
16026665|NCT02691247|Biological|Placebo|
16026666|NCT02691234|Device|Extracorporeal Shockwave Therapy and debridement|
16026667|NCT02691234|Other|debridement and cleaning|
16026668|NCT02691221|Behavioral|Relief Link Application Daily Tasks|Participants will complete daily mood tracking and completion of a minimum of one stress management activity per day. Relaxation exercises to choose from on the current version of RL are audio files (i.e., no visuals), and consist of: Guided Meditation, Energizing Breath, Guided Visualization for Relaxation, Progressive Relaxation, Mindfulness Meditation Body Scan, and Mindfulness of Breathing.
16026669|NCT02691208|Other|Kinesiotherapy|Standard therapeutic exercise, pre-defined, based on stretching the neck muscles, shoulder girdle and upper limb exercises for ADM lasting 30 minutes.
16026670|NCT02691208|Other|Acupuncture|Standard therapeutic exercise, pre-defined, based on stretching the neck muscles, shoulder girdle and upper limb exercises for ADM lasting 30 minutes plus 30 minutes of classical acupuncture using predefined points.
16026671|NCT02691195|Drug|Ropivacaine|patients were received an ultrasound-guided serratus plane block, the serratus plane was injected with 0.5% ropivacaine 0.4ml/Kg.
16026672|NCT02691195|Drug|0.9% Nacl|patients were received an ultrasound-guided serratus plane block, the serratus plane was injected with 0.9% Nacl 0.4ml/Kg.
16026673|NCT02691182|Drug|SPN-810|
16026674|NCT02691169|Drug|18F-DCFPyL|18F-DCFPyL is a sterile diagnostic radiopharmaceutical used for PET imaging.
16026675|NCT02691156|Diagnostic Test|Bilirubin Binding Capacity|Research laboratory assay of bilirubin binding capacity
16026676|NCT02691156|Diagnostic Test|End-tidal Carbon Monoxide|Noninvasive bedside test to measure exhaled end-tidal carbon monoxide levels for the detection of hemolysis
16026677|NCT02691156|Diagnostic Test|Carboxyhemoglobin|Laboratory assay of carboxyhemoglobin levels for the detection of hemolysis
16026678|NCT02691143|Other|TheraBand Kinesiology Tape|One approach to treating musculoskeletal conditions is a elastic therapeutic taping technique designed to target muscles and lymphatic system. Limited research on the efficacy of elastic therapeutic taping (ETT) is available for specific patient populations, including neck pain. ETT it is theorized to impact muscle function by inhibiting or facilitating the muscle, improve blood flow, reduce pain, and improve joint alignment. In a study by Gonzalez-Iglesias et al. the investigators reported that neck pain and range of motion significantly improved immediately and 24 hours after the application of ETT in acute whiplash patients as compared to a sham taping.
16026679|NCT02691130|Biological|Multimeric 001 (M-001)|Multimeric 001 is a recombinant protein comprising 9 conserved peptides from influenza A and B
16026680|NCT02691130|Biological|H5N1 influenza vaccine|Alum adjuvanted whole virion inactivated H5N1 vaccine produced by FluArt (Hungary)
16026681|NCT02691130|Biological|Saline|0.9% NaCl in double distilled water
16026682|NCT02691117|Drug|garlic concentrate|Topical application of GarlicRich gel on the scalp areas affected with alopecia areata once a day for 6 months
16026683|NCT02691104|Device|SMART COPD app to promote physical activity in COPD. Used in conjunction with a Fitbit Charge|An app which allows users to set physical activity goals, monitors progress towards those goals, and provides feedback to users. Several options for types of physical activity (daily walk, daily step count, and aerobic / strengthening exercises) which can be tailored to the individual user. Designed to be used in consultation with a physiotherapist initially, and then used independently by the individual with COPD. The app will first be used alongside pulmonary rehabilitation (PR), with physiotherapist advice on exercises and setting goals. After PR the individual with COPD will receive weekly contact from a physiotherapist for the first 4 weeks, and then no contact for the second 4 weeks
16026684|NCT02691104|Device|Control|Participants will follow the (usual care) PR programme. They will be asked to wear a blinided (cannot see step count) Fitbit Charge during the time they are on PR and then for 8 weeks afterwards
16026685|NCT02691078|Other|99m Tc - HYNIC -TOC EDDA and 111In - DTPA-octreotide|The patient will undercome an PET/CT exam with 99m Tc - HYNIC -TOC EDDA, after 20 days of wash out, the same patient will undercome the same exam with 111In - DTPA-octreotide in order to compare both radiopharmaceuticals
16026686|NCT02691065|Drug|Integrase Inhibitor|
16026687|NCT02691052|Other|Quality of Life questionnaire|EORTC QLQ-C30 questionnaire
16026688|NCT02691026|Drug|Pembrolizumab|
16026689|NCT02691013|Drug|Ramelteon|
16026690|NCT02691013|Drug|Placebo|
16026691|NCT02691000|Device|LiteBook|Light therapy using a Bright White Light Litebook for 1 hour each morning for 8 weeks. This is the experimental intervention.
16026692|NCT02691000|Device|LiteBook|Light therapy using a Dim Red Light Litebook for 1 hour each morning for 8 weeks. This is the control.
16026693|NCT02690987|Drug|Exenatide|"Exenatide is a commercially available GLP-1 receptor agonist. It is a synthetic form of exendin-4, a protein extracted from the saliva of a Gila monster lizard, which exhibits 53% sequence identity to human GLP-1.
~The planned intravenous Exenatide infusion dose is expected to be 0.06 pmol/kg/min aiming for maintenance plasma concentrations of ~130-190 pg/mL."
16026694|NCT02690987|Biological|Desacyl ghrelin|"Ghrelin is a 28 amino acid stomach-derived peptide hormone, with the desacyl ghrelin (DAG) form inactive at the GHSR1a receptor. Good Manufacturing Practice (GMP)-grade DAG is obtained from Clinalfa (Bachem AG, Bubendorf, Switzerland).
~The planned intravenous DAG infusion dose is expected to be 4.0 mcg/kg/hour aiming for maintenance plasma concentrations of ~13-19 ng/mL."
16026695|NCT02690987|Biological|Saline|The placebo visit will involve an intravenous infusion of normal saline.
16026696|NCT02690974|Drug|LCZ696 (sacubitril/valsartan)|All patients were treated with the LCZ696 (sacubitril and valsartan) tablets
16026697|NCT02690961|Drug|Kukoamine B Mesilate|Kukoamine B Mesilate or placebo single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.
16026701|NCT02690935|Drug|2LALERG|Homeopathic drug
16026702|NCT02690935|Drug|Placebo|Placebo
16026703|NCT02690922|Drug|Dasatinib|100mg (d1-d84)
16026704|NCT02690922|Drug|prednisone|60mg/m2 d1-24
16026705|NCT02690922|Drug|dexamethasone|10mg/d 3-7days
16026706|NCT02690922|Drug|methotrexate|3g/m2 1day
16026707|NCT02690909|Device|Redy™ Renal Denervation System|Renal Denervation System
16026708|NCT02690896|Behavioral|UCF Caregiver Support Group|The intervention will be a 90 minute group session, once a week, for a period of 6 consecutive weeks. The intervention will teach caregivers specific behavioral techniques for managing care recipients' symptoms in the home environment and encourage caregiver self-care.
16026709|NCT02690896|Behavioral|Community Support Groups|Comparison group members will come from local community support groups, which typically include components of social support and limited psychoeducation, and are relatively unstructured.
16026710|NCT02690883|Drug|Exenatide|Exenatide (Astrazeneca ) 5 μg(initial dose)/10ug(maintenance dose) Subcutaneous injection Bid
16026711|NCT02690883|Drug|Lispro|Lispro (Eli Lilly), the dosage is initiated according to the previous treatment plan and weight of the patients, distribute the dosage to 1:1:1 before 3 meals, titration following PPG <10.0mmol/L.
16026712|NCT02690870|Drug|Tamoxifen|Patients in the tamoxifen group will take 20 mg of tamoxifen oral tablets daily from day 3 of the menses for 5 days.
16026713|NCT02690870|Drug|Clomiphene|Patients in clomiphene group will take 100 mg of CC oral tablets daily from day 3 of the menses for 5 days.
16026714|NCT02690857|Drug|Docosahexaenoic acid|
16026715|NCT02690857|Drug|Sunflower Oil|
16026716|NCT02690844|Drug|Clonazepam mixed with Mucolox®|1mg clonazepam in 5mL Mucolox® will be used TID. Mixture will be swished around mouth for 3 minutes then spat out.
16026717|NCT02690844|Drug|Mucolox® alone|5mL Mucolox® TID. Mixture swished around mouth for 3 minutes then spat out.
16026718|NCT02690844|Drug|Clonazepam|1mg Clonazepam tablet will be used TID. Tablet dissolved in mouth, swished around and then expectorated.
16026719|NCT02690831|Other|Inspiratory Muscle training (IMT)|Inspiratory Muscle training This protocol will be performed using the Powerbreathe classic level 1 device and Yoga Respiratory Exercises (Pranayama)
16026720|NCT02690831|Other|IMT + Manual Therapy and Motor Control Exercise|IMT + Manual Therapy and Motor Control Exercise The Inspiratory Muscle Training protocol will be performed using the Powerbreathe classic level 1 device and Yoga Respiratory Exercises (Pranayama). Manual Therapy and Motor Control Exercises will consist of joint mobilization/manipulation and exercises in the neck and thoracic regions
16026721|NCT02690831|Device|Powerbreathe|
16026722|NCT02690818|Behavioral|Regularly scheduled LTBI medication reminder text messages|"Regularly scheduled medication reminder text messages Daily LTBI text messages without the option to text back. The messages will read, This is a reminder to take your medication."
16026723|NCT02690805|Device|MR-compatible scinti-mammography (MRI-SMM) system|
16026724|NCT02690792|Other|NAFLD/NASH - Placebo|Placebo capsules, 2 capsules by mouth each morning and 2 capsules by mouth each evening for 4 months.
16026725|NCT02690792|Dietary Supplement|NAFLD/NASH - Vitamin E|Vitamin E 200 IU capsule, 2 capsules by mouth each morning and 2 capsules by mouth each evening for 4 months.
16026726|NCT02690779|Other|Educational intervention|2-3 minute video demonstrating video images of adequate and inadequate bowel preps, and reviewing instructions for split dose prep administration.
16026727|NCT02690779|Other|Routine Care Instructions|patients will follow routine care and instructions
16026728|NCT02690766|Behavioral|Standard Behavioral Weight Change Intervention|Participants enrolled in Phase 2 of the study will meet once a month for 75 minutes over the course of 4 months. Within this 75 minutes, they will complete 25 minutes of physical activity with a licensed physical activity instructor that is very experienced with working with this population, review and discuss various topics/lessons that relate to diabetes, nutrition, survivorship and physical activity with the study's interventionist and Group Leader
16026729|NCT02690753|Procedure|A protocol tailored to individual risk factors|
16026730|NCT02690753|Device|The Prevalon® Turn and Position System 2.0|
16026731|NCT02690753|Device|Comfort Shield® barrier cream cloths|
16026732|NCT02690740|Other|(diagnostic) conjunctival provocation test with solution: ALK 100, 1.000, 10.000, 20.000, 50.000 and 100.000 SQ-U/ml|"see information in arm/group descriptions"
16026733|NCT02690727|Drug|RP6530|Single oral dose
16026734|NCT02690714|Biological|Plasminogen (Human) intravenous|Prometic Plasminogen (Human) intravenous infusion given as single dose of 6.6 mg/kg in Segment 1 and repeat doses in Segments 2 and 3.
16026735|NCT02690701|Drug|Secukinumab 300 mg|"Secukinumab 300 mg was provided in 1 mL prefilled syringes of 150 mg. Each dose of 300 mg secukinumab consisted of two secukinumab 150 mg injections once weekly for 5 weeks (Baseline, Weeks 1, 2, 3 and 4), followed by dosing every four weeks starting at Week 8 through Week 48 inclusive.
~The patients (or caregivers) self-injected each dose at the study site under the supervision of site personnel when injections occurred on days of study visits.
~The injections not occurring on days of study visits were done by the patients (or caregivers) at home."
16026736|NCT02690701|Biological|Placebo|"Placebo was provided in 1 mL prefilled syringe. Each placebo dose consisted of two placebo injections once weekly for five weeks (Baseline, Weeks 1, 2, 3, 4), then after four weeks at Week 8. At Week 12, patients were switched to receive 300 mg secukinumab once weekly for five weeks (Weeks 12, 13, 14, 15, 16) followed by monthly dosing through Week 48 inclusive.
~The patients (or caregivers) self-injected each dose at the study site under the supervision of site personnel when injections occured on days of study visits.
~The injections not occurring on days of study visits were done by the patients (or caregivers) at home."
16026737|NCT02690688|Device|determination of dynamic preload variables|
16026738|NCT02690675|Dietary Supplement|Iron fortified formula milk|One group received formula milk fortified with 1.2 mg/100 mL and the other group 0.4 mg/100mL between 6 and 12 months of age.
16026739|NCT02690662|Behavioral|Hypocaloric diet|recommendation of daily ingestion of 2500 ml of water and low-calorie diet of 16 Kcal/kg bw/day
16026741|NCT02690636|Radiation|radiotherapy|daily fractions, five fractions per week.
16026742|NCT02690623|Other|Pediatric hospitalist program|In-house hospitalists available at all hours
16026743|NCT02690623|Other|General Pediatric Inpatient Services|Inpatient care by general pediatrics faculty
16026744|NCT02690610|Procedure|EBUS TBNA of mediastinal lesions or lymph nodes|Through endo-bronchial ultrasound, a transbronchial needle will be introduced to take biopsies from mediastinal lesions under ultrasonic guidance.
16026745|NCT02690597|Other|Anxiety visual analog scale|Anxiety visual analog scale is a test of evaluation of anxiety done by the patient, this scale do not include number and the patient have to place a coloured marker at the level indicating his anxiety feeling
16026746|NCT02690584|Behavioral|Metacognitive therapy|
16026747|NCT02690571|Other|Bronchoscopy|The bronchoscopy procedure was performed six hours after completion of the exposure session, with sampling of endobronchial mucosal biopsies, bronchial wash and bronchoalveolar lavage performed under topical anaesthesia.
16026749|NCT02690545|Biological|ATLCAR.CD30 cells|For Phase Ib, in adults and separately in children, two doses will be investigated: 1x10^8 cells/m^2 and 2x10^8 cells/m^2. Phase II patients will receive the dose level decided upon in Phase I.
16026750|NCT02690519|Drug|GLPG1837 dose 1|one GLPG1837 tablet in the morning and one GLPG1837 tablet in the evening, for 2 weeks
16026751|NCT02690519|Drug|GLPG1837 dose 2|one GLPG1837 tablet in the morning and one GLPG1837 tablet in the evening, for 2 weeks
16026752|NCT02690506|Drug|Placebo|
16026753|NCT02690506|Drug|Pregabalin|
16026754|NCT02690493|Procedure|Acupuncture|Acupuncture needles are inserted in specific acupuncture points on the boby (three points on both forearms and five points on the top of the head) for twenty minutes, three times a week, during twelve sessions.
16026755|NCT02690493|Other|Functional Taping|Elastic taping is positioned directly on the skin (on the back of the fingers, hand, forearm and arm - paretic upper limb), three times a week, during twelve sessions. The patient should keep the taping on the skin for two days.
16026756|NCT02690493|Other|Acupuncture and Functional Taping|Acupuncture needles are inserted in specific acupuncture points on the boby (three points on both forearms and five points on the top of the head) for twenty minutes, then elastic taping is positioned directly on skin (on the back of the fingers, hand, forearm and arm - paretic upper limb). Both procedures are performed three times a week, during twelve sessions.
16026757|NCT02690480|Drug|PD-0332991 (Palbociclib)|"Palbociclib, 125 mg, orally once daily from day 1 to day 21 followed by 7 days off treatment on every 28 days cycles.
~Patients will continue to receive their assigned treatment until objective disease progression, clinical progression (under investigator criteria), unacceptable toxicity, death or withdrawal of consent, whichever occurs first"
16026758|NCT02690480|Drug|Fulvestrant|"Fulvestrant 500mg, two 5ml intramuscular injections (one in each buttock), on days 1, 15 (±3 days) of Cycle 1, and then on Day 1 of each subsequent 28 day cycle (±3 days)
~Patients will continue to receive their assigned treatment until objective disease progression, clinical progression (under investigator criteria), unacceptable toxicity, death or withdrawal of consent, whichever occurs first"
16026759|NCT02690480|Drug|Placebo|"Placebo orally once daily from day 1 to day 21 followed by 7 days off treatment on every 28 days cycles.
~Patients will continue to receive their assigned treatment until objective disease progression, clinical progression (under investigator criteria), unacceptable toxicity, death or withdrawal of consent, whichever occurs firs"
16026760|NCT02690467|Device|Insupen G34x3,5mm|
16026761|NCT02690467|Device|Insupen G32x4mm|
16026762|NCT02690441|Behavioral|Cognitive Behavioural Therapy|Cognitive behavioural therapy conducted individually. 10 weekly sessions, first session lasts 90 minutes, the remaining sessions last 45 minutes.
16026763|NCT02690441|Behavioral|Physical Exercise|Manualised exercise. 15 weekly sessions with instructor, and two weekly unsupervised sessions performed individually.
16026764|NCT02690441|Behavioral|Placebo control|One follow-up telephone call à 15 minutes each week for 15 weeks. Aims to control for therapist contact in physical exercise condition and total duration of treatment.
16026765|NCT02690428|Device|Immunostimulating Interstitial Laser Thermotherapy|Immunostimulating Interstitial Laser Thermotherapy (imILT) is a specific form of thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a tumor specific immunologic response.
16026766|NCT02690415|Procedure|Antibiotics Given|Patients who's treating physician prescribed antibiotics
16026767|NCT02690415|Procedure|Antibiotics not given|Patients who's treating physician did not prescribed antibiotics
16026768|NCT02690402|Behavioral|adapted physical activity|The study begins with an evaluation of physical strenght and cognitive and psychometric assessment.Then, a personalized care will be offered in terms of adapted physical activity. The evaluation protocol will be performed again to measure the impact of physical activity three months after the first assessment.
16026769|NCT02690389|Drug|Flumazenil|used alone or with acupuncture
16026770|NCT02690389|Procedure|Acupuncture|used alone or with flumazenil
16026771|NCT02690376|Device|Magnetic Assisted Capsule Endoscopy|Swallowed magnetic capsule for endoscopy purposes
16026772|NCT02690350|Drug|U3-1784|Solution for solution in 5% dextrose for infusion, intravenously administered every 2 weeks (q2w) as a 250 mL IV, along with colestyramine or equivalent if clinically indicated
16026773|NCT02690337|Drug|DS-1123|starting intravenous (IV) dose of 0.1 mg/kg.
16026774|NCT02690324|Behavioral|cognitive stress (serial 7)|
16026775|NCT02690311|Device|smartphone display|
16026776|NCT02690298|Device|ExSpiron|Non-Invasive respiratory volume monitoring
16026777|NCT02690285|Drug|Dichloroacetate (DCA)|Dichloroacetate (DCA) 25 mg/kg oral solution will be administered daily for 5 days.
16026778|NCT02690285|Other|GSTZ1 haplotyping|One teaspoon of blood is collected by standard phlebotomy. Cheek cells are collected by standard brushing. Samples will be analyzed at two independent laboratories to validate methods for GSTZ1 haplotype analysis.
16026779|NCT02690272|Behavioral|Psychic processes|Quantitative and qualitative aprroche of the psychic process
16026780|NCT02690259|Procedure|Sentinel node procedure|Patients with Endometrial cancer undergo Sentinel node procedure using Indocyanine green
16127602|NCT01953445|Drug|BKM120|
16026781|NCT02690246|Other|questionnaire|a questionnaire based study
16026782|NCT02690233|Procedure|Elective Surgery|Elective laparoscopic inguinal hernia repair
16026783|NCT02690220|Device|TiLOOP® PRO Plus A|The standard operation method for the surgical repair of anterior prolapse is via the obturator membrane. The mesh is placed trans-vaginally using the TiLOOP® Application Set to place the mesh arms.
16026784|NCT02690207|Biological|Herpes Zoster Vaccine GSK1437173A|Intramuscular injection
16026785|NCT02690194|Device|Placebo Group|The placebo group will wear headphones and listen to nature sounds.
16026786|NCT02690194|Device|Buddhify Therapy|The experimental group will complete a Buddhify relaxation therapy session, before their injection. This therapy consists of wearing headphones and listening to guided meditation instructions.
16026787|NCT02690181|Biological|GBS Trivalent Vaccine|Administration of lyophilized formulation of a GBS trivalent vaccine containing 5 µg of each polysaccharide capsules from serotypes Ia, Ib, and III of Group B Streptococcus conjugated to CRM-197 .
16026788|NCT02690168|Behavioral|Fasting|72 hour fasting
16026789|NCT02690155|Drug|Rivaroxaban (Xarelto, BAY59-7939)|As prescribed by treating physicians
16026790|NCT02690155|Drug|VKA (Vitamin K antagonist)|As prescribed by treating physicians
16026791|NCT02690142|Drug|Placebo|Single dose i.v.
16026792|NCT02690142|Drug|ABY-035 i.v.|Single dose i.v.
16026793|NCT02690142|Drug|ABY-035 s.c.|Single dose s.c.
16026794|NCT02690129|Drug|Vaginal Progesteron|
16026795|NCT02690116|Other|Qigong/Tai Chi Easy|Classes will be at two different times of day (to accommodate working and non-working participants). Participants will attend one 60 minute class per week for the 8 weeks, with a recommended home practice time of 2 1/2 hours each week.
16026796|NCT02690116|Other|Sham Qigong|Classes will be at two different times of day (to accommodate working and non-working participants). Participants will attend one 60 minute class per week for the 8 weeks, with a recommended home practice time of 2 1/2 hours each week.
16026797|NCT02690116|Other|Educational Support|Class times and at-home readings correspond to dose set for the QG/TCE and SQG class times and home practice. Participants will attend one 60-minute class per week for the 8 weeks, with a recommended home practice time (reading, workbook completion) of 2 1/2 hours each week.
16026798|NCT02690103|Drug|pegylated IFN|Patients are treated with 180µg of pegylated IFN (Pegasys-Roche) subcutaneously weekly for three months.
16026799|NCT02690103|Dietary Supplement|Biobran|Biobran, at a dose of 1g per day, allocated in packets, taken orally with meals for the three months duration of the study. Biobran is a denatured hemicellulose that is obtained by reacting rice bran hemicellulose with multiple carbohydrate hydrolyzing enzymes from Shiitake mushrooms. It is a polysaccharide that contains ß-1, 3-glucans, and activated hemicellulose. Biobran was kindly provided by Daiwa Pharmaceuticals Co. Ltd., Tokyo, Japan.
16026800|NCT02690103|Drug|Ribavirin|Ribavirin is prescribed according to patients body weight (1200 mg for those over 75 kg and 1000 mg for those under 75 kg).
16026801|NCT02690077|Procedure|Family-Centered Cesarean|Procedure involves lowering part of the surgical drape exposing a transparent window through which the mother can watch the birth of her baby; the baby will be placed on her chest immediately after the delivery. Cleaning and evaluation of the baby will be done by a nurse who is standing at the head of the bed.
16026802|NCT02690077|Procedure|Traditional Cesarean|Procedure involves keeping the surgical drape up throughout the entire surgery so that the birthing process will not be visible to the mother, and the baby will be taken to the warmer to be evaluated and cleaned after birth but is available to be laid on the mother's chest at any point upon request.
16026803|NCT02690064|Dietary Supplement|Acute Antioxidant|Flow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment
16026804|NCT02690064|Dietary Supplement|Chronic Antioxidant|Flow-Mediated Dilation will be determined at baseline, week 4, week 8, and week 12.
16026805|NCT02690064|Other|Placebo|Flow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment
16026806|NCT02690051|Device|BeSmooth peripheral stent|patients treated with the BeSmooth Peripheral Stent System
16026807|NCT02690038|Drug|Intravenous immunoglobulin (IVIG)|"Baseline Ig < 7g/L group - Intravenous immunoglobulin (IVIG) 0.8 g/kg will be given within 12 hours after randomization.
~Baseline Ig > or = 7 g/L group - Intravenous immunoglobulin (IVIG) 0.5 g/kg will be given within 12 hours after randomization"
16026808|NCT02690038|Drug|Normal Saline|"Baseline Ig < 7g/L group - Normal Saline (0.9% NaCl) 8 mL/kg will be given within 12 hours after randomization.
~Baseline Ig > or = 7 g/L group - Normal Saline (0.9% NaCl) 5 mL/kg will be given within 12 hours after randomization"
16026809|NCT02690025|Drug|ZP1848|
16026810|NCT02690012|Other|Magnesium Oxide|Magnesium Oxide
16026811|NCT02690012|Other|Magnesium Citrate|Magnesium Citrate
16026812|NCT02689999|Drug|Dexrabeprazole 10 mg Enteric-Coated Tablets|
16026813|NCT02689986|Drug|Bendamustine, Rituximab|Bendamustine, Rituximab
16026814|NCT02689973|Behavioral|Self-Efficacy|"The introductory part included an abbreviated version of the education materials used in the control group. The self-efficacy materials and forms had four sections: (a) definitions of self-efficacy beliefs, (b) information on the importance of self-efficacy for goal pursuit, (c) recollecting a mastery experience, (d) persuasive statements evoking self-persuasive statements about self-efficacy beliefs. The materials ended with instructions for the following 7 days to recollect self-efficacy enhancing statements every morning. The procedures are based on a self-efficacy intervention by Luszczynska, Tryburcy et al. (2007).
~Group and individual components were included. Setting: secondary and high schools."
16026815|NCT02689973|Behavioral|Planning|"The introductory part included an abbreviated version of the education materials used in the control group. The planning materials and forms had four sections: (a) information on the importance of planning, including examples of how planning works and what it affects, (b) instructions of what should be included in a good plan (the when, where, and how components), (c) formulating action and coping plans. The materials ended with instructions for the following 7 days to recollect/redo plans every morning.The procedures are based on a planning intervention by Luszczynska, Sobczyk, et al. (2007).
~Group and individual components were included. Setting: secondary and high schools."
16026863|NCT02689622|Other|physical performance|Activities of Daily Living and physical performance
16027037|NCT02688426|Device|6J Low-Level Laser Therapy (6J LLLT)|irradiation will be perform with 6J
16026816|NCT02689973|Behavioral|Education|"Participants received a set of educational materials about types of physical activity (PA), PA intensity, exercise calorie expenditure, myths about PA, strength and endurance training, stretching, and general healthy nutrition guidelines. The materials excluded planning and self-efficacy statements.
~The materials ended with instructions for the following 7 days to recollect forms of MVPA every morning.
~Group and individual components were included. Setting: secondary and high schools."
16026817|NCT02689960|Drug|100mg prednisone suppository|vaginal administration of 100mg prednisone suppository (Rectodelt)
16026818|NCT02689947|Device|Restylane Silk|
16026819|NCT02689934|Dietary Supplement|Lactoflorene colesterolo|1.8 g + 1.8 g once a day per os
16026820|NCT02689934|Dietary Supplement|Placebo lactoflorene colesterolo|1.8 g + 1.8 g once a day per os
16026821|NCT02689921|Drug|Exemestane|Aromatase inhibitor
16026822|NCT02689921|Drug|Letrozole|Aromatase inhibitor
16026823|NCT02689921|Drug|Anastrozole|Aromatase inhibitor
16026824|NCT02689921|Drug|Leuprolide Acetate|Luteinizing Hormone-Releasing Hormone agonist
16026825|NCT02689921|Drug|Pertuzumab|Monoclonal antibody (HER2/neu receptor antagonist)
16026826|NCT02689921|Drug|Trastuzumab|Monoclonal antibody (HER2/neu receptor antagonist)
16026827|NCT02689908|Radiation|computed tomography|low dose protocol of thorax ct
16026828|NCT02689895|Other|modified directly administered anti-retroviral therapy (mDAART)|As described before
16026829|NCT02689882|Dietary Supplement|nicotinamide riboside|Nicotinamide riboside dose up-titration: Days 1 and 2: 250 mg by mouth daily; Days 3 and 4: 250 mg by mouth twice daily; Days 5 and 6: 500 mg by mouth twice daily; Days 7 and 8: 1000mg by mouth twice daily; Day 9: single dose of 1000mg by mouth followed by 24 hour pharmacokinetic study.
16026830|NCT02689869|Drug|Ibrutinib|Ibrutinib (PCI-32765; JNJ-54179060) is a first-in-class, potent, orally-administered covalently-binding small molecule inhibitor of Bruton's tyrosine kinase currently being co-developed by Janssen Research & Development, LLC and Pharmacyclics, Inc for the treatment of B-cell malignancies.
16026831|NCT02689869|Drug|GA 101|Obinutuzumab (GA 101) is a first-in-class, potent, intravenously administered type II anti-CD 20 antibody that is developed by Roche AG for the treatment of B-cell malignancies.
16026832|NCT02689856|Drug|Hydrocortisone acetate and lidocaine hydrochloride|Hydrocortisone and lidocaine in combination
16026833|NCT02689856|Drug|Placebo control|Vehicle cream alone
16026834|NCT02689856|Drug|Hydrocortisone acetate|hydrocortisone alone
16026835|NCT02689856|Drug|Lidocaine hydrochloride|lidocaine alone
16026836|NCT02689843|Drug|Cyproterone compound + Spironolactone|Cyproterone compound (Cyproterone Acetate 2mg-Ethinyl estradiol 35mcg) 1 tablet daily + Spironolactone 50 mg twice daily
16026837|NCT02689843|Drug|Metformin|Metformin 500mg three times daily
16026838|NCT02689843|Drug|Pioglitazone|Pioglitazone 30mg once daily
16026839|NCT02689830|Device|Bead Block|Prostate embolization
16026840|NCT02689817|Device|Patch|A bandage applied to the sacrum with pressure offloading characteristics and pressure monitoring components in a low-profile housing.
16026841|NCT02689804|Drug|LNG-EC|FDA-approved emergency contraceptive pill containing levonorgestrel 1.5mg
16026842|NCT02689804|Drug|UPA-EC|FDA-approved emergency contraceptive pill containing ulipristal acetate 30mg
16026843|NCT02689791|Dietary Supplement|Resistant Starch Type 4|single dose 26g fiber given at the breakfast meal
16026844|NCT02689778|Drug|Pirfenidone|Oral pirfenidone 600 mg with breakfast and 1200 mg pirfenidone with dinner for 12 months.
16026845|NCT02689778|Drug|Placebo|Identical tablets without active substance
16026846|NCT02689765|Dietary Supplement|Anthocyanins|Anthocyanins capsules, which comprises different natural Anthocyanins purified from bilberries and blackcurrants
16026847|NCT02689765|Dietary Supplement|Placebo|Placebo capsules is identically packaged.
16026848|NCT02689752|Drug|fruquintinib|fruquintinib suspension, 5mg ( 100mCi), oral, taken once, fast
16026849|NCT02689739|Procedure|venous duplex ultrasound|Venous duplex ultrasound
16026850|NCT02689726|Drug|GTL001+|
16026851|NCT02689726|Drug|Aldara|5% imiquimod cream
16026852|NCT02689713|Drug|Voriconazole (topical)|The voriconazole (Vfend®-IV 200mg) will be applied topically to one of two skin graft sites at a concentration of 150 micromolar. Dialysates will be collected over 12 hours post-skin graft/voriconazole application for analysis in the lab of OLAM concentrations.
16026853|NCT02689713|Drug|Topical Sterile Water Placebo Group|Sterile water will be applied topically to the other of the two skin graft sites. Dialysates will be collected over 12 hours post-skin graft/sterile water application for analysis in the lab of OLAM concentrations.
16026854|NCT02689700|Other|Blood samples|Taking blood form the umbilical cord (fetal circulation) and from the vein of the corresponding mother.
16026855|NCT02689687|Behavioral|Support partner|Participants will identify a support partner who will be contacted if the participant is non-adherent to their diuretic and/or weighing-in.
16026856|NCT02689687|Behavioral|Engagement incentives|Participants will be entered into a daily lottery, for which their participation is contingent on adhering to their diuretic and to weighing-in on the previous day.
16026857|NCT02689687|Behavioral|Electronic pill bottle|Participant adherence to their diuretic will be monitored on a daily basis and participants will be contacted if they are non-adherent to this medication.
16026858|NCT02689687|Behavioral|Bluetooth scale|Participant adherence to stepping on their scale will be monitored on a daily basis and participants will be contacted if they are non-adherent to weighing-in. Participant weight gain will also be monitored, and if weight gain exceeds a specific threshold, the managing physician will be notified through the electronic medical record system. Managing providers will also be sent a weekly report of weight measurements.
16026859|NCT02689635|Other|Sodium Restricted Diet|Cardiac Diet, as defined by our Hospital Nutritional Services (containing less than 2000 mg sodium per day)
16026860|NCT02689635|Other|Regular Diet|Non-Cardiac Diet, as defined by our Hospital Nutritional Services
16026861|NCT02689622|Other|research of disease-related factors|included in IPSS and IPSS-R, lactate dehydrogenase, ferritin level, transfusion- dependence, molecular markers as genes mutations
16026862|NCT02689622|Other|research of comorbidities|HCT-Comorbidity Index, MDS-Comorbidity Index, Adult Comorbidity Evaluation-27, Cumulative Illness Rating Scale-G
16026864|NCT02689609|Radiation|Intensity-modulated radiation therapy|All patients will receive intensity-modulated radiation therapy with or without chemotherapy as usual standard of care in our institution.
16026865|NCT02689596|Drug|Oxytocin|
16026866|NCT02689596|Other|Placebo|
16026867|NCT02689583|Biological|Antibiotic selection based on the antibiotic susceptibility testing|The biological intervention focused on the results from the antibiotic susceptibility testing. All patients should used the their susceptibility antibiotics according to antibiotic susceptibility testing of H. pylori. Considering the safety of drug usage, priority antibiotic selection was as follow: Amoxicillin > Clarithromycin > Levofloxacin >Tetracycline > Furazolidone > Metronidazole.
16026868|NCT02689583|Genetic|PPI selection based on the CYP2C19 gene polymorphism|PPI selection should based on the CYP2C19 gene polymorphism of patients. Patients have different metabolizers, such as poor metabolizers (PM), extensive metabolizers (EM) and intermediate metabolizer (IM). Different metabolism of patients should select different PPI or different doses of PPI. For IM and PM, in this study, patients selected the standard dose of Omeprazole. For EM, in this study, patients selected the Esomeprazole with increasing doses 50%-100%.
16026869|NCT02689583|Dietary Supplement|Probiotics usage based on the 16SrRNA sequencing|Different micro-environment in stomach may influence the antibiotic absorption. In this study, some patients could select probiotic as adjuvant therapy according to their micro-environment in stomach by 16SrRNA sequencing.
16026870|NCT02689570|Other|observational|no interventions; observational study
16026871|NCT02689557|Other|plethysmography|Validate the measurement made by electroactive polymer sensors (plethysmography) during walking tests in venous insufficient subjects and healthy subjects by comparing the measurement made by the reference technique by mercury gauge.
16026872|NCT02689544|Other|intervention with static stretching|Members of static stretching group performed three sets of 30 second self hamstring stretch (IT) of both lower limbs, with 30 seconds of rest between sets, totaling 3 minute intervention so.
16026873|NCT02689544|Other|intervention with Dynamic Stretching|Each subject contracting antagonist muscle (quadriceps) to the target muscle (hamstring), performing dynamic movements of hip flexion with the knee extended, repeated every 1 second. They amounted to 3 of 30 repetitions completing approximately three minutes of dynamic stretching for each lower.
16026874|NCT02689544|Other|Control|The control group volunteers no received intervention
16026875|NCT02689518|Drug|Intravitreal aflibercept injection|Intravitreal aflibercept injection 2 mg (0.05 mL) administered every 4 weeks for the first 3 months, followed by 2 mg (0.05 mL) intravitreal injection once every 8 weeks(2 months) with the option to treat monthly based on retreatment criteria for a total duration of 12 months.
16026876|NCT02689505|Drug|BI 836880|
16026877|NCT02689479|Procedure|Positron-Emission Tomography|Dynamic scanning is performed for 60 minutes. Image acquisition is performed in 3D and reconstructed using an iterative OSEM VUEPOINT algorithm
16026878|NCT02689479|Biological|11C-5-HTP|150-400 MBq [11C]5-HTP (approximately 2-5 MBq/kg) is administered manually as an intravenous bolus in a intravenous catheter in the arm prior to PET imaging.
16026879|NCT02689479|Procedure|Magnetic Resonance Imaging|Analysis will focus on adipose tissue distribution and composition in the liver.
16026880|NCT02689479|Procedure|Mixed-Meal Tolerance Test (MMTT)|
16026881|NCT02689479|Procedure|Continuous Glucose Monitoring System® (CGMS)|CGMS involves the subcutaneous (SC) placement of a glucose sensor connected by tubing to a pager-sized monitoring device that stores glucose data. Subjects will have the sensor placed in the clinic and wear it continuously for 72 - 84 hours (Gold) or 72-144 hours (iPro2).
16026882|NCT02689479|Procedure|Glomerular Filtration Rate Testing|
16026883|NCT02689479|Procedure|Blood draw|
16026884|NCT02689453|Biological|IL-15 plus alemtuzumab|rhIL-15 by s.c. injection Monday-Friday over two weeks; followed by alemtuzumab three times a week for a total of 4 weeks of alemtuzumab treatment.
16026885|NCT02689440|Drug|Dasatinib|Given PO
16026886|NCT02689440|Other|Laboratory Biomarker Analysis|Correlative studies
16026887|NCT02689440|Drug|Venetoclax|Given PO
16026888|NCT02689427|Procedure|Axillary Lymph Node Dissection|Undergo axillary lymph node dissection
16026889|NCT02689427|Drug|Enzalutamide|Given PO
16026890|NCT02689427|Other|Laboratory Biomarker Analysis|Correlative studies
16026891|NCT02689427|Procedure|Lymph Node Biopsy|Undergo lymph node biopsy
16026892|NCT02689427|Drug|Paclitaxel|Given IV
16026893|NCT02689427|Procedure|Therapeutic Conventional Surgery|Undergo surgical resection of primary tumor
16026894|NCT02689414|Procedure|Remote ischaemic preconditioning|Ischaemia is achieved by using a blood pressure cuff on an arm by raising the cuff pressure to 200 mm Hg or to a value that is 20 mm Hg greater than the patient's systolic blood pressure - if the patient's systolic blood pressure is more than 180 mm Hg. The intervention starts simultaneously with the induction of anaesthesia or a few minutes earlier.
16026895|NCT02689414|Procedure|Control to RIPC|Venous pressure is achieved by using a blood pressure cuff on an arm by raising the cuff pressure to 10-20 mm Hg. The intervention starts simultaneously with the induction of anaesthesia or a few minutes earlier.
16026896|NCT02689401|Drug|Ferumoxytol|
16026897|NCT02689401|Device|MRI 3T scanner|
16026898|NCT02689388|Procedure|Femoral Nerve Block|Use of femoral nerve block as part of general anesthesia
16026899|NCT02689375|Device|Senza Spinal Cord Stimulation system|Suitable participants will be booked to have spinal cord stimulator trial leads implanted and an external programmable High Frequency battery trial box as a day case
16026900|NCT02689362|Drug|Evogliptin|1 tablet per day
16026901|NCT02689362|Drug|Sitagliptin|1 tablet per day
16026902|NCT02689362|Drug|Placebo Evogliptin|1 tablet per day
16026903|NCT02689362|Drug|Placebo Sitagliptin|1 tablet per day
16026904|NCT02689349|Device|Implantation of Esteem|Subjects meeting indications are implanted with the Esteem Totally Implantable Hearing System
16026905|NCT02689336|Biological|Erlotinib|
16026906|NCT02689336|Drug|Temozolomide|
16026907|NCT02689323|Device|repeated transcranial magnetic stimulation|
16026908|NCT02689310|Other|Leptospermum scoparium honey|No information available- PI left- study being withdrawn.
16026909|NCT02689310|Other|Standard of Care Treatment|No information available- PI left- study being withdrawn.
16128599|NCT01945840|Other|Placebo infusion|
16026910|NCT02689297|Other|chlorine dioxide|First week, subjects were instructed to do regular tooth brushing. After that group A was requested to use chlorine dioxide mouthwash two time per days for three weeks in addition to tooth brushing and then, one week for combination of tooth brushing, tongue cleaning and mouth washing.
16026911|NCT02689297|Other|small toothbrush for tongue cleaning|First week, subjects were instructed to do regular tooth brushing. After that group B was requested to brush their tongue with small toothbrush two time per days for three weeks in addition to tooth brushing and then, one week for combination of tooth brushing, tongue cleaning and mouth washing.
16026912|NCT02689284|Biological|Margetuximab plus pembrolizumab|margetuximab in combination with pembrolizumab; combination treatment is administered once every 21-day cycle
16026913|NCT02689271|Other|MRI|VERDICT diffusion-weighted microstructure imaging sequence
16026914|NCT02689258|Drug|HTX-011B|
16026915|NCT02689258|Drug|Placebo|
16026916|NCT02689258|Drug|HTX-011A|
16026917|NCT02689258|Drug|HTX-002|
16026918|NCT02689258|Drug|Bupivicaine HCl|
16026919|NCT02689245|Drug|Tenofovir|
16026920|NCT02689245|Drug|Fecal Microbiota Transplantation (FMT)|
16026921|NCT02689232|Biological|Fresh Frozen Plasma|
16026922|NCT02689232|Biological|Platelets Concentrate|
16026923|NCT02689232|Biological|Cryo Precitipitate|
16026924|NCT02689219|Drug|Brentuximab Vedotin|Both cohorts will be treated similarly and in parallel but analyzed separately.
16026925|NCT02689206|Drug|GSK1278863|GSK1278863 will be supplied as a round, biconvex, 10 millimeter (mm) white film coated tablet with the unit dose strength of 5 mg and 25 mg.
16026926|NCT02689206|Drug|GSK1278863 matching Placebo|GSK1278863 matching placebo will be supplied as a round, biconvex, 10 mm white film coated tablet.
16026927|NCT02689193|Other|Blood sampling|Blood sampling (Volume depending on age, minimum 2.0 ml, maximum 10.9 ml extra)
16026928|NCT02689180|Drug|Placebo|Replacement of furosemide by placebo
16026929|NCT02689180|Drug|Furosemide|Maintenance of furosemide on usual doses
16026930|NCT02689167|Drug|Sunitinib|
16026931|NCT02689154|Device|W8Loss2Go|The participants will proceed through all parts of the app program (problem food withdrawal, snacking control and withdrawal from excessive portions) and receive weekly phone calls from the study coordinator, who will be monitoring app usage and providing motivation. Subjects will return to the EMPOWER clinic for a three month weight check and face-to-face meeting with their mentor. After the study period, participants will again complete the EBQ, and be offered continued enrollment in the EMPOWER clinic or continued home use of the mHealth technology.
16026932|NCT02689141|Drug|Bendamustine|Debulking: Cycles 1 - 2, d1 & 2: 70 mg/m2 i.v.
16026933|NCT02689141|Drug|Ofatumumab|"Induction:
~Cycle 1: Day 1 300 mg i.v.; Day 8 1000 mg i.v.; Day 15 1000 mg i.v. Cycle 2-6: Day 1 1000 mg i.v.
~Maintenance: After the induction ofatumumab iv 1000 mg every three months will be continued.
~Cycle 1-8: Day 1 1000 mg i.v."
16026934|NCT02689141|Drug|Ibrutinib|Induction: Cycle 2-6: d1-28: 420 mg p.o. Maintenance: After the induction ibrutinib p.o. 420 mg daily will be continued. Cycle 1-8: d1-84: 420 mg p.o.
16026935|NCT02689115|Other|Genetic relative expression|The genetic expression of NF-KB1 and IKK epsilon were quantified in both groups.
16026936|NCT02689102|Device|Probe based optical techniques|During the diagnostic bronchoscopy, optical biopsy of the mucosa and alveolar compartment will be conducted by two different probe based optical techniques (Confocal Laser Endomicroscopy (Mauna Kea technologies) and Optical Coherence Tomography (St Jude Medical)). After the study measurements a biopsy will be obtained in the same area.
16026937|NCT02689089|Drug|3HP|An interrupted time series study design will be used to determine if the introduction of the 3HP regimen will result in more people completing LTBI treatment compared to the standard of 9 months INH twice weekly.
16026938|NCT02689076|Other|HIE Notification|VA provider notification of non-VA hospitalization or ED visit via electronic health information exchange
16026939|NCT02689076|Other|Care transitions intervention|Post-hospital geriatrics care transitions coordinator provides home visit and telephone support for 30 days after hospital discharge
16026940|NCT02689063|Drug|Maxigesic IV|IV acetaminophen 1000 mg and IV ibuprofen 300 mg /100 mL solution for infusion, 100mL, every 6 hours for 48 hours
16026941|NCT02689063|Drug|IV Acetaminophen|IV Acetaminophen 1000 mg/100 mL solution for infusion, 100mL, every 6 hours for 48 hours
16026942|NCT02689063|Drug|IV Ibuprofen|IV Ibuprofen 300 mg/100 mL solution for infusion, 100mL, every 6 hours for 48 hours
16026943|NCT02689063|Drug|Placebo IV|Placebo IV- 100 mL intravenous saline for infusion, 100mL, every 6 hours for 48 hours
16026944|NCT02689050|Device|Needle based confocal laser endomicroscopy (nCLE)|During the fine needle aspiration of a suspected and a non-suspected lymph node we will obtain needle based CLE (nCLE) images within the lymph node. Fine needle aspirations will be obtained after the optical biopsy measurements. We will compare the results of the optical biopsy with the cytology results, or to histology in case an additional surgery is indicated.
16026945|NCT02689037|Procedure|Percutaneous transluminal angioplasty and stenting|Surgeons will plant stents after vascular angioplasty in target ICAS vessels within 5 days after randomization.
16026946|NCT02689037|Drug|Aspirin plus clopidogrel|aspirin 100mg daily and clopidogrel 75mg daily for 90 days
16026947|NCT02689024|Drug|Bupivacaine|Local anesthetic: amide group ATC code N01BB01
16026948|NCT02689024|Drug|Acetaminophen|Analgesic drug: Acetanilide derivate with analgetic and antipyretic properties ATC code N02BE01
16026949|NCT02689024|Drug|Diclofenac|Non-Steroidal Anti-Inflammatory Drug: Acetic acid derivative ATC code M01AB05 Usual dosage is 50 mg t.i.d. orally or 75 mg b.i.d. intramuscularly. In the Netherlands, intravenous administration is not used.
16026950|NCT02689024|Drug|Ibuprofen|Non-Steroidal Anti-Inflammatory Drug: Propionic acid derivative ATC code M01AE01 Usual dosage is 400 mg t.i.d. or q.i.d. orally.
16026951|NCT02689024|Drug|Naproxen|Non-Steroidal Anti-Inflammatory Drug: Propionic acid derivative ATC code M01AE02 Usual dosage is initially 500 mg orally, followed by 250 mg b.i.d. or t.i.d.
16026952|NCT02689024|Drug|Dipyrone|Analgesic drug: Pyrazolone derivate with analgetic, antipyretic and antiphlogistic properties ATC N02BB02 Usual dosage is 1000 mg t.i.d. or q.i.d. orally and intravenously
16027028|NCT02688452|Dietary Supplement|Control Unmodified Placebo Water|
16027029|NCT02688452|Dietary Supplement|Electrokinetically modified water (EMW)|
16026953|NCT02689024|Drug|Fentanyl|Opioids: Phenylpiperidine derivative. Short-acting opioid. ATC code N02AB03 Usual dosage is 1 ug/kg intravenously and titrated guided by pain scores and possible side effects. Above the age of 60, dosages are usually divided in two in order to prevent adverse events.
16026954|NCT02689024|Drug|Morphine|Opioids: Natural opium alkaloid. Longer-acting opioid. ATC code N02AA01 Usual dosage is 0.1 mg intravenously and titrated guided by pain and possible side effects. Above the age of 60, dosages are usually divided in two in order to prevent adverse events.
16026955|NCT02689024|Drug|Levobupivacaine|Local anesthetic: amide group ATC code N01BB10
16026956|NCT02689024|Drug|Ropivacaine|Local anesthetic: amide group ATC code N01BB09
16026957|NCT02689011|Procedure|Femoral Nerve Block|For patients in Femoral nerve Block Group (Group F), ultrasound guided Femoral nerve block was performed using 0.375% bupivacaine, 20 ml for femoral nerve
16026958|NCT02689011|Procedure|Epidural|Patients in Epidural Group (Group E) were turned in lateral position for epidural catheter placement in lumbar region. Epidural was loaded with 0.25% bupivacaine and infusion of M2 (Bupivacaine 0.1% + Fentanyl 2mcg/ml) was started at 8 - 12 ml per hour.
16026959|NCT02688998|Device|venous access PORT or PICC|Participants will receive a venous access prior to starting chemotherapy
16026960|NCT02688985|Drug|Ocrelizumab|Ocrelizumab will be administered as IV infusion.
16026961|NCT02688985|Procedure|Lumbar Puncture|Participants will receive LP as specified in individual arms. Lumbar puncture is optional at week 52, except for RMS Cohort Arm 3 and PPMS Cohort. In addition, the lumbar punctures in the Long Term Extension phase is every other year.
16026962|NCT02688985|Drug|Methyloprednisolone|Participants will receive 100 mg of IV methylprenisolone (or an equivalent) prior to ocrelizumab infusion.
16026963|NCT02688985|Drug|Antihistamine|Participants will receive an antihistamine, such as diphenhydramine, prior to ocrelizumab infusion.
16026964|NCT02688972|Other|cold water immersion|The volunteers stayed immerged up to the iliac crest, in the water with water. The temperature utilized was 10 degree C and the time was 10 minutes
16026965|NCT02688972|Other|Control group|The volunteers stayed in rest about 10 minutes
16026966|NCT02688959|Behavioral|Tai Chi|
16026967|NCT02688959|Behavioral|Exercise|
16026968|NCT02688946|Other|Not provided|
16026969|NCT02688933|Drug|HOE901-U300 (Insulin Glargine 300 U/ml)|Self-administered by subcutaneous (SC) injection in the morning (between waking up and breakfast) using a pre-filled pen.
16026970|NCT02688933|Drug|Lantus (Insulin Glargine 100 U/ml)|Self-administered by subcutaneous (SC) injection in the morning (between waking up and breakfast using a pre-filled pen.
16026971|NCT02688933|Drug|Mandated back ground therapy|Rapid insulin analogs: e.g., insulin glulisine, insulin lispro or insulin aspart, used by participant at least 30 days before screening. Mealtime insulin was to be continued during the study and titrated towards protocol specified postprandial glucose targets (130-180 mg/dL).
16026972|NCT02688920|Procedure|EUS and OCT imaging|Intraluminal imaging using endoscopic ultrasound and endoscopic optical coherence tomography
16026973|NCT02688907|Drug|AZD1775|Dosage and Schedule : AZD1775 175 mg BID per os every 12 hours (x 6 doses, 3 days) administered days 1-3 the first & second weeks every 21 days Patients will continue to receive study treatment as described above, until they demonstrate objective disease progression (determined by RECIST 1.1) or they meet any other discontinuation criteria.
16026974|NCT02688894|Other|No treatment is included in this protocol.|"Tumor tissues (fresh or archival) will be analyzed using NGS-based cancer panel, nanostring CNV, immunohistochemistry and/or FISH.
~Specific methods of each molecular tests will be defined with standard laboratory manual developed by pathologists."
16026975|NCT02688881|Drug|sirolimus|Rapamune
16026976|NCT02688868|Device|FirehawkTM 2.25mm|Implantation of the released specification (2.25mm) of FirehawkTM rapamycin target-eluting coronary stent systems
16026977|NCT02688855|Device|Active Combined Magnetic Field OL1000 Bone Growth Stimulator|Active CMF OL1000 Device
16026978|NCT02688855|Device|Sham Combined Magnetic Field OL1000 Bone Growth Stimulator|Sham CMF OL1000
16026979|NCT02688842|Device|Rapamycin target-eluting coronary stent systems (38mm)|
16026980|NCT02688829|Device|Rapamycin target-eluting Coronary Stent System|Implantation of the rapamycin-eluting coronary stent system
16026981|NCT02688816|Device|Xpert HPV|Point-of-care HPV DNA PCR test
16026982|NCT02688816|Device|OncoE6|Point-of-care E6 oncoprotein test
16026983|NCT02688803|Drug|Dose dense AC-P|(doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 175 mg/m2 q2weeks x 4 cycles)
16026984|NCT02688803|Drug|Dose dense AC|Dose dense AC followed by weekly P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 80 mg/m2 weekly x 12 cycles)
16026985|NCT02688803|Drug|FEC-D|FEC-D (5-FU 500 mg/m2 plus epirubicin 100 mg/m2 plus cyclophosphamide 500 mg/m2 q3weeks x 3 cycles followed by docetaxel 100 mg/m2 q3weeks x 3 cycles)
16026986|NCT02688790|Drug|Dalbavancin|
16027030|NCT02688452|Dietary Supplement|Electrokinetically modified water (EMW)|
16027031|NCT02688452|Dietary Supplement|Control Unmodified Placebo Water|
16027032|NCT02688439|Other|Sciatic Nerve block|
16027033|NCT02688439|Other|Leg raised 30°|
16027034|NCT02688439|Other|Distal tourniquet placed on the lower part of the leg|
16027035|NCT02688439|Other|Leg in a neutral position|
16027036|NCT02688426|Device|Sham Low-Level Laser Therapy (Sham LLLT)|perform with the machine off
16028476|NCT02677571|Procedure|Paravertebral Thoracic block|
16026988|NCT02688764|Drug|PA21 (Velphoro®)|"During Stage 1 (Open-Label Dose Titration; up to 10 weeks), PA21 subjects will receive PA21 at a starting dose based on their age. Dose of PA21 will be increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject has been receiving that dose for a minimum of 2 weeks, and for safety or tolerability reasons at any time.
~During Stage 2 (Open-Label Safety Extension, 24 week safety extension),subjects will continue on the dose received at the end of Stage 1, unless a dose change is required. Doses may be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject has been receiving that dose for a minimum of 2 weeks, and for safety or tolerability reasons at any time during Stage 2."
16026989|NCT02688764|Drug|Calcium Acetate (Phoslyra®)|"During Stage 1 (Open-Label Dose Titration; up to 10 weeks), Phoslyra subjects will receive Phoslyra either at a starting dose based on their weight or, if considered more appropriate by the Investigator, at an equivalent dose of their previous phosphate binder (PB), calcium-based or sevelamer. Dose of Phoslyra will be increased or decreased as required for efficacy (to achieve age specific target serum phosphorus level), provided a subject has been receiving that dose for a minimum of 2 weeks, and for safety or tolerability reasons at any time.
~During Stage 2 (Open-Label Safety Extension, 24 week safety extension),subjects will continue on the dose received at the end of Stage 1, unless a dose change is required. Doses may be titrated for efficacy (to achieve age specific target Serum phosphorus levels), provided a subject has been receiving that dose for a minimum of 2 weeks, and for safety or tolerability reasons at any time during Stage 2."
16026990|NCT02688751|Radiation|time-resolved CT Angiography|A multi-phase contrast CT
16026991|NCT02688751|Procedure|Contrast Enhanced Ultrasound|A ultrasound scan with micro bubble contrast injection
16026992|NCT02688738|Drug|Doxycycline|
16026993|NCT02688725|Device|post mastectomy ultrasound|post mastectomy ultrasound
16026994|NCT02688712|Drug|LY2157299|Small molecule inhibitor of transforming growth factor-beta signaling pathway
16026995|NCT02688712|Drug|Capecitabine|Antimetabolite chemotherapy
16026996|NCT02688712|Drug|Fluorouracil|Antimetabolite chemotherapy
16026997|NCT02688712|Procedure|Tumor specific mesorectal excision|Tumor specific mesorectal excision
16026998|NCT02688699|Procedure|EndoClot|"All patients enrolled and submitted to EMR or ESD in several units of Italian endoscopy will be divided into two different groups: in a first group will be included patients at the endoscopic end of which will be applied EndoClotTM based on the lesion removed in addition to the treatment Standard (drug injection, electrocoagulation, metal clips). The second group, on the other hand, includes patients in whom EndoClotTM will not be used.
~Before the end of the procedure neither the endoscopist nor the patient will know the group because the group to which the patient is assigned will be written in a sealed envelope that will be opened only at the end of the procedure before the endoscope extraction: The use of EndoClotTM will depend on the group to which the patient belongs."
16026999|NCT02688686|Biological|genetically modified dendritic cells + cytokine-induced killer|This Phase I/II Study to evaluate clinical efficacy, safety of genetically modified dendritic cells in combination with cytokine-induced killer cell treament in NSCLC with bone metastases.
16027000|NCT02688673|Biological|adenovirus-transfected autologous DC vaccine plus CIK cells|
16027001|NCT02688660|Other|MRI Scans|
16027002|NCT02688647|Drug|KD025|
16027003|NCT02688647|Other|BSC|Treatment/drug as determined by each subject's prescribing physician
16027004|NCT02688634|Drug|Amoxicillin|Amoxicillin will be given as: 7 days, 20mg/kg orally every 6 hours to a maximum of 1.8g/day for a 7-day period.
16027007|NCT02688608|Drug|Pembrolizumab|200 mg IV once every 3 weeks
16027008|NCT02688595|Device|Ultrasound|Ultrasound-guided central venous catheterization in internal jugular vein
16027009|NCT02688595|Other|General anesthesia|Scheduled operation under general anesthesia
16027010|NCT02688582|Other|TCI group|Drug: cefepime, Device: Target Controlled Infusion pump connected to Rugloop vII software
16027011|NCT02688569|Behavioral|Cognitive Behavioral Therapy for Chronic Widespread Pain|CBT-CWP in this study involves 4 sessions of one-hour non-drug behavioral intervention. Session 1 involves education about pain and insomnia and the relationship between the two. Participants will also learn sleep hygiene and stimulus control skills. Session 3 involves teaching participants skills to limit non-sleep time in bed and thus increase sleep efficiency. Participants will also learn the relationship between pain and activity. Session 4 involves teaching participants cognitive restructuring and mindfulness skills to manage maladaptive thoughts related to pain and insomnia. Participants will also review the skills they learned and discuss the maintenance of treatment gains.
16027012|NCT02688556|Drug|cyclosporine|
16027013|NCT02688556|Drug|vehicle of OTX-101|
16027014|NCT02688543|Procedure|RF treatment|the genicular nerves are identified with the help of landmarks, ultrasound and nerve stimulation. Once the needle is correctly placed high frequency current is passed through the probe during 90 seconds at 20 V with tip temperature put to 80°C.
16027015|NCT02688543|Radiation|radiofrequency ablation|
16027016|NCT02688543|Device|ultrasound|
16027017|NCT02688530|Drug|IV Saline|
16027018|NCT02688530|Drug|IV Dexamethasone 4mg|
16027019|NCT02688530|Drug|IV Dexamethasone 6mg|
16027020|NCT02688530|Drug|IV Dexamethasone 8mg|
16027021|NCT02688517|Other|Cytology Specimen Collection Procedure|Undergo collection of blood samples
16027022|NCT02688517|Other|Laboratory Biomarker Analysis|Correlative studies
16027023|NCT02688491|Drug|sunitinib|The investigators randomly assign assay-defined high risk patients of stageIII ccRCC into intervention group and observation group. The intervention group should receive adjuvant targeted therapy while the control group deserve observation.
16027024|NCT02688478|Other|Phthalate|Delivered by inhalation on day 1 of the triad
16027025|NCT02688478|Other|Filtered Air|Delivered by inhalation on day 1 of the triad
16027026|NCT02688478|Other|Allergen|Subject specific allergen is delivered by inhalation on day 1 of the triad
16027027|NCT02688465|Drug|Apomorphine|
16027038|NCT02688413|Device|MindMotionPRO|The MindMotionPRO, a certified device for medical use, is a virtual reality based system to train upper limb activities in a game scenario. The participant will receive 5 exercises sessions with the MindMotionPRO per week over 4 weeks. This is done in addition to standard practice for upper limb rehabilitation which should be at least 30 min five times per week.
16027039|NCT02688413|Other|Self-Directed Prescribed Exercises|GRASP is an arm and hand exercise program for stroke patients, designed to supplement standard rehabilitation therapies. The participant will receive 5 GRASP exercises sessions per week over 4 weeks. This is done in addition to standard practice for upper limb rehabilitation which should be at least 30 min five times per week.
16027040|NCT02688400|Drug|Diacerein|
16027041|NCT02688400|Drug|Celecoxib|
16027042|NCT02688400|Drug|Placebo|
16027043|NCT02688387|Drug|FDC (ambrisentan 10 mg-tadalafil 40 mg) single dose|The four FDCs in part 1 will have the following formulation designation: FDC1, FDC2, FDC3 and FDC4. They are film-coated tablets. The dose will be administered orally. Study treatment for Part2 and Part 3 will be amended after Part 1 study
16027044|NCT02688387|Drug|Reference (ambrisentan 10 mg + tadalafil 40 mg given concurrently)|Ambrisentan is a film-coated tablet. Each tablet of ambrisentan contains 10 mg of ambrisentan, approximately 95 mg of lactose (as monohydrate), 0.25 mg of lecithin and 0.11 mg of Allura red AC Aluminium Lake. Tadalafil is also a film-coated tablet. Each tablet of Tadalafil contains 20 mg tadalafil and 233 mg lactose. Both the tablets will be administered orally concurrently.
16027045|NCT02688374|Other|Treatment A: Nicorette 2 mg coated mint gum|Participants will be administered with 2 mg coated mint gum of Nicorette
16027046|NCT02688374|Other|Treatment B: Nicotinell 2 mg coated mint gum|Participants will be administered with 2 mg coated mint gum of Nicotinell
16027047|NCT02688374|Other|Treatment C: Nicotinell 2 mg coated fruit flavor gum|Participants will be administered with 2 mg coated fruit flavor gum of Nicotinell
16027048|NCT02688361|Drug|Fluimucil® 2% solution|Participants will be orally administered with 10ml of 2% oral solution of Fluimucil® (reference).
16027049|NCT02688361|Drug|Acetylcysteine 2% solution|Participants will be orally administered with 10ml of 2% oral solution of Acetylcysteine (test)
16027050|NCT02688348|Other|Quality-of-Life Assessment|Ancillary studies
16027051|NCT02688348|Other|Questionnaire Administration|Ancillary studies
16027052|NCT02688335|Device|Cloud9|Low-pressure Continuous Positive Airway Pressure (CPAP = 2 - 4 cm H2O).
16027053|NCT02688322|Drug|Sulbactam|2 g in 100 ml of normal saline solution and administered via an infusion pump at a constant flow rate 1 h every 12 h. Blood samples (approximately 5 ml) will be obtained by direct venepuncture at the following time: 0, 0.5, 1, 1.5, 2, 3, 4, 5, 6, 8 and 12 h after 7th dose of sulbactam
16027054|NCT02688309|Drug|Ozurdex|Patients from the clinic will be considered for enrollment if they are receiving an intraocular injection of a steroid as part of standard care for macular edema or progressive fibrosis. Clinic patients who are receiving an intraocular injection of steroid (Ozurdex) as part of standard care who agree to participate will have an AC tap just prior to the intraocular injection of steroid and a second AC tap at a follow up visit 6 ± 2 weeks after the steroid injection.
16027055|NCT02688309|Procedure|Surgery|The 60 patients from the operating room will be patients undergoing surgery for one of the following conditions: (1) Proliferative Diabetic Retinopathy, (2) rhegmatogenous retinal detachment with PVR, (3) rhegmatogenous retinal detachment without PVR, (4) macular pucker, (5) macula hole. All patients will be administered an AC (Anterior Chamber) tap just prior to the surgical procedure while in the OR.
16027056|NCT02688309|Procedure|Anterior Chamber (AC) Tap|A paracentesis removing about 0.1 ml of fluid from the front part of the eye (the aqueous chamber) will be performed in the operating room just prior to surgery or in the clinic. In the operating room, the AC tap is done after the eye is anesthetized and cleaned with 5% povidone iodine for the surgery. A 30-gauge needle attached to a tuberculin syringe is inserted into the AC and 0.1 ml of aqueous is removed. The wound is self-sealing and has no effect on the surgery. In the clinic, the AC tap is done after drops of proparacaine and 5% povidone iodine is placed in the eye and a lid speculum is inserted. The patient is seated at a slit lamp and a 30-gauge needle attached to a tuberculin syringe is inserted into the AC and 0.1 ml of aqueous is aspirated and then the needle is removed.
16027057|NCT02688296|Device|Fibulock|Fibulock intramedullary implant will be used to repair fibula fractures
16027058|NCT02688283|Other|Nutrient cluster|Test cluster is an optimized savory cluster made through a proprietary baking process combined with slow digestible carbohydrates and fiber
16027059|NCT02688270|Drug|Vascana (0.9% nitroglycerin cream)|Study drug administered topically
16027060|NCT02688270|Drug|Vehicle (placebo)|Vehicle administered topically
16027061|NCT02688257|Other|MRI|Functional magnetic resonance imaging
16027062|NCT02688257|Other|Ultrasound|Optoacoustic imaging
16027063|NCT02688244|Procedure|Irrigation|Irrigation of the abdominal cavity with at least 300ml of normal saline using the power suction/irrigator
16027064|NCT02688244|Procedure|No irrigation|Suction only, using suction device
16027065|NCT02688231|Other|Task-oriented upper limb training|"Participants in the experimental groups (high-intensity and low-intensity) receive for 8 weeks, 60 min/day, 5 days/week a task-oriented upper limb rehabilitation training at a high or low intensity, respectively, instead of their regular occupational therapy hours provided in the conventional multidisciplinary rehabilitation program.
~The task-oriented training involves practicing of functional daily tasks, with the intention to acquire or reacquire a skill. Most functional upper limb tasks require following essential movement components: reaching, moving, positioning, transporting, lifting the upper limb and/or an object and grasping, releasing, stabilizing, manipulating an object.
~The Tagtrainer of SymbioTherapy is used to support the independent training of tasks with real objects with different sizes and weights. The Diego of Tyromotion is used in patients who require assistance (gravity support) during the performance of different upper limb tasks."
16027066|NCT02688231|Other|Control intervention|"The participants in the control group receive for 8 weeks the conventional multidisciplinary rehabilitation program (physiotherapy, occupational therapy and speech or cognitive therapy if needed).
~The training sessions are scheduled for 60 min/day, 5 days/week for the duration of 8 weeks."
16027067|NCT02688218|Behavioral|Aerobic Exercise|Exercise for three 15 minute periods, with 10 minute rests between each period, and exercise intensity will vary between periods to achieve different energy expenditures, which may be determined based on VO2 measurements.
16027068|NCT02688218|Behavioral|Resistance Exercise|Subjects will perform 5-15 minutes of up to 7 different activities of daily living, followed by 20 minutes of resistance exercise, such as straight leg raises.
16027069|NCT02688205|Other|Cyriax's functional examination|included active range of motion, passive range of motion, resisted test and accessory test for shoulder pain evaluation
16027070|NCT02688205|Device|Ultrasound examination|to evaluate rotator cuff, acromio-clavicular joint, and subdeltoid-subacromial bursa
16027071|NCT02688192|Behavioral|Exercise Intervention|Participate in fitness program
16027072|NCT02688192|Behavioral|Internet-Based Intervention|Engage in private social support messaging and Use the mobile app
16027073|NCT02688192|Device|Monitoring Device|Wear an electronic accelerometer
16027074|NCT02688192|Other|Quality-of-Life Assessment|Ancillary studies
16027075|NCT02688166|Other|Complete Cardiac Magnetic Resonance Imaging (MRI)|Complete Cardiac Magnetic Resonance Imaging (MRI) prior to treatment and then at approximately 1 year after completion of radiation therapy
16027076|NCT02688153|Device|EDWARDS INTUITY|To evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing AVR & CABG.
16027077|NCT02688153|Device|Stented aortic bioprostheses|In comparison to control valves available on the market.
16027078|NCT02688140|Drug|Arsenic trioxide|
16027079|NCT02688140|Drug|Idarubicin|
16027080|NCT02688140|Drug|Cytarabine|
16027081|NCT02688140|Drug|Tretinoin|
16027082|NCT02688140|Drug|Mitoxantrone|
16027083|NCT02688140|Drug|Mercaptopurine|
16027084|NCT02688140|Drug|Methotrexate|
16027085|NCT02688127|Drug|Tranexamic Acid|tranexamic acid or placebo are given before cesarean section in patient with placenta previa
16027086|NCT02688114|Procedure|Baseline surveillance endoscopy|All study participants will undergo endoscopy with NinePoint NvisionVLE volumetric laser endomicroscopy and biopsy of the esophageal mucosa and gastric cardia.
16027087|NCT02688114|Procedure|Radiofrequency ablation|All study participants will undergo radiofrequency ablation of Barrett's esophagus
16027088|NCT02688114|Procedure|Follow up endoscopy 1|All study participants will undergo follow up endoscopy 1 week after RFA, which includes endoscopy, NinePoint NvisionVLE volumetric laser endomicroscopy, and biopsies.
16027089|NCT02688114|Procedure|Follow up endoscopy 2|All study participants will undergo follow up endoscopy 2 weeks after RFA, which includes endoscopy, NinePoint NvisionVLE volumetric laser endomicroscopy, and biopsies.
16027090|NCT02688114|Procedure|Follow up endoscopy 3|All study participants will undergo follow up endoscopy 4 weeks after RFA, which includes endoscopy, NinePoint NvisionVLE volumetric laser endomicroscopy, and biopsies.
16027091|NCT02688101|Drug|DpC|iron chelator
16027092|NCT02688088|Drug|Drug Cocktail|Administered orally
16027093|NCT02688088|Drug|Abemaciclib|Administered orally
16027094|NCT02688075|Other|No Intervention|Participants who are receiving Canagliflozin +/- other AHA as per usual clinical practice will be observed for effectiveness, safety and PRO.
16027095|NCT02688062|Biological|NeuroRegen Scaffold with BMMCs transplantation|Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with bone marrow mononuclear cells (BMMCs) transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.
16027096|NCT02688062|Procedure|Surgical intradural decompression and adhesiolysis|Patients with chronic SCI (ASIA grade A) will receive intradural decompression and adhesiolysis surgery and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.
16027097|NCT02688049|Biological|NeuroRegen scaffold/mesenchymal stem cells transplantation|Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with 10 million mesenchymal stem cells transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.
16027098|NCT02688049|Biological|NeuroRegen scaffold/neural stem cells transplantation|Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with 10 million neural stem cells transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.
16027099|NCT02688036|Radiation|hypofractionated concurrent chemoradiotherapy|For patients with Limited Disease Small Cell Lung Cancer, 45Gy/15F of radiotherapy with concurrent chemotherapy will be used in experimental arm.
16027100|NCT02688036|Radiation|conventionally fractionated concurrent chemoradiotherapy|For patients with Limited Disease Small Cell Lung Cancer, 60Gy/30F of radiotherapy with concurrent chemotherapy will be used in the control arm.
16027101|NCT02688023|Drug|oxaliplatin;irinotecan;leucovorin;5-fluorouracil;capecitabine;S-1|The regimen consisted of irinotecan 150mg/m2 administered as an intravenous infusion on day 1, oxaliplatin 85 mg/m2 administered intravenously on day 2, leucovorin 200 mg intravenously on day 2, 5-fluorouracil 500 mg administered by intravenous bolus,followed by 2400 mg/m2 by 44 h continuous intravenous infusion starting on day 2. S-1 (40-60mg orally twice per day for 10 days) or capecitabine (1000mg/m2 orally twice per day for 10 days) can be substituted for intravenous 5-fluorouracil.14 days as a cycle, up to 4 cycles.
16027102|NCT02688010|Behavioral|Noise reduction and cycled light|Reduced noise exposure (sound levels <45 dB) and cycled light (approximately 12 hours of light on and 12 hours of light off).
16027103|NCT02687997|Other|poligraphy|Sleep study
16027104|NCT02687984|Drug|RBP-7000|A single subcutaneous injection with doses of RBP-7000 containing 120 mg risperidone and either a low, high, or intermediate molecular weight PLGH polymer.
16027105|NCT02687971|Drug|Miltefosine|Miltefosine (hexadecylphosphocholine) is an oral drug which has proven to be effective for the treatment of Visceral leishmaniasis (VL) in the Indian sub-continent. It has also been tested for CL, yielding varying results. Miltefosine was approved by FDA in 2014 for the treatment of CL in the New World for lesions due to L. braziliensis, L. panamensis and L. guyanensis only.
16027106|NCT02687958|Drug|Everolimus|Maintenance therapy
16027107|NCT02687945|Procedure|Outpatient physiotherapy|
16027108|NCT02687945|Procedure|Self-guided physiotherapy|
16027109|NCT02687932|Drug|LCZ696|
16027110|NCT02687932|Drug|Valsartan|
16027172|NCT02687412|Procedure|fast solid|fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia;
16027111|NCT02687919|Other|Modified Paleo diet|Nine cups of vegetables and some fruits, meat protein including organ meat, and complete abstinence from products containing gluten (wheat, barley, rye, etc.), dairy, potatoes, and legumes (beans, lentils, peanuts, soy, etc.)
16027112|NCT02687906|Drug|Vabomere|Vabomere (meropenem-vaborbactam) for IV injection
16027113|NCT02687893|Behavioral|Aerobic Exercise|Subjects will exercise on a treadmill for 45 minutes twice during the intervention week. Subjects will exercise at a fixed intensity level to a target heart rate (±10%) based on the heart rate achieved at 60% of their VO2max determined at screening. The speed and grade of the treadmill will be adjusted by trained research personnel with a goal of keeping participants within their target heart rate range for the entire 45 minutes.
16027114|NCT02687893|Behavioral|Resistance Exercise|Subjects will participate in resistance exercises for 45 minutes twice during the intervention week. Subjects will perform multiple-joint exercises with slow to moderate lifting velocity, for 1-3 sets per exercise at a weight that can be lifted for 8-12 repetitions (~60-80% of 1-repetition max). The exercises may include leg press, bench press, leg extension, leg flexion and seated row. Subjects will perform the exercises through the full range of motion. Between each set of repetitions, there would be a 2 minute rest period. The duration of the exercise testing would be approximately 45 minutes.
16027115|NCT02687880|Procedure|Testicular biopsy|Subjects will undergo a surgical procedure to harvest their testicular tissue.
16027116|NCT02687867|Drug|Dabigatran (Pradaxa)|As prescribed by treating physicians
16027117|NCT02687867|Drug|Vitamin K antagonist|As prescribed by treating physicians
16027118|NCT02687854|Drug|Apixaban|As prescribed by treating physicians
16027119|NCT02687854|Drug|Vitamin K antagonist|As prescribed by treating physicians
16027120|NCT02687841|Drug|AST-120and pentoxyphylline (PTX)|AST-120 2g 4 times a day for 5 days then AST-120 2g 3 times a day for 5 days pentoxyphylline 400mg QD PO x 10 days.
16027121|NCT02687841|Drug|pentoxyphylline (PTX)|pentoxyphylline 400mg QD PO x 10 days.
16027122|NCT02687815|Drug|vitamin D3 4000 IU|The vitamin D3 will be in oral gel cap form and contain 4000 International Units (IU) of cholecalciferol per gel cap.
16027123|NCT02687815|Drug|Placebo|The placebo is a gel cap that is indistinguishable from the vitamin D3 gel cap.
16027124|NCT02687802|Other|mechanical ventilation|we will measure static resistance, compliance and intrinsic positive end-expiratory pressure (PEEP) and other variables as risk factors for asynchrony occurrence
16027125|NCT02687789|Other|Medical Device: WO3191|application of vaginal suppository WO3191: 2 days per week (with a treatment-free interval of three days or two days, respectively; e.g. Monday and Friday)
16027126|NCT02687789|Other|Medical Device: Vagisan® Lactic Acid|application of Vagisan® Lactic Acid: 2 days per week (with a treatment-free interval of three days or two days, respectively; e.g. Monday and Friday)
16027127|NCT02687763|Biological|ProQuad|"2) Patients 6 months to 24 months of age who are being considered and/or evaluated for any solid organ transplant within the next five (5) years who are willing:
~to receive two doses of ProQuad® at least 30 days but no more than 365 days apart.
~to participate in the three (3) antibody titer blood draws."
16027128|NCT02687750|Device|MRI|Investigational device is a dual tuned (fluorine/proton) MRI surface coil designed and produced by Clinical MR solutions
16027129|NCT02687737|Procedure|Electromyography|During the fine wire electromyography (EMG), the participant will be asked to complete breathing exercises at 50% and 75% of their maximum capacity (determined prior to fine wire EMG using manometry) to determine activation and recruitment of genioglossus muscle.
16027130|NCT02687737|Procedure|Maximum expiratory pressure|The participants' maximum expiratory pressure (MEP) will be assessed using a hand-held digital manometer (MP01, Micro Direct Inc.). The subject will be standing and while wearing a nose clip be asked to blow out as hard and fast as they can to determine their MEP. This will be completed a maximum of three times to obtain values within close range of one another.
16027131|NCT02687737|Procedure|Videofluoroscopy|Videofluoroscopy allows for time-synced, frame-by-frame data analysis for the specific measures taken during swallowing tasks.
16027132|NCT02687737|Behavioral|Swallowing Tasks|"These include: an anterior tongue press to the alveolar ridge (behind the front molars), a saliva swallow, a 10 mL barium swallow, a 10 mL barium hard swallow (i.e. swallowing with extra effort), and two breathing exercise trials at 50% MEP and 75% MEP."
16027133|NCT02687724|Drug|Golimumab (GLM)|GLM is a human IgG1κ monoclonal antibody produced by a murine hybridoma cell line with recombinant DNA technology
16027134|NCT02687698|Other|Ketogenic diet|The proposed ketogenic diet will concern a low glucidic diet with 60-70% of lipidic intake and 20-30% of proteins.
16027135|NCT02687685|Other|Skin to skin contact immediate|Immediate SSC (intervention group) At birth, the baby will be dried and placed at the mother's breast where thermoregulation maneuvers will be applied and, once cord clamping has taken place, the baby will be left in SSC with the mother where the immediate neonatal adaptation interventions will take place. Mother and baby will be left in SSC for at least 1 h or until the baby has completed its first lactation properly. Once completed, the baby will be taken to the heat lamp to perform and complete all the newborn mediate adaptation interventions. If the mother expresses the desire to continue in SSC, this will be allowed again after these interventions. During immediate SSC, mother and baby will receive continuous monitoring by the health staff.
16027136|NCT02687685|Other|skin to skin contact early|Early SSC group (control group) At birth, the baby will be dried and placed on the abdomen and chest of their mother where thermoregulation maneuvers are applied once cord clamping has been completed. At this time, the baby will placed under the radiant heat lamp in order to complete all newborn adaptation interventions. Once stable, the mother and the baby will proceed with the initiation of SSC for at least 1 h or until the baby has completed the first lactation adequately; SSC will be allowed to continue if the mother expresses a desire to do so. During SSC, the mother and baby will receive monitoring by health personnel. All adaptation interventions, mediate and immediate, in the newborn will take place under the radiant heat lamp during the first postnatal hour.
16027137|NCT02687672|Biological|Stem Cell Transplantation|Transplantation of autologous stem cells
16027138|NCT02687659|Device|TEMIS system|Wearing TEMIS system over the day during one week
16027170|NCT02687412|Procedure|bowel preparation|patients are not received mechanical bowel preparation, only oral intestinal cleaner 12 h pre-operation can be accepted, but no need of liquid stool
16027171|NCT02687412|Procedure|preoperative treatment with carbohydrates|preoperative treatment with carbohydrates (patients without diabetes).
16027139|NCT02687646|Drug|Adult Allogeneic Mesenchymal cells from adipose tissue.|"Study treatment consists of Mesenchymal Stem Cell (MSC) derived from donors adipose tissue and expanded in vitro in a specific medium with platelet lysate without addition of animal derived products.
~Subjects will receive four sequential IV dose of Mesenchymal stem cells.
~Sequential doses:
~Day 1: 0.7-1 x 106 MSC / kg Day 4: 0.7-1 x 106 MSC / kg Day 11: 0.7-1 x 106 MSC / kg Day 18: 0.7-1 x 106 MSC / kg"
16027140|NCT02687633|Behavioral|JASPER|JASPER (Joint Attention, Symbolic Play, Engagement, and Regulation) is a treatment approach based on a combination of developmental and behavioral principles developed by Dr. Connie Kasari and Dr. Amanda Gulsrud at UCLA. It targets the foundations of social communication (joint attention, imitation, play) and uses naturalistic strategies to increase the rate and complexity of social communication.
16027141|NCT02687607|Device|WEB Aneurysm Embolization System|
16027142|NCT02687594|Drug|sucroferric oxyhydroxide|The non-interventional design allows the observation of patients in a broad range of settings reflecting routine clinical practice. All decisions on therapeutic or diagnostic procedures, treatments, management of the disease, or resource utilisation will be at the full discretion of the treating physician without interference by a sponsor or study protocol. All treatment decisions will follow the real-life treatment behaviour.
16027143|NCT02687581|Device|IO-therapy Glasses|12-hour of 50% intermittent occlusion therapy on the fellow eye.
16027144|NCT02687581|Device|patch|6-hour of eye patch on the fellow eye
16027145|NCT02687568|Other|EEG monitoring|Value of EEG monitoring as adjunct to standard monitoring
16027146|NCT02687555|Behavioral|Cognitive Bias Modification of Appraisals (CBM-App)|
16027147|NCT02687555|Behavioral|Peripheral Vision Task (control condition)|
16027148|NCT02687542|Drug|Placebo|Placebo
16027149|NCT02687542|Drug|PF-06649751 low dose (1 mg QD)|PF-06649751 low dose (1 mg QD)
16027150|NCT02687542|Drug|PF-06649751 middle dose 1 (3 mg QD)|PF-06649751 lower middle dose 1 (3 mg QD)
16027151|NCT02687542|Drug|PF-06649751 middle dose 2 (7 mg QD)|PF-06649751higher middle dose 2 (7 mg QD)
16027152|NCT02687542|Drug|PF-06649751 high dose (15 mg QD)|PF-06649751 high dose (15 mg QD)
16027153|NCT02687529|Device|CST001|
16027154|NCT02687516|Behavioral|Family-based behavioral social facilitation therapy|"Family-based Behavioral Social Facilitation Treatment (FBSFT) is founded on the principles of standard family-based behavioural therapy for obesity. FBSFT targets life-style behaviors (diet, physical activity and sedentary activity) in a family setting. FBSFT includes some cognitive elements that are considered important in relation to behavioural change for instance problem solving and cognitive restructuring. FBSFT has an intensive treatment phase including weekly family meetings with therapists over 17 consecutive weeks. Further monthly or bi-weekly follow-up sessions with a focus on social facilitation and maintenance of healthy habits are recommended. The dietary guidance of FBSFT is based on the Traffic light diet in which foods are organized into GREEN, YELLOW and RED groups. Activity guidance of FBSFT uses the same system: GREEN activities have the highest intensity and should be engaged in most often, YELLOW activities sometimes, and RED activities."
16027155|NCT02687516|Behavioral|TAU - Treatment as usual|"This is the default treatment at the obesity clinic. After initial evaluation by paediatrician, nurse, nutritionist and physiotherapist, a contract is written including weight goal, nutritional plan and activity plan. Follow up monthly in primary Health care and every 3rd month at the obesity clinic."
16027156|NCT02687503|Dietary Supplement|Probiotic|All children will receive a daily dose of probiotic (10⁹ cfu of L.acidophilus NCFM and B. lactis, Bi-07), a commercially available probiotic. Parents will give probiotic in 1 ounce of milk or water once a day for 30 days in an open label fashion.
16027157|NCT02687490|Drug|Abraxane|125 mg/m2, D1, D8, D15
16027158|NCT02687477|Procedure|Pulmonary Arterial Denervation|Contrast pulmonary artery （PA) angiography was performed to localize the pulmonary artery bifurcation level and calculate the PA diameter.Once the anatomy was deemed acceptable, the radiofrequency ablation catheter was introduced into the distal bifurcation area of the main PA.This was then maneuvered within the PA to allow energy delivery to ensure that the electrodes were tightly in contact with the endovascular surface. About two to three ablations at 1-15 W for 240 seconds each point were performed in the distal bifurcation area of the main PA.
16027159|NCT02687477|Procedure|Sham procedure|patient in the sham group will receive sham procedure
16027164|NCT02687438|Device|Steroid-releasing sinus implant|PROPEL (Intersect ENT, Menlo Park, CA) containing 370mcg of mometasone furoate designed for gradual release over 30 days
16027165|NCT02687438|Other|Post-op standard of care|post-op standard of care including debridement, irrigation, and/or topical steroids
16027166|NCT02687425|Drug|Pioglitazone|15mg/day,po
16027167|NCT02687425|Drug|imatinib mesylate|400mg/day,po
16027168|NCT02687412|Procedure|pre-operative assessment, counseling and education|pre-operative assessment, counseling and FT management education
16027169|NCT02687412|Procedure|Preoperative nutritional drink up to 4 h prior to surgery|Preoperative nutritional drink up to 4 h prior to surgery mechanical bowl preparation should not be used
16130230|NCT01933126|Drug|HCG injection|
16027173|NCT02687412|Procedure|avoiding hypothermia|avoiding hypothermia, keeping the intra-operative lowtemperature at 36 ±0.5 degree centigrade; antiemetics at end of anaesthesia.
16027174|NCT02687412|Procedure|Postoperative glycaemic control|Postoperative glycaemic control;
16027175|NCT02687412|Procedure|postoperative nausea and vomiting (PONV) control;|
16027176|NCT02687412|Procedure|early postoperative diet|early postoperative diet(3-6 h after surgery, patients resumed a liquid diet, 12 h after surgery patients began to take solid diet).
16027177|NCT02687412|Procedure|pre-operative fasting at least 8h|
16027178|NCT02687412|Procedure|bowel preparation for traditional surgery|Oral bowel preparations or mechanical bowl until liquid stool
16027179|NCT02687412|Procedure|began to take solid diet after anal exhaust|6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust
16027180|NCT02687399|Other|placebo|After prosthesis cementation and just before knee suture and tourniquet liberation, the patients randomized in the placebo group will receive placebo for inyection sprayed on the exposed tissues of the knee.
16027181|NCT02687399|Biological|TT-173|After prosthesis cementation and just before knee suture and tourniquet liberation, the patients randomized in the treatment group will receive TT-173 for inyection sprayed on the exposed tissues of the knee.
16027182|NCT02687386|Drug|Mitoxantrone packaged EDV (EnGeneIC Delivery Vehicle)|EnGeneIC Delivery Vehicles (EDVs) are nanocells which can be loaded with anti-cancer drugs (mitoxantrone in this study) and targeted to tumor cells. These bacterially-derived nanocells are coated in bispecific antibodies (BsAb) that recognize oncogenic receptors on the tumor cell surface. Once bound to the tumour cell, the targeted and drug-loaded EDVs are endocytosed and release their toxic payload to destroy the tumor cell.
16027183|NCT02687373|Biological|PfSPZ Vaccine|Aseptic, purified, cryopreserved, radiation-attenuated Plasmodium falciparum sporozoites
16027184|NCT02687373|Other|Normal Saline|0.9% Sodium chloride
16027187|NCT02687347|Drug|oral methadone|Oral methadone is the study drug
16027188|NCT02687347|Drug|oral morphine|Oral morphine is the active comparator. It is not a placebo intervention
16027189|NCT02687334|Drug|100% Oxygen|We will investigate the changes of cerebral oxygenation during anesthesia induction of standard general anesthesia with 100% oxygen
16027190|NCT02687321|Other|Determination of CA 125 and HE4, Computed tomography|Blood sample collection to determinate tumor marker found in blood elevated by the presence of cancer recurrence.In case of one or both of tumor markers are elevated, computed tomography examination with intravenous contrast agent of chest and abdomen is performed to detect the recurrence of the disease.
16027191|NCT02687308|Procedure|1 Retrograde radical prostatectomy RRP|This open surgical technique described by Patrick Walsh involves prostatic dissection made from prostatic apex to the bladder neck, so the retrograde direction, the posterior layer of Denonvilliers' fascia is always included with the specimen, and urethrovesical anastomosis usually performed with multifilament interrupted suture
16027192|NCT02687308|Procedure|2 Anterograde radical prostatectomy RRP2A|This open surgical techniques performing radical retropubic prostatectomy using the same technique of minimally invasive surgery, antegrade way, from bladder neck to the apex, with careful bladder neck dissection and preservation, incremental or not careful nervesparing procedures and urethrovesical anastomosis performed by monofilament running suture, described by the Pasadena consensus for the procedure assisted by robot.
16027193|NCT02687295|Dietary Supplement|Thylakoids|
16027194|NCT02687295|Other|Control|
16027195|NCT02687282|Other|Evaluate upper airway changes|Evaluate upper airway changes at several point of time before and after cesarean delivery
16027196|NCT02687269|Drug|Ranolazine|Patients in this arm receive Ranolazine at a dose of 375 mg twice daily in the three days before surgery
16027197|NCT02687269|Drug|Placebo|Patients receive Placebo twice daily in the three days before surgery
16027198|NCT02687256|Device|Extended Wear infusion set|For two of the 4 weeks the Extended Wear insulin infusion set will be used.
16027199|NCT02687256|Device|Standard Infusion set|For two of the 4 weeks the Standard infusion set will be used
16027200|NCT02687256|Drug|Heparin|
16027201|NCT02687243|Device|Interactive Virtual Application|Online application via tablet
16027202|NCT02687230|Drug|MVT-2163|MVT-2163 is administered intravenously as a PET imaging agent
16027203|NCT02687230|Drug|MVT-5873|MVT-5873 is administered intravenously as a non-radioactive blocking agent prior to administration of MVT-2163
16027204|NCT02687217|Drug|oxygen|"Hyperoxygenation ≥50% of oxygen by mask(non-rebreathing) was given through out the surgery.
~Received 6L/min of oxygen through venturimask upto 2 hours in post operative period.
~Hyperoxygenation refers to provision of ≥50% of oxygen by mask(non-rebreathing) through out the surgery."
16027205|NCT02687204|Drug|Twice daily enoxaparin prophylaxis|Patients will have peak and trough steady state anti-Xa levels drawn. For patients with out of range peak levels, real time enoxaparin dose adjustment using a clinical protocol will be performed. Repeat steady state levels will be checked.
16027206|NCT02687204|Drug|Real time dose adjustment|Patients will have peak and trough steady state anti-Xa levels drawn. For patients with out of range peak levels, real time enoxaparin dose adjustment using a clinical protocol will be performed. Repeat steady state levels will be checked.
16027207|NCT02687191|Biological|PF-05230907|PF-05230907 IV bolus injection
16027208|NCT02687178|Drug|Canrenone 50 vs canrenone 100 mg|
16027209|NCT02687165|Drug|Milnacipran and D-cycloserine|Milnacipran augmented by D-cycloserine
16027210|NCT02687152|Other|N-hydroxy-nor-L-arginine|
16027211|NCT02687139|Drug|18F-DCFPyL|
16027212|NCT02687139|Procedure|PET/CT|Positron Emission Tomography - Computed Tomography (PET/CT)
16027213|NCT02687126|Device|Central Venous Catheterization|Ultrasound guided internal jugular venous catheterization
16027214|NCT02687113|Device|CT/US fusion|Fusion of pre-RFA cross-sectional imaging (CT or MRI) and real-time USG using registration function of USG device.
16130231|NCT01933126|Drug|Placebo|
16027215|NCT02687100|Drug|Beclomethasone|beclometasone, 0.8 mg of saline to a volume of 8 mL, three times through the line for suctioning above the cuff: a) after positioning the tube; b) at the arrival in the cardiac intensive care unit; c) just prior to start respiratory weaning
16027216|NCT02687100|Drug|Placebo|patients will receive 8 mL of saline without any drug
16027217|NCT02687087|Device|Visco-ease|19.6 mg/mL of LMS-611
16027218|NCT02687087|Device|Placebo|Physiological Saline
16027219|NCT02687074|Device|HFNC|patients treated with high flow nasal cannula
16027220|NCT02687074|Device|NIV|patients treated with noninvasive ventilation
16027221|NCT02687048|Behavioral|Otago Exercise program|The Otago exercise program (OEP) is an evidence-based falls prevention home-based program. The participants will be instructed by a physiotherapy to do muscle strengthening and balance exercises (to be done 3x/week). The physiotherapist will progress these exercises during 5 home visits to each participant.
16027222|NCT02687048|Behavioral|Mindful meditation|Mindful meditation aims to reorient the individual to the present and broaden self awareness by promoting attention to internal experiences such as bodily sensations, thoughts, emotions, sights or sounds. The participants will be instructed in mindful meditation during 6 hour-long education sessions and will be expected to practice with audio meditations 30 minutes 5 times per week.
16027223|NCT02687035|Device|SAPIEN S3 valve|Transcatheter aortic valve replacement
16027224|NCT02687022|Device|Peramis aberrometry|A non-invasive photographic scan sequence acquired in under 10 seconds
16027225|NCT02687022|Device|iDesign aberrometry|A non-invasive photographic scan sequence acquired in under 10 seconds
16027226|NCT02687009|Drug|Niclosamide|Niclosamide will be taken orally in the morning of each day from day 1-7 prior to surgery for resection of primary tumor. Niclosamide tablets must be chewed well prior to swallowing.
16027227|NCT02686996|Dietary Supplement|carnosine|Carnosine capsules (2g) twice per day for 14 weeks
16027228|NCT02686996|Other|Placebo|Placebo (methylcellulose) capsules for control group identical to intervention capsules and dose
16027229|NCT02686983|Drug|Betamethasone and local anesthetic|Infiltration of the greater occipital nerve .
16027230|NCT02686944|Biological|Intuvax (ilixadencel)|Therapeutic vaccine: allogeneic, proinflammatory dendritic cells, suspension for intratumoral injection
16027231|NCT02686918|Other|Advanced Practice Nurse consultation|
16027232|NCT02686905|Dietary Supplement|Chewable Multivitamin with Iron|Take daily: Chewable Multivitamin with Iron. The chewable vitamins, vitamin chew, or vitamin rapid/quick-melts can be consumed after surgery when cleared by the surgeon.
16027233|NCT02686905|Dietary Supplement|PatchMD Vitamin D3/Calcium Patch|Wear daily: PatchMD Vitamin D3/Calcium patch. The patch can be worn immediately after surgery in order to prevent deficiencies, and we hope to show that this supplementation method can also promote lean muscle mass retention. In addition, due to the malabsorptive properties of bariatric surgery, we hope to show that patients will be more likely to completely absorb the micronutrient via transdermal application than through oral intake.
16027234|NCT02686905|Dietary Supplement|PatchMD Multivitamin Patch|Wear daily: PatchMD Multivitamin patch. The patch can be worn immediately after surgery in order to prevent deficiencies, and we hope to show that this supplementation method can also promote lean muscle mass retention. In addition, due to the malabsorptive properties of bariatric surgery, we hope to show that patients will be more likely to completely absorb the micronutrient via transdermal application than through oral intake.
16027235|NCT02686905|Dietary Supplement|PatchMD B12 Energy Plus Patch|Wear daily: PatchMD B12 Energy Plus patch. The patch can be worn immediately after surgery in order to prevent deficiencies, and we hope to show that this supplementation method can also promote lean muscle mass retention. In addition, due to the malabsorptive properties of bariatric surgery, we hope to show that patients will be more likely to completely absorb the micronutrient via transdermal application than through oral intake.
16027236|NCT02686905|Dietary Supplement|Chewable Calcium|Take daily: Chewable Calcium. The chewable vitamins, vitamin chew, or vitamin rapid/quick-melts can be consumed after surgery when cleared by the surgeon.
16027237|NCT02686905|Dietary Supplement|Quick Dissolve B12|Take daily: Quick Dissolve B12. The chewable vitamins, vitamin chew, or vitamin rapid/quick-melts can be consumed after surgery when cleared by the surgeon.
16027238|NCT02686879|Device|Multifocal contact lenses|
16027239|NCT02686879|Device|Single vision contact lenses|
16027240|NCT02686866|Device|bioelectrical impedance analysis (Bodystat, Quadscan 4000)|
16027241|NCT02686866|Device|dual-energy X-ray absorptiometry (Hologic, Delphi QDR)|
16027242|NCT02686866|Device|hand grip strength|
16027243|NCT02686853|Drug|Liposomal amphotericin B|
16027244|NCT02686840|Drug|sublingual misoprostol|"All patients will receive three doses of sublingual misoprostol every four hours The first dose of misoprostol 800 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of second dose will be given upon sending home.
~Two doses of misoprostol 800 mcg each (four tablets of 200 mcg per dose).
~Paracetamol, eight hourly, will be provided as analgesic or antipyretic.
~A specimen bottle to collect the POC if passed out.
~Two pairs of disposable gloves.
~Pre-filled histopathological examination form to be sent to the laboratory together with the products of conception"
16027245|NCT02686840|Drug|vaginal misoprostol|"All patients will receive three doses of vaginal misoprostol every four hours The first dose of misoprostol 800 mcg will be administrated at the hospital. Then the patient will be observed for 1 hour for any immediate adverse reaction Clear instructions about the method and timing of second dose will be given upon sending home.
~Paracetamol, eight hourly, will be provided as analgesic or antipyretic"
16027246|NCT02686827|Drug|Paricalcitol|Vitamin D3 analogue
16027247|NCT02686827|Drug|Placebo (for paricalcitol)|Injection fluid to mimic paricalcitol injection
16027249|NCT02686788|Drug|TMP001|600mg TMP001 as gelatine capsules á 200mg taken orally twice per day for a duration of 24 weeks
16027250|NCT02686775|Behavioral|Patient coach|
16027251|NCT02686775|Behavioral|Standard care|
16027252|NCT02686762|Drug|Emricasan (5 mg)|Subjects with Non-alcoholic Steatohepatitis (NASH) Fibrosis will be administered orally with emricasan (5 mg) twice a day.
16027310|NCT02686346|Drug|Etoposide|100 mg/m² Days 1-2-3 of Cycles 1-2-3
16134126|NCT01903759|Other|Blood samples|
16027253|NCT02686762|Drug|Emricasan (50 mg)|Subjects with Non-alcoholic Steatohepatitis (NASH) Fibrosis will be administered orally with emricasan (50 mg) twice a day.
16027254|NCT02686762|Drug|Placebo|Subjects with Non-alcoholic Steatohepatitis (NASH) Fibrosis will be administered orally with a matching placebo twice a day.
16027255|NCT02686749|Device|Catheter Ablation|"During ablation, a doctor inserts a catheter through blood vessels into the heart. The doctor looks at the electrical activity of the heart. The catheter is used to determine which areas of the heart are causing AF. After the area is identified, the doctor uses a special machine delivers energy through the catheter to tiny areas of the heart muscle that is causing AF. This energy causes a scar in the tissue which disconnects the pathway of the AF."
16027256|NCT02686749|Drug|FDA approved anti arrhythmic drug|Anti arrhythmic drug medical treatment will be based on treating physicians discretion following standard clinical guidelines
16027257|NCT02686736|Behavioral|Internet-based educational intervention|The intervention will include four educational sessions about risky sexual behaviors and its prevention. The intervention will last one month (one session per week) followed by a three-month follow-up. Teens will be allowed to access to a weekly session at any time and as often as he/she likes.
16027258|NCT02686723|Other|Clinical and biomechanical evaluations|Clinical evaluation : demographics, clinic and functional testing. Biomechanical evaluation : isokinetic, motion analysis of 2 specific motion (drop vertical jump and cutting task) and anterior tibial translation with GnRB
16027259|NCT02686710|Drug|Sevoflurane|
16027260|NCT02686710|Drug|Propofol|
16027261|NCT02686697|Drug|L-Carnosine|
16027262|NCT02686697|Drug|Placebo|
16027263|NCT02686697|Behavioral|Cognitive Training|Cognitive Training for 2 weeks
16027264|NCT02686684|Drug|Dimethyl fumarate|
16027265|NCT02686671|Other|Shoulder clinical examination testing|Shoulder clinical examination including resistive shoulder abduction with and without a humeral traction (Pull Test). Functional status will be measured using the Shoulder Pain and Disability Index (SPADI).
16027266|NCT02686658|Drug|Zimura|Zimura Dose Administration 1
16027267|NCT02686658|Drug|Zimura|Zimura Dose Administration 2
16027268|NCT02686658|Other|Sham|Sham Administration 1
16027269|NCT02686658|Drug|Zimura|Zimura Dose Administration 3
16027270|NCT02686658|Drug|Zimura|Zimura Dose Administration 4
16027271|NCT02686658|Other|Sham|Sham Administration 2
16027272|NCT02686645|Biological|Fecal Microbiota|The fecal microbiota will be by retention enema administered through a rectal tube.
16027273|NCT02686645|Drug|vancomycin|All subjects will be pre-treated with vancomycin 125 mg po qid X 7 days prior to the fecal microbiota.
16027274|NCT02686645|Drug|Loperamide|The subject will take 4 mg of loperamide after the morning bowel prep (approximately 1 hour prior to the procedure) and 2 mg again after the procedure.
16027275|NCT02686645|Drug|metronidazole|If unable to tolerate vancomycin, then it will be substituted with metronidazole 500 mg po tid X 7 days prior to the fecal microbiota.
16027276|NCT02686632|Behavioral|Palatal brushing|Brushing the palate as part of regular oral hygiene habits (behavior) among complete denture wearers.
16027277|NCT02686619|Drug|Cyclosporine|Cyclosporine tablets orally once daily at dose level adapted to maintain concentration at 2 hours after administration (C2): 1000-1500 nanogram per milliliter (ng/mL) during Day 0 to Week 4, and 800-1200 ng/mL during Week 4 to Week 52. For Mycophenoate Mofetil + Sirolimus treatment arm, at Week 12, dose of cyclosporine will be reduced by 50% for 3 days, followed by 1/4 of the dose for 3 days, and then cyclosporine will be stopped.
16027278|NCT02686619|Drug|Daclizumab|Daclizumab 2 milligram (mg) per kilogram (kg) will be administered as intravenous infusion over 15 minute on Day 0 (during the 24 hours preceding renal transplantation) and at a dose of 1 mg/kg on Day14.
16027279|NCT02686619|Drug|Mycophenoate Mofetil|Mycophenoate mofetil 1 gram (g) (2*500mg tablets or 4*250mg capsules) will be given twice daily (daily dose of 2 g) orally for 12 months.
16027280|NCT02686619|Drug|Prednisolone|Prednisolone 250 mg intravenously on Day 0, followed by 0.5 mg/kg orally daily (maximum 40 mg daily) from Day 1 to Day 7, then 0.25 mg/kg orally daily (maximum 20 mg daily), then dose will be stepwise reduced by 2.5 mg per week to reach to a dose level of 10 mg daily and continued up to 6 months and finally drug will be discontinued after 8 months.
16027281|NCT02686619|Drug|Sirolimus|Sirolimus tablets will be given orally from week 12 to week 52, starting with loading dose of 10 mg daily for 2 days followed by 6 mg daily to adapt to trough concentrations of 8-15 ng/mL from week 12 to week 39, and 5-10 ng/mL from week 39 to week 52.
16027282|NCT02686606|Dietary Supplement|Vital 1.5|Oral nutritional supplement
16027283|NCT02686606|Dietary Supplement|Ensure Plus|Oral nutritional supplement
16027284|NCT02686593|Drug|Clofarabine, AraC, mitoxantrone (CLAM)|The combination of clofarabine, cytarabine (Ara-C) and mitoxantrone will be used in patients with AML in first relapse or after failure of first salvage
16027285|NCT02686580|Biological|Collagen paste|Permacol cross-linked collagen paste, 2.5-3.5 mls to be injected into the MRI defined fistula tracts 7-10 days following drainage of the anorectal abscess.
16027286|NCT02686567|Procedure|with TDT|After completion of the anastomosis and further DS construction if necessary, the surgeon would be notified to implement the intervention based on the randomizing results. In this group, a silicone tube (28Fr, Sumitomo Bakelite Co, Japan) was inserted through the anus and the tip of the tube was placed approximately 5 cm above the anastomosis at the end of the surgery in patients from the TDT group. The tube was fixed with a skin suture and connected to a drainage bag. TDT was planed to remove 3-7 days after surgery and early removal was allowed if the patient experienced intolerable pain.
16027287|NCT02686567|Procedure|without TDT|After laparoscopic anterior resection and double-stapling technique anastomosis were finished, none additional proceduce was done.
16027288|NCT02686554|Other|Neuropsychological assessment|The patients perform tests to assess their cognitive abilities
16027311|NCT02686346|Drug|Carboplatine|max 800mg Day 2 of Cycles 1-2-3
16027312|NCT02686346|Drug|Ifosfamide|5 g/m² Day 2 of Cycles 1-2-3
16027313|NCT02686333|Other|Meditation|10-15 minutes of individually conducted medication practices (silent meditations, guided meditations, body scans, gentle arm movement exercises).
16027314|NCT02686307|Procedure|ICD Implant|Implantation of an implantable cardioverter/defibrillator
16027315|NCT02686294|Drug|HL151|Test drug : HL151. 1T, once a day oral administration, for 4 days
16027289|NCT02686541|Device|Atherectomy followed by Drug Eluting Balloon (DEB)|"Patient will undergo an intervention under anaesthesia. After pre-arthrectomy Intravascular ultrasound (IVUS) of the affected arterial segment, patient will undergo treatment with Arthrectomy, followed by post-arthrectomy IVUS analysis.
~Following arthrectomy, the affected vessel will be treated by supplementary Ranger Drug Eluting Balloon (DEB).
~During post-procedure, patients will be started on dual antiplatelets for 3 month post intervention followed by Aspirin for life unless contraindicated. Clinical follow-up, duplex ultrasound (to assess for re-stenosis) and Ankle Brachial Pressure Index (ABPI) will be performed at 1-month, 6-month and 12-month. Assessment of the symptoms, pulse, and clinical patency will be performed at each visit."
16027290|NCT02686528|Other|Hip Precautions|Hip precautions are functional limitations of the hip replacement prescribed to patients for the first six weeks after surgery and are no hip flexion past 90º, no crossing the legs, and no twisting at the waist.
16027291|NCT02686528|Other|No Hip Precautions|Patients will not be prescribed hip precautions in the first 6 weeks after surgery. The hip precautions that will no longer be prescribed are: no hip flexion past 90º, no crossing the legs, and no twisting at the waist.
16027292|NCT02686515|Device|single-task balance training|The framework of progressive balance exercises in the single-task training will include body stability tasks (Stance activities), transitional activities (Sit to stand and walk), and body transfer tasks (Gait activities). These exercises target various systems for balance control, such as stability limits (standing with changes in base of support and weight shifting), sensory orientation (standing on compliant surfaces with eyes open and eyes closed), postural responses (reactions to balance perturbation, sit to stand and walk), and gait (treadmill walking with increasing speed).
16027293|NCT02686515|Device|dual-task balance training|Three cognitive tasks will be used for dual-task training while standing and walking: auditory discrimination tasks, verbal fluency tasks, and calculation tasks. In addition, motor tasks such as carrying a bag, holding a glass of water, alternating hand movement, carrying a tray with glasses, or getting keys out of a pocket will also be included as added tasks.
16027294|NCT02686502|Behavioral|Lifestyle|As part of the intervention Mode 2 and 3 subjects will use various mobile health applications including heart rate monitor, global positioning system, diet diary, and weight, sleep and mood monitors. They will also be offered music streaming service for e.g. motivation and relaxation.
16027295|NCT02686489|Other|Heated humidification|Water vapor (molecular water) will be added to the inspired gas of the spontaneously breathing tracheostomy patient by using the Fisher & Paykel Healthcare, (Auckland, New Zealand) AIRVO 2 Humidification System. The AIRVO 2 will provide respiratory gas flow at 2-60 L/min) that is conditioned to 37° C, 34° C, or 31° C (based on patient comfort) and 100% relative humidity via a heated breathing circuit.
16027296|NCT02686489|Other|Cool bland aerosol|Aerosol (particles of water suspended in gas) generated by a flow of gas through a pneumatically powered large volume jet nebulizer filled with sterile water (for inhalation) attached to a gas source via a flowmeter set between 10-15 L/min will add moisture to the inspired gas of the spontaneously breathing tracheostomy patient. The cold bland aerosol set-up will consist of corrugated aerosol tubing with one end connected to the nebulizer output port and the other end connected to a tracheostomy mask.
16027297|NCT02686476|Drug|Empagliflozin|group I (n = 50): T2DM patients receiving standard care for T2DM (metformin, sulfonylurea, DPP-4 inhibitor or insulin, in any combination) plus 10 mg of Empagliflozin per day
16027298|NCT02686463|Procedure|Laparoscopy|Laparoscopy is an operation performed in the abdomen or pelvis through small incisions (usually 0.5-1.5 cm) with the aid of a camera. It can either be used to inspect and diagnose a condition or to perform surgery.
16027299|NCT02686463|Procedure|Laparotomy|A laparotomy is a surgical procedure involving a large incision through the abdominal wall to gain access into the abdominal cavity. It is also known as a celiotomy.
16027300|NCT02686437|Other|TheraBand Kinesiology Tape|Kinesiology taping technique is designed to target muscles and lymphatic system. Limited research is available for specific conditions, including low back pain, but it is theorized to correct muscle function by inhibiting or facilitating the muscle, improve blood flow, reduce pain, and improve joint alignment.
16027301|NCT02686411|Behavioral|Participant Questionnaires|"Participants complete 2 questionnaires about satisfaction and impression of care received in the PCU, how much distress experienced in past week, and level of comfort with being transferred to the PCU. Questionnaires take about 15 minutes to complete.
~Two (2) weekdays after completion of first set of questionnaires, 2 questionnaires completed about overall satisfaction and impression of care received in the PCU, and how much distress experienced in the past few days. One (1) questionnaire asks comparison of care received with the palliative care consult, to the care received in the PCU. These questionnaires should also take about 15 minutes to complete."
16027302|NCT02686411|Behavioral|Caregiver Questionnaires|"Caregiver completes questionnaire about their demographic information. It should take about 5-10 minutes to complete.
~Caregiver then completes 2 questionnaires about their overall satisfaction and impression of care their family member or friend received in the PCU, how much distress experienced in past week, and level of comfort felt with family member/friend being transferred to the PCU. These questionnaires should take about 15 minutes to complete.
~Two (2) weekdays after completion of first set of questionnaires, same questionnaires completed about overall satisfaction and impression of care their family member or friend received in the PCU and how much distress experienced in the past few days. One (1) questionnaire asks caregiver to compare the care their family member or friend received with the palliative care consult, to the care their family member/friend received in the PCU. These questionnaires should take also about 15 minutes to complete."
16027303|NCT02686398|Biological|Fluad|
16027304|NCT02686398|Biological|Agrippal|
16027305|NCT02686385|Drug|Prednisolone|
16027306|NCT02686385|Drug|N-Acetylcysteine|NAC (N-Acetylcysteine) dosing-Loading dose: 150 mg/kg IV; mix in 200 mL of 5% dextrose in water (D5W) and infuse over 1 h Dose 2: 50 mg/kg IV in 500 mL D5W over 4 h Dose 3: 100 mg/kg IV in 1000 mL D5W over 16 h
16027307|NCT02686372|Other|Biological: HBV antigen specific TCR redirected T cell|Subjects will receive escalating doses of HBV antigen specific TCR redirected T cell infusion.
16027308|NCT02686359|Biological|sample|
16027309|NCT02686346|Drug|Brentuximab Vedotin|"Phase I:
~Cohort K: BV on Day 1: 1.2 mg/kg (cycle 1-3) and 1.8 mg/kg (cycle 4) Cohort K+1: BV on Day 1: 1.8 mg/kg (cycle 1-3) and 1.8 mg/kg (cycle 4) Cohort K-1: BV on Day 1: 0.8 mg/kg (cycle 1-3) and 1.8 mg/kg (cycle 4)
~Phase II:
~BV on Day 1: at the Maximal Tolerated Dose (MTD) defined at Phase I"
16027316|NCT02686294|Drug|TALION tab.|Reference drug : TALION tab. 1T, twice a day oral administration, for 4 days
16027317|NCT02686281|Drug|GMC-252-L-Lysine|
16027318|NCT02686281|Other|Placebo|
16027319|NCT02686255|Other|complete blood count|complete blood count during follow up in the heart institute
16027320|NCT02686242|Procedure|spinal anesthesia|bupivacaine injected by spinal puncture
16027321|NCT02686242|Procedure|general anesthesia|general anesthesia with intubation
16027322|NCT02686229|Other|no interventions|
16027323|NCT02686216|Drug|F-18 THK-5351|Totally 24 subjects age 20-90 including 12 healthy cognitively intact subjects and 12 probably AD patients with NINCDS-ADRDA criteria. For disease subjects, caregiver should be able to report activities of daily living and their mental status. Patient should be able to give informed consent or have a caregiver give consent with subject assent.
16027324|NCT02686203|Device|B-Cure Laser Pro and needles|"Treatment will consist of acupuncture applied by a combination of B-Cure Laser Pro, an approved handheld, portable device emitting low level laser, and needles using two to four acupoints (The Investigational Therapy).
~The Investigational Therapy will be administered by a treating therapist designated by the Sponsor who is experienced in employing the treatment"
16027325|NCT02686190|Other|Luxtherapy|
16027326|NCT02686177|Drug|Liraglutide|
16027327|NCT02686177|Drug|Metformin or sulfonylurea|
16027328|NCT02686164|Drug|Lenvatinib|Lenvatinib 24 mg (as one 4 mg and two 10 mg capsules) will be administered orally once daily with 240 mL (8 fluid oz) of water each morning, starting on Cycle 1 Day 1, in 28-day cycles.
16027329|NCT02686164|Drug|Midazolam|Midazolam syrup 4 mg will be administered orally after an overnight fast on Cycle 1 Day -3 and concurrently with lenvatinib on Day 1 and Day 14 of Cycle 1. Participants will have to remain fasting for 2 hours after each dose of midazolam.
16027330|NCT02686151|Drug|Letrozole|used after oocyte retrieval
16027331|NCT02686151|Drug|Polygeline|used after oocyte retrieval
16027332|NCT02686151|Drug|Sodium Chloride|used after oocyte retrieval
16027333|NCT02686151|Drug|dexamethasone|used after oocyte retrieval
16027334|NCT02686138|Drug|Tenapanor|
16027335|NCT02686138|Drug|Placebo|
16027336|NCT02686125|Device|Deep Brain Stimulation (DBS)|Subjects receiving Deep Brain Stimulation (DBS) for the treatment of their dystonia symptoms will be offered participation in this registry.
16027337|NCT02686099|Device|SternaLock 360|Sternal closure with SternaLock 360
16027338|NCT02686099|Device|Wire Cerclage|Sternal closure with standard wire cerclage
16027339|NCT02686086|Device|vibrating mesh nebuliser|The Aerogen Solo vibrating mesh nebuliser is an approved 13 485 class II medical device (CE marked) nebuliser licenced for the delivery of physician-prescribed medications for inhalation which are approved for use with a general purpose nebuliser. It has been shown in previous laboratory and clinical studies to have superior drug delivery to standard jet nebulisers.
16027340|NCT02686086|Device|Standard hospital jet nebuliser|"The standard hospital jet nebuliser refers to the nebuliser in clinical use currently throughout Beaumont Hospital and used for the administration of nebulised medications"
16027341|NCT02686086|Drug|Combined salbutamol 2.5 mg and ipratropium 0.5mg nebule|All patients admitted to hospital with an exacerbation of COPD are administered nebulised bronchodilators (salbutamol 2.5mg/ipratropium 0.5mg combination) as standard of care
16027342|NCT02686060|Device|0.2 micron positively charged PALL Corporation filters and 1.2 micro IV in-line filters used for lipid administration|
16027343|NCT02686047|Device|HYAJOINT Plus|The patients in the HYAJOINT Plus group received one intraarticular injection of 3 ml HYAJOINT Plus (2% microbial fermented HA, 20 mg/ml).
16027344|NCT02686047|Device|Synvisc-One|The Synvisc-One group received one injection of 6 ml Synvisc-One (0.8% avian derived HA, 8 mg/ml).
16027345|NCT02686034|Device|gammaCore-S|At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment, or take their usual rescue medication.
16027346|NCT02686034|Device|gammaCore-S Sham|At onset of migraine pain, the subject self-administers a bilateral treatment with the gammaCore nVNS Sham device (2 minutes on the right side, and 2 minutes on the left side). If their headache pain has not improved after 15 minutes, they administer another bilateral treatment with the Sham device. If they are not pain-free at 2 hours, they have the option to administer a third bilateral treatment with the Sham device, or take their usual rescue medication.
16027347|NCT02686021|Drug|Metamizole and Ibuprofen|Metamizole (1000mg) plus Ibuprofen (400mg) 15 minutes prior to surgery, at 6 postoperative hours, and at 12 postoperative hours
16027348|NCT02686021|Drug|Metamizole and Placebo|Metamizole (1000mg) plus placebo 15 minutes prior to surgery, at 6 postoperative hours, and at 12 postoperative hours
16027349|NCT02686021|Drug|Ibuprofen and Placebo|Ibuprofen (400mg) plus placebo 15 minutes prior to surgery, at 6 postoperative hours, and at 12 postoperative hours
16027350|NCT02686008|Drug|Olaparib|Patients will receive olaparib administered at 300 mg bid x 14 days orally
16027351|NCT02685995|Device|VectorFlow TDC|TDC insertion with VectorFlow will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol. Following TDC insertion, the catheter may be used immediately. The goal of HD is typically to achieve a target effective blood flow of 300mL/min within the first 3 hemodialysis sessions. The dialysis records from each of the first three HD sessions will be reviewed by the study coordinator for (A) Blood flow rate (QB), (B) Arterial and venous lumen pressures, (C) Kt/V, and (D) Urea reduction ratio (URR). Additionally, need and use of thrombolytic infusion (ie t-PA) (other than single dose injection) to restore or improve patency and/or need for catheter exchange.
16027387|NCT02685722|Other|Gel group|This study for a six-month trials,Randomized, open, and parallel comparison before and after its own,Stage test includes screening stage, stochastic screening of more than a month difficult to heal wounds 20 people.By generating a random number of principle,observed and compared Gel group patients may be no efficacy.
16027388|NCT02685709|Drug|Octreotide capsules|Octreotide capsules 40mg/day, 60mg/day, 80mg/day
16027389|NCT02685709|Drug|Injectable Somatostatin Analogs (octreotide or lanreotide)|Octreotide - 10, 20, 30mg. Lanreotide 60,90, 120mg.
16027352|NCT02685995|Device|Palindrome TDC|TDC insertion with Palindrome will be in accordance with its FDA-approved indication under moderate sedation or general anesthesia with local anesthesia using 1% lidocaine in per institutional protocol. Following TDC insertion, the catheter may be used immediately. The goal of HD is typically to achieve a target effective blood flow of 300mL/min within the first 3 hemodialysis sessions. The dialysis records from each of the first three HD sessions will be reviewed by the study coordinator for (A) Blood flow rate (QB), (B) Arterial and venous lumen pressures, (C) Kt/V, and (D) Urea reduction ratio (URR). Additionally, need and use of thrombolytic infusion (ie t-PA) (other than single dose injection) to restore or improve patency and/or need for catheter exchange.
16027353|NCT02685982|Device|Rhythmic Sensory Stimulation|"The stimulation consists of 30 minutes of daily stimulation with specially composed relaxing music tracks embedded with gamma frequency sounds of 30-70 Hz range.
~In this study, the stimuli will be delivered with a portable sound device called Sound Oasis Vibroacoustic Therapy System (VTS-1000) unit, which is a low-voltage consumer product that has two built in mid to high frequency speakers and one built in low frequency (subwoofer-type) speaker. The low frequency sounds played by the subwoofer speaker is experienced as vibrotactile vibration. Although the Intervention of Interest in this study is the Rhythmic Sensory Stimulation with low-frequency sounds, the efficacy of the Sound Oasis VTS-1000 device to deliver the intervention will also be subject to observation."
16027354|NCT02685969|Procedure|18F-Flutemetamol & 18F-FDG|Characterization of cerebral amyloid deposition with 18F-Flutemetamol PET and glucose metabolism 18F-FDG PET.
16027355|NCT02685956|Device|Vela Sentosa SA HSV1/2 Qualitative PCR Test|medical device test using Vela Sentosa SA HSV1/2 Qualitative PCR Test
16027356|NCT02685943|Behavioral|Psychotherapy|
16027357|NCT02685930|Behavioral|Antibiotic de-escalation by ICU stewardship team with decreased exposure to broad spectrum antibiotics and shorter duration of therapy|ICU stewardship team will provide recommendations to the ICU team regarding antibiotic de-escalation and duration of therapy in attempts of improving antibiotic stewardship practices without compromising patient outcomes.Recommendations will be based on patient showing clinical improvement combined with microbial culture data.
16027358|NCT02685917|Procedure|Microfracture without Collagen Augmentation|Cartifill applied for collagen augmentation
16027359|NCT02685917|Procedure|Microfracture with Collagen Augmentation|Cartifill applied for collagen augmentation
16027360|NCT02685904|Biological|ENIA11|
16027361|NCT02685904|Biological|Placebo|
16027362|NCT02685891|Other|Playing tones during deep sleep|Playing tones time locked to slow waves (Duration:50ms, volume: 50dB)
16027363|NCT02685891|Other|sham condition|in the sham condition, no tones will be played
16027364|NCT02685865|Device|FCSEM Stent|Hot Axios Fully covered self-expandable metal stent - Boston Scientific
16027365|NCT02685865|Device|Plastic Stent|7 French 4 cm double pigtail plastic stent - Cook 7 French 4 cm double pigtail plastic stent - Boston Scientific
16027366|NCT02685852|Drug|Exenatide|Exenatide at a dose of 5 mcg
16027367|NCT02685852|Drug|Acarbose|Acarbose at a dose of 25 mg
16027368|NCT02685852|Drug|Exenatide Placebo|Placebo for Exenatide
16027369|NCT02685852|Drug|Acarbose Placebo|Placebo for Acarbose
16027370|NCT02685839|Device|Intelligent POWER Rehabilitation Cluster Machine|
16027371|NCT02685839|Other|general physical therapy|
16027372|NCT02685826|Drug|Durvalumab|single use vials administered via intravenous infusion
16027373|NCT02685826|Drug|Lenalidomide|capsules for oral administration
16027374|NCT02685826|Drug|Dexamethasone|tablets for oral administration
16027375|NCT02685787|Behavioral|Psychosocial Intervention|The caregiver in the intervention arm will meet the counselors six times. The first and the last sessions will be attended by the caregiver only whereas the remaining four sessions will be attended by the caregiver and other family members. Interventions will be tailored for the caregivers based upon: 1) depression and anxiety; 2) burden; 3) self care and health-related behavior; 4) social support; and 5) behavioral symptoms. The design and management of the structured intervention will follow a published counseling caregiver manual, based on the experiences matured at New York University. Every session will be documented.
16027376|NCT02685787|Behavioral|Educational Intervention on AD|"The caregiver enrolled in this arm:1) will not receive counseling or support; 2) will participate to group sessions; 3) the six hours sessions will divulge information on AD using a slide-show. Each session will focus on the following topic: (a) diagnosis and treatment b) cognitive deficit management, c) behavioral disturbance management, d) daily living management, e) non-pharmacological treatment, f) legal issues and available health and social services.
~Additionally, contrary to other arm, caregivers will not receive any telephone calls after the end of the educational sessions."
16027377|NCT02685774|Drug|Duvie Tab. 0.5mg, Glucophage XR Tab. 500mg|Duvie Tab. 0.5mg 1T, Glucophage XR Tab. 500mg 2T oral administration
16027378|NCT02685774|Drug|CKD-395 0.25/500mg|CKD-395 0.25/500mg 2T oral administration
16027379|NCT02685761|Procedure|Midline Vertical|Cesarean section performed using a midline vertical skin incision, located between the umbilicus and pubis
16027380|NCT02685761|Procedure|High Transverse|Cesarean section performed using a transverse skin incision located above the pannus
16027381|NCT02685748|Drug|Aspirin|1000 mg pd in two doses
16027382|NCT02685748|Drug|Placebo|two pills twice a day (instead of aspirin and pantoprazole)
16027383|NCT02685748|Drug|Pantoprazole|Pantoprazole 40 mg/pd in two doses, for gastric protection
16027384|NCT02685735|Drug|Gabapentin|Drug treatment will begin 2 weeks prior to surgery and continue 3 weeks afterwards. Subjects randomized to gabapentin will receive 900 mg/day for the first week, 1800 mg/day for the next 3 weeks, and 900 mg/day for the last week.
16027385|NCT02685735|Drug|Placebo|Drug treatment will begin 2 weeks prior to surgery and continue 3 weeks afterwards. Subjects randomized to gabapentin will receive 900 mg/day for the first week, 1800 mg/day for the next 3 weeks, and 900 mg/day for the last week.
16027386|NCT02685722|Biological|UC-MSCs Gel group|This study for a six-month trials,Randomized, open, and parallel comparison before and after its own,Stage test includes screening stage, stochastic screening of more than a month difficult to heal wounds 20 people.By generating a random number of principle,Observation of UC-MSCs Gel group patients efficacy, safety and tolerability of selective parameter.
16027390|NCT02685709|Drug|Cabergoline|Cabergoline - 3.5mg/week
16028477|NCT02677571|Procedure|Pectorals nerve block|
16027391|NCT02685696|Device|Alexis O Retractor|A newly developed abdominal wall retractor for Caesarean Section is the Alexis O Ring which is formed of 2 rings and a interconnecting plastic polyurethane sheath where the flexible inner ring is placed into the abdomen and where the rigid outer ring is rolled to create tension on the plastic sheath providing 360° abdominal wound retraction with simultaneously a tamponade effect whilst covering the abdominal wound during the Caesarean Section and delivery of the baby.
16027392|NCT02685696|Device|Metal Retractor|The traditional self-retaining metal Collins Caesarean Wound Retractor.
16027393|NCT02685683|Drug|GED-0301|During Induction period patient will receive mongersen 160 mg daily for 12 weeks. This study also offers subjects the option to continue with maintenance treatment at the discretion of the Investigator, beginning after the Week 12 Visit with alternating no IP for 4 weeks, followed by mongersen (GED-0301) 160 mg QD for 4 weeks, up through the Week 52 Visit during the Maintenance Period. At Week 52, subjects who have achieved an endoscopic improvement of >50% from baseline based on the SES-CD, as assessed by the central reader, and clinical improvement (HBI <7), will have the option to continue receiving treatment for an additional year, up through Year 2 (ie, the Week 100 Visit).
16027394|NCT02685670|Biological|anti-CD19 CAR-T|Ex vivo-expanded autologous T cells modified to express CD19 CAR
16027395|NCT02685670|Drug|Fludarabine|
16027396|NCT02685670|Drug|Cyclophosphamide|
16027397|NCT02685657|Drug|Drug: Selumetinib|
16027398|NCT02685657|Drug|Doxorubicin|
16027399|NCT02685657|Drug|Cyclophosphamide|
16027400|NCT02685657|Drug|Docetaxel|
16027401|NCT02685644|Procedure|Laparoscopic removal of cysts|Women with endometrioma lesions will undergo laparoscopic removal. Cysts will be enucleated with blunt dissection of the cyst capsule and following traction, counter traction maneuver. Bipolar coagulation will be used sparsely and suturing will be the predominant choice for achieving bleeding control.
16027402|NCT02685631|Other|Yttrium-90 Resin Microspheres|Data collection into the RESIN registry
16027403|NCT02685618|Drug|Iloprost|
16027404|NCT02685618|Drug|Saline|
16027405|NCT02685618|Device|Phillips M1006B, offset by -10mmHg|Administration of blood pressure module M1006B: offset by -10 mmHg
16027406|NCT02685618|Device|Philips M1006B, No offset|Administration of blood pressure module M1006B: No offset
16027407|NCT02685605|Procedure|Standard surgery|
16027408|NCT02685605|Radiation|Intraoperative radiotherapy|Dose to applicator surface: 20-30 Gy; Carl Zeiss INTRABEAM System. IORT with a surface dose of 30 Gy is recommended.Should the proximity to any risk structure not allow to apply 30 Gy, a dose reduction by up to 10 Gy (resulting in a surface dose of 20 Gy) is allowed.
16027409|NCT02685605|Radiation|Radiochemotherapy|EBRT to 60 Gy plus 75 mg/m2/d temozolomide
16027410|NCT02685605|Drug|Temozolomide|Adjuvant chemotherapy with 150-200 mg/m2/d temozolomide per cycle (5/28 days).
16027411|NCT02685592|Drug|5-aminolevulinic acid nanoemulsion|A 1 millimeter thick layer of 5-aminolevulinic acid nanoemulsion light sensitizing gel is applied on the skin and let to absorb 3 hours before illumination.
16027412|NCT02685579|Other|Treatment of Obstructive Sleep Apnea-CPAP/BiPAP etc./Diet/surgery/life style changes|
16027413|NCT02685566|Device|FFDM Plus DBT|FujiFilm Aspire Cristalle System
16027414|NCT02685566|Device|FFDM|FujiFilm Aspire Cristalle System
16027415|NCT02685553|Device|NIR|Laparoscopic use of NIR
16027416|NCT02685514|Device|HIFU Graves|The HIFU treatment technique will be applied to the recruited participants
16027417|NCT02685501|Other|no intervention|
16027418|NCT02685488|Device|Transcranial Ultrasound Power|Transcranial ultrasound will be to stimulate at the right fronto-temporal cortex. 30 seconds of stimulation at 500 kHZ with duty cycle 0.24% and pulse rate frequency at 40 Hz.
16027419|NCT02685488|Device|Transcranial Ultrasound Sham|"Transcranial ultrasound will be used without power for a sham condition."
16027420|NCT02685475|Drug|Axillary Brachial Plexus Blocks|All patients received ultrasound-guided axillary brachial plexus block (ABPBs) with the mixture of 10 mL lidocaine 2% and 20 mL bupivacaine 0.5%.
16027421|NCT02685462|Drug|Rosuvastatin|
16027422|NCT02685462|Drug|Atorvastatin|
16027423|NCT02685462|Drug|Simvastatin|
16027424|NCT02685462|Drug|Digoxin|
16027425|NCT02685462|Drug|Caffeine|
16027426|NCT02685449|Drug|Insulin glulisine|A kind of study bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial
16027427|NCT02685449|Drug|Insulin aspart|A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial
16027428|NCT02685449|Drug|Insulin lispro|A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial
16027429|NCT02685436|Drug|Omeprazole and domperidone|wheezy infants with abnormal MII-pH or reflux esophagitis will be given omeprazol(10mg/once/day) and domperidone (0.2mg/kg/day t.d.s)
16027430|NCT02685423|Behavioral|Binocular deprivation 10 days|Research participants will be asked to live 10 days in an experimentally-controlled dark environment.
16027431|NCT02685423|Behavioral|Vision training|Subjects will play a video game on their VR headset for 24 minutes per day, followed by 20 minutes of binocular experience with a brightness-reducing filter over the non-amblyopic eye.
16027432|NCT02685410|Other|One Night Stan Prototype|The One Night Stan prototype, will be a social network game with the goal of risk reduction and HIV/STI prevention in young black women.
16027433|NCT02685397|Drug|Leuprolide Acetate|Luteinizing hormone releasing hormone (LHRH) agonist administered by subcutaneous injection. Only one of the LHRH agonists described here will be administered during the course of treatment.
16027434|NCT02685397|Drug|Goserelin Acetate|Luteinizing hormone releasing hormone (LHRH) agonist administered by subcutaneous injection. Only one of the LHRH agonists described here will be administered during the course of treatment.
16027435|NCT02685397|Drug|Triptorelin|Luteinizing hormone releasing hormone (LHRH) agonist administered by subcutaneous injection. Only one of the LHRH agonists described here will be administered during the course of treatment.
16027436|NCT02685397|Drug|Enzalutamide|Anti-androgen medication for the treatment of metastatic castration-resistant prostate cancer. 160 mg (four 40 mg capsules) taken as a single oral daily dose, with or without food, until disease progression.
16027552|NCT02684448|Procedure|Inguinal Hernia Repair|Inguinal (unilateral or bilateral) hernia repair
16027437|NCT02685397|Radiation|Stereotactic Body Radiation Therapy|Stereotactic body radiation therapy (SBRT) is a treatment modality in radiation oncology that delivers a very high dose of radiation to the tumour target with high precision using a single or a small number of fractions.
16027438|NCT02685384|Other|Medicaid Expansion|There will be no direct intervention, but rather an observation of change based on whether a state expanded Medicaid or not
16027439|NCT02685371|Behavioral|Breathing|Subjects will have to breath 1- Spontaneously 2- to produce a negative pressure of -15 to -30 cm of water and 3- to produce a negative pressure more than -30 cm of water.
16027440|NCT02685358|Behavioral|Clinician-Supported PTSD Coach|Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consists of 4 brief sessions over 8 weeks.
16027441|NCT02685358|Behavioral|Primary Care Mental Health Integrated Care as Usual|Existing primary care mental health integrated treatment will serve as the comparison condition
16027442|NCT02685345|Drug|DS-8500a 25 mg|
16027443|NCT02685345|Drug|DS-8500a 75 mg|
16027444|NCT02685345|Drug|placebo|
16027445|NCT02685332|Radiation|Stereotactic Radiation|"Stereotactic Body Partial Breast irradiation Step No. Fractions Dose per fraction
~-1 1 20 0 (starting) 1 22.5
~1 26.5
~1 30"
16027446|NCT02685319|Procedure|muscle biopsy|a muscle sample will be taken from the mid-thigh (Vastus Lateralis) and analyzed
16027447|NCT02685306|Biological|Bavituximab|12 weekly doses of bavituximab given on Days 1, 8,15,22,29, 36, 43, 50, 57, 64, 71, 78
16027448|NCT02685306|Drug|Taxane|12 weekly doses of taxane on Days 1, 8,15,22,29, 36, 43, 50, 57, 64, 71, 78
16027449|NCT02685293|Drug|GFF MDI (PT003)|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI)
16027450|NCT02685293|Drug|Placebo MDI|Placebo Metered Dose Inhaler (MDI) for Glycopyrronium and Formoterol Fumarate Inhalation Aerosol
16027451|NCT02685280|Device|Medtronic Restore Advanced 37713|Rechargeable neurostimulators are implanted when the non-rechargeable neurostimulators are end-of-life.
16027452|NCT02685267|Drug|Docetaxel|
16027453|NCT02685267|Drug|Enzalutamide|
16027454|NCT02685267|Drug|Prednisone|
16027455|NCT02685254|Behavioral|Structural skills training group|Weekly 2-hours sessions for 14 weeks follow the Norwegian translation of the Swedish version of the ADHD skills training manual/workbook (Hesslinger 2010; Hirvikoski 2011; Morgensterns 2015) which is based on an adaption of Marsha Linehan's dialectical behavior therapy (DBT) for borderline personality disorder into a group-based skills training program for adults with ADHD (Hesslinger 2002; Philipsen 2007). The groups embrace 7 - 10 participants, and two group leaders trained in group therapy, cognitive-behavioral treatment or DBT. Each session contains an initial short repetition and feedback on the previous session, followed by review of the homework during the first hour. After a break, a new topic with exercises and homework for the following week is introduced.
16027456|NCT02685254|Other|Treatment as usual|Treatment as usual includes clinical management and/or medication, and or supportive counselling by physician or nurse
16027457|NCT02685228|Drug|Decitabine|decitabine 5mg/m2,d1-d5;
16027458|NCT02685228|Drug|Gemcitabine|gemcitabine 1.0g/m2, d8,d15,d22
16027459|NCT02685202|Device|Mandibular advancement splint|A mandibular advancement splint (MAS), functions by comfortably positioning the patient's mandibular in a forward position, clearing the obstructed airway during sleep.
16027460|NCT02685189|Other|Previous exposure to stannsoporfin|No intervention in this protocol
16027461|NCT02685176|Device|Charcoal Heater (STK Heatpac, Emergco Tech Solutions, B.C.)|A heater (STK Heatpac) will be used in the active warming arms of the study.
16027462|NCT02685176|Other|No heat|No active heating provided post cooling
16027463|NCT02685163|Other|Antioxidant ice-cream|Narutal Antioxidant ice-cream
16027464|NCT02685163|Other|Control Ice-cream|Natural Control Ice-cream
16027465|NCT02685150|Device|Endoscopic Tri-Modal Imaging|Endoscope that combines white light imaging (WLI) with autofluorescence imaging (AFI) and narrow band imaging (NBI).
16027466|NCT02685150|Drug|Omeprazole|Omeprazole is one kind of proton-pump inhibitors. All participants undergo standard proton-pump inhibitor (PPI) tests for two weeks with Omeprazole, 20mg twice a day.
16027467|NCT02685150|Other|Analysis of gastric juice|Analysis of gastric juice including routine, biochemical and microbiological analysis.
16027468|NCT02685137|Drug|stannsoporfin|Intramuscular injection of stannsoporfin to treat jaundice.
16027469|NCT02685137|Other|Sham Injection|nothing
16027470|NCT02685124|Dietary Supplement|Orange juice|Three days before the start of the study, all participants will restrict their diet avoiding citrus fruits (orange, tangerine, lemon) and its derivatives (washout period), red fruits and vegetables (strawberry, red lettuce, red grape, tomate). The day before the sample collection will be provided a controlled dinner. A fasting for 8 hours will be required before blood and urine collection. All participants will divided into three groups: I (Cara Cara), II (Bahia), III (Isocaloric control drink). They will consume 250 ml of each drink twice daily for 7 consecutive days, with a washout period of 7 days among each intervention.
16027471|NCT02685111|Drug|Filgrastim|Filgrastim (Gracinᵀᴹ) is administered at the D3, D5, D7, D9, and D11 of each cycle. A dose of 5 μg/kg/day filgrastim is administered S.C. either as a bolus injection or as a continuous injection. Administer into the outer upper arm, abdomen (except within 2 inches of navel), front middle thigh, or the upper outer buttocks area.
16027472|NCT02685111|Drug|Peg-filgrastim|Pegfilgrastim (Neulastaᵀᴹ) is administered at the D2 of each cycle. A dose of 6mg once a cycle is administered S.C., 24 (± 2) hours after completion of chemotherapy.
16027473|NCT02685098|Biological|Allogeneic bone marrow derived mesenchymal stem cells|Injection of HLA-A2+ and/or gender mismatched allogeneic MSCs above the site of amputation and into the anterior tibialis muscle (ATM) of patients scheduled for semi-elective lower extremity major amputation at 7 days before amputation.
16027474|NCT02685085|Drug|Misoprostol ( Prostaglandin E2)|
16027475|NCT02685085|Device|Foley's catheter|
16027476|NCT02685072|Drug|Progesterone (200 mgs BID)|Transdermal Nicotine Patch (TNP) + Progesterone
16027477|NCT02685072|Drug|Placebo|TNP + Placebo
16027553|NCT02684435|Drug|Perflutren lipid microsphere|Dosing per approved package label
16135131|NCT01896349|Drug|Lithium|
16027478|NCT02685059|Drug|MEDI4736 (Anti PD-L1)|"MEDI4736 1.5g total i.v. every 4 weeks
~As monotherapy for the first two weeks (0.75g absolute) (part 1) followed by:
~MEDI4736 in combination with nab-paclitaxel 125 mg/m² every week for 12 weeks (part 2) followed by
~MEDI4736 in combination with epirubicin 90mg/m² plus cyclophosphamide 600 mg/m² every 2 weeks for 4 cycles (part 3)."
16027479|NCT02685059|Drug|Placebo|"Placebo i.v. every 4 weeks
~As monotherapy for the first two weeks (0.75g absolute) (part 1) followed by:
~Placebo in combination with nab-paclitaxel 125 mg/m² every week for 12 weeks (part 2) followed by
~MEDI4736/Placebo in combination with epirubicin 90mg/m² plus cyclophosphamide 600 mg/m² every 2 weeks for 4 cycles (part 3)."
16027480|NCT02685059|Drug|nab-Paclitaxel|nab-Paclitaxel 125 mg/m² weekly for 12 weeks
16027481|NCT02685059|Drug|Epirubicin|Epirubicin 90 mg/m² 2-weekly for 8 weeks
16027482|NCT02685059|Drug|Cyclophosphamide|Cyclophosphamide 600 mg/m² 2-weekly for 8 weeks
16027483|NCT02685046|Drug|Imatinib|Subjects will be treated with the medicinal product imatinib, which will be administered orally in tablets of 400mg, once per day, during two weeks prior to tumor resection.
16027484|NCT02685033|Drug|Dalbavancin|
16027485|NCT02685033|Drug|Comparator|
16027486|NCT02685020|Biological|Ad26.Mos.HIV|Recombinant replication-deficient Ad26 vectored vaccine and consists of 3 Ad26 vectors, one containing a mosaic insert of envelope (Env) sequence, and 2 vectors containing mosaic inserts of Gag and Pol sequences (Ad26.Mos.1.Env + Ad26.Mos1.Gag-Pol + Ad26.Mos2.Gag-Pol). Total dose is 5*10^10 viral particle per 0.5 milliliter (mL) injection administered intramuscularly.
16027487|NCT02685020|Biological|Clade C gp140|The Clade C gp140 vaccine containing 250 mcg of total protein, mixed with aluminum phosphate adjuvant, per 0.5 mL injection administered intramuscularly.
16027488|NCT02685020|Drug|Placebo|Normal saline, 0.5 mL injection administered intramuscularly.
16027489|NCT02685007|Other|Tachosil|TachoSil is a collagen matrix that is coated with human fibrinogen and human thrombin.
16027490|NCT02684994|Behavioral|Cognitive Processing Therapy|Cognitive-processing therapy is a well-supported treatment for reactions following traumatic events. It includes 12 individual psychotherapy sessions and consists of 4 components: education about trauma responses, experiencing emotions related to the assault, development of skills for examining the truth of thoughts, and examination of beliefs in areas commonly influenced by the trauma.
16027491|NCT02684968|Procedure|Colorectal surgery|
16027492|NCT02684955|Device|Cerebral spectroscopy|Cerebral spectroscopy (near-infrared spectroscopy - NIRS) allows to measure with a noninvasive method the local oxygen saturation of the prefrontal cortex (rSO2), reflecting the balance between need and supply of brain oxygenation.
16027493|NCT02684955|Device|Pupillometry|The quantitative measurement of the pupillary light reaction has been described to predict neurological outcome
16027494|NCT02684942|Drug|Meperidine|Injection meperidine 1 mg/kg with diazepam 0.1 mg/kg.to intravenous 5 minutes before inserting the applicator and then when the patients had pain score greater or equal to 4. All patients received supplement oxygen cannula 3 LPM continuously monitored for saturation, pulse and monitored every 5 minutes for blood pressure.
16027495|NCT02684942|Drug|Fentanyl|Injection meperidine 1 mg/kg to intravenous 5 minute before insertion the applicator and then when the patients had pain score greater than or equal to 4. All patients received supplement oxygen cannula 3 LPM continuously monitored for saturation, pulse and monitored every 5 minutes for blood pressure.
16027496|NCT02684929|Dietary Supplement|branched chain amino acids|15 (women) or 20 (men) grams of BCAA daily for 3 months
16027497|NCT02684916|Procedure|Chiropractic treatment|"The child receives chiropractic manipulation treatment in the neck and in the spine and pelvis according to individual needs. They also receive a written list of general advice regarding lifestyle and habits.
~The parents and the child are unaware of group allocation."
16027498|NCT02684916|Procedure|Placebo|Non-therapeutic placebo treatment: a broad non-specific contact outside the spinal column is taken on subject's scapula and gluteal region lying in a side posture position, on the scapulae in a prone position and on trapezius muscles in a sitting position. In those positions the chiropractor pushes in a non-intentional and non- therapeutic directional line with a low-amplitude, low velocity push maneuver. All contacts are performed without soft tissue pre-tension and gentle contact, to insure that no joint cavitation occurs. To obtain a noise that many people associate with a chiropractic spinal adjustment, a de-activated Activator Instrument is used on the arm of the chiropractor to give a click-sound. General advice on lifestyle and habits is handed out to the placebo group as well.
16027499|NCT02684903|Behavioral|Parent Child Interaction Therapy|PCIT is a 16-20 session live-coaching parenting intervention. PCIT for Child Welfare families is delivered in two sequential treatment phases following a motivational enhancement training: Phase 1, Child-Directed Interaction (CDI) to enhance positive parenting and interrupt harsh aversive parenting, and Phase 2, Parent-Directed Interaction (PDI) to coach effective parent commands and a consistent time-out protocol when child disobeys.
16027500|NCT02684877|Other|Questionnaire|
16027501|NCT02684864|Other|Non-interventional|
16027502|NCT02684851|Drug|Tranexamic Acid|Tranexamic acid: anti-fibrinolytic agents
16027503|NCT02684851|Drug|Placebo|Placebo
16027504|NCT02684825|Device|Reveal LINQTM- LNQ11 Internal Loop Recorder plus standard cardiac monitoring|Reveal LINQTM- LNQ11 continuously monitors cardiac electric activity for up to three years.
16027505|NCT02684812|Drug|Tranexamic Acid|Treatment until aneurysm treatment or maximum dosage of 4 gram
16027506|NCT02684799|Drug|Cenicriviroc|
16027507|NCT02684799|Drug|Omeprazole|
16027508|NCT02684799|Drug|Famotidine|
16027509|NCT02684786|Drug|reserpine|Patients with qualifying hemodynamics from prior right heart catheterization will receive open label reserpine, 0.05 mg by mouth daily for two weeks, then 0.10 mg by mouth daily for two weeks, and then have repeat non-invasive assessments of status
16027510|NCT02684786|Procedure|stellate ganglion block|Patients with suspected group 2 pulmonary hypertension by clinical and non-invasive assessments and are scheduled to undergo clinically indicated right heart catheterization will have pulmonary artery pressures measured. If qualifying severity of group 2 pulmonary hypertension is present, after clinically indicated assessment of inhaled nitric oxide, their baseline hemodynamics will be allowed to re-equilibrate over 10 minutes, and then ultrasound guided left stellate ganglion block with lidocaine will be performed, and hemodynamics reassessed 10 minutes afterward
16028478|NCT02677571|Drug|Levobupivacaine 0.25%|
16027511|NCT02684786|Drug|lidocaine|Patients with suspected group 2 pulmonary hypertension by clinical and non-invasive assessments and are scheduled to undergo clinically indicated right heart catheterization will have pulmonary artery pressures measured. If qualifying severity of group 2 pulmonary hypertension is present, after clinically indicated assessment of inhaled nitric oxide, their baseline hemodynamics will be allowed to re-equilibrate over 10 minutes, and then ultrasound guided left stellate ganglion block with lidocaine will be performed, and hemodynamics reassessed 10 minutes afterward
16027512|NCT02684773|Procedure|Conventional Hemodialysis|The intervention involves 3 hemodialysis sessions/week that consists of 4 hours/session
16027513|NCT02684773|Procedure|In-centre Nocturnal Hemodialysis|The intervention involves 3 hemodialysis sessions/week administered overnight (8 hours/session) in-hospital
16027514|NCT02684760|Drug|PF-06651600|PF-06651600 will be administered as a tablet and extemporaneously prepared solution in each cohort.
16027515|NCT02684747|Other|Autologous Transfusion|Participants will receive autologous transfusion on Day 21
16027516|NCT02684747|Other|Control - Normal Saline (Placebo)|Participants will receive saline on Day 21
16027517|NCT02684721|Other|8-week home-based exercise programme|8-week home-based exercise programme is assigned to patients in exercise group following discharge. This includes 3 follow-up telephone calls by physiotherapist.
16027518|NCT02684708|Drug|cyclophosphamide, vincristine, prednisone, dacarbazine|28-day chemotherapy cycle
16027519|NCT02684708|Drug|cyclo, vcr, pred, dacarb,etop and doxo|21-day chemotherapy cycle
16027520|NCT02684695|Other|MRI scan (adolescent spine protocol)|MRI scan of the lumbar spine and sacroiliac joints
16027521|NCT02684695|Other|MRI scan (whole body protocol)|MRI scan of multiple joints ('whole body')
16027522|NCT02684682|Behavioral|Frequency of mechanical control of plaque (12h)|Performing oral hygiene 12 in 12 hours, with tooth brush and interdental device.
16027523|NCT02684682|Behavioral|Frequency of mechanical control of plaque (24h)|Performing oral hygiene 24 in 24 hours, , with tooth brush and interdental device.
16027524|NCT02684682|Behavioral|Frequency of mechanical control of plaque (48h)|Performing oral hygiene 48 in 48 hours, , with tooth brush and interdental device.
16027525|NCT02684669|Drug|Naloxone|active drug infusion
16027526|NCT02684669|Drug|Normal saline|placebo comparator
16027527|NCT02684656|Procedure|Hemodialysis|Hemodialysis >/=4h
16027528|NCT02684656|Procedure|Hemodiafiltration|Hemodiafiltration >/=4h, > 20l convection
16027529|NCT02684643|Other|enhanced individualised therapy|additional dialysis dosage, modification of medication and prescribed dietary plan
16027530|NCT02684643|Other|non-enhanced individualised therapy|modified medication, prescribed dietary plan and regular three times/week dialysis dosage
16027531|NCT02684643|Other|regular intervention|Phosphate binders and calcitriol would be prescribed according to the guidelines. Phosphate binders included in the study are calcium acetate, calcium carbonate or sevelamer. Dosage is based on patients serum phosphate and calcium level. Calcitriol prescribed in the study is Rocaltrol and the dosage is based on PTH, serum phosphate and calcium level. Patients' diet habit will not be altered.
16027532|NCT02684630|Device|Trima Accel System|Platelet Apheresis Procedure
16027533|NCT02684617|Biological|pembrolizumab|200 mg administered as an intravenous (IV) infusion on Day 1 of infusion Cycles 1-35. Each cycle is 21 days.
16027534|NCT02684617|Drug|dinaciclib|dinaciclib 7 mg/m^2 administered as an IV infusion on Day 1 of infusion Cycle 1, dinaciclib 10 mg/m^2 administered as an IV infusion on Day 8 of infusion Cycle 1, dinaciclib 14 mg/m^2 administered as an IV infusion on Days 1 and 8 of infusion Cycles 2-35. Each cycle is 21 days.
16027535|NCT02684591|Drug|Aramchol|Aramchol, a conjugate of Cholic acid and Arachidic acid, is a first in class member of a novel family of synthetic Fatty-Acid / Bile-Acid Conjugates (FABACs). FABACs are composed of endogenic compounds, orally administrated with potentially good safety and tolerability parameters
16027536|NCT02684591|Drug|Placebo|Placebo
16027537|NCT02684578|Drug|Metformin|
16027538|NCT02684565|Dietary Supplement|BCAA High Protein supplement|Subjects will be randomly assigned to take high BCAA or low-BCAA protein a day for 4 weeks, then switch to BCAA or low-BCAA protein for 4 weeks after a 2-week washout.
16027539|NCT02684565|Dietary Supplement|BCAA Low Protein supplement|Subjects will be randomly assigned to take high BCAA or low-BCAA protein a day for 4 weeks, then switch to BCAA or low-BCAA protein for 4 weeks after a 2-week washout.
16027540|NCT02684552|Device|Non invasive ventilation|Training on treadmill with Non invasive ventilation
16027541|NCT02684552|Device|Oxygen|Training on treadmill with oxygen
16027542|NCT02684539|Device|tilt table Erigo®|tilting table with onset of syncope
16027543|NCT02684526|Procedure|Eovist Contrast|Subjects will undergo an MRI (magnetic resonance imaging) scan using the Eovist contrast agent. This MRI scan takes approximately 45minutes to 1 hour to complete.
16027544|NCT02684526|Procedure|Non Eovist Contrast|Subjects will undergo an MRI (magnetic resonance imaging) scan using a contrast agent other than Eovist. This MRI scan takes approximately 45minutes to 1 hour to complete.
16027545|NCT02684513|Dietary Supplement|Oral Carbohydrate Beverage|The oral carbohydrate beverage will be consume in a 710 mL amount the evening prior to surgery and then a 355 mL amount the morning of surgery.
16027546|NCT02684513|Dietary Supplement|Rehydration beverage|The rehydration beverage group will be consume in a 710 mL amount the evening prior to surgery and then a 355 mL amount the morning of surgery.
16027547|NCT02684500|Device|Ultrasound|Study measurements of the diameter and doppler flow velocity of the superior mesenteric artery (SMA) for a aneurysmal subarachnoid hemorrhage using abdominal ultrasound.
16027548|NCT02684487|Drug|vitamin D3|Patients will be given 400,000 IU of vitamin D3 within 24 hours of severe sepsis onset followed by weekly doses of 25,000 IU until 90 days or death, whichever comes first.
16027549|NCT02684487|Drug|Placebo|Patients will be given placebo within 24 hours of severe sepsis onset followed by weekly doses of placebo until 90 days or death, whichever comes first.
16027550|NCT02684474|Biological|HBOC-201|Intravenous administration of a hemoglobin based oxygen carrier (HBOC) in patients with life-threatening anemia, for whom allogeneic blood transfusion is not an option.
16027551|NCT02684461|Drug|Pembrolizumab|"Receive Pembrolizumab 200 mg on day 1 every 21 days for four cycles.
~Receive nab-paclitaxel 100 mg/m2 on day 1 and day 8 every 21 days for four cycles."
16028479|NCT02677571|Drug|Morphine|
16027554|NCT02684422|Other|Intervention N/A. Observational study|There are no interventions to the subjects other than collection of an expectorated sputum since this is an observational study; There are no study groups.See details per detailed study description.
16027555|NCT02684409|Drug|PROT-CL-NP101-015.01|
16027556|NCT02684396|Drug|TAK-648|TAK-648 Solution
16027557|NCT02684396|Drug|TAK-648 Placebo|TAK-648 placebo-matching solution
16027558|NCT02684383|Biological|rDEN3∆30|10^3 plaque-forming units (PFUs); administered by subcutaneous injection in the deltoid region of the upper arm
16027559|NCT02684383|Biological|Placebo|Administered by subcutaneous injection in the deltoid region of the upper arm
16027560|NCT02684370|Drug|risankizumab|Risankizumab administered by subcutaneous (SC) injection
16027561|NCT02684370|Drug|placebo for risankizumab|Placebo for risankizumab administered by subcutaneous (SC) injection
16027562|NCT02684370|Drug|ustekinumab|Ustekinumab administered by subcutaneous (SC) injection
16027563|NCT02684370|Drug|placebo for ustekinumab|Placebo for ustekinumab administered by subcutaneous (SC) injection
16027564|NCT02684357|Drug|risankizumab|Risankizumab pre-filled syringe, administered by subcutaneous (SC) injection
16027565|NCT02684357|Drug|ustekinumab|Ustekinumab pre-filled syringe, administered by subcutaneous (SC) injection
16027566|NCT02684357|Drug|placebo for risankizumab|Placebo for risankizumab pre-filled syringe, administered by subcutaneous (SC) injection
16027567|NCT02684357|Drug|placebo for ustekinumab|Placebo for ustekinumab pre-filled syringe, administered by subcutaneous (SC) injection
16027568|NCT02684344|Drug|Tamsulosin|Tamsulosin may have prophylactic properties against post-operative urinary retention
16027569|NCT02684344|Other|Education|Education about signs and symptoms of urinary retention
16027570|NCT02684331|Other|Cardiac Magnetic Resonance Imaging (CMR)|An extensive explorative CMR protocol, including time/volume curves of LV and LA, rest and stress perfusion (with Adenosin) and time/volume curve of LA after chronotropic stress with Glycopyrrolate, further flow measurements and T1 mapping.
16027571|NCT02684331|Other|Echocardiography|Standard measurements and strain.
16027572|NCT02684331|Other|Bood samples|HbA1c, Glucose, Hgb, Creatinin, Sodium, Potassium, Total cholesterol, LDL cholesterol, HDL cholesterol, Free fatty acids, ALAT, Urinary albumin, NT-proBNP, ANP, suPAR, Copeptin, Proendothelin, proCNP, Soluble ST2, Galectin-3
16027573|NCT02684318|Drug|PM01183 + olaparib|
16027574|NCT02684305|Drug|Administration of Propess|"History taking and physical examination including cervical length
~Eligibility assessment
~Explanation regarding the study protocol
~Signed informed consent (at VAS<3)
~Women agreeing to continued induction of labor 24 hours after insertion of Propess, will be randomized using sealed envelopes to the subsequent method of induction of labor (additional vaginal insert vs. oxytocin infusion with intracervical balloon insertion with 60ml saline). Treatment will be given according to the pre-existing and approved departmental protocol. The protocol for oxytocin infusion is 4 units of Pitocin in 10 cc 0.9% NaCl, infused at a rate of 0.4 ml/hour. Infusion rate will be increased every 20 minutes until 3-4 contractions every 10 minutes are produced.
~Follow up on all women will be performed from the time of second agent induction until discharge from hospital postpartum."
16027575|NCT02684305|Device|balloon|"History taking and physical examination including cervical length
~Eligibility assessment
~Explanation regarding the study protocol
~Signed informed consent (at VAS<3)
~Women agreeing to continued induction of labor 24 hours after insertion of Propess, will be randomized using sealed envelopes to the subsequent method of induction of labor (additional vaginal insert vs. oxytocin infusion with intracervical balloon insertion with 60ml saline). Treatment will be given according to the pre-existing and approved departmental protocol. The protocol for oxytocin infusion is 4 units of Pitocin in 10 cc 0.9% NaCl, infused at a rate of 0.4 ml/hour. Infusion rate will be increased every 20 minutes until 3-4 contractions every 10 minutes are produced.
~Follow up on all women will be performed from the time of second agent induction until discharge from hospital postpartum."
16027576|NCT02684305|Drug|Intravenous oxytocin infusion|"History taking and physical examination including cervical length
~Eligibility assessment
~Explanation regarding the study protocol
~Signed informed consent (at VAS<3)
~Women agreeing to continued induction of labor 24 hours after insertion of Propess, will be randomized using sealed envelopes to the subsequent method of induction of labor (additional vaginal insert vs. oxytocin infusion with intracervical balloon insertion with 60ml saline). Treatment will be given according to the pre-existing and approved departmental protocol. The protocol for oxytocin infusion is 4 units of Pitocin in 10 cc 0.9% NaCl, infused at a rate of 0.4 ml/hour. Infusion rate will be increased every 20 minutes until 3-4 contractions every 10 minutes are produced.
~Follow up on all women will be performed from the time of second agent induction until discharge from hospital postpartum."
16027577|NCT02684292|Biological|pembrolizumab|IV infusion
16027578|NCT02684292|Biological|brentuximab vedotin|IV infusion
16027579|NCT02684279|Drug|Dasotraline|Dasotraline 4, 6, 8 mg flexibly dosed once daily
16027580|NCT02684266|Drug|SHR6390|SHR6390 either 25, 50mg, 75mg, 100mg, 125mg, 150mg, 175mg given orally, QD
16027581|NCT02684253|Drug|Nivolumab|
16027582|NCT02684253|Radiation|Stereotactic Body Radiation Therapy (SBRT)|
16027583|NCT02684240|Drug|Nitazoxanide|nitazoxanide 1000 mg orally twice daily with food for 14 days
16027584|NCT02684240|Other|Control|The control arm will receive WHO standard therapy for tuberculosis with isoniazid, rifampin, pyrazinamide, and ethambutol
16027585|NCT02684227|Drug|Carboplatin|Given IV
16027586|NCT02684227|Drug|Enzalutamide|Given PO
16027587|NCT02684227|Other|Laboratory Biomarker Analysis|Correlative studies
16027588|NCT02684227|Drug|Paclitaxel|Given IV
16027589|NCT02684227|Other|Pharmacological Study|Correlative studies
16027632|NCT02683902|Behavioral|Hypocaloric diet|A hypocaloric dietary prescription and individual counseling from a dietician in order to reduce 3% of their initial weight over 4-week treatment.
16027633|NCT02683902|Device|Sham tDCS|The electrodes will be placed at the same positions as in active stimulation; however, the device will be turned off after 30 s of stimulation.
16027634|NCT02683889|Drug|Acthar|patients will receive acthar 80 units twice a week for 6 months and will measure recurrence of FSGS
16027635|NCT02683863|Drug|BG00012 (DMF) (Tecfidera®.)|Subjects will take DMF 120 mg BID for the first 4 weeks of treatment followed by DMF 240 mg BID for 24 weeks.
16028484|NCT02677532|Drug|Paracetamol|1 g every 8 hours
16027590|NCT02684214|Behavioral|Prevention Plus +|Families will receive 6 monthly newsletters and meet with a BHC at the clinic for 30 minutes during months 1, 3, and 5. Child height and weight will be taken. Families will receive feedback about growth and the weight status of their child. The session materials will be reviewed and behavioral parenting strategies will be encouraged to aid with changing two dietary and two leisure-time activity (energy balance) behaviors of the child. The caretaker will also change the same energy balance behaviors as the child, as adult caretakers can then model healthy behaviors. The caretaker and child will be encouraged to change and self-monitor energy balance behaviors with the use of the picture-based diaries. During months 2, 4, and 6, BHCs will complete a 20-minute phone call with the caretaker. Caretakers will be asked to measure the height and weight of their child, calculate BMI and plot it on the BMI-for-age growth chart prior to the call. The BHC will provide feedback.
16027591|NCT02684214|Behavioral|Prevention Plus -|This condition will be identical to PP+ except that caretakers will not receive any energy balance behavior goals. Additionally, the caretaker will not self-monitor energy balance behaviors. The focus will be on all other behavioral parenting strategies to assist the child with making changes in the targeted behaviors.
16027592|NCT02684201|Device|Boston Scientific Stimulator Lead|A Boston Scientific PMA P030017 spinal cord stimulator lead will be placed in the cervical epidural space of ten upper-limb amputees and steered laterally towards the dorsal spinal roots under fluoroscopic guidance.
16027593|NCT02684188|Behavioral|Enhanced rural discharge and transition|While in the treating hospital, patients from small towns and rural communities are engaged in package of procedures designed to improve the transitions home, including a functional needs assessment that produces a plan that matches available rural community service providers to a patient's transitions needs and the provision of enhanced recovery supports to the patient.
16027594|NCT02684175|Device|Remote CI Counseling|The remote setup includes a 500 series teleconference audio and video live set-up. The teleconference set-up will be situated on a telemedicine cart and placed within the sound-proof booth at the testing site (UK ENT practice in Morehead, KY). The audiologist will deliver the session remotely.
16027595|NCT02684175|Other|In-Person CI Counseling|The standard face-to-face counseling that will occur between the participant and audiologist is the standard of care. No technology will be used. The audiologist will deliver the session face-to-face with the participant in the same room (standard practice).
16027596|NCT02684162|Biological|Donor Lymphocytes|Given IV
16027597|NCT02684162|Drug|Guadecitabine|Given SC
16027598|NCT02684162|Other|Laboratory Biomarker Analysis|Correlative studies
16027599|NCT02684149|Procedure|relational touch|
16027600|NCT02684136|Drug|suvorexant|suvorexant 20 mg taken before sleep
16027601|NCT02684136|Drug|placebo|placebo taken before sleep
16027602|NCT02684123|Drug|Apremilast|Subjects will get drug or placebo
16027603|NCT02684123|Drug|Placebo|
16027604|NCT02684097|Drug|Tralokinumab|All groups will receive study drug every two weeks for 24 weeks.
16027605|NCT02684097|Drug|Placebo|Matching placebo given every two weeks for 24 weeks
16027606|NCT02684084|Drug|Ozurdex|OZURDEX® (DEX implant; Allergan Inc. Irvine, CA, USA) is a sustained-release biodegradable implant approved for treatment of Macular Edema secondary to central retinal vein occlusion as well as noninfectious uveitis affecting the posterior segment
16027607|NCT02684084|Drug|Lucentis|LUCENTIS® (0.5 mg ranibizumab or RBZ, an anti-neovascular VEGF-A inhibitor, Novartis Pharmaceuticals Canada Inc.) was the first approved medical treatment for DME
16027608|NCT02684071|Drug|Intra thecal methotrexate|IT methotrexate via Ommaya reservoir with concomitant systemic topotecan and cyclophosphamide
16027609|NCT02684071|Drug|topotecan|To be administered in conjunction with methotrexate
16027610|NCT02684071|Drug|cyclophosphamide|To be administered in conjunction with methotrexate and topotecan
16027611|NCT02684058|Drug|dabrafenib|dabrafenib oral, twice daily.
16027612|NCT02684058|Drug|trametinib|trametinib oral, once daily.
16027613|NCT02684058|Drug|Carboplatin with vincristine|Chemotherapy of carboplatin with vincristine - LGG only
16027614|NCT02684032|Drug|Gedatolisib|Gedatolisib weekly intravenous starting at 180 mg/week in a 4 week cycle.
16027615|NCT02684032|Drug|Palbociclib|Palbociclib initiated at 125 mg daily: 3 out of 4 weeks in a 4 week cycle.
16027616|NCT02684032|Drug|Letrozole|Letrozole at 2.5 mg daily
16027617|NCT02684032|Drug|Fulvestrant|Fulvestrant administered intramuscularly at 500 mg on Day 1, 15 and 28 and then every 28 days.
16027618|NCT02684019|Drug|Dexmedetomidine|added to propofol sedation
16027619|NCT02684019|Drug|Magnesium Sulphate|added to propofol sedation
16027620|NCT02684006|Drug|Avelumab (MSB0010718C)|IV treatment Avelumab administered at 10 mg/kg IV every two weeks
16027621|NCT02684006|Drug|Axitinib (AG-013736)|Oral treatment Axitinib given 5 mg PO BID
16027622|NCT02684006|Drug|Sunitinib|Oral treatment Sunitinib given at 50 mg PO QD on schedule 4/2
16027623|NCT02683993|Device|Lumenis Pulse 120H holmium laser system and 200 DFL ball tip fiber|The Lumenis Pulse P120H will be utilized in high and low frequencies according to subjects group allocation.
16027624|NCT02683980|Device|Lumenis Pulse P120H and Xpeeda side firing fiber|
16027625|NCT02683967|Procedure|acupuncture|patients received a Delphi acupuncture at least 3 times during their fertility treatment cycle.
16027628|NCT02683928|Biological|GBR 830|
16027629|NCT02683928|Biological|Placebo|
16027630|NCT02683915|Procedure|Therapeutic hypothermia|Infants in cooled group will be fitted a cooling cap (Olympic Medical Cool Care System, Olympic Medical) around the head for 72 h. infants will be nursed under a radiant overhead heater, which is servo-controlled to the infant's abdominal skin temperature and adjusted to maintain the rectal temperature at 33.5-34.5ºC. At the end of the 72 h cooling period, the infants will be slowly rewarmed at no more than 0•5ºC /h until their temperature become within normal temperature range (36.5-37.5ºC).
16027631|NCT02683902|Device|Active tDCS|The anode electrode will be placed over F4 position and the cathode electrode over F3, right and left respectively (using EEG 10/20 system). The electric current will be ramped up until it reaches 2 milliampere (mA), and subjects will be stimulated for 20 min.
16027636|NCT02683850|Dietary Supplement|Omega-3 SPM™ softgel|This four week, prospective, non-randomized, open-label study is assessing the impact on quality of life from taking an Omega-3 SPM™ softgel supplement in adults with pain symptoms at screening of 4 or higher on the PROMIS-43 Profile - Pain Intensity subscale.
16027637|NCT02683837|Drug|Remifentanil|
16027638|NCT02683837|Device|Pupillometry|Pupillary diameter measured every 5 minutes
16027639|NCT02683837|Drug|Sevoflurane|Administered to maintain a Bispectral Index between 40 and 60
16027640|NCT02683824|Diagnostic Test|Computed Tomography|Undergo CT scan
16027641|NCT02683824|Other|Laboratory Biomarker Analysis|Correlative studies
16027642|NCT02683824|Diagnostic Test|PET/MRI scan|Undergo PET/MRI scan
16027643|NCT02683824|Drug|[18F]FP-R01-MG-F2|radioactive tracer
16027644|NCT02683811|Behavioral|Diario della Salute (DDS-2)|The updated version of Diario della Salute program (DDS-2) includes: 1) teachers' manual, 2) a booklet for teens telling the story of four same-age students (e.g. experimenting with risky behaviours, conflicting feelings and thoughts, need for independence and control, etc.), 3) a booklet for parents telling the experience of a mum and a dad with teenage children (e.g. problems in the relationship with teenage children, family conflicts, parental control and supervision, family communication, etc.).
16027645|NCT02683798|Dietary Supplement|Continuous energy restriction|1 x formula food (202-209kcal) meal replacement per day
16027646|NCT02683798|Dietary Supplement|Intermittent energy restriction|4 x formula food (202-209kcal) total diet replacement per day, on 2 days per week
16027647|NCT02683785|Drug|GSK3196165|GSK3196165 will be supplied as a liquid and will be administered as a subcutaneous injection. The drug will be administered weekly for 5 injections, then every other week for 3 further injections.
16027648|NCT02683785|Drug|Placebo|Matching placebo will be administered as above.
16027649|NCT02683772|Device|Astral|Astral ventilator
16027650|NCT02683759|Dietary Supplement|Bio-enhanced Curcumin Soft Gelatin Capsule|"Each capsule is a bio-enhanced modification of curcumin (diferuloylmethane), which is a derivative of curcuma longa (rhizome extract)
~Starting dose: 50 mg BID of Bioenhanced Curcumin Increase dose to 100 mg BID after two (2) weeks if there is no response to the drug"
16027651|NCT02683759|Drug|5-Aminosalicyclic acid|Dosage is as instructed by patient's physician
16027652|NCT02683746|Drug|Lyophilized albiglutide DCC pen injector|A fixed-dose, fully disposable pen injector system with a prefilled dual chamber glass cartridge (DCC) containing lyophilized albiglutide (30mg or 50mg) delivering an injection volume of 0.5mL.
16027653|NCT02683746|Drug|Lyophilized albiglutide DCC pen injector matching placebo|A fixed-dose, fully disposable pen injector system with a prefilled DCC containing matching placebo delivering an injection volume of 0.5mL
16027654|NCT02683746|Drug|Albiglutide liquid auto-injector|A fixed-dose, single use, disposable auto-injector containing albiglutide liquid (30mg or 50mg) in a prefilled glass syringe. The auto-injector delivers the albiglutide liquid in an injection volume of 0.6 mL for the 30mg dose and 1.0 mL for the 50mg dose.
16027655|NCT02683746|Drug|Albiglutide liquid auto-injector matching placebo|A fixed-dose, single use, disposable auto-injector containing matching placebo in a prefilled glass syringe. The auto-injector delivers the matching placebo in an injection volume of 0.6 mL for the 30mg dose and 1.0 mL for the 50mg dose.
16027656|NCT02683733|Dietary Supplement|Bio-enhanced Curcumin Soft Gelatin Capsule|Each capsule is a bio-enhanced modification of curcumin (diferuloylmethane), which is a derivative of curcuma longa (rhizome extract)
16027657|NCT02683733|Drug|5-Aminosalicylic acid|Dosage is as instructed by patient's physician
16027658|NCT02683720|Dietary Supplement|ONS|randomized clinical trial involving different ONS strategies
16027659|NCT02683707|Other|Removal of Fentanyl from peri-procedural analgesia|Removal of Fentanyl from peri-procedural analgesia (which is otherwise routinely given for PCI)
16027660|NCT02683707|Drug|Fentanyl|IV peri-procedural analgesia
16027661|NCT02683707|Drug|Lidocaine|Local Anesthetic
16027662|NCT02683707|Drug|Midazolam|IV sedation
16027663|NCT02683694|Device|iOCT|the number of subjects that can be peeled without dye are assessed
16027664|NCT02683668|Combination Product|Handihaler-Tiotropium 18 mcg untrained|We are looking at the untrained used of Handihaler
16027665|NCT02683668|Combination Product|Handihaler-Tiotropium 18 mcg trained|We are looking at the trained use of Handihaler after 14 days treatment
16027666|NCT02683668|Combination Product|Respimat-Tiotropium 5 mcg trained|we are looking at the trained use of Respimat after 14 days treatment
16027667|NCT02683655|Drug|Apatinib|Apatinib 500mg qd p.o.
16027668|NCT02683655|Drug|Apatinib|Apatinib 750mg qd p.o.
16027669|NCT02683629|Biological|NTCELL Implantation|NTCELL Implantation
16027670|NCT02683629|Other|Sham Surgery|Sham Surgery
16027671|NCT02683616|Device|CPAP|Continuous Positive Airway Pressure in cases of moderate/severe OSA
16027672|NCT02683603|Drug|"AS colistin and imipenem"|colimycin (colistin) powder (1 million units (MU) by flakon) by AS route in addition to imipenem
16027673|NCT02683603|Drug|"IV colistin  and imipenem ."|colimycin (colistin) powder (1 MU by flakon) by intravenous route in addition to imipenem
16027674|NCT02683603|Drug|AS colimycin (colistin)|nebulisation of colimycin (colistin) for 30 minutes 3 times per day during at least 14 days. Nebulisation was made via an ultrasonic vibrating plates nebulizer (Aeroneb Pro® Aerogen Nektar Corporation, Galway, Ireland).
16027675|NCT02683603|Drug|IV colimycin (colistin)|intravenous colimycin (colistin) : 9 MU during 60 minutes followed by 4.5 million units 2 times per day
16027676|NCT02683603|Drug|AS colistin and imipenem|IV imipenem 1 g three times per day.
16027677|NCT02683603|Drug|IV colistin and imipenem|IV imipenem 1 g three times per day
16027678|NCT02683590|Device|Ceramic Implant|The replacement of the sternum by a ceramic implant
16027679|NCT02683577|Drug|telotristat etiprate|
16027680|NCT02683564|Drug|BOW015|monoclonal antibody against TNF-alpha
16027681|NCT02683564|Drug|Remicade|monoclonal antibody against TNF-alpha
16027682|NCT02683551|Procedure|Sutureless Thyroidectomy|Thyroidectomy performed with energy based devices and no use of ligation. Used device is not altered for this study. Non of the personnel in the operating room including surgical team knows if the patient was enrolled or not in this study.
16028528|NCT02677272|Other|Appropriateness of NH resident's transfer to ED|
16027683|NCT02683538|Device|Separable cluster electrode (Octopus®)|Patients undergo RFA under ultrasound guidance, and separable cluster electrodes are used for RFA in monopolar switching mode, using multiple overlapping technique to create larger ablative zones.
16027684|NCT02683525|Drug|Sitagliptin|600 mg ever 12 hours by mouth will be given starting the day before transplant through day +14 after transplant
16027685|NCT02683512|Other|No intervention|This is an observational study that consists of data abstraction.
16027686|NCT02683499|Procedure|Ultrasonic tips|These tips are going to be used to give the final shape of the prepared surfaces before taking the impression for the construction of the veneers.
16027687|NCT02683486|Device|Intelligent oxygen therapy (an auto-titrating oxygen system)|This device is an auto-titrating oxygen system. The system is programmed to maintain a specific target SpO2 by automatically adjusting the oxygen flow rate. The system can deliver flow rates of 0-5 litres/minute.
16027688|NCT02683486|Device|Long-term oxygen therapy|This is the patients usual long-term oxygen therapy
16027689|NCT02683460|Procedure|Patella resurfacing|
16027690|NCT02683460|Procedure|Patella retention|
16027691|NCT02683447|Other|CRM Simulation|Each participant will manage a PEA arrest scenario (pre-test) and then be debriefed on their CRM skills by a trained facilitator for 20 minutes. They will then manage another crisis scenario (PEA arrest with a different inciting event) as an immediate post-test. Three months afterwards participants will return to manage a third PEA arrest scenario, which will serve as a retention post-test.
16027692|NCT02683434|Device|Kinesio Taping application|Therapeutic taping application applied to skin affecting muscle, fascia, circulation, ligaments, tendons and joints.
16027693|NCT02683421|Drug|Tilmanocept|
16027694|NCT02683408|Other|placebo|inactive placebo
16027695|NCT02683408|Dietary Supplement|diosmiplex|diosmiplex is an FDA regulated medical food product
16027696|NCT02683395|Drug|PLX51107|
16027697|NCT02683382|Device|Moisturizing Eye Product in Liquid Formula|Moisturizing Eye Product in Liquid Formula for dry eyes and skin around the eyes
16027698|NCT02683369|Dietary Supplement|Blood Builder®/Iron Response®|"The low-dose iron dietary supplement is a tablet that contains vitamins and minerals selected to help maintain healthy red blood cells and iron levels in the blood. The supplement ingredients aim to generate a supplement by taking a food which contains the naturally occurring, complex matrix of proteins, lipids, carbohydrates and all other elements associated with the vitamin or mineral of interest. These natural food sources are used to generate tablets that maintain the vitamin and mineral potency found in the original food source as well as the associated elements that naturally accompany it.
~One tablet will be taken once a day offering a total daily serving of:
~15 mg of Vitamin C
~400 mcg of Folate
~30 mcg Vitamin of B-12
~26 mg of Iron
~125 mg of Beet Root"
16027699|NCT02683356|Other|OCT-guided PCI|Patients assigned to the OCT-guided PCI strategy will undergo OCT prior to PCI to determine vessel and lesion dimensions and treatment strategy. OCT will be repeated at the end of the procedure and corrective PCI will aim to optimize the PCI result according to pre-specified criteria in terms of minimal lumen area, scaffold expansion, apposition, residual dissections or intra-scaffold thrombus formation
16027700|NCT02683356|Other|Angiography-guided PCI|Patients assigned to the OCT-guided PCI strategy will only undergo OCT after PCI to determine vessel and lesion dimensions and treatment strategy.
16027701|NCT02683330|Behavioral|Mindfulness-based intervention (MBI)|MBI consists of 8 sessions and will cover becoming aware of emotions, thoughts and physical sensations, decentering and acceptance. Recordings of the body scan, a sitting meditation and a mindful movement meditation will be provided for daily home practice. Special care will be taken to address safety in the context of PD, and to adapt meditations to the physical limitations of PD.
16027702|NCT02683317|Dietary Supplement|docosahexaenoic acid|Docosahexaenoic acid is a dietary supplement derived from algae.
16027703|NCT02683317|Dietary Supplement|sunflower oil|Sunflower similar to the excipient used in experimental group
16027704|NCT02683304|Biological|Plasma S100B levels at inclusion|Patients will have blood drawn to measure plasma S100B levels at inclusion.
16027705|NCT02683304|Device|Magnetic resonance imaging|If not performed under emergency conditions, patients will have an MRI on days 2-4.
16027706|NCT02683291|Drug|sirolimus|
16027707|NCT02683291|Drug|tacrolimus|
16027708|NCT02683291|Drug|mycophenolate|
16027709|NCT02683291|Drug|Prednisone|Prednisone 30mg/day
16027710|NCT02683291|Drug|Basiliximab|Basiliximab 20mg (first and fourth day) if panel reactivity class I less than 50 %
16027711|NCT02683291|Drug|Thymoglobulin|Thymoglobulin at a dose of 1mg/kg for 5 days if panel reactivity class I greater than 50 %
16027712|NCT02683278|Behavioral|Cognitive-behavioral|Seven sessions of group-based treatment targeting skills to improve dysfunctional pain-related thoughts and behaviors
16027713|NCT02683278|Behavioral|Mindfulness-acceptance|Seven sessions of group-based treatment targeting skills to improve mindful awareness and acceptance of pain and stress, and increase positive emotional experiences
16027714|NCT02683278|Other|Pain Education|Seven sessions of group-based education to provide information regarding managing a chronic pain condition, but with no exercises to promote skill development
16027715|NCT02683265|Drug|Aptensio XR|Optimized dose of Aptensio XR (10, 15, 20, 30 or 40 mg) administered orally, once daily
16027716|NCT02683265|Drug|Placebo|Placebo capsules
16027717|NCT02683252|Other|T1 mapping and MR perfusion acquisition|One T1 mapping acquisition with variable flip angles will be performed before contrast injection. One perfusion 3D FSPGR sequence will be acquired after contrast injection
16027718|NCT02683239|Drug|Fasinumab|Participants will receive sub-cutaneous (SC) injections of fasinumab
16027719|NCT02683239|Drug|Placebo|Participants will receive sub-cutaneous (SC) injections of matching placebo
16027720|NCT02683226|Drug|Vipdomet|
16027721|NCT02683226|Drug|Incresync|
16027722|NCT02683213|Drug|Fluoxetine|Fluoxetine 20mg once daily for 6 months.
16027723|NCT02683213|Drug|Placebo|Matching placebo.
16027724|NCT02683200|Radiation|Image-Guided Adaptive Radiation Therapy|Undergo MRI-guided Tri-60Co teletherapy SBRT
16027725|NCT02683200|Radiation|Stereotactic Body Radiation Therapy|Undergo MRI-guided Tri-60Co teletherapy SBRT
16027794|NCT02682641|Drug|Rituximab|Rituximab 375 mg/m2 iv day 1,8, 15 and 22 (cycle 1, 4 doses). Rituximab 375 mg/m2 iv, day one of every other cycle for 4 doses (cycle 3, 5, 7 and 9).
16027726|NCT02683187|Drug|Active Comparator: Sitagliptin|Subjects will receive sitagliptin prior to the start of the experiment involving 1/2 of the subjects receiving Exendin-9 (a GLP-1 receptor blocker) first over 60 minutes ; followed by a bolus arginine (5g) infusion after 30 minutes into the Ex-9 infusion, with blood draws over the next 30 minutes. Followed by a 60 minute washout and the procedure is repeated , this time with saline instead of Ex-9 (these procedures are reversed - saline first then Ex-9 - half of the time).
16027727|NCT02683187|Drug|Placebo Comparator - No Sitagliptin|Subjects will receive Placebo (instead of sitagliptin) prior to the start of the experiment involving 1/2 of the subjects receiving Exendin-9 (a GLP-1 receptor blocker) first over 60 minutes ; followed by a bolus arginine (5g) infusion after 30 minutes into the Ex-9 infusion, with blood draws over the next 30 minutes. Followed by a 60 minute washout and the procedure is repeated , this time with saline instead of Ex-9 (these procedures are reversed - saline first then Ex-9 - half of the time).
16027728|NCT02683174|Device|Novel ambulatory patch (ZIO® XT Patch)|All enrolled patients will be fitted with a novel ambulatory patch (ZIO® XT Patch)
16027729|NCT02683174|Biological|BNP and hs-troponin I at 0 and 3 hours post ED attendance|All patients will have quantification of hs-troponin I (ARCHITECTSTAT high-sensitivity troponin I assay) and BNP (ALERE TRIAGE point-of-care BNP test; ALERE, San Diego, USA; www.alere.co.uk) at 0 and 3 hours post ED attendance.
16027730|NCT02683161|Drug|Varenicline|Varenicline will be administered as clinically indicated and will begin approximately 4-6 weeks prior to surgery. All participants will receive a 1-week dose induction period before transitioning to a full maintenance dose.
16027731|NCT02683161|Behavioral|Contingency Management|Contingency Management payments will begin on the target quit date (week 2) and will be in place for 5 weeks or until surgery (whichever is sooner). Participants will receive monetary incentives for biochemical evidence of smoking abstinence.
16027732|NCT02683161|Behavioral|Behavioral Counseling|All participants will complete a 3-session behavioral counseling intervention with a trained member of our study staff during 3 of the pre-surgical study visits. This brief counseling intervention provides participants with information about the experience of quitting smoking, including a benefits/disadvantage analysis, functional analysis of craving/risk periods, and skills-building exercises to prevent lapse and relapse.
16027733|NCT02683148|Drug|DHEA|
16027734|NCT02683148|Other|FACT-67 validated survey|"Baseline, Cycle 1 Day 15, and Day 1 of each cycle beginning with Cycle 2
~7 questions with answers ranging from 0=Not At All to 4 = Very Much."
16027735|NCT02683135|Behavioral|High-carbohydrate diet|Participants will engage in 4 days of high-carbohydrate low fat diet as recommended by the Canadian Diabetes Association. The macronutrients content will go as follow: 55% carbohydrate, 25% protein and 20% fat. Breakfast, lunch and dinner will be provided to the participants as part of an isoenergetic diet. Between interventions there will be at least a one-week washout, where participants are encouraged to return to their baseline dietary habits.
16027736|NCT02683135|Behavioral|Low-carbohydrate diet|Participants will engage in 4 days of low-carbohydrate high-fat diet. The macronutrients content will go as follow: 10% carbohydrate, 25% protein and 65% fat. Breakfast, lunch and dinner will be provided to the participants as part of an isoenergetic diet. Between interventions there will be at least a one-week washout, where participants are encouraged to return to their baseline dietary habits.
16027737|NCT02683135|Behavioral|Low-carbohydrate diet with post-meal walking|Participants will follow the same diet as in the low-carbohydrate diet arm but also perform 15 minutes of walking beginning ~15 minutes after breakfast, lunch and dinner. Approximately 70 kcal (individualized) will be added to main meals to account for exercise energy expenditure. Between interventions there will be at least a one-week washout, where participants are encouraged to return to their baseline dietary habits.
16027738|NCT02683109|Drug|FDC of tiotropium + olodaterol|Fixed Dose Combination of tiotropium + olodaterol
16027739|NCT02683109|Drug|Placebo|
16027740|NCT02683109|Drug|Tiotropium|
16027741|NCT02683109|Drug|Olodaterol|
16027742|NCT02683096|Other|Observation|Viable Infants with a failed hearing screen or a diagnosis of SGA who are born at either St. John's Hospital or MMC at ≥ 28 weeks gestation.
16027743|NCT02683083|Biological|[131I]-SGMIB Anti-HER2 VHH1|
16027744|NCT02683070|Procedure|Bilateral pudendal nerve block|Bilateral pudendal nerve block with 30ml of 0.33% ropivacaine (15ml for each side) after the completion of surgery before extubation
16027745|NCT02683070|Drug|Intravenous tramadol|Intravenous tramadol of 1.5mg/kg after the completion of surgery before extubation
16027746|NCT02683057|Other|International Physical Activity Questionnaire (IPAQ)|all candidates for sperm donors clinic IVI IVI Bilbao and Valencia were will provide the international physical activity questionnaire (IPAQ) attached to analyze the total physical activity. This will be self-completed questionnaire beforeSperm donation. (Appendix 1) Age, snuff, weight, BMI, alcohol, drug use and the type of sport that practices will be analyzed: Additionally a tab for each donor collecting the existence of associated factors be drawn. (Appendix 2)
16027747|NCT02683044|Procedure|Low-Intensity Extracorporeal Shock Wave Therapy (Li-ESWT)|Sessions of shocks to the body of the penis
16027748|NCT02683031|Other|Ca2+ ionophore|Ca2+ ionophore is a chemical agent used to perform oocyte activation after ICSI. It showed effective treatment to get better fertilization, pregnancy, and healthy livebirth in cases with total or partial fertilization failure.
16027749|NCT02683018|Drug|Smoked Cannabis High CBD/low THC|Participants will visit the Marijuana Research Laboratory 3-5 weekdays per week for 4 weeks to be administered 1-2 cannabis cigarettes (15.76% CBD; 3.11% THC) over the course of a 2-3 hour session.
16027750|NCT02683018|Drug|Smoked Placebo Cannabis Low CBD/low THC|Participants will visit the Marijuana Research Laboratory 3-5 weekdays per week for 4 weeks to be administered 1-2 cannabis cigarettes (0.01% THC; 0.00% CBD) over the course of a 2-3 hour session.
16027751|NCT02683005|Drug|ledipasvir/sofosbuvir|Hepatitis C treatment with ledipasvir and sofosbuvir will be initiated during pregnancy at approximately 24 weeks of gestation.
16027795|NCT02682628|Drug|Coppertone (BAY987517)|Each 50 cm*2 test site area of a subject requires 100 mg of a test material to obtain a standard 2 mg/cm*2 test application.
16027796|NCT02682602|Device|DePuy Synthes total hip arthroplasty|
16027797|NCT02682602|Radiation|Computer tomography|Computer tomography (CT) scan of the hip for creation of bone models.
16027828|NCT02682329|Other|Hydrogen Peroxide and Carbamide Peroxide|Carbamide Peroxide + Hydrogen Peroxide were administered to each patient on this group. HP 10% at home and HP 40% at office
16027752|NCT02682992|Device|Low Level Laser Therapy|Patients will receive LLLT three times per week concurrently with chemoradiotherapy. LLLT may be delivered either immediately prior to or after the patient's daily fraction of radiotherapy. Patients will be treated extra-orally with a THOR® LED cluster for one minute along the buccal mucosa on each side and intraorally for one minute to the tongue and soft palate. During each LLLT treatment session a thorough oral exam will be performed to identify any areas of mucositis. If the patient should develop intraoral lesions they will be targeted directly with the intraoral probe for one minute to each site of mucositis. The laser settings to be used are as follows: frequency 2.5 Hz; wavelength 660 nm; and power 75 mW, for an energy of 4.5 J.
16027753|NCT02682979|Other|Medical files analysis|Retrospective analysis of the medical files according to medical, social and geriatric criteria.
16027754|NCT02682966|Radiation|Coronary Computed Tomography Angiography|Coronary Computed Tomography Angiography will be performed in all participants
16027755|NCT02682953|Drug|Neupogen|Pharmacological agents often used for stem cell mobilization will be utilized in this study.
16027756|NCT02682953|Procedure|Hyperbaric oxygen therapy|Exposure to oxygen at 2.4 atmospheres absolute for 90 minutes/day for 3 to 5 days
16027757|NCT02682953|Drug|Plerixafor|Pharmacological agents often used for stem cell mobilization will be utilized in this study.
16027758|NCT02682940|Device|Vigilant Diabetes Management Application|Subjects will download the Vigilant Diabetes Management Application and use it in conjunction with a study supplied wireless blood glucose meter. They will check blood glucose values at least three times a day and receive summaries and notifications from Vigilant regarding periods of risk and blood glucose patterns.
16027759|NCT02682927|Drug|ZX008 (Fenfluramine Hydrochloride)|ZX008 drug product is an oral aqueous solution of fenfluramine hydrochloride buffered to pH 5. The product is sugar free and is intended to be compatible with a ketogenic diet.
16027760|NCT02682927|Drug|Matching Placebo|Placebo solution for ZX008. The product is sugar free and is intended to be compatible with a ketogenic diet.
16027761|NCT02682901|Drug|Cycloset|Cycloset 1.6 -3.2 mg/day
16027762|NCT02682901|Drug|Placebo|Non-active placebo for cycloset
16027763|NCT02682888|Behavioral|trait anxiety scale|splitting subjects into 2 groups according to scores of the trait anxiety scale
16027764|NCT02682888|Drug|Oxytocin|intranasal administration of oxytocin
16027765|NCT02682888|Drug|Placebo|intranasal administration of placebo
16027766|NCT02682862|Drug|olodaterol hydrochloride 2.5mcg, tiotropium bromide 2.5mcg|Inhaler: 2.5 microgram tiotropium (as bromide monohydrate) and 2.5 microgram olodaterol (as hydrochloride) per puff. 2 puffs once daily
16027767|NCT02682862|Drug|olodaterol 2.5 mcg|Inhaler: 2.5 microgram Olodaterol (as hydrochloride) per puff. 2 puffs once daily
16027768|NCT02682836|Behavioral|Walk with Ease|
16027769|NCT02682823|Device|AI-1000 G2|Tocilizumab will be administered using the AI-1000 G2.
16027770|NCT02682823|Drug|Tocilizumab|Participants will receive three doses of SC tocilizumab using the AI-1000 G2 device at Visits 1, 2, and 3 (Days 0, 14, and 28). The dose will remain at 162 milligrams (mg) unless changes are required per protocol for safety or efficacy reasons.
16027771|NCT02682810|Device|DNA PCR HIV diagnostic test|standard of care
16027772|NCT02682810|Device|Alere Q|POC diagnostic Alere Q qualitative test (along with a DBS drawn for confirmatory DNA PCR)
16027775|NCT02682771|Device|Bilevel positive airway pressure|The use of positive airway pressure airway seeking in the prevention or treatment of hypoxic respiratory failure, improved arterial oxygenation, restoration or maintenance of lung volume reduction and atelectasis, decrease the work of breathing, decreased dyspnea index and increased residual volume
16027776|NCT02682771|Device|PowerBreathe|Exercises with inspiratory load has the aim to trainning inspiratory muscle in strength and endurance, thus, could help to prevent postoperative complications.
16027777|NCT02682771|Procedure|Conventional Respiratory Physiotherapy (CRP)|CRP consisted of diaphragmatic respiratory exercises, deep inhalation exercises, inhalations fragmented two to three times and respiratory exercises associated with shoulder flexion movements and extension of the upper limbs. One series of 10 repetitions was carried out for each exercise. Walking sessions and preventive exercises for deep vein thrombosis were carried out
16027778|NCT02682758|Drug|Xenon|Wash-in of xenon for maintenance of anaesthesia
16027779|NCT02682745|Drug|HL151|Test drug l : HL151, 1T, single oral administration on an empty stomach, Test drug ll : HL151, 1T, single oral administration after meal
16027780|NCT02682745|Drug|TALION tab.|Reference drug: TALION tab, 1T, every 12 hours, oral administration
16027781|NCT02682732|Procedure|FDG-PET/CT guided bone marrow sampling|(Fluorodeoxyglucose positron-emission tomography) FDG-PET/CT guided bone marrow sampling will be used to obtain two different samples from avid and dim bone marrow areas.
16027782|NCT02682693|Drug|Denosumab|Denosumab 120 mg every 4 weeks for 6 cycles
16027783|NCT02682693|Drug|nab-Paclitaxel|nab-paclitaxel 125 mg/m² weekly for 12 weeks or at day 1,8 q22 for 4 cycles (12 weeks)
16027784|NCT02682693|Drug|Epirubicin|Epirubicin 90 mg/m² every 2 or 3 weeks for 4 times
16027785|NCT02682693|Drug|Cyclophosphamide|Cyclophosphamide 600 mg/m² every 2 or 3 weeks for 4 times
16027786|NCT02682693|Drug|Carboplatin|Carboplatin AUC 2 weekly in parallel to nab-Paclitaxel
16027787|NCT02682693|Drug|Trastuzumab|Trastuzumab 6 (8) mg/kg every 3 weeks simultaneously to all chemotherapy cycles
16027788|NCT02682693|Drug|Pertuzumab|Pertuzumab 420 (840) mg every 3 weeks simultaneously to all chemotherapy cycles
16027789|NCT02682680|Drug|Colesevelam|Colesevelam 3.75 g daily for 24 weeks
16027790|NCT02682680|Drug|Ezetimibe|Ezetimibe 10 mg daily for 24 weeks
16027791|NCT02682654|Device|Dr. Scholl's Prototype Ankle Brace|Subjects will be instructed to wear the assigned Ankle/Knee brace for 8 ± 2 hours per day, for a minimun of 5 days out of a 7-day/1 week wear period.
16027792|NCT02682654|Device|Dr. Scholl's Prototype Knee Brace|Subjects will be instructed to wear the assigned Ankle/Knee brace for 8 ± 2 hours per day, for a minimun of 5 days out of a 7-day/1 week wear period.
16027793|NCT02682641|Drug|IBRUTINIB|Ibrutinib 560 mg daily po for 28 days (cycle one). Continuous cycles until disease progression or unacceptable toxicity.
16027901|NCT02681757|Device|Mepitel Ag|used for variable/experimental group under soft cast
16027798|NCT02682602|Radiation|Fluoroscopy surveillance|Fluoroscopy evaluation of the hip during gait (level walking), chair rise, and ramp ascent and descent activities. Sound/vibration data will be collected simultaneously via non-invasive sensors attached to the hip joint.
16027799|NCT02682589|Procedure|Open surgery|A traditional midline incision is made through the abdominal wall and a colectomy with CME is performed.
16027800|NCT02682589|Procedure|Laparoscopic surgery|3-5 small incisions are made through the abdominal wall for the placement of trocars and the abdominal cavity is insufflated with carbon dioxide to allow access, visualization and operation. A 6-8cm auxiliary incision is made for specimen extraction and anastomosis. Conversion may occur due to technical difficulties or intraoperative complications, which is defined when completion of the dissection of the mesocolon is performed through a traditional open abdominal approach. Patients undergo conversion to laparotomy will be excluded from this study.
16027801|NCT02682576|Procedure|Brachial artery ultrasound imaging|
16027802|NCT02682563|Drug|Dapagliflozin 10mg QD|Dapagliflozin 10mg once daily for 12 weeks
16027803|NCT02682563|Drug|Gliclazide 30mg QD|Gliclazide30mg once daily for 12 weeks
16027804|NCT02682550|Procedure|blood drawing|blood drawing
16027805|NCT02682524|Drug|Pelubiprofen CR 45mg tab.|
16027806|NCT02682524|Drug|Aceclofenac 100mg tab.|
16027807|NCT02682511|Drug|Oral Ifetroban|Subjects will be treated with oral ifetroban or placebo daily for 365 days
16027808|NCT02682511|Drug|Oral Placebo|Subjects will be treated with oral ifetroban or placebo daily for 365 days
16027809|NCT02682498|Drug|(Bupivacaine Liposome Injectable Suspension)|Instead of injecting the standard joint injection for a case of total knee arthroplasty, Exparel-lipsomal bupivacaine will be administered at the end of the surgery.
16027810|NCT02682498|Drug|Standard Preparation|A standard joint injection of 100ml (Clonidine 80 mcg, Epinephrine 0.5mg, Ketorolac 30mg, Ropivacaine 246.25mg, and Sodium Chloride 0.9% 48.45 ml) will be injected into the soft tissues around the joint after surgery.
16027811|NCT02682485|Drug|Cipro, metronidazole, neomycin combo|During endoscopies after imaging, the anastomosis will be lavaged with an antibiotic solution composed of metronidazole, ciprofloxacin and neomycin
16027812|NCT02682485|Procedure|Serial Endoscopic Surveillance|Patients will undergo serial endoscopic surveillance consisting of three endoscopies: one intra-operative endoscopy (POD0) and two post-operative endoscopies (POD3-7, POD12-28). During endoscopies, the anastomosis will be lavaged with saline, the fluid will be collected by suction and images will be taken.
16027813|NCT02682485|Drug|Saline|During endoscopies after imaging, the anastomosis will be lavaged with a placebo direct topical saline solution
16027814|NCT02682472|Other|SettleIN - Adjustment to care programme|A programme for care home staff to support new residents with dementia quickly and successfully adjust to life in a care home
16027815|NCT02682459|Drug|Lisinopril|
16027816|NCT02682446|Drug|H pylori eradication|The regimen of H. pylori eradication was like that: 1-week conventional proton pump inhibitor (PPI) based triple therapy (lansoprazole 40 mg b.i.d., clarithromycin 500 mg b.i.d., and amoxicillin 1 g b.i.d. for a week) after confirmation of H. pylori infection. If the participants who initially failed to respond to the first eradication, they recommended to underwent second-line eradication therapy with the regimen of 7-day bismuth containing quadruple regimen [lansoprazole 40 mg b.i.d., tripotassium dicitrate bismuthate (Denol; Greencross Co., Seoul, Korea) 300 mg q.i.d. (three tablets 30 min before meals and one tablet 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d. for 1 week]
16027817|NCT02682433|Device|diagnostic hysteroscopy|Women who were routinely referred to perform diagnostic hysteroscopy. As part of the procedure, clear liquid is inserted into the uterine cavity. After the hysteroscopy, abdominal and vaginal sonar will be performed, and the findings will be recorded and will be compared. Immediately after completion of the office hysteroscopy, two-dimensional and three-dimensional sonar to demonstrate the uterine cavity and its walls will be performed while using the liquid which is left in the uterine cavity. It is important to note that no additional invasive operation will be performed beyond what is necessary to perform hysteroscopy. It should be emphasized that the sonar test will be performed immediately and in the same position as the hysteroscopy test. All procedures will be performed in women clinics or day hospitalization. It should be noted that the medical examinations will not be performed unless there are medical reasons.
16027818|NCT02682433|Device|diagnostic sonar test|Women who were routinely referred to perform diagnostic hysteroscopy. As part of the procedure, clear liquid is inserted into the uterine cavity. After the hysteroscopy, abdominal and vaginal sonar will be performed, and the findings will be recorded and will be compared. Immediately after completion of the office hysteroscopy, two-dimensional and three-dimensional sonar to demonstrate the uterine cavity and its walls will be performed while using the liquid which is left in the uterine cavity. It is important to note that no additional invasive operation will be performed beyond what is necessary to perform hysteroscopy. It should be emphasized that the sonar test will be performed immediately and in the same position as the hysteroscopy test. All procedures will be performed in women clinics or day hospitalization. It should be noted that the medical examinations will not be performed unless there are medical reasons.
16027819|NCT02682420|Device|everlinQ endoAVF System|
16027820|NCT02682407|Biological|OMS721 (narsoplimab)|Biological: OMS721 (narsoplimab)
16027821|NCT02682381|Drug|Teduglutide 0.05mg/kg|0.05 mg/kg
16027822|NCT02682381|Drug|Teduglutide 0.025 mg/kg|0.025 mg/kg
16027823|NCT02682381|Other|Standard of Care|Observational cohort for the 24-week treatment period and 4 week follow-up.
16027824|NCT02682368|Diagnostic Test|Point of Care Ultrasound by Surgeons (POCUSS)|"POCUSS-1. To identify the gallbladder and it's contents, complications and perform measurements, elicit sonographic Murphy.
~POCUSS-2: To perform focused left lower quadrant sonography and identify bowel wall thickness, diverticulae, measure the colonic wall thickness, assess pericolic fat and detect possible complications; evaluate sensibility on graded compression."
16027825|NCT02682368|Diagnostic Test|Radiology report|Radiologist report compared to the point of care ultrasound impression.
16027826|NCT02682368|Procedure|Surgery-Intra-operative findings|Intra-operative findings compared to the previously performed point of care ultrasound.
16027827|NCT02682342|Other|75 g glucose solution|This is the same as the standard oral glucose challenge dose and route given clinically
16027902|NCT02681744|Behavioral|Resistance Training|24-weeks of progressive strength training
16028529|NCT02677259|Drug|17-beta estradiol|
16027829|NCT02682329|Other|Hydrogen Peroxide and Hydrogen Peroxide|Hydrogen Peroxide + Hydrogen Peroxide were administered to each patient on this group. HP at home and HP at office
16027830|NCT02682316|Other|dry gauze|
16027831|NCT02682316|Device|The Prevena Incision Management System|
16027832|NCT02682303|Device|Elastic Bandage (Idealplast C®)|"Elastic bandage
~One anchor strip is applied around the ankle with no tension applied to the tape to avoid restricting blood flow. A supporting stirrup strap is applied from the inside of the ankle, under the heel with no tension up to this point. As the tape is passed up the outside of the ankle tension is applied to the tape with the foot in slight dorsiflexion and secured to the anchor strap (black arrow).
~For heel lock, a second strip is applied on the outside of the ankle, taken across the front of the ankle and just above the bony part on the inside of the ankle and back towards the heel (red arrow). Then taken around and under the heel back the way you have just come and around the front of the ankle (orange arrow). The tape then passes above the bony part of the ankle on the outside and diagonally towards the heel, across to the inside of the ankle then around the top to finish"
16027833|NCT02682303|Device|Pretape cramer® (non standarized tape)|"Pretape cramer® was used.
~The individual is in supine position keeping the foot and ankle in a neutral position.
~The strip (I) is applied with not stretch in the outside of the leg just above the ankle, and then the rest of the strip is applied on the outside of the ankle and under the heel.
~This is the only intervention carried out in this group."
16027834|NCT02682290|Other|Expectoration and measurement of sputum rheological properties|
16027835|NCT02682277|Device|polygucosamine|2 times daily 2 polyglucosamine tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity.
16027836|NCT02682277|Other|placebo|2 times daily 2 placebo tablets with the two main meals with 10 % reduction of caloric intake with no increase of physical activity.
16027837|NCT02682264|Drug|CB-03-01 cream, 1%|Cortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.
16027838|NCT02682251|Other|PHR Messaging|PHR messaging of data pertinent to chronic resynchronization therapy and heart failure management (i.e. percentage LV pacing).
16027839|NCT02682238|Drug|BBI-4000, 15%|
16027840|NCT02682238|Other|Vehicle gel|
16027841|NCT02682225|Drug|Intravenous placebo|Participants will receive placebo, 40-minute, intravenous infusion on Day 1 of Sequence 1, on Day 2 of Sequence 2, on Day 1 of Period 1 in Sequence 3, 5 and 6, on Day 1 of Period 2 in Sequence 3, 4 and 6, on Day 1 of Period 3 in Sequence 4, 5 and 6, and on Day 1 of Period 4 in Sequence 3, 4 and 5.
16027842|NCT02682225|Drug|Intranasal placebo|Participants will receive placebo, intranasally, on Day 1 or Day 2 in Sequence 1 and 2, on Day 1 of Period 1 in Sequence 3 and 4, on Day 1 of Period 2 in Sequence 4 and 5, on Day 1 of Period 3 in Sequence 3 and 6 and on Day 1 of Period 4 in Sequence 5 and 6.
16027843|NCT02682225|Drug|Intravenous racemic ketamine|Participants will receive 0.5 mg/kg racemic ketamine, intranasally, on Day 2 in sequence 1, on Day 1 in sequence 2, on Day 1 of Period 1 in Sequence 4, on Day 1 of Period 2 in Sequence 5, on Day 1 of Period 3 in Sequence 3, and on Day 1 of Period 4 in Sequence 6.
16027844|NCT02682225|Drug|Esketamine 112 mg|Participants will receive 112 mg of Esketamine, intranasally, on Day 1 of Period 1 in Sequence 6, on Day 1 of Period 2 in Sequence 3, on Day 1 of Period 3 in Sequence 5, and on Day 1 of Period 4 in Sequence 4.
16027845|NCT02682225|Drug|Esketamine 84 mg|Participants will receive 84 mg of Esketamine, intranasally, on Day 1 of Period 1 in Sequence 5, on Day 1 of Period 2 in Sequence 6, on Day 1 of Period 3 in Sequence 4, and on Day 1 of Period 4 in Sequence 3.
16027846|NCT02682212|Other|Physiotherapy intervention|Compare the effect of early physiotherapy intervention (pelvic floor muscle training, PFMT) with standard care on pelvic floor dysfunction symptoms, quality of life (QoL) and (pelvic floor muscle (PFM) strength, for women who answered the questionnaire positively for 1) urinary incontinence, 2) other dysfunction of the pelvic floor.
16027847|NCT02682186|Drug|Ropivacaine after dilution with sodium chloride 0.9%|"After the anesthesic induction, the interventional team composed by at least a senior anaesthesiologist and a nurse anesthestic, will survey the patient and perform the Pecs blocks, whereas the anesthetic team is outside the room.
~Realization of Pecs blocks 1 and 2 : the patient is in supine position with placing the upper limb in abduction position, a 100 mm needle is inserted under ultrasound using a linear US probe of high frequency after sheathing.
~In the other group, sterilization, sheating and US are performed but the needle is not inserted."
16027848|NCT02682173|Other|MR Abdomen|
16027849|NCT02682160|Other|use of Protein Assistant|The patient has to complete a dietary record every 2 weeks during 2 months (month 2 and 3 after surgery). The aim is to intake 60g per day. If the aim is not reached, Protein assistant suggests qualitative and/or quantitative solutions.
16027850|NCT02682147|Drug|Hypoxia administration study group|scan completed after 5 minutes of breathing in hypoxic air
16027851|NCT02682147|Drug|Hyperoxia administration study group|scan completed after up to 15 minutes of breathing in hyperoxic air
16027852|NCT02682147|Drug|Sildenafil|One dose of 20 mg Sildenafil will be given one hour before CT imaging.
16027853|NCT02682134|Drug|xylocaine|First group were given xylocaine
16027854|NCT02682134|Drug|Dexamethasone|Second group were given Dexamethasone
16027855|NCT02682134|Drug|Xylocaine and Dexamethasone|Third group were given both Xylocaine and Dexamethasone
16027856|NCT02682121|Drug|Metformin|Metformin 850 mg twice daily
16027857|NCT02682121|Drug|Placebo|Placebo twice daily
16027858|NCT02682108|Device|Diffusion-weighted magnetic resonance imaging (DW-MRI)|Magnetic resonance (MR) imaging examination of liver will be performed on a 3.0T Achieva MR scanner (Philips Medical Systems, The Netherlands). Diffusion-weighted imaging (DWI) will be performed using a single-shot echo-planar imaging during a single end expiratory breath-hold. A single observer placed circular regions of interest around 2.30 cm2 to measure mean signal intensity (SI) in the right hepatic lobe and the spleen for each b value, avoiding areas of artifact, vessels, and focal lesions. A monoexponential fit will be performed to calculate liver and spleen apparent diffusion coefficient (ADC) on the basis of ln(SI) as a function of b value, using all b values. Normalized liver ADC will be calculated as the ratio of liver ADC to spleen ADC.
16027859|NCT02682082|Procedure|Endoscopic ultrasound-guided celiax plexus neurolysis|Endoscopic ultrasound-guided celiax plexus neurolysis
16027860|NCT02682082|Drug|Bupivacaine|Endoscopic ultrasound-guided celiax plexus neurolysis w/wo Bupivacaine
16027861|NCT02682069|Device|MolecuLight i:X Imaging Device|The intended use of the device is to assist clinicians during care and management of patients with chronic wounds by screening for the presence of potentially harmful bacteria levels. The device will be used as part of the current clinical wound assessment process which may include examination for characteristic signs and symptoms of infection. The device can capture and document either an image or video of the chronic wound where the presence of florescent bacteria appears under violet light illumination. This information can be used to guide a clinician to inspect, sample, debride or further evaluate areas within or around a wound where fluorescent bacteria are present.
16027862|NCT02682056|Device|Microneedle patch|The microneedle patch will collect interstitial fluid to be tested for glucose level. The microneedles are made from biocompatible polymers or metal. Participants will have fasting glucose levels measured four times, on an hourly basis, during the study visit.
16027863|NCT02682056|Device|Intravenous (IV) catheter|The intravenous (IV) catheter will collect venous blood to be tested for glucose level. Participants will have fasting glucose levels measured four times, on an hourly basis, during the study visit.
16027864|NCT02682056|Device|Lancet|The lancet will collect capillary blood to be tested for glucose level. Participants will have fasting glucose levels measured four times, on an hourly basis, during the study visit.
16027865|NCT02682043|Device|Toy car|"The intervention is the provision of an electric toy car. This toy car will be modified to meet the postural and hand control preference of each child participant.
~The child will have the toy car for an 8 week trial period. Parents and child will be instructed in the safe use of the toy car, given written guidelines, and encouraged to use frequently.
~Parents will keep a log of what days they use the toy car, where and for how long."
16027866|NCT02682030|Device|High Frequency Chest Compression Device (HFCC)|A vest designed to help clear the airway of mucus and other secretions through mechanical knocking of the chest area.
16027867|NCT02682030|Device|Cough Assist|A device that aids patients to clear mucus and secretions that they would otherwise be unable to clear with coughing.
16027868|NCT02682017|Other|Pork meat from pigs feed with a standard feed.|4 week intervention with 700g (raw weight) of pork meat (3x pork burgers (125g raw weight each) + pork mince (325 g raw weight) per week.
16027869|NCT02682017|Other|Pork meat from pigs fed a feed with a Laminarin/fucoidan mix|4 week intervention with 700g (raw weight) of pork meat (3x pork burgers (125g raw weight each) + pork mince (325 g raw weight) per week from pigs fed animal feed supplemented (5.37 kg/tonne of feed) with spray-dried laminarin and fucoidan (seaweed).
16027870|NCT02682004|Other|leptin, serotonin and adiponectin level|
16027871|NCT02682004|Other|leptin,serotonin, adiponectin level|
16027872|NCT02681991|Drug|Renamezin capsule|
16027873|NCT02681978|Drug|Ivabradine|Ivabradine 5 mg twice daily
16027874|NCT02681978|Drug|Standard medical therapy|Standard medical therapy for patients with coronary artery disease undergoing percutaneous coronary interventions
16027875|NCT02681965|Behavioral|LEAN book/videos|The intervention focuses on achieving long lasting lifestyle changes to achieve weight loss and maintenance. Women randomized to the weight loss program will receive the LEAN book, as well as a CD and flash drive with the LEAN videos (and internet link), a pedometer and the Log Book for recording their food intake and physical activity.
16027876|NCT02681952|Drug|Renamezin capsule|
16027877|NCT02681952|Drug|Kremezin granule|
16027878|NCT02681939|Drug|Tulsi(Ocimum sanctum Linn.) capsules|
16027879|NCT02681926|Procedure|VISITAG|Paroxysmal atrial Fibrillation (PAF) ablation with contact force technology
16027880|NCT02681913|Drug|Adenosine|This group receives intermittent warm blood cardioplegia enriched with adenosine
16027881|NCT02681900|Behavioral|Self-affirmation manipulation task|Participants in the self-affirmation condition indicate their most important value, give three examples of why this value is important to them and one example of something they had done to demonstrate its importance.
16027882|NCT02681900|Behavioral|Control task|People in the control condition indicate their least important value, three examples of why that value could be important to someone else, and describe something that person could do to show its importance.
16027883|NCT02681887|Drug|Melatonin|Circadin, controlled release melatonin tablet 2mg by mouth each day before bedtime for 12 weeks
16027884|NCT02681887|Drug|Placebo|placebo tablet identical to circadian
16027885|NCT02681874|Behavioral|SSC Program|The Smart and Secure Children (SSC) program is a 10-week manualized intervention that uses a written validated curriculum. The program is group-based and co-led by peer leaders (Parent Leaders). Parent Leaders facilitate conversations on the SSC program content by sharing real life application, experiences, and solutions.
16027886|NCT02681874|Behavioral|Written Handouts|The handouts are a part of the SSC program that include didactic curriculum content and instruct parents to write goals and document goal progress.
16027887|NCT02681861|Drug|ASP6294 Intravenous|Intravenous (IV)
16027888|NCT02681861|Drug|ASP6294 Subcutaneous|Subcutaneous (SC)
16027889|NCT02681861|Drug|Placebo Intravenous|Intravenous (IV)
16027890|NCT02681861|Drug|Placebo Subcutaneous|Subcutaneous (SC)
16027891|NCT02681848|Drug|Varenicline|Smoking cessation medication
16027892|NCT02681848|Drug|Nicotine replacement therapy|
16027893|NCT02681835|Device|C-MAC laryngoscope|Intubation performed using C-MAC laryngoscope
16027894|NCT02681835|Device|Macintosh laryngoscope|Intubation performed using laryngoscope with Macintosh blade
16027895|NCT02681809|Drug|ocriplasmin 0.0625mg|Up to 3 intravitreal injections of ocriplasmin 0.0625mg approximately 1 month apart
16027896|NCT02681809|Drug|ocriplasmin 0.125mg|Up to 3 intravitreal injections of ocriplasmin 0.125mg approximately 1 month apart
16027897|NCT02681809|Drug|Sham injection|3 sham injections approximately 1 month apart. No actual injections. No medication is used.
16027898|NCT02681796|Drug|Bupivacaine|
16027899|NCT02681783|Drug|aflibercept|Therapeutic/Pharmacological Classification: VEGF - Anti-neovascularization agent Route(s) of Administration: Intravitreal Injection Dosage Form: Solution 40 mg/ml Proposed Indication: Treatment of Pigment Epithelial Detachments (PEDs) associated with neovascular Age-related Macular Degeneration (nAMD), Central serous chorioretinopathy (CSR), and idiopathic Poplypoidal Choroidal Vasculopathy (iPCV).
16027900|NCT02681757|Device|triple antibiotic ointment dressing|used for control group under soft cast
16028422|NCT02677987|Device|Intervention systematic light exposure|
16027903|NCT02681718|Behavioral|Community health worker education|Diabetes self-management education by community health workers
16027904|NCT02681718|Behavioral|Cell phone text messaging|Diabetes self-management education through cell phone text messaging
16027905|NCT02681705|Drug|Temozolomide|Temozolomide is applied to these patients as a chemotherapy drug with a dosage of 75mg/m2, daily. The chemotherapy and radiation are combined as temozolomide is taken 1 hour prior to every fraction of radiotherapy. In 4 weeks after the completion of radiotherapy, temozolomide is given for 8 cycles (dosage: the 1st cycle, 150mg/m2, daily × 5 days, 4 weeks a cycle; the 2-8th cycle, 200mg/m2, daily × 5 days, 4 weeks a cycle and repeated again).
16027906|NCT02681705|Radiation|Craniospinal Radiation|Craniospinal radiation will begin within 28 days of surgery. Craniospinal Radiation therapy will last for 6 weeks, five days per week. Once a week during radiation, subjects will also be treated with chemotherapy (Temozolomide).
16027907|NCT02681692|Device|Magnetic endoscopic imaging system|In the first part,patients would be randomly assigned to have colonoscopy examination performed by one inexperienced colonoscopist (having performed less than 200 procedures) with the assistance of magnetic scope navigation system In the second part colonoscopist would be randomized to perform conventional colonoscopy on a colon model with an MEI view while the force measurement device being used to collect data of colon force variation meanwhile. No patients would be involved in this part. All force variation data would be recorded by a image storage device.
16027908|NCT02681679|Drug|0.1% bromfenac ophthalmic solution|
16027909|NCT02681679|Procedure|femtosecond laser cataract surgery|
16027910|NCT02681666|Dietary Supplement|Dietary intervention|Sessions will be spent with patients discussing the FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides, and polyols) diet and how to use this diet to treat their Irritable Bowel Syndrome.
16027911|NCT02681666|Behavioral|Irritable Bowel Syndrome eating awareness training|A type of meditation about their eating habits.
16027912|NCT02681653|Drug|Atorvastatin|Atorvastatin or placebo given for 7 days to patients of septic shock admitted to ICU
16027913|NCT02681653|Drug|Placebo|Equally matched placebo for 7 days to patients of septic shock admitted to ICU
16027914|NCT02681640|Other|68Ga-NOTA-AE105|One injection of 68Ga-NOTA-AE105
16027915|NCT02681640|Device|Positron Emission Tomography PET/CT|Following injection of 68Ga-NOTA-AE105 the patients will be subjected to Positron Emission Tomography PET/CT
16027916|NCT02681627|Other|Endometrial scratch|If patient randomised to intervention arm, will have speculum examination followed by endometrial scratch with a wallace catheter
16027917|NCT02681627|Other|Touching the cervix|If patient is randomised to the control arm, she will have speculum examination followed by cleaning of the cervix with a cotton tip dipped in saline
16027918|NCT02681614|Device|Uronav guided biopsy|"All biopsies will be completed in the outpatient setting in the ambulatory operating room prior to routine prostate brachytherapy under general anesthesia.
~Patients will be prepped in a dorsal lithotomy position with insertion of a Foley catheter. The perineum will be shaved as needed, and cleansed with antiseptic solution, and the scrotum will be elevated with a towel roll to expose the perineum."
16027919|NCT02681614|Device|Magnetic resonance imaging|An MRI (magnetic resonance imaging) is a scan that uses radio waves and a strong magnetic field to provide images of internal organs and tissues. This is not part of the study but will have been done per standard treatment. An MRI will occur at the screening visit and last visit of the study.
16027920|NCT02681601|Dietary Supplement|Nutrawell Powder|"The NutraWell nutrition powder will be provided by and distributed from New Health Nutraceuticals (Irvine, California - USA). Nutrawell is manufactured New Health Enterprises, Inc. The supplement sample will be stored at room temperature in the UCLA Center for Human Nutrition research unit.
~OmegaRich Contains high concentration and high purity of natural omega-3 polyunsaturated fatty acids: Eicosapenatenoic acid (EPA) and docosahexaenoic acid (DHA) from deep water fish.
~Enriched with natural vitamin E: d- tocopherol Triglyceride form (TG-form) of the raw fish oil ingredients. Each fish oil capsule contains 55% EPA and DHA with 330 mg EPA and 220 mg DHA."
16027921|NCT02681601|Other|Diet Only|Subjects will be evaluated by a registered dietitian and randomized to diet prescription (55% carbohydrate, 30% fat and 15% protein)
16027922|NCT02681601|Dietary Supplement|OmegaRich fish oil supplement|"OmegaRich is manufactured New Health Enterprises, Inc. The supplement sample will be stored at room temperature in the UCLA Center for Human Nutrition research unit.
~OmegaRich Contains: high concentration and high purity of natural omega-3 polyunsaturated fatty acids: Eicosapenatenoic acid (EPA) and docosahexaenoic acid (DHA) from deep water fish.
~Enriched with natural vitamin E: d- tocopherol Triglyceride form (TG-form) of the raw fish oil ingredients. Each fish oil capsule contains 55% EPA and DHA with 330 mg EPA and 220 mg DHA."
16027923|NCT02681588|Procedure|Obstetric management|Screening for gestational diabetes at 32 weeks of gestation, determination of fasting glucose during late pregnancy ; blood samples on arrival at the delivery room ; drawing blood from the umbilical cord after section; skinfold measurement of the newborn within 72 hours of life.
16027924|NCT02681575|Behavioral|Cog-Fun - A|Meta-cognitive functional intervention for improved self management in adults with ADHD
16027925|NCT02681562|Drug|olaparib|
16027926|NCT02681549|Drug|Pembrolizumab plus Bevacizumab|Pembrolizumab will be administered on day 1 of every cycle until disease progression or withdrawal from study. Bevacizumab will be administered in addition to pembrolizumab on day 1 of cycles 1, 2, 3, and 4 (or alternative cycles if bevacizumab is held during these cycles). Three weeks constitutes one cycle.
16027927|NCT02681536|Drug|Triptorelin|
16027928|NCT02681536|Drug|Combined oral contraceptive pills|
16027929|NCT02681536|Drug|HMG|
16027930|NCT02681523|Drug|Eribulin|
16027931|NCT02681510|Drug|Varenicline|Standard FDA approved 12 weeks of treatment with Varenicline
16027932|NCT02681510|Drug|Nicotine Transdermal Patch|Standard FDA approved 12 weeks of treatment with Nicotine Transdermal Patch
16027933|NCT02681510|Drug|Nicotine Mini|Standard FDA approved 12 weeks of treatment with Nicotine Mini-Lozenge
16027934|NCT02681484|Behavioral|Anthroposophic speech therapy|"Anthroposophic speech therapy uses sound-combinations like KLSFM or OM and hexameter verse in German, spoken by the therapist and imitated by the patients, to expand and decelerate respiration. The intervention is conducted by the same qualified therapist for one patient in different days but during the same daytime for 30 minutes in upright position and walking."
16028423|NCT02677987|Device|Comparison systematic light exposure|
16027935|NCT02681471|Other|5% Mannitol|Traditional monopolar TURP was performed by using and irrigation fluid containing 5% mannitol ( Resectisol Eczacibasi-Baxter).
16027936|NCT02681471|Other|0,9% Sodium chloride|Bipolar TURP was carried out by using a 24 Fr TURis (OLYMPUS) resectoscope and irrigation fluid containing 0,9 % sodium chloride.
16027937|NCT02681471|Device|monopolar resectoscope|
16027938|NCT02681471|Device|bipolar resectoscope TURis|
16027939|NCT02681458|Other|Direct Examination|It was an observational study and subjects received their routine treatment.
16027940|NCT02681445|Device|Breath Collection|breath will be collected from patients in breath bag for analysis for observational study.
16027941|NCT02681432|Drug|HIPEC|Cytoreductive surgery and Hyperthermic Intraperitoneal Chemotherapy (HIPEC) with Paclitaxel (175 mg/m2) for 60 minutes at 42-43 degrees.
16027942|NCT02681432|Procedure|No HIPEC|Cytoreductive surgery without HIPEC
16027943|NCT02681419|Procedure|Needle fenestration|This technique creates fenestrations along a nonvalved glaucoma implant (e.g. Baerveldt Glaucoma Implant) anterior to the ligature
16027944|NCT02681419|Procedure|Suture wick|This technique places a single 10-vicryl suture wick through the nonvalved glaucoma implant (e.g. Baerveldt Glaucoma Implant) anterior to the ligature
16027945|NCT02681406|Behavioral|ACHESS|Smartphone based additions focused application, encouraging social support
16027946|NCT02681406|Behavioral|TMC|Brief telephone monitoring and counseling
16027947|NCT02681393|Behavioral|Brochure and Telephone Support|Participants will receive both the Aerobic Exercise After Stroke educational brochure and 4 weekly motivational telephone support calls.
16027948|NCT02681393|Behavioral|Brochure|Participants will receive both the Aerobic Exercise After Stroke educational brochure.
16027949|NCT02681380|Other|Relation learning|Seven session are planned. Each will be supervised by a senior, trained to supervised Balint group.
16027950|NCT02681380|Other|Control group|No session will be planned for the participants.
16027951|NCT02681367|Other|Freeze all policy|Cryopreservation of human blastocysts for freeze all group has been employed using vitrification. The blastocysts were transferred after thawing in a frozen-thawed cycle.
16027952|NCT02681354|Other|Biorescue training|
16027953|NCT02681328|Other|Afirma GEC|Afirma GEC molecular test on collected thyroid tissue
16027954|NCT02681328|Other|ThyroSeq v.2|ThyroSeq v.2 molecular test on collected thyroid tissue
16027955|NCT02681328|Other|Afirma GSC|Afirma GSC molecular test on collected thyroid tissue
16027956|NCT02681328|Other|ThyroSeq v.3|ThyroSeq v.3 molecular test on collected thyroid tissue
16027957|NCT02681315|Device|HHHFNC 6 liter minute|Infants allocated to HHHFNC at 6 L/min. will be extubated to a HHHFNC flow of 6 L/min. Eligible infants will be enrolled while receiving mechanical ventilation. The timing of extubation will be determined by the clinical team and all infants will start caffeine prior to extubation.
16027958|NCT02681315|Device|HHHFNC 3 liters/min|Infants allocated to HHHFNC at 3 L/min. will be extubated to a HHHFNC flow of 3 L/min. Eligible infants will be enrolled while receiving mechanical ventilation. The timing of extubation will be determined by the clinical team and all infants will start caffeine prior to extubation.
16027959|NCT02681302|Drug|Ipilimumab|1 mg/kg; 6 doses Weeks 1, 4, 7, 10, 16, 22
16027960|NCT02681302|Drug|Nivolumab|3 mg/kg; 12 doses Weeks 1, 4, 7, 10, 12, 14, 16, 18, 20, 22, 24, 26
16027961|NCT02681289|Other|Early goal directed neuromotor therapy|Early goal directed neuromotor therapy (NGDT) is referred to as 'task-oriented' and is built on contemporary system theories of motor control. The development and learning of new skills occur in an interaction between the child, the task to be performed and the particular environment in which the activity takes place.
16027962|NCT02681276|Procedure|Irrigation with 3% NaOCl|All the operators are informed to perform the endodontic treatment the way they normally do. The only variation during treatment was the concentration of the sodium hypochlorite solution for irrigation of the root canal.
16027963|NCT02681276|Procedure|Irrigation with 0.5% NaOCl|All the operators are informed to perform the endodontic treatment the way they normally do. The only variation during treatment was the concentration of the sodium hypochlorite solution for irrigation of the root canal.
16027964|NCT02681263|Drug|Temocillin|Treatment duration with a minimum of 5 days administration of the study drug: Temocillin (Negaban®) 6g/day (2g/tid) and as monotherapy.
16027965|NCT02681250|Procedure|Titanium-zirconium|Titanium-zirconium implants will be installed according to the protocol earlier described in the detailed description.
16027966|NCT02681250|Procedure|Titanium|Titanium implants will be installed according to the protocol earlier described in the detailed description.
16027967|NCT02681237|Drug|Cediranib|Small-molecule inhibitor of several tyrosine kinases including VEGFR-1, VEGFR-2, VEGFR-3 and c-kit.
16027968|NCT02681237|Drug|Olaparib|Poly (ADP-ribose) polymerase (PARP) inhibitor.
16027969|NCT02681224|Other|TR987 Gel with Silon Bandage|Novel healing gel with occlusive dressing
16027970|NCT02681224|Other|TR987 without Silon Bandage|Novel healing gel without occlusive dressing
16027971|NCT02681224|Other|Placebo Gel with Silon Bandage|Placebo gel with occlusive dressing
16027972|NCT02681224|Other|Placebo Gel without Silon Bandage|Placebo Gel without occlusive dressing
16027973|NCT02681211|Other|Auricular Acupuncture|ASP (acupuncture semi-permanent) gold needles will be placed in the efficacious ear points with a maximum of 3 needles in each ear.
16027974|NCT02681211|Drug|Ketorolac 0.5mg/kg, max 30mg|"If assigned to receive intravenous medications and fluid the subject will be treated with the ED standard of care medications which include:
~Ketorolac 0.5mg/kg, max 30mg
~Metoclopramide 0.1 mg/kg, max 10mg
~Diphenhydramine 1mg/kg, max 50mg
~Normal saline fluid bolus 20mL/kg, max 1000mL"
16027975|NCT02681211|Drug|Metoclopramide 0.1 mg/kg, max 10mg|"If assigned to receive intravenous medications and fluid the subject will be treated with the ED standard of care medications which include:
~Ketorolac 0.5mg/kg, max 30mg
~Metoclopramide 0.1 mg/kg, max 10mg
~Diphenhydramine 1mg/kg, max 50mg
~Normal saline fluid bolus 20mL/kg, max 1000mL"
16027976|NCT02681211|Drug|Diphenhydramine 1mg/kg, max 50mg|"If assigned to receive intravenous medications and fluid the subject will be treated with the ED standard of care medications which include:
~Ketorolac 0.5mg/kg, max 30mg
~Metoclopramide 0.1 mg/kg, max 10mg
~Diphenhydramine 1mg/kg, max 50mg
~Normal saline fluid bolus 20mL/kg, max 1000mL"
16028530|NCT02677259|Drug|Micronized progesterone|
16135132|NCT01896349|Drug|Risperidone|
16027977|NCT02681211|Drug|Normal saline fluid bolus 20mL/kg, max 1000mL|"If assigned to receive intravenous medications and fluid the subject will be treated with the ED standard of care medications which include:
~Ketorolac 0.5mg/kg, max 30mg
~Metoclopramide 0.1 mg/kg, max 10mg
~Diphenhydramine 1mg/kg, max 50mg
~Normal saline fluid bolus 20mL/kg, max 1000mL"
16027978|NCT02681198|Drug|Lofexidine|All subjects will receive two single doses of lofexidine HCl; one 0.4 mg dose taken alone on Day 1 and one 0.4 mg dose taken with 40 mg once daily paroxetine HCl at steady-state on Day 13.
16027979|NCT02681198|Drug|Paroxetine|All subjects will receive daily single doses of paroxetine HCl; one 20 mg dose taken Days 4-6, one 40 mg dose taken Days 7-19, one 20 mg dose taken Day 20, one 10 mg dose taken Days 21-22.
16027980|NCT02681185|Other|Virtual Care|"Virtual Care consists of the following services and resources:
~Have a virtual consult through online methods or telephone with one of the study endocrinologists
~Be encouraged to report blood sugar readings every 2 weeks to their endocrinologist for regular follow-up and feedback via online methods
~Be given access to a website with modules that attempt to replicate the information learned in a diabetes teaching clinic
~Be given access to a certified diabetes educator through online methods or telephone. This will cover any other information that cannot be personalized on the teaching website, such as specific diet advice and social support."
16027981|NCT02681185|Other|Standard of Care|Standard of care offered in the patient's community. May involve in-person education at a diabetes centre and consultation with a healthcare professional.
16027982|NCT02681172|Drug|Neuraceq (florbetaben 18F)|Florbetaben 18F is given as an i.v. injection followed by a flush of sodium chloride solution to ensure full delivery of the dose.
16027983|NCT02681172|Procedure|PET|A brain PET scan is usually taken 90 minutes after the i.v. injection of florbetaben 18F.
16027984|NCT02681146|Other|Multimodal intervention|Educational advice + physiotherapist treatment
16027985|NCT02681133|Other|Epidemiological study Survey|
16027986|NCT02681120|Procedure|Biopsy|
16027987|NCT02681120|Procedure|Blood draw|
16027988|NCT02681120|Procedure|Mammogram|
16027989|NCT02681120|Procedure|MRI|
16027990|NCT02681107|Radiation|APBI 27Gy in 5 fractions|Patients will be treated with 3-D conformal, external beam, partial breast RT to deliver 27 Gy in 5 daily fractions using 3-5 beams on a linear accelerator. The target PTV will be the CT-visible seroma plus a 1cm margin to form the CTV (minus 5mm from skin and excluding chest wall) and a further 7mm to form the PTV. Real time review will ensure compliance with target and normal tissues dose constraints in this multi-institutional study. Any (or no) systemic therapy is permitted.
16027991|NCT02681094|Drug|Dapagliflozin|5mg, orally, Green, plain, diamond-shaped, film-coated tablet
16027992|NCT02681094|Drug|Placebo for Dapagliflozin|Does not contain active ingredient, orally, Green, plain, diamond-shaped, film-coated tablet
16027993|NCT02681094|Drug|Saxagliptin|5mg, orally, Plain, yellow, biconvex, round, film-coated tablet
16027994|NCT02681094|Drug|Placebo for Saxagliptin|Does not contain active ingredient, orally, Plain, yellow, biconvex, round, film-coated tablet
16027995|NCT02681081|Other|Glucose Administration|For sessions 2 through 4, participants will fast for two hours prior to each session and consume 25-30 g of glucose at the start of each session.
16027996|NCT02681081|Other|Intermittent Fasting|For sessions 2 through 4, participants will fast for 16 hours prior to the session (no food or beverages other than non-caloric beverages or coffee after 6 or 7 pm the evening prior).
16027997|NCT02681081|Other|Control|Normal food intake
16027998|NCT02681068|Other|Fecal microbiota transplantation (FMT)|Fecal microbiota transplantation (FMT) for patients with Clostridium difficile associated diarrhea
16027999|NCT02681055|Drug|MN-001|MN-001 is a novel, orally bioavailable small molecule compound which demonstrates anti-inflammatory activity
16028000|NCT02681042|Procedure|Left atrial appendage closure|The SentreHeart Lariat® device (that is approved for soft tissue ligation) will be used to ligate or close the left atrial appendage as a stand-alone procedure at the participating centers.
16028001|NCT02681042|Device|SentreHeart Lariat®|The SentreHeart Lariat® device (that is approved for soft tissue ligation) will be used to ligate or close the left atrial appendage as a stand-alone procedure at the participating centers.
16028002|NCT02681029|Procedure|Blastocyte Transferring|Intra-uterine transferring of blastocyst from thawed cleavage embryo in infertile women.
16028003|NCT02681029|Procedure|Embryo Transferring|Inta-uterine transferring of thawed cleavage embryo transfer in infertile women.
16028004|NCT02681016|Device|"DES Calypso"|A standard endovascular procedure is carried out under local anesthesia and under fluoroscopic control. Stenosis of coronary artery is passed by the hydrophilic coronary wire. Then balloon angioplasty of target lesion (if required) is provided. After the angiographic control coronary stent is implanted. After coronary wire removing control angiographic study is provided. Medical therapy includes aspirin(acid acetylsalicylic) 125 - 300 mg/d and plavix(clopidogrel) in dose 300-600 mg prescription before the procedure and heparin (heparin sodium) injection during the procedure(5000 U iv). After the procedure aspirin(acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and plavix(clopidogrel) in dose 75/d should be prescribed within 12 months.
16028005|NCT02681016|Device|"DES Xience Prime"|A standard endovascular procedure is carried out under local anesthesia and under fluoroscopic control. Stenosis of coronary artery is passed by the hydrophilic coronary wire. Then balloon angioplasty of target lesion (if required) is provided. After the angiographic control coronary stent is implanted. After coronary wire removing control angiographic study is provided. Medical therapy includes aspirin(acid acetylsalicylic) 125 - 300 mg/d and plavix(clopidogrel) in dose 300-600 mg prescription before the procedure and heparin (heparin sodium) injection during the procedure(5000 U iv). After the procedure aspirin(acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and plavix(clopidogrel) in dose 75/d should be prescribed within 12 months.
16028006|NCT02681016|Procedure|Coronary angioplasty|
16028007|NCT02680990|Behavioral|Band Together|Band Together is a strength training program utilizing resistance bands with progressively increasing resistance, ranging from 3 to 35 pounds. Sessions are to be completed 3 times a week and involve 3 sets of 6 exercises: 1. chair stands, 2. chest press, 3. shoulder press, 4. arm curls, 5. pulls, and 6. calf raises. In addition, Band Together participants will be asked to work up to a walking goal of 10,000 additional steps per week.
16028424|NCT02677974|Device|On-X Aortic Heart Valve replacement|Aortic valve replacement with low dose warfarin
16028008|NCT02680990|Other|Exercise Education|Education will consist of counseling by the healthcare provider with supplemental handouts from the American College of Sports Medicine and the National Institute on Aging/ National Institutes of Health.
16028009|NCT02680977|Other|MP-Equivalent|Mucuna pruriens powder at equivalent dosage than LD+DDCI. The dose of MP is calculated to obtain a 5-fold Levodopa dose than LD+DDCI.
16028010|NCT02680977|Other|MP-Low|Mucuna pruriens powder at low dosage. The dose of MP is calculated to obtain a 3.5-fold Levodopa content than LD+DDCI
16028011|NCT02680977|Other|MP+DDCI|Mucuna pruriens powder plus Benserazide. The dosage of MP is calculated to obtain the same Levodopa content than LD+DDCI. Benserazide is given as 1:4 ratio with Levodopa.
16028012|NCT02680977|Drug|LD+DDCI|Levodopa plus Benserazide
16028013|NCT02680977|Drug|LD-DDCI|Levodopa without any DDCI
16028014|NCT02680977|Other|Placebo|Groundnuts powder
16028015|NCT02680951|Drug|Dasatinib|Administered orally on a once daily schedule based on the dose level assigned to the patient at enrollment (60, 80, or 100mg/m2/day). Patients may adjust the time they take dasatinib as long as they take the drug approximately every 24 hours
16028016|NCT02680951|Drug|Fludarabine|"30 mg/m2/dose, intravenous infusion over 30 minutes, once daily, on days 1 to 5, total 5 doses
~Participants with body weight less than 12Kg, the fludarabine dose will be corrected as follows: [weight (Kg) x dose (per m2)] divided by 30"
16028017|NCT02680951|Drug|Cytarabine|"2000 mg/m2/dose intravenous infusion over 1 to 3 hours, starting 4 hours after the beginning of fludarabine, once daily, on days 1 to 5, total 5 doses
~Participants with body weight less than 12Kg, the cytarabine dose will be corrected as follows: [weight (Kg) x dose (per m2)] divided by 30"
16028018|NCT02680951|Drug|Idarubicin|"8mg/m2/dose intravenous infusion over 15 minutes, once daily, on days 3 to 5, total 3 doses
~Participants with body weight less than 12Kg, the idarubicin dose will be corrected as follows: [weight (Kg) x dose (per m2)] divided by 30"
16028019|NCT02680951|Drug|Intrathecal (IT) cytarabine|"Given intrathecally to all participants on day 1 of course 1 and 2. Omit on day 1 of course 1 if participant received IT therapy within 7 days prior to study enrollment. Intrathecal chemotherapy may be given during the end of course 1 disease evaluation (spinal fluid and bone marrow aspiration) and may be repeated every 7 days with bone marrow evaluations per institutional preference.
~Cytarabine dose defined by age:
~30 mg for patients age 1 - 1.99
~50 mg for patients age 2 - 2.99
~70 mg for patients ≥3 years of age
~The participant may receive intrathecal triple therapy (ITT) if persistent blasts are present in the cerebral spinal fluid (CSF) based on the treating physician's clinical judgment."
16028020|NCT02680938|Drug|oxytocin|"For each participant, the duration of the third stage of labor (the time period between the delivery of the fetus and the delivery of the placenta) will be recorded.
~- The two groups will be compared in the following terms:
~The duration of the third stage of labor by stopwatch.
~Hemoglobin (Hb) difference before and 12 h after delivery.
~The need for manual delivery of the placenta. Manual removal of the placenta will be commonly carried out under general sedation in the operating room, if the placenta will not be delivered 30 min after fetal delivery."
16028021|NCT02680938|Drug|saline|"For each participant, the duration of the third stage of labor (the time period between the delivery of the fetus and the delivery of the placenta) will be recorded.
~- The two groups will be compared in the following terms:
~The duration of the third stage of labor by stopwatch.
~Hemoglobin (Hb) difference before and 12 h after delivery.
~The need for manual delivery of the placenta. Manual removal of the placenta will be commonly carried out under general sedation in the operating room, if the placenta will not be delivered 30 min after fetal delivery."
16028022|NCT02680925|Procedure|lung protective ventilation|TV 4 ml/kg during one lung ventilation and 6 ml/kg during two-lung ventilation with PEEP of 6 cmH2O
16028023|NCT02680925|Procedure|Conventional ventilation|TV 8 ml/kg during one lung ventilation and 10 ml/kg during two-lung ventilation without PEEP
16028024|NCT02680912|Device|Warm needle acupuncture|There will be 4-6 points used per knee, therefore 8-12 needles per treatment. Two points will be used as the core treatment ST 35 dubi, Ex-LE 5 xiyan. Four other acu-points can also be used from the following: Ahshi painful points local to the knee (locus dolendi), ST 36 zusanli, GB 34 yanglingquan, Sp 9 yinlingquan, ST34 liangqiu, Sp 10 xuehai, GB 33 yangxiguan, LR 7 xiguan, LR 8 ququan, heding Ex-LE 2 In addition to the acupuncture needles the warm needle acupuncture group will receive moxibustion on up to 4 points. Smokeless moxa will be used.
16028025|NCT02680912|Device|Needle acupuncture|The point selection protocol will be exactly the same as the experimental group
16028026|NCT02680899|Behavioral|Curricular Intervention|The intervention is a novel grades 7 and 8 InSciEd Out curriculum in mental health and addiction called My Mind, My Body.
16028027|NCT02680886|Device|Novosyn® Quick|Skin closure
16028028|NCT02680873|Other|SASI bypass|he operation was done under general anesthesia. The technique commences with the devascularization of the greater curvature of the stomach with the harmonic scalpel.junction. The stomach is then tubularized over a 36 French calibration tube, with a linear stapler charged with a green cartridge, commencing 6 cm proximal to the pylorus. The ileocecal junction is identified and 250 cm is measured upwards. The selected loop is ascended antecolic without division of the greater omentum, and a stapled isoperistaltic side-to-side to the anterior wall of the antrum of the stomach just cranial 3 cm away from the pylorus with a linear stapler charged with a green cartridge.
16028029|NCT02680847|Drug|ALO-02|Oral/Capsule, twice per day dosing; Treatment duration consists of a 1 to 4 week Conversion/Titration Phase leading to a 2 to 4 week Maintenance Treatment duration.
16028030|NCT02680834|Device|Dual Action Pneumatic Compression Device|Dual action pneumatic compression device used to treat chronic VLUs.
16028031|NCT02680834|Device|Multi-Layer Bandaging|Multi-layer bandaging used to treated chronic VLUs
16028032|NCT02680821|Procedure|ALL reconstruction (Anterolateral ligament)|
16028033|NCT02680821|Procedure|ACL revision (Anterior cruciate ligament )|
16028034|NCT02680808|Drug|Midazolam with F901318|Pharmacokinetics of midazolam with F901318
16028035|NCT02680795|Drug|Belinostat IV|"Cohort A:
~Belinostat 1000mg will be administered once daily on days 1 through 5 of one 21-day cycle via 30-minute IV infusion.
~Cohort B:
~Belinostat 1000mg will be administered once daily on days 1 through 5 of one 21-day cycle via 30-minute IV infusion.
~Cohort C:
~Belinostat 750mg will be administered once daily on days 1 through 5 of one 21-day cycle via 30-minute IV infusion."
16028425|NCT02677961|Other|Observation|
16028426|NCT02677948|Drug|Pacritinib|
16028427|NCT02677948|Drug|Ibrutinib|
16028036|NCT02680782|Drug|X4P-001|100 mg capsules, administered orally for 10 days either as 200 mg BID or 400 mg QD. Subjects will be randomized to determine if they will receive the drug QD or BID in the first dosing period.
16028037|NCT02680769|Dietary Supplement|300 mg of citrate Mg|This group will take an oral supplementation of 300 mg of citrate magnesium
16028038|NCT02680769|Other|Placebo|This group will take a placebo
16028039|NCT02680756|Drug|Ferric Maltol|
16028040|NCT02680756|Drug|Ferric Carboxy Maltose|
16028041|NCT02680743|Other|Education of parents to pursue prompt hearing screening.|Parents of patients will be counseled on the risks of hearing loss with a positive screen.
16028042|NCT02680730|Behavioral|Listening Project Protocol|The filtered-music intervention will consist of listening to computer-altered acoustic stimulation, designed to modulate the frequency band of vocal music passed to the participant. The frequency characteristics of the acoustic stimulation are selected to emphasize the relative importance of specific frequencies in conveying the information embedded in human speech. Modulation of the acoustic energy within the frequencies of human voice, similar to an exaggerated vocal prosody, are hypothesized to recruit and modulate the neural regulation of the middle ear muscles and to functionally reduce sound hypersensitivities and improve auditory processing.
16028043|NCT02680717|Drug|Clobetasol|ointment, twice daily (alternating weeks)
16028044|NCT02680717|Drug|Calcipotriene|ointment, twice daily
16028045|NCT02680717|Drug|Tacrolimus|ointment, 0.1%, twice daily
16028046|NCT02680704|Other|PEEP titrated mechanical ventilation|Enrolled patients will receive a sequential, step-wise increase in positive end-expired pressure from 5 cmH2O to 15 cmH2O. Intracranial pressure, transpulmonary pressure, vitals, and mechanical ventilator data will be measured at each increment. PEEP will be increased by increments of 5 cmH2O. The mode of mechanical ventilation (pressure or volume control), inspiratory time and fraction of inspired oxygen (FIO2) will be determined by the critical care team caring for the patient. In the event that PEEP is set > 5 cmH2O, measurements will be obtained from that starting point and increased to a maximum of 15 cmH2O. The physiologic measurements will be obtained at regular intervals (within 5 minutes at each PEEP level) throughout the PEEP titration period.
16028047|NCT02680691|Other|Robot, then conventional training|Robot assisted gait training from the baseline, then conventional gait training at 4 weeks after baseline
16028048|NCT02680691|Other|Conventional, then robot training|Conventional gait training from the baseline, then robot assisted gait training at 4 weeks after baseline
16028049|NCT02680678|Other|Colloid Preload|preload infusion
16028050|NCT02680678|Other|colloid co-load|co-load infusion
16028051|NCT02680678|Other|Crystalloid preload|preload infusion
16028052|NCT02680678|Other|Crystalloid Co-load|co-load infusion
16028053|NCT02680639|Device|BiPAP Synchrony ventilator|The BiPAP Synchrony ventilator will be used to determine Expiratory Positive Airway Pressure (EPAP). The ventilator will be used with varying pressure supports and oscillations depending on what arm of the study the participant is in.
16028054|NCT02680626|Drug|Magnesium Sulfate|Given via transversus abdominis plane block
16028055|NCT02680626|Drug|Ropivacaine|Given via transversus abdominis plane block
16028056|NCT02680613|Behavioral|Motivational SMS|Behaviour change messages delivered via SMS developed with the theoretical guidance of the Health Belief Model.
16028057|NCT02680613|Behavioral|Travel Voucher|A code for return public transportation to closest cervical cancer screening clinic included in the research.
16028058|NCT02680600|Drug|Cefepime dosing|Patients will received cefepime administered per standard-of-care as a 30 min intravenous infusion. Dosing will be based on local guidelines (the Sanford guide to antimicrobial therapy 2012-2013) using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine formula to estimate glomerular filtration rate (GFR).
16028059|NCT02680600|Other|Blood sampling|Blood will be sampled immediately prior to dose administration (time = 0 at the start of the 30 min infusion), at 0.5, 1, 3, 5 hours post-start of infusion and just before the subsequent dose. From day two onwards, samples will be taken at the end of the infusion and just before the next dose. For the quantification of cefepime, a validated solid phase extraction-liquid chromatography electrospray-tandem mass spectrometry method will be used.
16028060|NCT02680600|Other|Urine sampling|Timed urine collections were taken during one dosing interval (8 hours in a three times daily regimen) every day.
16028061|NCT02680600|Other|Determination of renal markers|Creatinine (modified Jaffe method) and urea in serum will be determined using an Architect c16000 analyzer (Abbott, Chicago, IL, USA). Cystatin C will be determined using a particle-enhanced immunonephelometric assay (N Latex Cystatin C, Siemens Healthcare Diagnostics, Marburg, Germany) by use of a BN II nephelometer (Siemens Healthcare Diagnostics). This assay has a calibration traceable to the first certified reference material for cystatin C in human serum (ERM-DA471/IFCC). Kidney injury molecule-1 (KIM-1) in urine and uromodulin in serum will be determined using commercially available ELISA assays: Quantikine ELISA Human TIM-1/KIM-1/HAVCR (R&D Systems, Minneapolis, MN, USA) and Uromodulin ELISA (Euroimmun, Luebeck, Germany), respectively.
16028062|NCT02680600|Other|Population pharmacokinetic modeling|The cefepime concentration versus time data will be fitted using the FOCE-I estimation algorithm in NONMEM® (Version 7.3; GloboMax LLC, Hanover, MD, USA). R® (R foundation for statistical computing, Vienna, Austria) will be used to graphically assess the model's goodness-of-fit and to evaluate the model's predictive capabilities. As a measure of prediction error, the absolute prediction error (APE) will be used. In short, the measured cefepime concentrations for each individual i at time point j were compared against the population predicted cefepime concentrations, i.e. the predictions for each individual without taking into account the between-subject variability (PRED in NONMEM). The distribution of APEs will be summarized by the median and 90% percentile.
16028063|NCT02680600|Other|Covariate screening|Renal function will be assessed by four serum based kidney markers (serum creatinine, cystatin C, urea and uromodulin) and two urinary markers (measured creatinine clearance (CrCl) and KIM-1, both on timed urine collections). Serum creatinine and cystatin C will also be used to calculate the eGFR based on CKD-EPI formulas.
16028064|NCT02680600|Other|Monte Carlo simulations|Based on the final covariate model, a Monte Carlo-based simulation study will be performed to evaluate the Sanford dose recommendations for ICU patients.
16028065|NCT02680587|Radiation|SBRT|SBRT (1-5 fractions) will be administered.
16028428|NCT02677935|Other|Community education programs|
16028429|NCT02677922|Drug|AG-120|
16028066|NCT02680587|Drug|DCFPyL-PET/MRI or -PT/CT|Estimate the proportion of DCFPyL-PET/MRI or -PET/CT positive sites that are positive for new or progressive metastatic disease by bone scan at 6-months from SBRT and vice versa
16028067|NCT02680587|Other|Observational (no SBRT)|These patient will not receive SBRT. They will be observed.
16028068|NCT02680574|Drug|vadadustat|oral tablet
16028069|NCT02680574|Drug|darbepoetin alfa|Subcutaneous
16028070|NCT02680561|Drug|Fluticasone Propionate MDPI|
16028071|NCT02680561|Drug|Fluticasone Propionate/Salmeterol MDPI|
16028072|NCT02680561|Drug|Fluticasone propionate/salmeterol|
16028073|NCT02680548|Drug|0.9% saline|
16028074|NCT02680548|Drug|0.25% bupivacaine hydrochloride injectable suspension USP|
16028075|NCT02680548|Drug|4mg/cc methylprednisolone acetate injectable suspension USP|
16028076|NCT02680535|Device|AuroShell particle infusion|Infuse AuroShell particles for irradiation by AuroLase laser to ablate neoplasms of the prostate.
16028077|NCT02680522|Other|Exercise|exercise training with virtual reality in videogame
16028078|NCT02680509|Procedure|Sympathicotomy R3|sympathicotomy R3 consists of transecting the sympathetic chain at the third costal level, cranial of the ganglia, leaving the ganglia themselves untouched
16028079|NCT02680496|Device|Lokomat|A single walking trial in which the patient walks in the Lokomat with 60% guidance force for 30 minutes at comfortable walking speed (body-weight supported if necessary)
16028080|NCT02680496|Other|Treadmill|A single walking trial in which the patient walks on a treadmill for 30 minutes at comfortable walking speed (body-weight supported if necessary)
16028081|NCT02680496|Other|Overground|A single walking trial in which the patient walks overground for 30 minutes at comfortable walking speed (body-weight supported if necessary)
16028082|NCT02680470|Device|Virtual observed therapy|Virtual Observation of participants taking their medication
16028083|NCT02680457|Drug|Insulin Degludec|Insulin Degludec 10 IU SC every 24 hours for 6 days
16028084|NCT02680457|Drug|Insulin Glargine|Insulin Glargine 10 IU SC every 24 hours for 6 days
16028085|NCT02680444|Behavioral|Self-Administered Mindful-Reappraisal Exercise|Combining the practice of mindful acceptance of negative events combined with a reappraisal of the event by examining its positive aspects.
16028086|NCT02680444|Behavioral|Self-Administered Reappraisal-Only Exercise|A reappraisal of daily negative events by examining the positive aspects.
16028087|NCT02680444|Behavioral|Self-Administered Event Recall Exercise|Recall a negative event that took place that day.
16028088|NCT02680431|Other|Blood sample|10 mL venous blood sample for analysis of plasma
16028089|NCT02680418|Drug|FDL169|
16028090|NCT02680405|Procedure|Skin Biopsy|Full thickness skin biopsies will be collected from each subject used for proteomic and genomic analysis of associated biomarker levels.
16028091|NCT02680405|Procedure|Skin tape stripping|Skin tape stripping used for proteomic and genomic analysis of associated biomarker levels.
16028092|NCT02680405|Procedure|Blood draw|Whole blood and serum testing used for proteomic and genomic analysis of associated biomarker levels.
16028093|NCT02680392|Procedure|Pulsed and Continuous Radiofrequency|"Preoperative pulsed radiofrequency of the saphenous nerve and Continuous radiofrequency of the genicular nerves of the knee joint.
~The saphenous nerve will be approached at the adductor canal and it will be treated with Pulsed RF for 4 minutes at 42 Celsius degrees. Ropivacaine 0.5% 10ml with Dexamethasone 10mg will be injected after the RF.
~The Genicular terminal branches of the sciatic and femoral nerves will be treated with Continuous RF for 3 min at 80 Celsius degrees and then with 2 ml of Ropivacaine 0.5% and 10 mg of Methylprednisolone to each nerve (5 in total) A sham catheter in the mid-thigh will be placed for patients in the RF group, infusing Normal Saline 0.9% and simulating a Continuous Adductor Canal Block. To blind the investigator to the type of treatment for the postoperative assessment , every solution bag will be prepared by the Pharmacy of the Hospital, covered with a plastic envelope and labeled as Study Solution."
16028094|NCT02680392|Drug|Continuous Adductor Canal Block|"The patients in the Adductor canal group, will have a catheter for peripheral nerve block inserted under strict asepsis in the adductor canal under ultrasound guidance, and will receive for postoperative analgesia a 48-h continuous infusion of Ropivacaine 0.2% at 8 ml/hour The patients will receive, intraoperatively 10 mg of Dexamethasone i.v.
~To blind the investigator who will do the postoperative assessment to the type of treatment, every solution bag will be prepared by the Pharmacy of the Hospital, covered with a plastic envelope and labeled as Study Solution. It will be always possible to crack the code and find out to which group the patient belongs"
16028095|NCT02680379|Drug|Minocycline, then Minocycline/Lovastatin|Participants of this group will take 1 tablet of minocycline 50mg daily for 4 weeks, minocycline 100mg for the following 4 weeks and finally a combined treatment of minocycline 100 mg and lovastatin 40mg for the following 12 weeks.
16028096|NCT02680379|Drug|Lovastatin, then Minocycline/Lovastatin|Participants of this group will take 1 tablet of lovastatin 20 mg daily for 4 weeks, lovastatin 40 mg for the following 4 weeks and finally a combined treatment of minocycline 100 mg and lovastatin 40 mg for the following 12 weeks.
16028097|NCT02680366|Device|collagen/ABMNC scaffold|The patients will receive a bone marrow puncture to collect bone marrow cells which are used to isolation of ABMNCs. After that, hysteroscopic adhesiolysis will be done according to the patient's uterine adhesion. Then, the collagen/ABMNCs scaffold was covered on a Foley catheter balloon and placed into the uterine cavity. The catheter balloon was kept for 24 hours and then removed. Oral antibiotics were given to prevent infection in the second and third days after operation. 72 hours after the surgery, a vaginal speculum examinations will be done in order to make patients unknown about their arms. Estrogen will be administrated for 3 cycles to support the endometrial regeneration after the surgery. The clinical follow up will be done at 1, 3 and 6 months after the procedure.
16028098|NCT02680366|Device|Foley catheter balloon|The patients will receive a sham bone marrow puncture which just has a local anesthesia and collects no bone marrow cells to isolation. After that, hysteroscopic adhesiolysis will be done according to the patient's uterine adhesion. And then, a Foley catheter balloon will be placed into the uterine cavity and kept for 72 hours before it is removed. Oral antibiotics were given to prevent infection in the second and third days after operation. Estrogen will be administrated for 3 cycles to support the endometrial regeneration after the surgery. The clinical follow up will be done at 1, 3 and 6 months after the procedure.
16028430|NCT02677922|Drug|Azacitidine|
16028099|NCT02680353|Procedure|Bilateral superficial cervical plexus block|A kind of anesthetic nerve block type performed to block the nerve function temporarily by administrating local anesthetics through the trajectory of the nerve.
16028100|NCT02680340|Procedure|Total Hip Arthroplasty|Patients who had a primary THA between 2002 and 2005
16028101|NCT02680314|Drug|Misoprostol|Misoprostol, a prostaglandin, binds to myometrial cells to cause strong myometrial contractions leading to expulsion of tissue. This agent also causes cervical ripening with softening and dilation of the cervix.
16028102|NCT02680301|Drug|0.1% triamcinolone CREAM|Patients will be asked to apply a topical steroid in a cream formulation to one extremity using the wet wrap technique.
16028103|NCT02680301|Drug|0.1% triamcinolone OINTMENT|Patients will be asked to apply a topical steroid in a ointment formulation to one extremity using the wet wrap technique.
16028104|NCT02680288|Drug|Lorcaserin, 10 mg|Oral type 2C serotonergic agonist, low-dose
16028105|NCT02680288|Drug|Lorcaserin, 20 mg|Oral type 2C serotonergic agonist, high-dose
16028106|NCT02680288|Other|Oral Placebo|Oral inert treatment
16028107|NCT02680275|Drug|Dead Sea Peloid Gel|intravaginally
16028108|NCT02680262|Behavioral|HPV self-sampling kit mailed directly|Women in intervention group 1 will be mailed a modified second reminder, a leaflet entitled Information about HPV self-sampling, and a self-sampling kit. The leaflet provides information about HPV and cervical cancer including benefits and harms about HPV self-sampling compared to regular screening. The kit includes a brush device (Evelyn Brush, Rovers Medical Devices B.V, Oss, Netherlands) to collect a cervico-vaginal sample for subsequent hrHPV testing, written and drawn instructions on how to obtain and mail the sample, and a pre-stamped return envelope addressed to the Department of Pathology, Randers Regional Hospital performing the hrHPV testing.
16028109|NCT02680262|Behavioral|HPV self-sampling kit on demand|"Women in intervention group 2 receive the same material as arm 1, except for the kit, which will only be mailed to the women on demand. Additionally, the leaflet for this group contains information on how to order the kit.
~The modified second reminder in both intervention groups informs of the opportunity to collect a self-sample if wanted, but also about the opportunity to have a conventional specimen taken at a general practitioner (usual procedure)."
16028110|NCT02680262|Behavioral|Second reminder|The standard second reminder informs women about the ongoing opportunity to have a conventional cervical sample taken by a general practitioner. (control group)
16028111|NCT02680249|Drug|CTP-656|
16028112|NCT02680236|Other|Art Therapy Group|"Patients fulfilling the inclusion criteria will be made an appointment with the art therapist for the Initial Assessment session. They will be given the following Reflect Interview session Final interview session An analgesic use form will be given to the patient to take home to note their actual analgesic use
~At the end of each of these art therapy sessions, patients will be given a Brief Pain Inventory form (BPI) with a stamped addressed envelope. This is to be completed twenty four hours after the appointment and returned by post."
16028113|NCT02680223|Device|Precision tinted lenses|Tinted lens for patient with reading difficulty or visual stress
16028114|NCT02680223|Device|Non-beneficial tinted lenses|Tinted lenses that are unlikely to help reading difficulty or visual stress
16028115|NCT02680210|Other|Questionnaires and cognitive measures|
16028116|NCT02680197|Drug|CHF5259 or Placebo administration|Administration of 2 puffs of treatment in the morning and in the evening during a 4 week period. Each patient will be allocated to 3 out of the 5 possible treatments.
16028117|NCT02680184|Drug|CMP-001|CMP-001 will be administered as per the dose and schedule specified in the respective arms.
16028118|NCT02680184|Drug|Pembrolizumab|Pembrolizumab will be administered as per the schedule specified in the respective arms.
16028119|NCT02680171|Behavioral|Prism Goggles|Patients in the experimental condition will wear prism goggles while completing a computerized aiming task. This prisms will shift the patients' vision 10 degrees rightward, causing a recalibration of visuo-motor information. Prism adaptation will be carried out over several days.
16028120|NCT02680171|Other|Non-Shifting Goggles|Non-shifting goggles are worn instead of prism goggles, while completing the same computerized aiming task as those assigned to the prism adaptation.
16028121|NCT02680158|Device|Oculeve Intranasal|Oculeve device, intranasal (test) application for approximately 3 minutes.
16028122|NCT02680158|Device|Sham|Sham device (control), intranasal application for approximately 3 minutes.
16028123|NCT02680158|Device|Oculeve Extranasal|Oculeve device, extranasal (control) application for approximately 3 minutes.
16028124|NCT02680145|Device|Preoperative Pessary Use|Pessary use for 1-4 weeks prior to surgical prolapse repair
16028125|NCT02680132|Drug|Nexium 40 mg DR Capsules of AstraZeneca LP, USA|oral, cross over
16028126|NCT02680132|Drug|Torrent's Esomeprazole Magnesium DR Capsules 40 mg|oral, cross over
16028127|NCT02680119|Drug|Nexium 40 mg DR Capsules of AstraZeneca LP, USA.|oral, crossover
16028128|NCT02680119|Drug|Torrent's Esomeprazole Magnesium DR Capsules 40 mg|oral, crossover
16028129|NCT02680106|Device|SPINNER|The SPINNER device is aimed at the DSW from a distance of 20 cm and activated for 1 minute. A nano-fibrous dressing is thus created.
16028130|NCT02680106|Device|JELONET|The patient's DSW will be dressed by JELONET
16028131|NCT02680093|Other|Cervical length in pregnant women.|"Pregnant Women beyond the date of birth. will be followed while coming to routine monitoring. physiological parameter of cervical length will be measured as the differential predictor to determine their due date. the cervical length will be measured as part of routine gynecologic examination to women who come for routine over due date follow up.
~additional medical data will be collected from the patient medical record.- demographic data, and all the routine prenatal medical care the women will receive up to the delivery.and delivery out comes."
16028132|NCT02680080|Drug|Moxifloxacin|a single 400 mg tablet of Moxifloxacin
16028133|NCT02680080|Dietary Supplement|Grapefruit group|one liter of fresh pink-grapefruit juice
16028134|NCT02680067|Drug|Indocyanine Green|A trained physician will inject 0.1 ml of Indocyanine Green into the web spaces of the hands in both upper extremities. Subjects may have up to five study visits to confirm feasibility, safety, and reproducibility.
16028135|NCT02680067|Device|MultiSpectral Imaging System|Once the Indocyanine Green is injected, the contrast is expected to fluoresce underneath the MultiSpectral Imaging System. Multispectral video and still images will be recorded at the study visits.
16028431|NCT02677922|Drug|AG-221|
16028136|NCT02680054|Drug|Insulin, Asp(B28)-|This insulin dose is sometimes given for fat and protein content of food in children using insulin pumps, in prolonged boluses. The investigators are replicating this in children using multiple insulin injections at various times related to the meal
16028137|NCT02680041|Drug|18F-fluciclovine PET CT|Subjects will undergo a fluciclovine F18 PET/CT scan in addition to standard of care monitoring. The results of this scan may influence further treatment
16028138|NCT02680028|Device|targon pft nail|220 mm vs 175mm nail
16028139|NCT02680015|Behavioral|PEERS|Social-behavioral intervention designed to help individuals with Autism Spectrum Disorder make and keep friends.
16028140|NCT02680002|Biological|7.5 mcg H5N1 (stored as monobulk)|
16028141|NCT02680002|Biological|15 mcg H5N1 (stored as monobulk)|
16028142|NCT02680002|Biological|90 mcg H5N1 (stored as monobulk)|
16028143|NCT02680002|Biological|90 mcg H5N1 (stored in vials)|
16028144|NCT02680002|Other|MF59|
16028145|NCT02680002|Other|MF59 (stored as monobulk)|
16028146|NCT02679989|Behavioral|Intermittent Energy Restriction|Dietary advice to follow 5:2 diet supported by physical activity advice and motivational group support sessions
16028147|NCT02679989|Behavioral|Continuous Energy Restriction|Dietary advice to follow daily energy restricted diet supported by physical activity advice and motivational group support sessions
16028148|NCT02679976|Device|etafilcon A|Marketed Multifocal Contact Lens
16028149|NCT02679963|Drug|Olaparib|
16028150|NCT02679963|Drug|Placebo|
16028151|NCT02679950|Genetic|Next generation genome sequencing|DNA will be extracted from each sample and assayed.
16028152|NCT02679937|Behavioral|Fit4Duty|Small (<9) participant-driven groups meet weekly for 6, 1 hour sessions. Participants design small, gradual healthy lifestyle change plans with added verbal, written, and behavioral exercises designed to elicit dissonance regarding engaging in unhealthy eating and sedentary practices. Participants are asked to voluntarily discuss the health, interpersonal and societal costs of obesity, an unhealthy diet, and sedentary behavior, as well as the benefits of leanness, a healthy diet, and regular physical activity.
16028153|NCT02679937|Other|Nutrition Education|Two, 50 minute educational videos address basic concepts of healthy nutrition and weight management reviewing topics such as macro and micronutrients, the virtue of whole grains, fruit, vegetables and superfoods, the dangers of dehydration and vitamin deficiency. The role of poor eating habits, lack of exercise and cultural and technological issues in America's obesity epidemic is examined. A basic understanding of energy balance is conveyed. The role of nutritional supplements is addressed.
16028154|NCT02679924|Device|Hyaluronic Acid filler|The objective of this study is to determine the efficacy and safety of Restylane® Silk Hyaluronic Acid filler microinjections when used in a grid-like injection pattern for the correction of fine lines to the cheeks.
16028155|NCT02679924|Other|Sham Comparator|Micro-injections of normal saline for correction of mid to low cheek fine lines and wrinkles.
16028156|NCT02679911|Drug|Loceryl NL|Topical over the entire toenail plate of all affected toenails, once weekly in the evening (at bed time) after filing down the affected toenails.
16028157|NCT02679911|Drug|Ciclopirox NL|Topical over the entire toenail plate of all affected toenails and surrounding skin, once daily in the evening (at bed time) after removing the free toenail edge and diseased toenails if needed
16028158|NCT02679898|Other|Unloaded-Whole Body Vibration (WBVT)|The unloaded-WBVT intervention consists of four leg exercises performed dynamically over a vibrating platform 3 times/week for 6 weeks. Dynamic movements were performed with controlled movements starting from an upright position into a 90 and 120 degree knee angle, wide-stance squat, and maximal heel elevation. The training volume increased progressively by increasing the intensity of the vibration (30-35 Hz; low-high amplitude), duration of exercise (30-60 sec), number of sets per exercise (2-8), and total during of training session, while decreasing the rest periods (60-30 sec).
16028159|NCT02679898|Other|Loaded-Whole Body Vibration (WBVT)|The loaded-WBVT intervention consists of four leg exercises performed dynamically over a vibrating platform 3 times/week for 6 weeks. Importantly, an external load was applied to a weight vest to account for the necessary weight to perform a specific number of repetitions (progressed from 15-8 repetitions maximum during the 6 weeks). Dynamic movements were performed with controlled movements starting from an upright position into a 90 and 120 degree knee angle, wide-stance squat, and maximal heel elevation. The training volume increased progressively by increasing the intensity of the vibration (30-35 Hz; low-high amplitude), duration of exercise (30-60 sec), number of sets per exercise (2-8), and total during of training session, while decreasing the rest periods (60-30 sec).
16028160|NCT02679859|Other|BNP guided medical therapy optimisation|
16028161|NCT02679846|Other|Standardized protocol|The standardized protocol of AEDs withdrawal will be implemented and applied to all inpatients
16028162|NCT02679833|Dietary Supplement|Placebo|Toothpaste not containing the vitamin.
16028163|NCT02679833|Dietary Supplement|Cyanocobalamin|Toothpaste containing100 µg cyanocobalamin/g.
16028164|NCT02679820|Device|Copper T intrauterine device|
16028165|NCT02679807|Biological|Bifidobacterium animalis subsp. lactis Bl-04|
16028166|NCT02679807|Other|sucrose|
16028167|NCT02679794|Behavioral|Egg consumption|Subjects will consume a carefully portioned sautéed vegetables and 3g canola oil with 100g (2 large eggs) of whole eggs
16028168|NCT02679794|Behavioral|Control|Subjects will consume a carefully portioned sautéed vegetables and 3g canola oil.
16028169|NCT02679781|Drug|oral midazolam|administration of 0.5mg/kg oral midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
16028170|NCT02679781|Drug|nasal midazolam|administration of 0.2mg/kg nasal midazolam. During dental treatment 50% nitrous oxide/ 50% oxygen will be administered via nasal hood.
16028171|NCT02679768|Behavioral|Circadian Reinforcement Therapy|Circadian reinforcement therapy plus electronical monitoring. Circadian reinforcement therapy is a specialized psychoeducation working with strengthening of circadian rhythms.
16028172|NCT02679768|Behavioral|Standard treatment|Standard treatment plus electronical monitoring
16028173|NCT02679755|Drug|Palbociclib|125 mg/d capsules orally for 3 out of 4 weeks in repeated cycles
16028174|NCT02679755|Drug|Letrozole|2.5 mg/d tablets orally on a continuous regimen
16028432|NCT02677909|Device|AEGIS (Automated Evaluation of Gastrointestinal Symptoms)|Will place device on admission to SICU. Measure bowel sounds and await bowel function
16028175|NCT02679742|Dietary Supplement|β-hydroxymethylbutyrate|β-hydroxymethylbutyrate 3 grams once a day combined with a resistance training program (3 progressive resistance training sessions per week) during 12 weeks
16028176|NCT02679742|Dietary Supplement|Placebo|Maltodextrin 3 grams once a day combined with a resistance training program (3 progressive resistance training sessions per week) during 12 weeks
16028177|NCT02679729|Drug|AZD5634 for inhalation|Solution, citrate buffer, saline nebulizer solution; strength 0.1 - 5 mg/g; administered by jet nebulizer
16028178|NCT02679729|Drug|AZD5634 for infusion|Solution, citrate buffer, saline solution for infusion; strength 0.013 mg/mL
16028179|NCT02679729|Other|Placebo|inactive substance
16028180|NCT02679716|Other|MRI of the cerebral arteries|MRI of the cerebral arteries is performed
16028181|NCT02679703|Device|High voltage|Electrical stimulation treatments will be made in donor areas (scalp and thigh) in patients burns
16028182|NCT02679703|Device|Neuromuscular transcutaneous electrical stimulation (TENS)|Electrical stimulation treatments will be made in donor areas (scalp and thigh) in patients burns.
16028183|NCT02679703|Other|Control Group|The control group will not have electrical stimulation however, will be evaluated with digital digital imaging, thermography imaging, skin hardness and subjective pain and healing scales
16028184|NCT02679690|Behavioral|Standard Dietary Sodium Education|Standard dietary education for sodium restricted diets for patients with heart failure.
16028185|NCT02679690|Behavioral|Color-Coded Cue Cards|The use of a color-coded cue card to designate ranges of acceptable sodium content of food for comparison to labels while grocery shopping.
16028186|NCT02679677|Device|Whole Body Vibration|The principle of the Galileo vibration platform is a side alternating motion similar to a childrens seesaw. Both the amplitude of movement and the frequency of movement may be altered. Frequency may be controlled on the device and settings range from 5Hz to 30Hz. Amplitude of movement is set by spreading one's legs further apart from the midline. Control arm participants remain fixed at 5Hz through the 6 week training period, while intervention arm participants steadily increase their frequency to a maximum of 28Hz.
16028187|NCT02679664|Drug|Rosuvastatin|20 mg tablet of rosuvastatin
16028188|NCT02679651|Other|Ultrasound of the foot|An ultrasound will be used to determine the thickness of the fat pad
16028189|NCT02679651|Other|Pedobarograph Measurements|This non-invasive device measures the force and pressure of the foot while standing and walking.
16028190|NCT02679651|Other|Manchester Foot Pain and Disability Index|This is a patient completed questionnaire that assesses level of function from the past month specific to foot pain.
16028191|NCT02679638|Other|Factors and perceptions questionnaire|A detailed questionnaire inquiring about demand factors, supply factors and perceptions affecting patients' treatment choices in 5 key decision points: participation role in the decision making process, hospital choice, treatment regimen choice, surgical extent and surgeon choice.
16028192|NCT02679638|Other|Qualitative interview|Depth interviews with 20 breast cancer patients, 2 spouses and 3 staff members.
16028193|NCT02679625|Device|Ultrasound and NICOM|All patients enrolled will have all three ultrasound-based modalities for fluid responsiveness performed, as well as have NICOM data to serve as the comparison standard.
16028194|NCT02679599|Other|B-MOBILE-CARDIAC smartphone application|
16028195|NCT02679599|Behavioral|Cardiac rehabilitation as usual|
16028196|NCT02679586|Device|Diffusion weighted MRI|
16028197|NCT02679573|Drug|Delafloxacin|Antibacterial agent, 300 mg IV, Q12H for at least 6 doses with potential to switch to 450 mg oral tablet, Q12H for up to 20 doses total
16028198|NCT02679573|Drug|Moxifloxacin|Antibacterial Agent, 400 mg IV, Q24H for at least 3 doses with potential to switch to 400 mg oral over-encapsulated tablet, Q24H for up to 10 doses total
16028199|NCT02679573|Drug|Linezolid|Antibacterial Agent, at local investigator discretion, subjects in the moxifloxacin arm with confirmed MRSA can switch to linezolid 600 mg IV Q12H for all remaining doses
16028200|NCT02679560|Drug|Liposomal Bupivacaine|A fascia iliaca compartment block using liposomal bupivacaine will require less total opioid administration compared to a fascia iliaca block using 0.2% ropivacaine
16028201|NCT02679560|Drug|Ropivacaine HCL|Ropivacaine HCL is a member of the amino amide class of local anesthetics. Naropin injection is a sterile, isotonic solution that contains the enantiomerically pure drug substance, sodium chloride for isotonicity and water for injection. It is administered parenterally.
16028202|NCT02679547|Other|Breastfeeding|All of the participants and patients will have a questionnaire about their breastfeeding
16028203|NCT02679534|Other|hand massage|
16028204|NCT02679534|Other|hand holding|
16028205|NCT02679534|Other|application of unscented hypoallergenic cream|
16028206|NCT02679534|Other|environmental adjustments|
16028207|NCT02679521|Device|ESWT|"Radial extracorporeal shock wave therapy (rESWT) was performed by the principal investigator with a Swiss DolorClast device (EMS Electro Medical Systems Corporation; Dallas, Texas, USA).
~The Swiss DolorClast device obtained Pre-Market Approval (PMA) by FDA as Class III orthopedic lithotripsy device to treat heel pain associated with chronic proximal plantar fasciitis on May 8, 2007 (PMA # P050004), and was re-classified as Class III Generator, Shock Wave, For Pain Relief (Product Code NBN) in the Spring 2009. The present study started on October 3, 2007.
~Each patient received two sessions of rESWT one week apart, with 2,000 impulses per session (air pressure of the device set at 3.5 bar; impulses applied with the 15 mm applicator at frequency of 8 Hz)."
16028208|NCT02679521|Device|Placebo|Placebo treatment was performed identically as rESWT but with a clasp on the heel that prevented transmission of the impulses from the applicator to the skin at the treatment site.
16028209|NCT02679508|Drug|Vonoprazan|Vonoprazan fumarate 10 mg or 20 mg capsules
16028210|NCT02679508|Drug|Lansoprazole|Lansoprazole 15 mg or 30 mg capsules
16028211|NCT02679495|Behavioral|Active measures of lifestyle modification|
16028212|NCT02679469|Drug|nalmefene hydrochloride 10 mg|
16028213|NCT02679456|Drug|SCY-078|
16028214|NCT02679456|Drug|Fluconazole|
16028215|NCT02679443|Dietary Supplement|Folate and B12|Vitamin (folate and B12) supplementation started simultaneously with initiation of chemotherapy (within 24 hours of initiation of chemotherapy). The only difference from the delayed (no-intervention) arm is the timing of initiation of vitamin supplementation. Dose and mode of administration of vitamin B12 and folate supplementation remain similar in both arms.
16028216|NCT02679430|Device|Prostate Arterial Embolization|The purpose of this study is to demonstrate the safety and efficacy of the device, Embosphere Microspheres, in prostatic arterial embolization (PAE). PAE, is now an accepted form of treatment for BPH outside of the United States, however few studies have been performed demonstrating safety and efficacy in the US. Embosphere Microsphere is a device that may be used to reduce blood flow to targeted organs. With this research, we would like to show that Embosphere Microsphere may be used for patients with benign hyperplasia of prostate (BPH to reduce blood flow to the prostate gland. This current study is designed to understand the rate of improved BPH symptoms.
16028217|NCT02679417|Behavioral|exercise|12 weeks of aerobic or resistant exercise
16028218|NCT02679378|Device|ClearSight™ System|comparing ClearSight system to histopathological to determine negative-margins in breast conserving surgery.
16028219|NCT02679365|Procedure|lower segment cesarean section and double lock closure of rectus sheath|
16028220|NCT02679365|Procedure|lower segment cesarean section and continuous non-locking closure of rectus sheath|
16028221|NCT02679352|Device|SMR Stemless|Total anatomic or reverse shoulder arthroplasty
16028222|NCT02679339|Drug|CNTX-2022 (lidocaine gel, 40%)|
16028223|NCT02679339|Drug|Placebo|
16028224|NCT02679326|Device|Therapeutic ultrasound|
16028225|NCT02679313|Device|Phoropter|Each subject will be tested on 3 separate occasions using either the manual phoropter (American Optical 11625), electronic phoropter (Topcon CV-5000) or the wearable adaptive refractor (VisionFit). Oculomotor measurements, i.e., heterophoria, vergence ranges, AC/A and accommodative findings will be measured at each session using the different devices. Each session will be separated by a minimum of 24 hours and a maximum of 14 days.
16028226|NCT02679300|Other|Virtual reality exercise group|
16028227|NCT02679300|Other|Conventional exercise group (control group)|
16028228|NCT02679287|Device|CLC|The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.
16028229|NCT02679274|Drug|Placebo|Intermittent intramuscular injections of saline (males and females).
16028230|NCT02679274|Drug|Testosterone|Intermittent intramuscular injections of 100 mg Testosterone Enanthate (males) or 25 mg Testosterone Enanthate (females).
16028231|NCT02679261|Drug|Atorvastatin|Oral administration atorvastatin 20 mg per day
16028232|NCT02679261|Drug|Placebo|Oral administration placebo
16028233|NCT02679248|Dietary Supplement|Neo40 Daily®|
16028234|NCT02679248|Dietary Supplement|Placebo|
16028235|NCT02679235|Drug|POST Triheptanoin|The target daily dose of triheptanoin will be 1 g/kg/d, or approximately 70 g/d during 28±2 days. It will be divided into four daily doses, one of which will be consumed at each meal and one with an evening snack.
16028236|NCT02679222|Dietary Supplement|Coconut oil|20 g of coconut oil
16028237|NCT02679222|Dietary Supplement|Coconut oil + MCT|10 g of coconut oil + 10 g of MCT (60 of C8 + 40 of C10)
16028238|NCT02679222|Dietary Supplement|MCT|20 g of MCT (60 of C8+40 of C10)
16028239|NCT02679222|Dietary Supplement|Coconut oil + tricaprylin|10 g coconut oil + 10 g tricaprylin
16028240|NCT02679222|Dietary Supplement|Tricaprylin|20 g tricaprylin
16028241|NCT02679222|Dietary Supplement|Tricaprin|20 g tricaprin
16028242|NCT02679222|Dietary Supplement|Control|No supplement taken on this visit
16028243|NCT02679209|Biological|Demineralized bone matrix in putty form|it is a type of bone graft from human cadavers.
16028244|NCT02679209|Biological|Amnion chorion membrane|A bioresorbable allograft membrane for guided tissue regeneration from amnion and chorion parts of the placenta from pregnant females for guided tissue regeneration.
16028245|NCT02679196|Drug|KA2237|PI3 Kinase p110β/δ inhibitor
16028246|NCT02679183|Dietary Supplement|Medically-Graded Honey|Honey added to the baby formula once a day for 2 weeks.
16028247|NCT02679183|Other|Premature Milk Formula|Enteral feeds were provided to subjects of all groups using premature milk formula as per routine nutritional management in the neonatal intensive care unit.
16028248|NCT02679170|Drug|Crizotinib|Treatment with crizotinib following routine clinical practice
16028249|NCT02679144|Drug|Difluoromethylornithine (DFMO)|Subjects will receive 730 Days of oral difluoromethylornithine (DFMO) at a dose of 750 mg/m2 ± 250 mg/m2 BID (strata 1, 2, 3, and 4) OR 2500 mg/m2 BID (stratum 1B) on each day of study.
16028250|NCT02679131|Drug|Belinostat|Belinostat will be administered once daily on days 1 to 5 of a 21-day cycle (up to 6 cycles) via 30-min. IV infusion.
16028251|NCT02679118|Device|Sentire|The device, at predetermined time points, will draw a small amount of gas from the abdomen. Upon obtaining the samples, the machine will analyze the sample for evidence of bowel gas. After each sample, the device will be purged prior to the acquisition of the next gas sample. The results of the analysis of the gas samples will be recorded for future analysis.
16028252|NCT02679105|Drug|ALK Alutard birch or 5-grasses|3 injections with 4-5 weeks interval.
16028253|NCT02679105|Drug|ALK diluent|0,3% human albumin
16028254|NCT02679092|Drug|Misoprostol|400 mcg buccal 60-90 minutes prior to procedure
16028255|NCT02679092|Drug|Mifepristone|200 mg PO on the day prior to D&E
16028256|NCT02679092|Device|Hygroscopic cervical dilators|osmotic cervical dilators inserted through the internal os
16028257|NCT02679079|Drug|NBI-98854|
16028258|NCT02679079|Drug|Placebo|
16028259|NCT02679066|Device|Sugar-tong splint|Plaster immobilization including the elbow
16028260|NCT02679066|Device|Short forearm cast|Fiberglass immobilization with elbow free
16028261|NCT02679053|Behavioral|Aerobic exercise|
16028262|NCT02679053|Behavioral|Placebo control|
16028263|NCT02679040|Procedure|Immediate mammary reconstruction|Chemotherapy administration then radiotherapy and then surgery : mastectomy and immediate mammary reconstruction.
16028264|NCT02679040|Drug|Chemotherapy|Chemotherapy treatment
16028265|NCT02679040|Radiation|Radiation therapy|Radiation therapy
16028266|NCT02679027|Other|Protrude tongue maximally and upward (PTMU)|The horizontal line was passing through the mid points of the distance between subnasale to stomion (upper lip height). Patients were asked to protrude tongue maximally and upward (PTMU).
16028433|NCT02677896|Drug|Enzalutamide|Oral
16028434|NCT02677896|Drug|Placebo|Oral
16028267|NCT02679027|Other|Protrude tongue maximally and downward (PTMD)|The horizontal line was passing through the mid points of the distance between stomion to mentum (mandible height). Patients were asked to protrude tongue maximally and downward (PTMD).
16028268|NCT02679014|Drug|Placebo|With the exception of the mornings of Days 7 and 21, placebo capsules will be taken orally with a glass of still water in the morning and evening under fed conditions. On the mornings of Days 7 and 21, placebo will be administered under fasted conditions (overnight fast of at least 8 hours before dosing).
16028269|NCT02679014|Drug|RO5459072|With the exception of the mornings of Days 7 and 21, RO5459072 capsules will be taken orally with a glass of still water in the morning and evening under fed conditions. On the mornings of Days 7 and 21, RO5459072 will be administered under fasted conditions (overnight fast of at least 8 hours before dosing).
16028270|NCT02679001|Drug|TNF inhibitor/TCZ|Participants with RA receiving TNF-inhibitor or TCZ according to standard of care and in line with the current SPC/local labeling will be observed.
16028271|NCT02678988|Device|AI-1000 G2|The device will contain TCZ (180 milligrams per milliliter [mg/mL]) SC formulation single dose of 0.9 mL that corresponds to 162 mg TCZ administered via PFS and assembled in the AI (AI-1000 G2).
16028272|NCT02678988|Device|PFS-NSD|The device will contain TCZ (180 mg/mL) SC formulation single dose of 0.9 mL that corresponds to 162 mg TCZ administered via PFS-NSD.
16028273|NCT02678988|Drug|Tocilizumab|Participants will receive two single doses of 162 mg tocilizumab SC on Day 1 (Period 1) and Day 43 (Period 2), with a washout period of 6 weeks between the periods.
16028274|NCT02678975|Drug|Disulfiram|Disulfiram 400 mg daily
16028275|NCT02678975|Dietary Supplement|Copper|nutritional supplement with copper, 2 mg daily
16028276|NCT02678975|Drug|Alkylating Agents|Alkylating antineoplastic agent
16028277|NCT02678962|Device|SN6AD1|Bilateral cataract surgery with implantation of SN6AD1 multifocal IOLs
16028278|NCT02678962|Device|SBL-3|Bilateral cataract surgery with implantation of SBL-3 multifocal IOLs
16028279|NCT02678962|Device|LS-313 MF30|Bilateral cataract surgery with implantation of LS-313 MF30 multifocal IOLs
16028280|NCT02678962|Device|AT LISA tri 839 MP|Bilateral cataract surgery with implantation of AT LISA tri 839 MP multifocal IOLs
16028281|NCT02678962|Device|ART|Bilateral cataract surgery with implantation of ART toric multifocal IOLs
16028282|NCT02678962|Device|LS-313 MF30T|Bilateral cataract surgery with implantation of LS-313 MF30T toric multifocal IOLs
16028283|NCT02678949|Drug|Inhaled Fluticasone 50 mcg/twice day|After 7 days washout period, patients with mild asthma (group 2) will come to visit 2 where carried out a baseline spirometry and MBW test, subsequently will indicate them start treatment with inhaled fluticasone 50 mcg/twice a day, for a period of 4 weeks. At the end of the 4 weeks of treatment patients will come to Visit 3 and perform again spirometry and MBW test.
16028284|NCT02678949|Drug|Inhaled Fluticasone 100 mcg/twice day|After 7 days washout period, patients with moderate asthma (group 3) will come to visit 2 where carried out a baseline spirometry and MBW test, subsequently will indicate them start treatment with inhaled fluticasone of 100 mcg/twice a day, for 4 weeks period. At the end of the 4 weeks of treatment patients will come to Visit 3 and perform again spirometry and MBW test.
16028285|NCT02678949|Drug|Inhaled Albuterol|The patients in Group 2 and group 3 performing a baseline spirometry and MBW test, after which one dose of 400 mcg of inhaled albuterol will be administered. Twenty minutes after inhaling the dose of albuterol, spirometry and MBW test will be measured again in both groups.
16028286|NCT02678936|Biological|PRP|Application of platelet-rich plasma during surgery
16028287|NCT02678923|Drug|MDCO-216|
16028288|NCT02678923|Drug|Placebo|
16028289|NCT02678910|Procedure|Ovarian Cryopreservation|The ovarian tissue will be removed at a UK Healthcare facility and evaluated for gross disease by a pathologist, embryologist, andrologist or REI physician. The ovarian cortex will be dissected from the medulla and cut into strips in culture/holding media, washed to remove blood cells, and cryopreserved. Cryopreservation will be performed using modifications of the techniques described by Gosden et al. (1994) or will be vitrified using a modification of the techniques of Kuwayama et al., 2007.
16028290|NCT02678897|Drug|Oxynorm on-demand|"We compare different routes of administration (PCA an oral/intramuscular use of oxynorm) in patients undergoing medical termination of pregnancy. Patients are randomized in two groups (for extra pain medication)
~If analgesia is inadequate oxycodon (OxyNorm®) (10 mg (less than 80 kg) - 15 mg (over 80 kg) po. In an hour oxycodon 5-10 mg more po if needed. Intramuscular or intravenous administration if needed.
~Patient controlled analgesia (PCA pain pump): Oxycodon dose is 3.0 mg (3 ml) and lock-out time 8 min. Maximum four doses in hour. Dose can be lowered or augmented 0,5 mg at time between 2.0-4.0 mg and maximal number of doses can be up to 5."
16028291|NCT02678897|Drug|Oxynorm via PCA|"We compare different routes of administration (PCA an oral/intramuscular use of oxynorm) in patients undergoing medical termination of pregnancy. Patients are randomized in two groups (for extra pain medication)
~If analgesia is inadequate oxycodon (OxyNorm®) (10 mg (less than 80 kg) - 15 mg (over 80 kg) po. In an hour oxycodon 5-10 mg more po if needed. Intramuscular or intravenous administration if needed.
~Patient controlled analgesia (PCA pain pump): Oxycodon dose is 3.0 mg (3 ml) and lock-out time 8 min. Maximum four doses in hour. Dose can be lowered or augmented 0,5 mg at time between 2.0-4.0 mg and maximal number of doses can be up to 5."
16028292|NCT02678884|Drug|18-F FDG|All patients enrolled in this study will receive 2 PET Scans: One prior to Radiation, and one during Radiation.
16028293|NCT02678871|Device|Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations)|Patients meeting clinical and anatomical pre-requisites will undergo TAVI with the Lotus or ACURATE neo Heart valve system (or subsequent CE marked iterations)
16028294|NCT02678871|Device|WATCHMAN|LAA closure with the WATCHMAN device
16028295|NCT02678858|Behavioral|Integrated Social Cognitive and Behavioral Skills Therapy|The Integrated Social Cognitive and Behavioral Skills Therapy (ISST) is a newly developed treatment program. It is based on the Training of Affect Recognition (Wölwer et al. 2005) and common social skills trainings, which are combined in an integrated rather than a sequenced manner. ISST uses both repeated practice and strategy-based training, and consists of 12 individual sessions, 5 group sessions and 1 individual final session over a period of 6 months.
16028480|NCT02677558|Other|Transthoracic Echocardiography|Obese term pregnant women and term pregnant women of normal weight are both undergoing transthoracic echocardiography assessment to establish differences in cardiac function in pregnancy caused by obesity.
16028296|NCT02678858|Behavioral|Neurocognitive Remediation Therapy|The Neurocognitive Remediation Program (NCRT) is based on a neurocognitive training already used as active control condition in our earlier studies (Wölwer et al. 2005, Klingberg et al. 2011). The present version of NCRT is matched in dose, mode and scheme of application to the ISST, but differs from the ISST regarding targeted cognitive domains and preferred training strategy (predominantly drill and practice based). The NCRT provides the same amount of group interaction and companionship as well as the same amount of guided community activity as in the ISST, but is structured in such a way that interactional behavior is secondary (e.g. by competition-like tasks rather than cooperative tasks). Thus therapeutic attention and commitment are held constant across study conditions.
16028297|NCT02678845|Other|Treatment according to the Collabri model|The Collabri Model is a complex intervention and consists of a number of treatment modalities. The Collabri Model includes the following elements: A multi-professional approach to treatment including a care manager, scheduled monitoring and review, enhanced inter-professional communication and a structured treatment plan. It further integrates: Recruitment of staff with psychiatric experience, training of general practitioner and care manager, use of instruments for detection and follow-up, education and treatment of the patient, supervision from a psychiatric specialist, guided self-help, patient- and relative involvement and a stepped care approach to treatment where treatment is always commenced on the least invasive and least resource-demanding level.
16028298|NCT02678819|Device|Digital cognitive aid|Digital cognitive aid during anesthesia and intensive care crises.
16028299|NCT02678806|Radiation|Postoperative radiotherapy|The radiotherapy group received prophylactic radiotherapy 1 month after operation. All the patients in the experimental group were treated with 6 to 8 MV X-ray, intensity-modulated irradiation (IMRT) technique, which was divided into 4-5 fields, 2Gy/25 times. 5f/W, total dose 50Gy
16028300|NCT02678806|Drug|Postoperative TACE|In the intervention group, TACE was performed in January and March after operation. The femoral artery puncture was performed by Seldinger method, and the cannula was intubated to the hepatic artery by DSA. Then, 50 mg of lobaplatin plus 4 mg of raltitrexed was injected into the vascular artery. The embolic agent was selected as 38.0. % super liquefied iodine solution and / or gelatin sponge particles, the dose is maintained at 5 ~ 20ml. At the end of treatment, a DSA examination again confirmed that the tumor was completely occluded.
16028301|NCT02678793|Drug|CNTX-4975|
16028302|NCT02678780|Drug|Lenvatinib|
16028303|NCT02678767|Drug|Ferumoxytol|All subjects will receive neurocognitive testing. Subjects will have a brain MRI prior to drug infusion. A one-time ferumoxytol IV infusion will be given at a dose of 4mg Fe/kg up to a maximum of 510mg of elemental iron delivered at a rate of 1ml/sec. A second brain MRI will be completed post-infusion
16028304|NCT02678754|Other|No intervention required, purely observational|
16028305|NCT02678741|Drug|TLPLDC Vaccine|Tumor Lysate, Particle Loaded, Dendritic Cell Vaccine
16028306|NCT02678728|Drug|Dexmedetomidine|1ug/kg IV loading over 20 minutes followed by 0.5ug/kg/hr IV infusion until 12 hrs of aortic cross clamp off
16028307|NCT02678728|Drug|normal saline|IV loading and infusion of same volume of normal saline after induction until 12 hrs of aortic cross clamp off
16028308|NCT02678715|Device|Solubrux®|prefabricated device adaptable by temperature
16028309|NCT02678715|Device|Customized Appliance|customized device fabricated in the dental laboratory
16028310|NCT02678715|Device|Somatics®|standard device
16028311|NCT02678702|Behavioral|CBT-I|CBT-I
16028312|NCT02678702|Behavioral|Treatment as usual|Treatment as usual
16028315|NCT02678676|Other|No Intervention|Participants who previously received Pioglitazone in the PROactive study (NCT00174993).
16028316|NCT02678676|Other|No Intervention|Participants who previously received pioglitazone-matching placebo in the PROactive study (NCT00174993).
16028317|NCT02678663|Procedure|Injection-assisted Cold Snare Polypectomy|Resection of a polyp after blue-tinted saline injection using a cold snare (without application of electrocautery)
16028318|NCT02678663|Procedure|Endoscopic Mucosal Resection|Resection of a polyp after blue-tinted saline injection using snare electrocautery
16028319|NCT02678650|Drug|volatile anesthetics(isoflurane)|volatile anesthetics wash-in / wash-out operation
16028320|NCT02678650|Drug|propofol intravenous anesthesia|propofol infusion 3-5μg / kg / h
16028321|NCT02678637|Other|MRI and muscle dynamometer|
16028322|NCT02678624|Other|Treatment according to the Collabri model|The Collabri Model is a complex intervention and consists of a number of treatment modalities. The Collabri Model includes the following elements: A multi-professional approach to treatment including a care manager, scheduled monitoring and review, enhanced inter-professional communication and a structured treatment plan. It further integrates: Recruitment of staff with psychiatric experience, training of general practitioner and care manager, use of instruments for detection and follow-up, education and treatment of the patient, supervision from a psychiatric specialist, guided self-help, patient- and relative involvement and a stepped care approach to treatment where treatment is always commenced on the least invasive and least resource-demanding level.
16028323|NCT02678611|Dietary Supplement|Basis 250|
16028324|NCT02678611|Dietary Supplement|Basis 500|
16028325|NCT02678611|Dietary Supplement|Placebo|
16028326|NCT02678598|Drug|Micafungin|Intravenous
16028327|NCT02678585|Drug|Nalbuphine|53 patients received intravenous regional lidocaine plus nalbuphine
16028328|NCT02678585|Drug|Lidocaine|53 patients received intravenous regional lidocaine
16028329|NCT02678572|Combination Product|Melphalan/HDS|Melphalan (3 mg/kg IBW) with Hepatic Device System (HDS)
16028330|NCT02678559|Other|tee measurement|
16028331|NCT02678559|Other|flotrac measurement|
16028332|NCT02678559|Other|clearsight measurement|
16028333|NCT02678546|Other|Other|case review of diagnosed disease
16028334|NCT02678533|Drug|G-CSF|D1 to D4 : Injection of 12 µg/kg of G-CSF twice a day . D5 : injection of 12 µg/kg of G-CSF (once/ twice a day according to cytapheresis's realization)
16028335|NCT02678533|Drug|Plerixafor|D5 : injection of 24mg/kg of plerixafor once a day until cytapheresis has be done (maximum of 4 days)
16028336|NCT02678520|Radiation|3-D Conformal Radiation Therapy|"Radiation delivered after surgery to remove the prostate, using 3-D Conformal Radiation Therapy. Radiation will be delivered to prostatic fossa / surgical bed including any suspected regions of microscopic disease such as positive margins, extracapsular extension and/or seminal vesicle involvement.
~The total dose of radiation will be 6600 centigray (cGy) at 200 cGy/fraction (fx) given once daily ."
16028337|NCT02678520|Radiation|Intensity Modulated Radiation Therapy|"Radiation delivered after surgery to remove the prostate, using Intensity Modulated Radiation Therapy. Radiation will be delivered to prostatic fossa / surgical bed including any suspected regions of microscopic disease such as positive margins, extracapsular extension and/or seminal vesicle involvement.
~The total dose of radiation will be 6600 centigray (cGy) at 200 cGy/fraction (fx) given once daily ."
16028338|NCT02678520|Drug|Casodex, Zoladex , Lupron|"Hormonal Therapy (6 Months): Required for High Risk Groups, and as per Standard of Care for Low Risk Groups.
~Hormonal therapy protocol regimen for the high risk adjuvant and salvage groups will consist of Casodex (50 mg/day po for 6 months) and Zoladex (10.8 mg subcutaneously once every 3 months x 2) or Lupron (22.5 mg given intramuscularly once every 3 months x 2 injections or 7.5 mg IM q once monthly x 6) to start on day 1 of the clinical trial.
~Hormonal therapy will typically begin 2 months prior to radiation and continue for a total of 6 months."
16028339|NCT02678507|Other|Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)|
16028340|NCT02678494|Other|Neurofeedback training|
16028341|NCT02678481|Device|MR-guided in-bore prostate biopsy|2 targeted biopsy cores from each prostate lesion detected at multiparametric MR imaging
16028342|NCT02678481|Device|TRUS-guided prostate biopsy|24-28 systematic biopsy core (saturation scheme)
16028343|NCT02678455|Biological|TV005 vaccine|Delivered by subcutaneous injection; contains 10^3 PFU of rDEN1Δ30, 10^4 PFU of rDEN2/4Δ30(ME), 10^3 PFU of rDEN3Δ30/31, and 10^3 PFU of rDEN4Δ30.
16028344|NCT02678455|Biological|Placebo|Delivered by subcutaneous injection
16028345|NCT02678442|Device|Fine Needle Biopsy (FNB)|The Shark Core FNB is an FDA approved device for sampling of submucosal lesions, mediastinal masses, lymph nodes and intraperitoneal masses. FNB will be performed by 22 gauge for pancreas head and by 19 gauge for all the other sites.
16028346|NCT02678442|Device|Fine Needle Aspiration (FNA)|Fine needle aspiration is a type of biopsy procedure. In fine needle aspiration, a thin needle is inserted into an area of abnormal-appearing tissue or body fluid, and histological material is obtained. FNA will be performed with a standard 25g needle in the usual fashion using back and forth passes for 30 seconds.
16028347|NCT02678429|Device|Change DBS programming|Patient will change thier settings to move from one group to the other to trial the other DBS settings
16028348|NCT02678416|Drug|IV Acetaminophen (Treatment A)|Acetaminophen administered by intravenous (IV) infusion
16028349|NCT02678416|Drug|Oral Acetaminophen (Treatment B)|Acetaminophen administered by oral tablets
16028350|NCT02678416|Drug|Placebo (Treatment C)|Placebo administered by IV infusion or oral tablets
16028351|NCT02678416|Other|Morphine (Treatment D)|Morphine administered by IV infusion
16028352|NCT02678403|Device|Transcutaneous electrical nerve stimulation (TENS)|Transcutaneous electrical nerve stimulation (TENS) is the use of electric current produced by a device to stimulate the nerves that only induces sensory stimulation (without muscle contraction) and is classically used in the treatment of pain.
16028353|NCT02678403|Device|SHAM Transcutaneous electrical nerve stimulation (TENS)|Transcutaneous electrical nerve stimulation (TENS) is the use of electric current produced by a device to stimulate the nerves that only induces sensory stimulation (without muscle contraction) and is classically used in the treatment of pain.
16028354|NCT02678390|Dietary Supplement|MCT|A 5 day consecutive MCT intake of 30 g/day.
16028355|NCT02678390|Dietary Supplement|MCT+ aerobic exercise|A 5 day consecutive MCT intake of 30 g/day in combinaison with 30 minutes of aerobic exercise (70% to 80% HRR) per day for the five days.
16028356|NCT02678390|Dietary Supplement|Aerobic exercise|A single period of 30 minutes of aerobic exercise (70% to 80% HRR).
16028357|NCT02678390|Dietary Supplement|Control day|No MCT or aerobic exercise
16028358|NCT02678377|Drug|OnabotulinumtoxinA (Botox ®) Injections|OnabotulinumtoxinA (Botox ®) is a neurotoxin, which inhibits acetylcholine release and temporarily relaxes the bladder muscle to inhibit urgency incontinence.
16028359|NCT02678377|Drug|Saline Injections|Saline will be injected into the bladder so that investigators are masked to subject randomization.
16028360|NCT02678364|Dietary Supplement|Control eggs|Control eggs containing no additional vitamin D beyond norm
16028361|NCT02678364|Dietary Supplement|Vitamin D3 eggs|Vitamin D3-biofortified eggs
16028362|NCT02678364|Dietary Supplement|25-Hydroxyvitamin D3 eggs|25-Hydroxyvitamin D3-biofortified eggs
16028363|NCT02678351|Drug|gallium Ga 68-PSMA-11|Undergo gallium Ga 68-PSMA PET/MRI
16028364|NCT02678351|Procedure|Magnetic Resonance Imaging|Undergo gallium Ga 68-PSMA PET/MRI
16028365|NCT02678351|Procedure|Positron Emission Tomography|Undergo gallium Ga 68-PSMA PET/MRI
16028366|NCT02678338|Drug|Hu5F9-G4|
16028367|NCT02678325|Other|Standardized high protein enteral nutrition|A double-blind randomized controlled clinical trial of critically ill patients to explore values of high enteral protein administration on muscle breakdown and mortality.
16028368|NCT02678325|Other|Standardized normal protein enteral nutrition|double-blind randomized controlled clinical trial of critically ill patients to explore values of high enteral protein administration (compared to normal enteral protein administration) on muscle breakdown and mortality.
16028373|NCT02678299|Drug|PREBEN|
16028374|NCT02678286|Drug|N1539|
16028375|NCT02678286|Drug|Intravenous Placebo|
16028475|NCT02677584|Drug|Therapeutic caffeine citrate|Therapeutic caffeine ( group 2 ) will be defined as caffeine prescribed for manifest apnea within or after the first 72 hours of life . patients will be randomly assigned to receive caffeine in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base).
16028376|NCT02678273|Other|Intervention group|"The Family Medicine Clinic will be the patient centred medical home to manage their complex care needs. A common electronic record will be created for information sharing between care partners. The Integrated Clinical Care Service will provide inpatient care for admitted residents, with emphasis on comprehensive discharge planning and hand-over of care. Patients at high risk of destabilization will receive an early review in outpatient clinic. Home or bed bound residents will be managed by SGH Home Care. The Care Closer to Home comprises a case manager and nursing aides to put in place health, personal and social services e.g. medication management, home help services. The Senior Activity Centre will encourage the elderly to remain integrated in society through community outreach programmes and social recreational activities. A community virtual ward will connect these care providers and weekly meetings to discuss care plans for the frail and sick residents
~."
16028377|NCT02678260|Drug|PDR001|PDR001 is a high-affinity, ligand-blocking, humanized anti-PD-1 IgG4 antibody that blocks the binding of PD-L1 and PD-L2 to PD-1.
16028378|NCT02678247|Device|Northwestern University Flexible Sub-Ischial Vacuum Socket|NU-FlexSIV sockets have lower proximal trim lines, do not impinge on the pelvis, are highly flexible so as to allow better comfort during sitting and when muscles move within the socket during activity, and are held securely to the residual limb by suction from a vacuum pump and from compression exerted by the deliberately undersized liner and socket.
16028379|NCT02678247|Device|Ischial Containment Socket|Ischial Containment (IC) sockets are more rigid and have a narrower medio-lateral dimension than anterior-posterior dimension. The socket encapsulates the ischium, ischial ramus and greater trochanter, limiting hip range of motion and comfort.
16028380|NCT02678234|Drug|Paracetamol, phenylephrine HCl, and vitamin C|One sachet is provided for each participant randomized to the Theraflu Aktiv powder for oral solution
16028381|NCT02678221|Drug|Sildenafil citrate|
16028382|NCT02678221|Drug|Aspirin|
16028383|NCT02678208|Drug|Tranexamic Acid|
16028384|NCT02678208|Drug|5% glucose|
16028385|NCT02678195|Drug|Amoxicillin|Oral amoxicillin dispersible tablets (DT), 250 mg tablets, given according to age band, two times daily
16028386|NCT02678195|Drug|Placebo|Placebo dispersible tablets (DT), 250 mg tablets, given according to age band, two times daily
16028387|NCT02678182|Drug|Capecitabine|1250 mg/m2/day, 21 day cycle
16028388|NCT02678182|Drug|MEDI4736|IV treatment on days 1&15 of 28 day cycle
16028389|NCT02678182|Drug|Trastuzumab|6mg/kg on day 1 cycle every 21 days
16028390|NCT02678182|Drug|Rucaparib|600mg PO twice daily
16028391|NCT02678182|Drug|Ramucirumab|ramucirumab 8mg/kg IV day 1 and day 8
16028392|NCT02678169|Device|Penumbra Aspiration System|Penumbra Aspiration System using the ADAPT technique for recanalization of an occlusion large vessel in the brain
16028393|NCT02678156|Device|Lyoplant Onlay|
16028401|NCT02678130|Device|InterFuse T|Transforaminal Lumbar Interbody fusion (TLIF)
16028402|NCT02678130|Device|Standard of Care TLIF (Stryker AVS Unilif)|Transforaminal Lumbar Interbody Fusion (TLIF)
16028403|NCT02678117|Drug|Pregabalin & Placebo|
16028404|NCT02678117|Drug|Magnesium sulphate & Placebo|
16028405|NCT02678117|Drug|Pregabalin & Magnesium sulphate|
16028406|NCT02678117|Drug|Placebo|
16028407|NCT02678104|Procedure|Tooth extraction|Tooth removal
16028408|NCT02678104|Drug|Chlorhexidine mouth wash|Chlorhexidine mouth wash
16028409|NCT02678104|Drug|Intra-alveolar application of Manuka Honey|Intra-alveolar application of Manuka Honey directly after extraction.
16028410|NCT02678091|Device|Ultrasound exam with Doppler|Ultrasound exam of the orbit
16028411|NCT02678078|Procedure|Analyzing biopsy samples|Analyzing biopsy samples that is preformed as part of the patient treatment.
16028412|NCT02678065|Device|InPact Admiral DEB|
16028413|NCT02678052|Drug|Vedolizumab|Vedolizumab exposure
16028414|NCT02678052|Biological|Other Biological Agent|Other Biological Agent exposure
16028415|NCT02678039|Device|Fluoroscopy|Device: Fluoroscopy Patients lie prone on X-ray compatible operating table and an X-ray device obtains X-ray images of epidural catheter placement. An epidural catheter is placed with local anesthesia as a needle that is advanced into the epidural space. A catheter is then placed through the needle to the desired location and the needle is removed. After the catheter is placed, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusion rate by 2ml/hr up to a maximum of 14ml/hr
16028416|NCT02678039|Procedure|Traditional|An epidural catheter is placed before surgery with the patient sitting at bedside. The catheter is placed with local anesthesia using indirect indicators of proper placement: depth of needle insertion and ability to inject solution through the needle ('loss of resistance'). After needle placement in the epidural space, an epidural catheter is threaded through the needle 3-4 cm and the needle removed. After catheter is placement, a test dose of 1.5% lidocaine with 5ug/cc epinephrine is injected into the catheter to exclude intravascular placement. Following this, a continuous infusion of 1/8% bupivacaine is started at 4ml/hr. After surgery, the bupivacaine infusion may be adjusted with bolus injections of 2ml and/or increase in the infusion rate by 2ml/hr up to a maximum of 14ml/hr.
16028417|NCT02678026|Device|Cervical pessary|Cervical pessary is a medical device used to treat an incompetent (or insufficient) cervix (cervix starts to shorten and open too early). Early in the pregnancy a round silicone pessary is placed at the opening to the cervix to close it, and then remove late in the pregnancy when the risk of a preterm birth has passed.
16028418|NCT02678013|Procedure|RFA|Radiofrequency ablation(RFA)for small recurrent HCC
16028419|NCT02678013|Procedure|RFA+highly-purified CTL|Radiofrequency ablation(RFA) plus highly-purified CTL for small recurrent HCC
16028420|NCT02678000|Drug|LHW090|LHW090 is orally administered
16028421|NCT02678000|Drug|Placebo|Matching placebo of LHW090
16028481|NCT02677545|Drug|Ticagrelor|
16028435|NCT02677883|Other|Manometry-guided thoracentesis|Arm I will undergo a standard of care therapeutic thoracentesis procedure, and in addition include pleural pressure monitoring (via an FDA-approved digital manometer) which is also standard of care but left at the discretion of physicians as per expert recommendations. In this group, the procedure will be stopped when the patient develops symptoms or when all the fluid has been removed, and will also be stopped if the pressure begins to fall quickly in the fluid collection.
16028436|NCT02677883|Other|Symptom-guided thoracentesis|Arm II will undergo a standard of care therapeutic thoracentesis procedure. In this group, the procedure but will be stopped when the patient develops symptoms or when all the fluid has been removed.
16028437|NCT02677870|Drug|saproterin dihydrochloride|The drug will be given as described in the arm/group descriptions.
16028438|NCT02677870|Other|Diet treatment|Patients will maintain a stable, Phe restricted diet (including formula) that is consistent with their diet at the time of enrollment. This will be monitored by food diaries kept for 3 days of each week.
16028439|NCT02677857|Behavioral|Common intervention components for Lifestyle|Participants in these conditions will receive standard care and one of the Lifestyle conditions. There are several components that will be identical for both Lifestyle conditions. These components include treatment structure, dietary goals, and cognitive behavioral strategies.
16028440|NCT02677844|Drug|Abemaciclib|Administered orally
16028441|NCT02677844|Drug|Placebo|Administered orally
16028442|NCT02677844|Drug|Loperamide|Administered orally
16028443|NCT02677805|Drug|Botulinum Toxin A|Injection, 20 Units divided in five 0.1mL i.m injections into the glabellar area
16028444|NCT02677805|Drug|Placebo|injection, sodium chloride 0.9% divided in five 0.1 mL i.m. injections into the glabellar area
16028445|NCT02677792|Behavioral|Behavioral Family Intervention (BFI)|Participating families will receive standard medical care through the Wellness and Weight Clinic, as well as the BFI. The BFI is based on family systems (Minuchin et al., 1975) and social-cognitive (Bandura, 1998) theories. Each dyad will participate in simultaneous, but separate, 75-minute parent and child groups over a 3 month period. The groups will start off meeting every week for 8 weeks and then bi-weekly for 1 month. Thus, dyads will attend a total of 10 group meetings over the 3 month period (12.5 hours of total treatment contact).
16028446|NCT02677779|Procedure|CO2 laser|Single session of CO2 laser debridement
16028447|NCT02677779|Procedure|traditional surgery|Single session of traditional debridement
16028448|NCT02677766|Other|occupational therapy|an intervention phase in the period of hospitalization for rehabilitation in the hospital, aimed mainly at achieving objectives related to the area of self-care and, secondly, the objectives in the areas of productivity and leisure, identified at T0; plus an intervention in the post-discharge at the patient's home, aimed primarily at achieving objectives related to the areas of productivity and leisure time and, secondly, to possible targets in residues of self-care, identified in T0.
16028449|NCT02677766|Other|Usual care|Usual care consists in rehabilitation treatment delivered by a multidisciplinary team
16028450|NCT02677753|Radiation|Fluoroscopy|
16028451|NCT02677740|Device|Inhibitory rTMS (1 Hz)|Participants receive rTMS at a rate of 1 Hz, applied with a 70-mm figure-eight TMS coil connected to a stimulator, over the motor cortex hotspot contralateral to the dominant arm for 20 minutes at an intensity of 90% resting motor threshold (RMT) for a total of 600 TMS pulses. The total number of stimuli applied is well within the published safety guidelines for use of rTMS. rTMS is applied outside the scanner, whereas functional connectivity and neurochemistry are measured with MRI and MRS, respectively, at 7 Tesla. The MRI/MRS data are collected right before and immediately after the inhibitory rTMS intervention.
16028452|NCT02677740|Device|Excitatory rTMS (5 Hz)|Participants receive rTMS at a rate of 5 Hz, applied with a 70-mm figure-eight TMS coil connected to a stimulator, over the motor cortex hotspot contralateral to the dominant arm for 20 minutes at an intensity of 90% RMT for a total of 600 TMS pulses. The total number of stimuli applied is well within the published safety guidelines for use of rTMS. rTMS is applied outside the scanner, whereas functional connectivity and neurochemistry are measured with MRI and MRS, respectively, at 7 Tesla. The MRI/MRS data are collected right before and immediately after the excitatory rTMS intervention.
16028453|NCT02677727|Other|EORTC QLQ-CIPN20|EORTC QLQ-CIPN20 is a 20-item chemotherapy-induced peripheral neuropathy-specific questionnaire which includes three scales assessing sensory (9 items: #31-36, 39, 40, 48), motor (8 items: #37, 38, 41-45, 49), and autonomic (3 items: #46, 47, 50) symptoms and functioning with each item measured on a 1-4 scale (1 - not at all; 4 - very much).
16028454|NCT02677714|Radiation|99mTc-rhAnnexin V-128|Kit for the preparation of 99mTc-rhAnnexin V-128
16028455|NCT02677701|Drug|azithromycin|500mg tablet over-encapsulated to match placebo
16028456|NCT02677701|Drug|placebo (for azithromycin)|
16028457|NCT02677701|Drug|inhaled tobramycin|clinically prescribed inhaled tobramycin used by subjects participating in the study
16028458|NCT02677688|Biological|Autologous EBV specific CTL infusion|
16028459|NCT02677675|Behavioral|Intervention (reminder module)|Reminder module (delivered via SMS and telephone call reminders)
16028460|NCT02677662|Other|Diesel Exhaust|Dilute diesel exhaust
16028461|NCT02677662|Other|Filtered air|Filtered air
16028462|NCT02677649|Other|cranberry|the effect of cranberry on the gut microbiota
16028463|NCT02677649|Other|placebo|the effect of placebo on the gut microbiota
16028464|NCT02677636|Drug|MSRD-100|MSRD-100 is a topical gel.
16028465|NCT02677636|Drug|Vehicle|Vehicle is a topical gel without the active ingredients in MSRD-100
16028466|NCT02677623|Drug|Pyridium|
16028467|NCT02677623|Drug|Sodium Fluorescein|
16028468|NCT02677623|Drug|Mannitol|
16028469|NCT02677623|Other|Normal Saline|
16028470|NCT02677610|Drug|MSRD-100|MSRD-100 is a topical gel.
16028471|NCT02677610|Drug|Vehicle|Vehicle is a topical gel without the active ingredient in MSRD-100
16028472|NCT02677597|Drug|Cisplatin Combined With S-1|
16028473|NCT02677597|Drug|Cisplatin Combined With Paclitaxel|
16028474|NCT02677584|Drug|Prophylactic caffeine citrate|Prophylactic caffeine (group1) will be defined as caffeine prescribed for preterm infant within the first 72 hours of life prior to manifest apnea . patients will be randomly assigned to receive caffeine in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base) .
16028482|NCT02677545|Drug|Clopidogrel|
16028485|NCT02677532|Drug|Levobupivacaine wound infiltration|Wound infiltration with 10 ml levobupivacaine 0.5%
16028486|NCT02677532|Drug|Levobupivacaine epidural bolus|Epidural bolus of 10 ml 0.25% levobupivacaine
16028487|NCT02677532|Drug|Sufentanil epidural bolus|Epidural bolus of 0.15 mcg/kg sufentanil
16028488|NCT02677532|Drug|Morphine|Intravenous slow bolus of 10 mg morphine
16028489|NCT02677532|Device|Epidural catheter placement|Thoracic epidural catheter placement in the T7-T8 or T8-T9 intervertebral space
16028490|NCT02677532|Device|Wound infusion catheters placement|Pre-peritoneal placement of two catheters for wound infusion
16028491|NCT02677532|Drug|Levobupivacaine plus sufentanil epidural infusion|Epidural infusion of levobupivacaine 0.12% plus sufentanil 0.4 mcg/ml at 4 ml/h for 48 h
16028492|NCT02677532|Drug|Levobupivacaine wound infusion|Wound infusion with levobupivacaine 0.25% at 4 ml/h for 48 h
16028493|NCT02677519|Drug|Aptensio XR|Orally-administered extended release formulation of methylphenidate; once daily dosing
16028494|NCT02677506|Procedure|Supraclavicular|Brachial plexus block with supraclavicular approach
16028495|NCT02677506|Procedure|Infraclavicular|Brachial plexus block with infraclavicular approach
16028496|NCT02677493|Biological|IL-YANG Quadrivalent Influenza Vaccine|A single 0.5mL dose administrated as an intramuscular injection.
16028497|NCT02677493|Biological|IL-YANG Flu Vaccine Prefilled Syringe|A single 0.5mL dose administrated as an intramuscular injection.
16028498|NCT02677493|Biological|IL-YANG Trivalent Influenza Vaccine|A single 0.5mL dose administrated as an intramuscular injection.
16028499|NCT02677480|Dietary Supplement|Test group, probiotic tablets and gel|Effect of probiotic tablets and gel on acidogenic bacteria
16028500|NCT02677480|Dietary Supplement|Placebo group, placebo tablets and gel|Effect of placebo tablets and gel on acidogenic bacteria
16028501|NCT02677467|Biological|Blood-pressure variability|Day to Night Blood pressure variability
16028502|NCT02677454|Device|Flash Glucose Monitor|
16028503|NCT02677441|Procedure|Conservative management|Specific standardized rehabilitation protocol under Cote et al (2010)
16028504|NCT02677441|Procedure|Surgery|Coracoclavicular and acromioclavicular fixation as described ly Lädermann et al (2011), followed by specific standardized rehabilitation protocol under Cote et al (2010).
16028505|NCT02677428|Behavioral|Remotely-Delivered Benefits Counseling|Veterans will complete three intervention modules online. For the first module, Veterans will be instructed on how to use the website and its purpose; will be asked about their perception of the relationship between disability benefits and work. An explanation of relationship between disability benefits and work will be provided. For the second module, Veterans' feelings and attitudes towards employment will be solicited. Motivational Interviewing exercises will be implemented; barriers to work including the disabling condition and consideration of treatment for disabling conditions will be reviewed. An action plan will be developed. For the third module, inquiries will be made regarding the Veteran's reaction to the service-connection decision; information will be provided on how to appeal the decision. Veterans will be asked to reconsider work and financial goals in light of service-connection award. Their action plan will be reviewed. Follow-up resources will be provided.
16028506|NCT02677428|Behavioral|Control|The control condition will involve referrals to VA websites and represents enhanced treatment-as-usual. A Veteran who completes a Compensation examination ordinarily has no further treatment or referral as part of the Compensation examination. The information about benefits-related websites controls for having information available about benefits and receiving encouragement to pursue that information. The control condition involves being urged to explore links to three VA websites with Compensation & Pension-related information: (a) the VBA website with links about VA disability compensation, (b) the VBA site with fact sheets about the different types of benefits available to Veterans, and (c) the VBA websites for the local C&P office where issues pertaining to an individual Veteran's specific application are addressed.
16028507|NCT02677415|Other|Intravenous anesthetics|
16028508|NCT02677415|Other|local anesthesia|
16028509|NCT02677415|Other|Controlled ventilation|
16028510|NCT02677415|Other|Spontaneous breathing|
16028511|NCT02677402|Other|immersion|
16028512|NCT02677389|Other|Educational Intervention|Receive educational material regarding physical activity and standardized emails with wellness tips and information on stress management
16028513|NCT02677389|Other|Internet-Based Intervention|Receive email and technical or how-to support from study coordinator
16028514|NCT02677389|Device|Monitoring Device|Wear a Fitbit web-integrated physical activity tracker
16028515|NCT02677389|Other|Quality-of-Life Assessment|Ancillary studies
16028516|NCT02677389|Other|Questionnaire Administration|Ancillary studies
16028517|NCT02677376|Other|18F-Sodium Fluoride (NaF)|NaF is a tracer (dye) that will show changes to the cancer in bones. By using this tracer with PET/CT imaging, our ability to evaluate and measure changes in bone lesions could be greatly improved. Participants will have a NaF PET/CT scan within 14 days prior to starting enzalutamide. All subjects will undergo a second NaF PET/CT scan after taking enzalutamide for 12 weeks. The NaF PET/CT obtained at week 12 will be compared to the first NaF PET/CT to identify a bone tumor that is responding (shrinking) and a bone tumor that is not responding (not shrinking).
16028518|NCT02677363|Other|Resistance Exercise|Participants 60 and above aged (both females and males) will perform one hour of resistance exercise twice weekly for 8 weeks.
16028519|NCT02677350|Drug|Allogeneic Bone Marrow derived Human Mesenchymal Stem Cells (hMSCs)|Peri-fistula injections
16028520|NCT02677337|Other|chart abstraction|chart abstraction will be conducted pre and post education intervention to assess efficacy of education at point of care
16028521|NCT02677337|Other|Educational Program|
16028522|NCT02677324|Drug|ABT199|Oral BCL-2 antagonist
16028523|NCT02677311|Procedure|Blood draw|Blood draws will be performed immediately prior to GnRHa treatment and at 6 and 12 months following treatment completion
16028524|NCT02677311|Procedure|Pelvic Ultrasound|Pelvic ultrasound will be performed immediately prior to GnRHa treatment and at 6 and 12 months following treatment completion
16028525|NCT02677298|Drug|Botulinum Toxin A|Injection, 20 Units divided in five 0.1 mL i.m. injections into the glabellar area.
16028526|NCT02677298|Drug|Placebo|Injection, sodium chloride 0.9 mg divided in five 0.1mL i.m. injections into glabellar area
16028527|NCT02677285|Other|Different type of wound|
16028531|NCT02677246|Drug|Denosumab|"Denosumab, one sub-cutaneous infusion, given within 2 weeks after engraftment defined as neutrophils > 0,5x10(9)/L and chimerism ≥ 10% of donor origin.
~Before starting Denosumab several requirements have to be met: 1) Calcemia and Phosphatemia in the normal ranges, 2) adequate Calcium and Vitamin D intakes according to age.
~Biological activity of Denosumab measured by CTX blood level, expected to last for 4 to 6 months after one infusion.
~Possibility of subsequent infusions at the same dose level, every 5 to 6 months, for patient remaining on corticotherapy, provided no DLT occurred and provided CTX blood level decreased under the required threshold, after the previous infusions of Denosumab"
16028532|NCT02677220|Device|CI532 cochlear implant|
16028533|NCT02677207|Drug|JNJ-39393406|JNJ-39393406 100 mg capsules or placebo daily for the first week and 200 mg daily for the rest of the trial
16028534|NCT02677207|Drug|Placebo|JNJ-39393406 100 mg capsules or placebo daily for the first week and 200 mg daily for the rest of the trial
16028535|NCT02677194|Device|LED|There are 7 mini-zones of 1,5x1,5 cm at the level of forearm, one of them is allocated to control ( only laser). Dermabrasion by fractional laser CO2 ablative, evaluation of the pain on every zone by VAS post-act. Exposition to LED (630nm, 830nm and 590 nm). Water loss measure and colorimetry before and after laser and after the exposition to LED. Clinical evaluation of local tolerance post-laser and post-LED + standardized photographs.
16028536|NCT02677194|Other|Control device|Device without any LED exposition
16028537|NCT02677181|Drug|ATG|rabbit ATG（Sanofi）
16028538|NCT02677181|Drug|CsA|cyclosporine (3 mg/kg, q12h, i.v.) was used from day -9, and the concentration was adjusted to 180-200 ng/mL. CsA was switched to oral administration when the patient's bowel function recovered.
16028539|NCT02677181|Drug|mycophenolate mofetil|From day -9, 0.5 g of mycophenolate mofetil was administered orally from every 12 h, which was withdrawn on day +30 for MSD-PBSCT.
16028540|NCT02677181|Drug|Methotrexate|short-term methotrexate
16028541|NCT02677168|Device|cNEP|continuous negative external pressure
16028542|NCT02677155|Radiation|Radiotherapy|Radiotherapy 8 Gy single dose
16028543|NCT02677155|Biological|Rituximab|Intranodal injection 5 mg
16028544|NCT02677155|Biological|Autologous dendritic cells|Intranodal injection of 1 x 10 e8 cells
16028545|NCT02677155|Biological|GM-CSF|Subcutaneous injection of 50 ug
16028546|NCT02677155|Biological|Pembrolizumab|Intravenous infusion of 200 mg
16028547|NCT02677142|Behavioral|Structured social skills training program, SSIP|Detailed, session by session, in the manual written for this purpose. It addresses six major social skills, one per session, starting with easier skills (Social Initiation and Friendship Making, Cooperation) and moving towards more complex skills (Managing Teasing and Bullying, Conflict Resolution, Empathy, and Assertion).
16028548|NCT02677142|Behavioral|CG - social skills activities|Sessions will not be designed around a specific social skill and activities and games will not have a specific focus. CG sessions will be conducted by facilitators who will receive the standard training for volunteers and will work under the supervision of one of the investigators at each site.
16028549|NCT02677129|Other|home-based exercise intervention|Endurance training (moderate intensity; walking), 3-5 times per week Patients will receive exercise counselling how to realize the planned intervention home-based. Further, they will be asked to fill out an exercise log. The study team will periodically review adherence to the intervention and identify problems.
16028550|NCT02677116|Drug|Olaratumab|Olaratumab administered IV.
16028551|NCT02677116|Drug|Doxorubicin|Doxorubicin administered IV.
16028552|NCT02677116|Drug|Vincristine|Vincristine administered IV.
16028553|NCT02677116|Drug|Irinotecan|Irinotecan administered IV.
16028554|NCT02677116|Drug|Ifosfamide|Ifosfamide administered IV.
16028555|NCT02677103|Device|radial extracorporeal shock wave therapy|he RSWT was delivered at 2 Hz with 2000 shock waves and the energy level of 0.26mJ/mm2 in calcific tendinitis of shoulder.
16028556|NCT02677103|Procedure|ultrasound-guided needle puncture|After injecting 3cc 1% Xylocain in the subcutaneous tissue, muscle layer and subdeltoid bursa, multiple back-and-forth puncture about 10-20 times (depending on the size of the plaques) within the calcific plaques will be performed.
16028557|NCT02677103|Procedure|RSWT and USNP|each subject will receive radial shock wave therapy after ultrasound-guided needle puncture, as described in the previous paragraphs.
16028558|NCT02677090|Drug|Placebo (including Maltodextrin)|
16028559|NCT02677090|Drug|Dose 1 - Promitor®|
16028560|NCT02677090|Drug|Dose 2 - Promitor®|
16028561|NCT02677090|Drug|Dose 3 - Promitor®|
16028562|NCT02677077|Drug|natalizumab|Participants with RRMS receiving commercial natalizumab in Belgium and Czech Republic
16028563|NCT02677064|Other|assessments|Thus, a prospective observational study in which all newly diagnosed or newly relapsed acute leukemia patients would be registered close to the beginning of induction or re-induction therapy would allow us to follow patients throughout their journey and identify prospectively the reasons why patients did not proceed to HCT when deemed appropriate and eligible.
16028564|NCT02677051|Drug|Sulforaphane|Sulforaphane (1-isothiocyanato-4R- (methylsulfinyl)butane) is an isothiocyanate derived from the action of the plant enzyme myrosinase on glucosinolates including glucoraphanin and comes from consumption of many cruciferous vegetables.
16028565|NCT02677051|Drug|Placebo|
16028566|NCT02677038|Drug|Olaparib|Given PO
16028567|NCT02677025|Behavioral|Young Women's Health CoOp (YWHC)|Participants in this group will participate in two workshops of the young woman-focused intervention about HIV/STIs (sexually transmitted infections), sexual behaviors, alcohol and other drug use, violence, communication skills, and other issues. Participants will develop personalized risk reduction action plans at the end of each workshop session.
16028568|NCT02677025|Behavioral|HIV Counseling/Testing|Participants will be tested for HIV and if positive will receive counseling in accordance with national standards.
16028569|NCT02677012|Procedure|Autologous Fat Graft|Undergo AFG using the RESOLVE TM technique
16028570|NCT02677012|Procedure|Autologous Fat Graft|Undergo AFG using the Cytori PureGraft TM technique
16028571|NCT02677012|Procedure|Autologous Fat Graft|Undergo AFG using the Coleman technique
16028572|NCT02677012|Procedure|Reconstructive Surgery|Undergo reconstructive surgery
16028573|NCT02676999|Procedure|Implantation of a Scheker total distal radioulnar joint prosthesis|
16028574|NCT02676986|Drug|Enzalutamide|Anti-androgen
16028575|NCT02676986|Drug|Exemestane|Hormonal therapy (Licenced)
16028576|NCT02676973|Procedure|Open, Robotic, or Laparoscopic|Sacral Colpopexy is a surgery performed either through an incision in the abdomen or through several small incisions with the help of a laparoscope (a slender tube) or robot. The surgery is done with a permanent synthetic (man-made) mesh. The mesh is sutured (stitched) to the vagina and sacrum (tail bone) and is used as reinforcement. It provides additional support to weakened tissues and/or muscles.
16028577|NCT02676973|Procedure|Transvaginal Native Tissue Repair|Transvaginal Native Tissue Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done using both permanent and absorbable sutures (stitches), to support weakened tissue and/or muscles, and attach the top of the vagina to ligaments in the pelvis (either to the sacrospinous ligament or uterosacral ligament).
16028578|NCT02676973|Procedure|Uphold™ LITE|Transvaginal Mesh Repair is a surgery performed with an incision through the vagina (transvaginal). The surgery is done with a permanent synthetic (man-made) mesh. The mesh is attached to ligaments in the pelvis and is used to reinforce natural tissue and/or muscles, which are no longer able to provide support to the vagina.
16028579|NCT02676960|Other|MRI without sedation|
16028580|NCT02676947|Drug|Tocilizumab|
16028581|NCT02676934|Device|End tidal control module in Aisys anesthesia workstation|THE USE OF AUTOMATED CONTROL OF END TIDAL SEVOFLURANE CONCENTRATION TO MAINTAIN ANESTHESIA DURING DONOR HEPATECTOMY
16028582|NCT02676908|Other|Compression socks for 2 weeks|Patients in the intervention group will be asked to wear compression stockings for two weeks post-operatively
16028583|NCT02676895|Biological|GVGH S. sonnei (1790GAHB) vaccine 25 μg|Two injections of the study vaccine were administered 28 days apart.
16028584|NCT02676895|Biological|GVGH S. sonnei (1790GAHB) vaccine 100 μg|Two injections of the study vaccine were administered 28 days apart.
16028585|NCT02676895|Biological|Menveo|One injection of Menveo was administered in subjects in the Control Group.
16028586|NCT02676895|Biological|Boostrix|One injection of Boostrix was administered in subjects in the Control Group.
16028587|NCT02676882|Dietary Supplement|EnBrace HR|Prescription folate prenatal supplement with other dietary ingredients; one multiphasic soft gelatin capsule 1x/day for 12 week study
16028588|NCT02676869|Drug|IMP321 (eftilagimod alpha)|"Part A: Single subcutaneous injections of 1 mg (cohort 1), 6 mg (cohort 2) or 30 mg (cohort 3) of IMP321 administered every 2 weeks
~Part B: Single subcutaneous injections of 30 mg of IMP321 administered every 2 weeks"
16028589|NCT02676869|Drug|Pembrolizumab|Administered according to the approved label.
16028590|NCT02676856|Procedure|hematopoietic stem cell microtransplantation-long-term|Stem cell infusion are administrated once three months for 3 times with the cell count of 3*10^8/kg/once.
16028591|NCT02676856|Procedure|hematopoietic stem cell microtransplantation-short-term|Stem cell infusion are administrated once every 45 days for 3 times with the cell count of 3*10^8/kg/once.
16028592|NCT02676856|Drug|Conditioning for CR group|For the patients in CR group, the conditioning regimen is high-dose Ara-C (3g/m2 q12h d1-3).
16028593|NCT02676856|Drug|Conditioning for Non-CR group|For the patients in Non-CR group, the conditioning regimens include: IAC（IDA 12mg/m2 d1-3，Ara-C 200 mg/m2 d1-7， Cladribine 5mg/m2 d1-5) or HD Ara-C(high-dose Ara-c 3g/m2 q12h d1-3).
16028594|NCT02676843|Drug|18F-AV-1451|A single injection of up to 10 millicuries of 18F-AV-1451 will be administered to subjects, followed by a 20-minute PET scan.
16028595|NCT02676830|Drug|K-312 100 mg|Single oral dose
16028596|NCT02676830|Drug|K-312 100 ug C14 IV|microtracer dose containing ≤37 kBq (1000 nCi) [14C] given as a 5-ml IV push over 2 minutes
16028597|NCT02676804|Other|High-intensity, aerobic exercise.|"Aerobic exercise will blend unsupervised moderate and supervised high intensity exercise. It will consist of walking/jogging modalities, dependent on the subject's level of bradykinesia, paced by the subject's level of perceived exertion. The exercise protocol will be designed to target an total of at least 150 minutes of cardio exercise per week.
~Exercise training will be performed 5 times per week for 6 weeks, consisting of 3 supervised high intensity sessions and 2 at home moderate intensity sessions. High intensity sessions will be performed on a treadmill at an intensity rating of ~ 15 and 17 on a rating of perceived exertion (RPE) scale of 6 to 20. The moderate intensity exercise will target an RPE of ~10 - 12 and participants will be asked to complete this on their own."
16028598|NCT02676791|Drug|Povidone-Iodine|A standard nasogastric tube will be inserted into all patients after induction of general anesthesia. After surgical dissection, the esophagus / stomach will be cut at the desired level leaving the tip of the nasogastric tube proximal to the esophageal carcinoma. Then, 50ml of a 11% povidone-iodine solution (Betaisodona®, Mundipharma) will be introduced into the esophagus via the nasogastric tube and evacuated with a suction device (washout). The nasogastric tube will then be removed for completion of esophageal resection and beginning of reconstruction.
16028599|NCT02676778|Drug|E7777|
16028600|NCT02676765|Drug|Allergen|1 allergen extract tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet
16028601|NCT02676765|Drug|Placebo|1 placebo tablet, placed under the tongue until dissolved, taken daily; do not swallow for 1 minute after placing tablet; do not eat or drink for 5 minutes after placing tablet
16028602|NCT02676752|Procedure|Medical Examination|Evaluation of secondary lymphedema and fibrosis (LEF) status
16028603|NCT02676752|Other|Questionnaire Administration|Completion of questionnaires
16028604|NCT02676752|Procedure|Shear Wave Elastography|Undergo ultrasound shear wave elastrography
16028605|NCT02676739|Drug|Adderall XR|
16028606|NCT02676726|Procedure|Extraperitoneal Laparoscopic aortic lymphadenectomy|Aortic/para-aortic lymph nodes dissection and retrieval by extraperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy.
16028607|NCT02676726|Procedure|Transperitoneal Laparoscopic aortic lymphadenectomy|Aortic/para-aortic lymph nodes dissection and retrieval by transperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy.
16028608|NCT02676713|Drug|pre-ovulation Decoction|HuoXueXiaoYi Decoction(Bupleurum 10g, Cyperus 10g, Salvia miltiorrhiza 20g, Red peony 10g,etc)has activating blood and absorbing clots effect, can inhibit the growth of ectopic endometrium, promote follicular growth, maturity, improve ovulation and the receptivity of endometrium.
16029620|NCT02668861|Drug|Vitamin D|Vitamin D 4000IU/day for 8 weeks
16028609|NCT02676713|Drug|post-ovulation Decoction|"BuShenZhuYun Decoction(Bupleurum 10g,Poria 15g, Atractylodes 15g,Ligustrum 15g,etc) has dredging liver and nourishing kidney effect, can improve the function of corpus luteum.
~All are made into granules."
16028610|NCT02676713|Drug|pre-ovulation Decoction(placebo)|Composition of maltodextrin, lactose, edible pigment, taste masking agent.
16028611|NCT02676713|Drug|post-ovulation Decoction(placebo)|Composition of maltodextrin, lactose, edible pigment, taste masking agent.
16028612|NCT02676700|Behavioral|Pelvic floor muscle training and Kaatsu|The intervention includes three outpatient visits (weeks 0, 6 and 12) and between visits the participants perform PFMT and Kaatsu training as home training
16028613|NCT02676700|Behavioral|Pelvic floor muscle training|The intervention includes three outpatient visits (weeks 0, 6 and 12) and between visits the participants perform PFMT as home training
16028614|NCT02676687|Procedure|total resection|Removing the parenchyma until signal abnormalities on FLAIR-weighted MR / enhanced-weighted MR in adults with glioma
16028615|NCT02676687|Procedure|supratotal resection|Extended removing the parenchyma at least 1cm beyond signal abnormalities on FLAIR-weighted MR / enhanced-weighted MR in adults with glioma
16028616|NCT02676674|Drug|Dose 1|Subjects with vitamin D deficiency will be given 100,000 units of topical vitamin D on days 0,7, and 14. Vitamin D levels will be checked on days 7, 14, and 21.
16028617|NCT02676674|Drug|Dose 2|Subjects with vitamin D deficiency will be given 300,000 units of topical vitamin D on days 0,7, and 14. Vitamin D levels will be checked on days 7, 14, and 21.
16028618|NCT02676648|Behavioral|Multicomponent online program|The core program includes information developed in earlier research with individuals with type 2 diabetes, now modified for online delivery: very low-carbohydrate diet taught with lectures on video, handouts, quizzes, and surveys. We also teach participants about the importance of physical activity and adequate sleep, in addition to psychological skills (positive affect, mindful eating) intending to help with intervention adherence.
16028619|NCT02676648|Behavioral|Breath meter|We will send participants a breath meter to test ketones in their breath, to assess dietary adherence.
16028620|NCT02676648|Behavioral|Text messages|We will send participants text messages, to support intervention adherence.
16028621|NCT02676648|Behavioral|Diet-appropriate foods and cookbooks|We will send participants diet-appropriate foods and cookbooks, to support intervention adherence.
16028622|NCT02676635|Behavioral|Ergonomics training and/or Safety Voice training|"Ergonomics training will focus on ergonomic principles specific to masonry such as goals of ergonomics, common musculoskeletal disorders among masons, modifiable work factors and risk factors, hazard analysis, hierarchy of controls, and current ergonomic solutions for masonry. Safety Voice training will focus on development of skills such as self-direction, self-control, accountability, responsibility, communication strategies, and leadership that can help them to develop a safety voice about safety in general, and ergonomics specifically."
16028623|NCT02676622|Drug|mobilization of stem cells to prepare for Leukapheresis|"Cyclophosphomide 2 g/m2 x 2 consecutive days.
~Filgrastim (G-csf) 10 mcg/kg SC will start 5 days after the last dose of CY and will end the day before the last leukapharesis."
16028624|NCT02676622|Other|Leukapheresis- Collection of stem cells|"Placement of an Apheresis Catheter on the day of collection of stem cells.
~Leukapheresis will be performed on a continuous flow separator machine to target 3-8 x 106 CD34+ cells/kg body weight."
16028625|NCT02676622|Drug|Preparative regimen 4-6 weeks after Leukapheresis|"Prior to starting medicines, a central venous line will be placed (arm or chest)
~Cyclophosphamide iv: 50 mg/kg iv over 2 hours
~Mesna iv (uro-protectant): 36 mg/kg iv over 12 hours
~r-ATG (Thymoglobulin, Genzyme): 2.5 mg/kg/dose iv over 6 hours on days -3,-2,-1"
16028626|NCT02676622|Other|Stem Cell Transplant|"Infusion of the(cryopreserved and thawed)peripheral blood stem cells (PBSC)occurs on Day 0.
~Day +5: start Filgrastim (G-csf) subcutaneous injections
~Hospitalization in isolation room for 4-5 weeks"
16028627|NCT02676622|Drug|Low-dose IL-2 administration|"IL-2 Subcutaneous injections will start once ANC is > 500/µL and patient is afebrile (start IL-2 will be approximately day +20)for 6 weeks of treatment.
~Once patient or parent has learnt the administration and patient is tolerating it well, then the rest of the treatment can be administered at home after discharge with weekly follow up visits."
16028628|NCT02676609|Device|Automated carbohydrate and meal insulin dose computing|Use of smart phone application will compute carbohydrate amount and meal insulin dose according to individual meal insulin/carbohydrate ratio.
16028629|NCT02676596|Drug|K-312 10 mg QD|
16028630|NCT02676596|Drug|K-312 25 mg QD|
16028631|NCT02676596|Drug|K-312 50 mg QD|
16028632|NCT02676596|Drug|K-312 100 mg QD|
16028633|NCT02676596|Drug|K-312 200 mg QD|
16028634|NCT02676596|Drug|K-312 400 mg QD|
16028635|NCT02676596|Other|Placebo|
16028636|NCT02676583|Procedure|Tonsillectomy|Closure or not closure of tonsil fossa
16028637|NCT02676557|Device|Exposed to the high pressure during the surgery|
16028638|NCT02676544|Device|Embosphere microspheres|This is a clinical trial assessing the feasibly and safety of prostate artery embolization (PAE) for benign prostatic hypertrophy (BPH) resulting in severe lower urinary tract symptoms (LUTS) in patients with gland size ≥90 grams who are TURP ineligible or non-operative candidates with Embosphere microspheres.
16028639|NCT02676531|Other|Exercise|Walking meditation exercise program
16028640|NCT02676518|Other|serum|Serum for serum anti-Mullerian hormone, 2-hour 75 gram oral glucose tolerance test and lipid profiles
16028641|NCT02676505|Behavioral|Coached pushing group|It includes 217 patients who are admitted in active stage of labor (cervical dilatation 4cm at least) to labor delivery ward. They are coached by the nurse to use closed-glottis and pushing three to four times during each contraction immediately when cervical dilation reached 10 cm and to continue pushing using this method with each contraction until birth. The nurse counts to 10 during each pushing effort to assist the woman in holding her breath for at least 10 seconds.
16028642|NCT02676505|Behavioral|uncoached pushing group|It includes 217 patients who are admitted early in active stage of labor (cervical dilatation 4cm at least) to labor delivery ward at 10-cm cervical dilation where they remain until they feel the urge to push or the second stage had lasted 2 hours (whichever came first)., they are encouraged to bear down with contractions without holding their breath (open-glottis) for no more than 6-8 seconds and continue bearing down no more than three times with each contraction until birth. .
16029926|NCT02666794|Drug|Intrathecal morphine|60 mcg
16028643|NCT02676492|Other|Actigraphy to measure sleep duration and efficiency|Actigraphy watch to be worn on participants' wrist for 14 days and nights
16028644|NCT02676492|Other|'Sleepsuite' novel cognitive learning tasks|Novel iPad-administered learning tasks, to be completed one evening and the next morning during actigraphy monitoring period.
16028645|NCT02676479|Device|Uterine Lavage Group|"The PI places the Lavage Catheter per instructions for use
~Use of a tenaculum or cervical stitch is required
~Use of saline to wash the cervix is required
~Use of abdominal ultrasound guidance with a full bladder is required The PI records if there was clinically significant fluid loss through the cervix."
16028646|NCT02676466|Dietary Supplement|Omega-3 fish oil|The Omega-3 fish oil will be provided in 700 mg gelcaps. The starting dose will be 1.4 g/day of fish oil and continue until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), we increase the dose to 2.8 g/day.
16028647|NCT02676466|Drug|Losartan|The Losartan will be provided in 25 mg and 50 mg capsules. The starting dose will be 25 mg/day, if tolerated, then stepped up to 50 mg/day. If there are no safety concerns, a continuation of 50 mg/day will be provided until the 6 month visit. If the average of IL-6 measured at 3- and 6-month visits does not decrease by >40% vs. baseline (average of screening visits 1 and 2), an increase to the dose of 100 mg/day.
16028648|NCT02676466|Other|Corn Oil (Fish oil Placebo)|The corn oil placebo gel caps will be identical in shape, color, taste and weight as the Omega-3 fish oil.
16028649|NCT02676466|Other|Cellulose Based (Losartan Placebo)|The placebo cellulose based capsules will be identical in shape, color, taste and weight as the losartan capsules.
16028650|NCT02676453|Other|Intervention|Dental hygienist support
16028651|NCT02676440|Other|Treatment|F13/T38
16028652|NCT02676440|Other|Comparator|M26
16028653|NCT02676427|Procedure|passive leg raising|passive leg raising under echocardiographic monitoring with intravascular doppler in place
16028654|NCT02676414|Behavioral|Interactive hypertension education program of the DHL©|
16028655|NCT02676401|Drug|MT-3995 Low|
16028656|NCT02676401|Drug|MT-3995 Middle|
16028657|NCT02676401|Drug|MT-3995 High|
16028658|NCT02676388|Procedure|Freeze-dried, Capsulized FMT|
16028659|NCT02676388|Procedure|Fresh FMT|
16028660|NCT02676375|Drug|Combination Bupropion + NRTs|
16028661|NCT02676375|Other|Extended Treatment|
16028662|NCT02676375|Other|Home Visits & Calls|
16028663|NCT02676375|Drug|Monotherapy|
16028664|NCT02676362|Other|Gingival crevicular fluid collection with filter paper|Gingival Crevicular Fluid Dynamics
16028665|NCT02676349|Drug|mFolfirinox|oxaliplatin folinic acid irinotecan 5FU oxaliplatin
16028666|NCT02676349|Radiation|Chemoradiotherapy|conformational external irradiation (50.4 Gy) + capecitabine
16028667|NCT02676349|Procedure|surgery|1 to 4 weeks after neoadjuvant treatment according to tumour response
16028668|NCT02676349|Drug|Adjuvant chemotherapy|Gemcitabine or modified LV5FU (folinic acid+-bolus fluorouracil+ infusional fluorouracil)
16028669|NCT02676336|Dietary Supplement|Violet™ Molecular Iodine (I2)|
16028670|NCT02676336|Other|Placebo|
16028671|NCT02676323|Drug|Panobinostat|Panobinostat will be given orally (PO) on days 1, 3, 5, 8, 10, and 12.
16028672|NCT02676323|Drug|Fludarabine|Fludarabine will be given intravenously (IV), 30 mg/m^2/dose over 30 minutes, daily for 5 days (days 8-12).
16028673|NCT02676323|Drug|Cytarabine|Cytarabine will be given IV, 2 gram/m^2/dose over 4 hours, daily for 5 days (days 8-12).
16028674|NCT02676323|Drug|Intrathecal Triples|Given intrathecally (IT).
16028675|NCT02676323|Drug|Leucovorin|Leucovorin (5 mg/m^2/dose, max 5 mg) may be given PO or IV at 24 and 30 hours after each ITMHA.
16028676|NCT02676310|Drug|Bimatoprost|
16028677|NCT02676297|Drug|tiotropium|four inhalations
16028678|NCT02676284|Device|Durolane SJ|single dose injection
16028679|NCT02676271|Procedure|Proximal varus derotational osteotomy|The purpose of surgery was to relocate the protruded, deformed femoral head from its lateral position back to the acetabulum to achieve containment. Surgery was preceded by a hip arthrography with dynamic examination to find the suitable containment position and plan the correct osteotomy angles accordingly. A sub trochanteric osteotomy was performed then after in an open or closed wedge form, with fixation in an angle that gave best coverage.
16028680|NCT02676258|Device|Si-Hy (olifilcon B)|Wear Si-Hy silicone hydrgel soft contact lens for 3 months
16028681|NCT02676258|Device|Vistakon (narafilcon A)|Wear Vistakon soft contact lens for 3 months
16028682|NCT02676245|Behavioral|Viewing Newborn Screening movie|NBS Movie and printed brochure were viewed by the participants
16028683|NCT02676245|Behavioral|Viewing Residual Dried Blood Spot movie|DBS Movie and and printed brochure were viewed by the participants
16028684|NCT02676232|Behavioral|DARWeb|Psychosocial Intervention from the cognitive-behavioral model, including different but related units for parents and children with recurrent abdominal pain.
16028685|NCT02676219|Other|RS01|Oral Care product containing sodium monofluorophosphate and sodium fluoride
16028686|NCT02676219|Other|Water|
16028687|NCT02676206|Other|Classical music|Classical music will be played over the headphones
16028688|NCT02676193|Behavioral|Effect of Packaging on Smoking Perceptions and Behavior|The intervention is the use of the assigned pack design.
16028689|NCT02676180|Other|Group|
16028690|NCT02676167|Behavioral|PrEP Intervention|
16028691|NCT02676154|Drug|Fesoterodine|4mg, oral, once daily for 12 weeks; dose adjustments may be permitted.
16028692|NCT02676141|Other|Manual Therapy|The treatment the patients receive is not specifically set up for the study. Participants will already be seeing a practitioner before the participants are included in the study.
16028693|NCT02676128|Behavioral|Twine Collaborative Care Application|This application features a 24-hour medication clock that displays ART dosing schedule and allows participants to record the doses taken. It also features an interactive health coaching feature which will be used to provide support, encouragement, and resources to participants.
16028694|NCT02676128|Behavioral|Information-Motivation-Behavioral Skills Model of ART Adherence|Combines brief motivational interviewing, cognitive behavior therapy, and problem-solving skills to help participants formulate and follow ART adherence goals.
16135133|NCT01896349|Drug|tranylcypromine|
16028695|NCT02676115|Other|Standard Post Operative Skin Care|Control group subjects will receive the standard post-operative skin care which are steri-strips covered with gauze, and this will be removed at the first visit. No additional skin dressings will be used in the control group.
16028696|NCT02676115|Other|Medipore Tape|"One layer of Medipore tape will be placed across the incision.
~Patients will be instructed on how to change the tape, and will be encouraged to change the tape as often as once per week for hygiene.
~When patients return to the office for their regularly scheduled visit, the Medipore tape will be changed and a picture of the scar will be taken."
16028697|NCT02676102|Behavioral|Control Group|Generic Video about organ donation
16028698|NCT02676102|Behavioral|Targeted Intervention|an educational video produced in partnership with the community of black men including customers, employees, and owners of BOBs. Video production was informed by entertainment education models and produced with experts including an Academy Award winning filmmaker.
16028699|NCT02676102|Behavioral|Tailored Intervention|Videos with content individualized to participant's pre-intervention Organ Donation Belief Index (ODBI).
16028700|NCT02676089|Drug|CHF 5993 200/6/12.5 µg|
16028701|NCT02676089|Drug|CHF 1535 200/6 µg|
16028702|NCT02676089|Drug|CHF 1535 200/6 µg + Tiotropium Respimat 2.5 µg|
16028703|NCT02676076|Drug|CHF 5993 100/6/12.5 µg|
16028704|NCT02676076|Drug|CHF 1535 100/6 µg|
16028705|NCT02676050|Other|Optical Imaging Agents (EMI-137, NAP)|Both optical imaging agents (NAP and EMI-137) will be administered to each patient during a bronchoscopy procedure. A novel delivery catheter (to deliver both agents), imaging fibre and endomicroscopy system with viewer software will be used to detect c-MET and activated neutrophil signal in the human lung.
16028706|NCT02676050|Device|Delivery Device Cathetar and Miniaturised imaging fibre|Both optical imaging agents (NAP and EMI-137) will be administered and imaged simultaneously during a bronchoscopy procedure using the devices mentioned above.
16028707|NCT02676050|Device|Optical endomicroscopy system|The signal emitted by both optical imaging agents (NAP and EMI-137) will be visualised using a novel endomicroscopy system.
16028708|NCT02676037|Device|foot pressure plate form|
16028709|NCT02676024|Device|Knowledge-based cognitive aid|"Trained on the use of a knowledge-based cognitive aid for pediatric cardiac arrests. Will be used by a dedicated team member (cognitive aid reader)."
16028710|NCT02676024|Device|Cognitive aids with roles defined (CARD)|"Trained on the use of the cognitive aids with roles defined (CARD) system for pediatric cardiac arrests. Participants are given large identification cards to be worn, which enable the code leader to quickly recognize the individuals' purpose at the code. The card identifies specific tasks associated with the role, ensuring that the participant knows exactly what their task is. Will not have a dedicated team member during the scenario (cognitive aid reader)."
16028711|NCT02676024|Device|Integrated cognitive aids|"Trained on the use of the cognitive aids with roles defined (CARD) system and also in the use of a protocol-based cognitive aid for pediatric cardiac arrests which will be used by a dedicated cognitive aid reader."
16028712|NCT02676011|Drug|IM atropine|Atropine (0.01 mg/kg) (1 ml) IM 30 minutes before induction of anesthesia
16028713|NCT02676011|Drug|IV atropine|Atropine (0.01 mg/kg) intravenously (10 ml) 3 minutes before induction of anesthesia
16028714|NCT02676011|Drug|Atropine mixed with second dose succinylcholine|Atropine (0.01 mg/kg) added to the second dose succinylcholine (1mg/kg) prepared to 5 ml syringe with normal saline
16028715|NCT02676011|Drug|IM normal saline|1 ml normal saline IM 30 minutes before induction of anesthesia
16028716|NCT02676011|Drug|IV normal saline|IV 10 ml normal saline 3 minutes before induction of anesthesia
16028717|NCT02676011|Drug|Normal saline mixed with second dose succinylcholine|Second dose succinylcholine (1 mg/kg) prepared to 5 ml syringe with normal saline
16028718|NCT02675998|Drug|Tenapanor|
16028719|NCT02675998|Drug|Placebo|
16028720|NCT02675985|Other|Physical Therapy|Early Intensive Physical therapy in the ICU
16028721|NCT02675959|Drug|Defibrotide|defibrotide will be given prophylactically prior to AlloSCT to determine if it decreases the incidence of SOS in this high risk population, and determine that it is safe and feasible to give along with myeloimmunoablative therapy and allogeneic transplant.
16028722|NCT02675946|Drug|CGX1321|
16028723|NCT02675946|Drug|Pembrolizumab|
16028724|NCT02675933|Behavioral|Questionnaire|There will be a single page document, a patient-centered questionnaire, distributed to parents of study participants who have been randomized to the intervention arm.
16028725|NCT02675920|Drug|non-ionic monomer iodinated CT contrast media|patients underwent contrast-enhanced CT using aforementioned CT contrast media (non-ionic monomer iodinated CT contrast media)
16028726|NCT02675907|Drug|N1539|
16028727|NCT02675907|Drug|Intravenous Placebo|
16028728|NCT02675894|Device|cooled-wet electrode|RFA is performed using three cooled-wet electrodes in switching bipolar mode. The electrode is anticipated to reduce tissue resistance by releasing small amount of saline during the procedure, which may lead larger ablative volume by delivering more RF energy.
16028729|NCT02675894|Device|separable clustered electrode|RFA is performed using separable clustered electrode in switching monopolar mode.
16028730|NCT02675881|Device|DSM|Monopolar RFA using dual switching mode (DSM)
16028731|NCT02675881|Device|separable clustered electrode|A separable clustered electrode is similar to a clustered electrode, although it differs from a conventional clustered electrode in that each individual electrode is separable.
16028732|NCT02675868|Drug|Norepinephrine|Noradrenaline is an endogenous catecholamine with sympathomimetic effects. It has mainly α-adrenergic receptor selectivity but also β-effects in higher concentrations. It will be administered at 0.05 μg/kg/min, a clinical relevant dose on the low end of the scale.
16028733|NCT02675868|Drug|Phenylephrine|Phenylephrine is a selective α-adrenergic receptor agonist. It will be administered at 0.5 μg/kg/min, based on its relative vasopressor potency in comparison with noradrenaline.
16028734|NCT02675868|Drug|Vasopressins|Vasopressin is 8-arginine-vasopressin, a synthetic analogue of endogenous nonapeptide hormone. It exerts its action via V1 receptors (ubiquitous vasoconstriction) and V2 receptors (renal water resorption). It will be administered at 0.04 IU/min, a clinically relevant dose.
16028735|NCT02675868|Drug|Placebo|NaCl 0.9% infusion
16028957|NCT02674243|Drug|Iodopovidone solution|In this group, iodopovidone solution will be used as pleurodesis substance
16028736|NCT02675855|Other|GrafixPRIME®|Human tissue, Wound cover, Application of a non-adherent dressing, a moisture retentive dressing, and a secondary dressing.
16028737|NCT02675855|Procedure|Dressing Application|Wound cover, Application of a non-adherent dressing, a moisture retentive dressing, and a secondary dressing.
16028738|NCT02675855|Device|Off-loading (walking boot)|Patients will be fitted for an off-loading device (walking boot) and agree to comply with use of the device during the course of the study
16028739|NCT02675842|Drug|Smoked Cannabis High CBD/low THC|Participants will visit the research laboratory 3-5 days a week over 6 weeks to be administered 1-2 Cannabis cigarettes (15.76% CBD; 3.11% -9-THC) over the course of 2-3 hours.
16028740|NCT02675842|Drug|Smoked Placebo Cannabis Low CBD/low THC|Participants will visit the research laboratory 3-5 days a week over 6 weeks to be administered 1-2 Cannabis cigarettes Cannabis (0.0% CBD/ 0.01% -9-THC) over the course of 2-3 hours.
16028741|NCT02675829|Drug|ado-trastuzumab emtansine|Ado-trastuzumab emtansine is administered intravenously at 3.6 mg/kg every 21 days (unless dose reduction and/or dose delays are required) until disease progression or unacceptable toxicity.
16028742|NCT02675816|Device|Inspire® Upper Airway Stimulation (UAS) System|This is a single-arm study; all participants will be implanted with the Inspire® Upper Airway Stimulation (UAS) System. This is a permanent, implantable therapy device, which consists of three implantable components: an implantable pulse generator (IPG), a stimulation lead, and a sensing lead. In addition, the patient receives a handheld remote to activate the therapy
16028743|NCT02675803|Biological|VAY736|VAY736 treatment
16028744|NCT02675803|Biological|VAY736 placebo|VAY736 placebo
16028745|NCT02675790|Drug|Moderate Dose Hydroxyurea|Hydroxyurea therapy at 20 mg/kg/day for primary stroke prevention.
16028746|NCT02675790|Drug|Low Dose Hydroxyurea|Hydroxyurea therapy at 10 mg/kg/day (range 7 - 15 mg/kg/day) for primary stroke prevention.
16028747|NCT02675777|Other|Quality Improvement Intervention|"Group Health clinical leaders and clinicians implement all aspects of behavioral health integration (screening, assessment, and shared decision-making followed by treatment). The implementation strategy, which was refined during the pilot phase, will include:
~Identification of a clinical champion and Local Implementation Team.
~Participatory Design.
~Training primary care providers and Medical Assistants.
~EHR clinical decision support tools
~Weekly facilitated Local Implementation Team meetings.
~Performance monitoring with feedback, including monthly PDCA meetings with the Local Implementation Team and clinic leaders.
~Learning sessions for primary care providers during implementation.
~Social worker use of an EHR registry with weekly supervision.
~Video and handout explicitly designed to shift attitudes about unhealthy alcohol use (overcoming misconceptions and stigma)"
16028748|NCT02675764|Other|Vibration|peripheral vibration at the wrist skin at an imperceptible level
16028749|NCT02675764|Other|Placebo (for vibration)|No peripheral vibration at the wrist skin
16028750|NCT02675764|Behavioral|therapy|standardized hand therapy program
16028751|NCT02675751|Device|STAR S4 IR laser with iDesign|Surgeons will perform wavefront-guided PRK for the treatment of myopic refractive errors based upon measurements obtained with the iDesign System using the STAR S4 IR laser.
16028752|NCT02675738|Other|good clinical practice|
16028753|NCT02675725|Device|Measurement of sublingual microcirculation with Cytocam-IDF camera|"The normal treatment of a post-cardiac surgery patient is fluid bolus by indication. This indications are hypotension, hyperlactataemia, tachycardia or decreased urine production. This fluid bolus is 250 ml crystalloids in 15 minutes.
~When this fluid bolus will be given, the investigators will observe the sublingual microcirculation and measure the red blood cell velocity and total vessel density on one spot for 20 minutes."
16028754|NCT02675712|Other|African drumming|Rhythmic beating or tapping of a variety of percussion instruments, which often occurs within a group setting
16028755|NCT02675699|Behavioral|Optimisation + HENRY|"HENRY HENRY is an 8-week childhood obesity prevention programme delivered in Children's Centres in the UK by trained practitioners, aiming to provide parents with skills and knowledge to support healthy lifestyles in preschool children and their families. The programme aims to build parents' skills, knowledge and confidence to change old habits and provide healthier nutrition.
~OPTIMISATION A tailored 'Optimisation' intervention has being developed to support local authorities and Children's Centres to promote HENRY implementation, based on an ethnography of Children Centres, including interviews with staff and other stakeholders and input from parents. Development was underpinned by strong theories of behaviour change and will be guided by the intervention planning framework; the Behaviour Change wheel using a systematic approach. Strategies have been developed to improve parent motivation to enrol on to HENRY and promote parent self-efficacy to continue to attend."
16028756|NCT02675699|Behavioral|HENRY as standard|Local Authorities / Children's Centres that are assigned to the control group will continue with standard HENRY practice. Current HENRY QA practice involves the review of process data by HENRY central office with provision of written and oral feedback. This will continue in both trial arms and will be monitored.
16028757|NCT02675673|Procedure|GJ-Tube|Insertion of a GJ tube either prior to the start of radiotherapy or within the first 2 weeks after the first dosage.
16028758|NCT02675673|Procedure|G-Tube|Insertion of a G-tube either prior to the start of radiotherapy or within the first 2 weeks after the first dosage.
16028759|NCT02675660|Dietary Supplement|L-Homoarginine|125 mg L-homoarginine once daily
16028760|NCT02675660|Drug|Placebo|placebo capsules once daily
16028761|NCT02675647|Drug|Heparin, IV route, based on patients body weights (UI/kg)|
16028762|NCT02675647|Procedure|Cardiopulmonary bypass|
16028763|NCT02675647|Drug|Protamin administration|
16028764|NCT02675634|Device|Coloplast Test A|Test A is a new 1-piece ostomy appliance developed by Coloplast A/S
16028765|NCT02675634|Device|Coloplast Test B|Test B is a new 1-piece ostomy appliance developed by Coloplast A/S
16028766|NCT02675634|Device|Subjects own product|The comparator product is the ostomy appliance product that the subject normally uses. This could include products like SenSura , SenSura Mio, Confidence Natural, Moderma Flex and many more. data from the subject own product will be pooled so they appear as one comparator group.
16028767|NCT02675621|Other|Phenolic Beverage|
16028768|NCT02675608|Biological|Influenza Virus Vaccine|On the first visit, subjects are vaccinated with the 2015-2016 seasonal flu vaccine.
16028769|NCT02675582|Other|Herbal Beverage|Intervention involves consuming one beverage at the beginning of each visit during the incomplete block design sequence
16028770|NCT02675569|Procedure|Catheter|A method of vascular access for hemodialysis that all participants will have in place prior to randomization.
16028771|NCT02675569|Procedure|Fistula|A type of vascular access strategy for hemodialysis which involves connecting the artery and the veins in the participant's arm.
16028772|NCT02675556|Drug|Allo-hMSCs|a single administration of allogeneic Human Mesenchymal Stem Cell (hMSCs): 100 x 10^6 (100 million) allo-hMSCs of cells
16028773|NCT02675556|Drug|Placebo|a placebo administration consisting of 1% human albumin serum in Plasma-Lyte A
16028774|NCT02675543|Device|Vitreous Tamponade with Silicone Oil|
16028775|NCT02675530|Drug|ketamine|"For healthy volunteer arm of study, NMDA antagonist ketamine will be administered. 0.23 mg/kg over 1 minute, followed by 0.58 mg/kg/hour for 30 minutes, followed by 0.29 mg/kg/hour for 50 minutes.
~No drug administration for patients with schizophrenia"
16028776|NCT02675517|Drug|Spiolto Respimat|Tiotropium bromide + Olodaterol
16028777|NCT02675504|Other|Placing a scale self-assessment of fear|Children spend a self-assessment scale of fear
16028778|NCT02675491|Drug|DS-6051b|Drug: DS-6051b 400 mg or 800 mg daily
16028779|NCT02675478|Drug|AC220|
16028782|NCT02675452|Drug|AMG 176|Study Drug
16028783|NCT02675452|Drug|Azacitidine|Non-investigational product
16028784|NCT02675452|Drug|Itraconazole|Non-investigational product
16028785|NCT02675439|Drug|ADU-S100|
16028786|NCT02675439|Biological|ipilimumab|
16028787|NCT02675426|Drug|Placebo|Tablet; Oral
16028788|NCT02675426|Drug|Upadacitinib|Tablet; Oral
16028789|NCT02675413|Drug|Dimethyl Fumarate|Open-label
16028790|NCT02675400|Drug|Vyvanse|Half of the participants (fathers) will be randomized to receive Vyvanse.
16028791|NCT02675400|Behavioral|Behavioral Parent Training|Half of the fathers will receive behavioral parent training.
16028792|NCT02675400|Drug|Methylphenidate|If Vyvanse is not well tolerated, methylphenidate can be prescribed.
16028793|NCT02675387|Device|Buzzy|Two minute application of a hand held vibrating device (Buzzy, MMJ labs, Atlanta GA, USA) before the administration of anesthesia
16028794|NCT02675387|Drug|2%Lidocaine|1.8ml of 2%Lidocaine HCl to be administered via a 21mm needle (30 Guage)
16028795|NCT02675374|Drug|dexchlorpheniramine (Polaramine®) injection|5 minutes before CPB, patients will receive 10 mg (2 ml) of Polaramine®
16028796|NCT02675374|Drug|Placebo injection|5 minutes before CPB, patients will receive 2 ml of normal saline
16028797|NCT02675361|Behavioral|Transition program|Participants will be part of a transition program with eight key components: 1. A transition coordinator; 2. Education on congenital heart disease (CHD), treatments, health behavior, dealing with school, friends; 3. Telephone availability; 4. Information about the Grown-Up Congenital Heart Disease (GUCH) program: 5. Guidance of parents; 6. Meeting with peers: 7. A person-centered transition plan; and 8. Transfer to Grown-Up Congenital Heart Disease clinic. The intervention will be implemented by specialized nurses at the outpatient clinic of pediatric cardiology. Overall, 60 to 90 minutes per patient are spent over the 2.5 years.
16028798|NCT02675348|Dietary Supplement|Dietary Supplement: Beef Protein|Participants will combine a 10-week periodized and controlled endurance programme with the ingestion of beef protein supplement after training. Measurements pre and post intervention will be endurance performance (vo2max) and blood markers: haemoglobin; red blood cell; erythrocyte; haematocrit; mean corpuscular volume, transferrin; neutrophils; lymphocyte; monocytes
16028799|NCT02675348|Dietary Supplement|Dietary Supplement: whey Protein|Participants will combine a 10-week periodized and controlled endurance programme with the ingestion of whey protein supplement after training. Measurements pre and post intervention will be endurance performance (vo2max) and blood markers: haemoglobin; red blood cell; erythrocyte; haematocrit; mean corpuscular volume, transferrin; neutrophils; lymphocyte; monocytes
16028800|NCT02675348|Dietary Supplement|Dietary Supplement: CHO|Participants will combine a 10-week periodized and controlled endurance programme with the ingestion of maltdextrin after training. Measurements pre and post intervention will be endurance performance (vo2max) and blood markers: haemoglobin; red blood cell; erythrocyte; haematocrit; mean corpuscular volume, transferrin; neutrophils; lymphocyte; monocytes
16028801|NCT02675335|Drug|Sitagliptin|
16028802|NCT02675335|Drug|Placebo|
16028803|NCT02675322|Drug|Danlou Tablets|Danlou tablets were approved by China Food and Drug Administration for the treatment of ischemic heart disease in 2005 (Z20050244).
16028804|NCT02675322|Other|Placebo|Placebo with no chemical effects.
16028805|NCT02675309|Drug|MT-8554|
16028806|NCT02675309|Drug|rosuvastatin|
16028807|NCT02675309|Drug|simvastatin|
16028808|NCT02675283|Device|Simtomax|Patients will undertake a finger prick point of care test, Simtomax, at the pharmacy. A sample of 25 μl of capillary venous blood is required which can be obtained through a simple finger prick technique. The sample is then applied to the test device, followed by the application of 5 drops of the provided buffer solution. The result can be read after 10 minutes. Positive results are indicated by the presence of a solid red line, with a single line for a combined IgA and IgG DGP positivity, and a single line for the presence of total IgA. An in-built control line ensures a correctly functioning test.
16028809|NCT02675270|Behavioral|Phonological|This treatment involves picture viewing and word repetition.
16028810|NCT02675270|Behavioral|Orthographic|This treatment involves picture viewing, reading, and writing.
16028811|NCT02675270|Behavioral|Semantic|This treatment involves learning about the semantic features (meaning) of each trained word.
16028812|NCT02675270|Behavioral|Lexical|This treatment involves learning about the lexical features (letters and sounds) of each trained word.
16028813|NCT02675270|Behavioral|Untrained|These words are not trained during the treatment phase.
16028814|NCT02675257|Behavioral|Diabetes-related affective problems analysis|Analysis of diabetes-related affective problems with regard to suboptimal glycaemic control
16028815|NCT02675257|Behavioral|Goal setting towards improvement of glycaemic control|Discussing and setting goals regarding improvements of suboptimal glycaemic control, depressive symptoms and diabetes distress
16028816|NCT02675257|Behavioral|Diabetes-specific problem-solving therapy|Diabetes-specific problem-solving therapy with main focus on suboptimal glycaemic control, depressive symptoms and diabetes distress
16028817|NCT02675257|Behavioral|Interventions to increase diabetes treatment motivation|Interventions to increase diabetes treatment motivation in order to achieve improvements of glycaemic control as well as recovery from affective problems
16028818|NCT02675257|Behavioral|Activation of personal and social resources|Activation of personal and social resources with a view to diabetes control and affective problems
16028819|NCT02675257|Behavioral|Reduction of barriers to self-care/glycaemic control|Definition and reduction of barriers to adequate diabetes self-care behaviour as well as good glycaemic control
16028820|NCT02675257|Behavioral|Cognitive restructuring of diabetes-related problems|Cognitive restructuring of diabetes-related problems such as suboptimal glycaemic control and diabetes-related affective problems
16028821|NCT02675257|Behavioral|Goal definition regarding self-care/glycaemia/well-being|Goal definition and agreement regarding diabetes self-care behaviour, optimal glycaemic control and activities supporting well-being and recovery from affective symptoms
16028822|NCT02675257|Behavioral|Health care and specific topics (e. g. blood pressure)|Education on health care and specific topics (e. g. blood pressure)
16028823|NCT02675257|Behavioral|Healthy foods, cooking recommendations, recipes|Education on healthy and unhealthy foods, cooking and recipes
16028824|NCT02675257|Behavioral|Sports, activities and exercise|Education on sports, activities and exercise
16028825|NCT02675257|Behavioral|Foot care: exercises, care & control, injuries, neuropathy|Education on foot care: exercises, care and control, injuries, and diabetic neuropathy
16028826|NCT02675257|Behavioral|Diabetes complications|Education on diabetes complications
16028827|NCT02675257|Behavioral|Social aspects of living with diabetes|Education on social aspects of living with diabetes
16028830|NCT02675231|Drug|Abemaciclib|Administered Orally
16028831|NCT02675231|Drug|Trastuzumab|Administered IV
16028832|NCT02675231|Drug|Fulvestrant|Administered IM
16028833|NCT02675231|Drug|Standard of Care Single Agent Chemotherapy|Standard-of-care single-agent chemotherapy of physician's choice administered according to product label
16028834|NCT02675218|Other|Patients with rheumatoid arthritis|Doppler effect at 3 months after Abatacept treatment initiation.
16028835|NCT02675205|Drug|Clopidogrel|clopidogrel: efficacy and safety in cerebral aneurysm stenting
16028836|NCT02675205|Drug|Ticagrelor|ticagrelor:efficacy and safety in cerebral aneurysm stenting
16028837|NCT02675205|Drug|aspirin|
16028838|NCT02675192|Other|Proof cohort : muscular assessment|Clinical examination, blood appraisal, urinary collection, MVC, checking muscle functional skills and muscular biopsy will be performed.
16028839|NCT02675179|Device|EOS|Pelvimetry will be performed with the new EOS technique of diagnosis to measure the diameter of the basin.
16028840|NCT02675179|Device|Spiral CT pelvimetry|Pelvimetry will be performed with the spiral CT technique. It is the technique usually used.
16028841|NCT02675166|Other|Pediatric cancer young adult survivors|Patients will receive a questionnaire, a consultation with an oncologist and a psychologist will be planned, and two years later, patients will have to answer again to the questionnaire.
16028842|NCT02675153|Drug|Rapamycin|Participants with gastrointestinal strictures were treated with rapamycin 2mg daily at least six months.
16028843|NCT02675140|Drug|ZENTEL|Children in Group 2 (n=62) received 400 mg single-dose albendazole (helmintic treatment)
16028844|NCT02675140|Drug|ZENTEL and Vitamin A Soft Capsules|Children in Group 3 (n=60) received a 200,000 IU vitamin A capsule combined with 400 mg single-dose albendazole once initially
16028845|NCT02675127|Drug|Daktavira|1 tablet contains 60 mg Daclatasvir
16028846|NCT02675127|Drug|Daklinza|1 tablet contains 60 mg Daclatasvir
16028847|NCT02675114|Procedure|Surgical aortic valve replacement (SAVR)|SAVR with a commercially available bioprosthetic valve.
16028848|NCT02675114|Device|SAPIEN 3 THV|TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System
16028849|NCT02675101|Other|Whole Nuts|Participants will be advised on maintaining an iso-caloric diet. Aside consuming nuts, the remaining composition of the prescribed diet will be based on individual preferences. During the 6-month intervention, study subjects will meet with study staff every 2-3 weeks to weigh in, pick up food supplies and complete a questionnaire on compliance. All participants will have contact with the project coordinator/study dietitian a minimum of every 1-2 weeks either in-person, telephone, email and text message contacts for support, behavioral guidance and strategies. Both walnuts and almonds will be provided to participants in the whole nut study arm.
16028850|NCT02675101|Other|Olestra: Fat Free Pringles|Participants will be advised on maintaining an iso-caloric diet. Aside consuming fat free potato crisps, the remaining composition of the prescribed diet will be based on individual preferences. During the 6-month intervention, study subjects will meet with study staff every 2-3 weeks to weigh in, pick up food supplies and complete a questionnaire on compliance. All participants will have contact with the project coordinator/study dietitian a minimum of every 1-2 weeks either in-person, telephone, email and text message contacts for support, behavioral guidance and strategies. Fat Free Pringles will be provided to participants in the olestra study arm.
16028851|NCT02675101|Other|Vegetable Oil: Original Pringles|Participants will be advised on maintaining an iso-caloric diet. Aside consuming potato crisps, the remaining composition of the prescribed diet will be based on individual preferences. During the 6-month intervention, study subjects will meet with study staff every 2-3 weeks to weigh in, pick up food supplies and complete a questionnaire on compliance. All participants will have contact with the project coordinator/study dietitian a minimum of every 1-2 weeks either in-person, telephone, email and text message contacts for support, behavioral guidance and strategies. Original Pringles will be provided to participants in the vegetable oil study arm.
16028852|NCT02675088|Radiation|high-dose TRT|every day, Monday-Friday, for a total of 3 weeks, 45 Gy/ 3 Gy/ 15 f
16028853|NCT02675088|Radiation|standard-dose TRT|every day, Monday-Friday, for a total of 2 weeks, 30 Gy/ 3 Gy/ 10 f
16028854|NCT02675049|Drug|0.9% saline|0.9% saline intranasally 45 min before surgery using a computer-generated random number table.
16028855|NCT02675049|Drug|dexmedetomidine 1µg.kg-1|dexmedetomidine 1µg.kg-1 intranasally 45 min before surgery using a computer-generated random number table.
16135134|NCT01896349|Drug|Imipramine|
16028856|NCT02675049|Drug|dexmedetomidine 1.5µg.kg-1|Dexmedetomidine 1.5µg.kg-1 intranasally 45 min before surgery using a computer-generated random number table.
16028857|NCT02675049|Drug|Dexmedetomidine 2µg.kg-1|dexmedetomidine 2µg.kg-1 intranasally 45 min before surgery using a computer-generated random number table.
16028858|NCT02675036|Procedure|Tooth extraction|
16028859|NCT02675023|Biological|M923|Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)
16028860|NCT02675010|Other|ENDOSCOPIC GASTRIC BIOPSIES FROM ANTRUM AND BODY|ENDOSCOPIC GASTRIC BIOPSIES FROM ANTRUM AND BODY
16028861|NCT02674997|Biological|Factor VIII|Licensed Factor VIII products. Study is brand agnostic
16028862|NCT02674971|Behavioral|Common components of intervention|12-week standard lifestyle intervention for obesity, which consists of weekly meetings. Each meeting will last 60 minutes, with participants attending group meetings specific for their condition. In all meetings, participants will be weighed, homework assignments will be verbally reviewed, and a behavioral lesson will be presented. Basic behavioral lessons, will be similar to those that have been successfully used in the Diabetes Prevention Program (DPP) and Look AHEAD. Topics to be covered in the meetings will focus on the dietary prescriptions and dietary information for each condition, the physical activity goal, energy balance, and behavioral strategies. Each session will conclude with reminding participants of their dietary and physical activity goals, and having participants self-monitor these behaviors every day and implement the behavioral strategies discussed in the session.
16028863|NCT02674958|Drug|Aspirin|Aspirin 325mg bolus followed by 162mg daily until day 7 post alcohol septal ablation
16028864|NCT02674945|Device|Wireless Activity tracker: Fitbit|Patients will wear a Fitbit flex
16028865|NCT02674932|Behavioral|Identifying and Using Signature Strengths|The purpose of the intervention is to identify and focus on one's morally valued strengths and utilize them (i.e. incorporate them into coping skills) to overcome challenges. The study team member and patient will discuss each top strength and ways to use them as coping skills. The patient will identify 2-4 coping mechanisms per strength, and will write his/her strengths and self-identified coping skills on index cards.
16028866|NCT02674932|Behavioral|Identifying and Writing Down Coping Skills|The study team member and patient will discuss the importance of having coping skills to deal with stressful and difficult situations. The patient will then identify at least six coping skills and write them down on index cards.
16028867|NCT02674932|Behavioral|Treatment as Usual|The study team member and patient will discuss the importance of having coping skills to deal with stressful and difficult situations. The patient will then identify coping skills that could be helpful (but will not write them down).
16028868|NCT02674919|Other|Nordic Hamstring|
16028869|NCT02674919|Other|Control|
16028870|NCT02674906|Drug|ACD-A|use of ACD-A as anticoagulant after blood salvage during cardiac surgery
16028871|NCT02674906|Drug|Heparin|use of heparin as anticoagulant after blood salvage during cardiac surgery
16028872|NCT02674893|Drug|Liraglutide|
16028873|NCT02674893|Other|Observation alone|
16028874|NCT02674880|Drug|HMW-HA|Aerolized administration b.i.d.
16028875|NCT02674880|Other|Placebo|Standard therapy
16028876|NCT02674867|Other|Blood draw|
16028877|NCT02674854|Drug|PG324 Ophthalmic Solution 0.02%/0.005%|1 drop daily in the evening (PM) in both eyes (OU)
16028878|NCT02674854|Drug|Netarsudil (AR-13324) ophthalmic solution 0.02%|1 drop daily in the evening (PM) in both eyes (OU)
16028879|NCT02674854|Drug|Latanoprost ophthalmic solution 0.005%|1 drop daily in the evening (PM) in both eyes (OU)
16028880|NCT02674841|Other|Feedback on TUT|Access to live visual and auditory feedback on TUT and pulling force from an application on an iPad.
16028881|NCT02674841|Other|No feedback on TUT|Access only to live visual feedback on pulling force from an application on an iPad.
16028882|NCT02674841|Other|Exercise|3 exercises (knee extension, hip abduction and hip extension) using an elastic band with 3 sets of 10 repetitions at 10-12 RM 3 times a week for 6 weeks.
16028883|NCT02674828|Behavioral|Reinforcement for meeting targeted physical activity goals|Participants in this condition will receive reinforcement for meeting targeted physical activity goals. These subjects will receive the same treatment as standard treatment group, including incentives for uploading/synching and discussions of ADA recommendations of managing diabetes in the context of physical activity. The only difference between conditions is that participants in this condition will earn tangible reinforcement for walking the target number of steps per day (6,000 per day in week 1, 8,000 per day in week 2 and 10,000 per day in weeks 3-12). At each upload, participants will earn incentives for each day on which they met the step goals. In addition, for each 7-day period in which they meet goals on at least 5 days, they will earn bonuses.
16028884|NCT02674828|Other|Standard of Care|Participants in the standard of care group will be told to wear Fitbit daily for 12 weeks. They will be instructed to upload or synch it >2x/week, on set days, e.g., Mon and Thurs, for the next 6 weeks and then weekly in the last 6 weeks. They will receive incentives for each upload, plus a bonus for each week in which data are registered for all 7 days in the week as scheduled. They will be encouraged to review Fitbit steps daily and on each upload/synch day. After each upload, research staff will congratulate patients via email or text for days on which they met goals, and encourage meeting goals in the upcoming week.
16028885|NCT02674815|Other|High Intensity Interval Training Exercise programme|High intensity interval training (HIIT) requires participants to exercise at high levels of VO2peak (≥80% VO2peak). Participants exercise for short periods (e.g. 15-30 seconds) followed by periods of rest (active or passive) and typically continue this pattern for a set time period or until exhaustion.
16028886|NCT02674789|Behavioral|Exercise protocol|70% VO2max bike ergometer test for 90 minutes
16028887|NCT02674776|Drug|HuZhen Capsule|Patients should take 4 tablet once and 3 times per day for 3 days.
16028888|NCT02674776|Drug|Placebo Capsule|Patients should take 4 tablet once and 3 times per day for 3 days.
16028889|NCT02674763|Drug|IMGN779|
16028890|NCT02674750|Drug|CUDC-907|
16028891|NCT02674737|Drug|dexmedetomidine, tramadol and flurbiprofen|
16028892|NCT02674737|Drug|tramadol and flurbiprofen|
16028955|NCT02674256|Drug|CRH|100µg CRH powder for injection (CRH ferring®, Ferring, Aalst, Belgium) and 1 mL of NaCl 0.9% will be put together, then the solution will be injected intravenously over the course of 1 minute
16030199|NCT02664779|Other|Arrhythmia diagnosis with the 6 steps method|
16028893|NCT02674724|Other|Gym Group|"Patients from Gym Group will perform a strengthening program of 45 minutes sessions, twice a week in a 12-week period.
~The initial load is established as 60% of one-repetition maximum strength test (1RM) applied for each exercise at the beginning of program. Patients will be encouraged to perform 3 sets of 8 to 12 repetitions. All subjects will be instructed to rest for 30-60 second intervals between sets."
16028894|NCT02674724|Other|Free Weights Group|Patients from Free Weights Group will perform a strengthening program of 45 minutes sessions, twice a week in a 12-week period. The program aim to recruit the same muscles requested in Gym Group. Investigators will apply six different exercises with patients lying supine,standing in stance, sitting and in four points kneeling. All exercises aim to strengthen abdominal muscles, trunk extensors, gluteus, quadriceps and scapula adductors. Patients will perform 3 sets of 8 to 12 repetitions, the load will be offered with dumbbells, elastics with different resistances and anklets.
16028895|NCT02674724|Other|Control Group|All three groups will be instructed to perform stretching exercises of trunk, leg and shoulder muscles, according to an illustrated booklet. Only the Control Group patients will be instructed to perform stretching exercises at home in the same 12-week period.
16028896|NCT02674711|Behavioral|Educational Video|The content of the education focus on providing a historical perspective for opioid prescription from the time when the risk of dependence was highly underestimated. The video discusses the current evidence for the effect of opioid medications in non-cancer non-acute pain. It also discusses some of the dangers of long-term opioid usage. The video is 11 and ½ minutes long.
16028897|NCT02674698|Other|Access to the CNH Dashboard Step 1|VA Integrated Service Networks will be provided education on nursing home quality and access to the CNH Dashboard
16028898|NCT02674698|Other|Access to the CNH Dashboard Step 2|VA Integrated Service Networks will be provided education on nursing home quality and access to the CNH Dashboard
16028899|NCT02674698|Other|Access to the CNH Dashboard Step 3|VA Integrated Service Networks will be provided education on nursing home quality and access to the CNH Dashboard
16028900|NCT02674698|Other|Access to the CNH Dashboard Step 4|VA Integrated Service Networks will be provided education on nursing home quality and access to the CNH Dashboard
16028901|NCT02674672|Device|VenaTech® (VenaTech Retrievable Filter)|
16028902|NCT02674659|Behavioral|resistance training|resistance training consists of lower and upper extremities exercises. We focus on biceps and hamstring to be trained. One session was held for around 30 minutes.
16028903|NCT02674659|Behavioral|aerobic training|aerobic exercise consists of warming up session, treadmill exercise (around 20-30 minutes), and wrap-up session (for all session about 1 hour)
16028904|NCT02674646|Radiation|Radiotherapy|Radiation as indicated by the cancer diagnosis
16028905|NCT02674646|Device|Needle Acupuncture|Needle Acupuncture according to Traditional Chinese Medicine (TCM)
16028906|NCT02674633|Device|AKL-T01|Videogame-like digital therapy
16028907|NCT02674633|Device|AKL-T09|Videogame-like digital therapy
16028908|NCT02674620|Other|Aerobic Exercise|Patients are treated with progressive exercise
16028909|NCT02674607|Dietary Supplement|Spirulina|
16028910|NCT02674581|Drug|Oral BMS-663068 (pro-drug)|Oral BMS-663068 (pro-drug), metabolized to active BMS-626529
16028911|NCT02674568|Drug|Rovalpituzumab tesirine|Rovalpituzumab tesirine is a DLL3 targeted antibody drug conjugate (ADC).
16028912|NCT02674555|Drug|radio-labeled naquotinib|Oral administration
16028913|NCT02674555|Drug|naquotinib|Oral administration
16028914|NCT02674542|Other|In-depth interviews|"Future family planning intentions and beliefs
~Family planning experiences and beliefs:
~Feasibility and acceptability of birth spacing promotion for women who experienced a still birth or early neonatal demise"
16028915|NCT02674542|Other|Focus Group|"Future family planning intentions and beliefs
~Family planning experiences and beliefs:
~Feasibility and acceptability of birth spacing promotion for women who have experienced a stillbirth or early neonatal demise"
16028916|NCT02674529|Drug|Escitalopram|Selective Serotonin Reuptake Inhibitor (SSRI)
16028917|NCT02674529|Drug|Placebo|Placebo
16028918|NCT02674516|Device|Transcranial direct current stimulation|
16028919|NCT02674516|Device|Sham transcranial direct current stimulation|
16028920|NCT02674503|Behavioral|Walking|MP patients will participate in a program of progressive walking and transfer training up to three times a day, seven days a week throughout the hospital stay. MP patients will begin with assisted sitting, then standing, progressing to weight shifting and stepping in place, and then to walking as tolerated. The level of mobility recommended to the MP patient by the Walker will be dependent on the individual patient and will incorporate the activities patients were deemed able to do independent of cueing or assistance during each walking session.
16028921|NCT02674503|Behavioral|Friendly visit|"UC patients will receive three times a day friendly visits, seven days a week by members of the research team to control for the daily attention that MP patients receive."
16028922|NCT02674490|Device|A-tDCS (1 mA)|1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. A-tDCS stimulation will be active only in the first 20 minutes of the 45-minute treatment session.
16028923|NCT02674490|Behavioral|SALT|Computer-delivered naming treatment requires matching word (heard and seen being produced by the speaker) with pictures depicting common objects. It is run on a laptop computer with headphones and 2 large response buttons. During treatment, a picture appears on the laptop screen for 2 seconds. Then, a video of the speaker's face below the nose is presented on the screen saying a word that either matches or does not match the picture. The participant is instructed to press a green response button if the word matches the picture and press the red response button if the word does not match the picture.
16028924|NCT02674490|Device|Sham|1 mA of A-tDCS stimulation is induced between two 5 cm x 5 cm saline soaked sponges where one sponge (anode: A-tDCS) is placed on the scalp over the targeted cortical region. Ramping up of the current to 1 mA occurs over 10-15 seconds to allow participants to habituate to the tingling sensation. Then, the current will be ramped back down to 0 mA in the sham condition. Termination of the stimulation after the ramping up process is generally undetectable, and the brief duration of stimulation yields no functional effects.
16028956|NCT02674256|Other|Placebo|1 mL of NaCl 0.9% will be injected intravenously over the course of one minute
16135135|NCT01896349|Drug|amitriptyline|
16028925|NCT02674477|Device|Therapeutic Education System (TES)|The TES program is made of modules about ways to prevent substance use, such as how to refuse drugs and alcohol, how to cope with thoughts about using, and how to make the best possible decisions for a person's mental health. Each module takes less than 30 minutes to complete. Modules may contain videos or other interactive media. At the end of each module, there are questions about the material.
16028926|NCT02674477|Other|Treatment as Usual (TAU)|Standard treatment comprises a psychiatrist-led interdisciplinary team as well as face-to-face group counseling for substance use and skills for improving general mental health. There will be no change to the routine care (treatment at usual [TAU]) provided to patients on the service.
16028933|NCT02674451|Procedure|Remote ischemic preconditioning|Blood pressure cuff inflation to 200 mmHG for three 5-minute periods each separated by 5 minute intervals within 1 hour of planned coronary angiography.
16028934|NCT02674438|Other|Risk stratification and transitional care intervention|"Intervention consists of 2 components:
~Risk stratification: Determination of risk using the EHMRG 7-day and 30-day risk scores, where decision to admit, observe, or discharge the patient will be guided by the result of the risk scores
~Transitional care: Follow-up care in the RAPID-HF transitional care clinic begins at 48 hours after emergency department or hospital discharge. Care provided by cardiologist + nurse for up to 30 days after emergency department or hospital discharge."
16028935|NCT02674425|Device|Dark Adaptometer|
16028936|NCT02674412|Drug|Buspirone|
16028937|NCT02674412|Drug|Placebo|Placebo Pill Manufactured by the Investigational Pharmacy at Cleveland Clinic
16028938|NCT02674399|Drug|JointStem|
16028939|NCT02674399|Drug|Synvisc-One|
16028940|NCT02674386|Drug|Investigational Medical Product (IMP) administered in parent study|IMP as administered in parent study. IMP would have been either placebo, tanezumab, celecoxib, naproxen or diclofenac administered in parent study.
16028941|NCT02674360|Behavioral|SDM Training|
16028942|NCT02674347|Drug|3 g or 6 g Zidebactam|IV for over a duration of 60 minutes
16028943|NCT02674347|Drug|Placebo|IV matching the Investigational drug
16028944|NCT02674334|Device|NIRS|Near infrared spectroscopy (NIRS) monitor allows anesthesiologist to treat cerebral desaturations according to NIRS results while maintaining Mean Arterial Pressure (MAP) at least 60mmHG or at least 80% of baseline
16028945|NCT02674334|Device|NIRS monitored not treated|Near infrared spectroscopy (NIRS) monitored but anesthesiologist blinded to NIRS information and treatment is standard of care.
16028946|NCT02674321|Drug|SD-809|
16028947|NCT02674308|Drug|Vedolizumab|
16028948|NCT02674308|Other|Other Biologic Agents|Other biologic agents include: Adalimumab, Certolizumab pegol, Golimumab, and Infliximab
16028949|NCT02674295|Drug|Esketamine 50 mg|50 mg of oral esketamine, fortified with a microtracer dose of 14C-esketamine, as an aqueous solution mixed with apple juice for administration (80 mL total volume)
16028950|NCT02674295|Drug|Esketamine 20 mg|20 mg of intravenous esketamine in 30 mL, fortified with a microtracer dose of 14C-esketamine, as a 30-minute intravenous infusion.
16028951|NCT02674282|Procedure|ACL reconstruction|ACL reconstruction with hamstrings autograft.
16028952|NCT02674269|Drug|300 IU of BotuGelTM (60ml)|One intravesical instillation of 300 IU of botox in 60 ml of TC-3 gel
16028953|NCT02674269|Drug|400 IU of BotuGelTM (60ml)|One intravesical instillation of 400 IU of botox in 60 ml of TC-3 gel
16028954|NCT02674269|Device|TC-3 Gel|Intravesical instillation of 60 ml TC-3 gel
16028958|NCT02674243|Drug|Talc|In this group, Talc will be used as pleurodesis substance
16028959|NCT02674217|Procedure|Hematopoietic stem cell transplantation|autologous transplant using non-frozen peripheral blood stem cells
16028960|NCT02674204|Drug|Atorvastatin|Atorvastatin calcium, a synthetic lipid-lowering agent, is an inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase. This enzyme catalyzes the conversion of HMG-CoA to mevalonate, an early and rate-limiting step in cholesterol biosynthesis.
16028961|NCT02674204|Drug|Placebo|A substance that has no therapeutic effect, and will be used as a control in testing the study agent.
16028962|NCT02674191|Device|mini-plates supported molar intrusion|(Stryker, Leibinger, GmbH& Co., Freiburg, Germany) for molar intrusion using miniplates to treat hyperdivergent adolescence
16028963|NCT02674191|Procedure|Application of ULTRACARE benzocaine 20%,|topical anesthesia (Ultradent Products, Inc)
16028964|NCT02674191|Procedure|Administration of , Mepivacaine-l|local anesthesia
16028965|NCT02674191|Procedure|BETADINE povidone-iodine 10%|a local disinfectant
16028966|NCT02674191|Drug|(150g Clindamycin/tds) for 1 week|Postoperative antibiotic
16028967|NCT02674191|Drug|(Cataflam 25mg), are prescribed post-operatively|an analgesic
16028968|NCT02674178|Procedure|Invitro fertilization|"All participants underwent long protocol. Daily SC injection of Triptorelin 0.1 mg started at day 21 of the cycle prior to stimulation cycle and continued till the day of hCG injection. Gn stimulation started in a starting dose of 150-300 IU/day depending on patients age and previous gonadotropin response. then the dose was adjusted according to ovarian response monitored by serum E2 and ultrasound evaluation. All patients were followed up by Transvaginal ultrasound scan daily or on alternate days
~Triggering by HCG 10000 IU IM when at least 2 follicles reached a mean diameter of 18 mm [18]
~Ovum pick-up (OPU) was done 34-36 hours after hCG injection Transfer of cleaving embryos was done on day 3 after oocyte retrieval"
16028969|NCT02674165|Behavioral|HART|Skills based sexual education intervention plus PTSD awareness
16028970|NCT02674152|Drug|BI 836880|
16028971|NCT02674139|Device|Copper T 380A IUD|intrauterine contraceptive device T-shaped loaded with cupper
16028972|NCT02674126|Behavioral|Control group|Patients in the control group listened to a blank CD connected to the patient ears before induction of anesthesia and continued during intra operative period till extubation in intensive care unit
16028973|NCT02674126|Behavioral|Maternal sound group|The recorded maternal voice (while they are singing the most popular songs their children like or telling a story to help their children to sleep) listened by CD player connected to the patient ears before induction of anesthesia and continued during intra operative period till extubation in intensive care unit
16028974|NCT02674113|Drug|regional anesthesia bupivacaine|a single shot fascia iliaca block using bupivacaine prior to hip arthroscopy
16028975|NCT02674113|Drug|regional anesthesia placebo|subcutaneous injection procedure using a normal saline placebo (0.9% sodium chloride in water)
16028976|NCT02674100|Other|Registry|
16028977|NCT02674074|Device|infrared thermography|measurement of corneal temperature by infrared thermography before and after cold provocation
16028978|NCT02674061|Biological|Pembrolizumab|Administered at a dose of 200 mg via IV infusion on Day 1 of each 21-day cycle
16028979|NCT02674048|Other|Metvix|
16028980|NCT02674035|Procedure|Correction of diastasis of the rectus abdominis muscles|Thirty women with similar abdominal deformities, who had had at least one pregnancy, were randomized into three groups to undergo abdominoplasty. Plication of the anterior rectus sheath was performed in two layers with 2-0 monofilament nylon suture (control group) or in a single layer with either a continuous 2-0 monofilament nylon suture (group I) or using a continuous barbed suture (group II). Operative time was recorded. All patients underwent ultrasound examination preoperatively and at 3 weeks and 6 months postoperatively to monitor for diastasis recurrence. The force required to bring the anterior rectus sheath to the midline was measured at the supraumbilical and infraumbilical levels.
16028981|NCT02674022|Dietary Supplement|Prenatal supplement|Treatment with a standard and optimized prenatal supplement, dependent on laboratory evaluations of participants.
16028982|NCT02674009|Drug|Vismodegib|Participants with laBCC will receive a dosing of Vismodegib in accordance with local clinical practice and local labeling.
16028983|NCT02673996|Drug|Phenylephrine|incremental small doses of IV phenylephrine to find the dose that transiently raises systolic blood pressure by 25 mmHg
16028984|NCT02673996|Drug|Isoproterenol|incremental small doses of IV isoproterenol to find the dose that transiently raises heart rate by 25 bpm
16028985|NCT02673983|Procedure|Endoscopic full-thickness biopsy|
16028986|NCT02673957|Other|Blood pressure cuff protocol|4 cycles of pneumatic blood pressure cuff inflation to 200mmHg for 5 minutes followed by 5 minutes of deflation. Each subsequent cycles commences as soon as the previous cycle is completed.
16028987|NCT02673944|Device|Peritron+|Peritron+ will be connected to a standard urodynamic analyzer system to measure vesical pressure
16028988|NCT02673931|Drug|Byetta (Lilly, Exenatide)|See description of arms
16028989|NCT02673931|Drug|Conoxia (AGA, oxygen)|See description arms
16028990|NCT02673931|Drug|20% Human Albumin|
16028991|NCT02673918|Other|Home-based upper-body rehabilitation with online support|"Participants will be given written educational material, in which the physiotherapist marks the exercises specifically recommended for the individual patient. In addition, participants will get a personal password giving access to the BRECOR website for 12 weeks. The website contains professionally filmed videos of upper-body rehabilitation exercises (joint mobility and muscle strength) and instructions in scar tissue massage and manual lymph drainage. Furthermore, mindfulness sessions and additional information about prevention and early detection of late effects after breast cancer treatment are available on the website.
~On average, participants will complete three rehabilitation exercises 5-7 times weekly with an anticipated duration of approximately 20 minutes."
16028992|NCT02673905|Other|Tissue Engineered Product|Implantation of tissue engineered products
16029031|NCT02673580|Other|Standard telePRO|Standard care: fixed interval telePRO follow-up. Patients receive a questionnaire with individually pre-specified intervals.
16029032|NCT02673567|Drug|TEV-48125 - 1|Subcutaneous administration Dose Regimen 1
16029033|NCT02673567|Drug|TEV-48125 - 2|Subcutaneous administration Dose Regimen 2
16029034|NCT02673567|Drug|TEV-48125 - 3|Subcutaneous administration Dose Regimen 3
16029035|NCT02673567|Drug|Placebo|Matching Placebo
16029214|NCT02672072|Other|questionnaire to define the presence of job strain at 6 months|
16028993|NCT02673892|Other|Patient Oriented Discharge Summary|The PODS provides a written template for providers to engage patients and caregivers when reviewing important discharge instructions on medications, activity and diet restrictions, follow-up appointments and worrisome symptoms warranting emergency care. The PODS also uses plain and simple wording, large fonts, pictograms, and includes white space for patients to take notes and provides the option for translation of major headings into the most common spoken languages. As this will be a pragmatic design, we may make modifications to the process involved in completing the PODS, such as using pre-filled disease-specific information, if system processes and providers involved deem it more usable and feasible.
16028994|NCT02673879|Other|Pericardiocentesis with Alteplase|Complete percutaneous pericardial drainage facilitated by intrapericardial alteplase
16028995|NCT02673879|Other|Conventional Pericardiocentesis|Conventional pericardiocentesis when indicated
16028996|NCT02673866|Drug|DS-1971a|
16028997|NCT02673866|Drug|placebo|
16028998|NCT02673866|Drug|pregabalin|pregabalin
16028999|NCT02673840|Drug|Ketotifen|2 mg of Ketotifen, twice a day for a total of ten (10) doses
16029000|NCT02673840|Drug|Placebo|Identical tablets containing 0 mg of Ketotifen, twice a day for a total of ten (10) doses
16029001|NCT02673827|Other|Progressive muscle relaxation|Intervention group: 20 patients with relapsing-remitting multiple sclerosis receive five sessions of Progressive Muscle Relaxation under the supervision of a researcher in neurology clinic. Before and after each session of the Progressive Muscle Relaxation They will be measured heart rate, respiratory rate and blood pressure. Participants will be guided to realize the Progressive Muscle Relaxation daily for 8 weeks, the time of day you feel more comfortable. the same receive education and training as the technical as well as a audio and a leaflet with the description the stages of the Progressive Muscle Relaxation. Control group: 20 patients with relapsing-remitting multiple sclerosis only receive traditional treatment.
16029002|NCT02673814|Biological|durvalumab|
16029003|NCT02673814|Biological|bavituximab|
16029004|NCT02673801|Other|Orthopedic assessment in the outpatient clinic|Orthopedic assessment based on clinic evaluation, patient symptoms and radiographic evaluation
16029005|NCT02673788|Other|observation without intervention in this follow up study|observation without intervention in this follow up study
16029006|NCT02673775|Other|Clean Air|Subjects will have the clean air exposure first, followed by the ozone exposure
16029007|NCT02673775|Other|Ozone|Subjects will have the ozone exposure first, followed by the clean air exposure
16029008|NCT02673749|Drug|RP-G28|Study drug taken orally
16029009|NCT02673749|Other|Placebo|Placebo taken orally
16029010|NCT02673736|Drug|PLX73086|
16029011|NCT02673723|Drug|Docozine|dezocine（Dez A：0.05 mg/kg，Dez B：0.1 mg/kg and Dez C：0.15 mg/kg, diluted to 5 ml respectively) is given for 10 seconds after surface anesthesia
16029012|NCT02673723|Drug|Saline|The same amount of saline is given for 10 seconds after surface anesthesia
16029013|NCT02673710|Other|No intervention|Besides participant reported outcomes and a muscle strength test no interventions are administered, all treatment decisions are at the discretion of the physician and will be in line with local clinical practice and labeling
16029014|NCT02673697|Device|Perceval valve|Sutureless Aortic Biological Valve
16029015|NCT02673697|Device|other stented biological valve|Any biological stented valves available on the market (Edwards, Medtronic, St.Jude, LivaNova, Labcor)
16029016|NCT02673684|Device|Experimental NSS|5-Day Active electro auricular device that delivers electrical impulses that stimulate the neurovascular bundles in the ear.
16029017|NCT02673684|Device|Sham NSS|(5 minute active) Electro Auricular Device that delivers electrical impulses to neurovascular bundles in the ear.
16029018|NCT02673671|Device|G-Tech Myoelectric recording device|A minimum of three patches are placed on the abdomen of the patient to record myoelectric activity.
16029019|NCT02673658|Behavioral|Motor + problem solving|Developmental motor tasks incorporating cognitive concepts such as object permanence
16029020|NCT02673658|Behavioral|body weight support training|Mobility tasks to change positions or move the body with assistance to initiate movement
16029021|NCT02673645|Other|SAGA Innovations|An intensive math tutoring program.
16029022|NCT02673632|Drug|Merional ®|Using the long protocol of controlled ovarian hyperstimulation (COH). Down regulation by (Decapeptyl ®, Ferring) 0.1mg subcutaneously once daily starting from day 18 of the preceding cycle, human menopausal gonadotrophin (hMG) (Merional ®, IBSA) 75 IU starting from cycle day two after confirmation of down regulation (thin endometrium, number of follicular activity, E2 < 50 pg/mL). hMG dose is optimized according to age, BMI, antral follicles count (AFC), the local protocol, FSH level and previous response. Usually PCO patients start by 150 IU.
16029023|NCT02673619|Drug|Umeclidinium|Umeclidinium (GSK573719) 1.85% will be supplied as a clear, colourless solution, free from visible particulates, for topical application. Each subject total daily dose will be calculated as per study reference manual (SRM) using subject's hand area. A single dose of study treatment will be based on the size of the subject's hand in order to provide coverage of approximately 2µL/ cm^2. If certain pre-specified criteria for safety and tolerability are met, consideration will be given to decreasing the dose by decreasing the concentration of the topical formulation to 1.15% for the remaining subjects.
16029024|NCT02673619|Drug|Vehicle|The vehicle will be supplied as a clear, colorless solution, free from visible particulates, for topical application.This formulation will be similar to the umeclidinium formulation except that it will be devoid of the umeclidinium parent. A single dose of study treatment will be based on the size of the subject's hand in order to provide coverage of approximately 2µL/ cm^2
16029025|NCT02673606|Drug|Estradiol 2Mg Tablet|one 2 mg dose of estradiol (obtained from Estrace® Tablets, 2.0 mg estradiol tablets, USP, Warner Chilcott),
16029026|NCT02673606|Drug|Estradiol 4Mg Tablet|two 2 mg pills estradiol(obtained from Estrace® Tablets, 2.0 mg estradiol tablets, USP, Warner Chilcott),
16029027|NCT02673606|Drug|Placebo Pills|inactive placebo pills
16029028|NCT02673593|Drug|DS102|
16029029|NCT02673593|Drug|Placebo|
16029030|NCT02673580|Other|Open Access telePRO|"In open access, contacts to the outpatient clinic are initiated solely by the patient. Contacts may be in the form of a PRO assessment like in standard telePRO, but at a time decided by the patient via the Danish National Health website Sundhed.dk."
16029215|NCT02672072|Other|questionnaire to define the presence of job strain at 12 months|
16029036|NCT02673554|Drug|GIP Bolus|bolus injections of synthetic human GIP (50 pmol/kg body weight) administered 30 and 120 min after commencing the hyperglycemic clamp
16029037|NCT02673554|Drug|GIP Clamp|hyperglycemic clamp with the continuous intravenous infusion of 2 pmol.kg-1.min-1 synthetic human GIP between 30 and 180 min
16029038|NCT02673554|Procedure|Oral glucose tolerance test (OGTT)|an oral glucose challenge (75 g)
16029039|NCT02673554|Procedure|hyperglycemic clamp|a hyperglycemic clamp (capillary venous glucose concentration ~ 8.5 mmol/l)
16029040|NCT02673541|Device|AXIOS™ stent|Arm 1 will undergo EUS-guided cystogastrostomy/enterostomy and placement of the AXIOS™ stent 10-15mm (saddled diameter; choice at the discretion of the treating gastroenterologist) though the tract into the collection cavity, and correct positioning of the inner flange confirmed by EUS prior to deploying within the stomach or duodenum.
16029041|NCT02673541|Device|Double Pigtail Stents|Arm 2 will undergo EUS-guided cystogastrostomy/enterostomy and placement of multiple double pigtail stents (i.e. ≥2) through the tract into the collection cavity.
16029042|NCT02673528|Procedure|Laparoscopic appendectomy|Two types of laparoscopic surgery were performed. Total laparoscopic appendectomy or laparoscopic assisted appendectomy
16029043|NCT02673515|Behavioral|Alternate day fasting|Subjects are requested to fast every other day. Calorie free fluids are allowed.
16029044|NCT02673502|Dietary Supplement|simple carbohydrate drink|Patients will ingest 400 ml of the simple carbohydrate drink consisting of commercial orange juice without pulp which contains 50 grams fructose/galactose 2 hours before surgery.
16029045|NCT02673502|Dietary Supplement|complex carbohydrate drink|Patients will ingest 400 ml of the complex carbohydrate drink containing 50 grams of maltodextrin powder in water ( orange food color and artificial orange flavor have been added to the drink) 2 hours before surgery
16029046|NCT02673489|Drug|DCV|
16029047|NCT02673489|Drug|SOF|
16029048|NCT02673489|Drug|RBV|
16029049|NCT02673476|Drug|ALS-008176|ALS-008176 tablets
16029050|NCT02673476|Drug|Placebo|Identical placebo tablets
16029051|NCT02673463|Drug|Spironolactone|25 mg once daily
16029052|NCT02673463|Drug|Placebo|Visually identical to spironolactone, once daily
16029053|NCT02673437|Other|This is a non-interventional study|This is a non-interventional study
16029054|NCT02673424|Procedure|FFR-guided stenting|"The percutaneous coronaryintervention using drug-eluting stent will be indicated according to following criteria in the FFR-guided strategy arm
~* Criteria for revascularization: The FFR ≤ 0.80 will be targeted for PCI"
16029055|NCT02673424|Procedure|IVUS-guided stenting|"The percutaneous coronaryintervention using drug-eluting stent will be indicated according to following criteria in the IVUS-guided strategy arm
~* Criteria for revascularization: Minimum lumen area (MLA) ≤ 3mm2 or (MLA ≤ 4mm2 AND Plaque burden >70%)"
16029056|NCT02673411|Device|ultrasound shear wave elastography|ultrasound shear wave elastography is performed in GE ultrasound scanner according to guidelines of ultrasound elastography.
16029057|NCT02673398|Other|Comprehensive Geriatric Assessment|Ancillary studies
16029058|NCT02673398|Other|Laboratory Biomarker Analysis|Correlative studies
16029059|NCT02673398|Drug|Neratinib|Given PO
16029060|NCT02673398|Other|Pharmacological Study|Correlative studies
16029061|NCT02673385|Other|Brazelton scale|
16029062|NCT02673372|Drug|Morphine|intravenous Morphine given at 0.1 mg/kg as intravenous infusion (10 min) with a maximum dose of 10 mg. The device is the Care Fusion Alaris PC.
16029063|NCT02673372|Drug|Ketamine|Ketamine administered in sub-dissociative doses 0.3 mg/kg as a intravenous infusion (10 min). The device is the Care Fusion Alaris PC.
16029064|NCT02673359|Drug|Progesterone|Vaginal progesterone suppositories (Cyclogest®, Actavis, Barnstaple, EX32 8NS, United Kingdom) will be given in a dose of 400 mg/day
16029065|NCT02673359|Procedure|Cervical cerclage|Cervical cerclage will be performed by transvaginal placement of purse-string stitch suture at the cervicovaginal junction, without mobilization of the urinary bladder (McDonald cervical cerclage)
16029066|NCT02673333|Drug|Pembrolizumab|
16029069|NCT02673307|Behavioral|1 chewing gum over 45 minutes|
16029070|NCT02673294|Other|balance virtual rehabilitation|
16029071|NCT02673281|Other|Walnut shake|walnut shake will be administered for 5 days as a morning snack instead of a typical breakfast
16029072|NCT02673281|Other|Placebo shake|placebo shake will be administered for 5 days as a morning snack instead of a typical breakfast
16029073|NCT02673268|Procedure|Mastectomy|
16029074|NCT02673268|Device|Da Vinci Robot Xi|
16029075|NCT02673255|Biological|Tetanus and Diphtheria (Td) Vaccine|
16029076|NCT02673242|Device|Threshold IMT Philips Respironics|Inspiratory muscle training
16029077|NCT02673229|Drug|Collagenase Santyl|A sterile, enzymatic debriding agent which contains 250 collagenase units per gram of white petrolatum, United States Pharmacopeia (USP).
16029216|NCT02672059|Other|Observation|No intervention
16135136|NCT01896349|Drug|Clomipramine|
16029078|NCT02673229|Drug|Bacitracin|One gram is equal to 500 bacitracin units; one unit of bacitracin is equivalent to 0.026 milligrams.
16029079|NCT02673216|Other|No intervention|
16029080|NCT02673203|Device|Continuous Glucose Monitoring System (CGMS)|The CGMS consists of 3 parts: sensor, transmitter and monitor. The small sensor measures the glucose levels from the interstitial tissue. The transmitter is attached on top of the sensor and connects wirelessly to the monitor. The sensor is sterile and comes in an unopened package. It has a plastic wire-like tip that is placed under the skin and continuously measures the glucose levels. One of the study physicians will insert the CGMS wire-like tip under the volunteer's skin with the use of the DEXCOM sensor insertion kit. The transmitter is snapped to the sensor pod and the sensor/transmitter unit will be attached to the skin with an adhesive patch. The monitor is the size of a small hand-held device with a digital screen that displays a graph showing the glucose levels from the previous 4-24 hours.
16029081|NCT02673203|Behavioral|Food log|The Food Record will ask about amount and type of food consumed throughout the day. The participants will also register how hungry they are before the meal and how full they feel after they ate, and type and duration of physical activity
16029082|NCT02673177|Procedure|robot-assisted total mesorectal excision|The Da Vinci Surgical System may help to protect subtle anatomical structure and provide more functional protection when compared to laparoscopic surgery. This study aimed to compare RTME and laparoscopic total mesorectal excision (LTME) for rectal cancer with regard to Urinary, sexual function and sphincter- preservation outcomes.
16029083|NCT02673177|Procedure|laparoscopic total mesorectal excision|Traditional laparoscopic total mesorectal excision (LTME) for rectal cancer.
16029084|NCT02673164|Biological|CSCC_ASC|The stem cells will be injected directly into the myocardium using the NOGA XP system (BDS, US)
16029085|NCT02673151|Procedure|Computed Tomography|Undergo 68Ga-PSMA PET/CT
16029086|NCT02673151|Drug|Gallium Ga 68-labeled PSMA-11|Given IV
16029087|NCT02673151|Other|Laboratory Biomarker Analysis|Correlative studies
16029088|NCT02673151|Procedure|Positron Emission Tomography|Undergo 68Ga-PSMA PET/CT
16029089|NCT02673138|Drug|canagliflozin|basal interruption with canagliflozin
16029090|NCT02673138|Other|basal interruption without canagliflozin|basal interruption
16029091|NCT02673125|Genetic|MitoGrade|MitoGrade refers to the mitochondrial DNA assessment in embryos.
16029092|NCT02673112|Behavioral|Subthreshold exercise (STEP) with mobile health coaching|Aerobic exercise program performed below the HR threshold that causes symptoms and administered by an RA using mobile health coaching
16029093|NCT02673112|Behavioral|Light stretching (LS)|Brief daily stretching routine.
16029094|NCT02673099|Procedure|HDF online|Hemodialysis by the HDF online method
16029095|NCT02673086|Other|coracoid approach|Coracoid approach for ultrasound guided infraclavicular brachial plexus block
16029096|NCT02673086|Other|retroclavicular approach|retroclavicular approach for ultrasound guided infraclavicular brachial plexus block
16029097|NCT02673073|Other|Patient's diary|"Patients in the intervention arm will be educated to measure body weight, blood pressure, and heart rate every morning after using toilet. Number of remaining pills of the previous day is for the assessment of drug compliance. Degree of pitting edema is graded from 0 (no edema), 1 (mild), 2 (moderate), 3 (severe) and, degree of dyspnea is graded from 0, 1, 2, 3, corresponding to NYHA class I, II, III, and IV, respectively.
~Patients are instructed to visit or call the HF-outpatient clinic, when they have (i) body weight gain more than 1 kg/day or 2kg in 7 days;(ii) aggravation of pitting edema by one degree; (iii) aggravation of dyspnea by one grade."
16029098|NCT02673073|Other|Patient's education|All patients will receive patient's information/education booklet on the heart failure including life style modification.
16029099|NCT02673060|Drug|MBC-11|0.5 mg/kg-10 mg/kg , IV (in the vein) on day 1-5 of each 28 day cycle. Number of cycles: 2, in case of partial metabolic reaction or stable metabolic reaction - up to 4.
16029100|NCT02673047|Biological|botulinum toxin Type A|Botulinum toxin Type A (Botox®) injection as prescribed as standard of care in clinical practice.
16029101|NCT02673021|Procedure|Microwave ablation|Microwave tumor ablation is a procedure that uses heat made by an electric current to destroy a tumor (ablation). With imaging equipment, such as ultrasound or CT (computed tomography), and a small incision made in the skin, the tumor is located and treated with radiofrequency energy. The cells that are killed by the microwave ablation are typically not removed but are eventually replaced by fibrosis and scar tissue.
16029102|NCT02673008|Biological|donor lymphocyte infusion|DLI was administered at a median dose of 1.0 (range 0.7-1.4) ×10*8 mononuclear cells/kg.
16029103|NCT02672995|Radiation|Fractionated stereotactic radiosurgery|"Fractionated stereotactic radiosurgery:
~Group 1: tumors 1.5~2.5 cm in diameter Dose level 1: 21 Gy in 3 fractions Dose level 2: 24 Gy in 3 fractions Dose level 3: 27 Gy in 3 fractions Group 2: tumors 2.5~3.5 cm in diameter Dose level 1: 18 Gy in 3 fractions Dose level 2: 21 Gy in 3 fractions Dose level 3: 24 Gy in 3 fractions Three fractions will be given in one week with at least 1 day break."
16029104|NCT02672995|Drug|bevacizumab|"Concurrent bevacizumab:
~Bevacizumab 7.5 mg/kg will be given one day before the first fraction of radiosurgery and 2 weeks after the first dose of bevacizumab."
16029105|NCT02672982|Other|NUTPSY treatment|The psychosocial component of the new combined treatment involves seven weekly counselling sessions with mothers focused on feeding, emotional attachment, stages of child development, stimulation, emotional responsiveness and interaction, and on concerns/strategies of child care and parenting.
16029106|NCT02672982|Other|NUT treatment|Only the standard nutritional treatment in the form of Ready-to-use Therapeutic Food (RUTF) is administered.
16029107|NCT02672969|Device|RapidVac Smoke Evacuator|"The intervention group, using the smoke evacuation (RapidVac Smoke Evacuator) in each OR, the data collection for the amount of surgical smoke and bio-aerosols' particles will be collected during pre-surgery and during surgery (every 30 mins).
~Before using the smoke evacuation, the amount of surgical smoke and bio-aerosols' particles in the surgical field and OR environment will be measured by AeroTraxTM Handheld Airborne Particle Counter. This record includes the amount and size of smoke and bio-aerosol particles in each area such as anesthetic area (anesthesiologist physicians and nurses area); instrument preparation area (circulating nurses area) and surgical area (surgeons and scrub nurses areas)."
16029108|NCT02672956|Procedure|Ten mm trocar|
16029217|NCT02672046|Other|Assessment at the Clinic of Sports Injuries|Assessment at the Clinic of Sports Injuries as well as a new algorithm (using patient-reported symptoms will be applied
16029109|NCT02672943|Behavioral|Rehabilitation treatment|The walking exercise will be aerobic with a Borg rating perceived exertion around 11-14 scales. Before and after the 12 weeks rehabilitation training, should accept MRI and Clinical assessments.
16029110|NCT02672943|Other|non-rehabilitation treatment|The walking exercise will be aerobic with a Borg rating perceived exertion around 11-14 scales. Before and after the 12 weeks non-rehabilitation training, should accept MRI and Clinical assessments.
16029111|NCT02672930|Device|Electrocardiogram (ECG)|ECG and vital parameters were obtained before and after recommended standard calcium gluconate therapy for hyperkalemia
16029112|NCT02672917|Drug|MVT-5873|intravenous infusion (IV)
16029113|NCT02672917|Drug|modified FOLFIRINOX (mFOLFIRINOX)|IV
16029114|NCT02672904|Device|CO2 laser|surgical removal of carcinoma from the vocal cords with CO2 laser
16029115|NCT02672904|Device|KTP laser|surgical removal of carcinoma from the vocal cords with KTP laser
16029116|NCT02672891|Device|condom balloon catheter|"The condom balloon catheters were inserted into the uterine cavity digitally or with forceps .Tight vaginal pack was inserted or cervical stitch was done to prevent displacement of the balloon catheter.
~(2)-Insertion at Cesarean Section: The catheter was inserted through the uterine incision (pushing the tip to the fundus and the drainage port through the cervix into the vagina) or transvaginally and inﬂated after the uterine incision was closed."
16029117|NCT02672878|Device|Bioresorbable vascular scaffold|
16029118|NCT02672865|Drug|Hyperthermic Intraperitoneal Chemotherapy (HIPEC)|Hyperthermic intraperitoneal chemotherapy (HIPEC) is a procedure in which the internal parts of the abdomen are bathed in a warm solution of anti-cancer medications for 90 minutes.
16029119|NCT02672852|Drug|Risankizumab|Risankizumab administered by subcutaneous injection
16029120|NCT02672852|Drug|Placebo|Placebo for risankizumab administered by subcutaneous injection
16029121|NCT02672839|Drug|LGD-6972 Solution|15 mg of LGD-6972
16029122|NCT02672839|Drug|LGD-6972 Capsules|15 mg LGD-6972
16029123|NCT02672826|Procedure|Adipose tissue surgery|Adipose tissue (gluteo-femoral and abdominal) will be obtained from women programmed for surgery in which the estrogenic status as well as adipose tissue mass profile will be evaluated
16029124|NCT02672813|Procedure|Pectoral nerve I and II block|Under Ultrasound guidance, Pectoral nerve I and II block is given for every breast surgery by using 10 and 20 ml of 0.25% Ropivacaine respectively
16029125|NCT02672800|Behavioral|the Reclaiming Yourself tool|This tool is a behavioural writing intervention, intended to facilitate bereavement for spousal caregivers of persons with dementia
16029126|NCT02672787|Behavioral|ED-based behavioral intervention|Data collection, antihypertensive adherence assay, antihypertensive interview and EHR review, barrier identification, personalized goal setting, communication with PCP, and reminder messages/engagement messages.
16029127|NCT02672787|Behavioral|ED usual care plus education|Data collection, antihypertensive adherence assay, antihypertensive interview, EHR review, and usual care education.
16029128|NCT02672774|Procedure|Magnification endoscopy with narrow band imaging|Magnification endoscopy with narrow band imaging is an optically enhanced endoscopic imaging technique used for better characterization of lesions as compared to white light endoscopy alone. With only a push of a button optical filters are applied to reduce the illuminating light to 415 nm (blue) and 540 nm (green) wavelengths, which are selectively absorbed by haemoglobin. As a result the superficial vascular networks are highlighted and morphological changes in capillary patterns can be described for different gastrointestinal lesions.
16029129|NCT02672774|Device|Probe based confocal laser endomicroscopy|Confocal laser endomicroscopy enables in vivo microscopic analysis during ongoing endoscopy and has shown good accuracy for predicting the histopathological diagnosis in lesions of both the upper and lower GI tract. During the examination fluorescein is administered intravenously as a contrast agent, highlighting the vessels and surrounding epithelial structures. The probe based confocal laser endomicroscopy system can be easily integrated into the imaging protocol as it uses flexible catheter probes that can be passed through the working channels of the endoscopes once the area of interest has been identified.
16029130|NCT02672761|Behavioral|MBSR meditation|"Adopted from buddhism for western societies by Jon Kabat-Zinn, MBSR has been described as a group program that focuses upon the progressive acquisition of mindful awareness, of mindfulness. The MBSR program is an eight-week workshop taught by certified trainers that entails weekly group meetings, homework, and instruction in three formal techniques: sitting mindfulness meditation, body scanning and simple yoga postures. Sitting meditation includes concentration on the breathing while not adhering to the flow of thoughts or emotions as well as the development of empathy and loving kindness for all persons. Body scanning is the first prolonged formal mindfulness technique taught during the first four weeks of the workshop, and entails quietly lying on one's back and focusing one's attention on various regions of the body, starting with the toes and moving up slowly to the top of the head."
16029131|NCT02672761|Behavioral|MBT training|"A specific memory brain training stimulates by a validated program according to Kawashima from the Industry University Research Project the according areas in the prefrontal lobe for calculation, logical reflection, optic/episodes and memory. The computerized program adopts to the difficulty level of the trainee. Selected were trainings for the categories working/semantic and episodic/optical memory and logic/calculation adjusted to the individual's selection from all categories but various themes (like sports, cars etc.)."
16029132|NCT02672761|Behavioral|Wellness|"The Brain Light Wellness chair is assessed for the stress reduction in industry and public Enterprises. In a European study 97% of subjects reported a stress reduction, improved well-being, performance and increased vitality, less fatigue and petulance. The chair 3D-Float-plus system comprises of a massage chair in sitting to lying position, a headset with earphones a lighted glasses for visual and audio Stimulation. One standardized session of 45 min duration was chosen for the study that combined a short massage period with a relaxation trance session."
16029133|NCT02672761|Behavioral|Control|The waiting period for the MBSR training to start simply should include no changes in lifestyle, recreational activity or intellectual training
16029134|NCT02672748|Other|Garden|Two years of financial and technical home gardening support for new gardeners
16029175|NCT02672371|Device|Active eMNS|Each session will consist of right eMNS stimulation that will last 20-minutes. The frequency of stimulation will be random assigned using random frequency interval. The electrodes that will be used will be standard transcutaneous electrodes. The electrodes will be placed on the wrist.
16135137|NCT01896349|Drug|nortriptyline|
16029135|NCT02672735|Other|Corrective Exercise Programming|Participants will be given a four-week corrective exercise protocol, with four corrective exercise sessions prescribed each week. Participants in the CEP Group will be required to complete a minimum of three of these four training sessions per week throughout the four-week corrective exercise program intervention. All corrective exercise programming will be created through the Fusionetics Human Performance System. This system, along with weekly compliance questionnaires, will also assess the compliance-level among the participants.
16029136|NCT02672722|Drug|Definity|During kidney ultrasound, Definity microbubbles will be injected into the vein to see how blood flows through the kidneys
16029137|NCT02672722|Other|Exercise|
16029138|NCT02672722|Other|Kidney Ultrasound|This done before and after exercise with the help of Definity to see changes in kidney blood flow
16029139|NCT02672709|Drug|apixaban|
16029140|NCT02672696|Device|FluoroMap 3D|Use of the 3D reconstruction software developed by the manufacturer of the Gamma Nail (e.g. Stryker Inc.) along with the standard fluoroscopy
16029141|NCT02672670|Behavioral|Experimental: Intervention group---coping-oriented supportive programme|
16029142|NCT02672670|Behavioral|Active Comparator: Comparison group---a didactic talk (usual care)|
16029143|NCT02672644|Device|Emervel Classic|Subjects requiring bilateral correction of NLFs and meeting eligibility criteria will be enrolled and treated with Emervel Classic (moderate NLFs; WSRS = 3/3)
16029144|NCT02672644|Device|Emervel Deep|Subjects requiring bilateral correction of NLFs and meeting eligibility criteria will be enrolled and treated with Emervel Deep (severe NLFs; WSRS = 4/4).
16029145|NCT02672631|Other|physical examination|Investigators will apply for evaluate clinical median nerve function to all of groups. (Adductor pollicis power (x/5), sense exam(normal/hipoestesia/anestesia) of hand, tinnel test(+/-), DASH score, DN4 neuropathic pain score)
16029146|NCT02672631|Other|DTI|Investigators will apply for evaluate median nerve healing countable results to all of groups (apparent diffusion coefficient for avarage diffusion (ADC) and fractional anisotropy diffusion orientation(FA) - FA :0 means diffusion is homogenic FA:1 means tissue has heterogenic diffusion
16029147|NCT02672631|Other|ENMG|Investigators will apply for evaluate median nerve healing countable results to all of groups. And they will evaluate motor nerve transmission speed, sensitive nerve transmission speed and united muscle action potential
16029148|NCT02672605|Other|Pennsylvania State Abortion Consent|Measuring the level of stigma felt pre- or post-exposure to the abortion consent language.
16029149|NCT02672592|Drug|Anakinra|Anakinra 100mg s.c. bid
16029150|NCT02672592|Drug|Sodium Chloride 0.9%|Sodium Chloride 0.9% s.c. bid
16029151|NCT02672566|Drug|Enoxaparin|Enoxaparin will be delivered to the patients every day at the dose of 4 000 Ui.
16029152|NCT02672566|Other|Usual care|Patients will all benefit from the usual care
16029153|NCT02672553|Device|EDWARDS INTUITY Valve System, Model 8300A|To evaluate cardiac performance characteristics and adverse events rates associated with the EDWARDS INTUITY Valve in patients undergoing MIS-AVR.
16029154|NCT02672553|Device|Stented Aortic Bioprostheses|In comparison to control valves available on the market undergoing FS-AVR
16029155|NCT02672540|Drug|SANGUINATE 320 mg/kg|Two-hour infusion of SANGUINATE on Day 1 and Day 2
16029156|NCT02672540|Drug|Normal Saline|Two-hour infusion of Normal Saline and Day 1 and Day 2
16029157|NCT02672527|Drug|Trabectedin|
16029158|NCT02672527|Drug|Dexamethasone|
16029159|NCT02672514|Device|Minimally invasive extracorporeal circulation (MiECC)|Minimally invasive extracorporeal circulation (MiECC) is an extracorporeal circulation systems used for cardiopulmonary bypass.
16029160|NCT02672514|Device|Conventional extracorporeal circulation (CECC)|Conventional extracorporeal circulation (CECC) is an extracorporeal circulation system used for cardiopulmonary bypass.
16029161|NCT02672501|Drug|anti-CD19-CAR-T cells|a 2nd CAR, CD19 as target protein, 4-1BB as co- stimulator, and optimized the spatial conformation by a suitable hinge & transmembrane domain sequences
16029162|NCT02672488|Drug|Sorafenib|Standard treatment for advanced HCC
16029163|NCT02672488|Drug|Metformin|To evaluate the safety and efficacy of the combined treatment of Metformin and Sorafenib for advanced HCC
16029164|NCT02672475|Drug|Galunisertib|Given PO
16029165|NCT02672475|Other|Laboratory Biomarker Analysis|Correlative studies
16029166|NCT02672475|Drug|Paclitaxel|Given IV
16029167|NCT02672462|Device|Radio frequency renal denervation system (Golden Leaf GL-06E15A)|
16029168|NCT02672449|Radiation|Carbon Ions Boost Followed by Pelvic Photon Radiotherapy|The patients will be enrolled either at the Centro Nazionale di Adroterapia Oncologica (CNAO), Pavia, Italy, at the Division of Radiation Oncology of the European Institute of Oncology (IEO), Milan, Italy, or at the Fondazione IRCCS Istituto Nazionale Tumori (INT), Milan, Italy. The treatment will include a boost phase on the whole prostate with carbon ions performed at CNAO followed by a pelvic photon RT, with IMRT performed with conventional fractionation of 1.8 Gy per fraction up to 45 Gy to the pelvic lymph nodes, prostate and seminal vesicles. The total dose prescribed to the prostate boost with carbon ions will be of 16.6 GyE in 4 fractions (4.15 GyE/fraction).
16029169|NCT02672436|Drug|ENERGI-F703|Standard of care and ENERGI-F703 are applied for treatment of diabetic foot ulcers.
16029170|NCT02672436|Drug|ENERGI-F703 matched vehicle|Standard of care and ENERGI-F703 matched vehicle are applied for treatment of diabetic foot ulcers.
16029171|NCT02672423|Drug|Abemaciclib Capsules (Reference Formulation)|Administered orally
16029172|NCT02672423|Drug|Abemaciclib Tablet (Test Formulation)|Administered orally
16029173|NCT02672397|Behavioral|Additional Epidural Education|All women allocated to receive additional epidural educational will be given a language appropriate pamphlet and video on neuraxial anesthesia. The video and pamphlet will be in the subject's primary language. After the subject watches the educational video they will be given an opportunity to go through the pamphlet with the research assistant and ask any questions they may have. For Spanish-speaking subjects this will occur through a telephone interpreter. The obstetric anesthesia providers and obstetricians caring for the subject will be absent for the educational video and post-video conversation.
16029174|NCT02672384|Procedure|Dental examination and a point of care P. gingivalis test (Denka Seiken Co (Japan) )|Dental examination Study exams (oral and blood sample collection)
16029213|NCT02672072|Other|Simulation during the study (5-day specific training with dedicated scenario done by an ICU expert simulation team)|
16029176|NCT02672371|Device|Sham eMNS|Each session of sham eMNS will be the same as active, except the device will be turned off. Similar parameters will be used (for 20 minutes and same electrode placement), except no stimulation will be delivered.
16029177|NCT02672358|Drug|Dabrafenib|Oral Dabrafenib 150 mg BID
16029178|NCT02672358|Drug|Trametinib|Oral Trametinib 2 mg QD
16029179|NCT02672345|Drug|Sevoflurane|The Sevoflurane Group will receive between 0.7 and 1.5% of sevoflurane CAM only during CPB period. While Not Sevoflurane Group will receive only intravenous anesthetic agents.
16029180|NCT02672332|Drug|SB204 4%|Once daily
16029181|NCT02672332|Drug|Vehicle Gel|Placebo comparator
16029182|NCT02672319|Procedure|EUS-guided glue injection|Experimental: EUS-guided glue injection Gastroesophageal varices > 3mm in diameter will be treated with EUS guided cyanoacrylate injection for variceal obturation in standard fashion. A conventional 19G needle (19G-Echotip needle, Cook Medical, USA) will be advanced into the target varix under real-time EUS guidance. Cyanoacrylate injection (Histoacryl, B. Braun Surgical, Germany) will be performed according to established protocol. Each aliquot of cyanoacrylate injection will consist of 0.5ml of Histoacryl + 0.7ml of lipiodol. 1 - 3 aliquots of cyanoacrylate injection may be given depending on the number of varices needed to be treated. EUS with colour Doppler will be used to monitor obliteration of blood flow in varices during and after cyanoacrylate injection.
16029183|NCT02672306|Biological|UCMSCs|Biological: Human UCMSCs 20 million cells per subject (0.5×10^6 UCMSCs per kg) intravenous injection Infusion number: 8 (Once every two weeks)
16029184|NCT02672306|Biological|Placebo|Subjects with Alzheimer's Disease placebo comparator (normal saline) intravenous injection Infusion number: 8 (Once every two weeks)
16029185|NCT02672293|Drug|Phoslax|Oral sodium phosphate solution (monobasic sodium phosphate 2.4 g and dibasic sodium phosphate 0.9g / 5 mL).
16029186|NCT02672280|Device|Medical Collagen Membrane with MSC|
16029187|NCT02672280|Device|Medical Collagen Membrane|
16029188|NCT02672267|Biological|Stem cells|human Allogeneic Low Oxygen mesenchymal stem cells; Ischemia tolerant
16029189|NCT02672267|Other|Placebo|Lactated Ringer's Solution
16029190|NCT02672254|Radiation|Samples with 2 treatments|Study the concomitant effects between chemo- and radiotherapy by means of cellular techniques.
16029191|NCT02672241|Drug|Nimotuzumab|Nimotuzumab given during radiotherapy, is administered via intravenous drip with a dosage of 150mg/m2, weekly, for 6 consecutive weeks. After radiotherapy and evaluation, disease progression-free patients will continue to receive Nimotuzumab treatment biweekly until disease relapse or progression.
16029192|NCT02672241|Drug|Temozolomide|Temozolomide is applied to these patients as a chemotherapy drug with a dosage of 75mg/m2, daily. The chemotherapy and radiation are combined as temozolomide is taken 1 hour prior to every fraction of radiotherapy. In 4 weeks after the completion of radiotherapy, temozolomide is given for 8 cycles (dosage: the 1st cycle, 150mg/m2, daily × 5 days, 4 weeks a cycle; the 2-8th cycle, 200mg/m2, daily × 5 days, 4 weeks a cycle and repeated again).
16029193|NCT02672228|Device|MalariaSense device|All participants enrolled in the study will be assessed for malaria using the intervention device called MalariaSense technology
16029194|NCT02672215|Behavioral|Start to stand|web-based computer-tailored intervention including personalized feedback and tips on how to reduce and/or interrupt workplace sitting
16029195|NCT02672215|Behavioral|generic advice|general, non-tailored web-based generic advice with tips
16029196|NCT02672202|Drug|Duloxetine|"60 mg/d - twice before surgery and once a day for post operative days 3-7
~30 mg/d - once a day for post operative days 1-2"
16029197|NCT02672202|Drug|Pregabalin|"75 mg/d - twice a day for post operative days 1-2
~150 mg/d - twice a day for post operative days 3-7 300 mg/d - twice before surgery"
16029198|NCT02672202|Drug|Placebo|"non-active - twice before surgery
~non-active - twice a day for post operative days 1-7"
16029199|NCT02672189|Behavioral|EVA-Online|Internet-based cognitive behavioral therapy
16029200|NCT02672176|Behavioral|Usual Care|This program is a well-established program within the UC Davis Health System, providing care coordination to individuals with chronic conditions. Patients can self-refer or are referred by their providers for this service. The role of the care coordinator is to assess needs of the patient and coordinate healthcare referrals and appointments for the patient, facilitate communication among members of the healthcare team, identify health goals in collaboration with the patient and assist them in meeting those goals if requested by the patient. Contact is variable and conducted on a case by case basis.
16029201|NCT02672176|Behavioral|P2E2T2 Program|The P2E2T2 intervention group will receive Nurse Health Coaching using MI, an approach designed to elicit and support behavioral changes and improve self-efficacy (18-21). Nurses delivering the intervention will have completed the Health Science Institutes Registered Health Coach (RHC) training program (www.healthsciences.org). The intervention protocol is as follows:
16029202|NCT02672163|Procedure|CABG surgery|Elective CABG surgery
16029203|NCT02672163|Procedure|AADC therapy|Atrial appendage derived cells are placed on the site of a infarct scar with matrix sheet
16029204|NCT02672150|Behavioral|Core|
16029205|NCT02672150|Behavioral|Enhanced|
16029206|NCT02672137|Behavioral|knowledge translation|knowledge translation that include: Community of practice, local gap analysis, opinion leaders, targeted interventions, performance feedback, reminders and local formation of ACS teams.
16029207|NCT02672111|Drug|CAM2038 q1w or q4w exposure to SL BPN/NX|
16029208|NCT02672111|Drug|CAM2038 q1w or q4w new to BPN treatment|
16029209|NCT02672098|Procedure|Hyperthermic intraperitoneal chemotherapy (HIPEC)|Hyperthermic intraperitoneal chemotherapy (HIPEC) is a procedure in which the internal parts of the abdomen are bathed in a warm solution of anti-cancer medications for 90 minutes.
16029210|NCT02672098|Drug|Carboplatin|"Carboplatin, delivered as HIPEC, will be administered at the time of surgery. Subjects will receive a single cycle of hyperthermic intraperitoneal chemotherapy.
~a single dose of carboplatin (800 mg/m2) will be administered in normal saline via intraperitoneal hyperthermic perfusion using the closed-abdomen technique. HIPEC will be continued for 90 minutes in the hyperthermic phase (41°C-43°C)."
16029211|NCT02672085|Procedure|PRP infiltraiton|Two time with 1 month interval, PRP will be extracted from own blood's patients with Regenlab® extraction kit, and injected into supraspinatus interstitial lesion.
16029212|NCT02672085|Procedure|Needling|Two time with 1 month interval, saline water will be injected into supraspinatus interstitial lesion.
16029218|NCT02672033|Radiation|Hypofractionated Radiation Therapy|Undergo accelerated hypofractionated IMRT
16029219|NCT02672033|Radiation|Intensity-Modulated Radiation Therapy|Undergo accelerated hypofractionated IMRT
16029220|NCT02672033|Other|Laboratory Biomarker Analysis|Correlative studies
16029221|NCT02672033|Procedure|Therapeutic Conventional Surgery|Undergo pleurectomy/decortication
16029222|NCT02672020|Biological|omics identity card|
16029223|NCT02672007|Device|SensiumVitals|The patients will have their respiratory rates, heart rates and temperature (axilla) measured continuously by the SensiumVitals patch.
16029224|NCT02671994|Other|G8 screening|
16029225|NCT02671994|Other|Geriatric assessment|
16029226|NCT02671968|Device|Continuous Glucose Monitoring System|
16029227|NCT02671955|Drug|JNJ-61610588|Participants will receive intravenous infusions of JNJ-61610588 until disease progression.
16029228|NCT02671942|Drug|Roflumilast|
16029229|NCT02671942|Drug|Placebo|
16029230|NCT02671929|Behavioral|self-help program|Access to the internet-based self-help program
16029231|NCT02671929|Behavioral|therapeutic feedback|Therapeutic feedback on the written information sent to the online therapist
16029232|NCT02671916|Behavioral|questionnaire|Investigation on all study patients, no Intervention, no groups
16029233|NCT02671903|Device|Pacemaker: AV optimised, His pacing.|Direct His bundle pacing: a Medtronic Select Secure 3830 pacing lead will be positioned at the His bundle. If selective direct His bundle pacing cannot be achieved then non-selective His bundle pacing will be accepted. AV delay optimisation: will be performed using acute non-invasive blood pressure acquired using the Finometer device (Finapres Medical systems, Netherlands).
16029234|NCT02671890|Drug|Chemotherapy|
16029235|NCT02671890|Drug|Disulfiram|Given PO
16029236|NCT02671890|Drug|Gemcitabine Hydrochloride|Given IV
16029237|NCT02671890|Other|Laboratory Biomarker Analysis|Correlative studies
16029238|NCT02671890|Other|Placebo Administration|Given PO
16029239|NCT02671877|Procedure|Transnasal fiberoscopy|Minimally invasive exploration ot the upper airways, performed in an awake or minimally sedated patient.
16029240|NCT02671864|Other|1: incretin-based therapy|
16029241|NCT02671864|Other|2: other antidiabetic|
16029242|NCT02671851|Drug|Thoracic paravertebral blocks (TPVBs)|Patients received bilateral single injection ultrasound-guided TPVBs with 20mL bupivacaine 0.375% at the level of T3-T4 as an adjunct to GA, intraoperative fentanyl and postoperative tramadol, metamizole sodium and paracetamol were used.
16029243|NCT02671851|Drug|IV metamizole sodium, paracetamol|Patients received only standardized GA, intraoperative fentanyl and postoperative tramadol, metamizole sodium and paracetamol were used.
16029244|NCT02671838|Behavioral|Musculoskeletal ultrasound program|Using a musculoskeletal ultrasound program to help improve medication adherence
16029245|NCT02671825|Drug|PUR0200|PUR0200 dry powder inhalation
16029246|NCT02671825|Drug|Reference Product|Dry Powder Inhalation Reference Product
16029247|NCT02671799|Device|VenTouch System Implant|The VenTouch System is intended for use in the treatment of functional MR (FMR) in adults who are symptomatic despite optimal medical management. It is intended for subjects with FMR with essentially normal leaflet anatomy and motion, with mitral valve regurgitation attributable mainly to annular dilatation with or without papillary muscle displacement. It is not intended to treat structural defects/degeneration of the mitral valve. The VenTouch System is used to reshape the base of the heart to bring the mitral valve leaflets into better coaptation. By doing so, it brings the mitral valve leaflets closer, allowing proper closure of the valve, and reducing or eliminating MR. There is provision of support to the ventricular myocardium below the annulus as well as the annulus, so the VenTouch System may allow long-term ventricular remodeling with positive impact on the functionality of the mitral valve.
16029248|NCT02671786|Other|MAHAN RUTF & MAHAN Vit-Min mix|MAHAN RUTF dishes are locally prepared by local tribal women and each packet of RUTF provides 500-550 calories & 15-17 gms of proteins.
16029249|NCT02671773|Drug|Inhaled corticosteroid dose/type|
16029250|NCT02671760|Drug|SM-1|3-drug combination product containing 50 mg diphenhydramine, 5 mg zolpidem and 0.5 mg lorazepam
16029251|NCT02671760|Drug|Comparator|2-drug combination comprised of 5 mg zolpidem and 0.5 mg lorazepam
16029252|NCT02671760|Drug|Placebo|Placebo
16029253|NCT02671747|Behavioral|Mind Over Matter; Healthy Bowels, Healthy Bladder|3 workshop sessions over a one-month period using self-efficacy and health behavior change to improve incontinence symptoms and promote care-seeking if symptoms do not improve sufficiently
16029254|NCT02671734|Behavioral|video|Short (2 minute 43 second), animated videos were designed addressing nature of the procedure, risks, benefits, and alternatives for upper and lower endoscopy respectively using PowToon (www.powtoon.com). Sixth grade language was used throughout the video. Videos were shown to youth and their parents on an iPad.
16029255|NCT02671721|Other|Maximal Compliance|PEEP will be set at the maximum static respiratory system compliance during a descending PEEP titration curve.
16029256|NCT02671721|Other|Transpulmonary Pressure|We will use transpulmonary pressure values obtained using an naso/orogastric tube during the operative procedure to titrate PEEP intraoperatively.
16029257|NCT02671708|Drug|Idarubicin（IDA）|Idarubicin was administered at 15mg/m2/day on days -12 and -10.
16029258|NCT02671708|Drug|Busulfan (BU)|Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.
16029259|NCT02671708|Drug|Cyclophosphamide (CY)|Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
16029260|NCT02671695|Drug|Spirulina|Spirulina capsules (500 mg) in a dose of 250 mg/kg/day orally for 3 months
16029261|NCT02671695|Drug|Amlodipine|Amlodipine in a dose of 5 mg/day orally for 3 months
16029262|NCT02671682|Procedure|Immunoadsorption|
16029263|NCT02671682|Procedure|Plasmapheresis|
16029264|NCT02671669|Behavioral|Usual Care|Discharge packet of Heart Healthy instructions, with self-report health status, quality of life and psychosocial questionnaires, as well as other educational handouts, exit interview to review exercise progress, receive referrals to additional medical services they might need after discharge from the program, with physician.
16029332|NCT02671123|Procedure|Coronary PCI with OCT without Co Registration|Coronary PCI will be performed using OCT ( Optical Coherence Tomography intravascular system) guidance without the Co Registration software tool enabled.
16029265|NCT02671669|Behavioral|Movn application (MVN)|"Intervention participants will receive the same discharge packet as the UC group along with their exit interview and will receive the following:
~Participant individualized Heart Healthy instructions for post-cardiac rehabilitation will be integrated into the MVN application including daily medication reminders, physical activity prompts, educational materials, and patient-reported outcome assessment of behavior and psychosocial status.
~Text messages will be used on an ad hoc basis to provide positive feedback to the participant; two-way messaging between the participant and the research coordinator will be available to provide opportunities to answer specific questions."
16029266|NCT02671656|Device|Uricemia|serum uric acid levels is measured once from venous blood samples in the biochemistry laboratory using standard automated colorimetric methods
16029267|NCT02671630|Other|A community-based computerized cognitive training program|The computer training games included: 1) a phonological loop to train the participants to choose correct song from a list of different songs which can be categorized as people, nature, and musical instrument. The difficulty level progressed from choosing one from two to choosing one from three songs; 2) a visual-spatial sketchpad to train the participants to remember and find the same graphs including vegetable, fruits, daily necessity, and numbers. The difficulty level progressed from finding one pair to three pairs of similar graphs; 3) a central executive system to train the participants to execute dual tasks including conducting dual memory, calculating while listening to music, making phone calls, and matching medication at correct time.
16029268|NCT02671617|Other|High intensity interval training (HIIT)|Preoperative HIIT protocol.
16029269|NCT02671591|Behavioral|MI-PrEP|This is a one-hour motivational interviewing-based, one-to-one session that will help YBMSM think more about going on PrEP and it will help YBMSM think more about using condoms consistently and correctly with every sex partner.
16029270|NCT02671591|Behavioral|control condition|This is a behavioral program designed to provide men with condoms and lubricants that make sex feel good even though it is fully protected by latex condoms
16029271|NCT02671578|Drug|Nitrous Oxide|The N2O/O2 equipment was composed by two flow meters with an anti-hypoxia system valve, 70% N2O maximum disposal and 30 L/min O2 valve to immediate oxygen dispensation. Masks were individually selected, being 100% O2 (6 L/min) dispensed until respiratory rate stabilization. N2O was incremented at 10% each 2 minutes (70% max, if necessary) until some of the following signals were noticed: silence, relax/comfort report, decreased eyelid movements, decreased spontaneous body movements, warm sensation, tingling sensation or numbness at feet, hands or oral region, and slightly euphoric sensation.
16029272|NCT02671565|Drug|Hyaluronic Acid injections|
16029273|NCT02671552|Drug|Perflutren Protein-Type A Microspheres|Given IV
16029274|NCT02671552|Procedure|Dynamic Contrast-Enhanced Ultrasound Imaging|Undergo contrast-enhanced ultrasound imaging
16029275|NCT02671539|Genetic|rAAV2.REP1|single subretinal injection
16029276|NCT02671526|Other|Computerized plasticity-based adaptive cognitive training|
16029277|NCT02671513|Drug|SHR6390|SHR6390 either 50mg,75mg,100mg,125mg,150mg,175mg given orally, QD
16029278|NCT02671500|Drug|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily
16029279|NCT02671487|Behavioral|Mind-Body Skills Groups|Mind-Body Skills groups consist of small groups of about 8-10 participants who learn and practice meditation, guided imagery, breathing techniques, autogenic training, biofeedback, genograms, and self-expression through words, drawings, and movement.
16029280|NCT02671474|Other|4-dimensional volume-rendered computed tomography|
16029281|NCT02671461|Drug|BMS-986141|
16029282|NCT02671461|Drug|Aspirin|
16029283|NCT02671461|Other|Placebo|
16029284|NCT02671448|Behavioral|Home monitoring teleconsult visits|A tablet will be provided to both the patient and the caregiver during the homecare portion of the study. The tablet will remain at the home, to be used by the patient and the caregiver during daily homecare visits to complete instruments/surveys and video diary recording sessions.
16029285|NCT02671448|Behavioral|Patient Reported Outcomes (PRO)|Distress Thermometer, MSK-Modified M.D. Anderson Symptom Inventory (MDASI) Instrument, FACT-G Instrument, FACT-BMT Instrument
16029286|NCT02671448|Behavioral|Caregiver Reported Outcomes instruments|Distress Thermometer, Caregiver Reaction Assessment (CRA) Instrument, The Caregiver Quality of Life Index-Cancer (CQOLC) Scale, Satisfaction Questionnaire, Video Diary Entries
16029287|NCT02671435|Combination Product|Intervention|Biological: Durvalumab Biological: Monalizumab Biological: Cetuximab
16029288|NCT02671409|Other|Neural Mobilization (exercise)|Initially patients will be informed about the procedures. After the guidelines, the hip and knee are palpated to start the joint angles. Then, the knee joint is positioned in extension and remained so throughout the treatment. In addition, the hip joint is bent until the moment that will be perceived a minimum strength of the muscles of the posterior region of thigh and leg (discarding muscle stretching). Neural mobilization is started at the time when the ankle joint will be manipulated in dorsiflexion at a frequency of approximately 20 oscillations per minute, with a pause of 25 seconds of rest. In the last two minutes of therapy, we will include cervical flexion, in order to intend the neuraxis, keeping artuculares amplitudes.
16029289|NCT02671396|Behavioral|Virtual reality based intervention|Virtual reality based balance training
16029290|NCT02671396|Behavioral|Conventional intervention|Conventional balance training
16029291|NCT02671383|Drug|Darunavir|Darunavir/ritonavir 400/100mg (DRV/r) once daily plus nucleoside/nucleotide reverse transcriptase inhibitors.
16029292|NCT02671383|Drug|Lopinavir|Lopinavir/ritonavir 400/100mg (LPV/r) twice daily plus nucleoside/nucleotide reverse transcriptase inhibitors.
16029293|NCT02671370|Other|Measurement of the range of motion of the cervical spine|There is no intervention. Only measurements and interviews are taken.
16029294|NCT02671357|Procedure|ERAMIP|3D-LPD with stented umbrella-pancreaticogastrostomy & Roux-en-Y reconstruction of the biliary limb of the hepatico-jejunostomy onto the efferent limb of the gastro-enterostomy (RY-GES)
16029295|NCT02671344|Other|Determination of gene profiles using arrays semen|Determination of gene profiles characterizing the set of mRNA and functional interpretation of the resulting list of genes.
16029331|NCT02671123|Procedure|Coronary PCI with OCT with Co Registration|Co-Registration is an online tool used to take measurements during a stent procedure ( PCI-percutaneous coronary intervention) as part of the OCT ( Optical Coherence Tomography intravascular system. Co Registration software may provide additional imaging details during stent implantation when using OCT.
16135138|NCT01896349|Drug|trazodone|
16029296|NCT02671331|Procedure|Loop duodenal switch|The loop duodenal switch (L-DS) is a single anastomosis duodeno-intestinal bypass. In this simplified version of a BPD-DS, a sleeve gastrectomy is followed by a single anastomosis of the duodenum to the ileum in a loop fashion. The proposed benefits of this are to reproduce the excellent weight loss seen after a BPD-DS (an accepted and utilized bariatric procedure in the USA) but with the potential for reduced complications. With one anastomoses in the L-DS over two in the BPD-DS there is a theoretical lower probability of leaks, strictures, reduced anesthesia with shorter operative times, and decreased risk of internal hernia.
16029297|NCT02671318|Drug|Drug conversion to sirolimus|Drug conversion to sirolimus: mycophenolate or azathioprine conversion to sirolimus, in a regimen with tacrolimus and prednisone.
16029298|NCT02671318|Drug|Maintenance of the current regimen|Maintenance of the current regimen: mycophenolate or azathioprine maintenance, in a regimen with tacrolimus and prednisone.
16029299|NCT02671305|Procedure|placental circulation intact|bedside assistance with placental circulation intact during first 3 minutes of life
16029300|NCT02671305|Procedure|cord milking|neonatal assistance in a standard setting after cord milking (milking four times 20 cm of cord)
16029301|NCT02671292|Behavioral|Interpersonal Psychotherapy|IPT-WG involves one initial 1.5-hour individual session, and 12 weekly 90-minute group sessions. The IPT-WG group sessions follow 3 phases (initial, middle, and termination) and use the interpersonal inventory to identify interpersonal problems that might be contributing to or exacerbated by LOC eating. A framework of common problem areas is used to teach interpersonal problem-solving and communication skills and educate youth about risk factors for excessive weight gain and warning signs such as eating in response to negative affect as opposed to hunger, or feeling a sense of LOC while eating.
16029302|NCT02671292|Other|Health Education|"The HE group is based upon the HEY-Durham health program designed by researchers at Duke University. This program, designed to be delivered to youth attending community high schools, was adapted to a 12-week program (each session is 90 minutes). Additionally, individuals will attend a pre-group individual meeting with the group leaders to review family health history.The curriculum includes focus on various health topics, including alcohol, drug and tobacco use, depression and suicide, nutrition and body image, nonviolent conflict resolution, sun safety, exercise, and domestic violence. Session content will be largely identical for boys and girls, with the exception of gender-specific videos and articles (e.g., on body image), which will be tailored for each sex."
16029303|NCT02671279|Dietary Supplement|Low calorie diet|6 days of low calorie diet, estimated kcal 400-600/day.
16029304|NCT02671266|Drug|Oxytocin|Oxytocin nasal sprays will be self-administered in the presence of a study nurse. The dose is 24 IU (3 puffs per nostril, 4 IU per puff) of Syntocinon nasal spray.
16029305|NCT02671266|Drug|Placebo|Placebo nasal sprays will be self-administered in the presence of a study nurse. The sprays will contain all of the same ingredients as the Syntocinon spray minus the active oxytocin ingredient.
16029306|NCT02671253|Procedure|Myomectomy|The patient series consists of consecutive patients scheduled for elective laparotomic, traditional laparoscopic or robotic assisted laparoscopic myomectomy. The surgical method is selected based on clinician´s preference.
16029307|NCT02671227|Drug|intrathecal Mg sulfate.|intrathecal Mg sulfate 50 mg.
16029308|NCT02671227|Drug|intrathecal bupivacaine 15 mg.|intrathecal bupivacaine 15 mg.
16029309|NCT02671214|Other|Control|100 g high fibre flour
16029310|NCT02671214|Other|Active 2|98 g high fibre flour + 2 g guar gum
16029311|NCT02671214|Other|Active 3|88 g high fibre flour + 2 g guar gum + 10 g legume flour
16029312|NCT02671214|Other|Active 4|83 g high fibre flour + 2 g guar gum + 15 g legume flour
16029313|NCT02671214|Other|Active 5|96 g high fibre flour + 4 g guar gum
16029314|NCT02671214|Other|Active 6|86 g high fibre flour + 4 g guar gum + 10 g legume flour
16029315|NCT02671214|Other|Active 7|81 g high fibre flour + 4 g guar gum + 15 g legume flour
16029316|NCT02671214|Other|Active 8|94 g high fibre flour + 6 g guar gum
16029317|NCT02671214|Other|Active 9|98 g high fibre flour + 2 g konjac mannan
16029318|NCT02671214|Other|Active 10|96 g high fibre flour + 4 g konjac mannan
16029319|NCT02671214|Other|Active 11|100 g low fibre flour
16029320|NCT02671214|Other|Active 1|85 g high fibre flour + 15 g legume flour
16029321|NCT02671201|Other|Education|Different methods in education of emergency ultrasound
16029322|NCT02671188|Drug|GSK3050002|The 3 mL glass vial contains white to off-white lyophilized powder which requires reconstitution with sterile water for injection.Prepared as 100 milligrams per milliliter (mg/mL) solution; lower concentrations prepared by dilution with 0.9% weight by volume (w/v) sodium chloride Injection for infusion.
16029323|NCT02671188|Drug|Placebo|Normal saline (0.9% sodium chloride) will be used as placebo.
16029324|NCT02671175|Drug|dihydroartemisinin-piperaquine|Children in both arms will receive standard in-hospital care for severe anaemia (blood transfusion, often combined with quinine or artesunate IV/IM). All children will then receive a 3-day course of AL (whether they initially had malaria or not), which will be started in-hospital as soon as they are able to take oral medication, and will be completed at home after discharge. At 2 weeks after enrolment surviving children will be randomized to receive either a standard 3-day courses of dihydroartemisinin-piperaquine (Eurartesim®, Sigma Tau, Italy) or an identical placebo regimen at 2, 6 and 10 weeks after enrolment.
16029325|NCT02671175|Drug|dihydroartemisinin-piperaquine placebo|Children will receive standard in-hospital care for severe anaemia (blood transfusion, often combined with quinine or artesunate IV/IM). All children will then receive a 3-day course of AL (whether they initially had malaria or not), which will be started in-hospital as soon as they are able to take oral medication, and will be completed at home after discharge. At 2 weeks after enrolment surviving children will be randomized to receive either a standard 3-day courses of dihydroartemisinin-piperaquine (Eurartesim®, Sigma Tau, Italy) or an identical placebo regimen at 2, 6 and 10 weeks after enrolment.
16029326|NCT02671162|Drug|Wheat|3 times a day each time 2 capsules before eating meal for 8 weeks.
16029327|NCT02671162|Drug|Fumaria|3 times a day each time 2 capsules before eating meal for 8 weeks.
16029328|NCT02671149|Dietary Supplement|Water|Participants will receive two cups of 150ml plain water
16029329|NCT02671136|Device|Hyperbaric Oxygen therapy|
16029330|NCT02671136|Other|Conventional Wound Therapies|
16029333|NCT02671110|Behavioral|Transforming Your Life|See Transforming Your Life Arm
16029334|NCT02671110|Behavioral|Diabetes Prevention Program|See Diabetes Prevention Program Arm
16029335|NCT02671097|Drug|Rosuvastatin|5 mg tablet single dose on Day 01 in Period 1 and on Day 08 in Period 2.
16029336|NCT02671097|Drug|BAY1841788 (ODM-201)|600 mg single dose, administered as 2 x 300 mg tablets on Day 01 in Period 2; 600 mg BID multiple dose, administered as 2 x 300 mg tablets on Day 04 to Day 08 in Period 2.
16029337|NCT02671084|Drug|sevoflurane|compare effect of sevoflurane when administered before PCI
16029338|NCT02671071|Behavioral|Quality of Life Questionnaire (QLQ)|The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Cervical cancer module (EORTC QLQ-CX24) will be applied to all patients at 0, 3, 6, 12, 24, 36 months.
16029339|NCT02671058|Drug|Cortenema|Hydrocortisone Administered as a Liquid Enema
16029340|NCT02671058|Drug|Hydrocortisone Acetate|Hydrocortisone Acetate Administered as a Suppository with the Sephure® Rectal Suppository Applicator
16029341|NCT02671045|Genetic|Genomic profile by FoundationOne|Proprietary comprehensive genomic profile.
16029342|NCT02671045|Genetic|Genomic profile by other methods|Genomic profiling by other testing methods.
16029343|NCT02671032|Device|Nucleus CI532 cochlear implant|
16029344|NCT02671019|Behavioral|Guide to better alcohol habits|A treatment for harmful alcohol use based on Motivational Interviewing, Cognitive Behavioral Treatment and Relapse prevention, focusing on: Motivation to change harmful alcohol use, defining a goal for the treatment, self-control strategies, risk situations, planning alternative behaviors and relapse prevention.
16029345|NCT02671006|Other|Basophil patterns|The Basophil patterns (CUBIC) will be compared between patients with urticaria and controls without Chronic Urticaria.
16029346|NCT02670993|Behavioral|Singing sessions.|Patients will be in singing work groups, and will participate to these sessions during 12 weeks, with one session per week of 2 hours.
16029347|NCT02670993|Behavioral|Painting sessions.|Patients will be in painting groups, they will participate to this work session during 12 weeks, with one session of 2 hours per week.
16029348|NCT02670980|Device|Intelligent Retinal Implant System|
16029349|NCT02670967|Dietary Supplement|Soluble Fibre|
16029350|NCT02670954|Drug|Dexmedetomidine, tramadol and flurbiprofen|
16029351|NCT02670954|Drug|tramadol and flurbiprofen|
16029352|NCT02670941|Drug|Ginger|The ginger oil (GIN-106) was steam distilled from fresh ginger grown in Madagascar. The ginger oil contains 64.23% sesquiterpenes, 18.5% monoterpenes, and 3.28% aldehydes. The aroma of ginger is described as spicy, sweet, and warm.
16029353|NCT02670941|Drug|Lavender|The lavender oil (LAV-110) was steam distilled from lavender grown in Kashmir Valley in India. The lavender oil contains 53.22% esters, 31.86% monoterpenols, and 4.88% oxides. The aroma of lavender is described as floral, fresh, herbaceous, and sweet.
16029354|NCT02670941|Drug|Orange|The orange oil (ORG-114) was cold-pressed and steam distilled from oranges in South Africa. The orange oil contains 97.21% monoterpenes, 0.73% aldehydes, and 0.7% monoterpenols. The aroma of orange is described as citrus, fresh, fruity, and sweet.
16029355|NCT02670941|Drug|Jojoba|"The jojoba oil is certified organic and pesticide-free pure oil. Jojoba has a mild scent and can be used as a fixative for other essential oils."
16029356|NCT02670928|Behavioral|Lifestyle intervention|Patients of active group were assigned to receive activities of the program for life style changes. Patients in control group were managed in frames of routine clinical practice. No any investigational drug therapy was used.
16029357|NCT02670915|Drug|Faster-acting insulin aspart|For subcutaneous (s.c., under the skin) injection once daily.
16029358|NCT02670915|Drug|insulin aspart|For subcutaneous (s.c., under the skin) injection once daily.
16029359|NCT02670915|Drug|insulin degludec|For subcutaneous (s.c., under the skin) injection once daily.
16029360|NCT02670902|Behavioral|Critical Time Intervention-Residential (CTI-R)|CTI-R is a 9-month, time-limited intervention that aims to produce an enduring impact by effectively linking individuals to both professional services (substance abuse and health and mental health providers) and social supports (e.g., family and friends) and by providing emotional and practical support. Participants in the CTI-R condition will also receive usual discharge services from the residential substance abuse treatment program.
16029361|NCT02670902|Behavioral|Enhanced Usual Discharge Services-Residential|The enhanced usual discharge condition encompasses the regular discharge services offered at the residential treatment program, as well as three telephone recovery check-up calls post-discharge.
16029362|NCT02670876|Behavioral|Anti-bullying intervention|"The title of each session were as follows :
~Introduction of intervention and setting rules, building rapport
~Understanding school bullying (The definition of school bullying and proper coping strategies)
~Empathy of others ( Practice of understanding victims of school bullying)
~Impulse control 1 (Understanding my anger patterns, finding one's true feelings behind that anger)
~Impulse control 2 (Finding irrational thoughts that lead to anger and correction of them)
~Conflict management (Understanding one's pattern of dealing with conflicts, finding effective strategies)
~Communication skills enhancement
~Increasing self esteem"
16029363|NCT02670863|Other|Experimental Infant Formula|Standard bovine milk-based term infant formula supplemented with a prebiotic, fed ad libitum
16029364|NCT02670863|Other|Standard Infant Formula|Standard bovine milk-based term infant formula, fed ad libitum
16029365|NCT02670850|Other|Family Caregiver Intervention Program|Family Caregiver Intervention Program included three components: introduction of mild cognitive impairment, maintain and improve cognitive function, and health management.
16029366|NCT02670837|Device|Cellutome Epidermal Harvesting System|
16029367|NCT02670824|Drug|CN-105|Single and multiple intravenous (IV) doses of CN-105
16029368|NCT02670824|Drug|Placebo|Normal Saline
16029369|NCT02670811|Dietary Supplement|Fermented milk|150 mL daily of fermented milk with Lactococcus lactis NRRL-B50571
16029370|NCT02670811|Dietary Supplement|Acidified milk|150 mL daily of artificially acidified milk
16029371|NCT02670798|Procedure|Thromboelastography laboratory testing|Laboratory test that monitors clotting properties of blood
16029372|NCT02670785|Drug|Estradiol Vaginal Capsule (EVC)|Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
16029373|NCT02670785|Drug|Placebo|Administered intravaginally once daily for 2 weeks and then once weekly for 4 weeks
16029411|NCT02670473|Device|fanfilcon A (test)|contact lens
16135139|NCT01896349|Drug|Mirtazapine|
16029374|NCT02670772|Drug|Stavudine|Stavudine 20mg twice daily for 96 weeks + Placebo 300mg once daily for 96 weeks + Lamivudine 150mg twice daily for 96 weeks + Efavirenz 600mg once daily for 96 weeks
16029375|NCT02670772|Drug|Tenofovir Disoproxil Fumarate|TDF 300mg once daily + Placebo 20mg twice daily for 96 weeks + Lamivudine 150mg twice daily for 96 weeks + Efavirenz 600mg once daily for 96 weeks
16029376|NCT02670759|Drug|Continuous infusion of bupivacaine|The infusion of local anesthetics will be initiated using a conventional infusion pump and will be transferred on a portable elastomeric pump before discharge from the hospital if the patient is discharged the day after surgery or at the latest on the second morning following surgery. The infusion will continue on the portable pump for 30 hours.
16029377|NCT02670759|Drug|Single dose of bupivacaine|A single dose of bupivacaine will be administered at the end of surgery before skin closure.
16029378|NCT02670733|Procedure|Positive end-expiratory pressure|Positive end-expiratory pressure will be applied at 5 cmH2O and 15 cmH2O
16029379|NCT02670720|Drug|avoralstat|
16029380|NCT02670707|Drug|Cytarabine|Cytarabine 100 mg/m^2/day IV for five consecutive days. This five-day cycle will be repeated every 21 days for a total of four cycles for all patients regardless of response. Each new cycle may not begin until absolute neutrophil count (ANC) is ≥ 750/mcL and platelet count is ≥ 75,000/mcL.
16029381|NCT02670707|Drug|Vinblastine/prednisone|"Vinblastine/Prednisone +/- 6-mercaptopurine based on risk category. Patients with high-risk organ involvement (liver, spleen, hematopoeitic system) will receive 6-mercaptopurine during Continuation Therapy as this is the current standard of care treatment.
~Vinblastine 6 mg/m^2/dose IV push weekly for patients ≥ 12 months of age. Vinblastine will be dosed at 3 mg/m^2/dose for patients under 6 months of age, and dosed at 4.5 mg/m^2/dose for patients 6 months of age to 11.99 months of age.
~Prednisone (or prednisolone) 20 mg/m2/dose by mouth twice a day"
16029382|NCT02670681|Behavioral|Aerobic Exercise Training|8 week of aerobic exercise training in different intensities.
16029383|NCT02670668|Other|Mutation analysis|
16029384|NCT02670655|Drug|lidocaine/prilocaine (5%) application|For AFL pre-treatment, lidocaine/prilocaine (5%) cream (EMLA; Astra Pharmaceuticals, LP, Westborough, MA, USA) was applied to the treatment area under occlusion for 30 min
16029385|NCT02670655|Device|2940-nm Er:YAG AFL pretreatment|After the anaesthetic cream was removed, AFL therapy was performed using a 2940-nm Er:YAG AFL (Joule; Sciton Inc., Palo Alto, CA, USA) at 300-550 µm ablation depth, level 1 coagulation, 22% treatment density and a single pulse
16029386|NCT02670655|Drug|MAL application|Immediately after AFL treatment, an approximately 1-mm-thick layer of MAL (Metvix, PhotoCure ASA, Oslo, Norway) was applied to the lesion and on 5 mm of surrounding normal tissue.
16029387|NCT02670655|Device|Iontophoresis application|In Group A, ionotophoresis was performed on MAL-applied sites. We used iontophoresis (vitaliont II®, ITC Inc, Korea) with a patch. The active electrode was the anode, and 0.50-mA/cm2 current was applied to each AK lesion for 10 min.
16029388|NCT02670655|Device|irradiation with red light-emitting diode lamp|After incubation for 2 (Group A and B) or 3 hours (Group C), the dressing and cream were removed, and the area was cleansed with saline. The area was irradiated with a red light-emitting diode lamp (Aktilite CL 128; PhotoCure ASA, Oslo, Norway) with peak emission at 632 nm, placed 5 cm away from the skin surface, and a total light dose of 37 J/cm-2. All patients wore protective goggles during illumination.
16029389|NCT02670642|Drug|Esomeprazole|Proton pump inhibitor
16029390|NCT02670629|Procedure|Partial reduction with overriding position|The patient was subjected to an alignment instead of an anatomic reduction; this means that the fracture was left in an overriding position, after this, the patient was placed in a short arm cast for 6 weeks.
16029391|NCT02670629|Procedure|Closed anatomic reduction|The patient was subjected to an anatomic reduction; this means that the fracture was completely reduced, after this, the patient was placed in a short arm cast for 6 weeks.
16029392|NCT02670616|Drug|Ibrutinib|560 mg by mouth daily on day 1-21 per each cycle
16029393|NCT02670616|Drug|Rituximab|375 mg/m2 IV, day 1
16029394|NCT02670616|Drug|Cyclophosphamide|750 mg/m2 IV day 1
16029395|NCT02670616|Drug|Doxorubicin|50 mg/m2 IV day 1
16029396|NCT02670616|Drug|vincristine|1.4 mg/m2 IV on day 1
16029397|NCT02670616|Drug|Prednisolone|100mg per day on day 1-5
16029398|NCT02670603|Drug|EVONAIL® solution|
16029399|NCT02670590|Behavioral|diet|diet
16029400|NCT02670564|Genetic|Pharmacogenomics|"Blood samples (2x5ml EDTA tubes) should be collected just before the start of the conditioning regimen from every patient regardless of therapeutic arm by every centre and stored ≤-20°C Patient should be in remission (MRD negative) for this sampling, otherwise the sample should be taken using a mouth swab/saliva (not intravenously).
~For second transplant patients, please provide DNA taken before first transplant or a fresh saliva samples."
16029401|NCT02670564|Other|Busulfan plasma level measurements|"Bu PK analysis after the first dose of IV Bu (+potential subsequent ones).
~Blood sampling:
~->For Bu 4 X/d: Before the first Bu dose (Time 0), then straight after the end of infusion (Time 1), then at 15 min (Time 2), 30 min (Time 3), 1 hour (Time 4) and 4 hour (Time 5) after the end of infusion
~->For Bu 1 X/d: Before the first Bu dose (Time 0), then straight after the end of infusion (Time 1), then at 1 hour (Time 2), 3 hour (Time 3), 5 hour (Time 4), 7 hour (Time 5) and 11 hour (Time 6) after the end of infusion.
~For centers not performing BU TDM, perform Dried Blood Sampling (DBS) analysis:
~-> 0.5ml blood sample should be collected and 5µl spotted onto DBS cards in duplicate. Dry them max 5 hours and then keep in a sealed envelope and store at -80°C, as below"
16029402|NCT02670551|Drug|Cariprazine|
16029403|NCT02670551|Drug|Placebo|
16029404|NCT02670538|Drug|Cariprazine|Cariprazine capsule one per day orally.
16029405|NCT02670538|Drug|Placebo|Matching placebo capsule one per day orally.
16029406|NCT02670525|Genetic|Leukemia Profiling|Genetic profiling of leukemia cells will be performed and analyzed by an expert panel. Matched targeted therapy recommendation based on profiling results will be made if available. The recommendation, if available, will be communicated to the primary oncologist.
16029407|NCT02670512|Device|Telehome Monitoring|
16029408|NCT02670499|Device|CPM|Used to aid in recovery from TKR
16029409|NCT02670499|Device|GAPFLEX|Used to aid in the recovery of TKR
16029410|NCT02670486|Other|Audiovisual stimulus|Water fountain and a video (including scenes of some common triggers for OAB) played on continuous loop throughout the test on a laptop
16029533|NCT02669524|Drug|LY2409021|
16029412|NCT02670460|Device|LIVE Catheter|Placement of a temporary LIVE Catheter central venous pacing device in the left subclavian vein to pace the phrenic nerves and allow recruitment of the diaphragm muscle.
16029413|NCT02670447|Procedure|MRI|Magnetic Resonance Imagery will be performed on patients attempted by schizophrenia. The aim of this intervention is an early detection of the non-answering patients to the primary cares.
16029414|NCT02670434|Drug|NK-104-CR|NK-104-CR 8 mg daily for 52 weeks
16029415|NCT02670434|Drug|Placebo|Placebo daily for 12 weeks
16029416|NCT02670434|Drug|Livalo|Livalo® IR daily from week 12 to week 52
16029417|NCT02670421|Behavioral|Face to Face Heart SMART Program|The Heart SMART stress management program survey consists of Perceived Stress Scale (PSS), Brief Resilience Scale (BRS), Patient Health Questionnaire (PHQ - 9) and Generalized Anxiety Disorder (GAD - 7), followed by email communication every three weeks.
16029418|NCT02670421|Behavioral|On-line Heart SMART Program|The Heart SMART stress management program survey consists of PSS (Perceived Stress Scale), BRS (Brief Resilience Scale), PHQ-9 (Patient Health Questionnaire) and GAD-7 (Generalized Anxiety Disorder) taken on-line in twelve, 10 minutes sessions.
16029419|NCT02670421|Behavioral|Mayo Clinic Guide to Stress Free Living|All subjects will be provided with a copy of the book entitled Mayo Clinic Guide to Stress Free Living and encouraged to read it over the twelve week study period.
16029421|NCT02670395|Drug|JNJ-54416076|JNJ-54416076 suspension will be administered orally.
16029422|NCT02670395|Drug|Placebo|Placebo solution will be administered orally.
16029423|NCT02670382|Dietary Supplement|EPA|10 week supplementation
16029424|NCT02670382|Dietary Supplement|DHA|10 week supplementation
16029425|NCT02670382|Dietary Supplement|sunflower oil|4-week lead-in
16029426|NCT02670369|Behavioral|Sitting time prompt|Participants will receive a device that prompts them to take breaks from sitting approximately every 15-20 minutes.
16029427|NCT02670356|Dietary Supplement|Fish oil|two 750 mg/capsules/day
16029428|NCT02670356|Dietary Supplement|Krill oil|one 300 mg capsule/day
16029429|NCT02670343|Drug|Oral Testosterone Undecanoate|Subjects will receive a single dose containing 158 mg of testosterone undecanoate, equivalent to 200 mg testosterone.
16029430|NCT02670330|Drug|SD-101-6.0 cream|SD-101 is a white, crystalline powder that is formulated within an odorless, soft, white cream base. SD-101-6.0 cream contains allantoin, a diureide glyoxylic acid, at a concentration of 6% and other excipients.
16029431|NCT02670317|Drug|Obinutuzumab|Patients will receive a maximum of 6 courses of G-CHOP-21 followed by 2 doses of Obinutuzumab in combination with Ibrutinib.
16029432|NCT02670317|Drug|Ibrutinib|Patients will receive a maximum of 6 courses of G-CHOP-21 followed by 2 doses of Obinutuzumab in combination with Ibrutinib.
16029433|NCT02670317|Drug|CHOP|Patients will receive a maximum of 6 courses of CHOP-21 in combination with Obinutuzumab (G) followed by 2 doses of Obinutuzumab in combination with Ibrutinib.
16029434|NCT02670304|Drug|letrozole|letrozole from the day of oocyte retrieval for 5 days
16029435|NCT02670304|Drug|Aspirin|aspirin from the day of oocyte retrieval for 5 days
16029436|NCT02670291|Device|MagPro Cool-B65A/P, Magventure|combined active and sham coil
16029437|NCT02670291|Device|MagPro Cool-B65A/P, Magventure|combined active and sham coil
16029438|NCT02670265|Dietary Supplement|Olimel Peri 2.5% ®|During hospital stay patients received 1 l Olimel peri 2.5 %® containing 700 kcal (25.3 g protein, 30.0 g fat and 75.0 g glucose) daily by intravenous route.
16029439|NCT02670265|Dietary Supplement|Isotonic fluid (E153)|Controls received 1l of isotonic fluid daily by intravenous route.
16029440|NCT02670252|Drug|Busulfan (BU)|Busulfan was administered at 3.2 mg/kg/day on days -7 to -4.
16029441|NCT02670252|Drug|Cyclophosphamide (CY)|Cyclophosphamide was administered at 60 mg/kg/day on days -3 to -2.
16029442|NCT02670252|Radiation|Total Body Irradiation (TBI)|Total Body Irradiation was given 4.5 Gy TBI/day on days -5 and -4.
16029443|NCT02670239|Procedure|normothermic ex vivo lung perfusion|
16029444|NCT02670226|Other|Samples|Blood samples, muscle biopsy
16029445|NCT02670213|Drug|recombinant factor XIII|No treatment given.Patients will be treated according to routine clinical practice at the discretion of the treating physician.
16029446|NCT02670200|Behavioral|cognitive behavior therapy|treatment technique to help people to overcome psychological distress and mental diseases
16029447|NCT02670187|Biological|GLS-5300|
16029448|NCT02670174|Other|Traditional training|
16029449|NCT02670174|Other|Separate kinetic chain training|
16029450|NCT02670174|Other|Integrated kinetic chain training|
16029451|NCT02670161|Drug|Listed for each disorder below, up to three drugs per disorder (too many characters to list in this field; see Intervention Description)|brain tumors (lamotrigine, levetiracetam, valproic acid), epilepsy (lamotrigine, levetiracetam, valproic acid), mild cognitive impairment (donepezil, rivastigmine, memantine), migraine (amitriptyline, propranolol, topiramate), migraine (sumatriptan, rizatriptan, zolmitriptan), mild traumatic brain injury (omega-3 fatty acids, education only), multiple sclerosis (ACTH, methylprednisolone), neuropathy (duloxetine, pregabalin, amitryptiline), Parkinson's disease (pramipexole, ropinerole, rotigotine), restless legs syndrome (pramipexole, ropinerole, rotigotine), stroke (aspirin, clopidogrel).
16029452|NCT02670148|Procedure|Chiropractic manipulative therapy|We will set an a priori treatment schedule of 8 visits at a frequency of 2 visits per week over a 4 week period. CC participants will receive chiropractic manipulative therapy (CMT). CMT procedures can be broadly divided into two types, thrust and non-thrust. Thrust CMT is a high-velocity low-amplitude procedure characterized by a single, short duration thrust (ranging from 100 to 500 ms) of low amplitude force applied to a target joint that often results in an audible sound, or cavitation. Non-thrust CMT employs low-velocity and often repeated joint movements of varying amplitude. In the event that no CMT treatment is clinically indicated, treatment will not be provided.
16029453|NCT02670135|Drug|Triclosan Containing Toothpaste|Active formula containing 0.3% triclosan in a1450 ppm sodium fluoride/silica base
16029454|NCT02670135|Drug|Triclosan Free Toothpaste|Control toothpaste with no triclosan ingredients in a 1450 ppm sodium fluoride/silica base - matching placebo
16029534|NCT02669524|Drug|LY2409021 placebo|
16029455|NCT02670122|Device|DEB-TACE|Selective and ultraselective transcatheter intraarterial administration up to 3ml of well calibrated 100µ drug eluting microspheres with up to 150 mg of doxorubicin.
16029456|NCT02670109|Drug|Carmustine|300mg/m2, IV, in 3 hours, during day -4
16029457|NCT02670109|Drug|Cyclophosphamide|80mg/kg, IV, in 2 hours, during two days -2, -3
16029458|NCT02670109|Drug|Carboplatin|1400/m2, IV, in 1 hour, during day -3
16029459|NCT02670109|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Transfusion, in 3 hours, during day 0
16029460|NCT02670109|Drug|Busulfan|16mg/kg, Oral, during day -4
16029461|NCT02670096|Drug|Acetazolamide|Two single dose administrations of acetazolamide (once before daytime testing, and once before nighttime testing)
16029462|NCT02670083|Drug|Crenezumab|Crenezumab was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.
16029463|NCT02670083|Drug|Placebo|Placebo was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.
16029464|NCT02670070|Drug|gemigliptin 50mg, rosuvastatin 20mg|gemigliptin/rosuvastatin 50/20mg
16029465|NCT02670057|Procedure|Transnasal SPG block|
16029466|NCT02670044|Drug|Cobimetinib|Cobimetinib will be administered orally as per schedule in Arm description.
16029467|NCT02670044|Drug|Idasanutlin|Idasanutlin will be administered orally as per schedule in Arm description.
16029468|NCT02670044|Drug|Venetoclax|Venetoclax will be administered orally as per schedule in Arm description.
16029469|NCT02670031|Other|Cardiovascular Magnetic Resonance|For the evaluation of left ventricular volumes, function and mass. This is also for the assessment of myocardial fibrosis based on delayed enhancement imaging technique.
16029470|NCT02670031|Other|Echocardiogram|For the assessment of diastolic and systolic function as well as valvular and cardiac function. Ventricular-arterial coupling will also be performed.
16029471|NCT02670031|Other|Electrocardiogram|To examine specific function of the heart.
16029472|NCT02670031|Device|Ambulatory Blood Pressure Monitoring|A 24-hour test.
16029473|NCT02670031|Other|Retinal Photography (Optional)|The test studies the structure and function of the eye vessels. It involves using eye drops to dilate the pupils, allowing the retinal photographer to have a better view of the back of the eye.
16029474|NCT02670018|Drug|gemigliptin and metformin HCl extended release|Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg * 2 tablets, for 1 day
16029475|NCT02670018|Drug|gemigliptin/metformin HCl extended release|Administration of combination of gemigliptin 25mg/metformin HCl extended release 1000mg * 2 tablets, for 1day
16029476|NCT02669992|Procedure|Stapled or Hand-sewn anastomosis|Randomization between stapled or hand-sewn anastomosis
16029477|NCT02669992|Procedure|Mesh or suture stoma site closure|Randomization between suture or Mesh closure of the stoma site
16029478|NCT02669979|Other|Intervention|Professional oral care
16029479|NCT02669966|Procedure|Kidney transplantation|Once the donor and recipient candidates have met inclusion criteria and cleared study-specific as well as standard of care screening, they will proceed to live-donor kidney transplantation and subsequent post-transplant monitoring
16029480|NCT02669953|Drug|Aflibercept|
16029481|NCT02669927|Other|Observational|
16029482|NCT02669914|Drug|MEDI4736|
16029483|NCT02669901|Behavioral|Naloxone Auto-Injector|Naloxone auto-injector is the only product FDA approved and labeled for use by family members or caregivers for emergency therapy and rescue wherever opioids are present. Bystanders of patient are able to provide naloxone when drug overdose occurs.
16029484|NCT02669888|Drug|Indigo naturalis ointment|Every 10 x 10 cm area of lesion requires 0.5 g of ointment, applied twice daily (morning and evening, separated by approximately 12±2 hours) for 6 weeks.
16029485|NCT02669888|Drug|Placebo|Every 10 x 10 cm area of lesion requires 0.5 g of ointment, applied twice daily (morning and evening, separated by approximately 12±2 hours) for 6 weeks.
16029486|NCT02669875|Drug|Serelaxin|Serelaxin solution diluted in 5% glucose volume/volume (v/v) solution
16029487|NCT02669875|Drug|Placebo|Placebo solution (20mM sodium acetate pH5) diluted in 5% v/v glucose solution
16029488|NCT02669862|Drug|A-101 Solution 40|
16029489|NCT02669862|Drug|A-101 Solution 45|
16029490|NCT02669862|Drug|Vehicle Solution|
16029491|NCT02669849|Drug|VX-210|
16029492|NCT02669849|Drug|Placebo|
16029493|NCT02669836|Procedure|Posterior fossa decompression|Planned areas of bone removal from the suboccipital region of the skull and cervical l1 lamina. Then, the constricting epidural band at the level of the foramen magnum is resected.
16029494|NCT02669836|Procedure|Dural Augmentation|The dura is opened sharply, exposing the cerebellar tonsils, brainstem, and upper spinal cord. After microsurgical dissection, the dura is sewn closed with a dural graft.
16029495|NCT02669823|Other|None, treatment as actual best practice|
16029496|NCT02669810|Drug|PROTHERACYTES|"ProtheraCytes endocardiac injections performed with:
~the HELIX and Morph catheters (if no Intra Ventricular Thrombus)
~the BullFrog catheter (if Intra Ventricular Thrombus)"
16029497|NCT02669810|Drug|Standard Treatment for CHF post AMI|
16029498|NCT02669797|Behavioral|In-home Visits and Food Preparation Activities|"Families will participate in twelve in-home education activities. The visits will focus on family meal quality (dietary, interpersonal) and quantity (meal frequency) factors found in prior studies to be associated with child weight and weight-related behaviors. Eight of the visits (every other week) will be delivered by a CHW and will last 90 minutes. Additionally ,a family meal food preparation activity will occur to help support families in learning skills to increase family meal quality and quantity. On weeks opposite of the in-home education visits with a CHW, families will be given a Try it Yourself activity to reinforce the messages (e.g., use family meals as a family connection time) and skills (e.g., recipe that requires families to steam vegetables) taught by the CHW during the in-home education visits."
16029535|NCT02669524|Procedure|OGTT|
16029536|NCT02669524|Procedure|IIGI|
16029537|NCT02669524|Procedure|Standardised liquid meal|
16029538|NCT02669511|Drug|PQR309|Oral PQR309, 80mg or 60mg daily or intermittent dosing
16029539|NCT02669498|Procedure|Routine fallopian tube removal|Fallopian tubes are removed by dissection of the Mesosalpinx.
16029619|NCT02668874|Device|Cotton Roll technique|A cotton roll is placed between the cheek and tongue prior to sealant application
16029499|NCT02669797|Behavioral|Ecological Momentary Intervention|Parents will receive daily EMI messages regarding suggestions for increasing meal quality/quantity via a smartphone application, based on the stress level and source of stress they reported earlier in the day. Specifically, parents will receive two push notifications in the morning to report their stress level and type/source of stress (e.g., work, children, finances). Then, based on the reported stress level and source of stress, parents will be texted tips/ideas for carrying out a nutritionally and emotionally healthful family meal the same night, in the face of stress. If parents report no stress on their EMI measure earlier in the day, they will be provided with a menu of options regarding what type of meal tip they would prefer later in the day (e.g., recipe ideas, meal prep tips, mealtime conversation starters. Parents will be able to respond to the EMI messages indicating preferred tips so that EMI tips become more meaningful/relevant to the needs of each family.
16029500|NCT02669797|Behavioral|Feedback on Video-recorded Family Meals|Parents will video-record and upload via an iPad (study provided) one family meal every other week, which will be watched by intervention staff. Using Motivational Interviewing, CHWs will give specific feedback on how to adapt negative mealtime behaviors and provide reinforcement for positive behaviors seen in the videos, based on a validated interpersonal coding tool called the Iowa Family Interaction Rating Scales (IFIRS). Additionally, feedback will be given on the dietary healthfulness of the meal, based on a validated coding tool called the Healthfulness of Meal Index (HOM). After feedback, family members will be taught specific skills to improve their family meal processes and behaviors that vary from food preparation skills, to increasing healthful food options at meals, or role-playing family interactions to improve the emotional atmosphere at the meal. Families will also set SMART goals at each visit regarding family meal quality and quantity.
16029501|NCT02669797|Behavioral|Maintenance|After 16 weeks, EMI family meal tips for all arms will be reduced to only the days in which parent's report their highest stress levels. Stress profiles will be created for each parent in order to tailor the EMI family meals tips to days in which they experience their highest levels of stress. For example, during the 16-weeks of EMI, a parent may report their highest stress levels on Tuesdays and Thursdays. The stress profile that would be created for the parent during the maintenance phase would include receiving text messages only on Tuesdays and Thursdays. The parent would then receive these EMI family meal tips only on Tuesdays and Thursdays throughout the 8-week maintenance phase..
16029502|NCT02669784|Drug|Low Dose Contrast (Omnipaque) 40mL|The patient will be administered a low dose, 40mL of intravenous contrast (Omnipaque) at a rate of 5mL/sec based on the area of the body being scanned (chest versus chest and abdomen versus chest, abdomen and pelvis). This will be compared to the patient's prior examination performed with 100mL of intravenous contrast at a rate of 4mL/sec.
16029503|NCT02669784|Drug|Low Dose Contrast (Omnipaque) 50 mL|The patient will be administered a low dose, 50mL of intravenous contrast (Omnipaque) at a rate of 5mL/sec based on the area of the body being scanned (chest versus chest and abdomen versus chest, abdomen and pelvis). This will be compared to the patient's prior examination performed with 100mL of intravenous contrast at a rate of 4mL/sec.
16029504|NCT02669771|Drug|enzalutamide|oral
16029505|NCT02669758|Drug|ALKS 3831|Tablets were administered for daily dosing
16029506|NCT02669732|Drug|DS-8500a|tablets
16029507|NCT02669732|Drug|placebo|tablets
16029508|NCT02669719|Biological|chemotherapy followed dendritic cells|Pemetrexed and carboplatin would be administered on day 1 of each 3-week cycle.Patients will start with dendritic cells treatment on Day 15 of pemetrexed and carboplatin chemotherapy from Cycle 3 provided that both leukapheresis and the production of dendritic cells are successful.
16029509|NCT02669719|Drug|pemetrexed and carboplatin|Chemotherapy with 4-6 cycles of pemetrexed and carboplatin as first-line induction chemotherapy followed by pemetrexed as maintenance therapy.
16029510|NCT02669706|Drug|Pentamidine|Pentamidine is an antimicrobial medication given for prevention and treatment of Pneumocystis pneumonia (PJP) caused by Pneumocystis jirovecii
16029511|NCT02669693|Dietary Supplement|bread without olives|
16029512|NCT02669693|Dietary Supplement|bread with olives|
16029513|NCT02669680|Drug|G-CSF|G-CSF subcutaneously, 5 μg/kg daily on day 0-4, then every 3rd day over 26 days (days 7, 10, 13, 16, 19, 22, 25) = 12 doses
16029514|NCT02669680|Other|Standard therapy|
16029515|NCT02669667|Drug|MEDI9314|single dose of MEDI9314
16029516|NCT02669667|Drug|placebo|single dose of placebo
16029517|NCT02669654|Other|Day-care management of Severe Pneumonia|Day-care management of Severe Pneumonia
16029518|NCT02669641|Dietary Supplement|Combination Silimarin, Phyllanthus niruri and Choline|Combination of one capsule: Phyllanthus niruri (225 mg), Silybum marianum (150 mg), Choline (60 mg) The dose: 3 capsules per day.
16029519|NCT02669628|Procedure|Surgical technique|Laparoscopic surgery
16029520|NCT02669628|Procedure|Alcohol sclerotherapy|US-guided sclerotherapy
16029521|NCT02669615|Drug|Melphalan HCl for injection (propylene glycol free)|During the study period, patients will receive 200 mg/m^2 of Melphalan HCl for injection (propylene glycol free) as a one-time infusion on day 2.
16029522|NCT02669589|Drug|Heparin|
16029523|NCT02669589|Drug|Citrate|
16029524|NCT02669576|Behavioral|Mind body medicine day care clinic|Patients recieve an 11-week mind body day care clinic including elements of mindfullness based stress reduction (MBSR), yoga, acupuncture, education
16029525|NCT02669576|Other|Usual care|Patients continue usual care by their practitioner
16029526|NCT02669563|Drug|[18F]4F-MHPG|IV injection of [18F]4F-MHPG
16029527|NCT02669563|Drug|[18F]3F-PHPG|IV injection of [18F]3F-PHPG
16029528|NCT02669563|Drug|[13N]ammonia|IV injection of [13N]ammonia
16029529|NCT02669563|Drug|[11C]HED|IV injection of [11C]HED
16029530|NCT02669550|Device|Fiberoptic bronchoscope|In case of FOB, the FOB was inserted into oral cavity, and the epiglottis and glottis were identified by the FOB. The anterior of FOB was inserted deep into tracheal after the glottis was exposed sufficiently then the tracheal tube was pushed into the trachea via the FOB
16029531|NCT02669550|Device|Disposcope endoscope|In the DE group, the operator gripped the chin and lower incisors of patients with the fingers and thumb to open the mouth adequately wide and grasped the wire body, which was enclosed within the endotracheal tube, by the other hand and held it parallel to,then inserted into oral cavity
16029532|NCT02669537|Device|GoPro Camera|The gopro camera will be used to record the procedure which will be reviewed by the resident prior to performing a second procedure of the same type.
16029540|NCT02669485|Drug|indocyanine green|Injection of indocyanine green and using fluorescence imaging to assess perfusion of bowel before bowel transection and anastomosis
16029541|NCT02669485|Device|Fluorescence imaging|
16029542|NCT02669472|Other|Environmental Intervention|Intervention sites received regularly-scheduled, discount, fresh F&V markets for one year during the first two weeks of each month. The markets brought between 50-70 different produce items, including culturally desired ethnic produce. Markets at the senior and disabled housing complexes were held indoors as were markets at family housing complexes during inclement weather. In good weather, markets were held outside at the family complexes using a mobile retrofitted car trailer. The produce items were set up in racks on three sides of the trailer and shoppers entered through the rear door. FTY markets accepted cash, debit/credit cards and EBT cards (SNAP). Each market lasted two hours and the produce was sold at prices 15%-25% lower than local retail supermarket prices.
16029543|NCT02669472|Behavioral|Educational Intervention|Each household in the housing site received a reusable shopping bag that contained a binder with: an overview page, sleeves to store 12 newsletters, three DVDs and 48 recipe cards. The 20-minute DVDs included cooking demonstrations, tips and testimonials. A two-page, full-color newsletter was delivered each household each month. It had information about a particular F&V in season as well as other tips and recipes. Two 6-week long educational and motivational campaigns were also offered: ''Just Add 2', and 'Color Your Plate'. Both campaigns included full-color campaign booklets, goal-setting activities, educational and motivational content, and F&V trackers with incentives/prizes for completing and turning in the trackers. All materials were provided in English and Spanish.
16029544|NCT02669472|Behavioral|Control|We contracted with the Greater Providence YMCA to bring to provide physical activity and stress reduction programming. Two, six-week campaigns followed the same format and timing of the intervention group campaigns. Campaigns participants received a free, 6-week membership to the YMCA. The 'Take 10!' campaign aimed to increase participants' daily physical activity by 10 minutes per day until they reached the goal of at least 30-60 minutes per day. The second campaign was 'Stress Less' aimed to help participants reduce the amount of stress that they experienced by including relaxation activity into their daily routine.
16029545|NCT02669459|Drug|Imiquimod|12,5 mg imiquimod three times per week during 16 weeks
16029546|NCT02669459|Procedure|LLETZ|surgical treatment for CIN, current gold standard
16029547|NCT02669446|Device|Medical devices|
16029548|NCT02669446|Device|traditional household remedy|
16029549|NCT02669433|Drug|RVT-101 35 mg|once daily, oral, 35-mg tablets
16029550|NCT02669433|Drug|RVT-101 70 mg|once daily, oral, 35-mg tablets
16029551|NCT02669433|Drug|Placebo|once daily, oral, matching tablets
16029552|NCT02669420|Procedure|termination of second trimester pregnancy|Intra uterine extra amniotic (200 μg ) versus Vaginal (200 μg) Misoprostol for Second Trimester Pregnancy Termination. Randomized controlled trial
16029553|NCT02669407|Procedure|splanchnic nerve anesthesia with a local anesthetic|regional nerve block of the splanchnic nerve
16029554|NCT02669407|Drug|regional nerve block with a local anesthetic (Lidocaine)|
16029555|NCT02669394|Behavioral|Resistance exercise training|Twelve months of twice-weekly resistance training program that will gradually progress in intensity. Each training session will be 60 minutes (10 minutes of warm-up, 40 minutes of training, and 10 minutes of cool-down).
16029556|NCT02669394|Behavioral|Control: stretching and relaxation program|Twelve months of twice-weekly stretching and relaxation program that includes stretches, deep breathing and relaxation techniques, general core control exercises, and general posture and health education. Each session will be 60 minutes.
16029557|NCT02669381|Dietary Supplement|Phenylalanine intake|Oral consumption of eight hourly experimental meals- Includes 4 tracer-free experimental meals containing a mixture of free amino acids, calories from a flavored liquid and protein free cookies and 4- labeled amino acid experimental meals.
16029558|NCT02669368|Drug|Magnesium Sulfate|Patients in each group receive Magnesium sulfate 30 mg/kg in 0.9% normal saline (total volume 100 ml) intravenously for 5 min before induction of anesthesia
16029559|NCT02669368|Drug|Saline|Patients in each group receive 0.9% normal saline (total volume 100 ml) alone intravenously for 5 min before induction of anesthesia
16029560|NCT02669368|Drug|Standard dose Rocuronium|0.6 mg/kg of Rocuronium given with induction of anesthesia
16029561|NCT02669368|Drug|Low dose Rocuronium|0.45 mg/kg of Rocuronium given with induction of anesthesia
16029562|NCT02669342|Device|Radiance™ Clear Sharklet® Silicone Foley Catheter|
16029563|NCT02669342|Device|Silicone Foley Catheter|
16029564|NCT02669329|Device|CoolSculpting device with vacuum applicator.|The CoolSculpting device with a vacuum applicator will be used to perform the treatments.
16029565|NCT02669303|Drug|platelet-rich plasma group|"Once randomized to platelet-rich plasma arm, the study subject will have 30cc of blood drawn and centrifuged using the Recover(TM) Platelet Separation Kit (Biomet Biologics, Warsaw, Indiana, USA). The extracted platelet-rich plasma part will be re-injected into the subacromial space of the subject's affected shoulder."
16029566|NCT02669303|Drug|Methylprednisolone group|Once randomized to Methylprednisolone arm, the study subject will have an injection with 2ml of Methylprednisolone (40mg/ml methylprednisolone acetate injectable suspension) (Pharmacia Upjohn, Kalamazoo, Michigan, USA) with 2ml of lidocaine hydrochloride 2% (Hameln Pharmaceuticals Ltd, Gloucester, UK) into the subacromial space of their affected shoulder.
16029567|NCT02669290|Other|Guided|LV lead placement will be guided by left ventricular systolic function information from MUGA
16029568|NCT02669290|Other|Non-guided|LV lead placement will be conventional posterolateral placement
16029569|NCT02669277|Drug|IVIG prepared by minipool technology|Drug: To demonstrate the efficacy of new product IVIG prepared by minipool technology as assessed by Bleeding Score and platelet count at 3 days, 1 week, 2 weeks and 4 weeks.
16029570|NCT02669277|Drug|standard IVIG product|to compare efficacy and safety with the minipool IVIG
16029571|NCT02669264|Drug|ADCT-402|Intravenous infusion
16029573|NCT02669238|Device|Nexplanon®|Subcutaneous implant (Nexplanon®) containing etonogestrel 68 mg
16029618|NCT02668874|Device|Isolite® technique|The Isolite technique utilizes a flexible plastic dental adapter to separate the cheek and tongue prior to sealant application.
16029574|NCT02669238|Drug|Minidril®/Leeloo®|continuous per os administration of oestroprogestative treatment. 1 pill a day First line: Minidril® (Levonogestrel 0.15 mg / Ethinylestradiol 0.03 mg) Second line: Leeloo® (Levonogestrel 0.1 mg / Ethinylestradiol 0.02 mg)
16029578|NCT02669199|Biological|MSCs|The main purpose of this test is to assess the umbilical cord MSCs between source sample sweat gland cells wound transplanted effectiveness and safety for the treatment of large area skin lesions of the subjects
16029579|NCT02669186|Drug|Bupivacaine + Fentanyl|General endotracheal anesthesia augmented with an epidural. The epidural solution intraoperatively and post-operatively will contain fentanyl + bupivacaine titrated to appropriate surgical conditions and post-operative pain control.
16029580|NCT02669186|Drug|Bupivacaine|General endotracheal anesthesia augmented with an epidural. The epidural solution intraoperatively and post-operatively will contain bupivacaine titrated to appropriate surgical conditions and post-operative pain control
16029581|NCT02669173|Drug|Capecitabine|Drug given orally. Dose to be determined by phase 1 dose escalation, cycle length 28 days. Treatment until progression
16029582|NCT02669173|Drug|Bevacizumab|Drug given by IV, 10 mg/kg days 1, 15 every 28 days, until progression.
16029583|NCT02669160|Device|PC Innowalk|
16029584|NCT02669160|Device|Conventional passive stander|
16029585|NCT02669134|Other|Device programming|"SonRtip bipolar atrial lead and LivaNova (Sorin) CRT-D implantation with device programming: SonR CRT Optimization programmed AV+VV"
16029586|NCT02669121|Biological|NoV Placebo-matching Saline|NoV placebo-matching saline (0.9% sodium chloride).
16029587|NCT02669121|Biological|NoV GI.1/GII.4 Bivalent VLP Vaccine|NoV bivalent VLP vaccine, adjuvanted with 500 µg aluminum as Al(OH)3.
16029588|NCT02669108|Device|PET/ MRI of the Testis|PET/MRI of the testis will be performed upon the patient achieving azoospermia (following the vasectomy), or 25 ejaculations and following proven azoospermia (via standard of care semen analysis).
16029589|NCT02669095|Device|Investigational Contact Lenses (Test)|
16029590|NCT02669095|Device|Marketed Contact Lenses (Control)|
16029591|NCT02669082|Drug|Ramelteon|Ramelteon tablets
16029592|NCT02669069|Device|PS1|Participants in this arm shall be given an audio stimulus which comprises of a sequence of tones, mixed with a broadband noise that is spectrally modified to compensate for any hearing loss. Electrical pulses in the somatosensory stimulation are synchronous with the tones.
16029593|NCT02669069|Device|PS2|Participants in this arm shall be given an audio stimulus which comprises of a sequence of tones, mixed with a broadband noise that is spectrally modified to compensate for any hearing loss. Electrical pulses in the somatosensory stimulation are uncorrelated and asynchronous with the tones.
16029594|NCT02669069|Device|PS3|Participants in this arm shall be given an audio stimulus which comprises of a sequence of single-frequency tones mixed with a broadband noise with the frequency characteristics of both chosen outside the region of any hearing loss. Electrical pulses in the somatosensory stimulation are uncorrelated and asynchronous with the tones.
16029595|NCT02669056|Other|5-HT measurement|
16029596|NCT02669056|Other|cerebral MRI|
16029597|NCT02669056|Other|Video recording|
16029598|NCT02669056|Other|EEG|
16029599|NCT02669056|Other|growth curves|
16029600|NCT02669056|Other|ASQ questionnaire|
16029601|NCT02669043|Drug|Ketamine|Intravenous ketamine 0.5mg/kg over 40 minutes
16029602|NCT02669030|Drug|suvorexant|an FDA-approved sleep aid
16029603|NCT02669030|Drug|Placebo|control group
16029604|NCT02669017|Drug|ADCT-402|intravenous infusion
16029605|NCT02669004|Drug|Intermittent bolus epidural morphine|morphine given with patient- controlled intermittent bolus epidural, 50 µg/kg in 10 mL bolus, lockout time 1 hour, no infusion
16029606|NCT02669004|Drug|continuous epidural morphine|morphine given with patient- controlled continuous epidural, initial setting loading morphine 0.02mg/kg in 8mL, was maintained 0.01 mg/kg continuous infusion 4mL, 0.05 mg/kg 2mL bolus dose. 30 minute lock-out interval. 4 hour limit was 4 mg/kg.
16029607|NCT02668978|Device|Hemopatch™ Sealing Hemostat|Hemopatch™ application over lung resection areas
16029608|NCT02668978|Procedure|Standard surgical technique|Lung resuturing or restapling
16029609|NCT02668965|Procedure|Intrauterine hCG (pregnyl)|
16029610|NCT02668952|Drug|0.9% Normal Saline (0.9% Sodium Chloride) injection|
16029611|NCT02668952|Drug|Isolyte S injection|
16029612|NCT02668926|Drug|Lisdexamfetamine, d-amphetamine, Placebo|Elvanse (Lisdexamfetamine): 100mg p.o, single dose; d-Amphetamine: 40.3mg p.o, single dose; Placebo: Capsules containing mannitol looking identical to lisdexamphetamine and d-Amphetamine.
16029613|NCT02668926|Drug|d-amphetamine, Placebo, Lisdexamfetamine|Elvanse (Lisdexamfetamine): 100mg p.o, single dose; d-Amphetamine: 40.3mg p.o, single dose; Placebo: Capsules containing mannitol looking identical to lisdexamphetamine and d-Amphetamine.
16029614|NCT02668926|Drug|Placebo, Lisdexamfetamine, d-amphetamine|Elvanse (Lisdexamfetamine): 100mg p.o, single dose; d-Amphetamine: 40.3mg p.o, single dose; Placebo: Capsules containing mannitol looking identical to lisdexamphetamine and d-Amphetamine.
16029615|NCT02668913|Other|Diagnostic analysis|Molecular profiling
16029616|NCT02668900|Behavioral|Decision Support|The decision support intervention includes a patient decision and a decision coaching session. The patient decision aid includes a summary about the ICD's function, and the risks and benefits (including probabilities) associated with the option of replacing or not replacing the ICD. The decision coaching session will be led by a trained, non-directive decision coach who will provide support that aims to develop patients' skills in thinking about the options, assess their values associated with each option, and prepare them to discuss the decision in a consultation with their physician. The final decision, whether to replace or not replace the ICD, will be made with their treating physician (e.g., cardiologist, electrophysiologist).
16029617|NCT02668887|Behavioral|Quality of Life, status of employment|
16029621|NCT02668861|Drug|Budesonide Nasal Spray|Budesonide Nasal Spray 128ug/d for 8 week
16029622|NCT02668861|Other|placebo|placebo for 8 weeks
16029623|NCT02668848|Dietary Supplement|water|If USG>1.02, patients will be advised to drink water via oral or tubal feeding with a dose of 5cc/kg body weight , maximum 300cc, and repeat the same amount of water after dinner in the same day.
16029624|NCT02668835|Device|Non intervention-Monitoring device|Fox Insight self-monitoring android app and smartwatch Participants will be asked to wear a smartwatch with accelerometers, during day and night, for a period of 2 weeks. Additionally, a self-monitoring app on a smartphone is used, where the participant reports when they take any medication and performs a focused attention task to encourage resting tremor.
16029625|NCT02668835|Genetic|Non intervention-Genetic testing|
16029626|NCT02668822|Drug|ENG 125 μg + E2 300 μg vaginal ring (MK-8342B)|Medicated vaginal ring
16029627|NCT02668822|Drug|Placebo vaginal ring|Placebo vaginal ring
16029628|NCT02668822|Drug|Ibuprofen|Ibuprofen 400-mg tablets, to be taken orally, were provided to the participants for use as rescue medication for dysmenorrhea treatment throughout the study. Participants may have taken 400 mg every 4 hours as needed for pelvic pain/cramping.
16029629|NCT02668809|Other|oral health assessment|A baseline oral health assessment of both residents and direct care workers will be conducted before interventions are initiated. Data will be entered directly into a spreadsheet format using the chairside software program to be developed as part of this proposal.
16029630|NCT02668809|Other|Questionnaires|Age, sex, race, nutrition (mini-nutri), quality of life (SF-36), OHIP-14, GOHAI, sources of payment for the NF residency, comorbid conditions (e.g., constipation, arthritis), weight, medications, cognitive status (mini-mental) , dry mouth sensation, x-ray documented pneumonia;
16029631|NCT02668809|Other|Clinical Exam|Dentate status, dental/denture plaque index, DMFS (including root surfaces), gingival bleeding index, plaque index, presence of oral lesions, verification of mouth dryness;
16029632|NCT02668809|Other|Microbiological sampling|Samples will be collected by swabbing patients intra-oral tissues. Samples will be separately collected from dentures and oral tissues for edentulous patients, also using swabs. All samples will be suspended in saline solution.
16029633|NCT02668809|Other|Monitoring Adherence|Adherence to the protocol will be evaluated through unannounced observations at the NF by study personnel twice per month. Adherence is determined by direct observation of the DCW administering the intervention.
16029634|NCT02668809|Other|Varnish application|"1% chlorhexidine varnish application group will receive the educational program described above. In addition, residents who need supervision or are unable to perform oral hygiene procedures will receive 1% chlorhexidine varnish application monthly by the dental hygienist. No additional time commitment will be necessary.The direct care workers will NOT receive any varnish."
16029635|NCT02668809|Other|Consent|Both the residents and primary care workers will be asked to participate on the study, and the investigators will provide information and collect signed informed consents primarily during two in person visits to each nursing facilities.
16029636|NCT02668809|Other|Educational Program|Cognitively capable residents will receive instruction on how to perform their own oral hygiene accordingly to their own needs; and 2) Direct care workers will receive instruction on how to perform oral hygiene for dependent residents or supervise the oral hygiene routines of independent patients. For both 1) and 2) above, dental hygienists will provide a short, standardized presentation and hands-on demonstration.
16029637|NCT02668796|Drug|Estradiol Vaginal Tablets 10 mcg (Glenmark)|apply using the given applicator
16029638|NCT02668796|Drug|Vagifem® (Estradiol Vaginal Tablets) 10 mcg (Novo Nordisk)|apply using the given applicator
16029639|NCT02668796|Drug|Placebo of Estradiol Vaginal Tablets 10 mcg (Glenmark)|apply using the given applicator
16029640|NCT02668783|Drug|Etonogestrel (ENG) 125 μg + 17β-estradiol (E2) 300 μg vaginal ring|Up to 4 cycles (or 6 cycles if also participating in the extension) of ENG-E2 125 μg/300 μg administered intravaginally. Each cycle will consist of 21 days of vaginal ring use followed by 7 ring-free days.
16029641|NCT02668783|Drug|Placebo vaginal ring|Up to 4 cycles (or 6 cycles if also participating in the extension) of placebo administered intravaginally. Each cycle will consist of 21 days of placebo vaginal ring use followed by 7 ring-free days.
16029642|NCT02668783|Drug|Ibuprofen|Ibuprofen tablets, to be taken orally, will be provided for use as rescue medication for dysmenorrhea treatment throughout the study. Participants may take 400 mg every 4 hours as needed for pelvic pain/cramping, or as instructed by their physician according to local labeling for relief of menstrual pain.
16029643|NCT02668770|Drug|MGN1703|"Dose Escalation Group Starting Dose: 15 mg on Days 1, 8, and 15 of each 21 day cycle.
~Dose Expansion Group Starting Dose: Maximum tolerated dose from Dose Escalation Group."
16029644|NCT02668770|Drug|Ipilimumab|Dose Escalation and Dose Expansion Group Dose: 3 mg/kg by vein on Day 8 of a 21 day cycle.
16029645|NCT02668757|Behavioral|HeartHab application intervention|The intervention patients will use the HeartHab application on a smartphone. During the study, the patients will use the HeartHab application for 4-6 weeks.
16029646|NCT02668744|Behavioral|Intervention|The intervention consists of building edible gardens at each the eight participating and eligible schools. Educators will be provided to lead 18 gardening, nutrition and cooking lessons throughout the school year intervention to all 3-5th grade students. Nine gardening, nutrition, and cooking classes will be taught to parents every month. Garden Leadership Coalitions (GLCs), made up of parents, teachers and school staff, will be formed and training/resources provided to help with adoption of the program. Training and resources will be provided to the GLCs and teachers in the 2nd year to assist with sustainability.
16029647|NCT02668718|Radiation|Adjuvant radiotherapy|The radiation therapy will be given in 37 fractions of 1.8 Gy per day, five days per week. The total dose of radiation will be 66.6 Gy.
16029648|NCT02668705|Other|Embodied Conversational Agent|A computer generated character that can administer informed consent to a potential research subject.
16029649|NCT02668692|Drug|LEO 80185 gel|calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions
16029650|NCT02668692|Drug|Dovobet ® ointment|calcipotriol hydrate 52.2 µg/g [equivalent to 50.0 µg/g calcipotriol] plus betamethasone dipropionate 0.643 mg/g, applied once daily to psoriasis lesions
16029685|NCT02668406|Other|Venous blood sampling (2 timepoints) (Phase A and B)|8.5ml at Day 1 + 8.5ml at Day 5
16029651|NCT02668679|Procedure|Sedation of children during gastroscopy with and without the presence of dream doctor|children and their parents with and without the presence of DD upon arrival to the Gastroenterology institute and throughout the induction of sedation, gastroscopy and recovery.
16029652|NCT02668679|Device|evaluation of stress with PPI and GSR|evaluation of stress in children undergoing gastroscopy with sedation with and without the presence of a dream doctor by measurement of PPI and GSR
16029653|NCT02668679|Biological|blood specimens for stress hormones|evaluation of stress in children undergoing gastroscopy with sedation with and without the presence of a dream doctor by measurement of stress hormones.
16029654|NCT02668679|Other|Physiological indices for evaluation of stress|evaluation of stress in children undergoing gastroscopy with sedation with and without the presence of a dream doctor by measurement of blood pressure, pulse, saturation and body temperature.
16029655|NCT02668666|Drug|Palbociclib|Palbociclib 125 mg will be administered orally once daily on days D1-D21 of each 28-day cycle. Subjects will not take palbociclib on D22-D28.
16029656|NCT02668666|Drug|Tamoxifen|Tamoxifen 20 mg will be administered orally once daily for every day of the 28-day cycle (i.e., continuously).
16029657|NCT02668653|Drug|Chemotherapy|
16029658|NCT02668653|Drug|Quizartinib|
16029659|NCT02668653|Drug|Placebo|
16029660|NCT02668640|Biological|Adalimumab|Pre-filled syringe, administered by subcutaneous injection
16029661|NCT02668627|Procedure|Endovascular treatment|Endovascular mechanical thrombectomy or endovascular delivery of thrombolytic agent
16029662|NCT02668614|Device|WR-22 model microwave sensor|
16029663|NCT02668588|Drug|extended release of octreotide|1 intramuscular injection of extended release of octreotide 30 mg
16029664|NCT02668588|Drug|extended release of placebo|1 intramuscular injection of extended release of placebo
16029665|NCT02668575|Behavioral|Supportive Care Intervention|Patients in the intervention arm of the study will see a SC specialist during regularly-scheduled CF clinic visits; per usual care, these visits should occur on a quarterly basis. Using a structured intervention manual, these visits will span 30-60 minutes each. Each visit will have a specific focus, such as: 1) comprehensive palliative care assessment; 2) symptom assessment and self-management; 3) advance care planning; and, 4) coping and resilience. Patients requiring follow up with SC before the next CF appointment will receive telephone follow up or an extra SC visit at the discretion of the SC provider.
16029666|NCT02668562|Procedure|Early CABG (Day 2-3 after ticagrelor discontinuation)|Timing for CABG after ticagrelor discontinuation
16029667|NCT02668562|Procedure|Delayed CABG (Day 5-7 after ticagrelor discontinuation)|Timing for CABG after ticagrelor discontinuation
16029668|NCT02668549|Other|DB review for Doctor/Pharmacy Shopping Behavior|Database review to evaluate of doctor/pharmacy shopping behaviors
16029669|NCT02668536|Drug|Standard Sunscreen|Areas will be treated with a standard preparation, consisting of padimate O (7%) and oxybenzone (3%) will be used as the control sunscreen.
16029670|NCT02668536|Device|BNP|Additional areas will be treated with empty bioadhesive nanoparticles (BNPs).
16029671|NCT02668523|Device|Raindrop Near Vision Inlay|To improve the near and intermediate vision in subjects who have previously undergone cataract surgery (pseudophakic subjects)
16029672|NCT02668510|Biological|platelet rich plasma|immediately following shockwave therapy the injection of PRP derived from subjects own blood using Arthex double syringe system will be injected at the origin of the plantar fascia at the calcaneous
16029673|NCT02668510|Drug|Normal saline|placebo injection of normal saline immediately following shockwave therapy
16029674|NCT02668497|Drug|Botulinum Toxin Type A|
16029675|NCT02668484|Device|repositionable valve prosthesis|repositionable valve prosthesis implanted via trans-femoral and trans-catheter route
16029676|NCT02668484|Device|balloon-expandable valve prosthesis|balloon-expandable valve prosthesis implanted via trans-femoral and trans-catheter route
16029677|NCT02668471|Procedure|Ultrasound|ultrasound at radial site and measure the size and depth of radial artery and perform radial artery cannulation
16029678|NCT02668471|Procedure|traditional method|Radial artery catheters will be placed by the palpation technique only.
16029679|NCT02668458|Procedure|High Flow nasal canula oxygen therapy|Pre-oxygenation with high-flow nasal canula oxygen therapy
16029680|NCT02668458|Procedure|Noninvasive ventilation|Pre-oxygenation with non-invasive ventilation
16029681|NCT02668445|Other|Standard meal containing low or high carbohydrate content|
16029682|NCT02668432|Drug|Amiodarone|Patients will receive a 150 mg IV bolus amiodarone dose, followed by a 1 mg/min continuous infusion for six hours, then 0.5 mg/min. Conversion to PO amiodarone will be based on patient hemodynamic stability and physician/pharmacist discretion. The total loading dose will be calculated based on all IV and PO amiodarone administered within 7 days from initiation of amiodarone. All doses will be compared in total PO equivalents (accounting for 50% bioavailability of PO vs IV amiodarone). Randomization may be overridden by the attending or fellow physician if the patient's severity of illness warrants. Discontinuation of amiodarone in the full-load group will be at the discretion of the physician/pharmacists, after the pre-determined randomization loading dose has been provided.
16029683|NCT02668419|Device|Neuromuscular Electrical Stimulator|"Quadriceps and calf muscles of both legs were simultaneously stimulated using self adhesive surface rectangular electrodes. During all session period, the patients were maintained in the supine Fowler 45º position. Stimulation parameters were set up as follows: biphasic current of 40 Hz, 400-µs pulse duration, mode on-time 10s and off-time 20s and maximal amplitude of 60 mA. The stimulation intensity was progressively increased according to the patient tolerance until a muscular contraction was observed. Stimulation was performed twice a day; the session duration was 60 min."
16029684|NCT02668419|Other|Physical Therapy Session|each session consisted of breathing exercises and global active exercises of the upper and lower limbs in bed. The treatment was applied twice a day during the hospitalization period. The protocol was interrupted if the patient had signs or symptoms suggestive of poor tolerance to exercise: 1) cyanosis, pallor, dizziness, nausea or pre-syncope; 2) chest pain; 3) bradycardia; 4) a drop in systolic blood pressure >15 mmHg in comparison to baseline; 5) an excessive rise in systolic blood pressure defined as >200 mmHg; 6) a rise in diastolic blood pressure during exercise >110 mmHg; 7) fatigue rated ≥6/10 on the perceived exertion Borg scale (PEB); and/or 8) electrocardiographic signs of cardiac ischemia or ventricular arrhythmias.
16029884|NCT02667054|Drug|Placebo|Placebo Comparator
16029686|NCT02668406|Other|Venous blood sampling (1 timepoint) (Phase A and B)|8.5ml at Day 1
16029687|NCT02668406|Other|Voided urine sampling (first sample) (Phase A)|At least 20ml upon confirmation of being part of one of the 3 study groups
16029688|NCT02668406|Other|Voided urine sampling (second sample) (Phase A)|At least 20ml during routine hospital stay or routine follow-up visit
16029689|NCT02668393|Drug|Docetaxel|
16029690|NCT02668393|Drug|Nintedanib|Low Dose
16029691|NCT02668393|Drug|Nintedanib|Medium dose
16029692|NCT02668393|Drug|Nintedanib|High dose
16029693|NCT02668393|Drug|Nintedanib|Continuous high dose
16029694|NCT02668367|Drug|BTA-C585 oral capsules|BTA-C585; Multiple ascending doses from 100 mg to 600 mg
16029695|NCT02668367|Drug|BTA-C585 matching placebo|Multiple ascending doses to match 100 mg to 600 mg BTA-C585 capsules
16029696|NCT02668341|Other|non-interventional|non-interventional survey study
16029697|NCT02668328|Behavioral|Social Cognitive Theory Tailored Behavioral Intervention|The intervention will enhance self-efficacy
16029698|NCT02668315|Biological|Transplantation of cord blood expanded with UM171|Myeloablative or submyeloablative conditioning regimen followed by an expanded cord blood transplant
16029699|NCT02668302|Combination Product|Steroid-eluting sinus implant|PROPEL (Intersect ENT, Inc., Menlo Park, CA), containing 370μg of mometasone furoate gradually released over 30 days
16029700|NCT02668302|Other|Post-op standard of care|Post-op standard of care including debridement, irrigation, and/or topical steroids
16029701|NCT02668289|Other|consent|At the initial screening examination, each subject will receive an informed consent form. Prior to signing the informed consent, one of the investigators or qualified staff will thoroughly discuss participation in the study with each subject, allocating time for questions and answers.
16029702|NCT02668289|Other|Screening|At the initial screening examination, complete medical and dental history will be obtained to verify eligibility.
16029703|NCT02668289|Other|Xray|each subject will undergo site-specific oral radiographic exam (new periapical radiographs will be obtained if needed) to evaluate potential study sites.
16029704|NCT02668289|Other|PVS Impressions|PVS impressions of the arch of interest will be obtained in order perform volumetric analysis of the area of interest.
16029705|NCT02668289|Other|Photographs|Intraoral photographs will also be taken and subsequent study visits will be planned.
16029706|NCT02668289|Other|CBCT|The patient will then be sent to the Department of Radiology at the College of Dentistry for a baseline CBCT and follow-up at 14 week CBCT. These CBCT's will be utilized to evaluate the hard tissue volume in comparison to the clinical volume of soft tissue.
16029707|NCT02668289|Other|Anesthesia|After appropriate local anesthetic is administered and anesthesia is achieved, the buccal tissue thickness will be measured and recorded.
16029708|NCT02668289|Procedure|Extraction|After the pre-extraction baseline measurements are recorded and adequate anesthesia is confirmed, minimally invasive extraction procedures will be initiated. All extractions will be performed by residents in the UI CoD Periodontics advanced education program.
16029709|NCT02668289|Other|Clinical measurements|Measuring soft tissue dimensions, bone thickness prior to and immediately after extraction and then after appropriate healing time frames.
16029710|NCT02668276|Other|Standard NCCN counseling|
16029711|NCT02668276|Other|Standard NCCN counseling and Oncotype DX results|
16029712|NCT02668263|Procedure|Surgery alone|Surgery
16029713|NCT02668263|Procedure|Surgery and Drain(s)|Drains inserted as per standard practice
16029714|NCT02668263|Procedure|Surgery and Quilting Sutures|Quilting sutures to mastectomy flaps
16029715|NCT02668250|Procedure|OPTI-AGED|OPTI-AGED is composed of a multi-parametric optimization strategy.
16029716|NCT02668250|Procedure|Usual Care|Patients receive the usual care.
16029717|NCT02668237|Other|OptiPAC|Molecular and urinary tests.
16029718|NCT02668237|Other|Usual care|Antibiotics for prevention.
16029719|NCT02668224|Device|Vibrasens|Transcutaneous vibrations are used. This device allows vibrations from 25 to 150 Hz with an amplitude of 1 mm. In our study the frequency used is 50 Hz.
16029720|NCT02668224|Other|Usual activities|The patients will perform their usual activities, to allow the comparison with a vibration programme. They will not have a specific training.
16029721|NCT02668211|Device|PROFEMUR Preserve Classic Femoral Components|
16029722|NCT02668198|Device|Olympus CF190 Colonoscope High definition white light|Standard endoscopic imaging technique
16029723|NCT02668198|Device|Olympus CF190 Colonoscope White light with near focus|Near focus mode is used to closely examine the area of prior EMR site.
16029724|NCT02668198|Device|Olympus CF190 Colonoscope Narrow band imaging|Narrow band imaging is utilized to examine the area of prior EMR.
16029725|NCT02668198|Device|Olympus CF190 Colonoscope Narrow band imaging with near focus|NBI with near focus to help closely examine the area of prior EMR site.
16029726|NCT02668198|Procedure|Biopsy|Biopsy to assess any evidence of residual neoplasia via standard histopathology assessment
16029727|NCT02668185|Drug|NK3R antagonist - AZD4901|Neurokinin 3 receptor antagonist
16029728|NCT02668185|Drug|Placebo|Placebo
16029729|NCT02668172|Drug|Pasireotide LAR 60 mg|as mono-therapy or in combination with pegvisomant
16029730|NCT02668172|Drug|Pegvisomant|only in combination with pasireotide LAR
16029731|NCT02668159|Dietary Supplement|Fish peptide supplement|6 capsules of fish peptide supplement (3g/each) administered prior to one of the OGTT
16029732|NCT02668159|Dietary Supplement|Vitamin D supplement|1 tablet of vitamin D3 (1000 UI) administered prior to one of the OGTT
16029733|NCT02668159|Dietary Supplement|Fish peptide + Vitamin D3 supplements|6 capsules of fish peptide (3g/each) + 1 tablet of vitamin D3 (1000 UI) administered prior to one of the OGTT
16029734|NCT02668159|Dietary Supplement|Placebo|7 tablets of placebos administered prior to one the OGTT
16029735|NCT02668146|Drug|Perampanel|Study drug will be administered to study subjects
16029736|NCT02668146|Drug|Placebo|Placebo will be administered to study subjects
16029737|NCT02668133|Dietary Supplement|the nutritional supplement to be used in this trial is a SQ-LNS|Small quantity lipid nutrient supplement (SQ-LNS) containing 6 mg iron and 8 mg zinc per 20 g sachet (per day
16029885|NCT02667054|Drug|RX0041 8%|Anesthetic
16029886|NCT02667041|Device|NeuroQore rTMS Device|
16029738|NCT02668133|Dietary Supplement|lipid-based nutrient supplement (SQ-LNS) with phytase|• Small quantity lipid nutrient supplement (SQ-LNS) containing 6 mg iron and 8 mg zinc per 20 g sachet (per day). Exogenous phytase (projected concentration ~500 FTU/20 g SQ-LNS) added during manufacturing
16029739|NCT02668133|Dietary Supplement|0.9 mg isotopically enriched 67Zn,0.30 mg isotopically enriched 70Zn, 0.60 mg non-enriched zinc|delivered orally in sugar solution
16029740|NCT02668133|Dietary Supplement|1 mg isotopically enriched 68Zn|administered intravenously
16029741|NCT02668107|Other|Hammock positioning|Babies in the intervention group (IG), will be positioned supine in a hammock(hammock positioning) in the incubator, with the appropriate postural adjustments.
16029742|NCT02668094|Drug|Lidocaine|
16029743|NCT02668094|Drug|Pregabalin|
16029744|NCT02668094|Drug|propofol|
16029745|NCT02668081|Procedure|Endoscopic papillary balloon dilation|treatment of endoscopic papillary balloon dilation
16029746|NCT02668081|Procedure|Endoscopic sphincterotomy|treatment of endoscopic sphincterotomy
16029747|NCT02668068|Procedure|large volume whole-lung lavage (WLL)|Generally 1000 ~ 2000ml each time, 14 ~ 10 times totally, each side of the lung to 20 ~ 15 liters, until the lavage fluid from the black into a colorless clear clarification
16029748|NCT02668068|Biological|clinical grade umbilical cord mesenchymal stem cells|10^6 (1 million) /Kg/person cells of clinical grade umbilical cord MSCs will be injected after whole-lung lavage
16029749|NCT02668055|Biological|TB4|Computing area was in proportion to the slow-release Tb4 collagen and chitosan porous sponge scaffolds skin substitute cells stick in the wound surface
16029750|NCT02668042|Biological|liveness tissue skin|liveness tissue skin safety and effectiveness for the treatment of difficult to heal wounds
16029751|NCT02668029|Drug|oxygen|information already included in arm/group descriptions.
16029752|NCT02668029|Drug|medical air|Placebo
16029753|NCT02668016|Drug|Atorvastatin|Atorvastatin 20mg tablets taken orally once daily for one month.
16029754|NCT02668016|Other|Placebo|Placebo tablets taken orally once daily for one month
16029755|NCT02668003|Behavioral|Cognitive Behavioural Therapy|The CBT intervention, delivered by telephone, will consist of an initial assessment, 6 weekly sessions, and then booster sessions at 3 and 6 months. The intervention will be delivered by trained and accredited therapists. Participants will be supported by a self-management CBT manual. There will be a patient-centred assessment by the therapist for problem identification, risk assessment and development of a shared formulation of the current health problem. The sessions will involve education about musculoskeletal pain, somatic symptoms and specific CBT techniques such as pacing of activity, behavioural activation, diary keeping, identifying and challenging negative and unhelpful thinking patterns and the development of a longer term management plan.
16029756|NCT02667990|Other|orthopaedic stilettoe|stilettos with orthopaedic in-sole buildt into the shoe
16029757|NCT02667990|Other|standard stiletto|standard stiletto without insole
16029758|NCT02667990|Other|comfy trainer|comfy trainer
16029759|NCT02667977|Other|0.9 Normal Saline|Use of 0.9 Normal Saline for maintenance IV fluids
16029760|NCT02667977|Other|0.45 Normal Saline|Use of 0.45 Normal Saline for maintenance IV fluids
16029761|NCT02667964|Other|spiroergometry|Spiroergometry on a bicycle ergometer
16029762|NCT02667951|Other|A home-based caregiver-training program|A home-based caregiver-training program consisted of two weekly sessions, each lasting 2 to 3 hours. Following the training sessions, further assurance and consultation were provided in monthly telephone follow-ups, and progress in behavior management was evaluated.
16029763|NCT02667938|Drug|HCP1303 capsule 5/0.2mg|
16029764|NCT02667938|Drug|HCP1303 capsule 5/0.4mg|
16029765|NCT02667938|Drug|HGP1201|
16029766|NCT02667938|Drug|HCP1303 capsule 5/0.2mg placebo|
16029767|NCT02667938|Drug|HCP1303 capsule 5/0.4mg placebo|
16029768|NCT02667938|Drug|HGP1201 placebo|
16029769|NCT02667925|Drug|Intraperitoneal cisplatin with nanocis|Patients will receive an intraperitoneal chemotherapy combined to a radiotracer in order to assess the intraperitoneal distribution of the chemotherapy
16029772|NCT02667899|Device|deep brain stimulation|Deep brain stimulation means stimulate the brain with DBS.
16029773|NCT02667899|Device|transcranial magnetic stimulation|Transcranial magnetic stimulation means stimulate the brain with magnetic stimulation.
16029774|NCT02667899|Other|Routine treatment|Means without above additional treatment.
16029775|NCT02667886|Drug|X4P-001|Continuous, oral, once-daily dosing
16029776|NCT02667886|Drug|axitinib|Continuous, oral, twice-daily dosing
16029777|NCT02667873|Drug|SL-801|SL-801 is a small molecule inhibitor of the nuclear export protein Exportin-1 (XPO1).
16029778|NCT02667860|Procedure|Intracorporeal anastomosis.|Iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Echelon Endopatch and closure of the defect with running suture or another firing of Echelon Endopatch. The surgical specimen will be retrieved through a Pfannenstiel incision.
16029779|NCT02667860|Procedure|Extracorporeal anastomosis|A transverse incision in the right upper quadrant will be performed. An iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Proximate Linear Cutter device and Proximate Stapler.
16029780|NCT02667860|Device|Echelon Endopatch|Use of an Echelon Endopatch Powered Device to perform an ileocolonic side-to-side anastomosis.
16029781|NCT02667860|Device|Proximate Linear Cutter|Use of a Proximate Linear Cutter device to perform a side-to-side ileo-colonic anastomosis.Use of a Proximate stapler to the closure of the defect associated with the creation of the side-to-side ileo-colonic anastomosis.
16029782|NCT02667834|Behavioral|Social Cognition and Interaction Training (SCIT)|A randomized, controled trial of social cognition and interaction training ( SCIT) for patients with schizophrenia Spectrum disorders
16029783|NCT02667834|Behavioral|therapeutic education program (ETP)|usual treatment ,30 hours with therapist, only discussion between patients
16029784|NCT02667821|Other|Head positions and spinal manipulation|Each participant will undergo three separate test maneuvers. Neutral (0° rotation) neck position (condition 1) will be followed by block randomization between maximum voluntary rotation (condition 2) and a high-velocity-low-amplitude cervical manipulation targeted at C1-C2 (condition 3). Conditions 1 and 2 will be held for 1 minute before returning to neutral alignment. For the manipulation, the head will be repositioned at neutrality immediate. An experienced practitioner will perform the manipulation on the adjustable and pivotal MRI bed. After each condition, MRI of the upper neck and cerebrum for perfusion and blood flow will ensue.
16029785|NCT02667808|Other|Focus Group|Subjects will participate in four to eight group discussions aimed to evaluate fertility intentions, family planning, and sexual health behaviors. Discussions will be 1-2 hours in length. Groups will be conducted among men and women.
16029786|NCT02667808|Other|Questionnaire|Participants will complete a questionnaire assessing reproductive health knowledge, attitudes and practices related to family planning, and fertility and sexual health. The questionnaire will take no longer than 30 minutes to complete.
16029787|NCT02667795|Other|Monitored walking based exercise|Monitored walking based exercise
16029788|NCT02667782|Behavioral|Mindfulness-Based Stress Reduction (MBSR)|Recruited subjects that are randomly allocated into the MBSR group will have an intensive face-to-face (F-T-F) teaching-learning program that is focused on stress reduction. After that, there will be some regular telephone follow-ups for a closed group of 10-15 participants. Subjects would receive four consecutive weekly F-T-F sessions, then a weekly telephone follow-up for three months in combination with an F-T-F session once a month. The Interventionist will be an experienced mindfulness therapist who is qualified to deliver both MBSR and MBCT.
16029789|NCT02667782|Behavioral|Mindfulness-Based Cognitive Therapy (MBCT)|Recruited subjects that are randomly allocated into the MBCT group will have an intensive face-to-face (F-T-F) teaching-learning program that is focused on cognitive therapy. After that, there will be some regular telephone follow-ups for a closed group of 10-15 participants. Subjects would receive four consecutive weekly F-T-F sessions, then a weekly telephone follow-up for three months in combination with an F-T-F session once a month. The Interventionist will be an experienced mindfulness therapist who is qualified to deliver both MBSR and MBCT.
16029790|NCT02667769|Other|Fasting day|A day of fasting started at 18.00 clock with a blood glucose test and is only started when on the same day no significant hypoglycemia (blood glucose <55 mg / dl) occurred, and when at 18.00 clock the blood sugar in the defined target range (70-180 mg / dl) is. Carried out during the fasting day standardized blood samples for measurement of plasma glucose with an appropriate laboratory method at 18.00, 20:00, 22:00, 12:00, 2:00, 4:00, 6:45, 9:00, 12:00, 14:00 and again at 18.00 clock. Because the determination of plasma glucose in the laboratory will take some time, is always for guidance and also measured with a fast measurement method, in order to treat at high levels of blood sugar with additional insulin correction, and to treat hypoglycaemia low blood sugar or to prevent hypoglycaemia.
16029791|NCT02667756|Other|Non-interventional|
16029792|NCT02667743|Drug|Paclitaxel Micelles for Injection|
16029793|NCT02667743|Drug|Paclitaxel Injection|
16029794|NCT02667743|Drug|Cisplatin|
16029795|NCT02667730|Drug|Acetaminophen|Acetaminophen 500 mg four times daily for 7 days
16029796|NCT02667730|Drug|Naproxen|naproxen 500mg twice daily for 7 days
16029797|NCT02667730|Drug|Celecoxib|celecoxib 100mg twice daily
16029798|NCT02667730|Other|physiotherapy only|physiotherapy only (no drug)
16029799|NCT02667717|Behavioral|Mirror therapy|The intervention is a mirror therapy. The mirror therapy consists in performing some movements with a mirror, the hand that is painful is hidden and the image of the healthy hand is reflected in the mirror. Patients looking at this image seems to see their painful hand moving.
16029800|NCT02667717|Behavioral|Usual care|Patients will have the usual care as an intervention.
16029801|NCT02667704|Drug|Bosentan|
16029802|NCT02667704|Drug|Nintedanib|
16029803|NCT02667691|Dietary Supplement|SODB Dimpless|Subjects are supplemented with SODB, daily over 3 Months. Each volunteer was seen for the 4 visits: - visit of pre-inclusion, - visit V1, so-called inclusion visit, - visit V2 at 1,5 months and - visit V3 at 3 months
16029804|NCT02667691|Dietary Supplement|Placebo|Subjects are supplemented with placebo, daily over 3 Months. Each volunteer was seen for the 4 visits: - visit of pre-inclusion, - visit V1, so-called inclusion visit, - visit V2 at 1,5 months and - visit V3 at 3 months
16029805|NCT02667691|Other|caloric restriction|Caloric recommendation reduced by 20%
16029806|NCT02667678|Biological|Cohort HIVOL, patients infected by HIV|Researchers will take blood and urinary samples from the patients of the HIVOL cohort, to look at the renal clearance. The aim of this study is to check the renal function of the patients infected by HIV.
16029807|NCT02667652|Procedure|short biliarypancreatic limb|biliarypancreatic limb:50cm;roux limb:150cm.
16029808|NCT02667652|Procedure|long biliarypancreatic limb|biliarypancreatic limb:100cm;roux limb:100cm.
16029809|NCT02667639|Biological|RPH-104|Anti-IL-1 Mab
16029810|NCT02667639|Other|Sodium chloride Sterile Injection 0.9% w/v|Sterile saline solution
16029811|NCT02667626|Other|Reproductive Health Survivorship Care Plan (SCPR)|The reproductive health survivorship care plan (SCPR) is a web-based educational tool that will include information on how to manage various reproductive health issues such as hot flashes, fertility concerns, contraception practices, and sexual function. The intervention also includes additional web-based information and resource lists, text-based reproductive health and study adherence prompts.
16029812|NCT02667626|Other|Control|Web-based resource lists and text-based study adherence reminders
16029813|NCT02667613|Other|HABIT-ILE|Hand and arm bimanual intensive therapy including lower extremities
16029814|NCT02667613|Other|Control|Usual customary care
16029819|NCT02667574|Drug|ERIVEDGE|
16029820|NCT02667561|Drug|Testosterone gel 1% 2.2 mg|Application of 220 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.
16029887|NCT02667028|Procedure|PCI|percutaneous coronary intervention
16135140|NCT01896349|Drug|sulpiride|
16029821|NCT02667561|Drug|Testosterone gel 1% 4.4 mg|Application of 440 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.
16029822|NCT02667561|Drug|Testosterone gel 1% 8.8 mg|Application of 880 mg of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.
16029823|NCT02667561|Drug|Placebo of Testosterone Gel 1%|Application of approximately 550 mg of Placebo of Testosterone Gel 1% in pubic region, once daily, for 28 consecutive days.
16029824|NCT02667548|Procedure|PCI|percutaneous coronary intervention
16029825|NCT02667535|Drug|Isosorbide Mononitrate|"Healthy volunteers will receive 2g (2.0%) of investigational product at a single dose, and will undergo a washout period of 7 days; subsequently, they will receive 2g of investigational product once daily, for 7 consecutive days.
~Participants with anal fissure will receive 2g of investigational product, either at 0.5%, 1.0% or 2.0%, at a single dose, and will undergo a washout period of 7 days; subsequently, they will receive 2g of investigational product, either at 0.5%, 1.0% or 2.0%, once daily, for 7 consecutive days."
16029826|NCT02667522|Behavioral|Parent Child Interaction Therapy (PCIT)|PCIT includes 12-16 sessions across two phases: the first focused on enhancing positive parenting during child-directed interactions, and the second focused on reducing harsh parenting during parent-directed interactions. Parents receive feedback and coaching on their interactions with the child during sessions.
16029827|NCT02667496|Drug|Sargramostim GZ402664|Pharmaceutical form:solution Route of administration: subcutaneous
16029828|NCT02667496|Drug|Placebo|Pharmaceutical form:solution Route of administration: subcutaneous
16029829|NCT02667496|Drug|Florbetapir F18|Pharmaceutical form:solution Route of administration: intravenous
16029830|NCT02667483|Drug|DS-5141b|DS-5141b, Subcutaneous injection
16029831|NCT02667470|Drug|Solifenacin|Oral
16029832|NCT02667457|Radiation|99mTc-rhAnnexin V-128|
16029833|NCT02667444|Drug|SB204 4%|Applied topically once daily
16029834|NCT02667444|Drug|Vehicle Gel|Applied topically one daily
16029835|NCT02667418|Drug|Fidaxomicin|200 mg PO twice daily for 10 days
16029836|NCT02667418|Drug|Vancomycin with Taper/Pulse|125 mg PO four times daily for 10 days, followed by 125 mg once daily x 7 days, then once every other day x 7 days, then once every 3rd day x 7 days
16029837|NCT02667418|Drug|Vancomycin|125 mg PO for times daily for 10 days
16029838|NCT02667405|Procedure|Hot Pack|Patients have a hot pack and 2 layers of towel wrapped around the wrist and forearm for 15 minutes
16029839|NCT02667405|Procedure|Whirlpool|Patients immerse their arm, from elbow to hand, in a whirlpool bath of 104 degrees Fahrenheit for 15 minutes
16029840|NCT02667392|Procedure|Gait Training with Biofeedback|"Intervention (12, 60-minute sessions, 3X/week for four weeks) will occur in an outpatient research setting. Participants will be supervised by a licensed physical therapist and wear a gait belt during all activities. The therapist will choose from a standardized bank of gait activities, suitable to each participant's ability level. The goal for total walking time for each session will be 50 minutes: 5, 10-minute bouts with a 2-minute rest between bouts. This is the typical length and intensity of outpatient rehabilitation sessions for ambulatory patients discharged from inpatient rehabilitation.
~Biofeedback Group: Biofeedback (external-focus feedback) will be provided as an adjuvant to therapist-provided feedback during the intervention. Participants will be instructed that a tone will sound when they push off with their (paretic) leg to swing it forward when the participant-specific pre-programmed threshold is exceeded."
16029841|NCT02667392|Procedure|Gait Training with Verbal Feedback|"Intervention (12, 60-minute sessions, 3X/week for four weeks) will occur in an outpatient research setting. Participants will be supervised by a licensed physical therapist and wear a gait belt during all activities. The therapist will choose from a standardized bank of gait activities, suitable to each participant's ability level. The goal for total walking time for each session will be 50 minutes: 5, 10-minute bouts with a 2-minute rest between bouts. This is the typical length and intensity of outpatient rehabilitation sessions for ambulatory patients discharged from inpatient rehabilitation.
~Verbal Feedback Group: Therapist-provided internal-focus feedback (directed towards components of body movement) will be used to instruct participants on achieving and/or maintaining appropriate movement patterns that contribute to propulsion generation."
16029842|NCT02667379|Other|Diagnostic skin testing|14 Skin prick tests on each volar forearm with cat dander samples.
16029843|NCT02667366|Behavioral|Tel-PT|
16029844|NCT02667366|Behavioral|TAU and text messages|
16029845|NCT02667353|Procedure|ECT|ECT was administered twice a week with a constant-current brief-pulse device (Thymatron, System IV). Motor and electroencephalographic seizures were monitored to ensure adequate duration and quality. Subjects were all treated with right unilateral (RUL) ECT with stimulus intensity 6 times the initial seizure threshold (ST), as determined by empirical dose titration at the first treatment, until remission (Montgomery-Åsberg Depression Rating Scale (MADRS) (27) < 10 in two consecutive ratings with a week interval). Subjects who failed to respond right unilateral ECT after the sixth treatment were switched to bitemporal ECT (1.5x seizure threshold).
16029846|NCT02667353|Drug|Etomidate|Anesthesia was achieved with intravenous administration of etomidate (0.2mg/kg).
16029847|NCT02667353|Drug|Succinylcholine|Anesthesia was achieved with intravenous administration of succinylcholine (1mg/kg).
16029848|NCT02667340|Dietary Supplement|Superstarch|0.7 g Superstarch or placebo per kg body mass in two ingestions (before game & at halftime)
16029849|NCT02667340|Other|Placebo|0.7 g glucose per kg body mass in two ingestions (before game & at halftime)
16029850|NCT02667327|Drug|Granexin gel|Granexin gel contains active pharmaceutical ingredient, aCT1 peptide, for topical application to diabetic foot ulcers once a week for up to 12 weeks or until wound closure, whichever comes first.
16029851|NCT02667327|Other|Vehicle gel|The vehicle gel formulation is hydroxyethyl cellulose that does not contain the active aCT1 peptide. Vehicle gel will be applied topically to diabetic foot ulcers once a week for up to 12 weeks or until wound closure, whichever comes first.
16029852|NCT02667314|Behavioral|Jigsaw puzzles|"Intervention period 1: Participants are asked to solve jigsaw puzzles at home 6 times per week for at least 1 hour over a period of 5 weeks.
~Intervention period 2 (voluntary): Participants receive the possibility to solve jigsaw puzzles free-of-charge at home for a period of at least 3 month before the 1.5-year follow-up."
16029888|NCT02667015|Behavioral|Psychotherapy (Anxiety Sensitivity Intervention)|3 week, 6-session psychotherapy targeting anxiety sensitivity
16030200|NCT02664779|Other|Arrhythmia diagnosis with the 4 steps method|
16029853|NCT02667314|Behavioral|Cognitive health counseling|Cognitive health counseling regarding modifiable risk and protective factors of cognitive decline and dementia at baseline, and four telephone calls for expert monitoring (three calls during the 5-week period between pre- and posttest, and one call 12 month later)
16029854|NCT02667301|Device|EMG recording|1.3X0.4 mm, sterile subdermal monopolar needle electrodes along with the same type of reference needle electrodes were inserted mTVP and mLVP muscles submucosally through the soft palate trans orally. The point of insertion for mTVP was one mm inferior and lateral of the pterygoid hamulus which is palpable at the posterior-medial of the upper alveolus. The active electrode was fully inserted horizontally into the superior belly of mTVP on the tested side. The reference electrode for mTVP was inserted into the palatine aponeurosis at one centimeter apart from the active electrode. The point of insertion for the mLVP active electrode was one centimeter medial and five mm inferior to the hamulus pterygoideus. Reference electrode of mLVP was inserted into one cm apart of medial side of the passive electrode of the mTVP at palatine aponeurosis.
16029855|NCT02667301|Device|Tympanic Cavity Air Exchange Test|Tympanic cavity air exchange test is done by placing a sensitive pressure sensor in the ear canal and another pressure sensor on one of the nostrils. Patient is asked to to obstruct the other nostril with his/her index finger while holding the probe in place securely and asked to swallow the water during the next ten seconds. Both ear canal and nasal pressure values were simultaneously recorded on tympanic cavity air exchange sensor computer for subsequent analyses. The swallowing action triggers the ET opening and causes a momentary increase of pressure in the nasal cavity. ET opening moves the tympanic membrane which is sensed by the sensors.
16029856|NCT02667301|Device|Tympanometer test|Patient is subjected to tympanometry test on the specific ear and information is recorded.
16029857|NCT02667288|Drug|A-101 Solution|
16029858|NCT02667275|Drug|A-101 Solution|
16029859|NCT02667275|Other|Vehicle Solution|Placebo
16029860|NCT02667262|Other|Algorithm to identify patients experiencing opioid abuse/addiction|
16029861|NCT02667249|Other|clinical pathway|implementation of a standardized clinical pathway
16029862|NCT02667236|Drug|A-101 Solution|Active Drug
16029863|NCT02667236|Other|Vehicle Solution|Placebo
16029864|NCT02667223|Biological|Cohort 1: bococizumab 150 mg + rHuPH20|bococizumab 150 mg + rHuPH20 administered SC to healthy volunteers
16029865|NCT02667223|Biological|Cohort 2: bococizumab 300 mg|bococizumab 300 mg administered SC to healthy volunteers
16029866|NCT02667223|Biological|Cohort 3: bococizumab 300 mg + rHuPH20|bococizumab 300 mg + rHuPH20 administered SC to healthy volunteers
16029867|NCT02667223|Biological|Cohort 5: bococizumab 450 mg + rHuPH20|bococizumab 450 mg + rHuPH20 administered SC to healthy volunteers
16029868|NCT02667223|Biological|Cohort 4: bococizumab 300 mg + rHuPH20|bococizumab 300 mg + rHuPH20 administered SC to subjects with hypercholesterolemia receiving a statin
16029869|NCT02667210|Other|Medical Record Review|Medical Record Review of Behaviors Suggestive of Misuse, Diversion, Abuse and/or Addiction
16029870|NCT02667197|Other|Algorithm to determine overdose from opioid abuse|
16029871|NCT02667184|Dietary Supplement|Low FODMAP Oral Nutrition Supplement|
16029872|NCT02667171|Behavioral|Supervised COPD Rehabilitation (control group)|"The control group receives standardized conventional supervised COPD rehabilitation (CCR) in groups. Rehabilitation contains exercise training and education sessions twice a week for a duration of 8-12 weeks. The CCR will last 60-120 minutes each session (50% exercise and 50% education).
~Physical Exercises in CCR consist endurance based at Borg dyspnea 4-7 for 20-30 minutes and resistance training for upper and lower limb at 50-80% of one repetition maximum of 2-3 sets. Educations sessions consist information a dialogue regarding, life with COPD, participants topics, Medication, daily activity, Nutrition, Smoking cessation, Respiratory and relaxation exercises."
16029873|NCT02667171|Behavioral|Online COPD rehabilitation (experimental)|"Supervised Online COPD rehabilitation, delivered in groups through a computer screen in patients own home. Rehabilitation contains exercise training and education sessions three times per week for a duration of 10 weeks. Each session lasts for 60minutes (60% exercise 40% education). Physical exercises consist high repetitive time-based muscle endurance training, including 5-7 upper and lower limb exercises, performed with a volume of four sets per exercise equivalent to 50-80% of one repetition. Self-rated Borg CR-10 score equivalent from moderate to very strong shortness of breath in active phases.
~Educations consists same information as for the control group."
16029874|NCT02667158|Other|Survey to Eval Relation between Shopping and Misuse, Abuse|A Survey Study to Evaluate the Relation Between Doctor/Pharmacy Shopping and Outcomes Suggestive of Misuse, Abuse and/or Diversion
16029875|NCT02667145|Other|Self care program focusing on the assistive device|self-heed program focusing on the assistive device will consist of four weekly meetings lasting approximately 90 minutes. it will be stimulated the self-heed through knowledge of pathology and guidelines of protection articulate, and will be supplied, and trained the use of assistive devices to improve the performance of volunteers in their daily activities. Assistive devices are devices, not attached to the body, which help people with limited movements and restrictions on participation in the activities of everyday life. Example: thickening of tableware, tin openers. These volunteers will be evaluated in three stages: 1-initial assessment 2-after completion of the program and 90 days after the initial assessment. The questionnaires that will be used are: EVA; SACRAH; COPM; WHOQOL-Bref.
16029876|NCT02667119|Behavioral|Prolonged Exposure with Contingency Management|"Prolonged Exposure therapy for posttraumatic stress disorder includes psychoeducation, breathing retraining, in vivo exposure, and imaginal exposure.
~Contingency Management for substance abuse disorders: participants will have the chance to win prizes for each negative urine drug screen/breathalyzer provided."
16029877|NCT02667119|Behavioral|Standard Care|Standard care will consist of treatment as usual in a community-based substance use treatment center.
16029878|NCT02667106|Drug|RX0041-2|Pharmacokinetic study
16029879|NCT02667080|Other|2-7 days of Sexual abstinence|2-7 days of Sexual abstinence
16029880|NCT02667080|Other|2 hours of sexual abstinence|2 hours of sexual abstinence
16029881|NCT02667067|Device|Simplify Disc|Simplify Disc at one level in the cervical spine.
16029882|NCT02667067|Device|Anterior Cervical Discectomy & Fusion|"This study will utilize a non-concurrent historical control with subject-level data on a parallel group design. The historical control group will be formed from the randomized ACDF arm (N=133) of the recently completed Kineflex®|C Disc trial."
16029883|NCT02667054|Drug|RX0041 4%|Anesthetic
16029889|NCT02667002|Procedure|Bilateral Abdominal Sacral Hysteropexy|The mesh will be fixed right and left side of sacrum.
16029890|NCT02667002|Procedure|Conventional abdominal Sacral Hysteropexy|The mesh will be fixed only right side of sacrum
16029891|NCT02667002|Other|Nulliparous women with no uterovaginal prolapsed|This will be control group which consistent patients with no uterovaginal prolapse.
16029892|NCT02666989|Drug|placebo|2 placebo pills twice a day
16029893|NCT02666976|Drug|Ilaprazole|Patients who were diagnosed clinically as NERD and were treated with ilaprazole 20mg once daily for 4 weeks. Biopsies were obtained from 3cm above the EG junction before and after treatment. GERD Q questionnaire, histologic findings (basal cell hyperplasia, papillary elongation, dilated intercellular spaces, intraepithelial eosinophils and intraepithelial T lymphocyte) and inflammatory biomarkers (TNF-α, IL-8, IL-1β, TRPV1 and MCP-1) were accessed.
16029894|NCT02666963|Drug|RTA 901 Capsules, 10 or 40 mg|
16029895|NCT02666963|Drug|Placebo|
16029896|NCT02666950|Drug|Cytarabine|Given SC
16029897|NCT02666950|Other|Laboratory Biomarker Analysis|Correlative studies
16029898|NCT02666950|Other|Pharmacological Study|Correlative studies
16029899|NCT02666950|Other|Quality-of-Life Assessment|Ancillary studies
16029900|NCT02666950|Other|Questionnaire Administration|Ancillary studies
16029901|NCT02666950|Drug|WEE1 Inhibitor AZD1775|Given PO
16029902|NCT02666924|Dietary Supplement|Chinese-canadian specific cooking classes|Series of four, four-hour cooking classes, occurring monthly for four months. Each of the cooking classes in the series will have diabetes self-management learning objectives: food choices, meal planning and preparation, portion control, self-monitoring of blood glucose levels and physical activity.
16029903|NCT02666924|Other|Diabetes educational classes|Series of two, four-hour diabetes education classes, occurring weekly for two weeks. Each class is run by a registered dietitian and nurse, trained as clinical diabetes educators, as per standards of the canadian diabetes association. Classes include focused teaching of the background of diabetes, dietary recommendations for diabetes, lifestyle recommendations for diabetes, medications for diabetes, and general standard of living recommended for diabetes mellitus type 2.
16029904|NCT02666911|Procedure|4D Ultrasound|Each subject will be imaged lying supine on imaging table with affected arm outstretched on Plexiglass board. An ultrasound scanner equipped with 15L8 linear array transducer will be set to depth of 20-25 mm with a 15MHz image acquisition frequency (for longitudinal and transverse imaging) and the same ultrasound machine equipped with 4D transducer will be used. Ultrasound evaluation will be performed by a sonographer trained in the pertinent image acquisition procedures. The image acquisition frame rate will be maintained at 70Hz, and the image compression will be set to low.
16029905|NCT02666911|Procedure|2D ultrasound|Each subject will be imaged lying supine on imaging table with affected arm outstretched on Plexiglass board. An ultrasound scanner equipped with 15L8 linear array transducer will be set to depth of 20-25 mm with a 15MHz image acquisition frequency (for longitudinal and transverse imaging) and the same ultrasound machine equipped with 4D transducer will be used. Ultrasound evaluation will be performed by a sonographer trained in the pertinent image acquisition procedures. The image acquisition frame rate will be maintained at 70Hz, and the image compression will be set to low.
16029906|NCT02666898|Drug|GA101|"Part 1 :6 cycles
~Obinutuzumab/GA101:
~First cycle:
~D1: 100mg, D2: 900mg D8 and D15: 1000 mg i.v
~Cycle 2 to 6 (every 28 days) :
~D1 of every cycle: 1000 mg i.v PART 2 4 cycles
~-patients have BM MRD >10-4 or PR: Cycle 1 to 4 Obitinuzumab/GA101: 1000 mg i.v on day 1"
16029907|NCT02666898|Drug|Ibrutinib|"Part 1 :6 cycles
~Cycle 2 to 6 (every 28 days) :Ibrutinib:
~D3 Month 1 to Day 30 Month 15: 420mg daily PO PART 2:4 cycles
~patients in CR with BM MRD < 10-4 : Ibrutinib alone 420mg daily
~patients with BM MRD >10-4 whatever responses or PR :Cycle 1 to 4 Ibrutinib 420mg daily with Cyclophosphamide and Fludarabine"
16029908|NCT02666898|Drug|Cyclophosphamide|"PART 2 :
~patients with BM MRD >10-4 or PR (except PD and SD), receive : 4 cycles of FC+GA101 every 28 days Cyclophosphamide : 250 mg/m² per os, D2 to D4 in association with GA101, ibrutinib and fludarabine"
16029909|NCT02666898|Drug|Fludarabine|"PART 2 :
~patients with BM MRD >10-4 or PR (except PD and SD), receive : 4 cycles of FC+GA101 every 28 days : Fludarabine : 40 mg/m² per os, D2 to D4 in association with GA101, ibrutinib and cyclophosphamide"
16029910|NCT02666885|Radiation|Integration of PET/MRI in radiotherapy|Integration of pretherapeutical PET/MRI in adjuvant radiotherapy
16029911|NCT02666872|Behavioral|Motivational interviewing|
16029912|NCT02666859|Device|Virtual Reality|During this intervention, the subjects will be immersed in a virtual reality system called the Computer Assisted Rehabilitation Environment (CAREN) system to complete the tasks.
16029913|NCT02666846|Drug|Ibuprofen|
16029914|NCT02666846|Drug|Diclofenac|
16029915|NCT02666846|Drug|Methyl-salicylate / Menthol|
16029916|NCT02666846|Drug|Placebo|
16029917|NCT02666833|Device|Polarization Enhanced Reflectance and Fluorescence System|Subjects will receive preoperative imaging of their skin cancer with the PERFIS optical imaging device.
16029918|NCT02666820|Procedure|Large balloon dilatation|After biliary sphincterotomy was performed with full extension to the full length of transverse fold. A 12, 15, 18 or 20 mm CRE-balloon was passed over guide wire and position across the papilla. The balloon was gradually inflated to the largest size of the bile duct stone and/or the bile duct diameter. When complete stone removal was unsuccessful , crossing over treatment was considered at the discretion of the endoscopists.
16029919|NCT02666820|Procedure|Mechanical lithotripsy|After biliary sphincterotomy was performed with full extension to the full length of transverse fold. A 3x6 cm Trapezoid Rx retrieval stone basket was used to capture the stone and crushing of stones was done when simple stone extraction failed to remove the stone. The stone fragments were then retrieved with a basket and/ or a retrieval balloon. When complete stone removal was unsuccessful , crossing over treatment was considered at the discretion of the endoscopists.
16029920|NCT02666807|Dietary Supplement|Ginger|Ginger 500 mg capsules (2000 mg per day) by mouth twice daily (BID) for 10 weeks
16029921|NCT02666807|Dietary Supplement|placebo|Placebo matching with ginger 0 mg capsules by mouth twice daily (BID) for 10 weeks
16029922|NCT02666794|Drug|Epidural bupivacaine with vasoconstrictor 0.125%|10 ml
16029923|NCT02666794|Drug|Epidural sufentanil|20 mcg
16029924|NCT02666794|Procedure|Placement of the epidural catheter|Placement of the epidural catheter
16029925|NCT02666794|Drug|Intrathecal hyperbaric bupivacaine solution 0.5%|2.5 mg
16029927|NCT02666794|Procedure|Placement of an epidural catheter to the catheter through technical needle|Placement of an epidural catheter to the catheter through technical needle
16029928|NCT02666794|Drug|Intrathecal sufentanil|5 mcg
16029929|NCT02666781|Other|ApneaLink Plus, BIA Device|The study is only observational. No interventions will be performed. ApneaLink Plus will be used to diagnose Obstructive Sleep Apnea in potential candidates and grade its severity on Postoperative night 2 in participants. A BIA Device will be used to detect segmental fluid shifts. A 3-D accelerometer will be used to detect head and neck position.
16029930|NCT02666768|Drug|Interferon gamma-1b|gamma interferon-1b dose escalation over first 4 weeks of study to 100 mcg SC 3 times weekly
16029931|NCT02666742|Drug|DOAC|DOAC is a blood thinning drug, also called direct oral anticoagulant. These group of drugs are approved by the U.S. Food and Drug Administration (FDA) for the treatment of stroke prophylaxis in atrial fibrillation and deep vein thrombosis and pulmonary embolism, which are blood clots in the veins or lungs.
16029932|NCT02666742|Drug|Aspirin|Aspirin works by reducing substances in the body that cause pain, fever, and inflammation. Aspirin is used to treat pain, and reduce fever or inflammation.
16029933|NCT02666729|Procedure|AF Ablation with contact force information|Ablation procedure will be done using TactiCath Quartz ablation catheter which can measure the amount of contact force being used. Researcher will be made aware of contact force data when performing procedure.
16029934|NCT02666729|Procedure|AF Ablation without contact force information|Ablation procedure will be done using TactiCath Quartz ablation catheter which can measure the amount of contact force being used. Researcher will not be made aware of contact force data when performing procedure.
16029935|NCT02666716|Drug|fluconazole|Dose according to summary of product characteristics (SPC) or local protocols
16029936|NCT02666703|Device|CytoSorb|CytoSorb is a first-in-class extracorporeal cytokine adsorber, now approved in the European Union, and broadly indicated for use in any clinical situation where cytokines are elevated.
16029937|NCT02666703|Drug|Methylprednisolone|
16029938|NCT02666690|Device|CEUS (Contrast-enhanced ultrasound)|Each patient will be performed 2 contrast echocardiography (a pre-prandial - a post-prandial) before the antiangiogenic treatment, at D15 and D30.
16029939|NCT02666664|Drug|ETC-1002|ETC-1002 180 mg tablets taken orally, once per day. Patients remain on ongoing statin therapy (not study provided)
16029940|NCT02666664|Drug|Placebo|Matching placebo tablets taken orally, once per day. Patients remain on ongoing statin therapy (not study provided)
16029941|NCT02666651|Drug|Tolvaptan|Tolvaptan is dispensed during hospitalization according to its product monograph and clinician discretion. It will be discontinued once serum sodium is normalized, or in the case of a drug related adverse event or hospital discharge.
16029942|NCT02666651|Other|No intervention|There is no intervention planned for the Control group. Aggregate administrative regional data describing patient outcomes from the local health authority will be used as a comparator.
16029943|NCT02666638|Other|Control Volunteers|MRI on up to a 7T scanner without contrast.
16029944|NCT02666638|Other|Clinical Volunteers|One-hour MRI on up to a 7T scanner without contrast + 10 minutes of research development imaging using radio frequency (RF) coils
16029945|NCT02666625|Procedure|saliva samples|
16029946|NCT02666625|Procedure|blood samples|
16029947|NCT02666612|Procedure|Blood samples|
16029948|NCT02666599|Radiation|18F-FDG PET/CT|"A 18F-FDG PET/CT will be done. A dose of 19 µSv/MBq will be received by the patient. Surgery will be conducted within 3 hours after the I.V. injection of 18F-FDG according to the standard procedure applied in the visceral surgery department. During the surgery, emission of β+ from the lesion (s) seen durint the PET/CT will be detected with the probe.
~Resected pieces will be analysed histologically."
16029949|NCT02666586|Other|Faba bean powder smoothie|Breakfast smoothie with 32 g whole faba bean powder (300g).
16029950|NCT02666586|Other|Faba bean protein concentrate smoothie|Breakfast smoothie with 32 g faba bean protein concentrate.
16029951|NCT02666586|Other|Faba bean starch smoothie|Breakfast smoothie with 33 g faba bean starch.
16029952|NCT02666586|Other|Faba bean protein isolate smoothie|Breakfast smoothie with 32 g faba bean protein isolate.
16029953|NCT02666586|Other|Non-pulse smoothie smoothie|Control smoothie with 32 g corn maltodextrin without added faba bean fractions.
16029954|NCT02666573|Device|Fotosan 630, CMS Dental, Copenhagen, Denmark|The PDT system consists of a hand-held rechargeable light-emitting diode (LED) light source (Fotosan® 630 device, CMS Dental, Copenhagen, Denmark) and 0.1 mg/mL toluidine blue photosensitiser. The LED light source has a wavelength between 620 to 640 nm and peak of 630 nm and a power density between 2000 to 4000 mW/cm2.
16029955|NCT02666573|Other|Scaling and root planing|Scaling and root debridement of the residual pockets were performed using ultrasonic device and hand curettes until root surfaces felt hard and smooth. The sites were then polished using rubber cup and prophylaxis paste.
16029956|NCT02666560|Device|Auditory Cueing|Auditory cueing set at different frequency rates
16029957|NCT02666547|Drug|68Ga-NODAGA-RGD PET/CT|200 MBq 68 Ga-NODAGA-RGD will be administered i.v. and images acquired on all body . For glioma, images acquired centred on the skull
16029958|NCT02666547|Radiation|18F-FDG PET/CT|3.5 MBq/kg 18F-FDG will be administered i.v. and images acquired on all body
16029959|NCT02666547|Radiation|18F-FET PET/CT|200 MBq 18F-FET will be administered i.v. and images acquired centred on the skull
16029960|NCT02666534|Drug|lidocaine-prilocaine 5% cream application|The lesions were then cleansed with saline gauze, and a lidocaine-prilocaine 5% cream (EMLA®; Astra Pharmaceuticals, LP, Westborough, MA, USA) was applied to the treatment area for 30 min under occlusion
16029961|NCT02666534|Device|2940-nm Er:YAG AFL pretreatment|After the anesthetic cream was removed, AFL was performed using a 2940-nm Er:YAG AFL (Joule; Sciton, Inc., Palo Alto, CA, USA) with a 500 µm ablation depth, level 1 coagulation, 22% treatment density, and a single pulse
16029962|NCT02666534|Drug|methyl-aminolevulinate application|Immediately after the AFL, a 1-mm thick layer of methyl-aminolevulinate (16% Metvix® cream; PhotoCure ASA, Oslo, Norway) was applied to the lesion and to 5 mm of the surrounding healthy tissue. The area was covered with an occlusive dressing (Tegaderm; 3M, Co., Saint Paul, MN, USA) for 3 h, after which the remaining cream was removed with saline gauze, and the red fluorescence of porphyrins was visualized with Wood's light.
16030112|NCT02665351|Drug|Peramivir|The two regimens of Peramivir were compared
16135324|NCT01894724|Device|NeuroSave device|
16029963|NCT02666534|Device|Illuminating using red light-emitting diode lamps|Each treatment area was then separately illuminated using red light-emitting diode lamps (Aktilite CL128; Galderma S.A., Bruchsal, Germany) with peak emission at 632 nm and a total light dose of 37 J/cm2. Areas scheduled to receive MAL-PDT received the second treatment 7 days later. During the illumination, patients were asked to evaluate pain intensity using an 11-point visual analog scale.
16029964|NCT02666508|Other|Plaque identifying toothpaste|Plaque identifying toothpaste with targetol
16029965|NCT02666508|Other|Non-plaque identifying toothpaste|Non-plaque identifying toothpaste without targetol
16029966|NCT02666495|Other|Psychological Therapy - Schema Therapy|Psychological treatment using individual Schema-Mode Therapy for Anorexia Nervosa (iST-AN). A 60 session protocol will be used over an 18 month period, moving flexibly through five phases of treatment, guided by the psychological formulation: phase 1 - assessment, engagement & stabilisation; phase 2 - developing trust & understanding; phase 3 - developing awareness & acceptance; phase 4 - testing change & strengthening the healthy mode; phase 5 - consolidating change. A follow-up period of 6 months, with 5 further monthly sessions, will promote self-efficacy and further consolidate change. A total treatment package of 65 sessions will be offered, over 24 months.
16029967|NCT02666482|Behavioral|Stop Smoking SF Web App - baseline|Smoking cessation web app in Spanish and English. Accessible online at no charge.
16029968|NCT02666469|Other|Hyperbaric Oxygen Therapy (HBOT) and Exercise Program|HBOT provided with 100% oxygen at 2.0 ATA and rehabilitation program consisting of GRASP (60 min) and mental imagery (30 min)
16029969|NCT02666469|Other|Exercise Program|Rehabilitation program consisting of GRASP (60 min) and mental imagery (30 min)
16029970|NCT02666469|Device|Hyperbaric Multiplace Chamber|Patients will receive treatment in a multiplace Hyperbaric Chamber
16029971|NCT02666456|Other|QST, Questionnaires|Assessment of sensory phenotype by QST and questionnaires
16029972|NCT02666443|Drug|Control intervention (no dexamethasone)|Patients receive a supraclavicular brachial plexus block with 30 mL of solution containing 0.5% bupivacaine, 1:400,000 epinephrine, 0.1 mL normal saline, and an intravenous solution of 50 mL normal saline.
16029973|NCT02666443|Drug|Peri-neural Dexamethasone 1 mg|Patients receive a supraclavicular brachial plexus block with 30 mL of solution containing 0.5% bupivacaine, 1:400,000 epinephrine, 0.1 mL dexamethasone 1% (1 mg dexamethasone), and an intravenous solution of 50 mL normal saline.
16029974|NCT02666443|Drug|Intravenous Dexamethasone 1 mg|Patients receive a supraclavicular brachial plexus block with 30 mL of solution containing 0.5% bupivacaine, 1:400,000 epinephrine, 0.1 mL normal saline, and an intravenous solution of 49.9 mL normal saline with 0.1mL dexamethasone 1%
16029975|NCT02666430|Drug|Mylan's insulin glargine|
16029976|NCT02666430|Drug|Lantus®|
16029977|NCT02666417|Dietary Supplement|Fortified maize porridge (MNP+iron)|Maize porridge will be home-fortified with the MNP + iron. Maize porridge for the test meal will be fortified with labelled iron compounds
16029978|NCT02666417|Dietary Supplement|Fortified maize porridge (MNP+iron+GOS)|Maize porridge will be home-fortified with the MNP + iron + GOS. Maize porridge for the test meal will be fortified with labelled iron compounds
16029979|NCT02666404|Other|Measurement|We will perform those new measurements and assessments for guidance of fluid resuscitation at 0, 6, 24, 48, and 72 hours after shock diagnosis and concomitant fulfillment of eligibility requirements
16029980|NCT02666391|Biological|umbilical cord mesenchymal stem cells|
16029981|NCT02666378|Other|Cardiac Magnetic Resonance Imaging (CMR)|Subjects will be recruited for observational cardiac magnetic resonance imaging.
16029982|NCT02666378|Other|Echocardiogram (ECHO)|Subjects will undergo a research echocardiogram if a clinical echocardiogram has not already been ordered.
16029983|NCT02666365|Procedure|Bolus infusion of Cefazolin|Subjects in the bolus infusion arm of the study will receive bolus infusions of cefazolin throughout the surgical procedure
16029984|NCT02666365|Procedure|Continuous infusion of Cefazolin|Subjects in the continuous infusion arm of the study will receive a continuous infusion of the cefazolin throughout the surgical procedure
16029985|NCT02666352|Drug|Uprifosbuvir|A single dose of uprifosbuvir 450 mg (given as three 150-mg tablets) taken by mouth.
16029986|NCT02666352|Drug|Ruzasvir|A single dose of ruzasvir 60 mg (given as six 10-mg capsules) taken by mouth.
16029987|NCT02666339|Other|Usual care|Usual care : drug therapy, nurse and physician consultations.
16029988|NCT02666339|Behavioral|Hortitherapy|2 hortitherapy sessions/week during 4 weeks, added at the usual care.
16029989|NCT02666326|Procedure|Accelerated, combined biomarker rule-out strategy for MI|Blood sample is acquired while the patient is in the ambulance. This is brought to hospital and handed over to the laboratory personnel for acute analysis for copeptin level. At arrival to hospital, a second blood sample is acquired and analyzed for high-sensitive cardiac troponin-T(hs-cTnT). Answers of these analyzes are in-hand with-in 60 minutes. If copeptin in the pre-hospital blood sample is <9,8 pmol/L (95% percentile) AND hs-cTnT in the in-hospital blood sample is <14ng/L (99% percentile), then myocardial infarction can be ruled out, and depending of clinical presentation, the patient can be discharged.
16029990|NCT02666313|Behavioral|Exercise|"The physiotherapist will select exercises which are appropriate to that participant. Participants will complete online exercise diaries which are reviewed remotely by the physiotherapist. Depending on progress, exercises can be progressed, added or removed from the patient's individualised programme.
~Participants will be encouraged to undertake their exercise programme, according to evidence base guidelines, five days/week for 30 minutes/day. Participants will receive weekly phone calls for the first two weeks of the programme. Thereafter, every two weeks the physiotherapist will review the exercise diary of each participant and remotely alter the participant's exercise programme as appropriate, by changing any combination of exercises, level of difficulty or number of repetitions."
16029991|NCT02666300|Other|TaperGuard ETT|tracheal intubation with TaperGuard ETT
16029992|NCT02666287|Drug|BAT/FF|BAT/FF is available in DPI form and will be administered via the ELLIPTA inhaler. Each first strip contains 300 mcg per blister of BAT blended with lactose and its physical appearance is dry white powder. Second strip contains 100 mcg per blister of FF blended with lactose and its physical appearance is dry white powder.
16029993|NCT02666287|Drug|BAT|BAT is available in DPI form and will be administered via the ELLIPTA inhaler. Each first strip contains 300 mcg per blister of BAT blended with lactose appear as dry white powder. Second strip contains lactose which appear as a dry white powder.
16136327|NCT01887132|Drug|Placebo|
16029994|NCT02666287|Drug|FF|FF is available in DPI form and will be administered via the ELLIPTA inhaler. Each first strip contains 100 mcg per blister of FF blended with lactose appear as dry white powder and second strip contains lactose which appear as dry white powder.
16029995|NCT02666287|Drug|FF (MgSt)|FF magnesium stearate is available in DPI form and will be administered via the ELLIPTA inhaler. Each first strip contains 100 mcg per blister of FF blended with lactose appear as dry white powder and second strip contains lactose with magnesium stearate which appear as dry white powder.
16029996|NCT02666287|Drug|FF/Vilanterol|FF/Vilanterol is available in DPI form and will be administered via the ELLIPTA inhaler. Each first strip contains 25 mcg per blister of vilanterol blended with lactose and magnesium stearate appear as dry white powder and second strip contains 100 mcg per blister of FF blended with lactose which appear as dry white powder.
16029997|NCT02666235|Procedure|Remote ischaemic conditioning|Intermittent inflation of an arm blood pressure cuff for 5 minute periods at 200 mmHg separated by a 5 minute rest interval, repeated successively on 4 occasions over a 40 minute period. The intervention will take place on the ward with the patient obscured from the clinical team by a drawn curtain. The clinical team and researchers will be masked to the intervention type.
16029998|NCT02666235|Procedure|Arm cuff placement, no inflation;|Sham procedure involving arm cuff placement, no inflation: A blood pressure cuff will be placed on the arm for 40 minutes. The cuff will not be inflated. The patient will be in bed behind a curtain on the cardiology ward. The curtain will obscure the patient from the attending cardiology team. The clinical team and researchers will be masked to the intervention type.
16029999|NCT02666222|Device|The Esteem Hearing Implant|The Esteem® Hearing Implant is designed to improve hearing in subjects suffering from moderate to severe hearing loss that is sensorineural in origin. The Esteem® has been approved by FDA for the US market under Pre-Market Approval P090018 and this study fulfills the requirement for one of the Post Approval Studies.
16030000|NCT02666209|Drug|Ulocuplumab|CXCR4 inhibitor given weekly on a 28 day cycle intravenously
16030001|NCT02666209|Drug|Lenalidomide|immunomodulatory agent given days 1-21 of a 28 day cycle orally in subjects not receiving bortezomib
16030002|NCT02666209|Drug|Bortezomib|proteasome inhibitor given at physician discretion in subjects not receiving lenalidomide
16030003|NCT02666209|Drug|Dexamethasone|steroid given at physician discretion on a 28 day cycles
16030004|NCT02666196|Drug|DAA-I|
16030005|NCT02666196|Drug|Placebo|
16030006|NCT02666183|Behavioral|Video-C|use videoconferencing to provide personalized information aimed at enhancing self -efficacy and providing emotional support for distant caregivers of patients with advanced cancers
16030007|NCT02666183|Behavioral|Nurse Coaching|structured conversations with registered nurses aimed at providing emotional support
16030008|NCT02666183|Behavioral|Web-Only|Access to a website with caregiving resources, resources for distant care givers, and cancer information
16030009|NCT02666170|Drug|Alpha-lipoic acid|
16030010|NCT02666157|Drug|Dabigatran etexilate|this drug is administered twice per day for the entire study period
16030011|NCT02666157|Drug|Rivaroxaban|this drug is administered once per day for the entire study period
16030012|NCT02666157|Drug|Apixaban|this drug is administered twice per day for the entire study period
16030013|NCT02666144|Device|Spectralis OCT|Measurement of structural parameters of the optic nerve head (ONH), in particular, the neuroretinal rim of the ONH, and the peripapillary retinal nerve fiber layer.
16030018|NCT02666105|Drug|Exemestane|One 25 mg tablet once daily for a minimum of 6 weeks
16030019|NCT02666092|Other|Questionnaire|Questionnaire on domestic exposure to fish, and, for patients with fish allergy, on the characteristics of clinical manifestations)
16030020|NCT02666092|Biological|Detection of anti-Anisakis and anti-fish antibodies|Anti-fish IgE will be detected using ImmunoCAP. Anti-Anisakis antibodies will be detected using ImmunoCAP (IgE), immunoelectrophoresis (precipitins) and Western Blot.
16030021|NCT02666079|Device|LightPath® Imaging System.|Intra-operative use of the LightPath® Imaging System.
16030022|NCT02666053|Drug|BMS-663068|BMS-663068
16030113|NCT02665338|Device|Transcranial Magnetic Stimulation|
16031264|NCT02657330|Drug|SBP-101|Subcutaneous drug, escalating dose cohorts
16030023|NCT02666040|Device|ULTRAPRO® meshes|The inguinal hernia repair has to be performed with the Lichtenstein technique, with standardized prosthesis fixation and no use of plug.
16030024|NCT02666040|Device|"Prolene® meshes"|The inguinal hernia repair has to be performed with the Lichtenstein technique, with standardized prosthesis fixation and no use of plug.
16030025|NCT02666040|Procedure|Detecting the mode of admission to hospital|Ordinary admission or day surgery
16030026|NCT02666040|Procedure|Duration of surgery|Time operating room
16030027|NCT02666040|Procedure|Anesthesia volume and type used|Anesthesias used: infiltration, followed by spinal, general, epidural.
16030028|NCT02666027|Device|Fluid Intravenous Alert (FIVA) 'on'|Fluid Intravenous Alert (FIVA) 'on' - The FIVA™ (EngenuityMED, Halifax, Canada) is a small, handheld, battery operated, device class I medical device in Canada (Figure 1). It is designed to alarm and alert the physician to change the IV bag when the fluid level in the chamber of the IV set is low. It also functions to stop the fluid flow through the gravity-fed tubing system when the alarm is triggered, preventing air from entering the IV tubing. We hypothesize that the FIVA would decrease the incidence of unnoticed dry IV bags during surgery, particularly when the operating room lights are dimmed and would therefore decrease the risks associated with undetected dry IV bags.
16030029|NCT02666027|Device|Fluid Intravenous Alert (FIVA) 'off'|The FIVA will be turned off. - The FIVA™ (EngenuityMED, Halifax, Canada) is a small, handheld, battery operated, device class I medical device in Canada. It is designed to alarm and alert the physician to change the IV bag when the fluid level in the chamber of the IV set is low. It also functions to stop the fluid flow through the gravity-fed tubing system when the alarm is triggered, preventing air from entering the IV tubing. We hypothesize that the FIVA would decrease the incidence of unnoticed dry IV bags during surgery, particularly when the operating room lights are dimmed and would therefore decrease the risks associated with undetected dry IV bags.
16030030|NCT02666014|Drug|Sugammadex|Reversal of neuromuscular blockade
16030031|NCT02666014|Drug|Neostigmine|Reversal of neuromuscular blockade
16030032|NCT02666001|Drug|BMS-663068|BMS-663068
16030033|NCT02666001|Drug|Methadone|Methadone
16030034|NCT02666001|Drug|Buprenorphine and Norbuprenorphine|Buprenorphine and Norbuprenorphine
16030035|NCT02665988|Device|tDCS|Prior to initiating the real tDCS trial and to reduce the likelihood of irritation associated with electrical stimulation, a low dose (1/8 of an inch) topical lidocaine (4%) cream will be applied to the skin where the tDCS the sponge-coated, surface electrodes soaked in saline solution will be placed. Neurotargeting tDCS-explorer software, Version 2.3 will be used to locate the left and right DLPFC, where anodal stimulation of the left DLPFC and cathodal stimulation of the right DLPFC will be received. Real tDCS will be applied during 20-minute periods over the course of 10 sessions. After each session, vitamin-E will be applied to the skin where the electrodes had been placed to reduce likelihood of skin irritation.
16030036|NCT02665988|Device|Sham tDCS|Participants randomized to sham tDCS will undergo the same procedures as those in the real tDCS sample, including the same pre-treatment lidocaine 4% cream, localization of electrode placement, actual placement of electrodes, turning on the tDCS device in sham setting but will not receive actual stimulation during the 20 minutes of each session, as well as post-treatment vitamin E.
16030037|NCT02665975|Behavioral|CBT-based internet-intervention for tinnitus|Tinnitus e-learning programme
16030038|NCT02665975|Behavioral|Face-to-face clinical tinnitus care|Hospital tinnitus counselling
16030039|NCT02665962|Other|Perioperative Caloric Restriction Program|
16030040|NCT02665936|Drug|Levobupivacaine|Levobupivacaine will be given epidurally and the duration of analgesia will be calculated
16030041|NCT02665936|Drug|Dexamethasone and levobupivacaine|dexamethasone 4 mg epidurally with levobupivacaine and duration of analgesia is measured
16030042|NCT02665936|Drug|Levobupivacaine and Dexamethasone|dexamethasone 8 mg epidurally with levobupivacaine and duration of analgesia is measured
16030043|NCT02665923|Other|Gastric ultrasound|Ultrasound of abdomen to assess antral volume
16030044|NCT02665910|Drug|SHR0302|Oral tablets (1 mg, 5 mg, 10 mg)
16030045|NCT02665910|Drug|SHR0302 placebo comparator|Oral tablets (1 mg, 5 mg, 10 mg) (matching corresponding study medication)
16030046|NCT02665884|Other|Intraocular Pressure Measurement|Diurnal fluctuations of intraocular pressure will be measured and compared
16030047|NCT02665871|Biological|one dose of Influenza Vaccine|
16030048|NCT02665871|Biological|one dose of Influenza Vaccine|
16030049|NCT02665871|Biological|placebo|
16030050|NCT02665871|Biological|placebo|
16030051|NCT02665858|Other|OCT Imaging|
16030052|NCT02665845|Drug|5-ASA|5ASA treatment (oral 5ASA will be given to all patients in this arm, in addition to topical 5ASA in patients who tolerate it).
16030053|NCT02665845|Drug|Corticosteroids|Corticosteroids will be given to all patients.
16030054|NCT02665832|Drug|DWJ1351|
16030055|NCT02665832|Drug|Co-administration of Sevikar (Olmesartan/Amlodipine) and Crestor (Rosuvastatin)|
16030056|NCT02665819|Other|Pediatric cancer women survivors|Women will incur a blood taking to obtain fertility indication.
16030057|NCT02665806|Drug|Ciclesonide|intranasal ciclesonide spray 200 µg once daily
16030058|NCT02665806|Drug|Fluticasone|fluticasone propionate aqueous nasal spray 200 µg twice a day
16030059|NCT02665793|Other|DBPCFC to peanut cookie|
16030060|NCT02665793|Other|Single-dose DBPCFC to peanut flour|Single-dose DBPCFC to peanut in a water-continuous matrix, at a cumulative dose one dosing level below that individual's threshold (established at the baseline challenge). If no reaction is seen, participants will be given the next dosing level.
16030061|NCT02665793|Other|Single-dose DBPCFC to peanut butter|Single-dose DBPCFC to peanut in a water-continuous matrix, at a cumulative dose one dosing level below that individual's threshold (established at the baseline challenge). If no reaction is seen, participants will be given the next dosing level.
16030062|NCT02665780|Procedure|Periodontal debridement|teeth cleaning
16030063|NCT02665780|Other|Cetylpyridium chloride|mouthrinse
16030105|NCT02665403|Other|control|Children received standard medical and nursing care, such as vital signs observation, pharmacological treatment and wound and pain management as a control treatment
16030106|NCT02665390|Procedure|Percutaneous cryoablation|Percutaneous cryoablation
16030107|NCT02665377|Drug|ANP|
16030108|NCT02665377|Drug|Placebo|
16030064|NCT02665767|Device|Smartphone-based Telesonography|The 30 participating examiners were randomly divided into two groups. In phase one, group A performed ultrasonography under onsite mentoring and group B performed the same procedure under remote mentoring. Each examiner was randomly assigned one expert and three SPs for phase one. Four weeks later, they were partnered with the same expert and SPs to whom they had been assigned in phase one and performed the procedure under the other type of mentoring (phase two). The examination order of the SPs was randomly assigned by choosing a number between one and six (1: A-B-C, 2: A-C-B, 3: B-A-C, 4: B-C-A, 5: C-A-B, 6: C-B-A) in each phase.
16030065|NCT02665754|Biological|ILIT with extract of causal allergen|0.5 ml of allergen extract from D. farinae, D. pteronyssinus, cat, and/or dog for allergen specific immunotherapy (Tyrosine S, Allergy Therapeutic, UK) will be injected into inguinal lymph node through guidance by ultrasonography three times with 4-week interval.
16030066|NCT02665754|Biological|ILIT with normal saline|0.5 ml of normal saline will be injected into inguinal lymph node through guidance by ultrasonography three times with 4-week interval.
16030067|NCT02665754|Drug|Rescue medication for allergic rhinitis|Subjects are requested to administer oral antihistamine (cetirizine) or nasal glucocorticosteroid (ciclesonide) as rescue medication for allergic rhinitis in accordance with severity and frequency of allergic rhinitis symptoms according to Allergic Rhinitis and its Impact on Asthma (ARIA) guideline.
16030068|NCT02665741|Device|Olympus transparent cap|distal colonoscope attachment
16030069|NCT02665741|Device|Medivators Endocuff|distal colonoscope attachment
16030070|NCT02665741|Device|Control|No distal colonoscope attachments
16030071|NCT02665728|Drug|BLI400 Laxative|
16030072|NCT02665715|Other|Low carbohydrate meals|Meal macronutritional energy composition: Carbohydrate 30% Protein 30% Fat 40%
16030073|NCT02665715|Other|Standard carbohydrate meals|Meal macronutritional energy composition: Carbohydrate 55% Protein 15% Fat 30%
16030074|NCT02665702|Drug|NVB|25mg/m2 ，D1，8
16030075|NCT02665702|Drug|DDP|75mg/m2 ，D1 or 25mg/m2 D1-3
16030076|NCT02665702|Drug|Endostar|15mg/d，d1-d7 civ
16030077|NCT02665689|Drug|ranibizumab|Ranibizumab injections will be given for diabetic macular edema. In the experimental arm insulin injections and antihypertensiva will be applied.
16030078|NCT02665663|Device|medical device|
16030079|NCT02665650|Biological|AFM13|
16030080|NCT02665650|Biological|Pembrolizumab|
16030081|NCT02665637|Drug|Trastuzumab|Each patient may receive single dose by intravenous infusion
16030082|NCT02665624|Drug|Senna and stewed apricot juice|comparison of bowel cleansing and patient comfort.
16030083|NCT02665624|Drug|Senna alone|comparison of bowel cleansing and patient comfort.
16030084|NCT02665611|Behavioral|intervention for improvement of adherence|intervention for improvement of adherence
16030085|NCT02665611|Behavioral|treatment as usual|The control group will be treated according to the usual stadard of care.
16030086|NCT02665585|Procedure|Carotid stenting procedure by carotid stent implantation|Carotid stenting procedure by carotid stent implantation
16030087|NCT02665572|Behavioral|bladder recycling|Bladder recycling will be done by the patient after proper education. It will be started by the instillation of the sterile water in the bladder in amount equal to the estimated bladder capacity. Then the amount will be gradually increased till the patient can withstand filling the bladder with 300 cc of sterile water for 2 hours.
16030088|NCT02665533|Drug|Dexamethasone|Dexamethasone 8 mg
16030089|NCT02665533|Drug|Diclofenac Sodium associated with Codeine|Diclofenac Sodium 50 mg associated with Codeine 50 mg
16030090|NCT02665520|Procedure|liposuction for retrieval of own stem cells from fat cells|
16030091|NCT02665507|Device|GaAlAs 808nm laser|Hand held superpulsed GaAlAs 808 nm LLLI
16030092|NCT02665507|Device|Sham|Hand held laser that emits no LLLI
16030093|NCT02665481|Behavioral|MBSR|
16030094|NCT02665481|Behavioral|Exercise|
16030095|NCT02665481|Behavioral|Health Education|
16030096|NCT02665468|Behavioral|Supported adoption intervention|An intervention where a healthcare system implements quality improvement by sending patients proactive reminders, motivational messages, and educational support to encourage use of a new service (i.e., secure messaging)
16030097|NCT02665468|Behavioral|Active comparator control|The investigators will use an attention control (a control intended to balance the attention Veterans receive from the facility mailings and to enhance masking of intervention versus control). As an attention control must not have information about the intended intervention, the investigators will mail out general wellness information available on the VHA National Center for Prevention
16030098|NCT02665455|Device|FreeStyle Libre Flash Glucose Monitoring System|"Subjects will wear the FreeStyle Libre Flash Glucose Monitoring System masked for 14 days.
~During these 14 days subjects will be asked to perform 4 blood glucose tests (pre-meals and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed."
16030099|NCT02665442|Device|Esophageal Stylet - EsoSure|The Esophageal Stylet is a thin rigid tube, which will be inserted inside a commonly used nasogastric tube placed inside the esophagus during the ablation. We will use this stylet to move the esophagus away from the site of the ablation about 1-2 centimeters.
16030100|NCT02665429|Behavioral|Individual prescribing data profile and self-assessment|Prior to receiving his or her individual data profile, each provider in the intervention group will be asked to identify his or her self-assessment of his or her own opioid prescribing practices. Immediately after providing self-perception data, providers will be provided with their true profile data with a visual display of where they fall within the distribution of their peers. All peer data are de-identified.
16030101|NCT02665416|Drug|Selicrelumab|Selicrelumab will be provided as concentrate for solution to be administered via SC injection
16030102|NCT02665416|Drug|Vanucizumab|Vanucizumab will be provided as solution to be administered via IV infusion.
16030103|NCT02665416|Drug|Bevacizumab|Bevacizumab will be administered via IV infusion.
16030104|NCT02665403|Other|Play intervention|participants received around 30 minutes of hospital play interventions each day, conducted by hospital play specialists. Such interventions consisted of structured and non-structured activities. All these activities were given at the patients' bedside, with or without parental supervision, either once or spreading over an hour, depending on the ward routine.
16030109|NCT02665364|Biological|IFNα-Kinoid|
16030110|NCT02665364|Other|Placebo|
16030114|NCT02665325|Drug|TSH-suppressive therapy|Thyroidectomy according to the China thyroid association guidelines for the Management of thyroid nodule and thyroid cancer; followed by TSH-suppressive therapy 6 /12 months.
16030115|NCT02665286|Drug|Orphenadrine|Orphenadrine 100mg PO BID x 7 days
16030116|NCT02665286|Drug|Methocarbamol|Methocarbamol 750mg 1-2 tabs po TID x 7 days
16030117|NCT02665286|Drug|Naproxen|Naproxen 500mg PO BID x 7 days
16030118|NCT02665286|Drug|Placebo|1/2 of placebo packages will be dosed to match methocarbamol: 1-2 tabs po TID x 7days 1/2 of placebo packages will be dosed to match orphenadrine: 1 tab PO BID x 7 days
16030119|NCT02665273|Procedure|Greater occipital nerve block|Bilateral greater occipital nerve block
16030120|NCT02665273|Drug|Bupivacaine|0.5 cc of 0.5% bupivacaine injected intradermally
16030121|NCT02665260|Drug|Cantharidin|cantharidin 0.7% topical liquid
16030122|NCT02665260|Drug|Placebo|Placebo topical liquid
16030123|NCT02665260|Device|Gauze occlusion bandage|Gauze occlusion bandage with adhesive tape
16030124|NCT02665247|Behavioral|C-SIP|In session I, information about sleep and the effects of lack of sleep will be presented. Participants will also be presented with advice and tips on how to improve sleep. Session II will focus on assisting participants overcome any barriers they faced in applying the advice they received in session I; participants will also receive additional information on sleep and sleep-related techniques.
16030125|NCT02665247|Other|Dream discussion|Participants assigned to the control group will attend sessions in which information on sleep is presented in the form of dream discussions.
16030126|NCT02665234|Drug|1% Tavilermide Ophthalmic Solution|1% Tavilermide BID Dosing
16030127|NCT02665234|Drug|Placebo Ophthalmic Solution|Vehicle Ophthalmic Solution
16030128|NCT02665221|Other|No Treatment Arm|Participants randomized to the control group will have no topical treatment at the injection site of the first full dose of Plegridy.
16030129|NCT02665221|Drug|Topical Preparation H arm|Preparation H (phenylephrine) treatment first full dose incidence injection site reaction.
16030130|NCT02665208|Other|Treatment As Usual (TAU)|informational pamphlets and information from 1800 quit line + prescription for nicotine replacement therapy (NRT) based on on the quantity of baseline self-reported smoking, or nicotine replacement gum (2mg)
16030131|NCT02665208|Drug|Nicotine Replacement Therapies|a prescription for a nicotine replacement therapy (NRT) (i.e. nicotine replacement patches based on the quantity of baseline self-reported smoking, or nicotine replacement gum (2mg)
16030132|NCT02665208|Behavioral|Text Message Intervention (TMI)|
16030133|NCT02665195|Other|saliva specimen|
16030134|NCT02665195|Behavioral|questionnaire|
16030135|NCT02665182|Behavioral|Up-positioning of the testes|Patients in the experimental arm are asked to elevate their testes during the treatment.
16030136|NCT02665169|Behavioral|Supervised physical exercise|Supervised physical exercises in Taiji and weight training. Free use and access into municipal recreation and training facilities for one year.
16030137|NCT02665169|Other|Health counselling|Health counselling, fall prevention strategies at home, information concerning municipal recreational services available.
16030138|NCT02665156|Procedure|Intracorporeal stapled neobladder using robotic staplers|"Robot assisted radical cystecomy. Separate packages extended pelvic lymph node dissection up to aortic bifurcation. Totally intracorporeal orthotopic ileal neobladder with about 45 cm of ileum according to Vescica Ileal Padovana."
16030139|NCT02665143|Drug|Nintedanib and AML induction|The AML induction regimen combines Idarubicin 12mg/m2/d day 1 to 3 and Cytarabine 0.667g/m2/d CIV day 1 to 3. In the phase I part, all patients will receive the combination with Nintedanib 200mg bid begun at day 8 and continued until end of cycle. If a significant incidence of dose limiting toxicities is demonstrated, Nintedanib will be given at a lower dose level (150mg bid).
16030140|NCT02665130|Other|Tai-chi plus Indacaterol|Participants perform Tai-chi exercise 5 days/week and take indacaterol 150ug/day for 24 weeks
16030141|NCT02665130|Other|Pulmonary rehabilitation plus Indacaterol|Participants perform conventional exercise 5 days/week and take indacaterol 150ug/day for 24 weeks
16030142|NCT02665117|Drug|Potassium Magnesium Citrate (KMgCit)|KMgCit will be administer for 4 months with chlorthalidone.
16030143|NCT02665117|Drug|Potassium Chloride (KCl)|KCl will be administer for 4 months with chlorthalidone.
16030144|NCT02665117|Drug|Chlorthalidone|Chlorthalidone will be administered for 2-3 weeks. Then either KCL or KMgCit will be added to Chlorthalidone and the combination will be taken for 4 months.
16030145|NCT02665104|Device|transcranial Doppler (TCD) and INVOS monitor|Bilateral transcranial Doppler measurements of the blood flow velocity within the middle cerebral arteries: 1. before local anesthesia, 2. after the onset of local anesthetic, but before skin incision, 3. intraoperatively before clamping the internal carotid artery, 4. one minute after clamping the internal carotid artery, 5. five minutes after clamping the internal carotid artery, 6. fifteen minutes after clamping the internal carotid artery, 7. directly after the restoration of blood flow in the internal carotid artery, 8. postoperatively, 4-6 hours after the intervention.
16030146|NCT02665091|Behavioral|Peer Education Program|
16030147|NCT02665078|Other|Thoracoscopic Ultrasound|We will evaluate the resected specimen using the XLTF-UC180 in the operating room (OR) to determine the localization rate of the targets. Ultrasound measurement and images will be compared to the actual size of the tumor and pathological morphology using HE slides of lung tumor to determine the correlation between those variables. The tumor depth from the lung surface will be also collected to clarify the maximum depth to which the ultrasound can visualize.
16030148|NCT02665065|Drug|Iomab-B|
16030149|NCT02665065|Drug|Conventional Care|
16030150|NCT02665065|Procedure|HCT|
16030151|NCT02665052|Device|Home-Based BATRAC plus TTT|Home-based BATRAC training will consist of 60 minutes of training at home (45 minutes using the BATRAC and 15 minutes of TTT) using the BATRAC training will include high intensity bilateral reaching and rest periods using the BATRAC followed by 15 minutes of video guided transition to task training (TTT). These videos will be linked from the VA MyHealtheVet site to study specific Youtube videos of the study therapist demonstrating the exercise. Asynchronous communication between the therapist and participant will be completed using the MyHealtheVet secure messaging system.
16030197|NCT02664792|Other|Use of [18f]FDG - PET/CT for the diagnosis and staging of non-small cell lung carcinoma|
16030198|NCT02664779|Other|Arrhythmia diagnosis with the 10 steps method|
16030152|NCT02665052|Device|Lab-based BATRAC plus TTT|Lab-based BATRAC will consist of 60 minutes of training in the lab (45 minutes using BATRAC and 15 minutes of TTT). BATRAC training will include high intensity bilateral reaching and retrieving actions (pushing handles away and pulling them back) on a constrained linear track to promote maximum arm extension. This training will be followed by 15 minutes of transition to task training (TTT) with supervision and support as needed by the therapist.
16030153|NCT02665052|Behavioral|Delayed Entry Usual Care|Participants randomized to this group will initially serve as a control for the first 6 weeks of the study and not receive any study interventions except the protocol study evaluations in the same time intervals as those receiving active interventions and weekly phone calls to record general activity level.
16030154|NCT02665039|Drug|Vinflunine|"Vinflunine will be given intravenously once every 21 days, starting at a dose of:
~280 mg/m2 in patients with GFR 40-60 ml/min
~250 mg/m2 in patients aged >80 years and/or GFR 30-40 ml/min"
16030155|NCT02665039|Drug|Gemcitabine|Gemcitabine will be given intravenously on day 1 and day 8 of every 21 day cycle, starting at a dose of 1000 mg/m2
16030156|NCT02665039|Drug|Carboplatin|Carboplatin will be given intravenously once every 21 days, starting at a dose of AUC 4.5
16030157|NCT02665026|Procedure|stoma closure at different times|Early closure: stoma closure in 12 weeks after surgery for rectal cancer; Late group: stoma closure in 24 weeks after surgery for rectal cancer
16030158|NCT02665013|Behavioral|Tailored|Pregnant women will be recruited to the study. The intervention will be delivered to participants prior to the child's 2 month well child visit, when the child is between 4 and 6 months of age, and when the child is 10-12 months of age. The first intervention occurs at enrollment in the study. Participants in the tailored intervention arm will receive vaccine information tailored specific to her concerns and values at each intervention point.
16030159|NCT02665013|Behavioral|Untailored|Pregnant women will be recruited to the study. The intervention will be delivered to participants prior to the child's 2 month well child visit, when the child is between 4 and 6 months of age, and when the child is 10-12 months of age. The first intervention occurs at enrollment in the study. Participants in the untailored arm will receive vaccine information at each intervention time point, but it will not be tailored to her specific concerns.
16030160|NCT02665000|Procedure|Structured training programme|Participants will undergo 5-days training sessions
16030161|NCT02664987|Other|Patients receiving cancer pain treatment|
16030162|NCT02664974|Dietary Supplement|Enteral nutrition|"Home Enteral Nutrition was planned to cover the basal energy requirement calculated with Harris Benedict Formula, it was administrated preferentially during nocturnal hours as an integration of oral diet.
~Enteral Nutrition included any standard polymeric formula providing 1-1.5 Kcal/mL with carbohydrates 50%-60%, lipids 25%-35% and protein 12%-20%.
~Home Enteral Nutrition can be withdrawn in the treated group, after 2 months from discharge, whenever a weight gain ≥ 5% is reported, and oral alimentation is regular and adequate."
16030163|NCT02664974|Other|Dietary counseling|"Specific nutritional advices including total energy and protein requirements were provided to patients and oral high-calorie supplements were prescribed whenever necessary.
~Home Enteral Nutrition can be started in patients of the control group, not before two months from discharge, if a further weight loss ≥ than 5% is reported."
16030164|NCT02664961|Drug|TRC105|Subjects will begin by receiving TRC105 weekly. Subjects who achieve a complete response on single agent TRC105 may transition to every two week dosing.
16030165|NCT02664961|Drug|Bevacizumab|Bevacizumab will be dosed every two weeks.
16030166|NCT02664948|Procedure|Early geriatric follow-up after discharge|Multidisciplinary assessement and intervention by physician, nurse and physiotherapist
16030167|NCT02664935|Drug|AZD4547|FGFR Inhibitor
16030168|NCT02664935|Drug|Vistusertib|MTORC1/2 Inhibitor
16030169|NCT02664935|Drug|Palbociclib|CDK4/6 Inhibitor
16030170|NCT02664935|Drug|Crizotinib|ALK/MET/ROS1 Inhibitor
16030171|NCT02664935|Drug|Selumetinib|MEK Inhibitor
16030172|NCT02664935|Drug|Docetaxel|Taxane, anti-mitotic cytotoxic chemotherapy
16030173|NCT02664935|Drug|AZD5363|AKT Inhibitor
16030174|NCT02664935|Drug|Osimertinib|EGFRm+ T790M+ Inhibitor
16030175|NCT02664935|Drug|Durvalumab|Anti-PDL1
16030176|NCT02664935|Drug|Sitravatinib|VEGFR Inhibitor
16030177|NCT02664935|Drug|AZD6738|ATR inhibitor
16030178|NCT02664922|Drug|Propofol|"1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.
~1 of 2 sedation groups for VT ablation and afib procedures."
16030179|NCT02664922|Drug|Ketamine|"1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.
~1 of 2 sedation groups for VT ablation and afib procedures."
16030180|NCT02664922|Drug|Remifentanil|1 of 3 sedation groups for SVT, RVOT/PVC ablation, and aflutter procedures.
16030181|NCT02664922|Drug|Sevoflurane|1 general anesthesia group for VT ablations and afib procedures.
16030182|NCT02664909|Drug|Tranexamic Acid|
16030183|NCT02664909|Drug|Placebo (saline)|
16030184|NCT02664896|Other|Knee Osteoarthritis|Questionnaire completion, strength testing, gait testing, pressure-pain threshold testing, proprioception testing, knee measurements, blood draw, and knee radiographs.
16030185|NCT02664896|Other|Healthy Control|Questionnaire completion, strength testing, gait testing, pressure-pain threshold testing, proprioception testing, and knee measurements.
16030186|NCT02664883|Procedure|Computed Tomography|Correlative studies
16030187|NCT02664883|Other|Cytology Specimen Collection Procedure|Undergo collection of blood and urine samples
16030188|NCT02664883|Other|Laboratory Biomarker Analysis|Correlative studies
16030189|NCT02664883|Procedure|Magnetic Resonance Imaging|Correlative studies
16030190|NCT02664870|Procedure|Arthroscopy|Arthroscopic Surgery on the hip, shoulder, or knee
16030191|NCT02664870|Procedure|Arthroplasty|Total hip, shoulder, or knee arthroplasty
16030192|NCT02664857|Drug|Vitamin D|Group D will take 600 IU vitamin D per orally during 12 weeks. At first day and end of the 12 weeks serum vitamin D level will analyse with laboratory testing
16030193|NCT02664857|Drug|Placebo|Group P will not take orally during 12 weeks. This group will only observe by researchers.
16030194|NCT02664844|Behavioral|Physical activity|
16030195|NCT02664805|Drug|LEO 124249 ointment|Ointment
16030196|NCT02664805|Drug|LEO 124249 ointment vehicle|Ointment vehicle
16136328|NCT01887119|Drug|Eplerenone|
16030201|NCT02664766|Behavioral|Exercise training program|Supervised 8-week exercise training program. Aerobic exercise (walking, jogging) of increasing duration at 50-60% HRR, at least two sessions per week. Participants will be recording their daily alcohol consumption. Participants will also undergo three trials of acute exercise (before, at the 4th week and at the 8th week of exercise training) in order to investigate whether exercise training can lead to changes in acute responses to exercise. Each trial involves 30 min of exercise on a cycle ergometer at 50-60% HRR.
16030202|NCT02664753|Drug|56 days of weight-adjusted L-Carnitine treatment|"Patients in the experimental arm will receive 10 days of intravenous L-carnitine treatment followed by 46 days of oral L-Carnitine treatment.
~Day 1: a first bolus of 6g of L-Carnitine is administered with a syringe driver of 50 ml.
~Day 2 to Day 10: Two mini-perfusions are prepared each day, corresponding to 1 administration every 12 hours. 50 mg/kg/day (rounded up to the next gram) L-Carnitine is added to each syringes
~For the next 46 days, patients will take oral doses of L-Carnitine as follows:
~< à 60kg : 2g/day > 60kg : 3g/day If the patient leaves the hospital before D10, oral treatment can be initiated at the end of the hospitalization"
16030203|NCT02664753|Drug|10 days of intravenous placebo (isotonic saline)|"Patients in the placebo arm will receive 10 days of intravenous isotonic saline in a fashion analogous to the experimental arm (they study is thus blinded for the first 10 days and then open there afterwards).
~Day 1: 1 50ml syringe driver of 50 ml isotonic saline solution . Day 2 to Day 10 : Two syringe drivers of 50 ml of isotonic saline solution are prepared each day, one during the morning and one during the evening."
16030204|NCT02664740|Drug|Topical anti-Staphylococcus bacteriophage therapy|Patients randomized to the experimental arm will receive sterile compress dressings impregnated with a phage solution of 10^7 PFU/ml on days 0, 7 and 14 (unless the wound is already healed, i.e. phage solutions are not applied to healed wounds).
16030205|NCT02664740|Drug|Topical placebo corresponding to anti-Staphylococcus bacteriophage therapy|Patients randomized to the placebo arm will receive sterile compress dressings impregnated with a placebo solution on days 0, 7 and 14 (unless the wound is already healed, i.e. placebo solutions are not applied to healed wounds).
16030206|NCT02664727|Behavioral|The effects of acute exercise in heavy drinkers|A group of heavy drinkers and a group of healthy controls (individuals without alcohol use disorders) will cycle on a cycle ergometer for 30 min at 50-60% of HRR. Before and immediately after exercise blood will be drawn and psychological and physiological parameters will be measured.
16030207|NCT02664727|Behavioral|The effects of acute exercise in alcoholic patients|A group of alcoholic patients (10-14 days after detoxification) and a group of healthy controls (individuals without alcohol use disorders) will cycle on a cycle ergometer for 30 min at 55-60% of HRmax. Before and immediately after exercise blood will be drawn and psychological and physiological parameters will be measured.
16030208|NCT02664714|Other|PFMT|Participating volunteers of all groups will receive guidance about the anatomy and function of the pelvic floor muscles (PFM) and how to perform a properly contraction: as strong as possible and eliminating at the most the contraction of the gluteus, abdominals and adductors. For all groups it will be used the same protocol which was developed for this study, with progression parameters of the PFMT based on the recommendations for the strength training of the American College of Sports Medicine (VICKI, 2001).
16030209|NCT02664701|Other|Baseline evaluation with a psychiatrist|Baseline data and questionnaires are established.
16030210|NCT02664701|Other|Individual supportive therapy|6 sessions of individual supportive therapy with a psychologist, 1 session per week for 6 weeks
16030211|NCT02664701|Other|Cognitive behavioural group therapy|6 sessions of cognitive behavioural group therapy with a psychologist, 1 session per week for 6 weeks
16030212|NCT02664701|Other|Evaluations with a psychiatrist|Evaluation withs a psychiatrist in the 10 days following the end of psychotherapy, then at 3, 6, 9, and 12 months.
16030213|NCT02664688|Other|Lumbar stabilization exercises|"The home-exercise program included an initial phase, with use of therapeutic heat via a hot pack for 15 minutes at the lumbosacral region, stretching exercises of the thoracolumbar fascia, hip flexors, hamstrings plus the stabilization exercises to encourage stabilizing motor patterns and determine the neutral position of the spine, with the target in control of transversus and internal oblique abdominis, multifidus, pelvic floor muscles, and diaphragmatic breathing control. Progression stages included hot packs, stretching exercises, and lateral, anterior bridges, leg raises in supine position, and arm and leg lifts in quadruped position (bird-dog)"
16030214|NCT02664688|Other|Flexor exercises|The home-exercise program included a hot pack for 15 minutes and flexor exercises routine
16030215|NCT02664675|Procedure|Crown lengthening|After a local anesthesia, gingival tissue is removed around the teeth to extend the length of the crown for aesthetic or prosthetic matter.
16030216|NCT02664675|Procedure|Open Flap Debridement|"After local anesthesia, intra-sulcular incisions are done and a flap is released to access to the intra-bony defect.
~Granulation tissue is removed and carefully laid aside for further analysis. Interrupted sutures are done to close the flap."
16030217|NCT02664662|Other|tailored education|Tailored rehabilitated education is which fit for each breast cancer patients after surgery in clinic. We design three of tailored books for experimental group. Each patients will be tailored by three principles. First, the educated times and hours are depended on patients physical function and learning ability. Second, the material is depended on each patient's life experience. Finally, the educated content is depended on patient's operation method.
16030218|NCT02664649|Drug|Apixaban|"Investigational Product is open label apixaban 5 mg tablets taken orally two times a day for 12 months. Subjects with 2 or more of the following characteristics will take apixaban 2.5 mg tablets orally twice daily: age ≥80 years, body weight <60 kg, serum creatinine ≥1.5 mg/dL [133 μMol/L].
~- Also, subjects with severe renal insufficiency [calculated Creatinine Clearance (Cr.Cl.) (Cockroft-Gault) between 15-29 ml/min] will take apixaban 2.5 mg tablets orally twice daily"
16030219|NCT02664649|Drug|Standard of care|VKA or Antiplatelet therapy
16030220|NCT02664636|Procedure|Physiotherapy|"Physiotherapy regimen (days 0 to 60): orthopedic maintenance, work on trunk balance, sensorimotor techniques for restoration of motor skills, exercises for standing balance and walking. Sessions last 30 to 60 minutes depending on the fatigue of the subject and the level of recovery. They occur as daily sessions during the first two weeks and then two sessions / day.
~This is part of routine care."
16030255|NCT02664350|Behavioral|M.D. Anderson Symptom Inventory (MDASI)|This questionnaire will be completed at baseline and weeks 2, 4, 6 and 8.
16030256|NCT02664350|Genetic|OPRM1|Genetic testing of the OPRM1 will be performed after week 8.
16030221|NCT02664636|Procedure|Occupational therapy|"Occupational Therapy (days 0 to 60): Orthopaedic maintenance, exercises for sitting and standing balance, sensorimotor techniques for the restoration of motor skills, grip exercises. Sessions last 30 to 60 minutes depending on the fatigue of the subject and the level of recovery. 1 session is performed per day.
~This is part of routine care."
16030222|NCT02664636|Procedure|Functional near-infrared spectroscopy|During the therapy protocol, cortical activation measures using the fNIRS method will be conducted every 15 days (at Day0, Day 15, Day 30, Day 45 and Day 60 for 5 sessions in total) at the technical platform of the Grau du Roi physical therapy centre, during the completion of a standardized motor task (maintaining a level of force) using the healthy upper limb and the paretic upper limb.
16030223|NCT02664623|Procedure|Individual dietary consultations|Individual dietary consultations with a dietician will be held at inclusion, month 1 and month 3. Consults consist of a personal interview where the dietician delivers comprehensive information to the patient on how to optimize calcium intake and reduce the risk of fractures; the dietician questions the subject on his/her diet and reassesses the quality and quantity of calcium intake during the 3 days preceding the consultation through a survey calculation software based on data from CIQUAL.
16030224|NCT02664623|Procedure|Dietary advice sheet|"At the beginning neurological consult, patients will be delivered a dietary advice sheet called Grio."
16030225|NCT02664610|Behavioral|Text Messaging|hypertensive participants will be randomized to receive tailored, motivational text messages
16030228|NCT02664571|Device|Pet scan with FBB|"Patients will have a pet scan with Florbetaben (NEURACEQ : FBB). All other care corresponds to routine care.
~Florbetaben is used during pet scans to visualize beta amyloid plaques and cannot be a separate intervention in and of itself."
16030229|NCT02664571|Device|MRI scan|Subjects will have an MRI scan at inclusion.
16030230|NCT02664571|Biological|APO E genotyping|Subjects will have APO (apolipoprotein) E genotyping if not already known.
16030231|NCT02664558|Drug|ubenimex|
16030232|NCT02664558|Other|placebo|
16030233|NCT02664545|Device|BEAR Scaffold|A sponge, or scaffold, which is surgically placed between the torn ligament ends and sutures are used to repair the torn anterior cruciate ligament.
16030234|NCT02664545|Procedure|Tendon Graft|A graft of tendon (either two hamstring tendons from the back of the knee or bone-patellar tendon-bone graft from the front of the knee)
16030235|NCT02664532|Other|Miller group|Miller blade was used for laryngoscopy
16030236|NCT02664532|Other|Macintosh group|Macintosh blade was used for laryngoscopy
16030237|NCT02664519|Behavioral|Forearm exercise training|Subjects will be asked to squeeze a tennis ball repeatedly for at least 30 min/day for 28 days at an approximate rate of 20 squeezes/min.
16030238|NCT02664506|Behavioral|Word repetition after a time delay.|This is a behavioral intervention, Word repetition after a time delay. Individuals listen to words and repeat them after 5 or 10 seconds.
16030239|NCT02664493|Drug|Methylprednisolone|Steroid pulse therapy : Methylprednisolone 0.5 g daily for 3 days, followed by a tapered dose of 60 mg per day for a period of five days.
16030240|NCT02664480|Other|Salivary alpha-Amylases|Investigators will collect Salivary alpha-Amylases before and after ovulation
16030241|NCT02664467|Device|Philips EnergyUp EnergyLight HF3419/01|Bright light therapy (10'000 lux) for 60 minutes after wake-up
16030242|NCT02664467|Device|Philips EnergyUp EnergyLight HF3419/01|Placebo dim light (500 lux) for 60 minutes after wake-up
16030243|NCT02664454|Other|health care organization|"Nurse-led or GP-led Geriatric assessment combined with an educational seminar focused on GA and personalized care-plan as well as a dedicated hotline for general practitioners seeking a geriatric advice
~Interactive educational seminar Primary care"
16030244|NCT02664441|Drug|Exenatide|Weekly injections of active drug.
16030245|NCT02664441|Drug|placebo|Weekly placebo injections
16030246|NCT02664428|Dietary Supplement|PreBIOil|A daily dose of about 90 gram will be given for 8 weeks
16030247|NCT02664428|Dietary Supplement|Control|A daily dose of about 90 gram will be given for 8 weeks
16030248|NCT02664415|Biological|VRC01|40 mg/kg; administered IV
16030249|NCT02664415|Biological|Placebo for VRC01|Sodium Chloride for Injection 0.9%, USP; administered IV
16030250|NCT02664389|Genetic|Genetic analysis|Sequencing of 200 selected genes in the different study populations
16030251|NCT02664376|Other|Sarcopenia detection|"The assessment of sarcopenia is performed according to the recommendations of the EWGSOP (European Working Group on Sarcopenia in Older people). Three measurements are made:
~Muscle mass measurement by dual energy X-ray absorptiometry (DEXA).
~Walking speed measurement
~Hand grip test
~A diagnosis of sarcopenia is established if the walking speed is inferior to 0.8 m/sec, the muscular strength is low and the muscular mass is low.
~Data regarding the geriatric characteristics of this sarcopenic population will be collected."
16030252|NCT02664363|Biological|EGFRvIII CAR T cells|The name of the drug is CAR gene-modified T cells or abbreviated as EGFRvIII CARs. The class of action is a biological and the mechanism of action is cytotoxicity. The drug substance is autologous T cells transduced with a retroviral vector encoding for a chimeric antigen receptor (CAR) directed against the tumor specific antigen, EGFRvIII. EGFRvIII CARs are genetically engineered T cells that have been taken from patients with GBM ex vivo to express a CAR recognizing the GBM tumor-specific antigen EGFRvIII, which is expressed on a subset of GBMs but not in normal human tissues with the aim of mediating regression of their tumors. Patients' CARs will be radiolabeled with 111In for correlative studies in the expanded cohort.
16030253|NCT02664350|Genetic|CYP2D6|Gentic testing for CYP2D6 metabolic pathway will be performed at baseline.
16030254|NCT02664350|Behavioral|Brief Pain Inventory-Short Form (BPI-SF)|This questionnaire will be completed at baseline and weeks 2, 4, 6 and 8.
16030536|NCT02662244|Device|Nd:YAG laser|Long-Pulsed 1064 NM ND:Yag Laser Treatment Of Basal Cell Carcinoma
16030257|NCT02664337|Other|Decision tool|A survey will be created for each condition that reflects the most important aspects of the corresponding treatment process.
16030258|NCT02664337|Other|Standard treatment information|Participants will receive information pertaining to one of the 12 specified musculoskeletal conditions. This information will reflect information commonly distributed to patients seeking to make a decision concerning treatment for their condition.
16030259|NCT02664311|Device|Jet Ventilation|Patients are randomized to receive either jet or conventional ventilation during this study
16030260|NCT02664311|Device|Conventional ventilation|Conventional ventilator - control arm
16030261|NCT02664285|Other|closure of subcutaneous tissue|the subcutaneous fat will be closed with three to five interrupted sutures. The sutures were tied until the tissue was adequately re-approximated, but not as hard as possible to avoid necrosis after cesarean section in diabetic patients.
16030262|NCT02664285|Other|No closure of subcutaneous tissue|the subcutaneous fat will not sutured after cesarean section in diabetic patients.
16030263|NCT02664272|Procedure|Total Hip Arthroplasty|
16030264|NCT02664259|Procedure|VBN|VBN is carried out by a VBN software（DirectPath;Olympus,Japan) which can automatically create virtual bronchoscopic images.
16030265|NCT02664259|Procedure|EBUS|EBUS is performed using an endoscope ultrasound system , which is equipped with a 20-MHz mechanical radial-type probe (UM-S20-17S;Olympus) with an external diameter of 1.4 mm.
16030266|NCT02664259|Procedure|X-ray|The radiograph fluoroscopy is performed when the probe is confirmed to reach the lesion by EBUS image ,cytologic and pathologic specimens are obtained under fluoroscopic guidance.
16030267|NCT02664246|Device|percutaneous coronary intervention|
16030268|NCT02664233|Behavioral|Mobile and connected health|Patients will use a smart phone and a fitness tracker for self-monitoring of diet and physical activity for 3 months; 3) Smart phones will provide feedback with graphical presentation of self-monitored information to patients; 4) Patient self-monitored information will be integrated into Chronicle Diabetes, so that educators will be able to view this information and give feedback in a follow-up visit.
16030269|NCT02664220|Drug|Povidone-iodine irrigation|"Povidone-iodine (PVI) is an antiseptic solution consisting of polyvinylpyrrolidone with water, iodide, and 1% available iodine. It has bactericidal ability against a large array of pathogens, including those pathogens which commonly cause postoperative IAA in children with perforated appendicitis.
~1% PVI will be used. Once the appendix has been removed and hemostasis ensured, the surgeon will perform the irrigation with 10cc/kg (minimum 100ml and maximum 1000ml) of 1% PVI. After completing the irrigation, the surgeon will suction out all intra-abdominal fluid into a suction canister."
16030270|NCT02664220|Procedure|No irrigation|Patients allocated to the control group will not undergo intra-abdominal irrigation.
16030271|NCT02664207|Procedure|Open Fetal Repair of Myelomeningocele|Fetal repair of myelomeningocele in women with additional medical factors that would have excluded them from this treatment under the MOMs trial inclusion/exclusion criteria
16030272|NCT02664194|Device|Proteus® Cooling System|Intravascular hypothermia as an adjunctive method to primary percutaneous coronary intervention, adjunct hypothermia methods and parameters, using Proteus® Cooling System.
16030273|NCT02664194|Procedure|Primary Percutaneous Coronary Intervention|Primary percutaneous coronary intervention
16030274|NCT02664181|Drug|Nivolumab|Nivolumab will be given at 3mg/kg by IV every two weeks until progression
16030275|NCT02664181|Drug|oral decitabine|oral decitabine ~0.2 mg/kg 60 minutes after the THU, twice weekly on consecutive days.
16030276|NCT02664181|Drug|Tetrahydrouridine|Oral THU ~10 mg/kg twice weekly on consecutive days
16030277|NCT02664168|Device|Aquacel Ag Surgical Dressing|
16030278|NCT02664168|Device|Single-Use Negative Pressure Wound Therapy (PICO)|
16030279|NCT02664155|Drug|Apixaban|Direct Oral Anticoagulant
16030280|NCT02664155|Drug|Rivaroxaban|Direct Oral Anticoagulant
16030281|NCT02664155|Drug|Heparin|Standard Of Care
16030282|NCT02664155|Drug|VKA|Standard Of Care
16030283|NCT02664142|Procedure|BIS Group|BIS monitoring will be used in the BIS Group patients. The BIS value will be known to the anaesthetist, who will be able to act accordingly.
16030284|NCT02664142|Procedure|Non-BIS Group|BIS monitoring will be used in the Non-BIS Group patients. The BIS value will NOT be known to the anaesthetist and will be observed by a trained co-investigator, with subsequent evaluation.
16030285|NCT02664142|Drug|Anaesthetics|Anaesthetics will be administered in both experimental groups, in order to maintain the required general anaesthesia.
16030286|NCT02664129|Other|Video self-observation|Patients will watch the video of them in acute decompensation phase then they will be asked about their emotions, their understanding and awareness of mental illness
16030287|NCT02664129|Other|Non Self video observation|Patients will not watch the video of them in acute decompensation phase.
16030288|NCT02664116|Drug|Diclofenac postassium powder for oral solution and placebo injection|Diclofenac postassium powder for oral solution 50 mg in 1 ounce water orally, single dose and placebo normal saline 2ml intramuscular injection, single dose
16030289|NCT02664116|Drug|Ketorolac intramuscular injection and placebo oral solution|ketorolac 60 mg in 2 ml intramuscular injection, single dose and placebo oral solution, 1 ounce, single dose
16030290|NCT02664103|Drug|Fixed-dose combination of capecitabine and cyclophosphamide SAR439281|Pharmaceutical form:Tablet Route of administration: Oral
16030291|NCT02664077|Drug|Regorafenib|3 tablets once a day by mouth for 21 consecutive days of 28 day cycle for 26 cycles
16030292|NCT02664077|Drug|Placebo|3 tablets once a day by mouth for 21 consecutive days of 28 day cycle for 26 cycles
16030293|NCT02664064|Behavioral|Prevent|Intensive behavioral counseling for diabetes prevention and healthy lifestyle management. Recipients have access to online curriculum, a live health coach, group-based communication forums, and connected technology to track weight and physical activity.
16030294|NCT02664051|Drug|Nalcrom|"Drug: disodium cromoglycate 100mg 4x2 daily
~Other Names:
~• Nalcrom"
16030295|NCT02664051|Drug|placebo|100mg 4x2 daily mannitol
16030296|NCT02664038|Behavioral|Cognitive Remediation Training|Up to 65 hours of computer based cognitive training of attention, verbal and visual memory, verbal and visual working memory, and executive functions
16030297|NCT02664025|Procedure|vaginal examination simulator|
16031329|NCT02656914|Drug|Placebo|Take 10 mL every 12 hours (2x/day), oral route.
16030298|NCT02664012|Other|Own Brand Menthol Cigarette|combustible menthol cigarette brand style smoked most frequently by subject
16030299|NCT02664012|Other|Electronic Menthol Cigarette #1|VUSE® Digital Vapor Cigarette (menthol flavor, 14 mg nicotine)
16030300|NCT02664012|Other|Electronic Menthol Cigarette #2|VUSE® Digital Vapor Cigarette (menthol flavor, 29 mg nicotine)
16030301|NCT02664012|Other|Electronic Menthol Cigarette #3|VUSE® Digital Vapor Cigarette (menthol flavor, 36 mg nicotine)
16030302|NCT02664012|Other|Leading U.S. Nicotine Gum|4 mg nicotine polacrilex gum
16030303|NCT02663999|Drug|diazepam nasal spray|diazepam nasal spray at two dose levels (DL). One dose of diazepam nasal spray is administered as two intranasal sprays; one in each nostril using a nasal spray device.
16030304|NCT02663986|Behavioral|Organizational Skills Training (OST) Intervention|
16030305|NCT02663960|Other|fixed citrate doses protocol|fixed doses of anticoagulant citrate dextrose solution to meet a circuit citrate concentration of 4 mmol/l.
16030306|NCT02663960|Other|adjusted citrate doses protocol|the starting infusion rate of anticoagulant citrate dextrose solution be set 2.5 % of blood flow and then be adjusted to obtain postfilter ionized calcium levels of less than 0.40 mmol/l.
16030307|NCT02663947|Device|ultrasonographic measurement of optic nerve sheath diameter|A thick layer of gel is applied on the upper closed eyelid. The linear 7.5-MHz ultrasound probe is then placed in the gel, without exerting pressure on the eye. Three measurements are taken for each optic nerve in the transverse plane, with the probe being horizontal. The final ONSD is the mean of these measurements.
16030308|NCT02663934|Behavioral|Exercise|The resistance exercise training component will follow aerobic exercise and will consist of 4 upper and 3 lower body routines. A combination of guided-motion machines and free weights will be used. Voluntary maximum strength will be measured during the first 4 sessions on each exercise station. The program will initially consist of 1-2 sets of each exercise while lifting a weight that causes muscle fatigue after 8-10 repetitions. The trainer will monitor each participant's exercise response, and when the participant can comfortably lift the weight for 12 repetitions on any exercise, the weight will be increased to cause the muscle group to fatigue after 8 repetitions. This progressive 8-12 repetition cycle is repeated for each exercise over 26 weeks.
16030309|NCT02663934|Behavioral|Stretching and Social Interaction|Participants will receive instructions on stretching, range of motion, limbering, and toning. Activities will focus on flexibility enhancement. Along with the stretching and flexibility, this group will have a social interaction component. They will have discussions and interact with trainers and coordinators during all their sessions. These participants will be supervised by the same trainer and will receive the same amount of attention and class interaction as participants in the EXS program.
16030310|NCT02663921|Other|Part A: Baseline-Week 2|"The study doctor will shine 2 different light bulbs (one a regular or incandescent bulb and the other an LED light bulb) on 12 different areas of patients skin approximately 6 square centimeters in size (less than 1 square inch or the size of your thumb nail). Each light bulb will be exposed to your skin for approximately 20 - 35 minutes. After exposure, the study doctor will perform skin assessments at 3 time points:
~Immediately after the light exposure;
~30 minutes after light exposure; and
~1 hour after light exposure."
16030311|NCT02663921|Other|Part B: Week 4-Week 12|"The study doctor will perform the same 4 skin assessments used in Part A at each visit to assess potential changes in your skin: Digital Photography
~Visual Clinical Assessment
~Spectroscopy
~Colorimetry"
16030314|NCT02663895|Drug|Oral treprostinil|Treprostinil 0.125 mg TID orally, which will be increased by 0.125 mg TID every 3 to 4 days as tolerated
16030315|NCT02663882|Behavioral|self control practice - smoking related task|participants will be asked to practice a smoking-related self control task for 7 days: they will be asked to resist smoking when they have cravings as much as possible during the day
16030316|NCT02663882|Behavioral|self control practice - non-smoking related task|participants will be asked to practice a non-smoking-related self control task for 7 days: they will be asked to keep a straight posture as much as possible during the day
16030317|NCT02663856|Other|observational|Self assessment of ageing transition using a frailty index through MySAwH app
16030318|NCT02663843|Device|i-gel airway|Fibreoptic intubation via i-gel airway device
16030319|NCT02663843|Device|air-Q airway|Fibreoptic intubation via air-Q airway device
16030320|NCT02663830|Drug|Sildenafil & clomiphene citrate|105 Patients will receive 25 mg sildenafil citrate 6hourly orally (day 6 to the end of the cycle), and clomiphene citrate 100 mg/day (day 2 to 6) orally by the patient, for induction of ovulation
16030321|NCT02663830|Drug|clomiphene only|105 Patients will receive clomiphene citrate 100 mg/day (day 2 to 6) orally by the patient, for induction of ovulation
16030322|NCT02663817|Device|CT Scan|
16030323|NCT02663804|Device|Total Knee Arthroplasty|
16030324|NCT02663778|Behavioral|Strength training|weight lifting to increase muscle strength
16030325|NCT02663778|Behavioral|Endurance training|treadmill walking to increase endurance
16030326|NCT02663778|Behavioral|Flexibility training|stretches to improve flexibility
16030327|NCT02663778|Behavioral|Task Specific timing and coordination training|stepping and walking patterns to improve timing and coordination of gait
16030328|NCT02663778|Behavioral|Physical activity behavioral intervention|Intervention to encourage participants to be more physically active
16030329|NCT02663752|Procedure|Bone marrow aspirate|Patients experiencing a hematological response and patients not experiencing a hematological response while on deferasirox treatment received a new bone marrow aspirate in order to investigate the presence of differential gene expression between those two groups
16030330|NCT02663752|Drug|Deferasirox|Patients are already on commercial deferasirox before entering the study.
16030331|NCT02663739|Device|Zenith® TXD|Zenith® TXD Dissection Stent Graft System for treatment of patients with aortic dissection of the descending thoracic aorta
16030332|NCT02663726|Other|Yoga|10 weekly 75-min sessions of specialised yoga
16030333|NCT02663726|Behavioral|Written advice|Written advice about physical activity
16030334|NCT02663713|Drug|Ticagrelor|Ticagrelor 60mg twice daily
16030335|NCT02663713|Drug|Clopidogrel|Clopidogrel 75 mg once daily
16030336|NCT02663700|Drug|Artesunate|Four tablets of 50mg each, totaling 200mg will be given in a single calendar day
16136660|NCT01884558|Drug|metformin|oral
16030337|NCT02663700|Biological|PfSPZ Vaccine|PfSPZ is a candidate vaccine, it consists of a suspension of purified, live-attenuated cryopreserved Pf sporozoites in a cryoprotectant.
16030338|NCT02663700|Other|Placebo|Placebo
16030339|NCT02663687|Drug|Recombinant human C1 esterase inhibitor|Subjects will receive escalating doses I-IV as both IV and SC injections
16030340|NCT02663687|Drug|Placebo|Subjects will receive matching placebo
16030341|NCT02663687|Drug|SHP623|SHP623
16030342|NCT02663687|Drug|Placebo|Placebo
16030343|NCT02663674|Drug|Fluconazole|Fluconazole is a synthetic triazole antifungal agent. It will be supplied as 200 mg over encapsulated tablets. Each gelatin capsule will contain two-100 mg fluconazole tablets and microcrystalline cellulose for overfill.
16030344|NCT02663674|Other|Placebo|Placebo will be supplied as matching gelatin capsules containing microcrystalline cellulose only. Capsules are the same size, weight, and color as capsules containing fluconazole tablets.
16030345|NCT02663661|Procedure|Metabolic Challenge Admission|A ten hour clinical test involving drinking a liquid mixed meal followed four hours later by the induction of hypoglycemia with intravenous insulin administration.
16030346|NCT02663661|Other|CGM home test|A home study starting immediately after the clinical test during which participants will wear a continuous glucose monitor (CGM) for one week.
16030347|NCT02663635|Device|Safe'N'Sound|
16030348|NCT02663622|Drug|CD24Fc|Acute GVHD prophylaxis
16030349|NCT02663622|Drug|Methotrexate|Acute GVHD prophylaxis
16030350|NCT02663622|Drug|Tacrolimus|Acute GVHD prophylaxis
16030351|NCT02663622|Drug|Placebo|100 ml saline IV infusion.
16030352|NCT02663609|Other|No intervention|No treatment (intervention) was administered.
16030353|NCT02663596|Drug|Vancomycin|Patient requiring CRRT and vancomycin that provide consent will be given vancomycin as a continuous infusion by mixing the vancomycin into the CRRT solution(s)
16030354|NCT02663583|Behavioral|Symptom Questionnaires|"Intensity-Modulated Proton Therapy or( IMPT) Group: Symptom questionnaires about symptoms of cancer and how they affect life at work and at home, diet, and speech completed at baseline, every week during IMPT, at 3 months, and at 6 months.
~TransOral Robotic Surgery (TORS) Group: Symptom questionnaires about symptoms of cancer and how they affect life at work and at home, diet, and speech completed at baseline, after TORS, at 3 months, and at 6 months."
16030355|NCT02663583|Behavioral|Dysphagia Inventory Questionnaire|"Intensity-Modulated Proton Therapy or( IMPT) Group: Dysphagia Inventory questionnaire about how difficult it is to swallow completed at baseline, every week during IMPT, at 3 months, and at 6 months.
~TransOral Robotic Surgery (TORS) Group: Dysphagia Inventory questionnaire about how difficult it is to swallow completed at baseline, after TORS, at 3 months, and at 6 months."
16030356|NCT02663583|Behavioral|Activity Bands|Activity bands given to participant at baseline. Participant wears the band 24 hours a day for 1 week leading up to all study visits.
16030357|NCT02663570|Drug|Melatonin|
16030358|NCT02663544|Other|Limited dairy diet|Consumption of no dairy foods other than 3 servings per week of nonfat milk for 12 weeks
16030359|NCT02663544|Other|Low-fat dairy diet|Consumption of 3.3 servings per day of low-fat milk, yogurt, and cheese for 12 weeks
16030360|NCT02663544|Other|Full-fat dairy diet|Consumption of 3.3 servings per day of full-fat milk, yogurt, and cheese for 12 weeks
16030361|NCT02663531|Device|DVA|
16030362|NCT02663531|Device|FDOCT|
16030363|NCT02663531|Device|Pattern ERG|
16030364|NCT02663531|Device|Optical Coherence Tomography|
16030365|NCT02663518|Drug|TTI-621|Monotherapy
16030366|NCT02663518|Drug|TTI-621 plus Rituximab|Combination therapy
16030367|NCT02663518|Drug|TTI-621 plus Nivolumab|Combination therapy
16030368|NCT02663505|Procedure|Patients receiving the surgery planned for them|"For each patient the following potential influence (risk) factors are documented:
~sex, urgency of the operation, BMI, age, ASA classification, preconditions, physical fitness, Hb value.
~In phase 2 only selected influence factors will be recorded.
~No intervention will be performed apart from the surgery planned for each patient."
16030369|NCT02663492|Device|TEAS|The patients will be treated by their assigned acupuncture stimulation in 7 days. The surface electrical stimulation devices and application parameter are: G6805-II pulse acupuncture treatment instrument from Shanghai Medical Technology Company, Ltd (Shanghai, China); sparse-dense wave stimulation (sparse wave 30Hz; dense wave 100Hz) with an intensity of 6-15 V; and the corresponding parts of the body experienced a slight quiver, with a duration 20 minutes each time.
16030370|NCT02663492|Drug|Sanguisorba officinalis L.|Sanguisorba officinalis L., a Leukogenic medication, named Diyu Shengbai Pian (Chengdu Diao Tianfu Pharmaceutical Group Co., Ltd., China) will be taken 0.4g each time by 3 times per day.
16030371|NCT02663479|Dietary Supplement|Cardiopressin|
16030372|NCT02663479|Dietary Supplement|Placebo|
16030373|NCT02663466|Procedure|erroneous off-midline closures|All patients with pilonidal sinus recurrent disease following Limberg flap reconstruction in the recurrent group were examined by the authors in each study center and high resolution close-up photos of the patients' sacrococcygeal area were taken. These photos were then sent to all authors to asses and reach a collective decision to classify the erroneous off-midline closure technique and precisely measuring the distance between the flap border and the midline in the cleft. Same evaluation method was applied to the patients in nonrecurrent group. Following the completion of the assessments, all digital data of the patients were permanently deleted.
16030374|NCT02663453|Drug|multicomponent lipid emulsion|Lipids were first administered at a dose of 1gm/kg/day within 24 hours after birth for both groups; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.
16030375|NCT02663453|Drug|pure soybean oil lipid emulsion|Lipids were first administered at a dose of 1gm/kg/day within 24 hours after birth for both groups; lipid dosage was increased by an increment of 0.5 gm/kg/day until the maximal dose of 3.5 gm/kg/day was reached.
16030376|NCT02663440|Radiation|Hypofractionated IMRT|Hypofractionated IMRT
16030377|NCT02663440|Biological|Granulocyte-macrophage Colony-stimulating Factor|Granulocyte-macrophage Colony-stimulating Factor
16030378|NCT02663440|Drug|Temozolomide|Temozolomide
16030379|NCT02663427|Device|serological examination and gastroscope|
16030681|NCT02661126|Drug|MK-3682B|FDC oral tablet containing 225 mg uprifosbuvir + 50 mg grazoprevir + 30 mg ruzasvir.
16031592|NCT02655120|Biological|Bone Marrow +BMP7|
16030380|NCT02663414|Device|Atlas Knee System|The Atlas Knee System is an approved device (CE Marked) and is an extra-capsular knee implant specifically designed to treat patients with uni-compartmental, medial knee osteoarthritis (OA).
16030381|NCT02663401|Behavioral|Front-of-pack labelling 5-CNL|Introduction of the 5-CNL Front-of-pack nutrition label on shelf display tags for every food and beverage sold in the cafeteria
16030382|NCT02663388|Procedure|gastric bypass, sleeve, gastric banding|
16030383|NCT02663375|Device|ACURATE TA™ Transapical Aortic Bioprosthesis|ACURATE TA™ Transapical Aortic Bioprosthesis is intended for subjects with severe symptomatic aortic stenosis and are considered high risk for surgical conventional Aortic Valve Replacement.
16030384|NCT02663362|Other|To evaluate the reproducibility of acquiring multi-nuclear data on a new 3T Philips Magnet|Outside standard MR instrumentation there will be no interventions.
16030385|NCT02663349|Behavioral|Social Cognition and Intervention Training|A manualized group therapy that teaches social cognitive skills.
16030387|NCT02663323|Device|MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System|MeRes100 Sirolimus Eluting Bioresorbable Vascular Scaffold System in the treatment of de-novo coronary artery lesions.
16030388|NCT02663310|Procedure|Surgery|Surgery treatment of the injured vertebra(e), internal fixation of the vertebral column, and bilateral laminectomy for epidural decompression were followed directly by neurosurgical management, including separation of the arachnoid adhesion to restore cerebrospinal fluid flow and debridement of the spinal cord necrotic tissue with concomitant intramedullary decompression.
16030389|NCT02663310|Procedure|Rehabilitation|The patients need to do intensive rehabilitation everyday. （1）The limb comprehensive training is Kunming Locomotor exercise, 60 minutes twice per day.(2)The exercise therapy includes sit-ups by 30 times, twice per day; half bridge exercise by 10 times, twice per day; backward flight movement by 10 times, twice per day; sling exercise training by 30 minutes, twice per day; and postural transfer functional training by 10 minutes, twice per day. (3)The balance training include ball toss training by 10 minutes, twice per day; and balance board training by 10 minutes, twice per day. (4)The wheelchair training will be taken 20 minutes each, twice per day. (5)The isokinetic training needs to perform 20 minutes each, twice per day.
16030390|NCT02663297|Drug|ATLCAR.CD30 cells|"Three dose levels will be evaluated:
~Group One, 2x10^7 cells/m^2 (maximum dose 5x10^7 cells)
~Group Two, 1x10^8 cells/m^2 (maximum dose 2.5x10^8 cells)
~Group Three, 2x10^8 cells/m^2 (maximum dose 5x10^8 cells)"
16030391|NCT02663284|Drug|Ropivacaine 0.5%|Ropivacaine is used to performed the perineural block
16030392|NCT02663271|Drug|Bevacizumab|Bevacizumab will be given at 10mg/kg IV every 2 weeks.
16030393|NCT02663271|Device|Optune|Optune will be worn continuously for 12 months. Optune is programmed by Novocure to deliver 200 kHz TTFields in two sequential, perpendicular field directions at a maximal intensity of 707mARMS. There will be no adjustments made to the device by investigators or patients/caregivers.
16030394|NCT02663271|Other|Brain MRI|Brain MRI will be done at screening and every 8 weeks.
16030395|NCT02663271|Other|Quality of Life Questionnaires|The quality of life questionnaires will be performed within 14 days of treatment and every 4 weeks.
16030396|NCT02663258|Drug|Pembrolizumab|
16030397|NCT02663245|Other|Intervention 1|"Diabetes specific consultation
~Basic training in clinical guidelines
~Platform of communication for professionals
~Training update to review and evaluate actual cases where the coaching strategy has been applied 2-hours training programme to update and review the training of month 0.
~7-hour training programme in group coaching for primary care professionals with a theoretical and practical approach.
~Intervention based on text messaging to patients to remind them of strategies that promote behaviour change in relation to diabetes."
16030398|NCT02663245|Other|Intervention 2|"7-hour training programme in group coaching for primary care professionals with a theoretical and practical approach.
~Training update to review and evaluate actual cases where the coaching strategy has been applied 2-hour training programme to update and review the training of month 0.
~Basic training in clinical guidelines.
~Platform of communication for professionals.
~Intervention based on text messaging to patients to remind them of strategies that promote behaviour change in relation to diabetes."
16030399|NCT02663219|Behavioral|Intervention|The intervention arm will provide a Case Manager (CM) intervention package designed to enhance linkage to care, antiretroviral treatment (ART) initiation, treatment adherence and retention in care.
16030400|NCT02663206|Procedure|peroral endoscopic myotomy|peroral endoscopic myotomy
16030401|NCT02663206|Procedure|Botulinum toxin injection|endoscopic Botulinum toxin (BTX) injection at lower esophagus
16030402|NCT02663193|Other|No Intervention|Participants who are receiving enzalutamide or abiraterone acetate in combination with prednisone in a clinical practice setting will be observed for tolerability and quality of life.
16030403|NCT02663180|Behavioral|Educational program|Educational strategies: 2 Lecture about depression 30 minutes supported by group discussion, brochures and display of posters with mental-health slogans on depression in the schools.
16030404|NCT02663180|Behavioral|Video contact|Contact strategies: Investigators will show a video of a young male who had been diagnosed with depression. The video presented information that was moderately disconfirming of prior stereotypes by balancing the individual's difficulties resulting from Depression, with his ability to live a normal life.
16030405|NCT02663167|Behavioral|Internet-delivered Cognitive Behavioral Therapy|The treatment consists of a standard cognitive behavioral therapy for obsessive-compulsive disorder. The treatment is delivered through an Internet platform. The child and his/her parent(s) work through the treatment with regular therapist contact several times per week.
16030406|NCT02663154|Drug|Aromatherapy inhaler|Inhalation of commercial essential oil preparation (QueaseEASE) delivered in the commercial inhaler package in postanesthetic care unit after surgery in paediatric patients complaining of nausea
16030407|NCT02663154|Drug|Saline inhaler|Inhaler is similar in design and function as the intervention inhaler only with saline rather than essential oils. Inhaler provided by the manufacturer QueaseEASE (Soothing Scents, Inc, Enterprise, AL)
16030408|NCT02663141|Drug|Losartan|
16030409|NCT02663141|Drug|Intravitreal bevacizumab|
16030410|NCT02663141|Drug|Placebo|
16030411|NCT02663128|Drug|Lanabecestat|Administered orally
16030412|NCT02663115|Other|Biopsy of the diaphragmatic muscle|
16030413|NCT02663115|Other|Skeletal muscle biopsy|
16030414|NCT02663102|Other|Data collection|Safety monitoring and evaluation: - Recording of all AEs during the study period using diary cards, follow-up contact via telephone or email. - Recording of SAEs throughout the study period for each subject.
16030415|NCT02663089|Drug|[14C]-GSK961081 solution for IV infusion|Subjects will receive 10 mL of solution equivalent to 4 mcg of [14C]-GSK961081 (approximately 6.2 kilobecquerel [kBq]) intravenously as a single dose over 1 hour.
16030416|NCT02663089|Drug|[14C]-GSK961081 oral solution|Subjects will receive 10 mL of solution equivalent to 200 mcg of [14C]-GSK961081 (approximately 311 kBq) orally as a single dose with up to 250 mL of water.
16030417|NCT02663089|Drug|GSK961081 dry powder for inhalation|Subjects will receive single dose of 4 actuations of 300 mcg GSK961081 per actuation (1200 mcg GSK961081 total) as inhalation immediately after the start of infusion.
16030418|NCT02663063|Device|SSP treatment|SSP treatment 5 times a week
16030419|NCT02663050|Other|Kinesio taping|Patients will be taped for four days , ıt will start at the begining of the Dysmenorrhea
16030420|NCT02663050|Drug|NSAID's|twice a daily
16030421|NCT02663024|Biological|idursulfase beta|IV, weekly infusion for 24 weeks
16030422|NCT02663024|Biological|idursulfase|0.5 mg/kg, iv, weekly infusion for 24 weeks
16030423|NCT02663011|Other|Language Evaluation-Preschool Language Scale Corrected edition(PLS-C), Lin|"To assess age and gender effect in the language error type (semantics, syntax and pragmatics)of developmental delay preschool aged children, a standardize tool Preschool Language Scale Corrected edition(PLS-C), Lin was adopted for evaluation."
16030424|NCT02662985|Drug|AIN457 (secukinumab)|"Is a recombinant monoclonal antibody which neutralizes the activity of IL-17A, and has been shown to be effective in treating patients with moderate-to-severe plaque psoriasis.
~Secukinumab 150 mg provided in 1 mL pre filled syringes (PFS) for s.c. injection. The 300 mg dose will be administered as 2 × PFS injections."
16030425|NCT02662985|Drug|Placebo|Secukinumab placebo provided in a 1 mL PFS for s.c. injection.
16030426|NCT02662972|Drug|Botulinum Toxin Type A|
16030427|NCT02662959|Drug|Irinotecan|180 mg/m2, IV (in the vein) on day 1 of each 14 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
16030428|NCT02662946|Procedure|ICG- angiography|Angiography with ICG prior to and after anastomosis. Extension of colon resection based on ICG angiography results
16030429|NCT02662946|Procedure|No angiography|Extension of resection based on subjective measures
16030430|NCT02662933|Other|Bedside assessment|"The study intervention consists of a bedside functional assessment to be administered to eligible, consented subjects who are hospitalized with a new diagnosis of AML or are undergoing workup for suspected AML diagnosis. All subjects will be enrolled within 5 days of admission to the hospital for known or suspected AML or within 5 days of new confirmed diagnosis of AML obtained during a hospitalization for other indications. All measures will be performed by a trained examiner during a face to face interview.
~Bedside assessment measures will be repeated once for subjects who complete induction chemotherapy within 2-8 weeks post discharge from initial hospitalization."
16030431|NCT02662920|Other|No Intervention|
16030432|NCT02662907|Procedure|Barium Swallow|Participants receive modified barium swallow at baseline and after 8 weeks of using the EMST device
16030433|NCT02662907|Behavioral|Questionnaires|Questionnaires completed about symptoms and quality of life at baseline, after 8 weeks of using the EMST device, and 12 months after completing the study.
16030434|NCT02662907|Device|Expiratory Muscle Strength Training (EMST) Device|Participant uses the EMST device at home on a 5-5-5 schedule (5 repetitions, 5 sets, 5 days per week) for 8 weeks.
16030435|NCT02662907|Device|Digital Manometer|Digital manometer used to test how forcefully participant is able to exhale and cough at baseline, and one time each week for 8 weeks while using the EMST device.
16030436|NCT02662907|Behavioral|Neurocognitive Exams|Participants given neurocognitive exams at baseline.
16030437|NCT02662907|Drug|Barium|Participants receive barium prior to modified barium swallow at baseline and after 8 weeks of using the EMST device.
16030438|NCT02662894|Drug|Valsartan 160mg + Rosuvastatin 20mg|1 tablet, oral, a day
16030439|NCT02662894|Drug|Valsartan 320mg + Rosuvastatin 20mg|1 tablet, oral, a day
16030440|NCT02662894|Drug|Diovan® 160mg + Crestor® 20mg|Take together 1 tablet of Diovan (160mg) plus 1 tablet of Crestor (20mg), oral, once daily.
16030441|NCT02662894|Drug|Diovan® 320mg + Crestor® 20mg|Take together 1 tablet of Diovan (320mg) plus 1 tablet of Crestor (20mg), oral, once daily.
16030444|NCT02662855|Other|WHO-recommended therapies|symptomatic and supportive treatments according to the WHO manual
16030445|NCT02662855|Drug|Favipiravir|oral administration of Favipiravir tablets
16030446|NCT02662842|Device|FlowSmart Infusion Set|Use of set for subcutaneous insulin infusion, with set change every three days.
16030447|NCT02662842|Device|Current Infusion Set|Use of set for subcutaneous insulin infusion, with set change every three days.
16030448|NCT02662829|Behavioral|Community-based intervention|
16030449|NCT02662829|Other|Standard of care|
16030450|NCT02662816|Device|Proton magnetic resonance spectroscopy (1H MRS)|
16030451|NCT02662816|Other|a protein rich breakfast at home|
16030452|NCT02662816|Other|a protein rich lunch at the Clinical Investigation Center|
16030453|NCT02662803|Other|high-intensive aerobe exercise|Aerobe bicycle ergometer training within 77-95% of maximum oxygen consumption; duration of each training session: 20 minutes; frequency of training: 6 sessions within 12 days
16030454|NCT02662803|Other|low-intensive aerobe exercise|Aerobe training below 70% of maximum oxygen consumption (including light stretching and simple exercises adapted from yoga figures); duration of training session: 20 minutes; frequency of training: 6 sessions within 12 days
16030455|NCT02662790|Other|Doppler|
16030456|NCT02662777|Device|Eso-SPONGE® vacuum treatment|
16030457|NCT02662764|Drug|Zalviso™ 15 mcg|Zalviso™ (sufentanil sublingual tablet system) 15 mcg. Tablets to be self-administered by the patient as needed for pain, no more than every 20 minutes, for 24 hours and up to 72 hours
16030682|NCT02661100|Drug|Pembrolizumab|200mg/kg by IV infusion on Day 1 of each 3 week cycle. Given until disease progression
16030458|NCT02662751|Other|Routine Imaging Assessment|"Patients will have the usual post-stroke/TIA imaging assessment according to routine procedures in each participating center. The latter most often begin with an angiography of the supra-aortic trunks but may also include a range of other imaging exams depending on the patient's condition.
~Routine Imaging Assessment refers to an imaging strategy and not a specific device. The devices used depend on what is available in participating centres and the routine choices made by those centers."
16030459|NCT02662751|Device|LDWBA first (CT scan)|"Patients randomized to this arm will start their post-stroke/TIA imaging assessment by a low-dose, whole-body angiography (LDWBA). The latter can be followed by routine imaging assessments if required.
~LDWBA: This is a low dose scanner protocol comprising a CT acquisition and an iodine contrast medium injection. The acquisition includes a propeller during the arterial phase of the contrast agent injection in the cervical and thoracic levels with cardiac gaiting (ECG gating to reduce cardiac motion artifacts), continuing with pelvic abdominal arterial acquisition. The second propeller is made on the abdomen and pelvis at the portal time of injection. The reconstruction will be carried out in pulmonary, mediastinal and bone windows. The dose will be calculated for each patient."
16030460|NCT02662738|Dietary Supplement|Natural fruit extract|
16030461|NCT02662738|Other|Placebo|
16030462|NCT02662738|Other|Glucose solution|
16030463|NCT02662725|Drug|IPILIMUMAB|
16030464|NCT02662725|Radiation|Stereotactic radiosurgery|
16030465|NCT02662712|Drug|JNJ-56136379|JNJ-56136379 oral tablets will be given in Part 1 (single dose escalation and multiple dose session) and Part 2 (multiple dose escalation).
16030466|NCT02662712|Drug|Placebo|Matching placebo to JNJ-56136379 will be given in Part 1 (single dose escalation and multiple dose session) and Part 2 (multiple dose escalation).
16030467|NCT02662686|Other|Transfer according to morphological criteria|Embryos will be analyzed by PGS and mitochondrial score on day 3 or day 5/6 biopsy and transferred on day 5/6, according to morphological criteria (control group).
16030468|NCT02662686|Other|Transfer according to the MitoScore results|Embryos will be analyzed by PGS and mitochondrial score on day 3 or day 5/6 biopsy and transferred on day 5/6, according to the MitoScore results (experimental group).
16030469|NCT02662673|Device|Focal High Intensity Focused Ultrasound (HIFU) treatment|Focal High Intensity Focused Ultrasound (HIFU) treatment for localized prostate cancer (maximum two foci). HIFU treatment is using high energy ultrasound focused at the focal point to achieve precise tissue destruction. This mini-invasive therapy is using an endo-rectal approach to deliver the treatment, using a probe composed of a combined imaging and treatment transducer. The treatment is monitored by real-time ultrasound. The treatment planning is performed by the urologist, contouring the area to be treated (MRI target + security margins around the tumor) and the treatment phase is automatically performed by the robotic device.
16030470|NCT02662660|Drug|Port-sites infiltration:Bupivacaine0.25%|Port-sites infiltration will be performed with 10 ml of Bupivacaine 0.25%, applying 2 ml under the aponeurotic layer in each port.
16030471|NCT02662660|Drug|Epidural analgesia:Levobupivacaine0,125%|Port-sites infiltration will be performed with 10 ml of Bupivacaine 0.25%, applying 2 ml under the aponeurotic layer in each port.
16030472|NCT02662660|Drug|Metamizole and Acetaminophen iv|Associated Intravenous analgesia include Metamizole 2g/8h and Acetaminophen 1g/8h, alternating every 4 hours.
16030473|NCT02662647|Drug|Decitabine 20 mg/m²/day for 5 days|
16030474|NCT02662634|Biological|AGS-003-LNG|autologous dendritic cell immunotherapy
16030475|NCT02662634|Drug|Carboplatin|"Carboplatin is an anticancer drug (antineoplastic or cytotoxic) chemotherapy drug. Carboplatin is classified as an alkylating agent."
16030476|NCT02662634|Drug|Abraxane|Paclitaxel destroys cancer cells by preventing the normal breakdown of microtubules during cell division.
16030477|NCT02662634|Drug|Alimta|By inhibiting the formation of precursor purine and pyrimidine nucleotides, pemetrexed prevents the formation of DNA and RNA, which are required for the growth and survival of both normal cells and cancer cell
16030478|NCT02662634|Drug|Cisplatin|Binds to and causes crosslinking of DNA, which ultimately triggers apoptosis
16030479|NCT02662634|Drug|Taxol|Mechanism of action involves interference with the normal breakdown of microtubules during cell division.
16030480|NCT02662634|Radiation|Radiation Therapy|Causes DNA strand breaks.
16030481|NCT02662621|Other|blood samples|
16030482|NCT02662621|Other|Urine samples|
16030483|NCT02662608|Drug|Brontictuzumab|1.5 mg/Kg intravenously every three weeks.
16030484|NCT02662595|Other|SMS reminder message|
16030485|NCT02662595|Other|Voice call + SMS message|
16030486|NCT02662582|Drug|Reldesemtiv|Oral tablet
16030487|NCT02662582|Drug|Placebo|Oral tablet
16030488|NCT02662569|Biological|Evolocumab|Administered by subcutaneous injection
16030489|NCT02662569|Drug|Atorvastatin|Administered orally once a day
16030490|NCT02662569|Other|Placebo|Placebo to evolocumab administered by subcutaneous injection
16030491|NCT02662556|Drug|sufentanil sublingual tablet 30 mcg|sufentanil sublingual tablet 30 mcg as needed for pain management, but no more frequently than every 60 minutes, for up to 12 hours.
16030492|NCT02662530|Drug|Botulinum Toxin Type A|A serotype of botulinum toxin type A (BoNT-A) that has specificity for cleavage of SYNAPTOSOMAL-ASSOCIATED PROTEIN 25 (SNAP-25). BoNT-A's pharmacological action is to inhibit the release of acetylcholine from the neuromuscular junction. BoNT-A peripherally applied using optimal parameters by intramuscular injections solely determined either by visual/clinical or by biomechanical analysis of dystonic movements for cervical dystonia therapy in neck and shoulder muscles every 12 weeks over 30 weeks. BoNT-A dose will range from 50-300 U.
16030493|NCT02662504|Device|photodynamic therapy (PDT)|"Intra-operative (intrapleural) photodynamic therapy (PDT): briefly, each patient will receive porfimer sodium (PHOTOFRIN®) (2 mg/kg) 24 hours before eP/D (IV injection on 3-5 minutes). Cutaneous light precautions will be instituted immediately and for the next 4 weeks.
~After complete macroscopic resection of the tumour, the thoracic surgeon and his team will set isoprobes (7 at least) in the pleural cavity to monitor by a dosimetry device the correct illumination of the cavity with a visible red light (wavelength of 630 nm; laser source). PDT-related postoperative considerations include light precautions, intensive focus on perioperative nutrition, and a greater than normal fluid requirement in the immediate postoperative period."
16030683|NCT02661100|Biological|CDX-1401|1mg given subcutaneously on day 1 of each 3 week cycle. Given for 4 cycles
16030494|NCT02662504|Procedure|thoracic surgery Pleurectomy / extended Decortication|extended P/D is intended to remove any macroscopic tumor including the parietal and visceral pleura when the diaphragm and / or the pericardium was resected
16030495|NCT02662504|Drug|Adjuvant chemotherapy|Chemotherapy should begin up to three months after surgery. It consists of pemetrexed 500 mg / m2 followed 30 minutes later by cisplatin 75 mg / m2 (in the usual manner from the center to the chemotherapy) on day 1 (J1) of each cycle every 3 weeks, for up to 6 cycles.
16030496|NCT02662491|Dietary Supplement|Vitamin D and calcium|
16030497|NCT02662491|Dietary Supplement|Vitamin D|
16030498|NCT02662491|Dietary Supplement|Calcium|
16030499|NCT02662491|Dietary Supplement|Placebo|
16030500|NCT02662478|Procedure|Laparoscopic Surgery|Mid-point between the xiphoid and umbilicus was used to the entrance site of the telescope. Open trocar insertion was used in patients with history of open upper abdominal surgery; otherwise Veress needle established CO2 insufflations. The number, size and entry points of the other trocars were tailored according to the tumor location and size. In general, 2 to 4 additional trocars were used. All specimens were taken out of the abdomen through a suprapubic transverse incision in a sterile bag. Resection technique was determined by the size, number, location of the lesion, and surgical anatomy of the stomach. Lymph node dissection was not done as it is unnecessary.
16030501|NCT02662465|Procedure|Laser|Patients who develop oral mucositis even after the prevention, will be divided into three groups for laser sessions with the purpose of treatment of oral mucositis. The group assignment obeyed severity of oral mucositis.
16030502|NCT02662452|Drug|GLPG2222 single dose|single ascending doses, oral suspension
16030503|NCT02662452|Drug|Placebo single dose|single doses, oral suspension, matching placebo
16030504|NCT02662452|Drug|GLPG2222 multiple doses|multiple ascending doses, daily for 14 days, oral suspension
16030505|NCT02662452|Drug|Placebo multiple doses|multiple doses, daily for 14 days, oral suspension, matching placebo
16030506|NCT02662439|Device|Body Composition Monitor (BCM)|In the experimental group, the diuretic therapy adjusted according to the result of the BCM analysis.
16030507|NCT02662426|Drug|Lingdancao granules|4 packs per time (3g/pack), three times per day
16030508|NCT02662426|Drug|analogous oseltamivir phosphate capsule|1 capsule per time, twice per day
16030509|NCT02662426|Drug|Oseltamivir phosphate capsule|1 capsule per time (75mg), twice per day
16030510|NCT02662426|Drug|analogous Lingdancao granules|4 packs per time, three times per day
16030511|NCT02662413|Other|Validation of Asthma Control Questionnaire|This is an observational study so there is no planned intervention.
16030512|NCT02662400|Biological|MNCs|200 - 300 ml of bone marrow will be aspirated and layered on density gradient medium (Ficoll - hypaque ) and stem cells will be separated. Separated mono nucleated cells will injected into superior pancreatico duodenal artery. Patients will be urged to monitor and document blood glucose readings for next 6 months. Glucagon stimulated C - peptide HYPERGLYCEMIC CLAMP FOR ASSESSMENT OF BETA CELL FUNCTION , AND EUGLYCEMIC CLAMP TO ASSESS INSULIN SENSITIVITY .Homeostasis Model of Assessment - Insulin Resistance and Beta cell function ,HbA1c, lipid profile and biochemistry will be done at baseline and 6 months
16030513|NCT02662387|Device|External nasal dilator (END)|Applying External nasal dilator as adjuvant to high flow oxygen
16030514|NCT02662387|Other|High flow nasal cannula (HFNC)|Non-invasive positive pressure ventilation
16030515|NCT02662374|Drug|.02% Chlorohexidine Gluconate|5ml of the drug in mouthwash form to be swished four times a day
16030516|NCT02662374|Drug|3% Sodium Bicarbonate|5ml of the drug in the form of a prepared solution to be swished four times a day
16030517|NCT02662374|Drug|Nystatin 10000U/ml|5ml of the drug in mouthwash form to be swished and swallowed four times a day
16030518|NCT02662374|Device|Extra Soft Toothbrush|To be moistened with 0.9% normal Saline and used twice daily to remove dental plaque
16030519|NCT02662374|Drug|Supersaturated Calcium Phosphate|5ml of the solution to be swished four times a day
16030520|NCT02662348|Drug|Recombinant Human Interleukin-2|Given SC
16030521|NCT02662348|Drug|HER2Bi-Armed T Cells|Given IV
16030522|NCT02662335|Other|Computer-Assisted Cognitive Training|Participate in Cogmed computerized working memory training
16030523|NCT02662335|Other|Questionnaire Administration|Ancillary studies
16030524|NCT02662335|Procedure|Standard Follow-Up Care|Undergo standard follow-up care
16030525|NCT02662322|Other|Hypnotic communication|hypnotic communication during peripheral intravenous catheterization
16030526|NCT02662322|Other|negative connotation communication|negative connotation communication during peripheral intravenous catheterization
16030527|NCT02662322|Other|neutral connotation communication|neutral connotation communication during peripheral intravenous catheterization
16030528|NCT02662322|Other|peripheral intravenous catheterization|peripheral intravenous catheterization
16030529|NCT02662309|Drug|MPDL3280A|Intravenous infusion
16030530|NCT02662296|Drug|Ibrutinib|Given PO
16030531|NCT02662296|Drug|Idelalisib|Given PO
16030532|NCT02662283|Drug|Prednisolone|Oral take prednisolone (0.5 mg/kg, qd) for 8 weeks
16030533|NCT02662283|Drug|Reh-acteoside|Oral take and reh-acteoside (0.4g bid) for 8 weeks
16030534|NCT02662257|Drug|Sevoflurane|"Sevoflurane will be administered by inhalation for anesthesia maintenance. The concentration of inhaled sevoflurane will be adjusted to maintain the bispectral index (BIS) value between 40 and 60, with or without 50% nitrous oxide. Analgesia will be supplemented with remifentanil (administered by continuous infusion), sufentanil (administered by intermittent injection/continuous infusion), or fentanyl (administered by intermittent injection).
~Towards the end of surgery, sevoflurane inhalational concentration will be decreased and fentanyl/sufentanil will be administered when necessary. Sevoflurane inhalation will be stopped at the end of surgery."
16030535|NCT02662257|Drug|Propofol|"Propofol will be administered by intravenous infusion for anesthesia maintenance. The infusion rate of propofol will be adjusted to maintain the BIS value between 40 and 60, with or without 50% nitrous oxide. Analgesia will be supplemented with remifentanil (administered by continuous infusion), sufentanil (administered by intermittent injection/continuous infusion), or fentanyl (administered by intermittent injection).
~Towards the end of surgery, propofol infusion rate will be decreased and fentanyl/sufentanil will be administered when necessary. Propofol infusion will be stopped at the end of surgery."
16138095|NCT01873170|Drug|DMPA exposure|
16030537|NCT02662231|Procedure|Emergency, or elective gastrointestinal resection|Gastrointestinal resection is defined as complete transection and removal of a segment of the oesophagus, stomach, small bowel, colon or rectum, including cholecystectomy, and appendicectomy.
16030538|NCT02662205|Other|Psychotherapy Group|Traditional process group
16030539|NCT02662205|Other|Yoga class|Yin yoga class
16030540|NCT02662205|Other|Yoga Therapy Group|Yoga psychotherapy group integrating yoga and process dialogue
16030541|NCT02662192|Other|Exercise + health education+ auditory rehabilitation|comparison of 3/4 of an hour balance, resistance and strength training, 1 hour health education, 1 hour auditory rehabilitation
16030542|NCT02662192|Other|auditory rehabilitation alone|10 weeks of one hour per week of group auditory rehabilitation
16030543|NCT02662179|Other|Quality of life evaluation|Assess the quality of life ('SF-36' questionnaire) of patients 3 and 6 months after oncologic treatment. Since a diagnosis of frailness will have been established before the oncologic treatment, a correlation between the decline and the 'frail' categorization according to the Fried criteria can be established or denied.
16030544|NCT02662179|Other|Functional decline assessment|Assess functional decline ('Katz ADL' Score and 'Lawton IADL' Score) 3 and 6 months after oncologic treatment. Since a diagnosis of frailness will have been established before the oncologic treatment, a correlation between the decline and the 'frail' categorization according to the Fried criteria can be established or denied.
16030545|NCT02662179|Other|Physical decline assessment|Assess physical decline (walking speed and prehension force) 3 and 6 months after oncologic treatment. Since a diagnosis of frailness will have been established before the oncologic treatment, a correlation between the decline and the 'frail' categorization according to the Fried criteria can be established or denied.
16030546|NCT02662179|Other|Cognitive decline assessment|Assess cognitive decline 3 and 6 months ('MMSE 30' questionnaire) after oncologic treatment. Since a diagnosis of frailness will have been established before the oncologic treatment, a correlation between the decline and the 'frail' categorization according to the Fried criteria can be established or denied.
16030547|NCT02662166|Device|MR imaging|3 T MRI of the urinary bladder
16030548|NCT02662153|Other|Observation only|No intervention.
16030549|NCT02662140|Behavioral|Mobile Health Applictaion|"Component 1: Delivering homework via a highly engaging, multiplayer, interactive, cooperative, and skill-building game platform aimed at improving the Design and Do process of HW.
~Component 2: Focuses on targeting factors putative related to poor HW implementation within the Do process"
16030550|NCT02662127|Device|SIGVARIS® Class 2 - RAL: 23-32.|Below knee graduated elastic compression stocking
16030551|NCT02662114|Other|No treatment given|Information will be collected from the medical records (paper/electronic) of each patient at several outpatient clinics to describe the two periods of medical history: before and after the initiation date of Tresiba®. For each patient, data will be collected, to describe a minimum of 6 months to a maximum of 12 months in each period; thus, the study will collect information on 12 to 24 months of medical history for each patient.
16030552|NCT02662101|Device|Exsalt SD7, Exsalt T7 Wound Dressing|
16030553|NCT02662088|Procedure|laparoscopic-lavage|
16030554|NCT02662075|Device|E-cigarette/tobacco Smoking Exposure|Subjects will be asked to smoke an e-cigarette containing the equivalence of nicotine in one tobacco cigarette (15 puffs) in the presence of research staff. Each puff will be timed at 4 seconds and there should be a 20-30 seconds interpuff interval as previously recommended.
16030555|NCT02662062|Drug|Pembrolizumab|200 mg/m2, IV (in the vein) on day 1 every three weeks (Weeks 1, 3, 7, 10, 13, 16 and 19). until progression or unacceptable toxicity develops.
16030556|NCT02662062|Drug|Cisplatin|35 mg/m2, IV (in the vein) every week for six weeks.
16030557|NCT02662062|Radiation|Radiotherapy|2.00Gy once daily for 32 fractions, 5 fractions/week over six weeks and two days (a total of 64Gy).
16030558|NCT02662036|Drug|Bupivicaine HCL|
16030559|NCT02662036|Drug|Liposomal bupivacaine|
16030560|NCT02662023|Drug|Bolus|A transversus abdominis catheter was inserted and ropivacaine 0.2% administered as two separate bolus doses of 24 mL each: one at time point zero and one 3 hours later.
16030561|NCT02662023|Drug|Basal|A transversus abdominis catheter was inserted and ropivacaine 0.2% administered as a continuous basal infusion (8 mL/h) from time point zero for the following 6 hours.
16030562|NCT02661997|Behavioral|Tai Chi Intervention|All components of the program derive from the classical Yang Tai Chi 108 postures, which has been shown to be a moderate intensity exercise. Each Tai Chi session will last 60 minutes, twice a week for 12 weeks. In the first session, the Tai Chi instructors will explain exercise theory and procedures of Tai Chi. In subsequent sessions, subjects will practice Tai Chi under the instruction of one of the Tai Chi instructors. Every session will include the following components: (1) warm up and a review of Tai Chi principles; (2) meditation with Tai Chi movement; (3) breathing techniques; and (4) relaxation. The investigators will instruct patients to practice at least 30 minutes a day at home throughout the intervention period and will provide them with training materials for home practice.
16030563|NCT02661997|Behavioral|Wellness Intervention|The investigators will utilize a wellness education program for the control group because this approach has been successfully used in other Tai Chi studies from the investigators' team. Participants in the Wellness condition will also attend two 60-minute sessions per week for 12 weeks. The Wellness condition will correspond to the VA Whole Health Program to emphasize wellness across various domains (e.g., physical, emotional, and spiritual lives.) Each session will include a video clip as well as a brief mindfulness exercise that corresponds with the material being presented. The project coordinator for this study will provide the didactic lessons.
16030564|NCT02661971|Drug|Docetaxel|Docetaxel 50 mg/m², d1
16030565|NCT02661971|Drug|Oxaliplatin|Oxaliplatin 85 mg/m², d1
16030566|NCT02661971|Drug|Calciumfolinat|Leucovorin 200 mg/m², d1
16030567|NCT02661971|Drug|5-Fluorouracil|5-FU 2600 mg/m², d1
16030568|NCT02661971|Biological|Ramucirumab|Ramucirumab 8mg/kg, d1
16030569|NCT02661958|Drug|S6G5T-3|once a day topical cream
16030570|NCT02661958|Drug|S6G5T-1|once a day topical cream
16030571|NCT02661958|Drug|S6G5T-5|once a day topical cream
16030572|NCT02661958|Drug|S6G5T-6|once a day topical cream
16030573|NCT02661958|Drug|S6G5T-7|once a day topical cream
16030574|NCT02661958|Drug|S6G5T-8|once a day topical cream
16030575|NCT02661945|Device|Near focus with narrow band imaging|
16030576|NCT02661932|Drug|Letrozole|"Patients start ovarian stimulation protocol according to their menstrual cycle phase at enrollment (standard or random start). Ovarian stimulation includes gonadotropins administration in a GnRH antagonist protocol Standard Protocol: letrozole is orally administered 2 tablets per day (2,5mgx2/d) from cycle day 2 throughout the ovarian stimulation with gonadotropins protocol until ovulation triggering. GnRH antagonist is administered as soon as at least one follicle reaches 14 mm.
~Random start protocol: letrozole is administered throughout the stimulation together with gonadotropins and GnRH antagonist, until ovulation triggering.
~Oocytes are collected 36h after ovulation triggering. All patients receive GnRH antagonist after oocyte retrieval for 3-7 days or until chemotherapy starts, to induce luteolysis."
16030577|NCT02661919|Device|Emfit mattress sensor|Patients who are being monitored in the Epilepsy Monitoring Unit will have an Emfit mattress sensor placed under their mattress and the effectiveness of the alarm system will be tested.
16030578|NCT02661906|Other|SKY|Sudarshan Kriya Yoga is a rhythmic breathing exercise with slow and fast breath at a particular pace.It is recommended for stress management as yoga is a mind body control tool. SKY is having effect on multiple organ thus causing the positive effect.
16030579|NCT02661893|Drug|JNJ-42847922|A single oral dose of 40 milligram (mg) (=2*20 mg) dose of JNJ42847922 on Day 1, Day 5 and Day 12.
16030580|NCT02661893|Drug|Rifampin|Oral dose of rifampin 600 mg (2*300 mg) on Day 5 and once daily dosing of rifampin with an oral dose of rifampin 600 mg (2*300 mg) on Days 5 to 12.
16030581|NCT02661880|Behavioral|preferred music|listening to preferred music choices
16030582|NCT02661867|Behavioral|delivery|delivery either vaginal or by cesarean section
16030583|NCT02661854|Biological|MM09 Mannosylated 5.000 subcutaneous|Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 5.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous
16030584|NCT02661854|Biological|MM09 Mannosylated 10.000 subcutaneous|Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 10.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous
16030585|NCT02661854|Biological|MM09 Mannosylated 30.000 subcutaneous|Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 30.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous
16030586|NCT02661854|Biological|MM09 Mannosylated 50.000 subcutaneous|Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 50.000 MTU (Mannosylated Therapeutic Units)/ml subcutaneous
16030587|NCT02661854|Biological|MM09 Mannosylated 5.000 sublingual|Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 5.000 MTU (Mannosylated Therapeutic Units)/ml sublingual
16030588|NCT02661854|Biological|MM09 Mannosylated 10.000 sublingual|Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 10.000 MTU (Mannosylated Therapeutic Units)/ml sublingual
16030589|NCT02661854|Biological|MM09 Mannosylated 30.000 sublingual|Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 30.000 MTU (Mannosylated Therapeutic Units)/ml sublingual
16030590|NCT02661854|Biological|MM09 Mannosylated 50.000 sublingual|Mixture of the following mites: Dermatophagoides pteronyssinus and Dermatophagoides farinae, allergen extract with a concentration of 50.000 MTU (Mannosylated Therapeutic Units)/ml sublingual
16030591|NCT02661854|Biological|Subcutaneous placebo|Comparison between placebo and active group
16030592|NCT02661854|Biological|Sublingual placebo|Comparison between placebo and active group
16030593|NCT02661841|Other|LI-Guided Therapy|Preemptive treatment according to LI monitoring
16030594|NCT02661841|Other|Heart Failure Guidelines|Treatment according to clinical signs
16030595|NCT02661828|Other|Two-Week Antidepressant Taper Regimen|Days 1-7: 50% of baseline antidepressant dose taken; Days 8-14: 25% of baseline antidepressant dose taken; Day 15: Stop antidepressant.
16030596|NCT02661828|Other|One-Week Antidepressant Taper Regimen|Days 1-3: 50% of baseline antidepressant dose taken; Days 4-7: 25% of baseline antidepressant dose taken; Day 8: Stop antidepressant.
16030597|NCT02661815|Drug|Paclitaxel|Please see arm/group description.
16030598|NCT02661815|Drug|Ricolinostat|Please see arm/group description.
16030599|NCT02661815|Drug|Bevacizumab|Please see arm/group description.
16030600|NCT02661802|Other|Oxygen Supplementation|Oxygen delivery was continuous by mask at 40%
16030601|NCT02661789|Drug|Goserelin 3.6 mg implant|Pharmacologically induced biphasic sex-steroid hormone fluctuation
16030602|NCT02661789|Drug|Placebo|Injection of saline
16030603|NCT02661750|Drug|Bowel Preparation|"Standard 1/2 Dose: 153 g MiraLAX + 32 oz Gatorade 2 liters, 2 liters NuLYTELY, 1 liter MoviPrep, 16 oz (1 bottle) SuPREP, 10 oz (1 bottle) MagCitrate.
~Standard Full Dose: 306 g MiraLAX + 64 oz Gatorade, 4 liters NuLYTELY, 2 liters MoviPrep, 32 oz (2 bottles) SuPREP, 20 oz (2 bottles) MagCitrate.
~Step 1: 51 g MiraLAX* noon the day-prior; Full dose - 51 g MiraLAX 6 PM day-prior; 1/2 dose 4 hours before the colonoscopy.
~Step 2: 1/2 dose noon the day-prior; Full dose 6 PM the day-prior; 1/2 dose 4 hours before the colonoscopy.
~Step 3: Full dose noon the day-prior; Full dose 6 PM the day-prior; 1/2 dose 4 hours before the colonoscopy.
~Step 4: 1/2 dose 6 PM 2 days-prior; Full dose noon the day-prior; Full dose 6 PM the day-prior; 1/2 dose 4 hours before the colonoscopy.
~Step 5: Full dose 6 PM 2 days-prior; Full dose noon the day-prior; Full dose 6 PM the day-prior; 1/2 dose 4 hours before the colonoscopy."
16030604|NCT02661737|Device|YVOIRE volume s|
16030605|NCT02661724|Behavioral|TCBR-Pain|The interactive TCBR-Pain uses programmed learning, skill development and behavioral practice to engage persons with burn pain in self-management of pain and related problems. The TCB-Pain program includes 7 lessons addressing key dimensions of pain management for persons with burn injury. Each session is about 20 minutes and focuses on burn injury recovery and life style education. Sessions begin with a brief self-assessment and in later sessions, the participant is given graphical feedback on their progress. The lessons are narrated and include closed captioning, are animated, and include branching to provide personalized content.
16030684|NCT02661100|Biological|Poly-ICLC|2mg given subcutaneously on day 1 and 2 of each 3 week cycle. Given for 4 cycles
16030685|NCT02661087|Procedure|Hysteroscopic resection with bipolar energy|Hysteroscopic resection with bipolar energy
16030606|NCT02661711|Drug|Aflibercept|"2mg of 40mg/ml of Eylea Solution administered via intravitreal injection every four weeks for three months (loading dose), followed by a treat and extend protocol up to 12 months. Extension from monthly to 6, 8, 10 and 12 week follow up will occur where there is no reduction in macula oedema compared with the previous visit.
~Number of cycles; minimum of 5 injections and maximum of 13 injections per study eye."
16030607|NCT02661698|Dietary Supplement|Omega-3 oil: DHA enriched|3 x 1 g capsules containing a SMEDDS formulation of an DHA-enriched oil: 50% DHA + 15% EPA totalling 900 mg DHA and 270 mg of EPA
16030608|NCT02661698|Dietary Supplement|Placebo|3 x 1 g capsules Placebo: olive oil
16030609|NCT02661698|Dietary Supplement|Omega-3 oil: EPA enriched|3 x 1 g capsules containing a SMEDDS formulation of an EPA-enriched oil: 50% EPA + 20% DHA totalling 900 mg EPA and 360 mg of DHA
16030610|NCT02661685|Biological|autologous IKDC-like cells|Subject received autologous IKDC-like cells every 14 days
16030613|NCT02661659|Biological|Multipeptide vaccine S-588210|
16030614|NCT02661646|Device|Advanced Pneumatic Compression Device|Advanced Pneumatic Compression Device
16030615|NCT02661633|Device|BrainScope Ahead 200iD|The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT3), Electrophysiological Function; Neurocognitive Performance Assessment and a balance/sway measurement. BrainScope Ahead 200iD device will be used to perform EEG.
16030616|NCT02661633|Device|Advanced MRI Neuroimaging|Diffusion tensor imaging (DTI) is a magnetic resonance imaging technique that enables the measurement of the restricted diffusion of water in tissue in order to produce neural tract images instead of using this data solely for the purpose of assigning contrast or colors to pixels in a cross sectional image.
16030617|NCT02661620|Device|REDAPT Revision Femoral System modular stem|Medical record review for retrospective information and observational prospective data collection of standard of care items at 5 years and 10 years post operatively plus a 7.5 year post op telephone call to assess stem status and adverse events.
16030618|NCT02661607|Procedure|Point of care echocardiography|Point of echocardiography is performed after routine placement of central venous catheterization and compared with routine chest radiography
16030619|NCT02661607|Device|Central venous catheter placement|Central venous catheter placement is performed as per local guidelines in critically ill patients
16030620|NCT02661607|Procedure|Chest radiography|Routine chest radiography is performed after central venous catheter placement in critically ill patients
16030621|NCT02661594|Drug|APD421 5 mg|Therapeutic dose of amisulpride
16030622|NCT02661594|Drug|APD421 40 mg|Supra-therapeutic dose of amisulpride
16030623|NCT02661594|Drug|Moxifloxacin|Positive control for assay sensitivity
16030624|NCT02661594|Drug|Placebo|Placebo comparator to establish baseline for calculating change in QTcF
16030625|NCT02661581|Behavioral|Peer Support|The intervention is lifestyle change. First, the peer leaders will be trained how to conduct diabetes self-management education and support sessions. During the first 3 months, all the participants will attend the diabetes self-management education sessions. The participants in the intervention arm will also receive diabetes self-management support sessions as well. In the end of the first 3 months, the intervention group participants will receive weekly support sessions for 9 months.
16030626|NCT02661555|Other|Aerobic exercise|
16030627|NCT02661542|Drug|FF-10502-01|
16030628|NCT02661529|Procedure|Transesophageal Echocardiogram (TEE)|Transesophageal echocardiography (TEE) is a test that produces pictures of the heart. TEE uses high-frequency sound waves (ultrasound) to make detailed pictures of the heart and the arteries that lead to and from it. Unlike a standard echocardiogram, the echo transducer that produces the sound waves for TEE is attached to a thin tube that passes through the mouth, down the throat and into the esophagus. Because the esophagus is so close to the upper chambers of the heart, very clear images of those heart structures and valves can be obtained.
16030629|NCT02661529|Procedure|Transthoracic Echocardiogram (TTE)|"An echocardiogram is a type of ultrasound test that uses high-pitched sound waves that are sent through a device called a transducer. The device picks up echoes of the sound waves as they bounce off the different parts of the heart. These echoes are turned into moving pictures of the heart that can be seen on a video screen.
~Transthoracic echocardiogram (TTE) is the most common type of echocardiogram. Views of the heart are obtained by moving the transducer to different locations on the chest or abdominal wall."
16030630|NCT02661529|Other|Saline/Air Mixture|The Saline/Air mixture consists of 10 milliliters of sterile saline and 0.5 milliliters of air agitated together in a syringe prior to injection.
16030631|NCT02661529|Other|Saline/Blood Mixture|The Saline/Blood mixture consists of 9 milliliters of sterile saline and 0.5 - 1.0 milliliters of blood agitated together in a syringe prior to injection.
16030632|NCT02661503|Drug|Bleomycin|
16030633|NCT02661503|Drug|Etoposide|
16030634|NCT02661503|Drug|Doxorubicin|
16030635|NCT02661503|Drug|Cyclophosphamide|
16030636|NCT02661503|Drug|Vincristine|
16030637|NCT02661503|Drug|Procarbazine|
16030638|NCT02661503|Drug|Prednisone|
16030639|NCT02661503|Drug|Brentuximab Vedotin|
16030640|NCT02661503|Drug|Dacarbazine|
16030641|NCT02661503|Drug|Dexamethasone|
16030642|NCT02661490|Biological|Norovirus GI.1/GII.4 Bivalent VLP Vaccine|Norovirus GI.1/GII.4 bivalent VLP vaccine adjuvanted with aluminum hydroxide, without MPL for IM injection
16030643|NCT02661490|Drug|0.9% sodium chloride (saline)|norovirus bivalent placebo-matching vaccine
16030644|NCT02661490|Biological|Norovirus GI.1/GII.4 Bivalent VLP Vaccine|Norovirus GI.1/GII.4 bivalent VLP vaccine adjuvanted with MPL and aluminum hydroxide for IM injection
16030645|NCT02661477|Drug|pegylated interferon alfa 2|
16030646|NCT02661477|Other|Placebo|0,9% natrium chlorine solution
16030686|NCT02661087|Procedure|Hysteroscopic resection with monopolar energy|Hysteroscopic resection with monopolar energy
16030649|NCT02661451|Device|SAPIEN 3 THV|
16030650|NCT02661451|Biological|Optimal Heart Failure Therapy|
16030651|NCT02661438|Drug|Placebo to Ciprofloxacin DPI (BAYQ3939)|Placebo to Ciprofloxacin DPI, 3 doses during test session, 1 additional dose for patients during device training
16030652|NCT02661425|Other|EnteraGam|Serum-derived bovine immunoglobulin/protein isolate (SBI) is the nutritional ingredient in EnteraGam. SBI contains a minimum of 50% immunoglobulin. The protein isolate is a light-colored powder. Each packet contains SBI (5.0 g) and the following inactive ingredients: dextrose (5.0 g) and a trace amount of sunflower lecithin.
16030653|NCT02661386|Device|Motility Procedure|The use of esophageal manometry device during general anesthesia
16030654|NCT02661373|Drug|SJ733|SJ733 is an oral, novel inhibitor of Plasmodium Falciparum plasma membrane protein PFATP4. It will be administered as a single, multi, or boosted oral dose.
16030655|NCT02661373|Drug|Cobicistat|Commercially available cobicistat 150 mg tablets will be used. It will be administered as a single oral dose together with SJ733.
16030656|NCT02661360|Behavioral|Swaddling Intervention for Preterm Infants|Procedure for swaddling includes folding one corner of the blanket down two thirds of the way down the blanket in order to make the blanket into a triangular shape. The infant will be positioned with shoulders at the fold of the blanket. The infant will be positioned with the blanket so that elbows, hips, and knees flexed with hands near the face by wrapping one side of the blanket across the chest holding the hands in place, pulling the bottom corner up toward the infant's face, and securing the blanket with the last corner pulled across the infant's chest again and around their back. The blanket will be tight enough to keep extremities in place but one finger will be able to be placed between the infant and the blanket.
16030657|NCT02661360|Behavioral|Unswaddled Control|Procedure for control is blanket loosely draped across the infant without providing containment and without touching the anterior surface of the infant.
16030658|NCT02661347|Drug|Risperidone|The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.
16030659|NCT02661347|Device|tDCS|Transcranial direct current stimulation (tDCS) is a form of non-invasive brain stimulation in which sub-threshold transcranial electric current (in the range of 0.4-2 mA) is applied via two conductive saline soaked electrodes placed on the scalp using a Soterix Medical 1x1 line tDCS Model 1300 low-intensity stimulator.
16030660|NCT02661334|Dietary Supplement|Creatine Monohydrate|Creatine monohydrate is a very common supplement used by enthusiasts, athletes, and the general populace
16030661|NCT02661334|Dietary Supplement|Rice Flour|rice flour powder matched for color, appearance, taste, and solubility
16030662|NCT02661321|Other|No intervention was used in this study, this was an observational study|
16030663|NCT02661308|Device|Litebook|
16030664|NCT02661295|Drug|Ferric Citrate|Study participants will receive ferric citrate at a starting dose of 2 tablets with each meal if serum phosphorus levels are ≥ 6.0 mg/dL calcium levels are in the normal range, Tsat ≥ 20 and < 50% and ferritin ≥ 200 and < 500 ng/ml after a 2 week wash out period.
16030665|NCT02661282|Biological|Autologous Cytomegalovirus-specific Cytotoxic T-lymphocytes|Given IV
16030666|NCT02661282|Other|Laboratory Biomarker Analysis|Correlative studies
16030667|NCT02661282|Drug|Temozolomide|Given PO
16030668|NCT02661282|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16030669|NCT02661269|Device|Videomicroscopy of the sublingual microcirculation|Measuring total vessel density with the Cytocam-IDF camera.
16030670|NCT02661269|Device|Bio-impedance measurements.|measuring resistance and reactance with the BIVA method.
16030671|NCT02661256|Device|NCPAP|Does NCPAP induce dysphagia in neonates? Each baby will be evaluated for dysphagia (using fluoroscopy) while on NCPAP and off NCPAP.
16030672|NCT02661256|Dietary Supplement|Varibar® Thin Liquid Barium Sulfate for Suspension|Liquid barium is used as a contrast material to allow visualization of swallowed boluses under fluoroscopy.
16030673|NCT02661243|Device|Biohorizons Laser-lok bonelevel dental implants|Insertion of Biohorizons Laser-lok bonelevel dental implants to replace missing (pre)molars or to stabilize a denture
16030674|NCT02661230|Device|COGNIPLUS|"Run 1 Video game: Phasic Alertness (Alert S1) Instruction phase 2 minutes, 2 x 3 minutes of rest, followed by 5 x 60 sec of video game activity, alternating with 60 sec of rest.
~Run 2 Video game: Intrinsic Alertness (Alert S2) Instruction phase 2 minutes, 2 x 3 minutes of rest, followed by 5 x 60 sec of video game activity, alternating with 60 sec of rest.
~Run 3 Video game: Visual modality (Select S1) Instruction phase 2 minutes, 2 x 3 minutes of rest, followed by 5 x 60 sec of video game activity, alternating with 60 sec of rest.
~Run 4 Video game: Acoustic / Stimulus Combinations (Select S2) Instruction phase 2 minutes, 2 x 3 minutes of rest, followed by 5 x 60 sec of video game activity, alternating with 60 sec of rest."
16030675|NCT02661217|Drug|LCZ696|"LCZ696 film-coated tables were supplied to the investigators. Tablets were taken with a glass of water, and were administered with or without food.
~The target dose of LCZ696 was 200 mg twice daily. Starting dose of LCZ696 was either 50 or 100 mg, twice daily. The dose of LCZ696 should be doubled every 2-4 weeks to achieve the target dose of 200 mg twice daily, as tolerated by the patient."
16030676|NCT02661204|Device|Automated breast ultrasound examination (ABUS)|Automated breast ultrasound examination
16030677|NCT02661191|Drug|oral cholecalciferol|Inhaled corticosteroids and long-acting beta-agonists, salbutamol
16030678|NCT02661178|Drug|emodepside (BAY 44-4400)|
16030679|NCT02661178|Drug|placebo|
16030680|NCT02661152|Drug|Nimorazole|Hypoxia gene profile is expected to discriminate between HNSCC responders and non-responders to hypoxic modification with nimorazole during radiotherapy. In DAHANCA 30 expected non-responders are randomized to +/- nimorazole during radiotherapy (non-inferiority study). Thus, similar efficacy of radiotherapy is expected in these groups. More hypoxic tumours receive nimorazole after DAHANCA standards.
16030687|NCT02661074|Other|Questionnaire|"A questionnaire will be completed in order to collect data on:
~Potential allergic manifestations after fish contact: asthma, allergic rhinitis, conjunctivitis, chronic or acute urticaria, dermatitis/eczema, or severe allergic manifestations (angioedema, bronchospasm, anaphylaxis),
~Occupational and/or domestic exposure to fish."
16030688|NCT02661061|Drug|Ketamine|A sub-anaesthetic dose of ketamine will be administered in four infusions, each two weeks apart.
16030689|NCT02661061|Drug|Midazolam|A sub-anaesthetic dose of midazolam will be administered in four infusions, each two weeks apart.
16030690|NCT02661048|Device|CyberHeart System|The CyberHeart system uses proprietary software to assist the cardiologist to contour ablation targets. Standard radiosurgical techniques are then used to accomplish ablation
16030691|NCT02661035|Drug|Allopurinol|300 mg/day (for peds -150 mg/m^2/day), day -6 and continue through day 0 or longer if clinically indicated
16030692|NCT02661035|Drug|Fludarabine|30 mg/m^2 IV over 1 hour, day -6, -5, -4, -3 and -2
16030693|NCT02661035|Drug|Cyclophosphamide|50 mg/kg IV over 2 hours, day -6
16030694|NCT02661035|Drug|ATG|Only for patients with an unrelated donor (URD) and NO multi-agent chemotherapy 3 months prior to transplant. ATG will be administered IV every 12 hours for 6 doses on days -6, -5, and -4 according to institutional guidelines. Methylprednisolone 1 mg/kg IV administered immediately prior to each dose of ATG (6 doses).
16030695|NCT02661035|Radiation|TBI|All patients who have had previous radiation therapy or TBI will be seen by Radiation Oncology prior to entrance on the protocol for approval for additional 200 cGy of TBI. TBI may be delivered by local guidelines provided the effective dose is equivalent to what is recommended in the TBI Guidelines. The dose of TBI will be 200 cGy given in a single fraction on day -1.
16030696|NCT02661035|Drug|Tacrolimus|"All patients will receive tacrolimus therapy beginning on day -3. Initial dosing of tacrolimus will be 0.03 - 0.05 mg/kg/day IV; if the recipient body weight is <40 kg, dosing will be 3 times daily, and if ≥ 40 kg, twice daily or per current institutional guidelines.
~An attempt will be made to maintain a trough level of 5-10 ng/mL and subsequent dose modifications will be provided by the pharmacist.
~Once the patient can tolerate oral medications and has a reasonable oral intake, tacrolimus will be converted to an oral form based on the current IV dose providing normal renal and hepatic function and no major drug interactions.
~The timing of the tacrolimus taper will be at the discretion of the treating physician, but in general:
~Taper begins at day +100 +/- 10 days, if the patient is stably engrafted and has no active GVHD.
~Taper to zero by reducing dose by approximately 10% a week (rounded to nearest pill size), with a goal to discontinue by month 6 post-HCT."
16030697|NCT02661035|Drug|MMF|"3 gram/day IV/PO for patients who are ≥ 40 kg divided in 2 or 3 doses. In obese patients (>125% IBW) 15 mg/kg every 12 hours may be considered. Pediatric patient (<40 kilograms) will receive MMF at the dose of 15 mg/kg/dose every 8 hours beginning day -3. MMF dosing will be monitored and altered as clinically appropriate based on institutional guidelines. Patients will be eligible for MMF dosing and pharmacokinetics studies.
~MMF will stop at day +30 or 7 days after engraftment, whichever day is later, if no acute GVHD. (Definition of engraftment is 1st day of 3 consecutive days of absolute neutrophil count [ANC) ≥ 0.5 x 109 /L]). If no donor engraftment, MMF will continue as long as clinically indicated."
16030698|NCT02661035|Biological|Peripheral Blood Stem Cells|On day 0, patients will receive an allogeneic transplant using PBSC which are CD34+ selected as the donor graft. The graft will be infused over 15-60 minutes after premedication with acetaminophen 650 mg PO and diphenhydramine 25 mg PO/IV with doses adjusted for pediatric patients.
16030699|NCT02661035|Biological|Related or Unrelated Bone Marrow Cells|On day 0, a target dose of 3 x 10^8 nucleated cells/kg recipient weight will be collected. The graft will be infused over 15-60 minutes after premedication with acetaminophen 650 mg PO and diphenhydramine 25 mg PO/IV with doses adjusted for pediatric patients.
16030700|NCT02661022|Drug|SL-401/ Pomalidomide/ Dexamethasone|
16030701|NCT02660983|Drug|Donepezil hydrochloride|
16030702|NCT02660983|Drug|Donepezil matching placebo|
16030703|NCT02660983|Drug|Donepezil hydrochloride|
16030704|NCT02660970|Other|Acupressure|Children will have to wear a 'seasickness-band', which has the effect of acupressure
16030705|NCT02660970|Other|Placebo-band|Children will have to wear a 'placebo-wristband'
16030706|NCT02660970|Drug|Iberogast|Children will have to take Iberogast drops
16030707|NCT02660970|Other|Placebo-drops|Children will have to take placebo-drops
16030708|NCT02660957|Behavioral|self-determination smoking cessation|a self-help quitting leaflet plus a series of brief interventions using the AWARD model
16030709|NCT02660957|Other|placebo comparator|suggest a healthy life style as a placebo comparator
16030710|NCT02660944|Drug|RSLV-132|RNase-Fc fusion protein
16030711|NCT02660944|Drug|Placebo|Saline placebo
16030712|NCT02660931|Other|AKI Risk Notification|When a patient's calculated acute kidney injury risk exceeds the threshold value, the electronic medical record will notify the provider of the risk and that appropriate screening (BMP including serum creatinine) may be indicated.
16030713|NCT02660918|Drug|Bupivacaine|Paracervical injection of 20 mL 0.25% Bupivacaine at the completion of the procedure
16030714|NCT02660918|Other|Normal Saline|Equal volume injection of normal saline with the same paracervical technique
16030715|NCT02660905|Drug|E/C/F/TAF;|Evaluation of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Switch followed by Ledipasvir-Sofosbuvir Antiviral HCV Therapy
16030716|NCT02660905|Drug|Ledipasvir-Sofosbuvir|Evaluation of Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide Switch followed by Ledipasvir-Sofosbuvir Antiviral HCV Therapy
16030717|NCT02660892|Dietary Supplement|Protein intake|"Oral consumption of eight hourly experimental meals
~4 tracer free experimental meals containing a mixture of free amino acids and calories from protein free flavoured liquid, protein free cookies and corn oil
~4 isotopically labeled experimental meals."
16030718|NCT02660879|Other|Written Document Educational Resource|A 2 page document with pictures discussing how to use an inhaler properly.
16030719|NCT02660879|Other|Online Video Education|Education which included step-by-step instruction on how to use their inhalers correctly as well as a webcam element that allowed users to see themselves practice their inhalers along with actors on screen.
16030720|NCT02660866|Drug|Placebo + background APT + SMT|Placebo drug therapy combined with standard medical therapy combined with Antiplatelet therapy (Aspirin therapy)
16030909|NCT02659683|Drug|Nexium 40 mg DR Capsules of AstraZeneca LP, USA|oral, cross over
16030721|NCT02660866|Drug|Vorapaxar 2.08 mg/d + background APT + SMT.|Vorapaxar 2.08 mg/d combined with standard medical therapy combined with Antiplatelet therapy (Aspirin therapy)
16030722|NCT02660853|Diagnostic Test|FEV1|Participants have FEV1 test
16030723|NCT02660840|Drug|0.5 mg Flupentixol film-coated tablet (test treatment)|single oral dose, fasted state, day 1 in period 1 or 2
16030724|NCT02660840|Drug|1 mg Flupentixol film-coated tablet (test treatment)|single oral dose, fasted state, day 1 in period 1 or 2
16030725|NCT02660840|Drug|5 mg Flupentixol film-coated tablet (test treatment)|single oral dose, fasted state, day 1 in period 1 or 2
16030726|NCT02660840|Drug|0.5 mg Flupentixol coated tablet (reference treatment)|single oral dose, fasted state, day 1 in period 1 or 2
16030727|NCT02660840|Drug|1 mg Flupentixol coated tablet (reference treatment)|single oral dose, fasted state, day 1 in period 1 or 2
16030728|NCT02660840|Drug|5 mg Flupentixol coated tablet (reference treatment)|single oral dose, fasted state, day 1 in period 1 or 2
16030730|NCT02660814|Other|Non-surgical periodontal treatment|"SRP under local anaesthesia, in a total of 2-3 clinical visits.
~Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush."
16030731|NCT02660814|Other|Gingival crevicular fluid collection|GCF collection with filter paper (Periopaper) using the intracrevicular method.
16030732|NCT02660801|Procedure|Spinal manipulation|A high-velocity and low-amplitude thrust delivered posteroanteriorly to a thoracic vertebra
16030733|NCT02660801|Procedure|Spinal mobilization|Three repetitions of a low-velocity and low-amplitude nonthrust movement delivered posteroanteriorly to a thoracic vertebra
16030734|NCT02660788|Other|Standard Reminder Postcard|
16030735|NCT02660788|Other|Family Physician Reminder Letter|
16030736|NCT02660775|Behavioral|schizophrenia|"The battery (ClaCoS) is composed by 6 tests and several scores will be recorded for each:
~for emotion perception : Facial emotions recognition task (TREF)
~for theory of mind : Movie for the assessment of social cognition ( MASC-VF)
~for attributional bias : Ambiguous Intentions Hostility Questionnaire ( AIHQ)
~for social perception and knowledge : interpretation score - with and without index, comprehension score ( PerSo )
~for empathy :Questionnaire of cognitive and affective empathy ( QCAE) for people with schizophrenia
~for self assessment : Self - assessment of social cognition (ACSo)"
16030737|NCT02660775|Behavioral|Autism|"The battery (ClaCoS ) is composed by 6 tests and several scores will be recorded for each:
~for emotion perception : Facial emotions recognition task(TREF ): total score, score per emotion, detection levels
~for theory of mind : Movie for the assessment of social cognition (MASC ) :total score, error type
~for attributional bias : Ambiguous Intentions Hostility Questionnaire (AIHQ) :hostility score, attribution score, aggression score
~for social perception and knowledge : interpretation score - with and without index, comprehension score ( PerSo )
~for empathy : Empathy quotient (EQ)
~for self assessment : Self - assessment of social cognition ( ACSo ): total score and scores per processes"
16030738|NCT02660775|Behavioral|Healthy controls|only social cognitive measures
16030739|NCT02660762|Drug|Vincristine|induction therapy I：1.4 mg/m2 IV d1, 8, 15, 22； consolidation therapy(Cycle 1)：1.4 mg/m2 IV d1, 8, 15, 22； Maintenance therapy: 1.4 mg/m2 intravenously every 3 months for a total of 2.5 years
16030740|NCT02660762|Drug|Daunorubicin|induction therapy I：60 mg/m2 IV d1, 8, 15, 22； consolidation therapy(Cycle 3)：25 mg/m2 IV d1, 8, 15, 22；
16030741|NCT02660762|Drug|Pegaspargase|induction therapy I: 2500U/m2,im,d8,22 Intensification therapy:2500U/m2 im, d2,23 consolidation therapy(Cycle 2，4)：2500U/m2 im, d1
16030742|NCT02660762|Drug|Prednisone|induction therapy I：60 mg/m2 PO d1-28; Maintenance therapy:prednisone 60 mg/m2 orally for 5 days every 3 months for a total of 2.5 years
16030743|NCT02660762|Drug|Intrathecal Methotrexate|induction therapy I：12.5 mg IT d15 induction therapy II：12.5 mg IT d1, 8, 15, 22
16030744|NCT02660762|Drug|Cyclophosphamide|induction therapy II:650 mg/m2 IV d1, 15, 29 consolidation therapy(Cycle 3)：650 mg/m2 IV，d29
16030745|NCT02660762|Drug|Cytarabine|induction therapy II:75 mg/m2 IV d1-4, 8-11, 15-18, 22-25 consolidation therapy(Cycle 1，2，4)：75 mg/m2 intravenously on days 1 to 5 consolidation therapy(Cycle 3):75 mg/m2 intravenously on days 31 to 34 and 38 to 41
16030746|NCT02660762|Drug|6-Mercaptopurine|induction therapy II:60 mg/m2 PO d1-28 Maintenance therapy:75 mg/m2 orally each day for a total of 2.5 years
16030747|NCT02660762|Drug|Methotrexate|Intensification therapy:3 g/m2 intravenously given on days 1, 8, and 22 Maintenance therapy:20 mg/m2 orally or intravenously once a week for a total of 2.5 years.
16030748|NCT02660762|Drug|Etoposide|consolidation therapy(Cycle 1，2，4)：100 mg/m2 intravenously on days 1 to 5
16030749|NCT02660762|Drug|dexamethasone|consolidation therapy(Cycle 1)：10mg/m2 orally on days 1 to 28
16030750|NCT02660762|Drug|thioguanine|consolidation therapy(Cycle 3): 60 mg/m2 orally on days 29 to 42
16030751|NCT02660762|Drug|intrathecal cytarabine|50 mg intrathecal cytarabine was given on 4 occasions 3 months apart during maintenance therapy.
16030752|NCT02660736|Drug|Albiglutide Liquid Auto-injector|Albiglutide liquid is provided as a fixed-dose, disposable auto-injector containing albiglutide liquid (50 mg). The auto-injector delivers the study treatment in an injection volume of 1.0 mL for the 50 mg dose
16030753|NCT02660736|Drug|Albiglutide Lyophilized DCC Pen Injector|Albiglutide is supplied as prefilled DCC Pen Injector. Each DCC contains lyophilized albiglutide 50 mg. When the injector pen product is reconstituted a neutral, isotonic solution is produced. The pen delivers albiglutide in an injection volume of 0.5 mL
16030754|NCT02660736|Drug|Placebo Liquid Auto-injector|Liquid albiglutide matching placebo is provided as a fixed-dose, disposable autoinjector containing placebo liquid. The auto-injector delivers the placebo in an injection volume of 1.0 mL for the 50 mg placebo dose.
16030755|NCT02660736|Drug|Placebo Lyophilized DCC Pen injector|Placebo is supplied as prefilled DCC Pen Injector. Each DCC contains matching placebo. When the injector pen product is reconstituted a neutral, isotonic placebo solution is produced. The pen delivers the placebo in an injection volume of 0.5 mL.
16030756|NCT02660723|Other|Healthy Volunteers|A catheter will be introduced in the arm vein and 14 ml of blood will be drawn in one 4 ml dry tube, one 5 ml heparinized tube for cell count and 5 1 ml TruCulture tubes.
16030758|NCT02660697|Procedure|Extraction site development|In the test group, extraction sockets presenting EDS Type 3-4 buccal bony dehiscences were treated by a novel minimally invasive tunnelised modified GBR approach (XSD).
16030759|NCT02660684|Drug|Prograf|Injection or oral
16030760|NCT02660684|Drug|Methotrexate|Injection
16030761|NCT02660684|Drug|Cyclosporine|Injection or oral
16030762|NCT02660671|Behavioral|Email outreach|Subjects will receive an email describing the importance of colorectal cancer screening and that s/he has been selected to participate in this VIP concierge service.
16030763|NCT02660671|Behavioral|Active choice|S/he will receive the ability to pre-commit and choose from 3 different appointment slots by clicking directly on the email.
16030764|NCT02660671|Behavioral|Financial incentive|The participant will receive the offering of $100 if s/he follows through with screening colonoscopy.
16030765|NCT02660658|Drug|Intrathecal dexmedetomidine|The dose of intrathecal DEX given to the next patient will be guided by modified Dixon's up-and-down method using 1.5 mg as a step size, which assumed to be of clinical importance
16030768|NCT02660632|Other|Thoracic epidural analgesia (TEA)|Epidural catheter will be inserted at T9-T11. Then, epidural analgesia will be activated with administering bolus of 10 mls 0.25% bupivacaine in conjunction with100 mcg fentanyl to establish a block. This will be followed by an infusion of 0.125% bupivacaine in conjunction with 2 mcg/ ml fentanyl at a rate of 10 mls /hour and then titrated to effect for up to 48 hour postoperative
16030769|NCT02660632|Other|Rectus sheath catheter block|Following insertion of bilateral rectus sheath catheters, 20 ml of 0.25% bupivacaine will be injected through each one. Then continuous infusion pumps will be connected to the catheters and set to deliver boluses of 20 mL of 0.25% bupivacaine, with a 4-hour lockout for up to 48 h postoperatively.
16030770|NCT02660619|Other|Psychiatric Research Interview for Substance and Mental Disorders (PRISM-5-Op)|
16030771|NCT02660606|Other|Prescription Opioid Misuse and Abuse Questionnaire (POMAQ)|
16030772|NCT02660593|Dietary Supplement|SanGrow Decoction|SanGrow Decoction is perpared according to the principle of Chinese medicine to treat thirsty and maransis.
16030773|NCT02660580|Drug|MSB11022|Participants received MSB11022 drug subcutaneously MSB11022 (Core Treatment Period), MSB11022 (Extended Treatment Period) and EU-Humira/MSB11022 arm.
16030774|NCT02660580|Drug|Humira®|Participants received EU-Humira subcutaneously in EU-Humira, EU-Humira/EU-Humira and EU-Humira/MSB11022 arm.
16030775|NCT02660567|Procedure|Amr maneuver|sustained traction of the anterior and posterior lips of the cervix by ovum forceps downwards and anteriorly until maximum yield for about 90 seconds
16030776|NCT02660554|Other|Polymerase Chain Reaction (PCR)|Respiratory samples called bronchoalveolar lavage (BAL) gathered from subjects in the PCR arm will be tested for the presence of MRSA using the Cepheid Xpert® Assay. Xpert® is a qualitative in vitro test designed for rapid detection and differentiation of Staphylococcus aureus (SA) and methicillin resistant Staphylococcus aureus (MRSA) using PCR amplification. MRSA is identified by the mecA gene and staphylococcal cassette chromosome mec (SCCmec). Xpert® Assay is approved by the Federal Drug Administration to detect MRSA in soft tissue samples. Once the PCR is completed, the results will be relayed to the treating physician, and antibiotic therapy (vancomycin or linezolid) will be started or stopped based on the study protocol. All BAL samples will be sent for routine bacterial cultures.
16030777|NCT02660541|Device|Betafoam|Comparison between 2 medical devices
16030778|NCT02660541|Device|Allevyn Silver Dressing|Comparison between 2 medical devices
16030779|NCT02660528|Drug|Tocilizumab|Subcutaneous tocilizumab
16030780|NCT02660515|Procedure|Additional wrist arthroscopy|
16030781|NCT02660515|Procedure|ORIF|
16030782|NCT02660502|Drug|Biochaperone insulin lispro 0.1 U/kg|Injection of a single dose of BioChaperone insulin lispro at the dose of 0.1 U/kg
16030783|NCT02660502|Drug|Biochaperone insulin lispro 0.2 U/kg|Injection of a single dose of BioChaperone insulin lispro at the dose of 0.2 U/kg
16030784|NCT02660502|Drug|Biochaperone insulin lispro 0.4 U/kg|Injection of a single dose of BioChaperone insulin lispro at the dose of 0.4 U/kg
16030785|NCT02660502|Drug|Humalog®|Injection of a single dose of Humalog® at the dose of 0.2 U/kg
16030786|NCT02660489|Drug|OC459|
16030787|NCT02660489|Drug|Placebo|
16030788|NCT02660489|Other|Rhinovirus|Inoculation with rhinovirus serotype 16
16030789|NCT02660463|Other|"Registration of the diagnosis CTEPH"|Registration of risk factors for thromboembolic events
16030790|NCT02660450|Other|Prescription for Workload|Prescription from 65% VO2max for 5 min of exercise
16030791|NCT02660450|Other|Prescription for Heart Rate|Prescription from 60 - 65% Maximum Heart Rate for 5 min of exercise
16030792|NCT02660450|Other|Prescription Self Selected|Prescription Self Selected from Perceived exertion at 3 - 4 (moderate) for 5 min of exercise
16030793|NCT02660437|Other|Pulmonary Rehabilitation program|Patients will attend a comprehensive 3-week PR program (12sessions/ 60min·day) including high intensive interval exercise equivalent to 100% of peak work rate (WRpeak) with 30sec work periods interspersed with 30sec rest periods for 30min and light resistance training (3muscle groups/ 4sets each/10repetitions; ~30min).
16030794|NCT02660424|Drug|VX-150|
16030795|NCT02660424|Drug|Placebo|
16030796|NCT02660411|Drug|Sevoflurane|Sevoflurane will be administered by inhalation for anesthesia maintenance. The concentration of inhaled sevoflurane will be adjusted to maintain the BIS value between 40 and 60, with or without 50% nitrous oxide. Sevoflurane inhalational concentration will be decreased towards the end of surgery. Sevoflurane inhalation will be stopped at the end of surgery.
16030797|NCT02660411|Drug|Propofol|Propofol will be administered by intravenous infusion for anesthesia maintenance. The infusion rate of propofol will be adjusted to maintain the BIS value between 40 and 60, with or without 50% nitrous oxide. Propofol infusion rate will be decreased towards the end of surgery. Propofol infusion will be stopped at the end of surgery.
16030798|NCT02660398|Procedure|Standardized NMBD Management|The intervention phase will introduce a standardized research protocol that spells out NMBD management, including how muscle relaxant should be administered and monitored, and how reversal with neostigmine should be done.
16033583|NCT02641041|Biological|BIIB033|single or multiple dose
16030799|NCT02660385|Behavioral|Cognitive Behavioral Therapy for Insomnia|This behavioral intervention includes strategies for modifying thoughts, cognitions and behaviors regarding sleep provided by a therapist in a group format.
16030800|NCT02660385|Behavioral|Self-Management Education for Heart Failure|This is an educational education designed to teach patients about self-management their heart failure. It includes information on medications, lifestyle, cardiac devices, diet, and when to seek assistance from a health care provider.
16030801|NCT02660372|Drug|Imonogas|Simethicone 120 mg in gel capsules
16030802|NCT02660372|Drug|Espumisan|Simethicone 40 mg in gel capsules
16030803|NCT02660359|Biological|Botulinum toxin type A|600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points.
16030804|NCT02660359|Biological|Botulinum toxin type A|800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points
16030805|NCT02660359|Drug|Placebo|AbobotulinumtoxinA Placebo 600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points
16030806|NCT02660359|Drug|Placebo|AbobotulinumtoxinA Placebo 800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points
16030807|NCT02660346|Drug|Daptomycin|Control Arm Treatment if used as monotherapy. Study Arm Treatment if used in combination with ceftaroline.
16030808|NCT02660346|Drug|Vancomycin|Control Arm Treatment
16030809|NCT02660346|Drug|Ceftaroline|Study Arm Treatment
16030810|NCT02660333|Dietary Supplement|Placebo|Maltodextrin - 11g/day
16030811|NCT02660333|Dietary Supplement|Prebiotic|Fructooligosaccharide - 11g/day
16030812|NCT02660333|Dietary Supplement|Synbiotic|Fructooligosaccharide + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019 - 11g/day
16030813|NCT02660320|Device|Dermabrasion|Preparing the graft bed before epidermal cell suspension The epidermis can be removed using ablative CO2 or Erbium laser. We will assess the efficacy of using instead micro-needles to create micro-holes that will allow the melanocytes to reach the lower layers of the epidermis and thus repigment the lesional skin.
16030814|NCT02660320|Device|Laser placebo|The epidermis can be removed using ablative CO2 or Erbium laser. We will assess the efficacy of using instead micro-needles to create micro-holes that will allow the melanocytes to reach the lower layers of the epidermis and thus repigment the lesional skin.
16030815|NCT02660307|Other|PROGRESS group|
16030816|NCT02660294|Biological|platlet rich plasma|Platelet-rich plasma (PRP) is prepared from fresh whole blood which is collected from a peripheral vein, stored in acid citrate dextrose solution A (ACD-A) anticoagulant and processed to increase platelets by separating various components of blood
16030817|NCT02660281|Radiation|Total Body Irradiation 1200 cGy|1200 cGy TBI in 8 fractions
16030818|NCT02660281|Drug|Fludarabine|Fludarabine
16030819|NCT02660281|Drug|Pre-Stem Cell Infusion Cyclophosphamide|Cyclophosphamide given prior to the stem cell infusion
16030820|NCT02660281|Drug|Pre-Stem Cell Infusion Mesna|Mesna given prior to the stem cell infusion
16030821|NCT02660281|Drug|Busulfan|Busulfan
16030822|NCT02660281|Drug|Melphalan|Melphalan
16030823|NCT02660281|Procedure|Stem Cell Infusion|Stem cell infusion
16030824|NCT02660281|Drug|Post-Stem Cell Infusion Cyclophosphamide|Cyclophosphamide given after the stem cell infusion
16030825|NCT02660281|Drug|Post-Stem Cell Infusion Mesna|Mesna given after the Stem Cell Infusion
16030826|NCT02660281|Drug|Thiotepa|Thiotepa
16030827|NCT02660268|Other|Clinical Pathway|Implementation of a Clinical Pathway for Medical and Surgical Management of Hip Prosthesis Infections
16030828|NCT02660255|Drug|Cannabidiol|Formulation: 100mg/ml CBD (Epidiolex) Solution
16030829|NCT02660242|Drug|G-Pen Mini™ (glucagon injection)|Glucagon (150 µg) 5 minutes before the start of exercise (SQ-abdomen).
16030830|NCT02660242|Other|Glucose Tabs|Dextrose tabs orally (20 grams) 5 minutes before the start of exercise and at 30 minutes of exercise (total 40 grams).
16030831|NCT02660242|Other|Basal Insulin Reduction|Basal insulin reduction to 50% 5 minutes before the start of exercise.
16030832|NCT02660229|Drug|Oxycodone Hydrochloride|Oxycodone injection
16030833|NCT02660229|Drug|Morphine Sulphate|Morphine sulphate injection
16030834|NCT02660203|Procedure|Forced expiration|"Amongst chest physiotherapy technics, forced expiration is one of the passive procedures used in pediatrics.
~The patient is positioned on ipsilateral decubitus and the physiotherapist is behind the patient, placing one hand on the patient abdomen and the other on the patient lateral chest. During expiration, the abdominal hand apply a pressure directed posteriorly and superiorly for the patient. Simultaneously, the thoracic hand apply a pressure posteriorly and inferiorly for the patient. The session's duration is 15 minutes after what the physiotherapist replace the patient in dorsal decubitus.Two sessions a day will be performed"
16030835|NCT02660190|Drug|hexaminoavolunate|
16030836|NCT02660190|Procedure|WL cystoscopy|
16030837|NCT02660177|Drug|Metamizole|metamizole IV administration
16030838|NCT02660164|Device|Nautilus BrainPulse Recording|Comparison of Nautilus BrainPulse recordings in subjects who have a concussive event (Cohort A) to Nautilus BrainPulse recording in subjects who do not experience a concussive events (Cohort B or matched subjects to Cohort A). Recordings are obtained over a 2 week period every 2 to 3 days (at least 5 recordings per subject).
16030839|NCT02660151|Device|Hyper-CL™ lens|
16030840|NCT02660151|Device|Regular soft contact lens|
16030841|NCT02660151|Drug|Salt solution|
16030842|NCT02660138|Biological|Botulinum toxin type A|600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points
16030843|NCT02660138|Biological|Botulinum toxin type A|800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points
16030844|NCT02660138|Drug|Placebo|AbobotulinumtoxinA Placebo 600 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points
16030845|NCT02660138|Drug|Placebo|AbobotulinumtoxinA Placebo 800 U intra detrusor injection in two treatment periods (Initial and Retreatment phase) delivered at 30 injection points
16030910|NCT02659683|Drug|Torrent's Esomeprazole Magnesium DR Capsules 40 mg|oral, cross over
16144381|NCT01824823|Other|placebo|Given PO
16030846|NCT02660125|Procedure|Endometrial scratch injury|midluteal single endometrial strip will be taken using a Novak curett under general anasthesia to avoid discomfort and cramping and to proceed to cervical dilatation in case of forbidden cervix
16030847|NCT02660112|Drug|(+)-Epicatechin|25mg (+)-Epicatechin capsules. Starting dose 75mg total daily dose (one 25mg cap taken three times per day). Dose escalation at 12 weeks for non-responders to 150mg total daily dose (two 25mg caps taken three times per day)
16030848|NCT02660099|Behavioral|Internet-delivered Cognitive Behavior Therapy|The treatment consists of standard cognitive behavior therapy for obsessive-compulsive disorder and is delivered via an internet platform and regular therapist contact several times per week via email and telephone. The treatment is 12 weeks. Both parents and adolescents are involved in treatment. Parents will also receive three lectures on 1, Autism spectrum disorder, 2, CBT and functional analysis and 3, Parental strategies
16030849|NCT02660086|Behavioral|Personalized nutrition feedback|Automated personalized nutrition feedback about cafeteria food purchases (weekly); social norms and small financial incentives to promote healthy purchases (monthly)
16030850|NCT02660073|Device|NMES+FES|12 weeks of electrically evoked resistance training followed by 12 weeks of functional electrical stimulation cycling.
16030851|NCT02660073|Device|Control+FES|12 weeks of passive movement followed by 12 weeks of functional electrical stimulation cycling.
16030852|NCT02660060|Drug|Pramipexole Dexa Medica|Pramipexole 0.25 tablets produced by PT Dexa Medica for PT Ferron Par Pharmaceuticals as the test drug.
16030853|NCT02660060|Drug|Pramipexole Boehringer Ingelheim Pharma|Pramipexole 0.25 tablets produced by Boehringer Ingelheim Pharma GmbH & Co.KG for Boehringer Ingelheim International GmbH as the reference drug.
16030854|NCT02660047|Drug|Liraglutide|"Drug: Liraglutide
~Preparation and labelling of Investigational Medicinal Product:
~Liraglutide will be packed and labeled by Novo Nordisk A/S and provided in non-subject specific boxes. Labeling will be in accordance with Annex 13, local law and trial requirements. The examples of labels are not readily available, but will be supplied when received from Novo Nordisk.
~Drug accountability:
~Drug accountability will be cared for by the Department of Clinical Pharmacy of the LUMC. The trial product will be dispensed to each subject as required according to treatment group by the clinical pharmacist. No trial product will be dispensed to any person not enrolled in the trial."
16030855|NCT02660047|Drug|Liraglutide - Placebo|"Drug: Liraglutide - Placebo
~Preparation and labelling of Investigational Medicinal Product:
~Liraglutide - Placebo will be packed and labeled by Novo Nordisk A/S and provided in non-subject specific boxes. Labeling will be in accordance with Annex 13, local law and trial requirements. The examples of labels are not readily available, but will be supplied when received from Novo Nordisk.
~Drug accountability:
~Drug accountability will be cared for by the Department of Clinical Pharmacy of the LUMC. The trial product will be dispensed to each subject as required according to treatment group by the clinical pharmacist. No trial product will be dispensed to any person not enrolled in the trial."
16030856|NCT02660034|Biological|tislelizumab|
16030857|NCT02660034|Drug|pamiparib|
16030858|NCT02660008|Drug|ZP4207|Parallel trial in Group 1 and cross-over trial in Groups 2-4 with single doses of ZP4207 administered s.c. to hypoglycemic Type 1 diabetic patients
16030859|NCT02660008|Drug|GlucaGen|Parallel trial in Group 1 and cross-over trial in Groups 2-4 with single doses of GlucaGen administered s.c. to hypoglycemic Type 1 diabetic patients
16030860|NCT02659995|Other|No intervention|No interventions will be performed on these patients.
16030861|NCT02659943|Biological|Anti-cluster of differentiation 19 (CD19)-Chimeric Antigen Receptor (CAR) T cells|Dose-escalation trial starting dose: 0.66x10^6 CAR+ T cells/kg(weight based dosing)(up to a maximum dose of 18x10^6 CAR+ T cells/kg) infuse on day 0
16030862|NCT02659943|Drug|Cyclophosphamide|300 mg/m^2 intravenous (IV) infusion over 30 minutes on days -5, -4 and -3
16030863|NCT02659943|Drug|Fludarabine|30 mg/m^2 intravenous (IV) infusion over 30 minutes administered immediately following the cyclophosphamide on days -5, -4,and -3
16030864|NCT02659930|Drug|liposomal doxorubicin|liposomal doxorubicin IV day 1 of a 28-day cycle
16030865|NCT02659930|Drug|pomalidomide|pomalidomide once a day, days 1- 21 of a 28-day cycle, at the dose levels described in dose escalation plan
16030866|NCT02659917|Other|Glass ionomer|Application of preventive agent
16030867|NCT02659917|Other|Glass ionomer cement|Application of preventive agent
16030868|NCT02659917|Other|-Glass ionomer-|Atraumatic Restorative Treatment
16030869|NCT02659917|Other|-Glass ionomer cement-|Atraumatic Restorative Treatment
16030870|NCT02659904|Other|Less than 2 mm remaining palatal tissue thickness|The greater palatine and incisive nerves were blocked with 2% lidocaine, 1:100,000 epinephrine injection. After preparation of the recipient bed, free gingival graft was harvested using a handle with knife at palatal donor side with acrylic stent guidance.
16030871|NCT02659904|Other|2 mm or more remaining palatal tissue thickness|The greater palatine and incisive nerves were blocked with 2% lidocaine, 1:100,000 epinephrine injection. After preparation of the recipient bed, free gingival graft was harvested using a handle with knife at palatal donor side with acrylic stent guidance.
16030872|NCT02659891|Biological|IVIg|
16030873|NCT02659891|Other|Placebo|
16030874|NCT02659878|Procedure|bleeding, intraventricular and/ or intracerebral hemorrhage.|Patient's age, sex, comorbidities, medications, the exact time point of bleeding, the circumstances of bleeding neurological and cardiological status are recorded, laboratory tests, Transcranial Color Doppler (TCCD), echocardiography and chest X-ray examinations are carried out within 24 hours after the patient is being admitted to the ICU.
16030875|NCT02659865|Drug|Placebo|Administered orally
16030876|NCT02659865|Drug|LY3039478 original formulation|Administered orally
16030877|NCT02659865|Drug|LY3039478 new formulation|Administered orally
16030878|NCT02659852|Procedure|side by side|Stenting generally begins with selective guidewire cannulation into the left and right intrahepatic bile ducts. Self-expandable metallic stent(SEMS) deployment is the conventional method and parallel SEMS can be inserted. SEMS deployment can be performed serially or simultaneously.
16030879|NCT02659852|Procedure|stent in stent|After first SEMS deployment, contralateral placement of a second SEMS through the mesh of the first deployed stent was done and it looks like a Y configuration.
16030880|NCT02659839|Other|Cancer patients admitted to the ICU|There will be no change in the standard ICU treatment.
16033584|NCT02641041|Other|Placebo|single or multiple dose
16030881|NCT02659826|Device|anodal tsDCS|Transcutaneous spinal cord stimulation will be delivered through a direct current (DC) stimulator (NeuroConn Plus, Germany) using a pair of saline-soaked sponge electrodes (35cm²). The active electrode (anode) will be placed between the eleventh and the twelfth thoracic vertebra) and the reference electrode, over the right arm (deltoid muscle). Will be delivered a current intensity of 2.5 milliampere (mA), fade in and fade out of 10 seconds, during 20 minutes.
16030882|NCT02659826|Device|cathodal tsDCS|Transcutaneous spinal cord stimulation will be delivered through a DC stimulator (NeuroConn Plus, Germany) using a pair of saline-soaked sponge electrodes (35cm²). The active electrode (cathode) will be placed between the eleventh and the twelfth thoracic vertebra) and the reference electrode, over the right arm (deltoid muscle). Will be delivered a current intensity of 2.5 mA, fade in and fade out of 10 seconds, during 20 minutes.
16030883|NCT02659826|Device|sham tsDCS|sham transcutaneous spinal cord stimulation will be delivered through a DC stimulator (NeuroConn Plus, Germany) using a pair of saline-soaked sponge electrodes (35cm²). The electrode anode will be placed between the eleventh and the twelfth thoracic vertebra) and the reference electrode, over the right arm (deltoid muscle). Will be delivered a current intensity of 2.5 mA, fade in and fade out of 10 seconds, during only 30 seconds but the volunteers will continue with electrodes montage for 20 minutes.Thus, early sensations (eg. mild to moderate tingling or itch) on stimulation site will be experienced without inducing any modulatory effects.
16030884|NCT02659826|Device|Gait training|It consists of moderate gait training exercise for 20 minutes. To ensure that the exercise will be performed at moderate intensity will be used the 64% - 76% of maximum heart rate (HRmax = 220-age). Heart rate will be monitored every three minutes through a heart polar. In addition will be monitored perceived effort, gait speed and inclination of the treadmill. The Borg scale will be used to evaluate perceived effort. This is an analogue scale graded from 6 (light exercise) to 20 points (exhaustive exercise). Information about the exercise on the treadmill will be noted in the evolution record.
16030885|NCT02659826|Device|High frequency rTMS|Initially, the higher cortical representation area (hotspot) of first right dorsal interosseous (FDI) muscle will be determined through a figure-eight coil connected to the magnetic stimulator (Rapid2, Magstim, UK) held manually and positioned over the scalp (C3 - 10/20 System) at an angle of 45 degrees from the midline pointed to the target muscle (FDI). Thereafter, RMT will be measure. rTMS protocols was based on previous studies. High frequency protocol: 20 hertz (Hz), 90% RMT, 45 trains, 40 stimuli per train, inter interval of 28 seconds, 1800 stimuli. After each rTMS session, presence of adverse effects will be computed.
16030886|NCT02659826|Device|Low frequency rTMS|Initially, the higher cortical representation area (hotspot) of first right dorsal interosseous (FDI) muscle will be determined through a figure-eight coil connected to the magnetic stimulator (Rapid2, Magstim, UK) held manually and positioned over the scalp (C3 - 10/20 System) at an angle of 45 degrees from the midline pointed to the target muscle (FDI). Thereafter, RMT will be measure. Low frequency protocol: 1Hz, 90% RMT, 1500 stimuli (1 train). After each rTMS session, presence of adverse effects will be computed.
16030887|NCT02659826|Device|sham rTMS|The hotspot of first right dorsal interosseous (FDI) muscle will be determinate through a figure-eight coil connected to the magnetic stimulator positioned over the motor primary cortex (C3). Then, the motor threshold (RMT) of FDI will be measure. Sham rTMS will be performed with low frequency (1Hz, 90% RMT, 1500 stimuli) protocol using two coils. The first one - connected to the stimulator - will be positioned on a coil support close to the volunteer but not visible. Therefore, characteristic stimulation noises will be audible. The second - disconnected to the stimulator - will be placed over left primary motor area. After each rTMS session, presence of adverse effects will be computed.
16030889|NCT02659800|Other|Laboratory Biomarker Analysis|Correlative studies
16030890|NCT02659800|Biological|NT-I7|Given IM
16030891|NCT02659800|Other|Placebo|Given IM
16030892|NCT02659787|Drug|0.2mg Buprenorphine|Sublingual buprenorphine tablets (0.2mg)
16030893|NCT02659787|Drug|Placebo|Placebo
16030894|NCT02659774|Behavioral|workshop (Motivational intervention)|Through intensive workshop which includes motivation of quitting enhancement, stress management, smoking triggers, cravings and relapse, to provide smoking cessation intervention
16030895|NCT02659774|Behavioral|Health talk|Health talk provided information about hazards of tobacco (active smoking, second- and third-hand smoke), benefits of quitting smoking and methods to quit smoking
16030896|NCT02659774|Behavioral|Face to Face counseling|Use motivational interview strategies through face-to-face counseling to provide smoking cessation intervention
16030897|NCT02659774|Behavioral|Phone counseling|Use motivational interview strategies through telephone counseling to provide smoking cessation intervention
16030898|NCT02659774|Behavioral|SMS|Use motivational interview strategies through telephone messages to provide smoking cessation intervention
16030899|NCT02659774|Behavioral|Booklet|A 26-page booklet included information about smoking and diseases, benefits of quitting smoking, methods to quit smoking, how to handle withdrawal symptoms, stress management, declaration of quitting smoking, decisional balance of smoking or quitting
16030900|NCT02659761|Drug|dolutegravir/abacavir/lamivudine|600 mg abacavir, 50 mg dolutegravir and 300 mg lamivudine single tablet taken orally, once daily, during 96 weeks
16030901|NCT02659748|Dietary Supplement|Milk Fat|Three daily servings of whole yogurt (3.25% fat).
16030902|NCT02659748|Dietary Supplement|Control Fat|Three daily servings of fat-free yogurt supplemented with a control fat.
16030903|NCT02659735|Drug|JNJ-63623872 300 milligram (mg)|Participants will receive 600 milligram (mg) JNJ-63623872 formulated as the 300 mg oral tablet on Day 1.
16030904|NCT02659735|Drug|JNJ-63623872 600 mg|Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #1 on Day 1.
16030905|NCT02659735|Drug|JNJ-63623872 600 mg|Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #2 on Day 1.
16030906|NCT02659735|Drug|JNJ-63623872 600 mg|Participants will receive 600 mg JNJ-63623872 formulated as 600 mg oral concept formulation #3 on Day 1.
16030907|NCT02659722|Device|InterFuse|TRansforaminal or Posterior placement of an InterFuse S and/or T device, in combination with approved posterior fixation
16030908|NCT02659709|Device|Interest in medical education through social media|Measuring interest in social media technology designed to educate glaucoma patients about disease, testing, and treatments with reminders for taking medications.
16030911|NCT02659657|Drug|Interleukin-2|Interleukin-2 (IL-2), 0.4×10E+6/M2/d, 3 times a week (separated by at least 1 day between injections) until day +90 (+/- 7 days)
16030912|NCT02659644|Drug|Oral L-citrulline|There will be a total of 16 patients divided into 4 equal cohorts. The first 4 cohorts will be started on a 7 day oral regimen of twice daily L-citrulline. They will return to clinic on day #7 to evaluate nitric oxide metabolite levels and pharmacokinetic (PK) profile of citrulline. After PK analysis, the next cohort of patients will be given a higher or lower dose based on their weight and also based safety and tolerability. Of note, a PK analysis will be performed for each 4 patient cohort prior to starting citrulline for the subsequent cohort. Assessment for adverse events will be done at specified times throughout the study duration via both phone and clinic encounters.
16030913|NCT02659631|Drug|PF-06671008|Dose Escalation Phase - Part 1
16030914|NCT02659631|Drug|PF-06671008|Dose Expansion Phase - Part 2
16030915|NCT02659605|Procedure|Delayed cord clamping above the perineum|After delivery, the infant will be placed on the mother's abdomen and the cord will be clamped 30-45 seconds after delivery of the infant.
16030916|NCT02659605|Procedure|Delayed cord clamping below the perineum|The infant will be held below the perineum, and the cord clamped and cut 60-75 seconds after delivery of the infant.
16030917|NCT02659592|Procedure|transplantation of ovarian tissue|operation(mini laparotomy) for transplantation of frozen- thawed ovarian tissue
16030918|NCT02659579|Behavioral|The Reader Organisation's Shared Reading Programme|In The Reader Organisation's Shared Reading Programme, parents and children will attend weekly shared book reading sessions for 8 weeks which focus predominately on how to read interactively with children.
16030919|NCT02659579|Behavioral|Shared Reading control|Parents and children will attend a weekly shared reading group at a library for 8 weeks
16030920|NCT02659553|Procedure|steatosis|Liver Transplantation with graft steatosis
16030921|NCT02659540|Drug|Nivolumab|Nivolumab was administered as an intravenous (IV) infusion over approximately 30 or 90 minutes, with dosing calculated using body weight.
16030922|NCT02659540|Drug|Ipilimumab|Ipilimumab was administered as an IV infusion over approximately 30 or 90 minutes, with dosing calculated using body weight. The ipilimumab infusion was initiated approximately 30 minutes after the end of the nivolumab infusion on applicable dosing days.
16030923|NCT02659540|Radiation|Radiotherapy|RT was delivered in accordance with cohort assignment and institutional practices.
16030924|NCT02659527|Drug|68Ga- PSMA-HBED-CC|Patients will receive a dual-tracer PET/MRI scan. FEC and 68Ga-PSMA-HBED-CC, for tissue metabolism and surface marker expressions, as specific PET-tracers as well as multiparametric MRI methods (T2w, DCE, DWI) are used.
16030925|NCT02659527|Device|Biograph mMR, Siemens|All PET-MRI examinations will be performed using a hybrid PET-MRI system (Biograph mMR, Siemens, Germany) capable of simultaneous data acquisition. The system consists of an MRI-compatible state-of the art PET detector integrated in a 3.0-T whole-body MRI scanner.
16030926|NCT02659514|Drug|Poziotinib|Supplied as oral tablets, administered daily for each 21 days cycle.
16030927|NCT02659501|Drug|Liposomal bupivacaine|Liposomal Bupivacaine is an aqueous suspension of multivesicular liposomes containing bupivacaine. After injection into soft tissue, bupivacaine is slowly released from the multivesicular liposomes, extending this drug's duration of action.
16030928|NCT02659501|Drug|Bupivacaine with epinephrine|Bupivacaine, like other local anesthetics reduces the flow of sodium in and out of nerves. This decreases the initiation and transfer of nerve signals in the area in which the drug is injected. This leads first to a loss of sensation of pain, temperature, touch, and deep pressure. This drug is the current standard of care for local, postoperative local anesthesia following breast reconstruction. Epinephrine, a vasoconstrictor, is included in bupivacaine formulations to improve the duration of local anesthesia.
16030929|NCT02659501|Drug|Morphine sulfate|Morphine is an opiate pain medication administered intravenously for severe, breakthrough post-operative pain.
16030930|NCT02659501|Drug|Hydrocodone/acetaminophen|Hydrocodone acetaminophen is a combination of an opiate pain medication (hydrocodone) and a non-steroidal anti-inflammatory drug (acetaminophen) given orally to patients for moderate post-operative pain.
16030931|NCT02659501|Drug|Diazepam|Diazepam is a benzodiazepine medication that is administered orally to treat muscle spasms in patient's following expander and implant-based breast reconstruction.
16030932|NCT02659488|Drug|Lisdexamfetamine|20 healthy controls and 20 women subjects with BED agreeing to a 12-week, open-label trial of LDX and fMRI assessments immediately before and after the 12 weeks of LDX treatment will be recruited
16030933|NCT02659475|Drug|PHEN/TPM ER (Qsymia®)|PHEN/TPM ER (Qsymia®)
16030934|NCT02659462|Other|Cardio Pulmonary Exercise Testing|Cardio Pulmonary Exercise Testing
16030935|NCT02659449|Device|made to measure compression gloves|Patients achieve tests with compression glove
16030936|NCT02659449|Device|Compression bandaging|Patients achieve tests with compression bandaging
16030937|NCT02659449|Other|Free Hands|Patients achieve tests without device
16030938|NCT02659436|Other|Verbal-linguistic CBT|Participants will receive 4 sessions of individual therapy focused on traditional cognitive restructuring and exposure therapy.
16030939|NCT02659436|Other|Imagery-based CBT|Participants will receive 4 sessions of individual therapy focused on imagery-based cognitive work and behavioural experiments.
16030940|NCT02659423|Behavioral|BIC 1|BIC cluster creation will include policy, implementation and degree of community coverage, specific title mandatory, and exclusively online training.
16030941|NCT02659423|Behavioral|BIC 2|BIC cluster creation will include policy, implementation and degree of community coverage, specific title mandatory, and exclusively online training.
16030942|NCT02659423|Behavioral|BIC 3|BIC cluster creation will include policy, implementation and degree of community coverage, specific title mandatory, and exclusively online training.
16030943|NCT02659410|Other|Heat stress (21)|4h exposure to heat (WBGT of 21°C), no solvent
16030944|NCT02659410|Other|Heat stress (25)|4h exposure to heat (WBGT of 25°C), no solvent
16030945|NCT02659410|Other|Heat stress (30)|4h exposure to heat (WBGT of 30°C), no solvent
16030946|NCT02659410|Other|Heat Stress (21) +TOL|4h exposure to heat (WBGT of 21°C) + Toluene (concentration = TLV)
16030947|NCT02659410|Other|Heat stress (25) + TOL|4h exposure to heat (WBGT of 25°C) + Toluene (concentration = TLV)
16030948|NCT02659410|Other|Heat stress (21) + TOL|4h exposure to heat (WBGT of 30°C) + Toluene (concentration = TLV)
16030949|NCT02659410|Other|Heat stress (21) + ACE|4h exposure to heat (WBGT of 21°C) + Acetone (concentration = TLV)
16030950|NCT02659410|Other|Heat stress (25) + ACE|4h exposure to heat (WBGT of 25°C) + Acetone (concentration = TLV)
16030951|NCT02659410|Other|Heat stress (30) + ACE|4h exposure to heat (WBGT of 30°C) + Acetone (concentration = TLV)
16030952|NCT02659410|Other|Heat stress (21) + DCM|4h exposure to heat (WBGT of 21°C) + Dichloromethane (concentration = TLV)
16030953|NCT02659410|Other|Heat stress (25) + DCM|4h exposure to heat (WBGT of 25°C) + Dichloromethane (concentration = TLV)
16030954|NCT02659410|Other|Heat stress (30) + DCM|4h exposure to heat (WBGT of 30°C) + Dichloromethane (concentration = TLV)
16030955|NCT02659410|Other|Heat stress (21) + TOL (dermal)|4h exposure to heat (WBGT of 21°C) + Toluene (concentration = TLV), participants breath normal air through a mask for evaluation of dermal absorption.
16030956|NCT02659410|Other|Heat stress (25) + TOL (dermal)|4h exposure to heat (WBGT of 25°C) + Toluene (concentration = TLV), participants breath normal air through a mask for evaluation of dermal absorption.
16030957|NCT02659410|Other|Heat stress (30) + TOL (dermal)|4h exposure to heat (WBGT of 30°C) + Toluene (concentration = TLV), participants breath normal air through a mask for evaluation of dermal absorption.
16030958|NCT02659397|Drug|ETC-1002|Blinded ETC-1002 180 mg tablet once daily for 4 weeks (Weeks 1 to 4)
16030959|NCT02659397|Drug|Atorvastatin|Atorvastatin 80 mg tablet once daily for 8 weeks (Weeks -4 to 4)
16030960|NCT02659397|Drug|Placebo|Blinded ETC-1002-matched placebo tablet once daily for 4 weeks (Weeks 1 to 4)
16030961|NCT02659384|Drug|Bevacizumab|
16030962|NCT02659384|Drug|atezolizumab|
16030963|NCT02659384|Drug|acetylsalicylic acid|
16030964|NCT02659384|Drug|placebo|
16030965|NCT02659371|Dietary Supplement|Low energy diet|
16030966|NCT02659358|Device|Fitbit Charge HR®|A wrist worn biosensor, the Fitbit Charge HR® has sensor capability, good battery life, water resistant, Bluetooth capabilities, and provides accessible data.
16030967|NCT02659345|Behavioral|Emotions Thermometer|The Emotions Thermometer, was chosen to assess patients' mood, anxiety level, and pain scale for this study. For patient ease, the study team chose to utilize a scale of 1-10 for all subjective measurements to be obtained from patients (mood and anxiety level). The study team included the thermometer image to mirror the NCCN Guidelines Version Distress Management Screening tool, for measuring distress and mood level. This screening tool has been shown to be effective in assessing patient distress and mood in oncology patients with ease of use in patients and utility in providers.
16030968|NCT02659345|Behavioral|Art Therapy|Each participant will participate in a private art therapy session with the Art Therapist for 50 minutes. The participant will have a choice of materials to work with, including painting, drawing, clay, and collage materials. The session will conclude with processing of the art and supportive counseling.
16030969|NCT02659332|Device|TURBT|Diode laser (400μm fiber, 6-12W, laser pulse 1ms and intervals of 1 ms)
16030970|NCT02659319|Behavioral|Family Lifestyle (FL)|12-week Family Food & Lifestyle intervention, aimed at improving family nutritional intake, activity levels, weight perception, and parental monitoring of child eating. Material is delivered in psychoeducational groups in the children's schools.
16030971|NCT02659319|Behavioral|Family Dynamics (FD)|The Family Dynamics intervention focuses on positive parenting (i.e., emotion coaching, praise, limit setting) and on child emotion regulation and positive problem solving. Material is delivered in psychoeducational groups in the children's schools.
16030972|NCT02659319|Behavioral|Peer Group (PG)|Peer Group intervention conducted throughout one semester of the school year that includes 12 sessions of a guidance-type curriculum during class time sensitizing children to the importance of social inclusion of all children
16030973|NCT02659306|Drug|Metformin|Metformin hydrochloride is a white to off-white crystalline compound formulated as tablets for oral consumption; tablets contain 500 mg, 850 mg, or 1000 mg of metformin hydrochloride. Only 500 mg and 850 mg tablets will be used for this study.
16030974|NCT02659293|Drug|Lenalidomide|"Cycle 1: 15 mg days 1-21
~Cycles 2-4: 25 mg days 1-21 if tolerated, otherwise continue at lower dose
~Cycles 5 and beyond: best tolerated dose days 1-21"
16030975|NCT02659293|Drug|Carfilzomib|"Cycle 1: 20 mg/m2 Days 1, 2; 36 mg/m2 Days 8, 9, 15, 16. Alternatively, intermediate dose escalation (to 27mg/m2 on days 8,9 of cycle 1) will be al12,lowed at the treating physician's discretion.
~Cycle 2-4: 36 mg/m2 if tolerated Days 1, 2, 8, 9, 15, 16
~Cycles 5-8 (patients that are MRD- and have no risk factors at the end of cycle 6) and Cycle 5 - 36 (for MRD+ patients and high risk patients at the end of cycle 6): best tolerated dose Days 1, 2, 15, 16"
16030976|NCT02659293|Drug|Dexamethasone|"Cycles 1 - 4: 20 mg PO or IV per dose Days 1, 8, 15, 22
~Cycles 5+: 20 mg or best tolerated dose PO or IV per dose Days 1, 8, 15, 22"
16030977|NCT02659293|Drug|Lenalidomide (Control)|"Cycles 1-4: Days 1-28. Lenalidomide will begin at a dose of 10 mg PO daily (2 capsules per day). After three months, the dose will be increased, provided ANC ≥ 1,000/µL, platelet count ≥ 75,000/µL, and all nonhematologic toxicity is ≤ grade 1, to 15 mg PO daily (3 capsules per day).
~Cycles 5 and beyond: best tolerated dose days 1-28"
16030978|NCT02659280|Other|Adjunct Therapy|"Store and Forward Tele-heath"
16030979|NCT02659280|Other|Standard of Care|Standard of Care Outpatient Physical Therapy
16030980|NCT02659267|Behavioral|Interventions Group|VAMOS is a lifestyle promotion strategy, designed to promote physical activity and healthy eating habits. The intervention is composed by a weekly meeting, 12-week, in group, lasting about 60 min. In each weekly meeting, were discussed guidelines and strategies for physical activities practices in different domains and for adoption of a healthy diet. All aspects and strategies included in the VAMOS strategy are based in behavior changes theories. The participants of this group received educational material and, in the middle of the program, they received a pedometer to aid in motivation and in the self-monitoring physical activity.
16030981|NCT02659254|Device|Sirolimus Target Eluting Bioresorbable Vascular Scaffold|Implantation of the Sirolimus Target Eluting Bioresorbable Vascular Scaffold
16030982|NCT02659241|Drug|Adavosertib|Given PO
16030983|NCT02659241|Other|Laboratory Biomarker Analysis|Correlative studies
16030984|NCT02659228|Device|EEG recording|EEG recording with anesthetic (DIPRIVAN)
16030985|NCT02659228|Drug|Anesthetics, Intravenous|The participant will receive an intravenous infusion of propofol (DIPRIVAN Injectable Emulsion USP 1%, AstraZeneca).
16033585|NCT02641028|Drug|CERC-501|CERC-501
16030986|NCT02659215|Device|Hyalofast|Implantation of Hyalofast scaffold with autologous bone marrow aspirate concentrate via arthroscopy/mini-arthrotomy.
16030987|NCT02659215|Procedure|Microfracture|Microfracture is a well-established arthroscopic surgical technique for cartilage repair which involves several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect, with resultant complete defect fill by a well-anchored clot
16030988|NCT02659202|Device|Precision Spinal Cord Stimulator System|The precision system will consist of a pulse generator that will not be implanted, temporary percutaneous leads, surgical paddle leads and lead extensions, each packaged as a separate kit.
16030989|NCT02659176|Procedure|Transperineal repair with PIS|Repair of anterior rectocele via transperineal approach followed by limited internal sphincterotomy at 6 o'clock.
16030990|NCT02659176|Procedure|Transperineal repair without PIS|Repair of anterior rectocele via transperineal approach without performing limited internal sphincterotomy
16030991|NCT02659163|Behavioral|mHealth wristband|A wristband containing several sensors worn by participants to collect daily objective patient-generated health behavior data on physical activity, sleep, and screen time
16030992|NCT02659163|Behavioral|mHealth scale|A wireless scale used by participants to measure and record daily weight.
16030993|NCT02659163|Behavioral|EMA|Self-reported information on sugar sweetened beverage consumption collected via mobile messaging
16030994|NCT02659163|Behavioral|mHealth app|A mobile application that houses study data and provides two-way messaging between the study team and study participants.
16030995|NCT02659163|Behavioral|Health Behavior Feedback|Provide feedback on patient-generated health behaviors data, along with standard of care recommendations, for self-guided
16030996|NCT02659163|Behavioral|Integrated closed-loop feedback system|Daily feedback and weekly e-report cards on patient-generated longitudinal health behaviors along with clinical recommendations via mobile messaging
16030997|NCT02659150|Drug|tocilizumab|subjects will be treated with 162mg of weekly subcutaneous tocilizumab in an open-label manner, this will be done addition to MTX or monotherapy. On subsequent weeks after the first dose of tocilizumab, subjects will be instructed to inject the full amount of syringe according to the directions provided in the Instructions For Use (IFU).
16030998|NCT02659137|Other|HV measurement|Electrophysiology (EP) study during the TAVI procedure
16030999|NCT02659124|Device|AmnioFix plus Standard of Care|Patients will receive the standard of care alone on half of their face, and AmnioFix in addition to the standard of care on the other half of their face. The standard of care after ablative resurfacing is conservative wound care which may include flexible wound care dressings and/or emollients.
16031000|NCT02659124|Procedure|Standard of Care|Patients will receive the standard of care dressing only, on their face. The standard of care after ablative resurfacing is conservative wound care which may include flexible wound care dressings and/or emollients.
16031001|NCT02659111|Other|High Intensive Functional Exercise (HIFE)|Patients invited to high-intensity physical exercise, HIFE by a physiotherapist with special competence in neurology at one of the two centers, or by a general physiotherapist where the patient lives. Goal Attainment Scaling is performed. The training will be given twice a week for one hour during 12 weeks . At least 18 of 24 training session in a four month period of time will be required. A training manual will be distributed to each training physiotherapist. The patients will also be encouraged to do additional training and they will receive standardized written physical training advice
16031002|NCT02659111|Other|Physical training advice|Patients randomized to written advice for physical training will be given a leaflet with instructions how to train by there own.The physiotherapist responsible for evaluating sets goals together with the patient according to Goal Attainment Scaling.
16031003|NCT02659098|Drug|CNTO 2476 3.0 x 10^5 cells|Participants will receive a single subretinal administration of CNTO 2476 3.0 x 10^5 cells in 50 microliter (mcL) given by subretinal Delivery System.
16031004|NCT02659098|Device|Subretinal Delivery System|Participants will receive CNTO 2476 by using the Delivery System.
16031005|NCT02659085|Drug|Ketamine IV Infusion|Patients randomized to the experimental treatment receive intravenous infusions of racemic ketamine (0.5 mg/kg), delivered over a period of forty minutes thrice weekly (Monday, Wednesday, Friday) under supervision.
16031006|NCT02659085|Procedure|ECT|ECT given in line with standard procedures (including anesthesia, muscle relaxation and oxygenation) thrice weekly.
16031007|NCT02659059|Biological|Nivolumab|Specified Dose on Specified Days
16031008|NCT02659059|Biological|Ipilimumab|Specified Dose on Specified Days
16031009|NCT02659059|Drug|Platinum Doublet Chemotherapy|
16031010|NCT02659033|Drug|ceftriaxone|ceftriaxone (1 gram per day)
16031011|NCT02659033|Drug|Cefotaxime|cefotaxime (1 gram every 8 hours)
16031016|NCT02659007|Other|yoga|8 weeks of yoga, twice a week. sitting, standing, and floor postures with meditation and breath work
16031017|NCT02658994|Behavioral|Thinking Healthy Program Peer Delivered Plus|
16031018|NCT02658994|Other|Enhanced Usual Care|
16031019|NCT02658981|Biological|Anti-LAG-3 Monoclonal Antibody BMS 986016|Given IV
16031020|NCT02658981|Biological|Anti-PD-1|Given IV
16031021|NCT02658981|Other|Pharmacological Study|Correlative Studies
16031022|NCT02658981|Other|Laboratory Biomarker Analysis|Correlative Studies
16031023|NCT02658981|Biological|Anti-CD137|Given IV
16031024|NCT02658968|Drug|Betalutin|Dose finding study, starting on 10 MBq/kg b.w. Betalutin® (lutetium (177Lu)-lilotomab satetraxetan), single injection with lilotomab pre-dosing.
16031025|NCT02658955|Procedure|Short stitch|Surgeons will receive instructions to change the technique of abdominal wall closure
16031026|NCT02658942|Procedure|Ureteroscopy|In Group A patients, Karl Storz Flex-X 7.5, FURS with a 365 µm laser fiber.
16031027|NCT02658942|Procedure|Shockwave lithotripsy|In Group B patients, a Siemens Lithostar Lithotriptor
16031028|NCT02658929|Biological|bb2121|bb2121
16031029|NCT02658916|Drug|BIIB092|Same dose as corresponding CN002003 study panel.
16031359|NCT02656667|Device|cycle ergometer training|quadriceps strenghthening with cycle ergometer training
16031030|NCT02658903|Device|Oxys Catheter|The study catheter is inserted over the urethra in the bladder as a foley catheter. The study foley catheter delivers electromagnetic therapy.
16031031|NCT02658903|Device|Covidien Mona-Therm Foley catheter|The control arm catheter is inserted over the urethra in the bladder. The control catheter is a Mona-Therm catheter from Covidien.
16031035|NCT02658877|Drug|Omalizumab|Omalizumab will be dosed according to dosing and U.S. administration guidelines for omalizumab. Omalizumab will be dosed every 2-4 weeks based on the patient's pre treatment serum IgE level (IU/mL) and initial visit body weight (kg). Omalizumab will be delivered as a subcutaneous injection. Standard safety precautions for dosing will be observed, including clinical observation after dosing, and provision of an epinephrine pen. Maintenance asthma treatment will remain unchanged.
16031036|NCT02658877|Drug|Placebo|Saline with a volume of injection frequency indicated based on the patient's serum IgE and body weight, delivered subcutaneously and supplied by Novartis Pharma.
16031037|NCT02658864|Drug|lafutidine|comparison of different doses, sex and medication conditions
16031038|NCT02658851|Device|J-Plasma|Bovie Medical Corporation's J-Plasma® helium based plasma technology is a hemostatic tool for the cutting, coagulation, and ablation of soft tissue.
16031039|NCT02658838|Drug|Ticagrelor|Patients were treated with full amount low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.
16031040|NCT02658838|Drug|full amount low molecular weight heparin|Patients were treated with half amount low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.
16031041|NCT02658838|Drug|half amount low molecular weight heparin|Patients were treated with half amount low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.
16031042|NCT02658838|Drug|No low molecular weight heparin|Patients were treated with no low molecular weight heparin randomly after PCI,All patients are treated with ticagrelor one year.
16031043|NCT02658825|Drug|JNJ-63623872 2400 milligram (mg)|Participants will receive JNJ-63623872 2400 mg tablet orally once on Day 1 of Panel 1.
16031044|NCT02658825|Drug|JNJ-63623872 3000 mg|Participants will receive JNJ-63623872 3000 mg tablet orally once on Day 1 of Panel 1.
16031045|NCT02658825|Drug|JNJ-63623872|Participants will receive JNJ-63623872 dose selected in Panel 1 tablet orally once on Day 1 of Panel 2.
16031046|NCT02658825|Drug|Moxifloxacin|Participants will receive moxifloxacin 400 mg capsule orally once on Day 1 of Panel 2.
16031047|NCT02658825|Drug|Placebo (Matching with JNJ-63623872 2400 mg)|Participants will receive placebo (matching with JNJ-63623872 2400 mg) tablet orally once on Day 1 of Panel 1.
16031048|NCT02658825|Drug|Placebo (Matching with JNJ-63623872 3000 mg)|Participants will receive placebo (matching with JNJ-63623872 3000 mg) tablet orally once on Day 1 of Panel 1 and 2.
16031049|NCT02658825|Drug|Placebo (Matching with JNJ-63623872 Dose)|Participants will receive placebo (matching with JNJ-63623872 dose) tablet orally once on Day 1 of Panel 2.
16031050|NCT02658825|Drug|Placebo (Matching with Moxifloxacin)|Participants will receive placebo (matching with Moxifloxacin) tablet orally once on Day 1 of Panel 2.
16031051|NCT02658812|Other|Laboratory Biomarker Analysis|Correlative studies
16031052|NCT02658812|Biological|Talimogene Laherparepvec|Given IT
16031053|NCT02658799|Drug|cataflam (diclofenac potassium)|Cataflam (diclofenac potassium, 50 mg) b.i.d. after a meal for 6 months in a cyclic regimen. Administration of diclofenac potassium was undertaken from baseline to 2 months, no drug (diclofenac potassium or placebo) was administered from 2 to 4 months, then diclofenac potassium or placebo therapy was reinstituted (b.i.d.) from 4 to 6 months. To promote compliance, each patient was recalled monthly.
16031054|NCT02658799|Drug|placebo|"Placebo gel caps (containing inactive filler of starch flour and carboxymethylcellulose) b.i.d. after a meal for 6 months in a cyclic regimen.
~Administration of placebo was undertaken from baseline to 2 months, no drug (diclofenac potassium or placebo) was administered from 2 to 4 months, then diclofenac potassium or placebo therapy was reinstituted (b.i.d.) from 4 to 6 months. To promote compliance, each patient was recalled monthly."
16031055|NCT02658773|Drug|lidocaine-Prilocaine cream|
16031056|NCT02658773|Drug|placebo cream|
16031057|NCT02658760|Drug|Dexmedetomidine|dexmedetomidine plus placebo
16031058|NCT02658760|Drug|Bupivacaine|dexmedetomidine and Bupivacaine
16031059|NCT02658747|Other|No intervention|No intervention administered in this study
16031060|NCT02658734|Drug|Trastuzumab emtansine|3.6 mg/kg intravenously (IV) over 30-90 minutes on day 1 of 21 day cycle, repeated every 3 weeks
16031061|NCT02658721|Drug|Lidocaine|
16031062|NCT02658721|Drug|lidocaine+adjunct tramadol|IVRA was performed with 3 mg/kg lidocaine (10% Lidocaine) plus 50 mg tramadol, which were administered after diluting with saline to 40 mL. While performing IVRA, 30 mL saline was simultaneously administered to the systemic circulation
16031063|NCT02658721|Drug|lidocaine+systemic tramadol|IVRA was performed with 3 mg/kg lidocaine, which was diluted with saline to 40 mL. While performing IVRA, 50 mg tramadol diluted with saline to 30 mL was simultaneously administered to the systemic circulation
16031064|NCT02658721|Drug|Fentanyl|If the patient had a VAS score of >4 and if required, 1 μg/kg fentanyl was administered for analgesia and the dosage and time were recorded.
16031065|NCT02658721|Drug|Atropine|"The patients received premedication 45 min before the surgery with intramuscular 0.01 mg/kg atropine.
~In case of bradycardia (HR <50/min), 0.5 mg intravenous atropine was administered."
16031066|NCT02658721|Drug|Midazolam|The patients received premedication 45 min before the surgery with intramuscular 0.07 mg/kg midazolam
16031067|NCT02658721|Drug|Diclofenac sodium|The patients with a VAS score of >4 were administered with 75 mg diclofenac sodium via intramuscular route.
16031068|NCT02658721|Drug|Ephedrine|In the event of hypotension (systolic arterial pressure <90 mmHg or a decrease of more than 50 mmHg from the normal value) during the surgery, 5 mg intravenous ephedrine was administered.
16031069|NCT02658721|Drug|Ondansetron|Intravenous 4 mg ondansetron was administered for nausea and vomiting.
16031070|NCT02658708|Other|Bright blue-green light using light visor cap|
16031071|NCT02658708|Other|Dim red light using light visor cap|
16031360|NCT02656667|Other|Conventional pulmonary rehabilitation|excercise training on treadmill
16031072|NCT02658708|Other|European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire|-Consists of 30 items with a 4-point rating scale (1=not at all to 4=very much) measuring functioning, symptom intensity, and global health status/quality of life
16031073|NCT02658708|Other|Epworth Sleepiness Scale|-Consists of 8 common daily activities with a 4-point rating scale (0=would never doze to 3=a high chance of dozing) measuring usual daytime sleepiness over a recent time period
16031074|NCT02658708|Other|Pittsburgh Sleep Quality Index|-Contains 19 self-report items measuring sleep quality, latency, duration, efficiency, disturbance, medication use, and daytime dysfunction. Each item is rated on a 0-3 rating scale. The global PSQI score ranges 0-21, with higher scores indicating more severe sleep disturbance
16031075|NCT02658708|Other|Patient-Reported Outcomes Measurement Information System (PROMIS)-Sleep Disturbance|-Consists of 8 items with 5-point rating scales measuring overall sleep and sleep-related impairments. Higher scores indicate worse sleep disturbances
16031076|NCT02658708|Other|Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer-Fatigue|-Consists of 8 items with a 5-point rating scale (1=not at all to 5 =very much) measuring fatigue experience and fatigue impact. Higher scores indicate worse fatigue.
16031077|NCT02658708|Diagnostic Test|Digital foot candle datalogging light meter (Extech Instrument, Model SDL400)|-The light-weight light sensor is approximately 2 inches in diameter and comes with a clip and strap that makes it comfortable to wear just below the neck.
16031078|NCT02658708|Diagnostic Test|Polysomnography (Easy Ambulatory 2 Cadwell, Kennewick, WA)|-A standard sleep montage of electroencephalography following the 10/20 procedure for electrode placement, left and right electrooculography referenced to the opposite mastoid and mentalis electromyography will be followed
16031079|NCT02658708|Other|Horne-Ostberg Morningness-Eveningness Questionnaire|
16031080|NCT02658708|Other|Daily Fatigue and Sleep Log|"Two visual analog scales (VAS) for diurnal fatigue and daytime sleepiness
~Two 0-10 point rating scales (average and worst fatigue levels in 24 hours)"
16031081|NCT02658682|Behavioral|Attention Bias Modification|Computer based Attention Bias Modification
16031082|NCT02658682|Behavioral|Sham Attention Bias Modification|Computer based Sham Attention Bias Modification
16031083|NCT02658669|Behavioral|Cognitive-Behavioral Therapy for Insomnia|Intervention includes strategies designed to improve sleep such as: sleep restriction, stimulus-control techniques, sleep hygiene education, and relaxation training.
16031084|NCT02658669|Behavioral|Sleep Education|Intervention includes sleep hygiene education and education regarding the impact of TBI on sleep.
16031086|NCT02658643|Procedure|Continuous suture technique|The BDA is performed as continuous suture with two separate all-layer suture for the behind - and front-wall of the anastomosis
16031087|NCT02658643|Procedure|Interrupted suture technique|The BDA is performed as interrupted suture with two separate all-layer suture for the behind - and front-wall of the anastomosis
16031088|NCT02658630|Device|Robot + TTT exercise|The intervention will be completed 36 visits approximately 3x/week for 12-18 weeks. The training progression will be sequential with 12 visits completed on the wrist robot, followed by 12 visits on the shoulder-elbow robot and completing with 12 visits alternating sessions on the wrist and shoulder-elbow robot. Participants will perform robot training for 45 minutes with each robot followed by 15 minutes of TTT practice to complete their 60 minute intervention session.
16031089|NCT02658604|Other|Home medication review by a pharmacist|Patients will receive a home visit from a pharmacist, including a medication review and the identification and addressing of drug therapy problems through patient education, the provision of pharmacologic and/or non-pharmacologic advice, or the adaptation of therapy or communication of recommendations to prescribers. All activities are within the current scope of practice for pharmacists in Ontario. A detailed assessment of the patient's medication inventory and organization/storage practices will be conducted, followed by a medication cabinet cleanup to help the patient organize their medications and discard any expired or discontinued medications. A list of inappropriate medications found in the home will be documented, detailing the reasons why they are inappropriate and if/how the patient is currently using these medications. With patient consent, inappropriate medications will be removed from the home and returned to the pharmacy for safe disposal.
16031090|NCT02658591|Dietary Supplement|Crackers/pasta with added faba bean protein concentrate|Protein concentrate treatment
16031091|NCT02658591|Dietary Supplement|Crackers/pasta with added faba bean protein isolate|Protein isolate treatment
16031092|NCT02658591|Dietary Supplement|Crackers/pasta with added faba bean starch|Starch treatment
16031093|NCT02658591|Dietary Supplement|Crackers/pasta with added faba bean flour|Flour treatment
16031094|NCT02658591|Dietary Supplement|Crackers/pasta with no faba bean fraction|Control treatment
16031095|NCT02658578|Procedure|PNS|Active PNS will be administered by 2 pairs of surface electrodes (cathode proximal). One pair will overly the median and ulnar nerves at the wrist, and the other pair will overly the radial nerve. Trains of electric stimulation will be delivered at 1 Hz by using isolation units connected to a square pulse stimulator. In sham PNS, the median, ulnar and radial nerves will not be actively stimulated.
16031096|NCT02658565|Procedure|Lymphadenectomy|Lymphadenectomy recommended, including: obturator, iliac (internal, external, common) and aortic lymph nodes
16031097|NCT02658552|Device|Echopulse|Echopulse is a real-time US-guided High-intensity focused ultrasound (HIFU) system, the HIFU session is a noninvasive procedure that involves application of a focused high-energy ultrasound beam for thermal tissue ablation inside the targeted zone, with minimal effect on the surrounding tissue
16031098|NCT02658526|Behavioral|anesthesia - surgery|
16031099|NCT02658513|Other|Lancet blood sampling|Blood samples will be obtained using a finger-prick (lancet) technique.
16031100|NCT02658513|Other|Standard intravenous blood sampling|Blood samples will be obtained using a standard intravenous technique.
16031101|NCT02658500|Dietary Supplement|Infant Formula|
16031102|NCT02658500|Dietary Supplement|breast milk|
16031103|NCT02658487|Drug|Cytarabine|Given IV
16031104|NCT02658487|Drug|Vosaroxin|Given IV
16031105|NCT02658474|Behavioral|Acceptance and Commitment Therapy|Group based Acceptance and Commitment Therapy
16031219|NCT02657681|Device|sham|A non-magnetic metal cylinder, with the same size, weight and appearance of the magnet, will be used for sham stimulation (MAG45s; Neurek SL, Toledo, Spain).
16031106|NCT02658461|Drug|Trastuzumab|Trastuzumab will be given on Day 1 of each 3-week cycle for a total of 18 cycles. Dosage will be according to the local labeling: 600 milligrams (mg) SC or 6 milligrams per kilogram (mg/kg) via IV infusion. For those assigned to the IV arm or if IV treatment is delayed >1 week, an initial loading/reloading dose of 8 mg/kg will be given instead. Due to the observational nature of this study, trastuzumab is not an investigational product but will be supplied in the MO22982 trial. Each route/device (SC single-use injection device, SC vial/syringe, IV infusion) will be observed in at least 12 episodes of care.
16031107|NCT02658448|Drug|GTx-024|GTx-024 softgel capsules will be administered once-daily to a total dose of 3 mg
16031108|NCT02658435|Drug|Tafenoquine 150 mg|Tablet contains TQ as tafenoquine succinate. The 2 tablets (2 tablets of 150mg) of dark pink, capsule-shaped, film coated will be administered orally with 240ml of water.
16031109|NCT02658435|Drug|Matched placebo 150mg|It is the matched Placebo tablet. The 2 tablets (2 tablets of 150mg) of dark pink, capsule-shaped, film coated will be administered orally with 240ml of water.
16031110|NCT02658422|Drug|Test Montelukast|Test Montelukast (GW483100) is available as round, biconvex, pink 10 mg film-coated tablet (containing montelukast sodium equivalent to 10 mg of montelukast) and is administered as a single dose with 240 mL of water.
16031111|NCT02658422|Drug|Reference Montelukast|Reference Montelukast (innovator product) is available as pale beige, rounded square shaped,10 mg film-coated tablet (containing montelukast sodium equivalent to 10 mg of montelukast) and is administered as a single dose with 240 mL of water. Singular is the innovator product used for this study, which is a trade name owned by Merck Sharp and Dohme Corporation.
16031112|NCT02658409|Biological|GC3106(quadrivalent cell-culture based influenza vaccine)|GC3106(quadrivalent),0.5ml, intramuscular, a single dosing at Day 1
16031113|NCT02658409|Biological|Fluarix™tetra Syringe Inj.(quadrivalent influenza vaccine)|Fluarix™tetra Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1
16031114|NCT02658396|Drug|GO-203-2C|
16031115|NCT02658396|Drug|Bortezomib|
16031116|NCT02658383|Other|Cleaner cookstove received after visit 2|The participants will change from a traditional wood burning cookstove to a cleaner burning (wood) cookstove called the JUSTA (after visit 2).
16031117|NCT02658383|Other|Cleaner cookstove received after visit 4|The participants will change from a traditional wood burning cookstove to a cleaner burning (wood) cookstove called the JUSTA (after visit 4).
16031118|NCT02658370|Device|animated home-based exercises (Wii-fit)|
16031119|NCT02658370|Procedure|conventional home-based exercise program|
16031120|NCT02658357|Drug|Risperidone Implant|
16031121|NCT02658344|Biological|JOINTSTEM|Jointstem (Autologous Adipose Tissue derived MSCs 1x10^8cells/3ml), 1 time injection
16031122|NCT02658344|Drug|Saline solution|Saline solution (Sodium chloride 9mg/ml), 1 time injection
16031123|NCT02658292|Drug|Naftifine hydrochloride foam, 3%|Apply NAFT900 foam twice daily to the affected area(s) plus half-inch around each affected area for 4 weeks
16031124|NCT02658292|Drug|Vehicle|Apply vehicle foam twice daily to the affected area(s) plus half-inch around each affected area for 4 weeks
16031125|NCT02658279|Drug|Pembrolizumab|
16031126|NCT02658266|Behavioral|Home based resistance training|The participants in the intervention group will receive an individualized resistance training program. The individual adjustments in load will will be made from the results of the muscle function and muscle strength tests. The resistance training will be home based and performed 3 times per week 10-12 reps 2 sets 12 weeks. Increment of load will be performed continuously according to rating of perceived exertion.
16031127|NCT02658253|Biological|PRIMVAC|3 different dosages of VAR2CSA protein (20µg - 50µg and 100µg)
16031128|NCT02658253|Biological|GLA-SE|2.56 µg of GLA content
16031129|NCT02658253|Biological|Alhydrogel|0.85 mg og Aluminium content
16031130|NCT02658253|Biological|Placebo|0.9% Na cl
16031131|NCT02658240|Drug|Ropivacaine|Ropivacaine 300 mg and 0.5 mg epinephrine diluted to 60 mL
16031132|NCT02658240|Drug|Epinephrine|0.5 mg epinephrine
16031133|NCT02658214|Drug|paclitaxel + carboplatin|IV infusion
16031134|NCT02658214|Drug|carboplatin + etoposide|IV infusion
16031135|NCT02658214|Drug|gemcitabine + carboplatin|IV infusion
16031136|NCT02658214|Drug|nab-paclitaxel (paclitaxel-albumin) + carboplatin|IV infusion
16031137|NCT02658214|Drug|oxaliplatin + 5-fluorouracil (5FU) + leucovorin (calcium folinate/folinic acid)|IV infusion and bolus administration
16031138|NCT02658214|Biological|durvalumab|IV infusion
16031139|NCT02658214|Biological|tremelimumab|IV infusion
16031140|NCT02658214|Drug|nab-paclitaxel (paclitaxel-albumin) + gemcitabine|IV infusion
16031141|NCT02658214|Drug|cisplatin + 5-fluorouracil (5FU)|IV infusion
16031142|NCT02658201|Device|MRI|Ultrafast MRI to assess constipation
16031143|NCT02658188|Drug|ASP8825|Oral
16031144|NCT02658175|Drug|Volanesorsen|300 mg volanesorsen administered via SC injection.
16031145|NCT02658162|Drug|SANGUINATE|Two (2) infusions of 320 mg/kg of SANGUINATE at Baseline and Day 1
16031146|NCT02658162|Drug|Normal Saline|Two (2) infusions of Normal Saline at an equal volume to SANGUINATE at Baseline and Day 1.
16031147|NCT02658149|Drug|Ropivacaine with NaCl|50 mL (40 mL of 0.2% Ropivicaine and 10 mL of 0.9% NaCl) are administered into the psoas compartment
16031148|NCT02658149|Drug|Epinephrine|"0.15 mg Epinephrine are injected as part of the drug cocktail"
16031149|NCT02658149|Drug|Morphine|"4 mg Morphine are injected as part of the drug cocktail"
16031150|NCT02658149|Drug|Ketorolac Tromethamine|"30 mg morphine are injected as part of the drug cocktail"
16031151|NCT02658149|Drug|Ropivacaine|"30 mL 0.5% Ropivicaine are injected as part of the drug cocktail"
16031152|NCT02658136|Other|Cardiac Computed tomography|
16031153|NCT02658123|Other|Pre-operative education (standard of care)|
16031154|NCT02658123|Other|Home health care visits (standard of care)|
16031155|NCT02658123|Other|Follow-up post-operative visits|
16031156|NCT02658123|Other|Patient Data Collection Form|-Form that contains date, area to record number of pouches, and if home health care visit took place.
16031157|NCT02658123|Other|Healthcare Utilization Form|"Form for patient to record if they visited an emergency room or urgent care or if they were hospitalized
~Form allows patient to record reason for visit and date of visit"
16031158|NCT02658123|Other|The City of Hope QOL Survey for Ostomy Patients|"Consists of 47 questions asking various physical, psychological, sexual, work-related, and demographic questions.
~Additional 34 questions on how the ostomy affects quality of life. Answers range from 0=not at all to 10=severe problem."
16031159|NCT02658123|Other|Phone call with CWOCN or PA|
16031160|NCT02658110|Dietary Supplement|Whey Protein|20 g whey protein isolate (Arla Foods Ingredients Group) added to 200ml water and served as a beverage
16031161|NCT02658110|Other|Mixed Macronutrient Breakfast Meal|A standardised mixed-macronutrient breakfast served to all participants. The macronutrient distribution of the breakfast is 13% protein, 70% carbohydrate, 17% fat (1958 kJ; 468 kcal total)
16031162|NCT02658110|Other|Mixed Macronutrient Lunch Meal|A standardised mixed-macronutrient lunch served to all participants. The macronutrient distribution of the lunch is 14% protein, 51% carbohydrate, 35% fat (3506 kJ; 838 kcal total)
16031163|NCT02658097|Drug|Pembrolizumab|200mg Pembrolizumab by IV infusion
16031164|NCT02658097|Radiation|Single Fraction Radiation Therapy|8Gy radiation therapy will be given in a single fraction on the first day of treatment
16031165|NCT02658084|Drug|Vinorelbine|Administered as an intravenous infusion on Day 1 and Day 8 of every 21-day cycle.
16031166|NCT02658084|Drug|Trastuzumab Emtansine|Administered as an intravenous infusion on Day 1 of every 21-day cycle.
16031167|NCT02658058|Other|Landmark technique|The site of needle insertion will be determined via manual palpation. A line joining the superior aspect of the iliac crests posteriorly (Tuffier's line') will be used as a surface landmark for the L4 vertebral body. The midline will be established by palpation of the tips of the spinous processes, and the site of needle insertion will be marked on the patient's skin. The interspace that appears widest, based on manual palpation, will be chosen for the first attempt. If the first attempt is unsuccessful, further attempts can be made at the same interspace or another interspace.
16031168|NCT02658058|Other|Ultrasound-guided paramedian technique|The transducer will be applied in the parasagittal plane and the intervertebral levels will be identified by counting upwards from the sacrum (continuous hyperechoic line). The probe will then be angled obliquely to obtain a PSO view. The locations of the interlaminar spaces will be identified by visualizing the ligamentum flavum-dura mater complex and the posterior aspect of the vertebral body. The angulation at which the ligamentum flavum-dura mater complex and posterior vertebral body are best visualized will be considered the optimal angle for needle insertion and clearly communicated to the operator. The interlaminar space will be centered on the ultrasound screen and a skin marker will be used to make a mark on the patient's back at the middle of the ultrasound probe.
16031169|NCT02658058|Other|Ultrasound-guided midline technique|The transducer will be applied in the parasagittal plane, and after identification of the intervertebral levels, the probe will be rotated 90 degree to obtain the TM view. The transducer is moved in a cephalad-caudad direction between the spinous processes of L2 and L5 vertebra. The probe will be tilted slightly up and down to ensure a sufficient echogenic window at the selected intervertebral space. A skin marker will be used to make a mark on the patient's back at the middle of the ultrasound probe. The angle at which the ligamentum flavum-dura mater complex and the posterior aspect of the vertebral body are best visualized will be noted
16031170|NCT02658045|Device|Standard Oximeter|Oxygen saturation will be measured by standard oximeter
16031171|NCT02658045|Device|Oxitone oximeter|Oxygen saturation will be measured by Oxitone oximeter
16031172|NCT02658032|Behavioral|personalized cessation care|Individuals randomized to this condition will receive standard care (i.e., 5 counseling sessions and nicotine patch(NRT)) and 4 personalized videos with 5 packages of personalized print materials
16031173|NCT02658032|Behavioral|bio feedback|Individuals randomized to this group will be provided with a personalized graph of their biomarker data from baseline, 6 and 8 weeks at the 8-week and 3-month study visits.
16031174|NCT02658032|Other|standard care|
16031175|NCT02658019|Drug|Pembrolizumab|Patients will be treated in three-week cycles, with intravenous (IV) administration of 200 mg of pembrolizumab on day 1 of each 3-week cycle.
16031176|NCT02658006|Procedure|Cardiac surgery|All cardiac surgery procedures
16031177|NCT02657993|Behavioral|Hypnosis|"The hypnosis intervention involves three parts. First, participants will receive three, face-to-face hypnosis sessions delivered by doctoral-level psychology professionals. The sessions are based on materials developed by experienced psychologists in the Integrative Behavioral Medicine Program at the Icahn School of Medicine at Mount Sinai. Second, participants will be taught how to use hypnosis themselves (self-hypnosis) to help manage their pain. Third, participants will receive a hypnosis recording to listen to in-between sessions and throughout the course of the study. At home hypnosis practice will be recommended.
~Participants will be asked to complete questionnaires over a period of 12 months."
16031178|NCT02657993|Behavioral|Attention Control|"The attention control intervention involves three face-to-face meetings with a doctoral-level psychology professional. During these sessions, participants will be asked to discuss with the interventionist their experience of taking aromatase inhibitors and associated musculoskeletal pain. The interventionist will not lead the patient in imagery, relaxation, evaluation of thought processes, or even simple discussion. Rather interventionists will allow the patient to direct the flow of the conversation and will provide support and empathy. Interventionist contact time in AC sessions will be identical to that in the hypnosis group. Overall, the attention control intervention will control for professional attention.
~Participants will be asked to complete questionnaires over a period of 12 months."
16031179|NCT02657980|Device|Yband(YDT-201N)|transcranial Direct Current Stimulation (tDCS) 2mA for 30 min; 30 sec of ramp-up and -down; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)
16031180|NCT02657980|Device|Sham-Yband(YDT-201N)|transcranial Direct Current Stimulation (tDCS) 2mA for 30 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)
16031181|NCT02657954|Behavioral|CCT|10-week Compensatory Cognitive Training
16031182|NCT02657954|Behavioral|HCE|10-week Holistic Cognitive Education
16031183|NCT02657941|Behavioral|Motivational group|"Three weekly sessions of one hour, co-managed by two nurses specialized in psycho-education
~Session 1: General information on the risk of weight gain and the means of prevention, motivational balance on the practice of physical activity, developing a personal goal, information about the sports center Session 2: brainstorming and card game on Food Hygiene Session 3: Find situations at risk of snacking and consider alternative lines"
16031259|NCT02657356|Drug|Bardoxolone methyl capsules|
16031260|NCT02657343|Drug|Ribociclib|
16031184|NCT02657941|Behavioral|educational group|"Three weekly sessions of one hour, co-managed by two nurses specialized in psycho-education
~Session 1: General information on the risk of weight gain and means of prevention, video on physical activity, discussions with therapists, information about the sports center Session 2: Video on Food Hygiene, discussions with therapists Session 3: Return on basic concepts covered in the first 2 sessions"
16031188|NCT02657915|Drug|Placebo|Administered as specified in the treatment arm.
16031189|NCT02657915|Drug|BIIB033 100mg/Kg|Administered as specified in the treatment arm.
16031190|NCT02657902|Procedure|Fractures were treated with a Gamma 3 intramedullary nail|
16031191|NCT02657902|Procedure|Fractures were treated with a Gamma 3 intramedullary nail + U-Blade|
16031194|NCT02657876|Biological|ExpressGraft-C9T1 Skin Tissue|ExpressGraft-C9T1 skin tissue is provided as a suturable, biologically-active, circular skin tissue with a fully-stratified epithelial compartment comprised of human keratinocytes (NIKSC9T1) and a dermal compartment containing fibroblasts
16031195|NCT02657863|Procedure|Urine collection and blood draw|
16031196|NCT02657850|Other|non- head and neck self reporting|non- head and neck patient self reports dysphagia symptoms
16031197|NCT02657850|Other|head neck self reporting|head and neck patient self reports dysphagia symptoms
16031198|NCT02657850|Other|provider reporting|provider reports on head and neck cancer patients' dysphagia symptoms
16031199|NCT02657824|Other|dyspneic patients|measuring mitral valve and septal distance in acute dyspneic patients for estimating left ventricular ejection fraction
16031200|NCT02657811|Device|Miri, Benchtop Multi-room incubator|Bench Incubation - Morphologic Assessment These embryos will undergo multiple evaluations using light microscopy and traditional morphologic assessment.
16031201|NCT02657811|Device|Miri TL, Time-Lapse incubator|Time Lapse Incubation - Morphologic/Morphokinetic Assessment These embryos will remain in the TLI and undergo both morphologic and morphokinetic evaluation and grading according to a hierarchical multivariable model. They will not be removed from incubation for the duration of culture.
16031202|NCT02657811|Device|Miri TL, Time-Lapse incubator|Time Lapse Incubation - Morphologic Assessment These embryos will remain in the TLI and undergo only traditional morphologic assessment according to accepted criteria with no additional imaging. They will also not be removed from incubation for the duration of culture. The time points and evaluated parameters will be identical to those in arm 1 of the study.
16031203|NCT02657785|Drug|R-IDARAM plus intrathecal chemotherapy|R-IDARAM comprised of rituximab 375 mg/m2 (day 1), idarubicin 10 mg/m2(day 2 and 3); dexamethasone 100 mg/m2 (12 h.infusion in day 2, 3 and 4); cytarabine 1 g/m2 (1 h. infusion in day 2 and 3); methotrexate 2 g/m2 (6 h. infusion in day 4 with folinic acid rescue). Intrathecal Immunochemotherapy comprised of rituximab 10mg, MTX 15mg, dexamethasone 5mg and Ara-c 50mg once a week.
16031204|NCT02657759|Dietary Supplement|CARDICHOL|
16031205|NCT02657759|Dietary Supplement|PLACEBO|
16031206|NCT02657746|Other|multi-component interventions|The multi-component interventions (MCI) is comprised of all the following five components: 1) home health education (HHE) by government community health workers (CHWs), plus 2) blood pressure (BP) monitoring and stepped-up referral to a trained general practitioner (GP) using a checklist, plus 3) training public and private providers in management of hypertension and using a checklist, plus 4) designating hypertension triage counter and hypertension care coordinators in government clinics, plus 5) a financing model to compensate for additional health services and provide subsides to low income individuals with poorly controlled hypertension.
16031207|NCT02657733|Device|Radical-7|"Comparison between 3 different monitors that measure respiratory rate. The participant is connected to 3 monitors at the same time.
~Radical-7- measures respiratory rate according to acoustic respiratory rate (RRa)."
16031208|NCT02657733|Device|Nellcor™ Bedside Respiratory Patient Monitoring System|"Comparison between 3 different monitors that measure repiratory rate. The participant is connected to 3 monitors at the same time.
~Nellcor™ Bedside Respiratory Patient Monitoring System - measures respiratory rate according to oximetry respiration rate (RRoxi)."
16031209|NCT02657733|Device|Capnostream 20p|Comparison between 3 different monitors that measure respiratory rate. The participant is connected to 3 monitors at the same time. Capnostream 20p- measures respiratory rate according to Capnography (RRetco2).
16031210|NCT02657720|Device|Radical 7|Comparison between 3 different monitors that measure respiratory rate. The participant is connected to 3 monitors at the same time. Radical 7 measures respiratory rate according to acoustic respiratory rate (RRa).
16031211|NCT02657720|Device|Capnostream20p|Comparison between 3 different monitors that measure respiratory rate. The participant is connected to 3 monitors at the same time. Capnostream20p measures respiratory rate using capnography (RRetCO2).
16031212|NCT02657720|Device|PTAF2|Comparison between 3 different monitors that measure respiratory rate. The participant is connected to 3 monitors at the same time. PTAF2 measures respiratory rate using flow pressure (RRflow).
16031213|NCT02657707|Device|Roadsaver™ Carotid Artery Stent Device|The Roadsaver™ carotid artery stent system is indicated for use in patients with significant atherosclerotic disease of the carotid arteries.
16031214|NCT02657707|Device|Nanoparasol® Embolic Protection System|The Nanoparasol® embolic protection system is indicated for use with a guidewire to contain and remove embolic material (thrombus/debris) while performing angioplasty and stenting procedures in carotid arteries.
16031215|NCT02657694|Drug|Sofosbuvir+Ledipasvir|DAA medication treatment
16031216|NCT02657694|Drug|Sofosbuvir+Daclatasvir|DAA medication treatment
16031217|NCT02657694|Drug|Sofosbuvir+Velpatasvir|DAA medication treatment
16031218|NCT02657681|Device|tSMS|Transcranial static magnetic field stimulation (tSMS) is a non-invasive brain stimulation (NIBS) technique that decreases cortical excitability. Static magnetic fields suitable for tSMS are obtained with commercially available neodymium magnets. We will use a cylindrical neodymium magnet of 45 mm diameter and 30 mm of thickness, with a weight of 360 g (MAG45r; Neurek SL, Toledo, Spain), which will be applied with south polarity to the motor cortex, over the representational field of hand area contralateral to the more affected side of the body.
16031261|NCT02657343|Drug|T-DM1|
16031262|NCT02657343|Drug|Trastuzumab|
16031220|NCT02657668|Behavioral|Emotion Focused Therapy|EFT was conducted in eight sessions (without pretest and posttest sessions) according to Greenberg's manual (22) in a clinic of gastrointestinal patients. According to Greenberg manual, EFT consists of three steps: 1) emotional awareness 2) accessing healthy emotions 3) skills of emotional intelligence. There were five individuals in the posttest (because of being absent more than three sessions or not participating in the posttest).
16031221|NCT02657655|Device|Kinesia 360|Kinesia 360 includes a mobile app and wireless motion sensors worn on the patient's wrist and ankle to quantify tremor, dyskinesias, and mobility throughout the day as he or she goes about normal activities. The app includes electronic diaries enable patients to rate their symptoms and log when medications are taken. Data is transferred to a cloud server where motor symptom reports are generated for clinician review.
16031222|NCT02657629|Other|Continuous Feeding Regimen|Nocturnal continuous enteral feedings given from 8pm-8am with intermittent bolus feedings every 3 hours between 11am and 5pm. Continuous feedings given via gavage (nasogastric tube, orogastric tube or gastrostomy tube) and intermittent bolus feeds via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d.
16031223|NCT02657629|Other|Intermittent Bolus Feeding Regimen|Intermittent bolus enteral feedings given after 3 hours for entire 24 hours period. Feedings given via gavage or nipple. Total caloric intake maintained at 120-130 kcal/kg/d.
16031224|NCT02657616|Drug|vitamin-k-antagonists|
16031225|NCT02657616|Drug|Novel oral anticoagulants|
16031226|NCT02657603|Drug|Lidocaine|Lidocaine injected through the new Catheter (LAX)
16031227|NCT02657603|Drug|Lidocaine|Lidocaine injected through the new Catheter (SAX)
16031228|NCT02657603|Procedure|LAX insertion of catheter|ultra sound guided cather insertion in the long axis (LAX) of the adductor canal
16031229|NCT02657603|Procedure|SAX insertion of catheter|ultra sound guided cather insertion in the short axis (SAX) of the adductor canal
16031230|NCT02657577|Other|There is no intervention|There is no intervention
16031231|NCT02657564|Drug|Polyethylene glycol (PEG)|Participants receive blood tests for serum creatinine and electrolytes (Ca, P, Cl, Mg, Na, K) before and after taking polythylene glycol.
16031232|NCT02657551|Drug|Regorafenib|Regorafenib is a small molecule inhibitor of multiple membrane-bound and intracellular kinases involved in normal cellular functions and in pathologic processes.
16031233|NCT02657538|Other|Non invasive caries treatment|If the active comparator does not detect cavitation, fluoride varnish is applied on the test surface.
16031234|NCT02657538|Other|Invasive caries treatment|If the active comparator does detect cavitation, a composite restauration is placed
16031235|NCT02657538|Device|Near-infrared light transillumination device (DIAGNOcam, KaVo, Biberach, Germany)|
16031236|NCT02657538|Other|Visual examination and bitewing (BW) radiography|established diagnostic methods
16031237|NCT02657512|Drug|rivaroxaban|rivaroxaban 40 mg/day (1 day)
16031238|NCT02657512|Drug|rivaroxaban and activated charcoal|rivaroxaban 40 mg/day (1 day) and 50 g of activated charcoal 2 or 5 or 8 hours after rivaroxaban administration (1 day)
16031239|NCT02657499|Other|Medicaid Expansion|There will be no direct intervention, but rather an observation of change based on whether a state expanded Medicaid or not
16031240|NCT02657486|Drug|BGJ398|
16031241|NCT02657473|Drug|tobramycin inhalation solution|
16031242|NCT02657473|Drug|Saline 0.9% inhalation solution|
16031243|NCT02657460|Biological|tumor derived microparticles|The main difference between the two treatment groups is the biological coat, which is tumor derived microparticles.
16031244|NCT02657460|Drug|cisplatin|cisplatin is a traditional drug for lung cancer
16031245|NCT02657447|Drug|Betalutin with lilotomab dose 1|15 MBq/kg b.w. Betalutin (lutetium (177Lu) lilotomab satetraxetan) single injection, with lilotomab pre-dosing, dose 1
16031246|NCT02657447|Drug|Betalutin with lilotomab dose 2|15 MBq/kg b.w. Betalutin (lutetium (177Lu) lilotomab satetraxetan) single injection, with lilotomab pre-dosing, dose 2
16031247|NCT02657434|Drug|Atezolizumab|Participants received IV infusion of 1200 mg atezolizumab on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period and until disease progression on Day 1 q3w in the maintenance dosing period.
16031248|NCT02657434|Drug|Carboplatin|Participants received IV infusion of carboplatin on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period with doses calculated using Calvart formula.
16031249|NCT02657434|Drug|Cisplatin|Participants received IV infusion of 75 mg/m^2 cisplatin on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period.
16031250|NCT02657434|Drug|Pemetrexed|Participants received IV infusion of 500 mg/m^2 pemetrexed on Day 1 q3w for 4 or 6 cycles (Cycle length=21 days) in induction dosing period and until disease progression on Day 1 q3w in the maintenance dosing period.
16031251|NCT02657421|Procedure|Oblique Lateral Interbody Fusion|The oblique lateral interbody fusion (OLIF) procedures at L2-L5 (OLIF25™) and L5-S1 (OLIF51™) is a minimally invasive surgical option for degenerative lumbar disease. This approach allows for psoas-preserving access to the lumbar spine and minimizes the need to reposition the patient during surgery for accessing additional spinal levels for the interbody fusion portion of the procedure
16031252|NCT02657408|Drug|BI 1026706|
16031253|NCT02657408|Drug|Placebo|
16031254|NCT02657395|Device|PriMatrix|Use of PriMatrix under a coronal positioned flap to obtain root coverage.
16031255|NCT02657382|Behavioral|Heart Rate Variability (HRV) Biofeedback (BF)|Heart Rate Variability (HRV) biofeedback involves deep breathing, mindfulness (focusing on one's emotions and thoughts) and cognitive therapy (identifying and changing unhelpful or inaccurate thinking and distressing emotional responses). It is a 6-week training with one hour sessions with a certified biofeedback coach once per week. A handheld personal stress reliever device will be provided to the patients to practice at home for 20 minutes a day.
16031256|NCT02657382|Other|Mental Stress Protocol|Mental stress will consist of a 3-min math serial subtraction paradigm.The participants will be asked to serially subtract 7 from number specified by the researcher. For participants who have difficulty with this task, easier serial subtraction will be provided for. Throughout the task, to increase stressfulness and titrate difficulty, the participant will be prompted for faster performance and the starting number from which they were subtracting will be periodically changed. Finally, to add an evaluation component, participants will be given negative feedback during the test.
16031257|NCT02657369|Drug|Lenvatinib 24 mg|
16031258|NCT02657356|Drug|Placebo capsules|
16031265|NCT02657317|Behavioral|FORT-A|FORT-A is based on a functional restoration paradigm of pain management in which treatment is interdisciplinary and designed to achieve a functional goal (often specified by the patient; e.g., doing more with family, returning to work). FORT-A includes intensive functional rehabilitation, group-based pain management intervention, and individual interventions tailored to the patient's specific needs (e.g., biofeedback for stress, individual psychotherapy for mood or trauma symptoms).
16031266|NCT02657317|Other|VA Treatment as Usual|VA TAU includes referrals for specialty intervention, rehabilitation, and behavioral health intervention within the VA medical system. Some participants may be referred for care outside of the VA system. The South Texas Veterans Health Care System offers a wide range of pain management services.
16031267|NCT02657304|Behavioral|Coaching group|patients will have a medical consultation at 2 weeks post-diagnostic and one phone call/month for duration of 5 months. The consultations will use visual support, CPAP device and its accessories.
16031268|NCT02657304|Other|Control group|patients receive only usual care (standard), it's mean: diagnosis with explanation of the disease and benefit of CPAP, entrusts a medical device provider, then an appointment proposed by the doctor or taken by the patient (5 months).
16031269|NCT02657291|Drug|Ropivacaine|Local anesthetic
16031270|NCT02657291|Device|Ultrasound|Ultrasound guided block
16031271|NCT02657278|Procedure|Arterial Revascularization surgery or Endovascular procedure|Symptoms limited Cardiopulmonary Exercise Test (CPET) performed before and four weeks after surgical or endovascular correction of peripheral arterial disease
16031272|NCT02657265|Device|SpineJack system|Spine fracture management for traumatic vertebral compression fracture
16031273|NCT02657265|Device|Conservative management|Surgical corset according to measurement's impression, rigid corset with sternal support
16031274|NCT02657252|Drug|Glucose|Sclerotherapy of telangiectasis in one lower limb.
16031275|NCT02657252|Drug|Polidocanol with Glucose|Sclerotherapy of telangiectasis in one lower limb.
16031276|NCT02657239|Behavioral|MOVE UP|Weight management behavioral program
16031277|NCT02657213|Device|Minimed 640G with smartguard activated|Patients will be equipped with a Minimed 640G insulin pump coupled with Enlite sensor with SmartGuard activation
16031278|NCT02657213|Device|Minimed 640G with smartguard off|Patients will be equipped with Minimed 640G insulin pump coupled with Enlite glucose sensor without SmartGuard activation
16031279|NCT02657200|Other|survey|questionnaire assessing the knowlegde, attitude and practices regarding spontaneous abortion
16031280|NCT02657187|Device|Inbody|Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Inbody, Seoul, Korea) after fast for eight hours.
16031281|NCT02657187|Drug|Rocuronium|The individual dose method was used for the determination of the dose response of rocuronium. After induction of anesthesia, four groups of 40 patients each received randomly one of the four doses of rocuronium ( 0.24, 0.32, 0.40, 0.48mg/muscle mass(kg))
16031282|NCT02657174|Device|low level laser in auricular acupuncture points|40 third molars surgeries will be performed in a conventional manner. At the end of surgery, low level laser will be applied at auricular points for prevention of inflammation and pain in the immediate post-operative period (baseline).The operator will mark the points that will be irradiated on the outer atrium of the patient with red gel pen to avoid interference with red laser (λ = 660 nm). The low level laser points will be irradiated in the same operated side.
16031283|NCT02657174|Device|low level laser device off in auricular acupuncture points|40 surgeries will be performed in the conventional manner, identically to the G1. The patient will receive low level laser with a protection of lead in the laser nozzle, in order to block the passage of light, in the same auricular points used in G1.
16031284|NCT02657161|Biological|RABIPUR®|Biological rabies vaccine
16031285|NCT02657161|Biological|PIKA rabies vaccine|Biological rabies vaccine
16031286|NCT02657161|Biological|PIKA rabies vaccine with an accelerated regimen|Biological rabies vaccine
16031287|NCT02657148|Drug|Nexplanon (etonogestrel contraceptive implant)|Nexplanon is a single, radiopaque, rod-shaped implant, containing 68 mg etonogestrel indicated for postpartum contraceptive use by women to prevent pregnancy. Nexplanon is designed to be effective for 3 years.
16031288|NCT02657148|Drug|Standard postpartum contraceptive care|Condoms, Depo Provera (DMPA) or progestin-only pills initiated at any time after delivery, Nexplanon insertion at > 4 weeks after delivery, combined hormonal contraception (e. g. pills, patch, ring) initiated at any time > 4 weeks after delivery or levonorgestrel-intrauterine system or copper IUD insertion any time > 6 weeks after delivery.
16031289|NCT02657135|Behavioral|Cognitive/Neuropsychological Testing|These tests will be used to determine how the participant will continue with future procedures, and depending on results, may involve the participant returning to complete subsequent testing.
16031290|NCT02657135|Other|Vestibular/Ocular-Motor Testing|These assessments will involve a series of tests and questionnaires that focus on physical symptoms of TBI and will include dizziness, balance, ocular-motor coordination, and reflexes.
16031291|NCT02657135|Other|Cervical (Neck) Evaluation|These assessments will involve a series of tests and questionnaires that focus on physical symptoms of TBI including neck mobility and pain levels.
16031292|NCT02657135|Other|Sleep Evaluation|These evaluations will focus on assessing insomnia (duration, frequency, daytime consequences), combat exposure, and the presence and severity of trauma history.
16031293|NCT02657135|Other|HDFT MRI|This MRI aims at providing qualitative and quantitative assessments of the nature, location, and extent of white matter injury.
16031294|NCT02657135|Other|MR Spectroscopy (MRS)|This is a noninvasive diagnostic test for measuring biochemical changes in the brain.
16031295|NCT02657135|Other|MEG (Magnetoencephalography)|This is a non-invasive neurophysiological technique that measures the magnetic fields generated by neuronal activity of the brain.
16031296|NCT02657122|Drug|TD-1473 for SAD|SAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 5 dose ascending cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally as a single dose.
16031297|NCT02657122|Drug|Placebo for SAD|SAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 5 dose ascending cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally as a single dose.
16031361|NCT02656654|Other|Whole-body compression|
16031298|NCT02657122|Drug|TD-1473 for MAD|MAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 4 cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally for a total of 14 days of dosing.
16031299|NCT02657122|Drug|Placebo for MAD|MAD: Healthy subjects meeting eligibility criteria will be sequentially randomized to each dose cohort (up to 4 cohorts) to receive either TD-1473 or placebo. The study drug (TD-1473 or placebo) will be administered orally for a total of 14 days of dosing.
16031300|NCT02657109|Other|physical therapy procedure|physiotherapy exercises conducted in early way for the rehabilitation of patients in the postoperative period of cardiac valve replacement.
16031301|NCT02657096|Procedure|Hybenx treatment (device)|In the maxillary quadrant assigned to SRP + hybenx treatment, hybenx was applied, after SRP, on the gingiva with a 30-second incubation period and then thoroughly rinsed away through abundant irrigation with a sterile saline solution.
16031302|NCT02657096|Procedure|Scaling and Root Planing (SRP)|The contra-lateral quadrants were treated as conventional Scaling and Root Planing (SRP) alone.
16031303|NCT02657083|Device|DreaMed Substance Administration Device|"2 exercise days under DreaMed MD-AID control with afternoon exercise (in the time between 16:30 and 19:30).
~New infusion set and two continuous glucose sensors (one for back-up) will be inserted in the subcutaneous tissue of the arm and then calibrated the day before each visit from 3 to 6.
~The continuous glucose sensor continuously will measure interstitial glucose levels and these values will be sent by the Minilink™ via wireless, low-powered, radio frequency to the Paradigm Veo every 5 minutes for up to 6 days.
~The DreaMed MD-AID uses a vendor-supplied and self-developed (communication module) communication application programming interface (API) in order to retrieve glucose / insulin data from the Paradigm Veo and set insulin treatment according to the algorithm decision."
16031304|NCT02657083|Device|Sensor Augmented Pump (SAP)|"2 exercise days under Sensor Augmented Pump with afternoon exercise (in the time between 16:30 and 19:30).
~New infusion set and two continuous glucose sensors (one for back-up) will be inserted in the subcutaneous tissue of the arm and then calibrated the day before each visit from 3 to 6.
~The continuous glucose sensor continuously will measure interstitial glucose levels and these values will be sent by the Minilink™ via wireless, low-powered, radio frequency to the Paradigm Veo every 5 minutes for up to 6 days.
~During the exercise the group will turn off the insulin pump and lower their basal insulin for 20% for the next 4 hours after the exercise"
16031305|NCT02657070|Behavioral|Reinforcement-Induced Movement Therapy (RIMT)|6 weeks, 1 session a day, 30min per sessions, of physical therapy using a VR rehabilitation gaming system (RGS) with augmented visuomotor feedback
16031306|NCT02657070|Behavioral|VR-based motor rehabilitation in RGS without augmented feedback|6 weeks, 1 session a day, 30min per sessions, of physical therapy using a VR rehabilitation gaming system (RGS)
16031307|NCT02657057|Device|PTNS|The needle and electrode are connected to a low voltage (9 V) electrical stimulator (URO stim2). Stimulation current with a fixed frequency of 20 Hz and a pulse width of 200 msec is increased until flexion of the big toe or fanning of all toes becomes visible, or until the subject reports a tingling sensation across the heel or bottom of the foot.
16031308|NCT02657057|Device|TENS SNS|Electrodes are connected to a low voltage (9 V) electrical stimulator (URO stim2). Stimulation current with a fixed frequency of 20 Hz and a pulse width of 200 msec is increased until flexion of the big toe or fanning of all toes becomes visible, or until the subject reports a tingling sensation across the heel or bottom of the foot.
16031309|NCT02657044|Procedure|EMR|
16031310|NCT02657044|Procedure|ESD|
16031311|NCT02657031|Drug|Prochlorperazine|prochlorperazine 10 mg IV
16031312|NCT02657031|Drug|Ketamine|Ketamine 0.3 mg/kg IV
16031313|NCT02657031|Drug|Diphenhydramine|Diphenhydromine 25 mg IV
16031314|NCT02657031|Drug|Ondansetron|Ondansetron 4 mg IV
16031315|NCT02657031|Drug|Normal Saline|Normal Saline 500 cc IV Bolus
16031316|NCT02657018|Device|MOBIGAME|Mobile phone based game-like software application and platform (MOBIGAME) that includes individualized and structured exercise regimens (endurance, strength, balance and flexibility) that are based on the user's individual fitness evaluation (through established fitness tests) and incorporated into the story line of a gardening simulation game.
16031317|NCT02657018|Other|Control|One-time standard lifestyle counseling including the promotion of baseline activities of daily life as well as a structured exercise plan including strength and endurance exercises with moderately increasing intensity and duration that is to be implemented autonomously.
16031318|NCT02657005|Drug|TK216|Inhibitor of protein-protein interactions of EWS-FLI1 fusion protein
16031319|NCT02656992|Device|Inspiratory muscle training group|
16031320|NCT02656979|Drug|Latanoprost|Between measurements on day 1 and day 2, the subjects will receive a drop of latanoprost which is an IOP lowering drug once daily in one eye.
16031321|NCT02656966|Device|Auricular acupuncture|"Five ear acupuncture points: MA-IC, MA-TF1, MA-SC, MA-AT1 and MA-TG will be needled bilaterally in patients, who will wish to receive AA. Indwelling fixed New Pyonex needles (length: 1.5 mm, diameter: 0.22 mm; Seirin Corp., Shizuoka City, Japan) will be used for AA."
16031322|NCT02656953|Device|VDU lenses (Zeiss® Officelens Plus)|The treatment group (n=22) was given progressive VDU glasses (Zeiss® Officelens Plus), specially designed for VDU work. The participants were asked to wear their new glasses for six months during computer work.
16031323|NCT02656953|Device|Progressive lenses (Zeiss® Multifocal Precision Plus)|The comparison group (n=18) was given progressive glasses (Zeiss® Multifocal Precision Plus). The participants were asked to wear their new glasses for six months during computer work.
16031324|NCT02656940|Dietary Supplement|Group 1 - diet rich in n-3 and n-6 PUFA|In order to achieve the desired intake of unsaturated FA, the group received individual portions of vegetable oils in the form of sachets, which were consumed for lunch and dinner, besides gelatin capsules, for 60 days.
16031325|NCT02656940|Dietary Supplement|Group 2 - diet rich in MUFA|In order to achieve the desired intake of unsaturated FA, the group received individual portions of vegetable oils in the form of sachets, which were consumed for lunch and dinner, besides gelatin capsules, for 60 days.
16031326|NCT02656940|Dietary Supplement|Group 3 - Placebo group|Placebo group was instructed to keep their eating habits and consuming placebo for 60 days.
16031327|NCT02656927|Behavioral|Yoga Condition|
16031328|NCT02656914|Drug|Irlanda-2-Association|Take 10 mL every 12 hours (2x/day), oral route.
16033586|NCT02641028|Drug|Placebo|Placebo
16031330|NCT02656901|Device|auto total endovenous anesthesia|a closed-loop controller guided by the BIS steering the infusion pumps (Alaris Medical UK Ldt, Hants, Uk) as already approved by ClinicalTrials.gov Identifier: NCT00392158
16031331|NCT02656901|Device|Manual Desflurane anesthesia|General anesthesia will be maintained with desflurane (Baxter D-Vapor Desflurane Vaporiser) to obtain a BIS value as close as possible to 50 and between 40
16031332|NCT02656901|Device|Manual Sevoflurane anesthesia|General anesthesia will be maintained with sevoflurane ( Baxter Vapour 2000 Sevoflurane Vapouriser) to obtain a BIS value as close as possible to 50 and between 40 and 60.
16031333|NCT02656901|Device|Manual total endovenous anesthesia|In ManualTIVA group, the anesthesia will be maintained with propofol (Injectomat TIVA Agilia, Fresenius Kabi, Bad Hamburg, Germany) to obtain a BIS value as close as possible to 50 and between 40 and 60.
16031334|NCT02656888|Drug|Irlanda-1-Association|For children 2 to 6 years old: take 2,5 mL every 12 hours (2x/day), oral route. For children 6 to 12 years old: take 5 mL every 12 hours (2x/day), oral route. For children 12 to 17 years old: take 10 mL every 12 hours (2x/day), oral route.
16031335|NCT02656888|Drug|Placebo|For children 2 to 6 years old: take 2,5 mL every 12 hours (2x/day), oral route. For children 6 to 12 years old: take 5 mL every 12 hours (2x/day), oral route. For children 12 to 17 years old: take 10 mL every 12 hours (2x/day), oral route.
16031336|NCT02656875|Drug|TRV130|
16031337|NCT02656862|Other|No intervention|
16031338|NCT02656849|Drug|BAY 1000394|
16031339|NCT02656836|Other|Home tonometry, diagnostic study|Evaluating intraocular pressure
16031340|NCT02656823|Device|ANKYLOS C/X 6.6 mm|
16031341|NCT02656810|Drug|Teriparatide|Single subcutaneous injection
16031342|NCT02656797|Drug|Topical Amphotericin-B 0.4% liposomal gel|Topical Amphotericin-B 0.4% liposomal gel
16031343|NCT02656784|Behavioral|Cognitive Therapy|Trial-Based Cognitive Therapy (TBCT) is a three-level, three-phase, case formulation approach. TBCT's foundation is in cognitive therapy (CT); however, it has a unique approach to conceptualization and techniques that make it a distinct intervention in modifying patients' core beliefs, especially those about the self. All the individuals will be submitted to MRI.
16031344|NCT02656784|Behavioral|Behavioral Therapy|The Behavioral therapy employs the technique of Exposure and Response Prevention ( ERP ).The technique involves directly exposing patients to recall stimulation of obsessive thoughts and prevent them from performing the compulsive rituals. All the individuals will be submitted to MRI.
16031345|NCT02656771|Device|Echo Bi-Metric|The insertion of the Echo® Bi-Metric® THA stem
16031346|NCT02656758|Behavioral|intensive Executive function training|Children diagnosis of attention deficit hyperactivity disorder are randomized to the experimental condition(Executive Function training) or waiting group experimental:participants will receive 12 sessions of intensive executive function training weekly no intervention :waiting participants will not be treated with intensive executive function training and keep waiting for 12 weeks for comparison
16031347|NCT02656745|Device|Mobile Smoking Cessation Solution|"The intervention regimen is almost entirely user-directed; users will download the application on their iPhones & engage with it throughout their quit journey. They will be asked to complete missions, daily activities to help prepare them to quit and keep them off cigarettes. When they have a craving, a series of options are available to ease the craving and resist the urge to smoke. Daily and Weekly Check-Ins are scheduled by the user to gather information about their smoking habits, help them learn about their addiction, and ultimately to overcome it. Ideally, the user will open and use the program several times a day. Participants who continue with the study through its completion will spend a total of 8 weeks using this smoking cessation mobile program."
16031348|NCT02656732|Biological|amnion chorion allograft membrane|Biologic Amnion chorion allograft membrane derived from placenta of a donor pregnant subject.
16031349|NCT02656732|Procedure|coronally advanced flap with the subepithelial connective tissue graft|coronally advanced flap with the placement of subepithelial connective tissue graft harvested from the palate
16031350|NCT02656719|Device|Ultrasound guided percutaneous tracheostomy|Ultrasound guided percutaneous tracheostomy
16031351|NCT02656719|Device|Bronchoscopy guided percutaneous tracheostomy|Bronchoscopy guided percutaneous tracheostomy
16031352|NCT02656706|Drug|Ipilumumab|
16031353|NCT02656706|Drug|Nivolumab|
16031354|NCT02656693|Behavioral|Online weight management program|Patients who are enrolled in one of the two arms using the online weight management program (BMIQ) will complete structured educational sessions, follow specific calorie goals and meal plans, participate in self-monitoring activities (i.e., regular tracking of weight, diet, and physical activity), and interact with other features of the program.
16031355|NCT02656693|Behavioral|Population health management support|Patients will receive weight-related population health management support from their primary care practice; their online weight management program data will be monitored by the population health manager, who will conduct outreach with patients at designated points according to the protocol.
16031356|NCT02656680|Behavioral|FB + Friends|Participants will receive a weight loss intervention delivered in an online context. The online coaches will post daily content, respond to questions, address concerns, and encourage engagement. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet. For this arm, the study team will keep recruitment open for this condition to allow enrollment of new participants through week 8.
16031357|NCT02656680|Behavioral|FB Only|Participants will receive a weight loss intervention delivered in an online context. The online coaches will post daily content, respond to questions, address concerns, and encourage engagement. The weight loss intervention is based on the Diabetes Prevention Program (DPP), an evidence-based weight loss program focused on lifestyle changes. The goals for the intervention are 175 minutes of moderate physical activity per week and an overall weight loss of 7%. Each participant will get an individualized calorie goal that would facilitate a 1-2 lbs. weight loss weekly. Participants will also be encouraged to use an app such as MyFitnessPal to track daily diet.
16031358|NCT02656667|Device|neuromuscular electrical stimulation|quadriceps strenghthening with neuromuscular electrical stimulation (medical device)
16031498|NCT02655627|Other|Physical activity counselling via a brochure|
16031362|NCT02656641|Behavioral|Continuous Client Feedback|Clients complete rating scales before each therapy session. The therapist then views these results and discusses treatment progress with the client during the session.
16031363|NCT02656641|Behavioral|Continuous Self Feedback|Clients complete rating scales before each therapy session. Progress is not reviewed with the therapist.
16031364|NCT02656628|Device|Dynamic Locking Screw 3.7mm and 5.0mm|Treatment with DLS and locked plate constructs (small or large fragments)
16031365|NCT02656615|Drug|abiraterone acetate|Abiraterone acetate 1000 mg once daily and Prednisone 2x5 mg daily (continuously as per prescription label).
16031366|NCT02656602|Other|Computer Assisted Instruction|The computer assisted instruction consisted of a platform using video mimicking the patient journey with voice-over supported by photo's, 3D animation and instructive texts. The video was presented in short clips, maximal 45 seconds, to maintain the focus of patient. Patient interaction was ascertained by mandatory mouse-click after each item in the CAI. All elements of informed consent for colonoscopy (risks, alternatives) were included.
16031367|NCT02656589|Drug|Capecitabine|Capecitabine will be administered orally at a dose of 2500mg/m2 daily for 3 months (Day 1 to 14 of a 21-day cycle)
16031368|NCT02656589|Drug|Trastuzumab|patients will receive herceptin intravenous infusion at a dose of 6mg on day 1 of each cycle
16031369|NCT02656576|Procedure|Tonsil Biopsy|Biopsies were obtained during endoscopy of Aero-Digestive Tract Superior under general anesthesia.
16031370|NCT02656576|Procedure|Smear|The smears are made in consultation a fortnight before performing endoscopic examination. They are carried out after a local anesthetic spray in order to optimize the number of cells collected.
16031371|NCT02656563|Radiation|Radium 223 Dichloride (Xofigo®)|Radium 223 Dichloride (Xofigo®) monthly for six months
16031372|NCT02656550|Procedure|Uterine Transplant|Transplant of a uterus from either a living donor or a deceased donor.,
16031373|NCT02656537|Device|EnSite™ HD Grid Catheter mapping system|
16031374|NCT02656524|Drug|Regorafenib (Stivarga, BAY73-4506)|Product is used in accordance with SmPC
16031375|NCT02656511|Drug|Dolutegravir|Dolutegravir 50 mg PO daily
16031376|NCT02656511|Drug|Emtricitabine/Tenofovir|Emtricitabine 200 mg/Tenofovir alafenamide 25 mg PO daily
16031377|NCT02656498|Drug|[18F]THK-5351|Imaging for evaluating the accumulation of abnormal tau protein in the brain
16031378|NCT02656485|Drug|B244|10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days
16031379|NCT02656485|Drug|Placebo|10 pumps (1.4 ml) of spray must be applied BID twice a day to the entire face for 14 days
16031380|NCT02656472|Drug|Tranexamic acid|"TXA Loading dose: 31 mg/kg diluted to 2 ml/kg NS (in syringe)
~31 x _______kg = _______ mg TXA (max: 930mg)
~2 x _______ kg = _______ ml NS (max: 60 ml)
~TXA infusion: 14 mg/kg hour = 1 ml/kg/hour (6 hour bag) (Max rate of infusion = 30ml/hr)
~14 x ______ kg = _____mg x 6 = ______ mg TXA (max: 2,520mg)
~1 x ______ kg = _______ml x 6 = ______ ml NS (max: 180ml)
~TXA second bolus in 1 ml/kg NS
~< 16 kg: TXA 45 mg in 1 ml/kg NS = _______ml NS
~16-30 kg: TXA 90 mg in 1 ml/kg NS = _______ml NS
~> 30 kg: TXA 120 mg 1 ml/kg NS = _______ml NS (max 30ml)"
16031381|NCT02656472|Drug|Epsilon Aminocaproic Acid|"Aminocaproic acid Loading dose: 75 mg/kg diluted to 2 ml/kg NS
~75 x _______kg = _______ mg EACA (max: 2,250mg)
~2x _______ kg = _______ ml NS (max 60ml)
~Aminocaproic acid infusion: 75 mg/kg hour = 1 ml/kg/hour (6 hour bag)
~75 x ______ kg = _____mg x 6 = ______ mg EACA (max: 13,500 mg)
~1 x ______ kg = _______ml x 6 = ______ ml NS (max: 180ml)
~Aminocaproic acid second bolus: 75 mg/kg in 1ml/kg NS
~75 x _______kg = _______ mg EACA (max: 2,250mg)
~1 x _______ kg = _______ ml NS (max 30 ml)"
16031382|NCT02656459|Other|11-gene set|This trial is NOT interventional. The 11-gene set / Sepsis MetaScore will be tested post-hoc.
16031383|NCT02656446|Device|Accuro Handheld Ultrasound|Use of an Accuro Handheld Ultrasound to identify lumbar interspaces, midline, and depth to epidural space
16031384|NCT02656446|Device|Standard Ultrasound Machine|Use of standard ultrasound as gold standard to identify lumbar interspaces, midline, and depth to epidural space
16031385|NCT02656433|Device|Transcranial Random Noise Stimulation|A special Helmet supply weak electrical currents in the head
16031386|NCT02656433|Other|Physiotherapy|Standard of care physiotherapy aimed to the motor impairment the subject presents
16031387|NCT02656420|Drug|Broccoli Sprout-derived Beverage|Maximum, half and one-fifth doses of broccoli sprout-derived beverage compared to placebos.
16031388|NCT02656420|Drug|Placebos|Placebo as comparison to broccoli sprout-derived beverages
16031389|NCT02656407|Device|Ultrasound device|Ultrasensitive Doppler acquisition obtained with the Aixplorer ultrasound device
16031390|NCT02656394|Drug|GL101|Topical Gel
16031391|NCT02656394|Drug|Placebo|Placebo topical gel
16031392|NCT02656368|Device|SEBORRHEAMEDIS Face Cream|SEBORRHEAMEDIS Face Cream is a barrier-based, non-steroidal cream. The cream includes plant extracts The cream was designed to manage the symptoms of facial Seborrheic dermatitis symptoms such as erythema, scaling and pruritus.
16031393|NCT02656355|Other|Weight shift training and APA feedback|Use COP trajectory to train weight shift on force plate. To give APA visual feedback for subjects after weight shift training.
16031394|NCT02656355|Other|Weight shift training without APA feedback|Use COP trajectory to train weight shift on force plate.
16031395|NCT02656342|Drug|D-Cycloserine|Predicted to enhance stabilization of the effects of concentrated exposure treatment
16031396|NCT02656342|Drug|Placebo|Predicted to have no enhancing effect
16031397|NCT02656329|Drug|Iobenguane I -123 Injection|Iobenguane I-123 Injection, AdreView. All participants scheduled for an Iobenguane I-123 Injection, AdreView scan.
16031398|NCT02656329|Device|Implantable Cardioverter Defibrillator|In the Iobenguane I-123 Injection group, participants with H/M ratio less or equal to 1.6 underwent ICD device implantation, while those with H/M ratio greater than or equal to 1.6 did not undergo ICD implantation.
16031399|NCT02656329|Drug|Thyroid blocking|Participants received a thyroid blocking agent before the Iobenguane I-123 Injection, AdreView, scan unless medically not indicated, according to local practice.
16031400|NCT02656329|Drug|Iobenguane I -123 Injection|Iobenguane I-123 Injection, AdreView. All participants scheduled for an Iobenguane I-123 Injection, AdreView scan.
16031401|NCT02656329|Device|Implantable Cardioverter Defibrillator|All participants allocated to the SoC (control) group underwent ICD implantation.
16031402|NCT02656316|Device|Active tDCS|In this group subjects will receive 20 min of treatment.
16031403|NCT02656316|Device|Sham tDCS|In this group subjects will receive 20 min of sham stimulation.
16031404|NCT02656303|Biological|ublituximab|ublituximab IV infusion
16031405|NCT02656303|Drug|TGR-1202|TGR-1202 oral daily dose
16031406|NCT02656290|Device|Edwards Pericardial Aortic Bioprosthesis Model 11000A|Edwards Aortic Bioprosthesis Model 11000A in the pulmonary position; a trileaflet bioprosthesis comprised of bovine pericardium
16031407|NCT02656277|Other|Decision Tool|
16031408|NCT02656277|Other|Information on Shoulder Dislocation|
16031409|NCT02656251|Drug|0.12% Clorhexidine with alcohol|Use of 0.12% Clorhexidine with alcohol every 12 hours for 04 days
16031410|NCT02656251|Drug|placebo|Use of placebo every 12 hours for 04 days
16031411|NCT02656251|Drug|0.12% Clorhexidine without alcohol|Use of 0.12% Clorhexidine without alcohol, every 12 hours for 04 days
16031412|NCT02656225|Drug|Ejiao compound|20ml,twice daily, orally after breakfast Duration:4 weeks
16031413|NCT02656225|Drug|Niferex|one tablet,once daily, orally after breakfast Duration:4 weeks
16031414|NCT02656212|Drug|epicatechin|30 mg (+)-epicatechin, taken orally, one pill/day in the morning
16031415|NCT02656212|Drug|Placebo|Placebo pill, taken orally, one pill/day in the morning
16031416|NCT02656199|Procedure|Diaphragm Ultrasound|Once on a pressure support weaning trial, enrolled subjects will have an ultrasound of their right hemidiaphragm performed on three levels of pressure support: 15/5 10/5 and 5/5
16031417|NCT02656186|Dietary Supplement|Pre-intervention|First 2-weeks : keeping routine dietary habit
16031418|NCT02656186|Dietary Supplement|Liquid nutritional supplement|Pre-intervention period was followed by an intervention period, during which consumed twice-daily 200 mL cartons of oral liquid nutritional supplementation (total 400 mL daily, containing 16 g protein, 12 g fat and 60 g carbohydrate and providing 400 kcal)
16031419|NCT02656173|Drug|Mirabegron|Oral tablet
16031420|NCT02656173|Drug|Placebo|Oral tablet
16031421|NCT02656173|Drug|Tamsulosin|Oral tablet
16031422|NCT02656160|Drug|Placebo|Placebo 3 hrs before sleep
16031423|NCT02656160|Drug|Dalfampridine|Dalfampridine 10 mg extended release 3 hrs before sleep
16031424|NCT02656147|Biological|Anti-CD19-CAR γδT|Cells extracted, followed by induction chemotherapy before Anti-CD19-CAR γδT infusion (dose escalation.)
16031425|NCT02656134|Procedure|Duodenoscopy and enteroscopy|All patients will undergo duodenoscopy and classified according to Spigelman. Patients classified as Spigelman III and IV will undergo enteroscopy.
16031426|NCT02656134|Genetic|Molecular analysis.|DNA analysis
16031427|NCT02656121|Drug|Vitamin D|6000 IU of vitamin D3
16031428|NCT02656121|Drug|Ovulatory Agent|only Clomophine Citrate
16031429|NCT02656108|Procedure|Ommited controlled cord traction|No controlled cord traction and no fundal pressure. placenta will be allowed to deliver physiologically
16031430|NCT02656108|Procedure|controlled cord traction|active management of third stage of labor in the form of uterine massage with controlled cord traction
16031431|NCT02656095|Drug|Heparin|Participants will be given IV heparin in order to release lipoprotein lipase from capillary endothelial cells. Blood will be drawn 10-15 minutes post-heparin administration and run through assay to determine lipoprotein lipase levels.
16031432|NCT02656082|Drug|Etanercept|Treatment with etanercept is intended for remission induction of DLE only and not for maintenance purpose.
16031433|NCT02656069|Drug|G-Pen (glucagon injection)|1 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector
16031434|NCT02656069|Drug|Lilly Glucagon (glucagon injection [rDNA origin])|1 mg of Lilly glucagon reconstituted from lyophilized powder
16031435|NCT02656056|Other|Food: (Q-Can Plus fermented soybean beverage)|Fermented soybean beverage. Dose is 8 oz, twice daily.
16031436|NCT02656043|Drug|XPF-005|Comparison of active treatment XPF-005 topical gel against Placebo (XPF-005 Vehicle Gel) applied to face for acne vulgaris.
16031437|NCT02656043|Drug|Placebo|
16031438|NCT02656030|Other|semispinalis cervicis resisted exercise|semispinalis cervicis resisted exercise, 2 time per week, 6 weeks duration
16031439|NCT02656030|Other|cranio-cervical flexion exercise|cranio-cervical flexion exercise, 2 time per week, 6 weeks duration
16031440|NCT02656030|Other|usual care|usual care, 2 time per week, 6 weeks duration
16031441|NCT02656017|Drug|Metformin|Monitoring of tolerability and symptoms.
16031442|NCT02656017|Other|Placebo|Monitoring of tolerability and symptoms.
16031443|NCT02656004|Other|Essential Eucalyptus Oil|Using a disposable face mask was inhale for ten minutes 0.25 ml of essential oil of eucalyptus measured through adjustable Pipettor 100/1000μl. Inhalation of the substance occurred immediately after the 20 minute rest period in the session Essential Oil of Eucalyptus.
16031444|NCT02656004|Other|Control Session|In the control session the procedure was the same. Using a disposable face mask was inhale for ten minutes fresh air. Inhalation of the fresh air occurred immediately after the 20 minute rest period in the session Control.
16031445|NCT02655991|Behavioral|Telephone Case Monitoring|Outpatient mental health treatment as usual (normal case management, psychotherapy and/or pharmacotherapy) augmented by up to six fortnightly telephone monitoring and support calls from a case manager during the first three months of treatment.
16031446|NCT02655991|Behavioral|Treatment as Usual|Outpatient mental health treatment as usual (normal case management, psychotherapy and/or pharmacotherapy).
16031447|NCT02655978|Other|Magnetic Resonance Imaging|
16031448|NCT02655965|Drug|Ropivacaine|Ropivacaine 3.5 mg/ml
16031449|NCT02655965|Drug|Clonidine|Clonidine 5µg/ml
16031450|NCT02655965|Drug|Sodium Chloride|Sodium Chloride 0.9 %
16031451|NCT02655952|Drug|Foxy-5|
16031452|NCT02655939|Dietary Supplement|Reflex Plus|Collagen Hydrolysate: 5g ,Rosehip aqueous extract 0.55g,
16031453|NCT02655939|Dietary Supplement|Placebo|Fructose,Orange flavor and sucralose
16031499|NCT02655614|Drug|GDC-0134|GDC-0134 capsule will be administered orally at various doses, depending on the cohort and treatment period.
16031500|NCT02655614|Drug|Placebo|Placebo matching to GDC-0134
16031501|NCT02655614|Drug|Rabeprazole|Rabeprazole 20 mg twice daily orally
16031502|NCT02655614|Drug|Midazolam|2mg of liquid formulation of midazolam orally
16031503|NCT02655614|Drug|Caffeine|100 mg tablet or solution of caffeine orally
16148587|NCT01792544|Other|No Statement|
16031454|NCT02655926|Procedure|Deep Brain Stimulation|Participants undergo implantation of bilateral electrodes at both the VS/VC and STN sites through a single burr hole under general anaesthesia. High-resolution MRI scans are used to calculate target coordinates and to verify accurate electrode location post-surgery. Each STN electrode have 4 electrical contacts at its distal tip (with a 0.5mm separation) and each VS/VC electrode have 4 electrical contacts at its distal tip (with a 1.5mm separation) to allow fine tuning of the exact site for stimulation delivery. Two non-rechargeable batteries (Activa PC) are connected to the electrodes and positioned under the skin of the right and left chest wall so that they correspond to the same set of electrodes for each patient: one for the 2 STN electrodes and one for the 2 VC/VS electrodes.
16031455|NCT02655913|Drug|vitamin C|Vitamin C infusion, as an alternative anticancer therapy, has been used for many years. In the last 10 years, an increasing number of studies have indicated that VitC in pharmacological concentration can selectively kill cancer cells. Phase I clinical trial showed that VitC(1.5g/kg, 90-120mins, 3 times a week) infusion is safe without significant adverse reactions. A phase II clinical trial indicated that large dose of vitC infusion can reduce toxic side effects from chemo drugs when it was used synergy with chemotherapy.
16031456|NCT02655913|Device|Modulated Electro-Hyperthermia (mEHT)|MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.
16031457|NCT02655913|Other|Supportive care|Supportive care focuses on helping patients get relief from symptoms such as nausea, pain, fatigue, or shortness of breath,etc.
16031458|NCT02655900|Other|Pelvic Floor Ultrasound|Transperineal Ultrasound (3D TPUS) and Endovaginal Ultrasound (3D EVUS)
16031459|NCT02655887|Device|VENOVO™ Venous Stent|VENOVO™ Venous stent placement
16031460|NCT02655874|Biological|Influenza vaccine|Administered at day 1
16031461|NCT02655874|Biological|Influenza vaccine|Administered at day 180
16031462|NCT02655874|Biological|Tetanus-diphtheria-pertussis vaccine|Administered at day 180
16031463|NCT02655861|Other|Observation|
16031464|NCT02655848|Procedure|Arthroscopic rotator cuff repair|Arthroscopic rotator cuff repair using suture anchors
16031465|NCT02655848|Procedure|LHB Tenodesis|Arthroscopic tenotomy and subsequent fixation of long head biceps proximal in the biceps groove
16031466|NCT02655848|Procedure|LHB Tenotomy|Arthroscopic tenotomy of long head biceps
16031467|NCT02655835|Behavioral|Internet Mindfulness Meditation|
16031468|NCT02655835|Behavioral|Access|
16031469|NCT02655822|Drug|Ciforadenant|100 mg orally twice daily for the first 14 days of each 28-day cycle.
16031470|NCT02655822|Drug|Ciforadenant|100 mg orally twice daily for 28 days of each 28-day cycle.
16031471|NCT02655822|Drug|Ciforadenant|200 mg orally once daily for the first 14 days of each 28-day cycle.
16031472|NCT02655822|Drug|Ciforadenant + atezolizumab|Ciforadenant 100 mg orally twice daily in combination with atezolizumab intravenously.
16031473|NCT02655822|Drug|Ciforadenant|Start with 150mg orally twice daily for 28-day cycles; then, increase increments by 100mg/day for 6 dose levels.
16031474|NCT02655809|Radiation|Fluoroscopic examination|
16031475|NCT02655796|Device|OAK|The OAK device evaluates the fall risk through exercises assessing mobility, equilibrium and postural reaction.
16031476|NCT02655783|Other|5% dextrose|women with an elective induction of labor receive IV hydratation (250 ml/h) with a normal saline solution + 5% dextrose
16031477|NCT02655783|Other|normal saline|women with an elective induction of labor receive IV hydratation (250 ml/h) with a normal saline solution
16031478|NCT02655770|Drug|Liraglutide|
16031479|NCT02655770|Drug|Placebo|
16031480|NCT02655757|Drug|Sitagliptin|5 mg, 1 tablet per day for 12 months
16031481|NCT02655757|Drug|Placebo|Placebo,1 tablet per day for 12 months
16031482|NCT02655744|Radiation|Standard treatment protocol with combined chemoradiation|
16031483|NCT02655731|Device|PVI with HeartLight|Catheter ablation
16031484|NCT02655718|Other|Patients with ACS|Cardiovascular magnetic resonance (CMR) imaging with contrast (Gadovist) in regime inversion recovery time, regime T-2 weighted images , T1-weighted images.
16031485|NCT02655718|Device|MRI|
16031486|NCT02655705|Drug|Cyclosporine A|Male 200 mg/day, Female 150 mg/day for 16 weeks
16031487|NCT02655705|Drug|Methotrexate|Initial dose with 10 mg/week, increasing 2.5 mg every 2 weeks up to 15 mg/week maintenance dose
16031488|NCT02655692|Drug|Ketamine|FDA approved anesthetic medication with rapid acting antidepressant effects.
16031489|NCT02655692|Drug|Placebo|This is a saline placebo/non-active solution.
16031490|NCT02655679|Drug|VTP-38543|VTP-38543 topical cream
16031491|NCT02655679|Other|Vehicle with Transcutol®P|Vehicle matching VTP-38543 cream with Transcutol®P
16031492|NCT02655679|Other|Vehicle without Transcutol®P|Vehicle matching VTP-38543 cream without Transcutol®P
16031493|NCT02655653|Drug|Epsilon-aminocaproic acid administered|Following anesthetic induction, Epsilon-aminocaproic acid was administered as a bolus loading dose of 150 mg/ kg followed by a maintenance infusion of 15 mg/ kg /hr. Maintenance infusion of both drugs was discontinued when the patient arrived in the cardiac surgical intensive care unit. In addition to routine blood sampling ( standard of care in our hospital), patients had thromboelastogram(TEG) and D-dimer levels drawn at the following time points: post incision but prior to initial antifibrinolytic load, immediately following the antifibrinolytic loading dose, and post-protamine reversal of heparin.
16031494|NCT02655653|Drug|Tranexamic Acid administered|Following anesthetic induction, Tranexamic Acid was administered as a bolus dose of 30 mg /kg followed by a 16 mg/ kg/hour maintenance infusion. Maintenance infusion of both drugs was discontinued when the patient arrived in the cardiac surgical intensive care unit. In addition to routine blood sampling ( standard of care in our hospital), patients had thromboelastogram(TEG) and D-dimer levels drawn at the following time points: post incision but prior to initial antifibrinolytic load, immediately following the antifibrinolytic loading dose, and post-protamine reversal of heparin.
16031495|NCT02655640|Other|Questionnaires|Questionnaires will be provided to patients
16031496|NCT02655627|Other|Internet based exercise training|
16031497|NCT02655627|Other|group exercise training|
16031504|NCT02655601|Drug|BMX-001|BMX-001 consists of a porphyrin ring with pyridyl groups attached at each of the four methane bridge carbons. The nitrogen in the pyridyl ring is at the 2 position and has a side chain consisting of six carbons with an ether linkage. A manganese atom is chelated into the porphyrin ring and is the active center of the molecule. This molecule is an enzymatic scavenger of free radical species operating at close to diffusion-limited rates.
16031505|NCT02655601|Radiation|Radiation Therapy|RT will be delivered in daily fractions of 1.8-2 Gy given 5 days a week for 6 weeks for a total of 59.4-60 Gy.
16031506|NCT02655601|Drug|Temozolomide|Initially, temozolomide (TMZ) will be dosed at 75 mg/m2 orally daily for 42 days. Two weeks after the completion of chemoradiation, patients will transition to adjuvant chemotherapy with TMZ dosed at 150-200 mg/m2 orally for 5 days of a 28-day cycle for a total of 12 cycles.
16031507|NCT02655588|Behavioral|Interactive Media-Based Problems Solving Treatment|
16031508|NCT02655575|Behavioral|BI + VR + CBT|Brief intervention (information and advice) + group-based vestibular rehabilitation combined with cognitive behavioral therapy
16031509|NCT02655575|Behavioral|BI + phone calls|Brief intervention (information and advice). Patients are followed-up by phone calls
16031510|NCT02655562|Drug|Montelukast|"Patients in biomarker treatment arm and FENO≥25ppb were given Montelukast Sodium Tablets (p.o., 10mg, qd) . Patients in biomarker reatment arm and FENO<25ppb were given placebo (p.o., 10mg, qd).
~Patients in standard treatment arm and FENO≥25ppb were given placebo (p.o., 10mg, qd). Patients in standard treatment arm and FENO<25ppb were given Montelukast Sodium Tablets (p.o., 10mg, q.d.).All treatment regimens lasted for 10 days and no other antitussive/decongestant or bronchodilators are given to any patients."
16031511|NCT02655549|Biological|Px563L, RPA563, or placebo|Two intramuscular injections
16031512|NCT02655536|Drug|Bevacizumab plus erlotinib|Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of every 3 weeks cycle by IV infusion erlotinib will be give at 150mg orally every day for 21 days of every 3 weeks cycle
16031513|NCT02655536|Drug|Erlotinib|erlotinib will be give at 150mg orally every day for 21 days of every 3 weeks cycle
16031514|NCT02655523|Drug|Triamcinolone|1 mL of 40 mg of Triamcinolone
16031515|NCT02655523|Drug|Dexamethasone|1 mL of 4mg of Dexamethasone
16031516|NCT02655523|Drug|Normal Saline|1 mL of preservative free normal saline
16031517|NCT02655523|Drug|Bupivacaine|2 mL of 0.5% bupivacaine
16031518|NCT02655510|Drug|F-652|Participants will receive 10 μg/kg, 30 μg/kg or 45 μg/kg of F-652 on Day 1 and Day 7 via slow intravenous infusion. Three patients will receive 10 μg/kg of F-652. Pharmacokinetic testing will be completed on these subjects. If evaluations demonstrate safety and efficacy signals, the next 3 patients will receive 30 μg/kg. If pharmacokinetic testing demonstrates safety and efficacy signals, the next 3 patients will receive 45 μg/kg.
16031519|NCT02655497|Behavioral|Cognitive training|
16031520|NCT02655497|Behavioral|Psychosocial education|
16031521|NCT02655484|Device|"BiPAP® Vision® ventilator（Ventilator, Philips Respironics™ BiPAP® Vision® ）"|See details from arm descriptions.
16031522|NCT02655471|Drug|"Raltegravir and Zidovudine"|Through measure of pro-viral load and clinical score, we evaluate about safety and efficacy of combination of Raltegravir 400 mg BID and zidovudine 300 mg BID in patients with recent onset of Tropical Spastic paraparesis due HTLV-1 during 48 weeks
16031523|NCT02655458|Drug|Elotuzumab|"The following must also be administered before any elotuzumab:
~Dexamethasone 8 mg IV (on the day of elotuzumab infusion 45-90 mins prior to the start of infusion), the following 30 - 90 minutes prior to start of infusion: H1 blocker: diphenhydramine (25 - 50 mg po or IV) or equivalent, H2 blocker: ranitidine (50 mg IV) or equivalent (adjusted for renal failure as indicated), acetaminophen (650 - 1000 mg po)."
16031524|NCT02655458|Drug|Lenalidomide|On the days of elotuzumab administration, the dose of lenalidomide is to be administered at least 2 hours after completion of elotuzumab dosing. Aspirin 81 mg PO daily will also be prescribed for DVT prophylaxis.
16031525|NCT02655458|Other|autologous PBMC reconstitution|Autologous peripheral blood mononuclear cell collection and reconstitution. PBMC will be collected from patients by standard apheresis procedures. Up to 25 ml of autologous plasma will also be recovered for dilution of cryopreserved products (if necessary). For reconstitution, Patients will be pre-medicated as per each institution's standard protocols prior to reinfusion of PBMC products. Patient ID will be checked and verified by nursing staff and the products will be re-infused by continuous intravenous infusion pump. Patient vital signs will be monitored every 15 minutes for the duration of the procedure as per standard reinfusion protocol.
16031526|NCT02655458|Other|ASCT|"Autologous peripheral blood stem cell transplantation. (stem cells from the patient's own marrow are harvested, stored and then returned to the body (engrafted). To be done as part of standard of care."
16031527|NCT02655445|Procedure|Mini-craniotomy|chronic subdural hematoma evacuation through minicraniotomy
16031528|NCT02655445|Procedure|Twist Drill Craniostomy|chronic subdural hematoma evacuation through twist drill craniostomy
16031529|NCT02655445|Procedure|Burr Hole Craniostomy|chronic subdural hematoma evacuation through burr holes
16031530|NCT02655432|Device|Spot photoscreener|Screening of vision problem through an automated device
16031531|NCT02655432|Procedure|Ophthalmologic evaluation|Screening of vision problem through an ophthalmologic evaluation
16031532|NCT02655432|Procedure|Cyclopleged refraction|Screening of refractive problems through a cyclopleged optometric refraction
16031533|NCT02655419|Drug|ATM-AVI|"Cohort 1:
~(Creatinine clearance > 50 mL/min)6500mg ATM/1777mg AVI on day 1 followed by total daily dose of 6000mg ATM/1640mg AVI
~Cohorts 2 and 3:
~(Creatinine clearance > 50 mL/min) As above, or: 6500 mg ATM/2167 mg on Day 1 followed by a total daily dose of 6000 mg ATM/2000 m AVI
~(Creatinine clearance 31 - 50 mL/min) 4250 mg ATM/1162 mg AVI on Day 1 followed by total daily dose 3000 mg ATM/820 mg AVI, or:
~4250 mg ATM/1417 mg AVI on Day 1 followed by total daily dose 3000 mg ATM/1000 mg AVI"
16031534|NCT02655419|Drug|Metronidazole|Metronidazole 500mg infused over 1 hour every 8 hours
16031535|NCT02655406|Other|Class 2 compression stockings|
16031537|NCT02655380|Drug|Ketamine 1|Anesthesia induction is performed with 1 mg ketamine.
16031538|NCT02655380|Drug|Ketamine 2|Anesthesia induction is performed with 2 mg ketamine.
16031539|NCT02655380|Drug|Remifentanil|After anesthesia induction with ketamine, predetermined remifentanil using Dixon's up and dowm method is administered.
16149600|NCT01784302|Drug|Maalox Plus extra|
16031540|NCT02655367|Other|Flaked oats|Test meal consisting of 264g porridge made with flaked oats
16031541|NCT02655367|Other|Milled oats|Test meal consisting of 264g porridge made with milled oats
16031542|NCT02655354|Behavioral|Motivational Interviewing|
16031543|NCT02655354|Behavioral|Cognitive Behavioral Therapy Elements|
16031544|NCT02655354|Behavioral|Care Management|
16031545|NCT02655354|Drug|Fluoxetine|Anti-depressant
16031546|NCT02655354|Drug|Fluvoxamine|Anti-depressant
16031547|NCT02655354|Drug|Paroxetine|Anti-depressant
16031548|NCT02655354|Drug|Sertraline|Anti-depressant
16031549|NCT02655354|Drug|Citalopram|Anti-depressant
16031550|NCT02655354|Drug|Venlafaxine|Anti-depressant
16031551|NCT02655354|Drug|Duloxetine|Anti-depressant
16031552|NCT02655354|Drug|Mirtazapine|Anti-depressant
16031553|NCT02655354|Drug|Diphenhydramine|Sleep medication
16031554|NCT02655354|Drug|Trazodone|Sleep medication
16031555|NCT02655354|Drug|Prazosin|Sleep medication
16031556|NCT02655341|Device|Body Composition Monitoring|using Fresenius device; two measurements before and after coronary intervention;
16031557|NCT02655341|Procedure|Coronarography|Preprocedural coronary arteriography is obtained after sterile preparation and draping of the patient, conscious sedation, infiltration of local anesthetic (lidocaine solution) at the femoral access site, placement of an arterial sheath in the femoral artery, and advancement of the renal guide catheter over a 0.035-in guidewire under fluoroscopic guidance. After the tip of the guide catheter is positioned at the ostium of the left coronary stem, an angiogram is obtained. After the guidewire is removed, the proximal end of the catheter is connected to a manifold, and 4-8 mL of contrast is manually injected during cineangiographic recording.
16031558|NCT02655341|Procedure|Primary Percutaneous Coronary Intervention|An intravenous antithrombotic agent, usually heparin, is administered before the clinician proceeds with angioplasty.
16031559|NCT02655341|Procedure|Renal Angiography|After the tip of the guide catheter is positioned at the ostium of the renal artery, an angiogram is obtained. After the guidewire is removed, the proximal end of the catheter is connected to a manifold, and 4-8 mL of contrast is manually injected during cineangiographic recording. This procedure is performed in the same time with primary PCI
16031560|NCT02655328|Other|blood sample|blood sample
16031561|NCT02655328|Other|urine sample|urine sample
16031562|NCT02655315|Drug|Deferiprone|15 mg / kg twice daily morning and evening (30mg / kg per day).The treatment lasts nine months.
16031563|NCT02655315|Drug|Placebo|the placebo twice daily morning and evening. The treatment lasts nine months
16031564|NCT02655302|Other|Sample collecting|Collect sputum, blood and nasopharyngeal swab during the exacerbation and at steady state 8 to 16 weeks later.
16031565|NCT02655302|Other|Lung function measure|Measure lung function and follow it during 4 years
16031566|NCT02655289|Device|Modulated TENS|"Frequency: 100 Hz
~Intensity: individual; TENS should be clearly perceptible but not painful; impulse width is coupled with intensity
~Mode: intensity modulation (40% decrease every 0.5 seconds)
~TENS device: ARTROSTIM® SELECT
~Channels: 2
~Electrodes: 4 (5x5cm), placed on site of pain (a little more proximal if allodynia is present)"
16031567|NCT02655289|Device|Placebo TENS|"Frequency: 100 Hz (conventional for High TENS; Placebo is achieved by reduction of intensity, see below)
~Intensity: The device is on and will be up-regulated together until the first sensation is perceptible. Then the activated device will be down-regulated minimally (no sensation perceptible) and this configuration will be retained.
~Mode: continuous
~TENS device: ARTROSTIM® SELECT
~Channels: 2
~Electrodes: 4 (5x5cm), placed on site of pain (a little proximal if allodynia is present)"
16031568|NCT02655276|Other|microencapsulated Glycine|100 mg microencapsulated Glycine (Bidicin® from Biotiki® ) t.i.d.
16031569|NCT02655276|Other|Placebo tablets|Placebo t.i.d. from Biotiki® in a crossover-design.
16031570|NCT02655263|Drug|Somatropin|Somatropin infusion (Genotropin®)
16031571|NCT02655263|Other|Ketone bodies|ketone bodies infusion
16031572|NCT02655250|Other|Microbiome|
16031573|NCT02655237|Drug|Relugolix|Relugolix tablets
16031574|NCT02655237|Drug|Relugolix Placebo|Relugolix placebo-matching tablets
16031575|NCT02655237|Drug|Leuprorelin|Leuprorelin injection
16031576|NCT02655237|Drug|Leuprorelin Placebo|Leuprorelin placebo-matching injections
16031577|NCT02655224|Drug|Relugolix|Relugolix Tablets
16031578|NCT02655224|Drug|Relugolix placebo|Relugolix placebo-matching tablets
16031579|NCT02655211|Procedure|CO2 laser treatment|Surgical treatment using fractionated ablative carbon dioxide laser (CO2)
16031580|NCT02655211|Procedure|PDL laser treatment|Surgical treatment using flashlamp-excited pulsed dye laser (PDL)
16031581|NCT02655211|Other|Usual care|Usual care (i.e., non-surgical) therapy (compression garments, massage, physical therapy, silicone gel sheeting)
16031582|NCT02655198|Drug|Fenfluramine|study of efficacy and safety of add-on fenfluramine at different dosages in refractory Lennox Gastaut patients : 0.2 - 0.4 and 0.8 mg/kg/day (max 30 mg).
16031583|NCT02655172|Other|cognitive tasks + PANSS+ IQ|Patients will perform different tasks: reaction time (Alert TEA, Zimmermann and Fimm, 2005), Edinburgh laterality questionnaire (Oldfield,1971), IQ test (IQ: PM38, Raven, 1960), and the PANSS (Positive and Negative Syndrome Scale (Kay et al., 1987) + the experimental task (affordance task with graspable device)
16031584|NCT02655172|Other|cognitive tasks|Healthy volunteers will perform only Edinburgh laterality questionnaire (Oldfield, 1971) + the experimental task (affordance task with graspable device).
16031585|NCT02655146|Drug|triptorelin 0.1|a single dose of decapeptyl 0.1 s.c. on the 3rd day of embryo transfer with routine luteal phase support.
16031586|NCT02655146|Drug|E2|Patients will be on the Progynova tablets 4-10mg daily at least 14 days.
16031587|NCT02655146|Drug|Progesterone|After ultrasound and hormorne tests, progesterone 100mg intramuscular injection is allocated with Progynova.
16031588|NCT02655146|Drug|triptorelin 3.75mg|as a pretreatment of E2 in some subjects with a fail history of hormonal artificially endometrium preparing.
16031589|NCT02655133|Drug|Pentaglobin®|Immunoglobulins that will be used are IgM enriched and will be infused at 5 ml/Kg/day for 3 days.
16031590|NCT02655133|Drug|Physiologic solution|Physiologic solution will be infused and will be infused at 5 ml/Kg/day for 3 days.
16031591|NCT02655120|Procedure|Drilling|
16031593|NCT02655081|Dietary Supplement|high arginine nutritional supplement (Nestle's Impact AR)|Preoperative High-Arginine Nutritional Supplement Prior to Radical Cystectomy
16031594|NCT02655068|Other|PET/CT|"Patients who undergo primary radiotherapy will have their first study imaging surveillance at 6 months (+/- 30 days) post radiotherapy. The Positron Emission Tomography - Computed Tomography (PET/CT)surveillance will continue at 9,12,18,24 months.
~During years 3-5, or long term follow up, surveillance with history and physical examination will occur every 6 months (+/- 30 days).
~The last protocol-specified imaging will occur at 24 months; during long term follow-up imaging will be conducted per the judgment of the treating physicians, as indicated by the history and physical examination findings."
16031595|NCT02655068|Other|Computed Tomography (CT)|"Patients who undergo primary surgery will have their first study imaging surveillance at 3 months (+/- 30 days) post-surgery. CT surveillance will continue at 6,9,12,18,24 months.
~During years 3-5, or long term follow up, surveillance with history and physical examination will occur every 6 months (+/- 30 days).
~The last protocol-specified imaging will occur at 24 months; during long term follow-up imaging will be conducted per the judgment of the treating physicians, as indicated by the history and physical examination findings"
16031596|NCT02655055|Procedure|high frequency voluntary apheresis blood donation|
16031597|NCT02655029|Drug|Perindopril/Indapamide/Amlodipine fixed dose combination|Dose selection is based on investigators management.
16031600|NCT02655003|Other|TIME|
16031601|NCT02655003|Other|Education-only intervention|The staff and physicians in the control nursing homes will receive a 2 hours education session about dementia and neuropsychiatric symptoms
16031602|NCT02654990|Drug|panobinostat capsules|20mg, 10mg or 15mg (for dose reductions only)
16031603|NCT02654990|Drug|bortezomib injection|1.3mg/m2 sub-cutaneous administration; Cycle 1-4: 2 weeks on/1 week off twice a week for patients <=75 years at time of screening; once a week for patient > 75 years Cycle 5+: once a week for all patients
16031604|NCT02654990|Drug|dexamethasone tablets|pre and 24h after BTZ administration; patients <= 75 years at time of screening: 20mg/dose patients > 75 years: 10mg/dose
16031605|NCT02654977|Drug|Metreleptin|MyaLept (Recombinant-methionyl Human Leptin (r-metHuLeptin) METRELEPTIN) subcutaneous injections
16031606|NCT02654964|Drug|Combination Drug Therapy|"Up to 3 of 73 possible interventions from the drug classes listed below will be selected based on their potency against CSCs, potential for synergy without cross-reactive toxicities, drug safety profiles, pharmacokinetics, and drug-drug interactions. Those patients that have GBM that has recurred (as defined by RANO (45)), and for whom HTS was successfully completed, will be eligible to continue to the treatment component of the study to receive the drug cocktail comprised from the following drug classes:
~Antineoplastic Anti-infective Antiemetic Antihyperlipidemic Anti-inflammatory Antihistamine Antihypertensive Antidepressant Cardiotonic Alcohol antagonist Diuretic Antipsychotic NMDA receptor antagonist Antidiabetic Immunosuppressant Anticonvulsant Antimethemoglobinemic Sclerosing agent"
16031607|NCT02654951|Other|Visual Feedback|"The visual feedback condition will use a monitor to display two cursors (empty circles) that will represent the participant's hands, and the circles will fill with red ink as the user starts to compensate outside a normal error band. The amount of red ink will increase proportionally to the magnitude of trunk compensation.
~The goal of the participants will be to move their hands/cursors towards a target, while keeping the cursors as empty as possible."
16031608|NCT02654951|Other|Force Feedback|"A monitor will display the same cursors as in the visual feedback condition, however, the cursors will be completely empty and will not fill with color.
~The force feedback cues will be provided as resistance to move the robots' handles. These cues will be applied when the user moves outside a normal error band. In addition, the magnitude of the cue will be proportional to the magnitude of trunk compensation.
~The goal of the participants will be to move their hands/cursors towards a target, while moving the robots with the least resistance possible."
16031609|NCT02654938|Drug|Mobilan (M-VM3)|Mobilan (M-VM3), innovative experimental drug based on non-replicate adenoviral delivery system consisting genomic vector coding TLR5-receptor and its ligand 502s.
16031610|NCT02654938|Drug|Placebo|5% infusion solution of dextrose
16031611|NCT02654925|Procedure|Adipose Tissue Biopsy|
16031612|NCT02654912|Drug|Reactive Focal Drug Administration|This is the experimental arm and is described by a reactive response to passively detected index case of malaria. The reactive response consists of treating all individuals within a defined radius of each RDT-confirmed incident malaria case with dihydroartemisinin-piperaquine (DHAP).
16031613|NCT02654899|Drug|PF-06815345|PF-06815345 will be administered as a liquid dosage formulation
16031614|NCT02654899|Other|Placebo|Placebo
16031615|NCT02654899|Drug|PF-06815345|PF-06815345 will be administered as either solid dosage formulation or liquid dosage formulation
16031616|NCT02654886|Other|Resistance Exercise Training|"Resistance Exercise Training: knee extension and elbow flexion each 3 times per week 3 sets each session; 10 reps/set for 6 months
~Respiratory muscle strength training: 25 repetitions -twice daily, 6 days/week for 6 months"
16031620|NCT02654847|Drug|Norepinephrine|
16031621|NCT02654847|Drug|Normal Saline|0.9% sodium chloride solution, used as a diluent.
16031622|NCT02654834|Other|Exposure to nitrous oxide or other volatile anesthetics|No intervention, but routine work-place exposure to volatile anesthetics
16031623|NCT02654821|Biological|TCR transduced T-cells|Eligible patients will undergo leukapheresis to isolate autologous T cells. These T cells will be transduced with a retroviral vector encoding the 1D3 HM CysTCR, and subsequently expanded during short-term ex vivo culture. Following pre-treatment with nonmyeloablative chemotherapy, patients will receive the adoptive transfer of autologous, TCR transduced T cells.
16033587|NCT02641002|Drug|CC-90002|Monoclonal Ab to CD47
16031624|NCT02654821|Procedure|Biopsy|During screening, after treatment and at time of regression/progression a biopsy will be taken for translational research.
16031625|NCT02654821|Procedure|Blood taking|During screening, after the infusion with T-cells, after treatment and at time of regression/progression blood will be taken for translational research.
16031626|NCT02654808|Device|AirSeal trocar|"The AirSeal® trocar is a valveless trocar that has been designed to replace the trap door and silicone valve of standard trocars with a curtain of forced CO2 gas. With the AirSeal® trocar, escaping gas is collected at the proximal end of the trocar, filtered, and redirected into the peritoneal cavity to maintain the pressure differential. The result is an invisible barrier that instantaneously responds to changes in intra-abdominal pressure, either by allowing more CO2 inflow with pressure drops or by serving as a pressure relief valve during pressure spikes."
16031627|NCT02654808|Device|Standard trocar|"A standard insufflation trocar delivers CO2 into the abdominal cavity to create workspace and uses either a trap door or silicone valve to prevent the egress of CO2 during laparoscopy in order to maintain intra-abdominal pressures. The standard trocars are not equipped to respond to changes in the intra-abdominal pressures in order to trigger an increase or decrease in the flow rate of CO2 gas."
16031628|NCT02654795|Radiation|computed tomography|CT angiography will be performed with a dual-source CT scanner using prospective ECG gating, with detector collimation of 128x0.6 mm, a gantry rotation time of 280 ms, tube voltage of 100-120 kV, tube current of 280-380 mAs depending on the patient's body mass.
16031629|NCT02654782|Drug|Lactated Ringer's|Crystalloid fluid given for hemodynamic resuscitation based off of individual patient needs.
16031630|NCT02654782|Drug|5% Human Albumin|Colloid given for hemodynamic resuscitation based off of individual patient needs.
16031631|NCT02654769|Drug|Ingenol Mebutate (Picato®)|Brand product
16031632|NCT02654769|Drug|Generic Ingenol Mebutate|Generic formulated to have the same therapeutic effect of the brand
16031633|NCT02654769|Drug|Vehicle Foam|It does not contain active ingredient. A placebo to test the sensitivity of the active treatments.
16031634|NCT02654743|Dietary Supplement|Sulforaphane|Children with ASD will receive Sulforaphane in this study
16031635|NCT02654730|Drug|Dihydroartemisinin-piperaquine (DHAP) administered to G6PD deficient|G6PD deficient participants will be treated with dihydroartemisinin-piperaquine (Eurartesim®; Sigma Tau) administered as 3 tablets (40mg PPQ, 320mg DHA) in a once daily regimen for three days
16031636|NCT02654730|Drug|Dihydroartemisinin-piperaquine (DHAP) + 0.25 mg/kg primaquine administered to G6PD deficient|G6PD deficient participants will be treated with dihydroartemisinin-piperaquine (Eurartesim®; Sigma Tau) administered as 3 tablets (40mg PPQ, 320mg DHA) in a once daily regimen for three days in combination with a single dose of 0.25mg/kg of primaquine on the first day of DHAP treatment.
16031637|NCT02654730|Drug|Dihydroartemisinin-piperaquine (DHAP) + 0.4 mg/kg primaquine administered to G6PD deficient|G6PD deficient participants will be treated with dihydroartemisinin-piperaquine (Eurartesim®; Sigma Tau) administered as 3 tablets (40mg PPQ, 320mg DHA) in a once daily regimen for three days in combination with a single dose of 0.4mg/kg of primaquine on the first day of DHAP treatment.
16031638|NCT02654730|Drug|Dihydroartemisinin-piperaquine (DHAP) + 0.25 mg/kg primaquine administered to G6PD normal|G6PD normal participants will be treated with dihydroartemisinin-piperaquine (Eurartesim®; Sigma Tau) administered as 3 tablets (40mg PPQ, 320mg DHA) in a once daily regimen for three days in combination with a single dose of 0.25mg/kg of primaquine on the first day of DHAP treatment.
16031639|NCT02654730|Drug|Dihydroartemisinin-piperaquine (DHAP) + 0.4 mg/kg primaquine administered to G6PD normal|G6PD normal participants will be treated with dihydroartemisinin-piperaquine (Eurartesim®; Sigma Tau) administered as 3 tablets (40mg PPQ, 320mg DHA) in a once daily regimen for three days in combination with a single dose of 0.4mg/kg of primaquine on the first day of DHAP treatment.
16031640|NCT02654717|Drug|DFD-07 Cream|
16031641|NCT02654717|Drug|Placebo Cream|
16031642|NCT02654704|Biological|Pneumococcal Vaccination|The individuals will be followed to observe their immune system activation, following their vaccination with the standard Pneumococcal Polysaccharide Vaccine (PPSV23) as approved by the FDA.
16031643|NCT02654678|Drug|Enalapril Orodispersible Minitablet|Weight-dependent long-term treatment scheme with enalapril ODMTs of 0.25 and/or 1 mg strength
16031644|NCT02654665|Behavioral|Lifestyle modification|Diet and exercise designed for 5-7% weight loss over 6 months
16031645|NCT02654665|Drug|Liraglutide|GLP-1 agonist
16031646|NCT02654652|Dietary Supplement|Symbiotic|Intervention will consist of the adminitration of symbiotic product twice a day during seven days after surgical treatment
16031647|NCT02654652|Dietary Supplement|Maltodextrin|Intervention will consist of the adminitration of placebo product twice a day during seven days after surgical treatment
16031648|NCT02654639|Drug|TAS-102|TAS-102 Twice a day by mouth day 1-5 and 8-12
16031649|NCT02654639|Drug|Bevacizumab|Bevacizumab by intravenous infusion once every 14 days
16031650|NCT02654626|Drug|KBP-7072|Drug Intervention
16031651|NCT02654626|Other|Placebo|
16031652|NCT02654613|Other|Quality Improvement Model of Care|"QI addresses the how of program implementation. Technically, QI improves process performance by developing a common simplified view of the components and linkages of integrated care, real-time data feed-back to track system performance, understanding the psychology of system change, and crucially, the iterative testing and incorporation of ideas for performance improvement from the front-line practitioners, managers, and customers in the local context."
16031653|NCT02654587|Drug|OSE2101|
16031654|NCT02654587|Drug|Docetaxel|
16031655|NCT02654587|Drug|Pemetrexed|
16031656|NCT02654574|Other|IADL administration by phone|The administration of IADL questionnaire by phone consists of a collection of answers given by the caregiver during the interview with the research nurse, trained for this procedure. This method of procurement will be standardized with a listing support for the phone interview to obtain the same conditions for collection of data from a caregiver to another. Questions will be asked in the same order than the questionnaire collected with the reference procedure i.e. face-to-face interview at the Memory Clinic. The IADL questionnaires in paper format used during the ace-to-face interview and by phone will be identical.
16031657|NCT02654561|Drug|Heparin Sodium|A bottle solution of Heparin Sodium(2ml:12500IU) is added to 50ml saline and administered i.v. continuously for 24 hours, which last 7 days or until the death or discharge. The same amount of 0.9% saline as the heparin group will be administered in the placebo group.
16031658|NCT02654561|Drug|Saline|For all the severe sepsis or septic shock patients, normal saline will be administered for fluid resuscitation according to the Guideline of Survival Sepsis Campaign.
16031659|NCT02654548|Other|Sebutape|Women who consent to the study will have a sebutape attached to their and their babies foreheads to measure the levels of androgens.
16031660|NCT02654535|Other|Dietary tree nuts & peanuts|An intervention in which tree nuts and/or peanuts are included in the diet
16031661|NCT02654522|Drug|Hylenex|1-3 hours post injection, the 8 HA injection sites (4 per forearm) per subject will then receive a randomized amount of Hylenex recombinant (0U, 30U, 60U or 75U).
16031662|NCT02654509|Biological|Eastern Equine Encephalitis Vaccine, Inactivated, Dried, TSI-GSD 104|Eastern Equine Encephalitis Vaccine, Inactivated, Dried
16031663|NCT02654496|Other|Meal challenge|Participants will receive a liquid nutritional supplement. Before and after administration, biological variables of interest will be collected.
16031664|NCT02654483|Drug|VPD-737|VPD-737 inhibits the receptor neurokinin-1.
16031665|NCT02654483|Other|Placebo|Matching tablets to VPD-737 tablets without active drug
16031666|NCT02654470|Device|Watchman FLX|Patients who are receiving the Watchman FLX device
16031667|NCT02654457|Procedure|Women with Breast Cancer|IVD Study
16031668|NCT02654431|Procedure|Breast Cancer patient|Samples
16031669|NCT02654431|Procedure|Cancer patients|Samples
16031670|NCT02654418|Procedure|Endoscopic Mucosal Resection of large colon polyps (greater than or equal to 20 mm in size)|
16031671|NCT02654405|Dietary Supplement|Sodium Butyrate|6.57 gms of sodium butyrate per day for 12 weeks
16031672|NCT02654405|Other|Placebo|placebo capsules containing approximately 9 mg of sodium butyrate/day
16031673|NCT02654392|Dietary Supplement|corn syrup|This group will receive an iso-energetic corn syrup supplement everyday for 5 weeks
16031674|NCT02654392|Dietary Supplement|Polyunsaturated fatty acid|This groups will receive 4 capsules/70kg body mass (Pureform Omega® capsules made from Fax, Sunflower, Coconut, Evening Primrose, & Pumpkin oils) every day for 5 weeks
16031675|NCT02654379|Biological|Rituximab|Rituximab use in non-oncology indications
16031676|NCT02654366|Behavioral|Risk Reduction Group|"The Risk Reduction and Treatment Readiness skills component includes six modules: 1) BNEP services and substance abuse treatment; 2) nature of chemical dependence (severity/chronicity and medical aspects); 3) infectious diseases (HIV and Hepatitis C virus (HCV) information); 4) injection drug use risk reduction (effective equipment cleaning and drug-splitting techniques); 5) sex risk reduction (reducing high-risk behaviors and effective condom use); and 6) overdose prevention.
~The Community Outreach skills component is devoted to discussing the benefits of recovery-focused social support, and directing BNEP registrants and their CSPs to participate in activities together (as determined in the group session) at least 1 time per week to work toward expanding the scope of drug-free social support."
16031677|NCT02654353|Procedure|Ablation|In both arms, patients will undergo an ablation procedure for persistent atrial fibrillation. The sequence of ablation steps are different between both arms.
16031678|NCT02654327|Device|VV-ECCO2R to enable lower tidal volume mechanical ventilation|In the intervention arm a dual lumen catheter will be inserted into a central vein. VV-ECCO2R is commenced and managed as per study manual. Tidal volumes are then reduced on mechanical ventilation to enable lower tidal volume ventilation. Lower tidal volume facilitated by VV-ECCO2R will continue for a least 2 days up to a maximum of 7 days
16031679|NCT02654314|Drug|Melatonin|
16031680|NCT02654301|Dietary Supplement|Test 1|sucrose : xylose = 10:1, sucrose 50 g + xylose 5 g + deionized water 95 g
16031681|NCT02654301|Dietary Supplement|Test 2|sucrose : xylose = 15:1, sucrose 50 g + xylose 3.33 g + deionized water 96.67 g
16031682|NCT02654301|Dietary Supplement|Test 3|sucrose : xylose = 20:1, sucrose 50 g + xylose 2.5 g + deionized water 97.5 g
16031683|NCT02654301|Dietary Supplement|Control|sucrose 50 g + deionized water 100 g
16031684|NCT02654288|Other|gemcitabine-based chemotherapy|
16031685|NCT02654275|Other|Proprioceptive Intervention|
16031686|NCT02654249|Device|Transanal hemorrhoidal dearterialization + mucopexy (THD).|Using an anoscope combined with a Doppler transducer the hemorrhoidal arteries are identified and ligated to decrease the blood flow to the hemorrhoidal plexus. In order to reduce hemorroidal prolapse a mucopexy is performed.
16031687|NCT02654249|Procedure|Ligasure™ hemorrhoidectomy|Excisional hemorroidectomy performed with Ligasure™
16031688|NCT02654249|Device|THD anoscope and doppler|An dedicated anoscope with an incorporated doppler probe sold by THD Lab S.p.A will be used for the THD procedure
16031689|NCT02654249|Device|Ligasure Vessel Sealing|A curved, small jaw, open sealer/divider sold by Covidien/medtronic will be used for the Ligasure™ hemorrhoidectomy
16031690|NCT02654236|Drug|Placebo|1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 4 weeks.
16031691|NCT02654236|Drug|10 mg Obeticholic Acid (OCA)|10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 4 weeks.
16031692|NCT02654223|Biological|MG56 Mannosylated 60 subcutaneous|Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 60 MTU(Mannosylated Therapeutic Units)/ml subcutaneous
16031693|NCT02654223|Biological|MG56 Mannosylated 100 subcutaneous|Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 100 MTU(Mannosylated Therapeutic Units)/ml subcutaneous
16031694|NCT02654223|Biological|MG56 Mannosylated 300 subcutaneous|Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 300 MTU(Mannosylated Therapeutic Units)/ml subcutaneous
16031695|NCT02654223|Biological|MG56 Mannosylated 500 subcutaneous|Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 500 MTU(Mannosylated Therapeutic Units)/ml subcutaneous
16031696|NCT02654223|Biological|MG56 Mannosylated 60 sublingual|Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 60 MTU(Mannosylated Therapeutic Units)/ml sublingual
16031697|NCT02654223|Biological|MG56 Mannosylated 100 sublingual|Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 100 MTU(Mannosylated Therapeutic Units)/ml sublingual
16031791|NCT02653638|Other|Control|"Transcranial Doppler
~Blood Pressure
~Heart Rate
~Oxygen Saturation"
16031698|NCT02654223|Biological|MG56 Mannosylated 300 sublingual|Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 300 MTU(Mannosylated Therapeutic Units)/ml sublingual
16031699|NCT02654223|Biological|MG56 Mannosylated 500 sublingual|Mixture of the following pollens: Phleum pratense, Dactylis glomerata, allergen extract with a concentration of 500 MTU(Mannosylated Therapeutic Units)/ml sublingual
16031700|NCT02654223|Biological|Subcutaneous placebo|Comparison between placebo and active group
16031701|NCT02654223|Biological|Sublingual placebo|Comparison between placebo and active group
16031702|NCT02654210|Other|No Intervention|No Intervention
16031703|NCT02654184|Procedure|supine position|Anesthesia induction with sevoflurane for the patient while he is in supine position.
16031704|NCT02654184|Procedure|Right lateral position|Anesthesia induction with sevoflurane for the patient while he is in right lateral position.
16031705|NCT02654171|Drug|AK0529|AK0529 is a novel compound being developed for the treatment of RSV infection. The enteric coated drug pellets with sugar core can be administered orally with apple sauce/purée or yoghurt, or by flushing with 10% dextrose water via a nasogastric or other feeding tube, or upon a glucose wafer.
16031706|NCT02654171|Drug|Placebo|The placebo was made with the same smell and appearance as AK0529 but without the active ingredients. The placebo supplements are composed primarily of microcrystaline cellulose pellet.
16031707|NCT02654158|Drug|Low-dose of Fuganlin Oral Liquid|"less than 1 years old: 5mL each time and three times a day
~1~3 years old: 10mL each time and three times a day
~4~6 years old: 10mL each time and four times a day
~7~12 years old: 10mL each time and five times a day"
16031708|NCT02654158|Drug|High-dose of Fuganlin Oral Liquid|"less than 1 years old: 10mL each time and three times a day
~1~3 years old: 20mL each time and three times a day
~4~6 years old: 20mL each time and four times a day
~7~12 years old: 20mL each time and five times a day"
16031709|NCT02654145|Drug|Mepolizumab 100mg SC|At Visit 2 (Week 0) eligible subjects will receive mepolizumab 100mg SC into the upper arm or thigh every 4 weeks over a period of 28 weeks.
16031710|NCT02654145|Drug|Albuterol/salbutamol MDIs|Albuterol/salbutamol metered dose inhalers (MDIs) will be provided as rescue medication during treatment period.
16031711|NCT02654145|Drug|Omalizumab|Subjects receiving omalizumab will enter in a run-in period and will continue to receive omalizumab throughout the run-in period. At Visit 2 (week 0) subjects will discontinue omalizumab.
16031712|NCT02654132|Drug|Elotuzumab|
16031713|NCT02654132|Drug|Pomalidomide|
16031714|NCT02654132|Drug|Dexamethasone|
16031715|NCT02654119|Drug|Cyclophosphamide|Given IV
16031716|NCT02654119|Other|Laboratory Biomarker Analysis|Correlative studies
16031717|NCT02654119|Drug|Paclitaxel|Given IV
16031718|NCT02654119|Biological|Trastuzumab|Given IV
16031719|NCT02654106|Radiation|Fractionated Stereotactic Radiotherapy|The regular fraction modes were as follows: a. lesions≥3 cm：52Gy/4Gy/13f or 52.5Gy/3.5Gy/15f; b. lesions<2cm：36Gy/12Gy/3f or 24Gy/24Gy/1f; for lesions located in function areas, it would be adjusted to 40Gy/8Gy/5f; c. lesions 2-3cm：40-48Gy/8-10Gy/6-4f; d. lesions located in brainstem：50-60Gy/2.5-3Gy/20f.
16031720|NCT02654106|Drug|Temozolomide|concomitant TMZ: 75mg/m2 adjuvant TMZ: 150mg/m2*5d, q28d, 6cycles
16031721|NCT02654093|Drug|Cholecalciferol|
16031722|NCT02654093|Drug|Raloxifene|
16031723|NCT02654093|Drug|Cholecalciferol and Raloxifene co-administration|
16031724|NCT02654080|Biological|HIV-1 nef/tat/vif, env pDNA vaccine|1500 mcg to be administered as 0.5 mL intramuscular (IM) in the deltoid of the non-dominant arm (unless medically contraindicated) using the Ichor Medical Systems TDS EP device
16031725|NCT02654080|Biological|rVSV HIV envC vaccine|1 × 10^7 PFU to be administered as 1 mL IM in the deltoid of the non-dominant arm (unless medically contraindicated)
16031726|NCT02654080|Biological|Placebo|"Sodium Chloride for Injection, USP 0.9%;
~At Months 0, 1, and 3: administered as 0.5 mL IM in the deltoid of the non-dominant arm (unless medically contraindicated) using the Ichor Medical Systems TDS EP device.
~At Months 6 and 9: administered as 1 mL IM in the deltoid of the non-dominant arm (unless medically contraindicated)."
16031727|NCT02654067|Procedure|photograph|photograph of airway
16031728|NCT02654054|Drug|Elagolix|Film-coated tablets
16031729|NCT02654054|Drug|Placebo for Estradiol/Norethindrone Acetate|Placebo capsules
16031730|NCT02654054|Drug|Estradiol/Norethindrone Acetate|Commercially-available E2/NETA tablets were over-encapsulated to maintain study blinding.
16031731|NCT02654054|Drug|Placebo for Elagolix|Film-coated placebo tablets
16031732|NCT02654041|Drug|Combined T3 and Methimazole treatment|Oral administration of T3 and Methimazole
16031733|NCT02654028|Procedure|Autotransfusion|These group of patients will receive autotransfusion before liver resection.
16031734|NCT02654028|Other|Control group|These group of patients will not receive autotransfusion before or after liver resection.
16031737|NCT02654002|Drug|Cilofexor|Tablets administered orally
16031738|NCT02654002|Drug|Placebo|Tablets administered orally
16031739|NCT02653989|Biological|MDV9300|MDV9300 will be administered at a dose of 200 mg by intravenous (IV) infusion every 2 weeks until treatment discontinuation criteria are met.
16031740|NCT02653976|Drug|SP-02L (darinaparsin for injection)|Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days
16031741|NCT02653963|Drug|Adjunctival Triamcinolone|Intraoperative Periplate 10 mg Triamcinolone Injection during AGV Implantation
16031742|NCT02653950|Procedure|Endoscopic septoplasty|Endoscopic surgery; septoplasty with or without middle turbenectomy
16031743|NCT02653950|Procedure|Traditional septoplasty|septoplasty under direct vision
16031744|NCT02653937|Drug|Tsumura's shigyakusan|"Shigyakusan appears in the early 3rd Century. Four herbal crude medicines included are the following:
~Root of Bupleurum falcatum L Unripe fruit of Citrus aurantium Linne var. daidai Makino, Citrus aurantium Linne, or Citrus natsu-daidai Hayata (Rutaceae) Root of Paeonia lactiflora Pall Root and stolon of Glycyrrhiza uralensis Fisher or Glycyrrhiza glabra Linne"
16031792|NCT02653638|Drug|Indomethacin|"Transcranial Doppler
~Blood Pressure
~Heart Rate
~Oxygen Saturation"
16031745|NCT02653924|Other|silk suture|each treatment will include 4 types of suture (as described above). all subjects will receive the same types of sutures. treatment plan is NOT influenced by the suture material used.
16031746|NCT02653924|Other|vicryl suture|each treatment will include 4 types of suture (as described above). all subjects will receive the same types of sutures. treatment plan is NOT influenced by the suture material used.
16031747|NCT02653924|Other|nylon suture|each treatment will include 4 types of suture (as described above). all subjects will receive the same types of sutures. treatment plan is NOT influenced by the suture material used.
16031748|NCT02653924|Other|polypropylene suture|each treatment will include 4 types of suture (as described above). all subjects will receive the same types of sutures. treatment plan is NOT influenced by the suture material used.
16031749|NCT02653911|Other|Acupuncture|Hwato Brand, Suzhou Medical Appliance Factory, China
16031750|NCT02653911|Other|Sham-acupuncture group|Hwato Brand, Suzhou Medical Appliance Factory, China
16031751|NCT02653898|Drug|DHA-PIP|Administered monthly (weight-based) on days 1-3, during months 1, 2, and 3 in the MMP arm and also as a first line agent for P.v malaria recurrence in both MMP and FSAT treatment arms
16031752|NCT02653898|Drug|Primaquine|22.5 mg weekly for 12 weeks in the MMP arm; low dose primaquine (15mg) for transmission blocking of P. falciparum or 14 days of primaquine (15mg) in G6PD normal volunteers or 8 weeks of low dose primaquine (45mg) in G6PD-deficient volunteers for radical cure of P. vivax
16031753|NCT02653898|Drug|Artesunate + Mefloquine|Weight based; first line agent for P.f malaria infection diagnosed at monthly follow ups, administered on days 1-3 in subjects with malaria recurrence
16031754|NCT02653898|Drug|Permethrin (Insecticide treated uniform)|40% Permethrin IDA kit, applied once to the uniforms for volunteers assigned to ITU arm
16031755|NCT02653885|Other|Red red cell distribution width|Results from hemogram
16031756|NCT02653872|Drug|AZD7986|Oral solution, single dose, dilution from concentrate
16031757|NCT02653872|Drug|Verapamil|Extended release tablet for oral use
16031758|NCT02653872|Drug|Itraconazole|Oral solution
16031759|NCT02653872|Drug|Diltiazem|Extended release capsule
16031760|NCT02653846|Procedure|RT-2D-SWE measurement|measurement of liver and spleen stiffness by ultrasound real-time 2D shear wave elastography (SWE™)
16031761|NCT02653846|Procedure|HVPG measurement|assessment of portal hypertension assessed by hepatic venous pressure gradient measurement
16031762|NCT02653833|Drug|Tadalafil 20 MG|Blood flow to the forearm is visualized via an ultrasound technique at rest and with graded exercise. The experiment is then repeated shortly after the subject takes the study agent, beetroot juice extract.
16031763|NCT02653833|Other|beetroot juice extract|Blood flow to the forearm is visualized via an ultrasound technique at rest and with graded exercise. The experiment is then repeated shortly after the subject takes the study agent, beetroot juice extract.
16031764|NCT02653820|Other|Reflexology|
16031765|NCT02653807|Other|mobilization with movement|manual therapy intervention
16031766|NCT02653807|Other|osteopathic mobilization|manual therapy intervention
16031767|NCT02653781|Behavioral|Realistic simulation|The students enrolled and selected according to the inclusion criteria will be randomized into two groups. The experimental group will experience the combined teaching methodology: dialogue-exhibition and realistic simulation.
16031768|NCT02653781|Behavioral|control group|The control group will have contents exposed solely from the dialogue-exhibition.
16031769|NCT02653781|Behavioral|Simulation workshop|Check the performance of students in face of simulated situations on medication administration by intramuscular and intravenous routes experienced in the Skills and Care Simulation Laboratory.
16031770|NCT02653781|Behavioral|Test realistic simulation|Occurs after the end of the three-month intervention. At that time, students from the control and intervention groups will be asked to take a knowledge retention test in cognitive assessment format and OSCE format (objective structured clinical examination).
16031771|NCT02653768|Behavioral|Stepped Exercise Program|"STEP 1: Participants have access to an internet-based exercise program for knee OA.
~STEP 2: Participants have access to an internet-based exercise program for knee OA plus telephone support.
~STEP 3: Participants have access to an internet-based exercise program for knee OA plus in-person physical therapy visit"
16031772|NCT02653768|Behavioral|Arthritis Education|The arthritis education intervention will include bi-weekly mailings of low-literacy educational materials on a comprehensive set of topics related to OA and its management, based on established treatment guidelines.
16031773|NCT02653755|Device|Prosigna|Transcriptional profile of 50 genes used for risk stratification.
16031774|NCT02653742|Drug|Ketorolac|Ketorolac 1mg/kg sublingual is administered after induction of general anesthesia.
16031775|NCT02653742|Drug|Fentanyl|Fentanyl 2mg/kg intranasal is administered after induction of general anesthesia
16031776|NCT02653729|Behavioral|cognitive behaviour therapy|
16031777|NCT02653729|Drug|Espidone|
16031778|NCT02653729|Drug|Olepra|
16031779|NCT02653729|Drug|Donu|
16031780|NCT02653716|Behavioral|New Orleans Intervention Method|An attachment based assessment, then a tailored intervention aimed at maximising the chances of the maltreated child being returned to the birth family
16031781|NCT02653716|Behavioral|Case Management|A social work assessment of family functioning that makes future recommendations regarding the future placement of a maltreated child.
16031782|NCT02653703|Other|Topical L-menthol 40%|Naturally occurring local anaesthetic, counterirritant and TPRM8-agonist. CAS Number: 2216-51-5
16031783|NCT02653703|Other|Vehicle, topical ethanol 96%|Organic solvent CAS Number: 64-17-5
16031784|NCT02653677|Other|intake of the specific kind of bread|To determine the glycemic and insulinemic responses (area-under the curve, AUCs), the satiety rate and the AUCs of free fatty acids (FFA), triglycerides and ghrelin after the ingestion of four types of breads, each containing 50g of available carbohydrates
16031788|NCT02653651|Drug|Ketamine|Ketamine infused at 0.1 mg/kg/hour
16031789|NCT02653651|Drug|Lidocaine|Lidocaine infused at 1 mg/kg/hour
16031790|NCT02653651|Drug|Placebo|An equal volume of saline
16149601|NCT01784302|Drug|Raltegravir 400 mg|
16031793|NCT02653625|Drug|Cenicriviroc 150 mg|One tablet of CVC 150 mg once daily taken with food in the morning.
16031794|NCT02653612|Drug|EC17 imaging contrast agent|This is an imaging agent to locate lung adenocarcinoma cancer cells during surgery
16031795|NCT02653599|Drug|TTP273|
16031796|NCT02653599|Drug|Placebo|
16031797|NCT02653586|Other|"program In Favor of Resilience Self"|A prevention program aiming at improve self-resilience ,self-esteem and body image, contains nine interactive activities, based on a cognitive dissonance method.
16031798|NCT02653573|Behavioral|Coaching|Self-management education
16031799|NCT02653560|Drug|Potassium chloride powder|
16031800|NCT02653560|Drug|Potassium magnesium Citrate (KMgCit)|
16031801|NCT02653560|Drug|Potassium citrate powder|
16031802|NCT02653560|Drug|Placebo|
16031803|NCT02653547|Other|standard multisite four weeks|Repetitive transcranial magnetic stimulation (Magventure): 1000 stimuli of 20 Hz rTMS over the left DLPFC (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over the left temporoparietal cortex (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over right temporoparietal cortex (110% motor threshold). Patients continue treatment after two weeks for further two weeks of treatment (20 treatment days).
16031804|NCT02653547|Other|high-frequency multisite four weeks|Repetitive transcranial magnetic stimulation (Magventure): 1000 stimuli of 20 Hz rTMS over the left DLPFC (110% motor threshold) followed by 1000 stimuli of 20 Hz rTMS over the left temporoparietal cortex (110% motor threshold) followed by 1000 stimuli of 20 Hz rTMS over right temporoparietal cortex (110% motor threshold). Patients continue treatment after two weeks for further two weeks of treatment (20 treatment days).
16031805|NCT02653547|Other|standard multisite two weeks|Repetitive transcranial magnetic stimulation (Magventure): 1000 stimuli of 20 Hz rTMS over the left DLPFC (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over the left temporoparietal cortex (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over right temporoparietal cortex (110% motor threshold). Patients discontinue treatment after two weeks (10 treatment days).
16031806|NCT02653547|Other|high-frequency multisite two weeks|Repetitive transcranial magnetic stimulation (Magventure): 1000 stimuli of 20 Hz rTMS over the left DLPFC (110% motor threshold) followed by 1000 stimuli of 20 Hz rTMS over the left temporoparietal cortex (110% motor threshold) followed by 1000 stimuli of 20 Hz rTMS over right temporoparietal cortex (110% motor threshold). Patients discontinue treatment after two weeks (10 treatment days).
16031807|NCT02653534|Behavioral|Kangaroo Mother Care|Promotion of, and support for lactation management and skin to skin care as soon as possible after birth by study ANM supported by study ASHA in addition to routine visits by government health workers
16031808|NCT02653521|Radiation|Dose adaptation|Replanning the treatment to adapt the change of PTV and movement of OARs to achieve an optimal dose distribution using online CBCT images.
16031809|NCT02653508|Behavioral|Diet and Activity|During all the following meetings, before the initiation of the training sessions, 10 to 15 minutes were devoted to an interactive discussion with participants on food pyramid, food choices, food labels, food preparation and cooking, eating habits, regular meals, controlling environments that stimulate overeating. All adolescents participated in a three-day per week training programme (45 minutes per training session). Many activities were delivered as games in order to encourage enthusiasm and participation. Endurance type activities accounted for most of the time spent in training (about 50% team sports and 50% running games), with attention to coordination and flexibility skills.
16031810|NCT02653508|Behavioral|Activity|All adolescents participated in a three-day per week training programme (45 minutes per training session). Training was directed by a professional teacher of physical education in a public training centre. The training program was designed according to the type and intensity of exercise that school children normally perform. Many activities were delivered as games in order to encourage enthusiasm and participation. Endurance type activities accounted for most of the time spent in training (about 50% team sports and 50% running games), with attention to coordination and flexibility skills. In order to encourage adolescents' behaviour change, they were instructed to add an extra 30-45 minutes of walking or other sport activity of their preference at least once a week and to reduce inactivity
16031811|NCT02653495|Biological|Influenza vaccine|Influenza vaccine administered intramuscularly (IM), 1 time only, on visit 3
16031812|NCT02653482|Drug|Dapagliflozin|
16031813|NCT02653482|Drug|Dapagliflozin matching placebo|
16031814|NCT02653469|Other|Augmented ventilation|When the patient's PPV is within grey zone, patient's tidal volume is maintained with augmented tidal volume of 12 ml/kg (from normal ventilation of 8ml/kg) for 2min duration.
16031815|NCT02653469|Other|Fluid loading|We record the stroke volume index (SVI) values before and after volume expansion with 6ml/kg of balanced crystalloid
16031816|NCT02653456|Device|RA-308 Excimer Laser and DABRA Catheter|See information already included in arm description
16031817|NCT02653443|Biological|Autologous apheresis Platelet Components, prepared with the INTERCEPT Blood System for Platelets.|Each subject will provide two apheresis platelet donations (one per period) and receive two infusions (one per period) of autologous radiolabeled fresh platelets combined with INTERCEPT treated platelet components stored for either 6 or 7 days (approximately 10 to 30 mL). Platelets are administered by intravenous infusion in a peripheral vein via 19-gauge butterfly infusion needle.
16031818|NCT02653443|Biological|Autologous apheresis Conventional untreated Platelet Components|Each subject will provide two apheresis platelet donations (one per period) and receive two infusions (one per period) of autologous radiolabeled fresh platelets combined with conventional untreated platelet components stored for either 6 or 7 days (approximately 10 to 30 mL). Platelets are administered by intravenous infusion in a peripheral vein via 19-gauge butterfly infusion needle.
16031819|NCT02653430|Procedure|Sleeve gastrectomy|"After complete exams such as EKG，UCG，spirometry and other basic exams,estimate the condition of patient whether he(she) can tolerate a surgical operation.Then we operate theSleeve gastrectomy laparoscopically by a group of experienced surgeons."
16031820|NCT02653417|Drug|RAD1901|RAD1901
16031821|NCT02653417|Other|Placebo|Placebo
16031822|NCT02653404|Other|IGRA test (QTF-GIT)|blood sample for QFT-GIT will be taken together with other routine blood samples
16031823|NCT02653391|Drug|Part A Elamipretide 1.0% Ophthalmic Solution|Part A Each subject will receive one drop of elamipretide 1.0% ophthalmic solution BID in the randomly selected study eye.
16032569|NCT02648087|Device|With and without SDB|Screening of sleep-disordered breathing (SDB)
16031824|NCT02653391|Drug|Part B Elamipretide 3.0% Ophthalmic Solution|Part B Each subject will receive one drop of elamipretide 3.0% ophthalmic solution BID in both eyes.
16031825|NCT02653391|Drug|Part A Placebo|Part A Each subject will receive one drop of vehicle ophthalmic solution BID in the paired eye of the randomly selected study eye.
16031826|NCT02653391|Drug|Part B Placebo|Part B: Each subject will receive one drop of vehicle ophthalmic solution BID in both eyes.
16031827|NCT02653378|Behavioral|DIET|25% Energy Depletion by Diet only for 3 Days
16031828|NCT02653378|Behavioral|EX|25% Energy Depletion by Exercise only for 3 Days
16031829|NCT02653365|Device|Non-invasive ventilation|Noninvasive ventilation (NIV) was performed with a noninvasive ventilator (BiPAP Synchrony®, Respironics Inc., Murrysville, PA, USA).
16031830|NCT02653352|Behavioral|Lifestyle modification|The centre of the campaign was to encourage the exchange of sugar-sweetened beverages for water. Ten one-hour sessions of activities facilitated by four trained research assistants were assigned for each class. The activities required 20-30 min and teachers were encouraged to reiterate the message during their lesson. Classroom quizzes and games using water v. sugar-sweetened carbonated beverages as the theme, as well as song and drawing competitions, were promoted. In addition, a musician using a tambourine helped each class to collectively develop songs related to drinking water and reducing the consumption of sugar-sweetened carbonated beverages. This musical activity was conducted during three one-hour sessions.
16031831|NCT02653339|Drug|Qufeng Shengshi Fang and Loratadine|"The patients with allergic rhinitis are divided into two groups, one is experimental group, and the other is control group.
~The experimental group patients are treated with Qufeng by oral, 200ml two times a day and Loratadine by oral,10mg QD"
16031832|NCT02653339|Drug|Loratadine|"The patients with allergic rhinitis are divided into two groups, one is experimental group, and the other is control group.
~The control group patients are treated with Loratadine by oral, 10mg QD"
16031833|NCT02653326|Device|Telerehabilitation Monitors|After completing a 12-session physical therapy programme and the aforementioned co-interventions, patients will receive a telerehabilitation strategy comprised by electrocardiographic monitoring and a smartphone application aimed at detecting adverse events during exercise activities. These devices will also inform patients and healthcare providers regarding the adequacy of their physical activities in terms of cardiovascular outcomes and the observed changes during treatment.
16031834|NCT02653326|Procedure|Physical Therapy|Physical therapy will be provided in form of twelve 90-minute sessions. Exercises will be tailored to patient needs, but a common goal of reaching an oxygen consumption of 80-90% will be used for every participant.
16031835|NCT02653326|Behavioral|Nutritional Counseling|Nutritional counseling will be provided in 60-minute group sessions for included participants. A nutritionist will provide education in terms of healthy eating and risk factor modification.
16031836|NCT02653326|Other|Depression Screening|Participants will be screened for depression using the Hospital Anxiety and Depression scale, which has been validated for Spanish-speaking countries. If depression is confirmed, pharmacologic treatment and/or psychotherapy will be prescribed at the discretion of the attending physician.
16031837|NCT02653326|Drug|Treatment of Comorbidities|Whenever needed, treatment of comorbid conditions, such as hypertension, diabetes or dyslipidemia, will be provided for study participants.
16031838|NCT02653313|Drug|Parvovirus H-1 (H-1PV)|"Parvovirus H-1 administered at three increasing dose levels , according to the following schedule: i) 4 daily intravenous infusions of 10% of the total dose over 2 hours on 4 consecutive days, ii) direct injection of 60% of the total dose into a hepatic metastasis of the pancreatic cancer.
~The total dose levels are: 1E09, 5E09 and 1E10 pfu."
16031839|NCT02653300|Biological|Oral Insulin|all patients will receive treatment regimen of a soft gel capsule of ORMD-0801.
16031840|NCT02653287|Behavioral|Experimental|The experimental intervention includes 4 individual coaching sessions (initial 1 hour in-person and remaining 10-15 minutes per telephone) designed to identify barriers and supports for physical activity and nutrition using motivational interviewing. They occur shortly after randomization, 1.5, 3, and 6 months. Daily participants monitor their physical activity via the Fitbit Flex and their dietary behavior on a paper diary.
16031841|NCT02653287|Other|Control|The control group will receive four individual phone calls focusing on education for SLE disease management, as well as answering any questions the participants have about the study. Topics include: what is lupus, laboratory tests, medications, taking charge of your health care and managing stress (2 sessions). Each call will last about 10-15 minutes, and occur shortly after randomization, then at 1.5, 3, and 6 months.
16031842|NCT02653274|Other|Breakfast porridge|220 kcal breakfast porridge served with 240 mL glass of water
16031843|NCT02653261|Drug|Tranexamic Acid|Tranexamic acid (TXA) is a synthetic analog of serin than reversibly inhibits fibrinolysis by blocking lysine union sites in the plasmin and plasminogen activator molecules. TXA: bolus of 10 mg/kg thirty minutes before resection followed by infusion of 1 mg/kg/h intraoperatively and for 24 h postoperatively
16031844|NCT02653261|Drug|Placebo|An equal volume of saline
16031845|NCT02653248|Radiation|Stereotactic Body Radiation Therapy|Patients will receive 5 fractions of SBRT radiation, treated every other day. No more than three fractions per week. Total dose will depend on cohort. Cohort 1: 40Gy, Cohort 2: 45 Gy, Cohort 3: 50 Gy.
16031846|NCT02653235|Biological|Salmonella typhi vaccination|
16031847|NCT02653235|Biological|Placebo|
16031848|NCT02653222|Procedure|Renal sympathicolysis|
16031849|NCT02653222|Procedure|Ambulatory Blood Pressure Monitoring|1 month before and after surgery the patient will have an ABPM over 24h
16031850|NCT02653222|Radiation|Magnetic Resonance Angiography|1 month before and after surgery the patient will have a MRA
16031851|NCT02653222|Biological|Blood test|complete blood count, blood platelets, coagulation profile, irregular agglutinins search
16031852|NCT02653209|Drug|Sitagliptin - DPP4i|DPP4 inhibitor 100mg supplied as over-encapsulated hard capsule shell to be taken orally, once a day for 16 weeks in addition to existing prescribed oral diabetes therapy.
16031853|NCT02653209|Drug|Canagliflozin - SGLT2i|SGLT2 inhibitor 100mg supplied as over-encapsulated hard capsule shell to be taken orally, once a day for 16 weeks in addition to existing prescribed oral diabetes therapy.
16031854|NCT02653209|Drug|Pioglitazone - TZD|Thiazolidinedione 30mg supplied as over-encapsulated hard capsule shell to be taken orally, once a day for 16 weeks in addition to existing prescribed oral diabetes therapy.
16032658|NCT02647398|Behavioral|Vigorous aerobic training|Supervised vigorous aerobic training
16031855|NCT02653196|Procedure|Allogeneic hematopoietic stem cell transplant following thiotepa-based marrow ablative chemotherapy|Allogeneic hematopoietic stem cell transplant (HSCT) following thiotepa-based marrow ablative chemotherapy (MAC) for children with high-grade and/or recurrent neuro-epithelial and other solid tumors.
16031856|NCT02653196|Drug|Keratinocyte Growth Factor|KGF 60 mcg/kg IV: 6 doses
16031857|NCT02653196|Drug|Alemtuzumab|Alemtuzumab 12 mg/m2 IV: 2 doses (not given if matched related donor is 10/10 HLA matched sibling donor)
16031858|NCT02653196|Drug|Thiotepa|Thiotepa 300 mg/m2 IV: 3 doses
16031859|NCT02653196|Drug|Etoposide|Etoposide 100 mg/m2 IV: 3 doses
16031860|NCT02653196|Drug|Fludarabine|Fludarabine 30 mg/m2 IV: 3 doses
16031861|NCT02653196|Drug|Melphalan|Melphalan 70 mg/m2 IV: Day 2 doses
16031862|NCT02653196|Drug|Tacrolimus|Tacrolimus 0.05 mg/kg/day IV (Cyclosporine may be substituted for Tacrolimus): Start Day -2, begin taper on Day +100, discontinue on Day +180
16031863|NCT02653196|Drug|Cyclosporine A|Cyclosporine A dosed as follows: Age ≤ 6 years: 6 mg/kg/day IV in divided doses (e.g. 2 mg/kg every 8 hours) OR Age > 6 years: 3 mg/kg/day IV in divided doses (1.5 mg/kg every 12 hours): Start Day -2, begin taper on Day +100, discontinue on Day +180
16031864|NCT02653196|Drug|Mycophenolate mofetil|Mycophenolate mofetil 15 mg/kg every 8 hours oral or IV: Start Day 0 (4-6 hours post stem cell infusion) to Day +40, then taper weekly until discontinuation on Day +90
16031865|NCT02653183|Device|Active Comparator: Aquacel Surgical|Post-operative all-in-one self-adherent soft silicone coated foam dressing. Duration of treatment: Total 5 days included the day of surgery and 4 post-operative days.
16031866|NCT02653183|Device|Experimental: Mepilex Border Post-Op|"Aquacel Surgical is a sterile, one piece post-operative dressing.Duration of treatment:
~Total 5 days included the day of surgery and 4 post-operative days."
16031867|NCT02653170|Other|SCM|"One intervention (SCM) is provided. Stroke Case Managers (SCMs) will conduct 2 home visits; the first within 72-96 hours and the other after 30-days of returning home. SCMs will conduct weekly follow-up phone calls. Additional home visits are permitted if needed. Home visit activities include:
~Biopsychosocial assessment of patient and caregiver needs.
~Set up appointments.
~Assist scheduling appointments with primary care physician and other medical providers.
~Promote medication adherence through medication tool kits, pill organizers and other aids.
~Facilitate patient and caregiver engagement and activation.
~Facilitate access to social and community services."
16031868|NCT02653170|Other|SCM and VSSP|"SCM: Stroke Case Managers (SCMs) will conduct home visits at 72-96 hours and after 30-days. SCMs will conduct weekly follow-up phone calls. Additional home visits are permitted as needed. Activities include:
~Biopsychosocial assessment of patient and caregiver needs.
~Set up appointments.
~Assist scheduling appointments with primary care physician and other medical providers.
~Promote medication adherence through medication tool kits, pill organizers and other aids.
~Facilitate patient and caregiver engagement and activation.
~Facilitate access to social and community services.
~VSSP: Access and training on the Virtual Stroke Support Portal, an online information and support website which includes:
~Contact list of care team members.
~Access to hospital patient portal.
~Stroke education materials, resources, and guidelines.
~Access to Michigan 2-1-1 services.
~Medication information and adherence tools.
~Patient and Caregiver support networks."
16031869|NCT02653157|Other|MDR-GNB|
16031870|NCT02653144|Drug|Ropivacaine|local anesthetics adjuvants. Ropivacaine 0.5% 20ml. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
16031871|NCT02653144|Drug|Dexmedetomidine|local anesthetics adjuvants. 75mcg of dexmedetomidine. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
16031872|NCT02653144|Drug|Dexamethasone|local anesthetics adjuvants. 4mg dexamethasone. pre-operative single shot interscalene nerve block under ultrasound guidance and peripheral nerve stimulation in patients undergoing ambulatory shoulder surgery
16031873|NCT02653131|Drug|Dipeptidyl peptidase-4 inhibitor|
16031874|NCT02653118|Biological|V503|
16031875|NCT02653118|Biological|GARDASIL|
16031876|NCT02653105|Biological|OLFM4|patient have an additional blood test every 6 months for dosing OLFM4
16031883|NCT02653079|Other|Blood Draw and Questionaire|The study is observational. The treatment-plan of the underlying disease remained unchanged. Blood draw from patients at several time points during and after low dose radiation therapy.
16031884|NCT02653066|Other|HealtheRx+|Participant receives $5 bill with incentive check and blank consent form
16031885|NCT02653066|Other|HealtheRx++|Participant receives $5 bill when they returned signed PRR consent form.
16031886|NCT02653040|Other|Dynamic lighting|"Intervention is rooms with light settings imitating natural light conditions with white light at day and low-lux no-blue light at night:
~07am-10am: white light, increasing intensity 10am-07pm: white light, full intensity 07pm-11pm: no blue wavelength, low intensity 11pm-07am: no blue wavelength, very low intensity"
16031887|NCT02653027|Drug|Lumacaftor-ivacaftor|Subjects who are planning on starting the combination therapy (lumacaftor-ivacaftor) will participate in OGTTs before and after starting the medication.
16031888|NCT02653027|Other|OGTT|A subject is given an oral glucose load and insulin and glucose measurements are taken at specified time periods.
16031889|NCT02653014|Drug|KBP-5074|
16031890|NCT02653001|Other|Stool sample collection|Collection of complete stool sample
16031891|NCT02652988|Other|Active-tDCS|Active home-based tDCS applied at home.
16031892|NCT02652988|Other|Sham-tDCS|Sham home-based tDCS applied at home.
16031922|NCT02652780|Device|Sham Intravitreal Injection|"Both eyes of each participant will receive standard antiseptic preparation, administration of topical local ocular anesthetic agents and will undergo pupillary dilation. Administration of an intra-ocular pressure lowering agent will precede treatment for every participant.
~Sham-treated Eyes: One eye of each participant will undergo sham injection. Sham Intravitreal injection will be performed by applying pressure to the eye at the location of a typical intravitreal injection procedure using the blunt end of a syringe without a needle."
16150455|NCT01777412|Drug|Bevacizumab|
16031893|NCT02652975|Procedure|Venous occlusion plethysmography|To characterize endothelial function in vivo the effect of vasodilatating substances is measured in the forearm circuit. The substances is administered via a thin catheter placed in the Brachial artery near the elbow in local anesthesia. Once the vessels dilate, the blood flow in the forearm will increase and the flow change is a measure of the vasodilatory capacity of that substance. The change is measured with classical venous occlusion plethysmography. The method described is established at Aarhus University Hospital and has been used for several decades to illustrate the effect of vasoactive drugs on the human circulation, meaning it is a proven and well documented method.
16031894|NCT02652975|Procedure|SphygmoCor|"Applanation tonometry (pulse wave velocity and central blood pressure/arterial stiffness): The central blood pressure and the augmentation index is estimated from the shape of the radial pulse wave measured with a tonometer.
~Pulse wave velocity (PWV) is calculated from the average difference between the pulse pressure wave measured with a tonometer and the R in an ECG recorded simultaneously."
16031895|NCT02652975|Procedure|24hour blood pressure|24 hour blood pressure measurement
16031896|NCT02652975|Procedure|DEXA scan|Measurements of body composition: Total body fat and fat free mass is measured by Dual Energy X-ray Absorptiometry (DEXA).
16031897|NCT02652975|Biological|Laboratory blood samples|"Fasting blood tests are drawn from an antecubital placed catheter (albumin, ALAT/ASAT, alkaline phosphatase, bilirubin, gammaglutamyl transferase, coagulation factors, red and white blood cells, creatinin, potassium, sodium, fasting lipids, fasting glucose, hemoglobin A1C, insulin, sex hormones, von Willebrand factor, low grade inflammation markers, DNA and RNA for later analyses, including relevant coding genes).
~Further more urine samples to determine possible systemic impact of cardiovascular disease.
~We will create a biobank containing urine and blood samples from participants for future research, provided that the participant gives her permission.
~Responsibility for the biobank lies with the project responsible physician, Anders Bonde Jensen."
16031898|NCT02652962|Device|Gelesis200|3 capsules each containing 0.70 g
16031899|NCT02652962|Other|Placebo|3 capsules each containing 0.57 g of a mixture of microcrystalline cellulose and maltodextrin in a ratio of approximately 50 ± 10%
16031900|NCT02652949|Device|Valiant Evo Thoracic Stent Graft System|Procedure: thoracic endovascular aneurysm repair (TEVAR)
16031901|NCT02652936|Drug|AF-130|AF-130 oral capsules (50 mg) administered as a single dose or once daily for 7 days
16031902|NCT02652936|Drug|Placebo comparator|AF-130 matching placebo capsule
16031903|NCT02652923|Drug|Sonazoid; Perflubutane for Injection|subdermal injection into the breast of Sonazoid (1 or 2 ml) divided into four individual aliquots at four locations (12, 3, 6, and 9 o'clock)
16031904|NCT02652910|Drug|CD19.CAR-T cells|Retroviral vector-transduced autologous T cells to express CD19-specific CARs
16031905|NCT02652897|Procedure|Exposure to glioma resection surgery|The following blood samples will be drawn for hemostasis evaluation: 1. Conventional clotting tests, 2. Rotational thromboelastometry (ROTEM), including EXTEM and FIBTEM; 3. Platelet function as assessed by PFA-200 for; and 4. Platelet function as assessed by ara-tem, adp-tem and trap-tem. All the analyses will be performed before (within a period 24-h before surgery) and after (within of the following periods: 2 h, 24 h and 48 h after surgery).
16031906|NCT02652897|Procedure|Exposure to colon resection surgery|The following blood samples will be drawn for hemostasis evaluation: 1. Conventional clotting tests, 2. Rotational thromboelastometry (ROTEM), including EXTEM and FIBTEM; 3. Platelet function as assessed by PFA-200 for; and 4. Platelet function as assessed by ara-tem, adp-tem and trap-tem. All the analyses will be performed before (within a period 24-h before surgery) and after (within of the following periods: 2 h, 24 h and 48 h after surgery).
16031907|NCT02652884|Drug|phosphate and betamethasone acetate, 2 mL.|single dose of intramuscular depot corticosteroid
16031908|NCT02652884|Drug|saline 0.9% NaCl|single dose of intramuscular placebo
16031909|NCT02652871|Drug|LY2510924|"Dose Escalation Phase: Starting dose level of LY2510924 is 10 mg subcutaneously each day of a 28 day cycle. Dose escalated in successive cohorts of patients.
~Dose Expansion Phase: LY2510924 given at the maximum tolerated dose (MTD) from Dose Escalation Phase."
16031910|NCT02652871|Drug|Idarubicin|"Dose Escalation Phase: Idarubicin 12 mg/m2 by vein given on Days 8 and 9 of a 28 day cycle. In patients > 60 years of age Idarubicin given for 2 days.
~Dose Expansion Phase: Idarubicin 8 mg/m2 by vein for 2 days."
16031911|NCT02652871|Drug|Cytarabine|"Dose Escalation Phase: Cytarabine 1.5 gm/m2 by vein daily for 4 days (age < 60 years). In patients > 60 years of age Cytarabine given for 3 days only.
~Dose Expansion Phase: Cytarabine 0.75 gm/m2 by vein for 3 days."
16031912|NCT02652858|Procedure|Non-invasive blood pressure oscillometer (NIBP) implementation|Implementation of two additional NIBP on humeral and femoral sites.
16031913|NCT02652845|Behavioral|Wellness Engagement Program|This intervention is an evidence based and community informed program designed to stimulate physical activity and increase healthy food choices among participants. The intervention includes weekly lessons, personal support in the form of biweekly check in calls with a peer support coach and weekly physical activity and nutrition classes.
16031914|NCT02652832|Device|non invasive brain stimulation|non invasive brain stimulation
16031915|NCT02652819|Drug|FG-4592|
16031916|NCT02652819|Drug|Placebo|
16031917|NCT02652806|Drug|FG-4592|
16031918|NCT02652806|Drug|Epoetin Alfa|
16031919|NCT02652793|Drug|Boosted atazanavir|Atanazir 300 mg once dailly boosted with 100 mg of ritonavir once dailly
16031920|NCT02652793|Drug|Lamivudine|Lamivudine 300 mg once dailly
16031921|NCT02652780|Biological|GS010|"Both eyes of each participant will receive standard antiseptic preparation, administration of topical local ocular anesthetic agents and will undergo pupillary dilation. Administration of an intra-ocular pressure lowering agent will precede treatment for every participant.
~GS010-treated Eyes: GS010 is a recombinant adeno-associated viral vector serotype 2 (rAAV2/2) containing the wild-type ND4 gene (rAAV2/2-ND4). Participants will receive a single dose of GS010 in one of their randomly selected eyes, via intravitreal injection containing 9E10 viral genomes in 90μL balanced salt solution (BSS) plus 0.001% Pluronic F68®."
16031959|NCT02652546|Drug|Effect of drug on viral load|Evaluate the effect of CC-11050 on plasma HIV-1 RNA levels by both conventional and single copy assay at week 12 and over all evaluable time points
16031960|NCT02652546|Drug|Effect of drug on T-cell count|Evaluate the effect of CC-11050 on CD4+ T cell counts and percentages at week 12 and over all evaluable time points
16033715|NCT02640053|Other|Quality-of-Life Assessment|Ancillary studies
16031923|NCT02652767|Biological|GS010|"Both eyes of each participant will receive standard antiseptic preparation, administration of topical local ocular anesthetic agents and will undergo pupillary dilation. Administration of an intra-ocular pressure lowering agent will precede treatment for every participant.
~GS010-treated Eyes: GS010 is a recombinant adeno-associated viral vector serotype 2 (rAAV2/2) containing the wild-type ND4 gene (rAAV2/2-ND4). Participants will receive a single dose of GS010 in one of their randomly selected eyes, via intravitreal injection containing 9E10 viral genomes in 90μL balanced salt solution (BSS) plus 0.001% Pluronic F68®."
16031924|NCT02652767|Device|Sham Intravitreal Injection|"Both eyes of each participant will receive standard antiseptic preparation, administration of topical local ocular anesthetic agents and will undergo pupillary dilation. Administration of an intra-ocular pressure lowering agent will precede treatment for every participant.
~Sham-treated Eyes: One eye of each participant will undergo sham injection. Sham intravitreal injection will be performed by applying pressure to the eye at the location of a typical intravitreal injection procedure using the blunt end of a syringe without a needle."
16031925|NCT02652754|Drug|Granexin® gel|Granexin® gel will be dispensed directly from a 5 gram laminate tube and will be spread and smoothed directly over the wound surface in full contact with the wound bed to obtain an even, uniform layer on Day 0 (baseline), Day 3, and Day 7.
16031926|NCT02652741|Drug|Enalapril Orodispersible Minitablet|8-weeks treatment, open, uncontrolled, PK/PD, acceptability and palatability assessments and safety assessments after Enalapril intake in form of 0.25 mg or 1 mg ODMTs
16031927|NCT02652728|Drug|Enalapril Orodispersible Minitablet|Weight-dependent dose titration and long-term treatment scheme with enalapril ODMTs of 0.25 mg and 1 mg strength
16031928|NCT02652715|Other|Laboratory Biomarker Analysis|Correlative studies
16031929|NCT02652715|Other|Quality-of-Life Assessment|Ancillary studies
16031930|NCT02652715|Other|Questionnaire Administration|Ancillary studies
16031931|NCT02652715|Dietary Supplement|Salvia hispanica Seed|Given PO
16031932|NCT02652702|Procedure|circular stapler-assisted colostomy|procedure:circular stapler-assisted colostomy device:circular stapler
16031933|NCT02652702|Procedure|conventional hand-stitching colostomy|procedure:hand-stitching colostomy
16031934|NCT02652689|Radiation|Diagnostic ultrasound radiation|Recording Doppler ultrasound signals from the right chest wall
16031935|NCT02652676|Procedure|Reversible Pulmonary Artery Banding|A sternotomy incision is used for application of the rPAB. Tightening is under echocardiographic control until the inter-ventricular septum becomes a midline structure. Myocardial function is augmented with inotropic and vasodilator agents that are weaned after 2-4 weeks. The infant is separated from mechanical ventilation within the first week, and enteric feeding is resumed. The infant is discharged on oral medications, with follow-ups. Band enlargement is in stages as a balloon catheter-based procedure if a finding of increasing right ventricular dilation, onset or worsening tricuspid valve regurgitation, or a gradual late increase in plasma B-type natriuretic peptide (BNP) levels, opting for a mild residual right ventricle-main pulmonary artery pressure gradient of 15-30 mmHg.
16031936|NCT02652676|Device|GORE-TEX DualMesh EMERGE PLUS Biomaterial|The study is being conducted to evaluate the procedure, not the materials being used. The study uses the patch as materials to create the band around the pulmonary artery which is currently done routinely off label. The patch is approved as a cardiovascular patch. FDA 501(k) K032168.
16031937|NCT02652650|Drug|Ethinylestradiol|Participants will receive 35 microgram (mcg) alone once daily (qd) for 21 days on Days 1 to 21 (Cycle I: lead-in) during first OC cycle; Days 29 to 49 (Cycle II: OC alone, reference) during the second OC cycle and Days 57 to 77 during third OC cycle.
16031938|NCT02652650|Drug|Norethindrone|Participants will receive 1 milligram (mg) alone once daily (qd) for 21 days on Days 1 to 21 (Cycle I: lead-in) during first OC cycle; Days 29 to 49 (Cycle II: OC alone, reference) during the second OC cycle and Days 57 to 77 during third OC cycle.
16031939|NCT02652650|Drug|JNJ-63623872|Participants will receive 600 mg twice daily (bid) for 5 days on Days 73 to 77 (Cycle III: OC plus JNJ-63623872, test) during third OC cycle under fed conditions.
16031940|NCT02652637|Drug|neomycin, metronidazole, polyethylene glycol (PEG)|
16031941|NCT02652624|Drug|E/C/F/TAF|150/150/200/10 mg FDC tablet administered orally once daily with food
16031942|NCT02652624|Drug|E/C/F/TDF|150/150/200/300 mg FDC administered orally once daily with food
16031943|NCT02652624|Drug|ATV|ATV 300 mg capsules administered orally once daily with food
16031944|NCT02652624|Drug|RTV|RTV 100 mg tablets administered orally once daily with food
16031945|NCT02652624|Drug|FTC/TDF|200/300 mg tablet administered orally once daily with food
16031946|NCT02652624|Drug|B/F/TAF|50/200/25 mg FDC tablet administered orally once daily without regard to food
16031947|NCT02652611|Procedure|SI Screw Removal Surgery|
16031948|NCT02652611|Procedure|Non-screw removal treatment (non-operative management)|
16031949|NCT02652598|Drug|Tolcapone|
16031950|NCT02652585|Drug|Naltrexone|
16031951|NCT02652585|Drug|Placebo|capsule filled with micro crystalline cellulose, manufactured to mimic naltrexone capsule
16031952|NCT02652572|Drug|Granexin|Granexin® gel will be dispensed directly from a 5 gram laminate tube and will be spread and smoothed directly over the wound surface in full contact with the wound bed to obtain an even, uniform layer on Day 0 (baseline), Day 3, and Day 7.
16031953|NCT02652559|Device|Transcutaneous measurements of PCO2|PCO2 will be measured transcutaneously with an ear lobe sensor before initiation of NIV, and during the initiation period (SenTec DM®, Software V-STATS 4.0; SenTec AG; Therwil, Switzerland)
16031954|NCT02652559|Device|Telemonitoring|Telemonitoring will be used to send data from the transcutaneous measurements, data from the EMG measurements and data from the ventilator from home to the hospital.
16031955|NCT02652559|Device|EMG|Surface EMG of the respiratory muscles will be used to monit patients in both groups as a surrogate marker of respiratory muscle unloading and to detect PVA during NIV
16031956|NCT02652559|Other|Home initiation of NIV|The primary aim of the study is to compare home and inhospital initiation of NIV
16031957|NCT02652559|Other|Inhospital initiation of NIV|The primary aim of the study is to compare home and inhospital initiation of NIV
16031958|NCT02652546|Drug|Assess Safety|Assess the safety of a 12-week course if CC-1150 in HIV-infected adults who have been on ART for greater than or equal to 1 year and have suppressed plasma viremia
16033716|NCT02640053|Other|Questionnaire Administration|Ancillary studies
16031961|NCT02652546|Drug|Effect of drug on inflammatory biomarkers|Evaluate the effect of CC-11050 on markers of markers of systemic inflammation (TNF, IL-^, CRP, IFNg, sCD14, D-dimer) at week 12 and over all evaluable time points.
16031962|NCT02652533|Device|Ultrasound Shear Wave Elastography|The investigators have recently published a very small study in neonates/infants with suspected BA showing that US liver shear wave speed (i.e. - liver stiffness) can differentiate BA from other causes of cholestasis, potentially with a very high degree of accuracy. Additional research is needed to confirm these very preliminary results and determine if liver shear wave speed measurements either before or after (including longitudinally) Kasai can predict key outcomes.
16031963|NCT02652520|Procedure|HEMO2Life® use in organ preservation solution|The surgeon decides whether the local transplant kidney may be part of the study and whether it should be stored in static cold storage or machine perfusion. The transplant kidney will be perfused in situ before procurement with the Belzer UW® cold storage solution furnish by the BridgetoLife company. HEMO2Life® will then be added to preservation solution.
16031964|NCT02652507|Drug|Dexmedetomidine|2 mc/kg/h over ten minutes followed by a continuous infusion of 2 mcg/kg/h
16031965|NCT02652507|Drug|Ketamine|Bolus dose 2 mg/kg after first set of research images are obtained
16031966|NCT02652481|Device|ImageReady MR Conditional Defibrillation System|"ImageReady MR Conditional Defibrillation System Components:
~Device Name Device Model Number Pulse Generators Phase I and II Phase II Only * CRT-D (IS1/DF4/IS4) VR ICD (DF4) DR ( dual chamber) ICD (IS1/DF4) ORIGEN™ MINI ICD ORIGEN EL ICD ORIGEN X4 CRT INOGEN™ MINI ICD INOGEN EL ICD INOGEN X4 CRT DYNAGEN™ MINI ICD DYNAGEN EL ICD DYNAGEN X4 CRT-D AUTOGEN ™ MINI ICD* AUTOGEN EL ICD* AUTOGEN X4 CRT-D* Right Atrial Leads and Accessories FINELINE™ II Sterox FINELINE II Sterox EZ Suture Sleeves for FINELINE II Leads INGEVITY™ MRI* Suture Sleeve for INGEVITY MRI* IS-1 Lead Port Plug 7145 Right Ventricular Leads and Accessories RELIANCE 4-FRONT™ (DF4)* Suture Sleeve for RELIANCE 4-FRONT leads*; ENDOTAK RELIANCE™ (DF4) Left Ventricular Leads and Accessories ACUITY™ X4 (IS4) Suture Sleeve for ACUITY X4 leads
~* May only be used internationally outside the US"
16031967|NCT02652468|Drug|Fludarabine Phosphate|Fludarabine will be administered by IV over approximately 30 minutes for 4 days.
16031968|NCT02652468|Drug|Mesna|Given IV over 24 hours starting prior to cyclophosphamide
16031969|NCT02652468|Drug|Cyclophosphamide|Given IV for 2 days
16031970|NCT02652468|Radiation|Total nodal irradiation|Undergo total lymphoid irradiation
16031971|NCT02652468|Biological|T Cell-Depleted Hematopoietic Stem Cell Transplantation|Undergo TCR alpha-beta/DC19-depleted hematopoietic stem cell transplant
16031972|NCT02652468|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo TCR alpha-beta/DC19-depleted hematopoietic stem cell transplant
16031973|NCT02652468|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo TCR alpha-beta/CD19-depleted hematopoietic stem cell transplant
16031974|NCT02652468|Drug|Mycophenolate Mofetil|Given PO
16031975|NCT02652468|Drug|Tacrolimus|Given PO or IV ONLY if graft cell content is over 1 x 10^5 cells/kg ideal BW of the patient
16031976|NCT02652468|Biological|Rituximab|Given IV ONLY if graft B cell content exceeds 1 x 10^5 cells/kg ideal BW of the patient
16031977|NCT02652455|Drug|Nivolumab|Participants entering the study after the first 6 participants only: Treatment with nivolumab prior to removal of tumor sample for TIL growth. About 2 weeks after their tumor sample has been taken, these participants may receive additional infusions of nivolumab.
16031978|NCT02652455|Procedure|Surgery to Remove Tumor for Growth of TIL|All participants: Tumor sample taken for growth of TILs. Growing the TILs takes about 4-8 weeks.
16031979|NCT02652455|Drug|CD137|All participants: Anti-CD137 agonistic antibody as an agent to augment T cell proliferation in vitro. The growth of the TIL will be accelerated by the use of CD137 activating antibody in the laboratory.
16031980|NCT02652455|Drug|Cyclophosphamide|All participants: Lymphodepleting chemotherapy intravenously, beginning 3 to 6 weeks after tumor collection for TIL growth.
16031981|NCT02652455|Drug|Fludarabine|All participants: Lymphodepleting chemotherapy intravenously, beginning after first 2 days of cyclophosphamide.
16031982|NCT02652455|Biological|TIL Infusion|After completing one week of lymphodepleting chemotherapy, all participants will be admitted back into the hospital for IV infusion of the TIL cells.
16031983|NCT02652455|Drug|Interleukin-2|After TIL infusion, in-patient high dose IL-2 treatment.
16031984|NCT02652442|Behavioral|Centrifugation|Participants will be rotated in a darkened rotary chair booth with 1 ear positioned 7-8 cm off-axis and the other ear positioned on-axis. Following a 5-minute rest period, the procedure will be repeated with the opposite ear positioned off-axis. Participants will receive 10 sessions in a 4-week period.
16031985|NCT02652429|Drug|Inhaled Nitric Oxide|
16031986|NCT02652416|Drug|BI 1026706|oral administration
16031987|NCT02652416|Drug|Placebo|placebo
16031988|NCT02652403|Device|Complete conventional dentures|"The typical operations of conventional technique will be carried out dentures fabrication and clinical appointments and laboratory steps will be necessary until denture insertion:
~Preliminary impression using irreversible hydrocolloid in a stock trays; Individual acrylic resin trays fabrication; Functional impressions using Zinc oxide-eugenol paste and low fusion compound in a individual acrylic resin trays; Maxillary occlusion rims fabrication; Maxillary occlusion rims fabrication adjustments, Centric relation records and transference of the maxillary occlusion rims positions to semiadjustable articulators using a facebow; Setting of teeth in wax; Complete denture wax try-in; Insertion, instructions and postinsertion appointments."
16031989|NCT02652403|Device|Complete simplified dentures|For a complete simplified denture fabrication, individual acrylic resin trays fabrication and functional impressions steps will be deleted, and the facebow for transference of the maxillary occlusion rims positions to semiadjustable articulators will be replaced by the table Camper.
16031990|NCT02652390|Drug|Methylprednisolone 80 mg|2 mL methylprednisolone (40 mg/mL) + 1 mL lidocaine
16031991|NCT02652390|Drug|Methylprednisolone 40 mg|1 mL methylprednisolone (40 mg/mL) + 1 mL saline + 1 mL lidocaine
16031992|NCT02652390|Other|Saline|2 mL saline + 1 mL lidocaine
16031993|NCT02652377|Drug|EDP-494|10, 100 and 200 mg capsules
16031994|NCT02652377|Drug|Placebo|placebo to match EDP-494
16031995|NCT02652351|Biological|Human umbilical cord mesenchymal stem cells|A single dose of 2×107 hUC-MSC will be implanted to patients by intravenous infusion or Hepatic artery intervention, and repeated every week for four times.
16031996|NCT02652338|Dietary Supplement|MNC-01|twice daily 2 tablets with appr. 200 ml still water or tap water; duration: 6 weeks
16031997|NCT02652338|Dietary Supplement|Placebo|twice daily 2 tablets with appr. 200 ml still water or tap water; duration: 6 weeks
16031998|NCT02652325|Drug|Saline|
16031999|NCT02652325|Drug|Povidone-Iodine|
16032000|NCT02652325|Drug|5% Povidone-Iodine USP swabs|
16032001|NCT02652312|Drug|Dexmedetomidine|A maintenance dose of Dexmedetomidine infusion at 0.5 mcg/kg/hour made to 20 mL with normal saline will be administered
16032002|NCT02652312|Drug|Placebo|A maintenance dose of 20 mL with normal saline will be administered at a rate similar to that of dexmedetomidine
16032003|NCT02652312|Procedure|Ondansetron|0.15 mg/kg intravenous (IV) will be given as a pre-medication
16032004|NCT02652312|Procedure|fentanyl|1.5 μg/kg intraoperative
16032005|NCT02652312|Procedure|propofol|10 mg every 5 seconds until the BIS level dropped below 60 for induction of anesthesia
16032006|NCT02652312|Procedure|Atracurium|0.5 mg/kg IV for endotracheal intubation
16032007|NCT02652312|Procedure|diclofenac sodium|1 mg/kg for postoperative analgesia
16032008|NCT02652312|Procedure|desflurane|1 MAC concentration (expired fraction of 6.0 vol%) for maintenance of anesthesia
16032009|NCT02652299|Biological|Synovial biopsy|Synovial tissue for analysis and biobank.
16032010|NCT02652286|Device|HARMONIC ACE+7|Pulmonary artery sealing with Harmonic Ace+7 in VATS lobectomy in humans
16032011|NCT02652273|Drug|Abatacept|Abatacept 125mg/ml
16032012|NCT02652260|Drug|Doravirine, Tenofovir, Lamivudine - Blinded|A single tablet FDC containing doravirine 100 mg, lamivudine (3TC) 300 mg and tenofovir disoproxil fumarate (TDF) 300 mg administered orally, once daily for 12 weeks during the Blinded period
16032013|NCT02652260|Drug|Doravirine, Tenofovir, Lamivudine - Open-Label|A single-tablet FDC containing doravirine 100 mg, 3TC 300 mg and TDF 300 mg administered orally, once daily for either 12 or 24 weeks during the Open-Label Period; also an additional 96 weeks during the Open-Label extension period 1; a maximum total duration of treatment of 228 weeks during the Open-Label extension period 2; and a maximum total duration of treatment of 324 weeks during the Open-Label extension period 3.
16032014|NCT02652260|Drug|ATRIPLA^TM|A single tablet FDC containing efavirenz (EFV) 600 mg, emtricitabine (FTC) 200 mg, and TDF 300 mg administered orally, once daily for 12 weeks during the Blinded period
16032015|NCT02652260|Drug|Placebo to ATRIPLA™|A single placebo to ATRIPLA™ tablet administered orally, once daily for 12 weeks during the Blinded period
16032016|NCT02652260|Drug|Placebo to Doravirine, Tenofovir, Lamivudine|A single placebo to doravirine, tenofovir, lamivudine tablet administered orally, once daily for 12 weeks during the Blinded period
16032017|NCT02652247|Procedure|molecular analysis of exhaled breath condensate|
16032018|NCT02652247|Procedure|molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate|
16032019|NCT02652247|Procedure|molecular analysis of bronchoalveolar lavage (BAL) aspirate|
16032020|NCT02652234|Drug|Endostar|Endostar, ih, QD，day 1 of cycle 1; Endostar, ih, QD，day 2-15 of cycle 3;
16032021|NCT02652234|Drug|Chemotherapy|
16032022|NCT02652221|Device|Acoustic Radiation Force Imaging|ARFI US is a novel technique, recently FDA approved for use in children and adults, which provides an alternative method for quantifying liver stiffness.
16032023|NCT02652208|Behavioral|Online decision aid|The Healthwise online shared decision point for Stable Chest Discomfort
16032024|NCT02652208|Behavioral|Video decision aid|The Health Dialog DVD and booklet decision aid for Stable Chest Discomfort
16032025|NCT02652195|Drug|Placebo|Placebo intranasal administration, 3 puffs per nostril, delivered prior to scanning session.
16032026|NCT02652195|Drug|Oxytocin|Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff, delivered prior to scanning session.
16032027|NCT02652169|Drug|PRF mixed with amikacin and teicoplanin|PRF, mixed with amikacin and teicoplanin is applied to the chronic ulcer
16032028|NCT02652169|Drug|PRF mixed with PHMB plus Macrogolol|PRF, mixed with Lavasorb is applied to the chronic ulcer
16032029|NCT02652169|Drug|PRF plus normal saline|PRF as a monosubstance plus sodium chloride 0.9% is applied to the chronic ulcer
16032030|NCT02652169|Other|Silver gauze|Acticoat 7 silver wound dressing is applied to the chronic ulcer
16032031|NCT02652156|Drug|Bupivacaine|60 ml Bupivacaine 0.25% will be drawn via 60 ml Syringe. The syringe will be connected and a 10ml flush syringe containing 10ml 0.9% Normal Saline (NS) will be connected to the end of an IV extension set via a 3-way stopcock and Luer lock connections. The Bupivacaine 0.25% syringe will be connected to the stopcock. The distal end of the IV connection will be connected to the injection needle. The entire setup will be flushed with 0.9% NS via flush syringe. The TAP space will also be located under ultrasound guidance and verified by using the 0.9% NS flush syringe. Once in the TAP space, 30 ml Bupivacaine 0.25% will be injected into the TAP space. This dose will be decreased to 25 ml for patients under 70 kg. The process will be repeated on the opposite side TAP block.
16032032|NCT02652156|Drug|Exparel®|20 ml Exparel (266 mg) will be drawn into a 20 ml syringe. A 20 ml Bupivacaine 0.25% syringe and the syringe containing the Exparel solution will be connected to the end of an IV extension set via a 3-way stopcock. The IV connection will be connected to the injection needle. The setup will be flushed with the Bupivacaine syringe. The TAP space will be located under ultrasound guidance. 133mg of Exparel will be injected into the TAP space. After injection, the syringe will be exchanged for the Bupivacaine syringe and 20ml Bupivacaine injected into the space. The process will be repeated on the opposite side TAP block.
16032033|NCT02652156|Drug|Ropivacaine|40 ml Bupivacaine 0.25% will be drawn via two 20ml Syringes. A Bupivacaine 20ml syringe will be connected to an IV extension via a 3-way stopcock and Luer lock. The IV will be connected to an injection tuohy needle and flushed with NS. The TAP space will be located using ultrasound guidance. 15 ml Bupivacaine 0.25% will be injected. A catheter will be threaded through the tuohy needle into the TAP space. 5ml Bupivacaine 0.25% will then be injected. The catheter will be secured via standard technique. The process will be repeated for the opposite side. Patients will receive a filled ON-Q system. The ON-Q system contains Ropivacaine 0.2%. The pump will run at 7 ml/hr. per side.
16032034|NCT02652143|Device|AneVivo (Medical device for in vivo culture of embryos)|
16032035|NCT02652143|Other|comparator for embryo culture in vitro|
16032036|NCT02652130|Biological|Remestemcel-L|No intervention given in GVHD002. It is a safety follow-up trial of Remestemcel-L treated subjects from GVHD001 trial
16032037|NCT02652091|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|Applied via the BETACONNECT device. Dose as prescribed by physician.
16032038|NCT02652091|Device|BETACONNECT device|Used to apply Betaseron.
16032039|NCT02652078|Device|Extracorporeal shockwave therapy|Ultrasonic shockwaves targeted at calf muscle bulk using the Piezowave 2 device (Richard Wolf, Knittlingen, Germany)
16032040|NCT02652065|Other|Acetylcholine iontophoresis|Acetylcholine will be locally delivered to patients by iontophoresis successively on healthy skin and on psoriasis plaque (order determined by randomization).
16032041|NCT02652065|Other|Sodium Nitroprussiate iontophoresis|Sodium Nitroprussiate will be locally delivered to patients by iontophoresis successively on healthy skin and on psoriasis plaque (order determined by randomization).
16032042|NCT02652065|Other|ppi water iontophoresis|ppi water will be locally delivered to patients by iontophoresis successively on healthy skin and on psoriasis plaque (order determined by randomization).
16032043|NCT02652065|Other|Laser Doppler recording|Skin blood flow will be recorded by laser Doppler during 2 minutes before iontophoresis, and during 30 minutes following iontophoretic delivery of vasodilators.
16032044|NCT02652052|Drug|Quercetin|Quercetin - take four 250mg capsules daily (total 1000 mg daily) for 3 consecutive days.
16032045|NCT02652052|Other|Standard of Care - Observation Only|Control Arm - Observation only
16032046|NCT02652052|Drug|Dasatinib|Dasatinib - take one 100 mg tablet by mouth once daily for 3 consecutive days
16032047|NCT02652039|Other|Questionnaires|Questionnaires
16032048|NCT02652026|Procedure|Nonsurgical periodontal treatment|Full mouth debridement, which consisted of scaling and root planing (SRP), was done in a single visit using an ultrasonic scaler (SATELEC P5 Newtron XS, Acteon, Merignac, France) and Gracey curretes (Hu- Friedy, Chicago, USA).
16032049|NCT02652026|Procedure|Dental Prophylaxis|Removal superficial plaque using an ultrasonic scaler (SATELEC P5 Newtron XS, Acteon, Merignac, France)
16032050|NCT02652013|Other|cognitive evaluation|
16032051|NCT02652000|Other|No intervention in this retrospective study|No Intervention in this retrospective Analysis.
16032052|NCT02651987|Drug|Lanreotide autogel 120 mg|
16032053|NCT02651974|Behavioral|Control condition|Patients will be mailed a control invitation letter to complete a home fecal immunochemical test (FIT) for colorectal cancer screening.
16032054|NCT02651974|Behavioral|Cost condition|Patients will be mailed a cost condition invitation letter to complete a home fecal immunochemical test (FIT) for colorectal cancer screening.
16032055|NCT02651974|Behavioral|Cost/Future condition|Patients will be mailed a cost/future condition invitation letter to complete a home fecal immunochemical test (FIT) for colorectal cancer screening.
16032056|NCT02651961|Procedure|Exchange of total hip or knee arthroplasty on same time|Removal of the index implants, extensive debridement, reimplantation of a new prosthesis
16032057|NCT02651961|Procedure|Exchange of total hip or knee arthroplasty in two time|Removal of the index implants in first time, extensive debridement, reimplantation of a new prosthesis in seconde time
16032058|NCT02651948|Procedure|Transperineal, MRI-guided, prostate biopsy|
16032059|NCT02651948|Procedure|Transrectal prostate biopsy (TRB):|
16032060|NCT02651935|Device|Intellivent ASV|Automated Invasive mechanical ventilation and weaning strategy
16032061|NCT02651909|Other|blood sampling|blood sampling for TEG analysis, Thrombin time, thrombin generation, PT with neoplastine, ecarin chromogenic assay, anti-factor Xa (rivaroxaban assay
16032062|NCT02651896|Radiation|HypoIGRT|"Hypofractionated intensity modulated and image guided radiotherapy 60 Gy in 20 fractions over four weeks for the prostate gland to all groups.
~For intermediate and high risk group: seminal vesicle will be included: 48 Gy in 20 fractions over 4 weeks (proximal third to half on physicians description).
~Image guidance with cone beam CT will be mandatory before every treatment fraction."
16032063|NCT02651883|Behavioral|Screening invitation (with education)|The participant will be provided with brief education about the importance and effectiveness of cervical cancer screening, and invited to schedule an appointment for a free in-clinic screening
16032064|NCT02651883|Behavioral|Self-collection for HPV testing|Participant is provided with a kit to take a self-collected sample at home and return it by mail for HPV testing. Results are provided to participant by phone.
16032065|NCT02651870|Drug|Candesartan 16mg|
16032066|NCT02651870|Drug|Amlodipine 5mg|
16032067|NCT02651870|Drug|Amlodipine 10mg|
16032068|NCT02651857|Device|Fuse® Colonoscope|Endoscopic diagnostic procedures for lower GI tract
16032069|NCT02651857|Device|Fuse® Gastroscope|Endoscopic diagnostic procedures for upper GI tract
16032070|NCT02651844|Drug|Mifepristone|"At the time a patient enters the protocol, 14 pills will be given to the personnel responsible of giving the patient the medicine at her home (This was a special requirement from the Argentine Authorities).
~Patients and personnel will sign the form each then she gets the medication and after that the signed form will be kept at the CRF file."
16032071|NCT02651831|Other|Focus groups and individual interviews|Focus groups conducted to explore general experiences, insights and concerns of those receiving ICM therapies. Individual semi-structured interviews to provide in-depth data on the themes identified in the focus groups.
16032072|NCT02651831|Other|Questionnaire|Health related quality of life questionnaire (FACT-ICM) to be completed by patients
16032073|NCT02651818|Procedure|Thyroidectomy|Regular thyroidectomy or hemithyroidectomy through Kocher's skin incision
16032074|NCT02651805|Device|Mechanical Insufflation-Exsufflation|Mechanical Insufflator-Exsufflator (MI-E): 6 assisted cough with expiratory pressure of -40cmH2O and inspiratory pressure defined by the therapist as the maximum pressure defined as comfortable; inspiratory time 3s and expiratory time 4s, using a manual cycle. Patients will be instructed to cough during exsufflation phase, with exception of Chronic obstructive pulmonary disease patients which will be instructed to exhale slowly. An oral-nasal mask will be used as interface, but in patients with tracheotomy, the device will be connected to it. A trained physiotherapist will conduct the therapy. During the night and weekends, patients will not start this therapy, however, if they have already started the therapy in MI-E group, or if they have already finished the period of follow-up they will be able to request this therapy, which will be provided by hospital staff . The equipment (Cough Assist®, Respironics, Phillips), will be available in the ward for the interventions.
16032146|NCT02651285|Other|G-CSF medium|incubation of IVF embryos with a specific medium containing G-CSF
16032075|NCT02651805|Other|Usual Care|The patients will receive the treatment according to the hospital protocol to deal with hypersecretive patients (suctioning that can be preceded by respiratory physiotherapy and nebulisation). A trained member of the nurse staff or a physiotherapist will be responsible for providing the therapy. A member of the research team will collect in the patients' records all the therapies provided by the staff to control hypersecretions.
16032076|NCT02651792|Drug|ketamine- propofol|1 mg x kg(-1) ketamine + 1.2 mg x kg(-1) propofol.
16032077|NCT02651792|Drug|pethidine- propofol|1.1 mg x kg(-1) pethidine + 1.2 mg x kg(-1) propofol for sedation induction
16032078|NCT02651779|Procedure|Open reduction and internal plate fixation|
16032079|NCT02651779|Other|Closed reduction and plasterimmobilisation|
16032080|NCT02651766|Procedure|Cupping massage|Using suction on the skin by means of glass cups, and moving the cups after applying massage oil on the skin
16032081|NCT02651753|Drug|Lipitor + Lipidil supra|Reference Drug: Lipitor + Lipidil supra
16032082|NCT02651753|Drug|CKD-337|Test Drug: CKD-337
16032083|NCT02651740|Drug|Rifaximin|400mg tid* 3d
16032084|NCT02651740|Procedure|Fecal microbiota transplantation|Using filtered fresh donor stool, 100-200ml per time throuth enteral nutrition tube for at least one time
16032085|NCT02651727|Drug|Part B, Cohort 1- VS-4718, nab-paclitaxel, gemcitabine|IV treatment in 28-day cycles (nab-paclitaxel 125 mg/m2 over 30 minutes on Days 1, 8, and 15 and gemcitabine at 1000 mg/m2 over 30 minutes on Days 1, 8, and 15) and oral VS 4718 BID continuously starting on Day 1 of Cycle 1
16032086|NCT02651727|Drug|Part B, Cohort 2- VS4718, nab-paclitaxel, gemcitabine|IV treatment for the first 2 cycles, followed by IV treatment and oral VS-4718 BID continuously starting on Day 1 of Cycle 3
16032087|NCT02651727|Drug|Part A- VS-4718, nab-paclitaxel, gemcitabine|Part A- intravenous (IV) treatment in 28-day cycles (nab-paclitaxel 125 mg/m2 over 30 minutes on Days 1, 8, and 15 and gemcitabine at 1000 mg/m2 over 30 minutes on Days 1, 8, and 15) and oral VS 4718 twice-daily (BID) continuously starting on Cycle 1 Day 2. The starting dose of VS-4718 will be 200 mg BID.
16032088|NCT02651714|Drug|Tradipitant|
16032089|NCT02651714|Drug|Placebo|
16032090|NCT02651701|Procedure|MR-PET|whole body MR-PET with dedicated liver+rectal protocol
16032091|NCT02651688|Drug|Placebo|One matching placebo capsule daily in the morning with approximately 8 ounces of water for up to 12 months.
16032092|NCT02651688|Drug|Enclomiphene|Enclomiphene capsule daily in the morning with approximately 8 ounces of water for up to 12 months.
16032093|NCT02651675|Biological|AAV directed hLDLR gene therapy|A novel adeno-associated viral (AAV) vector with human low-density lipoprotein receptor (hLDLR) gene
16032094|NCT02651662|Drug|cemiplimab|Multiple dose levels administered IV Q2W
16032095|NCT02651662|Drug|REGN1979|Single dose level of cemiplimab and multiple dose levels of REGN1979 administered IV
16032096|NCT02651649|Device|Continuous Positive Airway Pressure (CPAP)|FGR diagnosed parturients who are diagnosed with OSA will be prescribed CPAP as per standard of care.
16032097|NCT02651636|Drug|myo-inositol,alpha-lipoic acid and folic acid|
16032098|NCT02651623|Drug|Sertraline|Multiple doses of sertraline for 14 days
16032099|NCT02651623|Drug|Moxifloxacin|A single dose of 400 mg Moxifloxacin
16032100|NCT02651623|Drug|Drug - Placebo|Placebo administered for 14 days
16032101|NCT02651610|Biological|Bavituximab|Biological: bavituximab
16032102|NCT02651610|Drug|Taxane|Drug: Taxane Other names: Paclitaxel. Taxotere, Taxotere, Docecad, Taxol
16032103|NCT02651597|Other|Oatmeal|
16032104|NCT02651584|Drug|CAM2038 SC injection|
16032105|NCT02651584|Drug|SL BPN/NX tabs|
16032106|NCT02651584|Drug|placebo SC injections|
16032107|NCT02651584|Drug|SL placebo tablets|
16032108|NCT02651558|Device|Experimental: OBPM 2015-MD-0022 - CHEST|"At the onset of general anesthesia:
~continuous measurements of radial arterial blood pressure values (arterial catheter, via a commercial PHILIPS IntelliVue MP50 monitor)
~continuous estimates of optical blood pressure values at the chest (optical blood pressure system, via Swissmedic approved OBPM measuring device 2015-MD-0022 developed by CSEM)
~will be recorded."
16032109|NCT02651558|Device|Experimental: OBPM 2015-MD-0022 - CHEST & FINGER|"At the onset of general anesthesia:
~continuous measurements of radial arterial blood pressure values (arterial catheter, via a commercial PHILIPS IntelliVue MP50 monitor)
~continuous estimates of optical blood pressure values at the chest (optical blood pressure system, via Swissmedic approved OBPM measuring device 2015-MD-0022 developed by CSEM)
~continuous estimates of optical blood pressure values at the fingertip (optical blood pressure system, via Swissmedic approved OBPM measuring device 2015-MD-0022 developed by CSEM)
~will be recorded."
16032110|NCT02651558|Device|Experimental: OBPM 2015-MD-0022 - FINGER|"At the onset of general anesthesia:
~continuous measurements of radial arterial blood pressure values (arterial catheter, via a commercial PHILIPS IntelliVue MP50 monitor)
~continuous estimates of optical blood pressure values at the fingertip (optical blood pressure system, via Swissmedic approved OBPM measuring device 2015-MD-0022 developed by CSEM)
~will be recorded."
16032111|NCT02651532|Device|Confocal Laser Endomicroscopy|During colonoscopic withdrawal, the colonic mucosa will be observed with white light and be evaluated on the different segments of the colon with the confocal laser endomicroscopy technology in order to search for microscopic inflammation signs (altered crypt architecture, fluorescein leaks and dilated and prominent branching vessels)
16032112|NCT02651519|Drug|0.25% ropivacaine hydrochloride|stellate-ganglion block with 0.25% ropivacaine hydrochloride
16032113|NCT02651519|Drug|saline|stellate-ganglion block with saline
16032114|NCT02651506|Procedure|Electromagnetic Navigation Bronchoscopy|• Participants randomized to the intervention arm will undergo biopsy using the superDimension®InReach™ System. Participants will undergo ENB guided biopsy under general anesthesia or local anesthesia. The procedure will be performed by a thoracic surgeon in the operating room or endoscopy suite. Following electromagnetic mapping, bronchoscopy and biopsy will be performed. Fiducial markings will be placed when necessary.
16032147|NCT02651285|Other|Control|incubation of IVF embryos with a medium without G-CSF
16032148|NCT02651272|Drug|macitentan|10mg macitentan tablets
16032149|NCT02651259|Drug|Rifapentine (RPT)|900 mg of RPT
16032150|NCT02651259|Drug|Isoniazid (INH)|900 mg of INH
16032151|NCT02651259|Dietary Supplement|Pyridoxine (vitamin B6)|25 mg to 100 mg of pyridoxine, based on the current local, national, or international dosing guidelines.
16032115|NCT02651506|Procedure|Transthoracic Needle Biopsy|• Patients randomized to the control arm (TTNB) will undergo lung biopsy using standard transthoracic needle biopsy technique. The procedure will be performed under local anesthesia with computed tomography guidance by an interventional radiologist. In this procedure, a CT-image is used to locate the area for biopsy. Once identified, the radiologist applies a local anesthetic and inserts an aspiration needle between the ribs, through normal lung tissue, leading into the biopsy area. The sampled lung tissue is then sent for pathological analysis.
16032116|NCT02651493|Device|photographs|computer based program to analyze photographs (computer-aided diagnosis (CAD) software)
16032117|NCT02651480|Dietary Supplement|Plant-based diet|Weekly instructions will be given to the participants in the intervention group about following vegan diet.
16032118|NCT02651480|Dietary Supplement|Control Group|Unrestricted diet with no instruction.
16032119|NCT02651467|Other|Experimental Oral Rinse 1 (1.5% w/w KOX, 0ppm F, pH 7.0)|1.5% w/w KOX, 0ppm F, pH 7.0
16032120|NCT02651467|Other|Experimental Oral Rinse 2 (2.0% w/w KOX, 45ppm F, pH 4.5)|2.0% w/w KOX, 45ppm F, pH 4.5
16032121|NCT02651467|Other|Placebo Oral Rinse (0% w/w KOX 0ppm F, pH 4.5 )|0% w/w KOX 0ppm F, pH 4.5
16032122|NCT02651454|Drug|Daesiho-tang|Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
16032123|NCT02651454|Drug|Chowiseungcheng-tang|Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: Hanzung Pharmaceutical. co. Ltd.
16032124|NCT02651454|Drug|Placebo|Usage: 6g, three times a day, each taken before or between meals for 12 weeks Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
16032125|NCT02651441|Drug|Gemcitabine|Gemcitabine 1000mg/m2 IV on day1 and day8, repeat every 3 weeks.
16032126|NCT02651441|Drug|Cisplatin|Cisplatin 25mg/m2 IV on day 1,2 and 3, repeat every 3 weeks.
16032127|NCT02651441|Biological|D-CIK|8×10^9 D-CIK cells for each infusion, IV (in the vein) for 3 cycles, each cycle received four infusions on day 14, 16, 30 and 32.
16032128|NCT02651428|Drug|Neutrolin|Neutrolin® will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session
16032129|NCT02651428|Drug|Heparin|Heparin will be instilled into central venous HD catheters at the discontinuation of all dialysis sessions and will be withdrawn prior to the initiation of the next dialysis session
16032130|NCT02651415|Drug|Regorafenib|"Stivarga® will be used as per the marketed indication (on label), Coversyl will be used off-label and as such a Clinical Trial Application will be filed with Health Canada.
~Regorafenib will be administered 160 mg daily for 21 days of a 28 day cycle. Regorafenib will be administered with low fat breakfast, one hour after perindopril. A low fat breakfast as defined by the Stivarga ® (regorafenib) Product Monograph is one that is <30% fat, ~300-550 calories."
16032131|NCT02651415|Drug|Perindopril|COVERSYL® (perindopril erbumine) 4 mg will be administered daily for 21 days of a 28 day cycle. Perindopril will be administered orally, first thing in the morning on an empty stomach.
16032132|NCT02651402|Behavioral|FRIENDS for Life|Friends for Life (FRIENDS): FRIENDS, a GCBT program, is an effective program for the prevention and treatment of anxiety disorders in children evidenced by a meta-analysis on school-based interventions for at-risk and clinically anxious youth. FRIENDS was developed based on the view that anxiety is a tripartite construct involving physiological, cognitive, and behavioral components. Core Intervention components: Experts in CBT for childhood anxiety disorders have identified 5 essential components: psychoeducation, somatic management skills training, cognitive restructuring, exposure methods, and contingency management. The FRIENDS protocol consists of 10 weekly sessions and two booster sessions. We included the booster sessions in the regular protocol for a total of 12 sessions.
16032133|NCT02651402|Behavioral|Adapted FRIENDS|Adapted Friends (aFRIENDS): We conducted planned adaptations to the FRIENDS protocol based on our collective experience with the protocol and qualitative data (focus group and interviews). We followed procedures developed by Lee and colleagues, including surveying service providers and trainers regarding the appropriateness of FRIENDS for the target population. Changes were made to the language (idioms, metaphors, words), cultural fit (cultural values), methods (session length, number of sessions), activities (in-session practices), which resulted in additions and substitutions in these areas while maintaining the 5 essential components of the treatment. aFRIENDS is a briefer (8-session) and more engaging and culturally-sensitive protocol than FRIENDS.
16032134|NCT02651402|Behavioral|Train-the-Trainer|Train the Trainer (TT): agency supervisors are trained to conduct effective supervision (one initial training and 2 booster sessions), and then go on to train intervention therapists.
16032135|NCT02651402|Behavioral|Train-the-Trainer Plus|Train the Trainer Plus (TT+): a modified train-the-trainer approach by which supervisors receive training plus extended on-going consultation on conducting effective supervision with intervention therapists.
16032136|NCT02651376|Combination Product|Conventional plus AAIT|Participants received conventional (anti-opportunistic infections and ART) treatment and taken i.v., at a roud (3 times) of 2-3*10E8 MNCs/kg body at baseline, week 1 and 2.
16032137|NCT02651350|Drug|Methylprednisolone|Participants will receive methylprednisolone,48mg/d for the 1st week,32mg/d for the 2nd week,24mg/d for the next two weeks, followed by 16mg/d for 32 weeks and reduction in doses of methylprednisolone by 4 mg per 4 weeks until drug withdrawal.Participants will also receive standard treatment including reduced glutathione, glycyrrhizin, ademetionine, alprostadil, or ursodeoxycholic acid (UDCA) in the first 12 weeks.The total treatment duration will be 48 weeks. Follow-up duration is 24 weeks.
16032138|NCT02651350|Drug|Standard Treatment|Participants will only receive standard treatment,namely,routine liver protection drugs including reduced glutathione, glycyrrhizin, ademetionine, alprostadil,or ursodeoxycholic acid (UDCA) from week 0 through week 12 study visit. Participants will then be followed until week 72.
16032139|NCT02651337|Device|Cerebrospinal Fluid (CSF) Drainage|Placement of Alivio in line flusher during CSF drainage
16032140|NCT02651324|Drug|Ketamine|
16032141|NCT02651324|Other|Placebo|
16032142|NCT02651311|Other|intermediate cervical plexus block|ultrasound guided intermediate cervical plexus block with 0.25% ropivacaine 0.2 ml/kg
16032143|NCT02651311|Drug|Fentanyl|fentanyl 0.5 µg/kg in postanesthetic care unit when more or equal to FLACC scale 4.
16032144|NCT02651311|Drug|Ibuprofen|ibuprofen in ward when more or equal to FLACC scale 4.
16032145|NCT02651298|Device|Fractional Co2-laser|laser treatment
16032153|NCT02651233|Other|ADRCs therapy|Patients are submitted to manual liposuction and extraction of ADRCS is done with closed system. All patients were candidates for subcutaneous transplantation of autologous cell enriched adipose tissue for different indications.
16032154|NCT02651220|Drug|Epiduo® Forte Gel|Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
16032155|NCT02651220|Drug|Adapalene and Benzoyl Peroxide Gel|Adapalene and Benzoyl Peroxide Gel, 0.3%/2.5% w/w
16032156|NCT02651220|Drug|placebo gel|vehicle used as placebo
16032157|NCT02651207|Other|Questionnaire based study looking at pain scores felt by patients either having a lidocaine injection or ethyl chloride spray prior to insertion of a contraceptive implant|
16032158|NCT02651194|Drug|ABT-493/ABT-530|Tablet; ABT-493 coformulated with ABT-530
16032159|NCT02651181|Device|HLCL- Hybrid Logic Closed Loop System|All subjects wearing the HLCL System and using it with the closed loop algorithm
16032160|NCT02651168|Biological|aflibercept|EYLEA (aflibercept, solution for intravitreal injection) is a recombinant fusion protein consisting of portions of human Vascular Endothelial Growth Factor (VEGF) receptor 1 and 2 extracellular domains fused to the Fc portion of human IgG1 and formulated as an iso-osmotic solution for intravitreal administration. Aflibercept is produced in Chinese hamster ovary (CHO) K1 cells by recombinant DNA technology.
16032161|NCT02651155|Drug|Lubiprostone|Lubiprostone capsules
16032162|NCT02651155|Drug|Placebo|Lubiprostone placebo-matching capsules
16032163|NCT02651142|Procedure|Patients receive SLNB|Patients receive sentinel lymph node biopsy
16032164|NCT02651129|Other|Noise measurement|We will be measuring noise levels in the operating room
16032165|NCT02651116|Drug|Dextromethorphan Hydrobromide|15 mg/ 10 mL: 10 mL of Dextromethorphan Hydrobromide
16032166|NCT02651116|Drug|Placebo|10 mL Placebo
16032167|NCT02651116|Device|Cough recording device|FDA approved device validated for use in adults and children
16032168|NCT02651103|Device|NIRS|Cerebral oxygenation monitor which is standard of care for this surgery.
16032169|NCT02651090|Drug|Sonazoid|Comparison of Sonazoid enhanced ultrasound to non enhanced CT
16032170|NCT02651064|Other|HIP|
16032171|NCT02651051|Dietary Supplement|Whey Protein|20 g whey protein isolate (Arla Foods Ingredients Group) added to breakfast meal
16032172|NCT02651051|Other|High Fat Breakfast Meal|A standardised high fat breakfast served to all participants. The macronutrient distribution of the breakfast is 12% protein, 3% carbohydrate, 85% fat (1771 kJ; 423 kcal total)
16032173|NCT02651038|Drug|Micafungin|Measurement of PK
16032174|NCT02651025|Other|Resistance Exercise Program|"During the first week of training will be conducted two sets of 10 repetitions, and from the second week of training until the twelfth will be performed three sets of 10 repetitions. The work rate will set to the tolerance of each patient as established by his/her inability to maintain Borg ratings for dyspnea and effort (10-point category-ratio Borg scale) scores between 4 and 6."
16032175|NCT02650999|Drug|Pembrolizumab|200mg intravenously (IV)
16032176|NCT02650986|Drug|Cyclophosphamide|Given IV
16032177|NCT02650986|Drug|Decitabine|Given IV
16032178|NCT02650986|Other|Laboratory Biomarker Analysis|Correlative studies
16032179|NCT02650986|Procedure|Leukapheresis|Undergo leukapheresis
16032180|NCT02650986|Biological|TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes|Given IV
16032181|NCT02650973|Drug|CHS-1701|
16032182|NCT02650973|Drug|Pegfilgrastim|
16032183|NCT02650947|Dietary Supplement|Sucralose|Consumption of capsules containing either 200 mg sucralose (equivalent to diet soda 3 cans) per day for four weeks
16032184|NCT02650947|Dietary Supplement|Placebo|Consumption of empty capsule everyday for 4 weeks
16032185|NCT02650934|Procedure|Percutanous coronary intervention|
16032186|NCT02650921|Device|Restylane Lyft with Lidocaine|An injectable gel of Hyaluronic Acid and Lidocaine
16032187|NCT02650895|Biological|CD24Fc|Recombinant fusion protein consisting of the extracellular domain of mature human CD24 linked to the human immunoglobulin G1 (IgG1) Fc domain
16032188|NCT02650895|Drug|Saline|0.9% sodium chloride
16032189|NCT02650882|Procedure|Device POWERbreathe|
16032190|NCT02650869|Dietary Supplement|Probiotics|probiotics at a dose of 3x109 CFU/day. (Cap TS6 probiotic + contain Bifidobacterium spp., Lactobacillus at 6x109 CFU = 6 billion CFU manufactured by TENSALL BIO-TECH CO.LTD.Taiwan, distributed by Century Health Care, Bangladesh)
16032191|NCT02650869|Dietary Supplement|Breast milk|Normal breast milk will be given as part of standard care
16032192|NCT02650856|Drug|Group 1 Tranexamic Acid|2 gr of tranexamic acid will be applied on the surgical site.
16032193|NCT02650856|Biological|Group 2 Platelet rich plasma|16ml of platelet rich plasma will be applied of the surgical site
16032194|NCT02650843|Other|DAT SPECT imaging|
16032195|NCT02650817|Drug|RAD1901|RAD1901, a novel selective ER degrader (SERD)
16032196|NCT02650804|Drug|BPM31510 Nanosuspension Injection|
16032197|NCT02650804|Drug|Gemcitabine|
16032198|NCT02650791|Drug|Tranexamic Acid|
16032199|NCT02650778|Procedure|Breast ultrasound|automated whole breast ultrasound
16032200|NCT02650765|Other|Indications for head CT imaging after acute head injury|Indications for head CT imaging after acute head injury as per the Scandinavian guidelines for initial management of minimal, mild and moderate head injuries in adults.
16032201|NCT02650752|Drug|Lapatinib in Tandem With Capecitabine|
16032202|NCT02650739|Procedure|Macular hole surgery|Vitrectomy with internal limiting membrane removal and gas tamponade
16032203|NCT02650726|Dietary Supplement|Anthocyanin|anthocyanin 320 mg daily for 24 weeks
16032204|NCT02650726|Other|Placebo|placebo 320mg daily for 24 weeks
16032205|NCT02650713|Drug|Atezolizumab|Atezolizumab will be administered at a fixed dose of 1200 milligrams (mg) by intravenous (IV) infusion.
16032206|NCT02650713|Drug|RO6958688|"RO6958688 is administered by IV infusion
~In Part IA: RO6958688 is administered weekly (QW) on days 1,8 and 15 of each 21-day cycle.
~In Part 1b: RO6958688 is administered weekly (QW) or every 3 weeks (Q3W). Cohort A: RO6958688 starting dose will be 100 mg either QW or Q3W.
~Step Up dose cohorts: RO6958688 starting dose will be 40mg and increase with each administration up to the MTD or 1200 mg whichever is lower."
16032570|NCT02648074|Procedure|Bronchial challenge with allergen|Bronchial challenge is performed with D. pteronyssinus allergen.
16032207|NCT02650700|Radiation|spleen radiation|In Experimental arm, combine spleen radiation with chemotherapy. In Chemotherapy alone arm, the subjects should also receive spleen radiation once there is a severe CIT (≧grade III) during chemotherapy after radomization.
16032208|NCT02650687|Procedure|Processed EEG|In the operating room. Processed EEG will be measured using the Bispectral Index (BIS) monitor which is standard of care.
16032209|NCT02650674|Other|Product A: NP-0148|Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
16032210|NCT02650674|Other|Glucose solution|Glucose solution providing 50 g of available carbohydrates in 250 ml of water. This will be performed 3 times
16032211|NCT02650674|Other|Product B: NP-0149|Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
16032212|NCT02650674|Other|Product C: NP-0150|Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
16032213|NCT02650674|Other|Product D: NP-0151|Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
16032214|NCT02650674|Other|Product E: NP-0152|Portions of cereal product calculated to provide 50 g of available carbohydrates will be served with 250 mL water.
16032215|NCT02650661|Behavioral|Online health management program|"Web-based health management program designed according to SMASH strategy, which includes (i) Assessment, (ii) Acceptance, (iii) Preparation for change, (iv) Commitment, (v) Planning, (vi) Promoting environment, (vii) Execution, (viii) Feedback and Maintenance, and (ix) Core perspectives, for 6 months.
~The program consists of four areas: self-assessment, self-planning, self-learning, and self-monitoring. The learning session includes SMASH strategies and 10 Rules for Highly Effective Health Behavior."
16032216|NCT02650661|Behavioral|Health coaching|Personalized tele-coaching for 6 months by health coaches who were trained by the Smart Management and Coaching for Health (SMACH) program
16032217|NCT02650661|Behavioral|Workshop|Total three sessions are to be held at 3-, 5-, and 7-month after the initiation of the enrollment. Each session includes 30-minute health education, 1-hour health management strategy workshop, and 30-minute team coaching.
16032218|NCT02650661|Behavioral|Standard health educational booklet|"Standard health educational booklets about 10 Rules for Highly Effective Health Behavior that are organized according to the Trans-theoretical Model (TTM).
~Booklets are provided at 0-, 2-, and 4-month after the enrollment."
16032219|NCT02650648|Drug|cyclophosphamide|chemotherapy with intravenous (IV) cyclophosphamide 50mg/kg/day (for patients with body weight<70kg) or 1500mg/m^2/day (for patients with body weight ≥70kg) for two days (days -6 and -5).
16032220|NCT02650648|Biological|NK cells|Day 0: NK cell infusion. NK cells are resuspended in Normasol at a concentration no less than 5 x 10^6cells/mL. The patient is pre-medicated as per standard cell product infusion. The cell product is infused through a central venous catheter. Patients will be evaluated clinically by vital signs pre- and approximately 30 minutes post infusion of NK cells and thereafter at approximately 1 hour intervals for 4 hours.
16032221|NCT02650648|Biological|hu3F8|On Days -1, +1, +5, +7 and +9 hu3F8 is administered at 1.68 mg/kg/day and infused over ~30-90 minutes
16032222|NCT02650648|Drug|rIL-2|On day 0, daily from +2 through +4, day +6, and day +8, rIL-2 is administered subcutaneously at 6 x 10^5 U/m^2/day.
16032223|NCT02650635|Drug|Cyclophosphamide|Given IV
16032224|NCT02650635|Other|Laboratory Biomarker Analysis|Correlative studies
16032225|NCT02650635|Biological|Pegfilgrastim|Given SC
16032226|NCT02650635|Other|Pharmacological Study|Correlative studies
16032227|NCT02650635|Drug|TLR8 Agonist VTX-2337|Given SC
16032228|NCT02650622|Procedure|Skin Biopsy|Skin biopsy will only be performed on the proband children in the cohort 3. A small piece of skin (less than 1/8'') will be removed using a local anesthetic cream and a punch, which will then be used for culture of skin cells and other laboratory tests on metabolic function.
16032229|NCT02650609|Drug|Methylprednisolone|
16032230|NCT02650609|Drug|Placebo|
16032231|NCT02650596|Drug|GLP-1|Liraglutide were taken daily for 3 months
16032232|NCT02650596|Drug|Placebo|Placebo were taken daily for 3 months
16032233|NCT02650583|Other|Educational Intervention|Receive Enhancing Connections Program
16032234|NCT02650583|Other|Questionnaire Administration|Ancillary studies
16032235|NCT02650557|Procedure|angiography|angiography or arteriography is a medical imaging technique used to visualize the inside, or lumen, of blood vessels and organs of the body, with particular interest in the arteries, veins, and the heart chambers. This is traditionally done by injecting a radio-opaque contrast agent into the blood vessel and imaging using X-ray based techniques such as fluoroscopy.
16032236|NCT02650544|Drug|Mirtazapine|Patients in mirtazapine arm will be orally administered mirtazapine as an anti-depression therapy; along with palliative chemotherapy.
16032237|NCT02650544|Drug|Placebo|Patients in placebo arm will be orally administered placebo; along with palliative chemotherapy.
16032238|NCT02650518|Other|Short-course Antibiotics|3 days of amoxicillin/clavulanate, ciprofloxacin, or cotrimoxazole.
16032239|NCT02650518|Device|Catheter Change|Urinary catheter change once randomization is complete.
16032240|NCT02650505|Drug|LEO 43204|
16032241|NCT02650505|Drug|LEO 43204 Vehicle|
16032242|NCT02650492|Device|Immunostimulating Interstitial Laser Thermotherapy|Immunostimulating Interstitial Laser Thermotherpy (imILT) is a specific form of thermotherapy, which, in addition to destroying tumor tissue, has been optimized to cause a tumor specific immunologic response.
16032243|NCT02650479|Drug|Exenatide|6 hour IV infusion (double infusion of 0.1250 mcg/kg/hour for 30 min followed by infusion rate (1X) of 0.0625 mcg/kg/hour for 5.5 hours).
16032244|NCT02650479|Drug|Placebo|6 hour IV infusion.
16032245|NCT02650479|Drug|Moxifloxacin|400 mg oral dose moxifloxacin within 1 min of start of infusion of exenatide
16032246|NCT02650479|Drug|Palonosetron|0.25 mg administered IV within 30 minutes prior to initiating the infusion of exenatide
16032384|NCT02649335|Drug|Propranolol|Propranolol will be started at a dose of 40 mg and will be titrated based on pulse rate with target of 55-60 beats per minute or 20-25% reduction in heart rate and maximum tolerated dose.If any patients develop intolerable side effects, they will be withdrawn from the study
16032418|NCT02649127|Behavioral|self-care|meeting with a nurse to review and discuss publically available written materials that outline approaches for dealing with posttraumatic stress symptoms
16032247|NCT02650466|Device|Nanopulse System|The Nanopulse System consists of an electrical pulse generator, a handpiece, and a detachable applicator tip at the end of the handpiece that interfaces with the treatment area on the skin. The detachable applicator tip delivers the pulses to the skin through five 3 mm long needle electrodes (27 gauge). The applied electric field, is limited to the space enclosed by the 4 outer electrodes in the applicator tip. An inert, water based gel is applied to the skin and the applicator tip before making contact between subject and applicator tip to ensure that there are no air gaps present between the electrodes through which electrical arcing could occur while pulses are being delivered to the subject. The Applicator Tips are designed for single patient use, and are sterilized prior to first use and between treatment sessions using a standard steam autoclave.
16032248|NCT02650453|Procedure|Deep venous reconstruction|PTA & stenting with/without endophlebectomy and/or arteriovenous fistula creation
16032249|NCT02650440|Procedure|Novel Protocol|All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Novel (discrete) robot-assisted LT-BWST used progressive decrease in speed. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject.
16032250|NCT02650440|Procedure|Standard Protocol|All subjects performed robot-assissted LT-BWST 5 times a week for 6 weeks (30 minutes of training and 15 minutes of setup). Standard (rhythmic) robot-assisted LT-BWST used progressively increased speed each week. Both groups started the robot-assisted LT-BWST at the same speed of 1.4km/h. The body weight support started approximately at 40% of body weight for both groups and rapidly decreased each week. The guidance force was also progressively decreased for both groups so that the exoskeleton provided the least possible assistance to the subject
16032251|NCT02650427|Drug|Sitagliptin|100mg or 200mg or 600mg, daily for 3 weeks ± 7 days
16032252|NCT02650414|Biological|CART22 cells transduced with a lentiviral vector to express anti-CD22 scFv TCRz:41BB|
16032253|NCT02650401|Drug|Entrectinib|TRKA/B/C, ROS1, and ALK inhibitor
16032254|NCT02650388|Behavioral|Cognitive fuction, quality of life|To test the above score in patients undergoing TAVI
16032255|NCT02650375|Drug|Metatinib Tromethamine|Patients receive Metatinib orally 200mg once daily (QD) or 100mg twice daily (BID) until disease progression or unacceptable toxicity occurred.
16032256|NCT02650362|Other|fMRI|
16032257|NCT02650349|Other|fMRI|
16032258|NCT02650336|Drug|contrast|a substance used to enhance the contrast of structures or fluids within the body in medical imaging. It is commonly used to enhance the visibility of blood vessels and the gastrointestinal tract
16032259|NCT02650310|Device|Thermostable device|Investigators place the catheter with the loaded embryos into a plastic device at 37ºC in order to maintain the temperature
16032260|NCT02650297|Other|combined decongestive therapy|Patients in the intervention group received treatment with combined decongestive therapy and pneumatic compression pump. Patients in the control group received no treatment for lymphedema but were placed on the waiting list for combined decongestive therapy and pneumatic compression pump as soon as possible after the 8 weeks follow-up period.
16032261|NCT02650297|Device|pneumatic compression pump|Intermittent pneumatic pump or pressure therapy is not as a part of CDT, but it can be used as an adjunct method. This device intermittently and according to a specific program is air filled and emptied. The device leads the lymphatic fluid from distal to the proximal part of extremities and then to the trunk
16032262|NCT02650284|Device|Stryker Triathlon Primary Total Knee System|Total Knee Replacement
16032263|NCT02650284|Device|Restoris MCK Multicompartmental Knee System|Bicompartmental Knee Replacement
16032264|NCT02650271|Drug|Entecavir|Patients will be received entecavir (10 mg/d) before liver resection.
16032265|NCT02650271|Drug|Tenofovir|Patients will be received tenofovir before liver resection.
16032266|NCT02650258|Behavioral|treadmill walking|all participants walking at increasing speeds on a treadmill
16032267|NCT02650245|Dietary Supplement|EAS Myoplex Protein Drink + 10gm lactulose|
16032268|NCT02650232|Device|SOMNOtouch device (Somnomedics)|In each arm, we will evaluate the capacity of SOMNOtouch to measure the baroreflex sensitivity compared to Finapre Nova (reference)
16032269|NCT02650232|Procedure|Orthostatic test|"For each arm we will proceed to an orthostatic test day one and day two with :
~10 minutes in supine position
~10 minutes in sitting position
~5 minutes in standing position
~5 minutes in supine position"
16032270|NCT02650232|Device|Finapres Nova device (FMS system)|
16032271|NCT02650219|Genetic|genetic analyses|
16032272|NCT02650206|Drug|Victoza (liraglutide) with dietician monitoring|Victoza (liraglutide), an FDA-approved medication, is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Subjects with this intervention will be followed by the MD and dietician throughout the study to monitor progress through 4 week period of weight maintenance and 8 week period of weight loss.
16032273|NCT02650206|Other|Placebo with dietician monitoring|Subjects will not receive the study drug, but will be followed by the MD and dietician throughout the study to monitor progress through 4 week period of weight maintenance and 8 week period of weight loss.
16032274|NCT02650193|Drug|HSP-130|Dosage will vary per each cohort: (Five independent cohorts) Cycle 0 Regimen A - 3 mg Cycle 0 Regimen B - 6 mg Cycles 1-4 Regimen B - 6 mg Cycles 1-4 Regimen A (Potential)- 3 mg Cycles 1-4 Regimen C (Conditional)- 12 mg
16032275|NCT02650180|Device|Soberlink Cellular Device|Alcohol Breath Analyzer
16032276|NCT02650167|Biological|Colostrum feeding|
16032277|NCT02650167|Biological|formula for preterm infants|
16032278|NCT02650141|Drug|ziyinxiehuo Granules|"Ziyinxiehuo granules Herbs (1 bag ): shengdi 5g, xuanshen 3g, zexie 3g, zhimu3g, huangpai 3g, zhiguiban 2g, maiya 6g,tiandong 3g, zhigancao 2g Therapeutic Principle: Nourishing Yin, removing Fire Usage: administered after dissolved, 3 times per day after breakfast and supper"
16032279|NCT02650141|Drug|zishenqinggan Granules|"Zishenqinggan granules Herbs (1 bag ): Shengdi 5g, baishao 3g, huangqin 3g, fuling 4g, danpi 3g, maiya 6g, shanzha 3g, zhebei 3g, zhigancao 2g Therapeutic Principle: replenishing Kidney, Clearing Liver Usage: administered after dissolved, 3 times per day after breakfast and supper"
16032419|NCT02649114|Behavioral|Cognitive-Behavioural Therapy|
16032654|NCT02647437|Drug|Levetiracetam|
16032280|NCT02650128|Device|Shockwave Coronary Rx Lithoplasty® System|The Shockwave Coronary Rx Lithoplasty® System is a proprietary balloon catheter system designed to deliver localized, lithotripsy-enhanced, balloon dilatation of calcified, stenotic, de novo coronary arteries. Energizing the lithotripsy electrodes will generate pulsatile mechanical energy within the target treatment site and will disrupt calcium within the lesion and allow subsequent dilatation of a coronary artery stenosis using low balloon pressure. The system consists of a rapid exchange balloon catheter with integrated, internal lithotripsy electrodes and a Shockwave generator.
16032281|NCT02650102|Drug|Risperidone|a kind of antipsychotics
16032282|NCT02650102|Drug|Olanzapine|a kind of antipsychotics
16032283|NCT02650102|Drug|Quetiapine|a kind of antipsychotics
16032284|NCT02650102|Drug|Aripiprazole|a kind of antipsychotics
16032285|NCT02650102|Drug|Ziprasidone|a kind of antipsychotics
16032286|NCT02650089|Other|Resistance Exercise Low intensity|The 40% one maximum repetition resistance exercise session lasted 40 minutes. Three circuits with 7 exercises, 16 repetitions were performed for each exercise, with an interval of 60 seconds between exercises and 120 seconds between circuits. The duration of repetition in the exercises was 3 seconds - 1 second in the concentric phase and 2 seconds in the eccentric phase of the movement.
16032287|NCT02650089|Other|Resistance Exercise High intensity|The 80% one maximum repetition resistance exercise session lasted 40 minutes. Three circuits with 7 exercises, 16 repetitions were performed for each exercise, with an interval of 60 seconds between exercises and 120 seconds between circuits. The duration of repetition in the exercises was 3 seconds - 1 second in the concentric phase and 2 seconds in the eccentric phase of the movement.
16032288|NCT02650089|Other|Control|In the control session, the participants remained seated in a comfortable chair in the same environment of the resistance exercise sessions.
16032289|NCT02650076|Drug|SK-1405|
16032290|NCT02650063|Drug|DE-117|
16032291|NCT02650050|Radiation|Micropulsed laser photocoagulation|Micropulsed laser photocoagulation after 3 anti-VEGF injections
16032292|NCT02650037|Procedure|Air Test|The Air Test simply consisted in breathing room air for 5 min on arrival into the postoperative anesthesia care unit while measuring peripheral oxygen saturation by Pulse oximetry
16032293|NCT02650011|Other|Acute deterioration of liver function|development of new ascites within 4 weeks or re-emergence of ascites who have previous well controlled ascites (greater than or equal to grade 2 or 3; International ascites club criteria) development of hepatic encephalopathy development of gastrointestinal hemorrhage development of jaundice (serum bilirubin greater than or equal to 3mg/dl) development of bacterial infection
16032294|NCT02649998|Drug|Furosemide|Furosemide is the most commonly used medication for treatment of heart failure. It causes a direct vasodilator effect shortly after administration, followed by diuresis induction. However, furosemide also activates both the sympathetic and the renin angiotensin systems, causing a rise in peripheral resistance.
16032295|NCT02649998|Drug|Isosorbide Dinitrate|Isosorbide dinitrate is a vasodilator which is also well-known for treating acute decompensated heart failure. It induces acute venodilatation at low dose and arteries dilation when gradually increasing the dose. The effect peaks 5 min after administration.
16032296|NCT02649985|Drug|[F-18]PBR06|PET radiopharmaceutical
16032297|NCT02649985|Drug|[C-11]PBR28|PET radiopharmaceutical
16032298|NCT02649972|Drug|Cobimetinib|Cobimetinib will be administered at a dose of 60mg daily for 21 days on, then 7 days off, in a 28 day treatment cycle. Patients will have the option to discontinue treatment after 12 cycles and will be monitored for disease relapse for an additional 12 months. In the event that disease relapse occurs within the 12 month monitoring period, patients will restart treatment and continue on study. Upon restarting, the assessment schedule will restart at rechallenge cycle 1(RC-1) and all assessments will occur at the frequency and intervals. Cycle 1 Day 15 visits will not be required for patients that restart treatment after relapse. Participants will re-sign consent upon rechallenging.
16032299|NCT02649959|Drug|CM-AT|Single unit does powder of active substance (CM-AT) administered 3 times per day
16032302|NCT02649933|Device|Watch PAT 200|screening of OSA with Watch PAT 200
16032303|NCT02649920|Device|Cervical ripening balloon|
16032304|NCT02649920|Drug|Dinoprostone|
16032305|NCT02649907|Dietary Supplement|nutritional stimulation via different testmeals|nutritional stimulation of hormonal response through different testmeals
16032306|NCT02649907|Other|Nutritional counseling|nutritional counseling for healthy eating behaviour
16032307|NCT02649907|Dietary Supplement|formula diet|formula diet to help weight loss
16032308|NCT02649894|Device|Active Comparator: Approved Uncoated PleurX Indwelling Pleural Catheter|
16032309|NCT02649894|Device|Experimental: Silver Nitrate Coated Indwelling Pleural Catheter (SNCIPC)|
16032310|NCT02649881|Procedure|The heart subject will undergo OCT|
16032311|NCT02649868|Procedure|TAE|Transarterial embolization
16032312|NCT02649868|Radiation|RFA|Thermal ablation
16032313|NCT02649868|Device|LC Bead LUMI|LC Bead LUMI has been designed as a radiopaque version of the LC Bead
16032314|NCT02649855|Biological|PROSTVAC-V|It is a recombinant vaccinia virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules (B7.1, ICAM-1, and LFA-3). It will be given subcutaneously, 2x10(8) infectious units.
16032315|NCT02649855|Biological|PROSTVAC-F|It is a recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules (B7.1, ICAM-1, and LFA-3). It will be given subcutaneously, 1x10(9) infectious units.
16032316|NCT02649855|Drug|Docetaxel|It is commercially available. It will be administered at 75 mg/m(2) intravenously.
16032317|NCT02649842|Device|TECNIS Toric Models ZCT450, ZCT525 or ZCT600|Approved toric intraocular lens
16032420|NCT02649114|Behavioral|Compassion-Focused Therapy|
16032421|NCT02649101|Drug|Thalidomide|Thalidomide tablet 100mg qn po.
16032422|NCT02649101|Drug|Physician's choice chemotherapy|Investigators will declare no constraint of regimens.
16032423|NCT02649088|Device|Microscan|It allows to look at sublingual microcirculation
16032318|NCT02649829|Biological|dendritic cell vaccination plus chemotherapy|"A. Chemoimmunotherapy:
~four 3-weekly cycles of platinum/pemetrexed; on day 1 of each cycle, pemetrexed 500 mg/m2 should be administered as intravenous (IV) infusion over 10 minutes followed 30 minutes later by cisplatin 75 mg/m2 as IV over approximately 2 hours.
~four intradermal vaccinations with 8-10 x 10e6 autologous WT1 mRNA-loaded DCs; at day 14+/- 3 days after the start of each chemotherapy cycle.
~B. Surgery: pleurectomy/decortication; in case of resectable disease, 4-6 weeks after start of the last chemotherapy cycle."
16032319|NCT02649803|Behavioral|asthma APP|Subjects diagnosed as pediatric asthma at Shanghai Children's Medical Center will be consecutively screened and eligible patients will be recruited (enrolment visit, V1). The subject will be assigned to the nearest community hospital or Shanghai Children's Medical Center, whichever is nearer to the subject's home, for their future onsite visits (V2-V5). The patient's caregiver will be instructed to install the asthma APP at their smart phone and learn how to use this APP.
16032323|NCT02649764|Drug|Cytarabine|Given IV
16032324|NCT02649764|Drug|Fludarabine Phosphate|Given IV
16032325|NCT02649764|Other|Laboratory Biomarker Analysis|Correlative studies
16032326|NCT02649764|Drug|Prexasertib|Given IV
16032327|NCT02649751|Drug|Roscovitine|Roscovitine is an experimental drug candidate in the family of pharmacological cyclin-dependent kinase (CDK) inhibitors that preferentially inhibit multiple enzyme targets including CDK2, CDK7 and CDK9. Seliciclib is a 2,6,9-substituted purine analog.
16032328|NCT02649751|Drug|Placebo|The placebo treatment is lactose capsule.
16032329|NCT02649738|Procedure|Corneal tissue inlay|A mid-stomal pocket will be made into the cornea with a femtosecond laser (Intralase). A small disc of preserved corneal tissue will then be placed into the pocket
16032330|NCT02649725|Behavioral|patient's satisfaction|Questionnaire based measurement.
16032331|NCT02649712|Device|biliary stent|Self-expandable biliary nitinol alloys stent
16032332|NCT02649699|Other|3D MRI Scans|Patients will receive additional MRI scans before commencing their radiation treatment, at 3-4 months, 6 months and 12 months post RT as well as at recurrence or suspected recurrence.
16032333|NCT02649686|Drug|Durvalumab|
16032334|NCT02649686|Drug|Trastuzumab|
16032335|NCT02649673|Drug|LCL161|
16032336|NCT02649673|Drug|Topotecan|Topotecan will also be administered orally. Patients in DL 1 will receive topotecan at 1.8 mg/m2 per day for the first 5 days of each 21-day cycle. Patients in DL 2 will receive topotecan at 2.3 mg/m2 per day for the first 5 days of each 21-day cycle. The maximum dose for topotecan will not exceed 2.3 mg/m2 per day in this study.
16032337|NCT02649673|Drug|Pegylated GCSF (PEG-GCSF)|Pegylated GCSF (PEG-GCSF) (e.g. pegfilgrastim) on-body injector (OBI) or daily GCSF (e.g. filgrastim) will be given according to institutional policy after Day 5 of topotecan. Because patients treated with topotecan are at high risk of developing febrile neutropenia, GCSF will be given in the prophylactic setting.
16032338|NCT02649647|Procedure|Conventional resection|The conventional technique requests an excision of at least 10 cm of bowel proximal to the tumor, and the sigmoid colon is anastomosed to the rectum or anus. A defunctioning ileostomy is routinely performed.
16032339|NCT02649647|Procedure|Proximally extended resection|The modified technique requests an excision of the whole sigmoid colon and rectum proximal to the tumor, and the descending colon is anastomosed to the rectum or anus. A defunctioning ileostomy is routinely performed.
16032340|NCT02649634|Behavioral|Motivational Interviewing|The semi-structured MI protocol was a 45-60 minute intervention based on general MI principles and guidelines, MI strategies specific to health care practice, and MI principles for obesity treatment. The MI protocol included the following components: (1) eliciting concerns about weight; (2) exploring ambivalence; (3) assessing importance and confidence for change; (4) writing a decisional balance; (5) bolstering self-efficacy; (6) looking towards the future; and (8) eliciting ideas for possible changes participant could make to work towards weight loss. Although there was slight variation, the protocol for both MI sessions consisted of similar components.
16032341|NCT02649634|Behavioral|Attention Control|The attention control interview was a semi-structured interview ascertaining information relevant to health history, weight history, diet history, dietary and physical activity habits. The majority of questions for the control interviews were drawn from the Behavioural Weight Loss Program intake application. It was designed to be structurally equivalent to the MI session in terms of length of session, timing of sessions, and treatment modality. The goal of the attention-control interview was to provide a pseudo-intervention that controlled for factors common to attending treatment (e.g., attending treatment sessions, having personal contact with a therapist, discussing weight-related issues).
16032342|NCT02649621|Biological|Amniotic Membrane Extract Eye Drop (AMEED)|Use of use Amniotic Membrane Extract Eye Drop (AMEED) on in vivo cultured limbal stem cells in the treatment of unilateral corneal stem cell damage.
16032343|NCT02649608|Drug|0.04 mg Lu AE04621|0.04 mg dose group
16032344|NCT02649608|Drug|0.08 mg Lu AE04621|0.08mg dose group
16032345|NCT02649608|Drug|0.2 mg Lu AE04621|0.2 mg dose group
16032346|NCT02649608|Drug|0.4 mg Lu AE04621|0.4 mg dose group
16032347|NCT02649608|Drug|0.6 mg Lu AE04621|0.6 mg dose group
16032348|NCT02649608|Drug|0.8 mg Lu AE04621|0.8 mg dose group
16032349|NCT02649608|Drug|1.0 mg Lu AE04621|1.0 mg dose group
16032350|NCT02649608|Drug|1.2 mg Lu AE04621|1.2 mg dose group
16032351|NCT02649595|Other|Red Cross Respite care|See detailed description.
16032385|NCT02649335|Procedure|Endoscopic variceal ligation (EVL)|Patients in EVL group will undergo regular sessions of UGIE with EVL till variceal eradication every 2- 4 weekly followed by 3 monthly for initial 6 months and 6 monthly in rest of the study period. If any patient develop acute variceal hemorrhage on follow up , will be treated inpatient with standard medical therapy(SMT) .
16032424|NCT02649088|Device|NIRS from Hutchinson|It allows to monitor tissue oxygen saturation
16032528|NCT02648386|Biological|NeuroRegen scaffold/BMMCs transplantation|Completely resected rectal tumor, exposed pelvic autonomic nerves, and then transplanted NeuroRegen scaffold loaded with 5 million bone marrow mononuclear cells to the nerve.
16032655|NCT02647437|Drug|Placebo|
16032352|NCT02649582|Biological|Dendritic cell vaccine plus temozolomide chemotherapy|"When eligible after total or subtotal resection (as assessed by neurosurgeon and post-operative brain MRI):
~Leukocyte apheresis (before chemoradiation): for DC vaccine production
~Chemoradiation (standard treatment: initiated as soon as the patient's hematological blood values are adequate after apheresis): 2 Gy once daily 5 days/week for 6 weeks with 75 mg/m² temozolomide daily from the first until the last day of radiotherapy (no longer than 49 days in total)
~Induction immunotherapy: intradermal vaccination with autologous WT1 mRNA-loaded DCs weekly (+/-1 day) for 3 weeks, starting ≥ 1 week after radiotherapy
~Chemo-immunotherapy: 150-200 mg/m²/d temozolomide days 1-5 every 28 days +/- 2 days (max. 12 months) starting ≥3 days after the third vaccine of the induction immunotherapy + DC vaccination on day 21±3 days of every 28-day cycle"
16032353|NCT02649569|Device|Monitoring Device|Wear activity monitor
16032354|NCT02649569|Other|Quality-of-Life Assessment|Complete the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30
16032355|NCT02649556|Other|THS 2.2|Ad libitum use of THS 2.2 in an ambulatory setting for 26 weeks.
16032356|NCT02649556|Other|CC|"Ad libitum use of CC in an ambulatory setting for 26 weeks.
~The subject's own preferred brands of CC (no brand restriction) continue to be used as the reference product."
16032357|NCT02649543|Procedure|Primary Closure|A double antibiotic scheme with a cephalosporin and metronidazole is used as prophylaxis, and the fascia was closed with a continuous Polyglycolic Acid 0 suture. Subcutaneous tissue was approximated with Polyglycolic Acid 3-0, and the skin is sutured using Polypropylene 2-0.
16032358|NCT02649543|Procedure|Vacuum Assisted Closure|A double antibiotic scheme with a cephalosporin and metronidazole is used as prophylaxis, and the fascia is closed with a continuous Polyglycolic Acid 0 suture. The VAC® system is then used, with change of dressings every 48 hrs. The wound is closed using Polypropylene 2-0 only after healthy granulation tissue and no signs of infection are present.
16032359|NCT02649543|Procedure|Delayed Primary Closure|A double antibiotic scheme with a cephalosporin and metronidazole is used as prophylaxis, and the fascia was closed with a continuous Polyglycolic Acid 0 suture. The wound is left open for at least 7 days, after which closure with Polypropylene 2-0 takes place if considered suitable by a board certified surgeon.
16032360|NCT02649530|Drug|WNT974|
16032361|NCT02649517|Procedure|Endomyocardial biopsy|Endomyocardial biopsy will be performed through a puncture in the femoral vein. 3-6 samples taken under the control of myocardial echocardiography or flyuroskopii. Samples of biopsy material then transmitted Pathomorphology for immunohistochemistry, light microscope.
16032362|NCT02649504|Drug|Rituximab|Rituximab will be given at the standard dose of 375mg/m2 on days 1, 8, 15, 22 of the study
16032363|NCT02649504|Drug|Dexamethasone|Dexamethasone will be given at dose 40 mg/day on days 1-4, 15-18, and 29-32 (+/- 3 days) of the study.
16032364|NCT02649504|Drug|Mycophenolate mofetil|Patients allocated to the active drug arm will be given Mycophenolate mofetil starting on day 33, 500 mg twice daily for the first week and then escalation to 1000 mg twice daily for 24 weeks.
16032365|NCT02649504|Drug|Placebo|Patients allocated to the placebo arm will be given placebo starting on day 33, 500 mg twice daily for the first week and then escalation to 1000 mg twice daily for 24 weeks.
16032366|NCT02649491|Other|Cohort Observation|Study participation will be offered to women, newly diagnosed with a gynecological malignancy who are due to be treated with pelvic radiotherapy.
16032367|NCT02649478|Drug|Fluticasone / Salmeterol|Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Vectura LOMI inhaler device
16032368|NCT02649478|Drug|Placebo|
16032369|NCT02649478|Drug|Advair Diskus 100/50|Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate administered via the Diskus inhaler device)
16032370|NCT02649465|Drug|Tofogliflozin|The group receiving Tofogliflozin (at a dose of 20mg once daily) for 48 weeks
16032371|NCT02649465|Drug|Glimepiride|Sulfonylurea dosage (Glimepiride): dosing from 0.5 mg for initial 4 weeks. Then, if there is no adverse effect or no improvement of glucose metabolism, glimepiride is escalated to 6 mg once daily.
16032372|NCT02649452|Other|vibration|vibration will be given using whole body vibration machine. The subject will place both palms on top of the vibration platform with their knee supported on the ground. They need to apply as much pressure on the vibration platform by using their body weight. The whole body vibration machine will be set at the frequency of 30 Hz and the amplitude of 5 mm. They need to hold that position for 1 minute for 3 sets with 1 minute rest in between. The researcher will immediately stop this if the subjects feel dizziness and discomfort
16032373|NCT02649439|Biological|PROSTVAC -V|Recombinant Vaccinia Virus Vector Vaccine of the Genus Orthopoxvirus
16032374|NCT02649439|Biological|PROSTVAC-F|Recombinant Fowlpox Virus Vector Vaccine of the Genus Avipoxvirus
16032375|NCT02649426|Device|The Paradise® Renal Denervation Ultrasound System|Randomization will occur following the diagnostic renal angiogram. Blinded patients randomized to treatment will receive the renal denervation procedure using the Paradise System to deliver ultrasound energy to thermally ablate and disrupt the renal sympathetic nerves while sparing the renal arterial wall.
16032376|NCT02649426|Device|Sham Procedure|Randomization will occur following the diagnostic renal angiogram. For blinded patients randomized to control, the diagnostic renal angiogram will be considered the sham procedure.
16032377|NCT02649413|Drug|Prednisone|Children with Idiopathic Nephrotic syndrome will start 60 mg/m2 prednisone.children that response in 8 days will receive an adjusted dose while the rest of the group will receive the 4 weeks usually dose.
16032378|NCT02649387|Drug|Ibrutinib|Given PO
16032379|NCT02649387|Other|Laboratory Biomarker Analysis|Correlative studies
16032380|NCT02649374|Behavioral|Dietary, Exercise and lifestyle modifications|Women without GDM will receive advise on diet, exercise and lifestyle modifications similar to what is advised to women with GDM
16032381|NCT02649361|Drug|Anlotinib|Anlotinib p.o. qd
16032382|NCT02649361|Drug|Placebo|Placebo p.o. qd
16032383|NCT02649348|Behavioral|pre-operative prehabilitation|To climb six flights of stairs (approximately 20 meters in height) at least 6 times as a daily routine and adaptive simulated training of restrictive ventilation dysfunction (increased thoracic and decreased abdominal breathing compliance) following abdominal surgery by using a full elastic breathable abdominal bandage.
16032567|NCT02648113|Biological|red blood transfusion|
16032568|NCT02648100|Other|biomarker study|
16032386|NCT02649322|Device|J-Tip|"After sterile preparation, the J-tip injector will be placed on the skin at the selected site of the regional block needle introduction. Firm pressure will be placed with the J-tip injector on the site for the chosen block, the safety ring slid down, the trigger pressed and the tip held firmly on the skin for three seconds. One quarter of a milliliter of one percent lidocaine will be injected with the characteristic pop and hissing sounds inherent to the J-tip injector."
16032387|NCT02649322|Device|Syringe and 25 gauge needle|The same initial timeout and sterile prep procedure will be followed for the use of local syringe and 25 gauge needle injection of 1% lidocaine ninety seconds prior to introduction of the regional block needle.
16032388|NCT02649309|Procedure|RIPre|Preconditioning 200 mmHg x 5 minutes before procedure
16032389|NCT02649309|Procedure|Sham-Pre|Sham 10 mmHg x 5 minutes before procedure
16032390|NCT02649309|Procedure|RIPost|Postconditioning 200 mmHg x 5 minutes after procedure
16032391|NCT02649309|Procedure|Sham-Post|Sham 10 mmHg x 5 minutes after procedure
16032392|NCT02649296|Other|Skanlab bodywave|The intervention will be done twice a week
16032393|NCT02649283|Device|OrbiSymm device|Breast symmetrisation following unilateral mastectomy and referred to contralateral symmetrisation procedure, with the OrbiSymm device, that requires reduction of at least 150grams.
16032394|NCT02649283|Procedure|Breast symmetrisation|Breast symmetrisation following unilateral mastectomy and referred to contralateral symmetrisation procedure, without the OrbiSymm System, that requires reduction of at least 150grams.
16032395|NCT02649270|Biological|T1h|Given T1h for different groups by vein to evaluate safety and tolerability;Collecting blood samples for pharmacokinetics and pharmacodynamics after administration.
16032396|NCT02649257|Procedure|cataract surgery|
16032397|NCT02649257|Device|intraocular lens (MC 6125 AS)|
16032398|NCT02649257|Device|capsular tension ring (CTR 13/11)|
16032399|NCT02649244|Behavioral|The Family Caregiver Training Program|The intervention consisted of a two-hour PowerPoint® presentation throughout three modules (i.e., communication, eating/feeding, and nutrition; transferring and toileting; and dressing, bathing, and grooming). Each module was followed by a hands-on demonstration and practice session, including how to properly position and feed an adult, transfer from a seated position to another seated position, and a case study on modifications and assistance to provide during dressing and grooming.
16032400|NCT02649231|Drug|Ketamine|0.8 mg/kg ketamine
16032401|NCT02649231|Drug|Placebo|0.9% saline
16032402|NCT02649231|Behavioral|Psychological Therapy|Manualised relapse prevention based CBT
16032403|NCT02649231|Behavioral|Alcohol Education|Simple education about alcohol effects
16032404|NCT02649218|Biological|Ligelizumab|QGE031 240 mg s.c. q4w
16032405|NCT02649205|Other|Observational study: Supplemented protein-restricted diet|Observational study: Supplemented protein-restricted diet
16032406|NCT02649192|Biological|Influenza virus vaccine|Children will have the first influenza virus vaccine dose (dose 1) administered on day 0 of the trial, and the second dose (dose 2) administered 28 days later.
16032407|NCT02649192|Dietary Supplement|Vitamins A and D|The chewable gummy contains either Vitamin A (20,000 International Units) and Vitamin D3 (2,000 International Units), which should be fully chewed under supervision of study staff with documentation in the participant's research record and eMAR (electronic medical administration record). The chewable gummy should be administered prior to receiving influenza virus vaccination.
16032408|NCT02649192|Other|Placebo|The chewable gummy matched placebo will be formulated with gelatin base and tangerine oil and match the Vitamin A and D in shape, taste, texture, and appearance. Gummies should be fully chewed under supervision of study staff with documentation in the participant's research record and eMAR (electronic medical administration record). The chewable gummy should be administered prior to receiving influenza virus vaccination.
16032409|NCT02649179|Drug|Ropivacaine|All wounds were infiltrated with 0.75% ropivacaine 14ml at port sites before wound closure(6ml for epigastric port ,6ml for umbilical port ,and 4ml for working port) . The study drugs will be applied to the skin, subcutis, fascia, and parietal peritoneum through the port sites at the end of surgery.
16032410|NCT02649179|Drug|0.9% saline|All wounds were infiltrated with 0.9% saline 14ml at port sites before wound closure(6ml for epigastric port ,6ml for umbilical port ,and 4ml for working port) . The study drugs will be applied to the skin, subcutis, fascia, and parietal peritoneum through the port sites at the end of surgery.
16032411|NCT02649166|Device|Deep brain stimulation|The deep brain stimulation system includes an implantable neurostimulator, thalamic leads to be implanted in the ventral intermediate nucleus (Vim), and subdural cortical strips. The deep brain stimulation system will be set to provide continuous stimulation for the 6 months following surgery. Subjects will be seen monthly for evaluation as a part of normal clinical care for deep brain stimulation. At 6 months, the investigators will determine whether or not the subject is a candidate for closed-loop deep brain stimulation. Qualifying subjects will have the option to have their settings changed in order to participate in the RBS stimulation intervention. These subjects will been seen every 6 months for evaluation as part of normal clinical care for deep brain stimulation.
16032412|NCT02649166|Device|Closed-loop deep brain stimulation|The deep brain stimulation system includes an implantable neurostimulator, Vim thalamic leads, and subdural strips. Six months post-surgery, the deep brain stimulation system will be set to provide responsive stimulation for the duration of the study. Subjects will be seen every 6 months for evaluation as a part of normal clinical care for deep brain stimulation. Data gathered from the subject during the first 6 months will be used to determine if this intervention is applicable for each individual subject. Subjects who do not qualify will continue to receive the other study intervention.
16032413|NCT02649153|Drug|smoked plum|Patients will receive smoked plum (3 piece each time, three times per day) starting in the first day after resection until flatus
16032414|NCT02649153|Drug|gum chewing|Patients will receive gum chewing (three times per day) in the first day after resection until flatus.
16032415|NCT02649140|Dietary Supplement|Vinegar group|Each participant in vinegar group drink 15ml vinegar(Ninghuafu,Sanxi,China)after dinner at noon and evening respectively for a period of four weeks.
16032416|NCT02649127|Behavioral|imaginal therapy|imaginal exercise of Prolonged Exposure therapy
16032417|NCT02649127|Behavioral|exercise|aerobic training at a frequency of a minimum of 3 sessions per week, at vigorous intensity [i. e., >60% of oxygen uptake reserve (VO2R)], and a time of 20-25 minutes each bout of training
16032425|NCT02649075|Other|Serum-derived Bovine Immunoglobulin / Protein Isolate|Serum-derived bovine immunoglobulin protein isolate (SBI) is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients. Two packets (each packet contains 5 g of SBI) BID.
16032426|NCT02649075|Other|Placebo|Matching placebo with control hydrolyzed gelatin protein. Two packets BID.
16032427|NCT02649062|Biological|NGM282|
16032428|NCT02649062|Other|Placebo|
16032429|NCT02649049|Other|there is no intervention|
16032430|NCT02649010|Device|Enlite 3 Sensor|Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the arm and used with the 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least 12 months.
16032431|NCT02648997|Drug|Nivolumab - 240 mg|240 mg every 2 weeks
16032432|NCT02648997|Drug|Ipilimumab - 1 mg/kg|1 mg/kg every 3 weeks
16032433|NCT02648997|Drug|Nivolumab - 480 mg|480 mg once every 4 weeks
16032434|NCT02648997|Drug|Nivolumab - 3 mg/kg|3 mg/kg every 3 weeks
16032435|NCT02648997|Radiation|External Beam RT|IMRT, 3D-CRT, or proton-beam radiation therapy
16032436|NCT02648984|Other|The intervention is performing an exercise test|Patients and controls will undergo a bicycle stress echocardiography and a cardiopulmonary exercise test
16032437|NCT02648971|Procedure|Single Portal Knee Arthroscopy|Patients in Group 1 will undergo knee arthroscopy using a single portal.
16032438|NCT02648971|Procedure|Two Portal Knee Arthroscopy|Patients in Group 2 will undergo knee arthroscopy using two portals.
16032439|NCT02648958|Drug|Dexmedetomidine|The dexmedetomidine group received the dexmedetomidine infusion at a rate of 0.4mg/kg/h after a loading dose of 0.5mg/kg for 10 minutes.
16032440|NCT02648958|Drug|normal saline|The control group received the normal saline infusion
16032441|NCT02648945|Other|Exercise|first, Verbal Memory task was completed by each participant. Participant then started walking on the treadmill at either a speed of 3.0 mph (4.8 km/h) for sedentary individuals or 3.5 mph (5.6 km/h) for active individuals with grade 0% (Hanson, 1984). This was followed by an increase in grade of 2% for every 2 mins with the speed remaining constant until targeted HR was reached. A heart rate (HR) monitor (POLAR®) was used to measure HR throughout the test and rating of perceived exertion (RPE) was done at the end of every 2 min stage. Exercise was stopped as soon as participant reaches targeted HR or requests to stop because of fatigue or any discomfort. Participant was then given time to cool down until HR reached or fell below 120 bpm and was allowed to take a break for approximately 1 min before proceeding with the second set of Verbal Memory Task. Upon completing the memory test, the participant was allowed to leave
16032442|NCT02648932|Biological|Haplo-Cord Transplant|For conditioning regimens, haplo-identical grafts will be selected by the Miltenyi Device
16032443|NCT02648932|Procedure|Matched Unrelated Donor Transplant|
16032444|NCT02648919|Drug|Noni extract|Intervention will be administered on an outpatient basis.Six bottles containing 60 capsules will be dispensed to all participants upon enrollment. Then 12 bottles (at 30-day visit) and 18 bottles (at 3, 6 and 9 month visits) will be dispensed to all participants.
16032445|NCT02648906|Drug|Choline alfoscerate|
16032446|NCT02648906|Drug|Placebo|
16032447|NCT02648893|Other|Multiple biofortified food crops (MBFC-Exp)|Meals from three biofortified food crops will be consumed by children (and potentially their lactating mothers) three times per day, six days per week, for 9 months.
16032448|NCT02648893|Other|Commercially available non-fortified food crops (MBFC-C)|This arm will consume meals based on three commercially available (non-biofortified) food crops three times per day, six days per week, for 9 months.
16032449|NCT02648880|Behavioral|Exercise program|"Individual exercise sessions in this program implement a whole body approach and consist of a 10-min cardiovascular warm-up and 50 minutes of cardiovascular endurance, resistance, and flexibility exercises. Target intensity of exercise will be based on the American College of Sports Medicine recommendations for cancer survivors. Prior to the start of exercise sessions, participants will be questioned on significant changes in symptoms or the presence of new symptoms (such as nausea or fever), which will used to modify the exercise session for that day to allow maximum symptom-limited participation."
16032450|NCT02648880|Other|Standard Care|The services that participants receive as standard care include their medical care, symptom control, social worker support, and nutrition. These services are provided by their oncology team.
16032451|NCT02648867|Device|Continuous Maternal Feedback|The PushCoach device consists of a modification of the standard fetal scalp electrode and a separate apparatus designed to detect movement of the fetal head by detecting movement of an FSE. The PushCoach will be attached to the patient by an adhesive pad over the sacrum and extend between the patient's legs approximately 2-3 inches from the vaginal introitus. It assesses the movement of the FSE attached to the fetal scalp during pushing. The amount of fetal movement will be measured and recorded. The PushCoach device is connected to a laptop computer which will provide optical and auditory feedback to the patient about descent of the fetal head with maternal expulsive efforts.
16032452|NCT02648854|Drug|CKD-395 0.5(Lobeglitazone)/1000(Metformin)mg 1T|administered CKD-395 0.5/1000mg 1T to oral (fasting condition)
16032453|NCT02648854|Drug|CKD-395 0.5(Lobeglitazone)/1000(Metformin)mg 1T|administered CKD-395 0.5/1000mg 1T to oral (High fat meal fed condition)
16032454|NCT02648841|Radiation|Adjuvant Concurrent Chemo-radiotherapy|Adjuvant concurrent chemo-radiotherapy will be given to the patients in the Experimental group after 4-6 cycles of SOX chemotherapy. Total dose of 45Gy is delivered by IMRT Radiotherapy technique. The concurrent chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral.
16032455|NCT02648841|Drug|Adjuvant chemotherapy for active comparator group|8 cycles of SOX adjuvant chemotherapy will be given to the patients in the active comparator group. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d.
16032456|NCT02648841|Drug|Adjuvant chemotherapy for experimental group|6 cycles of SOX adjuvant chemotherapy will be given to the patients in the experimental group. The SOX chemotherapy regimen is as follow: S-1 40-60mg Bid, Oral, D1-14, Q21D; Oxaliplatin 130mg/m2, ivgtt, D1, Q21d.
16032457|NCT02648828|Other|Clinical deterioration|Patients at risk of clinical deterioration
16032656|NCT02647424|Drug|Letrozole|Letrozole 2.5 mg daily from Day 2 to 6
16032458|NCT02648815|Procedure|Percutaneous catheter drainage|Depending on the operator experience, tandem trocar technique or Seldinger technique can be used. If the Seldinger technique is used, then the catheter tract should be sequentially dilated over a guidewire. Access routes that avoid crossing the bowel and other intervening organs, or major mesenteric, peripancreatic, or retroperitoneal blood vessels are selected to minimize the risk of bacterial contamination and hemorrhage. Successful percutaneous treatment of necrotic collections of the pancreas depends on several important factors. Catheters often need to remain in place for several weeks and sometimes months; hence, close follow-up is required.
16032459|NCT02648815|Procedure|Abdominal paracentesis evacuation|Evacuation of peritoneal ascitic fluid using percutaneous catheters
16032460|NCT02648802|Procedure|Cavity shaving|Resect the residual cavity circumferentially (superior, inferior, medial, lateral) and the thickness of the cavity shaving depends on the surgeon's discretion (Recommended 0.5-1.0cm). The principles of the cavity shaving includes: 1) do not compromise the cosmetic outcomes; 2) covers the entire cavity;
16032461|NCT02648802|Procedure|Standardized BCS+CM assessment.|For standardized BCS(Chen K, et al. Ann Surg Oncol. 2012), we resect a rim of 1 cm macroscopically normal tissue around the tumor. The anterior and posterior margins of the tumor-containing specimen extended up to the subdermal plane of the skin and down to the pectoralis major fascia, respectively. The anterior and posterior CMs assessment will not be needed. A surgical blade was used for resecting the CMs (superior, inferior, medial and lateral) to render the thickness of the CMs as thin as possible. No procedures were required for distinguishing the inner and outer surface. They were then frozen and cut parallel, but not perpendicular to the largest surface area. CMs were defined as positive when in situ or invasive carcinoma was found intraoperatively by frozen-section analysis.
16032462|NCT02648776|Drug|Exposure to sedative-hypnotic drugs|These patients will have been prescribed a sedative-hypnotic drug for at least one week prior to enrollment.
16032463|NCT02648750|Behavioral|Bridges self-management programme|The Bridges self-management programme is based on self-efficacy principles. It includes a Bridges stroke workbook consisting of stroke survivors' experiences and strategies, with space to record and reflect on personal goals and achievements, which the practitioner will work through with the participant. The practitioner will also used strategies based on key principles of self-management during interactions with patients.
16032464|NCT02648737|Behavioral|Cognitive Behavioural Therapy (CBT)|Cognitive Behavioural Therapy (CBT) is considered the gold standard in psychotherapeutic treatments of anxiety. CBT is defined as: 'An amalgam of behavioural and cognitive problem-based interventions guided by principles of applied science. The behavioural interventions aim to decrease maladaptive behaviours and increase adaptive ones by modifying their antecedents and consequences and by behavioural practices that result in new learning. The cognitive interventions aim to modify maladaptive cognitions, self-statements, or beliefs.' (Arch & Craske, 2009; Craske, 2010).
16032465|NCT02648737|Other|Clinical monitoring|Patients assigned to clinical monitoring only will receive general education material on coping with PD symptoms and behavioural symptoms such as anxiety. In addition, they will be followed-up 1 month after baseline assessment via telephone calls to inquire about current anxiety symptoms. Patients will remain under the care of their personal physicians, who will also monitor their medical and psychiatric status.
16032466|NCT02648724|Drug|Sym015|Sym015 is a mixture of two monoclonal antibodies which specifically bind to non-overlapping epitopes in the extracellular domain of MET.
16032467|NCT02648711|Drug|CRLX101|infusion CRLX101 weekly
16032468|NCT02648711|Drug|Bevacizumab|infusion weekly CRLX101 + bevacizumab biweekly
16032469|NCT02648711|Drug|mFOLFOX6|infusion weekly CRLX101 for 3 or every 4 weeks and in combination with bi-weekly mFOLFOX6
16032470|NCT02648698|Drug|Antibiotics|Levofloxacin Tab and Tinidazole Tab are combined in the antibiotic group
16032471|NCT02648672|Drug|BPN14770|BPN14770 is an investigational new drug being developed for the treatment of Alzheimer's disease and other cognitive disorders. BPN14770 is a small molecule, subtype selective, negative allosteric modulator of phosphodiesterase 4D.
16032472|NCT02648672|Drug|Placebo|
16032473|NCT02648659|Drug|Ilaprazole|Ilaprazole 10mg 1tablet qid(4 times/day)
16032474|NCT02648659|Drug|Amoxicillin|Amoxicillin 500mg 1capsule qid(4times/day)
16032475|NCT02648659|Drug|Clarithromycin|Clarithromycin 500mg 1tablet bid(2times/day)
16032476|NCT02648659|Drug|Metronidazole|Metronidazole 250mg 2tablets tid(3times/day)
16032477|NCT02648646|Other|Otago Exercise Programme and Walk with Ease|The Otago Exercise Programme is a falls prevention program that is successful at reducing falls in adults 65+ years of age. Briefly, this program includes flexibility, progressive lower extremity strengthening with ankle weights, and balance exercises. The investigators are replacing the Otago walking program with the evidence-based Arthritis Foundation's Walk With Ease program.
16032478|NCT02648633|Radiation|Stereotactic Radiosurgery|Subjects will receive a single large dose of radiation to one or more lesions.
16032479|NCT02648633|Drug|Nivolumab|3 mg/kg of nivolumab will be administered through IV infusion every two weeks following stereotactic radiosurgery.
16032480|NCT02648633|Drug|Valproate|Subjects will begin regimen of valproate prior to radiosurgery and continue to receive therapy concurrently with nivolumab. Subjects will receive valproate daily with a target serum level of 75-100 μg/ml.
16032481|NCT02648620|Device|SurVeil Drug Coated Balloon|Angioplasty procedure with the SurModics SurVeil Paclitaxel-Coated, Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (Paclitaxel-coated PTA Catheter)
16032482|NCT02648620|Procedure|Angioplasty|Angioplasty procedure with the SurModics SurVeil Paclitaxel-Coated, Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (Paclitaxel-coated PTA Catheter)
16032483|NCT02648607|Device|Customised Dynamic Elastomeric Fabric Orthosis (DEFO)|Eligible participants will be measured and fitted with a customised Dynamic Elastomeric Fabric Orthosis (DEFO). Participants will also be issued with standardised advice on PGP management via an information leaflet from Association of Chartered Physiotherapists in Women's health website.
16032484|NCT02648594|Device|Hook wire CT guided|The intervention consist to place a CT-guided hook wire in lung patient
16032485|NCT02648581|Drug|Subcutaneous Ustekinumab|Injections of ustekinumab at 90 mg at week 0, week 4 and week 16. Patients in treatment failure at week 24 will terminate the study. Responder patients at week 24 will receive additional 2 injections of ustekinumab at week 28 and week 40 with a final evaluation at week 52.
16035340|NCT02628496|Device|Confocal laser microlaryngoscopy|
16032486|NCT02648568|Behavioral|Hypnosis plus relaxation|The patient will have 20 min of Jacobson 's type relaxation, with sequential contraction and relaxation of limb muscles followed by an induction of hypnosis based on the preferential channel of each patient and, during trance, recommendation to assimilter the bed room and bed to a safe place
16032487|NCT02648568|Behavioral|Relaxation|The patient will have 20 min of Jacobson 's type relaxation, with sequential contraction and relaxation of limb muscles
16032488|NCT02648555|Behavioral|Daily walking|Participants will be instructed to walk briskly for >40 minutes, 7 days a week.
16032489|NCT02648555|Behavioral|Dietary recommendations|"Participants will be instructed to eat at least two daily servings of meat, poultry, fish (e.g. 2 g/kg) or other protein-rich food, starting at least one week before embryo transfer and continuing until delivery. They will be also recommended to avoid high-glycemic index meals (high-carbohydrate, low-fiber), such as snacks, candies, fiber-free juices, coconut water, and sugar-sweetened beverages, particularly carbonated soft drinks and sport drinks.
~Patients suffering from nausea usually do not tolerate solid food. As a result, fiber-free juices and sugar-sweetened beverages account of most of their caloric intake, which may cause non-adherence to the protocol. Women with nausea or vomiting will be treated with ondansetron."
16032490|NCT02648542|Other|Compensatory auditory stimulation|Compensating for peripheral hearing loss by adjusting sound levels based on individual audiogram.
16032491|NCT02648542|Device|transcranial direct current stimulation|Low-current electrical brain stimulation
16032492|NCT02648542|Other|Combined CAS and tDCS|Combined auditory and electrical stimulation
16032493|NCT02648542|Other|Sham stimulation|Sham stimulation
16032494|NCT02648529|Procedure|MRI|"Patients are investigated with the following sequences:
~High-resolution 3D T1-weighted anatomical MRI.
~DTI with 48 directions (to examine white matter)"
16032495|NCT02648529|Procedure|functional MRI (fMRI)|"fMRI investigations will be focused on :
~language: investigation on possible atypical language networks in children with epilepsy. The fMRI task is a silent verb generation.
~Social cognition: investigations on social cognition skills
~Memory :
~Declarative memory: investigations on the pattern of activations in the brain associated with successful memory formation and changes from childhood to adolescence
~Working memory: A verbal and a spatial working memory task has been chosen, and is an adaptation of two published cross-sectional studies of working memory from Gabrieli and Sowell groups."
16032496|NCT02648529|Behavioral|neuropsychological assessment|Patients undergo a repeated annual neuropsychological assessment over the five years of their participation in the project.
16032497|NCT02648516|Combination Product|Conventional plus AAIT|Participants will receive ART and taken i.v., at a dose of 2-3*10E8 MNCs/kg body at baseline, week 1 and 2.
16032498|NCT02648503|Drug|Deep neuromuscular block|Using rocuronium and reversal with sugammadex
16032499|NCT02648503|Drug|Moderate neuromuscular block|Using rocuronium and reversal with neostigmine (1 to 2 mg) and atropine (0.5 to 1 mg)
16032500|NCT02648490|Drug|HLX07|recombinant human anti-EGFR monoclonal antibody against cancers
16032501|NCT02648490|Drug|Acetaminophen|Acetaminophen 500 mg PO 30 minutes before the infusion of HLX07.
16032502|NCT02648490|Drug|dexamethasone|dexamethasone 10 mg intravenous infusion for 10 minutes before the infusion of HLX07.
16032503|NCT02648490|Drug|diphenhydramine|diphenhydramine 30 mg intravenous infusion for 10 minutes before the infusion of HLX07.
16032504|NCT02648490|Drug|5-HT3 inhibitor|If the patient experience grade 2 or 3 nausea and vomiting during the first infusion of HLX07, the addition of 5-HT3 inhibitor may be included in the premedication before subsequent infusions.
16032505|NCT02648477|Drug|Anastrozole|Given PO
16032506|NCT02648477|Drug|Doxorubicin Hydrochloride|Given IV
16032507|NCT02648477|Drug|Exemestane|Given PO
16032508|NCT02648477|Other|Laboratory Biomarker Analysis|Correlative studies
16032509|NCT02648477|Drug|Letrozole|Given PO
16032510|NCT02648477|Biological|Pembrolizumab|Given IV
16032511|NCT02648464|Drug|Hydroxychloroquine|
16032512|NCT02648464|Drug|Placebo|
16032513|NCT02648451|Dietary Supplement|AYMES ROME|AYMES Rome is a powder, designed to be mixed with 250 ml water to make up a juice style ONS. When made up AYMES Rome provides 300 kcal (1 kcal / ml) and 10.7 g protein. It is not designed to be used as a sole source of nutrition. It is a Food for Special Medical Purposes (FSMP) and must therefore be used under medical supervision.
16032514|NCT02648438|Drug|AZD7594 Solution for infusion (150 μg intravenous formulation)|Solution for infusion 0.01 mg/ml; AZD7594 150 μg IV
16032515|NCT02648438|Drug|AZD7594 Oral suspension (1200 μg oral formulation)|0.1 - 10 mg/g oral solution; AZD7594 1200 μg oral
16032516|NCT02648438|Drug|AZD7594 Inhalation powder (400 μg) by DPI Device 1 (monodose inhaler)|Inhalation powder, hard capsules 400 μg Monodose inhaler; AZD7594 400 μg by dry powder inhaler (DPI) Device 1 (Monodose inhaler)
16032517|NCT02648438|Drug|AZD7594 Inhalation powder (400 μg) by DPI device 2 (multiple-dose inhaler)|Inhalation powder, multiple-dose dry powder inhaler (DPI) 400 μg; AZD7594 400 μg by DPI Device 2 (multiple-dose DPI)
16032518|NCT02648438|Drug|AZD7594 Pressurized inhalation suspension (400 μg) by pMDI|Inhalation suspension 200 μg; AZD7594 400 μg by pressurized metered-dose inhaler (pMDI); 2 puffs x 200 μg = 400 μg
16032519|NCT02648425|Drug|ASLAN001|ASLAN001 400mg BID daily; ASLAN001 500mg BID daily; or ASLAN001 300mg BID daily
16032520|NCT02648425|Drug|cisplatin + capecitabine|Cisplatin 80 mg/m2 IV infusion and capecitabine 1,000 mg/m2 orally BID for 14 days every 3 weeks
16032521|NCT02648425|Drug|cisplatin + 5-fluorouracil (or+ Leucovorin)|"Cisplatin 80 mg/m2 IV infusion and 5-fluorouracil 800 mg/m2/day IV infusion for 5 days every 3 weeks;
~Or
~Cisplatin 35 mg/m2 24-hour infusion for day 1 and day 8, 5-fluorouracil 2,000 mg/m2 and Leucovorin 300mg/m2 24-hour infusion for day 1, day 8 and day 15 every 4 weeks."
16032522|NCT02648412|Drug|ketamine|bolus 1 mg/kg
16032523|NCT02648412|Procedure|Tetanic stimulations of incremental intensities|10-20-30-40-60 milliamps on the patient's left forearm
16032524|NCT02648399|Procedure|surgery：BCND（bilateral central lymph node dissection）|
16032525|NCT02648399|Procedure|surgery：UCND（unilateral central lymph node dissection）|
16032526|NCT02648386|Procedure|Laparoscopic surgery|Completely resected rectal tumor.
16032527|NCT02648386|Device|NeuroRegen scaffold transplantation|After completely resected rectal tumor, exposed pelvic autonomic nerves, and then transplanted NeuroRegen scaffold to the nerve.
16150558|NCT01776528|Biological|NGM282|
16032529|NCT02648386|Biological|NeuroRegen scaffold/HUC-MSCs transplantation|Completely resected rectal tumor, exposed pelvic autonomic nerves, and then transplanted NeuroRegen scaffold loaded with 5 million human umbilical cord mesenchymal cells to the nerve.
16032530|NCT02648373|Behavioral|Patient Education|An educational video was watched based on Consumer Reports Choosing Wisely patient education supporting the recommendation that imaging is not helpful early for low back pain and the best strategy is to remain as active as possible. Key themes were discussed with a physical therapist and the patient's questions were answered.
16032531|NCT02648373|Other|Control|Patients receive no additional intervention. They will begin physical therapy and receive care at the therapist's discretion.
16032532|NCT02648360|Behavioral|Text Messaging|The content of the program will be delivered via 3 weekly text messages over a 4 month period of time.
16032533|NCT02648347|Drug|vadadustat|oral tablet
16032534|NCT02648347|Drug|darbepoetin alfa|Subcutaneous
16032535|NCT02648334|Device|IN.PACT drug coated balloon|
16032536|NCT02648334|Device|Lutonix drug coated balloon|
16032537|NCT02648321|Behavioral|Motivational Interviewing|Motivational Interviewing is a patient-centered, tailored counselling intervention for exercise, through which patients' motives to change are identified. Personal ideas and ambivalence are explored. The discrepancies between the present behavior and the patient's own future goals are amplified. The patient's intrinsic motivation for change is increased through the process.
16032538|NCT02648321|Behavioral|Health Education|General education about healthy lifestyle and diet.
16032539|NCT02648308|Behavioral|Obesity Management Workshop|Workshop provided to first year medical residents to improve confidence and skill when conducting weight management visits with patients
16032540|NCT02648295|Procedure|Effects of IV TXA on TEG in patients undergoing THA or TKA|Subjects will undergo surgery per standard of care. All subjects will have 3 additional vials of blood drawn to evaluate TEG.
16032541|NCT02648282|Drug|Cyclophosphamide|200 mg/m2 is to be administered as a 30 minute IV infusion one day prior to GVAX for a total of 8 doses.
16032542|NCT02648282|Drug|GVAX|2.5E8 cells of each cell line (Panc 6.03/Panc 10.05) for a total of 5E8 cells is to be administered one day after CY and pembrolizumab for a total of eight doses.
16032543|NCT02648282|Drug|Pembrolizumab|200 mg will be administered as a 30 minute IV infusion one day prior to the GVAX pancreas vaccine for a total of 8 doses.
16032544|NCT02648282|Radiation|SBRT|Patients will receive SBRT (6.6 Gy for 5 days) with the second dose of combined immunotherapy (CY/Pembrolizumab/GVAX).
16032545|NCT02648269|Drug|SEL-110|
16032546|NCT02648269|Biological|SEL-212|
16032547|NCT02648269|Biological|SEL-037|
16032548|NCT02648256|Other|Polymerase Chain Reaction on Oropharyngeal rinse|
16032549|NCT02648243|Behavioral|Structured intervention at discharge and tailored follow up post discharge|"At discharge, pharmacist-delivered personalized intervention would include the following (30-60 minutes session): The pharmacist will perform medication reconciliation and will check the appropriateness and accuracy of discharge medications. - Other potential interventions that could be done by the pharmacist include in addition to medication initiation: dose and/or frequency optimization, changing ACEI with ARB if necessary, changing to another statin if needed, identification of inappropriate or duplicated therapy, etc.
~The pharmacist will ensure that a follow-up plan for medication monitoring after discharge is communicated to the patient. The pharmacist will also provide a tailored and thorough counseling to the patient. In addition to the pharmacist delivered intervention at discharge (as described above), the study pharmacist will schedule 2 follow-up sessions (30-60 minutes each session) with the patients at 4 weeks of discharge and at 8 weeks of discharge."
16032550|NCT02648230|Device|St. Jude Medical Pressure Wire|FFR measurement will be obtained with a PW with the FFR measurement obtained by using a MC within the same subject across the same target lesion at the same time
16032551|NCT02648230|Device|ACIST Navvus Microcatheter|FFR measurement will be obtained with a MC with the FFR measurement obtained by using a PW within the same subject across the same target lesion at the same time
16032552|NCT02648217|Drug|insulin degludec/insulin aspart|Injected subcutaneously (s.c., under the skin)twice daily. The pre-trial insulin will be discontinued.
16032553|NCT02648217|Drug|biphasic insulin aspart|Injected subcutaneously (s.c., under the skin)twice daily. The pre-trial insulin will be discontinued.
16032554|NCT02648204|Drug|semaglutide|Administered subcutaneously (s.c., under the skin) once-weekly.
16032555|NCT02648204|Drug|Dulaglutide|Administered subcutaneously (s.c., under the skin) once-weekly.
16032556|NCT02648191|Device|NeuroCoach II Stim|"A noninvasive vagus nerve stimulator consists of two components. An electrode is placed in the left ear concha and will be used by the patient for 4-5 hours per day in segments of 1 hour minimum.
~For this intervention, the stimulations are active."
16032557|NCT02648191|Device|NeuroCoach II Stim|"A noninvasive vagus nerve stimulator consists of two components. An electrode is placed in the left ear concha and will be used by the patient for 4-5 hours per day in segments of 1 hour minimum.
~For this intervention, the stimulations are inactive."
16032558|NCT02648178|Device|HALO|HALO manufactures e-cigarettes which will be distributed to patients. Two products, the G6 and tank model will be used.
16032559|NCT02648165|Behavioral|Attention Bias Modification|Computer based Attention Bias Modification
16032560|NCT02648165|Behavioral|Sham Attention Bias Modification|Computer based Sham Attention Bias Modification
16032561|NCT02648165|Behavioral|Acceptance and Commitment Therapy|Acceptance and Commitment Therapy delivered in a group therapy setting
16032562|NCT02648152|Device|Osteoarthritis|Total Hip Arthroplasty
16032563|NCT02648139|Drug|Dentifrice|3x/day for 7 days.
16032564|NCT02648126|Procedure|Pure Red Cell Aplasia diagnostic confirmation|"Patients who meet the appropriate criteria in the selection period will be subject to Pure Red Cell Aplasia diagnostic confirmation by collecting 20 mL of blood in dialysis units.
~The samples will be processed, aliquoted and transported to Bio-Manguinhos, where depart periodically (according to the volume of samples) to the reference laboratory Sce Immunologie et d'Hématologie biologiques Hôpital Saint Antoine, where the dosage of antibody will be held anti epoetin alfa"
16032565|NCT02648113|Procedure|Restrictive transfusion|Transfusions are withheld unless Hb is <= 8 g/dL, with a target Hb of 8 to 10 g /dL
16032566|NCT02648113|Procedure|Liberal transfusion|transfusions are allowed as soon as Hb <= 10 g/dL with a target of 11 g /dL
16032571|NCT02648074|Other|Co-culture formation|Eosinophil and linear bronchial smooth muscle cell co-culture formation. Airway smooth muscle cell proliferation, eosinophil adhesion to the bronchial smooth muscle cells, the role of eosinophil integrins in the airway remodelling process is assessed in individual formed co-culture
16032572|NCT02648048|Drug|Pirfenidone|Pirfenidone will be administered as per the dosage schedule mentioned in arm description.
16032573|NCT02648048|Drug|Vismodegib|Vismodegib will be administered as per the dosage schedule mentioned in arm description.
16032574|NCT02648035|Biological|Tocilizumab|Subcutaneous Tocilizumab according to approved label.
16032575|NCT02648022|Behavioral|Brief mental health interventions and case management|The mental health practitioner (MHP) provided brief interventions and follow up sessions designed to reduce the risk factors that are barriers to successful antiviral treatment (substance use, depression, PTSD. Second, MHP provided ongoing case management services to these patients, with an emphasis on navigating the complex HCV care process, preparation for antiviral treatment, and managing the treatment process (adherence, side effects, etc). Third, the MHP also activated the patient and facilitate the medication management of depression and other psychiatric disorders when possible by collaborating with the prescribing HCV physicians.
16032576|NCT02648009|Drug|Hyperpolarized (13) Pyruvate Injection|MRI with Hyperpolarized Pyruvate (13) Injection
16032577|NCT02648009|Drug|Gadolinium|MRI with Gadolinium
16032578|NCT02647996|Procedure|MRI: functional (resting state) and structural (DTI)|One hour brain MRI recording without active task for the patient, no sedation
16032579|NCT02647983|Drug|Hyperpolarized Pyruvate (13C) Injection|Hyperpolarized Pyruvate (13C) Injection is a MRI contrast agent.
16032580|NCT02647970|Behavioral|PUFA-Cys/Met diet|Provision of food and supplements that are rich in polyunsaturated fatty acids (PUFA, n-3 and n-6) and low in the amino acids cysteine (Cys) and methionine (Met).
16032581|NCT02647970|Behavioral|SFA+Cys/Met diet|Provision of food and supplements that are rich in saturated fatty acids (SFA) and the amino acids cysteine (Cys) and methionine (Met).
16032582|NCT02647957|Procedure|Code Stroke|Apply a protocol called Code Stroke that involves the entire care chain from emergency teams outpatient specialists of Neurology, Internal Medicine, Radiology or Intensitivos Care, among other hospital areas.
16032583|NCT02647944|Drug|Liraglutide|Initiate at 0.6mg S.C. daily for 1 week; subjects will return to the Clinical Research Unit (CRU) each week until an increase by 0.6mg/day in weekly intervals to a dose of 3.0 mg/day is achieved (~4 weeks). Once maintenance dose of 3.0 mg is achieved, subjects will return approximately every 4 weeks to obtain new supply of study medication.
16032584|NCT02647944|Drug|Placebo|
16032585|NCT02647931|Behavioral|Voice therapy for Muscle Tension Dysphagia|Voice therapy for Muscle Tension Dysphagia
16032586|NCT02647918|Drug|Sotagliflozin|Single dose
16032587|NCT02647918|Drug|Sotagliflozin|2 single doses
16032588|NCT02647905|Device|Continuous Glucose Monitoring System|Accuracy and safety assessment of a continuous glucose monitoring device
16032589|NCT02647892|Drug|lidocaine|local anesthesia
16032590|NCT02647892|Drug|sodium bicarbonate|additional drug added to lidocaine
16032591|NCT02647866|Drug|KHK4083|IV Infusion
16032592|NCT02647866|Drug|Placebo|IV Infusion
16032593|NCT02647853|Drug|TAT4 Gel concentration A|
16032594|NCT02647853|Drug|TAT4 Gel concentration B|
16032595|NCT02647853|Drug|Placebo|
16032596|NCT02647840|Behavioral|voice therapy|voice therapy based on Estill Voice Model The study will provide primarily direct intervention, i.e. working directly on the voice with voice exercises based on the Estill model of voice. This will be structured and hierarchical. Participants will work through the content one-to-one with the voice specialist SLT at their level and pace, to suit their specific vocal needs, again reflecting current clinical practice. Participants may need fewer or more than four sessions to gain the required skills. Should patients need more than six session of voice therapy to recover their voice fully, final assessment for the study purposes will be taken at session 6, and voice therapy will continue as required.
16032597|NCT02647827|Other|Lifestyle management|All women will receive lifestyle management instructions at the baseline visit, before randomization. The lifestyle management involves one initial counselling session in connection with the baseline visit, which includes information about the importance of weight management, healthy diet and physical activity.
16032598|NCT02647827|Device|Acupuncture|Disposable, single-use, sterilized CE marked needles made of stainless steel, 0.25 x 30 mm and 0.30 x 40/50 mm will be inserted to a depth of 15-40 mm in segmental acupuncture points located in abdominal and leg muscles, with innervations corresponding to the ovaries and the pancreas. Two sets of acupuncture points will be alternated every second treatment.
16032599|NCT02647827|Drug|Metformin|Oral metformin 500 mg three times daily, in total 1500 mg per day. To reduce gastrointestinal side-effects of metformin, the dose will be slowly escalated starting with 500 mg daily during the first week, increasing to 500 mg twice per day during the second the week, and 500 mg three times daily, morning, lunch and dinner from the third week in total 16 weeks including the 3 weeks step-up phase (i.e. 4 months).
16032600|NCT02647814|Behavioral|Salud al Día|A pilot randomized controlled trial comparing the effectiveness of a parent support intervention consisting of periodic text messages and educational support (video, collateral materials),and usual care on the healthcare engagement of LEP Latino parents during their child's first year and to examine its impact on healthcare utilization and primary care quality.
16032601|NCT02647801|Behavioral|Mindfulness intervention|"Mindfulness is practiced with a weekly computer based guided breathing meditation in which one's own breath has to be counted repetitively from 1 to 9. Participants have to press a specific button for breaths 1 to 8 and then press another button for breath 9 on a keyboard. During this practice they put on headphones and listen to a voice that guides them through breathing meditation. A click sound will occur if breath is miscounted (Levinson et al., 2014). After each computer based breathing meditation the experimenter and participants exchange meditation experiences and views. After the first mindfulness training participants in the experimental group are also able to practice mindfulness at home by listening to audio files on the mobile phone (bodyscan or breathing meditation)."
16032602|NCT02647788|Drug|Acetaminophen/Ibuprofen|After hand surgery, take Acetaminophen 650 mg/Ibuprofen 400 mg every 6 hours as needed for pain until postoperative clinic visit
16032657|NCT02647424|Drug|Clomiphene|After one month of washout period, clomiphene 50 mg daily from day 2 to day 6 given
16032603|NCT02647788|Drug|Acetaminophen/Codeine|After hand surgery, take Acetaminophen 300mg/Codeine 30 mg every 6 hours as needed for pain until postoperative clinic visit
16032604|NCT02647775|Procedure|multi-port VATS|Patients with thoracic surgical diseases who underwent VATS will be recruited into this study to investigate the postoperative pain , physiologic and immunologic impacts of two different approaches for minimally invasive thoracic surgery.
16032605|NCT02647775|Procedure|single-port VATS|Patients with thoracic surgical diseases who underwent VATS will be recruited into this study to investigate the postoperative pain , physiologic and immunologic impacts of two different approaches for minimally invasive thoracic surgery.
16032606|NCT02647762|Drug|CF101 1 mg|CF101 tablets, 1mg BID for 12 weeks
16032607|NCT02647762|Drug|CF101 2 mg|CF101 tablets, 2 mg BID for 12 weeks
16032608|NCT02647762|Drug|Placebo|Placebo tablets, 1mg BID for 12 weeks
16032609|NCT02647762|Drug|MTX|MTX 5 mg tablets, given once weekly at 10 mg/week (2 tablets) for the first 2 weeks, then 15 mg/week (3 tablets) for the next 2 weeks, then 20 mg/week (4 tablets) thereafter, for 12 weeks.
16032610|NCT02647749|Device|Cardioinsight® mapping system|
16032611|NCT02647749|Other|Conventional method without non-invasive mapping|
16032612|NCT02647736|Other|Hypertonic saline infusion|
16032613|NCT02647723|Dietary Supplement|DHA|2 dietary supplement gel capsules providing 450 mg of DHA twice daily by oral intake for 24 weeks
16032614|NCT02647723|Dietary Supplement|Sugar pill|2 dietary supplement gel capsules providing 450 mg of soybean oil twice daily by oral intake for 24 weeks
16032615|NCT02647710|Behavioral|PHAT Life Intervention|HIV Prevention behavioral health intervention
16032616|NCT02647710|Behavioral|Health Promotion Control|Behavioral health intervention control
16032617|NCT02647697|Drug|Radiprodil oral|"Active Substance: Radiprodil
~Pharmaceutical Form: dry granules for oral suspension
~Concentration: 30 mg
~Route of Administration: oral use"
16032618|NCT02647684|Behavioral|Self-Directed Triple P|10 Week Triple P Self directed workbook
16032619|NCT02647671|Drug|Aquamin®|90 days of Aquamin
16032620|NCT02647671|Drug|Calcium Carbonate|90 days of Calcium Carbonate
16032621|NCT02647671|Drug|Placebo|90 days of placebo
16032622|NCT02647658|Behavioral|Guideline Based Care plus Psychologically Informed Physical Therapy|PCP care is enhanced with a prompt referral to physical therapy (PT) that includes psychologically informed coaching directed towards education and reduced fear of movement
16032623|NCT02647658|Behavioral|Guideline Based Care (GBC)|Management decisions are made between PCPs and patients with the guidance of best evidence but with no specific directives
16032624|NCT02647645|Device|Transcranial direct current stimulation|Direct current stimulation at a current of 1.5 mA with anode at F3 (left dorsolateral prefrontal cortex) and cathode at Fp2 (right frontal pole) for a period of 20 minutes each for 6 sessions over two weeks simultaneously with cognitive training.
16032625|NCT02647645|Procedure|Cognitive training|Computer delivered intervention designed to improve cognitive speed and executive functioning for a period of 20 minutes each for 6 sessions over two weeks.
16032626|NCT02647645|Device|Sham transcranial direct current stimulation|Direct current stimulation at a current of 1.5 mA with anode at F3 (left dorsolateral prefrontal cortex) and cathode at Fp2 (right frontal pole) for a period of one minute to simulate active treatment applied in 6 sessions over two weeks.
16032627|NCT02647632|Drug|Grazoprevir/Elbasvir|
16032628|NCT02647632|Drug|Sofosbuvir|
16032629|NCT02647632|Drug|Ribavirin|
16032630|NCT02647619|Drug|Xiapex|Injection of collagenase of primary dupytren cord
16032631|NCT02647619|Procedure|Needle aponeurotomy|26 G needle multiple perforation tecqnique with local anesthetic
16032632|NCT02647606|Procedure|MILS|MILS(Manual in-line stabilization) will be applied during intubation. With MILS, different kinds of laryngoscope will be evaluated in a simulated difficult airway.
16032633|NCT02647606|Device|McGrath videolaryngoscope|McGrath videolaryngoscope will be used for intubation
16032634|NCT02647606|Device|Pentax AWS videolaryngoscope|Pentax AWS videolaryngoscope will be used for intubation
16032635|NCT02647606|Device|Macintosh laryngoscope|Macintosh laryngoscope will be used for intubation
16032636|NCT02647567|Other|Caffeine Intake|The experimental group ingest 500 mg of caffeine before (60 min) aerobic exercise (procedure double blind), and perform a battery of neuropsychological and psychomotor tests. 1 min and 30 min after the exercise the subjects perform a new battery of neuropsychological and psychomotor tests.
16032637|NCT02647567|Other|Placebo Intake|The control group ingest 500 mg of placebo before (60 min) aerobic exercise (procedure double blind), and perform a battery of neuropsychological and psychomotor tests. 1 min and 30 min after the exercise the subjects perform a new battery of neuropsychological and psychomotor tests.
16032638|NCT02647554|Drug|ulinastatin|ulinastatin 400,000 IU every 8 hours for 10 days
16032639|NCT02647554|Drug|Placebo|matching placebo every 8 hours for 10 days
16032640|NCT02647541|Dietary Supplement|Nutritional intervention|Consultation with a dietitian, nutritional recommendations to achieve the expected energy expenditure, with or without supplementation with enriched formulas.
16032641|NCT02647528|Device|Chromogenix Regenlite Transform Treatment|Pulse Dyed Laser - 7mm spot size 3-3.6 J/cm2
16032642|NCT02647528|Device|Chromogenix Regenlite Transform Placebo|Pulse Dyed Laser - 7mm spot size 0 J/cm2
16032643|NCT02647515|Drug|ranibizumab|
16032644|NCT02647502|Other|Diet|Diet, standardized to the 50th percentile for macronutrients, will be provided at varied calorie levels as described.
16032645|NCT02647489|Biological|PAMVAC|
16032646|NCT02647489|Biological|Alhydrogel|
16032647|NCT02647489|Biological|GLA-SE|
16032648|NCT02647489|Biological|GLA-LSQ|
16032649|NCT02647489|Other|Placebo|
16032650|NCT02647476|Dietary Supplement|Immunomodulating nutrition (Reconvan)|protein rich, isocaloric, no-residue diet including arginine, glutamines and omega-3 fatty acids - Reconvan, Fresenius Kabi
16032651|NCT02647476|Dietary Supplement|Standard nutrition (Peptisorb)|oligopeptide, low-fat, isocaloric, non-residue diet
16032652|NCT02647463|Behavioral|Attachment and Biobehavioral Catch-up (ABC)|
16032653|NCT02647450|Other|GIANT Completed patient|Patients identified in the GIANT clinic and who fulfill the inclusion criteria will be sent a 9 page questionnaire. Upon receipt the questionnaire will be sent to the patient's GP for validation.
16032659|NCT02647385|Drug|Block with lidocaine for SAM and PEC I block|"Patients could be submitted to general anesthesia or general anesthesia associated with SAM and PEC I block with lidocaine before mastectomy.
~Interventions: include pain assessment, inflammatory response and opioid consumption."
16032660|NCT02647372|Procedure|Subthalamic nucleus|Surgery will be performed in 15 patients with DBS target to the subthalamic nucleus
16032661|NCT02647372|Procedure|Globus pallidus|Surgery will be performed in 15 patients with DBS target to the globus pallidus nucleus
16032662|NCT02647359|Drug|Ataluren|Ataluren oral suspension will be administered as per the dose and schedule specified in the respective arms.
16032663|NCT02647359|Drug|Placebo|Placebo will be administered as per the schedule specified in the respective arm.
16032664|NCT02647346|Device|Daily use of podimetrics smart-foot mat|
16032665|NCT02647333|Dietary Supplement|Omega-3 Fatty Acid|Experimental: Omega-3 fatty acid In the intervention period the participants will receive a daily supplement of omega-3 fatty acids for 8 weeks, where the dosage are 3 and 4 g/day for women and men, respectively. The omega-3 supplement is a hydrolyzed and reesterified TAG fish oil, containing 33 area percent eicosapentaenoic acid and 22 area percent docosahexaenoic acid.
16032666|NCT02647333|Dietary Supplement|Omega-6 Fatty Acid|Experimental: Omega-6 fatty acid In the intervention period the participants will receive a daily supplement of omega-6 fatty acid for 8 weeks, where the dosage are 20 and 27 g/day for women and men, respectively. The omega-6 supplement is a high-quality organic, cold pressed and filtered safflower oil, containing 68-83% linoleic acid, 5-15% saturated fatty acid, 8-21% oleic acid, 0,0-0,5% ALA and maximum 2% other fatty acids.
16032667|NCT02647320|Drug|Sitagliptin 100 mg|Two sitagliptin 50 mg tablets, over-encapsulated to provide a once-daily dose of 100 mg, for oral administration
16032668|NCT02647320|Drug|DS-8500a 25mg|DS-8500a 25mg tablet for oral administration
16032669|NCT02647320|Drug|Placebo Tablet|Placebo matching DS-8500a tablet for oral administration
16032670|NCT02647320|Drug|Placebo Capsule|Placebo matching sitagliptin over-capsule for oral administration
16032671|NCT02647307|Drug|DS-1040b|Single 12-hour intravenous infusion of DS-1040b (20 mg)
16032672|NCT02647294|Dietary Supplement|Maxicor|Patients with NAFLD will be randomly allocated to receive or n-3 PUFA (3,6 g/day, oral treatment) or placebo (1:1).
16032673|NCT02647294|Other|Placebo|Patients with NAFLD will be randomly allocated to receive or placebo or n-3 PUFA for 12 months (1:1).
16032674|NCT02647281|Drug|GSK3389404|GSK3389404 is supplied as solution for injection vial. Each vial contains 100 mg/mL of GSK3389404. It's physical appearance is clear colourless to slightly yellow solution.
16032675|NCT02647281|Drug|Matching Placebo|Placebo is supplied as solution for injection vial. It's physical appearance is clear colourless solution.
16032676|NCT02647268|Drug|Oxytocin|Oxytocin, 10-5M solution
16032677|NCT02647268|Drug|Magnesium Sulphate|Magnesium sulphate, 3.5mM solution
16032678|NCT02647255|Procedure|Plasma Exchange (PE)|PE treatment>7 within 3weeks; Volume exchanged: 60ml/kg/course; Replacement fluid: 5% Albumin or fresh frozen plasma; PE was performed by dialysis machine (IQ-21, Asahi Japan) and plasma separator (OP- 08W, Asahi Japan)
16032679|NCT02647255|Drug|Methylprednisolone pulse|methylprednisolone 7-15mg/kg/d 3 times, Qd. or Qod
16032680|NCT02647242|Behavioral|Auto rehabilitation program of gait with Beat Health device.|The auto-rehabilitation program will consist in an outside walk, during 5 sessions of 30 minutes per week during 4 weeks with the beatHealth device, delivering the optimal rythmic auditory cueing. The device will associate an Android smartphone, hold at the belt, connected by bluetooth to a headphone and to two sensors strapped to the ankles. The patient will transfer the data collected by BeatHealth to a secured website and will complete the agenda
16032681|NCT02647229|Other|Isosmotic bowel cleansing preparation|Isosmotic Preps contain polyethylene glycol (PEG) and are osmotically balanced, high-volume, nonabsorbable, and nonfermentable electrolyte solutions.
16032682|NCT02647229|Other|Colonic Hyrdrotherapy|FDA approved method of colon cleansing using constant warm water lavage with a contained temperature and pressure controlled device administered by a trained technician
16032683|NCT02647216|Behavioral|Mindfulness Based Cognitive Therapy|Weekly MBCT sessions consist of: a) mindfulness practice including breath-focused sitting meditation, body scanning, and mindful stretching; b) review of previous weeks' homework and an overview of the current week's homework; c) barriers to completing the homework. Homework includes: a) practicing the mindfulness exercise reviewed in class using the CDs provided to each participant (guided practice of the relevant exercise); b) maintaining a calendar of pleasant events; c) mindfully engaging in activities of daily living; and d) logging practice efforts in a daily log.
16032684|NCT02647216|Behavioral|Treatment as Usual|Subjects randomized to the Treatment as Usual group will be advised to seek help from their family doctor or other sources as they normally would if they encountered symptomatic deterioration or other difficulties over the course of the study.
16032685|NCT02647203|Drug|Self-administered fluoridated dentifrices|Elderly participants will be instructed to self administer toothpastes, twice per day. Toothpastes will be provided.
16032686|NCT02647190|Drug|Erwinia Chrysanthemi asparaginase|
16032687|NCT02647177|Other|Pancreatic Cyst Aspiration|10 CC of pancreatic cyst aspiration
16032688|NCT02647151|Drug|METHYLAMINOLEVULINATE HYDROCHLORIDE|"This is an intrapatient randomized clinical trial. All patients participating in the trial will receive both, experimental and control treatment, randomization will be used to determine side (right or left for treatment). Three visits will be scheduled. In the first visit epidemiological data will be collected , Actinic Keratoses are counted and drawn in a transparent template and also a photograph of each side. In that first visit treatment the PDT will be also performed, the degree of fluorescence, the pain and the degree of immediate local reaction will be measured.
~skin after PDT. In the second visit, to be held at 2 or 3 days, the delayed local reaction degree will be assessed. And in the third visit, held a month of PDT the clinical response and patient satisfaction will be assessed."
16032731|NCT02646865|Behavioral|Self-Compassion Enhanced Cognitive-Behavioral Therapy|12 group sessions of CBT for social anxiety based on Heimberg & Becker's (2002) protocol with additional self-compassion exercises integrated into the treatment
16032732|NCT02646865|Behavioral|Cognitive-Behavioral Therapy|12 group sessions of CBT for social anxiety based on Heimberg & Becker's (2002) protocol
16032733|NCT02646852|Drug|PLX038|
16033455|NCT02641899|Drug|Acetaminophen|Oral acetaminophen 1000 mg on Day 1 and Day 27
16032689|NCT02647151|Drug|AMINOLEVULINIC ACID HYDROCHLORIDE|"This is an intrapatient randomized clinical trial. All patients participating in the trial will receive both, experimental and control treatment, randomization will be used to determine side (right or left for treatment). Three visits will be scheduled. In the first visit epidemiological data will be collected , Actinic Keratoses are counted and drawn in a transparent template and also a photograph of each side. In that first visit treatment the PDT will be also performed, the degree of fluorescence, the pain and the degree of immediate local reaction will be measured.
~skin after PDT. In the second visit, to be held at 2 or 3 days, the delayed local reaction degree will be assessed. And in the third visit, held a month of PDT the clinical response and patient satisfaction will be assessed."
16032690|NCT02647138|Other|white noise|exposure to white noise
16032691|NCT02647125|Drug|Huachansu|Huachansu 20 ml/m2/d, intervenous infusion, once a day, 5 times per week, during the period of radiation.
16032692|NCT02647125|Radiation|thoracic radiation|A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks.
16032693|NCT02647112|Other|Bladder EpiCheck|Urine test for the monitoring of bladder cancer recurrence
16032694|NCT02647099|Drug|Acetylsalicylic acid|
16032695|NCT02647099|Drug|Placebo|
16032696|NCT02647086|Drug|Dupilumab|
16032697|NCT02647086|Drug|Midazolam|Cytochrome P450 substrate
16032698|NCT02647086|Drug|Omeprazole|Cytochrome P450 substrate
16032699|NCT02647086|Drug|Warfarin|Cytochrome P450 substrate
16032700|NCT02647086|Drug|Caffeine|Cytochrome P450 substrate
16032701|NCT02647086|Drug|Metoprolol|Cytochrome P450 substrate
16032702|NCT02647073|Device|Canary 01 Mobile Vital Signs Monitoring Device|The prototype has several main components, including several commercially available sensors to measure heart rate, respiration, and motion data, an enclosed case containing circuitry for processing and transmitting data, and a mobile phone/system interface to store and transmit data.
16032703|NCT02647047|Procedure|Spinal analgesia|Administration of morphine 0.2 mg in subarachnoid space.
16032704|NCT02647047|Procedure|Epidural analgesia|Bolus of ropivacaine 0.2% 4-6 mL followed by continuous epidural infusion of ropivacaine 0.2% 99 mL + sufentanil 50 mcg/mL 1 mL in epidural space
16032705|NCT02647047|Procedure|Transversus Abdominis Plane block|Administration of ropivacaine 0.375% 20 mL in the plane between the internal oblique and the transversus abdominis muscles, bilaterally
16032706|NCT02647047|Procedure|Surgical wound infiltration|Infiltration of the surgical wound with ropivacaine 0.75% 10- 20 mL
16032707|NCT02647047|Drug|Acetaminophen|Administration of 1000 mg of acetaminophen 40 minutes before ending of surgery followed by intravenous administration of 1000 mg every 8 hours
16032708|NCT02647047|Drug|Ketorolac|Administration of a non-steroidal antinflammatory drug (ketorolac 30 mg) as a rescue therapy
16032709|NCT02647047|Drug|Ropivacaine|Epidural bolus of ropivacaine 0.2% 4-6 mL followed by continuous epidural infusion of ropivacaine 0.2% 99 mL
16032710|NCT02647047|Drug|Sufentanil|Epidural continuous epidural infusion of sufentanil 50 mcg/mL 1 mL
16032711|NCT02647047|Drug|Ropivacaine|Administration of ropivacaine 0.375% 20 mL in the plane between the internal oblique and the transversus abdominis muscles, bilaterally to obtain the transversus abdominis plane block
16032712|NCT02647047|Drug|Ropivacaine|Infiltration of the surgical wound with ropivacaine 0.75% 10- 20 mL
16032713|NCT02647034|Other|no intervention|no intervention
16032714|NCT02647021|Behavioral|Therapeutic Exercise|A specialized therapeutic exercise program to address neck and shoulder dysfunction due to spinal accessory nerve damage.
16032715|NCT02647021|Behavioral|Therapeutic + Lower Body Exercise|A combined therapeutic exercise program (as per the comparison arm) plus the addition of lower body resistance exercise
16032716|NCT02647008|Device|TENS|Transcutaneous electrical nerve stimulation (TENS) is a nonpharmacological intervention that activates a complex neuronal network to reduce pain by activating descending inhibitory systems in the central nervous system to reduce hyperalgesia.These small battery powered devices deliver alternating current via cutaneous electrodes positioned near the painful area.
16032717|NCT02646995|Dietary Supplement|modified lipid formulation|Tested oils will be used in liquid form and encapsulated in soft gelatin capsules.
16032718|NCT02646995|Dietary Supplement|Fish oil|Fish oil will be used in liquid form and encapsulated in soft gelatin capsules.
16032719|NCT02646982|Drug|Placebo|A matched placebo will be given once daily for 12 months.
16032720|NCT02646982|Drug|Candesartan|Candesartan will be started at 8 mg orally, once daily. The dose will be increased in 2 week increments to 16 mg and 32 mg orally, once a day, as long as SBP>100 mm Hg, DBP>40 mm Hg and there are no reported symptoms of hypotension (dizziness or weakness). Candesartan will be given for a total of 12 months.
16032721|NCT02646969|Dietary Supplement|Formula regimen 1|
16032722|NCT02646969|Dietary Supplement|Formula regimen 2|
16032723|NCT02646956|Other|sweeteners|Participants tasted a variety of nutritive and nonnutritive sweeteners
16032724|NCT02646930|Procedure|Endometrial biopsy|Endometrial biopsy in women undergoing first IVF cycle
16032725|NCT02646917|Procedure|Aesthetic Microneedling Treatment|Treatment of acne scars on the face and/or back at needle depth settings ranging between 0.25 mm to 2.0 mm, depending on severity and location of scarring.
16032726|NCT02646904|Drug|Nasal Beclomethasone Dipropionate|Standard dose (400 µg/daily as 100 µg 1 spray nos bid) of nebulized Beclomethasone Dipropionate nasal spray for 21 days.
16032727|NCT02646904|Drug|CERCHIO 10 mg/ml OS|For Children < 12 years old 10 drops die (5 mg die) for 21 days. For Children > 12 years old 20 drops die (10 mg die) for 21 days.
16032728|NCT02646891|Biological|Trivalent P2-VP8 Subunit Rotavirus Vaccine|Manufactured and supplied by the Walter Reed Army Institute of Research (WRAIR) Pilot Bioproduction Facility (BPF). The trivalent P2-VP8 vaccine was formulated as a sterile suspension containing a total of 360 µg of protein (120 µg of each P type) per mL adsorbed to aluminum hydroxide (1.125 mg of aluminum per mL in a phosphate buffer, pH 7).
16032729|NCT02646891|Biological|Placebo|Sodium Chloride 0.9%, USP for Injection
16032730|NCT02646878|Device|Harmony 1 Sensor|Use of Harmony 1 Sensor for 10 days when inserted in the arm and abdomen and used with the Guardian Mobile in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least 6 months.
16033456|NCT02641899|Drug|Atorvastatin|Oral atorvastatin 40 mg on Day 2 and Day 28
16032734|NCT02646839|Device|CliniMacs TCR alpha-beta-Biotin system|Graft ex vivo depleted of T cell receptor (TCR) αβ+CD3+/CD19+ cells
16032735|NCT02646826|Other|Placebo|Subjects are treated with Placebo tablets
16032736|NCT02646826|Drug|Paxerol - Dose Level 1|Subjects are treated with the first dose level of Paxerol
16032737|NCT02646826|Drug|Paxerol - Dose Level 2|Subjects are treated with the second dose level of Paxerol
16032738|NCT02646826|Drug|Paxerol - Dose Level 3|Subjects are treated with the third dose level of Paxerol
16032739|NCT02646813|Procedure|Intraluminal Placement|Pt. will have Arndt Endobronchial Blocker placed intraluminally
16032740|NCT02646813|Procedure|Extraluminal Placement|Pt. will have Arndt Endobronchial Blocker placed extraluminally
16032741|NCT02646800|Drug|Micafungin|Injection
16032742|NCT02646787|Behavioral|Active Virtual Reality|The subject is actively engaged in using virtual reality during a painful burn wound care session.
16032743|NCT02646787|Behavioral|Passive Virtual Reality|The subject is passively engaged in using virtual reality during a painful burn wound care session.
16032744|NCT02646774|Drug|Micafungin|Injection
16032745|NCT02646761|Device|InterACTION|InterACTION guided home exercise program paired with standard of care physical therapy
16032746|NCT02646761|Other|Standard of Care Physical Therapy|Physical therapy rehabilitation program
16032747|NCT02646748|Drug|Pembrolizumab|Pembrolizumab 200 mg IV Q3W.
16032748|NCT02646748|Drug|itacitinib|Itacitinib tablets administered orally once daily.
16032749|NCT02646748|Drug|INCB050465|INCB050465 tablets administered orally once daily.
16032750|NCT02646735|Drug|Fulvestrant 500 mg|Fulvestrant 500mg will be given monthly.
16032751|NCT02646735|Drug|Exemestane 25 mg|Exemestane 25mg will be given once daily.
16032752|NCT02646709|Drug|Rocuronium|Low dose rocuronium (0.3 mg/kg) will be injected after induction of anesthesia with ketamine.
16032753|NCT02646709|Drug|ketamine 1|ketamine 1 mg/kg will be injected for induction of anesthesia
16032754|NCT02646709|Drug|ketamine 1.5|ketamine 1.5 mg/kg will be injected for induction of anesthesia
16032755|NCT02646709|Drug|ketamine 2|ketamine 2 mg/kg will be injected for induction of anesthesia
16032756|NCT02646696|Other|Sensory Challenge Protocol|Measurement of electrodermal activity in response to sensation
16032757|NCT02646683|Drug|vedolizumab|
16032758|NCT02646670|Drug|Ranibizumab|- In the first group will be held three applications of intravitreal ranibizumab 0.1 ml, with one application every month and follow up with Optical Coherence Tomography
16032759|NCT02646670|Drug|Aflibercept|- In the second group will be held three applications of Intravitreal Aflibercept 0.1 ml, with one application each month followed by monitoring with Optical Coherence Tomography
16032760|NCT02646670|Drug|Ranibizumab and Aflibercept|- The third group will be held two applications of Ranibizumab 0.1 ml interspersed with one application of Aflibercept 0.1 ml in the second month and subsequent evaluation with Optical Coherence Tomography
16032761|NCT02646670|Drug|Aflibercept and ranibizumab|- In the fourth group will be held two applications of 0.1 ml Aflibercept interspersed with one application of Ranibizumab 0.1 ml in the second month and subsequent evaluation with Optical Coherence Tomography
16032762|NCT02646657|Drug|Vedolizumab 300 mg|Open-label VEDOLIZUMAB 300 mg at week 0,2,6, 14, 22, 30, 38, 46
16032763|NCT02646644|Other|Metastasized intestinal NET|This is an observational study
16032764|NCT02646631|Other|Usual Care|Participants assigned to this treatment will receive the usual care as determined by their physician
16032765|NCT02646631|Behavioral|Management of Risks in Epilepsy (MORE)|MORE is a smartphone application which participants use to record information on a daily basis about seizures (severity, type), medications, and mood and stress levels. It also includes a camera-based application which uses a pill scanner and photo to record the identity and quantity (dose) of medications just prior to them being taken. Also included in the app are medication reminders, educational video clips, and self-management tips.
16032766|NCT02646631|Behavioral|Telephone-based motivational interviewing (MORE+MI)|Participants will receive a total of 4 motivational interviewing sessions over the phone. These sessions last approximately 20 minutes each and build on the educational materials already provided within the MORE app.
16032767|NCT02646631|Other|Educational Materials|Printed educational materials on the management of epilepsy
16032768|NCT02646618|Behavioral|Get Social|Online-delivered weight loss intervention
16032769|NCT02646618|Behavioral|Traditional|Group-delivered weight loss intervention
16032770|NCT02646618|Device|Smartphone|A smartphone is needed to use MyFitnessPal for all participants and to access Twitter for the Get Social participants
16032771|NCT02646605|Other|depression screening|Patient Health Questionnaire
16032772|NCT02646592|Drug|Alfentanil|Bolus of alfentanil 10 µg/kg 5 minutes before skin incision
16032773|NCT02646592|Drug|sevoflurane or propofol|
16032774|NCT02646579|Procedure|Spinal and Peripheral Dry Needling|Participants will be positioned lying flat and the relevant spinal level will be treated using a Seirin L- type 50 mm needle. The needle will be inserted to a depth no greater than three-quarters length of the needle for 30 seconds using a vertical pistoning technique and then statically up to 10 minutes.
16032775|NCT02646579|Procedure|Peripheral Dry Needling|Participants will be positioned lying flat and the relevant peripheral points will be treated using a Seirin L- type 50 mm needle. The peripheral treatment site(s) will be determined by the physical therapist's palpation of active or latent trigger points or tender points. The needle will be inserted to a depth no greater than three-quarters length of the needle for 30 seconds using a vertical pistoning technique and then statically up to 10 minutes.
16032776|NCT02646566|Drug|APD421|
16032777|NCT02646566|Drug|Placebo|
16032778|NCT02646553|Other|Children refered to the obesity clinic|Compere if urine cortisol is as good as saliva cortisol as a screening for hypercortisolism in children.
16032779|NCT02646540|Drug|Tolvaptan 30 mg + IV Diuretics|Participants will receive oral daily tolvaptan 30 mg concomitantly with their standard dose of intravenous (IV) diuretics for the duration of their hospitalization.
16032780|NCT02646540|Drug|Metolazone 5 mg + IV Diuretics|Participants will receive oral daily metolazone 5 mg concomitantly with their standard dose of intravenous (IV) diuretics for the duration of their hospitalization.
16032894|NCT02645760|Other|Conventional treatment|7-weeks of conventional treatment include therapeutic ultrasound and hot pack
16032781|NCT02646540|Drug|2.5 times the Diuretics Dose|Participants will receive two and a half (2.5) times their standard dose of intravenous (IV) diuretics for the duration of their hospitalization.
16032782|NCT02646527|Behavioral|Dignity Therapy|Dignity Therapy (DT) is a brief psychotherapeutic intervention developed by Chochinov (2012) which has been shown to enhance the end of life experience in people with life-limiting conditions. DT focuses on helping patients with terminal illnesses to go over things that are most meaningful to them and document their legacy. Dignity Therapy+ (DT+) involves patient and partner/family asking questions about their most important achievements, roles and other important aspects of life. DT+ encourages patients saying things to loved ones that have remained unsaid. DT+ consists of 3 sessions (1. introduction (30'); 2. main session (60'), 3. final session (30')) and will be conducted by a trained therapist. All therapy session will be audio-taped, transcribed verbatim by the study coordinator, edited by the therapist and returned to the patient or the patient and partner/family as a 'generativity document'.
16032783|NCT02646514|Device|Radiofrequency ablation with stenting|"Side viewing endoscope or PTCS scope can be used for all procedures. Cholangiogram is performed to confirm the stricture location, length and diameter. And then, RF catheter (ELRA®) is advanced over a guide wire at the level of the biliary stricture and ablation at 7-10 watts for a time period of 60-120s according to the length is conducted.
~After performance of RFA, metal stents are inserted to ensure adequate decompression and bile drainage."
16032784|NCT02646514|Device|stenting|Metal stents are inserted to ensure adequate decompression and bile drainage. The diameter and stent lengths can be changed according to the lesion.
16032785|NCT02646501|Drug|Antiarrhythmic drug|Antiarrhythmic drug
16032786|NCT02646501|Procedure|percutaneous stellate ganglion block (PSGB)|percutaneous stellate ganglion block (PSGB)
16032787|NCT02646488|Behavioral|Million Hearts ABCS 6 Months|The ABCS refer to the following: Aspirin in high-risk individuals (A), Blood pressure control and management (B), Cholesterol management (C), and Smoking cessation (S).
16032788|NCT02646488|Behavioral|Million Hearts ABCS 9 Months|The ABCS refer to the following: Aspirin in high-risk individuals (A), Blood pressure control and management (B), Cholesterol management (C), and Smoking cessation (S).
16032789|NCT02646488|Behavioral|Million Hearts ABCS 12 Months|The ABCS refer to the following: Aspirin in high-risk individuals (A), Blood pressure control and management (B), Cholesterol management (C), and Smoking cessation (S).
16032790|NCT02646488|Behavioral|Million Hearts ABCS 15 Months|The ABCS refer to the following: Aspirin in high-risk individuals (A), Blood pressure control and management (B), Cholesterol management (C), and Smoking cessation (S).
16032791|NCT02646488|Behavioral|Standard Care Regimen 9 Months|
16032792|NCT02646488|Behavioral|Standard Care Regimen 12 Months|
16032793|NCT02646488|Behavioral|Standard Care Regimen 15 Months|
16032794|NCT02646488|Behavioral|Standard Care Regimen 18 Months|
16032795|NCT02646488|Behavioral|Standard Care Regimen 21 Months|
16032796|NCT02646488|Behavioral|Standard Care Regimen 24 Months|
16032797|NCT02646488|Behavioral|Standard Care Regimen 27 Months|
16032798|NCT02646488|Behavioral|Follow Up Post Intervention 21 Months|
16032799|NCT02646488|Behavioral|Follow Up Post Intervention 24 Months|
16032800|NCT02646488|Behavioral|Follow Up Post Intervention 27 Months|
16032801|NCT02646488|Behavioral|Follow Up Post Intervention 30 Months|
16032802|NCT02646488|Behavioral|Follow Up Post Intervention 33 Months|
16032803|NCT02646475|Drug|Angiotensin-(1-7)|This is a biologically active endogenous angiotensin peptide. It may play an important role in the regulation of blood pressure by dilating blood vessels as well as a role in the regulation of insulin action.
16032804|NCT02646475|Drug|Saline|Normal saline will be used as a placebo comparator.
16032805|NCT02646449|Drug|Mirtazapine|Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.
16032806|NCT02646449|Drug|Placebo|Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.
16032807|NCT02646436|Other|HD treatment|Patients with absolute contraindication to the PD method will be treated with HD. HD will be performed after implantation of central venous catheter using Seldinger technique by nephrology team.
16032808|NCT02646436|Other|PD treatment|Patients without absolute contraindication to the PD method will be treated with PD. PD will be performed after implantation of peritoneal catheter using Seldinger technique by nephrology team.
16032809|NCT02646423|Behavioral|Prior CD Decision App|The Prior CD Decision App begins with an explanation that its goal is to help the user better understand the two approaches to delivery she is eligible for (trial of labor after cesarean (TOLAC) and elective repeat cesarean delivery (ERCD)), and that its goal is to help her engage with her provide in making an informed, shared decision regarding which approach to undergo. It includes four sections: a calculator to estimate the likelihood of having a vaginal delivery if she undergoes TOLAC, a series of information pages that include graphical presentations of the chances of various potential outcomes of the two options, a series of values clarification exercises to help the user think through what's important to her, and a summary print out for her to keep.
16032810|NCT02646410|Other|FPD+NDOT|
16032811|NCT02646410|Other|FPD+DOT|
16032812|NCT02646410|Other|DDD+NDOT|Door to door delivery + non directly observed treatment
16032813|NCT02646410|Other|DDD+DOT|Door to door delivery + directly observed treatment
16032814|NCT02646397|Drug|Fosinopril|Fosinopril is an angiotensin-converting enzyme inhibitor.
16032815|NCT02646397|Drug|Benidipine|Benidipine is a dihydropyridine-derived calcium channel blocker.
16032816|NCT02646397|Drug|Hydrochlorothiazide|Hydrochlorothiazide is a diuretic medication.
16032817|NCT02646384|Procedure|Ovarian tissue cryopreservation|Ovarian tissue will be removed
16032818|NCT02646371|Biological|Flexyn2a|2 doses of 10 μg of Flexyn2a will be injected intramuscularly 4 weeks apart
16032819|NCT02646371|Biological|Placebo|2 doses of TBS solution will be injected intramuscularly 4 weeks apart
16032820|NCT02646358|Drug|Vepoloxamer|
16032821|NCT02646345|Procedure|Surgical checklist|Use of the World Health Organization Surgical checklist
16033019|NCT02644967|Drug|Ipilimumab|4 doses administered intravenously at a dose of 3 mg/kg over 90 minutes on Weeks 2, 5, 8, and 11.
16032822|NCT02646332|Drug|(dexlan+amox+clar+metr)+(dexlan+amox)|a 7-day quadruple regimen with dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with dexlansoprazole MR 60 mg once daily and amoxicillin 1 g twice daily
16032823|NCT02646332|Drug|dexlan+clarith+amox+metro|dexlansoprazole MR 60 mg once daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily for 14 days
16032824|NCT02646319|Other|Laboratory Biomarker Analysis|Correlative studies
16032825|NCT02646319|Drug|Nanoparticle Albumin-Bound Rapamycin|Given IV
16032826|NCT02646319|Other|Quality-of-Life Assessment|Ancillary studies
16032827|NCT02646306|Other|shoulder proprioceptive rehabilitation tool|"Using of this tool to measure which is the average error in reaching back in both healthy subjects and subjects with shoulder impingement syndrome starting from the assumption that the shoulder, through the articulation scapulothoracic, helps to determine direction and distance during the reaching of an object."
16032828|NCT02646280|Other|Massage therapy|Massage therapy as a treatment option to induce a relaxation and a reduction of pain and stress in patients affected by chronic low back pain.
16032829|NCT02646280|Other|Neurocognitive rehabilitation|Provided through the association of motor imagery and the words of the physiotherapist with the aim of increasing the effectiveness of massage in reducing pain.
16032830|NCT02646267|Drug|standard intensity warfarin|target international normalised ratio(INR) was 2.1-3.0
16032831|NCT02646267|Drug|low intensity warfarin|target international normalised ratio(INR) was 1.7-2.2
16032832|NCT02646267|Drug|dabigatran etexilate|110mg, twice a day, oral
16032833|NCT02646254|Other|blood cardioplegia|
16032834|NCT02646254|Other|del nido cardioplegia|
16032835|NCT02646241|Procedure|unroofing biopsy|Unroofing biopsy menas that the mucosa is resected with endoscopic mucosal resection and biopsies are done repeatedly for the exposed tumor with a conventional forcep. It will be performed for the patients with a suspected upper gastrointestinal subepithelial tumor after EUS-FNB. After unroofing biopsy, the final histopathological result will be used to determine diagnostic accuracy.
16032836|NCT02646241|Procedure|EUS-FNB(endoscopic ultrasonography guided fine needle biopsy)|EUS-FNB will be performed for the same patients who have a gastrointestinal subepithelail tumor before unroofing biopsy. EUS-FNB is called when the tissue is obtained by puncutre of a tumor, the tissue whithin the lumen of the fine needle being detached by rotatin, and the needle withdrawn. The pathological result will be also used to compare diagnostic accuracy between EUS-FNB & unroofing biopsy.
16032837|NCT02646228|Other|molecular profiling, patient derived cells|"molecular profiling,patient derived cells sample and experimental methods-Blood sample,tumor tissue or primary cultures of human effusions.
~Malignant ascites, pleural effusions, or pericardial effusions will be collected from patients with metastatic cancer."
16032838|NCT02646215|Device|Threshold inspiratory muscle training|Inspiratory muscle training
16032839|NCT02646202|Procedure|Sclerotherapy|Injection of varices
16032840|NCT02646202|Procedure|Band ligation|endoscopic banding of varices
16032841|NCT02646202|Procedure|Scleroligation|intra variceal endoscopic sclerotherapy combined with band ligation.
16032842|NCT02646189|Drug|REP 2139-Ca|REP 2139-Ca is administered weekly at 250 or 500mg doses by slow IV infusion.
16032843|NCT02646189|Drug|Zadaxin|Zadaxin is administered twice weekly (1.6mg) by subcutaneous injection
16032844|NCT02646189|Drug|Pegasys|Pegasys in administered once weekly by subcutaneous injection with dose escalation to 180ug / week.
16032846|NCT02646163|Drug|REP 2055|"(First two patients) REP 2055 is administered once weekly by slow IV infusion in dose escalation from 100 to 1200mg until a grade 3 adverse event is observed not to exceed 40 weeks of dosing.
~(Subsequent patients) 400mg of REP 2055 is administered by slow IV infusion. First week of infusion to include daily dosing followed by twice weekly dosing for 40 weeks."
16032847|NCT02646150|Procedure|Magnetic Resonance Perfusion Imaging|
16032848|NCT02646137|Drug|Transarterial chemoembolization (TACE)|TACE exploits the preferential hepatic arterial supply of liver tumors for targeted delivery of chemotherapeutic agents followed by embolization or reduction in arterial flow using various types of particles
16032849|NCT02646137|Procedure|Radiofrequency ablation combined with TACE|Radiofrequency ablation (RFA) is an alternative therapy for HCC and liver metastases that can destroy a tumor by inducing thermal injury to the tissue through electromagnetic energy deposition
16032850|NCT02646137|Procedure|Microwave ablation combined with TACE|Microwave ablation (MWA) is an appealing alternative therapy for HCC in which a microwave antenna is placed directly into the tumor, emitting an electromagnetic wave which agitates water molecules in the surrounding tissue, producing friction and heat, thereby inducing cell death via coagulation necrosis
16032851|NCT02646124|Drug|Naproxen|Naproxen 500mg by mouth two times a day, #20
16032852|NCT02646124|Drug|Placebo|28 placebo capsules
16032853|NCT02646124|Drug|Diazepam|Diazepam 5mg capsules, 1-2 tabs by mouth two times a day, #28
16032854|NCT02646111|Drug|12 weeks without Ribavirin|12 weeks Triple Therapy: Ombitasvir, Paritaprevir, Ritonavir (25/150/100 mg dose) once daily and Dasabuvir 250 mg twice daily.
16032855|NCT02646111|Drug|12 weeks with Ribavirin|12 weeks Triple Therapy: Ombitasvir, Paritaprevir, Ritonavir 25/150/100 mg dose once daily + Dasabuvir 250 mg twice daily + weight adjusted Ribavirin, daily dose: 1,000 mg weight <75 kg, 1,200 mg weight> 75 kg.
16032856|NCT02646111|Drug|24 weeks with Ribavirin|24 weeks Triple Therapy: Ombitasvir, Paritaprevir, Ritonavir 25/150/100 mg dose once daily + Dasabuvir 250 mg twice daily + weight adjusted Ribavirin, daily dose: 1,000 mg weight <75 kg, 1,200 mg weight> 75 kg.
16032857|NCT02646098|Procedure|CD34+ cell selection|CD34+ cell selection applying a CliniMACS device (Miltenyi Biotec, Bergisch Gladbach, Germany). This method for CD34+ cell selection will be used in this study and is considered as the standard treatment.
16032858|NCT02646085|Drug|C11 Methionine positron emission tomography|diagnostic positron emission tomography imaging after intravenous injection of C11 Methionine
16032859|NCT02646072|Drug|Ketorolac tromethamine ophthalmic solution 0.45%|Indicated for the treatment of pain and inflammation following cataract surgery.
16033159|NCT02644083|Drug|Dimethyl fumarate|
16032860|NCT02646059|Other|Text message|Text messages would be sent via the messaging platform of Guangzhou Blood Center. The feedback of sending status (received, failed to receive, or unknown) would be marked on every number. Four to six months follow-up, blood donation rate would be checked.
16032861|NCT02646059|Other|Telephone|Status (response, no answer, line issue, wrong number or refused to be interviewed) of every donor in this groups would be marked. Four to six months follow-up, blood donation rate would be checked.
16032862|NCT02646046|Behavioral|Combi lone-CPR|When study participants meet the arrest victim (simulated), they start chest compression and call for help to EMS at the same time, then continue the chest compression and 2 breath alternatively until the EMS arrival
16032863|NCT02646046|Behavioral|Conventional lone-CPR|When study participants meet the arrest victim (simulated), they first call for help to EMS and then start chest compression and 2 breath alternatively until the EMS arrival
16032864|NCT02646020|Drug|Aprepitant|aprepitant 125mg d1, 80mg d3 and d5; until pruritus recurrence or discontinuation of EGFR-TKI or safely issues (SAE etc.)
16032865|NCT02646020|Drug|Desloratadine|Desloratadine 5mg d1-d28; until pruritus recurrence or discontinuation of EGFR-TKI or safely issues (SAE etc.)
16032866|NCT02646020|Drug|Placebo of aprepitant|Placebo of aprepitant 125mg d1, 80mg d3 and d5; until pruritus recurrence or discontinuation of EGFR-TKI or safely issues (SAE etc.)
16032867|NCT02646020|Drug|Placebo of desloratadine|Placebo of desloratadine 5mg d1-d28; until pruritus recurrence or discontinuation of EGFR-TKI or safely issues (SAE etc.)
16032868|NCT02646007|Biological|BM-MSC transplantation|Transplantation of bone marrow derived mesenchymal stem/ stromal cells in combination with bone decompression surgery in Kienböck's disease.
16032869|NCT02645994|Device|Target Controlled Infusion|Used to control intravenous propofol delivery with target plasma concentratioins changed manually
16032870|NCT02645994|Device|Closed Loop Anesthesia Delivery System|Used to deliver propofol automatically titrated to achieve a target BIS 50, and maintain it between 40 and 60.
16032871|NCT02645981|Drug|Donafenib|Donafenib is an oral multikinase inhibitor with antiproliferative and antiangiogenic effects
16032872|NCT02645981|Drug|Sorafenib|Control
16032873|NCT02645942|Dietary Supplement|L-carnitine|L-carnitine 1400 mg daily for 8 weeks
16032874|NCT02645942|Dietary Supplement|Placebo|Placebo daily for 8 weeks
16032875|NCT02645929|Behavioral|Interpersonal Psychotherapy (IPT)|IPT is a 14 week psychotherapy for PTSD. SSRF is a brief interview to assess emotional understanding of one's symptoms.
16032876|NCT02645916|Drug|Danggui-Sayuk-Ga-Osuyu-Saenggang-tang|Usage: 3g, three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
16032877|NCT02645916|Drug|Placebo: corn starch|Usage: 3g three times a day, each taken before or between meals Manufacturing company: HANPOONG PHARM & FOODS Co. Ltd.
16032878|NCT02645903|Drug|Transversus Abdominis Plane Block|Cases to whom used bupivacaine with ultrasound guided transversus abdominis plane block was applied after standard general anesthesia were determined as Group 1
16032879|NCT02645903|Drug|standard general anesthesia|Cases to whom applied alone standard general anesthesia were determined as Group 2
16032880|NCT02645890|Drug|CKD-397|Arm A:Tamsulosin/ Tadalafil Fixed dose combination
16032881|NCT02645890|Drug|TD+TM|Arm B: Tamsulosin/ Tadalafil Coadministration
16032882|NCT02645877|Procedure|Prehospital care|The common cause of pre-hospital care demands were Abdominal Problems, Allergies/Envenomation, Animal Bites, Assault/Sexual, Back Pain, Breathing Problems, Burns/Explosions, Carbon Monoxide/Inhalation/Radiation/Hazardous Material, Cardiac or Respiratory Arrest, Chest Pain, Choking, Convulsions/Seizures, Diabetic Problems, Drowning/Diving/Scuba Accident, Electrocution/Lightning, Eye Problems/Injuries, Falls, Headache, Heart Problems, Heat/Cold Exposure, Hemorrhage/Lacerations, Inaccessible Incident/Entrapments, Overdose/Poisoning, Pregnancy/Childbirth/Miscarriage, Psychiatric/Suicide Attempt, Sick Person, Stabbing/Gunshot/Penetrating Trauma, Stroke, Traffic Injuries, Traumatic Injuries, Unconscious/Fainting, Unknown Problems, Inter-Facility Transfer/Palliative Care, Flu-Like Symptoms, etc.
16032883|NCT02645864|Drug|Apatinib|250mg p.o. qd in first cohort (3 subjects). 250mg p.o. bid in second cohort (3 subjects) 250mg p.o. tid in third cohort (3 subjects)
16032884|NCT02645864|Drug|Irinotecan|150mg/m^2 i.v. q2w
16032885|NCT02645851|Drug|fluid bolus|Administration of the fluid bolus if deemed clinically necessary, OR if deemed clinically necessary AND PLR-induced SV or PP changes ≥10%, depending of the Arm the patient is assigned to
16032886|NCT02645851|Device|PiCCO system (Pulsion, Germany)|During the intervention period (from inclusion to the 120th hour), every time a fluid bolus is deemed necessary, fluid responsiveness will be assessed by Stroke Volume changes obtained at 1 min of a Passive Leg Raising (PLR) test (fluid will be given if PLR-induced stroke volume change is over 10%; in case stroke volume change is below 10%, fluid will not be given and need for fluid reassessed after a short period of time, as in usual care)
16032887|NCT02645851|Device|Vascular pressure transducers (Edwards Life Science, USA)|During the intervention period (from inclusion to the 120th hour), every time a fluid bolus is deemed necessary, fluid responsiveness will be assessed by Pulse Pressure changes obtained at 1 min of a Passive Leg Raising (PLR) test (fluid will be given if PLR-induced Pulse Pressure change is over 10%; in case Pulse Pressure change is below 10%, fluid will not be given and need for fluid reassessed after a short period of time, as in usual care)
16032888|NCT02645851|Other|Passive Leg Raising test|Passive elevation of the legs of the patient, and lying down of the trunk (if patient is in the semi-recumbent position), preferably using electric bed. If not available, elevation of the legs by an assistant to a 45 degrees angle. Effects of Passive Leg Raising on Pulse Pressure or on Stroke Volume are used to assess fluid responsiveness in patients suffering from shock states.
16032889|NCT02645838|Behavioral|Motivational interviewing|1. Structural motivational interviewing for one section (about 20 mins)，provided by family physician;2. Follow-up telephone call，provided by family physician.
16032890|NCT02645799|Drug|LABR-312|administered intravenously at the time of percutaneous coronary intervention (PCI) with a drug eluting stent
16032891|NCT02645799|Drug|Saline (placebo)|administered intravenously at the time of percutaneous coronary intervention (PCI) with a drug eluting stent
16032892|NCT02645773|Device|non-ablative laser|non-abaltive laser pre, immediate and post wounding
16032893|NCT02645760|Other|Core stabilization exercise|7-weeks of core stabilization exercise
16035341|NCT02628496|Procedure|Biopsy (standard of care)|
16032895|NCT02645747|Drug|Aflibercept (Eylea, BAY86-5321)|"Eylea (intravitreal aflibercept) is an anti-Vascular Endothelial Growth Factor (VEGF) drug indicated for neovascular age-related macular degeneration (AMD), visual impairment due to diabetic macular edema (DME) and visual impairment due to macular edema (ME) secondary to central or branched retinal vein occlusion (RVO).
~RVO, both branch and central, is the second most common type of retinal vascular disorders after diabetic retinal disease. Central retinal vein occlusion (CRVO) is characterized by an obstruction of the central retinal vein combined with variable amounts of retinal arterial insufficiency."
16032896|NCT02645734|Drug|bevacizumab|1.25 mg of bevacizumab is injected
16032897|NCT02645734|Drug|ziv-aflibercept 1.25 mg|1.25 mg of ziv-aflibercept is injected
16032898|NCT02645734|Drug|ziv-aflibercept 2.5mg|2.5 mg of ziv-aflibercept is injected
16032899|NCT02645721|Behavioral|Extended self-help program with guidance|See arm description for Experimental
16032900|NCT02645721|Behavioral|Briefer Self-help program, no guidance|See arm description for Active Comparator
16032901|NCT02645721|Behavioral|WL: Extended self-help program, choice of guidance intensity|See arm description for Waiting list.
16032902|NCT02645708|Procedure|Retrograde Intrarenal Surgery|Patients undergo Retrograde Intrarenal Surgery
16032903|NCT02645708|Procedure|EPVL after RIRS|Patients in Group 2 undergo EPVL after RIRS
16032904|NCT02645695|Device|routine pulmonary rehabilitation|received routine pulmonary rehabilitation consisted of position giving technique (left lateral, supine, right lateral), chest wall percussion, postural drainage and airway aspiration at every 3 hours.
16032905|NCT02645695|Device|chest wall vibration technique|administered chest wall vibration technique in addition to the routine pulmonary rehabilitation method for 72 hours. Chest vibration method was applied with 7-10 hz frequency given by a ped wrapped around the thorax and pulmonary rehabilitation with 3 mmHg pressure four times a day with 15-minute periods (TheVest® Model 205).
16032906|NCT02645682|Device|anti-infection CVC|
16032907|NCT02645682|Device|normal CVC|
16032908|NCT02645669|Procedure|Study site|The probiotic is in the form of a lyophilized powder containing approximately 5 billion colony forming units (CFU) of the Saccharomyces boulardii. At the time of administration, the probiotic mixture was mixed with fructooligosaccharide in the ratio of 4:1 to induce growth and activity in S boulardii. This was applied after scaling and root planing.
16032909|NCT02645669|Procedure|Control site|Only Scaling and Root planing was done.
16032910|NCT02645656|Drug|Curcumin Arm|Curcumin gel will be applied in sites with Oral Submucous Fibrosis at designated time intervals
16032911|NCT02645643|Other|Education of medical humanities|The medical students in the intervention group would gain education about the medical humanities, but not the control group.
16032912|NCT02645630|Other|Right Cervical Manipulation|We will use a high-velocity, mid-range, left rotational force to the right articular pillar of C3, on the right articular pillar of C4 with the patient in supine, with left rotation and right side-bending.
16032913|NCT02645630|Other|Left Cervical Manipulation|We will use a high-velocity, mid-range, left rotational force to the left articular pillar of C3, on the left articular pillar of C4 with the patient in supine, with right rotation and left side-bending.
16032914|NCT02645630|Other|Sham Cervical Manipulation|The sham procedure will simulate C3/C4 manipulation in both sides without any therapeutic thrust
16032915|NCT02645617|Drug|Varnish|Topical application to the teeth
16032916|NCT02645591|Procedure|Robotic Assisted Laparoscopic Radical Prostatectomy (RARP)|Participants receive Nerve Sparing robotic assisted laparoscopic radical prostatectomy (RARP).
16032917|NCT02645591|Biological|AmnioFix®|Dehydrated human amnion/chorion membrane (dHACM) wrapped around the nerve bundles at the end of Nerve Sparing robotic assisted laparoscopic radical prostatectomy (RARP) surgery.
16032918|NCT02645591|Behavioral|Questionnaire|Questionnaire completed about erectile function before surgery, and at 6 weeks, 3 months, 6 months, and 12 months after surgery.
16032919|NCT02645578|Device|Right median nerve stimulation|Right median nerve electrical stimulation (RMNS) is administered via a pair of lubricated one-inch square rubber surface electrodes pasted on the volar aspect of the right distal forearm over the median nerve. An electrical neuromuscular stimulator supplied trains of asymmetric biphasic pluses at an amplitude of 20 milliamps with a pulse width of 300 microseconds at 40 Hz for 20 sec/min. The RMNS treatment continues 8 hours per day for two weeks.
16032920|NCT02645565|Drug|Cyclophosphamide|Cyclophosphamide is an alkylating agent used for the treatment of lupus nephritis.
16032921|NCT02645565|Drug|Azathioprine|azathioprine will be given at 2 mg/kg.
16032922|NCT02645565|Drug|Methylprednisolone|Each treatment arm shall receive 1 gm methylprednisolone pulse for 3 days followed by prednisolone 1 mg/kg for 4 weeks and tapered 5 mg every 2 weekly ,to maintain 7.5 mg dose daily
16032923|NCT02645552|Drug|Tranexamic Acid|Tranexamic acid 1 gram in 100 ml saline, by intravenous drip over 10 minutes, once patient admitted to the trial on the spot of TBI
16032924|NCT02645552|Other|Sodium chloride|Sodium Chloride solution (0.9%) 1 ml (gram) in 100 ml saline, by intravenous drip over 10 minutes, once patient admitted to the trial on the spot of TBI
16032925|NCT02645539|Device|intravascular ventricular assist system (iVAS)|A mechanical circulatory support device using the principles of counterpulsation.
16032926|NCT02645526|Other|Woolen cap|
16032927|NCT02645513|Behavioral|Malaria text message reminders to health workers|Text message reminders contain key details from national case management guidelines on diagnosis and treatment of malaria
16032928|NCT02645513|Behavioral|Malaria, pneumonia, and diarrhea text message reminders to health workers|Text message reminders contain key details from national case management guidelines on diagnosis and treatment of malaria, pneumonia, and diarrhea
16032929|NCT02645513|Behavioral|Control|No text message reminders
16032930|NCT02645500|Behavioral|Holistic health training and physical exercise messages|The physical activity message arm includes a training workshop in relation to holistic health, and daily physical activity messages.
16032931|NCT02645500|Behavioral|Holistic Health Training with healthy diet messages|The healthy diet message arm includes a training workshop in relation to holistic health, and daily healthy diet messages.
16032932|NCT02645487|Radiation|Stereotactic Radiosurgery|Radiation, Stereotactic Radiosurgery Size <= 1cm: 24 Gray (Gy); + 3 Gy incremental escalation up to 30 Gy >1-2cm: 21 Gy; + 3 Gy incremental escalation up to 27 Gy >2-3cm: 18 Gy; + 3 Gy incremental escalation up to 24 Gy
16032933|NCT02645474|Procedure|PECS block with ropivacaine|Local anesthetic (ropivacaine 0.5%, total volume 30 ml) is infiltrated in between the fasciae of serratus and minor pectoralis muscles under ultrasound guidance.
16032934|NCT02645474|Procedure|Paravertebral block with ropivacaine|Local anesthetic (ropivacaine 0.5%, total volume 20 ml) is infiltrated in the paravertebral block at T4 level under ultrasound guidance.
16032935|NCT02645474|Drug|Ropivacaine|Amidic local anesthetic standardly used for nerve block and infiltration
16032936|NCT02645461|Drug|endocannabinoid palmitoylethanolamide (PEA)|Endocannabinoid palmitoylethanolamide (PEA) (ultramicronized) 600 mg twice daily
16032937|NCT02645461|Drug|Riluzole|Riluzole 50 mg twice daily
16032938|NCT02645448|Other|Resistance Exercise|"Control Session
~Resistance exercise at different intensities (40%1RM or 80%1RM)
~Duration of effect"
16032939|NCT02645435|Procedure|hip replacement|Total hip replacement
16032940|NCT02645409|Drug|OTL38|OTL38 is a folate analog conjugated with a fluorescent dye that emits light in the near infrared spectrum. This longer wavelength allows for deeper penetration of the fluorescent light through tissues with the potential to better image tumors beneath adipose tissue or deeper into organ parenchyma.
16032941|NCT02645409|Device|Intraoperative fluorescence imaging system|
16032942|NCT02645383|Device|PASCAL laser|A novel semi-automatic and multi-shot photocoagulator called as PASCAL (Pattern scan laser, Opti-Medica Corp., Santa Clara, California, USA) was introduced with a reduction in pulse duration of each laser spot from typical 100 ms down to 10-30 millisecond. Compared with the conventional laser, shorter pulses have been shown to significantly reduce the risk of damage to the adjacent retinal tissues. One eye was treated with PASCAL laser, the other was treated with conventional laser with 30 minutes resting intervals. To avoid a bias about orientation or becoming accustomed to laser procedure, PASCAL laser was performed in the first eyes in half of the patients (14 patients) randomly.
16032943|NCT02645383|Device|Conventional laser|Maintaining of good glycemic regulation and performing panretinal laser photocoagulation (PRP) with conventional laser device (ELLEX Integre, Adailade, Australia) when it is indicated are evidence based effective methods for proliferative diabetic retinopathy.One eye was treated with conventional laser, the other was treated with PASCAL laser with 30 minutes resting intervals. To avoid a bias about orientation or becoming accustomed to laser procedure, conventional laser was performed in the first eyes in half of the patients (14 patients) randomly.
16032944|NCT02645370|Drug|Danzhen|
16032945|NCT02645370|Drug|Topiramate|
16032946|NCT02645357|Other|computer reminders on clinical practice|on-screen, point-of-care computer reminders on clinical practice.
16032947|NCT02645357|Other|Control group|control group
16032948|NCT02645344|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|
16032949|NCT02645344|Behavioral|Sensory Cueing (SC)|
16032950|NCT02645344|Behavioral|Conventional Rehabilitation|
16032951|NCT02645331|Behavioral|Remind-to-move|
16032952|NCT02645331|Behavioral|Modified constraint induced movement therapy|
16032953|NCT02645331|Behavioral|Conventional rehabilitation|
16032954|NCT02645305|Biological|Adipose derived stem cells|Adipose derived stem cells that are isolated from adipose tissue are mesenchymal stem cells with high immune modulation capacity. Therefore, they can effectively modulate the immune system.
16032955|NCT02645292|Device|1 mile walk using treadmill|Walk for 1 mile on treadmill (American Motion Fitness, 8800D) at self selected speed as fast as participant can without any inclination.
16032956|NCT02645292|Device|Stair Climbing|Climb 14 flights of stairs at self selected speed. No double step at a time and running allowed.
16032957|NCT02645279|Other|oral 30% glucose|30% glucose solution was administered orally through a teat. 1 mL 30% glucose solution was added following placement of the teat into the mouth of the newborn. After suckling of 0.5-1 mL glucose solution, the motionless and sleepiness of newborn was evaluated. If the target conditions was not achieved, 0.5-1 mL increments of glucose was added until the newborn kept motionless or asleep.
16032958|NCT02645279|Drug|IV midazolam|IV 0.1 mg/kg midazolam was administered.MRI was routinely performed and the newborns who did not keep motionless or asleep and had motion artefacts were sedated with intravenous 0.5 mg/kg propofol.
16032959|NCT02645266|Drug|Aflibercept Injection [Eylea]|Subjects will be administered 2.0mg Aflibercept intraocular injection each month for 5 consecutive months. After the 5th month, the serum cytokine levels in blood work will be assessed as well as patients's visual acuity, and eye pressures. Upon completion of the trial, patients will resume receiving the usual standard of care.
16032960|NCT02645253|Drug|AZD7594 inhalation powder (200 μg)|200 μg AZD7594 inhalation powder via multi-dose dry powder inhaler (DPI)
16032961|NCT02645253|Drug|AZD7594 inhalation powder (400 μg)|Cohort 2: 400 μg AZD7594 inhalation powder via multi-dose DPI Cohort 3: 1600 μg (4 x 400 μg inhalations) AZD7594 inhalation powder via multi-dose DPI
16032962|NCT02645253|Drug|AZD7594 pressurized inhalation suspension (200 μg)|400 μg (2 x 200 μg inhalations) AZD7594 pressurized inhalation suspension via pressurized metered dose inhaler (pMDI)
16032963|NCT02645253|Drug|AZD7594 placebo inhalation powder|AZD7594 placebo inhalation powder via multi-dose DPI
16032964|NCT02645253|Drug|AZD7594 placebo pressurized inhalation suspension|AZD7594 placebo pressurized inhalation suspension via pressurized metered dose inhaler (pMDI)
16032965|NCT02645240|Drug|Heparin injection|Intravenous heparin injection in patients with acute mesenteric ischemia and evaluating their response within 24 hours
16032966|NCT02645227|Procedure|Open flap debridement (OFD)|Oral prophylaxis followed by OFD for treating bone defect
16032967|NCT02645227|Procedure|OFD with Platelet rich fibrin (PRF)|Oral prophylaxis followed by OFD with PRF placement into the bone defect
16032968|NCT02645227|Procedure|OFD with PRF and 1.2% Rosuvastatin|Oral prophylaxis followed by OFD with PRF and 1.2% Rosuvastatin placement into the bone defect
16032969|NCT02645214|Other|Non-antiseptic scrubs|
16032970|NCT02645214|Other|Antiseptic scrubs|
16032971|NCT02645201|Dietary Supplement|Gastrus|to compare Gastrus 4x108 tbl twice a day to placebo tbl
16032972|NCT02645201|Other|Placebo|to compare Gastrus 4x108 tbl twice a day to placebo tbl
16032973|NCT02645188|Other|Cueing|Verbal and tactile cueing to enhance gluteus maximus recruitment
16032974|NCT02645175|Dietary Supplement|TW1025|20ml, 3 times per day (daily dose: 60 ml)
16032975|NCT02645175|Dietary Supplement|Placebo|20ml, 3 times per day (daily dose: 60 ml)
16032976|NCT02645162|Behavioral|Community-based Preschool|"Preschool sessions in community-based preschool
~Run by trained community youth leaders from the same village."
16032977|NCT02645149|Drug|Standard therapy or clinical trial|Patients with BRAF V600 and NRAS mutations detected by standard of care tumour testing will be treated with standard approved therapies or on clinical trials.
16032978|NCT02645149|Drug|Matched targeted therapy|Patients with tumour found to be BRAF and NRAS wild type will have tumour tested further using the extended molecular testing platform designed for this project. Patients will first receive standard therapy(ies) for BRAF / NRAS wild type melanoma until disease progression or intolerable drug toxicities. Followed by a targeted therapy matched to the genetic aberration detected in their tumour as listed above.
16032979|NCT02645149|Drug|Trametinib and / or supportive care|Patients with BRAF and NRAS wild type tumour for whom there is no actionable genetic aberration in tumour tissue or no available matched targeted therapy following extended molecular testing, may receive trametinib (if not already administered as part of standard care) and/or supportive care.
16032980|NCT02645149|Drug|CDK4/6 and MEK inhibitor|Patients with BRAF and NRAS wild type mucosal melanoma and any genetic aberration may receive ribociclib + trametinib
16032981|NCT02645136|Other|Pilates|Pilates exercises
16032982|NCT02645136|Other|PFMT and AES|conventional pelvic floor muscle exercises combined with anal electrical stimulation Device: electrical stimulation (Dualpex 961 Uro®)
16032983|NCT02645136|Other|Control|
16032984|NCT02645123|Device|TENS|Enraf-Nonius Sonopuls 692
16032985|NCT02645123|Procedure|spinal mobilization|passive physiological intervertebral movements and passive accessory posteroanterior mobilization
16032986|NCT02645123|Procedure|swedish type massage|petrissage, effleurage, tapotement
16032987|NCT02645123|Procedure|static hamstring stretch|static hamstring stretching
16032988|NCT02645123|Procedure|sham treatment|touching of the skin overlying the lumbar area
16032989|NCT02645110|Device|MC Hand Soap|Washing hand with soap in comparison to hand washing with water alone
16032990|NCT02645110|Device|Tap water|Washing hand with water alone in comparison to hand washing with soap
16032991|NCT02645097|Procedure|Saphenous Nerve Block|A nerve block will be performed by the anesthesiologist. The location of the nerve block will be per randomization envelope (proximal vs. distal) and performed just prior to foot or ankle surgical procedures that require a saphenous nerve block
16032992|NCT02645084|Other|Offering an online risk assessment questionnaire|Offering an online risk assessment questionnaire to CRC patients, to facilitate the detection of colorectal cancer patients with hereditary or familial colorectal cancer
16032993|NCT02645071|Behavioral|Physical Activity|A brief education program in reducing sedentary behavior and promoting physical exercise with family would be conducted. Assessments will be conducted in two different time points, before training session (T1), immediately following training (T2) and two weeks after training (T3) to evaluate the effectiveness of training program.
16032994|NCT02645058|Procedure|RIRS|Treatment by ureterorenoscopy (RIRS) and laser lithotripsy
16032995|NCT02645058|Procedure|ESWL|Treatment by extracorporeal shock waves lithotripsy
16032996|NCT02645058|Device|Rigid and flexible ureteroscope|
16032997|NCT02645058|Device|Lithotripter|
16032998|NCT02645058|Device|Holmium laser|
16032999|NCT02645058|Device|Basket for fragment removal|
16033000|NCT02645058|Procedure|General or spinal anesthesia|
16033001|NCT02645058|Drug|Intravenous pain medication|If required by the patient
16033002|NCT02645058|Device|X-ray|To focus the stone
16033003|NCT02645058|Device|Ultrasound|To focus the stone
16033004|NCT02645032|Biological|Vi-DT|Manufacturer: SK Chemicals Co., Ltd. Ingredient: Purified Vi-polysaccharide conjugated to diphtheria toxoid Dose: 0.5 mL/Vial
16033005|NCT02645032|Biological|Typhim Vi®|Manufacturer: Sanofi Pasteur Ingredient: Purified Vi-polysaccharide Appearance: colourless liquid Dose: 0.5mL/vial
16033006|NCT02645032|Biological|VAXIGRIP®|"Dose: Single injection, participants 6-35 months of age will receive 0.25 ml (half a dose), participants 36 months of age and older will receive 0.5ml (full dose)
~*Participants less than 9 years of age, who have not been vaccinated for flu before, will receive a second dose of flu-vaccine after the last follow-up visit of last participant in their age cohort."
16033007|NCT02645019|Device|Cuffed ETT|Cuffed endotracheal tube.
16033008|NCT02645019|Device|Cuffed LMA|Cuffed laryngeal mask airway.
16033009|NCT02645006|Behavioral|3 session workshop|The intervention group will attend a three session workshop, will learn to recognize their risk factors for fall, will be encouraged to adopt a healthy diet (vitamin D consumption), modify home hazards , and increase physical activity (a strength and balance program at home and a group walking route). After a monthly telephone follow-up they are invited to attend a recall session, were they realize the change in the strength and balance tests results.
16033010|NCT02645006|Behavioral|1 session workshop|The control group will attend a single workshop session summarizing the major points of prevention of falls ( risk factors of fall, healthy diet and vitamin D consumption, home hazards, physical activity). After a monthly telephone follow-up they are invited to attend the three session workshop for further prevention.
16033011|NCT02644993|Radiation|Proton therapy|
16033012|NCT02644980|Drug|Propofol|The initiate drug concentration of propofol is set to 1.0 μg/ml, increasing 0.3 μg/ml every minutes until the BIS(Bispectral index ) reaches 40~60.
16033013|NCT02644980|Drug|Etomidate|The initiate drug concentration of etomidate is set to 0.2 μg/ml, increasing 0.1 μg/ml every minutes until the BIS(Bispectral index ) reaches 40~60.
16033014|NCT02644980|Device|Bispectral Index Monitor|BIS monitored from beginning of anesthesia induction to the end of the surgery.
16033015|NCT02644980|Drug|Induction of anesthesia|Midazolam 0.03 mg/kg injection vein，Sufentanyl 0.5~1 μg/kg, target controlled infusion of etomidate or propofol,after the consciousness of patients is lost, rocuronium 0.6mg/kg is given.
16033016|NCT02644980|Drug|Maintenance of anesthesia|After the intubation, target controlled infusion(TCI) of etomidate or propofol is maintained,rocuronium 0.15mg/kg and sufentanil is given when needed. When the operation is over, the TCI is stopped.
16033017|NCT02644980|Other|Tracheal Intubation|After the induction of anesthesia, Tracheal intubation is performed.
16033018|NCT02644967|Drug|IMO-2125|Drug: IMO-2125 Intratumoral injection administered as 9 doses on Weeks 1, 2, 3, 5, 8, 11, 17, 23, and 29.
16033020|NCT02644967|Drug|Pembrolizumab|Drug: Pembrolizumab Administered intravenously at a dose of 200 mg over 30 minutes every 3 weeks beginning on Week 2.
16033021|NCT02644954|Drug|Metformin|Metformin 850 mg twice daily given in the intervention arm to patients of moderate psoriasis
16033022|NCT02644954|Drug|Placebo|Placebo drug twice daily given in the intervention arm to patients of moderate psoriasis
16033023|NCT02644954|Drug|Topical Coal tar|Topical coal tar to be applied once daily
16033024|NCT02644954|Drug|Topical calcipotriol|Topical calcipotriol to be applied once daily
16033025|NCT02644941|Biological|Human Acellular Vessel (HAV)|Surgical implantation of the HAV and subsequent use of the implanted vascular conduit for hemodialysis vascular access.
16033026|NCT02644941|Device|ePTFE graft|Surgical implantation of a commercially available ePTFE graft and subsequent use of the implanted vascular conduit for hemodialysis vascular access.
16033027|NCT02644915|Drug|Edaravone|Edaravone 30mg dissolved in 0.9%NaCl 100ml will be treated at 10 minutes before kidney reperfusion , ending in 30 minutes.The number of dialysis and the serum creatinine level within the first week after the transplantation will be recorded.The participation of each patient is scheduled for 1 month.
16033028|NCT02644915|Drug|0.9%%NaCl solution|"100ml 0.9%%NaCl solution,but without edaravone ,will be treated at 10 minutes before kidney reperfusion , ending in 30 minutes.
~Standard anaesthesia and standard cure are given for all patients. During the operation we maintain the target blood pressure by keeping Central Venous Pressure(CVP)> 6 mmHg"
16033029|NCT02644902|Other|Avatar assisted cascade training|Training of health workers in THP through tablets including avatar characters , and cascaded supervision model.
16033030|NCT02644902|Other|Specialist led training in THP|Training and supervision of lady health workers by specialists as in original THP
16033031|NCT02644876|Drug|Penehyclidine inhalation|Penehyclidine inhalation will be administered by inhalation (penehyclidine hydrochloride 0.5 mg/0.5 ml, mixed with normal saline 5.5 ml) once every 12 hours from the night before surgery till the second day after surgery. The total number of inhalation is seven times. Study drug inhalation is performed with the high-flow oxygen-driven method for the non-intubated patients or with the atomizing inhalation device of ventilator for the intubated patients.
16033032|NCT02644876|Drug|Placebo inhalation|Placebo inhalation will be administered by inhalation (water for injection 0.5 ml, mixed with normal saline 5.5 ml) once every 12 hours from the night before surgery till the second day after surgery. The total number of inhalation is seven times. Study drug inhalation is performed with the high-flow oxygen-driven method for the non-intubated patients or with the atomizing inhalation device of ventilator for the intubated patients.
16033033|NCT02644863|Drug|Paclitaxel|Paclitaxel 175mg/m2 IV over 2 hours,day 1; Repeat every 3 weeks;regimen for 3 cycles
16033034|NCT02644863|Biological|DC-CIK|Antigen-sensitized DC-CIK 8×10^9 autologous tumor lysate pulsed D-CIK cells for each infusion, IV (in the vein) for 3 cycles, each cycle received four infusions on day 14, 16, 30 and 32.
16033035|NCT02644863|Drug|Cisplatin|Cisplatin 30mg/m2 IV on 1-3 days, Repeat every 3 weeks;regimen for 3 cycles
16033036|NCT02644837|Device|Insertion of Ambu AuraGain laryngeal mask airway and Igel|Insertion of Ambu AuraGain and iGel laryngeal mask airways in accordance with manufacturer instruction
16033037|NCT02644837|Device|Fibreoptic assessment with Ambu A-scope|Passage of Ambu a-scope fibrescope down shaft of laryngeal mask airway and assessment of alignment with glottis in relation to amount of glottis that is easily visualised
16033038|NCT02644837|Device|Ability to insert nasogastric tube|Passage of nasogastric tube down the gastric drainage channel of the device in accordance with manufacturer guidance
16033039|NCT02644837|Device|Measurement of OLP|Measurement of OLP by closing the adjustable pressure limiting valve against a constant fresh gas flow rate of 3 litres/minute
16033040|NCT02644837|Device|Ability to perform positive pressure ventilation|The ability to deliver 6 mls/kg volumes breaths by means of positive pressure ventilation will be assessed
16033041|NCT02644837|Device|Assessment of ease of insertion|Ease of insertion will be subjectively assessed by operator in relation to presence and nature of resistance to insertion of the device
16033042|NCT02644837|Device|Record number of manipulations|The number of manipulations/adjustments will be recorded for the second device only for the remainder of the device use during surgery until the patient wakes.
16033043|NCT02644837|Device|Assessment of device related trauma|Observation and assessment of any trauma caused by the insertion of the first device used
16033044|NCT02644824|Device|Biventricular Pacing (BiVp)|BiVp shortens QRS duration and synchronizes ventricular contraction; thereby decreasing wall stress and increasing CI and BP. In contrast to inotropes, BiVp does not increase myocardial VO2. Resynchronizing myocardial contraction normalizes glucose metabolism, myocardial perfusion and distribution of proteins essential to myocardial contraction and relaxation such as calcium-handling phospholamban. Overall, BiVp improves pump function, increases CI, improves myocardial perfusion and reduces VO2, improving hemodynamics.
16033045|NCT02644811|Drug|Topical anesthesia (buccal and palatal)|Saliva is removed with a sterile swab followed by application of 5% Lidocaine gel (APL, Sweden) on the gingiva.
16033046|NCT02644811|Drug|Local anesthesia (buccal and palatal)|Injection of 1,5 ml Xylocaine Dental Adrenaline (Lidocaine hydrochloride 20 mg/ml, adrenaline 12.5 µg/ml, Dentsply Pharmaceutical, Weybridge, Surrey, UK).
16033047|NCT02644811|Procedure|Extraction of the maxillary first premolars|Careful extraction of the maxillary first premolars after mobilization.
16033048|NCT02644811|Drug|Topical anesthesia (buccal)|Saliva is removed with a sterile swab followed by application of 5% Lidocaine gel (APL, Sweden) on the gingiva.
16033049|NCT02644811|Drug|Local anesthesia (buccal)|Injection of 0.3 ml Xylocaine Dental Adrenaline (Lidocaine hydrochloride 20 mg/ml, adrenaline 12.5 µg/ml, Dentsply Pharmaceutical, Weybridge, Surrey, UK).
16033050|NCT02644811|Device|Molarblock|Molarblock is a Stainless steel ligature connecting the maxillary second premolar with the maxillary first and second molar.
16033051|NCT02644811|Device|Spider Screw K1 short neck|The Spider Screw K1 (Health Development Company, Sarcedo, Italy) is a self-drilling and self-tapping screw. Short neck screws (SCR-1508 and SCR-1510) with a diameter of 1.5 mm and length 8 or 10 mm are used.
16033052|NCT02644798|Other|Gene polymorphism|Samples of gene polymorphism in ARDS patients and patients with ARDS risk factors
16033053|NCT02644785|Drug|protamine|Protamine infusion exposures
16033161|NCT02644070|Device|alveolar bone preservation with apatos|graft with cortical porcine bone (Apatos, Osteobiol, Coazze, Italy )
16033054|NCT02644759|Biological|Stem Cell Transplantation|Interventional radiology-mediated transplantation of purified, autologous stem cells into pancreatic artery and capillaries, and intravenous injection of autologous, immunomodulated mononuclear cells.
16033055|NCT02644746|Device|acupuncture|Shenshu (BL23), Dachangshu (BL25), Weizhong (BL40), Chengshan (BL57), Taixi (KI3) acupoints will be used. For bilateral Dachangshu (BL 25), the needle will be inserted vertically at approximately 40-70 mm until participants got a electric shock feeling downward to calves, then the needle should be elevated up 2 mm, without rotating or lifting. For other four acupoints (BL23, BL40, BL57, KI3), they will be inserted 10 to 15 mm in depth with three times light amplitude rotation and lift to induce a sensation of soreness. The manipulations will be performed 3 times in total during 1 session (every 10 min). There are 24 treatment sessions after baseline, 3 times a week, and the patients will undergo a 30-min treatment each session.
16033056|NCT02644746|Device|placebo needle|Acupuncturists will use blunt tip needles (Huatuo, Suzhou, China) that cannot penetrate skin and stimulate deep tissues, and the thrusting and twisting motions will be used by acupuncturists to simulate the treatment and blind the patients. Each placebo needle consists of four parts: needle handle, needle body, blunt tip and adhesive pad. The chosen of acupoints, treatment duration, and frequency of sessions will be the same as the acupuncture group. To guarantee blinding, the investigators will make appointments with each participant on alternate days to prevent crosstalk among groups.
16033057|NCT02644733|Procedure|head of bed elevation 30 degree|the intraabdominal pressure will be measured by nasogastric tube when the head of bed elevated to 30 degree
16033058|NCT02644733|Procedure|urinary catheter|the intraabdominal pressure will be measured by urinary catheter when the patient in supine position
16033059|NCT02644720|Procedure|multifocal intraocular lens implantation|In this group, the surgery was performed with cataract extraction and multifocal intraocular lens (IOL) (Tecnis ZMB00). The standard technique in all patients consisted of sutureless phacomulsifacation using the Legacy 2000 Series and Infinity phacoemulsification machine (Alcon Laboratories Inc., Fort Worth, Texas, USA), with clear corneal incisions up to 3.2 mm and 5.0 to 5.5 mm capsulorhexis. Surgery in the fellow eye was performed 1 month later in each patient.
16033060|NCT02644720|Procedure|monofocal intraocular lens implantation|In the group, the surgery was performed with cataract extraction and monofocal intraocular lens (IOL) (Tecnis ZCB). The surgery technique was same as the multifocal intraocular lens group
16033061|NCT02644720|Drug|Dexamethasone|All patients received subconjunctival dexamethasone (2 mg) during surgery
16033062|NCT02644720|Device|multifocal intraocular lens (IOL) (Tecnis ZMB00)|
16033063|NCT02644720|Device|monofocal intraocular lens (IOL) (Tecnis ZCB)|
16033064|NCT02644707|Dietary Supplement|L-selenomethionine|The group will be randomized to receive organic selenium in the form of L-selenomethionine at the dose of 200mcg daily (intervention group) for 6 months
16033065|NCT02644707|Other|Placebo|The group will be randomized to receive placebo (control group) for 6 months
16033066|NCT02644694|Drug|Dexamethasone Phosphate Ophthalmic Solution|Experimental: Dexamethasone Phosphate Ophthalmic Solution (40 mg/mL) delivered via the EyeGate II Drug Delivery System
16033067|NCT02644681|Procedure|Aortic Aneurysm, Thoracic surgery|
16033068|NCT02644668|Drug|Placebo|Granules for oral suspension (placebo)
16033069|NCT02644668|Drug|Reldesemtiv 150 mg|Granules for oral suspension, 18.7% reldesemtiv
16033070|NCT02644668|Drug|Reldesemtiv 450 mg|Granules for oral suspension, 56.0% reldesemtiv
16033071|NCT02644655|Biological|CD19-specific chimeric antigen receptor|Cyclophosphamide 500 mg - 2000 mg/m2 (day 2) with or without Fludarabine 30 mg/m2 /day, 4 days (day 6, 5, 4, 3); nCAR19-T transfusion：day 0(5×105/kg，1×106/kg，3×106/kg).
16033072|NCT02644642|Other|disconnection technique|Before lung isolation, the ventilator stays switched-off until the carbon dioxide on the capnogram reached to zero. Then, inflate the balloon either on the double lumen tube or on the bronchial blocker.
16033073|NCT02644629|Drug|Placebo|Saline 0.9%, Administration of 0.2mg/kg (IV Push) or 50mg (IN, 5 doses, alternating nostrils)
16033074|NCT02644629|Drug|Ketamine (1st phase)|Administration of 0.2mg/kg (IV Push) or 50mg (IN, 5 doses, alternating nostrils)
16033075|NCT02644629|Drug|Ketamine (2st phase)|Patients failing to achieve response (<50% MADRS score) in the parallal phase, will be offered additional 4 session (twice a week, 2 weeks) of 0.5 mg/kg ketamine over 40 minutes.
16033076|NCT02644616|Drug|tolvaptan+torasemide|tolvaptan 15mg/d po(10 days) + torasemide 20mg/d iv
16033077|NCT02644616|Drug|placebo+torasemide|placebo 15mg/d po(10 days) +torasemide 20mg/d iv
16033078|NCT02644603|Procedure|Enhanced Recovery After Surgery|"Before operation:
~Preoperative optimization of organ function, No preoperative bowel preparation, Prohibit eating 6h, drinking water 2h before operation, Oral rehydration before operation.
~In operation:
~Optimized combined anesthesia, Minimal invasive operations, Normothermia, Minimal use of tubes and drains.
~After operation:
~Postoperative analgesia and antiemetic, Early mobilization, Oral nutrition, Early and scheduled mobilization."
16033079|NCT02644590|Drug|Melatonin|Detailed in arm description
16033080|NCT02644577|Drug|Metformin|
16033081|NCT02644577|Other|Starch|
16033082|NCT02644564|Other|Ultrasonography|One doctor does the clinical examination, another does ultrasonography. Both doctors and patient are blinded until results have been registered on written forms. The results are then disclosed to the patient and doctors in order to plan further treatment.
16033083|NCT02644551|Drug|CELEXT07|
16033084|NCT02644551|Drug|Penlac|
16033085|NCT02644551|Other|vehicle solution|
16033086|NCT02644538|Drug|PegIFN alfa-2a|chronic hepatitis B patients who treated with nucleot(s)ides (including lamivudine, adefovir, entecavir, tenofovir) arrived HBV DNA <1000copies/ml, and HBsAg<3000IU/ml, then change the treatment to original nucleot(s)ides add on PegIFN alfa-2a, the combined treatment is for 48 weeks, and follow up for 24 weeks
16033087|NCT02644525|Drug|Imatinib Mesylate|Imatinib is a small molecule inhibitor which was US Food and Drug Administration (FDA) -approved for chronic myelogenous leukemia (CML) in 2001 which acts on the protein product of the Philadelphia chromosome, Bcr-Abl.
16033088|NCT02644525|Drug|Placebo|Placebo pills
16033089|NCT02644499|Drug|Methotrexate|Methotrexate, a structural analogue of folic acid, can be administered orally or parenterally to treat a variety of rheumatic dise
16033162|NCT02644070|Device|stabilization with membrane|socket stabilization with a collagen membrane (Evolution, Osteobiol, Coazze, Italy)
16033090|NCT02644499|Drug|Leflunomide|Leflunomide inhibits pyrimidine synthesis, resulting in blockade of T-cell proliferation. Leflunomide is used in patients with moderate to severe active rheumatoid arthritis with early or late disease
16033091|NCT02644499|Drug|Hydroxychloroquine|Hydroxychloroquine (HCQ) is a well-tolerated DMARD that is commonly used in combination therapy regimens for RA. HCQ is more commonly used than chloroquine.
16033092|NCT02644499|Drug|Prednisolone|Low dose prednisolone (weeks 1-2: 15 mg/day, weeks 2-4: 10 mg/day, weeks 4-6: 5 mg/day and weeks 6-8: 2.5 mg/day then stop)
16033093|NCT02644499|Drug|Folic Acid|Folic acid is to be given to all patients receiving methotrexate at a dose of 5 mg twice a week.
16033094|NCT02644486|Drug|High dosage Sevelamer Carbonate + Irbesartan|Sevelamer Carbonate 4.8g/d+Irbesartan 300mg/d
16033095|NCT02644486|Drug|Low dosage Sevelamer Carbonate + Irbesartan|Sevelamer Carbonate 2.4g/d+Irbesartan 300mg/d
16033096|NCT02644486|Drug|Irbesartan|Irbesartan 300mg/d
16033097|NCT02644473|Drug|Tranexamic Acid|
16033098|NCT02644473|Drug|Normal saline|Control
16033099|NCT02644460|Drug|Abemaciclib|
16033100|NCT02644447|Biological|HUC-MSCs Transplantation|The patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs.
16033101|NCT02644447|Biological|HUC-MSCs with Injectable Collagen Scaffold Transplantation|The patients with POF that will undergo bilateral ovaries injection of 10 million allogeneic HUC-MSCs with injectable collagen scaffold.
16033102|NCT02644434|Procedure|Conventional Strategy|"Jailed wire technique: Both MV and SB are wired. The MV is stented with wire protection in SB. The SB is not further treated unless there is threatened SB closure, severe ostial pinching of SB (>90%), TIMI flow grade decrease in SB, or SB dissection greater than type A. If one of these criteria exists, the SB would be rewired and a kissing balloon inflation is undertaken.
~Provisional two-stent strategy: Lesion preparation and MV stenting are the same as the jailed wire technique. Provisional T stenting of the SB could be undertaken if one of the following criteria exists after SB rewiring and a kissing balloon inflation is undertaken: threatened SB closure, severe ostial pinching of SB (>90%), TIMI flow grade decrease in SB, or SB dissection greater than type A."
16033103|NCT02644434|Procedure|Intentional strategy|"Jailed balloon technique: The technique has been detailed in previous studies. A monorail balloon that is angiographically sized to approximate the Side Branch (SB) vessel diameter is advanced into the SB. If there is TIMI flow grade decrease in the SB after MV stenting, the SB balloon is inflated to simulate attempt to reopen the SB. The procedure would be completed with the standard kissing balloon technique no matter there is SB compromise or not.
~Elective two-stent strategy: Patients in this subgroup would undergo crush procedure or any other elective two-stent strategy which stenting SB before MV stenting."
16033104|NCT02644421|Drug|VVZ-149|
16033105|NCT02644421|Drug|Lidocaine|
16033106|NCT02644421|Drug|Placebo|
16033107|NCT02644408|Drug|Megestrol（Yining）|Megestrol（Yining）: 160mg/d, po,7 weeks in total, one week before chemoradiotherapy and one week after chemoradiotherapy.
16033108|NCT02644408|Radiation|radiotherapy|radiotherapy (radiation): 50Gy in total，2 Gy/d，5d/w.
16033109|NCT02644408|Other|chemotherapy|capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 weeks in total or capecitabine(Aibin) plus Oxaliplatin(Aiheng)：65mg/m2，d1，8, 22, 29,I.V. or cisplatin: 75mg/m2 d1，29 5-Fu：750mg/m2CIV24h d1-4，d29-32. The 3 regimens were Randomly distributed to patients.
16033110|NCT02644395|Drug|Chlorthalidone|Drug
16033111|NCT02644395|Drug|Amlodipine|Drug
16033112|NCT02644382|Other|qualitative data collection|qualitative data collection
16033113|NCT02644382|Other|survey|survey pre and post-surgical consult
16033114|NCT02644382|Other|decision aid|web-based decision aid post-surgical consult
16033115|NCT02644369|Biological|Pembrolizumab|Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2.
16033116|NCT02644356|Behavioral|Online CE/CME course|Educational modules of a proposed online CE/CME course, module topics consisting of acupuncture, massage, and music-related interventions
16033117|NCT02644343|Device|Custom Sound|Custom Sound is the programming software used to program Nucleus cochlear implants.
16033118|NCT02644330|Procedure|transthoracic device closure|minimally invasive transthoracic device closure
16033119|NCT02644330|Procedure|surgical repair|surgical repair with cardiopulmonary bypass
16033120|NCT02644317|Device|Modified shoe inserts|For experimental arm: wear modified shoe inserts and shoes for balance test.
16033121|NCT02644304|Drug|Clomiphene citrate|50 mg tablet twice daily from the second day of menses to the sixth day
16033122|NCT02644304|Drug|Cabergoline|Cabergoline 0.25 mg (half tablet) every 3 days (4 doses).
16033123|NCT02644304|Other|Placebo|placebo(half tablet) every 3 days (4 doses).
16033124|NCT02644291|Drug|Mebendazole|chewable mebendazole tablets that can also be crushed and mixed with food or drink to be taken daily with meals
16033125|NCT02644278|Drug|VX-984 120 mg + PLD 40 mg/m^2|Participants received VX-984 orally 120 milligram (mg) orally once daily alone on Days -14 to -12 of a 14-day Lead-in Period, followed by VX-984 120 mg in combination with pegylated liposomal doxorubicin (PLD) 40 milligram per square meter (mg/m^2) administered intravenous infusion, with PLD administered on Day 1 and VX-984 administered on Day 2 to Day 4 for up to six 28-day cycle or until disease progression unacceptable toxicities, withdrawal of consent, or until exposure to PLD exceeded 550 mg/m^2.
16033126|NCT02644278|Drug|VX-984 240 mg + PLD 40 mg/m^2|Participants received VX-984 orally 240 mg orally once daily alone on Days -14 to -12 of a 14-day Lead-in Period, followed by VX-984 240 mg in combination with PLD 40 mg/m^2 administered intravenous infusion, with PLD administered on Day 1 and VX-984 administered on Day 2 to Day 4 for up to six 28-day cycle or until disease progression unacceptable toxicities, withdrawal of consent, or until exposure to PLD exceeded 550 mg/m^2.
16033127|NCT02644278|Drug|VX-984 480 mg + PLD 40 mg/m^2|Participants received VX-984 orally 480 mg orally once daily alone on Days -14 to -12 of a 14-day Lead-in Period, followed by VX-984 480 mg in combination with PLD 40 mg/m^2 administered intravenous infusion, with PLD administered on Day 1 and VX-984 administered on Day 2 to Day 4 for up to six 28-day cycle or until disease progression unacceptable toxicities, withdrawal of consent, or until exposure to PLD exceeded 550 mg/m^2.
16033160|NCT02644070|Device|alveolar bone preservation with mp3|graft with corticocancellous porcine bone and collagen (MP3, Osteobiol, Coazze, Italy)
16033128|NCT02644278|Drug|VX-984 720 mg + PLD 40 mg/m^2|Participants received VX-984 orally 720 mg orally once daily alone on Days -14 to -12 of a 14-day Lead-in Period, followed by VX-984 720 mg in combination with PLD 40 mg/m^2 administered intravenous infusion, with PLD administered on Day 1 and VX-984 administered on Day 2 to Day 4 for up to six 28-day cycle or until disease progression unacceptable toxicities, withdrawal of consent, or until exposure to PLD exceeded 550 mg/m^2.
16033129|NCT02644252|Drug|Day 1: Cisplatin 75 mg/m2|
16033130|NCT02644252|Drug|Day 1: Vinorelbine 25 mg/m2|
16033131|NCT02644252|Drug|Day 8: Capsule vinorelbine 50 mg/m2|
16033132|NCT02644252|Drug|Day 1: Carboplatin AUC=5|
16033133|NCT02644252|Drug|Day 1: Vinorelbine 30 mg/m2|
16033134|NCT02644252|Drug|Day 8: Capsule vinorelbine 60 mg/m2|
16033135|NCT02644252|Dietary Supplement|Tocotrienol 300 mg x 3 daily until progression|
16033136|NCT02644252|Drug|Placebo 1 capsule x 3 daily until progression|
16033137|NCT02644239|Dietary Supplement|ketogenic diet|Ketogenic diet with high fat (90%)
16033138|NCT02644226|Other|Sevoflurane|The investigators retrospectively reviewed and analyzed the electrical medical records of consecutive children aged 1 to 15 years who underwent general anesthesia under supraglottic airways using sevoflurane as maintenance agents.
16033139|NCT02644226|Other|Desflurane|The investigators retrospectively reviewed and analyzed the electrical medical records of consecutive children aged 1 to 15 years who underwent general anesthesia under supraglottic airways using desflurane as maintenance agents.
16033140|NCT02644213|Other|protocol of using CAREN and MOTEK systems|"The subjects will perform randomly 3 experimental days (at least weak between one to another):
~simulated road march using a virtual reality environment without additional load
~simulated road march using a virtual reality environment which combines cognitive load during the road march. Cognitive tasks for example: navigation, identification and remembering cars/aircraft.
~without physical or cognitive load (without march, waiting between performance evaluations) as control."
16033141|NCT02644200|Device|Gelatin tannate|
16033142|NCT02644187|Device|BF-RhodoLED|Infrared light, with total dose of 37J/cm2.
16033143|NCT02644187|Device|Aktilite CL128|Infrared light, with total dose of 37J/cm2.
16033144|NCT02644187|Drug|BF200-ALA/5-aminolevulinic acid|Prodrug applied to whole treatment area previous to illumination with either light source.
16033145|NCT02644174|Procedure|Bariatric Surgery|
16033146|NCT02644161|Procedure|Dense cranial electroacupuncture stimulation|"DCEAS is a novel stimulation mode in which electrical stimulation is delivered on acupoints located on the forehead.
~Six pairs of acupoints are used: Baihui (GV20, +) and Yintang (EX-HN3, -), left Sishencong (EX-HN1, -) and Toulinqi (GB15, +), right Sishencong (EX-HN1, -) and Toulinqi (GB15, +), bilateral Shuaigu (GB8, L+, R-), bilateral Taiyang (EX-HN5, L+, R-), and bilateral Touwei (ST8, L+, R-).
~Disposable acupuncture needles (Hwato®, 0.30 mm in diameter and 25-40 mm in length) are inserted at a depth of 10-30 mm perpendicularly or obliquely into acupoints. Manual manipulation is then conducted to evoke needling sensation, followed by electrical stimulation (ITO ES-160, continuous waves at 2 Hz, 100 µs)."
16033147|NCT02644161|Procedure|Body acupuncture|"Following acupoints are used: Shui-Gou (GV26), Shen-Men (HT7). He-Gu (LI4), Qu-Chi (LI11), Guan-Yuan (CV4), Zu-San-Li (ST36), Feng-Long (ST40) and San-Yin-Jiao (SP6).
~Disposable acupuncture needles (Hwato®, 0.30 mm in diameter and 25-40 mm in length) are inserted at a depth of 10-30 mm perpendicularly or obliquely into acupoints. Manual manipulation is then conducted to evoke needling sensation at 15 min. No electrical stimulation is delivered."
16033148|NCT02644161|Drug|Antidepressant|Patients will continue their existing antidepressant therapy as usual. Treatment regimens may be further adjusted during 8 weeks of study, depending upon physicians' discretion.
16033149|NCT02644161|Other|Rehabilitation|Patients will continue their existing rehabilitation therapy as usual. Treatment regimens may be further adjusted during 8 weeks of study, depending upon physicians' discretion.
16033150|NCT02644161|Procedure|Least acupuncture stimulation|The acupoints chosen are less related to the treated syndromes based on Traditional Chinese Medicine (TCM) theory; the number of acupoints used and the intensity of electrical stimulation are also lower than the comprehensive acupuncture regimen. The following 6 acupoints will be used in LAS control: bilateral Tong-Tian (BI7, L+, R-), bilateral Shou San-Li (LI10) and bilateral Fu-Yang (BL59). Electrical stimulation will be only performed on bilateral Tong-Tian (BI7) and the intensities are adjusted to a level at which patients just start feeling the stimulation.
16033151|NCT02644148|Procedure|Conventional Roux-en-Y Gastrojejunostomy|Conventional Roux-en-Y Gastrojejunostomy after laparoscopic distal gastrectomy for early gastric cancer patients
16033152|NCT02644148|Procedure|Uncut Roux-en-Y Gastrojejunostomy|Uncut Roux-en-Y Gastrojejunostomy after laparoscopic distal gastrectomy for early gastric cancer patients
16033153|NCT02644135|Drug|Halo Oral Spray|Three sprays per use, total = 9 sprays per day
16033154|NCT02644135|Drug|Halo Placebo|Three sprays per use, total = 9 sprays per day
16033155|NCT02644122|Drug|SF1126|
16033156|NCT02644109|Dietary Supplement|Phytosterol|"Day 1: Anthropometry, laboratory test, dietary intake (24 hour recall and food frequency questionnaire) and presence of symptoms and side effects will be determined, a logbook will be provided to record product consumption, symptoms, medications and side effects. Then will be randomly assigned to one of the groups.
~Days 7 & 21: 24 hour recall, review of symptoms, side effects and adherence as registered in the logbook.
~Days 15 & 30: Anthropometry, vital signs, venous blood sample, review of symptoms, side effects and adherence to intervention as registered on logbook, dietary intake (24-hour recall), delivery of monetary compensation proportional to the study days will be given before being discharged."
16033157|NCT02644109|Dietary Supplement|Placebo|"Day 1: Anthropometry, laboratory test, dietary intake (24 hour recall and food frequency questionnaire) and presence of symptoms and side effects will be determined, a logbook will be provided to record product consumption, symptoms, medications and side effects. Then will be randomly assigned to one of the groups.
~Days 7 & 21: 24 hour recall, review of symptoms, side effects and adherence as registered in the logbook.
~Days 15 & 30: Anthropometry, vital signs, venous blood sample, review of symptoms, side effects and adherence to intervention as registered on logbook, dietary intake (24-hour recall), delivery of monetary compensation proportional to the study days will be given before being discharged."
16033158|NCT02644096|Other|counselling and support after discharge from hospital|patients were contacted by telephone 2 times after discharge from surgery by a specialist nurse, who followed an interview guide due to nursing-rehabilitation after THR
16033163|NCT02644057|Drug|Milrinone|Patients who meet the inclusion criteria for the study will receive milrinone and patients will be monitored for improvement of the renal function objectively with measures such as Blood urea nitrogen, creatinine , daily urine output and changes in weight
16033164|NCT02644057|Drug|Dobutamine|Patients who meet the inclusion criteria for the study will receive dobutamine and patients will be monitored for improvement of the renal function objectively with measures such as Blood urea nitrogen, creatinine , daily urine output and changes in weight
16033165|NCT02644044|Drug|Intrathecal methotrexate|12.5 mg of methotrexate diluted to a concentration of up to 4 mg/mL in 0.9 percent sodium chloride with 4 mg Dexamethasone via lumbar puncture needle.
16033166|NCT02644031|Procedure|mtwo rotary system|post-treatment pain after using mtwo rotary system
16033167|NCT02644031|Procedure|safe-sider rotary system|post-treatment pain after using safe-sider rotary system
16033168|NCT02644031|Procedure|hand files|post-treatment pain after using hand files
16033169|NCT02644018|Drug|Imidazolyl ethanamide pentandioic acid|
16033170|NCT02644018|Drug|placebo|
16033171|NCT02644005|Device|Smart Vent Control|Smart Vent Control (SVC) was designed to automatically control the following ventilator settings: mechanical breathing frequency, inspiratory pressure, pressure support, inspiratory time, trigger sensitivity. SVC adjusts the ventilator settings with the aim to keep a patient stable in a target zone (TZ). Numerous predefined TZs exist that can be set according to the current therapeutic situation. All TZs are adoptable by the user for each individual patient and consist of upper and lower limits for tidal volume and for the partial pressure of end-tidal carbon dioxide (PetCO2). Based on these limits, the system classifies the current quality of ventilation, called Classification of Ventilation, and derives new ventilator settings accordingly. SVC is available as a software option on Zeus Infinity Empowered anesthesia machines (Drägerwerk AG & Co. KGAa, Lübeck, Germany) and is approved as a medical product according to 93/42/European Economic Community.
16033172|NCT02643992|Other|DOAC concentration measurement|
16033173|NCT02643979|Drug|Ketofol|50mg of Ketamine mixed with 100mg of Propofol
16033174|NCT02643979|Drug|Propofol|100mg of Propofol
16033175|NCT02643979|Drug|Saline|1mL of saline
16033176|NCT02643966|Device|Whole breast ultrasound|Breast cancer screening with whole breast ultrasound
16033177|NCT02643953|Behavioral|Incentives|1) provision of incentives to encourage women to attend primary health care and use family planning, antenatal, delivery and postnatal services; 2) conditional cash transfers to promote uptake of services; 3) targeted community health education and advocacy activities; 4) community maternal audit/accountability activities, with community-led activities aimed at promoting utilization of services
16033178|NCT02643953|Behavioral|Community|1) outreach services by PHCs; 6) PHC strengthening including training of health providers; and 2) training and kitting of community health rangers who will be trained to follow up women at home to ensure that they do not default but that they continue to use PHC services until delivery.
16033179|NCT02643927|Behavioral|standard 8-weeks MBSR|A 8 weekly sessions of 120 min based on the standard protocol of Kabat Zinn was performed. The adapted program did not include a one-day retreat in silence, but one session in silence plus extra kindly awareness (compassion-based) and value-based exercises. Home practice was not systematically assessed, but recommended to be of 45min per day, most of the days. It was administered by a trained (3-y experience) and certified MBSR teacher (MMPD).
16033180|NCT02643927|Behavioral|4-week shortened MBSR|This protocol was made up of 4 sessions of 120 mn administered by the same trained MBSR programme therapist to avoid variables associated to the therapist. The rationale behind the shortened version of MBSR was to keep the core content and practices of the program, in fewer sessions: raisin exercise (experiential concept of mindfulness); and main anchors of attention (breathing, body sensations, body movements).
16033181|NCT02643914|Drug|Nicotine|
16033182|NCT02643914|Device|MR Compatible Nicotine Delivery Device|
16033183|NCT02643901|Biological|GW003|single SC injection
16033184|NCT02643875|Device|Orthokeratology|It is a kind of rigid permeable lens.
16033185|NCT02643862|Drug|Xolair|Xolair is a monoclonal antibody approved by the FDA for asthma and chronic urticaria
16033186|NCT02643862|Drug|Placebo|Placebo
16033187|NCT02643849|Device|The Spanner Temporary Prostatic Stent|
16033188|NCT02643836|Device|PEMF|The PEMF device (Rio Grande Neurosciences - RGN) the investigators would be testing has been shown to have significant anti-inflammatory effects in animals and humans and an excellent safety profile in several clinical studies. Key findings demonstrated that PEMF-treated rodents with a closed-head TBI exhibited a 5-fold decrease in IL-1b in the cerebral spinal fluid, an outcome associated with decreased neuropathology and improved function.
16033189|NCT02643823|Biological|hUC-MSC + DMARDs|Patients will be treated by conventional drugs (DMARDs) for alleviating disease. Combinated with a single dose of 2×107 hUC-MSC will treated to patients, IV, Repeat every weeks for four times.
16033190|NCT02643823|Drug|DMARDs|Patients will be treated by conventional drugs (DMARDs) for alleviating disease.
16033191|NCT02643810|Other|Exercise training|Patients to be randomized to the 'interval training group' or 'continuous training group' will undergo exercise training sessions 3 times per week for a period of 12 weeks.
16033192|NCT02643797|Behavioral|Medical Assistant Health Coaching|One-on-one behavioral health screening and tailored intervention by the MA health coach with patients who have type 2 diabetes.
16033193|NCT02643784|Drug|Rosuvastatin|"Randomized Treatment Period (Day 1 through Day 14): 20 mg once daily for 14 days.
~Follow up Period (Day 15 through Day 90) Subjects in both groups who enter the follow up period will receive rosuvastatin 10mg/day."
16033194|NCT02643784|Other|Control|"Randomized Treatment Period (Day 1 through Day 14):
~No treatment of rosuvastatin for control group. Follow up Period (Day 15 through Day 90) Subjects in both groups who enter the follow up period will receive rosuvastatin 10mg/day."
16033195|NCT02643771|Procedure|Full Mouth Scaling and Root Planing|This procedure was performed as described by Quirynen et al. 2005 with some modifications
16033196|NCT02643758|Device|Bifocal soft contact lenses|
16033223|NCT02643602|Other|Hydration with sodium chloride in addition to theophylline|0.9% sodium chloride; 3 ml per kg bodyweight (maximum 330 ml) one hour before contrast exposure; additionally 200 mg theophylline as a short infusion; after contrast application hydration with another 1 ml per kg bodyweight per hour (maximum 110 ml per hour) for 6 hours
16150559|NCT01776528|Biological|Placebo|
16033197|NCT02643745|Procedure|Nephrology Intervention|"pre-operative study:
~Kidney function: creatinine, Glomerular filtration rate (GFR) and presence albuminuria or proteinuria. Assessment whether there is a functional component added.
~Discard presence of renal disease: renovascular disease, glomerular disease, toxic, etc.
~optimise the patient' s overall condition with a pre-operative strategy:
~Obesity control
~Control protein, caloric, salt intake
~Stop smoking
~Good glycemic control
~Start ACEI/ARA II if there is proteinuria
~Start additional antihypertensive drug if required
~Start hypolipemic treatment if required
~Start hyperuricemia treatment if required
~Start AAS, clopidogrel if it is necessary (prophylaxis)
~Phosphate control
~Anemia control
~Metabolic acidosis correction"
16033198|NCT02643732|Drug|Methylphenidate (overencapsulated)|10mg (1 capsule) methylphenidate (standard release) twice daily, increased to 20mg (2 capsules) twice daily after 2 weeks. The drug can be down-titrated in the event of side effects, although re-uptitration is not allowed even if the side effects resolve on the lower dose.
16033199|NCT02643732|Drug|Placebo (Over-encapsulated tablet)|Identical capsules (over-encapsulated placebo tablets), administered initially one capsule twice daily, increased to 2 capsules after 2 weeks. As with the methylphenidate arm, the dose can be down-titrated in the event of side effects, although re-uptitration is not allowed even if the side effects resolve on the lower dose.
16033200|NCT02643719|Behavioral|Relaxation Therapy|Between 30-60 minutes after the standard of care medication administration (metoclopramide, magnesium, prochlorperazine, ketorolac, or steroids at discretion of treating physician), patient receives training in relaxation therapy.
16033201|NCT02643719|Drug|Topiramate|"Preventive medication prescriptions given to the patient along with written instructions and information about side effects:
~Topiramate 25mg tabs (with a plan to increase to 100mg)"
16033202|NCT02643719|Drug|Standard of Care|Standard discharge instruction sheet plus standard of care medication as prescribed by treating physician. The clinical team will be instructed to address post-discharge care as appropriate
16033203|NCT02643719|Drug|Abortive Medication (Naproxen and Sumatriptan)|All participants will receive abortive medication for acute treatment of their migraine. Preferred medications are Naproxen (500mg) and Sumatriptan (100mg)
16033204|NCT02643693|Other|P3L|"Ad libitum use for a maximum of three hours.
~P3L delivers, on average, 80 µg of nicotine per puff under Health Canada Intense smoking regime."
16033205|NCT02643693|Other|VUSE|"Ad libitum use for a maximum of three hours.
~VUSE delivers, on average, 80 µg of nicotine per puff based on the CORESTA e-cigarette recommended smoking regime."
16033206|NCT02643693|Other|CC|Ad libitum use of the subject's own brand of non-menthol CC for a maximum of three hours.
16033207|NCT02643680|Device|The novel biocellulose wound dressing|The novel biocellulose dressing will used as a primary dressing at one half of the donor site. Then,the wound will be covered with 2 layers of gauze (secondary dressing) and 1 layer of bandage.The primary dressing will be unchanged until the wound healing (the day that the dressing detaches by itself with no exudate and air contacted pain) except signs of infection. The secondary dressing will be changed when excessive fluid appears.
16033208|NCT02643680|Device|Bactigras|Bactigras will used as a primary dressing at another one half of the donor site. Then,the wound will be covered with 2 layers of gauze (secondary dressing) and 1 layer of bandage.The primary dressing will be unchanged until the wound healing (the day that the dressing detaches by itself with no exudate and air contacted pain) except signs of infection. The secondary dressing will be changed when excessive fluid appears.
16033209|NCT02643667|Drug|Ibrutinib|-Ibrutinib will be supplied by Pharmacyclics Inc.
16033210|NCT02643667|Procedure|Blood samples for PSA and immune assays|"PSA: Baseline, week 1, week 5, and post-radical prostatectomy follow-up visit
~Immune Assays: baseline, week 5, and post-radical prostatectomy follow-up visit"
16033211|NCT02643667|Procedure|Radical prostatectomy|-Standard of care
16033212|NCT02643654|Drug|MABp1|This is a sterile injectable liquid formulation of 50 mg/mL MABp1 in a stabilizing isotonic buffer (pH 6.4). Each 10-mL serum vial contains 6 ml of the formulation, and is sealed with a 20-mm grey bromobutyl stopper and flip-off aluminum seal
16033213|NCT02643654|Drug|Placebo|The placebo dosage form is a sterile isotonic formulation buffer at pH 6.2-6.5. Each 10-ml Type I borosilicate glass serum vial contains 6mL of the formulation buffer, and is sealed with a 20-mm Daikyo Flurotec butyl rubber stopper and flip-off aluminum seal.
16033214|NCT02643641|Biological|BM32|BM32 is a mixture of 4 different recombinant proteins directed at the major grass pollen allergens, adsorbed on aluminum hydroxide
16033215|NCT02643641|Biological|Placebo|Placebo contains aluminum hydroxide only
16033216|NCT02643628|Procedure|Microneedling|
16033217|NCT02643628|Device|Microneedling followed by Bellafill treatment|
16033218|NCT02643615|Device|VEP under TIVA|Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
16033219|NCT02643615|Device|VEP under balanced anesth.|Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
16033220|NCT02643615|Drug|Propofol|Propofol will be administered for anesthesia maintenance in patients randomized to the TIVA arm of the study. In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
16033221|NCT02643615|Drug|Desflurane|Balanced general anesthesia with desflurane will be administered for anesthesia maintenance in patients randomized to the balanced general anesthesia arm of the study, In order to record the VEPs, standard half-inch sub-dermal needle electrodes will be inserted subcutaneously around the visual area and the SightSaverTM visual stimulator will be placed to monitor VEP during surgery.
16033222|NCT02643602|Other|Hydration with bicarbonate in addition to theophylline|0.154-molar sodium bicarbonate; 3 ml per kg bodyweight (maximum 330 ml) one hour before contrast exposure; additionally 200 mg theophylline as a short infusion; after contrast application hydration with another 1 ml per kg bodyweight per hour (maximum 110 ml per hour) for 6 hours
16033457|NCT02641899|Drug|Lisinopril|Oral lisinopril 20 mg on Day 2 and Day 28
16033224|NCT02643589|Drug|ATG|ATG will be intravenously infused via a central venous catheter in 3 or 4 days, from day -4 or -3 until day 0. The other conditioning drugs administered before transplantation include cytosine arabinoside (Ara-C), busulfan (Bu),cyclophosphamide (Cy), Semustine(Me-CCNU), and ATG. All transplant recipients will receive cyclosporine A (CsA), mycophenolate mofetil(MMF), and short-term methotrexate for aGVHD prevention.
16033225|NCT02643576|Behavioral|F&V Bonus|To examine the independent effect of offering an incentive (i.e. bonus dollars for fruit and vegetable purchases) to SNAP-like benefits to encourage the purchase of more healthful foods
16033226|NCT02643576|Behavioral|Restriction|To examine the independent effect of prohibiting the use of SNAP-like benefits to purchase foods high in discretionary calories (i.e.sugar-sweetened beverages, candy, or sweet baked goods) on food purchases and diet quality
16033227|NCT02643576|Behavioral|Bonus & Restriction|To examine the joint effects of prohibiting the use of SNAP benefits to purchase foods high in discretionary calories and offering an incentive to encourage the purchase of more healthful foods
16033228|NCT02643563|Drug|Ropivacaine 0.5%|Ropivacaine 0.5% is used for low-volume ultrasound-guided interscalene brachial plexus block.
16033229|NCT02643563|Drug|Ropivacaine 1%|Ropivicaine 1% is used for low-volume ultrasound-guided interscalene brachial plexus block.
16033230|NCT02643563|Drug|Bupivacaine 0.5% + epinephrine 1:200,000|Bupivacaine 0.5% + epinephrine 1:200,000 is used for low-volume ultrasound-guided interscalene brachial plexus block.
16033231|NCT02643550|Biological|Monalizumab|
16033232|NCT02643550|Biological|Cetuximab|
16033233|NCT02643550|Biological|Anti-PD(L)1|
16033234|NCT02643524|Behavioral|Nutrition and Exercise Counseling|Patients are prescribed CAM boot and provided nutritional and upper body exercise counseling at the time the CAM boot is dispensed. Patients will be given a diary to complete their daily meal intake (optional), seated upper body physical exercise guidelines and asked to perform them three days per week and each exercise three times per session if able. They will be asked to record number of hours CAM boot is worn daily in the Patient Diary, if one is utilized. Albumin lab test will be drawn and their height and weight measured.
16033235|NCT02643524|Behavioral|Control|Patients are prescribed CAM boot. No nutritional or exercise guidelines will be provided. Patients will be given a diary to complete their daily meal intake and physician exercise (if any) and number of hours CAM boot is worn daily. Albumin lab test will be drawn and their height and weight measured.
16033236|NCT02643511|Radiation|Transperineal template guided mapping biopsy, multiparametric MRI, Hemiablative Focal Brachytherapy|A re-staging transperineal template guided mapping prostate biopsy as currently performed at participating institutions. Hemiablative Focal brachytherapy will be performed . The affected half of the prostate will be targeted with the prescription dose and receive 145 Gy of Iodine-125 (I-125). A postimplant dosimetry will be performed 30 days after procedure. The quality-of-life assessment will focus on erectile function, urinary function, bowel function, and general health related quality of life. The patients will complete this assessment at baseline and then 4 weeks, 6 months, 12 months, 20 months, 24 months, 32 months and 36 months after treatment. A second transperineal biopsy will be performed 36 months after the implant.
16033237|NCT02643498|Radiation|Stereotactic Body Radiotherapy (SBRT)|
16033238|NCT02643485|Procedure|Forefoot surgery|Forefoot surgery (Chevron, Scarf, Lapidus, Arthrodesis)
16033239|NCT02643472|Behavioral|Parent Navigator|Parents will be contacted by the parent navigator within 2 business days after discharge to assess how the family is coping, answer questions, and provide necessary resources. Navigators will be in touch with families monthly and according to the parent's needs. They will assist the parent in making and keeping appointments, answer questions about insurance coverage, medical equipment and supplies, and serve as a liaison between parent and healthcare providers. However, the specific PN intervention for each family will be based on each family's needs and therefore may differ.
16033240|NCT02643472|Behavioral|Care Notebook|A care notebook will be provided to all parents at discharge. The notebook was created to provide resources and serve as an organizer for appointments for parents of NICU graduates. It was based on peer to peer feedback from former NICU parents, in addition, to community resources developed by current Parent Navigator Program at Children's National Health System.
16033241|NCT02643459|Behavioral|suPAR measurement|The biomarker suPAR will be measured on all patients included in the study. Before the study period the doctors will receive information on suPAR. We want to study if the information provided by suPAR is useful in emergency medicine. Interventions depends on the clinical issue, as suPAR is an unspecific marker of disease. Usually a elevated suPAR level could result in more investigation e.g. diagnostic procedures or follow up, while a low suPAR could result in faster discharge.
16033242|NCT02643446|Biological|IPV|IPV will be vaccinated at 2 months of age act as the first dose of poliovirus vaccine in the study group1 to group 4,group8 to group 11. IPV will be given at 3 month of age act as second vaccine in group 8,9,12
16033243|NCT02643446|Biological|OPV|"OPV will be vaccinated at 3 and 4 months of age, act as the second and third dose of poliovirus vaccine in the study group 1 to group 4,group 10 to group 11.
~OPV will be vaccinated at 2, 3 and 4 months of age act as the full three primary immunization doses of polio virus vaccine in the study group 5 to group 7."
16033244|NCT02643433|Biological|Measles-Rubella combined vaccine(MR)|0.5ml for each dose,be administered by single use syringe subcutaneously in the lower part of the deltoid area of lateral arm.
16033245|NCT02643433|Biological|Japanese Encephalitis alive vaccine(JE)|0.5ml for each dose be administered by single use syringe subcutaneously in the lower part of the deltoid area of lateral arm.
16033246|NCT02643420|Drug|SPI-2012|Supplied in prefilled single-use syringes for subcutaneous injection, administered on Day 2 of each cycle.
16033247|NCT02643420|Drug|Pegfilgrastim|Single-dose subcutaneous injection administered on Day 2 of each cycle.
16033248|NCT02643420|Drug|Docetaxel|Standard therapy
16033249|NCT02643420|Drug|Cyclophosphamide|Standard therapy
16033250|NCT02643407|Drug|Docetaxel|60mg/m2
16033251|NCT02643407|Drug|Nedaplatin|80mg/m2
16033252|NCT02643407|Drug|Cisplatin|75mg/m2
16033253|NCT02643394|Drug|Oral Acetaminophen|1000mg oral acetaminophen + 400mg oral celecoxib given within one hour of incision
16033254|NCT02643394|Drug|Intravenous acetaminophen|400mg oral celecoxib given within one hour of incision + 1000mg IV acetaminophen within one hour prior to anesthetic emergence.
16033458|NCT02641899|Drug|Warfarin|Oral warfarin 25 mg on Day 2 and Day 28
16033255|NCT02643381|Drug|Etomidate|Patients randomized to this group will receive etomidate immediately prior to emergency endotracheal intubation.
16033256|NCT02643381|Drug|Ketamine|Patients randomized to this group will receive ketamine immediately prior to emergency endotracheal intubation.
16033257|NCT02643381|Procedure|Emergency Endotracheal Intubation|Patients enrolled in the study will be endotracheally intubated. (A breathing tube will be placed into the patient's mouth and trachea). This procedure is being done as part of standard emergency care. Standard endotracheal tubes will be used. Our hospital uses primarily Mallinckrodt (TM) brand endotracheal tubes.
16033258|NCT02643381|Device|Mechanical Ventilation|Patients enrolled in the study will be mechanically ventilated, using a standard ventilator used in our hospital. The mechanical ventilator is attached to the patient's endotracheal tube and helps sustain the patient's life. Our hospital uses several brands of mechanical ventilators.
16033259|NCT02643368|Biological|mOPV2 at 6 and 7 weeks of age|Participants assigned to this intervention will receive a dose of monovalent oral type 2 polio vaccine (mOPV2) at 6 and 7 weeks of age
16033260|NCT02643368|Biological|mOPV2 at 6 and 8 weeks of age|Participants assigned to this intervention will receive a dose of monovalent oral type 2 polio vaccine (mOPV2) at 6 and 8 weeks of age
16033261|NCT02643368|Biological|mOPV2 at 6 and 10 weeks of age|Participants assigned to this intervention will receive a dose of monovalent oral type 2 polio vaccine (mOPV2) at 6 and 10 weeks of age
16033262|NCT02643368|Biological|IPV at 6 weeks of age|Participants assigned to this intervention will receive a dose of inactivated polio vaccine (IPV) 6 weeks of age
16033263|NCT02643355|Drug|Olanzapine|
16033264|NCT02643355|Drug|Clonidine|
16033265|NCT02643342|Device|Orthokeratology|
16033266|NCT02643329|Drug|BF-Gliclazide Tablet 80mg|BF-Gliclazide Tablet is a generic product manufactured by Bright Future Pharmaceuticals Factory O/B Bright Future Pharmaceutical Laboratories Limited
16033267|NCT02643329|Drug|Diamicron 80mg Tablet|Diamicron 80mg Tablet is manufactured by Les Laboratoires Servier Industrie, France
16033268|NCT02643316|Drug|Same day 4 L preparation (Polyethylene Glycol)|Receive 1 gallon (4 L) of Polyethylene Glycol preparation on the morning of the colonoscopy.
16033269|NCT02643316|Drug|Split dose 4 L preparation (Polyethylene Glycol)|Receive the split-dose regimen. Will take half (2 L) the preparation the evening before colonoscopy and half (2 L) on the morning of the procedure.
16033270|NCT02643303|Drug|Durvalumab|
16033271|NCT02643303|Drug|Tremelimumab|
16033272|NCT02643303|Drug|Poly ICLC|
16033273|NCT02643290|Device|Peak Scoliosis Bracing System|Brace is fit to adult scoliosis patients for 2-4 hours a day and tracked for six months.
16033274|NCT02643277|Behavioral|Mobile phone text messaging|The intervention will be text messages delivered by an automated text messaging manager. The message content will be designed to induce lifestyle modification (diet and physical activity) and will be motivational, based on the content which has been proven to be effective in reducing progression to diabetes in people with pre-diabetes. Other text messages will aim to improve drug compliance and disease monitoring, based on our pilot studies in India. The control arm will receive conventional management, according to local guidelines in the Indian centers, which in all cases are compatible with those of the International Diabetes Federation.
16033275|NCT02643277|Other|Conventional care|Conventional care is comprised of a one-to-one interview by a trained research personnel on diet and exercise advice at baseline and during every visit. The goals were to reduce portion size (total calories) and, to avoid simple sugars and refined carbohydrates, reduce total fat intake, restrict use of saturated fat, include more fibre rich food-(e.g., whole grains, legumes, vegetables, and fruits).
16033276|NCT02643264|Other|rTMS 10 Hz targeting the insula|Participants will receive a total of 15 sessions of rTMS targeting the insula bilaterally, Stimulation will be delivered at an intensity of 120% of the motor threshold (MT), with a frequency of 10 Hz, delivered as 50 trains of 30 pulses delivered in each train of 3 seconds duration, with a 20 seconds inter-train interval, for a total of 1500 pulses delivered over app. 20 min. On the very first two sessions stimulations will be given at lower strength for adaptation, starting at 100% for the first and 110% for the second session
16033277|NCT02643264|Other|Sham rTMS|Sham stimulation with the same regimen as active treatment
16033278|NCT02643251|Drug|Clonidine Hydrochloride Topical Gel, 0.1%|Clonidine Gel is supplied as an aqueous gel formulation for topical use.
16033279|NCT02643251|Drug|Clonidine Hydrochloride Gel Comparator|Clonidine Gel Comparator is supplied as an aqueous gel formulation for topical use.
16033280|NCT02643238|Device|BrainPort|This system is a novel, bionic, non-invasive, vision bypass system that conveys environment images from a spectacle-frame-mounted video-camera to the brain via an electro-tactile tongue array. The electro-tactile stimulation delivered by the tongue-array placed on the tongue allows users to interpret the images of objects in their camera's visual field
16033281|NCT02643212|Drug|Rivaroxaban|
16033282|NCT02643212|Drug|Placebo|
16033283|NCT02643186|Drug|preoperative vaginal misoprostol|preoperative vaginal misoprostol 400 micrograms 1 hour before surgery
16033284|NCT02643186|Procedure|bilateral uterine artery ligation|bilateral ascending uterine artery ligation at the level of uterine isthmus with 2/0 vicryl sutures
16033285|NCT02643173|Other|Volatile anesthetics|
16033286|NCT02643173|Other|Intravenous anesthetics|
16033287|NCT02643160|Other|Functional Trunk Training|The intervention includes neurodevelopment treatment, muscle strengthening and functional activities of trunk region
16033288|NCT02643147|Drug|CA125 guided strategy|Initial dose of intravenous furosemide ≤80 mg / day regardless of prior dose of loop diuretics who were receiving.
16033289|NCT02643147|Drug|CA125 guided strategy|Initial dose of intravenous furosemide ≥120 mg/day or 2.5 times the dose the patient was taking at home.
16033290|NCT02643147|Drug|Conventional Strategy|The dosage of loop diuretics is done according to the presence of symptoms and signs of systemic congestion and current recommendations
16033291|NCT02643134|Procedure|extracorporeal shockwave lithotripsy|Patients in Group 1 undergo extracorporeal shockwave lithotripsy(ESWL).
16033292|NCT02643134|Device|External Physical Vibration Lithecbole|Multi-dimensional physical harmonic vibration inertial guidance technology
16033293|NCT02643121|Other|therapy sepsis|Treatment of sepsis varies depending on the site and cause of the initial infection, the organs affected and the extent of any damage
16033459|NCT02641899|Drug|Digoxin|Oral digoxin 0.5 mg on Day 2 and Day 28
16033294|NCT02643108|Procedure|Lateral episiotomy|When the woman is randomized to episiotomy, lateral episiotomy is performed with scissors on the left or right side of the vaginal opening. Origin of incision is 1.0 - 3.0 cm from the midline/posterior forchette and is cut 3.0 cm or more towards the ischial tuberosity at an angle of 60 degrees from the midline.
16033295|NCT02643095|Device|scleral contact lens|Scleral contact lens
16033296|NCT02643082|Drug|GFF MDI (PT003) 14.4/9.6μg|Glycopyrronium and Formoterol Fumarate
16033297|NCT02643082|Drug|Placebo MDI|Comparator: Placebo MDI which contains no active ingredients
16033298|NCT02643069|Other|Intervention Geriatric Program|The investigators will implemented programs to detected and manage care for older patients in four settings: Emergency room, oncology department, surgery departments making major surgery and Cardiology. The core intervention will consist of the following elements: comprehensive geriatric assessment, coordination with primary ans social care, integrated and continued care, access to rehabilitation facilities, management of drug treatment avoiding polypharmacy and stressing adherence.
16033300|NCT02643043|Other|Biospecimen Collection|Subjects consent to provide access to archival tumor tissue and whole blood samples for genetic analysis. Subjects also consent to the indefinite use of their specimens and linked clinical information for ongoing or future research related to metastatic urothelial cancer.
16033301|NCT02643030|Behavioral|hypercapnia|Tidal volume (6 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 45mmHg
16033302|NCT02643030|Behavioral|normocapnia|Tidal volume (10 ml/kg) and respiratory rate is adjusted to achieve the objective values of ETCO2 35mmHg
16033303|NCT02643017|Drug|Dexmedetomidine|Administration of dexmedetomidine at a rate 0.6 ug/kg/hr during surgery.
16033304|NCT02643017|Drug|normal saline|Administration of same amount of dexmedetomidine at a rate 0.6 ug/kg/hr during surgery.
16033305|NCT02643004|Device|Senofilcon A|contact lens
16033306|NCT02643004|Device|Stenfilcon A|contact lens
16033307|NCT02642991|Device|Phenacite|contact lens
16033308|NCT02642991|Device|comfilcon A|contact lens
16033309|NCT02642978|Procedure|RSRCLM|The Da Vinci Surgical System may help to overcome some of the difficulties of laparoscopy for complicated abdominal surgery. The aim of this study was to present an innovative technique that is robot-assisted, simultaneous radical resection of both colorectal cancer and liver metastasis (RSRCLM).
16033310|NCT02642978|Procedure|Open|Traditional open simultaneous radical resection of both colorectal cancer and liver metastasis
16033311|NCT02642965|Drug|Cytarabine|Given IT or IV
16033312|NCT02642965|Biological|Filgrastim|Given SC or IV
16033313|NCT02642965|Drug|Fludarabine Phosphate|Given IV
16033314|NCT02642965|Other|Laboratory Biomarker Analysis|Correlative studies
16033315|NCT02642965|Drug|Liposome-encapsulated Daunorubicin-Cytarabine|Given IV
16033316|NCT02642965|Other|Pharmacological Study|Correlative studies
16033317|NCT02642952|Other|non-invasive methods|To measure central hemodynamics and arterial stiffness by non-invasive methods using SphygmocoR (Atcor Medical, Sydney, Australia) before and after the procedure.
16033318|NCT02642939|Drug|Mifepristone|Mifepristone is an antagonist of the GR-II (glucocorticoid) receptor, yet has little affinity for the GR-I (mineralocorticoid) receptor. Mifepristone is also a potent antagonist at the progesterone receptor, and may block the androgen receptor to a limited degree.
16033319|NCT02642926|Procedure|Monopolar current|Hysteroscopic surgical treatment of menorrhagia by use of monopolar current
16033320|NCT02642926|Procedure|Bipolar current|Hysteroscopic surgical treatment of menorrhagia by use of bipolar current
16033321|NCT02642913|Drug|Enzalutamide|
16033322|NCT02642913|Drug|Enzalutamide with Sorafenib|
16033323|NCT02642900|Procedure|Photodynamic Therapy|evaluate the effectiveness of photodynamic therapy (PDT) in the treatment of denture stomatitis in complete denture wearers.
16033324|NCT02642900|Drug|Nystatin 100.000 units|Control group treated with nystatin
16033325|NCT02642887|Procedure|mTA + SCTG|These recession defects will be covered by modified tunnel approach; using a full thickness flap till the level of mucogingival junction then, partial thickness flap will be applied in the vestibular mucosa. SCTG will be harvested from the palate, put on the root surface then covered by the mTA and sutured.
16033326|NCT02642874|Drug|Methocarbamol|Methocarbamol twice daily
16033327|NCT02642874|Drug|Calcium Carbonate|Calcium carbonate twice daily
16033328|NCT02642861|Drug|Cyclobenzaprine|cyclobenzaprine administration for 2 weeks
16033329|NCT02642861|Drug|Calcium Carbonate|Calcium carbonate for 2 weeks
16033330|NCT02642848|Procedure|HTO with microfracture|High tibial osteotomy(HTO) with micro fracture on femoral condyle is an common treatment for the correction of malalignment of the knee treating osteoarthritis. Device: Tomofix
16033331|NCT02642848|Procedure|Transplantation of bone marrow stem cell|Transplantation of autologous bone marrow cell concentrate using BMAC collecting from iliac bone. Bone marrow cell cell 6cc
16033332|NCT02642848|Procedure|Transplantation of adipose derived stem cell|Transplantation of autologous adipose-derived stromal vascular fraction using LipoSculptor collecting from abdominal fat tissue. Adipose derived stem cell from abdominal fat tissue 3cc
16033333|NCT02642835|Procedure|vaginal wall mesh|retrospective review of case series
16033334|NCT02642809|Drug|Pembrolizumab|
16033335|NCT02642809|Radiation|Brachytherapy|
16033336|NCT02642809|Procedure|Endoscopic biopsy|
16033337|NCT02642809|Procedure|Computed tomography-guided biopsy|
16033338|NCT02642809|Procedure|Peripheral blood collection|
16033339|NCT02642796|Device|transcutaneous electric nerve stimulation|"The TENS device will be applied for treatment periods of 30-40 minutes. The electrodes will be connected to the TENS device are stimulated in modulation mode and the parameters will be adjusted as pulse width of 60 μs,frequency of 120 Hz and the stimulation intensity as high as the subject could tolerate.
~Electrodes will be placed on either lumbar and sciatic nerve tracing unilaterally or on either side or parallel to the surgical wound."
16033340|NCT02642783|Behavioral|Descriptive analysis|subjects were asked to assess the sensory profile by tasting the laxative bowel cleansing solutions, namely: Moviprep, picoprep, fortrans and isinova
16033548|NCT02641353|Drug|Apremilast Oral Suspension|30 mg oral suspension
16150697|NCT01775358|Drug|Placebo 0.15mg/kg|
16033341|NCT02642783|Behavioral|acceptability test|subjects were asked to assess the acceptability of the laxative bowel cleansing solutions, namely: Moviprep, picoprep, fortrans and isinova
16033342|NCT02642770|Device|Transesophageal echocardiography|2D LV Speckle tracking strain and 3D LVEF measurements
16033343|NCT02642757|Behavioral|AUDIT brief intervention|Intervention will be provided following the Chilean ministry of health implementation manual on the AUDIT associated brief intervention. The pamphlet on alcohol use will be provided to participants.
16033344|NCT02642757|Other|Pamphlet on alcohol use|Only the pamphlet on alcohol use will be provided (the same received by participants on the intervention group). This is not an active intervention based on the current literature.
16033345|NCT02642744|Other|Nursing care model|Subjects will be randomized into either the attending nursing model of care vs the standard nursing model
16033346|NCT02642718|Drug|Ketorolac Tromethamine|In the operating room, the anesthesiologist administered ketorolac (30 mg) in 50 mL of 0.9 % saline intravenously to patients in the ketorolac group 30 minutes before surgical incision (a single dose).
16033347|NCT02642718|Other|Placebo|In the operating room, the anesthesiologist administered 50 mL of 0.9 % saline intravenously to patients in the control group 30 minutes before surgical incision
16033348|NCT02642705|Other|High intensity interval training N|Exercise training and ambient air breathing
16033349|NCT02642705|Other|High intensity interval training H|Exercise training and hypoxic breathing
16033350|NCT02642705|Other|Constant load exercise training N|Exercise training and ambient air breathing
16033351|NCT02642705|Other|Constant load exercise training H|Exercise training and hypoxic breathing
16033352|NCT02642705|Other|Hypoxic conditioning at rest|Hypoxic breathing at rest
16033353|NCT02642705|Other|Normoxic conditioning at rest|Normoxic breathing at rest (placebo)
16033354|NCT02642692|Procedure|Patellar Tendon graft|Acl reconstruction with patellar tendon graft
16033355|NCT02642692|Procedure|Hamstring Graft|Acl reconstruction with hamstring graft
16033356|NCT02642679|Device|Opticell Ag|Opticell Ag+ applied to STSG donor site
16033357|NCT02642666|Behavioral|Children's Yoga|"Trained children's yoga instructors will guide the children through 30 minute yoga classes (in-person and on the yoga video), using a manualized curriculum from If I Was a Bird Yoga ™ with child centered themes. Each class will have a similar structure, set of poses, and breathing exercises, but the theme of the class will change every two weeks. The themes for the classes are ocean yoga adventure, jungle yoga adventure and outer space yoga adventure. The study participants will spend two weeks practicing the same theme at home and at school before moving on to the next theme."
16033358|NCT02642653|Drug|Lovastatin|Once per day dosing
16033359|NCT02642653|Other|Placebo|Once per day dosing
16033360|NCT02642640|Dietary Supplement|melatonin|5 mg of melatonin per os.
16033361|NCT02642640|Drug|placebo|
16033362|NCT02642627|Device|Bellafill|
16033363|NCT02642614|Drug|BI 1026706|
16033364|NCT02642614|Drug|Placebo|
16033365|NCT02642614|Drug|Placebo|For blinding purposes
16033366|NCT02642601|Drug|Indomethacin(KAHIRA PHARMA&CHEM,IND,CO.CAIRO-EGYPT)|one dose of indomethacin 100 mg rectal suppository 1- 2 hours before embryo transfer
16033367|NCT02642588|Dietary Supplement|energy gel|energy gel: gelatinous edible containing carbohydrates typically used during endurance races
16033368|NCT02642562|Drug|Ferric Derisomaltose|
16033369|NCT02642549|Behavioral|Girls for Health|"The G4H '1000 Hours' Bridge Program will offer English, science and math training, career workshops, opportunity to 'shadow' a health provider, a mentored safe space club to facilitate economic empowerment, training on gender equity and human rights, and communication/leadership skills. Cash transfers for vacations will be provided to support participation. Girls who receive 5 credits on their SSCE exams and pass the health training institute (HTI) entrance exam are eligible for admission. A Foundational Science Training (FST) program will be provided to the '1000 Hours' participants who gain admission to a HTI to strengthen their ability to the pass the HTI weeding exams. The FST will focus on English, math and science training, and safe spaces for social support development."
16033370|NCT02642536|Behavioral|MH MOVE|provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms to be used during 10 phone based clinician led CBT sessions
16033371|NCT02642536|Behavioral|Enhanced Usual Care|provides the standard MOVE! weight management program plus a workbook containing education for management of depression, anxiety and PTSD symptoms but not phone calls are provided.
16033372|NCT02642523|Drug|Nesiritide|Subjects will receive an intravenous infusion of recombinant human b-type natriuretic peptide (BNP) (Nesiritide) over 2 hours at 2 doses: 0.003 ug/kg/min for 1 hour, followed by 0.01 ug/kg/min for 1 hour. Nesiritide (Johnson and Johnson) is FDA-approved for the treatment of heart failure. Study investigators received approval from the FDA for an IND exemption for nesiritide in this study. While receiving the BNP infusion, subjects will also receive an intravenous infusion of normal (0.9%) saline over 2 hours. Subjects will receive a standardized high-salt diet for at least 6 days prior to this study visit.
16033373|NCT02642523|Drug|Insulin|The hyperinsulinemic-euglycemic insulin clamp, which will last between 2-2.5 hours, involves continuous intravenous infusions of human regular insulin and of dextrose solution. Simultaneously, subjects receive an intravenous infusion of normal (0.9%) saline over 2 hours. Subjects will receive a standardized high-salt diet for at least 6 days prior to this study visit.
16033374|NCT02642523|Other|Saline|Subjects will receive an intravenous infusion of normal (0.9%) saline over 2 hours at a rate of 0.25 ml/kg/min. Subjects will receive a standardized high-salt diet for at least 6 days prior to this study visit.
16033375|NCT02642510|Other|Structured Education DVD + Verbal Teaching|"The structured education DVD is a 15-minute DVD presentation of information about unit routines and activities; leukemia/lymphoma; treatment modalities and procedures; treatment of side effects; and participant and family members activities of importance to prevent infection and promote well-being during cancer treatment.
~Participants will also receive verbal educational teaching by their assigned nursing staff regarding information about leukemia and lymphoma, common treatments, and side effects."
16033376|NCT02642510|Other|Verbal Teaching|Participants will receive verbal educational teaching by their assigned nursing staff regarding information about leukemia and lymphoma, common treatments, and side effects.
16035342|NCT02628496|Procedure|KTP laser photoablation (standard of care)|
16033377|NCT02642497|Drug|intra-wound instillation of ketamine|intra-wound instillation of ketamine (1 mg/ kg) and normal saline in a total volume of 10 ml dispersed evenly throughout the wound; given after hemostasis and before wound closure
16033378|NCT02642497|Drug|intra-wound instillation of normal saline|intra-wound instillation of normal saline in a total volume of 10 ml dispersed evenly throughout the wound; given after hemostasis and before wound closure
16033379|NCT02642497|Drug|systemic administration of ketamine|intra-muscular administration of ketamine (1 mg/ kg), given before wound closure.
16033380|NCT02642484|Drug|Gabapentin|Gapapentin twice daily
16033381|NCT02642484|Drug|Calcium Carbonate|calcium carbonate twice daily
16033382|NCT02642471|Procedure|no systematic pelvic lymphadenectomy|systematic pelvic lymphadenectomy is omitted in surgical treatment
16033383|NCT02642445|Device|Renal Sympathetic Denervation|We applied a ablation catheter for discrete radiofrequency ablations of 8 W or less and lasting up to 2 min each to obtain up to four-six ablations separated both longitudinally and rotationally from the adventitia
16033384|NCT02642432|Drug|ABT-493/ABT-530|Tablet; ABT-493 coformulated with ABT-530
16033385|NCT02642419|Drug|Rivaroxaban and single antiplatelet drug (aspirin, clopidogrel or prasugrel)|"Rivaroxaban will be orally administered after a meal at a dose of 15 mg if the creatinine clearance (CLcr) is 50 mL/min or more and at a dose of 10 mg if the CLcr is 15-49 mL/min (regardless of time)
~Antiplatelet will be selected from aspirin or thienopyridine derivatives (clopidogrel or prasugrel)
~Aspirin will be orally administered once a day at a dose of 81 mg or 100 mg
~Clopidogrel will be orally administered once a day after a meal at a dose of 75 mg. The dose will be reduced to 50mg once a day depending on age, body weight or clinical findings.
~Prasugrel will be orally administered once a day at a dose of 3.75 mg. If the body weight is 50kg or less a reduced dose(2.5 mg once a day) will be considered depending on the age, renal function or other bleeding and thrombotic risk."
16033386|NCT02642419|Drug|Rivaroxaban|Rivaroxaban will be orally administered at a dose of 15 mg if the creatinine clearance (CLcr) is 50 mL/min or more and at a dose of 10 mg if the CLcr is 15-49 mL/min.
16033387|NCT02642393|Drug|Inosine|capsules containing 500 mg of inosine
16033388|NCT02642393|Drug|Placebo|capsules containing ~500 mg of lactose and appearing indistinguishable from inosine capsules
16033389|NCT02642380|Drug|Dexamethasone (4 cycles)|dexamethasone 40mg daily for 4 consecutive days every 14 days for 4 courses
16033390|NCT02642380|Drug|Dexamethasone (1 cycle)|dexamethasone 40mg daily for 4 consecutive days
16033391|NCT02642367|Device|McGrath videolaryngoscope|without use of stylet
16033392|NCT02642367|Device|McGrath videolaryngoscope with Intubating stylet (Mallinckrodt)|use of stylet
16033393|NCT02642367|Drug|rocuronium|tracehal intubation was performed 2 min after rocuronium injection with McGrath videolaryngoscope
16033394|NCT02642328|Other|HIIT Training|Circuit of high intensity interval training (HIIT) with Strength and Power Exercises for 4 minutes (20 sec of stimulus / 10 sec rest)
16033395|NCT02642328|Other|Control|Continuous aerobic exercise at 65% of VO2Max
16033396|NCT02642315|Drug|Horizant|"Phase1: During phase 1 therapy, Horizant will be added on as an adjunct to all subjects taking part in the study along with stable dose of their current dopaminergic (DA) agent and both medication will be continued for a total period of 90 days from day 0 to day 90. Subjects will be evaluated for three visits (days 0, 30 and 90) during Phase I.
~Phase 2: At the 90th day follow-up visit, with initiation of phase 2 therapy, all subjects will be tapered off (by 50% reduction in dose each week) of their current dopaminergic agents while maintaining the same dose of Horizant and will be on Horizant monotherapy. All subjects will be evaluated for additional three clinic visits (days 120, 180, 360)."
16033397|NCT02642302|Behavioral|HIIT With 60 sec Rest|30 sessions of High intensity interval training (all out) with 30 seconds of stimulous with 60 seconds rest on VO2Max and aerobic/ anaerobic performance
16033398|NCT02642302|Behavioral|HIIT With120 sec Rest|30 sessions of High intensity interval training (all out) with 30 seconds of stimulous with 120 seconds rest on VO2Max and aerobic/ anaerobic performance
16033399|NCT02642302|Behavioral|Control|Continuous exercise at 50-55% VO2Max with similar total work of interval training
16033400|NCT02642289|Dietary Supplement|Lactobacillus acidophilus|"Probiotic 5000, a commercial probiotic product provided by the company Complementos Fitonutricionales, S.L."
16033401|NCT02642289|Dietary Supplement|Lactobacillus Rhamnosus GG ®|"Ergyphilus confort, a commercial probiotic product provided by the nutritional supplements lab Laboratorios Nutergia"
16033402|NCT02642289|Other|Placebo|Innocuous substance
16033403|NCT02642276|Other|Exercise training|Patients to be randomized to the 'maximal walking group' or 'submaximal group' will undergo exercise training sessions 3 times per week for a period of 12 weeks.
16033404|NCT02642263|Drug|Carbetocin|Postpartum uterotonic drug
16033405|NCT02642250|Drug|Metronidazole|The data will be recorded for physical examination including gender , age, height, weight, temperature, heart rate ,respiratory rate and blood pressure of the subject, number of stool per day, stool with or without mucus or mixed with blood along with abdominal cramps, dehydration, nausea, vomiting and related clinical information will be carefully recorded. Statistical tools and tabulated results will be used to identify the similarities and differences in safety, efficacy and tolerability of treatment.
16033406|NCT02642250|Drug|Entoban|To evaluate the safety and efficacy of coded herbal formulation (Entoban) through randomized clinical study and compared with Metronidazole DS for treatment of gastrointestinal infections for improving the health of the community with due regard to the prevalence of disease and the feasibility of using alternative treatments.
16033407|NCT02642237|Biological|Fluenz|intranasal inoculation with Fluenz
16033408|NCT02642237|Other|placebo|
16033409|NCT02642237|Other|LPS|
16033410|NCT02642224|Behavioral|Social Work Case Management|The National Network of Hospital Violence Intervention (NNHVI) suggests that intervening when gunshot victims are receiving treatment in hospital trauma services may be effective in linking high-risk individuals to appropriate case management services, and that this service linkage may lower the risk of further violence. Our adaptation of the NNHVI model will focus on the social networks of gunshot victims as well as the victims themselves. Intervention efforts will range from job training and mentoring to relocation to different communities.
16033454|NCT02641899|Drug|ITCA 650 20/60 mcg/day|ITCA 650 osmotic mini pump delivering exenatide 20 mcg/day for 14 days, followed by ITCA 650 osmotic mini pump delivering exenatide 60 mcg/day.
16033411|NCT02642211|Procedure|cataract surgery|Eyes (one eye per patient) randomized to either phacoemulsification and intraocular lens insertion or small incision cataract surgery and intraocular lens insertion
16033412|NCT02642198|Device|Surveyor S12 and S19 patient monitor|Non-invasive blood pressure measurement
16033413|NCT02642185|Procedure|Microwave ablation|CT-guided percutaneous ablation of 1-5, <31mm in diameter, colorectal liver metastases, performed with any generic microwave ablation system cleared for clinical use
16033414|NCT02642185|Procedure|Resection|Open or laparoscopic resection of liver metastases using standard of care surgical procedures
16033415|NCT02642172|Dietary Supplement|ITF (Inulin/OFS 75/25)|Participants will consume 16 g/day ITF
16033416|NCT02642172|Dietary Supplement|Placebo|Participants will consume 16 g/day maltodextrin
16033417|NCT02642159|Drug|Alirocumab|Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector.
16033418|NCT02642159|Drug|Statins|Statins at stable dose without other LMT as clinically indicated.
16033419|NCT02642159|Drug|Ezetimibe|Pharmaceutical form: tablet Route of administration: oral
16033420|NCT02642159|Drug|Fenofibrate|Pharmaceutical form: tablet Route of administration: oral
16033421|NCT02642159|Drug|Nicotinic acid|Pharmaceutical form: tablet Route of administration: oral
16033422|NCT02642159|Drug|Omega-3 fatty acids|Pharmaceutical form: tablet Route of administration: oral
16033423|NCT02642159|Drug|Antihyperglycemic Drug|Insulin (injectable or inhaled) or other antihyperglycemic drugs as clinically indicated.
16033424|NCT02642146|Drug|Calcium Channel Blockers|
16033425|NCT02642146|Drug|Phosphodiesterase Inhibitors|
16033426|NCT02642146|Drug|Endothelin receptor blocker|
16033427|NCT02642146|Drug|Prostanoids|
16033428|NCT02642146|Drug|Other vasodilator|
16033429|NCT02642133|Procedure|Lingual Frenotomy and/or maxillary labial frenectomy|The procedure is performed with a 1064nm InGaAsP semiconductor diode laser which is a soft tissue laser with variable pulsed wave and wattage settings. The procedure was performed at 0.7-0.8 pulsed watts, 200 microseconds on and 100 microseconds off (actual wattage: 0.47 to 0.53 W) using a 300 micron laser fiber. The tongue is elevated using a grooved director while the laser tip is applied to the frenulum. If present, the anterior frenulum is divided until the submucosal portion of the tie is identified (this is the posterior tongue-tie). A small window in the central mucosa is made and the lateral mucosal walls of the posterior tongue-tie are released, taking care to not disturb the fascia of the underlying genioglossus muscle.
16033430|NCT02642120|Device|"Dental device Laboraide"|"After giving consent, randomization will be carried out using sealed envelopes. After randomization women will be offered to withdraw consent. Women assigned to the study group will receive a sealed Laboraide™ package.
~Labor follow up will be documented regularly including outcome. The use of the DSD will not affect the regular management of labor according to the routine standards of the delivery suite. Following delivery, patients will be asked to complete a satisfaction questionnaire."
16033431|NCT02642107|Radiation|Elective neck irradiation|Whole neck irradiation is given in the positive neck. Elective neck irradiation of Level II,III,Va lymph node area is given in negative neck, and Level IV,Vb and Supraclavicular fossa lymph node area were not irradiated in negative neck.
16033432|NCT02642107|Radiation|Whole neck irradiation|Whole neck irradiation is given regardless of negative neck or positive neck
16033433|NCT02642094|Drug|Rapamycin|Low dose of rapamycin at 2 mg/day for -5-7 days of treatment
16033434|NCT02642055|Behavioral|Neuro+ Attention Training|Attention training program with Neuro+ software
16033435|NCT02642055|Other|Treatment as Usual|Continuation of current ADHD treatment
16033436|NCT02642042|Drug|Docetaxel|Given IV
16033437|NCT02642042|Other|Laboratory Biomarker Analysis|Correlative studies
16033438|NCT02642042|Drug|Trametinib|Given PO
16033439|NCT02642029|Device|Excitatory TMS|Single session of intermittent theta-burst stimulation (600 pulses in blocks of 2s, separated by 8s of pause) to cerebellar vermis.
16033440|NCT02642029|Device|Inhibitory TMS|Single session of continuous theta-burst stimulation of 600 pulses to cerebellar vermis.
16033441|NCT02642029|Device|Sham TMS|Single session, using the exact same procedures as the active arms but with a sham coil, which is designed to induce the same nonspecific sensory effects of TMS (auditory and somatosensory activation) without inducing the neuromodulatory magnetic fields.
16033442|NCT02642016|Biological|CDX-0158 (formerly known as KTN-0158)|Single agent CDX-0158 until unacceptable toxicity or progressive disease
16033443|NCT02642003|Drug|Granulocyte Colony Stimulating Factor|
16033444|NCT02641990|Drug|ITCA 650 20/60 mcg/day, ITCA placebo|ITCA 650 osmotic mini pump delivering exenatide 20/60 mcg/day and Levora® for 28 days, followed by ITCA osmotic mini pump delivering placebo and Levora® for 28 days
16033445|NCT02641990|Drug|ITCA placebo, ITCA 650 20/60 mcg/day|ITCA osmotic mini pump delivering placebo and Levora® for 28 days, followed by Levora® and ITCA 650 osmotic mini pump delivering exenatide 20/60 mcg/day and Levora® for 28 days
16033446|NCT02641951|Other|Stellate ganglionic block|Ultrasound guided stellate ganglionic block
16033447|NCT02641951|Other|Pecs II block|Ultrasound guided Pecs II block
16033448|NCT02641938|Drug|Dexmedetomidine|Dexmedetomidine group :1ug/kg IV loading over 20 minutes followed by 0.5ug/kg/hr IV infusion after induction of anesthesia until the completion of the surgery
16033449|NCT02641938|Drug|Normal Saline|Control group :IV loading and infusion of same volume of normal saline after induction of anesthesia until the completion of the surgery
16033450|NCT02641925|Procedure|Omentum preserving|The minimum volume of omentum (within 3cm from gastroepiploic vessel) will be removed during gastrectomy with lymph node dissection.
16033451|NCT02641925|Procedure|Total omentectomy|Whole omentum will be removed during gastrectomy with lymph node dissection.
16033452|NCT02641912|Other|Biotene mouthwash|During supervised product use: Participants will rinse with 15 mls of mouthwash for 30 seconds and spit out. No rinsing with water immediately after product usage is permitted. At Home use:Participants will rinse with 15 mls of mouthwash for 30 seconds and spit out. A maximum of two doses can be used per day.
16033453|NCT02641912|Other|Mineral Water|"During supervised product use:Participants will take a dose (drink) of one measured sip of 15mls of water.
~At Home use: Participants can sip (drink) water as often as required. Participants will be consuming their own water for home use."
16033460|NCT02641886|Drug|Jian Pi Yi Shen Hua Tan Granules|Jianpi Yishen Huatan Granules contain Herba cistanche，Fructus Alpinia Oxyphyllae，Rhodiola rosea, Polygala tenuifolia willd and Coptis chinensis.Jianpi Yishen Huatan Granules dissolved in water of 100 ml ,po, bid of each 90-days cycle. Number of treatment cycles: one
16033461|NCT02641886|Other|the placebo group|Treat with the placebo which contain 5% of prescription of Jian Pi Yi Shen Hua Tan Granules and 95% dextrin.The placebo dissolved in water of 100 ml ,po, bid of each 90-days cycle. Number of cycles: one
16033462|NCT02641873|Drug|BBI608|240 mg twice daily (480 mg total daily dose)
16033463|NCT02641873|Drug|5-FU|400 mg/m2 bolus will be administered intravenously immediately following irinotecan/levofolinate infusion, followed by 1200 mg/m2/day (total 2400 mg/m2) continuous infusion per cycle(14 days).
16033464|NCT02641873|Drug|Irinotecan|180 mg/m2 together with levofolinate will be administered intravenously per cycle(14 days).
16033465|NCT02641873|Drug|Levofolinate|200 mg/m2 together with Irinotecan will be administered intravenously per cycle(14 days).
16033466|NCT02641873|Drug|Bevacizumab|5 mg/kg will be administered intravenously following irinotecan/levofolinate infusion per cycle(14 days).
16033467|NCT02641860|Biological|Mesenchymal progenitor cells|Biological: Allogenic Adipose tissue-derived mesenchymal progentior cells administrated for intra-articular use
16033468|NCT02641847|Drug|docetaxel|
16033469|NCT02641847|Drug|doxorubicin or epirubicin|
16033470|NCT02641847|Drug|cyclophosphamide|
16033471|NCT02641847|Drug|gemcitabine|
16033472|NCT02641847|Drug|cisplatin|
16033473|NCT02641834|Other|Vegetarian diet|7-days dietary profile with an isocaloric Vegetarian diet for 3 months
16033474|NCT02641834|Other|Mediterranean diet|7-days dietary profile with an isocaloric Mediterranean diet for 3 months
16033475|NCT02641821|Drug|Nifedipine GITS|
16033476|NCT02641808|Other|follicular flushing|Depending on randomisation the follicle is not flushed (group A) or flushed adapted to follicule size (16mm 2ml, 18mm 3ml, and 20mm 4ml etc.) up to five times with (e.g.flushing media with heparin (SynVitro® Flush, Origio, Berlin, Germany). The flushings are collected each in a separate collecting tube (group B). The analysis of the collected oocytes is performed in the IVF lab.
16033477|NCT02641808|Other|no follicular flushing|
16033478|NCT02641795|Device|Minimally invasive robotic cochlear implantation|
16033479|NCT02641782|Drug|antibody ch14.18|17.5mg/m²d 10-20h i.v, d4-7 in cycles 1,3,5 and d8-11 in cycles 2,4.
16033480|NCT02641782|Drug|GM-CSF|250µg/m²xd, d1-14 s.c. or i.v (2h) in cycles 1,3,5
16033481|NCT02641782|Drug|IL-2 i.v.|3.0 mio U/m²xd d1-4 continuous infusion i.v. and 4.5 mio U/m²xd d8-11 continuous infusion i.v. in cycles 2,4
16033482|NCT02641782|Drug|IL-2 s.c.|0.06 mio U/m² i.v. test dosis for 30min. i.v. at least 2h before first subcutaneous (s.c.) application. 6 mio U/m²xd d1-5 and 8-12 s.c. in cycles 2,4
16033483|NCT02641782|Drug|Retinoic acid|160mg/m²xd b.i.d.oral d 11-24 in cycles 1,3,5,6 and d15-28 in cycles 2,4
16033484|NCT02641769|Biological|Stem Cell Transplantation|intervention with transplantation of autologous purified stem cells
16033485|NCT02641756|Other|treatment interruption after in depth sampling under CART|The participants will undergo in depth sampling under CART to characterise the HIV reservoir in different anatomical compartments. Subsequently an experimental viral rebound, by a brief therapy stop, will help us identify the clinically relevant viral reservoir by doing phylogenetic analysis on the rebounding virus and on the virus found in the different compartments under CART.
16033486|NCT02641743|Dietary Supplement|Inslow|carbohydrate adjusted liquid food using palatinose as the major carbohydrate (>50%)
16033487|NCT02641743|Dietary Supplement|standard balanced formula|
16033488|NCT02641730|Drug|Guselkumab|Participants will receive two or one syringe of guselkumab 100 mg subcutaneously at Week 0, 4, 12 and every 8 weeks thereafter through Week 60 in group 1 or 2. Group 3a or 3b participants will receive two or one syringe of guselkumab 100 mg at Week 16, 20 and every 8 weeks thereafter through Week 60.
16033489|NCT02641730|Drug|Placebo|Participants in group 1 will receive placebo at Week 16. Participants in group 2 will receive placebo at Week 0, 4, 12, 16, 20 and every 8 weeks thereafter through Week 60. Participants in group 3 will receive placebo at Week 0, 4, 12, then at Week 16, 20 and every 8 weeks thereafter through Week 60 for group 3b.
16033490|NCT02641717|Other|vaginal swab|
16033491|NCT02641704|Behavioral|Multidisciplinary program|Coordinated multidisciplinary program
16033492|NCT02641691|Radiation|Radiation|
16033493|NCT02641691|Drug|Oxaliplatin|
16033494|NCT02641691|Drug|Leucovorin|
16033495|NCT02641691|Drug|Fluorouracil|
16033496|NCT02641678|Device|Implantation of cardiac monitor|In patients with kryptogenic stroke, a cardiac monitor was implanted to detect atrial fibrillation
16033497|NCT02641665|Procedure|Cardiac valve surgery|Aortic or mitral valve replacement/repair performed in isolation of in addition to coronary artery bypass graft(s).
16033498|NCT02641652|Drug|Sertraline|25 mg once daily for first 7 days, then 50 mg once daily for the rest of the trial
16033499|NCT02641652|Drug|Placebo|1/2 tablet once daily for first 7 days, then 1 tablet once daily for the rest of the trial
16033500|NCT02641639|Drug|Fosbretabulin tromethamine|CA4P is a synthetic phosphorylated prodrug of CA4, a naturally occurring derivative of the South African willow tree, combretum caffrum. CA4P targets pre-existing tumor vasculature, resulting in an acute, reversible reduction in TBF that leads to central necrosis within tumors.
16033501|NCT02641639|Drug|Placebo|Saline for infusion
16033502|NCT02641626|Procedure|Urgent Coronary Angiography|Diagnostic test for the evaluation of the coronary vasculature.
16033503|NCT02641626|Procedure|Deferred Coronary Angiography|Diagnostic test for the evaluation of the coronary vasculature.
16033504|NCT02641613|Procedure|retroclavicular block|retroclavicular block for forearm or hand surgery
16033505|NCT02641613|Procedure|supraclavicular block|supraclavicular block for forearm or hand surgery
16033506|NCT02641600|Device|Elastic stockings|Use of elastic stockings to alleviate patient symptoms
16033507|NCT02641600|Device|Placebo stockings|Placebo stocking with pressure applied to the legs
16033508|NCT02641587|Other|CHTP 1.2|Ad libitum use of the CHTP 1.2 for 5 days in confinement followed by 85 days in an ambulatory setting.
16033549|NCT02641340|Drug|Fentanyl Sublingual Spray|Fentanyl delivered at low, medium and high doses by sublingual spray (FSS)
16033509|NCT02641587|Other|CC|Ad libitum use of subject's own preferred non-menthol brand of CC for 5 days in confinement followed by 85 days in an ambulatory setting.
16033510|NCT02641574|Other|compare complication|
16033511|NCT02641561|Drug|Indomethacin|Indomethacin is a non-steroidal anti-inflammatory drug (NSAID) which is commonly used to reduce inflammation caused by gout, osteoarthritis and rheumatoid arthritis. It acts by blocking the cyclo-oxygenase 1 and 2 (COX) receptors. It has also been implicated to prevent post-ERCP pancreatitis
16033512|NCT02641561|Drug|Lactated Ringer's Solution|Lactated ringer's solution (LR), is an intravenous fluid (IVF) used commonly during endoscopic procedures and operative procedures. It's composition is similar to that of humans including sodium, chloride, potassium, calcium and lactate. Studies have implicated the use of this fluid in pancreatitis treatment and prevention of post-ERCP pancreatitis
16033513|NCT02641561|Drug|Normal Saline|standard IVF would include 0.9% normal saline (NS) solution used during all endoscopic procedures. 0.9% NS includes equal parts sodium and chloride.
16033514|NCT02641561|Drug|Placebo|Placebo would be a suppository 50 mg x 2
16033515|NCT02641548|Device|Sock of silicone|
16033516|NCT02641548|Other|Heel cream|
16033517|NCT02641535|Other|exercise under hot and humid conditions protocol|"acclimatization day protocol: 2 hour effort performed in a climatic chamber, which include walk on a treadmill at 5 Km/h on a 2% incline under heat conditions (40 deg. centigrade & 40% RH) Core (rectal) and skin temperature and heart rate will be monitored continuously
~experiment days (2 days): 2 hour effort (2 cycles of: 50 min walk and 10 min rest-sitting) performed in a climatic chamber, which include walk on a treadmill at 5 Km/h on a 2% incline under heat conditions (35 deg. centigrade & 60% RH) Core (rectal) and skin temperature and heart rate will be monitored continuously."
16033518|NCT02641535|Device|BC membrane protective garment|
16033519|NCT02641535|Device|NBC mask|
16033520|NCT02641522|Drug|Siltuximab|Single infusion of siltuximab (11 mg/kg)
16033521|NCT02641509|Device|NBI during polypectomy|NBI to perform the polipectomy
16033522|NCT02641509|Device|no NBI during polypectomy|no NBI to perform the polypectomy
16033523|NCT02641496|Behavioral|CBT-OSA|CBT-OSA is a new cognitive behavioral therapy which focuses on changing behaviors and thoughts to help individuals adjust to using a CPAP machine.
16033524|NCT02641496|Behavioral|Sleep Education|The Sleep Education treatment will include information, facts, and videos on sleep, cardiovascular disease, PTSD, and proper sleep hygiene.
16033525|NCT02641483|Other|Electrical Rectal Stimulation|Electrical stimulation of the rectum will be applied to activate sensory afferent neurons of the rectum and evoke a recto-colonic reflex to improve colonic motility. This intervention will compared to individuals' usual mechanical intervention of digital rectal stimulation.
16033526|NCT02641470|Dietary Supplement|DA9301 (Vaccinium uliginosum extract)|
16033527|NCT02641470|Dietary Supplement|Placebo|
16033528|NCT02641457|Drug|Aflibercept|12 eyes received an intraocular injection of 2.00 mg of aflibercept (IA) and IOP were measured by tonometer. The neovascularization was evaluated by biomicroscope.
16033529|NCT02641457|Drug|Ranibizumab|12 eyes received an intraocular injection of 1.25mg ranibizumab and IOP were measured by tonometer. The neovascularization was evaluated by biomicroscope.
16033530|NCT02641444|Procedure|Blood plasma collection|Approximately 3mL of blood will be taken from each subject just prior to the colonoscopy.
16033531|NCT02641444|Procedure|Cervical and Vaginal Biopsy|2 biopsies each will be collected from the vaginal wall and the cervix
16033532|NCT02641444|Procedure|Colonoscopy with Ileal and Rectal Biopsy|10 biopsies each will be collected from the rectum and terminal ileum from each subject during the colonoscopy.
16033533|NCT02641431|Procedure|mapping/ablation|Mapping/ablation procedures will be performed under general anesthesia. After femoral venous access and percutaneous epicardial access, a multipolar catheter will be positioned at the right ventricle apex. High-density endocardial and epicardial electroanatomical maps will be performed using the CARTO3 system to define areas of delayed fragmented prolonged potentials during stable sinus rhythm and during spontaneous or ajmaline-induced type 1 BrS ECG pattern. Ajmaline (1mg/Kg in 5 minutes) will be used for the provocative test. Complete endo and epicardial maps will be obtained to ensure reconstruction of a 3-dimensional geometry of the cardiac chambers and to identify areas of abnormal electrograms as characterized by prolonged fragmented ventricular signals
16033534|NCT02641431|Drug|Ajmaline|Epicardial mapping will be performed before and after ajmaline (1mg/Kg in 5 minutes).
16033535|NCT02641431|Procedure|ablation|Radiofrequency will be delivered on areas of the abnormal electrograms using an externally irrigated 3.5-mm tip ablation catheter.
16033536|NCT02641431|Procedure|mapping|A re-map focusing on the targeted area will be obtained after ablation. Re-mapping and ajmaline reinfusion will be used to confirm the elimination of all the abnormal electrogram and BrS-ECG pattern disappearance.
16033537|NCT02641418|Other|Supervised exercise programme|supervised exercise programme
16033538|NCT02641405|Device|Equistasi|Equistasi is a nanotechnology for proprioceptive focal stimulation. Every patient will receive three patches to be placed at C7 and at the gastrocnemial junction of both legs.
16033539|NCT02641405|Device|Inactive Equistasi|Inactive Equistasi will be given to every patient in the form of three patches to be placed at C7 and at the gastrocnemial junction of both legs.
16033540|NCT02641392|Drug|GED-0301|Mongersen
16033541|NCT02641392|Other|Placebo|Placebo
16033542|NCT02641379|Drug|Peginterferon alfa-2a|PEG-IFN is available as 180 microgram (mcg) per 0.5 mL, prefilled syringe and pen for single dose sc. injection\n
16033543|NCT02641379|Drug|Ribavirin|Ribavirin is available as 200 mg tablets
16033544|NCT02641366|Device|Electromagnetic tracking|The electromagnetic tracking system will precisely measure the position of a patient's upper extremity in space during routine neurologic examination.
16033545|NCT02641366|Procedure|Tremor kinetics after DBS|We will fit the patient with the electromagnetic sensors and then perform routine outpatient neurologic examinations with their DBS system in both the DBS on and the DBS off settings.
16033546|NCT02641366|Procedure|Tremor kinetics before and after DBS|We will perform two testing sessions: the first session will be performed during a routine preoperative visit, the second session will be performed during a routine postoperative DBS programming visit in both the DBS on and the DBS off settings.
16033547|NCT02641353|Drug|Apremilast Tablet|30 mg tablet
16033550|NCT02641340|Drug|Fentanyl Citrate IV|Fentanyl Citrate 50 mcg, delivered intravenously
16033551|NCT02641327|Device|EarlySense (Passive monitoring)|Passive contact-free monitoring
16033552|NCT02641314|Drug|metronomic therapy|"Propranolol 0.5 mg/kgxd p.o. day 1,
~mg/kgxd p.o. day 2,
~mg/kgxd p.o. day 3-365 (maximum total daily dose: 120 mg) divided in 2 doses per day
~Celecoxib 400 mg/m2xd p.o.; day 1-365 (maximum total daily dose: 800 mg) divided in 2 doses per day
~Cyclophosphamide cycle 1, day1: loading dose: 500 mg/m2 intravenous 1-h-infusion, single dose day 2-365 25 mg/m2xd p.o (maximum total daily dose: 50 mg) as single daily dose
~Vinblastine 3 mg/m2xd i.v. (maximum total daily dose: 6 mg) administered day 1 and 15 (every two weeks) as single daily dose
~Etoposide 25 mg/m2xd p.o.; day 1-21 weeks 1-3, 9-11, 17-19, 25-27 (maximum total daily dose: 50 mg) as single daily dose"
16033553|NCT02641301|Drug|Sustained release morphine sulfate, 30 mg|A single oral administration of a capsule of sustained release morphine sulfate, 30 mg, on one day.
16033554|NCT02641288|Drug|Ropivacaine irrigation|Using a standard irrigation device (no specific device is being used), 300 mg total of ropivacaine in 200ml normal saline will be instilled into the abdomen after surgical dissection, just before abdominal wall closure. Under direct visualization, the solution is delivered over the oesophageal hiatus, over both anastomoses and in both subdiaphragmatic spaces.
16033555|NCT02641288|Drug|Normal saline irrigation|Using a standard irrigation device (no specific device is being used), 200ml normal saline will be instilled into the abdomen after surgical dissection, just before abdominal wall closure.
16033556|NCT02641275|Other|Structured self-management-training|Structured self-management-training (incl. systemic analysis, coaching, teaching) in 4 sessions
16033557|NCT02641249|Device|Vibration|A device providing vibrations is placed on the subject and vibration is turned on and off in a 6 hour on/off sequence. Heart rate, respiratory pauses and oxygen saturation are compared during vibration (intervention) and without vibration (no intervention) in the same subject.
16033558|NCT02641236|Drug|Vancomycin-polymyxin B|
16033559|NCT02641223|Device|spinal cord stimulator|Pt asked to wear FitBit device prior to and after spinal cord stimulator placement.
16033560|NCT02641210|Procedure|Periodontal Treatment|Periodontal Treatment using Gracey curettes and ultrasonic device.
16033561|NCT02641210|Drug|Albendazole|All participants took Albendazole 400 mg before the intervention.
16033562|NCT02641197|Device|AngioDefender|"Repeatability will be assessed by repeat AngioDefender (AD) testing of the same subject 1 hour apart, using the same AD device and operator.
~Reproducibility will be assessed by comparing FMD scores obtained for the same subject, but using different AD devices and operators."
16033563|NCT02641171|Other|Specimen sampling|exhaled air samples blood samples fecal samples
16033564|NCT02641158|Other|Control Group|"After screening HCV antibody positive, participants will receive an appointment and reminder card to return for their HCV RNA results. If HCV RNA positive, study staff will attempt to make an appointment for the participant's next step in the HCV continuum. If a participant attends the next step visit, the participant would be subject to whatever is the local standard of care at that clinic/agency from that point forward."
16033565|NCT02641158|Behavioral|Care Facilitation Group|"The same will occur for intervention participants, yet an HCV care facilitator will motivate them to return for their HCV RNA results; appointment reminders will be made prior to the next step visit; follow-up contact will be made for missed appointments; and the HCV care facilitator will coordinate and link the participant to available community resources (e.g., mental health, housing agencies) by scheduling appointments, arranging transportation, and helping to complete any clinic registration (or other) paperwork that agencies may require to access services."
16033566|NCT02641145|Radiation|F-18 florbetapir/C-11 acetate PET|F-18 florbetapir PET scan, C-11 acetate PET scan
16033567|NCT02641145|Device|MRI|Cardiac MRI with gadolinium contrast.
16033568|NCT02641145|Radiation|N-13 ammonia PET|N-13 ammonia PET scan following supine bicycle stress.
16033569|NCT02641132|Drug|Mitomycin C 0.02%|Pterygium excision with application of mitomycin C
16033570|NCT02641132|Procedure|Pterygium surgery|Two different procedures- excision of the head and the body and excision of the head only
16033571|NCT02641106|Other|Video Directly Observed Therapy|Video Directly Observed Therapy (VDOT) is a novel means of remotely observing patients ingesting medications using videos sent from a smartphone. VDOT was developed and found to be feasible and acceptable for monitoring daily treatment of active TB in San Diego, CA and Tijuana, B.C., Mexico (R21-AI088326; PI: R. Garfein). Patients are taught how to use the VDOT recording app, record medication ingestion, and contact their physician when side effects occur. Participants are trained at the time of their first LTBI treatment dose to ensure participants know how to record videos. All remaining 11 weekly doses are taken and recorded wherever the participant chooses. Clinic staff monitor videos as they arrive using a password protected website and document each medication dose that is taken.
16033572|NCT02641106|Other|In-Person DOT|Clinic-based, in-person DOT is the standard of care for monitoring adherence for patients taking the 12-dose isoniazid/rifapentine treatment for LTBI. Participants visit the clinic once weekly until all 12 doses are taken or 16 weeks pass, whichever comes first.
16033573|NCT02641093|Drug|Pembrolizumab|Pembrolizumab administered one week prior to surgery and then every three weeks in the adjuvant setting for a total of 7 doses.
16033574|NCT02641093|Procedure|Surgery|gross total surgical resection
16033575|NCT02641093|Radiation|Radiation Therapy|60-66 Gy over 6 weeks
16033576|NCT02641093|Drug|Cisplatin|Weekly during radiation therapy for 6 doses only for patients with high risk pathological features
16033577|NCT02641080|Drug|Aspirin|If there is evidence that aspirin alone is equivocal to using both the pumps and aspirin, this could lower health care cost and burden for patients undergoing total joint arthroplasty while establishing that the rate of DVT/PE does not increase with the absence of the compression device.
16033578|NCT02641080|Device|Portable Compression Device|If there is evidence that aspirin alone is equivocal to using both the pumps and aspirin, there could be lower health care cost and burden for patients undergoing total joint arthroplasty while establishing that the rate of DVT/PE does not increase with the absence of the compression device.
16033579|NCT02641067|Drug|Doravirine|Following an overnight fast, a single coated tablet of 100 mg doravirine will be administered orally
16033580|NCT02641054|Drug|CVXL-0107|
16033581|NCT02641054|Drug|Placebo|
16033582|NCT02641054|Drug|Levodopa|
16151135|NCT01771614|Behavioral|Exercise|
16033588|NCT02640989|Biological|Seasonal trivalent influenza vaccine, Anflu®|Seasonal trivalent influenza vaccine manufactured by Sinovac Co., Ltd.
16033589|NCT02640989|Biological|Seasonal trivalent influenza vaccine, VAXIGRIP|Seasonal trivalent influenza vaccine manufactured by PasteurSanofi Pasteur
16033590|NCT02640989|Biological|Seasonal trivalent influenza vaccine, Fluarix|Seasonal trivalent influenza vaccine manufactured by GlaxoSmithKline Biologicals
16033591|NCT02640976|Drug|Human menopausal gonadotrophin (HMG)|[Merional® 75 IU ampoules, IBSA institut]
16033592|NCT02640976|Drug|GnRH antagonist Cetrorelix|[Cetrotide® 0.25 mg syringes, Merck Serono]
16033593|NCT02640976|Drug|Human chorionic gonadotrophin (hCG)|[Choriomon® 5000 IU ampoules, IBSA institut]
16033594|NCT02640963|Other|Exercise|to determine the feasibility of the GrACE (Group Aged Care Exercise) programme in RAC, with the secondary objective of measuring the programme benefits on gait speed, sit to stand and handgrip strength.
16033595|NCT02640963|Other|Control|to compare with the GrACE (Group Aged Care Exercise) programme in RAC, as well as the secondary objective of measuring the programme benefits on gait speed, sit to stand and handgrip strength against the intervention group
16033596|NCT02640950|Device|NeuroStar TMS|Transcranial Magnetic Stimulation
16033597|NCT02640924|Radiation|Proton radiotherapy|
16033598|NCT02640924|Procedure|Radiofrequency Ablation|
16033599|NCT02640898|Radiation|docetaxel-based chemoradiotherapy|experimental:Patients with Zubrod performance status (PS) of 0-2 received up to 2 21-day cycles of pre- and post-radiation chemotherapy (docetaxel 37.5 mg/m2 on days 1 and 8, cisplatin 25 mg/m2 on days 1-3, and a continuous infusion of fluorouracil (FU) 750 mg/m2 on days 1-5), respectively. CCRT between pre- and post-radiation chemotherapy was initiated on day 43 and consisted of 3-dimensional conformal intensity-modulated radiation therapy (45 Gy) plus concurrent docetaxel 20 mg/m2 weekly for 6 weeks;
16033600|NCT02640898|Radiation|FU-based chemoradiotherapy|The adjuvant treatment consisted of 425mg/m2 of bolus fluorouracil(5-FU) per day, 20 mg/m2 of leucovorin (LV), per day, for 5 days, followed by 45Gy of radiation with current 5-FU ( 400mg/m2 ) and LV (20mg/m2) as an intravenous bolus on each of of the first four days and the last three days of irradiation. One month after the completion of radiotherapy, two 5-day cycles of 5-FU and FV chemotherapy were given one month apart.
16033601|NCT02640885|Device|Foley's cather ballon|
16033602|NCT02640846|Drug|Norepinephrine|Norepinephrine will be given to the patient due to septic shock. After the inclusion we will change the dose of Norepinephrine to achieve 3 different MAP-levels, 60 mmHg, 75 mmHg and 90 mmHg.
16033603|NCT02640846|Drug|Milrinone|Corotrope will be given and after 30 minutes of treatment the cardiac function will be assessed with echocardiography and systemic hemodynamics.
16033604|NCT02640846|Drug|Levosimendan|Levosimendan will be given and after 30 minutes of treatment the cardiac function will be assessed with echocardiography and systemic hemodynamics.
16033605|NCT02640833|Drug|Duvelisib|Duvelisib will be taken continuously. This is a defining dose study, therefore the dose of Duvelisib may change.
16033606|NCT02640833|Drug|Venetoclax|Venetoclax will be taken continuously. This is a defining dose study, therefore the dose of Venetoclax will change.
16033607|NCT02640820|Drug|Sensitizing DPCP Ointment|Sensitization
16033608|NCT02640820|Drug|Treatment DPCP Ointment|Treatment
16033609|NCT02640807|Drug|Interleukin-7|IM (intra-muscular) administration of CYT107 recombinant glycosylated human IL-7 (SC administration for patients with INR (International Normalized Ratio) >2.5 or platelet count < 35,000
16033610|NCT02640807|Drug|Placebo|IM administration of Placebo (SC administration for patients with INR>2.5 or platelet count < 35,000
16033611|NCT02640794|Drug|Clopidogrel|Clopidogrel therapy will start within 24 hrs before the TAVI procedure in cases where a transfemoral approach is used and within 24 hrs after the TAVI procedure in cases where a transapical approach is used. The initial dose of clopidogrel will be of 300 mg followed by 75 mg/die. The duration of clopidogrel treatment will be of 3 months.
16033612|NCT02640794|Drug|Aspirin|Aspirin/acetylsalicylic acid (80-325 mg/d). Aspirin/acetylsalicylic acid therapy will start at least 24 hrs before the TAVI procedure and continued for at least 6 months.
16033613|NCT02640781|Procedure|self-expandable metal stent insertion(covered stent)|Stent insertion was performed by experienced endoscopists under fluoroscopy and by using through-the-scope methods. After the obstructing tumor was identified by endoscopy, a guidewire was introduced through the stricture under endoscopic and fluoroscopic controls. Then, the self-expandable colorectal covered stent delivery catheter was advanced through the working channel of the endoscope over the guidewire until the stent was positioned across the stricture. Upon releasing the stent delivery catheter, stent deployment was initiated proximally and progressed distally. Simple abdominal radiography was performed during and after the procedures to confirm proper stent placement and expansion.
16033614|NCT02640781|Procedure|self-expandable metal stent insertion(uncovered stent)|Stent insertion was performed by experienced endoscopists under fluoroscopy and by using through-the-scope methods. After the obstructing tumor was identified by endoscopy, a guidewire was introduced through the stricture under endoscopic and fluoroscopic controls. Then, the self-expandable colorectal stent delivery uncovered catheter was advanced through the working channel of the endoscope over the guidewire until the stent was positioned across the stricture. Upon releasing the stent delivery catheter, stent deployment was initiated proximally and progressed distally. Simple abdominal radiography was performed during and after the procedures to confirm proper stent placement and expansion.
16033615|NCT02640768|Other|educational training|implementation of a structured educational program for physicians and nurses
16033616|NCT02640755|Drug|[14C]AZD2014|Radiolabelled dual TORC1/TORC2 inhibitor
16033617|NCT02640755|Drug|Multiple dose AZD2014|Dual TORC1/TORC2 inhibitor
16033618|NCT02640755|Drug|Fulvestrant|Hormonal Agent
16033619|NCT02640755|Drug|Paclitaxel|Taxane
16033620|NCT02640729|Drug|Nelotanserin|once daily, oral, 20-mg tablets
16033621|NCT02640729|Drug|Placebo|once daily, oral, matching tablets
16033655|NCT02640443|Drug|Sulfamethoxazole|60 mg sulfamethoxazole per kg bodyweight (maximal of 3g) divided in 2 doses per day during 3 weeks
16033656|NCT02640430|Device|standard treatment|20 minutes, twice a day for 10 sessions
16033657|NCT02640430|Device|Free Aspire|20 minutes, twice a day for 10 sessions
16033658|NCT02640417|Drug|Nucleotides + B12|Oral treatment with either Nucleotides + Vitamin B12
16151136|NCT01771614|Procedure|Hyperglycemia|
16033622|NCT02640716|Behavioral|multi-domain internet-based adaptive training program|The cognitive training will be a multi-domain adaptive training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. Specific training paradigms include a time perception task, visual search task, attention blink, delayed mapping task, attention span task, Go-No go task, Stroop task, task switching, and name-face match task, among others. To maintain task difficulty, the tasks will be grouped based on the task difficulty in each domain. Furthermore, each task will have various difficulty levels.
16033623|NCT02640716|Behavioral|placebo program|For the control group, tasks for processing speed and attention are included. Importantly, a fixed, primary difficulty level for all participants in the control group is set.
16033624|NCT02640703|Biological|Infanrix + Prevenar 13|Different time of application
16033627|NCT02640677|Biological|4CMenB|This study is strictly observational; Administration of BEXSERO, the schedule of office visits and all treatment regimens will be determined by the treating health care provider in the context of routine clinical care.
16033630|NCT02640651|Device|DC-Stimulator (PLUS version)|transcranial direct current stimulation
16033631|NCT02640638|Behavioral|CenteringPregnancy|8-12 pregnant women whose due dates are in the same month will receive ten 2-hour group prenatal care sessions according to the standard curriculum provided by the Centering Healthcare Institute.
16033632|NCT02640625|Dietary Supplement|Probiotic compound|Lactobacillus rhamnosus GG, Lactobacillus acidophilus, Lactobacillus bulgaricus, Bifidobacterium animalis subsp. lactis, and Streptococcus thermophilus.
16033633|NCT02640612|Drug|BI 695501|
16033634|NCT02640599|Other|Vestibular Rehabilitation + Aerobic Exercise|Subjects in the experimental group will undergo traditional Vestibular Rehabilitation as well as participate in an aerobic exercise training program.
16033635|NCT02640599|Other|Vestibular Rehabilitation|The control group will receive standard care which includes participation in vestibular physical therapy treatments 1-2 times per week.
16033636|NCT02640586|Device|three MR examination|Three MR examinations: first MRI taken within 1 week before preoperative chemo-radiotherapy; second MRI taken between 14-16days after the initiation of radio-chemotherapy; third MRI taken 7-9 weeks after the completion of preoperative chemo-radiotherapy.
16033637|NCT02640573|Drug|Hydroxyurea|Treat symptomatic HbSC patients to MTD on hydroxyurea, and assess for clinical improvement using the AdultsQLTM 3.0 Sickle Cell Disease Module after 6 months at MTD, compared to entrance scores
16033638|NCT02640560|Other|Food allergy questionnaire|The Parents of the cases children will compile a questionnaire including questions about general information on the family, on life and food habits, on indoor environment, on health status, on clinical aspects of the allergy, on the access to diagnostic and treatment resources
16033639|NCT02640560|Other|Control Questionnaire|The Parents of the control children will compile a questionnaire including questions about general information on the family, on life and food habits and on indoor environment.
16033640|NCT02640534|Drug|Enzalutamide|Enzalutamide 160 mg od until disease progression
16033641|NCT02640534|Drug|Metformin|850 mg bid until disease progression
16033642|NCT02640521|Behavioral|Chart Reminders & New York State Quit line referral system|Investigators at New York University Medical School, Bellevue and Lincoln Hospital will work closely to (1) develop chart reminders appropriate for each of their clinics (2) to prompt providers to ask about in home smoking at every medical visit and (3) to establish a New York Quit line referral system in the pediatric practice, including clearly defined roles and responsibilities for each step. The New York State Quit line service includes proactive telephone calls with mailings of self-help material, free nicotine replacement therapy for those who qualify, and referrals to local treatment programs, ensuring that health literacy levels of materials is maximized, amending the training curriculum for providers as necessary, and modifying patient education materials that are part of the provider tool kit to focus on the negative impact of secondhand smoke.
16033643|NCT02640508|Drug|Eribulin|Will be given by I.V. at 1.4 mg/m2 on day 1 and day 8.
16033644|NCT02640508|Drug|Lenvatinib|Will be taken orally at 20-24 mg daily in each 21 day cycle.
16033645|NCT02640495|Drug|Intravenous Artesunate as part of standard medical practice|Intravenous Artesunate 2.4 mg/kg
16033646|NCT02640482|Drug|ABT-493/ABT-530|Tablet; ABT-493 coformulated with ABT-530
16033647|NCT02640482|Drug|Placebo for ABT-493/ABT-530|tablet
16033648|NCT02640469|Other|Chlorhexidine with water rinse|"This procedure will be followed for both the right and left hands and arms:
~scrub each side of finger, in between fingers and back and front of hands for 2 minutes, followed by scrubbing of arms, keeping hands higher than arms at all times, wash each side of the arms from wrist to elbow for 1 minute"
16033649|NCT02640469|Other|Chlorhexidine without water rinse|Scrub each side of finger, in between fingers and back and front of hands for 2 minutes, proceed to scrub the arms, keeping the hand higher than the arm at all times, wash each side of the arms from wrist to elbow for 1 minute, and repeat the process on the other arm.
16033650|NCT02640469|Other|Chlorhexidine + sterillium hand rub|Scrub each side of finger, in between fingers and back and front of hands for 2 minutes, Scrub each side of finger, in between fingers and back and front of hands for 2 minutes, proceed to scrub the arms, keeping the hand higher than the arm at all times, wash each side of the arms from wrist to elbow for 1 minute, and repeat the process on the other arm. Rinse hands and arms by passing through water in one direction, dry hands, and rub 5 mL of alcohol into the palm of the hands, forearms and elbows. Ensure that the whole skin area on both arms is covered.
16033651|NCT02640456|Biological|Bacteriology|Tonsillar surface swabs, tonsillar tissues, and pus aspirates.
16033652|NCT02640456|Procedure|Type of surgery|Surgical approach and complications.
16033653|NCT02640456|Biological|Biochemistry|Amylase concentration i pus aspirates.
16033654|NCT02640456|Biological|Serology|Levels of antibodies against selected bacteria (F. necrophorum, F. nucleatum, and Group A streptococci) in acute and convalescent sera.
16033659|NCT02640417|Drug|B Vitamins|Oral treatment with vitamins B1, B6, and B12
16033660|NCT02640404|Biological|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine|0.5 mL, Intramuscular. 2 doses 3 months apart
16033661|NCT02640404|Biological|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine|0.5 mL, Intramuscular.
16033662|NCT02640391|Other|colonoscopy|
16033663|NCT02640378|Other|NO intervention|This study was a cross-sectional study. It had no intervention.
16033664|NCT02640365|Drug|MM-398|unresectable Advanced non-colorectal cancer
16033665|NCT02640365|Drug|Irinotecan|unresectable metastatic colorectal cancer
16033666|NCT02640365|Drug|Leucovorin (LV)|unresectable metastatic colorectal cancer
16033667|NCT02640365|Drug|5-fluorouracile (5-FU)|unresectable metastatic colorectal cancer
16033668|NCT02640365|Drug|bevacizumab|unresectable metastatic colorectal cancer
16033669|NCT02640365|Drug|MM-398|unresectable metastatic colorectal cancer
16033670|NCT02640352|Dietary Supplement|Probi Defendum|
16033671|NCT02640352|Dietary Supplement|Placebo|
16033672|NCT02640326|Other|No Foley Urinary Catheter|No Foley urinary catheter will be put in place during the operation
16033673|NCT02640326|Other|Standard of care Foley urinary catheter insertion|A Foley urinary catheter will be put in place during the operation
16033674|NCT02640313|Drug|18F-choline PET-MR imaging|Dynamic and static 18F-choline PET-MR imaging
16033675|NCT02640300|Drug|Clozapine|Switching to clozapine with immediate or gradual antipsychotic discontinuation
16033676|NCT02640287|Biological|Blood or bone marrow samples|
16033677|NCT02640274|Behavioral|Nurse-led counselling programme|The intervention is an individual nurse-led counselling programme in addition to usual care. The intervention includes 3 outpatient clinic visits (at weeks 2, 14 and 26) and two telephone calls (at weeks 4 and 16) by a cardiovascular nurse during the first 6 months early discharged. The counselling focuses on cardiac risk reduction behaviour based on guidelines issued by European Society of Cardiology and self-management support.
16033678|NCT02640274|Other|Usual care|
16033680|NCT02640235|Device|CELSTAT|
16033681|NCT02640235|Device|Surgicel Original|
16033682|NCT02640222|Drug|VKA|
16033683|NCT02640222|Drug|Apixaban|
16033684|NCT02640222|Drug|dabigatran|
16033685|NCT02640222|Drug|rivaroxaban|
16033686|NCT02640209|Biological|CART 19|The target dose range administered in this study is 1-5x108 CART-19 cells administered via split dosing: 10% on Day 1 (1-5x107 CART19), 30% on Day 1 (3x107-1.5x108 CART19), 60% on Day 2 (6x107-3x108 CART19).
16033687|NCT02640196|Device|Macintosh|The participants intubated the easy airway simulator with a double lumen tube using the Macintosh laryngoscope followed with intubating the difficult airway simulator
16033688|NCT02640196|Device|GlideScope|The participants intubated the easy airway simulator with a double lumen tube using the GlideScope followed with intubating the difficult airway simulator
16033689|NCT02640196|Device|Airtraq|The participants intubated the easy airway simulator with a double lumen tube using the Airtraq followed with intubating the difficult airway simulator
16033690|NCT02640196|Device|King Vision|The participants intubated the easy airway simulator with a double lumen tube using the King Vision followed with intubating the difficult airway simulator
16033691|NCT02640183|Drug|EMLA|
16033692|NCT02640183|Other|Placebo|
16033693|NCT02640170|Other|Registry|
16033694|NCT02640157|Drug|ABT-493/ABT-530|Tablet; ABT-493 coformulated with ABT-530
16033695|NCT02640157|Drug|Sofosbuvir|Tablet
16033696|NCT02640157|Drug|Daclatasvir|Tablet
16033697|NCT02640144|Drug|Sodium Hyaluronate 1%|Intra articular knee injection following arthroscopy
16033698|NCT02640144|Drug|Placebo|Intra articular knee injection following knee arthroscopy. Serves as a placebo. This is the actual buffer of the ARTHREASE injection.
16033699|NCT02640131|Behavioral|Biomedical Component|Bio-medical: The bio-medical component includes an appointment with urologist pre-operatively and 5 follow-up appointments. Patients/partners are provided instruction on the use of pro-erectile agents/devices.
16033700|NCT02640131|Behavioral|Psychosocial Component|Psychosocial: aims to support maintenance of intimacy, pro-erectile therapy use, and regular satisfying sexual activity. At each time point, participants receive standardized sexual health counselor (SexHC) counseling and manualized support.
16033701|NCT02640131|Behavioral|Attention Control|Couples will attend 30-minute clinic consultations with an Urologist and a Survivorship Counsellor (SurvC) at 3-4, 7-8, and 12-13 months post radical prostatectomy (RP). Couples will receive a Kegel Exercise booklet and receive appointment-specific chapters of the Challenging Prostate Cancer: Nutrition, Exercise, and You (CPC) manual (a patient self-help manual written by the Princess Margaret Prostate Centre team). The core topics discussed during the counselling sessions include: preparation for immediate post-RP recovery, Kegel exercises, nutrition and prostate cancer (PC), exercise and PC, and maintaining healthy lifestyle change.
16033702|NCT02640118|Drug|Lixisenatide|single injection of 20 µg lixisenatide subcutaneously
16033703|NCT02640118|Drug|Lixisenatide-Placebo|
16033704|NCT02640118|Other|Standardized liquid meal|standardized liquid meal (200 ml containing 1,650 kJ (394 kcal): carbohydrate 50%, protein 15%, fat 35%, consisting of glucose (48.4 g + 1.6 g [U-13C6]-glucose), rapeseed oil (14.1 g), whey protein (15.2 g) and 1.5 g paracetamol).
16033705|NCT02640105|Other|Neurological clinical examination|Diagnostic and description of cluster headache
16033706|NCT02640105|Other|Psychological clinical examination|Scale and questionnaires
16033707|NCT02640105|Other|Questionnaires|Psychopathological and cognitive questionnaires
16033708|NCT02640105|Other|Blood sample|Blood sample for DNA collection
16033709|NCT02640105|Other|Endothelial function measurement|Endothelial function will be measured with a noninvasive Peripheral Arterial Tone (PAT) signal technology using the EndoPAT device
16033710|NCT02640092|Drug|[18F]GTP1|Participants will receive [18F]GTP1 as per the schedule specified in the arm description.
16033711|NCT02640079|Behavioral|Cognitive behavioral therapy|
16033712|NCT02640066|Other|acupuncture|
16033713|NCT02640053|Procedure|Cryotherapy|Applied topically
16033714|NCT02640053|Drug|Paclitaxel|Given IV
16033717|NCT02640040|Device|llizarov external fixation device|llizarov external fixation device was applied to fix the tibia.
16033718|NCT02640040|Device|intramedullary rod fixation|retrograde intramedullary rod was applied to stabilize the tibia.
16033719|NCT02640040|Procedure|surgery|combined surgery for enrolled patients with CPT: sleeve resection of the pathological soft tissues, retrograde intramedullary rodding, packaged lilac bone autograft,and llizarov external fixation device installation.
16033720|NCT02640027|Procedure|Cast removal at home using a telemedicine tool|Instead of receiving follow up treatment in a clinical setting, patients randomized to the arm of the study requiring telemedicine will receive some of their follow up care at home.
16033721|NCT02640014|Dietary Supplement|Milk|Milk Oral immunotherapy
16033722|NCT02639975|Drug|PBF-677|once daily oral administration
16033723|NCT02639975|Drug|Placebo|once daily oral administration
16033724|NCT02639962|Radiation|Cardiac CT|Cardiac CT before the CAG, and follow up after 2 month and 12 month
16033725|NCT02639949|Behavioral|Cognitive-behavioral adherence promotion program|A culturally sensitive group cognitive behavioral therapy combined with adherence promotion.
16033726|NCT02639949|Behavioral|Standard Care|
16033727|NCT02639923|Procedure|Drawing of 7ml peripheral blood|puncture peripheral vein
16033728|NCT02639910|Biological|Tafasitamab|tafasitamab (MOR208) dose: 12 mg/kg intravenous infusion
16033729|NCT02639910|Drug|Idelalisib|idelalisib dose: 150 mg twice daily orally
16033730|NCT02639910|Drug|Venetoclax|venetoclax dose: 400 mg once daily orally
16033731|NCT02639897|Other|Direct Laryngoscopy|Tracheal intubation with direct laryngoscopy using Macintosh laryngoscope blade
16033732|NCT02639884|Device|SedLine EEG|
16033733|NCT02639884|Device|RRa monitoring|
16033734|NCT02639858|Drug|Docetaxel-PM|Docetaxel PM 75mg/m2 IV infusion
16033735|NCT02639832|Device|LiquidBiopsy®, NK VueTM|The LiquidBiopsy® device will test for cells with tumor cell markers in blood. The genetic sequence of DNA recovered samples will be studied. Using NK VueTM researchers will test for NK cell activity.
16033736|NCT02639819|Drug|ɛ-Aminocaproic Acid|Intervention: intravenous ε-Aminocaproic Acid within 3 hours of symptom onset
16033737|NCT02639806|Drug|Sevoflurane|
16033738|NCT02639806|Drug|Lidocaine|
16033739|NCT02639793|Procedure|catheter ablation|Three different catheter ablation techniques will be used aimed at isolating the pulmonary veins from left atrium.The endpoint is defined as absence or dissociation of all pulmonary vein potentials as confirmed by the circular mapping catheter after a waiting period of 30 minutes after the last ablation. The use of adenosine or isoproterenol to detect concealed pulmonary vein conduction is voluntary.
16033740|NCT02639780|Other|protein expression pattern of packed red blood cells|the proteome of packed red blood cells will be assessed at predefined time points
16033741|NCT02639767|Drug|Pemetrexed/Cisplatin|Dose escalation of pemetrexed and cisplatin will follow the dose levels. The escalation will not exceed 500 mg/m^2 for pemetrexed in combination with 75 mg/m^2 of cisplatin even if the maximum tolerated dose is not identified. Each treatment cycle of chemotherapy will be 21 days. Patients will receive up to 2 cycles of chemotherapy during the radiation, and be followed for any DLT during the radiation therapy and for 12 weeks afterwards.
16033742|NCT02639767|Radiation|Pleural Intensity Modulated Radiation Therapy|Pleura intensity modulated radiation therapy (IMRT) will be administered over approximately 6 weeks at 50.4 Gy in 28 fractions. The prescription radiation dose may anywhere between 45 and 50.4 Gy in 25 fractions if necessary to meet the normal tissue dose constraints.
16033743|NCT02639767|Device|MRI|A pre-treatment MRI before chemo-RT will be acquired and will be used for target delineation. A three month post-treatment MRI will be acquired with the same protocol to assess the response from concurrent chemo-RT.
16033744|NCT02639754|Behavioral|Social Network Leader Endorsement|Leaders of social networks will attend a multi-session intervention during which they will be trained to deliver messages endorsing frequent HIV testing, compliance with medical guidelines, and adherence to medical treatment regimens to friends. Additionally, these leaders will be trained on how to deliver effective messages.
16033745|NCT02639754|Behavioral|HIV Counseling|At the baseline session, participants in this condition will receive counseling about the benefits and availability of HIV care and the importance of frequent HIV testing.
16033746|NCT02639741|Drug|Melatonin|Preoperative melatonin tablet will be given and postoperative pain scores will be evaluated
16033747|NCT02639741|Drug|Vitamin C|Preoperative vitamin C tablet will be given and postoperative pain scores will be evaluated
16033748|NCT02639741|Other|Placebo|Preoperative placebo tablet will be given and postoperative pain scores will be evaluated
16033749|NCT02639728|Other|Regular Coffee|Regular coffee will be given a 4oz cup three times daily and will be instructed to consume all of its liquid contents.
16033750|NCT02639728|Other|Decaffeinated coffee|Decaffeinated coffee will be given a 4oz cup three times daily and will be instructed to consume all of its liquid contents.
16033751|NCT02639728|Other|Warm water|Warm water will be given a 4oz cup three times daily and will be instructed to consume all of its liquid contents.
16033752|NCT02639702|Drug|Clozapine|Switching from twice-daily to once-daily clozapine dosing regimen
16033753|NCT02639689|Device|WALKAIDE|"A clinical evaluation will be conducted at T0 with achievement of the following tests without orthosis and with the usual orthosis if applicable: he will be made a stimulation test of common peroneal nerve and settings Walkaide® device.
~Subjects will be reconvened at T1, one to four weeks after the initial assessment to ensure the stability of walking speed. We will perform the following tests without orthosis and with the usual orthosis if applicable. The final evaluation (T2) will be 28 days after the start of the port of the device."
16033754|NCT02639676|Other|Diffusion Lung Capacity (DLCO), Vascular Challenge, Video Imaging, Specimen Collections|
16033755|NCT02639663|Device|dental device|"Leboride
~Post-partum primi and multiparous women whom are interested in breastfeeding and have not begun yet. This arm will be randomized into 2 groups
~Intervention group: participants will receive the dental device and be instructed to use it during breastfeeding.
~Control group: participants will not receive any device for breastfeeding pain control
~Post-partum women that have already begun breast feeding, will receive the dental device and each woman will be serve as her own control (breastfeeding before and after the use of the dental device."
16035416|NCT02627950|Drug|Metoclopramide|10 mg MCP intravenously
16033756|NCT02639650|Drug|Etoposide|etoposide 100mg/m2 ivgtt started at the first day of cycle, two weeks a cycle
16033757|NCT02639650|Drug|actinomycin D|actinomycin D 500ug ivgtt, started at the first day of cycle, two weeks a cycle
16033758|NCT02639650|Drug|methotrexate|methotrexate 100mg/m2, 200mg/m2, ivgtt, tetrahydrofolic acid （FA) 15mg q12h*4(24h after methotrexate injection),started at the first day of cycle, two weeks a cycle
16033759|NCT02639650|Drug|vincristine|vincristine 1mg/m2 started at the 8th day of cycle, two weeks a cycle
16033760|NCT02639650|Drug|cyclophosphamide|cyclophosphamide 600mg/m2, started at the 8th day of cycle, two weeks a cycle
16033761|NCT02639650|Drug|Paclitaxel|paclitaxel 135mg/m2, started at the first day of cycle, two weeks a cycle
16033762|NCT02639650|Drug|Cisplatin|cisplatin 50mg/m2, started at the first day of cycle, two weeks a cycle
16033763|NCT02639650|Drug|Carboplatin|carboplatin area under curve (AUC)=4-5, started at the first day of cycle, two weeks a cycle,as a substitute drug for cisplatin
16033764|NCT02639637|Drug|Sitagliptin|Subjects will receive sitagliptin 100 mg daily for 7 days prior to one of the study days.
16033765|NCT02639637|Drug|Placebo|Subjects will receive a placebo capsule daily for 7 days prior to one of the study days.
16033766|NCT02639637|Drug|Neuropeptide Y|During the study days, neuropeptide Y will be infused through an intra-arterial line. There will be four doses of neuropeptide Y used (0.1, 0.3, 1.0, and 3.0 nmol/min) and each dose will be infused for 10 minutes.
16033767|NCT02639637|Drug|Enalaprilat|Ninety minutes after the last dose of neuropeptide Y, enalaprilat will be infused through the intra-arterial line at 0.33 µg/min/100mL of forearm volume. After 30 minutes, a second infusion of neuropeptide Y will begin. Similar to the previous neuropeptide infusion, four doses of neuropeptide Y will be used (0.1, 0.3, 1.0, and 3.0 nmol/min) and each dose will be infused for 10 minutes.
16033768|NCT02639637|Drug|Valsartan 160mg|Valsartan 160 mg/d for 7 days prior to one of the study days.
16033769|NCT02639624|Drug|Low bicarbonate dialysate First|
16033770|NCT02639624|Drug|Normal bicarbonate dialysate First|
16033771|NCT02639624|Drug|Normal bicarbonate dialysate|
16033772|NCT02639624|Drug|Low bicarbonate dialysate|
16033773|NCT02639611|Other|Immediate Post Operative Acupuncture Treatment|acupuncture treatment immediately after surgery (twice a week for 6 weeks)
16033774|NCT02639611|Other|No Acupuncture Treatment|no acupuncture treatment for 6 weeks, but offered acupuncture at the end of the 6 week study period.
16033775|NCT02639598|Drug|Flunarizine|"as in arm descriptions"
16033776|NCT02639598|Drug|Topiramate|"as in arm descriptions"
16033777|NCT02639585|Drug|Daclinza and Sunvepra|direct acting antiviral agent against to hepatitis C virus
16033778|NCT02639572|Biological|Siloss® bone graft|The osseous defect was debrided of granulation tissue and the root surface was planed to remove plaque and calculus, until a smooth hard consistency was found. The defect's architecture was confirmed by direct observation and classified based on number of bony walls present. In patients selected for test group, in addition to open flap debridement (OFD), Siloss® bone replacement graft was utilized to fill the defects to the most coronal level of the osseous walls. The required amount of composite alloplast (Siloss®) was dispensed into a sterile dappen dish and mixed with patients own blood and carried to the defect site with an amalgam carrier. The mucoperiosteal flaps were repositioned and secured in place using interrupted sutures. The surgical procedure in control site included open flap debridement followed by placement of hydroxyapatite graft (G-graft®, Saharanpur, UP, India). The surgical area was protected and covered using a periodontal dressing. Randomization was employed.
16033779|NCT02639572|Biological|Hydroxyapatitie Bone graft|The osseous defect was debrided of granulation tissue and the root surface was planed to remove plaque and calculus, until a smooth hard consistency was found. The defect's architecture was confirmed by direct observation and classified based on number of bony walls present. In patients selected for test group, in addition to open flap debridement (OFD), Siloss® bone replacement graft was utilized to fill the defects to the most coronal level of the osseous walls. The required amount of composite alloplast (Siloss®) was dispensed into a sterile dappen dish and mixed with patients own blood and carried to the defect site with an amalgam carrier. The mucoperiosteal flaps were repositioned and secured in place using interrupted sutures. The surgical procedure in control site included open flap debridement followed by placement of hydroxyapatite graft (G-graft®, Saharanpur, UP, India). The surgical area was protected and covered using a periodontal dressing.Randomization was employed.
16033780|NCT02639559|Drug|BL-8040|
16033781|NCT02639559|Procedure|Leukapheresis|
16033782|NCT02639559|Procedure|Hematopoietic cell transplant|
16033783|NCT02639546|Drug|Cobimetinib|Cobimetinib tablet or suspension will be administered as per the schedule described in arm description.
16033784|NCT02639533|Drug|Pregabalin|Pregabalin 150 mg PO, single dose.
16033785|NCT02639533|Other|Placebo|Pill of same physical characteristics as the one used for the intervention, containing starch only. Administered PO in single dose.
16033786|NCT02639520|Drug|Canephron® N|2 tablets 3 times a day for 7 days
16033787|NCT02639520|Drug|Fosfomycin trometamol|1 sachet of 8 g of granules; one single dose on Day 1
16033788|NCT02639520|Drug|Canephron® N-placebo|2 tablets 3 times a day for 7 days
16033789|NCT02639520|Drug|Fosfomycin trometamol-placebo|1 sachet of 8 g of granules; one single dose on Day 1
16033790|NCT02639507|Procedure|Vitrectomy|
16033791|NCT02639494|Device|Self-Centering Guide Catheter|
16033792|NCT02639481|Behavioral|Standard physiotherapy|Classical standard physiotherapy, including measures to verticalize patients by means of orthesis, classical tilt tables, or castings
16033793|NCT02639481|Device|Erigo®Pro group without FES|Use of the Erigo®Pro device to verticalize patients to above 60° while performing robotic stepping leg movements. FES ist not used.
16033794|NCT02639481|Device|Erigo®Pro group with FES|Use of the Erigo®Pro device to verticalize patients to above 60° while performing robotic stepping leg movements. FES is applied during then whole treatment session, providing electrical stimulation to the muscles of the upper and lower leg, synchronous to the robotic stepping movements
16033795|NCT02639468|Device|Stroke Volume estimation using electrical impedance tomography|
16033843|NCT02639078|Drug|Placebo Comparator|One time dosing in capsule formulation
16033844|NCT02639065|Drug|Durvalumab|1500 mg IV every 4 weeks (1 cycle) for a maximum 13 doses (12 months), or until unacceptable toxicities or disease recurrence.
16033796|NCT02639455|Behavioral|Exercise|Participants will exercise 4 days per week, 20 minutes per session for 5 weeks (a total of 400 minutes). Exercise will be independent (with the goal of 85% of max effort for at least 2 minutes each session) and consist of running, jumping jacks, sit ups, push ups, or burpees depending on the participant's comfort and skill.
16033797|NCT02639442|Device|ClearRing™|
16033798|NCT02639429|Drug|Vaginal Misoprostol|
16033799|NCT02639429|Device|Foley Balloon + Vaginal Misoprostol|
16033800|NCT02639416|Dietary Supplement|Polymeric formula|Polymeric formulae are recommended in the management of inflammatory bowel disease in children
16033801|NCT02639416|Dietary Supplement|Elemental formula|Elemental formulae are recommended in cow's milk and other food intolerances in children.
16033802|NCT02639416|Other|Standard management|Standard management with F-100 and/or RUTF
16033803|NCT02639403|Radiation|Conformal three-dimensional Radiotherapy|Conformal three-dimensional RT was planned (3D-RT) using the Oncentra-Masterplan treatment planning system (Nucletron B.V., Veenendaal, Netherland). Short course RT (total, 25 Gy; 5 fraction in 5 days) will be delivered with an isocentric four-field box technique.
16033804|NCT02639390|Device|Robotic Therapy|Subjects will be placed in the robot and practice common upper extremity tasks involving grasping, manipulating and moving objects.
16033805|NCT02639390|Other|Conventional Therapy|An occupational therapist will provide one-on-one individualized programs focused on arm function. Treatment will focus on practice of specific tasks, such as reach, grasp, transport and release of various objects between different targets. Progression is done by varying the shape, size and weight of objects, altering the end range of the target or increasing the speed of movement.
16033806|NCT02639377|Drug|Chlorhexidine gluconate|
16033807|NCT02639377|Drug|Placebo|Solution chemical manufactured to mimic 0.12% chlorhexidine mouthwash
16033808|NCT02639364|Device|Nellcor Puritan Bennett 840 ventilator system|Puritan Bennett 840 ventilator can provide the VCV,PCV,Bi-level Airway Pressure Ventilation-airway Pressure Release Ventilation(BILEVER-APRV) mode.
16033809|NCT02639351|Biological|Investigational MenC-CRM adjuavnted with 12.5 ug of LHD153R|Intramuscular (IM) vaccination of 1 dose of 0.5 mL
16033810|NCT02639351|Biological|Investigational MenC-CRM adjuavnted with 25 ug of LHD153R|IM vaccination of 1 dose of 0.5 mL
16033811|NCT02639351|Biological|Investigational MenC-CRM adjuavnted with 50 ug of LHD153R|IM vaccination of 1 dose of 0.5 mL
16033812|NCT02639351|Biological|Investigational MenC-CRM adjuavnted with 100 ug of LHD153R|IM vaccination of 1 dose of 0.5 mL
16033813|NCT02639351|Biological|Meningococcal C-CRM Conjugate Vaccine (MenC-CRM)|IM vaccination of 1 dose of 0.5 mL
16033814|NCT02639338|Drug|SOF/VEL/VOX|400/100/100 mg FDC tablet administered orally once daily with food
16033815|NCT02639338|Drug|SOF/VEL|400/100 mg FDC tablet administered orally once daily without regard to food
16033816|NCT02639286|Drug|ISIS 304801|300 mg of ISIS 304801 administered as SC
16033817|NCT02639286|Drug|Placebo|Placebo administered via SC
16033820|NCT02639260|Drug|N-acetyl-mannosamine (ManNAc)|dose escalation
16033821|NCT02639247|Drug|SOF/VEL/VOX|400/100/100 mg FDC tablet administered orally once daily with food
16033822|NCT02639247|Drug|SOF/VEL|400/100 mg FDC tablet administered orally once daily without regard to food
16033823|NCT02639234|Biological|Vigil™|Upon completion of nivolumab infusion, subjects will receive Vigil™, 1.0 x 10^7cells via intradermal injection on Day 1 every 14 days for a minimum of 4 and a maximum of 12 doses depending on quantity of Vigil™ manufactured from surgical specimens.
16033824|NCT02639234|Drug|Nivolumab|Prior to Vigil™, subjects will receive nivolumab 3 mg/kg by intravenous infusion over 60 minutes on Day 1 every 14 days. If nivolumab is administered beyond 12 months it will be administered off study.
16033825|NCT02639221|Drug|PXT002331|
16033826|NCT02639208|Other|PatientsLikeMe (PLM)|
16033827|NCT02639195|Other|Treatment|Retrospective chart review of patients treated with manual therapy.
16033828|NCT02639182|Drug|AGS-16C3F|Intravenous (IV) infusion
16033829|NCT02639182|Drug|Axitinib|Oral
16033830|NCT02639169|Other|Music Therapy|apply live music through the techniques of music therapy
16033831|NCT02639156|Dietary Supplement|AYMES LONDON|AYMES LONDON is a powder, designed to be mixed with 75ml whole milk to make a dessert style ONS. When made-up, AYMES LONDON provides 303kcal (2.2kcal/ml) and 11.2g protein. It is not designed to be used as a sole source of nutrition. It is a Food for Special Medical Purposes (FSMP) and must therefore be used under medical supervision.
16033832|NCT02639143|Drug|ticagrelor|
16033833|NCT02639143|Drug|Clopidogrel|
16033834|NCT02639130|Drug|Exendin [9-39]|Exendin [9-39] at 350 and 500 pmol/kg/min for infusion as challenge agent
16033835|NCT02639130|Drug|Placebo|Placebo infusion as challenge agent
16033836|NCT02639117|Drug|Vismodegib|Vismodegib 150 mgs po qd for 3 months
16033837|NCT02639104|Radiation|Radiography|"Obtaining patients lateral spot cervical spine radiography and will measure;
~The segmental angle will be measured from C2-C7 inferior endplates on the lateral radiography
~If there is a segmental kyphosis (for example kyphotic angle in C4-5 level), the segmental cobb angle will be measured in the level of the main kyphosis
~The segmental cobb angle will be measured between C2-C4 inferior endplates and C4-C7 inferior endplates"
16033838|NCT02639104|Other|Electromyography|"Serratus anterior needle electromyography:
~The needle can be inserted into the muscle superficially to the fourth to sixth rib in the medial or posterior axillary line. The usual nerve latency time is between 2.6-4 ms."
16033839|NCT02639091|Drug|BAY 94-9343|"In Part 1 of the study, anetumab ravtansine (BAY 94-9343) will be administered by 1-hour IV infusion with a starting dose of 5.5mg/kg(BW) on Day 1 of every treatment cycle (Q3W).
~In Part 2 of the study, anetumab ravtansine (BAY 94-9343) will be administered on Day 2 of Cycle 1 and then on Day 1 of Cycle 2 and all subsequent cycles (Q3W)"
16033840|NCT02639091|Drug|Pemetrexed|Administered at the dose of 500 mg/m2 body surface area (BSA) by 10-minute IV infusion on Day 1 of every treatment cycle (Q3W) in both parts of the study
16033841|NCT02639091|Drug|Cisplatin|Administered at the dose of 75 mg/m2 (BSA) by 2-hour IV infusion on Day 1 of every treatment cycle (Q3W) in both parts of the study
16033842|NCT02639078|Drug|TD-0714|One time dosing in capsule formulation
16033845|NCT02639052|Drug|Botox|10 units of Botox will be intradermally injected into one 4x4cm area on the volar forearm on 1st study visit.
16033846|NCT02639052|Drug|Saline|10 units of the Saline vehicle will be intradermally injected into one 4x4cm area on the contralateral volar forearm on the 1st study visit.
16033847|NCT02639039|Drug|Cortisone Injection|Exact location and technique of injection within the region of the involved greater trochanter will be determined by the provider. The number of f/u visits within 6 wks following initiation of treatment will be determined by the provider, but CI is the only treatment.
16033848|NCT02639039|Procedure|Trigger Point Dry Needling|Exact location of needle insertion, technique and number of penetrations within the region of the involved posterolateral hip will be determined by the provider. The number of f/u visits within 6 wks following initiation of treatment will be determined by the provider, but TDN is the only treatment.
16033849|NCT02639026|Radiation|Radiotherapy|two schedules of radiotherapy (8 Gy x 3 fractions and 17 Gy x 1 fraction)
16033850|NCT02639026|Drug|MEDI4736|20 mg/kg MEDI4736 every 4 weeks for 4 doses, followed by 10 mg/kg MEDI4736 monotherapy every 2 weeks for 18 doses
16033851|NCT02639026|Drug|Tremelimumab|1 mg/kg every 4 weeks for 4 doses
16033852|NCT02639013|Procedure|transducer technique|the nurses will receive the intervention ( the transducer method) to measure intraabdominal pressure intraabdominal hypertension and how to measure intraabdominal pressure in the third section
16033853|NCT02639000|Procedure|Embryo transfer|Embryo transfer of maximum of 2 embryos at cleavage or blastocyst stage
16033854|NCT02638987|Device|Dry needling|Dry needling (DN) is a myofascial treatment technique, in which a thin, solid filiform needle is inserted directly into the MTrP. During dry needling, local twitch responses (LTR) can be elicited. These are involuntary contractions of muscle fibers, leading to muscle relaxation, an increase in blood flow,recovery of the muscle metabolism and thus a reduction of pain and stiffness.
16033855|NCT02638974|Other|Medical Skin Camouflage|Medical skin camouflage is a prescription preparation designed to cover scars and other skin conditions
16033856|NCT02638961|Other|IMT|Patients allocated to IMT arm will receive standard medical treatment and will be instructed to train at home twice daily, for 20 minutes each session, and during 12 weeks using a threshold inspiratory muscle trainer (Threshold IMT®, Respironics Inc.). All of them will be instructed by a respiratory therapist and educated to maintain a diaphragmatic breathing during the training period. The subjects start breathing at a resistance equal to 25-30% of their maximal inspiratory pressure (MIP) for 1 week. The respiratory therapist examines the patients at weekly intervals by checking the diary card and measuring their MIP each time. The resistance is modified each session according to their 25-30% of their MIP measured.
16033857|NCT02638961|Other|FES|Patients allocated to FES arm will receive standard medical treatment and will be trained in a FES program of both legs by a physiotherapist for 45 minutes a day, 2 days per week for a total of 12 weeks. Eight adhesive electrodes are positioned on the skin over the quadriceps and gastrocnemius muscles of both legs. The stimulator is configured to deliver a direct electrical current at 25 Hz for 5 seconds followed by a 5-second rest. The intensity of the stimulation is adjusted to achieve a visible muscle contraction without discomfort.
16033858|NCT02638961|Other|Standard treatment|Patients allocated to this arm will not receive any physical therapy, only standard medical treatment. They will be checked weekly by a physiotherapist who measures their maximal inspiratory mouth pressure each time.
16033859|NCT02638948|Drug|BMS-986142|BMS986142 specific dose on specific days
16033860|NCT02638948|Drug|Placebo|Placebo of BMS-986142 specific dose on specific days
16033861|NCT02638948|Drug|Methotrexate|Methotrexate specific dose on specific days
16033862|NCT02638935|Device|Ultrasound- Virtual Touch Tissue Imaging Quantification|Siemens Medical Solutions USA, Inc. (Mountain View, CA) has implemented Virtual Touch Tissue Imaging Quantification (VTIQ) technology on a commercially available general purpose US imaging system (trade name: Acuson S2000 or S3000). This system has received clearance under Food and Drug Administration (FDA) 510(k) number K072786 (S3000) and K130881 (VTIQ). The technology uses a set of tailored US pulses (Acoustic Radiation Force Impulse, ARFI) to induce shear waves in breast tissue due to tissue displacement. A set of standard B-mode pulses detect the perpendicular shear waves. The displacement signals can be processed using algorithms on a Virtual Touch IQ-equipped system in order to calculate the shear wave velocity.
16033863|NCT02638922|Drug|Estradiol|Estradiol containing compounds administered orally in a non-randomized manner.
16033864|NCT02638909|Drug|ceritinib|Treatment with ceritinib will continue until patient experiences unacceptable toxicity that precludes further treatment, discontinues treatment at the discretion of the investigator or patient, starts a new anticancer therapy and/or dies.
16033865|NCT02638896|Drug|etanercept (Half-Dose)|AS patients who satisfied the criteria for disease remission (ASDAS<1.3) will be randomized to one of the three treatment arms. In the dose reduction arm, patients will receive etanercept 50 mg subcutaneous injections every other weeks .
16033866|NCT02638896|Drug|etanercept (Full-Dose)|AS patients who satisfied the criteria for disease remission (ASDAS<1.3) will be randomized to one of the three treatment arms. In the dose maintenance arm, patients will receive etanercept 50 mg subcutaneous injections every weeks.
16033867|NCT02638896|Drug|Sulfasalazine|AS patients who satisfied the criteria for disease remission (ASDAS<1.3) will take sulfasalazine (2g/d) from week12 to week48.
16033868|NCT02638896|Drug|Celecoxib|Celecoxib (0.4g/d) will be the background therapy.
16033869|NCT02638870|Drug|Amitriptyline|This was a prospective, observational study conducted at Samsung Medical Center, Seoul, Korea. Enrolled IBS patients underwent colonoscopy and colonoscopy-related pain score was evaluated. After colonoscopy, all patients received 5 mg amitriptyline once daily at bedtime for the first week and 10 mg for the subsequent 3 weeks. After the intervention period of 4 weeks, the treatment response was determined.
16033870|NCT02638857|Procedure|TACE|lipiodol 10-20ml,MMC 8～10mg,EADM20～40mg. According to tumor area of maximum diameter,0.1～0.2ml/cm2 hepatic arterial infusion.Each cycle received one TACE treatment on day 13,34,55.
16033871|NCT02638857|Biological|Dendritic Cell|DC suspension (1×107 DC+ physiological saline + 0.25% human serum albumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62.
16033872|NCT02638857|Drug|lipiodol|lipiodol 10-20ml,hepatic arterial infusion
16033873|NCT02638857|Drug|Mitomycin (MMC)|MMC 8～10mg. According to tumor area of maximum diameter,0.1～0.2ml/cm※2, hepatic arterial infusion.
16033874|NCT02638857|Drug|Epirubicin(EADM)|EADM20～40mg. According to tumor area of maximum diameter,0.1～0.2ml/cm※2 hepatic arterial infusion.
16033875|NCT02638857|Biological|Precision Multiple Antigen T Cell|PMAT cell suspension (1-6×109 PMAT + physiological saline + 0.25% human serum albumin) 300ml for each infusion, IV (in the vein) for each infusion 3 cycles, each cycle received one infusions on day 21, 42, 63.
16033876|NCT02638831|Drug|Ketorolac Tromethamine|Ketorolac tromethamine gel 2% for external application. Column of gel about 3-5 cm is applied on the area of maximum pain three times a day for 10 days
16033877|NCT02638831|Drug|Ketoprofen|Ketoprofen gel 2.5% for external application Column of gel (3-5 cm) is applied with a thin layer on the skin in the area of maximum pain 3 times a day for 10 days
16033878|NCT02638818|Procedure|minimally invasive pancreaticoduodenectomy|Surgical technique (minimally invasive versus open) will be at the discretion of the operating surgeon. Patients will not be randomized to a treatment arm.
16033879|NCT02638818|Procedure|traditional pancreaticoduodenectomy|Surgical technique (minimally invasive versus open) will be at the discretion of the operating surgeon. Patients will not be randomized to a treatment arm.
16033880|NCT02638805|Drug|ITCA 650 Osmotic Mini Pump 20/60 mcg/day|ITCA 650 osmotic mini pump delivering exenatide 20/60 mcg/day
16033881|NCT02638805|Drug|ITCA 650 Osmotic Mini Pump 60 mcg/day|ITCA 650 osmotic mini pump delivering exenatide 60 mcg/day
16033882|NCT02638805|Drug|Metformin|Stable dose for at least 3 months (at least 1000 mg/day)
16033883|NCT02638805|Drug|Liraglutide|Stable dose for at least 3 months (at least 1.2 mg/day)
16033884|NCT02638792|Behavioral|Internet-based exposure therapy (I-ET)|"The internet-based exposure therapy (I-ET) group receives a ten-week Internet-based CBT treatment, which is an extended version of the self-help book Sluta älta och grubbla med kognitiv beteendeterapi (How to quit worrying and ruminating with Cognitive behavior therapy) by licensed psychologist Olle Wadström (2007). The main focus of the book is to expose to the frightening word/image and refrain from using neutralizing thoughts. This is supposed to lead to the extinction of upsetting words/images."
16033885|NCT02638792|Behavioral|Internet-based stress management therapy|The I-SMT group receives a ten-week Internet-based CBT treatment focused on stress and how to manage stressful situations. This protocol is based on current evidence based recommendations for worry and has shown to be effective when delivered via the internet for irritable bowel syndrome and hypochondric worries.
16033886|NCT02638779|Biological|Blood sampling|Specific Blood sampling will be performed in patients and healthy volunteers
16033887|NCT02638766|Drug|regorafenib|Treatment with regorafenib 160mg once a day, 3 weeks on / 1 week off in cycles of 28 days
16033888|NCT02638753|Other|education|Patients will be educated about pain neurophysiology.
16033889|NCT02638753|Other|education combined with hypnosis|Patients will be educated about pain neurophysiology combined with hypnosis.
16033890|NCT02638740|Procedure|SCALING AND ROOT PLANING (SRP)|Scaling and root planning done with ultrasonic scalar with reinforcement of oral hygiene measures and follow up for 90 days.
16033891|NCT02638740|Procedure|MUSTARD OIL AND SALT MASSAGE WITH SRP|Scaling and root planing was done with ultrasonic scalar. It was followed by gum massaging with 0.32gm salt in 5ml mustard oil for 5min, twice daily for 90 days.
16033892|NCT02638727|Drug|L-Citrulline|This group treat with L-Citrulline (3 grams per day)
16033893|NCT02638727|Drug|placebo|This group treat with placebo dayley
16033894|NCT02638714|Biological|Stem Cells|Intervention: Transplantation of autologous purified stem cells
16033895|NCT02638701|Drug|Infliximab|Please see protocol for details.
16033896|NCT02638688|Other|ultrasound|
16033897|NCT02638675|Behavioral|Wellness program|All participants have access to Change4Life, a web-based health education and behaviour change program. Individuals are rewarded with very modest incentives (uncertain chance; less than 1 in 100 chance of earning) when they complete learning modules or health tasks.
16033898|NCT02638675|Device|Accelerometer|All participants will be asked to wear the StepsCount Piezo accelerometer, which tracks steps and bout minutes of MVPA per day, synchronize the device to the Change4Life program, and reach daily step count goals for 24 weeks.
16033899|NCT02638675|Behavioral|Incentive|During the first 12 weeks, participants will be eligible to earn $1 in vouchers (e.g., grocery, cinema) when daily goals are reached. The total amount available over the 3-month intervention period will be $90 (9,000 points). During weeks 13 to 24, participants will not receive daily reward points for completing step count goals.
16033900|NCT02638662|Other|Observational|Questionnaires are completed such as self-evaluation questionnaire (STAI), Beck Depression Inventory, FertiQol International and Daily stress questionnaire
16033901|NCT02638649|Procedure|Lung ultrasound|At each call, the paramedic will initially evaluate the patient clinically conducting a standard history and physical exam. The paramedic will then use the portable U/S machine to look for the presence of either unilateral or bilateral B-lines indicating possible pneumonia (in the case of unilateral B-lines) or pulmonary edema (in the case of bilateral B-lines). The paramedic will then document the presence or absence of B-lines for each lung on the prehospital study sheet. The paramedic will then use the U/S to evaluate for the presence of pleural effusions, lung sliding and pericardial effusion.
16033902|NCT02638649|Device|ultrasound|
16033903|NCT02638636|Behavioral|Internet-based exposure therapy|The treatment is a 10 week long cognitive behavior therapy. It is based mainly on the principles of exposure; i.e. the participant is instructed to approach situations they have avoided in order to reduce or avoid pain or other aversive experiences until they feel less discomfort and extended behavior repertoire in presence of pain and aversive inner experiences Other interventions include psychoeducation, mindfulness and acceptance strategies and are employed in order to facilitate exposure.
16033904|NCT02638623|Drug|Lactated Ringer|2L Lactated Ringer administered prior to primary knee or hip arthroplasty
16033905|NCT02638623|Drug|Placebo|No additional fluids will be administered
16033950|NCT02638376|Radiation|0.1% Riboflavin ophthalmic solution (KXL System With vibeX Rapid)|"KC Eyes will be irradiated at 30mW/cm2 for 4 minutes continuous or 8 minutes pulse treatment: 1 second on 1 second off.
~PLEc Eyes will be irradiated at 30mW/cm2 for 4 minutes continuous or 8 minutes pulse treatment: 1 second on 1 second off."
16033989|NCT02638025|Device|OCT|Anterior Segment Spectral-domain Optical Coherence Tomography
16034076|NCT02637427|Biological|Fresh frozen plasma transfusion|Pre-procedure fresh frozen plasma transfusion (15 cc per Kg to a maximum of 5 units)
16033906|NCT02638610|Device|Cochet-Bonnet aesthesiometer|"The eyelid's sensation will be assessed at 6 points of the eyelid using the Cochet-Bonnet aesthesiometer (Luneau Ophtalmologie, Paris, France). Measurements will take place before surgery, and two weeks, three months and six months after surgery.
~This instrument contains a 6 centimeters long, retractable, flexible monofilament. For any given length, when applied perpendicularly to a test surface, the filament will exert a precise pressure before visibly bending. The filament's length inversely corresponds to the pressure exerted by the aesthesiometer such that the shorter the filament length, the more pressure it exerts on the test surface."
16033907|NCT02638597|Drug|Gemfibrozil|FDA Approved Drug(s)/Biologic(s) (study use is not an FDA-approved use)
16033908|NCT02638597|Behavioral|smoking cessation counseling|smoking cessation counseling
16033909|NCT02638584|Drug|Ilaprazole|Ilaprazole 10mg 2tablets once a day(1 times / day), before breakfast
16033910|NCT02638584|Drug|Rabeprazole|Rabeprazole 20mg 1tablets once a day(1 times / day), before breakfast
16033911|NCT02638571|Other|enhanced education on pulse use in complementary foods|Enhanced Nutrition education with sessions and counseling by health extension workers
16033912|NCT02638558|Other|written + oral explanation|
16033913|NCT02638558|Other|written explanation|
16033914|NCT02638545|Drug|Dexmedetomidine|Sedation with propofol and remifentanyl will be replaced by a sedation with dexmedetomidine and remifentanyl
16033915|NCT02638532|Procedure|Foot Fat Pad Grafting|Fat tissue to be used for grafting is harvested (usually from abdomen or thighs) with a small liposuction cannula. The fat tissue is then sterilely centrifuged and allowed to decant before separating the fluid and oil layers from the fat tissue fraction. The aspirated fat is then loaded into 1cc syringes and injected into the plantar fat pad using specialized injection cannulas.
16033916|NCT02638519|Other|Traditional Proton fMRI|Conventional proton fMRI will be performed. During the functional imaging acquisitions, the participant will be asked by the research team to perform simple tasks. These tasks will be completed while the participant breathes air (normal breathing).
16033917|NCT02638519|Other|Hyperpolarized Xenon-129 fMRI|HP 129Xe fMRI data will be acquired from all participants. Hyperpolarized xenon (NeuroXene) is expected to produce images that provide more clinically relevant information than traditional proton scans. Simple tasks will be performed by participants while breathing NeuroXene according to several inhalation procedures.
16033918|NCT02638519|Drug|Hyperpolarized Xenon-129|Participants will be asked to inhale specified amounts of NeuroXene according to several inhalation procedures. NeuroXene is the trade name for hyperpolarization of xenon-129 balanced with oxygen and nitrogen using a Xemed LLC polarizer. Hyperpolarization does not change the chemical or physical properties of xenon gas.
16033919|NCT02638519|Device|1H-129Xe Dual-Tuned Quadrature Head Coil|A 1H-129Xe dual-tuned quadrature head coil (Clinical MR Solutions, LLC) will be used in this study. The RF coil will be used to acquire MRI images of the human brain after inhalation of hyperpolarized xenon-129 gas, and permits the acquisition of both conventional proton and HP xenon gas images.
16033920|NCT02638506|Drug|Fentanyl|All patients will receive a 1.5 mcg⁄kg dose of fentanyl. This will be administered intranasally via a mucosal atomiser device (MAD) using 50 mcg/mL solution with a 2 mL syringe
16033921|NCT02638506|Other|Salinex|All patients will receive an equivalent volume of similar looking placebo to fentanyl (1.5 mcg/kg dose). This will be administered intranasally via a mucosal atomiser device (MAD) using 50 mcg/mL solution with a 2 mL syringe
16033922|NCT02638480|Device|KneeMD|KneeMD is a subject-controlled knee rehabilita¬tion device that helps subjects who have undergone total knee replacements or other major knee surger¬ies improve range of motion and stretch in extension.
16033923|NCT02638467|Drug|Bosutinib|Subjects will receive 400mg of bosutinib once daily from day +30 after transplant, by mouth with food, preferably in the morning. Bosutinib will also be administered from day at least -45 to day -15 to assess the sensitivity of patient CML to this TKI.
16033924|NCT02638467|Procedure|Bone Marrow Transplant|"Samples of the unrelated stem cell graft shall be characterised with respect to the number of CD34 positive cells per kg body weight of the recipient.
~The number of transplanted CD34 positive cells per kg body weight (BW) of the recipient shall be recorded in the Case Report Form (CRF). If the transplant was cryopreserved the number of viable CD34 positive cells has to be determined after thawing and documented.
~The goal is to transplant > 3 x 106 CD34+ cells/kg BW recipient from bone marrow or > 3 x 108 nucleated cells/kg BW recipient from bone marrow"
16033925|NCT02638467|Drug|Bone Marrow cells|
16033926|NCT02638454|Procedure|Acute Resistance Exercise|1 bout of high-intensity resistance exercise at 80% of the individuals 1 repetition maximum
16033927|NCT02638441|Other|hospital anxiety and depression scale|Detection of infertility effect on emotional status
16033928|NCT02638428|Procedure|CancerSCAN™|Targeted deep sequencing
16033929|NCT02638428|Drug|Ifosfamide|
16033930|NCT02638428|Drug|Carboplatin|
16033931|NCT02638428|Drug|Etoposide|
16033932|NCT02638428|Drug|Fludarabine|
16033933|NCT02638428|Drug|Cytarabine|
16033934|NCT02638428|Drug|Pazopanib|
16033935|NCT02638428|Drug|Sorafenib|
16033936|NCT02638428|Drug|Axitinib|
16033937|NCT02638428|Drug|Crizotinib|
16033938|NCT02638428|Drug|Dasatinib|
16033939|NCT02638428|Drug|Erlotinib|
16033940|NCT02638428|Drug|Everolimus|
16033941|NCT02638428|Drug|Imatinib|
16033942|NCT02638428|Drug|Ruxolitinib|
16033943|NCT02638428|Drug|Vandetanib|
16033944|NCT02638428|Drug|Vemurafenib|
16033945|NCT02638428|Drug|Trastuzumab|
16033946|NCT02638415|Procedure|HVPG-guided therapy|"Patients with an HVPG over 20mmHg will be suggested to receive transjugular intrahepatic portocaval shunt (TIPS) or surgical shunt operation.
~Patients with an HVPG between 16 and 20mmHg can choose either endoscopic treatment or TIPS according their willingness and indication.
~Patients with an HVPG below 16mmHg will be treated by endoscopy plus Carvedilol, until endoscopic treatment fails."
16033947|NCT02638415|Other|routine therapy|Patients start treatment without HVPG measurement and receive endoscopic therapy plus Carvedilol.
16033948|NCT02638415|Drug|Carvedilol|Patients in HVPG group with HVPG below 16mmHg and all patients in non-HVPG group will take Carvedilol 12.5mg/d if they have no contraindications.
16033949|NCT02638389|Drug|Sirolimus|evaluate the efficacy and safety of sirolimus in these patients
16033988|NCT02638038|Drug|INT131|INT- 131
16033951|NCT02638376|Procedure|simultaneous KXL and topography-guided transepithelial photorefractive keratectomy(PRK)|"The (Partial, Spherically Corrected) Topography-guided Transepithelial PRK Technique. Is performed with WaveLight® EX 500 excimer laser (Alcon Laboratories Inc, Ft Worth, Texas) customized platform.
~This software utilizes topographic data from the linked topography device (Topolyzer; Wave- Light GmbH, Erlangen, Germany). The image of the planned surgery is generated by the laser software.
~The topography-guided PRK is used to normalize the cornea by reducing irregular astigmatism while treating part of the refractive error. The maximum ablation depth of stromal ablation is set at 50um.
~A 6.5-mm, 50-μm phototherapeutic keratectomy (PTK) was performed to remove the corneal epithelium. Partial topography- guided PRK laser treatment was applied. A cellulose sponge soaked in mitomycin C (MMC) 0.02% solution was applied over the ablated tissue for 20 seconds followed by irrigation with 10 mL of chilled balanced salt solution."
16033952|NCT02638363|Behavioral|Cognitive behavioral therapy|The participants will receive 12-16 sessions of manualized group-based CBT with a maximum of 8 participants in each group. The therapists are trained psychiatrists, psychologists, or nurses under supervision. The treatment manuals are developed by mental health professionals in the Capital Region of Denmark. The treatment program includes traditional CBT components (e.g., psychoeducation, identification of thoughts and feelings, exposure, cognitive restructuring, and relapse prevention).
16033953|NCT02638350|Device|Strategy with lung ultrasound|"Each patient admitted for suspicion of acute lung edema will be treated according to the protocol of the emergency department.
~Another doctor will independently do a lung ultrasound and measurement of the inferior vena cava. The ultrasound results are not made available to the doctor in charge of the patient.
~At the end of the study, all the files will be analyzed by a independent committee, blinded ultrasound results for the final diagnosis of acute pulmonary edema."
16033954|NCT02638337|Drug|Ospemifene|60 mg tablet
16033955|NCT02638337|Drug|Placebo|Tablet identical to the ospemifene tablet without drug
16033956|NCT02638324|Procedure|Renal nervous denervation|The heart failure patients will undergo renal nervous denervation if they have not properly responded to medication and biventricular pacing therapy.
16033957|NCT02638298|Device|Prevana Dressing|negative pressure wound therapy (NPWT) dressing
16033958|NCT02638298|Other|Standard Dry Gauze Dressing|Standard Dry Gauze Dressing
16033959|NCT02638285|Drug|LH|
16033960|NCT02638285|Drug|HCG|
16033961|NCT02638285|Drug|Clomiphene|
16033962|NCT02638272|Procedure|no debridement|It is a spinal surgery performed with isolated posterior instrumentation without debridement.
16033963|NCT02638259|Drug|GP2015|Enbrel comparator
16033964|NCT02638246|Behavioral|Internet-delivered, Incentive-based intervention + Motivational Interviewing|Blood glucose monitoring was verified by videos uploaded to a secure server. Participants in the experimental group received incentives for adherence whereas participants in the control group received adherence independent of adherence.
16033965|NCT02638246|Behavioral|Internet-delivered, non-contingent incentives + Motivational Interviewing|
16033966|NCT02638233|Drug|Sofosbuvir 400mg / Ledipasvir 90 mg (FDC)|
16033967|NCT02638207|Drug|NewGam|In the Dose-evaluation Phase, all patients will receive a loading dose of 2.0 g/kg Newgam (administered over two consecutive days), followed by seven infusions of the maintenance dose the patient has been randomized to (0.5, 1.0 or 2.0 g/kg NewGam), also administered over two consecutive days every 3 weeks (±4 days). If a patient is randomized to receive the low or medium NewGam dose, the same volume with the same infusion rate as would have been applied in case the patient would have been randomized to 2.0 g/kg NewGam will be used, thus supplemented with an authorized 0.9% w/v isotonic sodium chloride solution as appropriate and detailed in the following infusion bag split to maintain the blinding
16033968|NCT02638194|Other|Active smoking of Tobacco Hookah for 2 hours|
16033969|NCT02638194|Other|Exposure to tobacco hookah second hand smoke|
16033970|NCT02638194|Other|Visit a win bar|Participants will visit a wine bar for food and/or drinks
16033971|NCT02638181|Procedure|trabeculectomy|
16033972|NCT02638168|Drug|Immediate Release Methylphenidate|The medication assessment procedure will be a double-blind, within-subject evaluation of placebo and matching evening dose of IR MPH rounded to the nearest 2.5mg increment with a max IR MPH dose of 0.3mg/kg. Expected evening dose range will be from 2.5mg to 20mg with most participants receiving between 5 to 15mg per evening dose. Dose will be determined based on current dose of their morning extended release stimulant
16033973|NCT02638168|Drug|Placebo|inert placebo ingredient
16033974|NCT02638142|Drug|Continuous Furosemide Infusion|Intravenous continuous Furosemide infusion
16033975|NCT02638142|Drug|Intermittent Furosemide Infusion|Intravenous bolus intermittent Furosemide Infusion
16033976|NCT02638129|Drug|Naltrexone HCl/Bupropion HCl ER|Naltrexone HCl 8 mg/bupropion HCl 90 mg ER combination tablets
16033977|NCT02638129|Drug|Placebo|Naltrexone HCl/bupropion HCl placebo-matching tablets
16033978|NCT02638116|Drug|Ibrutinib|Ibrutinib will be administered at a dose of 560 milligram (mg) orally (4 x 140 mg capsules) on Day 1 and Day 7.
16033979|NCT02638116|Drug|Omeprazole|Omeprazole will be administered at dose of 40 mg tablets orally once daily from Day 3 to Day 7.
16033980|NCT02638103|Drug|Fremanezumab|Fremanezumab will be administered as per the dose and schedule specified in the respective arms.
16033981|NCT02638103|Drug|Placebo|Placebo matching to fremanezumab will be administered as per schedule specified in the respective arms.
16033982|NCT02638090|Drug|Vorinostat|Administered per treatment arm guidelines.
16033983|NCT02638090|Drug|Pembrolizumab|Administered per treatment arm guidelines.
16033984|NCT02638064|Procedure|Surgiflo injection|Curettage of sinus cavity then injection of surgiflo material
16033985|NCT02638051|Device|Modulated Electro-Hyperthermia (mEHT)|MEHT is a descendant of hyperthermia initially based on nano-thermal but not temperature-dependent effects of electromagnetic fields and special fractal modulation, whose effect could 3-4 times exceed the effect of the overall heating (macroscopic temperature elevation). MEHT does not require hyperthermia-range temperatures and could be performed safely without invasive thermal control. EHY-2000 local machine is used for mEHT in the trial.
16033986|NCT02638051|Dietary Supplement|TCM Herbal Decoction (Shi Pi)|Shi Pi Decoction can warm Yang, invigorate the spleen, promote Qi circulation to induce diuresis and treat Foot-Taiyin meridian in Gu Zhang.
16033987|NCT02638051|Drug|IPCI (CDDP+5FU)|Intraperitoneal chemoinfusion of CDDP (30-60 mg) and 5-fluorouracil (500-600 mg/sqm).
16033990|NCT02638012|Drug|Floseal|Topical lidocaine spray (2%) is then administered using 1-2 sprays in the affected nasal cavity via the nostril that is to have Floseal® applied. Once the bleeding has stopped following application of the Floseal® a 50 cc syringe with sterile saline will be used to irrigate the treated nasal cavity to remove any excess Floseal® product as per manufacturer recommendations. This is done with the patient's head tilted downwards at a 30 degree angle so that the irrigation and excess product is removed from the nasal cavity. Once the irrigation is complete, the nasal cavity is inspected for evidence of continued bleeding.
16033991|NCT02638012|Other|Packing|If bleeding is not controlled after up to two Floseal applications, the gel and clots will be removed with suction, and the patient will be treated with a standard packing treatment (standard of care).
16033992|NCT02637999|Drug|PEG IFN alfa-2a|
16033993|NCT02637999|Drug|Myrcludex B|
16033994|NCT02637986|Dietary Supplement|Urex Plus - containing L. rhamnosus GR-1 and L. reuteri RC-14|2 capsules will be given per day
16033995|NCT02637986|Other|Placebo - capsule with no active ingredient|2 capsules will be given per day
16033996|NCT02637973|Drug|Empagliflozin|25 mg once daily
16033997|NCT02637973|Drug|Placebo|once daily
16033998|NCT02637960|Drug|Fedovapagon 2 mg|One daily dose of 2 mg fedovapagon for 12 weeks
16033999|NCT02637960|Drug|Placebo|One daily dose of placebo (matched to fedovapagon) for 12 weeks
16034000|NCT02637947|Device|catheter ablation using magnetic navigation|elimination of cardiac arrhythmias through heating and destroying heart tissue with faulty electrical pathways through the use of Stereotaxis's Niobe ES System with the NaviStar RMT ThermoCool catheter or other magnetically compatible catheters.
16034001|NCT02637947|Device|catheter ablation using manual navigation|elimination of cardiac arrhythmias through heating and destroying heart tissue with faulty electrical pathways through the use of the NaviStar ThermoCool catheter or other manually navigated catheters.
16034004|NCT02637921|Other|Hypoxia|21 days confinement in normobaric hypoxic (FiO2 = 14%)
16034005|NCT02637921|Other|Ambulatory|Participants hava a standardized activity level throughout the intervention
16034006|NCT02637921|Other|Normoxia|21 days confinement in normobaric normoxic (FiO2 = 21%) environment
16034007|NCT02637921|Other|Bed Rest|Participants remain on supine bed rest throughout the intervention
16034008|NCT02637921|Other|Standardised nutritional intake|Macronutrient, salt and dietary energy intake will be standardized per kg body weight for each participant
16034009|NCT02637908|Behavioral|Mindfulness training|6-weeks of group-based mindfulness training for parents
16034010|NCT02637895|Drug|Placebo|Placebo pill matching Vortioxetine.
16034011|NCT02637895|Drug|Vortioxetine|Immediate Release 10 mg. Vortioxetine Pill
16034012|NCT02637882|Other|Ear plug|The patients will receive the first intervention (ear plug) in the third night (N3) from 9 pm to 6 am.and the patient will complete the sleep questionnaire sheet and delirium scale.
16034013|NCT02637882|Other|Eye mask|The patients will receive the second intervention (eye mask) in the second night (N2) from 9 pm to 6 am.and the patient will complete the sleep questionnaire sheet and delirium scale
16034014|NCT02637882|Other|Mixed intervention (ear plug and eye mask)|The patients will receive the intervention (eye mask and ear plug) in the first night (N1) from 9 pm to 6 am.and the patient will complete the sleep questionnaire sheet and delirium scale
16034015|NCT02637869|Other|Alternative Payment Model|Oregon developed an Alternative Payment Methodology (APM). Under this APM pilot participating CHCs will receive a prospective payment system (PPS) payment as a capitated equivalent in a per-member-per-month rate for all of their Medicaid patients
16034016|NCT02637856|Drug|Ocrelizumab|Participants will receive ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks).
16034017|NCT02637856|Drug|Ocrelizumab|Participants will receive an additional single 600-mg dose IV infusion at a shorter infusion rate (approximately 2 hours instead of 3.5 hours)
16034018|NCT02637843|Device|Slender Sheath|Comparing outcomes for two different sheaths used during radial CAG/PCI
16034019|NCT02637830|Other|Application of fluoride varnish (22600 ppm F, Duraphat) at the begining of the study|
16034020|NCT02637830|Other|Application of fluoride toothpaste (1500 ppm F, Crest) twice a day for 3 days of the study|
16034021|NCT02637830|Other|Application of placebo toothpaste (0 ppm F, Ice Fresh) twice a day for 3 days of the study|
16034022|NCT02637804|Device|stenfilcon A|contact lens
16034023|NCT02637804|Device|narafilcon A|contact lens
16034024|NCT02637804|Device|delefilcon A|contact lens
16034025|NCT02637791|Device|Virtual glove|The intervention (the virtual glove) consists of a hand-mounted power unit, with four infra- red light emitting diodes (LEDs) mounted on the user's finger tips. The LEDs are tracked using one or two Nintendo Wii motes mounted by the computer screen on which the games are displayed to translate the location of the user's hand, fingers and thumb in 3D space. Three games have been produced especially for the project with the help of therapists and stroke patients. In order to play them, users have to perform the movements of reach to grasp, grasp and release, pronation and supination that are necessary to effect many activities of daily living.
16034026|NCT02637778|Dietary Supplement|Cardioprotective diet|The 'cardioprotective diet' is characterized by (i) adequate energy intake, (ii) intake of carbohydrates, protein, fat according to the guidelines of the German Society of Nutrition (DGE e. V.), (iii) desirable intake of saturated fatty acids (SFA, 7 En%), monounsaturated fatty acids (MUFA, > 10 En%), polyunsaturated fatty acids (PUFA, approx. 10 En%) and in particular n-3 LC-PUFA, (iv) encouraged consumption of vegetables, fruits, cereals, (v) salt and sugar reduction, (vi) avoiding of highly processed, calorie-dense, nutrient-poor food as well as (vii) encouraged physical activity.
16034073|NCT02637453|Procedure|CPVI+6L|After PVI, 6 ablation lines were added with an extension from pulmonary vein ostium at 1, 3 and 6 o'clock (from internal view) of left PV and 6, 9 and 11 o'clock of right PV
16034074|NCT02637440|Procedure|FFR guided PCI|Patients undergo Fractional Flow measurement (FFR) followed by PCI, if the FFR is less than 0.8
16034075|NCT02637440|Procedure|Angio guided PCI|Patients receive PCI without FFR measurement
16035417|NCT02627950|Drug|Ticagrelor|180 mg ticagrelor orally
16034027|NCT02637778|Dietary Supplement|Cardioprotective diet + 3 g EPA + DHA/d|The 'cardioprotective diet' is characterized by (i) adequate energy intake, (ii) intake of carbohydrates, protein, fat according to the guidelines of the German Society of Nutrition (DGE e. V.), (iii) desirable intake of saturated fatty acids (SFA, 7 En%), monounsaturated fatty acids (MUFA, > 10 En%), polyunsaturated fatty acids (PUFA, approx. 10 En%) and in particular n-3 LC-PUFA, (iv) encouraged consumption of vegetables, fruits, cereals, (v) salt and sugar reduction, (vi) avoiding of highly processed, calorie-dense, nutrient-poor food as well as (vii) encouraged physical activity.The participants will consume additional n-3 LC-PUFA (3 g EPA+DHA/d)
16034028|NCT02637765|Behavioral|Increased Physical Activity|Patients will receive a program of increased physical activity starting from 5000 steps/day up to 12000 steps/day after 8 weeks and an 8-week recreational program of brisk walking/running (3 times a week).
16034029|NCT02637752|Behavioral|Lifestyle counseling or nutrition/physical counselling|A brief (5-10 minute) counseling session for caregivers of the intervention group aimed to encourage an increase in the child's physical activity and decrease sugar-sweetened beverage consumption and screen time. Additionally, the caregivers of the intervention group were provided with the following handouts: five steps to a healthy body weight for teens; beverages; physical activity tips for children 5-11 years; Canadian physical activity guidelines for children 5-11; and Canadian sedentary behavior guidelines for children 5-11.
16034030|NCT02637739|Device|hysteroscope|Women of PUL with β-hCG > 1000 IU/L or abnormal β-hCG trend (increase < 66% or decrease < 15%) were offered HSC.
16034031|NCT02637726|Drug|Propofol : TCI Schnider|Target controlled infusion using schnider model for propofol
16034032|NCT02637726|Drug|Propofol : TCI Kataria|Target controlled infusion using Kataria model for propofol
16034033|NCT02637726|Drug|Propofol : TIVA|Total intravenous anesthesia without use of a pharmokinetic model
16034034|NCT02637726|Device|EEG Monitoring|Maintaining a bispectral index between 45 and 55
16034035|NCT02637726|Drug|Remifentanil|Remifentanil at discretion of the anesthesiologist
16034036|NCT02637713|Device|Stretta|Stretta is an FDA approved device that delivers Radiofrequency energy delivery to the lower esophageal sphincter. It is approved for the management of GRED.
16034037|NCT02637713|Procedure|Radiofrequency (RF) Energy to the LES (Stretta Procedure)|The Stretta procedure is performed endoscopically under moderate sedation or general anesthesia which uses radiofrequency (RF) energy applied to the lower esophagus over 14 minutes per FDA approved procedures.
16034038|NCT02637700|Drug|Intravenous Immunoglobulin|Comparison between intravenous immunoglobulin and placebo (saline 0.9%).
16034039|NCT02637700|Drug|Placebo|Comparison between placebo (saline 0.9%) and intravenous immunoglobulin.
16034040|NCT02637687|Drug|Larotrectinib (Vitrakvi, BAY2757556)|BAY2757556 will be administered orally as capsule or in liquid form over continuous 28-day cycles.
16034041|NCT02637674|Procedure|Uterus Transplant|
16034042|NCT02637661|Other|earlobe crease positive|
16034043|NCT02637661|Other|earlobe crease negative|
16034044|NCT02637648|Drug|Sodium Oxybate|parallel Group administration
16034045|NCT02637648|Drug|Placebo|parallel Group administration
16034046|NCT02637635|Procedure|Autologous fat transplantation|100 ml of autologous fat will be injected to the reconstruction area 3 month prior the breast reconstruction with expander prosthesis.
16034047|NCT02637635|Procedure|Expander prosthesis|breast reconstruction with expander prosthesis.
16034048|NCT02637622|Other|Best-Worst Scaling (Case 2)|Respondents receive questions asking them to choose the best and worst features of a hypothetical medication.
16034049|NCT02637622|Other|Discrete Choice Experiment|Respondents receive questions asking them to choose the medication they prefer between a pair of hypothetical medications.
16034050|NCT02637609|Other|Likert Scale|Respondents receive questions asking them to rate each barrier or facilitator for diabetes self-management.
16034051|NCT02637609|Other|Best-Worst Scaling (Case 1)|Respondents receive questions asking them to choose the best and worst factors that affect their diabetes self-management among a list of barriers and facilitators.
16034052|NCT02637596|Procedure|Radiofrequency ablation|After laparotomy, intraoperative IOUS quided RFA of primary tumor was performed.
16034053|NCT02637583|Drug|PCV13|Intramuscular injection of 13-valent pneumococcal conjugate vaccine once
16034054|NCT02637583|Drug|PPV23|Intramuscular injection of 23-valent pneumococcal polysaccharide vaccine once
16034055|NCT02637570|Dietary Supplement|Hibiscus tea|
16034056|NCT02637570|Dietary Supplement|green tea|
16034057|NCT02637570|Dietary Supplement|placebo (dextrose)|
16034058|NCT02637557|Drug|IW-3718|
16034059|NCT02637557|Drug|Matching Placebo|
16034060|NCT02637557|Drug|PPI|All participants were taking a standard dose QD PPI (dexlansoprazole, esomeprazole, esomeprazole magnesium, lansoprazole, omeprazole, pantoprazole, pantoprazole sodium sesquihydrate, rabeprazole or rabeprazole sodium) during the study.
16034061|NCT02637544|Other|acupuncture|classical acupuncture therapy
16034062|NCT02637531|Drug|IPI-549 (eganelisib)|IPI-549 daily dose administered orally in 28-day cycles (Part A/BC/D/D-Annex/E)
16034063|NCT02637531|Drug|Nivolumab|Nivolumab (240 mg, Q2W) administered intravenously (IV) in 28-day cycles (Part C/D-Annex/E).
16034064|NCT02637518|Other|Assessment of frailty tools in elderly people|Assessment of the tools as screening/diagnosis instruments in older adults attended in Primary Care. To build the integration of tools in algorithms to be used in each setting of care and along the settings to permit an integrated care in different conditions (isolated assessment or sequential assessment)
16034065|NCT02637505|Procedure|Arthroscopic microfracture (MF)|Arthroscopy With microfracture procedure
16034066|NCT02637505|Procedure|Arthroscopic debridement (AD)|Arthroscopy With debridement procedure
16034067|NCT02637492|Other|Collection of clinical signs and symptoms|Collection of clinical signs and symptoms used for developing a Clinical prediction rule of critical lower limb ischaemia (diagnosed by haemodynamic methods: ankle pressure, toe pressure-laser Doppler or photo-plethysmography, transcutaneous oxygen pressure) in patients with peripheral occlusive arterial disease
16034068|NCT02637479|Device|GammaKnife®|
16034069|NCT02637479|Device|18F-2-fluoro-2-deoxy-D-glucose - positron emission tomography (FDG-PET)|
16034070|NCT02637479|Device|MRI|
16034071|NCT02637466|Drug|Vortioxetine|
16034072|NCT02637453|Procedure|PVI|Pulmonary vein isolation
16034077|NCT02637414|Behavioral|Flourishing App Program|This intervention is based on relaxation, well-being promotion, meditation practices and positive psychology principles. The program is being evaluated in a classroom format into another project and was adapted for this project in the application format for mobile devices. It will last for 8 weeks, with trainings of 15 to 25 minutes, four times a week.
16034078|NCT02637401|Behavioral|Dialectical Behaviour Therapy|
16034079|NCT02637388|Dietary Supplement|Oatwell28 Oatwell Original Powder|
16034080|NCT02637388|Dietary Supplement|Control Breakfast|Isocaloric breakfast without added beta-glucans
16034081|NCT02637375|Drug|Ganetespib|
16034082|NCT02637375|Drug|Paclitaxel|
16034083|NCT02637375|Drug|Doxorubicin|
16034084|NCT02637375|Drug|Cyclophosphamide|
16034085|NCT02637362|Procedure|Ankle block|Ultrasound guided ankle block of the tibial, superficial peroneal and deep peroneal nerves will be performed using a standardised technique
16034086|NCT02637362|Procedure|Sham ankle block|In the supine position with the hip and knee flexed, and the hip externally rotated, the skin from medial malleolus to Achilles tendon will be prepared with chlorhexidine 0.5% solution and allowed to dry. An ultrasound probe (linear array HFL25, Sonosite, Hitchin, UK) will be placed on a line from medial malleolus to achilles tendon to identify the posterior tibial artery and tibial nerve. A Stimuplex A50 needle (B-Braun) will be placed against the skin at the point at which the practitioner would normally have performed insertion of the needle. It will remain there for a total of 30 seconds and then will be removed.
16034087|NCT02637362|Procedure|Metatarsal block|A metatarsal block will be performed using a standardised technique
16034088|NCT02637362|Procedure|Sham metatarsal block|In the supine position, after the surgical incision has been sutured, a 25G standard bevel needle will be placed against the skin at the points at which the practitioner would normally have performed insertions of the needle. It will remain there for a total of 30 seconds and then be removed.
16034089|NCT02637349|Behavioral|POST Intervention|POST Intervention group will receive a tailored survivorship care plan (SCP) at the end of their active treatment. The SCP will be discussed with them. Patient will be asked about satisfaction with the end of treatment session.
16034090|NCT02637349|Behavioral|POST Treatment as Usual|The POST control group may receive a survivorship care plan (SCP) as part of treatment as usual though it is not a usual procedure. They will be asked about their satisfaction with the end of treatment session.
16034091|NCT02637336|Device|Acupuncture|Acupuncture in point 6 of the pericardium channel (neiguan) bilaterally
16034092|NCT02637336|Device|Aerobic exercise|aerobic exercise of moderate intensity
16034093|NCT02637336|Device|Aromatherapy|inhalation of eucalyptus essential oil
16034094|NCT02637323|Drug|FX006 32 mg|Single 5 mL IA injection
16034095|NCT02637323|Drug|TCA IR 40|Single 1 mL IA injection
16034096|NCT02637310|Drug|N02RS1 1200mg|1200mg/day, Three times a day orally, 2 tablets once, 7 days
16034097|NCT02637310|Drug|Placebo|1200mg/day, Three times a day orally, 2 tablets once, 7 days
16034098|NCT02637297|Procedure|Hypnotherapy|Undergo hypnotherapy
16034099|NCT02637297|Other|Questionnaire Administration|Ancillary studies
16034100|NCT02637284|Drug|Bepecin|"Phase 1a: Healthy volunteers will take a single dose of 1, 3 or 6 tablets by mouth of PCO-02 containing 1 mg of Bepecin to study safety and pharmacokinetics.
~Phase 1b: All subjects will take 3 tablets of PCO-02 containing 1 mg of Bepecin every 8 hours during two weeks, to study safety and pharmacokinetics."
16034101|NCT02637284|Drug|Placebo|"Phase 1 a: Healthy volunteers will take a single dose of 1, 3 or 6 tablets by mouth of PCO-03 (placebo) as a control group.
~Phase 1b: All subjects will take 3 tablets of PCO-03 (placebo) every 8 hours during two weeks, as a control group."
16034102|NCT02637271|Other|Low calorie total meal replacement|Participants will be provided instruction in the appropriate use of the meal replacement product. The participants will be directed to refrain from all items of food for a period of 21 days except for the meal replacement products and vitamin supplements provided by the investigators (1120 kcal/day). Optifast™ 800 total meal replacement shakes will be provided to the participants for the 21 day intervention period.
16034103|NCT02637271|Other|Low calorie typical diet|Participants will be directed to use portion control to maintain a calorie level no greater than 1120 kcal per day. The participants will be directed to continue to consume food and beverage items that are representative of their typical diet (with the exception of reduced portions). Participants will be provided resources to assist them in determining caloric content of foods eaten.
16034104|NCT02637258|Other|Ultrasonographic Measurements of Optic Nerve Sheath Diameter|Bedside Ultrasonographic Measurements of Optic Nerve Sheath Diameter
16034105|NCT02637245|Other|No intervention|No intervention
16034106|NCT02637232|Other|Mirvaso® / Onreltea TM|
16034107|NCT02637206|Drug|GSK2894512 Cream|GSK2894512 cream supplied will be white to off-white cream packaged in 28-gram laminate tubes of 2 concentrations: 0.5% and 1%, to be applied topically.
16034108|NCT02637206|Drug|Vehicle Cream|Vehicle Cream (placebo cream without active ingredient) supplied will be white to off-white cream packaged in 28-gram laminate tubes, to be applied topically.
16034109|NCT02637206|Drug|Empty Patch|Empty patches without any ingredients will be used as negative control.
16034110|NCT02637193|Drug|Venlafaxine|Multiple doses of Venlafaxine for 14 days plus 3 days of down titration
16034111|NCT02637193|Drug|Moxifloxacin|400 mg single dose moxifloxacin
16034112|NCT02637193|Drug|Drug - placebo|Placebo administered for 16 days
16034113|NCT02637180|Drug|anti-osteoporotic medication|check previous information
16034114|NCT02637167|Drug|Rifaximin|Rifaximin has negligible intestinal absorption after oral administration, giving it a good safety profile. Unlike systemically available antibiotics, this antimicrobial allows localized enteric targeting of bacteria and is associated with a minimal risk of systemic toxicity or side effects.
16034115|NCT02637167|Drug|Saccharomyces boulardii|The same advantage described above to Rifaximin applies to S. Boulardii, which might be therapeutically sufficient with the advantage of being less disruptive to the instestinal microbiota than broad-spectrum antibiotics.
16034116|NCT02637154|Behavioral|Motivational Interviewing|Motivational Interviewing method
16034117|NCT02637154|Behavioral|Standard Education|Standard Education material will be used
16034118|NCT02637141|Biological|AMG 714|AMG 714 administered by subcutaneous injection
16152408|NCT01762046|Drug|Metformin|
16034119|NCT02637141|Biological|Placebo|Matching placebo to AMG 714 administered by subcutaneous injection
16034120|NCT02637141|Other|Placebo Gluten Challenge|Gluten-free cookies (Finnish rusks)
16034121|NCT02637141|Other|Gluten Challenge|Gluten-containing cookies (Finnish rusks), 1-2 g gluten per serving
16034122|NCT02637128|Drug|artemether-lumefantrine (AL)|Dispersible formulation of artemether-lumefantrine (Coartem-D™; 20mg artemether/120mg lumefantrine per tablet, Novartis, Switzerland) administered twice a day for 3 days according to manufacturer recommended dosing for weight
16034123|NCT02637128|Drug|artesunate-amodiaquine (ASAQ)|Co-formulated artesunate-amodiaquine (25mg artesunate/67.5mg amodiaquine and 50mg artesunate/135mg amodiaquine tablets) administered once a day for 3 days, according to manufacturer recommended dosing for weight
16034124|NCT02637115|Dietary Supplement|Placebo|Consumption of one dose-sachet per day. This dose-sachet contains a placebo (PBS/Glycerol)
16034125|NCT02637115|Dietary Supplement|Live Akk 9|Consumption of one dose-sachet per day. This dose-sachet contains Live Akkermansia muciniphila (one billion per dose-sachet)
16034126|NCT02637115|Dietary Supplement|Live Akk 10|Consumption of one dose-sachet per day. This dose-sachet contains Live Akkermansia muciniphila (ten billion per dose-sachet)
16034127|NCT02637115|Dietary Supplement|Killed Akk|Consumption of one dose-sachet per day. This dose-sachet contains heat-killed Akkermansia muciniphila
16034128|NCT02637102|Other|Not applicable - observational study|
16034129|NCT02637076|Drug|Xyrem|single 3.0 gram dose
16034130|NCT02637063|Behavioral|BlipHub mobile-web app|Mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.
16034131|NCT02637063|Behavioral|BlipHub mobile-web app + health coaching|Telephonic coach-supported mobile web app to promote blood-pressure-reducing diet, physical activity and weight loss.
16034132|NCT02637063|Other|Usual care|No intervention beyond participants' own medical care.
16034133|NCT02637050|Other|Standard of care|At the discretion of the attending physician.
16034134|NCT02637037|Drug|dapagliflozin/metformin XR 5/500 mg test drug (Mount Vernon)|single fixed-combination dose tablets
16034135|NCT02637037|Drug|dapagliflozin/metformin XR 5/500 mg reference drug (Humacao)|single fixed-dose combination tablets
16034136|NCT02637037|Drug|dapagliflozin/metformin XR 10/1000 mg test drug (Mount Vernon)|single fixed-dose combination tablets
16034137|NCT02637037|Drug|dapagliflozin/metformin XR 10/1000 mg reference drug (Humacao)|single fixed-dose combination tablets
16034138|NCT02637024|Radiation|APBI: 30 Gy|30 Gy in 5 fractions of 6 Gy, delivered daily, Monday to Friday, over a period of 5-8 days. A multiple small field 3D-conformal or intensity modulated radiation therapy (IMRT) technique will be used.
16034139|NCT02637024|Radiation|APBI: 27.5 Gy|27.5 Gy in 5 fractions of 5.5 Gy, delivered daily, Monday to Friday, over a period of 5-8 days. A multiple small field 3D-conformal or intensity modulated radiation therapy (IMRT) technique will be used.
16034140|NCT02636972|Drug|OCPs|"Participants in the contraceptive pill groups can use any one of the following contraceptive pills:
~Oestradiol valerate and dienogest, drospirenone and ethinyl estradiol , ethinyloestradiol and levonorgestrel, cyproterone and ethinyl estradiol, ethinylestradiol and norethisterone, Nomegestrol Acetate and Oestradiol and Ethinyl Estra"
16034141|NCT02636959|Other|saline irrigation|HVSI (NeilMed® Sinus Rinse™) versus LVSI (Salinex®) in the early post-operative management in patients with chronic rhinosinusitis. Both are a saline rinse spray.
16034142|NCT02636946|Drug|Bimatoprost SR|Up to three Bimatoprost SR Dose A administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Bimatoprost SR Dose A administrations at Day 4 and Week 16 (Stage 2).
16034143|NCT02636946|Drug|Sham Bimatoprost SR|Up to three Sham Bimatoprost SR administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Sham Bimatoprost SR administrations at Day 4 and Week 16 (Stage 2).
16034144|NCT02636946|Procedure|Selective Laser Trabeculoplasty|Selective Laser Trabeculoplasty administered on Day 1.
16034145|NCT02636946|Procedure|Sham Selective Laser Trabeculoplasty|Sham Selective Laser Trabeculoplasty administered on Day 1.
16034146|NCT02636933|Other|Lung Function Assessment|Lung Function Assessment
16034147|NCT02636920|Other|Therapeutic Education to the Patient (TEP)|"Educational Diagnosis, asking what patient has, what he knows, what he is doing, what he would like to do.
~Therapeutic Contract, to define objectives to reach at the end of educational path, integrating new knowledges and replacing wrong cognitive-behavior models with new schemes.
~Educational Therapeutic Intervention, with individual or group methodologies (Role Playing, Brain Storming) and a disease diary in which patients could describe symptoms, therapies, behaviors and benefits.
~Assessing of the knowledges acquired by patients."
16034148|NCT02636907|Drug|BI 695501 Autoinjector|
16034149|NCT02636907|Drug|BI 695501 Prefilled syringe|
16034150|NCT02636894|Device|Restylane Silk|
16034151|NCT02636881|Procedure|Autologous Chondrocyte Implantation|Implantation of the patients own cartilage cells in a chondral defect of the knee
16034152|NCT02636881|Procedure|Arthroscopic Debridement|Arthroscopic diagnosis and debridement of the lesion, without cartilage therapy. Removal of lose bodies etc.
16034153|NCT02636868|Drug|Lucinactant delivered via investigational delivery device|Lucinactant for inhalation refers to the active investigational agent lucinactant in combination with the investigational delivery device (drug-device combination product)
16034154|NCT02636868|Drug|nCPAP|Nasal CPAP
16034155|NCT02636842|Drug|Aripiprazole Lauroxil|Intramuscular (IM) injection, single dose
16034156|NCT02636829|Other|QALCIMUM questionnaire|All patients will fill out the QALCIMUM questionnaire.
16034157|NCT02636829|Other|Determination of calcium intake by a dietician interview|"All patients will have an interview with a dietician who performs a food survey serving as a reference (gold standard) and based on data from CIQUAL *.
~* CIQUAL Data: Nutritional food composition table available on the website of the ANSES (National Agency for Sanitary Security of Food, Environment and Labour), published by the Observatory of the Nutritional Quality of Foods. This table includes 1500 sheets of 58 nutritional components. The data is integrated into the software (DATAMEAL) for calculating the ingesta parameters at the Nîmes University Hospital."
16034158|NCT02636816|Drug|carbetocin|drug used to increase the tone of uterine muscle to prevent post partum hemorrhage after cesarean delivery.
16034159|NCT02636803|Drug|oxfendazole|group receives a single dose of oxfendazole at 6 or 30 mg/kg or three 6 mg/kg doses
16034160|NCT02636803|Drug|albendazole|group receives one 400 mg dose of albendazole
16034161|NCT02636790|Procedure|Surgery wait time|VCH CRS patients need a waitlist system that promotes wellness and ensures care that focuses on quality - this can be achieved with a prioritized waitlist based on quality of life improvement and decreased healthcare expenditure.
16034162|NCT02636777|Other|no intervention|Patients will be allowed to continue their usual treatment as recommended by their care team.
16034163|NCT02636764|Other|exercise|exercises designed with the objective of strengthening the musculature: flexor and extensor of the knee; extensor, abductor, lateral rotator of the hip.
16034164|NCT02636764|Device|interferential current|The basic principle of Interferential Therapy (IFT) is to utilise the significant physiological effects of low frequency (<250pps) electrical stimulation of nerves without the associated painful and somewhat unpleasant side effects sometimes associated with low frequency stimulation
16034165|NCT02636764|Device|short-wave diathermy|Is a modality that produces deep heating via conversion of electromagnetic energy to thermal energy
16034166|NCT02636764|Device|Low level laser therapy|Laser treatment in which the energy output is low enough so that the temperature of the treated tissue does not rise above 98.6°F (36.5° C) or normal body temperature.
16034167|NCT02636764|Device|Ultrasound therapy|Ultrasound (US) is a form of mechanical energy, not electrical energy and therefore strictly speaking, not really electrotherapy at all but does fall into the Electro Physical Agents grouping.
16034168|NCT02636751|Behavioral|12-week prehabilitation program|stretching, strengthening, proprioceptive exercises of the lower limb and cardiovascular training using low-impact activities
16034169|NCT02636751|Device|Walking aid adjustment|Walking aid adjustment
16034170|NCT02636751|Behavioral|Information about pain control|General information about pain control, such as ice application and medication usage
16034171|NCT02636738|Device|Vela XL thulium laser, laser fiber and accessories.|The VelaTM XL Laser is a continuous wave thulium laser that uses an optimized 1.94μm wavelength. This powerful, highly precise laser is designed for hemostatic cutting or ablation of soft and hard tissue
16034172|NCT02636725|Drug|Axitinib|5 mg tablets twice daily oral dose administered for 7 consecutive weeks on Cycle 1. A safety lead-in consisting of the initial five patients, intrapatient dose escalation of Axitinib will be permitted based on the absence of predefined toxicities. Twice daily oral dose between 2 mg to 10 mg Axitinib tablets will be administered on subsequent 6 week cycles until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
16034173|NCT02636725|Drug|Pembrolizumab|200 mg intravenous infusion administered every 21 weeks beginning week 2 of Cycle 1 for a maximum of up to 2 years or until withdrawal of consent, disease progression and/or unacceptable toxicity as assessed by treating physician, whichever occurs first.
16034174|NCT02636712|Device|ImageReady™ MR Conditional Pacing System|
16034175|NCT02636699|Biological|Viaskin Peanut 250mcg|Peanut extract cutaneous patch
16034176|NCT02636699|Biological|Placebo|Cutaneous patch containing an inactive deposit manufactured to mimic peanut extract
16034177|NCT02636686|Drug|Drisapersen|Subjects will receive 6 mg/kg of drisapersen by subcutaneous injection once weekly. If subjects have experienced an intolerable injection site reaction(s), in consultation with the investigator, the subject may be allowed intermittent injections (8 weeks on/4 weeks off) or weekly intravenous infusions of 3 or 6 mg/kg
16034178|NCT02636673|Procedure|Sigmoid Resection|
16034179|NCT02636647|Biological|Fecal transplant|
16034180|NCT02636634|Other|imaging|
16034181|NCT02636621|Device|Brazilian Dental Appliance|Brazilian Dental Appliance is an oral appliance worn only during sleep that supports the jaw in a forward position to help maintain an open upper airway.
16034182|NCT02636621|Other|Placebo|The placebo consists in a protective dental plate worn only during sleep that do not interfere in the size of the upper airway.
16034183|NCT02636595|Drug|ABT-493/ABT-530|Tablet; ABT-493 coformulated with ABT-530
16034184|NCT02636582|Other|Laboratory Biomarker Analysis|Correlative studies
16034185|NCT02636582|Drug|Nelipepimut-S Plus GM-CSF Vaccine|Given ID
16034186|NCT02636582|Biological|Sargramostim|Given ID
16034187|NCT02636582|Procedure|Surgical Procedure|Undergo surgery
16034188|NCT02636569|Drug|topical diclofenac daily|"Topical diclofenac will be applied daily for 30 days. Each subject will be seen for a screening visit as well as a baseline visit and a visit at month 1. As part of the study small biopsies will be taken from three locations at the baseline visit. The biopsy will be taken from one actinic keratosis, one sun exposed area and one not sun exposed area. A biopsy is a small surgical procedure where a small piece of your skin is removed.
~After applying the medications for 30 days you will return to the clinic for your 30 day visit. At this visit you will again have three biopsies taken; one AK, one sun exposed, and one non sun exposed."
16034189|NCT02636569|Drug|placebo|"placebo Each subject will be seen for a screening visit as well as a baseline visit and a visit at month 1. As part of the study small biopsies will be taken from three locations at the baseline visit. The biopsy will be taken from, one actinic keratosis, one area that is typically exposed to the sun as well as a site that is typically protected from sun light. A biopsy is a small surgical procedure where a small piece of your skin is removed.
~After applying the medications for 30 days you will return to the clinic for your 30 day visit. At this visit you will again have two biopsies taken. One of these biopsies will be from the skin on your arm that was treated with medication for the prior 30 days, and the other biopsy will be from a site that typically is not exposed to the sun."
16034190|NCT02636556|Radiation|concurrent chemoradiation|The patients receive chemotherapy concurrent with Radiotherapy. The prescription dose is 60Gy in 30 fractions in 6 weeks.The chemotherapy regimen is cisplatin (25mg/m2,iv drip,d1-3) and etoposide (75mg/m2,iv drip,d1-3),q4w*4.
16034191|NCT02636543|Other|Questionnaire after the reading of letter B.|Oral questionnaire after the reading of letter B.
16034192|NCT02636543|Other|Questionnaire after the reading of letters A and B|Oral questionnaire after the reading of letters A and B during individual interview.
16034193|NCT02636530|Behavioral|Ground Reaction Forces|6 month exercise program that loads the body via gravitational forces.
16034194|NCT02636530|Behavioral|Joint Reaction Forces|6 month exercise program that loads the body via loading the joints.
16034195|NCT02636517|Biological|Fecal Microbiota Transplant|Fecal Microbiota transplant via colonoscopy, considered both a biologic and a drug
16034359|NCT02635243|Drug|SAR438544|"Pharmaceutical form:solution
~Route of administration: subcutaneous"
16034196|NCT02636504|Device|Laser Doppler Flowmetry|Pulp vitality of teeth is tested with three pulp vitality testing including laser Doppler flowmetry, cold testing, and electric pulp testing.
16034197|NCT02636491|Device|MD-Logic-Automated Insulin Delivery System|"Subjects will undergo 60 hours at home under MD-Logic control and continuing with their regular routine life. At evening of the first intervention day patients will switch to MD-Logic control. Patients will be asked to connect study sensor and pump to the computer using the MD-Logic software. After the activation of the MD-Logic system, basal insulin dosing and correction boluses will be fully automated and controlled by the MD-Logic system except to meal boluses. Patients will be encouraged to measure capillary blood glucose at least 4 times a day, before each meal and before bed time. After the third night the patient will turn the closed-loop controller OFF, this will automatically save the log file. The patient will return to his regular insulin treatment."
16034198|NCT02636491|Device|MiniMed Paradigm® Veo™ System|Subjects use 60 hours at home their conventional insulin pump and continuing with their regular Routine life. During this therapy the Insulin pump operating separately and are not controlled by the MD-Logic System.
16034199|NCT02636478|Other|questionnaire for travel habits|questionnaire has been used to collect information about travelling
16034200|NCT02636465|Other|flight simulationin obese healthy adults or obese patients with or without COPD, OHS|
16034201|NCT02636452|Other|cardiopulmonary exercise test|
16034202|NCT02636439|Behavioral|dietary, aerobic and resistance training|hypocaloric diet individual exercise prescription for aerobic training individual exercise prescription for resistance training.
16034203|NCT02636439|Behavioral|dietary, and aerobic exercise|hypocaloric diet individual prescription for aerobic training.
16034204|NCT02636426|Drug|sorafenib|In new dosing schedule of sorafenib is investigated in this study: high-dose, pulsatile sorafenib
16034205|NCT02636413|Drug|gaxilose|After gaxilose administration, urine collection, cuantification (firstly from 0 to 4 hours, and total urine from 0 to 5 hours), and xilose cuantification afterwards.
16034206|NCT02636413|Dietary Supplement|lactose|After lactose administration, expired hydrogen measurement at pre-specified intervals.
16034207|NCT02636400|Other|controlled ovarian stimulation with gonadotropins + intrauterine insemination|
16034208|NCT02636387|Drug|Desmopressin|Two desmopressin 0.2 mg tablets at bedtime for 14 days and monitoring if <50 % improvement
16034209|NCT02636374|Behavioral|Guided Imagery|A fifteen minute recording of gentle music together with soft talking to guide relaxation.
16034210|NCT02636361|Drug|LY900014|Administered subcutaneously (SC)
16034211|NCT02636361|Drug|Insulin lispro (Humalog)|Administered SC
16034212|NCT02636348|Dietary Supplement|Calcium/Vitamin D|2000 mg calcium and 1000 IU vitamin D administered daily as 8 pills or 2 fortified snack bars.
16034213|NCT02636348|Dietary Supplement|Placebo|Administered daily as 8 placebo pills or 2 unfortified snack bars.
16034214|NCT02636335|Device|Phillips Energy Light HF3319|Exposure to Light administered with Phillips Energy Light HF3319.
16034215|NCT02636322|Drug|Cyclophosphamide|Given IV
16034216|NCT02636322|Drug|Doxorubicin Hydrochloride|Given IV
16034217|NCT02636322|Drug|Etoposide|Given IV
16034218|NCT02636322|Drug|Ibrutinib|Given PO
16034219|NCT02636322|Drug|Lenalidomide|Given PO
16034220|NCT02636322|Drug|Prednisone|Given PO
16034221|NCT02636322|Biological|Rituximab|Given IV
16034222|NCT02636322|Drug|Vincristine Sulfate|Given IV
16034223|NCT02636309|Behavioral|physical therapy at work|gymnastcis, exercise orientation, ergonomics, acupuncture at work setting
16034224|NCT02636296|Other|Pilates|The Pilates program was conducted twice weekly, 60 minutes/session, for twelve consecutive weeks by a certified Pilates Instructor.
16034225|NCT02636296|Other|Control|The control group did not receive the Pilates training program and were instructed to maintain their currently activities during the twelve-week follow-up period.
16034226|NCT02636283|Drug|Entresto|Oral pills
16034227|NCT02636283|Drug|Placebo group|The placebo pills
16034228|NCT02636270|Drug|Increlex|Treat PAPP-A2 deficient patients with Increlex
16034229|NCT02636257|Procedure|Recessive Spherical Headed Silicone Intubation|Local anesthesia,regular disinfection, spread sterile towels, exposure operative side.2%lidocaine infiltration anesthesia to inferior orbital nerves, lacrimal punctum and lacrimal sac. Nasal cavity was packed with gauze soaked in 2%ephedrine with 1%tetracaine 15 minutes before procedure.A routine silicone tube of spherical intubation was performed. Dilatated lacrimal point to the end, then inserted the probe with line from lacrimal punctum to inferior meatus through nasolacrimal duct.Cut the line and flush the lacrimal duct physiological saline in 5 mL, flowing the line into the inferior meatus, then suctioned out the line with nasal endoscopy and extracted the probe and dilatated the lacrimal duct again. Insert the spherical silicone tube from lacrimal point to the lacrimal sac, reversing to vertical direction to ensure the tube is inserted into the nasolacrimal duct, then catch the above line but cut short the follow one and fix.Unobstructed lacrimal irrigation.
16034230|NCT02636257|Procedure|Dacryocystorhinostomy|Surgery was performed under local anesthesia.Incision was taken over anterior lacrimal crest.Medial palpebral ligament was identified.Orbicularis was separated.Reflection of periosteum and dissection of lacrimal sac from lacrimal fossa was done.Sac was excised to make'H'shaped anterior and posterior flaps. Bony osteum of sufficient size was made with bone punch.Nasal mucosa was cut to make anterior and posterior flaps.Subsequently anterior to anterior and posterior to posterior flaps were sutured.
16034231|NCT02636244|Drug|SHAPE Gel|
16034232|NCT02636231|Drug|Endostatins|Endostar (Endostatins) is to give from the first day of IMRT, 201mg, civ d1-14, q3w for two cycles.
16034233|NCT02636231|Radiation|IMRT|IMRT is to give GTV 60Gy in 27 fractions.
16034234|NCT02636218|Drug|Ketamine|500 ml of ketamine (0.2 mg/ml) infused at 5 ug/kg/min for 4 hours.
16034235|NCT02636218|Drug|0.9% NaCl|500 ml of 0.9% NaCl infused at 5 ug/kg/min for 4 hours.
16034236|NCT02636205|Device|Armeo therapy|Participants will receive 18 sessionsx30 mins of ArmeoSpring therapy over 6weeks.
16034237|NCT02636192|Drug|No Intervention|This is an observational study and participants did not receive any intervention in this study.
16034360|NCT02635243|Drug|r-glucagon|"Pharmaceutical form:solution
~Route of administration: subcutaneous"
16034361|NCT02635243|Drug|insulin|"Pharmaceutical form:solution
~Route of administration: intravenous"
16034238|NCT02636179|Other|Comparative epidemiological survey|The method used to select the control group will be the random sampling of eligible schools. It will be defined according to the place of schooling of the historic cohort of children. The children will be matched as close as possible based on sex, age, school class and type of school (public/private).
16034239|NCT02636166|Other|Clearblue Investigational Pregnancy test|Clearblue Investigational Pregnancy test
16034240|NCT02636166|Other|Professional pregnancy test|Alere Professional use pregnancy test
16034241|NCT02636166|Other|Clearblue Marketed Pregnancy test|Clearblue Marketed Pregnancy test
16034242|NCT02636153|Other|normal diet|Diet containing 1500mg of phosphorus
16034243|NCT02636153|Other|restricted phosphate diet|Diet containing 500mg of phosphorus
16034244|NCT02636140|Other|Light|A brief, 1 minute exposure to light of varying color and intensity. The combination of color and intensity will be the same in all participants, but the order in which they are received is randomized.
16034245|NCT02636127|Other|blood samples|"one blood sample will be done for dosage and role of Fractalkine in the serum.
~- Functional study of the interactions between T cells and NK cells and / endothelial cells (HMVEC): immuno mediated endothelial cytotoxicity, endothelial activation and microparticles release by the HMVEC, endothelial progenitor cells analysis and evaluation of the endothelial lysis by fluorescence release."
16034246|NCT02636114|Procedure|scaling and root planing|Scaling and root planing at baseline , checked clinical parameter and serum renal function markers at baseline and 1 month after therapy
16034247|NCT02636101|Drug|Calcipotriol/betamethasone dipropionate gel|Topical treatment of psoriasis plaques located on the body
16034248|NCT02636088|Drug|Cetuximab|
16034249|NCT02636049|Drug|Triferic|Triferic is supplied as sterile 5 mL ampules containing 5.44 mg/mL of iron in water for injection. Each 5 mL ampule contains 27.2 mg of Triferic iron.
16034250|NCT02636036|Biological|enadenotucirev|
16034251|NCT02636036|Biological|nivolumab|
16034252|NCT02636023|Device|SPhENo-Cardiograph|SPhENo-Cardiograph
16034253|NCT02636010|Drug|Pembrolizumab|
16034254|NCT02635997|Drug|antiresorptive therapy|
16034255|NCT02635984|Drug|Olanzapine|Olanzapine 10mg by mouth once daily on all chemotherapy days and for three days post-chemotherapy
16034256|NCT02635984|Drug|Placebo|Placebo tablet taken by mouth once daily on chemotherapy days and for 3 days post chemotherapy
16034257|NCT02635971|Procedure|Transcatheter arterial infusion|
16034258|NCT02635971|Procedure|Intravenous chemotherapy|
16034259|NCT02635971|Drug|Gemcitabine|
16034260|NCT02635971|Drug|Oxaliplatin|
16034261|NCT02635945|Drug|PBF-680|
16034262|NCT02635945|Drug|Placebo|
16034263|NCT02635932|Device|Day Splint|A thermoplastic splint was confected for each participant to stabilize the trapeziometacarpal joint, maintaining the pulp of the distal phalange of the index finger free for gripping with the other fingers and leaving the thumb in a functional position. In this group the slint was used during the daily life activities.
16034264|NCT02635932|Device|Night Splint|A thermoplastic splint was confected for each participant to stabilize the trapeziometacarpal joint, maintaining the pulp of the distal phalange of the index finger free for gripping with the other fingers and leaving the thumb in a functional position. In this group the slint was used during the night.
16034265|NCT02635919|Device|mSMART|A smartphone application that targets medication adherence in substance users, providing information and reminders and tracking medication usage and factors interfering with adherence.
16034266|NCT02635906|Other|2 hours|BED REST FOR TWO HOURS AFTER CORONARY ARTERIOGRAPHY OR CORONARY ANGIOPLASTY
16034267|NCT02635906|Other|4 hours|BED REST FOR FOUR HOURS AFTER CORONARY ARTERIOGRAPHY OR CORONARY ANGIOPLASTY
16034268|NCT02635893|Drug|D-Cycloserine|100 mg of Seromycin by mouth will be administered
16034269|NCT02635893|Drug|Placebo|placebo pill will be administered instead of medication by mouth
16034270|NCT02635893|Other|Training|walking around a designated track at different speeds both forward and backward
16034271|NCT02635893|Other|Stimulation|magnetic stimulation and electrical stimulation may be applied
16034272|NCT02635893|Other|Placebo Stimulation|this is a fake stimulation that is administered but will be unknow to the subject.
16034273|NCT02635880|Device|Investigational Enlighten Device|Up to 3 laser treatments, spaced 4 to 6 weeks apart
16034274|NCT02635867|Drug|Resin-modified calcium silicate - TheraCal LC|
16034275|NCT02635867|Drug|Calcium hydroxide - Dycal|
16034276|NCT02635867|Drug|Resin-based dentin bonding agent|
16034277|NCT02635854|Other|Septic choc group|Specific platelet activation markers, circulating leukocyte-platelet aggregates will be assessed in peripheral venous blood at the admission in intensive care unit and 48 hours later for leukocyte-platelet aggregates measurements.
16034278|NCT02635854|Other|Orthopedic surgery group|Specific platelet activation markers, circulating leukocyte-platelet aggregates will be assessed in peripheral venous blood during the orthopedic surgical anesthesia consultation.
16034279|NCT02635841|Drug|Deferiprone|Ferriprox (deferiprone) 100 mg/mL oral solution
16034280|NCT02635828|Drug|Palonosetron 0.075 mg IV|At induction of anesthesia, palonosetron 0.075 mg IV was given as PONV prophylaxis.
16034281|NCT02635828|Drug|Dexamethasone 10 mg IV|At induction of anesthesia, dexamethasone 10 mg IV was given as PONV prophylaxis.
16034282|NCT02635828|Drug|Promethazine 25 mg IV|At induction of anesthesia, promethazine 25 mg was given as PONV prophylaxis.
16034283|NCT02635815|Procedure|Upper gastrointestinal endoscopy|Upper gastrointestinal endoscopy using the Pentax video endoscope EG 3440
16034284|NCT02635802|Drug|Remifentanil|"a loading dose 1.0-2.0μg/kg remifentanil,intravenous injection slowly,time >1min,then 5μg/kg·h pumping if the operation can not be done in 5 minutes.
~Critical-Care Observation Tool(CPOT) and Richmond Agitation-Sedation Scale(RASS) are assessed before and after the loading.We should maintain the CPOT≤2 and RASS 0～2,if it is not up to the standard,increasing the pumping rate 0.5 μg/kg·h every 2-5min."
16034285|NCT02635802|Drug|Lidocaine|lidocaine 100-400mg,local anesthesia.Critical-Care Observation Tool(CPOT) and Richmond Agitation-Sedation Scale(RASS) are assessed before and after local anesthesia.We should maintain the CPOT≤2 and RASS 0～2.
16034362|NCT02635230|Drug|Combination of chronic oral anticoagulation and a P2Y12 inhibitor with or without aspirin.|
16153642|NCT01751828|Drug|Sertraline|
16034286|NCT02635802|Drug|Remifentanil+Lidocaine|a loading dose 1.0-2.0μg/kg remifentanil,intravenous injection slowly,time >1min,then 5μg/kg·h remifentanil pumping immediately if the operation can not be done in 5 minutes.then local anesthesia with lidocaine 100-400mg.Critical-Care Observation Tool(CPOT) and Richmond Agitation-Sedation Scale(RASS) are assessed before and after anesthesia.We should maintain the CPOT≤2 and RASS 0～2,if it is not up to the standard,increasing the pumping rate 0.5μg/kg·h every 2-5min.
16034287|NCT02635802|Drug|Midazolam|midazolam is an adjuvant drug.we should maintain the CPOT≤2 and RASS 0～2,if lidocaine is already used up to 400mg or the pumping rate of remifentanil is already 7.5μg/kg·h,then we should use midazolam 3mg, intravenous injection slowly.
16034288|NCT02635789|Drug|NPC-12G gel|NPC-12G gel is administered topically twice a day for 12 weeks
16034289|NCT02635789|Drug|Placebo gel|NPC-12G gel placebo is administered topically twice a day for 12 weeks
16034290|NCT02635776|Biological|AR101 powder provided in capsules & sachets|Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
16034291|NCT02635776|Biological|Placebo powder provided in capsules & sachets|Study product formulated to contain only inactive ingredients for use as defined in the protocol
16034292|NCT02635763|Procedure|Femoral nerve and the lateral cutaneous nerve block|Femoral nerve block was performed using 0.5% ropivacaine (15ml) under ultrasound guide;the lateral cutaneous nerve block was performed using 0.5% ropivacaine (5ml) under ultrasound guide
16034293|NCT02635763|Procedure|Lumbar plexus and sacral plexus nerve block|Lumbar plexus block was performed using 0.5% ropivacaine (25ml) under ultrasound guide; sacral plexus nerve block was performed using 0.5% ropivacaine (15ml) under ultrasound guide
16034294|NCT02635750|Drug|BI 409306|
16034295|NCT02635750|Drug|Donepezil low dose|
16034296|NCT02635750|Drug|Donepezil high dose|
16034297|NCT02635737|Device|Sentimark|Placement of a metallic clip with paramagnetic properties for tumour localisation
16034298|NCT02635724|Drug|Peramivir|
16034299|NCT02635711|Behavioral|Adapted Taekwondo training|Adapted Taekwondo training for beginners
16034300|NCT02635711|Behavioral|Control|Daily jogging
16034301|NCT02635698|Other|Optifast|medically-supervised weight management program
16034302|NCT02635698|Other|Food-Based|low-energy, low-fat diet
16034303|NCT02635685|Other|Clinical Decision Support tool|Automatized support tool for identification of patients with a diagnosis of atrial fibrillation without appropriate anticoagulant therapy for stroke prevention.
16034306|NCT02635659|Other|Encapsulated nutrients|
16034307|NCT02635659|Other|Placebo|
16034308|NCT02635646|Other|Family and interdisciplinary approach|"Family and interdisciplinary approach that includes:
~nutritional counseling,
~physical activity counseling,
~psychological counseling,
~metformin 850mg twice at day for 12 months All this with the purpose to improve insulin resistance and insulin secretion in patients with prediabetes. Patients must attend a monthly session together with his family where they will receive the nutritional, physical activity and psychological counseling."
16034309|NCT02635646|Other|individual approach|"individual approach that includes:
~nutritional and physical activity counseling in individual appointments,
~metformin 850mg twice at day for 12 months, All this with the purpose to improve insulin resistance and insulin secretion. The patients must attend a monthly follow-up individually."
16034310|NCT02635633|Device|continuous thetaburst stimulation|On 4 consecutive days patients receive 5 cTBS trains with a 10min intertrain-interval. One cTBS train consists of 600 pulses delivered in bursts at theta frequency (200ms) during 40s. Each burst comprises 3 pulses at 50Hz. Focal stimulation occurs over the epileptogenic focus (EF), perpendicular to the local gyral geometry, using online neuronavigation. Stimulation intensity is set relative to the resting motor threshold (rMT) determined at baseline (80% rMT). Stimulation intensity is further adjusted to the coil-cortex distance at the EF with the following formula: adjusted MT% (AdjMT) = rMT + 2,7*(DEF-DM1) [DEF = distance over EF; DM1 = distance over M1]. If rMT exceeds the capacity of the stimulator output, stimulation intensity is 100% of maximal stimulator output (MSO).
16034311|NCT02635607|Drug|Follitropin Beta|Patients will start stimulation with a daily s.c. injection of 150IU follitropin beta on menstrual cycle day 3. A modification of the rFSH dose will be allowed from stimulation day 6 onward in case that a high ovarian response occurs at the discretion of the investigator.
16034312|NCT02635607|Drug|Ganirelix|Ganirelix 0.25mg daily s.c. will start after 4 days of rFSH stimulation
16034313|NCT02635607|Drug|Ganirelix|Ganirelix 0.25mg daily s.c. will start when at least one of the following criteria are fulfilled: (i) the presence of at least one follicle measuring≥12 mm; (ii) serum E2 levels>600 pg/ml; and (iii) serum LH levels>10 IU/l.
16034314|NCT02635607|Drug|rhCG|An amount of 250ug rhCG will be administered to induce final oocyte maturation as soon as at least three follicles of ≥17 mm were observed
16034315|NCT02635607|Drug|triptorelin|0.2mg triptorelin will replace rHCG to trigger in case of high risk of overstimulation
16034316|NCT02635594|Dietary Supplement|L-Carnitine|1000mg of L-Carnitine provided as 1475mg Carnipure® tartrate
16034317|NCT02635594|Other|Placebo|1000mg cellulose + 475mg L-tartaric acid
16034318|NCT02635581|Device|Delta TT acetabular cup|
16034319|NCT02635568|Other|Cannabis Use|Observational Study
16034320|NCT02635555|Drug|Phenylephrine|100 mcg of phenylephrine or 5 mg ephedrine given as deemed necessary for treating episodes of hypotension.
16034321|NCT02635542|Drug|Succinylcholine|Succinylcholine will be used to facilitate endotracheal intubation for general anesthesia in the operating room. No additional neuromuscular blockade will be provided during general anesthesia.
16034322|NCT02635542|Drug|Cisatracurium|Cisatracurium will be used to maintain neuromuscular blockade during general anesthesia.
16034323|NCT02635529|Procedure|OFD+ DFDBA|After Phase I therapy, patient's were assigned for OFD+DFDBA group. Mucoperiosteal flap were reflected.After Open Flap Debridement (OFD), DFDBA graft was placed for the treatment of intrabony defects.
16034324|NCT02635529|Procedure|OFD+ DFDBA+ AM|After Phase I therapy, patient's were assigned for OFD+DFDBA + AM group. Mucoperiosteal flap were reflected. After Open Flap Debridement (OFD). DFDBA and AM was placed for the treatment of intrabony defects.
16034325|NCT02635516|Device|Near-Infrared Phototherapy|"The In Light Wellness Systems Near-Infrared Phototherapy Device (manufactured by In Light Wellness Systems, Inc.) contains alternating rows of 402 red (640 nm) and infrared (880 nm) light-emitting diodes embedded in 2 neoprene pads. One pad circles the skull, providing 720 Joules/min, and the other pad covers the top of the head, providing 360 joules/min. For each treatment session, the A setting on the 3-port controller is utilized, which runs approximately 6.7 min of 73 Hz, 587 Hz, and 1175 Hz in an automated sequential manner. No other interventions were utilized."
16034326|NCT02635503|Procedure|transrectal specimen extraction|After mobilization of bowel and dissection of lymph nodes, a cross clamp was placed distal to the tumor. Distal rectum was transected after fully disinfecting rectal lumen by 10% povidone-iodine. An anvil head attached to circular stapling device was put into abdominal cavity through rectal stump, and put into colon lumen through a longitudinal incision, then the proximal colon was transected in close proximity to the upper pole of incision by a linear stapling device. During specimen extraction though the rectum, a disposable sterile protective cover was used to avoid cancer cell exfoliation and implantation. The rectal opening was reclosed by a linear stapler. End-to-end colorectal anastomosis was performed with a circular stapler using the double-stapling technique.
16034327|NCT02635503|Procedure|Conventional laparoscopic surgery|High ligation of inferior mesenteric vessel , mobilization of bowel, and dissection of lymph nodes were performed laparoscopically, and total mesorectal excision with nerve-sparing technique was followed for rectal cancer. Conventional laparoscopic-assisted surgery (CLS), a small incision with a 3-7cm length was made in hypogastrium, transection of rectum was completed through abdominal incision, then the specimen was removed and the bowel was prepared for anastomosis. The anastomosis for all rectal cancer and most of sigmoid colon cancer was performed by a double-stapling technique following open resection.
16034328|NCT02635477|Behavioral|Intervention|Behavioral: actigraphy device, adaptive step count algorithm
16034329|NCT02635477|Behavioral|Control|Behavioral: actigraphy device, step count measurement only
16034330|NCT02635464|Biological|hUC-MSCs+Injectable collagen scaffold+CABG|Patients underwent Coronary Artery Bypass Surgery (CABG) with 10^8 allogeneic human umbilical cord mesenchymal stem cells (hUC-MSCs) in collagen scaffold injecting in the infarct region.
16034331|NCT02635464|Biological|hUC-MSCs+CABG|Patients underwent Coronary Artery Bypass Surgery (CABG) with 10^8 allogeneic human umbilical cord mesenchymal stem cells (hUC-MSCs) injecting in the infarct region.
16034332|NCT02635464|Procedure|CABG|Patients underwent CABG alone.
16034333|NCT02635438|Drug|Unique Pharmaceutical Laboratories, India|Clotrimazole troche/ lozenges, 10 mg 5 times a day for 14 consecutive days
16034334|NCT02635438|Drug|Roxane Laboratories Inc., USA|Clotrimazole Troche/ Lozenges USP, 10 mg 5 times a day for 14 consecutive days
16034335|NCT02635425|Procedure|7 eggs collection|vaginal US
16034336|NCT02635425|Procedure|Full eggs collection|vaginal US
16034337|NCT02635412|Other|Scheduled timing of delivery|
16034338|NCT02635399|Procedure|PPPD (pylorus-preserving pancreaticoduodenectomy)|pylorus-preserving pancreaticoduodenectomy is done in a conventional method. Additional DJ-pexy is performed for experimental group. DJ-pexy is performed by anchoring DJ site to transverse colon so that DJ is fixed to its original position.
16034339|NCT02635399|Procedure|PPPD (pylorus-preserving pancreaticoduodenectomy) with DJ-pexy|pylorus-preserving pancreaticoduodenectomy is done in a conventional method. Additional DJ-pexy is performed for experimental group. DJ-pexy is performed by anchoring DJ site to transverse colon so that DJ is fixed to its original position.
16034340|NCT02635386|Drug|Exenatide once weekly (EQW )|2 mg SC injection every 7 days
16034341|NCT02635386|Drug|Dapagliflozin (DAPA)|One pill (10 mg) by mouth daily (QD) in am
16034342|NCT02635386|Drug|EQW plus DAPA|2 mg SC injection every 7 days One pill (10 mg) by mouth QD in am
16034343|NCT02635386|Drug|Dapagliflozin plus Glucophage (MET ER)|DAPA/MET ER-5 mg /1000 mg - 1 pill by mouth in am with food for 4 weeks DAPA/MET ER-10 mg /2000 mg - 2 pills in am by mouth with food -final dose
16034344|NCT02635386|Drug|Phentermine /Topiramate (PHEN/ TPM) ER|PHEN 3.75/TPM ER 23mg - 1 pill by mouth once daily in am for 2 weeks. After 2 weeks, PHEN 7.5mg/TPM ER 46mg- 1 pill by mouth once daily in am
16034345|NCT02635360|Drug|Pembrolizumab|200 mg of study drug is given through intravenous (IV) administration once every 21 days for 3 months.
16034346|NCT02635360|Radiation|Brachytherapy|Radiation is done for standard clinical care purposes.
16034347|NCT02635360|Drug|Cisplatin|40 mg of chemotherapy drug will be given weekly for 5-6 weeks.
16034348|NCT02635347|Procedure|Remote Ischemic Conditioning (RIC)|Each RIC intervention will comprise three cycles of 5 minutes of inflation followed by 5 minutes of deflation of a pneumatic tourniquet placed in mid-thigh.
16034349|NCT02635347|Device|Pneumatic tourniquet|Portable Tourniquet System(PTSii, Delfi Medical Innovations, Inc.) used to perform RIC interventions.
16034350|NCT02635334|Drug|Montelukast 10 mg orally|
16034351|NCT02635334|Other|Placebo|
16034352|NCT02635308|Behavioral|"Unilaterally Biased Resistance Training / MOVE"|High-intensity resistance training including: whole body movement patterns, unilaterally biased lower extremity strength training, task-oriented balance tasks
16034353|NCT02635295|Behavioral|Mobile cooperation during the clinical practicum|"The intervention include (1) use of mobile application in nursing student - nurse teacher (NT) cooperation during the 5 weeks clinical practicum and (2) training at the beginning of the clinical practicum in the functions of the mobile application by the researcher.
~Students in the intervention group use mobile application for documentation of the terms of hours, learning diaries, objectives as well as mid-point and end-evaluation during the clinical practicum. NT and students have direct access to documents in the mobile application and to wireless communication regardless of time and place. The actions in the mobile application are automatically saved and shared between student and the NT."
16034354|NCT02635282|Drug|intranasal ketamine|
16034355|NCT02635282|Drug|intranasal fentanyl|
16034356|NCT02635282|Drug|intranasal midazolam|
16034357|NCT02635269|Other|Sugar|10 minutes before exercising, the subjects are given a bolus of glucose solution 0.2 g/kg in a cubital vein catheter and a constant infusion of 10% glucose solution is started (100ml/h). The infusion continues throughout the exercise period.
16034358|NCT02635256|Radiation|Hypofractionated Radiosurgery|"Image-guided stereotactic Linac based RT preferable with dedicated radiosurgery system such as CyberKnife"
16153877|NCT01750060|Drug|Fentanyl|
16034363|NCT02635217|Device|Carbon dioxide insufflation|using an automated carbon dioxide insufflator the gas will be infused on demand during the endoscopies
16034364|NCT02635217|Device|room air insufflation|using standard care room air will be infused on demand
16034365|NCT02635217|Procedure|EGD (Esophagogastroduodenoscopy) before Colonoscopy|the order of endoscopies will be randomized as well
16034366|NCT02635217|Procedure|Colonoscopy before EGD (Esophagogastroduodenoscopy)|
16034367|NCT02635204|Drug|DFD06 Cream|Twice daily topical application for 14 days.
16034368|NCT02635204|Drug|Vehicle Cream|Twice daily topical application for 14 days.
16034369|NCT02635191|Drug|Tailored Group|All the patients who enrolled in this arm will be received endoscopy followed by biopsy for antimicrobial susceptibility testing and cytochrome P450 isoenzyme 2C19 genotype. 10 days tailored therapy will be given including one Proton Pump Inhibitor ( Rabeprazole0.4-0.5mg/kg.d,bid. or Esomeprazole0.8-1.0mg/kg.d,bid) and two antibiotics (Amoxicillin30-50mg/kg.d bid, Clarithromycin15-20mg/kg.d bid, Metronidazole15-20mg/kg.d bid ) based on the cytochrome P450 isoenzyme 2C19 genotype and the antimicrobial susceptibility.
16034370|NCT02635191|Drug|Standard group|All the patients who enrolled in this arm will be treated by Omeprazole(0.8-1.0mg/kg.d,bid), Amoxicillin (30-50mg/kg.d bid)and Clarithromycin (15-20mg/kg.d bid) .
16034371|NCT02635178|Behavioral|Cognitive Anxiety Sensitivity Treatment|Cognitive Anxiety Sensitivity Treatment (CAST) is a computerized treatment designed to model the educational and behavioral techniques used in anxiety treatments. The psychoeducational component focuses on the nature of stress and its effects on the mind and body. CAST was designed to dispel myths concerning the immediate dangers of stress on cognitive processes. Individuals are taught that psychological arousal from stress is not dangerous and that they may have developed a conditioned fear to these sensations, as indicated by their elevated levels of AS cognitive concerns. In addition to psychoeducation, interoceptive exposure exercises will be introduced to correct the conditioned fear response. The program will demonstrate exercises that elicit sensations consistent with AS cognitive concerns.
16034372|NCT02635178|Behavioral|Physical Health Education Training|The Physical Health Education Training (PHET) control condition was designed to control for the effects of general education provided in the CAST condition. Participants will be presented with information regarding the importance and benefits of maintaining a healthy lifestyle. The program will discuss diet, alcohol and water consumption, exercise, sexual health, and sleep. PHET will instruct the participant how to monitor their daily health habits in order to achieve a healthy lifestyle. PHET will take approximately 45 minutes to complete. Based on the findings of Schmidt and colleagues (in press), this intervention does not appear to exert a strong effect on AS.
16034373|NCT02635165|Device|Thoracic osteosyntheses with Stracos|
16034374|NCT02635152|Behavioral|Interpretation Bias Modification|Eight 10-25 minute sessions of interpretation modification to reduce negative interpretation biases related to appearance.
16034375|NCT02635152|Behavioral|Progressive Muscle Relaxation|Eight 15-minute sessions of progressive muscle relaxation (PMR).
16034376|NCT02635139|Behavioral|Breakfast skipping|18h fasting period in the morning
16034377|NCT02635139|Behavioral|Dinner skipping|18h fasting period in the evening
16034378|NCT02635113|Device|Gait Synchronized Vibration System|A wearable vibratory shoe that delivers stimulus to the soles that is synchronized with step resulting in improved gait.The shoe consists of two externally mounted vibration units (tactors). The vibration units allow for variation of both frequency and amplitude of stimulation independently. Using the pressure sensors and timing data, gait velocity, cadence, swing time, stance phase and double support time will be analyzed to assess features of their gait performance during the Dynamic Gait Index with and without vibratory stimuli.
16034379|NCT02635100|Other|CPAP machine with MNT algorithm|"The multinight (MNT) algorithm will be evaluated on patients with Obstructive Sleep Apnea (OSA) over multiple nights while using CPAP in the home for a total of 45 days. In particular the main goal is to assess the behavior of the two main stages of the algorithm:
~Fast Track (FT) stage. Assesses if the algorithm reliably and timely reaches approximate therapeutic pressure levels.
~Slow Titration (ST) stage.Assesses if data samples are appropriately collected in a pressure range so that the therapeutic pressure can be inferred according to the algorithm proposed.
~Five days with standard auto titration.
~MNT algorithm : 7 days (maximum) with Fast Track mode, 27 days (maximum) in Slow Titration mode. After PMNT is found, the device remains at PMNT for 5 sessions. Total approximately 45 days."
16034380|NCT02635087|Device|miRNA tool|patients to be assessed by the miRNA tool. MicroRNA tool contains miRNA of miR-21、miR-20a-5p、miR-103a-3p、miR-106b-5p、miR-143-5p and miR-215. Investigators evaluate these miRNA status of surgical specimens using qRT-PCR and calculate their risk score(risk score =(0.108×status of miR-21-5p)+(0.086×status of miR-20a-5p)+(0.240×status of miR-103a-3p)+(0.095×status of miR-106b-5p)- (0.238×status of miR-143-5p)-(0.237×status of miR-215),low expression status equals 0 and high expression status equals 1.Then we determine the patients who with a score higher than 1 as exposed patient.
16034381|NCT02635074|Drug|Cytarabine|Given IV
16034382|NCT02635074|Drug|Ibrutinib|Given PO
16034383|NCT02635074|Drug|Idarubicin|Given IV
16034384|NCT02635061|Drug|ACY-241|
16034385|NCT02635061|Drug|Nivolumab|
16034386|NCT02635048|Procedure|Mini Percutaneous Nephrolithotomy|patients undergo PNCL with 18Fr nephrostomy tract
16034387|NCT02635048|Procedure|Percutaneous Nephrolithotomy|patients undergo PNCL with 24Fr nephrostomy tract
16034388|NCT02635035|Drug|Lisdexamfetamine|Vyvanse (Lisdexamfetamine Dimesylate) manufactured by Shire, is a Drug Enforcement Administration (DEA) class two,sympathomimetic amine, used for the treatment of attention-deficit hyperactivity disorder. The initial adult dosage is 30mg with allowed adjustments in increments of 10mg or 20mg at weekly intervals. Subjects are initiated on these doses and then they were titrated up by 20mg with a maximum dose of 70mg.
16034389|NCT02635035|Drug|Placebo|Placebo looks just like Vyvanse but has no active ingredients, like a sugar pill.
16034390|NCT02635009|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo PCI using 3DCRT
16034391|NCT02635009|Other|Cognitive Assessment|Ancillary studies
16034392|NCT02635009|Radiation|Intensity-Modulated Radiation Therapy|Undergo PCI with HA using IMRT
16034393|NCT02635009|Other|Laboratory Biomarker Analysis|Correlative studies
16034394|NCT02635009|Other|Quality-of-Life Assessment|Ancillary studies
16034673|NCT02633046|Drug|Acthar Gel|Acthar Gel 80 U/mL solution for subcutaneous injection
16153878|NCT01750060|Drug|Naltrexone|
16034395|NCT02634983|Drug|QVA149|QVA149 110/50 μg o.d. capsules for inhalation, supplied in blisters via the Concept 1 inhalation device, a single dose dry powder inhaler.
16034396|NCT02634983|Drug|Placebo|Matching placebo
16034397|NCT02634970|Drug|Ranibizumab|0.5 mg, intravitreal injection
16034398|NCT02634957|Behavioral|absolute voice rest|absolute voice rest is the complete elimination of any vocalization (no sounds, speaking or whispering)
16034399|NCT02634944|Diagnostic Test|Vestibular Ocular Motor Screening Tool (VOMS)|Vestibular Ocular Motor Screening Tool (VOMS)
16034400|NCT02634931|Drug|NPC-12G gel|NPC-12G gel is administered topically twice a day for 52 weeks or longer
16034401|NCT02634918|Other|ultrasound|ultrasound will be performed in hemophilia boys with a history of 20 joint bleeds- Group I, less than 2 joint bleeds into a joint -Group II and no joint bleeds- Group III
16034402|NCT02634905|Other|Individual session therapeutic education|within 2 weeks after inclusion (week 0)
16034403|NCT02634905|Other|Phone Call|
16034404|NCT02634892|Device|PRO-TECT|Patient will be placed on ROHO SOFFLEX2 mattress with has been modified with gel cushions in the sacral region for heal dissipation by standard closed system cooling pad
16034405|NCT02634879|Behavioral|Incentive Change|
16034406|NCT02634853|Drug|1% Tavilermide Ophthalmic Solution|1% Tavilermide BID Dosing
16034407|NCT02634853|Drug|Placebo Ophthalmic Solution|Vehicle Ophthalmic Solution
16034408|NCT02634840|Procedure|bilateral sagittal split osteotomy|surgical technique to split the mandibular ramus through three osteotomy lines on the medial-cranial, buccal-caudal and anterior surface to facilitate a split of the posterior border of the mandible without injury of the inferior alveolar nerve
16034409|NCT02634827|Drug|Decitabine|Given IV
16034410|NCT02634827|Other|Laboratory Biomarker Analysis|Correlative studies
16034411|NCT02634827|Drug|Midostaurin|Given PO
16034412|NCT02634814|Device|Transcutaneous Electrical Nerve Stimulation|TENS is FDA approved for the purposes in which we will be applying the modality (21CFR882.5890; http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?fr=882.5890, these TENS Units have been acquired by the PI, who is a licensed Allied Health Professional in the state of North Carolina).
16034413|NCT02634814|Other|Therapeutic Exercise|Ten sessions of TE will be provided under the supervision of a licensed Physical Therapist. Each TE Session will last 45 minutes and include open and closed chain lower extremity muscle strengthening exercises. The exercise will be progressed using the Daily Adjusted Progressive Resistive Exercise Program. The intervention will consist of 10 45-minute sessions.
16034414|NCT02634814|Device|Sham Transcutaneous Electrical Nerve Stimulation|"Sham TENS+TE patients will receive a Select System TENS unit (EMPI, Inc., St. Paul, MN) specifically configured to cease TENS current output 20 seconds after the participants initiation. For blinding purposes, patients will be told that they should feel a brief stimulation (~20 seconds) that will become sub-sensory in nature. The participants will wear the Sham TENS for 8 hours per day."
16034415|NCT02634801|Drug|Fumaric Acid Esters|Administered orally
16034416|NCT02634801|Drug|Methotrexate|Administered orally
16034417|NCT02634801|Drug|Ixekizumab|Administered SC
16034418|NCT02634788|Drug|Buprenorphine|Buprenorphine sublingual spray delivered via single 100 μL spray
16034419|NCT02634788|Drug|Placebo|Placebo-matching buprenorphine sublingual spray delivered via single 100 μL spray
16034420|NCT02634775|Other|Change in treatment strategy|Start on dialysis, transplantation, change of PD prescription, change of HD prescription
16034421|NCT02634749|Other|Systematic introduction of taste portions|A systematic introduction of plant foods from the Nordic diet
16034422|NCT02634749|Other|Protein reduced complementary foods|Specially prepared, protein-reduced, age-adjusted milk cereal drinks, baby cereals and baby milk, and commercially available baby foods in glass jars
16034423|NCT02634749|Other|Nordic diet|Taste portions, homemade and industry manufactured main meals with a predominance of Nordic ingredients
16034424|NCT02634736|Device|Exergame plus usual treatment|An individualised [i.e. frequency and duration will be set according to each participant's baseline levels] Exergame programme incorporated into participant's normal routines plus usual falls prevention treatment (prescribed by the physiotherapists).
16034425|NCT02634723|Biological|Octocog alfa (recombinant human coagulation factor VIII)|
16034426|NCT02634710|Radiation|Hypofractionated Radiation Therapy|Treatments will have a minimum of a 48-hour interfraction interval. Treatments will be completed over 20 days maximum.
16034427|NCT02634697|Behavioral|Relaxation Response Resiliency Program|8-week group intervention teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga
16034428|NCT02634684|Drug|Dextroamphetamine|Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.
16034429|NCT02634684|Drug|Placebo|Each participant receives a single pill of placebo or active drug (dextroamphetamine 10 mg) and completes approximately 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.
16034430|NCT02634671|Other|schizophrenia|The present study aims to identify the mechanisms underlying the deficit in facial emotion recognition reported both in schizophrenia with a control group using an experimental paradigm based on electroencephalography (EEG)
16034431|NCT02634671|Other|the 22q11 deletion syndrome|The present study aims to identify the mechanisms underlying the deficit in facial emotion recognition reported both in the 22q11.2 deletion syndrome with a control group using an experimental paradigm based on electroencephalography (EEG)
16034432|NCT02634671|Other|control group|The present study aims to identify the mechanisms underlying the deficit in facial emotion recognition reported both in the schizophrenia and 22q11.2 deletion syndrome with a control group using an experimental paradigm based on electroencephalography (EEG)
16034674|NCT02633020|Biological|AMG 714|Administered via a 120-minute IV infusion for a total of 7 times over 10 weeks.
16034675|NCT02633020|Biological|Placebo|Administered via a 120-minute IV infusion for a total of 7 times over 10 weeks.
16034433|NCT02634658|Other|Muscle Ultrasound|Ultrasound will be performed using a linear-array transducer with standardized gain and varying depth based on the amount of overlying soft tissue and muscle size. The subjects will be examined in the supine position with extended limbs and relaxed muscles. We will perform bilateral scans of the biceps, anterior forearm, and anterior thigh at standardized sites. For muscle echogenicity measurements, we will scan the same muscles at the same points.
16034434|NCT02634658|Other|Nerve Conduction Study|Nerve Conduction Studies will be performed using a Nicolet EDX using standard procedures. Repetitive stimulation of the median motor nerve are performed in all subjects. Bilateral sural, radial and median sensory nerves will be analyzed. We will only perform surface, not subdermal sensory recordings. The bilateral peroneal, tibial and median motor responses will be recorded over extensor digitorum brevis, abductor hallucis brevis, and abductor pollicis brevis muscles. The peroneal motor nerve will be stimulated at the fibular head and lateral popliteal fossa, recording from the tibialis anterior muscle. The compound motor action potential (CMAP) responses will be elicited from standard distal and proximal sites.
16034435|NCT02634658|Other|Electromyography|EMG studies will be performed using standard precautions. Insertional activity, spontaneous activity, motor unit potential (MUP) morphology and recruitment/activation pattern will be recorded from some combination of the deltoid, triceps, biceps, first dorsal interosseous, abductor pollicis brevis, iliopsoas, vastus medialis, and tibialis anterior muscles. The specific muscles studied for each patient will vary according to the patient's level of consciousness and ability to activate the muscles either voluntarily or during spontaneous limb movement. If possible, we will try to examine 3 unilateral upper extremity and 3 unilateral lower extremity muscles. If a patient is not able to volitionally participate in EMG testing (by contracting their muscles on command), we will analyze insertional/spontaneous activity and potentially morphology/recruitment (e.g. stroking the sole of the foot to stimulate contraction of the tibialis anterior).
16034436|NCT02634645|Procedure|Endoscopic eradication therapies (EET)|Endoscopic eradication therapies (EET) includes endoscopic mucosal resection (EMR), which describes the process by which the area most likely to harbor highest grade of dysplasia/neoplasia is removed; radiofrequency ablation (RFA), which describes the process by which Barrett's segments are removed via burning/ablation; and cryotherapy.
16034437|NCT02634645|Procedure|Esophagectomy|The esophagus is surgically removed
16034438|NCT02634645|Drug|Chemotherapy|Chemical substances are used to treat cancer
16034439|NCT02634645|Radiation|Radiation|Cancer cells are destroyed by radiation therapy.
16034440|NCT02634632|Behavioral|Choosing to write advance directives|
16034441|NCT02634619|Procedure|Ventral buccal mucosa onlay urethroplasty|Ventral buccal graft onlay involves a midline perineal incision and retraction of the bulbospongiosum muscle downward to expose the ventral urethral surface. The corpus spongiosum is incised longitudinally to expose the urethral lumen and the incision is extended proximal and distal to the established stricture. The buccal mucosa graft is harvested and trimmed to the length and width of the urethrotomy and the graft is sutured at the proximal and distal apices and a running suture at the lateral margins to establish a tight anastomosis. Ventral placement allows for limited urethral mobilization and easy access, but there is concern about higher likelihood of diverticulum formation and development of other associated complications - such as post void dribbling and ejaculatory dysfunction.
16034442|NCT02634619|Procedure|Dorsal buccal mucosa onlay urethroplasty|Dorsal buccal onlay also involves a midline perineal incision. The bulbo-cavernosum and corpora cavernosum are dissected from the bulbar urethra allowing for complete mobilization of the urethra. The urethra is rotated 180 degrees to allow for dorsal access and an incision is made on the dorsal urethra proximal and distal to the stricture location. The buccal graft is harvested and trimmed to the appropriate size of the urethrotomy and spread on the overlying tunica albuginea of the corporal bodies. The urethra is rotated back to allow for suturing of the left mucosal margin to the left margin of the buccal graft and corporal bodies, essentially covering the entire urethral plate. Dorsal placement has potential for a more stable vascular bed for graft sustainability and less spongiosal bleeding, but requires a greater urethral mobilization and longer operative times.
16034443|NCT02634606|Drug|Gamma Delta Tocotrienols - Low Dose|250 mg capsule containing 63 mg Gamma Delta Tocotrienols 2x/day for 12 weeks.
16034444|NCT02634606|Drug|Gamma Delta Tocotrienols - High Dose|250 mg capsule containing 127 mg Gamma Delta Tocotrienols 2x/day for 12 weeks.
16034445|NCT02634606|Drug|Sugar Pill|250 mg Placebo capsule containing 50% medium chain triglycerides and 50% glycerin 2x/day for 12 weeks.
16034446|NCT02634593|Behavioral|Low glycemic load snacks|Intervention to replace standard night-time food and drinks with lower glycemic load options
16034447|NCT02634580|Biological|Evolocumab|Administered by subcutaneous injection
16034448|NCT02634580|Drug|Ezetimibe|Tablet for oral administration
16034449|NCT02634580|Drug|Placebo to Evolocumab|Administered by subcutaneous injection
16034450|NCT02634580|Drug|Placebo Ezetimibe|Tablet for oral administration
16034451|NCT02634567|Behavioral|Cogmed Working Memory Training (CWMT)|The CWMT (Cogmed) method consists of 25 training sessions done online. Each participant assigned to the training group will complete eight exercises for five weeks with five sessions every week. Each session consists of a selection of various tasks that target the different aspects of attention/working memory. Participants will engage in weekly discussions over the phone for about 1 hour with an assigned Cogmed coach who will provide support and encouragement over the 5 weeks.
16034452|NCT02634541|Drug|Adalimumab|Biologic drug
16034453|NCT02634541|Other|PET/CT imaging|PET/CT imaging
16034454|NCT02634528|Drug|Julphar Insulin N (human isophane insulin)|investigational insulin: Julphar N (human isophane insulin), biosimilar
16034455|NCT02634528|Drug|Huminsulin® Basal (NPH, human isophane insulin)|marketed reference product: Huminsulin® Basal (NPH, human isophane insulin)
16034456|NCT02634515|Drug|Julphar Insulin R (soluble human insulin, biosimilar)|investigational insulin, Julphar Insulin R (soluble human insulin)
16034457|NCT02634515|Drug|Huminsulin® Normal (soluble human insulin, reference)|marketed product, Huminsulin® Normal (soluble human insulin
16034458|NCT02634502|Procedure|radiofrequency ablation|
16034459|NCT02634502|Drug|S-1|
16034460|NCT02634489|Drug|Tamsulosin HCl|Oral
16034461|NCT02634489|Drug|Solifenacin Succinate|Oral
16034462|NCT02634489|Drug|EC905|Oral
16034714|NCT02632721|Drug|BI 836858|BI 836858 weekly i.v. infusion
16034715|NCT02632708|Drug|AG-120|
16034463|NCT02634476|Behavioral|Alcohol approach/avoidance task|The approach-bias modification is a computerised alcohol approach/avoidance task (alcohol-AAT) in which participants are instructed to respond with an approach movement (pulling a joystick) to pictures in landscape orientation and an avoidance movement (pushing a joystick) to pictures in portrait orientation. The size of the image is increased and decreased by pulling and pushing the joystick respectively, generating a sensation of approach or avoidance. Pictures include images of 20 alcoholic and 20 non-alcoholic drinks presented in a fixed orientation such that participants are in effect instructed to respond to pictures of alcohol by making an avoidance movement (pushing the joystick) and to pictures of non-alcoholic soft drinks by making an approach movement (pulling the joystick).
16034464|NCT02634476|Behavioral|Sham approach/avoidance task|The computerised training for the sham condition is the same as for the experimental condition, except that in the sham approach/avoidance task, both landscape and portrait pictures all contain neutral (non-alcohol related).
16034465|NCT02634463|Drug|Aripiprazole|No study agent will be administered as a part of this study. Participants must be on Aripiprazole 5 milligram (mg) (minimum dose) to 30 mg (maximum dose), orally, daily or long-acting injectable versions (300-400 mg once every 4 weeks), as part of the treatment for a psychiatric illness to be eligible for enrollment in this study. Whole Blood and Plasma Samples will be collected for development of antipsychotic immunoassays.
16034466|NCT02634463|Other|Olanzapine|No study agent will be administered as a part of this study. Participants must be on Olanzapine 5 mg (minimum dose) to 30 mg (maximum dose), orally, daily or long-acting injectable versions (150-405 mg once every 2-4 weeks), as part of the treatment for a psychiatric illness to be eligible for enrollment in this study. Whole Blood and Plasma Samples will be collected for Development of the antipsychotic immunoassays.
16034467|NCT02634463|Drug|Paliperidone|No study agent will be administered as a part of this study. Participants must be on Paliperidone 3 mg (minimum dose) to 12 mg (maximum dose), orally, daily or long-acting injectable versions (25-150 mg equivalent [eq.] once every 4 weeks), as part of the treatment for a psychiatric illness to be eligible for enrollment in this study. Whole Blood and Plasma Samples will be collected for Development of the antipsychotic immunoassays.
16034468|NCT02634463|Drug|Risperidone|No study agent will be administered as a part of this study. Participants must be on Risperidone 1 mg (minimum dose) to 8 mg (maximum dose), orally, daily or long-acting injectable versions (12.5-50 mg once every 2 weeks), as part of the treatment for a psychiatric illness to be eligible for enrollment in this study. Whole Blood and Plasma Samples will be collected for Development of the antipsychotic immunoassays.
16034469|NCT02634450|Device|Alere q|
16034470|NCT02634437|Drug|Ulipristal acetate|
16034471|NCT02634424|Device|MyPKFiT|Adjustment of the treatment dose using a decision support software according to the PK values
16034474|NCT02634385|Procedure|Renal Artery Embolization|Patients will be receiving embolization prior to planned partial nephrectomy.
16034475|NCT02634385|Procedure|Partial Nephrectomy (Surgical Resection)|Patients will be undergoing planned partial nephrectomy post embolization.
16034476|NCT02634372|Behavioral|EMDR therapy|EMDR: We designed a specific EMDR Bipolar Protocol which consists of a detailed interview with respect to traumatic events, the treatment of those with the EMDR standard protocol, and five new specific bipolar adapted EMDR protocols focusing on adherence, insight, de-idealisation of manic symptoms, prodromal symptoms and moodstabilization.
16034477|NCT02634372|Behavioral|Supportive Therapy|Supportive therapy: Therapists adopt a client-centred focus, meaning that whatever problems the patient presents will be dealt with by providing emotional support and general advise. If no specific topic is mentioned by the patient, information about bipolar disorder and medication will be delivered by the therapist without referring to written or any other material.
16034478|NCT02634359|Device|EarlySense home device|Passive contact-free monitoring at home measuring HR, RR and movements Arms: IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF
16034479|NCT02634359|Procedure|Vaginal ultrasound|Vaginal ultrasound for the purpose of determining follicle size Arms:IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF
16034480|NCT02634359|Procedure|Blood Test|Hormonal profile blood tests arms: IVF Treatments- Frozen Embryo transfer IVF Treatments- Clinical Evaluation No IVF
16034481|NCT02634346|Drug|ALK3831|Daily dosing
16034482|NCT02634346|Drug|Olanzapine|Daily dosing
16034483|NCT02634346|Drug|Placebo|Daily dosing
16034484|NCT02634333|Procedure|Prompt Sham|A sham injection (syringe without a needle pressed against the injection site) is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter.
16034485|NCT02634333|Drug|Prompt aflibercept|Intravitreal injection of 2.0mg aflibercept is performed on the day of randomization and visits at 1, 2, and 4 months and then every 4 months thereafter.
16034486|NCT02634333|Procedure|Deferred laser|Laser (either focal/grid laser for diabetic macular edema or panretinal photocoagulation for proliferative diabetic retinopathy) is added following initiation of anti-vascular endothelial growth factor injections for center-involved diabetic macular edema or proliferative diabetic retinopathy only if certain criteria are met
16034487|NCT02634333|Drug|Deferred aflibercept|Intravitreal injection of 2.0mg aflibercept performed once proliferative diabetic retinopathy or center-involved diabetic macular edema develops and then up to every 4 weeks using defined treatment criteria.
16034488|NCT02634320|Drug|Aripiprazole Lauroxil|Monthly IM injection
16034716|NCT02632708|Drug|AG-221|
16034717|NCT02632708|Drug|cytarabine|
16034490|NCT02634294|Drug|Peg interferon alfa-2b|Eligible patients were treated with pegylated interferon alpha-2b (Peg Intron®; Schering-Plough (Brinny) Company, Innishannon, County Cork, Ireland) 1~1.5ug/kg qw, until occurrence of grade II or higher grade of acute graft versus host disease, or no response to treatment after 8 doses of treatments.
16034491|NCT02634281|Drug|Varenicline|Subjects in Group A will receive varenicline for six weeks while those in group B will receive placebo for 5 weeks and varenicline for 1 week. During this phase, subjects in both groups will be asked to reduce cigarette smoking by 50 percent. At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of varenicline treatment
16034492|NCT02634281|Drug|placebo|Subjects in Group A will receive varenicline for six weeks while those in group B will receive placebo for 5 weeks and varenicline for 1 week. During this phase, subjects in both groups will be asked to reduce cigarette smoking by 50 percent. At week 6 all participants will be instructed to stop smoking before receiving 12 weeks of varenicline treatment
16034493|NCT02634268|Behavioral|Lifestyle Intervention|Behavioral lifestyle intervention focused on healthy eating and physical activity
16034494|NCT02634255|Drug|Rocuronium elective surgery|Rocuronium onset time in patients undergoing inguinal herniorrhaphy
16034495|NCT02634255|Drug|Rocuronium emergency surgery|Rocuronium onset time in patients undergoing appendectomy
16034496|NCT02634255|Drug|Propofol|
16034497|NCT02634255|Drug|Fentanyl|
16034498|NCT02634255|Other|Ringer Lactate|
16034499|NCT02634255|Device|Acceleromyography device|
16034500|NCT02634242|Other|Si-Wu-Tang (SWT)|The purpose of the current study was to check the physiological improvement of SWT on liver and skin and also the antioxidation in healthy adults.
16034501|NCT02634242|Other|placebo|The purpose of the current study was to check the physiological improvement of placebo on liver and skin and also the antioxidation in healthy adults.
16034502|NCT02634229|Genetic|blood sample|
16034503|NCT02634216|Dietary Supplement|Capros|250 mg BID
16034504|NCT02634203|Procedure|Balloon Pulmonary Angioplasty (BPA)|Balloon pulmonary angioplasty (BPA) will be done via femoral vein. 2 sessions will be performed during the same hospitalization following by additional sessions at an interval of 2-3 weeks until a mean PAP< 30 mmHg is achieved A pulmonary angiography and a right heart catheterization will be performed at each BPA session
16034505|NCT02634203|Drug|Riociguat|The starting dose will be 1 mg three times daily as recommended. The dose will be titrated every 2 weeks according to the peripheral systolic pressure. Dose should be increased by 0.5 mg three times daily every two weeks to a maximum of 2.5 mg three times daily, if systolic blood pressure is ≥95 mmHg and the patient has no signs or symptoms of hypotension.
16034506|NCT02634190|Other|Thinprep® LBC|liquid based cytology
16034507|NCT02634190|Other|APTIMA® HPV Assay|in vitro diagnostic test
16034508|NCT02634190|Other|HR HC2® HPV DNA|in vitro diagnostic test
16034509|NCT02634190|Other|Colposcopy|Colposcopy
16034510|NCT02634177|Genetic|Assay-guided treatment (AGT)|The assay provides information to guide pharmacotherapeutic decisions personalized to a patient's genetic profile, to maximize improvement in symptomatology and minimize treatment failure and treatment intolerability.
16034511|NCT02634177|Other|Treatment-as-usual (TAU)|Subjects are treated-as-usual without the aid of the assay.
16034512|NCT02634164|Dietary Supplement|Leucine Supplement|For this visit participants will ingest a powdered form of Leucine in the amount of 0.3g/kg of lean body mass weight with water (150 mL) with additional water if needed to ensure dose is fully consumed. The amino acid solution will be ingested 30 min prior to 75 g glucose solution
16034513|NCT02634164|Dietary Supplement|Isoleucine Supplement|For this visit participants will ingest a powdered form of Isoleucine in the amount of 0.3g/kg of lean body mass weight with water (150 mL) with additional water if needed to ensure dose is fully consumed. The amino acid solution will be ingested 30 min prior to 75 g glucose solution.
16034514|NCT02634164|Dietary Supplement|Leucine Supplement combined with Isoleucine Supplement|For this visit participants will ingest a powdered form of Leucine and Isoleucine in the amount of 0.3g/kg of lean body mass weight (equal in total dosage to other treatments) with water (150 mL) with additional water if needed to ensure dose is fully consumed. The amino acid solution will be ingested 30 min prior to 75 g glucose solution.
16034515|NCT02634151|Drug|Gemcabene|Two 300 mg tablets and 1 placebo tablet administered orally, once daily for 12 weeks.
16034516|NCT02634151|Drug|Placebo|Three placebo tablets administered orally once daily for 12 weeks.
16034517|NCT02634138|Device|Revitive IX|A foot plate Neuromuscular Electrical Stimulation Device
16034518|NCT02634099|Device|blood measurement|Hemoglobin measurement
16034519|NCT02634099|Device|pulse co-oxymeter (SpHb)|non invasive method of hemoglobin measurement
16034520|NCT02634099|Device|hemoCue|non invasive method of hemoglobin measurement
16034521|NCT02634073|Drug|Lamivudine|It is a clear, colorless to pale yellow solution with the odour of fruit. It will be provided in a 240 mL bottle with the strength of 10 mg/mL Lamivudine 300 mg (30 mL of solution) will be administered orally to the participants
16034522|NCT02634073|Drug|Sorbitol|It is a clear, colorless, odourless solution. It will be available in 3 dosage levels viz;. 3.2 g (low dose), 10.2 g (medium dose) and 13.4 g (high dose) sorbitol total dose.
16034523|NCT02634060|Device|Home Based Fecal Calprotectin|Home Based Fecal Calprotectin measurement at weeks 0, 4 and 8
16034524|NCT02634047|Device|conventional technique|transesophageal echocardiography probe was inserted using a traditional blind insertion technique.
16034525|NCT02634047|Device|videolaryngoscope technique|transesophageal echocardiography probe was advanced into esophagus under direct vision using videolaryngoscope
16034526|NCT02634034|Drug|A: NK-104-CR 8 mg|NK-104-CR 8 mg (Controlled Release single 8-mg tablet)
16034527|NCT02634034|Drug|B: Pitavastatin IR 4 mg|Pitavastatin IR 4 mg (Immediate Release single 4-mg tablet)
16034528|NCT02634034|Drug|C: Pitavastatin IR 8 mg|Pitavastatin IR 8 mg (Immediate Release two 4-mg tablets)
16034529|NCT02634021|Drug|dexmedetomidine group|intravenous loading of dexmedetomidine for 1 mcg/kg
16034530|NCT02634021|Drug|midazolam group|intravenous loading of midazolam for 0.1 mg/kg
16034531|NCT02634008|Drug|Paritaprevir/ritonavir/ombitasvir|
16034532|NCT02634008|Drug|Dasabuvir|
16034533|NCT02634008|Drug|Ribavirin|
16034534|NCT02634008|Drug|Glecaprevir/pibrentasvir|
16034535|NCT02633995|Procedure|spinal anaesthesia|regional anesthesia will be induced with a total of 10 mg of 0.5% hyperbaric bupivacaine and 25 µg fentanyl (total volume 2.5 ml) at the L3-4 interspace in the sitting position then the patient will be returned immediately to the supine position with left lateral tilt.
16034536|NCT02633969|Drug|Indomethacin Capsules low dose|
16034537|NCT02633969|Drug|Indomethacin Capsules high dose|
16034538|NCT02633956|Drug|Obeticholic Acid|Once a day (QD) by mouth (PO)
16034539|NCT02633956|Drug|Atorvastatin|"Initiate treatment with Atorvastatin at Week 4 visit with a dose of 10 mg once daily (QD) by mouth (PO).
~Increase Atorvastatin to 20 mg once daily (QD) by mouth (PO) at Week 8 visit if 10 mg daily is tolerated.
~Atorvastatin may be titrated up or down at Week 12 visit as clinically indicated."
16034540|NCT02633956|Drug|Placebo|Once a day (QD) by mouth (PO)
16034541|NCT02633943|Other|Safety and efficacy assessments|Vector copy number (VCN) measurement, safety evaluations, disease-specific assessments, and assessments to monitor for long-term complications of autologous transplant
16034542|NCT02633930|Drug|Berberine|: given for 14 days at a dose of berberine 100 mg 3 tablets TID, lansoprazole 30 mg BID, amoxicillin 500 mg 2 capsules BID, and colloidal bismuth tartrate capsule55 mg 4 capsules BID
16034543|NCT02633930|Drug|clarithromycin|Clarithromycin-containing quadruple therapy group 500 mg 1 tablet BID plus amoxicillin 500 mg 2 capsules BID, lansoprazole 30mg 1tablet BID, and colloidal bismuth tartrate capsule55 mg 4 capsules BID.
16034544|NCT02633930|Drug|Bismuth|Bismuth:given for 14 days at a dose of colloidal bismuth tartrate capsule 55 mg 4 capsules BID, lansoprazole30 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID or given for 14 days at a dose of colloidal bismuth tartrate capsule 55 mg 4 capsules BID, lansoprazole30 mg BID, amoxicillin 500 mg 2 capsules BID, and berberine 100 mg 3 tablet TID
16034545|NCT02633930|Drug|Lansoprazole|Lansoprazole 30mg 1tablet BID plus amoxicillin 500 mg 2 capsules BID, clarithromycin 500 mg 1 tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or berberine 100 mg 3 tablets TID given to berberine-containing quadruple therapy group or clarithromycin-containing quadruple therapy group
16034546|NCT02633930|Drug|amoxicillin|Amoxicillin 500 mg 2 capsules BID plus lansoprazole 30mg 1tablet BID, clarithromycin 500 mg 1 tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or berberine 100 mg 3 tablets TID as a dose given for clarithromycin-containing quadruple therapy or berberine-containing quadruple therapy.
16034547|NCT02633917|Behavioral|Motor control exercises|exercises to strength the lumbar musculature and control the posture
16034548|NCT02633917|Behavioral|Standard exercises|general exercises
16034549|NCT02633904|Procedure|Osteotomy|Femoral osteotomy are applied in the open treatment of Developmental Dislocation of the Hip （DDH）.
16034550|NCT02633904|Procedure|Non-osteotomy|Femoral osteotomy are not applied in the open treatment of Developmental Dislocation of the Hip （DDH）.
16034551|NCT02633891|Behavioral|Balance exercise|tailored balance exercise program
16034552|NCT02633891|Behavioral|Standard care|general health education and fall prevention classes
16034553|NCT02633878|Drug|Chinese Herbal Medicine plus Progesterone Capsules|"New Shoutai Pill Granules plus Micronized Progesterone Capsules"
16034554|NCT02633878|Drug|Chinese Herbal Medicine Placebo plus Progesterone Capsules Placebo|"New Shoutai Pill Granules Placebo plus Micronized Progesterone Capsules Placebo"
16034555|NCT02633878|Drug|Chinese Herbal Medicine plus Progesterone Capsules Placebo|"New Shoutai Pill Granules plus Micronized Progesterone Capsules Placebo"
16034556|NCT02633878|Drug|Chinese Herbal Medicine Placebo plus Micronized Progesterone|"New Shoutai Pill Granules Placebo plus Micronized Progesterone Capsules"
16034557|NCT02633852|Drug|Aflibercept|
16034558|NCT02633839|Drug|CVT-301|Levodopa inhalation powder, will be supplied in capsules containing levodopa (l-dopa), designed to deliver to the lung using the CVT-301 inhaler.
16034559|NCT02633839|Drug|Carbidopa|Administered orally according to the carbidopa dosing schedule.
16034560|NCT02633813|Drug|Naftifine hydrochloride 2%|Topical application for two weeks
16034561|NCT02633813|Drug|Placebo|Topical application for two weeks
16034562|NCT02633813|Drug|Naftin® 2% (Naftifine hydrochloride 2%)|Topical application for two weeks
16034563|NCT02633800|Drug|Patritumab|Patritumab initial loading dose is 18 mg/kg IV over 60 minutes followed by a maintenance dose of 9 mg/kg IV over 60 minutes (± 10 minutes) every three weeks
16034564|NCT02633800|Drug|Cetuximab|Cetuximab 400 mg/mg/m^2 IV loading dose, followed by 250 mg/m^2 weekly
16034565|NCT02633800|Drug|Cisplatin|Cisplatin at 100 mg/m^2 IV infused over 1 hour, every three weeks up to a maximum of 6 cycles
16034566|NCT02633800|Drug|Carboplatin|Carboplatin IV over 30 to 60 minutes, every 3 weeks for a maximum of 6 cycles
16034567|NCT02633800|Drug|Placebo|Placebo to match patritumab
16034568|NCT02633787|Biological|Meningococcal (Groups A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine|No vaccine will be administered in this trial
16034569|NCT02633774|Drug|Propafenone|AAD(antiarrhythmic drug)
16034570|NCT02633774|Drug|Apixaban|anti-coagulation
16034571|NCT02633761|Drug|Mifepristone|200mg mifepristone followed in 24 hours by 200mcg buccal misoprostol every 3 hours.
16034572|NCT02633761|Drug|Placebo|placebo followed in 24 hours by 200mcg buccal misoprostol every 3 hours.
16034573|NCT02633761|Drug|Misoprostol 200mcg|Buccal misoprostol 200mcg
16034574|NCT02633748|Behavioral|Mindfulness-Based Cancer Survivorship|Mindfulness-Based Cancer Survivorship (MBCS) is a four-week standardized mindfulness program, adapted for cancer survivors from Mindfulness-Based Stress Reduction (MBSR). MBCS teaches formal mindfulness practice (meditation) and informal mindfulness during daily activities. Mindfulness has been shown to help stress, fatigue, sleep complaints, and other symptoms but has not been extensively studied in cancer survivors.
16034575|NCT02633735|Other|Appy CDS|See description under arm/group section
16034576|NCT02633722|Behavioral|Lifestyle intervention B|Time limiting feeding from 8-5pm (TRFb)
16034577|NCT02633722|Behavioral|Lifestyle Intervention D|Time limiting feeding (12-9pm)
16034578|NCT02633709|Drug|Itraconazole|Itraconazole will be administered as an oral 200 mg dose twice daily from Day 1 to Day 8 in Part 3.
16034579|NCT02633709|Other|Placebo|In Part 1 of the study matching oral placebo will be administered once on Day 1.
16034718|NCT02632708|Drug|daunorubicin|
16034719|NCT02632708|Drug|idarubicin|
16034580|NCT02633709|Drug|Risdiplam|Single ascending oral doses of Risdiplam will be administered on Day 1 of Part 1. In Part 2 a single dose of Risdiplam will be once administered under fasted and once under fed conditions. In Part 3 a single dose of Risdiplam will be once administered alone (Period 1) and once concomitantly to itraconazole (Period 2).
16034581|NCT02633696|Drug|silybin phosphatidylcholine|
16034582|NCT02633696|Drug|Legalón SIL|
16034583|NCT02633683|Drug|HORIZANT 600 mg|HORIZANT 600 mg once daily
16034584|NCT02633670|Device|Hemopatch|
16034585|NCT02633670|Device|No Hemopatch|
16034586|NCT02633657|Drug|HORIZANT 300 mg|HORIZANT 300 mg once daily
16034587|NCT02633644|Device|Harmony System|Percutaneous neuromodulation of the aortic wall
16034588|NCT02633618|Biological|Analgecine|Extraction from rabbit skin extract through vaccinia virus inoculation inflammation as an antigen immune reaction.
16034589|NCT02633618|Biological|Neurotropin|a natural bio-product obtained from rabbit skin extract through vaccinia virus inoculation inflammation as an antigen immune reaction.
16034590|NCT02633605|Device|First Sense Medical®|
16034591|NCT02633592|Other|HRARM|Patients and healthy volunteers are investigated in the seated and lying position during HRAM
16034592|NCT02633592|Other|MRI Defecography|Patients and healthy volunteers are investigated in the supine and left lateral position in the MRI
16034593|NCT02633579|Drug|erythromycin lactobionate|intravenous administration of erythromycin
16034594|NCT02633579|Drug|Atropine|intravenous administration of atropine
16034595|NCT02633579|Drug|Erythromycin with atropine|intravenous administration of erythromycin with saline
16034596|NCT02633579|Drug|Saline|intravenous administration of saline
16034597|NCT02633566|Device|Plantar orthoses|
16034598|NCT02633553|Radiation|adjuvant radiotherapy|50Gy/25Fx
16034599|NCT02633540|Radiation|IMRT Radiation|Radiation to Larynx
16034605|NCT02633514|Drug|Cisplatin|25mg/m2,iv gtt,d1-3
16034606|NCT02633514|Drug|Etoposide|75mg/m2,iv gtt,d1-3
16034607|NCT02633514|Radiation|radiotherapy|60Gy/30Fx
16034611|NCT02633488|Drug|Placebos|A 12 week single blind placebos
16034612|NCT02633488|Drug|metformin|A 12 week single blind metformin
16034613|NCT02633475|Genetic|IL-10 polymorphism|The IL-10 genotype will determined by polymerase chain reaction (PCR) amplication and restriction length fragment polymorphisms.
16034614|NCT02633462|Procedure|scaling and root planing , Myo-inositol|scaling and root planing along with Myo-inositol supplementation (1 gm twice a day)
16034615|NCT02633462|Drug|Myo-inositol|only provided treatment with Myo-inositol supplementation (1 gm twice a day)
16034616|NCT02633449|Behavioral|cognitive behavioral therapy|12 sessions of group cognitive behavioral therapy, six patients, two therapists, duration: 100 minutes, two sessions per week for a total of six weeks
16034617|NCT02633449|Device|tDCS|transcranial direct current stimulation during cognitive behavioral therapy with delayed onset after 10 minutes for 30 minutes, 1-2 mA, anode over electrode position F3, cathode over F4
16034618|NCT02633449|Device|sham-tDCS|sham transcranial direct current stimulation during cognitive behavioral therapy with delayed onset after 10 minutes for 30 minutes, anode over electrode position F3, cathode over F4
16034619|NCT02633436|Other|SLC1A5 expression|To observe the expression of SLC1A5 by immunohistochemistry and WesternBlot analysis.
16034620|NCT02633423|Procedure|Use of PEEP before and after CPB|PEEP will be set in order to reach an airway pressure of 5 cmH2O
16034621|NCT02633423|Procedure|No use of PEEP before and after CPB(ZEEP)|No PEEP will be used
16034622|NCT02633423|Procedure|Ventilation with CPAP during CPB|A continuous Positive Airway Pressure (CPAP) will be applied during CPB
16034623|NCT02633423|Procedure|No ventilation during CPB|No ventilation will be provided during CPB. Patients will be deconnected from ventilator. Lungs will completely collapse.
16034624|NCT02633410|Procedure|Femoral tunnel creation|Arthroscopic surgery approach used to create tunnel in femur into which graft is positioned
16034625|NCT02633397|Drug|Riociguat|Riociguat 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg three times a day for 12 weeks
16034626|NCT02633397|Drug|Placebo|Matching placebo to riociguat 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg three times a day for 12 weeks
16034627|NCT02633384|Other|SMOFlipid|Exclusive total parenteral nutrition using a new generation intravenous lipid emulsion composed of 30% LCT n-6 (soybean oil), 30% MCT (coconut oil), 25% monounsaturated fatty acids (olive oil), 15% LCT n-3 (fish oil) and α-tocopherol
16034628|NCT02633384|Other|Lipofundin|Exclusive total parenteral nutrition using a current intravenous lipid emulsion composed of 50% LCT (soybean oil) and 50% MCT (coconut oil)
16034629|NCT02633371|Drug|Oxybutynin 3% gel|
16034630|NCT02633358|Device|Therapeutic hypothermia group|Therapeutic hypothermia
16034631|NCT02633345|Dietary Supplement|Probiotic tablets|Tablets with both Lactobacillus rhamnosus PB01 and Lactobacillus curvatus P2-2. Two tablets a day for four weeks
16034632|NCT02633345|Dietary Supplement|Placebo|Placebo tablets
16034633|NCT02633319|Behavioral|Skilful Parenting|Skilful Parenting is a 2-week group-based parenting intervention delivered by Investing in Children and Our Societies to caregivers who are members of farmer groups in participating villages. It reinforces positive parenting practices, empowering parents to address the challenges that they face in bringing up their children. The intervention helps create parent peer groups to share ideas, support, information, and resources in the community. The intervention involves weekly sessions with farmer groups, awareness raising amongst local authorities and communities, and the establishment of parent peer groups. Topics consist of the following issues related to parenting: roles and responsibilities; family relations; communication; values; positive discipline; child protection; and family budgeting.
16034720|NCT02632708|Drug|mitoxantrone|
16034721|NCT02632708|Drug|etoposide|
16034634|NCT02633319|Other|Agrics|Agrics provides smallholder farmers, organized in farmer groups, with access to farm inputs on a credit basis, and agricultural extension and advisory services to improve farming techniques and improve market connections. These services include an intensive intervention during planting season and then ongoing support after the initial 3-month intervention.
16034635|NCT02633306|Device|transcranial magnetic stimulation|Treatment will consist of five daily sessions of transcranial magnetic stimulation of the motor cortex contralateral to the pain.
16034636|NCT02633293|Drug|Inhaled Treprostinil|Inhaled treprostinil (6 mcg/breath) administered four times daily
16034637|NCT02633267|Behavioral|Vocational Services as usual plus Cognitive Behavioral Therapy (CBT)|Teaches thought restructuring and exposure therapy to socially anxious job seekers delivered by vocational service professionals
16034638|NCT02633267|Behavioral|Usual Vocational Services|Vocational services delivered by vocational professionals at vocational service center (e.g., resume assistance, job leads)
16034639|NCT02633254|Device|Magnetic Resonance guided High Intensity Focused Ultrasound|Targeted vessel ablation of type 3 uterine fibroids with magnetic resonance guided high intensity focused ultrasound
16034641|NCT02633228|Device|Binocular cataract surgery with phacoemulsification and implantation of multifocal intraocular lenses|Binocular implantation of the combination of Oculentis® MplusX® multifocal intraocular lenses with an addition of +2.0 D in the distance-dominant eye and +3.0 D in the fellow eye.
16034642|NCT02633215|Device|S88 Dual Output Stimulator by Grass Technologies|Peripheral nerve stimulation of Erb's point, radial and median nerves paired with task-oriented therapy
16034643|NCT02633202|Radiation|IMRT|Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.30 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor
16034644|NCT02633202|Drug|Cisplatin|concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles during IMRT
16034645|NCT02633189|Drug|Erlotinib|given orally 150 mg daily
16034646|NCT02633189|Drug|Bevacizumab|15 mg/kg intravenously every 21 days.
16034647|NCT02633176|Drug|Cetuximab|400 mg/m^2 intravenously on day 1,then 250 mg/m^2 intravenously every week of each 21 day cycle for 6 cycles of induction chemotherapy.250 mg/m^2 intravenously every week concurrent with radiotherapy.
16034648|NCT02633176|Drug|Cisplatin|75mg/m^2 intravenously on day 1 of each 21 day cycle for 6 cycles of induction chemotherapy.30 mg/m^2 intravenously every week concurrent with radiotherapy.
16034649|NCT02633176|Drug|Docetaxel|75mg/m^2 intravenously on day 1 of each 21 day cycle for 6 cycles of induction chemotherapy.
16034650|NCT02633176|Drug|Capecitabine|1000mg/m^2 orally twice a day, days 1 to 14 of each 21 day cycle for at least 2 years or until progression following concurrent chemoradiation.
16034651|NCT02633176|Radiation|Radiotherapy|60-66 Gy if complete response or 66-70 Gy if partial response following induction chemotherapy.
16034652|NCT02633163|Drug|Low Dose Mesenchymal Stem Cells (MSCs)|Participants will receive a single IV infusion of Mesenchymal Stem Cells (MSCs) 1 x 10^6 cells/kg in Plasma-Lyte A solution. All participants will receive the infusion at the Baseline (Day 0) visit. All participants will continue on their standard-of-care therapy during the trial.
16034653|NCT02633163|Drug|High Dose Mesenchymal Stem Cells (MSCs)|Participants will receive a single IV infusion of Mesenchymal Stem Cells MSCs 5 x 10^6 cells/kg in Plasma-Lyte A solution.
16034654|NCT02633163|Drug|Placebo Infusion|Participants will receive a placebo infusion that does not contain any mesenchymal stem cells.The placebo infusion will consist of Plasma-Lyte A, which is the same vehicle used to deliver the MSCs in the experimental groups.
16034655|NCT02633150|Other|Supplementation with red grapes polyphenol|
16034656|NCT02633137|Drug|Lenalidomide|
16034657|NCT02633137|Drug|R-CHOP|"Rituximab 375 mg/m^2 IVPB with premedications Day 1
~Cyclophosphamide 750 mg/m^2 IVPB Day 1
~Doxorubicin 50 mg/m^2 IVP Day 1
~Vincristine 1.4 mg/m^2 IVP (capped at 2 mg) Day 1
~Prednisone 100 mg PO Daily on Days 1-5 or 2-6"
16034658|NCT02633137|Drug|high-dose cytarabine (HIDAC)|
16034659|NCT02633124|Device|Edelvaiss Multiline NEO|Use of Edelvaiss Multiline NEO to infuse the parenteral nutrition and drugs during the study period
16034660|NCT02633124|Device|Standard Infusion Set|Use of Standard Infusion Set to infuse the parenteral nutrition and drugs during the study period
16034661|NCT02633111|Other|collected at pre-treatment tumor biopsy|to identify the tumor-specific clonotype
16034662|NCT02633111|Other|Peripheral blood tests|for MRD analysis at 3, 6, 9, 12, 15, 18, 21, and at relapse (+/- 1 month).
16034663|NCT02633111|Device|PET/CT|at 3, 6, 9, 15, 18, 21 and at relapse(+/- 1 month)
16034664|NCT02633098|Drug|Artesunate 200mg|Artesunate 200mg PO OD for 14 days prior to colorectal resection surgery
16034665|NCT02633098|Drug|Placebo|Matched placebo PO OD for 14 days prior to colorectal resection surgery
16034667|NCT02633072|Device|Binocular cataract surgery with phacoemulsification and implantation of multifocal intraocular lenses|Binocular implantation of the combination of AMO® Tecnis® multifocal intraocular lenses with an addition of +2.75 D in the distance-dominant eye and +3.25 D in the fellow eye.
16034668|NCT02633059|Drug|Dexamethasone|Given PO
16034669|NCT02633059|Drug|Idasanutlin|Given PO
16034670|NCT02633059|Drug|Ixazomib Citrate|Given PO
16034671|NCT02633059|Other|Laboratory Biomarker Analysis|Correlative studies
16034672|NCT02633059|Other|Pharmacological Study|Correlative studies
16034676|NCT02633007|Drug|CVT-301 (levodopa inhalation powder)|Capsules containing l-dopa, designed to deliver ldopa to the lung using the CVT-301 inhaler. CVT-301 will be administered 3 times, 4 hours apart, and 1 hour following the administration of carbidopa.
16034677|NCT02633007|Drug|Carbidopa|Administered orally according to the carbidopa dosing schedule.
16034678|NCT02633007|Other|Placebo|Placebo of CVT-301 is administered in the same way as the investigational product, except that it does not contain l-dopa.
16034681|NCT02632981|Other|nonsurgical periodontal treatment|Scaling and root planning under local anaesthesia, in a total of four clinical visits Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush.
16034682|NCT02632981|Other|Gingival crevicular fluid and saliva collection|GCF collection with filter paper (Periopaper) using the intracrevicular method. Patients' mouths were rinsed with distilled water, and unstimulated salivary samples were collected by patients expectorating into disposable tubes.
16034683|NCT02632968|Procedure|Pinhole surgery with and without buttons|
16034684|NCT02632955|Drug|Drug Eluting Balloon|After pre dilation of the lesion with regular angioplasty balloon, drug coated balloon Lutonix(R) by Bard Inc. will be introduced over the lesion as quickly as possible. Lutonix is a paclitaxel coated balloon which delivers the drug locally. The diameter of the drug coated balloon will be same as the diameter of the largest balloon used for pre dilation. Drug coated balloon will be inflated not exceeding the rated burst pressure. The minimum inflation time will be 1 minute.
16034685|NCT02632955|Procedure|Regular angioplasty|After predilation of the lesion with regular balloon, the same balloon will be reintroduced without the drug to be inflated for a minimum of 1 minute. This angioplasty will not deliver any local drug.
16034686|NCT02632942|Procedure|HAQ criteria|"Obliteration of accessory vein which satisfy the HAQ criteria as below:
~60% or greater diameter of the main AVF
~50% diameter of AVF with at least one more av>40% in diameter.
~50% in diameter and divides into branches of same size.
~av likely to interfere with cannulation on physical examination.
~>30% in diameter and associated with stenosis at site of origin."
16034687|NCT02632942|Procedure|Current Recommendation|Obliteration of accessory vein which satisfy current recommendations defined as the diameter greater than 25% of the AVF diameter.
16034688|NCT02632916|Drug|Zoledronic Acid|Intravenous zoledronic acid 0.025mg/kg at baseline, 6 months, 12 months and 18 months
16034689|NCT02632916|Drug|Denosumab|Subcutaneous denosumab 1.0mg/kg at baseline, 6 months, 12 months and 18 months
16034690|NCT02632903|Drug|Zoledronic acid|
16034691|NCT02632877|Drug|Pirfenidone with MODD|Patients with diabetic foot ulcer will be treated three times a day with a smooth layer (standar finger tip unit 0.5g for an area of 100 to 120 square centimeters) of KitosCell Q (Pirfenidone with MODD) in form of gel and the wound will be covered with a bandage.
16034692|NCT02632877|Drug|Ketanserin|Patients will be administered ketanserin twice a day usign the standar finger tip unit (0.5g for an area of 100 to 120 square centimeters) and the wound will be covered with a bandage. This arm is a control for evolution of diabetic foot ulcer.
16034693|NCT02632864|Radiation|Proton arm|Proton beam therapy
16034694|NCT02632838|Device|iHealth BP7-Wireless Blood Pressure Wrist Monitor,|The mHealth group will ask to use iHealth BP7-Wireless Blood Pressure Wrist Monitor at home. This monitor is a fully automatic wrist cuff blood pressure monitor that uses the oscillometric principle to measure blood pressure and pulse rate. The monitor works with mobile devices to test, track and share vital blood pressure data. The Bluetooth sync system allows the monitor to send BP measures and pulse rate to patients' mobile devices. The free iHealth app automatically keeps a history of BP data and gives patient the option to share their blood pressure data with their provider. In addition to keep the data on the mobile device, patient also receive a free and secure cloud account. Vital data on the cloud allows patients to access from any computer and to share with their provider.
16034695|NCT02632825|Device|Nasal High Flow|Nasal High Flow Therapy
16034696|NCT02632812|Drug|Rebamipide effervescent granules|Rebamipide effervescent granules 100mg (oral), twice daily for 7 days
16034697|NCT02632812|Drug|Placebo effervescent granules|Placebo effervescent granules (oral), twice daily for 7 days
16034698|NCT02632812|Drug|Naproxen tablet|Naproxen tablet 550mg (tablet), twice daily for 7 days
16034699|NCT02632799|Device|NHF small cannula|NHF 8 l/min by Airvo 2 by small cannula
16034700|NCT02632799|Device|NHF big cannula|NHF 8 l/min by Airvo 2 by large cannula
16034701|NCT02632799|Device|CPAP|Nsal CPAP 5cm H2o by face mask
16034702|NCT02632786|Drug|NEOD001|NEOD001 is a monoclonal antibody directed at soluble and insoluble light chain aggregates
16034703|NCT02632786|Drug|Placebo|Saline Bag
16034704|NCT02632773|Behavioral|Responsive Intervention|Mothers assigned to the responsive experimental condition will learn how to talk about what is in their child's focus of attention and to respond to all child communicative attempts by either: (a) assigning a presumed meaning to preverbal communication or vocalizations or (b) by repeating the child's verbal communication and adding words.
16034705|NCT02632773|Behavioral|Directive Intervention|Mothers assigned to the directive experimental condition will learn how to: (a) set up a prompting trial through management of toys or by responding to a child request, (b) recruit the child's attention, (c) provide a discriminative stimulus (cue), (d) wait for the child's response for 5 seconds, (e) reinforce the child for correct production of the target or provide additional prompts after incorrect productions. Parents will perform one prompting trial per minute for a total of 20 trials per parent session.
16034706|NCT02632760|Drug|Ferric carboxymaltose|treatment for Iron deficient anaemia
16034707|NCT02632760|Drug|Placebo|placebo - no active drug
16034708|NCT02632747|Drug|Empagliflozin|Empagliflozin will be taken once daily
16034709|NCT02632747|Drug|Placebo (matching empagliflozin)|Placebo will be taken once daily
16034710|NCT02632747|Drug|ramipril|Ramipril will be taken once or twice daily
16034711|NCT02632734|Device|CoreBone Cone device|coral derived devices in the form of Cones are placed in extraction sites for preservation of bone during 6month and more.
16034712|NCT02632734|Device|CoreBone 500 device|coral derived devices in the form of particulate (CoreBone 500) are placed in extraction sites for preservation of bone. Follow up during 6month and more.
16034713|NCT02632721|Drug|Decitabine|
16034722|NCT02632695|Device|FOOTFIT|Individuals with venous leg ulcers will be instructed on physical activity movements for their lower legs to be performed over six weeks while wearing a foot based activity monitor (accelerometer) that will send them motivational messages and progress reports. For those in the FOOTFIT Plus group, individuals will have the option to communicate with their wound care provider via text messages, emails or phone calls.
16034723|NCT02632669|Radiation|Hemigland focal LDR brachytherapy|The treatment is limited to the hemigland that has been diagnosed with unilateral low to intermediate risk prostate cancer by means of pre-treatment staging with mpMRI and transperineal template biopsy. The affected hemigland will be treated with iodine-125 to a prescription dose of 145Gy. Patients will be assessed at baseline and subsequently at 6 weeks, 3, 6, 9, 12,18, 24 months after treatment with PSA and EN2 measurements and validated questionnaires relating to erectile, urinary, and bowel function and general health related quality of life. mpMRI and transperineal template biopsy will be performed 24 months after treatment.
16034724|NCT02632656|Other|Monitoring on heart failure therapy|This is a prospective observational study where participants will have serial blood collection on medical therapy for heart failure.
16034725|NCT02632643|Behavioral|Sensorimotor education with a view to obtaining an optimal FWS further to the relaxation of the masticatory, lingual and labial system. Learning of mandibular micro-movements in 5 directions.|
16034726|NCT02632630|Drug|Amino Acids w/Electrolytes in Dextrose|Patients will receive peripheral parenteral nutrition to a maximum of 2L/day (with a minimum rate of 45mL/hour and a maximum rate of 85mL/hour) of pre-packaged Peri-OLIMEL 2.5% E. The PPN will be administered in place of their maintenance crystalloid solution, and will be adjusted or stopped as clinically indicated by the attending medical team., for up to 5 days of hospitalization or until discharge, whichever is sooner.
16034727|NCT02632630|Dietary Supplement|Ensure product|Patients will receive one package of Ensure two times daily in hospital. At discharge, patients randomized to receive Ensure will be provided with 28 packages of Ensure with instructions to attempt to consume 1 package per day.
16034728|NCT02632630|Drug|Crystalloid solutions|Standard care intravenous maintenance fluid administration for up to 5 days of hospitalization or until discharge, whichever is sooner.
16034729|NCT02632630|Dietary Supplement|Oral nutritional supplementation|Standard of care oral nutritional supplementation is determined by the clinician. A dietitian may also be involved.
16034730|NCT02632617|Other|Computed tomographic angiography|Preoperative examination is needed in patients with valvular disease. The invasive coronary angiography is used for patients in ICA group, while the computed tomographic angiography is used as a gatekeeper and invasive coronary angiography is selectively used for patients in CTA group.
16034731|NCT02632604|Behavioral|Computerized cognitive training|40 hours of a computerized cognitive training, given 1 hour daily
16034732|NCT02632604|Behavioral|Computer games|
16034733|NCT02632578|Biological|2015 Fluvax® vaccine, BioCSL (a licensed influenza vaccine)|Subjects received licensed influenza vaccine (Fluvax®), 1ml intramuscular injection.
16034734|NCT02632565|Drug|Lidocaine|
16034735|NCT02632565|Drug|Saline|
16034736|NCT02632552|Behavioral|Technology-assisted care transition intervention|In-patient virtual nurse on-screen touchscreen and outpatient virtual nurse follow-up by texting
16034737|NCT02632552|Behavioral|Active attention control|In-patient brief animated power-point style didactic onscreen tutorial covering the core pillars of care transitions and brief outpatient texting
16034738|NCT02632539|Procedure|Manual air-impingement operation|A method which we invented to clear subglottic secretion
16034739|NCT02632539|Procedure|subglottic secretion drainage|The conventional method which we use subglottic secretion drainage to clear subglottic secretion
16034740|NCT02632526|Drug|AZD5718 oral suspension crystalline form (1 to 100 mg/mL) (Part A)|Oral suspension single dose
16034741|NCT02632526|Drug|AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part A)|Single and multiple doses
16034742|NCT02632526|Drug|AZD5718 placebo oral suspension|Single and multiple doses
16034743|NCT02632526|Drug|AZD5718 oral suspension amorphous (1 to 100 mg/mL) (Part B)|Single and multiple doses
16034744|NCT02632513|Device|Proultra PiezoFlow (Dentsply Tulsa Dental Specialties)|In continuous ultrasonic irrigation group, Proultra PiezoFlow (Dentsply Tulsa Dental Specialties, Tulsa,OK) was used for the activation of the irrigating solution according to manufacturer's recommendations.
16034745|NCT02632500|Other|Quality of chest compressions|
16034746|NCT02632487|Behavioral|Exercise|Center-based walking + balance, stretching, and light resistance
16034747|NCT02632487|Behavioral|Non-Exercise Physical Activity (NEPA)|Behavioral counseling paired with technology intervention to monitor physical activity
16034748|NCT02632474|Drug|Tenofovir(TDF)+Lamivudine(3TC)+Efavirenz(EFV)|The first 2 weeks, TDF (300 mg) + 3-TC (300 mg) + EFV (400 mg); week 3, TDF (200 mg) + 3-TC (300 mg) + EFV (400 mg ); week 4, TDF (150 mg) + 3-TC (300 mg) + EFV (400 mg).From week5, if the HIV viral load decreased as expected or no rebound, use TDF (200 mg) + 3-TC (300 mg) + EFV (400 mg) until study complete; if the viral load increases, switch to the standard treatment regimen: TDF (300 mg) + 3-TC (300 mg) + EFV (600 mg).
16034749|NCT02632461|Behavioral|Podcasts|Participants will receive twice weekly podcasts that will cover topics related to weight loss.
16034750|NCT02632461|Behavioral|Mobile Diet Application|Participants will use a mobile application on their smartphone to track their diet.
16034751|NCT02632461|Behavioral|Bite Counter|Participants will use a wrist-worn Bite Counter to track the number of bites in their diet per day.
16034752|NCT02632448|Drug|LY2880070|Capsules
16034753|NCT02632448|Drug|Gemcitabine|50 to 600 milligrams per square meter of body surface area (mg/m2)
16034754|NCT02632435|Device|PICC|Participants will be randomized to a PICC for vascular access during chemotherapy.
16034755|NCT02632435|Device|PORT|Participants will be randomized to a PORT for vascular access during chemotherapy
16034756|NCT02632422|Other|Daily acute intermittent hypoxia (dAIH)|Each participant will be exposed to 10 sessions of daily acute intermittent hypoxia (dAIH) via air generators. The generator will fill reservoir bags attached to a non-rebreathing facemask. Each session will consist of 15 episodes which include intervals of 1.5 minute hypoxia (FIO2=0.10±0.02, i.e. 10% O2) and 1 minute normoxia (FIO2=0.21±0.02). Participants will receive 5 consecutive days of daily acute intermittent hypoxia (dAIH).
16034967|NCT02631109|Drug|methylprednisolone|15 mg/kg days 1 to 3, 0.75 mg/kg days 4 to 7
16034757|NCT02632422|Other|dSHAM|Each participant will be exposed to 10 sessions of daily room air (dSHAM) via air generators. The generator will fill reservoir bags attached to a non-rebreathing facemask. Each session will consist of 15 episodes of 1.5 minute normoxia (FIO2=0.21±0.02). Participants will receive 5 consecutive days of daily room air (dSHAM).
16034758|NCT02632422|Other|Walking|"Participants will participate in 10 days of walking practice sessions. Walking practice sessions will immediately follow (within 60 minutes) the breathing intervention during training visits and will last for 60 minutes.
~Walking practice will incorporate 5 walking-related tasks:
~walking balance (e.g., walking with turns)
~skilled walking tasks (e.g., negotiating obstacles)
~walking with secondary task (e.g., walking and talking)
~endurance
~speed"
16034759|NCT02632409|Biological|Nivolumab|
16034760|NCT02632409|Other|Placebo|
16034763|NCT02632383|Device|Young with Diabetes - app|"The mHealth app Young with Diabetes containes 8 main functions:
~Contact your health care provider (ask questions, set the agenda for the next clinical visit)
~My Department (hotline numbers, videos about the new adult department, pictures of my diabetes team)
~Chatroom
~Counting Carbohydrates (information and tips about carbs, introduction to apps to count carbs, quiz)
~Knowledge-section (Text, links, tips and videos (animations and videoselfies) about What is diabetes?, Alcohol etc.)
~Tips packages (Receive a tip about alcohol, drivers license etc.)
~To parents (Text, links, tips and videoselfies to parents about what it is like to be young with diabetes and what they can do to support)
~Reminder"
16034764|NCT02632370|Drug|Gliolan®|single dose of oral 5-ALA (20mg/kg bodyweight) at 3 hours (range 2-5 hours) given preoperatively
16034765|NCT02632370|Procedure|Fluorescence-Guided Surgery|performed utilizing blue light. At least 3-5 fluorescent tissue samples will be taken.
16034766|NCT02632357|Other|Spinal Manipulation|
16034767|NCT02632344|Drug|Pembrolizumab|200 mg will be administered as a 30 minute IV infusion every 3 weeks on day 1 of each cycle after all procedures/assessments have been completed.
16034768|NCT02632331|Drug|ASP8825|Oral
16034769|NCT02632318|Device|Light|30 minutes of dawn simulation
16034770|NCT02632305|Drug|nab-paclitaxel in combination with gemcitabine + cisplatin|Patients with unresectable BTC will be treated with the triple combination of nab-paclitaxel in combination with gemcitabine + cisplatin
16034771|NCT02632292|Device|Absorb GT1|Bioresorbable vascular scaffold
16034772|NCT02632292|Device|Promus|Everolimus-eluting stent
16034773|NCT02632279|Dietary Supplement|Tryptophan (TRP) depletion|TRP depletion will be accomplished by administering a TRP-low amino acid protein drink containing 100 g of gelatin powder. The protein mixture consists of 18 amino acids. According to Dutch law, TRP is considered a food supplement and is not registered as a medicine.
16034774|NCT02632279|Dietary Supplement|Placebo|The placebo treatment will consist of an identical amino acid protein drink containing 100 g of gelatin powder to which 1.21g TRP is added.
16034775|NCT02632279|Device|Stimulator ON|Participants will be tested while their stimulator is turned ON
16034776|NCT02632279|Device|Stimulator OFF|Participans will be tested while their stimulator is turned OFF
16034777|NCT02632266|Dietary Supplement|Powder HMF|powder human milk fortifier
16034778|NCT02632266|Dietary Supplement|Liquid HMF|Liquid human milk fortifier
16034779|NCT02632253|Procedure|HIIT|High-intensity interval training (HIIT) is performed on a cycle ergometer. It consists of a 10 min warm-up followed by 4 min intervals in Zone III (at 90-95% of peak heart rate), with each interval separated by 3 min of active pauses in zone I (at 50-70% of peak heart rate). The total duration of the HIIT training is 38 min. The HIIT group will perform two supervised HIIT trainings and one self monitored MICE training per week.
16034780|NCT02632253|Other|MICE|MICE is also performed on a cycle ergometer at an intensity of 70-75% of peak heart rate for 47 min (in order for the two training protocols to be isocaloric). The control group will perform two supervised and one self monitored MICE training per week.
16034781|NCT02632240|Other|Surgery:The tunnel technique for covering gingival recession|The surgery starts with the sulcular incisions in the region of recessions, which enable access for the supraperiosteal preparation. The procedure is extended into the mucosal tissue using the tunneling knives. The partial-thickness flap is performed at the buccal site. Only the papillary regions are fully detached with the periosteum. The graft is placed into the tunnel and stabilized with absorbable sutures.The mobilized mucous flap is advanced coronally and stabilized with non-absorbable suspensory sutures.
16034782|NCT02632227|Procedure|TFU(transfontanel ultrasound)|The respiratory variation of the carotid artery blood flow peak velocity was measured using TFU before and after the fluid administration (10ml/kg for 20 min.)
16034783|NCT02632214|Other|fMRI measure|
16034784|NCT02632201|Biological|PIK-HER2|DC cell suspension (1×107 DC+ physiological saline + 0.25% human serum albumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. PIK-HER2 cell suspension (1-6×109 PIK-HER2 + physiological saline + 0.25% human serum albumin) 300ml for each infusion, IV (in the vein) for each infusion 3 cycles, each cycle received one infusions on day 21, 42, 63.
16034785|NCT02632201|Biological|DC-PMAT|DC cell suspension (1×107 DC+ physiological saline + 0.25% human serum albumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. PMAT cell suspension (1-6×109 PMAT + physiological saline + 0.25% human serum albumin) 300ml for each infusion, IV (in the vein) for each infusion 3 cycles, each cycle received one infusions on day 21, 42, 63.
16034786|NCT02632188|Procedure|Postoperative routine treatment|Postoperative routine treatment according to the hospitals local routines
16034787|NCT02632188|Biological|DC-PMAT treatment|Postoperative routine treatment according to the hospitals local routines; DC cell suspension (1×107 DC+ physiological saline + 0.25% human serum albumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. PMAT cell suspension (1-6×109 PMAT + physiological saline + 0.25% human serum albumin) 300ml for each infusion, IV (in the vein) for each infusion 3 cycles, each cycle received one infusions on day 21, 42, 63.
16034788|NCT02632175|Biological|Adalimumab|every other week or weekly subcutaneous injection
16034789|NCT02632162|Other|screening|Screening for sleep disordered breathing with the ApnoeLink Air device
16034790|NCT02632149|Device|PINS Vagus Nerve Stimulator|
16034791|NCT02632136|Drug|TAP Block Group|Transversus Abdominus Plane (TAP) block: Bupivacaine (30 ml of 0.25%)is injected between internal oblique and transveralis facia. The location of needle and the bleb that is formed after the injection is inspected under diect laparoscopic vision.
16034792|NCT02632136|Drug|Peri-Portal Block Group|15 ml of 0.5% Bupivacaine is injected in the skin and subcutaneous tissue before inserting the ports. 7 ml out of it is injected at sub-umblical port and 4 ml each a the site of other two ports.
16034793|NCT02632110|Drug|ALA|20% ALA applied to face prior to light treatment
16034794|NCT02632110|Drug|Topical Solution Vehicle|Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face prior to light treatment
16034795|NCT02632110|Device|IBL 10 mW|10 J/cm2 blue light delivered at 10 mW/cm2 for 16 minutes 40 seconds
16034796|NCT02632110|Procedure|Microneedle lesion preparation|Microneedling of all visible/palpable AK lesions prior to solution application.
16034797|NCT02632110|Device|IBL 20 mW|10 J/cm2 blue light delivered at 20 mW/cm2 for 8 minutes 20 seconds
16034798|NCT02632097|Procedure|Lichtenstein Hernioplasty with Histoacryl|"Procedure/Surgery: Lichtenstein Hernioplasty with Histoacryl:
~0.5 ml of cyanoacrylate glue is used for mesh fixation"
16034799|NCT02632097|Procedure|Lichtenstein Hernioplasty with Sutures|Procedure/Surgery: Lichtenstein Hernioplasty with Sutures: non-absorbable suture (polypropylene 2/0) is used for mesh fixation Other Name: prolene 2-0
16034800|NCT02632071|Drug|ACY-1215|An orally active, selective HDAC6 inhibitor. Assigned dosing 80 mg, 120 mg, 180 mg, 240 mg PO, once daily Days 1-21 in a 28-day cycle
16034801|NCT02632071|Drug|Nab-paclitaxel|"Taxanes are among the most widely used chemotherapy agents in the treatment of breast cancer.
~100 mg/m2 30 minute IV infusion Days 1, 8, and 15 in a 28-day cycle"
16034802|NCT02632058|Other|Cognitive Behavioral Therapy|
16034803|NCT02632045|Drug|LEE-011|600 mg capsule (3x 200 mg capsules)
16034804|NCT02632045|Drug|Fulvestrant|500 mg injection
16034805|NCT02632045|Drug|Placebo|600 mg capsule (3x 200 mg capsules)
16034806|NCT02632032|Drug|Insulin|"Monitoring insulin therapy of campers based on their usual regimen (one of the following):
~premixed insulin in the morning and evening,
~premixed insulin in the morning, regular insulin in the afternoon and premixed insulin in the evening,
~regular insulin in the morning and afternoon, and premixed insulin in the evening.
~Education of campers on different aspects of diabetes care:
~monitoring of blood glucose
~injection of insulin
~adaptation of insulin doses according to blood glucose and during exercise
~correction of hypoglycemia
~dietary advice"
16034807|NCT02632019|Drug|Gemcitabine|Gemcitabine 1000mg/m2, Physiological saline 100ml:IV (in the vein) once a week with a total of six times.
16034808|NCT02632019|Biological|Dendritic cell-precision T cell for neo-antigen combined with gemcitabine treatment|"Gemcitabine: Gemcitabine 1000mg/m2, Physiological saline 100ml: IV (in the vein) once a week with a total of six times before 60 days prior to the start of drawing blood. DC-PNAT: DC cell suspension (1×107 DC+ physiological saline + 0.25% human serum albumin) 1ml for each infusion, subcutaneous injection for each infusion, 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62.
~PNAT cell suspension (1-6×109 PNAT + physiological saline + 0.25% human serum albumin) 300ml for each infusion, IV (in the vein) for each infusion, 3 cycles, each cycle received one infusions on day 21, 42, 63."
16034809|NCT02632006|Biological|PIK-PD-1 cells|"DC cell suspension (1×10*7 DC+ physiological saline
~+ 0.25% human serum albumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. PIK-PD-1 cell suspension (1-6×10*9 PIK-PD-1 + physiological saline + 0.25% human serum albumin) 300ml for each infusion, IV (in the vein) for each infusion 3 cycles, each cycle received one infusions on day 21, 42, 63."
16034810|NCT02632006|Biological|DC-PMAT|"DC cell suspension (1×10*7 DC+ physiological saline
~+ 0.25% human serum albumin) 1ml for each infusion, subcutaneous injection for each infusion 3 cycles, each cycle received two infusions on day 19, 20; 40, 41; 61, 62. PMAT cell suspension (1-6×10*9 PMAT + physiological saline + 0.25% human serum albumin) 300ml for each infusion, IV (in the vein) for each infusion 3 cycles, each cycle received one infusions on day 21, 42, 63."
16034811|NCT02631993|Radiation|Photochemotherapy|Oral 8-Methoxypsoralene (8-MOP), (0.4-0.8 mg/kg), are given 1.5-2 hours before phototherapy. Ultraviolet light type A (UVA, 320-400 nm) is administered in a Waldmann UV1000 supine unit through 26 100-W fluorescent PUVA lamps (Waldmann F85), if needed, UVA is given in a half body unit with 15 100-W PUVA-lamps (Waldmann F85), (Waldmann UV3003K), (Waldmann, Villingen-Schwenningen, Germany). Eye protection is applied during 24 h after oral 8-MOP and the genital area are shielded in males during therapy.The UVA is initiated at 0.2-1.5 J/cm2 and is amplified by 0.25-0.5 J/cm2 after two treatments if photo toxicity is absent. PUVA is given to the patients 3-5 times each week.
16034812|NCT02631980|Drug|IV iron|Intravenous iron 15 mg/kg (max 1000 mg) in 250 ml 0.9% saline
16034813|NCT02631980|Drug|IV placebo|Intravenous 0.9% saline (250 ml)
16034814|NCT02631967|Procedure|Kono anastomosis|Kono anastomosis
16034815|NCT02631967|Procedure|Stapled side-to-side anastomosis|Stapled side-to-side anastomosis
16034816|NCT02631954|Drug|Vorico Injection 200mg(Voriconazole)|Vorico Injection 200mg(Voriconazole) to administered intravenously once
16034817|NCT02631954|Drug|Vfend®(Voriconazole) IV 200mg|Vfend®(Voriconazole) IV 200mg to administered intravenously once
16034818|NCT02631941|Drug|Z7200|
16034819|NCT02631941|Drug|Symbicort Turbohaler|
16034820|NCT02631941|Drug|Z7200 with charcoal|
16034821|NCT02631941|Drug|Symbicort Turbohaler with charcoal|
16034822|NCT02631941|Drug|Symbicort Turbohaler replicate|
16034823|NCT02631928|Drug|human biphasic insulin|investigational insulin, biosimilar human insulin suspension of 30% normal insulin and 70% basal protamined insulin
16034824|NCT02631928|Drug|human biphasic insulin, reference|marketed product, human insulin suspension of 30% normal insulin and 70% basal (NPH) insulin
16034825|NCT02631902|Behavioral|Exercise|Community-based exercise program with 3 weekly exercise sessions
16034826|NCT02631902|Behavioral|Dietary intervention|Community-based dietary intervention program
16034827|NCT02631889|Device|Transcollation technology|The use transcollation technology for dissection during lung surgery
16034828|NCT02631889|Device|Traditional electrocautery|The use of traditional Electrocautery for dissection during Lung Surgery
16034968|NCT02631096|Drug|ARB-001467|An IV infusion of ARB-001467
16034829|NCT02631876|Drug|Mirvetuximab soravtansine|Mirvetuximab Soravtansine will be administered per dose and schedule specified in the arm.
16034830|NCT02631876|Drug|Paclitaxel|Paclitaxel will be administered per dose and schedule specified in the arm.
16034831|NCT02631876|Drug|Pegylated liposomal doxorubicin|Pegylated liposomal doxorubicin will be administered per dose and schedule specified in the arm.
16034832|NCT02631876|Drug|Topotecan|Topotecan will be administered per dose and schedule specified in the arm.
16034833|NCT02631863|Drug|Aminolaevulinic acid|Aminolaevulinic acid with illumination
16034834|NCT02631863|Drug|Placebo|Placebo with illumination
16034835|NCT02631850|Behavioral|Traditional CI Therapy|Intensive in-person therapy for upper extremity hemiparesis.
16034836|NCT02631850|Behavioral|Gaming CI Therapy|Intensive remote (via video game) therapy for upper extremity hemiparesis.
16034837|NCT02631850|Behavioral|Gaming CI Therapy with Additional Contact via Video Conference|Intensive remote (via video game) therapy for upper extremity hemiparesis with additional therapist contact via video conference.
16034838|NCT02631850|Behavioral|Traditional Occupational Therapy/Physical Therapy|Traditional in-person therapy focusing on the rehabilitation of the upper extremity.
16034839|NCT02631837|Procedure|vNOTES hysterectomy|Surgical removal of the uterus by Natural Orifice Transluminal Endoscopic Surgery using a colpotomy
16034840|NCT02631837|Procedure|LSC hysterectomy|Surgical removal of the uterus by transabdominal laparoscopy
16034841|NCT02631824|Procedure|open reduction and internal fixation|Open reduction and internal fixation using an intramedullary nail
16034842|NCT02631824|Device|TFNA|Trochanteric Femoral Nail Advance
16034843|NCT02631824|Device|Augmentation (Cement)|Cement placement (3-6ml) through the cephalic blade under fluoroscopic vision. Cement contains 40% zirconuim dioxide, 15% hydroxiapatite, 45% polymethyl methacrylate (PMMA).
16034844|NCT02631811|Other|Supportive /palliative care intervention|patients will be seen by palliative care team at least once a month until the 12th week, more if needed. The symptom and suffering will be assessed by a multidisciplinary palliative specialist team of physician, nurse and psychologist. Physical, psychological, social and existential suffering will be addressed.
16034845|NCT02631798|Dietary Supplement|Food grade dye mucosal staining|mucosal staining with food grade dye
16034846|NCT02631785|Other|Cognitive Behavioral Therapy|"Psychologists will deliver the COPING CAT treatment for reducing anxiety symptoms. It is a manualized treatment that was extensively used before. The treatment will include 10- 14 sessions, mostly individual but also two parents meetings. All the treatments will occur in the Department of Psychology in Haifa University as a part of a clinical trial. The treatment will take place in a room that was designed for this purpose fully equipped with cameras, microphone and double sided mirror. All sessions will be audio and video recorded and will be closely monitored by the PI. To increase protocol adherence and verify the adequacy of the treatment delivered, all clinicians will complete routine forms with the content of each session."
16034847|NCT02631772|Drug|Sofosbuvir/Ledipasvir x 12 weeks|
16034848|NCT02631772|Drug|Sofosbuvir/Ledipasvir + Ribavirin x 12 weeks|
16034849|NCT02631759|Drug|Lévétiracetam|"Levetiracetam will be administered at 500mg / 12h through IV started within 24 hours after enrollment in the study for at least 48 hours and for up to 5 days, then a per os administration will be made out as soon as oral will be possible, at a dose of 500mg / 12h (1g / day in two divided doses ) .
~The total duration of treatment will be 1 month and 15 days taking into account the processing taking decay phase.
~The decay phase takes place in two phases:
~A phase of 7 days of levetiracetam 250 mg every 12 hours ( morning and evening)
~Then a phase of 7 days of levetiracetam 250 mg every 24 hours (evening)."
16034850|NCT02631759|Drug|Placebo|"Placebo (NaCl 0,9%) will be administered at 500mg / 12h through IV started within 24 hours after enrollment in the study for at least 48 hours and for up to 5 days, then a per os administration will be made out as soon as oral will be possible, at a dose of 500mg / 12h (1g / day in two divided doses ) .
~The total duration of treatment will be 1 month and 15 days taking into account the processing taking decay phase.
~The decay phase takes place in two phases:
~A phase of 7 days of placebo 250 mg every 12 hours ( morning and evening)
~Then a phase of 7 days of placebo 250 mg every 24 hours (evening)."
16034851|NCT02631746|Other|Laboratory Biomarker Analysis|Correlative studies
16034852|NCT02631746|Biological|Nivolumab|Given IV
16034853|NCT02631746|Other|Pharmacogenomic Study|Correlative studies
16034859|NCT02631720|Procedure|Blood Draw|
16034860|NCT02631720|Procedure|Bronchoscopy|
16034861|NCT02631707|Other|High protein diet|The intervention diet is higher in protein than the control diet.
16034862|NCT02631694|Drug|Propranolol|Intake of propranolol pill (40 milligram)
16034863|NCT02631694|Drug|Placebo|Intake of placebo pill (40 milligram)
16034864|NCT02631694|Other|Carbon dioxide|Inhalation of 35% carbon dioxide
16034865|NCT02631694|Other|Compressed air|Inhalation of air
16034866|NCT02631681|Behavioral|Group based exercise|Supervised group based combined aerobic and resistance training for 12 weeks as part of our normal clinical practice.
16034867|NCT02631668|Drug|ferrous succinate and vitamin C|As experimental group, when patients take the tablets of ferrous succinate, they also take vitamin C at the same time
16034868|NCT02631668|Drug|ferrous succinate|As active comparator, patients take the tablets of ferrous succinate with normal dosage in clinical practice
16034869|NCT02631668|Drug|ferrous succinate|As another active comparator, patients take the tablets of ferrous succinate with double dosage
16034870|NCT02631655|Other|impact of device 18F-FDOPA PET on treatment decisions|Imagery device: impact of 18F-FDOPA PET imaging on treatment decisions for patients with high-grade gliomas with an uncertain diagnosis.
16034871|NCT02631642|Drug|HMPL-689|selective PI3Kδ inhibitor
16034872|NCT02631642|Drug|HMPL-689 placebo|placebo of HMPL-689
16034873|NCT02631629|Other|Non-fortified foods|The non-fortified placebo foods are eggs, cheese, yoghurt and crisp bread (without vitamin D added).
16034969|NCT02631096|Other|Placebo|An IV infusion of placebo
16034874|NCT02631629|Other|Fortified foods|The fortified intervention foods are eggs, cheese, yoghurt and crisp bread (with about 20 mcg/day).
16034875|NCT02631616|Drug|Somatostatin|Monthly injections of Somatostatin
16034876|NCT02631603|Drug|Placebo|Administer Placebo as anti-inflammatory
16034877|NCT02631603|Drug|Prednisolone|Administer Prednisolone as anti-inflammatory
16034878|NCT02631590|Drug|Cisplatin|Cisplatin administered once as intravenous (IV) infusion over 60 minutes. Treatment is on Days 1 and 8 every 21 days.
16034879|NCT02631590|Drug|Gemcitabine|Gemcitabine administered as 30-min IV infusion. Treatment is on Days 1 and 8 every 21 days.
16034880|NCT02631590|Drug|Copanlisib|Experimental Drug: Copanlisib administered as an IV over 60-minutes beginning 1 hour after completing gemcitabine infusion. Treatment is on Days 1 and 8 every 21 days.
16034884|NCT02631551|Drug|GSP 301 NS|FDC of olopatadine HCl and mometasone furoate: 2 sprays in each nostril twice daily for 14 days
16034885|NCT02631551|Drug|Olopatadine HCl NS|2 sprays in each nostril twice daily for 14 days
16034886|NCT02631551|Drug|Mometasone furoate NS|2 sprays in each nostril twice daily for 14 days
16034887|NCT02631551|Drug|GSP 301 Placebo NS|2 sprays in each nostril twice daily for 14 days
16034888|NCT02631538|Drug|Belimumab|Belimumab will be provided as a 200 mg sterile, liquid product in a prefilled syringe. Each syringe contains 1.0 mL of 200 mg/mL belimumab. Each syringe will be a single use.
16034889|NCT02631538|Drug|Rituximab|Rituximab will be provided as a 100 mg concentrated solution for infusion. It is a clear, colorless liquid.
16034890|NCT02631538|Drug|Placebo belimumab|The placebo control will be provided as a sterile liquid product in a prefilled syringe. Each syringe will be of a single use.
16034891|NCT02631538|Drug|Placebo rituximab|Placebo rituximab will be provided as solution for infusion. It is a clear, colorless liquid.
16034892|NCT02631525|Drug|Desflurane|Balanced anesthesia with remifentanil and desflurane guided by bispectral monitoring
16034893|NCT02631525|Drug|Propofol|Total intravenous anesthesia based on propofol
16034894|NCT02631512|Device|Woulgan Gel|Primary dressing gel to be applied to the wound bed, and to be covered with a secondary bandage.
16034895|NCT02631512|Device|Intrasite Hydrogel|Primary dressing hydrogel to be applied to the wound bed, and to be covered with a secondary bandage
16034896|NCT02631499|Procedure|TACE|TACE is performed 4-6 weeks after hepatectomy. Epirubicin and lipiodol are used in TACE.
16034897|NCT02631499|Drug|Epirubicin|Epirubicin is a chemotherapy drug used in TACE
16034898|NCT02631499|Drug|lipiodol|lipiodol is a kind of embolization material used in TACE
16034899|NCT02631486|Other|Physiotherapy|Passive exercises, active exercises, strengthening, stretching
16034900|NCT02631473|Drug|50mg NANO-efavirenz|OD
16034901|NCT02631473|Drug|400mg NANO-Lopinavir|BID
16034902|NCT02631473|Drug|200mg NANO-Lopinavir|BID
16034903|NCT02631473|Drug|100mg Ritonavir|BID
16034904|NCT02631473|Drug|300mg NANO-Efavirenz|OD
16034905|NCT02631473|Drug|600mg Sustiva|OD
16034906|NCT02631473|Drug|200mg NANO-Efavirenz|OD
16034907|NCT02631473|Drug|Kaletra® (lopinavir 400mg/ritonavir 100mg)|BID
16034908|NCT02631473|Drug|+/- 200mg NANO-Lopinavir|BID
16034909|NCT02631473|Drug|+/- 200mg ritonavir NORVIR|BID
16034910|NCT02631473|Drug|400mg Sustiva|
16034911|NCT02631460|Drug|S1 80-120 mg/d|d1, every 3 weeks
16034912|NCT02631460|Drug|pemetrexed 500 mg/m2|d1, every 3 weeks
16034913|NCT02631460|Drug|carboplatin AUC=5|d1, every 3 weeks
16034914|NCT02631447|Drug|LGX818|LGX818 450 mg p.o. od
16034915|NCT02631447|Drug|MEK162|MEK162 45 mg p.o. bid
16034916|NCT02631447|Drug|Nivolumab|Nivolumab 1 mg/kg solution IV combined with ipilimumab 3 mg/kg solution IV every 3 weeks for 4 doses then nivolumab 3 mg/kg solution IV every 2 weeks
16034917|NCT02631447|Drug|Ipilimumab|Nivolumab 1 mg/kg solution IV combined with ipilimumab 3 mg/kg solution IV every 3 weeks for 4 doses then nivolumab 3 mg/kg solution IV every 2 weeks
16034918|NCT02631434|Procedure|sit-to-stand test|
16034919|NCT02631434|Procedure|six-minutes walking test|
16034920|NCT02631421|Procedure|Blood Sampling|
16034921|NCT02631421|Other|Cardiac MRI|
16034922|NCT02631408|Drug|Vancomycin|Locally, intrawound applied vancomycin powder
16034923|NCT02631395|Other|Exercise|Three teams participated in a seven--month, three--times--a--week shoulder--muscle strength--training program while three teams participated in a comparable handball training program but did not conduct any specific upper--body strength training.
16034924|NCT02631395|Other|Control group|The three teams in the Control Group trained as normal throughout the season and participated in a comparable handball training program, but did not conduct any specific upper--body strength training
16034925|NCT02631382|Procedure|wet cupping|"In double cupping (traditional technique): Cupping (suction) then scarification then cupping (suction).
~In single cupping (Asian): puncture using auto lancet then cupping (suction). In both techniques 4 out of 6 acupoints (BL23, BL24, BL25 bilateral) will be selected."
16034926|NCT02631369|Device|Heidelberg Spectralis OCT device|
16034927|NCT02631356|Drug|Ringer's lactate solution|
16034928|NCT02631356|Drug|Succinylated gelatin|
16035057|NCT02630498|Procedure|Brachial plexus block|Patients receiving brachial plexus block for hand/arm surgery
16034929|NCT02631343|Behavioral|KMC|Promotion of, and support for lactation management and skin to skin care as soon as possible after birth by study ANM supported by study ASHA in addition to routine visits by government health workers
16034930|NCT02631343|Other|Essential newborn care|
16034931|NCT02631330|Other|Multicomponent physical activity|Balance, muscle strength and aerobic capacity will be increased in intensity according Training Intervention in a Controlled Population of Frail Elderly (EMTIFE) study NCT02331459
16034932|NCT02631317|Behavioral|Advance hospital notification by EMS|Advance hospital notification by EMS
16034933|NCT02631317|Behavioral|stroke team notification|stroke team notification
16034934|NCT02631317|Behavioral|key performance indicators feedback form|"a key performance indicators real-time feedback form as continuing quality improvement"
16034935|NCT02631317|Behavioral|standard informed consent procedures|standard informed consent procedures with public poster of thrombolysis
16034936|NCT02631317|Behavioral|performance of thrombolysis at CT-room|performance of thrombolysis at CT-room or emergency room
16034937|NCT02631304|Procedure|Elective cardiac surgery|Coronary artery bypass graft (CABG), valve surgery, combined CABG-valve surgery
16034938|NCT02631291|Behavioral|Behavioral self-monitoring|Behavioral self-monitoring will teach older adults to pay attention to their daily lifestyle practices and the conditions in which they occur. Behavioral self-monitoring is crucial for detecting change early, thereby preventing complications (mental illness symptom burden) that are associated with disruptions in healthy lifestyle practices. The steps of behavioral self-monitoring include: (1) selecting a goal, (2) paying attention to some aspect of behavior, and (3) recording some details of that behavior in a diary.
16034939|NCT02631291|Behavioral|Behavioral self-monitoring + Motivational interviewing|Participants will receive the same Behavioral self-monitoring intervention; participants in this condition will interact with a 'lifestyle coach' about their recorded behaviors, weekly. The lifestyle coach will use motivational interviewing to enhance older adults' confidence and intrinsic motivation to engage in healthy lifestyle practices.
16034940|NCT02631278|Device|Intraoperative radiofrequency ablation|Intra-operative Radiofrequency ablation will be carried out and followed by surgical removal of the treated leiomyoma.
16034941|NCT02631265|Other|Exercise 1|Participants will be admitted at IRCM at 14:00. At 15:30, participant's insulin basal rate will be reduced by 80% and participants will perform a 45-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity). At 16:15, the participant's usual insulin basal rate will be set in the insulin pump and a standardized snack (30g CHO) will be served. At 16:45, the participant will be discharged and will be asked to eat a standardized dinner at home (60g CHO for females and 80g CHO for males).
16034942|NCT02631265|Other|Exercise 2|Participants will be admitted at IRCM at 14:00. At 15:10, participant's insulin basal rate will be reduced by 80%. At 15:30, participants will perform a 45-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity). At 16:15, the participant's usual insulin basal rate will be set in the insulin pump and a standardized snack (30g CHO) will be served. At 16:45, the participant will be discharged and will be asked to eat a standardized dinner at home (60g CHO for females and 80g CHO for males).
16034943|NCT02631265|Other|Exercise 3|Participants will be admitted at IRCM at 14:00. At 14:50, participant's insulin basal rate will be reduced by 80%. At 15:30, participants will perform a 45-minute exercise on the ergocycle at 60% of VO2 peak (moderate intensity). At 16:15, the participant's usual insulin basal rate will be set in the insulin pump and a standardized snack (30g CHO) will be served. At 16:45, the participant will be discharged and will be asked to eat a standardized dinner at home (60g CHO for females and 80g CHO for males).
16034944|NCT02631252|Drug|Hydroxychloroquine|Doses ranging from 600-1400mg daily in divided twice daily doses and administered orally.
16034945|NCT02631252|Drug|Mitoxantrone|Dose: 10mg/m2 IVPB in 50ml NS
16034946|NCT02631252|Drug|Etoposide|Dose: 100 mg/m2 administered intravenously in 500 ml of 0.9% sodium chloride
16034947|NCT02631239|Drug|Methotrexate|1g/m2/d IV *1d
16034948|NCT02631239|Drug|Etoposide|200mg/d PO *3d
16034949|NCT02631239|Drug|Dexamethasone|40mg/d PO *3d
16034950|NCT02631239|Drug|Pegaspargase|2500IU/m2/d IM *1d
16034951|NCT02631239|Radiation|Radiotherapy|50-56Gy
16034952|NCT02631200|Behavioral|Advance care plan|Participants will be offered the opportunity to complete an ACP by a nurse trained as an ACP facilitator, who will discuss the process with them using standard materials. At least 48 hours later, they will complete an ACP document with the help of the ACP facilitator, working together with trained expert patients who will provide peer support at the time of ACP completion and subsequently by telephone, assisted where necessary by the ACP facilitator.
16034953|NCT02631187|Device|Bielefeld balloon|Balloon Eustachian tuboplasty = dilatation of the cartilaginous Eustachian tube with a balloon catheter device performed with endoscopic control under general anaesthetic
16034954|NCT02631174|Drug|Antithrombin III|We are comparing neonates and infants on ECMP or CPB receiving ATIII, the dose of which is calculated to account for circuit volume, and compared with those not accounting for circuit volume
16034955|NCT02631161|Other|Equia Forte|Restoration of cavities with a Glasshybrid material (Equia Forte)
16034956|NCT02631161|Other|Filtek Supreme XT/Clearfil SE Bond|Restoration of cavities with a composite resin based material after placing an adhesive
16034957|NCT02631148|Drug|Melatonin|2mg controlled release melatonin tablet
16034958|NCT02631148|Drug|Placebo|placebo tablet identical to circadin
16034959|NCT02631135|Drug|Remifentanil|In case of tachycardia or hypertension the opioid dose was reduced, in case of bradycardia or hypertension the opioid dose was increased
16034960|NCT02631135|Drug|Propofol|BIS values were arranged 40-60 until the end of operation
16034961|NCT02631135|Drug|Dexmedetomidine|0.5 microgram/kg infusion, no changes
16034962|NCT02631135|Drug|Rocuronium|0.5 mg/kg iv for intubation, no change
16034963|NCT02631122|Procedure|Supraclavicular vs Retroclavicular Nerve Block|An ultrasound-guided supraclavicular or retroclavicular nerve block with 30 ml of 0.5% ropivicaine will be performed on patients scheduled for lower arm surgery; 25 ml to be delivered to the brachial plexus and 5 ml to the intercostal nerve
16034964|NCT02631109|Drug|Pegaspargase|2000U/m2 day5
16034965|NCT02631109|Drug|doxorubicin|25mg/m2 day1
16034966|NCT02631109|Drug|etoposide|100 mg/m2 was administered once on the first day of every week
16035166|NCT02629809|Drug|Ibrutinib|Given PO
16034970|NCT02631083|Other|Breakfast, lunch, snack and dinner|These meals (cereal, rice and bread meals) will be tested in subjects for their glycaemic response (CGMS) and substrate utilization (calorimeter)
16034971|NCT02631070|Drug|Luspatercept|
16034972|NCT02631070|Other|Placebo|
16034973|NCT02631057|Drug|Dabigatran|Dabigatran 110 mg capsule twice a day or 75 mg x 2 capsules twice a day
16034974|NCT02631057|Drug|Warfarin|Warfarin tablet (adjustment by each patients)
16034975|NCT02631044|Biological|JCAR017 (lisocabtagene maraleucel) single-dose schedule|Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive low-dose chemotherapy for disease control. Upon successful generation of JCAR017 product, participants will receive treatment with JCAR017 therapy. Treatment will include lymphodepleting chemotherapy followed by one dose of JCAR017 administered by intravenous (IV) injection.
16034976|NCT02631044|Biological|JCAR017 (lisocabtagene maraleucel) 2-dose schedule|Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells (PBMCs) for the production of JCAR017. During JCAR017 production, participants may receive low-dose chemotherapy for disease control. Upon product availability, participants will receive study treatment consisting of lymphodepleting chemotherapy followed by two IV doses of JCAR017.
16034977|NCT02631031|Drug|Valsartan|single oral dose of 160 mg valsartan under fasting conditions
16034978|NCT02631018|Behavioral|Standard Weight Loss Intervention|18 session, group-based, 6-month, standard behavioral weight loss intervention
16034979|NCT02631018|Behavioral|Physical Activity Enhanced Weight Loss Intervention|18 session, group-based, 6-month, physical activity enhanced behavioral weight loss intervention
16034980|NCT02631005|Other|"Walk With Ease"|Six-week walking program
16034981|NCT02630992|Drug|Amoxicillin-Clavulanate potassium|
16034982|NCT02630979|Behavioral|Measuring satisfaction, knowledge and bias|Questionnaire based assessment.
16034983|NCT02630966|Drug|Vedolizumab|Vedolizumab 300 mg IV infusion
16034984|NCT02630966|Drug|Placebo|0.9% sodium chloride IV infusion
16034985|NCT02630953|Behavioral|Original Tailored Intervention|The intervention includes regular mailings: weekly in month 1, biweekly in months 2 and 3, monthly in months 4 to 6, and a maintenance dose. Mailings consist of; 1) Manuals matched to the participant's current level of motivational readiness to change, based on TTM 2) Individually tailored computerized expert system feedback reports based on the participant's answers to monthly questionnaires. The computer expert system draws from a bank of over 330 messages developed from previous studies that address different levels of psychosocial and environmental factors affecting PA. 3) PA tip sheets addressing PA barriers specifically identified by Latinas in our formative research (e.g., caregiving duties, neighborhood safety).
16034986|NCT02630953|Behavioral|Enhanced Tailored Intervention|Participants in the Enhanced Tailored arm will receive all the intervention components of the original tailored intervention, as well as: 1) additional print materials; 2) more in-depth tailored reports; and 3) text-messages. Self-monitoring was an important aspect in increasing PA in our previous trials however, participants were only asked to turn in the self-monitoring logs once a month. Based on the importance of self-monitoring and feedback from participants (R01NR011295; R01CA15994) that they wanted greater accountability and interactivity, we added a text-message component for self-monitoring.
16034987|NCT02630927|Drug|AG-519|AG519 will be tested.
16034988|NCT02630927|Drug|Placebo|Placebo will be tested.
16034989|NCT02630914|Device|The AtriCure Synergy Ablation System|The AtriCure Synergy Ablation System will be used on all patients for AF ablation.
16034990|NCT02630901|Drug|PRX003|
16034991|NCT02630901|Other|Placebo|
16034992|NCT02630888|Drug|Memantine|Memantine association in the treatment of young patients with Bipolar I Disorder, partial responders or non-responders to the combination of (quetiapine + lithium) or (quetiapine + aripiprazole) from the ARIQUELI study.
16034993|NCT02630888|Drug|Placebo|Patients randomized to this group will receive a unit dosage identical to that contains 15 mg of memantine during the first week (V0); all have the dose of the placebo (similar to memantine) increased on the second week (V1) in two divided doses of a unit dosage identical to that contains 15 mg of memantine
16034994|NCT02630875|Drug|A4250|A4250
16034995|NCT02630862|Drug|Aspirin|Aspirin is a standard and guidelines supported therapy for patients undergoing carotid endoarterectomy as secondary prevention measure of cardiovascular risk
16034996|NCT02630862|Drug|aspirin plus dipyridamole|the combination of aspirin plus dipyridamole is approved to lower the risk of stroke in people who have had a transient ischemic attack or stroke
16034997|NCT02630849|Procedure|intercostal muscle flap and pericostal no-compression suture|intercostal muscle flap and pericostal no-compression suture of the intercostal space
16034998|NCT02630849|Procedure|Standard suture technique of the intercostal space|Standard suture technique of the intercostal space associated with an intrapleural intercostal nerve block
16034999|NCT02630836|Drug|XCEL-MT-OSTEO-BETA|XCEL-MT-OSTEO-BETA followed by endomedullary nailing
16035000|NCT02630836|Procedure|Surgical treatment|Isolated endomedullary nailing
16035001|NCT02630823|Drug|MK-3475|
16035002|NCT02630823|Procedure|Surgical resection (standard of care)|
16035003|NCT02630823|Drug|Paclitaxel (standard of care)|
16035004|NCT02630823|Drug|Carboplatin (standard of care)|
16035005|NCT02630823|Radiation|Radiation (standard of care)|
16035006|NCT02630823|Procedure|Endometrial biopsy|
16035007|NCT02630823|Procedure|Peripheral blood draw|
16035008|NCT02630810|Other|Early oral hydration|starting oral hydration 1 hour following Cesarean Section using 100 ml clear water
16035009|NCT02630810|Other|Delayed oral hydration|starting oral hydration 6 hours following Cesarean Section using 100 ml clear water
16035010|NCT02630797|Dietary Supplement|Blueberry Baseline|Before the study beginning, eligible participants will receive a radioactive tracer, Ca-41, by iv infusion. A total of 150 days will be required for the equilibration of tracer in the body i.e. elimination from soft tissue and deposition in the bone. After equilibration, a baseline period of 42 days will occur, during which no blueberry products will be provided.
16035011|NCT02630797|Dietary Supplement|Blueberry Low|One food or beverage product containing freeze-dried blueberry powder equivalent to 0.75 cups of fresh blueberries will be provided daily for 42 days.
16035167|NCT02629809|Biological|Obinutuzumab|Given IV
16035012|NCT02630797|Dietary Supplement|Blueberry Medium|Two food or beverage products containing freeze-dried blueberry powder equivalent to 1.5 cups of fresh blueberries will be provided daily for 42 days.
16035013|NCT02630797|Dietary Supplement|Blueberry High|Four food or beverage products containing freeze-dried blueberry powder equivalent to 3 cups of fresh blueberries will be provided daily for 42 days.
16035014|NCT02630784|Procedure|Non-Invasive Ventilation with Homecare ventilator|
16035015|NCT02630784|Procedure|Non-Invasive Ventilation with ICU ventilator|
16035016|NCT02630771|Procedure|Pressure pain threshold|Pressure algometry over thenar eminence, bilateral masseter muscles measured at baseline and during conditioned pain modulation
16035017|NCT02630758|Behavioral|Mindfulness-based Yoga|See study arm description.
16035018|NCT02630758|Behavioral|Walking Control Condition|See study arm description.
16035019|NCT02630745|Procedure|Immediate periodontal surgery|Treatment involves immediate surgical periodontal therapy in form of open flap debridement after non surgical endodontic treatment and obturation with gutta-percha and zinc oxide eugenol (ZOE) sealer. in concurrent endodontic periodontal lesions with communication .
16035020|NCT02630745|Procedure|Delayed periodontal surgery|Treatment involves surgical periodontal therapy after 3 months of non surgical endodontic treatment and obturation with gutta-percha and zinc oxide eugenol (ZOE) sealer. in the form of open flap debridement in concurrent endodontic periodontal lesions with communication .
16035021|NCT02630732|Behavioral|Brain school|2 sessions of education provided by a therapist. The first session one day before surgery, the other two days after surgery. Education contains physiology of the central nerve system and the pain system. Information about acute pain, chronic pain and central sensitisation.
16035022|NCT02630732|Behavioral|Back school|Two education sessions ( one day before surgery and two days after surgery) with information about the biomechanics of the lumbar spine, physiology of the spine and ergonomics.
16035023|NCT02630719|Drug|Timolol eye drops|eye drops
16035024|NCT02630719|Drug|Artificial tears|Placebo drop
16035025|NCT02630706|Drug|Ertugliflozin 5 mg|Ertugliflozin 5 mg oral tablet taken once daily
16035026|NCT02630706|Drug|Ertugliflozin 15 mg|Ertugliflozin 15 mg (5-mg and 10-mg tablets) oral taken once daily
16035027|NCT02630706|Drug|Placebo matching ertugliflozin|Placebo matching ertugliflozin (5-mg and/or 10-mg tablet) oral taken once daily
16035028|NCT02630706|Drug|Metformin|Participants are to remain on their stable doses of metformin (oral, >=1500 mg/day) while receiving blinded investigational product during the double-blind treatment period. Participants on metformin <1500 at screening are up-titrated to >= 1500 daily.
16035029|NCT02630706|Drug|Glimepiride|Glycemic rescue therapy with open-label glimepiride will be initiated in participants with glucose values exceeding protocol-specified values. Dosing and titration of open-label glimepiride rescue therapy will be at the Investigator's discretion.
16035030|NCT02630693|Drug|Palbociclib 100mg|100mg PO daily
16035031|NCT02630693|Drug|Palbociclib 125mg|125mg PO daily 3 weeks out of 4
16035032|NCT02630693|Drug|Fulvestrant or Tamoxifen or Aromatase Inhibitor|given at the standard doses/schedules
16035033|NCT02630680|Drug|Eziclen®/Izinova®|
16035034|NCT02630667|Other|SLOW Carbohydrate|Treatment consists of a carbohydrate blend designed to elicit a slow postprandial glycemic response
16035035|NCT02630667|Other|MEDIUM Carbohydrate|Treatment consists of only one carbohydrate source designed to elicit a medium/moderate postprandial glycemic response
16035036|NCT02630667|Other|FAST Carbohydrate|Treatment consists of only one carbohydrate source designed to elicit a fast postprandial glycemic response
16035037|NCT02630654|Other|This is a non-interventional study. Patients will be treated with any intervention deemed appropriate by the patient's physician.|
16035038|NCT02630641|Drug|Gonadotropin-releasing Hormone (GnRH) agonist therapy|This is a non-interventional study. Thus, investigators are free to choose GnRH agonist therapy product, and modalities of administration in accordance with local Summary of Product Characteristics.
16035039|NCT02630628|Drug|Tacrolimus|Dosage: start at 2mg twice a day, then taper as per protocol
16035040|NCT02630628|Drug|Mycophenolate mofetil|Dosage: start at 1g twice a day, then taper as per protocol
16035041|NCT02630615|Other|Blood draw|Whole blood will be collected using standard phlebotomy procedures
16035042|NCT02630602|Dietary Supplement|Functional goat cheese|60 g per day during 12 weeks
16035043|NCT02630602|Dietary Supplement|Control cheese|60 g per day during 12 weeks
16035044|NCT02630589|Device|Auditory brainstem implant|The ABI will be implanted by the neurosurgeon. The implant is fixed in a bed drilled in the parietal-temporal cortex, and the ABI electrode array is inserted into the lateral recess of the fourth ventricle and placed on the cochlear nucleus. Access to the cochlear nucleus will be made via retrosigmoid transcranial approach.
16035045|NCT02630576|Device|Neuromuscular stimulation|Single twitch and train-of-four stimulation protocols will be performed at the randomised side with growing current intensity
16035046|NCT02630563|Drug|Corticosteroids|Corticosteroids will be administered as per center practice. The choice of corticosteroid drug will also be based on center practice.
16035047|NCT02630563|Drug|Cyclosporine|Cyclosporine will be administered as per center practice.
16035048|NCT02630563|Drug|mycophenolate mofetil|Part 1: Mycophenolate mofetil will be administered as per center practice. Part 2: Mycophenolate mofetil will be administered as per dose determined in Part 1.
16035049|NCT02630550|Device|Cheetah NICOM|The Cheetah NICOM will be installed on all patients to evaluate the validity of its measurements.
16035050|NCT02630550|Device|Transesophageal echocardiography (TEE)|TEE will serve as gold standard measurements for the evaluation of the Cheetah NICOM.
16035051|NCT02630524|Behavioral|eHealth Behavioral Lifestyle Intervention Device: Telecoach|Participants will receive weekly/biweekly coaching sessions with a telecoach and use eHealth platform to log food and exercise, review daily goals, and find strategies for reaching goals.
16035052|NCT02630511|Drug|Mannitol|Mannitol consists of inhaling 0 (empty capsule acting as a placebo), 5, 10, 20, 40, 80, 160, 160, and 160 mg mannitol, resulting in a maximum cumulative dose of 635 mg
16035053|NCT02630511|Drug|Methacholine|Methacholine consists of inhaling 0.0625 mg/mL, 0.25 mg/mL, 1 mg/mL, 4 mg/mL, and 16 mg/mL
16035054|NCT02630511|Drug|Placebo|Placebo consists of inhaling humidified air
16035055|NCT02630511|Other|Rest|
16035056|NCT02630511|Other|Exercise|
16035058|NCT02630485|Behavioral|Graceful Lifestyle Changes|Participants will be educated in small groups of 8-10. A wellness booklet designed by physicians and researchers at Grace Fertility Centre will be provided.The target diet for our study is 45% carbohydrates and 55 grams of glycemic load. Participants will keep a 3-day food diary at baseline, 4, 8 and 12 weeks. Secondly, participants will be provided a pedometer and a goal to reach 10,000 steps a day. The third aspect of the program will be to decrease overall stress through mindfulness. Educational sessions will be held to teach the relaxation response and meditation techniques such as breathing and grounding exercises. Participants will be required to meditate for at least 20 minutes each day and record this.
16035059|NCT02630485|Dietary Supplement|Myo-inositol|Myo-inositol will be consumed in juice or water every morning (6 grams) for 12 weeks.
16035060|NCT02630485|Drug|Letrozole|Letrozole will be administered to patients. The initial dose will be 5 mg daily for five days and the dose can be increased by 2.5 mg to a total daily dose of 7.5 mg if necessary depending on ovulatory response, as in clinical practice. This treatment regimen will continue for three cycles (approximately the same period of time as the treatment group) or until pregnancy is achieved.
16035061|NCT02630472|Drug|Quinine Sulfate|Our plan is to first study quinine against saline to determine efficacy and safety. The vast majority of patients with rhinosinusitis utilize low pressure / high volume (240mls) sinonasal lavage to cleanse the sinonasal cavity. The patients will be exposed to a maximum of 12mls or 12.0 mg of quinine. In standard tonic water, quinine is 8.3mg/100mls and thus an 8oz glass of Canada Dry tonic water has 19.6mg of quinine. Thus, the maximum systemic exposure in our study (assuming ingestion of the total nasal administration) is less than drinking one glass of tonic water / day. To put this in context, the therapeutic range of quinine to treat malaria is 10mg/kg true ileal digestibility (TID) (2100mg for a 70kg individual) nearly 200 X the dose the investigators are proposing.
16035062|NCT02630472|Drug|Placebo|In order to blind the participants to which arm they have been randomized into, the placebo arm will contain saline solution spiked with 0.5 mg/ml sucrose octaacetate. This solution will produce a bitter flavor similar to the one produced by quinine. There is no evidence that sucrose octaacetate produces nitric oxide production in the sinonasal cavity, nor is there evidence that it has any side effects (it is used to wean babies off of pacifiers) so the investigators feel it is an effective and safe option for a placebo.
16035063|NCT02630459|Drug|Placebo|placebo via subcutaneous injection
16035064|NCT02630459|Drug|Erenumab|erenumab via subcutaneous injection
16035065|NCT02630459|Drug|Erenumab|erenumab via autoinjector (AI)/pen
16035066|NCT02630446|Other|in-home respite care program|During the respite care period, lasting at least five days, a trained or experienced care worker for persons with dementia takes over all caregiving tasks while the informal caregiver is absent. The care worker thus temporary moves into the house of the person with dementia. The care worker also writes down his/her observations in a diary as well as daily experiences and strategies on how to manage the difficult behaviors the caregivers listed before. So additionally to the provision of respite, this program also includes caregiver support and psycho-education. This support enables the caregiver to validate theirs perceptions, to learn how to deal with difficult behaviors and to feel understood by somebody.
16035067|NCT02630433|Procedure|Index cholecystectomy|Cholecystectomy performed within 48 hours after inclusion, before discharge after admission for acute biliary pancreatitis.
16035068|NCT02630433|Procedure|Scheduled cholecystectomy|Cholecystectomy performed as a scheduled procedure 6 weeks after the first admission.
16035069|NCT02630420|Drug|cetuximab and savolitinib|Dosage of combined cetuximab and savolitinib will be determine in Part 1 of the study, Part 2 will use the findings of Part 1 to further assess safety and to assess efficacy of this drug combination.
16035070|NCT02630407|Biological|viscosupplementation|A single 3 ml hyaluronic acid (HA) injection (viscosupplementation) performed the day after ACL reconstruction, after drainage removal
16035071|NCT02630407|Other|Placebo group|A single 3 ml saline injection performed the day after ACL reconstruction, after drainage removal
16035072|NCT02630394|Drug|Azithromycin|
16035073|NCT02630381|Device|Unfocused extracoporeal shock wave therapy|"Shock waves are acoustical pulses that are characterized by high amplitude (~500 bar) and short rise time (~20 ns), which are followed by a longer low-magnitude negative wave (~-100 bar). Extracorporeal shock waves are widely used to disintegrate kidney stones, which is called lithotripsy. In orthopedics, shock wave therapy, called orthotripsy, is used safely in a variety of musculoskeletal disorders like non unions, osteonecrosis of the hip, Achilles and patellar tendinopathy, lateral epicondylitis of the elbow and fasciitis plantaris.
~Until recently extracorporeal shock wave therapy for musculoskeletal disorders was applied with a focused character, in which the waves converge in a focal point similar to lithotripsy. For the prevention of fractures in osteoporosis a focused character is not preferable because large skeletal regions have to be treated, so unfocused shock waves have been developed."
16035074|NCT02630368|Drug|Cyclophosphamide and JX-594 dose escalation|Metronomic cyclophosphamide will be administered orally, 50 mg twice daily, one week on/one week off. JX-594 will be administered, as designated by assigned dose-level, intraveinously, on Days 8 and 22 of cycle 1, and on days 8 of each subsequent cycles. One cycle consits of 28 days.
16035075|NCT02630368|Drug|Cyclophosphamide and JX-594|Metronomic cyclophosphamide will be administered orally, 50 mg twice daily, one week on/one week off. JX-594 will be administered, as the dose recommended in the experimental phase I dose escalating study, intraveinously, on Days 8 and 22 of cycle 1, and on days 8 of each subsequent cycles. One cycle consits of 28 days.
16035076|NCT02630368|Drug|Cyclophosphamide|Metronomic cyclophosphamide will be administered orally, 50 mg twice daily, one week on/one week off.
16035077|NCT02630368|Drug|Avelumab and JX-594 and Cyclophosphamide|"Avelumab will be administered by intravenous infusion (10 mg/kg) every 2 weeks, starting at Day 15 of cycle 1.
~Cyclophosphamide wil be administered bi-daily (50 mg x 2), starting 7 days prior to cycle 1 day 1 (impregnation phase) and given on a week on/week off schedule.
~JX-594 will be administered by intratumoral injection (1 x109 p.f.u) on day 1 of cycle 1, every 2 weeks, for a maximum of 4 injections ."
16035078|NCT02630355|Other|Remote Ischaemic Preconditioning|Inflation of blood pressure cuff in lower limb
16035079|NCT02630342|Behavioral|Mock MRI scanner|Using a mock scanner for preparation for MRI
16035080|NCT02630342|Behavioral|Preparation materials|links to online videos about MRI, audio files with scanner noises, and a childrens book about MRI scan.
16035168|NCT02629796|Other|CIDP treated (IVIG)|usual treatment with intravenous immunoglobulin
16035081|NCT02630342|Behavioral|Child Life Specialist preparation|Child Life Therapist will coordinate the prepartion of the child
16035082|NCT02630342|Behavioral|Review Preparation Materials|Review of preparation materials at the hospital with member of research team
16035083|NCT02630329|Procedure|vNOTES adnexectomy|Surgical removal of one or both adnexa by a natural orifice transluminal endoscopic surgical technique using a colpotomy (transvaginal incision)
16035084|NCT02630329|Procedure|Laparoscopic adnexectomy|Surgical removal of one or both adnexa by transabdominal laparoscopy
16035087|NCT02630303|Device|LED-RL Phototherapy|"The maximum recommended starting dose (MSRD) (160 J/cm2) will be administered to Group 1's LED-RL phototherapy randomized subjects and the LED-RL dose will be escalated in subsequent groups using the classical method for dose escalation as described by Spilker: starting with dose (X) increased by an equal amount (in this instance: X=160 J/cm2, 2X=320 J/cm2, 3X=480 J/cm2, 4X=640 J/cm2). Common expected procedure side effects are mild and temporary, including warmth, redness (erythema) and swelling (edema). The maximally tolerated dose (MTD) is defined as the dose level below the dose producing unacceptable but reversible toxicity and is considered the upper limit of subject tolerance.
~All subjects will receive total of nine LED-RL phototherapy, three times per week for three consecutive weeks."
16035088|NCT02630303|Device|Mock Therapy|"Mock therapy will be administered to mock therapy randomized subjects using the mock therapy unit and only generates warmth and does not emit LED-RL.
~All subjects will receive total of nine mock therapy procedures, three times per week for three consecutive weeks."
16035089|NCT02630290|Drug|Ropivacaine|Ultrasound-guided supraclavicular brachial plexus block with 0.5% ropivacaine
16035090|NCT02630290|Drug|Ropivacaine + Dexmedetomidine|Ultrasound-guided supraclavicular brachial plexus block with 0.5% ropivacaine plus low-dose (30 microg) dexmedetomidine
16035091|NCT02630277|Drug|Aflibercept|Intravitreal Aflibercept Injection 2.0 mg
16035092|NCT02630264|Drug|Endostatins|"Specification: 1mL/division, 1×1012 VP/1.0mL
~E10A preparation:
~Thaw frozen E10A stored at -20°C vials at room temperature until E10A is liquid.
~Swirl gently. Do NOT shake.
~Method of administration
~E10A was diluted with 0.9% sodium chloride to appropriate dose according to the longest diameter of the target lesion.
~After local anesthesia, we penetrated the syringe under normal skin subcutaneously 5 mm into the tumor or vertically into the lymph node under direct visualization and withdrew it to confirm the absence of blood.
~Applied local compression for 10 minutes and pasted a sterile sticker on the injection site to avoid bleeding."
16035093|NCT02630264|Drug|Paclitaxel injection|"Specification:
~30mg/5mL,
~Usage:
~160mg/m2 on day 3, according to instruction."
16035094|NCT02630264|Drug|Cisplatin injection|"Specification:
~20mg
~Usage:
~Cisplatin 25mg/ m2 on day 3, 4, and 5,according to instruction."
16035095|NCT02630251|Drug|GSK2820151|GSK2820151 is provided as capsules containing 1 mg, 5 mg, 10 mg, 50 mg, or 100 mg of GSK2820151 as free base equivalent to be administered orally. The dosing regimen is as follows: Week 1 - once daily on days 1, 3, 4, and 5; Week 2 - once daily on days 1, 2, 3, 4, 5; and Weeks 3 and beyond - once daily continuously.
16035096|NCT02630238|Dietary Supplement|Branched-Chain Amino Acid Supplementation|All participants will partake in the same diet & exercise regime but this group will also be placed on a BCAA intake level of 0.342g/kg of BCAA per day
16035097|NCT02630238|Other|Placebo|All participants will partake in the same diet & exercise regime but this group will receive an isocaloric placebo in form of carbohydrate solution
16035098|NCT02630238|Other|Exercise|Exercise will take place in a class based, circuit training setting run by a certified personal trainer composed of both aerobic and lifting exercises
16035099|NCT02630238|Other|Diet|Each participants will be placed on a daily energy deficit of 500 calories for the 8 week study period.
16035100|NCT02630225|Behavioral|Critical Time Intervention|"The Critical Time Intervention approach strengthens an individual's long-term ties to services, family and friends as well as provides emotional and practical support to individuals during the critical time of transition back to the community. CTI contains three phases:
~Phase 1 - The Support Specialist gets to know the individual, assesses the individual's need and implements a transition plan intended to link the individual to services and supports in the community.
~Phase 2 -- The Support Specialist monitors and adjusts the systems of support that were developed in Phase 1.
~Phase 3 -- The Support Specialist helps the individual develop and implement a plan to achieve long-term goals and finalizes the transfer of responsibilities to caregivers and community providers."
16035101|NCT02630225|Other|Treatment as Usual|"Services provided by HMC physicians and staff that are part of standard care for patients with firearm-related injuries. This care could include:
~All necessary medical care and scheduled follow-ups with subspecialty services
~Evaluation by social work with referral to appropriate community services
~Screening for alcohol use
~Discharge planning services
~Financial counseling"
16035102|NCT02630225|Behavioral|Motivational Interviewing|A brief intervention to elicit the goals and needs of participants. As needed, this will included referrals to community resources.
16035103|NCT02630225|Other|Multi-Agency Attention|Intervention cases will receive attention from a multidisciplinary team of professionals. This team will help the study Support Specialist identify service recommendations and provide case management guidance.
16035104|NCT02630199|Drug|AZD6738|The starting dose of 40 mg AZD6738 OD will be escalated to reach a maximum tolerated dose in patients with advanced solid malignancies, as defined by dose-limiting toxicity.
16035105|NCT02630199|Drug|Paclitaxel|Paclitaxel 80mg/m2 on days 1,8, and 15 every 4 weeks
16035106|NCT02630186|Drug|Rociletinib|A novel, potent, covalent (irreversible) small molecule, tyrosine kinase inhibitor (TKI) administered orally (PO) to patients with EGFRm NSCLC.
16035107|NCT02630186|Drug|MPDL3280A|A human IgG1 monoclonal antibody administered intravenously (IV)
16035108|NCT02630173|Procedure|Scaling and root planing|Scaling and root planing was done in both the groups
16035109|NCT02630173|Other|Endodontic treatment|In non vital teethRoot canal treatment was completed in two visits. 3% Naocle was used as irritant and calcium hydroxide was used as intracanal medicament .Obturation was done with gutta percha.
16035110|NCT02630160|Drug|Bupivacaine hydrochloride|Intraarticular infusion with bupivacaine
16035111|NCT02630160|Other|Physiological Saline|Intraarticular infusion physiological serum
16035112|NCT02630147|Other|Vanilla scent|"A 12-hour continuous recording for monitoring hemoglobin oxygen saturation, electrocardiogram and respiratory movements will be performed while the infant is exposed to vanilla scent (from vanilla solution on the infant's pyjamas).
~In addition, a 3-hour polysomnography will be done in a sub-sample on the morning following the night recording with vanilla solution."
16035113|NCT02630134|Other|These patients receive the Baeta device and take it home|
16035114|NCT02630121|Drug|Oxymetazoline Hydrochloride|Proportion of the subjects with 50% reduction in AHI.
16035115|NCT02630121|Drug|Placebo|Proportion of the subjects with 50% reduction in AHI.
16035116|NCT02630108|Procedure|Thermal Ablation|Thermal ablation in this trial includes radiofrequency ablation and microwave ablation, one of them can be chosen to be performed.
16035117|NCT02630108|Drug|EADM|EADM is a chemotherapy drug used in transarterial chemoembolization (TACE).Dosage: EADM 30-60 mg per patient,depending on the situation of the patient.
16035118|NCT02630108|Drug|Ultra-fluid lipiodol|Ultra-fluid lipiodol is a kind of embolization material used in TACE. Standard: 38% ultra-fluid lipiodol .
16035119|NCT02630108|Other|Gelatin sponge articles|Gelatin sponge articles embolization material used in TACE. Standard: 350-560 um in diameter.
16035120|NCT02630095|Drug|Nadroparin Calcium and Warfarin|Patients will take warfarin started at a dose of 2.5mg/d and with titration of dose to maintain a target INR of 2-3, and during the of perioperative period of Endoscopic treatment changing to use Nadroparin Calcium 4100IU／d，subcutaneous.
16035121|NCT02630095|Device|Doppler ultrasound and CT|all patient will take Doppler ultrasound examination every 3 months ；Abdominal CT will be done every 6 months。
16035122|NCT02630082|Procedure|Circumcision|
16035123|NCT02630082|Procedure|Flexible sigmoidoscopy|
16035124|NCT02630069|Drug|CDP-choline|CDP-choline 500mg once a day for 12 weeks
16035125|NCT02630069|Drug|Placebo|Placebo 500mg once a day for 12 weeks
16035126|NCT02630069|Behavioral|Supportive psychotherapy|Supportive psychotherapy 1 session/2 weeks for 12 weeks
16035127|NCT02630043|Drug|Tolcapone|Tolcapone is an oral agent that will be administered every day of each 21-day cycle during Cycle 1 and in combination with oxaliplatin during cycles 2-5 given IV on Day 1 of each 21-day cycle.
16035128|NCT02630043|Drug|Oxaliplatin|Oxaliplatin will be given starting in Cycle 2 at 100 mg/m2 IV on Day 1 of each 21-day cycle
16035129|NCT02630030|Drug|Ixazomib|Given PO
16035130|NCT02630017|Drug|ADHD methylphenidate first, placebo second|double-blind, counter-balanced administration
16035131|NCT02630017|Drug|ADHD placebo first, methylphenidate second|double-blind, counter-balanced administration
16035132|NCT02630017|Drug|Non-ADHD methylphenidate first, placebo second|double-blind, counter-balanced administration
16035133|NCT02630017|Drug|Non-ADHD placebo first, methylphenidate second|
16035134|NCT02630004|Drug|Melatonin oral gel 3%|
16035135|NCT02630004|Drug|Placebo oral gel|
16035136|NCT02629991|Drug|Intranasal Oxytocin (IN-OXT)|Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff).
16035137|NCT02629991|Other|Matched Placebo|Participants were instructed to take 16 IU/per day everyday (2 puffs per nostril, 4 IU each puff).
16035138|NCT02629978|Procedure|CT-guided percutaneous radiofrequency ablation|Percutaneous radiofrequency ablation (RFA) is a minimally invasive technique will be performed in patients with malignant pulmonary nodules in this group. RFA kills the tumors by causing coagulation necrosis via tissue heating. The electrode delivers thermal energy will be inserted into the target tissues under the CT guidance to ensure the area of ablation should cover the targets and the lung tissues 0.5-1.0 cm around the tumors. Post-operative scan and laboratory test will be conducted in time.
16035139|NCT02629965|Drug|tiotropium|fixed dose combination
16035140|NCT02629965|Drug|olodaterol|fixed dose combination
16035141|NCT02629965|Drug|tiotropium|
16035142|NCT02629952|Other|Blueberry Tea|Blueberry Tea
16035143|NCT02629939|Behavioral|course for learning CPR|
16035144|NCT02629926|Other|GH Replacement (NutropinAq®)|GH Replacement continued.
16035145|NCT02629926|Other|No additional treatment|GH Replacement not continued.
16035146|NCT02629913|Device|mementor somnium|
16035147|NCT02629913|Other|wait list|delayed access to mementor somnium
16035148|NCT02629900|Behavioral|Time restricted feeding|Participants will consume their daily calories only between 12:00 and 20:00 for 4 weeks
16035149|NCT02629887|Device|Non-inflatable supraglottic airway|at delivery if resuscitation is required infant randomized to NI-SGA or face mask as the interface for positive pressure ventilation.
16035150|NCT02629887|Device|Face Mask|at delivery - standard airway management per Neonatal Resuscitation Program utilizing face mask.
16035151|NCT02629887|Device|T-Piece Resuscitator|T-Piece Resuscitator for providing postivie pressure ventilation via face mask or non-inflatable supraglottic airway
16035152|NCT02629874|Drug|EA-230|at t=0 30, 90 or 180 mg/kg EA-230 will be administered intravenously over 2 hours.
16035153|NCT02629874|Drug|Endotoxin|at t=0 2ng/kg purified E.Coli endotoxin is administered intravenously
16035154|NCT02629874|Drug|Placebo|
16035155|NCT02629861|Drug|Fremanezumab|"Fremanezumab was provided as a sterile, unpreserved, aqueous solution for injection, 225 mg/1.5 mL pre-filled syringe for single-use administration.
~The 675 mg dose was given as 3 injections; doses of 225 mg were given as a single injection. Study drug was administered at the clinical site."
16035156|NCT02629861|Drug|Placebo|Placebo 1.5 mL pre-filled syringes identical in appearance to active intervention. Study drug was administered at the clinical site.
16035157|NCT02629848|Drug|Motesanib|Motesanib (AMG 706) 5 x 25 mg tablets
16035158|NCT02629848|Drug|Placebo|Motesanib placebo-matching tablets
16035159|NCT02629848|Drug|Paclitaxel|Paclitaxel IV
16035160|NCT02629848|Drug|Carboplatin|Carboplatin IV
16035161|NCT02629835|Other|intravenous 8 mg dexamethasone and perineural 0.8 ml of saline solution|
16035162|NCT02629835|Other|intravenous 0,8 ml of saline solution and perineural 8 mg of dexamethasone|
16035164|NCT02629809|Drug|Cyclophosphamide|Given IV
16035165|NCT02629809|Drug|Fludarabine Phosphate|Given IV
16035169|NCT02629783|Other|Psychomotor therapy|1 treatment of approximately 45 minutes the first 5 weeks after randomization. The treatment will focus on teaching the patients about body awareness and handling of there shoulder problems in daily living.
16035170|NCT02629783|Other|Physiotherapy|Patients are, in secondary care setting, given 3-5 basic physiotherapy exercises for there shoulder pain, targeting rotator cuff muscles and scapula thoracic muscles. Furthermore they are given advice on seeking further physiotherapy guidance in private setting.
16035171|NCT02629783|Drug|corticosteroid injection|At baseline, patients with signs of inflammation in the subacromial bursa, can receive a ultrasound guided corticosteroid injection in the bursa
16035172|NCT02629770|Drug|usual antibiotic treatment|pharmacological studies in patients treated with usual antibiotics, for different types of joint and bone infections
16035173|NCT02629757|Drug|β-elemene|β-elemene 600mg/d,ivdrip,d1-14,every 28 days for 1 cycle, totally 6 cycles
16035174|NCT02629744|Drug|Etrolizumab|Single SC dose of etrolizumab at 105 milligrams (mg) on Day 1.
16035175|NCT02629744|Device|Prefilled Auto-injector (Rotaject)|Participants self-administered etrolizumabSC injection using a prefilled auto-injector.
16035176|NCT02629731|Device|custom orthoses with varying degrees of hindfoot posting|The base orthotic design will be altered for one foot (most symptomatic in the case of patients or randomly chosen for controls) to give variations from 5-degree lateral hindfoot posting to 10-degree medial in 2.5-degree increments.
16035177|NCT02629718|Drug|NACT (Paclitaxel + Cisplatin or carboplatin)|Paclitaxel 150mg/m2 over 3 hours + Cisplatin 70mg/m2 or carboplatin AUC = 6, repeat per 21 days, 3 cycles.
16035178|NCT02629718|Procedure|radical surgery|Radical hysterectomy (Piver Type III or Type IV hysterectomy) plus bilateral pelvic lymph node dissection and para-aortic lymph node dissection or sampling
16035179|NCT02629705|Dietary Supplement|Carrageenan|Carrageenan 250 mg bid supplemented to a standard food
16035180|NCT02629705|Dietary Supplement|Placebo|Placebo (Mannitol/Aerosil) bid supplemented to a standard food
16035181|NCT02629692|Drug|Vodobatinib (K0706) capsules|"Part A: Vodobatinib (K0706) capsules in single ascending doses.
~Part B: Oral Vodobatinib (K0706) capsules in multiple ascending doses, once daily.
~Part C: Oral Vodobatinib (K0706) capsules at recommended phase 2 dose of 174 mg, once daily."
16035182|NCT02629679|Behavioral|Regular scholastic system and organized sports|This group will consist of children involved in regular school system who at the same time participate in organized sport in sport-clubs
16035183|NCT02629679|Behavioral|Regular scholastic system|The group will consist of children who are regularly in school, but not being involved in organized sport activities
16035184|NCT02629666|Behavioral|ERS and/or Self-management Strategies|
16035185|NCT02629653|Device|endovascular cooling (Zoll system)|The Zoll IVTM is an endovascular cooling system that consists of a control module (either CoolGard 3000 or Thermogard XP), a CoolGard start-up kit, and an ICY catheter (either IC-3585 AE or IC-3585).
16035186|NCT02629640|Other|Medical history questionnaire|Epidemiological review of past medical/dental history; residential history; occupational history; family history of neurodegenerative disease.
16035187|NCT02629640|Other|Clinical assessment and review|History of current illness; neurological examination including general appearance, full cognitive assessment and physical examination; MRI research brain scan.
16035188|NCT02629640|Other|Participant follow-up|Hospital patient management system; regular telephone contact with patient/representative.
16035189|NCT02629640|Other|Blood or buccal sample|Codon-129 genotyping; storage for future research.
16035190|NCT02629640|Other|Post mortem examination|Brain tissue donation to the Edinburgh Brain and Tissue Bank for research,including investigations for evidence of prion disease.
16035191|NCT02629627|Dietary Supplement|Conjugated linoleic acid/Leucine|Conjugated linoleic acid/Leucine capsules, 825mg time daily with the first bite of eat meal during 12 weeks.
16035192|NCT02629627|Drug|Metformin|Metformin in a dosis of 500mg per day (with the first bite of the second meal) during 12 weeks
16035193|NCT02629627|Dietary Supplement|Placebo of ACL/Leucine|Homologate placebo of ACL/Leucine (linseed oil capsules) in a dosis of 3600 mg each 24 hrs (2 capsules of 2400 mg with the first meal and 1200 mg or 1 capsule with the second meal) during 12 weeks.
16035194|NCT02629627|Other|Placebo of Metformin|homologate placebo of metformin (calcinated magnesia) in a dosis of 500 mg per day (with the first bite of the second meal) during 8 weeks
16035195|NCT02629614|Device|Cala ONE Device|The Cala ONE device is a wrist-worn stimulator which applies transcutaneous electrical stimulation non-invasively to the median and radial nerves of an individual through disposable hydrogel electrodes.
16035196|NCT02629601|Behavioral|Active Rewards|Vitality standard active rewards wellness program for physical activity promotion
16035197|NCT02629601|Behavioral|Lottery 1|Participants have 1 in 3 chance of winning 3 times the reward and 1 in 100 chance of winning 40 times the reward
16035198|NCT02629601|Behavioral|Lottery 2|Participants have 1 in 2 chance of winning 2 times the reward and 1 in 200 chance of winning 80 times the reward
16035199|NCT02629601|Behavioral|Broadcasting winners|Participants are told how many individuals won the lottery during that week.
16035200|NCT02629601|Behavioral|Active Rewards Doubled|Vitality standard active rewards wellness program for physical activity promotion with double the magnitude of incentives
16035201|NCT02629588|Behavioral|Multimodal or Unimodal Sensory stimulation|multimodal sensory stimulation, unimodal sensory stimulation, auditory stimulation, complex stimulation, median nerve stimulation.
16035202|NCT02629575|Device|stenting with the Coroflex ISAR sirolimus-eluting stent|coronary stenting
16035203|NCT02629562|Biological|B12019 and Neulasta|GCSF, Growth Colony Stimulating Factor
16035204|NCT02629549|Drug|OTL38|Infusion of OTL38 prior to surgery
16035205|NCT02629536|Drug|N-acetyl cysteine 600 mg, VitE 250 IU, VitC 500 mg tablet|N-acetyl cysteine 600 mg, VitE 250 IU, VitC 500 mg tablet
16035206|NCT02629523|Drug|Afatinib|Treatment efficacy of afatinib will be assessed in patients with lung cancer harboring EGFR mutations which were detected from circulating tumor DNA.
16035207|NCT02629510|Drug|Tachosil|
16035208|NCT02629497|Dietary Supplement|Primrose oil|T2DM patients and matched controls subjects will be given Primrose oil for 2 months, followed by 2-week washout. Blood will be drawn at the beginning, during, and following treatments and platelet function will be assessed.
16036424|NCT02621307|Dietary Supplement|Salba|
16035209|NCT02629497|Dietary Supplement|Fish Oil|T2DM patients and matched controls subjects will be given Fish oil for 2 months, followed by 2-week washout. Blood will be drawn at the beginning, during, and following treatments and platelet function will be assessed.
16035210|NCT02629484|Other|Focused cardiac ultrasound|focused cardiac ultrasound is a goal-focused transthoracic echocardiography examination of the heart, aimed to improve the diagnostic accuracy of clinical assessment
16035211|NCT02629471|Behavioral|response time due to light flash pulses|light flash pulses effect on response time to random targets appearance
16035212|NCT02629458|Procedure|Treatment by Surgical resection|
16035213|NCT02629458|Procedure|Stereotactic Ablative Radiotherapy (SABR)|
16035214|NCT02629445|Device|Cardiac Resynchronisation Defibrillator|Defibrillation testing of cardiac defibrilator
16035215|NCT02629419|Drug|Amphotericin B|Lipid crystal nano-particle formulation of amphotericin B
16035216|NCT02629406|Other|Hypoxia|Intermittent hypoxia which consist of five hypoxic periods (13% O2 inspired fraction of oxygen) each lasting 6 min, with five normoxic intervals of same duration
16035217|NCT02629393|Drug|ORGN001 (formerly ALXN1101)|
16035218|NCT02629380|Biological|hyaluronic acid|A single injection of 3 ml hyaluronic acid to be performed under arthroscopic view at the end of meniscectomy
16035219|NCT02629380|Procedure|meniscectomy alone|The patients randomized in this group will receive arthroscopic meniscectomy alone
16035220|NCT02629354|Drug|Ibuprofen|
16035221|NCT02629354|Drug|Caffeine|
16035222|NCT02629354|Drug|Ibuprofen|
16035223|NCT02629341|Dietary Supplement|Functional yogurt powder|"Once daily during 24 weeks, 150g of yogurt powder enriched with:
~Calcium (mg) 501 D3 Vitamin (Colecalciferol) (μg(UI)) 6(240) K Vitamin (μg) 80 C Vitamin (mg) 100 Zinc (mg) 10,39 Magnesium (mg) 250,5 L-Leucin (g) 1 Lactobacillus plantarum 3547 (ufc) 1x10e10"
16035224|NCT02629341|Dietary Supplement|Control yogurt powder|Once daily during 24 weeks, 150g of yogurt powder not enriched, isocaloric and with an equal macronutrient composition than the functional yogurt
16035225|NCT02629328|Device|CardioCel|Treatment with CardioCel implant
16035226|NCT02629315|Other|Carnoy's solution|
16035227|NCT02629315|Other|10% neutral buffered formaldehyde|
16035228|NCT02629302|Other|animal assisted therapy|physiotherapy, speech therapy and occupational therapy in the presence of an animal
16035229|NCT02629302|Other|standard therapy|standard physiotherapy, speech therapy and occupational therapy
16035230|NCT02629289|Drug|HSP-130|
16035231|NCT02629289|Drug|US-approved Neulasta|
16035232|NCT02629289|Drug|EU-approved Neulasta|
16035233|NCT02629276|Other|neurodynamic testing|
16035234|NCT02629263|Dietary Supplement|Viscous Fiber|Meta- analysis of Randomized Controlled Trials
16035235|NCT02629250|Procedure|SV maximization|When SpO2 ≥92%, mean arterial pressure (MAP) 65-100 mmHg, HR <100 bpm, Hb >8mg/dL and temperature ≥36℃, the patients will receive a 250 ml Ringer's lactate solution in 5 min as a fluid challenge for stroke volume (SV) maximization. The fluid challenge will repeat until the SV failed to increase by a factor of 10%. A reassessment on the SV maximization will be taken every 30 minutes and to restart algorithm when increased SV >10% or blood loss >250ml. Blood transfusions will be used to maintain a hemoglobin concentration over 8mg/dL.
16035236|NCT02629250|Procedure|supernormal DO2|Goal directed fluid therapy is administrated as group SV maximization. Then DO2I will be assessed. If at this stage the DO2I can not be greater than 600 mL/m2 (supernormal oxygen delivery goal), then dobutamine will be started at a dose of 2.5 μg/kg/min and increased by the same increment every 20 minutes until the described target is reached or until a maximal dose of 20 μg/kg/min is given. Dobutamine is decreased in dose or discontinued if the heart rate is above 100 beats per minute or shows signs of cardiac ischemia.
16035237|NCT02629237|Other|Multifaceted education|Subjects will be asked to watch a 5-10 min education film and participate in a 10-15 min counseling session with a trained doctor/nurse before glaucoma surgery,and at 1 week and 2 week after surgery.
16035238|NCT02629224|Drug|ASP8825|Oral
16035239|NCT02629211|Device|NaviAid™ AB|NaviAid™ AB Procedure
16035240|NCT02629159|Drug|Placebo for Adalimumab|Administered by subcutaneous injection once every other week
16035241|NCT02629159|Drug|Adalimumab|Administered by subcutaneous injection once every other week
16035242|NCT02629159|Drug|Placebo for Upadacitinib|Tablets taken orally once a day
16035243|NCT02629159|Drug|Upadacitinib|Tablets taken orally once a day
16035244|NCT02629146|Drug|Midazolam|
16035245|NCT02629146|Drug|Fentanyl|
16035246|NCT02629146|Drug|Isotonic saline|
16035247|NCT02629133|Behavioral|SHE Program|The SHE program is specifically tailored, innovative and relevant to diverse, racial, and ethnic sheltered, battered women in a number of ways including the images and content used in the intervention. It is also tailored to participants' alcohol or substance use status, and designed to reach participants across levels of motivation for change. The content of SHE is theory-driven, consistent with the motivational interviewing model of behavior, and consistent with the literature on effective interventions that address IPV and substance use.
16035337|NCT02628522|Other|20mL Lidocaine 2% and Epinephrine 1:100 000|Infiltration prior to liposuction
16035339|NCT02628496|Drug|Fluorescein injection, USP 10%|-2.5 ml intravenous 10 minutes before procedure
16035254|NCT02629094|Drug|Inspra /Eplerenone|Eplerenone is provided as 25- or 50-mg tablets that are to be taken orally. Subjects will be dosed at 25 mg daily for 1 week, and then 50 mg daily for 23 weeks. The total duration of dosing for each subject is 24 weeks.
16035255|NCT02629081|Other|Controls & Cases|All interventions are standard of care and both controls and cases will be treated the same. IEE results from controls and cases will be compared.
16035256|NCT02629068|Behavioral|PURPOSE|"The first week of the intervention will focus on welcoming everyone to the facebook group and laying down the ground rules for participation. Each additional week of the intervention will focus on a specific topic to promote discussion and learning of each particular skill; however, questions and discussions on other relevant topics are always welcome and encouraged.
~Week 1: Welcome Week Week 2: SUD Basics Week 3: Problem of Stigma Week 4: Communication Skills Week 5: Parental Monitoring Week 6: Stress Management Week 7: Family and Valued Directions Week 8: Putting It All Together"
16035257|NCT02629055|Other|Respiratory EMG|Titration of non-invasive ventilation on surface respiratory muscle activity
16035258|NCT02629042|Procedure|Partial endodontic treatment under local and/or locoregional anesthesia|The reference management consists in local and locoregional anesthesia of the molar and partial endodontic treatment. At the end of the emergency visit, all the patients, whatever their randomization group, will be given two types of antalgics and will be recommended to take them only if they have pain. Seventy-two hours after, all the patients, whatever their randomization will have endodontic treatment under local and locoregional anesthesia.
16035259|NCT02629042|Drug|prednisolone|The evaluated intervention consists in per-os administration of prednisolone (1 mg / kg) during the emergency visit followed-up by one morning dose by day during three days. At the end of the emergency visit, all the patients, whatever their randomization group, will be given two types of antalgics and will be recommended to take them only if they have pain. Seventy-two hours after, all the patients, whatever their randomization will have endodontic treatment under local and locoregional anesthesia.
16035260|NCT02629029|Procedure|Pre-op CTA with IV contrast|Preoperative mapping of perforators by computed tomography angiography (CTA) could prove valuable in head and neck free flap transfer and shorten the operation time significantly. This modality could provide useful information for H&N cancer reconstruction in difficult cases, especially in patients with large or through-and-through defects that might need multiple perforators in flap design. In addition, near-infrared (NIR) fluorescence imaging using indocyanine green (ICG) angiography can provide robust, intraoperative, objective data to optimize the free flap skin paddle design while potentially minimizing patient morbidity.
16035261|NCT02629029|Device|Computed tomography angiography (CTA)|
16035262|NCT02629016|Other|Mindfulness|
16035263|NCT02629016|Other|Wellness|
16035264|NCT02629003|Drug|[11C]Cimbi-36|
16035265|NCT02629003|Drug|[11C]Cimbi-36-5|
16035266|NCT02628990|Other|1.6 g plant stanols|Lipid-lowering effect of Yoghurt Drink with 1.6 g plant stanols
16035267|NCT02628990|Other|2 g plant stanols|Lipid-lowering effect of Yoghurt Drink with 2 g plant stanols
16035268|NCT02628990|Other|1.6 g plant stanols and camelina oil|Lipid-lowering effect of Yoghurt Drink with 1.6 g plant stanols and camelina oil
16035269|NCT02628990|Other|2 g plant stanols and camelina oil|Lipid-lowering effect of Yoghurt Drink with 2 g plant stanols and camelina oil
16035270|NCT02628990|Other|Placebo|Lipid-lowering effect of Placebo Yoghurt Drink
16035271|NCT02628977|Behavioral|Peer Based Sleep Health Education and Social Support|Participants randomly assigned to the intervention arm will receive Obstructive Sleep Apnea education and social support from a trained Peer Educator.
16035272|NCT02628977|Behavioral|Attention Control Group|Participants assigned to this arm of the study will receive standard sleep literature, providing information about OSA and access to available sleep services.
16035273|NCT02628964|Device|e-cigarettes|Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges.
16035274|NCT02628951|Drug|Ramucirumab|Ramucirumab injection for intravenous (I.V.) use, supplied in single-use 500-mg/50-mL vials containing 10 mg/mL of product in histidine buffer, administered as an I.V. infusion after dilution at 8 mg/kg every 2 weeks in the absence of disease progression, toxicity requiring cessation, or withdrawal for any other reason.
16035275|NCT02628951|Drug|Paclitaxel|Paclitaxel will be administered at a dose of 80 mg/m2 on Days 1, 8 and 15 of a 28-day cycle in the absence of disease progression, toxicity requiring cessation, or withdrawal for any other reason.
16035276|NCT02628938|Other|Miswak extract mouth wash|50% Miswak extract mouth wash (5ml) twice a day for 7 days
16035277|NCT02628938|Other|Miswak stick|Miswak stick twice a day for 7 days
16035278|NCT02628938|Other|Chlorohexidine gluconate|5 ml of 0.2% Chlorohexidine gluconate mouth wash Oraxine ® twice a day for 7 days
16035279|NCT02628925|Device|Nu-DESC DK|Nu-DESC DK as a screening tool is presented to the medical staff and they have to evaluate the tool an evaluate the screening tool on a evaluation form and rates on a 6 step Likert scale.
16035280|NCT02628912|Other|blood draw|
16035281|NCT02628912|Behavioral|study questionnaire|
16035282|NCT02628912|Other|cardiopulmonary exercise testing (CPET)|
16035283|NCT02628912|Other|DXA (dual-energy x-ray absorptiometry) scan|
16035284|NCT02628899|Device|Transfemoral TAVR|
16035285|NCT02628899|Device|SAVR|
16035286|NCT02628886|Biological|13-valent pneumococcal conjugate vaccine [Prevenar13®] plus tetanus toxoid|pregnant women will be given intramuscular PCV 13 vaccine between 28-34 weeks
16035287|NCT02628886|Biological|placebo 0.9% sodium chloride plus tetanus toxoid|pregnant women will be given intramuscular saline injection between 28-34 weeks
16035288|NCT02628886|Other|tetanus toxoid|new born babies will be given PCV13 vaccine at birth
16035289|NCT02628873|Device|HyCoSy|Saline infused sonogram in which air bubbles are delivered via the FemVue saline air device in order to evaluate the patency (openness) of the fallopian tubes
16035338|NCT02628509|Device|cardiac devices|patients receiving mechanical circulatory support or undergoing trans aortic valve replacement
16035290|NCT02628860|Drug|Ferinject (Ferric Carboxymaltose)|"Ferinject® to be administered as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg single administration) for body weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight <50 Kg .
~Study drug may be administered as IV drip infusion or IV undiluted bolus injection."
16035291|NCT02628847|Drug|sildenafil citrate|
16035292|NCT02628847|Drug|Placebo|
16035293|NCT02628834|Other|Fascial mobilization|The patient will lie on prone position with knee extension and therapist put the patient's plantar surface to her femoral region. Achilles, tibialis posterior, perenous longus and brevis distal tendons, gastrocnemius proximal tendons, hamstring's distal tendons will be mobilized at first stage. The second stage of fascia mobilization included the deep fascial mobilization of posterior crural muscle trunks. After that, the skin also will be gently mobilized. During fascial mobilization, once the spastic muscles relaxation will appeared, the ankle will move to dorsiflexion gradually. FM will carry out for 15 minutes for each foot.
16035294|NCT02628834|Other|Stretching Exercise|Patients will receive also stretching exercises consisted of 30 s stretching and 10 s resting periods and will carry out for 15 minutes for each foot at second day after the first evaluation.
16035295|NCT02628821|Other|Preterm Infants treated with non-invasive ventilation.|
16035296|NCT02628795|Behavioral|PRT + FM|Supervised progressive resistance training + functional mobility training (PRT+FM) 3 days per week for 16 weeks post-surgery.
16035297|NCT02628795|Other|Usual Care|Post-surgical usual care activities including any prescribed physical therapy
16035298|NCT02628782|Device|InSeal's Vascular Closure Device|Intravascular closure device
16035299|NCT02628769|Drug|Solithromycin|
16035300|NCT02628769|Drug|Placebo|
16035301|NCT02628756|Procedure|Endometrial injury|Office hysteroscopy (Karl Storz, Tuttlingen, Germany)
16035302|NCT02628743|Drug|Olesoxime|Participants will receive homogeneous suspension of olesoxime.
16035303|NCT02628730|Device|PVI using ThermoCool® SmartTouch® Catheter|PVI using RFA, using ThermoCool® SmartTouch® Catheter (Biosense Webster Inc., CA, US), guided by Ablation Index.
16035304|NCT02628730|Device|RFA ablation data comparison|Ablation data from previous ablations, using ThermoCool® SmartTouch® Catheter (Biosense Webster Inc., CA, US), that members of this group had in the past, will be compared with those of the Active Comparator Group.
16035305|NCT02628704|Drug|Selinexor|The fixed dose of selinexor is 60 mg (three 20 mg tablets)
16035306|NCT02628704|Drug|Placebo (for selinexor)|sugar tablet manufactured to mimic selinexor tablet
16035307|NCT02628704|Drug|carfilzomib|Administered as an IV infusion on Days 1, 2, 8, 9, 15 and 16 of each 4-week cycle for Cycles 1-13 and then on Days 1, 2, 15, and 16 for Cycles ≥ 14.
16035308|NCT02628704|Drug|Dexamethasone|Fixed oral dose of 20 mg will be given twice weekly (Days 1, 2, 8, 9, 15, 16, 22 and 23) in each cycle.
16035309|NCT02628691|Other|Liver fibrosis progression|A history taking and physical examination focused on hepatic disease and blood sampling for basic hematologic and hepatic function parameters will be performed. Patients will also be referred every year for ultrasound and transient elastography measurements and sampling for some additional liver function tests and measurement of HCV-RNA viral load.
16035310|NCT02628678|Dietary Supplement|FOS|
16035311|NCT02628665|Drug|photosensitizer(photofrin)|photosensitizer(photofrin): 2mg/kg
16035312|NCT02628665|Device|630 nm laser irradiation (DIOMED)|630 nm laser irradiation (DIOMED): The diseased tissue with laser irradiation in 1200 seconds.
16035313|NCT02628652|Dietary Supplement|GOS|
16035314|NCT02628652|Dietary Supplement|GLOS|
16035315|NCT02628652|Dietary Supplement|FOS|
16035316|NCT02628639|Device|high-density electroencephalography|
16035317|NCT02628626|Drug|Colesevelam|Patients who satisfy symptom criteria in Phase 2 will be randomized in a 1:1 ratio to receive either a combination of colesevelam (1.875 gm twice daily) and clonidine (0.1 mg oral twice daily) or an identical placebo for 4 weeks.
16035318|NCT02628626|Drug|Clonidine|Patients who satisfy symptom criteria in Phase 2 will be randomized in a 1:1 ratio to receive either a combination of colesevelam (1.875 gm twice daily) and clonidine (0.1 mg oral twice daily) or an identical placebo for 4 weeks.
16035319|NCT02628626|Other|Placebo|Placebo will be identical in appearance to the active drug.
16035320|NCT02628613|Drug|Vinorelbine plus Epirubicin|Evaluate the efficiency and safety of vinorelbine plus epirubicin as neoadjuvant chemotherapy in locally advanced HER2-negative breast cancer with TEKT4 variations
16035321|NCT02628613|Drug|Paclitaxel plus Epirubicin|standard neoadjuvant chemotherapy
16035322|NCT02628600|Drug|LAI 590 mg|LAI 590 mg QD: administered by inhaling drug product that had been aerosolized in an investigational eFlow nebulizer over approximately 14 minutes
16035323|NCT02628600|Drug|Multi-drug regimen|Multidrug antimycobacterial regimen from study INS-212
16035324|NCT02628587|Drug|Generic clopidogrel|"Comparison of different brands of clopidogrel:
~*Clopidogrel (generic) 300mg orally single dose on day 0. Later, clopidogrel 75mg orally single dose on days 1, 2 and 3."
16035325|NCT02628587|Drug|Patent clopidogrel|"Comparison of different brands of clopidogrel:
~*Clopidogrel (Plavix) 300mg orally single dose on day 0. Later, clopidogrel 75mg orally single dose on days 1, 2 and 3."
16035326|NCT02628574|Drug|TRX518 monotherapy|comparison of different (ascending) doses of TRX518 monotherapy
16035327|NCT02628574|Drug|TRX518 with gemcitabine|comparison of different (ascending) doses of TRX518 in combination with gemcitabine
16035328|NCT02628574|Drug|TRX518 with pembrolizumab|comparison of different (ascending) doses of TRX518 in combination with pembrolizumab
16035329|NCT02628574|Drug|TRX518 with nivolumab|comparison of different (ascending) doses of TRX518 in combination with nivolumab
16035330|NCT02628561|Device|Transcranial direct current stimulation|
16035331|NCT02628561|Behavioral|Constraint-Induced Movement Therapy|
16035332|NCT02628548|Behavioral|Cognitive training program|8 week cognitive training program
16035333|NCT02628535|Biological|MGD009|B7-H3 x CD3 DART protein
16035334|NCT02628522|Other|ADRCs therapy|Patients with chronic anal fissures will receive one treatment of local injections of fat enriched with adipose derived regenerative cells starting from December 2014.
16035335|NCT02628522|Device|Celution|Adipose derived regenerative cell isolation
16035336|NCT02628522|Device|Tulip cannulas|Lipoaspiration
16036425|NCT02621307|Dietary Supplement|Flax|
16035343|NCT02628483|Dietary Supplement|Fish Oil|1000mg fish oil per capsule (325mg EPA + 225mg DHA)
16035344|NCT02628483|Dietary Supplement|Fish Oil|1000mg fish oil per capsule (300mg EPA + 200mg DHA)
16035345|NCT02628470|Procedure|cervical manipulation|cervical high-velocity low-amplitude thrust manipulation
16035346|NCT02628470|Procedure|cervical control exercises|Exercises of flexion, extension and rotation of the cervical spine
16035347|NCT02628470|Procedure|Oscillatory mobilization technique|Joint mobilization technique type III according Maitland
16035348|NCT02628457|Procedure|arthroscopic rotator cuff repair|arthroscopic rotator cuff repair done in all patients to check whether, surgery itself changes the appearance of muscle atrophy in the supraspinatus in all patients irrespective of size of preoperative tendon retraction
16035349|NCT02628444|Biological|CYD Dengue Vaccine|0.5 mL, Subcutaneous
16035350|NCT02628444|Biological|Placebo (Sodium chloride 0.9%)|0.5 mL, Subcutaneous
16035351|NCT02628431|Device|Elfi tech monitor|
16035352|NCT02628418|Other|General Rehabilitation|All patients underwent basic rehabilitation following the guidelines according to the Bobath concept. Mobilization performed by physiotherapist of the lower and upper limbs through passive and/or active manoeuvres, gait training, standing and functional exercises and speech rehabilitation.
16035353|NCT02628418|Device|Specific hand rehabilitation by Gloreha device|"Each training session consisted of six parts:
~A sequence of digital joint flexion/extension exercises, from the thumb to the fifth finger (7 min);
~7 min of a number sequence (counting from one to five);
~A sequence of thumb-finger opposition movements from the 2nd to the 5th finger (7 min)
~A sequence of wave-like finger movements (7 min)
~A sequence of fist opening/closing (7 min)
~A sequence of flexion-extension of the fingers alternated with flexion-extension of the thumb (5 min)."
16035354|NCT02628418|Other|Specific hand rehabilitation performed by physiotherapist|"The activities were:
~Flexion-extension of the fingers (10 min);
~Thumb opposition with the other fingers keeping the forearm in supine position (10 min);
~Adduction and abduction of the fingers (10 min);
~Global movement of the hand consisting in reaching for a 0.5l bottle of water, taking hold of it, pouring water into a glass, and then putting the bottle down and letting go of it (10 min)."
16035355|NCT02628405|Drug|Carboplatin|Given IV
16035356|NCT02628405|Drug|Etoposide|Given IV
16035357|NCT02628405|Drug|Ifosfamide|Given IV
16035358|NCT02628405|Other|Laboratory Biomarker Analysis|Correlative studies
16035359|NCT02628405|Drug|Lenalidomide|Given PO
16035360|NCT02628405|Biological|Rituximab|Given IV
16035361|NCT02628392|Drug|DS-8500a|DS-8500a tablets 25mg, 50mg, 75mg
16035362|NCT02628392|Drug|Sitagliptin|capsules
16035363|NCT02628392|Drug|placebo|matching DS-8500a tablets and sitagliptin capsules
16035364|NCT02628366|Other|Personalized Dialysate Temperature|Dialysis centres randomized to the intervention will provide temperature-reduced personalized hemodialysis. A nurse will set the temperature of the dialysate to 0.5°C below each patient's body temperature measured just before starting the dialysis treatment. We are aware that some dialysis machines (e.g. Fresenius 5008) are only able to modify dialysate temperature by 0.5°C increments. For centres with those machines, the nurse will set the dialysate temperature 0.5 to 0.9 °C below each patient's body temperature (measured before starting the hemodialysis treatment) to a minimum of 35.5°C.
16035365|NCT02628353|Dietary Supplement|placebo|1 capsule of placebo product (100 mg carboxymetylcellulose) in one visit
16035366|NCT02628353|Dietary Supplement|phenolic compound|1 capsule of phenolic compound product (100mg phenolic compound + 100 mg carboxymetylcellulose) in one visit
16035367|NCT02628340|Other|Ex-vivo analysis|
16035368|NCT02628301|Dietary Supplement|Hypercaloric diet|Hypercaloric diet consisting of 60% excess calories based on resting energy expenditure (REE). Calories will be provided in the form of snacks in between the ad libitum meals. A subsequent hypocaloric diet will consist of 1.0x resting energy expenditure.
16035369|NCT02628301|Other|Normocaloric diet|Normocaloric diet
16035370|NCT02628288|Device|Coronary Bifurcation PCI|In one group, the coronary bifurcation lesion will be treated (Coronary bifurcation PCI) with the Axxess device + Absorb BVS. In the other group, the coronary bifurcation lesions will be treated(Coronary bifurcation PCI) by modified T stenting using Absorb BVS.
16035371|NCT02628275|Behavioral|Moderate to vigorous physical activity|55-90% maximum heart rate for 150min/week (current recommendations)
16035372|NCT02628275|Behavioral|Light physical activity|40-55% maximum heart rate for 150min/week
16035373|NCT02628262|Procedure|Vitrectomy with internal limiting membrane removal and gas tamponade|Vitrectomy with internal limiting membrane removal and gas tamponade
16035374|NCT02628249|Dietary Supplement|Base protein|0.8 g/kg/d of protein provided as crystalline amino acid modeled after egg protein
16035375|NCT02628249|Dietary Supplement|Sufficient protein|1.75 g/kg/d protein provided as crystalline amino acid modeled after egg protein.
16035376|NCT02628249|Dietary Supplement|Branched chain amino acids|Branched chain amino acids modeled after egg protein.
16035377|NCT02628249|Dietary Supplement|Essential amino acids|Essential amino acids modeled after egg protein.
16035378|NCT02628249|Dietary Supplement|Non essential amino acids|Non essential amino acids modeled after egg protein.
16035379|NCT02628236|Drug|Aminolevulinic Acid (ALA)|20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
16035380|NCT02628236|Device|BLU-U|10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
16035381|NCT02628223|Procedure|Selective Laser Trabeculoplasty|The procedure uses light energy provided by a neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp.
16035382|NCT02628223|Device|Neodymium:Yttrium Aluminum Garnet (YAG) laser|The procedure uses a 400 μm spot size of light energy provided by a low-energy, Q-switched, frequency-doubled (532 nm) neodymium (Nd):Yttrium Aluminum Garnet (YAG) laser with a short pulse duration of 3 nanoseconds that is directed into the iridocorneal angle via a goniolens viewed through a standard slit lamp.
16035383|NCT02628210|Other|map3® Cellular Allogeneic Bone Graft|Patients will receive map3® Cellular Allogeneic Bone Graft
16035384|NCT02628197|Dietary Supplement|calcium (500mg) and vitamin D (250I.U.)|calcium (500mg) and vitamin D (250I.U.) was given twice a day for 6 months
16035385|NCT02628197|Procedure|Scaling and root planing|scaling and root planing was done in the test group along with calcium (500mg) and vitamin D (250I.U.)
16035386|NCT02628184|Other|Maternity Services Development Programme|The Maternity Services Development Programme was implemented to improve care for local families (service users) involved with maternity services. The aim was to improve care during the early stages of a family's development and to establish foundations for long-term well-being. One aspect of the programme worked to improve the delivery of care by facilitating collaboration and joint-planning between service providers. The programme uses local city Children's Centres to co-locate services (different agencies or professionals who are working within the same locality). The aim of co-location was to promote stronger collaboration between maternity services and other service provider agencies to develop stronger partnerships, and to help identify those who are (or who may become) vulnerable.
16035387|NCT02628171|Other|Base Diet|Participants will receive a controlled diet with 0 g/d of cashew nuts. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet.
16035388|NCT02628171|Other|Base Diet with Cashew Nuts|Participants will receive a controlled diet with 42 g/d of cashew nuts. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet.
16035389|NCT02628158|Procedure|Vitrectomy with internal limiting membrane removal|Vitrectomy with removal of epiretinal membrane and internal limiting membrane
16035390|NCT02628145|Behavioral|Resistance Training Intervention|The RTI group will participate in a periodized RT program on 3 non-consecutive days/week using NSCA and ACSM guidelines and will be designed by a team member who is a NSCA certified strength and conditioning specialist. This program will consist of a full-body, nonlinear periodized program: a training method that has frequent variations in program variables. Intensity variations intensity are based on training phase. E.g., the first portion of 12-week cycle has more moderate and light days as participants adapt to the program. Weeks 1-4 will consist of primarily RT machine exercises and few unilateral and multi-joint light free weight exercise. Weeks 5-8 will incorporate more free-weight exercises that are multi-joint. Weeks 9-12 will incorporate more complex multi-joint movements.
16035391|NCT02628145|Behavioral|Active Control Group|The CON group will meet three times weekly for approximately 12 weeks for light physical activity and stretching.
16035392|NCT02628132|Drug|Paclitaxel|Paclitaxel will be given weekly for 6 cycles
16035393|NCT02628132|Drug|Durvalumab|Durvalumab will be given q2 wks concurrently with paclitaxel.
16035394|NCT02628119|Procedure|Intra-procedural access flow|"Intra-procedure access flow technique:
~Room temperature saline is injected into the vascular access blood stream during angioplasty via ReoCath(tm) 6 French antegrade or retrograde flow catheters. When the saline is injected into the access, an injection thermistor located close to the proximal end of the catheter records the temperature of the injected saline. A second thermistor located close to the distal tip of the catheter then records the thermodilution within the access and the HVT100 endovascular flow meter calculates and displays intragraft blood flow in ml/min."
16035395|NCT02628119|Procedure|Standard Angioplasty|Intervention based on 2 Dimensional fluoroscopy views
16035396|NCT02628106|Drug|Lipo-PGE1|all patients received 10 ug lipo-PGE1 intravenously once daily for consecutive 14 days
16035397|NCT02628093|Device|THUNDERBEAT|Tissue dissection and vessels ligation
16035398|NCT02628093|Device|LIGASURE|Tissue dissection and vessels ligation
16035399|NCT02628080|Drug|Atovaquone|Atovaquone has an EU marketing authorisation (held by Glaxo Wellcome UK Ltd) and is indicated for acute treatment of mild to moderate Pneumocystis pneumonia (PCP). It is also used in combination with proguanil for malaria prophylaxis.
16035402|NCT02628054|Biological|Typhoid Vaccine|Typhoid Vaccine injection given 7 days apart
16035403|NCT02628054|Biological|Placebo|Saline injection given 7 days apart
16035404|NCT02628041|Radiation|Permanent Iodine-125 seed implant|"Permanent Iodine seed implant is performed under general or epidural anesthesia with the patient is positioned in the lithotomy position.
~A Foley catheter is inserted in the bladder. Under transrectal ultrasound guidance, the prostates is scanned and the dosimetry is generated. Catheters are inserted in the prostate and the seeds are injected using the Nucletron automatic after loader according to the dosimetry plan.
~The catheters are removed at the end of the procedure."
16035405|NCT02628041|Radiation|High-Dose-rate Prostate Brachytherapy|"High-Dose-Rate Prostate brachytherapy is performed under general or epidural anesthesia, the patient is positioned in the lithotomy position.
~A Foley catheter is inserted in the bladder. Under transrectal ultrasound guidance, catheters are inserted in the prostate to assure adequate coverage. The patient is returned in dorsal decubitus and a CT scan or Ultrasound scan is performed. A inverse-planning dosimetry plan is generated to deliver 19 Gy to the target volume. The patient is treated and then the implant is removed and anesthesia is reversed."
16035406|NCT02628028|Drug|LY3337641|Administered orally
16035407|NCT02628028|Drug|Placebo|Administered orally
16035408|NCT02628002|Device|Antigravity treadmill (Alter-G)|Test arm subjects will exercise according to the Bruce protocol unweighted to 75% of their body weight with additional unweighting to 50% during the test if unable to reach target at 75% weight. Once these subjects have reached their target heart rate on the Bruce protocol, patients will receive the Tc-99m injection as per standard clinical protocol and maintain target heart rate for 1 minute following the injection.
16035409|NCT02628002|Device|Conventional treadmill/regadenoson|Subjects randomized to the control arm will proceed with the clinical standard regadenoson pharmacological stress SPECT study with adjunctive low-intensity walk on conventional treadmill during regadenoson and Tc-99m injections if tolerated. If they are unable to tolerate any treadmill exercise, they will receive regadenoson and Tc-99m injections at rest. Study patients will have stable systemic blood pressure with readings equal to or greater than 90 mmHg systolic. Other inclusion and exclusion criteria are described in detail below.
16035410|NCT02627989|Drug|Diflucortolone valerate (Nerisona)|Potency Class II (classified as Very Strong class in Japan) topical corticosteroids
16035411|NCT02627989|Drug|Diflucortolone valerate (Texmeten)|Potency Class II (classified as Very Strong class in Japan) topical corticosteroids
16035412|NCT02627976|Device|Compression vest, Thuasne|Wearing a compression 4 days/weel with a minumum of 6 hours per day
16035413|NCT02627963|Drug|tivozanib hydrochloride|tivozanib hydrochloride
16035414|NCT02627963|Drug|Sorafenib|Sorafenib
16035415|NCT02627950|Drug|Morphinhydrochloricum|5 mg morphine intravenously
16035418|NCT02627950|Drug|Isotonic sodium chloride|10 ml NaCl 0.9% intravenously
16035419|NCT02627911|Device|Diabeloop System|Insulin delivery
16035420|NCT02627911|Device|Continuous Glucose Monitoring|
16035421|NCT02627911|Device|Accelerometer and heart rate monitor|Monitoring and measurement of physical activity
16035422|NCT02627911|Dietary Supplement|Meals|Calibrated meals for all patients and outstanding dinners for patients being in outstanding meals situation (Centers : Grenoble, Toulouse, Montpellier)
16035423|NCT02627898|Drug|green tea extract|Green tea extract capsules, 400mg 1 time daily with the first bite of eat meal
16035424|NCT02627898|Drug|placebo|Placebo capsules, 400mg 1 time daily with the first bite of eat meal
16035425|NCT02627885|Behavioral|Internet-based CBT|Through the use of CBT material at an Internet-platform, we aim for behavioral changes in the subjects to improve everyday level of functioning and quality of life.
16035426|NCT02627885|Other|SMT|Standard Medical Treatment includes pharmacological management and other typical medical interventions for the patient group but no behavioural interventions
16035427|NCT02627859|Device|Durolane SJ|1ml single intra-articular injection in ankle
16035428|NCT02627846|Device|EVLA|1% Lidocaine with 1:200,000 epinephrine will be used for skin infiltration. The EVLA fibre is introduced into the vein using the Seldinger technique and its tip will be positioned under duplex ultrasound (DUS). Then tumescent anaesthetic, made of a solution of 100ml of 1% Lidocaine with 1:200,000 epinephrine in 900ml of 0.9% Sodium Chloride and buffered to pH 7.4 with 10ml of 8.4% Sodium Bicarbonate, will be infiltrated around the target axial vein under DUS using a spinal needle and a peristaltic pump. Following deployment of appropriate laser safety precautions, the laser energy will be delivered via the fibre. The wavelength used is 1470nm, with NeverTouch Gold-Tip fibre, at 10W power. This laser light energy is converted into heat inducing a permanent, non-thrombotic occlusion.
16035429|NCT02627846|Device|ClariVein®|1% Lidocaine with 1:200,000 epinephrine will be used for skin infiltration. MOCA is performed by a device called ClariVein® (Vascular Insights, UK) which is a long thin catheter that is passed up inside the vein, with a rotating wire that protrudes at an angle from the end when deployed. This is motorised via an electric motor in the handle and rotates at approximately 3500 revolutions per minute. In addition, liquid sclerotherapy is injected at the handle end by a syringe. This sclerotherapy liquid emerges from the end of the catheter and is present in the area of the rotating tip. The sclerosant will be Sodium Tetradecyl Sulphate (STS), marketed as Fibrovein. Concentration of 1.5% Fibrovein will be used, and maximum of 12ml.
16035430|NCT02627846|Drug|Lidocaine with 1:200,000 epinephrine solution|It is used as local anaesthetic given via subcutaneous injection, so that the skin is numb prior to the introduction of either endovenous laser ablation or mechenochemical ablation catheter. Typically 1-2ml is required.
16035431|NCT02627846|Drug|Lidocaine with 1:200,000 epinephrine solution|100ml of 1% lidocaine with 1:200,000 epinephrine is diluted into 900ml of 0.9% Sodium Chloride to make the tumescent anaesthetic solution, which is required when using endovenous laser ablation.
16035432|NCT02627846|Drug|Sodium Bicarbonate|10ml of 8.4% Sodium Bicarbonate is added into the tumescent anaesthetic solution, to buffer the pH to 7.4. Tumescent anaesthetic solution is required when using endovenous laser ablation.
16035433|NCT02627846|Drug|Sodium Tetradecyl Sulphate|1.5% of Sodium Tetradecyl Sulphate, marketed as Fibrovein, will be used with the mechanochemical ablation device (ClariVein®). This is a sclerosing agent with Manufacturer Authorisation, and it will be used unmodified. Intravenous injection causes intima inflammation and thrombus formation. This usually occludes the injected vein.
16035434|NCT02627833|Other|observation|Record lung function, Lung clearance index, inflammatory status
16035435|NCT02627820|Drug|Isis 420915/GSK 299872|Open label study in comparison to historic control.
16035436|NCT02627807|Radiation|IMRT using individualized CTV|Intensity modulated radiotherapy (IMRT) using individualized CTV based on disease extension risk atlas and computer-aided delineation is given as 2.13 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 70.29 Gy to the primary tumor.
16035437|NCT02627807|Radiation|IMRT using traditional CTV|Intensity modulated radiotherapy(IMRT) using traditional CTV is given as 2.13 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 70.29 Gy to the primary tumor.
16035438|NCT02627807|Drug|Gemcitabine and cisplatin (induction chemotherapy)|Induction chemotherapy is optional for patients with T2-4N0-3M0 NPC. Patients who participate in another randomized trial (NCT01872962) at the same time receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before radiotherapy.
16035439|NCT02627807|Drug|Docetaxel and cisplatin (induction chemotherapy)|Induction chemotherapy is optional for patients with T2-4N0-3M0 NPC. Patients who haven't participated in other trials receive docetaxel (75 mg/m² d1) and cisplatin (75mg/m²,total dose average to d1-d3) every 3 weeks for 3 cycles before radiotherapy.
16035440|NCT02627807|Drug|Cisplatin 100mg/m² concurrent chemotherapy|Cisplatin concurrent chemotherapy is required for patients with T2-4N0-3M0 NPC. Patients who participate another clinical trial (NCT01872962) at the same time receive cisplatin (100mg/m² d1) every 3 weeks for 3 cycles concurrently with radiotherapy.
16035441|NCT02627807|Drug|Cisplatin 80mg/m² concurrent chemotherapy|Cisplatin concurrent chemotherapy is required for patients with T2-4N0-3M0 NPC.Patients who haven't participated in other trials receive cisplatin (80mg/m²,total dose average to d1-d3) every 3 weeks for 3 cycles concurrently with radiotherapy.
16035442|NCT02627794|Device|Restora™ Steroid eluting spacer|The Restora™ Steroid eluting spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery.
16035443|NCT02627794|Device|Silastic Silicone Spacer|The Silastic Silicone Spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6-8 days following surgery.
16035444|NCT02627768|Drug|No Intervention|Participants who have a confirmed diagnosis of Psoriatic Arthritis (PsA) and are starting ustekinumab or a tumor necrosis factor alpha inhibitor (TNFi) as a first, second, or third line of biological disease-modifying antirheumatic drugs (bDMARD) therapy will be observed.
16035445|NCT02627755|Device|aScope®|we use the aScope® as a flexible and dirigible guide to facilitate the passage of the endotracheal tube through the vocal cords.
16035446|NCT02627755|Device|Glidescope®|use of Glidescope® in conventional manner to facilitate endotracheal intubation
16035912|NCT02624869|Biological|evolocumab (AMG 145)|Administered by subcutaneous injection
16035447|NCT02627742|Device|MetaNeb® System|The treatment protocol used for Respiratory Care during the CHANGE IN PRACTICE period of the Study will be that prescribed by the patient's health care team in the routine standard care of each patient. With the exception of standard airway clearance and lung expansion procedures, other components of the patients respiratory care regimen will remain the same as during the standard therapy period, however the CHANGE IN PRACTICE will incorporate the use/treatment with The MetaNeb® System as an alternative to usual airway clearance and lung expansion procedures. Use of The MetaNeb® System will follow the labeling of the device.
16035448|NCT02627729|Device|Linear cutter-Circular stapler|a 5 to 6 cm-long colonic pouch will be created with a 80 mm linear cutting-closing stapler. The anastomosis of j-pouch will be routinely strengthened with 3:0 vicryl sutures. Then, a pouch to anal anastomosis will be performed
16035449|NCT02627729|Device|Circular stapler|a 5 to 6 cm-long colonic segment will be left at the distal part and a side-to-end anastomosis will be performed.
16035450|NCT02627716|Procedure|SOS Plan|"It is a customised procedure that involves a meeting (crisis planning meeting) with the patient, their various medical and social referrers and any other person who they may have desired to invite.
~The booklet outlines four avenues to consider:
~Contact details / contact person
~Treatment and current follow-ups
~Medical care in the event of a crisis
~Practical aid in the event of a crisis
~Updating the SOS Plan every 6 months in the absence of hospitalisation or after each relapse that leads to an unscheduled psychiatric hospitalisation lasting more than two weeks."
16035451|NCT02627703|Other|Oncotype DX|The Oncotype DX® assay is a multi-gene reverse-transcriptase-polymerase-chain-reaction (RT-PCR) test that analyzes the expression of 21 genes, and quantifies the 10 year distant breast cancer recurrence risk in patients with stage I and II, lymph node negative, estrogen receptor positive disease who plan to be treated with tamoxifen for 5 years.
16035452|NCT02627690|Other|islet transplanted|islet transplantation
16035453|NCT02627690|Other|non islet transplanted|no islet transplantation (for a non nephrologic reason)
16035454|NCT02627677|Drug|ponatinib 30 mg QD|ponatinib 30 mg, taken orally once daily
16035455|NCT02627677|Drug|ponatinib 15 mg QD|ponatinib 15 mg, taken orally once daily
16035456|NCT02627677|Drug|nilotinib 400 mg BID|nilotinib 400 mg, taken orally twice daily
16035457|NCT02627664|Other|observational study|natural history of non dopaminergic signs
16035458|NCT02627651|Other|cognitive and motor assignments|walking on treadmill, performing cognitive assignment; and performing the cognitive assignment while walking .
16035459|NCT02627638|Other|Ostheopathic treatment|Once their clinical data were collected and their symptoms were assessed, all the enrolled patients had an osteopathic session a week during two weeks. After those sessions, they had an interview (scheduled between D11 and D14) with a psychologist
16035460|NCT02627625|Drug|Tiotropium|4 inhalations
16035461|NCT02627612|Behavioral|Pro Vetus|Volunteer mentors (a mix of Veterans and non-Veterans) in the civilian community work with transitioning Veterans for approximately four months within five transition domains (1. Employment/Education, 2. Housing, 3. Family and Legal, 4. Social/Community/ Physical Fitness and 5. Medical Care).
16035462|NCT02627612|Behavioral|Team Red, White, and Blue (TM RWB)|TM RWB is a 501(c)(3) non-profit, Veteran support organization found in 2010. Its mission is to enrich the lives of America's Veterans by connecting them to their community through physical and social activity. Central to TM RWB's mission is that inspiring Veterans to become physically active will create opportunities to establish authentic connections to other Veterans, active duty military, and civilians as well as improve the chances for continued successful integration. Enrollment in TM RWB takes place by simply signing up online and providing a name, email address, and zip code (teamrwb.org). TM RWB is not designed as a mental health intervention.
16035463|NCT02627599|Device|Breath Responsive Variable Bolus Oxygen Conserving Device|Mini Electronic Oxygen Conserving Device
16035464|NCT02627586|Other|HIIT|High-intensity interval training (HIIT) is performed on a cycle ergometer. It consists of a 10 min warm-up followed by 4 min intervals in Zone III (at 90-95% of peak heart rate), with each interval separated by 3 min of active pauses in zone I (at 50-60% of peak heart rate). The total duration of the HIIT training is 38 min.
16035465|NCT02627586|Other|MICE|MICE is also performed on a cycle ergometer at an intensity of 50-80% of peak VO2 or 60-75% of peak heart rate for 47 min (in order for the two training protocols to be isocaloric). The control group will perform MICE training three times per week.
16035466|NCT02627573|Procedure|Unrelated allogeneic stem cell transplantation|
16035467|NCT02627573|Drug|Busulfan|
16035468|NCT02627573|Drug|Fludarabine monophosphate|
16035469|NCT02627573|Drug|Tacrolimus|
16035470|NCT02627573|Drug|Mycophenolate mofetil|
16035471|NCT02627573|Drug|Cyclophosphamide|
16035472|NCT02627573|Drug|Thymoglobulin|
16035473|NCT02627560|Drug|Tranexamic Acid|moisten the surgical wound surface with 20 ml tranexamic acid 25 mg/ml
16035474|NCT02627560|Drug|saline|moisten the surgical wound surface with 20 ml placebo (0.9% saline)
16035475|NCT02627547|Behavioral|Normal training|5-10 hours of endurance training each week
16035476|NCT02627547|Behavioral|De-training|No training
16035477|NCT02627534|Procedure|Ultrasonic debridement|All periodontal pockets received ultrasonic debridement (Cavitron, Dentsply) with specific inserts (UI25KSF10S, Hu-Friedy). All diseased sites were instrumented in one session by an experienced periodontist.
16035478|NCT02627534|Procedure|Antimicrobial photodynamic therapy|After ultrasonic debridement, one randomly selected periodontal pocket received an additional aPDT performed by a trained operator (NMRBA). One pocket with probing depth ≥ 5mm in each patient was randomly selected to aPDT. After washing the pocket with saline solution, the photosensitizer (methylene blue 10mg/ml) was applied to the bottom of the pocket in a coronal direction. Following this, the pocket was exposed to a diode laser light with a fibre optic application for 1 min (Thera Lase DMC - Brazil), with wavelength of 660nm, power of 60mW and fluency of 129J/cm2.
16035479|NCT02627521|Procedure|PRU guided CABG|Coronary Artery Bypass Surgery
16035480|NCT02627521|Procedure|CABG per standard of care|Coronary Artery Bypass Surgery
16035481|NCT02627521|Device|VerifyNow assay|Platelet reactivity Units by VerifyNow assay
16035482|NCT02627521|Drug|Ticagrelor|Ticagrelor administration prior to randomization
16035483|NCT02627508|Drug|Pregnenolone|orally administered Pregnenolone capsules
16035484|NCT02627508|Drug|Placebo|orally administered placebo capsules
16035485|NCT02627495|Device|transcranial Direct Current Stimulation (tDCS): (Soterix ©)|Subjects will undergo tDCS stimulation. We will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated limb (or for bilateral amputees contralateral to the most painful side). The subject will undergo stimulation for 20 minutes. The subject will have 5 sessions of stimulation during a 1 week time period.
16035486|NCT02627482|Device|Fetal heart rate monitor (Monica AN24)|"The AN24 is a portable, battery powered device, developed in the UK and designed to monitor passively an unborn baby in the antenatal period. The device is CE marked and is attached via a cable assembly which in turn attaches to five standard disposable electrodes placed on the abdomen of a pregnant woman. It is intended for ambulatory use in either the home or hospital environment.
~The AN24 has had rigorous checks in the UK and has been used in many European countries. No hazards have been identified that could compromise the safety of, or cause harm to the fetus or the mother. The only potential issue identified is a local reaction under the electrodes. Nonetheless, the electrodes used are the standard disposable ECG electrodes, used routinely for adult ECG measurements."
16035487|NCT02627469|Behavioral|Extended professional oral hygiene care|Weekly professional oral hygiene performed by dental hygienists
16035488|NCT02627469|Device|Electric toothbrush (Oral-B Professional Care 7000)|Weekly professional oral hygiene performed by dental hygienists
16035489|NCT02627469|Device|1100 ppm sodium fluoride dentifrice (Zendium Classic)|Weekly professional oral hygiene performed by dental hygienists
16035490|NCT02627456|Biological|PfSPZ Vaccine|PfSPZ Vaccine contains aseptic, purified, vialed, cryopreserved, radiation attenuated NF54 P. falciparum sporozoites. PfSPZ Vaccine will be delivered by DVI in the pilot and main phases of the study. Participants will receive either 1 or 3 injections.
16035491|NCT02627456|Biological|PfSPZ Challenge Material|PfSPZ Challenge are aseptic, cryopreserved P. falciparum sporozoites used for CHMI trials. PfSPZ Challenge is not radiated, thus it is fully infections. It will be administered via DVI to participants in Arm 1c and 1d.
16035492|NCT02627456|Drug|PBS and HSA Diluent|The diluent for PfSPZ Vaccine and Challenge is composed of phosphate-buffered saline (PBS) and human serum albumin (HSA). Vials of sterile PBS (1.6ml) and HSA (0.5ml) will be shipped to the clinical site, where diluent composed of PBS and HSA is prepared. HSA is a licensed product which is approved for parenteral, IV administration to humans. The HSA lots are extensively tested to ensure that it is free of infectious agents as listed in the CoA and is approved for use by the Food and Drug Administration(FDA).
16035493|NCT02627456|Other|Normal Saline|Sterile isotonic (0.9%) normal saline will be procured in the US and shipped to Mali at ambient temperature. Like the product, normal saline is a clear liquid, making it indistinguishable from the study product when drawn up into a syringe.
16035494|NCT02627456|Drug|Coartem|Artemether/lumefantrine (coartem) is a licensed antimalarial in the US and Mali for use for uncomplicated malaria. It has an excellent safety profile and is widely used to treat malaria. Artemether /lumefantrine is a Category C pregnancy drug. Thus all female participants will undergo pregnancy testing prior to receiving this drug.
16035495|NCT02627456|Drug|ASAQ|"ASAQ is a fixed dose artemisinin based combination therapy that is indicated and approved for the management of uncomplicated P. falciparum malaria. It has been shown to be as effective as artemether
~/lumefantrine when taken at a once/day dosage."
16035496|NCT02627443|Drug|Berzosertib|Given IV
16035497|NCT02627443|Drug|Carboplatin|Given IV
16035498|NCT02627443|Drug|Gemcitabine Hydrochloride|Given IV
16035499|NCT02627443|Other|Laboratory Biomarker Analysis|Correlative studies
16035500|NCT02627443|Other|Pharmacological Study|Correlative studies
16035501|NCT02627430|Drug|Hsp90 Inhibitor AT13387|Given IV
16035502|NCT02627430|Other|Laboratory Biomarker Analysis|Correlative studies
16035503|NCT02627430|Other|Pharmacological Study|Correlative studies
16035504|NCT02627430|Drug|Talazoparib|Given PO
16035505|NCT02627417|Drug|Dapsone (Disulone®)|Experimental group will receive dapsone at a fixed dose of 100 mg per day for a total of 12 months unless they fail to respond to the treatment.
16035506|NCT02627417|Drug|"Prednisone (Cortancyl®) alone followed by monitoring and standard of care"|Patients randomized in the control arm will be treated only prednisone at a daily dose of 1 mg per kg for 2 weeks and then tapered and stopped over a week for a total of 3 consecutive weeks. After this 3 weeks period, patients from arm B will be left without treatment and monitored.
16035507|NCT02627417|Drug|Prednisone (Cortancyl®)|Experimental group will receive prednisone at a daily dose of 1 mg per kg for 2 weeks and then tapered and stopped over a week for a total of 3 consecutive weeks.
16035508|NCT02627404|Other|Blood sample|A blood sample is taken at inclusion of patients in the study to perform DNA analysis
16035509|NCT02627404|Device|actometer|To evaluate the quality of sleep, questionnaires are completed and patients wear an actometer for 21 days. They will also complete a sleep diary
16035510|NCT02627391|Other|Early surgical aortic valve replacement|
16035511|NCT02627391|Other|Delayed Surgical aortic valve replacement|
16035512|NCT02627378|Other|Extracorporeal Membrane Oxygenation|Patients received veno-venous Extracorporeal Membrane Oxygenation (ECMO) support
16035513|NCT02627378|Other|Non Extracorporeal Membrane Oxygenation|Patients received no Extracorporeal Membrane Oxygenation (ECMO) support
16035514|NCT02627365|Behavioral|Individualized, interactive short messaging intervention|An Individualized, interactive short messaging intervention reminding study participants to take antiretroviral medication and report any problems.
16035515|NCT02627352|Procedure|Micropulse Transscleral Cyclophotocoagulation|In mTSCPC, a diode laser is used to damage tissue of the ciliary body, the tissue inside the eye that produces aqueous, the clear fluid in the eye that maintains intraocular pressure. This causes it to produce less aqueous.
16035516|NCT02627326|Procedure|open flap debridement|periodontal surgery in the form of open flap debridement was done in both the groups
16035517|NCT02627313|Device|GammaPod Tumour Bed Boost|Single fraction Tumour Bed boost of 8Gy in 1 Fraction
16035518|NCT02627287|Device|FlexPen®|For subcutaneously (s.c. under the skin) injection.
16035519|NCT02627287|Device|DV3316 pen-injector|For subcutaneously (s.c. under the skin) injection.
16035520|NCT02627287|Drug|placebo|For subcutaneously (s.c. under the skin) injection
16035521|NCT02627274|Drug|RO6874281|RO6874281 will be administered as per the schedule specified under arm description.
16036426|NCT02621307|Dietary Supplement|Control|
16035522|NCT02627274|Drug|Trastuzumab|Trastuzumab will be administered as per the schedule specified under arm description.
16035523|NCT02627274|Drug|Cetuximab|Cetuximab will be administered as per the schedule specified under arm description.
16035524|NCT02627261|Biological|blood samples and bone marrow aspirates will be collected|Serial analysis will be performed at different time point in order to evaluate the presence or absence of residual disease after different treatment steps (before treatment, after induction, after intensification, after consolidation)
16035525|NCT02627248|Drug|Huaier Granule|20g tid, orally
16035526|NCT02627248|Drug|Epirubicin|70 mg/m² ivdrip, d1 for both TEC and ET regimes
16035527|NCT02627248|Drug|Docetaxel|75 mg/m² ivdrip, d2 for both TEC and ET regimes
16035528|NCT02627248|Drug|Cyclophosphamide|600 mg/m² ivdrip, d2 for TEC regimes
16035529|NCT02627235|Behavioral|DIAL|The physical activity intervention is based on Social Cognitive Theory and includes feedback on physical activity progress via IVR system and monthly graphic-based feedback letters delivered in the mail. Messages will encourage incremental increases until national PA guidelines are reached and provide specific information on cancer risk reduction.
16035530|NCT02627235|Behavioral|Wait List Control|Access to DIAL intervention 12 weeks following baseline assessment.
16035531|NCT02627222|Other|Pro-vitamin A biofortified cassava|Pro-vitamin A biofortified cassava is the product of international conventional breeding programs (non-GMO) in order to increase the pro-vitamin A content of cassava for improved nutritional intake
16035532|NCT02627222|Other|White cassava|Conventional white cassava
16035533|NCT02627209|Other|spectrophotometric assay|measurement of enzyme activity in the serum
16035534|NCT02627209|Other|radial immunodiffusion|measurement of the precipitated ring diameters showing enzyme activity in the serum
16035535|NCT02627196|Device|BAROSTIM NEO® System|
16035536|NCT02627196|Drug|Medical Management|
16035537|NCT02627183|Procedure|Catheter ablation|Subjects undergoing catheter ablation for the first time for atrial fibrillation as part of their regular care (regardless of involvement in this study).
16035538|NCT02627183|Behavioral|Exercise training|Subjects participating in supervised exercise classes for up to 60 minutes in length 2 times/week as part of their involvement in another study (NCT02602457).
16035539|NCT02627170|Device|dynamic Scheimpflug analyzer (corneal visualization Scheimpflug technology [Corvis ST], OCULUS, Wetzlar, Germany)|
16035540|NCT02627157|Device|Dynamic Scheimpflug Analyzer|Measurements of Corneal Biomechanical Properties Using a Dynamic Scheimpflug Analyzer
16035541|NCT02627144|Drug|Bevacizumab|Bevacizumab will be administered at the recommended dose of 10 mg/kg of body weight once every 2 weeks as an intravenous infusion until disease progression.
16035542|NCT02627144|Drug|Interferon alpha-2a|Interferon alpha-2a will be administered at the recommended starting dose of 9 MIU 3 times a week until disease progression.
16035543|NCT02627131|Biological|Autologous Bone Marrow Mononuclear Cells|Transplantation of Autologous Bone Marrow Mononuclear Cells
16035544|NCT02627118|Device|FRESENIUS 160NR|2 MONTHS OF DIALYSIS WITH THE FRESENIUS 160NR DIALYZER
16035545|NCT02627118|Device|NIPRO ELISIO-15H|2 MONTHS OF DIALYSIS WITH THE NIPRO ELISIO-15H DIALYZER
16035546|NCT02627105|Behavioral|Beef group|Subjects in the beef group will be asked to consume 4 or more servings of beef per week (and to avoid all other red meats) during the 6 month study.
16035547|NCT02627105|Behavioral|Non-beef group|Subjects in the non-beef group will be asked to avoid all red meats during the 6 month study.
16035548|NCT02627092|Other|Copper linen exposure|Subjects will use hospital linens (top sheet, bottom sheet, pillow case, gown) made with copper to see if this helps reduce infections during their hospital stay.
16035549|NCT02627079|Other|Daily SMS text messaging|
16035550|NCT02627066|Behavioral|Volume Control|Persistent reduction in post-dialysis weight and dietary sodium restriction
16035551|NCT02627066|Behavioral|Volume Control + Exercise|Volume reduction intervention and comprehensive exercise counseling
16035552|NCT02627053|Drug|rivaroxaban|
16035553|NCT02627040|Device|InterTan Intertrochanteric Nail|Cephalomedullary fixation of intertrochanteric fracture with an InterTan Intertrochanteric Nail
16035554|NCT02627040|Device|Gamma 3 Intertrochanteric Nail|Cephalomedullary fixation of intertrochanteric fracture with an Gamma 3 Intertrochanteric Nail
16035555|NCT02627027|Drug|Duvie Tab. 0.5mg, Glucodaun OR Tab. 750mg|oral administration
16035556|NCT02627027|Drug|CKD-395 0.25/750mg|oral administration
16035557|NCT02627014|Other|Manual therapy|"6 treatments: 2 treatments for week
~1 treatment = 30 minutes"
16035558|NCT02627014|Other|Home physical therapy|once a day: 15 minutes
16035559|NCT02627014|Other|Manual therapy in cervical region|"6 treatments: 2 treatments for week
~1 treatment = 30 minutes"
16035560|NCT02627014|Other|Home physical therapy in cervical region|once a day: 15 minutes
16035561|NCT02627001|Device|NuMask Intraoral Airway Device|NuMask Intraoral Airway Device
16035562|NCT02627001|Device|Bag Valve Mask|Conventional bag valve mask
16035563|NCT02626988|Behavioral|Promotion of a biodiverse diet|Nutrition education combined with Agriculture Capacity building focused on a key set of nutritious crops. Component (C) 1 - Participatory Identification of Intervention Approach (PIIA); C2 - Local stakeholder consultation; C3 - Sensitisation of community; C4 - Formation of Diversity club. Club will receive capacity building from a Village health worker. The following topics will be covered species selected for promotion: 1. Where to locally source inputs and expected price, 2. How/when to prepare plots using organic inputs, 3. Planting and best-practice management practices, 4. Seed saving and storage and 4. Active Cooking demonstrations and Nutrition Education and counselling including Diversified cooking practices
16035564|NCT02626962|Drug|ipilimumab|Ipilimumab every 3 weeks for a total of four doses (Cycles 1 and 2)
16035565|NCT02626962|Drug|Nivolumab|Nivolumab every 3 weeks for a total of four doses (Cycles 1 and 2) followed by Nivolumab every 2 weeks
16035597|NCT02626611|Drug|Food Flour Buildup|Food flours identified as allergic (based on food challenge), will be introduced at week 8. The food dose will be escalated every 2 weeks up to 2000 milligrams of each of the food flours. Subjects are required to reach 300 milligrams at week 16 to continue to week 30. Subjects must tolerate 2000 milligrams per food by week 28 in order to be randomized.
16036047|NCT02623972|Drug|Cyclophosphamide|administered IV with adriamycin for 4 cycles
16035566|NCT02626949|Behavioral|MBSR Course|Formal mindfulness meditation methods taught in the MBSR course include: Body Scan Meditation (a supine meditation), Gentle Hatha Yoga (practiced with mindful awareness of the body), Sitting Meditation (mindfulness of breath, body, feelings, thoughts, and emotions), and Walking Meditation. Informal Mindfulness Meditation Practices (mindfulness in everyday life) include: 1) awareness of pleasant and unpleasant events, and, 2) deliberate awareness of routine activities and events such as eating, weather, walking, and interpersonal communication. Daily home assignments include a minimum of 30 minutes daily formal mindfulness practices and 5-15 minutes informal practice, 6 days per week for the entire duration of the course. Course sessions will consist of discussions oriented around weekly homework assignments, including an exploration of obstacles, and development of self-regulatory skills and capacities.
16035567|NCT02626949|Behavioral|HEP Course|HEP is an active control that matches MBSR in non-specific factors, such as the amount of time participants interact, but does not include mindfulness practice as an active component. HEP instructors will be selected from experts in the areas covered: music, nutrition education, and, functional movement. The study's RC will coordinate HEP sessions and monitor attendance. Following the 8-week HEP protocol, subjects will meet monthly in 1.5-hour educational sessions to match the booster sessions of MBSR participants.
16035568|NCT02626936|Other|Dual-hormone closed-loop|Interventions will be undertaken one to 5 days after sensor insertion. Subjects will be admitted at the research center at 7:00 am. Subject's pump will be substituted with the study pump and an additional pump containing glucagon will be installed. At 7:00, CLS will be initiated. At 9:00, a standardized breakfast (75g CHO) will be served. Study subjects will consume the same meal on the two intervention days. During the intervention, patients will be allowed to do sedentary activities. Patients will allowed to consume caffeine during the intervention, but will have to replicate their caffeine consumption on both interventions.The intervention day will end at 13:00.
16035569|NCT02626936|Drug|Insulin|Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)
16035570|NCT02626936|Drug|Glucagon|Glucagon (Eli Lilly) will be used during dual-hormone closed-loop strategy.
16035571|NCT02626936|Device|Dexcom G4 Platinum glucose sensor|
16035572|NCT02626936|Device|Accu Chek Combo insulin pump|
16035573|NCT02626897|Device|GENEActiv Original Accelerometer|Wrist-worn device measuring accelerations as a measure of daily activity.
16035574|NCT02626897|Device|ActiGraph GT3X Accelerometer|Wrist-worn device measuring accelerations as a measure of daily activity.
16035575|NCT02626884|Drug|Ibrutinib|
16035576|NCT02626858|Device|extra treatment planning CT-scan|Beside the standard post-operative CT-scan, an extra pre-operative CT-scan is performed.
16035577|NCT02626845|Drug|Rituximab|Standard of care induction with Rituximab: 375mg/m2 weekly x 4 weeks. Once randomized, the rituximab dose will be 1000mg IV every 4 months x 2.
16035578|NCT02626845|Other|Placebo|Will be given at two time-points (week 16 and week 32) to subjects in the Placebo Arm.
16035579|NCT02626832|Other|Procedural|All subjects receive intravenous hypertonic saline and serial blood samples are drawn for AVP concentrations
16035580|NCT02626819|Behavioral|MOVE! Toward Your Goals|Patients will take an online tool accessing weight management and lifestyle behaviors, and will meet with a health coach regularly to establish SMART goals to help them in their weight loss journey. The goals may be supported by the patients' PACT members
16035581|NCT02626819|Behavioral|Enhanced Usual Care|"Patients will be given information on healthy living messages that were created by the VA, and given more information on specific messages they are interested in from the health coaches, but will not receive official coaching. These messages are the current standard of care at the VA for obesity counseling."
16035582|NCT02626780|Device|GID SVF-2|Comparison of the number of hairs before and after treatment of autologous adipose-derived SVF as a percentage increase or decrease in growth.
16035583|NCT02626767|Other|Novel high-intensity interval exercise training|Please see information already included in the 'intervention' arm description.
16035584|NCT02626754|Drug|Sunitinib malate|Sunitinib 50mg will be given for 2 consecutive weeks then followed by one week of rest.
16035585|NCT02626741|Dietary Supplement|meal replacement group|The participants will receive SlimWell 60 grams per meal for 2 meals per day plus life style modification including educational sessions of exercise, dietary intake, food record. The duration is 3 months.
16035586|NCT02626741|Behavioral|control group|The participants will receive only life style modification including educational sessions of exercise, dietary intake, food record. The duration is 3 months.
16035587|NCT02626728|Procedure|laparoscopic assisted transanal surgery (TAMIS)|all patients included recieve laparoscopic assisted transanal minimally invasive surgery
16035588|NCT02626715|Drug|Reduced-Intensity Conditioning Regimen|Campath (alemtuzumab) - drug class: monoclonal antibody Droxia (hydroxyurea) - drug class: antimetabolite Fludara (fludarabine) - drug class: antimetabolite Alkeran (melphalan) - drug class: alkylating agent Thiotepa (triethylenethiophosphoramide) - drug class: cytotoxic agent
16035589|NCT02626715|Drug|Myeloablative Conditioning Regimen|Campath (alemtuzumab) - drug class: monoclonal antibody Thiotepa (triethylenethiophosphoramide) - drug class: cytotoxic agent Fludara (fludarabine) - drug class: antimetabolite Busulfex (busulfan) - drug class: alkylating agent
16035590|NCT02626702|Other|Observational|Excess blood from subjects will be analyzed to explore the relationship between Immune Modulators and IVF outcomes.
16035591|NCT02626689|Other|Quality of Life (QOL) questionnaires|Monitoring of FACT-AN, SF-36V2, TransQol, and NTD PRO assessments,
16035592|NCT02626689|Other|Healthcare Resource Utilization|Monitoring and reviewing HealthCare Resource Utilization information.
16035593|NCT02626676|Other|Educational Programme|Educational Programme consists of lectures and group dynamics about nutrition during hemodialysis sessions.
16035594|NCT02626650|Other|Symptom elicitiation|Survey procedure, people check or uncheck symptoms they have or haven't experienced. We randomly assign participants to only one of these symptom elicitation procedures.
16035595|NCT02626637|Other|Physical activity coaching|Children and adolescents will receive the study intervention, which includes exercise coaching and prescription, that is be incorporated into the standard care they receive from the nurse practitioners during their outpatient visits.
16035596|NCT02626611|Drug|Omalizumab|Omalizumab is an anti-Immunoglobulin E antibody injection and will be administered per product insert from weeks 0 through 16 of the study.
16035598|NCT02626598|Device|Blended Belotero|Belotero blended with 0.1 cc of 1% lidocaine with epinephrine per 1.0 cc Belotero will be injected to etched in fine facial lines
16035599|NCT02626585|Procedure|Postrhinoplasty taping|Postrhinoplasty taping is commonly applied by rhinoplasty surgeons. Following rhinoplasty the nose is generally taped and a (thermoplastic) nasal cast is applied on top of this to make sure the final form of the nose is protected. Postoperatively, this cast is removed at some point. After this, some of the surgeons prefer to tape the nose with nasal tapes such as Micropore (3M) etc. Postrhinoplasty taping is the term used for this. The nose is (generally) taped horizontally with 1/2 inch wide tapes. This is done superiorly from radix to inferiorly to nasal tip. The idea is to compress the nose and to cover it. The duration of postrhinoplasty taping differs according to the preference of the surgeon and the patient
16035600|NCT02626572|Drug|S47445 5mg|S47445 5 mg tablets taken orally once a day during breakfast, starting the day after inclusion visit and ending the day of the W024 visit (main period) or starting the day after inclusion visit and ending the day of the W052 visit (period including main period and optional extension period).
16035601|NCT02626572|Drug|S47445 15mg|S47445 15 mg tablets taken orally once a day during breakfast, starting the day after inclusion visit and ending the day of the W024 visit (main period) or starting the day after inclusion visit and ending the day of the W052 visit (period including main period and optional extension period).
16035602|NCT02626572|Drug|S47445 50mg|S47445 50 mg tablets taken orally once a day during breakfast, starting the day after inclusion visit and ending the day of the W024 visit (main period) or starting the day after inclusion visit and ending the day of the W052 visit (period including main period and optional extension period).
16035603|NCT02626572|Drug|Placebo|Placebo tablets taken orally once a day during breakfast, starting the day after inclusion visit and ending the day of the W024 visit (main period) or starting the day after inclusion visit and ending the day of the W052 visit (period including main period and optional extension period).
16035604|NCT02626559|Drug|liposomal bupivacaine/plain bupivacaine peri-articular injection|Injection of a mixture of liposomal and plain bupivacaine around the knee during total knee arthroplasty.
16035605|NCT02626546|Procedure|Major surgical procedure|observation of postoperative outcomes
16035606|NCT02626533|Procedure|Total Knee Arthroplasty|Patients will undergo total unilateral knee arthroplasty for osteoarthritis.
16035607|NCT02626520|Drug|Gemcitabine and nanoparticle albumin bound paclitaxel|Gemcitabine and nab-paclitaxel given every 14 days x 4 cycles
16035608|NCT02626520|Drug|5-fluorouracil and irinotecan|FOLFIRI.3 given every 14 days x 4 cycles
16035609|NCT02626520|Radiation|Preoperative chemoradiation|Pre-operative chemoradiation to 40 Gy in 20 fractions
16035610|NCT02626520|Procedure|Definitive resection|Definitive surgical resection of primary tumor
16035611|NCT02626507|Drug|Gedatolisib|adenosine triphosphate (ATP) competitive, highly selective and potent inhibitor of pan-class I isoform phosphatidylinositol-4,5-bisphosphate 3-kinase (PI3-K)
16035612|NCT02626507|Drug|Faslodex|Faslodex® (Fulvestrant) is a potent anti-estrogen drug that binds and degrades estrogen receptors (ERs).
16035613|NCT02626507|Drug|Palbociclib|Palbociclib (Ibrance®) is an orally active highly selective reversible inhibitor of cyclin-dependent kinase (CDK) 4 and CDK 6.
16035614|NCT02626507|Drug|Zoladex|Zoladex is used to render menopause in pre-menopausal subjects, given once every 28 days starting at least 14 days prior to treatment.
16035615|NCT02626494|Drug|N-Acetylcystein|n-AC will be given according to a double-blind, placebo-controlled cross-over design. Subjects receive 3 doses of n-AC over 2 consecutive days (total dose=4800mg; individual doses=2x1200mg, 1x2400mg). Subjects will take 2 first doses (à 1200mg) of n-AC 5 days after the screening assessment (one in the morning, one in the evening), and the last dose (2400mg) 1h prior to scanning, with 12 hours dosing intervals in between. Preparation and blinding of n-AC capsules will be performed by the Kantonsapotheke Zürich according to the guidelines of Good Manufacturing Practice.
16035616|NCT02626494|Drug|Placebo|14 days before or after, placebo will be administered analogously as described with n-AC. Placebo will be given according to a double-blind, placebo-controlled cross-over design. Subjects receive 3 doses of placebo over 2 consecutive days (total dose=4800mg; individual doses=2x1200mg, 1x2400mg). Subjects will take 2 first doses (à 1200mg) of placebo 1 day before scanning (one in the morning, one in the evening), and the last dose (2400mg) 1h prior to scanning, with 12 hours dosing intervals in between. Preparation and blinding of placebo capsules will be performed by the Kantonsapotheke Zürich according to the guidelines of Good Manufacturing Practice.
16035617|NCT02626481|Drug|Daratumumab|patients treated with Daratumumab (16 mg/kg) and Dexamethasone (40 or 20 mg regarding age of patient)
16035618|NCT02626481|Drug|Dexamethasone|patients treated with Dexamethasone (40 or 20 mg regarding age of patient)
16035619|NCT02626455|Drug|Copanlisib (BAY80-6946)|"Copanlisib is supplied as lyophilized preparation in a 6 mL injection vial. The total amount of copanlisib per vial is 60 mg. The solution for IV infusions is obtained after reconstitution with normal saline solution. For patients on R-B dosing of copanlisib will be administered on Days 1, 8 and 15 of each 28-day cycle. Copanlisib will be administered and then rituximab followed by bendamustine. For patients on R-CHOP dosing of copanlisib will be administered on Days 1 and 8 of each 21-day cycle. Treatment with copanlisib/placebo will be continued up to 12 months.
~Copanlisib will be administered before rituximab followed by cyclophosphamide, doxorubicin and vincristine infusions. Prednisone/prednisolone tablets to be taken for 5 days."
16035620|NCT02626455|Drug|Placebo|Placebo is supplied as lyophilized preparation in a 6 mL injection vial. The developed placebo lyophilisate is equivalent to the 60 mg copanlisib formulation, with regard to the composition of excipients and the instructions for reconstitution and dose preparation. Placebo dosing will be administered as per copanlisib described above. Applies to the phase III part of the study only.
16035621|NCT02626455|Drug|Rituximab|Rituximab is administered as an infusion at a dose of 375 mg/m2 body surface on Day 1 of each 28-day cycle for patients assigned to R-B and on Day 2 of each 21-day cycle for patients assigned to R-CHOP.
16035622|NCT02626455|Drug|Cyclophosphamide|Cyclophosphamide is administered as an infusion at a dose of 750 mg/m2 body surface on Day 2 of each 21-day cycle for patients assigned to R-CHOP
16035623|NCT02626455|Drug|Doxorubicin|Doxorubicin is administered as an infusion at a dose of 50 mg/m2 body surface on Day 2 of each 21-day cycle for patients assigned to R-CHOP
16036090|NCT02623686|Other|Aroma Therapy Massage and Inhalation Patch|
16035624|NCT02626455|Drug|Vincristine|Vincristine is administered as an infusion at a dose of 1.4 mg/m2 body surface (maximum dose 2.0 mg) on Day 2 of each 21-day cycle for patients assigned to R-CHOP
16035625|NCT02626455|Drug|Bendamustine|Bendamustine is administered as an infusion at a dose of 90 mg/m2 body surface on Day 1 and Day 2 for patients assigned to R-B
16035626|NCT02626455|Drug|Prednisone|Prednisone is given as 100 mg tablets daily from Day 2 to Day 6 for patients assigned to R-CHOP
16035627|NCT02626442|Other|Exercise|6 month group exercise class
16035628|NCT02626429|Dietary Supplement|Amino acid intake|Amino acid intakes will be varied at 0.2-2.6 g/kg/day
16035629|NCT02626416|Device|LenZOC (mobile application)|The transparency of the visual axial at the anterior segment is observed through a dilated pupil. Image of the eye of a patient taken with LenZOC is calibrated with a standardized white and black bar adhered to the patient's eyelid. Calibrated images are dimmed as graysalegrayscale. The intensity and progress of visual axial opacification (VAO) is quantified as absolute area and relative area (calculated as: absolute area of VAO/ absolute area of dilated pupil).
16035630|NCT02626403|Device|Anodal tDCS|Patients will receive anodal tDCS during 20 minutes preceded and followed by a behavioral assessment (Coma Recovery Scale Revised) and an EEG. The anodes will be placed over F3, F4, CP5, and CP6 in order to stimulation the fronto-parietal cortex bilaterally.
16035631|NCT02626403|Device|Sham tDCS|Identical to anodal tDCS, except that the stimulation will be stopped after 15 seconds.
16035632|NCT02626390|Other|Frequent instructions/feedback and an Internal Focus of Attention|
16035633|NCT02626390|Other|Minimal instructions/feedback and an External Focus of Attention|
16035634|NCT02626377|Behavioral|Support provided by social worker|Caregivers randomized in intervention arm will receive an information booklet (which informs about existing structures and actions) and will receive support provided by a social worker schedule every 6 months during two years. The support duration will be one hour and will be defined as two parts: administration of the LASA questionnaire, and a standardized semi directive interview to assess needs.
16035635|NCT02626377|Other|Information booklet receipt|Caregivers will only receive an information booklet (which informs about existing structures and actions)
16035636|NCT02626364|Drug|crenolanib|single-agent crenolanib at 100 mg PO TID
16035637|NCT02626351|Other|Quality Improvement|In a stepped wedge fashion all 7 PHC clinics will receive QI one by one (exception: the two smallest clinics will be rolled into one step). Each step is of 2 months' duration. The study will commence with baseline data collection across all clinics, before the first randomised clinic receives the QI intervention. The QI intervention involves the following activities at each clinic: [1] Situational Analysis: assessment of clinic needs and gaps in processes that influence the specified study endpoints; [2] Intensive Intervention Phase (2 months): the clinic QI team (healthcare facility staff) with support of CRH QI mentors maps clinic processes and establishes priorities for process improvements through identification of bottlenecks, root-causes and commence plan-do-study-act (PDSA) cycles; [3] Maintenance Phase (duration varies for each clinic based on stepped wedge study design): clinic processes are further improved through iterative PDSA cycles; [4] Follow up.
16035638|NCT02626351|Other|Baseline data collection (active comparator)|Endpoint data collection only
16035639|NCT02626338|Drug|Crenolanib|
16035640|NCT02626338|Drug|Mitoxantrone|
16035641|NCT02626338|Drug|Cytarabine|
16035642|NCT02626338|Drug|Etoposide|
16035643|NCT02626338|Drug|Fludarabine|
16035644|NCT02626338|Drug|G-CSF|
16035645|NCT02626338|Drug|Idarubicin|
16035646|NCT02626325|Other|High-carbohydrate or High-monounsaturated fat diets|
16035647|NCT02626312|Other|Laboratory Biomarker Analysis|Correlative studies
16035648|NCT02626312|Procedure|Magnetic Resonance Imaging|Correlative studies
16035649|NCT02626312|Radiation|Radiation Therapy|Undergo radiation therapy
16035650|NCT02626312|Other|Survey Administration|Ancillary studies
16035651|NCT02626299|Drug|Docosahexaenoic acid - 800mg/day|All participants will take 1000 mg/DHA per day (1 capsule will be labeled with 200 mg; 2 capsules will be masked with 400 mg each)
16035652|NCT02626299|Drug|Docosahexaenoic acid - 200mg/day|The control group will receive 1-capsule containing 200 mg DHA/d.
16035653|NCT02626299|Other|Placebo|Participants will receive 2 capsules (masked) containing half soybean oil and half corn oil equaling 800 mg.The soybean and corn oil combination does not contain DHA.
16035654|NCT02626286|Other|HIV quarterly global care|
16035655|NCT02626273|Radiation|weight loss|
16035656|NCT02626260|Other|adhesive strip|Adhesive strip with a standard adhesive base
16035657|NCT02626247|Dietary Supplement|Vitamin A +Long chain PUFA|3 capsules per day, two capsules at breakfast and one capsule at lunch, with a glass of water.
16035658|NCT02626247|Other|Placebo|3 capsules per day, two capsules at breakfast and one capsule at lunch, with a glass of water.
16035659|NCT02626234|Drug|INC280|
16035660|NCT02626234|Drug|digoxin|
16035661|NCT02626234|Drug|rosuvastatin|
16035662|NCT02626221|Other|Non Interventional Study|Non Interventional Study
16035663|NCT02626208|Device|Nestorone®/Estradiol Contraceptive Vaginal Ring|Three arms of contraceptive vaginal rings contain a fixed dose (200 mcg/day) of Nestorone® and escalating doses (75 µg/d, 100 µg/d, or 200 µg/d /day) of estradiol
16035664|NCT02626195|Dietary Supplement|nutritional support program|"Nutritional support program is briefly described below.
~Interval: 5-10 days Contents: admission is required
~Calories: 30-35Kg, via enteral or parenteral
~Protein: 1.2-1.5g/Kg
~Lipid : 1-1.5g/Kg
~Mineral and vitamins supply
~Blood glucose control
~Daily monitoring by dietician and specialized nurse"
16035665|NCT02626182|Drug|sildenafil|active sildenafil
16035666|NCT02626182|Drug|placebo|sugar pill that looks like sildenafil tablets
16035667|NCT02626169|Drug|Clopidogrel|Clopidogrel 75 mg once a day by mouth for 30 days
16035668|NCT02626169|Drug|Ticagrelor|Ticagrelor 90 mg twice daily by mouth for 30 days
16035703|NCT02625909|Drug|SOF/VEL for 6 weeks|Open-label SOF/VEL 400mg/100mg once daily to be given to participants randomised to Arm A (6 weeks short treatment duration).
16035704|NCT02625909|Drug|SOF/VEL for 12 weeks|Open-label SOF/VEL 400mg/100mg once daily to be given to participants randomised to Arm B (12 weeks standard treatment duration).
16036132|NCT02623309|Procedure|Allogeneic (Allo) hematopoietic stem cell transplantation|
16035669|NCT02626156|Device|Cooling gel pack|Individuals will self monitor skin temperature of skin over a recently health venous leg or diabetic foot ulcer with a dermal thermometer. A cooling gel pack will be applied to skin of recently healed venous leg or diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increases and stays elevated 2°F above the usual temperature of that site, the individual will cool the skin 5 consecutive days and will continue to monitor skin temperature.
16035670|NCT02626156|Device|Cooling cotton pack|Individuals will self monitor skin temperature of skin over a recently health venous leg or diabetic foot ulcer with a dermal thermometer. A cotton filled pack will be applied to skin of recently healed venous leg or diabetic foot ulcers for 30 minutes 3 times a week for six months. If the temperature of this skin site increases and stays elevated 2°F above the usual temperature of that site, the individual will cool the skin 5 consecutive days and will continue to monitor skin temperature.
16035671|NCT02626143|Other|Investigational nutrient-rich whey protein formula|
16035672|NCT02626143|Other|Cow's milk based formula|
16035673|NCT02626130|Procedure|Cryosurgery|Undergo cryoablation
16035674|NCT02626130|Other|Laboratory Biomarker Analysis|Correlative studies
16035675|NCT02626130|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16035676|NCT02626130|Biological|Tremelimumab|Given IV
16035677|NCT02626117|Device|LASER deepithelialization|the selected participants were assigned in test and control. Under LA full thickness flap was reflected until the mucogingival junction and recipient area was prepared. The connective tissue graft harvested from palate was placed on the root surface and secured with 5-0 absorbable sutures. Diode (GaAlAs) laser with a wavelength of 820 nm and a power of 1.5 watt in a continuous mode was applied to remove the sulcular epithelium. The connective tissue graft was placed on the root surface at the level of the CEJ and then secured with 5-0 absorbable sutures in both test and control sites using sling suture..
16035678|NCT02626117|Device|Sham LASER deepithelialization|the selected participants were assigned in test and control. Under LA full thickness flap was reflected until the mucogingival junction and recipient area was prepared. The connective tissue graft harvested from palate was placed on the root surface and secured with 5-0 absorbable sutures. sham LASER deepithelialisation was applied to the sulcular epithelium. The connective tissue graft was placed on the root surface at the level of the CEJ and then secured with 5-0 absorbable sutures in both test and control sites using sling suture..
16035679|NCT02626104|Dietary Supplement|Bovine lactoferrin|The children will be randomly assigned to receive 100 mg of bovine lactoferrin twice a day orally for the whole period of antibiotic therapy.
16035680|NCT02626104|Dietary Supplement|Maltodextrin|The children will be randomly assigned to receive 100 mg of placebo - maltodextrin twice a day orally for the whole period of antibiotic therapy.
16035681|NCT02626091|Procedure|Left-sided colonic resection|"During interventions, anastomosis perfusion will be estimated (outcomes: visual appreciation of the surgeon, ICG fluorescence-based enhanced reality and series of peri-operative samplings) in order to validate the accuracy of ICG fluorescence-based enhanced reality technique.
~In any case, the resection will be performed according to the surgeon's appreciation."
16035682|NCT02626078|Other|observation and interview of residents|Residents will be observed during lunch to evaluate their behavior, verbal interactions between residents. The food intake during 24 hours will be evaluated also. In an interview after lunch, the appreciation of the meal by residents will be assessed by a questionnaire and the score of the nutritional state will be defined.
16035683|NCT02626065|Biological|blood sampling|Blood samples (44mL) will be taken before starting treatment with Nivolumab and at week 2, week 12, week 54 or at relapse (before week 54)
16035684|NCT02626065|Drug|Nivolumab|injection of Nivolumab every two weeks from day 0 and until relapse, toxicity motivating withdrawal or temporary suspension of treatment or up to 54 weeks.
16035685|NCT02626052|Behavioral|Dizziness Handicap Inventory|A standardized questionnaire used to quantify symptoms of dizziness.
16035686|NCT02626052|Behavioral|Global Rating of Change|A standardized questionnaire used to review the overall outcome of the participants condition with physical therapy.
16035687|NCT02626052|Behavioral|Patient Acceptable Symptom State|A standardized questionnaire used to determine whether meaningful progress has been made
16035688|NCT02626052|Procedure|Spontaneous Nystagmus Test|An observational test procedure used to identify involuntary eye movements caused by inner ear and/or brain dysfunction. The test is performed both in room light and with fixation blocked with a Micromedical Technologies infrared lens.
16035689|NCT02626052|Procedure|Gazehold Nystagmus Test|An observational test procedure used to identify involuntary eye movements caused by inner ear and/or brain dysfunction. The test is performed both in room light and with fixation blocked with a Micromedical Technologies infrared lens.
16035690|NCT02626052|Procedure|Primary Vibration Test|A test used to identify asymmetry that may be present in the vestibular system through 60-100 MHz vibration applied to the mastoid bone. A WAHL massager is used to stimulate the inner ear by vibrating the mastoid bone. The test is performed both in room light and with fixation blocked with a Micromedical Technologies infrared lens.
16035691|NCT02626026|Drug|Tirabrutinib|Capsules administered orally.
16035692|NCT02626026|Drug|Placebo|Capsules administered orally.
16035693|NCT02626000|Drug|Talimogene Laherparepvec|The initial dose of talimogene laherparepvec is up to 8.0 mL of 10⁶ PFU/mL. Subsequent doses of talimogene laherparepvec are up to 8.0 mL of 10⁸ PFU/mL.
16035694|NCT02626000|Biological|Pembrolizumab|Administered as a 30-minute intravenous infusion at a dose of 200 mg Q3W
16035695|NCT02625987|Procedure|Continuous intradermic stitch|Appendectomy wound closure with an intradermic Polyglactina 910 stitch
16035696|NCT02625987|Procedure|Separated stitches|Appendectomy wound closure with a separated stitches.
16035697|NCT02625974|Drug|Nifurtimox (Lampit, BAYA2502)|"For pediatric subjects with body weight ≤ 40 kg: dosage 10 to 20 mg/kg/day in three divided doses.
~For pediatric subjects with body weight > 40 kg: 8 - 10 mg/kg/day in three divided doses.
~60 days of nifurtimox treatment"
16035698|NCT02625974|Drug|Placebo|Matching placebo
16035699|NCT02625961|Biological|pembrolizumab|
16035700|NCT02625948|Drug|Tranexamic Acid|
16035701|NCT02625922|Drug|Serelaxin|Serelaxin will be administered as a continuous i.v. infusion according to a weight-range adjusted dosing regimen
16035702|NCT02625922|Drug|Placebo|Matching placebo i.v infusion
16035705|NCT02625896|Behavioral|Intervention|Standard skydive from 4 000 m above mean sea level (AMSL) following standard safety recommendations and procedures including, if necessary, standard reserve parachute activation procedures. If necessary for safety, participants are asked to immediately leave the study at will. At 1 500 m AMSL, the participant is asked to begin to slow down the fall rate by increasing the body surface area to the relative wind. At no lower than 1 200 m AMSL, the participant is asked to deploy the main parachute. At main parachute deployment, while maintaining a stable body position with shoulders level to the horizon and unaltered heading, the participant is asked to increase the pitch angle of the long body axis attitude, raising the head, shoulders, and upper body up from the flat belly-to-relative-wind plane to a head-high body position, using any free fall technique the participant is comfortable with - as long as there is NO RISK for an unintentional backflip.
16035706|NCT02625883|Other|Interview|Interview by validated Quality-of-life-questionnaire
16035707|NCT02625870|Drug|Omega-3-Acid Ethyl Esters 90 Soft Capsules|Omega-3-Acid Ethyl Esters 90 Soft Capsules will be provided in 1 g polyacrylate-coated soft gel capsules.Four capsules will be taken with breakfast once per day, for 12 weeks.
16035708|NCT02625870|Drug|Corn Oil|Corn Oil will be provided in 1 g polyacrylate-coated soft gel capsules.Four capsules will be taken with breakfast once per day, for 12 weeks.
16035709|NCT02625857|Biological|JNJ-64041809 (Cohort 1A and 1B)|JNJ-64041809 will be administered IV at a lower dose in Cohort 1A (1x10^8 colony forming units [CFU]) and at a higher dose in Cohort 1B (1x10^9 CFU).
16035710|NCT02625857|Biological|JNJ-64041809 (Cohort 2A and 2B)|JNJ-64041809 will be administered intravenously (IV) once every 21 days at the recommended dose as determined in Cohort 1A or 1B.
16035711|NCT02625844|Other|No intervention|No intervention administered in this study.
16035712|NCT02625831|Other|Biological analysis|"Biological analysis :
~ficolin-3
~anti-ficolin 3 antibodies
~anti-C1q antibodies"
16035713|NCT02625805|Device|EEG monitoring (MindWave by NeuroSky)|EEG evaluation will be conducted for duration of 10 minutes. 5 minutes without auditory stimulation and 5 minutes with auditory stimulation performed using standard headphone or earphones to reduce external noises. Additional EEG monitoring will be performed during performance of a computerized test using MindWave Headset.
16035714|NCT02625805|Device|EEG monitoring (EPOC by Emotiv)|EEG evaluation will be conducted for duration of 10 minutes. 5 minutes without auditory stimulation and 5 minutes with auditory stimulation performed using standard headphone or earphones to reduce external noises.
16035715|NCT02625805|Drug|Methylphenidate|Methylphenidate will be administered to each of the study participants in both groups in one of the two days on the study selected randomly.
16035716|NCT02625792|Drug|Endo-Clot(TM)|After patients treated with ESD, Hemostatic power was applied on the post-resection surface by Endo-Clot™ system. And treated with proton pump inhibitor as usual.
16035717|NCT02625779|Drug|Valproate and Placebo|
16035718|NCT02625779|Drug|Valproate and Cytidine-containing Drug|
16035719|NCT02625779|Drug|Valproate and Creatine-containing Drug|
16035720|NCT02625766|Procedure|LC fracture surgical fixation|
16035721|NCT02625766|Procedure|LC fracture non-operative management|
16035722|NCT02625753|Drug|Codeine|Patients submitted to photorefractive keratectomy received codeine 50mg plus paracetamol 500mg every 6h for 72h after the procedure
16035723|NCT02625753|Drug|paracetamol|Patients submitted to photorefractive keratectomy received codeine 50mg plus paracetamol 500mg every 6h for 72h after the procedure
16035724|NCT02625753|Drug|placebo|Patients submmitted to photorefractive keratectomy received placebo, in the form of a pill of similar appearance to the comparator, every 6h for 72h after the
16035725|NCT02625740|Device|Local exposition of target lesion to high intensity, low-frequency ultrasound|Target lesion was exposed to 60 seconds of high intensity, low-frequency ultrasound generated by the Genesis™ system ( CardioProlific Inc., Hayward, CA). The ultrasound catheter is removed after the exposition.
16035726|NCT02625740|Device|drug eluting ballon angioplasty|Target lesion was treated with an angioplasty, performed using the INPACT Admiral drug eluting ballon (Medtronic)
16035727|NCT02625740|Device|Flow occlusion with an angioplasty balloon|Inflation of a 2 cm long balloon catheter Admiral (Medtronic) , located distally to the treatment area, in order to obtain a flow cessation
16035728|NCT02625740|Drug|Local Paclitaxel infusion|Paclitaxel in a mixture with contrast medium at 1.0 µg/mm³ concentration was delivered to the treatment area for 60 seconds. The column of the Paclitaxel mixture filling the vessel was observed under the fluoroscopy and sustained during 60 seconds. The Paclitaxel /contrast medium mixture was then aspired with a 50 cc syringe and the distal balloon was deflated.
16035729|NCT02625740|Procedure|Angiographic control|A final angiographic control was performed with injection of 10 cc of contrast medium and compared with the pre-procedural one.
16035730|NCT02625727|Other|hyaluronic acid|compare the therapeutic effects of hyaluronic acid injection and hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis
16035731|NCT02625727|Other|hyaluronic acid combined corticosteroid|compare the therapeutic effects of hyaluronic acid injection and hyaluronic acid combined corticosteroid injection to patients with knee osteoarthritis
16035732|NCT02625714|Drug|Renexin®|Cilostazol 100mg/ginko biloba leaf extract 80mg, Immediate release, bid
16035733|NCT02625714|Drug|SID142|Cilostazol 200mg/ginko biloba leaf extract 160mg, Controlled release, qd
16035734|NCT02625701|Procedure|Goal-directed therapy|Optimize CO with additional fluid according to dynamic indices (PPV, SVV, Stroke volume)
16035735|NCT02625701|Procedure|Restrictive fluid therapy|Keep normovolemia with basal crystalloids infusion (3-6 ml/kg/h) and compensate additional fluid losses with colloids or crystalloids.
16035736|NCT02625688|Other|Delayed cord clamping|We have decided to delay cord clamping in the intervention group to 3 minutes and place the baby 10 cm above the placental, as it seems most efficient based on the available literature. At all births (spontaneous vaginal deliveries and caesarian sections) a member of the recruitment team will be present. He will inform the midwife or obstetrician about the allocated intervention and measure the time from the delivery of the shoulders to the cord clamping.
16035768|NCT02625532|Procedure|Follicular phase|Controlled ovarian stimulation starts on day 2-3 of the menstrual cycle with recombinant recombinant FSH + LH, adding cetrorelix when the follicles reach 14 mm size and ovarian maturation with triptorelin acetate
16038336|NCT02607657|Drug|Eplerenone 50 mg twice a day|
16035737|NCT02625688|Other|Cord milking|If cord milking will be the allocated intervention, the recruiter will supervise the midwife, or obstetrician preforming the procedure, and count out loud the number of times the cord has been milked. During vaginal deliveries midwifes will be asked to maintain the infant at least 10 cm above the uterus until the cord is clamped. In case of caesarian sections the baby will be placed on the mother's laps and swaddled in sterile towels to prevent heat loss.
16035738|NCT02625688|Other|Early cord clamping|We have decided to clamp the cord in the early intervention group at 30 seconds and place the baby 10 cm above the placental, as it seems most efficient based on the available literature. At all births (spontaneous vaginal deliveries and caesarian sections) a member of the recruitment team will be present. He will inform the midwife or obstetrician about the allocated intervention and measure the time from the delivery of the shoulders to the cord clamping.
16035739|NCT02625675|Other|Ultrasound scan|
16035740|NCT02625636|Drug|SAR438544|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
16035741|NCT02625636|Drug|placebo|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
16035742|NCT02625636|Drug|r-glucagon|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
16035743|NCT02625623|Drug|Avelumab|Avelumab was administered as a 1-hour intravenous (IV) infusion at 10 milligram per kilogram (mg/kg) once every 2-week treatment cycle until confirmed progressive disease or unacceptable toxicity along with best supportive care (BSC).
16035744|NCT02625623|Drug|Irinotecan|Irinotecan was administered at a dose of 150 mg/m ^2 on Day 1 and 15 of a 4-week treatment cycle until disease progression or unacceptable toxicities along with BSC.
16035745|NCT02625623|Drug|Paclitaxel|Paclitaxel was administered at a dose of 80 mg/m^2 on Day 1, 8, and 15 of a 4-week treatment cycle until disease progression or unacceptable toxicities along with BSC.
16035746|NCT02625623|Other|Best Supportive Care (BSC)|BSC is defined as treatment administered with the intent to maximize Quality of life without a specific antineoplastic regimen and is based on investigator's discretion. BSC was administered once every 3 weeks.
16035747|NCT02625610|Drug|Avelumab|Maintenance Phase: Intravenous (IV) infusion (10 mg/kg over 1 hour) once every 2 weeks.
16035748|NCT02625610|Drug|Oxaliplatin|"Induction Phase: Oxaliplatin will be administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin followed by 5-Fluorouracil every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks up to 12 weeks.
~Maintenance Phase: Subjects will continue the same regimen of chemotherapy as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation."
16035749|NCT02625610|Drug|5-Fluorouracil|Induction Phase: 5-Fluorouracil will be administered at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 (or) 5-FU at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Days 1 and 2) along with oxaliplatin and leucovorin every 2 weeks up to 12 weeks. Maintenance Phase: Subjects will continue the same regimen of chemotherapy as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation.
16035750|NCT02625610|Drug|Leucovorin|"Induction Phase: Leucovorin will be administered at a dose of 200 mg/m^2 IV (or) Leucovorin 400 mg/m^2 IV on Day 1 along with oxaliplatin and 5-FU every 2 weeks up to 12 weeks.
~Maintenance Phase: Subjects will continue the same regimen of chemotherapy as they received during the Induction Phase until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation."
16035751|NCT02625610|Drug|Capecitabine|"Induction Phase: Capecitabine will be administered at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks along with oxaliplatin up to 12 weeks.
~Maintenance Phase: Subjects will continue the same regimen of chemotherapy as they received during the Induction Phase every 3 weeks until disease progression, significant clinical deterioration, unacceptable toxicity, or discontinuation."
16035752|NCT02625610|Other|Best supportive care|Treatment administered with the intent to maximize Quality of Life (QoL) without a specific antineoplastic regimen. These may include for example antibiotics, analgesics, antiemetics, thoracentesis, paracentesis, blood transfusions, nutritional support (including jejunostomy), and focal external-beam radiation for control of pain, cough, dyspnea, or bleeding. Best supportive care will be administered per institutional guidelines and subjects will visit the clinic every 3 weeks.
16035753|NCT02625610|Drug|Oxaliplatin|Induction Phase: Oxaliplatin will be administered at a dose of 85 mg per square meter (mg/m^2) as a continuous intravenous (IV) infusion on Day 1 along with leucovorin followed by 5-Fluorouracil every 2 weeks up to 12 weeks (or) Oxaliplatin at 130 mg/m^2 IV on Day 1 along with capecitabine twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks up to 12 weeks.
16035754|NCT02625610|Drug|5-Fluorouracil|Induction Phase: 5-Fluorouracil will be administered at a dose of 2600 mg/m^2 IV continuous infusion over 24 hours on Day 1 (or) 5-FU at 400 mg/m^2 IV push on Day 1 and 2400 mg/m^2 IV continuous infusion over 46-48 hours (Days 1 and 2) along with oxaliplatin and leucovorin every 2 weeks up to 12 weeks.
16035755|NCT02625610|Drug|Leucovorin|Induction Phase: Leucovorin will be administered at a dose of 200 mg/m^2 IV (or) Leucovorin 400 mg/m^2 IV on Day 1 along with oxaliplatin and 5-FU every 2 weeks up to 12 weeks.
16035756|NCT02625610|Drug|Capecitabine|Induction Phase: Capecitabine will be administered at a dose of 1000 mg/m^2 twice daily for 2 weeks followed by a 1-week rest period given every 3 weeks along with oxaliplatin up to 12 weeks.
16035757|NCT02625597|Device|Cotton Pellet|
16035758|NCT02625597|Device|Polytetrafluoroethylene Tape|
16035759|NCT02625597|Device|Synthetic Foam|
16035760|NCT02625597|Device|Polyvinylsiloxane|
16035761|NCT02625584|Behavioral|Reading Together - Pausing for Reading|
16035762|NCT02625584|Behavioral|Reading Together - Dialogic Reading|
16035763|NCT02625584|Behavioral|Reading Together - Shared Reading Control|
16035764|NCT02625571|Behavioral|Phase-based treatment of sexual behavior problems of children|
16035765|NCT02625558|Drug|Riociguat|Patients will initiated on 0.5 mg tid and titrated every 2 weeks to a maximum of 2.5 mg three times a day
16035766|NCT02625558|Drug|Placebo|Placebo given three times a day
16035767|NCT02625545|Device|UroLift System procedure|Minimally invasive procedure for treatment of lower urinary tract symptoms (LUTS) due to BPH
16035911|NCT02624882|Procedure|Negative rapid GAS test|Usual care
16035769|NCT02625532|Procedure|Luteal phase|Controlled ovarian stimulation is started between 3rd and 5th day after the first LH positive urine test, adding cetrorelix when follicles reached 14 mm size and ovarian maturation with triptorelin acetate
16035770|NCT02625519|Drug|Urinary follicle-stimulating hormone|Ovarian stimulation with highly purified urinary follicle-stimulating hormone
16035771|NCT02625519|Drug|Recombinant follicle-stimulating hormone|Controled ovarian stimulation with recombinant follicle-stimulating hormone
16035772|NCT02625506|Drug|Levobupivacaine|Ultrasound guided Pecs block will be performed using 20 ml of levobupivacaine
16035773|NCT02625506|Drug|Levobupivacaine and Tramadol|Ultrasound guided Pecs block will be performed using 20 ml of levobupivacaine in conjunction with tramadol
16035774|NCT02625493|Other|Questionnaire|Questionnaire containing a Best-worst Scaling scenario
16035778|NCT02625467|Procedure|Penetrating keratoplasty|Conventional Penetrating keratoplasty technique
16035779|NCT02625467|Procedure|Pachymetry and Excimer laser assisted lamellar keratoplasty|Ablation profile focusing on topography and pachymetry with Schwind Amaris excimer laser
16035780|NCT02625467|Drug|Treatment posterior to surgery|Fluoroquinolone topical antibiotic (Moxifloxacin, Vigamox) and topical steroid (Prednisolone Acetate Ophthalmic Suspension, Pred Forte)
16035781|NCT02625454|Drug|Intravenous Acetaminophen|1000 mg Acetaminophen q 6 hours, given intravenously
16035782|NCT02625454|Drug|Oral Acetaminophen|1000 mg Acetaminophen q 6 hours given orally
16035783|NCT02625441|Drug|Pertuzumab|Pertuzumab 420 mg i.v. 3-weekly for 3 cycles
16035784|NCT02625441|Drug|Trastuzumab|Trastuzumab 6 mg/kg, i.v., 3-weekly for for a total duration of one year
16035785|NCT02625428|Drug|Optison|
16035786|NCT02625428|Diagnostic Test|Ultrasound (US)|A routine diagnostic and color-Doppler US. A Doppler ultrasound is a noninvasive test that can be used to estimate the blood flow through your blood vessels by bouncing high-frequency sound waves (ultrasound) off circulating red blood cells. A regular ultrasound uses sound waves to produce images, but can't show blood flow.
16035787|NCT02625428|Diagnostic Test|Contrast-enhanced ultrasound (CEUS)|Contrast-enhanced ultrasound (CEUS) is the application of ultrasound contrast medium to traditional medical sonography. Ultrasound contrast agents rely on the different ways in which sound waves are reflected from interfaces between substances. This may be the surface of a small air bubble or a more complex structure.
16035788|NCT02625415|Device|Vitamin B6 cream|Topical Vitamin B6 cream
16035789|NCT02625415|Device|Placebo Vitamin B6 cream|Placebo Vitamin B6 cream
16035790|NCT02625402|Behavioral|Brief interactive decision aid|The Healthwise Shared Decision Points in booklet version for hip and knee osteoarthritis
16035791|NCT02625402|Behavioral|Long video decision aid|Health Dialog DVD and booklet decision aids for hip and knee osteoarthritis
16035792|NCT02625389|Drug|Lipiodol® Ultra Fluid with surgical glues|Lipiodol® Ultra Fluid and surgical glue mixture may vary from 20 to 80% and should be administered via selective arterial catheterization only.
16035793|NCT02625376|Dietary Supplement|Resvega|Dietary supplementation with Resvega BD
16035794|NCT02625376|Dietary Supplement|Trans-Resveratrol|Dietary supplementation with resveratrol 250 mg BD
16035795|NCT02625376|Dietary Supplement|placebo|Dietary supplementation with a placebo BD
16035796|NCT02625363|Other|Glucose Ref - Std|First, fasting blood glucose was measured. Then, subjects consumed the glucose sample in 5-10 minutes and blood sugar level were measured at 0', 15', 30', 45', 60', 90', and 120'
16035797|NCT02625363|Other|Glucose Ref and 450 ml water|First, fasting blood glucose was measured. Then, subjects consumed the glucose sample in 5-10 minutes. Subjects given additional 150 ml water at 45, 75, and 105 minutes and blood sugar level were measured at 0', 15', 30', 45', 60', 90', and 120
16035798|NCT02625363|Other|White Bread with 250 ml water|First, fasting blood glucose was measured. Then, subjects consumed the samples in 10-15 minutes and blood sugar level were measured at 0', 15', 30', 45', 60', 90', and 120'
16035799|NCT02625363|Other|White Bread and 700 ml water|"Sample consumed with 250 ml water immediately after meal consumption, and additional 150 ml water at 45, 75, and 105 minutes.
~First, fasting blood glucose was measured. Then, subjects consumed the samples in 10-15 minutes and blood sugar level were measured at 0', 15', 30', 45', 60', 90', and 120'"
16035800|NCT02625363|Other|White Bread with 125 ml water (twice)|"Sample consumed with 125 ml water immediately after meal consumption, and additional 125 ml water after 60 minutes
~First, fasting blood glucose was measured. Then, subjects consumed the samples in 10-15 minutes and blood sugar level were measured at 0', 15', 30', 45', 60', 90', and 120'"
16035801|NCT02625350|Other|Instant noodle without soup|First, fasting blood glucose was measured. Then, subjects consumed the sample (instant noodle without soup) and blood sugar level were measured at 0', 15', 30', 45', 60', 90', and 120'
16035802|NCT02625350|Other|Instant noodle with soup|First, fasting blood glucose was measured. Then, subjects consumed the sample (instant noodle with soup) and blood sugar level were measured at 0', 15', 30', 45', 60', 90', and 120'
16035803|NCT02625350|Other|Glucose reference|First, fasting blood glucose was measured. Then, subjects consumed the glucose reference and blood sugar level were measured at 0', 15', 30', 45', 60', 90', and 120'
16035804|NCT02625337|Drug|Pembrolizumab|
16035805|NCT02625337|Drug|Dabrafenib|
16035806|NCT02625337|Drug|Trametinib|
16035807|NCT02625337|Procedure|Biopsy|Biopsies will be taken during screening, before randomization, at week 8 (only arm 2-4) after 12 weeks, at week 18 and if PD.
16035808|NCT02625337|Procedure|Blood taking|Blood will be taken for PBMCs during screening (twice), before randomization, at weeks 12 at week 18 and if PD.
16035809|NCT02625324|Device|Valiant Evo Thoracic Stent Graft System|Procedure: thoracic endovascular aneurysm repair (TEVAR)
16035810|NCT02625311|Procedure|surgery method using CR TKP|Operation through minimal invasive surgery or standard open surgery
16035811|NCT02625298|Device|ProRoot MTA|Apical thirds of the root canals obturated with ProRoot MTA (Dentsply Tulsa Dental Specialties, Tulsa, OK USA).
16035812|NCT02625298|Device|MTA+ Cerkamed|Apical thirds of the root canals obturated with MTA + (Cerkamed, Stalowa Wola, Poland).
16038337|NCT02607657|Drug|Eplerenone 25 mg twice a day|
16035813|NCT02625272|Procedure|Group A|The novel hand-assisted laparoscopic surgery with complete mesocolic excision and central vascular ligation for right colon cancer. In this group, greater omentum, transverse colon, and ileum were brought out through the hand-port incision at the beginning of the operation and divided extracorporeally.
16035814|NCT02625259|Drug|TAK-117|TAK-117 capsules
16035815|NCT02625259|Drug|Lansoprazole|Lansoprazole capsules
16035816|NCT02625259|Drug|TAK-117|TAK-117 tablets
16035817|NCT02625246|Biological|hMSCs|intravenous infusion of bone marrow-derived allogeneic stem cells
16035818|NCT02625233|Device|senofilcon C|
16035819|NCT02625233|Device|comfilcon A|
16035820|NCT02625220|Device|Prototype toric lens senofilcon A|Investigational prototype
16035821|NCT02625207|Drug|Maraviroc (Part 1)|300 mg twice daily x 5 days
16035822|NCT02625207|Drug|Maraviroc (Part 2)|150 mg once daily x 10 days
16035823|NCT02625207|Drug|Darunavir/cobicistat (Part 2)|800/150 mg once daily x 10 days
16035824|NCT02625194|Drug|Oxygen|Oxygen is supplied through suction port during bronchoscope-guided intubation.
16035825|NCT02625181|Procedure|Automated recommendation at the start of the case|The first notification is the main notification that informs the anesthesia providers at the start of anesthesia of the risk score for that individual patient and the recommended number of prophylactic interventions. The notification occurs within the anesthesia information management system (AIMS)
16035826|NCT02625181|Procedure|Automated notification at the start of surgery|The second notification within the AIMS will notify the anesthesia providers at the start of surgery when no prophylaxis has been given while three or more interventions were recommended.
16035827|NCT02625181|Procedure|Preoperative recommendations: by email|A recommendation on PONV prophylaxis to anesthesia providers through email at the Vanderbilt University Medical Center.
16035828|NCT02625181|Procedure|Automated notification at the end of surgery|A notification will remind anesthesia providers at the closing of surgery how many prophylactic interventions are required to adhere to the recommended number of interventions.
16035829|NCT02625181|Device|Anesthesia Information Management System (AIMS)|The anesthesia electronic record keeping system
16035830|NCT02625181|Device|Perioperative Data Warehouse (PDW)|The data warehouse that is used to gather perioperative data and create user reports. In this instance the PDW will be used to send the preoperative emails.
16035831|NCT02625181|Procedure|General anesthesia|Any anesthetic drugs that are used to induce general anesthesia above the level of sedation.
16035832|NCT02625181|Procedure|Elective surgery|Surgical procedures that are scheduled and not an emergency.
16035833|NCT02625181|Drug|Propofol|Anesthetic drug used to maintain general anesthesia
16035834|NCT02625181|Drug|Sevoflurane|Anesthetic drug used to maintain general anesthesia
16035835|NCT02625181|Drug|Isoflurane|Anesthetic drug used to maintain general anesthesia
16035836|NCT02625181|Drug|Desflurane|Anesthetic drug used to maintain general anesthesia
16035837|NCT02625181|Drug|Scopolamine|Prophylactic antiemetic
16035838|NCT02625181|Drug|Droperidol|Prophylactic antiemetic & rescue antiemetic
16035839|NCT02625181|Drug|Haloperidol|Prophylactic antiemetic & rescue antiemetic
16035840|NCT02625181|Drug|Dexamethasone|Prophylactic antiemetic & rescue antiemetic
16035841|NCT02625181|Drug|Promethazine|Prophylactic antiemetic & rescue antiemetic
16035842|NCT02625181|Drug|Meclizine|Prophylactic antiemetic & rescue antiemetic
16035843|NCT02625181|Drug|Aprepitant|Prophylactic antiemetic & rescue antiemetic
16035844|NCT02625181|Drug|Metoclopramide|Rescue antiemetic
16035845|NCT02625181|Drug|Fentanyl|Analgesic drug / Opioid
16035846|NCT02625181|Drug|Sufentanil|Analgesic drug / Opioid
16035847|NCT02625181|Drug|Alfentanil|Analgesic drug / Opioid
16035848|NCT02625181|Drug|Remifentanil|Analgesic drug / Opioid
16035849|NCT02625181|Drug|Morphine|Analgesic drug / Opioid
16035850|NCT02625181|Drug|Meperidine|Analgesic drug / Opioid
16035851|NCT02625181|Drug|Hydromorphone|Analgesic drug / Opioid
16035852|NCT02625181|Drug|Methadone|Analgesic drug / Opioid
16035853|NCT02625181|Drug|Oxycodone|Analgesic drug / Opioid
16035854|NCT02625181|Drug|Oxymorphone|Analgesic drug / Opioid
16035855|NCT02625181|Drug|Hydrocodone|Analgesic drug / Opioid
16035856|NCT02625181|Drug|Ketamine|Analgetic / Analgesic drug
16035857|NCT02625181|Drug|Ondansetron|Prophylactic antiemetic & rescue antiemetic
16035858|NCT02625181|Drug|Granisetron|Prophylactic antiemetic & rescue antiemetic
16035859|NCT02625181|Drug|Dolasetron mesylate|Prophylactic antiemetic & rescue antiemetic
16035860|NCT02625181|Drug|Palonosetron|Prophylactic antiemetic & rescue antiemetic
16035861|NCT02625181|Drug|Tropisetron|Prophylactic antiemetic & rescue antiemetic
16035862|NCT02625181|Drug|Ramosetron|Prophylactic antiemetic & rescue antiemetic
16035863|NCT02625168|Drug|Afatinib|Afatinib from study recruitment until disease progression, intolerable side effects as judged by investigators or patient withdrawal
16035864|NCT02625168|Drug|Erlotinib|Erlotinib from study recruitment until disease progression, intolerable side effects as judged by investigators or patient withdrawal
16035865|NCT02625155|Other|Urine diagnostic testing as SOC, drug regimen changes per SOC|
16035866|NCT02625155|Other|Urine diagnostic testing with selective PGx testing, drug regimen changes based on PGx test results|
16035867|NCT02625142|Other|Family-centered rounds checklist tool|A printed checklist containing 9 key tasks associated with effective delivery of family-centered rounds. A previously-identified member of each rounding team was responsible for holding the printed checklist during morning rounds. Team members were trained the in the use of this checklist prior to the post-intervention period, and a brief refresher training was conducted mid-way through the period.
16035868|NCT02625129|Other|Pharmacist-provided travel care|Subjects will receive a pre-travel consultation from a pharmacist with specialty training in travel medicine, and with authorization to prescribe medications and vaccines and administer injections
16035869|NCT02625103|Procedure|Blood sampling|blood samples for s-clozapine and s-desmethyl-clozapine analysis are collected at 10, 11, 12, 13 and 14 hours post evening-clozapine-administration
16038687|NCT02605135|Device|Continued Pessary Use|Pessary Fitting
16035870|NCT02625103|Drug|Clozapine|Registration of the exact time of drug administration. Also postponement of any morning clozapine administration until ended blood sampling.
16035871|NCT02625090|Drug|UCB0942|"Active Substance: UCB0942
~Pharmaceutical form: Film-coated tablet
~Concentration: 25 mg, 100 mg or 200 mg
~Route of Administration: oral"
16035872|NCT02625077|Procedure|Laparoscopic gastroesophageal valvuloplasty|
16035873|NCT02625077|Procedure|Laparoscopic Toupet fundoplication|
16035874|NCT02625064|Other|Blood samples collection before treatment|
16035875|NCT02625064|Other|Blood samples collection after treatment|
16035876|NCT02625064|Other|laboratory biomarker proteomic analysis|
16035877|NCT02625051|Procedure|Ureteroscopy|Under general anesthesia, the patient is placed in the lithotomy position. All procedures are performed under direct videoscopic and fluoroscopic guidance. Fluoroscopic screening is utilized using a mobile multidirectional C-arm fluoroscopy unit. A safety guide-wire is then placed into renal pelvis, followed by a ureteral access sheath to maintain low intra-renal pressure, and to facilitate the procedures. Using flexible ureteroscope, renal or proximal ureteral stone is identified and fragmented with a holmium laser. Basket extraction of residual fragments is done until visual complete clearance of stone fragments is achieved.
16035878|NCT02625051|Procedure|Percutaneous nephrolithotomy|Under general anesthesia, an open-ended 5 french ureteral exchange catheter is placed into the ipsilateral ureter under cystoscopic guidance. The patient is then safely turned and secured in the prone position. Percutaneous renal access is obtained under ultrasonographic or fluoroscopic guidance. Either a 24 or 30 french sheath is advanced in the kidney and nephroscopy is performed with a rigid offset nephroscope. Stone fragmentation is accomplished using a dual CyberWand lithotripter or holmium laser lithotripsy. Flexible nephroscopy is performed to look for possible residual fragments and basket extraction is done for complete clearance of stone.
16035879|NCT02625038|Device|EUDAMED CIV-14-03-011940|
16035880|NCT02625025|Procedure|Low pression pneumoperitoneum|"Pneumoperitoneum will be obtained by infusing carbon dioxide to distend the peritoneal cavity.
~Intra-abdominal pressure will be maintained at 8 mm Hg during pneumoperitoneum creation and insertion of trocars."
16035881|NCT02625025|Procedure|Standard Pression Pneumoperitoneum|"Pneumoperitoneum will be obtained by infusing carbon dioxide to distend the peritoneal cavity.
~Intra-abdominal pressure will be maintained at 12 mm Hg during pneumoperitoneum creation and insertion of trocars."
16035882|NCT02625025|Procedure|Single Port Access Laparoscopy|Laparoscopy surgery with use of only one incision of 2 cm in the umbilicus in order to threat benign adnexal pathology
16035883|NCT02624999|Biological|AlloVax™|AlloVax™ combines an anti-tumor effect of mini-transplant procedures with patient specific tumor antigens
16035884|NCT02624999|Drug|Cisplatin|Subjects in the chemotherapy arm will receive up to 6 cycles of cisplatin on day 0 of the 3-week cycle at dose of 80-100 mg/m2 IV and 1000 mg/m2 IV 5FU on days 1-4 of the cycle
16035885|NCT02624986|Drug|Idasanutlin|Participants received idasanutlin film-coated tablets orally at a starting dose of 100 mg daily on Days 1 to 5 of each 28-day cycle. Escalation was to occur in at least 50-mg increments, and daily doses greater than or equal to (≥) 400 mg will be split into twice daily dosing.
16035886|NCT02624986|Drug|Obinutuzumab|Participants received a fixed dose of obinutuzumab 1000 mg intravenous (IV) infusion to be given on Days 1, 8 and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 (1 cycle = 28 days). For eligible participants with FL, post-induction treatment was to be given at a dose of 1000 mg via IV infusion on Day 1 once every 2 months for a maximum of up to 24 months.
16035887|NCT02624986|Drug|Rituximab|Participants received a fixed dose of rituximab, 375 mg/m^2 IV infusion on Day 1 of Cycles 1-6. Post-induction treatment for eligible participants was to be given at a dose of 375 mg/m^2 IV infusion on Day 1 of every other month for up to 6 months, until disease progression or unacceptable toxicity.
16035888|NCT02624973|Drug|Neoadjuvant tamoxifen + goserelin (premenopausal women)|
16035889|NCT02624973|Drug|Neoadjuvant letrozole (postmenopausal women)|
16035890|NCT02624973|Drug|Neoadjuvant endocrine therapy + palbociclib (if lack of response to endocrine therapy alone)|
16035891|NCT02624973|Drug|Neoadjuvant docetaxel + cyclophosphamide|
16035892|NCT02624973|Drug|Neoadjuvant docetaxel|
16035893|NCT02624973|Drug|Neoadjuvant docetaxel + trastuzumab + pertuzumab|
16035894|NCT02624973|Drug|Neoadjuvant docetaxel + cyclophosphamide + trastuzumab + pertuzumab|
16035895|NCT02624973|Drug|Neoadjuvant olaparib|
16035896|NCT02624973|Drug|Neoadjuvant cyclophosphamide (after 10 weeks of olaparib alone)|
16035897|NCT02624973|Procedure|Breast conserving surgery or mastectomy + SNB/axillary dissection|After response to neoadjuvant treatment
16035898|NCT02624973|Radiation|Postoperative radiotherapy breast/chest wall + regional lymph nodes|
16035899|NCT02624973|Drug|Adjuvant trastuzumab|
16035900|NCT02624973|Drug|Adjuvant letrozole (postmenopausal women)|
16035901|NCT02624973|Drug|Adjuvant tamoxifen + goserelin (premenopausal women)|
16035902|NCT02624973|Drug|Adjuvant palbociclib (if palbociclib given neoadjuvant)|
16035903|NCT02624973|Drug|Adjuvant Epirubicin+ Cyclophosphamide|
16035904|NCT02624960|Device|Accucinch Implant|Percutaneous implantation of the Accucinch Implant in the mitral subannular space
16035905|NCT02624947|Biological|RSV F vaccine with adjuvant|
16035906|NCT02624947|Biological|Formulation buffer|
16035907|NCT02624921|Other|There was no intervention.|Participants were transported one day to a urban setting, one day to a green space, one day to a beach. No intervention was done.
16035908|NCT02624908|Drug|canagliflozin|Subjects randomized to active drug will receive canagliflozin 100 mg . If study drug well tolerated, dose will be increased to 300 mg canagliflozin at Visit 4.
16035909|NCT02624908|Drug|placebo|Subjects randomized to placebo will receive 100 mg placebo pill . If study drug well tolerated, dose will be increased to 300 mg placebo pill at Visit 4.
16035910|NCT02624882|Procedure|Positive rapid GAS test|"If TDR positive, the child will be treated with antibiotics alone:
~Amoxicillin 50mg / kg / day in 2 divided doses for 10 days (maximum dose 3 g / day in 2 divided doses) Or if allergic to penicillins and in the absence of cross-known allergy to cephalosporins
~Cefpodoxime 8mg / kg / day in 2 divided doses for 10 days (maximum dose 400mg / day in 2 divided doses) J10 A control visit will review all the children included in the study. If the surgeon deems it necessary, the patient will be reviewed in consultation up to three months."
16038688|NCT02605122|Drug|Solithromycin|
16035913|NCT02624856|Drug|Liposomal bupivacaine|Liposomal bupivacaine (EXPAREL®) 133 mg in 10 mL for quadriceps sparing femoral nerve block and 133 mg in 20 mL for posterior knee compartment periarticular injection.
16035914|NCT02624856|Drug|Bupivacaine plus dexamethasone|Bupivacaine HCl 0.5% 10 mL plus dexamethasone 2 mg for quadriceps sparing femoral nerve block and bupivacaine HCl 0.25% plus dexamethasone 2 mg for posterior knee compartment periarticular injection
16035915|NCT02624843|Drug|Benzyl Alcohol Lotion 5%|White topical lotion
16035916|NCT02624843|Drug|Ulesfia (benzyl alcohol lotion) 5%|White topical lotion
16035917|NCT02624843|Drug|Placebo|White topical lotion
16035918|NCT02624830|Drug|Sulfonylurea|See Arm description.
16035919|NCT02624817|Drug|Sulfonylurea|See Arm description.
16035920|NCT02624804|Biological|Stem Cell Educator Therapy|"Patients will receive apheresis and then have their own blood returned to them with the educated lymphocytes"
16035921|NCT02624791|Device|1-DAY ACUVUE® MOIST contact lenses|spherical contact lenses worn during simulated driving tests
16035922|NCT02624791|Device|1-DAY ACUVUE® MOIST for ASTIGMATISM contact lenses|toric contact lenses worn during simulated driving tests
16035923|NCT02624791|Other|No contact lenses|simulated driving tests
16035924|NCT02624778|Biological|LY3002813|Administered IV
16035925|NCT02624778|Drug|Placebo|Administered IV
16035932|NCT02624752|Dietary Supplement|Ensure|Comparison of enhanced oral nutrition supplementation versus standard of care
16035933|NCT02624739|Device|Reassure Non-Contact Respiration Monitor|Reassure uses a specially-designed, non-contact motion sensor to monitor body movement and continuous respiratory rate (CRR) during sleep. Reassure is used to monitor, over a prolonged period, the sleep patterns and respiration rate while the patient is asleep.
16035934|NCT02624726|Drug|5 Fluorouracil|5 Fluorouracil: 400mg/m2, bolus infusion in <5min followed by 5 Fluorouracil: 2400mg/m2, i.v in 46 hours continuous infusion (cycle repeated every two weeks)
16035935|NCT02624726|Drug|Leucovorin|Leucovorin: 400mg/m2, i.v in 2 hours infusion (cycle repeated every two weeks)
16035936|NCT02624726|Drug|Irinotecan|Irinotecan: 180mg/m2, i.v in 90min infusion (cycle repeated every two weeks)
16035937|NCT02624726|Drug|Aflibercept|Aflibercept: 4mg/kg i.v in 1 hour infusion (cycle repeated every two weeks)
16035938|NCT02624713|Behavioral|obesity treatment|"Parents' education groups for nutrition and healthy behavior with a dietician and a social worker every 2 weeks for5 months, for a total of 10 meetings. This part of the intervention aimed at providing parents with effective tools for modification of lifestyle and the family environment.
~Children's individual therapy consisted of 6 individual meetings with a family physician, a physical therapist specializing in children's physical activity, and a dietician. This part of the intervention aimed at modifying nutrition and lifestyle; the physical therapist can help children incorporate physical activity into their routine.
~Physical activity groups for the children, with individual physical fitness monitoring. twice a week for 6 months. ."
16035939|NCT02624700|Drug|Experimental Arm A: Pemetrexed|Treatment schedule is administered on day 1 of each 14-day cycle by Intravenous infusion over 10 minutes with a dose of 500 mg/m2. If necessary, the duration of the pemetrexed infusion may be extended to a maximum of 20 minutes.
16035940|NCT02624700|Drug|Experimental Arm A: Sorafenib|Treatment schedule is administered twice daily by mouth on an empty stomach on days 1-5 of each 14-day cycle with a dose of 400 mg.
16035941|NCT02624700|Drug|Experimental Arm B: Pemetrexed|Treatment schedule is administered on day 1 of each 21-day cycle by Intravenous infusion over 10 minutes with a dose of 375 mg/m2. If necessary, the duration of the pemetrexed infusion may be extended to a maximum of 20 minutes.
16035942|NCT02624700|Drug|Experimental Arm B: Sorafenib|Treatment schedule is administered twice daily by mouth on an empty stomach on days 1-5 of each 21-day cycle with a dose of 200 mg.
16035943|NCT02624687|Behavioral|Intervention|Participants participated in monthly, individual counselling with a trained interventionist to decrease sedentary behavior and improve pain self-management. Participants were provided with a sit-stand desk attachment and a wrist worn activity prompter..
16035944|NCT02624687|Other|No intervention|No contact control
16035945|NCT02624674|Device|Multi-spectral Imaging Device (MSID)|
16035946|NCT02624661|Drug|Glycerol|
16035947|NCT02624648|Behavioral|The Female Sexual Function Index (FSFI)|The Female Sexual Function Index (FSFI) Questionnaire to evaluate the sexual function
16035948|NCT02624648|Behavioral|The Female Intervention Efficacy Index (FIEI)|The Female Intervention Efficacy Index Questionnaire (FIEI) to evaluate the sexual function
16035949|NCT02624648|Behavioral|The Beck Depression Inventory II|The Beck Depression Inventory II will be used to evaluate or ward off depression
16035950|NCT02624648|Drug|Lepidium Meyenii Walp|They will receive a capsule of Lepidium Meyenii Walp twice a day for 120 days
16035951|NCT02624648|Drug|Placebo|They will receive a capsule of Placebo twice a day for 120 days
16035952|NCT02624635|Other|Manual Therapy|The scheme established for that intervention is as follows: joint manipulation passive ankle and foot, myofascial release technique (gastrocnemius, soleus muscle and plantar fascia), neural mobilization (nerve tibial) and stretching the plantar region and sural triceps, following the recommendations described by Mcpoil et al. (2008).
16036005|NCT02624297|Other|Aerobic exercise training|The patients will be submitted to four months of aerobic exercise training, three time a week.
16036044|NCT02623985|Device|Throat swab culture|Patients who presented with sore throat will be performed throat swab and sent for throat swab culture for gold standard.
16036045|NCT02623972|Drug|Eribulin|administered IV for 4 cycles
16036046|NCT02623972|Drug|Adriamycin|administered IV with cyclophosphamide for 4 cycles
16038757|NCT02604589|Drug|bupivicaine 0.5%|High dose analgesia
16035953|NCT02624635|Other|Manual Therapy and Hip Strengthening|It will be done the same treatment performed in group 1 plus the strengthening of the muscles of the hip (iliac muscle, psoas, gluteus maximus, gluteus medius and gluteus minimus) and the treatment schedule established for this intervention is the use of exercises with progressive resistance. Will be performed 3 sets of 10 reps with 30 seconds rest between each set, according to the guidelines of the American College of Sports Medicine (ACSM, 2014). The home exercises consist of repeating the same procedures performed for supervised strengthening. The calculation of the ideal individual load will be carried by Brzycki formula, i.e. one repetition maximum (1RM) = weight ÷ [1.0278 - (0.0278 x number of repetitions)] as was used by (Shirazi et al., 2007).
16035954|NCT02624622|Procedure|Chlorhexidine application to cord by mother|
16035955|NCT02624622|Procedure|Chlorhexidine application by CHW|
16035956|NCT02624609|Other|Control without pomegranate juice|Control meal of 109 g white bread and 200 ml water (containing the same amount and type of sugars naturally present in pomegranate juice) to which the response of the test meal with pomegranate juice will be compared to.
16035957|NCT02624609|Other|Test with pomegranate juice|The test meal will contain 109 g white bread and 200 ml of pomegranate juice whose response will be compared to that of the control meal.
16035958|NCT02624596|Drug|Ketamine|OCD patients in this arm will receive 0.5mg/kg of ketamine - one single infusion
16035959|NCT02624596|Drug|Midazolam|OCD patients in this arm will receive 0.045mg/kg of midazolam - one single infusion
16035960|NCT02624570|Drug|Midostaurin|Midostaurin, also known as PKC412 is a multi-kinase inhibitor of FLT3 (fms-like tyrosine kinase-3)
16035961|NCT02624557|Drug|Alpelisib|Subjects will receive a single dose of 300 mg alpelisib.
16035962|NCT02624544|Drug|esomeprazole|esomex 40 mg twice daily
16035963|NCT02624544|Drug|desonide|topical corticosteroid desonid 0,1% b.i.d
16035964|NCT02624531|Drug|Taxane|NACT and Fertility-sparing Treatment Strategy
16035965|NCT02624531|Procedure|radical trachelectomy|NACT and Fertility-sparing Treatment Strategy
16035966|NCT02624518|Drug|Gallium Ga 68-labeled GRPR Antagonist BAY86-7548|Imaging with PET/MRI
16035967|NCT02624518|Procedure|Magnetic Resonance Imaging|Imaging with 68Ga-RM2 PET/MRI
16035968|NCT02624518|Procedure|Positron Emission Tomography|Imaging with 68Ga-RM2 PET/MRI
16035969|NCT02624505|Drug|90 mcg Reference Product|Drug: 90 mcg Reference Product
16035970|NCT02624505|Drug|180 mcg Reference Product|Drug: 180 mcg of Reference Product
16035971|NCT02624505|Drug|90 mcg Test Product|Drug: 90 mcg of Test Product
16035972|NCT02624505|Drug|Placebo|Placebo Product
16035973|NCT02624492|Drug|BI 836826|
16035974|NCT02624492|Drug|GemOx|
16035975|NCT02624492|Drug|Rituximab|
16035976|NCT02624492|Drug|GemOx|
16035977|NCT02624479|Drug|Sodium thiosulfate|oral administration of thiosulfate
16035978|NCT02624466|Other|CKD progress|CKD progress
16035979|NCT02624453|Drug|Fluconazole|Pre-emptive fluconazole therapy at 800mg/day for two weeks, then 400mg/day for eight weeks, and then 200mg/day thereafter till CD4 count goes beyond 200cells/ml
16035980|NCT02624453|Drug|Antiretroviral therapy|First line anti-retroviral therapy according to Cameroon national guidelines for the management of HIV/AIDS
16035981|NCT02624440|Drug|Standard myeloma treatment|The choice of myeloma standard treatment is at the discretion of the treating investigator guided by the national Danish guidelines for treatment of multiple myeloma
16035982|NCT02624440|Drug|Clarithromycin|P.o. clarithromycin 250 mg twice daily
16035983|NCT02624440|Drug|Sulfamethoxazole/trimethoprim|P.o. sulfamethoxazole/trimethoprim 400/80 mg twice daily
16035984|NCT02624440|Drug|Observation|Observation without prophylactic antibiotic
16035985|NCT02624427|Device|Measurement of intraocular pressure (IOP)|Measurement of IOP with the following devices: (1) Goldmann tonometer, (2) Dynamic Contour tonometer, and (3) Corvis ST tonometer
16035986|NCT02624414|Device|PillCam® COLON 2 Capsule Endoscopy|
16035987|NCT02624401|Drug|Dexmedetomidine|Intravenous infusion
16035988|NCT02624401|Drug|Propofol|Intravenous infusion
16035989|NCT02624401|Drug|S-ketamine|Intravenous infusion
16035990|NCT02624401|Drug|Sevoflurane|Inhalation
16035991|NCT02624401|Drug|Placebo|Intravenous infusion of saline (Ringer's Acetate)
16035992|NCT02624388|Drug|Genistein|Estrogen-like compound (isoflavone) derived from soybeans
16035993|NCT02624388|Drug|Placebo|Pill that contains no medicine
16035994|NCT02624375|Drug|Zoster Vaccine Live|
16035995|NCT02624362|Behavioral|Therapeutic Suggestion|suggestions about potential beneficial effects of the odor are given
16035996|NCT02624362|Behavioral|Asthmogenic Suggestion|suggestions about potential negative effects of the odor are given
16035997|NCT02624362|Other|Phenylethyl Alcohol odor|Over the course of 15 minutes, participants, receive 15 short sniffs of Phenylethyl Alcohol odor
16035998|NCT02624349|Drug|Quadravalent human papillomavirus vaccine|Vaccine will be administered to all transplant recipients. Controls will be recruited based on previous documented receipt of vaccine
16035999|NCT02624336|Other|DTC1|15ml DTC1 twice a day, rinse for 30sec refrain from eating or drinking for 30min
16036000|NCT02624336|Other|Oradex|15ml Chlorhexidine gluconate 0.12% (w/v) twice a day, rinse for 30sec refrain from eating or drinking for 30min
16036001|NCT02624336|Other|Distilled water|15ml distilled water twice a day, rinse for 30sec refrain from eating or drinking for 30min
16036002|NCT02624323|Procedure|Real-time ultrasound-guided central vein catheterization.|
16036003|NCT02624310|Drug|Droxidopa (L-DOPS)|Patients will be given their initial 100 mg of L-DOPS (visit 2a). The dose of L-DOPS will be increased in escalation in the following visits. Each day the dose will be increased 100 mg. The escalating doses of L-DOPS will be 200 mg (visit 2b), 300 mg (visit 2c), 400 mg (visit 2d), 500 mg (visit 2e) and 600 mg (visit 2f). Following this titration step, L-DOPS will be withdrawn from the subjects for a minimum of two weeks, when the subject will return for visit 3.Visit 3a,b,c,d,e,f: Carbidopa open-label dose titration. This titration step will be similar than L-DOPS titration. Carbidopa starting dose will be 100 mg (visit 3a) and will be increased 100 mg each visit up to a maximum of 600 mg (visit 3f). Following carbidopa titration step, patients will be withdrawn from the drug for minimum of two weeks, then the subject will return for the next titration step (visit 4).
16036004|NCT02624310|Drug|Placebo|
16036006|NCT02624284|Device|transcranial direct current stimulation (tDCS)|"Active tDCS: A neuroConn DC-Stimulator Plus will apply a constant direct current (1.0 mA to 2.0 mA via 5x7 electrode) to the left dorsal lateral prefrontal cortex. Each participant will receive anodal stimulation for a period of 20 minutes. For anodal stimulation over the left DLPFC, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area (international EEG 10/20 system).
~Sham tDCS: During sham tDCS, a 1.0 mA to 2.0 mA current will be delivered for approximately 30 seconds before being extinguished over a course of seconds. Again, the anodal electrode will be placed over the left F3 and the cathodal electrode over the right supraorbital area. Most participants cannot distinguish between real and sham tDCS."
16036007|NCT02624271|Other|blood samples analysis|Analyze blood samples with GastroPanel test to detect gastric precancerous lesions.
16036008|NCT02624258|Biological|CD19 RNA redirected autologous T-cells (RNA CART19 cells)|Subjects will be treated with IV administration of RNA anti-CD19 CAR T cells for a total of six doses over 3 weeks. The first dose will be administered 1-4 days after infusion of cyclophosphamide 30mg/kg.
16036009|NCT02624245|Other|Conventional Physical Therapy|
16036010|NCT02624219|Drug|AS03|AS03 oil-in-water emulsion adjuvant.
16036011|NCT02624219|Drug|MF59 adjuvant|Microfluoridized adjuvant 59 (MF59) is an oil-in-water emulsion.
16036012|NCT02624219|Biological|Monovalent Influenza A/H5N8 vaccine|Monovalent inactivated influenza A/H5N8 virus vaccine for IM injection. prepared from influenza virus propagated in chicken egg fluid using seed virus prepared from the candidate vaccine virus (CVV), influenza virus A/gyrfalcon/Washington/41088-6/2014(H5N8)-PR8-IDCDC-RG43A (abbreviated as IDCDC-RG43A).
16036013|NCT02624206|Dietary Supplement|Juice A|Subjects to be given juice daily for 3 weeks.
16036014|NCT02624206|Dietary Supplement|Juice B|Subjects to be given juice daily for 3 weeks.
16036015|NCT02624193|Behavioral|MBSR Program|Mindfulness-based stress reduction, as described previously.
16036016|NCT02624193|Behavioral|HT Program|Health education curriculum, as described previously
16036019|NCT02624167|Drug|NW-3509A|Patients will be given oral doses of 15, 20 and 25 mg BID of NW-3509A
16036020|NCT02624167|Drug|Placebo|Patients will be given oral dose of matching Placebo
16036021|NCT02624154|Procedure|pancreatectomy|Remove the pancreatic neuroendocrine tumor by surgery
16036022|NCT02624141|Drug|Epoetin Beta|Dosage at Initiation: Subcutaneous injection of 30000 IU administered once a week. Dosage could be increased to 30000 IU twice a week or 60000 IU once a week after 4 weeks if a blood transfusion was required or hemoglobin level did not increase by at least 0.5 grams per deciliter (g/dL) versus baseline.
16036023|NCT02624128|Drug|Valproic Acid|Treatment will be administered orally starting at day -14, with 500 mg slow releasing tablet at evening. Thereafter, the dose will be increased also using 300 mg tablets until reaching 1500 mg on day -1. The titration strategy is to reach a target VPA serum level of 50-100 μg/ml.
16036024|NCT02624128|Drug|Cisplatin|administered intravenously at dose of 75 mg/m2 given every three weeks for 6 cycles
16036025|NCT02624128|Drug|Cetuximab|administered intravenously at induction dose of 400 mg/m2 followed by maintenance doses of 250 mg/m2 given weekly
16036026|NCT02624102|Behavioral|Trial based cognitive therapy|Patients with MDD, in use of antidepressants plus Trial Based Cognitive Therapy
16036027|NCT02624102|Behavioral|Behavioral Activation|Patients with MDD, in use of antidepressants plus Behavioral Activation
16036028|NCT02624102|Drug|Antidepressants|Patients with MDD, in use of antidepressants (fluoxetine, citalopram, escitalopram, bupropion, etc.) without psychotherapy.
16036029|NCT02624089|Drug|Ropivacaine|Ropivicaine will be administered via in-line nebulization using the Aeroneb Pro™ system
16036030|NCT02624089|Drug|Normal saline|Normal saline will be administered via in-line nebulization using the Aeroneb Pro™ system
16036031|NCT02624076|Other|Acupuncture|semi-fixed protocol will be used including four local core points; conception vessel (CV) 3, CV 6, and stomach (ST) 29 bilaterally and four in the leg/feet; spleen (SP) 6, and SP 9 bilaterally. The core points CV 3, CV 6, ST 29, SP 6, and SP 9 are thereafter connected to electrical stimulator (Hwoto, China) and stimulated with low-frequency, 2Hz, 0.5 ms
16036032|NCT02624076|Other|expectant management|one initial counselling session, an information leaflet on timed intercourse, access to a telephone helpline for queries and ad hoc support on demand from the fertility clinic over a period of 4 months post randomization.
16036033|NCT02624063|Drug|Daclatasvir + Sofosbuvir|Sofosbuvir 400 mg tablet + Daclatasvir 60 mg tablet oral dosing once daily for 12 weeks
16036034|NCT02624063|Drug|Simeprevir + Sofosbuvir|Sofosbuvir 400 mg tablet + Simeprevir 150 mg tablet oral dosing once daily for 12 weeks
16036035|NCT02624050|Drug|Methohexital|Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.
16036036|NCT02624050|Drug|Propofol|Both drugs of interest are standard of care for use as general anesthetics. The purpose of the study is the determine the susceptibility of both drugs to inducing a hypotensive event.
16036037|NCT02624037|Other|Individualized Dosage Precision IFX Dashboard|Pharmacokinetic Dashboard Recommended Dosage and Dosing Frequency of Infliximab
16036038|NCT02624011|Behavioral|7 days of habitual physical activity followed by 7 days of reduced physical activity|Young, active participants will undergo a 7 day period of habitual physical activity followed by a 7 day period of step reduction and exercise cessation.
16036039|NCT02623998|Drug|insulin glargine|Dose is titrated to achieve fasting normoglycemia
16036040|NCT02623998|Drug|sitagliptin/metformin|Dose is titrated to 50/1000 mg bid or maximal tolerated dose
16036041|NCT02623998|Behavioral|lifestyle therapy|Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving
16036042|NCT02623985|Device|Sofia|Patients who presented with sore throat will be performed throat swab and sent for Sofia for rapid test.
16036043|NCT02623985|Device|QuickVue|Patients who presented with sore throat will be performed throat swab and sent for QuickVue for rapid test.
16038759|NCT02604576|Drug|Bromopride 10 mg|Bromopride 10 mg
16036048|NCT02623959|Behavioral|Questionnaires|Symptom and quality of life questionnaires completed at baseline and at 10 - 14 days after receiving Saline or Doxycycline.
16036049|NCT02623959|Drug|Fentanyl Patch|Participant given a Fentanyl patch, 12 mcg/hour, which should be worn at follow up visit 5 days after IPC placement.
16036050|NCT02623959|Drug|Fentanyl (IV)|Fentanyl 50 mcg given by vein prior to catheter draining.
16036051|NCT02623959|Other|Saline|Catheter is drained then Saline placed in the catheter. Catheter is capped for 1 hour and then drained again.
16036052|NCT02623959|Drug|Doxycycline|Catheter is drained then Doxycycline 500 mg placed in the catheter. Catheter is capped for 1 hour and then drained again.
16036053|NCT02623959|Behavioral|Phone Calls|After the IPC is removed, participant is called one time each month by study staff to check on their status.
16036054|NCT02623933|Radiation|MRI assisted focal boost with HDR monotherapy|Prior to brachytherapy treatment, a multiparametric MRI will be obtained for identification of the dominant intraprostatic lesion (DIL) and fused with the preplanning transrectal ultrasound. A total of 19 Gy will be prescribed to the prostate, organ at risk limits will be observed and up to 22.5 Gy can be delivered to the DIL
16036055|NCT02623920|Drug|Brentuximab|Brentuximab vedotin IV over 30 minutes on day 1.Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
16036056|NCT02623920|Drug|Bendamustine|Bendamustine IV over 30-60 minutes on days 1-2. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
16036057|NCT02623920|Drug|Rituximab|Rituximab IV on day 2. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
16036058|NCT02623881|Device|Cervical pessary|Arabin (cervical pessary) will be inserted at 16-22 weeks and removed at 36 weeks of pregnancy or in case of premature rupture of membranes, signs of preterm labour or patient severe discomfort
16036059|NCT02623881|Drug|Vaginal progesterone|Vaginal progesterone (Cyclogest 400 mg) once a day will be used, from 16-22 to 36 weeks of pregnancy or in case of premature rupture of membranes, signs of preterm labour or patient severe discomfort
16036060|NCT02623868|Drug|CKD-519 50mg 2Tabs.|after taking Standard meal, CKD-519 50mg 2Tabs. administration.
16036061|NCT02623868|Drug|CKD-519 100mg 1Tab.|after taking Standard meal, CKD-519 100mg 1Tab. administration.
16036062|NCT02623868|Drug|CKD-519 100mg 1Cap.|after taking Standard meal, CKD-519 100mg 1Cap. administration.
16036063|NCT02623855|Behavioral|Family outings|Participants will be invited to three weekly outings to local parks, case management and support in getting to nature. Participants will be offered transportation to the outings and s meal at local nature destinations. Programming at the park will include a picnic and walk with nature exploration, and will be facilitated by park and clinic staff.
16036064|NCT02623855|Behavioral|Park prescription|Participants will receive a map of local parks, and the recommendation to be physically active outdoors three days a week in nature.
16036065|NCT02623855|Device|Pedometry|Participants will record their daily pedometry.
16036066|NCT02623855|Behavioral|Case Management|Participants will receive a phone call to list potential barriers to participating in nature outings, and will talk through solutions with an investigator. Participants will be offered assistance with transportation if necessary.
16036067|NCT02623842|Device|Tonederm® (Radiofrequency non ablative)|The application of RF was performed by physical therapist trained in the technique of radio frequency through the Tonederm® brand device with capacitive transfer method using non-ablative handle with electrode in the region of the external urethral meatro and coupling electrode placed on the participant's back. For application, the participants were in gynecological position. The session had an average duration of 20 minutes. The temperature was measured by an infrared thermometer when it reached 41graus radiofrequency was maintained for 2 minutes.
16036068|NCT02623829|Drug|Botulinum Toxin|50 units of botulinum toxin diluted in 1ml of normal saline will be administered.
16036069|NCT02623829|Drug|Saline|1ml of normal saline will be administered
16036070|NCT02623816|Drug|Optimal Dosing of Omeprazole|Omeprazole 20 mg
16036071|NCT02623803|Drug|Lidocaine|
16036072|NCT02623803|Drug|Placebo D5W|
16036073|NCT02623790|Other|Test meal (butter)|Subjects will eat one meal test containing 33g of lipids from butter (percent of total caloric intake: 15.0% from proteins; 53.0% from carbohydrates; 32.0% from fat).
16036074|NCT02623790|Other|Test meal (cheddar cheese)|Subjects will eat one meal test containing 33g of lipids from cheddar cheese (percent of total caloric intake: 15.0% from proteins; 53.0% from carbohydrates; 32.0% from fat).
16036075|NCT02623790|Other|Test meal (cream cheese)|Subjects will eat one meal test containing 33g of lipids from cream cheese (percent of total caloric intake: 15.0% from proteins; 53.0% from carbohydrates; 32.0% from fat).
16036076|NCT02623777|Dietary Supplement|Arabinoxylan oligosaccharides|Arabinoxylan oligosaccharides administered
16036077|NCT02623777|Dietary Supplement|Short chain fatty acids|Short chain fatty acids administered
16036078|NCT02623751|Drug|KHK2375|"KHK2375 will be orally administered once weekly. KHK2375 in combination with exemestane will be repeatedly administered in a 28-day cycle.
~Exemestane will be orally adminitered once daily."
16036079|NCT02623751|Drug|Exemestane|"KHK2375 will be orally administered once weekly. KHK2375 in combination with exemestane will be repeatedly administered in a 28-day cycle.
~Exemestane will be orally adminitered once daily."
16036080|NCT02623738|Drug|Placebo ophthalmic solution|
16036081|NCT02623738|Drug|DE-117 ophthalmic solution low|
16036082|NCT02623738|Drug|DE-117 ophthalmic solution high|
16036083|NCT02623738|Drug|Latanoprost ophthalmic solution 0.005%|
16036084|NCT02623725|Biological|CYD Dengue Vaccine (5-dose formulation)|0.5 mL, Subcutaneous
16036085|NCT02623725|Biological|Placebo, NaCl 0.9%|0.5 mL, Subcutaneous
16036086|NCT02623712|Other|More Frequent Surveillance Strategy|Chest CT scans to be repeated at 3, 6, 12 and/or 24 months, depending on patient risk factors and nodule size and attenuation (density)
16036087|NCT02623712|Other|Less Frequent Surveillance Strategy|Chest CT scans to be repeated at 3, 6, 12 and/or 24 months, depending on patient risk factors and nodule size and attenuation (density). Overall, participants in the less frequent arm are expected to undergo 30% fewer surveillance imaging tests.
16036088|NCT02623699|Drug|BIIB067|Part A, B and C
16036089|NCT02623699|Other|Placebo|Part A, B and C
16036091|NCT02623673|Drug|simultaneous treatment with intravitreal injection of bevacizumab 1.25mg and intravitreal implant of dexamethasone 0.7mg.|
16036092|NCT02623660|Device|ODIN1|"Shortly after surgery, electrodes will be applied to the lower extremity in such a way that the current will flow from the ankle through the knee replacement and pass through the thigh. The frequency of the treatments will vary over the period of time from post-op recovery to end of rehab.
~All treatments are applying current that consists of different combinations of intensities within the micro to nano ampere ranges."
16036093|NCT02623660|Other|Standard Care|Anti-thrombotic medication. Elevation and ice. Pain medications as needed. Dressings changes. Topical antibiotics. Progressive physical therapy.
16036094|NCT02623660|Device|Diagnostic Device Testing|Diagnostic interventions include: the Perometer which scans the lower extremity and determines its volume to a high degree of accuracy; the Impedimed Bioimpedance Spectroscopy (BIS) device that measures intra and intercellular fluid movement; the Microfet muscle force testing device that provides a digital output of the number of pounds exerted by the quadriceps upon extension; the Acumar digital digital Inclinometer that accurately measures the ROM of the knee; and the K.I.S.S. wound measuring system to measure rate of incision healing.
16036095|NCT02623647|Radiation|stereotactic body radiotherapy SBRT|40 Gy in 3 fractions to the prostate gland delivered with stereotactic body radiotherapy
16036096|NCT02623634|Behavioral|Position, waveform|different positions and waveform
16036097|NCT02623621|Drug|chemotherapy plus bevacizumab|Every chemotherapy regimen combined with bevacizumab is allowed
16036098|NCT02623608|Other|Reference breakfast|A high fat, high calorie breakfast
16036099|NCT02623608|Other|Active Ingredient 1|A high fat, high calorie breakfast including the Active Ingredient 1
16036100|NCT02623608|Other|Active Ingredient 2|A high fat, high calorie breakfast including the Active Ingredient 2
16036101|NCT02623608|Other|Active Ingredient 3|A high fat, high calorie breakfast including the Active Ingredient 3
16036102|NCT02623608|Other|Active Ingredient 4|A high fat, high calorie breakfast including the Active Ingredient 4
16036103|NCT02623595|Radiation|Stereotactic body radiotherapy|A type of radiation therapy
16036104|NCT02623595|Drug|rhGM-CSF|Immune modulating agents
16036105|NCT02623582|Biological|Autologous Anti-CD 123 CAR TCR/4-1BB-expressing T-lymphocytes|Given IV
16036106|NCT02623582|Drug|Cyclophosphamide|Given IV
16036107|NCT02623569|Drug|Ivabradine|Not Provided
16036108|NCT02623569|Drug|Atenolol|Not Provided
16036109|NCT02623556|Biological|ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm|All subjects including TB subjects and non-TB subjects with lung disease inject ESAT6-CFP10 (10ug/ml) in left arm and TB-PPD in right arm respectively. Two drug must use at the same participant and in different arms.
16036110|NCT02623556|Biological|ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm|All subjects including TB subjects and non-TB subjects with lung disease inject ESAT6-CFP10 (10ug/ml) in right arm and TB-PPD in left arm respectively. Two drug must use at the same participant and in different arms.
16036111|NCT02623543|Device|OrthoK|
16036112|NCT02623530|Other|Educational intervention|"Control Group: An educational intervention focusing on first aid for the development of skills and dispositions of critical thinking. For this group will be taught the contents of first aid through the Methodology of PBL without the support MEAPC.
~Experimental Group: An educational intervention focusing on first aid for the development of skills and dispositions of critical thinking. For this group will be taught the contents of first aid through Methodology PBL, supported by the MEAPC."
16036113|NCT02623504|Drug|Carbamazepine|200-1200 mg by mouth daily given in divided doses in the morning and the evening. Doses are titrated weekly in 200 mg increments based upon subject's response.
16036114|NCT02623504|Drug|Placebo|Dosage to match active treatment by mouth twice daily in the morning and in the evening.
16036115|NCT02623491|Drug|JNJ-55375515|Participants will receive JNJ-55375515 at a starting dose of 0.75 milligrams (mg) and maximum escalated dose will be 200 mg.
16036116|NCT02623491|Drug|Placebo|Participants will receive matching placebo.
16036117|NCT02623478|Drug|Insulin Lispro|Administered subcutaneously (SC)
16036118|NCT02623465|Drug|Insulin Lispro|Administered subcutaneously (SC)
16036119|NCT02623452|Drug|Insulin Lispro|Administered subcutaneously (SC)
16036120|NCT02623439|Drug|Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant|Cyclophosphamide 50 mg/kg IV Days 3 and 4 post transplant
16036121|NCT02623426|Drug|Dexamethasone intravitreal implant 0.7 mg|Standard preparation as described for intravitreal injections.
16036122|NCT02623426|Drug|Intravitreal Methotrexate 400 µg|Intravitreal Methotrexate 400 µg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to the injection.
16036123|NCT02623426|Drug|Intravitreal Ranibizumab 0.5 mg|Intravitreal Ranibizumab 0.5 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to the injection.
16036124|NCT02623387|Procedure|Ultrasound guided paravertebral block|Paravertebral blocks is a regional anaesthetic technique in which thoracic spinal nerves are inhibited for post operative analgesia in patients undergoing breast surgery. The site of injection can be determined using anatomical landmarks (standard) or using ultrasound guidance.
16036125|NCT02623374|Behavioral|self-help CBT intervention (SHCBT)|See 'Arms' section
16036126|NCT02623361|Drug|Peripheral Nerve Block|Regional Anesthesia by Local Anesthetic Injection
16036127|NCT02623361|Drug|Sham Block|Sham Block by saline injection
16036128|NCT02623348|Behavioral|pedometer|pedometer-based physical activity recommendations
16036129|NCT02623335|Other|QPL (question prompt list) brochure|The QPL intervention includes the QPL intervention brochure, plus a letter from the surgeon encouraging its use during the upcoming office visit. Intervention materials will be mailed in advance of the patient's appointment with an enrolled surgeon.
16036130|NCT02623322|Drug|MHAA4549A|MHAA4549A will be administered as a single dose by IV administration.
16036131|NCT02623322|Drug|Placebo|Placebo will be administered as a single dose by IV administration.
16036133|NCT02623296|Drug|GLPG1205|Once daily administration of 2 GLPG1205 capsules from Day 1 to Day 13
16036134|NCT02623296|Drug|Placebo|Once daily administration of 2 matching placebo capsules from Day 1 to Day 13
16036135|NCT02623296|Drug|Cocktail of CYP450 substrates|Single administration on Day 13 of cocktail of CYP450 substrates: warfarin tablet, omeprazole capsule and caffeine oral solution
16036136|NCT02623283|Other|No intervention given|Participants will have a full dental examination but no operative intervention
16036137|NCT02623270|Device|Noninvasive Ventilator, V60 (Philips)|The noninvasive ventilator will be set to deliver 10 breaths per minute with a pressure setting of 8 cm H2O during exhalation and 20 cm H2O during inspiration. The inspired oxygen fraction given by the ventilator will be set at the maximum level (100% oxygen).
16036138|NCT02623270|Device|Manual Bag|Oxygen will flow through the standard breathing circuit with the fresh gas flow rate set at 10 L/min and the patient will be ventilated. The anesthesia provider will manually bag mask ventilate the patient until the anesthesiologist feels comfortable that the patient can be ventilated appropriately.
16036139|NCT02623257|Other|mutation detection|
16036140|NCT02623257|Other|ARMS|
16036141|NCT02623257|Genetic|ctDNA analysis|
16036142|NCT02623244|Procedure|Laparoscopic oophorocystectomy or oophorectomy|
16036143|NCT02623231|Drug|Escitalopram|Group number 1 will include 50 patients, who will receive Escitalopram at a dose of 10 mg for a week exceeding 20 mg immediately after diagnosis for 3 months
16036144|NCT02623231|Drug|placebo|group # 2 Will include 50 patients , who will receive placebo at a dose of 10 mg for a week exceeding 20 mg immediately after diagnosis for 3 months
16036145|NCT02623218|Device|Acupuncture|An acupuncture needle is a device intended to pierce the skin in the practice of acupuncture. The device consists of a solid, stainless steel needle. The device may have a handle attached to the needle to facilitate the delivery of acupuncture treatment.
16036146|NCT02623218|Device|Sham Acupuncture|Sham acupuncture will be performed at the same locations as verum acupuncture. Streitberger sham acupuncture needles look like real acupuncture needles, and appear as though the skin is being penetrated during the insertion technique, however they do not pierce the skin.
16036147|NCT02623205|Drug|Escitalopram|Participants randomized to the escitalopram group will be given the medication for 8 weeks, after which they will be given the option to continue for 4 more weeks if they are close to remission.
16036148|NCT02623205|Drug|Placebo|To reduce the burden of the patients on placebo, the placebo trial will have a target of 8 weeks. To provide an opportunity for placebo non-responders to receive active drug and to aid in recruitment, we will provide 8-12 weeks of SSRI treatment to placebo non-responders.
16036149|NCT02623192|Other|Patients who have performed the ARDS pulmonary function test|
16036150|NCT02623179|Other|culture versus Molecular diagnostics|Treatment based on the results of the FH C & S testing - Odd Numbers on randomization table
16036151|NCT02623153|Drug|Oxaliplatin|oxaliplatin 130 mg/m2
16036152|NCT02623153|Drug|capecitabine|capecitabine of 1000 mg/m2
16036153|NCT02623153|Drug|S1|S1 of 40 mg/m2
16036154|NCT02623153|Drug|Docetaxel|docetaxel 40 mg/m2
16036155|NCT02623140|Device|Biofreedom|PCI with Biofreedom stent
16036156|NCT02623140|Device|Orsiro|PCI with Orsiro stent
16036157|NCT02623127|Drug|Sunitinib|
16036158|NCT02623114|Drug|methylphenidate|The patients received a fixed dose of medication for 2 weeks. The dose was increased according to the clinician's judgment. The patients came to the hospital at week 2,4,6,8,16,24wks, 9, 12,15,18,21,24 months
16036159|NCT02623114|Drug|atomoxetine|The patients received a fixed dose of medication for 2 weeks. The dose was increased according to the clinician's judgment. The patients came to the hospital at week 2,4,6,8,16,24wks, 9, 12,15,18,21,24 months
16036160|NCT02623101|Device|Reflectance confocal microscopy|Non-invasive imaging of the lesion
16036161|NCT02623101|Procedure|Punch biopsy|Obtaining a skin sample of the suspicious lesion under local anesthetics
16036162|NCT02623101|Procedure|Surgical excision|Excision of the basal cell carcinoma lesion under local anesthetics
16036163|NCT02623088|Other|PAP Therapies (CPAP)|Patients with sleep apnea syndrome treated by PAP Therapies (CPAP) after diagnosis and followed 5-7 years.
16036164|NCT02623075|Biological|Influenza vaccine|Blood samples will be collected at research study visits at 0 and 30 days (+/- 2 days) post-IIV4 (influenza vaccine). Collection will be as follows: 45-50 ml blood at each visit (not to exceed more than three visits over a two month period).
16036165|NCT02623062|Drug|Compound Sodium Alginate Oral Suspension sachet|Contents of 2 sachets taken four times daily for 7 days
16036166|NCT02623062|Drug|Matched placebo|Contents of 2 sachets taken four times daily for 7 days
16036167|NCT02623049|Other|New oral anticoagulant pharmacodynamic analysis (blood level assesment)|
16036168|NCT02623036|Drug|Equivalent dose enalapril|Chronotherapy with enalapril.
16036169|NCT02623036|Drug|Equivalent dose lisinopril|Chronotherapy with lisinopril
16036170|NCT02623023|Drug|Combigan|brimonidine/timolol fixed combination (Combigan®, Allergan; Dublin, IRL)
16036171|NCT02623023|Other|Refresh tears|This is a placebo group. Refresh tears®, Allergan; Dublin, IRL, is a lubricant eye drop that keeps they eye hydrated
16036172|NCT02623010|Drug|Imbruvica|Bruton's Tyrosine Kinase Inhibitor Ibrutinib as maintenance treatment in elderly patients with primary CNS lymphoma following first line chemotherapy treatment
16036173|NCT02622997|Other|Refrigerated|Self-sample taken and refrigerated immediately then stored in laboratory at -20oC until testing
16036174|NCT02622997|Other|Incubated at 25oC for 1 week|Self-sample taken and refrigerated immediately then incubated at 25oC for 1 week in laboratory then at -20oC until testing
16036175|NCT02622997|Other|Incubated at 25oC for 2 weeks|Self-sample taken and refrigerated immediately then incubated at 25oC for 2 weeks in laboratory then at -20oC until testing
16036176|NCT02622984|Behavioral|RBIRT|Intervention group will receive the telehealth or remote behavior intervention and referral for substance use (RBIRT). Other group will receive treatment as usual which is SBIRT.
16036177|NCT02622984|Behavioral|SBIRT|"Face to face standard intervention considered treatment as usual."
16036178|NCT02622971|Other|PBMT|Effects of phototherapy isolated and/or combined with cryotherapy in post-exercise skeletal muscle recovery.
16038338|NCT02607644|Device|Laryngeal Mask Airway (LMA)|Laryngeal Mask Airway (LMA) for Control group
16036179|NCT02622971|Other|Cryotherapy|Effects of cryotherapy isolated and/or combined with phototherapy in post-exercise skeletal muscle recovery.
16036180|NCT02622958|Drug|PH94B|"PH94B is self-administered intranasally as needed or as necessary, no more than four doses per day for male and female subjects. Each spray delivers 50 µL (0.8 µg PH94B).
~Dosing is sex-specific:
~Males: two (2) sprays (100 µL) are to be administered to each nostril, for a total dose of 3.2 µg
~Females: one (1) spray (50 µL) is to be administered to each nostril, for a total dose of 1.6 µg"
16036181|NCT02622958|Other|Placebo|"Placebo is self-administered intranasally as needed or as necessary, no more than four doses per day for male and female subjects. Each spray delivers 50 µL (0.8 µg Placebo).
~Dosing is sex-specific:
~Males: two (2) sprays (100 µL) are to be administered to each nostril, for a total dose of 3.2 µg
~Females: one (1) spray (50 µL) is to be administered to each nostril, for a total dose of 1.6 µg"
16036182|NCT02622945|Device|Active tDCS plus Speech-Language Therapy|Stimulation will be delivered by a battery-driven constant current stimulator. The electrical current will be administered to a pre-specified region of the brain not affected by the lesion(perilesional areas, right hemisphere or cerebellum). The stimulation will be delivered at an intensity of 2mA (estimated current density 0.04 mA/cm2; estimated total charge 0.048C/cm2) in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy will be oral and written naming.
16036183|NCT02622945|Device|Sham plus Speech-Language Therapy|Speech-Language therapy will be administered during sham stimulation. Current will be administered in a ramp-line fashion but after the ramping the intensity will drop to 0 mA. Speech-language therapy will be oral and written naming.
16036184|NCT02622932|Drug|Anlotinib and 14C-labeled Anlotinib|oral
16036185|NCT02622906|Drug|Pasireotide|60 mg per month of the Pasireotide during 6 months
16036186|NCT02622906|Drug|Placebo|Vehicule injection per month during 6 months
16036187|NCT02622893|Drug|Transperitoneal laparoscopic nephrectomy|After the surgery: 10 ml 0.25% bupivacaine through epidural catheters before extubation and continuous infusion of 0,1% bupivacaine and 1 µg/ml fentanyl 5 ml/h with patient-controlled boluses of an additional 4 ml, with a lockout time of 20 min and 4-h limit of 30 ml by a patient controlled epidural analgesia (PCEA) device
16036188|NCT02622893|Drug|Retroperitoneal laparoscopic nephrectomy|After the surgery: 10 ml 0.25% bupivacaine through epidural catheters before extubation and continuous infusion of 0,1% bupivacaine and 1 µg/ml fentanyl 5 ml/h with patient-controlled boluses of an additional 4 ml, with a lockout time of 20 min and 4-h limit of 30 ml by a patient controlled epidural analgesia (PCEA) device
16036189|NCT02622880|Dietary Supplement|immunomodulatory supplement|Experimental Group (immunomodulatory supplement STUDY)
16036190|NCT02622880|Dietary Supplement|IMPACT|IMPACT (Nestle Healthcare Nutrition, Minnesota USA) an 'immune-enhancing' feed which contains supplemental L-arginine (1.25 78 g/L), dietary nucleotides (1.2 g/L) and omega-3 fatty acids in the form of 79 eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (EPA/DHA 1.7 g/L) 80 as its active ingredients.
16036191|NCT02622867|Other|Lactobacillus plantarum 3547|During one period of parallel study (12 weeks) volunteers consumed 1 capsule/daily with Lactobacillus plantarum 3547 immediately after finishing their meal.
16036192|NCT02622867|Dietary Supplement|Maltodextrin|During one period of parallel study (12 weeks), volunteers will consume 1 daily capsule of maltodextrin immediately after finishing their meal.
16036193|NCT02622854|Procedure|plasma exchange|see arm description
16036194|NCT02622854|Drug|conservative treatment|see arm description
16036195|NCT02622841|Procedure|BLEND|Stereotactic bodyradiotherapy and surgical stabilization within 48 hours.
16036196|NCT02622828|Behavioral|Participant-identified community based activity|The Canadian Occupational Performance Measure (COPM) is a client-centered outcome measure designed to detect changes in performance and satisfaction in occupations that the individual has self-identified as being important and difficult to perform. The COPM will be used to set self-identified, community-based activities as treatment goals.
16036197|NCT02622802|Drug|paracetamol|In an ex vivo placenta perfusion study, placental tissue is exposed to paracetamol
16036198|NCT02622802|Drug|Erythromycin|In an ex vivo placenta perfusion study, placental tissue is exposed to erythromycin
16036199|NCT02622802|Drug|Azithromycin|In an ex vivo placenta perfusion study, placental tissue is exposed to azithromycin
16036200|NCT02622789|Other|Pilates Exercises|Pilates method based stability exercise intervention
16036201|NCT02622776|Other|Vaginal DNA Collection|Vaginal self-swab, 6hr tampon collection and response to an acceptability questionnaire
16036202|NCT02622763|Biological|Tolerogenic Dendritic Cells|Intralesional administration
16036203|NCT02622750|Procedure|triple-branched stent graft|place the triple-branched stent graft into the aortic arch, descending aorta ,the left subclavian artery, the left common carotid artery, and the innominate artery.
16036204|NCT02622750|Procedure|four-branched Dacron graft|"The stent elephant trunk was inserted into the true lumen of the distal aorta in a bound, compressed state after the distal aorta was transected between the origin of the left subclavian artery and the left carotid artery. The distal aorta incorporating the stent graft was firmly attached to the distal end of the four-branched Dacron graft using the open aortic procedure. After the anastomosis was completed, blood perfusion of the lower body was started via the perfusion limb of the four-branched Dacron graft."
16036205|NCT02622737|Other|Functional training|Three times per week, with 50 minutes per session, during 8 weeks of training activities involving 10 minutes of muscle stretching, 5 minutes of warm-up exercise, 30 minutes of a functional training and 5 minutes of respiratory exercises.
16036206|NCT02622737|Device|Stationary bike|Three times per week, with 50 minutes per session, during 8 weeks of training activities involving 10 minutes of muscle stretching, 5 minutes of warm-up exercise, 30 minutes of a Stationary Bike exercise and 5 minutes of respiratory exercises.
16036207|NCT02622737|Device|Exergaming|Three times per week, with 50 minutes per session, during 8 weeks of training activities involving 10 minutes of muscle stretching, 5 minutes of warm-up exercise, 30 minutes of a Virtual Reality exercise (performed by Xbox360 with KinectTM sensor) and 5 minutes of respiratory exercises.
16036208|NCT02622724|Drug|Interferon beta-1a|Investigational drug
16036209|NCT02622724|Drug|Placebo|Placebo for investigational drug
16036210|NCT02622711|Behavioral|DI|Participants will be offered an individualized dietary counselling according to their lifestyle habits to reduce weight consisting of face-to face contacts, group meetings, motivational phone calls and information pamphlets.
16036211|NCT02622711|Behavioral|PAI|Participants will be offered an individualized physical activity counseling according to their lifestyle habits to reduce weight consisting of face-to face contacts, group meetings, motivational phone calls and information pamphlets.
16036212|NCT02622711|Behavioral|PADI|Participants will be offered an individualized dietary and physical activity counseling to reduce weight consisting of face-to face contacts, group meetings, motivational phone calls and information pamphlets.
16036213|NCT02622711|Behavioral|LII|Participants will be considered as control group. They will receive a general healthy counselling providing materials and guidelines available for the general public.
16036214|NCT02622698|Dietary Supplement|Prostat AWC|Prostat AWC- patients received protein supplementation after surgery
16036215|NCT02622698|Other|Placebo|Placebo- Patients did not take any protein supplementation after surgery
16036216|NCT02622685|Drug|DWP10292|Drug: DWP10292 tablets, oral administration, multiple administration
16036217|NCT02622685|Drug|DWP10292 Placebo|Placebo tablets, oral administration, multiple administrations
16036218|NCT02622685|Drug|Ursodeoxycholic acid (UDCA)|Drug: Ursodeoxycholic acid (UDCA) tablets, oral administration, multiple administration
16036219|NCT02622685|Drug|UDCA Placebo|Placebo tablets, oral administration, multiple administrations
16036220|NCT02622672|Dietary Supplement|water-soluble ubiquinol|100 mg/d
16036221|NCT02622672|Dietary Supplement|Placebo|glycerin.soy-lecithin, and water
16036222|NCT02622659|Drug|Fuganlin Oral Liquid|"less than 1 years old: 5mL each time and three times a day
~1~3 years old: 10mL each time and three times a day
~4~6 years old: 10mL each time and four times a day
~7~12 years old: 10mL each time and five times a day"
16036223|NCT02622659|Drug|Xiaoer Jiebiao Oral Liquid|"1~2 years old: 5mL each time and twice a day
~3~5 years old: 5mL each time and three times a day
~6~14 years old: 10mL each time and twice a day"
16036224|NCT02622646|Drug|Recombinant VIII factor|"Identify and analyze cause(s) of poor bleeding control in patients on prophylaxis treatment and study the clinical impact of a personalized pilot program with a 1 year follow up to act on the specific causes.
~Describe PK parameters in patients on prophylaxis treatment with Advate®
~Analyze differences in PK parameters in non-controlled vs well controlled patients
~Identify causes of poor clinical outcome in non-controlled patients. Patients' individual variables that influence bleeding risk will be studied (individual PK, bleeding pattern, joint status, physical activity, life style and patient's adherence).
~Study the improvement in clinical outcomes (ABR and Joint status) of a 1 year Personalized Prophylaxis Program that acts specifically on the previously identified causes of bleeding in non-controlled patients (named: short half-life, high bleeding pattern, joint damage, high risk physical activity, active life style and poor patient's adherence)."
16036225|NCT02622633|Device|Epidural Electrode|Epidural electrode of high frequency (50Hz) stimulation in the dorsolateral prefrontal cortex.
16036226|NCT02622607|Drug|Zoledronic acid|Zoledronic acid 4 mg in 5 mL concentrated solution prepared with 100 mL calcium free infusion solution (0.9 % sodium chloride)
16036227|NCT02622594|Drug|Aminolevulinic Acid (ALA)|
16036228|NCT02622594|Device|Environ Cosmetic Roller|
16036229|NCT02622594|Device|BLU-U IIlluminator|
16036230|NCT02622581|Other|data collection|Baseline (demographic, clinical, tumor) characteristics, details on biomarker testing, including re-testing, treatment decision making, all systemic anticancer therapies including details, key data on radiotherapies, surgeries and specified supportive therapies, outcome (response, progression, survival), course of disease. Data will be documented at baseline and updated at least every three months.
16036231|NCT02622568|Drug|Veregen only|Topical application of Veregen 15% ointment on affected areas twice daily
16036232|NCT02622568|Procedure|Cryotherapy and Veregen|Cryotherapy followed by topical application of Veregen 15% ointment on affected areas twice daily
16036233|NCT02622555|Drug|Mirabegron|Patients with overactive bladder eligible for drug treatment who fulfill the EMA prescription guidelines receive mirabegron 50 mg extended release once daily according to clinical routine
16036234|NCT02622542|Device|BMT+TEVAR|These FDA-approved devices will be used for performing TEVAR in the patients randomized to this arm, in addition to the medical therapy to control blood pressure (BMT)
16036235|NCT02622542|Other|BMT|Optimal medical therapy will be administered to the patients randomized to this arm, involving but not limited to, beta-blockers, etc., to control the blood pressure and pain for stabilizing the patient upon presentation.
16036236|NCT02622529|Other|Screening through questionnaires|Distribution of Questionnaires to every participant within the single existent Arm at three times.
16036237|NCT02622516|Other|Intervention Group (IG)|"Therapeutic approaches to this proposal are intended to promote muscle relaxation to increase range of motion and analgesia of neck and shoulder girdle region, as well as the fascial release these regions with the intervention of cervical global pompage, exercises for body mobility for upper limb and trunk in the positions supine, lateral and dorsal, sitting and standing and gradually followed by proprioceptive exercises to the lower limbs and trunk in sitting and standing positions with aid devices such as foams, pool baguettes, balance boards, Swiss balls, steps, trampolines and BOSU ( BOSU® Home Balance Trainer ).
~The exercises will be held in individual treatments lasting sixty minutes with a frequency of once a week for all group members."
16036238|NCT02622516|Other|Control Group (CG)|"The exercises consist of eye movements in different directions, slow and fast; head movements in different planes, with open and closed eyes, slow and fast; and body exercises such as lifting and sit, walk open and closed eyes, up and down ramps and stairs, as well as some activities and ball games.
~The exercises will be held in individual treatments lasting sixty minutes with a frequency of once a week for all group members."
16036239|NCT02622503|Drug|Rituximab|This is an observational study. Patients with rheumatoid arthritis and having received treatment previously will be assessed for the treatment responses.
16036240|NCT02622490|Other|two test meals with two different macronutrient compositions|Either a high or a low carb meal either as one large or as 5 small meals. ie a crossover trial with one arm
16036241|NCT02622477|Drug|Pirfenidone|This is an observational study. Pirfenidone is available as an 267 mg capsule for oral administration.
16036242|NCT02622464|Other|micro injection of SVF in vocal cords|
16036303|NCT02622074|Drug|Carboplatin|AUC 6 or AUC5 administered Q3W as an IV infusion, or AUC2 administered weekly as an IV infusion, according to allocation.
16036304|NCT02622074|Drug|Paclitaxel|80 mg/m^2 or 70 mg/m^2 administered weekly as an IV infusion, according to allocation.
16036243|NCT02622451|Behavioral|Teen Intervene|Teen Intervene (TI) is an early intervention program for 12-19 year olds who display early stages of alcohol or drug use. TI uses motivational interviewing, goal setting, and skill training to foster the internal development of responsible decision-making with the goal of choosing attitudes and behaviors that are healthier alternatives to drug use behaviors.
16036244|NCT02622451|Behavioral|Everyday Parenting|Everyday Parenting is a family-focused intervention that works with parents to provide environmental scaffolding necessary to help teens gradually internalize decision-making skills that reinforce and promote healthy lifestyle alternatives.
16036245|NCT02622438|Other|Followed with an initial assessment, six months and followed annually for 3 years corresponding to the usual follow-up of the patient.|
16036246|NCT02622425|Dietary Supplement|Placebo|maltodextrin
16036247|NCT02622425|Dietary Supplement|PD01|Carotenoid-producing Bacillus strain PD01
16036248|NCT02622412|Other|Multi-professional breathlessness service (MBS)|Patients visit the MBS twice. At week 1, delivered by palliative care specialists and respiratory disease specialists, patients receive an detailed assessment of breathlessness, relevant symptoms beyond breathlessness, psychosocial issues and carer burden. Recommendations are provided, and reviewed at the concluding visit in week 6 with palliative care specialists. In between these visits, weekly physiotherapy sessions focus on positioning, breathing techniques, exercise as well as pacing and fatigue management. Further support from the multi-professional expert team is given as needed.
16036249|NCT02622412|Other|Delayed MBS Intervention|Patients will wait 8 weeks for start of intervention and will receive standard care in the meantime with access to respiratory medicine, general practitioners and palliative care services as needed. Standard care includes support by their general practitioners and disease orientated treatment (e.g. anti-obstructive treatment, oxygen supply if indicated, chemotherapy).
16036250|NCT02622399|Behavioral|Project NOW|This intervention aims to reduce social isolation and promote engagement in health promoting enrichment and activities, by embedding a community health worker-assisted forum in a community-driven mobile communications through a private, secure, and confidential platform supported by txtwire. The principal innovation is harnessing both the behavioral change utility of a mobile health application and the social support potential of an online social network the investigators can deliver more timely and dynamic reinforcement to caregivers and social support more in rhythm with the pace of community events and stressors.
16036251|NCT02622386|Drug|Riboflavin|Riboflavin (Vitamin B2) 400 mg capsule taken daily for 12 weeks.
16036252|NCT02622386|Other|Placebo|Matching placebo capsule taken daily for 12 weeks.
16036253|NCT02622373|Device|PEA POD Infant Body Composition System|The non-invasive device used in this study to measure a baby's body composition is a called a Pea Pod. The Pea Pod is a quick, safe, non-invasive and reliable bedside procedure used to measure changes in infant body composition.
16036254|NCT02622334|Drug|Latanoprost|Latanoprost is a ophthalmic solution, available in dose strength as 0.005%.
16036255|NCT02622334|Drug|Placebo|Matching placebo formulation will be administered in Part A.
16036256|NCT02622334|Drug|RO5093151|RO5093151 is a ophthalmic solution, available in dose strengths as 0.1%, 0.5% and 1%.
16036257|NCT02622321|Drug|Emicizumab|Emicizumab will be administered at a loading dose of 3 milligrams per kilogram per week (mg/kg/week) subcutaneously (SC) for the first 4 weeks followed by a maintenance dose of 1.5 mg/kg/week SC up to the end of study. After at least 24 weeks on prophylactic emicizumab, individuals who experience suboptimal bleeding control on emicizumab (according to protocol-defined criteria) will have the opportunity to increase their dose to 3 mg/kg weekly.
16036258|NCT02622321|Drug|rFVIIa|Participants will continue to receive rFVIIa.
16036259|NCT02622321|Drug|aPCC|Participants will continue to receive aPCC.
16036260|NCT02622308|Device|FlowOx™|FlowOx™ uses intermittent negative and atmospheric pressure, and is intended for use as an adjunct non-invasive therapy for the treatment of reduced peripheral circulation. Negative pressure cycles are created by alternating between removing air and venting the vacuum-chamber to atmospheric pressure. The vacuum cycle is controlled by the Control Unit (Pump). FlowOx™ is designed to assists wound healing indirectly by improving blood flow to the affected limb and augmenting the wound healing effect of the contact dressings and any associated medication. Treatment is planned to be applied while the participants are seated and it does not interfere with other activities normally enjoyed while seated. Treatment is recommended for one to two hours per session aiming to improve blood flow in the affected area and thus the clinical outcomes.
16036261|NCT02622295|Behavioral|Single-session high-frequency active-resisted stance|In a standing frame or standing wheelchair, the quadriceps and hamstrings will be electrically activated to elicit high muscle forces.
16036262|NCT02622295|Behavioral|Single-session low-frequency active-resisted stance|In a standing frame or standing wheelchair, the quadriceps and hamstrings will be electrically activated to elicit low muscle forces.
16036263|NCT02622295|Behavioral|High-frequency active-resisted stance training|In a standing frame or standing wheelchair, the quadriceps and hamstrings will be electrically activated to elicit high muscle forces. Subjects will train for 3 years.
16036264|NCT02622295|Behavioral|Low-frequency active-resisted stance training|In a standing frame or standing wheelchair, the quadriceps and hamstrings will be electrically activated to elicit low muscle forces. Subjects will train for 3 years.
16036265|NCT02622282|Other|Text Messages|Text messages will be sent one time per day. Text messages will include messages to motivate and inform participants on the importance of walking.
16036266|NCT02622282|Other|Phone Calls|Participants may receive a telephone call every two weeks for one month followed by once per month for two months.
16036267|NCT02622282|Other|Handout|Handout includes information specific to participant's condition and ways to promote an active lifestyle.
16036268|NCT02622269|Device|Patient-regulated compression device|Compression of the abdomen with a patient-regulated compression device
16036269|NCT02622269|Device|Standard compression device|Compression of the abdomen with the standard compression device
16036305|NCT02622048|Behavioral|Triple P Positive Parenting Programme|10 week self-directed (guided) parenting intervention promoting self-belief, parenting confidence/self-efficacy and problem solving skills.
16036306|NCT02622035|Behavioral|Provision of information|Information about fruit and vegetable feeding for children framed in gain vs. loss manner
16036307|NCT02622035|Behavioral|Emotion induction|Film clip designed to induce anger or fear
16036270|NCT02622256|Behavioral|Health System: HTN Intervention|Interested participants can enroll online via a Twitter link. Patients will consent to having their electronic health records accessed to validate clinical data. Participants will complete short surveys. The project Twitter account would follow tweeters with high impact CV messages and tweet daily high impact and accurate CV health messages (identified in aim 3). Participants will follow the study team & may receive daily private heart health messages via Twitter. This would allow participants to see CV health messages posted in the words and context of patients that may be similar to them, participate in online CV health discussions, and access CV health networks that they may not otherwise know about. Participants will also tweet heart health messages weekly.
16036271|NCT02622243|Drug|Tiotropium|long acting muscarinic antagonist
16036272|NCT02622243|Drug|glycopyrronium|long acting muscarinic antagonist
16036273|NCT02622243|Device|Respimat|inhaler device used to deliver active tiotropium or placebo
16036274|NCT02622243|Device|Breezehaler|inhaler device used to deliver active glycopyrronium or placebo
16036275|NCT02622230|Drug|Mianhuahua Flavonoids Tablets|"Tolerability Study:
~Period I:Single oral administration,dose-escalation of Mianhuahua Flavonoids Tablets(seven dose groups:0.3g-5.4g) Period II:Repeated oral administration of Mianhuahua Flavonoids Tablets (group 1:MTD（maximum tolerated dose）/1.5g, TID, group 2:depending on the adverse drug reaction,1.8g/1.2g, TID)
~Pharmacokinetic Study:
~Period I:Single oral administration,dose-escalation of Mianhuahua Flavonoids Tablets(six dose groups: 0.9g, 1.8g, 2.7g, 3.6g, 4.5g, 5.4g) Period II:Repeated oral administration of Mianhuahua Flavonoids Tablets (group 1:MTD（maximum tolerated dose）/1.5g, TID, group 2:depending on the adverse drug reaction,1.8g/1.2g, TID)"
16036276|NCT02622230|Drug|Placebo|Placebo to match with experimental groups
16036277|NCT02622217|Behavioral|Sleep deprivation|
16036278|NCT02622204|Procedure|Corrective osteotomy|corrective osteotomy for varus alignment
16036279|NCT02622191|Device|Spectral domain Optical Coherence Tomography|Undilated peripapillary circular optic nerve scans and horizontal and vertical SD-OCT B-scan images centered on the fovea were acquired using Spectralis Heidelberg Retinal Angiography (HRA)+OCT (Heidelberg Engineering GmbH, Heidelberg, Germany).
16036280|NCT02622178|Diagnostic Test|Optical Coherence Tomography|Optical coherence tomography (OCT) is a noninvasive imaging modality that provides micrometer-scale resolution.It has been revolutionized in recent years by exploitation of Fourier domain (FD) techniques, which have a significant sensitivity advantage over traditional time domain (TD) OCT. In spectral-domain (SD-OCT) the reference mirror is stationary, and OCT signal is acquired using a spectrometer as detector or by varying the wavelength of the light source.
16036281|NCT02622178|Diagnostic Test|Visual evoked potential|Visual evoked potential is a means of objectively testing visual field by viewing a computer monitor at 1 meter with a square black/white checkerboard pattern reversal stimulus. Electrodes are placed on the head and face to monitor Electroencephalogram (EEG) activity during testing. Output parameters from VEP system include amplitude and latency measures for each stimuli.
16036282|NCT02622165|Behavioral|The REWARD serious game intervention|The REWARD intervention is based on the dual process model incorporating strategies to influence both the automatic pathway (i.e., operant learning theory) and the conscious pathway (i.e., a focus on certain determinants). The central idea of the intervention will be that participants will earn credits in the game when scanning healthy (rather than unhealthy) snacks which will influence the advancement of the players in the game. This credit system will be related to the dietary quality index of the consumed snacks.
16036283|NCT02622152|Procedure|Right lateral position (2 hours)|Repositioning the patients for two-hours period on the right lateral position
16036284|NCT02622152|Procedure|Left lateral position (30 minutes)|Repositioning the patients for 30 minutes period on the left lateral position
16036285|NCT02622152|Procedure|Supine position (30 minutes)|Repositioning the patients for 30 minutes period on the supine position
16036286|NCT02622152|Procedure|Left lateral position (2 hours)|Repositioning the patients for two-hours period on the left lateral position
16036287|NCT02622152|Procedure|Supine position (2 hours)|Repositioning the patients for two-hours period on supine position
16036288|NCT02622139|Device|Multispectral Optoacoustic Tomography (MSOT)|MSOT for the evaluation of disease activity in IBD patients
16036289|NCT02622126|Drug|hydroxyethyl starch (6% 130/0.4)|preloaded prior to spinal anesthesia with 500 mL hydroxyethyl starch (6%130/0.4) (Voluven).
16036290|NCT02622126|Drug|Hyperbaric bupivacaine|Sub arachnoid 10-12 mg hyperbaric bupivacaine
16036291|NCT02622126|Drug|Morphine|Sub arachnoid 200 meg morphine
16036292|NCT02622126|Drug|Isotonic 0.9 sodium chloride (NaCl) solution|10 ml/kg of isotonic 0.9 sodium chloride (NaCl) solutions will be used as co loading during the duration of the operation
16036293|NCT02622126|Drug|Ephedrine|If severe hypotension (fall of > 20% of mean arterial pressure from baseline) occurred, vasopressors, 6 mg ephedrine (per dose) will be used.
16036294|NCT02622126|Drug|Atropine|Bradycardia (fall of >30% of heart rate from baseline or <50 beats /minute and when associated with hypotension) will treated with 0.5 mg of atropine intravenous.
16036295|NCT02622113|Drug|Canagliflozin (TA-7284)|The patients will receive Canagliflozin orally for 36 weeks
16036296|NCT02622113|Drug|Insulin|
16036297|NCT02622100|Device|Bioresorbable Vascular Scaffold|
16036298|NCT02622087|Behavioral|One-Session-Treatment|There are a total of five steps, each to be repeated until the participant experiences a reduction of at least 50% in their anxiety. Step 1 is catching a spider with a glass and postcard. Step 2 is touching a spider from behind with the dominant index finger. Step 3 is letting a spider walk on the participant's hands. Step 4 is allowing a spider to walk on the participant's legs and body. Steps 1-4 are repeated with larger spiders, and then the two biggest spiders will walk on the participants' hands simultaneously. Step 5 is using a chopstick to guide a huntsman spider over their gloved hand. Treatment ends when all steps are completed, or if the maximum 3 hour time limit has been reached, or if the participant indicates that they do not want to continue.
16036299|NCT02622074|Biological|Pembrolizumab|200 mg administered Q3W as an IV infusion.
16036300|NCT02622074|Drug|Nab-paclitaxel|125 mg/m^2 or 100 mg/m^2 administered weekly as an IV infusion, according to allocation.
16036301|NCT02622074|Drug|Anthracycline (doxorubicin)|60 mg/m^2 administered Q3W as an IV injection.
16036302|NCT02622074|Drug|Cyclophosphamide|600 mg/m^2 administered Q3W as an IV infusion.
16038836|NCT02604212|Drug|ARC-520|
16038837|NCT02604212|Other|Placebo|
16036308|NCT02622035|Behavioral|visual perceptual load|visual and interactivity-based load of virtual reality buffet environment
16036309|NCT02622022|Drug|Morphine hydrochloride|
16036310|NCT02622022|Other|Placebo|
16036311|NCT02622009|Procedure|BRONCHOSCOPIC PROCEDURE|After the routine bronchoscopic inspection of the tracheobronchial tree, the investigators performed BAL from subsegmental bronchi and bronchial biopsies (3-4 per patient) from non infiltrated carina
16036312|NCT02621996|Device|hammock|PN who will be positioned in hammock inside the incubator will be with the high trunk to about the 30th, and will be used a roll of restraint in the neck by keeping a slight lordosis to avoid suffocation risks. In two days of placement, should remain about 8 hours in the hammock, being removed during cleaning procedures, diet and medical evaluation and then immediately replaced in the hammock. The alternation of decubitus (right side, supine and left lateral) should be performed whenever the child is manipulated for these procedures.
16036313|NCT02621996|Device|containment nest|"In the control group, the position will follow the routine procedure of the Hospital Barão de Lucena, consisting of the use of restraint nests U, made with rolled sheet placed on the mattress of the incubator and covered by another sheet. The control group incubators will also be inclined at 30 ° as routine service. During the 8 position, switching the supine will also be held, side left and side right after the baby handling to cleaning procedures, diet and medical evaluation."
16036314|NCT02621983|Behavioral|Aerobic Exercise|Subjects with a diagnosis of SCZ will complete aerobic exercises consisting of spin classes 3 times a week on a stationary bicycle ergometer. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.
16036315|NCT02621983|Behavioral|Balance and Stretching|Subjects with a diagnosis of SCZ will complete a balance and stretching program consisting of progressive whole body stretching and toning exercises. Exercise time will progress from an initial 20 minutes per session to a maximum of 45 minutes by increasing 5 minutes each week for 12 weeks.
16036316|NCT02621970|Drug|Cisplatin 1|Cisplatin 25 mg/m2, D1-3
16036317|NCT02621970|Drug|Cisplatin 2|Cisplatin 100 mg/m2, D1
16036318|NCT02621970|Drug|Docetaxel|Docetaxel 60mg/m2, D1
16036319|NCT02621970|Drug|Xeloda|Xeloda 2000mg/m2, D1-14 in concurrent chemotherapy and Xeloda 2500mg/m2, D1-14 in adjuvant chemotherapy
16036320|NCT02621970|Radiation|Intensity-modulated radiotherapy|Intensity-modulated radiotherapy
16036321|NCT02621957|Drug|GDC-0810|During Period 2 subjects will be administered an oral 600 mg dose GDC-0810 daily beginning on Day 5 for 4 consecutive days (from Days 5 to 8, inclusive).
16036322|NCT02621957|Drug|Pravastatin|Subjects will receive a single oral dose of 10 mg pravastatin on Day 1 in Period 1 and Day 7 in Period 2.
16036323|NCT02621944|Drug|Melatonin|Participants 1-10 will receive a 0.5 mg/kg enteral dose of Melatonin. Participants 11-20 will receive Melatonin dose of 3 mg/kg enteral. Participants 21-30 will receive Melatonin dose of 5 mg/kg enterally.
16036324|NCT02621944|Other|Magnetic Resonance Imaging|All participants will receive an MRI between 7-12 days of age.
16036325|NCT02621944|Other|Pharmacokinetics|All participants will receive pharmacokinetics to test the amount of melatonin in the blood.
16036326|NCT02621944|Behavioral|Neurological Outcome Assessment|All participants will receive the Bayley-III Scores and Subsets for neurological outcome assessments.
16036327|NCT02621931|Drug|Fremanezumab|Fremanezumab was provided as a sterile, unpreserved, aqueous solution for injection, 225 mg/1.5 mL pre-filled syringe for single-use administration. The 675 mg dose was given as 3 injections; doses of 225 mg were given as a single injection. Study drug was administered at the clinical site.
16036328|NCT02621931|Drug|Placebo|Placebo 1.5 mL pre-filled syringes identical in appearance to active intervention. Study drug was administered at the clinical site.
16036329|NCT02621918|Other|Progressive resistance training|
16036330|NCT02621918|Other|Aerobic training|
16036331|NCT02621918|Other|Placebo training|
16036332|NCT02621905|Drug|Sporanox|At least 2 capsules twice a day for 3 weeks
16036333|NCT02621905|Drug|Lozanoc|At least 2 capsules twice a day for 3 weeks
16036334|NCT02621892|Drug|Tenapanor|
16036335|NCT02621892|Drug|Placebo|
16036336|NCT02621879|Procedure|Bilateral Gluteal Advancement Flap|Dissection of both gluteus maximus muscles from their origin in the sacrum, advancement of both muscles is conducted to the midline after creating release incisions in their fascia.
16036337|NCT02621866|Device|Ultraviolet A radiation|Twice daily with 10 Joules/cm2. Half body (one side) with Waldmann 100L phototherapy lamp fitted with UVA bulbs (main emission 320-410nm)
16036338|NCT02621866|Device|Sham irradiation|As active, but lamps to be shielded with Amber 81 museum film which prevents transmission of <500nm, but permits visible light to pass.
16036339|NCT02621853|Device|Raman spectroscopy of the liver|Liver will be illuminated by the Raman spectroscope optic probe in order to assess fat content
16036340|NCT02621840|Behavioral|Mandatory On-Site Pre-Admission Testing|
16036341|NCT02621827|Other|Oral dose of stable isotope labeled 25(OH)D3|At each measurement, women are given an oral dose of stable isotope labelled 25(OH)D3. Blood and urine samples are collected at baseline and on day 21 post-dose. Additional blood samples are collected post-dose on days 6,9,24,27 and 30.
16036342|NCT02621814|Dietary Supplement|Low glycation formula feeding|Formula feeding on demand for 3 months
16036343|NCT02621814|Dietary Supplement|Commercially common formula feeding|Formula feeding on demand for 3 months
16036344|NCT02621801|Behavioral|Stress Management and Resiliency Training for Residents (SMART-R)|The Stress Management and Resiliency Training Program for residents (SMART-R) is a six-hour intervention delivered over 2 or 3 sessions that teaches residents mind-body skills to reduce stress and enhance coping strategies.
16036345|NCT02621788|Behavioral|Stress Management and Resiliency Training for Residents (SMART-R)|The SMART-R is a mind-body Educational Program for residents that is aimed at reducing the impact of stress and enhancing coping strategies through skill building exercises. The intervention consists of 3, 2 hour sessions over the course of 12 months.
16036420|NCT02621333|Biological|CIK|platinum combined doublets: Paclitaxel 175mg/m2 D1, or Docetaxel75mg/m2 D1, or Pemetrexed Disodium 500mg/m2，D1；combined cisplatin 25mg/m2，D1-3 or carboplatin AUC=5, D1. After 3 or 4 days of chemotherapy, about 5×109 autologous cytokine-induced killer cells are transfused into the vein of patients in one hour.
16039435|NCT02600130|Biological|Placebo|via peripheral intravenous infusion
16036346|NCT02621775|Behavioral|Computer-based stress management program|The program includes 5 one hour weekly sessions that patient follow from a web site accessible from a computer in our unit. He benefits from a minimal contact with a medical member of staff before and after every session. The duration of each session is about one hour. To avoid internet connexion problem between session it is supplied to the patient, from the first session an USB key (Universal Serial Bus) containing videos, audio files, self help book, portfolio in the form of e-guide, log book with the program of the exercises to be realized between two session of the five sessions program. The patient is encouraged to practice a twenty-minutes daily exercises five or six days per week.
16036347|NCT02621775|Behavioral|Stress management in face-to-face|The program includes 5 forty-five minutes weekly session with a therapist (psychologist graduate of a master of cognitive and emotional therapy with a minimal of one year of practice in CBT and CBSM (Cognitive-Behavioral Stress Management ). Information, exercises and homework assignments are delivered by the therapist without self help support.
16036348|NCT02621775|Other|Waiting list|The patients are followed by their General Practitioners without change in treatment .
16036349|NCT02621762|Device|Magnesium|Magnesium in dialysate increased
16036350|NCT02621762|Device|Bicarbonate|Bicarbonate in dialysate increased
16036351|NCT02621749|Device|Renal replacement therapy|Patients receive renal replacement therapy according to institutional standards
16036352|NCT02621736|Other|blood sampling|At 4 visits capillary blood sampling for copeptin measurement will be performed with each child.
16036353|NCT02621710|Other|Questionnaire 3 months post-operatively|
16036354|NCT02621697|Other|Cognitive motor training|Initially an intervention consisting of double duty activities (motor-cognitive) and the control group will be subjected to a conventional treatment based on stretching and strengthening will be held.
16036355|NCT02621697|Other|kinesiotherapeutic conventional treatment|Standardized global stretching and strengthening with squat exercise, plantar flexion in foot and elbow flexion supporting body weight in the hands arranged on the wall
16036356|NCT02621684|Other|Community Health Activities Model Program for Seniors (CHAMPS)|"Physical activity questionnaire for older adults
~Asks about activities in the past 4 weeks
~41 questions and asks to notate how long the activity took"
16036357|NCT02621684|Other|Lifetime Total Physical Activity Questionnaire|"Questions about leisure time (27) and household activities (5)
~Mark if participated in the activity during the past year, ages 51-65, 35-50, 23-34, and onset of puberty through 21 years"
16036358|NCT02621684|Other|Expanded Prostate Cancer Index Composite (EPIC)|"Measures urinary and sexual function before and after prostate cancer treatment
~7 questions about urinary function
~9 questions about sexual function"
16036359|NCT02621684|Other|International Physical Activity Prevalence Study Environmental Module|-The 17-item Physical Activity Neighborhood Environment Scale can be used to assess the environmental factors for walking and bicycling in various neighborhoods.
16036360|NCT02621684|Other|Godin Leisure-Time Exercise Questionnaire (GLTEQ)|-4 item query of usual leisure time exercise habits
16036361|NCT02621684|Other|Questionnaire regarding behavior/lifestyle changes since diagnosis|
16036362|NCT02621684|Other|12 week Walking Program|
16036363|NCT02621684|Other|12 week Resistance Training Program|
16036364|NCT02621671|Behavioral|Cognitive interview|
16036365|NCT02621671|Other|Survey|
16036366|NCT02621658|Other|Clear Liquid Diet|Patients will be allowed to consume clear soft drinks like ginger ales, Sprite®, 7-Up®, Gatorade®, Kool Aid®. They can also have strained fruit juices like apple, white grape juice and lemonade, and water, tea and coffee without milk or non-dairy creamer. Patient in this arm will also be allowed to have low-sodium chicken or beef broth , in addition to non-red hard candies, Jell-O®, and popsicles.
16036367|NCT02621658|Other|Full Liquid Diet|Patients will be allowed to consume a Full Liquid Diet, including nutritional supplements(Ensure®, Boost®, Glucerna®), strained cereals(like cream of wheat or strained oatmeal) and vegetables, purred fruit without seeds or pulp, milk, plain ice cream or yogurt, sherbet, coffee with cream, and tea.
16036368|NCT02621645|Procedure|Early selective reduction of TRAP mass|Ultrasound-guided intrafetal ablation using an 18 Gauge to 20 Gauge needle
16036369|NCT02621645|Procedure|Late selective reduction of TRAP mass|Ultrasound-guided intrafetal ablation using a 17 Gauge to 20 Gauge needle OR fetoscopic laser coagulation of the cord or anastomising vessels through a 17 Gauge to 7 French trocar, with a 1-1,3 mm fetoscope and a 400 µm laser fiber. The treating physician can decide which technique will be used for the selective reduction.
16036370|NCT02621645|Device|Ultrasound-guided intrafetal ablation using a 18 to 20 Gauge needle|
16036371|NCT02621645|Device|Ultrasound-guided intrafetal ablation using a 17 to 20 Gauge needle|
16036372|NCT02621645|Device|Laser coagulation of the cord or anastomising vessels through a 17 Gauge to 7 French trocar, with a 1-1,3 mm fetoscope and a 400 µm laser fiber|
16036373|NCT02621632|Device|(Socknleg)To done of a novel compression system|To done a novel compression system.
16036374|NCT02621619|Drug|IV acetaminophen + 0.5 mg IV hydromorphone|1 gram (100 ml) IV acetaminophen in addition to 0.5 mg IV hydromorphone
16036375|NCT02621619|Drug|Normal saline + 0.5 mg IV hydromorphone|100 cc normal saline placebo in addition to 0.5 mg IV hydromorphone
16036376|NCT02621606|Drug|[11C]MK-6884|IV bolus dose of ~370 MBq [11C]MK-6884
16036377|NCT02621593|Device|M22-IPL|The IPL hand piece operates at a spectrum of 400-1200nm with 7 different filters that can be easily inserted to the hand piece to treat different conditions. The IPL hand piece also includes 2 different sapphire cooled light guides of 8x15mm and 15x35mm. The cut-off filters that will be used for this evaluation are filters blocking wavelengths of 560 and 595 nm.
16036378|NCT02621580|Device|Pan-Retinal Photocoagulation|"Diabetic retinopathy does not usually impair sight until the development of long-term complications, including proliferative retinopathy, a condition in which abnormal new blood vessels may rupture and bleed inside the eye. When this advanced stage of retinopathy occurs, pan-retinal photocoagulation is usually recommended.
~During this procedure, a special laser is used to make tiny burns that seal the retina and stop vessels from growing and leaking. Hundreds of tiny spots of laser are placed in the retina to reduce the risk of vitreous haemorrhage and retinal detachment."
16036421|NCT02621333|Drug|chemotherapy|platinum combined doublets: Paclitaxel 175mg/m2 D1, or Docetaxel75mg/m2 D1, or Pemetrexed Disodium 500mg/m2，D1；combined cisplatin 25mg/m2，D1-3 or carboplatin AUC=5, D1.
16036379|NCT02621567|Device|Bright Light Therapy Lamp|TRAVelite Desk Lamp manufactured by Northern Light Technologies, located in Montreal, Quebec. The light is emitted from a lamp. The florescent tubes in the box are covered with a diffusing screen to ensure even distribution of light and protection from ultraviolet light. These lamps also have a stand which enables users to place the box horizontally or vertically on most surfaces. These lamps emit light of intensity 10,000 lux.
16036380|NCT02621567|Device|Modified Dim Lamp|TRAVelite Desk Lamp manufactured by Northern Light Technologies, located in Montreal, Quebec. The light is emitted from a lamp. The florescent tubes in the box are covered with a diffusing screen to ensure even distribution of light and protection from ultraviolet light. These lamps also have a stand which enables users to place the box horizontally or vertically on most surfaces. These lamps have been modified to emit light of intensity 500 lux.
16036381|NCT02621554|Dietary Supplement|resveratrol supplementation|6 months of resveratrol supplementation
16036382|NCT02621554|Dietary Supplement|Placebo|6 months of placebo intake
16036383|NCT02621541|Device|PET/CT|
16036384|NCT02621528|Device|CeraFlex|The Lifetech CeraFlex™ study is a triple-arm study.
16036385|NCT02621515|Drug|Nivolumab|All patients in this phase 2 trial will receive treatment with nivolumab, a monoclonal antibody against the PD1-receptor on T cells. Dosing will be based on patients' weight (3 mg/kg). It will be administered in an intravenous infusion every 2 weeks and for a maximum of 2 years.
16036386|NCT02621502|Dietary Supplement|Quinoa variety 1|"On the intervention day, the volunteers will consume the Quinoa Variety 1.
~Then during minutes 0, 15, 30, 45, 60, 90, 120, 180, 240 and 260 two types of methodologies were conducted:
~In minutes 0, 15, 30, 45, 60, 90 and 120, blood samples were collected.
~In minutes 0, 15, 30, 60, 90, 120, 180, 240 and 260, volunteers completed the Visual analogue scale questionnaire."
16036387|NCT02621502|Dietary Supplement|Quinoa variety 2|"On the intervention day, the volunteers will consume the Quinoa Variety 2.
~Then during minutes 0, 15, 30, 45, 60, 90, 120, 180, 240 and 260 two types of methodologies were conducted:
~In minutes 0, 15, 30, 45, 60, 90 and 120, blood samples were collected.
~In minutes 0, 15, 30, 60, 90, 120, 180, 240 and 260, volunteers completed the Visual analogue scale questionnaire."
16036388|NCT02621502|Dietary Supplement|Quinoa variety 3|"On the intervention day, the volunteers will consume the Quinoa Variety 3.
~Then during minutes 0, 15, 30, 45, 60, 90, 120, 180, 240 and 260 two types of methodologies were conducted:
~In minutes 0, 15, 30, 45, 60, 90 and 120, blood samples were collected.
~In minutes 0, 15, 30, 60, 90, 120, 180, 240 and 260, volunteers completed the Visual analogue scale questionnaire."
16036389|NCT02621502|Dietary Supplement|Quinoa variety 4|"On the intervention day, the volunteers will consume the Quinoa Variety 4.
~Then during minutes 0, 15, 30, 45, 60, 90, 120, 180, 240 and 260 two types of methodologies were conducted:
~In minutes 0, 15, 30, 45, 60, 90 and 120, blood samples were collected.
~In minutes 0, 15, 30, 60, 90, 120, 180, 240 and 260, volunteers completed the Visual analogue scale questionnaire."
16036390|NCT02621502|Dietary Supplement|Anhydrous Glucose|"On the intervention day, the volunteers will consume the control product.
~Then during minutes 0, 15, 30, 45, 60, 90, 120, 180, 240 and 260 two types of methodologies were conducted:
~In minutes 0, 15, 30, 45, 60, 90 and 120, blood samples were collected.
~In minutes 0, 15, 30, 60, 90, 120, 180, 240 and 260, volunteers completed the Visual analogue scale questionnaire."
16036391|NCT02621489|Drug|Bydureon|2 mg Once Weekly
16036392|NCT02621489|Drug|Humulin kwickpen|Humulin kwickpen 10U QD at bedtime
16036393|NCT02621489|Drug|Metformin|Metformin 1g BID
16036394|NCT02621476|Behavioral|Standardized intervention|Standardized intervention to encourage mail order use and provide easily accessible information on how to access the service
16036395|NCT02621476|Behavioral|Usual care|Usual care
16036396|NCT02621463|Device|Noninvasive Ventilator (V60, Philips)|The clinician will determine the concentration of oxygen that shall be delivered to the patient. The ventilator is capable of providing concentrations between 21% - 100% of oxygen. Unless otherwise directed by the clinician, the default setting of 40% will be used.
16036397|NCT02621450|Biological|standart dialysis|dialysate sodium consentration 140 mEq
16036398|NCT02621450|Biological|low sodium dialysis|dialysate sodium consentration will be reducer from 140 mEq to 137 mEq
16036399|NCT02621437|Other|Osteopathy sessions|- Three osteopathy sessions every 14 days (D13, D27 and D41 post-surgery),
16036400|NCT02621437|Other|phone questionnaires|"Six phone questionnaires (D9, D20, D26, D34, D40 and D48):
~pain questionnaire with digital scale,
~quality of life survey: SF-12
~HAD (Hospital and Anxiety Depression) questionnaire"
16036401|NCT02621424|Device|RTMS|stimulation of the brain with magnetic pulses
16036402|NCT02621424|Device|sham|sham noise to block the sound of stimulation
16036403|NCT02621411|Drug|Substance use|Patients are found use of substances by preoperative screen
16036404|NCT02621398|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo 3D-CRT or IMRT
16036405|NCT02621398|Drug|Carboplatin|Given IV
16036406|NCT02621398|Radiation|Intensity-Modulated Radiation Therapy|Undergo 3D-CRT or IMRT
16036407|NCT02621398|Other|Laboratory Biomarker Analysis|Correlative studies
16036408|NCT02621398|Drug|Paclitaxel|Given IV
16036409|NCT02621398|Biological|Pembrolizumab|Given IV
16036410|NCT02621385|Drug|tradipitant|test agent
16036411|NCT02621385|Drug|Midazolam|substrate for drug-drug interaction assessment
16036412|NCT02621372|Other|platelet count|Correlation of esophageal varices with platelet count
16036413|NCT02621359|Drug|Nitazoxanide|Nitazoxanide 500 mg twice daily
16036414|NCT02621359|Drug|Levofloxacin|Levofloxacin 500 mg once daily
16036415|NCT02621359|Drug|Doxycyclin|Doxycyclin 100 mg twice daily
16036416|NCT02621359|Drug|Omeprazole|Omeprazole 40 mg twice daily
16036417|NCT02621346|Behavioral|Imagery|Prior to exercising participants will be given an imagery script. Afterwards, participants will imagine completing the leg press.
16036418|NCT02621346|Behavioral|Muscle Maintenance|Participants complete the leg press exercises at an intensity that promotes muscle maintenance but not muscle growth
16036419|NCT02621346|Behavioral|Bicep Curls|Control group participants will complete a bicep exercise at a maintenance training intensity.
16036422|NCT02621320|Dietary Supplement|Vitamin D|Vitamin D3 (Vi-De 3®. WILD) 6000IU daily over a period of 12 weeks.
16036423|NCT02621320|Dietary Supplement|Placebo|alcohol-based solution 1.3ml daily over a period of 12 weeks.
16036427|NCT02621294|Other|Measuring protein requirement|a repeated measures design will be used on each athlete receiving eight graded intakes of protein on separate days in the form of AA in random order ranging from 0.2 to 3.5 g/(kg/d). Three baseline samples of breath and urine will be collected at 60, 45 and 30 min before the stable isotope is given orally. During a period of 150 to 270 min. after stable isotope ingestion, 5 breath and urine samples (every 30 min) will be collected to determine an isotopic plateau in breath and urine. The rate of release of 13CO2 from the oxidation of L-[1-13C] phenylalanine (F 13CO2) in breath will be measured and a breakpoint analysis will determine total protein requirement
16036428|NCT02621281|Device|Kidney Transporter machines|Kidney Transporter gently pumps the special cold solution through the kidney which outside the body.
16036429|NCT02621281|Device|cold storage|The kidneys procurement from the donor will be cold stored using some cold preservation solution.
16036430|NCT02621268|Drug|Indocyanine Green|Infusion of ICG 24 hours prior to surgery
16036431|NCT02621255|Drug|Sevoflurane|Anesthesia type of performed for patient which has femur fracture.
16036432|NCT02621255|Drug|Bupivacaine|Anesthesia type of performed for patient which has femur fracture.
16036433|NCT02621242|Procedure|Upper endoscopy|Upper endoscopy with biopsies
16036434|NCT02621242|Procedure|Anoscopy|Anoscopy with biopsies
16036435|NCT02621242|Drug|Truvada|Truvada (tenofovir/emtricitabine) daily as HIV pre-exposure prophylaxis. This medication will not be provided by the study.
16036436|NCT02621190|Drug|cabazitaxel|25mg/m2 q3w
16036437|NCT02621177|Biological|NBP607|For subjects 6 months to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 18 years of age, single intramuscular dose (0.25mL/0.5 mL)
16036438|NCT02621177|Biological|Agrippal S1|For subjects 6 months to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 18 years of age, single intramuscular dose (0.25mL/0.5 mL)
16036439|NCT02621164|Biological|NBP607-QIV|For subjects 6 months to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 18 years of age, single intramuscular dose (0.25mL/0.5 mL)
16036440|NCT02621164|Biological|Agrippal S1|For subjects 6 months to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 18 years of age, single intramuscular dose (0.25mL/0.5 mL)
16036441|NCT02621151|Biological|Pembrolizumab|
16036442|NCT02621151|Procedure|Transurethral Resection of Bladder Tumor|
16036443|NCT02621151|Drug|Gemcitabine|
16036444|NCT02621151|Radiation|External Beam Radiation Therapy|
16036445|NCT02621125|Dietary Supplement|Fertilix|daily supplementation
16036446|NCT02621125|Other|Placebo|Placebo
16036447|NCT02621112|Biological|Intradermal HBVv with imiquimod|Intradermal hepatitis B vaccine with imiquimod pretreatment
16036448|NCT02621112|Biological|Intradermal HBVv with aqueous cream|Intradermal hepatitis B vaccine with aqueous cream pretreatment
16036449|NCT02621112|Biological|Intramuscular HBVv with aqueous cream|Intramuscular hepatitis B vaccine with aqueous cream pretreatment
16036450|NCT02621099|Device|Hybrid optical-gamma imaging|Acquisition of images using the camera as additional steps to the standard SLNB procedures.
16036451|NCT02621086|Dietary Supplement|Cellodextrin|Gastrointestinal tolerability of single ascending doses of Cellodextrins
16036452|NCT02621073|Drug|VeraFlo with Prontosan|VeraFlo device with Prontosan instillation (n=10).
16036453|NCT02621073|Device|V.A.C Ulta System|V.A.C. Ulta Negative Pressure Wound Therapy System without instillation (n=10).
16036454|NCT02621060|Drug|Placebo|Placebo: 1200 mg per day for three months
16036455|NCT02621060|Drug|Chlorogenic acid|Chologenic acid: 1200 mg per day for three months
16036456|NCT02621047|Drug|Alectinib|Participants will receive alectinib as per the dosage schedule mentioned in arm description.
16036457|NCT02621034|Procedure|Control|K-file hand instrumentation
16036458|NCT02621034|Procedure|Reciproc|reciprocating rotary instrument
16036459|NCT02621034|Procedure|One shape|full rotation protocol
16036465|NCT02621008|Other|Stress Reduction& Healthy living|Utilizing a stress reduction app (Serenita) and lifestyle intervention App (NewMe) and obtaining the NewMe guideline for healthy living, plus obtaining periodic messages regarding healthy living.
16036466|NCT02620995|Drug|sildenafil citrate|the hypertensive patients with erectile dysfunction will be treated with sildenafil citrate (100 mg daily) or placebo (crossover design)
16036467|NCT02620995|Other|comparator group|Normotensive individuals age-matched to the hypertensive patients will receive only a single dose of sildenafil citrate (100 mg) - acute protocol. Penile and systemic microvascular function will be evaluated before and one hour after sildenafil administration.
16036468|NCT02620982|Device|ARIES (Extracorporal Shock Wave Application)|The treatment protocol includes 1 treatment per week for 6 weeks and an application of 5000 shockwaves per session in 5 treatment areas with 1000 SW each at energy level 4-5 (energy flux density (0.051-0.062 mJ/mm²), while moving the applicator along the penile shaft within the treatment areas. The maximum energy applied during this treatment would be 23.35J.
16036469|NCT02620969|Other|Blood and dialysate sampling|Blood and dialysate sampling
16036523|NCT02620631|Drug|Placebo|Subjects receive intrathecal, preservative-free normal saline pre-operatively in conjunction with post-operative PCA morphine
16038339|NCT02607644|Device|Laryngeal Tube (LT)|Laryngeal Tube (LT) for Intervention group
16036470|NCT02620956|Other|nebulizing with heliox and oxygen|Mesh Nebulizer with heliox and oxygen. In order to determine the sequence of the gas associated with the inhaled a randomization was performed, sequence 1- first oxygen and second heliox (80:20) or sequence 2- first heliox (80:20) and secondy oxygen.
16036471|NCT02620930|Device|All market approved CRT-D or ICD systems endowed with the APNEA Scan algorithm|
16036472|NCT02620904|Drug|Mifepristone|
16036473|NCT02620904|Drug|placebo|
16036474|NCT02620891|Device|helium oxygen mixture|
16036475|NCT02620878|Device|artificial pancreas|Patients will be randomly assigned to receive either 3 days of automated closed-loop insulin delivery (intervention) followed by 3 days of sensor -augmented pump therapy (control), or the inverted sequence.
16036476|NCT02620878|Other|sensor augmented pump|During this control period (comparator arm) the patients will use sensor augmented pump. This period will be compared to the same period of artificial pancreas
16036477|NCT02620865|Biological|Aldesleukin|Given SC
16036478|NCT02620865|Biological|Antibody Therapy|Given anti-CD3 x anti-EGFR-bispecific antibody armed activated T-cells IV
16036479|NCT02620865|Drug|Fluorouracil|Given IV
16036480|NCT02620865|Drug|Gemcitabine Hydrochloride|Given IV
16036481|NCT02620865|Drug|Irinotecan Hydrochloride|Given IV
16036482|NCT02620865|Other|Laboratory Biomarker Analysis|Correlative studies
16036483|NCT02620865|Drug|Leucovorin Calcium|Given IV
16036484|NCT02620865|Drug|Oxaliplatin|Given IV
16036485|NCT02620865|Drug|Paclitaxel Albumin-Stabilized Nanoparticle Formulation|Given IV
16036486|NCT02620865|Biological|Sargramostim|Given SC
16036487|NCT02620852|Other|Complete a health questionnaire|Complete a health history questionnaire.
16036488|NCT02620852|Device|Provide a saliva sample for genetic testing|Provide a saliva sample for testing of 9 genes and a panel of single nucleotide polymorphisms (SNPs) that influence breast cancer risk
16036489|NCT02620852|Other|Screening advice based on a comprehensive risk assessment|Receive a screening schedule recommendation
16036490|NCT02620852|Other|Screening advice based on a basic risk assessment|Receive a screening schedule recommendation
16036491|NCT02620839|Drug|Alpelisib|Given PO
16036492|NCT02620839|Drug|Cisplatin|Given IV
16036493|NCT02620826|Procedure|Indirect pulp therapy|Decayed dentin is lined with a resin-modified glass ionomer (Vitrebond Plus)
16036494|NCT02620826|Procedure|Pulpotomy|A cervical pulpotomy is done and the radicular pulp is lined with Mineral Trioxide Aggregate
16036495|NCT02620813|Drug|Tretinoin|Subjects will apply 0.5% tretinoin cream nightly to their face for a total of 12 weeks.
16036496|NCT02620813|Drug|Isotretinoin|Subjects will take isotretinoin as prescribed by their dermatologist.
16036497|NCT02620800|Drug|5FU|5 fluorouracil (5-FU) (180 mg/m^2/day for 14 days) by CIVI via ambulatory pump
16036498|NCT02620800|Drug|nab-paclitaxel|nab-paclitaxel (75 mg/m^2) as a 30-minute (min) IV infusion on Days 1, 8, and 15
16036499|NCT02620800|Drug|bevacizumab|bevacizumab (5 mg/kg) as an IV infusion on Days 1 and 15
16036500|NCT02620800|Drug|calcium leucovorin|calcium leucovorin (20 mg/m^2) IV bolus, on Days 1, 8, 15
16036501|NCT02620800|Drug|oxaliplatin|oxaliplatin (40 mg/m^2) as a 60-min IV infusion on Days 1, 8, and 15
16036502|NCT02620787|Drug|Tedizolid|
16036503|NCT02620787|Procedure|Microdialysis Catheter Insertion|A 20 kila-Dalton microdialysis probe (63 MD catheter; MDialysis Inc., N. Chelmsford, MA) will be inserted into the subcutaneous tissue at the margin of the wound (patient group) or in the thigh tissue (healthy volunteers). The probe will be left in place for the final dose and all tissue sampling procedures thereafter. This probe is perfused with a physiologic solution to collect interstitial fluid samples. The probe will then be removed after completion of sample collection.
16036504|NCT02620774|Drug|Ceftolozane/tazobactam|3 or more doses of ceftolozane/tazobactam intravenously administered over 60 minutes every 8 hours
16036505|NCT02620774|Procedure|Microdialysis Catheter Insertion|A 20 kila-Dalton microdialysis probe (63 MD catheter; MDialysis Inc., N. Chelmsford, MA) will be inserted into the subcutaneous tissue at the margin of the wound (patient group) or in the thigh tissue (healthy volunteers). The probe will be left in place for the final dose and all tissue sampling procedures thereafter. This probe is perfused with a physiologic solution to collect interstitial fluid samples. The probe will then be removed after completion of sample collection.
16036506|NCT02620761|Drug|Fenoldopam|Randomized to receive Fenoldopam or 0.9%NS
16036507|NCT02620761|Drug|0.9%NS|Randomized to receive Fenoldopam or 0.9%NS
16036508|NCT02620748|Drug|Tranexamic Acid|
16036509|NCT02620748|Other|Saline Solution|
16036510|NCT02620735|Device|Fit bit Device|Use of the fit bit flex for the duration of the study. Measures steps and sleep. Health Coaching
16036511|NCT02620735|Behavioral|Exercise Only|12 week exercise program
16036512|NCT02620735|Behavioral|Connected Wellness HealthCoach Software|Use of the app on Smart-phones and an online platform. Measures the following factors: Mood, Pain, energy,exercise not picked up by Fit bit.
16036513|NCT02620735|Behavioral|Health Coaching|10 over the phone health coaching sessions.
16036514|NCT02620722|Device|Personalized Tourniquet Instrument|Measure the limb occlusion pressure in each patient using the new technique with the personalized tourniquet instrument.
16036515|NCT02620722|Device|Handheld Doppler ultrasound|Measure the limb occlusion pressure in each patient using the gold-standard technique with the Doppler ultrasound.
16036516|NCT02620709|Behavioral|Hula intervention|Hula and heart health education
16036517|NCT02620696|Drug|netazepide|
16036518|NCT02620683|Drug|Lidocaine|See above
16036519|NCT02620670|Behavioral|Physical activity of moderate intensity for 3 days|The intervencion consist in a moderate-intensity physical activity exercise is a heart rate between 60 and 70% of maximum heart beats per minute for at least 30 minutes for three days
16036520|NCT02620657|Other|Non interventional study|Non interventional study
16036521|NCT02620644|Device|OCT Retinal GCC|measuring of the retinal ganglion cell complex (GCC) thickness and the central foveal thickness (CFT) using the RTVue® SD-OCT (Optovue, Inc.)
16036522|NCT02620631|Drug|Morphine|Subjects receive intrathecal morphine pre-operatively to determine its level of efficacy in acute pain control post-operatively when used in conjunction with post-operative PCA morphine
16039734|NCT02598089|Biological|Trivalent Seasonal Influenza Vaccine|
16036524|NCT02620618|Drug|Intravitreal Infliximab|ocular safety and efficacy in treating inflammation in uveitis patients with Behcets Disease
16036525|NCT02620605|Drug|Late Cabergoline 0.5mg|Cabergoline 0.5mg will be administrated once daily at day of HCG trigger and continued for 8days
16036526|NCT02620605|Drug|Early Cabergoline 0.5mg|Cabergoline 0.5mg will be administrated once daily when E2 is more than 4000pg/ml and /or more than 18 follicles of 11mm diameter or more are encountered at any day of the controlled ovarian hyper-stimulation and before HCG trigger to be continued for 8days after HCG trigger.
16036527|NCT02620592|Drug|ZYDPLA1 tablet|The oral dose of ZYDPLA1 tablet administered with 240 ± 10 mL of water at ambient temperature.
16036528|NCT02620592|Drug|Placebo tablet|The oral dose of placebo tablet administered with 240 ± 10 mL of water at ambient temperature.
16036529|NCT02620579|Drug|Propranolol LA (60 mg)|Long-acting propranolol (Propranolol LA) 60 mg to be administered orally daily for Days 1 (before exercise induced muscle injury) and Days 2-4 following exercise induced muscle injury.
16036530|NCT02620579|Drug|Placebo|Placebo capsules will be prepared by the University of Florida Investigational Drug Service to be visually indistinguishable from the active medication and delivered orally. Placebo administration will be done in the same fashion as propranolol - administered on Days 1 (before exercise induced muscle injury) and the Days 2-4 after the exercise induced muscle injury.
16036531|NCT02620579|Behavioral|Shoulder Anatomy Education|Shoulder anatomy education modules will be administered Days 2-4 (after exercised induced muscle injury) following exercise enhance injury with the goal of participant understanding shoulder anatomy and injury while reviewing: a) structure and arthrokinematics of the shoulder joint; b) muscle anatomy of the shoulder with emphasis on the rotator cuff; and c) potential shoulder pain generators from the exercise-induced injury. This education component will be devoid of information related to pain signaling and cognitive restructuring that characterizes Pain Processing Education modules. These education modules will be scripted and structured so they are provided in a standardized manner for all subjects.
16036532|NCT02620579|Behavioral|Pain Processing Education|Pain processing education modules will be administered Days 2-4 (after exercised induced muscle injury) following exercise enhance injury with the goal of better understanding of pain processing and psycho-education. This information will encourage shoulder activation by: a) reducing the threat of muscle injury; b) encouraging normal use of the shoulder and arm; and c) addressing specific concerns expressed by the subject (e.g. pain with shoulder motion is a sign of re-injury). This education component will be devoid of detailed information on shoulder anatomy, movement, and injury that characterizes the Shoulder Anatomy Education modules. These education modules will be scripted and structured so they are provided in a standardized manner for all subjects.
16036533|NCT02620566|Procedure|Bupivacain- Caudal|Bupivacain for caudal blocks, Group C received 1 ml kg of 0.25% (maximum volume 20 ml).
16036534|NCT02620566|Procedure|Bupivacaine- Local|Bupivacain for Local Wound Infiltration Group L received 0,2 ml kg 0,25% (maximum volume 4 ml).
16036535|NCT02620553|Drug|Human Insulin|There is a study drug dose increase once during the study. The dose increase will occur 6 months after entering into the study. A total of 6 children will be included at each dose (3 children will not have received insulin prior to entering the study and 3 children will have received a lower dose of insulin for 6 months). Further dose increases or more frequent dose increases in individual children will not be performed during Pre-POINT. Escalation will occur in both treatment and placebo group so that participants and study investigators will remain blinded to treatment throughout the study. First dose (2.5 mg oral insulin/day) Second dose (7.5 mg oral insulin/day) Third dose (22.5 mg oral insulin/day) Fourth dose (67.5 mg oral insulin/day)
16036536|NCT02620553|Other|Oral Placebo|Oral Placebo is given orally daily
16036537|NCT02620540|Device|Accuracy of an algorithm and the Broselow Tape|Computer based comparison of the two devices based on collected patient data
16036538|NCT02620514|Behavioral|Education and Reminders|Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will be provided education materials, and will receive scheduled educational reminder phone calls and text messages at 2,6,12, and 24 weeks from the baseline assessment.
16036539|NCT02620514|Behavioral|Educational Visit|Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence.Participants will undergo one scheduled visit with a nurse practitioner or physician for education about inflammatory bowel disease (IBD) after the baseline assessment.
16036540|NCT02620514|Behavioral|Medication Educational Visit|Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will undergo one scheduled visit with a nurse practitioner or physician to discuss medication side effects and medication inadequacy after the baseline assessment.
16036541|NCT02620514|Behavioral|Financial Support|Participants with inflammatory bowel disease (IBD) will complete health-literacy surveys to assess medication adherence. Participants will receive information about patient assistance programs, copay cards, and a scheduled meeting with a social worker or financial advisor.
16036542|NCT02620501|Drug|Lidocaine|topical lidocaine
16036543|NCT02620501|Drug|Placebo|0.45% Normal Saline
16036544|NCT02620488|Behavioral|Guided Imagery|Brief guided imagery session with a trained clinician focused on relaxation and pleasant imagery.
16036545|NCT02620475|Device|SutureSafe|SutureSafe dressing are designed to apply a constant gentle inward pressure on the incision to reduce separating tension on newly formed incisions, stabilizing the healing environment.
16036546|NCT02620462|Device|Wearable sensor-based exercise training|The device provides real-time visual feedback of joint movement during balance exercise
16036547|NCT02620449|Other|Diet|Participants will be fed a low-additive diet as the primary intervention
16036548|NCT02620436|Other|Core Mother Shelter Model|"Infrastructure, Supplies, Equipment: All MHs will have: latrines, lockable cupboards, doors, windows, lighting, mattresses, mosquito nets, cooking space and utensils, and a bathing site.
~Policies, Management, Finances:. The policies, management, and financial structures will follow the same general principles, but will be site-specific to account for cultural variation.
~Linkages with Health Facilities: Each MH will be operationally linked to the health facility and 1) ensure daily check-ins by a health facility staff; 2) ensure every pregnant woman has someone able to contact a staff if she is incapacitated; and 3) will orient women to procedures upon arrival. Clinical services will be conducted at the health facility."
16039735|NCT02598089|Other|Placebo|0.5 mL of phosphate buffered saline
16036549|NCT02620423|Biological|REOLYSIN®|4.5x10E10 TCID50 1 hour intravenous infusion, administered on Day 1 and 2 of a 21-day cycle
16036550|NCT02620423|Drug|Chemotherapy|Patients may be treated with one of three chemotherapy backbone regimens. The decision on the chemotherapy backbone is based on physician preference.This includes either: a) Gemcitabine or b) Irinotecan or c)Leucovorin followed by 5-fluorouracil
16036551|NCT02620423|Drug|Gemcitabine|1000 mg/m2 intravenous infusion over 30 minutes on Day 1 of a 21-day cycle or
16036552|NCT02620423|Drug|Irinotecan|125 mg/m2 intravenous infusion over 90 minutes on Day 1 of a 21-day cyle or
16036553|NCT02620423|Drug|Leucovorin|Leucovorin (LV) followed by 5-fluorouracil (5FU). LV 200 mg/m2 intravenous infusion over 2 hours on Day 1, 5FU 200 mg/m2 intravenous infusion bolus over 5-10 minutes on Day 1, followed by 5FU 1200 mg/m2 continuous intravenous infusion over 22 hours on Day 1 of a 21-day cycle
16036554|NCT02620423|Drug|5-fluorouracil|Leucovorin (LV) followed by 5-fluorouracil (5FU). LV 200 mg/m2 intravenous infusion over 2 hours on Day 1, 5FU 200 mg/m2 intravenous infusion bolus over 5-10 minutes on Day 1, followed by 5FU 1200 mg/m2 continuous intravenous infusion over 22 hours on Day 1 of a 21-day cycle
16036555|NCT02620423|Drug|Pembrolizumab|Pembrolizumab, 2 mg/kg intravenous infusion 30 minutes on Day 8 of a 21-day cycle
16036556|NCT02620410|Device|Axonics Sacral Neuromodulation (SNM) System|The implantable components of the Axonics Sacral Neuromodulation (SNM) System consist of an IPG and tined lead. Additional components include a clinician programmer, surgical tool kit, recharging kit, and patient remote control.
16036557|NCT02620384|Drug|Experimental: Placebo|All patients will receive standard heart failure therapy, including but not restricted to diuretics, digoxin, angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, aldosterone antagonists, hydralazine, and/or nitrates, at the discretion of the treating physician. After informed consent is obtained, patients will be randomized 1:1 to the treatment arm or placebo arm. The first placebo dose is given within six hours of admininstration of first dose of intravenous diuretic. The second placebo dose is given at 24-hours after the first dose.
16036558|NCT02620384|Drug|Experimental: Metolazone|All patients will receive standard heart failure therapy, including but not restricted to diuretics, digoxin, angiotensin converting enzyme inhibitors or angiotensin II receptor blockers, beta blockers, aldosterone antagonists, hydralazine, and/or nitrates, at the discretion of the treating physician. After informed consent is obtained, patients will be randomized 1:1 to the treatment arm or placebo arm. The first dose of metolazone is given within six hours of admininstration of first dose of intravenous diuretic The second dose of metolazone is given 24-hours after the first dose.
16036559|NCT02620371|Procedure|modified pectoral block|"Modified Pecs block was performed under general anesthesia, and 15 min. before skin incision. We performed the modified Pecs block or the  Pecs II block by using a two needle approach instead of one. The first puncture is a Pecs I block with 10 ml of local anesthetic injected between the two pectoralis muscles, and the second puncture injects 20 ml of local anesthetic between the Pectoralis minor muscle and the serratus muscle. This breaks through the 'axillary door' and will reach the long thoracic nerve and reliably at least two intercostal nerves.
~We used A high frequency linear US probe is used for this block. a broadband linear array probe, with an imaging depth of 3-4cm. starting from the lateral third of the clavicle and moving distally and laterally to the mid axillary line."
16036560|NCT02620358|Other|T Tube for 120 minuts|Spontaneous Breathing Trial using T Tube for 120 minutes.
16036561|NCT02620358|Other|Pressure Support Ventilation of 8 cmH2O for 30 minutes|Spontaneous Breathing Trial using Pressure Support Ventilation of 8 cmH2O for 30 minutes
16036562|NCT02620345|Drug|Dydrogesterone M ( case 1 )|"Dydrogesterone Multivitamin nature
~Fibroids / Women Pregnancy ( discovered fibroids during pregnancy ) Dydrogesterone Multivitamin nature.
~1tablet/24 hours/day (to 4 weeks after postpartum)"
16036563|NCT02620345|Drug|Dydrogesterone M ( case 2 )|"Dydrogesterone Multivitamin nature
~Fibroids/ Women of Reproductive age ( discovered fibroids )
~1tablet/24 hours/day ( from discovered fibroids through 6 months)"
16036564|NCT02620332|Drug|MultiPepT1De injection|A mix of peptides
16036565|NCT02620332|Other|Placebo|Water for injection
16036566|NCT02620319|Device|SX-ELLA Stent DV Tracheal (DV Stent)|The trachea is intubated with a rigid bronchoscope while participants are placed under total intravenous anesthesia and jet ventilation. The delivery apparatus containing the stent is introduced through a rigid tube to the desired depth under visual control. Then the stent is deployed and its position is determined and, if necessary, stent is repositioned using rigid forceps. In-stent balloon dilation is carried out. If needed, thoracic surgeon can secure the stent in place via external (percutaneous) fixation: one suture is passed through the stent, the tracheal wall, soft tissues, and skin; the suture is then knotted on the skin of the neck. The suture is removed two to three weeks after implantation.
16036567|NCT02620306|Drug|Fimsartan 60mg~120mg|Standard BP control group (SBP < 140 mmHg). In case of patients with blood pressure that cannot be controlled to the targeted level during the entire clinical study period, the dose of study drug is increased or other antihypertensive drugs are administered concomitantly.
16036568|NCT02620306|Drug|Fimsartan 60mg~120mg|Strict BP control group (SBP < 130 mmHg). In case of patients with blood pressure that cannot be controlled to the targeted level at each visit during the entire clinical study period, the dose of study drug is increased or other antihypertensive drugs are administered concomitantly.
16036569|NCT02620306|Drug|Losartan 50mg~100mg|Standard BP control group (SBP < 140 mmHg). In case of patients with blood pressure that cannot be controlled to the targeted level during the entire clinical study period, the dose of study drug is increased or other antihypertensive drugs are administered concomitantly.
16036570|NCT02620306|Drug|Losartan 50mg~100mg|Strict BP control group (SBP < 130 mmHg). In case of patients with blood pressure that cannot be controlled to the targeted level at each visit during the entire clinical study period, the dose of study drug is increased or other antihypertensive drugs are administered concomitantly.
16036571|NCT02620293|Device|Eczema Repair Emollient|An Emollient
16036572|NCT02620280|Drug|Carboplatin|Carboplatin AUC 2 will be given i.v. on day 1 and day 8 q 3 weeks for a total of 8 cycles
16036573|NCT02620280|Drug|Abraxane|Abraxane, 125 mg/m2 will be given i.v. on day 1 and day 8 q 3 weeks for a total of 8 cycles
16036574|NCT02620280|Drug|MPDL3280A|MPDL3280A, 1200 mg. will be given i.v. infusion on day 1 q 3 weeks for a total of 8 cycles
16036575|NCT02620280|Procedure|Surgery|Breast cancer surgery (breast and axilla) either conservative or radical not later than 6 weeks
16036576|NCT02620280|Drug|Anthra|AC or EC (adriamycin or epirubicin and cyclophosphamide) or FEC (fluorouracil, epirubicin, and cyclophosphamide) on day 1 every three weeks for 4 cycles to be delivered after surgery
16036577|NCT02620267|Device|tDCS Stimulation|Subjects will receive tDCS stimulation over the auditory cortex for 20 min. For anodal stimulation the anode electrodes will be placed over the auditory cortex. For cathodal stimulation, the cathode electrodes will be placed over the auditory cortex. For sham stimulation, the anode electrodes will be placed over the auditory cortex and current turned on for 30 sec before being turned off to simulate the sensation of active stimulation.
16036578|NCT02620241|Other|sitting position|
16036579|NCT02620228|Device|BIP Biopsy System|BIP Biopsy system is essentially similar as traditional biopsy systems but it enables real-time bioimpedance measurement from the tip of the biopsy needle.
16036580|NCT02620215|Device|Cervical Ripening Balloon|Cook® Cervical Ripening Balloon with Stylet Order number G19891 Reference Part Number J-CRBS-184000 Catheter (Fr) 18.0 Length (cm) 40 Balloon Volume (mL) 80
16036581|NCT02620215|Drug|Prostin|Prostin E2 vaginal tablets contain the active ingredient dinoprostone, which is a naturally occuring female hormone also known as prostaglandin E2. Prostaglandins are involved in naturally starting labour. Dose of Prostin is 3 mg vaginally.
16036582|NCT02620189|Drug|Anti-TNF Biologics Therapy|
16036583|NCT02620176|Device|Transcutaneous vagal nerve stimulation|Trans-auricular vagal nerve stimulation
16036584|NCT02620163|Drug|telmisartan/amlodipine 40/5mg|
16036585|NCT02620163|Drug|YH22162 40/5/12.5 mg|
16036586|NCT02620163|Drug|telmisartan/amlodipine 80/5mg|
16036587|NCT02620163|Drug|YH22162 80/5/25 mg|
16036588|NCT02620163|Drug|telmisartan/amlodipine 40/5mg placebo|
16036589|NCT02620163|Drug|YH22162 40/5/12.5 mg placebo|
16036590|NCT02620163|Drug|telmisartan/amlodipine 80/5mg placebo|
16036591|NCT02620163|Drug|YH22162 80/5/25 mg placebo|
16036592|NCT02620150|Drug|Escitalopram|10 week trial
16036593|NCT02620150|Other|Placebo|10 week trial
16036594|NCT02620137|Drug|Multicentrum® (Pfizer, Spain) 3 months|The multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) will be maintained during 3 months
16036595|NCT02620137|Drug|Multicentrum® (Pfizer, Spain) 12 months|The multivitamin supplement (Multicentrum® (Pfizer, Spain) 1 tablet/day) will be maintained during 12 months
16036596|NCT02620124|Drug|Natural cycle: Triptorelin acetate 0.1 mg|A single dose of triptorelin acetate 0.1 s.c. was giwen when the age of the transferred embryo was six days in additon to standard micronized progesterone 400 mg vaginally
16036597|NCT02620124|Drug|Hormone replacement cycle and triptorelin acetate 0.1 mg|A single dose of triptorelin acetate 0.1 s.c. was giwen when the age of the transferred embryo was six days in addition to standard Estradiol and progesterone support
16036598|NCT02620111|Dietary Supplement|Whey protein high in leucin|This Group is analysed for muscle protein synthesis and breakdown, mTor pathway signaling and Amino acid metabolism while supplemented first water then whey protein high in leucin
16036599|NCT02620111|Dietary Supplement|Whey protein normal in leucin|This Group is analysed for muscle protein synthesis and breakdown, mTor pathway signaling and Amino acid metabolism while supplemented first water then whey protein normal in leucin.
16036600|NCT02620098|Other|Size Matters Handwriting Program|The Size Matters Handwriting Program (Moskowitz, 2009) (SMHP) program incorporates principles grounded in motor learning theory, cognitive theory, and motivation theory. Children learn the importance of letter size by learning size 1 (capital and tall letters), size 2 (small letters) and size 3 letters (those that dive below the baseline) at different stages (Moskowitz, 2009). The intervention group received a total of 30 sessions of the SMHP, completed twice weekly over a 16 week period. Sessions lasted 30 minutes, and were led by an occupational therapist with training in the Size Matters Handwriting Program. All interventions were provided within the existing support classrooms. Each child had their own SMHP workbook.
16036601|NCT02620085|Procedure|blood sampling|blood sampling
16036602|NCT02620072|Drug|Oral Insulin|Total of 12 months treatment; dose escalation scheme: daily treatment with 7.5 mg or placebo for 3 months; increasing to daily treatment with 67.5 mg or placebo for the following 9 months of the treatment period. Follow-up will continue for 24 months after the last administration of treatment.
16036603|NCT02620072|Other|Placebo|Total of 12 months intervention period; daily administration of insulin or placebo capsules containing filling substance (microcrystalline cellulose). Follow-up will continue for 24 months after the last administration of treatment.
16036604|NCT02620059|Behavioral|Lifestyle Intervention|The investigators will provide information on healthy eating and physical activity. They will give pedometers to the participants to monitor their daily steps in order to increase it till 10000 steps/day.
16036605|NCT02620046|Drug|Vedolizumab SC|Vedolizumab SC 108 mg injection
16036606|NCT02620033|Behavioral|Yoga therapy|
16036607|NCT02620020|Drug|Fasinumab|Participants received fasinumab SC or IV, Q4W or Q8W.
16036608|NCT02620020|Drug|placebo|Participants received placebo matching to fasinumab SC or IV, Q4W or Q8W.
16036609|NCT02620007|Drug|Ciprofloxacin|oral Ciprofloxacin 500 mg bis in die (bid) for 12 weeks
16036610|NCT02620007|Drug|Rifaximin|oral Rifaximin 800 mg bid for 12 weeks
16036611|NCT02620007|Drug|Ciprofloxacin Placebo|a placebo of Ciprofloxacin bid for 12 weeks
16036612|NCT02620007|Drug|Rifaximin Placebo|a placebo of Rifaximin bid for 12 weeks
16036613|NCT02619994|Drug|Linezolid|
16036614|NCT02619994|Drug|Delamanid|
16036615|NCT02619994|Drug|Levofloxacin|
16036616|NCT02619994|Drug|Pyrazinamide|
16036617|NCT02619994|Drug|Locally-used WHO-approved MDR-TB regimen in Korea|
16036618|NCT02619981|Procedure|Restorative procedure|A restorative dental procedure requiring maxillary buccal infiltration anesthesia, and not exceeding 30 minutes of working time
16036619|NCT02619981|Drug|Maxillary infiltration anesthesia with 2%Lidocaine|1.8ml of 2% Lidocaine with adrenaline administered using a 27 gauge 21mm needle
16036620|NCT02619968|Other|experimental group|Will be held isometric and isotonic concentric to the flexor muscles of the elbow and wrist using tennis ball, halter and handgrip added to partial occlusion of blood flow to tourniquet application. The Application of the tourniquet will be held in conjunction with exercises for the experimental group.
16036621|NCT02619955|Other|samples with DNA|
16036622|NCT02619942|Procedure|D2 radical operation|In D2 radical operation group(D2), the lymph node dissection is based on ligating the supplying vessels close to the right-side of superior mesenteric vein and clean up the surrounding lymph node and adipose tissue.
16036623|NCT02619942|Procedure|Complete mesocolic excision (CME)|In complete mesocolic excision group (CME), the dissecting extent includes the lymphatic and fat tissues surrounding the root of ascending mesocolon, which situated on the surface of superior mesenteric vein, and the root of right half of transverse mesocolon, which situated on the surface of pancreas neck.
16036624|NCT02619929|Drug|Vinorelbine oral|
16036625|NCT02619916|Behavioral|Mindfulness-Based Cognitive Therapy (MBCT)|The intervention consists of 8 weekly individual sessions of MBCT. Each session will be administered individually and will last 60 minutes
16036626|NCT02619916|Behavioral|Cognitive Behavioral Therapy (CBT)|The intervention consists of 8 weekly individual sessions of CBT. Each session will be administered individually and will last 60 minutes.
16036627|NCT02619903|Procedure|Dental cleaning|Dental scaling and cleaning to remove dental plaque as well as removing the tongue biofilm.
16036628|NCT02619890|Other|Brain Glioma Registry|
16036629|NCT02619877|Biological|ALLO-ASC-DFU|Application of ALLO-ASC-DFU sheet to diabetic foot ulcer
16036630|NCT02619877|Other|Standard therapy|Standard therapy conducted for patients with diabetic foot ulcer
16036631|NCT02619864|Drug|AZD2014|
16036632|NCT02619851|Biological|ALLO-ASC-DFU|Dressing for Second Deep degree Burn injury
16036633|NCT02619851|Device|Conventional Therapy|Typical therapy conducted for burn injury patients
16036634|NCT02619838|Device|Aptus CCS 5.0 or/and 7.0 screws|Fusion of the talonavicular joint, the subtalar joint, and the calcaneal-cuboid joint with a Aptus CCS screws. The assignment of the device is at the discretion of the standard of care provider, not the study investigator.
16036635|NCT02619825|Device|Echography|cardiac ultrasound, in two stages, with an estimate of the stiffness of the myocardium ShearWave Elastography (Aixplorer®) and measurement of all echocardiographic parameters estimated in children with a clinical ultrasound Machine
16036636|NCT02619825|Device|Elastography|cardiac ultrasound, in two stages, with an estimate of the stiffness of the myocardium ShearWave Elastography (Aixplorer®) and
16036637|NCT02619812|Other|Serum-derived bovine immunoglobulin/protein isolate (SBI)|SBI 10 grams (The subject will take a total of 4 packets of SBI; taken as two packets of SBI twice a day mixed with water or blended with certain foods)
16036638|NCT02619812|Drug|Colesevelam|Colesevelam 1.875 g (The subject will take a total of 12 capsules of Welchol 1.875g per day; taken as 6 capsules twice a day by mouth).
16036639|NCT02619812|Other|Double Placebo|Double placebo twice per day (The subject will take a total of 4 packets of placebo and 12 capsules daily taken as 6 capsules twice a day by mouth and two packets of placebo twice a day mixed with water or blended with certain foods).
16036640|NCT02619799|Drug|intrathecal magnesium sulphate,|comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine
16036641|NCT02619799|Drug|Intrathecal midazolam|comparision of effects of intrathecal magnesium sulphate with intrathecal midazolam when administered along with epidural 0.75% Ropivacaine
16036642|NCT02619786|Drug|Inhaled colistin|75 mg of colistin activity, inhaled per dose, every 12 hours
16036643|NCT02619773|Procedure|mupirocin ointment|Mupirocin ointment will be applied after skin closure. A standard island dressing will be placed over the incision.
16036644|NCT02619760|Drug|1-month DAPT|1-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists
16036645|NCT02619760|Drug|12-month DAPT|12-month dual antiplatelet therapy (DAPT) composed of aspirin and P2Y12 receptor antagonists
16036646|NCT02619747|Drug|Compound Sodium Alginate Oral Suspension sachet|
16036647|NCT02619747|Drug|Matched placebo|
16036648|NCT02619734|Biological|Infusion of Autologous Bone Marrow Mononuclear Cells|Autologous bone marrow-derived mononuclear cells will be administered by intramuscular injection into and around the leg ulcer. The number of injected cells will be from 5x108 to 1x109 total number of cells on Study Day 1.
16036649|NCT02619721|Device|PINS SNS|
16036650|NCT02619708|Behavioral|Immersive Preoperative Experience|The video will include a simulated patient encounter (with actors not real patients) showcasing the preoperative experience of the patient, including getting checked in, meeting the nurses, surgeons, and the anesthesiologists. The technology used will allow the immersion of the patient in the preoperative environment. Patients will be able to look around and explore the spaces they will visit on the day of their operation.
16036651|NCT02619695|Drug|Fastjel|2.5% ketoprofen gel (Fastjel) has been administer as 2 gr in 5 cm area.
16036652|NCT02619682|Drug|Ixazomib Citrate|Given PO
16036653|NCT02619682|Other|Laboratory Biomarker Analysis|Correlative studies
16036654|NCT02619682|Drug|Lenalidomide|Given PO
16036655|NCT02619669|Drug|TAK-228|Millennium has developed TAK-228, which is a novel, highly selective, orally bioavailable adenosine 5' triphosphate (ATP)-competitive inhibitor of the serine/threonine kinase referred to as the mechanistic target of rapamycin (mTOR). TAK-228 (formerly INK128 or MLN0128) targets 2 distinct multiprotein complexes, mTORC1 and mTORC2. TAK-228 selectively and potently inhibits mTOR kinase (IC50 = 1.1 nM), inhibits mTORC1/2 signaling, and prevents cellular proliferation.
16036656|NCT02619669|Drug|Letrozole|An aromatase inhibitor that has a greater inhibitory effect on Ki67 (marker of cell proliferation).
16036657|NCT02619656|Procedure|CO2 insufflation|Patients were randomized to insufflation with CO2.
16036658|NCT02619656|Procedure|Ambient air insufflation|Patients were randomized to insufflation with ambient air.
16036659|NCT02619643|Device|Transcranial Magnetic Stimulation (Magstim)|
16036660|NCT02619630|Drug|nelarabine|"Nelarabine 1500 mg/m2/d (IV 2h) : D1, D3, D5 Cyclophosphamide 150 mg/m2/d (IV 3h) : D1, D3 etoposide (VP-16) 75 mg/m2/d (IV 1h) : D1, D3 granulocyte-colony stimulating factor 5 µg/kg/d (SC) : D7 until neutrophil >1 Giga/Liter
~for a maximum of 5 blocks"
16036661|NCT02619617|Drug|SOM230|The study evaluated SOM230 vs Placebo
16036662|NCT02619617|Drug|Placebo|The study evaluated SOM230 vs Placebo
16036695|NCT02619409|Drug|EPI75 group|The EPI75 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.075cc, and sterile saline 0.025%.
16036696|NCT02619409|Drug|EPI100 group|The EPI100 group will receive bupivacaine 0.5% 3cc, and epinephrine 1:1000 0.1cc.
16036663|NCT02619604|Other|Education Intervention|Education interventions will be delivered sporadically within the 6-month window between the time the clinician completes the pre-survey and when he/she completes the post-survey. Interventions consist of e-brief publications, teleconferences with project faculty, and evidence based resources.
16036664|NCT02619591|Other|Ultrasound Imaging|views of a hemithorax was obtained using the Zonare Ultrasound machine.
16036665|NCT02619578|Other|TEAS|According to the theory of traditional Chinese medicine, bilateral Baihui (GV20), Yingtang (EX-HN3), Zusanli (ST36) and Neiguan (PC6) were chosen as the acupuncture points. These acupoints were identified according to the traditional anatomic localization . Gel electrodes were applied to the skin after it had been cleaned with ethyl alcohol. The acupoints were then stimulated electrically with an intensity of 12-15 mA and dense-disperse frequency of 2/100 Hz for 30 min, using the Hwato electronic acupuncture treatment instrument (model No. SDZ-V, Suzhou Medical Appliances Co., Ltd, Suzhou, China). The intensity was adjusted to maintain a slight twitching of local muscles according to individual maximum tolerance, indicating a satisfactory of De-Qi phenomenon and thus adequate stimulation.
16036666|NCT02619578|Other|Con|The patients in the Con group had the electrodes applied at the same acupoints, but received no stimulation.
16036667|NCT02619578|Drug|propofol, remifentanil, vecuronium|Anesthesia was induced i.v. with propofol (2 mg kg-1) and remifentanil (1 μg kg-1) using a target-controlled infusion (TCI) system. After loss of consciousness, vecuronium (0.1 mg kg-1) was administered i.v.
16036668|NCT02619578|Other|mechanical ventilation|Patients' lungs were mechanically ventilated in a volume-controlled mode with a tidal volume of 8ml kg-1 body weight during the operation.
16036669|NCT02619565|Other|blood samples|blood samples at Day 0 and also if there is an evolution of the disease
16036670|NCT02619552|Drug|Anti-TNF|All participants in this arm receive an anti-TNF for the treatment of luminal CD. They are required to undergo study visits at baseline, 2 months, and 6 months in addition to any other routine visits. Sexual function, body image, disease activity, quality of life, and depression scores will be measured at baseline and at each study visit during the 6-month study.
16036671|NCT02619552|Drug|Anti-TNF|All participants in this arm receive an anti-TNF for the treatment of perianal CD. They are required to undergo study visits at baseline, 2 months, and 6 months in addition to any other routine visits. Sexual function, body image, disease activity, quality of life, and depression scores will be measured at baseline and at each study visit during the 6-month study.
16036672|NCT02619552|Drug|Steroids|All participants in this arm receive steroids for the treatment of luminal CD. They are required to undergo study visits at baseline, 2 months, and 6 months in addition to any other routine visits. Sexual function, body image, disease activity, quality of life, and depression scores will be measured at baseline and at each study visit during the 6-month study.
16036673|NCT02619539|Procedure|plasma fibrinogen measurement|plasma fibrinogen measurement
16036674|NCT02619526|Drug|Nebivolol|Nebivolol 10mg, once a day
16036675|NCT02619526|Drug|Carvedilol|Carvedilol 25mg, twice a day
16036676|NCT02619513|Drug|Dexmedetomidine|Group GTD received thoracic continuous paravertebral nerve block with dexmedetomidine (0.5μg/kg) added to ropivacaine before anesthesia induction, and used continuous thoracic paravertebral nerve block patient-controlled analgesia(with dexmedetomidine 100μg）.
16036677|NCT02619513|Drug|Ropivacaine|Group GE\GT\GTD respectively received continuous nerve blocks and postoperative analgesia combined with ropivacaine.
16036678|NCT02619513|Device|Mindray M7 series|Ultrasound real-time guidance have been used in continuous thoracic paravertebral blocks in group GT and group GTD.
16036679|NCT02619500|Other|Home Exercise Program|A standardized home exercise program will be given to subjects that will include active range of motion of the cervical and thoracic spine and deep cervical flexion endurance exercises.
16036680|NCT02619500|Other|Patient advice, encouragement, and education|Therapists will provide each subject with advice and education pertaining to their condition as well as encouragement towards reducing pain and disability.
16036681|NCT02619500|Other|Thrust Manipulation|High velocity low amplitude (HVLA) thrust performed at or near the end range of a targeted segment in both the cervical and thoracic spine
16036682|NCT02619500|Other|Non-thrust Mobilizations|Repetitive and rhythmic accessory passive movements applied with either small or large amplitude at a targeted segment to both the cervical and thoracic spine
16036683|NCT02619487|Other|text message to parent only|A weekly text message of an educational or motivational nature and related to Type 1 Diabetes will be sent for a duration of one year
16036684|NCT02619487|Other|text message to parent and adolescent|A weekly text message of an educational or motivational nature and related to Type 1 Diabetes will be sent for a duration of one year
16036685|NCT02619474|Other|Whiteboard|"On morning rounds, the child's management will be discussed with the family and the day's plan for treatment and investigations will be written on the whiteboard.
~The second step will be to review and update the whiteboard at the end of the day. Anything that has been left out or uncompleted will be highlighted and brought up on the following morning's rounds. Next, the nurse will ask the family to write down any questions.
~Lastly, on the afternoon before a child's discharge, the nurse will take particular care to make sure the parents write down all of their concerns prior to going home. These specific questions concerning discharge planning will be addressed in detail at rounds the following morning."
16036686|NCT02619461|Other|Exercise|Exercise at 70%VO2max on a recumbent bicycle for 30 minutes to investigate the effects of exercise at high intensities on appetite and biomarkers of appetite and inflammation.
16036687|NCT02619448|Drug|Carboplatin|chemotherapy
16036688|NCT02619448|Drug|Paclitaxel|chemotherapy
16036689|NCT02619448|Radiation|70 Gy in 20 fractions over 4 weeks|accelerated hypofractionated RT
16036690|NCT02619435|Drug|regorafenib|Patients will receive regorafenib orally 160 mg once daily for the first 3 weeks of each 4-week cycle.
16036691|NCT02619422|Other|Intensive cardiac rehabilitation program in less time|2 weeks, 5 days a week, and reinforcement sessions at 3, 6 and 9 months
16036692|NCT02619409|Drug|Bupivacaine Only|The bupivacaine only group will receive bupivacaine 0.5% 3cc plus sterile saline 0.1cc.
16036693|NCT02619409|Drug|EPI25|The EPI25 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.025cc, and sterile saline 0.075cc.
16036694|NCT02619409|Drug|EPI50 group|The EPI50 group will receive bupivacaine 0.5% 3cc, epinephrine 1:1000 0.05cc, and sterile saline 0.05cc
16036697|NCT02619396|Procedure|Combination 1 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall|20 W RF power and target LSI = 4 on LA posterior wall
16036698|NCT02619396|Procedure|Combination 2 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall|40 W RF power and target LSI = 4 on LA posterior wall
16036699|NCT02619396|Procedure|Combination 3 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall|20 W RF power and target LSI = 5 on LA posterior wall
16036700|NCT02619396|Procedure|Combination 4 of radiofrequency (RF) power and Lesion Size Index (LSI) on left atrial (LA) posterior wall|40 W RF power and target LSI = 5 on LA posterior wall
16036701|NCT02619383|Device|Hyperbaric oxygen therapy|The treatment comprised 40 daily hyperbaric sessions, 5 days a week, in a multiplace hyperbaric chamber (HAUX-Life-Support GmbH). Each session consisted of 90 minutes of exposure to 100% oxygen at 2 ATA with 5 minutes air breaks every 30 minutes and 1 meter per minute compression and decompression.
16036702|NCT02619370|Behavioral|Conversation card game|
16036703|NCT02619370|Behavioral|Active Control|
16036704|NCT02619357|Device|SenseWear Armband Gecko|Subjects will wear SenseWear Armband Gecko up to 24 hours per day for 2 days while performing usual activities of daily living, strength exercises, laboratory-based, and field-based exercise tests
16036705|NCT02619357|Device|SenseWear Armband MF|Subjects will wear SenseWear Armband MF up to 24 hours per day for 2 days while performing usual activities of daily living, strength exercises, laboratory-based, and field-based exercise tests
16036706|NCT02619357|Device|Actigraph GT9x wristband and waistband|Subjects will wear Actigraph GT9x wristband and waistband up to 24 hours per day for 2 days while performing usual activities of daily living, strength exercises, laboratory-based, and field-based exercise tests
16036707|NCT02619357|Device|Garmin Vivofit 2 wristband|Subjects will wear Garmin Vivofit 2 wristband up to 24 hours per day for 2 days while performing usual activities of daily living, strength exercises, laboratory-based, and field-based exercise tests
16036708|NCT02619357|Device|SOMNOwatch plus EEG 6 sleep monitor|In a subset of subjects, this device will be worn as a comparator for monitoring sleep quality and duration.
16036709|NCT02619357|Other|Strength exercises|Subjects will perform strength exercises using elastic bands of varying resistance
16036710|NCT02619357|Other|Field-based exercise tests|Subjects will perform an Incremental Shuttle Walk Test (ISWT) and each individual component of a Short Physical Performance Battery (SPPB).
16036711|NCT02619357|Other|Laboratory-based exercise tests|Subjects will perform an incremental, symptom-limited cardiopulmonary exercise test on a cycle ergometer and will walk at various speeds on a treadmill
16036712|NCT02619331|Procedure|Allergy test reading|Reading of allergy skin tests (in response to allergen extracts or histamine or negative control) by HSL-DI versus direct observer evaluation (CWFM)
16036713|NCT02619318|Behavioral|Balancing Everyday Life (BEL)|
16036714|NCT02619318|Behavioral|Care as usual (generally standard occupational therapy)|
16036715|NCT02619305|Other|Social network tie|Participants will be social network ties of women receiving a livelihood intervention package consisting of a orientation and training and a loan package of chickens and associated implements to create poultry microenterprises.
16036716|NCT02619292|Behavioral|Mindful Movement Program|Mindfulness is turning one's awareness to the present moment. Movement-dance therapy is the expression of thoughts or feelings through body movement, under the supervision of a licensed professional.
16036717|NCT02619279|Other|Livelihood intervention|Participants' mothers will receive a livelihood intervention package consisting of a orientation and training and a loan package of chickens and associated implements to create poultry microenterprises.
16036718|NCT02619266|Other|Acupuncture|Acupuncture is the practice of inserting thin needles into specific points to improve health and well-being.
16036719|NCT02619266|Other|Sham Acupuncture|Sham acupuncture is used as a control in scientific studies that test the efficacy of acupuncture in the treatment of various illness or disorders.
16036720|NCT02619266|Drug|Megestrol Acetate|Megestrol Acetate 160mg tablet
16036721|NCT02619266|Drug|Placebo(Megestrol Acetate)|Starch pill manufactured to mimic Megestrol Acetate 160mg tablet
16036724|NCT02619240|Procedure|bronchoscopy|performance of bronchoscopy with BAL
16036725|NCT02619227|Other|Livelihood intervention|Participants will receive a livelihood intervention package consisting of a orientation and training and a loan package of chickens and associated implements to create poultry microenterprises.
16036726|NCT02619214|Drug|30% of oxygen concentration.|30% oxygen concentration during one hour of general anesthesia.
16036727|NCT02619214|Drug|60% of oxygen concentration.|60% oxygen concentration during one hour of general anesthesia.
16036728|NCT02619201|Drug|Ondansetron|An intravenous dose of ondansetron ( 0.15mg /kg / doses ) .
16036729|NCT02619201|Drug|metoclopramide|An intravenous dose of metoclopramide ( 0.15mg /kg / doses ) .
16036730|NCT02619188|Other|PUQE-form inclusion|PUQE-form encompassing last 24 hours completion
16036731|NCT02619188|Other|Nutritional form inclusion|Food-list form encompassing last 24 hours completion
16036732|NCT02619188|Other|Blood sampling inclusion|Measurement of biochemical nutrition marker(s); Prealbumin
16036733|NCT02619188|Other|Intervention at discharge|PUQE-form, nutritional form and Blood sampling
16036734|NCT02619175|Device|Stroke Subjects Perturbation-Based Balance Training|
16036735|NCT02619175|Device|Stroke Subjects Weight Shifting and Gait training|
16036736|NCT02619162|Drug|Nintedanib|Tablets of 100 mg. or 150 mg.
16036737|NCT02619162|Drug|Letrozole|Tablet of 2.5 mg.
16036738|NCT02619149|Drug|Piperacillin-tazobactam combination product|Piperacillin-Tazobactam (extended-spectrum, beta-lactamase inhibitor) iv peroperatively as prophylaxis
16036739|NCT02619149|Drug|Saline solution|Saline iv as placebo control
16036740|NCT02619136|Procedure|Transfusion|Red Blood Cell Transfusion
16036741|NCT02619123|Other|Tailored screening according to breast density|Different interval of mammography screening according to breast density
16036742|NCT02619123|Other|Annual invitation to mammography|Annual interval mammography screening according to international guidelines for women younger than 50 years old
16036743|NCT02619110|Other|backward walking treadmill training|subjects accepted 30 minutes backward walking treadmill training. a week for four weeks.
16036744|NCT02619110|Other|conventional physical therapy|subjects accepted 30 minutes traditional physical therapy three times a week for four weeks
16036745|NCT02619097|Drug|Pegol-sihematide injection|single dose
16036746|NCT02619084|Procedure|STN DBS|Bilateral STN DBS
16036747|NCT02619071|Procedure|Tumor sampling|Bone marrow aspirate, blood sampling
16036748|NCT02619071|Biological|Constiutional DNA sampling|Buccal swab or Hair follicles
16036749|NCT02619058|Biological|NKT cells|autologous natural killer T cell
16036750|NCT02619045|Other|Telephone follow-up nursing device|"Telephone follow-up nursing device involving:
~telephone appointments made by a dedicated nurse and set up at key stage of treatment (1 phone call per week during chemotherapy cycles),
~specific questionnaire used by the nurse at each phone call (toxicity, general care, quality of life...),
~actions taken for the patient following each phone call (consultation with a doctor, patient hospitalization, sending of a prescription, coordination with the city medical caregiver);"
16036751|NCT02619032|Drug|Remifentanil|Intraoperative continuous infusion of remifenatanil. Remifentanil infusion was interrupted upon completion of surgical intervention.
16036752|NCT02619032|Drug|Fentanyl|Fentanyl 50 μg iv bolus at the induction of anesthesia and before the start of surgery.
16036753|NCT02619019|Drug|Dexamethasone|Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 8 mg of dexamethasone intrathecally
16036754|NCT02619019|Drug|Pethidine|Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 0.2 mg/kg of pethidine intrathecally
16036755|NCT02619019|Drug|Normal saline|Patients will receive 8 mg of hyperbaric bupivacaine 0.5%, plus 2 ml normal saline intrathecally
16036756|NCT02619006|Other|Delayed Cord Clamping or Cord Milking|Healthy term infants who were previously randomized or assigned at birth to the intervention group known as delayed cord clamping. The cord was clamped and cut at or beyond 300 seconds (5 mins). Cord milking (cord milked x 5) was used as a proxy for delayed cord clamping when there was a clinical situation of concern.
16036757|NCT02618993|Procedure|Realization of the V3 block in maxillofacial surgeries|bilateral mandibular block in maxillofacial surgeries
16036759|NCT02618967|Biological|AMG 570|7 dose levels of AMG 570 administered as single dose subcutaneous in healthy volunteers.
16036760|NCT02618967|Biological|AMG 570 Matching Placebo|Placebo administered as single dose subcutaneous in healthy volunteers.
16036761|NCT02618954|Other|Articular ultrasound|(Device : Ultrasound) : Articular ultrasound of the Disease Activity Score (DAS) 28 articular joint
16036762|NCT02618941|Biological|AFFITOPE® PD01A|s.c. injection
16036763|NCT02618915|Genetic|DTX101|solution for IV infusion
16036764|NCT02618902|Biological|tolerogenic dendritic cells (tolDC)|dose-escalation
16036765|NCT02618889|Behavioral|CBT|All participating subjects will start a 12-week CBT treatment program. These consist of weekly 1-hour CBT sessions led by a cognitive therapist. Assessments will be repeated at week 16. All PsyD subjects will undergo a 15-minute, structured diagnostic interview (Mini International Neuropsychiatric Interview (MINI)) developed to screen for axis I DSM-IV and ICD-10 psychiatric disorders. We will also use two clinician-rated instruments to assess comorbid psychopathology in PsyD patients, the 17-item Hamilton Depression Rating Scale (HAM-D), to evaluate for depressed mood, vegetative and cognitive symptoms of depression; and the 14-item Hamilton Anxiety Rating Scale (HAM-A) to evaluate psychic and somatic anxiety. These scales will be administered as part of a structured interview.
16036766|NCT02618876|Drug|Nalbuphine plus Bupivacaine|Addition of caudal Nalbuphine to the standard Bupivacaine
16036767|NCT02618876|Drug|Bupivacaine|Caudal Bupivacaine is the standard of care will be considered as a control
16036768|NCT02618863|Device|Cricoid pressure|Applying cricoid pressure and testing its effectiveness using gastric tube . in addition , by using the cricometer , the CP 50 is defined and compared in both gender
16036769|NCT02618850|Procedure|PET/CT|PET/CT scan at baseline and 10-14 days after day 1 of first cycle chemotherapy
16036770|NCT02618850|Drug|first-line chemotherapy|as prescribed by oncologist
16036771|NCT02618837|Procedure|Downstream strategy|"At diagnosis:
~Subjects receive a loading dose of aspirin (150-300mg). Administration of clopidogrel is allowed only for patients already receiving clopidogrel
~Pre-procedure:
~Until PCI is performed, all subjects will be maintained at a minimum of 75mg of aspirin (Subjects with clopidogrel may be maintained at a minimum of 75mg of clopidogrel)
~Peri- and post-procedure:
~For all the patients undergoing PCI, both the use of unfractioned heparin and of bivalirudin will be allowed at the time of PCI; choice based upon clinical judgement.
~In this case, subject will be randomized in a 1:1 fashion to prasugrel vs ticagrelor
~At the time of PCI, the loading doses required (according to randomization):
~Ticagrelor 180mg, maintained at 90mg b.i.d. for at least 12 months
~Prasugrel 60mg, maintained at a minimum of 75mg of aspirin for at least 12 months plus 10mg of prasugrel* daily for at least 12 months
~If subject is >75 years old or <60 kg, daily dose of prasugrel should be 5mg"
16036772|NCT02618837|Procedure|Upstream strategy|"At the time of diagnosis:
~Subjects randomized in this arm must receive a loading dose of aspirin (150-300 mg) and ticagrelor (180 mg) at admission as soon as possible.
~Pre-procedure:
~All subjects will be maintained at a minimum of 90 mg of ticagrelor b.i.d. and a minimum of 75 mg of aspirin, until coronary angiography is performed.
~Peri- and post-procedure:
~For all the patients undergoing PCI, both the use of unfractioned heparin and of bivalirudin will be allowed at the time of PCI; the choice of the anticoagulant at the time of PCI will be based upon clinical judgement.
~All subjects randomized to the upstream strategy arm will be maintained at a minimum of 90 mg of ticagrelor b.i.d. and a minimum of 75 mg of aspirin, for at least 12 months. If the subject develops hypersensitivity or intolerance to ticagrelor, clopidogrel may be used as a substitute at a dose in accordance with standard hospital practice (to be documented in the eCRF)."
16036773|NCT02618824|Drug|Histidine Tryptophan Ketoglutarate Solution|Hearts will be arrested with Histidine Tryptophan Ketoglutarate (HTK) solution during cardiac operation. After aortic cross clamp 50-60 ml/kg HTK will be administered
16036802|NCT02618525|Other|Supraorbital pressure|Supraorbital pressure is applied by applying pressure over the notch on the inner aspect of eyebrow.
16036774|NCT02618824|Other|Terminal Warm Blood Cardioplegia|Terminal warm blood cardioplegia (TWBC) contains 20% HTK solution and 80% blood from cardiopulmonary bypass machine. Before aortic cross clamp removal 10-15 ml/kg TWBC will be administered with temperature 34-36 oCelcius
16036775|NCT02618785|Procedure|hysterosalpingography|Starting procedure by using largest appropriate speculum for maximum cervical exposure. Cleanse the cervix with povidone iodine. A tenaculum was applied to the anterior cervix to help for stabilization and counter-traction. Then insert a sterile Rubin's cannula into the cervix uteri. A scout radiograph of the pelvis was obtained with the catheter in place before contrast material was instilled. After that the water soluble contrast media was slowly instilled through the cannula appropriate volume range 10-15 ml., with fluoroscopic images obtained intermittently to evaluate the uterus, fallopian tubes and tubal patency
16036776|NCT02618772|Drug|Midazolam|Intranasal administration of midazolam at dose of 0.4mg/kg (max 10 mg) one time 10 minutes prior to laceration repair
16036777|NCT02618772|Drug|Saline|Intranasal administration of saline at a dose of 0.08ml/kg (max 2ml) one time prior to laceration repair as a placebo
16036778|NCT02618759|Drug|DSXS|active treatment
16036779|NCT02618759|Drug|Placebo|placebo treatment
16036780|NCT02618746|Other|Telerehabilitation|
16036781|NCT02618746|Other|Hospital based Rehabilitation|
16036782|NCT02618733|Drug|Ticagrelor|90mg, twice a day
16036783|NCT02618733|Drug|Clopidogrel|75mg, once a day
16036784|NCT02618720|Drug|ornidazole|
16036785|NCT02618720|Drug|Placebo|
16036786|NCT02618707|Other|Lactate|Lactate samples will drawn at specific time points within 5 time intervals: before CPB after induction, during cooling on CPB, during rewarming on CPB, immediately after CPB in the operating room, and after admission to the post-operative intensive care unit.
16036787|NCT02618694|Procedure|Posterior retroperitoneoscopic adrenalectomy|Patient is in prone, half Jack-knife position, and hips and knees are fixed in 75-90°. A 15 mm trocar incision just below the tip 12th rib. Prepare a small retroperitoneal space with finger and insert two 5 mm trocars about 5 cm lateral and medial to the first trocar with digital guidance. Medial trocar will be inserted upward. Lateral one will be lateral and below the 11th rib. Dissect inferior to diaphragm and retraction of the kidney downward. Mobilize the adrenal gland. At right side, start medial and caudally. Control the adrenl arteries crossing the IVC posteriorly. Prepare adrenal vein posterolaterally. Control between two clips. Continue gland dissection laterally and cranially. At left side, prepare the adrenal vein between the gland and diaphragm medial to the upper pole of the kidney. Dissect medial, lateral and cranially. Retrieve the mass through middle incision. Insert a drain and close skin incisions (Walz M. K., 2005).
16036788|NCT02618694|Procedure|Transperitoneal laparoscopic adrenalectomy|On right side, patient is on supine position. Put a trocar at umbilicus for the camera. Put 4 trocars 1-2 cm subcostal from subxiphoid (10-12 mm) for liver retractor, to far lateral (5 mm) and two 10 mm trocars inbetween. Retract liver, incise the retroperitoneum, and identify right adrenal gland between upper pole of the kidney and IVC. Dissect gland from the kidney than laterally and posteriorly from the diaphragm. Expose, apply clips to, and divide the adrenal vein. On left side, patient is on lateral decubitus. Put a trocar at umbilicus for the camera, 4 trocars 1-2 cm subcostal from the midline to the far most lateral possible (the last is 5 mm the rest are 10 mm). Mobilize colon flexure and expose the kidney. Separate kidney from the pancreas and spleen. Mobilize the tumor, starting by posterior surface, superior border then from the renal surface. Divide the adrenal vein. Retrieve the mass (Suzuki, Tsuru, & Ihara, 2012; Linos, 2005; George & Kavoussi, 2010).
16036789|NCT02618668|Drug|Ketamine / Propofol Admixture|propofol-ketamine 3:1 mixture(%1 15 ml propofol + 1 ml 50mg/ml ketamine+4 ml saline in a 20-ml syringe which resulted in0.25 mg.ml-1 ketamine and 0.75 mg.ml-1 propofol
16036790|NCT02618668|Drug|Propofol|2 mg/kg I.V
16036791|NCT02618655|Other|diagnostic methods|explore several laboratory diagnostic methods to find out which will be more helpful for making an accurate diagnosis in the early period of TBDs.
16036792|NCT02618642|Radiation|Irradiations of the biceps brachii muscle with PILER light. The participants were randomized into 4 groups: group v - no filter/ group x - red filter/ group y - blue filter/ group z - placebo.|"Biceps brachii examination was carried out before (examination 1) and after (examination 2) a series of 10 PILER light treatments. It included a traditional electrodiagnostic examination and the assessment of the pressure pain threshold (PPT).
~The electrodiagnostic examination of the muscle was performed using the unipolar stimulation method from the direct motor point. The passive electrode (6 cm x 6 cm) was attached to the side of the distal part of the forearm, and the distal edge of the electrode was adjacent to the proximal edge of the ulnar styloid process. The examination was performed with a Multitronic MT3 electrotherapy apparatus set.
~PPT at the direct motor point was determined using an algometer (Algometer commander TM ITECH Medical Industries). A head with a rubber jacket with a surface area of 0.5 cm2 was used to cause pressure pain. Pressure was exerted until the participant reported pain, at which time the force (lbs) marked by the algometer was recorded."
16036793|NCT02618629|Drug|14C-Z-215|Single oral dose of 20mg Z-215 and 14C-Z-215 solution
16036794|NCT02618616|Drug|ZPL-3893787|
16036795|NCT02618616|Drug|Placebo|
16036796|NCT02618603|Drug|Botulinum toxin A|
16036797|NCT02618603|Drug|Triamcinolone Acetonide|
16036798|NCT02618577|Drug|Edoxaban|"Edoxaban will be applied at the therapeutic dose approved for stroke prevention in non-valvular AF, i.e. 60 mg OD with a reduction of dose to 30 mg OD in patients with one of the following characteristics:
~Impaired renal function (CrCl 15-50 ml/min), or low body weight (≤60 kg), or patients receiving the glycoprotein p inhibitors cyclosporin, dronedarone, erythromycin, or ketoconazole."
16036799|NCT02618577|Drug|ASA|ASA 100 mg tablets or Placebo
16036800|NCT02618564|Drug|Sennosides|Each group will be assigned different doses of sennosides and varying times of administration
16036801|NCT02618551|Procedure|Bronchial thermoplasty for treatment of severe asthma|"Three sessions of bronchial thermoplasty are needed to treat patients. There will be 3 to 4 weeks between each procedure.
~Bronchial thermoplasty procedure is performed under general anesthesia. The medical device used in this research to achieve the thermoplasty is the Alair system (class IIb medical device ; Boston scientific)
~A confocal endomicroscopy will be conducted at the first and final session of thermoplasty. This examination involves analyzing and recording the structure of bronchi microscopy through a small catheter placed on the bronchus. Photographs of the bronchi will be realized."
16040921|NCT02589600|Dietary Supplement|vitamin D|800 IU daily
16036803|NCT02618525|Other|Jaw thrust maneuver|Jaw thrust is performed by placing the index and middle fingers to physically pull the posterior aspects of the mandible upwards while their thumbs push down on the chin to open the mouth.
16036804|NCT02618512|Drug|SBC-103|SBC-103 is a recombinant human alpha-N-acetylglucosaminidase (rhNAGLU). Patients were started with low dose of SBC-103 for 12 weeks and then will escalate to a higher dose.
16036805|NCT02618499|Drug|Timing of administration of post partum Oxytocin|10 IU of oxytocin given IV at different times after birth
16036806|NCT02618486|Procedure|Non surgical periodontal therapy|NSPT includes oral hygiene education, scaling root planing and mouth wash
16036807|NCT02618473|Other|non-seloken|regarding the guidelines patients receive seloken before the cardiac CT scan to lower the heart rate during the scan. The intervention in this study is to avoid the medication with seloken before the scan, and to investigate if the use of a new motion correction scan algorithm can compensate for the absence of the seloken.
16036808|NCT02618460|Device|Non contrast-enhanced magnetic resonance imaging|
16036809|NCT02618447|Device|4Dimensional Phase Contrast Magnetic Resonance Angiography|4D PC MRA is a new non-contrast MRA technique that can measure flow of blood within vessels of interest over time.
16036810|NCT02618447|Procedure|Portal vein embolization|
16036811|NCT02618434|Drug|SPN-810|
16036812|NCT02618434|Drug|Placebo|
16036813|NCT02618408|Drug|SPN-810|
16036814|NCT02618408|Drug|Placebo|
16036815|NCT02618395|Drug|SPARC001A|
16036816|NCT02618395|Drug|SPARC001B|
16036817|NCT02618395|Drug|Reference001 - Hydrocodone|Hydrocodone-acetaminophen
16036818|NCT02618382|Drug|Tranexamic Acid|1300mg tranexamic acid by mouth once before surgery and then three times a day for up to three days or until they are discharged from the hospital, whichever comes first
16036819|NCT02618369|Device|MR-Guided High Intensity Focused Ultrasound|Target treatment of bone lesion using High Intensity Focused Ultrasound
16036820|NCT02618356|Drug|Raltitrexed and S-1|"Raltitrexed 3mg/m2 intravenously guttae, d1 and S-1,bid,po,d1-d14,every three weeks for a cycle.
~BSA (body surface area) S-1 dosage <1.25 m2 80 mg/d
~1.25m2 - <1.5 m2 100 mg/d
~1.5 m2 120 mg/d"
16036821|NCT02618343|Drug|IPA|IPA Aromatherapy for the experimental arm
16036822|NCT02618343|Drug|Ondansetron|Zofran will be administered to the Control arm. This is the drug historically administered by prehospital personnel.
16036823|NCT02618330|Device|retainer|24 h wearing whether 0.75-mm-thick or 1.00-mm-thick film retainer
16036824|NCT02618317|Drug|Heparin Lock Solution|Just after the insertion (since first the hemodialysis session), long-term Central Venous Catheter of CKD 5D patients on high-efficiency hemodialysis have been locked during 15 weeks (100 days) with appropriate lock solution.
16036825|NCT02618317|Drug|Trissodium Citrate 30%|ust after the insertion (since first the hemodialysis session), long-term Central Venous Catheter of CKD 5D patients on high-efficiency hemodialysis have been locked during 15 weeks (100 days) with appropriate lock solution.
16036826|NCT02618317|Drug|Minocycline-EDTA 30 mg/ml - 3 mg/ml|ust after the insertion (since first the hemodialysis session), long-term Central Venous Catheter of CKD 5D patients on high-efficiency hemodialysis have been locked during 15 weeks (100 days) with appropriate lock solution.
16036827|NCT02618304|Drug|Treatment of Meibomian gland dysfunction|artificial tears, 3% Diquafosol Tetrasodium eye drops, steroid eye drops, squeezing of meibomian glands, cleansing of eyelids.
16036828|NCT02618291|Other|Active Geriatric Evaluation (AGE tool)|Yearly administration of the brief assessment tool (BAT). Once the presence of one or more geriatric syndromes is suspected using the brief assessment tool, a management strategy is proposed. It is divided in two distinct steps: 1) perform additional tests to confirm or exclude the diagnosis and 2) to propose specific management attitudes. All proposed attitudes are based on literature review and geriatrician expertise. The FP remains free to follow the proposed attitudes.
16036829|NCT02618291|Other|Usual care|"No specific intervention will be provided to the patients, except what family practitioners (FPs) usually do. In this regard, it is possible that some FPs might use structured interventions similar to the AGE tool. This will be neither encouraged nor discouraged. FPs in the usual care arm will be asked to perform one BAT after 2 years of follow-up, at the final patient visit."
16036830|NCT02618278|Other|Physiotherapy|The aims of physiotherapy are to promote physical and psychological health for the patient, and in doing so promote and improve function. In light of the evidence to suggest spontaneous resorption of the disc fragment occurs, physiotherapy provides support and guidance for the patient to manage their symptoms whilst resorption takes place. The physiotherapy regimen will be tailored to the individuals' requirements. It will be goal orientated, and assessed using a biopsychosocial approach based on 7 different elements; neurological dysfunction, motor control of movement of the lumbar spine and pelvis, movement restriction in the lumbar spine and pelvis, psychological barriers to recovery, advice and education, functional-based exercise and pain.
16036831|NCT02618265|Procedure|Mobile terminal|multiple strategy including mobile terminal based compliance managment, platelet reactivity modified drug adjustment
16036832|NCT02618265|Procedure|traditional management|aspirin or clopidogrel monotherapy or double treatment for
16036833|NCT02618265|Procedure|website platform management|second prevention based on website platform management
16036834|NCT02618252|Device|Zonare|Patients with difficulty IV access are randomized to receive either intervention with ultrasound machine (Zonare ZS3 machine) or the Veinviewer Flex machine.
16036835|NCT02618252|Device|Veinviewer|Patients with difficulty IV access are randomized to receive either intervention with ultrasound machine (Zonare ZS3 machine) or the Veinviewer Flex machine.
16036836|NCT02618239|Dietary Supplement|Bimuno Galacto-oligo-saccharide|
16036837|NCT02618226|Device|Optic nerve ultrasound|Measurement of ONSD with concomitant invasive ICP measurement will be performed at enrollment and at least daily for a total of 7 days. Additional measurements of ONSD may be performed at any time following any decline in Glasgow Coma Scale (GCS) score by 2+ points during the 7 day period.
16036838|NCT02618213|Device|Optiflow Junior|Humified air are dispensed through the system. Airflow, FiO2 (Fraction of inspired oxygen) , SpO2 (peripheral capillary Oxygen saturation) and respiratory rate are noted each hour. Progression of condition might lead to change of system og mechanical ventilation. poor tolerance might lead to change of system
16037269|NCT02615067|Drug|99mTc-MIP-1404 Injection|A single dose of 20 (±3) mCi intravenous (IV) injection of 99mTc-MIP-1404.
16036839|NCT02618213|Device|Continous Positive Airway Pressure|Humified air are dispensed throug the system. Airflow, FiO2, SpO2 and respiratory rate are noted each hour. Progression of condition might lead to change of system or mechanical ventilation. Poor tolerance might lead to change of system.
16036840|NCT02618200|Device|3D prostate ultrasound|
16036841|NCT02618187|Drug|SER-287|
16036842|NCT02618187|Drug|Placebo|
16036843|NCT02618187|Drug|Placebo Pre-Treat|
16036844|NCT02618187|Drug|Vancomycin Pre-Treat|
16036845|NCT02618174|Behavioral|Neutral Control Condition|Message about age of University of Birmingham
16036846|NCT02618174|Behavioral|Food-based Control Condition|Message about variety of vegetables in the world
16036847|NCT02618174|Behavioral|Health Condition|Message about the health benefits of eating vegetables
16036848|NCT02618174|Behavioral|Descriptive Social Norm|Message suggesting most people eat plenty of vegetables
16036849|NCT02618174|Behavioral|Liking Social Norm|Message suggesting most people like eating vegetables
16036850|NCT02618161|Radiation|HDR Brachytherapy|HDR Brachytherapy, a single dose of 15 Gy delivered to prostate
16036851|NCT02618161|Radiation|External beam Radiotherapy|External beam Radiotherapy, a dose of 46 Gy in 23 fractions delivered to prostate
16036852|NCT02618148|Drug|ESTROGEN HERBALS 21|"Applies to the following strengths:
~17β-estradiol 1.5mg/24 hours x 21 days, stop drinking for 7 days. Progesterone 5 mg/24 hours x 10 days, stop drinking for 7 days. Garlic oil 30mg/24 hours x 28 days. Enzyme nattokinase 300 FU x 24 hours x 28 days."
16036853|NCT02618148|Drug|ESTROGEN HERBALS 28|"Applies to the following strengths:
~17β-estradiol 1.5mg/24 hours x 28 days. Garlic oil 30mg/24 hours x 28 days. Enzyme nattokinase 300 FU x 24 hours x 28 days."
16036854|NCT02618135|Other|Intervention Group|Each participant will first need to master a simple concentration task before moving on to play a series of training tasks. An eye gaze tracker connected to the computer will detect the location of eye gaze on the computer screen. The game progresses according to how well the participant can focus their eye gaze on correct objects and sustain their attention. Each task employs the BCI system, and is controlled by the child's concentration. As the child attends to activities on a computer screen, their EEG waves will be recorded simultaneously via the EEG sensors through Bluetooth technology.
16036855|NCT02618135|Other|Control Group|"Participants will wait for 8 weeks before training intervention begins.
~Each participant will first need to master a simple concentration task before moving on to play a series of training tasks. An eye gaze tracker connected to the computer will detect the location of eye gaze on the computer screen. The game progresses according to how well the participant can focus their eye gaze on correct objects and sustain their attention. Each task employs the BCI system, and is controlled by the child's concentration. As the child attends to activities on a computer screen, their EEG waves will be recorded simultaneously via the EEG sensors through Bluetooth technology."
16036856|NCT02618109|Biological|Collection of blood samples|Collection of blood samples
16036857|NCT02618096|Drug|Oxytocin|
16036858|NCT02618096|Drug|Dinoprostone|
16036859|NCT02618096|Procedure|Membrane sweeping|
16036860|NCT02618083|Device|color Doppler ultrasound|pre-operative blood flow velocity measurement with a color Doppler ultrasound device
16036861|NCT02618070|Other|Yogurt|
16036862|NCT02618057|Drug|Prednisolone|PO prednisolone, 1 mg/kg/day, for 5 days
16036863|NCT02618057|Drug|Levofloxacin|Levofloxacin, 10mg/kg/day, IV, for 5days
16036864|NCT02618031|Procedure|Endovascular Treatment (EVT)|EVT is an endovascular procedure in which a catheter is inserted into an artery and directed to the site of the blocked blood vessel in the brain. The clot is removed using a mechanical device with or without an injection of tPA (tissue plasminogen activator) directly at the site of the clot. The protocol calls for use of the Trevo stent retriever (Stryker Neurovascular) for the first pass of clot removal.
16036865|NCT02618018|Procedure|AT TORBI 709M|Cataract surgery with AT TORBI 709M 4-haptic toric IOL
16036866|NCT02618005|Dietary Supplement|Probiotic capsule|Continuously take five capsules containing freeze-dried LcS on ISS for four weeks, from four weeks before the return (R-4W) to one day before the return (R-1d)
16036867|NCT02617979|Other|SAFECARE at Home customized lessons|
16036868|NCT02617966|Device|Medmont Darl Adapted Chromatic (DAC)|uses blue and red light to measure adapted retinal sensitivity to light and is not currently FDA approved for clinical use.
16036869|NCT02617966|Device|RetMap, RM Electrode|used for recording ERGs
16036870|NCT02617966|Device|MonCvONE electrophysiology|electrophysiology unit
16036871|NCT02617953|Device|Active rTMS(A)|"repetitive transcranial magnetic stimulation:1000 stimuli of 1Hz rTMS over the left dorsolateral prefrontal cortex followed by 2000 stimuli of 1 Hz rTMS over the left primary auditory cortex , each consisting of 4 days of rTMS treatment.
~auditory ERP,continuous resting EEG and MRI are measured pre-treatment rTMS and auditory ERP,continuous resting EEG are measured two weeks after rTMS treatment. Tinnitus subjects were asked to perform an interval duration paried pulse task before and after the rTMS train."
16036872|NCT02617953|Device|Active rTMS(B)|"repetitive transcranial magnetic stimulation:1000 stimuli of 1Hz rTMS over the left dorsolateral prefrontal cortex followed by 2000 stimuli of 1 Hz rTMS over the left primary auditory cortex , each consisting of 4 days of rTMS treatment.
~auditory ERP,continuous resting EEG and MRI are measured pre-treatment rTMS and auditory ERP,continuous resting EEG are measured two weeks after rTMS treatment. Tinnitus subjects were asked to perform an interval duration paried pulse task before and after the rTMS train."
16036873|NCT02617953|Device|Sham condition(C)|"The sham stimulation looks and sounds like the active coil, but diverts the magnetic field away from the patient.
~auditory ERP,continuous resting EEG and MRI are measured pre-treatment rTMS and auditory ERP,continuous resting EEG are measured two weeks after rTMS treatment. Tinnitus subjects were asked to perform an interval duration paried pulse task before and after the rTMS train."
16036874|NCT02617940|Other|fissure sealant|"Surfaces allocated to this group will be treated with resin-based sealant (FluroShield®, Dentsply, United States of America) according to the manufacturer's instructions.
~Initially, local anesthesia and rubber dam adaptation will be performed. Then, 37% phosphoric acid will be applied on the surface for 30 seconds, followed by spray of water/air for at least 15 seconds. The sealant will be dispensed on the occlusal surface and light cured for 20 seconds (Optilight Max, Gnatus, Brazil)."
16037312|NCT02614716|Drug|LY3090106|Administered SC
16037313|NCT02614716|Drug|Placebo|Administered SC
16036875|NCT02617940|Other|oral hygiene orientation|Surfaces allocated to this group will be treated with sterile water application, as a placebo, without anesthesia and rubber dam. The active treatment in this group will be only oral hygiene orientations.
16036876|NCT02617914|Procedure|individualized PEEP treatment, Invasive mechanical ventilation, ECMO,|
16036877|NCT02617901|Radiation|Left hand DXA|"All recruited children will have a left hand DXA scan which will be anonymised and from which 3 observers will independently assess bone age according to Greulich and Pyle and TW3 methods on 2 separate occasions at least 4 weeks apart.
~Radiographs and DXA will be read in random and varied order."
16036878|NCT02617888|Radiation|CCTA ~ BREAST SHIELDS|Breast shield placement (randomized) among women.
16036879|NCT02617875|Other|conventional EMS physician|A physically present conventional EMS physician on scene, will treat the patients according to the standard operating procedures.
16036880|NCT02617875|Other|tele-EMS physician|The patients will be treated by the paramedics, which are concurrently instructed by the tele-EMS physicians of the tele consultation center according to the software-based guideline conform algorithms for diagnosis and treatment.
16036881|NCT02617862|Procedure|Examination under anaesthetic (EUA)|The EUA is scheduled as part of the routine clinical management of children with various ophthalmic conditions.
16036882|NCT02617862|Device|RetCam|The RetCam is a pediatric wide-field retinal camera that has been the mainstay for pediatric ophthalmic imaging since 1997. Imaging using the RetCam (during the EUA) is conducted as part of routine clinical magagement.
16036883|NCT02617862|Device|COSMOS|The COSMOS images will be captured (during the EUA) after the RetCam images. The COSMOS is designed to be used in the same way as the RetCam, but to produce higher quality images.
16036884|NCT02617849|Drug|Pembrolizumab|200 mg IV every 3 weeks
16036885|NCT02617849|Drug|Carboplatin|AUC=6, every 3 weeks x 4
16036886|NCT02617849|Drug|Paclitaxel|175 mg/m2, every 3 weeks x 4
16036887|NCT02617823|Procedure|lateral position|patients placed on their left side after epidural catheter insertion
16036888|NCT02617810|Drug|JNJ-42847922|Participants will receive JNJ-42847922 20 milligram (mg) tablet orally once daily from Day 1 to Day 9.
16036889|NCT02617810|Drug|Midazolam|Participants will receive midazolam 4 milligram (mg) syrup orally once on Day 1 during treatment A and on Day 7 during treatment B.
16036890|NCT02617810|Drug|Warfarin|Participants will receive warfarin 25 milligram (mg) tablet orally once on Day 3 during treatment A and on Day 9 during treatment B.
16036891|NCT02617797|Device|Radiofrequecy|The radiofrequency is a noninvasive technique that will be applied to the external urethral meatus region.It will use a digital thermometer with infrared to mention the temperature should reach 39 ° C and maintain this temperature for 2 minutes.It will use a digital thermometer with infrared to mention the temperature should reach 39 ° C and maintain this temperature for 2 minutes
16036892|NCT02617797|Device|Radiofrequency OFF|Will be used to put off radio frequency will be heated glycerin to occur masking for the patient.
16036893|NCT02617784|Drug|Oseltamivir|Oseltamivir will be given as marketed oral suspension, 30 mg after HD or CAPD treatment.
16036894|NCT02617771|Drug|Vitamin D3|from October to March, a Vitamin D oral supplementation (400 UI/die up to 12 month or 600 UI/die beyond 1 year
16036895|NCT02617758|Drug|Fentanyl|Participants will receive single application of DURAGESIC fentanyl transdermal system 100 µg/h dose in one of the treatment periods.
16036896|NCT02617758|Drug|Fentanyl|Participants will receive single application of Fentanyl transdermal system (JNJ-35685-AAA-G021) 100 microgram per hour (µg/h) dose in one of the treatment periods.
16036897|NCT02617745|Other|Platelet level determination|evaluate the predictive value of a biological test performed in the radio-chemotherapy phase in patients suffering from glioblastoma. For this the platelet level will be determined each wek during the radiotherapy phase and each cycle during the chemotherapy phase
16036898|NCT02617732|Drug|Tianqi capsule|"The patients with type 2 diabetes are divided into two groups, one is experimental group, and the other is placebo group.
~The experimental group patients are treated with Tianqi capsule by oral, 5 pills three times a day"
16036899|NCT02617732|Drug|placebo|"The patients with type 2 diabetes are divided into two groups, one is experimental group, the other is placebo group.
~The placebo group patients are treated with placebo by oral, 5 pills three times a day"
16036900|NCT02617706|Device|Epiflo|Transdermal continuous oxygen therapy is oxygen delivery to the wound site directly. Ogenix makes a small portable oxygen concentrator (Trade Name: EPIFLO) that makes continuous transdermal delivery of oxygen possible. It is a 3 ounce oxygen generator that continuously delivers 3 ml of pure oxygen to the wound site.
16036901|NCT02617693|Behavioral|lifestyle intervention|Evaluation of lifestyle intervention combining behavioural change councelling and utilisation of E-health platform. The intervention consists of a combination of behaviour change counselling and support through six contact-points with CHPs (community health promoter) and access to a personalised mobile application.
16036902|NCT02617693|Other|standard antenatal care|Standard of care for pre-pregnancy health. Subjects will be reminded of their endpoint measurement visit towards the end of the intervention period through a phone call.
16036903|NCT02617680|Drug|desflurane - oxygen in air|The manufacturer recommended age-corrected end-tidal concentrations of desflurane in air should be set and achieved initially. Individual EEtC of desflurane will be defined according to entropy parameters and maintained in the targeted range of static and response entropy 40-50
16036904|NCT02617680|Drug|desflurane - oxygen in nitric oxide|The manufacturer recommended age-corrected end-tidal concentrations of desflurane with nitric oxide - oxygen should be set and achieved initially. Individual EEtC of desflurane will be defined according to entropy parameters and maintained in the targeted range of static and response entropy 40-50
16036905|NCT02617667|Drug|Cyclosporine A|topical ocular, eye drops
16036906|NCT02617667|Drug|Placebo|topical ocular, eye drops
16036907|NCT02617654|Drug|Liraglutide|Treatment with liraglutide for 52 weeks
16036908|NCT02617654|Drug|Placebo for liraglutide|Placebo for liraglutide. Treatment once daily for 52 weeks
16036973|NCT02617199|Drug|intravenous analgesia|ketorolac 1mg/kg every 8 hours or metamizol 15 mg/kg every 8 hrs and intravenous opioids (buprenorphine 3 mcg / kg or tramadol 1mg/ kg in continuos infusion
16036974|NCT02617186|Procedure|Video-assisted thoracoscopic surgery|patients randomized to this arm will receive video-assisted thoracic surgery (VATS)
16036909|NCT02617641|Behavioral|TAVIEenM@RCHE|The intervention goal is to increase up to 150 minutes per week of moderate-intensity physical activity through walking. The intervention is underpinned by Strengths-Based Nursing Care that specifies nursing values, and by Self-Determination Theory that specifies variables to tailor the intervention. The four intervention strategies are: 1) Providing information and feedback, 2) Exploring reasons to build motivation, 3) Exploring strengths to build confidence (self-efficacy), and 4) Developing an action plan to maintain motivation and confidence (self-efficacy). The TAVIE system platform is designed to provide a fully automated, easy to navigate website, and the main mode of delivery is video clips of a 'virtual nurse' who presents the tailored intervention content.
16036910|NCT02617641|Behavioral|Publicly available websites|"Le Programme de marche (Institut de Cardiologie de Montréal)
~L'activité physique (Institut de Cardiologie de Montréal)
~L'activité physique (Fondation des maladies du cœur et de l'AVC)
~Directives canadiennes en matiére d'activité physique à l'intention des adultes âgés de 65 ans et plus (Société Canadienne de Physiologie de l'exercice)
~Directives canadiennes en matière d'activité physique à l'intention des personnes âgées de 65 et plus (ParticipACTION)"
16036911|NCT02617628|Drug|extended release naltrexone|Extended Release Naltrexone is currently marketed in the US for use in adults with alcohol dependence. It will be administered in this study at the currently marketed dose of 380 mgs. Subjects will be randomized to receive one injection of 380 mg of extended release naltrexone, at baseline, before they leave the prison, or either 380 mg of extended release naltrexone after they are released from prison. Both groups will receive three additional monthly doses of 380 mgs while enrolled in intensive outpatient treatment for six months. Subjects will also receive weekly psychosocial counseling.
16036912|NCT02617615|Drug|MB-110|MB-110 is a novel, potent, and selective HCV inhibitor against the NS5A protein. In the preclinical studies, MB-110 demonstrated picomolar EC50s towards various genotypes and favorable pharmacokinetic properties to support the once daily dosing regimen.
16036913|NCT02617615|Drug|Placebo|It will be identical in appearance and similar in weight to the MB-110 hard-gel capsule.
16036914|NCT02617602|Procedure|Goal directed therapy|"Based on transpulmonary thermodilution data, the following interventions will be implemented:
~Global end diastolic volume (GEDV) ≤ 430 ml/m2 and extravascular water index (EVWI) ≤ 10 ml/kg: fluid load; GEDV ≥ 550 ml/m2 and EVWI ≥ 10 ml/kg: furosemide;
~cardiac index (CI) ≤ 2 l/min/m2 - inotropic support:
~decreased heart rate (HR): dobutamine, dopamine;
~normal or increased HR: epinephrine, norepinephrine; CI ≥ 2 l/min/m2 and normovolemia: phenylephrine."
16036915|NCT02617602|Other|Control|
16036916|NCT02617589|Drug|Nivolumab|
16036917|NCT02617589|Drug|Temozolomide|
16036918|NCT02617589|Radiation|Radiotherapy|
16036919|NCT02617563|Device|Minimally invasive lumbar fusion|Patients will receive a single or double level instrumented fusion using a minimally invasive/MAST™ PLIF, TLIF, DLIF, OLIF, ALIF or MIDLF surgical procedure with a posterior fixation. For the use of a posterior fixation system, the CD Horizon® Spinal System, is mandatory in this study and will be either mini-open and/or percutaneous.
16036920|NCT02617550|Drug|Vericiguat (BAY1021189)|Vericiguat up-titration from 2.5 mg to 10 mg in an interval of 14 +/- 3 days: 2.5 mg vericiguat for 14 +/-3 days given as 2 x 1.25 mg tablets followed by 5 mg vericiguat for 14 +/-3 days given as 1 x 5 mg tablet followed by 10 mg vericiguat for 14 +/-3 days given as 2 x 5 mg tablets
16036921|NCT02617550|Drug|Placebo|Placebo for 14 +/-3 days given as 1 or 2 tablets [o.d.].
16036922|NCT02617550|Drug|Nitroglycerin|0.4 mg nitroglycerin spray administered at 2.5 hours before treatment (vericiguat [trough] or placebo) on day 12, day 26 and day 40 at 4 hours after treatment (vericiguat [peak] or placebo) on day 13, day 27 and day 41
16036923|NCT02617537|Drug|EE20/DRSP(YAZ,BAY86-5300)|0.02 mg EE (β-CDC)/3 mg DRSP for 24 days and placebo tablets for 4 days per 28-day intake cycle
16036924|NCT02617537|Drug|Placebo|Matching placebo tablets for 28 days per 28-day intake cycle
16036925|NCT02617524|Device|Valve Medical Dedicated Sheath version 00|The Valve Medical Dedicated Sheath is intended to be used as an introducer sheath during BAV procedures
16036926|NCT02617511|Dietary Supplement|Omega-3 Supplementation|
16036927|NCT02617511|Dietary Supplement|Placebo|
16036928|NCT02617498|Device|harmonic scalpel|parenchymal liver transection was performed either by harmonic scalpel after demarcation of line of transection by intraoperative US and doppler.
16036929|NCT02617498|Device|spray mode diathermy|parenchymal liver transection was performed either by spray mode diathermy after demarcation of line of transection by intraoperative US and doppler.
16036930|NCT02617485|Drug|Rituximab|375 mg/m2 IV on day 1 of each 21 days chemotherapy cycle. Number of Cycles: 8.
16036931|NCT02617485|Drug|Doxorubicin|50 mg of doxorubicin per square meter administrated IV on day 1 of each chemotherapy cycle
16036932|NCT02617485|Drug|Vincristine|1.4 mg of vincristine per square meter, up to a maximal dose of 2 mg, administrated IV on day 1 of each chemotherapy cycle
16036933|NCT02617485|Drug|Cyclophosphamide|750 mg of cyclophosphamide per square meter of body-surface area administrated IV on day 1 of each chemotherapy cycle
16036934|NCT02617485|Drug|prednisone|100 mg of prednisone administrated PO per day for five days, day 1-5 of each chemotherapy cycle
16036935|NCT02617472|Device|Pelvic floor exerciser|Daily exercise using the study device
16036936|NCT02617459|Drug|Levobetaxolol eye drops|one drop per time; twice daily
16036937|NCT02617459|Drug|Betaxolol eye drops|one drop per time; twice daily
16036938|NCT02617446|Drug|placebo|
16036939|NCT02617446|Drug|Istaroxime|
16036940|NCT02617433|Device|Inbody|Participant measure muscle mass by bioelectrical impedance analysis (Inbody 720, Seoul, Korea) after fast for eight hours. After measurement, patient is induced anesthesia. Rocuronium dose is 12mg for male, and 9mg for female.
16036941|NCT02617420|Device|Propeller Health Monitoring Device|
16036942|NCT02617407|Drug|Livionex® Dental Gel|Dental Plaque, Gingivitis and Oral Microbiome Control.
16036943|NCT02617407|Drug|PreviDent 5000 plus/Tom's of Maine Children's toothpaste|Dental Plaque, Gingivitis and Oral Microbiome Control.
16036944|NCT02617407|Device|Kolibree Toothbrush|Electric Toothbrush
16036975|NCT02617186|Procedure|Robotic thoracic surgery|patients randomized to this arm will receive robotic thoracic surgery (RTS) with the da Vinci Robot
16036976|NCT02617173|Device|Micro 400 Matrix Therapy Products|Positive electrical current with a low amplitude bellow sensation level situated on the scrotum.
16036945|NCT02617394|Other|Diaphragm scanning - traditional method first|The first (pre-block) diaphragm scan with ultrasound will be done on both sides using the liver (right side) and spleen (left side) as acoustic windows. The second (post-block) diaphragm scan will be done on both sides using a novel method in which lung sliding is used as a guide to identify the diaphragm and quantify diaphragm thickening upon respiration.
16036946|NCT02617394|Other|Diaphragm scanning - novel method first|The first (pre-block) diaphragm scan with ultrasound will be done on both sides using a novel method in which lung sliding is used as a guide to identify the diaphragm and quantify diaphragm thickening upon respiration. The second (post-block) diaphragm scan will be done will be done on both sides using the liver (right side) and spleen (left side) as acoustic windows.
16036947|NCT02617381|Other|questionnaire|assessing the sensitivity and specificity of a simple structured questionnaire
16036948|NCT02617355|Device|Prototype surgical magnetic drape|New prototype surgical magnetic drape made with bottom-isolated ferrite magnets applied to the patient's thorax
16036949|NCT02617355|Device|Green Covidien Magnetic Drape|Green Covidien Magnetic Drape applied to the patient's thorax
16036950|NCT02617355|Device|Jac-Cell Medic Reusable Magnetic Pad|Jaa-Cell Medic Reusable Magnetic Pad applied to the patient's thorax
16036951|NCT02617355|Device|"DeRoyal Magnetic Pad size 20 x 16"|"Magnetic Instrument Pad #25-002, size 20 x 16, DeRoyal Industries Inc applied to the patient's thorax"
16036952|NCT02617355|Device|"DeRoyal Magnetic Pad size 10 x 16"|"Magnetic Instrument Pad #25-001, size 10 x 16, DeRoyal Industries Inc applied to the patient's thorax"
16036953|NCT02617342|Behavioral|Robot-mediated Intervention|The intervention follows the curriculum developed by RoboKind to target and improve upon social interactions through core vocabulary and modeling.
16036954|NCT02617329|Other|Extracorporeal shock wave therapy (ESWT)|The Extracorporeal shock wave therapy (ESWT) was applied on upper trapezius and levator scapulae following parameters 1.5 bar, per intervention 2000 impulse, once a week for three weeks for the experimental group
16036955|NCT02617329|Other|cervical flexion|Education have 8 movement home program for flexion, extension, side bending, rotation in neutral position, and rotation in a position of full cervical flexion.
16036956|NCT02617316|Other|Barefoot|barefoot running test was 20 minutes.
16036957|NCT02617316|Other|In shoes|In shoes test was 20 minutes.
16036958|NCT02617303|Procedure|OTAGO's exercises|The intervention is based on OTAGO's program, consisting of a set of aerobic exercises affecting gait, balance, stability and are adapted for older people to support them both in groups and individually. The program lasts 6 weeks (2 sessions per week) and is followed by a loyalty phase to consolidate the exercise program. Falls and fractures will be monitored quarterly for 15 months.
16036959|NCT02617303|Procedure|COMMON PRACTICE|Normal medical treatment will be provided by family physicians and nurses.
16036960|NCT02617290|Drug|Ticagrelor|Ticagrelor Loading dose of 180mg given after angiography and before PCI , followed by a 30 days treatment with the maintenance dose of 90mg bid.
16036961|NCT02617290|Drug|Clopidogrel|Clopidogrel Loading dose of 300 or 600mg given after angiography and before PCI , followed by a 30 days treatment with the maintenance dose of 75mg per day.
16036962|NCT02617277|Drug|AZD1775|AZD1775 (adavosertib) is available in capsules for oral administration.
16036963|NCT02617277|Drug|MEDI4736|MEDI4736 (durvalumab) will be administered by IV infusion.
16036964|NCT02617264|Procedure|SPOT|Injecting the ink (SPOT) to the axillary lymph node prior the surgery. During the surgery the lymph nodes will be tasted to diagnose the marked node.
16036965|NCT02617251|Other|No intervention|
16036966|NCT02617238|Other|Cardiovascular risk management based on PWV|"Arterial stiffness will be measured through the determination of the carotid-femoral pulse wave velocity (PWV).
~In the PWV group, PWV will be measured at baseline, and then every 6 months. PWV measurement will guide the intensification of treatment. Measurements will be immediately available to the physician in charge of the patient, in order to adapt treatment. The therapeutic strategy is based both on the normalisation of BP and then on the BP-independent reduction in PWV, using commercially available antihypertensive medications.
~In the conventional group, PWV will be measured at baseline, after 2 years, and at the end of the study. PWV values will be masked to the physician"
16036967|NCT02617225|Behavioral|DHaAL Intervention|"This group handwashing program is for rural elementary schools to institutionalize the practice of handwashing before mid-day meal consumption and after use of toilets by harnessing the theory of social peer pressure.
~DHaAL intervention consists of: (1) capacity building of school teachers to implement group handwashing; (2) installing group handwashing station; (3) generating demand among students to wash hands in group; and (4) establishing systems to sustain handwashing infrastructure and behaviors."
16036968|NCT02617225|Behavioral|DHaAL + CFSS Intervention|In addition to support under DHaAL, several intervention schools receive a more holistic and participatory support that focuses on health, safety, nutrition status, and psychological wellbeing of the children, and thus can also influence handwashing practices (and other WASH facilities). CFSS provides capacity building support and establishes systems to improve school environment, learning outcome, teachers capacity, and physical education for children.
16036969|NCT02617212|Procedure|Implant surgery|The volunteers will receive one or two dental implant(s) placed by a surgical procedure, under local anesthesia and careful soft and hard tissue handling. After implant insertion, the volunteers will be randomly assigned to one arm.
16036970|NCT02617212|Device|Three abutment dis-/reconnections.|At the active comparator arm, each implant will receive a titanium healing abutment during the surgery, according to manufacturer's recommendations. Three dis-/reconnections of abutments will be performed after the soft tissue healing period: the first, after 8 weeks, for adjustment of the emergence profile by healing abutment changing; the second, 10 weeks after surgery, for intra-oral prosthetic abutment selection; and the third, 12 weeks after surgery, for the prosthetic abutment definitive connection with the manufacturer recommended torque.
16036971|NCT02617212|Device|No abutment dis-/reconnections.|Each experimental arm implant will receive its definitive prosthetic abutment at the surgical procedure. The manufacturer recommended torque will be applied so that no disconnection of the abutment will occur during and after completion of the treatment. The abutment will receive healing caps, which shall remain in position until the end of 12 weeks after surgery.
16036972|NCT02617199|Drug|Epidural anesthesia|Epidural anesthesia placed at L1-L2 Epidural infusion of ropivacaine 0.2% + 3-4 mcg/ml fentanyl + saline 0.9% (100 ML) 3-5ml/ hr during 120 hours
16036977|NCT02617160|Device|MD-Logic Pump Advisor|Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted using the MD-Logic Pump Advisor
16036978|NCT02617160|Other|Control Group|Insulin pump settings (i.e, basal plan, correction factor, carbohydrate ratio and insulin activity time) will be adjusted by the medical team in accordance to the regular practice
16036979|NCT02617134|Biological|anti-MUC1 CAR-T cells|
16036980|NCT02617121|Drug|Gabapentin|oral gabapentin 300 mg 1 hour before induction of anesthesia
16036981|NCT02617121|Drug|Ramosetron|ramosetron 0.3 mg iv at end of surgery
16036982|NCT02617121|Drug|Gabapentin and Ramosetron|oral gabapentin 300 mg 1 hour before induction of anesthesia and ramosetron 0.3 mg iv at end of surgery
16036983|NCT02617108|Device|Foley balloon|a Foley balloon with 4 ml of normal saline solution will be placed into the uterine cavity at the end of the operation for five days.
16036984|NCT02617095|Device|T2762|One drop in each eye 3 to 6 times daily
16036985|NCT02617095|Device|Optive|One drop in each eye 3 to 6 times daily
16036986|NCT02617082|Radiation|partial breast irradiation|The prescription dose is 40.5Gy in 15 fractions in 3 weeks.
16036987|NCT02617069|Biological|botulinum toxin injection|
16036988|NCT02617069|Biological|0.9% normal saline injection|
16036989|NCT02617069|Device|Implantable loop recorder|
16036990|NCT02617043|Radiation|hypofractionated whole breast irradiation with simultaneously integrated boost|deliver 40Gy/15Fx to whole breast with 48Gy/15fx simultaneously integrated to tumor bed
16036991|NCT02617017|Drug|Buspirone|Capsules of buspirone will be administered orally once a day for 2 weeks (10mg, morning), BID for 2 further weeks (20 mg, morning and evening), TID between weeks 5 and 12 (third intake at noon)
16036992|NCT02617017|Drug|Placebo|Capsules of placebo will be administered orally once a day for 2 weeks (10mg, morning), BID for 2 further weeks (20 mg, morning and evening), TID between weeks 5 and 12 (third intake at noon)
16036993|NCT02616991|Procedure|computed tomography venography|systematically performing computed tomography venography in addition to thoracic computed tomography angiography
16036994|NCT02616965|Drug|Romidepsin|Romidepsin at the dosage 10mg/m2 or 14mg/m2 will be given ONCE 14 days prior to cycle one and then on days 1,8,15 in each cycle. Each cycle is 28 days and treatment will continue up to 16 cycles
16036995|NCT02616965|Drug|Brentuximab vedotin|Brentuximab vedotin at the dosage 0.9mg/kg or 1.2 mg/kg will be given on days 1 and 15 in each cycle. Each cycle is 28 days and treatment will continue up to 16 cycles
16036996|NCT02616952|Dietary Supplement|Chinese herbal therapy|Participants take a Chinese herbal decoction, Yiqi Suoquan Tang, 200ml orally twice a day for 12 weeks. The Yiqi Suoquan Tang are composed of Radix Astragali 30 g, Radix Codonopsis pilosula 10g, Radix Angelica sinensis 10g, Radix Atractylodis Macrocephalae 10g, Fructus Alpiniae Oxyphyllae 10g, Radix Lindera aggregata 6g, Rhizoma Dioscoreae 10g, pericarpium citri reticulatae 10g, Rhizoma Cimicifuga 10g, Radix Bupleuri 10g, Fructus Rubi 15g, and Semen raphani 10g. All the decoctions are provided by the Department of Pharmacy, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, and are packed in opaque plastic bags with 200 ml for each one.
16036997|NCT02616952|Behavioral|Pelvic floor muscle training|In intensive exercises, participants are taught how to identify the muscles: 1) identify anal sphincter/feel anus, and try to raise it from chair (without adding abdominal, thigh, and buttock muscles) with a position of sitting; 2) identify levator ani and try to raise vagina from chair (without adding abdominal, thigh, and buttock muscles) with a position of Sitting, bent forward, elbows on knees; 3) contract levator ani with a position of sitting, lying, and standing; 4) contract anal sphincter with a position of sitting, lying, and standing. Once the participants can identify the muscles, they are asked to do a set consists of 10 contractions, each lasting 5 seconds, with a 5 seconds break between contractions. Then they need to do same procedure 3 times daily as the home exercises.
16036998|NCT02616939|Other|Cardiac CT scanning (with the SpotLight CT)|Cardiac CT scanning
16036999|NCT02616926|Procedure|Hepatic resection|Anatomical surgical resection of the liver including the tumor. Make sure the resection margin is negative during the process.
16037000|NCT02616926|Procedure|TACE|TACE will be performed according to the standard procedure of TACE and will be repeated every four months if needed
16037001|NCT02616926|Procedure|RFA|RFA will be performed 1 week after TACE.
16037002|NCT02616913|Other|R,R-monatin|Each subject consumes test article R,R-monatin (150 mg) in one of 3 treatment periods
16037003|NCT02616913|Other|Moxifloxacin|Each subject consumes moxifloxacin (400 mg; positive control) in one of 3 treatment periods
16037004|NCT02616913|Other|Placebo|Each subject consumes placebo in one of 3 treatment periods
16037005|NCT02616900|Device|eSight Eyewear|primary intervention
16037006|NCT02616887|Radiation|Single dose SBRT and VMAT technique|One fraction of 18 Gy delivered in one day with VMAT and Flattening filter-free (FFF) beams.
16037007|NCT02616874|Drug|MVA.HIVconsv vaccine|Dose: 2x10e8 pfu, Interval: weeks 0 and 9.
16037008|NCT02616874|Drug|Romidepsin|Dose: 5mg/m2 over 4hours, Interval: weeks 3, 4 and 5
16037009|NCT02616861|Drug|IW-1973|IW-1973 Tablet
16037010|NCT02616861|Drug|Matching Placebo Tablet|Matching placebo tablet
16037011|NCT02616848|Drug|Everolimus|
16037012|NCT02616848|Drug|Eribulin|
16037013|NCT02616835|Device|theta-burst TMS|This protocol involves short periods of pulse delivery in combination with long periods of silent intervals.
16037014|NCT02616835|Device|sham theta-burst TMS|This protocol delivers theta-burst pulses from a sham device (i.e. at same speed and timeframe but without the magnetic output)
16037015|NCT02616822|Dietary Supplement|Trans-resveratrol|Used for trans-resveratrol substance 300 mg single dose
16037016|NCT02616822|Other|Placebo|Used for placebo substance single dose
16037017|NCT02616809|Other|Maintaining posture and energy expenditure|Participants will sit continuously for 8-hrs during a simulated office environment
16037018|NCT02616809|Other|Increasing energy expenditure|Participants will cycle slowly while seated in prescribed hourly intervals. This condition will increase energy expenditure while keeping a sitting posture
16037019|NCT02616809|Other|Changing posture|Participants will transition from sitting to standing in prescribed hourly intervals. This condition will change posture (sit to stand) while maintaining low energy expenditure
16038340|NCT02607631|Drug|Pembrolizumab|treated with Pembrolizumab 200 mg every 3 weeks
16037020|NCT02616809|Other|Increasing energy expenditure and changing posture|Participants will transition from sitting to a walking workstation in prescribed hourly intervals. This condition will both increase energy expenditure and change posture.
16037021|NCT02616796|Behavioral|Social gaze training|Appropriate social gaze behavior will be shaped using the principles of Applied Behavior Analysis.
16037022|NCT02616783|Drug|E/C/F/TAF|150/150/200/10 mg FDC tablet administered orally once daily
16037023|NCT02616783|Drug|TDF|300 mg tablet administered orally once daily
16037024|NCT02616783|Drug|FTC|200 mg capsule administered orally once daily
16037025|NCT02616783|Drug|FTC/TDF|200/300 mg tablet administered orally once daily
16037026|NCT02616783|Drug|3TC|Tablet administered orally
16037027|NCT02616783|Drug|Third agent|"Third agent may include one of the following regimens: lopinavir+ritonavir (LPV/r; Kaletra®), atazanavir (ATV; Reyataz®) + ritonavir (RTV; Norvir®), ATV + cobicistat (COBI;Tybost®) (or ATV/COBI FDC), DRV + RTV, darunavir (DRV; Prezista®) + COBI (or DRV/COBI FDC), fosamprenavir (FPV; Lexiva®) + RTV , saquinavir (SQV; Invirase®; Fortovase®) + RTV, efavirenz (EFV;Sustiva®), rilpivirine (RPV;Edurant®), nevirapine (NVP;Viramune®), etravirine (ETR;Intelence®), raltegravir (RAL; Isentress®), elvitegravir (EVG) + COBI, or dolutegravir (DTG;Tivicay®)
~Drug classes:
~Protease inhibitors (PI): LPV/r, ATV, RTV, ATV, DRV, FPV, and SQV
~Pharmacokinetic enhancer: COBI
~Non-nucleoside reverse transcriptase inhibitors (NNRTI): EFV, RPV, NVP, and ETR
~Integrase inhibitors: RAL and DTG"
16037028|NCT02616770|Drug|S1226 (4%)|3 ml Peflubron nebulized, with Medical Gas containing 4% carbon Dioxide, for 2 minutes as a single dose.
16037029|NCT02616770|Drug|Saline (for 4%)|3ml saline nebulized, with Medical Air, for 2 minutes as a single dose
16037030|NCT02616770|Drug|S1226(8%)|3 ml Peflubron nebulized, with Medical Gas containing 8% carbon Dioxide for, 2 minutes as a single dose.
16037031|NCT02616770|Drug|Saline (for 8%)|3ml saline nebulized, with Medical Air, for 2 minutes as a single dose
16037032|NCT02616770|Drug|S1226(12%)|3 ml Peflubron nebulized, with Medical Gas containing 12% carbon Dioxide, for 2 minutes as a single dose.
16037033|NCT02616770|Drug|Saline (for 12%)|3ml saline nebulized with Medical Air for 2 minutes as a single dose
16037034|NCT02616757|Device|Sunlight Omnisense Quantitative Ultrasound|Ultrasound
16037035|NCT02616744|Drug|Ibandronic acid|150 mg per month oral ibandronate
16037036|NCT02616744|Drug|Placebo|1 oral capsule of placebo per month
16037037|NCT02616731|Drug|Tranexamic Acid|use tranexamic acid oral tablets 500 mg two tablets every six hour with the onset of the first day of menstrual cycle till the end of bleeding then The amount of menstrual flow will be calculated by the PBAC
16037038|NCT02616731|Drug|Diosmin|use diosmin oral tablets 500 mg t.d.s (three times daily) with the onset of the first day of menstrual cycle till the end of bleeding.then The amount of menstrual flow will be calculated by the PBAC
16037039|NCT02616718|Radiation|Repeated computed tomography scan of abdomen|Repeated computed tomography scan of abdomen within two weeks prior to surgery or 28-32 weeks after initial scan
16037040|NCT02616692|Drug|Hepatocellular Cancer (HCC) treatments including oral anti-cancer therapy [Nexavar (Sorafenib, BAY43-9006)]|Oral anti-cancer therapy (Sorafenib, an multiple kinase inhibitor), repeated transarterial chemoembolization (TACE) procedures, and hepatic arterial infusion chemotherapy (HAIC)
16037041|NCT02616666|Drug|Dapagliflozin|The product in study is dapagliflozin (FORXIGA™), 10 mg film-coated tablets, and FORXIGA™ should be prescribed according to the instructions in the SmPC and current practice, including up-titration (if considered appropriate by the investigator). Dapagliflozin will be given in combination with metformin.
16037042|NCT02616666|Drug|Standard of Care|The comparator arm consists of SOC. The SOC arm can be sulphonylurea (SU) or non-SU treatments. SU treatments will include any SU and the related insulin secretagogues repaglinide or nateglinide, each of them in combination with metformin. The non-SU treatments can be metformin and dipeptidyl peptidase 4 inhibitors (DPP-4i), or metformin and glitazones (pioglitazone) combination therapy. Other SGLT-2 inhibitors are excluded. All these treatments are approved in the UK for use in this patient population.
16037043|NCT02616653|Procedure|L3-L4 location: Palpation method confirmed by US|An anesthesiologist will locate the L3-L4 space using the palpation method (Tuffier's line). An investigator trained in US imaging will proceed to the US exam of the spine specifically aiming to identify the L3-L4 intervertebral space. The investigator will note if the same level was identified and if not, which one was according to the US exam.
16037044|NCT02616640|Drug|Durvalumab|
16037045|NCT02616640|Drug|Pomalidomide|
16037046|NCT02616640|Drug|Dexamethasone|
16037047|NCT02616614|Drug|Onexton|Topical gel for treating acne
16037048|NCT02616614|Drug|Clindamycin/benzoyl peroxide gel|Generic Clindamycin/benzoyl peroxide gel for treating acne
16037049|NCT02616614|Drug|Placebo|Vehicle gel used as a placebo
16037050|NCT02616601|Drug|Generic Fluorouracil Cream|Topical cream, generic formulation of the brand product.
16037051|NCT02616601|Drug|Carac® (Fluorouracil) Cream|Topical cream, brand product.
16037052|NCT02616601|Drug|Vehicle Cream|Topical cream, placebo. Has no active ingredient.
16037053|NCT02616588|Behavioral|Veteran Patient Navigator and Social Work Intervention|Each study participant will receive a veteran patient navigator intervention which consists of five study visits consisting of advance care planning, pain/symptom management, and education about hospice and palliative care. When clinically indicated, patients will be referred to a social work intervention providing psychosocial care and support.
16037054|NCT02616562|Drug|somapacitan|Administered subcutaneously (s.c., under the skin) once-weekly.
16037055|NCT02616562|Drug|Norditropin® FlexPro® pen|Administered subcutaneously (s.c., under the skin) once daily.
16037056|NCT02616549|Behavioral|Sudarshan Kriya Yoga|A manual-based yoga program featuring a yoga-breathing meditation technique
16037057|NCT02616536|Other|Teaching methods|the two teaching methods will be given to two groups of students and their knowledge gain will be analysed
16037058|NCT02616523|Drug|Dexmedetomidine|The participants will be given infusion of dexmedetomidine 0,5 mcg/kg/h intravenously.
16037059|NCT02616523|Drug|Lidocaine|The participants will be given infusion of lidocaine 1,5 mg/kg/h intravenously.
16037060|NCT02616523|Other|placebo|The participants will be given infusion of normal saline intravenously.
16037314|NCT02614703|Drug|Chromoendoscopy using Acetic Acid 2.5%|Spraying esophageal mucosa during random biopsies for Barrett's esophagus
16037061|NCT02616523|Drug|Fentanyl|Fentanyl 2 mcg/kg will be given to all participants for the intubation and during the operation when ANI value drops below 50.
16037062|NCT02616510|Procedure|cardiovascular screening|cardiovascular screening: serum, urine, ECG, carotid intima media thickness (IMT), cardiac ultrasound
16037063|NCT02616497|Drug|Aspirin|COX-1 inhibitor
16037064|NCT02616497|Drug|Triflusal|COX-1 inhibitor
16037065|NCT02616484|Drug|Dichloroacetate (DCA)|"Study medication DCA is a liquid formulation mixed with an artificial sweetener containing aspartame and strawberry extract (50mg/mL)
~Participants will be genotyped to determine GSTZ1 (glutathione S-transferase Zeta-1) haplotype status, which will stratify this group into 1 of 2 dose regimens:
~EGT carriers will receive 12-14 mg/kg/12hr DCA. EGT non-carriers will receive 6-7 mg/kg/12 hr."
16037066|NCT02616484|Other|Placebo|Participants will receive the same volume of placebo in liquid form given during DCA treatment arm. Liquid will be an exact replication of DCA formulation with no DCA added.
16037067|NCT02616484|Genetic|Genotype|Participants will be genotyped to determine GSTZ1 haplotype status.
16037068|NCT02616471|Dietary Supplement|High-fat cheese|
16037069|NCT02616471|Dietary Supplement|Low-fat cheese|
16037070|NCT02616471|Dietary Supplement|No-cheese/carbohydrate|
16037071|NCT02616458|Other|ear pain counseling|The Ear Pain counseling materials reviewed concepts such as how to recognize ear pain and safely provide pain relief, and how to recognize danger signs that require urgent medical attention. Families were also encouraged to schedule an appointment in the CHC for a possible ear infection rather than going to the emergency department or urgent care facility after hours.
16037072|NCT02616458|Other|language power counseling|The Language Power materials explained the importance of frequent conversations between parents and children and of using encouraging rather than discouraging comments and the PRA reviewed age-appropriate activities in the Learning Games book, and the importance of daily reading using the provided children's book as an example.
16037073|NCT02616445|Drug|UE2343|"UE2343
~10mg, 20, 35mg
~twice daily for 9 days"
16037074|NCT02616445|Drug|Placebo|"10mg, 20, 35mg
~twice daily for 9 days"
16037075|NCT02616445|Drug|Placebo|"Cross-over study
~single dose administered twice (on day 1 and day 8)
~study duration 17 days"
16037076|NCT02616445|Drug|UE2343|"Cross-over study
~UE2343
~single dose administered twice (on day 1 and day 8)
~study duration 17 days"
16037077|NCT02616445|Drug|UE2343|"UE2343
~twice daily for 3 days
~single dose on day 4"
16037078|NCT02616432|Device|Tomosynthesis|Three-dimensional imaging of both breasts in standard CC and MLO views
16037079|NCT02616419|Device|Buzzy® device|Just before the needle-related procedure, the Buzzy®, combining an ice pack and vibration integrated to a plastic bee, will be applied 5 cm above the needle insertion site and will be maintained in place throughout the painful procedure.
16037080|NCT02616419|Drug|Maxilene® (Lidocaine liposomal 4%)|Maxilene® topical anaesthetic cream will be applied 30 minutes before the needle-related procedure at the insertion site.
16037081|NCT02616406|Device|GENEactiv|To wear a monitoring device for a period of time prior to surgery and post surgery
16037082|NCT02616393|Drug|Tesevatinib|
16037083|NCT02616367|Drug|liposomal bupivacaine Periarticular injection|Liposomal bupivacaine used for a periarticular injection in the knee
16037084|NCT02616367|Drug|Ropivacaine Periarticular Injection|Periarticular Injection for the knee with ropivacaine
16037085|NCT02616354|Drug|Imipenem|Patients in group I received a dose of imipenem/cilastatin 1g each every 8 hours or 0.5g every 6 hours optimized two-step infusion therapy (rapid first-step infusion in 30 min and slow second-step infusion above 1.5 hours)
16037086|NCT02616341|Behavioral|Team ERP (T-ERP) Intervention|
16037087|NCT02616341|Behavioral|Treatment as Usual (TAU)|
16037088|NCT02616328|Other|No intervention|No intervention administered in this study
16037089|NCT02616315|Drug|Naltrexone HCl/Bupropion HCl Placebo|Naltrexone/bupropion placebo-matching tablets
16037090|NCT02616315|Drug|Naltrexone HCl/Bupropion HCl|Naltrexone HCl 8 mg/bupropion HCl 90 mg tablets
16037091|NCT02616302|Drug|Dexlansoprazole|Dexlansoprazole 15 mg, 30 mg, and 60 mg capsules
16037092|NCT02616289|Other|Topical emollient (Sun Flower seed oil)|3 g of oil per kg of infant's weight at study entry of Sunflower Seed oil (SSO) will be applied three times per day at regularly spaced intervals (8-hour intervals) for 10 days. Oil will not be applied to the face (to avoid the possibility of any accidental aspiration or ingestion), ears or under the hairline. Care will be taken to not injure the skin during the massage treatment. The child's anal area will be washed prior to application to avoid the spread fecal flora from the anal region (to which the oil will be applied to last). Prior to bathing the child a minimum of 3-4 hours should have elapsed following the application of the SSO. The amount of oil required will be calculated based on the child's weight and the required amount weighed out each time.
16037093|NCT02616276|Other|Control breakfast|It consists of 350 ml of water at room temperature.
16037094|NCT02616276|Other|High glycemic index breakfast|It consists of 350 ml of water at room temperature, 200 ml of grape juice (with 136.28 kcal), 40 g of white bread (2 slices of 52.2 kcal each) and 29 g of strawberry jam (with 127.52 kcal); providing a total of 368.2 kcal.
16037095|NCT02616276|Other|Low glycemic index breakfast|It consists of 350 ml of water at room temperature, a 150 g apple (with 81.12 kcal), a 125 g low-fat natural yogurt (with 56.10 kcal), 3 shelled walnuts (with 38.94 kcal per unit) and 17.5 g of 72% black chocolate (with 102 kcal); supplying a total of 356.04 kcal.
16037096|NCT02616263|Other|Foot exercise|
16037097|NCT02616263|Other|Shoulder exercise|
16037098|NCT02616250|Drug|Brimonidine 0.33% gel (Br)|
16037099|NCT02616250|Other|CD07805/47 (Br) placebo gel|
16037100|NCT02616250|Drug|Ivermectin 1% cream (IVM)|
16037101|NCT02616250|Other|CD5024 (IVM) placebo cream|
16037102|NCT02616237|Behavioral|Lifestyle Intervention|East-meets-West Lifestyle Intervention elements include nutrition and exercise from the Western perspective, food therapy and acupressure from the Traditional Chinese Medicine perspective, self-monitoring, and motivational videos of successful stories from working colleagues. The group participants in the Facebook are encouraged to post their health behaviors and questions, self-monitor, pledge for weight loss, seek social support and interact with health partners and other participants.
16037103|NCT02616224|Other|No intervention|No intervention was administered in this study.
16037104|NCT02616198|Other|EquiaFil G-coat|The old restorations or new caries were removed with anaesthetic solutions when necessary, a matrix was applied for two surface cavities and the restoration was performed with EquiaFil in bulk after mixing 10 sec. in the mixing machine. After 2min 30 sec, the restoration was contoured and the occlusion adjusted.Then the surface was coated with G-coat and light cured for 10 sec. The restorations were controlled by 2 independent examiners at baseline, 6-12-18 months and 6 years according to the United State Public Health Service criteria.
16037105|NCT02616198|Other|EquiaFil Fuji Varnish|The old restorations or carious lesions were removed with anaesthetic solutions when necessary, a matrix was applied for two surface cavities and the restoration was performed with EquiaFil in bulk after mixing in the mixing machine. After 2min 30 sec, the restoration was contoured and the occlusion adjusted.Then the surface was coated in 2 layers of Fuji Varnish. The restorations were controlled by 2 independent examiners at baseline, 6-12-18 months and 6 years according to the United State Public Health Service criteria.
16037106|NCT02616198|Other|Riva SC G-coat|The old restorations or carious lesions were removed and a sectional matrix was applied for two surface cavities and the restoration was performed with Riva SC in bulk after mixing 10 sec. in the mixing machine. The glass ionomer was packed with hand instruments in the cavities and 2min after the first setting the restoration was contoured and the occlusion adjusted.Then the surface was coated with G-coat resin and light cured for 10 sec. The restorations were controlled by 2 independent examiners at baseline, 6-12-18 months and 6 years according to the United State Public Health Service criteria.
16037107|NCT02616198|Other|Riva SC Fuji Varnish|The caries lesions were removed with diamond and stainless steel burs, a sectional matrix was applied for restoring two surface cavities and the restoration was performed with Riva SC in bulk after mixing 10 sec. in the mixing machine. After the first setting of 2min, the restoration was contoured and the occlusion adjusted.Then the surface was coated in 2 layers with Fuji Varnish. The restorations were controlled by 2 independent examiners at baseline, 6-12-18 months and 6 years according to the United State Public Health Service criteria.
16037108|NCT02616185|Biological|PF-06755992|PF-06755992 will be administered on Day 1 of Cycles 1 and 2.
16037109|NCT02616185|Biological|PF-06755990|PF-06755990 will be administered using a device on Day 29, 57 and 85 of each cycle.
16037110|NCT02616185|Device|TDS-IM Electroporation Device|TDS-IM electroporation device and associated supplies will be used for PF-06755990 administration
16037111|NCT02616185|Biological|Tremelimumab|PF-06753388 will be administered every 28 days.
16037112|NCT02616185|Biological|PF-06801591|PF-06801591 will be administered every 28 days.
16037113|NCT02616185|Biological|PF-06753512|Combination of adenovirus (AdC68) + plasmid DNA (pDNA) + tremelimumab
16037114|NCT02616172|Genetic|Autologous Bone Marrow Infusion|The subjects autologous bone marrow cells harvested at Florida Hospital will be infused intravenously by gravity
16037115|NCT02616159|Other|Oatmeal|
16037116|NCT02616146|Drug|ENG-E2 125 μg/300 μg vaginal ring|Up to 13 cycles of ENG-E2 125 μg/300 μg administered intravaginally, each cycle consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
16037117|NCT02616146|Drug|LNG-EE 150 μg/30 μg COC|Up to 13 cycles of LNG-EE 150 μg/30 μg administered orally, each cycle consisting of one tablet per day for 21 days, followed a 7-day tablet-free interval.
16037118|NCT02616133|Other|chart abstraction|abstraction of breast cancer patients with de-identified data
16037119|NCT02616120|Drug|SQJZ herbal mixtures|The SQJZ herbal mixtures is Chinese herb extracts. It contains Rehmannia glutinosa Libosch，Astragalus membranaceus (Fisch.) Bunge etc.( 29.375g, 2 times per day)
16037120|NCT02616120|Drug|Placebo|placebo contains 5%SQJZ herbal mixtures and 95% dextrin,identified to SQJZ herbal formula (29.375g, 2 times per day)
16037121|NCT02616107|Other|Managing Cancer Care: A Caregiver's Guide|"MCC-CG is a set of 7 printed modules including information about caregiver-nominated SM topics, conversation starters to facilitate communication with patients and providers, and links to caregiver resources. The modules are as follows:
~Becoming a Cancer Caregiver [role, changes, challenges, adjusting, self-care]
~Basics of Cancer Caregiving [physical, functional, emotional, social, & spiritual support; treatment timeline worksheet]
~Caregiver's Role in Managing Patient Care [who/what is involved; health care professionals worksheet]
~Managing Cancer Symptoms and Side Effects [common symptoms/side effects; maintaining health; nutrition & exercise; medication management worksheet]
~Care Options: [information on curative, palliative and hospice care]
~Talking About Goals of Care [information on goals of care conversations]
~Managing Transitions [defining transitions, transition examples, helping yourself and patient to manage transitions; transitions worksheet]"
16037122|NCT02616107|Other|Symptom Management Toolkit|Along with an overview of symptom management, the Toolkit provides concise information on commonly experienced symptoms, including fatigue, alopecia, cognitive dysfunction, nausea and vomiting, and sleep problems, among others. Each chapter uses a question-and-answer format to cover the topics of who is most likely to experience the symptom, when and why the symptom may occur, how the symptom can be managed, and when to call a provider. Drs. Schulman-Green and McCorkle have previously tested the Symptom Toolkit in an attention-control group.
16037123|NCT02616094|Device|Multi-method Neuroendocrine and Neuroimaging Procedure Scan 1|The MRI scan will be conducted on a 3-T Siemens Trio MRI system equipped with a standard quadrature head coil, using T1 MPRAGE sequence for structural scanning and T2*-sensitive gradient-recalled single shot echo planar pulse sequence for functional scans. Two multimethod MRI scans will be conducted in the AD sample, while the controls will participate in a single scan.
16037124|NCT02616094|Device|Multi-method Neuroendocrine and Neuroimaging Procedure Scan 2|The MRI scan will be conducted on a 3-T Siemens Trio MRI system equipped with a standard quadrature head coil, using T1 MPRAGE sequence for structural scanning and T2*-sensitive gradient-recalled single shot echo planar pulse sequence for functional scans. Two multimethod MRI scans will be conducted in the AD sample, while the controls will participate in a single scan.
16037125|NCT02616081|Other|Clean Intermittent Catheterization|Clean intermittent self catheterization is a standard of care.
16037126|NCT02616081|Other|Indwelling Catheter|Indwelling catheterization is a standard of care.
16037127|NCT02616081|Other|Bladder Surgery|Bladder surgery is a standard of care.
16037128|NCT02616068|Drug|Transdermal Patch|Transdermal patch 100 mg once a day for 7 days
16037129|NCT02616068|Drug|Loxoprofen sodium|Loxoprofen sodium 60 mg per tablet by mouth, every 8 hours for 7 days
16038341|NCT02607618|Drug|Iclaprim|Experimental treatment
16037130|NCT02616068|Drug|Placebo (for loxoprofen sodium)|Placebo (for loxoprofen sodium 60 mg per tablet) by mouth, every 8 hours for 7 days
16037131|NCT02616068|Drug|Placebo (for transdermal patch)|Placebo (for transdermal patch 100 mg) once a day for 7 days
16037132|NCT02616055|Drug|tesevatinib|
16037133|NCT02616042|Other|Centella asiatica and bamboo salt|Participants uses three types of dentifrices for four days after each wash-out period of 10 days. Dentifrice with Centella asiatica and bamboo salt is compared with control dentifrice.
16037134|NCT02616042|Other|Centella asiatica|Participants uses three types of dentifrices for four days after each wash-out period of 10 days. Dentifrice with Centella asiatica is compared with control dentifrice.
16037135|NCT02616029|Drug|E/C/F/TAF|150/150/200/10 mg FDC tablets administered orally once daily
16037136|NCT02616016|Device|MRI Guided High Intensity Focused Ultrasound|Target treatment of bone metastases using High Intensity Focused Ultrasound
16037137|NCT02616003|Drug|Liraglutide|Initially 1.2 mg Liraglutide as subcutaneous daily injection, boosted to 1.8 mg Liraglutide after 3 days subsequently. 1000 ml infusion of aminosteril hepa 8% from day 1 onwards. Caloric diet with 800 kcal from day 1 onwards till technical operability is achieved (about 21 days)
16037138|NCT02616003|Other|Aminosteril hepa 8%|Initially 1.2 mg Liraglutide as subcutaneous daily injection, boosted to 1.8 mg Liraglutide after 3 days subsequently. 1000 ml infusion of aminosteril hepa 8% from day 1 onwards. Caloric diet with 800 kcal from day 1 onwards till technical operability is achieved (about 21 days)
16037139|NCT02616003|Dietary Supplement|Caloric diet with 1000 kcal|Initially 1.2 mg Liraglutide as subcutaneous daily injection, boosted to 1.8 mg Liraglutide after 3 days subsequently. 1000 ml infusion of aminosteril hepa 8% from day 1 onwards. Caloric diet with 1000 kcal from day 1 onwards till technical operability is achieved (about 21 days)
16037140|NCT02615990|Device|Erigo Pro|Verticalization table with two integrated robotic devices for leg movement and cyclic loading
16037141|NCT02615990|Other|Standard Physical Therapy|Patients receive standard physical therapy.
16037142|NCT02615977|Behavioral|Zooming Joystick Task|"Subjects are instructed to use the joystick to pull all pictures (alcoholic and non-alcoholic beverages) towards them that appear in the portrait format, while pictures in a landscape format are pushed away. Half of the pictures are alcohol-related and the other half is not. The assignment of stimuli (alcohol versus neutral) to the picture format (portrait versus landscape) is manipulated (see 'Study Arm' descriptions).
~Arousal and valence of the alcohol and non-alcohol pictures is rated as previously described. The investigators will apply six sessions of ZJT training, as this number has been proven sufficient for reducing relapse rates."
16037143|NCT02615977|Behavioral|Zooming Joystick Task (Placebo)|"Subjects are instructed to use the joystick to pull all pictures (alcoholic and non-alcoholic beverages) towards them that appear in the portrait format, while pictures in a landscape format are pushed away. Half of the pictures are alcohol-related and the other half is not. The assignment of stimuli (alcohol versus neutral) to the picture format (portrait versus landscape) is manipulated (see 'Study Arm' descriptions).
~Arousal and valence of the alcohol and non-alcohol pictures is rated as previously described. The investigators will apply six sessions of ZJT training, as this number has been proven sufficient for reducing relapse rates."
16037144|NCT02615964|Radiation|Nova Flow Procedure|Evaluation of the diagnosis, and stratification of the severity of Raynaud's disorder in patients with scleroderma based on clinical and imaging data will allow creation of more precise diagnostic criteria as well as disease classification which may guide treatment practices. The study results will likely have no immediate benefit to the patients participating in the study, however may have a future impact diagnosis, stratification and ultimately treatment of patients with Raynaud's disorder. In addition, data collected in this study may provide insight into disease process and leading to future research endeavors.
16037145|NCT02615951|Other|blood sampling|Blood sample retrieval for biological and genetic analysis and comparison
16037146|NCT02615938|Drug|Hydroxychloroquine sulfate|Apply drug to modify lysosomal pH
16037147|NCT02615938|Other|Placebo|Apply Placebo not to modify lysosomal pH
16037148|NCT02615925|Other|Psychiatry Consultation|Psychiatry Consultation
16037149|NCT02615912|Other|PEG-40 Hydrogenated Castor Oil (Tagat CH40, Evonik) 1.5%|
16037150|NCT02615912|Other|Lauryl glucoside (Plantacare® 1200UP, BASF) 1.5%|
16037151|NCT02615912|Other|Sorbitan palmitate (SPANTM 40 (powder), Croda) 1.5%|
16037152|NCT02615912|Other|Silwet* DA-63 (Momentive) 1.5%|
16037153|NCT02615912|Other|Sodium lauryl sulfate (Sigma Aldrich) 1.0%|
16037154|NCT02615912|Other|Water (control)|
16037155|NCT02615899|Other|Matched: Targeted (specific) balance exercise interventions|
16037156|NCT02615899|Other|Mismatched: Untargeted (non-specific) balance exercise interventions|
16037157|NCT02615886|Other|Observational Control|Participants will be observed and not provided any dietary supplementation.
16037158|NCT02615886|Dietary Supplement|Rice bran|Dietary rice bran consumed daily and amounts increase throughout the 6 month intervention (6 months of age: 1 g/day rice bran, 7 months: 2 g/day rice bran, 8 months: 2 g/day, 9 months: 3g/day, 10 months: 4g/day, 11 months: 5g/day).
16037159|NCT02615873|Drug|Accordion Pill™ Carbidopa/Levodopa|Accordion Pill™ Carbidopa/Levodopa Capsule 50/400mg , b.i.d or t.i.d or Accordion Pill™ Carbidopa/Levodopa Capsule 50/500mg , b.i.d or t.i.d
16037160|NCT02615860|Other|Topical 85% trichloroacetic acid (TCA)|In the experimental intervention arm, all visible lesions are treated with 85% TCA by dipping the wooden stick end of a cotton swab into a cup containing TCA. The stick end is saturated with TCA and is inserted through the anoscope and directed to the lesion under HRA guidance. TCA is applied to the lesion repeatedly until the lesion changes to a dense white colour. Each TCA application session is followed by another appointment four weeks later, where the clinician re-evaluates the lesions of the patient and determines whether a next TCA application is necessary up to a maximum of four times
16037161|NCT02615860|Procedure|Surgical electrocautery (ECA)|In the control arm, HRA-guided ECA, is performed every 4 weeks up to a maximum of four times. All visible lesions are ablated at every visit. Bleeding from small vessels can be stopped by ECA. Patients undergo local anaesthesia if necessary
16037162|NCT02615847|Drug|Memantinhydrochlorid|"Memantin Mepha® Lactabs (memantinehydrochlorid) will be provided as 5 mg, 10 mg, 15 mg and 20 mg tablets, packed in blister.
~The study drug will be taken once a day per os, during 12 month."
16038342|NCT02607618|Drug|Vancomycin|Active comparator
16037163|NCT02615834|Procedure|Gentle chest pressure|Gentle pressure on the patient's right chest will be applied to achieve 12 breaths per minute.
16037164|NCT02615821|Behavioral|Mental Contrasting|n the mental contrasting activity participants will be asked by the researcher to consider the best outcome associated with engaging in physical activity, as well as the obstacles they may encounter while completing the activity. The first question will ask participants to name the most positive outcome of realizing their goal (e.g., feeling more awake during classes; weight loss). The second question will ask participants to name the most critical obstacle (e.g., feeling tired; rain) to reaching their goal.
16037165|NCT02615808|Other|Oxygen saturation data visualization|The data visualization contains current and recent (over last 4, 8 or 12 hours) pulse oximetry readings and trends as well as the monitor alarm limits and most recently recorded supplemental oxygen content and flow.
16037166|NCT02615795|Device|Tele Monitoring, using Tunstall monitoring device|Monitoring of symptoms and physiological parameters at home, using Tunstall Healthcare telemedicine equipment. Patients perform physiological measurement. In addition, they correspond to a standardized questionnaire regarding disease specific symptoms. Data is assessed by the medical staff the same day. If the data indicates worsening in the patient's condition, the patient is contacted by phone. The assessment of the patient is made either on the specialist nurse level, or at a conference between the specialist nurse and a senior pulmonary doctor. There is no call center service.
16037167|NCT02615782|Drug|CKD-397|CKD-397 1T single oral administration under fasting condition or fed condition(high fat meals)
16037168|NCT02615769|Behavioral|focused information of spirometry in the invitation|Focused information of spirometry in the invitation to the preventive health check compose the intervention in this trial.
16037169|NCT02615769|Behavioral|standard invitation|The active comparator will receive a standard invitation to the preventive health checks. The preventive health checks in the active comparator group and the intervention group are identical.
16037170|NCT02615756|Behavioral|Exercise|
16037171|NCT02615743|Behavioral|Daily Text message reminder|Subjects in the intervention arm will receive once daily text messages at the time of their choice or at a default time of 7am. The text message will remind them to give their child their controller medication and provide a helpful information on asthma controller use.
16037172|NCT02615743|Device|Inhaled steroid canister monitor|An electronic monitor will be affixed to subjects' inhaled steroid canister and families will be instructed to use the inhaler as directed by their physician. Subjects will not receive daily text messages.The canister monitor, the Propeller sensor (Propeller, Madison, Wisconsin) is an FDA-approved, portable device which affixes to the top of most metered dose inhaler canisters. The devices records the number and time of each inhaler actuation and transmits this information to either a smart phone or cellular modem. Data is then sent via the cellular network to the secure Propeller server. The data will then be downloaded monthly.
16037173|NCT02615730|Drug|GSK2636771|Increasing dose levels of GSK2636771 (300 mg or 400 mg once daily)
16037174|NCT02615730|Drug|Paclitaxel|fixed dose of paclitaxel (80 mg/m2 on Days 1, 8 and 15 of a 28-day treatment cycle)
16037175|NCT02615717|Behavioral|Attention Bias Modification|comparison of treatment versus control
16037176|NCT02615704|Device|Active group with MEMS|Patients treated with twice daily Brilique (ticagrelor) co administered with low dose of acetylsalicylic acid with APP as support tool and with MEMS
16037177|NCT02615704|Device|Active group without MEMS|Patients treated with twice daily Brilique (ticagrelor) co administered with low dose of acetylsalicylic acid with APP as support tool but without MEMS
16037178|NCT02615704|Device|Control group with MEMS|Patients treated with twice daily Brilique (ticagrelor) co administered with low dose of acetylsalicylic acid without APP as support tool but with MEMS
16037179|NCT02615704|Device|Control group without MEMS|Patients treated with twice daily Brilique (ticagrelor) co administered with low dose of acetylsalicylic acid without APP as support tool and without MEMS
16037180|NCT02615691|Biological|PEGylated Recombinant Factor VIII|Polyethylene glycol (PEG)-ylated full-length recombinant FVIII (rFVIII).
16037181|NCT02615691|Biological|ITI|Immune tolerance induction therapy
16037182|NCT02615678|Device|Acupuncture|Acupuncture twice a week for 6 weeks then one treatment a week for 4 weeks. Total 16 treatments in 10 weeks.
16037183|NCT02615665|Procedure|Hepatic resection|Removal of a part of the liver during surgery
16037184|NCT02615652|Other|no intervention|no intervention, observational study
16037185|NCT02615639|Biological|HPDC-T cells & Entecavir|experimental groups will be given HPDC-T cells & Entecavir. HPDC-T cells will be given for 24weeks on the basis of anti-HBV therapy ,and entecavir 0.5mg tablet every night by mouth
16037186|NCT02615639|Drug|Entecavir|0.5mg tablet every night by mouth
16037187|NCT02615639|Drug|HPDC-T cells & IFN-a-2a|experimental groups will be given HPDC-T cells & IFN-a-2a. HPDC-T cells will be given for 24 weeks on the basis of anti-HBV therapy ,and IFN-a-2a 180ug subcutaneous injection every week
16037188|NCT02615639|Drug|IFN-a-2a|IFN-a-2a 180ug subcutaneous injection every week
16037189|NCT02615639|Drug|HPDC-T cells & Telbivudine|experimental groups will be given HPDC-T cells & Telbivudine. HPDC-T cells will be given for 24weeks on the basis of anti-HBV therapy ,and Telbivudine 600mg tablet every day by mouth
16037190|NCT02615639|Drug|Telbivudine|Telbivudine 600mg tablet every day by mouth
16037191|NCT02615626|Procedure|Non-surgical Periodontal Treatment.|Non-surgical periodontal therapy is an anti-infective therapy which includes both mechanical and chemotherapeutic approaches to minimize or eliminate microbial biofilm, the primary etiology of gingivitis and periodontitis
16037192|NCT02615613|Other|Low Acceptability Meal|
16037193|NCT02615613|Other|High acceptability meal|
16037194|NCT02615600|Device|lf-tRNS|Low-frequency tRNS (Neuroconn, Eldith DC-Stimulator Plus): <100Hz, 2mA, 20min, 10s ramp time, left and right auditory cortex, 5x7cm electrode with the inferior middle part over T3/T4
16037195|NCT02615587|Drug|Standard of care in AF in Denmark|As used in clinical practice, analysed as per drug class, not separate drugs.
16037196|NCT02615574|Biological|αDC1 vaccine|Subjects will receive one cycle of CKM alone followed by three cycles of vaccine + CKM.
16037197|NCT02615574|Drug|CKM|Subjects will receive one cycle of CKM alone followed by three cycles of vaccine + CKM.
16037266|NCT02615106|Radiation|21.6Gy/12Fx to the tumor bed and 36Gy/20Fx to the tumor|21.6Gy/12Fx to the tumor bed and 36Gy/20Fx to the tumor
16037198|NCT02615561|Device|Bepanthen Itch Relief Cream: Phoenix 2 (Bepanthen Sensiderm, BAY207543)|2-3 times daily using multiples of Finger Tip Units (FTUs) depending on size of the area of the flares
16037199|NCT02615561|Other|New cosmetic Bepanthen product: Pumpkin (BAY207543)|Twice daily on the whole body; about 10 FTUs (i.e. 5g) per application depending on age of subject
16037200|NCT02615561|Other|Stelatopia (cosmetic comparator)|Twice daily on the whole body; about 10 FTUs (i.e. 5g) per application depending on age of subject
16037201|NCT02615548|Other|community-based exercise class|This intervention will be held in a community centre, twice per week, for 36 weeks.The participants will have an educational session regarding importance of regular exercise.The class will consist of evidence-based exercises such as: sustained, high effort exercises, resistance exercises, and endurance training.Two trainers with specific for Parkinson Disease training will lead the class.
16037202|NCT02615548|Other|self-directed physical activity|Participants from this group will have an educational session regarding importance of regular exercises for Parkinson Disease and will be asked to stay as active as possible.Both groups will be asked to fill out physical activity diary.
16037203|NCT02615535|Device|EEG neurofeedback-assisted meditation|meditation with auditory feedback regarding EEG status
16037204|NCT02615535|Device|Non-EEG feedback-assisted meditation|meditation without auditory feedback regarding EEG status
16037205|NCT02615522|Device|BPK-S Integration|
16037206|NCT02615509|Radiation|Imaging on experimental tomo device|The system used for imaging in the experimental arm is the Philips MicroDose tomography system. The system used for imaging in the active comparator is a standard FFDM system
16037207|NCT02615496|Behavioral|Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)|Survey to measure physician awareness and understanding of the key messages in the educational materials: the prescriber guide and video.
16037208|NCT02615496|Behavioral|Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)|"Survey to measure patient awareness and understanding of the key messages in the educational materials: the patient booklet Your guide to EYLEA, patient information leaflet, and audio CD."
16037209|NCT02615483|Other|Web-based platform|"The WP is based on a conducted literature review and results form a previous study conducted in the regional context of the study. Information on the WP is animated based on the current literature stating that educative animation video optimises patients' acquisition of knowledge. The intention is to offer the patients the advantages in gaining knowledge in familiar surroundings and at a pace matching their needs and wishes.
~The WP contains animated and written information mirroring the course of treatment, frequently asked questions and answers, it contains animated training support, a diary in order to keep track of training and development of pain and finally a social feature, a web-café."
16037210|NCT02615470|Behavioral|Enhanced immunization delivery model|Webinar and online training will be delivered to intervention pharmacist-technician pairs to discuss strategies that can be used to enhance immunization delivery model and how to integrate the new model into their routine practice. This intervention also includes feedback from immunization experts for the period of 6 months.
16037211|NCT02615470|Other|Immunization update|Basic immunization update online webinar will summarize changes in immunization schedules.
16037212|NCT02615457|Drug|Huaier Granule|Huaier Granule was given orally, 20 g tid for 5 years.
16037213|NCT02615444|Dietary Supplement|Beta-glucan enriched oatcake|5 oatcakes enriched with oat beta-glucan will be consumed daily for six weeks
16037214|NCT02615444|Dietary Supplement|Isocaloric control|6.5 wheat based control snacks without beta-glucan will be consumed daily for six weeks
16037215|NCT02615431|Other|MitraClip Intervention|
16037216|NCT02615418|Device|NIBS system for evaluation and treatment utilizing non invasive brain stimulation|
16037217|NCT02615405|Dietary Supplement|EPA|A daily treatment of 5 identical capsules of EPA (3.5 g/d) for Studies 1 & 2.
16037218|NCT02615405|Dietary Supplement|DHA|A daily treatment of 5 identical capsules of DHA (1.75 g/d) for Studies 1 & 2.
16037219|NCT02615405|Dietary Supplement|Placebo|A daily treatment of 5 identical capsules of placebo (high oleic oil) in single or divided administration for Study 1.
16037220|NCT02615392|Behavioral|Park Prescription|Please refer to the information included in the arm description.
16037221|NCT02615379|Device|EPIFLO|Transdermal continuous oxygen therapy is oxygen delivery to the wound site directly. Ogenix makes a small portable oxygen concentrator (Trade Name: EPIFLO) that makes continuous transdermal delivery of oxygen possible. It is a 3 ounce oxygen generator that continuously delivers 3 ml of pure oxygen to the wound site.
16037222|NCT02615366|Drug|Tranexamic Acid|
16037223|NCT02615366|Drug|Placebo|
16037224|NCT02615353|Behavioral|Intensive Lifestyle Intervention|6-months of lifestyle education
16037225|NCT02615353|Other|Usual Care Control|Medical visit and dietary counseling
16037226|NCT02615340|Drug|Melatonin|Study drug will be given at 21:00 - 23:59 daily, starting on the day of enrolment until ICU discharge, death, or up to 14 days, as most critically ill patients are at greatest risk of delirium in the first two weeks of admission. The study medication will be given by mouth (PO or per os) or if needed, via the feeding tube followed by a flush with 20mL water. Doses can be given up to midnight if administration needs to be delayed for procedures or investigations.
16037227|NCT02615340|Drug|Placebo|Study drug will be given at 21:00 - 23:59 daily, starting on the day of enrolment until ICU discharge, death, or up to 14 days, as most critically ill patients are at greatest risk of delirium in the first two weeks of admission. The study medication will be given by mouth (PO or per os) or if needed, via the feeding tube followed by a flush with 20mL water. Doses can be given up to midnight if administration needs to be delayed for procedures or investigations.
16037228|NCT02615327|Dietary Supplement|8 g Polydextrose|8g of Polydextrose
16037229|NCT02615327|Dietary Supplement|12 g Polydextrose|12 g of Polydextrose
16037230|NCT02615327|Dietary Supplement|16 g Polydextrose|16 g of Polydextrose
16037231|NCT02615327|Dietary Supplement|Placebo|0 g of Polydextrose
16037263|NCT02615119|Drug|Isoproterenol|Intravenous infusions of isoproterenol, delivered in a randomized double blinded order, in each participant from each group. Participants will rate the experience of heartbeat and breathing sensations as well as anxiety induced by the infusion.
16037264|NCT02615119|Drug|Normal saline|Intravenous infusions of normal saline, delivered in a randomized double blinded order, in each participant from each group. Participants will rate the experience of heartbeat and breathing sensations as well as anxiety induced by the infusion.
16037232|NCT02615314|Procedure|Particle re-positioning maneuver|Patients with posterior canal BPPV (PC-BPPV) were treated with Epley maneuver. Patients with superior canal (SC-BPPV) were treated with Li or reverse Epley maneuver. Patients with lateral canal (LC) apogeotropic or geotropic nystagmus were treated with Barbeque, Semont's or Gufoni maneuvers. If geotropic or ageotropic type nystagmus is equal intensity on both sides. The involved side was determined according to the patient sense of disturbance or lying down positioning test. If the patient has involvement of both sides according to Dix-Hallpike maneuver. Therapeutic maneuver was applied to the more severe side. All patients were re-evaluated at maximum 7 days.
16037233|NCT02615301|Dietary Supplement|Tailor-made salmon with high levels of vitamin D3 and K1|The aims were to investigate how intake of tailor-made salmon with high levels of vitamin D3 and K1 affected bone biomarkers, nutritional status (vitamin D, omega-3), as well as body composition and bone mineral density.
16037234|NCT02615301|Dietary Supplement|Tailor-made salmon with low levels of vitamin D3 and high K1|The aims were to investigate how intake of tailor-made salmon with low levels of vitamin D3 and high K1 affected bone biomarkers, nutritional status (vitamin D, omega-3), as well as body composition and bone mineral density.
16037235|NCT02615301|Dietary Supplement|Tailor-made salmon with high levels of vitamin D3 and low K1|The aims were to investigate how intake of tailor-made salmon with high levels of vitamin D3 and low K1 affected bone biomarkers, nutritional status (vitamin D, omega-3), as well as body composition and bone mineral density.
16037236|NCT02615301|Dietary Supplement|Supplement with vitamin D and Calcium|The aims were to investigate how supplement with vitamin D and Calcium affected bone biomarkers, nutritional status (vitamin D, omega-3), as well as body composition and bone mineral density.
16037237|NCT02615288|Dietary Supplement|Vitamin D3|
16037238|NCT02615275|Procedure|Bioelectric Impedance Analysis|Undergo BIA with seca mBCA
16037239|NCT02615275|Procedure|Computed Tomography|Undergo CT
16037240|NCT02615275|Procedure|Positron Emission Tomography|Undergo PET
16037241|NCT02615275|Other|Quality-of-Life Assessment|Ancillary studies
16037242|NCT02615275|Other|Questionnaire Administration|Ancillary studies
16037243|NCT02615275|Radiation|Radiation Therapy|Undergo RT
16037244|NCT02615262|Drug|Dexamethasone|
16037245|NCT02615262|Drug|Placebo|0.9% Sodium Chloride
16037246|NCT02615249|Biological|Metal Allergen Epicutaneous Patch|48 hour application of metal allergen patch to diagnose contact dermatitis
16037247|NCT02615236|Device|perineal ultrasound|transvaginal probe will be used to scan the perineum immediately after vaginal delivery in primiparous women
16037248|NCT02615236|Procedure|Clinical diagnosis|diagnosis of OASIS clinically
16037249|NCT02615223|Procedure|cryoablation|Cryoablation therapy
16037250|NCT02615223|Drug|Bicalutamide|bicalutamide
16037251|NCT02615223|Drug|luteinizing-hormone releasing-hormone (LHRH) agonist|luteinizing-hormone releasing-hormone (LHRH) agonist
16037252|NCT02615210|Device|SOC-directed biopsies using the SpyGlass System|The cholangioscopy procedure with the SpyGlass System is performed by a single operator with the SpyScope Access and Delivery Catheter positioned just below the operating channel of the duodenoscope. SpyBite Biopsy Forceps guided by the SpyScope Catheter are introduced and endoscopic-guided biopsy is taken at the level of the stricture. Target lesions will be identified under direct visualization using the SOC system, and 6-8 bites will be performed with the SpyBite forceps. Once SOC-directed biopsies are obtained, the SOC system will be withdrawn into the working channel of the duodenoscope and removed Patient will be contacted monthly to determine if they have undergone any additional procedures and to record potential adverse events.
16037253|NCT02615197|Behavioral|Dialectical Behavior Therapy|Includes all components of standard DBT (individual therapy, group skills training, phone coaching, and therapist consultation team).
16037254|NCT02615197|Behavioral|Dialectical Behavior Therapy Prolonged Exposure protocol|Includes an adapted version of Prolonged Exposure therapy for PTSD.
16037255|NCT02615184|Drug|Dexlansoprazole|Dexlansoprazole capsules
16037256|NCT02615184|Drug|Placebo|Dexlansoprazole placebo-matching capsules
16037257|NCT02615171|Behavioral|Comprehensive Dietary Self-Monitoring; Device: smartphone; Other: physical activity|The intervention includes Facebook-delivered weight loss counseling and the use of MyFitnessPal, a comprehensive diet and exercise self-monitoring app. The intervention will last for 12 weeks. In addition to weight loss counseling in a private Facebook group, participants will be encouraged to use the self-monitoring app to enter everything they eat and do for exercise during the intervention period (12 weeks). Participants will receive a daily calorie goal directly from the app. Participants will receive a Fitbit scale to take their weight weekly and at assessments.
16037258|NCT02615171|Behavioral|Simple Dietary Self-Monitoring; Device: smartphone; Other: physical activity|Arm: Active Comparator: Simple Dietary Self-Monitoring he intervention includes Facebook-delivered weight loss counseling and the use of Slip Buddy, an app created by the investigative team that only requires users to record instances of overeating by hitting a single button and then indicate the overeating trigger and stress and hunger levels. The intervention will last for 12 weeks. In addition to the weight loss counseling, participants will be asked to use the Slip Buddy app during the intervention period (12 weeks). Participants will receive a Fitbit scale to take their weight weekly and at assessments.
16037259|NCT02615158|Behavioral|Maternal Physical Activity and Nutrition|At each session, mothers will identify a dietary goal for the next session (e.g., reduce soda intake). They will learn to track and evaluate their progress, setting new goals or modifying existing ones as necessary. Mothers will be given pedometers and shown how to keep a pedometer tracking chart. As with dietary choice, our objective is to have the mothers identify personal goals and strategies to achieve those goals, so they are more likely to continue to engage in physical activity after the intervention ends.
16037260|NCT02615158|Behavioral|Parenting|Behavior and Development Related to Diet and Physical Activity. The toddler parenting intervention will include modules on toddler behavior and development. We will devote sessions to topics involving parenting toddlers, limit setting, and child development.
16037261|NCT02615158|Behavioral|Child Safety|The intervention will focus on child safety issues, including car seat safety, fire safety, fall prevention, and poison prevention. Participants will set weekly child safety goals.
16037262|NCT02615132|Behavioral|iPad|Using iPad speech therapy apps on patients with post-stroke communication deficits
16037265|NCT02615106|Drug|Endostar|7.5 mg/m2/day, day 1-14
16037267|NCT02615080|Drug|CRD007|
16037270|NCT02615067|Diagnostic Test|Whole-Body Planar and pelvic SPECT/CT scan|A whole-body planar and pelvic SPECT/CT scan will be obtained 3-6 hours after injection of 99mTc-MIP-1404.
16037271|NCT02615054|Device|2D Echocardiogram|All patients will undergo a two-dimensional echocardiogram with speckle tracking strain analysis within the MSK echocardiography laboratory.
16037272|NCT02615054|Device|Cardiopulmonary exercise testing and post-CPET cardiac function|To determine VO2peak, an electronic motorized treadmill test with 12-lead ECG monitoring (Mac ® 5000, GE Healthcare) will be performed by certified exercise physiologists.
16037273|NCT02615041|Drug|Meropenem|1 g in 100 ml of normal saline solution and administered via bolus injection Blood samples (approximately 5 ml)will be obtained by direct venepuncture at the following time: before (time zero) and 10 and 30 min and 1, 1.5, 2, 2.5, 3.5, 4, 4.5, 5, 6, and 8 hh after 3rd dose of meropenem
16037274|NCT02615041|Drug|Meropenem|"1 g in 100 ml of normal saline solution and administered via an infusion pump at a constant flow rate over 3 h every 8 h.
~Blood samples (approximately 5 ml)will be obtained by direct venepuncture at the following time: before (time zero) and 10 and 30 min and
~1, 1.5, 2, 2.5, 3.5, 4, 4.5, 5, 6, and 8 h after the 3rd dose of meropenem."
16037275|NCT02615041|Drug|Meropenem|"2 g in 100 ml of normal saline solution and administered via an infusion pump at a constant flow rate over 3 h every 8 h.
~Blood samples (approximately 5 ml)will be obtained by direct venepuncture at the following time: before (time zero) and 10 and 30 min and 1, 1.5, 2, 2.5, 3.5, 4, 4.5, 5, 6, and 8 h after the 3rd dose of meropenem."
16037276|NCT02615028|Other|Closed eyes double-leg stance|Closed eyes double-leg stance: Body relaxed with both arms naturally placed beside thighs, eyes closed for 40 seconds.
16037277|NCT02615015|Other|Blood draw|
16037278|NCT02615002|Drug|Piromelatine|
16037279|NCT02615002|Drug|Placebo|
16037280|NCT02614989|Procedure|MRI guided focused ultrasound thalamotomy|MRI guided focused ultrasound thalamotomy
16037281|NCT02614976|Device|Padding|"Padding webrill (Covidian) TM 6"
16037282|NCT02614963|Drug|Clostridium Butyricum|Irritable bowel syndrome patients treated with Clostridium Butyricum
16037283|NCT02614963|Drug|placebo|Irritable bowel syndrome patients treated with placebo
16037284|NCT02614950|Other|Treatment interruption|
16037285|NCT02614937|Drug|ranibizumab|0.5 mg IVT ranibizumab
16037286|NCT02614937|Drug|Squalamine Lactate Ophthalmic Solution, 0.2%|Squalamine Lactate Ophthalmic Solution BID
16037287|NCT02614924|Device|Flexible fibreoptic scope|Patient intubated using fibreoptic scope
16037288|NCT02614924|Device|Pentax AWS videolaryngoscope|Patient intubated using Pentax AWS videolaryngoscope
16037289|NCT02614911|Other|Biological sampling|Biological sampling including blood, feces, biopsies...
16037290|NCT02614898|Other|Eculizumab|This study was an observational study. Therefore, the study drug was not provided as part of this study, and the dosing regimen was based solely at the discretion of the treating physician.
16037291|NCT02614885|Device|RFA|Radiofrequency ablation of the cavity walls of a simulated lumpectomy in the excised prophylactic mastectomy tissue.
16037292|NCT02614872|Drug|GLASSIA® and Institution standard of care (SOC)|Alpha-1 Antitrypsin (AAT) [GLASSIA®] add-on pharmacotherapy and Institution standard of care (SOC)
16037293|NCT02614859|Drug|Bicalutamide|Bicalutamide 50 mg daily beginning at cycle 3 to cycle 8
16037294|NCT02614859|Drug|Metformin and Bicalutamide|Metformin 1000mg twice a day Bicalutamide 50 mg daily beginning at cycle 3
16037295|NCT02614846|Drug|Hetrombopag Olamine|
16037296|NCT02614833|Biological|IMP321 (eftilagimod alpha)|In the placebo-controlled, double-blind randomisation stage, paclitaxel + IMP321 at the RPTD will be compared to paclitaxel + placebo
16037297|NCT02614833|Drug|Placebo|In the placebo-controlled, double-blind randomisation stage, paclitaxel + placebo will be compared to paclitaxel + IMP321 at the RPTD
16037298|NCT02614833|Drug|Paclitaxel|Paclitaxel will be given in both treatment arms (classified as Non IMP)
16037299|NCT02614820|Procedure|Remote Ischemic Preconditioning Training Apparatus|
16037300|NCT02614807|Dietary Supplement|Nepro|The intervention is a dietary protein supplement. In the elderly hypertensive patient (assuming body weight of 70 kg) with mild to moderate hyponatremia free water excess is around 2.5 L. One bottle of Nepro/day will generate about 120 mosm to be excreted via urine. Given limited and mostly fixed urinary dilution and concentration between 300 and 800 mosm/L in the elderly and very elderly, one bottle of Nepro a day will result in an extra 400 ml of urine for a net loss of 163 ml of free water. Thus over the period of 2 to 4 weeks the calculated free water excess should be completely eliminated.
16037301|NCT02614794|Drug|tucatinib|300 mg orally twice daily
16037302|NCT02614794|Drug|capecitabine|1000 mg/m2 orally twice daily on Days 1-14 of each 21-day cycle
16037303|NCT02614794|Drug|trastuzumab|8 mg/kg intravenously (IV) on Day 1 of Cycle 1, followed by 6 mg/kg on Day1 of each 21-day cycle. In regions where approved, trastuzumab may be given at 600mg subcutaneously once every 3-weeks at either study initiation or crossing over from previous IV trastuzumab.
16037304|NCT02614794|Drug|placebo|Oral dose twice daily
16037305|NCT02614768|Device|Glucose Sensor|"The investigational intervention is CGM monitoring using four different CGM systems. Three of the four CGM devices which are used will be CGM systems which have received conformité européenne (CE) certification (Dexcom G4 Platinum, Medtronic MiniMed 640G system, Abbott FreeStyle Libre Flash). The SPIDIMAN sensor will be used for the first time in human subjects, does not yet have received CE certification and will be given an identifying label in addition to being labelled for investigative use only."
16037306|NCT02614742|Drug|SFX-01|An intervention releasing sulforaphane.
16037307|NCT02614742|Drug|Placebo|Placebo otherwise identical to Active product
16037308|NCT02614729|Other|Standard Protein-Plant, Even Distribution (SP-PLANT-EVEN)|Diet contains all plant proteins. Meals are evenly distributed throughout the day.
16037309|NCT02614729|Other|Standard Protein-Beef, Even Distribution (SP-BEEF-EVEN)|Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
16037310|NCT02614729|Other|High Protein-Beef, Even Distribution (HP-BEEF-EVEN)|Diet contains combination of beef and plant proteins. Meals are evenly distributed throughout the day.
16037311|NCT02614729|Other|High Protein-Beef, Uneven Distribution (HP-BEEF-UNEVEN)|Diet contains combination of beef and plant proteins. Meals are unevenly distributed throughout the day.
16037315|NCT02614703|Other|Standard random esophageal biopsies|Random esophageal biopsies performed as per protocol
16037316|NCT02614690|Procedure|No Split Cast of forearm fractures|"Enroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to No Split Cast will have a cast that is not split, this is known as closed cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months."
16037317|NCT02614690|Procedure|Univalve Split Cast of forearm fractures|"Enroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to Univalve Cast will have a cast that is split on only one side of the cast, this is known as univalve cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months."
16037318|NCT02614690|Procedure|Bivalve Split Cast of forearm fractures|"Enroll 20 patients per arm: patients who present for long arm casts after closed reduction of forearm fractures will be randomized to one of 3 arms. Patients randomized to Bivalve Cast will have a cast that is split on both sides of the cast, this is known as bivalve cast. The cast will be applied according to our Standard of Care casting. Patients will be then undergo follow-up for clinical and radiographic examinations based on the routine fracture management protocol for approximately 3 months."
16037319|NCT02614664|Device|NIRS|Cerebral oxygenation monitor which is standard of care for this surgery.
16037320|NCT02614651|Procedure|Find visual comfort threshold related to light intensity|"In this testing session, the patient's visual comfort threshold related to light intensity will be determined. Test sessions are kept under 45 minutes.
~The subject is sitting in front of a keyboard and a computer screen. He/she is invited to recognize letters successively displayed in the center of the screen, this center is marked with a black cross. Each letter appearance is preceded by a beep. The subject must click on the space bar on the keyboard as soon as he/she recognizes the letter, then gives his/her answer orally."
16037321|NCT02614651|Procedure|Find the size of the visual field|For these tests, the subject is seated at a table, 1.5m from a wall. It features a computer keyboard. It projects an image on the wall, using to a video projector. An image moving towards a target (along 16 different trajectories) is used to evaluate the size of the visual field.
16037322|NCT02614651|Procedure|Effectiveness of brightness control|"During this testing session, the investigators seek to evaluate the effectiveness of the algorithms used to control the brightness.
~The subject is in a room with four different computers. The subject is asked to identify the objects displayed on different computer monitors in the room: he/she must press a key on the keyboard when he/she detects an object and state aloud the nature of the object."
16037323|NCT02614651|Procedure|Performance of color correction|"During this session, the investigators try to assess the performance for the color vision correction (saturation and hue).
~The subject, while wearing the virtual reality glasses + camera performs a test (twice) that requires matching colored dots (i.e. a Farnsworth test) under controlled light conditions."
16037324|NCT02614651|Device|Vuzix Wrap 1200DX virtural reality glasses|The other interventions are performed with the use of virtual reality glasses, specifically the Vuzix Wrap 1200DX. In case of technical difficulties, the latter can be swapped with the Oculus Rift model or another model. The associated webcameras are from Logitech, and the exact model used can vary and does not carry any importance for this research.
16037325|NCT02614638|Other|One month of department-wide observation|A pharmacy technician will be present full time in the care unit from Monday to Friday between 8:30 and 17h for 1 month for observational purposes only. During this phase, the pharmacy technician observes the current practices of preparation and administration of medication by nurses. He / she will collect medication errors and other observational data.
16037326|NCT02614638|Other|Pharm Tech participates in department|Following a 1 month wash-out period, a pharmacy technician will again be present full time (in practice, two technicians will relay each other) in the care unit from Monday to Friday between 8:30 and 17h for 1 month. He/she will actively take part in drug care activities in the department: management of product pathways, verification of injectable preparation, advice, etc. Medication errors and other observational data will be collected.
16037327|NCT02614612|Drug|Itacitinib (200 mg)|
16037328|NCT02614612|Drug|Itacitinib (300 mg)|
16037329|NCT02614612|Drug|prednisone or methylprednisolone (corticosteroids)|All subjects will receive prednisone 2.5 mg/kg per day PO (or methylprednisolone 2 mg/kg IV daily) on Days 1 through 5. Subjects will be tapered as tolerated beginning on Day 6 to no less than 0.25 mg/kg per day PO (or methylprednisolone 0.2 mg/kg per day) by Day 28. After Day 28, corticosteroids should be tapered according to institutional guidelines to attain ≤ prednisone 0.2 mg/kg per day (or ≤ methylprednisolone 0.16 mg/kg per day) by Day 56.
16037330|NCT02614599|Drug|BP22042013|This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.
16037331|NCT02614599|Dietary Supplement|Low carbohydrate diet|the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements
16037332|NCT02614586|Drug|TAK-058|TAK-058 oral solution.
16037333|NCT02614586|Drug|Ondansetron|Ondansetron capsule.
16037334|NCT02614586|Drug|TAK-058 Placebo|TAK-058 placebo-matching, solution.
16037335|NCT02614586|Drug|Ondansetron Placebo|Ondansetron placebo-matching, capsule.
16037336|NCT02614573|Device|CoagucheckXSR Capillary INR measures|"We will be using the CoagucheckXSR device for capillary INR measures performed by nurses every 7 days during the 6 months of the study, plus after related intercurrent events.
~If capillary INR is <2 or >3 (with a tolerance of 1.9 to 3.1 given the margin of measurement inaccuracy of the coagulometer), then a classic venous measure is performed. If both tests agree, adaptation of treatment as indicated. If slightly discordant results, then the INR values are considered discordant and the decision to adjust the treatment dose and the next monitoring date for venous INR is made based on the value of the venous INR, according to the predefined protocol. If clinically significant discordance (> 0.3), a venous INR is reperformed within 24 hours and if the discrepancy persists, dose adjustment is made according to the venous INR and the predefined protocol.
~If capillary INR is > 4, then verification by venous measure and refer to general practitioner."
16039436|NCT02600117|Drug|Tenofovir disoproxil fumarate|300 mg, oral, once a day
16037337|NCT02614560|Drug|Fludarabine|30 mg/m2/day intravenously, 5 to 2 days before the transplant (total dose of 120 mg/m2)
16037338|NCT02614560|Drug|Melphalan|Melphalan 140 mg/m2 intravenously, 2 days before the transplant
16037339|NCT02614560|Drug|vadastuximab talirine|Pre-allo (before stem cell transplant) given 14 days before the stem cell transplant
16037340|NCT02614560|Drug|vadastuximab talirine|Post-allo (after stem cell transplant) given on Day 1 of each cycle
16037341|NCT02614547|Drug|SAGE-547|Administered as intravenous infusion.
16037342|NCT02614547|Drug|Placebo|Administered as intravenous infusion.
16037343|NCT02614534|Drug|MITOMYCIN-C 40 mg|Proactive cytoreductive surgery: Tumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women) plus HIPEC with Mytomicin C for 60 minutes.
16037344|NCT02614534|Procedure|Proactive cytoreductive surgery|Proactive cytoreductive surgery: Tumoral cytoreductive surgery + apendicectomy + total omentectomy + round hepatic ligament + oophorectomy (postmenopausian women)
16037345|NCT02614521|Other|pulmonary veins ablation's successful outcome|Assessment of predictive factors in patients with successful outcome of pulmonary veins ablations and suffer from paroxysmal atrial fibrillation.
16037346|NCT02614508|Drug|Buparlisib|Given PO
16037347|NCT02614508|Drug|Ibrutinib|Given PO
16037348|NCT02614508|Biological|Ofatumumab|Given IV
16037349|NCT02614495|Drug|Surufatinib|Patients receive oral Sulfatinib at a dose of 300mg/d within 1 hour after breakfast (once-daily dosing continuously, every 28-day treatment cycle)
16037350|NCT02614482|Drug|Fesoterodine|Administer medication to patients with overactive bladder
16037351|NCT02614469|Drug|Inosine|Inosine, 1000 mg
16037352|NCT02614456|Drug|interferon-gamma and nivolumab|
16037353|NCT02614443|Other|Space from Depression|Delivered through the online SilverCloud platform, the program for the treatment of depression employs several innovative engagement strategies for improving the user experience. These are divided into several categories: personal, interactive, supportive, and social.
16037354|NCT02614443|Other|Space from Anxiety|Delivered through the online SilverCloud platform, the program for the treatment of anxiety employs several innovative engagement strategies for improving the user experience. These are divided into several categories: personal, interactive, supportive, and social.
16037355|NCT02614443|Other|Space from Stress|Delivered through the online SilverCloud platform, the program for the treatment of stress employs several innovative engagement strategies for improving the user experience. These are divided into several categories: personal, interactive, supportive, and social.
16037356|NCT02614430|Other|Vocational training|The intervention consists of a physical training program, individual motivational talks and guidance on labor market-oriented topics. Each program is customised to the patient's physical resources and conditions where. The framework for the intervention of physical activity 1 hours 3 times weekly with concurrent motivational talks for an overall maximum duration of 9 weeks. Based on an assessment of the patient is instructed about pain management, ergonomics, conflict management, diet, lifestyle, behavior modification, stress symptoms and preventive home training.
16037357|NCT02614417|Other|Polysomnography|One night polysomnography performed using standard techniques and scored in accordance with American Academy of Sleep Medicine standards. Polysomnography monitors sleep by electroencephalography (F4-A1, C4-M1, O2-M1 F3-M2, C3-M2, O1-A2), electro-myography (submental and tibialis anterior muscles), electro-oculography, nasal flow, respiratory effort, pulse oximetry and transcutaneous carbon dioxide partial pressure.
16037358|NCT02614404|Drug|Imatinib combination therapy|Imatinib plus dihydroartemisinin plus piperaquine
16037359|NCT02614404|Drug|Dihydroartemisinin-piperaquine|Standard of care
16037360|NCT02614391|Other|Active distraction using a tablet|Playing a videogame using a computer tablet
16037361|NCT02614391|Other|Passive distraction|A nurses singing a song, reading a book, blowing bubbles and playing a puppet show
16037362|NCT02614378|Procedure|air insufflation|modulated air insufflation of the ear canal
16037363|NCT02614378|Procedure|placebo|no air will be introduced in the ear canal
16037364|NCT02614365|Behavioral|Aerobic exercise|Cardiovascular fitness
16037365|NCT02614365|Behavioral|Stretch exercise|Muscle stretch
16037366|NCT02614352|Drug|Atorvastatin + Candesartan|
16037367|NCT02614352|Drug|AG1502|
16037368|NCT02614339|Drug|metformin|The patients of this group are treated according to NCCN guideline for stage II high-risk/ III colorectal cancer and receive an additional prescription metformin. Metformin will be prescribed 1g/day (500mg, 2 table/day, or 1000mg, 1 table/day). After adjustment period for 1month, patients who do not have side effects will be taken metformin for additional 47 months (total 48months including the adjustment period).
16037369|NCT02614339|Drug|control|The patients of this group are treated according to NCCN guideline for stage II high-risk/ III colorectal cancer.
16037370|NCT02614326|Behavioral|Autobiographical Memory Flexibility (MemFlex) training|As in experimental arm description
16037371|NCT02614326|Behavioral|Psychoeducation|As in experimental arm description
16037372|NCT02614313|Procedure|Open breath test with fructose|Open randomised fructose 35g during breath test
16037373|NCT02614313|Procedure|Breath test with sweet placebo (Assugrin)|Double-blind randomised breath-testing with sweet placebo (Assugrin)
16037374|NCT02614313|Procedure|Breath test with neutral placebo (still water)|Double-blind randomised breath-testing with neutral placebo
16037375|NCT02614313|Procedure|Blinded breath test with fructose|Double-blind randomised fructose 35g during breath test
16037376|NCT02614300|Other|Pulmonary Rehabilitation and Chest Physiotherapy|The patient will come 3 times per week during 12 weeks Each session 1h15min
16037377|NCT02614300|Other|Pulmonary Rehabilitation|The patient will come 3 times per week during 12 weeks Each session 45min
16037378|NCT02614300|Other|Chest Physiotherapy|The patient will come 3 times per week during 12 weeks Each session 30min
16037379|NCT02614287|Drug|Galcanezumab|Administered SC
16037380|NCT02614274|Dietary Supplement|Nutraceutical joint health formulation|A Proprietary Blend
16037381|NCT02614261|Drug|Galcanezumab|Administered SC
16037382|NCT02614261|Drug|Placebo|Administered SC
16037383|NCT02614248|Other|Organic, Unrefined Coconut Oil|
16037384|NCT02614248|Other|Medline Remedy Phytoplex Z-Guard Skin Protectant|
16037385|NCT02614235|Device|Pocket-ECG III system|Continuous cardiac telemetry until diagnosis or a maximum of two months
16037386|NCT02614222|Device|Peripheral Nerve Blocks with CAIG|The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure.
16037387|NCT02614209|Device|In Vitro diagnostic tests|Prospective blood collection
16037388|NCT02614196|Drug|Galcanezumab|Administered SC
16037389|NCT02614196|Drug|Placebo|Administered SC
16037390|NCT02614183|Drug|Galcanezumab|Administered SC
16037391|NCT02614183|Drug|Placebo|Administered SC
16037392|NCT02614170|Other|Prospective Blood Draw|This is prospective collection blood and urine study. This is not a treatment trial or device trial.
16037393|NCT02614157|Procedure|LLND|advanced rectal cancer patients whose lymph nodes are suspiciously enlarged after neoadjuvant chemoradiation will undergo lateral lymph node dissection (LLND) and total mesorectal excision (TME)
16037394|NCT02614157|Device|labeled line|
16037395|NCT02614131|Drug|LY2599666|Administered SC
16037396|NCT02614131|Drug|Solanezumab|Administered IV
16037397|NCT02614131|Drug|Placebo SC|Administered SC
16037398|NCT02614131|Drug|Placebo IV|Administered IV
16037399|NCT02614118|Drug|Ketorolac tromethamine|10 mg oral Ketorolac tromethamine 45 minutes before root canal treatment
16037400|NCT02614118|Drug|Acetaminophen|1000 mg oral Acetaminophen along with10 mg oral Ketorolac tromethamine 45 minutes before root canal treatment.
16037401|NCT02614118|Drug|Placebo|placebo 45 minutes before root canal treatment
16037402|NCT02614105|Procedure|Pelvic floor muscle training|16 weeks of group-based exercise
16037403|NCT02614105|Procedure|Cough-suppression therapy|Group and individual sessions of respiratory physiotherapy with focus on techniques to suppress cough
16037404|NCT02614105|Other|Control|Brief information only
16037405|NCT02614092|Behavioral|Water-based Activity + Cognitive Training|This is an 8 month long two phase intervention. The first phase consists of 6 months of thrice weekly pool based physical activity occurring at the Palo Alto VA Health Care System. After completion of the 6 month long water based physical activity, participants transition to a ten session cognitive training program at the Palo Alto VA. The cognitive training classes are approximately two hours in length and will be spread over ten sessions across 4 weeks.
16037406|NCT02614079|Device|DSSEP|Collision testing after the placement of SCS leads
16037407|NCT02614066|Biological|brexucabtagene autoleucel (KTE-X19)|
16037408|NCT02614066|Drug|Cyclophosphamide|Administered intravenously
16037409|NCT02614066|Drug|Fludarabine|Administered intravenously
16037410|NCT02614053|Device|Masimo Radical-7™ Pulse CO-Oximeter|a device collecting data regarding PVI, PI & spHB
16037411|NCT02614040|Other|0.9% Saline|0.9% Saline will be used whenever an isotonic crystalloid is ordered
16037412|NCT02614040|Other|Physiologically-balanced isotonic crystalloid|Lactated Ringers or Plasma-Lyte© A will be used whenever an isotonic crystalloid is ordered
16037413|NCT02614027|Other|Evaluation of metabolic syndrome|Evaluation and analytical determinations of the different components of the syndrome
16037414|NCT02614027|Other|Evaluation of changes in fat by DXA while on current therapy|Comparison of changes in fat (visceral and subcutaneous) by dual X-ray absorptiometry since therapy initiation
16037415|NCT02614014|Behavioral|Cognitive-behavior interventional program|
16037416|NCT02614001|Device|Threshold® IMT HS730, RESPIRONICS Inc, Cedar Grove, NJ, USA|Patient will be trained daily, total 30 minutes or 15 minutes twice per day, at least 5 times a week, for 10 weeks
16037417|NCT02614001|Other|post-stroke rehabilitation program|
16037418|NCT02613988|Device|3 Tesla magnetic resonance imaging|High resolution structural imaging (contrast-enhanced T1-weighted image, T2-weighted image, Fluid-attenuated inversion recovery)
16037419|NCT02613988|Device|Chemical exchange saturation transfer MRI|Amide proton transfer-weighted image
16037420|NCT02613988|Device|Diffusion weighted MRI|diffusion-weighted image with b value 0, 1000, and 3000
16037421|NCT02613988|Device|Dynamic susceptibility contrast MRI|dual echo EPI sequence
16037422|NCT02613975|Device|positonal device|positional device detects prone positional and will vibrate to cause patient to lie laterally
16037423|NCT02613962|Procedure|biopsy or surgical resection of tumor and blood sampling|
16037424|NCT02613949|Device|RINCE|The NeuroPoint device is used to deliver repeat applications of RINCE therapy
16037425|NCT02613936|Device|Anodal tDCS|Anodal tDCS lowers neuronal membrane potentials, leading to increased probability of depolarization from incoming stimuli.
16037426|NCT02613936|Behavioral|Cognitive training|Cognitive training involves solving executive function tasks on a computer.
16037427|NCT02613923|Behavioral|GO! To Sleep|Controlled sleep intervention. Provide online education and reminder emails on improving sleep behavior
16037428|NCT02613923|Behavioral|Sleep information|Participants will receive weekly emails on the health benefits of sleep for 6 weeks
16037429|NCT02613923|Procedure|Blood Draw|blood sample measured for stress and sleep markers
16037430|NCT02613923|Other|Pittsburgh Sleep Quality Index (PSQI)|Assessment of sleep quality. This is a continuous measure from 0 (best) to 21 (worst). Sleep duration will be obtained directly from responses.
16037431|NCT02613923|Other|Insomnia Severity Index (ISI)|
16037432|NCT02613923|Other|SF-12 quality of life survey|
16037433|NCT02613910|Drug|Ofatumumab|Ofatumumab (human monoclonal antibody) will be provided as a liquid concentrate in a prefilled glass syringe with staked needle, stopper, and plunger containing 0.4 millilitre (mL) (20 mg) drug product of 50 mg/mL concentration
16037434|NCT02613910|Drug|Acetaminophen/paracetamol|Acetaminophen/paracetamol will be supplied by study centre as 1 gram tablet, caplet, capsule or liquid for oral administration
16037435|NCT02613910|Drug|Antihistamine (cetirizine or equivalent)|Antihistamine (cetirizine or equivalent) will be supplied by study center as 10 mg tablet, caplet, capsule or liquid for oral administration
16037436|NCT02613910|Drug|Prednisone/Prednisolone|Prednisone/Prednisolone will be supplied from the dose range 2.5, 5, 7.5, 10, 12.5, 15, 17.5, 20, 25, 30, 40, 50, 60, 80, 100, 120, 140, 160, 180, 200, 220 and 240 mg for oral administration
16037437|NCT02613897|Drug|Saxagliptin|Saxagliptin (Onglyza™) is approved by the US FDA as an adjunct to diet and exercise to improve glycemic control in adults with T2DM. The 5 mg dose will be used for this study as it is the dose that is routinely used in the clinic. In addition, this dose is used in the pivotal studies in the saxagliptin/dapagliflozin clinical program.
16037438|NCT02613897|Drug|Dapagliflozin|Dapagliflozin (Farxiga) is approved by the FDA as an adjunct to diet and exercise to improve glycemic control in adults with T2DM. Dapagliflozin (Farxiga) is also approved in the EU as an adjunct to diet and exercise to improve glycemic control in patients with T2DM for whom metformin use is considered inappropriate due to intolerance, and in combination with other glucose-lowering medicinal products when these, in combination with diet and exercise do not provide adequate glycemic control. The 10 mg dose was chosen for this study because it has been extensively studied in Phase 3 trials and has demonstrated a favorable benefit-risk profile. In addition, this dose is the most commonly used dose in most countries.
16037439|NCT02613897|Drug|Placebo|Placebo
16037440|NCT02613884|Drug|Treatment|
16037441|NCT02613871|Drug|LDV/SOF|90/400 mg FDC tablet administered orally once daily
16037442|NCT02613845|Other|no intervention|
16037443|NCT02613832|Other|EPAP|The EPAP will be applied with a Spring Load Valve Resistor (Vital Signs, Totowa, NJ, USA), adjusted with a pressure of 10 cmH2O. The Spring Load Valve Resistor will be connected to the expiratory branch of the T-tube. Duration of intervention: 5 minutes.
16037444|NCT02613832|Other|Breath Stacking|The BS will be performed by a T-tube with a one-way inspiratory valve and the expiratory branch occluded. The expiratory occlusion is maintain until observed the presence of a plateau in the impedance plethysmogram by EIT, which corresponds to the absence of inspired air displacement or when a maximum time of 40 seconds was attained. Durantion of intervention:Three BS interventions will be performed at one minute intervals between them.
16037445|NCT02613819|Radiation|SABR|"Renal cell carcinoma (RCC) is conventionally considered radioresistant to fully fractionated EBRT. In an effort to overcome the perceived radioresistance of RCC, severely hypofractionated External beam radiation therapy (EBRT) in the form of stereotactic radiotherapy will be used in the management of renal cell carcinoma with radiotherapy."
16037446|NCT02613806|Drug|Dexmeditomidine|Dexmeditomidine 0.2 ug/kg·h will be administered to participants by intravenous infusion at the beginning of the surgery,and continued till end of surgery.
16037447|NCT02613806|Drug|normal saline|Isovolumetric normal saline will be administered to participants by intravenous infusion at the beginning of the surgery,and continued till end of surgery.
16037448|NCT02613780|Procedure|Crosslinking|corneal collagen crosslinking with riboflavin
16037449|NCT02613780|Procedure|Photorefractive keratectomy|
16037450|NCT02613780|Device|iDesign® Advanced WaveScan Studio|Used to map wavefront aberration in planning photorefractive keratectomy
16037451|NCT02613767|Other|Protein meal|Ingestion of protein
16037452|NCT02613767|Other|L-[ring 13C6]Phenylalanine infusion|experimental method for determining protein synthesis rates
16037453|NCT02613754|Behavioral|Contingency Management|See arm description.
16037454|NCT02613754|Behavioral|Treatment as Usual|See arm description
16037455|NCT02613741|Other|Lifestyle-based physical activity|Obese subjects will undergo a randomized physical activity-based weight reduction program (12 weeks). The lifestyle intervention will be determined based on an initial evaluation of each subjects' energy expenditure (by indirect calorimetry). Caloric intake will be set to elicit the loss of 1 to 1.5 lbs/week. The subjects and the family will meet with a dietitian once/week for 12 weeks. The intervention group will undergo an aerobic exercise program 3 times/week. The duration of exercise will be progressively increased from 20 to 45 minutes/session. The subjects will keep daily record of exercise activity and food intake. Interventions will be monitored during the subjects' weekly visit with the research group and they will be given counseling to stick to the intervention program.
16037456|NCT02613728|Behavioral|Accelerated Recovery Plan|
16037457|NCT02613728|Behavioral|Early Discharge|
16037458|NCT02613728|Other|Telemedicine|
16037459|NCT02613728|Behavioral|Standard Enhanced Care|
16037460|NCT02613715|Dietary Supplement|Blackberry juice with 12% ethanol|
16037461|NCT02613715|Dietary Supplement|Blackberry juice|
16037462|NCT02613702|Procedure|Free Gingival Graft|Surgical technique (autologous graft): Free gingival graft technique, harvested from palate.
16037463|NCT02613702|Procedure|Original Free Gingival Graft technique|Surgical technique (autologous graft): Original technique of free gingival graft, positioned at the inferior incisors area at the donor area
16037464|NCT02613702|Procedure|Modified Free Gingival Graft technique|Surgical technique (autologous graft): Free gingival graft. positioned at the inferior incisors area and covered by a flap at the donor area
16037465|NCT02613689|Behavioral|Scheduled Gradual Reduction (SGR)|Participants in this group will group will receive the Scheduled Gradual Reduction (SGR) smokeless tobacco cessation reduction intervention via text message over a period of four weeks. Participants will initially report their smokeless tobacco use according to their usual habit, and over the course of the intervention be directed via text message precise times to start and stop each instance of smokeless tobacco use, gradually reducing the occurrences of use. In addition, this group will also receive the support messages that are sent to the control group.
16037466|NCT02613689|Behavioral|Text Messages|Participants in this group will receive text messages about smokeless tobacco cessation in the form of counseling messages at various times throughout the day over a period of four weeks.
16037467|NCT02613676|Device|Transcutaneous bilirubin screening|Transcutaneous bilirubin screening before hospital discharge and assessment of risk category according to the Bhutani nomogram
16037468|NCT02613676|Other|Standard care (Visual inspection)|Participants in this group will be assessed for jaundice by visual inspection. Blood draw for TsB will be drawn only if the participant is visibly jaundiced.
16037469|NCT02613663|Procedure|Immediate implants with nanobone graft|Extraction of unrestorable tooth replaced with immediate implant and use nanobone graft to fill the gap.
16037470|NCT02613663|Procedure|immediate implants with autogenous bone graft|Extraction of unrestorable tooth replaced with immediate implant and use autogenous bone graft to fill the gap.
16037511|NCT02613351|Device|scooting|three-wheeled scooter (Monark 662, Monark Exercise AB Sweden) comprised of a single front wheel that provides steering and two rear wheels that create a wide base of support.
16037471|NCT02613650|Drug|MEK162 and mFOLFIRI|"MEK162 in combination with mFOLFIRI in a 14 day cycle
~MEK162 will be given single agent 6 day lead in and then will be given in combination with mFOLFIRI
~mFOLFIRI Administered Day 1 of each cycle Irinotecan 180mg/m2 iv over 90 minutes on day 1 5-fluoruracil 1200mg/m2 continuous infusion for 48 hours (2400mg/m2 in 48 hours)
~Followed by MEK162 - Taken twice daily orally on Days 1-12 of each cycle
~Level -1: mFOLFIRI at 80% + MEK162 30 mg twice daily 1 week on and 1 week off Level 1: mFOLFIRI + MEK162 30 mg twice daily Level 2: mFOLFIRI + MEK162 45 mg twice daily"
16037472|NCT02613637|Other|Registry|
16037473|NCT02613598|Drug|Bortezomib|
16037474|NCT02613598|Drug|Ruxolitinib|
16037475|NCT02613585|Other|Permethrin Impregnated Clothing|Uniforms and work clothing treated with permethrin according to proprietary process used by Insect Shield, Inc.
16037476|NCT02613572|Drug|alpha lipoic acid|
16037477|NCT02613572|Drug|Placebo|
16037478|NCT02613559|Biological|TK001|Intravitreal Injection
16037479|NCT02613546|Behavioral|Cognitive behavioral therapy (CBT)|"The study group will undergo 10 sessions of guidelines and cognitive behavioral therapy (CBT) about an hour long, once a week. Of these:
~evaluation session;
~sessions of psychoeducation about the CBT model
~5 sessions of cognitive restructuring 2 sessions of preventing relapse"
16037480|NCT02613546|Behavioral|Control therapy|The control group will be subjected to 10 weekly sessions (1 time per week) approximately one hour guidelines.
16037481|NCT02613533|Other|Intra-ocular pressure measurement (IOP)|Subjects will be given 10ml/kg of water over 15 min prior to laser peripheral iridotomy (LPI) surgery and Intra-ocular pressure (IOP) is tested every 15 min before and after surgical procedure
16037482|NCT02613520|Biological|PfSPZ Vaccine|Metabolically active, non-replicating, radiation attenuated, aseptic, purified, cryopreserved NF54 P. falciparum (Pf) sporozoites (PfSPZ Vaccine)
16037483|NCT02613520|Other|Normal Saline|0.9% Sodium chloride
16037484|NCT02613520|Biological|PfSPZ Challenge (for CHMI)|live, infectious, aseptic, purified, cryopreserved NF54 P. falciparum (Pf) sporozoites (PfSPZ Challenge) Controlled human malaria infection (CHMI) by direct venous inoculation of 3,200 PfSPZ Challenge
16037485|NCT02613507|Drug|Nivolumab|
16037486|NCT02613507|Drug|Docetaxel|
16037487|NCT02613494|Drug|Hyoscine|300 micrograms twice daily, increasing to 300 micrograms three times daily
16037488|NCT02613494|Drug|Glycopyrrolate|1 milligram twice daily, increasing to 1 milligram three times daily
16037489|NCT02613494|Other|Placebo|Placebo twice daily, increasing to placebo three times daily
16037490|NCT02613481|Drug|Poly-L-Lactic Acid (Sculptra) injection|1 vial of of poly-l-lactic acid (Sculptra) reconstituted in the usual sterile fashion with 7cc of sterile water and 2cc of Lidocaine without epinephrine. The contents of the vial will be injected as deemed appropriate by the certified injector and agreed upon by the study subject.
16037491|NCT02613468|Other|collection of periodontal records|"Clinic attachment level
~Probing depth
~Gingival index
~Plaque index
~Bleeding on probing were performed in all groups. These measurements were performed at the end of each trimester."
16037492|NCT02613468|Other|pregnancy parameters|Parameters such as number of pregnancies, previous low birth weight, prenatal care, genital tract infection, use of antibiotics, smoking, tooth brushing habit and birth weight were evaluated.
16037493|NCT02613468|Other|Initial Periodontal Therapy|Initial Periodontal Therapy is completed ( Supragingival and subgingival calculus elimination, root planning, polishing etc.) This treatment is considered to be the safest time for pregnant mothers was performed in 2 trimester.
16037494|NCT02613455|Procedure|extracorporeal shock wave therapy|Following clearance, patients will be booked for ESWT in the operating room either WRNMMC or Kimbrough Ambulatory Care Center (KACC), depending on availability. Under conscious sedation, patients will receive 2000 shocks at 18-24kV, which is the standard dose utilized by our clinic in treatment of this condition. The range is necessary to account for differing size of the soft tissue envelope depending on patient habitus. The final dose utilized will be at the surgeon's discretion.
16037495|NCT02613455|Drug|Kenalog (triamcinolone)|patients will receive an intratendinous injection in the common tendon origin of the extensor/supinators at the lateral epicondyle by an attending orthopaedic hand surgeon. The injection will contain 1cc of Kenalog-40 (triamcinolone 40mg) + 2cc lidocaine 1% (lidocaine HCl 20mg). This is the standard dose for lateral epicondylitis used routinely in the WRNMMC orthopaedic clinic.
16037496|NCT02613455|Drug|lidocaine 1% (lidocaine HCl 20mg)|patients will receive an intratendinous injection in the common tendon origin of the extensor/supinators at the lateral epicondyle by an attending orthopaedic hand surgeon. The injection will contain 1cc of Kenalog-40 (triamcinolone 40mg) + 2cc lidocaine 1% (lidocaine HCl 20mg). This is the standard dose for lateral epicondylitis used routinely in the WRNMMC orthopaedic clinic.
16037497|NCT02613429|Behavioral|identification of the airway by from the cranial end|The airway is identified with inspection and imaging technique (ultrasound) by placing the ultrasound transducer over the thyroid cartilage and from there moving distally
16037498|NCT02613429|Behavioral|identification of the airway from the distal end|The airway is identified with inspection and imaging technique (ultrasound) by placing the ultrasound transducer over the distal trachea and moving cranially
16037499|NCT02613416|Drug|Denosumab|monthly subcutaneous injections
16037500|NCT02613403|Drug|MK-3682B|Two MK- 3682B 1,136 mg FDC tablets each containing 50 mg MK-5172 (GZR), 225 mg MK-3682 (UPR, formerly IDX21437), and 30 mg MK-8408 (RZR) taken once daily by mouth.
16037501|NCT02613403|Drug|Ribavirin|Ribavirin 200 mg capsules, taken twice daily by mouth as part of a weight-based dosing regimen. Depending on participant body weight, total daily dose of Ribavirin may be 800, 1000, 1200 or 1400 mg per day.
16037502|NCT02613390|Procedure|Magnetic Resonance Imaging (MRI)|MRI images of the spine taken of anesthetized participant in the operative prone position.
16037503|NCT02613390|Behavioral|Questionnaires|Pain and symptom questionnaires completed at baseline and at follow up.
16037504|NCT02613377|Other|Blood transfusion|
16037505|NCT02613364|Behavioral|Behavioral Intervention|Undergo yoga intervention
16037506|NCT02613364|Other|Cognitive Intervention|Undergo CBT-I intervention
16037507|NCT02613364|Other|Educational Intervention|Receive health education
16037508|NCT02613364|Other|Laboratory Biomarker Analysis|Correlative studies
16037509|NCT02613364|Device|Monitoring Device|Correlative studies
16037510|NCT02613364|Other|Quality-of-Life Assessment|Ancillary studies
16037512|NCT02613338|Device|DePuy Attune posterior stabilizing fixed bearing knee system|Individuals implanted with the DePuy Attune posterior stabilizing fixed bearing knee system at least three months post-operative.
16037513|NCT02613325|Device|Functional photoacoustic microscopy|-Hybrid imaging technique that detects absorbed diffusive protons ultrasonically through the photoacoustic effect.
16037514|NCT02613325|Procedure|Standard of care surgical excision|
16037515|NCT02613325|Device|Single cell photoacoustic microscopy|
16037516|NCT02613286|Procedure|Extrafascial Hysterectomy|Hysterectomy plus Pelvic Lymph-Node Dissection
16037517|NCT02613286|Procedure|Modified radical hysterectomy|Hysterectomy plus Pelvic Lymph-Node Dissection
16037518|NCT02613273|Behavioral|Experimental: Arm 1 (Aerobic Exercise)|This periodized program consists of 3 aerobic exercise sessions per week comprised of two high-intensity interval training workouts and 1 continuous vigorous intensity workout.
16037519|NCT02613273|Behavioral|Experimental: Arm 2 (Resist. Exercise)|This periodized program consisting of 3 resistance exercise sessions per week comprised of high load/low volume, light load/high volume, and moderate load/moderate volume.
16037520|NCT02613260|Behavioral|FIT Outreach|This arm will consist of priming patients with a postcard and a possibly a phone call two weeks prior to them being mailed a FIT kit. The FIT kits will be mailed to the patients with a letter from their clinic's care team informing them why they should complete the FIT and wordless instructions to help them complete the FIT. Two weeks after the FIT kit is mailed the patients that have not returned the kit will receive up to two reminder calls. During the phone calls the outreach workers will use health coaching techniques to encourage patients to complete the FIT. All written materials have been translated into English and Chinese and during phone calls patients will be spoken to in the language that they are most comfortable using.
16037521|NCT02613247|Device|Hylan G-F 20|Intra-articular injection of 6 mL Hylan G-F 20
16037522|NCT02613234|Device|cathode tDCS|"At the first randomized controlled stage, the experimental group will undergo five daily sessions of active brain-wave intervention by cathode tDCS (20min, 1mA) targeting the epileptogenic focus, which is confirmed by 128-channel EEG and BESA dipole localization method.
~At the second open-label extension stage, all the patients will undergo five daily sessions of active intervention (20min, 1mA)."
16037523|NCT02613234|Device|Sham cathode tDCS|"At the first randomized controlled stage, the control group will undergo five daily sessions of sham brain-wave intervention by cathode tDCS (20min, 1mA, the stimulator will be turned off after 5s) targeting the epileptogenic focus, which is confirmed by 128-channel EEG and BESA dipole localization method.
~At the second open-label extension stage, all the patients will undergo five daily sessions of active intervention (20min, 1mA)."
16037524|NCT02613221|Drug|Panitumumab + TAS-102|panitumumab + TAS-102 combination therapy
16037525|NCT02613208|Drug|Bevacizumab|Bevacizumab will be administered as per local clinical practice and local labeling.
16037526|NCT02613208|Drug|Paclitaxel|Paclitaxel will be administered as per local clinical practice and local labeling.
16037527|NCT02613195|Drug|Hydrogen-Rich Celsior Solution|Before the procedure, add hydrogen gas into Celsior solution. After harvesting the liver/kidney grafts, lavage and cold store the grafts with Hydrogen-Rich Celsior Solution.
16037528|NCT02613182|Drug|NEOD001|NEOD001
16037529|NCT02613169|Drug|Isoniazid|HIV-exposed uninfected infants will be randomized to receive either INH or no INH daily for 12 months for the prevention of Mycobacterium tuberculosis (MTB) infection.
16037530|NCT02613156|Procedure|laparoscopic resection|The surgical instruments used for the laparoscopic group included conventional laparoscopic instruments (three 5 mm trocars, two 10 mm trocars, and two damage-free laparoscopic clamps), the STORZ high-resolution laparoscopic operating system (Germany), the GEN300 ultrasonic scalpel system (Johnson & Johnson, USA), a laparoscopic linear cutter stapler (Johnson & Johnson, USA), a laparoscopic ultrasound device, LigaSure, bipolar coagulation, titanium laparoscopic clips, and absorbable hemostatic gauze.
16037531|NCT02613130|Drug|Stannous fluoride toothpaste|
16037532|NCT02613130|Drug|Potassium nitrate toothpaste|
16037533|NCT02613117|Device|Potassium Oxalate Gel|Self applied
16037534|NCT02613117|Device|Potassium Oxalate Liquid|Professionally Applied
16037535|NCT02613117|Drug|Stannous fluoride paste|SnF2 Paste
16037536|NCT02613104|Other|emotion recognition modification - sad>happy|Participants must choose whether each face is happy or sad. Based on these responses, an algorithm then estimates each participant's balance point, the threshold point on the morph sequence at which they are equally likely to label the face as happy or sad. During the intervention, the participant receives feedback on their emotion choices designed to train them to identify two additional morphs as happy, rather than sad. The intervention is completed three times.
16037537|NCT02613104|Other|emotion recognition modification - sad>happy control|Participants must choose whether each face is happy or sad. Based on these responses, an algorithm then estimates each participant's balance point, the threshold point on the morph sequence at which they are equally likely to label the face as happy or sad. During the placebo intervention, the participant receives feedback on their emotion choices designed to reinforce their initial emotion choices. The placebo intervention is completed three times.
16037538|NCT02613104|Other|emotion recognition modification - angry>happy|Participants must choose whether each face is happy or angry. Based on these responses, an algorithm then estimates each participant's balance point, the threshold point on the morph sequence at which they are equally likely to label the face as happy or angry. During the intervention, the participant receives feedback on their emotion choices designed to train them to identify two additional morphs as happy, rather than angry. The intervention is completed three times.
16037539|NCT02613104|Other|emotion recognition modification - angry>happy control|Participants must choose whether each face is happy or angry. Based on these responses, an algorithm then estimates each participant's balance point, the threshold point on the morph sequence at which they are equally likely to label the face as happy or angry. During the placebo intervention, the participant receives feedback on their emotion choices designed to reinforce their initial emotion choices. The placebo intervention is completed three times.
16037540|NCT02613091|Drug|Clemastine fumarate|4mg 2x day clemastine fumarate orally.
16037579|NCT02612857|Drug|Placebo|normal saline subcutaneous injections once a week for 24 weeks.
16037580|NCT02612844|Drug|NNC0143-0406|Subject will receive one single dose only Subcutanesously (s.c., under the skin)
16041125|NCT02588079|Behavioral|Internet-based cognitive behavioral therapy|
16037541|NCT02613078|Behavioral|Gut-Directed Hypnotherapy|Hypnotherapy protocol is based on the Manchester protocol for gut-directed hypnotherapy and was adapted for children and adolescents. It consists of elements aiming at relaxation and suggestions for control and relief from pain and discomfort. The hypnotherapy will be provided using a CD. Children of the hypnotherapy condition will be instructed to practice with their CD on a daily basis (20 min each day, at least 4 times/week) during 4 weeks
16037542|NCT02613078|Dietary Supplement|Nutritional Supplement|SymbioLact® B a preparation of Bifidobacterium lactis and vitamin B7, Biotin. Number of living organisms in one dose is at least 1 x 10^9 cfu. SymbioLact® B will be used in the dose recommended in the pediatric patient information sheet - one dose of SymbioLact® B diluted in water or tee once a day together with a main meal during 4 weeks
16037543|NCT02613078|Behavioral|Self-Monitoring|Use of symptom diary that questions about main bowel complains (including pain or discomfort) during the day. Applied on a daily basis (about 2 min in the evening)
16037544|NCT02613065|Dietary Supplement|Consumption of NOW Foods eggwhite protein shake|Consumption of NOW Foods egg white protein shake at beginning of 3 daily meals that in total, is approximately 20% of caloric needs.
16037545|NCT02613065|Dietary Supplement|Consumption of NOW Foods maltodextrin shake|Consumption of NOW Foods maltodextrin shake at beginning of 3 daily meals that in total, is approximately 20% of caloric needs.
16037546|NCT02613052|Drug|normal saline|10 mL of normal saline agitated prior to IV administration
16037547|NCT02613052|Drug|human albumin|10 mL of 5% albumin agitated prior to IV administration
16037548|NCT02613052|Drug|human albumin and propofol|7 mL of 5% albumin mixed with 3 mL of propofol (10 mg/mL) agitated together prior to IV administration
16037549|NCT02613039|Drug|Combined Estrogen-Progestin Oral Contraceptives|All patients enrolled will undergo Combined Estrogen-Progestin Oral Contraceptives. Different compounds will be chosen according to the approved indications and clinical practice. Therefore it is not possible to provide a specific trade and/or generic name.
16037550|NCT02613026|Drug|Pirarubicin|
16037551|NCT02613026|Drug|Docetaxel|
16037552|NCT02613026|Drug|Cyclophosphamide|
16037553|NCT02613013|Device|neodymium:yttrium-aluminum- garnet laser|a neodymium:yttrium-aluminum- garnet laser was used to perform the LPI
16037554|NCT02613013|Device|frequency-doubled Q-switched neodymium:yttrium-aluminum-garnet 532-nm laser|a frequency-doubled Q-switched neodymium:yttrium-aluminum-garnet 532-nm laser was used to perform the LPIP
16037555|NCT02613013|Drug|Pilocarpine|30 minutes prior to the procedure, a drop of 2% pilocarpine will be instilled into the eye every 15 minutes, Topical anaesthesia (Proparacaine) will be administered
16037556|NCT02613013|Procedure|LPIP plus LPI|LPIP was applied with a VISULAS diode laser of 532 nm (Carl Zeiss Meditec, Dublin, CA). 30 minutes prior to the procedure, a drop of 2% pilocarpine will be instilled into the eye every 15 minutes, Topical anaesthesia will be administered. Twenty to 30 spots of 250-300 mW power with 300-500 microns of size and duration of 400-500 ms were applied. Power was modified arbitrarily until an effective iris contraction was obtained. Effective iris contraction was considered as a concentric movement around the laser spot, with minimal iris pigmentation and immediate angle opening observed through the lens mirrors using a Goldmann lens. Power was lowered if there was any bursting sound perceived, pigment dispersion, air bubbles or considerable pain. LPI was performed after LPIP procedure.
16037557|NCT02613013|Drug|Proparacaine|30 minutes prior to the procedure, a drop of 2% pilocarpine will be instilled into the eye every 15 minutes, Topical anaesthesia (Proparacaine) will be administered
16037558|NCT02613013|Procedure|LPI|LPI was performed with a VISULAS diode laser of 532 nm (Carl Zeiss Meditec, Dublin, CA). 30 minutes prior to the procedure, a drop of 2% pilocarpine will be instilled into the eye every 15 minutes, Topical anaesthesia (Proparacaine) will be administered. The treatment site was selected in the superior nasal iris or in a crypt, where present. Treatment was initiated with a pulse of 3-5mJ, the power was increased until patency was achieved, the opening of iris >0.1mm. and patency was determined by direct visualization of the posterior chamber.
16037559|NCT02613000|Other|No intervention|
16037560|NCT02612987|Behavioral|Internet-based Cognitive Behaviour Therapy (iCBT)|
16037561|NCT02612974|Biological|Hirudinaria granulosa, qurse mafasil|compare the efficacy of both groups
16037562|NCT02612961|Other|3mL of normal saline from the pink sodium chloride bullet|
16037563|NCT02612961|Other|Sham Comparator of 3mL normal saline|
16037564|NCT02612948|Drug|Quetiapine|escalating dose to prevent delerium.
16037565|NCT02612935|Device|Lumosity|Lumosity offers a suite of online games focused on stimulating cognitive domains of attention, memory, cognitive flexibility, problem solving, and speed of processing. The Lumosity program may be well suited for cognitive remediation in individuals with MS.
16037566|NCT02612922|Drug|Nitazoxanide|Nitazoxanide 600 mg administered orally twice daily for five days
16037567|NCT02612922|Drug|Placebo|Placebo administered orally twice daily for five days
16037568|NCT02612909|Biological|IVACFLU-A/H5N1 vaccine|Monovalent A/H5N1 influenza vaccine (MIV), whole virion inactivated, purified by sucrose gradient on ultracentrifuge. The vaccine was produced in eggs, inactivated with formaldehyde, and formulated with aluminum hydroxide 0.6 mg/0.5 mL with no preservative.
16037569|NCT02612909|Biological|Placebo|Includes 4.500mg sodium chloride, 0.685 mg sodium phosphate dibasic dihydrate, and 0.186 mg sodium phosphate monobasic dihydrate.
16037570|NCT02612896|Drug|Mass drug administration, praziquantel 10mg/kg|see previous, in elimination study arm only
16037571|NCT02612896|Behavioral|Health education|in all study arms, using village meetings, posters, pamphlets.
16037572|NCT02612870|Device|Sienna+ retro|Sentinel node marking with Sienna+ retro-mamillary 1 day before surgery
16037573|NCT02612870|Device|Sienna+ peri|Sentinel node marking with Sienna+ peri-tumorally 1 day before surgery
16037574|NCT02612870|Device|Sienna+ retro 4-6|Sentinel node marking with Sienna+ retro-mamillary 4-6 days before surgery
16037575|NCT02612870|Device|Sienna+ peri 4-6|Sentinel node marking with Sienna+ peri-tumorally 4-6 days before surgery
16037576|NCT02612870|Device|Technetium 1|Sentinel node marking with Technetium 1 day before surgery
16037577|NCT02612857|Drug|IMO-8400 Dose Group 1|IMO-8400 Dose 1 subcutaneous injections once a week for 24 weeks.
16037578|NCT02612857|Drug|IMO-8400 Dose Group 2|IMO-8400 Dose 2 subcutaneous injections once a week for 24 weeks.
16042929|NCT02575677|Other|oxycodone|oxycodone 0,1/kg up to 10 mg sc.
16037581|NCT02612844|Drug|insulin aspart|Subject will receive one single dose only. Subcutanesously (s.c., under the skin)
16037582|NCT02612831|Procedure|Early bariatric surgery|
16037583|NCT02612831|Procedure|Delayed bariatric surgery|
16037584|NCT02612818|Device|Coelioscopy|
16037585|NCT02612805|Other|Aerobic training|Total duration of exercise sessions: 56 minutes (3 minutes of warming - 50 minutes of main part - 3 minutes of stretching); Method of training: Aerobic continuous in aquatic environment; Modality: Hydrogymnastics; Weekly frequency: 3; Intensity: 85% to 100% of the anaerobic threshold during the intervention.
16037586|NCT02612805|Other|Combined training|"Total duration of exercise sessions: 56 minutes (3 minutes of warming - 50 minutes of main part - 3 minutes of stretching); Method of training: Aerobic more resistance training.
~Aerobic component (between 30 and 40 minutes of the sessions): Method: Aerobic continuous in aquatic environment; Modality: Hydrogymnastics; Weekly frequency: 3; Intensity: 85% to 100% of the anaerobic threshold during the intervention.
~Resistance component (Between 10 and 20 minutes of the sessions): Method: Multiple sets (2 to 4 sets of 30 to 15 seconds) in aquatic environment; Modality: Hydrogymnastics; Weekly frequency: 3; Intensity: Maximum execution speed."
16037587|NCT02612805|Other|Training placebo|Total duration of exercise sessions: 56 minutes (3 minutes of warming - 50 minutes of main part - 3 minutes of stretching); Activities performed in main part: Stretching and relaxation in aquatic environment.
16037588|NCT02612792|Procedure|Open flap debridement (OFD)|Open flap debridement (OFD) alone
16037589|NCT02612792|Procedure|OFD with Platelet rich fibrin (PRF)|Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement
16037590|NCT02612792|Procedure|OFD with Platelet rich fibrin (PRF)+1.2% Atorvastatin (Drug) in gel form|Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1.2% Atorvastatin gel placement
16037591|NCT02612779|Drug|Elotuzumab|
16037592|NCT02612779|Drug|Pomalidomide|
16037593|NCT02612779|Drug|Dexamethasone|
16037594|NCT02612779|Drug|Nivolumab|
16037595|NCT02612766|Dietary Supplement|Pure, uncontaminated oats|
16037596|NCT02612753|Procedure|improvement of language for aphasics patients|Aphasics patients receive active stimulation during SLT
16037597|NCT02612753|Device|Sham tDCS|Aphasics patients control receive sham stimulation during SLT
16037598|NCT02612753|Device|tDCs|
16037599|NCT02612740|Biological|Deproteinized bovine bone|cyst removal followed by heterologous bone grafting
16037600|NCT02612740|Device|granules of deproteinized bovine bone (Bio-Oss)|
16037601|NCT02612727|Device|Filtered-sunlight phototherapy|Infants will receive >= four hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using Air Blue 80 window tinting film.
16037602|NCT02612727|Device|Intensive phototherapy|Infants will receive >= four hours per day of intensive phototherapy for 1 to 10 days.
16037603|NCT02612714|Drug|Rosuvastatin|All parameters were measured before statin treatment, after 6 months of statin treatment and 6 months after discontinuing statin treatment. Scores of the sexual health inventory for men (SHIM) were also evaluated.
16037604|NCT02612701|Other|Cigarettes|Subjects will smoke a standard cigarette (yield: tar 12 mg, nicotine 1 mg)
16037605|NCT02612701|Other|E-cigarettes (nicotine free e-liquid)|Subjects will smoke nicotine free e-liquid with an e-cigarette.
16037606|NCT02612701|Other|E-cigarettes (low nicotine e-liquid)|Subjects will smoke low nicotine (4-6 mg/mL) e-liquid with an e-cigarette.
16037607|NCT02612701|Other|E-cigarettes (high nicotine e-liquid)|Subjects will smoke low nicotine (18-24 mg/mL) e-liquid with an e-cigarette.
16037608|NCT02612688|Behavioral|ACP Video Program|The ACP Video Program consists of five videos that address ACP decisions: (1) General Goals of Care, (2) Goals of Care for Advanced Dementia, (3) Hospice, (4) Hospitalization, and (5) ACP for Healthy Patients. NH staff will offer videos to patients at these clinical triggers: (1) Within 7 days of admission or readmission; (2) Every 6 months for long-stay patients; (3) When there is a significant change in clinical status; (4) When a treatment decision arises for which there is a specific video; and (5) Special circumstances when goals of care are being considered (e.g., family visiting).
16037609|NCT02612675|Other|ONS|
16037610|NCT02612662|Drug|AZD4076|Subcutaneous (SC) administration of single ascending doses; there will be no more than 2 mL per syringe/injection
16037611|NCT02612662|Drug|Placebo|Subcutaneous (SC) administration of single ascending doses; there will be no more than 2 mL per syringe/injection
16037612|NCT02612649|Drug|Ramosetron|Oral
16037613|NCT02612636|Other|ear plug|The patients will receive the intervention (ear plug) in the third night (N3) from 9 pm to 6 am.
16037614|NCT02612636|Other|eye mask|The patients will receive the intervention (eye mask) in the second night (N2) from 9 pm to 6 am.
16037615|NCT02612623|Drug|Gefapixant|Gefapixant tablets administered by mouth twice daily for 8 weeks
16037616|NCT02612623|Drug|Placebo (for gefapixant)|Matching placebo to gefapixant tablets administered by mouth twice daily for 8 weeks
16037617|NCT02612610|Drug|Gefapixant|Gefapixant administered as one 7.5 mg, 20 mg, or 50 mg tablet twice daily, depending upon randomization.
16037618|NCT02612610|Drug|Placebo (for gefapixant)|
16037619|NCT02612597|Other|Bedrest|
16037620|NCT02612597|Other|Exercise Training|
16037621|NCT02612584|Device|Pinhole Soft Contact Lens apply for presbyopia|
16037622|NCT02612558|Drug|Fostamatinib 150 mg bid|Fostamatinib 150 mg bid. The dose of Fostamatinib may be reduced at any time to as low as 100 mg PO once daily (qd) if dose limiting adverse events are observed.
16037623|NCT02612545|Drug|Dihydroartemisinin-piperaquine (DHA-PPQ)|Co-formulated anti-malarial drug used as standard of care treatment for uncomplicated malaria in Cambodia
16037624|NCT02612545|Drug|Mefloquine (MQ)|ACT partner drug
16037625|NCT02612532|Device|ReCIVA breath sampler|Device developed for standardised collection of breath samples http://www.owlstonenanotech.com/medical/products/reciva
16037626|NCT02612519|Device|Alfapump|Implantation of Alfapump
16037627|NCT02612519|Device|TIPS|Implantation of TIPS
16037628|NCT02612506|Drug|Hepalatide|There are seven cohorts as follows 0.21mg, 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg. Dose of 0.21mg is a pilot trial with no placebo. At each dose level, healthy volunteers will be received treatment drug by abdominal subcutaneous injection at the first day and monitored for 8 days.
16037909|NCT02610556|Drug|Docetaxel|Docetaxel 60 mg/m2, D1 every 3 weeks for 3 cycles
16037629|NCT02612506|Drug|Placebo|There are six cohorts as follows 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg. At each dose level, healthy volunteers will be received control drug by abdominal subcutaneous injection at the first day and monitored for 8 days.
16037630|NCT02612493|Other|Obese patients with type I diabetes|Postsurgical follow - up in obese patients with type I diabetes
16037631|NCT02612480|Drug|ticagrelor|7 day treatment of ticagrelor 2dd90mg after a loading dose of 180mg
16037632|NCT02612480|Drug|Clopidogrel|7 day treatment of clopidogrel 1d75mg after a loading dose of 300mg
16037633|NCT02612480|Drug|Acetylsalicylic acid lysinate|7 day treatment of acetylsalicyclic acid 1d80mg after a loading dose of 160mg
16037634|NCT02612480|Drug|Placebo|7 day treatment with placebo
16037635|NCT02612467|Other|Stratified care|"Patients are stratified according to the SBT subgroups (low, medium and high risk) and the appropriate matched intervention will be delivered accordingly.
~Low risk: Reassuring information. Onwards referral, investigation or further treatment is not recommended Medium risk: In addition to reassuring information patients receive evidence based individualised treatment focusing on restoring function (targeting back pain, leg pain, co-morbid pain and disability) High risk : In addition to medium risk treatment patients will receive individualised psychologically informed physiotherapy aiming to reduce pain and disability."
16037636|NCT02612467|Other|Current care|Treatment based on clinical judgement, clinical need and patient preferences. No access to guidance tools.
16037637|NCT02612454|Drug|Dupilumab|Weight-tiered dosing administered subcutaneous (SC)
16037638|NCT02612441|Device|real Acupuncture Needles|Acupuncture needles
16037639|NCT02612441|Device|sham Acupuncture Needles|sham Acupuncture Needles
16037640|NCT02612428|Biological|ELAD System|An extracorporeal human hepatic cell-based liver treatment
16037641|NCT02612428|Other|Standard of Care (Control)|Standard medical treatment as defined by the protocol
16037642|NCT02612415|Device|Treatment strategy: Non-invasive respiratory support delivered via high flow nasal cannula|A heated, humidified, HFNC device will be used to deliver a gas flow rate of 2 L/kg/min for the duration that the patient needs non-invasive respiratory support
16037643|NCT02612415|Device|Treatment strategy: Non-invasive respiratory support delivered via continuous positive airway pressure|CPAP will be provided using a set expiratory pressure of 6-8 cm water (H2O) pressure for the duration that the infant needs non-invasive respiratory support
16037644|NCT02612402|Device|messages generated by learning algorithm|THIS INTERVENTION HAS BEEN INCLUDED IN THE LEARNING ALGORITHM ARM The app measures physical activity by the phone accelerometer and sends SMS messages to encourage activity. An automatic learning algorithm for encouraging physical activity learns the patterns of response for each patient and chooses the best messages for the patient to encourage activity.
16037645|NCT02612402|Device|constant weekly message reminding patient to exercise|THIS INTERVENTION HAS BEEN INCLUDED IN THE CONTROL ARM The app measures physical activity by the phone accelerometer and sends a constant SMS messages to remind the patient to exercise.
16037646|NCT02612389|Other|Meditative Movement taught via DVD|Gentle movement with attention to posture and breathing with emphasis on interoceptive awareness and self regulation.
16037647|NCT02612363|Drug|Dexmedetomidine for sedation|"Dexmedetomidine or control drug for sedation
~Analgesia
~Propofol at lowest dosage.
~Dose range: 0.1- 0.7 u/kg/hour
~Target RASS score of -2 to +1
~Supplemental other sedatives at lowest effective dose"
16037648|NCT02612350|Genetic|ctDNA Analysis for the Detection of Genetic Mutations|Cell-free DNA (cfDNA) is isolated from a blood plasma sample and tested for the presence of 96 specific well-described mutations in 9 cancer driver genes. The presence of more than 2 copies of a mutation may indicate the presence of a malignancy. Follow up with the subject's physician would be needed for an examination and any additional testing that the physician wants to perform to further assess for the development of cancer.
16037649|NCT02612337|Drug|OTO-104|Single intratympanic injection of 12 mg OTO-104
16037650|NCT02612337|Drug|Placebo|Single intratympanic injection of placebo
16037651|NCT02612324|Behavioral|Pono Choices|Medically accurate teen pregnancy and STI prevention education delivered through a place-based framework integrating Hawaiian cultural activities that draw upon both historical and local references.
16037652|NCT02612324|Behavioral|Business as Usual|Teen pregnancy and STI prevention education left to the discretion of the school.
16037653|NCT02612311|Biological|Obinutuzumab|Obinutuzumab: IV infusion
16037654|NCT02612311|Biological|Ublituximab|Ublituximab: IV infusion
16037655|NCT02612311|Drug|TGR-1202|TGR-1202: Oral daily dose
16037656|NCT02612311|Drug|Chlorambucil|Chlorambucil: Oral dose
16037657|NCT02612298|Drug|Arotinolol Hydrochloride|Arotinolol Hydrochloride, oral, 5-15mg, bid for 12 weeks.
16037658|NCT02612298|Drug|Metoprolol succinate sustained-release tablet|Metoprolol succinate sustained-release tablet,oral, 23.75-71.25mg, qd for 12 weeks.
16037659|NCT02612285|Drug|SNX-5422|Capsule(s) dosed every other day for 21 days (total 11 doses) out of a 28-day treatment cycle
16037660|NCT02612272|Drug|Ketorolac|intra-articular ketorolac
16037661|NCT02612272|Drug|Betamethasone|intra-articular betamethasone
16037662|NCT02612259|Dietary Supplement|TRYPTOPHAN|at the dose of 3,5 m/kg/ day divided in two capsules
16037663|NCT02612259|Other|PLACEBO|at the dose of 3,5 m/kg/ day divided in two capsules
16037664|NCT02612246|Drug|GLPG1972 single ascending doses|single dose, oral solution
16037665|NCT02612246|Drug|Placebo single dose|single dose, oral solution, matching placebo
16037666|NCT02612246|Drug|GLPG1972 multiple ascending doses|multiple doses, daily for 14 days, oral solution
16037667|NCT02612246|Drug|Placebo multiple doses|multiple doses, daily for 14 days, oral solution
16037668|NCT02612233|Drug|Pregabalin or Duloxetine or Placebo|This is a randomized, double blind placebo controlled trial with a head-to-head comparison of duloxetine vs pregabalin vs placebo over-encapsulated to prevent unblinding of treatment arm
16037669|NCT02612220|Procedure|BioFoam® Surgical Matrix|Complete hemostasis is achieved by direct application of BioFoam® (Cryolife Inc., Kennesaw, GA) to the transection surface area of the liver. In addition, the surgeon may use conventional methods such as argon beam coagulation and warm sponges. If more than one syringe of BioFoam® is required to cover the entire transection surface area, a second syringe maybe used. BioFoam® Surgical Matrix will be used according to the supplier's instructions.
16037670|NCT02612220|Other|Conservative hemostasis|Complete hemostasis will be achieved without the use of topical agents
16037671|NCT02612207|Device|Bilirubin Binding Capacity by Hematofluorometry Validation|Observation study
16037672|NCT02612194|Drug|Crizotinib|Crizotinib was administered orally at 250mg twice daily
16037673|NCT02612181|Drug|Dexmedetomidine for dexmedetomidine group|The effect of dex and placebo for sedation on microcirculation
16037674|NCT02612168|Device|Melanoma Image Analysis Algorithm (MIAA)|The images will be analysed by MIAA (Melanoma Image Analysis Algorithm). The MIAA result for PLs that are biopsied will be compared to the diagnosis made from the biopsy. The MIAA result for PLs not biopsied will be compared to clinician diagnosis.
16037675|NCT02612155|Biological|Infusion of autologous cord blood|Infants who meet study enrollment criteria will receive up to 2 infusions of their own volume reduced cord blood cells. The number of doses will be determined by the amount of available cord blood cells.
16037676|NCT02612155|Biological|Placebo|Infants who meet study enrollment criteria will receive up to 2 placebo infusions composed of an equivalent volume (volume of product that would have been administered if the infant randomized to the intervention arm) of packed red blood cells (PRBCs) from the red cell compartment of the separated cord blood unit.
16037677|NCT02612142|Behavioral|physical exercise|endurance-training or stretching (sham exercise)
16037678|NCT02612129|Drug|arimoclomol|
16037679|NCT02612129|Drug|Placebo|
16037680|NCT02612116|Drug|Pulverized ticagrelor sublingually|Pulverized ticagrelor (180 mg) administered sublingually
16037681|NCT02612116|Drug|Pulverized ticagrelor orally|Pulverized ticagrelor (180 mg) administered orally
16037682|NCT02612116|Drug|Integral ticagrelor|Integral ticagrelor (180 mg) administered orally
16037683|NCT02612090|Dietary Supplement|Active Treatment Beverage|Strawberry
16037684|NCT02612090|Dietary Supplement|Placebo Treatment Beverage|Placebo
16037685|NCT02612077|Other|Observational Chemotherapy|No intervention - Observational standard practice chemotherapy
16037686|NCT02612077|Drug|Concomitant Bevacizumab|No intervention - Observational concomitant bevacizumab
16037687|NCT02612064|Device|Stannous Fluoride dentifice|Experimental dentifrice containing 0.454% w/w stannous fluoride (1100ppm)
16037688|NCT02612064|Other|Sodium Monofluorophosphate dentifrice|Dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride)
16037689|NCT02612051|Drug|GSK3008348 Nebuliser solution|Nebuliser solution formulated at 5000 mcg/mL with 5% mannitol, citric acid, sodium citrate and water for injection, pH adjusted using Hydrochloric acid or Sodium hydroxide to the target pH 5.4 +/- 0.4. 4 ml of diluted dose of appropriate concentration will be administered by nebulisation.
16037690|NCT02612051|Drug|Placebo Nebuliser solution|5% mannitol nebuliser solution. 4 ml of solution will be administered by nebulisation
16037691|NCT02612051|Radiation|GSK26346763: ([18F]-FBA-A20FMDV2) IV infusion|Formulated in 0.9% saline. The maximum amount of radioactivity injected during each PET scan will be 150 Megabecquerel (MBq) and maximum mass of [18F]-FBA-A20FMDV2 administered across all three administrations will be 100 mcg. Intravenous bolus infusion of 20 ml will be administered over about 30 seconds.
16037692|NCT02612038|Device|Expiratory resistance|Generic expiratory resistance will be added to the patient's respiratory circuit
16037693|NCT02612038|Device|Sham expiratory resistance|Sham expiratory resistance will be added to the patient's respiratory circuit
16037694|NCT02612025|Behavioral|Exercise Training|Exercise training during intensive medical treatment. Training mainly composed of endurance and resistance exercises. 3 to 5 times per week for six weeks.
16037695|NCT02612012|Radiation|axillary radiotherapy|Whole breast irradiation and axillary level I-II areas radiotherapy. The prescription dose is 50Gy in 25 fractions in 5 weeks. Tumor bed boost is necessary with 10Gy in 5 fractions in one week.
16037696|NCT02611999|Behavioral|Single median price information|Physicians in this Arm received a single median price in the electronic medical record at the time of ordering in addition to the paper memo.
16037697|NCT02611999|Behavioral|Paired inside/outside price information|Physicians in this Arm received two prices (the inside and outside price) in the electronic medical record at the time of ordering in addition to the paper memo.
16037698|NCT02611986|Device|the McGrath MAC|in a randomised order we evaluate the success rate with the first attempt of the tracheal tube into the trachea.
16037699|NCT02611986|Device|the Macintosh Laryngoscope|in a randomised order we evaluate the success rate with the first attempt of the tracheal tube into the trachea.
16037700|NCT02611973|Other|Aspirin therapy interruption|Stop the treatment by aspirin 100mg/d in the experimental arm.
16037701|NCT02611973|Other|Usual treatment by aspirin 100 mg/d in the active comparator arm|HU+ aspirin maintenance
16037702|NCT02611973|Other|No interruption of aspirin in the Observational arm|patient with Contre indication to aspirin or required antithrombotic therapy
16037703|NCT02611973|Drug|Hydroxyurea treatment (HU)|HU maintenance
16037704|NCT02611960|Biological|Pembrolizumab|IV infusion
16037705|NCT02611960|Drug|Capecitabine|oral tablet
16037706|NCT02611960|Drug|Gemcitabine|IV infusion
16037707|NCT02611960|Drug|Docetaxel|IV infusion
16037708|NCT02611947|Radiation|Low-dose chest CT scans|"Supine chest CT scan after full inspiration. Acquisition parameters: (Topogram 35 mA 120 kV 512 mm length)
~35 quality ref mAs with care-dose ON 120 kV Pitch 1.4 Rotation time 0.33 s Acquired images 64 x 0.6 mm"
16037709|NCT02611934|Procedure|Mild Therapeutic Hypothermia (MHT)|The induction with ice packs and infusion of 0.9% sodium chloride (NaCl) at the temperature of 4˚C. MHT will be maintained with a MTH-dedicated catheter introduced into the inferior vena cava through the femoral vein during PCI. MTH will be maintained for at least 12 hours at target temperature of 33˚C. The rewarming phase will be conducted in an actively controlled manner (0.3˚C per hour). The patient's core temperature will be independently measured in the urinary bladder as well as in the lower one third of the oesophagus using a dedicated catheter and tube. All patients treated with MTH will be mechanically ventilated with a concomitant continuous intravenous infusion of propofol and fentanyl for sedation and analgesia.
16037710|NCT02611921|Drug|Ketamine|Ketamine will be compounded into a mucosal atomization device and self-administered or administered with assistance of a caregiver/study coordinator
16037711|NCT02611921|Drug|Placebo|Placebo will delivered as an atomized saline spray which will be self-administered or administered with assistance of a caregiver/study coordinator
16037712|NCT02611908|Drug|ibrutinib|Cohort 1 420 mg PO daily Cohort 2 560 mg PO daily Cohort 3 700 mg PO daily Cohort 4 840 mg PO daily
16037713|NCT02611908|Drug|obinutuzumab|obinutuzumab 100 mg IV on day 1, 900mg IV on day 2, 1000mg IV day 8, 15, 28 then q 28 days for a total of 8 doses.
16037714|NCT02611895|Biological|HIV DNA|Quantitate the amount of HIV DNA harbored in the cytoplasm of peripheral blood CD4+ T cells
16037715|NCT02611882|Drug|Ga-68 labeled HBED-CC PSMA|The imaging agent (Ga-68 HBED-CC PSMA) will be administered on an outpatient basis. It will be administered a single time intravenously prior to the PET/CT imaging. The one-time nominal injected dose will be 3 to 7 millicurie (mCi) containing 10 - 25 μg Ga-68 HBED-CC PSMA.
16037716|NCT02611882|Device|Positron Emission Tomography (PET) image combined with Computed Tomography (CT) (PET/CT)|Patient shall begin imaging between 55 and 70 minutes after the injection of the radiopharmaceutical. A PET/CT scan includes two parts: a PET scan and a CT scan. The CT portion of the scan produces a 3-D image that shows a patient's anatomy. The PET scan demonstrates function and what's occurring on a cellular level. The PET scan is unique because it images the radiation emitted from the patient while the CT records anatomical x-rays, showing the same area from another perspective
16037717|NCT02611882|Device|Positron Emission Tomography (PET) image combined with Magnetic Resonance Imaging (MRI) (PET/MRI)|Patient shall begin imaging between 55 and 70 minutes after the injection of the radiopharmaceutical. A PET/MRI scan is a two-in-one test that combines images from a positron emission tomography (PET) scan and a magnetic resonance imaging (MRI) scan. Coverage for the scan will extend from the patients vertex through the mid thighs. We will use 4 minute acquisitions per bed position for PET imaging.
16037718|NCT02611869|Procedure|Cryoballoon|Pulmonary vein isolation by cryoablation using a 2nd generation cryoballoon catheter
16037719|NCT02611869|Procedure|RF ablation|Pulmonary vein isolation by radiofrequency current ablation using a touch-force-sensing irrigated catheter
16037720|NCT02611843|Behavioral|Peer-Supported Web CBT|
16037721|NCT02611843|Behavioral|Self-Managed Web CBT|
16037722|NCT02611830|Drug|Vedolizumab 300 mg IV|Vedolizumab intravenous infusion
16037723|NCT02611830|Drug|Placebo IV|Vedolizumab intravenous infusion placebo
16037724|NCT02611830|Drug|Vedolizumab 108 mg SC|Vedolizumab subcutaneous injection
16037725|NCT02611830|Drug|Placebo SC|Vedolizumab subcutaneous injection placebo
16037726|NCT02611817|Drug|Vedolizumab SC 108 mg|Vedolizumab SC Injection.
16037727|NCT02611817|Drug|Placebo|Vedolizumab placebo-matching SC injection.
16037728|NCT02611817|Drug|Vedolizumab IV 300 mg|Vedolizumab IV Injection.
16037729|NCT02611804|Drug|Diclofenac sodium|
16037730|NCT02611804|Drug|Diclofenac sodium|
16037731|NCT02611804|Drug|Placebo|
16037732|NCT02611791|Device|Radiofrequency|The application of RF was through Tecatherap-VIP unit (VIP-Eletromedicina, Argentina) with bipolar method, using a gauntlet of 2cm, and the coupling electrode, which was located in the sacral region (fig x). For the application, participants were placed in a supine position with legs in lithotomy position, it was used water soluble gel for coupling and slide of the gauntlet. The application in external labia majora was made in the caudal-cranial direction, with constant movement and electrode lightly pressed. (fig) During the session, the heat level was monitored verbally and by infrared digital thermometer. The intensity was gradually increased, and at the time when the temperature reached values between 39-41ºC, the intensity was reduced two points and the procedure was maintained for two minutes.
16037733|NCT02611791|Device|Radiofrequency - OFF|The treatment protocol for the control group was identical, differing only in relation to the RF equipment, which was turned off, but a water-soluble gel was used, heated by a resistor, preventing the patient from knowing to which group she belonged. Just the physiotherapist who performed the procedure knew which group the patient belonged to.
16037734|NCT02611778|Biological|ranibizumab|
16037735|NCT02611765|Drug|Benzathine penicillin G intramuscular 7.2 million units|Three doses of intramuscular 2.4 million units of benzathine penicillin G administered weekly (a total of 7.2 million units).
16037736|NCT02611765|Drug|Benzathine penicillin G intramuscular 2.4 million units|A single dose of intramuscular 2.4 million units of benzathine penicillin G
16037737|NCT02611752|Drug|CAM2038|CAM2038 subcutaneous injection
16037738|NCT02611739|Device|Medi-Port|Treatment
16037739|NCT02611739|Device|Medi-Port|Control
16037740|NCT02611726|Other|Acupuncture|Acupuncture
16037741|NCT02611700|Drug|Nimotuzumab|400mg,day1,weekly,until disease progression or toxicity
16037742|NCT02611700|Drug|Paclitaxel|175mg/m^2,for 3 hour(Peripherally Inserted Central Catheter,PICC),day1,21 days for a cycle ,until disease progression or toxicity，maximum duration is 6 cycles.
16037743|NCT02611700|Drug|Cisplatin|60mg/m^2,day1，21 days for a cycle ,until disease progression or toxicity,maximum duration is 6 cycles.
16037744|NCT02611700|Drug|Placebo|400mg,day1,weekly,until disease progression or toxicity
16037745|NCT02611687|Drug|pitolisant|Tablet
16037746|NCT02611687|Drug|Placebo|Tablet
16037747|NCT02611661|Device|PET/MRI|
16037748|NCT02611661|Radiation|Percutaneous ablation|
16037749|NCT02611661|Radiation|Stereotactic body radiotherapy|
16037750|NCT02611648|Other|Double HLD|Standard high level disinfectant (metricide ortho-phthalaldehyde) with an additional exposure time to disinfect
16037751|NCT02611648|Other|HLD/ETO|Standard high level disinfectant (metricide ortho-phthalaldehyde) followed by ethylene oxide
16037752|NCT02611635|Drug|VKA: Warfarin (Waran)|VKA have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study)
16037753|NCT02611635|Drug|NOAC: Rivaroxaban (Xarelto, BAY59-7939)|NOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study)
16037910|NCT02610556|Drug|Cisplatin 1|Cisplatin 25 mg/m2, D1-3 every 3 weeks for 3 cycles
16037754|NCT02611635|Drug|NOAC: Dabigatran etexilate|NOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study)
16037755|NCT02611635|Drug|NOAC: Apixaban|NOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study)
16037756|NCT02611635|Drug|NOAC: Edoxaban|NOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study)
16037757|NCT02611635|Drug|NOAC: Lixiana|NOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study)
16037758|NCT02611622|Behavioral|LUMA ENT™|
16037759|NCT02611622|Other|Survey|Demographic and Patient Satisfaction Survey
16037760|NCT02611609|Biological|MultiStem|
16037761|NCT02611609|Biological|MultiStem|
16037762|NCT02611609|Biological|Placebo|
16037763|NCT02611596|Drug|Ranolazine|24 weeks of the assigned medication
16037764|NCT02611596|Drug|Placebo|Placebo for 24 weeks
16037765|NCT02611583|Device|TENS|Transcutaneous Electrical Nerve Stimulation
16037766|NCT02611557|Procedure|Manual lymphatic drainage therapy|Patients will undergo a 50 min manual lymphatic drainage (MLD) therapy session by a certified lymphedema therapist. MLD therapy is performed routinely for standard of care in these patients and consists of light massage to facilitate lymphatic fluid mobility.
16037767|NCT02611544|Behavioral|Acceptance and Commitment Therapy|6-week ACT intervention group (n=33)
16037768|NCT02611544|Behavioral|Survivorship Education|6-week survivorship education group (SE; n=32)
16037769|NCT02611544|Behavioral|Enhanced Usual Care|enhanced usual care (EUC; n=26)
16037770|NCT02611531|Behavioral|Video Module Education (VME)|Participants will complete inhaler education on a tablet device
16037771|NCT02611531|Behavioral|Teach-To-Goal (TTG)|Participants will complete intensive in-person inhaler education
16037772|NCT02611518|Drug|Rosuvastatin|Rosuvastatin will be administered as a single oral 10 milligram (mg) dose on Day 1 and Day 14.
16037773|NCT02611518|Drug|JNJ-54861911|JNJ-54861911 will be administered at a dose of 25 mg once daily from Day 8 to Day 17 (in panel 1), Day 8 to 16 (in panel 2).
16037774|NCT02611518|Drug|Metformin|Metformin will be administered as a single oral 500 mg on Day 1 and Day 14.
16037775|NCT02611505|Drug|Esketamine|Esketamine 28 mg will be self-administered by participants as intranasal spray at 0 hour (h) on Day 1.
16037776|NCT02611492|Drug|Nilotinib|400 mg/12h per os D1 to D28 cycles 1-4 300 mg/12h per os D1-D14 interphase
16037777|NCT02611492|Drug|Methotrexate|1 g/m2 continuous Intravenous Infusion (CIV) D1 cycles 2 and 4 25 mg/m2 per os D1, D8 interphase
16037778|NCT02611492|Drug|Aracytine (Ara C)|Age<45 years: 3 mg/m2/12h D2, D3 cycles 2 and 4 Age>=45 years: 1.5 mg/m2/12h D2, D3 cycles 2 and 4
16037779|NCT02611492|Drug|Granulocyte Colony-Stimulating Factor (G-CSF)|5µg/kg/d (SC) D6 until neutrophils > 1 G/L D15 cycles 1 and 3; D6 cycles 2 and 4
16037780|NCT02611492|Drug|Depomedrol|40 mg + methotrexate 15 mg + Aracytine (AraC) 40mg IT cycle 1: D1, D8, D15 IT cycles 2 and 4: D9 IT cycle 3: D1
16037781|NCT02611492|Drug|Dexamethasone|40 mg per os, D1-D2, D8-D9, D15-D16, D22-D23, cycles 1 and 3
16037782|NCT02611492|Drug|Vincristine|2 mg total dose IV, D1 D8 D15 D22 cycles 1 and 3
16037783|NCT02611492|Drug|Imatinib|300 mg/12h per os in post-SCT maintenance therapy for during at least 2 years
16037784|NCT02611492|Drug|6 Mercaptopurine (6MP)|60 mg/m2 per os, D1 to D14, interphase
16037785|NCT02611466|Drug|ASP7962|Participants receive ASP7962 100 mg orally twice daily, in the morning and evening with or without food (approximately 12 hours).
16037786|NCT02611466|Drug|Naproxen|Participants receive naproxen 500 mg orally twice daily, in the morning and evening with or without food (approximately 12 hours).
16037787|NCT02611466|Drug|Placebo|Participants receive matching placebo orally twice daily, in the morning and evening with or without food (approximately 12 hours).
16037788|NCT02611453|Other|"Air contrast cholangiography using carbon dioxide gas"|Carbon dioxide (CO2) will be injected into the biliary tree (which is already exposed to CO2 during routine ERCP) and images will be obtained by using fluoroscopy and digital subtraction imaging (a specific setting on certain fluoroscopy tables).
16037789|NCT02611440|Behavioral|Pharmaceutical care|"Initial interview with pharmacist (at the hospital discharge): Evaluation aimed to identify barriers to adherence to drug treatment followed by an information session on the disease, the benefit of drugs and the importance of diet and lifestyle habits. Pharmacist advices focused on how to take medication and how to manage adverse events will be provided.
~Telephone interviews with hospital clinical pharmacist - patient (at M3 M6 and M9): The objective is to review with the patient its medication-taking routine and its potential difficulties, to motivate adherence to treatment and lifestyle/dietary rules, to give advices about therapeutics and how to take medication.
~HCP contacts CP to determine the prescription refill. Final interview with HCP pharmacist (at M12): The objective is to take stock with the patient about its taking drug load."
16037790|NCT02611427|Behavioral|Education/Self-efficacy|The education/self-efficacy group will 1) receive information about benefits of physical activity and national activity guidelines, 2) receive instruction on how to increase lifestyle walking, 3) use movement monitoring devices, 4) make a walking contract and 5) receive interval contract-directed encouragement from study personnel.
16042930|NCT02575664|Drug|Buprenorphine|Buprenorphine 5 microg/h/7 days
16037791|NCT02611427|Behavioral|Education|The education group will receive information about safe physical activity.
16037792|NCT02611414|Device|anodal tDCS|tDCS anodal stimulation over M1 area applied for 20 minutes at five consecutive days.
16037793|NCT02611414|Device|Sham tDCS|tDCS sham stimulation over M1 applied for 20 minutes (with current turned off at 30 seconds) at five consecutive days.
16037794|NCT02611401|Behavioral|Mindfulness|"The MBI is based on MBSR protocol but in order to maximize the clinical utility in people with MS suffering from depressive symptoms, we will tailor mindfulness intervention on the needs of this specific population. We will apply a modified MBSR protocol integrated with techniques from Sensorimotor Psychotherapy.
~The MBI comprises an 8-week group program. Participants will took part in a 3 hour single weekly sessions, and there will be also an additional all-day session of 7 hours. Each session will cover specific exercises and topics within the context of mindfulness practice and training. Participants will be required to carry out daily 45-min homework assignments, which consist on mindfulness exercises and mindfulness applications in everyday life."
16037795|NCT02611401|Behavioral|Psychoeducation|"The control group is designed to control for the nonspecific elements of the MBI treatment. It will be based on a psycho-educational framework and will include some relaxation techniques. In each session is discussed a MS-related topic. Relaxation and gentle stretching exercises will be proposed at the end of each session. Homework and the material (photocopies, slides, etc.) discussed in group sessions is left to each participant to encourage participants to practice exercises between sessions.
~This intervention will follow the same structure and weekly format of the MBI intervention. The only difference will be the absence of an all-day session."
16037796|NCT02611388|Device|TEAS (transcutaneous electrical acupoint stimulation)|2/10HZ Electric stimulation was given through electrode attached to specific acupoints
16037797|NCT02611388|Device|TEAS (transcutaneous electrical acupoint stimulation)|10/50HZ Electric stimulation was given through electrode attached to specific acupoints
16037798|NCT02611388|Device|fake stimulation|Patients were only attached electrodes without electric current
16037799|NCT02611375|Other|transcranial direct current stimulation|High-definition transcranial direct current stimulation is applied over the hand area of the primary motor cortex (M1). Parameters= 2mA for 20 minutes. Functional task practice will be completed concurrently with tDCS and for approximate 40 minutes after the stimulation stops.
16037800|NCT02611375|Other|peripheral nerve somatosensory stimulation|"Electrical stimulation will be applied to the median nerve of the primary hand being trained at parameters that elicit a sensory but not motor response (called peripheral nerve somatosensory stimulation). Stimulation parameters are 100Hz with a 250uS pulse width. Stimulation intensity will vary between 1-10mA per participant. Stimulation will be applied for 1 hour and functional task practice will be completed concurrent with the stimulation."
16037801|NCT02611375|Other|sham transcranial direct current stimulation|During sham transcranial direct current stimulation (tDCS), a sham tDCS device will be used along with functional task practice. The sham tDCS unit will be used for the first 20 minutes of FTP, followed by an additional 40 minutes of FTP.
16037802|NCT02611362|Behavioral|IMB Gaming Intervention|
16037803|NCT02611336|Drug|Tadalafil|Tadalafil 20 mg to be taken orally once daily, for 5 months
16037804|NCT02611323|Drug|Obinutuzumab|Participants will receive a fixed dose of obinutuzumab, 1000 mg via intravenous (IV) infusion to be given on Days 1, 8 and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6. Cycle length will be 21 days. For eligible participants, post-induction treatment may be given at a dose of 1000 mg via IV infusion on Day 1 of every other month (starting from Month 2) for up to 24 months, until disease progression or unacceptable toxicity.
16037805|NCT02611323|Drug|Rituximab|Participants will receive a fixed dose of rituximab, 375 milligrams per square meter (mg/m^2) via IV infusion to be given on Day 1 of Cycles 1 to 6. Cycle length will be 21 days. For eligible participants, post-induction treatment may be given at a dose of 375 mg/m^2 via IV infusion on Day 1 of every other month (starting from Month 2) for up to 8 months, until disease progression or unacceptable toxicity.
16037806|NCT02611323|Drug|Polatuzumab Vedotin|Participants will receive polatuzumab vedotin via IV infusion at doses of 1.4 or 1.8 milligrams per kilogram (mg/kg) (for FL), and 1.8 mg/kg (for DLBCL) on Day 1 of each 21-day cycle for up to 18 weeks during induction treatment. Polatuzumab vedotin will not be given during the post-induction period.
16037807|NCT02611323|Drug|Venetoclax|Participants will receive venetoclax film-coated tablets at doses of 200, 400, 600, or 800 mg (for FL), and 400, 600, or 800 mg (for DLBCL) on Days 1 to 21 of each 21-day cycle. Post-induction venetoclax may continue for up to 8 months, until disease progression or unacceptable toxicity.
16037808|NCT02611310|Other|No intervention|No intervention administered in this study.
16037809|NCT02611297|Procedure|Cryoprobe|
16037810|NCT02611284|Procedure|LISA|All infants were supported with nCPAP while breathing spontaneously during instillation. A 5Frenchgamma sterilized multi-access catheter specifically designed to deliver surfactants for Neonates was placed 1-2 cm below the vocal cords by direct laryngoscopy without the use of a Magill forceps. Beractant was used as exogenous natural surfactant, (100mg/kg; 4ml/kg) and administered in two aliquots during 1-3 minutes. Positive pressure inflations were given by a mask and bag only if the infant was apneic or bradycardia develops despite the interruption of the procedure. The surfactant administration catheter was removed after surfactant instillation and nCPAP support was maintained. A second dose of surfactant was administered during the first 3 days of life if more than 40% of FiO2 was needed while on nCPAP with at least 6 cm H2O pressure.
16037811|NCT02611284|Procedure|INSURE|"The INSURE technique was performed using Beractant (4ml/kg) after endotracheal intubation. A multi-access catheter for Neonates/Pediatrics designed to deliver surfactants (KimVentTrach Care Technology ®, United Kingdom) was pre-connected to the endotracheal tube and used for surfactant administration without having to disconnect the ventilator. While surfactant was administered all infants were connected to pressure support ventilation modality (PSV) combined with volume guarantee (VG), Dräger ventilator). A tidal volume of 4ml/kg was initially adjusted.
~After surfactant administration, all infants were to be extubated, in accordance with our institutional extubation guidelines, if FiO2< 0.35; for a target Oxygen Saturation (SpO2) of >90%, and if a consistent respiratory effort was present. Extubation was supported with nCPAP in all patients."
16037812|NCT02611271|Other|Monitoring of antibiotic drug removal|No study specific intervention will be performed
16037813|NCT02611258|Drug|Tadalafil|Tadalafil 20 mg to be taken orally once daily, for 5 months
16042931|NCT02575664|Drug|Placebo|Placebo patch
16037814|NCT02611245|Drug|Indocyanine green|This group of patients accepted intravenous injection from 0.5mg / kg to 5mg / kg ICG within 4 to 24 hours before surgery. All patients under general anesthesia to accept conventional thoracoscopy or thoracotomy. After entering the chest using fluorescence thoracoscopy system to collect the fluorescence and white-light images and record the video. After following the routine preoperative planning surgery, the researchers will carefully assess the possibility of the benign and malignant nodules and to communicate with the families of patients. If the patient's family expressed their willingness to dissect the nodules, the researchers will remove this extra pulmonary nodules. Resected specimens will send to routine pathological confirmation compared with the fluorescence results.
16037815|NCT02611232|Drug|Victoza®|Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 24 months.
16037816|NCT02611232|Drug|Placebo|Daily subcutaneous injections with increasing doses up to 1.8 mg per day. Duration of treatment 6 months. Duration of follow-up 24 months.
16037817|NCT02611219|Other|General Health Module-Baseline Adolescent-Self Report (13-18 years)|"38 question questionnaire
~Answers range from 1=all of the time to 5=none of the time"
16037818|NCT02611219|Other|General Health Module-Follow Up Adolescent-Self Report (13-18 years)|"38 question questionnaire about child
~Answers range from 1=all of the time to 5=none of the time"
16037819|NCT02611219|Other|General Health Module-Baseline Parent Report-Adolescent (13-18 years)|"38 question questionnaire about child
~49 question questionnaire about parent
~Answers range from 1-all of the time to 5=none of the time"
16037820|NCT02611219|Other|General Health Module-Follow Up Parent Report-Adolescent (13-18 years)|"38 question questionnaire about child
~49 question questionnaire about parent
~Answers range from 1-all of the time to 5=none of the time"
16037821|NCT02611219|Other|General Health Module-Baseline Parent Report-School Age (5-12 years)|"34 question questionnaire about child
~49 question questionnaire about parent
~Answers range from 1-all of the time to 5=none of the time"
16037822|NCT02611219|Other|General Health Module-Follow Up Parent Report-School Age (5-12 years)|"34 question questionnaire about child
~49 question questionnaire about parent
~Answers range from 1-all of the time to 5=none of the time"
16037823|NCT02611219|Other|Demographic Data Form|-16 questions about demographics such as household income, race, and gender
16037824|NCT02611219|Other|SCT Daily Activity Log|"Uses Fitbit Flex
~Log that lists time in 15 minute increments and allows for checking when out of bed and describing the activity that occurred while out of bed"
16037825|NCT02611219|Other|The Functional Independence Measure for Children|"18-item, 7-level ordinal scale instrument that measures a child's consistent performance in essential daily functional skills. Three main domains (selfcare, mobility, and cognition) are assessed by interviewing or by observing a child's performance of a task to criterion standards
~Categorized into 2 main functional streams: Dependent (ie, requires helper: scores 1-5) and Independent (ie, requires no helper: scores 6-7). Scores 1 (total assistance) and 2 (maximal assistance) belongs to the Complete Dependence category. Scores 3 (moderate assistance), 4 (minimal contact assistance), and 5 (supervision or set-up) belongs to the Modified Dependence category. Scores 6 (modified independence) and 7 (complete independence) belongs to the Independent category."
16037826|NCT02611219|Other|Manual Muscle Testing|"-Isometric muscle strength is tested in specific positions, usually with the muscle at an optimal working length. Using a break test, the test giver overpowers the muscle being tested to determine the muscle grade."
16037827|NCT02611219|Other|3-Minute Step Test|"Using an aerobic step, the participant walks up and down for a given amount of time with the heart rate being checked before and after
~Using the difference in heart rate and a shortness of breath scale, this test is able to give an estimate of aerobic tolerance"
16037828|NCT02611219|Other|HSCT Module-Follow Up Adolescent-Self Report (13-18 years)|"7 question questionnaire about child
~Answers range from 1=all of the time to 5=none of the time"
16037829|NCT02611219|Other|HSCT Module-Follow Child-Self Report (5-12 years)|"10 question questionnaire about child
~Answers range from 1=all of the time to 5=none of the time"
16037830|NCT02611219|Other|HSCT Module-Follow Up Parent Report-adolescent (13-18 years)|"7 question questionnaire about child
~49 question questionnaire about parent
~Answers range from 1=all of the time to 5=none of the time"
16037831|NCT02611219|Other|HSCT Module-Follow Up Parent Report-School Age (5-12 years)|"7 question questionnaire about child
~49 question questionnaire about parent
~Answers range from 1=all of the time to 5=none of the time"
16037832|NCT02611206|Device|Active Repetitive Transcranial Magnetic Stimulation (rTMS)|rTMS applies a pulsatile magnetic field to the scalp which painlessly induces electrical currents to the brain. Typically, rTMS is applied to the dorsolateral prefrontal cortex (DLPFC), a brain region that is hypoactive in depression. Whereas standard rTMS stimulates superficial (1cm depth) cortical areas, recent advances in rTMS coil technology support stimulation of deeper (5 cm depth) limbic structures that are also relevant to depression.
16037833|NCT02611193|Procedure|Manipulative treatment|Manipulative treatment as described by the GBMOIM (Grupo Barcelona de Medicina Ortopédica y Manual) will be perform with extension of the transverse carpal ligament maneuver and fascia release maneuver
16037834|NCT02611193|Procedure|Simulated manipulative treatment|Simulated Manipulative Treatment
16037835|NCT02611180|Procedure|Skin punch biopsy|
16037836|NCT02611180|Procedure|Peripheral blood draw|
16037837|NCT02611167|Biological|Allogeneic bone marrow-derived MSCs (1 x 10 6 MSC/kg)|Bone marrow-derived allogeneic MSCs will be delivered intravenously in escalating doses of 1 x 10 6 MSC/kg, 3 x 10 6 MSC/kg, 6 x 10 6 MSC/kg, or 10 x 10 6 MSC/kg of body weight to a population of patients with idiopathic Parkinson's disease (iPD).
16037838|NCT02611167|Biological|Allogeneic bone marrow-derived MSCs (3 x 10 6 MSC/kg)|Bone marrow-derived allogeneic MSCs will be delivered intravenously in escalating doses of 1 x 10 6 MSC/kg, 3 x 10 6 MSC/kg, 6 x 10 6 MSC/kg, or 10 x 10 6 MSC/kg of body weight to a population of patients with idiopathic Parkinson's disease (iPD).
16037839|NCT02611167|Biological|Allogeneic bone marrow-derived MSCs (6 x 10 6 MSC/kg)|Bone marrow-derived allogeneic MSCs will be delivered intravenously in escalating doses of 1 x 10 6 MSC/kg, 3 x 10 6 MSC/kg, 6 x 10 6 MSC/kg, or 10 x 10 6 MSC/kg of body weight to a population of patients with idiopathic Parkinson's disease (iPD).
16037911|NCT02610556|Radiation|Intensity-modulated radiotherapy|Intensity-modulated radiotherapy
16037912|NCT02610543|Drug|UCB5857|Active Substance: UCB5857 Pharmaceutical form: Capsule Concentration: 5 mg, 10 mg, 30 mg Route of administration: oral
16037840|NCT02611167|Biological|Allogeneic bone marrow-derived MSCs (10 x 10 6 MSC/kg)|Bone marrow-derived allogeneic MSCs will be delivered intravenously in escalating doses of 1 x 10 6 MSC/kg, 3 x 10 6 MSC/kg, 6 x 10 6 MSC/kg, or 10 x 10 6 MSC/kg of body weight to a population of patients with idiopathic Parkinson's disease (iPD).
16037841|NCT02611154|Drug|Testosterone|Participants will self-administer 11 mg 3x daily, for 5 consecutive days for 4 weeks.
16037842|NCT02611141|Procedure|Retromolar laryngoscopy and scoring of the visualisation of the vocal cords according to Cormack & Lehane|"To facilitate the insertion of the straight blade laryngoscope (Miller #4) the head of the patient will be turned to the left side. The blade will be inserted and then pushed laterally rightwards until the retromolar space will be finally reached. Thereafter the epiglottis will be lifted up in order to achieve the best direct view to the vocal cords and scored according to Cormack & Lehane .
~This score will be assessed at least 2 minutes after muscle relaxation:
~Once without a backward, upward, rightwards pressure maneuver (=BURB) and immediately thereafter (i.e. 5-10 seconds later):
~If 100% visualization of the vocal cords is not possible a BURP maneuver will be performed and the scored again.
~Intubation will then be performed by the conventional method using a Macintosh blade #3. In the case that intubation with the conventional method is not successful the retromolar technique will be used."
16037843|NCT02611128|Other|Phenotype/genotype assessment|The investigators will perform careful phenotyping in addition to hormonal assessments and assessments of DENND1A
16037844|NCT02611102|Dietary Supplement|MCT oil + Butter in Coffee|2 tablespoons medium-chain triglyceride oil + 2 tablespoons butter added to 2-4 cups of coffee similar to their usual intake prior to 1200 daily over a 4 week period after a 2 week run-in phase during which the doses of butter and MCT oil will be titrated up (1 Tbsp. of each butter + MCT x 5 days, 2 Tbsp. butter + 1 Tbsp. MCT x 5 days, then 2 Tbsp. of each x 4 days) followed by 6 weeks of washout without treatment.
16037845|NCT02611089|Procedure|Tissue biopsy|Sampling of tissue as described.
16037846|NCT02611076|Behavioral|Stop Smoking for Good Intervention in Spanish (SS-SP)|Assessments will occur at six-month intervals, through 24 months.
16037847|NCT02611076|Behavioral|Usual care (UC)|Assessments will occur at six-month intervals, through 24 months.
16037849|NCT02611050|Behavioral|The Multi-vessel Coronary Artery Disease Option Grid|The Multi-vessel Coronary Artery Disease Option Grid is a patient decision aid used during the clinical visit. It is one page and contains a table a patient's frequently asked questions and the respective information for each treatment strategy. The Multi-vessel Coronary Artery Disease Option Grid was developed using patient and provider feedback and has been field-tested in clinic by cardiologists and surgeons.
16037850|NCT02611050|Behavioral|Usual Care|In usual care clinicians will discuss the patient diagnosis and treatment options typical to routine care for that clinician.
16037851|NCT02611037|Drug|Cisplatin|The recommended dose of cisplatin for transarterial chemoperfusion in this study is 35 mg/m^2 body surface area (BSA). During the lead in phase of the study, 3 patients will be treated with regular doses of cisplatin.
16037852|NCT02611037|Drug|Methotrexate|The recommended dose of methotrexate for transarterial chemoperfusion in this study is 100 mg/m^2 BSA. During the lead in phase of the study, 3 patients will be treated with 50% reduced dose of methotrexate (50 mg/m^2).
16037853|NCT02611037|Drug|Gemcitabine|The recommended dose of gemcitabine for transarterial chemoperfusion in this study is 1000 mg/m^2 BSA. During the lead in phase of the study, 3 patients will be treated with regular doses of gemcitabine.
16037854|NCT02611037|Other|Lung Cancer Symptom Scale for Mesothelioma Questionnaire|Quality of life will be assessed using the modified version of the Lung Cancer Symptom Scale for Mesothelioma questionnaire.
16037855|NCT02611024|Drug|lurbinectedin (PM01183)|lurbinectedin (PM01183) 4 mg vials
16037856|NCT02611024|Drug|Irinotecan|irinotecan 40 mg, 100 mg or 300 mg vials
16037857|NCT02611011|Device|Congo Red Test (GV-005)|The GV-005 is a simple test has been developed to detect unfolded or misfolded proteins in urine.
16037858|NCT02610985|Device|3-D laparoscopy|3-D laparoscopy
16037859|NCT02610985|Device|2-D laparoscopy|2-D laparoscopy
16037860|NCT02610972|Device|Congo Red test GV-005|Congo Red test GV-005 test is a simple test has been developed to detect unfolded or misfolded proteins in urine.
16037861|NCT02610959|Other|Intervention group|The overall aim of the present project is to investigate if intake of cod in pregnancy has impact on infant development up to 12 month.
16037862|NCT02610959|Other|Control group|The overall aim of the present project is to investigate if intake of cod in pregnancy has impact on infant development up to 12 month.
16037863|NCT02610946|Behavioral|Electronic application|Electronic application (app) based intervention to improve adolescent compliance with transplant care and readiness to transition to adult care.
16037864|NCT02610946|Behavioral|Paper-based|Paper-based intervention to improve adolescent compliance with transplant care and readiness to transition to adult care.
16037865|NCT02610933|Drug|rivaroxaban|replacement of vitamin K antagonist by rivaroxaban
16037866|NCT02610933|Dietary Supplement|Vitamin K2|Vitamin K2 supplementation
16037867|NCT02610920|Procedure|Iron-tracer guided axillary ultrasound and biopsy|After ultrasound identifying sentinel lymph nodes, no more than two nodes will be core-needle biopsied and sent to pathology department for analysis of cancer involvement. The biopsied node(s) will be marked for later identification for the surgeons during the regularly scheduled intraoperative sentinel lymph node biopsy (standard of care).
16037868|NCT02610920|Drug|Iron tracer|All participants will receive a 30mg injection of subcutaneous iron sucrose into the breast followed by an axillary ultrasound looking for lymph nodes with enhanced reflexivity.
16037869|NCT02610907|Other|Buffer|The sleeve contains phosphate buffered saline buffer
16037870|NCT02610907|Other|Own output|The sleeve contains the subject own ileal effluent
16037871|NCT02610907|Other|simulated output|The sleeve contains simulated output
16037872|NCT02610894|Other|mHealth application (PoCAH)|Participants will have unlimited access to the mHealth app via iPad Mini for 5 days post-operatively to aid in pain management
16037873|NCT02610894|Other|As usual standard discharge and care instructions|As usual standard discharge and care instructions are provided via iPad mini to orthopaedic ambulatory surgery patients.
16037874|NCT02610881|Dietary Supplement|Iron and Folic Acid (IFA)|1 mg of IFA syrup (containing 20 mg of elemental iron and 100 mcg of folic acid) will be taken twice per week for one month.
16037875|NCT02610881|Dietary Supplement|Micronutrient Powders (MNP)|"One sachet of micronutrient powder will be mixed into food to be taken once daily for a total of one month. One sachet of micronutrient powders includes the following:
~Iron (Ferrous Fumarate) 12.5 mg Zinc (Zinc Gluconate) 5 mg Folic Acid 0.160 mg Vitamin-A (Vit-A Acetate) 0.30mg Vitamin-C (Ascorbic Acid) 30 mg Vitamin-B12 0.9 mcg Iodine 90 mcg Maltodextrin Base"
16037876|NCT02610881|Behavioral|Iron Plus Strategy Counseling|Mothers of participants will receive counseling on the benefits of regular iron intake, side effects associated with IFA administration, and the preservation of the IFA bottle and MNP sachets.
16037877|NCT02610868|Drug|MYOBLOC|After a screening period (up to 21 days), subjects who satisfy all eligibility criteria may receive single dose injections of 3,500 Units of MYOBLOC every 13 weeks (±2 weeks) for a total of 4 treatments via injections into the submandibular and parotid glands. Subjects will undergo safety and effectiveness assessments at Weeks 4, 8, 13, 17, 26, 30, 39, 43, and 52, and telephone follow up will occur at Weeks 21, 34, and 47
16037878|NCT02610855|Procedure|Spinal Fusion Surgery|Participants with severe scoliosis curves requiring spinal fusion surgery.
16037879|NCT02610855|Other|Bracing|Participants with scoliosis curves that require brace treatment for at least the next year. Braces include monitors to record hours of brace wear, as is current standard of care.
16037880|NCT02610855|Device|Tri-axial Accelerometers|Four monitors are place on the participant (waist, thigh, both ankles), attached with straps. Periods of static and dynamic activity are measured based on accelerations in three orthogonal directions for 4 day's time while participating in regular daily activities.
16037881|NCT02610855|Other|Shear Wave Elastography (SWUE)|SWUE is an ultrasound technique for noninvasively evaluating the mechanical properties (stiffness) of skeletal muscle tissue. A commercial ultrasound scanner (Aixplorer from Supersonic Imagine, France) with 2D real time SWUE will be used. The Aixplorer uses ultrasonic push beams to produce shear waves in tissue. The shear wave propagation speed is inherently related to tissue mechanical properties and is used to create a quantitative 2D elastogram of the tissue.
16037882|NCT02610842|Other|Handbook|"The handbook named Hands on - a hand care guide in Systemic Sclerosis contains instructions about the Systemic Sclerosis and hand exercises."
16037883|NCT02610829|Dietary Supplement|Gamma tocopherol|3 doses of 1400 mg gamma tocopherol (2 capsules, each is 700mg), at 12 hour intervals
16037884|NCT02610816|Other|1 Food Elimination Diet|Participants eliminate milk from the diet for 12 weeks
16037885|NCT02610816|Other|4 Food Elimination Diet|Participants eliminate milk, egg, wheat, soy from the diet for 12 weeks
16037886|NCT02610816|Other|4 Food Elimination Diet (post 1FED failure)|Participants that fail to respond to 1FED in phase 1 eliminate milk, egg, wheat, soy from the diet for 12 weeks in Phase 2
16037887|NCT02610816|Drug|Fluticasone Propionate, 800 mcg twice daily (post 4FED failure)|Participants that fail to respond to 4FED in phase 1 administer swallowed glucocorticosteroids (Flovent HFA) 800 mcg twice daily for 12 weeks in Phase 2
16037888|NCT02610777|Drug|Azacitidine|Azacitidine intravenous or subcutaneous formulation.
16037889|NCT02610777|Drug|Pevonedistat|Pevonedistat intravenous infusion.
16037890|NCT02610764|Procedure|Blood Test for CTC evaluation|
16037891|NCT02610738|Behavioral|Junior KICk-OFF education programme|The Junior KICk-OFF course is an age appropriate eduction course which aims to improve the understanding and knowledge of children with type 1 diabetes. It has been designed with school teachers and educationalists to meet the learning needs of children aged 4-11yrs
16037892|NCT02610725|Other|Hatha yoga|Participants will be shown a 30 minute video of a yoga class that they will be invited to follow along with.
16037893|NCT02610712|Drug|Ketamine|
16037894|NCT02610699|Other|Conventional otoscope|The conventional analogue otoscope will be used to provide a two-dimensional view of the ear canal. Clinicians will use this for one month periods for a total of 3 months.
16037895|NCT02610699|Other|Smartphone otoscope|The smartphone otoscope is a pocket size smartphone attachment that uses technology and light source of a smartphone to capture reproducible images of the middle ear and tympanic membrane. Images and videos can be transmitted via real-time communication software from the device to another smartphone. Clinicians will use this for one month periods for a total of 3 months.
16037896|NCT02610686|Drug|Chloroquine|efficacy of chloroquine for the treatment of Plasmodium vivax infections
16037897|NCT02610673|Device|WiCS-LV System|Implant of left ventricular receiver-electrode and ultrasound transmitter.
16037898|NCT02610647|Drug|Wrist anesthesia|Prior to the tapping test, regional anesthesia is performed in the form of sensory blocks distal to the wrist: injection of ropivacaine 7.5mg / ml is carried out successively in contact with three nerves (ulnar, median and radial) with a volume of 2 ml for nerve, for a total of 45mg.
16037899|NCT02610647|Other|Blinding mask|Patients will don a mask that prevents them from seeing during the tapping test.
16037900|NCT02610647|Other|Anti-noise helmet|Patients will don a helmet that prevents them from hearing during the tapping test.
16037901|NCT02610647|Other|Tapping test|"Subjects will be placed at a table in a sitting position where they will perform a rhythmic finger tapping test. The seat height is adjusted so that the front dominant arm rests comfortably on the table. Subjects will be equipped with headphones to receive auditory signals during a first synchronized phase of tapping.
~After the last auditory signal, participants will continue the tapping task by themselves as directed: after the metronome stops,continue tapping the prescribed tempo as accurately and consistently as possible throughout the test. The movements of the index finger will be measured by a single-axis accelerometer (15 × 15 mm) attached to the nail."
16037902|NCT02610621|Procedure|Lumpectomy without sentinel node biopsy|Biopsy of the sentinel node is considered standard of care treatment for women with localized breast cancer. The procedure will be eliminated at time of lumpectomy.
16037903|NCT02610608|Other|ovarian stimulation|evaluation of clincal practice regarding prevention of arterial and venous thrombosis following ovarian stimulation
16037904|NCT02610595|Drug|Jianpixiaozhong particles and Wuse Dietotherapy|Jianpixiaozhong particles: Three packs once,bid po; Wuse Dietotherapy: one packs once,bid po
16037905|NCT02610582|Drug|rAAV.hCNGA3|Single subretinal injection of rAAV.hCNGA3
16037906|NCT02610569|Device|standard endoscopy|standard endoscopy will be either colonoscopy or rectosigmoidoscopy
16037907|NCT02610569|Device|PillCamCOLON (C2)|PillCamCOLON (C2) is a colon video-capsule
16037908|NCT02610556|Drug|Cisplatin 2|Cisplatin 100 mg/m2, D1 every 3 weeks for 3 cycles
16037913|NCT02610543|Drug|Placebo|Active substance: Placebo Pharmaceutical Form: Capsule Route of administration: oral
16037914|NCT02610530|Procedure|Sleeve Gastrectomy with Ileal Transposition|Type 2 diabetic patients who underwent ileal transposition surgery within the last 2 years.
16037915|NCT02610530|Procedure|Sleeve Gastrectomy with Transit Bipartition|Type 2 diabetic patients who underwent transit bipartition surgery within the last 2 years.
16037916|NCT02610530|Other|Medical Treatment|Conventional Non-Surgical Treatment for Glycemic Control group consisted of patients who did not undergo any kind of surgery, and are on medical treatment for type 2 diabetes.
16037917|NCT02610517|Behavioral|Provider Training|All providers will receive an online survey about alcohol pharmacotherapy, and an on-site training on alcohol pharmacotherapy will be offered at UAB and UW. The training will cover the most commonly prescribed alcohol pharmacotherapy. Some medications (ex: Zofran) have been used clinically for alcohol pharmacotherapy but have not yet received FDA approval for this indication. Research has shown these medications are beneficial as alcohol pharmacotherapy and are more frequently used by doctors due to the more favorable side effects. Providers in this study will use their clinical judgment in prescribing alcohol medications per their normal standard of care and using any new information gained from the alcohol pharmacotherapy training.
16037918|NCT02610517|Behavioral|Patient Intervention|Eligible participants will be screened using the Audit and Mini instruments that are routinely asked during regular clinic visits. Once a participant consents, they will be shown 2 computerized brief interventions (CBIs) - one after enrollment (visit 1) and one 3-6 months after enrollment (visit 2). Participants will interact with the touch-screen computer via Peedy the Parrot, a three dimensional animated character. The intervention emphasizes personal responsibility for change, uses empathy as a counseling style, and enhances self-efficacy. At the end of both visits, patients will complete a patient satisfaction survey with questions related to ease of use of CBI and satisfaction with program content. Providers will have the opportunity to prescribe pharmacotherapy at visit 1 and 2.
16037919|NCT02610504|Device|Durolane|single injection of 3ml
16037920|NCT02610491|Dietary Supplement|Hesperidin|Citrus peel extract
16037921|NCT02610491|Dietary Supplement|Placebo|Cellulose
16037922|NCT02610452|Other|Clown therapy|"The clowns intervene by twos: a game takes place.
~The game requires the active presence of a number of potential players in the room (patient, family, caregivers) and takes into account body position, emotional state, the general atmosphere.
~The clowns initiate a game proposal: provisional staging of clown characters based on imagination/improvisation which engages a physicality and a basic emotional state.
~The original game proposal is adjusted according to mutual empathy with those present.
~The game is developed on the model of theatrical improvisation: an original creation that has scenic quality comparable to that of a complete representation. Improvisation time varies depending on the condition of the person, his/her desire to participate, choosing the main theme.
~The final stage of the game is preparing all actors for separation: restitution of roles, revisiting the paths traveled."
16037923|NCT02610439|Other|Laboratory Biomarker Analysis|Correlative studies
16037924|NCT02610426|Other|Laboratory Biomarker Analysis|Correlative studies
16037925|NCT02610413|Other|Laboratory Biomarker Analysis|Correlative studies
16037926|NCT02610400|Combination Product|RACD|"Active malaria surveillance using rapid diagnostic test in households around passively-detected index case. RDT-positive subjects are treated per national policy, under which combination medication artemether-lumefantrine is first-line, using dosing (mg artemether / mg lumefantrine):
~(i) 5-14kg patient: 20/120mg twice (8 hr apart) on day 1, 20/120mg twice (12 hr apart) on each of days 2 and 3 then stop (ii) 15-24kg patient: 40/240mg twice (8 hrs apart) on day 1, 40/240mg twice (12 hrs apart) on each of days 2 and 3 then stop (iii) 25-34kg patient: 60/360mg twice (8 hrs apart) on day 1, 60/360mg twice (12 hrs apart) on each of days 2 and 3 then stop (iv) > 34kg patient: 80/480mg twice (8 hrs apart) on day 1, 80/480mg twice (12 hrs apart) on each of days 2 and 3, then stop"
16037927|NCT02610400|Combination Product|RAVC|Focal, targeted indoor spraying with long-lasting insecticide pirimiphos-methyl or Actellic 300 CS, a World Health Organization (WHO)-approved organophosphate. Safety measures: (i) seeking advance permission to spray; (ii) temporarily removing items (utensils, water, food, pets) from the building during spray; (iii) covering all unremovable items; (iv) asking inhabitants to temporarily relocate outdoors during spray; (v) advising children remain outdoors until floors washed; and (vi) avoiding of spraying of any rooms that contain inhabitants, animals, or incorrectly removed/covered items. Actellic will be applied according to National Vector-borne Disease Control Program (NVDCP) indoor residual spraying (IRS) guidelines, using a Hudson X-pert sprayer (Hudson Manufacturing Co., Chicago, USA) at 40 mL/m-sq.
16037928|NCT02610400|Combination Product|rfMDA|"Presumptive treatment, using the medication A-L, of the inhabitants of households surrounding a passively-detected index case, without incorporating a diagnostic test step. The investigators will administer A-L with dosing as follows (mg artemether / mg lumefantrine):
~(i) 5-14kg patient: 20/120mg twice (8 hours apart) on day 1, 20/120mg twice (12 hours apart) on each of days 2 and 3, then stop (ii) 15-24kg patient: 40/240mg twice (8 hours apart) on day 1, 40/240mg twice (12 hours apart) on each of days 2 and 3, then stop (iii) 25-34kg patient: 60/360mg twice (8 hours apart) on day 1, 60/360mg twice (12 hours apart) on each of days 2 and 3, then stop (iv) > 34kg patient: 80/480mg twice (8 hours apart) on day 1, 80/480mg twice (12 hours apart) on each of days 2 and 3, then stop"
16037929|NCT02610387|Device|Transcranial direct current stimulation (tDCS)|Participants underwent tDCS(2mA) brain stimulation for 20 minutes plus balance training for 20 minutes for 5 consecutive days.
16037930|NCT02610387|Device|Sham tDCS|During sham stimulation, the current ramped up for 30 seconds, ramped back down for 30 seconds, and then remained off for the duration of the stimulation plus balance training for 20 minutes for 5 consecutive days.
16037931|NCT02610374|Other|Agrarian Diet|A diet higher in carbohydrates and lower in fats and sugars
16037932|NCT02610374|Other|Western-type Diet|A diet higher in fats and lower in carbohydrates
16037933|NCT02610361|Drug|BGB-283|"In the dose escalation part(phase 1a): the dose levels will be escalated following a modified 3+3 dose escalation scheme.
~In dose expansion phase(Phase 1b): Patients will be assigned to different groups based on their tumor types"
16037934|NCT02610348|Biological|DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines|Original Vaccine in Study A3L12 (NCT00401531). No vaccination will be administered as part of this study
16037935|NCT02610348|Biological|DTaP-HB-IPV and Pneumococcal polysaccharide vaccines|Original Vaccine in Study A3L12 (NCT00401531). No vaccination will be administered as part of this study
16037936|NCT02610335|Other|Control group (C)|"kyphosis reeducation on Huber platform during 2 weeks,
~patient education : on physiopathology of the lumbar spinal stenosis and treatments as well as healthy lifestyle and prevention (plans of anatomy, plastic column, slides of medical imaging),
~flexibility exercises, stretching exercises and abdominal muscles exercises : to continue at home (the exercises will be reported on a book that will be given to the patient),
~exercises on cycle ergometer or walking on treadmill : to continue at home."
16037937|NCT02610335|Other|Test group|"spinal mobility reeducation on Huber platform during 2 weeks,
~patient education : on physiopathology of the lumbar spinal stenosis and treatments as well as healthy lifestyle and prevention (plans of anatomy, plastic column, slides of medical imaging),
~flexibility exercises and mobilization exercises : to continue at home (the exercises will be reported on a book that will be given to the patient),
~exercises on cycle ergometer or walking on treadmill : to continue at home."
16037938|NCT02610322|Behavioral|Whole soy replacement diet|Participants who are allocated to Whole soy group will receive a 30~40 min counseling session by an experienced nutritionist on: 1) conventional lifestyle education on metabolic syndrome (MetS); 2) The benefits of whole soy diet; 2) Practical techniques to incorporate of 4 servings of whole soy foods (equivalent to 25g soy protein) into their daily diet and reduce high saturated fat and cholesterol rich animal foods based on their prior 7-day dietary record during run-in; (3) Participants will also receive a pamphlet and an 30 min DVD which will provide practical cooking recipes with both illustration and demonstration on how to prepare whole soy foods/diet in an easy and fun way to replace fatty animal meat and dairy products
16037939|NCT02610322|Behavioral|usual diet|Participants who are assigned to the usual diet group (control group) will receive a 5~10 min conventional lifestyle education on MetS by a research staff in which the general recommendation for macronutrient composition of the control diet will be 50-60% of energy as carbohydrate, 15-20% of energy as protein, and <30% of energy as total fat.
16037940|NCT02610309|Behavioral|Family-Based Crisis Intervention|This intensive ED-based intervention with suicidal adolescents and their families includes cognitive behavioral skill building, psychoeducation, enhancing therapeutic readiness, safety planning, and co-creation of a joint crisis narrative.
16037941|NCT02610296|Drug|QPI-1002|IV injection
16037942|NCT02610296|Other|Placebo|isotonic saline
16037943|NCT02610283|Drug|QPI-1002|IV injection
16037944|NCT02610283|Drug|Placebo|isotonic saline
16037945|NCT02610270|Dietary Supplement|2 Gums|760 mg DHA
16037946|NCT02610270|Dietary Supplement|3 Gums|1140 mg DHA
16037947|NCT02610257|Device|Mechanical stimulus (vibration) applied on the forearm|"Local vibration will be applied using a custom-made vibratory system (named Vibrators) consisted of small vibratory devices (constructed using DC micro motors (Faulhaber® - Switzerland) bearing an eccentric load, enclosure on a PVC involucre). Vibrators measure 4.5cm x 2cm x 2cm and weight 27-31g each. Vibrators were custom-made especially for this study and therefore do not have a trade name.
~Vibrators will be positioned either on the extensor carpi radialis brevis (ECRB) muscle belly or on the olecranon region. Devices will be kept in place using regular elbow elastic supports."
16037948|NCT02610244|Other|Modified Cogmed Training|Comparison of outcome measures between treatment-as-usual group and Modified Cogmed Training group after 10 weeks and 3 months follow up.
16037949|NCT02610231|Drug|Istradefylline 20 mg or 40 mg|Istradefylline 20 or 40 mg
16037950|NCT02610218|Other|CTC and cfDNA analysis|The enumeration of CTCs as well as the detection of HER2 expression will be achieved via the integrated subtraction enrichment (SET) and immunostaining-fluorescence in situ hybridization (iFISH) platform. Further, for the geneomic analysis, the enriched single CTC will be isolated for single-cell targeted sequencing. While for cfDNA analysis, extracted DNA from plasma will be directly subjected to targeted sequencing. Tumor response evaluation will be performed after two cycles of chemotherapy by CT/MRI based on RECIST. Clinical data, including tumor stage, metastastic organ, chemotherapy regimen, objective response, progression free survival, overall survival, etc, will be collected according to study protocol.
16037951|NCT02610205|Other|caring touch|The caring touch was adjusted to suit each participant and lasted for 20-60 minutes, once a week, for a maximum of eight treatment sessions altogether. The tactile massage, a soft tissue massage, without applying direct pressure or stretching to the muscles. The massage can be described as slow, gentle, structured, circulating movements with the palm of the therapist's hand, during which natural oil, or oil with the fragrance of lavender, was applied. The healing touch was based on an established procedure, during which the therapist applied a light pressure to the feet, ankles, knees, hips, stomach, heart area, arms, throat, forehead and scalp. The participant was fully dressed during the healing touch, as the therapist used her/his hand in different positions on the participant's body.
16037952|NCT02610192|Device|nSTRIDE Autologous Protein Solution (APS) Kit|Intra-articular injection of APS
16037953|NCT02610179|Dietary Supplement|Standard Glucola GCT|Participants will be screened with the standard method of consumption of the glucola beverage followed by a 1 hour venous blood draw.
16037954|NCT02610179|Dietary Supplement|Twizzlers challenge|Participants will consume the Twizzlers equivalent (10 strawberry flavored Twizzlers) and have their venous blood glucose checked in 1 hour.
16037955|NCT02610166|Behavioral|Game|"In addition to standard medical care, children in the experimental group will receive the Match-3 game. The game will be designed for short individual gameplay sessions (as little as a few seconds), once to three times a day, over the course of 8 weeks, involving no more than 15 minutes per day in anticipated screen time. There is no way to lose the game. Through a structured series of daily interactions, the player will learn strategies and develop decision-making abilities that will assist with management of their own JIA. The Match 3 concept (similar to the game, Bejeweled) will require the player to successfully match the treatment strategy to the JIA symptom."
16037956|NCT02610166|Other|Usual Care|Children in usual care group receive standard medical care.
16037990|NCT02609919|Drug|Gadoteric Acid|MRI Contrast Agent
16038023|NCT02609724|Other|Traditional MLD|Traditional MLD is applied without knowledge of the patient-specific lymphatic architecture. During MLD no cream or oil is used. A pressure with the hands up to 40 mmHg is applied. Drainage is performed at the level of the jugular and occipital region and the belly (in the depth). Draining techniques are applied on the retroclavicular lymph nodes, axillary lymph nodes, humeral lymph nodes and cubital lymph nodes. At the level of the hand, arm, shoulder and trunk, hand movements are applied to stimulate lymphatic transport through the lymph collectors. The therapist's hands perform 'pumping-movements' while stretching the skin.
16037957|NCT02610153|Drug|Vitamin K Antagonist|The vitamin K antagonists exert their anticoagulant effect through inhibition of the enzyme complex of vitamin K epoxide reductase subunit 1 with subsequent reduction of the gamma-carboxylation of certain glutamic acid molecules endpoints located on factors coagulation II (prothrombin), VII, IX and X and protein C or its cofactor protein S. This gamma-carboxylation has a significant bearing on the interaction of coagulation factors referenced with calcium ions. Without this reaction, blood clotting cannot be initiated. The dose must be adjusted to each patient at baseline and after regular basis, since the sensitivity to anticoagulants varies between individuals and can also vary throughout the treatment. For this, the Prothrombin Time (PT) is used and standardized ratio called International Normalised Ratio (INR).
16037958|NCT02610140|Drug|Anetumab ravtansine (BAY94-9343)|Starting dose: 6.5 mg/kg administered as IV infusion over 1 h every 3 weeks until disease progression or treatment withdrawal for any reason. Dose reductions are permitted.
16037959|NCT02610140|Drug|Vinorelbine|Starting dose: 30mg/m^2 administered as an IV infusion over 6 to 10 min every week until disease progression or treatment withdrawal for any reason. Dose reductions are permitted per standard practise.
16037960|NCT02610127|Biological|OBIZUR|Treating physician will determine treatment regimen, frequency of laboratory and clinical assessments, according to routine clinical practice.
16037961|NCT02610114|Other|Z-Score and computer algorithm|In addition to the routine Z-score for zygote selection, if needed, the photographs of the zygotes already taken for quality and safety reasons are analysed using the new computer algorithm. Within a few minutes it generates a score, determining the quality of the cells. The two best cells upon Z-score result and new computer algorithm result are selected for first transfer.
16037962|NCT02610114|Other|Z-Score|After fertilisation pronuclei and nucleoli can be seen inside the cells by microscope. Routinely, the alignment of nucleoli can be used generating a score, the Z-score 1-4, established by Scott. Two zygotes getting the best Z-score are selected for cell culture and the cells that develop to embryo stage are used for first transfer.
16037963|NCT02610101|Other|Traditional SCD Diet|Traditional SCD includes removal of all processed foods as well as all grains, sweetners except for honey and all diary except for yogurt fermented for over 24hrs and some hard cheeses
16037964|NCT02610101|Other|Modified SCD Diet|Food components of the traditional SCD with the addition of rice and oats.
16037965|NCT02610101|Other|Whole foods diet|A whole foods diet with removal of processed foods. Removal of corn, wheat, sugar and milk are also apart of this dietary regime.
16037966|NCT02610088|Drug|Dapagliflozin|Dapagliflozin 10 mg, orally once daily at any time of day with or without food. If HbA1c does not decrease by > 0.4% at 12 week, rescue therapy (sitagliptin 100 mg) can be added at investigator's discretion.
16037967|NCT02610088|Drug|Gliclazide|Gliclazide MR 30 mg, orally once daily at any time of day with or without food. If HbA1c does not decrease by > 0.4% at 12 week, rescue therapy (gliclazide MR 30 mg) can be added at investigator's discretion.
16037968|NCT02610075|Drug|AZD1775|All patients will receive intervention with AZD1775 orally. Patients will continue to receive treatment with AZD1775 until disease progression, intolerable toxicity, or discontinuation criteria are met.
16037969|NCT02610062|Drug|AGS67E|Intravenous (IV) infusion
16037970|NCT02610049|Behavioral|Cognitive Processing therapy|8 sessions of standard CPT from CPT manual developed by Dr. S Resick, Monson & Chard (11/2010)
16037971|NCT02610049|Behavioral|Art + CPT|8 sessions of individual therapy of mixes techniques Art + CPT 8 sessions of standard CPT (same 8 as in control group) from manual developed by Dr.s Resick, Monson & Chard (11/2010)
16037972|NCT02610049|Behavioral|CPT + Art Therapy|Subjects to complete 8 sessions of standard Cognitive Processing Therapy from manual developed by Dr. S. Resick, Monson & Chard (1/2010) CPT + Art Therapy of mixed individual techniques
16037976|NCT02610010|Drug|Cisplatin|Cisplatin 100 mg/m² every 3 weeks for 3 cycles during radiotherapy.
16037977|NCT02610010|Radiation|Intensity-modulated radiotherapy|Intensity-modulated radiotherapy
16037978|NCT02609997|Procedure|Phacomulsification lens removal cataract surgery with single-piece Intraocular lens(IOL) implantation|The phacoemulsification lens removal cataract surgery is performed with single-piece IOL.During Phacoemulsification.
16037979|NCT02609997|Procedure|Phacomulsification lens removal cataract surgery with three-piece Intraocular lens(IOL) implantation|The phacoemulsification lens removal cataract surgery is performed with three-piece IOL.During Phacoemulsification.
16037980|NCT02609997|Drug|Subconjunctival dexamethasone|All patients received subconjunctival dexamethasone (2 mg) during surgery. Topical anesthesia, consisting of a single drop of 0.5% proparacaine (Alcaine, Alcon Laboratories), was administered three times at intervals of 5 minutes prior to surgery
16037981|NCT02609997|Device|Viscoelastic materials|viscoelastic materials are used to protect corneal endothelial cells
16037982|NCT02609997|Drug|proparacaine|0.5% proparacaine (Alcaine, Alcon Laboratories)
16037983|NCT02609984|Biological|CMB305|A combination of LV305 administered intradermally (ID) and G305 administered intramuscularly (IM)
16037984|NCT02609984|Biological|atezolizumab|IV Infusion
16037985|NCT02609971|Other|Vibration at 50 Hz|During the exercise protocol, the vibration platform will be turned on at a vibration frequency of 50 Hz.
16037986|NCT02609958|Drug|Varlitinib|"varlitinib tablets with:
~starting dose: 300mg BID
~target dose: 400mg BID
~dose modification by investigator allowed between 200mg BID to 500mg BID"
16037987|NCT02609945|Drug|zolmitriptan|Oral Tablet and Nasal Spray
16037988|NCT02609945|Drug|CVT-427 (zolmitriptan inhalation powder),|Capsules containing zolmitriptan; dose levels equivalent to estimated fine particle dose (i.e., lung-delivered) zolmitriptan.
16037989|NCT02609932|Drug|Administration of drug (Interferon-gamma 1-b) subcutaneously|SD = group who has received a single dose of IFN-gamma (10, 25, 50, and 100 mcg/m2) given once with subsequent analysis of effects (serum IL-10, Neuropterin, and IFN levels as well as neutrophil Nox2 activity and gene expression by Affimetrics Chip analysis). One month is allowed between doses. SS = administration of four doses (50 mcg/m2) of IFN-gamma given on Monday, Wednesday Friday schedule with neutrophil or monocyte function studies performed before the first and after the fourth dose to determine steady state effects.
16037991|NCT02609906|Device|PhilosTM with augmentation (Depuy-Synthes)|"All fractures will initially be immobilised by a Gilchrist-bandage. This is the same procedure as for patients who do not attend this or any other trial and will be performed by the doctor on-duty in the emergency room. Patients will be admitted to the trauma ward after that. On the same day or at the latest on day after this patients will be informed about the current investigation, screened, included and randomized by one of the study doctors to our trial after written consent will be obtained as described above.
~Operative treatment is exclusively performed by the below mentioned study doctors. This group will be treated by the angle stable plate fixation system PhilosTM with augmentation (Depuy-Synthes)."
16037992|NCT02609906|Device|MultiLoc®-Nail (Depuy-Synthes)|"All fractures will initially be immobilised by a Gilchrist-bandage. This is the same procedure as for patients who do not attend this or any other trial and will be performed by the doctor on-duty in the emergency room. Patients will be admitted to the trauma ward after that. On the same day or at the latest on day after this patients will be informed about the current investigation, screened, included and randomized by one of the study doctors to our trial after written consent will be obtained as described above.
~Operative treatment is exclusively performed by the below mentioned study doctors. This group will be treated by the multiplanar proximal humeral nail MultiLoc® (Depuy-Synthes)."
16037993|NCT02609893|Other|modified directly observed therapy (mDOT)|
16037994|NCT02609893|Other|unobserved dosing|
16037995|NCT02609893|Other|Motivational Interviewing-based counseling|Motivational Interviewing-based risk reduction and medication adherence counseling
16037996|NCT02609880|Behavioral|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy is used to optimize sleep, pain, and mood in women with gynecologic cancers and will be provided 2 hours once a week for six weeks.
16037997|NCT02609880|Behavioral|Psychoeducation|Psychoeducation is used to provide information, resources, and non-specific support related to adapting well to cancer. Sessions will be provided 2 hours once a week for 6 weeks.
16037998|NCT02609867|Device|Flowise Cerebral Flow Diverter|Flowise Cerebral Flow Diverter Placement
16037999|NCT02609854|Device|Sustained Acoustic Medicine (SAM)|Long-duration, low-intensity therapeutic ultrasound device that is self-applied and wearable, delivering treatment up to 4 hours per day.
16038000|NCT02609854|Device|Sham Device|Inactive ultrasound device
16038001|NCT02609841|Device|Cardiac rhythm remote monitoring system|Non-invasive wearable remote cardiac rhythm monitoring system used throughout 12 days of study.
16038003|NCT02609815|Drug|gemigliptin/metformin|zemimet-SR 50/1000 mg x 1 tablet
16038004|NCT02609815|Drug|glimepiride/metformin|amaryl-Mex 1/500 mg x 2 tablets
16038005|NCT02609802|Drug|Sevoflurane|Anesthesia was maintained with sevoflurane in patients undergoing arthroscopic shoulder surgery under general anesthesia and interscalene brachial plexus block.
16038006|NCT02609802|Drug|Desflurane|Anesthesia was maintained with desflurane in patients undergoing arthroscopic shoulder surgery under general anesthesia and interscalene brachial plexus block.
16038007|NCT02609789|Drug|JNJ-55920839|JNJ-55920839 will be administered as either IV infusion or subcutaneous injection.
16038008|NCT02609789|Drug|Placebo|0.9 percent (%) normal saline.
16038009|NCT02609776|Drug|Amivantamab|The first cohort of participants will receive IV infusions of Amivantamab 140 mg as monotherapy. Each subsequent cohort will receive IV infusions of Amivantamab at increased dose level until maximum tolerated dose is reached or all planned doses are administered. Participants will receive lazertinib and Amivantamab at predefined dose levels, based upon observed safety and protocol defined criteria. The duration of each treatment cycle is 28 days. In Chemotherapy Combination Cohort, participants will receive Amivantamab, administered on a 21-day cycle, in combination with the administration of standard of care carboplatin and pemetrexed.
16038010|NCT02609776|Drug|Amivantamab|Participants will receive IV infusion of Amivantamab as monotherapy at RP2D regimen or in combination lazertinib at RP2CD regimen as determined in Part 1.
16038011|NCT02609776|Drug|Lazertinib|Lazertinib will be administered in combination with Amivantamab at predefined dose levels, based upon observed safety and protocol defined criteria. Lazertinib will be administered daily on the 28-day Amivantamab treatment cycle.
16038012|NCT02609776|Drug|Carboplatin|Participants will receive carboplatin in combination with pemetrexed and Amivantamab as an IV infusion on 21-day treatment cycle in Part 1 Chemotherapy Combination Cohort only.
16038013|NCT02609776|Drug|Pemetrexed|Participants will receive pemetrexed in combination with carboplatin and Amivantamab as an IV infusion on 21-day treatment cycle in Part 1 Chemotherapy Combination Cohort only.
16038014|NCT02609750|Other|Structured care & workplace intervention|In addition to structured care a workplace intervention named Convergence Dialogue Meetings (CDM) are carried out. CDM is a three step structured dialogue and meeting model supporting the patient, health care professionals and employer to summarize concrete suggestions to support sustainable work ability and a return to work if sick listed.
16038015|NCT02609750|Other|Treatment as Usual|Patients will follow the primary health care's standard time schedule and procedures as of ordinary care and the rehabilitation guarantee. For each patient all treatment measures are recorded in a manual, regarding number of treatments, time used per treatment and type of treatment.
16038016|NCT02609737|Device|PET/CT Imaging|
16038017|NCT02609737|Radiation|68Ga-DOTA-JR11|
16038018|NCT02609737|Radiation|177Lu-DOTA-JR11|
16038019|NCT02609724|Other|Information|During intensive phase: a leaflet with information about the lymphatic system and lymphoedema, clinical evaluation and conservative treatment of lymphoedema During maintenance phase: two informational sessions about self-management and about compression sleeves and other compression material
16038020|NCT02609724|Other|Skin care|The skin is hydrated during the session. If wounds are present, the wound is cared.
16038021|NCT02609724|Other|Compression therapy|During intensive phase: application of multi-layer, multi-component bandages During maintenance phase: wearing custom-made compression garment
16038022|NCT02609724|Other|Fluoroscopy-guided MLD|Fluoroscopy-guided MLD is applied on patient-specific lymphatic system (known from lymphofluoroscopy) by applying cleaning techniques on lymph nodes, resorption techniques to stimulate resorption of lymph by lymph capillaries and gliding technique to stimulate transport of lymph through lymph collectors
16043213|NCT02573727|Drug|Terlipressin + albumin|
16038024|NCT02609724|Other|Placebo MLD|During placebo MLD a superficial massage with massage cream is performed on the patient's contralateral arm and on the belly.
16038025|NCT02609711|Drug|Candesartan cilexetil|
16038026|NCT02609698|Device|Coroflex ISAR|This stent platform has a thin-strut cobalt-chromiun alloy backbone, no polymer, microporous surface.
16038027|NCT02609698|Drug|3 months DAPT|
16038028|NCT02609698|Drug|6 months DAPT|
16038029|NCT02609685|Other|Active Surveillance|Subjects will be actively observed for disease progression (condition worsens) instead of receiving immediate surgery, considered standard of care.
16038030|NCT02609672|Other|Exercise|A biomechanical exercise program shown to decrease joint loading was administered 3 times a week for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
16038031|NCT02609672|Other|No Exercise|A no exercise (control) group maintained their existing activity level for 12 weeks. Outcomes included mobility performance; pain; strength; cardiovascular fitness; and resilience.
16038032|NCT02609659|Drug|ombitasvir/paritaprevir/ritonavir and dasabuvir|Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet
16038033|NCT02609659|Drug|ribavirin|Tablet
16038034|NCT02609646|Drug|Linezolid|Drug choice is performed according to standard clinical practice, that will not be modified by the participation in the study. As a consequence, assignment of patients to groups is not protocol based, but it is defined by standard clinical choices.
16038035|NCT02609646|Drug|Meropenem|Drug choice is performed according to standard clinical practice, that will not be modified by the participation in the study. As a consequence, assignment of patients to groups is not protocol based, but it is defined by standard clinical choices.
16038036|NCT02609646|Drug|Piperacillin-tazobactam combination product|Drug choice is performed according to standard clinical practice, that will not be modified by the participation in the study. As a consequence, assignment of patients to groups is not protocol based, but it is defined by standard clinical choices.
16038037|NCT02609646|Drug|Vancomycin|Drug choice is performed according to standard clinical practice, that will not be modified by the participation in the study. As a consequence, assignment of patients to groups is not protocol based, but it is defined by standard clinical choices.
16038038|NCT02609633|Device|Accu-Chek® CONNECT DMS|SMBG will be performed during the 6-month study using the Accu-Chek® Aviva CONNECT monitoring device, and corresponding Smartphone app and online tracking tool.
16038039|NCT02609633|Device|DMS|SMBG will be performed during the 6-month study according to usual care, using the participant's current DMS (other than Accu-Chek® CONNECT DMS).
16038040|NCT02609620|Device|Peristaltic Feeding Tube|
16038041|NCT02609620|Device|ConvaTec Levin Duodenal Tube|
16038042|NCT02609607|Drug|Bisacodyl|Rectal suppository
16038043|NCT02609607|Other|Placebo|Rectal suppository
16038044|NCT02609594|Other|Weekly application of Amnioband|Weekly application of Amnioband.
16038045|NCT02609594|Other|Biweekly application of Amnioband|Biweekly application (every two weeks) of Amnioband.
16038046|NCT02609594|Other|Standard of Care|Standard of care for this study is weekly multi-layer compression bandaging.
16038047|NCT02609581|Drug|Sublingual Immunotherapy with tablets (mites)|Sublingual immunotherapy involves putting a tablet of allergen extracts (mites) under the tongue to swallow the extract.
16038048|NCT02609555|Procedure|TEM perineal rectopexy|perineal rectopexy using polyprolene mesh assisted by TEM technique and special proctoscope postanal repair in two layers to narrow the postanal space anal cerclage with absorbable sutures
16038049|NCT02609542|Other|Eye Tracking|Eye tracker will allows the recording of various information concerning eye fixation (number, duration, location) and saccadic eye movement (speed, range, number, duration) in order to determine the interplay between linguistic and visual information processing during tests performance
16038050|NCT02609529|Other|Medical Food|Serum-derived bovine immunoglobulin protein isolate will be supplied by EnteraHealth. The product is manufactured in accordance with Good Manufacturing Practice (GMP) and U.S. Food and Drug Administration (FDA) guidelines for medical food ingredients (21 CFR Part 110). Serum-derived bovine immunoglobulin protein isolate (SBI) is generally recognized as safe (GRAS). The FDA has reviewed the safety dossier for SBI as a medical food product.
16038051|NCT02609529|Other|Placebo|
16038052|NCT02609516|Other|This is not an intervention study|This study is based on the retrospective analysis of linked electronic health records.
16038053|NCT02609503|Drug|Pembrolizumab|Pembrolizumab, 200 mg IV during cycle visits every 3-weeks for up to 6 cycles, or until toxicities are no longer tolerable
16038054|NCT02609503|Radiation|Intensity Modulated Radiation Therapy|Eligible participants will receive Intensity Modulated Radiation Therapy daily x 7 weeks
16038055|NCT02609490|Drug|Azilsartan tablets|20mg/tablet
16038056|NCT02609490|Drug|Azilsartan placebo tablets|placebo tablet
16038057|NCT02609490|Drug|Olmesartan medoxomil tablets|20mg/tablet
16038058|NCT02609490|Drug|olmesartan medoxomil placebo tablets|placebo tablet
16038059|NCT02609477|Drug|Istradefylline|Istradefylline 40, 80, 160 mg
16038060|NCT02609477|Drug|Phentermine 45 mg|Phentermine 45 or 90 mg
16038061|NCT02609477|Other|Placebo|Placebo
16038062|NCT02609464|Device|Interrupted Knotted Sutures|
16038063|NCT02609464|Device|STRATAFIX Symmetric PDS PLUS Knotless Tissue Control Devices|
16038064|NCT02609451|Procedure|Ileostomy closure|Ileostomy closure at a different time point
16038065|NCT02609438|Behavioral|Short breaks|Following baseline testing, participants will attend a 30-minute individual orientation session, during which they will complete a planning worksheet with a research assistant. They will identify specific strategies they will use to accomplish the pre-specified goal (i.e., to take a 1-minute active break every 30 minutes during the workday). They will also identify potential barriers they will face and devise strategies for overcoming them. The intervention will officially start the Monday after the orientation session and will last for 8 weeks. Participants will receive a weekly email containing tips related to reducing sitting time at work. All participants will complete daily activity logs indicating the time and duration of all breaks from sitting across the 8-week intervention.
16038139|NCT02608996|Drug|Nesiritide|This intervention is designed to determine the optimal dose range of BNP for treatment of patients with uncontrolled hypertension
16038140|NCT02608996|Drug|Placebo|For comparison to elucidate the true effect of nesiritide
16038066|NCT02609438|Behavioral|Long breaks|Following baseline testing, participants will attend a 30-minute individual orientation session, during which they will complete a planning worksheet with a research assistant. They will identify specific strategies they will use to accomplish the pre-specified goal (i.e., to take two 15-minute activity breaks during each workday). They will also identify potential barriers they will face and devise strategies for overcoming them. The intervention will officially start the Monday after the orientation session and will last for 8 weeks. Participants will receive a weekly email containing tips related to reducing sitting time at work. All participants will complete daily activity logs indicating the time and duration of all breaks from sitting across the 8-week intervention.
16038067|NCT02609425|Device|Stratafix PGA Suture|Subject leak Stricture rates post procedure
16038068|NCT02609412|Other|Static compression of LMTRP|Static compression of most sensitive Triggerpoint with a foam roller (Blackroll Inc., Germany).
16038069|NCT02609412|Other|Dynamic self-myofascial release of calf|Dynamic self-massage of the calf with a foam roller (Blackroll Inc., Germany).
16038070|NCT02609412|Device|Placebo laser acupuncture of LMTRP|Used device: Laserneedle System (Laserneedle Systems GmbH, Glienicke/Nordbahn, Germany). Electrodes positioned on skin but device remains switched off.
16038071|NCT02609399|Drug|Oseltamivir|Oral
16038072|NCT02609399|Drug|Peramivir|"IV
~Note: Subjects admitted to the hospital directly from the ED Enrollment Visit may receive more doses at the discretion of the treating physician."
16038073|NCT02609386|Biological|IRX-2|Method of Administration: Administered for 10 days as subcutaneous bilateral injections in the upper neck.
16038074|NCT02609386|Drug|Cyclophosphamide|Method of Administration: Cyclophosphamide is administered once by IV
16038075|NCT02609386|Drug|Indomethacin|Method of Administration: Indomethacin is administered orally for 21 days.
16038076|NCT02609386|Dietary Supplement|Zinc-containing multivitamin|Method of Administration: Zinc-containing multivitamin is administered orally for 21 days.
16038077|NCT02609386|Drug|Omeprazole|Method of Administration: Omeprazole is administered orally for 21 days
16038078|NCT02609373|Behavioral|Sleep intervention|"Session 1: Intervener & participant review 2-week sleep diary and actigraph data. Provide individualized sleep hygiene prescription.
~Session 2: Review sleep diary; calculate sleep efficiency; identify adjustments needed.
~Session 3: Review sleep-related vs. stress-related symptoms. Develop plan for sleep-related symptoms and discuss Sleep Restriction with Relaxation Exercises. Session 4: Reinforce progress and make corrections as required. If Sleep Restriction is not working, Stimulus Control is introduced.
~Session 5-10: Provide reinforcement, assess adherence, answer questions, and offer encouragement and monitoring, including alterations as required.
~Booster sessions: At 8 & 10 months: reinforcement, question answering, encouragement and monitoring."
16038079|NCT02609360|Other|Priming of ECMO circuit with 0.9% NaCl|0.9% NaCl as priming crystalloid solution
16038080|NCT02609360|Other|Priming of ECMO circuit with Ringer Lactate|Ringer Lactate as priming crystalloid solution
16038081|NCT02609360|Other|Priming of ECMO circuit with Balanced Solution|Balanced Solution as priming crystalloid solution
16038082|NCT02609347|Other|Manual Therapy Group|The manual therapy intervention will be based on the typed of fracture the patient sustained, and their limitations in joint mobility.
16038083|NCT02609347|Other|Control Group|The sham intervention will consist of soft tissue mobilization and Grade I mobilization at the proximal tib/fib joint.
16038084|NCT02609334|Drug|CRD007|One single dose given 3 hours prior to Mannitol challenge
16038085|NCT02609334|Other|Placebo|One single dose given 3 hours prior to Mannitol challenge
16038086|NCT02609321|Procedure|Thoracic Paravertebral Block|Thoracic paravertebral block at T3 level with bupivacaine 0.5%, dosis 1.5mg/Kg
16038087|NCT02609321|Procedure|Surgical Wound Infiltration|Surgical wound infiltration on the skin and subcutaneous tissue in surgical area with bipivacaine 0.5%, dosis 1.5mg/kg
16038088|NCT02609308|Other|Short leg cast|Immobilization with short leg cast with a dorsiflexed foot for two weeks
16038089|NCT02609308|Procedure|Platelet-rich plasma|Will be applied 5 mL of autologous platelet-rich plasma under the lateral malleolus, over the anterior talofibular ligament
16038090|NCT02609295|Dietary Supplement|Placebo|1.2 g (two capsules) of medium-chain triglyceride (MCT) oil
16038091|NCT02609295|Dietary Supplement|ALA group|1.2 g (two capsules) of perilla oil
16038092|NCT02609282|Behavioral|Hourly prompts to stand delivered by Microsoft Outlook|
16038093|NCT02609269|Other|Decipher Prostate Cancer Classifier|The Decipher Prostate Cancer Classifier (Decipher Test) is a genomic test that predicts the probability of high-grade disease, metastasis and prostate cancer specific mortality for men with prostate cancer and is commercially available through GenomeDx Biosciences' CLIA & CAP certified laboratory in San Diego, CA
16038094|NCT02609269|Other|Decipher Genomics Resource Information Database (GRID)|The Decipher GRID (GRID) is the world's largest research use only (RUO), clinically annotated urologic cancer genomic expression database, built up over 8 years of US and international research conducted using the Decipher® (Decipher) test platform. The GRID currently consists of genomic data comprised of 1.4M data points per patient from more than 20,000 prostate and bladder cancer patients, including those from published retrospective clinical studies that have been annotated with comprehensive treatment and outcomes data. It is anticipated that the GRID will also contain data from several other types of cancer in the future.
16038095|NCT02609256|Procedure|Stereotactic infarct tissue aspiration|The patient posed supine position to expose local skin and puncture point was located at 6.5 cm behind the hairline of the lesion side, and 5.0 cm lateral of midline. After routine skin preparation and disinfection, 5% lidocaine 2-5 ml was injected for local anesthesia. The skin was cut to expose periosteum by a scalpel. After skull was vertically drilled through with a 6mm diameter hole, a sterile tube with a needle in tube was put about 8 cm into centrum semiovale. The needle was put out and about 50ml necrosis brain tissue was aspirated by a 20 ml syringe. The tube was fixed into the skin about 2 cm after subcutaneous tunnel, and connected to the drainage bag. Surgical area was sterilized and wrapped by sterile gauze bandage.
16038096|NCT02609256|Other|Medical therapy|osmotic therapy with mannitol and glycerol fructose，anti-platelet treatment, statins, and other symptomatic treatments such as controlling blood pressure, blood sugar, and infection, and tracheal intubation or incision, etc
16038141|NCT02608983|Dietary Supplement|Agar H1CC2013|Following a 28-day washout one 250ml drink / day containing 8g of agar H1CC2013 as part of normal diet for 28 days
16038097|NCT02609243|Behavioral|dietary consulting|dietary consulting implies specific dietary advice based on pre-interventional self-report regarding food intake; consulting focuses on nutrient content, calory intake, weight loss; with regard to randomisation consulting intensity and content varies
16038098|NCT02609230|Drug|ONC-201|
16038099|NCT02609217|Other|Questionnaires and interviews|
16038100|NCT02609204|Diagnostic Test|Diopsys NOVA|Healthy Controls will have both eyes tested by the Diopsys NOVA machine using Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG) modules.
16038101|NCT02609191|Device|"Whole body exam using the Discovery A"|"Whole body exam using the Discovery A machine made by Hologic."
16038102|NCT02609191|Device|"First whole body exam using the Stratos DR"|"First whole body exam using the Stratos DR machine made by the DMS group."
16038103|NCT02609191|Device|"Second whole body exam using the Stratos DR"|"Second whole body exam using the Stratos DR machine made by the DMS group. This second exam is required for reproducibility purposes."
16038104|NCT02609178|Procedure|FGP|To execute FGP technique, the occlusal surface of the interim should be back cut to leave at least 1mm occlusal space. Then apply the recording resin. Ask the subjects to close the mouth to maximum intercuspal position then perform right lateral, left lateral and protrusive movements in succession ending in maximum intercuspation position. Excessive resin then should be trimmed off and Bausch articulating paper would be used to mark the intercuspal contacts. Zinc oxide is then applied to check eccentric occlusion, trimmed off resin if there're interferences. Then the interim would be used as a copy to design the occlusal surface of the crown. (CAD/CAM)
16038105|NCT02609178|Procedure|AVR|the crowns in this group would be designed by setting virtual articulator to average mode (CAD/CAM)
16038106|NCT02609165|Drug|rhNGF 180 µg/ml eye drops solution|eye drops
16038107|NCT02609165|Drug|vehicle eye drops|placebo
16038108|NCT02609152|Drug|Continuous perfusion of esmolol|In the experimental arm of the study, a continuous perfusion of esmolol will be performed. This infusion starts at 5 ml / h with an increase of 5 ml / hr every 10 minutes to obtain a 15% decrease in heart rate. The infusion will be reduced by 5 ml / h every 5 minutes if the cardiac rate is less than 90 beats per minute and stopped if it is less than 70 beats per minute. At H4, the doctor in charge is free to gradually continue or stop the infusion.
16038109|NCT02609152|Drug|Continuous perfusion of saline|In the control arm of the study, a continuous infusion of normal saline will be performed. This infusion starts at 5 ml / h with an increase of 5 ml / hr every 10 minutes to obtain a 15% decrease in heart rate. The infusion will be reduced by 5 ml / h every 5 minutes if the cardiac rate is less than 90 beats per minute and stopped if it is less than 70 beats per minute. A H4, the doctor in charge is free to gradually continue or stop the infusion.
16038110|NCT02609139|Drug|PF-06650833|Up to 400mg modified release tablets administered under fasted conditions
16038111|NCT02609139|Drug|PF-06650833|100mg modified release tablet administered under fasted conditions
16038112|NCT02609139|Drug|PF-06650833|20mg modified release tablet administered under fasted conditions
16038113|NCT02609139|Drug|PF-06650833|Up to 400mg modified release tablets administered with high fat meal food intake
16038114|NCT02609139|Drug|PF-06650833|100mg modified released tablet administered with high fat meal food intake
16038115|NCT02609139|Drug|PF-06650833|20 mg modified release tablet administered with high fat meal food intake
16038116|NCT02609126|Drug|EP-104IAR|Single, ultrasound-guided injection of EP-104IAR into the knee
16038117|NCT02609126|Drug|Vehicle|Single, ultrasound-guided injection of vehicle placebo into the knee
16038118|NCT02609113|Device|Strong Magnetic Wristband|
16038119|NCT02609113|Device|Weaker Magnetic Wristband|
16038120|NCT02609100|Procedure|Video Capsule Endoscopy|Video Capsule Endoscopy allows for imaging of the small intestine between the distant duodeno-jejunal junction, which is beyond the reach of upper GI endoscopy and the terminal ileum and is similarly beyond the reach of colonoscopy. It is of greatest use in identifying points of bleeding and ulcers.
16038121|NCT02609100|Procedure|Colonoscopy|The colonoscopy helps find ulcers, tumors, and areas of inflammation or bleeding in the large intestine.
16038122|NCT02609100|Device|1.0 X 2.5 cm 'pill' containing a camera|
16038123|NCT02609087|Drug|Sevoflurane|
16038124|NCT02609087|Drug|Propofol|
16038125|NCT02609074|Procedure|Minimally invasive internal fixation surgeries|
16038126|NCT02609074|Device|CPC/rhBMP-2 micro-scaffolds|
16038127|NCT02609074|Device|CPC paste|
16038128|NCT02609061|Procedure|Open flap debridement (OFD)|Open flap debridement (OFD) alone
16038129|NCT02609061|Procedure|OFD with Platelet rich fibrin (PRF)|Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement
16038130|NCT02609061|Procedure|OFD with Platelet rich fibrin (PRF)+1% Alendronate (Drug) in gel form|Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Alendronate gel placement
16038131|NCT02609048|Drug|Placebo Comparator|Placebo Capsule (2 taken once daily)
16038132|NCT02609048|Drug|Experimental: Seladelpar / MBX-8025 50 mg|MBX-8025 50 mg capsule (1 taken once daily)
16038133|NCT02609048|Drug|Experimental: Seladelpar / MBX-8025 200 mg|MBX-8025 100 mg capsules (2 taken once daily)
16038134|NCT02609035|Behavioral|Telephonic prompt|
16038135|NCT02609022|Biological|CV-MG01|"3 consecutive subcutaneous injections of CV-MG01. The three injections are planned for each patient on Days 1, 29 (+/- 3 days) and 85 (+/- 7 days), respectively.
~Two dose levels: low and high dose."
16038136|NCT02609022|Biological|Placebo|3 consecutive subcutaneous injections of placebo. The three injections are planned for each patient on Days 1, 29 (+/- 3 days) and 85 (+/- 7 days), respectively.
16038137|NCT02609009|Other|Spinal Manipulation Therapy|Intervention will consist of Diversified type adjustments. Patients will be assigned to the nearest participating chiropractic clinic and will have a complete standardized examination on their first visit. Patient will then receive a maximum of 12 treatments (3x per week for a period of 4 weeks).
16038138|NCT02609009|Other|Usual Medical Care|Usual interventions generally consist in the administration of medications (NSAIDs or ibuprofen), physical therapy or exercises. If recommended, physical therapy will be provided by the hospital physical therapy services. Physical therapy might include treatments such as massage, different electrotherapy, postural repositioning, exercises, etc
16040189|NCT02594761|Biological|Herceptin US|Intravenous Infusion, 440 mg/vial
16038142|NCT02608983|Dietary Supplement|Agar H1CC2012|Following a 28-day washout one 250ml drink / day containing 8g of agar H1CC2012 as part of normal diet for 28 days
16038143|NCT02608983|Dietary Supplement|Maltodextrin|Following a 28-day washout one 250ml drink / day containing 8g of maltodextrin as part of normal diet for 28 days
16038144|NCT02608970|Drug|BMS-986177|
16038145|NCT02608970|Other|Placebo|
16038146|NCT02608957|Device|Latella Knee Implant System|
16038147|NCT02608944|Drug|Adenosine|Adenosine: 0.14mg/kg/min for 6 min. IV injection for MRI perfusion
16038148|NCT02608944|Drug|Regadenoson|Regadenoson: 0.4mg in 5ml, given as a rapid (10 seconds) IV injection for MRI perfusion.
16038149|NCT02608944|Drug|O-15 labeled radioactive water|O-15 labeled radioactive water: Up to 50mCi IV injection at rest and again at hyperemia for PET Imaging
16038150|NCT02608944|Device|MRI|Pass dynamic contrast enhanced MRI scans will be performed at rest and during hyperemia caused by either adenosine infusion or regadenoson
16038151|NCT02608944|Device|PET Imaging|Quantitative PET imaging with O-15 labeled radioactive water will be given at a different day.
16038152|NCT02608931|Drug|Dronabinol|
16038153|NCT02608931|Other|Placebo|placebo
16038154|NCT02608918|Drug|BMS-955176|
16038155|NCT02608905|Drug|Dapagliflozin|Patients with Type 2 diabetes will be randomized to receive dapagliflozin 5 mg daily for 2 weeks followed by10 mg daily for 10 weeks by mouth or matching placebo for 12 weeks. All subjects will receive measurements of fasting plasma glucose, Free Fatty Acids, inflammatory markers and adipocytokines, monocyte inflammation, as well as ultrasound assessment of flow-mediated dilatation (FMD) of the brachial artery at baseline and after 12 weeks of drug treatment with either dapagliflozin or placebo.
16038156|NCT02608905|Drug|Placebo|Patients with Type 2 diabetes will be randomized to receive dapagliflozin 5 mg daily for 2 weeks followed by10 mg daily for 10 weeks by mouth or matching placebo for 12 weeks. All subjects will receive measurements of fasting plasma glucose, Free Fatty Acids, inflammatory markers and adipocytokines, monocyte inflammation, as well as ultrasound assessment of flow-mediated dilatation (FMD) of the brachial artery at baseline and after 12 weeks of drug treatment with either dapagliflozin or placebo.
16038157|NCT02608892|Behavioral|BSweet2Babies video|Mothers (and partners if possible) will view the brief BSweet2Babies video on electronic notebooks in French or English, as per parent/s' preference.
16038158|NCT02608879|Procedure|Oral Mucosa Deterging and Periodontal Debridement (OMDP)|OMDP consists of a regimen of frequent professional oral prophylaxis including tooth cleaning, tooth polishing and flossing, and the cleaning of the periodontum and oral mucosa. This is an intervention that is implemented prior to and maintained throughout the entire cycle of the radiation or chemoradiation.
16038159|NCT02608879|Procedure|Standard of Care Oral Hygiene Instructions|Subjects assigned to this intervention will receive standard of care oral hygiene instructions, including in-person instruction and materials to reference at home. Subjects will also have their teeth brushed and flossed bi-weekly by a dental professional.
16038160|NCT02608879|Procedure|Dental scaling, ultrasonic|An ultrasonic dental scaler will be used to clean the teeth
16038161|NCT02608879|Other|Chlorhexidine|Non-alcoholic chlorhexidine will be used as part of the OMDP protocol
16038162|NCT02608866|Radiation|SF-SSRS|Spine stereotactic radiosurgery/ablative radiotherapy (SSRS) with 16 Gy in single fraction to the defined target volume using intensity modulated radiotherapy or volumetric modulated arc therapy (VMAT or RapidArc).
16038163|NCT02608866|Radiation|MF-SSRS|SSRS with 24 Gy in three fractions to the defined target volume using intensity modulated radiotherapy or volumetric modulated arc therapy (VMAT or RapidArc). Treatment should be given on every other day. Treatment on the consecutive days to the same target volume is not allowed.
16038164|NCT02608853|Other|No treatment given|No treatment is actively administered. Patients are treated according to routine clinical practice at the discretion of their treating physicians.
16038165|NCT02608840|Other|Auditory stimulation during sleep|The intervention is a brain computer interface program which measures brain electroencephalogram to identify slow waves and time the sounds. Barely audible sounds are delivered through headphones and played during sleep (specifically, during slow wave sleep).
16038166|NCT02608840|Other|Sham Intervention|The brain electroencephalogram is measured and headphones are worn, but sounds are not played during sleep.
16038167|NCT02608827|Device|Resperate®-InterCure Ltda|The device-guided breathing - Resperate®-InterCure Ltda, uses sound to guide and therefore reduce the respiration rate in individuals.
16038168|NCT02608827|Other|Music group (GC)|The patients in this arm will hear slow music - Music group (GC).
16038169|NCT02608814|Procedure|Pleural biopsy sampling|6 - 8 pleural biopsy samples will be taken before the insertion of the chest drain. These samples will be sent to microbiology for examination.
16038170|NCT02608814|Other|Ultrasound|
16038171|NCT02608788|Drug|S.L.®|"1.5mg/ml Benzydamine hydrochloride, S.L.® spray by mouth . Before intubation, each endotracheal tube cuff was scattered 10 times of spray by physicians that might cover 20 cm long of the cuff."
16038172|NCT02608788|Drug|Difflam Forte ®|"3.0mg/ml Benzydamine hydrochloride ,  Difflam Forte ® spray by mouth . Before intubation, each endotracheal tube cuff was scattered 10 times of spray by physicians that might cover 20 cm long of the cuff."
16038173|NCT02608788|Drug|Acular®|"5％ Ketorolac Tromethamine ,  Acular®  spray by mouth . Before intubation, each endotracheal tube cuff was scattered 10 times of spray by physicians that might cover 20 cm long of the cuff."
16038174|NCT02608788|Drug|placebo|Distilled water spray by mouth. Before intubation, each endotracheal tube cuff was scattered 10 times of spray by physicians that might cover 20 cm long of the cuff.
16038175|NCT02608775|Device|Metrodoloris Medical System|Application of a skin electrode
16038176|NCT02608775|Device|Aisys® care station, Acertys|Standard photoplethysmography
16038177|NCT02608762|Radiation|standard adjuvant local radiation therapy or cranial radiation therapy|
16038215|NCT02608463|Behavioral|painDETECT Questionnaire|This self-report questionnaire consists of 7 questions that address the quality of neuropathic pain syndromes. The first 5 questions ask about the gradation of pain, question 6 asks about the pain course pattern and question 7 asks about radiating pain. There are 4 additional questions (not counted in the total score) which asks the subject to rate their pain now and over the last 4 weeks and to mark on a body chart if there is pain radiating into other parts of the body.
16038178|NCT02608749|Behavioral|Integrated care (IC)|Integraded care (IC) Weekly professional led exercise program for 90 mins with reinforcemen on osteoporosis related educations and caremangements from study educational booklet and CD rom for 3-month. The exercise program included 15 minutes warm up with 10 minute brisk walks followed by gentle stretching. Resistance training (20-30 minutes) was provided with rubber band and bottled water (0.6-1L) as weight for major muscles of upper and lower limbs. Balance training were also provided for 10 minutes with tandem gaits and one leg standing, step up and down stairs, toe walking and heel walking.
16038179|NCT02608749|Behavioral|Lower extremity exercise (LEE)|Lower extremity exercise (LEE) group subjects were invited to BB site to receive 2 sessions of 45-mintute training using isotonic strength training machines on major muslce groups each week. The intensity is set at 60-80% of 1 repetition maximum (RM). Evaluation of the exercise protocol are repeated every 2 weeks for individualized adjustments by trained physical therapist.
16038180|NCT02608749|Behavioral|Home care (HC)|Home care (HC) group subjects were invited to LK site. For examining whether the exercise video could help elderly people to maintain their exercise and improve their muscle strength or not, the investigators provided exercise video to subjects, and encouraged them to play this exercise at least 2 hours for one week.
16038181|NCT02608736|Drug|Valproic Acid|Half of the participants will receive valproic acid orally for three months. Saliva and blood will be sampled in the study entry. The participants will be followed with blood tests every month for three cycles. After the third cycle, saliva and blood will be sampled once more. Finally, histone acetylation and DNMT expression will be studied comparing the samples collected in different timelines and comparing them to saliva collected in placebo arm.
16038182|NCT02608736|Drug|Placebo|The other half of the participants will receive placebo for three months. Saliva and blood will be sampled in the study entry. The participants will be followed with blood tests every month for three cycles. After the third cycle, saliva and blood will be sampled once more. Finally, histone acetylation and DNMT expression will be studied comparing the samples collected in different timelines and comparing them to saliva collected in valproic acid arm.
16038183|NCT02608723|Device|Standard shock waves device|3 sessions were applied: one per week. Energy flux density 0,18 mJ/mm2. Frequency: 8 Hz. 2500 shockwaves/session. The shock waves emitted to the 3 devices are identical; the only difference is the external image of the device.
16038184|NCT02608723|Device|Austere shock waves device|3 sessions were applied: one per week. Energy flux density 0,18 mJ/mm2. Frequency: 8 Hz. 2500 shockwaves/session. The shock waves emitted to the 3 devices are identical; the only difference is the external image of the device.
16038185|NCT02608723|Device|Sophisticated shock waves device|3 sessions were applied: one per week. Energy flux density 0,18 mJ/mm2. Frequency: 8 Hz. 2500 shockwaves/session. The shock waves emitted to the 3 devices are identical; the only difference is the external image of the device.
16038186|NCT02608710|Drug|RDEA3170 4.5 mg|
16038187|NCT02608710|Drug|RDEA3170 6 mg|
16038188|NCT02608710|Drug|RDEA3170 12 mg|
16038189|NCT02608697|Drug|CAT-2054|
16038190|NCT02608697|Drug|Placebo|
16038191|NCT02608697|Drug|Atorvastatin|
16038195|NCT02608671|Procedure|Skin adhesive tape|
16038196|NCT02608658|Other|Medical food, EnteraGam (Serum-Derived Bovine Immunoglobulin)|"Visit 1, screening (Day 0): At this visit, the investigators of the study will:
~Obtain demographic information, as will past medical history and medications.
~Perform a physical examination.
~Collect samples for labs
~Administer the Chronic Liver Disease Questionnaire (CLDQ)
~Perform a lactulose breath test
~From Day 0 to 8 weeks: subjects will take the medical food twice daily
~Visit 2, Week 4 (Day 28 +/- 3): At this visit, the investigators of the study will:
~Perform a physical examination
~Collect and record returned investigational product
~Dispense investigational product and instruct again regarding use
~Record any adverse events
~Visit 3, Week 8 (Day 56 +/- 3): At this visit, the investigators of the study will:
~Perform a physical examination.
~Collect samples for labs
~Administer the Chronic Liver Disease Questionnaire (CLDQ)
~Perform a lactulose breath test"
16038197|NCT02608632|Device|Renal denervation guided by HFS|
16038198|NCT02608632|Device|Renal denervation as standard procedure|
16038199|NCT02608619|Radiation|F-choline PET Scan|
16038200|NCT02608619|Device|FDG-PET|
16038201|NCT02608619|Procedure|biopsy|
16038202|NCT02608606|Drug|Tacrolimus|compared oral administration versus sublingual administration of tacrolimus.
16038203|NCT02608593|Procedure|Strattice|Implant based reconstruction with strattice cover of part or all of implant
16038204|NCT02608580|Other|Survey|
16038205|NCT02608554|Behavioral|Taichi|The program of Taichi training consisted of 60 minutes exercise sessions, 3 days per week for 12 weeks, based on their original level of physical activity. Each session comprised 40 minutes of Taichi training plus a 10-minute warm-up and cool-down. The Taichi training was instructed by the same experienced Taichi instructors who were qualified in the teaching of Taichi. The 24 forms of simplified Taichi recommended as the popular health sport by the General Administration of Sport of China were applied.
16038206|NCT02608554|Behavioral|Self-monitored exercise|Exercise was self-monitored and consisted of brisk walking, cycling, jogging, or any other aerobic exercise for 60 mins. 3 days per week for 12 weeks.
16038207|NCT02608541|Other|rib fracture fixation|Use of MatrixRib, where indicated, according to departmental protocol
16038208|NCT02608528|Radiation|[18F]fluoroglucose(FDG)|
16038209|NCT02608502|Biological|RSV-F Vaccine|
16038210|NCT02608502|Biological|Phosphate Buffer Placebo|
16038211|NCT02608489|Drug|Diquafosol (Diquas)|Diquafosol group used diquafosol 6 times a day during study period.
16038212|NCT02608489|Drug|Sodium Hyaluronate (Hyalein)|Hyaluronate group used sodium hyaluronate 6 times a day during study period.
16038213|NCT02608476|Drug|CB-03-01 cream, 1%|CB-03-01 (cortexolone 17α-propionate) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.
16038214|NCT02608476|Drug|Vehicle cream|Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.
16038281|NCT02608034|Drug|Rifampin|Rifampin will be administered as a 600 mg oral solution QD during Part 2 only for 20 consecutive days.
16038216|NCT02608463|Behavioral|Pain Catastrophizing Scale|The PCS is a 13-item self-report scale. It asks subjects to reflect on past painful experiences, and to indicate the degree to which they experienced each of 13 thoughts or feelings when experiencing pain, on 5-point scales with the end points (0) not at all and (4) all the time. The PCS yields a total score and three subscale scores assessing rumination, magnification, and helplessness.
16038217|NCT02608463|Behavioral|Pain Intensity Scale, Pain Interference Scale, Pain Behavior Scale|"The 3-item, self-report Pain Intensity assesses how much a person hurts. The first 2 items assess pain intensity over the past 7 days; the last item asks subject to rate pain intensity right now. The 4-item, self-report Pain Interference measures the consequences of pain on relevant aspects of subject's life. It includes impairment in subject's social, cognitive, emotional, physical, & recreational activities. It also incorporates items about sleep and enjoyment of life. It assesses pain interference over the past 7 days.
~The 7-item, self-report Pain Behavior measures behaviors that typically indicate to others that an individual is experiencing pain. Measures include observations (sighing, crying), behaviors (resting, guarding, facial expressions, asking for help), & verbal reports of pain. It assesses pain interference over the past 7 days.
~All three scales, derived from the Patient Reported Outcomes Measurement Information System (PROMIS), are not disease specific."
16038218|NCT02608463|Behavioral|Beck Depression Inventory|The BDI is a widely used instrument that has been used in both clinical and non-clinical setting measuring depressive symptoms. It is a 21 item questionnaire with 4-5 responses for each question. Responses are coded 0-3 for the 4 point scales. The 5 point scales include an additional 2a and 2b response code. The symptom categories reflect overt behavioral manifestations of depression. The instrument has both a high degree of reliability and validity (Beck, Ward, Mendelson, Mock & Erbaugh, 1961).
16038219|NCT02608463|Behavioral|Visual Analogue Scale|100 mm line scale that is subject administered to subjectively rate current pain symptoms. The subject will be instructed to draw a single vertical line that best describes current state.
16038220|NCT02608463|Behavioral|Patient's Global Impression of Change Scale & Clinical Global Impression-Global Improvement Scale|"The PGIC gives a global rating of change in symptoms, activities, emotion, and overall quality of life related to the subject's pain condition. This is a self-rated scale.
~The CGI-I gives a global rating of the improvement/change in the symptoms since the last study visit. This is administered by the MD."
16038221|NCT02608463|Device|Transcranial Magnetic Stimulation|Subjects will undergo daily repetitive transcranial magnetic stimulation (rTMS), defined as Monday through Friday, for a total of 10 consecutive sessions. rTMS will be applied using the NeuroStar TMS Therapy System through a figure-8 coil connected to a magnetic stimulator, which provides a biphasic pulse. The coil is applied to the primary motor cortex, M1, contralateral to the painful side. The optimal stimulus site, motor hot spot, will be determined according to visual detection of muscle twitches, and a resting motor threshold is defined as the minimal intensity necessary to induce at least one visible muscle twitch. An rTMS session consists of 10 trains at 90% intensity of resting motor threshold (one train, 100 pulses at 10 Hz; intertrain interval, 50s).
16038222|NCT02608450|Drug|CB-03-01 cream, 1%|CB-03-01 (cortexolone 17α-propionate) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.
16038223|NCT02608450|Drug|Vehicle cream|Vehicle cream manufactured to mimic look and feel of CB-03-01 but without the active ingredient cortexolone 17α-propionate.
16038224|NCT02608437|Drug|SGI-110|SGI-110: start at 30 mg/m2 s.c. on W0, 3, 6, 9 Day 1 - 5 q21 days. Dose level -1: 15 mg/m2; dose level +1: 45 mg/m2
16038225|NCT02608437|Drug|Ipilimumab|ipilimumab: 3 mg/Kg i.v. over 90 minutes on W1, 4, 7 and 10 for a total of 4 cycles.
16038226|NCT02608424|Device|Foot Mechanical Stimulation (Gondola®, CE marking n° 0476)|The feet mechanical stimulation will be performed by Gondola (Gondola®, CE marking n° 0476).
16038227|NCT02608411|Drug|ARQ197|
16038228|NCT02608398|Other|no intervention|NO intervention by the research group - this is an observational study. urine samples simply collected as children lose weight on their diet and exercise camp
16038229|NCT02608385|Radiation|Stereotactic body radiotherapy (SBRT)|Patients will receive 3 or 5 doses of SBRT to the chosen metastases.
16038230|NCT02608385|Drug|Pembrolizumab|Pembrolizumab (200 mg) given every 3 weeks.
16038231|NCT02608372|Other|LD|Participants ingested 5 g of Laminaria digitata followed by 30 g of corn starch mixed with 200 mL of water.
16038232|NCT02608372|Other|UP|Participants ingested 5 g of Undaria pinnatifida followed by 30 g of corn starch mixed with 200 mL of water.
16038233|NCT02608372|Other|CTR|Participants ingested 30 g of corn starch and 1 g of pea protein powder mixed with 200 mL of water.
16038234|NCT02608359|Drug|Abiraterone Acetate|This is an observational study and participants will not receive any intervention as a part of this study. All prospective participants who will be prescribed abiraterone acetate tablets 250 milligram (mg) treatment based on independent clinical judgment and as per locally approved prescribing information will be enrolled in the PMS. Participants will be exclusively observed for safety.
16038235|NCT02608346|Procedure|Blood sampling|"Patients will have a blood draw at each visit to the hospital,
~with a maximum of 1 blood draw every 3 months, in absence of any abnormal clinical/radiological exam
~with a maximum of 1 blood draw every week, in case of abnormal clinical/radiological exam that requires further investigation"
16038236|NCT02608333|Behavioral|ESDM-12|"ESDM is a comprehensive relational, developmental and behavioral intervention. It's described in a manual for professional (Rogers et al, 2010).
~Children receive ESDM 12H per week by trained therapist. Therapist work in collaboration with parents (at home) and preschool or nursery."
16038237|NCT02608333|Behavioral|control group|"heteregenous as usual community intervention"
16038238|NCT02608320|Drug|Duragesic (Fentanyl Transdermal System [TDS] Small Patches)|Duragesic 12.5 mcg/h (Treatment A) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
16038239|NCT02608320|Drug|New JNJ-35685-AAA-G016 (Fentanyl TDS -Small Patches)|New JNJ-35685-AAA-G016 12.5 mcg/h (Treatment B) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
16038240|NCT02608320|Drug|Aged JNJ-35685-AAA-G016 (Fentanyl TDS Small Patches)|Aged JNJ-35685-AAA-G016 12.5 mcg/h (Treatment C) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
16038282|NCT02608034|Drug|Vemurafenib|Vemurafenib will be administered in both Part 1 and Part 2 at a dose of 960 mg BID for at least 40 conseutive days.
16038241|NCT02608320|Drug|Duragesic (Fentanyl TDS Large Patches)|Duragesic 100 mcg/h (Treatment D) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours, applied to the paraspinal region of the back for 72 hours.
16038242|NCT02608320|Drug|New JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)|New JNJ-35685-AAA-G021 100 mcg/h (Treatment E) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
16038243|NCT02608320|Drug|Aged JNJ-35685-AAA-G021 (Fentanyl TDS Large Patches)|Aged JNJ-35685-AAA-G021 100 mcg/h (Treatment F) in either period 1, 2 or 3 as per treatment sequence, applied to the paraspinal region of the back for 72 hours.
16038244|NCT02608294|Device|Kinesio Taping|The patient is placed on a stretcher, his ankle positioned in plantar flexion and inversion, a measure was held between Point A and B with a tape measure, right after the KT was removed from the paper and cut to the same extent. The KT was pulled to its maximum limit and measured with a tape for a second evaluator. This measure found after the maximum tensile strain represented 100% and a rule of three was applied in order to find the 35% voltage for muscle activation. After finding the measure of 35% strain in centimeters, the evaluator cut KT this measurement and the same was discarded. Finally the tape was positioned at Point A; pulled up to Point B; and fixed. This procedure was carried out with the ankle positioned in plantar flexion and inversion.
16038245|NCT02608294|Device|Kinesio Taping Sham|The sham group received the tape applied without tension. The patient was positioned supine; the ankle was placed in a neutral position (90 degrees); and measured between Point A and Point B with a tape measure placed on the skin was performed. Once registered this measure in centimeters the evaluator cut the KT with the same measure, but without the presence of paper attached to it to ensure that there was no tension, because the KT needs a minimum voltage to be applied on paper. After measured and cut the KT, it was applied to the patient in the supine position with the ankle positioned at 90 degrees with no traction.
16038246|NCT02608281|Device|CONTRAST ENHANCED DUAL ENERGY (CEDEM)|The CEDEM application requires the intravenous injection of iodide contrast agents. For each projection view (CC, MLO) a low and a high energy x-ray image will be acquired after Iodine based contrast medium administration. Patient will undergo CE MRI procedure.
16038247|NCT02608268|Drug|MBG453|anti human TIM-3 monoclonal antibody
16038248|NCT02608268|Drug|PDR001|anti-human PD-1 monoclonal antibody
16038249|NCT02608268|Drug|Decitabine|commercially available chemotherapy
16038250|NCT02608255|Other|blood samples|
16038251|NCT02608242|Drug|YH22189|
16038252|NCT02608242|Drug|Twynsta 80/10mg|
16038253|NCT02608242|Drug|Crestor 20mg|
16038254|NCT02608229|Drug|BVD-523|
16038255|NCT02608229|Drug|Nab-paclitaxel|
16038256|NCT02608229|Drug|Gemcitabine|
16038257|NCT02608229|Procedure|Tumor biopsy|
16038258|NCT02608216|Drug|[18F]FLT|[18F]FLT PET/CT scan, imaging tracer
16038259|NCT02608216|Device|PET/CT|[18F]FLT PET/CT scan
16038260|NCT02608216|Drug|ribociclib|therapeutic
16038261|NCT02608216|Drug|paclitaxel|therapeutic
16038262|NCT02608203|Drug|[68Ga]-DOTANOC PET/CT|
16038263|NCT02608190|Behavioral|Working memory training|See protocol
16038264|NCT02608177|Drug|Linagliptin|Receives 4 weeks of study drug linagliptin
16038265|NCT02608177|Drug|Glipizide|Receives 4 weeks of study drug glipizide
16038266|NCT02608164|Dietary Supplement|3000IU(75μg) vitamin D3|
16038267|NCT02608151|Other|massage with oil|Application or not of an oil consisting of 4 vegetable oils (40% sunflower oil, 3% grape seed oil, 1.5% coriander oil, and 57% of rapeseed oil) during the massage. This oil was chosen due to its composition of essential fatty acids (60%) including: linoleic acid (omega 6,25g 100 g)), linolenic acid (omega 3 5.3g to 100 g) and tocopherol (vitamin E) .
16038268|NCT02608151|Other|massage without oil|
16038269|NCT02608138|Other|Iodine status among portuguese school children|
16038270|NCT02608125|Drug|PRN1371|
16038271|NCT02608112|Drug|Methotrexate|Administered as per investigator's discretion. Investigator could also suggest any other csDMARDs instead of methotrexate.
16038272|NCT02608112|Drug|Tocilizumab|Tocilizumab treatment will be administered SC at the discretion of the investigator in accordance with local clinical practice and local labelling.
16038273|NCT02608099|Drug|Interrupted apixaban|Apixaban dose is administered on the evening prior to the procedure; apixaban dose is held on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.
16038274|NCT02608099|Drug|Uninterrupted apixaban|Intervention description: Apixaban dose is administered on the evening prior to the procedure; apixaban dose is administered on the morning of the procedure; apixaban dose is administered on the evening after the procedure if there were no peri-procedural complications that necessitated withholding anticoagulation for longer duration.
16038275|NCT02608086|Behavioral|Psychoeducation|"Participants in Control Group will be delivered a flyer named What can I do facing a crisis?, containing information about normal reactions to crisis, what to do to return to normal life and which are the signals of an initial trauma."
16038276|NCT02608086|Behavioral|Psychological First Aid|"Psychology students (PFA Providers) will intervene according to an adapted protocol based on the WHO PFA Operation Guide 2012. Protocol for this study contemplates 4 steps: 1. Active Listening 2. Relaxing and Breathing Techniques 3. Help in prioritizing needs 4. Help in contacting network and services. Moreover, participants in this group will receive a brochure with full contact information of public network, and a flyer named What can I do facing a crisis?."
16038277|NCT02608073|Drug|Capecitabine|Participants will receive oral capecitabine, 1000 mg/m^2 BID on Days 1 to 14 of each 21-day cycle, for up to 8 treatment cycles (24 weeks).
16038278|NCT02608073|Drug|Cisplatin|Participants will receive cisplatin, 100 mg/m^2 via IV infusion on Day 1 of each 21-day cycle, for up to 8 treatment cycles (24 weeks).
16038279|NCT02608060|Drug|Epoetin Beta|Dosage at Initiation: Subcutaneous injection of 30000 IU administered once a week. Dosage could be increased to 30000 IU twice a week or 60000 IU once a week after 4 weeks if a blood transfusion was required or hemoglobin level did not increase by at least 0.5 g/dL versus baseline.
16038280|NCT02608034|Drug|Itraconazole|Itraconazole will be administered as a 200 mg oral solution QD during Part 1 only for 20 consecutive days.
16038283|NCT02608008|Device|Data analysis|data parameters Analysis
16038284|NCT02607995|Behavioral|Behavioral standardized manual-based multidisciplinary routine care|Behavioral standardized manual-based multidisciplinary routine care (lifestyle intervention). Six sessions offered over the course of three to six months with a focus on weight loss. The topics 1) causes, consequences and treatment options of obesity, 2) nutrition, 3) eating behaviors and problem solving strategies, 4) self esteem and emotional eating, 5) exercise, and 6) use of media will be covered.
16038285|NCT02607982|Drug|Paclitaxel|PTX 135 mg/m2 was administered intravenously over 3 hours on Day 1 and Day 29 with standard premedications.
16038286|NCT02607982|Drug|Oxaliplatin|oxaliplatin (125mg/ m²) was given as a 2 hours infusion. Chemotherapy was started concurrently with radiation on day 1.
16038287|NCT02607982|Radiation|Radiotherapy|Radiotherapy was given concurrently on the first day of the first cycle of chemotherapy. The GTV received 60Gy (30 fractions at 2Gy per fraction) and CTV was 40 Gy (20 fractions at 2Gy per fraction). Radiotherapy was delivered in three-dimensional conformal technique (3D-CRT) and no intensity-modulated radiotherapy was used.
16038288|NCT02607969|Other|Home program|Parents will be educated about the home program which consisted of positioning the neck and head, sleep in alternating head positions and in side-laying to increase head shape symmetry and place infants, when awake and under supervision, regularly in the prone position a day to stimulate normal motor development (tummy time), decreasing the time spent in car seat at supine position. Environmental settings also were given to challenge the baby look through from the side no flattening to room, place colorful and sonorous toys or mirror on the opposite of the flattening side, and stimulate active rotation by communicating with baby from this side. Handling strategies, stretching and strengthening exercises will given for CMT
16038289|NCT02607956|Drug|DTG|50 mg tablets administered orally, once daily, without regard to food
16038290|NCT02607956|Drug|F/TAF|200/25 mg tablets administered orally, once daily, without regard to food
16038291|NCT02607956|Drug|B/F/TAF|50/200/25 mg FDC tablets administered orally, once daily, without regard to food
16038292|NCT02607956|Drug|DTG Placebo|Tablets administered orally, once daily, without regard to food
16038293|NCT02607956|Drug|F/TAF Placebo|Tablets administered orally, once daily, without regard to food
16038294|NCT02607956|Drug|B/F/TAF Placebo|Tablets administered orally, once daily, without regard to food
16038295|NCT02607943|Drug|Insulin Glargine|Insulin Glargine Versus Regular Insulin Based Regimens in Glycemic Control
16038296|NCT02607943|Drug|Regular Insulin|Insulin Glargine Versus Regular Insulin Based Regimens in Glycemic Control
16038297|NCT02607930|Drug|ABC/DTG/3TC|600/50/300 mg tablets administered orally, once daily, without regard to food
16038298|NCT02607930|Drug|B/F/TAF|50/200/25 mg tablets administered orally, once daily, without regard to food
16038299|NCT02607930|Drug|ABC/DTG/3TC Placebo|Tablets administered orally, once daily, without regard to food
16038300|NCT02607930|Drug|B/F/TAF Placebo|Tablets administered orally, once daily, without regard to food
16038301|NCT02607917|Other|Mass Media plus clinic intervention.|
16038302|NCT02607917|Other|Media|
16038303|NCT02607904|Drug|GWP42003-P|Clear, colorless to yellow solution containing cannabidiol (CBD) dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
16038304|NCT02607891|Drug|GWP42003-P|Clear, colorless to yellow solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
16038305|NCT02607891|Drug|Placebo|Clear, colorless to yellow solution containing the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
16038306|NCT02607865|Drug|semaglutide|Oral administration once-daily
16038307|NCT02607865|Drug|sitagliptin|Oral administration once-daily
16038308|NCT02607865|Drug|placebo|Oral administration once-daily
16038309|NCT02607852|Device|iPads|The current study will help determine if using Burn Outcomes Questionnaire and 17- item Pediatric Symptom Checklist (PSC-17) feedback data, collected on iPads or online, over the course of patient treatment will be useful for the physicians and ultimately impact the recovery of the patient.
16038310|NCT02607839|Biological|glucose or normal saline|20% glucose solution or normal saline, intravenous infusion
16038311|NCT02607826|Procedure|Starvation|Short-term starvation for a timeframe beginning 24h prior to chemotherapy administration, lasting until 6h after administration
16038312|NCT02607813|Drug|LXH254|pan-RAF inhibitor
16038313|NCT02607813|Drug|PDR001|Biological: PDR001 anti-PD1 antibody
16038314|NCT02607800|Drug|SOF/VEL/VOX|400/100/100 mg tablet administered orally once daily with food
16038315|NCT02607800|Drug|SOF/VEL|400/100 mg tablet administered orally once daily with or without food
16038316|NCT02607787|Behavioral|Exercise|The exercise programme aims to gradually increase participants physical activity levels so that they start achieving the recommended levels of at least 150 minutes moderate intensity aerobic activity per week and strengthening exercise for all major muscle groups at least twice per week.
16038317|NCT02607787|Other|Control|The control group will receive usual care whilst attending for the same 4 visits as the intervention group and have the same outcome measures tested. They will however receive the intervention information on their last visit.
16038318|NCT02607774|Drug|Midazolam|midazolam administered to all patients Days -7, 1 and 35.
16038319|NCT02607774|Drug|AIN457|secukinumab administered at Weeks 0, 1, 2, 3, 4, 8, 12, 16, 20 and 24
16038320|NCT02607761|Other|Video|Video-Audio Media
16038321|NCT02607748|Other|18F-NaF PET and coronary CTA imaging|
16038322|NCT02607735|Drug|SOF/VEL/VOX|400/100/100 mg fixed dose-combination (FDC) tablet administered orally once daily with food
16038323|NCT02607735|Drug|Placebo|Tablet administered orally once daily with food
16038324|NCT02607722|Drug|Nintedanib|
16038325|NCT02607709|Procedure|Lymphadenectomy in conjugation with nephroureterectomy|"Lymphadenectomy (intervention group only):
~Lymphadenectomy performs in four fractions on the right side and two fractions on the left side according to Dissection template (Appendix 1). Renal hilar nodes are included in fraction 1 and 3, respectively."
16038326|NCT02607709|Procedure|Nephroureterectomy without lymphadenectomy|Removing the kidney, ureter and bladder cuff
16038327|NCT02607696|Drug|Zolpidem Hemitartarate|
16038328|NCT02607683|Drug|XAF5 (concentration A: 0.1%)|
16038329|NCT02607683|Drug|XAF5 (concentration B: 0.035%)|
16038343|NCT02607592|Drug|cisplatin and pemetrexed|cisplatin 25mg/m2 d1-3+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle）
16038344|NCT02607592|Drug|nadaplatin+pemetrexed|nadaplatin 80mg/m2 d1+pemetrexed 500mg/m2 d1 （Every three weeks for a treatment cycle）
16038345|NCT02607579|Drug|Exparel|
16038346|NCT02607579|Drug|Ropivacaine|
16038347|NCT02607566|Behavioral|Yoga|
16038348|NCT02607566|Behavioral|Standard Exercise Program|twice weekly aerobic exercise program, 60 minutes for 12 weeks
16038349|NCT02607553|Drug|G-202|G-202 administered by intravenous infusion on Days 1, 2 and 3 of each 28-day cycle until disease progression
16038350|NCT02607540|Other|2 cycles cisplatin-5-fluorouracil|2 cycles cisplatin-5-fluorouracil(PF 2 cycles): cisplatin: 75mg/m2 d1，29; 5-fluorouracil：750mg/m2 CIV24h d1-4，d29-32.
16038351|NCT02607540|Other|4 cycles cisplatin-5-fluorouracil|4 cycles cisplatin-5-fluoroura(PF 4 cycles): cilcisplatin: 75mg/m2 d1，29, 57, 85; 5-fluorouracil：750mg/m2 CIV24h d1-4，d29-32, d57-60, d85-88.
16038352|NCT02607540|Radiation|Radiotherapy|concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity
16038353|NCT02607527|Device|Mitral Valve IRIS Ring|Transcatheter implantation of the IRIS
16038354|NCT02607514|Behavioral|hyperthermic yoga|heated yoga, 90-minutes
16038355|NCT02607501|Device|Implant eCLIPs|Implant eCLIPs at target bifurcation aneurysm
16038356|NCT02607488|Drug|Placebo|"Participants will receive an intravenous bolus of 0.1 mL/kg of saline 0.9% solution followed by a continuous infusion 0.1 mL/kg/h of Saline 0.9% which will be continued for 24 hours after surgery.
~All medications in the study protocol will be based on the dosing body weight [ideal body weight (IBW) + 0.4 × (actual body weight-IBW)]"
16038357|NCT02607488|Drug|Lidocaine 1%|"Participants will receive an intravenous bolus of 0.1 mL/kg of lidocaine 1.5% solution followed by a continuous infusion 0.1 mL/kg/h of lidocaine 1% solution which will be continued for 24 hours after surgery.
~All medications in the study protocol will be based on the dosing body weight [ideal body weight (IBW) + 0.4 × (actual body weight-IBW)]"
16038358|NCT02607488|Drug|Lidocaine 1.5%|"Participants will receive an intravenous bolus of 0.1 mL/kg of lidocaine 1.5% solution followed by a continuous infusion 0.1 mL/kg/h of lidocaine 1.5% solution which will be continued for 24 hours after surgery.
~All medications in the study protocol will be based on the dosing body weight [ideal body weight (IBW) + 0.4 × (actual body weight-IBW)]"
16038359|NCT02607488|Drug|Lidocaine 2%|"Participants will receive an intravenous bolus of 0.1 mL/kg of lidocaine 1.5% solution followed by a continuous infusion 0.1 mL/kg/h of lidocaine 2% solution which will be continued for 24 hours after surgery.
~All medications in the study protocol will be based on the dosing body weight [ideal body weight (IBW) + 0.4 × (actual body weight-IBW)]"
16038360|NCT02607475|Device|Robotic telesonography (MELODY Patient System, AdEchoTech)|Robotic telesonography using the MELODY Patient System (AdEchoTech) in conjunction with the SonixTablet ultrasound system (BK Ultrasound, formerly Ultrasonix).
16038361|NCT02607475|Device|Conventional sonography (EPIQ 5, Philips or LOGIQ E9, GE Healthcare)|Conventional sonography using EPIQ 5 (Philips) or LOGIQ E9 (GE Healthcare) ultrasound systems.
16038362|NCT02607462|Biological|PRP|
16038363|NCT02607462|Other|Placebo|
16038364|NCT02607449|Drug|FS-1|FS-1 is a liquid solution for internal intake and has antimicrobial and antibacterial activities.
16038365|NCT02607449|Drug|Placebo|Placebo without any active pharmaceutical ingredients
16038366|NCT02607436|Drug|Sarpogrelate|Sarpogrelate
16038367|NCT02607436|Drug|Aspirin|Aspirin
16038368|NCT02607423|Drug|Cisplatin|Given IV
16038369|NCT02607423|Procedure|Computed Tomography|Undergo 18F-FDG PET/CT
16038370|NCT02607423|Drug|Docetaxel|Given IV
16038371|NCT02607423|Radiation|Fludeoxyglucose F-18|Undergo 18F-FDG PET/CT
16038372|NCT02607423|Drug|Gemcitabine Hydrochloride|Given IV
16038373|NCT02607423|Drug|Pemetrexed Disodium|Given IV
16038374|NCT02607423|Procedure|Positron Emission Tomography|Undergo 18F-FDG PET/CT
16038375|NCT02607410|Drug|sitagliptin|patients with type 2 diabetes,inadequately controlled with metformin plus glyburide, HbA1c between 6.6 to 10%, will be randomized to the addition of sitagliptin (Sitagliptin Group) or of bedtime NPH insulin (NPH Group) during one year
16038376|NCT02607410|Drug|NPH insulin|patients with type 2 diabetes,inadequately controlled with metformin plus glyburide, HbA1c between 6.6 to 10%, will be randomized to the addition of sitagliptin (Sitagliptin Group) or of bedtime NPH insulin (NPH Group) during one year
16038377|NCT02607384|Behavioral|Eyeglass wearing|Children found to require eyeglasses will be given two pairs free of charge
16038378|NCT02607384|Behavioral|Orthoptic exercises|Children found to have convergence insufficiency will be prescribed orthoptic exercises
16038379|NCT02607384|Other|Specialist referral|Children found to any other eye condition will be referred to a pediatric eye care specialist
16038380|NCT02607371|Other|VKAs|VKA have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study)
16038381|NCT02607371|Other|NOACs including Rivaroxaban (Xarelto, BAY59-7939)|NOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study)
16038382|NCT02607371|Other|Edoxaban|NOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study)
16038471|NCT02606591|Behavioral|Cognitive Tests|During the EEG, participant asked to wear headphones and do some simple tests on the computer that measure their abilities to see, hear, and understand information.
16040762|NCT02590744|Behavioral|eye patch|cover the sick eye with eye patch preoperatively for 3 hours
16038383|NCT02607371|Other|Apixaban|NOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study)
16038384|NCT02607371|Other|Dabigatran-etexilate|NOAC have been prescribed in the customary manner in accordance with the terms of the marketing authorization; decision to prescribe these agents has been made at least 3 months prior to study inclusion; assignment of a patient to a particular therapeutic strategy is only made retrospectively (treatment decision falls within current practice and the prescription of the medicines is separated from the decision to include the patient in the study)
16038385|NCT02607358|Other|blood sampling for HOTPR-testing|All subjects are tested for responderstatus using the VerifyNow System
16038386|NCT02607345|Dietary Supplement|Zusto|25gr
16038387|NCT02607345|Dietary Supplement|Glucomedics®|25gr
16038388|NCT02607332|Drug|Paclitaxel|
16038389|NCT02607319|Drug|Bemiparin sodium|Bemiparin sodium 3,500 IU will be started on the evening of the same day of embryo transfer and until the day of pregnancy test. If the test is positive, Bemiparin will be discontinued by the end of the 12th week of gestation.
16038390|NCT02607306|Drug|insulin degludec/liraglutide|Injected s.c. / subcutaneously (under the skin) once daily (OD) , in combination with pre-trial OAD (oral antidiabetic drug)kept in unchanged dose.
16038391|NCT02607306|Drug|insulin degludec|Injected s.c. / subcutaneously (under the skin) once daily (OD) , in combination with pre-trial OAD (oral antidiabetic drug)kept in unchanged dose.
16038392|NCT02607306|Drug|liraglutide|Injected s.c. / subcutaneously (under the skin) once daily (OD) , in combination with pre-trial OAD (oral antidiabetic drug)kept in unchanged dose.
16038393|NCT02607293|Drug|Gonal-f®|Recombinant human follicle stimulating hormone (r-FSH) will be administered subcutaneously (SC) for about 10 to 20 days along with the ART regimen as routinely practiced by Investigators and according to licensed summary of product characteristics (SmPC label) for the ovarian stimulation.
16038394|NCT02607293|Drug|Long GnRH agonist|As a part of the ART regimen GnRH-agonist will be administered for about 14 to 20 days until down regulation is satisfied as judged by investigator.
16038395|NCT02607293|Drug|GnRH antagonist|As a part of ART regimen GnRH-antagonist will be initiated and regimen will be as routinely practiced by Investigators and according to licensed SmPC label.
16038396|NCT02607280|Drug|DS-5565|DS-5565 15 mg (for moderate renal impairment) or 7.5 mg (for severe renal impairment), oral administration, Treatment period; 2-weeks titration and 12-weeks fixed dose
16038397|NCT02607267|Other|LSG and LRYGB|The role of the Edmonton Obesity Staging System in predicting post-operative outcome and 30-day mortality after metabolic surgery (LSG and LRYGB)
16038398|NCT02607254|Drug|Pregabalin|Pregabalin will be given to the patients, starting at 75 mg BID and increased weekly to reach 225 mg BID for 8 weeks. During withdrawal phase, dose of pregabalin will be kept the same for patients who are randomized to the pregabalin withdrawal group.
16038399|NCT02607254|Drug|Placebo|Placebo will be given to the patients that are randomized to placebo during withdrawal phase.
16038400|NCT02607241|Device|OCT-guided BRS implantation|Implantation of a BRS using OCT to measure vessel size, choose BRS size and length and assess implantation results and the need of further postdilations
16038401|NCT02607241|Device|FFR-guided DCB-only PCI|PCI performed under FFR guidance using following algorithm: (1) predilation followed by angiographic assessment of residual stenosis and dissections; (2) evaluate suitability for DCB-only, which is deemed feasible if the FFR > 0.8, residual diameter stenosis < 40% and no flow-limiting dissections are observed; (3) DCB dilation and (4) assessment of final results using FFR and QCA measurements. Provisional stenting is allowed only if the final PCI results are not acceptable (flow-limiting dissection, residual stenosis > 40% or FFR < 0.8).
16038402|NCT02607228|Drug|Alobresib|Tablet administered orally once daily.
16038403|NCT02607228|Drug|Enzalutamide|Capsules administered orally once daily.
16038404|NCT02607215|Drug|Vinorelbine|25 mg/m2, D1, D8
16038405|NCT02607215|Drug|DDP|75 mg/m2, D1
16038406|NCT02607202|Drug|nab-paclitaxel|
16038407|NCT02607202|Drug|Carboplatin|
16038408|NCT02607202|Drug|Gemcitabine|
16038409|NCT02607176|Drug|Heweizhixie capsule|3 #, Tid, Oral for 3 days
16038410|NCT02607163|Drug|dexmedetomidine|Immediately after the induction of anesthesia, patients in the dexmedetomidine group received dexmedetomidine continuous intravenous (IV) infusion of 0.4 mcg/kg/h until 24 hours after surgery.
16038411|NCT02607163|Drug|saline|same infusion rate (received equal volume of normal saline), IV, The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery.
16038412|NCT02607150|Other|Cerebral Oxygenation Changes|Monitor cerebral oxygenation changes in patients receiving blood transfusions who are undergoing spinal fusion surgery.
16038413|NCT02607137|Behavioral|Health Education|Information on healthy living style in relation to physical activity
16038414|NCT02607124|Drug|Ribociclib|
16038415|NCT02607111|Drug|Dalteparin|
16038416|NCT02607072|Drug|Acetylsalicylic acid (ASA)/aspirin 200 mg daily|
16038417|NCT02607072|Drug|Acetylsalicylic acid (ASA)/aspirin 100 mg daily|
16038418|NCT02607072|Drug|Placebo|
16038419|NCT02607059|Other|Registry|
16038420|NCT02607046|Other|Exercise training|The exercise program includes supervised and home-based walking and strength exercise.
16038421|NCT02607046|Other|NMES|This intervention consists of using neuromuscular electrical stimulation (NMES) as a form of passive exercise for muscles in the legs.
16038422|NCT02607033|Other|Exercise|Individuals will be asked to walk 3 times a week on a treadmill (initially starting at 15 minutes and progressing up to 40 minutes) and participate in a short weight training program focused on increasing strength in the legs.
16038423|NCT02607033|Other|Weight Loss|Individuals will be asked to meet with a registered dietitian once a week to discuss strategies to reduce daily caloric intake to gradually reduce body weight over 6 months.
16038472|NCT02606591|Other|Hair Sample|Participants provide a sample of hair at baseline (near the beginning of school), and follow-up (near the end of school). Sample tested to measure cortisol levels.
16038424|NCT02607020|Other|Physical exercises in an self-management setting|"Workout sessions will be based on the principle of self-management, without direct supervision of a therapist. Sessions will include:
~1. Twenty minutes of aerobic exercises 1.2. Five to ten minutes of stretching exercises. 2.3. Fifteen to twenty minutes of resistance exercises to improve muscle strength of lower limbs. The targeted muscles will be the hip flexors, the knee extensors and flexors, and the foot extensors and plantar flexors. These exercises will comply with the recommendations of the American College of Sports Medicine (ACSM, 2011). Patients will be asked to perform muscle contractions against the gravity (about 15 repeats). There will be on average 5 to 6 series per session. Several muscle groups of the lower limbs will be trained during the same session."
16038425|NCT02607020|Other|Relaxation|The relaxation sessions of the control group will be carried out with the help of soothing music. Patients will receive a Compact Disc (CD) of soothing music at the inclusion. Patients will also have an electronic training logbook that will be reviewed each week by a therapist. They will have a phone contact with the therapist every two weeks, to discuss about the treatment and adapt it if necessary. They will also have a reminder session every four weeks.
16038426|NCT02607007|Other|2% M.F. Milk|
16038427|NCT02607007|Other|White Bread|
16038428|NCT02607007|Other|Strawberry Jam|
16038429|NCT02607007|Other|31% M.F. Cheddar Cheese|
16038430|NCT02607007|Other|2% M.F. Plain Greek yogurt|
16038431|NCT02607007|Other|Soy Beverage|
16038432|NCT02607007|Other|Water|
16038433|NCT02606994|Drug|Oral Defense Toothpaste|Brush with a Oral Defense Toothpaste three times per day during the study
16038434|NCT02606994|Drug|Crest Toothpaste|Brush with Crest Toothpaste three times per day during the study
16038435|NCT02606994|Drug|Magic Mouth Rinse|Participants using Crest Toothpaste who require additional pain intervention for their oral mucositis will be provided Magic Mouth Rinse
16038436|NCT02606981|Device|Water chlorination by the Flogenic|The chlorine doser delivers a constant amount of chlorine into water as it flows into a holding tank. The water is then piped to public and private taps.
16038437|NCT02606981|Device|Active control, vitamin C dosing into water|The control group will receive a vitamin C dosing device that looks identical to the intervention chlorine doser installed in the holding tank that feeds their shared water access point.
16038438|NCT02606955|Device|BIA DW|All patients undergo a Clinical DW assessment. Then, they undergo a HD session in which BIA DW (injection of 800 microAmpere at 50 kilohertz alternating sinusoidal current with a standard tetrapolar technique) is determined. BIA DW is determined by performing the REsistance Stabilization Test (REST).
16038439|NCT02606942|Other|Questionnaires, physical exam, US of the knee|Function and pain questioners, physical findings and sonographic study of the knee joint
16038440|NCT02606916|Radiation|SMART|Once-daily simultaneous modulated accelerated radiotherapy(64Gy/30f )
16038441|NCT02606916|Drug|DDP|DDP(25 mg/m2.qw) for six weeks.
16038442|NCT02606916|Drug|S-1|S-1(40 mg/m2.Bid .po) on D1-14，D22-35 during radiotherapy
16038443|NCT02606903|Drug|BI 695501 prefilled syringe|
16038444|NCT02606903|Drug|BI 695501 autoinjector|
16038445|NCT02606890|Other|MRI|Stroke patients routinely undergo MRI at Charite Campus Benjamin Franklin. Type of MRI stroke pattern is evaluated with regard to presence or detection of (new) atrial fibrillation.
16038446|NCT02606877|Drug|nintedanib|
16038447|NCT02606877|Drug|pirfenidone|
16038448|NCT02606864|Drug|Nifurtimox (BAYa2502)|Oral Intake of 4 x 30 mg nifurtimox tablets
16038449|NCT02606838|Device|Styx Lancing Device|Untrained Persons With Diabetes used the Styx Lancing Device with 28 and 30 Gauge lancets to obtain fingerstick and Alternate Site palm capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all.
16038450|NCT02606825|Other|Registry of AML patients > 60 years|
16038451|NCT02606812|Dietary Supplement|Traditional-food|Intake of ethnic local food
16038452|NCT02606799|Device|CytoSorb cytokine elimination|Hemoperfusion using continuous veno-venous hemofiltration (citrate regional anticoagulation) with CytoSorb cytokine elimination over a period of 48h immediately following admission to the intensive care unit
16038453|NCT02606786|Other|Lumbopelvic stabilization exercises|The objective of this exercise program is to recruit and train the primary stabilizing muscles of the spine in order for them to more appropriately support the spine.
16038454|NCT02606773|Drug|Ascorbic Acid|Ascorbic acid in different ways and doses
16038455|NCT02606760|Drug|P-3073|
16038456|NCT02606760|Drug|Vehicle of P-3073|
16038457|NCT02606734|Device|Coronary Angiography|The DyeVert System will be used during coronary angiographic procedures which include: diagnostic only, diagnostic + PCI or PCI only cases.
16038458|NCT02606708|Radiation|Accelerated intensity modulated radiation therapy (AIMRT)|
16038459|NCT02606695|Device|NuvaMap O.R.|Clinical imaging software used to assess intraoperative spinal alignment
16038460|NCT02606695|Device|NuvaMap|Clinical imaging software used to assess spinal alignment
16038461|NCT02606682|Drug|NPT200-11|Single doses of NPT200-11capsules, orally administered
16038462|NCT02606682|Drug|Placebo|Single doses of microcrystalline cellulose capsules, orally administered
16038463|NCT02606669|Dietary Supplement|Meal Replacement|Using a Meal Replacement product, supplemented by protein powder and multivitamin
16038464|NCT02606643|Procedure|Slight traction|Slight traction will be applied to the balloon catheter
16038465|NCT02606643|Procedure|Foley Catheter to no traction|Foley Catheter to no traction
16038466|NCT02606630|Drug|ABT-555|ABT-555 will be administered on Visit 4 in Part 2 only
16038467|NCT02606617|Drug|Mosapride|Mosapride(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator.
16038468|NCT02606617|Drug|Placebo|Placebo(5mg, 3/d), antidiabetic drug except DPP-IV inhibitor and GLP-1 receptor activator.
16038469|NCT02606604|Device|RT 300: Lower Extremity Cycling|Individuals will be randomly assigned to either the FES cycling or cycling only group and will perform lower extremity cycling. Individuals will participate in an interval training cycling program 3 times per week for 8 weeks.
16038470|NCT02606591|Procedure|Electroencephalograph|EEG performed at beginning and end of school year.
16038542|NCT02606032|Drug|Terbinafine|active comparator
16038473|NCT02606578|Other|Questionnaires|"The study team will collect information from your medical record regarding: demographics, operation, nutritional status, laboratory values, testing results, complications, hospital data, cost, length of stay, past medical history and clinical outcomes.
~At your clinical follow-up visits (~4 weeks, 6 months, and 12 months post operation), a study coordinator will meet with you to assess for adverse events and to have you complete research questionnaires. Alternatively, the study coordinator may call you to assess for adverse events and ask if we can mail you the research questionnaires to complete and mail back.
~You will also be asked to complete the research questionnaires a minimum of once a year for your lifetime: A study coordinator will call you and ask if we can mail you questionnaires to complete and mail back."
16038474|NCT02606565|Biological|Intervention arm: 4% chlorhexidine|See previous description
16038475|NCT02606552|Drug|Dabigatrain plus aspirin|Dabigatran (Pradaxa®) is indicated for the prevention of thrombotic events (for example stroke or heart attack) in people with atrial fibrillation. Aspirin is indicated for the prevention of stent thrombosis and myocardial infarction in patients treated with drug-eluting stents. Patients will be randomized to stop clopidogrel (maintain dabigatran + aspirin) at 3 months after PCI.
16038476|NCT02606552|Drug|Dabigatrain plus clopidogrel|Clopidogrel is indicated for the prevention of stent thrombosis and myocardial infarction in patients treated with drug-eluting stents. Patients will be randomized to stop aspirin (maintain dabigatran + clopidogrel) at 3 months after PCI.
16038477|NCT02606552|Device|Amplazter Cardiac Plug (ACP)|Patients allocated to the intervention group should be received percutaneous closure of the LAA by use of the ACP device (St. Jude Medical, St Paul, MN, USA).
16038478|NCT02606539|Procedure|Total abdominal hysterectomy and methotrexate|After written consent laparotomy will be done then pelvic examination for extra uterine spread, palpation of liver, omentum for any gross lesions and then hystrectomt bilateral salpigooophrectomy will be done) plus single course methotrexate(anti folate chemotheraputic agent, vial form given by intramuscular injection) 1mg/kg every other day alternating with calcium folinate 0.1 mg/kg for 4 doses each cycle then measuring B-HCG (the cycle may be repeated until normalization of B-HCG)
16038479|NCT02606539|Drug|Methotrexate plus folinic acid alone|methotrxate 1mg/kg every other day alternating with calcium folinate 0.1 mg/kg for 4 doses each cycle then measuring B-HCG and cycle repeated until normalization of B-HCG
16038480|NCT02606526|Biological|BCG at birth|See previous description
16038481|NCT02606526|Biological|Control arm: Delayed BCG|See previous description
16038482|NCT02606513|Other|MR Urography; CT Urography|
16038483|NCT02606500|Drug|Elonva|"20 obese women will be the study group and 20 normal weighing women will be the control group. Both groups will receive 150 mcg of Elonva for controlled ovarian hyperstimulation (COH). Gonadotropin-releasing hormone (GnRH) antagonist will be used to prevent premature luteinizing hormone (LH) surge. Additional daily doses of 200 IU of recombinant follicle stimulating hormone (rFSH) will be used if necessary. Human chorionic gonadotropin (hCG) will be used for oocyte maturation. 2 mature follicles will be aspirated separately in each patient. Cumulus cell (CC) samples will be collected and stored on -80 oC for subsequent analysis. Clinical and molecular parameters of IVF success will be assessed and compared between the groups.
~The exclusion criteria will be: polycystic ovary syndrome, severely abnormal sperm parameters, and age > 38 years."
16038484|NCT02606461|Drug|Selinexor|Selinexor 60mg
16038485|NCT02606461|Drug|Placebo|
16038486|NCT02606448|Drug|Liposomal bupivacaine|Local infiltration of liposomal bupivacaine
16038487|NCT02606448|Procedure|Femoral nerve block|Pre-operative femoral nerve block
16038488|NCT02606448|Drug|Ropivicaine|Ropivicaine was used in all femoral nerve blocks
16038489|NCT02606435|Procedure|percutaneous coronary intervention (PCI)|percutaneous coronary intervention (PCI) by stent implantation
16038490|NCT02606435|Device|thrombus aspiration|thrombus aspiration with export catheter
16038491|NCT02606422|Device|Active HD-tDCS plus Speech-Language Therapy|Stimulation will be delivered by a battery-driven constant current stimulator. The electrical current will be administered to a pre-specified region of the brain (inferior frontal gyrus). The stimulation will be delivered at an intensity of 2mA (estimated current density 0.04 mA/cm2; estimated total charge 0.048C/cm2) in a ramp-like fashion for a maximum of 20 minutes. Speech-language therapy will be oral and written naming.
16038492|NCT02606422|Device|Sham plus Speech-Language Therapy|Speech-language therapy will be administered during sham stimulation. Current will be administered in a ramp-line fashion but after the ramping the intensity will drop to 0 mA. Speech-language therapy will be oral and written naming.
16038493|NCT02606409|Drug|Dexmedetomidine|Dexmedetomidine sedation at a starting dose of 0.2-7.0 µg/kg/hour.
16038494|NCT02606409|Drug|Propofol|Propofol sedation at a starting dose of 10-70 µg/kg/hour.
16038495|NCT02606396|Procedure|Cryotherapy|Cryotherapy employs thermal ablation to treat esophageal cancer and BE. Ablation is achieved by intracellular disruption and ischemia that is produced by freeze-thaw cycles using liquid nitrogen or carbon dioxide
16038496|NCT02606396|Procedure|Esophagogastroduodenoscopy (EGD)|EGD is a diagnostic procedure that allows the physician to diagnose and treat problems in the upper gastrointestinal (UGI) tract. The doctor uses a long, flexible, lighted tube called an endoscope.
16038497|NCT02606396|Procedure|Endoscopic ultrasound (EUS)|EUS is a procedure that allows a doctor to obtain images and information about the digestive tract and the surrounding tissue and organs, including the lungs. Ultrasound testing uses sound waves to make a picture of internal organs.
16038498|NCT02606383|Drug|Dapaconazole|
16038499|NCT02606383|Drug|Ketoconazole|
16038500|NCT02606370|Other|Unstable shoe|Wearing Unstable shoes during 1 month
16038501|NCT02606357|Drug|INSULIN GLARGINE|"Pharmaceutical form:Solution
~Route of administration: Subcutaneous"
16038502|NCT02606344|Other|Mico-finance based intervention|
16038503|NCT02606331|Procedure|Piezosurgery|Corticotomy cuts will be performed by this technique.
16038504|NCT02606331|Radiation|ER:YAG laser|Corticotomy cuts will be performed by this technique.
16038543|NCT02606032|Drug|Placebo|identical placebos to all antibiotics
16038544|NCT02606006|Behavioral|Canine Animal-Assisted Therapy|Canine Animal-Assisted Therapy is the inclusion of a certified therapy canine in the standard of care physical therapy session, such as for walking, fetching balls, standing/petting, etc.
16040763|NCT02590744|Behavioral|non-eye patch|do not cover the sick eye with eye patch preoperatively
16038505|NCT02606318|Other|Adjusted the challenge-skill balance|In the first session of occupational therapy, the therapist assessed the client's problems in daily living using the Canadian Occupational Performance Measure. Based on the problems identified, an activity that could be supported in day care was selected. In the second session, the client performed the selected activity, and then the challenge and skill levels of the activity were evaluated. Based on these levels, adjustment of the challenge-skill balance in the activity was attempted. Occupational therapy consisted of 10 sessions of 20 minutes held over about 10 weeks
16038506|NCT02606318|Other|Non-adjusted the challenge-skill balance|The first and second sessions were conducted in the same way as for the experimental group, except that the therapists were not informed of the client's subjective perception of the challenge and skill levels for the activity. From the third session, the therapists simply assessed the client's performance and conducted the therapy in the normal manner for the day care center, following the general guidelines for occupational therapy practice
16038507|NCT02606305|Drug|Mirvetuximab soravtansine|
16038508|NCT02606305|Drug|Bevacizumab|
16038509|NCT02606305|Drug|Carboplatin|
16038510|NCT02606305|Drug|Pegylated Liposomal Doxorubicin|
16038511|NCT02606305|Drug|Pembrolizumab|
16038512|NCT02606292|Procedure|Photoacoustic endoscopy|
16038513|NCT02606292|Procedure|Endoscopic ultrasound (standard of care)|
16038514|NCT02606292|Procedure|Endoscopic surgery (standard of care)|
16038515|NCT02606279|Drug|valsartan|Valsartan will be given in increasing doses (from 40 mg to 80 mg) to those in the valsartan arm.
16038516|NCT02606279|Other|Placebo|
16038517|NCT02606266|Drug|Valganciclovir|Oral valganciclovir (Rovalcyte 50 mg/ml, powder for oral suspension) at a dose of 16 mg/kg 2 times/day (max 900 mg/d) for 6 weeks.
16038518|NCT02606253|Drug|tolvaptan|Tolvaptan (Samsca) is a vasopressin 2 receptor antagonist that works in the collecting duct of the nephron to cause diuresis.
16038519|NCT02606253|Drug|Chlorothiazide|Chlorothiazide (Diuril) is an intravenous thiazide diuretic that works in the distal convoluted tubule of the nephron to cause diuresis.
16038520|NCT02606253|Drug|Metolazone|Metolazone (Zaroxolyn) is an oral thiazide diuretic that works in the distal convoluted tubule of the nephron to cause diuresis.
16038521|NCT02606240|Device|CO2 removal with PRISMALUNG in ARDS|Observational study of patients with mild to moderate Acute Respiratory Distress Syndrome (ARDS) submitted to Extracorporeal CO2 removal (ECCO2R) with the PRISMALUNG device to allow ultraprotective mechanical ventilation with tidal volume reduction (from 6 to 4 ml/kg, predicted body weight) and plateau pressure reduction from 28-30 to 23-25 cmH2O.
16038522|NCT02606227|Behavioral|Financial incentive|Vouchers
16038523|NCT02606227|Other|No financial incentive|No financial intervention
16038524|NCT02606214|Drug|TBA-354|
16038525|NCT02606214|Drug|TBA-354 Placebo|
16038526|NCT02606201|Other|Peri sphincter injection Autologous myofibers|"The first step of the procedure consists to harvest a muscle fragment from the lower part of the rectus abdominis muscle of the abdomen approached by a short incision. Injectable myofiber cores will be prepared by hydrodissection of the muscle biopsy.
~All myofibers cores will be suspended in autologous serum prepared by centrifugation before the incision.
~During the second step of the procedure, the myofibers will be injected percutaneously into the peri-sphincter region under endoscopic and radiographic control."
16038527|NCT02606188|Device|Modified High-flow nasal cannula|Modified High-flow nasal cannula
16038528|NCT02606188|Device|nasal cannula|Conventional oxygen therap
16038529|NCT02606175|Other|Taking questionnaires and tests|"At predefined timepoints:
~2 tests for health literacy: New Vital Sign-Dutch version (NVS-D) and Functional, Communicative and Critical Health Literacy (FCCHL)
~1 test for medication adherence: BAASIS
~1 questionnaire about demographic factors (weight, income, sex, age, financial situation,...)
~1 test about medication knowledge"
16038530|NCT02606149|Behavioral|Truthful information on chemotherapy risks|One of two trained oncologist will meet the patient and inform him following an interview-guideline
16038531|NCT02606149|Behavioral|Standard of information|
16038532|NCT02606136|Drug|pamrevlumab (FG-3019)|pamrevlumab (FG-3019), 10 mg/mL, single dose vials
16038533|NCT02606123|Drug|EPI-506|"Patients will receive EPI-506 as an oral softgel capsule.
~Part 1:
~Approximately six dose levels of EPI-506 will be studied, beginning at 80 mg/day. During the Single-Dose Period, patients will first receive a dose of EPI-506 in the fasted state followed by 2 days of washout, and then patients will receive a second dose of EPI-506 in the fed state followed by 2 days of washout. Patients will then enter the Multiple Dosing and Long-term Dosing Period where they will receive once or twice daily dosing in a fed or fasted state until they meet discontinuation criteria.
~Part 2:
~The dose in Part 2 will be determined in Part 1 of the study. Patients will receive the Part 2 dose daily until they meet discontinuation criteria."
16038534|NCT02606097|Drug|regorafenib|
16038535|NCT02606084|Drug|Esketamine|Participants will self-administer esketamine solution intranasally 28 milligram (mg) on Day 1.
16038536|NCT02606071|Device|CRT-D|HF patients treated in clinical practice with a CRT-D device
16038537|NCT02606058|Procedure|Deferred cord clamping|Deferred cord clamping (for 60 seconds or more with the baby held below or at the level of the placenta)
16038538|NCT02606045|Drug|recombinant von Willebrand factor|"Group I will receive Arm A recombinant von Willebrand factor 40 IU/kg intravenously (IV) infusion on day 1 of each of two menstrual cycles, Cycles 1 and 2. They will then be crossed over to Arm B, TA 650 mg 2 tablets orally (po) three times daily on days 1-5 of each of two menstrual cycles, Cycles 3 and 4.
~Group II will receive Arm B, TA 650 mg 2 tablets orally (po) three times daily on days 1-5, for each of two menstrual cycles, Cycles 1 and 2. They will then be crossed over to Arm A, rVWF 40 IU/kg intravenously (IV) infusion on day 1 on each of two menstrual cycles, Cycles 3 and 4."
16038539|NCT02606045|Drug|tranexamic acid|"Group I will receive Arm A recombinant von Willebrand factor 40 IU/kg intravenously (IV) infusion on day 1 of each of two menstrual cycles, Cycles 1 and 2. They will then be crossed over to Arm B, TA 650 mg 2 tablets orally (po) three times daily on days 1-5 of each of two menstrual cycles, Cycles 3 and 4.
~Group II will receive Arm B, TA 650 mg 2 tablets orally (po) three times daily on days 1-5, for each of two menstrual cycles, Cycles 1 and 2. They will then be crossed over to Arm A, rVWF 40 IU/kg intravenously (IV) infusion on day 1 on each of two menstrual cycles, Cycles 3 and 4."
16038540|NCT02606032|Drug|Metronidazole|active comparator
16038541|NCT02606032|Drug|Doxycycline|active comparator
16038545|NCT02606006|Behavioral|Standard of Care Physical Therapy|This intervention is the standard of care physical therapy currently offered. No canine is present.
16038546|NCT02605993|Biological|Ravulizumab|All treatments were given as IV infusions.
16038547|NCT02605980|Behavioral|Sedentary time|
16038548|NCT02605967|Drug|PDR001|PDR001 is a humanized anti-PD-1 IgG4 antibody which blocks the binding of PD1 to its ligands PD-L1 and PD-L2.
16038549|NCT02605967|Drug|Investigator choice of chemotherapy|commonly used chemotherapy as per investigator's choice
16038550|NCT02605954|Drug|E/C/F/TAF|150/150/200/10 mg FDC tablets administered orally once daily
16038551|NCT02605954|Drug|ABC/3TC|600/300 mg tablets administered orally once daily
16038552|NCT02605954|Drug|Third Antiretroviral Agent|"Third antiretroviral agents could include one of the following:
~ATV+cobicistat (COBI; Tybost®) or ATV/COBI FDC
~DRV+COBI or DRV/COBI FDC
~darunavir (DRV; Prezista®) + RTV
~lopinavir/ritonavir (LPV/r; Kaletra®)
~atazanavir (ATV; Reyataz®) + ritonavir (RTV; Norvir®)
~efavirenz (EFV; Sustiva®)
~etravirine (ETR; Intelence®)
~nevirapine (NVP; Viramune®)
~rilpivirine (RPV; Edurant®)
~dolutegravir (DTG; Tivicay®)
~raltegravir (RAL; Isentress®)
~fosamprenavir (FPV; Lexiva®) + RTV
~saquinavir (SQV; Invirase®) + RTV
~ATV (no booster)
~Drug classes:
~Protease inhibitors (PI): LPV/r, ATV, RTV, ATV, DRV, FPV and SQV
~Pharmacokinetic enhancer: COBI
~Non-nucleoside reverse transcriptase inhibitors (NNRTI): EFV, RPV, NVP, and ETR
~Integrase inhibitors: RAL and DTG"
16038553|NCT02605928|Device|Injeq Bioimpedance Probe (BIP) Needle|Injeq Bioimpedance Probe (BIP) Needle is an injection needle that has bioimpedance measurement capability. It consists of traditional needle cannulae and removable bioimpedance probe which enables the measurement of bioimpedance. The needle is connected to measurement device and tissue identifying algorithm. Bioimpedance is measured during the operation and the algorithm detects when the needle tip is in contact with synovial fluid.
16038554|NCT02605915|Drug|Atezolizumab|Atezolizumab 1200 milligrams (mg) or 840 mg (Cohort 1E only) flat dose administered via intravenous (IV) infusion on Day 1 of every 21-day cycle.
16038555|NCT02605915|Drug|Carboplatin|Carboplatin will be administered at an initial target of area under the curve (AUC) of 6 milligrams per milliliter*min (mg/mL*min) via an IV infusion on Day 1 of every 21-days for 6 cycles.
16038556|NCT02605915|Drug|Docetaxel|Docetaxel 75 mg/m^2 administered via IV infusion on Day 1 every 21-days for 6 cycles.
16038557|NCT02605915|Drug|Pertuzumab|Pertuzumab 840 mg loading dose then 420 mg administered via IV infusion on Day 1 of every 21-day cycle.
16038558|NCT02605915|Drug|Trastuzumab|Trastuzumab 8 milligram per kilogram (mg/kg) loading dose, then 6 mg/kg administered via IV infusion on Day 1 of every 21-day cycle.
16038559|NCT02605915|Drug|Trastuzumab emtansine|Trastuzumab emtansine 3.6 mg/kg administered via IV infusion on Day 1 of every 21-day cycle. Dose de-escalation may occur for trastuzumab emtansine, from the full trastuzumab emtansine dose at 3.6 mg/kg on Day 1 of every 21-day cycle, potentially to 3.0 mg/kg (Cohort 1C) or 2.4 mg/kg q3w (Cohort 1D).
16038560|NCT02605915|Drug|Doxorubicin|Doxorubicin will be administered at 60 mg/m^2 every 2 weeks as an IV bolus over 3 to 5 minutes or as an infusion over 15 to 30 minutes.
16038561|NCT02605915|Drug|Cyclophosphamide|Cyclophosphamide will be administered at 600 mg/m^2 on Day 1 of each 21 day cycle as an IV bolus over 3 to 5 minutes or as an infusion, in accordance with local policy.
16038562|NCT02605902|Behavioral|(i)Comprehensive Behavioral Intervention for Tics|
16038563|NCT02605902|Behavioral|internet-delivered psychoeducation and relaxation training|
16038564|NCT02605889|Other|Laser acupuncture|Laser acupuncture
16038565|NCT02605876|Device|Whole body vibration|
16038566|NCT02605876|Device|Local muscle vibration|
16038567|NCT02605863|Drug|Enzalutamide|160 mg by mouth daily for 12 months
16038568|NCT02605850|Other|Water|All subjects will consume ground beef patty meal with water at the baseline visit.
16038569|NCT02605850|Dietary Supplement|Pomegranate Juice|Pomegranate Juice will be taken 1/day for 4 weeks.
16038570|NCT02605850|Dietary Supplement|Pomegranate extract|Pomegranate extract will be taken 1/day for 4 weeks.
16038571|NCT02605837|Drug|Oral Budesonide Suspension (OBS)|Oral Budesonide Suspension (OBS) 10 milliliter (ml) of 0.2 milligram per milliliter (mg/ml) twice daily up to 16 weeks.
16038572|NCT02605837|Drug|Placebo|Oral dose of 10 ml of placebo matched with the experimental drug.
16038573|NCT02605824|Drug|n-acetylcystine|NAC is a mucolytic drug.
16038574|NCT02605824|Drug|0.9% saline|Normal saline is a placebo agent.
16038575|NCT02605811|Drug|temozolomide|
16038576|NCT02605811|Radiation|prophylaxis cranial radiotherapy|2
16038577|NCT02605798|Drug|Elbanovir|1 tablet contains 400 mg sofosbuvir
16038578|NCT02605798|Drug|Sovaldi|1 tablet contains 400 mg sofosbuvir
16038579|NCT02605798|Drug|Sovaldi|1 tablet contains 400 mg sofosbuvir
16038580|NCT02605785|Drug|F-18 AV 1451|Tau PET scan
16038581|NCT02605772|Drug|Acarbose|group1:metformin 1.5g + Saxagliptin 5mg group2:acarbose 300mg + Saxagliptin 5mg
16038582|NCT02605772|Drug|Metformin|group1:metformin 1.5g + Saxagliptin 5mg group2:acarbose 300mg + Saxagliptin 5mg
16038583|NCT02605772|Drug|Saxagliptin|group1:metformin 1.5g + Saxagliptin 5mg group2:acarbose 300mg + Saxagliptin 5mg
16038584|NCT02605759|Device|CryoBalloon Focal Ablation System|Positioned within the esophagus at the target location, the Balloon is simultaneously inflated and cooled with nitrous oxide. The nitrous oxide cools the inner Balloon surface. The Balloon remains stationary during the delivery of the nitrous oxide for the Cryoablation of Dysplastic Squamous Tissue in Patients with Esophageal Squamous Cell Dysplasia
16038585|NCT02605746|Drug|ceritinib 750mg|
16038586|NCT02605733|Device|EEG|amplitude integrated electroencephalography
16038587|NCT02605733|Device|NIRS|regional tissue oximetry
16038588|NCT02605720|Drug|Dihydroartemisinin-piperaquine|DHA/PPQ dose 2.1/17.1 mg/Kg daily for 3 days (PNG National Malaria Treatment Protocol) monthly for 3 months
16038589|NCT02605707|Drug|Intravenous stem cell transplantation|Intravenous injection of autologous endothelial progenitor cells transplantation
16038590|NCT02605694|Drug|Duvelisib|25 mg will be administered orally twice daily (BID) during 21-day cycles (Cycles 1-6) followed by 28-day cycles (Cycle 7 and beyond) until disease progression or unacceptable toxicity
16038591|NCT02605694|Drug|Rituximab|375 mg/m2 will be administered as an intravenous (IV) infusion on Day 1 of Cycles 1-6 (21-day cycles).
16038592|NCT02605694|Drug|R-CHOP|"IV infusion on Day 1 of Cycles 1-6 (21-day cycles)
~Cyclophosphamide (750 mg/m2)
~Doxorubicin hydrochloride (50 mg/m2)
~Vincristine sulfate (1.4 mg/m2) (2 mg maximum)
~Rituximab (375 mg/m2)"
16038593|NCT02605694|Drug|Prednisone|100 mg orally on Days 1-5 of Cycles 1-6 (21-day cycles)
16038594|NCT02605668|Behavioral|Intensified psychological intervention|12 sessions of Cognitive Behavioral Therapy a 100 minutes, over the course of 6 weeks (2 sessions per week/week 1 and 2, 3 sessions per week/week 3 und 4, 1 session per week/week 5 and 6)
16038595|NCT02605668|Behavioral|Standard intervention|12 sessions of Cognitive Behavioral Therapy a 100 minutes, over the course of 10 weeks (2 sessions per week/week 1 and 2, 1 session per week/week 3 to 10)
16038596|NCT02605655|Drug|AMP-1915|A traditional Chinese Formula extract from Astragalus, Radix Puerariae and Cortex Mori is mixed into instant noodles. Patients are treated with AMP-1915 as meal.
16038597|NCT02605655|Other|Placebo|Instant noodles without drug
16038598|NCT02605642|Drug|CT-P13|biosimilar infliximab
16038599|NCT02605629|Other|CG428|The experimental group will receive CG428. For each application, the patient should shake the bottle before spraying 10-12 times directly to the dry scalp whole area, with the nozzle, and then gently massage the whole scalp with fingertips in order to spread the lotion evenly until it has completely penetrated the scalp. Hairs should not be washed or shampooed within 1 hour following study treatment administration. Each dose should be spaced out by minimum 4 hours.
16038600|NCT02605629|Other|Placebo|The placebo group will received placebo which excluded active ingredients. For each application, the patient should shake the bottle before spraying 10-12 times directly to the dry scalp whole area, with the nozzle, and then gently massage the whole scalp with fingertips in order to spread the lotion evenly until it has completely penetrated the scalp. Hairs should not be washed or shampooed within 1 hour following study treatment administration. Each dose should be spaced out by minimum 4 hours.
16038601|NCT02605616|Drug|AZ compound|AZ compound 800 mg/day for 12 weeks (plus or minus 1 week) in two divided doses morning (400 mg) and evening (400 mg).
16038602|NCT02605616|Other|Placebo|Placebo 800 mg/day for 12 weeks (plus or minus 1 week) in two divided doses morning (400 mg) and evening (400 mg).
16038603|NCT02605590|Drug|AIR DNase|
16038604|NCT02605590|Drug|Placebo|
16038605|NCT02605577|Procedure|new systemic nutrition management protocol|a new established systemic nutrition management protocol
16038608|NCT02605551|Procedure|Osteopathic Manipulative Therapy|"All OMT techniques will be performed by osteopathic physicians who will have received training specific to this protocol prior to study initiation. All used techniques will be slow moving and gentle to augment rest and relaxation, promote autonomic balance, and release fascial contractures. The techniques that will be used in this protocol are:
~OM Occipitomastoid release technique
~Sub-Occipital Release Technique
~Rib Raising Technique
~Rotatory stimulation of posterior Chapman's Reflexes
~Lymphatic Pumps and Effleurage: (Pedal Pump of Dalrymple)"
16038609|NCT02605551|Behavioral|Lifestyle Modification|Patients will be counseled on healthy behaviors such as regular exercise, weight loss, and a healthy diet
16038610|NCT02605538|Biological|Vaccination with vaccine against hepatitis A and B|Vaccination against hepatitis A and B
16038611|NCT02605525|Biological|SM101|Human soluble recombinant Fcγ Receptor IIB
16038612|NCT02605525|Other|Placebo|L-histidine-buffered saline with mannitol, sucrose, and polysorbate 20
16038613|NCT02605512|Other|Subclinical cardiac lesions and biomarkers|Functional myocardial dysfunction based on 2D-speckle tracking echocardiography, Anatomical coronary lesions based on Coronary computed tomography angiography, a panel of circulating biomarkers based on blood samples and plasma
16038614|NCT02605499|Other|UV-C light disinfection|UV-C light disinfection will be used in hospital patient rooms as an adjunct to routine daily and discharge cleaning.
16038615|NCT02605486|Drug|Palbociclib|
16038616|NCT02605486|Drug|Bicalutamide|
16038617|NCT02605460|Drug|Busulfan|12mg/kg, Oral, divided in 4 days, 3mg/kg/day Oral, during days -7, -6, -5 y -4.
16038618|NCT02605460|Drug|Cyclophosphamide|80mg/kg, Intravenous (IV), divided in 2 days, 40mg/kg/day IV, during days -3 y -2.
16038619|NCT02605460|Drug|CXCR4 Antagonist|24mg, Subcutaneous (SC), in one day, 24mg/day SC, during day -4.
16038620|NCT02605460|Procedure|Hematopoietic Stem Cell Transplantation|Peripheral blood HSC (autologous HSCT) or Bone Marrow HSC (allogeneic HSCT) transfusion, day 0
16038621|NCT02605447|Drug|3 months of dual antiplatelet therapy (DAPT)|3 months of P2Y12 inhibitor (clopidogrel, prasugrel or ticagrelor) plus 15-months of aspirin
16038622|NCT02605447|Device|SYNERGY Stent System|SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System
16038623|NCT02605434|Drug|Accordion Pill™ Carbidopa/Levodopa|AP-CD/LD capsule containing 50 mg carbidopa with 400 mg or 500 mg levodopa administered orally twice or 3 times a day
16038624|NCT02605434|Drug|Sinemet®|Sinemet® tables containing carbidopa and levodopa 25/100 mg will be administered orally at least 4 times a day according to patients need
16038625|NCT02605434|Drug|Placebo -AP-CD/LD|Placebo for AP-CD/LD capsule
16038626|NCT02605434|Drug|Placebo- Sinemet|Placebo for Sinemet tables
16038627|NCT02605421|Drug|Thiotepa|Thiotepa by IV once daily for 3 doses on Days -7, -6 and -5. Given as part of Consolidation Course #1 along with Cyclophosphamide.
16038628|NCT02605421|Drug|Cyclophosphamide|Cyclophosphamide by IV once daily for 4 doses on Days -5, -4, -3 and -2. Given as part of Consolidation Course #1 along with Thiotepa.
16038629|NCT02605421|Drug|Melphalan|Melphalan by IV once daily for 3 doses on Days -8, -7, and -6. Given as part of Consolidation Course #2 along with Etoposide and Carboplatin.
16038630|NCT02605421|Drug|Etoposide|Etoposide by IV once daily for 4 doses on Days -8, -7, -6 and -5. Given as part of Consolidation Course #2 along with Melphalan and Carboplatin.
16038631|NCT02605421|Drug|Carboplatin|Carboplatin by IV once daily for 4 doses on Days -8, -7, -6 and -5. Given as part of Consolidation Course #2 along with Etoposide and Melphalan.
16038632|NCT02605421|Biological|Autologous Stem Cell Infusion|On Day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines.
16038633|NCT02605421|Biological|Granulocyte colony stimulating factor|Beginning on day 0 after infusion of the PBSC, patients will receive G-CSF SQ or IV (SQ preferred) 5 micrograms/kg once daily and continuing once daily until post-nadir ANC > 2000/μL for 3 consecutive days.
16038634|NCT02605408|Device|LenSx® laser system|Femtosecond laser system used for cornea incision, capsulotomy and lens fragmentation during cataract surgery
16038635|NCT02605408|Procedure|Phacoemulsification|Removal of the cataractous lens
16038636|NCT02605395|Drug|IDIAZOLE 20mg DR tabs|IDIAZOLE 20mg DR tabs is a delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium.
16038637|NCT02605395|Drug|PARIET 20 mg DR tabs|PARIET 20 mg DR tabs is a delayed-release, enteric-coated tablets containing 20 mg rabeprazole sodium.
16038638|NCT02605382|Drug|Chlorhexidine gluconate|
16038639|NCT02605382|Drug|placebo|Solution chemical manufactured to mimic 0.12% chlorhexidine mouthwash
16038640|NCT02605369|Behavioral|Intervention arm: An integrated package|See description in previous column
16038641|NCT02605356|Drug|Radium-223 dichloride (Xofigo, BAY88-8223)|
16038642|NCT02605356|Drug|Placebo|
16038643|NCT02605356|Drug|Bortezomib|
16038644|NCT02605356|Drug|Dexamethasone|
16038645|NCT02605343|Other|NeuroIDgenetix Test Panel|The NeuroIDgenetix Test Panel is used to make recommendations on post-operative pain medication therapy that may be impacted by the genetic background of the patient.
16038646|NCT02605330|Procedure|Fibrinogen plasma level|At 12 different time points investigators plan to measure the plasma fibrinogen level with conventional coagulation tests (Clauss fibrinogen) and with ROTEM.
16038647|NCT02605317|Other|WhatsApp|Consultations used WhatsApp Messenger
16038648|NCT02605304|Drug|Ledipasvir/sofosbuvir|Participants were prescribed one fixed dose tablet of LDV 90 mg/SOF 400 mg orally per day.
16038649|NCT02605304|Drug|Ribavirin|"Based on weight at entry:
~For weight <75 kg, participants were prescribed 1000 mg of RBV per day, divided into two doses to be taken orally.
~For weight ≥75 kg: participants were prescribed 1200 mg of RBV per day, divided into two doses to be taken orally."
16038650|NCT02605291|Other|Diet with a different macronutrient content A|A diet with altered macronutrient content will be provided to participants on days 4-6 of experimental arm 1.
16038651|NCT02605291|Other|Diet with a different macronutrient content B|A diet with a different macronutrient content compared to arm 1 will be provided to participants on days 4-6 of experimental arm 2.
16038652|NCT02605291|Other|Diet with a different macronutrient content C|A diet with a different macronutrient content compared to arms 1 and 2 will be provided to participants on days 4-6 of experimental arm 3.
16038653|NCT02605291|Other|Interval treadmill running exercise|Participants will perform interval treadmill running exercise on days 4 and 5 of all experimental arms.
16038654|NCT02605291|Other|Steady state treadmill running exercise|Participants will perform steady state treadmill running exercise on day 7 of all experimental arms.
16038655|NCT02605278|Other|Clinical program for pain and depression|Already described
16038656|NCT02605278|Other|Control|Care as usual
16038657|NCT02605265|Radiation|Radiation|Pelvic Radiation: 50Gy/25Fx
16038658|NCT02605265|Drug|Capecitabine|
16038659|NCT02605265|Drug|Irinotecan|
16038660|NCT02605265|Drug|Oxaliplatin|
16038661|NCT02605252|Drug|Peginterferon alfa-2b|peginterferon alfa-2b 80 micrograms/week for 48 weeks
16038662|NCT02605239|Drug|Bleaching teeth|bleaching teeth with carbamide peroxide 10% for 3 weeks
16038663|NCT02605226|Procedure|Cryoablation therapy|Cryoablation therapy
16038664|NCT02605226|Radiation|External beam radiation therapy|External beam radiation therapy
16038665|NCT02605226|Drug|bicalutamide|bicalutamide
16038666|NCT02605226|Drug|luteinizing-hormone releasing-hormone (LHRH) agonist|luteinizing-hormone releasing-hormone (LHRH) agonist
16038667|NCT02605213|Drug|Vancomycin|Vancomycin for treatment of primary sclerosing cholangitis
16038668|NCT02605213|Drug|Placebo|Placebo for control Group of primary sclerosing vhlangitis
16038669|NCT02605200|Behavioral|Psychologist Support|Participants will complete several psychological questionnaires that are intended to cover a broad spectrum of physical, mental, and emotional aspects of the health of participants; the Behavior Assessment System for Children (BASC) ,the Children Depression Inventory (CDI 2), the Pediatric Quality of Life Inventory Transplant Module (PedsQL), and the Wechsler Abbreviated Scale of Intelligence II (WASI-II). Data gathered from this testing will be used to guide the provision of psychological care to address psychosocial challenges inherent to the care of children with transplant related diabetes.
16038670|NCT02605200|Behavioral|Pediatric Certified Diabetes Educators (CDEs) Support|Pediatric Certified Diabetes Educators (CDEs) are specially trained to teach diabetes self-management to children and their families. Participants who are diagnosed with diabetes will receive individualized support from a CDE in conjunction with their routine transplant care.
16038671|NCT02605187|Other|No choice given|Patients are randomized to getting a choice or not getting a choice. If they do not get a choice, they receive standard dose.
16038672|NCT02605187|Other|Choice given|Patients are randomized to getting a choice or not getting a choice. If they do get a choice, they will receive the protocol they select.
16038673|NCT02605187|Drug|Ibuprofen|Ibuprofen 600mg po q6h
16038674|NCT02605187|Drug|Acetaminophen|Acetaminophen 650mg po q6h
16038675|NCT02605187|Drug|Gabapentin|Gabapentin 600mg po one time within 1 hour of delivery
16038676|NCT02605187|Drug|Morphine (low)|Intrathecal morphine dose 50mcg
16038677|NCT02605187|Drug|Morphine (med)|Intrathecal morphine dose 150mcg
16038678|NCT02605187|Drug|Morphine (high)|Intrathecal morphine 300mcg
16038679|NCT02605174|Drug|Lasmiditan 50 mg|One tablet lasmiditan 50 mg plus one placebo tablet (matching one of the lasmiditan doses)
16038680|NCT02605174|Drug|Lasmiditan 100 mg|One tablet lasmiditan 100 mg plus one placebo tablet (matching one of the lasmiditan doses)
16038681|NCT02605174|Drug|Lasmiditan 200 mg|One tablet lasmiditan 200 mg plus one placebo tablet (matching one of the lasmiditan doses)
16038682|NCT02605174|Drug|Placebo|Two placebo tablets to match lasmiditan doses.
16038689|NCT02605122|Drug|Standard of Care|Age- and weight-based dosing as appropriate per sites standard of care.
16038690|NCT02605109|Other|Risk of MERS infection|HCPs, patients and layperson to closely or indirectly contact a case-patients
16038691|NCT02605096|Procedure|MRI|Magnetic Resonance Imaging Scan
16038692|NCT02605096|Procedure|X-ray|X-ray exam (conventional radiography)
16038693|NCT02605083|Drug|eFT508|Will be given orally once or twice daily. Each treatment cycle = 21 days.
16038694|NCT02605070|Drug|Bravelle|"Bravelle will be provided to all patients in the treatment group by the principal investigator (PI) or another member of the research team.
~From week nine on, the patients will undergo a physical examination on three different occasions to assess the appearance of any adverse reactions during treatment. It will be up to the patient to communicate the appearance of signs or symptoms which could be associated with the use of the drug.
~At week 12 the patient will be scheduled for another visit to perform a semen study and to measure new hormone levels. To this end, a blood test will be carried out (FSH, LH, estradiol, total testosterone, SHBG, and albumin to calculate the amount of bioavailable testosterone). A semen sample will also be obtained to carry out a spermiogram according to WHO guidelines; part of this sample will be used for epigenetic analysis."
16038695|NCT02605057|Drug|LEO 80185 gel|
16038696|NCT02605057|Drug|Dovobet(r) Ointment|
16038697|NCT02605044|Drug|Masitinib (AB1010)|
16038698|NCT02605044|Drug|FOLFIRI|
16038699|NCT02604992|Drug|Treatment A|Dronabinol oral solution, under fed conditions
16038700|NCT02604992|Drug|Treatment B|Dronabinol oral capsule, under fed conditions
16038701|NCT02604992|Drug|Treatment C|Dronabinol oral capsule, under fasted conditions
16038702|NCT02604966|Drug|Artesunate (AS) group|Oral treatment with AS at 4mg/kg/day for 3 days followed by three days of DHA - PPQ in order to insure total parasite clearance. Randomization is done by blocks of ten.
16038703|NCT02604966|Drug|DHA - PPQ group|Oral treatment with 3-day course of DHA - PPQ. Randomization is done by blocks of ten.
16038704|NCT02604953|Diagnostic Test|Short Duration Transient Visual Evoked Potential (SDtVEP)|Short duration transient visual evoked potentials (VEPs) detect disruption of electrical signals at any point along the visual pathway, from the retinal ganglion cells (RGCs) to the primary visual cortex. As an objective measure of visual function, VEP may have advantage over traditional visual field tests, by reducing confounded factors such as age, fatigue, and mental status.
16038705|NCT02604953|Diagnostic Test|Pattern electroretinogram (PERG)|Pattern electroretinogram (PERG), an objective test, is used for evaluating early damage to retinal ganglion cells (RGC). In PERG, retinal response is recorded while patterns are viewed in the visual field on a computer monitor.
16038706|NCT02604940|Drug|Dexmedetomidine|1mcg/kg IV dexmedetomidine over 10 minutes from 60ml syringe in OR upon notification of surgical closure
16038707|NCT02604940|Drug|Normal Saline|60ml Saline delivered over 10 minutes in OR upon notification of surgical closure.
16038708|NCT02604927|Dietary Supplement|Beta-alanine|
16038709|NCT02604927|Dietary Supplement|Dextrose|
16038710|NCT02604914|Drug|ND0612|Subcutaneous solution
16038711|NCT02604914|Drug|LCIG|Intrajejunal Gel
16038712|NCT02604901|Behavioral|Screening and Brief Intervention (BI)|Rite Aid® pharmacists screened patients at the time of the initial fill with the Adherence Estimator™ and using the screening results, provided the behavioral intervention, Brief Intervention using motivational interviewing principles based on POLAR*S (BI). BI was considered an active intervention method.
16038713|NCT02604901|Behavioral|Pill Box (PB)|Rite Aid® pharmacists provided patients with a Pill Box (PB) and information about their medications. However, pharmacists did not use motivational interviewing principles for engaging patients in direct interventions to modify behavior. PB was considered a passive intervention method.
16038714|NCT02604888|Other|MEXIS/M6S Patent - lotion against alopecia|For greatest problems 20 drops on the scalp per day for 6 months. For minor problems 10 drops on the scalp three times per week for 6 months.
16038715|NCT02604875|Other|observation|blood sampling during 24 hours
16038716|NCT02604862|Other|FIB ONE|FIB ONE will be administered to each patient during a bronchoscopy procedure. Fibre-based endomicroscopy and two types of viewer software will be used to detect FIB ONE signal in the lung.
16038717|NCT02604862|Other|AZD1236|AZD1236 will be delivered at microdose concentrations and is thus considered to be unable to exert any pharmacologic effect outside the area of administration and unlikely to cause an adverse reaction.
16038718|NCT02604849|Drug|Neomycin|
16038719|NCT02604849|Drug|Streptomycin|
16038720|NCT02604849|Drug|Gentamicins|
16038721|NCT02604836|Drug|Ibandronate|Film-coated oral ibandronate tablet (150 mg) once-monthly
16038722|NCT02604823|Drug|Peginterferon alfa-2a|Peginterferon alfa-2a will be administered at a dose of 180 mcg subcutaneously once weekly for 48 weeks.
16038723|NCT02604810|Biological|IGIV-C 10%|IGIV-C 10% infusions every 3 to 4 weeks based on previous IgG regimen
16038724|NCT02604810|Biological|IGSC 20%|IGSC 20% weekly infusions with dose calculated based on previous IgG regimen
16038725|NCT02604797|Drug|Nalbuphine|patient-controlled intravenous analgesia
16038726|NCT02604797|Drug|Sufentanil|patient-controlled intravenous analgesia
16038727|NCT02604797|Drug|flurbiprofen axetil|patient-controlled intravenous analgesia
16038728|NCT02604797|Drug|ramosetron|patient-controlled intravenous analgesia
16038729|NCT02604784|Drug|Pressurized IntraPeritoneal Air-flow Chemotherapy (PIPAC) fixed repeated dose|An open access with a midline 5-6 cm incision is performed and a single-port platform is positioned. A 12 mm Hg CO2 pneumoperitoneum is inflated. PC extent is evaluated according to Peritoneal Cancer Index (PCI) and peritoneal biopsies are taken. A nebulizer is connected to an intravenous high-pressure injector and inserted into the peritoneal cavity; the tightness of the abdomen has to be documented with a CO2 zero-flow. The laparoscopic camera and the nebulizer are maintained in position by a self-retaining retractor (Thompson). A pressurized aerosol containing drugs is delivered. Standard dosage of drugs for each PIPAC: Cisplatin (7.5 mg/m²) + Doxorubicin (1.5 mg/m²) or Oxaliplatin (92 mg/m²) The capnoperitoneum is then maintained for 30 minutes at 37°C. At the end, the aerosol is exsufflated through two sequential micro-particle filters into the air-waste system of the hospital.
16038758|NCT02604576|Drug|FDC Bromopride 10 mg and Simethicone 80 mg|Fixed-dose combination of Bromopride 10 mg and Simethicone 80 mg
16038730|NCT02604784|Drug|Pressurized IntraPeritoneal Air-flow Chemotherapy (PIPAC) increasing single dose|An open access with a midline 5-6 cm incision is performed and a single-port platform is positioned. A 12 mm Hg CO2 pneumoperitoneum is inflated. PC extent is evaluated according to Peritoneal Cancer Index (PCI) and peritoneal biopsies are taken. A nebulizer is connected to an intravenous high-pressure injector and inserted into the peritoneal cavity; the tightness of the abdomen has to be documented with a CO2 zero-flow. The laparoscopic camera and the nebulizer are maintained in position by a self-retaining retractor (Thompson). A pressurized aerosol containing drugs is delivered. Escalating dosage of drugs for PIPAC: Cisplatin + Doxorubicin (from 15 mg/m² + 3 mg/m² to 100 mg/m² + 30 mg/m²) or Oxaliplatin (from 92 mg/m² to 300mg/m²).The capnoperitoneum is then maintained for 30 minutes at 37°C. At the end, the aerosol is exsufflated through two sequential micro-particle filters.
16038731|NCT02604758|Behavioral|The Psychiatric Nursing Approach Based On The Tidal Model|To provide individualized care for patients in the experimental group, the One-to-One Sessions were initiated and interventions were performed in line with the goals of the persons and the aims of the research. The interventions were selected from interventions regarding with coping and self-esteem from the Nursing Interventions Classification(NIC) system.The One-to-One sessions help the person recognize change and focus the person on achievement and goals.Taking into account the basic process of the Tidal Model, care stages, the following interview plan was drawn up, containing the details of the interviews to be carried out with people with alcohol dependency, and the One-to-One Sessions were held in line with this plan two times per week.
16038732|NCT02604732|Procedure|Laparoscopic inguinal hernia repair|
16038733|NCT02604719|Drug|Tranexamic Acid and Ethamsylate|The intervention will be the intravenous administration of 10 ml blinded vial of the study drugs (either 1 gmTranexamic acid and 1 gm Ethamsylate or placebo according to randomization group) slowly (over 30-60 sec ) in the 2 minutes after birth and the routine prophylactic oxytocin and after the cord has been clamped , all generally by the anesthesiologist or obstetrician then a pad will be placed under women buttocks then weighting the pads to allow objective measurement of blood loss.
16038734|NCT02604706|Device|NADA Acupuncture|NADA-acupuncture was delivered in three phases: (1) one treatment each day during the first of a total of five weeks; (2) three treatments each week during the following two weeks; (3) two treatments each week during the two remaining weeks. each session consisted of approximately 40 minutes with acupuncture at five ear points called Sympathetic, Shen Men, Kidney, Liver and Lung, which are believed to be the best points for substance abuse patients. Acupuncture was administered to both ears using stainless steel needles. NADA-acupuncture were given as a supplement to treatment as usual consisting of Motivational Interview, pharmacological treatment, and control of drug use with urine tests.
16038735|NCT02604706|Device|LP acupuncture|The LP-acupuncture was delivered in two phases: (1) three treatments each week during the two first weeks; (2) two treatments each week for two weeks. each session consisted of approximately 40 minutes with acupuncture at five ear points called Sympathetic, Shen Men, Kidney, Liver and Lung, which are believed to be the best points for substance abuse patients. Acupuncture was administered to both ears using stainless steel needles. LP-acupuncture were given as a supplement to treatment as usual consisting of Motivational Interview, pharmacological treatment, and control of drug use with urine tests.
16038736|NCT02604706|Behavioral|Relaxation|Relaxation consisted of listening to soft music in a quiet room with dampened light and was delivered to match the amount and phases of the LP-acupuncture. Relaxation were given as a supplement to treatment as usual consisting of Motivational Interview, pharmacological treatment, and control of drug use with urine tests.
16038737|NCT02604693|Other|Nothing|No interventions will be administered.
16038738|NCT02604680|Drug|BLI1100-1|BLI1100-1 Topical gel
16038739|NCT02604680|Drug|BLI1100-2|BLI1100-2 Topical gel
16038740|NCT02604680|Drug|BLI1100-3|BLI1100-3 Topical gel
16038741|NCT02604680|Drug|BLI1100-4|BLI1100-4 Topical gel
16038742|NCT02604680|Drug|Placebo|Placebo - Topical gel
16038743|NCT02604667|Other|Blood tests|"Study participants will undergo a single, peripheral blood draw. Blood specimens will be used to perform hematological biomarker testing and leukocyte RNA gene expression analysis.
~Hematological biomarker testing will be performed to better elucidate the mechanisms of ischemic stroke in cancer patients and will include markers of coagulation, platelet function, and endothelial integrity. This analysis will occur at MSKCC.
~Leukocyte RNA gene expression analysis will be performed to evaluate whether patients with cancer and stroke more often have cardioembolic mechanisms than patients with stroke and no cancer. This analysis will occur at the University of California, Davis where investigators have previously shown that differential RNA expression patterns can predict stroke subtypes."
16038744|NCT02604667|Other|Transcranial Doppler Microemboli Detection Study|Study participants will undergo a single Transcranial Doppler Microemboli Detection Study at NYPH/WCMC or MSKCC within two weeks of enrollment. Both middle cerebral arteries will be insonated for 30 minutes by a trained technician or stroke neurologist certified in neurosonology using a fixed headset to assess for the rate and laterality of microemboli.
16038745|NCT02604654|Drug|Yiqitongluo granule|administered after dissolved
16038746|NCT02604641|Dietary Supplement|Placebo group|Subjects will take 5 mL of placebo syrup (0 mg CoQ10/day) once per day for 12 weeks.
16038747|NCT02604641|Dietary Supplement|Quvital LD group|Subjects will take 5 mL of LD syrup (50 mg CoQ10/day) once per day for 12 weeks.
16038748|NCT02604641|Dietary Supplement|Quvital HD group|Subjects will take 5 mL of LD syrup (150 mg CoQ10/day) once per day for 12 weeks.
16038749|NCT02604628|Behavioral|Antibiotic Stewardship Intervention|The Antibiotic Stewardship Intervention will consist of education, motivating opinion leaders, adapting a pragmatic disease severity classification and prospective audit and feedback.
16038750|NCT02604615|Drug|Capecitabine(Aibin)|capecitabine(Aibin):625mg/m2,bid d1-5; q1w, po,5 or 10 weeks in total
16038751|NCT02604615|Drug|Oxaliplatin(Aiheng)|Oxaliplatin(Aiheng):65mg/m2,d1,8,22,29,I.V. or Oxaliplatin(Aiheng):65mg/m2,d1,8,22,29,43,50,64,71,I.V.
16038752|NCT02604615|Radiation|Radiotherapy|concurrent radiotherapy:50Gy in total,2 Gy/d,5d/w,Until disease progression or unacceptable toxicity
16038753|NCT02604602|Other|blood exam|laboratory test
16038754|NCT02604589|Drug|hydromorphone hydrochloride|Patient-controlled narcotic analgesia pump
16038755|NCT02604589|Procedure|Infusion catheter placement|Placement of continuous infusion catheter and elastomeric pump into extrathoracic paraspinous space
16038756|NCT02604589|Drug|bupivicaine 0.25%|Low Dose analgesia
16038760|NCT02604563|Other|Cognitive Assessment|-Baseline and no more frequently than every 6 months until death
16038761|NCT02604563|Other|Activities of Daily Living Questionnaire|"10 items about daily functional status
~Baseline and no more frequently than every 6 months until death"
16038762|NCT02604563|Other|Instrumental Activities of Daily Living, subscale of the OARS|"7 items about daily functional status
~Baseline and no more frequently than every 6 months until death"
16038763|NCT02604563|Other|Karnofsky Self-reported Performance Rating Scale|"1 item about daily functional status
~Baseline and no more frequently than every 6 months until death"
16038764|NCT02604563|Other|Number of Falls|"1 item about daily functional status
~Baseline and no more frequently than every 6 months until death"
16038765|NCT02604563|Other|Physical Health Section, subscale of the OARS|"13 items about comorbidity
~Baseline and no more frequently than every 6 months until death"
16038766|NCT02604563|Other|MOS Social Activity Survey|"4 items about social activity
~Baseline and no more frequently than every 6 months until death"
16038767|NCT02604563|Other|Unintentional Weight Loss|"2 items about nutrition
~Baseline and no more frequently than every 6 months until death"
16038768|NCT02604563|Genetic|Peripheral Blood Draw|-Baseline and no more frequently than every 6 months until death
16038769|NCT02604563|Genetic|Buccal Swab|"Participants will rinse their mouths 2 times with water for 20-30 seconds and discard the expectorated sample. One side of the inner cheek (buccal mucosa) will then be scraped with a cotton swab 20 times (alternatively, the tongue will be brushed 20 times with a toothbrush)
~Baseline and no more frequently than every 6 months until death"
16038770|NCT02604563|Other|Heart Health and Smoking History from BRFSS questionnaire|"7 items about heart health and smoking history
~Baseline and no more frequently than every 6 months until death"
16038771|NCT02604563|Other|Gait Speed|"Research coordinator will test gait speed
~Baseline and no more frequently than every 6 months until death"
16038772|NCT02604563|Other|Grip Strength|"Research coordinator will test grip strength
~Baseline and no more frequently than every 6 months until death"
16038773|NCT02604563|Other|Height and Weight measurements|-Baseline and no more frequently than every 6 months until death
16038774|NCT02604563|Other|Blood pressure measurement|-Baseline and no more frequently than every 6 months until death
16038775|NCT02604563|Procedure|Optional bone marrow biopsy|-1 optional bone marrow biopsy
16038776|NCT02604563|Procedure|Blood draw for trauma measurements|-For Arm E only
16038777|NCT02604550|Drug|Ropivacaine 0.5%|Ropivacaine 0.5% will be administered to the femoral nerve or adductor canal.
16038778|NCT02604550|Drug|Percocet 7.5/325|Percocet 7.5/325 will taken as needed up to every four hours.
16038779|NCT02604550|Drug|Naprosyn 500 mg|Naprosyn 500 mg will be taken twice daily.
16038780|NCT02604537|Drug|betamethasone|1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 6 mg/ml betamethasone
16038781|NCT02604537|Drug|Ketorolac|1 cc of 1% lidocaine (without epinephrine) plus 1 cc of 30 mg/ml of ketorolac
16038782|NCT02604524|Device|Closed-Loop Control|Subjects will use the CLC during 5 nights/6 days at a ski camp.
16038783|NCT02604524|Other|Sensor Augmented Pump Therapy|Subjects using their personal pumps with study CGM.
16038784|NCT02604511|Drug|Ibrutinib|
16038785|NCT02604498|Drug|Nemonoxacin|Single dose 500mg oral
16038786|NCT02604485|Drug|Cohort 1|XOMA 358 single dose level A administered by an intravenous infusion
16038787|NCT02604485|Drug|Cohort 2|XOMA 358 single dose level B administered by an intravenous infusion
16038788|NCT02604485|Drug|Cohort 3|XOMA 358 single dose level C administered by an intravenous infusion
16038789|NCT02604485|Drug|Cohort 4|XOMA 358 single dose level D administered by an intravenous infusion
16038790|NCT02604472|Other|CCRT|Locoregionally advanced nasopharyngeal carcinoma patients received platinum-based/non-platinum based concurrent chemoradiotherapy.
16038791|NCT02604472|Other|IC+CCRT|Locoregionally advanced nasopharyngeal carcinoma patients received induction chemotherapy and platinum-based/non-platinum based concurrent chemoradiotherapy.
16038792|NCT02604459|Device|cerebral oximeter (Fore-Sight)|The cerebral oximeter will be monitored in the optimized care group and cerebral oxygenation will be maintained at 60% or higher.
16038793|NCT02604459|Device|depth of anesthesia monitor (BIS)|The depth of anesthesia will be maintained between 40 and 60 in the optimized care group.
16038794|NCT02604459|Procedure|BP management|The systolic blood pressure will be maintained within 20% of preoperative levels in the optimized care group.
16038795|NCT02604459|Procedure|General anesthesia|General anesthesia will be used in both groups
16038796|NCT02604459|Drug|propofol|propofol per protocol
16038797|NCT02604459|Drug|fentanyl|fentanyl per protocol
16038798|NCT02604459|Drug|sevoflurane|maintenance of anesthesia with inhaled sevoflurane
16038799|NCT02604446|Drug|Tapentadol|
16038800|NCT02604446|Drug|Oxycodone|
16038801|NCT02604446|Drug|Placebo|
16038802|NCT02604446|Drug|usual pain treatment|premedication of Dexamethasone, Paracetamol, Vimovo; postoperative Paracetamol and Vimovo
16038803|NCT02604433|Drug|Luspatercept|Subjects will start with luspatercept at 1 mg/kg dose level.
16038804|NCT02604433|Other|Placebo|Placebo, Subcutaneous, every 21 days.
16038805|NCT02604420|Drug|eculizumab|
16038806|NCT02604407|Drug|SHP465 12.5mg capsules (one capsule daily)|one capsule daily
16038807|NCT02604407|Other|Placebo|Matching placebo capsule that appears identical in size, weight, shape, and color (one capsule daily)
16038808|NCT02604407|Drug|SHP465 12.5mg, 25mg, or 37.5mg capsules (one capsule daily)|One capsule daily
16038809|NCT02604394|Procedure|Rheolytic Thrombectomy|"RT will be performed with the The AngioJet rheolytic thrombectomy system (Medrad Interventional/Possis, Minneapolis, Minnesota).
~The RT system includes three units: disposable catheter, disposable pump set and a reusable drive unit:
~The single-use catheter has two lumens; one allows for the in-flow of high velocity saline jets through the catheter tip, and the other allows for the evacuation of thrombotic debris and passage of a guidewire.
~The disposable pump connects to a bag of heparinized saline.
~The drive unit pumps pressurized heparinized saline at 10,000 psi at the tip of the catheter,"
16038838|NCT02604212|Drug|entecavir|All participants will take entecavir or tenofovir throughout the study. Participants will be instructed to take their medication daily.
16038810|NCT02604394|Procedure|Conventional PCI|In patients in the conventional PCI group, antegrade flow in the culprit vessel will be established with conventional PCI with preference of direct stenting and use of manual thrombus aspiration when deemed necessary by the operator.
16038811|NCT02604381|Dietary Supplement|Glucosamine Sulfate Potassium Chloride/Standardized Ginkgo Biloba Extract|
16038812|NCT02604381|Other|Placebo|
16038813|NCT02604368|Drug|SC411|Soft gelatin capsule
16038814|NCT02604368|Drug|Placebo|Soft gelatin capsule
16038815|NCT02604355|Other|Matching Placebo|Oral dosing with placebo capsules to match RO7020322.
16038816|NCT02604355|Drug|RO7020322|Adaptive oral dosing with RO7020322 capsules, starting at 1 mg daily, with ascending or adjusted dosing based on the results of previous dosing.
16038817|NCT02604342|Drug|Alectinib|Participants will receive oral alectinib at a dose of 600 mg twice daily, taken with food until disease progression, unacceptable toxicity, withdrawal of consent or death.
16038818|NCT02604342|Drug|Docetaxel|Participants will receive docetaxel at a dose of 75 mg/m^2 of body surface area intravenously every 3 weeks, until disease progression, unacceptable toxicity, withdrawal of consent or death.
16038819|NCT02604342|Drug|Pemetrexed|Participants will receive pemetrexed at a dose of 500 mg/m^2 of body surface area intravenously every 3 weeks, until disease progression, unacceptable toxicity, withdrawal of consent or death.
16038820|NCT02604329|Device|"Oncolase Digi therapy laser diode"|"The athermic phototherapy laser diode will be used by scanning the entire oral mucosa, including cheek and lip mucosa, gums, palate, tongue and floor of the mouth. It will be applied uniformly every two days as long as the grade of mucositis is 2 or more, with a fluence of 4J/cm², under two wavelengths (635 nm and 815 nm).
~Cheeks will be scanned extra-orally with laser fiber during 50 seconds, at the fluence of 4J/cm², associating two wavelengths : infra-red (815 nm, 3850mW) and red (635 nm, 150mW).
~Intra-orally, the fiber will be used to scan each area of mucositis during 30 seconds per area of 2 cm2, at 1cm from the mucosa; the power at 635 nm will be 150 milliwatts and 150 milliwatts at 815 nm."
16038821|NCT02604316|Other|Arabinoxylan|10 days of weight loss diet calculated as 100% RMR + 15g Arabinoxylan (Medium Chain Naxus, BioActor b.v., Netherlands) per day in incremental dose 25% according energy requirement, 30% protein, 30% fat, 40% carbohydrate.
16038822|NCT02604316|Other|Beta- Glucan|10 days of weight loss diet calculated as 100% RMR + 6g β-glucan (Viscofibre, Naturex SA, France) per day in incremental dose 25% according energy requirement, 30% protein, 30% fat, 40%
16038823|NCT02604303|Other|No Intervention|No intervention; prospective observational study
16038824|NCT02604290|Device|Kinesio Taping method|"The tape is applied depending on the physical examination:
~Muscular technique is placed along paravertebral muscles if back pain in flexion or extension improves when skin/fascial mobilisation is applied in the direction of paravertebral muscle fibers; the base is placed up or down if the mobilisation direction is up or down respectively.
~Space technique is placed horizontally over the painful spinal segmental level if back pain in flexion or extension improves when skin/fascial mobilisation is applied approaching to a central point.
~Fascia technique is placed horizontally over the painful area in paravertebral muscles if back pain in flexion or extension improves when skin/fascial mobilisation is applied transverse to the paravertebral muscle fibers."
16038825|NCT02604290|Device|Kinesio Taping sham|The tape is applied with 0% tension, horizontally over two non-tender to palpation spinal segmental levels. The patient is kept in neutral position.
16038826|NCT02604277|Behavioral|Interpersonal and Social Rhythm Therapy (ISRT)|Interpersonal and Social Rhythm Therapy (ISRT) will be given once a week over a six week period for 55-60 minutes. ISRT emphasizes identifying and maintaining a regular routine in daily life. It includes addressing sleep and solving interpersonal concerns and conflicts by focusing on daily routine.
16038827|NCT02604277|Behavioral|Bipolar-Specific Cognitive Behavioral Therapy (CBT)|Bipolar-Specific Cognitive Behavioral Therapy (CBT) will be given once a week over a six week period for 55-60 minutes.The therapy is directly focused on eliminating or managing specific problems experienced by people with Bipolar Disorder. As part of this intervention, participant's maladaptive thoughts, behaviors and emotions are identified followed by learning how to challenge negative thoughts and reframing into positive, more adaptive thoughts. Additionally, the intervention involves enhancing the participant's coping skills and the ability to view a situation more objectively.
16038828|NCT02604277|Behavioral|Mindfulness-Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR) will be given once a week over a six week period for 55-60 minutes. MBSR is a structured intervention that utilizes mindfulness meditation to reduce suffering associated with physical and psychiatric illnesses. MBSR is nonreligious in nature and aims to encourage an enhanced awareness of moment-to-moment experience of noticeable mental processes.
16038829|NCT02604277|Behavioral|Psycho-education & Understanding Bipolar Medications Therapy|Psycho-education & Understanding Bipolar Medications Therapy will be given once a week over a six week period for 55-60 minutes. Psycho-education & Understanding Bipolar Medications Therapy aims to provide psycho-education about Bipolar Depression as well as provide a platform for participants to address concerns about managing their illness. Issues such as managing symptoms, reducing relapses and hospitalizations as well as maintaining gains will be discussed
16038830|NCT02604264|Device|ClearGuard HD end cap|The ClearGuard HD End Cap elutes chlorhexidine acetate into the hemodialysis catheter hub
16038831|NCT02604251|Device|KLOX BioPhotonic WoundGel System|Patients will then be re-randomized to one of the three comparisons: treatment starting on day 7 post-surgery, treatment starting on Day 21 post-surgery, or two consecutive treatments applied once weekly.
16038832|NCT02604251|Device|Silicone sheets|Treatment of the surgical wounds with silicone sheets.
16038833|NCT02604238|Drug|Alteplase|Enoxaparin (1mg) 100UI aXa/kg/sc [LMWH], 15 -30 minutes prior to administration of intravenous (iv) bolus loading dose of 10 mg in 1 min, followed by iv infusion of 40 mg within two hours (for patients weighing <50 kg, a loading dose of bolus of 0.5 mg in 1 min, followed by iv infusion of 40 mg in two hours); the infusion will be adjusted to maintain the value of aPTT between 50-70 seconds (1.5 to 2.5 times the reference value).
16038834|NCT02604225|Drug|Methoxyflurane|Participants randomised to the experimental arm will inhale methoxyflurane administered through the Penthrox® inhaler starting approximately one minute before insertion of the rectal probe.
16038835|NCT02604225|Drug|Placebo|Participants randomised to the control arm will inhale 0.9% saline administered through the Penthrox® inhaler starting approximately one minute before insertion of the rectal probe.
16038839|NCT02604212|Drug|antihistamine|All participants will be pretreated with an oral antihistamine. The antihistamine used should in general be an H1>H2 receptor blocker and would include diphenhydramine 50 mg, cetirizine 10 mg, chlorpheniramine 8 mg or hydroxyzine 50 mg. The Investigator is free to choose any of these antihistamines available locally and consistent with their country's Marketing Authorisation.
16038840|NCT02604212|Drug|tenofovir|All participants will take entecavir or tenofovir throughout the study. Participants will be instructed to take their medication daily.
16038841|NCT02604199|Drug|ARC-520 Injection|ARC-520 Injection was administered concomitantly, IV with 0.9% normal saline using an infusion rate of 0.4 mL/min for study treatment and 3.6 mL/min for saline.
16038842|NCT02604199|Other|placebo|Placebo was administered concomitantly, IV with 0.9% normal saline using an infusion rate of 0.4 mL/min for study treatment and 3.6 mL/min for saline.
16038843|NCT02604199|Drug|entecavir|All participants will take entecavir or tenofovir throughout the study. Participants will be instructed to take their medication daily.
16038844|NCT02604199|Drug|tenofovir|All participants will take entecavir or tenofovir throughout the study. Participants will be instructed to take their medication daily.
16038845|NCT02604199|Drug|antihistamine|All participants will be pretreated with an oral antihistamine, administered 2 hours (±30 minutes) pre-dose. The antihistamine used should in general be an H1>H2 receptor blocker and would include diphenhydramine 50 mg, cetirizine 10 mg, chlorpheniramine 8 mg or hydroxyzine 50 mg. The Investigator is free to choose any of these antihistamines available locally and consistent with their country's Marketing Authorisation.
16038846|NCT02604186|Other|Botulinum Toxin Injections|Each patient in the treatment group will receive 400 units of botulinum toxin. 100 units will be injected at adductors at each leg and 100 units will be applied in each triceps surae bilaterally.
16038847|NCT02604186|Other|Placebo Injections|Each patient in the placebo group will receive sterile sodium chloride injections at adductors and triceps surae muscles bilaterally.
16038848|NCT02604173|Drug|Budesonide|Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness
16038849|NCT02604173|Drug|Acetazolamide|Inhaled Budesonide vs. PO Acetazolamide vs. Placebo for prevention of Acute Mountain Sickness
16038850|NCT02604173|Drug|Placebo|Placebo pill and sham inhaler
16038851|NCT02604160|Drug|LY3113593|Administered by slow intravenous (IV) infusion.
16038852|NCT02604160|Drug|Placebo|Administered by slow intravenous (IV) infusion.
16038853|NCT02604147|Device|Inspiratory pressure-threshold muscle training device.|The participants who will be allocated in this simulated intervention group will have to do a simulated inspiratory muscle training protocol through the inspiratory muscle exerciser POWERbreathe, model Sports Plus Heavy Resistance (POWERbreathe; HAB International Ltd., Warwickshire, United Kingdom) for 12 weeks five times at week and twice daily, with a load of 15% of maximal inspiratory pressure without progression. In each session will be requested to the volunteers make 30 slow breaths, which will be constantly supervised by the researchers.
16038854|NCT02604147|Device|nspiratory pressure-threshold muscle training device.|The participants who will be allocated in this intervention group will have to make a inspiratory muscle training protocol with progressive loads through the inspiratory muscle exerciser POWERbreathe, model Sports Plus Heavy Resistance (POWERbreathe; HAB International Ltd., Warwickshire, United Kingdom) for 12 weeks five times at week and twice daily, with an initial load of 50% of maximal inspiratory pressure, progressing to 60% after the fourth week, and 70% after the octave week. In each session will be requested to volunteers who performed 30 maximal and prolonged inspiration, maintaining the diaphragmatic breathing, which will be constantly supervised by the researchers.
16038855|NCT02604134|Procedure|Prophylaxis|A dental prophylaxis is a cleaning procedure performed to thoroughly clean the teeth. Prophylaxis is an important dental treatment for halting the progression of periodontal disease and gingivitis.
16038856|NCT02604134|Drug|Fluoride varnish|Fluoride varnish is a highly concentrated form of fluoride which is applied to the tooth's surface, by a dentist, dental hygienist or other health care professional, as a type of topical fluoride therapy.
16038857|NCT02604134|Drug|Silver Nitrate|a small amount will be applied to the tooth via a cotton applicator. Silver nitrate is a colorless, odorless, transparent solution used as an escharotic, dehydrating and sclerosing agent.
16038858|NCT02604121|Device|Orcellex® Rovers brush|transepithelial brushing
16038859|NCT02604108|Behavioral|Physical Exercise|"The Physical Exercise arm includes a training workshop and electronic health messages related to positive psychology and physical activity for all participants in physical exercise group. Skills on program design and implementation will be conducted for those participants, who will design and implement community-based family intervention to the public.
~The training workshop includes: (i) 2-day core session and half day booster session for trainers; and (ii) 1-day core session and half day booster session for ambassadors"
16038860|NCT02604108|Behavioral|Healthy Diet|"The Healthy Diet arm includes a training workshop and electronic health messages related to positive psychology and health diet for all participants in healthy diet group. Skills on program design and implementation will be conducted for those participants, who will design and implement community-based family intervention to the public.
~The training workshop includes: (i) 2-day core session and half day booster session for trainers; and (ii) 1-day core session and half day booster session for ambassadors"
16038861|NCT02604095|Dietary Supplement|melatonin|Take one tablet (containing melatonin 3mg, calcium 52mg, vitamin B6 5mg) at bedtime everyday for 12 weeks.
16038862|NCT02604082|Other|Vibrocompression (VB)|Vibrocompression is a physical therapy technique, that aims to clear the airways of patients on mechanical ventilation (MV)
16038863|NCT02604082|Other|Hyperinflation (HMV)|Hyperinflation technique with mechanical ventilator which aims to clear the airways of patients on mechanical ventilation
16038864|NCT02604082|Other|HMV+VB|Association between Vibrocompression and Hyperinflation with mechanical ventilator
16038865|NCT02604069|Device|Continuous Glucose Monitor|
16038866|NCT02604056|Behavioral|Audit + Feedback|Online Audit + Feedback practice reports detailing prescribing performance for this class of medication for each prescriber in the nursing home. (Details: http://www.hqontario.ca/Quality-Improvement/Practice-Reports/Primary-Care)
16038907|NCT02603809|Drug|Aprocitentan 10 mg|Two capsules of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks.
16039125|NCT02602288|Behavioral|Telebased nutrition counseling|Telephone counseling to promote nutritious eating practices in the family.
16038867|NCT02604056|Behavioral|Audit + Feedback + Educational Outreach|"The Educational Outreach program will be delivered by academic detailers, health professionals (often nurses or pharmacists) who have received specific intensive training to support prescribing providers in a particular environment, in this case long-term care homes, to make the best or appropriate clinical decisions as possible. It is defined as: an innovative method of service-oriented educational outreach for front-line clinicians. It combines the interactive, one-on-one communication approach of industry detailers with the evidence-based, non-commercial information of academia. The Educational Outreach will be delivered in addition to online Audit + Feedback practice reports, which detail prescribing performance for this class of medication for each prescriber in the nursing home."
16038868|NCT02604043|Other|pH monitoring|After endotracheal intubation, the impedence/pH probe will be placed under indirect visualization using a McGrath MAC video laryngoscope directly above the vocal cords. The sensor will remain in place for the duration of the surgery or for 24 hours in ICU patients. At that time, the device will be manually removed by a member of the study staff.
16038869|NCT02604043|Other|accelerometer monitoring|Patient position will be continuously monitored with the accelerometer for the duration of the pH monitoring period.
16038870|NCT02604030|Other|Upper limb function|Physical therapy program will be done in two steps, with 8 sessions each one (twice a week for four weeks). First, 8 sessions of passive mobilization in glenohumeral joint and scapular, scar massage, lymphatic drainage, stretching exercises will be completed. Second, 8 sessions of upper limb strengthening and stretching exercises for upper limb. Each session will be completed in 1 hour (twice a week) during two months.
16038871|NCT02604017|Drug|ABT-493/ABT-530|Tablet; ABT-493 coformulated with ABT-530
16038872|NCT02604004|Drug|Epivir ® tablet 150-mg single dose (drug reference)|Bioequivalence lamivudine 150 mg tablets fasting condition
16038873|NCT02604004|Drug|Lamivudine 150-mg tablet single dose (drug test)|Bioequivalence lamivudine 150 mg tablets fasting condition
16038874|NCT02603991|Procedure|PINS Vagus Nerve Stimulator|The stimulators are implanted in the body,with the stimulation of the IPG
16038875|NCT02603991|Drug|Levetiracetam|The best anti-epileptic drugs to patients who participate in this study，Levetiracetam，
16038876|NCT02603978|Behavioral|BASICS|A 2-hour group intervention focused on reducing alcohol use with the use of motivational interviewing
16038877|NCT02603978|Behavioral|Bystander and Social Norms|A 2-hour group intervention focused on increasing healthy sexual behaviors and prosocial bystander behavior
16038878|NCT02603978|Behavioral|Combined BASICS and Bystander|A 2-session, 4-hour group that consists of both BASICS and the Bystander intervention
16038879|NCT02603965|Radiation|Copper Cu 64 TP3805|Given IV
16038880|NCT02603965|Procedure|Positron Emission Tomography|Undergo Cu-64-TP3805 PET(Positron Emission Tomography)/CT
16038881|NCT02603965|Procedure|Computed Tomography|Undergo Cu-64-TP3805 PET/CT (Computed Tomography)
16038882|NCT02603965|Procedure|Radical Prostatectomy|Undergo radical prostatectomy
16038883|NCT02603965|Other|Laboratory Biomarker Analysis|Correlative studies
16038884|NCT02603952|Drug|Oseltamivir|75 mg capsules orally BID from Day 1 to Day 5.
16038885|NCT02603952|Drug|MEDI8852|MEDI8852 is a human IgG1 kappa monoclonal antibody (mAb) administered as a single IV infusion of 750 mg or 3000 mg on Day 1.
16038886|NCT02603952|Drug|Placebo|Placebo is salt-water solution containing no active ingredients and administered as a single IV infusion on Day 1.
16038887|NCT02603939|Procedure|Joint replacement surgery|We are assessing pain responses in participants with osteoarthritis before an after joint replacement surgery
16038888|NCT02603926|Drug|Allopregnanolone|Allopregnanolone is an endogenous inhibitory pregnane neurosteroid. It is synthesized from progesterone, and is a potent positive allosteric modulator of the action of γ-aminobutyric acid at GABAA receptor. Subjects will receive up to 12 infusions in the study. Subjects will all begin with 2.0 mg dosage. If tolerated, the next infusion will be 4.0 mg, and if that is tolerated, the next infusion will be 6.0 mg. Subject infusions will remain stable at the highest dosage tolerated for the remainder of the study. Each infusion will consist of 2.0 mg, 4.0 mg, or 6.0 mg aliquots of the 0.5 mg/ml allopregnanolone in 6% sulfobutylether-β-cyclodextrin with 0.9% sodium chloride injection solution.
16038889|NCT02603900|Drug|ropivacaine|15 ml 0.5% Ropivicaine for primary adductor canal block under ultrasound guidance and 0.2% Ropivicaine infusion 10 ml/hr.
16038890|NCT02603900|Drug|bupivacaine|20 ml bupivacaine ( Marcaine 0.25% with epinephrine 1:200000, Hospira Inc. Lake Forest, IL) diluted with 40 ml of normal saline injected intraoperatively into the knee joint before closure.
16038891|NCT02603900|Device|Sham Adductor Canal Catheter|Sham catheter placement via ultrasound-guided adductor canal block and 10ml/hr saline via OnQ Pump via continuous catheter in adductor canal.
16038892|NCT02603900|Device|Adductor Canal Catheter|Catheter placed in adductor canal via ultrasound guidance and continuous infusion via OnQ pump.
16038893|NCT02603887|Other|Laboratory Biomarker Analysis|Correlative studies
16038894|NCT02603887|Biological|Pembrolizumab|Given IV
16038895|NCT02603874|Device|Target Tape|Comparing procedures using Target Tape against procedures not using Target Tape
16038896|NCT02603861|Drug|LY3154207|LY3154207 administered orally.
16038897|NCT02603861|Drug|Placebo|Placebo administered orally.
16038898|NCT02603861|Drug|Modafinil|Modafinil administered orally.
16038899|NCT02603848|Drug|Ibuprofen|(10mg/kg; maximum 600 mg) every six hours as needed
16038900|NCT02603848|Drug|Morphine|0.2 mg/ kg morphine suspension (maximum 10mg) every four hours as needed
16038901|NCT02603835|Device|SSO2 Therapy|Delivery of SSO2 Therapy for 60 minutes selectively into the left main coronary artery (LMCA) using the TherOx DownStream System along with a single use disposable device called the TherOx DownStream Cartridge and a commercially available, qualified SSO2 delivery catheter
16038902|NCT02603822|Dietary Supplement|12C mannitol|12C mannitol 100 mg
16038903|NCT02603822|Drug|Indomethacin|Subjects will receive six 25 mg capsules of Indomethacin (immediate release). The subjects will take 3 capsules 8 hours before the timing of visit 5 (before fasting), and 3 additional capsules 30 minutes before visit 5.
16038904|NCT02603822|Dietary Supplement|13C mannitol|13C mannitol 100 mg
16038905|NCT02603822|Dietary Supplement|Lactulose|lactulose 1 g
16038906|NCT02603809|Drug|Aprocitentan 5 mg|One capsule of 5 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.
16038908|NCT02603809|Drug|Aprocitentan 25 mg|One capsule of 25 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.
16038909|NCT02603809|Drug|Aprocitentan 50 mg|One capsule of 50 mg aprocitentan, orally, once daily in the morning for 8 weeks, along with placebo capsule matching lisinopril.
16038910|NCT02603809|Drug|Lisinopril 20 mg|One capsule of 20 mg lisinopril, orally, once daily in the morning for 8 weeks, along with placebo capsule matching aprocitentan
16038911|NCT02603809|Drug|Placebo|One capsule each of placebo matching aprocitentan and placebo matching lisinopril orally, once daily in the morning for 8 weeks.
16038912|NCT02603796|Other|3D Scan of nares|3D scan of subjects nose prior to implementation of ncpap and upon discontinuation of ncpap.
16038913|NCT02603783|Other|Capsaicin|capsaicin 1,5 mg
16038914|NCT02603783|Other|Placebo|0,9% saline 75 ml
16038915|NCT02603770|Drug|XueZhiKang|
16038916|NCT02603770|Drug|Lovastatin|
16038917|NCT02603757|Dietary Supplement|cholecalciferol|2,000 IU of Vitamin D3 daily and 50,000 IU Vitamin D3 daily
16038918|NCT02603744|Biological|Intraovarian injection of Adipose derived Stromal cells (ADSCs)|Intra-ovarian injection of Adipose derived mesenchymal stem cells.
16038919|NCT02603718|Other|Rehabilitation treatment|
16038920|NCT02603705|Drug|Oxycodone extended-release|
16038921|NCT02603692|Other|PROMIS-QOL|PROMIS questionnaires completed every 3 months for up to 2 years.
16038922|NCT02603679|Drug|Paclitaxel|Any brand of paclitaxel may be used, excluding nab-paclitaxel
16038923|NCT02603679|Drug|Tamoxifen + Palbociclib|Any brand of tamoxifen may be used
16038924|NCT02603679|Drug|Aromatase Inhibitor + Palbociclib|Any brand of letrozole, anastrozole or exemestane may be used
16038925|NCT02603679|Drug|Goserelin + Aromatase Inhibitor + Palbociclib|Any brand of letrozole, anastrozole or exemestane may be used
16038926|NCT02603666|Device|Fibroscan|Ultrasound by specific wavelength developed for elastography, repeated measures according to the manufacturer's instructions.
16038927|NCT02603653|Device|Virtual radial task in 3D|The virtual radial task is a labyrinth in 3D with twelve ways. The primary aim of our study is the evaluation of persistent cognitive impairments (hippocampal memory) according to the responses of participants after instructions to choose the right way in the labyrinth.
16038928|NCT02603640|Device|MRI scanning|
16038929|NCT02603614|Drug|Cenderitide|Cenderitide is a dual receptor natriuretic peptide.
16038930|NCT02603614|Drug|Placebo|Placebo control
16038931|NCT02603601|Behavioral|Mind-body lifestyle intervention|
16038932|NCT02603601|Behavioral|Standard lifestyle intervention|
16038933|NCT02603588|Procedure|active sphenopalatine ganglion acupuncture|"The acupuncture point was selected in the sphenopalatine ganglion (unilateral side). The acupuncture needle was inserted from the lower border of the zygomatic arch, slightly posterior to the suture protuberance between the zygomatic process and temporal process. The needle was rotated until the participant felt de-qi sensations."
16038934|NCT02603588|Procedure|sham sphenopalatine ganglion acupuncture|The acupuncture point was selected same to the sphenopalatine ganglion. But the needle was inserted at the selected acupuncture site to a depth of only 2-3cm, and the procedure of rotating, twirling and thrusting the needle was repeated, in order to blind the subject to the sham treatment.
16038935|NCT02603575|Drug|caspofungin|70mg ivdrip the first day, then 50mg ivdrip qd
16038936|NCT02603575|Drug|corticosteroids|40mg ivdrip q12h for 5 days 40mg ivdrip qd for 5 days 20mg po for 11 days
16038937|NCT02603575|Drug|Sulfanilamides|1.92g q8h
16038938|NCT02603562|Biological|ATYR1940|ATYR1940 will be administered as an IV infusion at doses of 0.3, 1.0, and 3.0 mg/kg using intrapatient dose escalation. The dose level in this study will not exceed 3.0 mg/kg
16038939|NCT02603562|Biological|Placebo|An initial IV infusion of placebo will be supplied as normal saline, and administered over a 30-minute period at Week 1.
16038940|NCT02603549|Other|Pituitary panel will be drawn pre-op and post-op for all patients.|
16038941|NCT02603536|Other|WelTel|An evidence-based, text messaging solution for improving patient adherence.
16038942|NCT02603523|Behavioral|Senior Dance|The Senior Dance classes consist of different choreographies, which include rhythmic and simple movements with rhythmic folk songs. During the classes, participants can practice the movements sitting or standing, quickly or slowly, in circles, individually, in pairs or in small groups. The concentration required to learn the choreographies challenges balance, motor coordination and cognitive function.
16038943|NCT02603510|Drug|SAR342434|"Pharmaceutical form:solution
~Route of administration: subcutaneous"
16038944|NCT02603510|Drug|insulin lispro|"Pharmaceutical form:solution
~Route of administration: subcutaneous"
16038945|NCT02603497|Drug|ASP015K|oral
16038946|NCT02603471|Other|Informational group|A pamphlet will be provided to the participants with information about ART adherence, HIV and relapse prevention.
16038947|NCT02603471|Behavioral|Text Messaging CBT (TXT-CBT)|Those assigned to TXT-CBT will be given a treatment manual (developed in Phase I) containing descriptions of core therapeutic content/topics for each week. HIV-infected participants will have initial meeting with a CBT clinician to review the core CBT concepts for promoting ART adherence. The 3 most applicable medication adherence skills will be identified for emphasis in tailored messages. A research coordinator will meet with the participants weekly at data collection visits throughout the intervention phase to answer any technical questions and ensure that the intervention program is working properly.
16038948|NCT02603458|Drug|NRX-1074|Participants will receive two IV NRX-1074 infusions 1 week apart, each lasting 1 minute.
16038949|NCT02603458|Drug|Placebo|Patients will receive two IV placebo infusions 1 week apart, each lasting 1 minute.
16038950|NCT02603445|Drug|BCL201|
16038951|NCT02603445|Drug|Idelalisib|
16038952|NCT02603432|Biological|Avelumab|1 hour intravenous infusion every 2 weeks (Q2W) in 4 week cycles
16038953|NCT02603432|Other|Best Supportive Care|BSC will be administered as deemed appropriate by the treating physician, and could include treatment with antibiotics, nutritional support, correction of metabolic disorders, optimal symptom control and pain management (including palliative radiotherapy), etc. BSC does not include any active anti-tumor therapy, however local radiotherapy of isolated lesions with palliative intent is acceptable.
16038954|NCT02603432|Biological|Following the planned interim analysis for this study: Avelumab|1 hour intravenous infusion every 2 weeks (Q2W) in 4 week cycles
16038955|NCT02603419|Drug|Avelumab|Anti-PD-L1 antibody at X1 mg IV every 2 weeks to optimize dosing for expansion. Treatment with avelumab will continue until disease progression.
16038956|NCT02603419|Drug|Avelumab|Anti-PD-L1 antibody at X2 mg IV every 2 weeks to optimize dosing for expansion. Treatment with avelumab will continue until disease progression.
16038957|NCT02603419|Drug|Avelumab|Anti-PD-L1 antibody at X3 mg IV every 3 weeks to optimize dosing for expansion. Treatment with avelumab will continue until disease progression
16038958|NCT02603419|Drug|Avelumab|Anti-PD-L1 antibody at X3 mg IV every 2 weeks to optimize dosing for expansion. Treatment with avelumab will continue until disease progression
16038959|NCT02603419|Drug|Avelumab|Anti-PD-L1 antibody at X mg IV every 2 weeks. Treatment with avelumab will continue until disease progression
16038960|NCT02603419|Drug|Avelumab|Anti-PD-L1 antibody at X1 mg IV every 2 weeks which can be escalated to X4 mg every 2 weeks based on safety and efficacy. Treatment with avelumab will continue until disease progression.
16038961|NCT02603406|Drug|erythropoietin|
16038962|NCT02603393|Drug|QVA149|QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept 1 SDDPI
16038963|NCT02603393|Drug|Tiotropium|Tiotropium will be supplied as commercially available blisters, delivered via HandiHaler®
16038964|NCT02603393|Drug|Salmeterol/fluticasone|Salmeterol/fluticasone propionate dry inhalation powder delivered via Accuhaler™
16038965|NCT02603380|Other|No intervention|This is an observational study. No intervention will be given.
16038966|NCT02603367|Other|Communication Intervention|Undergo communication coaching
16038967|NCT02603367|Other|Educational Intervention|Receive COMFORT communication curriculum
16038968|NCT02603367|Other|Psychosocial Support for Caregiver|Undergo communication coaching
16038969|NCT02603367|Other|Questionnaire Administration|Complete questionnaires
16038970|NCT02603354|Drug|peroxide gel tooth bleaching 6%|gel of hygrogen peroxide for teeth bleaching in a low concentration (6%)
16038971|NCT02603341|Radiation|Photon|Photon Therapy:once a day, 5 days a week, for 5 to 7 weeks
16038972|NCT02603341|Radiation|Proton|Proton Therapy: once a day, 5 days a week, for 5 to 7 weeks
16038975|NCT02603315|Other|marker CD74 and vascular endothelial growth factor VEGF|correlate the result of vascularity test done on paraffin blocks on both types of malignant pleural mesothelioma patients diagnosed and receive treatment and evaluated after treatment
16038976|NCT02603302|Radiation|Dose Escalation Radiotherapy|RT (3D conformal RT) 45 Gy to the whole pelvis + boost 14.4 Gy to the GTV Chemotherapy with 5-FU
16038977|NCT02603302|Procedure|Delayed surgery|Surgery after 8 weeks with TME (total mesorectal excision)
16038978|NCT02603289|Device|Invisalign|
16038979|NCT02603276|Dietary Supplement|Plant sterols|Plant sterols 800 mg/dose, 1 liquid stick per day, for 8 weeks
16038980|NCT02603276|Dietary Supplement|Red Yeast Rice|Red Yeast Rice titrated in 5 mg monacolin K per daily dose, 1 liquid stick per day, for 8 weeks
16038981|NCT02603276|Dietary Supplement|Red Yeast Rice plus Plant sterols|Red Yeast Rice titrated in 5 mg monacolin K per daily dose plus Plant sterols 800 mg/dose, together in 1 liquid stick per day, for 8 weeks
16038982|NCT02603263|Other|Social Norms Poster|"A poster containing a social norms message: Most people here choose to eat vegetables with their lunch"
16038983|NCT02603237|Other|Glucose tolerance test|Standardized oral glucose tolerance test (75 g oral glucose) and blood collection before and 2hrs after the glucose load
16038984|NCT02603237|Other|Fat tolerance test|Oral fat tolerance will be provided to fasting participants and blood samples will be collected before and 4 hrs after the fat load.
16038985|NCT02603224|Drug|MRG-201|Intradermal injection of single ascending doses and multiple ascending doses in healthy volunteers.
16038986|NCT02603224|Drug|Placebo|Intradermal injection of placebo at a second site in healthy volunteers. Each subject will serve as their own control.
16038987|NCT02603211|Device|tactile imaging sensor or system made in our laboratory|This is a camera with elastomer tip and LED lights. It is a harmless device.
16038988|NCT02603198|Drug|mepivacaine chloridrato epinephrine|local anesthesia for tooth removal
16038989|NCT02603198|Drug|mepivacaine chloridrato levonordefrin|local anesthesia for tooth removal
16038990|NCT02603185|Drug|Hemay007|
16038991|NCT02603185|Drug|placebo|
16038992|NCT02603172|Drug|GSK3039294|GSK3039294 will be provided as white, opaque capsules. A single capsule or multiple capsules (20 mg to 200 mg), depending on the dosage required, will be taken orally with water.
16038993|NCT02603159|Drug|Capecitabine(Aibin)|Capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 or 10 weeks in total
16038994|NCT02603159|Radiation|radiotherapy|Concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity
16038995|NCT02603146|Drug|Hydroxychloroquine|As described. Dosing will be based upon Screening IBW.
16038996|NCT02603146|Drug|HCQ Placebo|As described. Dosing will be based upon Screening IBW.
16038997|NCT02603133|Behavioral|Three Good Things|"In this tool participants reflect on good things that happened that day during evenings across 10 days. Participants are also able to voluntarily share their good things and read other participants' good things through the nightly anonymous log. By savoring good moments from earlier that day, participants are thought to shift from the natural focus on what went poorly due to negativity bias1 to an appreciation for what went well. This shift in focus is thought to reduce rumination and depression symptoms. In prior research, 3GTs was found to increase happiness and decrease depression in internet participants.2 In prior cohorts of 3GTs, we saw improvements in burnout, depression symptoms, work-life balance, and happiness. Participants also report benefiting from viewing nightly Three Good Things logs of others."
16038998|NCT02603133|Behavioral|Gratitude|In this tool participants are offered the opportunity to cultivate gratitude toward others through a guided gratitude letter writing exercise.2 Through expressing gratitude, we learn more about our vital connections to others, often in surprising and meaningful ways. Previous research has found that gratitude interventions increase well-being in a number of ways, particularly in boosting positive affect.
16039073|NCT02602574|Other|heparinized peripheral venous blood and urine sample.|All patients will be taken heparinized peripheral venous blood and urine sample
16039074|NCT02602561|Dietary Supplement|HMB|
16038999|NCT02603133|Behavioral|Random Acts of Kindess|In this tool, participants report kind acts that they have committed, received, and/or witnessed, each day. By committing random acts of kindness participants experience a boost of positive emotions, and report lower negative affect. Recipients of acts of kindness benefit as well.
16039000|NCT02603133|Behavioral|Awe|This tool provides participants the opportunity to recount in detail one of their own experiences of awe, and encourages them to be on the lookout for new ones (even minor examples) over a few days. When we experience awe, our sense of time expands, we are kinder to others, we experience higher life satisfaction, and we prefer experiences over material things.
16039001|NCT02603133|Behavioral|1 Good Chat|This tool uses the latest research on cultivating relationships and increasing social connection. Feeling socially connected is linked to health and well-being outcomes, including longevity.6 The 1 Good Chat tool asks participants to reflect on good conversations and to note the prosocial behaviors that he/she and the other person engaged in
16039002|NCT02603120|Drug|ABC/DTG/3TC|600/50/300 mg FDC tablets administered orally once daily without regard to food
16039003|NCT02603120|Drug|B/F/TAF|50/200/25 mg FDC tablets administered orally once daily without regard to food
16039004|NCT02603120|Drug|ABC/DTG/3TC Placebo|Tablets administered orally once daily without regard to food
16039005|NCT02603120|Drug|B/F/TAF Placebo|Tablets administered orally once daily without regard to food
16039006|NCT02603107|Drug|RTV|100 mg capsule coadministered orally with ATV or DRV once daily with food
16039007|NCT02603107|Drug|ATV|300 mg capsule administered orally once daily with food
16039008|NCT02603107|Drug|DRV|800 mg tablet administered orally once daily with food
16039009|NCT02603107|Drug|COBI|150 mg tablet coadministered orally with ATV or DRV once daily with food
16039010|NCT02603107|Drug|ATV/co|300/150 mg FDC tablet administered orally once daily with food
16039011|NCT02603107|Drug|DRV/co|800/150 mg FDC tablet administered orally once daily with food
16039012|NCT02603107|Drug|FTC/TDF|200/300 mg FDC tablet administered orally once daily without regard to food
16039013|NCT02603107|Drug|ABC/3TC|600/300 mg tablet administered orally once daily with or without regard to food
16039014|NCT02603107|Drug|B/F/TAF|50/200/25 mg FDC tablet administered orally once daily without regard to food
16039015|NCT02603094|Procedure|clear fluid ingestion|drinking of clear fluid in preoperative period
16039016|NCT02603081|Drug|SPI-1005|Ebselen is a small molecule mimic and inducer of glutathione peroxidase (GPx). GPx reduces reactive oxygen species by the binding of free radicals to its selenium moiety. Ebselen has strong anti-inflammatory characteristics.
16039017|NCT02603068|Drug|Oral treprostinil|Oral treprostinil will be administered as TID dosing for up to 16 Weeks.
16039018|NCT02603055|Biological|30μg/0.5ml Hepatitis E vaccine|three doses, 30μg/0.5ml per dose
16039019|NCT02603055|Biological|30μg/0.5ml Recombinant Hepatitis E vaccine|30μg/0.5ml Hepatitis E vaccine developed by Xiamen innovax biotech Co.,Ltd.,three doses, 30μg/0.5ml per dose
16039020|NCT02603029|Other|Placebo cream|Subjects will use placebo cream twice per day for 12 weeks on one half of the face and of the gluteal area.
16039021|NCT02603029|Other|Belinal cream|Subjects will use Belinal cream twice per day for 12 weeks on the other half of the face and of the gluteal area.
16039022|NCT02603016|Drug|GLSE compound|
16039023|NCT02603016|Drug|Maitake mushroom extract compound|
16039024|NCT02603016|Drug|Ginseng compound|
16039025|NCT02603003|Drug|JinFuKang|po.tid.30ml
16039026|NCT02603003|Drug|Cisplatin|According to the individual patient's condition
16039027|NCT02603003|Drug|Pemetrexed|According to the individual patient's condition
16039028|NCT02602990|Device|SQUID™|
16039029|NCT02602977|Other|Multiple-dose Remote Ischemic Preconditioning|"A blood-pressure cuff with handheld rubber inflation balloon and manometer is placed on the non-dominant arm of the subject. The cuff will be placed proximally from the elbow with the most proximal part of the cuff placed in the armpit. The cuff will be inflated to 250 mmHg after which a 5 minute countdown is started. After 5 minutes the pressure is released and the 5 minute countdown for reperfusion is started. This concludes one cycle out of a total of four.
~1 RIPC-dose consists of 4 cycles of 5 minute ischemia followed by 5 minute reperfusion as described above.
~Multiple-dose RIPC consists of a daily dose of 1 RIPC as described above for 7 consecutive days."
16039030|NCT02602977|Other|Single-dose Remote Ischemic Preconditioning|"A blood-pressure cuff with handheld rubber inflation balloon and manometer is placed on the non-dominant arm of the subject. The cuff will be placed proximally from the elbow with the most proximal part of the cuff placed in the armpit. The cuff will be inflated to 250 mmHg after which a 5 minute countdown is started. After 5 minutes the pressure is released and the 5 minute countdown for reperfusion is started. This concludes one cycle out of a total of four.
~1 RIPC-dose consists of 4 cycles of 5 minute ischemia followed by 5 minute reperfusion as described above.
~Single-dose RIPC consists of 1 dose of RIPC as described above"
16039031|NCT02602977|Biological|LPS infusion|To achieve a controlled inflammatory state, 30 subjects (multiple-dose RIPC group [n=10], single-dose RIPC group [n=10] and control group [n=10]) will receive LPS intravenously. The LPS at a dose of 2 ng/kg iv will be injected in 1 minute.
16039032|NCT02602964|Other|Deep neuromsucular block|Deep or standard neuromuscular block
16039033|NCT02602951|Other|Pilot MRI program|Pilot MRI program
16039034|NCT02602951|Other|MRI with 4D Flow sequence|MRI with 4D Flow sequence
16039035|NCT02602938|Drug|Aspirin|Take aspirin (100mg) orally once a day for 2 months
16039036|NCT02602925|Other|Dose decrease|Treatment strategy change: dose decrease based on PASI and DLQI
16039037|NCT02602925|Other|Usual care|Usual care
16039038|NCT02602912|Device|Injeq Bioimpedance Probe (BIP) Needle|Injeq Bioimpedance Probe (BIP) Needle is a spinal needle that has bioimpedance measurement capability. It consists of traditional needle cannulae and removable bioimpedance probe which enables the measurement of bioimpedance. The needle is connected to measurement device and tissue identifying algorithm. Bioimpedance is measured during the operation and the algorithm detects when the needle tip is in contact with cerebrospinal fluid.
16039039|NCT02602899|Procedure|PINS'Deep Brain Stimulator device|deep brain stimulation of the PINS'IPG function to anterior nucleus of the thalamus is off in a short time
16039075|NCT02602561|Dietary Supplement|Placebo|
16039076|NCT02602548|Other|Culture|Specimens will be obtained and sent to the lab for cultures.
16039040|NCT02602886|Behavioral|Exposure and Response Prevention Therapy|The treatment includes both therapist-supervised and self-controlled exposure and ritual prevention exercises. 2 sessions per week, up to 15 sessions in total. Session time is 90 minutes. The majority of in-session time is spent conducting in vivo exposures. When engaging in E/RP tasks, patients are instructed to refrain from ritual engagement. Between-session homework is given the patient practicing the within-session E/RP task up to 90 minutes each day. Clinicians supplement E/RP with other cognitive-behavioral interventions including motivational strategies for resistant patients, Socratic dialogue, and behavioral experiments to test the validity of erroneous cognitions.
16039041|NCT02602873|Other|therapeutic drug monitoring|with therapeutic drug monitoring , dose of tacrolimus can be adjusted by therapeutic drug monitoring.
16039042|NCT02602860|Radiation|[11C]UCB-J|"Pharmaceutical form: Sterile solution for intravenous infusion
~Concentration: 20 mCi
~Route of Administration: iv"
16039043|NCT02602860|Drug|Brivaracetam|"Pharmaceutical form: Sterile solution for intravenous infusion
~Concentration: 10 mg/ml
~Route of Administration: iv"
16039044|NCT02602860|Drug|Levetiracetam|"Pharmaceutical form: Sterile solution for intravenous infusion
~Concentration: 100 mg/ml
~Route of Administration: iv"
16039045|NCT02602860|Drug|Brivaracetam|"Pharmaceutical form: Tablets for oral intake
~Concentration: 25 mg
~Route of Administration: oral"
16039046|NCT02602847|Biological|cccDNA assay on liver biopsy|cccDNA assay will be performed on liver biopsies at different times : During transplantation : Liver biopsy of explant and graft and virological biology Between M1 to M3 after transplantation : Liver biopsy between 1 to 3 months after transplantation M12 : Liver biopsy 12 months after transplantation
16039047|NCT02602834|Other|interval training|4 intervals with high intensity on treadmill, and approximately 3 minutes rest between intervals.
16039048|NCT02602834|Other|moderate exercise|30 minutes (moderate intensity) aerobic exercise on treadmill without rest.
16039049|NCT02602795|Behavioral|Acceptance and Commitment Therapy|The intervention is based on Acceptance and Commitment Therapy and will be tailored to help participants develop target adaptive responses to negative affect and other negative internal stimuli related to opioid detoxification.
16039050|NCT02602795|Behavioral|Information Motivation Behavioral Model|This intervention is based on the Information Motivation Behavior model for HIV/STI risk reduction and is tailored to more directly address HIV/STI risk among opioid dependent patients.
16039051|NCT02602769|Diagnostic Test|Transcriptome profiling|The investigators will obtain blood to extract peripheral mononuclear cells. These cells will be used to generate patient specific hypothalamic cells that will be used for transcriptome profiling.
16039052|NCT02602756|Radiation|Protontherapy|Proton-therapy consists in four consecutive sessions. The experimental arm consists in eight sessions. Irradiation is administered over two weeks, delivering a total dose of 60 Cobalt Gris Equivalent (CGE is the physical Gray dose multiplied by a biological factor of relative efficiency of 1.1 for protons compared to photons).
16039053|NCT02602743|Drug|Remifentanyl|0,25 µg/kg remifentanyl will be administered for induction in 1 minute. Then 0,1 µg/kg/h remifentanyl infusion will be started.
16039054|NCT02602743|Drug|Propofol|1 mg/kg propofol will be administered for induction and then 1 mg/kg/h propofol infusion will be started.
16039055|NCT02602743|Drug|Ketamine|2 mg/kg ketamine will be administered for induction in 1 minute.
16039056|NCT02602730|Behavioral|Break the Chain|Internet-based smoking cessation intervention designed for general population smokers with targeted materials for pregnant women. The program included a digital coaching component delivered via email at specific points as the user progresses through his/her quit process. Program content is based on Department of Health and Human Services Clinical Practice Guidelines for Treating Tobacco Use and Dependence.
16039057|NCT02602730|Behavioral|Clearing the Air|PDF version of smoking cessation booklet from National Cancer Institute.
16039058|NCT02602717|Other|lymph nodes cyto-punction|
16039059|NCT02602704|Drug|Bazedoxifene|Bazedoxifene 20mg/day (Viviant) for 48 weeks
16039060|NCT02602704|Drug|Calcium/Vit D|Elemental calcium 1200mg daily and vitamin D 800 IU daily (Caltrate D 400 * 2/day) for 48 weeks
16039061|NCT02602691|Other|AlloMap®|
16039062|NCT02602691|Procedure|Endomyocardial biopsies|
16039063|NCT02602678|Procedure|Supine then Prone position|One hour in supine position with CPAP (+7 cmH2O) then 15 min in supine position in spontaneous ventilation (wash-out) and one hour in prone position with CPAP (+7 cmH2O)
16039064|NCT02602678|Procedure|Prone then supine position|One hour in prone position with CPAP (+7 cmH2O) then 15 min in supine position in spontaneous ventilation (wash out ) and one hour in supine position with CPAP (+7 cmH2O)
16039065|NCT02602665|Procedure|Shallow catheter tip placement|for shallow placement tip of catheter placed 1 vertebral body above to even with the carina
16039066|NCT02602665|Procedure|Deep catheter tip placement|deep placement catheter tip is placed 1.5 to 2.5 vertebral bodies below the carina
16039067|NCT02602652|Biological|a live attenuated chimeric JE vaccine|"The study included 2 visits (D0 and D28). At the first visit (D0), children were enrolled, collected the blood sample for evaluate the baseline immune status and given a JE-CV as a booster dose. After vaccination, children were observed for 30 minutes to monitor any immediate adverse events. Parents were given a digital thermometer for axillary temperature measurement, a ruler for measuring injection site reactions and a diary card for recording a solicited injection site and systemic reactions.
~At the second visit (D28), blood samples were collected for evaluate the immunogenicity."
16039068|NCT02602639|Device|Functional electrical stimulation rowing (Odstock 4 channel neuromuscular stimulator with Concept 2 Rower)|Participants will strengthen their quadriceps and hamstrings using electrical stimulation for up to 12 weeks (using an Odstock 4 channel neuromuscular stimulator). Then participants will use a seated rower (Concept 2 Rower, fitted with a backrest that allows those with spinal cord injury to engage in rowing) in conjunction with the electrical stimulation for 12-24 weeks.
16039069|NCT02602613|Device|AMEND Mitral Valve Repair System|Annuloplasty ring applied in a transcatheter method
16039070|NCT02602600|Drug|Liraglutide|"Liraglutide up to 3 mg daily injected subcutaneously (minimum 1.2 mg daily) for 12 weeks.
~Weight maintenance diet for 2 weeks"
16039071|NCT02602587|Biological|Blood sample|additional samples of blood in acts planned in the prognostic or follow-up protocols.
16039072|NCT02602587|Biological|Bone marrow sample|additional bone marrow sample in acts planned in the prognostic or follow-up protocols.
16039077|NCT02602535|Behavioral|Mindfulness-Oriented Recovery Enhancement|Mindfulness-Oriented Recovery Enhancement (MORE) is a group behavioral intervention that unites mindfulness training, cognitive reappraisal, and positive psychological principles into an integrative intervention strategy targeting mechanisms of pain and opioid misuse.
16039078|NCT02602535|Behavioral|Support Group|A conventional support group will allow participants to express emotions, share experiences, and receive social support under the guidance of a skilled therapist.
16039079|NCT02602522|Drug|Shandong Danshen-Jiang-Fu Granule|Danshen-Jiang-Fu Granule is prepared from 4 kinds of Chinese herbs including Danshen (Salvia Miltiorrhiza), Paojiang (Roasted Ginger), Xiangfu(Rhizoma Cyperi), Wuyao(Lindera Aggregata). The producing area of Danshen in Shandong Danshen-Jiang-Fu Granule is Laiwu District in Shandong province.
16039080|NCT02602522|Drug|Sichuan Danshen-Jiang-Fu Granule|Danshen-Jiang-Fu Granule is prepared from 4 kinds of Chinese herbs including Danshen (Salvia Miltiorrhiza), Paojiang (Roasted Ginger), Xiangfu(Rhizoma Cyperi), Wuyao(Lindera Aggregata). The producing area of Danshen in Sichuan Danshen-Jiang-Fu Granule is Zhongjiang District in Sichuan province.
16039081|NCT02602509|Drug|Celecoxib|
16039082|NCT02602509|Drug|Rifampicin|
16039083|NCT02602509|Drug|Pyrazinamide|
16039084|NCT02602496|Other|Fruits and Vegetables|5 servings of fruits or vegetables
16039085|NCT02602496|Other|Whole Grain|3 servings of whole grain
16039086|NCT02602496|Other|Control|3 servings of refined grain
16039087|NCT02602483|Drug|Ibuprofen|
16039088|NCT02602483|Drug|Magnesium|
16039089|NCT02602483|Drug|Ascorbic Acid|
16039090|NCT02602483|Drug|Placebo|
16039091|NCT02602470|Drug|Azelaic Acid Gel including: Finacea (Azelaic Acid Gel 15%, BAY39-6251)|Azelaic Acid Gel 15%, Azelaic Acid Gel 15% w/Cleanser & Moisturizing
16039092|NCT02602470|Drug|Azelaic Acid Cream|Azelaic Acid Cream 20%
16039093|NCT02602470|Drug|Metronidazole gel|Metronidazole Gel 1%, Metronidazole Gel 1% w/ Cleanser, Metronidazole Gel 0.75%, Metronidazole Gel 0.75% w/ Cleanser
16039094|NCT02602470|Drug|Metronidazole cream|Metronidazole Cream 1%, Metronidazole Cream 0.75%, Metronidazole Cream 0.75% w/ Cleanser
16039095|NCT02602470|Drug|Metronidazole Emulsion|Metronidazole Emulsion 0.75%
16039096|NCT02602470|Drug|Metronidazole Lotion|Metronidazole Lotion 0,75%
16039097|NCT02602470|Drug|Brimonidine Tartrate Gel|Brimonidine Tartrate Gel 0.33%
16039098|NCT02602457|Behavioral|moderate-intensity continuous exercise training|Participants will complete supervised exercise sessions. Moderate-intensity continuous exercise training will follow cardiovascular rehabilitation guidelines. Participants will attend on-site moderate-intensity continuous exercise training two times weekly for 12 weeks.
16039099|NCT02602457|Behavioral|high-intensity interval training|Participants will complete supervised exercise sessions. Participants will attend on-site high-intensity interval training two times weekly for 12 weeks.
16039100|NCT02602444|Drug|ticagrelor|180 mg loading dose
16039101|NCT02602431|Device|Extra-oral laser irradiation|Irradiation will be employed extra oral by infra-red wave laser, 660nm, 100mW, and 107J/cm2 in four points of Masseter muscle for 30 seconds in each
16039102|NCT02602431|Device|Intra-oral laser irradiation|Irradiation will be employed intra oral by red wave laser, 660nm, 100mW, and 107J/cm2 in four points for 30 seconds in each : 1. Superficial face of dental socket, 2. Lingual face; 3. buccal face and 4. Retromolar region
16039103|NCT02602431|Device|Extra-oral placebo|Laser point will be placed over the same extra-oral points for 30 seconds in each point without irradiation on
16039104|NCT02602431|Device|Intra-oral Placebo|Laser point will be placed over the same intra-oral points for 30 seconds in each point without irradiation on
16039105|NCT02602418|Other|Adaptive WM CogMed Training|"12 different computerized visual and spatial Working Memory tasks will be presented at each sessoin. Each session will involve 8 of the 12 tasks, and each subject is required to complete 25 training sessions, 30-40 minutes per day, 4-5 days per week over a 5-8 week period (minimum 20 sessions). The tasks will become more difficult in an adaptive manner, which is hypothesized as optimal for learning and training effects."
16039106|NCT02602418|Other|Nonadaptive WM CogMed Training|"The same 12 computerized visual and spatial working memory tasks will be presented, but at a fixed (non-adaptive) and low difficulty level. 5 sessions per week x 5 weeks fora total of 25 sessions (minimum 20 sessions)."
16039107|NCT02602392|Behavioral|Lungtropolis|A game-based website for children with asthma aged 5-10 to teach basic self-management skills and a comprehensive adjunct informational website for parents
16039108|NCT02602392|Behavioral|Asthma educational booklet|Text-based asthma education booklet for parents and children in PDF format
16039109|NCT02602379|Other|Tetanic stimulation|Standard Tetanic stimulation will be used as the stimulus to evaluate responses of the intraoperative pain indexes (ANI and NoL) at different concentration of i.v. remifentanil during anesthesia.
16039110|NCT02602366|Other|HEC Placebo Gel|
16039111|NCT02602366|Other|Placebo Vaginal Insert|
16039112|NCT02602366|Other|Placebo Vaginal Film|
16039113|NCT02602366|Other|Placebo Intravaginal ring (IVR)|
16039114|NCT02602353|Drug|Loxoprofen Pain Patch|One Loxoprofen Pain Patch (active NSAID) applied once daily for 3 days
16039115|NCT02602353|Drug|Placebo Patch|One Placebo Patch applied daily for 3 days
16039116|NCT02602353|Drug|No Treatment|No Treatment for 3 days
16039117|NCT02602340|Behavioral|Behavioral Activation therapy|Behavioral Activation therapy
16039118|NCT02602327|Drug|Tas-102|Oral nucleoside antitumor agent consisting of α,α,α-trifluorothymidine (FTD) and 5-chloro-6-(2-iminopyrrolidin-1-yl) methyl-2,4 (1H,3H)-pyrimidinedione hydro chloride (TPI) at a molar ratio of 1:0.5.
16039119|NCT02602327|Device|SIR-Sphere|20-60mm resin microspheres containing Yttrium-90 (90Y, Y90) radioisotope
16039120|NCT02602314|Drug|Imatinib|
16039121|NCT02602314|Drug|Nilotinib|
16039122|NCT02602301|Drug|Oxytocin|different oxytocin diluents and effect on fetal bilirubin&sodium levels.
16039123|NCT02602288|Behavioral|Ask, Advise, Refer|WIC clinic staff ask about children's secondhand smoke exposure (SHSe), advise about harms of SHSe, and refer to smoking cessation resources
16039124|NCT02602288|Behavioral|Telebased tobacco counseling|Telephone counseling to promote parent's smoking cessation and behaviors to protect children from secondhand tobacco smoke
16039271|NCT02601209|Drug|Pazopanib Hydrochloride|Given PO
16039126|NCT02602288|Device|Mobile phone smoking cessation application|Smartphone based application to support smoking cessation efforts
16039127|NCT02602288|Device|Mobile phone nutrition application|Smartphone based application to support healthy eating habits
16039128|NCT02602288|Drug|Nicotine polacrilex|Over the counter nicotine replacement therapy in gum or lozenge form.
16039129|NCT02602275|Drug|Neurexan®|There are two experimental conditions; in one condition participants receive Neurexan® and the second condition they receive Placebo for oral administration (three tablets) in a cross over design. In the experimantal arm participants will receive verum on DAY1/PERIOD 1 and will receive placebo on DAY2/PERIOD 2.
16039130|NCT02602275|Other|Placebo|There are two experimental conditions; in one condition participants receive Neurexan® and the second condition they receive Placebo for oral administration (three tablets) in a cross over design. In the comparator arm participants will receive placebo on DAY1/PERIOD 1 and will receive verum on DAY2/PERIOD 2.
16039131|NCT02602262|Other|HIV-infected deceased donor organ|HIV-infected deceased donor organ transplant
16039132|NCT02602249|Biological|MUC1-gene-DC-CTL|MUC1-gene-DC-CTL will be used against tumor cells.
16039133|NCT02602249|Biological|MUC1-peptide-DC-CTL|MUC1-peptide-DC-CTL will be used against tumor cells.
16039134|NCT02602236|Device|AOS-C2000-B|1 base plate for 2 or 3 days and 1 to 4 collection special pouch per day
16039135|NCT02602223|Device|Placing Amnion chorion membrane over grafted site|Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol ACM (BioXclude, Snoasis Medical, Colorado, U.S.A were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed
16039136|NCT02602223|Device|Placing d-PTFE membrane over grafted site|Selected teeth were extracted with minimal trauma to hard and soft tissues. The extraction sites were evaluated to verify presence of intact socket walls. Sockets were thoroughly debrided and a combination of demineralized freeze-dried bone and mineralized freeze-dried bone allograft from a single lot number (Maxxeus, Ohio, U.S.A) was placed in the sockets. Per randomization protocol d-PTFE membranes (Cytoplast, Osteogenics Medical, Texas, U.S.A) were tucked into the buccal and lingual flaps, which were minimally elevated (2-3mm) and d-PTFE sutures (Osteogenics Medical, Texas, U.S.A) were used to keep membrane in place. Primary closure was not attempted and membranes were intentionally left exposed
16039137|NCT02602210|Drug|Hydrocortisone|IV bolus of 100 mg hydrocortisone in 50ml NaCl 0.9% (sodium chloride); followed by continuous IV infusion of 200 mg hydrocortisone in 50 ml NaCl 0.9% at a rate of 2 ml/h until the start of day 4.Reduction of infusion rate with 0.5 ml/h/day.
16039138|NCT02602210|Drug|NaCL 0.9%|IV bolus of 50 ml NaCL 0.9%; followed by continuous IV infusion of NaCL 0.9%
16039139|NCT02602197|Drug|Paracetamol|After anesthetic induction, the first I.V bolus injections of 1 gr paracetamol (total amount of 100 ml) were given during 15 minutes and then repeated every 6 h until 24 h postoperative period.
16039140|NCT02602197|Drug|Dexketoprofen|After anesthetic induction, the first I.V bolus injections of 50 mg Dexketoprofen (premixed with 0.9 % sodium chloride to total amount of 100 ml) were given during 15 minutes and then repeated every 8 h until 24 h postoperative period.
16039141|NCT02602184|Drug|AR/101|
16039142|NCT02602184|Drug|Placebo|
16039143|NCT02602171|Other|Oldenburger sentence test, localization test|
16039144|NCT02602158|Dietary Supplement|Octanoic acid (1-13C, 99%)|"13C-marker will be mixed with emulsions. 2 isovolumetric (200 ml) and isocaloric (200 kcal) lipid emulsions with different acid and shear stability Lipid emulsion 1: acid stable, particle size 0.6 µm
~Optional study pending interim analysis:
~Lipid emulsion 4: acid unstable, redispersible by mechanical processes during antral contractions and passage through the pylorus, particle size 0.6 µm"
16039145|NCT02602158|Dietary Supplement|TRIOCTANOIN (1,1,1-13C3, 99%)|"13C-marker will be mixed with emulsions 2 isovolumetric (200 ml) and isocaloric (200 kcal) lipid emulsions with different acid and shear stability
~Lipid emulsion 1: acid stable, particle size 0.6 µm
~Optional study pending interim analysis:
~Lipid emulsion 4: acid unstable, redispersible by mechanical processes during antral contractions and passage through the pylorus, particle size 0.6 µm"
16039146|NCT02602145|Other|follow-up CTA|All patients will receive PAD stents as their normal standard of care determined by their treating physician. If the patient would decide to enroll in the study, we will perform a standard post-operative contrast-enhanced CTA of the lower extremities at 6 months after stenting.
16039147|NCT02602132|Procedure|Clamping|To clamp before the removal of short-term indwelling urethral catheters
16039148|NCT02602119|Drug|OTL38|Infusion of OTL38 prior to surgery
16039149|NCT02602106|Behavioral|Aquatic activities intervention|Women were suggested to exercise regularly through aquatic activities. A professional in physical exercise and sports designed and conducted the aquatic exercise program.
16039150|NCT02602093|Procedure|Transforaminal Endoscopic Discectomy|Local anaesthesia is to be administered. Verification of the site to be performed by an image intensifier and depending upon the patient's posture, a line is to be drawn from the center of the herniation. The needle is to be set and position checked. After the needle has reached the correct position, a guidewire is inserted. Following that, a series of conical rods are introduced, subsequently a drill is introduced through the cannula. After drilling, the instruments are removed, but the guidewire is to remain in place. The endoscope with the working channels are introduced via an 8mm cannula. Following removal of the hernia, the cannula and endoscope are removed. The patient is to be treated on an outpatient basis.
16039151|NCT02602093|Procedure|Open Microdiscectomy|General or spinal anaesthesia is to be administered. Verification is to be performed using a Carm and the patient is to be positioned prone or in the salaam position. A paramedian incision is to be performed and the level is to be indicated. Loupe or microscope magnification is to be used. Laminotomy as well as foraminotomy is to be performed, if necessary. The amount of degenerative disc material to be removed is at the discretion of the attending surgeon. Post-operative policy will be followed and it is expected that the duration of recovery in the hospital may vary from 2-7 days, but the patient will be discharged as soon as medically responsible.
16039272|NCT02601209|Drug|Sapanisertib|Given PO
16039152|NCT02602067|Combination Product|131I-Tenatumomab|I131anti-Tenascin monoclonal antibody administered to be targeted on neoplasms expressing Tenascin-C
16039153|NCT02602054|Procedure|Surgical treatment|Standard left thoracotomy
16039154|NCT02602054|Drug|Control group|"- Indomethacin:
~Administer 1 full cycle (3 doses) / (1 dose every 12 hours) in the first fourteen days of life:
~Preterm infants less than 48 hours of life: first dose 0.2 mg/kg, second dose 0.1 mg/kg and third dose 0.1 mg/kg Preterm infants more than 48 hours of life: first dose 0.2 mg/kg, second dose 0.2 mg/kg and third dose 0.2 mg/kg And preterm infants more than 7 days of life: first dose 0.2 mg/kg, second dose 0.25 mg/kg and third dose 0.25 mg/kg - Ibuprofen:
~Administer 1 full cycle (3 doses) / (1 dose every 24 hours) in the first fourteen days of life of preterm infants:
~First dose 10 mg/kg Second dose 05 mg/kg Third dose 05 mg/kg
~- Acetaminophen
~Administer 1 full cycle, in the first fourteen days of life in preterm infants:
~Acetaminophen 15 mg/kg every 6 hours for 3 days"
16039155|NCT02602041|Other|Literature search and semi-structured interview|We will do a literature search and perform semi-structured interviews with cancer patients and their partners in order to explore knowledge, attitudes, barriers and facilitators regarding health behavior change following cancer treatment.
16039156|NCT02602028|Drug|colchicine|to compare once daily dosage schema of colchicine and twice daily dosage schema of colchicine
16039157|NCT02602002|Drug|Remifentanil|IV
16039158|NCT02602002|Drug|Placebo|Placebo
16039159|NCT02601989|Drug|Tadalafil|
16039160|NCT02601989|Drug|Placebo|Per oral intake of placebo for six weeks
16039161|NCT02601976|Drug|Peginterferon alfa-2a|PegInterferon alfa-2a 180mcg 20kDa administered subcutaneously once weekly for 24 weeks in genotype 3 and for 48 weeks in genotype 1 patients.
16039162|NCT02601976|Drug|Ribavirin|Ribavirin administered orally in a divided daily dose according to body weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
16039163|NCT02601963|Drug|FMX-103 1.5%|The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied compared to vehicle in patients with moderate-to-severe papulopustular rosacea. The foam will be applied once daily to the face for the 12-week treatment duration of the study.
16039164|NCT02601963|Drug|FMX-103 3%|The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied compared to vehicle in patients with moderate-to-severe papulopustular rosacea. The foam will be applied once daily to the face for the 12-week treatment duration of the study.
16039165|NCT02601963|Drug|Vehicle foam (0%)|The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied compared to vehicle in patients with moderate-to-severe papulopustular rosacea. The foam will be applied once daily to the face for the 12-week treatment duration of the study.
16039166|NCT02601950|Drug|Tazemetostat|Tazemetostat (EPZ-6438) is a selective small molecule inhibitor of the histone-lysine methyltransferase EZH2 gene
16039167|NCT02601937|Drug|Tazemetostat|Tazemetostat (EPZ-6438) is a selective small molecule inhibitor of the histone-lysine methyltransferase EZH2 gene.
16039168|NCT02601924|Drug|20% Benzocain (Master-Dent, Monroe, NC)|Two topical anesthetic gel groups will receive anesthetic gel at the site of injection with massage on treating tooth.
16039169|NCT02601924|Other|Topical pressure massage|Two topical pressure massage groups will receive topical placebo gel with pressure massage at the site of injection.
16039170|NCT02601911|Drug|Ketorolac Tromethamine|10 mg Ketorolac tromethamine is applied 45 minutes before the injection.
16039171|NCT02601911|Drug|Acetaminophen|10 mg Ketorolac tromethamine/ 1000mg Acetaminophen application before injection.
16039172|NCT02601911|Other|Placebo|This group receive the caplet including placebo 45 minutes before the injection.
16039173|NCT02601898|Device|Lipoic acid|Vaginal capsules (medical device) containing 10 mg of lipoic acid (1 per day)
16039174|NCT02601898|Drug|Progesterone|Vaginal capsules (drug) containing 200 mg of progesterone (2 per day)
16039175|NCT02601885|Drug|ABT-555|Intravenous Infusion
16039176|NCT02601885|Other|Placebo|Intravenous Infusion
16039177|NCT02601859|Drug|Lithium Carbonate|
16039178|NCT02601846|Other|No intervention|This is an observational study, without any specific intervention.
16039179|NCT02601833|Device|Silver Diamine Fluoride|No caries removal will take place. The tooth will be dried and Silver Diamine Fluoride will be placed on the carious dentin until saturated. Excess will be blotted dry with a cotton pellet.
16039180|NCT02601833|Procedure|Conventional Caries Management|These children will receive restorative dental care in alignment with the American Academy of Pediatric Dentistry guidelines, within the confines of the Mott Children's Health Center clinic. This treatment typically includes administration of local anesthesia, placement of rubber dam, caries removal with rotary and hand instruments, and placement of a final restoration.
16039181|NCT02601807|Device|ActiPatch (active)|Active version of the ActiPatch pulsed shortwave therapy device. Emits shortwave radiofrequency pulsed energy.
16039182|NCT02601807|Device|ActiPatch (placebo)|Placebo version of the ActiPatch pulsed shortwave therapy device. Emits no radiofrequency energy but otherwise appears identical to the active device.
16039183|NCT02601794|Behavioral|App-based Mindfulness Training|A commercially available mindfulness training app delivered to smartphone or tablet.
16039184|NCT02601781|Procedure|Primary percutaneous coronary intervention (PPCI)|Primary percutaneous coronary intervention (PPCI) aims to recanalize an occluded coronary artery causing ST-elevation myocardial infarction (STEMI).
16039185|NCT02601781|Device|Bioresorbable Vascular Scaffold (BVS ABSORB)|BVS Use during Primary PCI following a pre-specified implantation strategy (eventual thrombectomy, intravascular imaging, lesion pre-dilatation, BVS implantation and BVS post-dilatation).
16039186|NCT02601768|Device|Transcatheter closure of ASD II|Transcatheter closure of ASD II performed in our center.
16039187|NCT02601755|Behavioral|iCanCope app and website|"In addition to standard medical care, adolescents and young adults in the experimental group will receive access to the iCanCope with Pain smartphone app and website for 8 weeks. The app consists of daily pain symptom tracking (pain intensity, sleep, mood, physical activity, and fatigue), goal setting, in-the moment coping strategies, as well as a social community component. The website provides chronic pain-specific education, self-management strategies, and resources."
16039391|NCT02600520|Drug|SRP with ATV gel LDD|After SRP, 1.2% Atorvastatin (ATV) gel was delivered subgingivally into the pocket
16039188|NCT02601755|Behavioral|Attention control group|"The control group is designed to control for the potential effects on outcomes of time, attention, smartphone and computer use during the intervention. In addition to standard medical care, adolescents and young adults in the attention control group will receive access to the iCanCope with Pain smartphone app (control version, with limited functionality), and a pain resource website without access to self-management strategies."
16039189|NCT02601742|Other|Zinc group|Pedialyte diarrhea oral electrolyte solution, 330 ml per day for 7 days
16039190|NCT02601742|Other|Placebo group|Pedialyte oral electrolyte solution, 330 ml per day for 7 days
16039191|NCT02601716|Biological|PfSPZ Vaccine|Aseptic, purified, cryopreserved, radiation-attenuated, Plasmodium falciparum (Pf) sporozoites
16039192|NCT02601716|Biological|CHMI (7G8)|CHMI is conducted by exposure to the bites of five mosquitoes infected with heterologous (7G8) Pf parasites.
16039193|NCT02601716|Biological|CHMI (NF135.C10)|CHMI is conducted by exposure to the bites of three to five mosquitoes infected with heterologous (NF135.C10) Pf parasites.
16039194|NCT02601703|Drug|Tacrolimus Ointment 0.1%|apply thin layer of ointment to affected area
16039195|NCT02601703|Drug|Protopic® ointment, 0.1%|apply thin layer of ointment to affected area
16039196|NCT02601703|Drug|Placebo of Tacrolimus Ointment|apply thin layer of ointment to affected area
16039197|NCT02601690|Other|Blood Sampling|
16039198|NCT02601677|Procedure|Deep brain stimulation|Deep brain stimulation of bilateral Nucleus accumbens/Anterior Limb of Internal Capsule
16039199|NCT02601677|Drug|Fluoxetine|Fluoxetine is one of selective serotonin reuptake inhibitors(SSRIs).
16039200|NCT02601664|Procedure|Combined Intervention|pre-PCI intracoronary vasodilator administration and glycoprotein IIb/IIIa inhibitor administration, use of an embolization protection device if technically feasible, and complete coverage of the lipid core plaque, if technically feasible
16039201|NCT02601664|Procedure|Conventional PCI|Conventional PCI
16039202|NCT02601651|Drug|Lidocaine|Lignocaine group will receive an intravenous (IV) bolus 1.5 mg/kg at induction followed by continuous infusion of 2 mg/kg/hr until the tracheal extubation.
16039203|NCT02601651|Drug|Normal saline|Normal saline group will receive an intravenous normal saline bolus at induction followed by continuous infusion of normal saline until the tracheal extubation
16039204|NCT02601638|Other|Demographics and Health History Questionnaire|
16039205|NCT02601638|Other|Pre-Class Laryngectomy Survey|
16039206|NCT02601638|Behavioral|Counseling session with speech pathologist|
16039207|NCT02601638|Behavioral|Total Laryngectomy Preoperative Education Class|
16039208|NCT02601638|Other|Day of Hospital Discharge Laryngectomy Survey|
16039209|NCT02601638|Other|Day of Discharge Practicum|
16039210|NCT02601638|Other|Laryngectomy Education Study Exit Survey|
16039211|NCT02601625|Drug|Anifrolumab SC injection (300mg)|300 mg of anifrolumab delivered as 2 separate 1 mL SC injections administered serially on Day 1
16039212|NCT02601625|Drug|Anifrolumab IV infusion (300mg)|300 mg of anifrolumab delivered as an IV infusion over 30 minutes on Day 1
16039213|NCT02601625|Drug|Anifrolumab SC infusion (600mg)|600 mg of anifrolumab delivered as 4 mL SC by infusion pump on Day 1
16039214|NCT02601625|Drug|Anifrolumab placebo SC injection (300mg)|300mg of placebo delivered as 2 separate 1 mL SC injections administered serially on Day 1
16039215|NCT02601625|Drug|Anifrolumab placebo IV infusion (300mg)|600mg of placebo delivered as an IV infusion over 30 minutes on Day 1
16039216|NCT02601625|Drug|Anifrolumab placebo SC infusion (600mg)|600 mg of placebo delivered as 4 mL SC by infusion pump on Day 1
16039217|NCT02601612|Biological|D46cpΔM2-2 vaccine|Delivered as nose drops
16039218|NCT02601612|Biological|Placebo|Delivered as nose drops
16039219|NCT02601599|Behavioral|Motivational interviewing|"The medical student will deliver a brief (approximately 15 minute) consultation with the patient that is based on principles of social cognitive theory and motivational interviewing. The goals of this consultation will be to enhance the patient's motivation and self-efficacy regarding quitting, and collaboratively elicit a plan to stay quit after discharge. Patients will be offered the opportunity to receive a consultation from the attending physician to determine eligibility for pharmacotherapy (via a chart sticker).
~Each student will counsel 1-3 smokers each over the 8-month academic period, with student training and intervention staggered over this time. Students will also re-contact the smoker at 1-week post-discharge via telephone or personal follow-up, to provide further support."
16039220|NCT02601586|Drug|PR Oxycodone|PR Oxycodone
16039221|NCT02601586|Drug|Levodopa|Levodopa
16039222|NCT02601586|Drug|Oxycodone Placebo|Placebo of PR Oxycodone
16039223|NCT02601586|Drug|Levodopa placebo|
16039224|NCT02601573|Drug|Grazoprevir|GZR 100 mg is a component of the MK-5172A FDC tablet (also containing EBR 50 mg) and was taken q.d. by mouth in the morning.
16039225|NCT02601573|Drug|Elbasvir|EBR 50 mg is a component of the MK-5172A FDC tablet (also containing GZR 100 mg) and was taken q.d. by mouth in the morning.
16039226|NCT02601573|Drug|Ribavirin|RBV 200 mg capsules taken b.i.d. (morning and evening) by mouth at a total daily dose ranging from 800 mg to 1400 mg (total daily dose was based on participant body weight).
16039227|NCT02601573|Drug|Sofosbuvir|SOF 400 mg tablet taken q.d. by mouth in the morning with food.
16039228|NCT02601560|Biological|MEDI6012|Participants received a single IV (24, 80, 240, and 800 mg) and SC (80 and 600 mg) MEDI6012 doses on Day 1.
16039229|NCT02601560|Biological|Placebo SC|Participants received a single SC dose of placebo matched to MEDI6012 on Day 1 of the study.
16039230|NCT02601560|Biological|Placebo IV|Participants received a single IV dose of placebo matched to MEDI6012 on Day 1 of the study.
16039231|NCT02601547|Device|PET-FDG brain imaging and NPT|PET-FDG brain imaging and NPT should be performed at T0, at Tf (within 1 month after chemotherapy termination), T+12. Several PET parameters should be calculated: minimal SUV (Standard Uptake Value), maximum SUV, and mean SUV for each of 20 cortical and sub-cortical territories.
16039232|NCT02601534|Behavioral|Zero-time Exercise|a knowledge and motivation enhancement session at baseline, an experience sharing session at 3 months, a family gathering session at 6 months, and a holistic health session at 12 months (not a part of cRCT, for the collection of feedback only) as well as biweekly/monthly mobile messages to improve physical activity habit.
16039434|NCT02600130|Biological|Longeveron Mesenchymal Stem Cells|via peripheral intravenous infusion
16039233|NCT02601534|Behavioral|Healthy Eating|a knowledge and motivation enhancement session at baseline, an experience sharing session at 3 months, a family gathering session at 6 months, and a holistic health session at 12 months (not a part of cRCT, for the collection of feedback only) as well as biweekly/monthly mobile messages to improve dietary habit.
16039234|NCT02601521|Behavioral|Internal tobacco coach|"The internal coaching program will provide cognitive-behavioral counseling and medication adherence support for smokers who are ready to quit in the next 3 months It consists of:
~Telephone counseling by the Tobacco Coach (8 calls over 12 weeks). supplemented by automated phone calls using interactive voice response. At each IVR contact, smokers can request a call back from the Tobacco Coach. Smokers who are not quit after 3 months can restart into the 12-week counseling program.
~The Tobacco Coach will assist smokers in choosing pharmacotherapy and in obtaining a prescription from the smoker's physician.
~Support and monitoring for 12 months using automated phone calls. If relapse occurs, the smoker will have the option to return to the active 12-week program."
16039235|NCT02601521|Behavioral|External tobacco coach|Referral to Massachusetts Smokers Helpline (telephone quitline operated by the Massachusetts Tobacco Control Program) for proactive telephone counseling.
16039236|NCT02601508|Drug|Rocuronium|Continuous infusion of rocuronium for PTC 1 + Sugammadex
16039237|NCT02601508|Drug|cis-atracurium|Intermittent injection of cis-atracurium for TOF 1 + Pyridostigmine & Glycopyrrolate
16039238|NCT02601495|Behavioral|Women in a court diversion program|Women in Recovery (WIR) is an intensive outpatient alternative for eligible women facing long prison sentences for non-violent, drug-related offenses in Oklahoma.
16039239|NCT02601482|Behavioral|CON|
16039240|NCT02601482|Behavioral|IW-60|
16039241|NCT02601482|Behavioral|IW-45|
16039242|NCT02601469|Drug|DSXS|twice daily for 28 days
16039243|NCT02601443|Device|Cervical Pessary|
16039244|NCT02601430|Other|BOLD-MRI|A fixed air cuff will be placed on the index limb at the level of the calf and will be inflated to a level which induces the loss of the pedal Doppler signal. Inflation will be maintained for 180 seconds, then will be rapidly deflated and BOLD MR imaging will be initiated.
16039245|NCT02601417|Other|Ignoring result of bile culture|Patients in the trial arm will do bile cultures which will not be considered when choosing antibiotics.
16039246|NCT02601404|Device|Bioresorbable scaffold (BRS)|The implantation procedure of an Absorb™ is similar to a metallic stent.
16039247|NCT02601391|Behavioral|Adapting STEPPS within forensic inpatient services.|This study will focus upon delivering the STEPPs-HI group within Forensic Healthcare Inpatient Services.
16039248|NCT02601378|Drug|LXS196|LXS196 as a single agent
16039249|NCT02601378|Drug|LXS196 and HDM201|LXS196 in combination with HDM201
16039250|NCT02601365|Drug|Sargramostim 0.04 mcg/kg/dose|The final dilution of sargramostim will occur at the bedside by a study team member. Cohort 1 will receive sargramostim 0.04 mcg/kg/dose nebulized to the inspiratory loop of the patients' mechanical ventilator circuit for 15 minutes.
16039251|NCT02601365|Drug|Sargramostim 0.2mcg/kg/dose|The final dilution of sargramostim will occur at the bedside by a study team member. Cohort 1 will receive sargramostim 0.2 mcg/kg/dose nebulized to the inspiratory loop of the patients' mechanical ventilator circuit for 15 minutes.
16039252|NCT02601365|Drug|Sargramostim 1 mcg/kg/dose|The final dilution of sargramostim will occur at the bedside by a study team member. Cohort 1 will receive sargramostim 1 mcg/kg/dose nebulized to the inspiratory loop of the patients' mechanical ventilator circuit for 15 minutes.
16039253|NCT02601339|Procedure|ETV/CPC|endoscopic third ventriculostomy (ETV) combined with choroid plexus cauterization (CPC) is a surgical procedure to treat infant hydrocephalus
16039254|NCT02601326|Procedure|Laparoscopic ventral mesh Rectopexy|Laparoscopic fixation of rectum to sacral promontory using mesh
16039255|NCT02601326|Procedure|Delorme's procedure|Transanal excision of rectal mucosa and plication of muscle layer
16039256|NCT02601313|Biological|brexucabtagene autoleucel|A single infusion of brexucabtagene autoleucel (KTE-X19) anti-CD 19 CAR T cells
16039257|NCT02601313|Drug|Cyclophosphamide|Administered intravenously
16039258|NCT02601313|Drug|Fludarabine|Administered intravenously
16039259|NCT02601313|Drug|Axicabtagene Ciloleucel|A single infusion of axicabtagene ciloleucel anti-CD 19 CAR T cells
16039260|NCT02601300|Drug|GED-0301|
16039261|NCT02601287|Biological|Botulinum Toxin Type A|Botulinum Toxin Type A into detrusor muscle on Day 1
16039262|NCT02601274|Drug|Theliatinib|Theliatinib is a tablet in the form of 25 mg ,10mg and 100 mg,oral,once daily
16039263|NCT02601261|Other|At the first day of hospitalization the field investigator will submit to pregnant women in a pathological condition five questionnaires|"Some of these questionnaires will have to be completed every day and others every other day:
~The Internet questionnaire is divided in two parts. The first one investigates the use of internet at home and it will be administered only once, the second part will investigate the internet use at the hospital, in the case the women have a personal smartphone, tablet or personal computer (they are the owners) and it will be administered every other days.
~The questionnaire is aimed to understand the quality of life (EQ-5D) will be administered only once, at the beginning of the hospitalization.
~The STAI questionnaire is divided in to parts, the first part aims to determinate the state anxiety and it will be administered every other day, while the second part will discuss the anxiety itself, and has to completed only once.
~The short questionnaire on critical events occurring during the day,
~The short questionnaire with obstetric anamnesis."
16039264|NCT02601248|Drug|Theliatinib|Theliatinib is a tablet in the form of 25 mg ,10mg and 100 mg,oral,once daily
16039265|NCT02601235|Drug|Naridrin|Naridrin® : 2 drops in each nostril once daily as prescription
16039266|NCT02601235|Drug|Afrin|2 pumps in each nostril every 12 hours.
16039267|NCT02601222|Drug|Runzao zhiyang capsule|Runzao zhiyang capsule：4 pills each time, 3 times a day, oral. Number of Cycles：4 weeks of treatment, the cured patients were followed up for 8 weeks to evaluate recurrence.
16039268|NCT02601222|Drug|Runzaozhiyang capsule agent simulation|Runzaozhiyang capsule agent simulation：4 pills each time, 3 times a day, oral， Number of Cycles：4 weeks of treatment, the cured patients were followed up for 8 weeks to evaluate recurrence.
16039269|NCT02601222|Drug|Urea cream|Topical application, apply to the affected area and gently rub, 2 times a day.Number of Cycles：4 weeks of treatment, the cured patients were followed up for 8 weeks to evaluate recurrence.
16039270|NCT02601209|Drug|Pazopanib|Given PO
16039273|NCT02601196|Drug|Ulipristal acetate|"Transvaginal US and diagnostic hysteroscopy - to ascertain suitability. A therapeutic course of ulipristal acetate 5 mg per day for 13 weeks. After completion of the treatment protocol - another TVUS, diagnostic hysteroscopy and histological examination of the endometrium - to assess results of UPA treatment.
~Another IVF cycle."
16039274|NCT02601170|Biological|Platelet-Rich Plasma Intra-Articular Injection|
16039275|NCT02601170|Drug|Hyaluronic Acid Viscosupplementation|
16039276|NCT02601157|Device|CX-ISAR|Patients with significant coronary lesions will be treated with this contemporary stent platform. This stent platform has a thin-strut cobalt-chromiun alloy backbone, no polymer, microporous surface.
16039277|NCT02601157|Device|Orsiro|Patients with significant coronary lesions will be treated with this contemporary stent platform. This stent platform has a thin-strut cobalt-chromiun alloy backbone, abluminal coatings with biodegradable polymer.
16039278|NCT02601157|Drug|3-months DAPT|Contrast to the conventional 1-year DAPT, patients in this group will be followed with 3-months DAPT schedule after the stenting
16039279|NCT02601157|Drug|1-year DAPT|Patients in this group will be followed with the conventional 1-year DAPT schedule after the stenting
16039280|NCT02601144|Device|Deep Brain Stimulation|Deep Brain Stimulation
16039281|NCT02601131|Biological|Platelet transfusion|
16039282|NCT02601118|Other|Micro Expression Training Tool|The Micro Expression Training Tool (METT) and the Subtle Expression Training Tool (SETT) to help improve the non-verbal communication skills
16039283|NCT02601105|Other|Placebo Vehicle Cream|Lipoderm Cream alone
16039284|NCT02601105|Other|Centella Asiatica Cream|1% Centella Asiatica in lipoderm
16039285|NCT02601092|Procedure|Mini Gastric Bypass|"The mini gastric bypass procedure was first developed by Dr Robert Rutledge from the USA in 1997, as a modification of the standard Billroth II procedure. A mini gastric bypass creates a long narrow tube of the stomach along its right border (the lesser curvature). A loop of the small gut is brought up and hooked to this tube at about 180 cm from the start of the intestine.
~No drugs or devices will be used."
16039286|NCT02601092|Procedure|Roux-en-Y Gastric Bypass|"This variant is the most commonly employed gastric bypass technique, and is by far the most commonly performed bariatric procedure in the United States. The small intestine is divided approximately 45 cm (18 in) below the lower stomach outlet and is re-arranged into a Y-configuration, enabling outflow of food from the small upper stomach pouch via a Roux limb. In the proximal version, the Y-intersection is formed near the upper (proximal) end of the small intestine. The Roux limb is constructed using 80-150 cm (31-59 in) of the small intestine, preserving the rest (and the majority) of it for absorbing nutrients.
~No drugs or devices will be used."
16039287|NCT02601079|Device|Endodrill Biopsy|Testing a new device for taking tissue biopsies in the GI tract. The investigators will use the Endodrill instrument in order to sample high quality biopsies from tumor tissue in the distal esophagus and cardia. The investigators will also investigate to what extent the Endodrill instrument can generate biopsies with the correct diagnosis and also evaluate the possibility for genetic studies of the harvested tumor tissue.
16039288|NCT02601079|Device|Conventional Biopsy forceps|Using a conventional biopsy forceps for taking tissue biopsies in the GI tract. The investigators will use conventional biopsy forceps in order to sample high quality biopsies from tumor tissue in the distal esophagus and cardia. The investigators will also investigate to what extent the conventional biopsy forceps can generate biopsies with the correct diagnosis and also evaluate the possibility for genetic studies of the harvested tumor tissue.
16039289|NCT02601066|Device|Electrophysiological Study and ECG holter monitor|Electrophysiological Study and ECG holter monitor implantation
16039290|NCT02601053|Other|Dull movie|A dull movie (duration approximately 90 minutes)
16039291|NCT02601053|Other|Scary (horrifying) movie|A scary movie (duration approximately 90 minutes)
16039292|NCT02601053|Other|Heart rate measurement|Heart rate measurement using a actiheart device
16039293|NCT02601040|Biological|Attenuated Hepatitis A Vaccine, H2 Strain|6.50 lgCCID50/ml in babies aged 18-35 months\6.50 lgCCID50/ml in children aged 3-16 years \6.50 lgCCID50/ml in adults aged 17 up to 65 years old
16039294|NCT02601040|Biological|Inactivated Hepatitis A Vaccine, Lu8 Strain|320EU/Vial in babies aged 18-35 months \320EU/Vial in children aged 3-16 years \640EU/Vial in adults aged 17 up to 65 years old\boost at month 6\two-dose
16039295|NCT02601040|Biological|Group A Meningococcal Polysaccharide vaccine|30µg Group A Meningococcal Polysaccharide vaccine in subjects aged 18 months-65 years old
16039296|NCT02601027|Procedure|Transversus Abdominis Plane (TAP) block|
16039297|NCT02601027|Device|Nimbus Infusion Pump IV Administration|
16039298|NCT02601027|Drug|Bupivacaine infusion|
16039299|NCT02601027|Drug|Acetominophen|
16039300|NCT02601027|Drug|Hydromorphone|
16039301|NCT02601027|Drug|Oxycodone|
16039302|NCT02601027|Drug|Ondansetron|
16039303|NCT02601014|Biological|Ipilimumab|Given IV
16039304|NCT02601014|Other|Laboratory Biomarker Analysis|Correlative studies
16039305|NCT02601014|Biological|Nivolumab|Given IV
16039306|NCT02601001|Drug|Omecamtiv mecarbil|Omecamtiv mecarbil tablets for oral administration
16039307|NCT02601001|Drug|Placebo|Matching placebo tablets
16039308|NCT02600988|Drug|1000IU/day of Vitamine D|Administration of a specified dose of Vitamine D
16039309|NCT02600988|Drug|5000IU/day of Vitamine D|Administration of a specified dose of Vitamine D
16039310|NCT02600975|Biological|R21 with ASO1B|R21 with ASO1B
16039311|NCT02600949|Drug|Imiquimod|Applied topically
16039312|NCT02600949|Other|Laboratory Biomarker Analysis|Correlative studies
16039313|NCT02600949|Biological|Pembrolizumab|Given IV
16039314|NCT02600949|Biological|Synthetic Tumor-Associated Peptide Vaccine Therapy|Given SC
16039315|NCT02600936|Device|vein stent placement|Venous outflow obstruction will be treated by the placement of a stent to keep the vein open. This procedure is a minimally invasive endovascular treatment.
16039316|NCT02600923|Drug|Palbociclib|Palbociclib will be administered orally once a day at 125 mg/day for 21 days followed by 7 days off treatment for each 28-day cycle (Schedule 3/1).
16039317|NCT02600923|Drug|Letrozole|Letrozole will be administered orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information.
16039318|NCT02600897|Drug|Lenalidomide|All participants will receive lenalidomide oral capsules at doses of 10, 15, or 20 milligrams (mg) on Days 1 to 21 of each 28-day cycle for up to 6 Cycles in dose escalation phase followed by post-induction treatment at a dose of 10 mg once daily on Days 1 to 21 of each subsequent 28-day cycle. Post-induction lenalidomide may continue for up to 12 months until disease progression or unacceptable toxicity for participants with R/R FL and up to 6 months until disease progression or unacceptable toxicity for participants with R/R DLBCL.
16039319|NCT02600897|Drug|Obinutuzumab|Participants will receive a fixed dose of obinutuzumab, 1000 mg via intravenous (IV) infusion to be given on Days 1, 8 and 15 of Cycle 1 and on Day 1 of Cycles 2 to 6 followed by post-induction treatment at a dose of 1000 mg via IV infusion on Day 1 of every other month for up to 24 months until disease progression or unacceptable toxicity.
16039320|NCT02600897|Drug|Polatuzumab Vedotin|Participants with R/R FL will receive polatuzumab vedotin via IV infusion at doses of 1.4 or 1.8 milligrams per kilogram (mg/kg) on Day 1 of each 28-day cycle for up to 6 months during induction treatment. Participants wit R/R DLBCL will receive polatuzumab vedotin via IV infusion at dose 1.8 mg/kg on Day 1 of each 28-day cycle for up to 6 months during induction treatment.
16039321|NCT02600897|Drug|Rituximab|Participants will receive a fixed dose of rituximab, 375 mg/m^2 via intravenous (IV) infusion to be given on Days 1 of Cycle 1 to 6 followed by post-induction treatment at a dose of 375 mg/m^2 via IV infusion on Day 1 of every other month for up to 6 months, until disease progression or unacceptable toxicity.
16039322|NCT02600884|Behavioral|Families Talking Together Plus (FTT+HPV)|Intervention parents will attend a 1-hour intervention session and receive program materials to use with youth at home and 2 booster phone calls post intervention. Content of the experimental intervention includes parent child sexual health communication and HPV vaccination navigation.
16039323|NCT02600884|Behavioral|Brief motivational interviewing (BMI)|Control parents will attend a 1-hour intervention session and receive program materials to use with youth at home and 2 booster phone calls post intervention. Content of the control intervention includes obesity prevention strategies using motivational interviewing.
16039324|NCT02600871|Drug|Provodine|
16039325|NCT02600871|Procedure|Incision and Drainage|
16039326|NCT02600858|Behavioral|Upper limb feeding training|"Participants will spoon two raw kidney beans at a time from a center proximal start cup to three distal target cups positioned 16 cm away at 45°, 90° and 135° around the start cup as fast as possible using their non-dominant hand. Spooning two beans between the start cup and a target cup is considered one repetition; each trial will consist of 15 repetitions. Participants will perform 50 trials per day for 3 consecutive days."
16039327|NCT02600845|Device|ACCU-CHEK|ACCU-CHEK Connect Diabetes Management System contains ACCU-CHEK Aviva Connect Blood Glucose Monitoring System, ACCU-CHEK Connect Diabetes Management App, and ACCU-CHEK Connect Online Diabetes Management System.
16039328|NCT02600832|Behavioral|AABM Training|The investigators will use a training version of the Alcohol Approach-Avoidance Task (AAT), in which patients are asked to respond to the format of presented pictures, irrespective of the pictures' content. Pushing a presented picture away will decrease picture size, whereas pulling a picture closer will increase size. There are 2 categories of pictures; 20 different alcoholic and 20 different non-alcoholic beverages. Training effect is achieved by presenting alcohol pictures in push format only and non-alcoholic drinks in pull format only. Two hundred training trials are presented per session.
16039329|NCT02600832|Behavioral|Sham Training|Sham training is identical to AABM training, except pictures are presented randomly in both formats.
16039330|NCT02600819|Drug|E/C/F/TAF|150/150/200/10 mg FDC tablets administered orally once daily
16039331|NCT02600819|Drug|B/F/TAF|50/200/25 mg FDC tablets administered orally once daily
16039332|NCT02600806|Drug|Azithromycin|Patients are given oral azithromycin when procalcitonin levels are < 0.5 ng/ml
16039333|NCT02600806|Drug|Levofloxacin|Patients are given oral levofloxacin when procalcitonin levels are >= 0.5 ng/ml.
16039334|NCT02600793|Drug|Ceftaroline|Following Ceftaroline single IV dose, 3 blood and cerbrospinal fluid samples will be collected
16039335|NCT02600780|Drug|Febuxostat|Comparison of two anti-hyperuricemic molecules
16039336|NCT02600780|Drug|Allopurinol|Comparison of two anti-hyperuricemic molecules
16039337|NCT02600767|Drug|Artemether-lumefantrine combination|This is the sole arm in this study and it is the use of the standard combination therapy for treatment of P. falciparum malaria.
16039338|NCT02600754|Behavioral|IT-PST|5 sessions of problem-solving therapy by licensed mental health clinicians co-located in an aging-service agency (Meals on Wheels and More)
16039339|NCT02600754|Behavioral|IT-SCM|5 sessions of self-care management support by trained lay advisers co-located in an aging-service agency (Meals on Wheels and More)
16039340|NCT02600741|Other|Caregiver psycho-education and skills training|Caregivers will receive up to 16 sessions of study-provided caregiver psycho-education and skills training sessions they are able to attend within a 6-month period.
16039341|NCT02600741|Other|Caregiver support available at the study site|Caregivers will receive whatever caregiver support that is customarily available at the study site, if any.
16039342|NCT02600741|Drug|Paliperidone palmitate|Patients enrolled in this study will continue to receive routine treatment of paliperidone palmitate, as directed by their treating physician.
16039343|NCT02600741|Drug|Chlorpromazine|Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
16039344|NCT02600741|Drug|Droperidol|Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
16039345|NCT02600741|Drug|Fluphenazine|Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
16039346|NCT02600741|Drug|Haloperidol|Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
16039347|NCT02600741|Drug|Loxapine|Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
16039348|NCT02600741|Drug|Perphenazine|Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
16039349|NCT02600741|Drug|Pimozide|Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
16039350|NCT02600741|Drug|Prochlorperazine|Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
16039351|NCT02600741|Drug|Thiothixene|Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
16039352|NCT02600741|Drug|Thioridazine|Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
16039353|NCT02600741|Drug|Trifluoperazine|Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
16039354|NCT02600741|Drug|Aripiprazole|Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
16039355|NCT02600741|Drug|Asenapine|Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
16039356|NCT02600741|Drug|Clozapine|Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
16039357|NCT02600741|Drug|Iloperidone|Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
16039358|NCT02600741|Drug|Olanzapine|Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
16039359|NCT02600741|Drug|Paliperidone|Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
16039360|NCT02600741|Drug|Quetiapine|Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
16039361|NCT02600741|Drug|Risperidone|Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
16039362|NCT02600741|Drug|Ziprasidone|Patients enrolled in this study will continue to receive routine treatment of oral antipsychotics, as directed by their treating physician.
16039363|NCT02600728|Behavioral|Experimental Training|"The ET consisted of 3 phases being that the first one (Phase 1) was done only in the first session.
~Phase 1: patients received a short and simple explanation about the deficiency in automatic movement resulting from PD. Following explanation, the patient memorized a sequence of declarative cues. Phase 2: the patient organized a sequence of cues using cards illustrating the subcomponent movements (key movement) involved in taking steps.
~Phase 3: the patient had to train using declarative cues as a gait performance aid through 8 sets follow the instruction Walk in your ordinary speed. Use the key movements and going to saying each of them while you make them. The declarative cues had to be evoked verbally by the patients themselves, during gait, triggering the corresponding movement."
16039364|NCT02600728|Behavioral|Control Training|"The CT consisted of 3 phases, being the first one (Phase 1) was done only in the first session of training, and the other two (Phase 2 and 3) were repeated at each of the 8 sessions.
~Phase 1: Patients received a short and simple explanation about the deficiency in automatic movement resulting from PD.
~Phase 2: Patients received a general verbal attentional instruction of pay attention to your steps and try to walk as better as you can, before starting the walk.
~Phase 3: motor training of gait, where the patient had to perform 8 sets, following the instruction Walk in your ordinary speed, paying attention to your steps in the identical trajectories of ET. Additional instructions or cues were not provided."
16039365|NCT02600715|Drug|Onabotulinumtoxin A (BoNT)|
16039366|NCT02600715|Drug|belladonna|Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg.
16039367|NCT02600715|Drug|Morphine|Part of dosage of the compounded active B&O suppository of belladonna 16.2mg and morphine 7.5mg.
16039368|NCT02600715|Drug|Placebo|matching placebo to B&O suppository
16039369|NCT02600715|Drug|Active B&O suppository of belladonna|belladonna 16.2mg and morphine 7.5mg
16039370|NCT02600702|Other|Siriraj knee exercise|Siriraj knee exercise, 12 position of exercise protocol
16039371|NCT02600702|Other|Physical modalities|
16039372|NCT02600689|Behavioral|Physical exercise training|
16039373|NCT02600689|Behavioral|Cognitive exercise training|
16039374|NCT02600676|Device|Transcutaneous Electric Nerve Stimulation (TENS) - active|TENS is a non-invasive method using surface electrodes. Except a few cases with local skin irritation in the area where the electrodes are applied, there is no evidence of side effects of TENS treatment.
16039375|NCT02600676|Device|Transcutaneous Electric Nerve Stimulation (TENS) - placebo|
16039376|NCT02600650|Dietary Supplement|Testosterone boosting supplement|Proprietary formulation of Testosterone boosting supplement administered daily
16039377|NCT02600650|Dietary Supplement|Placebo Comparator|Daily administration of Placebo Comparator
16039378|NCT02600637|Behavioral|MBSR|Mindfulness-based Stress Reduction is an 8-week course designed to teach a number of mindfulness techniques to help improve stress- and depression-related symptoms.
16039379|NCT02600637|Behavioral|Brain Health class|An 8-week course on brain health will be administered to participants as an active control group.
16039380|NCT02600611|Drug|iclaprim|Experimental treatment
16039381|NCT02600611|Drug|vancomycin|Active comparator
16039382|NCT02600598|Drug|LEO 43204 Gel, 0.037%|
16039383|NCT02600598|Drug|LEO 43204 Gel, 0.037%|
16039384|NCT02600585|Biological|Recombinant Influenza Vaccine|Intramuscular injection of study vaccine
16039385|NCT02600585|Biological|Inactivated Influenza Vaccine|Intramuscular injection of study vaccine
16039386|NCT02600572|Other|Isometric exercises|Subjects will perform one session of isometric exercises at the end of Day 1
16039387|NCT02600572|Other|Eccentric exercises|Subjects will perform one session of eccentric exercises at the end of Day 2
16039388|NCT02600559|Drug|OTO-201 (ciprofloxacin)|
16039389|NCT02600533|Procedure|Video viewing group|First, participants will complete a brief electronic survey measuring their opinions on clinical trials. Next, participants in the video viewing group will watch the 10-minute DVD video on tablet devices using headphones in the clinic. Participants in this groups will be informed that a team member will call him/her in approximately 1 week to ask him/her the (same) questions about clinical research.
16039390|NCT02600520|Drug|SRP with RSV gel LDD|After SRP, 1.2% Rosuvastatin (RSV) gel was delivered subgingivally into the pocket
16039392|NCT02600520|Drug|SRP with placebo gel LDD|After SRP, placebo gel was delivered subgingivally into the pocket
16039393|NCT02600507|Drug|ITI-007|
16039394|NCT02600507|Drug|Placebo|
16039395|NCT02600494|Drug|ITI-007 (Lumateperone)|
16039396|NCT02600494|Drug|Placebo|
16039397|NCT02600481|Procedure|low-pressure pneumoperitoneum|Using low-pressure(between 7-10 mm Hg ) pneumoperitoneum to complete robot-assisted surgeries,such as radical prostatectomy or cystectomy.
16039398|NCT02600481|Procedure|standard-pressure pneumoperitoneum|Using standard-pressure (between 12-16 mm Hg )pneumoperitoneum to complete robot-assisted surgeries,such as radical prostatectomy or cystectomy.
16039399|NCT02600468|Drug|Orencia|
16039400|NCT02600455|Drug|Orencia|
16039401|NCT02600442|Other|non interventional study|
16039402|NCT02600429|Drug|RGN-259|A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into affected eye(s), five times a day for 4 weeks.
16039403|NCT02600429|Drug|Placebo|It is composed of the same excipients as RGN-259 but does not contain Tβ4
16039404|NCT02600416|Other|AV port reversal|Reversal of the AV port at 1h Reversal of the AV port to start position at 7h
16039405|NCT02600403|Diagnostic Test|Optical Coherence Tomography (OCT)|Optical Coherence Tomography (OCT) is a machine that scans eyes and has the capability of measuring thickness of various layers of the retina and nerve fiber layer (NFL).
16039406|NCT02600403|Diagnostic Test|Visual evoked potential (VEP)|Visual Evoked Potential (VEP) is an imaging system that measures electrical activity from the eye to the brain by using electrodes placed on forehead and back of the head similar to electroencephalogram (EEG).
16039407|NCT02600403|Diagnostic Test|Humphrey Visual Field (HVF)|Humphrey Visual Field (HVF) is a test done to evaluate how much peripheral (side) vision has been lost due to glaucoma.
16039408|NCT02600390|Biological|SANGUINATE|A two-hour infusion provided once a week over a 4-week or 6-week period.
16039409|NCT02600377|Other|Vegetarian diet|Diets that omit all animal products (vegan diet) or all animal products with the exception of eggs and/or dairy products (vegetarian)
16039410|NCT02600351|Drug|LDV/SOF|90/400 mg FDC tablet administered orally once daily
16039411|NCT02600351|Drug|RBV|Tablets administered orally in a divided daily dose according to weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16039412|NCT02600338|Other|Legumes|beans, peas, chickpeas, lentils, soybeans, lupins, peanuts in whole or flour form
16039413|NCT02600325|Drug|Grazoprevir/Elbasvir 100mg/50mg|Grazoprevir/Elbasvir 100mg/50mg
16039414|NCT02600312|Device|oXiris|oXiris CRRT filter which adsorbs cytokines, toxins.
16039415|NCT02600299|Behavioral|Psychoeducation group|On the basis of previous studies that evaluated PEG interventions for women with breast cancer, a structured program based on the Cognitive Behavioral Therapy (CBT) principles was developed. Patients in the PEG group will be involved in three sessions of psychoeducation. The PEG program is designed to cover the various aspects outlined by the IOM on quality cancer survivorship.
16039416|NCT02600299|Behavioral|Usual Care|Usual Care
16039417|NCT02600286|Drug|EllaOne|"5 mg/per os of EllaOne every day through 12 months.
~10 mg/per os of EllaOne every day through 12 months.
~EllaOne placebo/per os every day through 12 months."
16039418|NCT02600286|Drug|EllaOne placebo|"5 mg/per os of EllaOne every day through 12 months.
~10 mg/per os of EllaOne every day through 12 months.
~EllaOne placebo/per os every day through 12 months."
16039419|NCT02600273|Other|Usual brand cigarettes|Usual brand cigarettes
16039420|NCT02600273|Other|Lower nicotine content cigarettes|SPECTRUM research cigarettes
16039421|NCT02600273|Other|Electronic cigarettes 1|Electronic cigarette with 0 g/mL e-liquid
16039422|NCT02600273|Other|Electronic cigarettes 2|Electronic cigarette with 18 g/mL e-liquid
16039423|NCT02600260|Drug|Enoxaparin|Patients who score higher or equal to 3, receive a prophylactic dose of enoxaparin. The first dose of enoxaparin is administered 8 hours after vaginal or abdominal delivery. Subsequent doses are administered daily for up to 15 days. The dose depends on patient weight.
16039424|NCT02600260|Other|No intervention|Hospitalized patients that score less than three are not prescribed enoxaparin.
16039425|NCT02600247|Drug|Duloxetine|"Experimental: Duloxetine group
~Phase I (preemptive): 1day before operation (30mg for 1 day)
~Phase II (maintenance): 6weeks after operation (30mg for 6 weeks) plus routine pain control (celecoxib, pregabalin, acetaminophen/tramadol, oxycodone)
~Other Name: cymbalta Drug: Celebrex, Lyrica, Ultracet, Ircodon
~Preemptive analgesia : celebrex 200mg 1C#1, Lyrica 150mg 1C#1 (preoperation. 2 hours), Patient controlled analgesia (postoperation 28 hours) During admission : celebrex 200mg#1, Ircodon 5mg 2T#2, Ultracet 2T#2 (Postoperation 1 week) Discharge medication: celebrex 200mg 1C#1 x 5Weeks, Ultracet 2T#2 x 1 week
~Other name : celecoxib, Pregabalin, acetaminophen/tramadol, oxycodone"
16039426|NCT02600247|Drug|celecoxib, Pregabalin, acetaminophen/tramadol, oxycodone|"Preemptive analgesia : celebrex 200mg 1C#1, Lyrica 150mg 1C#1 (preoperation. 2 hours), Patient controlled analgesia (postoperation 28 hours) During admission : celebrex 200mg#1, Ircodon 5mg 2T#2, Ultracet 2T#2 (Postoperation 1 week) Discharge medication: celebrex 200mg 1C#1 x 5Weeks, Ultracet 2T#2 x 1 week
~Other name : celecoxib, Pregabalin, acetaminophen/tramadol, oxycodone"
16039427|NCT02600234|Device|Inter-Atrial Shunt Device|An implantable device placed in the interatrial septum
16039428|NCT02600234|Other|Intracardiac Echo|Patients randomized to the control arm will undergo intra cardiac echocardiography, with examination of the atrial septum and left atrial appendage.
16039430|NCT02600195|Behavioral|Evidence-based Practice for Improving Quality (EPIQ) method|The intervention NICUs (n = 12) will receive training in the Evidence-based Practice for Improving Quality (EPIQ) method and then develop, implement, and document evidence-based practice changes to reduce hospital-acquired infection. Compliance with practice changes and neonatal outcomes will be monitored. NICUs will receive quarterly feedback on their progress, as well as access to implementation support.
16039431|NCT02600182|Device|Bilevel Positive Airway Pressure|Bilevel positive airway pressure twice per day during the hospital stay.
16039432|NCT02600169|Drug|Pemprolizumab|All patients in this study have received treatment with pembrolizumab for the indication of an advanced melanoma.
16039433|NCT02600156|Procedure|Focal laser ablation of the prostate|MR guided laser ablation of the focal prostatic lesion which has been identified by MRI and biopsy prior to ablation.
16039437|NCT02600104|Device|PicoWayTM|The PicoWayTM base unit using a single, free-running, flashlamp-pumped alexandrite laser as a pump source for both the oscillator and the amplifier
16039438|NCT02600091|Behavioral|Mindfulness-Based Cognitive Therapy|The MBCT intervention is manualised and delivered to groups. The aim of the MBCT intervention is to increase mindfulness skills and to facilitate their use in relation to emotional wellbeing and diabetes self-management. Participants will attend on 8 occasions, once per week, for 2 hours. These meetings will have a standard structure. First, participants will describe their efforts to practice mindfulness at home over the previous week, followed by discussion of an educational topic relevant to the aims of the course. Finally, the group will do a mindfulness practice together, and the home practice for the following week will be set. In-between meetings, participants are asked to practice mindfulness by listening to an audio file or CD for about 30 minutes per day.
16039439|NCT02600078|Device|AMS Monitor App|Participants will complete a novel coordination task performed on an android phone.
16039440|NCT02600078|Other|Lake Louise Score|Participants will complete a questionnaire to assess acclimatization to hypoxia.
16039441|NCT02600078|Other|Balance Error Scoring System|Participants will complete a series of static stance positions to evaluate their ability to maintain balance.
16039442|NCT02600078|Other|Heart Rate & Pulse Oxygen Saturation|Participants will have their heart rate and pulse oxygen saturation continuously monitored throughout the entire exposure.
16039443|NCT02600065|Other|Blood draw and MRI|The study is observational. The treatment-plan of the underlying disease remained unchanged. Blood draw and MRI from patients at several time points during and after radio(chemo)therapy.
16039444|NCT02600052|Other|PNF|RESPIRATORY PATTERN PROPRIOCEPTIVE NEUROMUSCULAR FACILITATION
16039445|NCT02600052|Device|treadmill|AEROBIC TRAINING
16039446|NCT02600039|Other|ELTGOL|Individuals will be placed in the lateral decubitus position and instructed to perform slow expirations with an open glottis through a nozzle attached to the mouth from the residual functional capacity to residual volume. Concurrently, a trained and subsequently positioned relative to the voluntary physical therapist will perform a manual compression of the abdominal region dependent and the rib cage to enhance contralateral lung deflation. This intervention is performed so that the time is homogeneous between each repetition interval of one minute between each set. To this end, three sets of ten repetitions will be performed on each lateral decubitus (left and right)
16039447|NCT02600039|Device|Acapella|Participant should be comfortably seated and with his elbows on a table. The mouthpiece is attached properly to not allow leaks. The resistance load will be one in which the individual is able to maintain uninterrupted expiration of 3 seconds. Then the patient will be instructed to inhale slowly and deeply, with lung volumes between the residual volume and total lung capacity. The air exhaled by Acapella is directed toward an orifice which opens and closes periodically, promoting oscillations in the air stream throughout the expiratory phase. The expiration is always performed to the VR, and without performing the active contraction of the abdominal muscles. Still prompted an inspiratory pause of 2 seconds for the end of the inspiratory phase. This procedure will be performed in 4 sets of 5 minutes with interval of 1 minute between the series.
16039448|NCT02600026|Device|DriveCam|Video event monitoring device
16039449|NCT02600026|Behavioral|Feedback|Video feedback intervention
16039450|NCT02600000|Radiation|Myocardial scintigraphy|Myocardial scintigraphy with Iodo123-Metaiodobenzylguanidine (MIBG) to assess the Sympathetic myocardial activity
16039451|NCT02600000|Device|Cardiopulmonary test|Assessment of maximal functional capacity
16039452|NCT02600000|Device|AVD-Glittre Test|Evaluation of submaximal functional capacity after inspiratory muscle training.
16039453|NCT02600000|Device|Diaphragm ultrasound|Evaluation of thickness and diaphragmatic mobility
16039454|NCT02599987|Device|POWERbreathe® Classic Light|Inspiratory Muscle Training
16039455|NCT02599961|Drug|UX007|UX007 is a liquid intended for oral (PO) administration.
16039456|NCT02599948|Other|no intervention|
16039457|NCT02599935|Dietary Supplement|Hypercaloric beverages|Nutritional supplement: Hypercaloric beverages
16039458|NCT02599935|Other|standard treatment|No other than standard treatment
16039459|NCT02599935|Other|educational structured counseling|Nutritional counseling leaded to patient and caregivers
16039460|NCT02599922|Biological|rAAV2tYF-PR1.7-hCNGB3|rAAV2tYF-PR1.7-hCNGB3 is a non-replicating, rep/cap-deleted, recombinant adeno-associated virus vector that expresses the CNGB3 gene.
16039461|NCT02599896|Biological|VRC-HIVMAB080-00-AB (VRC01LS)|VRC01LS is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.
16039462|NCT02599896|Biological|VRC-HIVMAB060-00-AB (VRC01)|VRC01 is an Investigational Monoclonal Antibody targeted to the CD4 binding site of HIV-1.
16039463|NCT02599883|Radiation|Low-Dose Computed Tomography|Low-Dose Computed Tomography will be administered to COPD patients as part of COPD phenotypization.
16039464|NCT02599870|Genetic|NeuroIDgenetix Test Panel|The NeuroIDgenetix Test Panel is used to make recommendations on post-operative pain medication therapy that may be impacted by the genetic background of the patient.
16039465|NCT02599857|Device|CONCOR smartphone application|
16039466|NCT02599844|Drug|Iodohippurate|An injection of non-radioactive iodohippurate (0.07 mL/kg) will be administered to determine renal plasma flow (RPF)
16039467|NCT02599844|Procedure|24 hour ambulatory Blood Pressure|Ambulatory blood pressure (BP) monitoring will be performed using a commercially available device (TIBA Ambulo 2400) for 24 hours with measurements every 30 minutes while awake and every hour during sleep.
16039468|NCT02599844|Procedure|Peripheral Arterial Tonometry|The peripheral arterial tonometry (PAT) device measures changes in the cutaneous circulation that correlate with flow-mediated dilatation.
16039469|NCT02599844|Procedure|Pulse Wave Velocity|Carotid-femoral and carotid-radial pulse wave velocities (PWV), validated markers of individual cardiovascular risk, will be determined by applanation tonometry using SphygmoCorVx technology (AtCor Medical). PWV is an index of the overall stiffness of a vascular segment between measurement sites 59. Thus, while carotid-femoral PWV is an index of the overall stiffness of proximal (central) arteries, the overall stiffness of peripheral arteries contributes relatively more to carotid-radial PWV.
16039470|NCT02599844|Drug|Gadolinium|Magnevist Gadolinium (GD)-diethylene-triamine-pentaacetic acid-bis-oleate (0.07 to 0.14 mL/kg) will be used to determine GFR.
16039555|NCT02599233|Other|Telephone conctact at 3 months|Patients will be contacted at 3 months post-surgery for pain questionnaires.
16039471|NCT02599831|Device|Electrical pudendal nerve stimulation|Four sacrococcygeal points are selected. The two upper points are located about 1 cm bilateral to the sacrococcygeal joint. On the upper points, a needle of 0.40 Х 100 mm is inserted perpendicularly to a depth of 80 to 90 mm to produce a sensation referred to the root of the penis (perineum) or the anus. The locations of the two lower points are about 1 cm bilateral to the tip of the coccyx. On the lower points, a needle of 0.40 Х 100 or 125 mm is inserted obliquely towards the ischiorectal fossa to a depth of 90 to 110 mm to produce a sensation referred to the root of the penis (perineum). After the sensation referred to the above regions is produced, each of two pairs of electrodes from a G6805-2 Multi-Purpose Health Device is connected with the two ipsilaterally inserted needles.
16039472|NCT02599831|Device|PFM training|A nerve function reconstruction treatment system (AM1000B; Shenzhen Creative Industry Co.Ltd, China) is used for EMG-biofeedback assisted PFMT.
16039473|NCT02599831|Device|Transanal ES|A neuromuscular stimulation therapy system (PHENIX USB 4，Electronic Concept Lignon Innovation, France) is used for TES
16039474|NCT02599818|Behavioral|NavSTAR|Participants in the NavSTAR program will work with a team of case workers who will provide motivational intervention and proactive barrier resolution services using patient navigation
16039475|NCT02599805|Device|Natrox™ Oxygen Delivery System (ODS)|Natrox™ ODS will be applied to the subject's diabetic ulcer and attached to the active Natrox™ Oxygen Generator using the tubing provided or regular dressing will be used. The Natrox™ oxygen delivery system (ODS) is a device designed to overcome a number of problems associated with previous methods of oxygen therapy by delivering continuous oxygen to the ulcer bed through a dressing.
16039476|NCT02599792|Drug|CTP-656|
16039477|NCT02599792|Drug|Placebo for CTP-656|
16039478|NCT02599792|Drug|Kalydeco|
16039479|NCT02599779|Drug|Pembrolizumab|200mg given intravenously over 30 minutes day 1 of every 3 week cycle until progression as per immune related response criteria
16039480|NCT02599779|Radiation|Stereotactic Body Radiation Therapy|Dose and duration dependent on body site. In Arm A: SBRT given at the time of progression on pembrolizumab. In Arm B: SBRT given before the 2nd course of pembrolizumab.
16039481|NCT02599766|Other|animal assisted therapy|physiotherapy, speech therapy and occupational therapy in the presence of an animal
16039482|NCT02599766|Other|standard therapy|standard physiotherapy, standard speech therapy and standard occupational therapy
16039483|NCT02599753|Drug|18-FDTBZ|"During this study, participants will receive a single i.v. administration of approximately 370MBq (10 mCi) 18F- DTBZ immediately prior to imaging. The dosage of DTBZ is 10 nmole. The effective dose in human body is about 5.6 mSV.
~The proposed dose for this study is based on the investigators' phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG (Lin 2010)."
16039484|NCT02599740|Other|Natural fruit extract|Natural fruit extract consumed with rice
16039485|NCT02599740|Other|Assumed active|Assumed key active consumed with rice
16039486|NCT02599740|Other|Placebo|Rice only
16039487|NCT02599727|Other|Isometric exercises|subjects will perform specific isometric exercises for 10-20 minutes, three times a week throughout the enrollment period
16039488|NCT02599727|Other|No exercise|Subjects will go on with their life without any specific isometric exercise regimen during the enrollment period
16039489|NCT02599714|Drug|AZD2014|The triplet combination will be comprised of AZD2014 + palbociclib + fulvestrant.
16039490|NCT02599714|Drug|Palbociclib|cyclin dependent kinase inhibitor
16039491|NCT02599714|Drug|Fulvestrant|Fulvestrant hormonal therapy as background
16039492|NCT02599701|Drug|Gabapentin|A single dose Gabapentin 300mg at bedtime.
16039493|NCT02599701|Drug|Placebo|A single placebo dose with the same physical characteristics of the active intervention.
16039494|NCT02599688|Other|Observation only|No intervention in this study.
16039495|NCT02599675|Dietary Supplement|Vitamin D3|Vitamin D3 dissolved in olive oil, encapsuled
16039496|NCT02599675|Dietary Supplement|Placebo|Olive oil, encapsuled
16039497|NCT02599662|Radiation|10 Gy Low-KV IORT|: intraoperative low-kV IORT will be delivered as a single dose of 10 Gy at 2 millimeter depth. Doses will be escalated in increments of 5 Gy until completion of 20 Gy dose level or the DLT is reached and MTD is realized.
16039498|NCT02599662|Radiation|15 Gy Low-KV IORT|intraoperative low-kV IORT will be delivered as a single dose of 15 Gy at 2 millimeter depth. Doses will be escalated in increments of 5 Gy until completion of 20 Gy dose level or the DLT is reached and MTD is realized.
16039499|NCT02599662|Radiation|20 GY Low-KV IORT|intraoperative low-kV IORT will be delivered as a single dose of 20 Gy at 2 millimeter depth. Patients will be accrued to this group until the DLT is reached and MTD is realized.
16039500|NCT02599649|Drug|Lirilumab|3 mg/kg by vein every 4 weeks.
16039501|NCT02599649|Drug|Nivolumab|3 mg/kg by vein on Days 7 and 21 of a 28 day cycle.
16039502|NCT02599649|Drug|Azacitidine|75 mg/m^2 by vein for 7 days of a 28 day cycle.
16039503|NCT02599636|Other|None intervention|Investigators will study the usual medical assistance
16039504|NCT02599623|Procedure|Local Anesthesia|Patients in LA group received the local infiltration technique. A mixture of 2% lidocaine 20ml and 0.9%NS 30ml was used as the local anesthetic. Patients required extra analgesia during the surgery were given 20-40mg parecoxib sodium intravenously. Conversion to GA was performed if LA was intolerant for patient, which was evaluated by both anesthetists and surgeons.
16039505|NCT02599623|Procedure|General Anesthesia|In group GA, anesthesia was induced with propofol 2mg/kg and fentanyl 0.1-0.2mg intravenously. Inhalation anesthesia was given at the same time with a mixture of oxygen and isoflurane 1-2% through an intubation.
16039506|NCT02599610|Other|Digital vaginal examination|Patients will be subject to digital vaginal examinations every four hours during latent phase of first stage, hourly during active phase of first stage and as needed during second stage.
16039507|NCT02599610|Device|Transperineal ultrasound examination|Patients will be subject to transperineal ultrasound examinations every four hours during latent phase of first stage, hourly during active phase of first stage and as needed during second stage.
16039508|NCT02599597|Behavioral|Therapist-assisted iCBT|13 week long individualized prevention program containing, physical activation, sleep management, tailored cognitive behavioral therapy for individual problems.
16039509|NCT02599597|Behavioral|Monthly screening with feedback|Participants are screened with a depression inventory each month and receives feedback from a therapist on the results
16039510|NCT02599584|Behavioral|precritical staff|free pre critical scenario team staff
16039511|NCT02599571|Other|Very low nicotine content cigarettes|Cigarettes containing a reduced amount of nicotine
16039512|NCT02599571|Other|Conventional nicotine content cigarettes|Cigarettes containing a normal amount of nicotine
16039513|NCT02599558|Device|Cytosponge|Patients undergoing the six food elimination diet will be monitored through the diet with swallowing the cytosponge. This is a ten minute procedure in the office. The cytosponge will be sent to the lab for histology reading of the eosinophilic count.
16039514|NCT02599558|Other|Diet|Investigators will reintroduce 1 of the six food for two weeks, then another for two weeks. Participant will return for the cytosponge procedure which will help the Investigator to direct which foods will be add or removed for the next two to four weeks. This will be repeated until all six foods have been reintroduced back into the participants diet.
16039515|NCT02599558|Other|Phone call|The study coordinator will call the participant two weeks after the participate has added in one of the six foods as directed by the Investigator, completing a short questionnaire (esophageal eosinophilic Activity Index Pro) EEsAI Pro.
16039516|NCT02599558|Other|EEsAI Pro|This is a short questionnaire to assess the participants swallowing. This will be completed at baseline, two weeks after a food has been added to the diet and at the final visit.
16039517|NCT02599532|Drug|apixaban|Study subjects will be given a single-dose of apixaban 10 mg.
16039518|NCT02599493|Drug|Rifampicin|Patients will be randomly assigned to low dosage (10 mg/kg/j) rifampicin group or high dosage (20 mg/kg/j) rifampicin group. Rifampicin treatment will be prescribed in association with another antibiotic chosen by investigator according to the antibiogram results. Association with fluoroquinolones is the first choice combination, if it is possible. The global antibiotic treatment duration depends on the investigator's choice.
16039519|NCT02599480|Drug|mirabegron|50 mg daily during 12 months
16039520|NCT02599480|Procedure|Echocardiography|Echocardiography
16039521|NCT02599480|Procedure|Cardiac MRI|Cardiac MRI
16039522|NCT02599480|Procedure|Maximal exercise capacity|Maximal exercise capacity
16039523|NCT02599480|Procedure|Blood sampling|Blood sampling for study assessments and future exploratory studies.
16039524|NCT02599480|Procedure|Endothelial function measurement|EndoPAT assessment
16039525|NCT02599480|Radiation|18FDG-PET|PET scanning for beige/brown fat activation
16039526|NCT02599467|Other|ULNT 1 and EMG recording|While the ULNT 1 was performing, EMG muscle activity form biceps brachii and triceps brachii were recorded. The maneuver was stopped to measure abduction, external rotation and elbow flexion range of motion (ROM) with a goniometer. Three measurements were performed: measure 1) when the first sense of tightness perceived by the subject appeared; measure 2) when evoked muscle activity increased on EMG record; measure 3) when sense of final resistance perceived by the investigator appeared. Considering the increase of symptoms with contralateral or decrease of symptoms with ipsilateral cervical side bending as mandatory positivity criterion.
16039527|NCT02599454|Drug|Atezolizumab|Into the vein Day 1 every 3 weeks for 6 cycles
16039528|NCT02599454|Radiation|Stereotactic Body Radiation Therapy|Radiation therapy will be performed to 50 Gy over 4 fractions of 12/5 Gy each for peripherally located tumors and 50 Gy over 5 fractions of 10 Gy each for centrally located tumors
16039529|NCT02599415|Device|TL01 light treatment|Patients received treatment in TL01 cabinet three sessions weekly according to a standard escalating protocol based on minimal erythema dose. Standard dose ranges between 0.55 and 3.13J/cm2.
16039530|NCT02599402|Drug|Nivolumab|
16039531|NCT02599402|Drug|Ipilimumab|
16039532|NCT02599389|Device|Drug-coated balloons|
16039533|NCT02599389|Device|Excimer Laser|
16039534|NCT02599376|Device|LiDCOrapid|Cardiac output will be non invasively monitored by using 2 cuffs on fingers.
16039535|NCT02599363|Drug|Ribociclib (LEE011)|
16039536|NCT02599363|Drug|Paclitaxel|
16039537|NCT02599337|Drug|Nexavar|"Single oral dose (1 x 200 mg) sorafenib or Nexavar in each period. No food were allowed from at least 10 hours before dosing until at least 4 hours after dosing.
~Except for water given with study medication, no fluids were allowed from 1 hour before dosing until 1 hour post-dose."
16039538|NCT02599337|Drug|Sorafenib|"Single oral dose (1 x 200 mg) sorafenib or Nexavar in each period. No food were allowed from at least 10 hours before dosing until at least 4 hours after dosing.
~Except for water given with study medication, no fluids were allowed from 1 hour before dosing until 1 hour post-dose."
16039539|NCT02599324|Drug|Ibrutinib|
16039540|NCT02599324|Drug|Everolimus|
16039541|NCT02599324|Drug|Docetaxel|
16039542|NCT02599324|Drug|Paclitaxel|
16039543|NCT02599324|Drug|Cetuximab|
16039544|NCT02599324|Drug|Pembrolizumab|
16039545|NCT02599311|Device|transvaginal synthetic mesh|transvaginal synthetic mesh
16039546|NCT02599311|Drug|Tolterodine|Tolterodine tartrate can improve patients' LUTS.
16039547|NCT02599298|Device|Continuous Positive Airway Therapy|
16039548|NCT02599298|Behavioral|Sleep-Study Guided Multidisciplinary Therapy|
16039549|NCT02599285|Device|Fixation|Fixation of the posterior malleolus with lag-screws or plate-fixation. If syndesmosis is intra-operatively stable, no syndesmotic positioning screws will be placed.
16039550|NCT02599285|Device|NO Fixation|Posterior malleolus will not be fixated. Syndesmotic positioning screws will be placed.
16039551|NCT02599272|Other|Rice with tomatoes and peeled aubergine (no spice)|Dose 0
16039552|NCT02599272|Other|Rice with vegetables and low spice|Dose 1, Rice with mixed spices (turmeric, coriander, cumin, gooseberry cayenne pepper, cinnamon, clove), tomatoes, peeled aubergine, onion, ginger and garlic
16039553|NCT02599272|Other|Rice with vegetables and high spice|Dose 2, Rice with mixed spices (turmeric, coriander, cumin, gooseberry cayenne pepper, cinnamon, clove), tomatoes, onion, ginger and garlic
16039554|NCT02599259|Device|Monitored (M+)|Patients assigned to the intervention arm will use the AiCure Platform to monitor ingestion of all prescribed doses of oral anticoagulants. If a patient misses a dose, takes an incorrect dose, or their data are flagged for suspicious activity, they will be contacted by the Study Coordinator or AiCure study team.
16039733|NCT02598102|Drug|Placebo|Placebo for comparison
16039556|NCT02599233|Other|In hospital pain evaluation|Patients will evaluate their pain levels via a verbal numerical scale on days 1(or-1), 2, 3, 4, 5, 6 & 7.
16039557|NCT02599233|Other|In hospital questionnaires|Patients are required to fill out the HADS and PCS questionnaires between on day -1 or +1.
16039558|NCT02599207|Biological|sibling umbilical cord blood|All subjects will receive a single infusion of allogeneic sibling cord blood. The first six subjects will receive cord blood cells from an HLA-matched sibling. The following 9 subjects will receive cord blood cells from an HLA-mismatched (≥3/6 match) or matched sibling. Six of the 15 subjects must be treated with haplo-identical sibling CB. Duration of study participation will be six months from the time of CB infusion.
16039559|NCT02599194|Drug|18F-FSPG|Administered intravenously (IV)
16039560|NCT02599194|Drug|18F-FDG|Administered intravenously (IV)
16039561|NCT02599181|Other|propanol-biphenol: Kodan|WITH-group, the skin is disinfected with an aerosolized alcoholic solutionpropanol-biphenol: Kodan, Schülke & Mayr, Zurich, Switzerland.
16039562|NCT02599168|Drug|Propofol|
16039563|NCT02599168|Drug|Dexmedetomidine|
16039564|NCT02599168|Drug|Placebo (normal saline)|
16039565|NCT02599155|Drug|Crystalloid|normal saline administration for volume expansion in hypovolemic status
16039566|NCT02599155|Drug|Colloid|HES 130/0.4 administration for volume expansion in hypovolemic status
16039567|NCT02599142|Device|Group A: Closed-face shell|As for arm description
16039568|NCT02599142|Device|Group B: Open-face shell|As for arm description
16039569|NCT02599129|Drug|Secukinumab|subcutaneous secukinumab (300 mg) at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including Week 20.
16039570|NCT02599129|Drug|Placebo|￼subcutaneous placebo at weeks 0, 1, 2, 3, 4 and every 4 weeks thereafter up to and including week 20.
16039571|NCT02599116|Other|Bio-specimen collection|Collection of bio-specimens (fecal sample) at 3 different time points One pre-operative collection, Two post-operative collections
16039572|NCT02599116|Other|Questionnaire|Completion of lifestyle and food questionnaires (2) at each bio-specimen collection timepoint
16039573|NCT02599103|Other|Fat-free milkshake|participants drinks a fat-free milk shakes
16039574|NCT02599103|Other|Olive oil|participants drinks the milk shakes prepared from 60g of olive oil
16039575|NCT02599103|Other|Soybean oil|participants drinks the milk shakes prepared from 60g of soybean oil
16039576|NCT02599103|Other|Fried soybean oil|participants drinks the milk shakes prepared from 60g of fried soybean oil
16039577|NCT02599103|Other|Palm oil|participants drinks the milk shakes prepared from 60g of palm oil
16039578|NCT02599103|Other|Fried palm oil|participants drinks the milk shakes prepared from 60g of fried palm oil
16039579|NCT02599103|Other|Camellia oil|participants drinks the milk shakes prepared from 60g of camellia oil
16039580|NCT02599103|Other|Fried camellia oil|participants drinks the milk shakes prepared from 60g of fried camellia oil
16039581|NCT02599103|Other|Tallow|participants drinks the milk shakes prepared from 60g of tallow
16039582|NCT02599103|Other|Fried tallow|participants drinks the milk shakes prepared from 60g of fried tallow
16039583|NCT02599090|Drug|Temozolomide|"Groups 1 & 2: 75 mg/m^2 Once Daily by Mouth During Radiation; 4 Weeks after Completion of Radiation, 150-200 mg/m^2 Once Daily by Mouth Days 1-5 of 1st 28-Day Cycle, then 75 mg/m^2 Once Daily by Mouth Days 1-5 for Subsequent 28-Day Cycles.
~Groups 3 & 4: 75 mg/m^2 Once Daily by Mouth During Radiation; 4 Weeks after Completion of Radiation, 75-100 mg/m^2 Once Daily by Mouth Days 1-21 every 28-Day Cycle."
16039584|NCT02599090|Radiation|Radiation|Total of 60 Gy delivered over 30 Days (approximately 6 weeks).
16039585|NCT02599090|Drug|Sorafenib|"Group 1: 4 Weeks after Completion of Radiation, 400 mg Twice Daily by Mouth.
~Group 2: 200 mg Twice Daily by Mouth during Radiation; 4 Weeks after Completion of Radiation, 400 mg Twice Daily by Mouth.
~Group 3: 200 mg Twice Daily by Mouth during Radiation; 4 Weeks after Completion of Radiation, 200 mg Twice Daily by Mouth.
~Group 4: 400 mg Twice Daily by Mouth during Radiation; 4 Weeks after Completion of Radiation, 400 mg Twice Daily by Mouth."
16039586|NCT02599077|Drug|Dienogest|patients assigned to this treatment receive 2 milligrams per day
16039587|NCT02599077|Drug|Levonorgestrel|patients assigned to this treatment receive (0.10 mg levonorgestrel + ethinyl estradiol - 0.02 milligrams daily)
16039588|NCT02599064|Drug|RXI-109|RXI-109 dosed intravitreally to subjects with NVAMD
16039589|NCT02599051|Device|Mini-arc|We will place a single incision sling at the time of surgery for stress urinary incontinence
16039590|NCT02599051|Device|Monarc|We will place a transobturator sling at the time of surgery for stress urinary incontinence
16039591|NCT02599038|Dietary Supplement|Serine supplementation|Serine supplementation (200 mg/kg/day)
16039592|NCT02599025|Device|Innowalk cycling system|Innowalk is a unique, motorized medical device
16039593|NCT02599025|Device|APT cycling system|APT is used as a rehabilitative device that cycles the feet automatically or by the individual
16039594|NCT02599012|Drug|Ferinject®|intravenous Ferinject 1000mg injection
16039595|NCT02598999|Drug|ALX-009|Solution for inhalation administered through nebulization
16039596|NCT02598999|Drug|OSCN-|Solution for inhalation administered through nebulization
16039597|NCT02598999|Drug|bLF|Solution for inhalation administered through nebulization
16039598|NCT02598999|Drug|Placebo|Solution for inhalation administered through nebulization, Sodium Chloride 0.9%
16039599|NCT02598986|Dietary Supplement|Macronutrient supplementation|adding of phosphorus, potassium and magnesium
16039600|NCT02598973|Behavioral|Exercise|Aerobic walking
16039601|NCT02598960|Drug|BMS-986156|
16039602|NCT02598960|Drug|Nivolumab|
16039603|NCT02598947|Other|Manual therapy|Exercise and manual therapy
16039604|NCT02598934|Drug|Ibandronate|Participants will receive oral ibandronate, 150 mg once weekly, for approximately 6 months.
16039605|NCT02598921|Radiation|three dimensional ultrasound|
16039606|NCT02598921|Device|Office hysteroscopy|
16039607|NCT02598908|Diagnostic Test|Quality control - enzyme activity|A blood sample will be collected from patients and staff donors, no more than twice per year.
16039608|NCT02598895|Drug|Carboplatin|Given IV
16039609|NCT02598895|Drug|Docetaxel|Given IV
16039610|NCT02598895|Other|Laboratory Biomarker Analysis|Correlative studies
16039611|NCT02598882|Device|videogame|Patients will be an assessment of quadriceps muscle strength by surface electromyography, before and after a 30-minute guided activity through an active video game
16039612|NCT02598882|Device|treadmill|Patients will be an assessment of quadriceps muscle strength by surface electromyography, before and after a 30-minute activity in treadmill.
16039613|NCT02598869|Drug|Triamcinolone Acetonide|injection of triamcinolone acetonide
16039614|NCT02598856|Drug|Intranasal (IN) naloxone 1x|Administered as 100 μl 14.0 mg/ml (1.4 mg naloxone) by Aptar Unitdose device as one puff in one nostril
16039615|NCT02598856|Drug|Intranasal (IN) naloxone 2|Administered as 2x 100 μl 14 mg/ml (2.8 mg naloxone) by Aptar Unitdose device as two puffs within the same nostril with 3 minutes interval
16039616|NCT02598856|Drug|Intravenous (IV) naloxone|Administered as 1 ml Naloxon B Braun 0.4 mg/ml (0.4 mg naloxone), in an intravenous cannula in the opposite arm of which the blood samples are drawn from. IV bolus will be given rapidly (in less than 5 seconds)
16039617|NCT02598856|Drug|Intramuscular (IM) naloxone|Naloxone administered as 2 ml Naloxon B Braun 0.4 mg/ml (0.8 mg naloxone) in a Braun Omnifix 2.5 ml syringe using a BD Microlance 3 21G (green) 0.8x40 mm needle in the deltoid muscle of the non-dominant arm
16039618|NCT02598843|Other|Standard treatment protocol|"Cast Protocol 4 weeks in Full Equinus cast - Non Weight Bearing (NWB) with axillary crutches; 4 weeks in Semi-Equinus cast NWB with axillary crutches; 2 weeks in neutral cast - Full Weight Bearing (FWB); 2 weeks FWB out of cast, with shoe insert heel raise.
~Followed by course of physiotherapy"
16039619|NCT02598843|Other|Accelerated Rehabilitation|"4 weeks in Ossur Rebound walking boot with 3cm heel raise, worn continuously including in bed. Weight bearing as tolerated (WBAT)/FWB - crutches for balance; 2 weeks in Rebound walking boot with 1.5cm heel raise (WBAT/FWB - crutches for balance; 2 weeks in Rebound walking boot with foot in neutral. At 8 weeks, remove boot and allow FWB out of boot.
~At 8 weeks after initiation of treatment, physiotherapy is commenced."
16039620|NCT02598830|Dietary Supplement|Vitamin D3|Vitamin D3 dissolved in olive oil, encapsuled
16039621|NCT02598830|Dietary Supplement|Placebo|Olive oil, encapsuled
16039622|NCT02598817|Other|Standard Infant Formula|Standard Infant Formula containing High Sn-2
16039623|NCT02598804|Other|5 educational workshop|
16039624|NCT02598804|Other|written information booklet|
16039625|NCT02598791|Other|IIGI+GIP|Glucose-dependent insulinotropic polypeptide (4 pmol/kg/min) during isoglycemia
16039626|NCT02598791|Other|IIGI+GLP-1|glucagon-like peptide-1 (1 pmol/kg/min) during isoglycemia
16039627|NCT02598791|Other|IIGI+NaCl (placebo)|i.v. NaCl during isoglycemia
16039628|NCT02598791|Other|OGTT|50 g oral glucose tolerance test
16039629|NCT02598791|Other|IIGI+GIP+GLP-1|i.v infusion of GIP and GLP-1 (4 + 1 pmol/kg/min) during isoglycemia
16039630|NCT02598778|Drug|Chlorhexidine gluconate (.12%)|30 second oral rinse of 10mL of solution
16039631|NCT02598778|Drug|Sodium Fluoride (.05%)|30 second oral rinse of 10mL of solution
16039632|NCT02598778|Other|Coconut Oil|30 second oral rinse of 10mL of solution
16039633|NCT02598778|Other|Deionized water|30 second oral rinse of 10mL of solution
16039634|NCT02598765|Procedure|Standard Trabeculectomy|Fornix-based trabeculectomy with a 3x4 mm scleral flap.
16039635|NCT02598765|Procedure|Microtrabeculectomy|Fornix-based trabeculectomy with a 2x2 mm scleral flap.
16039636|NCT02598752|Other|Symptom-limited cardiopulmonary exercise test (CPET)|
16039637|NCT02598752|Other|Resting assessment of cardiac function by echocardiography|
16039638|NCT02598752|Other|Post-exercise assessment of cardiac function by echocardiography|
16039639|NCT02598752|Other|Pulmonary function|
16039640|NCT02598752|Behavioral|Patient-reported outcomes questionnaire|
16039641|NCT02598739|Other|Resistance exercise|"Underwent resistance exercise twice a week, for twelve weeks. The IG patients performed resistance exercises for the following muscles group: upper limbs, lower limbs and trunk.
~It was carried out two exercises for major muscle groups and one exercise for small muscles. The exercises were divided in 3 sets of 12 repetitions for each muscle group. The intensity of the exercises were 60% of one-maximum repetition (1RM).
~The exercise program involved pectoral exercises: crucifix and seat supine; biceps: alternated screw; triceps: triceps pulley; back: standing handsaw and pulled ahead; quadriceps: leg extensor and finally gluteo: standing hips extension."
16039642|NCT02598739|Other|Waiting list for the exercises|
16039643|NCT02598726|Drug|Curcumin|Given PO
16039644|NCT02598726|Other|Laboratory Biomarker Analysis|Correlative studies
16039645|NCT02598726|Dietary Supplement|Piperine Extract (Standardized)|Given PO
16039646|NCT02598726|Other|Quality-of-Life Assessment|Ancillary studies
16039647|NCT02598713|Drug|Aspiration Marker|Instillation of Quinine suspended in sterile water in the retropharyngeal space of intubated ICU admitted patients for two consecutive days.
16039648|NCT02598687|Drug|TH-302|TH-302 day 4 (pre-treatment) and weekly during chemo-radiotherapy (CRT)
16039649|NCT02598687|Other|HX4 scan|HX 4 scan day 1 and day 8
16039650|NCT02598687|Drug|Carboplatin|2mg/ml/min
16039651|NCT02598687|Drug|Paclitaxel|50 mg/m2
16039652|NCT02598687|Radiation|Radiotherapy|23 x 1.8 Gy
16039653|NCT02598687|Procedure|surgery|minimally invasive transhiatal approach including a one-field node dissection or transthoracic approach with a two-field lymph node dissection
16039654|NCT02598674|Drug|Iodohippurate|An injection of non-radioactive iodohippurate (0.07 mL/kg) will be administered to determine renal plasma flow (RPF)
16039655|NCT02598674|Procedure|24 hour ambulatory Blood Pressure|Ambulatory blood pressure (BP) monitoring will be performed using a commercially available device (TIBA Ambulo 2400) for 24 hours with measurements every 30 minutes while awake and every hour during sleep.
16039656|NCT02598674|Procedure|Peripheral Arterial Tonometry|The peripheral arterial tonometry (PAT) device measures changes in the cutaneous circulation that correlate with flow-mediated dilatation.
16039657|NCT02598674|Procedure|Pulse Wave Velocity|Carotid-femoral and carotid-radial pulse wave velocities (PWV), validated markers of individual cardiovascular risk, will be determined by applanation tonometry using SphygmoCorVx technology (AtCor Medical). PWV is an index of the overall stiffness of a vascular segment between measurement sites 59. Thus, while carotid-femoral PWV is an index of the overall stiffness of proximal (central) arteries, the overall stiffness of peripheral arteries contributes relatively more to carotid-radial PWV.
16039658|NCT02598674|Drug|Gadolinium|Dotarem Gadolinium (GD)- Gadoterate Meglumine (0.07 to 0.14 mL/kg) will be used to determine GFR.
16039659|NCT02598661|Drug|Imetelstat|Imetelstat will be administered at a starting dose of 7.5 milligram per kilogram (mg/kg) given intravenously every 4 weeks, until disease progression, unacceptable toxicity, or withdrawal of consent, or lack of response.
16039660|NCT02598661|Drug|Placebo|Matching Placebo to Imetelstat will be administered.
16039661|NCT02598648|Other|FXR|FXR could elevate the transcription of RIPK3, a key protein in necroptosis, and play important role in bile aicd induced alveolar epithelial cell(AEC) necroptosis. FXR were measured in neonate with ALI、ARDS and control
16039662|NCT02598648|Other|RIPK3|FXR(farnesoid-X-receptor) could elevate the transcription of RIPK3, a key protein in necroptosis, and play important role in bile aicd induced alveolar epithelial cell(AEC) necroptosis. RIPK3 were measured in neonate with ALI、ARDS and control.
16039663|NCT02598635|Drug|Cholecalciferol|Patients on peritoneal dialysis and 25-(OH) levels <20 ng/mL will received one capsule of cholecalciferol (4800 U) once a day for 16 weeks.
16039664|NCT02598635|Drug|Placebo|An oral placebo capsule matching Cholecalciferol in terms of appearance, smell and taste will be administered once a day for 16 weeks.
16039665|NCT02598622|Drug|Acetylcarnitine|Acetylcarnitine is taken 2 times a day for days 1 through 21.
16039666|NCT02598622|Drug|Placebo|Placebo is taken 2 times a day for days 1 through 21.
16039667|NCT02598609|Behavioral|Education program for NICU caregivers|"standardized educational program : learning how to retrospectively analyze causes of a medical error in the NICU in order to prevent it (compulsory)
~implementation of a central line maintenance bundle and checklist, of a central line insertion bundle and checklist and of a daily goals bundle and checklist. (compulsory)
~poster for prevention of extravasation injuries"
16039668|NCT02598596|Biological|Pegloticase|Pegloticase, IV
16039669|NCT02598596|Drug|Azathioprine|Azathioprine (1.25 mg/kg, followed by 2.5 mg/kg) oral, daily
16039670|NCT02598583|Biological|ALXN1210|
16039671|NCT02598570|Drug|duvelisib|Duvelisib will be administered orally as a fixed dose in 28-day cycles.
16039672|NCT02598557|Drug|Exemestane|Given PO
16039673|NCT02598557|Other|Laboratory Biomarker Analysis|Correlative studies
16039674|NCT02598557|Other|Pharmacological Study|Correlative studies
16039675|NCT02598557|Other|Placebo Administration|Given PO
16039676|NCT02598557|Other|Quality-of-Life Assessment|Ancillary studies
16039677|NCT02598557|Other|Questionnaire Administration|Ancillary studies
16039678|NCT02598557|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16039679|NCT02598544|Other|adipose tissue sampling|adipose tissue (subcutaneous and visceral adipose tissue) sampling during abdominal surgery and phenotype determination
16039680|NCT02598518|Behavioral|Integrating Combined Therapies|Individual Integrating Combined Therapies, approximately 10 sessions, one session per week
16039681|NCT02598518|Behavioral|Standard Care|Standard Care, individual or group therapy, approximately 9 hours per week for 3 months.
16039682|NCT02598505|Drug|Indacaterol|
16039683|NCT02598505|Drug|Placebo|
16039684|NCT02598492|Other|arterial blood gas|Just record clinical lab data
16039685|NCT02598479|Other|IPTLD and nutrition therapy|The measurement of Quality of Life in patients who choose to use Insulin Potentiation Low Dose Therapy and Nutritional Therapy in the treatment of cancer
16039686|NCT02598466|Drug|Abatacept|
16039687|NCT02598453|Drug|Ibandronate|Either 150 mg oral tablet once monthly or 3 mg IV injection once every 3 months
16039688|NCT02598440|Drug|Alendronate|Participants wil receive once-weekly oral alendronate (70 mg tablet)
16039689|NCT02598440|Drug|Ibandronate|Participants wil receive once-monthly oral ibandronate (150 mg tablet)
16039690|NCT02598427|Drug|Pertuzumab|Pertuzumab will be administered intrathecally via a lumber puncture. The dosing cohorts are described above in the arm description.
16039691|NCT02598427|Drug|Trastuzumab|Trastuzumab will be administered intrathecally via a lumber puncture. The dosing cohorts are described above in the arm description.
16039692|NCT02598414|Procedure|Near-infrared ICG fluorescence imaging|Patient will have their bowel anastomosis assessed intraoperatively by near-infrared technology after indocyanine green has been injected intravenously at a concentration of 2.5 mg/ml. This procedure will be repeated twice during surgery, the first time before and the second time after the anastomosis has been done. The microvascularization at the anastomosis site will be assessed using a robotic fluorescence imaging device (FireFly™).
16039693|NCT02598414|Procedure|Traditional bowel anastomosis|Traditional bowel anastomosis will be performed without ICG fluorescence imaging.
16039694|NCT02598414|Device|FireFly™|The microvascularization at the anastomosis site will be assessed using a robotic fluorescence imaging device (FireFly™).
16039695|NCT02598401|Other|observation|Observational study with no intervention
16039696|NCT02598388|Biological|Ad26.ZEBOV|One 0.5 mL intramuscular (IM) injection of (5x10*10 viral particles).
16039697|NCT02598388|Biological|MVA-BN-Filo|One 0.5 mL IM injection of (1x10*8 infectious units).
16039698|NCT02598388|Biological|Placebo|One 0.5 mL IM injection of 0.9 percent (%) saline.
16039699|NCT02598375|Other|Feeding intolerance|In this study ; it is aimed to show the value of IFABP regarding the identifying the feeding intolerance and early detection of enteral feeding intolerance
16039700|NCT02598362|Drug|ciprofloxacin|Serum and urine concentrations after ciprofloxacin administration. pharmacokinetic testing after ciprofloxacin administration
16039701|NCT02598349|Radiation|Proton Radiation|Proton Radiation 40.50 Gy relative biological effectiveness (RBE) in 18 fractions to gross disease and elective nodal volume followed by a 22.50 Gy (RBE) in 10 fraction boost to gross disease. Total dose 63 Gy (RBE) in 28 fractions over 6 weeks.
16039702|NCT02598349|Drug|Capecitabine|Concomitant oral chemotherapy, capecitabine 1000mg by mouth twice daily, 5 days a week (M-F) on radiation days only.
16039703|NCT02598349|Procedure|Surgical resection|Surgery between 8 and 16 weeks of radiotherapy completion if radiographic studies suggest operability.
16039704|NCT02598349|Behavioral|FACT-Hep questionnaire|The FACT-Hep questionnaire is specific to those with gastrointestinal cancers focusing on hepatobiliary and pancreatic cancer.
16039705|NCT02598336|Device|Structured Light Plethysmography|Non contact device that uses light to record displacement of the anterior thorax and abdomen region
16039706|NCT02598336|Device|Pneumotachograph Spirometry|Device that measures airflow at the mouth using a mouthpiece
16039707|NCT02598323|Device|ultrasound|
16039708|NCT02598310|Drug|nab-paclitaxel|nab-paclitaxel 260mg/m2 q3w
16039709|NCT02598310|Drug|Trastuzumab|trastuzumab 6 mg/kg (8 mg/kg as the loading dose)
16039710|NCT02598297|Drug|Ruxolitinib|5 mg tablet for oral use
16039711|NCT02598297|Drug|Ruxolitinib Placebo|5 mg placebo tablet for oral use
16039712|NCT02598284|Other|Point of Care|Practice facilitators will work with practices to implement strategies to improve ABCS care during the patient encounter. Some examples of these types of quality improvement initiatives are electronic reminders and clinical decision support to prescribe aspirin or a statin at the time of a visit, improving how your practice collects blood pressure measures to increase clinicians' willingness to act on readings, or electronic reminders for nursing staff that there is no lipid panel in record and have a standing order to act on this.
16039713|NCT02598284|Other|Population Management|"Practice Facilitators will work with practices to both implement Point of Care strategies as well as population management strategies. These practices will use their EHR and/or receive training to use the popHealth software package, which works with data from the EHR, to generate lists of high-risk patients that need outreach for one of the ABCS domains (such as conducting outreach to patients who are not on aspirin who would benefit from this therapy).
~Practices in this arm will receive the opportunity to link to community resources such as pharmacists who could assist patients with medication management or tobacco quit lines through the HealtheRx program."
16039714|NCT02598258|Other|Sauna and cold water bath|Subjects will first spend 10 minutes in a dry sauna at 85 degrees celtius. Immediately after, subjects will be immersed in a cold water bath (ICool , Australia) at a temperature of 5 degrees celtius for approximately one minute. Blood pressure , ecg , gaz exchange and thoracic impedance will be measured during sauna and cold water bath.
16039715|NCT02598245|Device|TOT 8/4|placement of transobturator sling according to the TOT 8/4 technique
16039716|NCT02598245|Device|TOT 6/3|placement of transobturator sling according to the TOT 6/3 technique
16039717|NCT02598232|Device|1,414nm Nd:YAG Laser System|It has high absorption coefficient in water and a short pulse width.
16039718|NCT02598219|Drug|Pre-operative SN mapping with radionucleide|"Preparation : four 1ml syringe (Nanocis, or Nanocoll, or Rotop-nanoHSA) are prepared per patient, each containing a total activity 10 MBq if the injection is planned the same day of surgery and in the operative theater OR each containing a total activity 30MBq if the injection is performed the day before the surgery.
~Intracervical injection is performed by the surgeon, no more than 3-24 hours before surgery : 4 submucous injections with the filtered radiocolloid at 3, 6, 9 and 12 o'clock positions. Each injection if performed at 2 mm of depth for a total activity of 40 MBq or a total activity of 120 MBq is the surgery is planned the day after the injection.
~Sentinel Node detection by planar scintigraphy at 1 and 3h (if no detection at 1 hour), or by SPECT-CT imaging if available."
16039719|NCT02598219|Drug|Intra-operative SN mapping with patent V blue dye|"Patent blue V dye are diluted with saline sterile solution to obtain 4ml of 50%. Four 1ml syringe, each containing a 50% patent blue dye solution, are prepared per patient.
~Intracervical injection is performed by the surgeon. after anesthesis induction and incising the skin,under laparoscopic / laparotomy control to detect intraperitoneal injection of the tracer. Sub-mucous injections are performed with 50% diluted dye at 3 and 9 o'clock positions. At each positions : 1ml is injected deep into the stroma of the cervix (1cm), another 1ml is injected superficially (at 2mm depth). The time between the injection of the dye and the search for the SN must be as shortest as possible.
~SN are detected by direct visualization of blue colored lymphatics and node"
16039720|NCT02598219|Drug|Intra-operative SN mapping with indocyanin green|"1: Infracyanine powder is diluted in aqueous sterile water to obtain 4ml with a concentration of 1.25 mg/mL. Four 1ml syringe, each containing a 1.25 mg/mL Infracyanine dye solution, are prepared per patient.
~2- Intracervical injection is performed by the surgeon, after anesthesis induction and incising the skin,under laparoscopic / laparotomy control to detect intraperitoneal injection of the tracer. Sub-mucous injections are performed with 50% diluted dye at 3 and 9 o'clock positions. At each positions : 1ml is injected deep into the stroma of the cervix (1cm), another 1ml is injected superficially (at 2mm depth). The time between the injection of the dye and the search for the SN must be as shortest as possible
~3- SN detection by near-infrared fluorescence imaging"
16039721|NCT02598219|Procedure|Full bilateral laparoscopic lymphadenectomy and Hysterectomy|"Bilateral pelvic lymphadenectomy (intermediate risk endometrioid)
~Or Ilio-infrarenal paraaortic lymphadenectomy (high risk endometrioid)
~Or Pelvic + paraaortic lymphadenectomies (high risk non endometrioid)"
16039722|NCT02598219|Procedure|Current initial staging protocols|Current French initial staging protocols
16039723|NCT02598206|Drug|PF-04136309|"Treatment A (n=18): a single dose of 1000 mg PF 04136309 will be administered in a fasted state as 8 × 125 mg Tablets.
~Treatment B (n=18): a single dose of 1000 mg PF-04136309 will be administered with a high fat breakfast as 8 × 125 mg Tablets."
16039724|NCT02598193|Drug|Nintedanib|Participants with IPF will receive nintedanib at the 200-300 mg/day dose up to 24 weeks.
16039725|NCT02598193|Drug|Pirfenidone|Participants with IPF will receive pirfenidone at 1602-2403 mg/day dose up to 24 weeks.
16039726|NCT02598180|Device|VergenixTM Flowable Gel|The VergenixTM Flowable Gel is supplied as powder contained in a syringe that will be hydrated with saline.
16039727|NCT02598141|Biological|Biological sampling grinding|One half of the biological material collected during the intervetion (according to standard procedures) will be ground using the Ultra Turrax technique before proceeding with culturing.
16039728|NCT02598141|Biological|Biological sampling with standard procedures|One half of the biological material collected during the intervetion (according to standard procedures) will be treated according to standard techniques before proceeding with culturing.
16039729|NCT02598128|Device|RELiZORB|Peptamen 1.5 received Period A and Period B (washout only). Impact Peptide 1.5 received Period B (Days 1 and 9 only) and Period C.
16039730|NCT02598128|Device|Placebo|Sham device
16039731|NCT02598115|Other|Collaborative Pharmaceutical Care|The pharmacist performs collaborative pharmaceutical care in the ward: reconciliation of drug treatments and revision of drug prescriptions indicated on the admission drug prescription. He/she emits pharmaceutical interventions recorded on the standardized support provided by the French Society of Clinical Pharmacy. The pharmaceutical interventions are discussed during a collaborative interview.
16039732|NCT02598102|Drug|Diclofenac sodium|Diclofenac for pain relief
16039736|NCT02598076|Behavioral|motivational interviewing|Motivational interviews will include the classical 4 steps of MI: 1) engagement (in which the patient's goals and interests are elicited and the therapeutic alliance is established); 2) focusing (in which the specific subjects of discussion and intervention are negotiated); 3) strengthening motivation (in which the patients' reasons for healthcare intervention are made explicit, discussed, and reinforced); and 4) planning (in which actions for healthcare intervention are planned out based on the patients' own goals and interests). MI will be performed by the study author who is a board certified neurologist and who has formal training and certification in motivational interviewing.
16039737|NCT02598076|Behavioral|standard psychotherapy|Standard cognitive behavioral therapy based psychotherapy for the treatment of PNES
16039738|NCT02598063|Drug|Adefovir dipivoxil|ADV will be administered orally at a dose of 10 mg QD for 72 weeks.
16039739|NCT02598063|Drug|Lamivudine|Lamivudine tablets will be administered orally at a dose of 10 mg QD for 12 weeks.
16039740|NCT02598063|Drug|Peginterferon alfa-2a|Peginterferon alfa-2a injection will be administered at a dose of 180 mcg QW for 48 weeks.
16039741|NCT02598050|Other|No Interventions as this is a observational study|
16039742|NCT02598037|Dietary Supplement|Test meal|The test meal will contain the following features: 50% carbohydrate, 20% protein and 30% of total fat, and will be admnistrada after drawing blood fasting for 12 hours.
16039743|NCT02598024|Behavioral|Narrative Exposure Therapy|In Narrative Exposure Therapy the patient constructs a narration of his or her life, focusing on the detailed context of the traumatic experiences as well as on the important elements of the emotional networks and how they go together. This process allows the majority of persons to recognise that the fear/trauma structure results from past experiences and that its activation is just a memory. They thus lose the emotional response to the recollection of the traumatic events, which consequently leads to a remission of PTSD symptoms. Thus, they gain access to 'lost' past memories and develop a sense of coherence, control, and integration. Revised Narrative Exposure Therapy (NET-R, Zang et al, 2013) is a 4-session treatment delivered within a week.
16039744|NCT02598024|Behavioral|Control Focused Behavioural Treatment|The Control-focused Behavioural Treatment (CFBT, Başoğlu et al 2005) for earthquake survivors was designed after 1999 Turkey earthquake as an intervention to facilitate natural recovery processes by restoring sense of control over anxiety, fear, or distress. Its underlying principle is to reduce helplessness responses by encouraging behaviours that are likely to enhance sense of control over stressor events and life in general. Its primary aim is to reverse traumatic stress processes by increasing anxiety or distress tolerance. In earthquake survivors, CFBT involves a single session in most cases and an additional few sessions in cases that do not respond to the initial session.
16039745|NCT02598011|Biological|Toca 511|Toca 511 consists of a purified retroviral replicating vector encoding a modified yeast cytosine deaminase (CD) gene. The CD gene converts the antifungal 5-flurocytosine (5FC) to the anticancer drug 5-FU in cells that have been infected by the Toca 511 vector
16039746|NCT02598011|Drug|Toca FC|"Toca FC is an extended-release formulation of flucytosine. Toca FC is supplied as 500 mg white, oblong tablets with TOCA FC embossed on one side and 500 embossed on the other side"
16039747|NCT02597998|Drug|14C-BI 409306|
16039748|NCT02597985|Other|Prehabilitation|Supervised exercise training intervention will include three sessions per week for four weeks at a Mayo Clinic system cardiac rehabilitation facility. The Rochester, Minnesota Cardiac Rehabilitation Program will provide guidance and oversight. Modes of aerobic exercise will include treadmill walking (the primary mode of training) supplemented with non-weight-bearing activities such as stationary cycling and combination arm/leg recumbent exercise (NuStep device), as needed. Intensity will be set using Borg Perceived Exertion Scale (RPE) ratings of 12-14 (somewhat hard), keeping patients below the threshold for more than mild angina.
16039749|NCT02597985|Other|Usual Care|
16039750|NCT02597972|Procedure|Fracture repair|
16039751|NCT02597972|Procedure|Fracture repair with joint replacement|
16039752|NCT02597946|Drug|afatinib|
16039753|NCT02597946|Drug|paclitaxel|
16039754|NCT02597933|Drug|Nintedanib|
16039755|NCT02597933|Drug|Placebo|
16039756|NCT02597907|Drug|aprepitant|aprepitant 80 mg is given to all patients before surgery
16039757|NCT02597907|Drug|palonosetron|palonosetron 0.075 mg is given to patients in the aprepitant plus palonosetron group after induction of general anesthesia
16039758|NCT02597907|Drug|Ramosetron|ramosetron 0.3 mg is given to patients in the aprepitant plus ramosetron group after induction of general anesthesia
16039759|NCT02597894|Procedure|Biopsy of Prostate|Undergo biopsy
16039760|NCT02597894|Other|Laboratory Biomarker Analysis|Correlative studies
16039761|NCT02597868|Drug|Capecitabine|Capecitabine is be given as a sequential treatment in Metastatic breast cancer patients who are got benefit in chemo treatment.
16039762|NCT02597868|Procedure|endocrine therapy|endocrine therapy is be given as a sequential treatment in Metastatic breast cancer patients who are got benefit in chemo treatment,the medicine will be confirmed by the patient's past-treatment.
16039763|NCT02597855|Drug|Aflibercept|Total 4 times of intravitreal aflibercept injection was performed
16039764|NCT02597855|Drug|Indocyanine green angiography (intraveonus indocyanine green dye)|At initial visit, indocyanine green angiography was performed. After 1 month of third Aflibercept injection, indocyanine green angiography was performed to evaluate polyp closure.
16039765|NCT02597842|Device|TEAS (transcutaneous electrical acupoint stimulation)|Electric stimulation was given through electrode attached to specific acupoints
16039766|NCT02597829|Drug|Certolizumab Pegol|Subcutaneous Injection
16039767|NCT02597816|Radiation|Three dimensional ultrasound|
16039768|NCT02597803|Drug|RGN-259|A preservative-free, sterile eye drop solution containing Tβ4 for direct instillation into each eye, four times a day (QID) for 28 days
16039769|NCT02597803|Drug|Placebo|It is composed of the same excipients as RGN-259 but does not contain Tβ4
16039770|NCT02597777|Other|Acetyl Hexapeptide-8|Acetyl-Hexapeptide-8 peptide solution will be diluted to a final concentration of 10% using Cetaphil facial lotion base
16039771|NCT02597777|Other|Placebo vehicle|Water will be diluted to a final concentration of 10% using Cetaphil facial lotion base.
16039772|NCT02597764|Behavioral|Diaphragmatic Breathing|
16039773|NCT02597764|Behavioral|Standard Urotherapy|
16044588|NCT02563847|Dietary Supplement|1.56 g L-Leucine|
16039774|NCT02597751|Behavioral|Cognitive Orientation to Occupational Performance (CO-OP)|"CO-OP is a cognitive approach to solving functional motor problems (Polatajko et al., 2001b). Therapists teach children a global problem solving strategy (Goal-Plan-Do-Check) as a framework for developing specific strategies for overcoming motor problems; these strategies are determined after a dynamic performance analysis by the therapist to determine where the breakdown is in performing the task. Occupational therapists will see children once weekly for one hour over 10 weeks as per published protocol (Polatajko et al., 2001b), plus two assessment sessions. Children will select three functional motor goals to be addressed over the course of treatment, rating their performance and satisfaction of these goals pre- and post-intervention."
16039775|NCT02597738|Other|Fresh tissue biopsy|Fresh tissue biopsy will be collected.
16039776|NCT02597738|Other|Blood/Urine Sample Collection|A one time blood sample will be collected.
16039777|NCT02597712|Drug|YF476|gastrin receptor antagonist
16039778|NCT02597712|Drug|YF476 placebo|placebo
16039779|NCT02597699|Drug|Remifentanil + Lidocaïne|
16039780|NCT02597699|Drug|Sufentanil + Lidocaïne|
16039781|NCT02597686|Behavioral|SD-PB training|
16039782|NCT02597673|Other|Home Exercise Program (HEP)|All participants will receive a standard home-based exercise rehabilitation protocol for PFPS. HEP teaches muscle strengthening exercises and self-management strategies to prevent recurrence. This program includes sessions with the study coordinator. A handout and given a demonstration of the daily exercises to be performed at home and weekly communication from the study coordinator regarding compliance with the exercises.
16039783|NCT02597673|Device|NMES|To ensure consistent interventions across participants, a specified percentage of baseline maximal voluntary contraction (% MVC) will be used to determine the intensity of the training contraction. The electrical amplitude to obtain the desired intensity will be determined for each participant. Participants will train at 20-30% of MVC during weeks 1-3, 30-40% of MVC during weeks 3-6, and 40-50% of MVC during weeks 6-9. Incremental increases will be made at the 3 and 6 week clinic visits. Individualized instructions for adjusting the amplitude dial settings, with a return demonstration, will be used to maintain the appropriate percentage of MVC. During the home training sessions, participants will adjust the amplitude required to achieve the desired goal, as tolerated.
16039784|NCT02597673|Device|TENS|The TENS protocol consists of 20-minutes of TENS stimulation while concurrently performing the HEP. The TENS with HEP and HEP alone will be alternated for 9 weeks. The Active device delivers a pre-set program of pulsed electrostimulation using a patented asymmetrical simple modulated pulse (SMP) waveform. SMP delivers a group of pulses as a repeating 12-second cycle.
16039785|NCT02597660|Drug|Somatropin|Active drug
16039786|NCT02597660|Drug|Bacteriostatic saline|Placebo, the diluent used to reconstitute somatropin
16039787|NCT02597660|Other|Progressive exercise program|Over a 12 week period beginning at the second study visit patients will perform a standard of care eccentric exercise training regime. Each session consists of three bilateral exercises: leg press, back squat, and hack squat. Subjects will complete four sets in each exercise with a 2-3 minute rest between sets. The repetitions/loads are: 15 repetition maximum (RM) week 1, 12RM weeks 2-3, 10RM weeks 4-5, 8RM weeks 6-8 and 6RM weeks 9-12. All exercises are performed from complete 0º to 90º of knee flexion and back again. Each of the eccentric and concentric phases will occur over a period of 3 seconds, respectively for a total of 6 seconds per contraction.
16039788|NCT02597660|Procedure|Patellar tendon biopsy|Bilateral biopsies will be performed on an elective basis, although the investigators will aim to have 8 subjects in each group receive the biopsy. Biopsies will be obtained at the 26 week time point. The data obtained from the biopsy will help address the mechanism behind observed changes in outcome scores, physical measurements or imaging studies. The biopsy will be performed under ultrasound guidance and using sterile technique with a disposable 14G, 2cm biopsy instrument.
16039789|NCT02597647|Biological|LAIV|Subjects underwent nasal swabs, nasopharyngeal saline wash, and nasal brushings pre, and 1-2 weeks and 4-6 weeks following intranasal administration of LAIV.
16039790|NCT02597647|Other|Saline|Subjects underwent nasal swabs, nasopharyngeal saline wash, and nasal brushings pre, and 1-2 weeks and 4-6 weeks following intranasal administration of saline nasal spray.
16039791|NCT02597634|Drug|SST-0225|SST-0225 is a cream formulation for topical application. Each 5.4 g dose is formulated to topically deliver 400 mg of ibuprofen. The cream contains sodium ibuprofen and various salts.
16039792|NCT02597634|Drug|Placebo|Placebo IP will be the same vehicle as SST-0225 vehicle without the active ingredient, ibuprofen. It will be matched in appearance, smell, consistency, and color to SST-0225 topical ibuprofen cream.
16039793|NCT02597621|Other|no intervention|no intervention
16039794|NCT02597608|Behavioral|CLP: Livelihoods|Capital for purchase of income generating asset, physical infrastructure (plinths, latrines, tubewells), livelihood maintenance stipend, monthly asset maintenance cost stipend, agricultural livelihood training, non-agricultural livelihood training, financial training, health and nutrition training.
16039795|NCT02597608|Dietary Supplement|CLP: Nutrition|Counseling on breastfeeding and complementary feeding; five components micronutrients (iron 12.5 mg, folic acid 0.16 mg, zinc 5 mg, vitamin A 0.3 mg, vitamin C 30 mg) for children 7-23 months dosage of 120 sachets per year; 180 iron and folic acid tablets (60 mg iron and 400 mg folic acid) tablets to each pregnant woman after first trimester and up to 180 for each breastfeeding woman per year, as well as 104 tablets to each adolescent girl; deworming treatment for children aged 1-5 years, adolescent girls, pregnant women after first trimester; identification and referral of acute malnutrition; facilitation of government campaigns on nutrition.
16039796|NCT02597608|Behavioral|Shiree: Livelihoods|Financial training; input support for livelihoods (cropping, livestock, poultry, fishing, bamboo working, small businesses, tailoring etc.); capacity building (mobilising Self Help Groups, facilitating community based organizations (CBOs), skills transfer); innovation support (market linkage and access to value chains); credit and savings groups; support in mobilizing communities to advocate for their needs.
16039828|NCT02597413|Procedure|Catheterization|Women in this group will be systematically catheterized before leaving the delivery room.
16039829|NCT02597400|Drug|Metformin|"Metformin500 mg BID on Days 1-2, only the morning dose on Day 3. Metformin will be taken 30 minutes prior to meals;
~Metformin 500 mg BID and HMS5552 50 mg BID on Days 4-7, only the morning dose on Day 8. Metformin and HMS5552 will be taken 30 minutes prior to meals"
16039915|NCT02596763|Drug|Baclofen|Patient receiving an off-label baclofen treatment for alcohol use disorder for less than 1 month.
16039797|NCT02597608|Dietary Supplement|Shiree: Nutrition|Counseling on breastfeeding, complementary feeding, and sanitation; community discussions including adolescent girls on early and forced marriage; five components micronutrients (iron 12.5 mg, folic acid 0.16 mg, zinc 5 mg, vitamin A 0.3 mg, vitamin C 30 mg) for children aged 7-23 months; 180 iron and folic acid tablets (60 mg iron and 400 mg folic acid) tablets to each pregnant woman after first trimester and up to 180 for each breastfeeding woman per year, as well as 104 tablets to each adolescent girl; deworming treatment for children aged 1-5 years, adolescent girls, pregnant women after first trimester.
16039798|NCT02597608|Behavioral|UPPR: Livelihoods|Monetary support for communities to improve infrastructure (drains, footpaths, latrines and water dwells, access to roads and markets); financing for apprenticeships; grants for small businesses; education grants for girls; grants for urban food production activities; financial training; establishment of savings and credit groups; support for communities in advocating for their needs; microcredit; improving access to health facilities; improving housing conditions; provision of plinths.
16039799|NCT02597608|Dietary Supplement|UPPR: Nutrition|Counseling on breastfeeding, complementary feeding, and sanitation; community discussions including adolescent girls on early and forced marriage; five components micronutrients (iron 12.5 mg, folic acid 0.16 mg, zinc 5 mg, vitamin A 0.3 mg, vitamin C 30 mg) for children aged 7-23 months; 180 iron and folic acid tablets (60 mg iron and 400 mg folic acid) tablets to each pregnant woman after first trimester and up to 180 for each breastfeeding woman per year, as well as 104 tablets to each adolescent girl; deworming treatment for children aged 1-5 years, adolescent girls, pregnant women after first trimester.
16039800|NCT02597608|Other|UPPR: Control|No interventions provided.
16039801|NCT02597595|Other|spirulina|oral spirulina (tablet=500mg) will be given to patients for 3 months in a dose of 250 mg/kg/day (maximum 4 gm)
16039802|NCT02597582|Procedure|Neck dissection|The Small Jaw® handpiece (Small Jaw® with ForceTriad®; Covidien, Colorado, USA) was not only used as a dissection forceps but also served as a ligation device.
16039803|NCT02597569|Behavioral|CO-OP KT Exposure|"Patient participants who receive therapy from clinicians who have received CO-OP KT training will belong to the CO-OP KT Exposure group. Patient participants will not receive treatment that is different from the treatment being offered to patients who do not enroll in the study.
~The CO-OP KT intervention is directed at the inpatient rehabilitation team. They will be trained in Cognitive Orientation to daily Occupational Performance (CO-OP) and will also receive multi-faceted knowledge translation (KT) support."
16039804|NCT02597556|Drug|Albendazole|A single 400mg dose of Albendazole administered at 0, 3, 6, 9, and 12 months.
16039805|NCT02597556|Drug|Placebo|Matching placebo tablet administered at 0, 3, 6, and 9 months. At month 12, all participants will receive a single dose of 400mg Albendazole.
16039806|NCT02597543|Drug|Regadenoson|For use in stress myocardial perfusion imaging.
16039807|NCT02597543|Drug|Gadolinium|For use in both perfusion imaging and late gadolinium enhancement.
16039808|NCT02597543|Procedure|Cardiac MRI|Cardiac MRI will be the imaging modality for perfusion imaging, late gadolinium enhancement and obtaining mean T1 segmental values of the heart.
16039809|NCT02597530|Device|TEAS|According to ancient Chinese medical books, acupoints LI4,PC6 and ST36 are chosen and identified.TEAS in long-term group will be administered 30 minutes prior to anesthesia and continued until the end of the surgery. In short-term group,TEAS will be administered 30 minutes prior to anesthesia and ended at time of anesthesia.In sham group,electrodes will be pasted 30 minutes before anesthesia but without electrical stimulation.All patients will remove electrodes on surgery over.
16039810|NCT02597517|Device|Digital chromoendoscopy and magnification|After the gastric body mucosal evaluation with white light endoscopy, the Optical Enhancement chromoendoscopy and magnification will be used for a more detailed evaluation of the subepithelial capillary network, the collecting venules and mucosal pits
16039811|NCT02597504|Other|Pen and paper neuropsychological test|Will be administered for Construct Validity to determine agreement with Quick Test
16039812|NCT02597504|Device|Quick Test|Quick Test, computerized test will be administered to all subjects.
16039813|NCT02597491|Behavioral|TLC monthly|Tobacco longitudinal care monthly
16039814|NCT02597491|Behavioral|TLC quarterly|Tobacco longitudinal care quarterly
16039815|NCT02597491|Behavioral|MTM|Medication management therapy
16039816|NCT02597491|Behavioral|4 week assessment|4 week assessment
16039817|NCT02597491|Behavioral|8 week assessment|8 week assessment
16039818|NCT02597478|Drug|Fentanyl Sublingual Spray|"Low-dose Fentanyl Goup: 15-25% of the morphine equivalent daily dose (MEDD) sprayed into mouth and under tongue one hour after first Shuttle Walk Test.
~High-Dose Fentanyl Group: 35-45% of the morphine equivalent daily dose (MEDD) sprayed into mouth and under tongue one hour after first Shuttle Walk Test."
16039819|NCT02597478|Procedure|Shuttle Walk Test|Participants walk back and forth between 2 cones in an indoor hallway for up to 12 minutes. After one hour Fentanyl Spray delivered, then second walk test performed.
16039820|NCT02597478|Behavioral|Questionnaires|Questionnaire completed about any breathing problems or other symptoms participant may be having at baseline. End of study questionnaire asks which dose level of study drug participant thinks they received. Participant also completes a questionnaire about how study drug may have helped them and how satisfied they are with the study. It should take about 5 minutes to complete the questionnaire.
16039821|NCT02597478|Behavioral|Mental Ability Tests|After each walk test, participant completes 4 tests of their mental abilities. It should take 15 minutes total to complete these tests.
16039822|NCT02597478|Behavioral|Phone Call|Thirty days study visit participant called by study staff. This call should last about 10 minutes.
16039823|NCT02597465|Drug|SPARC1507|The administered dose is calculated based on the BSA calculated for the subject on Day 1 of the Cycle
16039824|NCT02597465|Drug|Reference1507|Investigators choice including chemotherapy or supportive therapy
16039825|NCT02597452|Device|intelligent Breast Exam, iBE|A bilateral iBE exam will be performed on the entire breast in addition to a clinical breast exam administered by a trained individual. If the patient is selected to participate in the inter-rater reliability portion of the study, the subject will undergo both the iBE and the clinical breast exams twice sequentially performed by two different separately trained individuals during the same visit.
16039826|NCT02597439|Drug|Omega-3 fatty acids|
16039827|NCT02597439|Other|Placebo|
16039910|NCT02596802|Device|FETO therapy|Fetoscopic surgery at 27 to 31 weeks and 6 days gestation.
16039830|NCT02597400|Drug|HMS5552|"Metformin 500 mg BID and HMS5552 50 mg BID on Days 4-7, only the morning dose on Day 8. Metformin and HMS5552 will be taken 30 minutes prior to meals;
~HMS5552 50 mg BID on Days 9 -12, only the morning dose on Day 13. HMS5552 will be taken 30 minutes prior to meals."
16039831|NCT02597387|Drug|Mitoxantrone HCL Liposome Injection|
16039832|NCT02597374|Device|EEG|A 45 mn EEG will be performed in each participants during action and action observation of each hand.
16039833|NCT02597361|Drug|Irbesartan|Irbesartan: 150 or 300 mg o.d. The up-titration of irbesartan from 150 mg to 300 mg o.d. occur during the first 8 weeks following randomization
16039834|NCT02597361|Drug|Placebo|Placebo o.d. to match 150mg or 300mg irbesartan tablets
16039835|NCT02597348|Procedure|Liver Transplantation|The patient of the arm LT+C are treated by experimental liver transplantation preceding the Non experimental standard chemotherapy (according to usual practices) .
16039836|NCT02597335|Radiation|Spectro-MRI|Spectro-MRI for D-2HG detection
16039837|NCT02597335|Other|Dosage of free circulating plasmatic DNA|
16039838|NCT02597335|Other|Dosage of D-2HG in the urine|
16039839|NCT02597322|Drug|AXITINIB|Axitinib is an oral, potent, and selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2, 3 It will be supplied as 1 mg and 5 mg film coated tablets for oral administration in light protecting bottles of 60 tablets.
16039840|NCT02597309|Drug|Canagliflozin|
16039841|NCT02597283|Device|Biguard sirolimus-eluting bifurcation stent system|PCI with Biguard sirolimus-eluting bifurcation stent system
16039842|NCT02597283|Device|Sirolimus-eluting stent system|PCI with sirolimus-eluting stent system
16039843|NCT02597257|Drug|Lidocaine HCl|lidocaine continuous infusion
16039844|NCT02597257|Drug|Normal saline|Normal saline continuous infusion
16039845|NCT02597244|Device|Percutaneous Extraforaminotomy|percutaneous dissecting of the lumbar extraforaminal and foraminal region with BS extraforamonotomy kit(BioSpine Co.,Ltd, Seoul, South Korea) under fluoroscopy
16039846|NCT02597231|Dietary Supplement|Melatonin|Melatonin is the dietary supplement we are using in delirium prevention.
16039847|NCT02597231|Other|Placebo|Patients in this group will receive a matching placebo pill.
16039848|NCT02597205|Behavioral|physician-facing app and patient-facing messages|A physician-facing app was designed to help physicians with recruiting and managing patients and with evidence-based medications prescription. Messages were also developed to send to patients to improve their medical adherence and modify lifestyle.
16039849|NCT02597192|Other|probiotic oral hygiene products with Bacillus (PIP, Chrisal)|products with Bacillus probiotics
16039850|NCT02597192|Other|oral hygiene products without Bacillus|products without Bacillus
16039851|NCT02597166|Drug|Ledipasvir/Sofosbuvir|Each tablet of Harvoni contains 90 mg ledipasvir and 400 mg sofosbuvir.
16039852|NCT02597153|Drug|Mitoxantrone HCL Liposome Injection|
16039853|NCT02597140|Drug|lidocaine|Patients in lidocaine group will be received an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous infusion of 2 mg/kg/hr lidocaine.
16039854|NCT02597140|Drug|normal saline|Patients in control group will be received an intravenous bolus injection of 1.5 mg/kg normal saline followed by a continuous infusion of 2 mg/kg/hr normal saline.
16039855|NCT02597140|Drug|propofol|Propofol will be administered using target controlled infusion during monitored anesthesia care to adjust 60 to 80 of bispectral index.
16039856|NCT02597127|Drug|ALN-PCSSC|ALN-PCSSC is a small interfering ribonucleic acid (RNA) that inhibits PCSK9 synthesis and is given as SC injections
16039857|NCT02597127|Drug|Normal Saline|Saline (sterile, normal, 0.9%) solution given as SC injections
16039858|NCT02597114|Drug|AGT-181|intravenous infusion over 3-4 hours
16039859|NCT02597101|Drug|Metformin|background drug
16039860|NCT02597101|Drug|saxagliptin|background drug
16039861|NCT02597101|Drug|AZD9668|study drug
16039862|NCT02597101|Drug|placebo|placebo for AZD9668 to be added to background drugs
16039863|NCT02597088|Other|Laboratory studies of the effect of human milk handling using a rage surface area bottle (study device)|Using laboratory studies of the effect of storage and heating on expressed human milk, the investigators will compare milk handled in regular bottle and bottle warmer and milk handled using the study device (large surface area bottle)
16039864|NCT02597075|Other|standard therapy + physical activity program|
16039865|NCT02597075|Other|standard therapy|
16039866|NCT02597062|Drug|Carfilzomib|
16039867|NCT02597062|Drug|Cyclophosphamide|
16039868|NCT02597062|Drug|Dexamethasone|
16039869|NCT02597049|Drug|Dulaglutide|Administered SC
16039870|NCT02597049|Drug|Placebo|Administered SC
16039871|NCT02597049|Drug|SGLT2 inhibitor|Administered orally as standard of care for type 2 diabetes
16039872|NCT02597049|Drug|Metformin|Administered orally as standard of care for type 2 diabetes
16039873|NCT02597036|Drug|LY3127804|Administered IV
16039874|NCT02597036|Drug|Ramucirumab|Administered IV
16039875|NCT02597036|Drug|Paclitaxel|Administered IV
16039876|NCT02597023|Drug|MitoQ|Mitoquinone pill, 20 mg/day
16039877|NCT02597023|Drug|Placebo|Placebo pill with inert excipient, 1 time/day
16039878|NCT02597010|Dietary Supplement|Dietary nitrate|140ml of nitrate rich beetroot juice provides 12.9mmol nitrate and will be consumed on a daily basis during the intervention by the study subjects.
16039879|NCT02597010|Dietary Supplement|Placebo|140ml of nitrate depleted beetroot juice provides 0.5mmol nitrate and will be consumed on a daily basis during the intervention by the study subjects.
16039880|NCT02596997|Drug|Brincidofovir|Up to 100mg Brincidofovir twice weekly, not to exceed a total dose of 200mg each week
16039881|NCT02596984|Drug|Caspofungin|Either preemptive, empirical or curative prescription of Caspofungin by one of the ICUs' attending physician. Caspofungin will be administered according to the international recommendation
16039911|NCT02596789|Device|"TMS Magpro®, Magventure Inc device"|
16039912|NCT02596776|Procedure|Fat biopsy|up to 16 biopsy samples will be taken from each subject
16039913|NCT02596776|Drug|Propranolol and fat biopsy|subset of subjects will receive propranolol and have fat biopsy performed
16039914|NCT02596776|Other|heavy water and fat biopsy|subset of subjects will be given heavy water and have fat biopsy performed
16039882|NCT02596971|Drug|Atezolizumab|Atezo-G-Benda: Atezolizumab 840 milligrams (mg) intravenously (IV) on Days 1 and 15 of Cycles 2-6, during induction treatment, followed by 840 mg IV on Days 1 and 2 of each month, starting with Month 1, during maintenance treatment. Atezo-G-CHOP: Atezolizumab 1200 mg IV on Day 1 Cycles 2-6, during induction treatment, followed by 840 mg IV on Days 1 and 2 of each month, starting with Month 1. Atezo-R-CHOP: Atezolizumab 1200 mg IV on Day 1 Cycles 2-8, during induction treatment, followed by 1200 mg IV on Day 1 of Cycles 9-25.
16039883|NCT02596971|Drug|Bendamustine|Bendamustine will be administered at a dose of 90 milligrams per square meter (mg/m^2) IV on Days 1 and 2 of Cycles 1-6, during induction treatment.
16039884|NCT02596971|Drug|Cyclophosphamide|Cyclophosphamide will be administered at a dose of 750 mg/m^2 IV on Day 1 of Cycle 1-6/8, during induction treatment.
16039885|NCT02596971|Drug|Doxorubicin|Doxorubicin will be administered at a dose of 50 mg/m^2 IV on Day 1 of Cycle 1-6/8, during induction treatment.
16039886|NCT02596971|Drug|Obinutuzumab|Atezo-G-Benda: Obinutuzumab will be administered at a dose of 1000 mg IV on Days 1, 8, and 15 of Cycle 1 and 1000 mg IV on Day 1 of Cycles 2-6, during induction treatment, followed by 1000 mg IV on Day 1 of every other month, starting with Month 1, during maintenance treatment. Atezo-G-CHOP: Obinutuzumab will be administered at a dose of 1000 mg IV on Days 1, 8, and 15 of Cycle 1 and 1000 mg IV on Day 1 of Cycles 2-6 during induction treatment, followed by 1000 mg IV on Day 1 of every other month, starting with Month 1 during maintenance treatment.
16039887|NCT02596971|Drug|Prednisone|Prednisone will be administered at a dose of 40 mg/m^2 orally on Days 1-5 of Cycle 1-6/8, during induction treatment. Prednisolone may be given if prednisone is unavailable. The 40 mg/m^2 dose of prednisone on Day 1 will be replaced by oral corticosteroids given as premedication on Day 1 of Cycle 1 (and subsequent cycles).
16039888|NCT02596971|Drug|Vincristine|Vincristine will be administered at a dose of 1.4 mg/m^2 (maximum 2 mg) IV on Day 1 of Cycle 1-6/8, during induction treatment.
16039889|NCT02596971|Drug|Rituximab|Atezo-R-CHOP: Participants with previously untreated DLBCL will receive rituximab at a dose of 375 mg/m^2 IV on Day 1 of Cycle 1-8, during induction treatment.
16039890|NCT02596958|Drug|Bevacizumab|Six 3-weeks cycle of IV bevacizumab will be administered for approximately 7 months.
16039891|NCT02596945|Drug|Methoxy polyethylene glycol epoetin beta|Methoxy polyethylene glycol epoetin beta is prescribed as per physician's discretion in accordance with the Summary of Product Characteristics (SmPC).
16039892|NCT02596932|Other|Standard Protocol for intrapartum glucose management|Tight glucose control protocol: Goal maternal blood glucose 70-100, q 1 hour blood glucose checks, insulin treatment started with single maternal blood glucose level > 100mg/dL or < 60mg/dL
16039893|NCT02596932|Other|Experimental Protocol for intrapartum glucose management|Less Tight: Goal maternal blood glucose 70-120, q 4 hour blood glucose checks (unless symptomatic), insulin treatment started with single maternal blood glucose > 120 mg/dL or < 60 mg/dL
16039894|NCT02596919|Other|photography|photography of meibomian glands
16039895|NCT02596906|Device|tDCS|Prior to the reasoning training, participants will undergo tDCS. Participants will receive 20 minutes of tDCS using 2mA or less targeting the inferior frontal gyrus prior to each of their 8 reasoning training sessions for a total of 160 total combined minutes. This time does not include set up time which should take no more than 5 minutes. A brief engaging film is shown to participants during the 20 minute session.
16039896|NCT02596906|Device|Sham tDCS|For the sham tDCS group, the device will be turned off after 30s. The only reported sensations from tDCS is an itching or a tingling when the device turns on but disappears quickly. Thus, those receiving sham tDCS will be unaware that the device has turned off, and will experience an initial tingling similar to that received in the tDCS group.
16039897|NCT02596893|Drug|GED-0301|
16039898|NCT02596893|Drug|Placebo|
16039899|NCT02596880|Drug|Sofosbuvir|400 mg, included in a combination pill (Sovodak) with 60 mg daclatasvir
16039900|NCT02596880|Drug|Daclatasvir|60 mg, included in a combination pill (Sovodak) with 400 mg sofosbuvir
16039901|NCT02596880|Drug|Ribavirin|1000 mg/day if <75 kg, 1200 mg/day for >75 kg. Divided into two daily doses
16039902|NCT02596867|Drug|propanolol|Participants will take 1.5 mg/kg/day propranolol, twice daily for 3 weeks until surgical resection of the breast tumor is performed
16039903|NCT02596854|Device|Neurological MRI|Neurological MRI image collection
16039904|NCT02596828|Drug|Temozolomide|"Pharmacotherapeutic Group: Antineoplastic agents - Other alkylating agents, ATC-Code: L01A X03 Excipients: Capsule content: Anhydrous lactose, Sodium starch glycolate Type A, Colloida anhydrous silica, Tartaric acid, Stearic acid. Capsule shell: Gelatine, Titanium dioxide (E171).
~Printing ink: Shellac Propylene glycol, Titanium dioxide (E171), Sunset yellow FCF Aluminium Lake (E110) Formulation: capsule, hard Route of Administration: orally; Temomedac hard capsules should be administered in the fasting state. The capsules must be swallowed whole with a glass of water and must not be opened or chewed"
16039905|NCT02596828|Drug|Irinotecan|Pharmacotherapeutic Group: cytostatic topoisomerase-I-inhibitor ATC-Code: L01XX19 Excipients: Sorbitol (E420), lactic acid, sodium hydroxid (to adjust the pH to 3.5), water for injection Formulation: concentrate for solution for infusion Route of Administration: intravenously
16039906|NCT02596828|Drug|Dasatinib|Pharmacotherapeutic Group: protein kinase inhibitor ATC-Code: L01XE06 Excipients: Tablet core: Lactose monohydrate, Cellulose, microcrystalline, Croscarmellose sodium, Hydroxypropyl cellulose, Magnesium stearate. Film-coating: Hypromellose, Titanium dioxide, Macrogol 400 Formulation: film coated tablet Route of Administration: orally. Patients should be instructed to swallow the tablets as a whole and not to split, chew, or crush them.
16039907|NCT02596828|Drug|Rapamycin|Pharmacotherapeutic Group: Immunosuppressive agents - mTOR Inhibitors ATC-Code: L04A A10 Excipients: Polysorbat 80, Phosal 50 PG ((3-sn-Phosphatidyl)cholin from Soy beans, Propylenglycol, lipid acid mono- and -diglyzeride from Soy oil, Ethanol (1,5% bis 2,5%), Soy liid acid and Palmitoyl ascorbic acid) Formulation: Oral solution Route of Administration:orally
16039908|NCT02596815|Procedure|Median Nerve Neural Mobilization|Nonsurgical noninvasive Median Nerve neural mobilization procedure was applied by a physical therapist continuously during 2 minutes in 5 different occasions with 1 minute of rest between each 2 minute application of the Neural Mobilization technique. The intervention was applied during a period of 6 weeks. The maximum level of elbow extension movement degree without the reproduction of symptoms during the application of the Median Nerve Neural mobilization treatment was determined through the baseline use of a Universal Goniometer Device.
16039909|NCT02596815|Device|Goniometer|
16039916|NCT02596750|Device|Microneedle Roller|200 micrometer length microneedles (MR2 roller, Clinical Resolution Laboratories, Inc.) mounted on a disposable roller
16039917|NCT02596750|Device|Sham microneedle Roller|Flat roller without microneedles
16039918|NCT02596737|Behavioral|wittyFit concept|
16039919|NCT02596724|Other|Genomic and/or molecular testing of blood or tissue|Genomic and/or molecular testing of blood or tissue
16039920|NCT02596711|Drug|Nicotine Patch|Participants receive 4 weeks of 21 mg, 4 weeks of 14 mg, and 4 weeks of 7 mg patches.
16039921|NCT02596711|Behavioral|Questionnaires|Questionnaires regarding tobacco and alcohol use, culture, religion, and sense of control completed at baseline, at weeks 2 and 6, and at 3 and 6 months after baseline.
16039922|NCT02596711|Other|Carbon Monoxide (CO) Test|Carbon monoxide (CO) test given at baseline, at weeks 2 and 6, and at 3 and 6 months after baseline.
16039923|NCT02596711|Behavioral|Health Education and Handouts|Participants receive general health education and handouts.
16039924|NCT02596711|Behavioral|Culturally Tailored Reading Materials|Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting.
16039925|NCT02596711|Behavioral|Counseling Sessions|Participants attend 3 counseling sessions during the study.
16039926|NCT02596685|Procedure|Bronchoscopy|Undergo bronchoscopy
16039927|NCT02596685|Other|Electronic Cigarette|Given nicotine-free and flavor-free electronic cigarettes
16039928|NCT02596685|Other|Laboratory Biomarker Analysis|Correlative studies
16039929|NCT02596685|Other|Questionnaire Administration|Ancillary studies
16039930|NCT02596672|Behavioral|The friendly walking group|A 12 week peer led walking group for adults and older adults (> 55 years) living in independent living communities in Northern Ireland. Designed to increase physical activity levels of inactive older adults and measure sustained changes in physical behaviour 6 months after the intervention ends.
16039931|NCT02596659|Procedure|Radial extracorporeal shock wave therapy (rESWT)|Each participant in the experimental group received rESWT for 3 sessions, consisting of 2000 impulses for each session, and one session per week over 3 weeks (a total of 6000 shock waves were given). The pneumatic pressure was set at the maximum level tolerable for each patient. The frequency of pulses was set at 10 Hz.
16039932|NCT02596659|Procedure|sham shockwave therapy|Sham shockwave therapy were given by the same physiatrist using the same machine as the experimental group, with the same rESWT protocol (3 sessions, 2000 impulses for each session, one session per week over 3 weeks) and the same frequency (10 Hz) of impulses, but the pneumatic pressure was set at 0.1 bar, with a similar sound to the regular rESWT but without actual energy conduction.
16039933|NCT02596659|Procedure|Physical therapy|The physical therapy program was performed 3 times a week over the same 3 weeks as rESWT, and consisted of 5 minutes of ultrasound diathermy, 15 minutes of transcutaneous electrical nerve stimulation (TENS), and 10 minutes of therapeutic exercise, including wrist common extensor stretching and self-massage.
16039934|NCT02596646|Procedure|Early Precut|Early precut was performed during ERCP with difficult biliary cannulation
16039935|NCT02596646|Procedure|Prolonged cannulation attempts|Prolonged cannulation attempts was performed during ERCP with difficult biliary cannulation
16039936|NCT02596633|Behavioral|Telephone-support Acceptance and Commitment Therapy (ACT)|Telephone-support Acceptance and Commitment Therapy (ACT): ACT self-help book and 8 telephone support calls
16039937|NCT02596620|Drug|Nexium|Esomeprazole (Nexium)(40 mg) 1 tablet twice daily for 10 days in both arms
16039938|NCT02596620|Drug|Amolin|Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for the first 5 days in the Sequential arm; Amoxicillin (Amolin)(500 mg) 2 tablets twice daily for 10 days for triple therapy arm
16039939|NCT02596620|Drug|Cravit|Levofloxacin(Cravit)(500 mg) 1 tablet once dialy for the last 5 days in the sequential arm and 1 tablets once daily for 10 days in the triple therapy arm
16039940|NCT02596620|Drug|Flagyl|Metronidazole (Flagyl)(250 mg) 2 # tid for the last 5 days in the sequential arm
16039941|NCT02596594|Device|fetal nutrition port system|Under local anesthesia a subcutaneous pouch for the port capsule was prepared using a pair of scissors. The umbilical vein was punctured with a 18 gauge needle under ultrasound control and the catheter was inserted into the umbilical vein. Note the amniotic cavity remained intact. A 25 gauge port needle was used to enter the port system. The treatment course included daily infusions of AA solution (Fresenius Kabi, Bad Homburg, Germany) with a 10% glucose solution. The investigators limited the volume of the intraumbilical infusion to 10% of the estimated feto-placental blood volume per day. On average, the AA/glucose-infusion was below 50 ml/kg.
16039942|NCT02596581|Other|non-surgical periodontal treatment|scaling and root planing were performed
16039943|NCT02596568|Device|transcranial direct current stimulation (tDCS)|tDCS is a type of brain stimulation that uses low current applied directly over the scalp to increase, or decrease cortical activity under the stimulating electrodes. tDCS applied bi-frontally using Chattanooga Ionto™ Iontophoresis System - Phoresor. A square wave will be delivered at 0.75 Hz for five blocks of five minutes each with one minute inter-train interval. Stimulation will be applied following 8 epochs of consecutive stage 2 or deeper sleep.
16039944|NCT02596568|Other|Sham|tDCS device connected and tested, but not turned on during the night. This has been found to be an effective sham in other studies using this technique.
16039945|NCT02596555|Drug|Dabigatran|Low molecular weight heparin for 72 hours followed by 6 months of dabigatran
16039946|NCT02596542|Other|Water immersion|Different temperatures of cold water immersion will be assessed
16039947|NCT02596529|Device|Fixation|Fixation of the posterior malleolus with lag-screws or platefixation (usually by Drittelrohr plate).
16039948|NCT02596529|Other|NO Fixation|NO Fixation of the posterior malleolus.
16039949|NCT02596503|Drug|Eribulin|Intravenous eribulin administered on days 1 and 8 of a 21-day cycle.
16039950|NCT02596503|Drug|Irinotecan|Irinotecan will be administered orally at a fixed dose of 90 mg/m2/day on days 1 -5 of a 21-day cycle.
16039951|NCT02596503|Other|Cefixime|Cefixime will be given to all patients to reduce irinotecan-associated diarrhea. It will be administered Day -1 through Day 8 of each cycle.
16040036|NCT02595879|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16040037|NCT02595879|Other|Laboratory Biomarker Analysis|Correlative studies
16040038|NCT02595879|Other|Pharmacological Study|Correlative studies
16040039|NCT02595879|Drug|Triapine|Given IV and PO
16039952|NCT02596490|Behavioral|Questionnaires|"Phase 1: At end of second meditation and discussion session, couples complete complete a written review about the program in general and a questionnaire about their general health and well-being.
~Phase 2: Couples complete 12 questionnaires before first meditation and discussion session. Questionnaires ask about participant's health, mood, level of fatigue, sleeping habits, their relationship, and quality of life. Same questionnaires completed 1 week after mediation sessions.
~Phase 3: Participant complete 13 questionnaires before first mediation session, after last session, and again 3 months later. Questionnaires ask about participant's health, any symptoms they may be having, mood, level of fatigue, sleeping habits, their relationship, and their quality of life. Partners complete 12 questionnaires about their health, mood, level of fatigue, sleeping habits, their relationship, and their quality of life. AC group completes same questionnaires with no intervention."
16039953|NCT02596490|Behavioral|Meditation and Discussion Sessions|"Phase 1: Participant and partner attend 2 meditation sessions with a mediation trained instructor. Each session will last about 60-90 minutes.
~Phase 2 and 3: Participant and partner attend meditation class with a trained meditation instructor each week for 4 weeks. Each session will last about 60 minutes total. Meditation and discussion sessions videotaped."
16039954|NCT02596490|Behavioral|Cancer-Related Discussion Program|Phase 3: Participant and partner attend 1 discussion session each week for 4 weeks with a trained interventionist. During the discussion sessions, participants discuss issues for couples coping with cancer. Each session will last about 60 minutes.
16039955|NCT02596477|Drug|Vepoloxamer|
16039956|NCT02596477|Other|5% dextrose in water|
16039957|NCT02596451|Drug|Diclofenac Sodium gel, 1%|
16039958|NCT02596451|Drug|Voltaren® Gel|
16039959|NCT02596451|Drug|Placebo|
16039960|NCT02596438|Other|Hepatitis B|Hepatitis B Surface Antigen, Hepatitis B Surface Antibody and Hepatitis B Core AB, Total Testing
16039961|NCT02596425|Procedure|40 cmH2O|The intervention was five manual inflations of the lungs with positive pressure ventilation of 40 cmH2O at the end of surgery.
16039962|NCT02596425|Procedure|60 cmH2O|The intervention was five manual inflations of the lungs with positive pressure ventilation of 60 cmH2O at the end of surgery.
16039963|NCT02596425|Procedure|Passive deflation|In the controls, CO2 was removed by the traditional passive deflation of abdominal cavity.
16039965|NCT02596399|Drug|DSTA4637S|Participants will receive DSTA4637S intravenously on Day 1.
16039966|NCT02596399|Drug|Placebo|Participants will receive placebo matched to DSTA4637S intravenously on Day 1.
16039967|NCT02596386|Procedure|sialometry|potassium evaluation
16039968|NCT02596386|Procedure|blood test|potassium evaluation
16039969|NCT02596373|Drug|Mitoxantrone Hydrochloride Liposome Injection|
16039970|NCT02596360|Drug|Pulmodexane® 30mg|The study design is divided in two study sequences and each subject participates in the two study sequences and receive the two treatments (dextromethorphan and placebo).
16039971|NCT02596360|Drug|lactose|The study design is divided in two study sequences and each subject participates in the two study sequences and receive the two treatments (dextromethorphan and placebo).
16039972|NCT02596347|Procedure|Blood draw|We will draw 4 heparin tubes for peripheral blood mononuclear cells (PBMC)
16039973|NCT02596347|Procedure|bronchoscopy|CBD subjects will undergo a bronchoscopy with lavage. This is the passage of a think flexible tube through the nose into the windpipe then into the bronchial tubes. Sterile saltwater solution is through the flexible tube then immediately removed.
16039974|NCT02596334|Drug|dolutegravir 50mg +abacavir 600mg +lamivudine 300mg|
16039975|NCT02596334|Drug|dolutegravir|
16039976|NCT02596321|Drug|Mitizax|Allergen extract
16039977|NCT02596321|Drug|Placebo|Placebo tablet
16039978|NCT02596308|Biological|Plague vaccine|Plague vaccine is comrised by native fraction 1 capsule (F1) and recombine virulence-associated (V) antigens.
16039979|NCT02596282|Procedure|Neonatal circumcision under topical anesthesia|"The standard procedure for neonatal circumcision is as follows: combined analgesia was topical 2.5% lidocaine and 2.5% prilocaine <1 gm applied 60 minutes and 40mg acetaminophen suppository 30 minutes prior to surgery. Infants were given a 24% sucrose solution pacifier if needed. Infants under 2 weeks of age received subcutaneous Vitamin K 1 mg. The perineum cleaned, and the penis swabbed with povidone iodine. Hemostats were applied at 3 and 9 o'clock positions and the glans pushed down. Traction was applied before placing the Mogen clamp, the clamp was closed for 5 minutes and the foreskin removed with a scalpel.
~Petroleum jelly (e.g., Vaseline) was applied to the glans and the wound covered with sterile gauze. Infants were observed for one hour. Mothers were instructed in wound care."
16039980|NCT02596269|Drug|Nefopam|120 mg of nefopam is included in the i.v. PCA with with 100 ml solution containing 1250 µg fentanyl. a bolus of 1 ml with an 8-min lockout time was set, without any background continuous infusion. After the end of surgery, and if the goal VRS score was achieved at PACU, PCA device was turned on and the patient was encouraged to use the pre-set bolus dose, until 24h after the end of surgery.
16039981|NCT02596269|Drug|Saline|i.v. PCA with with 100 ml solution containing 1250 µg fentanyl. a bolus of 1 ml with an 8-min lockout time
16039982|NCT02596256|Drug|Apatinib|Apatinib (500 mg qd p.o.) until disease progression or intolerable toxicity
16039983|NCT02596256|Drug|Docetaxel|Docetaxel (60 mg/m2 qd d1 q3w i.v.) until disease progression or intolerable toxicity
16039984|NCT02596243|Biological|GX-188E|1mg of GX-188E administered IM using EP device at day 0, week 4 and week 12.
16039985|NCT02596243|Biological|Placebo|0.5mL of Placebo administered IM using EP device at day 0, week 4 and week 12.
16039986|NCT02596217|Drug|ABBV-066|SC injection
16039987|NCT02596217|Drug|ABBV-066|IV infusion
16039988|NCT02596217|Drug|Placebo|SC injection (stage 1)
16039989|NCT02596217|Drug|Placebo|IV infusion (stage 2)
16040088|NCT02595528|Drug|AGN-190584 ophthalmic solution|1 drop AGN-190584 ophthalmic solution doses A, B and C in the eye.
16040089|NCT02595528|Drug|AGN-190584 vehicle|Vehicle to AGN-190584
16039990|NCT02596204|Other|Weekly Review|Subjects will wear a FitBit activity monitor and continue to use their insulin pump. Fitbit, pump and sensor (if applicable) data will be uploaded at least weekly. For subjects in the weekly review group, research staff (CDE, NP and/or MD) will review uploaded blood glucose, pump, and available sensor, activity and sleep data on a weekly basis. If glucose patterns are identified which suggest a change to diabetes management (ie insulin dose changes), the family will be contacted by text, email or telephone to review glucose patterns and to review staff recommendations.
16039991|NCT02596204|Device|FitBit|All subjects will wear a FitBit activity monitor.
16039992|NCT02596191|Other|Clinical evaluation|
16039993|NCT02596191|Other|electrophysiological record|
16039994|NCT02596191|Other|Muscle MRI|
16039995|NCT02596191|Other|blood samples analysis|
16039996|NCT02596178|Device|Electrical Impedance Tomography|Electrical impedance tomography capitalizes on changes in electrical impendence between air-filled versus tissue or fluid-filled spaces in order to characterize and quantify regional distribution of lung volume at the bedside.
16039997|NCT02596165|Device|Pulse wave analysis measurement with Schiller BR-102 Plus PWA device|Measurement of central and peripheral blood pressure and central arterial stiffness simultaneously with the Schiller BR-102 Plus PWA device
16039998|NCT02596152|Other|mini-trampoline|Intervention period lasts 12 weeks, training is group instructed, twice weekly. Training sessions are one hour each. The training intensity of the two interventional arms is comparable. The training progression is defined in advance.
16039999|NCT02596152|Other|Nordic Walking|Intervention period lasts 12 weeks, training is group instructed, twice weekly. Training sessions are one hour each. The training intensity of the two interventional arms is comparable. The training progression is defined in advance.
16040000|NCT02596139|Other|No Interventions|
16040001|NCT02596126|Drug|Cardiovascular Polypill|"Cardiovascular Polypill contains Aspirin, Atorvastatin and Ramipril.
~Participants will receive one of the following cardiovascular polypill:
~(A) Aspirin 100 mg, Atorvastatin 40mg, and Ramipril (2.5 mg, or 5 mg, or 10mg).
~or
~(B) Aspirin 100 mg, Atorvastatin 20mg, and Ramipril (2.5 mg, or 5 mg, or 10mg)."
16040002|NCT02596126|Drug|Treatment Prevention for Secondary CV|ESC Guideline (2013 guideline on management of stable coronary disease) recommended pharmacological treatment for event prevention.
16040003|NCT02596100|Drug|Betrixaban|
16040004|NCT02596087|Other|Problem List Suggestion|Sites will configure their EHR systems so that alerts for these conditions will be triggered for providers in the intervention arm if the patient does not have the condition on her/his problem list. each alert will be actionable and allow the provider to add the problem to her or his patient's problem list with a single click. The provider will also be able to override the rule of the patient does not have the condition (in which case the alert will not be displayed again unless new information that would trigger the alert is added to the patient's record), or defer the alert until later.
16040005|NCT02596074|Drug|Omiganan (CLS001) topical gel|
16040006|NCT02596074|Drug|Vehicle topical gel|
16040007|NCT02596061|Behavioral|Deposit Contract|Contracts prompt patients to put money they have earned at stake on a commitment to remain smoke-free for a longer period of time.
16040008|NCT02596061|Other|Incentives|Patients receive incentives for completing smoking cessation activities.
16040009|NCT02596048|Other|Iomeron|Iomeron or Imeron which is a iomeprol injection, hereafter referred to as iomeprol is an injectable solution of iomeprol, a non-ionic hydrosoluble iodinated compound used as a medical imaging contrast agent for radiological examinations.
16040010|NCT02596035|Drug|Nivolumab|
16040011|NCT02596022|Drug|CI-581a|a 50 minute infusion 24 hours prior to cocaine self-administration session
16040012|NCT02596022|Drug|CI-581b|a 50 minute infusion 24 hours prior to cocaine self-administration session
16040013|NCT02596009|Device|Breezhaler®|No active drug or placebo were administered to patients during this study. Each patient were required to inhale via all three (03) study devices (Breezhaler®, Ellipta® and Handihaler®). Each patient was required to produce at least three (03) inhalational profiles via each inhalational device, following the training and demonstration for correct inhalational procedure, for each device.
16040014|NCT02596009|Device|Ellipta®|No active drug or placebo were administered to patients during this study. Each patient were required to inhale via all three (03) study devices (Breezhaler®, Ellipta® and Handihaler®). Each patient was required to produce at least three (03) inhalational profiles via each inhalational device, following the training and demonstration for correct inhalational procedure, for each device.
16040015|NCT02596009|Device|Handihaler®|No active drug or placebo were administered to patients during this study. Each patient were required to inhale via all three (03) study devices (Breezhaler®, Ellipta® and Handihaler®). Each patient was required to produce at least three (03) inhalational profiles via each inhalational device, following the training and demonstration for correct inhalational procedure, for each device.
16040017|NCT02595983|Drug|Revusiran|500mg Revusiran by subcutaneous (sc) injection
16040018|NCT02595970|Drug|Secukinumab|weekly sub cutaneous injections of 300 mg during the first month and then monthly until week 52 plus extension until 03/11/2016.
16040020|NCT02595931|Drug|Berzosertib|Given IV
16040021|NCT02595931|Drug|Irinotecan Hydrochloride|Given IV
16040022|NCT02595918|Procedure|Metastasectomy|Undergo metastasectomy
16040023|NCT02595918|Procedure|Nephrectomy|Undergo nephrectomy
16040024|NCT02595918|Biological|Nivolumab|Given IV
16040025|NCT02595905|Drug|Cisplatin|Given IV
16040026|NCT02595905|Other|Laboratory Biomarker Analysis|Correlative studies
16040027|NCT02595905|Other|Placebo Administration|Given PO
16040028|NCT02595905|Drug|Veliparib|Given PO
16040029|NCT02595892|Drug|Berzosertib|Given IV
16040030|NCT02595892|Drug|Gemcitabine|Given IV
16040031|NCT02595892|Drug|Gemcitabine Hydrochloride|Given IV
16040032|NCT02595879|Radiation|Brachytherapy|Undergo LDR brachytherapy
16040033|NCT02595879|Drug|Cisplatin|Given IV
16040034|NCT02595879|Radiation|External Beam Radiation Therapy|Undergo pelvic EBRT
16040035|NCT02595879|Radiation|High-Dose Rate Brachytherapy|Undergo HDR brachytherapy
16040042|NCT02595853|Other|Non interventional study|All upper gastro-intestinal bleeding need endoscopic hemostasis. Endoscopic hemostasis conventional methods are injection of saline with epinephrine, placement of hemoclips and thermic or plasma coagulation. Hemospray™ will be sprayed onto bleeding lesions seen in endoscopy after failure of conventional methods or in salvage therapy at the discretion of endoscopists. Retrospective analysis of prospectively cellected data.
16040043|NCT02595840|Drug|Afatinib|
16040044|NCT02595840|Drug|Pemetrexed|
16040045|NCT02595827|Other|Conditional Advice|Caretakers are told to return in 2-3 only (Conditional Advice) if the child's symptoms continue.
16040046|NCT02595801|Other|Surgery in early childhood|Surgical interventions in early childhood (prior to completion of Early Development Instrument)
16040047|NCT02595788|Other|Change from supine to prone position|Change from supine to prone position
16040048|NCT02595775|Other|Individualized A/F report|Individualized A/F report containing 9 colonoscopy quality measures.
16040049|NCT02595775|Other|A/F report plus a high intensity intervention|E.g. Master class in colonoscopy
16040050|NCT02595775|Other|A/F report plus a low intensity intervention|E.g. Access to a video/presentation on good colonoscopy technique followed by a post presentation assessment.
16040051|NCT02595775|Other|A/F report alone|
16040052|NCT02595749|Drug|Oxytocin|
16040053|NCT02595749|Drug|Placebo|
16040054|NCT02595736|Drug|Placebo (SC)|Administered SC
16040055|NCT02595736|Drug|LY3200327 (SC)|Administered SC
16040056|NCT02595736|Drug|LY3200327 (IV)|Administered IV
16040057|NCT02595736|Drug|Placebo (IV)|Administered IV
16040058|NCT02595723|Drug|Phenytoin 200 mg capsule|Phenytoin oral capsule was initiated on Day 1 and administered at 200 mg twice/day for four consecutive days (Days 1 - 4).
16040059|NCT02595723|Drug|Megestrol 800 mg liquid|Liquid megestrol 800 mg/was initiated on Day 2 and administered at 09:00 for three consecutive days (Days 2 - 4).
16040060|NCT02595723|Drug|Phenytoin-matched Placebo capsule|Phenytoin-matched oral Placebo capsule was initiated on Day 1 and administered for four consecutive days (Days 1 - 4).
16040061|NCT02595723|Drug|Megestrol-matched liquid Placebo|Megestrol-matched liquid placebo was initiated on Day 2 and administered at 09:00 for three consecutive days (Days 2 - 4).
16040062|NCT02595710|Other|skin punch biopsy collection|Four-mm skin biopsies from non-lesional skin will be acquired from the patients, processed using our published techniques with Bartonella biomarkers, and imaged using confocal microscopy.
16040063|NCT02595710|Other|Blood collection|Blood will be tested for presence of Bartonella DNA and Bartonella antibodies using the Alpha Proteobacterium Growth Medium (BAPGM) multi-platform testing, including liquid culture, enriched agar plating and molecular techniques.Blood smears will be analyzed for presence of intra-erythrocytic Bartonella spp. by immunostaining.
16040064|NCT02595710|Other|Urine sample collection|Urine samples will be collected and analyzed for Bartonella spp specific microRNAs.
16040065|NCT02595697|Behavioral|J-EMT for Toddlers with Autism|Children assigned to the J-EMT group will receive a total of 48, 1-hour direct intervention sessions over six months that will include teaching their parents to implement J-EMT procedures across daily activities.
16040066|NCT02595684|Drug|Tadalafil|Tadalafil capsules: 5 mg, one per day, at night, during 28 days.
16040067|NCT02595684|Drug|Placebo|Calcined magnesia capsules: one per day, at night, during 28 days.
16040068|NCT02595671|Other|Digital Super Coach|Receive Digital Super Coach during 12 weeks
16040069|NCT02595671|Other|Conventional face to face PA & dietitian|Receive 7 face-to-face contacts (dietary and physical activity advice)
16040070|NCT02595671|Other|Digital Super Coach + minimal coaching|Receive 3 face-to-face contacts (dietary and physical activity advice)
16040071|NCT02595671|Other|Waiting Group|Receive Digital Super Coach during 12 weeks, after 12 weeks of no treatment
16040072|NCT02595658|Dietary Supplement|Meal composition|
16040073|NCT02595658|Drug|Rapid-Acting Insulin Dose|
16040074|NCT02595645|Genetic|Polypectomy and NGS|NGS of 38 cancer-related genes, systems biological analyses, correlation genetics to pathology and clinical data
16040075|NCT02595632|Other|No intervention|
16040076|NCT02595619|Device|RRT plus ECCO2R|Patients with acute kidney injury will be treated with Renal replacement therapy associated to extracorporeal carbon dioxide removal in a single treatment
16040077|NCT02595606|Drug|0.3% Sodium Hyaluronate|five times per day for the intervention of eye drop
16040079|NCT02595580|Device|Glucopred|
16040080|NCT02595567|Device|Indwelling tunneled pleural catheter (ITPC)|ITPCs have been shown to successfully and safely control dyspnea in patients with malignant pleural effusions. Compared to the large amount of published data regarding the use of indwelling tunneled pleural catheters in malignant effusions, there is a paucity of data regarding the use of ITPC in liver disease for the treatment of hepatic hydrothorax.
16040081|NCT02595554|Radiation|Concurrent chemoirradiation|External beam radiation therapy (EBRT) with concurrent weekly platinum chemotherapy followed by brachytherapy
16040082|NCT02595554|Drug|Paclitaxel|New adjuvant chemotherapy 3 cycles with Paclitaxel 150mg/m2 over 3 hours and Cisplatin
16040083|NCT02595554|Procedure|Radical Surgery|Radical hysterectomy (Type III or Type IV hysterectomy) plus bilateral pelvic lymph node dissection and para-aortic lymph node dissection or sampling
16040084|NCT02595554|Drug|Cisplatin|New adjuvant chemotherapy 3 cycles with Paclitaxel and Cisplatin 70mg/m2
16040085|NCT02595541|Drug|milrinone|IV milrinone (0.75 mcg/kg) loading dose over one hour started during re-warming of the patient (before weaning from CPB) and followed by a maintenance dose of 0.75 mcg/kg/minutes till the end of the study.
16040086|NCT02595541|Drug|Sildenafil|IV milrinone (0.75 mcg/kg) loading dose over one hour started during re-warming of the patient (before weaning from CPB) and followed by a maintenance dose of 0.75 mcg/kg/minutes till the end of the study. After baseline measurements, sildenafil (1mg/kg) administered in ICU via a nasogastric tube, to be repeated every 4 hours via a nasogastric tube or orally. Sildnafil is presented in tablet form which was dissolved in water to make a concentration of 1 mg/ml.
16040087|NCT02595528|Drug|AGN-199201 ophthalmic solution|1 drop of AGN-199201 ophthalmic solution Doses A, B, C in the eye.
16040188|NCT02594761|Biological|Herceptin EU|Powder for Concentrate for Solution for Infusion, 150 mg/vial
16040090|NCT02595528|Drug|AGN-199201 + AGN-190584 Combination|1 drop AGN-199201 and AGN-190584 fixed combination ophthalmic solution in the eye.
16040091|NCT02595528|Drug|AGN-199201 vehicle|Vehicle to AGN-199201
16040092|NCT02595515|Other|Chiropractic treatment|Procedure: chiropractic treatment.
16040093|NCT02595515|Other|Visit without active treatment|Procedure: Visit without active treatment. The child is brought in for chiropractic treatment, but no active treatment is delivered. The parents are unaware whether the treatment is delivered or not.
16040094|NCT02595502|Device|JJVC Marketed Contact Lens (Test)|
16040095|NCT02595502|Device|Competitor Marketed Contact Lens (Control)|
16040096|NCT02595489|Dietary Supplement|vitamin D3|Daily oral supplement provided by study investigators
16040097|NCT02595476|Drug|Remifentanil|
16040098|NCT02595476|Drug|propofol|
16040099|NCT02595476|Device|TCI|
16040100|NCT02595476|Procedure|Tetanic stimulation|
16040101|NCT02595476|Device|Algiscan|Pupillometry
16040102|NCT02595463|Drug|Lidocaine|Intraoperative dose of intravenous lidocaine followed by an infusion until discharge from the initial recovery period.
16040103|NCT02595463|Drug|Saline|Intraoperative dose of saline followed by an infusion until discharge from the initial recovery period.
16040104|NCT02595450|Drug|Erlotinib|Participants with locally advanced or metastatic non-small cell lung cancer will be treated with erlotinib according to the product label. This non-interventional study will not affect by any means the treatment, medical care or monitoring of the participant, since it reports retrospective data, which already exist in the participants' medical files.
16040105|NCT02595437|Drug|Triferic|
16040106|NCT02595424|Drug|Capecitabine|Given PO
16040107|NCT02595424|Drug|Carboplatin|Given IV
16040108|NCT02595424|Drug|Cisplatin|Given IV
16040109|NCT02595424|Drug|Etoposide|Given IV
16040110|NCT02595424|Other|Laboratory Biomarker Analysis|Correlative studies
16040111|NCT02595424|Drug|Temozolomide|Given PO
16040112|NCT02595398|Drug|4mg CLS-TA Suprachoriodal Injection|CLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints
16040113|NCT02595398|Drug|Sham Procedure|Sham procedure administered at 2 timepoints
16040114|NCT02595385|Device|Cell Salvage|Reinfusion of shed blood during the operation
16040115|NCT02595385|Procedure|Retrograde Autologous Prime|Removal of fluid from the bypass circuit
16040116|NCT02595372|Drug|Omeprazole|
16040117|NCT02595359|Drug|Moxifloxacin|Moxifloxacin intracameral
16040118|NCT02595346|Drug|Hydroxychloroquine|"endothelial function is assessed by measuring the flow mediated dilatation of humeral artery in response to ischemia. the dilatation is evaluated by echotracking.
~glycocalyx thickness is measured by the study of sublingual microcirculation with SDF imaging.
~oxydative, inflammatory and coagulation parameters is assessed on plasma samples."
16040119|NCT02595346|Drug|placebo|"endothelial function is assessed by measuring the flow mediated dilatation of humeral artery in response to ischemia. the dilatation is evaluated by echotracking.
~glycocalyx thickness is measured by the study of sublingual microcirculation with SDF imaging.
~oxydative, inflammatory and coagulation parameters is assessed on plasma samples."
16040120|NCT02595333|Drug|Group SF1|primary cesarean section+postoperative analgesia with sufentanil plus flurbiprofen axetil group
16040121|NCT02595333|Drug|Group S1|sufentanil was administered for analgesia in primary cesarean section
16040122|NCT02595333|Drug|Group SF2|sufentanil and flurbiprofen was administered for analgesia in repeated cesarean section
16040123|NCT02595333|Drug|Group S2|sufentanil was administered for analgesia in repeated cesarean section
16040124|NCT02595320|Drug|Capecitabine|"Capecitabine will be given to participants in Arm A at 1500 mg PO BID for 7 days, followed by a 7 day rest (7-7).
~Capecitabine will be given to participants in group B at 1250 mg/m2 OR 1000 mg/m2 PO BID for 14 days, followed by a 7 day rest (14-7)."
16040125|NCT02595307|Behavioral|Pamphlet|Written pamphlet outlining the risks of surgery as discussed in consultation.
16040126|NCT02595294|Procedure|Cervical Lateral Glide neural mobilization|Non-surgical non-invasive Cervical Lateral Glide neural mobilization procedure was applied by a physical therapist continuously during 2 minutes in 5 different occasions with 1 minute of rest between each 2 minute application of the Neural Mobilization technique. The intervention was applied during a period of 6 weeks. The correct linear alignment of patient's cervical spine was determined through the baseline use of a Universal Goniometer Device in each application of Cervical Lateral Glide neural mobilization.
16040127|NCT02595281|Other|Experimental arm|"Serum samples are collected:
~at each neoadjuvant chemotherapy cycle
~before surgery
~at each adjuvant chemotherapy cycle
~at each injection of bevacizumab as maintenance therapy
~stop at the progression or after 24 months post chemotherapy"
16040128|NCT02595268|Drug|Pitavastatin|Participants will receive single oral dose of pitavastatin 1 milligram (mg) on Day 1 and Day 9.
16040129|NCT02595268|Drug|JNJ-63623872|Participants will receive JNJ-63623872 600 mg twice daily on Days 4 through 12.
16040130|NCT02595255|Other|No intervention|No intervention
16040131|NCT02595242|Drug|Cyclophosphamide|Cyclophosphamide 750 mg/m2 will be infused intravenously once 1-2 minutes in 20-30 ml saline on the first day during a treatment phase of 3 weeks.
16040132|NCT02595242|Drug|Vincristine|Vincristine 0.3-0.5 mg/ml will be infused intravenously once about 5 minutes in saline on the first day during a treatment phase of 3 weeks.
16040133|NCT02595242|Drug|Prednisone|Prednisone 100 mg/d will be taken orally on the first 1-5 day during a treatment phase of 3 weeks.
16040134|NCT02595229|Procedure|Pronator quadratus repair|Suturing of the pronator quadratus muscle
16040135|NCT02595216|Device|Profound System|The Profound system is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of submental laxity
16040136|NCT02595203|Drug|[14C-pos 1]-Debio 1450 BES Solution|A solution containing Debio 1450 bis ethanolamine salt (BES) radiolabelled with carbon-14 (14C) at position 1
16040137|NCT02595203|Drug|[14C-pos 25]-Debio 1450 BES Solution|A solution containing Debio 1450 BES radiolabelled with carbon-14 (14C) at position 25
16040138|NCT02595190|Procedure|sacral canal cyst microscopic tamponade|sacral canal cyst microscopic tamponade treatment
16040139|NCT02595190|Drug|gabapentin + tramadol|dose range：gabapentin 400-1200mg tid, tramadol 100-200mg bid
16040140|NCT02595190|Device|resting state functional magnetic resonance imaging (rfMRI)|First time:2 days before Surgery or Drug use; Second time:3 months after Surgery or Drug use; Third time:1 year after Surgery or Drug use
16040141|NCT02595177|Procedure|Cataract surgery with intraocular lens implantation.|Phacoemulsification under topical anesthesia with intraocular lens implantation.
16040142|NCT02595151|Device|CLE|The CLE procedure did not differ from that of conventional colonoscopy, except for the additional storage of pCLE images and videos in the gastric antrum.
16040143|NCT02595138|Drug|Zoledronic acid|
16040144|NCT02595125|Device|IUD|copper IUD or levonogestrel IUD insert by the conventional technique or by direct technique
16040145|NCT02595112|Other|Staphylococcus aureus carriage|Vestibulum nasi and posterior nasal cavity sampling with swabs and posterior nasal cavity sampling by endoscopic procedure during otorhinolaryngologic surgery
16040146|NCT02595099|Other|Mindfulness training|group-based training programme, 2.5 hours delivered weekly for 8 weeks
16040147|NCT02595086|Procedure|Laparoscopic PPG|Laparoscopy assisted pylorus-preserving gastrectomy with D1+ lymphadenectomy (exclude lymph node station No. 5) in Japanese classification.
16040148|NCT02595086|Procedure|Laparoscopic DG|Laparoscopic distal gastrectomy with D1+ lymphadenectomy in Japanese classification.
16040149|NCT02595073|Drug|DSXS|Active treatment
16040150|NCT02595073|Drug|Placebo|Placebo treatment
16040153|NCT02595047|Procedure|tissue/ organ prefabrication|tissue/ organ is prefabricated in vivo independent of exogenous factors for replacement/ reconstruction purposes
16040154|NCT02595034|Drug|Clindamycin and Benzoyl Peroxide Gel 1%5%|Clindamycin and Benzoyl Peroxide Gel 1%5% (Taro Pharmaceuticals Inc.)
16040155|NCT02595034|Drug|BenzaClin® Topical Gel|BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel (Sanofi Aventis, U.S.)
16040156|NCT02595034|Drug|Placebo|Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)
16040157|NCT02595021|Procedure|Total or Subtotal Colectomy|Resect all or most parts of the colon: with total or subtotal colectomy as a part of optimal cytoreductive surgery(residual disease <=0.5cm)
16040158|NCT02595021|Procedure|Other Bowel Resection|Resect part of the colon or small intestine: with other types of bowel resection as a part of optimal cytoreductive surgery(residual disease <=0.5cm)
16040159|NCT02595008|Drug|DSXS|Active treatment
16040160|NCT02594995|Drug|NBP|
16040161|NCT02594982|Other|intervention bundle (sedation, pain, mobilization and sleep)|"Sedation: Sedation after target RASS Pain: Implementing a pain guideline and CPOT for pain assessment. Mobilization: Implementing a guideline on early mobilization and a daily prescribed mobilization level.
~Sleep: Implementing a daily quite time and changing procedures to minimize noise during the night"
16040162|NCT02594969|Other|Bleach Bath and Moisturizers|All subjects will have one forearm in a bleach bath and the other forearm in a water bath for 10 minutes. Following the bath, skin barrier function will be evaluated. Secondly, moisturizers will be applied to the arms and the skin barrier will be evaluated overtime.
16040163|NCT02594956|Device|no nasogastric tube|
16040164|NCT02594956|Device|nasogastric tube|
16040165|NCT02594943|Device|Boston Scientific Large Capacity with needle Biopsy|The investigators will use a conventional biopsy forceps for taking tissue biopsies in the GI tract. In a randomized order 4 out of total 8 biopsies will be taken with the conventional biopsy forceps from the tumor tissue.
16040166|NCT02594943|Device|Endodrill 1A (BIBBInstruments, Lund, Sweden)|The investigators will use the Endodrill, a new device for endoscopic tissue sampling in the GI tract. In a randomized order 4 out of total 8 biopsies will be taken with the Endodrill instrument from the tumor tissue.
16040167|NCT02594930|Procedure|synovial biopsy of total knee arthroplasty|synovial biopsies are taken via two different techniques in the same patient to allow direct comparison of results
16040168|NCT02594917|Procedure|Right Heart Catheterization|Some participants (i.e., those that are willing and able) will undergo a Right Heart Catheterization to check Cardiopulmonary function.
16040169|NCT02594917|Other|Blood draw|Test and control group will be asked to give 20 ml of blood samples
16040170|NCT02594904|Drug|Yinzhihuang Oral Liquid|All the four groups will be given same treatment as being described in arm description.
16040171|NCT02594891|Device|endoscopic retrograde biliary drainage|A 8.5 F plastic stent with proximal flap （XinChang medical instrument co., LTD,Shanghai, China) will be inserted into common bile duct with standard procedure.
16040172|NCT02594891|Device|endoscopic nasobiliary drainage|A nose bile duct（XinChang medical instrument co., LTD,Shanghai, China) will be inserted into common bile duct with standard procedure.
16040173|NCT02594878|Drug|Pamidronatdinatrium|
16040174|NCT02594878|Other|Natrium chloride 9mg/ml|
16040175|NCT02594865|Dietary Supplement|Glucerna|Glucerna ® 1.5 kcal (Abbott, USA), the standard enteral formula used at our ICU and the investigational enteral feeding.
16040176|NCT02594865|Dietary Supplement|Fresubin|Fresubin ® Energy Fibre (Fresenius, UK), the control enteral feeding.
16040177|NCT02594852|Device|+ laser|Use of laser in the treatment
16040178|NCT02594839|Drug|Bone marrow mesenchymal stem cells|Bone marrow will be harvested in healthy donors followed by separation and cultivation of MSCs. Before infusion cells will be suspended in 400 mL saline
16040179|NCT02594839|Drug|Placebo|intravenous infusion of 400 mL saline
16040180|NCT02594826|Behavioral|Culturally appropriate intervention|Church-based educational intervention combined with navigation assistance
16040181|NCT02594826|Behavioral|General health education control|General health and cancer education
16040182|NCT02594813|Procedure|Biopsy or cold snare polypectomy|
16040183|NCT02594800|Drug|Rosuvastatin|standard or intensive dose rosuvastatin therapy based on other routine medication for stroke for 52 weeks.
16040184|NCT02594787|Dietary Supplement|Phosphorus|
16040185|NCT02594787|Dietary Supplement|Placebo|
16040186|NCT02594774|Other|Manipulative osteopathy|Osteopathic treatment (BMT) which works on the influence on the pressure distribution in the (especially abdominal) body cavities and consequently on the viscera contained therein, proper arterial supply and venous and limphatic drainage.
16040187|NCT02594761|Biological|Hercules|Powder Concentrate for Intravenous Infusion, 150 mg/vial
16040190|NCT02594748|Behavioral|Self-management education|The intervention group will receive diabetes self-management education based on the idea of extended theory of planned behavior .
16040191|NCT02594748|Behavioral|Routine care|They will attend the routine lecture in hospital sit and listen, usually 1-2 times during one week in hospital
16040192|NCT02594735|Drug|Abatacept|Study participation will consist of a screening visit and 5 protocol visits over six months (week 0, week 6, week 12, week 18, and week 24) for each subject, and phone follow-up (week 2, week 4, week 8, week 10, week 14, week 16, week 20, and week 22). At Visit 1, which will be treatment initiation, eligible subjects will be instructed on the use and side effects of subcutaneous abatacept and will be started on the study drug (abatacept 125 mg SQ weekly for subjects with body weight ≥ 50 KG or abatacept 87.5mg SQ for subjects with body weight < 50 KG).
16040193|NCT02594722|Device|FES-cycling|Patients performed an endurance tests with functional electrical stimulation during 30 minutes with an oxygen uptake measure.
16040194|NCT02594722|Device|Classic cycloergometer|Patients performed an endurance tests on classic ergometer during 30 minutes with a sham electrical stimulation with an oxygen uptake measure.
16040195|NCT02594709|Radiation|Multisession Radiosurgery|Patients will undergo multisession radiosurgery as clinical practice.
16040196|NCT02594696|Other|Proactive Psychiatry Consultation (PPC)|"The psychiatrist conducts a tailored, cancer-specific assessment to optimize psychiatric symptoms and collaborates with the oncologist to develop and modify the cancer treatment plan.
~The case manager, a social worker, engages with the patient to promote self-management, identify and address barriers to care, and bridge communication with oncology and mental health.
~The psychiatrist and case manager proactively monitor symptoms and the process of cancer care, remain in regular contact with the patient and communicate with the oncology team at least every 4 weeks
~The psychiatrist and case manager are available for consultation across care settings (outpatient, inpatient, home).
~Recommendations are documented in the medical record and communicated directly to the oncology team"
16040197|NCT02594670|Other|DU20 and HT7 combination|acupoints combination includes Baihui (DU20) and Shenmen(HT7),which was considered as the optimal clinical efficay among various combinations of acupoints.
16040198|NCT02594670|Other|DU20 and SP6 combination|acupoints combination of Baihui (DU20) and Sanyinjiao (SP6), which should have some clinical efficay among various combinations of acupoints.
16040199|NCT02594670|Other|DU20 and SA combination|Combination of Baihui (DU20) and a Sham acupoint (SA), which should have least clinical efficacy among these three types of acupoints combinations.
16040200|NCT02594657|Procedure|pedal rate on 50 RPM|All measurements are performed in two pedalling situations. The two frequencies used will be 50 and 80 RPM. For each subject the running order (50 and 80, 80 and 50) is randomly determined
16040201|NCT02594657|Procedure|pedal rate on 80 RPM|All measurements are performed in two pedalling situations. The two frequencies used will be 50 and 80 RPM. For each subject the running order (50 and 80, 80 and 50) is randomly determined
16040202|NCT02594644|Device|Microneedle Roller|The study device (MR200, Clinical Resolutions Laboratory, Inc.) is a disposable roller equipped with stainless steel needles that are 650 micrometers in length.
16040203|NCT02594644|Drug|Aminolevulinic Acid|Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
16040204|NCT02594644|Radiation|Blue Light|Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA
16040205|NCT02594631|Procedure|ESWL|Patients in this arm will receive ESWL for treatment of acute calcular urinary retention
16040206|NCT02594631|Procedure|Endoscopic treatment|Patients in this arm will receive endoscopic treatment of acute calcular urinary retention
16040207|NCT02594605|Device|Platelet Rich Fibrin|Platelet rich fibrin increases the growth factors. So it was applied for treatment of periodontal bone loss.
16040208|NCT02594605|Device|Conventional Flap Surgery|Only Conventional Flap Surgery treatment the bone loss limitedly.
16040209|NCT02594592|Other|questionaire|Arm: Experimental :questionaire medium risk, and high risk.(more than one positive answer about questionaire) Arm:Active Comparator: questionaire low risk (none of positive answer about questionaire)
16040210|NCT02594579|Drug|Vitamin D3|Vitamin D3 100,000 u per day on day 1,3 then 50,000 u/day on day 5,7,9,12 and continue 50,000 u 3 times/ week for 4 weeks
16040211|NCT02594579|Drug|Placebo|Placebo on day 1,3,5,7,9,12 then 3 times/ week for 4 weeks
16040212|NCT02594566|Drug|CyMVectin|CyMVectin will be delivered by unilateral intramuscular (IM) injection at Day 0, Day 28(+4 days), and Day 56 (+4 days) in alternating arms. Each dose of CyMVectin will be administered in a 1.0-mL volume
16040213|NCT02594553|Behavioral|GP-parent information-exchange tool|The booklet incorporates already existing information about fever, alarm symptoms, advices use of medication and specific infectious diseases that frequently occur in childhood in combination with fever such as upper respiratory tract infections, and otitis media. The difference with these existing sources of information is the fact that they until now, were not incorporated into one booklet which can be physically handed over to parents.
16040214|NCT02594540|Device|Mechanical Peripheral Stimulation (GONDOLA)|
16040215|NCT02594527|Other|Volunteer-led physical activity session|Participants will be encouraged by volunteers to walk or perform chair-based exercises during their stay in hospital
16040216|NCT02594501|Device|COBRA PzF|
16040217|NCT02594501|Device|Drug Eluting Stent|
16040218|NCT02594488|Device|Medtronic Reveal LINQ implantable cardiac monitor|The implantable cardiac monitor is implanted under the skin in the region of the thorax. It continuously monitors the heart's electrical activity for up to three years. Predefined arrhythmias are daily transmitted to a central core lab. In case of arrhythmias, specific guideline-based treatment is initiated within 48h.
16040219|NCT02594475|Procedure|Endoscopic retrograde cholangiopancreatography|"Endoscopic retrograde cholangiopancreatography is started using conventional duodenoscope (TJF 240 or 260V, Olympus Optical Co., Ltd, Tokyo, Japan) in randomly assigned left lateral position or prone position.
~Selective bile duct cannulation is performed using wire-guided cannulation.
~In case of difficult cannulation, precut is performed using a needle-knife.
~After selective cannulation, cholangiogram is obtained using ERCP catheter, and endoscopic sphincterotomy and/or endoscopic papillary balloon dilation is performed."
16040270|NCT02594085|Other|Patch 3|Patch 3 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 3 contains simulated output. The Patch is placed over the adhesive strip to invesitgate the impact of output on the adhesive strip
16040220|NCT02594462|Drug|etonogestrel-releasing implant contraceptive|The etonogestrel implant will be inserted until the fifth day of the menstrual cycle . Anthropometric measurements will be performed , blood pressure measurement , application of pain questionnaire for the last three months, and collection of fasting blood in our clinic . After these measures , the ENG implant will be applied per researcher trained for such a procedure , following the recommendations outlined by the manufacturer. Women are instructed to return after 3, 6, 9, 12 months, fasting 8h , when they will be measured anthropometric measurements , blood collection, and delivery of pain questionnaires and standard of menstrual bleeding.
16040221|NCT02594449|Drug|Benzalkonium Chloride Solution|To compare pharmacodynamics among the different concentrations of BCS and NS
16040222|NCT02594436|Drug|Ingenol mebutate|Non-Interventional study enrolling patients already planned to be treated with ingenol mebutate according to approved labelling
16040223|NCT02594423|Device|Fine Needle Diathermy|Fine needle diathermy is a surgical procedure that is used in the treatment of corneal NV. It is a safe and effective method for corneal vessels occlusion.
16040224|NCT02594423|Drug|Bevacizumab|Bevacizumab is a humanized monoclonal antibody that binds to isoforms of VEGF-A .
16040225|NCT02594410|Device|stent|patients receiving renal artery stenting for renal artery atherosclerosis
16040226|NCT02594410|Drug|Aspirine|100mg Qd
16040227|NCT02594410|Drug|Clopidogrel|75mg Qd
16040228|NCT02594410|Drug|Lercanidipine|10-20mg Qd
16040229|NCT02594397|Other|acupoints combination 1|
16040230|NCT02594397|Other|acupoints combination 2|
16040231|NCT02594397|Other|sham acupoints combination|
16040232|NCT02594384|Drug|LAM-002A|25 mg capsules or 50 mg capsules
16040233|NCT02594384|Drug|Rituximab|375 mg/m2 by vein
16040234|NCT02594384|Drug|Atezolizumab|1200 mg by vein
16040235|NCT02594371|Drug|Oraxol|
16040236|NCT02594371|Drug|IV paclitaxel|
16040237|NCT02594358|Drug|Caffeine|20 MG OR 40 MG ONCE DAILY ALONG WITH PATCHING
16040238|NCT02594345|Other|in vitro study|Exosomes will be mixed with healthy volunteers' blood in vitro
16040239|NCT02594332|Drug|Mepolizumab|100 mg SC every 4 weeks for 13 injections
16040240|NCT02594332|Drug|Placebo|
16040241|NCT02594319|Behavioral|Monetary incentives|
16040242|NCT02594319|Behavioral|Self monitoring|
16040243|NCT02594306|Device|Emotional pictures stimulation system|Emotional pictures stimulation system is component of neutral and drug-related images.
16040244|NCT02594306|Procedure|Deep brain stimulation|Deep brain stimulation of bilateral NAc/ALIC
16040245|NCT02594306|Procedure|adjacent contact stimulation|The electrode of deep brain stimulation has four contacts.We stimulate one contact,and record the local field potential of other contacts.
16040246|NCT02594306|Procedure|microelectrode|We put the microelectrodes into bilateral nucleus accumbens and anterior limb of the internal capsule,to record the waveform of bilateral NAc/ALIC.
16040247|NCT02594293|Drug|PegIFN alfa-2a|180 μg/ 0.5 ml ,hypodermic injection once a week
16040248|NCT02594267|Drug|Pralatrexate Injection|"Drug: Folotyn (Pralatrexate Injection)
~CHOP : Cyclophosphamide, Doxorubicin, Vincristine, & Prednisone"
16040249|NCT02594254|Drug|C16G2 Gel|Antimicrobial peptide
16040250|NCT02594254|Other|Placebo|Placebo
16040251|NCT02594241|Drug|Methyl-Prednisolone|Single-shot 125 mg infusion given immediately after induction of anesthesia.
16040252|NCT02594241|Drug|Physiological saline|A single preoperative dosage 100 ml given intravenously as a 30 minute infusion, 2 hours before surgery
16040253|NCT02594228|Behavioral|Whey Protein and exercise training|Six meals per day four of which were whole food and two of whey protein for an overall percentage of macronutrient intake of 25% protein and 4 days per week of exercise training
16040254|NCT02594228|Behavioral|Food Protein and exercise training|Six meals per day all of which were whole food protein for an overall percentage of macronutrient intake of 25% protein and 4 days per week of exercise training
16040255|NCT02594215|Drug|MK-7075 (miransertib)|MK-7075 or miransertib (formerly ARQ 092) is small molecule that effectively inhibits AKT. Proteus syndrome is caused by mosaic activating mutations in AKT1. This is a phase I study to determine a recommended dose for subsequent trials, which will determine the efficacy of miransertib in Proteus syndrome.
16040256|NCT02594189|Other|Live recombinantly derived A/Bethesda/MM1/H3N2 virus|The human challenge virus will be administered intranasally to each participant using a nasal sprayer. A total volume of up to 2mL of virus will be administered.
16040257|NCT02594176|Device|FLEXISEQ®|applicable gel
16040258|NCT02594176|Device|Placebo|applicable gel
16040259|NCT02594163|Drug|Brentuximab Vedotin|
16040260|NCT02594163|Drug|Rituximab|
16040261|NCT02594163|Drug|Bendamustine|
16040262|NCT02594150|Other|Financial Incentive|Financial incentives provide small immediate and tangible rewards that are aligned with the abstract long-term rewards of cancer prevention.
16040263|NCT02594137|Procedure|Without watertight duraplasty|After standard craniectomy and dural opening, provided there is no brain contusions or hematomas requiring surgical evacuation, no watertight duraplasty is performed. The dura is left opened and the brain parenchyma is covered with Surgicel. Usual closure is then performed.
16040266|NCT02594098|Drug|Secukinumab|At Weeks 0, 1, 2, 3, 4 and every 2 weeks thereafter through and including Week 12 in phase 1 of the study.
16040267|NCT02594098|Drug|Placebo|At Weeks 0, 1, 2, 3, 4 and every 2 weeks thereafter through and including Week 12 in phase 1 of the study.
16040268|NCT02594085|Other|Patch 1|Patch 1 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 1 contains the subjects own feces. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip
16040269|NCT02594085|Other|Patch 2|Patch 2 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve Patch 2 contains the subjects own feces and filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip
16040448|NCT02592837|Device|21G EBUS-TBNA needle|
16040922|NCT02589600|Dietary Supplement|calcium|approximately 1200 mg (dietary and supplement)
16040271|NCT02594085|Other|Patch 4|Patch 4 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 4 contains simulated output with filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip
16040272|NCT02594085|Other|patch 5|Patch 5 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 5 contains buffer. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip
16040273|NCT02594085|Other|Patch 6|Patch 6 describes a test system which contains an adhesive strip and an adhesive patch with a sleeve. The sleeve of Patch 6 contains buffer with filler. The Patch is placed over the adhesive strip to investigate the impact of output on the adhesive strip
16040274|NCT02594072|Radiation|stereotactic ablative radiotherapy|Linac-based prostate stereotactic radiotherapy, using Volumetric Modulated Arc Therapy planning and delivery, with fiducial marker and cone-beam CT based image guidance.
16040275|NCT02594072|Radiation|external beam radiation therapy|Conventional intensity modulated radiotherapy, with fiducial marker or cone-beam CT based image guidance.
16040276|NCT02594072|Drug|Zoladex ®|The preferred agent for the protocol is goserelin acetate (Zoladex ®) 3-month depot, but other LHRH agonists are permitted. The total duration of ADT will be 6 months for men with intermediate risk disease, and 18 months for those with high risk disease. ADT is to be initiated prior to the start of RT.
16040277|NCT02594059|Other|endothelial function|measure of reactive hyperemia-peripheral artery tone index
16040278|NCT02594046|Other|stem cell component extract|The Allogeneic Human adipose derived stem cell component extract
16040279|NCT02594033|Drug|insulin aspart|All subjects make three intervention visits with at least 5 days between individual intervention visits. At each intervention visit the subject receives one insulin aspart injection with only one type of needle.
16040280|NCT02594020|Procedure|air abrasion|already used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin
16040281|NCT02594020|Procedure|sono abrasion|already used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin
16040282|NCT02594020|Procedure|dental bur|already used intervention to prepare micro cavities of the dental to be treated by a photopolymerizable resin
16040283|NCT02594007|Device|SEEQ|Mobile cardiac telemetry system worn externally for a total of 28 days.
16040284|NCT02594007|Device|Cardiocom|Patient-based interface tool that includes a blood pressure cuff and blue-tooth enabled scale for daily recordings. The patient will also answer a series of behavioral and symptomatic questions daily through 30 days.
16040285|NCT02594007|Device|DocView|Patient-based interface tool that analyzes state of wellness. The patient will answer a series of questions daily through day 30.
16040286|NCT02593994|Device|Onyx Drug Eluting Stent group|
16040287|NCT02593981|Dietary Supplement|Fruit/Honey drink|2 canisters of powder containing fruit/honey mix to be mixed with water and ingested twice a day for 28 days
16040288|NCT02593981|Dietary Supplement|Placebo|2 canisters of Placebo powder containing non-active ingredient to be mixed with water and ingested twice a day for 28 days
16040289|NCT02593968|Drug|Recombinant Human Interferon a-2b Gel|
16040290|NCT02593968|Drug|Placebo|
16040291|NCT02593955|Behavioral|PD exercise|Supervised high intensity exercise 3x/week for 16 weeks
16040292|NCT02593955|Behavioral|Sleep Hygiene|Sleep medicine physician will provide discuss sleep habits with participants, provide tips for improving sleep hygiene, and provide reading materials.
16040293|NCT02593942|Drug|Remifentanil|0.1-0.5 mcg/kg/min infusion
16040294|NCT02593942|Drug|Propofol|75-200 mcg/kg/min infusion
16040295|NCT02593929|Drug|ruxolitinib|
16040296|NCT02593903|Drug|Septra|
16040297|NCT02593890|Device|THEYA Recovery Range|Post-operative Lingerie made from viscose derived bamboo
16040298|NCT02593877|Device|VHA algorithm|Analysis of more than 2,200 trauma subjects has enabled the definition of clinically-relevant VHA thresholds (i.e. ROTEM® and TEG® parameters) and patterns by which it is possible to rapidly identify coagulopathic patients and anticipate the need for massive transfusion. These threshold parameters have been defined and applied to the generation of an evidence-based targeted treatment algorithm (i.e. the Intervention)
16040299|NCT02593864|Device|Variable-Stiffness Shoe|A load-modifying variable-stiffness shoe previously shown to reduce joint loading
16040300|NCT02593851|Drug|JNJ-53718678|JNJ-53718678 oral solution will be administered once or twice daily for 7 days.
16040301|NCT02593851|Drug|Placebo|Placebo oral solution will be administered once or twice daily for 7 days.
16040302|NCT02593838|Other|CT-MPI and SPECT-MPI|All patients undergo CT-MPI plus SPECT-MPI
16040303|NCT02593825|Behavioral|START-Play intervention|The START-Play group is a perceptual-motor approach, which uses self-initiated goal-directed movements to bolster orienting and attending to objects, while understanding basic relationships of cause and effect through manipulation and focused attention. Generally, activities focus on helping the child attend to significant environmental information, which can be correlated to forces useful for controlling posture and movement. Unlike passive movement therapy, the investigator's approach encourages activity and learning to solve problems linked by movement and manipulation of objects, which then scaffold cognitive skill.
16040304|NCT02593825|Behavioral|Business as usual|May include active or passive movement, parent training, positioning, equipment modification, training other team members, functional skill training
16040305|NCT02593812|Behavioral|Stepping training|Participants will step rapidly to one of four cued targets. Each trial will consist of 24 steps. Participants will perform 6 blocks of 6 trials per day for 3 consecutive days.
16040306|NCT02593799|Procedure|Endoscopy|Upper gastrointestinal endoscopy to evaluate the presence of any grade varices and high-risk varices.
16040307|NCT02593786|Drug|Nivolumab|
16040308|NCT02593773|Drug|Interferon γ-1b|The study drug dose is planned to be escalated on a weekly basis over the first 4 weeks of treatment (from 10 µg/m² to 25, 50, and 100 µg/m²). The dose may be reduced, interrupted, or held based on tolerability. By Week 13, all participants are to be on a stable tolerated dose of study drug in order to continue study participation; the dose may not be further increased after Week 13, however, it may be reduced on a case-by-case basis to manage drug-related adverse events (AEs).
16040309|NCT02593760|Other|Placebo|Placebo will be administered PO QD for up to 48 weeks.
16040310|NCT02593760|Drug|Ruxolitinib|Ruxolitinib will be administered PO BID at a starting dose depending on the participants's baseline platelet count for up to 48 weeks.
16040311|NCT02593760|Drug|Vismodegib|Vismodegib will be administered at a dose of 150 mg PO QD for up to 48 weeks.
16040312|NCT02593747|Drug|Loratadine oral solution|Subjects received a single oral dose of 10 mg loratadine oral solution/syrup 1 mg/mL (GPLA formula, test formulation) under fasted condition in any intervention period.
16040313|NCT02593747|Drug|Loratadine (Claritin peach syrup)|Subjects received a single oral dose of 10 mg loratadine claritin peach syrup 1 mg/mL (ANNA formula, reference formulation) under fasted condition in any intervention period.
16040314|NCT02593734|Drug|olanzapine|oral antipsychotic drug therapy
16040315|NCT02593734|Drug|risperidone|oral antipsychotic drug therapy
16040316|NCT02593734|Drug|amitryptaline|oral antidepressant drug therapy
16040317|NCT02593734|Drug|fluoxetine|oral drug therapy for depression
16040318|NCT02593721|Procedure|Median Nerve Neural Mobilization|Non-surgical non-invasive Median Nerve neural mobilization procedure was applied by a physical therapist continuously during 2 minutes in 5 different occasions with 1 minute of rest between each 2 minute application of the Neural Mobilization technique. The intervention was applied during a period of 6 weeks. The maximum level of elbow extension movement degree without the reproduction of symptoms during the application of the Median Nerve Neural mobilization treatment was determined through the baseline use of a Universal Goniometer Device.
16040319|NCT02593721|Drug|Ibuprofen|The active comparator group received an oral Ibuprofen treatment. The starting dose was of 400 mg/day and it was increased to a maximum of 1200 mg/day divided in 3 oral intakes every 8 hours depending on patient tolerance.The intervention was applied during a period of 6 weeks.
16040320|NCT02593708|Drug|Neratinib|
16040321|NCT02593708|Drug|Paclitaxel|
16040322|NCT02593708|Drug|Pertuzumab|
16040323|NCT02593708|Drug|Trastuzumab|
16040324|NCT02593695|Procedure|Deep brain stimulation|Deep brain stimulation of bilateral nucleus accumbens
16040325|NCT02593695|Other|Fluoxetine|Fluoxetine is one of selective serotonin reuptake inhibitors(SSRIs).
16040326|NCT02593682|Drug|suvorexant|
16040327|NCT02593682|Drug|placebo|
16040328|NCT02593669|Procedure|Phacomulsification lens removal cataract surgery with neutral Intraocular lens(IOL) implantation|The phacoemulsification lens removal cataract surgery is performed with neutral IOL.implantation
16040329|NCT02593669|Procedure|Phacomulsification lens removal cataract surgery with blue-blocking Intraocular lens(IOL) implantation|The phacoemulsification lens removal cataract surgery is performed with blue-blocking IOL.implantation.
16040330|NCT02593669|Drug|Subconjunctival dexamethasone and general anesthesia|All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia.
16040331|NCT02593669|Drug|Viscoelastic materials|viscoelastic materials are used to protect corneal endothelial cells.
16040332|NCT02593656|Behavioral|High Protein|Protein-pacing throughout the day and exercise training for 12 weeks
16040333|NCT02593656|Behavioral|Normal Protein|Normal protein intake throughout the day and exercise training for 12 weeks
16040334|NCT02593643|Drug|Ketamine|
16040335|NCT02593643|Drug|Midazolam|
16040336|NCT02593643|Other|Treatment as usual (TAU)|TAU includes any current treatment a patient is receiving from their primary care practitioner. In the major depressive disorder (MDD) group, TAU may include a newly initiated or longstanding antidepressant. In the bipolar depression (BD) group, TAU may include a mood stabilizer such as lithium or valproate that is a first or second line agent as per Canadian Network for Mood and Anxiety Treatments (CANMAT) guidelines (Yatham et al., 2013).
16040337|NCT02593630|Device|Unicirc circumcision|Unicirc circumcision under topical (EMLA) anaesthesia, wound sealing with cyanoacrylate tissue adhesive
16040338|NCT02593617|Other|Addiction Profile Index|
16040339|NCT02593617|Other|Alcohol Use Disorders Identification Test|
16040340|NCT02593617|Other|Barratt Impulsiveness Scale|
16040341|NCT02593617|Other|Zuckerman Sensation Seeking Scale|
16040342|NCT02593617|Other|Energy Drink Consumption Questionnaire|
16040343|NCT02593565|Other|Online questionnaires|Women will be asked to complete questionnaires during their pregnancy and a postpartum questionnaire.
16040344|NCT02593552|Device|DriveCam|Video event monitoring device
16040345|NCT02593539|Drug|Nemiralisib|Participants will be administered nemiralisib
16040346|NCT02593526|Drug|Bumetanide|Diuretic
16040347|NCT02593526|Other|Cool Dialysate|Cool dialysate (35°C)
16040348|NCT02593513|Device|Daifert|
16040349|NCT02593513|Procedure|Control Group|Control - Morphological Assessment
16040350|NCT02593500|Drug|Budesonida Pulmictan® 200 µg|
16040351|NCT02593500|Drug|Budesonide 200 µg|
16040352|NCT02593487|Drug|Rosuvastatin 10mg/d group|rosuvastatin 10mg tablet,q.d. for 12 weeks.
16040353|NCT02593487|Drug|Rosuvastatin 20mg/d group|rosuvastatin 20mg tablet,q.d. for 12 weeks.
16040354|NCT02593474|Drug|Naltrexone|Outpatient detoxification and induction onto long-acting naltrexone followed by an additional second injection of long-acting naltrexone and and additional third if desired.
16040355|NCT02593461|Device|Daifert|
16040356|NCT02593461|Other|Control Group|
16040357|NCT02593448|Procedure|NIRS during VOT|"Near infrared spectroscopy with INVOS oximeter during vascular occlusion test (VOT) on following timepoints:
~30 minutes after anaesthesia induction,
~directly after the sternotomy,
~during CPB - 20 minutes after aortic cross-clamping ,
~40 minutes after aortic cross-clamping,
~20 minutes after the release of the aortic cross-clamp,
~45 minutes after weaning of CPB."
16040358|NCT02593448|Procedure|General anaesthesia with propofol use|"Premedication: lorazepam 50 μg kg-1, omeprazole 40 mg, and metoprolol 12.5 mg one hour before transport to the operating theatre.
~Anaesthesia induction: 0.2 mg fentanyl, 0.3 mg/kg, etomidate, and vecuronium bromide 0.1 mg/kg for muscle relaxation, followed by a continuous infusion at the rate of 0.05 mg/kg/h until the sternum closure.
~Intraoperative analgesia: fentanyl in fractions, up to the total dose of 20-30 μg/kg.
~Maintenance of anaesthesia in 'Propofol' group will be accomplished using continuous intravenous infusion of propofol 2-4 mg kg/h.
~Propofol infusion rate will be adjusted according to patient's haemodynamic parameters and the level of anaesthesia, as assessed with Bispectral Index (BIS), with a target range of 40-60."
16040359|NCT02593448|Procedure|General anaesthesia with sevoflurane use|"Premedication: lorazepam 50 μg kg-1, omeprazole 40 mg, and metoprolol 12.5 mg one hour before transport to the operating theatre.
~Anaesthesia induction: 0.2 mg fentanyl, 0.3 mg/kg, etomidate, and vecuronium bromide 0.1 mg/kg for muscle relaxation, followed by a continuous infusion at the rate of 0.05 mg/kg/h until the sternum closure.
~Intraoperative analgesia: fentanyl in fractions, up to the total dose of 20-30 μg/kg.
~Sevoflurane concentration in exhaled gas will be adjusted according to patient's haemodynamic parameters and the level of anaesthesia, as assessed with BIS, with a target range of 40-60."
16040360|NCT02593435|Genetic|NGS test|"To record the characteristic QC parameters and evaluate the detection performance of Next-Generation Sequencing (NGS), including coverage depth and sequence similarity, then be used to evaluate the quality of base recognition and alignment.
~To know mutation characteristic spectrum of BRCA1/2."
16040361|NCT02593422|Behavioral|Expressive Writing|Participants will be asked to write about their deepest thoughts and emotions about their experience with ovarian cancer
16040362|NCT02593422|Behavioral|Fact Writing (Control)|Participants will be asked to write about the facts of their experience with ovarian cancer
16040363|NCT02593409|Drug|TDF/FTC|All participants receive pre-exposure prophylaxis in the form of a daily tablet containing 300 mg of tenofovir disoproxil fumarate and 200 mg emtricitabine (Truvada®, Gilead) for one year, with an optional extension for 6 months.
16040364|NCT02593396|Drug|Bupropion hydrochloride sustained-release|Up to 70 eligible patients will be randomly assigned to Bupropion Hydrochloride Sustained-Release or placebo treatment groups in a 1:1 ratio using a computer-generated table of random numbers through the use of the Randomization.com program. Subjects will be randomized to to Bupropion Hydrochloride Sustained-Release 150mg b.d. (n = 35) or placebo b.d (n = 35)The study drug will be repacked in the standard capsules by the research assistant who is not involved in the assessment of the study. The study drug and placebo will be packaged in sets of 11 (1 tablet per day for 3 days, followed by 2 tablets per day for 4 days.) for the first week. Subsequently, the study drug and placebo will be packaged in sets of 14 (2 tablets per day for 7 days.).
16040365|NCT02593396|Drug|placebo|Up to 70 eligible patients will be randomly assigned to Bupropion Hydrochloride Sustained-Release or placebo treatment groups in a 1:1 ratio using a computer-generated table of random numbers through the use of the Randomization.com program. Subjects will be randomized to to Bupropion Hydrochloride Sustained-Release 150mg b.d. (n = 35) or placebo b.d (n = 35)
16040366|NCT02593383|Drug|Adapalene + Clindamycin Hydrochloride|0.1% Adapalene + 1% Clindamycin Hydrochloride
16040367|NCT02593383|Drug|Adapalene + Clindamycin Hydrochloride|0.1% Adapalene + 2% Clindamycin Hydrochloride
16040368|NCT02593383|Drug|Adapalene + Clindamycin Hydrochloride|0.05% Adapalene + 0.5% Clindamycin Hydrochloride
16040369|NCT02593383|Drug|Adapalene + Clindamycin Hydrochloride|0.05% Adapalene + 1% Clindamycin Hydrochloride
16040370|NCT02593383|Drug|Placebo|
16040371|NCT02593370|Drug|Lidocaine-epinephrine added gadoterate meglumine|
16040372|NCT02593357|Device|COPD patients|measure of peripheral endothelial function by the reactive hyperemia-peripheral artery tone index with a specific device (EndoPAT®)
16040373|NCT02593344|Device|Endopat|measure of peripheral endothelial function by the reactive hyperemia-peripheral artery tone index with a specific device (Endopat)
16040374|NCT02593331|Drug|BFKB8488A|Participants will receive either a single escalated dose of BFKB8488A administered SC or a single dose of BFKB8488A administered IV on Day 1.
16040375|NCT02593331|Other|Placebo|Participants will receive a single dose of placebo on Day 1.
16040376|NCT02593318|Drug|Oxaloacetate (OAA) 1g|Pills to be taken orally in 500mg dose two times per day
16040377|NCT02593318|Drug|Oxaloacetate (OAA) 2g|Pills to be taken orally in 1000mg dose two times per day.
16040378|NCT02593305|Dietary Supplement|Super Beets|Nitrate rich beetroot powder (10g/day) for 4 weeks
16040379|NCT02593305|Dietary Supplement|Super Beets Placebo|Nitrate deficient beetroot powder (10g/day) for 4 weeks
16040380|NCT02593292|Behavioral|PROSPERO|"The intervention is carried out in 3 steps:
~At the start of the pregnancy: a number of process steps are defined for a patient's pathway adapted to medical, obstetric and social risk factors.
~During pregnancy: city based doctors and midwives work together with their hospital peers enabling patients to participate through the reporting via a medical information system
~The entrance in the delivery room: patients are classified as low or high risk for greater vigilance from midwives."
16040381|NCT02593292|Other|control|At the start of the pregnancy, medical, obstetric and social risk factors are checked in the same way than the PROSPERO group. An adapted patient pathway was defined by a Clinical Research Assistant but unreachable from patients, midwifes and physicians. The electronic patient care reporting information system will be disabled and midwifes cannot create the classification checklist for low or high risk delivery.
16040382|NCT02593279|Genetic|asthma with proximal airways obstruction phenotype profile description with clinical, biological, morphologic and genetic elements.|symptoms, medical history, date of start, date of aggravation, comorbidities, increased factors related to asthma, blood eosinophils, blood periostin, allergologic patch test, igE analysis, tomodensitometric test.
16040383|NCT02593279|Genetic|asthma with small airways dysfunction phenotype profile description with clinical, biological, morphologic and genetic elements.|symptoms, medical history, date of start, date of aggravation, comorbidities, increased factors related to asthma, blood eosinophils, blood periostin, allergologic patch test, IgE analysis, tomodensitometric test.
16040384|NCT02593266|Behavioral|Preventive Intervention Program (PIP) for depression|"Manualized intervention designed by Beardslee and colleagues (Beardslee et al., 2003) It is a program based on cognitive behavioural therapy, narrative therapy and systemic therapy. It is divided in 7 modules which are imparted weekly in the family home by 2 'preventionists' (therapists trained to deliver the intervention)
~Module 1: Depression and family
~Module 2: Psychoeducation about depression
~Module 3:The child's perspective on their parent's depression
~Module 4: Skills development
~Module 5: Preparation for the family session
~Module 6: Family session
~Module 7: Revision and future planning
~Follow-up"
16040385|NCT02593253|Other|Audit and Feedback Bundle|The intervention arm teams will receive the new audit and feedback bundle, which includes access to the electronic dashboard and weekly feedback rounds in which they review their performance on several inpatient quality metrics via the dashboard.
16040561|NCT02592200|Dietary Supplement|Placebo|Two doses per day for 28 days
16040562|NCT02592187|Behavioral|ReMemory-MCI training|
16040386|NCT02593253|Other|Bi-weekly audit and feedback emails|The control arm will undergo audit and feedback per the current system, which is biweekly feedback emails with performance on selected quality measures.
16040387|NCT02593240|Behavioral|The iDiet® (also called Healthy Weight for Living when used as a not-for-profit intervention) with Food|The intensive iDiet® group behavioral weight loss program will be delivered in person at the worksite or by videoconference and with support of the program's web platform. This intervention will be delivered by trained group leaders and will initially include weekly 1-hour support and education meetings of 20 participants/group with a message board for group communication and individual communication with the group leader. Over time support will be provided online rather than in live meetings. The intervention involves a weight loss behavioral program with particular emphasis on hunger reduction and craving control for both weight loss and prevention of weight regain. Half of the participants per worksite receiving the iDiet® intervention will be randomized to receive commercial dried food products (partial supply) from Yevo Intl., which are designed to help with weight control and health.
16040388|NCT02593240|Behavioral|The iDiet® (also called Healthy Weight for Living when used as a not-for-profit intervention) with Voucher|The intensive iDiet® group behavioral weight loss program delivered in person at the worksite or by videoconference and with support of the program's web platform. This intervention will be delivered by trained group leaders and will initially include weekly 1-hour support and education meetings of 20 participants/group with a message board for group communication and individual communication with the group leader. Over time support will be provided online rather than in live meetings. The intervention involves a weight loss behavioral program with particular emphasis on hunger reduction and craving control for both weight loss and prevention of weight regain. Half of the participants per worksite receiving the Diet® intervention will be randomized to receive gift cards monthly for the first 6 months to purchase foods at their local grocery store (partial costs).
16040389|NCT02593240|Behavioral|Human Performance Institute©|The Human Performance Institute© (HPI) training workshop is a comprehensive individual development training program that focuses on the concept of energy management. The primary aim of this program is to help individuals develop attitudes, habits, and behaviors that increase their levels of daily energy, life satisfaction, and overall functioning. The course is delivered at an off-site location over 2.5 days, by 3 coaches, in a group format of 25 - 32 participants (with employees from more than one worksite per group).
16040390|NCT02593227|Biological|Low dose FRα vaccine|165ug per peptide ID injection
16040391|NCT02593227|Drug|Cyclophosphamide|IV infusion over 1 hour
16040392|NCT02593227|Biological|High dose FRα vaccine|500ug per peptide ID injection
16040393|NCT02593214|Device|Wondaleaf®|Use of Wondaleaf® during sexual intercourse with husband for 5 times in a month period
16040394|NCT02593201|Drug|Extended antibiotics (cefazolin or ceftazidime)|To continue with the existing effective antibiotic therapy for one extra week
16040395|NCT02593201|Drug|Usual antibiotics (cefazolin or ceftazidime)|Usual duration of effective antibiotic therapy therapy
16040396|NCT02593188|Biological|HYQVIA|Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase
16040397|NCT02593175|Drug|Carboplatin|Given IV
16040398|NCT02593175|Drug|Paclitaxel|Given IV
16040399|NCT02593175|Biological|Panitumumab|Given IV
16040400|NCT02593162|Drug|Faldaprevir|
16040401|NCT02593162|Drug|TD-6450|
16040402|NCT02593162|Drug|Ribavirin|
16040403|NCT02593149|Device|ClearGuard HD End Cap|The ClearGuard HD end cap elutes chlorhexidine acetate into the hemodialysis hub
16040404|NCT02593136|Dietary Supplement|Home Fortification Product (HFP)|"The home fortification product (HFP) is a sachet containing multiple vitamins and nutrients as follows:
~Iron (Ferrous Fumarate) 12.5 mg Zinc (Zinc Gluconate) 5 mg Folic Acid 0.160 mg Vitamin-A (Vit-A Acetate) 0.30 mg Vitamin-C (Ascorbic Acid) 30 mg Vitamin-B12 0.9 mcg Iodine 90 mcg Maltodextrin (Base)"
16040405|NCT02593136|Other|Infant and Young Child Feeding (IYCF) Practices Counseling|Infant and Young Child Feeding (IYCF) Practices Counseling provides direction on breast milk and milk feeding, food variety, and frequency for caregivers of children aged 6 to 18 months. Participants will be visited at least monthly by a field line worker for IYCF counseling and educational materials distribution.
16040409|NCT02593110|Behavioral|Supervised Treadmill Exercise Therapy|Participants randomized to the exercise intervention will receive supervised treadmill exercise three times weekly for six months.
16040410|NCT02593110|Drug|Telmisartan|Participants randomized to the telmisartan arm of the study will take 20 mg or 40 mg of telmisartan daily based on the results of their study run-in. Participants will have their dose increased to up to 80 mg as tolerated.
16040411|NCT02593110|Other|"No exercise control group"|Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months.
16040412|NCT02593110|Drug|Placebo|
16040413|NCT02593097|Drug|Metformin|Metformin 500mg twice daily
16040414|NCT02593097|Drug|Matching Placebo|Matching Placebo twice daily
16040415|NCT02593084|Behavioral|Higher Intensity Resistance Training|Bi-weekly resistance training for 12 weeks using multi-joint movements involving both upper and lower extremities (e.g squats). Participants will perform 3-5 sets of 3-6 repetitions at Rating of Perceived Exertion 8/10. The intervention will be administered by a Physical Therapist or trained fitness professional.
16040563|NCT02592187|Behavioral|Control intervention|
16040649|NCT02591563|Other|procedures|Nasopharyngeal swab, nasopharyngeal wash, tympanocentesis (if acute otitis media occurs), venipuncture
16040416|NCT02593084|Behavioral|Lower Intensity Resistance Training|Bi-weekly resistance training for 12 weeks using single-joint movements involving both upper and lower extremities (e.g leg extension). Participants will perform 3-5 sets of 8-10 repetitions at Rating of Perceived Exertion 5/10. The intervention will be administered by a Physical Therapist or trained fitness professional.
16040417|NCT02593071|Biological|RSV-F Vaccine|
16040418|NCT02593071|Biological|Phosphate Buffer Placebo|
16040419|NCT02593058|Behavioral|Positive Emotions Program for Schizophrenia|Each session of PEPS includes relaxation-meditation exercise, review of homework task given during the previous session, exercises to challenge defeatist beliefs. According to the session's theme, participants learn skills to improve their anticipation or maintenance of pleasure such as savoring a pleasant experience, expressing emotions by increasing behavioral expression, capitalizing on positive moments, and anticipating pleasant moments. A simple homework task is assigned to be done between each session. The pedagogical concept underpinning the program was built according to Kolb and Kolb's model of experiential learning. The program uses a collaborative, egalitarian approach.
16040420|NCT02593058|Behavioral|Treatment As Usual|TAU consists of psychiatric management by a clinical team composed of at least one psychiatrist and a social worker and/or a psychiatric nurse with additional access to community treatment or hospital admission. Treatment involves antipsychotic medication, regular office-based or community contact with the clinical team for treatment monitoring, and socialization groups, therapy, and psychoeducational groups. No attempts have been made to standardize this treatment as TAU is tailored to the patient's specific needs.
16040421|NCT02593045|Biological|IPH4102|
16040422|NCT02593032|Device|Pre-filled trays|Randomized Control Trial Patients in the research treatment group receive pre-filled, 3x7 disposable trays that separate their medication by dose and time (e.g. morning, afternoon, evening). These pre-filled trays are inserted into a connected, weekly pillbox that detects when pills are removed from its wells.
16040423|NCT02593019|Drug|AZD1775|"AZD1775 175 mg BID per os every 12 hours (6 doses) administered days 1-3 the first week and then days 1-3 the 2nd week of 21 day cycle.
~Tumour evaluation using RECIST 1.1 will be conducted at screening (within 28 days prior to first dose) and every 6 weeks relative to the date of first dose, up to week 42, then every 9 weeks until objective disease progression (within a window of +/- 7 days of the scheduled date)."
16040424|NCT02592993|Device|PicoWay device|The PicoWay base unit using a single, free-running, flashlamp-pumped alexandrite laser as a pump source for both the oscillator and the amplifier.
16040425|NCT02592980|Genetic|Pharmacogenetic anticoagulation|The investigators use a algorithm pharmacogenetic for adjust only the first dose in the study.
16040426|NCT02592980|Drug|Traditional anticoagulation|The physician will adjust the dose according to current INR value based on guidelines.
16040427|NCT02592967|Biological|JNJ-64041757 (Cohort 1A and 1B)|JNJ-64041757 will be administered IV at a lower dose in Cohort 1A (1x10^8 colony forming units [CFU] ) and at a higher dose in Cohort 1B (1x10^9 CFU)
16040428|NCT02592967|Biological|JNJ-64041757 (Cohort 2A and 2B)|JNJ-64041757 will be administered intravenously (IV) once every 21 days at the recommended dose as determined in Cohort 1A or 1B.
16040429|NCT02592954|Drug|Jojoba oil with broccoli sprout extract|500nmol of broccoli sprout extract in 1ml of jojoba oil will be applied to the same arm every night under saran wrap for 1 week
16040430|NCT02592954|Drug|Jojoba oil (placebo)|1ml of jojoba oil will be applied to the same arm every night under saran wrap for 1 week
16040431|NCT02592941|Drug|Deflazacort|Deflazacort, a glucocorticoid with anti-inflammatory and immunosuppressive effects, is used in treating a variety of diseases. Pharmacologically it is an inactive pro-drug which is metabolized immediately to the active metabolite, 21 desacetyl-DFZ. The elimination of this metabolite is primarily via the urine in humans. Its potency is approximately 70 to 90% of prednisone and 6 mg of deflazacort has approximately the same anti-inflammatory potency as 5 mg of prednisolone or prednisone.
16040432|NCT02592928|Other|Inclusion of Spirometry into the Electronic Health Records|Inclusion of the Forced Spirometry into the Electronic Health Records
16040433|NCT02592915|Drug|Clonidine hydrochloride|Single bolus of clonidine hydrochloride 0.3µg/kg (max 150 µg/kg) administered IV after induction and obtaining a stable anaesthetic level
16040434|NCT02592915|Other|Single bolus of physiologic sodium chloride serum administered IV after induction and obtaining a stable anaesthetic level|
16040435|NCT02592902|Procedure|Surgical collection of histology specimen|Collection of a histology specimen from the vocal cords and rear laryngeal commissure
16040436|NCT02592902|Procedure|Performance of immunohistochemical analysis|Immunohistochemical analysis - presence of pepsin, HPV 6 and 11, HSV 2 and chlamydia trachomasis
16040437|NCT02592889|Device|MITRACLIP|MITRAL VALVE REPAIR WITH THE MITRACLIP SYSTEM
16040438|NCT02592876|Drug|denintuzumab mafodotin|Denintuzumab mafodotin 3 mg/kg by intravenous (IV) infusion, every 3 weeks for up to 3 cycles.
16040439|NCT02592876|Drug|rituximab|375 mg/m^2 by IV infusion, every 3 weeks for up to 3 cycles
16040440|NCT02592876|Drug|ifosfamide|5000 mg/m^2 by IV infusion over a 24-hour period, every 3 weeks for up to 3 cycles
16040441|NCT02592876|Drug|carboplatin|AUC 5mg/mL x min by IV infusion, every 3 weeks for up to 3 cycles
16040442|NCT02592876|Drug|etoposide|100 mg/m^2 per day by IV infusion for 3 days, every 3 weeks for up to 3 cycles
16040443|NCT02592863|Drug|Pentoxifylline|Patients will take Trental (Pentoxifylline) 3 times per day for 12 weeks
16040444|NCT02592863|Drug|Placebo|Patients will take placebo 3 times per day for 12 weeks
16040445|NCT02592850|Other|osteopathic manipulative treatment|"This intervention will not be protocol-based but the treating D.O. will compulsory have to include the evaluation (and possible treatment) of temporo-mandibular joint disorders and cervical dysfunctions (semi-structured treatment). Specifically, OMT will focus on correcting those osteopathic dysfunctions found during the initial evaluation; both structural (including myofascial release and HVLA), visceral and craniosacral techniques will be administered as appropriate.
~Duration: 45 minutes. Administered once a week for four weeks."
16040446|NCT02592850|Other|sham|"In this intervention, the operator will be restricted to the assessment of the cranial rhythmic impulse (CRI), temporo-mandibular joint disorders and cervical dysfunctions, spending a similar amount of time to that being spent on OMT-treated patients. Any found osteopathic dysfunction will not be corrected.
~Duration: 45 minutes. Administered once a week for four weeks."
16040447|NCT02592837|Device|Flexible 19G EBUS-TBNA needle|
16040449|NCT02592824|Drug|glutamate infusion|Intravenous infusion of 0.125M L-glutamic acid solution at a rate of 1.65 ml/kg BW and hour commencing at or up to 20 minutes before the release of aortic cross-clamp. The infusion is continued for two hours after declamping the aorta after which an additional 50 ml is given at a halved infusion rate.
16040450|NCT02592824|Drug|saline infusion|Intravenous infusion of saline at a rate of 1.65 ml/kg BW and hour commencing at or up to 20 minutes before the release of aortic cross-clamp. The infusion is continued for two hours after declamping the aorta after which an additional 50 ml is given at a halved infusion rate.
16040451|NCT02592811|Procedure|ERCP|Common bile duct cannulation with a cannulation catheter
16040452|NCT02592811|Procedure|Endoscopic Sphincterotomy|Endoscopic large sphincterotomy
16040453|NCT02592811|Device|Large Balloon Dilatation of Oddi Sphincter|Large Balloon Dilatation : with the HERCULES, Cook 12, 15, 18 or 20 mm of diameter (adapted to stone diameter)
16040454|NCT02592811|Procedure|Stone extraction|After dilatation, extraction of stones is done with dormia basket or extraction balloon and if not possible a mechanical lithotripsy is performed
16040455|NCT02592798|Drug|Abatacept|Abatacept IV administered on Day 1, 15, 29 and then every 28 days
16040456|NCT02592798|Other|Normal Saline|Normal Saline administer on Day 1, 15, 29 and then every 28 days
16040457|NCT02592798|Other|D5W|Dextrose 5% in Water (D5W) administered on Day 1, 15, 29 and then every 28 days
16040458|NCT02592785|Drug|BAY1163877|"Cohort 1: Single dose 600 mg on day 1, no drug on day 2 and then twice daily administration of the same dose for the remaining 19 days of cycle 1. From cycle 2 onwards all subjects are continuously treated for 21 days per cycle with twice daily administration of the same dose.
~Cohort 2: Single dose 800 mg on day 1, no drug on day 2 and then twice daily administration of the same dose for the remaining 19 days of cycle 1. From cycle 2 onwards all subjects are continuously treated for 21 days per cycle with twice daily administration of the same dose."
16040459|NCT02592772|Other|Reduced Nicotine Non-Menthol (RNC)|Switch from own brand of cigarette to an investigational tobacco product with a reduced nicotine content of 0.07mg nicotine yield without menthol.
16040460|NCT02592772|Other|Reduced Nicotine Menthol (RNC-Men)|Switch from own brand of cigarette to an investigational tobacco product with a reduced nicotine content of 0.07mg nicotine yield with menthol.
16040461|NCT02592772|Other|Conventional Nicotine Non-Menthol (CN)|Switch from own brand of cigarette to an investigational tobacco product which contains conventional nicotine yield.
16040462|NCT02592759|Device|Smart Glove Treatment|Smart glove is digital motion-based treatment device for stroke rehabilitation. The stroke patients wear this glove and hand motion is displayed on the computer monitor. They play games with this glove and are motivated to rehabilitation treatment because of fun.
16040463|NCT02592746|Drug|Palbociclib|Palbociclib 125mg, orally once daily on D1 to D21 followed by 7days off
16040464|NCT02592746|Drug|Exemestane|Exemestane 25mg, orally once daily
16040465|NCT02592746|Drug|Leuprolide Acetate|Leuprolide Acetate 3.75mg SC q 4weeks
16040466|NCT02592746|Drug|Capecitabine|Capecitabine 1,250mg/m2 bid orally form day1 to day 14 q 3weeks
16040467|NCT02592733|Device|CYDAR|CYDAR is an automated image mask that is cloud based adn delivered to operating theatres over a secure network. It fuses preoperative images with intraoperative images to provide more accurate image guidance for the surgeon.
16040468|NCT02592720|Drug|cocktail|Intracoronary cocktail injection before fractional flow reserve (FFR) measurement. Percutaneous Coronary Intervention (PCI) strategy is decided by FFR value in patients with acute coronary syndrome (ACS).
16040469|NCT02592720|Device|FFR|Percutaneous Coronary Intervention (PCI) strategy is decided by FFR value in patients with acute coronary syndrome (ACS).
16040470|NCT02592720|Device|QCA guided group|Percutaneous Coronary Intervention (PCI) strategy is decided by QCA value in patients with acute coronary syndrome (ACS).
16040471|NCT02592707|Drug|Satoreotide tetraxetan|Satoreotide tetraxetan will be administered in 3 cycles at intervals of 8 weeks (+ up to 2 additional optional cycles)
16040472|NCT02592707|Other|Amino acid solution|"Given as an auxiliary product the day of the IMP infusion for safety reasons to protect the renal function.
~Centres can use their established amino acid infusion or Ipsen amino acid solution (auxiliary medical product OPS301)"
16040473|NCT02592707|Other|Antiemetic|To counteract the known side effects of the amino acid infusion, such as nausea, dexamethasone (antiemetic) and as-required ondansetron will be administered 15 to 30 minutes before the start of the amino acid infusion (unless there are contraindications for these drugs).
16040474|NCT02592694|Drug|cocktail|Cocktail (tirofiban, bivalirudin, tenecteplase) will be given in addition to thrombus aspiration
16040475|NCT02592694|Device|thrombus aspiration|manual thrombus aspiration
16040476|NCT02592681|Procedure|verum acupuncture|"Participants will receive real needle insertion. Sterile needles will be used on all acupoints. The depth of insertion will vary from 15 mm to 20 mm depending on the exact locations. An initial manual stimulation will be given at insertion by rotation methods to produce a specific sensation described as de-qi in TCM. Then the needles will be left in the acupoint for 20 min, with a manual rotation at 4-8 Hz and an amplitude of approximately 0.5-2 rotations at a ten-min interval to maintain the sensation of de-qi. Primary acupoints used in the verum acupuncture group will be: LR3 (Taichong), LI4 (Hegu), SP6 (Sanyinjiao), GB20 (Fengchi). Extra acupoints will be selected based on TCM pattern are GB41 (Zulinqi), SP10 (Xuehai), KI3 (Taixi), or LR2 (Xingjian)."
16040477|NCT02592681|Procedure|acupressure|"The acupoints and the number of the sessions will be exactly the same as for the verum acupuncture group. Acupressure will be applied on all the corresponding acupoints described in the acupuncture group. Finger pressure will be applied to each acupoint for eight seconds followed by two-seconds rest, repeated for 3 min. The strength of the pressure depends on individual participant's sensation of de-qi. Duration of each session will be 15 min."
16040478|NCT02592681|Procedure|control acupuncture|The number, duration, and frequency of the sessions will be the same as for the verum acupuncture group. Sterile needles will be used on acupoints that have no therapeutic effect on either menstruation or migraines, based on the acupuncture text books and acupuncture research literature. The points chosen will be: LR7 (Xiguan), GB35 (Yangjiao), LI12 (Zhouliao), M-BW-1 (Dingchuan). The depth of needle insertion will be as superficial as 3 mm, and without manual rotation, in order to minimize stimulation of the needle.
16040564|NCT02592174|Other|Health related quality of life and social and demographic informations|At the inclusion visit with a self-assessment questionnaire
16040479|NCT02592668|Device|Epidural Stimulator|Subjects will be implanted with an epidural stimulator onto the dorsal aspect of the lumbosacral spinal cord dura mater. Patients will undergo a structured program of daily physical rehabilitation, treadmill step training, and epidural stimulation to recover motor, sensory, and autonomic function.
16040480|NCT02592655|Device|Pneumatic Tourniquet|Automated pneumatic tourniquet, applied to middle upper thigh.
16040481|NCT02592655|Device|One Windlass Tourniquet|One Windlass Tourniquet 3.8 cm (1.5 inch) wide. A Special Operations Forces Tactical Tourniquet Wide (SOFTT-W) will be used for the windlass tourniquet. One windlass tourniquet will be applied to the middle upper thigh.
16040482|NCT02592655|Device|Two Windlass Tourniquets|Two Windlass Tourniquets will be applied by applying a second 3.8 cm (1.5 inch) wide windlass tourniquet immediately proximal to the first windlass tourniquet.
16040483|NCT02592655|Device|Tourniquet Tape 5 cm|Tourniquet Tape is 5 cm (2 inch) in width. Tourniquet Tape is a highly elastic transparent occlusive material that can create circumferential pressure when stretched and wrapped around a limb. The tape should be stretched and overlapped by at least half the width as it is applied. The final wrap should be applied without tension.
16040484|NCT02592655|Device|Tourniquet Tape 10 cm|Tourniquet Tape is 10 cm (4 inch) in width. Tourniquet Tape is a highly elastic transparent occlusive material that can create circumferential pressure when stretched and wrapped around a limb. The tape should be stretched and overlapped by at least half the width as it is applied. The final wrap should be applied without tension.
16040485|NCT02592642|Behavioral|Self-management Program, Workbook, Video, Pedometer|Participants will attend 12 sessions over a six week period. The following therapies will be provided by licensed chiropractors: instruction on self-management strategies, cognitive behavioural techniques; exercise instruction, manual therapy. An instructional workbook and video will provide education and instruction on how to perform exercises, and reinforce instructions received during the sessions. An exercise diary will outline the frequency and intensity of the exercises. All exercises will be performed twice per day at home with the number, intensity, and frequency increasing weekly. Participants will receive a pedometer and record the maximum number of continuous walking steps and time (minutes) to stop walking due to neurogenic symptoms weekly.
16040486|NCT02592642|Behavioral|Instructional Workbook, Video, and Pedometer|Participants will attend one session with a chiropractor at the beginning of the six week treatment period. The chiropractor will provide and explain the instructional workbook and video. The workbook and video will provide education and instruction on how to perform exercises all aimed at improving overall fitness in the back and lower extremity and facilitate lumbar flexion. An exercise diary will outline the frequency and intensity of the exercises. All exercises will be performed twice per day at home with the number, intensity, and frequency increasing weekly. Participants will receive a pedometer and record the maximum number of continuous walking steps and time (minutes) to stop walking due to neurogenic symptoms weekly.
16040487|NCT02592642|Device|Para-spinal TENS|Participants randomized to this subgroup will have disposable self-adhesive electrical pads (Blue Sensor P, Ambu A/S, Denmark) applied over the para-spinal musculature from L3 to S1 by a licensed chiropractor. The electrical pad electrodes will be connected to a TENS machine (NeuroTrac TENS from Verity Medical Ltd U.K.) which will be worn by the subject concealed within a waist pouch. The TENS will be programmed for a frequency of 65-100 Hz modulated over 3-second intervals with a pulse width of 100-200 usec, and turned on 2 minutes before the start and during the SPWT. Current intensity will be set to the level of comfort of the patient, approximately 3 milliamps in pilot experiments, and below the level causing muscle twitch.
16040488|NCT02592642|Device|Para-spinal Placebo TENS|Group b: Participants randomized to this subgroup will have disposable self-adhesive electrical pads (Blue Sensor P, Ambu A/S, Denmark) applied over the para-spinal muscular from L3 to S1 by a licensed chiropractor. The electrical pad electrodes will be connected to a TENS machine [NeuroTrac TENS from Verity Medical Ltd (U.K.)] which will be worn by the subject concealed within a waist pouch. The TENS will be programmed using a transient placebo frequency and intensity (45) i.e. the unit will be active for the first 30 seconds then ramping down to zero stimulus over 15 seconds and worn from 2 minutes before the start and during the Self-Paced Walk Test (SPWT).
16040489|NCT02592642|Device|Prototype Spinal Stenosis Belt|Participants randomized to this subgroup will be fitted with the prototype spinal stenosis belt by a licensed chiropractor. The belt is designed as garment that will snugly fit over the sacrum and pelvic girdle with a pump that place pressure over the sacrum aimed at reducing lordosis.
16040490|NCT02592642|Device|Sham Spinal Stenosis Belt|Participants randomized to this subgroup will have a standard lumbar support belt (Tensor Adjustable Back Brace from 3M, 207744) fitted around the lumbar spine above the iliac crest comfortably according the manufacturer's instructions for wear. We speculate that the placement of the stenosis belt around the lumbar spine should not have any impact on the lumbar lordosis.
16040491|NCT02592629|Drug|lidocaine|used with Kenalog in shoulder injection and as topical anesthetic as subcutaneous injection
16040492|NCT02592629|Drug|ethyl chloride|topical spray
16040493|NCT02592629|Drug|Kenalog|used with lidocaine in shoulder injection
16040494|NCT02592616|Behavioral|CON|No exercise intervention.
16040495|NCT02592616|Behavioral|CW|One hour of continuous walking on a treadmill.
16040496|NCT02592616|Behavioral|IW|One hour of interval (repeated cycles of 3 minutes of fast and 3 minutes of slow) walking on treadmill.
16040497|NCT02592603|Device|Endocuff-assisted Colonoscopy|Colonic examination with Endocuff-assisted Colonoscopy
16040498|NCT02592590|Behavioral|Group A|"This condition receives three study components:
~The base-level of the smartphone app, which contains health-related educational content (i.e., weekly videos, additional resources, quiz questions), activity tracking, and graphical feedback.
~The guided goal-setting module within the app that utilizes participant activity preferences and experiences, as well as performance within the program to guide the setting of high-quality short and long-term physical activity goals. These goals form the basis of the physical activity prescription.
~The points-based feedback module. For each action in the app (e.g., setting goals, achieving goals, viewing weekly videos, answering quiz questions, tracking activity), a number of program points is awarded. These are weighted by task difficulty, and accumulate to earn levels. Levels accumulate to earn badges depicting an avatar becoming increasingly healthy and active. Badges accumulate to earn titles (e.g., expert exerciser)."
16040565|NCT02592174|Other|Neurocognitive assessment|At the neurocognitive visit, with standard test as CONSTANCES cohort
16040566|NCT02592174|Radiation|cerebral images sub-study|Standard magnetic resonance imaging
16040499|NCT02592590|Behavioral|Group B|"This condition receives two study components:
~The first is the base-level of the smartphone app, which contains health-related educational content (i.e., weekly videos, additional resources, brief quiz questions), behavioral tracking, and instantaneous graphical feedback.
~The second is the guided goal-setting module within the app that utilizes participant activity preferences and experiences, as well as performance within the program to guide the setting of high-quality short and long-term physical activity goals. These goals form the basis of the physical activity prescription."
16040500|NCT02592590|Behavioral|Group C|"This condition receives two study components:
~The first is the base-level of the smartphone app, which contains health-related educational content (i.e., weekly videos, additional resources, brief quiz questions), behavioral tracking, and instantaneous graphical feedback.
~The second is the points-based feedback module. For each action in the app (e.g., viewing weekly videos, answering quiz questions, tracking activity), a number of program points is awarded. These are weighted by task difficulty, and accumulate to earn levels. Levels accumulate to earn badges depicting an avatar becoming increasingly healthy and active. Badges accumulate to earn titles (e.g., expert exerciser). As the intervention is goal drive, these participants will also receive printed goal setting worksheets."
16040501|NCT02592590|Behavioral|Group D|This condition receives only the base-level smartphone app. This contains health-related educational content (i.e., weekly videos, additional resources, brief quiz questions), behavioral tracking, and instantaneous graphical feedback. As the intervention is goal drive, these participants will also receive printed goal setting worksheets.
16040502|NCT02592577|Biological|Autologous Genetically modified T cells, MAGEA10ᶜ⁷⁹⁶T|
16040503|NCT02592564|Behavioral|Internet-delivered cognitive behavior therapy|Internet-delivered cognitive behavior therapy for social anxiety disorder. Similar to previous studies in our research group, the treatment will be delivered during 9 weeks. Each week the participant will be introduced to a module containing text material and homework assignments. The participants will receive feedback via text by a clinical psychologist once a week.
16040504|NCT02592551|Drug|MEDI4736|MEDI4736 is formulated at 50 mg/mL in 26 mM histidine/histidine-HCl, 275 mM trehalose dihydrate, 0.02% (w/v) polysorbate 80, pH 6.0.
16040505|NCT02592551|Drug|Tremelimumab|Tremelimumab Drug Product is formulated at a nominal concentration of 20 mg/mL in 20 mM histidine/histidine hydrochloride, 222 mM trehalose dihydrate, 0.02% (weight/volume [w/v]) polysorbate 80, 0.27 mM disodium edetate dihydrate (EDTA), pH 5.5.
16040506|NCT02592551|Other|no other name|Neither MEDI4736 nor Tremelimumab will be used.
16040507|NCT02592538|Device|radiofrequency ablation|All patients underwent biliary sphincterotomy. Cholangiogram was performed to confirm stricture location, length and diameter. The Habib Endo HPB (Hepatobiliary) probe (EMcision, HitchinHerts, UK) was then advanced over a wire at the level of the biliary stricture and ablation using ERBE generator set at 7-10 watts for a time period of 90-120 s was conducted. A 1- to 2-min resting period after energy delivery was allowed before moving the catheter along the length of the stricture to ablate the rest of the stricture.
16040508|NCT02592538|Drug|S-1|In the RFA plus S-1 group, treatment with S-1 began within 1 month after RFA. Based on the patient's body surface area, S-1 was administered as follows: when the level of total bilirubin was less than 2 mg/dl. Based on the body surface area, S-1 was administered if <1.25 m2, 80 mg/day; if 1.25-1.5 m2, 100 mg/day; if≥1.5 m2, 120 mg/day. S-1 was administered orally twice daily for 14 days, followed by 7 days without treatment.
16040509|NCT02592538|Device|Stent|Plastic stent(s) were placed after RFA depending on the location of the malignant obstruction
16040510|NCT02592525|Behavioral|IP-SDM training for health professionals|Multifaceted SDM training program for providers: i) 1.5-hour online tutorial, ii) 3.5-hour skills building workshop; iii) video-clip demonstrating SDM in the context of an IP home care team with an aging adult making a decision about location of care (to be used with clients and providers as well); and iv) performance feedback to providers (role play during the workshop).
16040511|NCT02592512|Other|NIV-NAVA|Cross-over study where participants are randomized to start with either NIV-NAVA or NIV-PS/PC for 4 hours, followed by another 4 hours with the other arm.
16040512|NCT02592512|Other|NIV-PS/PC|Cross-over study where participants are randomized to start with either NIV-NAVA or NIV-PS/PC for 4 hours, followed by another 4 hours with the other arm.
16040513|NCT02592499|Device|HM III|
16040514|NCT02592499|Other|OMM, optimal medical management|Patients randomized to OMM will be treated according to international guidelines. All patients should receive a beta blocker, an ACE-inhibitor or an Angiotension II receptor blocker, and a mineralocorticoid receptor antagonist if tolerated and at optimally titrated doses according to guidelines. Loop diuretics should also be used as needed to control fluid retention. Other drugs that may relieve symptoms and improve prognosis can be used (incl ivabradin, digoxin, hydralazine,isosorbiddinitrate, anticoagulant agents). Patients that have an indication for implantable cardioverter defibrillator (ICD) and/or cardiac resynchronization therapy (CRT) should receive such therapy. Surgical interventions that may be indicated for specific underlying or contributing causes of heart failure.
16040515|NCT02592486|Biological|Simultaneous administration of Pneumovax NP® and Fluvic HA syringe®|Injections of pneumococcal vaccine and influenza vaccine simultaneously.
16040516|NCT02592486|Biological|Sequential administration of Pneumovax NP® and Fluvic HA syringe®|Injections of pneumococcal vaccine 2 weeks after the injection of the influenza vaccine.
16040517|NCT02592473|Device|Embozene Microspheres|Minimally invasive intra-arterial administration of particle embolics into prostate arteries under fluoroscopy and cone-beam CT imaging guidance.
16040518|NCT02592460|Other|poor-polyamines diet|Patients in this will receive a poor-polyamines diet during a week before and a week after foot surgery
16040519|NCT02592460|Other|high polyamines diet|Patients in this will receive a high-polyamines diet during a week before and a week after foot surgery
16040520|NCT02592447|Other|Therapy for Targeted Therapy-related Fatigue (TTF)|Cognitive Behavior Therapy for Targeted Therapy-related Fatigue (CBT-TTF) group will receive cognitive behavior therapy to help manage fatigue via FaceTime on an iPad, which will be provided to participants. Participants will meet with a trained therapist who will outline their therapy plan and will be taught how to use the iPad for upcoming therapy sessions. The sessions will initially be held weekly, but the therapist may schedule sessions at 1-, 2-, or 3-week intervals during the 18 week study period. The final session will be conducted either in-person at Moffitt or via FaceTime.
16040616|NCT02591784|Drug|Nimotuzumab|the nimotuzumab treatment; 200mg/w,weekly,5-6 weeks.
16040521|NCT02592447|Other|Wait-List Control Condition (WLC)|Participants randomized to Wait-List Control Condition will continue to receive care under direction of their Moffitt Cancer Center (MCC) physician. Physicians will be informed by email of patients' participation on the basis of elevated fatigue and their randomization to WLC. Chart review and a patient self-report form will be used at baseline and follow-up assessments to determine what, if any, services or interventions participants received in the preceding 18 weeks that might address fatigue.
16040522|NCT02592434|Drug|CP-690,550 (tofacitinib)|"During the open label run in phase, all subjects will receive active tofacitinib oral tablets or oral solution twice daily (BID) orally, at a dosage based on the subject's body weight as specified below.
~During the double blind, placebo controlled phase, subjects will receive either active tofacitinib oral tablets/oral solution or matching placebo oral tablets/oral solution, twice daily (BID), at a dosage specified below.
~Body Weight (Dosage in tablet [BID] or solution [BID]):
~5<7kg (2mg or 2mL); 7<10kg(2.5mg or 2. mL); 10 <15kg (3mg or 3mL); 15<25kg (3.5mg or 3.5mL); 25<40kg (4mg or 4mL); 40kg (5 mg or 5 ml).
~Oral solution (1 mg/mL) is used for subjects <40 kg. Oral tablets (5 mg) are used for subjects >=40 kg."
16040523|NCT02592434|Other|placebo|matching placebo tablet or solution for tofacitinib
16040524|NCT02592421|Drug|Dapagliflozin|SGLT2 inhibitor (dapagliflozin)
16040525|NCT02592421|Drug|Placebo|Placebo Comparator
16040526|NCT02592408|Drug|ASP|3 days of artesunate sulfadoxine/pyrimethamine on days 0-2
16040527|NCT02592408|Drug|SDPQ|single dose primaquine on day 2
16040528|NCT02592408|Drug|14DPQ|14 day primaquine starting on day 2
16040529|NCT02592408|Drug|14DPQ on Day 42|14 day primaquine starting on day 42
16040530|NCT02592395|Drug|FOLFIRINOX|"The chemotherapy schedule will include administration of FOLFIRINOX (5-Fluorouracil, Irinotecan, Oxaliplatin, and Leucovorin) will be:
~Day 1: Oxaliplatin at 85mg/m2 over 120 minutes, Irinotecan 180mg/m2 over 90 minutes, Leucovorin 400mg/m2 over 90minutes, 5-Fluorouracil (5-FU) 1200mg/m2/day continuous infusion (CIV) over 46 hours. Day 3: 5-FU CIV pump will be disconnected. Neulasta injection 6mg subcutaneous"
16040531|NCT02592395|Device|Electroporation|Irreversible electroporation (IRE) will be performed under computed tomography (CT) guidance, during which 2 to 6 needles are advanced into the pancreatic tumor where a specified field strength will be applied.
16040532|NCT02592382|Dietary Supplement|Xylitol spray|xylitol nasal spray will be administered to this arm three times daily for two months
16040533|NCT02592382|Other|Isotonic saline spray|saline nasal spray will be administered to this arm three times daily for two months
16040534|NCT02592369|Device|Medtronic CoreValve™ Evolut R™ System|The Evolut R System is intended for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, to be at high or extreme risk for open heart surgery. The Evolut R TAV treats aortic stenosis by displacing and functionally replacing the dysfunctional native valve with a bioprosthetic valve delivered on a catheter while the heart is still beating, thus avoiding the risks of cardiopulmonary bypass. Its intended performance is to relieve aortic valve stenosis without inducing significant regurgitation, thereby restoring effective aortic valve function.
16040535|NCT02592356|Procedure|Computed Tomography|Correlative studies
16040536|NCT02592356|Procedure|Dual X-ray Absorptiometry|Correlative studies
16040537|NCT02592356|Procedure|Physical Examination|Correlative studies
16040538|NCT02592356|Other|Quality-of-Life Assessment|Ancillary studies
16040539|NCT02592356|Other|Questionnaire Administration|Ancillary studies
16040540|NCT02592356|Drug|Cabozantinib|
16040541|NCT02592356|Drug|Lenvatinib|
16040542|NCT02592330|Procedure|Biopsy to collect limbal epithelial stem cells that will be cultivated into a graft|Cultivated autologous limbal epithelial cell (CALEC) therapy utilizes a bio-engineered composite of ex vivo expanded autologous corneal epithelial cells and an FDA-approved amniotic membrane (AmnioGraft®, Bio-Tissue, Inc.) to reconstruct the ocular surface. A small biopsy (2-3 mm2) from the patient's contralateral eye serves as a source epithelial (stem) cells that are expanded on the amniotic membrane in culture and the resulting product is surgically transplanted onto the cornea after excision of the fibrovascular pannus.
16040543|NCT02592330|Biological|Cultivation of Limbal epithelial cells into a graft|A graft is manufactured for transplant
16040544|NCT02592330|Procedure|CALEC Transplant|Limbal epithelial cells are obtained from the healthy fellow eye and cultivated in a lab for later transplantation into the diseased eye.
16040545|NCT02592317|Drug|JNJ 56021927|JNJ 56021927 will be adminitered once daily orally in a dose of 240 mg from Study Day 15 up to disease progression, unacceptable toxicity, withdrawal of consent, lost to follow-up, the participant is no longer receiving clinical benefit in the opinion of the Investigator, the start of subsequent anticancer therapy, or the Sponsor ends the study.
16040546|NCT02592317|Drug|Drug Cocktail|Drug cocktail comprise of midazolam (2 mg), warfarin (10 mg), vitamin K (10 mg), omeprazole (40 mg), and fexofenadine (30 mg) will be administerd on Study Day 1 and 43.
16040547|NCT02592317|Drug|Pioglitazone|Pioglitazone 15 mg will be administered orally on Study Day 8 and 50.
16040548|NCT02592317|Drug|Rosuvastatin|Rosuvastatin 15 mg will be administered orally on Study Day 9 and 51.
16040549|NCT02592304|Device|Dual energy computed tomography|one extra scanning with a dual energy ct.
16040550|NCT02592291|Device|MHealth|The Mhealth system consists of a suite of apps to support participants manage their self-care and the clinician portal. Participants will use the system for 1 year.
16040551|NCT02592278|Drug|Fluoride Varnish|Application of fluoride varnish every 3 and 6 months.
16040552|NCT02592278|Drug|Control Group|Twice a day brush with fluoride toothpaste.
16040553|NCT02592252|Behavioral|Participatory gender training|10 sessions of participatory gender training
16040554|NCT02592252|Other|Microfinance|Microfinance loan
16040555|NCT02592239|Device|Functional brain MRI|Functional brain MRI before and after test meal ingestion
16040556|NCT02592239|Dietary Supplement|A warm ham and cheese sandwich and a 200 ml fruit juice|
16040557|NCT02592226|Procedure|Anesthesia: alveolar recruitment maneuver|
16040558|NCT02592226|Procedure|Anesthesia: standardized|
16040559|NCT02592213|Procedure|Cell-assisted lipotransfer|Stromal vascular fraction, autologous. Isolated using Celution System (Cytori)
16040560|NCT02592200|Dietary Supplement|Lactobacillus gasseri DSM 27123|109 CFU (divided in two doses) per day for 28 days
16040567|NCT02592161|Drug|Experimental|"Test drug : Granules, Chung A Won 3g (Eucommiaceae, Psoralea corylifolia, Walnut, Ginger) Three times a day, oral administration for 24weeks
~Reference drug : Granules, Placebo 3g (Lactose hydrate, Corn starch, Caramel pigment)
~Three times a day, oral administration for 24weeks"
16040568|NCT02592135|Other|hsTnT level|hsTnT and NTproBNP levels at baseline and baseline plus 3 hours.
16040569|NCT02592122|Drug|Salbutamol Aerosol|
16040570|NCT02592122|Drug|No drugs|
16040571|NCT02592109|Behavioral|Enhanced Counseling using CFR based on Linear Programming|
16040572|NCT02592096|Drug|0.1% Pazufloxacin Mesilate Ear Drops|
16040573|NCT02592096|Drug|0.3% Pazufloxacin Mesilate Ear Drops|
16040574|NCT02592096|Drug|0.5% Pazufloxacin Mesilate Ear Drops|
16040575|NCT02592096|Drug|Pazufloxacin mesilate injection|
16040576|NCT02592083|Drug|Tamoxifen or Aromatase Inhibitor or Aromatase Inhibitor + goserelin|
16040577|NCT02592083|Drug|Palbociclib|
16040578|NCT02592070|Behavioral|Walking|Participants will walk on the treadmill for 30 minutes at a moderate intensity.
16040579|NCT02592057|Drug|SOF|SOF tablets administered orally once daily based on approved prescribing information
16040580|NCT02592044|Procedure|peripheral venous cannulation|The 18 gauge venous cannula will be inserted in a peripheral vein on the back of right hand of the patient.
16040581|NCT02592044|Procedure|Aromatherapy with lavender essential oil|The two drops of lavender essential oil will be dropped into the gauze and the patient will inhale it for 5 minutes and during venous cannulation.
16040582|NCT02592044|Procedure|Placebo|The two drops of water will be dropped into the gauze and the patient will inhale it for 5 minutes and during venous cannulation.
16040583|NCT02592031|Drug|XM17|300 IU corresponds to an injection volume of 0.5 mL.
16040584|NCT02592031|Drug|Gonal-f®|300 IU corresponds to an injection volume of 0.5 mL.
16040585|NCT02592031|Drug|Zoladex®|3.6 mg
16040586|NCT02592018|Drug|Secukinumab|Secukinumab 300mg SQ at weeks 0, 1, 2, 3, 4, and every 4 weeks thereafter until week 48. Skin biopsy procedures will be performed at weeks 0, 2, 4, and 12.
16040587|NCT02592005|Other|amount of fine dust and other environmental exposure|this study compares levels of exposure to to fine dust PM 2.5 by individual measurement both at home and at work
16040588|NCT02591992|Other|Cardiac CT as the first diagnostic modality in suspected CAD|Performation of non-invasive cardiac CT angiogram
16040589|NCT02591992|Other|Invasive coronary angiography as indicated by the guidelines|Patient undergoes invasive coronary angiography
16040590|NCT02591953|Procedure|Ultrasound-guidance|Using ultrasound-guidance to perform a corticosteroid injection
16040591|NCT02591953|Procedure|Landmark-guidance|Using landmark-guidance to perform a corticosteroid injection
16040592|NCT02591953|Drug|Methylprednisolone|Corticosteroid used in injection (40 mg)
16040593|NCT02591953|Drug|Lidocaine 1%|Anesthesic used in injection
16040594|NCT02591940|Procedure|Surgery or Treatment by Heart Catheter|
16040595|NCT02591927|Drug|Glucose-Insulin-Potassium|Rackley's GIK formula by continuous I.V. infusion at 1.5 ml/Kg/hour for 12 hours (about 100 ml/hour for a 70 kg patient).
16040596|NCT02591927|Drug|Glucose 5%|Glucose 5% (Placebo) by continuous I.V. infusion at 1.5ml/kg/hour for 12 hours (about 100 ml/hour for 70 Kg patient)
16040597|NCT02591914|Drug|Fovista™|Anti-PDGF-B pegylated aptamer
16040598|NCT02591914|Drug|Lucentis®|Anti-VEGF
16040599|NCT02591914|Drug|Avastin®|Anti-VEGF
16040600|NCT02591914|Drug|Eylea®|Anti-VEGF
16040601|NCT02591901|Drug|Uro vaxom|Prevention of recurrent symptomatic lower urinary tract infections
16040602|NCT02591901|Other|Placebo comparator|Placebo comparator
16040603|NCT02591888|Drug|Placebo|At the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure), those subjects in the placebo arm will have the 30ml of normal saline injected.
16040604|NCT02591888|Drug|Liposomal bupivacaine|At the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure), those subjects in the placebo arm will have the 30ml of dilutional liposomal bupivacaine injected.
16040605|NCT02591862|Drug|Coversin|Patients enrolled in this protocol will initially be treated with an ablating dose of Coversin and daily repeat maintenance doses calculated according to body weight, the ablating dose to be 0.57mg/kg. Thereafter the daily repeat dose will be titrated according to clinical response and complement inhibition determined by CH50 ELISA. The initial repeat dose will be 25% of the ablating dose and this will be adjusted up or down if necessary once steady state is reached (5 days).
16040606|NCT02591849|Dietary Supplement|Glucagon-like peptide-1 (GLP-1)|
16040607|NCT02591849|Other|Isotonic saline|
16040608|NCT02591849|Other|Hyperglycemic clamp|
16040609|NCT02591836|Drug|Gemcabene|Gemcabene
16040610|NCT02591836|Drug|Atorvastatin|Atorvastatin
16040611|NCT02591836|Drug|Placebo|
16040612|NCT02591810|Procedure|Serial casting/splinting|Serial Casting involves applying and removing a series of lightweight casts made of fiberglass. The wrist is monitored as healing occurs.
16040613|NCT02591810|Procedure|Percutaneous fixation|Injury is treated by the percutaneous placement of Kirschner wires to promote healing. This is an invasive procedure, involving the placement of Kirschner wires to stabilize the wrist.
16040614|NCT02591810|Procedure|Foveal repair|Injury is treated by open anatomic foveal repair of the ligaments. This is a surgical procedure.
16040615|NCT02591797|Procedure|inferior alveolar and lingual nerve block procedure|"The needle is inserted laterally to the pterygomandibular pit at its deepest point without noticing any resistance. In children the positioning of the syringe must be perpendicular, between the canine and the first molar on the opposite side and puncture is performed slightly below the occlusal plane. It was initially deposited 2/3 anesthetic carpule solution and then the needle is slightly recede depositing there the remaining third of anesthetic solution.
~The application of anesthesia shall be in accordance with the following guidelines:
~Topical Anesthetic: Benzocaine 20% (Hurricaine, Clarben Laboratories SA, Madrid, Spain).
~Dental Needle: short needles (21mm/30g) (Octoplus, Clarben Laboratories SA, Madrid, Spain)
~anesthetic: lidocaine hydrochloride 2% with epinephrine 1: 100,000 (2% XILOCAINE, Dentsply, Spain).
~Syringe: carpule syringe-conventional harpoon with suction system."
16040617|NCT02591784|Radiation|Radiotherapy|the Radiotherapy treatment;95%PTV A dose of 50-60Gy will be administered in 25-30 fractions ( 2 Gy /fraction)
16040618|NCT02591771|Drug|adrenaline|i.v. adrenaline infusion as an early and fast haemodynamic stabilizer, associated with a tight tissue perfusion monitoring, in the context of a stepwise progression in the treatment of cardiogenic shock, including ventricular mechanical support
16040619|NCT02591758|Device|Hexoskin Vest|The Hexoskin vest will be used at home to monitor the patient before and after the coronary angiography, during a treadmill test and during a home cardiac rehabilitation program.
16040620|NCT02591758|Behavioral|Cardiac rehabilitation program|A 6 sessions home cardiac rehabilitation program will be prescribed to the patient 2 to 4 weeks after the coronary angiogram. Those sessions will take place under Hexoskin surveillance. One session will take place at our specialized institution and six sessions will take place at home over the time span of two to three weeks.
16040621|NCT02591758|Other|Anxiety assessment as determined by the GAD-7|Anxiety assessment using the General Anxiety Disorder (GAD-7) scale, at the end of the study, to see if the Hexoskin relieved the anxiety patients can feel at home when exercising after a percutaneous coronary intervention.
16040622|NCT02591758|Other|Angina assessment with the angina diary, the SAQ and the SF-36|
16040623|NCT02591758|Other|Exercise stress test|Using the RAMP protocol before and after the coronary intervention, under Hexoskin surveillance.
16040624|NCT02591758|Other|Holter monitoring|24-hour Holter monitoring before and after the coronary angiogram with simultaneous Hexoskin reading.
16040625|NCT02591745|Procedure|Fetal intervention|Type of fetal conditions requiring intervention and medications administered to fetuses undergoing varying types of fetal intervention will be documeted in this database.
16040626|NCT02591719|Device|MagPro magnetic stimulator (HF rTMS)|Most activated area from fNIRS findings: Perilesional Broca's area. Use the true coil. High frequency rTMS (10Hz), Number of total stimuli: 800, Location: perilesional Broca's area, Intensity: 100% of resting motor threshold, Coil orientation: tangential to scalp, in combination with speech therapy(35-40min) after each rTMS session, Daily 10 treatment session
16040627|NCT02591719|Device|MagPro magnetic stimulator (sham)|Most activated area from fNIRS findings: Perilesional Broca's area. Use the sham coil. High frequency rTMS (10Hz), Number of total stimuli: 800, Location: perilesional Broca's area, Intensity: 100% of resting motor threshold, Coil orientation: tangential to scalp, in combination with speech therapy(35-40min) after each rTMS session, Daily 10 treatment session
16040628|NCT02591719|Device|MagPro magnetic stimulator (LF rTMS)|"Most activated area from fNIRS findings: Contralesional homologs of Broca's area.
~Use the true coil. Low frequency rTMS (1Hz), Number of total stimuli: 1200, Location: Contralesional homologs of Broca's area (Pars triangularis), Intensity: 90% of resting motor threshold, Coil orientation: tangential to scalp, in combination with speech therapy(35-40min) after each rTMS session, Daily 10 treatment session"
16040629|NCT02591706|Device|MIS Implants|The implantation procedure will be carried out according to a standard surgical protocol, and according the manufacture protocol. Patient will be randomly assigned to one of the two groups after flap opening. The implant stability will be measured using the wench key and recorded in N/cm. The implants will be covered with healing abutments for trans-gingival healing for a period of 4 months. The area will be sutured with thin nylon sutures for a primary passive fit closure. Immediately after the surgery the patient will perform a CBCT of the treated area with a cotton roll on the buccal side in order to be able to evaluate the buccal soft tissue thickness.
16040630|NCT02591693|Behavioral|Caregiver training|Occupational therapy training focuses on improving confidence to manage practical aspects of care in areas of daily life important to patient and caregiver, in which caregiver reports or anticipates low levels of confidence.
16040631|NCT02591680|Other|Neuromuscular training|
16040632|NCT02591680|Other|Muscle strengthening|
16040633|NCT02591680|Device|Sensorimotor|
16040634|NCT02591667|Procedure|Upfront staging laparoscopy + peritoneal biopsy|Upfront staging laparoscopy with biopsy of peritoneal tumor deposits, assessment of peritoneal cancer index and resectability.
16040635|NCT02591667|Drug|Neoadjuvant chemotherapy with FOLFOXIRI + bevacizumab|"Patients will receive 4 cycles of FOLFOXIRI + bevacizumab; the last cycle will be given w/o bevacizumab
~Dosage: Bevacizumab: 5 mg/kg via 30 min. IV infusion, day 1; Oxaliplatin: 85 mg/m2 via 2-hour IV infusion, day 1; Irinotecan: 165 mg/m2 via 1-hour IV infusion, day 1; Leucovorin: 200 mg/m2 via 2-hour IV infusion, day 1; 5-Fluorouracil: 3200 mg/m2 via 48-hour IV infusion, day 1;"
16040636|NCT02591667|Procedure|Surgical re-exploration|Three to 5 weeks after completion of FOLFOXIRI + bevacizumab chemotherapy, patients will undergo surgical re-exploration with the intent to perform a complete surgical cytoreduction. Further chemotherapy according to the currently available treatment guidelines, including intraperitoneal hyperthermic chemotherapy in patients where complete surgical cytoreduction has been achieved, may be given at the discretion of the investigator. Systemic chemotherapy may be started beginning 4 weeks post-surgery and after complete wound healing.
16040637|NCT02591654|Drug|Pembrolizumab|Each patient will receive pembrolizumab 200mg administered as a 30 minute intravenous (IV) infusion every 3 weeks for an indefinite period.
16040638|NCT02591654|Drug|FLT PET|FLT PET/CT is increasingly being utilized as an early PD biomarker in cancer given the close association between FLT uptake and proliferative index.
16040639|NCT02591641|Device|Anti-shear mattress overlay|A commercial full-length LiquiCell® anti-shear mattress overlay (ASMO) was placed on the standard ambulance stretcher mattress.
16040640|NCT02591641|Other|Standard of Care|Standard ambulance stretcher mattress
16040641|NCT02591628|Behavioral|HCTZ prescription conversion to chlorthalidone|The intervention is simply a prescription conversion and the main outcome is whether or not patients accept the conversion and treatment with chlorthalidone.
16040642|NCT02591615|Drug|MK-3475|Dose frequency of Q3W, Day 1 of each cycle
16040643|NCT02591615|Drug|Carboplatin|Dose frequency of Q3W, Day 1 of each cycle (standard Chemotherapy)
16040644|NCT02591615|Drug|Paclitaxel|Dose frequency of Q3W, Day 1 of each cycle (standard Chemotherapy)
16040645|NCT02591615|Drug|Pemetrexed|Dose frequency of Q3W, Day 1 of each cycle (standard Chemotherapy)
16040646|NCT02591602|Other|Teleradiology Service|Teleradiology Service at home or in nursing homes
16040647|NCT02591589|Other|Normoxic oxygenation|FiO2 set at 0.35 to maintain PaO2 > 70 mmHg or oxygen saturation greater than or equal to 92%.
16040648|NCT02591589|Other|Hyperoxic oxygenation|FiO2 set at 1.0 throughout the procedure
16040650|NCT02591537|Device|OxyGenesys Dissolved Oxygen Dressing|1/2 of the abdominal wounds will be covered with Oxygenesys Dissolved Dressing.
16040651|NCT02591524|Other|Bronchoalveolar and Nasal Lavage|A previously scheduled flexible bronchoscopy via the nasal route on the date of baseline visit combined with a nasal lavage and another nasal lavage after 6 month
16040652|NCT02591511|Device|smart phone and pad|Smart phone and pad is the mobile include the smart phone and pad, that can download the APP from internet.
16040653|NCT02591511|Other|stroke-related health education manual|stroke-related health education manual is the manual mainly contained information regarding the prevention of stroke risk factors.
16040654|NCT02591498|Behavioral|Computerized cognitive training|
16040655|NCT02591485|Behavioral|Attention Control Training|In the ACT, participants perform six computerized attention training sessions, 10 minutes per training session over six weeks. In each session the dot-probe task is administered. This task is consisted of 160 trials. Each trial began with a centrally-presented fixation cross that then replaced by a pair of words presented. Following that, a target probe appeared in the location previously occupied by one of the words, and participants are requested to discriminate the probe type via button press. Targets appear with equal probability at the location of threat and neutral stimuli, in order to modify the fluctuations in attention allocation.
16040656|NCT02591472|Procedure|Integrated care (ICare)|The Integrated Care approach provides Usual Care processes plus simultaneous psychosocial support via the Transform-10 Program. The Transform-10 Program will include information regarding emotional well-being, social support, and provides opportunity for the patient to openly discuss their thoughts and concerns regarding their recovery. The patient's normal clinical care usually includes a hospital stay, a 2 week follow up, 6 week follow up, 12 week follow up, 6 month, and 1 year follow up visit.
16040657|NCT02591472|Procedure|Usual Care (UsCare)|Usual Care includes radiographic imaging and administration of pain medication and antibiotics, skin care and range of motion of the injured area. The patient's normal clinical care usually includes a hospital stay, a 2 week follow up, 6 week follow up, 12 week follow up, 6 month, and 1 year follow up visit. At the end of the study all of the materials that make up the Transform-10 Program will be provided.
16040658|NCT02591472|Other|Patient-Reported Outcomes Measurement Information System|Questionnaires of Physical Functional quality of life and Emotional Well-being will be performed during the hospital stay, a 2 week follow up, 6 week follow up, 12 week follow up, 6 month, and 1 year follow up visit.
16040659|NCT02591472|Other|Lower Extremity Gain Scale (LEGS)|LEGS consists of a 3-meter walk, putting on a sock, putting on a shoe, rising from an armless chair, stepping up and down stairs, getting on and off the toilet, reaching from a sitting position to an object on the ground. In people with traumatic fractures, LEGS has high internal consistency and the content, concurrent and construct validity are high. This assessment will be performed during the hospital stay, at the 2 week follow up, 6 week follow up, 12 week follow up, 6 month, and 1 year follow up visit.
16040660|NCT02591472|Other|Dynamometer|Isometric handgrip strength will be measured using a hand-held hydraulic dynamometer. Handgrip strength is clinically important as it strongly predicts long-term function capability after orthopedic trauma. This assessment will be performed during the hospital stay, at the 2 week follow up, 6 week follow up, 12 week follow up, 6 month, and 1 year follow up visit.
16040661|NCT02591472|Other|Active Range of Motion (AROM)|The use of goniometer and a digital inclinometer will be used to assess AROM. This assessment will be performed during the hospital stay, at the 2 week follow up, 6 week follow up, 12 week follow up, 6 month, and 1 year follow up visit.
16040662|NCT02591472|Other|Posttraumatic Stress Disorder (PTSD)|The Posttraumatic Stress Disorder (PTSD) Checklist will be administered to measure posttraumatic stress levels. This assessment will be performed during the hospital stay, at the 2 week follow up, 6 week follow up, 12 week follow up, 6 month, and 1 year follow up visit.
16040663|NCT02591472|Other|Beck Depression Inventory-II|The Beck Depression Inventory-II is a broadly-applicable, clinically relevant psychometric instrument with high reliability and consistency which notes depression. This assessment will be performed during the hospital stay, at the 2 week follow up, 6 week follow up, 12 week follow up, 6 month, and 1 year follow up visit.
16040664|NCT02591472|Other|State-Trait Anxiety Inventory (STAI)|The State-Trait Anxiety Inventory (STAI) will be used to measure state anxiety (anxiety about an event) and trait anxiety (anxiety level as a personal characteristic). This assessment will be performed during the hospital stay, at the 2 week follow up, 6 week follow up, 12 week follow up, 6 month, and 1 year follow up visit.
16040665|NCT02591472|Other|Tampa Scale of Kinesiophobia-11 (TSK-11)|Tampa Scale of Kinesiophobia-11 (TSK-11) will be used to assess pain-related fear in orthopaedic trauma. This assessment will be performed during the hospital stay, at the 2 week follow up, 6 week follow up, 12 week follow up, 6 month, and 1 year follow up visit.
16040666|NCT02591459|Other|Using the app to assist routine anticipation|Using the app to assist routine anticipation for autistic children in Android mobile devices
16040667|NCT02591433|Other|Tobacco Cessation Counseling|Undergo JeffQuit group therapy
16040668|NCT02591433|Other|Support Group Therapy|Undergo JeffQuit group therapy
16040669|NCT02591433|Other|Quality-of-Life Assessment|Ancillary studies
16040670|NCT02591420|Biological|VRC01|40 mg/kg of VRC01 will be administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump
16040671|NCT02591420|Biological|Placebo for VRC01|Administered as an intravenous infusion over 30 to 60 minutes using a volumetric pump
16040672|NCT02591420|Drug|Antiretroviral therapy (ART) (regimen will vary within countries and by patient)|ART is provided by the study sites and consists of country guideline-recommended, available first line once-daily oral combination therapy: currently either efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg or efavirenz 600 mg/lamivudine 300 mg/tenofovir disoproxil fumarate 300 mg. This initial ART regimen may be adjusted or switched to an alternate regimen as clinically indicated for regimen intolerance or failure.
16040673|NCT02591407|Procedure|TAP Block|This is a one time injection of Exparel in the plane between the internal oblique and transversus abdominis muscles
16040674|NCT02591407|Procedure|Continuous Epidural Analgesia|Epidural catheter placed prior to the operation in the standard fashion
16040709|NCT02591147|Device|Group 2 (Placebo)|Group 2 (Placebo) subjects will receive application of sterile water (placebo) in addition to 5% Fluoride varnish to each approximal incipiency, using super floss, for a duration of 3 minutes under rubber dam isolation.
16040675|NCT02591394|Behavioral|STEP Clinic|Patients will visit with STEP clinic staff (including a stroke nurse practitioner or stroke doctor) to receive personalized goals, stroke education (including diet and exercise), instructions to self-monitor using blood pressure cuff, and prescription medications Patient will be scheduled for additional clinic follow-up or be contacted for telephone follow-up for management of your blood pressure. Questionnaires will be administered to determine medication adherence and persistence (following instructions for prescribed medication), disability, depression, cognition, self-efficacy, and sleep apnea. The care plan determined by the STEP clinic will be shared with the patient's primary care provider.
16040676|NCT02591394|Behavioral|Usual Care|"Patients will complete questionnaires related to medical history and health behaviors prior to initial visit.
~After being seen by the stroke neurologist, patients may be scheduled to return to the stroke clinic according the doctor's recommendations.
~Recommendations for blood pressure and risk factor monitoring will be sent to primary care providers."
16040677|NCT02591381|Procedure|Artificial Urinary Sphincter Placement|The AUS is the gold standard for treatment of severe stress urinary incontinence, particularly in patients following surgical resection of the prostate for prostate cancer. AUSs are small devices that prevent urinary flow via compression of the urethra, thus mimicking the native urinary sphincter.
16040678|NCT02591368|Procedure|Ligament reconstruction tendon interposition|In this procedure the trapezium is removed and one of the patient's own tendons (or portion of the tendon), usually the flexor carpi radialis or abductor pollicis longus, is passed through a drill hole in the thumb metacarpal and is used to suspend the first metacarpal base.
16040679|NCT02591368|Procedure|Suspensionplasty with one-suture construct|In this procedure the trapezium is removed and an Arthrex mini tightrope system using Fiberwire suture is drilled across the first metacarpal to the second metacarpal and is used to suspend the first metacarpal base instead of a tendon.
16040680|NCT02591368|Procedure|Suspensionplasty with two-suture construct|In this procedure the trapezium is removed and two Arthrex mini tightrope systems using Fiberwire sutures are drilled across the first metacarpal to the second metacarpal and are used to suspend the first metacarpal base instead of a tendon.
16040681|NCT02591355|Device|Autologous Platelet Rich Plasma|Autologous Platelet Rich Plasma a novel therapeutic modality used in numerous applications. In dermatology, its uses have included treatment of chronic wounds and facial rejuvenation. More recently, anecdotal reports have suggested some efficacy in the treatment of hair loss.
16040682|NCT02591355|Device|Saline solution injection|Placebo is a saline solution
16040683|NCT02591329|Behavioral|Mail-out hard copy materials (education plus self-regulatory strategies examples)|
16040684|NCT02591329|Behavioral|Standard Care|
16040685|NCT02591316|Other|no intervention|
16040686|NCT02591303|Other|Stress reactions measurement during stressful and neutral driving sessions|Stress effects will be measured during 3 driving sessions (training without events on Day 17, with neutral events on Day 18, with stressful events on Day19), through nighttime PSG and questionnaires.
16040687|NCT02591290|Biological|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, Intramuscular (2 doses with 8-week interval)
16040688|NCT02591277|Drug|Harvoni|Harvoni (90/400 mg) FDC tablet administered orally once daily
16040689|NCT02591264|Other|Blood sample|Blood sample drawn from participants for analysis of neutrophil peptide level
16040690|NCT02591251|Drug|Povidone-iodine solution|
16040691|NCT02591251|Drug|Normal saline solution|
16040692|NCT02591238|Other|non-smoker oral placebo|Participants oral placebo last 2 weeks.
16040693|NCT02591238|Drug|non-smoker oral melatonin|Participants oral melatonin 3 mg/day last 2 weeks.
16040694|NCT02591238|Other|smoker oral placebo|Participants oral placebo last 2 weeks.
16040695|NCT02591238|Drug|smoker oral melatonin|Participants oral melatonin 3 mg/day last 2 weeks.
16040696|NCT02591225|Drug|Dabigatranetexilate|After inclusion of the subjects with LA thrombus, they are treated according to the randomization either with Dabigatran (150 mg bid) or Phenprocoumon (INR adjusted once) for the treatment period of 12 months.
16040697|NCT02591225|Drug|Phenprocoumon|After inclusion of the subjects with LA thrombus, they are treated according to the randomization either with Dabigatran (150 mg bid) or Phenprocoumon (INR adjusted once) for the treatment period of 12 months.
16040698|NCT02591212|Behavioral|Green Dot|Green Dot bystander intervention program (www.livethegreendot.com) seeks to empower potential bystanders (students) to actively engage their peers in violence prevention. Intensive bystander training involves interactive, skill development with role-play of bystander behaviors. This program focuses on building knowledge and skills related to interpersonal violence and being an active bystander. There is a structured curriculum for both introductory sessions and longer, skill-building sessions.
16040699|NCT02591212|Behavioral|Wellness Initiatives for Student Empowerment|Wellness training to be provided in modules by Student Wellness ambassadors (http://www.uky.edu/wise). The Student Wellness Ambassadors mission is to inform students on aspects of wellness such as alcohol, drugs, mental health, general well-being, and financial wellness in orer to promote safe and responsible lifestyle decisions. Intervention will address elements of student wellness including campus resources for health issues, AOD abuse prevention/harm reduction strategies, time management and study tips, stress management and reduction, and healthy coping strategies. Training may also provide information on academic resources, money management, and other elements of healthy adaptation to college life.
16040700|NCT02591199|Drug|URG101|
16040701|NCT02591199|Drug|Placebo|
16040702|NCT02591199|Drug|Lidocaine|
16040703|NCT02591199|Drug|Heparin|
16040704|NCT02591186|Procedure|Acupuncture|Participants will receive 3 acupuncture sessions during IVF process
16040705|NCT02591173|Drug|Angiotensin-(1-7)|This is a biologically active endogenous angiotensin peptide. It may play an important role in the regulation of blood pressure by dilating blood vessels.
16040706|NCT02591173|Drug|Saline|Normal saline will be used as the placebo comparator.
16040707|NCT02591160|Procedure|HCTZ cessation|Patients will stop taking their HCTZ for 3 months
16040708|NCT02591147|Device|Silver Diamine Fluoride 38%|Group 1 (SDF group) subjects will receive the application of silver diamine fluoride (38% SDF solution) in addition to 5% Fluoride varnish to each approximal incipiency, using super floss, for a duration of 3 minutes under rubber dam isolation.
16040760|NCT02590757|Device|NIV-NAVA|Non-invasive neurally adjusted ventilatory assist
16040710|NCT02591134|Other|Non Nutritive Sweetened Beverages|Non-nutritive sweeteners (NNS) beverages encompass a range of carbonated and still drinks with added artificial sweeteners. Participants will be provided with a list of permitted beverages and are expected to consume at least two portions (330ml) per day.
16040711|NCT02591134|Other|Control|Water beverages provided in 330ml portions to be consumed twice per day over the duration of the trial
16040712|NCT02591108|Device|Neuromuscular Block Aid|Neuromuscular Block Aid, is a quantitative mechansim for collecting the the train-of-four and can be kept in an electronic medical record, also known as a train-of-four monitor, is used to assess neuromuscular transmission when neuromuscular blocking agents (NMBAs) are given to block musculoskeletal activity. By assessing the depth of neuromuscular blockade, peripheral nerve stimulation/monitoring can ensure proper medication dosing and thus decrease the incidence of side effects. Peripheral nerve stimulation is most commonly used for ongoing monitoring in the intensive care unit (ICU).
16040713|NCT02591108|Device|Standard of Care: Microstim Plus|A peripheral nerve stimulator, also known as a train-of-four monitor, is used to assess neuromuscular transmission when neuromuscular blocking agents (NMBAs) are given to block musculoskeletal activity. By assessing the depth of neuromuscular blockade, peripheral nerve stimulation/monitoring can ensure proper medication dosing and thus decrease the incidence of side effects. Peripheral nerve stimulation is most commonly used for ongoing monitoring in the intensive care unit (ICU).
16040714|NCT02591095|Drug|ABT-263|
16040716|NCT02591069|Device|stimulation device|All patients included in the study will undergo baseline assessment of all measures before surgery (implantation of a vagus nerve stimulation device). A second baseline assessment will take place after surgery, before the beginning of the stimulation. Stimulation intensity will start at 0.25mA and increase progressively by 0.25mA each week until reaching 1mA. Then, intensity will be set at 1.5mA (recommended by manufacturer) and will stay to this level until the end of the trial. Experimenters will keep the right to modify these parameters depending on patients' reaction to the treatment.
16040717|NCT02591056|Device|Erchonia® Verju™ Laser|There are 12 procedure administrations with the Erchonia® Verju™ Laser across 6 weeks: 2 procedures per week. For each procedure administration, the Erchonia Verju is applied to the midsection for 30 minutes: 15 minutes to the front and 15 minutes to the back. All subjects receive the active Erchonia Verju Laser treatment for all 12 procedure administrations.
16040718|NCT02591056|Device|Green PRESS 8|There are 12 procedure administrations with the Green PRESS 8 across 6 weeks: 2 procedures per week. For each procedure administration, the Green PRESS 8 is applied to the midsection for 30 minutes. All subjects receive the active Green PRESS 8 treatment for all 12 procedure administrations. Each Green PRESS 8 procedure administration occurs right after each procedure administration with the Erchonia Verju Laser.
16040719|NCT02591043|Procedure|Outcome after surgery|Functional outcome after surgical treatment of pelvic ring fractures Measurements: TUG-test score, ADLs index, maximal pain (VAS 1-10) at rest and experienced during TUG-test. One-year mortality, signs of healing, dislocation or other complications on anterior-posterior radiographs of the pelvis, living situation before and after the injury (at home/institutional placement)
16040720|NCT02591030|Drug|GEMCIS|"At D1 and D8 of each cycle, i.e. every 21 days for 6 months:
~Cisplatin 25 mg/m² over 1 hour at D1 and D8
~Gemcitabine 1000 mg/m² over 30 minutes at D1 and D8."
16040721|NCT02591030|Drug|mFolfirinox|"At D1 of each cycle, i.e. every 15 days for 6 months:
~Oxiplatin: 85 mg/m² (IP/120 minutes)
~Irinotecan: 180 mg/m² (IV/90 minutes)
~Folinic acid: 400 mg/m² (or 200 mg/m² if Elvorine [calcium levofolinate]) (IV/2 hours), via a Y connector at the same time as irinotecan
~5-FU: 2400 mg/m² (IV over 46 hours) without 5FU bolus at D1"
16040722|NCT02591017|Drug|Morphine|
16040723|NCT02591017|Drug|Ketamine|
16040724|NCT02591017|Drug|Placebo|
16040725|NCT02591017|Drug|Chitosan|
16040726|NCT02591004|Drug|Magesium sulphate|*Experimental: Group A: Magesium sulphate 4 gm intravenous (I.V) loading dose over 30 mins & 1 gm/ hour maintenance dose for 24 hours, or till labor occurs ( whichever occurs first)
16040727|NCT02591004|Drug|Nifedipine|*Active Comparator: Group B Nifedipine wil be given in a loading dose of 40 mg in the 1st hour (10mg will be given every 15 min), then a maintenance dose of 60mg /24 hours, divided in 3 doses
16040728|NCT02591004|Radiation|Doppler on fetal middle cerebral artery|both group A and group B: ultrasound doppler to measure the mean pulsility index (PI) and resistance index (PI) of the middle cerebral artery in the fetus twice, once before giving them the drug, and the other after 4 hours of starting the loading dose.
16040729|NCT02590991|Other|Prebiotics|To study the long term effect of supplementation in early life
16040730|NCT02590991|Other|Prebiotics & Probiotics|To study the long term effect of supplementation in early life
16040731|NCT02590978|Procedure|Early cholecystectomy|Cholecystectomy + intraoperative cholangiography within the first 72 hours of admission.
16040732|NCT02590978|Procedure|Control (Delayed cholecystectomy)|Standard care arm. Cholecystectomy + intraoperative cholangiography is delayed once complete resolution of abdominal tenderness, oral feeding and trending down in pancreatic laboratory is achieved
16040733|NCT02590965|Drug|Fruquintinib|After checking eligibility criteria, subjects will be randomized into Fruquintinib plus best supportive care group (treatment group) or placebo plus best supportive care group (control group) in a ration of 2:1.
16040734|NCT02590965|Drug|Placebo|Placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/1 week off
16040735|NCT02590952|Drug|Epitinib|The starting daily dose is 20 mg. Dose escalation will follow daily dose of 40 mg,80 mg, 120 mg, 160 mg, 200 mg, and 250 mg. A 3+3 design applies to this study. Patients will continue taking Epitinib until they experience intolerable adverse events or their diseases are confirmed to be progressed.
16040736|NCT02590939|Device|CEFALY Active|Active external trigeminal nerve stimulation
16040737|NCT02590939|Device|CEFALY Placebo|Placebo external trigeminal nerve stimulation
16040738|NCT02590926|Procedure|Fractional Flow Reserve, Myocardial|The ratio of maximum blood flow to the myocardium with coronary stenosis present, to the maximum equivalent blood flow without stenosis.
16040761|NCT02590757|Device|N-CPAP|Nasal-continuous positive airway pressure
16040739|NCT02590913|Dietary Supplement|fructose|75g fructose is dissolved in 300 ml water.After overnight fasting, 300ml of solution at 0830 within 5 minutes is taken by volunteers
16040740|NCT02590913|Dietary Supplement|glucose|75g glucose is dissolved in 300 ml water.After overnight fasting, 300ml of solution at 0830 within 5 minutes is taken by volunteers
16040741|NCT02590900|Drug|intravenous paracetamol (acetaminophen)|paracetamol disposition in young women, exploring the impact of covariates (pregnancy, postpartum, oral contraceptives) in this population.
16040742|NCT02590887|Dietary Supplement|Drink manufactured from lupine peptides|Comparison of blood levels of immune, oxidative stress, biochemical markers and haemogram before and after (14, and 28 days) drinking the beverage.
16040743|NCT02590874|Drug|Duloxetine|Duloxetine 30 mg per day for 2 weeks. Duloxetine 60 mg per day for 4 months. Duloxetine 30 mg per day for 2 weeks.
16040744|NCT02590874|Drug|Placebo|Placebo 30 mg per day for 2 weeks. Placebo 60 mg per day for 4 months. Placebo 30 mg per day for 2 weeks.
16040745|NCT02590861|Procedure|Dental implant|All participants will receive the same intervention, this is a single group study.
16040746|NCT02590848|Dietary Supplement|Walnut intake|Nutritional intervention: 30g walnut kernels per day
16040747|NCT02590835|Procedure|Orthodontic procedures (for both groups : Control group and Test group)|Damon self-ligating systems (Ormco, Orange, Calif) were used for all patients. The patients were allowed to choose between clear or metal brackets. The bonding method was standardized and applied according to the manufacturer's instructions. After bracket bonding, 0.014-in copper-nickel-titanium Damon arch forms were placed. The subjects were recalled every two weeks, and the archwires were changed only when full bracket engagement was achieved. The sequence of archwires was as follows: 0.018-in, 0.014x0.025-in and 0.018x0.025-in copper nickel-titanium archwires for alignment; and 0.019x0.025-in stainless steel archwires for fine-tuning. Following the alignment steps, impressions were taken, and blinded orthodontic consultants validated appliance removal or provided advice regarding further adjustments. Alginate impressions were taken after the removal of the appliances, and both fixed and removable retainers were placed.
16040748|NCT02590835|Procedure|Piezo-assisted orthodontics (only the Test group)|The piezocisionTM surgery was performed one week after orthodontic appliance placement . The patients received local anesthesia in both arches, and vertical interproximal micro-incisions were created below each interdental papilla. In cases of root proximity (i.e., less than 2 mm of interdental bone), this procedure was not applied. These incisions were kept to a minimum (varying from 5 mm to 8 mm). Next, using a vertical piezoelectric device, 5-mm long and 3-mm deep corticotomies were made, and no subsequent sutures were required needed (figure 1). The patients were advised to take analgesics (paracetamol) only if necessary and to record their daily intakes for one week. Anti-inflammatories were prohibited to avoid interference with the RAP. Careful tooth brushing and the use of a mouthwash (chlorhexidine 0.2% Perio-Aid, Dentaid Benelux, Houten, Netherlands) were recommended for 7 days.
16040749|NCT02590822|Dietary Supplement|Cambridge Weight Plan|"Group receives a total meal replacement diet from Cambridge Weight Plan containing 810 kcal/day (40% protein, 50% carbohydrate, 10% fat). As 3 or 4 mini-meals daily in flavoured formula food packets made up with water, milk or non-dairy alternative; or as snack bars based on preference. Supplemented with up to three portions of non-starchy vegetables and 2 litres of water, or other non-calorific drinks, per day. Participants to abstain from alcohol for study duration. The diet will be stopped, and a maintenance diet re-introduced once 50% excess body weight has been lost, or by 12 weeks, whichever comes first.
~The TDR will be undertaken alongside health behaviour coaching and relapse prevention through weekly, where possible, contact (telephone or face-to-face) with a qualified dietician or equivalent.
~Due to the potential risk of hypoglycaemia and symptomatic hypotension; medication at enrolment will need to be adjusted initially and throughout the study."
16040750|NCT02590822|Other|Supervised Exercise Sessions|"The exercise group will attend supervised exercise sessions at the Leicester-Loughborough Diet, Lifestyle and Physical Activity (LLP) BRU or at the Leicester Diabetes Centre. The exercise program will typically consist of a thrice weekly, 60 minute session of moderate intensity aerobic exercise, in line with prevailing guidelines. An initial assessment of cardiorespiratory fitness will be performed, and exercise intensity titrated to aim for a workload of approximately 60% of the patient's VO2 max.
~Due to the potential risk of hypoglycaemia and symptomatic hypotension; medication at enrolment will need to be adjusted initially and throughout the study."
16040751|NCT02590809|Drug|Treatment BX1514M|X mg x 3 /day of BX1514M for 15 days. Dosage will be then adapted, depending on symptoms release and walk distance test results for another 15 days period.
16040752|NCT02590809|Drug|Placebo|Placebo will be given for 30 days
16040753|NCT02590809|Other|Walk distance test|Walk distance test during 6 minutes
16040754|NCT02590809|Other|Exercise echocardiography|
16040755|NCT02590796|Other|No intervention given to participants|This is an observational study. Participants will receive no intervention.
16040756|NCT02590783|Procedure|experimental intervention surgery|Patients are placed supine on the carbon table. Screw paths are planned on a spiral CT scan from the sacrum on transversal slices, two Kirschner-wires 2.5 mm in diameter are introduced into the iliac bone through a stab incision and advanced into the ilio-sacral joint, through the lateral part of sacrum into the first and second sacral body, through the contralateral lateral part of the sacrum and exiting the contralateral iliac bone through the sacra-iliac joint with aid of CT-guidance. Over the Kirschner-wires 7.0 mm cannulated screws are introduced and the Kirschner-wires withdrawn. Several low-dose computer tomography scans are performed to secure the correct position. Total radiation dose is 300 mille gray square centimetres (mGycm).
16040757|NCT02590783|Procedure|control intervention|Mobilization guided by our physiotherapists. Full weight bearing is allowed. Analgetic treatment with metamizol, ibuprofen or paracetamol to the attending physicians discretion under regular surveillance laboratory values and/ or morphine or methadone. Patients will be treated with an individually based approach, if necessary involving our anesthesiologic pain service. Thrombo-embolic prophylaxis with a low molecular weight heparin or rivaroxaban for 6 weeks unless there is an indication for oral anticoagulation. All patients will be followed up by the Geriatric Fracture Center considering osteoporosis, fall prophylaxis, malnutrition and delirium. For the duration of the study the patients will not receive Parathyroid Hormone Substitution or Phosphonates.
16040758|NCT02590770|Behavioral|attention modification|participants will receive gaze-continent feedback according to their viewing patterns
16040759|NCT02590770|Other|Placebo|participants will receive non-gaze-continent feedback unrelated to their viewing patterns
16040764|NCT02590718|Procedure|optimized postoperative management|lying without the pillow for half an hour after lumbar puncture
16040765|NCT02590705|Drug|Lidocaine|surface anesthesia with lidocaine
16040766|NCT02590692|Biological|CPCB-RPE1|Patients will receive one CPCB-RPE1 implant of approximately 100,000 differentiated RPE cells attached to a small parylene membrane. The density of cells on the membrane represents the approximate density of RPE cells in the human eye. The membrane size was chosen to cover a substantial portion of the macular region of the retina.
16040767|NCT02590679|Device|Venues-P Valve|a Novel Self-Expanding Percutaneous Stent-Valve in the Native Right Ventricular Outflow Tract
16040768|NCT02590666|Procedure|Bipolar Polypectomy|Polyps resection with bipolar electrode
16040769|NCT02590666|Procedure|Mechanical Polypectomy|Polyps resection with microscissors or graspers
16040770|NCT02590666|Device|Bipolar electrode|Bipolar electrode used to performs polypectomy
16040771|NCT02590666|Device|Microscissors or graspers|Mechanical instruments used to performs polypectomy
16040772|NCT02590653|Drug|Atorvastatin|Lipid-lowering therapy
16040773|NCT02590640|Device|Repetitive transcranial magnetic stimulation, MagStim Rapid2|"This study plans to learn more about the way an experimental technique called transcranial magnetic stimulation (TMS) affects a specific part of the brain, called the insula. Some research suggests that this part of the brain plays an important role in craving. The investigators plan to study the effects of TMS using standard surveys and magnetic resonance imaging (MRI) of subjects' brain."
16040774|NCT02590640|Device|Sham repetitive transcranial magnetic stimulation|Sham repetitive transcranial magnetic stimulation will be applied to the insula in smokers.
16040775|NCT02590627|Drug|Artemether-lumefantrine|Artemether-lumefantrine
16040776|NCT02590627|Drug|Dihydroartemisinin-piperaquine|Dihydroartemisinin-piperaquine
16040777|NCT02590614|Dietary Supplement|800 IU Vitamin D|Among the cross-sectional study participants, a subset is randomly selected and matched based on genetic ancestry, and randomized to the intervention group.
16040778|NCT02590614|Dietary Supplement|Placebo|Among the cross-sectional study participants, a subset is randomly selected and matched based on genetic ancestry, and randomized to the placebo group
16040779|NCT02590601|Drug|Bromocriptine|
16040780|NCT02590601|Other|Guideline-driven medical therapy (GDMT)|
16040781|NCT02590588|Drug|Idelalisib|Idelalisib daily until unacceptable toxicity or disease progression.
16040782|NCT02590575|Device|Extracorporeal CO2 removal with the Prismalung(R) gas exchanger on the Prismaflex(R) renal replacement platform|"With ongoing continuous hemofiltration and mechanical ventilation additional membrane gas exchange device (Prismalung®) in the renal replacement circulation; measurements of the effects on PaCO2 under varying blood and sweep gas flows
~Afterwards, reduction of the tidal volume (VT) / plateau pressure until reaching the initial PaCO2value"
16040783|NCT02590562|Other|Routine clinical practice|
16040784|NCT02590549|Procedure|Corneal Collagen Crosslinking|"Sterile riboflavin solution 0.1% was then continuously injected for 3 minutes into the corneal pocket via a standard 0.3-mm cannula through the incision tunnel.
~Standard surface UVA irradiation (370 nm, 3 mW/cm2) was then applied at a 5-cm distance for 30 minutes.
~After UVA irradiation, a flexible MyoRing intracorneal implant was inserted into the corneal pocket,"
16040785|NCT02590549|Device|Ufalink|UVA irradiation with wave length 370 nm, 3 mW/cm2 is provided with UFalink, device,Russian Federation
16040786|NCT02590536|Drug|Sildenafil citrate|"In patients with Fetal Growth Restriction (FGR)and abnormal umbilical artery Doppler, will be randomly assigned and divided to 2 groups which will be treated with sildenafil citrate either placebo.
~This study will compare the change in Resistance Index (RI) and the Pulsatility Index (PI) of the umbilical artery and fetal middle cerebral artery, for patients who receive 25 mg of oral sildenafil citrate 8 hourly starting at diagnosis of FGR until delivery against those who will receive placebo of the same color and shape of sildenafil citrate tablet."
16040787|NCT02590536|Drug|placebo|
16040788|NCT02590523|Drug|Vancomycin|Intracameral vancomycin injection during cataract surgery
16040789|NCT02590523|Drug|Moxifloxacin|Intracameral moxifloxacin injection during cataract surgery
16040790|NCT02590523|Drug|Placebo|Intracameral placebo injection with BSS during cataract surgery
16040791|NCT02590510|Drug|methotrexate|The quantity of methotrexate is different in the two groups.
16040792|NCT02590497|Procedure|Diffusion Weighted Imaging|Undergo diffusion weighted MRI
16040793|NCT02590497|Drug|Gadolinium|Undergo gadolinium-enhanced MRI
16040794|NCT02590497|Other|Laboratory Biomarker Analysis|Tissue genetic analysis
16040795|NCT02590497|Procedure|Magnetic Resonance Imaging|Undergo gadolinium-enhanced MRI
16040796|NCT02590497|Procedure|Magnetic Resonance Imaging|Undergo 3D volumetric T1-weighted sequence
16040797|NCT02590497|Procedure|Magnetic Resonance Imaging|Undergo FLAIR sequence
16040798|NCT02590497|Procedure|Perfusion Magnetic Resonance Imaging|Undergo perfusion MRI
16040799|NCT02590484|Procedure|The cervix as a natural tamponade (cervical inversion)|Suturing an inverted lip(s) of the cervix over the bleeding placental bed to control the bleeding.
16040800|NCT02590471|Procedure|Angioplasty with stenting of the femoral artery|"A standard endovascular exposure is carried out under local anesthesia and a lesioned arterial segment is visualized. Stenosis or artery occlusion is passed by the hydrophilic guide. During the occlusion transluminal or subintimal artery recanalization (most frequently mixed) is conduced. Then balloon angioplasty of stenosis or occlusion are carried out. After the angiographic control if necessary stent (balloon extpandable or self-expanding) of all the extension is mounted.
~Medical therapy includes aspirin (acid acetylsalicylic) prescription before the procedure (160 - 300 mg/d), beginning from minimum per day and heparin (heparin sodium) injection during the procedure (5000 U iv). After the procedure aspirin (acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and plavix (clopidogrel) in dose 75/d should be prescribed within 3 months."
16040827|NCT02590237|Device|Miller Direct Laryngoscopy|At time of tracheal intubation, the subject will be intubated using a Miller blade laryngoscope. The first attempt to successful intubation will be assessed. The Cormack Lehane and Percentage of Glottic Opening scores will be recorded. Information on time to glottic view, time to removal of the blade, and time of first capnography upstroke (successful intubation) will be recorded. Other parameters measured will be information on subsequent attempts, ease of tracheal tube insertion, and hemodynamic responses for 5 minutes.
16040801|NCT02590471|Procedure|Angioplasty with stenting of the femoral artery, supplemented by fasciotomy in Hunter's channel|"Standard endovascular stenting of femoral artery. The exposure is carried out to the distal part of superficial femoral artery when it lives Hunter's canal and the first portion of popliteal artery. Intermuscular vastoadductoria sept is dissected and the following arteries are ligated and dissected: а. superior medialis genus, а. superior lateralis genus.
~Medical therapy includes aspirin (acid acetylsalicylic) prescription before the procedure (160 - 300 mg/d), beginning from minimum per day and heparin (heparin sodium) injection during the procedure (5000 U iv). After the procedure aspirin (acid acetylsalicylic) in dose 100 mg/d within long period should be prescribed in all the patients, and plavix (clopidogrel) in dose 75/d should be prescribed within 3 months."
16040802|NCT02590458|Procedure|Short Breast MRI (SBMRI)|One day after routine MRI, short breast MRI (SBMRI) with contrast performed. Scan will take about 10 minutes to complete.
16040803|NCT02590458|Behavioral|Questionnaire|After SBMRI, participant completes a questionnaire about their comfort level and experience of the research scan. It should take about 10 minutes to complete the questionnaire.
16040804|NCT02590445|Device|deep brain stimulation system|
16040805|NCT02590432|Drug|Linaclotide|Linaclotide capsules, orally, once daily.
16040806|NCT02590419|Device|BrightMatter™ products|"BrightMatter™ Plan (BMP): BMP is a software that enables surgeons to plan their neurosurgery preoperatively. BMP automatically generates whole brain tractography and highly accurate fusion of anatomical MRI and DTI images.
~BrightMatter™ Bridge (BMB):BMB involves offering SMI's MRI expertise to ensure a smooth workflow in neuroimaging including DTI to ensure optimized protocols are used to acquire the DTI images. Once the images are acquired, they are evaluated for their quality in real time using a quality control (QC) algorithm. The QC allows quality assessment of DTI images at the time-of-scan allowing for immediate correction while the patient is still there and reduces the need for patient re-scan.
~BrightMatter™ Guide (BMG): BMG is a neuro-navigation system that utilizes the DTI information and the trajectory planned by the surgeon in BMP pre-operatively, but bringing it into the operating room intraoperatively."
16040807|NCT02590406|Procedure|Beach chair (BC) and ZEEP|Table Position: Beach chair, Inclination of the upper part of the table at 25 degrees, breaking at the patient's hips ZEEP: 3 minutes pre-oxygenation with tidal volumes, FiO2 100%, mouth piece used as a ventilatory interface
16040808|NCT02590406|Procedure|Reverse Trendelenburg and NIPPV|"Table Position: Reverse Trendelenburg, Inclination of the whole table at 25 degrees from an horizontal plane, head up.
~NIPPV: 3 minutes of pre-oxygenation with 8 cm H2O positive pressure and 10 cm H2O PEEP. Trigger set at 1,5 L/min, mouth piece is used as a ventilatory interface"
16040809|NCT02590393|Combination Product|E-cigarettes|Participants will be asked to switch from cigarette use to use of e-cigarettes for eight weeks.
16040812|NCT02590367|Drug|FOLFOX regimen|"FOLFOX regimens are combination therapy of oxaliplatin (85 mg/m^2) administered as a 2-hour infusion on Day 1; leucovorin (400 mg/m^2) administered as a 2-hour infusion on Day 1; followed by a loading dose of 5-fluorouracil (5-FU; 400 mg/m^2) IV bolus administered over approximately 2 to 4 minutes on Day 1, then 5- FU (different dose like FOLFOX4/FOLFOX6) via ambulatory pump administered for a period of 46 to 48 hours.
~XELOX is a combination therapy of Oxaliplatin 130mg/ m^2 d1 Intravenous infusion, every 3 weeks. and Capecitabine 1000mg/m^2 bid, days 1-14, every 3 weeks."
16040813|NCT02590367|Drug|HD6610 Granule|the HD6610 Granule will be given 2 times a day.
16040814|NCT02590367|Drug|HD6610 Granule placebo|the HD6610 Granule placebo will be given 2 times a day.
16040815|NCT02590354|Other|ART interruption|
16040816|NCT02590315|Other|Invitation for breast screening and random allocation|Invitation for breast screening; Women who consent to take part in the trial will be randomised to DBT or DM.
16040817|NCT02590315|Device|DBT|Combo-mode DBT. DBT participants will have an additional radiation exposure for breast tomosynthesis.
16040818|NCT02590315|Device|Conventional digital mammography.|Conventional digital mammography.
16040819|NCT02590302|Other|Implementation Phase|"Core Components of the implementation intervention include:
~Hospital and CMHA project commitment
~Site champion teams (from hospital and CMHA)
~Memorandum of Agreement between Hospital and CMHA
~Pre-intervention site visits
~Education sessions
~Posters/reminders
~Instructional videos (HEADS ED video)
~Completed pathway implementation includes EDMHCP site-customization and committee approvals, consequent planning and agreements among ED-CMHA partners, delivery of at least two educational workshops, and EDMHCP availability in the ED. An 8-month period for EDMHCP implementation, with negotiated interim target dates was set for each site."
16040820|NCT02590289|Drug|BBI-5000|BBI-5000 low dose, middle dose, or high doses
16040821|NCT02590276|Behavioral|characterization|
16040822|NCT02590263|Radiation|Whole Brain Radiation|Whole Brain Radiation will be administered in over 30 fractions as per the procedure in each study site.
16040823|NCT02590263|Drug|Temozolomide|Temozolomide will be administered per label.
16040824|NCT02590263|Drug|ABT-414|ABT-414 will be administered by intravenous infusion
16040825|NCT02590250|Biological|botulinum toxin Type A|Botulinum toxin Type A treatment for Neurogenic Detrusor Overactivity or Overactive Bladder as per local standard of care in clinical practice.
16040826|NCT02590237|Device|Ambu KingVision Video Laryngoscope aBlade|At time of tracheal intubation, the subject will be intubated using the Ambu KingVision Video Laryngoscope with a size 1 aBlade. The first attempt to successful intubation will be assessed. The Cormack Lehane and Percentage of Glottic Opening scores will be recorded. Information on time to glottic view, time to removal of the blade, and time of first capnography upstroke (successful intubation) will be recorded. Other parameters measured will be information on subsequent attempts, ease of tracheal tube insertion, and hemodynamic responses for 5 minutes.
16040828|NCT02590224|Drug|Ferrous bis-glycinate|
16040829|NCT02590224|Drug|Ferrous glycine sulphate|
16040866|NCT02589925|Procedure|NBM stimulation|bilateral low-frequency neurostimulation of the subthalamic nucleus using a Vercise neurostimulation system
16040923|NCT02589600|Other|Saline|Annual intravenous saline placebo
16040830|NCT02590211|Behavioral|cognitive, emotional and clinical assessment|Cognitive and emotional assessment: Posner paradigm applied to emotional information (attention and emotional perception abilities), the modified Wisconsin Card Sorting Test (mental flexibility), the Hayling Sentence Completion Task (verbal inhibition), the Go - No Go test (motor inhibition) and the expressive suppression method (facial expression inhibition) Clinical assessment: gambling course and habits, level of cognitive distortions, control attribution (locus of control), social phobia, motivation for gambling, impulsivity, co-addictions, coping and gambling related-damage
16040831|NCT02590198|Other|ANAES algorithm|care as recommended by ANAES, with ANAES algorithm
16040832|NCT02590198|Other|PCT algorithm|care based on PCT algorithm
16040833|NCT02590185|Drug|cocktail probe drugs|"For the assessment of drug-metabolizing enzyme activity, the patients will be given the cocktail probe drugs, by oral route, one time during the study:
~A capsule of omeprazole ABBOTT® 10mg
~10 mg of an oral liquid formulation of Dextrométhorphane bromhydrate (Drill Pierre FABRE MEDICAMENT® 5mg/5mL, syrup)
~1 mg of an injectable solution of Midazolam for oral administration (Midazolam Panpharma® 1mg/mL, injectable solution)
~A tablet of fexofenadine Zentiva® 120mg"
16040834|NCT02590159|Device|BONGO NASAL EPAP|The BONGO NASAL EPAP device consists of two nasal inserts (a connected pair), each containing an actuated valve, with a patient attachment mechanism. The device works by providing an inhalation port that offers minimal inhale resistance during inhalation, but is closed by the actuated valve so that exhalation occurs against a fixed orifice. This mechanism provides increased EPAP upon exhalation.
16040835|NCT02590146|Behavioral|Non-pharmacologic pain control adjuncts|
16040836|NCT02590133|Drug|Recombinant Human Endostatin Injection (Endostar)|15mg/m2/d, continuous intravenous infusion in 2ml/h for 30 days each cycle, 60 days as one cycle, 6 cycles in total
16040837|NCT02590133|Drug|Fluorouracil (5-Fu)|200mg/m2/d, continuous intravenous infusion in 2ml/h for 30 days each cycle, 60 days as one cycle, 6 cycles in total
16040838|NCT02590133|Drug|Nedaplatin|80mg/m2/d, intravenous drip on d1 and d28 each cycle, 60 days as one cycle, 6 cycles in total
16040839|NCT02590120|Dietary Supplement|Enteral nutrition|
16040840|NCT02590107|Dietary Supplement|Boost Plus|Receive nutritional supplementation twice daily to provide 28g of protein
16040841|NCT02590107|Dietary Supplement|Pro-Stat 101|Receive nutritional supplementation twice daily to provide 30g of protein
16040842|NCT02590107|Dietary Supplement|Milkshake|Receive alternate nutritional supplementation once daily to provide 28g protein
16040843|NCT02590107|Other|daily food diaries|Participants will be given a food intake form, clipboard, and pen to record specific foods, as well as amounts of foods that are consumed from outside sources. In addition, the specific food items that each participant consumes will be recorded by the participant on his or her meal tickets which are included with each meal tray
16040844|NCT02590094|Drug|Intravitreal bevacizumab or intravitreal ziv-aflibercept|Intravitreal bevacizumab or intravitreal ziv-aflibercept is given preoperatively at various time intervals and doses.
16040845|NCT02590081|Drug|Dextrose 5%|
16040846|NCT02590081|Drug|normal saline|
16040847|NCT02590068|Drug|Zoster vaccine live|Single Zostavax vaccine, 0.65 ml dose, administered subcutaneously
16040848|NCT02590055|Drug|gemcitabine/docetaxel combination|
16040849|NCT02590042|Biological|ADSC-SVF-002|"ADSC-SVF with the following identity:
~Less than or equal to 10% each CD34 and CD45 positive cells At least 70% each CD90, CD73 and CD105 positive cells Viability of at least 85% Mean Florescence Intensity of less than or equal to 100 C12FDG 0-5-2.5x10^6 cells/g of liposuctioned (hydrated fat)"
16040850|NCT02590029|Behavioral|Mindfulness|The 15 minute mindfulness session is a scripted mindfulness exercise that incorporates mindfulness principles of intentionally paying attention to present-moment experience in a non-judgmental fashion.
16040851|NCT02590029|Behavioral|Suggestion|The 15 minute suggestion session is a scripted suggestion exercise that incorporates imagery and suggestions for changes in cognition, emotion, and body sensations.
16040852|NCT02590029|Behavioral|Psychoeducation|The 15 minute psychoeducation session is a supportive session in which behavioral coping strategies for pain management are discussed.
16040853|NCT02590016|Drug|Insulin, Aspart|Insulin aspart Novorapid® Penfill 40 IU/0,4 ml is diluted into 1000ml of 0,9 % sodium chloride (NaCl). Infusion is started at rate 48 ml/l, which equates insulin dosing at rate of 2 IU/h. Glucose infusion is started simultaneously. 5 ml of potassium chloride (KCl) is added to 500 ml of 10 % Glucose solution. Infusion rate is 100 ml/h giving glucose infusion rate of 10 g/l. Plasma glucose level is measured every 1-2 hours and infusion rate of insulin is increased by 6ml/h if plasma glucose is more than 7,5 mmol/l and decreased by 6 mmol/h if plasma glucose is below 4 mmol/l.
16040854|NCT02590003|Drug|Carboplatin|
16040855|NCT02590003|Drug|Nab-paclitaxel|
16040856|NCT02589990|Behavioral|Strength training|see arm description
16040857|NCT02589977|Drug|regadenoson|evaluation of myocardial blood flow, interstitial fibrosis and oxidative metabolism in HFpEF, compared to hypertensive and normal participants
16040858|NCT02589964|Dietary Supplement|Florajen-3|The probiotic treatment is the experimental aspect of the study. Treatment will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days.
16040859|NCT02589964|Other|Placebo|The placebo treatment is the experimental aspect of the study. Treatment will be initiated within 48 hours of the first antibiotic and will be administered twice a day for 20 days.
16040860|NCT02589951|Other|admission to non-psychiatric service|
16040861|NCT02589938|Other|Standard Oral Hygiene|Oral hygiene care provided per individual institutions standard of care.
16040862|NCT02589938|Other|Standard Oral Hygiene + True Acupuncture|Oral hygiene care provided per individual institutions standard of care. 14 true acupoint sites will be selected and applied to each participant for 20 minutes at each session. There will be 2 sessions a week for 8 weeks.
16040863|NCT02589938|Other|Standard Oral Hygiene + Sham Acupuncture|Oral hygiene care provided per individual institutions standard of care. 14 sham acupoint sites will be selected and applied to each participant for 20 minutes at each session. There will be 2 sessions a week for 8 weeks.
16040864|NCT02589925|Device|Vercise deep brain stimulation|implantation of a Vercise neurostimulation system
16040865|NCT02589925|Procedure|subthalamic nucleus (STN) stimulation|bilateral high-frequency neurostimulation of the subthalamic nucleus using a Vercise neurostimulation system
16041008|NCT02589002|Other|Sucralose|
16040867|NCT02589925|Procedure|sham stimulation|ineffective neurostimulation by setting 0mA output at the Vercise neurostimulation system
16040868|NCT02589912|Device|Nucleus Profile ABI541 Auditory Brainstem Implant|
16040869|NCT02589899|Other|Needle placement in different tissue types|Bioimpedance will be measured for needle positions in different tissue types
16040870|NCT02589886|Other|Education and self-help internet intervention|The intervention is a newly developed website which consists of information about the mechanism and treatment of functional motor disorders. Furthermore self-help elements like exercises to perform at home and rehabilitation advice are added. The intervention is unguided.
16040871|NCT02589873|Behavioral|In-Person Diabetes Prevention Program|Lifestyle intervention program involving group-based educational sessions, diet and physical activity tracking, and weekly weigh ins. Participants complete the intervention over 12 months.
16040872|NCT02589873|Behavioral|Online Diabetes Prevention Program|Lifestyle intervention program involving web-based educational videos, diet and physical activity tracking, and recording weight. Participants complete the intervention over 12 months.
16040873|NCT02589860|Other|Melphalan kinetic study|Concentration of Melphalan in plasma samples
16040874|NCT02589860|Genetic|Oral bacterial study|DNA from oral buccal mucosal cells will be sequenced for bacterial composition
16040875|NCT02589860|Genetic|Gene expression study|RNA from oral buccal mucosal cells will be analyzed to compare gene expression
16040876|NCT02589847|Biological|RBX2660|suspension of intestinal microbes
16040877|NCT02589847|Drug|Standard of Care Antibiotics|Standard of Care Antibiotics
16040878|NCT02589834|Other|Quran group|
16040879|NCT02589821|Drug|Surufatinib|Surufatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle
16040880|NCT02589821|Other|Placebo|Placebo 300 mg once a day (QD) will be orally administrated on a 28-day cycle
16040881|NCT02589808|Device|Full TTE|Full transthoracic echocardiogram, with Doppler.
16040882|NCT02589808|Device|GE Vscan|Handheld echo.
16040883|NCT02589795|Biological|DNA-C CN54ENV|DNA plasmid containing the Clade C gp140 envelope gene from HIV-1 isolate CN54
16040884|NCT02589795|Biological|CN54gp140|Recombinant protein expressed from the Clade C gp140 envelope gene from HIV-1 isolate CN54
16040885|NCT02589795|Device|Trigrid Delivery System - Intramuscular|Electroporation
16040886|NCT02589795|Device|Trigrid Delivery System - Intradermal|Electroporation
16040887|NCT02589782|Drug|Bedaquiline|
16040888|NCT02589782|Drug|Pretomanid|
16040889|NCT02589782|Drug|Moxifloxacin|
16040890|NCT02589782|Drug|Linezolid|
16040891|NCT02589782|Drug|Clofazimine|
16040892|NCT02589782|Drug|Locally accepted standard of care which is consistent with the WHO recommendations for the treatment of M/XDR-TB.|
16040893|NCT02589769|Other|unsaturated fat for saturated fat|Substituting unsaturated fat for saturated fat
16040894|NCT02589769|Other|saturated fat|a control diet with whole fat dairy and meat with saturated fats that are not fat reduced
16040895|NCT02589756|Other|The fatty fish group|At inclusion demographic information recorded, including length of breastfeeding for women. Thereafter, participants will start with a run-in period of two weeks where they will be asked not to consume salmon, mackerel, sardines or other fatty fish or nuts providing a dietary baseline. At baseline, subjects will be randomized to a fish, nuts or control group. The fish group will be asked to consume three to four portions weekly. The fish will be eaten at the main meal and in sandwiches for a total of 600 grams weekly for 6 months. This group will avoid eating nuts. The nut group will consume equal amount of energy (~1400 kcal ) for weekly use for 6 months. This group will avoid eating fatty fish. The control group will consume their usual diet, but asked to avoid fatty fish and nuts.
16040896|NCT02589756|Other|The nut group|At baseline (conditions for baseline are the same in all three groups) the nut group will consume equal amount of energy (~1400 kcal ~100 grams walnuts, ~50 grams hazelnuts and ~50 grams almonds/week).The nuts will be provided free of charge for the six months. This group will avoid eating fatty fish.
16040897|NCT02589756|Other|The control group|After the baseline the control group will consume their usual diet, asked to avoid fatty fish and nuts.
16040898|NCT02589743|Device|Sealant|Application of preventive agent
16040899|NCT02589743|Device|Adhesive and Sealant|Application of preventive agent and technique for control moisture
16040900|NCT02589730|Device|Welltang App|This App is a large platform of individualized diabetic management
16040901|NCT02589717|Drug|Atezolizumab [TECENTRIQ]|Atezolizumab 1200 mg will be administered by IV infusion q3w. Initial IV infusion will be given over 60 minutes and subsequent infusions will be given over 30 minutes.
16040902|NCT02589691|Drug|Rocuronium|
16040903|NCT02589691|Other|Sodium chloride 0.9%|
16040904|NCT02589678|Biological|Tdap - IPV Vaccine|Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed, combined with inactivated poliomyelitis vaccine (0.5 ml) will be administered intramuscularly.
16040905|NCT02589678|Biological|MMR Vaccine|A live attenuated virus vaccine against measles, mumps and rubella (0.5 ml) will be administered intramuscularly.
16040906|NCT02589665|Drug|Mirikizumab|
16040907|NCT02589665|Drug|Placebo|
16040908|NCT02589652|Drug|Pegylated interferon alfa-2a|ETV 0.5mg oral daily plus PegIFN alfa-2a 180ug subcutaneous injection weekly for 8 weeks and followed by PegIFN alfa-2a 180ug subcutaneous injection weekly for 40 weeks
16040909|NCT02589652|Drug|Pegylated interferon alfa-2a plus Entecavir|ETV 0.5mg oral daily plus PegIFN alfa-2a 180ug subcutaneous injection weekly for 48 weeks
16040910|NCT02589652|Drug|Entecavir|ETV 0.5mg oral daily for 48 weeks
16040911|NCT02589639|Drug|Empagliflozin|
16040912|NCT02589639|Drug|Placebo|
16040913|NCT02589639|Drug|Placebo|For blinding purposes
16040914|NCT02589626|Drug|empagliflozin 10mg|
16040915|NCT02589626|Drug|empagliflozin 25 mg|
16040916|NCT02589626|Drug|Placebo|For blinding purposes
16040917|NCT02589613|Dietary Supplement|tap water|300ml tap water via nasogastric tube
16040918|NCT02589613|Dietary Supplement|Glucose|300ml tap water with 75g Glucose via nasogastric tube
16040919|NCT02589613|Dietary Supplement|Fructose|300ml tap water with 25g Fructose via nasogastric tube
16040920|NCT02589600|Drug|Zoledronic acid|Annual intravenous 5.0 mg
16040924|NCT02589587|Procedure|sleeve gastrectomy|Sleeve gastrectomy is an established form of bariatric (weight reducing) surgery, where the greater curvature of the stomach is removed.
16040925|NCT02589587|Other|no intervention|lean control group
16040926|NCT02589574|Other|electronic text message|"Besides the reminder of the free vaccination, the messages included information that vaccination reduces the personal risk of influenza illness. It also reduces the risk to infect patients and family members. It is also the social expectation on and professional as well as personal responsibility of nurses in protecting own selves and their patients from contacting influenza.
~it is a safe vaccine. The reminders are developed with reference to promotion messages from Hospital Authority."
16040927|NCT02589561|Device|Remote fitting|remote fitting of hearing aids
16040928|NCT02589561|Device|Face to face fitting|face to face fitting of hearing aids
16040929|NCT02589522|Drug|Berzosertib|Given IV
16040930|NCT02589522|Other|Quality-of-Life Assessment|Ancillary studies
16040931|NCT02589522|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16040932|NCT02589522|Radiation|Whole-Brain Radiotherapy|Undergo whole-brain radiation therapy
16040933|NCT02589509|Behavioral|Direct-attention training using web-based BrainHQ|"BrainHQ (by Posit Science Corp.) computerized attention training using the following modules: Divided attention, Target tracker, Double Decision, Mixed Signals, and Freeze Frame."
16040934|NCT02589509|Behavioral|Goal Management Training (GMT)|A compensatory metacognitive strategy-based intervention program that teaches strategies for improving attentional control and problem solving.
16040935|NCT02589496|Drug|pembrolizumab|200 mg every 3 weeks
16040936|NCT02589483|Procedure|The rectal anastomosis will be reinforced with HemoPatch.|Associated with the making of the anastomosis stapled or hand sewed, the device HemoPatch will be wrapped all the way around the anastomotic circumference.
16040937|NCT02589483|Device|Hemopatch|The rectal anastomosis reinforced with Hemopatch
16040938|NCT02589470|Other|COMETE|Patients of COMETE group will attend 12 individual sessions of cognitive rehabilitation, which are not systematic in usual treatment, and will receive memory exercises via internet to continue cognitive exercizes at home.
16040939|NCT02589457|Drug|CKD-390|Tenofovir Disoproxil Aspartate 1T PO
16040940|NCT02589457|Drug|Viread® tablet|Tenofovir Disoproxil Fumarate 1T PO
16040941|NCT02589444|Dietary Supplement|High-Dose Vitamin D3|50,000 IU of oral vitamin D3 once a week (the standard of care for repletion of vitamin D status by the Cystic fibrosis Foundation)
16040942|NCT02589444|Other|Stool Sample|Participants will be asked to provide a stool sample in a collection container for analysis of stool microbiota. This will be done upon enrollment (baseline) and at 3 month follow-up.
16040943|NCT02589444|Other|Sputum Sample|"Participants will be asked to collect their sputum (the thick mucus or phlegm that is expelled from the lower respiratory tract through coughing) into a kit.
~This will be done upon enrollment (baseline) and at 3 month follow-up."
16040944|NCT02589444|Other|Sham Comparator|A placebo capsule taken once a week (manufactured by the same company that makes the Vitamin D supplement).
16040945|NCT02589444|Procedure|Blood draw|Participants will be asked to provide 30 ml of blood collected via a blood draw to measure 25 (OH)D serum concentration and other nutrient markers related to vitamin D including Parathyroid hormone, fibroblast growth factor-23, vitamin D binding protein and markers of immune system/inflammation. This will be done at baseline and at 3 months follow up.
16040946|NCT02589418|Procedure|Acupuncture|Needle insertion and manipulation at 4 acupuncture points (bilateral LI4, right ST6 and ST7).
16040947|NCT02589418|Procedure|Sham-Acupuncture|Needle insertion and manipulation at 4 non-acupoints
16040948|NCT02589418|Procedure|No Acupuncture|Control intervention: No needle insertion and manipulation
16040949|NCT02589405|Drug|Benzoyl Peroxide|
16040950|NCT02589405|Other|Dermotivin® Soft Liquid cleanser|
16040951|NCT02589405|Other|Cetaphil® Dermacontrol Moisturizer SPF30|
16040952|NCT02589392|Other|Cetaphil® Restoraderm® moisturizer + Cetaphil® Restoraderm® body wash|
16040953|NCT02589392|Other|Cetaphil® Restoraderm® body wash|
16040954|NCT02589379|Procedure|Pancreatic Resection|Endoscopic ultrasound elastography, intraoperative ultrasound elastography and magnet resonance imaging to asses pancreatic stiffness prior to pancreatic resection
16040955|NCT02589366|Drug|Lymphoseek plus Vital Blue Dye|intrapatient comparison of Lymphoseek with Vital Blue Dye in detecting lymph node metastases
16040956|NCT02589353|Drug|Acarbose|Acarbose solution will be swabbed on the tip of the tongue to inhibit salivary alpha amylase activity; each swab will contain ~484 microgram acarbose; total maximum exposure of each subject to acarbose will be ~14-30 mg each session (1-20 sessions)
16040957|NCT02589340|Drug|Buspirone|
16040958|NCT02589340|Drug|Placebo|Sugar Pill
16040959|NCT02589327|Other|Exercise Intervention|The intervention will consist of 3 weeks of whole body circuit training (resistance training) where participants in the intervention group will perform 7 different exercises. The circuit will consist of 10 repetitions per exercise of 7 exercises: leg press, bent-over row, bench press, squats, dumbbell jump squats with raises, dead-lifts and weighted abdominal crunches, with approximately 30 sec of rest in between each exercise (based on the estimated time needed to move from one position to the next). Each participant will move through the circuit 3 times, with 2 to 3 minutes of rest between each round. Intensity will be 6-7 of RPE at the first set, and 9-10 at the third set.
16040960|NCT02589314|Device|Mechanical periodontal therapy|
16040961|NCT02589314|Procedure|nonsurgical periodontal therapy|
16040962|NCT02589301|Biological|Pegfilgrastim|
16040963|NCT02589288|Procedure|Continuous Infusion of ropivacaine 0.2%|Postoperative continuous infusion of Ropivacaine 0,2% at 6 ml/h and 4 ml PCA bolus, lockout 20 minutes via electronic infusion pump (Micrel device, Greece).
16040964|NCT02589288|Procedure|Automatic Intermittent Bolus of ropivacaine 0.2%|Postoperative Automatic Intermittent Bolus of 6 ml Ropivacaine 0,2% every hour and 4 ml PCA bolus, lockout 20 minutes via electronic infusion pump (Micrel device, Greece).
16040965|NCT02589275|Drug|TNX-102 SL Tablet 2.8 mg|TNX-102 SL 2.8 mg tablet taken daily at bedtime
16040966|NCT02589262|Drug|AUT00206|
16040967|NCT02589249|Dietary Supplement|AyuFlex|Active product
16040968|NCT02589249|Dietary Supplement|Placebo|Placebo
16040969|NCT02589236|Drug|Cavosonstat|GSNOR inhibitor
16040970|NCT02589236|Drug|Placebo|Control sample with only capsule excipients and fillers
16040971|NCT02589223|Other|Multisensory Stimulation|Subjects assigned to the multisensory stimulation group will receive the multisensory stimulation protocol designed for the study, which will include a variety of techniques designed to awaken the individual. Stimulus provided may include: visual activities (i.e. presenting the individual with objects/pictures to look at), auditory information (i.e. playing music or speaking), tactile stimuli (i.e. touching the individual with materials of different textures), taste and smell stimuli (i.e. offering items for the individual to taste or smell).
16040972|NCT02589223|Other|Control|Intervention sessions will occur 3 times per week, for approximately 30 minutes per session for a total of 4 weeks. During each session, subjects will be played a pre-recorded reading of complex material for 30 minutes, in order to assist with control/blinding.
16040973|NCT02589210|Other|EpiFix Mesh|Weekly application of EpiFix Mesh and standard of care (moist wound therapy and offloading)
16040974|NCT02589197|Device|Group 1 (Medial-Pivot)|EVOLUTION® Total Knee Arthroplasty Medial Pivot system with CS inserts
16040975|NCT02589197|Device|Group 2 (Posterior-Stabilized)|Zimmer® NexGen® Total Knee Arthroplasty system with PS inserts
16040976|NCT02589184|Other|Hypergravity|the rubber bands attached to the waist belt are tighten to simulate extra gravity during every exercise the subject performs while standing
16040977|NCT02589184|Other|isometric load|at the end of the therapy session the subject will perform 2 sets of one minute each of a 33% squat under load
16040978|NCT02589184|Other|normal gravity|the rubber bands attached to the waist belt are NOT tighten so the subject performs the exercises in normal gravity
16040979|NCT02589171|Device|Neo Close Abdominal Closure|Neo Close Abdominal Closure
16040980|NCT02589171|Device|Carter Thomason Device|Carter Thomason Device
16040981|NCT02589158|Drug|Evotaz|All participants will be administered Evotaz®) (atazanavir 300mg + cobicistat 150mg) once daily for 10 days
16040982|NCT02589158|Drug|Rezolsta|All participants will be administered Rezolsta® (darunavir 800mg + cobicistat 150mg) once daily for 10 days.
16040983|NCT02589145|Drug|Lenalidomide|"Dose Escalation Phase Starting dose of Lenalidomide: 50 mg by mouth on Days -9 to -2.
~Dose Expansion Phase Starting Dose: Maximum tolerated dose from Phase I."
16040984|NCT02589145|Drug|Vorinostat|1000 mg by mouth on Days -9 to -2.
16040985|NCT02589145|Drug|Gemcitabine|Gemcitabine administered as a loading dose of 75 mg/m2 by vein on Day -8 and 2775 mg by vein on Day -3.
16040986|NCT02589145|Drug|Busulfan|"Busulfan test dose administered by vein either as outpatient before admission, or as inpatient on day -10. The test dose of 32 mg/m2 based on actual body weight. Doses of days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1."
16040987|NCT02589145|Drug|Melphalan|60 mg/m2 by vein on days -3 and -2.
16040988|NCT02589145|Drug|Rituximab|Patients with CD20+ tumors receive Rituximab 375 mg/m2 by vein on day -9 in the AM as an inpatient.
16040989|NCT02589145|Drug|Dexamethasone|8 mg by vein twice a day from Day -8 AM to Day -2 PM.
16040990|NCT02589145|Drug|Caphosol|Caphosol oral rinses 30 mL four times a day used from Day -8.
16040991|NCT02589145|Drug|Glutamine|Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
16040992|NCT02589145|Drug|Pyridoxine|100 mg by vein or mouth three times a day from Day -1
16040993|NCT02589145|Drug|Enoxaparin|40 mg subcutaneously daily from admission until platelet count drops below 50,000/mm3.
16040994|NCT02589145|Procedure|Stem Cell Transplant|Stem cell transplant performed on Day 0.
16040995|NCT02589145|Drug|Palifermin|Palifermin per departmental standard of care with 3 doses to be administered prior to starting chemotherapy and 3 doses starting on day 0.
16040996|NCT02589132|Other|Mobile-Thrive application|Families receive standard of care plus the Mobile-Thrive application
16040997|NCT02589119|Drug|MSC-AFP|Eligible patients will be treated with a fistula plug that has been coated with autologous mesenchymal stromal cell.
16040998|NCT02589106|Device|Anisotropic Textile Braces|The period of the wear trial is 12-18 months in time for each subject. Wear instructions (23 hrs per day) and wash instructions will be provided to the subjects before the wear trial. Evaluation tests based on health in consideration of the use of the anisotropic textile brace (heart and pulmonary function testing and sensory level measurements) will be carried out at the beginning of the wear trial. Clinical, radiography, self-report and follow-up after completion of the study
16040999|NCT02589093|Device|Stimulation|
16041000|NCT02589080|Behavioral|Non-invasive sensory feedback|"A non-invasive simple sensory feedback system, which provides the user of a prosthetic hand with sensory feedback on the arm stump. It is mediated by air in a closed loop system connecting silicone pads on the prosthetic hand with pads on the amputation stump. The silicone pads in a tactile display on the amputation stump expand when their corresponding sensor-bulb in the prosthesis is touched, evoking an experience of real touch. Most amputees experience phantom limb sensations and/or phantom limb pain, as well as residual limb stump pain. There is often a map of the phantom hand on the amputation stump, where pressure on specific skin areas result in evoked sensation from specific fingers in the amputated phantom hand. This map is the target for the sensory feedback."
16041001|NCT02589067|Drug|Chlorhexidine gluconate|Oral rinse of either 0.12% Chlorhexidine Gluconate oral rinse to test the safety/efficacy of 0.12% Chlorhexidine Gluconate oral rinse in decolonizing the oropharynx of children colonized with S. aureus.
16041002|NCT02589067|Drug|Saline Placebo|Placebo saline oral rinse to to test the safety/efficacy of 0.12% Chlorhexidine Gluconate oral rinse in decolonizing the oropharynx of children colonized with S. aureus.
16041003|NCT02589054|Other|Monitoring|
16041004|NCT02589041|Procedure|intraneural sciatic nerve injection|"A popliteal intraneural sciatic nerve block will be performed under ultrasound guidance. Minimal effective volume will be evaluated performing a randomization based on the Up-and-down methodology.
~A baseline and postoperative electrophysiological study will assess the presence of any neurological complication."
16041005|NCT02589041|Drug|Ropivacaine 1%|
16041006|NCT02589028|Dietary Supplement|premeal protein-enriched bar intake|Premeal protein bar is provided 30 minutes before breakfast. Participants have to eat protein bar with in 5 minutes with 150ml of water.
16041007|NCT02589028|Other|breakfast follows by protein bar|Participants have to eat provided breakfast within 30 minutes. It is recommended for participants to eat protein bar shortly after finishing breakfast within 5 minutes.
16041009|NCT02588976|Device|Sonoclot Analyzer|Blood coagulation test during cardiac surgery: Measurement of activated clotting time during cardiac surgery by Sonoclot Analyzer
16041010|NCT02588963|Other|Health education session|It was created an education health session regarding the prevention of respiratory infections of children, according to caregivers needs. This session have a theoretical component, addressing especially modifiable risk factors of respiratory infections in children, and a practical component where caregivers can learn and practice nasal clearance techniques, demonstrated by the physiotherapist.
16041011|NCT02588963|Other|Nasal clearance Protocol|Nasal clearance protocol consists on the application of physiological serum in the nostrils of the child, followed by the stimulation of nasal inspiration in order to remove mucus from the nose and nasopharynx. The protocol is applied for 3 consecutive days, according to established criteria suggested by Postiaux.
16041012|NCT02588963|Other|Control|Children proceeded to their normal activities at the daycare; Caregivers did not attend to education health session.
16041013|NCT02588950|Drug|U-500R|Administered SC
16041014|NCT02588937|Drug|EntecaBell ODT. 0.5mg|
16041015|NCT02588937|Drug|Baraclude Tab. 0.5mg|
16041016|NCT02588924|Other|Second University of Naples|enrollment of patients with Parkinson's disease; collection of blood samples; measuring out the concentrations of copper, iron and manganese in biological fluids (blood, serum) of patients with Parkinson's disease and of subjects of the control group and assess possible correlations between changes in the content of metals and the pathology.
16041017|NCT02588924|Other|Neuromed IRCCS|enrollment of patients with Parkinson's disease; collection of blood samples;
16041018|NCT02588911|Procedure|Conventional Surgery|Cranial ligation of the great saphenous vein and branches of the sapheno-femoral junction and stripping of the great saphenous vein
16041019|NCT02588911|Procedure|Radiofrequency Ablation|Catheter-based ablation of the great saphenous vein
16041020|NCT02588898|Device|Blood collection and electrophysiological tests|Blood collected using a conventional method. Electrophysiology was tested after nerve Stimulation. Medical history and symptoms were collected after a standardized interview.
16041021|NCT02588885|Behavioral|Trauma-sensitive Care|"Psychological intervention
~education
~empowerment
~desensitization
~relaxation tools
~Physical therapy intervention
~techniques to address muscular tension
~empowerment
~comfort
~encouragement of trauma-related coping skills"
16041022|NCT02588872|Biological|Platelet-rich Plasma (PRP)|
16041023|NCT02588872|Biological|Hyaluronic Acid|
16041024|NCT02588846|Device|Combined real-time use of 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring'|This intervention uses the simultaneous combined use of two technologies: 'Multi-Leaf Collimator Adaptation' and 'kV Intrafraction Monitoring'. kV Intrafraction Monitoring (KIM) measures the motion of tissues targeted for radiotherapy in real time using kV imaging.The multi-leaf collimator (MLC) reshapes the radiation beam to maximise dose to the target tissue and minimise dose to the surrounding healthy tissue. Combining KIM and MLC allows the shaped radiation beam to follow the moving target (the prostate) while remaining fixed on a stationary target (lymph nodes) that are also being treated at the same time.
16041025|NCT02588833|Drug|Pegcetacoplan|Complement (C3) Inhibitor
16041026|NCT02588820|Drug|Antiretroviral Therapy (Experimental)|"Initial ART until HLA-B5701 results became available (48 hours):
~Tenofovir 245 mg once a day
~Emtricitabine 200 mg once a day
~Dolutegravir 50 mg once a day
~Darunavir 800 mg once a day
~Ritonavir 100 mg once a day
~Maraviroc 150 mg twice a day
~Three months continuation treatment (after HLA-B5701 confirmed as negative):
~Dolutegravir 50 mg once a day.
~Abacavir 600 mg once a day
~Lamivudine 300 mg once a day
~Darunavir 800 mg once a day
~Ritonavir 100 mg once a day
~Maraviroc 150 mg twice a day The whole treatment schedule comprises 7 pills per day (in a single dose), except for maraviroc, which will be given twice daily.
~Nine months continuation treatment (till complete 12 months treatment):
~Abacavir, 600mg once a day
~Lamivudine, 300 mg once a day
~Dolutegravir, 50 mg once a day"
16041027|NCT02588807|Drug|Spirit1|Spirit 1 is a combination of phospholipids and anti-oxidant medicinal plants
16041028|NCT02588794|Device|CytoSorb 300 ml device (3804606CE01)|additional cytokine adsorber
16041029|NCT02588781|Drug|Pemetrexed|Alimta 500mg/m2 + NS 100ml IV infusion for 10mins Every 3weeks
16041030|NCT02588768|Device|Photobiomodulation therapy (Phototherapy)|PBMT was applied employing MR4 Laser Therapy Systems manufactured by Multi Radiance Medical, Solon - OH, USA. The cluster emitter contains 12 diodes with four super-pulsed laser diodes (905 nm, 0.3125 mW average power, and 12.5 W peak power for each diode), four red LED diodes (640 nm, 15 mW average power for each diode), and four infrared LEDs diodes (875 nm, 17.5 mW average power for each diode). It was applied in direct contact with the skin to 9 sites on extensor muscles of the knee, 6 sites on knee flexors of the knee, and 2 sites on the calf of both lower limbs. To ensure blinding, the device emitted the same sounds and regardless of the programmed mode (active or placebo).
16041031|NCT02588755|Procedure|TACE+Tegafur|Tegafur: 40mg bid for 3 continuous months in 4 months. TACE: 4 or 8 weeks after resection.
16041032|NCT02588755|Procedure|TACE|TACE alone
16041033|NCT02588742|Dietary Supplement|Melatonin|Patients in the melatonin group are given 5mg of melatonin at 8 pm the day before surgery, POD#0, POD#1, POD#2, POD#3, POD#4, and POD#5.
16041034|NCT02588742|Dietary Supplement|Placebo|Patients in the control group are given placebo at 8 pm the day before surgery, POD#0, POD#1, POD#2, POD#3, POD#4, and POD#5.
16041035|NCT02588729|Other|Pregnant+ app for smartphone|The Pregnant+app for smartphone with information about a healthy diet, physical activity and management of gestational diabetes mellitus.
16041036|NCT02588716|Drug|Terlipressin|Terlipressin will be given as an intravenous injection of 2μg/kg/h to be continued throughout the surgery and weaned off over four hours postoperatively.
16041037|NCT02588716|Drug|normal saline|Same volumes of normal saline infusion, throughout the operation then gradually withdrawn over 4 hours.
16041038|NCT02588703|Behavioral|Cognitive Behavioral Therapy|Coping Skills Treatment
16041039|NCT02588703|Behavioral|Usual Care|Existing DUI program group counseling
16041040|NCT02588690|Procedure|Fingerstick cholesterol test|A finger stick draws approximately four drops of blood. The total cholesterol (TC), High Density Lipoprotein Cholesterol (HDL-C), Triglycerides, Low Density Cholesterol (LDL-C), and Glucose tests are done.
16041120|NCT02588105|Drug|Olaparib|Module 1 combination with olaparib
16041121|NCT02588105|Drug|irinotecan|Module 2 combination with irinotecan/FOLFIRI
16041041|NCT02588690|Other|Atherosclerosis Cardiovascular Disease Risk assessment|"This Risk Estimator enables estimation of 10-year and lifetime risks for atherosclerotic cardiovascular disease (ASCVD), defined as coronary death or nonfatal myocardial infarction, or fatal or nonfatal stroke, based on the Pooled Cohort Equations and lifetime risk prediction tools. The Risk Estimator is intended for use in those without ASCVD with a LDL-cholesterol <190 mg/dL.
~The information required to estimate ASCVD risk includes age, sex, race, total cholesterol, HDL cholesterol, systolic blood pressure, blood pressure lowering medication use, diabetes status, and smoking status."
16041042|NCT02588690|Procedure|Blood pressure measurement|Blood pressure measurement
16041043|NCT02588677|Drug|Masitinib (4.5)|4.5 mg/kg/day
16041044|NCT02588677|Drug|Riluzole|
16041045|NCT02588677|Drug|Placebo|
16041046|NCT02588677|Drug|Masitinib (3.0)|3 mg/kg/day
16041047|NCT02588664|Other|COMPASS Intervention|"A Post-Acute Coordinator (PAC) will visit each patient prior to discharge from the hospital.
~Patient will receive a follow-up telephone call two days after having been discharged.
~7-14 days after discharge, the patient will attend post-acute stroke clinic visit and receive an assessment from an Advanced Practice Provider (APP), a brief patient-reported functional assessment to generate an individualized Care Plan, and referrals from an APP. The patient's primary caregiver will be assessed to ensure caregiver availability and ability to support the patient and the caregiver's ability to cope with the new challenges of caregiving.
~Patient will receive a call at 30 and 60 days post-discharge for follow-up of functional status, recovery, risk factor management and their access or utilization of recommended services."
16041048|NCT02588651|Drug|Brentuximab vedotin|study drug given intravenously to determine efficacy in study diseases
16041049|NCT02588625|Drug|BMS-986020|
16041050|NCT02588625|Other|Placebo|
16041051|NCT02588612|Drug|letetresgene autoleucel (GSK3377794)|letetresgene autoleucel (GSK3377794) as an IV infusion.
16041052|NCT02588612|Drug|Cyclophosphamide|Cyclophosphamide will be used as a lymphodepleting chemotherapy.
16041053|NCT02588612|Drug|Fludarabine|Fludarabine will be used as a lymphodepleting chemotherapy.
16041054|NCT02588599|Device|Erchonia LUNULA|Active low level laser light therapy
16041055|NCT02588586|Drug|3BNC117|3BNC117 infusions
16041056|NCT02588586|Other|Antiretroviral Treatment Interruption|Antiretroviral therapy will be discontinued 2 days after the third 3BNC117 infusion, at week 24, and resumed at week 36.
16041057|NCT02588573|Device|etafilcon A (control)|contact lens
16041058|NCT02588573|Device|somofilcon A (test)|contact lens
16041059|NCT02588547|Drug|Granisetron|IV granisetron 1 mg before spinal anethesia
16041060|NCT02588547|Drug|Granisetron|IV granisetron 0.7 mg before spinal anethesia
16041061|NCT02588547|Drug|Sodium chloride|IV 2 ml 0.9 sodium chloride before spinal anethesia
16041062|NCT02588534|Device|etanercept (ENBREL®) via auto-injector device|single 50 mg subcutaneous dose of liquid etanercept (ENBREL®) in a 1.0 ml pre-filled syringe administered via an auto-injector device manufactured by Scandinavian Health Limited (SHL)
16041063|NCT02588534|Other|Etanercept (ENBREL®) via Manual injection|single 50 mg subcutaneous dose of liquid etanercept (ENBREL®) in a 1.0 ml pre-filled syringe administered via manual injection (reference treatment) to compare to the auto-injection
16041064|NCT02588521|Drug|AL-794|
16041065|NCT02588521|Other|Placebo/Vehicle|Suspension vehicle without active drug
16041066|NCT02588508|Procedure|Warm packs|: The warm packs are held in the mother's perineum during birth. The warm packs are changed as needed to maintain warmth.
16041067|NCT02588508|Procedure|Perineal massage|"The perineal massage will be gently held in the longitudinal direction of the muscle fibers, with movements of the thumb and forefinger, like count coins."
16041068|NCT02588495|Other|Food intake|Either drinking a cup of clear liquid, or having a cup of coffee and a muffin
16041069|NCT02588482|Device|high-density electroencephalography|Auditory stimulations during electroencephalography recording
16041070|NCT02588482|Device|Conventional electroencephalography|Auditory stimulations during electroencephalography recording
16041071|NCT02588469|Other|Interventional group|"Venous compression leads to beneficial fluid regulation in OSA participants and appears as an efficient tool in OSA management.
~To the investigators knowledge no study assess the impact of the cumulative effect of physical and venous compression program on upper airway resistances in obese teenager with OSA."
16041072|NCT02588469|Other|Control group|Standard obesity care with physical activity program
16041073|NCT02588456|Biological|CART22 cells|CART22 cells transduced with a lentiviral vector to express anti-CD22 scFv TCRz:41BB administered by IV infusion.
16041074|NCT02588443|Drug|RO70097890|
16041075|NCT02588443|Drug|nab-paclitaxel|
16041076|NCT02588443|Drug|gemcitabine|
16041077|NCT02588417|Drug|Dexamethasone|4mg dexamethasone intrathecally plus levobupivacaine 2.5 mg
16041078|NCT02588417|Drug|Levobupivacaine|levobupivacaine 2.5 mg
16041079|NCT02588404|Drug|LHRH therapy|These patients will be treated with LHRH agonist as standard therapy.
16041080|NCT02588391|Behavioral|Brain Training (Active)|Online computer games targeting attention, EF, and problem-solving match the child's skill level.
16041081|NCT02588391|Behavioral|Brain Training (Passive)|Online computer games targeting attention, EF, and problem solving are set to a consistent level.
16041082|NCT02588391|Behavioral|Brain Training (Active or Passive)|Online computer games targeting attention, EF, and problem-solving either match the child's level or are set to a consistent level depending on which version the child has already completed.
16041083|NCT02588378|Procedure|multi-modal cSLO imaging|
16041084|NCT02588365|Behavioral|Brain Training (Active)|Online computer games targeting attention, EF, and problem-solving
16041085|NCT02588365|Behavioral|Brain Training (Passive)|Online computer games targeting attention, EF, and problem solving
16041086|NCT02588365|Behavioral|Brain Training (Active or Passive)|Online computer games targeting attention, EF, and problem solving
16041087|NCT02588352|Dietary Supplement|Salt tablet|Subjects will be given salt tablets and instructed to take 4 grams of sale three times a day (total of 12 grams of salt/day) for one week
16041122|NCT02588105|Drug|Fluorouracil|Module 2 combination with irinotecan/FOLFIRI
16041123|NCT02588105|Drug|Folinic Acid|Module 2 combination with irinotecan/FOLFIRI
16041124|NCT02588092|Drug|ADCT-301|Intravenous infusion
16041088|NCT02588339|Drug|Panobinostat|Panobinostat (PANO) will begin 5 days (Day -5) before transplant day (Day 0). All participants will take PANO by mouth once a day, three times a week (48 hours apart), every week for 26 weeks (approximately 6 months). PANO will be provided by Novartis as 5-mg pink gelatin capsules.
16041089|NCT02588339|Drug|Sirolimus|Sirolimus will be given the day before transplant and continued daily for at least one year. SIR will be administered starting on day -1 and thereafter. Dosing will be adjusted to maintain therapeutic targets per Moffitt institutional standards.
16041090|NCT02588339|Drug|Tacrolimus|Tacrolimus as an infusion or as a pill will begin 3 days before transplant (day -3) and following Moffitt institutional guidelines for dosing. Tacrolimus will be given for at least 50 days and participants will remain on Tacrolimus for as long as it is necessary per standard of care.
16041091|NCT02588326|Drug|Mometasone furoate drug formulation (MFF) 1|Mometasone furoate drug formulation (MFF) 1 will be administered by suspension-based nasal spray.
16041092|NCT02588326|Drug|Mometasone furoate drug formulation (MFF) 2|Mometasone furoate drug formulation (MFF) 2 will be administered by suspension-based nasal spray.
16041093|NCT02588313|Dietary Supplement|Mango fruit powder|Investigation of long-term effects of CarelessTM on microcirculation in healthy volunteers - a randomized, double-blind, placebo-controlled study with parallel design
16041094|NCT02588300|Procedure|Drug induced sleep endoscopy|Titration of propofol using a target controlled Infusion pump and description of the upper airway according to the VOTE classification
16041095|NCT02588287|Other|Blood draws for tenofovir PK, renal function|
16041096|NCT02588274|Device|Acupuncture|Acupuncture is one of the oldest standardized neuromodulatory therapies. The method of acupuncture treatment involves the insertion of needles in acupuncture points according to a system of channels and meridians. The needles are stimulated by manual manipulation, electrical stimulation or heat. The general theory of acupuncture is based on the premise that there are patterns of energy flow through the body that are essential for health. Disruptions of this flow are believed to be responsible for disease. Acupuncture may correct imbalances of flow at identifiable points close to the skin.
16041097|NCT02588274|Device|placebo needle|Placebo needle is a type of control without skin penetration based on the application of placebo needles with blunt needle tips.
16041098|NCT02588261|Drug|naquotinib mesilate|Participants received ASP8273 300 mg orally once daily on an empty stomach (no food for at least 2 hours before and 1 hour after taking drug) at approximately the same time every day.
16041099|NCT02588261|Drug|Erlotinib|Participants received erlotinib 150 mg orally once daily on an empty stomach (no food for at least 2 hours before and 1 hour after taking drug) at approximately the same time every day. At the beginning of the trial, prior to site initiation and shipment of study drug supplies, each investigator selected either erlotinib or gefitinib to be utilized for all participants randomized to the comparator arm at their site.
16041100|NCT02588261|Drug|Gefitinib|Participants received gefitinib 250 mg was taken orally once daily with water, with or without food, at approximately the same time every day. At the beginning of the trial, prior to site initiation and shipment of study drug supplies, each investigator selected either erlotinib or gefitinib to be utilized for all participants randomized to the comparator arm at their site.
16041101|NCT02588248|Drug|Peppermint Oil|During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640mg Placebo).
16041102|NCT02588248|Other|Placebo|During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640mg Placebo).
16041103|NCT02588235|Drug|Ezetimibe and Atorvastatin|atorvastatin (20 mg/day）plus ezetimibe（10 mg/day）
16041104|NCT02588235|Drug|Atorvastatin|atorvastatin (20 mg/day）
16041105|NCT02588209|Behavioral|Strategic Memory Advanced Reasoning Training|SMART teaches strategies to improve the ability to process information.
16041106|NCT02588209|Behavioral|Brain Health Workshop|Brain Health Workshop provides information about brain health in a seminar format. Topics include: sleep, nutrition, and exercise.
16041107|NCT02588196|Drug|Dexamethasone acetate|
16041108|NCT02588183|Device|ArticFont Advance ST Cryoenergy Balloon Catheter|PV isolation using the ArticFont Advance ST Cryoenergy Balloon Catheter
16041109|NCT02588170|Drug|Surufatinib|Surufatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle
16041110|NCT02588170|Other|Placebo|Placebo 300 mg once a day (QD) will be orally administrated on a 28-day cycle
16041111|NCT02588157|Device|Macintosh|Direct laryngoscopy
16041112|NCT02588157|Device|Glidescope|Glidescope videolaryngoscope
16041113|NCT02588157|Device|McGrath MAC X-Blade|McGrath MAC X-Blade videolaryngoscope
16041114|NCT02588144|Procedure|[standard STN]|High frequency deep brain stimulation with variable (best individual) stimulation on subthalamic contacts
16041115|NCT02588144|Procedure|[STN+SNr]|high frequency deep brain stimulation of combined (best individual) subthalamic and nigral stimulation
16041116|NCT02588131|Drug|tremelimumab plus MEDI4736|tremelimumab1 mg/kg i.v over 60 minutes plus MEDI 4736 20 mg/kg i.v every four weeks for 4 doses, then MEDI4736 20 mg/kg IV every four weeks for additional 9 doses.
16041117|NCT02588118|Drug|propofol|Propofol 2 mg/kg (t0) followed by cisatracurium 0.1 mg/kg 1 min (t2). Patients will be monitored using bispectral index monitoring for propofol and Relaxometer mechanomyograph neuromuscular monitoring for cisatracurium. Serial arterial blood samples (5 ml) were withdrawn in EDTA-tubes before cisatracurium administration, 1, 3, 5, 7, 10, 13, 16, 19, 22, 25, 30, 60 and 90 min following administration. Blood samples were assayed in duplicate using high performance liquid chromatograph for Pharmacokinetic analysis.
16041118|NCT02588118|Drug|Cisatracurium|Propofol 2 mg/kg (t0) followed by cisatracurium 0.1 mg/kg 1 min (t2). Patients will be monitored using bispectral index monitoring for propofol and Relaxometer mechanomyograph neuromuscular monitoring for cisatracurium. Serial arterial blood samples (5 ml) were withdrawn in EDTA-tubes before cisatracurium administration, 1, 3, 5, 7, 10, 13, 16, 19, 22, 25, 30, 60 and 90 min following administration. Blood samples were assayed in duplicate using high performance liquid chromatograph for Pharmacokinetic analysis.
16041119|NCT02588105|Drug|AZD0156|All patients will receive AZD0156 as a monotherapy or in combination to assess safety and tolerability.
16041126|NCT02588066|Procedure|Ligamentum teres/falciform-plasty|Ligamentum teres/falciform-plasty around the gastroduodenal artery stump during pancreatoduodenectomy
16041127|NCT02588040|Biological|Leukocyte- and Platelet-Rich Plasma (L-PRP)|The Recover L-PRP Mini Platelet Separation Kit aids in the separation of the patient's own blood components by density through the use of a Biomet Biologics centrifuge.
16041128|NCT02588027|Drug|Ibuprofen|Patients will be randomized using a computer generated number to received either ibuprofen (400mg by mouth every eight hours as needed) versus placebo for post-operative pain control in addition to opiate medication (hydrocodone/acetaminophen). Study doctors or research staff will be given randomly generated treatment allocations within sealed opaque envelopes. Once the patient is screened/qualified in surgery, the envelope will be opened and the patient randomized to the allocated treatment regimen. Patients will be given a two week supply (42 pills total) of either ibuprofen or placebo on the day of surgery upon discharge from the surgery center by a research coordinator.
16041129|NCT02588027|Drug|Placebo|Pharmacy formulated placebo
16041130|NCT02588014|Other|Magnetoencephalography|Magnetoencephalography is a non-invasive technique for investigating human brain activity. It allows the measurement of ongoing brain activity on a millisecond-by-millisecond basis, and it shows where in the brain activity is produced.
16041131|NCT02588001|Drug|Enzalutamide|All patients will receive enzalutamide 160 mg (four 40 mg capsules) orally once daily. The treatment will be started at Visit 0 within one week after enrollment. Visit 1 is at 2 weeks after the treatment started; clinical assessments are conducted on adverse events and the Japanese version of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) scales. Patients who are considered to be adequate by the investigator can continue the treatment with 12-week cycle visit (counted from initial dose) until patients meet withdrawal criteria. Patients will be followed up at 2 and 3 years after enrollment and at 3 years after the last participant enrollment.
16041132|NCT02587988|Drug|HCP1302|
16041133|NCT02587988|Drug|HGP0904|
16041134|NCT02587988|Drug|Placebo (for HCP1302)|
16041135|NCT02587988|Drug|Placebo (for HGP0904)|
16041136|NCT02587975|Drug|Evogliptin|10 mg
16041137|NCT02587962|Drug|Birinapant|Birinapant intravenous (IV) on Days 1 and 8 of each 21-Day Cycle. The following escalating doses of birinapant to be studied: 5.6, 11, 17, and 22 mg/m2. In the expansion phase the assigned recommended phase two dose will be administered in all cohorts
16041138|NCT02587962|Drug|Pembrolizumab|200 mg pembrolizumab IV on Day 1 of each 21-Day Cycle
16041139|NCT02587936|Other|Collaborative Model of Primary care and Subspecialty care|Pieces will access Electronic Health Record for all patients receiving care at the participating sites to detect patients with a triad of chronic kidney disease, diabetes and hypertension, facilitate management and monitor outcomes. To maximize successful implementation of care, a Practice Facilitator will be at each site with standardized role training using a curriculum based on the Agency for Healthcare Research and Quality (AHRQ) Practice Facilitation Handbook. Specific interventions are maintaining BP less than 140/90 mmHg, use of angiotensin-converting-enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB), treatment with statins, aiming for glycosylated Hemoglobin (HgA1C) at the recommended target, and avoiding nephrotoxic medications. Additional interventions include chronic kidney disease education for Primary Care Providers (PCP) and patients using National Kidney Disease Education Program (NKDEP) materials.
16041140|NCT02587910|Dietary Supplement|Melanole for GERD treatment|Melanole is given orally as 2 capsules TID 5 minutes before each meal
16041141|NCT02587910|Dietary Supplement|Placebo|Placebo is given orally as 2 capsules TID 5 minutes before each meal
16041142|NCT02587897|Other|Academic Coursework|Didactic training provided by the university through coursework and laboratory training that meets requirements of the accreditation standards provided by the professional society associated with each professional degree granting program.
16041143|NCT02587897|Other|Work-Related Hand Activities|Exposure to intensive training in the use of dental scaling tools as part of laboratory courses, as well as fieldwork and residency training during the academic degree program.
16041144|NCT02587884|Procedure|TACE|Patients will treated by TACE in 4 or 8 weeks after operation.
16041145|NCT02587871|Drug|Cytarabine|Given IV
16041146|NCT02587871|Other|Laboratory Biomarker Analysis|Correlative studies
16041147|NCT02587871|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo microtransplant
16041148|NCT02587871|Biological|Therapeutic Allogeneic Lymphocytes|Undergo microtransplant
16041149|NCT02587871|Biological|G-CSF mobilized peripheral blood cells|microtransplantation
16041150|NCT02587845|Drug|Tranexamic Acid (IV)|IV tranexamic acid group were administered intravenous 10 mg/kg dose of TXA after closing the ITB.
16041151|NCT02587845|Drug|Tranexamic Acid (Topical)|Topical tranexamic acid group were administered 2.0 g TXA in 100 ml of normal saline into the hemovac line after closing the ITB.
16041152|NCT02587832|Device|HHHFNC|Tri-Anim Vaptherm the Precision Flow, which is a self contained unit that provides flow rates up to or 8 LPM (Infants) of blended oxygen that is heated and humidified
16041153|NCT02587832|Device|NCPAP|Bubble CPAP System.
16041154|NCT02587819|Drug|Treatment with BSCT|"The study product BSCT (anti-nf-P2X7) 10% Ointment was anti-nf-P2X7 (highly purified sheep IgG) in an ointment formulation for topical administration. The formulation contained 10% weight by weight of the active pharmaceutical ingredient in an anhydrous ointment base.
~Fifty (50) to 100 mg of product (an amount the size of a small pea) was applied topically twice a day for 28 days to a 25 cm2 area of skin containing a single BCC lesion. The product was to be applied in the morning and in the evening after washing."
16041155|NCT02587806|Biological|Autologous Bone Marrow-Derived Mononuclear Stem Cells|Super selective intravenous administration of 50 million Autologous Bone Marrow-Derived Mononuclear Stem Cells (BM-MNC) and intrathecal administration of BM-MNCs in dose of 100 million along with liberation therapy (when associated with CCSVI)
16041156|NCT02587806|Other|Liberation therapy|
16041157|NCT02587793|Other|not interventional study|
16041158|NCT02587767|Device|577-MPL|All treatments were provided by a single practitioner with the 577-nm yellow laser system(Supra 577nm LaserSystem) in 577-MPL arm. The individual power for the patient was titrated at a normal area of near the affected area in micropulse model.The power titration was started at 700 milliwatt(mW) and then gradually increased until a just visible burn was seen. When this threshold was reached, the power was reduced by 50%, using a 100-μm spot diameter and a 200-ms duration with 5 % duty cycle.
16041159|NCT02587767|Device|HD-PDT|5 minutes after the start of the half-dose verteporfin infusion, the PDT treatment will been performed in HD-PDT arm. The treatment is performed with standard fluency (50 J/cm2), a PDT laser wavelength of 689 nm, and a standard treatment duration of 83 seconds.
16041160|NCT02587754|Device|Acupuncture|10 sessions of acupuncture, twice a week over 5 weeks.
16041161|NCT02587741|Drug|Metformin|start with metformin，from 500mg bid,if metformin reach the biggest dosage，added gliclazide modified release tablets，afterthat，add acarbose
16041162|NCT02587741|Drug|Lantus|started with insulin glargine 0.2 u/kg subcutaneous injection ，add dosage if glucose dose not reach the target.after that,you can add oral drugs（like oral drug group）
16041163|NCT02587741|Drug|Novomix30|started with premixed insulin subcutaneous injection(0.4-0.6 u/kg divided into half before breakfast and dinner),and add dosage if glucose dose not reach the target.after that,you can add oral drugs ,as Group Oral Drugs
16041164|NCT02587715|Biological|Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells|Super selective intravenous administration of 50 million Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells (UC-MSC) and intrathecal administration of UC-MSCs in dose of 100 million along with liberation therapy (when associated with CCSVI)
16041165|NCT02587715|Other|Liberation therapy|
16041166|NCT02587702|Other|β-Palmitate Content|
16041167|NCT02587702|Other|Placebo|
16041168|NCT02587702|Other|β-Palmitate Content Naturely in Human Milk|
16041169|NCT02587689|Biological|anti-MUC1 CAR T Cells|
16041170|NCT02587676|Other|Evatouch Super|The deterioration of RDLs may differ between in vitro conditions and the conditions encountered in denture wearers. We conducted an in vivo study to investigate how resilient denture liners (RDLs) changed in hardness when embedded in complete maxillary dentures worn by patients for one month in a clinical setting. We hypothesized that the hardness one month after application of the RDLs would be affected by the age, the condition of the saliva, the occlusal force, type of denture used, the patients habits related to smoking, drinking, wearing dentures while sleeping, and using a denture cleanser.
16041171|NCT02587663|Procedure|Contrast-enhanced Magnetic Resonance Imaging|Undergo bilateral breast contrast enhanced MRI
16041172|NCT02587663|Procedure|Mammography|Undergo bilateral mammography
16041173|NCT02587663|Procedure|Therapeutic Conventional Surgery|Undergo breast conserving surgery
16041174|NCT02587663|Procedure|Ultrasonography|Undergo bilateral whole-breast ultrasound
16041175|NCT02587663|Procedure|Ultrasonography|Undergo targeted breast ultrasound
16041176|NCT02587663|Other|Gadolinium|Contrast agent used in MRI
16041177|NCT02587650|Drug|Capmatinib|Given PO
16041178|NCT02587650|Drug|Ceritinib|Given PO
16041179|NCT02587650|Drug|Entrectinib|Given PO
16041180|NCT02587650|Other|Laboratory Biomarker Analysis|Correlative studies
16041181|NCT02587650|Drug|Regorafenib|Given PO
16041182|NCT02587637|Device|Dorsal Root Ganglion Stimulation|
16041183|NCT02587624|Procedure|catheter ablation|Intervention: All patients undergo magnetically guided pulmonary vein antral isolation and mapping for fibrotic areas. Procedural endpoint: bidirectional PV block. Additional substrate modification on decision of the operator.
16041184|NCT02587611|Other|Elemental liquid diet|This is a randomized, crossover trial. Two types of test meals (200 kcal/200 mL of either the elemental diet or the semi-solid diet) are labeled with 100 mg [13C]sodium acetate and administered within 5 min in healthy subjects or within 15 min in gastrostomy-fed patients.
16041185|NCT02587611|Other|Standard semi-solid diet|This is a randomized, crossover trial. Two types of test meals (200 kcal/200 mL of either the elemental diet or the semi-solid diet) are labeled with 100 mg [13C]sodium acetate and administered within 5 min in healthy subjects or within 15 min in gastrostomy-fed patients.
16041186|NCT02587598|Drug|INCB053914|"Initial cohort dose of INCB053914 at the protocol-specified starting dose in two treatment groups in dose escalation, with subsequent expansion in up to five cohorts based on protocol-specific criteria.
~INCB053914 tablets to be administered by mouth."
16041187|NCT02587598|Drug|INCB053914|Initial cohort dose of INCB053914 at the protocol-specified starting dose. INCB053914 tablets to be administered by mouth.
16041188|NCT02587598|Drug|I-DAC (Intermediate dose cytarabine)|Cytarabine dose will be 1 g/m^2. Cytarabine will be administered as an intravenous (IV) infusion.
16041189|NCT02587598|Drug|Azacitidine|Azacitidine dose will be 75 mg/m^2. Azacitidine will be administered either sub-cutaneously (SC) or intravenously (IV).
16041190|NCT02587598|Drug|Ruxolitinib|Starting dose of ruxolitinib will be the dose the subject was on at study entry Ruxolitinib will be administered by mouth.
16041191|NCT02587585|Behavioral|Feedback against tailored target|Participants will wear a smart watch every weekday for nine hours during in-patient rehabilitation to monitor activity levels while receiving their usual care. In the active group, the watch will summate activity movement in two hour epochs and the target for the day for that epoch is the activity in the same epoch 24 hours earlier, plus 5%. During an epoch the patient is shown progress towards the target at at the end of an epoch, they will see their final process towards target for that epoch.
16041192|NCT02587585|Behavioral|No feedback|Participants will wear a smart watch every weekday for nine hours during in-patient rehabilitation to monitor activity levels while receiving their usual care. However the watch face will simply show which epoch a person is in. The watch will collect the activity in exactly the same way over the day.
16041193|NCT02587572|Biological|Peripheral Intravenous (IV) infusion of LMSCs|Peripheral Intravenous (IV) infusion of LMSCs
16041194|NCT02587559|Procedure|physical therapy|application of manual therapy techniques to upper extremity along with therapeutic exercise procedures to the axioscapular and rotator cuff musculature
16041195|NCT02587546|Procedure|laryngeal carcinoma|treatment of laryngeal carcinoma using thulium contact laser
16041196|NCT02587546|Procedure|bilateral vocal cord paralysis|treatment of bilateral vocal cord paralysis using thulium contact laser
16041197|NCT02587546|Procedure|subglottic stenosis|treatment of subglottic stenosis using thulium contact laser
16041198|NCT02587533|Other|Hypoxia without dopamine|Target hemoglobin oxygen saturation (SpO2) 80%.
16041199|NCT02587533|Other|Hypoxia with dopamine|Target hemoglobin oxygen saturation (SpO2) 80%. Dopamine dose 3 µg/kg/min.
16041200|NCT02587533|Other|Hyperoxia without dopamine|Nearly complete hemoglobin oxygen saturation.
16041201|NCT02587533|Other|Hyperoxia with dopamine|Nearly complete hemoglobin oxygen saturation. Dopamine dose 3 µg/kg/min.
16041202|NCT02587520|Biological|Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed Formulation 1|0.5 milliliter (mL), Intramuscular
16041203|NCT02587520|Biological|Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 2|0.5 mL, Intramuscular
16041204|NCT02587520|Biological|Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 3|0.5 mL, Intramuscular
16041205|NCT02587520|Biological|Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed, Formulation 4|0.5 mL, Intramuscular
16041206|NCT02587520|Biological|Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine Adsorbed|0.5 mL, Intramuscular
16041207|NCT02587520|Biological|Licensed Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine|0.5 mL, Intramuscular
16041208|NCT02587507|Other|Orange juice|Individuals will consume the HFHC meal with 500mL of orange juice.
16041209|NCT02587507|Other|Water|Individuals will consume the HFHC meal with 500mL of water.
16041210|NCT02587507|Other|Water with glucose|Individuals will consume the HFHC meal with 500mL of water with glucose.
16041211|NCT02587494|Procedure|Cardiac catheterization|Cardiac catheterization / coronary angiography is a diagnostic procedure used to define the coronary anatomy and presence of obstructive coronary lesions or culprit lesions. According to the findings, it may lead to percutaneous coronary intervention (PCI) using stents
16041212|NCT02587468|Dietary Supplement|Juice Plus+(R)|before-after comparison of plasma phenolics
16041213|NCT02587455|Drug|Pembrolizumab|Pembrolizumab - Trial Treatment
16041214|NCT02587455|Radiation|Radiotherapy|Radiotherapy - Standard Treatment
16041215|NCT02587442|Drug|RadProtect®|This study will evaluate RadProtect® at sequential, escalating dose levels. Once administration is given, study subjects will be followed during 24 hours of hospitalization according to the final injection timing. All subjects will need to return to the hospital for monitoring at 7+2 days after dosing, and follow-up visits by telephone at Day 3, Day 14+2, and Day 28+2 days will need to be conducted.
16041216|NCT02587429|Behavioral|Patient education|
16041217|NCT02587416|Drug|Gemcabene 300 mg|1x300 mg gemcabene tablets orally once daily (QD) for 11 days
16041218|NCT02587416|Drug|Gemcabene 900 mg|3x300 mg Gemcabene tablets orally once daily (QD) for 11 days
16041219|NCT02587416|Drug|Atorvastatin|2x40 mg Atorvastatin tablets orally once daily (QD)
16041220|NCT02587403|Device|Fortiva™ Porcine Dermis|Fortiva Porcine Dermis implantation during repair of complex ventral hernia
16041221|NCT02587403|Device|Strattice™ Reconstructive Tissue Matrix|Strattice tissue matrix implanted during repair of complex ventral hernia
16041222|NCT02587390|Drug|Gemcabene 900 mg|3x300 mg Gemcabene tablets orally once daily (QD) for 15 days
16041223|NCT02587390|Drug|Simvastatin 80 mg|2x40 mg Simvastatin tablets orally once daily (QD) for 15 days
16041224|NCT02587377|Other|Non Standard of Care blood samples collection|According to Belgian Law of 07MAY2004, if non standard of care interventions are performed as per protocol, the study must be classified as Interventional Study.
16041225|NCT02587364|Drug|Gemcabene 50 mg|Gemcabene 50 mg once daily (QD)
16041226|NCT02587364|Drug|Gemcabene 150 mg|Gemcabene 150 mg once daily (QD)
16041227|NCT02587364|Drug|Gemcabene 450 mg|Gemcabene 450 mg once daily (QD)
16041228|NCT02587364|Drug|Gemcabene 750/600 mg|Gemcabene 750/600 mg once daily (QD)
16041229|NCT02587364|Drug|Gemcabene 900 mg|Gemcabene 900 mg once daily (QD)
16041230|NCT02587364|Drug|Placebo|Placebo once daily (QD)
16041231|NCT02587351|Drug|Metoprolol succinate|Extended release Metoprolol succinate
16041232|NCT02587351|Other|Placebo|Matching placebo
16041233|NCT02587338|Device|Verum tDCS|Neuropsychological (Working memory) training for 30 minutes, 6 sessions tDCS during training with 2000 microampere left anadal, right cathodal
16041234|NCT02587338|Device|Sham tDCS|Neuropsychological (Working memory) training for 30 minutes, 6 sessions tDCS during training with 0 microampere
16041235|NCT02587325|Drug|ABI-009, nab-rapamycin, albumin-bound rapamycin|ABI-009
16041236|NCT02587312|Other|Very low nicotine content cigarettes|
16041237|NCT02587312|Other|Standard nicotine content cigarettes|
16041238|NCT02587286|Other|Gather app|Participants in the intervention group will receive the Gather Health software free for the duration of the study. Their medication and BG testing goals will be entered into the system and they will receive automated reminders. Their data will be regularly reviewed by study staff and feedback provided.
16041239|NCT02587273|Drug|Fentanyl|In this study there will be no administration of an investigational product per study protocol. The dosage of fentanyl will be according to the ICU's established procedures and the treating physician's judgment. The specific dose of fentanyl given to each patient will differ extensively. By routine, the ICU's in our hospital usually dose the fentanyl infusion as 0,5 - 6 μg/kg/hrs (kg = Ideal Body Weight). The intervention in this study will be a per protocol cessation in administration of fentanyl over a 6 hours period. Arterial blood samples, urine samples, pre and post filter samples and samples from dialysate will be collected during this 6 hours. If the patient needs opioid analgesia during the period, alternative opioid analgesia will be given.
16041240|NCT02587260|Drug|Ticagrelor|Comparison of ticagrelor with respect to prasugrel and clopidogrel in a different sequence
16041241|NCT02587260|Drug|Prasugrel|Comparison of ticagrelor with respect to prasugrel and clopidogrel in a different sequence
16041242|NCT02587260|Drug|Clopidogrel|Comparison of ticagrelor with respect to prasugrel and clopidogrel in a different sequence
16041243|NCT02587247|Drug|TF2 antibody/68Ga-IMP-288|
16041244|NCT02587234|Device|peripheral nerve stimulation|Non-invasive stimulation of median, ulnar and radial nerves
16041245|NCT02587221|Biological|MF59-adjuvanted Quadrivalent Subunit Inactivated Egg-derived Influenza Vaccine (aQIV)|1 dose approximately 0.5 mL of aQIV
16041246|NCT02587221|Biological|Non-Influenza Comparator (Boostrix)|1 dose approximately 0.5 mL dose of Non-influenza comparator vaccine (Boostrix)
16041319|NCT02586675|Drug|Ribociclib|"Ribociclib (LEE011) will be taken orally once daily on days 1-21 of each 28 day cycle. Days 22-28 will be a rest period from dosing with Ribociclib. In the continuous cohort, 400 mg ribociclib will be given daily (QD)."
16044589|NCT02563847|Dietary Supplement|50 g Xylitol|
16041247|NCT02587208|Device|Plastibell|In the Plastibell group, the size of the device is chosen according to the lateral-lateral diameter of the glans. A dorsal slit incision is made and then the foreskin is pulled up and the Plastibell device placed between the prepuce and the glans. A non-absorbable string was tightly tied around the device and the distal prepuce is removed.
16041248|NCT02587208|Procedure|conventional sleeve|In the sleeve dissection group, a double incision technique on both outer and inner layers of the foreskin is employed. Hemostasis is achieved by bipolar diathermy, and cut edges are sutured with 5/0 rapide vicryl.
16041249|NCT02587195|Drug|Teriflunomide|
16041250|NCT02587182|Device|Deep Dry needling|The muscles were repeatedly perforated by rapidly inserting and partially withdrawing the needle from the myofascial trigger point, eliciting local twitch responses in some insertions
16041251|NCT02587169|Drug|Nilotinib-adriamycin|The nilotinib-adriamycin combination will be given in 4 cycles of 21 days. In each cycle, nilotinib will be administered at fixed dose of 400 mg/12h orally during 6 consecutive days (1-6) and endovenous adriamycin (20 minutes) on day 5 at three levels (in phase I, dosage of 60 mg/m2, 65 mg/m2, and 75 mg/m2 will be tested to determine the recommended dose for phase II).
16041252|NCT02587156|Dietary Supplement|Meal serving at high dietary protein|Participants are habituated to a high level of dietary protein intake for 21 days.
16041253|NCT02587156|Dietary Supplement|Meal serving at low dietary protein|Participants are habituated to a low level of dietary protein intake for 21 days.
16041254|NCT02587156|Dietary Supplement|Meal serving|To investigate impact of habituated protein level
16041255|NCT02587143|Drug|Ethyl chloride|Nurses will administrate ethyl chloride vapocoolant spray on patient's skin a few seconds before arterial puncture (of cubital arteria).
16041256|NCT02587143|Drug|Alcohol|Nurses will use an alcohol-based spray as placebo on patient's skin a few seconds before arterial puncture (of cubital arteria).
16041257|NCT02587130|Drug|Ketamine|ketamine administered in bolus by subcutaneous injection
16041258|NCT02587117|Drug|lycopene|Each capsule contain 2 mg lycopene. Each patient was received two capsules of lycopene (total dose was 4 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy.
16041259|NCT02587117|Drug|Prednisolone|Each capsule contain 20 mg prednisolone. Each patient was received two capsules of prednisolone (total dose was 40 mg) single dose in morning for 2 months. Follow-up was done at base line, 2nd, 4th, 6th and 8th weeks of the therapy.
16041260|NCT02587104|Other|EpiFix|Weekly application of EpiFix and standard of care (moist wound therapy and offloading)
16041261|NCT02587091|Behavioral|Portable obstetric ultrasound|This intervention was advertised at the cluster level
16041262|NCT02587078|Drug|Volulyte|Patients who meet the inclusion criteria (at Screening, see below for definition) will be randomized immediately in a ratio of 1:1 to either intravenous Volulyte® or Jonosteril® for fluid resuscitation (on RAND). Fluid resuscitation with study drug will be started immediately in order to reach initial hemodynamic stabilization.
16041263|NCT02587078|Drug|Jonosteril|Patients who meet the inclusion criteria (at Screening, see below for definition) will be randomized immediately in a ratio of 1:1 to either intravenous Volulyte® or Jonosteril® for fluid resuscitation (on RAND). Fluid resuscitation with study drug will be started immediately in order to reach initial hemodynamic stabilization.
16041264|NCT02587065|Drug|peginterferon beta-1a|125 mcg administered subcutaneously (SC) every 2 weeks.
16041265|NCT02587052|Drug|Generic tacrolimus|Generic tacrolimus
16041266|NCT02587052|Drug|Prograf|Prograf, the original tacrolimus
16041267|NCT02587039|Procedure|Remote ischemic pre-conditioning|Remote ischemic preconditioning is exposure to a brief period ischemia to an area or limb that is not involved in surgery. This intervention is believed to reduce the incidence of cerebral (brain) ischemia during cardiac surgery.
16041268|NCT02587039|Behavioral|Delirium Assessment|The Delirium assessment consist of a validated psychiatric screening tool called the Confusion Assessment Method. We will use this tool to determine if patients have any confusion after surgery.
16041269|NCT02587026|Other|Blood sample collection|
16041270|NCT02587026|Other|Tumor tissue sample collection|
16041271|NCT02587013|Procedure|Type A of uterine repair: In situ|The uterine incision is closed with the uterus within the abdominal cavity
16041272|NCT02587013|Procedure|Type B of uterine repair: Exteriorization|The uterine incision is repaired with the exteriorization of the uterus
16041273|NCT02587000|Drug|Ulipristal acetate|
16041274|NCT02587000|Drug|Placebo|
16041275|NCT02586987|Drug|Selumetinib|Selumetinib oral
16041276|NCT02586987|Drug|MEDI4736|MEDI4736 IV
16041277|NCT02586987|Drug|Tremelimumab|Tremelimumab, IV
16041278|NCT02586974|Device|Humigard|warmed and humidified CO2 insufflation
16041279|NCT02586961|Drug|0.9% saline solution|"Placebo:
~Nebulized 0.9% saline solution"
16041280|NCT02586961|Drug|oral betamethasone placebo|placebo of oral betamethasone: equivalent of 1 mg/kg at inclusion followed by five once-daily doses
16041281|NCT02586961|Drug|adrenaline|Catecholamine nebulized adrenaline (3 ml of 1:1000 solution)
16041282|NCT02586961|Drug|oral betamethasone|Mineralocorticoid: a short course of oral betamethasone: 1.0 mg/kg at inclusion, followed by five once-daily doses (0.6 mg/kg)
16041283|NCT02586948|Device|extracorporeal CO2 removal (Hemolung device)|ECCO2R in severe exacerbation of COPD patients, requiring invasive mechanical ventilation with persistent respiratory acidosis and dynamic hyperinflation
16041284|NCT02586935|Drug|Tideglusib|Administered orally after dispersion in approximately 100 ml of water at dose levels of 400 to 1000 mg
16041285|NCT02586935|Other|Placebo|Administered orally after dispersion in approximately 100 ml of water
16041286|NCT02586922|Device|Three-dimensional (3D) ultrasonography|A longitudinal section of fetal chest will be obtained that clearly depicts the lung. A 3D window will be activated . After complete electronic sweep and assurance of absence of fetal or maternal movements to avoid motion artifacts, 3D multi-planar view will be then obtained
16041287|NCT02586909|Drug|RVT-101 35 mg tablets|once daily, oral tablets
16041320|NCT02586675|Drug|Goserelin|Goserelin will be given as an injectable subcutaneous implant on day 1 of every 28 day cycle. This will be given in pre-menopausal and peri-menopausal women.
16041321|NCT02586649|Drug|Tiotropium Bromide|Tiotropium bromide is an anticholinergic used to study bronchodilatation and improvement of pulmonary function in tetraplegic patients
16041288|NCT02586896|Behavioral|Strengths-based Case Management (SBCM)|The six case management sessions for the proposed trial are based on those described in manuals developed by Dr. Rapp for two clinical trials, one supported by National Institute on Drug Abuse (NIDA) and another by the Centers for Disease Control (CDC). Each session is guided by specific objectives that promote linkage with and retention in substance abuse treatment, particularly pharmacotherapy for opioid dependence in a specialty or primary care setting. Objectives from the earlier trials will be adapted to fit the specific context of this trial, linking with and staying in treatment following an emergency department visit. Initiation of the relationship between client and case manager begins immediately following random assignment and termination takes place when either (1) six sessions have occurred; (2) ninety days have elapsed; or (3) clients discontinue involvement.
16041289|NCT02586896|Behavioral|Screening, Assessment, and Referral (SAR)|"The research assistant will provide these participants with an information sheet listing treatment (including both specialty treatment centers and primary care clinics that provide buprenorphine) and self-help resources in their community. The referral sheet includes names, addresses, and phone numbers of local addiction treatment agencies. Because the emergency department does not currently screen or refer systematically, the SAR condition represents a level of care significantly higher than treatment as usual. Participants will also receive an informational pamphlet about drug use and its consequences, addiction, and treatment."
16041290|NCT02586883|Other|bronchial ddp test|bronchial ddp test during endoscopy, nasal smear, bronchial smear
16041291|NCT02586870|Device|Intravascular Ultrasound|
16041293|NCT02586831|Drug|Anti-Thymocyte Globulin (ATG)|2.5 mg/kg administered as two divided infusions of 0.5 mg/kg and 2 mg/kg on Days 1 and 2.
16041294|NCT02586831|Drug|Interleukin 2|1 million IU per dose administered subcutaneously for 5 consecutive days on Days 10-14, and then every two weeks.
16041295|NCT02586831|Drug|Exenatide|2 mg administered subcutaneously weekly for up to 52 weeks.
16041296|NCT02586831|Drug|Adalimumab|50 mg administered subcutaneously once a month for 1 year.
16041297|NCT02586831|Other|ATG Placebo|ATG placebo mimicking Thymoglobulin administered intravenously.
16041298|NCT02586831|Other|IL-2 Placebo|IL-2 placebo mimicking Aldesleukin administered subcutaneously.
16041299|NCT02586831|Other|Adalimumab Placebo|Placebo mimicking Adalimumab administered subcutaneously.
16041300|NCT02586831|Other|Exenatide Placebo|Placebo mimicking Exenatide administered subcutaneously.
16041301|NCT02586805|Drug|DX-2930 - 300mg/2wk|300 mg DX-2930 administered every 2 weeks by subcutaneous injection.
16041302|NCT02586805|Drug|DX-2930 - 300mg/4wk|300 mg DX-2930 administered every 4 weeks by subcutaneous injection. To maintain the study blind, subjects will be given placebo injections every other 2 weeks when they are not receiving drug.
16041303|NCT02586805|Drug|DX-2930 - 150mg/4wk|150 mg DX-2930 administered every 4 weeks by subcutaneous injection. To maintain the study blind, subjects will be given placebo injections every other 2 weeks when they are not receiving drug.
16041304|NCT02586805|Drug|Placebo|Placebo administered every 2 weeks by subcutaneous injection.
16041305|NCT02586792|Biological|Monovalent influenza A/H7N9 virus vaccine|Monovalent influenza A/H7N9 virus vaccine.
16041306|NCT02586779|Other|whatsApp|whatsApp application will be used for consultations.
16041307|NCT02586779|Other|without whatsApp|whatsApp application will be not used for consultations.
16041308|NCT02586766|Behavioral|Project Sync|A 30 minute private on-on-one brief motivational interviewing intervention given during emergency department care. The goal of the intervention was to reduce and prevention youth violence using techniques to change behavior in a respectful, non-confrontational, and non-judgmental manner. This one-on one counseling approach emphasizes individual choice and responsibility and differentiates between future goals/values and current behavior
16041309|NCT02586753|Other|Paclitaxel plus Cisplatin with radiotherapy|"we want to compare which regime is better with radiotherapy, PT regime (paclitaxel and cisplatine ) Chemotherapy: Patients will be concurrently administered with irradiation every 3 weeks with PT regimen (cisplatin of 20 mg/m2/d, d1-3; PTX(paclitaxel)of 135mg/m2/d, d1) for 4 cycles. For the first 2-cycles of chemotherapy they will be concurrently given with irradiation and the remained 2 cycles, after irradiation.
~Radiotherapy:Patients will be conducted CT simulation, and Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator."
16041310|NCT02586753|Other|S1 plus Cisplatin with radiotherapy|"we want to compare which regime is better with radiotherapy,SP regime (Tegafur Gimeracil Oteracil Potassium Capsule and cisplatine).
~Chemotherapy: Patients will be concurrently administered with irradiation every 3 weeks with PS regimen (cisplatin of 20 mg/m2/d, d1-3; S1(Tegafur Gimeracil Oteracil Potassium Capsule)of 50mg/m2/d, d1-14) for 4 cycles. For the first 2-cycles of chemotherapy they will be concurrently given with irradiation and the remained 2 cycles, after irradiation.
~Radiotherapy:Patients will be conducted CT simulation, and Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator."
16041311|NCT02586740|Procedure|Pulmonary artery rehabilitation|
16041312|NCT02586727|Drug|aflibercept|This study will consist of 2 simultaneous treatment arms of aflibercept: A six week dosing regimen arm and a treat and extend (TAE) dosing regimen arm, total duration 54 weeks. In the TAE arm the patients will receive an intravitreal aflibercept injection first visit, again at the second visit at 6 weeks, and then begin treat and extend from second injection forward.
16041313|NCT02586714|Other|No intervention|Observation only
16041314|NCT02586701|Other|Prehabilitation Plus|Supervised exercise program and home-based exercise program.
16041315|NCT02586688|Device|Active NeuroStar® Transcranial Magnetic Stimulation (TMS)|Compare active NeuroStar® coil with sham NeuroStar® coil.
16041316|NCT02586688|Device|Sham NeuroStar® Transcranial Magnetic Stimulation (TMS)|Compare active NeuroStar® coil with sham NeuroStar® coil.
16041317|NCT02586688|Device|Open Label Active NeuroStar® TMS|Open label NeuroStar® coil.
16041318|NCT02586675|Drug|Tamoxifen|Tamoxifen will be taken orally once daily on a continuous daily schedule (e.g., days 1-28 of each 28 day cycle).
16041322|NCT02586649|Drug|Placebo|Placebo is a non-active inhalation capsule .
16044590|NCT02563847|Dietary Supplement|75 g Erythritol|
16041323|NCT02586636|Drug|Metformin|Metformin is given alongside omeprazole / placebo. Started at low dose and titrated gradually over four weeks according to the individual's tolerance of metformin. We anticipate that their tolerance of metformin will be reduced by loss of function variants in OCT1, and by concurrent use of OCT1 inhibiting drugs (in our study this is omeprazole).
16041324|NCT02586636|Drug|Omeprazole|Given as concurrent treatment in one of the two treatment periods. Omeprazole treatment dose is fixed at 20mg twice daily for four weeks duration. Omeprazole, in our study, is used as an OCT1 inhibitor, and we hypothesise that this will reduce an individual's maximum tolerated dose of metformin during concurrent treatment. This will be compared to the other treatment period in which concurrent treatment is a placebo, and therefore, the maximum tolerated dose of metformin would not be affected.
16041325|NCT02586636|Drug|Placebo|Given as concurrent treatment in one of the two treatment periods. Placebo treatment dose is fixed at one tablet twice daily (to match the dosing pattern of omeprazole) for four weeks duration. Omeprazole, in our study, is used as an OCT1 inhibitor, and we hypothesise that this will reduce an individual's maximum tolerated dose of metformin during concurrent treatment. This will be compared to the other treatment period in which concurrent treatment is a placebo, and therefore, the maximum tolerated dose of metformin would not be affected.
16041326|NCT02586623|Drug|Droxidopa capsules|100, 200 or 300 mg
16041327|NCT02586623|Drug|Placebo capsules|
16041328|NCT02586610|Drug|Pembrolizumab|Pembrolizumab 200 mg IV Days 1, 22 and 43
16041329|NCT02586610|Drug|Capecitabine|Capecitabine 825 mg/m2 PO twice a day (daily total 1650 mg/m2) on 5 consecutive days / week M-F given on the radiation days for 28 days
16041330|NCT02586610|Radiation|Radiation Therapy|Radiation 50.4 GY in daily fractions of 1.8 Gy over a 6 week interval (excludes weekends)
16041331|NCT02586597|Device|Transcranial magnetic stimulation & median nerve stimulation|"Paired associative stimulation (PAS) is a new technique where one pairs a peripheral stimulation with centrally applied transcranial magnetic stimulation (TMS), and produces plasticity, as measured by TMS MEP's. Currently PAS is performed with median nerve stimulation.
~PA25: The interval between median nerve stimulation and TMS was chosen to be 25 ms, which is called PAS25. 240 paired TMS and median nerve stimulation at a frequency of 0.2 Hz over 20 min.
~PAS10: 240 paired TMS and median nerve stimulation with interval of 10 min second at a frequency of 0.2 Hz over 20 min.
~PAS100: 240 paired TMS and median nerve stimulation with interval of 100 min second at a frequency of 0.2 Hz over 20 min."
16041332|NCT02586571|Behavioral|Breastfeeding|Breastfeeding at 5.5 months of age (exclusive or partial)
16041333|NCT02586558|Other|Experimental Infant formula|Ready-to-feed infant formula to be fed ad libitum
16041334|NCT02586558|Other|Reference group|Ready-to-feed infant formula to be fed ad libitum
16041335|NCT02586545|Other|Shared care|
16041336|NCT02586519|Device|SurroSense Rx System|"The SurroSense Rx system (Orpyx Medical Technologies Inc., Calgary, AB) is a smart insole system designed to aid in the prevention of plantar pressure ulceration and re-ulceration, and the treatment of active ulcers in neuropathic patients. It comprises two pressure-sensing inserts and a smartwatch display device. The device alerts the user when safe pressure and time thresholds have been exceeded so that on-demand offloading can occur."
16041337|NCT02586506|Drug|Placebo ELLIPTA inhaler|The ELLIPTA Dry Powder Inhaler (DPI) is a molded plastic two-sided inhaler that can hold two individual blister strips. Each strip will contain either lactose or a blend of lactose and magnesium stearate. Subjects will receive 1 inhalation once-daily until visit 2.
16041338|NCT02586506|Other|Questionnaire|ELLIPTA Inhaler Ease of Use Questionnaire is a four-point Likert scale. This questionnaire will be filled by investigator (designee) based on responses received from subject. Responses for the questionnaire are Very difficult, Difficult, Easy, Very easy. Subjects will be give either version A or B at Visit 2.
16041339|NCT02586493|Drug|Placebo|Subjects will receive 1 inhalation once-daily until visit 2.
16041340|NCT02586493|Other|Questionnaire|ELLIPTA Inhaler Ease of Use Questionnaire is a four-point Likert scale. This questionnaire will be filled by investigator (designee) based on responses received from subject. Responses for the questionnaire are Very difficult, Difficult, Easy, Very easy. Subjects will be give either version A or B at Visit 2.
16041341|NCT02586480|Device|dual chamber pacemaker with SafeR algorithm|SafeR is an AVB management algorithm: it provides AAI pacing while continuously monitoring AV conduction, it switches to DDD when detecting AVB I, II or III, according to the following criteria: (1) AVB I: 6 long PR intervals, (2) AVB II: 3 blocked atrial events/12 cycles, (3) AVB III: 2 consecutive blocked atrial events. It switches back to AAI mode when needed.
16041342|NCT02586467|Behavioral|Gain-Framed|Participants will be randomised to one of five message conditions. Each condition will receive a total of four emailed messages on four consecutive days (i.e., 1 message per day). Participants in the Gain-Framed message condition will receive message content that highlights the potential benefits of consuming milk and milk products (i.e., high protein content, stronger hair and nail etc.)
16041343|NCT02586467|Behavioral|Loss-Framed|Participants will be randomised to one of five message conditions. Each condition will receive a total of four emailed messages on four consecutive days (i.e., 1 message per day). Participants in the Loss-Framed message condition will receive message content that highlights the potential losses of not consuming milk and milk products (i.e., lack of essential nutrients, less calcium).
16041344|NCT02586467|Behavioral|Self-Regulatory Efficacy|Participants will be randomised to one of five message conditions. Each condition will receive a total of four emailed messages on four consecutive days (i.e., 1 message per day). Participants in the Self-Regulatory Efficacy message condition will receive information pertaining to how to include milk and milk products within their diet. This information will come in the form of recipes, meal planning, food combining etc.
16041345|NCT02586467|Behavioral|Gain-Framed + Self-Regulatory Efficacy|Participants will be randomised to one of five message conditions. Each condition will receive a total of four emailed messages on four consecutive days (i.e., 1 message per day). Participants in the Gain-Framed message + Self-Regulatory Efficacy condition will receive message content that highlights the potential benefits of consuming milk and milk products (i.e., high protein content, stronger hair and nail etc.) and information pertaining to how to include milk and milk products within their diet.
16041397|NCT02586155|Drug|Atorvastatin|High-Intensity Statin
16041398|NCT02586155|Drug|Rosuvastatin|High-Intensity Statin
16041399|NCT02586142|Drug|Botulinum Toxin Type A|To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by ultrasounds guidance.
16041346|NCT02586467|Behavioral|Loss-Framed + Self-Regulatory Efficacy|Participants will be randomised to one of five message conditions. Each condition will receive a total of four emailed messages on four consecutive days (i.e., 1 message per day). Participants in the Loss-Framed message + Self-Regulatory Efficacy condition will receive message content that highlights the potential losses of not consuming milk and milk products (i.e., lack of essential nutrients, less calcium) and information pertaining to how to include milk and milk products within their diet.
16041347|NCT02586454|Procedure|Transmuscular quadratus lumborum block|
16041348|NCT02586454|Drug|morphine|
16041349|NCT02586454|Drug|ropivacaine|
16041350|NCT02586441|Device|Electroencephalography|Raw EEG signals were acquired at a sampling rate of 128Hz using a BIS-VISTATM monitor and was measured during all anesthetic period.
16041351|NCT02586441|Drug|Propofol|intravenous 1% propofol (1.5-2.5 mg/kg)
16041352|NCT02586441|Drug|Rocuronium bromide|intravenous rocuronium bromide (0.6 mg/kg)
16041353|NCT02586428|Other|what patients elect noninvasive prenatal testing (NIPT)|what percentages of patients elect noninvasive prenatal testing (NIPT), amniocentesis, or no testing before and after genetic counseling.
16041354|NCT02586415|Procedure|Endovascular Thrombectomy|Patients will be treated with thrombectomy devices (stent-retrievers) and/or suction thrombectomy systems currently cleared by the FDA for thrombus removal in patients experiencing an acute stroke following the published instructions for use for these devices. These devices will be used between 6 and 16 hours following symptom onset in DEFUSE 3 based on an FDA IDE. The devices which will be used are the Trevo Retriever, the Solitaire Revascularization Device and the Penumbra system thrombectomy system.
16041355|NCT02586415|Device|Trevo Retriever|Trevo Retriever is one of the interventional devices that is approved for use in DEFUSE 3 during the endovascular thrombectomy procedure. The device choice is at the discretion of the physician performing the procedure.
16041356|NCT02586415|Device|Solitaire™ FR Revascularization Device|Solitaire™ FR Revascularization Device is one of the interventional devices that is approved for use in DEFUSE 3 during the endovascular thrombectomy procedure. The device choice is at the discretion of the physician performing the procedure.
16041357|NCT02586415|Device|Penumbra thrombectomy system|"Penumbra thrombectomy system is one of the interventional devices that is approved for use in DEFUSE 3 during the endovascular thrombectomy procedure. The device choice is at the discretion of the physician performing the procedure. The Penumbra System includes:
~• Penumbra Aspiration Pump (1115V) Penumbra System 054 Penumbra System MAX Penumbra System 110 Aspiration Tubing Penumbra System [026, 032, 041] Penumbra System Separator Flex [026, 032, 041, 054] Penumbra Pump MAX Penumbra System Reperfusion Catheter ACE64 & ACE68"
16041358|NCT02586415|Device|Covidien MindFrame Capture Revascularization Device|Covidien MindFrame Capture Revascularization Device is one of the interventional devices that is approved for use in DEFUSE 3 during the endovascular thrombectomy procedure. The device choice is at the discretion of the physician performing the procedure.
16041359|NCT02586402|Drug|pegol-Sihematide|
16041360|NCT02586402|Drug|Epoetin Alfa|
16041361|NCT02586376|Device|0J LLLT|Sham Low-Level Laser Therapy (Sham LLLT): perform with the machine off.
16041362|NCT02586376|Device|4J LLLT|4J Low-Level Laser Therapy (4J LLLT) irradiation will be perform with 4J.
16041363|NCT02586376|Device|6J LLLT|6J Low-Level Laser Therapy (6J LLLT) irradiation will be perform with 6J.
16041364|NCT02586376|Device|8J LLLT|8J Low-Level Laser Therapy (8J LLLT) irradiation will be perform with 8J.
16041365|NCT02586363|Drug|Baraclude Tab. 0.5mg, fasting|After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration)
16041366|NCT02586363|Drug|Cavir Tab. 0.5mg, fasting|After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration)
16041367|NCT02586363|Drug|Cavir Tab. 0.5mg, high fatty meal|After drug administration, Blood sampling for Pharmacokinetics (Entecavir concentration)
16041368|NCT02586350|Drug|Anlotinib|
16041369|NCT02586350|Drug|Placebo|Placebo p.o. qd
16041370|NCT02586337|Drug|Anlotinib|Anlotinib p.o. qd
16041371|NCT02586337|Drug|Placebo|Placebo p.o. qd
16041372|NCT02586324|Biological|global medium|
16041373|NCT02586324|Biological|SSM|
16041374|NCT02586311|Drug|CKD-330 16/5mg|Once a day, 8 weeks
16041375|NCT02586311|Drug|Amlodipine 5mg Placebo|Once a day, 8 weeks
16041376|NCT02586311|Drug|CKD-330 16/5mg Placebo|Once a day, 8 weeks
16041377|NCT02586311|Drug|Amlodipine 5mg|Once a day, 8 weeks
16041378|NCT02586298|Other|Autologous mitochondria with ICSI|Autologous mitochondria during the intracytoplasmic sperm injection (ICSI) process will be added to this randomized group of oocytes.
16041379|NCT02586298|Other|STANDARD ICSI PROCEDURE|STANDARD ICSI PROCEDURE
16041380|NCT02586285|Drug|S-Adenosyl Methionine|500mg-1000mg,iv,qd
16041381|NCT02586272|Device|Daifert|
16041382|NCT02586272|Procedure|Control Group|
16041383|NCT02586259|Drug|budesonide MMX®|
16041384|NCT02586246|Drug|CDP870|Self-injection
16041385|NCT02586233|Drug|DS-1040b|DS-1040b for IV infusion (0.6 mg to 9.6 mg) over 6-hour period
16041386|NCT02586233|Drug|Placebo|0.9% sodium chloride (placebo comparator) for IV infusion over 6-hour period
16041387|NCT02586207|Drug|pembrolizumab (MK-3475)|200mg IV on days -7(loading dose), 15, 36, 57, 78, 99, 120, 141.
16041388|NCT02586207|Drug|Cisplatin|Cisplatin 40 mg/m2 IV on days 1, 8, 15, 22, 29, 36
16041389|NCT02586207|Radiation|Radiation|70 Gy fractionated over 35 days
16041390|NCT02586194|Drug|ASP015K|Oral
16041391|NCT02586181|Dietary Supplement|Vitamin D and Calcium|"a combination of dietary supplement including all 1200 IE Vitamin D3 plus 800 mg Calcium Carbonate
~1200 IE Vitamin D3 plus 800 mg Calcium Carbonate
~Arm: Experimental: Vitamin D, Calcium, Vitamins B9, B6, B12
~1200 IE Vitamin D3 plus 800 mg Calcium Carbonate plus 0,5mg Folic acid, 50 mg B6, 0,5 mg B12"
16041392|NCT02586181|Dietary Supplement|Vitamin D, Calcium, Vitamins B9, B6, B12|"a combination of dietary supplement including all 1200 IE Vitamin D3 plus 800 mg Calcium Carbonate plus 0,5mg Folic acid, 50 mg B6, 0,5 mg B12"
16041393|NCT02586168|Drug|Gemcabene 900 mg|Gemcabene 900 mg once daily (QD)
16041394|NCT02586168|Drug|Placebo|Placebo
16041395|NCT02586155|Drug|Apabetalone|100 mg capsule
16041396|NCT02586155|Drug|Placebo|Capsule manufactured to mimic RVX000222 100 mg capsule
16041400|NCT02586142|Other|Stretching exercise|After accepting Botulinum toxin type A injection, participants will be arranged to receive stretch exercise in Kaohsiung Chang Gung Memorial Hospital 3 times per week, for 3 month.
16041401|NCT02586129|Drug|YH14755|20/1500mg, QD
16041402|NCT02586129|Drug|Metformin|1500mg, QD
16041403|NCT02586129|Drug|Rosuvastatin|20mg, QD
16041404|NCT02586116|Device|nanOss|nanOss Cervical Interbody Fusion Device with nanOss BA bone void filler.
16041405|NCT02586116|Device|C-Plus|C-Plus PEEK IBF Device with autograft
16041406|NCT02586103|Device|MRI simulation|It is not a working MRI machine but sounds and feels just like the real machine.
16041407|NCT02586090|Behavioral|Parents as Coaches|PAC (modeled after NIH-funded NOURISH) focuses on parenting strategies to support and facilitate their child's weight management via family-based change. Each visit includes group psychoeducation and discussion, focused on parenting strategies to facilitate healthy weight management in their child(ren). Topics include focus such as role modeling, strategies for healthy lifestyle changes, and how to be a coach to your teen.
16041408|NCT02586090|Behavioral|Parent Weight Loss|In PWL parents will be given a weight loss goal of 1-2 lbs/week, as well as specific calorie and fat prescriptions, PA goals, and instructions to self-monitor key information. Parents will receive training in core behavioral weight loss strategies (e.g., goal setting, stimulus control) and techniques to help them achieve these goals and will also receive personalized feedback throughout the program
16041409|NCT02586077|Drug|Exparel|
16041410|NCT02586064|Behavioral|Interpersonal Therapy for PTSD|Relationally focused treatment that focuses on relationship problems that may be caused or maintained by PTSD symptoms. Consists of 12 individual weekly sessions of 45 to 50 minutes. Includes psycho-education, assessing which relationships (or lack of) are causing problems for the Veteran, and addressing the problem areas identified through specific strategies (e.g. communication analysis, decision analysis, role play). Final 2 sessions focus on consolidating what has been learned, what issues remain, identifying types of relationship triggers that could reactivate symptoms, and addressing feelings about termination.
16041411|NCT02586064|Behavioral|Prolonged Exposure|Aim is to allow Veterans to re-experience traumatic events experienced during military service in a safe and supportive environment, and to re-engage in activities they have been avoiding. 12 individual weekly sessions of 90 minutes. Consists of psychoeducation, breathing retraining, imaginal exposure (repeated imaginal recall of the trauma including sensory details, and associated thoughts and feelings experienced during the trauma), and with trauma, and in vivo exposure (systematically confronting feared and avoided places and activities).
16041412|NCT02586051|Drug|Obinutuzumab|Obinutuzumab 1000 milligrams (mg) IV infusion.
16041413|NCT02586051|Drug|Intravenous Immunoglobulin|High dose (2 grams per kilogram [g/kg]) IVIG (maximum 140 grams).
16041414|NCT02586038|Drug|MLN9708|
16041415|NCT02586038|Drug|Dexamethasone|
16041416|NCT02586038|Drug|Cyclophosphamide|
16041417|NCT02586038|Drug|Thalidomide|
16041418|NCT02586025|Drug|FEC Chemotherapy|Fluorouracil 500-600 milligrams per square meter (mg/m2), epirubicin 90-120 mg/m2, and cyclophosphamide 500-600 mg/m2 by intravenous (IV) infusion every 3 weeks for three cycles (Cycles 5-7). FEC chemotherapeutic agents will be administered following surgery on Day 1 of each specified cycle.
16041419|NCT02586025|Procedure|Surgery|All participants who are eligible for surgery will undergo surgery and have their pathologic response evaluated.
16041420|NCT02586025|Drug|Docetaxel|Docetaxel IV infusion in 3-week cycles. Neoadjuvant treatment: 75 mg/m2 for Cycles 1-4.
16041421|NCT02586025|Drug|Pertuzumab|Pertuzumab IV infusion in 3-week cycles. Prior to surgery (neoadjuvant treatment): 840 milligrams (mg) loading dose for Cycle 1, followed by 420 mg for Cycles 2-4. After surgery and 3 cycles of FEC chemotherapy (adjuvant treatment): 840 mg loading dose for Cycle 8, followed by 420 mg for Cycles 9-20)
16041422|NCT02586025|Drug|Placebo|Placebo by IV infusion in 3-week cycles as neoadjuvant treatment (Cycles 1-4)and as adjuvant treatment (Cycles 8-20)
16041423|NCT02586025|Drug|Trastuzumab|Trastuzumab IV infusion in 3-week cycles. Neoadjuvant treatment: 8 milligrams per kilogram (mg/kg) loading dose for Cycle 1, followed by 6 mg/kg for Cycles 2-4. Adjuvant treatment: 8 mg/kg loading dose for Cycle 8, followed by 6 mg/kg for Cycles 9-20.
16041424|NCT02586012|Drug|rFVIII|Recombinant FVIII concentrate is an FDA approved, and both efficacious and safe, therapy for the treatment and prevention of bleeding in hemophilia A. The rFVIII infusion dose will be calculated as follows: [(weight in kg x desired FVIII increase of 100 IU/dL)/(2)].
16041425|NCT02585999|Device|Xulane Contraceptive Patch|Extended use (12 weeks) of contraceptive patch
16041426|NCT02585986|Dietary Supplement|Probiotic|daily intake of 1 capsule probiotic
16041427|NCT02585986|Dietary Supplement|Placebo|daily intake of 1 capsule containing placebo
16041428|NCT02585973|Drug|AZD1775|AZD1775 given twice daily (BID) for three consecutive days (M-W) concomitantly with standard of care cisplatin and radiation. AZD1775 doses will be escalated in 50 mg increments up to 200 mg BID (M-W) in subsequent cohorts to determine the MTD.
16041429|NCT02585973|Drug|Cisplatin|40 mg/m2 IV infused over 1 hour D1 of each week of radiation
16041430|NCT02585973|Radiation|Intensity Modulated Radiotherapy Treatments|Total dose will be 70 Gy at 2Gy/fx, 35 fractions, M to Fri, for 7 weeks
16041431|NCT02585960|Biological|PEGylated Recombinant Factor VIII|Pharmacokinetic (PK) evaluation
16041432|NCT02585960|Biological|PEGylated Recombinant Factor VIII|Standard treatment
16041433|NCT02585960|Biological|PEGylated Recombinant Factor VIII|Intensified treatment
16041434|NCT02585947|Drug|Tenofovir|Anti-HBc positive patients with Non-Hodgkin's lymphoma planned to receive rituximab based chemotherapy will be randomized to either Group A or Group B in a 1:1 ratio and will be monitored every 12 weeks from the start of treatment for up to 72 weeks after the end of chemotherapy (EOC).
16041435|NCT02585934|Drug|RVT-101|once daily, oral, 35 mg tablets
16041436|NCT02585934|Drug|Placebo|once daily, oral, pill manufactured to match RVT-101 35 mg tablet
16041437|NCT02585921|Behavioral|Video Interventions|Participants will watch 2 5-minute videos and then discuss them as a group.
16041438|NCT02585921|Behavioral|Donation Discussion Education|Participants will learn techniques for introducing and discussing organ donation with parents and guardians.
16041439|NCT02585908|Biological|CIK|CIK cells will be used against tumor cells.
16041440|NCT02585908|Biological|γδ T|γδ T cells will be used against tumor cells.
16041441|NCT02585908|Biological|CIK and γδ T|CIK and γδ T cells will be used against tumor cells.
16041442|NCT02585895|Biological|Evolocumab|Administered by subcutaneous injection once every 2 weeks
16041443|NCT02585895|Procedure|Low-density Lipoprotein Cholesterol (LDL-C) Apheresis|Participants received apheresis for LDL-C according the their physician's prescription and local custom.
16041444|NCT02585882|Other|Fluoride table salt|
16041445|NCT02585869|Drug|Gemcabene 150 mg|Blinded capsules and tablets, 150 mg, once daily, 84 days
16041446|NCT02585869|Drug|Gemcabene 300 mg|Blinded capsules and tablets, 300 mg, once daily, 84 days
16041447|NCT02585869|Drug|Gemcabene 600 mg|Blinded capsules and tablets, 600 mg, once daily, 84 days
16041448|NCT02585869|Drug|Gemcabene 900 mg|Blinded capsules and tablets, 900 mg, once daily, 84 days
16041449|NCT02585869|Drug|Placebo|Blinded capsule and tablets, once daily, 84 days
16041450|NCT02585856|Device|PDT|"Patients with unresectable CCA are performed PDT with ERCP after porfimer sodium （chongqing ray high medical instrument co., LTD，Chongqing, China) i.v. at a dose of 2 mg/kg at 48 h.
~PDT procedure: for light distribution, flexible cylindrical diffuser probes mounted on 400-mm quartz fibres with an active distal tip length of 2 cm （chongqing ray high medical instrument co., LTD，Chongqing, China) is used. The light source was a diode laser system with a maximum power output of 2 Wand a wavelength of 633.3 nm. The power emitted by the diffuser tip was calibrated to 400 mW/cm before PDT was administered using an integrating sphere power meter. The mean irradiation time was 452 s (range: 400-600 s), using a power density of 300-400 mW/cm and an energy dose of 180-200 J/cm (of diffuser length)."
16041451|NCT02585856|Device|stent|Patients with unresectable CCA are performed with ERCP, one or several plastic biliary stents (Boston Scientific Corporation, MA,USA) are inserted to ensure adequate decompression and bile drainage.
16041452|NCT02585843|Drug|Spironolactone 100mg|2 capsules of study medication consist of 100mg, PO (oral) for 7 days
16041453|NCT02585843|Drug|Spironolactone 25mg|25mg/day of spironolactone
16041454|NCT02585817|Device|Remote CIED Management|Information Technology
16041455|NCT02585804|Drug|Dapagliflozin|Oral tablet, 10mg, PO, 8 weeks
16041456|NCT02585791|Other|Propylene Glycol|inhaled Propylene Glycol (PG) by vaporing
16041457|NCT02585791|Other|vegetable glycerin|inhaled vegetable glycerin (VG) by vaporing
16041458|NCT02585791|Other|PG+VG|inhaled PG+VG by vaporing
16041459|NCT02585778|Drug|Alirocumab|Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector.
16041460|NCT02585778|Drug|Placebo|Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector.
16041461|NCT02585778|Drug|Lipid-Modifying Therapy (LMT)|Statins at stable, maximally tolerated dose with or without other LMT as clinically indicated.
16041462|NCT02585778|Drug|Antihyperglycemic Drug|Insulin (injectable or inhaled) alone or with other antihyperglycemic drugs as clinically indicated.
16041463|NCT02585765|Drug|Pioglitazone|8 weeks of daily pioglitazone (30 mg/d).
16041464|NCT02585765|Drug|Placebo|8 weeks of daily placebo capsules.
16041465|NCT02585752|Device|Noninvasive ventilation|Expiratory pressure modulation
16041466|NCT02585739|Genetic|blood sample|
16041467|NCT02585726|Device|SP-402 VenaSeal™ Closure System|A medical device kit consisting of seven delivery tools and the proprietary VenaSeal™ Adhesive (Medtronic Cardiovascular, Santa Rosa, CA). The device is used to treat venous reflux in lower extremity superficial truncal veins for subjects in the treatment arm..
16041468|NCT02585713|Drug|Apixaban|Given PO
16041469|NCT02585713|Drug|Dalteparin|Given SC
16041470|NCT02585713|Other|Questionnaire Administration|Ancillary studies
16041471|NCT02585700|Biological|Influenza vaccine, split inactivated|Seasonal trivalent inactivated influenza vaccine (TIV), inactivated split virion, purified by sucrose gradient ultracentrifugation. The vaccine is produced in hen's eggs, and inactivated with beta-propiolactone.
16041472|NCT02585700|Other|Placebo|0.5 mL of phosphate buffered saline
16041473|NCT02585687|Device|liver Perfusion MRI|
16041474|NCT02585674|Drug|Insulin glargine (U300)|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous"
16041475|NCT02585674|Device|MyStar DoseCoach|Glucose meter
16041476|NCT02585661|Dietary Supplement|Dairy product fortified with enriched Fe-54 salt (1)|2.5mg of Fe per 100g of product
16041477|NCT02585661|Dietary Supplement|Dairy product fortified with enriched Fe-57 salt (2)|2.5mg of Fe per 100g of product
16041478|NCT02585648|Device|Thealoz Duo Gel and Thealoz Duo eye drops|Thealoz Duo gel at night (1 drop before going to bed) + Thealoz Duo eye drops during the day (4 to 6 drops per day)
16041479|NCT02585648|Device|Thealoz Duo eye drops|Thealoz Duo eye drops during the day (4 to 6 drops per day)
16041480|NCT02585622|Biological|Mesenchymal Stromal Cells|Cells will be administered intravenously at 3 different doses (80, 160, or 240 x 10^6, fixed dose) over 10-20 minutes. Volume total of fluid infused: 40 ml
16041481|NCT02585622|Other|Placebo|Volume total of fluid infused: 40 ml
16041482|NCT02585596|Drug|YH23537 1000mg/day|YH23537 500mg 2 tab
16041483|NCT02585596|Drug|YH23537 2000mg/day|YH23537 500mg 4 tab
16041484|NCT02585596|Drug|YH23537 3000mg/day|YH23537 500mg 6 tab
16041485|NCT02585596|Drug|placebo|YH23537 500mg tab placebo
16041486|NCT02585583|Radiation|Thalamotomy|VoA-Vop complex of the thalamous or VIM nucleus will be targeted. 100 Gy, 120 Gy, 130 Gy, 140 Gy will be the foreseen prescription dose. CyberKnife will be always used to perform the procedure.
16041487|NCT02585570|Drug|Phenylephrine|Patients is received phenylephrine 1.0 mcg/kg/min or 0.5 mcg/kg/min for 5 minutes before being placed in the beach chair position.
16041488|NCT02585557|Other|Primary Care Practice Support|The intervention consists of practice facilitation, academic detailing, and regional learning collaboratives.
16041489|NCT02585544|Procedure|day-care surgery|day-care surgery
16041490|NCT02585531|Drug|Hypertonic Saline 3%|"The treatment will be administered in the following order :
~First day: 3 treatments of nebulized HS 3% 3ml of treatment with interval 20 minutes Second to fourth day: One treatment of nebulized HS 3% 3ml every 24 hours ."
16041528|NCT02585206|Behavioral|Message Intensity|"Phase I Factor
~Varying levels of text message intensity over a 12-week period."
16041491|NCT02585531|Drug|Epinephrine and Dexamethasone|"The treatment will be administered in the following order :
~First day: One treatment of nebulized dexamethasone 4mg (1ml of dexamethasone 8mg/2ml) + 3ml NS, followed by two treatments of nebulized epinephrine (3 ml of epinephrine in a 1:1000 solution per treatment) with interval 20 minutes Second to fourth day: One treatment of nebulized dexamethasone 4 mg (1ml of dexamethasone 8mg/2ml) + 3ml Normal saline 0.9%, every 24 hours."
16041492|NCT02585505|Procedure|stem cells|stem cell will be injected
16041493|NCT02585492|Other|Head-of-bed elevated 15°|Head-of-bed elevated 15° during 2 hours after delivery.
16041494|NCT02585492|Other|Head-of-bed elevated 45°|Head-of-bed elevated 45° during 2 hours after delivery.
16041495|NCT02585479|Drug|Pirarubicin|"Pirarubicin 30mg/m2 intravenously
~Pirarubicin17mg/m2 are infused through the right and left hepatic arteries"
16041496|NCT02585479|Drug|Oxaliplatin|"Oxaliplatin 100 mg/m2 intravenously
~Oxaliplatin 30mg/m2 are infused through the right and left hepatic arteries"
16041497|NCT02585479|Drug|Lipiodol|Lipiodol 5-10ml infused through the right and left hepatic arteries
16041498|NCT02585479|Device|Gelfoam|Hepatic artery embolization with Gelfoam.
16041499|NCT02585453|Device|Thealoz Duo Gel|Manufacturer: Laboratoires Thea, France
16041500|NCT02585453|Device|Hylo-Gel|Manufacturer: Ursapharm, Saarbrücken, Germany
16041501|NCT02585453|Device|Systane Gel Drops|Manufacturer: Alcon Pharma GmbH, Fort Worth, TX, USA
16041502|NCT02585440|Drug|CMX157|Oral tablet
16041503|NCT02585440|Drug|placebo|Oral tablet
16041504|NCT02585427|Dietary Supplement|low glycemic index rice, high glycemic index rice, butter, olive oil and grapeseed oil|
16041505|NCT02585401|Drug|Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)|The physician questionnaire will contain primarily closed-ended questions (e.g., multiple choice, true/false), with few free-text response fields, eliciting responses measuring physician knowledge and understanding of the key information in the Eylea vial preparation instruction card, the intravitreal injection procedure video, and the product monograph.
16041506|NCT02585388|Drug|Vinorelbine|Vinorelbine metronomic at 50 mg (1 tablet at 20 mg and 1 tablet at 30mg),per oral, 3 times per week. One dose level reduction is authorized at 30 mg per day.when stopping over 3 consecutive weeks due to toxicity, treatment should be permanently discontinued
16041507|NCT02585388|Drug|Letrozole|Lestrozole at 2,5 mg every day , per oral
16041508|NCT02585388|Drug|Anastrozole|Anastrozole at 1 mg every day, per oral
16041509|NCT02585375|Drug|Preservative-free latanoprost 50µg/ml|
16041510|NCT02585375|Drug|Preserved latanoprost 0.005%|
16041511|NCT02585362|Behavioral|physical exercise|The standardized Training program will be performed twice a week in the Kantonsspital Winterthur and once a week in a home based setting
16041512|NCT02585362|Behavioral|nutrition counseling|At least 3 times, participants will receive nutrition counseling to improve energy- and protein intake
16041513|NCT02585362|Dietary Supplement|whey protein supplement|On workout days study participants will consume twice a day 15 g of the supplement powder with approximately 150 ml water. On the remaining days participants consume the supplement once a day.
16041514|NCT02585336|Behavioral|Brief intervention|An interviewer provides health information, elicits motivation to reduce SSB consumption, and helps participants make implementation plans. Booster phone calls occur at 1 week after the intervention visit, and at 2 weeks and 24 weeks following the date on which SSBs sales ended at the participant's work location.
16041515|NCT02585323|Behavioral|Education session, Fitbit/FitViz, PT counselling|Participants will receive a brief education session, use a physical activity tracker Fitbit Flex with paired with a FitViz app, and remote counseling by a PT. Intervention will be received immediately.
16041516|NCT02585323|Behavioral|Same intervention with a 3 month delay|The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 3 month delay.
16041517|NCT02585310|Other|Packed red blood cell transfusion|Record number of PRBC transfusion during perioperative period.
16041518|NCT02585297|Other|no intervention|
16041519|NCT02585271|Device|Transanal decompression tube|22 Fr transanal decompression tube
16041520|NCT02585271|Device|Stent|self-expandable colorectal nitinol alloys stent
16041521|NCT02585258|Drug|Prednisolone|capsules 5 mg / day
16041522|NCT02585258|Other|Placebo|capsules 1 / day
16041523|NCT02585232|Behavioral|Counseling (C)|The counseling component incorporates elements of existing manualized interventions that have been tailored for this population and follow a cognitive behavioral therapy framework. Counseling sessions will be completed for 8-10 domains of potential distress (grief, hostility, sexual intimacy, etc.).
16041524|NCT02585232|Behavioral|Care Consultation (CC)|"Care Consultation (CC): is an established telephone-based, empowerment intervention that uses coaching and emotional support to mobilize family caregivers and individuals with dementia through psychoeducation, resource referral, psychosocial support, and encouragement of informal and formal service use utilization. A computerized clinical tool called the Care Consultation Information System (CCIS) guides the care consultant through a standardized delivery of protocol components. Rather than a strong focus on assessment, this intervention is designed to quickly identify areas of unmet need through brief trigger questions called the initial assessment, which then immediately shapes development of concrete action plans."
16041525|NCT02585206|Behavioral|Personalization|"Phase I Factor
~Personalized text messages using the participant's username and gender (Check out the EX Community for tips/support from other men who have quit. They've been there and can help you do this, QuitForever!). Both data points will be pulled from BecomeAnEX registration data."
16041526|NCT02585206|Behavioral|Integration|"Phase I Factor
~Interactive messages to facilitate engagement via text with the 6 interactive intervention components of the BecomeAnEX web intervention:
~Set your quit date Cigarette tracker Beat your smoking triggers Build your support system Choose a quit smoking aid Community
~Integration will allow interaction with the web-based program via text message; for example, when a user sets a quit date via the website, it will trigger text messages tailored to the quit date; likewise, if a user sets a quit date via the text system, it will be populated in the website and drive the user experience online."
16041527|NCT02585206|Behavioral|Dynamic Tailoring|Individually tailored message to remind/reinforce users about BecomeAnEX information/tools they have already used, or to prompt users to take actions they have not yet taken.
16042561|NCT02578056|Procedure|Genital prolapse surgery|Surgical correction of genital prolapse
16041529|NCT02585206|Behavioral|Optimal-Adherence Text|Optimal-adherence text message intervention developed in Phase I
16041530|NCT02585193|Behavioral|Weight Watchers Intervention|All participants are enrolled in this single arm of the study. All participants receive the Weight Watchers intervention which consists of weekly group intervention/support meetings in which weight loss behaviors (diet, physical activity) are discussed.
16041531|NCT02585180|Device|Endotracheal tubes not allowing SSD|In each participating center, a bundle of VAP prevention will be applied: elevate the head of the bed to 30°-45°, regular oral care, manage patients with sedation algorithm, assess readiness to extubate daily, intermittent control of endotracheal tube cuff pressure
16041532|NCT02585180|Device|Endotracheal tubes allowing SSD|"In each participating center, a bundle of VAP prevention will be applied: elevate the head of the bed to 30°-45°, regular oral care, manage patients with sedation algorithm, assess readiness to extubate daily, intermittent control of endotracheal tube cuff pressure.
~In addition, SSD will be realized using a 10 ml syringe at in attending frequency of 2 hours."
16041533|NCT02585167|Procedure|operation|the fistula will be excised after dividing the sphincter and primary reconstruction will be performed with absorbable sutures, closing the internal opening and leaving the external opening unclosed for drainage.
16041534|NCT02585167|Device|VAAFT|Karl Storz Video Equipment is used. The fistula tract will be visualized from the external to the internal opening, closing the internal opening with absorbable sutures, then brushing and cauterization of the tract(s) leaving the external opening unclosed for drainage.
16041535|NCT02585154|Procedure|Deep Brain Stimulation applied through custom built external stimulator (Little et al., 2013, 2015)|'Classical' high-frequency Deep Brain Stimulation, which is applied irrespective of ongoing brain activity.
16041536|NCT02585154|Procedure|closed-loop Deep Brain Stimulation applied through custom built external stimulator (Little et al., 2013, 2015)|Deep Brain Stimulation, which is applied depending on ongoing brain activity.
16041537|NCT02585154|Procedure|Deep Brain Stimulation off|Deep Brain Stimulation is turned off.
16041538|NCT02585154|Device|local field potentials and electroencephalography recordings|Simultaneous recordings of local field potentials from subthalamic nucleus and electroencephalography
16041539|NCT02585141|Device|MEDIPLAST® (aspiration)|The aspiration drainage will be with a large caliber needle (MEDIPLAST® 13 G, 2,5 x 110 mm) and a syringe of 20 ml. The cavity must be emptied for pus and irrigated by repeated injection and aspiration of saline until clear fluid is obtained.
16041540|NCT02585141|Procedure|incision|Incision drainage will be undertaken as standardized de-roofing of the abscess and debridement. Wound packing and dressing will not be used, just sitz bath or ordinary hygiene until wound healing.
16041541|NCT02585141|Drug|Clindamycin|Postoperative broad spectrum oral antibiotics covering both aerobes and anaerobes bacteria will be given for seven days of Clindamycin 300 mg tablets x 3 a day
16041542|NCT02585128|Other|Delirium assessment|During the first post-procedural five days all patients will be evaluated on a daily basis for delirium occurrence by the CAM (Confusion Assessment Method) or CAM - ICU (Confusion Assessment Method - Intensive Care Unit)
16041543|NCT02585128|Other|MMSE (Mini Mental State Examination)|
16041544|NCT02585128|Other|Barthel index|
16041545|NCT02585128|Other|HADS (Hospital Anxiety and Depression Scale)|
16041546|NCT02585128|Other|MNA-SF (Mini Nutritional Assessment - Short Form)|
16041547|NCT02585128|Device|NIRS (Near-Infrared Spectroscopy)|Regional cerebral oxygen saturation monitoring during TAVI procedure
16041548|NCT02585128|Other|CIRS (Cumulative Illness Rating Scale)|
16041549|NCT02585102|Other|Recommended Vegetable Intake|Subjects will consume vegetables in amounts recommended by the Dietary Guidelines for Americans
16041550|NCT02585102|Other|Usual Vegetable Intake|Subjects will consume vegetables in their usual amount
16041551|NCT02585089|Other|Spanish cured-pork ham|"Dry-cured ham with reduced salt will be used in order to decrease the sodium intake that could affect blood pressure too. Such ham contains 25% lower salt than similar products on the market (3,7g vs 4,5g/100g).
~Volunteers will receive 80g of cured pork ham daily for 28 consecutive days. They can eat the interventional product at any time of the day."
16041552|NCT02585089|Other|Cooked pork ham|Volunteers will receive 100g of cooked pork ham daily for 28 consecutive days. They can eat the product (placebo product) at any time of the day.
16041553|NCT02585076|Other|Standard of care|As prescribed by treated physician
16041554|NCT02585037|Other|Kinesio Taping® bandage|"The Kinesio Taping® bandage will be applied in an I format in the wrist flexor muscles of a dominant and non-dominant limb in G1 and G2 groups."
16041555|NCT02585037|Other|Dynamometer Jamar® pressure|The Jamar® dynamometer will be adjusted to the second position for measurement of maximal voluntary strength of handgrip. A muscle contraction period of three seconds will be performed in order to record handgrip strength.
16041556|NCT02585037|Other|Placebo|For the control group (G3) the Kinesio Taping® bandage will be placed from the lateral extremity to the medial axis.
16041557|NCT02585024|Drug|Cytisine|
16041558|NCT02585011|Drug|Ropivacaine|
16041559|NCT02585011|Drug|Epinephrine|
16041560|NCT02585011|Drug|Saline|
16041561|NCT02584998|Other|Mailed-FIT|The FIT is analyzed at the Philadelphia VAMC by an auto-analyzer system that provides quantitative results corresponding to the concentration of hemoglobin in the collected sample. Specimens will be analyzed according to manufacturer's instructions to minimize potential degradation of hemoglobin. Results are provided as positive if the hemoglobin concentration is 100ng/dL. The machine records (but does not report) the quantitative results of the hemoglobin concentration in the sample, which we will seek to obtain from the laboratory for future studies.
16041562|NCT02584998|Other|Screening invitation-reminder|These patients will continue to receive UC. They will in addition receive an invitation letter with all of the information about CRC testing in the mail-FIT arm
16041563|NCT02584985|Procedure|ETAP|Primary transanal endoscopic approach, secondary transabdominal laparoscopic approach
16041564|NCT02584985|Procedure|Standard Transabdominal Laparoscopic Proctectomy|Primary transabdominal laparoscopic approach
16041565|NCT02584972|Other|no intervention required|no intervention required
16041566|NCT02584959|Drug|C1 esterase inhibitor [human] liquid|C1 Esterase Inhibitor [Human] Liquid administered Subcutaneously as specified on specified days
16041567|NCT02584959|Drug|Placebo|Placebo
16041568|NCT02584946|Other|Avenanthramides|AVAs are a group of diphenolic acids that are found only in oats (Avena sativa).
16041570|NCT02584920|Drug|HLX01|
16041571|NCT02584920|Drug|Rituximab|
16041572|NCT02584907|Other|High Fat Enteral Nutrition|Diet in high fat group will be 20% from protein, 45% from fat and 35% from carbohydrate
16041573|NCT02584894|Device|rTMS 1Hz|trauma exposure + repeated transcranial magnetic stimulation at 1Hz
16041574|NCT02584894|Device|rTMS 10Hz|trauma exposure + repeated transcranial magnetic stimulation at 10Hz
16041575|NCT02584894|Behavioral|psychoneurological assessment|psychoneurological assessment
16041576|NCT02584894|Device|conductivity meter|electrodermal conductance measure
16041577|NCT02584894|Device|electrocardiogram|heart rate measure
16041578|NCT02584881|Other|safe opioid prescription protocol|When indicated a prescription for naloxone will be given to patients discharged with prescription opioids from the trauma services. All patients will receive information on safe opioid use and storage and methods for pain management.
16041579|NCT02584868|Drug|Hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution|Peri-operative fluid replacement therapy (max 40ml/kg/day)
16041580|NCT02584868|Drug|Hydroxyethyl starch 130/0.4 in 0.9% sodium chloride|Peri-operative fluid replacement therapy (max 40ml/kg/day)
16041581|NCT02584855|Drug|Ixekizumab|Administered SC
16041582|NCT02584855|Drug|Placebo|Administered SC
16041583|NCT02584829|Drug|Avelumab|Given IV
16041584|NCT02584829|Other|Laboratory Biomarker Analysis|Correlative studies
16041585|NCT02584829|Biological|MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells|Given IV
16041586|NCT02584829|Radiation|Radiation Therapy|Undergo radiation therapy
16041587|NCT02584829|Biological|Recombinant Interferon Beta|Given via intra-tumor injection
16041588|NCT02584816|Biological|BRV-PV Lot A + DPT-HepB-Hib + OPV|Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week
16041589|NCT02584816|Biological|BRV-PV Lot B + DPT-HepB-Hib + OPV|Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week
16041590|NCT02584816|Biological|BRV-PV Lot C + DPT-HepB-Hib + OPV|Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week
16041591|NCT02584816|Biological|ROTARIX + DPT-HepB-Hib + OPV|Dose 1: 6-8 weeks, Dose 2: 10 week, Dose 3: 14 week (Third dose-Placebo)
16041592|NCT02584803|Radiation|Ultrasound|"Evaluating the feasibility and efficacy of IVC ultrasound imaging through the RUQ and subxiphoid view in term parturients.
~Patient Acceptability of procedure
~Patient Comfort:
~Ease of exam for the examiner"
16041593|NCT02584790|Device|Laryngoscope with NBI system|All post-radiotherapy 8 weeks NPC patient will routinely undergo laryngoscope examination (WL system) and NP biopsy will be taken at the same time to determine if there is any residual NPC. In this study, laryngoscope with NBI system will be used. NBI system will be turn on during the post radiotherapy 8 week laryngoscope examination in additional to routine WL system
16041594|NCT02584777|Biological|Pacritinib|QD (Once a day)
16041595|NCT02584764|Behavioral|Cognitive behavior therapy|
16041596|NCT02584764|Behavioral|Internet support|
16041597|NCT02584751|Drug|Omeprazole|Omeprazole is a commonly prescribed anti-reflux medication. If a SCI patient has GERD, they will be prescribed with 40mg omeprazole twice daily for two months
16041598|NCT02584751|Device|24 Hour pH Monitor|Monitors the acidity and levels of pH in the esophagus for 24hours and helps diagnose people with GERD
16041599|NCT02584751|Procedure|Pulmonary Function Examination|Assess pulmonary function such as lung volumes, spirometry, and max inspiration/expiration pressures.
16041600|NCT02584751|Procedure|Exhaled Nitric Oxide|Used to measure inflammation markers for airway resistance.
16041601|NCT02584751|Procedure|Exhaled Breath Concentrate (EBC)|EBC will be used to measure airway inflammation via specific markers, such as 8-isoprostane. This marker, if elevated, has been identified as an indicator for asthma inflammation.
16041602|NCT02584751|Procedure|Bernstein's Acid Clearance Test|Bernstein test is a clinical test for the diagnosis of chest pain in association with gastric acid exposure
16041603|NCT02584751|Procedure|Esophageal Motility|Esophageal Motility will be used to measure a subject's ability to swallow a bolus (i.e. saline solution) and record pressure changes throughout the esophagus during the swallow. This will also be used to identify anatomical landmarks, such as lower esophageal sphincter, which are necessary for proper placement of 24hr pH catheter.
16041604|NCT02584738|Drug|Nebulized Magnesium Sulfate|"Nebulized salbutamol and ipratropium bromide mixed with 2.5 ml of isotonic MgSO4 (150 mg) per dose every 20 minutes during the first hour.
~will be continued with nebulized standard treatment every hour for 4 hours."
16041605|NCT02584738|Drug|Nebulized isotonic saline|"Nebulized salbutamol and ipratropium bromide mixed with 2.5 ml of isotonic saline per dose every 20 minutes during the first hour.
~will be continued with nebulized standard treatment every hour for 4 hours."
16041606|NCT02584738|Drug|Nebulized Salbutamol|Nebulized salbutamol 2.5mg (2-5 years) or 5 mg (≥6 years)
16041607|NCT02584738|Drug|Ipratropium bromide|Nebulized ipratropium bromide 250 mcg
16041608|NCT02584738|Drug|Methylprednisolone or Prednisolone|Begin with intravenous methylprednisolone or oral prednisolone 2 mg/kg/day for each treatment
16041609|NCT02584725|Drug|Tranexamic Acid|Comparison of 3 different doses of the drug
16041610|NCT02584712|Other|Combined Exercise Training|This intervention consisted in 4 weeks of strength, flexibility and aerobic exercises made at the hospital and at home.
16041611|NCT02584699|Radiation|Stereotactic Ablative Radiotherapy (SABR)|Six Gy irradiation per fraction times 12 fractionations, resulting a total dose of 72Gy
16041612|NCT02584686|Drug|Botulinum Toxin Type A|The treatment group will be injected intracavernously with a trimix solution (20 ug alprostadil + 1 mg phentolamine + 30 mg papaverine) for colour Doppler assessment, followed next day by 50 units of BTX-A.
16041613|NCT02584686|Drug|Normal Saline|The control group, 12 patients, will be injected with a trimix solution during penile colour Doppler assessment followed next day with a normal saline injection.
16041655|NCT02584452|Drug|ropivacaine and dexamethasone|10cc of 0.5% ropivacaine + 2 mg dexamethasone (0. 5cc), keeping total injectate at 10.5cc to spare significant proximal spread to femoral nerve
16041656|NCT02584452|Drug|Propofol|Anesthesia induction will include a propofol bolus.
16041614|NCT02584673|Device|Computer Assisted Instrument Guidance (CAIG), which supplements existing ultrasound capabilities.|The Clear Guide ONE is a Computer Assisted Instrument Guidance (CAIG) device which supplements existing ultrasound capabilities. The participants randomly selected (out of 100 patients) for use of the Clear Guide ONE (test group) will receive ultrasound guidance as well as CAIG from the MDs performing the procedure.
16041615|NCT02584660|Drug|Rivaroxaban|Participants will receive Rivaroxaban 15 milligram (mg) twice daily up to Days 21 by orally and Rivaroxaban 20 mg once daily up to Days 90 by orally.
16041616|NCT02584660|Drug|Standard-of-care|Standard-of-care as per local protocol and defined by the medical team caring for the participant.
16041617|NCT02584647|Drug|PLX3397|PLX3397 is a small molecule that potently and selectively inhibits macrophage colony-stimulating factor receptor (FMS), Kit, and FMS-like tyrosine kinase 3 (Flt3)-internal tandem duplication (ITD) kinases, which regulate key components of the tumor microenvironment and oncogenic variants of these kinases that drive certain tumors.
16041618|NCT02584647|Drug|Sirolimus|"Sirolimus is a macrocyclic lactone that binds to tacrolimus (FK506) binding protein 12 and inhibits mammalian target of rapamycin (mTOR) resulting in cell-cycle arrest and apoptosis.
~Sirolimus is currently approved as an immunosuppressive agent for organ transplantation and more recently, as a component of cardiac arterial stents because of its potent antiproliferative effects on fibroblasts responsible for restenosis after such a procedure (26) Sirolimus is commonly administered orally on a daily basis, in doses ranging from 2 to 40 mg/day."
16041619|NCT02584634|Drug|Avelumab|Administered by IV once every two weeks in doses of either 5 mg/kg or 10 mg/kg
16041620|NCT02584634|Drug|PF-06463922|Tablets taken orally once every day in doses of either 100mg, 75mg, or 50mg.
16041621|NCT02584634|Drug|Crizotinib|Capsules. Taken orally once or twice every day in doses of either 200mg or 250mg.
16041622|NCT02584621|Behavioral|Check Yourself App with Feedback|
16041623|NCT02584608|Drug|ACTIMMUNE|
16041624|NCT02584595|Device|ICD/CRT-D with NIPS or EP Study|ICD/CRT-D implanted patients are tested for inducible MMVT during electrophysiology (EP) Study or Non-Invasive Programmed Stimulation (NIPS) Study
16041625|NCT02584582|Drug|Liraglutide|
16041626|NCT02584582|Drug|Exenatide|
16041627|NCT02584582|Procedure|Liquid meal test|
16041628|NCT02584582|Other|No drug (Baseline day)|
16041629|NCT02584569|Drug|TAK-915|TAK-915 oral suspension
16041630|NCT02584556|Drug|systemic chemotherapy|Pirarubicin(Brand Name:Pirarubicin - Main Luck Pharmaceutical, China) 30mg/m2 intravenously on Day 1 and Oxaliplatin(Brand Name: Eloxatin) 100 mg/m2 intravenously on Day 2 every 3 weeks starting 4-6 weeks after hepatic resection.
16041631|NCT02584556|Drug|Transcatheter Arterial Chemoembolization|Lipiodol 5-10ml,Pirarubicin17mg/m2 and Oxaliplatin 30mg/m2 are infused through the right and left hepatic arteries,followed by embolization using gelatin sponge particles(Gelfoam; Guangzhou) starting 4-6 weeks after hepatic resection.
16041632|NCT02584543|Biological|HEV vaccine|
16041633|NCT02584543|Biological|HBV vaccine|
16041634|NCT02584530|Procedure|Ultrasound guidance for PICC line placement|Apply ultrasound guidance for PICC line placement and positioning in newborns
16041635|NCT02584504|Drug|Alirocumab|Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector.
16041636|NCT02584504|Drug|Placebo|Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector.
16041637|NCT02584504|Drug|Atorvastatin|Atorvastatin 5 mg tablet orally.
16041638|NCT02584504|Drug|Non-statin Lipid-Modifying Therapy|Ezetimibe, Bezafibrate or Fenofibrate at stable dose as background therapy.
16041639|NCT02584504|Other|Diet Alone|Stable cholesterol-lowering diet as background therapy.
16041640|NCT02584491|Behavioral|Functional gait-related training|The motor learning (ML)-based functional gait-related training program is designed to improve advanced gross motor skills and athleticism. It will involve 45-min sessions twice to three times weekly over 6 weeks for a total of 16 active sessions. A maximum of 7 weeks will be permitted. Each session will consist of 35-min of active training along with a 10-min active warm-up/cool-down that incorporates ML. Scheduling flexibility will promote adherence, with a minimum one day between sessions to provide opportunity for rest. Children will be given a 3- to 5-min mental motor imagery script to practice on days when they do not have active training sessions. The total number of sessions (combined active/imagery) will be five per week.
16041641|NCT02584478|Drug|AL3818|Taken daily from Day 8 to Day 21 (14 days),administered orally combination with one background chemotherapy in 21-day cycles.
16041642|NCT02584478|Drug|Paclitaxel|"Weekly single agent Paclitaxel will be administered on Day 1, 8, and 15 of each 21-day cycle. Suggested dose: 80 mg/m^2 intravenously or local standard.
~Paclitaxel may also be administered once weekly with a 1-week break every 3 weeks in lieu of every week"
16041643|NCT02584478|Drug|Pegylated Liposomal Doxorubicin (PLD)|"Single agent Pegylated Liposomal Doxorubicin (PLD) administered every 4 weeks on the following cycle days corresponding with AL3818 cycles until maximum cumulative dose per local standard reached.
~Suggested dose: 40 mg/m^2 intravenously or local standard"
16041644|NCT02584478|Drug|Topotecan|Daily Topotecan on Days 1-5 of each 21-day cycle Suggested dose: 1.25 mg/m2 intravenously or local standard OR Weekly Topotecan with a 1 week break every 3 weeks. Suggested dose: 4 mg/m2 intravenously or local standard
16041645|NCT02584478|Drug|Topotecan|Weekly Topotecan with a 1 week break every 3 weeks Suggested dose: 4 mg/m2 intravenously or local standard
16041646|NCT02584478|Drug|Carboplatin|AUC 5/6 on Day 1 of each 21-Day cycles
16041647|NCT02584478|Drug|Paclitaxel|175mg/m2 IV over 3 hours on Day 1 of each 21-Day cycle
16041648|NCT02584478|Drug|AL3818|Taken daily from Day 8 to Day 21 (14 days). Administered orally.
16041649|NCT02584465|Drug|Tamoxifen|Tamoxifen: 40 mg/day
16041650|NCT02584465|Drug|Regorafenib|Stivarga; 120mg/day
16041651|NCT02584452|Drug|Mepivacaine|20cc of 2% mepivacaine <20 minutes prior to in room time.
16041652|NCT02584452|Procedure|adductor canal continuous nerve catheter|Placement of ultrasound guided adductor canal continuous nerve catheter
16041653|NCT02584452|Drug|Normal Saline as bolus followed by bupivacaine|normal saline as bolus for placement, followed by initiation of 1/8% bupivacaine infusion through adductor canal catheter at 8cc/h
16041654|NCT02584452|Procedure|adductor canal nerve block|ultrasound guided adductor canal nerve block
16041657|NCT02584452|Drug|Fentanyl|Intraoperative opioid should be limited to no more than 150mcg of fentanyl.
16041658|NCT02584439|Drug|ivabradine|It is a cross over study with two arms : either ivabradine-placebo or placebo-ivabradine. The capsules containing the placebo or ivabradine are completely identical.
16041659|NCT02584439|Drug|lactose capsule (placebo)|It is a cross over study with two arms : either ivabradine-placebo or placebo-ivabradine. The capsules containing the placebo or ivabradine are completely identical.
16041660|NCT02584426|Device|Ultrasonic Distribution of Cefazolin|
16041661|NCT02584413|Device|Magnetic resonance imaging|-Standard of care
16041662|NCT02584413|Drug|Gadolinium contrast|-Standard of care
16041663|NCT02584400|Drug|Injection with the hypoxia tracer [18F]HX4,|The [18F]HX4 PET scan will be performed, by administrating 444 MBq (12 mCi) [18F]HX4 via a bolus IV injection.
16041664|NCT02584387|Behavioral|3D Video Virtual Reality Exposure Therapy|The 3D video exposure therapy treatment will be administered using an oculus rift virtual reality headset. The oculus rift is a new, affordable virtual reality headset, which uses two different spherical lenses to induce a sense of stereoscopic 3D. Ortho-stereoscopic 3D refers to 3D videos that are designed to mimic the natural depth we normally see, as opposed to exaggerating it (i.e. Commercial 3D movies). To create these 3D videos, the UT 3D Department shot videos of live spiders using a stereoscopic 3D dual camera rig, which simultaneously shoots footage with two cameras positioned apart from each other in a way that mimics the natural pupillary distance between our right and left eyes. To create a sense of 3D depth, the footage of the right and left cameras is then projected on the two different lenses of the oculus rift, creating a sense of depth to the viewer through retinal disparity.
16041665|NCT02584374|Other|Venography with balloon occlusion test|First, regular venography of the venous iliac tract will be performed. Second, a 16mm diameter balloon will be inflated in the common iliac vein and venography will be repeated.
16041666|NCT02584361|Procedure|Round window approach|In this group the insertion of the electrode into cochlea will be performed through an incision in the membrane (paracentesis) of the round window (round window approach = RWA).
16041667|NCT02584361|Procedure|Cochleostomy|In this group the insertion of the electrode into cochlea will be performed by drilling a hole in cochlea (cochleostomy).
16041668|NCT02584348|Device|Gastric ultrasound|Preoperative qualitative ultrasound assessment of gastric contents will be performed for each children admitted for emergency surgery
16041669|NCT02584335|Drug|"Lidocaine solution (A)"|"Each of 26 patients will be evaluated during 6 consecutive wound treatments. The nurse will receive 3 syringes for each procedure, the syringe 1 always contains saline solution (blinded to the patient and to the nurse) to register the basal pain; the other two syringes are identical (number 2 and 3) and contain the study drug: lidocaine solution or saline solution.
~The investigators randomise the patients depending on the administration sequence (ABABAB or BABABA). When the procedure is A, the nurse will receive the syringes number 2 and 3 containing lidocaine solution to apply (blinded to the nurse, the patient and the doctor).
~Note: The investigators consider important apply both treatments (lidocaine solution and saline solution) alternatively to avoid the bias that could might fall a cause of wound evolution (to heal or to get worse). And it is important that the same patient receives both treatments to decrease the subjective component in pain perception."
16041670|NCT02584335|Drug|"Saline solution (B)"|"Each of 26 patients will be evaluated during 6 consecutive wound treatments. The nurse will receive 3 syringes for each procedure, the syringe 1 always contains saline solution (blinded to the patient and to the nurse) to register the basal pain; the other two syringes are identical (number 2 and 3) and contain the study drug: lidocaine solution or saline solution.
~The investigators randomise the patients depending on the administration sequence (ABABAB or BABABA). When the procedure is B, the nurse will receive the syringes number 2 and 3 containing saline solution to apply (blinded to the nurse, the patient and the doctor).
~Note: The investigators consider important apply both treatments (lidocaine solution and saline solution) alternatively to avoid the bias that could might fall a cause of wound evolution (to heal or to get worse). And it is important that the same patient receives both treatments to decrease the subjective component in pain perception."
16041671|NCT02584322|Other|Enhanced Recovery pathway|The enhanced recovery pathway consists of postoperative medical orders including nursing care, investigations and tests, and other peri-operative orders. The enhanced recovery pathway is standardized for all patients, and can be discontinued at any time when clinical judgment mandates (i.e. patient has a severe complication).
16041672|NCT02584309|Drug|Dexrazoxane|
16041673|NCT02584309|Drug|Doxorubicin|
16041674|NCT02584296|Behavioral|BSMA|Biobehavioral self-management approach (BSMA) intervention is aligned with information-motivation-behavioral skills (IMB) model and is guided physical activity (PA). Collects demographic, medical, disease, treatment data, blood specimens and the battery of measures. Includes PA self-assessment, 6 minute walk test(6MWT) and chair squat test (CST) with Physical Therapist (PT); provides PA handouts based on American Cancer Society (ACS) guidelines, discusses known benefits, beliefs and goals of PA (IMB health behavior motivation); assess/discuss perceived barriers to PA. PT or Exercise physiologist (EP) works with subject on various exercises (both strength and aerobic, ~30 minutes; IMB behavioral skills);PT or EP reviews exercises, subject practices, and provides a BSMA program (including strength/aerobic training) for subject to begin upon discharge. Subject keeps journal of PA and wears accelerometer (TAA) to record PA levels. 3-weeks at home study nurse calls subjects each week.
16041675|NCT02584283|Procedure|Dual hypothermic oxygenated perfusion|Dual hypothermic oxygenated perfusion using the Liver Assist
16041676|NCT02584283|Device|Liver Assist®|The Liver Assist® is the device used to give the intervention dual hypothermic perfusion.
16041677|NCT02584283|Procedure|Perfusion fluid|The perfusion fluid is Belzer machine perfusion solution University of Wisconsin (Bridge-to-Life, Ltd., Northbrook, IL).
16041678|NCT02584283|Drug|Glutathione|Glutathione in a dosage of 3 mmol/ is added to the perfusion fluid according to the intention of use of the perfusion fluid.
16041679|NCT02584270|Device|Palatal Augmentation Prosthesis (PAP)|The palatal augmentation prosthesis improves speech and swallowing function through reshaping the palatal contours in order to obtain contact of the tongue to the hard palate during function. It is intended to be fabricated after adequate healing in patients with adequate motivation for improvements in their speech and swallowing. Regular wear and associated articulation therapy are necessary for this therapy to be effective.
16042932|NCT02575651|Drug|Fluzoparib|Fluzoparib either at 10,20,40,80,120mg ....., capsule oral.
16041680|NCT02584270|Other|Articulation Therapy|Subjects will receive the standard of care speech and articulation therapy regardless of which arm they are matched.
16041681|NCT02584257|Other|methacholine chloride|
16041682|NCT02584257|Drug|placebo ProAir HFA|
16041683|NCT02584257|Drug|ProAir HFA|
16041684|NCT02584257|Drug|Lupin albuterol HFA MDI|
16041685|NCT02584257|Drug|placebo Lupin albuterol HFA MDI|
16041686|NCT02584244|Drug|LUM015|
16041687|NCT02584244|Device|LUM 2.6 Imaging Device|
16041688|NCT02584231|Drug|desmopressin|One time dosing of desmopressin oral lyophilisate formulation. The dose is age-dependant: >6 months and < 2years: 60µg; ≥2 years and <4 years: 120µg PO and ≥4 years and <8 years: 240 µg PO. There will be blood sampling and urine sampling for PK and PD/safety
16041689|NCT02584218|Procedure|Non-invasive resin based caries sealing|The dentists use resin based sealants of own choice, and follow their usual clinical procedures based on the instructions from the manufacturer and the guidelines from The Department of Pediatric Dentistry and Orthodontics, Federal University of Rio de Janeiro, Brazil
16041690|NCT02584218|Procedure|Invasive resin based restoration|The dentists use preparation design and resin composites of own choice, and follow their usual clinical procedures based on the instructions from the manufacturer and the guidelines from The Department of Pediatric Dentistry and Orthodontics, Federal University of Rio de Janeiro, Brazil
16041691|NCT02584205|Device|Powerbreathe|"In this intervention we will use an equipment called powerbreathe classic light. It provides us to choose resistance levels with an adjustable load setting range: 1 to 9 and it's ideal for beginners. In this research we will use it on the intervention group to improve the strength of inspiratory muscle training and evaluate the results in the functional capacity of the subjects with obstructive sleep apnea."
16041692|NCT02584192|Behavioral|entailing an early home-based CR program|enter the early outpatient phase of CR program. The progressive exercise training of this phase was performed without supervision after their discharge. The CR program consisted of a five-minute warm-up period (stretching), a twenty-minute aerobic exercise (walking or trotting, gymnastics), and a five-minute cooling-down period (stretching)
16041693|NCT02584192|Other|enter the usual care program|enter the usual care program, including the importance of carrying out physical activity, which was performed during inpatient care.
16041694|NCT02584179|Device|Biparametric MRI before biopsy|All included men with suspicious lesions on bpMRI will have bpMRI targeted biopsies in addition to standard TRUS-bx.
16041695|NCT02584166|Behavioral|multifaceted program|This program present two steps : a first step to revise protocols related to the management of cases (between M5 and M8) and a second step after M8 et M 26, with morbimortality conferences organized every trimester to analyze management with the staff.
16041696|NCT02584153|Drug|Fibrin Sealant|TISSEEL® fibrin sealant (Baxter Biosurgery, Deerfield, IL)
16041697|NCT02584153|Drug|Silver Microparticles|Product Code: AG-M-04M-P.200M (American Elements, Los Angeles, CA)
16041698|NCT02584140|Behavioral|Text Messaging|All participants assigned to the iTAB intervention will receive daily dosing reminders that will be sent for the first 6 weeks and then continue with reminders for the duration of the study.
16041699|NCT02584140|Behavioral|Adherence Counseling|All participants assigned to the counseling intervention will receive sexual health and medication adherence counseling at each study visit. Participants with suboptimal adherence (TFV-DP levels of <1050 fmol/punch (representing fewer than mean 6-7 daily doses per week)) will trigger a targeted iNSC session. Participants with two TFV-DP levels of <1050 fmol/punch will trigger PrEP Steps, a higher intensity adherence counseling intervention consisting of four 50-minute counseling sessions and 2 booster counseling sessions.
16041700|NCT02584140|Drug|Daily Oral PrEP|All participants will be offered daily oral emtricitabine/tenofovir disoproxil fumarate for Pre-exposure Prophylaxis.
16041701|NCT02584127|Behavioral|high reinforcement cessation program|Six-step, self-administered, internet smoking cessation program with high reinforcement.
16041702|NCT02584127|Behavioral|low reinforcement cessation program|Six-step, self-administered, internet smoking cessation program with low reinforcement.
16041703|NCT02584114|Behavioral|Peak app for memory training|
16041704|NCT02584114|Behavioral|Non-memory training group|
16041705|NCT02584101|Behavioral|ACT|ACT therapy administered in 3 sessions over a 4 week period
16041706|NCT02584101|Behavioral|Enhanced Treatment as Usual|2 group discussion sessions over a 4 week period
16041707|NCT02584088|Other|Ultrasound|The appearance of the post ablative endometrium on transvaginal ultrasound at 2, 6, and 12 months.
16041708|NCT02584075|Drug|Byetta (Exenatide)|Exenatide treatment: 5 µg twice/day subcutaneous injection for 4 weeks, 10 µg twice/day subcutaneous injection for 8 weeks.
16041709|NCT02584075|Drug|Glucophage ( Metformin Hydrochloride)|Metformin 500mg Tid
16041710|NCT02584062|Procedure|no-touch fluid-air exchange|
16041711|NCT02584062|Procedure|vitrectomy metrectomy and internal membrane peeling and gas tamponed|
16041712|NCT02584049|Other|Osteopathy|3 sessions of osteopathy during 60 minutes each
16041713|NCT02584049|Other|Sham osteopathy|3 sessions of sham osteopathy during 60 minutes each
16041714|NCT02584036|Biological|Vaccine administration by a pharmacist|Administration, number and types, of vaccine(s) by a pharmacist
16041715|NCT02584036|Behavioral|Unmet vaccination needs identified and met|Identification of unmet vaccination needs and having those needs met
16041716|NCT02584036|Behavioral|Vaccination forecast review and patient education|Pharmacist review of the vaccination forecast and patient education on his/her vaccine needs
16041717|NCT02584023|Device|Lung ultrasound|Lung ultrasound on both hemithorax in supine position
16041718|NCT02584010|Other|Silicon-based aerosol|Apply twice a day over the postoperative scar
16041719|NCT02584010|Other|Silicon-based gel|Apply twice a day over the postoperative scar
16041720|NCT02583997|Procedure|Suturing of lower alveoli|After extraction of wisdom teeth, the lower alveoli are sutured closed.
16041721|NCT02583997|Procedure|Non suturing of lower alveoli|After extraction of wisdom teeth, no alveoli are sutured closed.
16041722|NCT02583984|Procedure|Thoracic Surgery with Lung Resection|General anesthesia and lung separation Thoracic surgery with lung resection, such as lobectomy, segmentectomy
16041723|NCT02583984|Procedure|Thoracic Surgery without Lung Resection|General anesthesia and lung separation Thoracic surgery without lung resection, such as esophageal surgery, mediastinal surgery
16041724|NCT02583958|Device|Urgo 3103166|URGO 310 3166 dressing should be changed as often as required (let to the Investigator's convenience). The dressing change frequency is based on the exudate level and the clinical progress of the wound (up to 7 days).
16041725|NCT02583958|Device|Aquacel Extra|Aquacel Extra hydrofibre dressing can be left in place up to 7 days, where clinically indicated.
16041726|NCT02583945|Procedure|kidney treatment bundle (KDIGO)|Application of the measures of the kidney treatment bundle.
16041727|NCT02583932|Drug|Meaning-Making intervention (MMi)|The MMi is a brief, individualized and manualized therapeutic approach based on post-trauma literature and designed to facilitate a search for meaning following a cancer diagnosis.
16041728|NCT02583932|Behavioral|Empathic Visitor|They will provide the basic ingredients for fostering a good therapeutic relationship (i.e., trust, warmth, empathy, neutrality and authenticity) without further intervention or probing.
16041729|NCT02583919|Drug|ISIS-GCGRRx- Dose Level 1|once weekly dosing for 26 weeks
16041730|NCT02583919|Drug|ISIS-GCGRRx- Dose Level 2|once weekly dosing for 26 weeks
16041731|NCT02583919|Drug|Placebo|once weekly dosing for 26 weeks
16041732|NCT02583906|Device|CPAP|Treatment with CPAP for six months in the CPAP arm.
16041733|NCT02583893|Drug|Sirolimus|Given PO
16041734|NCT02583893|Drug|Mitoxantrone|Given IV
16041735|NCT02583893|Drug|Etoposide|Given IV
16041736|NCT02583893|Drug|Cytarabine|Given IV
16041737|NCT02583867|Behavioral|Exercise|Subjects will engage in supervised exercise sessions for 12 weeks. Each week will consist of at least three exercise sessions with a total duration of weekly exercise of approximately 150 minutes.
16041738|NCT02583854|Device|RY-STOP hemostasis device|
16041739|NCT02583854|Device|TR-Band, Terumo|
16041740|NCT02583841|Procedure|Scaling and root planing|scaling and root planing as an intervention was done in patients of the test group
16041741|NCT02583828|Drug|Cyclophosphamide 50mg|
16041742|NCT02583828|Drug|Letrozole 2.5 mg|
16041743|NCT02583802|Drug|Ear pills|The clinical design of this study was a randomized crossover trial. This experiment research is divided into two stages, each stage is 8 weeks. After 4 weeks after a washout period, two groups of cross accept the next phase of treatment.
16041744|NCT02583802|Drug|Shengmai capsule|The clinical design of this study was a randomized crossover trial. This experiment research is divided into two stages, each stage is 8 weeks.
16041745|NCT02583789|Drug|oral treprostinil|Change in the Raynaud's Condition Score from baseline (2-week run in), comparing treprostinil treatment phase vs. placebo phase
16041746|NCT02583789|Drug|Placebo|Placebo is a sugar pill manufactured to resemble UT-15C. Change in the Raynaud's Condition Score from baseline (2-week run in), comparing treprostinil treatment phase vs. placebo phase
16041747|NCT02583776|Device|Unblinded - CGM|Data from device will be readable and alarms on
16041748|NCT02583776|Device|Blinded - CGM|Data from device will be blinded and alarms off
16041749|NCT02583763|Other|Echocardiography|During the ultrasound examinations standardized, moving sequences of the heart will be saved. Analyzes are performed off-line and analyzed by vector velocity imaging software.
16041750|NCT02583763|Procedure|Blood sample|The investigators will take a blood sample from the umbilical cord at birth and again at 7 years of age.
16041751|NCT02583750|Behavioral|OGTT after deprived sleep first|Participants slept 1-3 hours less than their normal amount for three nights, and then came to the lab for the oral glucose tolerance testing after a 12 hour overnight fast. The second oral glucose tolerance test was after they slept as much as they wanted for three nights.
16041752|NCT02583750|Behavioral|OGTT after sufficient sleep first|Participants slept as much as they wanted for three nights, and then came to the lab for the oral glucose tolerance testing after a 12 hour overnight fast. The second oral glucose tolerance test was after they slept 1-3 hours less than normal for three nights.
16041753|NCT02583737|Procedure|freeze bone allograft|sinus lifting filling procedure employing freeze bone allograft from tissue bone bank.
16041754|NCT02583737|Procedure|lyophilized bone allograft|sinus lifting filling procedure employing lyophilized bone allograft from tissue bone bank.
16041755|NCT02583711|Device|Activity sensor (3 axis accelerometer)|Patient cohort will wear the activity sensor from pre-admission clinic until discharge after surgical procedure
16041756|NCT02583698|Drug|Carvedilol|
16041757|NCT02583698|Drug|Placebo|
16041758|NCT02583685|Drug|PR4 + LDV/SOF + ASV 4 wk|Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Asunaprevir (ASV) 200mg administered orally twice daily.
16041759|NCT02583685|Drug|PR4 + LDV/SOF + SMV 4 wk|Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily.
16041760|NCT02583685|Drug|PR4 + LDV/SOF + ASV 6 wk|Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Asunaprevir (ASV) 200mg administered orally twice daily.
16041761|NCT02583685|Drug|PR4 + LDV/SOF + SMV 6 wk|Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily.
16041762|NCT02583685|Drug|PR4 + LDV/SOF + ASV 8 wk|Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Asunaprevir (ASV) 200mg administered orally twice daily.
16041805|NCT02583386|Behavioral|Free From Falls fall prevention program|Eight-week education and exercise program, intended to reduce falls in people with Multiple Sclerosis.
16041763|NCT02583685|Drug|PR4 + LDV/SOF + SMV 8 wk|Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily.
16041764|NCT02583685|Drug|PR4 + LDV/SOF + ASV 12 wk|Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Asunaprevir (ASV) 200mg administered orally twice daily.
16041765|NCT02583685|Drug|PR4 + LDV/SOF + SMV 12 wk|Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection; Ribavirin (RBV) administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg); Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily.
16041766|NCT02583672|Drug|N-acetylcysteine|1800mg NAC twice daily (3600mg/day) orally for approximately 90 days.
16041767|NCT02583633|Drug|Transdermal nitroglycerin|
16041768|NCT02583633|Drug|nifedipine|
16041769|NCT02583620|Genetic|blood sample|A blood test is realized on the subject
16041770|NCT02583607|Device|Brava|"The purpose of the study is to examine the efficacy of Brava with fat grafting in woman undergoing mastectomy in the institution.
~woman who will agree to participate in the study will be instructed how to wear the Brava, and after 200 hours of using the device they will be operated for fat transfer to the breast in order to reconstruct it."
16041771|NCT02583594|Drug|Acyclovir|Pharmaceutical form:tablet Route of administration: oral
16041772|NCT02583594|Drug|Methylprednisolone|Pharmaceutical form:tablet Route of administration: oral
16041773|NCT02583594|Drug|alemtuzumab GZ402673|Pharmaceutical form:solution for infusion Route of administration: intravenous
16041774|NCT02583594|Drug|alemtuzumab GZ402673|Pharmaceutical form:injection Route of administration: subcutaneous
16041775|NCT02583594|Drug|Paracetamol|Pharmaceutical form:tablet Route of administration: oral
16041776|NCT02583594|Drug|Loratadine|Pharmaceutical form:tablet Route of administration: oral
16041777|NCT02583594|Drug|Ceterizine|Pharmaceutical form:tablet Route of administration: oral
16041778|NCT02583594|Drug|Dexchlorpheniramine|Pharmaceutical form:tablet Route of administration: oral
16041779|NCT02583581|Device|EEG monitoring (MindWave by NeuroSky)|EEG evaluation will be conducted for duration of 10 minutes. 5 minutes without auditory stimulation and 5 minutes with auditory stimulation performed using standard headphone or earphones to reduce external noises.
16041780|NCT02583581|Device|EEG monitoring (EPOC by Emotiv)|EEG evaluation will be conducted for duration of 10 minutes. 5 minutes without auditory stimulation and 5 minutes with auditory stimulation performed using standard headphone or earphones to reduce external noises.
16041781|NCT02583568|Drug|Bevacizumab-800CW|three days prior to surgery bevacizumab-800CW will be administered
16041782|NCT02583555|Behavioral|Interview followed by frequent telephone support|Interview followed by telephone support
16041783|NCT02583542|Drug|AZD2014|AZD2014 is a dual inhibitor of both mTORC1 (rapamycin-sensitive) and mTORC2 (rapamycin insensitive); compared to rapalogues, AZD2014 has a broader range of growth inhibitory activity in preclinical models based on a more profound mTORC1 inhibition and the additional inhibition of mTORC2. AZD2014 is currently in phase 2 studies in renal cell cancers and metastatic breast cancer.
16041784|NCT02583542|Drug|AZD6244|Selumetinib (AZD6244, ARRY-142886) is an orally available, potent, selective, non-ATP competitive inhibitor of MEK1/MEK2 kinases. Selumetinib has demonstrated clinical efficacy in pre-treated KRAS-mutant NSCLC, leading to a significantly improved progression-free survival in combination with docetaxel compared to docetaxel alone.
16041785|NCT02583529|Device|Back Tibial Nerve Electrostimulation|The BTNE will be made with electrodes Silver Spike Point (SSP) set in an ankle with the negative pole positioned on the inner malleolus and the positive approximately 05 cm below the previous, and connected to a portable stimulator powered by rechargeable battery developed by the Biomedical Engineering Department of the HCPA.
16041786|NCT02583529|Device|Placebo Electrostimulation|The BTNPE will be made with electrodes Silver Spike Point (SSP) set in an ankle with the negative pole positioned on the inner malleolus and the positive approximately 05 cm below the previous, and connected to a portable stimulator powered by rechargeable battery developed by the Biomedical Engineering Department of the HCPA.
16041787|NCT02583516|Drug|vemurafenib and cobimetinib|Comparison between different treatment regimens
16041788|NCT02583503|Radiation|Hindfoot alignment view x ray|Diagnostic x rays used to measure leg alignment.
16041789|NCT02583490|Device|spectrum 5000Q ECT device (RUL ECT)|
16041790|NCT02583490|Device|spectrum 5000Q ECT device (RUL LAP ECT)|
16041791|NCT02583477|Drug|MEDI4736 in combination with nab-paclitaxel and gemcitabine|MEDI4736 in combination with nab-paclitaxel + gemcitabine chemotherapy regimen via IV infusion
16041792|NCT02583477|Drug|MEDI4736 in combination with AZD5069|MEDI4736 via IV infusion and oral AZD5069
16041793|NCT02583464|Drug|Tenofovir disoproxil fumarate and emtricitabine|Two period administration of a formulation containing a combination of emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg.
16041794|NCT02583451|Drug|Placebo tablet matching lemborexant|Tablet form taken orally at bedtime.
16041795|NCT02583451|Drug|Placebo tablet matching zopiclone|Tablet form taken orally at bedtime.
16041796|NCT02583451|Drug|Zopiclone 7.5 mg|7.5 mg tablet taken orally at bedtime.
16041797|NCT02583451|Drug|Lemborexant 2.5 mg|2.5 tablet taken orally at bedtime.
16041798|NCT02583451|Drug|Lemborexant 5 mg|5 mg tablet taken orally at bedtime.
16041799|NCT02583451|Drug|Lemborexant 10 mg|10 mg tablet taken orally at bedtime.
16041800|NCT02583438|Drug|Saxagliptin (Bristol-Myers Squibb Company)|6-month treatment of Saxagliptin 5mg Qd
16041801|NCT02583425|Drug|DFN-11 Injection|
16041802|NCT02583412|Biological|Bexsero®|Multicomponent meningococcal B vaccine
16041803|NCT02583412|Biological|Havrix®|Hepatitis A vaccine
16041804|NCT02583399|Drug|Ibuprofen|Ibuprofen, 10 mg/kg
16043475|NCT02571842|Drug|Intravenous Rituximab|- 375 mg/m2 rituximab be prescribed 4 consecutive monthly
16041806|NCT02583386|Other|Electronic Fall Detector|30 participants will be randomly selected to wear an electronic fall detector during the first 10 weeks of study participation. This fall detector will automatically record any falls occurring while worn.
16041807|NCT02583373|Drug|CAL02 Low-dose|Two doses of CAL02 (low-dose) administered 2 times (24 hours apart) as i.v. infusion
16041808|NCT02583373|Drug|CAL02 High-dose|Two doses of CAL02 (high-dose) administered 2 times (24 hours apart) as i.v. infusion
16041809|NCT02583373|Drug|Placebo|Placebo administered administered 2 times (24 hours apart) as i.v. infusion
16041810|NCT02583360|Diagnostic Test|Combined testing (diagnostic VFSS + research HRM) + Parent Preferred Therapy|Addition of research HRM along with diagnostic VFSS with parental choice of therapy
16041811|NCT02583347|Device|Vivia Home Hemodialysis System|The cohort of interest is those patients performing nocturnal home hemodialysis using the Vivia Home Hemodialysis System for 8 hours, 5 nights per week
16041812|NCT02583334|Device|Verum acupuncture (30# acupuncture needle)|Acupuncture will be applied by inserting acupuncture needle into acupoints (LI4, LI11, LR3, ST36, SP6, GB34)
16041813|NCT02583334|Device|Sham acupuncture|Streitberger device will be applied by onto acupoints (LI4, LI11, LR3, ST36, SP6, GB34). The device will not really insert the blunt needle into skin but let the participants feel like real acupuncture (Lancet 1998; 352: 364-365.).
16041814|NCT02583321|Device|Endotracheal tubes not allowing SSD|In the participating center, a bundle of Ventilator-Associated Pneumonia (VAP) prevention will be applied: elevate the head of the bed to 30°-45°, regular oral care, manage patients with sedation algorithm, assess readiness to extubate daily, intermittent control of endotracheal tube cuff pressure
16041815|NCT02583321|Device|Endotracheal tubes allowing SSD|"In the participating center, a bundle of VAP prevention will be applied: elevate the head of the bed to 30°-45°, regular oral care, manage patients with sedation algorithm, assess readiness to extubate daily, intermittent control of endotracheal tube cuff pressure.
~In addition, SSD will be realized using a 10 ml syringe at in attending frequency of 2 hours."
16041816|NCT02583308|Device|Endotracheal tubes not allowing SSD|In each participating center, a bundle of VAP prevention will be applied: elevate the head of the bed to 30°-45°, regular oral care, manage patients with sedation algorithm, assess readiness to extubate daily, intermittent control of endotracheal tube cuff pressure
16041817|NCT02583308|Device|Endotracheal tubes allowing SSD|"In each participating center, a bundle of VAP prevention will be applied: elevate the head of the bed to 30°-45°, regular oral care, manage patients with sedation algorithm, assess readiness to extubate daily, intermittent control of endotracheal tube cuff pressure.
~In addition, SSD will be realized using a 10 ml syringe at in attending frequency of 2 hours."
16041818|NCT02583295|Behavioral|Music sound|The recorded preferred songs or music (commercially available) listened by CD player connected to the patient ears before induction of anesthesia and continued during intra operative period
16041819|NCT02583295|Behavioral|Maternal sound|The recorded maternal voice (while they are singing the most popular songs their children like or telling a story to help their children to sleep) listened by CD player connected to the patient ears before induction of anesthesia and continued during intra operative period
16041820|NCT02583282|Other|Doxycycline|500 mg of doxycycline will be dissolved in 50 ml of normal saline. The combination will then be instilled through the chest tube in the pleural cavity and the chest tube drain will be clamped for 4 hours.
16041821|NCT02583282|Other|Iodopovidine|20 ml of 10% betadine (Microshield, Johnson and Johnson, Solan, India) will be dissolved in 80 mL of normal saline. The combination will then be instilled through the chest tube in the pleural cavity and the chest tube drain will be clamped for 4 hours.
16041822|NCT02583269|Diagnostic Test|Laboratory Biomarker Analysis|Correlative studies
16041823|NCT02583269|Drug|Muscadine Grape Skin Extract|Given PO
16041824|NCT02583269|Procedure|Quality-of-Life Assessment|Ancillary studies
16041825|NCT02583256|Biological|Adjuvanted QIV (aQIV)|Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
16041826|NCT02583256|Biological|Non-adjuvanted QIV|Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
16041827|NCT02583243|Behavioral|MET/CBT based individualized counseling|Manualized counseling with the first four week being MET followed by 8 weeks of CBT
16041828|NCT02583243|Drug|Buprenorphine|Target dose in stabilization is 16 mg of buprenorphine to be taken sublingually once daily.
16041829|NCT02583230|Behavioral|MedLink System|"Patient adherence to anti depressant medication will be accomplished by 1) monitoring adherence and providing feedback to patient (e.g. prompting patient to take medication); 2) monitoring side effects and treatment response and providing in-the-moment feedback and support; 3) activating the patient to take appropriate action (e.g. call the prescribing physician) based upon monitoring data; 4) providing standardized education and positive reinforcement to the patient.
~The care team will be supported and activated by being provided 1) suggested guideline-congruent actions and 2) timely information regarding the patient's status."
16041830|NCT02583217|Drug|Ketamine|To compare ketamine+propofol versus remifentanyl+propofol to maintain good laryngeal mask insertion conditions
16041831|NCT02583217|Drug|remifentanyl|
16041832|NCT02583217|Drug|propofol|
16041833|NCT02583217|Device|laryngeal mask|
16041834|NCT02583204|Device|Onicolife nail drops|The prescription free, CE (Conformité Européenne) marked product is for local application, and has a novel mode of action involving the modulation of mast cell action with the fatty acid amide, Adelmidrol ®. Mast cells are known to have a key role in the ability of the body to promote healing /repair and control tissue damage caused by chemo and radiotherapy. This includes damage to the nail and/ or nail matrix. OnicoLife ® thus helps to control inflammation and pain whilst antimicrobial action also provides antibacterial and antifungal support.
16041835|NCT02583204|Other|Nail polish|One dark colour of nail polish (deep burgundy/red) will be used in this study since this colour is considered more acceptable to many more women than a pure black coloured nail polish and hence, more likely to ensure compliance. No nail polish containing hardeners will be used since there is some evidence to suggest they can induce nail changes. As dark nail polish can stain the nail plate (and therefore mask any changes in nail pigmentation induced by chemotherapy), one clear base coat, two coats of coloured, and one clear top coat of polish will be required for each application. This standard of application is proposed as a gold standard for the prevention of nail staining and hypersensitivity reactions by an eminent podiatrist (Spalding, 2008).
16041836|NCT02583191|Drug|Rivaroxaban|Rivaroxaban 15 mg twice daily for 21 days, followed by 20 mg once daily over a period of 3 months
16041837|NCT02583191|Drug|low-molecular heparine|"LMWH in therapeutic dosage (1-2× daily s.c.) according to standards of the individual study center, using licensed dosages, e.g.
~Enoxaparin 1 mg/kg BW twice daily
~Tinzaparin 175 I.E./kg BW once daily
~Dalteparin 200 I.E./kg BW once daily"
16041838|NCT02583178|Device|Aegis Sierra Ligation System|The SLS is a series of devices designed for epicardial ligation of the left atrial appendage through a minimally invasive transcatheter approach.
16041839|NCT02583165|Biological|MEDI1873|Subjects will receive MEDI1873 by intravenous administration
16041840|NCT02583139|Behavioral|Designed Music Narratives|"Four music narratives for children each comprising an introductory relaxation exercise, a resource-oriented narrative including guided imagery suggestions and relaxing nature scenarios plus especially composed music.
~The narrative and music reflect and support each other."
16041841|NCT02583126|Behavioral|Guided Imagery and Music|Modified and resource-oriented form of the Bonny Method of Guided Imagery and Music (BM-GIM)
16041843|NCT02583100|Behavioral|Intensive Feedback|(1) receive feedback regarding their individual fistula rate and those of all other participants in the trial, (2) receive an analysis of their video-recorded operative technique by surgeon peers, (3) directly observe a peer surgeon with lower fistula rate, and (4) develop a personalized action plan with a target for improvement.
16041844|NCT02583100|Behavioral|Routine Feedback|(1) receive feedback regarding their individual fistula rate and those of all other participants in the trial
16041845|NCT02583087|Procedure|endoscopic submucosal dissection|Endoscopic resection of a superficial neoplastic lesion of the esophagus, including the mucosal and the submucosa resected en bloc.
16041846|NCT02583074|Procedure|Stimulation|After surgery, patients in 'Neurostimulation Group' will receive subthalamic nucleus stimulation for 3 months.
16041847|NCT02583074|Procedure|Sham-stimulation|After surgery, patients in 'sham-stimulation Group' will receive subthalamic nucleus sham-stimulation for 3 months.
16041848|NCT02583061|Other|There is no intervention. An exposure of interest is glucose tolerance status in pregnancy|
16041849|NCT02583048|Drug|Bedaquiline|Four 100 mg tablets (400 mg) orally once a day for 2 weeks, followed by two 100 mg tablets (200 mg) orally three times a week for 22 weeks.
16041850|NCT02583048|Drug|Delamanid|Two 50 mg tablets (100 mg) orally with food twice a day for 24 weeks.
16041851|NCT02583048|Drug|Dolutegravir|For HIV-positive participants only: one 50 mg tablet orally once daily, to be used in combination with two NRTIs until study completion. (NRTIs were not provided by the study.)
16041852|NCT02583048|Drug|Multidrug Background Treatment (MBT) for TB|A standardized MBT regimen for MDR- or RR-TB except in cases where a participant had known resistance to one of the components of local standard treatment. MBT was provided by the local program.
16041853|NCT02583035|Other|Nurse telephone contact|Nurse will contact patient 3 days before consultation
16041854|NCT02583022|Drug|PAC-14028 cream 1.0%|Topical application
16041855|NCT02583022|Drug|PAC-14028 cream vehicle|Topical application
16041856|NCT02583022|Drug|Elidel cream 1%|Topical application
16041857|NCT02583009|Drug|PAC-14028 cream 0.1%|Topical application
16041858|NCT02583009|Drug|PAC-14028 cream 0.3%|Topical application
16041859|NCT02583009|Drug|PAC-14028 cream 1.0%|Topical application
16041860|NCT02583009|Drug|PAC-14028 cream vehicle|Topical application
16041861|NCT02582996|Drug|Acetaminophen+Caffeine+Dihydroergotamine+Metoclopramide.|The subject must manage 02 tablets of Cefalium right after a moderate to severe migraine.
16041862|NCT02582996|Drug|Acetaminophen|The subject must manage 02 tablets of Tylenol right after a moderate to severe migraine.
16041863|NCT02582983|Drug|Enfuvirtide|All participants received enfuvirtide 90 mg SC BID until 4 weeks after commercial availability was established in Thailand.
16041864|NCT02582970|Drug|5-Fluorouracil|Intravenous 5-fluorouracil based chemotherapy will be administered until disease progression or until termination of the study. The chemotherapy regimen will be at the discretion of the prescriber and will not be provided by the sponsor.
16041865|NCT02582970|Drug|Bevacizumab|Bevacizumab will be administered IV 5 mg/kg every 2 weeks until disease progression or until termination of the study.
16041866|NCT02582970|Drug|Irinotecan|Irinotecan will be administered at the discretion of the prescriber until disease progression or until termination of the study.
16041867|NCT02582970|Drug|Oxaliplatin|Oxaliplatin will be administered at the discretion of the prescriber until disease progression or until termination of the study.
16041868|NCT02582957|Other|Sigh breaths|Sigh breaths delivered once every 6 minutes, as part of usual invasive mechanical ventilation.
16041869|NCT02582944|Device|Olympus BF-180 bronchoscope (standard adult)|-Standard of care
16041870|NCT02582944|Device|Veran Spinview Thoracic Navigation System|-Electromagnetic navigation
16041871|NCT02582944|Device|Olympus UM-S20-17S|-Endobronchial ultrasound mini-probe
16041872|NCT02582944|Procedure|Biopsy|
16041873|NCT02582931|Device|MRI-guided SBRT|
16041874|NCT02582931|Behavioral|EORTC QLQ-C30 Questionnaire|30 questions with 28 questions having answers that range from 1 (not at all) to 4 (very much) and the other 2 questions have answers that range from 1 (very poor) to 7 (excellent)
16041875|NCT02582931|Behavioral|EORTC QLQ-OV28 Questionnaire|28 questions having answers that range from 1 (not at all) to 4 (very much)
16041876|NCT02582918|Behavioral|Outreach with patient education and patient navigation services|"Outreach invitations include number to call for more information about scheduling an ultrasound and alpha fetoprotein (AFP) blood test.
~Patients receive up to three phone calls 2-4 weeks after invitations and a reminder call 5-7 business days before appointments.
~If results are normal, the patient is invited to repeat screening in 6 months.
~If suspicious mass on ultrasound or abnormal AFP level, the patient is referred for follow-up testing with triple-phase CT scan or MRI.
~If CT/MRI is unremarkable, the patient is referred back for routine screening.
~If HCC is confirmed, the patient and their primary care provider will be contacted with the results.
~All patients diagnosed with HCC will be seen in the multi-disciplinary HCC clinic."
16041877|NCT02582905|Drug|Placebo|Inactive ingredient matching the active comparators in appearance.
16041878|NCT02582905|Drug|Citicoline|Citicoline is an over-the-counter nutritional supplement that is used for neuroprotective effects. It is a naturally occurring neurochemical in the human body.
16041879|NCT02582905|Drug|Pregnenolone|Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and also in the brain. Pregnenolone produces other neuroactive steroids.
16041880|NCT02582892|Drug|Vit D|20 mg/day
16041881|NCT02582866|Drug|Lacosamide|"Pharmaceutical Form: Oral tablets
~Concentration: 50 mg
~Route of Administration: Oral administration"
16041882|NCT02582853|Procedure|Lumbar puncture|Lumbar puncture for spinal fluid
16041883|NCT02582853|Procedure|Blood Sample|Blood sample
16041884|NCT02582840|Drug|Dapagliflozin 5mg|Dapagliflozin, a blood glucose lowering drug. Oral dose
16041885|NCT02582840|Drug|Dapagliflozin 10mg|Dapagliflozin, a blood glucose lowering drug. Oral dose
16041886|NCT02582840|Drug|Placebo tablet|Placebo tablet. Oral dose
16041887|NCT02582827|Drug|ABI-011|ABI-011 is a novel, albumin-bound formulation of a potent thiocolchicine analog, IDN 5404, with a mean particle size of approximately 100 nm.
16041888|NCT02582814|Drug|Dapagliflozin 5 mg|Dapagliflozin, a blood glucose lowering drug. Oral dose
16041889|NCT02582814|Drug|Dapagliflozin 10mg|Dapagliflozin, a blood glucose lowering drug. Oral dose
16041890|NCT02582801|Drug|18F-Alfatide Ⅱ PET/CT|Inject 18F-Alfatide Ⅱ by vein and then perform PET/CT scan after 60 min
16041891|NCT02582788|Other|Bathing Additive|
16041892|NCT02582775|Drug|Thymoglobulin|0.5 mg/kg IV over 6 hours on day -9 and 2 mg/kg IV over 4 hours on day -8 and day -7 with premeds and solumedrol through day -2
16041893|NCT02582775|Drug|Cyclophosphamide|14.5 mg/kg IV over 1 hour day -6 and -5 50 mg/kg IV over 2 hours with mesna 40 mg/kg IV day +2 and +3
16041894|NCT02582775|Drug|Fludarabine|30 mg/m2 IV over 60 minutes days -6 through day -2
16041895|NCT02582775|Radiation|Total Body Irradiation|See arm description for dosing.
16041896|NCT02582775|Procedure|Bone marrow infusion|Bone marrow infusion on Day 0
16041897|NCT02582775|Drug|Tacrolimus|Day +5 through day +100 with goals of 5-10 ug/L (not used for HLA-identical related donors)
16041898|NCT02582775|Drug|Mycophenolate Mofetil|15 mg/kg IV q8h (based upon actual body weight) with the maximum total daily dose not to exceed 3 grams. Day +5 through day 35
16041899|NCT02582775|Biological|Donor mesenchymal stem cell infusions|Day 60, 100 and 180 (collected during donor BM harvest for graft)
16041900|NCT02582775|Drug|Busulfan|busulfan IV over 3 hours on days -3 and -2 for HLA-mismatched BM recipients only (Arms F and G)
16041901|NCT02582762|Drug|Nail gel|apply nail gel on affected nails twice daily for 2 months
16041902|NCT02582749|Drug|LHRH agonist/antagonist|Treating physician will determine LHRH agonist/antagonist, dosage and route of administration, per package insert, during each 28-day cycle.
16041903|NCT02582749|Drug|Bicalutamide|Bicalutamide, 50 mg Oral (PO) will be administered daily in each 28-day cycle.
16041904|NCT02582749|Radiation|Radium-223 dichloride|Radium-223 dichloride, 50 kBq (1.35 microcurie) per kg body weight intravenous (IV bolus) every 28 days for 6 injections
16041905|NCT02582736|Drug|Olanzapine|Exposure to olanzapine (ATC N05AH03) will be defined as a prescription for olanzapine on the date of cohort entry.
16041906|NCT02582736|Drug|Risperidone|Exposure to risperidone (ATC N05AX08) will be defined will be defined as a prescription for risperidone on the date of cohort entry.
16041907|NCT02582736|Drug|atypical antipsychotics (other)|Exposure to other atypitical antipsychotics (ATC N05AH02, N05AH04, N05AE04, N05AX13, N05AX12) will be defined will be defined as a prescription for an atypical antipsychotic other than olanzapine on the date of cohort entry.
16041908|NCT02582736|Drug|typical antipsychotics|Exposure to typical antipsychotics (M03BB02, N05AA01, N05AF03, N05AF01, N05AB02, N05AG01, N05AD01, N05AA02, N05AH01, N05AC03, N05AB03, N05AG02, N05AC04, N07XX06, N05AB05, N05AB08, N05AC02, N05AF04, N05AB06, N05AF05) will be defined as a prescription for a typical antipsychotic on the date of cohort entry.
16041909|NCT02582723|Other|High protein/high fat hard cheese|Assess whether the cheeses with high protein content have improved effect on satiety compared to the cheese with low protein content.
16041910|NCT02582723|Other|High protein/low fat hard cheese|Assess whether the cheeses with high protein content have improved effect on satiety compared to the cheese with low protein content.
16041911|NCT02582723|Other|Low protein/high fat creme cheese|Assess whether the cheeses with high protein content have improved effect on satiety compared to the cheese with low protein content.
16041912|NCT02582710|Dietary Supplement|VASCAZEN|6 weeks treatment with an optimized formulation of omega 3 before the carotid endarterectomy
16041913|NCT02582710|Dietary Supplement|PLACEBO|6 weeks treatment with a placebo before the carotid endarterectomy
16041914|NCT02582697|Drug|Bleomycin (active name: Bleomycin Sulfate)|"Standard Arm: Bleomycin 30,000 international units IV weekly for 3 doses (eg. days 1, 8 and 15 or days 2, 9 and 16 of a 21-day cycle) for 4 cycles.
~Accelerated Arm: Bleomycin 30,000 international units IV weekly for 2 doses (eg. days 1 and 8 or days 2 and 9 of a 14-day cycle) for 4 cycles. Followed by Bleomycin 30,000 international units IV weekly for 4 doses."
16041915|NCT02582697|Drug|Etoposide|"Standard Arm: Etoposide 100 mg/m2 IV on days 1, 2, 3, 4, 5 of a 21-day cycle for 4 cycles.
~Accelerated Arm: 100 mg/m2 IV on days 1, 2, 3, 4, 5 of a 14-day cycle for 4 cycles."
16041916|NCT02582697|Drug|Cisplatin|"Standard Arm: Cisplatin 20 mg/m2 IV on days 1, 2, 3, 4, 5 of a 21-day cycle for 4 cycles.
~Accelerated Arm: Cisplatin 20 mg/m2 IV on days 1, 2, 3, 4, 5 of a 14-day cycle for 4 cycles."
16041917|NCT02582697|Drug|Pegylated G-CSF (Pegfilgrastim)|Standard Arm: 6 mg SCI on day 6 of a 21-day cycle for 4 cycles. Accelerated Arm: 6 mg SCI on day 6 of a 14-day cycle for 4 cycles.
16041918|NCT02582697|Drug|Filgrastim|"Standard Arm: 10 mcg/kg/day on day6, until post-nadir absolute neutrophil count ≥ 1.0 x 10^9/L, of a 21-day cycle for 4 cycles.
~Accelerated Arm: 10 mcg/kg/day on day 6, until post-nadir absolute neutrophil count ≥ 1.0 x 10^9/L, of a 14-day cycle for 4 cycles."
16041919|NCT02582684|Drug|Dolutegravir|Participants were prescribed 50 mg of DTG orally daily
16041920|NCT02582684|Drug|Lamivudine|Participants were prescribed 300 mg of 3TC orally daily.
16041921|NCT02582671|Drug|Ombitasvir/paritaprevir/ritonavir|Co-formulated tablet
16041922|NCT02582671|Drug|Dasabuvir|Tablet
16041923|NCT02582671|Drug|Ribavirin|Tablet
16041924|NCT02582645|Procedure|open window technique|palatally impacted canine will be exposed and left without traction for a maximum of 9 months
16041925|NCT02582645|Procedure|closed window technique|palatally impacted canine will be exposed, an attachment will be bonded, and then the canine will be covered with palatal tissue; traction of the canine will be initiated within 2 weeks following surgery
16041926|NCT02582632|Drug|ombitasvir/paritaprevir/ritonavir|Tablet
16041927|NCT02582632|Drug|dasabuvir|Tablet
16041929|NCT02582606|Other|Regular meal pattern|a 14-day period of eating 6 meal per day
16041930|NCT02582606|Other|Irregular meal pattern|a 14-day period of eating between 3 and 9 meal per day
16041931|NCT02582593|Device|MedX 1116 Rehab Console|This intervention makes use of transcranially applied near infrared light using light emitting diodes. Near infrared light will be applied to the scalp for a period of 1 hour at each session. A total of six session will be held.
16041932|NCT02582593|Device|Sham MedX 1116 Rehab Console|This intervention makes use of sham transcranially applied near infrared light using light emitting diodes. Light emitting diodes (but not near-infrared light) will be applied to the scalp for a period of 1 hour at each session. A total of six session will be held.
16041933|NCT02582580|Other|Perineal massage|"Perineal massage should be practiced once a day, from the 34th week of gestation until the beginning of labor. It should obey the following sequence: the pregnant woman must be positioned comfortably and use intimate water based lubricant at her fingertips; start the massage in the outdoor area of the vulva with circular movements of the skin and connective tissue around the vagina and at the central tendon of the perineum, clockwise, clitoris to clitoris; introduce two thumb fingers or index and middle fingers into the vagina at a distance of approximately 4 centimeters; perform internal massaging with laterally semicircles towards the anus for 20 to 30 seconds; put pressure down towards the anus and to each side of the vagina until feeling a slight burning or stretching sensation and hold the position for 2 minutes; massage the lower half of the vaginal introitus in a movement simulating the letter U. All movements should be repeated four times."
16041934|NCT02582580|Device|Vaginal Dilator|Vaginal dilator Epi-No® should be used once a day for 15 minutes, from the 34th week of pregnancy until the beginning of labor. It should be coated with a condom and intimate water based lubricant and then be inserted into the vaginal canal in such way that the balloon stays two centimeters away from the vaginal introitus. The device will be inflated by manual pumping until the tolerable woman's limit. The pregnant woman will be encouraged to daily inflate a greater volume of compressed air into the balloon so that the amount of air is greater than the quantity in the previous day, achieving, day after day, a greater stretching of perivaginal structures, always respecting the individual tolerance limit. The amount of manual pumping imposed to inflate the balloon should be written in an Intervention Diary so that the next use, the pregnant woman will be sure that pumped the device more times than in the previous session.
16041935|NCT02582580|Other|Pelvic floor muscles training|Pregnant women allocated to this group will perform pelvic floor muscles training. The progression of the protocol of this study will occur gradually in view of the peculiarities that involve the pelvic floor in the gestational stage and the ultimate goal is the promotion of an intact perineum after vaginal delivery. The exercises will obey a sequence, according to the gestation week, considering the following factors/parameters: exercise position, number and sustaining period of slow and fast contractions, and relaxation time between contractions. All contractions should be during the expiratory phase of breathing associated with an isometric contraction of the abdominal muscles and at the end of each series of contractions, perform a one minute interval between sets and in that time perform the diaphragmatic breathing exercise to promote overall relaxation. This protocol should be practiced once a day, every day from the 34th week of gestation until the beginning of labor.
16041936|NCT02582567|Other|Exercise intervention|The exercise intervention will be performed in two groups so that each group will have 12-13 participants.The groups will train 3 days/week (60min per session) from the 16th week of gestation until delivery. The exercise intervention group will go through different phases of training: a) Learning phase: which will involve the intervention plan, the goals we want to work, and how we will perform it; b) Movement Learning phase: theoretical and practical sessions with the explanation of movements and ergonomic basic patterns; and c) Physical Fitness Training phase: with training sessions aimed at improving fitness and weight loss, and training sessions focused on a correct pelvic mobilization for the delivery.The intensity will be adapted during the exercise program based on the week of gestation and each pregnant heart rate. The sessions will consist of a mixed work, composed of circuits where both muscular and cardiovascular conditioning will be implemented.
16041937|NCT02582554|Behavioral|NutriSTEP|Provision of nutrition risk screening with NutriSTEP (a nutrition risk screening questionnaire for preschoolers) and nutrition education with NutriSTEP related materials
16041938|NCT02582541|Procedure|SEMS alone|The SEMS (Wallstent, Boston Scientific, USA) would be placed.
16041939|NCT02582541|Procedure|SEMS plus radiofrequency ablation|The RFA catheter has an 8 F bipolar probe and two ring electrodes 8 mm apart with the distal electrode 5 mm from the leading edge, providing local coagulative necrosis over a 2.5 cm length. The catheter is compatible with standard side-viewing endoscopes (3.2 mm working channel), and could be passed over 0.035 inch guidewires. Ablation was performed by using an RFA generator (1500 RF generator; RITA Medical Systems, Fremont, Calif) delivering electrical energy at 400 kHz set at 7-10 W for 90-120 seconds. The RFA energy can be delivered repetitively at different tumor sites within one procedure. After the RFA application is completed, SEMS (Wallstent, Boston Scientific, USA) can be deployed.
16041940|NCT02582528|Behavioral|Cognitive remediation treatment|Cognitive remediation treatment consisting of a novel computerized training called My Brain Solutions (MBS)
16041941|NCT02582528|Behavioral|Motivational Interviewing|A client-centered, directive method for enhancing intrinsic motivation to change.
16041942|NCT02582515|Drug|D-cycloserine|
16041943|NCT02582515|Drug|Placebo|
16041944|NCT02582502|Other|Hyperbaric Oxygen|The only intervention given will be 100% oxygen under hyperbaric pressure.
16041945|NCT02582489|Biological|Bone Marrow Aspirate Concentrate|Subjects undergoing autologous bone marrow aspirate concentrate will receive an intra-articular injection into the affected knee.
16041946|NCT02582489|Procedure|Standard Meniscectomy|All subjects will undergo either a partial or complete meniscectomy to treat the torn meniscus.
16043556|NCT02571231|Device|HFV + and - VG|High frequency ventilation with and without volume guarantuee
16041947|NCT02582476|Drug|Bumetanide|Participants will be randomly assigned to either bumetanide or placebo for the first visit. The assigned treatment will be taken by mouth at the onset of a focal attack defined as 40% decrement in ADM CMAP amplitude compared to the maximum CMAP amplitude recorded during or after the exercise. The second assessment will follow an identical protocol to the first, but with the other treatment administered.
16041948|NCT02582476|Drug|Placebo|Participants will be randomly assigned to either bumetanide or placebo for the first visit. The assigned treatment will be taken by mouth at the onset of a focal attack defined as 40% decrement in ADM CMAP amplitude compared to the maximum CMAP amplitude recorded during or after the exercise. The second assessment will follow an identical protocol to the first, but with the other treatment administered.
16041949|NCT02582450|Other|Patients with haemophilia|Piloting of reliability and validity of the Spanish version of the Veritas-Pro questionnaire.
16041950|NCT02582437|Other|History for opioid use|
16041951|NCT02582424|Other|PD-L0101|92% EPA+6 mg ATX+50 mg TCT GG BID
16041952|NCT02582424|Other|placebo|placebo
16041953|NCT02582411|Device|Laser Speckle Flowgraphy|A commercially available LSFG (Softcare, Fukutsu, Japan) system will be used in the present study. The LSFG device consists of a fundus camera equipped with a diode laser with a wavelength if 830 nm and charge-coupled device. NB, the relative velocity of blood flow, is derived from the pattern of speckle contrast produced by the interference of a laser scattered by blood cells moving in the ocular fundus. Images are acquired continuously at the rate of 30 frames per seconds in a 4-second time period and stored on a personal computer. Heartbeat map of the optic nerve head and the retina/choroid is generated
16041954|NCT02582411|Device|Doppler Optical Coherence Tomography|"A dual-beam bidirectional Doppler OCT system comprises a broadband superluminescent diode (SLD) with a central wavelength of 840 (spectral bandwidth 54 nm) and two CCD cameras with a maximum readout rate of 20 kHz. The system provides a resolution (in tissue) of about 6 and 18 μm in axial and lateral direction, respectively. The sample, i.e. the retinal vessel under study, is illuminated by two probe beams separated by their polarization properties. Light back scattered and backreflected from the sample is spectrally detected by two identical spectrometers and postprocessing, i.e.
~calculation the phase shift due moving scatterers within the sample, is carried out by a personal computer with software written in National Instruments LabView. The power of both probe beams incident on the cornea is 650 μW, which is below the ANSI (American National Standard Institute) limits for small source ocular exposure to a laser beam within the measuring time."
16041955|NCT02582398|Other|Light Therapy|One subgroup of SAD patients and healthy controls respectively will receive bright light therapy using an artificial white light source (PhysioLight LD220 by DAVITA®, www.davita.de/shop/lichttherapiegeraete/lichtduschen-tageslicht/physiolight-ld-220.html) with full-spectrum 10.000lux light intensity. The treatment will be applied 30min per day at a distance of about of 50cm, preferably in the morning, during 3 weeks.
16041956|NCT02582398|Other|Placebo Light|The second subgroup of the SAD patients and healthy controls will receive a non-biologically active light source (<400nm or >500nm). Here, the lamp will have largely similar shape and size as compared to the therapeutic device, but the fluorescent tube with the high light intensity will be replaced by an ordinary bulb.
16041957|NCT02582385|Other|in-situ cytokine expression|
16041958|NCT02582372|Drug|Dexmedetomidine and bupivacaine|10 micrograms of dexmedetomidine plus 12,5 mgrs of bupivacaine subarachnoideal
16041959|NCT02582372|Drug|Fentanyl and bupivacaine|25 micrograms of fentanyl plus 12,5 mgrs of bupivacaine subaracnoideal
16041960|NCT02582359|Drug|MLN9708|Dose of 1.5 mg or 2.3 mg or 3.0 mg taken by mouth on days 2, 5, 9, 12 of each cycle.
16041961|NCT02582359|Drug|Cytarabine|Induction: cytarabine 100 mg/m2/day continuous infusion, days 1-7 Consolidation: cytarabine 2000 mg/m2/day, 3 hour infusion, on days 1-5
16041962|NCT02582359|Drug|Daunorubicin|Daunorubicin 60 mg/m2, IV bolus, on days 1-3 of induction, only.
16041963|NCT02582346|Procedure|MRI acquisition - no contrast agent|No surgery. Volunteers will have an MRI with a 3T clinical system. Installation will be performed according to standard protocols. Different neurography and tractography sequences will be acquired in order to get different contrasts.
16041964|NCT02582333|Other|Observation for clinical and virological changes|Only observation after stopping nucleos(t)ide analogue
16041965|NCT02582320|Drug|Ibrutinib|A longitudinal survey will be carried out by collecting data of patients who received at least 1 dose of Ibrutinib. All patients will be observed for at least 12 months from the treatment start.
16041966|NCT02582307|Drug|Acetaminophen, Analgesics, Non-Narcotic|Oral single dose
16041967|NCT02582307|Drug|Hyoscine butylbromide, Analgesics, Non-Narcotic|Oral single dose
16041968|NCT02582294|Other|Questionnaire|
16041969|NCT02582281|Device|intrauterine device TCu 380A|
16041970|NCT02582268|Device|intrauterine device TCu 380A|
16041971|NCT02582268|Radiation|Trans-abdominal sonography|
16041972|NCT02582255|Biological|Sabin mOPV2|"Polio Sabin™ Mono Two (oral) is a licensed, monovalent, live attenuated poliomyelitis virus vaccine of the Sabin strain Type 2 (P 712, Ch, 2ab), propagated in MRC5 human diploid cells. Each two-drop dose (0.1 mL) contains not less than 105.0 CCID50 of Type 2. Magnesium chloride is used as a stabilizer. Polio Sabin™ Mono Two (Oral) contains trace amounts of neomycin sulphate and polymyxin B sulphate.
~One dose of vaccine (0.1 mL) is contained in two drops which are delivered from the polyethylene dropper supplied with vaccine."
16041973|NCT02582242|Drug|biphasic insulin aspart 30|Administered subcutaneously (s.c., under the skin) thrice daily or twice daily. Subjects will continue with metformin all throughout the trial.
16041974|NCT02582229|Device|Endomina|The intervention will be performed under general anesthesia with tracheal intubation. Endomina will be introduced into the stomach over guide wires and then fixed to the endoscope. The procedure will include the placement of 4-6 transmural anterior-posterior sutures after argon plasma coagulation of the tissue opposition areas in order to ensure persistence of the pouch reduction. Patient will be kept overnight after the procedure.
16042007|NCT02582021|Procedure|Cardiac Magnetic Resonance Angiography|Test for validation purposes against gold-standard Angiography. CMRA is a part of the CMRI test. The residual contrast (gadolinium) circulating in the blood stream (following the CMRI prior images) is sufficient for CMRA evaluation.
16042008|NCT02582021|Procedure|Computed Coronary Tomographic Angiography|Noninvasive, imaging method that uses a computed tomography (CT) scanner to look at the structures and blood vessels of the heart.
16041975|NCT02582216|Device|3D augmented reality|Each treatment period included a 3DARS (3D augmented reality system)training session.All 3DARS training sessions were performed in the same quiet room under the supervision of the same single investigator.The 3DARS training session protocol included two virtual training procedures. The first virtual training procedure consisted of applying a vertical virtual mirror to the display screen, where the non-affected side of the patient's body (such as the right) was symmetrically duplicated by a vertical axis on the affected side (such as the left).The second virtual training procedure consisted of flipping the 3D image horizontally along a vertical axis. This allowed patients to observe the reflection of their non-affected upper extremity as if it was the affected one.
16041976|NCT02582203|Drug|Ceftaroline|
16041977|NCT02582203|Drug|Vancomycin|
16041978|NCT02582190|Drug|Colchicine group|antiarrhythmic therapy plus colchicine & antiarrhythmic therapy alone.
16041979|NCT02582177|Drug|Candicort®|Apply on the affected area and around it twice a day
16041980|NCT02582177|Drug|Nizoral®|Apply on the affected area and around it twice a day
16041981|NCT02582177|Drug|Baycuten N®|Apply on the affected area and around it twice a day
16041982|NCT02582177|Drug|Canesten®|Apply on the affected area and around it twice a day
16041983|NCT02582164|Device|Duke Biomedical Engineering's Long-working distance OCT|The long-distance SSOCT system designed by Duke University Biomedical Engineering Department allows the user to quickly image an eye at a much greater distance (typically 20-40 cm away but this could be longer or shorter). This could potentially be used while briefly attracting a child's attention to an illuminated image over the imaging lens. With this methodology, young patients would not need to place their eye close to the system and could be rapidly imaged during the short interval while they glance at the image from the correct distance.
16041984|NCT02582151|Device|EV-906 Digital Transcutaneous electrical nerve stimulation (TENS) machine|Percutaneous patch electrodes are used to deliver low level electrical currents.
16041985|NCT02582138|Other|Multicomponent intervention (MCI)|"The multicomponent intervention will include physical activity (PA), nutrition and information and communications technology (ICT). The PA will be of moderate intensity and will include aerobic, strength, flexibility, and balance training. Walking will be the primary mode of PA .
~The nutritional intervention will combine individual nutritional assessment and personalised dietary recommendations to achieve:
~a daily total energy intake of 25-30 kcal/kg body weight;
~an average protein daily intake between 1.0 and 1.2 g/Kg/body weight.
~The ICT component will involve the use of an ad hoc technological device to record actimetry data to support the elaboration of a personalised training programme."
16041986|NCT02582138|Other|Healthy Aging Lifestyle Education (HALE)|The healthy aging lifestyle education programme will be based on a workshop series. Participants will receive information on a variety of topics of relevance to older adults (e.g., recommended preventive services and screenings at different ages). The programme will also include a short instructor-led programme (5-10 minutes) of upper extremity stretching exercises or some relaxation techniques that will be performed at the end of each workshop.
16041987|NCT02582125|Drug|ONO-4538|
16041988|NCT02582112|Other|Active Comparator: Warming group|Placebo Comparator: Control group
16041989|NCT02582099|Drug|Gentamicin nasal irrigation|Nasal wash with gentamicin solution
16041990|NCT02582099|Drug|Normal saline nasal irrigation|Nasal wash with normal saline solution
16041991|NCT02582086|Other|BOR15001L7|Active cream with 5% 15019L0
16041992|NCT02582086|Other|Placebo|Placebo Cream with 0% 15019L0
16041993|NCT02582073|Biological|Placebo (0.5ml)|
16041994|NCT02582073|Biological|Placebo (1.0ml)|
16041995|NCT02582073|Biological|Grass MATA MPL (0.5ml) 5100SU|
16041996|NCT02582073|Biological|Grass MATA MPL (1.0ml) 10200SU|
16041997|NCT02582073|Biological|Grass MATA MPL (1.0ml) 18200SU|
16041998|NCT02582073|Biological|Grass MATA (0.5ml) 5100SU|
16041999|NCT02582060|Other|Thromboelastography/Thromboelastometry-Guided Treatment Regimen|The results of the TEG/ROTEM assay (specifically the R time/CT) will be used to determine the prophylaxis treatment regimen.
16042000|NCT02582047|Biological|Influenza vaccination with PPV23|GCflu and Pneumovax-23
16042001|NCT02582047|Biological|Influenza vaccination with PCV13|GCflu and Prevenar-13
16042002|NCT02582034|Radiation|Optimized Internal Radiation Therapy|"Injection of yttrium-90 microspheres (TheraSphere®) is performed during the therapeutic angiogram, directly into the hepatic artery (left or right, or even segmental).
~Optimized dosimetry arm: the activity to be administered is calculated so as to deliver predictive dosimetry:
~An absorbed dose to the tumor of at least ≥ 205 Gy and if possible exceeding 250 Gy or even 300 Gy
~A dose at the treated healthy liver < 120 Gy in case of lobar treatment
~Dose to the treated healthy liver can exceed 120 Gy in case of segmental treatment and hepatic reserve > 30%
~A pulmonary dose < 30 Gy for one treatment and < 50 Gy in cumulative dose in case of multiple treatments."
16042003|NCT02582034|Radiation|Standard Internal Radiation Therapy|"Injection of yttrium-90 microspheres (TheraSphere®) is performed during the therapeutic angiogram, directly into the hepatic artery (left or right, or even segmental).Standard dosimetry arm: the activity to be administered is calculated so as predictive dosimetry:
~An absorbed dose of 120 ± 20 Gy to the treated volume (whatever the tumor absorbed dose)
~A pulmonary dose < 30 Gy for one treatment and < 50 Gy in cumulative dose in case of multiple treatments."
16042004|NCT02582021|Procedure|Coronary Angiography|"A coronary angiogram is a procedure that uses x-ray imaging to see the heart's blood vessels; it is a part of Heart (cardiac) catheterization procedure. During a coronary angiogram, a type of dye that's visible by an x-ray machine is injected into the blood vessels of the heart. The x-ray machine rapidly takes a series of images (angiograms).
~The Coronary Reactivity test (CRT), heart pressure (Millar) evaluation, and Millar stress testing are performed during the coronary angiography."
16042005|NCT02582021|Procedure|Coronary Reactivity Testing|An angiography procedure specifically designed to examine the blood vessels in the heart and how they respond to different medications.
16042006|NCT02582021|Procedure|Cardiac Magnetic Resonance Imaging|"Noninvasive high resolution imaging test; Optimized magnetic resonance imaging technique for use in the cardiovascular system - use of ECG gating and rapid imaging sequences.
~Handgrip, mild leg exercise, and brief Valsalva Maneuver will be conducted to characterize cardiac response to stress. The CMRA is performed as part of the CMRI."
16042217|NCT02580513|Behavioral|Circadian Misalignment|
16044591|NCT02563847|Dietary Supplement|75 g Glucose|
16042009|NCT02582021|Procedure|Rest-Stress Millar Testing|"Handgrip, mild leg exercise, and brief Valsalva Maneuver will be conducted to characterize cardiac response to stress. They are designed to test how your heart muscle is functioning.
~Rest-stress Millar testing is performed during the coronary angiography and Cardiac Magnetic Resonance Imaging."
16042010|NCT02582021|Procedure|Aortic vasorelaxation tests|Non-invasive clinical test. Repeat blood pressure and heart rate per minute will be read for three times; Your pulse wave velocity, pulse wave analysis and central pressure measurements will be recorded.
16042011|NCT02582008|Drug|Bupropion Hydrochloride|Given PO
16042012|NCT02582008|Other|Laboratory Biomarker Analysis|Correlative studies
16042013|NCT02582008|Drug|Nicotine Replacement|Given NRT
16042014|NCT02582008|Other|Quality-of-Life Assessment|Ancillary studies
16042015|NCT02582008|Other|Questionnaire Administration|Ancillary studies
16042016|NCT02582008|Drug|Varenicline|Given PO
16042017|NCT02581995|Drug|Eylea (Aflibercept, VEGF Trap-Eye, BAY86-5321)|2 mg aflibercept administered every 8 weeks following 5 initial monthly doses Intravitreal (IVT) injection
16042018|NCT02581982|Other|Laboratory Biomarker Analysis|Correlative studies
16042019|NCT02581982|Drug|Paclitaxel|Given IV
16042020|NCT02581982|Biological|Pembrolizumab|Given IV
16042021|NCT02581969|Drug|Recombinant Factor VIII (Kogenate FS, BAY14-2222)|Administered 20-30 IU/kg 3 times a week
16042022|NCT02581969|Drug|Recombinant Factor VIII (Kogenate FS, BAY14-2222)|Administered only for bleeding episodes
16042023|NCT02581956|Behavioral|Walking exercise|Walk normally with the duration and frequency at a 30- minute or more daily at least five days per week and gradually increased to a maximum of 60 minutes daily.
16042024|NCT02581956|Behavioral|No walking exercise|no exercise
16042025|NCT02581943|Drug|Carboplatin|Given IV
16042026|NCT02581943|Other|Laboratory Biomarker Analysis|Correlative studies
16042027|NCT02581943|Drug|Paclitaxel|Given IV
16042028|NCT02581943|Biological|Pembrolizumab|Given IV
16042029|NCT02581943|Other|Quality-of-Life Assessment|Ancillary studies
16042030|NCT02581930|Drug|Ibrutinib|Given PO
16042031|NCT02581930|Other|Laboratory Biomarker Analysis|Correlative studies
16042032|NCT02581930|Other|Pharmacogenomic Study|Correlative studies
16042033|NCT02581930|Other|Pharmacological Study|Correlative studies
16042034|NCT02581917|Other|Cytology Specimen Collection Procedure|Undergo collection of PBMC samples
16042035|NCT02581917|Other|Laboratory Biomarker Analysis|Undergo metabolic analysis
16042036|NCT02581904|Device|Prevena Care|The Prevena device is a product from KCI and is a sterile sponge that covers the closed incision. The device is placed sterile in the operating room and suction is then applied to the sponge for 5-7 days.
16042037|NCT02581904|Device|Dry gauze dressing care|Initial dry gauze dressing will be placed sterile in the operating room and will be changed daily
16042038|NCT02581891|Drug|Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)|3 monthly doses followed by individualized treatment intervals of between 8 to16 weeks based on protocol-defined anatomical criteria
16042039|NCT02581891|Drug|Eylea (Intravitreal Aflibercept, VEGF Trap-Eye, BAY86-5321)|3 monthly doses followed by five 8-weekly doses (5 x 2Q8), then by individualized treatment intervals of between 8 to 16 weeks based on protocol-defined anatomical criteria
16042040|NCT02581878|Drug|BAY1862864|Radiopharmaceutical, injection: Up to four treatment cycles lasting six weeks each; in each cycle, a single treatment on Day 1. In this dose-escalation part of the study, the radioactivity dose will start at 1.5 MBq and increase in steps of 1.5 MBq, with a antibody-chelator conjugate dose of 2 or 10 mg.
16042041|NCT02581865|Drug|NBI-98854|
16042042|NCT02581865|Drug|Placebo|
16042043|NCT02581852|Other|Cross sectional assessment|Assessment of workability, functional disability, frailty, muscle strength, quality of sleep and sexual functioning
16042044|NCT02581839|Drug|Eribulin Mesylate|Most subjects will begin eribulin mesylate at 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
16042045|NCT02581839|Device|MRI|An MRI will be completed at week 1, week 12 and every 12 weeks after cycles 4+ while on study eribulin mesylate
16042046|NCT02581839|Drug|Pre-Medication: Zofran|Zofran at 8mg orally. Given at the discretion of the treating physician
16042047|NCT02581839|Drug|Pre-Medication: Decadron|decadron at 8mg orally. Given at the discretion of the treating physician
16042048|NCT02581826|Drug|Silodosin|α1-adrenoceptor antagonists are distributed not only in the bladder neck, urethra, and prostate, but also in the seminal vesicle and vas deferens. Specifically, the distribution of messenger ribonucleic acid (mRNA) of α1-adrenoceptor antagonists in seminal vesicle and vas deferens is reported to be 75-97%. It is reasonable to use α1-adrenoceptor antagonists with high selectivity for patients with Premature Ejaculation (PE). A new highly selective α1-adrenoceptor antagonists, is strongly associated with dry ejaculation with loss of seminal emission. It had the highest selectivity for the vas deferens compared with other α1-adrenoceptor antagonists.The effectiveness of highly selective α1-adrenoceptor antagonists as a potential therapy for this class of patients was scarcely investigated.
16042049|NCT02581826|Drug|Placebo|No column specified.
16042050|NCT02581813|Behavioral|I.D.E.A.L. for Adolescents Study - Higher Dairy|12 weeks diet and exercise intervention characterized by higher dairy consumption (4 servings per day) and exercise 3 times per week
16042051|NCT02581813|Behavioral|I.D.E.A.L. for Adolescents Study - Lower Dairy|12 weeks diet and exercise intervention characterized by lower dairy consumption (0-1 serving per day) and exercise 3 times per week
16042052|NCT02581800|Other|App group|
16042053|NCT02581787|Biological|Fresolimumab|Given IV
16042054|NCT02581787|Other|Pharmacological Study|Correlative studies
16042055|NCT02581787|Radiation|Stereotactic Body Radiation Therapy|Undergo SABR
16042056|NCT02581774|Other|normal delivery tracking|normal delivery tracking
16042057|NCT02581761|Drug|CYTOTEC|synthetic prostaglandin E1
16042058|NCT02581761|Other|Placebo|no active material
16042059|NCT02581748|Drug|HLX02|
16042060|NCT02581748|Drug|Herceptin|
16042218|NCT02580500|Procedure|epidural catheter|epidural anaesthesia application for spinal catheter will be used
16042219|NCT02580500|Procedure|spinal catheter|spinal anesthesia application for spinal catheter will be used
16042061|NCT02581735|Other|Patients with haemophilia|"Using the platform Upatient, patients with hemophilia will register for one year, the prophylactic treatment who receive at home. Likewise, they indicate a replacement therapy as a result of joint bleeds.
~At baseline, a month, 6 months and at the end of the study, patients shall complete two questionnaires. The same way in the initial evaluation and end of the study, the clinical joint status will be evaluated with HJHS scale ."
16042062|NCT02581722|Device|PrePex Device|The PrePex device is designed to enable conducting male circumcision procedure that is bloodless with no anesthesia and no sutures. For contraindicated subjects, a preparation procedure will take place.
16042063|NCT02581709|Behavioral|Countering cognitive impairment|The intervention will include education about cancer-related cognitive impairment, instruction on relaxation techniques, compensatory techniques, goal-setting and lifestyle advice. Each session will last between 90 and 120 minutes, once a week for six weeks. The intervention will be delivered in a group setting, in a non-clinical environment by the investigators.
16042064|NCT02581696|Drug|Lafutidine|Lafutidine 10mg, 1 tablet, bid
16042065|NCT02581696|Drug|Irsogladine maleate|Irsogladine maleate 2mg, 2 tablet, qd
16042066|NCT02581683|Drug|Magnesium Sulfate|Given via adductor canal block
16042067|NCT02581683|Drug|Ropivacaine|Given via adductor canal block
16042068|NCT02581683|Other|Sham|Sham adductor canal block
16042069|NCT02581670|Radiation|stereotactic radiation therapy (SRT)|Lung and liver stereotactic radiation therapy (SRT) in oligometastatic breast cancer patients unsuitable for surgery, using VMAT RapidArc approach
16042070|NCT02581657|Drug|PE0139 Injection|PE0139 Injection
16042071|NCT02581657|Drug|Placebo Injection|Placebo Injection
16042072|NCT02581631|Biological|Nivolumab|
16042073|NCT02581631|Drug|Brentuximab Vedotin|
16042074|NCT02581618|Other|remote ischemic preconditioning|Blood pressure cuff inflation up to 200mmHg in the non-dominant arm before guiding catheter engagement
16042075|NCT02581605|Device|Custom-made 'cutting block'|To improve the accuracy of this operation we propose the use of a custom-made 'cutting block' tailored for each individual patient.
16042076|NCT02581592|Drug|TD-4208|A single inhaled dose of TD 4208 (175 mcg)
16042077|NCT02581579|Dietary Supplement|Nyaditum resae ® 10e5 of heat-killed Mycobacterium manresensis|Nyaditum resae ® 10e5 of heat-killed Mycobacterium manresensis, 1 capsule per day during 14
16042078|NCT02581579|Other|Placebo|Placebo, 1 capsule per day during 14
16042079|NCT02581566|Drug|Intrathecal Dexmedetomidine|Addition of Intathecal Dexmedetomidine plus Intrathecal Bupivacaine
16042080|NCT02581566|Drug|Intraarticular Dexmedetomidine|Addition of Intraarticular Dexmedetomidine plus Intrathecal Bupivacaine
16042081|NCT02581566|Drug|Bupivacaine|Intrathecal Bupivacaine
16042082|NCT02581553|Drug|lesinurad/allopurinol 200/300 FDC tablets|
16042083|NCT02581553|Drug|lesinurad 200 mg|
16042084|NCT02581553|Drug|allopurinol 300 mg|
16042085|NCT02581553|Drug|lesinurad/allopurinol 200/200 FDC tablets|
16042086|NCT02581553|Drug|allopurinol 200 mg|
16042087|NCT02581527|Drug|Rifampicin|Rifampicin 150mg (Control arm); Rifampicin 1200mg (Regimen 1); Rifampicin 1800mg (Regimen 2)
16042088|NCT02581527|Drug|Isoniazid|Isoniazid 75mg - all arms
16042089|NCT02581527|Drug|Ethambutol|Ethambutol 275mg - all arms
16042090|NCT02581527|Drug|Pyrazinamide|Pyrazinamide 400mg - all arms
16042091|NCT02581514|Other|Scheduled exams and diagnosis|Scheduled exams and diagnosis circuit as imposed by the algorithm
16042092|NCT02581501|Drug|GAX - Gemcitabine, Abraxane and Xeloda|GAX represents a novel approach to the development of cancer chemotherapy agents in pancreatic cancer and is based upon extensive laboratory investigations for the induction of apoptosis in pancreatic carcinoma cells. It is our expectation that this combination will induce apoptotic pathways downstream of biochemical mechanisms of resistance and synergistically induce pathways for apoptosis that are non-p53 dependent, which have not been previously explored in chemotherapy trials for this cancer.
16042093|NCT02581488|Biological|Santyl|
16042094|NCT02581488|Other|Product containing silver|Silver product not specified by the protocol; Investigators choose the appropriate silver containing product for each diabetic foot ulcer
16042095|NCT02581475|Procedure|Extending withdrawal time in the proximal colon|
16042096|NCT02581475|Procedure|Segmental examination twice of the proximal colon|
16042097|NCT02581462|Drug|FLOT alone|"Pre-operative therapy:
~Docetaxel 50 mg/m², d1, d15, d29, d43
~Oxaliplatin 85 mg/m², d1, d15, d29, d43
~Leucovorin 200 mg/m², d1, d15, d29, d43 (can be replaced by sodium folinate according to local guidelines)
~5-FU 2600 mg/m², d1, d15, d29, d43
~Surgery is recommended to be scheduled 4 weeks after d43.
~Post-operative therapy (start 6 to 8 weeks after surgery):
~Docetaxel 50 mg/m², d1, d15, d29, d43
~Oxaliplatin 85 mg/m², d1, d15, d29, d43
~Leucovorin 200 mg/m², d1, d15, d29, d43 (can be replaced by sodium folinate according to local guidelines)
~5-FU 2600 mg/m², d1, d15, d29, d43"
16042098|NCT02581462|Biological|FLOT + Herceptin/Pertuzumab|"Pre-operative therapy:
~Herceptin 8/6 mg/kg, d1, d22, d43
~Pertuzumab 840 mg, d1, d22, d43
~Docetaxel 50 mg/m², d1, d15, d29, d43
~Oxaliplatin 85 mg/m², d1, d15, d29, d43
~Leucovorin 200 mg/m², d1, d15, d29, d43 (can be replaced by sodium folinate according to local guidelines)
~5-FU 2600 mg/m², d1, d15, d29, d43
~Surgery is recommended to be scheduled 4 weeks after d43.
~Post-operative therapy (start 6 to 8 weeks after surgery):
~Herceptin 8/6 mg/kg, d1, d22, d43
~Pertuzumab 840 mg, d1, d22, d43
~Docetaxel 50 mg/m², d1, d15, d29, d43
~Oxaliplatin 85 mg/m², d1, d15, d29, d43
~Leucovorin 200 mg/m², d1, d15, d29, d43 (can be replaced by sodium folinate according to local guidelines)
~5-FU 2600 mg/m², d1, d15, d29, d43."
16042099|NCT02581449|Dietary Supplement|omega-3|dietary supplement
16042100|NCT02581449|Other|empty soft gelatin capsules|empty softgels of matched size, shape and color
16042101|NCT02581436|Other|kSORT assay based follow-up|kSORT assay in pre-established days: 14, 45, 90, 180, 365 and 540 of post transplantation follow-up. If kSORT result is positive maintenance immunosuppressive will be increased (tacrolimus trough levels 12-15 ng/mL, Mofetil Mycophenolate 1.5 mg every 24 hours and prednisone 5 mg/day) and graft biopsy will be obtained. Kidney biopsy will be obtained one mo after treatment as well as kSORT assay. If kSORT result is negative, the maintenance immunosuppressor dosages will remain as established in our institutional guidelines. If after a year of follow-up, the kSORT result is negative, immunosuppression will be decreased (Tacrolimus levels 5 - 10 ng/ml and mofetil mycophenolate 500 mg every 12 hours).
16042102|NCT02581436|Other|Standard follow-up|Surveillance will be the usual, includes creatinine determinations and clinical evaluation as often as established in the institutional protocol. A kidney graft biopsy will be obtained in case of dysfunction (increase in serum creatinine >25% above baseline or 0.3 mg/mL above baseline) or as part of our institutional programmed biopsies (months 3 and 12). Treatment will be established in accordance with biopsy results. In all cases of rejection a kidney biopsy will be obtained one month after initiating treatment. In this control group, samples for kSORT analysis will be collected on pre-established dates for the study, but patient treatment will not be contingent on the assay's results; investigators will be blinded to the result in this control patient group.
16042103|NCT02581423|Drug|Capecitabine|Participants will receive oral capecitabine, 1250 miligrams per meter-squared (mg/m^2) twice daily, in 3-week treatment cycles for up to 8 cycles. Treatment will be administered for 2 weeks followed by 1 week of rest without medication.
16042104|NCT02581410|Biological|GSK Biologicals Herpes Zoster subunit (HZ/su) vaccine (GSK 1437173A)|2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm.
16042105|NCT02581397|Drug|Transpulmin suppository|01 suppository in the morning and 01 at night, via rectal, for 03 or 07 days
16042106|NCT02581397|Drug|Guaiacol suppository|01 suppository in the morning and 01 at night, via rectal, for 03 or 07 days
16042107|NCT02581397|Drug|Transpulmin syrup|7,5ml every 4 hours, orally, for 03 or 07 days
16042108|NCT02581384|Radiation|Stereotactic Body Radiotherapy (SBRT)|
16042109|NCT02581371|Drug|Cerebrolysin infusion|Two 10-day courses of 50 ml of investigational drug + 50 ml of sodium chloride 0.9% iv slowly drip infusions daily, separated with a 7-day interval
16042110|NCT02581371|Other|Placebo infusion|Two 10-day courses of 100 ml of sodium chloride 0.9% iv slowly drip daily, separated with a 7-day interval
16042111|NCT02581358|Other|Scolioscan (Ultrasound imaging system)|To assess the scoliotic patient, a 3D ultrasound imaging system (the Scolioscan) was developed. The system composes of an ultrasound scanner with a linear probe, a frame structure, an electromagnetic spatial sensing device and a dedicated PC program for imaging and data collection, processing, visualization, analysis, and assessment. The spatial sensor was attached to the ultrasound probe for spatial information collection and calibration. The Scolioscan will generate ultrasound images of the spine for quantitative assessment of the curve deformity in terms of Cobb angles.
16042112|NCT02581345|Biological|M923|Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)
16042113|NCT02581345|Biological|Humira|Recombinant human immunoglobulin G subclass 1 (IgG1) monoclonal antibody specific for human tumor necrosis factor-alpha (TNF-α)
16042114|NCT02581332|Behavioral|Mindfulness Meditation Training|Training will be held in groups of up to five participants. All of the participants within this group will receive up to 6 days (20m/d) of meditation training to be administered over 15 days. This is a paradigm similar to one employed in previous studies.
16042115|NCT02581319|Procedure|Periodontal treatment|Periodontal treatment will consist of scaling and planning root, 4 times in the first month and after that once a month until complete one year. Patients will be clinically evaluated and microbiological collects were made at baseline, 3 months, 6 months and 1 year after periodontal treatment.
16042116|NCT02581306|Other|Exercise session|There is no drug or device intervention in this study. Subjects will exercise at a moderate intensity for 60 minutes and a blood sample will be obtained before and after the exercise session
16042117|NCT02581293|Procedure|Group 1: Only visceral peritoneum will be closed|
16042118|NCT02581293|Procedure|Group 2 : Only parietal peritoneum will be closed|
16042119|NCT02581293|Procedure|Group 3 : Both of them will be closed|
16042120|NCT02581293|Procedure|Group 4: None of them will be closed|
16042121|NCT02581280|Other|Residual blood|Residual blood samples(1~2 cc) at each sampling time are collected from all subjects while using ECMO for drug concentration assays(LC-MS/MS etc.).
16042122|NCT02581254|Device|Thin Wire Snare|
16042123|NCT02581254|Device|Thick Wire Snare|
16042124|NCT02581241|Device|tilt table|"Participating individuals will be instructed to rest supine for 10 minutes while repeat electrocardiograms are recorded. They will then be instructed to stand up quickly and remain standing still for 10 minutes.
~Individuals with inability to stand up quickly will be tested with tilt table test used in our hospital"
16042125|NCT02581228|Device|ML-PrediCare|
16042126|NCT02581215|Drug|mFOLFIRINOX|"mFOLFIRINOX:
~Oxaliplatin 85 mg/m2 over 2-4 hours
~Irinotecan 165 mg/m2 over 90 minutes
~5-FU 2,400 mg/m2 as a 46-hour continuous infusion without the 5-FU bolus to decrease the risk of neutropenia."
16042127|NCT02581215|Drug|Ramucirumab|Ramucirumab administered as an intravenous infusion over 60 minutes (infusion rate should not exceed 25 mg/min), at a fixed dose of 8 mg/kg every 2 weeks.
16042128|NCT02581215|Other|Placebo|Placebo infusion with volume calculated as if it were ramucirumab every 2 weeks.
16042129|NCT02581202|Drug|lopinavir/ritonavir|tablet
16042130|NCT02581202|Drug|lamivudine|tablet
16042131|NCT02581189|Drug|Ombitasvir/paritaprevir/ritonavir|Co-formulated tablet
16042132|NCT02581189|Drug|Dasabuvir|Tablet
16042133|NCT02581189|Drug|Ribavirin|Tablet
16042134|NCT02581176|Drug|Apixaban|
16042135|NCT02581163|Drug|Ombitasvir/paritaprevir/ritonavir|Co-formulated tablet
16042136|NCT02581163|Drug|Dasabuvir|Tablet
16042137|NCT02581163|Drug|Ribavirin|Tablet
16042138|NCT02581150|Procedure|Treatment of Occlusive Arterial Disease|Regarding the intervention, the technique used during the diagnostic and/or therapeutic procedure shall be left to the operator's discretion, except the use of an arterial closure device (ACD). In the ambulatory hospitalisation arm, the ACD use will be mandatory. In the conventional hospitalisation arm, ACD will be used at the discretion of the interventionalist.
16042139|NCT02581137|Other|Laboratory Biomarker Analysis|Correlative studies
16042140|NCT02581137|Drug|Metformin Hydrochloride|Given PO
16042141|NCT02581124|Drug|JTZ-951|
16042142|NCT02581124|Drug|Lapatinib|
16042143|NCT02581111|Drug|Naloxone|Naloxone 8-mg IV bolus
16042144|NCT02581111|Drug|Normal saline|
16042145|NCT02581098|Other|No interventions|No interventions
16042220|NCT02580487|Procedure|appendicectomy|Appendix was removed either laparoscopically or open surgery
16042221|NCT02580474|Drug|Daclatasvir plus Asunaprevir|
16042146|NCT02581085|Drug|Tocotrienol (TCT)|TCT is a natural vitamin E supplement with a long history of safe dietary consumption in humans. The objective of the current trial is to validate the outcome observed in an earlier trial that oral TCT attenuates the rise in MELD score over time in patients with end stage liver disease/cirrhosis.
16042147|NCT02581085|Other|Placebo|Control study capsule that includes no study product (Vitamin E - Tocotrienol)
16042148|NCT02581072|Drug|SB204 4%|Applied topically once
16042149|NCT02581072|Drug|SB204 8% or 12%|Applied once topically
16042150|NCT02581072|Drug|Vehicle|Applied topically once
16042151|NCT02581059|Drug|Regorafenib|All subjects will receive regorafenib 160 mg orally once daily for the first 21 days of each 28-day cycle for 2 cycles.
16042152|NCT02581059|Dietary Supplement|Ginseng|Subjects randomized to ginseng will receive 1,000 mg orally twice every day of each 28-day cycle for 2 cycles.
16042153|NCT02581046|Procedure|Phacomulsification lens removal cataract surgery without Intraocular lens(IOL) implantation at the age of 3month of the patients|The surgical timing of phacoemulsification is perform at the age of 3 month of the patients. During Phacoemulsification, viscoelastic materials and anterior lens capsule are used to protect corneal endothelial cells.
16042154|NCT02581046|Procedure|Phacomulsification lens removal cataract surgery without Intraocular lens(IOL) implantation at the age of 6 month of the patients|The surgical timing of phacoemulsification is perform at the age of 6 month of the patients. During Phacoemulsification, viscoelastic materials and anterior lens capsule are used to protect corneal endothelial cells.
16042155|NCT02581046|Drug|Subconjunctival dexamethasone and general anesthesia|All patients received subconjunctival dexamethasone (2 mg) during surgery, and all surgeries were performed under general anesthesia.
16042156|NCT02581033|Drug|Nucleoside Analogue therapy|Determinants of sustained virological response after discontinuation of long-term nucleoside analogue therapy in chronic hepatitis B patients.
16042157|NCT02581007|Drug|Fludarabine|fludarabine (30mg/m2) given every day starting on Day -6 through Day -2;
16042158|NCT02581007|Drug|Melphalan|
16042159|NCT02581007|Drug|Cyclophosphamide|cyclophosphamide (50mg/kg) given every day starting on Day 3 through Day 4.
16042160|NCT02581007|Procedure|peripheral blood stem cell transplant|
16042161|NCT02580994|Drug|Pembrolizumab|IV infusion at the dose of 200 mg on day 1 every 3 weeks
16042162|NCT02580994|Drug|cis/carboplatin and etoposide|Cisplatin 80 mg/m2 or Carboplatin Area Under the Curve (AUC) 5 IV infusion on day 1 Etoposide 100 mg/m2 IV infusion on day 1, 2 and 3
16042163|NCT02580981|Other|Acute Lymphobastic Leukemia (ALL) Treatment Options|Depending on the genomic testing results, patients with targetable genomic lesions will be enrolled onto available national clinical trials that are sponsored by the NCI National Clinical Trials Network (NCTN) (COG and other adult NCI Cooperative Groups). If no suitable NCTN trial exists, appropriate therapeutic regimens (including currently accepted standards-of-care), alterations in therapy, or treatment with targeted agents to specific genomic lesions will be considered.
16042164|NCT02580968|Device|electro-acupuncture|electro-acupuncture on acupoints according to the traditional syndrome diagnosis.once per day, for 20 days.
16042165|NCT02580968|Drug|flunarizine hydrochloride|flunarizine hydrochloride ，10mg/day，for 20 days。
16042166|NCT02580955|Device|LEGFLOW DCB|
16042167|NCT02580942|Device|Magnetic stickers|36 patients receive acupoint sticking treatment of Chinese herbal medicine on Dazhui(GV14) and Tiantu(RN22), and magnetic stickers on Feishu(BL13), Pishu(BL20) and Shenshu(BL23) once every other day, retention for 4 hours. Patients receive verum acupoint sticking therapy once every other day with a total of 18 sessions in 6 weeks.
16042168|NCT02580942|Device|Sham magnetic stickers|36 patients receive acupoint sticking treatment of Chinese herbal medicine on Dazhui(GV14) and Tiantu(RN22), and sham magnetic stickers on Feishu(BL13), Pishu(BL20) and Shenshu(BL23) once every other day, retention for 4 hours. Patients receive verum acupoint sticking therapy once every other day with a total of 18 sessions in 6 weeks.
16042169|NCT02580942|Drug|Chinese herbal medicine|72 patients receive acupoint sticking treatment of Chinese herbal medicine on Dazhui(GV14) and Tiantu(RN22).
16042170|NCT02580929|Radiation|radiotherapy|radiotherapy before surgery
16042171|NCT02580916|Other|SCQOLIT questionnaire|"Participants will be invited to complete the SCQOLIT and EQ-5D (used for comparison purposes, given its widespread use in other healthcare contexts in the UK) questionnaires [Appendices C & D) at:
~baseline (after histological diagnosis of a NMSC is confirmed - both Groups)
~3 months - either by postal (Group 1) or face-to-face (Group 2) dependent on whether the patient is returning to the Dermatology clinic for routine follow-up
~at 6-9 months in the dermatology clinic if the patient is deemed high risk (squamous cell carcinoma with high risk clinicopathological features as listed by the National British Association Dermatologists Multiprofessional Guidelines for management of SCC) (Group 2 only)"
16042172|NCT02580903|Radiation|Radiology|Only a small subsample will require CT and right heart catherisation
16042173|NCT02580890|Device|tDCS active|Stimulation will be performed with the anode placed over the right DLPFC, and the cathode placed on the left DLPFC. The applied electric current will be 2mA and is going to be applied for 20 minutes. The electrodes have a size of 35cm ² each and will be covered by sponges soaked with saline.
16042174|NCT02580890|Device|tDCS sham|For the sham tDCS, the same setting will be used. However, the current is going to be applied for only 30 seconds, not being able to induce effects on neuronal excitability.
16042175|NCT02580877|Drug|67.5 mg oral insulin crystals daily|human insulin crystals in capsules
16042176|NCT02580877|Drug|500mg oral insulin crystals every other week|human insulin crystals in capsules
16042177|NCT02580851|Other|diagnostic test - cardiac magnetic resonance imaging|
16042178|NCT02580851|Other|diagnostic test - coronary angiography|
16042179|NCT02580838|Drug|OnabotulinumtoxinA|Early OnabotulinumtoxinA group will receive OnabotulinumtoxinA injection when their spasticity develop, late OnabotulinumtoxinA group will have injection at 6 months after emergence of spasticity, the third group will not have OnabotulinumtoxinA intervention.
16042253|NCT02580162|Behavioral|FBT for Pediatric Weight Management by Peers|This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change. This 20 week treatment is adapted from our existing evidence-based interventions and is provided by PEER interventionists.
16044158|NCT02566967|Drug|tofacitinib|oral tofacitinib will be taken 2 times daily
16042180|NCT02580825|Behavioral|Biofeedback gait retraining|Each session will include a continuous exercise in which the patient will do walking, walking pace and running (3 minutes each section). During the meeting, participant will receive biofeedback that will displayed on a computer screen that shows the forces that develop in the knee joint so that the patient can see graphically the forces that develop around the knee joint and will be guided / try to reduce the values of the graph by changing the intensity of his landing on the tracks. In all training the time that the biofeedback is shown will be reduced.
16042181|NCT02580825|Behavioral|Exercise|Each session will include a continuous exercise in which the patient will do walking, walking pace and running (3 minutes each section).
16042182|NCT02580812|Other|Clinical and neuropsychological evaluation procedure|WPPSI, NEPSY, Brief, SDQ, Vineland and SCQ evaluation Clinical examination
16042183|NCT02580786|Behavioral|Breastfeeding peer support|
16042184|NCT02580773|Drug|Prophylactic anticoagulation ( INNOHEP®)|subcutaneous anticoagulation with low molecular weight heparin (tinzaparin) at a prophylactic dose (4500 UI/day)
16042185|NCT02580773|Drug|Curative anticoagulation ( INNOHEP®)|subcutaneous anticoagulation with low molecular weight heparin (tinzaparin) at a curative dose (175 UI/kg/day for 7 days)
16042186|NCT02580747|Biological|anti-meso-CAR vector transduced T cells|genetically engineered lymphocyte therapy
16042187|NCT02580734|Dietary Supplement|melatonin|Cross-over randomized clinical trials
16042188|NCT02580721|Device|Dentsply Astra Tech Implant System EV|Dentsply Astra Tech Implant System EV will be placed
16042189|NCT02580708|Drug|Rociletinib|
16042190|NCT02580708|Drug|Trametinib|
16042191|NCT02580695|Biological|umbilical-cord mesenchymal stromal cells|Intra-articular knee injection of UC-MSC 20x10e6 at 0 and 6 months
16042192|NCT02580695|Drug|Hyaluronic Acid|Intra-articular knee injection of Hyaluronic Acid (3ml) at 0 and 6 months
16042193|NCT02580682|Drug|Sanfu herbal patch|The formula of the patch consists of Huang Qi (Astagalus Membranaceus), Fu Zi (Aconiti Lateralis Radix Praeparata), Yan Hu Suo (Rhizoma Corydalis), Xi Xin (Herba As5ari), Bai Jie Zi (Semen Sinapis Albae) and Rou Gui(Cortex Cinnamomi), in a proportion of 2:2:1:1:2:1.
16042194|NCT02580682|Drug|Sanfu moxibustion|Moxibustion is a kind of thermal therapy without any feeling of pain or swell.Moxibustion exerts its therapeutic effect by thermal power and the application of moxa.
16042195|NCT02580682|Drug|Sanfu herbal patch and moxibustion|use Sanfu moxibustion followed by Sanfu herbal patch
16042196|NCT02580669|Other|Neuropsychological assessment|A neuropsychological assessment is done
16042197|NCT02580669|Other|Neurologic consultation|A neurologic consultation is done
16042198|NCT02580669|Other|MRIs (with vasoreactivity testing)|MRIs (with vasoreactivity testing) is done
16042199|NCT02580656|Behavioral|Metacognitive Therapy|MCT helps patients to understand the deleterious and counterproductive effects of responding to negative thoughts and feelings with worry and rumination. Treatment aims to enable patients to exert greater metacognitive control over their worry and rumination. The positive and negative metacognitive beliefs that keep perseverative thinking in place are modified, using verbal and behavioural reattribution and through specifically designed therapeutic methods.
16042200|NCT02580643|Biological|APS|intra-articular injection
16042201|NCT02580630|Behavioral|Reduction in running and jumping|Advocate to avoid running and jumping sports for the first 3 months, thereafter slowly progressing to normal sport activity.
16042202|NCT02580630|Other|Training|Patients are instructed to carry out strengthening exercises for the diseased achilles tendon 3 times a week. Physiotherapist will instruct all patients in these heavy slow resistance exercises. First time one week after the first injection, and then week 3, 6, 10. The patient will register all training on a diary and on an App.
16042203|NCT02580630|Drug|Ultrasound guided injection with Glucocorticosteroid|Ultrasound guided injection in Kagers triangle underneath the thickest part of the achilles tendon with 1ml Lidocain 5 mg/ml and 1 ml methylprednisolone 40mg/ml. Injection is given every months until the tendon pain is markedly reduced (VAS morning pain: 0-20, and VAS training pain: 0-40, and Global recovery rating scale (-5 to +5) is +3 to +5 ). (max 3 injections).
16042204|NCT02580630|Drug|Ultrasound guided injection with local anaestethic|Ultrasound guided injection in Kagers triangle underneath the thickest part of the achilles tendon with 1ml Lidocain 5 mg/ml and 1 ml of intralipid (for blinding). Injection is given every months until the tendon pain is markedly reduced (VAS morning pain: 0-20, and VAS training pain: 0-40, and Global recovery rating scale (-5 to +5) is +3 to +5 ). (max 3 injections).
16042205|NCT02580617|Biological|ALLO-ASC|Infusion for Crohn's disease
16042206|NCT02580604|Drug|Calcium Chloride/Calcium Gluconate|Calcium (as either calcium chloride or calcium gluconate in half normal saline) will be delivered via IV during exercise to keep serum ionized calcium levels above baseline. The clamp is modeled after the hyperglycemic glucose clamp.
16042207|NCT02580604|Drug|Placebo|Saline Infusion
16042208|NCT02580591|Drug|Empagliflozin|
16042209|NCT02580591|Drug|Placebo|For blinding purposes
16042210|NCT02580578|Other|No Intervention|No intervention is administered in this study.
16042211|NCT02580565|Other|telephone interview|Clinical assessment for screening and a phone call for questionnaire administration
16042212|NCT02580552|Drug|Cobomarsen|
16042213|NCT02580539|Biological|Group A|Peptide-stimulated T cells 2 x 10^7/m^2
16042214|NCT02580539|Biological|Group B|Peptide-stimulated T cells per dose-escalation protocol
16042215|NCT02580526|Procedure|V-E mask ventilation for one minute|"V-E approach maintains mouth open, creates larger oral cavity and allow positive pressure generated during inspiration to push forwards submandibular region.
~When apnea occurs after anesthesia induction subjects will be ventilated with one of the two techniques randomly, either two-handed C-E facemask ventilation technique or with V-E technique. Ventilation will be carried out using pressure mode ventilation at respiratory rate of 10 breaths per minute. Subject will start with one technique and then cross over to the other technique."
16042216|NCT02580526|Procedure|C-E mask ventilation for one minute|"Using C-E technique, the operator's fingers pressure mouth closed and push posteriorily the soft tissue of submandibular region.
~When apnea occurs after anesthesia induction subjects will be ventilated with one of the two techniques randomly, either two-handed C-E facemask ventilation technique or with V-E technique . Ventilation will be carried out using pressure mode ventilation at respiratory rate of 10 breaths per minute. Subject will start with one technique and then cross over to the other technique."
16042222|NCT02580461|Behavioral|A 24 week center-based structured exercise and education program|The intervention will consist of a strength and aerobic exercise program. The exercise program will include twice weekly group resistance exercises classes, twice monthly group education classes, and individual activities to achieve 150 weekly minutes of aerobic activity. The resistance exercise and education classes will be run at a gym space at the University of Calgary. The wait-list control participants will be told not to change their activity levels throughout the 12 weeks of the trial. The wait list control participants will be enrolled into the exercise and education intervention once they have completed 12 weeks of wait-list control. A 12 week maintenance exercise program will be offered to all participants who finish the 12 week exercise and education program. The maintenance exercise program will consist of once weekly resistance group based exercise classes and individual activities to achieve 150 weekly minutes of aerobic physical activity.
16042223|NCT02580448|Drug|Seviteronel|Seviteronel given daily with evening meal in 28 day cycles
16042224|NCT02580409|Behavioral|Exercise Intervention|Investigators are proposing an innovative rehabilitative care program for older primary care patients at risk for mobility decline. The program targets newly identified risk factors for mobility decline and utilizes mobile health technology to deliver patient centered care more efficiently. Study participants will receive exercise instruction with a licensed physical therapist for an average of 8-10 training sessions, with the possibility of up to 16 sessions. some at home and some in the clinic. The exercise training sessions will focus on improving mobility, balance and ability to get up from a chair with the use of an exercise application (Wellpepper) being used on a study issued iPad.
16042225|NCT02580396|Device|CanADVICE+® (smart phone app)|The main objective of this project is to optimise pharmaceutical counselling services by providing drug related information, in a digital format, to patients with metastatic breast cancer receiving Capecitabine.
16042226|NCT02580383|Procedure|Radiofrequency neurotomy of lumbar medial branch|In above L5, The RF needle was placed to contact with bone as close as possible to the course of the target nerve in parallel. For L5 dorsal rami ablation, the needle was positioned in the groove between the S1 articular process and sacral ala. At each level, the electrodes were adjusted to optimize sensory stimulation at a frequency of 50 Hz and maximize multifidus contraction at 2 Hz. A 75 second 80°C lesion was made using an RF generator.
16042227|NCT02580370|Biological|Botulinum toxin type A|Topical botulinum toxin type A
16042228|NCT02580370|Biological|Placebo comparator|Topical placebo comparator
16042229|NCT02580357|Procedure|Low Level Laser Therapy|Low Level Laser Therapy on the palatal donor site of connective tissue graft.
16042230|NCT02580357|Device|GaAlAs laser|Utilization of GaAlAs laser to irradiation on the palatal donor site.
16042231|NCT02580344|Drug|Ibuprofen|The women will receive 400mg ibuprofen 3 times per day from the first day of the cycle for 5 days
16042232|NCT02580331|Drug|SRP and placebo|Placement of placebo gel into classII furcation defects after scaling and root planing
16042233|NCT02580331|Drug|SRP and 1% metformin|Placement of 1% metformin gel into classII furcation defects after scaling and root planing
16042234|NCT02580318|Device|breathalyzer|
16042235|NCT02580305|Drug|SUVN-502|Once-daily, tablets, orally
16042236|NCT02580305|Drug|Placebo|Once-daily, tablets, orally
16042237|NCT02580305|Drug|Donepezil|Donepezil HCl (10 mg, once a day)
16042238|NCT02580305|Drug|Memantine|Memantine HCl (10 mg, twice a day or 28 mg extended-release, once a day).
16042239|NCT02580279|Drug|EGCG|
16042240|NCT02580279|Drug|placebo|
16042241|NCT02580253|Drug|Individualized Chemotherapy|Two drug combination adjuvant chemotherapy based on the Adenosine Triphosphate Tumor Chemosensitivity(Oxaliplatin, Gemcitabine, Irinotecan, Paclitaxel,docetaxel, Fluorouracil,Doxorubicin,Cisplatin)
16042242|NCT02580253|Drug|mFOLFOX6|Oxaliplatin,Fluorouracil
16042243|NCT02580240|Drug|Hydrocortisone|Hydrocortisone was administered 200 mg/d as a continuous infusion for 6d, then tapered off. Once all vasopressors were discontinued, the taper protocol was initiated (half dose for three days, then quarter dose for three days and then stopped).
16042244|NCT02580240|Drug|saline|Vials containing normal saline as placebo were identical to those containing hydrocortisone. Placebo administration procedures were similar.
16042245|NCT02580227|Drug|Tranexamic Acid|All subjects will be given 1g of TXA in 100cc normal saline, or placebo of 100cc normal saline at time of admission, after consent is given.
16042246|NCT02580227|Other|Placebo|All subjects will be given 1g of TXA in 100cc normal saline, or placebo of 100cc normal saline at time of admission, after consent is given.
16042247|NCT02580214|Dietary Supplement|Impact|600 ml of Impact, Nestle for 5 days prior to surgery
16042248|NCT02580201|Biological|Oral Polio Vaccine|"Opvero™ (oral) is a trivalent, live attenuated poliomyelitis virus vaccine containing at least 6.0 log 50% cell culture infective dose (CCID50) of LS c2ab strain of live attenuated polio virus type 1, 5.0 log CCID50 of P712, Ch, 2ab strain of live attenuated polio virus type 2, 5.8 log CCID50 Leon I2aIb strain of polio virus type 3. Excipients: human albumin, HEPES buffer solution, magnesium chloride solution (containing polysorbate 80 and phenol red), hydrochloric acid or sodium hydroxide for pH adjustment.
~The vaccine is presented as a suspension for oral administration. One dose of vaccine (0.1 ml) is contained in two drops which are delivered from the dropper supplied with the multidose container."
16042249|NCT02580188|Drug|sugammadex|Maintenance dose of 0.4-0.9 mg/kg/hr rocuronium as continuous infusion during surgery for the maintenance of post tetanic count 1-2 (deep block).
16042250|NCT02580175|Procedure|Blinded evacuation|Ring evacuation was performed in the conventional way without use of ultrasound followed by sharp gentle curettage until complete evacuation.
16042251|NCT02580175|Procedure|Evacuation under ultrasound guidance|Ring evacuation was performed under ultrasound guidance followed by sharp gentle curettage until complete evacuation. The surgery was considered complete when the endometrial cavity appeared as a regular echogenic line.
16042252|NCT02580162|Behavioral|FBT for Pediatric Weight Management by Professionals|This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change. This 20 week treatment is adapted from our existing evidence-based interventions and is delivered by PROFESSIONAL interventionists.
16042254|NCT02580162|Behavioral|Peer Interventionists|Parents who receive FBT complete 6 weeks of training and then serve as peer interventionists to a new group of families.
16042255|NCT02580149|Drug|Ticagrelor|"Subjects will receive an oral loading dose of 180 mg ticagrelor on study day
~1 followed by a maintenance dose of 90 mg twice daily for 14 days (until study day 15)."
16042256|NCT02580149|Drug|Clopidogrel|Subjects will receive a loading dose of 600 mg clopidogrel on the first study day followed by a maintenance dose of 75 mg once daily for 14 days
16042257|NCT02580123|Behavioral|Intervention taught by trained educators|
16042258|NCT02580110|Other|Sucrose|
16042259|NCT02580110|Other|Stevia glycosides|
16042260|NCT02580110|Other|saccharin|
16042261|NCT02580097|Other|MRI|MRI perfusion imaging, including contrast bolus perfusion imaging and arterial spin labeling.
16042262|NCT02580084|Procedure|Hybrid Intervention|"The puncture of the femoral artery general is executed and the introducer 7Fr is set. Further, the hydrophilic conductor executes a recanalization of the Vasa of iliac artery occlusion. if you cannot pass the occlusion retrograde is additional access to antegrade recanalization. Then using hydrophilic conductors, an iliac artery antegrade or retrograde recanalization of the Vasa is made.
~Femoral artery arteriotomy. Further execute a direct endarterectomy femoral artery and from the mouth of a hip artery.
~arteriotomy of the femoral artery is closed with a vascular patch use (synthetic or biological).
~Balloon angioplasty and stenting, iliac artery is done, the controlling angiography Closing maims."
16042263|NCT02580084|Procedure|Aorta femoral Bypass|It is sufficient to identify only the anterior-lateral aorta surface. After heparinization the aorta is clamped above and below the anastomosis. The aorta is dissected along the anterior wall, calcium portions or mural thrombus are removed. Prosthesis is cut obliquely and anastomosis suturing starts with distal angle. Occluded at the prosthetic base jaws, aortic compressor is removed, restoring blood flow in the lower limb. Next stage is tunnel creating for jaws prosthesis conduction on hip. Ureters must remain over the prosthesis, jaw should be above the iliac arteries. After jaws prosthesis conduction on hip distal anastomosis is formed with twisting controlling. Before anastomosis completion the testing jaws and all arteries bloodletting is performed.
16042264|NCT02580071|Dietary Supplement|Sheng-Yu-Tang|"Granulated formula will be prescribed by KO DA Pharmaceutical co., LTD (科達) composition of formula is as follows: Radix Rehmanniae Praeparata 4g Radix Paeoniae Alba 4g Radix Astragali 4g Radix Ginseng 4g Radix Angelice Sinensis 2g Rhizoma Chuanxiong 2g (for preperation method and concentration ratio's please refer to manufacturers information)
~patients will be required to take 4.2gr, t.i.d (total of 12.6gr per day)"
16042265|NCT02580058|Biological|avelumab|10 mg/kg will be given as a 1 hour intravenous infusion (IV) every 2 weeks (Q2W) in 4 week cycles
16042266|NCT02580058|Drug|PLD|PLD (Arm B, Arm C) 40 mg/m2 will be given as a 1 hour IV infusion every 4 weeks (Q4W) in 4 week cycles
16042267|NCT02580032|Other|No treatment given|No treatment given.
16042268|NCT02580019|Biological|Human umbilical cord mesenchymal stem cells|A single dose of 2×107 hUC-MSC will treated to patients, IV, Repeat every weeks for four times.
16042269|NCT02580006|Drug|EPORON|single dose administration subcutaneously
16042270|NCT02580006|Drug|EPREX|single dose administration subcutaneously
16042271|NCT02579993|Procedure|Pannus and conjunctival dissection|A complete conjunctival peritomy is performed and the fibrovascular pannus and conjunctiva invading the cornea is dissected from the cornea and limbus.
16042272|NCT02579993|Procedure|Human cultivated limbal stem cell transplantation|The amniotic membrane graft cultured with the human limbal stem cell transplantation is placed in the limbic and corneal surface and fixed with fibrin glue. The amniotic membrane is placed with the stroma in contact with the graft and it is sutured.
16042273|NCT02579980|Procedure|DCE and DWI MRI|Dynamic Contrast Enhanced MRI (DCE-MRI) and Diffusion Weighted MRI (DW-MRI): DW-MRI is a technique for quantifying the increase in water diffusion caused by cellular necrosis or apoptosis in tumors within days of therapy. DCE-MRI is frequently used in preclinical and early clinical trial assessment of anti-angiogenic and vascular disrupting compounds, also within hours of therapeutic intervention.
16042274|NCT02579980|Procedure|Surgery|Standard of care procedure for sarcoma patients
16042275|NCT02579967|Drug|Immunosuppression Only Conditioning -Closed with amendment L|Pentostatin 4 mg/m2/day IV on days -9 and -5, cyclophosphamide 5 mg/kg orally daily on days -9 through -2 (Closed with amendment L)
16042276|NCT02579967|Drug|Reduced Intensity Conditioning|pentostatin 4 mg/m2/day IV on days -11 and -7, cyclophosphamide 3 mg/kg orally daily on days -11 through -4; busulfan IV, pharmokinetically dosed, on days -3 and -2.
16042277|NCT02579967|Drug|Myeloablative Conditioning-Closed with amendment L|Pentostatin 4 mg/m2/day IV on days -13 and -9, low-dose cyclophosphamide orally daily on days -13 through -6; busulfan IV, pharmokinetically dosed, on days -5, -4, -3, and -2. (Closed with amendment L)
16042278|NCT02579967|Drug|GVHD Prophylaxis|High-dose, post-transplantation cyclophosphamide (PTCy) 25-50 mg/kg on days +3 and +4, sirolimus 6 mg on days +5 through +90, and mycophenolate mofetil (MMF) on days +5 through 0, +18, +25, or +35 depending on treatment arm and cohort.
16042279|NCT02579967|Procedure|Allo BMT|Allogeneic blood or marrow transplantation
16042280|NCT02579954|Behavioral|Rehabilitation|
16042281|NCT02579941|Procedure|Blood sampling (pregnant)|"5.4 ml of venous blood will be taken during the delivery or the caesarian procedure, in addition to the standard of care blood sampling.
~This blood vial will be sent to the coagulation laboratory and all tests will be performed in vitro. The blood sample will be split in several aliquots. In each blood sample, fibrinolysis will be activated by the plasminogen tissular activator (tPA - concentration: 1066 UtPA/ml). Tranexamic acid will be added at increasing concentrations (2.5 microg/ml up to 40 microg/ml) to each sample and coagulation will be measured by two different tests: EXTEM and NATEM."
16042282|NCT02579941|Procedure|Blood sampling (non pregnant)|"5.4 ml of venous blood will be taken.
~This blood vial will be sent to the coagulation laboratory and all tests will be performed in vitro. The blood sample will be split in several aliquots. In each blood sample, fibrinolysis will be activated by the plasminogen tissular activator (tPA - concentration: 1066 UtPA/ml). Tranexamic acid will be added at increasing concentrations (2.5 microg/ml up to 40 microg/ml) to each sample and coagulation will be measured by two different tests: EXTEM and NATEM."
16042283|NCT02579928|Drug|Ketamine|A single dose of 0.5mg/kg of Ketamine will be administered Intravenously during 40 minutes in the Hospital Research Unit of YNHH. The subject will be monitored continuously during the procedure, and every hour for three hours after the infusion.
16042363|NCT02579369|Other|Allogeneic mesenchymal stem cells|Dressing for Dystrophic Epidermolysis Bullosa wound.
16042284|NCT02579928|Drug|Midazolam|A single dose of 0.045mg/kg of Midazolam will be administered intravenously during 40 minutes in the Hospital Research Unit of YNHH. The subject will be monitored continuously during the procedure, and every hour for three hours after the infusion.
16042285|NCT02579915|Behavioral|FaceAnxiety|Computerized treatment targeting mental habits and primary care linkage.
16042286|NCT02579915|Behavioral|Symptom Tracking|Weekly self-assessment with validated questionnaires and primary care linkage
16042287|NCT02579902|Dietary Supplement|Vitamin D3 (Cholecalciferol)|50000 IU Vitamin D3 (Cholecalciferol) will be given as one gelcaps every 2 weeks for a period of 6 months.
16042288|NCT02579902|Dietary Supplement|placebo|placebo will be given in identical gelcaps once every 2 weeks for a period of 6 months.
16042289|NCT02579889|Device|DDD+CLS|Device will be programmed in a dual-chamber DDD pacing mode with the Closed Loop Stimulation (CLS) function ON
16042290|NCT02579889|Device|DDD(R)|Device will be programmed in a dual-chamber DDD(R) pacing mode with the Closed Loop Stimulation (CLS) function OFF
16042291|NCT02579876|Drug|Viaskin Milk 500 mcg|Biological: Viaskin Milk 500 mcg Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins.
16042292|NCT02579876|Drug|Viaskin Placebo|Biological: Viaskin Placebo Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.
16042293|NCT02579863|Biological|Pembrolizumab|IV infusion
16042294|NCT02579863|Drug|Lenalidomide|oral capsules
16042295|NCT02579863|Drug|Dexamethasone|oral tablets
16042303|NCT02579837|Device|Optos 200Tx|non-mydriatic ultra-widefield (UWF) retinal imaging device
16042304|NCT02579837|Device|Zeiss Cirrus|optical coherence tomographer (OCT)
16042305|NCT02579824|Drug|DS-3032b|Escalation DS-3032b starting dose level 90 mg/day administered once daily by mouth on Days 1 - 21 of a 28 day cycle. For Dose Expansion maximum tolerated dose from Dose Escalation Phase.
16042306|NCT02579811|Drug|Axitinib|The intent is to maximize sustained dose intensity of axitinib based on individual tolerability using dose modification criteria
16042307|NCT02579798|Device|PEEP (positive end-expiratory pressure)|
16042308|NCT02579785|Behavioral|Mhealth intervention|A series of ten automated interactive voice messages will be delivered to the participant's mobile phone over a period of 4 months. Messages will be targeted to the method of contraception the participant is using (no-method, condoms, pills, injectable, implant, copper coil). Messages will support uptake of contraception among no-method users. Messages will support existing users to continue their method and to use it correctly and will also encourage participants who are not happy with their method to switch to a different method. All messages will end with five options: Press 1 to repeat the message, press 2 to listen to recorded information about methods of contraception, press 3 to speak to a counsellor, press 4 to tell me you're fine, press 5 to stop receiving these messages.
16042309|NCT02579772|Drug|N-acetylcysteine|Pharmacological treatment with N-acetylcysteine (NAC): 3 pills of 600 mg of NAC/day orally for 4 days prior to experimental procedures and 1 pill of 600 mg of NAC orally on the day of the experiment.
16042310|NCT02579772|Drug|Placebo|Placebo: 3 placebo pills/day orally for 4 days prior to experimental procedures and 1 placebo pill orally on the day of the experiment.
16042311|NCT02579759|Drug|PXT3003 dose 1|Liquid oral solution, 5 ml twice a day, morning and evening with food
16042312|NCT02579759|Drug|PXT3003 dose 2|Liquid oral solution, 5 ml twice a day, morning and evening with food
16042313|NCT02579759|Drug|placebo|Liquid oral solution, 5 ml twice a day, morning and evening with food
16042314|NCT02579746|Behavioral|DASHNa-CC|The 8-week DASHNa-CC intervention incorporated Dietary Approach to Stop Hypertension (DASH) diet, sodium reduction with the food therapy of Traditional Chinese Medicine, and included an intervention manual, two sessions of classroom instruction delivered in Mandarin, and a 20-minute telephone follow-up.
16042315|NCT02579746|Behavioral|usual care|education booklet, encouragement of physician visit, use of public health resources if needed
16042316|NCT02579733|Drug|Azathioprine|
16042317|NCT02579733|Drug|Placebo|
16042318|NCT02579707|Drug|AG120|AG120 in fed and fasted conditions. Part 2- AG120 single dose exposure
16042319|NCT02579694|Device|Acumed Scapholunate Intercarpal Screw|Evaluation of provisional fixation to allow biologic healing of the scapholunate interval
16042320|NCT02579681|Drug|dimethyl fumarate|dimethyl fumarate administered as per the arm description
16042321|NCT02579668|Other|Language Therapy|
16042322|NCT02579655|Behavioral|Copayment Elimination|Patients will receive preventive medications for their chronic conditions free of charge (without the 30% copayment seniors normally pay for their medications)
16042323|NCT02579655|Behavioral|Personalized Education|Tailored Education focusing on optimizing use and adherence to guideline recommended medications, as well as appropriate lifestyle
16042324|NCT02579642|Drug|Ketamine|Low dose ketamine 0.2 mg/kg (or 0.5 mg/kg depending on results of interim analysis) administered with usual induction drugs for ECT
16042325|NCT02579642|Drug|Placebo|Normal saline administered with usual induction drugs for ECT
16042364|NCT02579369|Device|Polyurethene Film|Dressing for Dystrophic Epidermolysis Bullosa wound.
16042365|NCT02579356|Drug|Telmisartan|
16042366|NCT02579356|Drug|Atorvastatin|
16042396|NCT02579187|Drug|5µg of pSil-miR200c and 5µg of PMIS miR200a|subjects in the experimental group will receive a 5µg of pSil-miR200c and 5µg of PMIS miR200a plasmids in a biodegradable sponge (type I bovine collagen) to stabilize the clot
16042326|NCT02579629|Drug|Ropivacaine 0.1%|Ropivacaine 0.1% is a local anaesthetic drug and will be administered as a single bolus dose of 8ml of 0.1% ropivacaine followed by an infusion of 8ml/hr of 0.1% ropivacaine using the On-Q® elastomeric pump. The bolus dose of 8ml of 0.1% ropivacaine will be administered via a multiport, silver-impregnated catheter (6-10cm) placed above the rectus muscle parallel to the fascial incision, using a preloaded syringe. The infusion will be delivered by the On-Q® elastomeric pump pre-set to deliver 8ml/hr of 0.1% ropivacaine for 72 hours post-operatively.
16042327|NCT02579629|Drug|Ropivacaine 0.2%|Ropivacaine 0.2% is a local anaesthetic drug and will be administered as a single bolus dose of 8ml of 0.2% ropivacaine followed by an infusion of 8ml/hr of 0.2% ropivacaine using the On-Q® elastomeric pump. The bolus dose of 8ml of 0.2% ropivacaine will be administered via a multiport, silver-impregnated catheter (6-10cm) placed above the rectus muscle parallel to the fascial incision, using a preloaded syringe. The infusion will be delivered by the On-Q® elastomeric pump pre-set to deliver 8ml/hr of 0.2% ropivacaine for 72 hours post-operatively.
16042328|NCT02579629|Drug|Normal saline|Normal saline will be administered as a single bolus dose of 8ml of normal saline followed by an infusion of normal saline using the On-Q® elastomeric pump. The bolus dose of 8ml of normal saline will be administered via a multiport, silver-impregnated catheter (6-10cm) placed above the rectus muscle parallel to the fascial incision, using a preloaded syringe. The infusion will be delivered by the On-Q® elastomeric pump pre-set to deliver 8ml/hr normal saline for 72 hours post-operatively.
16042329|NCT02579629|Device|On-Q ® elastomeric pump|The On-Q® elastomeric pump automatically and continuously delivers a regulated flow of 0.1% or 0.2% ropivacaine or normal saline locally to the surgical site for 72 hours post-operatively. The infusion will be delivered by pre-setting the On-Q® elastomeric pump to deliver at the rate of 8ml/hr for 72 hours post-operatively.
16042330|NCT02579616|Drug|Lenvatinib|Lenvatinib will be administered orally once daily in 28-day cycles. Participants will be treated until disease progression, unacceptable toxicity, withdrawal of consent, participant's choice, etc.
16042331|NCT02579603|Drug|Nintedanib|Nintedanib 150mg bid
16042332|NCT02579603|Drug|Pirfenidone|
16042333|NCT02579590|Drug|Depot Medroxyprogesterone Acetate 150 mg|"the DMPA user where they are using Depot Medroxyprogesterone Acetate 150 mg (DMPA; Phrmcia) injection every 3 month"
16042334|NCT02579590|Drug|Implanon( 68 mg etonogestrel implant)|where they are using etonogestrel 68 mg implant (Implanon; Organon)
16042335|NCT02579590|Drug|Cerazette pills (75 micrograms desogestrel)|where they are using desogestrel 75 micrograms (Cerazette; Organon), one pill every day for 28 days without pill-free interval.
16042336|NCT02579577|Other|Observation|Observation of clinic appointments and ward rounds if the child is admitted to hospital during the study period.
16042337|NCT02579577|Other|Interviews|Semi-structured interviews will be conducted approximately 3 times during the study period with each participant.
16042338|NCT02579577|Other|Medical notes review|The child's electronic medical record will be accessed periodically to identify any planned appointments or periods of hospitalisation and their medical notes will also be reviewed at the end of the study.
16042339|NCT02579564|Drug|Gemcitabine|
16042340|NCT02579564|Drug|Vinorelbine|
16042341|NCT02579564|Drug|Paclitaxel|
16042342|NCT02579564|Drug|Pemetrexed|
16042343|NCT02579564|Drug|Oncorine|
16042344|NCT02579564|Drug|Endostar|
16042345|NCT02579564|Drug|Cisplatin|
16042346|NCT02579551|Procedure|Therapeutic Conventional Surgery|Undergo surgical excision
16042347|NCT02579525|Other|Hemodynamical treatment TTP|Based on capillary refilling time, peripheral temperature, mottling, diuresis, MAP safety limit monitoring
16042348|NCT02579525|Other|Hemodynamical treatment MCG|Based on MAP, CVP, urine output monitoring
16042349|NCT02579512|Other|Extra-corporeal ECG signal analysis|The NIA algorithm is similar to the traditional 12-lead ECG equipment. By analyzing patient data, NIA algorithm provides more detailed results compared to traditional 12-lead ECG. Patients with suspected coronary artery disease are conventionally diagnosed and treated by cardiac catheterization. However, cardiac catheterization is invasive procedure. Unless clinical diagnosis is evident before cardiac catheterization, a treadmill exercise test, a nuclear medicine myocardial perfusion test, or a multi-direction coronary CT angiogram is usually performed to increase the accuracy of diagnosis. But these examinations are not accessible to all patients, and are time-consuming and costly.
16042350|NCT02579499|Drug|fixed high potent statin therapy|Patients assigned fixed high-potent statin group will be received high-intensity statin therapy (atorvastatin 40mg or rosuvastatin 20mg) regardless of their baseline LDL-C levels, and maintain high-intensity statin therapy regardless of their follow-up LDL-C level.
16042351|NCT02579499|Drug|targeted LDL-C goal statin|"Statin naïve patients: Patients will be received moderate intensity statin therapy (atorvastatin 20mg or rosuvastatin 10mg)
~Patients already received statin therapy
~Baseline LDL-C <70mg: same intensity of statin therapy
~Baseline LDL-C≥70mg: uptiltrated statin therapy Patients will be tiltrated statin intensity guided by follow-up LDL-C level ( Attained LDL-C < 50mg/dL : down regulated intensity statin therapy, 50mg/dL ≤ Attained LDL-C < 70g/dL: maintain current intensity statin therapy, Attained LDL-C ≥ 70mg/dL: up regulated intensity statin therapy)"
16042352|NCT02579473|Drug|SER-214|SER-214 is a poly(2-ethyl-oxazoline) (POZ) polymer conjugate of the potent dopamine agonist rotigotine that is designed to provide continuous drug delivery following a single weekly injection
16042353|NCT02579460|Other|Cessation of Acid Suppressing Medications|Acid suppressing medications are stopped for all participants the day after baseline assessment. Subsequent evaluations are performed while the participant is not on acid-suppressing medications. Endoscopy with biopsies will be performed in all patients on day 0, 7, and 14.
16042354|NCT02579434|Drug|Midazolam I.V.|Midazolam I.V. 1mg/ml
16042355|NCT02579421|Drug|Progesterone|generic progesterone
16042356|NCT02579421|Drug|placebo|placebo
16042357|NCT02579395|Behavioral|Collaborative implementation Intentions|With spouse/romantic partner
16042358|NCT02579395|Behavioral|Individual implementation Intentions|Without spouse/romantic partner
16042359|NCT02579395|Behavioral|Control|
16042360|NCT02579382|Drug|TDF|300 mg tablets administered orally once daily
16042361|NCT02579382|Drug|Vesatolimod|Tablets administered orally once a week (every 7 days) for 12 doses
16042362|NCT02579382|Drug|Placebo|Placebo administered orally once a week (every 7 days) for 12 doses
16042367|NCT02579343|Device|Auricular Acupuncture|Auricular acupuncture is a form of acupuncture which utilizes the surface of the external ear to identify points of inflammation in the body. It does this, in this case, by utilizing the Pointer Excel II probe which can pick up a change in electrical conductivity on the surface of the ear, which reflects an internal point of inflammation or stress. Once the point of inflammation is identified, the Pointer Excel II is equipped with a sensor that it will not only illuminate by way of a small light on the front of the probe will also identify the point of inflammation by way of an auditory signal. Once the point of inflammation is identified auricular acupuncture will treat that point with a micro-current of electricity for several seconds.
16042368|NCT02579343|Drug|Sham Auricular Acupuncture + Lexapro|Participants will be treated with the SSRI Lexapro 10 mg daily which will be increased to 20 mg daily at week 2. Participants will be treated twice weekly during their follow-up visits with sham auricular acupuncture (No micro-current).
16042369|NCT02579330|Device|Coloshield|Coloshield is designed to occlude the rectum during surgery thus enabling the possibility for rectal washout and maintaining a clear operating field. The rod-shaped Instrument contains two silicon balloons which are inflated by means of a catheter. Several holes at the section in between the two balloons are connected to another catheter, which enable negative pressure to be established. By insufflation of the two balloons and establishment of a negative pressure between the balloons by means of connection to a closed drainage bottle the colon is occluded for the duration of surgery.
16042370|NCT02579330|Other|Control|In the control group no device is introduced but a rectal washout with 500ml of Saline solution in performed.
16042371|NCT02579317|Behavioral|Resonance Breathing|Breathing is paced with a pre-installed iPhone app that includes a visual pacer.
16042372|NCT02579317|Behavioral|Non-Resonance Breathing|Breathing is paced with a pre-installed iPhone app that includes a visual pacer.
16042373|NCT02579304|Procedure|transbronchial lung cryobiopsy|bronchoscopic sampling
16042374|NCT02579291|Other|Dry needling|Once the most painful spot is located within a palpable spastic taut band, the overlying skin is cleaned with alcohol. The needle will be inserted, penetrating the skin about 15-20mm, until the first local twitch response is obtained. Once the first local twitch response is obtained, the needle will be moved up and down (4 to 5 mm. vertical motions with no rotation) in the muscle at approximately 1Hz for 25-30 seconds.
16042375|NCT02579291|Other|Bobath|Patients will receive different neuromodulatory interventions based on the Bobath concept with the aim to decrease spasticity on the lower extremity
16042376|NCT02579278|Other|Blood sample (mrEMVI positive patient)|Two blood samples are taken from each patient with mrEMVI positive tumours post chemoradiotherapy. One pre-surgery and one during surgery from a peripheral vein.
16042377|NCT02579278|Other|Blood sample (mrEMVI negative patient)|
16042378|NCT02579265|Drug|Smoflipid 20% (investigational lipid for parenteral nutrition)|"Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
~Smoflipid 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
~Smoflipid 20% will be infused into a central or a peripheral vein."
16042379|NCT02579265|Drug|Intralipid® 20%|"Dose: The targeted maximal dose is 3.0 g/kg/day. In patients already receiving parenteral nutrition (PN) before starting study treatment, the dose will either stay at 3.0 g/kg/day or be increased by 1.0 g/kg/day steps to a maximum of 3.0 g/kg/day.
~Intralipid® 20% will be infused over 20 - 24 hours, as per hospital policy, at a weight based infusion rate.
~Intralipid® 20% will be infused into a central or peripheral vein."
16042380|NCT02579252|Biological|AADvac1|
16042381|NCT02579252|Drug|Placebo|
16042382|NCT02579239|Biological|ATYR1940|Intrapatient dose escalation of intravenous ATYR1940 administered twice weekly at doses of 0.3, 1.0, or 3.0 mg/kg for up to 12 weeks.
16042383|NCT02579239|Biological|Placebo|Patients will receive an initial infusion of placebo at Week 1, supplied as normal saline and administered via IV infusion over a 30-minute period.
16042384|NCT02579226|Drug|AZD2811|The study will be conducted in 2 parts, dose-escalation (A) and dose-expansion (B). All patients in both parts of the study with receive AZD2811.
16042385|NCT02579213|Other|observational study done only in women candidate for amniocentesis|As a part of routine test in women with obstetrical indication for amniocentesis, we take 30 cc of amniotic fluid. only additional 3 ml of the amniotic fluid are needed for examination by electronic sensors.
16042386|NCT02579200|Device|POWERbreathe®KHA (IMT group)|2 training sessions/day consisting of 30 breaths (~50% maximal inspiratory pressure; Pi,max), 7 days/week (once/week supervised at research center), for 8 weeks using an electronic tapered flow resistive loading (TFRL) device (POWERbreathe®KH2, HaB International Ltd., Southam, UK). Measurements of PImax will be performed every week and training loads will be increased continuously to maintain the actual ~50% Pimax values.
16042387|NCT02579200|Device|POWERbreathe®KH2 (sham group)|2 training sessions/day of 30 breaths at an inspiratory load of no more than 10% of their initial Pi,max (POWERbreathe®KH2, HaB International Ltd., Southam, UK). This training load will not be changed during the entire study period.
16042388|NCT02579187|Procedure|tooth extraction|The study tooth will be removed
16042389|NCT02579187|Radiation|CBCT scan|a CBCT scan limited to the dental arch that includes the study side will be obtained
16042390|NCT02579187|Drug|Anesthesia|all subjects will receive local infiltrative anesthesia, prior to extraction of the tooth
16042391|NCT02579187|Other|clinical measurements|After tooth extraction, clinical measurements of the site will be obtained and recorded (keratinized mucosa width, horizontal ridge width, facial and lingual bone thickness
16042392|NCT02579187|Drug|Biodegradable sponge (type I bovine collagen)|control group subjects will receive a biodegradable sponge (type I bovine collagen) to stabilize the clot
16042393|NCT02579187|Drug|10µg of pSil-miR200c|subjects in the experimental group will receive a 10µg of pSil-miR200c plasmids in a biodegradable sponge (type I bovine collagen) to stabilize the clot
16042394|NCT02579187|Procedure|cross mattress suture|The site will be stabilized with a simplet external, cross mattress suture
16042395|NCT02579187|Drug|10µg of PMIS miR200a plasmids|subjects in the experimental group will receive a 10µg of PMIS miR200a plasmids in a biodegradable sponge (type I bovine collagen) to stabilize the clot
16042474|NCT02578680|Drug|Cisplatin|IV infusion
16042475|NCT02578680|Drug|Carboplatin|IV infusion
16042397|NCT02579187|Procedure|Blood|Subjects will have venipuncture performed to obtain a small blood sample (approx. 2 ml) to assess for miR-200c and PMIS-miR-200a expression and liver function (AST, ALT, bilirubin levels)
16042398|NCT02579187|Other|Photos/videos|subjects will have photos and/or videos of the extraction site and/or implant taken at each visit.
16042399|NCT02579187|Procedure|Wound fluid|a small sample of wound fluid will be obtained from the extraction site in a minimally invasive manner using a paper point at 1, 2, 3 & 4 weeks post extraction
16042400|NCT02579187|Procedure|saliva|approximately 2 mls of saliva will be obtained in a minimally invasive manner at the time of extraction and at 14 weeks post extraction.
16042401|NCT02579187|Radiation|periapical xray|periapical xrays will be obtained at screening, 16 weeks and at 12 month followup time point
16042402|NCT02579187|Other|PVS impression|PVS impressions will be taken to plan the implant placement surgery. This will be done at the screening visit and also at 14 weeks post extraction.
16042403|NCT02579174|Device|Medacta GMK Sphere|
16042404|NCT02579161|Drug|cephalosporins|Looking at the same drugs and doses the variable is the timeframe of the medication
16042405|NCT02579161|Drug|aminoglycoside|
16042406|NCT02579161|Drug|metronidazole|
16042407|NCT02579161|Drug|Clindamycin|
16042408|NCT02579161|Drug|aminoglycoside/ sulbactam|If allergies to above medicines
16042409|NCT02579161|Drug|Fluoroquinolones|
16042410|NCT02579148|Biological|HUCMSC injection|The subjects will receive intracavernous injection of HUCMSC.'
16042411|NCT02579148|Biological|collagen scaffolds/HUCMSC injection|The subjects will receive intracavernous injection of the mixture of collagen scaffolds and HUCMSC respectively.'
16042412|NCT02579135|Behavioral|Safer Sex|Interactive web-based intervention with five modules: motivation, knowledge, attitudes/norms, self-efficacy, and sexual communication skills.
16042413|NCT02579135|Behavioral|Growth Mindsets|Interactive web-based intervention with five modules: mindsets introduction, growth mindsets of intelligence, growth mindsets of self-control, growth mindsets of people, and integrative summary.
16042414|NCT02579109|Other|memory test|
16042415|NCT02579096|Drug|Allopurinol|Patients will be titrated up to the dose that will lower to target uric acid levels.
16042416|NCT02579096|Drug|Febuxostat|Febuxostat will be titrated up to the dose that will lower to target uric acid levels.
16042417|NCT02579096|Drug|Placebo, vehicle control (Febuxostat-shaped)|Placebo in the shape of Febuxostat will be given with Allopurinol
16042418|NCT02579096|Drug|Placebo, vehicle control (Allopurinol-shaped)|Placebo in the shape of Allopurinol will be given with Febuxostat
16042419|NCT02579083|Drug|MB66|10 mg of HSV8-N and 10 mg of VRC01-N monoclonal antibodies per MB66 film
16042420|NCT02579083|Drug|Placebo Film|The placebo film is composed of the identical excipients as MB66 without the monoclonal antibodies.
16042421|NCT02579070|Device|DFUPS|The DFUPS device is a two-camera instrument for capturing images of feet.
16042422|NCT02579057|Drug|Furosemide Injection Solution (SCP-101)|
16042423|NCT02579057|Drug|Furosemide Injection Solution, USP|
16042424|NCT02579044|Drug|Everolimus and lonafarnib|
16042425|NCT02579031|Device|Orsiro|Novel biodegradable-polymer sirolimus-eluting stent used during primary percutaneous coronary intervention
16042426|NCT02579031|Device|Xience|Durable-polymer everolimus-eluting stent used during primary percutaneous coronary intervention
16042427|NCT02579018|Behavioral|One hour supervised exercise session|All participants will participate in a one hour supervised exercise session. Participants will wear a physical activity monitor during the assessment for continuous monitoring of heart rate. Short, intense bouts of exercise will be interspersed with rest periods.
16042428|NCT02579005|Biological|Patients with a living donor|The day of allogeneic cell infusion will be referred to as Day 0 and the n-th day before that, as Day -n. The dose of external radiation will be 15 Gy divided in 3 fractions, from Day -3. Cyclophosphamide, 250 mg/m2 will be given on Day -2. Donors will receive 5 daily doses of GCSF, 10 µg/kg, by subcutaneous injection from Day -4. PBMC will be collected through apheresis on Day 0. A dose of 5 x 10exp7 CD3 cells/kg will be administered. The infused volume will be adjusted to contain this T cell dose.
16042429|NCT02579005|Biological|Patients with a UCB donor|The day of allogeneic cell infusion will be referred to as Day 0 and the n-th day before that, as Day -n. The UCB unit should have at least 4 of 6 HLA compatibility and at least 3 x 10exp6 TNC per kg patient weight. The dose of external radiation will be 15 Gy, divided in 3 fractions, starting on Day -3. Cyclophosphamide, 250 mg/m2 intravenously, will be given on Day -2.
16042430|NCT02578992|Procedure|Head-lift position|A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation.
16042431|NCT02578992|Device|7cm high pillow|A 7 cm high pillow was set beneath the patients' head with head in neutral position for intubation.
16042432|NCT02578979|Device|Electrocardiogram|Patients will receive electrocardiogram for detecting atrial fibrillation - a 5-day routine ECG.
16042433|NCT02578979|Device|Holter|Patients will receive electrocardiogram for detecting atrial fibrillation - a 24-h Holter.
16042434|NCT02578966|Behavioral|Motivational Interview|
16042435|NCT02578966|Other|Traditional health education|
16042436|NCT02578953|Drug|Dutasteride-Test product|Dutasteride Capsules are oblong, opaque, dull-yellow, gelatin capsules. The capsules contain 0.5 mg dutasteride for oral administration. The capsules also contain Butylated Hydroxytoluene, Mono-di-glycerides of Caprylic/Capric Acid (MDC), Gelatin, Concentrated Glycerin, Titanium Dioxide, Iron Oxide Yellow as ingredients. This product will be manufactured by GSK, Poznan.
16042437|NCT02578953|Drug|Dutasteride-Reference product|Dutasteride Capsules are oblong, opaque, dull-yellow, gelatin capsules. The capsules contain 0.5 mg dutasteride for oral administration. The capsules also contain Butylated Hydroxytoluene, Mono-di-glycerides of Caprylic/Capric Acid (MDC), Gelatin, Glycerin, Concentrated Glycerin, Titanium Dioxide, Iron Oxide Yellow as ingredients. This product will be manufactured by Catalent, Beinheim.
16042438|NCT02578940|Drug|18F-Fluciclovine PET CT|Radioligand for PET CT scanning
16042439|NCT02578927|Dietary Supplement|GT+Ex|In this session the volunteers ingested capsules with 2g of powder green tea before exercise
16042440|NCT02578927|Dietary Supplement|PL+Ex|In this session the volunteers ingested capsules with 2g of placebo before exercise
16042476|NCT02578680|Drug|Pemetrexed|IV infusion
16042441|NCT02578927|Dietary Supplement|Green Tea|In this investigation the volunteers ingested capsules with 2g of powder green tea before the rest similar to the exercise time
16042442|NCT02578914|Drug|NS2 Ophthalmic Drops (0.5%)|
16042443|NCT02578914|Drug|NS2 Ophthalmic Drops Vehicle (0.0%)|
16042444|NCT02578901|Drug|Tranexamic Acid|Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, TXA 1.0 gram will be administered. When given PO, TXA 1.3 grams will be administered
16042445|NCT02578901|Drug|Placebo|Doses will be given intravenous (IV) or orally (PO) per the discretion of the treating investigator. Doses are administered every 8 hours. When given IV, Normal Saline will be administered. When given PO, placebo pills will be administered
16042446|NCT02578888|Other|Palliative Therapy|Palliative Therapy
16042447|NCT02578888|Other|Palliative Therapy + idiographic|Ancillary studies
16042448|NCT02578862|Drug|Propofol|
16042449|NCT02578862|Drug|Sevoflurane|
16042450|NCT02578849|Drug|L-DOPA|Patients and healthy controls are recruited to participate in [11C]yohimbine scans before and after L-DOPA challenge.
16042451|NCT02578836|Procedure|Fogel Gastroplasty|The subject will be placed under general anesthesia. The procedure will last approximately 1-2 hours. CO2 will be used rather than air for the insufflation that is required during the procedure to minimize abdominal distention. The physician will place an interrupted suture pattern in a manner which partitions the greater curvature of the stomach from the Angle of His to the level of the incisura, creating a tube-like passage for gastric volume reduction. Afterwards, the remaining gastric volume will be reduced using a circumferential running stitch.The device that will be used to place the stitches is the OverStitch system FDA approved for tissue apposition
16042452|NCT02578823|Device|Arctic Sun®|Core temperature is maintained to 36℃ for 3 days by using the skin attached pad(Arcticgel™) and targeted temperature management(Arctic Sun®).
16042453|NCT02578823|Device|Arcticgel™|
16042454|NCT02578823|Procedure|Conventional antipyretic treatment|Conventional antipyretic treatment for fever includes using of antipyretics, ice packs, circulating fan, and tepid bathing, etc.
16042455|NCT02578797|Drug|Apalutamide|Study drug will be administered orally at a dose level of 240 mg daily (4 x 60 mg tablets) in treatment cycles of 28 days.
16042456|NCT02578784|Device|Angioplasty with drug-coated balloon|"Angioplasty with drug-coated balloon Elutax (Aachen Resonance, Germany)"
16042457|NCT02578784|Device|Angioplasty with plain old balloon|"Angioplasty with plain old balloon Sterling (BostonScientific, Switzerland)"
16042458|NCT02578771|Drug|ZuraPrep with 70% IPA|Apply topically
16042459|NCT02578771|Drug|ZuraPrep without 70% IPA|Apply topically. 0% IPA
16042460|NCT02578771|Drug|ChloraPrep CHG/IPA Teal Tint|Apply topically
16042461|NCT02578771|Other|Normal Saline|Apply topically
16042462|NCT02578758|Behavioral|Transdiagnostic internet-based protocol|Transdiagnostic internet-based protocol is an Internet-based Protocol for ED, which will allow the individual to learn and practice adaptive ways to regulate their emotions from a transdiagnostic perspective. The protocol contains the following components: present-focused emotional awareness, cognitive flexibility, emotional avoidance and emotion-driven behaviors, interoceptive and situation-based emotion exposure, psychoeducation about emotions, motivational enhancement and relapse prevention, which are organized in 12 modules: Emotional disorders and emotion regulation; Motivation for change; Understanding the role of emotions; The acceptance of emotional experiences; Practicing the acceptance; Learning to be flexible; Practicing the cognitive flexibility; The emotional avoidance; Emotion driven behaviors; Accepting and facing physical sensations; Facing emotions in the contexts in which they occur; and Relapse Prevention.
16042463|NCT02578758|Behavioral|Transdiagnostic internet-based protocol + positive affect component|Transdiagnostic internet-based protocol + positive affect component is an Internet-based protocol for ED. This protocol contains several transdiagnostic components (present-focused emotional awareness, cognitive flexibility, emotional avoidance and emotion-driven behaviors, interoceptive and situation-based emotion exposure, psychoeducation about emotions, motivational enhancement and relapse prevention) and a specific positive affect regulation component. These components are organized in 16 treatment modules: Emotional disorders and emotion regulation; Motivation for change; Understanding the role of emotions; The acceptance of emotional experiences; Practicing the acceptance; Learning to be flexible; Practicing the cognitive flexibility; The emotional avoidance; Emotion driven behaviors; Accepting and facing physical sensations; Facing emotions in the contexts in which they occur; Learning to move on; Learning to enjoy; Learning to live; Living and learning; and Relapse Prevention.
16042464|NCT02578758|Other|Waiting List Control Group|Participants in a 18-week waiting list control condition. They will be offered the possibility of receiving the online treatment protocol after the wating list period.
16042465|NCT02578745|Device|Prophylactic NPWT (PICO system)|The PICO NPWT system is a small, lightweight (~126 grams), portable suction device consisting of an electric motor-driven vacuum pump connected to a proprietary super-absorbent adhesive dressing. It is supplied as a pump with two sterile dressing kits and two batteries. Different dressing sizes are available for transverse and vertical incisions ranging from 10 to 40 cm. The PICO pump maintains negative pressure of -80 mmHg (+/-20 mmHg) to the wound surface.
16042466|NCT02578745|Other|Standard Dressing|Standard wound dressing consists of routine postoperative wound dressing consisting of layers of gauze and adhesive tape.
16042467|NCT02578732|Drug|FOLFOXA|"Schema:
~1 cycle = 14 days **It will not be considered a deviation if a cycle or pre-cycle assessment must be adjusted to accommodate scheduling or holidays. Adjustment must be documented with reason to BrUOG**
~Abraxane ®: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.
~Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.)
~It is at the discretion of the treating physician to give Neulasta, 6 mg sq x 1 post treatment
~Antiemetics will be administered as per standard institutional policy."
16042468|NCT02578719|Drug|bupivacaine|marcaine %0.5 20 ml flacon
16042469|NCT02578719|Drug|saline|%0.9 sodium chloride
16042470|NCT02578706|Drug|Clopidogrel|Clopidogrel 75mg
16042471|NCT02578706|Drug|Aspirin|81 mg
16042472|NCT02578706|Drug|Placebo|
16042473|NCT02578680|Biological|Pembrolizumab 200 mg|IV infusion
16042477|NCT02578680|Dietary Supplement|Folic acid 350-1000 μg|Orally; at least 5 doses of folic acid must be taken during the 7 days preceding the first dose of pemetrexed, and folic acid dosing must continue during the full course of therapy and for 21 days after the last dose of pemetrexed.
16042478|NCT02578680|Dietary Supplement|Vitamin B12 1000 μg|Intramuscular injection in the week preceding the first dose of pemetrexed and once every 3 cycles thereafter. Subsequent vitamin B12 injections may be given the same day as pemetrexed administration.
16042479|NCT02578680|Drug|Dexamethasone 4 mg|For prophylaxis; orally twice per day (or equivalent). Taken the day before, day of, and day after pemetrexed administration.
16042480|NCT02578680|Drug|Saline solution|IV infusion
16042481|NCT02578667|Device|Gorbly Compression Device|The compression device provides a way to displace critical structures along the path from skin to target, retract excess body wall tissue, and provide mechanical stabilization in a repeatable and sustainable fashion.
16042482|NCT02578654|Other|Strategies to improve HIV care engagement|"Additional HIV care team daily inpatient round and three telephone calls to remind the upcoming clinic appointment. These interventions are specifically added on routine care during the post-intervention period. The routine care does not include the additional round and the three telephone calls and is assessed during the pre-intervention period."
16042483|NCT02578641|Biological|autologous EBV specific Cytotoxic T cells|The CTL line will be prepared by co-cultivation of the irradiated EBV-LCL with patient PBMC. A proportion of peripheral blood will be used to generate EBV specific CTLs.
16042484|NCT02578641|Drug|combination IV gemcitabine and IV carboplatin (AUC2)|4 cycles for Arm A and 6 cycles for Arm B
16042485|NCT02578628|Other|Patient Engagement|The patient engagement system monitors routine clinical laboratory test results and sends messages to patients and providers when action is indicated, such as when tests are overdue or results require extra clinical attention. Patients receive first class letters directing them to call their provider. Providers receive fax or electronic messages directing them to reach out to the patient to arrange follow-up care.
16042486|NCT02578615|Other|physiotherapy|physiotherapeutic intervention according to the principles of the Spiraldynamik® concept
16042487|NCT02578602|Drug|Gadoxetate Disodium|Given IV
16042488|NCT02578602|Device|Magnetic Resonance Imaging|Undergo MRI with gadoxetate disodium
16042489|NCT02578589|Procedure|Plica resection vs conservative treatment|Plica resection vs conservative treatment
16042490|NCT02578550|Drug|Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide fixed-dose combination (FDC)|A single tablet containing DRV 800 mg, COBI 150 mg, FTC 200 mg and TAF 10 mg will be administered.
16042491|NCT02578550|Drug|Emtricitabine/tenofovir alafenamide FDC|A single tablet containing FTC 200 mg and TAF 10 mg will be administered.
16042492|NCT02578550|Drug|Darunavir|A single tablet containing darunavir 800 mg will be administered.
16042493|NCT02578550|Drug|Cobicistat|A single table containing cobistat 150 mg will be administered.
16042494|NCT02578537|Drug|Ticagrelor|Ticagrelor group:all patients receive ticagrelor (180 mg loading dose, then 90 mg twice daily followed for 30 days). All patients were given aspirin 100 mg per day unless they were intolerant. For those not previously given aspirin, a loading dose of 300 mg was preferred.
16042495|NCT02578537|Drug|Clopidogrel|Clopidogrel group:all patients receive clopidogrel (600 mg loading dose, then 75 mg once daily followed for 30 days). All patients were given aspirin 100 mg per day unless they were intolerant. For those not previously given aspirin, a loading dose of 300 mg was preferred.
16042496|NCT02578524|Other|Survey|
16042497|NCT02578511|Drug|Ixazomib|Patients who have been on stable doses of 6 - MP, vincristine, and methotrexate for a minimum of eight weeks and have at least six months remaining of maintenance are eligible to receive Ixazomib, which will be administered on days 1, 8 and 15.
16042498|NCT02578498|Dietary Supplement|High carbohydrate intake|Carbohydrate intake < 50 gram
16042499|NCT02578498|Dietary Supplement|Low carbohydrate intake|Carbohydrate intake > 250 gram
16042500|NCT02578485|Device|AVideogame|Participants active video game played by a period of 60 minutes, then remain at rest for the evaluation of post-exercise blood pressure for an additional period of 60 minutes.
16042501|NCT02578485|Device|SVideogame|Participants sedentary video game played by a period of 60 minutes, then remain at rest for the evaluation of post-exercise blood pressure for an additional period of 60 minutes.
16042502|NCT02578485|Device|EMIntensity|Participants performed walking on a treadmill at moderate intensity by a period of 60 minutes, then remain at rest for the evaluation of post-exercise blood pressure for an additional period of 60 minutes.
16042503|NCT02578485|Device|EISVideogame|Participants performed walking on a treadmill in intensity similar to the game by a period of 60 minutes, then remain at rest for the evaluation of post-exercise blood pressure for an additional period of 60 minutes.
16042504|NCT02578485|Device|Control|participants remained at rest for a period of 60 minutes, then remain at rest for the evaluation of post-exercise blood pressure for an additional period of 60 minutes.
16042505|NCT02578472|Drug|JNJ-42847922|JNJ-42847922 will be administered as 40 milligram oral capsule (2 capsule*20 mg) in one of the treatment periods.
16042506|NCT02578472|Drug|Zolpidem|Zolpidem will be administered as 1 capsule containing 10 mg in one of the treatment periods.
16042507|NCT02578472|Drug|Placebo|Matching Placebo will be administered orally.
16042508|NCT02578459|Device|Intrathecal Drug Delivery System|The Prometra Pump is a battery-operated, implantable, programmable infusion pump that dispenses pain medication into the intrathecal space through an implanted infusion catheter.
16042509|NCT02578459|Other|Conventional Medical Management|Treatment with conventional medical management will include using standard systemic pain medications such as narcotics, nonsteroidal anti-inflammatory drugs (NSAIDs), and neuropathic medications (examples: gabapentin, Lyrica, Cymbalta) that are typically used to treat pancreatic cancer pain.
16042510|NCT02578446|Device|Uncemented Triathlon Tritanium CR Total Knee System|Primary Total Knee Replacement
16042511|NCT02578446|Device|Cemented Triathlon CR Total Knee System|Primary Total Knee Replacement
16042558|NCT02578069|Device|NOVA Intracranial Sirolimus Eluting Stent System|A sirolimus eluting intracranial stent system with polylactic-co-glycolic acid (PLGA) biodegradable drug carrier and electro-grated polybutyl methacrylate (PBMA) base coating. The stent platform is made of 316L stainless steel.
16042559|NCT02578069|Device|Apollo Intracranial Stent System|A 316L stainless steel balloon-expandable intracranial stent system
16042512|NCT02578433|Behavioral|Mindful Self Compassion|Mindful Self Compassion (MSC) training has its primary focus on developing a friendly relationship with oneself by meditation,conversation with the group and the trainer, informal practice and homework assignments. These relationship is founded on mindfulness; therefore the participants will learn a way concentrate on the present moment. The orginal MSC training by Neff and Germer is well established, this intervention will be a shortened form of the original version and will last for the whole visit of the clinical patients in rehabilitation
16042513|NCT02578433|Behavioral|Progressive Muscle Relaxation|Progressive Muscle Relaxation by Jacobson is a well known relaxation technique where participants learn to recognize the difference between tension and relaxation by tensing and subsequently relaxing the muscles. The trainingw ill last the wohole stay and the control group will also do homework assignments.
16042514|NCT02578420|Other|open-label placebo|"Placebo Cream, openly described as Placebo"
16042515|NCT02578420|Other|deceptive placebo|"Placebo Cream, described as Voltaren, containing Diclofenac"
16042516|NCT02578407|Other|accommodative/vergence therapy|12 weekly accommodative/vergence therapies
16042517|NCT02578394|Drug|Anakinra 100mg and Placebo Depo-Medrone|Anakinra 100mg injection S/C Day 1 to Day 5 and Placebo Depo-Medrone (Lipofundin 3mL) I/M Day 1. Anakinra is an interleukin-1 receptor antagonist. Placebo for Depo-Medrone placebo is Lipofundin MCT/LCT 10%.
16042518|NCT02578394|Drug|Depo-Medrone 120mg and Placebo (Anakinra)|Depo-Medrone 120mg in 3mL. Placebo for Anakinra supplied from manufacturer. 120mg Depo-Medrone I/M Day 1 and Placebo Anakinra 100mg injection S/C Day 1 to Day 5.
16042519|NCT02578381|Device|Boston Scientific Pressure Wire|St Jude Medical Pressure Wire
16042520|NCT02578381|Device|Validation of Boston Scientific pressure wire|
16042521|NCT02578368|Drug|5-Fluorouracil|2600 mg/m², d1 i.v., every 2 weeks
16042522|NCT02578368|Drug|Leucovorin|200 mg/m², d1, i.v., every 2 weeks
16042523|NCT02578368|Drug|Oxaliplatin|85 mg/m², d1, i.v., every 2 weeks
16042524|NCT02578368|Drug|Docetaxel|50mg/m², d1, i.v., every 2 weeks
16042525|NCT02578368|Drug|Trastuzumab|4 mg/kg BW (6 mg loading dose at 1st administration), i.v. for 1 h, d1, i.v., every two weeks
16042526|NCT02578368|Drug|sodium folinate|can be used to replace leucovorin (calcium folinate)
16042527|NCT02578368|Procedure|Surgery|Aim of surgical resection is a complete (R0) resection of the primary tumor and the metastases or a complete macroscopic cytoreduction of the metastases.
16042528|NCT02578342|Device|MRI|Functional Magnetic Resonance Imaging technique measures brain activity by detecting associated changes in blood oxygenation level dependency
16042529|NCT02578329|Behavioral|Intensively advised Mediterranean diet|Mediterranean Diet: fatty fish 3 times/week; legumes 2-3 times/week; vegetables twice/day; fresh fruits twice/day; 30 to 45g olive oil/day; 1-2 glasses red wine/day; less than 150g red meat/week
16042530|NCT02578329|Behavioral|usual low-fat dietary advice|usual low-fat dietary advice for cardiovascular disease
16042531|NCT02578316|Drug|Lenvatinib|"Study phase dosing: participants received an initial single dose of radiolabelled 14C-lenvatinib oral patient dosing solution containing 24 mg of lenvatinib as anhydrous free base and radioactivity of 3.7 millibecquerel (MBq) on Day 1.
~Extension phase dosing: 24 mg of 14C-lenvatinib: 2 x 10mg, and 4 x 1mg or 1 x 4mg tablets once-daily, continuously in each 28-day cycle during extension phase."
16042532|NCT02578303|Other|Vascular flow measurement by PC-MRI|participants will undergo vascular flow measurement by PC-MRI at intra and extracranial levels
16042533|NCT02578290|Other|Clinical Decision Support (CDS)|"A best practices alert (BPA) pop-up screen providing CDS will appear at physician sign-off for all scans scored 1-3, and scans scored 4-6 for which an alternative scan scored 7-9 exists.
~This screen will show the appropriateness score of the original scan order, and will display any alternative scans that are scored 7-9 for the same indications and patient characteristics. It will also display a link to relevant ACR documentation relevant to the selected scan and indication.
~Any time the pop-up alert appears, a checkbox removing the selected scan from unsigned orders will be checked by default."
16042534|NCT02578277|Drug|CYP and transporter probe substrates|Cocktail of CYP (cytochrome P450) and transporter probe substrates
16042535|NCT02578277|Drug|BMS-955176|BMS-955176
16042536|NCT02578277|Drug|BMS-955176 plus CYP and transporter probe substrates|BMS-955176 plus the cocktail of CYP and transporter probe substrates
16042537|NCT02578251|Drug|Paracetamol|
16042538|NCT02578251|Drug|Pethidine|
16042539|NCT02578225|Other|Non interventional study|
16042540|NCT02578212|Other|Placebo|
16042541|NCT02578199|Behavioral|motivational interviewing and nutrition|Motivational Interviewing and Nutritional Counseling
16042542|NCT02578186|Drug|Diphenhydramine Hydrochloride|30 mL at bedtime
16042543|NCT02578186|Drug|Placebo|30 mL at bedtime
16042544|NCT02578173|Device|AVERT PLUS|
16042545|NCT02578160|Procedure|inferior alveolar and lingual nerve block procedure|inferior alveolar and lingual nerve block
16042546|NCT02578147|Behavioral|Mighty Girls|
16042547|NCT02578147|Behavioral|Game Girls|
16042548|NCT02578134|Other|US-guided percutaneous electrolysis|US-guided percutaneous electrolysis consists of the application of a galvanic electrical current with an acupuncture needle in the soft tissue, in this case the symptomatic insertion of the plantar fascia
16042549|NCT02578134|Other|Sham US-guided percutaneous electrolysis|The acupuncture needle will be inserted into the symptomatic plantar fascia but no galvanic electrical current will be applied, the equipment will be turn off. Patients will be blinded to the application of galvanic electrical current.
16042550|NCT02578121|Drug|Ixazomib|4.0 mg will be given on days 1, 8 and 15 of a 28 day cycle
16042551|NCT02578121|Drug|Pomalidomide|4.0 mg will be given on days 1-21 of a 28 day cycle
16042552|NCT02578121|Drug|Dexamethasone|20 mg will be given on days 1, 8, 15 and 22 of a 28 day cycle
16042553|NCT02578108|Procedure|genicular nerve diagnostic block with lidocaine (local anesthetic)|sensory denervation of the knee joint
16042554|NCT02578108|Procedure|genicular nerve radiofrequency ablation|Ablation of the genicular nerves of the knee by radiofrequency energy
16042555|NCT02578095|Drug|VK5211|Capsule
16042556|NCT02578095|Drug|Placebo|Capsule
16042557|NCT02578082|Drug|TD-4208|A single inhaled dose of TD 4208 (175 mcg)
16042560|NCT02578056|Device|Midurethral sling|Anti-urinary incontinence procedure, in a prophylactic way.
16042562|NCT02578043|Drug|Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%|Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% (Taro Pharmaceuticals Inc.)
16042563|NCT02578043|Drug|Onexton™ Gel|Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) (Valeant Pharmaceuticals LLC)
16042564|NCT02578043|Drug|Placebo|Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)
16042565|NCT02578030|Drug|SHP465 12.5mg|
16042566|NCT02578030|Drug|SHP465 25mg|
16042567|NCT02578017|Behavioral|Mobile DOT|Mobile DOT is a multi-dimensional tool that uses automated reminders, adherence feedback messages, incentives, and video observation of medication administration.
16042568|NCT02578004|Other|biochemical and molecular analysis|
16042569|NCT02577991|Drug|Decadron|10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate
16042570|NCT02577991|Drug|Triamcinolone|40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate
16042571|NCT02577978|Device|Medacta GMK posterior stabilized prosthesis|
16042572|NCT02577978|Device|Medacta GMK Sphere prosthesis|
16042573|NCT02577965|Procedure|Percutaneous Coronary Intervention|Thrombus aspiration and histopathological analysis ,Optical Coherence Tomography assessment of culprit vessel during primary PCI, Primary PCI and Drug Eluting Stent (DES) - XIENCE PRIME Everolimus Eluting Coronary Stent implantation in culprit lesion, coronary angiography and OCT assessment at 9 months follow-up
16042574|NCT02577965|Device|XIENCE PRIME Everolimus Eluting Coronary Stent System|Xience Prime Everolimus Eluting Coronary Stent System implantation to treat Acute Myocardial Infarction
16042575|NCT02577939|Behavioral|Interval Exercise Training (IET)|This is a single arm study. All patients receive the intervention of 6 weeks of pre-transplant IET, pre- and post-tests, and data collection via FitBit accelerometer and weekly surveys.
16042576|NCT02577926|Drug|Ruxolitinib|Ruxolitinib is a JAK1/2-specific tyrosine kinase inhibitor (TKI) which has been approved for the treatment of symptomatic myelofibrosis. The compound was shown to be superior to hydroxyurea in reducing splenomegaly and constitutional symptoms.
16042577|NCT02577926|Drug|BAT|BAT is at the choice of the investigator (monotherapy with i.e. hydroxyurea, anagrelide, interferon, busulfan, immunomodulators etc).
16042578|NCT02577900|Device|Acticoat absorbent|Apply Acticoat absorbent daily onto diabetic foot ulcer in 12-week study interval
16042579|NCT02577900|Device|Honey gel sheet|Apply Honey gel sheet daily onto diabetic foot ulcer in 12-week study interval
16042580|NCT02577900|Device|Jelonet|Apply Jelonet daily onto diabetic foot ulcer in 12-week study interval
16042581|NCT02577887|Device|Patients implanted with a St. Jude Medical pacemakers|
16042582|NCT02577861|Procedure|Biopsy from donor eye|Corneal biopsy from undamaged limbus
16042583|NCT02577861|Procedure|Implant of Holoclar|Implant of Holoclar into the eye to be treated after scraping of the fibrovascular pannus
16042584|NCT02577861|Procedure|Ophtalmologic examination|"The following assessments are performed:
~Epithelial defects assessment by fluorescein staining; superficial corneal neo-vascularization assessment; Best-Corrected Visual Acuity; ocular tonometry; slit lamp examination (both corneal endothelium and anterior chamber); conjunctival inflammation (both bulbar and limbal) assessment; corneal sensitivity and involvement assessment; Schirmer's test type I; evaluation of the following symptoms: pain, burning, photophobia."
16042585|NCT02577861|Procedure|Blood sample collection|Standard haematology, biochemistry and Infectious profile (Virology) are assessed
16042586|NCT02577861|Procedure|Digital pictures|At least 4 digital corneal slit lamp photos without fluorescein and at least 4 digital corneal slit lamp photos with fluorescein are taken using digital camera
16042587|NCT02577861|Procedure|ECG|A 12-lead ECG measurement in single recording at screening for safety reason and before each transplantation.
16042588|NCT02577861|Behavioral|Questionnaires|Quality of Life assessment through the NEI VFQ 25and EQ-5D-3L questionnaire (EQ-5D-Y in paediatric population)
16042589|NCT02577861|Procedure|Physical examination and vital signs|A complete physical examination and vital signs (Systolic and Diastolic Blood Pressure (SBP, DBP) and Pulse Rate (PR) must be assessed at each visit (but not at pre-screening and at visit 6)
16042590|NCT02577848|Drug|GLP-1|GLP-1 were taken daily for 7 days
16042591|NCT02577848|Drug|Placebo|Placebo were taken daily for 7 days
16042592|NCT02577835|Device|Ambulatory blood pressure monitoring|Ambulatory blood pressure monitoring with arterial stiffness evaluation at 6-12 month intervals.
16042593|NCT02577822|Device|Taperloc standard length stem|
16042594|NCT02577822|Device|Taperloc short length stem|
16042595|NCT02577809|Drug|Morphine100|100mcg added to the spinal anaesthetic
16042596|NCT02577809|Drug|Morphine50|50mcg added to the spinal anaesthetic
16042597|NCT02577809|Drug|Fentanyl|25mcg Fentanyl added to the spinal anaesthetic
16042598|NCT02577809|Drug|Hyperbaric Bupivicaine|1.8ml 0.5% spinal bupivicaine with dextrose
16042599|NCT02577809|Drug|Indomethacin|100mg Indomethacin suppository
16042600|NCT02577783|Drug|PDD regimen: doxorubicin hydrochloride iposome, bortizomib and dexamethasone|doxorubicin hydrochloride iposome (duomeisu) plus bortizomib (velcade) and dexamethasone (disaimisong)
16042601|NCT02577783|Drug|PAD regimen: bortizomib, dexamethasone and doxorubicin|doxorubicin (duoroubixing) plus bortizomib (velcade) and dexamethasone (disaimisong)
16042602|NCT02577770|Device|acupuncture|therapeutic acupuncture treatment with actual needles
16042603|NCT02577770|Dietary Supplement|200mg caffeine|8g coffee, po
16042604|NCT02577770|Dietary Supplement|400mg caffeine|16g coffee, po
16042605|NCT02577770|Dietary Supplement|Decaffeinated|decaffeinated coffee, po
16042606|NCT02577757|Device|MRI|MRI
16042607|NCT02577744|Other|Noninvasive Ventilation|Noninvasive ventilation for 15 minutes with EPAP set at 10 cmH2O and IPAP adjusted to maintain a tidal volume of 6 ml / kg ideal weight.
16042608|NCT02577744|Other|Expiratory Positive Air Pressure|EPAP through facial mask with valve spring load for 15 minutes set at 10 cmH2O.
16042609|NCT02577731|Other|Bone marrow collection|Bone marrow will be collected from the patient at time of orthopedic repair in the operating room. A second sample may be collected if the patient is required to return to the operating room for further repair of orthopedic injury.
16042702|NCT02577094|Biological|Thymoglobulines|Between the last injection of 90Y-DOTA- hLL2 IgG/hLL2 IgG (J-14) and the allogeneic stem cell transplantation
16042610|NCT02577731|Other|Blood collection|Blood sample collection will be collected from the patient at time of orthopedic repair in the operating room. A second sample may be collected if the patient is required to return to the operating room for further repair of orthopedic injury.
16042611|NCT02577731|Other|Clinical data collection|Clinical data collection will encompass demographic information, past and present medical records, laboratory, microbiology, and all other test results, x-ray, CT, MRI, US and all other imaging test results, records about any medication received during admission, records of physical exam during admission, records of all vital signs and hemodynamic monitoring during admission, records of any procedure or intervention during admission, records of any procedure or intervention during hospital admission, condition at the discharge and discharge facility.
16042612|NCT02577718|Drug|Nitroglycerin-citrate-ethanol (NiCE)|Lock solution instilled in catheter lumens for 2 hours then flushed. Administration for up to 30 days, daily as in-patient or once weekly as out-patient
16042613|NCT02577705|Behavioral|Self Empowerment Groups|The Self Empowerment Groups (SEG) curriculum draws key components from the S.E.L.F. tool within Sanctuary, focusing the four domains: creating personal, emotional, moral and physical safety (S), processing and managing emotions (E), recognizing loss and letting go (L), and developing goals for a sense of future (F). S.E.L.F. establishes a common language that all people who have experienced adversity can use to organize their lives and work towards building stable foundations to support their goals and invest in their potential.
16042614|NCT02577705|Behavioral|Financial Empowerment|The Financial Empowerment curriculum developed for this study consisted of interactive exercises, worksheets, and journal assignments that fostered understanding and practice of banking, building credit and debt management, making the most of one's money, and setting financial goals for oneself and one's family. Content focused on identifying and harnessing the internal and external resources that participants can leverage to begin taking steps towards financial self-sufficiency.
16042615|NCT02577705|Behavioral|Matched Savings|Participants were assisted with opening a savings accounts at a local non-profit federal credit union (with 1:1 matches of up to twenty dollars per month) over the course of 12 months.
16042616|NCT02577692|Other|Oxygen|breathing oxygen
16042617|NCT02577692|Other|Ambient|breathing ambient air
16042618|NCT02577666|Behavioral|Ecologically Based Therapy|6 months of community reinforcement approach and case management, 3 months of rental assistance for housing
16042619|NCT02577666|Behavioral|Housing Only|receives 3 months of project supported rental assistance
16042620|NCT02577666|Behavioral|Treatment as Usual|receives services as normally offered within the community
16042621|NCT02577653|Other|Posturographic evaluation|Subjects will undergo CDP testing using the modified Clinical Testing of Sensory Integration in Balance (mCTSIB) protocol. Subsequently, subjects will be asked to stand first on the right leg and then on the left leg with eyes open. Finally, subjects will be asked to perform 10 repetition of the squatting movement, with the operator pacing them (telling them when to start and when to stop the movements).
16042622|NCT02577640|Dietary Supplement|Soy bread|Soy breads will be produced using a sponge-dough process. Finished dough will be formed, panned, and proofed in proofing cabinet (~95% RH) at 40ºC for 60 minutes. Proofed loaves will be baked for 50 minutes at 150ºC in a convection oven (jet air oven, model: JA14, Doyon, Liniere, Quebec, Canada). Breads will be considered done at an internal temperature of 95 ± 5ºC.
16042623|NCT02577627|Device|PrediCare|
16042624|NCT02577614|Drug|FEIBA|Administration of FEIBA after cardiopulmonary bypass
16042625|NCT02577614|Drug|Normal Saline|Administration of placebo after cardiopulmonary bypass
16042626|NCT02577601|Drug|Ulipristal Acetate|
16042627|NCT02577601|Drug|Levonorgestrel (LNG)/Ethinyl estradiol birth control pill|
16042628|NCT02577588|Biological|re-activated T cells|autologous reactivated T cells against p53
16042629|NCT02577575|Drug|Oxytocin|40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.
16042630|NCT02577575|Drug|Saline Nasal Spray|40 IU of the saline nasal spray will be administered once at the beginning of the visit.
16042631|NCT02577562|Device|Zenith® Fenestrated AAA Endovascular Graft|The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneurysms having morphology suitable for endovascular repair
16042632|NCT02577549|Behavioral|Diet & Exercise|Participants will attend exercise and diet classes.
16042633|NCT02577549|Behavioral|Attention Control|Participants will attend healthy living classes and receive health newsletters and phone calls/emails/texts.
16042634|NCT02577536|Other|No Interventions|No Interventions will be conducted under this study.
16042635|NCT02577523|Drug|ND0612 (Levodopa/Carbidopa solution)|
16042636|NCT02577510|Drug|Nerve Injection- Nerve Stimulator|For the neurostimulation nerve injection technique, the initial puncture site will be located medial to the anterosuperior iliac spine, just caudal to the inguinal ligament [7]. The 22-gauge insulated needle will be connected to a stimulator set at a current of 1.5 mA, a pulse width of 300 ms and a frequency of 2 Hz. A paresthesia referred to the lateral aspect of the thigh at a minimal stimulatory threshold of 0.6 mA (0.3ms) will be sought prior to the injection of local anesthetic [7]. A total of 5cc of 2%Xylocaine will be injected for the nerve injection/anesthesia.
16042637|NCT02577510|Drug|Nerve Injection - Ultrasound|For the ultrasound nerve injection group, after skin disinfection, the inguinal region of patients will be scanned using a high-frequency (6 to 13 MHz) linear array transducer covered with a sterile plastic cover. An ultrasound image showing the inguinal ligament and anterior superior iliac spine (ASIS) will be obtained. Using an out-of-plane technique, a 22-gauge nerve block needle will be inserted 1-2 cm medial to ASIS. The needle will be advanced until its tip rests under the inguinal ligament, immediately ventral to the iliopsoas muscle [6]. A total of 5cc of 2%Xylocaine will be injected for the nerve injection/anesthesia.
16042638|NCT02577497|Drug|beclomethasone|
16042639|NCT02577497|Drug|fluticasone|
16042703|NCT02577081|Other|CAT scan (CT scan)|all patients will pass a CAT scan of ths pelvis and the 2 femurs. No other interventions are required.
16042704|NCT02577068|Drug|Nefopam|Patients undergoing thyroidectomy receive medications depending on the group allocation 30minutes prior to the surgery end; Nefopam 20mg, Propacetamol 2g, and Nefopam 20mg+Propacetamol 2g. In addition, patients will take the same medication every six hours during POD 1.
16042640|NCT02577484|Device|RXi System|"Provide hemodynamic information for the diagnosis and treatment of coronary and peripheral artery disease. The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve or FFR.
~Measurement of FFR requires simultaneously monitoring the blood pressures proximal and distal to a lesion. The RXi system includes a single use catheter (Navvus) with a pressure sensor for acquisition of the distal pressure. The proximal pressure is acquired by the guide catheter via an interface to the hospital hemodynamic monitor.
~The Navvus catheter interfaces to the RXi system console which includes embedded software, a user interface touch screen and associated electronics."
16042641|NCT02577484|Device|Pressure Wire|Provide hemodynamic information for the diagnosis and treatment of coronary and peripheral artery disease. The system is intended for use in catheterization and related cardiovascular specialty laboratories to compute and display fractional flow reserve or FFR.
16042642|NCT02577458|Drug|CM082|CM082 tablets taken orally once a day on 28-day cycles
16042643|NCT02577458|Drug|Everolimus|Everolimus tablets taken orally once a day on 28-day cycles
16042644|NCT02577432|Drug|fentanyl|Give 25 micro grams fentanyl intrathecal with one syringe. Then immediately give 10 mg hyperbaric bupivacaine intrathecally with an other syringe.
16042645|NCT02577432|Drug|fentanyl|Mix 25 micro grams fentanyl with 10 mg hyperbaric bupivacaine in one syringe. Give them intrathecally.
16042646|NCT02577432|Drug|Hyperbaric bupivacaine|Give 25 micro grams fentanyl intrathecal with one syringe. Then immediately give 10 mg hyperbaric bupivacaine intrathecally with an other syringe.
16042647|NCT02577432|Drug|hyperbaric bupivacaine|Mix 25 micro grams fentanyl with 10 mg hyperbaric bupivacaine in one syringe. Give them intrathecally.
16042648|NCT02577419|Other|Target Fortification|
16042649|NCT02577419|Other|Higher Initial Concentration|
16042650|NCT02577419|Other|Portagen Formula|
16042651|NCT02577406|Drug|AG-221|Continuous 28-day cycles of AG 221 100 mg orally (PO) once a day (QD) for 28 days
16042652|NCT02577406|Other|BSC|Best supportive care includes, hydroxyurea for leukocytosis and/or differentiation-like syndrome, anti-infectives, analgesics, antiemetics, antipyretics, transfusions and nutritional support
16042653|NCT02577406|Drug|Azacitidine|continuous 28-day cycles of azacitidine 75 mg/m2/day SC for 7 days, plus BSC
16042654|NCT02577406|Drug|Low-dose cytarabine (LDAC)|continuous 28-day cycles of cytarabine 20 mg SC twice a day (BID) for 10 days, plus BSC
16042655|NCT02577406|Drug|Intermediate-dose cytarabine (IDAC)|28-day cycles of cytarabine 0.5 to 1.5 g/m2/day IV for 3 to 6 days, per standard institutional practice, plus BSC; only BSC given after IDAC therapy concludes per standard institutional practice
16042656|NCT02577393|Drug|EGCG|EGCG (purity≥95% by high pressure liquid chromatography; from Ningbo HEP Biotech Co., Ltd) is dissolved in 0.9% saline solution three times a day. A new batch is made up each time. For esophageal application, repeated swallowing of 10 ml of the EGCG solution is indispensable to assure the prolonged presence of drug the esophageal walls. We choose a dose of 440 lmol/L as the recommended concentration for this study by referring to our previous phase I study. Immediately at the beginning of radiotherapy, the EGCG solution is given until two weeks after radiotherapy completed. Steroids, non-steroidal anti-inflammatory drugs, narcotics, local anesthetics, or other antibiotic/antifungal therapy are not given unless esophagitis progressed to grade 4.
16042657|NCT02577393|Drug|EGCG|EGCG (purity≥95% by high pressure liquid chromatography; from Ningbo HEP Biotech Co., Ltd) is dissolved in 0.9% saline solution three times a day. A new batch is made up each time. For esophageal application, repeated swallowing of 10 ml of the EGCG solution is indispensable to assure the prolonged presence of drug the esophageal walls. We choose a dose of 440 lmol/L as the recommended concentration for this study by referring to our previous phase I study. Patients begin medications as soon as grade 1 esophagitis occurred during radiation according to the RTOG criterion.
16042658|NCT02577393|Drug|mLDG|mLDG (lidocaine 0.16mg/mL, dexamethasone 0.02mg/mL, and gentamycin 0.16mg/mL) dissolved in 0.9% saline solution was administered three times a day. Patients were given oral mLDG solution, and began medications as soon as grade 1 esophagitis occurred during radiation according to the RTOG criterion.
16042659|NCT02577380|Behavioral|IPV/GBV HTC|Participants will be interviewed after receiving their services.
16042660|NCT02577367|Drug|Levothyroxine|Administer Levothyroxine
16042661|NCT02577354|Device|ReActiv8 Implantable Stimulation System (Patient Appropriate Stimulation)|ReActiv8 implanted and configured to deliver stimulation at a patient-appropriate level, and participants instructed to deliver stimulation in two 30-minute sessions per day.
16042662|NCT02577354|Device|ReActiv8 Implantable Stimulation System (Low Stimulation)|ReActiv8 implanted and configured to deliver low stimulation, and participants instructed to deliver stimulation in two 30-minute sessions per day.
16042663|NCT02577341|Drug|Nimotuzumab|Patients received weekly nimotuzumab (200mg, IV) concurrent with chemoradiotherapy.
16042664|NCT02577341|Drug|docetaxel and cisplatin|Patients received weekly docetaxel and cisplatin, each of 1 day's duration,concurrent with chest radiotherapy
16042665|NCT02577341|Radiation|daily RT to the chest|Patients received daily RT to the chest
16042666|NCT02577315|Drug|Empagliflozin|Test Therapy - fixed dose combination of 2 tablets of 12.5 mg Empagliflozin and 500 mg Metformin
16042667|NCT02577315|Drug|Metformin|Test Therapy - fixed dose combination of 2 tablets of 12.5 mg Empagliflozin and 500 mg Metformin
16042668|NCT02577315|Drug|Empagliflozin|Reference Therapy - free combination of 1 tablets of 25 mg Empagliflozin and 1000 mg Metformin
16042669|NCT02577315|Drug|Metformin|Reference Therapy - free combination of 1 tablets of 25 mg Empagliflozin and 1000 mg Metformin
16042670|NCT02577302|Device|CAN-Stim - Protect CAN-Stim System|CAN-Stim subjects will be implanted unilaterally (implantation side is up to the investigators discretion) with the CAN-Stim System. Subjects will be educated on the use of the transmitter and programmer. Therapy will be delivered for a minimum of 8 hours per day for 2 weeks. Subjects who are considered a responder at the 2-week follow-up, will continue therapy and followed for a total of 12 months.
16042705|NCT02577068|Drug|Propacetamol|Patients undergoing thyroidectomy receive medications depending on the group allocation 30minutes prior to the surgery end; Nefopam 20mg, Propacetamol 2g, and Nefopam 20mg+Propacetamol 2g. In addition, patients will take the same medication every six hours during POD 1.
16042706|NCT02577055|Procedure|myomectomy|Surgical ablation of all fibroids
16044592|NCT02563847|Dietary Supplement|300 mL tap water|
16042671|NCT02577302|Device|SNS - InterStim® System|"Subjects randomized to SNS will have their Stage I device implanted and tested during a 2-week period. Stage I will have a tined, quadripolar lead placed in the S3 (preferred) or S4 (alternate) foramen in the standard fashion using fluoroscopic guidance and motor response. Motor responses can include a contraction of the levators (bellows response) with or without plantar flexion of the great toe. Subjects who are not demonstrating an appropriate motor response will not have the device implanted and will be exited from the study.Therapy will be delivered for a minimum of 8 hours per day for 2 weeks. Subjects who are considered a responder at the 2-week follow-up, will receive a full implant and followed for a total of 12 months."
16042672|NCT02577289|Procedure|Evaluation of bone quantity in open sinus lift technique with simultaneous implantation ( Nano crystalline hydroxyapatite)|• The sinus cavity will be augmented with bone graft ( Nano crystalline hydroxyapatite)
16042673|NCT02577289|Procedure|Evaluation of bone quantity in open sinus lift technique with simultaneous implantation (PRF)|platelet rich fibrin (PRF) as sole grafting material in created space (PRF)
16042674|NCT02577276|Device|Tele-motion rehabilitation system|Tele-motion rehabilitation system: Interventions include functional therapeutic exercise and real-time feedback. Clinicians remotely monitor subjects' motor performance using Microsoft Kinect 3D sensor tracking system in their home to record their upper limb and trunk movements as they participate in a variety of functional tasks and motor activities, which are directed by their interaction with a monitor screen in their home using uniquely adapted software to integrate key rehabilitation intervention principles.
16042675|NCT02577263|Other|Quality of life assessment|Quality of life and chemotherapy induced neurotoxicity evaluation
16042676|NCT02577250|Drug|Ketamine|Six infusions of 0.5 mg/Kg of ketamine hydrochloride solution over 2 weeks.
16042677|NCT02577237|Behavioral|In-person education sessions|The intervention will be delivered by a radiation oncology nurse. Each of the four in-person sessions consists of approximately 30 minutes of educational content/simulation that addresses a specific caregiving topic and any issues or concerns that the caregiver may be experiencing.
16042678|NCT02577237|Behavioral|NCI Booklet|Radiation Oncology Nurse will hand participant the NCI booklet
16042679|NCT02577237|Other|Survey|written, qualitative assessments of areas including depression and anxiety, caregiver self-efficacy, care-giver self efficacy for head and neck cancer, health-related quality of life, patient performance status, demographics, and medical history.
16042680|NCT02577237|Other|Interview|A structured series of open-ended questions will be used during a telephone interview with participants at four weeks post radiation treatment.
16042681|NCT02577224|Other|Patient-initiated treatment|Please see Intervention Arm
16042682|NCT02577211|Dietary Supplement|Hipocaloric enteral nutrition|15 kcal/Kg of body weight
16042683|NCT02577211|Dietary Supplement|Normocaloric enteral nutrition|25 kcal/kg of body weight
16042684|NCT02577198|Other|Medilogy Decision Support System (MediDSS)|Italian translation of Evidence-Based Medicine electronic Decision Support (EBMeDS), a set of rules (scripts) based on Evidence Based Medicine guidelines and applied to structured health data. MediDSS further includes knowledge from Swedish, Finnish, INteraction X-referencing (SFINX), a drug-drug interaction database containing concise evidence-based information of about 18,000 drug interactions and adverse events. MediDSS is integrated with local reminders.
16042685|NCT02577185|Drug|Botulinum Toxin Type A|
16042686|NCT02577185|Drug|Sodium chloride 9 mg/ml|
16042687|NCT02577172|Behavioral|Exercise group|The intervention will be conducted during chemotherapy and tailored for each patient. The program will include 1) weight bearing aerobic exercises to maintain the oxygen transport and thereby reduce the decline in VO2max during chemotherapy and 2) strength training exercises to maintain muscle mass and muscle strength. The intervention will last for 9 or 12 weeks, depending on the number of BEP/EP cycles received. The program will consist of two-three one-hour exercise sessions per week, of which most supervised by a personal trainer. The intensity of each exercise sessions will varies from easy (warm-up: 60-70 % of peak heart rate) to moderate/high (between aerobic intervals 60-70% of peak heart rate and during aerobic intervals 85-95 %).
16042688|NCT02577172|Behavioral|Control group|The control group will receive one individual lifestyle counseling session during the first chemotherapy cycle and can perform all activities that they have planned to do during chemotherapy.
16042689|NCT02577159|Drug|Dapagliflozin|Dapagliflozin is orally administered for 8 weeks in the dose of 5mg per day by adding the conventional treatment if there is no serious event included in termination criteria. If the effect for improving diabetes is insufficient, it is allowed to raise its dose up to 10mg/day.
16042690|NCT02577146|Device|renal and bladder ultrasound with ureteral jet assessment|The number of jets from each ureteral orifice will be tabulated over time so that ureteral jet frequency, defined as number of jets per minute, can be calculated. Patients will be categorized into three groups. Group I- no ureteral jets on the symptomatic side; Group II- continuous low-level ureteral jet on the symptomatic side; Group III- ureteral jets similar to nonsymptomatic side.
16042691|NCT02577133|Dietary Supplement|Lactobacillus reuteri DSM 17938|Lactobacillus reuteri DSM 17938 1,000,000,000 CFU per day (5 drops) for 28 days
16042692|NCT02577133|Dietary Supplement|Placebo|The placebo consisted of an identical bottle with distilled water
16042693|NCT02577120|Device|Epiceram Skin Barrier Function|Epiceram is a non-sterile, viscous, lipid-rich emulsion
16042694|NCT02577120|Biological|Vaseline Petroleum Jelly|A skin protectant used for temporarily protecting minor cuts, scraps, burns, and helps to protect and help relieve chapped or cracked skin and lips.
16042695|NCT02577120|Biological|Ceramiseal|Topical serum designed to fortify delicate skin with essential lipids. The proprietary blend of naturally occurring lipids contained in Ceramiseal are designed to improve the barrier function of your skin's outer layer; thereby restoring critical moisture balance and improving physical appearance and function.
16042696|NCT02577107|Drug|ranibizumab|
16042697|NCT02577107|Drug|Conbercept|
16042698|NCT02577094|Drug|90Y-DOTA-Epratuzumab IgG/Epratuzumab IgG|2 injections of 90Y-DOTA- hLL2 IgG- hLL2 IgG at day -21 and day -14. (The 2 drugs are mixted in the same infusion)
16042699|NCT02577094|Drug|Busulfan|Between the last injection of 90Y-DOTA- hLL2 IgG/hLL2 IgG (J-14) and the allogeneic stem cell transplantation
16042700|NCT02577094|Biological|allogeneic stem cell transplantation.|At Day 0
16042701|NCT02577094|Drug|Fludarabine|Between the last injection of 90Y-DOTA- hLL2 IgG/hLL2 IgG (J-14) and the allogeneic stem cell transplantation
16042707|NCT02577055|Procedure|embolisation|Embolisation of the peri-myoma vascular network, with non-resorbable particles of >500 µm diameter, using an ultra thin catheter introduced through the vascular network up to the uterine arteries under radioscopic control.
16042708|NCT02577042|Drug|Raltegravir|Switching the PI by raltegravir 400mg every 12 hours, plus Kivexa or Truvada, for 24 weeks.
16042709|NCT02577042|Drug|PI-based regimen|Continue with the same PI-based regimen, plus Kivexa or Truvada, for 24 weeks.
16042710|NCT02577042|Drug|Atorvastatin|Atorvastatin, 20mg/day, will be added after 24 weeks of study for 48 weeks
16042711|NCT02577029|Drug|ARC-520|ARC-520 will be administered intravenously concomitantly with 0.9% normal saline using an infusion rate of 0.4 mL/min (24 mL/hour) for study treatment and 200 mL/hr for saline.
16042712|NCT02577029|Drug|entecavir|0.5 mg once daily; oral
16042713|NCT02577029|Biological|pegylated interferon alpha 2a|180 mcg; subcutaneous injection once weekly
16042714|NCT02577029|Drug|tenofovir disoproxil|300 mg once daily; oral
16042715|NCT02577029|Drug|antihistamine|All participants will be pre-treated with an oral antihistamine selected by the investigator from the list of approved antihistamines that is available in that country. Acceptable antihistamines are: diphenhydramine 50 mg p.o., chlorpheniramine 8 mg p.o., hydroxyzine 50 mg p.o., or cetirizine 10 mg p.o.
16042716|NCT02577016|Drug|Sitagliptin|50 mg tablet administered orally
16042717|NCT02577016|Drug|Placebo|Placebo to sitagliptin administered orally
16042718|NCT02577016|Drug|Ipragliflozin|50 mg tablet administered orally as background medication
16042719|NCT02577003|Drug|Ipragliflozin|50 mg tablet administered orally
16042720|NCT02577003|Drug|Placebo|Placebo to ipragliflozin tablet administered orally
16042721|NCT02577003|Drug|Sitagliptin|Background medication; 50 mg tablet administered orally
16042723|NCT02576977|Biological|Pembrolizumab|pembrolizumab 200 mg IV infusion
16042724|NCT02576977|Drug|Pomalidomide|pomalidomide 4 mg capsules
16042725|NCT02576977|Drug|Dexamethasone|dexamethasone 40 mg tablets
16042726|NCT02576964|Drug|Capecitabine|Participants will receive oral capecitabine, 1000 mg/m^2 twice daily on Days 1 to 14 of each 21-day cycle, for at least 6 cycles (18 weeks). Treatment may continue until disease progression, intolerable toxicity, or consent withdrawal.
16042727|NCT02576964|Drug|Peginterferon alfa-2a|Participants will receive SC peginterferon alfa-2a, 180 mcg every week during each 21-day cycle, for at least 6 cycles (18 weeks). Treatment may continue until disease progression, intolerable toxicity, or consent withdrawal.
16042728|NCT02576951|Drug|Galcanezumab|Administered SC
16042729|NCT02576951|Drug|Placebo|Administered SC
16042730|NCT02576938|Drug|Baricitinib|Administered orally
16042731|NCT02576938|Drug|Placebo|Administered orally
16042732|NCT02576938|Drug|Triamcinolone (Optional)|Administered topically
16042733|NCT02576925|Other|Clinical, ophthalmological and neurological evaluation|Clinical : questionnaire about the symptoms and about the vascular risk factors Imagery :Cerebral MRI, MRI angiography of the supra-aortic trunks, ECG, Holter, transthoracic echocardiography, Biology : blood count, erythrocytes sedimentation rate, C reactive protein Ophthalomogy : visual field, optical coherence tomography, retinography
16042734|NCT02576912|Drug|Active Delta-9-THC|Active Delta-9-THC (0.036 mg/kg) given intravenously.
16042735|NCT02576912|Drug|Active Pregnenolone|A dose given sublingually.
16042736|NCT02576912|Drug|Placebo|A placebo dose given sublingually.
16042737|NCT02576912|Drug|Placebo|Placebo dose given intravenously.
16042738|NCT02576899|Behavioral|Acceptance and Commitment Therapy for PTSD and Tobacco Use|ACT-PT is an acceptance and mindfulness-based smoking cessation treatment for Veterans with PTSD and tobacco dependence. ACT-PT specifically targets smoking cravings related to PTSD symptoms and memories of trauma, in addition to difficulties managing PTSD symptoms. negative affect and nicotine withdrawal symptoms during quit attempts. ACT-PT includes structured intervention components that guide Veterans to replace smoking as a coping strategy for PTSD symptoms and memories with alternative coping strategies (e.g., mindfulness, acceptance). And healthy living activities (e.g., engaging in work, expanding social networks, engaging in physical exercise) that are consistent with Veterans' values.
16042739|NCT02576899|Behavioral|Freedom From Smoking|The American Lung Association's Freedom from Smoking program (FFS) is a commonly used smoking cessation intervention that is used in community treatment programs.
16042740|NCT02576886|Device|Gamma Camera|All images acquired with the General Electric Discovery 530c
16042741|NCT02576886|Procedure|Prone Imaging|
16042742|NCT02576873|Other|Hemodiafiltration|Hemodiafiltration treatments were prescribed to the patients as their long-term renal replacement therapies
16042743|NCT02576860|Drug|CLS001 (Omiganan)|Topical gel
16042744|NCT02576860|Drug|Vehicle|Vehicle gel
16042745|NCT02576847|Drug|Omiganan|Topical gel
16042746|NCT02576834|Behavioral|Cognitive Therapy for Suicide Prevention|10 sessions of cognitive therapy for suicide prevention provided, along with optional 9 booster sessions + SAU
16042747|NCT02576834|Other|Services as Usual|Services as usually provided in the community
16042748|NCT02576821|Other|Neurological examinations|
16042749|NCT02576821|Other|Neuropsychological examinations|
16042750|NCT02576821|Other|Clinical examinations|
16042751|NCT02576821|Radiation|MRI 3T|
16042752|NCT02576821|Radiation|MRI 7T|
16042753|NCT02576808|Drug|Ginger extract|Ginger extract capsule at dose of 250 mg two times a day after meal daily for 42 days
16042754|NCT02576808|Drug|Loratadine|Loratadine tablet at dose of 10 mg one times a day after morning meal daily for 42 days
16042755|NCT02576795|Biological|valoctocogene roxaparvovec|Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Severe Hemophilia A
16042756|NCT02576782|Drug|Perineural Dexamethasone and bupivacaine|
16042757|NCT02576782|Drug|Systemic Dexamethasone plus perineural bupivacaine|
16042758|NCT02576782|Drug|intravenous saline plus perineural bupivacaine|
16042759|NCT02576769|Other|No intervention|
16042760|NCT02576743|Device|7 Tesla MRI|MR imaging using a 7 Tesla MR system.
16042761|NCT02576730|Procedure|ORIF|surgery for foot and ankle fractures
16042762|NCT02576717|Drug|RPC1063|
16042763|NCT02576704|Device|semi conductor gamma camera|we use a new mathematic technique from entropy analysis to provide precise, objective, automated quantification of perfusion heterogeneity at stress with camera SPECT. This method may be a non-invasive imaging to assess coronary microvascular dysfunction.
16042764|NCT02576691|Device|percutaneous coronary intervention|
16042765|NCT02576678|Drug|Apremilast|
16042766|NCT02576665|Biological|Toca 511|Toca 511 consists of a purified retroviral replicating vector encoding a modified yeast cytosine deaminase (CD) gene. The CD gene converts the antifungal 5-fluorocytosine (5FC) to the anticancer drug 5-FU in cells that have been infected by the Toca 511 vector
16042767|NCT02576665|Drug|Toca FC|"Toca FC is an extended-release formulation of flucytosine. Toca FC is supplied as 500 mg white, oblong tablets with TOCA FC embossed on one side and 500 embossed on the other side"
16042768|NCT02576652|Other|Tetracycline|Treatment during cycle 1 consists of a total oral dose of 1000 mg of tetracycline daily for a total of 3 days.
16042769|NCT02576652|Other|Demeclocycline|Treatment during cycle 2 consists of a total oral dose of 600 mg of demeclocycline daily for 3 days.
16042770|NCT02576652|Procedure|Total Hip Replacement|Participants entering this study were prescheduled to undergo elective THR due to osteoarthritis. Surgery was to be performed according to local standard of care. During THR a fragment of femoral bone was acquired for histomorphometry evaluation.
16042771|NCT02576639|Drug|CNP520|
16042772|NCT02576639|Drug|Placebo|Matching placebo to CNP520 was supplied in capsules.
16042773|NCT02576626|Drug|indacaterol/glycopyrronium 110/50 Breezhaler®|
16042774|NCT02576626|Device|Placebo by Breezhaler®|
16042775|NCT02576626|Drug|ipratropium/salbutamol 0,5 mg, 2,5 mg by nebulisation|
16042776|NCT02576626|Device|Placebo by nebulisation|
16042777|NCT02576613|Other|MPP-S|> 30 weekly sessions of modified psychodynamic psychotherapy in addition to standard treatment
16042778|NCT02576613|Other|TAU|standard medical treatment without structured psychotherapeutic intervention
16042779|NCT02576600|Device|Videopupillometer Algiscan|pupillary diameter measurement every five minutes per-operatively
16042780|NCT02576600|Other|Standard practice|remifentanil administration left to the discretion of the anesthesiologist in charge according to standard practice
16042781|NCT02576600|Drug|Propofol|TCI
16042782|NCT02576600|Drug|Remifentanil|TCI
16042783|NCT02576587|Other|Continuous Positive Airway Pressure|For cases, those found to have moderate sleep apnea (AHI >=15) will be place on CPAP therapy.
16042784|NCT02576574|Drug|Avelumab|Subjects will be administered with avelumab at a dose of 10 milligram per kilogram (mg/kg) 1-hour intravenous (IV) infusion once every 2 weeks until disease progression or unacceptable toxicities.
16042785|NCT02576574|Drug|Pemetrexed|Pemetrexed 500 mg per square meter (mg/m^2) by IV infusion on Day 1 of 3-Week cycle up to a maximum of 6 cycles of IV injection until disease progression or unacceptable toxicities.
16042786|NCT02576574|Drug|Paclitaxel|Paclitaxel 200 mg/m^2 by IV infusion on Day 1 of 3-Week cycle up to a maximum of 6 cycles of IV injection until disease progression or unacceptable toxicities.
16042787|NCT02576574|Drug|Gemcitabine|Gemcitabine 1250 mg/m^2 on Day 1 and Day 8 by IV infusion in 3-Week cycle up to a maximum of 6 cycles when combined with cisplatin of IV injection until disease progression or unacceptable toxicities.
16042788|NCT02576574|Drug|Gemcitabine|Gemcitabine 1000 mg/m^2 on Day 1 and Day 8 by IV infusion in 3-Week cycle up to a maximum of 6 cycles of IV injection when combined with carboplatin until disease progression or unacceptable toxicities.
16042789|NCT02576574|Drug|Carboplatin|Carboplatin AUC 5 mg/mL*min in 3-Week cycle up to a maximum of 6 cycles of IV injection when combined with gemcitabine until disease progression or unacceptable toxicities.
16042790|NCT02576574|Drug|Cisplatin|Cisplatin 75 mg/m^2 by IV infusion in 3-Week cycle up to a maximum of 6 cycles of IV injection until disease progression or unacceptable toxicities.
16042791|NCT02576574|Drug|Carboplatin|Carboplatin AUC 6 mg/mL*min by IV infusion in 3-Week cycle up to a maximum of 6 cycles of IV injection when combined with pemetrexed, or paclitaxel until disease progression or unacceptable toxicities.
16042792|NCT02576574|Drug|Avelumab|Subjects will be administered with avelumab at a dose of 10 milligram per kilogram (mg/kg) 1-hour intravenous (IV) infusion once a week for 12 weeks and then once every 2 weeks until disease progression or unacceptable toxicities.
16042793|NCT02576561|Biological|TVGV-1|Antigen + Adjuvant
16042794|NCT02576561|Biological|GPI-0100|Adjuvant Alone
16042795|NCT02576561|Biological|Placebo|Placebo
16042796|NCT02576548|Biological|MEDI4276|MEDI4276 is an investigational product
16042797|NCT02576535|Procedure|Fractionated stereotactic radiosurgery|
16042798|NCT02576535|Device|Leskell gamma unit|FDA approved device
16042799|NCT02576522|Radiation|brain metastatic patients|Surgery followed by hypofractionated intensity modulated radiation therapy (IMRT) using VMAT approach
16042802|NCT02576496|Drug|Tinostamustine|
16042803|NCT02576483|Behavioral|Questionnaire (QoV questionnaire)|Quality of vision and quality of life questionnaire
16042804|NCT02576470|Behavioral|Biofeedback|Motor learning is improvement in movement overtime, followed by retaining what was learned. To determine whether movements are improving, kinematics must be assessed over time, beginning with defining specific kinematic goals, then continually re-evaluating goals throughout rehabilitation while providing the participants with biofeedback. Biofeedback is fundamental in motor learning, because it increases guidance and motivation, supplements losses in intrinsic feedback (proprioception), and facilitates generalization and retention. Biofeedback enhances the training of novel movements and could be essential for training swallowing maneuvers. Biofeedback training will occur 3 times.
16042805|NCT02576470|Device|Transcranial Direct Current Stimulation|Weak direct currents can be applied non-invasively, transcranially and painlessly. Such application leads to transient changes in corticomotor excitability that are fully reversible. There are no known risks of tDCS of the brain, other than mild local discomfort at the electrode sites.The tDCS sessions will be separated by at least 24hrs, the electrode pads will not be used more than 4 times and they will be clean with a sterile saline solution.
16042849|NCT02576197|Dietary Supplement|Placebo|one capsule per day, containing the placebo, along with the patient's customary psoriasis treatment (excluding systemic treatments)
16042806|NCT02576470|Behavioral|Financial Reward|Motor learning training can be enhanced by adjuvant techniques such as non-invasive neural stimulation and explicit reward. Both influence the primary motor cortex (M1), a key neural substrate of motor skill learning. Non-invasive neural stimulation reduces dysphagia after stroke as measured with subjective swallowing severity scales, however it is unknown whether it could also enhance swallowing maneuver training. Explicit reward (i.e. financial) incentivizes successful gains during motor training. Explicit reward has never been investigated in swallowing rehabilitation. However, it has been shown that increasing stress and financial penalty can reduce swallowing frequency in healthy adults.
16042807|NCT02576470|Behavioral|targeted dysphagia training maneuver|training swallowing maneuvers or compensatory techniques (referred to as targeted dysphagia training throughout this document) that might reduce their swallowing pathophysiology
16042808|NCT02576470|Radiation|Videofluoroscopy (VF) and Barium|The videofluoroscopy (VF) and barium will be used to record swallowing in all participant groups. This will capture full resolution VF images of all subjects in real time in the lateral view. From the digital recording, image sequencing will be exported to an image processing computer system and archived. The image intensifier will be focused on the lips, posterior pharyngeal wall, hard palate, and just below the upper esophageal sphincter (UES), providing a full view of the oral cavity and neck. A simultaneously recorded time-code will facilitate frame-by-frame data analysis. VF is the only option for visualizing swallowing kinematics during the pharyngeal swallow.
16042809|NCT02576470|Device|Transcranial Magnetic Stimulation|Transcranial Magnetic Stimulation (TMS) will be used to provide a single-pulse to the brain.
16042810|NCT02576470|Device|Submental Electromyography|Submental Electromyography (sEMG) is used to train participants swallowing maneuvers.
16042811|NCT02576457|Biological|BMS-936559|
16042812|NCT02576457|Other|Placebo|
16042813|NCT02576444|Drug|AZD2281|Patients will be administered olaparib orally twice daily (bid) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 mL of water.
16042814|NCT02576444|Drug|AZD5363|Patients will be administered AZD5363 at 640 mg twice daily for two days on/five days off (2/7) schedule. Two (2) 200 mg tablets and three (3) 80 mg tablets should be taken twice daily.
16042815|NCT02576444|Drug|AZD1775|The recommended dose will be available no earlier than March 2016.
16042816|NCT02576444|Drug|AZD6738|Patients will be administered AZD6738 at 160 mg daily for days 1-7 of a 28-day cycle (7/28) schedule. AZD6738 is available as 100, 20, and 10 mg tablets. Tablets should be taken daily.
16042818|NCT02576418|Other|Partosure TTD test|PartoSure TTD test and CL will be performed on all patients and the test-to-spontaneous-delivery interval will be calculated.
16042819|NCT02576392|Behavioral|Intervention|Intervention consisted of a mailing 2 weeks prior to surgery, another 2 weeks post surgery, and a pharmacist intervention if a refill of opioid medication was requested within 90 days of surgery.
16042820|NCT02576366|Drug|Voriconazole|
16042821|NCT02576366|Drug|Rifampin|
16042822|NCT02576353|Drug|Fentanyl|Fentanyl Sublingual Spray (FSS)
16042823|NCT02576353|Drug|Fentanyl Citrate|Fentanyl Citrate IV (FCIV)
16042824|NCT02576340|Drug|otilonium bromide|otilonium bromide was administered before the procedure
16042825|NCT02576327|Drug|Tropisetron|Tropisetron Hydrochloride Injection 5mg (Day 1-6)
16042826|NCT02576327|Drug|Dexamethasone|Dexamethasone Sodium Phosphate Injection 10mg (Day 1-6)
16042827|NCT02576327|Drug|Aprepitant|Aprepitant 125mg （Day1-2）, 80mg (Day 3-6)
16042828|NCT02576314|Drug|sofosbuvir and daclatasvir|Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60 mg tablet administered orally once daily.
16042829|NCT02576314|Drug|ledipasvir/sofosbuvir|"Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed dose combination (FDC) tablet administered orally.
~once daily;"
16042830|NCT02576301|Drug|Phase 1 - OXi4503|Determination of MTD of OXi4503
16042831|NCT02576301|Drug|Phase 1 - OXi4503 + cytarabine|Determination of MTD of the combination of OXi4503 + cytarabine
16042832|NCT02576301|Drug|Phase 2 - OXi4503 + cytarabine|Safety and efficacy of the combination of OXi4503 + cytarabine in subjects with AML
16042833|NCT02576301|Drug|Phase 2 - OXi4503 + cytarabine|Safety and efficacy of the combination of OXi4503 + cytarabine in subjects with MDS
16042834|NCT02576288|Drug|Sitagliptin|anti-inflammatory properties
16042835|NCT02576288|Drug|Placebo|No anti-inflammatory properties
16042836|NCT02576275|Drug|Duvelisib|Duvelisib (25 mg BID) administered orally in 28-day continuous treatment cycles
16042837|NCT02576275|Drug|Placebo|Matching placebo (25 mg BID) administered orally in 28-day continuous treatment cycles
16042838|NCT02576275|Drug|Rituximab|IV infusion of rituximab (375 mg/m2) on Day 1 of Cycles 1-6.
16042839|NCT02576275|Drug|Bendamustine|IV infusion of bendamustine (90 mg/m2) on Day 1 and Day 2 of Cycles 1-6.
16042840|NCT02576262|Procedure|TCT，HPV，colposcopic inspection|
16042841|NCT02576249|Drug|Ropivacaine|4cc 0.5% ropivacaine
16042842|NCT02576249|Drug|Normal saline|4cc of sterile normal saline (0.9%)
16042843|NCT02576249|Drug|Methylprednisolone|1cc 40mg methylprednisolone
16042844|NCT02576236|Other|Quadruple concomitant therapy treatment|"Quadruple concomitant therapy treatment:
~high dose PPI (Esoméprazole 40 mg X 2 / d- amoxicillin 1gX2 / d - - clarithromycin 500mgX2 / d - metronidazole 500mgX2 / d for 14 days"
16042845|NCT02576236|Other|Triple therapy guided by the result of the molecular resistance test|"Triple therapy guided by the result of the molecular resistance test:
~If clarithromycin S : high dose PPI (Esoméprazole 40mg X 2/ d) - amoxicillin 1gX2 / d - clarithromycin 500mgX2 / d The total duration of treatment is 14 days.
~If clarithromycin R: high dose PPI (Esoméprazole 40mg X 2/ d) - amoxicillin 1gX2 / d- levofloxacin 500mg X2 / d The total duration of treatment is 14 days."
16042846|NCT02576223|Drug|Ropivacaine hydrochloride|Ropivacaine injected perineural at the suprascapular nerve.
16042847|NCT02576223|Drug|Isotonic Saline|Saline injected perineural at the suprascapular nerve.
16042848|NCT02576197|Dietary Supplement|Probiotic|one capsule per day, containing the probiotic along with the patient's customary psoriasis treatment (excluding systemic treatments)
16044842|NCT02562170|Device|Protexa|
16042850|NCT02576184|Device|Biologic Mesh|Biologic mesh placed in retromuscular position during ileostoma closure
16042851|NCT02576184|Device|Synthetic Mesh|synthetic mesh placed in retromuscular position during ileostoma closure
16042852|NCT02576171|Behavioral|Group-therapy + ICBT|The group therapy supported ICBT treatment program is a combined web-based and face-to-face intervention that will involve adolescents as well as their parents. The program is founded on and inspired by previously evaluated and evidence-based interventions. Altogether, adolescents go through 12 chapters/sessions, 3 of which are face-to-face group sessions at the research clinic, and 9 of which are web-bases chapters. The program is divided into three different phases, starting with psychoeducation regarding social anxiety and the rationale for a cognitive behavioral intervention. Phase two is the main part of treatment and contains behavioral interventions, mainly exposure and habituation to feared situations and/or stimuli.
16042853|NCT02576158|Procedure|TCT，HPV，colposcopic inspection|
16042854|NCT02576145|Biological|DT|Diphtheria and Tetanus Toxoid (DT) will be administered intramuscularly as a 1/3 dilution (0.33 flocculation units). The participants will be rechallenged with DT 6 months after Day 29 if failed to show >=1.5 fold increase in lymphocyte proliferative response but have a humoral response.
16042855|NCT02576145|Drug|Daclizumab|The fifth dose (1 milligram per kilogram [mg/kg]) of daclizumab will be administered in this study to participants who already received four doses (one dose at 1 mg/kg within 24 hours post-transplant and then every other week for 3 doses).
16042856|NCT02576145|Biological|KLH|KLH will be administered intradermally with a dose of 250 mcg for participants aged 2 to less than 12 years, and 500 mcg for participants aged 12 to 19 years. The participants will be rechallenged with KLH 6 months after Day 29 if failed to show specified increase in lymphocyte proliferative response or humoral response.
16042857|NCT02576119|Drug|BMS-955176, Placebo (Part 1)|The BMS-955176 dose in sentinel Cohort 1 will be 240 mg orally. The BMS-955176 dose in sentinel Cohort 2 will be determined based on the results of data from sentinel Cohort 1.
16042858|NCT02576119|Drug|BMS-955176, Moxifloxacin, Placebo (Part 2)|Subjects will be randomized to 1 of 12 sequences. Each sequence includes combination of different regimens (combination of BMS-955176, placebo and Moxifloxacin).
16042859|NCT02576106|Device|Cryoablation|
16042860|NCT02576093|Drug|0.1% WOL071-007|Application of approximately 2 mg cream/cm² skin to a defined surface area. SAD part: Single application to ≤ 100 cm² of non-lesional or lesional skin; MAD part: Multiple application (6 Days) to 2000 cm² of lesional and non-lesional skin.
16042861|NCT02576093|Drug|0.3% WOL071-007|Application of approximately 2 mg cream/cm² skin to a defined surface area. SAD part: Single application to ≤ 100 cm² of non-lesional or lesional skin; MAD part: Multiple application (6 Days) to 2000 cm² of lesional and non-lesional skin.
16042862|NCT02576093|Drug|1.0% WOL071-007|Application of approximately 2 mg cream/cm² skin to a defined surface area. SAD part: Single application to ≤ 100 cm² of non-lesional or lesional skin; MAD part: Multiple application (6 Days) to 2000 cm² of lesional and non-lesional skin.
16042863|NCT02576093|Drug|Placebo of WOL071-007|Application of approximately 2 mg cream/cm² skin to a defined surface area. SAD part: Single application to ≤ 100 cm² of non-lesional or lesional skin; MAD part: Multiple application (6 Days) to 2000 cm² of lesional and non-lesional skin.
16042864|NCT02576080|Drug|Imatinib|
16042865|NCT02576080|Other|Surveillance|The Experimental Group will receive the same thoraco-abdominal and pelvic CT scan.
16042866|NCT02576067|Drug|Low dose methotrexate|Study participants will additionally receive 1 mg daily oral folate.
16042867|NCT02576067|Drug|Placebo|
16042868|NCT02576054|Biological|V501|Quadrivalent HPV [Type 6, 11, 16 and 18] L1 VLP vaccine), 0.5 mL intramuscular injection on Day 1, Month 2, and Month 6
16042869|NCT02576041|Drug|Bilastine|Bilastine tablets once a day for 7+3 days
16042870|NCT02576041|Drug|Placebo|Placebo tablets once a day during 7+3 days run in period
16042871|NCT02576028|Other|Fascial Manipulation® (FM)|Fascial Manipulation® (FM) is a manual therapy that focus on the deep muscular fascia. This technique considers the fascia as a three-dimensional continuum. The mainstay of this manual technique lies in the identification of specific localised areas of the fascia, defined Center of Coordination (CC), where the gliding of the subcutis should be preserved to avoid biomechanical in-coordination of the surrounding muscles. The method is performed by applying a deep friction over the CCs that result more altered at the clinical palpation
16042872|NCT02576028|Other|standard active exercises|two sessions of 45 minutes of active exercises
16042873|NCT02576015|Procedure|peri-operative continuous femoral nerve block with light sedation|this technique will be administered to participants in group L .The puncture site was identified using ultrasound guidance (2 cm distal to the inguinal ligament, and 1 ～2 cm lateral to the femoral artery).2% lidocaine was used for topical anesthesia, then an insulated needle (Contiplex B Braun, Melsungen, Germany) (20 G*45 mm，short bevel，30°) was connected to the nerve stimulator（Innervator，Fisher &Paykel，New Zealand）.The parameters were as follows: stimulating intensity of 1 mA at a rate of 2 Hz. The needle was advanced at 30°～45° angle to the skin, until quadriceps femoral muscle twitches were elicited. Its position was accepted if contractions were still elicited when an output equal to 0.3 mA.The participants will receive continuous femoral nerve block intra-operatively and post-operatively till 3 days post-operatively.The depth of anesthesia will modulated at 50-60 with BIS monitoring
16042874|NCT02576015|Procedure|post-operative continuous femoral nerve block|this technique will be administered to participants in group D .The puncture site was identified using ultrasound guidance (2 cm distal to the inguinal ligament, and 1 ～2 cm lateral to the femoral artery).2% lidocaine was used for topical anesthesia, then an insulated needle (Contiplex B Braun, Melsungen, Germany) (20 G*45 mm，short bevel，30°) was connected to the nerve stimulator（Innervator，Fisher &Paykel，New Zealand）.The parameters were as follows: stimulating intensity of 1 mA at a rate of 2 Hz. The needle was advanced at 30°～45° angle to the skin, until quadriceps femoral muscle twitches were elicited. Its position was accepted if contractions were still elicited when an output equal to 0.3 mA.The participants will receive continuous femoral nerve block post-operatively till 3 days post-operatively.The depth of anesthesia will modulated at 30-40 with BIS monitoring
16042875|NCT02576015|Drug|lidocaine|
16042876|NCT02576015|Device|ultrasound|
16042877|NCT02576015|Device|insulated needle (Contiplex B Braun, Melsungen, Germany)|
16042878|NCT02576015|Drug|ropivacaine|
16042879|NCT02576015|Drug|saline|
16042880|NCT02576002|Drug|Assigned pulmonary hypertension medication|As assigned by treating physician; may include following product classes: - Calcium channel blockers/antagonists - Prostanoids (prostaglandins, thromboxanes, prostacyclines) - Endothelin receptor antagonists - PDE-5 inhibitors - SGc stimulators
16042881|NCT02575989|Other|1: control group|Classic - current management of trauma patients by French medical teams
16042882|NCT02575989|Other|2: interventional group|"Intervention Name : monitoring, treatment, control and prevention of hypothermia
~Continuous monitoring of body temperature
~Ambulance warming (target : 30°C)
~Patient warming with dedicated blanket
~Infusion fluid warming (and temperature control)"
16042883|NCT02575976|Behavioral|comprehensive CR|In the comprehensive CR arm, 24 sessions education will be offered, of 30 minutes duration beyond the exercises already performed in the cardiac rehabilitation program (The main program is 6 months in duration, with 36 1-hour exercise sessions)
16042884|NCT02575976|Other|exercise-based CR|The main program is 6 months in duration, with 36 1-hour exercise sessions.
16042885|NCT02575976|Other|wait list control|No cardiac rehabilitation.
16042886|NCT02575963|Drug|Cytarabine (Phase 1 only)|Low dose cytarabine administered at 20 mg subcutaneously every 12 hours for the first 10 days (Days 1 to 10) of every cycle. Cycle 1 can last up to 52 days (depending on the schedule of study drug dosing) in order to allow for recovery from Lintuzumab-Ac225. Cycles 2-12 will last 28 days each.
16042887|NCT02575963|Biological|Lintuzumab-Ac225|In Phase 1 the starting dose level was 1.0 μCi/Kg of Lintuzumab-Ac225 and 15 μg/Kg unlabeled HuM195 divided into 2 equal fractionated doses (0.5 μCi/Kg and 7.5 μg /Kg + 0.5 μCi/Kg and 7.5 μg /Kg) with the first fraction administered approximately 4-7 days after 1 cycle of low dose cytarabine and the second fraction administered 4-7 days after the first fraction, followed by up to 11 more cycles. In Phase 2 the dose will be 4.0 μCi/Kg Lintuzumab-Ac225 and 25 μg/Kg unlabeled HuM195 divided into 2 equal fractions with the first fraction given on Day 1 and the second fraction given on Day 5-8.
16042888|NCT02575963|Drug|Furosemide (Phase 1 only)|40 mg by mouth daily one day prior to treatment with Lintuzumab-Ac225 and continuing for 10 days following administration of the 2nd divided dose.
16042889|NCT02575963|Drug|Spironolactone|25 mg by mouth daily, administered 10 days after second dose of 225Ac-HuM195 and continued for 12 months.
16042890|NCT02575950|Drug|LEO43204|
16042891|NCT02575950|Drug|Placebo|
16042892|NCT02575937|Behavioral|low glycemic diet|nutrition education-based low glycemic diet intervention
16042893|NCT02575924|Drug|sequential medium|administration of Quinn's Advantage® Fertilization Medium on day0 administration of Quinn's Advantage® Cleavage Medium from day0 to day3 administration of Quinn's Advantage® Blastocyst Medium from day3 to day7
16042894|NCT02575924|Drug|1-step medium|administration of SAGE 1-Step™ with Human Albumin Solution, from day0 to day7
16042895|NCT02575911|Device|Femtosecond Laser System|Used for the creation of a corneal flap in patients undergoing LASIK surgery
16042896|NCT02575911|Procedure|LASIK surgery|
16042897|NCT02575898|Other|First Session|Creative Practice and Positive Re-enforcement
16042898|NCT02575898|Other|Second Session|Disease Related
16042899|NCT02575898|Behavioral|Third through Sixth Sessions|Life Review and Legacy
16042900|NCT02575885|Other|Electronic Cigarette|Receive different type of ENDS product at each visit
16042901|NCT02575885|Other|Electronic Cigarette|Receive BLU e-cigarette ENDS product
16042902|NCT02575885|Other|Laboratory Biomarker Analysis|Correlative studies
16042903|NCT02575885|Other|Pharmacological Study|Correlative studies
16042904|NCT02575885|Other|Questionnaire Administration|Ancillary studies
16042905|NCT02575872|Behavioral|Exercise Intervention|Participate in physical activity behavioral intervention
16042906|NCT02575859|Drug|adjuvant HIPEC|Closed-abdomen HIPEC with cisplatin (25 mg/m2/l of perfusate) and mitomycin-C (3•3 mg/m2/l of perfusate) at 42•5°C for 60 minutes. Perfusate volume: 4-6 l.
16042907|NCT02575859|Procedure|surgery|Colon resections for primary tumors were performed according to the oncologic principles of adequate lymph-adenectomy. Complete adhesiolysis, resection of falciform hepatic ligament, greater and lesser omentectomy were performed in all patients to ensure optimal perfusion during the HIPEC. Tumor deposits on visceral and parietal surfaces were surgically removed by formal peritonectomy procedures and/or organ resections, as needed.
16042908|NCT02575846|Dietary Supplement|Enteral Intake - Human Milk|Comparing formula and human milk
16042909|NCT02575846|Dietary Supplement|Enteral Intake - Formula|Comparing formula and human milk
16042910|NCT02575833|Drug|Erenumab|A single dose of erenumab 140 mg infused over approximately 60 minutes.
16042911|NCT02575833|Drug|Placebo|A single dose of a matching volume of placebo infused over approximately 60 minutes.
16042912|NCT02575820|Procedure|Old red blood cells transfusion|Red blood cells (shelf life > 14 days) transfusion during the operation (total hip replacement arthroplasty)
16042913|NCT02575820|Procedure|New red blood cells transfusion|Red blood cells (shelf life =< 14 days) transfusion during the operation (total hip replacement arthroplasty)
16042914|NCT02575807|Biological|CRS-207|via IV infusion
16042915|NCT02575807|Drug|Epacadostat|PO BID
16042916|NCT02575807|Biological|Pembrolizumab|via IV infusion
16042917|NCT02575794|Drug|Terameprocol|Given PO
16042918|NCT02575794|Other|Pharmacological Study|Correlative studies
16042919|NCT02575781|Drug|SAR428926|Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous
16042920|NCT02575768|Other|Adenosine-stress cardiac magnetic resonance imaging|undergoing adenosine-stress cardiac magnetic resonance imaging
16042921|NCT02575755|Drug|Azithromycin plus piperaquine phosphate|
16042922|NCT02575755|Drug|Sulfadoxine-pyrimethamine|
16042923|NCT02575742|Device|3D-Transit system|
16042924|NCT02575729|Drug|betamethasone|Inject betamethasone on the wrist for patient with carpal tunnel syndrome with sonography- guided, directly.
16042925|NCT02575716|Device|Videolaryngoscope|Intubation with McGrath video laryngoscope after muscle relaxant
16042926|NCT02575703|Drug|[¹⁴C]-LY3023414|LY3023414 in solution containing approximately 100 microCi [¹⁴C]-LY3023414
16042927|NCT02575690|Dietary Supplement|Spirulina|Individuals receive 2 g of spirulina daily, for 3 months.
16042928|NCT02575690|Other|Placebo|Individuals receive a placebo daily, for 3 months.
16042933|NCT02575638|Drug|CZ48|CZ48 is an analog of the topoisomerase I inhibitor Camptothecin (CPT). CPT is a natural extract from the tree Camptotheca acuminata
16042934|NCT02575625|Device|Fibroscan|Three series oh independent measures Measure done with Fibroscan will be preceded by tracking ultrasonography.
16042935|NCT02575625|Biological|Blood test for biological assessment of liver function|Blood test for biological assessment of liver function
16042936|NCT02575625|Device|MRI|Liver MRI
16042937|NCT02575612|Procedure|vacuum-assisted biopsy|Ultrasound guided VAB was used directly prior to breast conserving surgery or mastectomy. It was performed by experienced physicians (> 50 ultrasound guided minimal invasive biopsies per year, > 500 breast ultrasound examination of the breast per year). The needle was placed below or beside the target lesion according to physician's choice. At least six biopsies should be taken; up to 12 according to the physicians choice. After the VAB a clip marker was placed to highlight the position of the biopsy for specimen radiography and pathology.
16042938|NCT02575599|Behavioral|Guided self-determination programme (GSD)|The GSD intervention consist of four e-consultations with structured reflection sheets. Reflection sheets are intended to increase patients' ability to express their views and prepare them for active participation in the care process. Through the web-based platform, the subsequent four e-consultations will allow for communication between patients and nurses. The platform allows the participants to fill in the reflection sheets using their own words and drawings to express their own experiences with self-management as well as to formulate behavioral goals and plans to achieve their goals. It also permits feedback from the nurses on these reflections sheets via secure emails. Each person will be able to access the web-based program from his or her own computers or other electronic devices.
16042939|NCT02575586|Device|Intervention-Dry Needling|"Deep Dry Needling into the site of the latent medial Myofascial Trigger Point of the soleus muscle.
~1 session in soleus muscle moving the needle up and down ten times."
16042940|NCT02575586|Device|Control-Dry Needling|"Deep Dry Needling distal to Myofascial Trigger Point but into the same taut band.
~1 session in soleus muscle moving the needle up and down ten times."
16042941|NCT02575573|Other|Factors influencing resuscitation decisions of patients|
16042942|NCT02575573|Other|Factors leading to not asking patients about resuscitation preference|
16042943|NCT02575560|Other|history data|history data of PFS after 1st line or second line theray
16042944|NCT02575547|Drug|cisplatin and docetaxel|"NC：cisplatin 75 mg/m2 intravenous infusion in day1，docetaxel 75 mg/m2 intravenous infusion in day1，both drugs are given every 3 weeks, two courses.
~CCRT: intensity modulation radiation therapy(IMRT) and cisplatin (100mg/m2 on day 1) every three weeks for three\three cycles during radiation therapy(RT).
~Dietary supplement: enteral nutrition and parenteral nutrition"
16042945|NCT02575534|Drug|Procainamide|the procainamide will be infused at 12mcg/kg up to a max of 1 gram at a rate of 20mg/min which will take up to 1 hour to infuse
16042946|NCT02575521|Drug|Propofol-Dexmedetomidine group|Porofol (1.5-2 mg/kg/h) infusion, Dexmedetomidine (0.2-1µg/kg/h) infusion and Fentanyl in repeated doses (50µ) when needed (heart rate or mean arterial blood pressure increase more than 20% of the basal value). Maintenance infusions will start immediately after induction.
16042947|NCT02575521|Drug|Sevoflurane group|Sevoflurane at a concentration of 2-2.5%., Fentanyl in repeated doses (50µ) when needed (heart rate or mean arterial blood pressure increase more than 20% of the basal value).
16042948|NCT02575508|Drug|Fluorouracil|Given IV
16042949|NCT02575508|Drug|Irinotecan Hydrochloride|Given IV
16042950|NCT02575508|Other|Laboratory Biomarker Analysis|Correlative studies
16042951|NCT02575508|Drug|Oxaliplatin|Given IV
16042952|NCT02575508|Drug|pan FGFR Kinase Inhibitor BGJ398|Given IV
16042953|NCT02575508|Other|Pharmacological Study|Correlative studies
16042954|NCT02575495|Drug|7 days course of antibiotic treatment|start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 7 days
16042955|NCT02575495|Drug|14 days course of antibiotic treatment|start specific intravenous antibiotic therapy as microbiological susceptibility from urine culture for 14 days
16042956|NCT02575482|Drug|SUVN-D4010|
16042957|NCT02575482|Drug|Placebo|
16042958|NCT02575456|Biological|Ebola Vaccine|
16042959|NCT02575456|Biological|Placebo|control
16042960|NCT02575443|Drug|Rocuronium (MB group)|Count of train-of-four: 1-2 Titration of rocuronium dose
16042961|NCT02575443|Drug|Rocuronium (DB group)|Post-tetanic count: 1-2 Titration of rocuronium dose
16042962|NCT02575430|Other|No treatment: retrospective chart review|
16042963|NCT02575417|Behavioral|Conversation Game|The game consists of 47 question cards that prompt players to identify and articulate their values and beliefs related to dying and end-of-life issues; 20 questions have been selected for this study
16042964|NCT02575404|Drug|GR-MD-02|Patients will receive five doses of GR-MD-02 intravenously over 85 Days.
16042965|NCT02575404|Drug|Pembrolizumab|Patients will receive five 200mg doses of pembrolizumab intravenously over 85 days. After 85 days, patients may continue to receive pembrolizumab every 3 weeks if clinical benefit is noted.
16042966|NCT02575391|Dietary Supplement|Whole Food Intervention|A combination of honey, glutamine, probiotics, and butter was administered to participants undergoing cancer.
16042967|NCT02575378|Drug|Metronimic chemotherapy plus Chinese Traditional Medicine|Capecitabine 300mg/m2, twice a day, everyday plus Chinese Traditional Medicine
16042968|NCT02575378|Drug|Metronimic chemotherapy|Capecitabine 300mg/m2, twice a day, everyday
16042969|NCT02575365|Drug|0,5 mg Fingolimod|0.5 mg p.o fingolimod daily
16042970|NCT02575339|Drug|MLN0128|Phase I Dose Escalation Study Cohort 1 MLN0128 15mg QW; Cohort 2 MLN0128 20mg QW; Cohort 3 MLN0128 30mg QW
16042971|NCT02575339|Drug|MLN0128 (RP2D)|"Phase II Arm A:
~MLN0128 administered orally at the recommended phase II dose (RP2D) once weekly."
16042972|NCT02575339|Drug|Sorafenib|"Phase II Arm B:
~Sorafenib administered at 400mg PO BID daily"
16042973|NCT02575326|Other|Standard Control|Teens in the control group will receive standard or usual care as provided by their physician.
16042974|NCT02575326|Behavioral|a provider administered, tailored discussion guide|Teens in the intervention group will receive a provider administered, tailored discussion guide based on motivational interviewing techniques.
16043014|NCT02575027|Radiation|Radiation Therapy Treatment Planning and Simulation|Undergo 4pi radiation simulation and planning
16042975|NCT02575313|Dietary Supplement|Whole Food Intervention|A combination of honey, glutamine, probiotics, and butter was administered to participants undergoing cancer.
16042976|NCT02575300|Drug|Ibrutinib|Ibrutinib will be administered orally once daily and each cycle will be defined as 4 weeks duration. Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent.
16042977|NCT02575287|Device|Optical Enhancement|A endoscopic visualization of the mucosa using the pre-processor filter called Optical enhancement (Pentax Video Processor EPK-i7010; HOYA Co. Tokyo, Japan)
16042978|NCT02575287|Device|Optical Enhancement with optical magnification|A endoscopic visualization of the mucosa using the pre-processor filter called Optical enhancement associated with an optical magnification using the scope called magniview (PENTAX Medical EG-2990Zi)
16042979|NCT02575287|Device|Optical magnification without Optical enhancement|A endoscopic visualization of the mucosa using optical magnification without the use of the pre-processor filter called Optical enhancement
16042980|NCT02575274|Procedure|Surgical flaps|Surgical intervention will be performed with full thickness mucoperiostal flaps to obtain access in the bone defects. All groups will receive the same treatment for implant surface decontamination: debridement with plastic curette Implacare Hu-Friedy®, cleaning the surface with chlorhexidine gel 2% during 3 minutes and abundant irrigation with saline solution 0.9%.
16042981|NCT02575261|Biological|CAR-T cell immunotherapy|This CAR-T cell immunotherapy with a novel specific Chimeric antigen receptor aiming at EphA2 antigen.
16042982|NCT02575248|Drug|Dienogest 2mg|Dienogest 2mg is given daily for 3 months then followed by Clomiphene citrate 5 mg induction of ovulation for three months
16042983|NCT02575248|Drug|Clomiphene citrate 5 mg|Clomiphene citrate 5 mg for induction of ovulation for three months
16042984|NCT02575235|Drug|Cetylpyridinium Chloride (CPC)|Two study groups take CPC of 1.5mg and 4.5mg daily for four weeks.
16042985|NCT02575235|Drug|placebo|Control group takes the placebo for the same period.
16042986|NCT02575222|Drug|Nivolumab|3 mg/kg, IV (in the vein) on day 1 of each 2-week cycle, for a total of 3 doses prior to nephrectomy.
16042987|NCT02575209|Other|GENDER|
16042988|NCT02575196|Device|Non-invasive cerebral flow monitoring|As soon as possible after ROSC, c-flow monitor will be connected to the patient, recording cerebral flow index for the first 72 hours following ROSC. All other relevant clinical data will be recorded.
16042989|NCT02575183|Drug|Varinecline (Chantix)|A randomized double-blind placebo-controlled trial that will evaluate the effect of Varenicline (Chantix), in 2 parallel groups of habitual waterpipe smokers who are willing to quit (n=152). 76 subjects will be randomized to receive varenicline (Chantix). The participants, study investigators and personnel who will be interviewing the participants and collecting the clinical data, will be blinded to the assigned treatment.
16042990|NCT02575183|Drug|Placebo (for Varenicline)|A randomized double-blind placebo-controlled trial that will evaluate the effect of Varenicline (Chantix), in 2 parallel groups of habitual waterpipe smokers who are willing to quit (n=152). 76 subjects will be randomized to receive a varenicline-matched. The participants, study investigators and personnel who will be interviewing the participants and collecting the clinical data, will be blinded to the assigned treatment.
16042991|NCT02575183|Behavioral|Behavioral Therapy|This intervention is for all study participants and it involves 4 visits to the hospital. Each visit include a 30-min one-on-one individual session with the specialized therapist during which participants will be taught how to manage any withdrawal symptoms they experience, how to anticipate high-risk situations, deal with smoking triggers, achieve and maintain their goal to stop waterpipe smoking.
16042992|NCT02575170|Drug|Amino acid solution|a balanced mixture of 18 pure crystalline amino acids, eight of which are essential amino acids
16042993|NCT02575170|Drug|Ringer's lactate solution|200 ml of Ringer's lactate solution
16042994|NCT02575157|Other|No intervention|No intervention
16042995|NCT02575144|Drug|Clarithromycin|500mg PO twice daily on days 1-28 for a 28-day cycle
16042996|NCT02575144|Drug|Lenalidomide|25mg PO daily on days 1-21 of a 28-day cycle for patients with a calculated creatinine clearance of >60 cc/min
16042997|NCT02575144|Drug|Dexamethasone|40mg PO will be given on days 1, 8, 15, 22 of a 28-day cycle
16042998|NCT02575131|Other|whole wheat bread yeast basis|
16042999|NCT02575131|Other|Oatmeal|
16043000|NCT02575131|Other|Cheerios|
16043001|NCT02575131|Other|whole wheat sourdough bread|
16043002|NCT02575131|Other|standard breakfast|
16043003|NCT02575118|Device|Restoration of dental caries with dental composite|
16043004|NCT02575092|Drug|Enalapril Maleate Tablets(as the program-based antihypertension)|
16043005|NCT02575092|Drug|Enalapril Maleate and Folic Acid tablets(as the program-based antihypertension)|
16043006|NCT02575092|Drug|Placebo|
16043007|NCT02575079|Device|Parafilm|Single-use, pre-cut sections of parafilm over the central venous catheter (CVC) hub (if not connected) or around the CVC hub connection (if connected). Parafilm will be maintained on the CVC until it is removed.
16043008|NCT02575066|Radiation|external beam radiotherapy|external beam radiotherapy 25 x 2 Gy / 18 x 2 Gy
16043009|NCT02575066|Drug|pazopanib|pazopanib QD 800 mg
16043010|NCT02575053|Procedure|assessment of a new latex protocol|"All powdered latex surgical gloves are removed from the operating theatres, recovery room and surroundings starting from 01-07-2015 in order to create a latex safe environment.
~Steps 2 and 3 remain unchanged in respect to ASA( American Society of Anesthesiologists) protocol.
~Removal of all materials containing latex from the resuscitation carts.
~Further requirements in case of latex allergic patients:
~Identification of patients with (suspected) latex allergy.
~All materials used during the procedure (catheters, drains, monitoring equipment,…) should be checked for latex.
~All latex containing materials should be removed from the room and latex free alternatives should be available.
~All staff present in the room should use latex free synthetic gloves.
~Operating tables and supports should be made of latex free material or should be covered with blankets.
~The entire OR staff is thoroughly educated concerning the latex safe protocol."
16043011|NCT02575040|Biological|Fecal microbiota transplantation|Fecal microbiota transplantation to patients with ulcerative colitis and Crohn disease
16043012|NCT02575027|Radiation|Palliative Radiation Therapy|Undergo 4pi palliative radiotherapy
16043013|NCT02575027|Other|Questionnaire Administration|Ancillary studies
16043015|NCT02575014|Drug|Preoperative hyperbaric oxygen|Subjects undergoing preoperative HBOT will be treated with up to 2.4 ATA O2, for a maximum of 90 minutes each day with or without air breaks, as deemed necessary by the investigator, for two days. The two days will be the day of and the day immediately prior to the operation.
16043016|NCT02575001|Behavioral|Psychological background determinations|"For the psychological background determinations a structured interview and questionnaires will be administered:
~Child Attachment Interview (CAI)
~General/sociodemographic questionnaire with the questions on diabetes management, current health status and the child's development in the infancy
~Parenting Stress Index with the 19-item Life Stress Scale (PSI)
~Achenbach System of Empirically Based Assessment (CBCL, YSR)
~Holmes and Rahe Social readjustment rating scale
~Lifetime Incidence of Traumatic Events (LITE) - parent and child reports of child's trauma/loss history (LITE- S/ P)
~Experiences in Close Relationships - Relationship Structures questionnaire (ECR-RS)"
16043017|NCT02575001|Genetic|Genetic susceptibility determination|DNA will be isolated from the patients' blood samples and form the control subjects buccal swabs. The genes with expected influence to stress reactivity and mental disorders will be tested.
16043018|NCT02575001|Procedure|Cortisol release test|Synacthen test - will be used with the group of patients with type 1 diabetes to measure HPA axis reactivity
16043019|NCT02575001|Procedure|Saliva cortisol measurement|Saliva cortisol measurement - will be used with the patients before and after the Synacthen test and with the Hashimoto thyroiditis and the healthy control group before and after the Child Attachment Interview
16043020|NCT02574975|Drug|methacholine|Methacholine,inhaled cumulative dosage 2.5mg
16043021|NCT02574975|Drug|adenosine monophosphate|Adenosine monophosphate ,inhaled cumulative dosage 40mg
16043022|NCT02574975|Drug|leukotriene D4|Leukotriene D4,inhaled cumulative dosage 2.4 μg
16043023|NCT02574975|Device|Astograph Jupiter-21 airway reaction testing apparatus|Methacholine bronchial provocation test was performed by using Astograph Jupiter-21 airway reaction testing apparatus
16043024|NCT02574975|Drug|budesonide /formoterol|budesonide 160μg and formoterol 4.5ug,1 inhalation ,twice daily ,for three months in all participants (80 Anticipated)
16043025|NCT02574962|Drug|H.P. Acthar® Gel|
16043026|NCT02574949|Radiation|Radiation: 15 FPS Cine 15 PPS|Radiation 15 FPS Cine 15 PPS
16043027|NCT02574949|Radiation|Radiation: 7.5 low Frame rate|Radiation: Frame rate 7.5 FPS, Cine 15 PPS
16043028|NCT02574949|Radiation|Low Cine|Radiation: Frame rate 7.5 FPS, Cine 10 PPS
16043029|NCT02574936|Procedure|A new surgical technique|"Description of a new surgical technique in pilonidal sinüs surgery in order to reduce dead space volume.
~A flap extending across the cut (Karydakis) is prepared in medial edge of the wound, 1 cm deep and 2 to 3 cm to be towards the interior. Prepared flap is shifted to the medial and sutured to presacral fascia with vicryl 2/0. To reduce the volume of the dead space formed in the lateral, 5 mm skin is excised along the incision in the flap side. Skin is approximated with sutures in the form of intermittent, using 2/0 poliprolen. No drain used"
16043030|NCT02574923|Biological|Autologous Bone Marrow Mononuclear Cells|Transplantation of Autologous Bone Marrow Mononuclear Cells
16043031|NCT02574910|Drug|Abiraterone acetate|This is a dose escalation study. Up to 3 successive cohorts of 8 subjects each will receive 7 days of 1, 2 or 4 mg/kg/d of abiraterone acetate, until 7/8 subjects have met the desired endpoint.
16043032|NCT02574897|Other|Electronic symptom survey|Standard of care plus daily electronic symptom surveys, the results of which are sent to clinicians electronically.
16043033|NCT02574897|Other|Blinded Electronic Symptom Survey|Standard of care daily clinician interviews with blinded symptom surveys
16043034|NCT02574884|Procedure|Blood sample (act specific of blood withdrawal for the study)|Specific intervention : blood sample (3x7 ml in total)
16043035|NCT02574871|Other|Psychological and biological data collection|Psychological and biological data collection for identification of the chronic stress presence
16043036|NCT02574858|Drug|QRH-882260|The investigational agent to be used in this study is a fluorescently-labeled peptide composed of a 7-amino acid sequence attached to Cy5.
16043037|NCT02574845|Drug|Rosuvastatin|
16043038|NCT02574845|Drug|Metformin HCl|
16043039|NCT02574845|Drug|Furosemide|
16043040|NCT02574832|Drug|Lidocaine Administration|The lidocaine dose will be determined using a 9:1 biased-coin sequential allocation method. For the first participant, the starting dose will be 32 mg of 2% isobaric lidocaine (1.6 mL). Two outcomes will be possible: satisfactory or unsatisfactory anesthesia.
16043041|NCT02574819|Drug|Methylnaltrexone (MNTX)|MNTX nearly 0.15mg/kg administered every other day for 2 weeks. Baseline laxatives and rescue laxative ( enemas/suppositories ) were allowed, but could not be administered within 4 hours of the study drug.
16043042|NCT02574819|Drug|Placebo|Placebo administered every other day for 2 weeks. Baseline laxatives and rescue laxative ( enemas/suppositories ) were allowed, but could not be administered within 4 hours of the study drug.
16043043|NCT02574806|Procedure|Blood sample and BNP measurement|Blood sample of umbilical artery from umbilical cord immediately after birth.
16043044|NCT02574793|Device|continuous glucose monitoring|Patients newly diagnosed GH-releasing pituitary adenoma or Cushing Syndrome in our department will be monitored blood glucose by CGMS Gold.
16043045|NCT02574780|Other|complex physical therapy|Compare the standard treatment of lymphedema, by complex physical therapy versus TFC associated with the upper limbs strengthening exercises.
16043046|NCT02574780|Other|Evaluate treatment of lymphedema, with in the quality of life and depression|evaluate through the questionnaires fatigue and quality of life of patients with lymphedema (FACT- F and Inventory BECK)
16043047|NCT02574767|Behavioral|Lifestyle counseling|Obese pregnant women from PHCC randomized to this group will receive Home-based Diet & Physical activity (PA) counseling. Home-based intervention will consider 2 home visits of one hour of duration. During this session dietary educational and behavioral will be discussed with the participants and their families tailoring the contents based on the specific contexts.
16043048|NCT02574767|Dietary Supplement|PUFA Supplementation|Obese pregnant women from PHCC randomized to this group will receive n3LC-PUFAs oral supplementation based on Schizochytrium oil (S-oil) containing 800 mg docosahexaenoic (DHA) acid/day, which will be administered as capsular preparations containing 200 mg DHA/capsule (4 capsules/day).
16043284|NCT02573233|Drug|budesonide and formoterol|Pharmaceutical form:inhalation aerosol Route of administration: inhaled
16043049|NCT02574767|Behavioral|Routine diet & PA|Obese pregnant women from PHCC randomized to this group will receive will receive routine diet & PA counseling (i.e. they will receive the standard education sessions included in the prenatal controls at PHCC but no home-based counseling sessions).
16043050|NCT02574767|Dietary Supplement|PUFA placebo|Obese pregnant women from PHCC randomized to this group will receive capsular preparations containing 50 mg DHA/capsule (4 capsules/day), given that evidence suggests that it would be unethical not to provide DHA during pregnancy. Placebo will be delivered in the same way that the n3LC-PUFA supplementation.
16043051|NCT02574754|Drug|warfarin|warfarin 10 mg PO x 1
16043052|NCT02574741|Behavioral|Behavioral Therapy|Thrice-weekly individually based language JAE-EMT intervention will be provided by a trained therapist and taught to the child and their caregivers. A total of 36 sessions will be provided over 12 weeks, with 2 per week at UCLA, and one session per week in the home.
16043053|NCT02574741|Drug|Aripiprazole|50% of the subjects will be randomized to aripiprazole (active study medication)
16043054|NCT02574741|Drug|Placebo|50% of the subjects will be randomized to placebo (inactive study medication).
16043055|NCT02574728|Drug|Sirolimus|The starting dose for sirolimus is 2 mg/m2 once daily. The dose of sirolimus will be individually adjusted to achieve a target serum trough concentration in the range of 10-15 ng/ml. Sirolimus will be given by mouth every day for six weeks (every six weeks is called one cycle) for up to two years or 16 cycles.
16043056|NCT02574728|Drug|Celecoxib|Celecoxib 100 mg will be given by mouth twice a day for six weeks (every six weeks is called one cycle) for up to two years or 16 cycles.
16043057|NCT02574728|Drug|Etoposide|Etoposide 50 mg/m2 (maximum dose 100 mg) will be given daily by mouth for the first 3 weeks of a 6 week cycle. Six week cycles will be repeated for up to two years or 16 cycles.
16043058|NCT02574728|Drug|Cyclophosphamide|Cyclophosphamide 2.5 mg/Kg (maximum dose 100 mg) will be given daily by mouth for the second 3 weeks of a 6 week cycle. Six week cycles will be repeated for up to two years or 16 cycles.
16043059|NCT02574715|Drug|Levonorgestrel (Jaydess, BAY86-5028)|Intrauterine delivery system Jaydess (13.5 mg levonorgestrel)
16043060|NCT02574702|Procedure|application of a contralateral drainage (Penrose ® device)|application of a contralateral drainage (Penrose ®) in surgical wound of primary loop ileostomy closure
16043061|NCT02574689|Behavioral|HIPP|The physical activity intervention is based on the Social Cognitive Theory and Transtheoretical Model and includes motivation-matched physical activity manuals and individually-tailored computer expert system feedback reports. Tailored reports are based on participants' monthly update survey data and cover: 1) current stage of change; 2) self-efficacy; 3) decisional balance; 4) social support; 5) outcome expectations; 6) enjoyment; 7) progress feedback; 8) normative feedback; 9) self regulation. The computer expert system draws from a bank of 330 messages addressing different levels of psychosocial and environmental factors affecting physical activity.
16043062|NCT02574689|Behavioral|Wellness contact control|"Cancer prevention information on topics other than physical activity (e.g., Add Fruits and Veggies to Your Diet) from the American Cancer Society website (www.cancer.org) are mailed to control participants at the same time points that the HIPP Intervention participants receive their physical activity intervention materials."
16043063|NCT02574676|Other|non-interventional|
16043064|NCT02574663|Drug|TGR-1202|TGR-1202 oral daily dose
16043065|NCT02574663|Drug|nab-paclitaxel + gemcitabine|IV infusion
16043066|NCT02574663|Drug|Oxaliplatin + Folinic acid + Fluorouracil|IV infusion
16043067|NCT02574663|Drug|Oxaliplatin + Folinic acid + Fluorouracil + Bevacizumab|IV Infusion
16043068|NCT02574650|Device|Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS)|Mitralign Percutaneous Tricuspid Valve Annuloplasty System (PTVAS) delivered by a percutaneous transcatheter procedure.
16043069|NCT02574637|Drug|Brazikumab IV Infusion|Brazikumab IV infusion as per protocol specified dosing schedule.
16043070|NCT02574637|Drug|Brazikumab SC Injection|Brazikumab IV infusion as per protocol specified dosing schedule.
16043071|NCT02574637|Drug|Placebo|Placebo-matching Brazikumab IV infusion as per protocol specified dosing schedule.
16043072|NCT02574624|Procedure|Intraocular assistance|Intraocular assistance with help of surgical assistants during vitreous surgery (VISIA) in patients who require vitreous surgeries as part of standard of care procedure for conditions like retinal detachments, dislocated intraocular lens and glaucoma patients requiring endophotocoagulation.
16043073|NCT02574611|Drug|Neostigmine|
16043074|NCT02574611|Drug|Glycopyrrolate|
16043075|NCT02574611|Other|Saline (Placebo)|
16043076|NCT02574611|Device|High Resolution Colonic Manometry|
16043077|NCT02574598|Drug|MK-3475|The dosing interval of pembrolizumab can be increased in case of toxicity.
16043078|NCT02574598|Drug|Docetaxel|Use on both arms as standard of care.
16043079|NCT02574585|Biological|Autologous mesenchymal cells transplantation|Two percutaneous injections of mesenchymal stem cells, with a 3-month interval between the injections.
16043080|NCT02574572|Biological|Autologous mesenchymal cells transplantation|All patients will undergo laminectomy and autologous mesenchymal cells injection into the lesion area.
16043081|NCT02574559|Behavioral|Cognitive Based Compassion Training Session: Developing Attention and Stability of Mind|Completed at Week 1. Initial meditation exercises will be described and practiced to train attention skills (on breath) and create mental stability.
16043082|NCT02574559|Behavioral|Cognitive Based Compassion Training Session: Cultivating Insight into the Nature of Mental Experience|Completed at Week 2. Exercises to develop mindfulness will continue in order to promote mental stability and clarity.
16043083|NCT02574559|Behavioral|Cognitive Based Compassion Training Session: Self-compassion|Completed at Week 3: Techniques to analyze mental processes are introduced.
16043084|NCT02574559|Behavioral|Cognitive Based Compassion Training Session: Cultivating Equanimity|Completed at Week 4. Further analysis of mental processes.
16043085|NCT02574559|Behavioral|Cognitive Based Compassion Training Session: Developing Appreciation and Gratitude for Others|Completed at Week 5. A reflection of all the things that bring us well-being are provided by or dependent upon other beings is encouraged.
16043127|NCT02574273|Behavioral|Secret Agent Society (SAS) Program|The Secret Agent Society (SAS) intervention involves subjects participating in 9 weekly two-hour therapy groups ('Club meetings') with 3 to 6 other children. The SAS intervention includes a number of components to help children apply the skills that they learn in the session to home.
16043086|NCT02574559|Behavioral|Cognitive Based Compassion Training Session: Developing Affection and Empathy|Completed at Week 6. The following concepts are presented and carefully considered: (1) cooperation and solidarity is essential for our survival and flourishing, as we are all extremely vulnerable and need each other; (2) hate and selfishness only cause suffering to others and ourselves and can only be prevented by cultivating sincere affection for others.
16043087|NCT02574559|Behavioral|Cognitive Based Compassion Training Session: Realizing Wishing and Aspiring Compassion|Completed at Week 7. Participants are invited to deepen their reflection on the reasons for gratitude, empathy, and affection for others, and see how they lead to feelings of compassion, or the wish for others to be free from suffering.
16043088|NCT02574559|Behavioral|Cognitive Based Compassion Training Session: Realizing Active Compassion|Completed at Week 8. The strategies used until this point will be reviewed in order to move from the wish for others to be free of suffering, toward the sense that we want to and must take steps to relieve their suffering.
16043089|NCT02574559|Behavioral|Meditation Session|20 minute session completed weekly after the Cognitive Training Session
16043090|NCT02574546|Procedure|Mastectomy|Unilateral breast cancers planning bilateral mastectomy procedures.
16043091|NCT02574533|Biological|Vigil|Vigil™ 1 x 10e7 cells via intradermal injection on Day 1, 15, 29, 43 and then every 3 weeks thereafter for a minimum of 4 administrations and a maximum of 9 administrations (depending on the quantity of Vigil™ manufactured from surgical specimens)
16043092|NCT02574533|Drug|Pembrolizumab|Pembrolizumab 2mg/kg by intravenous infusion over 30 minute starting on day 43 and every 3 weeks thereafter
16043093|NCT02574520|Drug|SABER-Bupivacaine (Part 1)|5 ml once at end of surgery
16043094|NCT02574520|Drug|SABER-Bupivacaine (Part 2)|5 ml once at end of surgery
16043095|NCT02574520|Drug|Saline Placebo|5 ml once at end of surgery
16043096|NCT02574520|Drug|Bupivacaine HCl|0.5%, 15 ml, once at end of surgery
16043097|NCT02574507|Behavioral|Couples-Based Behavioral Weight and Symptom Management|Investigators anticipate that the intervention developed in phase I will consist of a total of 12 sessions 90 minutes in length (18 therapy hours) spaced across approximately 5 months. Sessions are spaced to provide participants sufficient time to complete home practice exercises and adequately examine change in weight and maintenance of weight loss. Sessions will be conducted individually for each day. The first 6 sessions will occur weekly and the final 6 sessions will occur biweekly.
16043100|NCT02574468|Drug|Dexamethasone applied on pulp or Dexamethasone did not applied on pulp|on half of cases we put dexamethasone on pulp on other half we did not put dexamethasone on pulp
16043101|NCT02574468|Procedure|DPC or MP|on half of cases we treat teeth with DPC(Direct Pulp Cap) on other half we treat teeth with MP(Miniature Pulpotomy)
16043102|NCT02574455|Drug|Sacituzumab govitecan|10 mg/kg administered as a slow intravenous (IV) infusion either by gravity or with an infusion pump. Infusion rate for the first 15 minutes will start with 50 mg/hour or less with a subsequent infusion of 100 to 200 mg/hour up to a maximum recommended rate (advanced every 15 to 30 minutes) of 500 mg/hour with a subsequent infusion of 1000 mg/hour.
16043103|NCT02574455|Drug|Eribulin|Administered IV over 2 to 5 minutes at a dose 1.4 mg/m^2 at North American sites and 1.23 mg/m^2 at European sites on Days 1 and 8 of a 21-day cycle. Lower doses will be administered on the same schedule to participants with moderate hepatic impairment (ie, Child-Pugh B; 0.7 mg/m^2 and 0.67 mg/m^2 for North American and European sites, respectively).
16043104|NCT02574455|Drug|Capecitabine|1000 to 1250 mg/m^2 will be administered in a 21-day cycle, with capecitabine administered orally twice daily for 2 weeks followed by 1-week rest period.
16043105|NCT02574455|Drug|Gemcitabine|800 to 1200 mg/m^2 will be administered IV over 30 minutes on Days 1, 8, and 15 of a 28-day cycle.
16043106|NCT02574455|Drug|Vinorelbine|25 mg/m^2 will be administered as a weekly IV injection over 6-10 minutes. Vinorelbine will not be allowed as TPC for any participant with Grade 2 neuropathy.
16043107|NCT02574442|Device|In Vivo Confocal Microscopy Probe|Participants will have 2 areas on their cervical imaged by the confocal probe.
16043108|NCT02574429|Behavioral|Cognitive Processing Therapy|Cognitive Processing Therapy is an evidenced-based treatment for PTSD. The investigators are offering CPT group over 13 weeks (12 group sessions & 1 individual session). CPT focuses on challenging beliefs that developed or were reinforced following the trauma(s).
16043109|NCT02574416|Other|There is no intervention|The study is observational and there is no intervention
16043110|NCT02574403|Drug|eculizumab|eculizumab discontinuation
16043111|NCT02574377|Drug|A: myDC vaccination|
16043112|NCT02574377|Drug|B: pDC vaccination|
16043113|NCT02574377|Drug|C: combined myDC/pDC vaccination|
16043114|NCT02574364|Radiation|The application of abdomen CT|A modified incision(MI)was designed based on abdomen CT.Using a MI compare traditional incision(TI) to the patient including cut extended, operating time,cut infection, false-positive rate,rehabilitation and return to work.
16043115|NCT02574364|Other|traditional incision|McBurney incision,Rectus incision,Appendix Transverse incision or Tenderness point incision,it was invaginated at the discretion of the surgeon.
16043116|NCT02574351|Biological|blood draw, breathing test|A blood draw,breathing test will be performed on every participant
16043117|NCT02574338|Device|Foley's Catheter|intracervical extraamniotic Foley's catheter
16043118|NCT02574338|Drug|prostaglandin E1 analogue|intravaginal misoprostol
16043119|NCT02574325|Drug|Placebo|Control
16043120|NCT02574325|Drug|ARI-3037MO|Treatment
16043121|NCT02574312|Device|ATTUNE TKA with ATTUNE RUI|ATTUNE TKA with ATTUNE RUI
16043122|NCT02574312|Device|ATTUNE TKA with ATTUNE SUI|ATTUNE TKA with ATTUNE SUI
16043123|NCT02574299|Other|E-learning|Management of auditory processing disorders with serious game (E-learning)
16043124|NCT02574299|Device|Hearing aids fitting|Symmetrical hearing loss which are fitted with binaural hearing aids for the first time
16043125|NCT02574286|Drug|Velaglucerase alfa|Participants will receive 60-minute intravenous infusion of 60 U/kg velaglucerase alfa EOW.
16043126|NCT02574286|Dietary Supplement|Vitamin D|Participants will receive 800 IU vitamin D orally daily.
16043128|NCT02574273|Other|Waitlist Group / Treatment As Usual|The wait list control condition includes the treatment participants are already receiving (which may include but is not limited to: individual therapy, group therapy, and/or medication management). Therefore, the wait list control condition consists of treatment which is individually tailored for each participant. Parent and child assessments will be completed at pre and post treatment (Wk 1 and Wk 10) and at 3-month and 6-month follow-up booster visits. The wait-list group will then be given the opportunity to participate in the SAS intervention at their treating clinic.
16043129|NCT02574260|Biological|Talimogene Laherparepvec|Administered by intratumoral injection.
16043130|NCT02574247|Procedure|Computerized auditory training|10 sessions of computerized auditory training (1.5 hr/session) across a 15-week span.
16043131|NCT02574234|Other|Determination of apelin and inflammatory cytokines|A blood sample will be conducted at baseline, on day 1 and day 7 post operative to meter inflammatory cytokines (IL1B, IL1-ra, IL6) and apelin.
16043132|NCT02574234|Other|Assessment of cognitive functions|Evaluation of preoperative cognitive performance by achieving a IQCODE, an MMS and an IADL scale.
16043133|NCT02574234|Other|Liquid sampling cerebrospinal|Determination of the concentrations of inflammatory cytokines and apelin in cerebrospinal fluid perioperatively.
16043134|NCT02574234|Other|Postoperative delirium research|Using the scale Confusion Assessment Method (CAM) for screening and delirium diagnosis. This research will be daily lasted, during the first 7 days postoperative.
16043135|NCT02574234|Other|Residual cognitive dysfunction research|Evaluation of postoperative cognitive performance by achieving a IQCODE, an MMS and an IADL scale realised on day 1 and day 7 postoperative. Realization of the IQCODE and IADL three months after the operation in a telephone interview.
16043136|NCT02574221|Drug|stannous fluoride toothpaste|0.454% stannous fluoride toothpaste
16043137|NCT02574221|Drug|cavity protection toothpaste|0.243% sodium fluoride toothpaste
16043138|NCT02574208|Procedure|HIV testing by ELISA|HIV testing randomized between ELISA or rapid test
16043139|NCT02574208|Procedure|HIV testing by rapid test|HIV testing randomized between ELISA or rapid test
16043140|NCT02574182|Radiation|Brain MRI|"Brain MRI (Magnetic Resonance Imaging) brain is a painless test that allows to visualize the different brain structures.
~Korvit, device made up of 2 shoes which reproduces the feeling to go. The Korvit® system appears possible to analyze the activated cerebral zones and to thus try to better understand the operation of the brain during walk.
~The GAITRite is a carpet for recording the walking operating parameters"
16043141|NCT02574169|Other|alveolar recruitment maneuvers group 1|"Patients are randomized to receive in cross-over 2 ARM: CPAP at first and then eSigh.
~The continuous positive airway pressure, or CPAP with application of a positive pressure of 40 cmH2O for 40 seconds without tidal volume.
~The eSigh or extended sigh with increase of PEEP for 10 minutes to maintain plateau pressure at 40 cmH2O. During ARM, the peak pressure is limited to 50 cmH2O with decrease of tidal volume (Vt) if necessary.
~The following data: PtiO2, respiratory parameters, systemic and intracerebral hemodynamic parameters are collected before, after 1 minute, 10 minutes and 60 minutes for each ARM."
16043142|NCT02574169|Other|alveolar recruitment maneuvers group 2|"Patients are randomized to receive in cross-over 2 ARM: eSigh at first and then CPAP.
~The eSigh or extended sigh with increase of PEEP for 10 minutes to maintain plateau pressure at 40 cmH2O. During ARM, the peak pressure is limited to 50 cmH2O with decrease of tidal volume (Vt) if necessary.
~The continuous positive airway pressure, or CPAP with application of a positive pressure of 40 cmH2O for 40 seconds without tidal volume.
~The following data: PtiO2, respiratory parameters, systemic and intracerebral hemodynamic parameters are collected before, after 1 minute, 10 minutes and 60 minutes for each ARM."
16043143|NCT02574156|Drug|Insulin|All patients will receive insulin. However, the infusion flow will be different according to the group.
16043144|NCT02574130|Drug|Amikacin|400 mg, nebulizer, every 12 hours, 10 days
16043145|NCT02574130|Drug|Placebo|placebo 4 ml, nebulizer, every 12 hours, 10 days
16043146|NCT02574117|Procedure|flap with corticotomy and bone allograft|A maxillary expansion with quad helix appliance was placed on the posterior teeth with cross bite. A Luebke buccal flap was opened in the area of maxillary 1st premolar, 2nd premolar and first molar with a no. 15 scalpel. Corticotomy procedure was performed using low speed round bur size 3, holes to create a 0.5 mm deep hole penetrating the cortical bone. Multiple holes were performed leaving 1.5 mm distance in between. The defects were covered with demineralized freeze-dried bone allograft and the flap was sutured in its original position with 3-0 black silk suture.
16043147|NCT02574104|Other|Simulate a functional NICU prior to moving patients|Test translation of care paradigms in the new environment a priori. Invest significant time and resources into scenario design, staffing, preparing and orchestration the simulations. 80-160 staff participate in simulations, discover and resolve latent safety threats
16043148|NCT02574091|Drug|1% icotinib hydrochloride cream|Topical administration for twice daily
16043149|NCT02574091|Drug|2% icotinib hydrochloride cream|Topical administration for twice daily.
16043150|NCT02574091|Drug|Placebo|Topical administration for twice daily.
16043151|NCT02574078|Drug|Nivolumab|
16043152|NCT02574078|Drug|Bevacizumab|
16043153|NCT02574078|Drug|Pemetrexed|
16043154|NCT02574078|Other|Best Supportive Care|Palliative radiation, palliative surgery and/or other best supportive care treatments
16043155|NCT02574078|Drug|nab-Paclitaxel|
16043156|NCT02574078|Drug|Paclitaxel|
16043157|NCT02574078|Drug|Docetaxel|
16043158|NCT02574078|Drug|Gemcitabine|
16043159|NCT02574078|Drug|Erlotinib|
16043160|NCT02574078|Drug|Crizotinib|
16043161|NCT02574078|Drug|Carboplatin|
16043162|NCT02574065|Drug|L. reuteri DSM 17938|Effects on crying time in colicky infants with the supplementation of Lactobacillus reuteri DSM 17938
16043163|NCT02574065|Other|The placebo consists of an identical formulation without L. reuteri DSM 17938|
16043164|NCT02574052|Behavioral|participants' food choices|just recorded the participants' food choices in the school cafeteria
16043165|NCT02574052|Behavioral|menu labelling without nutrition education|The investigators provided every participant with a menu labeling without any interpretation and recorded their dietary selections
16043209|NCT02573753|Dietary Supplement|Weight gain|
16043210|NCT02573740|Drug|ABT-957|
16043211|NCT02573740|Other|Placebo|
16043212|NCT02573727|Drug|Nor adrenaline + albumin|
16043166|NCT02574052|Behavioral|menu labelling with nutrition education|The investigators not only sent a menu labeling to every participant, but also delivered nutrition education to participants by providing them with nutrition and health knowledge through WeChat daily.
16043167|NCT02574039|Dietary Supplement|Oat bran|66g oat bran made up in 350ml skimmed milk
16043168|NCT02574039|Dietary Supplement|refined grain|refined grain product and 350ml skimmed milk
16043169|NCT02574026|Behavioral|Psychomotor tasks|the acquisition of data will be performed in one unique session no drug administration no surgery
16043170|NCT02574013|Device|Endoractor®|Endoscopic sponge for retraction of small intestine
16043171|NCT02574000|Other|ShoulderQ which is a shoulder pain questionnaire|Questions regarding shoulder pain at rest, during movement and at night with visual analogue scales. Factors affecting shoulder pain.
16043172|NCT02574000|Other|Clinical shoulder examination|Shoulder-Hand-Score (measuring pain, oedema, passive range of movement), muscle strength (using Oxford scale and National Institute of Health Stroke Scale (NIHSS) upper limbe motor and shoulder joint palpation (recording subluxation and soft-tissue pain).
16043173|NCT02573987|Drug|Oxygen/nitrous oxide equimolar mix|an experimental strategy inhalation by means of a breathing mask diffusing MEOPA
16043174|NCT02573987|Drug|Lidocaine|standard strategy by local injection anesthesia of lidocaine
16043175|NCT02573974|Other|Samples|Blood samples, muscle biopsy and sample of hair
16043176|NCT02573961|Device|Laser acupuncture|GaAlAs semiconductor diode Laser Phototherapy Device
16043177|NCT02573961|Behavioral|high protein low carbohydrate diet|A tailored high protein/low carbohydrate/low caloric diet
16043178|NCT02573961|Behavioral|low caloric diet|Tailored balanced low caloric diet
16043179|NCT02573948|Other|no intervention is assessed|
16043180|NCT02573935|Drug|Clarithromycin|p.o. clarithromycin 500 mg twice daily for 63 days
16043181|NCT02573935|Drug|Placebo|Placebo tablet twice daily for 63 days
16043182|NCT02573935|Drug|VCD induction therapy|Three courses of VCD (sc bortezomib 1.3 mg/sqm days 1, 4, 8, 11, iv cyclophosphamide 500 mg/sqm on days 1 and 8, and p.o. dexamethasone 40 mg days 1, 2, 4, 5, 8, 9, 11, 12 in each 21-days course)
16043183|NCT02573922|Drug|oxycodone-naloxone|
16043184|NCT02573922|Drug|Oxycodone|
16043185|NCT02573909|Drug|Oxycodone intravenously|Oxycodone intravenously 0,1mg/kg
16043186|NCT02573909|Drug|Oxycodone epidurally|Oxycodone 0,1 mg epidurally
16043187|NCT02573896|Drug|Ch14.18|17.5 mg/m2/day of Ch.14.18 will be given for 4 consecutive days (days 1-4 of each course) via intravenous infusion over ten hours.
16043188|NCT02573896|Biological|NK Cells|The designated dose of NK Cells will be infused on Day 5 by IV drip using a Y infusion set with a filter-less chamber. Cells should not be delivered at a rate faster than 10 ml/kg/hr (as determined by drip rate or syringe push rate), and should not take longer than one hour for total infusion time if possible.
16043189|NCT02573896|Drug|Lenalidomide|25 mg/m2/day of Lenalidomide will be given at Dose Level 4, once daily with or without food by mouth on days -6 through +14.
16043190|NCT02573883|Device|Fractionated Carbon Dioxide Laser|Vulvar lichen sclerosis will be treated except for the clitoris glans and clitoral hood which will be spared with at least 5mm margin. The procedure will be performed in the outpatient clinic at the National Center for Advanced Pelvic Surgery at MedStar Washington Hospital Center Lafayette Office, 1133 21st St NW, Washington, DC 20036, and include 3 sessions, 4 weeks apart.
16043191|NCT02573883|Drug|Clobetasol Propionate 0.05% ointment|Topical Steroid therapy (Clobetasol propionate .05% ointment nightly for one month then three times weekly for 2 additional months) for a total of three months of treatment.
16043192|NCT02573870|Drug|Batefenterol + Fluticasone Furoate|Batefenterol and Fluticasone Furoate (FF) will be provided as a fixed-dose combination in a dry powder inhaler (DPI), for oral inhalation once every morning, for 42 days. The DPI will consist of 2 strips of 30 blisters each, containing 300 microgram (mcg) batefenterol per blister in one strip and 100 mcg FF per blister in another strip. Both drugs will be available in a micronized form, blended with lactose monohydrate.
16043193|NCT02573870|Drug|Placebo|Placebo will be provided in a DPI, for oral inhalation once every morning, for 42 days. The DPI will consist of 2 matching strips of 30 blisters each, with each blister containing lactose monohydrate and no active pharmaceutical ingredient.
16043194|NCT02573870|Drug|Albuterol|Albuterol inhalation will be provided as an open-label rescue medication to use as needed, to relieve chronic obstructive pulmonary disease (COPD) symptoms.
16043195|NCT02573857|Drug|DSM265|Oral suspension from bulk powder
16043196|NCT02573857|Drug|OZ439|Oral suspension from powder in a bottle
16043197|NCT02573844|Drug|Proklama|
16043198|NCT02573844|Drug|Placebo|
16043199|NCT02573831|Drug|Oxycodone|The patients are given at first oxycodone 0,05 mg/kg and after one hour oxycodone 0,05 mg/kg if their pain in numerical rating scale from 0 to 10 is 5 or more
16043200|NCT02573831|Drug|Placebo|The patients are given at first placebo and after one hour oxycodone 0,05 mg/kg if their pain in numerical rating scale from 0 to 10 is 5 or more
16043201|NCT02573818|Device|SEDASYS System|propofol sedation with the SEDASYS System
16043202|NCT02573805|Device|Rigiscan test|Rigiscan tests are performed in enrolled subjects for consecutive two nights.
16043203|NCT02573779|Other|Observational - no intervention|This study will observe cohorts of infants who are fed primarily either their own mother's milk or donor milk as part of their routine care. No direct intervention is performed as part of the study.
16043204|NCT02573766|Procedure|Neurofeedback Training|Neurofeedback Group + Sham Neurofeedback Group: Participants participate in sessions for a minimum of 2 treatments a week for a maximum of 10 weeks for a total of 20 sessions.
16043205|NCT02573766|Procedure|Electroencephalogram|"Participants undergo an EEG at baseline, during each neurofeedback session, within 7 days of the conclusion of treatment, and again in one month.
~Standard of care group receives EEG at baseline, 1 week after neurofeedback group completes sessions, and again in one month."
16043206|NCT02573766|Behavioral|Pain Scale|Participants in neurofeedback groups asked to rate their pain on a scale of 0 (no pain) to 10 (the worst pain) prior to each session of neurofeedback, and again at the conclusion of the session.
16043207|NCT02573766|Behavioral|Questionnaires|Seven questionnaires regarding symptoms and quality of life completed at baseline, 1 week after neurofeedback sessions, and again in one month.
16043208|NCT02573753|Behavioral|Sleep restriction|
16043214|NCT02573714|Drug|Ketamine|Intranasal ketamine (concentration: 50 mg/ml, dose: 1 mg/kg) will be given at time zero. Intranasal administration will be performed by placing the needleless syringe gently into the nares with the patient sitting upright. Volumes of ≤ 0.75ml will be nasally inhaled in a single nare, while volumes > 0.75ml will be divided between both nares. Patients who are unable to inhale the medication nasally will receive drip administration of the same volume while recumbent on the bed.
16043215|NCT02573714|Drug|Normal Saline|Intranasal normal saline (placebo: volume-matched with intranasal ketamine) will be given at time zero. Intranasal administration will be performed by placing the needleless syringe gently into the nares with the patient sitting upright. Volumes of ≤ 0.75ml will be nasally inhaled in a single nare, while volumes > 0.75ml will be divided between both nares. Patients who are unable to inhale the medication nasally will receive drip administration of the same volume while recumbent on the bed.
16043216|NCT02573714|Other|Standard Pain Therapy|Typical management strategy for pediatric sickle cell disease vasoocclusive crises including acetaminophen/paracetamol, ibuprofen, oral opioids, and injectable opioids depending on pain severity.
16043217|NCT02573714|Other|Pediatric Quality of Life - Sickle Cell Disease Module|Standardized quality of life assessment performed 2-3 weeks post intranasal medication administration to evaluate pain management and severity of symptoms after discharge from the hospital.
16043218|NCT02573714|Other|Faces Pain Scale - Revised|All patients will answer the FPS-R at 0 minutes (immediately prior to receiving intranasal medication), 30 minutes, 60 minutes, and 120 minutes to assess current pain status.
16043219|NCT02573701|Drug|Guideline treatment (Risperidone, administered orally)|"Participants will receive the Guideline Treatment (risperidone, administered orally) plus Behavioral Intervention: psychosocial treatment included psychoeducation social skills healthy life style habits exercise in group"
16043220|NCT02573701|Behavioral|"Psychosocial treatment"|"Participants will receive the Guideline Treatment (risperidone, administered orally) plus Behavioral Intervention: psychosocial treatment included psychoeducation social skills healthy life style habits exercise in group"
16043221|NCT02573701|Drug|Treatment as Usual (any other antipsychotic)|Participants will receive the Treatment as Usual (atypical antipsychotic) plus Behavioral Intervention: psychosocial treatment assigned by clinician.
16043222|NCT02573688|Behavioral|Interdisciplinary Therapy|The nutrition intervention will consist of group meetings and prescription of individual diets. Participants will have dietary lessons, with information related to the improvement of food consumption and nutritional quality. Exercise program will be focused on improving activity habits, leading to increased energy expenditure. They will undergo training sessions containing aerobic and resistance training. In Psychological program, participants will be monitored in the support group and, if necessary, individual psychological therapy is recommended. The sessions will discuss common psychological aspects commonly associated with obesity (depression, anxiety, stress, family problems, body image, eating disorders and others). The physiotherapy interventions aim to increase functional capacity.
16043223|NCT02573662|Biological|Blood and Urine sampling|Blood and Urine Sampling
16043224|NCT02573662|Radiation|DXA scan|Scan of Lumbar columna and neck of femur/hip Scan of visceral/subcutaneous fatty tissue
16043225|NCT02573662|Biological|OGTT|Oral Glucose Tolerance Test for Minimal Model analysis for insulin sensitivity and Lipid oxidation
16043226|NCT02573649|Device|Closed-loop Stimulation on first|Closed-loop Stimulation algorithm is turned on in the device. The patient performs a head up tilt test. After a week Closed-loop Stimulation algorithm is turned off and the patient performs a second head up tilt test.
16043227|NCT02573649|Device|Closed-loop Stimulation off first|Closed-loop Stimulation algorithm is turned off in the device. The patient performs a head up tilt test. After a week Closed-loop Stimulation algorithm is turned on and the patient performs a second head up tilt test.
16043228|NCT02573610|Drug|DE-108|Subjects will be assigned to receive DE-108 ophthalmic solution to be administrated one drop a time 3 times daily for 3 days prior and for 14 days following cataract surgery.
16043229|NCT02573610|Drug|Levofloxacin 0.5%|Subjects will be assigned to receive Levofloxacin 0.5% ophthalmic solution to be administrated one drop a time 3 times daily for 3 days prior and for 14 days following cataract surgery.
16043230|NCT02573597|Drug|Bupivacaine|Continuous or bolus administration
16043231|NCT02573597|Drug|Sufentanil|Continuous or bolus administration
16043232|NCT02573571|Other|Development of biomarkers|Blood sampling
16043233|NCT02573558|Drug|Dexmedetomidine|
16043234|NCT02573558|Drug|Propofol|
16043235|NCT02573545|Device|Planning@IFE and Standard@IFE Software|
16043236|NCT02573545|Device|MR Syngo (Numaris/4) software|
16043237|NCT02573519|Radiation|11C Donepezil PET/CT scan|Donepezil binds with high affinity to acetylcholine esterase in the cholinergic synapses. The quantity of density of acetylcholine esterase in the abdominal organs including the intestinal wall are demonstrated by 11C Donepezil PET/CT scan. The PET-signal are measured as Standard-uptake values (SUV) in the internal organs. After 6 hours of fast CT- and PET-scans are performed after injection of iv. contrast and about 500MBq (megabecquerel) [11C]donepezil. The CT scan is used for anatomical location of the internal organs. The scan-field includes the heart and the abdominal organs. Total scan time is about 60 minutes.
16043238|NCT02573519|Device|3D-Transit|"3D-Transit: 3D-Transit for minimal invasive and ambulant describing of regional transit times and contractions pattern of the bowel. The motility and the passage time is measured by 3D-Transit The description of location and rotation of the capsule is dynamic and very precise. It permits precise detailed description of the gastrointestinal contraction pattern and regional passage time. 3D-transit consist of three different parts:
~A wireless electromagnetic capsule to be swallowed by the subject
~A portable detector plate comprising four sensors worn in a belt around the waist
~Specific software for visualizing and analyzing data"
16043239|NCT02573519|Drug|3D-Transit during treatment with Pyridostigmine|3D-Transit and Pyridostigmine: The motility and the passage time is measured by 3D-Transit (as mentioned above) in diabetic patients during administration of Pyridostigmine 60 mg administrated 4 times with 4 hours between each administration. Pyridostigmine is increasing the amount of cholinergic neurotransmitter and is suggested to have a reversible effect on the cholinergic denervation. The mechanism of action of Pyridostigmine in the human body is well-known and the drug is used as a tool to determine if the disturbance in the guts are reversible in diabetic patients.
16043425|NCT02572271|Procedure|LOPOSAM|The surgical technique LOPOSAM is performed. No other intervention.
16043240|NCT02573519|Device|3D-Transit after Malone appendicostomy|3D-Transit (as earlier described) is performed after Malone appendicostomy. The patients are suppose use the antegrade edema technic during the 3D-transit examination.
16043241|NCT02573506|Radiation|split-course radiotherapy|Patients are irradiation at a palliative dose in the initial course: 51Gy/17f to PTV-GTV. The disease is re-evaluated three weeks after the end of the initial course using CT. The patient without disease progression according to the RECIST criteria and had a recovery of lung function should get the additional boost. In the second course, the tumor is repositioned and scanned. The residual tumor is then treated with the second course of radiotherapy. A dose of 15-18 Gy/5-6f is delivered to the residue tumor.
16043242|NCT02573506|Drug|Concurrent chemotherapy|Concurrent chemotherapy consists of weekly docetaxel(25mg/㎡) and nedaplatin(25mg/㎡), each of 1 day's duration.
16043243|NCT02573493|Drug|nab-Paclitaxel|
16043244|NCT02573493|Drug|Cisplatin|
16043245|NCT02573493|Biological|Cetuximab|
16043246|NCT02573493|Radiation|Intensity-Modulated Radiation Therapy|
16043247|NCT02573480|Behavioral|Wraparound care|Wraparound care starts by linking an individual with a support worker who works with them to address risk factors and empower the individual to make positive choices. It not only includes connecting the youth with existing community resources such as education, employment, cultural services and substance counselling, it also helps build problem-solving skills, coping skills, and self-efficacy of the youth and family members. The support worker provides mentorship to the youth. Mentorship both teaches and emulates appropriate behaviours with respect to attitudes and behaviours associated with violence.
16043248|NCT02573467|Drug|Bimagrumab|BYM338, a 150 mg/mL concentrate for solution for i.v. infusion, was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps.
16043249|NCT02573467|Drug|Placebo|Matching placebo to BYM338 was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps.
16043250|NCT02573454|Behavioral|App assignment|Under-active undergraduates are assigned to use a GPS exercise app that is prosocial (i.e., allows the user to raise money for charities) or personal (does not allow the user to raise money for charities) in nature
16043251|NCT02573441|Behavioral|Jump Math|Jump Math is a workbook based program aimed at improving math skills
16043252|NCT02573441|Behavioral|Cogmed|Cogmed is an online computer program aimed at improving working memory skills
16043253|NCT02573441|Behavioral|Liaison Services|Liaison Services will include working closely with schools to help explain the strengths and weaknesses of a child based on cognitive testing and to help with the implementation of recommendations
16043254|NCT02573415|Procedure|Uterus Transplant|transplant of a deceased donor uterus.
16043255|NCT02573402|Device|Transcutaneous Tibial Nerve Stimulation|10 sessions over a 2 week period of TTNS for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode, verified with rhythmic flexion of the toes secondary to stimulation of the flexor digitorum and hallicus brevis. Current intensity may vary from patient to patient and will be documented and used in the analysis.
16043256|NCT02573402|Device|Control|10 sessions over a 2 week period of TTNS sham stimulation for 30 minutes. Electrodes will be placed 2 inch by 4 inch according to anatomic landmarks, with the negative electrode behind the internal malleolus and the positive electrode 10cm superior to the negative electrode. Current intensity will be set to zero.
16043257|NCT02573389|Device|Boston Scientific or Cook pancreatic duct stents|Boston Scientific or Cook straight or pigtail pancreatic stents. Stent size depends on duct size (capacity). Pancreatic plastic stents are made primarily of polyethylene materials. Pancreatic stent sizes range from 2 to 25 cm in length and 3F to 11.5F in.
16043258|NCT02573376|Behavioral|Directly Observed Therapy|
16043259|NCT02573376|Behavioral|Wirelessly Observed Therapy|
16043260|NCT02573363|Drug|Cytarabine|Given per standard of care
16043261|NCT02573363|Drug|Mitoxantrone Hydrochloride|Given per standard of care
16043262|NCT02573363|Drug|Selinexor|Given PO
16043263|NCT02573350|Drug|Delamanid|Delamanid was administered orally as 50-mg tablets.
16043264|NCT02573337|Device|Emervel Classic Lidocaine|Treatment of wrinkles and folds
16043265|NCT02573337|Device|Emervel Deep Lidocaine|Treatment of wrinkles and folds
16043266|NCT02573324|Drug|Temozolomide|Oral Capsule
16043267|NCT02573324|Drug|ABT-414|Intravenous Infusion (IV)
16043268|NCT02573324|Radiation|Radiation|
16043269|NCT02573324|Drug|Placebo for ABT-414|Intravenous Infusion (IV)
16043270|NCT02573311|Drug|tamsulosin hydrochloride|
16043271|NCT02573298|Device|ice|local ice application for 30 minutes
16043272|NCT02573298|Device|cold gas|local cold gas application for 2 minutes
16043273|NCT02573285|Procedure|Simple Aspiration|Aspiration of pneumothorax with a small-bore catheter
16043274|NCT02573285|Procedure|Surgeon Preference|Any standard treatment option may be utilized for the treatment of the pneumothorax, including simple aspiration, chest tube placement, or an operation (VATS).
16043275|NCT02573272|Drug|eslicarbacepine|
16043276|NCT02573259|Drug|PF-06801591|IV every 21 days (Part 1)
16043277|NCT02573259|Drug|PF-06801591|300 mg SC every 28 days (Part 1 and 2)
16043278|NCT02573246|Behavioral|Cognitive Restructuring|Cognitive restructuring is a cognitive behavioral intervention through which participants learn how to think differently about stressful events in order to feel less emotional arousal. Specifically, participants learn how to distance themselves from the situation, think of the memory as just a memory, or focus on alternative explanations or facets of the situation that are less emotionally upsetting.
16043279|NCT02573246|Device|rTMS|rTMS is a neurostimulation intervention where the participant receives 15 minutes of high frequency (10 HZ) transcranial magnetic stimulation pulses
16043280|NCT02573246|Device|Sham rTMS|Sham rTMS is a placebo intervention aimed to mimic the effects of repetitive transcranial magnetic stimulation with no known direct benefit for the participant.
16043281|NCT02573233|Drug|Placebo|Pharmaceutical form:solution Route of administration: subcutaneous
16043282|NCT02573233|Drug|Dupilumab SAR231893/REGN668|Pharmaceutical form:solution Route of administration: subcutaneous
16043283|NCT02573233|Drug|fluticasone propionate and salmeterol|Pharmaceutical form:inhalation aerosol, inhalation powder Route of administration: inhaled
16043285|NCT02573233|Drug|mometasone furoate and formoterol|Pharmaceutical form:inhalation aerosol Route of administration: inhaled
16043286|NCT02573220|Biological|Cetuximab|Given IV
16043287|NCT02573220|Drug|Fluorouracil|Given IV
16043288|NCT02573220|Drug|Irinotecan Hydrochloride|Given IV
16043289|NCT02573220|Drug|Leucovorin Calcium|Given IV
16043290|NCT02573194|Dietary Supplement|Breakfasts varying in protein source content on appetite|In this randomized, within-subject study, subjects are asked to consume 4 iso-energetic and iso-volumetric puddings as breakfast (20% of estimated energy requirements) with varying distribution of protein sources. The objective is to identify the protein source and the distribution on suppressing appetite.
16043291|NCT02573181|Biological|V114|V114 contains 2 µg of serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F, and 4 μg of serotype 6B; and 30 µg of CRM₁₉₇ and 125 µg of Aluminum Phosphate Adjuvant (APA) per 0.5 mL dose.
16043292|NCT02573181|Biological|Prevnar 13™|Prevnar 13™ contains 2.2 μg of serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, and 23F, and 4.4 μg of serotype 6B; and 34 μg of CRM₁₉₇ and 125 μg of aluminum per 0.5mL dose.
16043293|NCT02573168|Genetic|GeneSight Psychotropic (GEN)|Patient DNA will be collected for all subjects and measured for variations in drug target genes and in drug metabolizing genes.Recommendations for optimal choices and dose adjustments for the 33 most commonly prescribed antidepressant and antipsychotic medications will be provided to subjects randomized to the GEN arm. This pharmacogenomic-based interpretive report will be provided to treating clinicians of patients in the GEN arm of the study, allowing clinicians to use the report to support their treatment decisions.
16043294|NCT02573168|Genetic|Enhanced-GeneSight Psychotropic (E-GEN)|The E-GEN test incorporates into the existing GEN product new markers that are predictive of side effect of antipsychotic-induced weight gain (AIWG). The pharmacogenomic-based interpretive report from E-GEN will be provided to treating clinicians of patients in the E-GEN arm of the study, allowing clinicians to use the report to support their treatment decisions.
16043295|NCT02573168|Other|Treatment as Usual (TAU)|Subjects randomized to the TAU arm will also require collection of patient DNA. A pharmacogenomic-based interpretive report will be generated from GEN, however, this report is not provided to the treating clinician until completion of the study.
16043296|NCT02573155|Drug|Dose 1, AZD8871 50 μg (Part 1)|50 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)
16043297|NCT02573155|Drug|Dose 2, AZD8871 100 μg (Part 1)|100 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)
16043298|NCT02573155|Drug|Dose 3, AZD8871 300 μg (Part 1)|300 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)
16043299|NCT02573155|Drug|Dose 4, AZD8871 600 µg (Part 1)|600 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)
16043300|NCT02573155|Drug|Dose 5, AZD8871 1200 µg (Part 1)|1200 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)
16043301|NCT02573155|Drug|Dose 6, AZD8871 1800 μg (Part 1)|1800 µg of AZD8871 on Day 1; each dose of AZD8871 inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)
16043302|NCT02573155|Drug|Placebo, AZD8871 placebo (Part 1)|AZD8871 placebo on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)
16043303|NCT02573155|Drug|Treatment A, AZD8871 dose A (Part 2)|AZD8871 dose A once on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler (Genuair®)
16043304|NCT02573155|Drug|Treatment B, AZD8871 dose B (Part 2)|AZD8871 dose B once on Day 1; each dose of AZD8871 placebo inhalation powder will be administered via single-dose dry powder inhaler(Genuair®)
16043305|NCT02573155|Drug|Treatment C, Indacaterol 150 μg (Part 2)|150 μg of Indacaterol once on Day 1; each dose of Indacaterol dry inhalation powder will be administered via a dry powder inhaler (Onbrez Breezhaler®) as 1 hard capsule
16043306|NCT02573155|Drug|Treatment D, Tiotropium 18 μg (Part 2)|18 μg of Tiotropium once on Day 1; each dose of Indacaterol dry inhalation powder will be administered via a dry powder inhaler (HandiHaler®) as 1 hard capsule
16043307|NCT02573142|Behavioral|Bull City Healthy and Fit|Integrated model of child obesity treatment including clinical care plus community-based program for family-based experiential learning of healthy habits.
16043308|NCT02573142|Behavioral|Healthy Lifestyles Clinic|Clinic-only model of care including clinical care and educational materials
16043309|NCT02573129|Other|Red Meat Restricted|restrict intake of red meat while a Mediterranean diet
16043310|NCT02573129|Other|Red Meat Rich|Mediterranean diet rich in red meat
16043311|NCT02573116|Procedure|scaling and root planing|full-mouth intensive removal of subgingival dental plaque biofilms with the use of scaling and root planing after the administration of local anesthesia
16043312|NCT02573090|Procedure|Non-invasive resin based fissure sealing|The dentists use resin based fissure sealants of own choice, and follow their usual clinical procedures based on the instructions from the manufacturer and the guidelines from The Department of Cariology and Endodontics, University of Copenhagen, DK
16043313|NCT02573090|Procedure|Invasive resin based restoration|The dentists use preparation design and resin composites of own choice, and follow their usual clinical procedures based on the instructions from the manufacturer and the guidelines from The Department of Cariology and Endodontics, University of Copenhagen, DK
16043314|NCT02573064|Drug|Colistin|
16043315|NCT02573064|Drug|Tigecycline|
16043316|NCT02573064|Drug|Vancomycin|
16043317|NCT02573051|Drug|Misoprostol|800 µg of misoprostol (Misotac 200 µg Sigma for Pharmaceutical Industries)
16043318|NCT02573051|Drug|Isosorbide mononitrate|40 mg isosorbide mononitrate (Effox 40 mg Minipharma Company)
16043319|NCT02573051|Other|placebo|
16043320|NCT02573038|Drug|Aflibercept|The patients are followed on a monthly basis until 52 weeks. Intravitreal injections of aflibercept at a dosage of 2 mg are initiated at inclusion (mandatory injection) followed by mandatory injections at week 4, week 8, week 20, week 32 and week 44. During the other visits, an injection can be performed in case of CNV activity (PRN regimen).Therefore, each patient receives between 6 and 13 injections in the whole study.
16043321|NCT02573025|Drug|PEG-IFN alfa-2a BA-free formulation (Test)|Participants will receive single injection of 180 micrograms (mcg) of PEG-IFN alfa-2a BA-free formulation, subcutaneously via prefilled syringe in either period 1 and 2 (each period having 35 days).
16043322|NCT02573025|Drug|PEG-IFN alfa-2a market formulation (Reference)|Participants will receive single injection of 180 mcg of PEG-IFN alfa-2a market formulation, subcutaneously via prefilled syringe in either period 1 and 2 (each period having 35 days).
16043323|NCT02573012|Drug|Placebo matched to prednisone|Participants will receive placebo matched to prednisone orally for 24 weeks.
16043324|NCT02573012|Drug|Prednisone|Participants will receive prednisone either at a constant dose of 5 mg/day, or 5 mg/day with 1 mg decrements every 4 weeks orally for 24 weeks.
16043325|NCT02573012|Biological|Tocilizumab|Participants will receive tocilizumab at a dose of 162 mg once a week subcutaneously for 24 weeks.
16043326|NCT02572999|Procedure|Not applicable (observational design)|
16043327|NCT02572986|Drug|Permethrin|
16043328|NCT02572973|Other|Acoustic Neuromodulation (ANM)|The purpose of this study is test the safety of the Acoustic Neuromodulation (ANM) treatment and see what effects it has on your child's anxiety symptoms. Observation and anecdotal evidence suggest that this is an effective intervention for anxiety disorders. This is the first research study to test this theory, and could lead to more robust studies in the future. This study intends to assess the efficacy of this type of intervention for children with an anxiety disorder. As this is only a pilot study, the results will also inform the design and execution of future research on this treatment. We hope to add to the growing literature supporting novel treatment approaches for affected individuals.
16043329|NCT02572960|Drug|Valsartan|2 weeks of Valsartan 80 mg per day
16043330|NCT02572960|Drug|Placebo Valsartan|2 weeks of Placebo Valsartan, one tablet per day. Placebo tablets are identical in regards to size and appearance to the experimental intervention tablet.
16043331|NCT02572960|Dietary Supplement|Cholecalciferol|12 weeks of daily cholecalciferol treatment, 70 microgram per day
16043332|NCT02572960|Dietary Supplement|Placebo cholecalciferol|12 weeks of daily Placebo cholecalciferol treatment. Placebo tablets are identical in regards to size and appearance to the experimental intervention tablet.
16043333|NCT02572947|Drug|Dolutegravir|
16043334|NCT02572921|Behavioral|Positive Psychotherapy|"The Positive Psychotherapy Group Treatment was developed by Martin Seligman and Tayyab Rashid (2013) and consists of 14 weekly group sessions of 2 hours. The strictly manualized program includes the following components:
~positive orientation and introduction, character strengths, signature strengths, good vs. bad memories, forgiveness, gratitude, satisficing vs. maximising, meaningful life, posttraumatic growth, hope and optimism, positive communication, signature strengths of others, savouring and slowness, altruism and the last session is about the integration of all these components to the full life."
16043335|NCT02572921|Behavioral|Cognitive behavioral therapy|This well-established, cognitive-behavior group therapy was developed by Schaub, Roth and Goldmann (2006) and consists of 12 weekly group sessions of 2 hours. The strictly manualized program includes the following components: education, building up activities, cognitive restructuring, relapse prevention. Moreover, there are 2 sessions added to the standard program: one session concerning savouring and the other one concerning stress reduction. Thus the whole program consists of 14 sessions.
16043336|NCT02572908|Other|Sourdough wheat bread|
16043337|NCT02572908|Other|Regular yeast baked toast bread|
16043338|NCT02572908|Other|Gluten-free diet|Gluten-free diet excluding even oats and buckwheat. Rice, quinoa, corn and potato allowed as grains/pseudo-grains
16043339|NCT02572895|Dietary Supplement|Cranberry extract|The aim of this clinical trial is to assess efficacy of an optimal dose of cranberry extract compared to a control dose on mean number of new UTIs for a 6-month period follow-up in women. Participants will be randomly assigned to the optimal dose or control dose treatment at their first visit at the Institute of Nutrition and Functional Foods. This intervention includes three visits at 0, 12 and 24 weeks. At the first visit, women will have to complete questionnaires to provide sociodemographic, medication and natural health products, health antecedents and quality of life information and to document risk factors related to UTIs. A 24-hour recall questionnaire about consumption of PACs will also be completed. A urinary sample analysis and culture as well as a pregnant test will also be performed. Compliance regarding capsules' intake and potential side effects will be documented. The completion of questionnaires and urinary measurements will be repeated at weeks 12 and 24.
16043340|NCT02572882|Dietary Supplement|p-inulin|12 week self-administered treatment phase
16043341|NCT02572869|Other|physical exam|Patients will be examined by the treating physician or his/her designee (Fellow). The examining physician will complete an 11-item clinical examination form about the patient's clinical function. This examination assesses lip competence, tongue movement, oral mucosa, dental state, mouth opening, speech, drooling, diet, appearance, oral sensation, and shoulder movement. Where appropriate, the physician will ask the patient questions regarding items on the questionnaire to ensure the completeness and accuracy of the outcome assessment.
16043342|NCT02572869|Behavioral|questionnaires|"The participating patients will be asked to complete three questionnaires:
~(1) The European Organization for Research and Treatment of Cancer (EORTC) Head and Neck questionnaire (EORTC H&N 35) to assess their quality of life as it relates to their mandible function and aesthetic appearance (2) The EORTC QLQ-C30, which assesses overall health-related quality of life (3) The FACE-Q Oncology Module: Mandibulectomy, which contains questions regarding both functional and aesthetic outcomes."
16043343|NCT02572856|Device|Continuous Glucose Monitor (CGM)|Apply Dexcom Gen 6 Professional CGM sensor at least 2.5 hours prior to surgery Configure CGM so that its measurements are blinded. Setup CGM to make continuous glucose measurements during and after surgery. Download CGM measurement data after study and compare measurements against glucose measurements made for clinical care.
16043344|NCT02572843|Drug|MEDI4736 (anti-PD-L1)|fixed dosing 750 mg
16043345|NCT02572830|Behavioral|Delayed Bilateral Eye Movements|Bilateral Eye Movements followed by a 10 min delay after reactivation of fear-memory.
16043346|NCT02572830|Behavioral|Undelayed Bilateral Eye Movement|Bilateral Eye Movements followed by no delay after reactivation of fear-memory. reactivation of the fear memory trace during which the reactivated memory is assumed to be in a labile state.
16043347|NCT02572817|Biological|High-titer anti-influenza plasma|Human plasma (FFP or FP24, 225-350 mL per unit or pediatric equivalent) with both an influenza A/H1N1 and A/H3N2 HAI titer of at least 1:80
16043348|NCT02572817|Biological|Low-titer anti-influenza plasma|Human plasma (FFP or FP24, 225-350 mL per unit or pediatric equivalent) with both an influenza A/H1N1 and A/H3N2 HAI titer of 1:10 or less
16043349|NCT02572804|Device|Epidural|Patients in this group will have an epidural inserted in a standard fashion, prior to the induction of anesthesia. These will be infused with 0.125% Bupivicaine at an initial rate of 5mls/hour, titrated to response. Patients will also receive a patient controlled analgesia with hydromorphone 0.2mg/ml, bolus of 200 micrograms with 6 minute lock out (variable in accordance with anesthetic preference).
16043350|NCT02572804|Device|Rectus Sheath Catheters|Patients in this group will have surgically inserted rectus sheath catheters (bilaterally), immediately prior to closure of the anterior abdominal wall. These will be infused with 0.125% Bupivicaine at 5mls an hour at a standard rate.Patients will also receive a patient controlled analgesia with hydromorphone 0.2mg/ml, bolus of 200 micrograms with 6 minute lock out (variable in accordance with anesthetic preference).
16043351|NCT02572791|Drug|Chlorhexidine|
16043352|NCT02572791|Drug|Mupirocin|
16043353|NCT02572791|Behavioral|Household cleaning|
16043354|NCT02572778|Procedure|Local biopsy in the tumor|A tumor biopsy of 0.5 cm2 or more will be collected from every patient during surgery or endoscopy after informed consent and if there is enough material after review by the pathologist.
16043355|NCT02572765|Other|PET/CT scan|PET/CT scan
16043356|NCT02572752|Drug|Nintedanib|1 soft gelatine capsule, single dose, oral
16043357|NCT02572752|Drug|Nintedanib|Nintedanib, 2 soft gelatine capsules, single dose, oral
16043358|NCT02572752|Drug|Nintedanib|
16043359|NCT02572739|Device|PICCO|measurements based on thermodilution
16043360|NCT02572739|Device|NICCOMO|measurements based on impedance
16043361|NCT02572726|Device|active repeated transcranial magnetic stimulation|ten daily sessions with active 10Hz 20 min-long stimulation over the primary motor cortex
16043362|NCT02572726|Device|'sham' repeated transcranial magnetic stimulation|ten daily sessions with 'sham' 10Hz 20 min-long stimulation over the primary motor cortex
16043363|NCT02572713|Procedure|Biofluid samplings|Biofluid samplings (blood, saliva, and cerebrospinal fluid (CSF)
16043364|NCT02572713|Procedure|Tissue samplings|Tissue samplings (skin, colon, submandibular gland)
16043365|NCT02572713|Drug|DaTSCAN™|
16043366|NCT02572700|Other|Clinical examination, blood sampling, ultrasonic assessment, and questionnaires|Visits include clinical examination, questionnaires (pain, comorbidity, lifestyle, work status) and ultrasonography of joints and entheses, blood samples, and only at baseline x-ray of hands and feet.
16043367|NCT02572687|Drug|Ramucirumab|Administered IV
16043368|NCT02572687|Drug|MEDI4736|Administered IV
16043369|NCT02572674|Other|Experimental follow up|Neuropsychological assessment (intellectual functioning, episodic verbal memory, processing speed, attention, working verbal memory, working visual memory, executive function)
16043370|NCT02572674|Genetic|Genetic sample|Blood samples
16043371|NCT02572661|Radiation|radiation in Squamous Head and Neck Cancer|
16043372|NCT02572648|Other|Brain Imaging (Neuroimaging)|"Magnetic Resonance Imaging (MR) will be acquired on a research dedicated Siemens 3Tesla TIM TRIO MRI scanner with a 32-channel head coil.The MRI scanning protocol will have scans to measure voxelwise and whole-brain measures of grey matter (GM) volumes through a high resolution T1-weighted (T1W) multi-echo magnetization prepared gradient echo (MEMPRAGE) anatomic scan.
~Total time in scanner will be approximately 53 minutes."
16043373|NCT02572648|Other|Cognitive Function Assessment|Cognitive function will be assessed using several batteries; the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), the Controlled Oral Word Association Test (COWA), the Color Trails 1 & 2, the WAIS-III Digit Span and Letter Number Sequence test, the Stroop Test, and the California Computerized Assessment Package Reaction Time test (CALCAP).
16043374|NCT02572635|Biological|PnuBioVax|Three administrations (by intramuscular injection) given 28 days apart to 9 subjects.
16043375|NCT02572635|Biological|Placebo|Placebo administered by intramuscular injection to 3 subjects in each cohort. Three administrations given 28 days apart.
16043376|NCT02572622|Other|non -surgical spinal decompression therapy|it is a kind of traction therapy, it has an special traction design which can provide intermittent traction as to herniation levels.
16043377|NCT02572622|Other|deep friction massage,|deep friction massage is a kind of massage targeting deep muscles for decreasing pain and increasing function
16043378|NCT02572622|Other|electrotherapy|electrotherapy is consist of hot pack, ultrasound and TENS. electrotherapy agents were help decreasing pain, increasing metabolism of tissues.
16043379|NCT02572622|Other|exercise|special lumbar stabilization exercises were applied in advanced protocol.
16043380|NCT02572609|Drug|Ambroxol hydrochloride soft pastille|
16043381|NCT02572609|Drug|Mucosolvan ® adult syrup|
16043382|NCT02572596|Drug|rhTPO|rhTPO was administered 15 000 U/d once daily by subcutaneous injection from day 5-7 after chemotherapy and until the stem cell collection was completed.
16043383|NCT02572596|Drug|CTX|CTX 2.5/m2 for 2 days.
16043384|NCT02572596|Drug|-CSF|10 ug/kg/d of G-CSFwas administered from the WBC was lower than 1×10^9/L following bejing of chemotherapy or no later than day 7after chemotherapy. G-CSF was subcutaneously administered once daily until the stem cell collection was completed.
16043385|NCT02572583|Drug|Liugan Shuangjie Heji|
16043386|NCT02572583|Drug|Shufeng Jiedu Capsule|
16043387|NCT02572583|Drug|Oseltamivir Phosphate Capsule|
16043388|NCT02572570|Device|Filtek Bulk Fill Posterior|Tooth (teeth) affected by dental caries or with an existing defective filling restored using the materials listed (Filtek Bulk Fill Posterior). Procedures done using local anesthesia and following ordinary restorative techniques.
16043389|NCT02572570|Device|Filtek Supreme Ultra|Tooth (teeth) affected by dental caries or with an existing defective filling restored using the materials listed (Filtek Supreme Ultra). Procedures done using local anesthesia and following ordinary restorative techniques.
16043390|NCT02572557|Device|TruFreeze Spray CryoTherapy|TruFreeze Spray CryoTherapy using liquid nitrogen
16043391|NCT02572557|Drug|Liquid nitrogen|TruFreeze Spray CryoTherapy using liquid nitrogen
16043392|NCT02572544|Device|Trayner Pinhole Glasses (Trayner Glasses, Ivybridge Devon, U.K.)|Wearing multiple and single pinhole glasses
16043426|NCT02572258|Other|Nutritional cookie|
16043393|NCT02572531|Dietary Supplement|L. reuteri DSM 17938/ATCC PTA|Ingestion of active lozenge three times daily for 2 weeks
16043394|NCT02572531|Dietary Supplement|Placebo|Ingestion of placebo lozenge three times daily for 2 weeks
16043395|NCT02572505|Drug|Truvada|Female patient will take Truvada and use condoms for each act of intercourse except once at the optimal time for fertility.
16043396|NCT02572492|Drug|Induction with CAR-CY-DEX and conditioning with carfilzomib and highdose melphalan|"All patients entering the study receive four series of CAR-CY-DEX (Cycle 1 with iv carfilzomib 20 mg/sqm on days 1 and 2, and iv carfilzomib 36 mg/sqm on days 8, 9, 15 and 16. Cycle 2 - 4 with iv carfilzomib 36 mg/sqm on days 1, 2, 8, 9, 15 and 16. P.o. cyclophosphamide 300 mg/sqm on days 1, 8 and 15 and p.o. dexamethasone 20 mg on days 1, 2, 8, 9, 15 and 16 in each 28-days series)
~Subsequently all patients receive the conditioning regimen:
~Iv carfilzomib 27 mg/sqm on day -2 and -1 Iv melphalan 200 mg/sqm on day -2 > 2.0 m CD34+ stem cells/kg body weight on day 0"
16043397|NCT02572492|Drug|Carfilzomib/dexamethasone maintenance|Maintenance therapy two months after salvage HDT with iv carfilzomib 27 mg/sqm every second week and p.o. dexamethasone 20 mg every second week. The maintenance dose of carfilzomib will be escalated to 56 mg/sqm after 4 weeks provided acceptable side effects.
16043398|NCT02572492|Drug|Observation without carfilzomib/dexamethasone maintenance|Observation without carfilzomib/dexamethasone maintenance
16043399|NCT02572466|Other|Hemodialysis|ESRD group received long-term hemodialysis
16043400|NCT02572453|Drug|Onalespib|Given IV
16043401|NCT02572440|Procedure|Sorin XTRA/Sorin Group,|
16043402|NCT02572427|Other|Education for intubation skills|Routine training in neonatal resuscitation, intensive cognitive and hands on training for intubating neonates using manikins in a simulation lab.
16043403|NCT02572427|Other|No added education for intubation skills|Routine training in neonatal resuscitation but no added experience in simulation lab.
16043404|NCT02572414|Behavioral|Health Promotion Intervention|Men Together Making a Difference Health Promotion Intervention, which included three, 3-hour weekly sessions, implemented in small groups by trained facilitators using scripted manuals, was designed to increase self-efficacy, outcome expectancy, and skills for behaviors tied to cardiovascular disease, diabetes, hypertension, and cancer. It encouraged men to adhere to guidelines for physical activity, 5-a-Day diet, and colon cancer screening. It encouraged at least 30 min of moderate-intensity aerobic activity on 5 days or at least 20 min of vigorous-intensity aerobic activity on 4 days and muscle-strengthening activity on at least 2 days each week. Participants identified their personal barriers to engaging in the recommended behaviors and strategies for surmounting those barriers.
16043405|NCT02572414|Behavioral|Health Awareness Control Intervention|Health Awareness Control Intervention consisted of one 1-hour small-group session led by a trained facilitator. Participants viewed and discussed video clips on physical activity, fruit and vegetable consumption, and colon cancer screening.
16043406|NCT02572401|Behavioral|STAND HIV Risk Reduction Intervention|STAND HIV Risk Reduction Intervention, designed to increase consistent condom use and reduce other sexual risk behaviors, is implemented in small groups over 2 weekly 135-minute sessions. It draws on social cognitive theory, the reasoned action approach, and focus groups, a prospective survey, and an intervention pilot test with African American men. It contains culturally appropriate video clips, interactive activities, brainstorming, role-playing, and discussions designed to affect hypothesized mediators of risk-reducing behavior, including outcome expectancies about the effects of condom use on sexual enjoyment; self-efficacy and skill to have condoms available and to stop to use condoms or refuse unsafe sex even when aroused; and self-efficacy and skill to negotiate condom use.
16043407|NCT02572401|Behavioral|Text Messaging Intervention|Text Messaging Intervention participants receive text messages designed to increase the consistent use of condoms and to reduce other sexual risk behaviors. They receive 3 times a week text messages that ask about their sexual behavior and condom use that day and are asked to respond with either a 1 or 2 numeric response to indicate yes or no. Based on their responses, they receive either an affirming, pro safe-sex text message or a cautionary text against unprotected sex.
16043408|NCT02572388|Biological|R21|
16043409|NCT02572388|Biological|Matrix-M1|
16043410|NCT02572375|Drug|Codeine Phosphate/Guaifenesin ER Tablet|Provide two Codeine Phosphate and Guaifenesin ER Tablet every 12 hours for 6 1/2 days.
16043411|NCT02572375|Drug|Codeine Phosphate/Guaifenesin IR Tablet|Provide one Codeine Phosphate and Guaifenesin IR Tablet every 4 hours for 6 1/2 days
16043412|NCT02572362|Other|No intervention in this retrospective study|No Intervention in this retrospective Analysis. All patients included did receive Radiation therapy Independent of this study
16043413|NCT02572349|Drug|IW-1701|
16043414|NCT02572349|Drug|Matching Placebo|
16043415|NCT02572336|Drug|THR-18|THR-18 is an 18-mer peptide derived from the sequence of human plasminogen activator inhibitor 1 (PAI-1), having the ability to bind to a site of tissue plasminogen activator (tPA) distal to its catalytic site and uncouple the beneficial clot-dissolving properties of tPA from its deleterious non-fibrinolytic effects.
16043416|NCT02572336|Drug|Placebo|Placebo is a THR-18 lookalike, to be administered with tPA.
16043417|NCT02572336|Drug|Tissue Plasminogen Activator (tPA)|tPA is a thrombolytic agent. tPA is not an investigational drug.
16043418|NCT02572323|Drug|Tesamorelin|Tesamorelin is an injectable medication already approved by the U.S. FDA to treat abdominal fat accumulation in HIV
16043419|NCT02572310|Device|Simplex High Viscosity Bone Cement|high viscosity bone cement for total knee replacement
16043420|NCT02572297|Other|video-EEG|Registration of seizures during video-EEG
16043421|NCT02572284|Radiation|Stereotactic Body Radiation Therapy (SBRT)|The first group of patients to enter the study will receive 5 Gy of SBRT per day for 5 days, the second group will receive 6 Gy per day for 5 days. Each treatment will take about 3 minutes and be given as an outpatient at Moffitt Cancer Center.
16043422|NCT02572284|Procedure|Prostatectomy|About 4-6 weeks after SBRT, participants will have a prostatectomy.
16043423|NCT02572284|Other|Quality of Life Questionnaires|Patient assessed health-related quality of life (HRQOL). Quality of Life (QOL) will be assessed using Prostate Symptom Score (IPSS), rectal assessment scale (RAS), sexual health inventory for men (SHIM), and Expanded Prostate Cancer Index Composite (EPIC) patient questionnaires: administered prior to SBRT, and at 2 weeks, 4 weeks, 2 months and then every 3 months up to 18 months post-prostatectomy.
16043424|NCT02572271|Procedure|Rubins Mastopexy|The surgical technique described by Rubin is performed. No other intervention.
16043427|NCT02572245|Device|PF-06410293 PFS|PF-06410293 40 mg administered subcutaneously by Prefilled syringe
16043428|NCT02572245|Device|PF-06410293 PFP|PF-06410293 40 mg administered subcutaneously by prefilled pen
16043429|NCT02572232|Device|Combitube, Easytube, Laryngeal masks|Supraglottic airway device
16043430|NCT02572219|Dietary Supplement|Nutraceutical compound|
16043431|NCT02572219|Dietary Supplement|Placebo|
16043432|NCT02572206|Radiation|PET/SPECT Scan|PET scan will be performed on a mCT scanner.
16043433|NCT02572206|Device|MRI scan|Structural MRI will be obtained to permit co-registration of PET images.
16043434|NCT02572193|Procedure|POEM|To determine the feasibility of same-day discharge following a POEM procedure
16043435|NCT02572180|Behavioral|EMG-based biofeedback training|
16043436|NCT02572180|Behavioral|NIRS-based neurofeedback training|
16043437|NCT02572167|Drug|brentuximab vedotin|1.8 mg/kg by intravenous (IV) infusion for up to 4 cycles
16043438|NCT02572167|Drug|nivolumab|3 mg/kg by intravenous (IV) infusion for up to 4 cycles
16043439|NCT02572154|Other|Blood and sperm samples|20 ml of blood and sperm samples for sperm DNA fragmentation exploration
16043440|NCT02572141|Drug|Perioperative chemotherapy with mFOLFOX6 or CAPOX regimens|mFOLFOX6 (IV oxaliplatin given over 120 min at a dose of 85 mg/m2 on day 1 followed by IV leucovorin 400 mg/m2 over 2h, IV bolus 5-Fluorouracil 400 mg/m2 and IV infusional 5-Fluorouracil 2400 mg/m2 over 46h every 14 days) for 6 cycles followed by colectomy (3 to 5 weeks after) followed by mFOLFOX6 (6 cycles); CAPOX (IV oxaliplatin given over 120 min at a dose of 130 mg/m2 on day 1, oral capecitabine 1000 mg/m2 twice daily on days 1 through 14 every 21 days) for 4 cycles followed by colectomy (3 to 5 weeks after) followed by CAPOX (4 cycles).
16043441|NCT02572141|Drug|Postoperative chemotherapy with mFOLFOX6 or CAPOX regimens|Colectomy (maximum 4 weeks after randomization) followed by mFOLFOX6 (IV oxaliplatin given over 120 min at a dose of 85 mg/m2 on day 1 followed by IV leucovorin 400 mg/m2 over 2h, IV bolus 5-Fluorouracil 400 mg/m2 and IV infusional 5-Fluorouracil 2400 mg/m2 over 46h every 14 days) for 12 cycles; Colectomy (maximum 4 weeks after randomization) followed by CAPOX (IV oxaliplatin given over 120 min at a dose of 130 mg/m2 on day 1, oral capecitabine 1000 mg/m2 twice daily on days 1 through 14 every 21 days) for 8 cycles
16043442|NCT02572128|Other|Fortified rice|"Study 1: Hot or cold extruded rice fortified test meals fortified with Ferric Pyrophosphate and Zinc oxide will be administered - subjects serve as their own controls.
~Study 2: Hot extruded rice or coated rice fortified with Ferric Pyrophosphate and Zinc Oxide will be administered.
~Regular rice fortified with Ferrous Sulfate (FeSO4) will act as a control in study 2."
16043443|NCT02572115|Behavioral|Akutknappen - used|A caller chooses to bypass the telephone waiting line by pressing the emergency access button
16043444|NCT02572115|Behavioral|Akutknappen - not used|A caller chooses NOT to bypass the telephone waiting line.
16043445|NCT02572102|Dietary Supplement|Energy Drink|Energy Drink, two 16oz containers consumed in 45 minutes
16043446|NCT02572102|Dietary Supplement|Panax Ginseng|Panax Ginseng, lime juice, water and cherry flavoring
16043447|NCT02572102|Other|Placebo|Lime juice, water and cherry flavoring
16043448|NCT02572089|Drug|Naloxone|
16043449|NCT02572076|Device|Motus Cleansing System|
16043450|NCT02572050|Procedure|Distal Gastrectomy with D2 LND|Robotic Distal Gastrectomy with D2 lymphadenectomy(#7, #8a, #9, #11p, #12a in Japanese Classification) for patient with stage II or III gastric cancer
16043451|NCT02572024|Device|BAT|Baroreflex activation therapy device ON
16043452|NCT02572024|Other|Placebo|Baroreflex activation therapy device OFF
16043453|NCT02572011|Other|Home-based Games Console Balance Training|The balance training intervention involves completing prescribed balance tasks for a minimum of 60 minutes per session, three times a week for 12 weeks (minimum intervention time of 2160 minutes) in their own home. Participants will perform the balance related Wii Fit games that have been suggested previously by professional bodies and amputee therapists (BACPAR Ossur Wii Fit Exercise Recommendations).
16043454|NCT02571998|Drug|Omiganan (CLS001) Topical Gel|
16043455|NCT02571998|Drug|Vehicle Topical Gel|
16043456|NCT02571985|Device|Zenith® Branch Endovascular Graft-Iliac Bifurcation System|Zenith® Branch Endovascular Graft-Iliac Bifurcation (Branch Graft) with the ConnectSX™
16043457|NCT02571972|Drug|Dorzolamide-timolol|On enrollment, eligible patients will be started on topical dorzolamide-timolol in the study eye twice daily for the study duration
16043458|NCT02571959|Drug|amoxicillin and clavulanic acid|Day 1 : a dose of amoxicillin and clavulanic acid 1g / 200mg will be intravenously administered
16043459|NCT02571959|Drug|amoxicillin and clavulanic acid|Day 2 : a dose of amoxicillin and clavulanic acid 1g / 125mg will be administered by oral route
16043460|NCT02571946|Radiation|Proton beam therapy|
16043461|NCT02571933|Other|Pre-treatment Faces Pain Scale - Revised|Patients will be asked to answer the Faces Pain Scale - Revised as an assessment of pain prior to standard analgesia dosing.
16043462|NCT02571933|Other|Post-treatment Faces Pain Scale - Revised|Patients will be asked to answer the Faces Pain Scale - Revised 1-2 hours after receiving standard analgesia as an assessment of pain.
16043463|NCT02571933|Other|Cognitive interview|Patients will answer a series of questions pertaining to the pain scale's ease of use, intuitive nature, and cultural appropriateness.
16043464|NCT02571907|Device|Zenith® Branch Endovascular Graft-Iliac Bifurcation,|Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation.
16043465|NCT02571907|Device|Atrium iCAST™|Implantation of Atrium iCAST
16043466|NCT02571907|Device|Zenith® Flex AAA Endovascular Graft|Implantation of the Zenith Flex Endovascular Graft
16043467|NCT02571894|Other|Subclinical cardiotoxicity surveillance and treatment|Intervention arm receives cardiology assessment and intervention.
16043468|NCT02571881|Procedure|Caesarean section|After caesarean section oxycodone or oxycodone-naloxone prolonged release tablet twice a day is started for pain medication
16043469|NCT02571881|Drug|Oxycodone|
16043470|NCT02571881|Drug|oxycodone-naloxone|
16043471|NCT02571868|Device|Optimization CRT-D|
16043472|NCT02571855|Drug|ACT-541468 (hydrochloride salt)|Hard-gelatin capsules (strength: 5 mg and 25 mg)
16043473|NCT02571855|Drug|ACT-541468 (free base)|Soft capsules (strength: 25 mg)
16043474|NCT02571855|Drug|Placebo|Placebo capsules matching the ACT-541468 formulations
16043476|NCT02571842|Drug|ACEI/ARB and corticosteroids|"ACEI or ARB will be prescribed as high as tolerable dose.
~Prednisolone will be prescribed starting as 0.5 mg/kg/day then taper off to 5 mg/day within 6-8 weeks"
16043477|NCT02571829|Drug|ribociclib|Oral, 600 mg x 1 a day, duration - according to response
16043478|NCT02571816|Drug|ASP2215|oral
16043479|NCT02571803|Behavioral|Dietary And Lifestyle Counseling|The DASH (Dietary Approaches to Stop Hypertension) diet is a dietary pattern of proven effect on arterial blood pressure reduction. It is rich in fruits, vegetables, whole grains, and low-fat dairy foods; includes meat, fish, poultry, nuts, and beans; and is limited in sugar-sweetened foods and beverages, red meat, and added fats. Dietary counseling will be provided during each of 7 control visits within the 12-month time of observation.
16043480|NCT02571803|Other|Optimal Medical Treatment|Optimal Medical Treatment as per 2013 ESC Guidelines on the Management of Stable Coronary Artery Disease.
16043481|NCT02571790|Behavioral|Relaxation optimized virtual reality|
16043482|NCT02571790|Behavioral|Classical relaxation (without Virtual Reality)|
16043483|NCT02571777|Drug|QVM149 150/50/160|
16043484|NCT02571777|Drug|QVM149 150/50/80|
16043485|NCT02571777|Drug|QMF149 150/320|
16043486|NCT02571777|Drug|QMF149 150/160|
16043487|NCT02571777|Drug|salmeterol/fluticasone|
16043488|NCT02571764|Other|Nutritional Oats Cookie|
16043489|NCT02571751|Device|UNIGEL Silicone Gel-Filled Breast Implant|
16043490|NCT02571738|Biological|CHAM|The treatment indication is for chronic diabetic foot ulcers that can accommodate up to one 5cm x 5cm piece of CHAM
16043491|NCT02571738|Other|Control|Standard of Care
16043492|NCT02571725|Drug|Olaparib|Olaparib starts concomitantly with the first dose of Tremelimumab
16043493|NCT02571725|Drug|Tremelimumab|3 to 6 patients will be treated at 10 mg/kg depending on RLT observed in the first 3 patients. If 0 out of 3 or 1 out of 6 patients experienced a RLT at 10 mg/kg, then this dose will be considered at the recommended phase 2 dose (RP2D). If 2 out of 6 patients experience RLT at this dose within 56 days, then dose reductions as detailed in the Arm description will be carried out.
16043494|NCT02571712|Drug|bimatoprost 0.03% plus timolol 0.5%|1 drop of bimatoprost 0.03% plus timolol 0.5% (GANFORT®) instilled in the affected eye once daily.
16043495|NCT02571699|Other|Subgluteal Nerve Block|ultrasound-guided subgluteal sciatic nerve block.
16043496|NCT02571686|Device|Surveyor S4|
16043497|NCT02571673|Behavioral|Assessments|Usability outcomes will come from patient surveys and interviews and a nurse practitioner interview in Aim 1: Part 1. In Aim 1: Part 2, patients and their primary care providers will complete online surveys regarding feasibility. Health outcomes and data regarding health care actions will be collected from HN-STAR and the clinic note will be collected to assess feasibility of collecting these metrics in a future trial. Directly after each clinic visit, the NP will complete one brief online survey for each participant.
16043498|NCT02571660|Drug|GINA treatment fot asthma +vit.D low supplementation dose|Dose of 400 IU of vitamin D3 every 24 hours for 1 year + the standard treatment for asthma,
16043499|NCT02571660|Drug|GINA treatment fot asthma +vit.D high supplementation dose|Dose of 1600 IU of vitamin D3 be allocated each 24 hours for 1 year + standard treatment for asthma
16043500|NCT02571647|Other|Non interventional study|"Patients agreeing to participate in the study will have a cognitive assessment and geriatric assessment, carried out according to usual practices and grids clinical gerontology cluster.
~They will benefit in addition to a noninvasive screening and risk-free ophthalmic (visual acuity, intraocular pressure, examination of the eyelids and fundus)."
16043501|NCT02571634|Drug|Lazanda|Given pre radiofrequency ablation of the lumbar facet joints to see if patients can remain alert, and it provides relaxation and pain control.
16043502|NCT02571621|Device|Combitube|Intubation with Combitube
16043503|NCT02571608|Drug|Metformin|The study intervention involves Type II Diabetes Mellitus patient self-administered metformin vs. placebo according to regular dosing schedule and randomization. Both placebo and active drug will be over-encapsulated by pharmacy so that they will be indistinguishable to the personnel involved in the study.
16043504|NCT02571608|Drug|Placebo|The study intervention involves Type II Diabetes Mellitus patient self-administered metformin vs. placebo according to regular dosing schedule and randomization. Both placebo and active drug will be over-encapsulated by pharmacy so that they will be indistinguishable to the personnel involved in the study.
16043505|NCT02571595|Behavioral|Digital cognitive behavioural therapy for insomnia (dCBT-I)|dCBT-I is a computer-based treatment intervention that provides strategies to improve sleep and daytime function (concentration, productivity) in individuals with insomnia
16043506|NCT02571569|Drug|BAY1093884|Single escalating dose with a starting dose of 0.3 mg/kg for the first cohort. Drug will be administered via IV infusion over 1 hour and SC injection. Based on safety, PK and PD results the doses for the other cohorts will be determined.
16043507|NCT02571569|Drug|BAY1093884|Multiple dose cohort with a single 150-mg SC injection once a week for 6 weeks.
16043508|NCT02571556|Drug|Experimental: Dexamethasone Phosphate Ophthalmic solution (40 mg/mL) delivered by ocular iontophoresis consisting of 4.0 mA-min at 1.5 mA|Experimental: Dexamethasone Phosphate Ophthalmic solution (40 mg/mL) delivered by ocular iontophoresis consisting of 4.0 mA-min at 1.5 mA
16043509|NCT02571543|Drug|Ibuprofen|Beginning with 400mg Ibuprofen, 5 times. Depending on the outcome of stage 1 the treatment dose will increase to 800mg, 5 times.
16043510|NCT02571530|Drug|Intra-arterial Cerebral Infusion of Trastuzumab|
16043511|NCT02571517|Drug|Glucocorticoids|Patients assigned to experimental group (group 1) will receive iv methylprednisolone 2 mg/kg/day (divided in two doses) doses and/or oral prednisolone 2,5 mg/kg/day (divided in two doses) during 7 days.
16043512|NCT02571517|Other|Placebo|Patients assigned to control group (group 2) will receive iv/oral glucose 5% solution as placebo, 2 mg/kg/day (divided in two doses) during 7 days.
16043513|NCT02571504|Behavioral|Plasticity-based Adaptive Cognitive Remediation (PACR)|Web-based cognitive training program focused on improving attention and executive function (designed by Posit Science)
16043514|NCT02571491|Drug|Ketamine Hydrochloride|50 mg/ml, IV (in the vein) during surgery operation, followed by IV ketamine hydrocloride perfusion 2mcg/Kg/min before and until 72 hours after operation Number of Cycles: until progression or unacceptable toxicity develops.
16044152|NCT02567006|Other|Usual care|Health clinic nurse provides regular appointment in the vaccination card with no active reminders
16043515|NCT02571491|Other|Placebo|50 mg/ml, IV (in the vein) during surgery operation, followed by IV placebo perfusion 2mcg/Kg/min before and until 72 hours after operation
16043516|NCT02571491|Drug|Remifentanil|at doses of 0.3 mcg / kg / min during and until the end of the surgical operation
16043517|NCT02571491|Drug|Morphine hydrochloride|at the dose of 150 mcg / kg, 60 minutes before the extubation procedure and until 72 hours after operation by intravenous infusion
16043518|NCT02571478|Behavioral|Marriage Checkup|The MC adapted for primary care consists of three 30-minute appointments with the IBHC. Session 1 consists of discussing the of the couple's relationship history and each partner's primary strengths. Session 2 focuses on each partner's primary concern about the relationship. Session 3 is dedicated to providing feedback for the couple that identifies strengths, areas for possible improvement, and a menu of possible strategies or resources for the couple to consider pursuing.
16043519|NCT02571465|Other|Passive leg raising test and fluid challenge|
16043520|NCT02571452|Behavioral|Brief Behavioral Treatment for Insomnia|Participants will receive 4 weeks of Brief Behavioral Treatment for Insomnia (BBTI). BBTI consists of two in-person sessions, with the two other sessions conducted via telephone. BBTI emphasizes behavioral elements of insomnia treatment. Treatment begins with sleep education and discussion of the biological rhythms that influence sleep cycles. Next, a series of interventions are employed that are derived from sleep restriction and stimulus control techniques.
16043521|NCT02571452|Behavioral|Progressive Muscle Relaxation|Participants will receive 4 weeks of progressive muscle relaxation training (PMRT). PMRT consists of two in-person and two phone sessions. Treatment begins with training on muscle tensing and relaxing, and advances to progressively more efficient tensing-relaxing and passive relaxation exercises. Sessions are employed that teach techniques and problem-solve barriers to the use of PMRT.
16043522|NCT02571439|Procedure|Surgical TAP block|surgeon administered TAP block
16043523|NCT02571439|Procedure|Conventional TAP block|Anesthesiologist administered TAP block
16043524|NCT02571439|Drug|0.5% ropivacaine|20ml of 0.5% ropivacaine is used to perform the TAP block
16043525|NCT02571426|Drug|Sevoflurane|anesthetic agent
16043526|NCT02571426|Drug|propofol|anesthetic agent
16043527|NCT02571413|Other|score before teaching|score the check-point of correct INCS usage before teaching
16043528|NCT02571413|Other|score immediately after teaching|score the check-point of correct INCS usage immediately after teaching
16043529|NCT02571413|Other|score 3 months after teaching|score the check-point of correct INCS usage 3 months after teaching
16043530|NCT02571400|Other|Continued use of opioid analgesics >90 days post-surgery|Exposure of interest: continued use of opioid analgesics >90 days post-surgery
16043531|NCT02571387|Behavioral|Mindfulness-based intervention|
16043532|NCT02571387|Behavioral|Sham meditation|
16043533|NCT02571374|Dietary Supplement|symbiotic group|this group received sachets of symbiotic
16043534|NCT02571374|Dietary Supplement|placebo group|this group received placebo
16043535|NCT02571361|Drug|Paracetamol (1g x 4)|Dose of 1 g given in 6 hour intervals the first 24 hours postoperatively
16043536|NCT02571361|Drug|Ibuprofen (400 mg x 4)|Dose of 400 mg given in 6 hour intervals the first 24 hours postoperatively
16043537|NCT02571361|Drug|Paracetamol (0,5 g x 4)|Dose of 0,5 g given in 6 hour intervals the first 24 hours postoperatively
16043538|NCT02571361|Drug|Ibuprofen (200 mg x 4)|Dose of 200 mg given in 6 hour intervals the first 24 hours postoperatively
16043539|NCT02571361|Drug|Placebo (x4)|Given in 6 hour intervals the first 24 hours postoperatively
16043540|NCT02571348|Procedure|micro-osteoperforation|micro-osteoperforation with mini implant at different interval
16043541|NCT02571335|Behavioral|Intensive Training|"Week 1: Ratio of continuous and interval training of 2:1. Entry point at day one with 20 min of continuous, physiologically defined heart rate controlled cycling at 50-60 rounds per minutes at 75% of HRpeak.
~Resistance training is performed with 70% of the subjective-felt 1-round maximum with three sets and 10-12 repetitions and three exercises for the upper and lower extremities.
~Week 2 Progression of endurance training: 4x5 minutes with 2 Minutes between each interval performed at 80% of HRmax Progression resistance training: 75% of the subjective-felt 1-round maximum with three sets and 8-10 repetitions and three exercises for the upper and lower extremities.
~Week 3 Same as week 2."
16043542|NCT02571335|Behavioral|Normal Training|The control intervention is the normal rehabilitation program of the Valens clinic.
16043543|NCT02571322|Device|HyperVibe Whole Body Vibration training device|Standing on the HyperVibe platform during WBV training will cause repetitive upward movements of platform to be felt by participant.Thus the participant will feel a whole body vibration, as the name of training implies. Each session will last approximately fifteen minutes.
16043544|NCT02571322|Other|Aerobic Exercise|Aerobic exercise session will last approximately thirty minutes. Starting training intensity will be specific to each participant based on his/her baseline fitness level.
16043545|NCT02571309|Device|Asthmatuner|Asthmatuner is an app for self-management of asthma.
16043546|NCT02571296|Drug|micronized progesterone|Oral
16043547|NCT02571296|Drug|Placebo|Oral
16043548|NCT02571283|Drug|Cocktail|Administered as a single dose injection.
16043549|NCT02571283|Drug|Exparel|Administered 20 minutes+ before additional medications.
16043550|NCT02571283|Drug|Marcaine|Administered 20 minutes or more after Exparel is administered.
16043551|NCT02571270|Other|Combined aerobic and resistance physical training program|
16043552|NCT02571257|Drug|Gemcabene|1-300 mg tablet, QD, 56 days
16043553|NCT02571257|Drug|Gemcabene|3-300 mg tablets, QD, 56 days
16043554|NCT02571257|Drug|Placebo|
16043555|NCT02571244|Behavioral|Motivational Interview plus text message|After discharge the experimental group has received extended care including a counseling session and text messages. The session provided basic information about smoking and successful quitting. The counselor has used motivational interview techniques to build coping skills with the goal of helping the participant build and implement a quit plan. The focus was to increase motivation to make quit attempt, including confidence building, medication use, and cessation planning. The session lasted approximately 30 minutes. Participants in the experimental arm were offered up to 30 text messages to help them to implement the quit plan discussed during the phone call. Patients motivated to quit in the next 30 days or those that had already quit have received 30 messages (2 per day) and patients unwilling to quit 16 (2 per day). The messages followed the self efficacy theory.
16043557|NCT02571218|Device|Substrate+mCPVA|The intervention in the experimental arm includes using a research software (investigational device) to map AF substrate and guide ablation.
16043558|NCT02571218|Device|mCPVA|The intervention in the active comparator arm includes using the commercially available EnSite Velocity mapping and ablation system for modified circumferential pulmonary vein ablation.
16043559|NCT02571205|Drug|Sustanon (testosterone)|Standard incremental regimen of Sustanon
16043560|NCT02571192|Drug|SHP626|single oral dose 50mg SHP626 with approximately 5.95 μCi RAD
16043561|NCT02571192|Radiation|5.95 μCi RAD|
16043562|NCT02571179|Drug|intranasal fentanyl 50 microg dose up to 250 microg|When contraction pain was ≥ 5/10 (numerical rating scale 0= no pain, 10= worst pain), the parturient was given a intranasal fentanyl 50 µg dose. After 15 minutes, if contraction pain was still ≥ 5/10, a second 50 µg intranasal dose was administered. Fentanyl was administered every 15 minute until contraction pain decreased to less than 5/10 or until the maximum fentanyl dose of 250 µg was administered.
16043563|NCT02571166|Biological|HSV529|Live, Replication-defective HSV-2 virus
16043564|NCT02571166|Drug|Valacyclovir|500 mg orally, once daily for 4 weeks
16043565|NCT02571153|Drug|Ketamine 0.4 mg/kg|Intravenous ketamine 0.4 mg/kg after induction of anesthesia
16043566|NCT02571153|Drug|Normal saline|Intravenous normal saline 0.9% 5 mL
16043567|NCT02571153|Drug|Ketamine 0.2 mg/kg|Intravenous ketamine 0.2 mg/kg after induction of anesthesia
16043568|NCT02571140|Drug|Teriparatide|subcutaneous standard injection
16043569|NCT02571140|Drug|Oral PTH (1-34)|Different optimization of API
16043570|NCT02571127|Drug|Hidra1|"Parameters: Vaginal health index (VHI) : The parameter of efficiency : a vaginal moisture ; Will Measured through the VHI : 1 = none / inflamed area ; 2 = no / NOT inflamed surface ; 3 = minimal, 4 = moderate and 5 = normal.
~Will be described through the Media and Standard Deviation or median and interquartile rank , as Minimum and Maximum.
~Scala: pH tape: It will be measured by its own value. Questionnaire: Sexual Function Index female (FSFI): internationally validated questionnaire with single answers for patient."
16043571|NCT02571114|Dietary Supplement|Saskatoon Berry Frozen Yogurt|Frozen yogurt containing a defined amount of powder prepared from Saskatoon berries (serving size = 25 g available carbohydrate)
16043572|NCT02571114|Dietary Supplement|Frozen Yogurt|Unflavoured frozen yogurt (serving size = 25 g available carbohydrate)
16043573|NCT02571114|Dietary Supplement|Control 1|White bread (serving size = 25 g available carbohydrate)
16043574|NCT02571114|Dietary Supplement|Control 2|White bread (serving size = 25 g available carbohydrate)
16043575|NCT02571101|Drug|CDFR0812-15/25mg|Contains chlomipramine HCl 15mg and sildenafil citrate 25mg.
16043576|NCT02571101|Drug|CDFR0812-15/50mg|Contains chlomipramine HCl 15mg and sildenafil citrate 50mg.
16043577|NCT02571101|Drug|Condencia|Contains chlomipramine HCl 15mg.
16043578|NCT02571101|Drug|CDFR0812-Placebo|Placebo tablet of CDFR0812.
16043579|NCT02571101|Drug|Condencia-Placebo|Placebo tablet of Condencia
16043580|NCT02571088|Other|Training Program|Each training session will last 45 min. Exercise will start by a 5-min warm-up cycling period, followed by 30 min of cycling at the power output (W) individually determined before and corresponding to the first lactate threshold corresponding approximately to 2.5 mmol/l . Then patients will cool down for 5 min. Finally, the training sessions will end by 5 min of light stretching. All training sessions will take place at the hospital and will be under the supervision of a physician. Heart rate, oxygen saturation and blood lactate concentrations will be regularly measured. Work rate will be adjusted according to the obtained results. As a safety procedure, blood lactate concentration must not exceed 4 mmol/L during the training sessions. A particular attention will be paid to the hydration of patients. Pain and fatigue will be evaluated everyday by the patients using (100 mm) visual analog scales.
16043581|NCT02571075|Other|Auricular acupuncture|The ear will be cleaned with alcohol prior to insertion of the needles. Five sterile, single-use, gold needles will be placed in each ear according to the figure below. The needles penetrate about a millimeter (or 4/100ths of an inch) into the skin.
16043582|NCT02571062|Drug|Fexinidazole|
16043583|NCT02571049|Drug|DFN-11|Sumatriptan 3 mg versus 6 mg
16043584|NCT02571036|Drug|DCC-2618|50 mg formulated tablets
16043585|NCT02571036|Drug|DCC-2618|10 mg and 50 mg formulated tablets
16043586|NCT02571023|Procedure|microscope surgery|
16043587|NCT02571023|Procedure|neuroendoscope surgery|
16043588|NCT02571010|Other|Standard Medical treatment|Standard treatment with drugs and usual rehabilitation
16043589|NCT02571010|Device|Vibrotactile stimulation|Rehabilitation by vibrotactile stimulation at medical center
16043590|NCT02571010|Device|Sham Stimulation with Vibradol device switched off|Sham Rehabilitation at medical center but with Vibradol device switched off
16043591|NCT02570997|Drug|CT1812|Doses will be escalated in the following sequence: 10mg, 30mg, 90mg, 180mg, 360mg, 650mg.
16043592|NCT02570997|Drug|Placebo|Matching placebo administered.
16043595|NCT02570971|Drug|Mannitol|
16043596|NCT02570958|Drug|Indocyanine Green|In the operating room ENB will be used to locate the targeted lung tumor. Once the tumor is located, the surgeon will advance a bronchoscope to the tumor, a needle will be passed through the bronchoscope, and the tumor will be injected with 100-150 micro liters of ICG solution at 0.125mg/mL concentration. The tumor is expected to fluoresce using the da Vinci Firefly robotic camera, giving off a bright green hue. Wedge resection of the fluorescent part of the lung will then be performed. The excised specimen will be sent for immediate pathologist analysis. If the tumor is found within the specimen, and the specimen margins are free of tumor cells, then the procedure will be completed. If the tumor cannot be targeted or visualized, or if the tumor is not found in the pathological specimen, or if the margins of the specimen contain tumor cells, then a formal anatomical lobectomy or segmental resection of the lung will be performed to ensure that the tumor is completely excised.
16043597|NCT02570945|Procedure|Pharmacist-physician intervention to reduce high-risk medication use by elderly inpatients|
16043684|NCT02570451|Other|Confusion Assessment Method (CAM)|This well-validated measure of post-operative delirium will be utilized up to 3 days after surgery
16043598|NCT02570932|Biological|Autologous Mesenchymal Bone Marrow Cell|"Suspension in autologous plasma cell of Adult mesenchymal stem cells expanded autologous bone marrow.
~Route of administration: Intrathecal in subarachnoid space by lumbar puncture.Total dose of 300 x 106 CME, divided in 3 injections of 100 x 106 CME, with intervals of three months between each administration"
16043599|NCT02570919|Radiation|IGRT 45 Gy in 5 fractions of 9 Gy|Administration of 9 Gy in five consecutive days, to a total dose of 45 Gy radiation
16043600|NCT02570919|Radiation|IGRT 24 Gy single dose|Administration of a single dose of 24 Gy in one session
16043601|NCT02570906|Device|Zephyr BioPatch|Remote patient monitoring devices: BioPatch™ (ZephyrLIFE Hospital System™)
16043602|NCT02570893|Radiation|Adjuvant radiotherapy|Adjuvant radiotherapy (50.4gray/28fraction) followed by 4 cycles of chemotherapy (Paclitaxel and carboplatin) after radical esophagectomy.
16043603|NCT02570893|Radiation|Adjuvant radiotherapy|adjuvant radiotherapy (50.4gray/28fraction) only after radical esophagectomy.
16043604|NCT02570893|Drug|Paclitaxel and carboplatin|
16043605|NCT02570880|Other|glycemic index (glucose-solution, bread samples)|All participants will test 2 breads, prepared with different fermentation times of dough, both breads will be tested in duplicate. Methode: International Organization for Standardization / Final Draft International Standard 26642, Food products - Determination of the glycaemic index (GI) and recommendation for food classification
16043606|NCT02570854|Biological|CSJ137|Starting dose is 0.010 mg/kg and dose escalation will proceed with semi-log increase steps to a maximum dose level 10 mg/kg. Subjects receive the treatment via up to 30 minutes intravenous infusion.
16043607|NCT02570854|Drug|Placebo|Subjects will be dosed with a matching placebo (vehicle control) via up to 30 minutes intravenous infusion.
16043608|NCT02570841|Drug|Topical High dose Capsaicin|Topical High dose Capsaicin exposure within an area of 3x3 cm for 60 minutes
16043609|NCT02570841|Drug|Topical Placebo|Placebo exposure within an area of 3x3 cm for 60 minutes
16043610|NCT02570828|Device|Thermal Imaging|FLIR ONE attachment to an iPhone
16043611|NCT02570815|Drug|indocyanine green|ICG will be prepared as a sterile solution (2.5 mg/10mL) for injection. After vascular ligation, a 6 to 8mL bolus of ICG solution will be injected into the peripheral vein catheter, followed by a 10mL saline solution bolus. The Firefly camera will then be used for the NIF imaging. It is expected that the entire lung, except the segment which was previously isolated from blood supply, will fluoresce within 30-40 seconds, exhibiting a green hue. The surgeon will perform the pulmonary resection and the resected 'dark' lung segment will be immediately evaluated by a pathologist, depending on the pathologist findings the operation may be concluded or the patient will receive a pulmonary lobectomy.
16043612|NCT02570802|Procedure|Ultrasonographic examination|
16043613|NCT02570789|Drug|patients with sunitinib or pazopanib|The treatment with sunitinib or pazopanib should comply with the recommendations written in the Belgian product information and the reimbursement criteria
16043614|NCT02570763|Device|Active tDCS stimulation|
16043615|NCT02570763|Device|Sham tDCS stimulation|
16043616|NCT02570750|Behavioral|QUESTIONNAIRE ON SMOKING HABITS|"Data on smoking will include the age at which cigarette smoking began and ceased and the average amount smoked daily. Intensity (number of cigarettes smoked per day), duration of smoking (years), and time since cessation (years) will be categorized. Also, the smoking status of the patient prior psoriasis diagnosis will be assessed (smoker or non-smoker and years of smoking prior to psoriasis diagnosis).
~Smoking habit evaluation: baseline and changes in smoking habit at 12 and 24-weeks follow-up time points."
16043617|NCT02570724|Drug|"injection of HES  Voluven® "|Injection into the epidural space of 15 to 30 ml Voluven ® at a rate of 1 ml / about 5 seconds.
16043618|NCT02570724|Biological|blood patch|
16043619|NCT02570711|Drug|ACP-196|ACP-196 capsule
16043620|NCT02570711|Drug|Nab-paclitaxel|Nab-paclitaxel infusion
16043621|NCT02570711|Drug|Gemcitabine|Gemcitabine infusion
16043622|NCT02570685|Behavioral|Reflective Interpersonal Gratitude|Participants were given the following instructions in their journal: Writing is a great way to reflect on your daily events, helping to look back and focus on the good things in our lives. There are many things in our lives, big and small, which we might be grateful for. For the next three weeks, 3 times a week (9 days in total), reflect back on your day and think of the people you met and interacted with and are grateful for. Please write down in the space provided a number of positive social interactions over the day or friendships/relationships you are grateful for…..
16043623|NCT02570685|Behavioral|Reflective-Behavioral Gratitude|"Participants were given the following identical instructions as the reflective journal in addition to this At the end of each week, express this gratitude to a friend of your choice face-to-face or through e-mail, facebook, a kind note, tell him/her how much you appreciate something specific that he/she does and reflect on how your friend's reaction and how you feel."
16043624|NCT02570685|Behavioral|Neutral Control Journal|Writing is a great way to reflect on your daily events, helping to look back and reflect on our lives. For the next three weeks, 3 times a week (9 days in total), please write in the spaces provided things that happened during the day.
16043625|NCT02570672|Drug|Metformin|Subjects will be randomized to metformin titrated to 1000mg twice daily as tolerated.
16043626|NCT02570672|Drug|Placebo|Subjects will randomized to placebo will receive placebo
16043627|NCT02570659|Behavioral|Information Video|A 14 minutes intervention video explaining the mechanism of the injury from cross-professional point of view and physiotherapeutic advise
16043628|NCT02570646|Behavioral|QA-DDS|QuitAdvisorDDS is a point-of-care software tool to facilitate implementation of evidence-based tobacco treatment interventions in dental care settings.
16043629|NCT02570633|Other|Extract of ginger|Migraine patients (both genders) will receive capsules of 200 mg of ginger extract (5% gingerols) to be taken three times a day for 12 weeks.
16043630|NCT02570633|Other|Cellulose|Migraine patients (both genders) will receive capsules of 200 mg of placebo (cellulose) to be taken three times a day for 12 weeks.
16043631|NCT02570620|Device|Ultrasonography of the cervix|
16043632|NCT02570607|Biological|BNP dosage|
16043633|NCT02570594|Other|questionary|
16043685|NCT02570451|Other|RAND 36-Item Short Form Health Survey|This measure is a generic, coherent, and easily administered health survey used to assess self-reported quality of life
16043686|NCT02570451|Other|Grip Strength|Measured using the JAMAR dynamometer
16043634|NCT02570581|Other|Jelly with:Paracetamol|"A single dose of each drug will be opened (Paracetamol capsule) or crushed (tablets) in 100 ml of jelly (intervention 1-10) and in 100 ml of apple compote A mix of 6 drugs will be added to 100 ml of jelly (intervention 11) and in 100 ml of apple compote A negative control will consists in 100 ml of plain jelly or apple compote Each participant will receive 24 small transparent plastic glasses (verrines) randomly allocated from number 1 to number 24, each verrine containing 5 ml of the initial 100 ml drug preparation. The participant will be blind to the verrine content.
~The participant will taste the verrine content with a 1 ml spoon and spit out each spoonful et rinse his or her mouth with plain water (Evian) between two tests.
~The participant will score each verrine numbered 1-24 with a mark ranging from 0 to 10 on the results scoring sheet.
~Unblinding will take place immediately after the end of the test. Every volunteer will propose alternative solutions."
16043635|NCT02570581|Other|Jelly with Furosemide|
16043636|NCT02570581|Other|Jelly with Levothyroxine sodium salt|
16043637|NCT02570581|Other|Jelly with Memantine|
16043638|NCT02570581|Other|Jelly with Zopiclone|
16043639|NCT02570581|Other|Jelly with Alprazolam|
16043640|NCT02570581|Other|Jelly with Oxazepam|
16043641|NCT02570581|Other|Jelly with Donepezil|
16043642|NCT02570581|Other|Jelly with Clopidogrel|
16043643|NCT02570581|Other|Jelly with Ramipril|
16043644|NCT02570581|Other|Jelly with Paracetamol + Furosemide + Levothyroxine sodium salt + Memantine + Zopiclone + Alprazolam|
16043645|NCT02570581|Other|Plain jelly control|
16043646|NCT02570581|Other|Apple compote Paracetamol|
16043647|NCT02570581|Other|Apple compote Furosemide|
16043648|NCT02570581|Other|Apple compote Levothyroxine sodium salt|
16043649|NCT02570581|Other|Apple compote Memantine|
16043650|NCT02570581|Other|Apple compote Zopiclone|
16043651|NCT02570581|Other|Apple compote Alprazolam|
16043652|NCT02570581|Other|Apple compote Oxazepam|
16043653|NCT02570581|Other|Apple compote Donepezil|
16043654|NCT02570581|Other|Apple compote Clopidogrel|
16043655|NCT02570581|Other|Apple compote Ramipril|
16043656|NCT02570581|Other|Apple compote + Paracetamol + Furosemide + Levothyroxine sodium salt + Memantine + Zopiclone + Alprazolam|
16043657|NCT02570581|Other|Plain apple compote control|
16043658|NCT02570568|Device|Veinlite|Veinlite is a device that emits red light. It provides a non-invasive technique of inserting intra-venous cannula. Placing it onto the skin will cause the outlines of the veins to show up.
16043659|NCT02570568|Device|Pen-torch Transillumination|Pen-torch Transillumination is a non-invasive technique that utilizes 2 pen-torches to provide illumination.The tips of the pen torches are pressed onto the skin, causing the silhouette of the vein to show up
16043660|NCT02570568|Procedure|Conventional Venepuncture|This involves the conventional method of identifying veins suitable for venepuncture, which involves visualization and palpation.
16043661|NCT02570542|Procedure|leukapheresis|
16043662|NCT02570542|Drug|Plerixafor|Following enrollment, patients will be CD34+ stem cell mobilized at the discretion of the treating attending physician with the plerixafor for a maximum of 4 apheresis days, for the achievement of ≥ 7 x106 CD34+ cells/kg.
16043663|NCT02570542|Drug|carmustine, etoposide, cytarabine, melphalan|Carmustine 300 mg/m2 day -6 Etoposide 100 mg/m2 q12hrs x 8 doses day - 5 thru day -2 Cytarabine 100 mg/m2 q12hrs x 8 doses day - 5 thru day -2 Melphalan 140 mg/m2 day -1 BEAM dosages may be adjusted per institutional dose adjustments based on body weight.
16043664|NCT02570542|Procedure|Autologous Stem Cell Transplantation|
16043665|NCT02570529|Drug|Albis®|The patients take Albis® 2T orally twice a day during the period between start day of concurrent chemoradiotherapy and 1 month after the treatment. During the period receiving radiation, the patient are prescribed the medication by the 2 weeks, and after radiation, they receive the 1 month's medication.
16043666|NCT02570529|Drug|Placebo|The patients take placebo 2T orally twice a day during the period between start day of concurrent chemoradiotherapy and 1 month after the treatment. During the period receiving radiation, the patient are prescribed the medication by the 2 weeks, and after radiation, they receive the 1 month's medication.
16043667|NCT02570516|Procedure|Colonoscopy|A double colonoscopy is performed in a back-to-back design using NBI chromoendoscopy then indigo carmine in each patient.
16043668|NCT02570503|Drug|Ropivacaine|Ropivacaine (5mg/ml)-50ml
16043669|NCT02570503|Drug|Ketorolac|ketorolac (30mg/ml)- 1 ml
16043670|NCT02570503|Drug|Clonidine|clonidine (0.1mg/ml)- 0.8ml
16043671|NCT02570503|Drug|Epinephrine|epinephrine (1mg/ml)-1ml
16043672|NCT02570503|Drug|0.9% sodium chloride|Sodium chloride 0.9%- 47.7 ml
16043673|NCT02570490|Drug|sodium fusidate|
16043674|NCT02570490|Drug|linezolid|
16043675|NCT02570477|Procedure|Fecal Microbiota Transplantation|Healthy donor is screened and donates feces. It will then be diluted with sterile saline, blended and filtered. Supernatant will be infused to recipient.
16043676|NCT02570477|Drug|Vancomycin|125mg Vancomycin four times per day
16043677|NCT02570464|Procedure|Remote ischemic preconditioning|Remote ischemic preconditioning is done for patients undergoing elective open infrarenal abdominal aortic aneurysm repair
16043678|NCT02570464|Biological|Blood drawn|Blood drawn is done for patients undergoing elective open infrarenal abdominal aortic aneurysm repair
16043679|NCT02570451|Other|Patient Survey|This survey will assess patients' perspective about the importance of preoperative cognitive screening, information about living situation, information about who accompanied them to the preoperative visit, and level of perceived stress.
16043680|NCT02570451|Other|Mini Cog|The MiniCog is a simple cognitive screening tool that takes just 2-4 min to complete and has little or no education, language, or race bias. This is a well-validated tool to assess mild cognitive impairment.
16043681|NCT02570451|Other|Independent Activities of Daily Living Score Sheet|Questionnaire used to measure self-reported functional status for instrumental activities of daily living using standardized scales
16043682|NCT02570451|Other|Activities of Daily Living Score Sheet|Questionnaire used to measure self-reported functional status for basic activities of daily living using standardized scores
16043683|NCT02570451|Other|Geriatric Depression Scale Short Form|Questionnaire used to measure self-reported mood
16043741|NCT02570009|Behavioral|Need Support Training|
16043687|NCT02570425|Device|Training on BF Spiromax followed by SYMBICORT Turbohaler|Training with a placebo comparator: Budesonide Formoterol (BF) Spiromax® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
16043688|NCT02570425|Device|Training on SYMBICORT Turbohaler followed by BF Spiromax|Training with a placebo comparator: SYMBICORT Turbohaler® device using a 6-level system to examine the number of levels required to acquire mastery of device at baseline and maintenance and mastery at 4 and 8 weeks after initial training.
16043689|NCT02570412|Drug|aldoxorubicin|aldoxorubicin administered at 350 mg/m2
16043690|NCT02570399|Radiation|Oligometastatic patients with abdominal-pelvic lymph nodes|Hypofractionated ablative radiation therapy for oligometastatic patients with lymph node metastases
16043691|NCT02570386|Procedure|Fresh embryo transfer|Women allocated to the control arm will either undergo embryo transfer at cleavage stage or extended culture and transfer at blastocyst stage according to local policy. A maximum of 2 embryos or blastocysts will be replaced according to the standard protocol under transabdominal ultrasound guidance. Luteal phase support is given according to local protocols.
16043692|NCT02570386|Procedure|Frozen embryo transfer|Fresh embryo transfer will not be undertaken. Embryos will be frozen by vitrification or slow freezing at cleavage or blastocyst stage according to standard agreed local protocols. Women will be contacted after 4 weeks and arrangements made for frozen embryo transfer.
16043693|NCT02570373|Drug|Guselkumab|Participant will receive a single intravenous (IV) infusion of guselkumab at a dose of 10 milligram per kilogram (mg/kg) over 60 minutes on Day 1.
16043694|NCT02570360|Behavioral|exercise|The EX participants will engage in supervised, individual treadmill exercise 3xs/wk at the UW Natatorium. Sessions will consist of a 5-minute warm-up followed by 30 minutes of a moderate to moderately-high intensity exercise and then finish with a 5-minute cool down. Questionnaires will be completed before and after exercise on a weekly basis.
16043695|NCT02570360|Behavioral|treatment-as-usual|The control (standard care) participants will come to the UW-Natatorium on a weekly basis to complete questionnaires.
16043696|NCT02570347|Drug|Co-amoxiclav|Injection Co-amoxiclav 1.2 g intravenously q8h for a minimum of 48-72 hours; switched to oral Co-amoxiclav 625 mg b.i.d. when clinically appropriate.
16043697|NCT02570347|Biological|Tetanus toxoid|Injection Tetanus toxoid 0.5 ml intramuscularly Stat
16043698|NCT02570334|Other|HIV-infected children initiated antiretroviral treatment within the first 7 months of life|All arms will recieve a thourough clinical evaluation : Global motor development (Touwen test), global cognitive development (K-ABC II test), visual (Log Mar Char) and hearing (full ear nose and throat examination) impediments as well as a questionnaire concerning socioeconomic situation, medical history of the child and mother, and HIV treatment and follow up information.
16043699|NCT02570321|Procedure|Bacterial ulcer cross-linking|For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis.
16043700|NCT02570321|Procedure|Bacterial ulcer control|For those bacterial ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for bacterial ulcers. This group will have their eyes irrigated with a balanced salt solution.
16043701|NCT02570321|Procedure|Fungal ulcer cross-linking|"Prior to receiving cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
~For those subjects randomized to receive collagen cross-linking, the procedure will be performed as per the routine at the hospital (UV-X machine; strict aseptic precautions; corneal epithelium debrided and 0.1% riboflavin applied for 30 minutes, then UV-A radiation applied for 30 minutes at 370nm with 3mW/cm2). Corneal cross-linking is a routine procedure performed by Aravind Eye Hospital for infectious keratitis."
16043702|NCT02570321|Procedure|Fungal ulcer control|"Prior to receiving sham cross-linking, topical amphotericin B or topical natamycin antifungal therapy will be started as per routine at the hospital; a loading dose of amphotericin B or natamycin every 5 minutes x 6 will be followed by dosing every 30 minutes. Amphotericin B and natamycin are routinely used therapies for fungal keratitis at Aravind Eye Hospital.
~For those fungal ulcer subjects randomized to the control group, they will receive the standard of care topical treatment for fungal ulcers. This group will have their eyes irrigated with a balanced salt solution."
16043703|NCT02570308|Drug|IMCgp100|Bispecific soluble HLA-A2 restricted gp100-specific T-cell receptor fused to anti-CD3
16043704|NCT02570295|Other|Swiss Army Physical Fitness Training|2 x 90 minutes strength training and sport games and 2 x 30 minutes endurance training per week during 18 weeks of basic military training
16043705|NCT02570282|Drug|Placebo|Approximately 50% of the cream is to be applied externally to the clitoris and labia minora and approximately 50% is to be applied intravaginally.
16043706|NCT02570282|Drug|SST-6007|SST-6007 is a white to off-white cream containing 5% (w/w) sildenafil citrate
16043707|NCT02570269|Procedure|AuraGain|Fiberoptic Intubation
16043708|NCT02570269|Procedure|Slotted Guedeltubus|Fiberoptic Intubation
16043709|NCT02570256|Behavioral|Deficit-fields to reduce error|Stroke survivors exhibit error in both reaching extent and abnormal curvatures of motion. Prior error augmentation techniques multiply error by a constant at each instant during movement. However, magnification of spurious errors may provoke over-compensation. We hypothesize that a deficit-field design, using the statistics of a patient's errors to customize training, will provide optimal augmentation that varies during motion as needed. We will compare the training effects of error deficit-fields with previous methods of error augmentation to improve reaching ability.
16043742|NCT02569996|Drug|Rituximab|Rituximab will be administered at 375 mg/m^2 every 8 weeks for 24 months or until progression, relapse, death, or institution of a new anti-lymphoma treatment.
16043743|NCT02569983|Other|Observational cohort|No intervention - observational study
16043793|NCT02569671|Device|Straumann Bone Level Tapered Implant - Delayed Placement|Delayed placement of a Straumann Bone Level Tapered Dental Implant for replacement of a singe tooth.
16043794|NCT02569658|Drug|Tranexamic Acid|
16043710|NCT02570256|Behavioral|Deficit-fields to expand range of motion|Motor deficits manifest in the workspace limitations of joints, i.e. reduced range of motion, uneven extension-flexion, inter-joint coupling, and unwanted synergies. Our work builds upon these ideas by augmenting self-directed movement for training coordination. We found that amplifying augmentation can expand motor exploration and improve skill retention in patients. Using motor exploration patterns from each patient, we will form customized deficit-fields to recover normal joint workspace. We will compare augmentation training that either amplifies or diminishes the observed deficits (Expt-1). We also compare deficit-fields with our prior augmentation methods to determine the added value of increased customization (Expt-2).
16043711|NCT02570256|Behavioral|Deficit-fields to improve function|Clinicians have recognized the benefits of training on everyday tasks (Hubbard, Parsons et al. 2009), as well as practice with whole-body actions (Boehme 1988; Bohannon 1995). However, typical robotic systems have only a single contact point and cannot drive the multiple joints involved in functional tasks. Visual distortions (e.g. a shift, rotation or stretch) can promote adaptation even without forces. Here we present visual distortion of whole body movement during manual tasks during standing, including reaching, grasping, and object manipulation. We compare the training effects of feedback based on deficit-fields versus practice with normal vision.
16043712|NCT02570243|Drug|High dose of Unfractionated Heparin|Unfractionated Heparin 100IU/Kg
16043713|NCT02570243|Drug|Standard dose of Unfractionated heparin|Unfractionated heparin 50IU/Kg
16043714|NCT02570230|Other|NSS|NSS infusion
16043715|NCT02570230|Drug|Ketamine|Ketamine 0.2 mg/kg/hr intravenous infusion
16043716|NCT02570217|Device|HHHFNC|infants receive non-invasive respiratory support by mean of HHHFNC
16043717|NCT02570217|Device|NCPAP|infants receive non-invasive respiratory support by mean of NCPAP
16043718|NCT02570204|Behavioral|Self-assessment|Patients enrolled into the study will do a multi-level pregnancy test (MLPT) at enrollment, and will receive one MLPT to do at home one week after taking mifepristone and misoprostol. They will be instructed to call the study site if the at-home MLPT result do not decline, or if they experience any abortion complications.
16043719|NCT02570191|Drug|Peginterferon alfa-2a|180 uG in 0.5 mL solution administered once weekly for 48 weeks
16043720|NCT02570178|Other|balance training|Participants complete 2 sessions per week for 30 minutes each, over a period of three months and are distributed in groups of four individuals carrying out the exercises at once.The groups were led by monitors who had received standardized training. Each participant was barefoot on the balance board, carrying out the different exercises in the balance area of the Wii Fit™ game, according to the indications made on the screen.Eight out of the nine balance exercises were used from the Wii Fit™ game (balance bubble, soccer heading, ski jump, table tilt, ski slalom, penguin slide, snowboard slalom, tightrope walk);.The number of repetitions of each exercise varied depending on the skill of the participants but the total time dedicated to each exercise was the same for all group participants.
16043721|NCT02570165|Drug|Batefenterol|Batefenterol will be provided as dry white powder for inhalation via a DPI with 30 doses (2 strips with 30 blisters per strip). First strip will contain lactose and the second strip will contain batefenterol blended with lactose with a unit dose strength of 37.5 mcg, 75 mcg, 150 mcg, 300 mcg, or 600 mcg per blister
16043722|NCT02570165|Drug|Umeclidinium/ Vilanterol|Umeclidinium/Vilanterol will be provided as dry white powder for inhalation via a DPI with 30 doses (2 strips with 30 blisters per strip). First strip will contain umeclidinium blended with lactose and magnesium stearate with a unit dose strength of 62.5 mcg per blister and the second strip will contain vilanterol blended with lactose and magnesium stearate with a unit dose strength of 25 mcg per blister
16043723|NCT02570165|Drug|Placebo|Placebo will be provided as dry white powder for inhalation via a DPI with 30 doses (2 strips with 30 blisters per strip) containing lactose
16043724|NCT02570152|Procedure|Blood sample collection|Blood samples will be collected during the Suspected Dengue First Visit. All study subjects with AFI (fever [body temperature ≥ 38°C/≥ 100.4°F] on ≥ 2 consecutive calendar days, measured at least twice, at least 8 hours apart) should be seen at a designated study hospital/clinic by the study physician. The Suspected Dengue First Visit should be scheduled within 7 days from the onset of fever (Days 2-7) and should ideally take place on the second day of fever (Day 2).
16043725|NCT02570139|Device|Cavilon Advanced Skin Protectant|The liquid barrier film flows from the applicator and dries quickly on the skin. It is durable for 72-96 hours under conditions of incontinence.
16043726|NCT02570139|Device|ConvaTec Sensi-Care Protective Barrier|Sensi-Care is commercial paste product applied to protect denuded and weeping skin from incontinence.
16043727|NCT02570126|Biological|Varilrix HSA-free|2 doses will be administered, one at Day 0 and the other at Day 42
16043728|NCT02570126|Biological|Varilrix™|2 doses will be administered, one at Day 0 and the other at Day 42
16043729|NCT02570113|Device|Peregrine System Infusion Catheter|The Peregrine Catheter is inserted bilaterally into the renal arteries and a specified amount of a neurolytic agent is inserted into the vessel walls.
16043731|NCT02570087|Procedure|chronic total coronary occlusion percutaneous intervention|Percutaneous intervention of chronic total coronary occlusion with stent implantation
16043732|NCT02570074|Drug|Fosfomycin|Broad spectrum antibiotic
16043733|NCT02570061|Behavioral|telephone|information given at the primary contact by phone, or at a scheduled later time
16043734|NCT02570061|Behavioral|consultation face-to-face|information given at a scheduled consultation at the hospital
16043735|NCT02570048|Device|Mutebutton intervention|Participants are asked to use the MuteButton daily for 30-40 minutes.They receive 'pink noise' through headphones and transcutaneous stimulation on the tongue using a 'lollypop' sensor that sits on the anterior section (tip) of the tongue.
16043736|NCT02570035|Drug|Mirabegron|oral
16043737|NCT02570022|Drug|Liposomal bupivacaine|Local infiltration of liposomal bupivacaine
16043738|NCT02570022|Procedure|Inter-scalene nerve block|Pre-operative inter-scalene nerve block
16043739|NCT02570022|Drug|Ropivacaine|Ropivicaine was used for the inter-scalene nerve block.
16043740|NCT02570009|Behavioral|TEAMS (Talking about Eating, Activity, Mutual Support)|
16043744|NCT02569970|Drug|fluoxetine 20 mg|"Fluoxetine 20 mg per day during 4 weeks prior to video-EEG, then continued during video-EEG.
~At the end of video-EEG, and according to patient's decision, treatment was either progressively withdrawn (1 week at 10 mg per day and then 1 week at 5 mg per day), or replaced by fluoxetine 20 mg open-label."
16043745|NCT02569970|Drug|placebo 20 mg|"Placebo 20 mg per day during 4 weeks prior to video-EEG, then continued during video-EEG.
~At the end of video-EEG, and according to patient's decision, treatment was either progressively withdrawn (1 week at 10 mg per day and then 1 week at 5 mg per day), or replaced by fluoxetine 20 mg open-label."
16043746|NCT02569957|Drug|Topotecan Hydrochloride|Given IV
16043747|NCT02569957|Drug|Topotecan Hydrochloride|Given IV
16043748|NCT02569957|Drug|Acetylcysteine|Given IV and PO
16043749|NCT02569944|Procedure|Bladder stimulation|"Patients included in this arm were stimulated to collect urine with bladder stimulation technique. This technique consists in a tapping movement in the suprapubic area, followed by a circular massage in sacral zone. This sequence lasts one minute and it is repeated five times.
~No other procedure, drug or device was done/used in this patients."
16043750|NCT02569944|Procedure|Perineal bag|Patients included in this arm were placed a perineal bag to collect urine sample. No other procedure, drug or device was done/used in this patients.
16043751|NCT02569931|Other|Gait analysis|Participants will be asked to walk on an instrumented treadmill. The study group will undergo gait analysis before surgery and 6 months after surgery. The control group will undergo gait analysis at one visit only.
16043752|NCT02569931|Other|Electromyography|Participants in the study group will undergo electromyography before and 6 months after surgery. Participants in the control group will undergo electromyography at one visit only
16043753|NCT02569931|Procedure|Intra-operative tracking and pressure measurements|Participants in the study group will undergo intra-operative tracking and pressure measurements to see if corrective surgery to stabilise the patella improves tracking and pressure measurements
16043754|NCT02569918|Device|Surface electrical stimulation|"Surface electrical stimulation using the following experimental devices. 1) The CE-approved HASOMED electrical isolated stimulator (Rehastim). 2) Two hand prosthesis: the robotic hand Azzurra (Prensilia, Italy) and the robotic hand Multi-sensory Prosthetic Hand (Wessling robotics, Germany) 3) The EPIONE Psychophysical Testing Platform software for stimulator control. Surface stimulation therapy is provided while providing visual guidance to the subject."
16043755|NCT02569905|Drug|parecoxib sodium|parecoxib sodium 40mg
16043756|NCT02569905|Drug|flurbiprofen|flurbiprofen 50mg
16043757|NCT02569905|Drug|saline|normal saline
16043759|NCT02569879|Other|Pertussis maternal immunization|Retrospective time trend analysis before and after pertussis maternal immunization in Bogota, Colombia.
16043760|NCT02569866|Drug|Cephalexin|Capsules containing cephalexin/500mg
16043761|NCT02569866|Drug|Placebo|Capsules containing placebo/500mg
16043762|NCT02569853|Drug|DFN-11|
16043763|NCT02569853|Other|Placebo|
16043764|NCT02569840|Dietary Supplement|Amino Acid Feed|Each child will receive the amino acid based feed for a period of up to 4 weeks (28 days). The feed prescription will be determined on an individual basis by the Dietitian responsible for the child's nutritional management. The child will take the feed orally or via a pre-existing naso-gastric, gastrostomy or jejunostomy tube.
16043765|NCT02569827|Drug|Celgosivir|Celgosivir 150 mg Q6H for 5 days (total of 20 doses = 3000 mg celgosivir total).
16043766|NCT02569827|Drug|Modipafant 50mg|Modipafant 50 mg Q12H alternating with placebo Q12H for 5 days (total of 10 modipafant doses = 500 mg modipafant)
16043767|NCT02569827|Drug|Placebo|Placebo Q6H for 5 days
16043768|NCT02569827|Drug|Modipafant 100mg|Modipafant 100 mg Q12H alternating with placebo Q12H for 5 days (total of modipafant 10 doses = 1000 mg modipafant)
16043769|NCT02569814|Drug|Fimasartan/Amlodipine/Rosuvastatin|
16043770|NCT02569814|Drug|Fimasartan/Amlodipine|
16043771|NCT02569814|Drug|Rosuvastatin|
16043772|NCT02569801|Drug|Fulvestrant|Fulvestrant at a dose of 500 mg as two intramuscular injections will be administered on Day 1 and Day 15 of Cycle 1, and on Day 1 of each subsequent 28-day cycle.
16043773|NCT02569801|Drug|GDC-0810|GDC-0810 will be administered as tablets at a dose of 600 mg orally once daily.
16043774|NCT02569788|Radiation|Carbon ion radiotherapy (CIRT)|Five dose levels (55GyE, 57.5GyE, 60GyE, 62.5GyE, 65GyE) are planned within the Phase I part. Daily fraction of 2.5 GyE will be delivered for all dose levels. After the recommended dose (RD), i.e., MTD, is determined or if the treatments to 65 GyE are safely delivered, the recommended dose (or 65 GyE) will be the prescribed dose in the Phase II part of the study. Ninty-five percent (95%) of the isodose line should cover the GTV+3~5mm.
16043775|NCT02569775|Biological|Autologous Bone Marrow Mononuclear Cells|Transplantation of Autologous Bone Marrow Mononuclear Cells
16043776|NCT02569762|Dietary Supplement|Sucralose-Aspartame|Sucralose or aspartame
16043777|NCT02569762|Dietary Supplement|Aspartame-Sucralose|Aspartame or sucralose
16043778|NCT02569749|Other|Berlin and Epworth questionaries|
16043779|NCT02569749|Other|Sleep apnea monitoring in those patients in whom a pacemaker with monitoring apnea system has been implanted.|
16043780|NCT02569749|Other|Night polygraph / Polysomnography|
16043781|NCT02569723|Drug|Carbon C 14 Oxaliplatin|Intravenous infusion
16043782|NCT02569723|Drug|Oxaliplatin|Intravenous infusion
16043783|NCT02569710|Drug|AL-335|AL-335 tablets will be administered in a dose range of 400 to 1200 mg once daily (QD).
16043784|NCT02569710|Drug|Odalasvir (ODV)|ODV capsules will be administered in a dose range of 25 to 50 mg.
16043785|NCT02569710|Drug|Simeprevir (SMV)|SMV tablets will be administered in a dose range of 75 to 150 mg QD or every other day (QOD).
16043786|NCT02569697|Other|HEC Placebo gel|
16043787|NCT02569697|Other|Placebo Intravaginal Ring|
16043788|NCT02569697|Other|Placebo Vaginal Film|
16043789|NCT02569697|Other|Placebo Vaginal Insert|
16043790|NCT02569684|Dietary Supplement|Prebiotic fibers: oligofructose and inulin|
16043791|NCT02569684|Dietary Supplement|Maltodextrin|
16043792|NCT02569671|Device|Straumann Bone Level Tapered Implant - Immediate Placement|Immediate placement of a Straumann Bone Level Tapered Dental Implant for replacement of a singe tooth.
16043796|NCT02569645|Drug|Rosuvastatin|40 mg rosuvastatin orally once per day with or without food, swallowed whole (not chewed, crushed or divided) starting 2 weeks prior to the initiation of radiation therapy and stopped at 4 weeks after the completion of radiation. Total duration of Rosuvastatin is 11 weeks if 25 fractions of radiotherapy are given, or 12 weeks if 30 fractions of radiotherapy are given.
16043797|NCT02569632|Biological|Trumenba Vaccine (Wyeth/Pfizer Pharmaceuticals)|All subjects will receive three doses of a Trumenba, a U.S.-licensed meningococcal vaccine. Each 0.5 mL dose contains 60 micrograms of each FHbp variant (total of 120 micrograms of protein), 0.018 mg of PS80 and 0.25 mg of Al³+ as AlPO4 in 10 mM histidine buffered saline at pH 6.0. Trumenba is administered as a three dose series (0.5 mL each) according to a 0-, 2-, and 6-month schedule.
16043798|NCT02569619|Behavioral|Activity Intervention|
16043799|NCT02569619|Behavioral|Healthy Diet Intervention|
16043800|NCT02569593|Dietary Supplement|Iron supplements, more specific Ferrodyn and Vista Ferrum|Ferrodyn is an Fe-chelate supplement. One tablet contains 28 mg elemental iron. Vista Ferrum is an iron(II)sulfate supplement. One tablet also contains 28 mg elemental iron. The volunteers will be asked to take the provided supplement orally with 150 mL of water.
16043801|NCT02569580|Device|Topically|"use the No More medical device as anti lice treatment"
16043802|NCT02569567|Procedure|Smart-Shear Wave(SSW) imaging|"All Smart-Shear Wave(SSW) imaging examinations will be performed by one operator.
~The right lobe of the liver is examined through the intercostal view with the patient lying in a supine or semi-decubitus position with the right arm in maximal abduction.
~Once the optimal sizes of the regions of interest is chosen, they are fixed for subsequent measurement in each subject. Special attention is paid to avoid any focal lesion, vessels, biliary tracts, or artifacts from nearby lung gas or cardiac movement."
16043803|NCT02569567|Procedure|Transient elastography(TE)|"Using the M probe in patients with BMI <30 kg/m2.
~Liver measurement is taken at either the seventh or eighth intercostal space of each subject over the right lobe of the liver. The measuring depth ranges from 2.5 to 6.5 cm below the skin surface.
~Examinations are performed by a sonographer blinded to S-shear wave elastography, and biological results."
16043804|NCT02569554|Drug|PF-06463922|each subject will receive 4 single oral doses of 100 mg PF-06463922 (treatment A: tablets without food; treatment B: tablets with food; treatment C: tablets without food with rabeprazole; treatment D: oral solution without food). There will be at least 10 days washout period between consecutive PF-06463922 single dose.
16043805|NCT02569554|Drug|rabeprazole|20 mg daily tablets in the evening for 5 days and Pf-06463922 on the morning of day 6 in treatment C.
16043806|NCT02569541|Drug|sodium fusidate|
16043807|NCT02569515|Drug|Epoetin Beta|Initial dose: 3X30 IU/Kg body weight administered subcutaneously using RecoPen. Dosage could be increased by 3X20 IU/Kg every 4 weeks up to a maximum of 720 IU/Kg per week.
16043808|NCT02569502|Drug|enfuvirtide|Participants will receive a total daily dose of 180mg of enfurtide administered twice daily as a subcutaneous injection.
16043809|NCT02569489|Drug|HBI-8000|
16043810|NCT02569489|Drug|Trastuzumab|
16043811|NCT02569489|Drug|Paclitaxel|
16043812|NCT02569476|Drug|BGB-3111 and Obinutuzumab|
16043813|NCT02569463|Drug|Interleukin-2|Recombinant Human Interleukin-2 (RhIL-2) was administered subcutaneously at a dose of 1 million IU every other day for 4 weeks.
16043814|NCT02569450|Behavioral|Surgical outcomes monitoring using Shewhart control chart|"Assistance by a local surgeon responsible for the implementation of intervention within his/her department
~Quarterly team meeting to interpret variations in observed outcomes on the control charts
~Restitution of surgical outcomes based on wall posters in operating room
~Training sessions provided to local surgeon for appropriate control chart utilization"
16043815|NCT02569437|Drug|Doxycycline|Doxycycline (200 mg PO X 1 dose on Day 1, then 100 mg PO daily) for Day 2-20
16043816|NCT02569437|Drug|methylprednisolone|oral methylprednisolone: 32 mg x 5 days, 16 mg x 5 days, 8 mg x 10 days
16043817|NCT02569437|Drug|nasal saline spray|nasal saline sprays: 2 sprays each nostril three times a day
16043818|NCT02569437|Drug|Flonase|daily nasal steroid sprays (Flonase, 2 sprays each nostril daily).
16043819|NCT02569437|Drug|sugar pill|placebo pill to match doxycycline
16043820|NCT02569424|Behavioral|Patient's position|Supine or Trendelenburg strict -20°)
16043821|NCT02569411|Other|Financial Incentive|money
16043822|NCT02569398|Drug|Atabecestat, 5 mg|One atabecestat, 5 mg tablet orally once daily up to 54 months.
16043823|NCT02569398|Drug|Atabecestat, 25 mg|One atabecestat, 25 mg tablet orally once daily up to 54 months.
16043824|NCT02569398|Drug|Placebo|One matching placebo tablet orally once daily up to 54 months.
16043825|NCT02569385|Other|Spontaneous breathing trial|
16043826|NCT02569372|Biological|GC1102|GC1102(Recombinant Hepatitis B Human Immunoglobulin)
16043827|NCT02569359|Dietary Supplement|shea nut oil extract|
16043828|NCT02569359|Other|Placebo|
16043829|NCT02569346|Drug|Triumeq|Single-dose Triumeq as a whole tablet
16043830|NCT02569346|Drug|Triumeq crushed + breakfast|Single-dose crushed and suspended tablet of Triumeq
16043831|NCT02569346|Drug|Triumeq crushed + drip feed|Drip feed followed by single-dose crushed and suspended tablet of Triumeq
16043832|NCT02569333|Other|Educational video|iPad with educational video highlighting current guidelines for the management of hospitalized patients with ulcerative colitis.
16043833|NCT02569320|Drug|Dexamethasone|Given PO
16043834|NCT02569320|Drug|HDAC Inhibitor AR-42|Given PO
16043835|NCT02569320|Other|Laboratory Biomarker Analysis|Correlative studies
16043836|NCT02569320|Drug|Pomalidomide|Given PO
16043837|NCT02569307|Drug|Minocycline|Minocycline added to TAU Minocycline will be administered in 200mg once daily dose
16043838|NCT02569307|Drug|Omega-3 fatty acids|Omega-3 fatty acids added to TAU Omega-3 fatty acids will be administered in 1.2g once daily dose
16043839|NCT02569307|Drug|Placebo|Placebo added to TAU
16043840|NCT02569307|Drug|Minocycline Plus Omega-3 fatty acids|Minocycline will be administered in 200mg once daily dose and Omega-3 fatty acid 1.2g taken as once daily dose
16043943|NCT02568514|Device|Secure text messaging|A smartphone and web application that allows physicians and other health care professionals to communicate to each other by secure text message
16043944|NCT02568501|Behavioral|Daily feedback|Daily feedback on glucose levels from wireless glucometers
16043841|NCT02569294|Behavioral|Yoga intervention|Hatha-yoga intervention included 6 weekly 90-min sessions in groups of 3 to 8 participants led by Hatha-yoga trained teachers. This program was developed previously in Montreal and the following were included at each session: 1) preparatory warm-up synchronized with breathing; 2) selected postures (e.g. forward , backward-, and side-bending asanas in sitting and lying positions); 3) deep relaxation; 4) alternate-nostril breathing or pranayama; and 5) meditation. Each participant received a DVD to encourage at-home practice.
16043842|NCT02569294|Behavioral|Hypnosis intervention|Hypnosis intervention included 6 sessions of 2 hours every 2 weeks. This was led by an anesthesist with experience in oncology and trained in hypnosis. Based on years of consultation with cancer patients, her team created a negotiating approach that fosters shared decision-making through using tasks that are centered on general well-being rather than on the health problem itself. Patients were asked to be actively involved. Several topics are addressed through tasks: eg. adjusting self-expectations. Patients were also required to keep a work-diary that was reviewed at the beginning of each session. At the end of the session, a 15-min hypnosis exercise is conducted. They receive CDs containing the hypnosis exercises and homework assignments.
16043843|NCT02569294|Behavioral|CBT intervention|CBT intervention included 6 weekly 90-min sessions in groups of 3 to 8 participants led by CBT-trained psychologists with experience in psycho-oncology. This program was developed by team leaders and is modelled on the work of Andersen et al. (2008) and Savard (2010). The intervention targets were: 1) breast cancer, meaning of illness, understanding stress and responses to it; 2) impact of treatment on body image; 3) impact of treatment on self-esteem; 4) fear of recurrence; 5) relationships with relatives and health professionals; and 6) life projects, return to daily activities and work. Relaxation training took place at the end of each session and participants performed tasks between sessions.
16043844|NCT02569281|Other|US-guided percutaneous electrolysis|US-guided percutaneous electrolysis consists of the application of a galvanic electrical current with an acupuncture needle in the soft tissue, in this case the supraspinatus tendon.
16043845|NCT02569281|Other|Eccentric exercise|An eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles will be learned by the patients allocated to this group
16043846|NCT02569268|Other|Questionnaires and follow-up|Detecting the vascular functional parameters, questionnaire and follow-up: For 2 years or the occurrence of vascular events end time, including cardiovascular events (acute myocardial infarction, angina, coronary reperfusion therapy), stroke, heart failure, peripheral vascular disease.
16043847|NCT02569255|Procedure|Pulmonary venous ostia isolation|Percutaneous, catheterbased, radiofrequency ablation with left atrial access via atrial septal puncture. Helped by 3D-imaging system (Carto(tm)) and electrical signal guidance the PV ostia together with neighbouring atrial tissue is electrically isolated from the rest of the left atrium.
16043848|NCT02569242|Drug|Nivolumab|
16043849|NCT02569242|Drug|Docetaxel/Paclitaxel|
16043850|NCT02569229|Other|Diagnostics for glucose tolerance with 3 different methods.|"A 7-day course of subcutaneous continuous glucose monitoring system (CGMS).
~An oral glucose tolerance test done within the 7 day period of CGMS.
~Optionally a intravenous glucose tolerance test done within the 7 day period of CGMS."
16043851|NCT02569216|Device|Electrical Inhibition (EI)|constant direct current 1-20mA transvaginal 10 second bursts only when needed
16043852|NCT02569203|Dietary Supplement|standard enteral nutrition|standard enteral nutrition
16043853|NCT02569203|Dietary Supplement|high-protein enteral nutrition of immune modulating nutrients enriched with β-glucan|high-protein enteral nutrition of immune modulating nutrients enriched with β-glucan
16043854|NCT02569203|Dietary Supplement|high-protein enteral nutrition of immune modulating nutrients without β-glucan|high-protein enteral nutrition of immune modulating nutrients without β-glucan
16043855|NCT02569190|Device|Walkbot|Robot assisted gait training
16043856|NCT02569151|Device|HBP & CBP measurement using systo 130 mmHg|
16043857|NCT02569138|Device|Modified Insole|hard and thin shoe insert between the foot sole and base of the footwear
16043858|NCT02569138|Device|Non-Modified Insole|regular shoe insert between the foot sole and base of the footwear
16043859|NCT02569125|Drug|Everolimus|4.5 mg/m² daily
16043860|NCT02569112|Device|multipolar RF, varipulse|Multi-polar Radio frequency (RF) technology combining pulsed electro magnetic fields (PEMF) and mild suction stimulation (varipulse).
16043861|NCT02569112|Device|cryolipolysis|Cryolipolysis technology uses the sensitivity of fat cells to cold injury, causing them to freeze and undergo cellular apoptosis.
16043862|NCT02569099|Other|Caregiver training|One hour training of family caregivers on the basic function of the brain and the stroke condition and its management in the home.
16043863|NCT02569086|Other|Blood draw|
16043864|NCT02569073|Drug|Dronabinol|Dronabinol 5 mg, every other night, orally
16043865|NCT02569073|Drug|Placebo|Placebo--no drug
16043866|NCT02569060|Other|Testing and Monitoring of Blood Glucose Levels|Point-of-care testing of HbA1c levels at the food pantry at approximately 3 month intervals
16043867|NCT02569060|Other|Primary care coordination|Referral to a local primary care provider, if none currently exists. Coordination of care with primary care provider.
16043868|NCT02569060|Other|Diabetes-appropriate food packages|Food (perishable and non-perishable) appropriate for diabetes self-management available for pick-up at the food pantry twice monthly.
16043869|NCT02569060|Behavioral|Diabetes self-management education|Education materials drawn from evidence-based practice and adapted from existing diabetes education curricula to be flexible to individual, community, and site variations. The Immediate Intervention Arm receives more robust diabetes self-management education (with group education visits) than the Waitlist Control Arm.
16043870|NCT02569047|Procedure|Atraumatic Restorative Treatment|No local anaesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with Glass Ionomer Cement (GIC).The cavity will be filled with GIC. After the press-finger technique, the excess of material will be removed.
16043945|NCT02568501|Behavioral|Financial incentive|Participant receive a $2 daily financial incentive framed as a loss with money allocated upfront and taken away each day of non-adherence to goal
16043946|NCT02568488|Drug|Metformin|850 mg orally twice daily for 6 months
16043994|NCT02568098|Drug|IVM, IVM and PQ, IVM and DHA-PQP, IVM and DHA-PQP and PQ|Regimen 1: IVM; Regimen 2: IVM and PQ; Regimen 3: IVM and DHA-PQP; Regimen 4: IVM and DHA-PQP and PQ;
16043871|NCT02569047|Procedure|Hall Technique|It employs the cementation of preformed metal crowns (PMC) without the need of any prior teeth preparation or caries removal. No local anesthesia is used neither tooth preparation.Different sizes of PMCs will be tested until the smallest size that perfectly fit the tooth is achieved. The PMC will be loaded with the dental material glass ionomer cement (GIC) and placed. Child will asked to bite firmly on it, until it is fitted. The excess of GIC will be removed with hand instruments and dental floss.
16043872|NCT02569034|Other|Functional Magnetic Resonance Imaging|"Both groups will have the fMRI performed once. The fMRI will be use to to dissociate activity associated with both reward wanting and reward liking using the EEfRT. Learning more about the brain basis of components of anhedonia in both young and older adults is important in the context of previous research showing that risk-taking behavior and reward sensitivity changes with age, enhancing the knowledge of anhedonia."
16043873|NCT02569034|Other|Effort-Expenditure for Rewards Task|"Both groups with have the EEfRT performed once. The EEfRT is an effort-based decision-making task that measures reward wanting, in contrast to commonly used anhedonia questionnaires, which focus on reward liking. This novel task may provide a useful measure of components of anhedonia in older adults and in different patient populations."
16043874|NCT02569021|Device|Biphasic DBS stimulation|"The following protocol will be followed for each subject. In between, baseline and novel stimulation settings there will be a 30-minute washout period with DBS in the off state.
~Current best/optimized DBS setting (considered baseline)
~DBS off for 30 minutes as a washout period
~Biphasic pulse stimulation mode (assessment at 0.5hr)
~Biphasic pulse stimulation mode (assessment at 1hr)
~Biphasic pulse stimulation mode (assessment at 2hr)
~Biphasic pulse stimulation mode (assessment at 3hr)"
16043875|NCT02569021|Other|Unified Parkinson's Disease Rating Scale|UPDRS is used by neurologists to rate the motor impairment of people with Parkinson's Disease.
16043876|NCT02569021|Other|Tremor Rating Scale|TRS is used by neurologists to rate the severity of a tremor.
16043877|NCT02569021|Device|Kinesia accelerometer|The kinesia accelerometer is used to analyze the tremor and slowness (bradykinesia) of the participants.
16043878|NCT02569021|Device|Trigno wireless system|The Trigno system measure muscle contractions.
16043879|NCT02569021|Other|GaitRite walking assessment.|GaitRite records a patients gait pattern.
16043880|NCT02569008|Drug|Fluid challenge with Compound Sodium Lactate|Infusion of the mentioned dose of Compound sodium Lactate over 5 minutes intravenously.
16043881|NCT02568995|Drug|ropivacaine + ketorolac + adrenaline|A combination of drugs injected locally for postoperative pain management
16043882|NCT02568982|Other|Exams and questionnaires|Blood sample 24hrs urinary cortisol and salivary cortisol, urinary labstick test, EKG, cardiac ultrasound, cardiac CT-scan, arterial and venous US ophthalmology examination spine X-Ray bone densitometry QoL questionnaires (SF-36, QoLCushing, Beck BDI-II)
16043883|NCT02568969|Device|Eirus continuous lactate monitor|a triple-lumen central venous catheter (Eirus TLC) functioning as a regular central venous catheter (CVC) with an integrated microdialysis function will be inserted via the left jugular vein for continuous monitoring of lactate and glucose using Eirus intravascular microdialysis system (Maquet Critical Care, Solna, Sweden) after calibration with arterial sample. Eirus TLC will be used for both drug administration and blood sampling and will be removed postoperatively when a central line will no longer be necessary.
16043884|NCT02568943|Drug|Panobinostat|Panobinostat (PAN [LBH589]) is an orally administered pan-deacetylase inhibitor (DACi) belonging to a structurally novel class of compounds deregulating cell proliferation and survival mechanisms of cancer cells.
16043885|NCT02568917|Procedure|Atraumatic Restorative Treatment - Ketac Molar Easy Mix|Occlusal and occlusal-proximal ART restorations in primary and permanent molars using the high viscosity GIC Ketac Molar Easy mix will be performed. No local anesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with GIC (Glass Ionomer Cement). The cavity will be filled with GIC. After the press-finger technique, the excess of material will be removed and occlusion will be checked.
16043886|NCT02568917|Procedure|Conventional Restoration - Composite Resin (Bulk Fill)|Occlusal and occlusal-proximal composite resin restorations in primary and permanent molars using the Scotchbond Multi-purpose adhesive system and the Filtek Bulk Fill composite resin wil be performed. Local anesthesia can be used if necessary. Access to caries lesion will be done using a round bur. Infected carious tissue will be removed with hand instruments. The cavity will be etched for 15 seconds followed by rising and drying for the same amount of time. The cavity will be restored with composite resin. Occlusion will be checked.
16043887|NCT02568904|Other|Alcohol|every participant will drink vodka at a dose of 2ml/kg bodyweight
16043888|NCT02568904|Other|Glucose|oral Glucose tolerance test
16043889|NCT02568904|Other|Fructose|oral fructose tolerance test
16043890|NCT02568904|Other|vehicle|control (water)
16043891|NCT02568891|Dietary Supplement|Probiotic|multispecies probiotic
16043892|NCT02568891|Dietary Supplement|Placebo|matrix
16043893|NCT02568878|Drug|Creatine monohydrate|
16043894|NCT02568865|Other|Physiological Sensors|Wearable biosensors can play an important role in depression diagnosis. For this study, we will use a cost-effective, unobtrusive, and non-stigmatizing sensor to monitor physiological signals (including heart rate (HR), heart rate variability (HRV), electrodermal activity (EDA), physical activity, and temperature).
16043895|NCT02568865|Other|Sleep Monitoring Device|The X4 Device is an internally battery powered FDA-classified Type BF device used for configurable acquisition of physiological signals via EEG.
16043896|NCT02568865|Other|Vocal Monitoring|The participants will be provided with a phone app to leave audio diary recordings.
16043897|NCT02568865|Other|Mobile Phone|A mobile phone and tablet will be used for various purposes, including, recording of socialization, location, and activity patterns of participants and to collect emotional information based on interactive surveys, as well as for forwarding sleep and physiological sensor measurements to a secure server.
16043898|NCT02568852|Procedure|Combined anaesthesia|Laparoscopic cholecystectomy under 10 mmHg pressure
16043899|NCT02568852|Procedure|General anaesthesia|Laparoscopic cholecystectomy under 10 mmHg pressure
16043900|NCT02568839|Drug|docetaxel + trastuzumab sc + pertuzumab|docetaxel 75-100 mg IV + trastuzumab sc 5 ml (600 mg) SC + pertuzumab 840 mg IV starting dose, subsequently 420 mg IV, repeated every 3 weeks, 6 courses
16043901|NCT02568839|Drug|trastuzumab emtansin|trastuzumab emtansine 3.6 mg/kg IV, repeated every 3 weeks, 6 courses
16043902|NCT02568826|Drug|3-glycosyl-3-Odemethylthiocolchicine derivative|IDN 5243 is a new muscle relaxant molecule. This molecule has showed significant anti-inflammatory activity by intraperitoneal route at 10 mg/kg in both carrageenan induced oedema and granuloma tests. IDN 5243 is a new 3-glycosyl-3-Odemethylthiocolchicine derivative endowed with muscle-relaxant, anti-inflammatory and analgesic activities. The primary packaging of test formulation will be a glass vial containing a solution of IDN 5243, 4 mg/ 1 mL. The secondary package will correspond to the patient's kit and will be a box containing ten (10) vials. The box label will be provided with a tear-off label.
16043903|NCT02568813|Behavioral|Multiscore Depression Inventory for Children scale|
16043904|NCT02568800|Drug|Prolonged Cefepime Infusion|Cefepime infusion should last at least 4 hours with the aide of an infusion bomb
16043905|NCT02568800|Drug|Usual Cefepime Infusion|Cefepime infusion occurs directly without the aide of an infusion bomb, lasting roughly thirty minutes
16043906|NCT02568787|Dietary Supplement|rice bran arabinoxylan compound (RBAC)|Take 2 tablets 1 time (1 gram) per day for the 3-month intervention period.
16043907|NCT02568787|Dietary Supplement|Placebo|Take 2 tablets 1 time (1 gram) per day for the 3-month intervention period.
16043908|NCT02568774|Other|Traditional Acupuncture|Treatment is based on the traditional Chinese medicine theory for treating overactive bladder. Qi-transforming function of bladder is regulated by experienced Chinese medicine practitioner.
16043909|NCT02568774|Other|Usual Care|Patients will receive conventional rehabilitation as usual, including standard physiotherapy, bladder training and general advise of fluid intake.
16043910|NCT02568761|Procedure|Injection Snoreplasty|Nonsurgical treatment involving the injection of 1.5 ml of 50% ethanol (1 ml of 99.5% ethanol diluted in 1ml of 2% xylocaine) into the upper palate.
16043911|NCT02568761|Other|Oropharyngeal Exercises|Myofunctional isometric and isotonic exercises of the soft palate, pharyngeal side walls, face and tongue.
16043912|NCT02568748|Biological|CIK|Cytokine -induced killer cells in Egyptian patients with advanced hepatocellular carcinoma as treatment or adjuvant treatment in comparison with traditional treatment.
16043913|NCT02568748|Procedure|TACE|Trans-arterial chemoembolization
16043914|NCT02568735|Drug|Dexketoprofen|After total hip replacement surgery patient were given either etoricoxib or dexketoprofen
16043915|NCT02568735|Drug|Etoricoxib|After total hip replacement surgery patient were given either etoricoxib or dexketoprofen
16043916|NCT02568722|Other|Standard RRT initiation|"In the absence of kidney function recovery, the initiation of RRT will be permitted if one of the following develops:
~serum potassium ≥ 6.0 mmol/L; pH ≤ 7.20 or serum bicarbonate ≤ 12 mmol/L; evidence of severe respiratory failure, based on a PaO2/FiO2 ≤ 200 and clinical perception of volume overload; and/or persistent AKI > 72 hours following the time of randomization."
16043917|NCT02568722|Other|Accelerated RRT initiation|A dialysis catheter will be placed and RRT initiated as soon as possible and within 12 hours of eligibility. This 12 hour window includes the time needed to obtain consent.
16043918|NCT02568709|Drug|Oxytocin|40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.
16043919|NCT02568709|Drug|Saline Nasal Spray|40 IU of the saline nasal spray will be administered once at the beginning of the visit.
16043920|NCT02568683|Drug|Entospletinib|ENTO spray dried dispersion tablets administered orally twice daily while in a fasted state
16043921|NCT02568683|Drug|Vincristine|VCR administered intravenously
16043922|NCT02568670|Other|clinical signs|to remove the peripheral venous catheter according clinical signs
16043923|NCT02568657|Device|Celox group|
16043924|NCT02568657|Device|Bakri Balloon|
16043925|NCT02568644|Dietary Supplement|Extract of ginger|People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two capsules of ginger extract (containing 5% of gingerols).
16043926|NCT02568644|Other|Cellulose|People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received two placebo capsules (cellulose).
16043927|NCT02568644|Drug|Intravenous ketoprofen|People (both genders) who went to the emergency room of the Hospital Vera Cruz (Belo Horizonte, MG, BR) with a migraine attack received intravenous ketoprofen (100mg).
16043928|NCT02568631|Other|serious game JeStiMulE|The objective of JeStiMulE players will be ending the game after a learning period and two playing periods (with emotional words and idioms, which include three modules each). The session ends when the module is completed, which is approximately one hour per module, or 6 sessions of play.
16043929|NCT02568631|Other|control video game|The patients will play 6 sessions of one hour with the control video game
16043930|NCT02568618|Genetic|Pain Medication DNA Insight (TM) test|The DNA insight test uses saliva to test the metabolism of certain pain and mental health medications to determine if the subject is a poor metabolizer, intermediate metabolizer or ultrarapid metabolizer.
16043931|NCT02568605|Dietary Supplement|Prebiotic fibre|Oligofructose-enriched inulin (Synergy1)
16043932|NCT02568605|Dietary Supplement|Placebo|Maltodextrin
16043933|NCT02568605|Behavioral|Weight Loss|All participants will receive 10 one-on-one sessions with a Registered Dietitian designed to achieve 10% weight loss over 6 months. The sessions will focus on nutrition education and behavior counseling to reduce food intake and improve dietary quality.
16043934|NCT02568592|Dietary Supplement|High Fat|High Fat - Carbohydrate (20%), Fat (65%), Protein (15%)
16043935|NCT02568592|Dietary Supplement|Normal|Normal - Carbohydrate (50%), Fat (35%) and Protein (15%)
16043936|NCT02568592|Dietary Supplement|Normal + Extra Fat|Normal + Extra Fat - Carbohydrate (50%), Fat (65%), Protein (15%). Carbohydrate and protein intake identical in absolute amounts to NORMAL, with an additional 30% extra energy coming from fat.
16043937|NCT02568579|Procedure|blood sample/ stool sample|blood sample to be done when possible with standard of care lab draw. Stool sample to be collected monthly at home.
16043938|NCT02568566|Other|Laboratory Biomarker Analysis|Correlative studies
16043939|NCT02568566|Biological|Recombinant Human Papillomavirus Nonavalent Vaccine|Given IM
16043942|NCT02568527|Device|PLGA scaffold|Poly-Lactic-co-Glycolic Acid (50:50) biodegradable, synthetic scaffold
16043995|NCT02568098|Drug|PQ and DHA-PQP and PQ|Regimen 5: PQ; Regimen 7: DHA-PQP and PQ
16043947|NCT02568475|Behavioral|"Provision of Go to the Hospital or Stay Here?"|Residents and families randomly assigned to the intervention group (one half of the residents and one half of the families enrolled) are given the new Decision Aid to review with an RA trained for this purpose by the investigators. The Decision Aid provides information on risks and benefits of acute care transfer and information on advance care planning, resident and families' right to be involved in the decision. Resident or family member is also asked to re-read it and think about it over the subsequent 14 days.
16043948|NCT02568462|Device|AmM APTITUDE Bioresorbable Drug-Eluting Coronary Scaffold|Placement of the investigational device into the diseased coronary artery to eliminate the vascular stenosis.
16043949|NCT02568449|Drug|Nintedanib|Given PO
16043950|NCT02568436|Radiation|low level laser therapy|low level laser therapy is intended to accelerate tooth movement
16043951|NCT02568423|Drug|Mirikizumab - IV|Administered IV
16043952|NCT02568423|Drug|Mirikizumab - SC|Administered SC
16043953|NCT02568423|Drug|Placebo - IV|Administered IV
16043954|NCT02568423|Drug|Placebo - SC|Administered SC
16043955|NCT02568410|Procedure|coronary artery bypass grafting using cardiopulmonary bypass|no study intervention. Study cohort will undergo coronary artery bypass grafting using cardiopulmonary bypass according to standard practices at DUMC
16043956|NCT02568397|Drug|Lanabecestat|Administered orally
16043957|NCT02568397|Drug|Dabigatran etexilate|Administered orally
16043958|NCT02568384|Device|Onyx BG Meter / App System|Subjects with diabetes used the Onyx BG Meter / App System at home and assessed software operations, ease of use of the system, and clarity and utility of user instructions.
16043959|NCT02568358|Other|Experimental Intervention: DNA-based testing of BAL fluid|DNA based testing needs 4.5 hours lab time in addition to standard testing
16043960|NCT02568345|Drug|sugammadex ED90|"The first patient received the dose of 2.4 mg/kg and if there was a negative response, the next patient would be allocated to receive the next higher dose of 2.6 mg/kg.
~In case that 2.4 mg/kg did produce a positive response, the next patient would be randomized with 10% of probability to receive the next dose of 2.2 mg/kg or 90% probability to receive the same dose of 2.4 mg/kg."
16043961|NCT02568332|Biological|AdCh3NSmut1|Genetic vaccine against Hepatitis C virus infection
16043962|NCT02568332|Biological|MVA-NSmut|Genetic vaccine against Hepatitis C virus infection
16043963|NCT02568319|Drug|LIPO-202|
16043964|NCT02568319|Drug|Placebo|
16043965|NCT02568306|Drug|NNC0165-1562|Administered subcutaneously (s.c., under the skin) single dose [SD] or multiple dose [MD] with daily dosing.
16043966|NCT02568306|Drug|placebo|Administered subcutaneously (s.c., under the skin) single dose [SD]) or multiple dose [MD] with daily dosing.
16043967|NCT02568293|Other|SBCV|SBCV is a single use, sterile product that acts as a localized physical barrier at the vascular wall.
16043968|NCT02568293|Other|Saline|Saline is used as a control.
16043969|NCT02568280|Drug|Faster-acting insulin aspart|Administered subcutaneously (S.C., under the skin).Subjects will be individually dosed.
16043970|NCT02568280|Drug|insulin aspart|Administered subcutaneously (S.C., under the skin).Subjects will be individually dosed.
16043972|NCT02568254|Device|Lens 1 (etafilcon A)|Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
16043973|NCT02568254|Device|Lens 2 (nelfilcon A)|Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
16043974|NCT02568254|Device|Lens 3 (nesofilcon A)|Each lens type will be worn for approximately 2 weeks (12 +/- 2 days).
16043975|NCT02568241|Other|Interferon Alfa-2b|High-risk acute leukemia patients receive prophylactic DLI at day 30-60 after hematopoietic stem cell transplantation,they received interferon α-2b (subcutaneously at dosages of 3 million units 2-3 times per week) . Interferon treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
16043976|NCT02568228|Dietary Supplement|Krill oil|The krill group and the control group will be double blinded. The krill oil and placebo capsules will be administered in equal amounts and are of equal size and have the same color.
16043977|NCT02568228|Other|Lean and fatty fish|The fish group will be open labeled.
16043978|NCT02568228|Dietary Supplement|Placebo capsules|The krill group and the control group will be double blinded. The krill oil and placebo capsules will be administered in equal amounts and are of equal size and have the same color.
16043979|NCT02568215|Biological|VRC01|Administered by IV infusion; total dose will vary based on participant's weight
16043980|NCT02568215|Biological|Placebo for VRC01|Sodium Chloride for Injection USP, 0.9%; administered by IV infusion
16043981|NCT02568202|Other|No treatment given|"This is an online web-based cross-sectional survey in which participants will complete one of two questionnaires.
~There will be no treatment."
16043982|NCT02568189|Device|SonoSite Maxx Series Ultrasound System|Ultrasound imaging is a non-radiating, non invasive modality to assess many areas of the body including vascular fluid status. By placing the probe on the abdomen and looking at the inferior vena cava the clinician can assess a patient's degree of dehydration. We are evaluating the utility of this diagnostic intervention within the clinical management of patients in the pediatric emergency department.
16043983|NCT02568176|Drug|Midazolam|Single oral dose of midazolam 6 mg Day 1 and Day 17.
16043984|NCT02568176|Drug|Esketamine|Intranasal esketamine will be self-administered 5 times during 15 days.
16043985|NCT02568176|Drug|Bupropion|Single oral dose of bupropion 150 mg on Day 1 and 19.
16043986|NCT02568163|Other|Non surgical periodontal treatment|
16043987|NCT02568150|Biological|Single group, open-label|
16043988|NCT02568137|Behavioral|Smart-phone based technology|
16043989|NCT02568124|Drug|Tranexamic Acid|
16043990|NCT02568124|Drug|Placebo|
16043991|NCT02568111|Drug|peginterferon beta-1a|SC administration as prescribed by the physician- initial dose of 63 μg followed by 94 μg dose on day 15 and 125 μg on day 29
16043992|NCT02568111|Drug|brimonidine tartrate|Applied to injection site as specified in the treatment arm. Commercially available Mirvaso (Brimonidine tartrate) gel will be provided by Galderma.
16043993|NCT02568111|Drug|Vehicle Gel|Matched placebo applied to injection site as specified in the treatment arm. Matching vehicle gel will be provided by Galderma.
16043996|NCT02568098|Drug|DHA-PQP|Regimen 6: DHA-PQP
16043997|NCT02568085|Device|Arista|Arista™ AH is a medical device intended for application to surgical wound sites as an absorbable hemostat. The device is a fine, dry, sterilized white powder that is biocompatible, non-pyrogenic, and is typically absorbed within 24 to 48 hours.
16043998|NCT02568059|Drug|Sahastara remedy alcoholic extract|comparison of different dose of drug
16043999|NCT02568046|Drug|Sym004|Sym004 is a 1:1 mixture of 2 monoclonal antibodies (mAbs), which bind specifically to 2 non-overlapping epitopes of the epidermal growth factor receptor (EGFR).
16044000|NCT02568046|Drug|FOLFIRI|The standard FOLFIRI regimen consists of Irinotecan (180 mg/m^2 IV, infused over 60-90 minutes) concurrently with Folinic Acid (400 mg/m^2 IV, infused over 120 minutes) followed by 5-FU (400 mg/m^2 IV bolus, then 2400 mg/m^2 infused over 46 hours).
16044001|NCT02568033|Drug|Pemetrexed|
16044002|NCT02568033|Drug|Carboplatin|
16044003|NCT02568033|Drug|Cisplatin|
16044004|NCT02568033|Drug|Docetaxel|
16044005|NCT02568033|Drug|Paclitaxel|
16044006|NCT02568033|Radiation|stereotactic radiosurgery|
16044007|NCT02568020|Drug|keto-amino acids|Ketosteril®( Fresenius Kabi) will be given at a dosage of one tablet/5kg ideal body weight/day, divided into three doses taken during meals.The patients will be followed-up for one year. The patients will come to the hospital every 4 weeks.
16044008|NCT02568007|Drug|Cyproheptadine|
16044009|NCT02567994|Drug|Teneligliptin|Subjects will visit the center on Week 4, 12 and 24 during the entire 24-week treatment period. Total study duration will be approximately 28weeks and the subjects will be to practice exercise/diet control together.
16044010|NCT02567981|Dietary Supplement|21 micronutrient-fortified supplement|21 micronutrient fortified supplement: Dose: 18.75g/day. Contains the following daily amounts per dose: Zinc 9 mg, Copper 300mcg, Iron 12mg, Vitamin D 5 mcg, Folic Acid 160mcg, Vitamin E 5mg, Iodine 90mcg, Calcium 200mg, Vitamin A 250mg, Phosphorus 150 mg, Vitamin C 40mg, Magnesium 40mg, Vitamin B12 0.9mcg, Selenium 17mcg, Thiamine 0.5mg, Manganese 0.17mg, Niacin 6mg, Biotin 8mg, Riboflavin 0.5mg, Vitamin B5 1.8mg, Vitamin B6 0.5 mg. Formula (percentage by weight): Maize 64.08%, Soy Beans 30%, Vitamins and Minerals 5.92%, BHA 0.006%. Energy: 73kcal, Protein 4g, Fat 1g, Dietary Fiber 2g, Carbohydrates 12g.
16044011|NCT02567981|Dietary Supplement|Cereal Fortificado (Fortified Cereal)|"Cereal Fortificado Dose: 45g/day. Contains the following daily amounts per dose: Vitamin A 226.6mcg, Thiamine 0.058mg, Riboflavin 0.202mg, Niacin 2.16mg, Panthotenic acid 3.015mg, Vitamin B6 0.765mg, Folate 27mcg, Vitamin B12 0.9mg, Vitamin C 45mg, Vitamin D 1.8mcg, Vitamin E 3.735mg, Vitamin K 45mcg, iron 3.6mg, Zinc 1.8mg, Iodine 18mcg, potassium 180mg, phosphorus 90 mg, calcium 58.50mg. Percentage weight: 58% corn, 20% soy, Skim dry milk 8%, Sugar 9%, Soy Oil 3%, Vitamins and Minerals 0.2%, calcium phosphate 1.23%, Potassium chloride 0.27%. Energy 184.5 kcal, protein 7.2%, Fat 4.1%, Fiber 1.4%, Ash 4.6%."
16044012|NCT02567981|Dietary Supplement|Ferrous sulphate|"Ferrous sulfate drops children <12 months: 12,5mg elemental iron/day (continuous). Children from 12-23.9months: elemental iron 25mg/day (continuous).
~Chidlren from 24 to 59 months: 1ml/day for two months, every 6 months."
16044013|NCT02567981|Dietary Supplement|Vitamin A|Vitamin A Capsules: children <12 months: 100.000 IU/6 months. Children 12-59 months: 200.000 IU/6 months.
16044014|NCT02567968|Drug|Caffeine|Anesthetized volunteers will be allowed to wake after injection of caffeine (15 mg/ kg). The time to wake will be measured.
16044015|NCT02567968|Drug|Placebo Control|Anesthetized volunteers will be allowed to wake after injection of saline (placebo control). The time to wake will be measured.
16044016|NCT02567955|Biological|Immunogenicity two doses of Gardasil-9|Subjects will receive two standard doses of Gardasil-9 (0.5 ml)
16044017|NCT02567955|Biological|Immunogenicity Cervarix and Gardasil-9|Subjects will receive a standard dose of Cervarix (0.5 ml) and a standard dose of Gardasil-9 (0.5 ml)
16044018|NCT02567942|Drug|propofol group|Patient will be anesthetized by using propofol infusion during operation
16044019|NCT02567942|Drug|sevoflurane group|Patient will be anesthetized by using sevoflurane inhalation during operation
16044020|NCT02567929|Drug|propofol group|Patient will be anesthetized by using propofol infusion during operation.
16044021|NCT02567929|Drug|sevoflurane group|Patient will be anesthetized by using sevoflurane inhalation during operation.
16044022|NCT02567916|Drug|Fresofol|
16044023|NCT02567916|Drug|Propofol|
16044024|NCT02567903|Device|Thigh Tourniquet|Knee arthroscopy with the use of a thigh tourniquet that is inflated to 100-150 mmHg above systolic blood pressure.
16044025|NCT02567903|Procedure|Knee arthroscopy|Knee arthroscopy
16044026|NCT02567890|Behavioral|Internet-based DBI|Participants will go through a four week interactive program that will improve body acceptance. Includes some homework assignments and monitoring.
16044027|NCT02567890|Behavioral|Expressive writing|Participants will be asked to reflect upon issues related to body image.
16044028|NCT02567877|Procedure|thyroidectomy|Patients enrolled in the study will undergo a clinically-indicated thyroidectomy performed as standard of care.
16044029|NCT02567877|Drug|levothyroxine in thyroidectomy patients|Patients will initiate levothyroxine treatment after surgery consistent with standard of care. The drug dosage will be titrated to TSH goal that matches the pre-surgery TSH (+/- 1 mIU/L)
16044030|NCT02567864|Other|Healthy Beat Accupunch exercise program|HBA has three phases and takes 40 minutes to complete.
16044031|NCT02567864|Other|control|participants maintain their daily activities.
16044032|NCT02567851|Drug|Brentuximab Vedotin|Monoclonal antibody drug conjugate
16044033|NCT02567838|Drug|Lidocaine gel|Instillagel (2% lidocaine) was administered rectally prior to probe insertion.
16044034|NCT02567838|Drug|Placebo|Placebo (Aquagel) was administered rectally prior to probe insertion.
16044035|NCT02567825|Device|Tympanostomy tube placement|As per routine care, tympanostomy tubes will be inserted under general anesthesia, using a small radial incision in the anteroinferior portion of the tympanic membrane; a Teflon® Armstrong-type tympanostomy tube will be used.
16044036|NCT02567825|Drug|Amoxicillin-Clavulanate and/or Ceftriaxone|Children randomized to nonsurgical management will receive stepwise therapy with amoxicillin-clavulanate (90/6.4 mg/kg in two divided doses for 10 days), and in the event of inadequate response, ceftriaxone (75 mg/kg intramuscularly, repeated in 48 hours), as recommended in the American Academy of Pediatrics guidelines.
16044151|NCT02567006|Behavioral|SMS message|SMS messages will be delivered at 6, 4, and 2 days before the next scheduled date of the primary vaccines for the intervention group
16044037|NCT02567825|Drug|Ofloxacin Otic|Participants randomized to receive tympanovstomy tubes will also be followed overtime for recurrences of AOM and treated with topical ofloxacin (Floxin® 0.3%, 5 mL) 5 drops into the affected ear twice daily for 10 days. Persistence of otorrhea after 7 days of treatment will be considered inadequate response, and children so affected will be prescribed empiric amoxicillin-clavulanate (90/6.4 mg/kg/day in two divided doses) followed by culture-directed therapy 48 hours later.
16044038|NCT02567799|Drug|BIO 300 Oral Suspension|Cohort 1: BIO 300 500 mg Cohort 2: BIO 300 1,000 mg Cohort 3: BIO 300 1,500 mg Cohort 4: BIO 300 Optimal dose (TBD) BIO 300 dose will be given daily, 7 days/week (Week 1, day 1 through week 6) The 2nd and 3rd dosing cohort (1,000 and 1,500 mg/day) will begin following the accrual of a minimum of 6 subjects at the previous dose level, dose escalation to the next BIO 300 dose level will be allowed to occur when a cohort has completed concurrent chemoradiotherapy with fewer than 33% Dose Limiting Toxicities (DLTs) attributed to BIO 300 Oral Suspension.
16044039|NCT02567799|Drug|Paclitaxel|"During the Concurrent Therapy period, paclitaxel 45 mg/m2 will be administered by intravenous drip weekly during weeks 1-6.
~During the Consolidation Therapy period, paclitaxel 200 mg/m2 will be administered by intravenous drip two times, 21 days apart."
16044040|NCT02567799|Drug|Carboplatin|"During the Concurrent Therapy period, area under the curve (AUC) = 2mg* min/mL will be administered by intravenous drip weekly during weeks 1-6.
~During the Consolidation Therapy period, carboplatin AUC = 6mg*min/mL will be administered by intravenous drip two times, 21 days apart."
16044041|NCT02567799|Radiation|Radiotherapy|Radiation treatment will be scheduled at the discretion of the investigator provided the subject has completed a minimum of 2 days of BIO 300 dosing. Subjects will receive radiation therapy 5 days per week, once daily fractions, 1.8-2.0 Gy per fraction, for 6-7 weeks.
16044042|NCT02567786|Procedure|Surgery with CPB|
16044043|NCT02567786|Other|Fresh Frozen Plasma|
16044044|NCT02567786|Other|Plasmalyte|
16044045|NCT02567773|Drug|GSK2881078|GSK2881078 hot melt solutions, ranging in concentration from 0.05 mg/g to 50 mg/g, will be prepared by weighing drug substance directly into specific quantities of the hot melt vehicle solution. Subjects will be administered GSK2881078 (dose for Cohort 1: 0.75 mg for females and 1.5 mg for males) hot melt solution within capsule orally with water.
16044046|NCT02567773|Drug|Placebo|Subjects will be administered as hot melt vehicle placebo within capsule orally with water.
16044047|NCT02567773|Drug|Itraconazole|Subjects will be administered as two capsules of itraconazole 100 mg (200 mg) orally with water.
16044048|NCT02567760|Dietary Supplement|MP1|Subjects receive MP1 drink at the dose of 400 mg/day after meal for 8 weeks.
16044049|NCT02567760|Other|Placebo|Subjects receive Placebo drink after meal for 8 weeks.
16044050|NCT02567747|Other|Data collection|Data will be collected retrospectively for cases identified through RIPS*/ DANE** from 2008 until 2014 and through PAI*** from 2009 until 2014. *Registro Individual de Prestación de Servicios de Salud (RIPS) database (Health Service Provider Individual Registration Database), Columbia. **Departamento Administrativo Nacional de Estadística (DANE) database (The National Administrative Department of Statistics database), Columbia. ***Programa Ampliado de Immunizaciones (PAI) database (National Immunization Program database), Columbia.
16044051|NCT02567734|Procedure|CT-guided percutaneous irreversible electroporation|Patients undergo the irreversible electroporation ablation that induce protracted cell death by apoptosis through cell membrane perforation.All these procedures will be performed under the guide of Big bore multislice spiral CT scanning system.
16044052|NCT02567721|Other|Vaccine safety surveillance|Extraction of routinely collected primary care data from nine GP practices and an active surveillance approach in 3 of the 9 GP practices, by using an existing card-based ADR reporting system (MHRA Yellow Card), to estimate proportions of AEIs among seasonal influenza-vaccinated individuals.
16044053|NCT02567708|Drug|GSK2269557 DPI|GSK2269557 will be supplied as a lactose blend in a DISKUS DPI with a unit dose strength of 500 mcg. 2 inhalations will be taken every morning before breakfast.
16044054|NCT02567708|Drug|Placebo DPI|Placebo will be lactose in a DISKUS DPI. 2 inhalations will be taken every morning before breakfast.
16044055|NCT02567695|Drug|GBT440|Test: GBT440 300 mg capsule (high-strength) Reference: GBT440 100 mg capsule (low-strength)
16044056|NCT02567682|Drug|GBT440|GBT440 capsules followed by Caffeine, S-warfarin+vitamin K, Omeprazole, and Midazolam
16044057|NCT02567669|Radiation|standard postoperative radiotherapy for breast cancer|subjects will undergo ct scans to assess muscle mass and questionnaires to assess fatigue at 4 defined time points during and after radiotherapy
16044058|NCT02567656|Drug|RP6530|Tablet starting at 200 mg
16044059|NCT02567643|Radiation|Stereotactic Radiosurgery|
16044060|NCT02567630|Behavioral|Soft Mitt Constraint Therapy for Sensory/Motor Impairment in Cerebral Palsy|The CIMT intervention includes 3 components: (1) placement of a removable soft constraint for ½ each day, with a non-invasive wear monitor (2) demonstration and prescribed home-use of a sensory kit (3) and a reach/grasp tool. The intervention lasts 4 weeks as has been published in older children as well as used in infant trial descriptions.
16044061|NCT02567617|Dietary Supplement|Polyphenols|Capsules with five substances (polyphenols) at a concentration of 3000mg per day
16044062|NCT02567617|Dietary Supplement|Placebo controlled|Starch capsules
16044063|NCT02567604|Behavioral|Focus Groups|at least three focus groups lasting approximately one hour
16044064|NCT02567591|Other|Physical activity|walk (three times per week) and muscle building twice per week with the use of elastic bands. They will include 5 strengthening exercises mobilizing large muscle groups of the lower limbs (abs (if possible for the patient), hamstrings, quadriceps, triceps sural and gluteus maximus).
16044065|NCT02567578|Drug|YH12852 0.1 mg|
16044066|NCT02567578|Drug|YH12852 0.25 mg|
16044067|NCT02567578|Drug|YH12852 0.5 mg|
16044068|NCT02567578|Drug|Placebo|
16044069|NCT02567565|Other|LipiView|tear film lipid layer thickness measured by LipiView interferometer (TearScience Inc, Morrisville, NC)
16044070|NCT02567552|Drug|Subcutaneous progesterone|subcutaneous progesterone 25 mg/day
16044071|NCT02567552|Drug|Intramuscular progesterone|intramuscular progesterone 50 mg/day
16044072|NCT02567539|Radiation|IMRT with or without radiosensitive therapy|Re-irradiation with hypofractionated intensity modulated radiation therapy (IMRT), using VMAT RapidArc
16044073|NCT02567539|Drug|Radiosensitive therapy|Radiosensitive therapy with Temozolomide
16044074|NCT02567526|Behavioral|Between-Meal Intervention Group|Non-nursing staff trained as Feeding Assistants were responsible for supplement and snack delivery in the mornings and afternoons between meals supervised by research staff
16044075|NCT02567513|Behavioral|Supplement Intervention|Supplements given twice/day, 5 days/week, for 24 weeks by research staff.
16044076|NCT02567513|Behavioral|Snack Intervention|Snacks given twice/day, 5 days/week for 24 weeks by research staff.
16044077|NCT02567500|Behavioral|Patients with auditory hallucination|"Patients with auditory hallucination (20 for each arm):
~Evaluation at time 0 and 6 month after of:
~The social cognitive marker (NEPSY II) : theory of mind and affect recognition
~The emotional marker:
~Differential emotion scale IV (DES IV): emotional individual stability
~Revised Beliefs About Voices Questionnaire (BAVQ-R): a self report measure of patients' beliefs, emotional and behavior about auditory hallucination.
~Evaluation of auditory hallucinations persistence with a self report scale using in recruiting criteria.
~Evaluation of diagnosis with DSM-IV criteria:
~MINI-Kids
~Psychosis section of Kiddie-SADS"
16044078|NCT02567500|Behavioral|Patients without auditory hallucination|"Patients without auditory hallucination (20 for each arm):
~Evaluation at time 0 and 6 month after of:
~The social cognitive marker (NEPSY II) : theory of mind and affect recognition
~The emotional marker:
~Differential emotion scale IV (DES IV): emotional individual stability
~Revised Beliefs About Voices Questionnaire (BAVQ-R): a self report measure of patients' beliefs, emotional and behavior about auditory hallucination.
~Evaluation of auditory hallucinations persistence with a self report scale using in recruiting criteria.
~Evaluation of diagnosis with DSM-IV criteria:
~MINI-Kids
~Psychosis section of Kiddie-SADS"
16044079|NCT02567487|Drug|Levobupivacaine|Transversus abdominis plane block with levobupivacaine
16044080|NCT02567474|Behavioral|5 A model|self management program based on 5A model
16044081|NCT02567461|Drug|Edoxaban 60 mg|Patients will receive randomized treatment for 10±2 days, in order to achieve steady-state anticoagulant effects. Afterwards, patients randomized to any of the edoxaban groups (arms 1 and 2) will stop aspirin therapy. Study treatment will be administered for other 10±2 days.
16044082|NCT02567461|Drug|Edoxaban 30 mg|Patients will receive randomized treatment for 10±2 days, in order to achieve steady-state anticoagulant effects. Afterwards, patients randomized to any of the edoxaban groups (arms 1 and 2) will stop aspirin therapy. Study treatment will be administered for other 10±2 days.
16044083|NCT02567461|Drug|Clopidogrel 75 mg|Patients will receive randomized treatment for 10±2 days, in order to achieve steady-state anticoagulant effects. Afterwards, patients randomized to any of the edoxaban groups (arms 1 and 2) will stop aspirin therapy. Study treatment will be administered for other 10±2 days.
16044084|NCT02567461|Drug|Aspirin 81 mg|Patients will receive randomized treatment for 10±2 days, in order to achieve steady-state anticoagulant effects. Afterwards, patients randomized to any of the edoxaban groups (arms 1 and 2) will stop aspirin therapy. Study treatment will be administered for other 10±2 days.
16044085|NCT02567448|Other|Sleep and pulmonary physiologic measurements|Two overnight sleep studies, CT scan of upper airway and chest, pulmonary function test and pharyngeal lavage
16044086|NCT02567435|Drug|Cyclophosphamide|Given IV and PO
16044087|NCT02567435|Biological|Dactinomycin|Given IV
16044088|NCT02567435|Drug|Irinotecan Hydrochloride|Given IV
16044089|NCT02567435|Other|Laboratory Biomarker Analysis|Correlative studies
16044090|NCT02567435|Other|Questionnaire Administration|Ancillary studies
16044091|NCT02567435|Radiation|Radiation Therapy|Undergo RT
16044092|NCT02567435|Drug|Temsirolimus|Given IV
16044093|NCT02567435|Drug|Vincristine Sulfate|Given IV
16044094|NCT02567435|Drug|Vinorelbine|Given IV
16044099|NCT02567409|Drug|Berzosertib|Given IV
16044100|NCT02567409|Drug|Cisplatin|Given IV
16044101|NCT02567409|Drug|Gemcitabine Hydrochloride|Given IV
16044102|NCT02567396|Other|Laboratory Biomarker Analysis|Correlative studies
16044103|NCT02567396|Other|Pharmacological Study|Correlative studies
16044104|NCT02567396|Drug|Talazoparib|Given PO
16044105|NCT02567383|Radiation|Radiation|5-Gy once a week for a subtotal of 10Gy/2fx a week to gross tumors, followed by 40Gy/20fx/4 weeks, total 50Gy/22fx/5weeks
16044106|NCT02567383|Device|Hyperthermia; Thermotron RF-8|40 minutes within 2hr after irradiation
16044107|NCT02567383|Drug|Cisplatin|20mg/m2 per week for 6 weekly cycles before radiotherapy
16044108|NCT02567383|Drug|Taxotere|10-12mg/m2 per week for 6 weekly cycles before radiotherapy
16044109|NCT02567370|Drug|AMG 581|Active drug
16044110|NCT02567370|Drug|Placebo|Placebo
16044111|NCT02567357|Behavioral|Visual Scheduling|Caregivers will present a visual schedule with pictorial representations of activities/events expected to occur each day will be presented to children at set times of day (tailored for individual's schedules). Ultimately caregivers will aim to ensure that activities occur as per the schedule as far as possible - thus decreasing the child's level of exposure to unexpected changes in routines or plans.
16044112|NCT02567357|Behavioral|signalling change|Caregivers will present a distinct visual-verbal cue card whenever they become aware that a change to the child's routine or plan is about to occur. Thus, the intervention uses a stimulus control approach so that the child learns that presentation of the cue reliably predicts the subsequent occurrence of a change to routine/plan, and the change is therefore more predictable and easier for the child to deal with.
16044113|NCT02567344|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|rTMS will be delivered at 110% rMT to the Left DLPFC with 5 seconds on, 10 seconds off for 4000 pulses.
16044114|NCT02567344|Device|Sham Repetitive Transcranial Magnetic Stimulation|rTMS will be delivered via an electronic sham coil that mimics real rTMS in appearance, sound, and feeling. Pulses will be delivered to the Left DLPFC with 5 seconds on, 10 seconds off for 4000 pulses.
16044115|NCT02567331|Drug|Capecitabine|Participants will receive 1250 mg/m^2 capecitabine administered twice daily as oral tablets for 14 days followed by a 7 day rest period for up to 6 treatment cycles.
16044116|NCT02567318|Device|MRI-scan|Magnetic resonance imaging scan of the brain
16044117|NCT02567305|Other|Markers of NET formation|i.e. Plasma DNA, Histone, MPO, DNase
16044118|NCT02567292|Other|Human Milk|Participants will receive an exclusive human milk diet comprised of mother's own milk (MOM, pasteurized donor human milk (DM) fortified with a donor-milk based fortifier (DMBF): Prolact+ for infants <37 weeks PMA and/or or weight <2,200g or PBCLN-002 for infants >37 weeks PMA and/or weight >2,200g)
16044119|NCT02567279|Drug|Denosumab subcutaneous injections|Subcutaneous injection of Denosumab 60 mg, one injection at baseline and another injection at 6 months
16044120|NCT02567279|Drug|Placebo subcutaneous injections|Subcutaneous injection of Placebo, one injection at baseline and another injection at 6 months
16044121|NCT02567266|Behavioral|Unified Protocol for Adolescents (UP-A)|The UP-A is an emotion-focused, transdiagnostic approach for adolescents (ages 12-18) with a primary emotional disorder. It is a developmental adaptation of the Unified Protocol, a transdiagnostic treatment for adults with emotional disorders. Clinicians present all skills in the context of the emotions most salient to presenting concerns and adolescent/caregiver conceptualizations of treatment needs, thereby personalizing treatment. The UP-A is delivered in 8-21 weekly sessions, with clinician flexibility regarding the sequencing and depth with which various sections are presented to clients and caregivers, as well as the emotions targeted during the course of the intervention.
16044122|NCT02567266|Behavioral|Youth Outcomes Questionnaire|"The YOQ consists of parent- and youth-report measures of symptoms and alliance administered weekly on a tablet computer. The YOQ online system then generates reports to provide clinicians with systematic feedback about client progress, flagging critical items that have been endorsed (e.g., suicidality, hallucinations), presenting graphs of ratings over time, and providing empirically-derived alerts when clients are failing to progress or showing deterioration. Clinicians will be trained to use this feedback to modify treatment as needed, share it with families as appropriate, and use it to enhance use of supervision."
16044123|NCT02567266|Behavioral|Treatment as Usual|Clinicians assigned to the TAU condition will be instructed to use whatever treatment methods and outcome monitoring strategies they typically use with adolescents with internalizing disorders.
16044124|NCT02567253|Procedure|Cytoreductive surgery|Complete or nearly complete (CC-0 or CC-1) macroscopic cytoreduction at the time of surgery of peritoneal carcinomatosis from ovarian cancer
16044125|NCT02567253|Drug|IPEC with Cisplatin (75mg/m²)|Intraperitoneal normotherm (37°C) administration of Cisplatin (75mg/m²) , during 90min
16044126|NCT02567253|Drug|IPEC with Cisplatin (100mg/m²)|Intraperitoneal normotherm (37°C) administration of Cisplatin (100mg/m²), during 90min
16044127|NCT02567253|Drug|Hypertherm IntraPEritoneal Chemotherapy with Cisplatin (75mg/m²)|Intraperitoneal hypertherm (41°C) administration of Cisplatin (75mg/m²), during 90min
16044128|NCT02567253|Drug|HIPEC with Cisplatin (100mg/m²)|Intraperitoneal hypertherm (41°C) administration of Cisplatin (100mg/m²), during 90min
16044129|NCT02567240|Other|Carbon monoxide-bubbled mediums|Islets will be harvested with carbon monoxide bubbled mediums
16044130|NCT02567227|Other|Cognitive Remediation|This computerized program has successfully been used by seniors in different settings. It trains a number of cognitive processes including attention and Executive Function.The Cognitive Remediation (CREM) training is constructed based on the program's built in baseline cognitive evaluation.
16044131|NCT02567227|Other|Active Control|Computer, multimedia and group based health education programs.
16044132|NCT02567214|Drug|Ultibro®|The intervention in this arm is the Ultibro®. To keep the patients blinded on which treatement they are taking they will use the two devices but in this arm the Ultibro will be delivered and the Spiriva will be a placebo. We will measure the exertional dyspnea after 21 days of treatment.
16044133|NCT02567214|Drug|Spiriva®|The intervention in this arm is the Spiriva®. To keep the patients blinded on which treatement they are taking they will use the two devices but in this arm the Ultibro will be a placebo and the Spiriva will be delivered. We will measure the exertional dyspnea after 21 days of treatment.
16044134|NCT02567201|Other|electrophysiological evaluation|electrophysiological assessment (experience 1 : passive ; experience 2 : active versus passive ; experience 3 : active, with feedback) Experience 1, 2, 3 : one session maximum by experience
16044135|NCT02567201|Other|electrophysiological evaluation of patients|electrophysiological assessment (experience 1 : passive ; experience 2 : active versus passive ; experience 3 : active, with feedback) Experience 1 : maximum one session by sensory modality of stimulation (auditory, tactile, or visual) Experience 2 : maximum one session by sensory modality of stimulation (auditory, tactile, or visual) Experience 3 : Stimulation = auditory or visual ; possibility of several sessions if the patient is tired.
16044136|NCT02567188|Other|MIRCERA|
16044137|NCT02567175|Drug|Domperidone|
16044138|NCT02567149|Drug|Cidofovir|Cidofovir
16044139|NCT02567123|Behavioral|Experimental|
16044140|NCT02567097|Behavioral|Self-Incentive|Participants are asked to form plans to quit smoking using various descriptions specified dependent on the arm in which they are randomised.
16044141|NCT02567084|Device|"CERAMENT™ |BONE VOID FILLER"|Implantation of bi-phasic ceramic bone substitute to provide bone generation and bone remodeling in patients with benign bone tumors.
16044142|NCT02567071|Other|perineal impregnated swab|After planned C-section birth, newborns will suck on previously impregnated swab by perineal and vaginal mother secretions.
16044143|NCT02567071|Other|clean swab|After planned C-section birth, newborns will suck on clean swab.
16044144|NCT02567058|Device|Ultrasound exam|"Ultrasound exam with :
~2 successions of 3 measures repeated for 2 visits (day 0 and day 21) for group I
~1 succession of 3 measures repeated for 4 visits (day 0, day 14, day 45, day 90)for group II
~1 succession of 3 measures for group III"
16044145|NCT02567058|Behavioral|IPAQ questionnaire|IPAQ questionnaire
16044146|NCT02567045|Procedure|annual FIT and colonoscopy in case of a positive test|FIT and colonoscopy in case of a positive test. Annual interval (2 rounds), without diet restriction, 1 stool sample. Positive cut-off 10 mcg Hemoglobin/g feces.
16044147|NCT02567045|Procedure|colonoscopy with sedation|One-time Colonoscopy with sedation.
16044148|NCT02567032|Drug|Oxytocin|40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.
16044149|NCT02567032|Drug|Saline Nasal Spray|40 IU of the saline nasal spray will be administered once at the beginning of the visit.
16044150|NCT02567019|Other|blood samples|blood samples will be done for patients patients suffering of periodontal diseases and healthy volunteers
16044159|NCT02566954|Other|3D measurement of the lower limb by EOS|"The intervention is to performed an additional radiologic exam by the EOS® system of imaging. This imaging is not usually realized for the patient.
~3 dimensional study of lower limbs and feet of children in standing position will be performed using the EOS® system (EOS® Imaging, France)"
16044160|NCT02566941|Device|Gymna Belgium, DUO 400 (Neuromuscular electrical stimulation)|
16044161|NCT02566928|Drug|2% mupirocin ointment|Index patients and consenting household members will complete a decolonization regimen consisting of twice-daily application of mupirocin ointment to the anterior nares with a sterile cotton applicator for five days.
16044162|NCT02566928|Other|Chlorhexidine wash|Index patients and consenting household members will daily daily for five days with chlorhexidine wash.
16044163|NCT02566928|Behavioral|Hygiene protocol|Index patients and consenting household members will be given educational materials and instructed to in the use of hand-washing, surface disinfection, and laundering.
16044164|NCT02566915|Device|CPET submaximal with EPAP|The expiratory positive pressure is applied through silicone mask (RHDSON Vital Signs®, New Jersey, USA) containing one-way valve and a resistance mechanism expiratory positive expiratory pressure generator adjustable 5-20 cm H2O (Spring Loaded) (Vital Signs® , New Jersey, USA). The mask one headgear will be comfortably adjusted to face being used to prevent air leakage, and the pressure level gradually adjusted to the level of 10 cm H2O.
16044165|NCT02566902|Device|T-Piece Nebulizer|Albuterol treatment administered with Hudson RCI® Micro Mist® nebulizer (Teleflex Medical®, Research Triangle Park, NJ)
16044166|NCT02566902|Device|Breath-Enhanced Nebulizer|Albuterol treatment administered with NebuTech® HDN®, Breath-Enhanced High Density Jet Nebulizer (Salter Labs®, Arvin, CA)
16044167|NCT02566902|Drug|Albuterol|One time 5mg nebulized albuterol treatment given with one of two devices over 10 minutes.
16044168|NCT02566902|Procedure|Pre-Treatment Spirometry Measurement|Bedside spirometry measurements taken prior to albuterol therapy using ndd® EasyOne Plus® spirometer.
16044169|NCT02566902|Procedure|Post-Treatment Spirometry Measurement|Bedside spirometry measurements taken after albuterol therapy using ndd® EasyOne Plus® spirometer.
16044170|NCT02566889|Drug|Infliximab|Participants in the dose escalation group will escalate dose from infliximab 5 mg/kg q8w to 10 mg/kg q8w at the time of loss response. Participants in the reference group will be maintained on infliximab 5 mg/kg q8w.
16044171|NCT02566876|Drug|Mixture of three Bifidobacteria|This investigation will be a randomized, double-blind, placebo-controlled, cross-over trial. The study will include 70 children with FD or IBS and will be articulated in 16 weeks as follows. Fifty-nine children (median age 11.2 years, range 5.2-17.9) with IBS and FD were randomized to receive either a mixture of three Bifidobacteria or a placebo for 6 weeks. At the end, after a 2-week-''washout'' period, each patient was switched to the other group and followed for 6 further weeks. At baseline and at follow-up, patients and/or their parents completed a dairy for bowel habit and gastrointestinal symptoms, and a quality of life (QoL) questionnaire.
16044173|NCT02566850|Device|Ekso|powered lower extremity exoskeleton
16044174|NCT02566837|Procedure|Ultrasound|ultrasound imaging to guide the intramuscular injections of botulinum toxin : Ultrasound is used to identify the target muscle, and for guiding the insertion of the needle in the muscle. Once the needle is positioned, the botulinum toxin is injected
16044175|NCT02566837|Procedure|electrical stimulation|electrical stimulation (reference technique currently recommended over muscle palpation and anatomical landmarks) to guide intramuscular injections of botulinum toxin. Intramuscular injection is carried out in register with the zone where is located the theoretically target muscle. Electrical stimulation (mediated by the tip of the needle) used to verify the correct position of the needle, and reposition it if necessary. Once the needle is correctly positioned, the botulinum toxin is injected.
16044176|NCT02566824|Behavioral|Cognitive Behavioural & Skills Training|This will be administered in groups of 10 participants in 12 sessions each lasting 1.5 hours. Each session will focus on a new topic- Modules will be introduced via role play illustrating the topic, followed by Q&A. Strategies will be introduced to address the problems illustrated. Adolescents will practice using these strategies via planned activities or games. Obstacles to applying the skills in everyday life will be discussed and a physical reminder will be provided for each skill. A homework activity will be assigned to help participants practice the skill during the week. Each session will begin with homework review. Adolescents will also receive individual telephone coaching twice a week during the 12 weeks, which will taper off during the follow-up phase. Parents will also attend their own support group.
16044177|NCT02566824|Behavioral|Supportive Group Therapy|This will be administered in groups of 10 participants in 12 sessions each session lasting 1.5 hours. During the initial session group members will be asked to identify a specific goal to address during the program. Each session will review the previous week's events (challenges and positive accomplishments) and psychoeducation on a topic relating to ADHD (topics will be elicited from group members at the outset of each session). Adolescents will also receive a telephone coaching at the same frequency as the CBT+S group participants. These phone calls will deal with issues a given participant had raised in the preceding session, and the approach will emphasize support and unconditional positive regard. Parents will also attend their own support group.
16044178|NCT02566824|Other|Treatment as Usual - community resources|The treatment as usual group reflects what patients currently receive in the community (mainly medication). Participants will be stabilized on optimal medication (if they choose to be on medication) and referred back to the community for follow-up. Participants are free to seek out any additional interventions that they feel are required. These participants will be evaluated at the same intervals as the two therapy groups. They will receive a follow-up phone call from the study coordinator at two-month intervals in-between evaluation points. If participants indicate during the phone call that they require services, they will be referred to services in the community.
16044210|NCT02566590|Device|NMES|device is used to stimulate muscle contraction in the legs of the patient. The intervention will be used 3 times a day during bed rest.
16044211|NCT02566590|Dietary Supplement|Protein|supplement will used to enhance muscle anabolism. The intervention will be provided 3 times a day during bed rest.
16044496|NCT02564471|Drug|Atovaquone and Proguanil|FDA approve dosing schedule
16044179|NCT02566824|Drug|Methylphenidate or amphetamine product|Medication is titrated over a 4-week period with stepwise increments each week. Participants, parents and teachers complete ADHD symptom scales at baseline and before each medication visit. They will also complete side effects scales at baseline and before each medication visit. The gradual increase will continue until there is no further improvement in symptoms and in the Clinical Global Improvement Scale or side effects are such that further increases are not indicated. Once the optimal dose is reached, the participants remain on this dose for the remainder of the study.
16044180|NCT02566811|Procedure|Abdominal surgery|Hysterectomy defined as an extrafascial hysterectomy whereby the cervix is removed completely but no radical dissection of the parametria is required
16044181|NCT02566811|Procedure|Lymphadenectomy|Bilateral pelvic and para-aortic lymph node dissection
16044182|NCT02566798|Drug|Extract of grape and olive|"Patients are taking capsules of OleograpeSEED 3 times a day (1mg/day) in the morning, at noon and in the evening during 7 days.
~Blood samples and synovial fluid are performed on D0 and D7"
16044183|NCT02566798|Drug|Lactose|"Patients are taking capsules of placebo 3 times a day in the morning, at noon and in the evening during 7 days.
~Blood samples and synovial fluid are performed on D0 and D7"
16044184|NCT02566785|Other|Balance Intervention|The multi-component balance intervention will be 1x per week in supervised group sessions and 2x a week sessions at home. Sessions will begin with a 5 minute warm up of major muscle groups using flexibility exercises and end with a cool down. Sessions will focus on improving static balance in the initial stages, then progress to dynamic balance.
16044185|NCT02566772|Drug|TAS3681|TAS3681 will be provided as 100 mg tablets to be administered orally in 28-day cycles. The number of cycles is approximately 6, or until discontinuation criteria is met.
16044186|NCT02566759|Drug|TAK-831 Oral Suspension|TAK-831 oral suspension.
16044187|NCT02566759|Drug|TAK-831 Placebo|TAK-831 placebo-matching oral suspension.
16044188|NCT02566759|Drug|TAK-831 Tablet|TAK-831 tablet.
16044189|NCT02566746|Device|Chait Trapdoor caecostomie catheter|implantation of the Chait Trapdoor caecostomie catheter
16044190|NCT02566746|Drug|continuation of optimal medical therapy|continuation of treatment with laxative and / or suppositories and / or enemas retrograde At 12 months : implantation of the Chait Trapdoor caecostomie catheter
16044191|NCT02566733|Drug|Remiva|Target controlled infusion of remifentanil (generic drug, Remiva™)
16044192|NCT02566733|Drug|Ultiva|Target controlled infusion of remifentanil (brand-named drug, Ultiva™)
16044193|NCT02566720|Drug|Amantadine|Participants will initially receive amantadine at the starting dose of 50mg twice daily either by mouth or feeding tube. The dosage will increase every week by 50mg twice daily (100mg total dose increase) up to the target dose of 200mg twice daily. These are the usual doses and rate of increase that are offered to patients with brain injury.
16044194|NCT02566720|Procedure|MRI Tractography Study|Participants will initially receive a baseline MRI Tractography scan. The size of RAS fiber tracts will be measured prior to initiating treatment and near the time of discharge from the rehabilitation hospital or at approximately ninety-days.
16044195|NCT02566707|Drug|Atazanavir|HIV therapy will be adapted: atazanavir 400mg QD
16044196|NCT02566707|Drug|Dolutegravir|HIV therapy will be adapted: dolutegravir 50mg QD
16044197|NCT02566707|Drug|Lamivudine|HIV therapy will be adapted: lamivudine 300mg QD
16044198|NCT02566694|Procedure|Implant|orthopaedic implant
16044199|NCT02566681|Biological|MSC construct for Osteonecrosis|"30 days before implanting the construct made with MSC + TP + DBM, bone marrow of patients diagnosed with osteonecrosis of the jaw included in the clinical trial is obtained. The bone marrow will be obtained according to standard practice for Hematologists of the Haematology University Hospital Virgen de la Arrixaca (HCUVA).
~Mononuclear bone marrow cells were separated and cultured in GMP conditions (Good Manufacturing Practices). The cells are seeded on tricalcium phosphate and maintained in culture for 14 days.
~The day when the implant is performed, the patient is prepared in the operating room. The area where the implant will be placed is cleaned. Mesenchymal cells seeded in tricalcium phosphate are mixed with demineralized bone matrix and It's coagulated with autologous platelet rich plasma and grafting is performed. Finally, the oral mucosa or skin will be sealingly closed by silk sutures."
16044200|NCT02566668|Other|1 year Observational Follow-up|Approximately 12 months after research bronchoscopy, subjects will return for follow-up visit.
16044201|NCT02566655|Biological|Fucosylated MSC for Osteoporosis|"Aproximately 30 days before the infusion of the investigational product, patient bone marrow will be obtained according to standard practice of the Haematology University Hospital Virgen de la Arrixaca (HCUVA).
~Mononuclear bone marrow cells will be separated and cultured in GMP conditions to purify and obtain mesenchymal cell established dose range. The infusion day BM-MSCs will be fucosylated and resuspended in saline to a concentration of 5 million cells per 1 mL. Then, the final product will be packaged in syringes for intravenous administration to patients through a peripheral venous access."
16044202|NCT02566642|Other|educational material|pts coming to preadmission testing will view self administered tutorial on the role of anesthesiologist
16044203|NCT02566629|Other|collect faeces from participants|analyze the fecal microbiota community using 16S rDNA detection technique
16044204|NCT02566616|Device|Ulnar Nerve Stimulation|1 hour of continued stimulation of the ulnar nerve using a hand held stimulator
16044205|NCT02566603|Drug|PRTX-100|Four weekly infusions of PRTX-100 at a level of 3 micrograms of PRTX-100 per kilogram of patient weight, infused over 30 minutes, followed by four hours of observation after start of infusion.
16044206|NCT02566603|Drug|PRTX-100|Four weekly infusions of PRTX-100 at a level of 6 micrograms of PRTX-100 per kilogram of patient weight, infused over 30 to 60 minutes, followed by four hours of observation after start of infusion.
16044207|NCT02566603|Drug|PRTX-100|Four weekly infusions of PRTX-100 at a level of 12 micrograms of PRTX-100 per kilogram of patient weight, infused over 60 minutes, followed by four hours of observation after start of infusion.
16044208|NCT02566603|Drug|PRTX-100|Four weekly infusions of PRTX-100 at a level of 18 micrograms of PRTX-100 per kilogram of patient weight, infused over 60 minutes, followed by four hours of observation after start of infusion.
16044209|NCT02566603|Drug|PRTX-100|Four weekly infusions of PRTX-100 at a level of 24 micrograms of PRTX-100 per kilogram of patient weight, infused over 60 minutes, followed by four hours of observation after start of infusion.
16044345|NCT02565628|Drug|PF-06669571|1 milligram (mg) QD for 3 days followed by 3 mg QD for 4 days
16044212|NCT02566590|Dietary Supplement|non-protein placebo supplement|supplement will be used as a placebo to control participants. The supplement will be provided 3x a day during bed rest.
16044213|NCT02566577|Biological|Fresh red blood cell (RBC) transfusion|1 or 2 cross-matched, packed red blood cells (RBC) units from fresh (<10 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit.
16044214|NCT02566577|Biological|Storage-aged red blood cell (RBC) transfusion|1 or 2 cross-matched, packed red blood cells (RBC) units from storage-aged (>21 days old) blood, as ordered by the attending physician, will be given as an intravenous infusion via a programmable electronic infusion pump (Baxter, Inc) over a period of 1 hour per unit.
16044215|NCT02566577|Device|Electronic infusion pump|A programmable, electronic infusion pump (Baxter, Inc) will be used for intravenous transfusion of units of packed red blood cells (RBC). The pump will be programmed to deliver 1 unit of packed RBC per hour.
16044216|NCT02566564|Drug|Lopain|intra-articular injection
16044217|NCT02566551|Procedure|PAE|Embolization of the prostate with gelatin embolization spheres via microcatheterization of the prostatic arteries.
16044218|NCT02566551|Device|Gelatin microspheres|Gelatin embolization microspheres (300-500 microns) will be used as embolic material for the prostatic artery embolization (PAE) protocol
16044219|NCT02566551|Procedure|TURP|Bipolar transurethral resection of the prostate
16044220|NCT02566551|Device|Bipolar electrosurgery generator|A bipolar electrosurgery generator will be used to perform transurethral resection of the prostate (TURP)
16044221|NCT02566525|Device|CytoSorb|Cytosorb device use during cardiopulmonary bypass
16044222|NCT02566512|Other|Tracheostomy cuff inflation.|With the tracheostomy cuff inflated, the peak expiratory flow meter will be attached directly to the tracheostomy tube. The patient will be instructed to take as big a breath as they can and then forcefully cough. This will be repeated four times.
16044223|NCT02566512|Other|Tracheostomy cuff deflation|With the tracheostomy cuff deflated, a one-way valve will be attached to the tracheostomy tube. The patient will use a mouthpiece to connect to the peak expiratory flow meter. The patient will be instructed to take as big a breath as they can and then forcefully cough. This will be repeated four times
16044224|NCT02566499|Device|Breast Microwave Imaging|A Breast Microwave Imaging Procedure will be carried out on volunteers who have abnormal x-ray mammograms, prior to the volunteer undergoing a biopsy to confirm diagnosis (as part of their normal care).
16044225|NCT02566486|Device|Reciprocating system|Different root canal instrumentation systems
16044226|NCT02566486|Device|Rotational system|Different root canal instrumentation systems
16044227|NCT02566460|Other|Resuscitation|First, either crystalloid or colloid could be given to achieve a CVP of 8 to 12 mm Hg. Second, if the mean arterial pressure (MAP) was less than 65 mm Hg, norepinephrine was administrated to maintain MAP ≥65 mm Hg. If the mean arterial pressure was higher than 90 mm Hg, vasodilators were given until it was 90 mm Hg or below. Finally, SCVO2 or lactate clearance will be checked to determine red blood cells transfused or not to achieve a haematocrit of at least 30%. If ScvO2 or lactate clearance remains unmet target value, dobutamine could be used in the treatment.
16044228|NCT02566447|Device|Solana Trichomonas Assay Testing|Specimen collection of urine and/or vaginal swabs for testing
16044229|NCT02566434|Dietary Supplement|methionine|4 weeks intervention and 2 to 4 weeks washout in healthy volunteers with free methionine at 10 mg/kg body weight/day (=requirement), 25 mg/kg body weight/day, 50 mg/kg body weight/day and 100 mg/kg body weight/day.
16044230|NCT02566421|Other|Laboratory Biomarker Analysis|Correlative studies
16044231|NCT02566421|Other|Quality-of-Life Assessment|Ancillary studies
16044232|NCT02566421|Other|Targeted Therapy|Receive treatment based on genomic sequencing
16044233|NCT02566408|Other|One-on-one interview|Undergo one-on-one interview about KAPs towards PA
16044234|NCT02566408|Other|Survey Questions|Complete survey
16044235|NCT02566395|Radiation|Radiation|1,200 cGy, delivered in 8 fractions of 150 cGy bid x 4 days
16044236|NCT02566395|Drug|Cyclophosphamide|Cyclophosphamide 60 mg/kg IV daily x 2 consecutive days
16044237|NCT02566395|Biological|Donor Lymphocyte Infusion (DLI)|DLI containing 1 x 10E8/kg donor T-cells
16044238|NCT02566395|Biological|Haploidentical Stem Cell Transplantation|2-10 x 10E6/kg donor CD34+ selected cells
16044239|NCT02566382|Procedure|arthroscopy arthrodesis of the shoulder|The shoulder surgery will be realized under arthroscopy only
16044240|NCT02566369|Drug|CD5789 (trifarotene) 50μg/g cream|CD5789 (trifarotene) 50µg/g cream applied once daily for 12 weeks.
16044241|NCT02566369|Drug|Placebo cream|Placebo cream applied once daily for 12 weeks
16044242|NCT02566356|Drug|Oxytocin|40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.
16044243|NCT02566356|Drug|Saline Nasal Spray|40 IU of the saline nasal spray will be administered once at the beginning of the visit.
16044244|NCT02566330|Device|EndoBarrier|The device is a 60-cm long, impermeable plastic sleeve that is open at both sides so food can pass through. The sleeve is anchored in the duodenal bulb and extends partially into the jejunum. This way the pancreatic and bile juices will only mix with the food after the sleeve, hereby creating a functional bypass of the duodenum and the proximal jejunum, which causes malabsorption of nutrients.
16044245|NCT02566317|Device|Sit-Stand workstation|Installation of a sit-stand desk at work
16044246|NCT02566317|Behavioral|Move|A multi-level individual, social, environmental, and organizational intervention targeting increases in light-intensity physical activity in the workplace
16044247|NCT02566304|Drug|Fludarabine|Given IV
16044248|NCT02566304|Radiation|Total-Body Irradiation|Undergo TBI
16044249|NCT02566304|Biological|T Cell-Depleted Donor Lymphocyte Infusion|Undergo DLI
16044250|NCT02566304|Drug|Cyclophosphamide|Given IV
16044251|NCT02566304|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo PBSC transplant
16044252|NCT02566304|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo PBSC transplant
16044253|NCT02566304|Drug|Tacrolimus|Given PO
16044254|NCT02566304|Drug|Mycophenolate mofetil|Given IV
16044255|NCT02566291|Device|Success|Success rate and time for insertion
16044346|NCT02565628|Drug|Placebo|Placebo
16044497|NCT02564471|Drug|Doxycycline|FDA approve dosing schedule
16044256|NCT02566278|Other|Upper airway collapsibility (Pcrit)|To measure passive Pcrit, patients sleep with a mask over their nose or nose and mouth, and CPAP is applied using a custom made machine that can rapidly change mask pressures in research setting. The idea is that rapid changes in airway pressure produce a clear step change in airflow that will be observed quickly. In contrast, during clinical titrations, the CPAP machines change pressure much more slowly to help promote patient comfort. Passive Pcrit will be measured using both research and clinical equipment in the same patients and the Pcrit result using clinical CPAP titration equipment will be compared to the gold standard: Pcrit measurement done through research equipment that changes CPAP pressure rapidly.
16044257|NCT02566265|Biological|Fluzone High Dose Vaccine|
16044258|NCT02566265|Biological|Standard of care/Placebo|
16044259|NCT02566252|Drug|PUL-042 Inhalation Solution|PUL-042
16044260|NCT02566252|Drug|Cromolyn Sodium|Pre-treatment
16044261|NCT02566252|Drug|Albuterol sulfate|Pre-treatment
16044262|NCT02566239|Other|Share activity data with care team|Share participant in-home activity data with retirement community care team.
16044263|NCT02566226|Drug|Bupivacaine with normal saline|Isobaric bupivacaine 15 mg + normal saline 0.5 cc
16044264|NCT02566226|Drug|Bupivacaine with intrathecal morphine|Isobaric bupivacaine 15 mg + intrathecal morphine 100 mcg
16044265|NCT02566213|Other|Parabolic flight|
16044266|NCT02566213|Other|Motor skills measurements|"the kinematics measurements of the right hand with a motion analysis system;
~the measurements of forces applied by the hand on the object to be grasped and moved with a 6 degree of freedom force sensor;
~the measurement of position of the moved object with an inductive position encoder."
16044267|NCT02566187|Drug|Fimasartan/Atorvastatin Combination Tablet|
16044268|NCT02566187|Drug|Fimasartan|
16044269|NCT02566187|Drug|Atorvastatin|
16044270|NCT02566135|Device|Tracheal Intubation using I-gel and ventilating bougie|Following general anaesthesia I-gel was inserted. After proper placement . ventilating bougie was inserted. Once it's placement is confirmed I-gel was removed keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie then it (v.bouggie) was removed . Proper placement of endotracheal tube was confirmed by bilateral equal chest excursion and air entry on auscultation, absence of gastric insuffflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for I-gel, ventilating bougie and endotracheal tube.
16044271|NCT02566135|Device|Tracheal Intubation using C-LMA and ventilating bougie|Following general anaesthesia C-LMA was inserted. After proper placement of C-LMA, ventilating bougie was inserted. It's placement was confirmed and C-LMA was removed after deflation of cuff keeping the ventilating bougie in situ. Then appropriate sized endotracheal tube was railroaded over ventilating bougie. It's placement was confirmed by bilateral equal air entry and chest excursion, absence of gastric insufflation sound over epigastrium and 'sine' wave on capnography. Maximum 3 attempts were allowed for C-LMA , ventilating bougie and endotracheal tube.
16044272|NCT02566122|Other|measurements|
16044273|NCT02566109|Diagnostic Test|Fast MRI|The fast MRI is a 10 minute MRI scan that will be used to determine if cardiovascular injury can be detected early while patients are receiving chemotherapy treatment.
16044274|NCT02566096|Drug|transversus abdominis-plane block with local anesthetic 20 ml of bupivacaine 0.5% + 10 mg morphine|compare the analgesic efficacy of transversus abdominis-plane block with bupivicaine with morphine in patients undergoing major abdominal cancer surgery.
16044275|NCT02566083|Device|non-toric intraocular lens|TECNIS One-piece Monofocal Model ZCB00
16044276|NCT02566083|Device|toric intraocular lens|TECNIS One-piece Toric Models ZCT300 or ZCT400
16044277|NCT02566070|Other|Continuous Gastric Feeding|
16044278|NCT02566070|Other|Bolus Gastric Feeding|
16044279|NCT02566057|Biological|PGx testing guided treatment (PGT)|Genecept Assay (GeneceptTM Assay) will provide information on genotypes of genetic variants that are relevant to psychiatric drug response. The provider can use the information to decide on which psychotropic drugs to use.
16044280|NCT02566044|Other|Placebo|Placebo
16044281|NCT02566044|Drug|QBW276|0.3 mg and 1.5 mg strengths
16044282|NCT02566031|Drug|Indacaterol and glycopyrronium (QVA149)|Capsules for inhalation delivered via SDDPI
16044283|NCT02566031|Drug|Tiotropium|Capsules for inhalation delivered via HandiHaler® device
16044284|NCT02566018|Procedure|treatment/medical device|The new treatment algorithm was applied to all patients with proximal humerus fracture as from May 2013 onwards
16044285|NCT02566018|Procedure|standard|The old treatment algorithm was applied to all patients with proximal humerus fracture up to May 2013.
16044286|NCT02566005|Device|misoprostol|25mcg of misoprostol per vagina every 4hours per the standard hospital protocol. Once the cervix becomes favorable or if the patient is in active labor, or if there is no progress for 24 hours, misoprostol administration will be discontinued. Further management of labor will depend on the labor team. (25mcg tablets are not available commercially; a 100mcg table is cut into fourths by the hospital pharmacist).
16044287|NCT02566005|Device|Foley bulb|a foley bulb will be inserted digitally or by direct visualization with the use of a sterile speculum. The foley will be inserted through the internal os and filled with 60cc of normal saline. The catheter will be taped to the patient's inner thigh under gentle traction. When the foley bulb has fallen out (spontaneous expulsion), further management of labor depends on the labor team. If this does not occur, the catheter will be deflated and removed after 24 hours.
16044288|NCT02565992|Biological|CAVATAK|Maximum dose of CVA21 is 3 x 10E+08 TCID50 (about 4.5 x 10E+06 TCID50/kg for a 70-kg patient) by intratumoral administration.
16044289|NCT02565992|Drug|Pembrolizumab|Intravenous pembrolizumab at 2 mg/kg solution.
16044290|NCT02565979|Dietary Supplement|resveratrol|Resveratrol will be given for 6 months, twice daily. One pill, which contains 75 mg of resveratrol, will be provided with lunch, and the other pill, also containing 75 mg will be given with dinner. So in total a dose of 150 mg/day will be given.
16044291|NCT02565979|Dietary Supplement|placebo|A placebo will given for 6 months, twice daily. One pill will be provided with lunch, and the other pill will be provided with dinner.
16044347|NCT02565615|Other|No intervention|Because this is a non-interventional study, there is no intervention here.
16044348|NCT02565602|Other|Ca-41(isotope tracer)|Ca-41 is given orally in the form of (Ca-41)Cl3 in citrate-buffered solution. Tracer will be used to determine parameters of calcium metabolism based on tracer excretion data.
16044292|NCT02565966|Other|Modified Atkins Diet (MAD)|For those in the MAD intervention group, the dietitian trains the patient and family in the preparation and management of this specialized therapy including sick-day guidelines, meal planning, carbohydrate counting and trouble-shooting. Written and verbal education including, but not limited to: recipes, education materials, sample meal plans and carbohydrate counters are provided to the patient during the initial education session. The caregiver/patient is trained in the outpatient setting and the diet is implemented at home with as much email/phone support from the dietician and ketogenic team as the patient needs to successfully maintain the diet. Medications are all changed over to the lowest carbohydrate forms to eliminate excess carbohydrate intake and all patients are started on vitamin supplements to maintain adequate nutrition.
16044293|NCT02565953|Device|Paclitaxel-releasing PTA balloon catheter|
16044294|NCT02565953|Device|PTA balloon catheter|
16044295|NCT02565940|Other|biopsy|
16044296|NCT02565927|Device|Traditional airway stent|process airway stenting
16044297|NCT02565927|Drug|Iodine-125 seeds|process intraluminal brachytherapy
16044298|NCT02565914|Drug|TEZ/IVA|
16044299|NCT02565914|Drug|IVA|
16044300|NCT02565901|Drug|Carboplatin|Given IV
16044301|NCT02565901|Drug|Docetaxel|Given IV
16044302|NCT02565901|Other|Laboratory Biomarker Analysis|Correlative studies
16044303|NCT02565901|Drug|Sirolimus|Given PO
16044304|NCT02565888|Drug|Daclatasvir|
16044305|NCT02565888|Drug|Atazanavir|
16044306|NCT02565888|Drug|Ritonavir|
16044307|NCT02565888|Drug|Cobicistat|
16044308|NCT02565875|Behavioral|SLL Presentation|Educational presentation on the use of a standardized lexicon for communication between surgeon and assistant during laparoscopy
16044309|NCT02565875|Behavioral|Control Presentation|Educational presentation on relevant anatomy related to laparoscopy performed by a gynecologic surgeon.
16044310|NCT02565875|Other|Simulated laparoscopic task|Using a low-fidelity pelvis simulator and laparoscopic instruments, pairs of each arm will be asked to perform a laparoscopic task (maneuver a ball into a nylon surgical bag). Use of SLL will be tabulated and task will be timed.
16044311|NCT02565862|Drug|Daclatasvir|
16044312|NCT02565862|Drug|Metformin|
16044313|NCT02565836|Drug|fixed-dose activated prothrombin complex concentrate|"FEIBA VH 500 units IV one time for INR less than 5. FEIBA VH 1000 units IV one time for INR greater than 5.
~Check INR after infusion and may repeat dose if INR still elevated"
16044314|NCT02565836|Drug|variable-dose inactivated prothrombin complex concentrate|"Kcentra 25 units/kg IV one time for INR less than 4. Kcentra 35 units/kg IV one-time for INR 4 to 6. Kcentra 50 units/kg IV one-time for INR greater than 6.
~Check INR after infusion and may repeat dose if INR still elevated."
16044315|NCT02565823|Other|Exercise bout|Participants will exercise for 45min at 75% of VO2peak
16044316|NCT02565810|Drug|Adalimumab PFS and Pen|
16044317|NCT02565797|Device|DabirAIR alternating pressure overlay|DabirAIR alternating pressure overlay is a dynamic support surface that is placed on top a mattress. The DabirAIR overlay provides periodic pressure relief through the alternate inflation and deflation of air cells.
16044318|NCT02565784|Device|Restylane|Facial tissue augmentation
16044319|NCT02565784|Device|Perlane|Facial tissue augmentation
16044320|NCT02565771|Other|Adapted physical activity|The adapted physical activity is done by Education Physique et Gymnastique Volontaire (EPGV) centres.
16044321|NCT02565758|Drug|ABBV-085|Administered as an intravenous infusion in 28-day dosing cycles.
16044322|NCT02565745|Combination Product|Skin dressing|Pre-determined skin areas at risk for PUs (3 or more, depending on the prevaliing body position, prone, supine or Sims') will be covered. Dressings will be changed every 6-7 days unless found wet/contaminated
16044323|NCT02565745|Other|Moisturizing cream|It will be applied twice a day to the same skin areas as the experimental group
16044324|NCT02565732|Biological|Botulinum toxin type A|Botulinum toxin type A, Dose A, Topical
16044325|NCT02565732|Biological|Botulinum toxin type A|Botulinum toxin type A, Dose B, Topical
16044326|NCT02565732|Biological|Placebo comparator|Placebo, Dose C, Topical
16044327|NCT02565719|Drug|REP 2139-Mg|REP 2139-Mg = magnesium chelate complex of REP 2139
16044328|NCT02565719|Drug|Pegasys|immunotherapy
16044329|NCT02565719|Drug|Viread|HBV RT polymerase inhibitor
16044330|NCT02565719|Drug|REP 2165-Mg|REP 2165-Mg = magnesium chelate complex of REP 2165
16044331|NCT02565706|Behavioral|WIC Fresh Start Program|The intervention is an online lesson to promote farmers' market FV purchases and consumption. The lesson comprises three modules, each consisting of 1) behavior change content presented through a video segment featuring WIC participants, and 2) an interactive activity to build targeted knowledge, attitudes, and skills.
16044332|NCT02565706|Behavioral|Existing Online Health Education|Any of seven existing online WIC health education lessons (lessons are available on breastfeeding, being active, fruits and vegetables, calcium, cholesterol, oral health and iron). The lessons consist of an introductory segment presented with online text and graphics. After reading this material, viewers have the option to complete one of four lesson activities. The activities provide opportunities for viewers to read further on the topic and are designed to reinforce key points of the lesson.
16044333|NCT02565693|Drug|Apixaban|
16044334|NCT02565693|Drug|Aspirin|
16044335|NCT02565693|Drug|Carbasalate calcium|
16044336|NCT02565693|Drug|Clopidogrel|
16044337|NCT02565693|Drug|Dipyridamole|
16044338|NCT02565693|Other|No antithrombotic treatment|
16044339|NCT02565680|Drug|placebo|Xyzall 5mg during 5 days + placebo 40mg during 4 days
16044340|NCT02565680|Drug|prednisone|Xyzall 5mg during 5 days + prednisone 40mg during 4 days
16044341|NCT02565667|Device|KOL|KOL staple was used for rectal anastomosis
16044342|NCT02565667|Device|traditional staple|traditional staple was used for rectal anastomosis
16044343|NCT02565641|Drug|Capecitabine|Capecitabine will be administered orally at 830 mg/m^2 BID (equivalent to a total daily dose of 1660 mg/m^2) as intermittent treatment (given days 1 to 21 q4w).
16044344|NCT02565641|Drug|Gemcitabine|Gemcitabine will be administered at a dose of 1000 mg/m^2 once weekly via IV infusion as intermittent treatment (repeated 4-week cycles of 3 weeks treatment and 1 week rest).
16044498|NCT02564471|Biological|Rabies Vaccine|FDA approve dosing schedule
16044349|NCT02565602|Other|Sr-84 (isotope tracer)|Sr-84 is given orally in the form of (Sr-84)Cl2 in aqueous solution.Tracer will be used to determine parameters of strontium metabolism based on tracer excretion data.
16044350|NCT02565602|Dietary Supplement|Vitamin D|One tablet daily (400IU per tablet)
16044351|NCT02565576|Drug|Placebo|
16044352|NCT02565576|Drug|CFZ533|
16044353|NCT02565563|Other|Eye Movement Desensitisation Reprocessing|The purpose of this study is not to assess the device itself. The new device will seek to measure heart rate variabilty during the administration of the treatment EMDR. It will measure the patients sympathetic nervous systems (anxiety arousal). Previous reseach studies have used Electrocardiography (ECG) and the purpose of this study is to determine whether or not this device will obtain similar findings as ECG has done.
16044354|NCT02565563|Device|HeartMath measuring Heart Rate Variability (HRV)|This small device will be attached to the patients finger to allow their heart rate variability to be measured.
16044355|NCT02565550|Dietary Supplement|low FODMAPs|low FODMAPs means excluding food which contains oligosaccharides.disaccharides,monosaccharides, and polyols
16044356|NCT02565537|Procedure|LASIK|WFG vs. WFO LASIK
16044357|NCT02565524|Other|genetic and phenotypic profile|Genetic and phenotypic profile, clinical and neurocognitive assessment for child with Schizophrenia and autism, their parents and brotherhood
16044358|NCT02565511|Biological|CAD106 Immunotherapy|Participants will be given i.m. injections at Weeks 1, 7, 13 and quarterly i.m. injections (every 13 weeks) thereafter, until the last injection 3 month prior to completion of the Treatment Epoch.
16044359|NCT02565511|Other|Placebo to CAD106|Participants will be given i.m. injections at Weeks 1, 7, 13 and quarterly i.m. injections (every 13 weeks) thereafter, until the last injection 3 month prior to completion of the Treatment Epoch.
16044360|NCT02565511|Drug|CNP520|CNP520 50 mg capsule p.o. for the duration of the Treatment Epoch.
16044361|NCT02565511|Other|Placebo to CNP520|Placebo to CNP520 p.o. for the duration of the Treatment Epoch
16044362|NCT02565511|Other|Alum|Alum was mixed with reconstituted CAD106 as adjuvant therapy to maximize the effectiveness of CAD106
16044363|NCT02565498|Radiation|Preoperative intensity modulated radiation therapy|50 Gy delivered in 25 fractions 4-6 weeks prior to surgical excision
16044364|NCT02565498|Radiation|Postoperative intensity modulated radiation therapy|Surgery followed by 50 Gy delivered in 25 fractions within 6 weeks of surgery for patients with negative margins; for patients with positive margins a boost of 16 Gy in 8 fractions will be added.
16044365|NCT02565485|Drug|Lactated Ringer's|1500 cc of IV Fluid (crystalloid) used for preload prior to epidural administration in the treatment arm. Control arm receives 500 cc.
16044366|NCT02565472|Other|White grape juice|
16044367|NCT02565472|Other|Apple juice|
16044368|NCT02565459|Biological|Mesenchymal Stromal Cells|
16044369|NCT02565446|Device|Magnetic Resolution Elastography|Correlation between histology and MRE with respect to liver fibrosis and inflammation.
16044370|NCT02565446|Procedure|Clinical Cohort|Recruitment will be of patients who are scheduled to visit the GIH liver clinic.
16044371|NCT02565433|Other|questionnaire administration|Within 15 days before radiosurgery and then at 3, 6, 9, 12 months after radiosurgery, the patients who have accepted to participate will have to complete these questionnaires : QLQC30, BN20, IADL, HADS, MoCa, Edmonton Symptom Assessment Scale
16044372|NCT02565420|Other|Normal saline|Patients will be administered normal saline for intraoperative fluid management.
16044373|NCT02565420|Other|Lactated Ringer's solution|Patients will be administered Lactated Ringer's solution for intraoperative fluid management.
16044374|NCT02565407|Behavioral|Proprioceptive training|Training includes a virtual balance board and center-out task. Small vibratory motors placed on forearms provide vibro-tactile movement feedback (VTF). During familiarization participants learn to associate VTF with wrist movement and visual feedback. Vision is occluded after this phase. In the virtual balance board task participants use wrist motion to roll a ball to a target on the board. VTF indicates the desired movement direction and ball velocity. The center-out task involves wrist motion to control a cursor to reach a target. The wrist robot delivers an assistive force towards the target. VTF signals magnitude and direction of the cursor deviating away from the desired path.
16044375|NCT02565407|Behavioral|Usual care|Usual care refers to care that participants receive through their healthcare providers. It may range from no treatment to various sessions of occupational and physical therapy received at in- or outpatient rehabilitation clinics or at home.
16044376|NCT02565394|Other|Micro Break with Dynamic Exercise Activities|Surgeons may elect to activate a web application (video) and perform targeted intraoperative exercises.
16044377|NCT02565381|Drug|Transdermal nicotine patch|"≥10 cigarettes per day: nicotine 21mg/24hr patch daily x 6 weeks, then nicotine 14mg/24hr patch daily x 2 weeks
~<10 cigarettes per day: nicotine 14mg/24hr patch daily x 8 weeks"
16044378|NCT02565381|Behavioral|In-person smoking cessation counseling|- One-on-one 15-minute counseling sessions once per week for 8 weeks
16044379|NCT02565381|Behavioral|Contingent financial rewards for smoking abstinence|- Escalating-value financial rewards for smoking abstinence, verified by exhaled carbon monoxide <8ppm
16044380|NCT02565381|Behavioral|Text messages to support smoking abstinence|- 1-5 text messages per day starting up to 2 weeks before the quit date and continuing until 6 weeks after the quit date, delivered by SmokefreeTXT
16044381|NCT02565368|Drug|Duvie Tab. 0.5mg, Glucophage XR Tab. 1000mg|single oral administration
16044382|NCT02565368|Drug|CKD-395 0.5/1000mg|single oral administration
16044383|NCT02565355|Other|Dietary Exclusion|The IgG antibody results will be disclosed ONLY to the patients in the lifestyle modification group by phone approximately one week after clinic visit.. 'Dietary Exclusion' will be advised by a dietitian. Patients are advised to eliminate a maximum of two foods as identified by high IgG antibody titres.
16044384|NCT02565355|Other|Standard Treatment|The standard therapy group will receive conventional treatment for Abdominal Pain as per usual practice at the Pediatric GI (PG) Clinic - counseling, reassurance, improving coping strategies and pain relievers as appropriate.
16044385|NCT02565342|Procedure|Interscalene brachial plexus block|
16044386|NCT02565316|Drug|Nepeta menthoides Boiss & Bohse freeze dried extract|
16044387|NCT02565316|Drug|Sertraline|
16044388|NCT02565303|Procedure|Intervertebral space|
16044491|NCT02564523|Biological|MVA-BN-Filo|One 0.5 mL IM injection of (1x10*8 infectious units)
16044389|NCT02565303|Drug|Ropivacaine|The initial dose of ropivacaine is chosen as 12 mg in L2-3 group and 15 mg in L3-4 group with the volume of 3 mL in both groups. The testing interval is 0.5 mg with subsequent doses being determined by the outcome of the previous injection in the same group.If the previous response is ineffective, the next patient will receive 0.5 mg more than the last patient. If the response of the previous patient is effective, the next patient decrease 0.5mg.
16044390|NCT02565290|Dietary Supplement|Omega 3|Pregnant women should take 2 capsules of omega 3 (1g), 2 times a day, for 21 days.
16044391|NCT02565290|Dietary Supplement|Soy Oil|Pregnant women should take 2 capsules of placebo 3 - soy oil oil (1g), 2 times a day, for 21 days.
16044392|NCT02565277|Biological|Influenza Vaccine|
16044393|NCT02565277|Drug|Placebo|
16044394|NCT02565264|Other|plasma-derived exosomes|Plasma samples from the participants will be filtered through 0.45 μm and 0.20 μm filters. The samples will be filtered through 0.02 μm filter to trap exosomes with the filter. Saline solution will be loaded from the other side of the 0.02 μm filter to obtain exosome rich buffer. The plasma-derived exosomes will be applied to the participants' ulcers daily for 28 days.
16044395|NCT02565251|Device|Flotrac/Ev1000|Hemodynamic resusucitation guided by the data obtained from the monitorisation with Flotrac/Ev1000 device in the first two hours
16044396|NCT02565251|Device|Standard ICU monitorisation|Hemodynamic resusucitation guided by the data obtained from ICU standard hemodynamic monitoring (BP, CVP) in the first 2 hours
16044397|NCT02565251|Device|VolumeView/Ev1000|Hemodynamic resusucitation guided by the data obtained from the monitorisation with VolumeView/Ev1000 device in the next four hours
16044398|NCT02565238|Device|BioMonitor 2|Implantation of BioMonitor 2
16044399|NCT02565225|Behavioral|RheumaLive App use|
16044400|NCT02565212|Drug|Montelukast,mometazon froat|
16044401|NCT02565199|Device|rTMS over Premotor Cortex (Contralateral Hemisphere)|"Location of rTMS: premotor cortex
~Frequency of rTMS: 0.1 Hz
~Time of rTMS: 50 milliseconds before the onset of movement-related EMG
~Device: MagStim Super Rapid 2 Transcranial Magnetic Stimulator"
16044402|NCT02565199|Device|rTMS over Premotor Cortex (Ipsilateral Hemisphere)|"Location of rTMS: premotor cortex
~Frequency of rTMS: 0.1 Hz
~Time of rTMS: 50 milliseconds before the onset of movement-related EMG
~Device: Super Rapid 2 Transcranial Magnetic Stimulator"
16044403|NCT02565199|Device|rTMS (Control 1)|"Location of rTMS: premotor cortex
~Frequency of rTMS: 0.1 Hz
~Time of rTMS: 400 milliseconds after the onset of movement-related EMG
~Device: Super Rapid 2 Transcranial Magnetic Stimulator"
16044404|NCT02565199|Device|rTMS (Control 2)|"Location of rTMS: somatosensory cortex
~Frequency of rTMS: 0.1 Hz
~Time of rTMS: 50 milliseconds before the onset of movement-related EMG
~Device: Super Rapid 2 Transcranial Magnetic Stimulator"
16044405|NCT02565199|Device|rTMS (Control 3)|"Location of rTMS: premotor cortex
~Frequency of rTMS: 0.1 Hz
~Time of rTMS: 50 milliseconds before the onset of movement-related EMG
~Device: Super Rapid 2 Transcranial Magnetic Stimulator with Sham Coil"
16044406|NCT02565199|Other|Motor Training|During motor training, participants will quickly extend their hand at a pace of one extension every 5 seconds (0.2Hz) in response to an auditory cue.
16044407|NCT02565186|Drug|Lasmiditan|oral tablet
16044408|NCT02565173|Drug|trabodenoson 4.5% BID|Trabodenoson 4.5% administered twice per day in both eyes for 12 weeks.
16044409|NCT02565173|Drug|trabodenoson 6.0% QD|Trabodenoson 6.0% administered once per day in the morning in both eyes followed by matching placebo administered once per day in the evening in both eyes for 12 weeks.
16044410|NCT02565173|Drug|trabodenoson 3.0% QD|Trabodenoson 3.0% administered once per day in the morning in both eyes followed by matching placebo administered once per day in the evening in both eyes for 12 weeks.
16044411|NCT02565173|Drug|timolol 0.5% BID|Timolol 0.5% administered twice per day in both eyes for 12 weeks.
16044412|NCT02565173|Drug|placebo BID|Placebo administered twice per day in both eyes for 12 weeks.
16044413|NCT02565160|Procedure|Intra-articular aspiration of Joint|Procedural sampling of the joint for diagnostic purposes
16044414|NCT02565160|Procedure|Joint irrigation washout|Procedural washout for treatment purposes
16044415|NCT02565160|Procedure|Total Joint Arthroplasty|
16044416|NCT02565160|Procedure|Revision Joint Arthroplasty|
16044417|NCT02565147|Procedure|PPCI|PPCI for treatment of participants presenting with large STEMI.
16044418|NCT02565147|Drug|Bivalirudin|Bivalirudin is an anticoagulant that binds thrombin in a bivalent and reversible fashion and directly inhibits it.
16044419|NCT02565147|Drug|Heparin|Heparin is an anticoagulant.
16044420|NCT02565134|Drug|PAC-14028 cream 0.1%|Topical application
16044421|NCT02565134|Drug|PAC-14028 cream 0.3%|Topical application
16044422|NCT02565134|Drug|PAC-14028 cream 1.0%|Topical application
16044423|NCT02565134|Drug|PAC-14028 cream vehicle|Topical application
16044424|NCT02565121|Drug|corticosteroids|
16044425|NCT02565121|Behavioral|olfactory stimulation|stimulation with odorants by sniffing 4 different odorants for a total of 5 minutes twice a day during 3 months
16044426|NCT02565108|Drug|GWP42003-P 20 mg/kg/Day Dose|GWP42003-P was an oral solution containing 25 mg/mL cannabidiol (CBD) or 100 mg/mL CBD dissolved in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL).
16044427|NCT02565108|Drug|Placebo|Placebo oral solution contained the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL).
16044428|NCT02565108|Drug|Clobazam|Participants were already on a stable dose of CLB at Baseline and continued to take a stable dose of CLB for the duration of the blinded phase of the study. CLB was administered either once or twice daily in line with the physician's preferred dosing regimen for the CLB for each participant.
16044429|NCT02565095|Procedure|Stimulation of the carotid baroreceptors with a pressure system|In each decubitus, trains of stimuli 8 (-80, -60, -40, -20, 0, 10, 20 and 40 Torr), with a duration of 500 milliseconds each, will be applied using a positive and negative pressure system placed around the neck of the subject.
16044430|NCT02565082|Other|Blood sampling - healthy volunteers|Four citrate blood sampling tubes (blue cap, 2.7ml) will be taken only once.
16044431|NCT02565082|Other|Blood sampling - sickle cell patients arm - stable condition|Four citrate blood sampling tubes (blue cap, 2.7ml) will be taken only once.
16044587|NCT02563847|Dietary Supplement|1.56 g L-Tryptophan|
16044432|NCT02565082|Other|Blood sampling - sickle cell patients arm- exsanguinotransfusion needed|Four citrate blood sampling tubes (blue cap, 2.7ml) will be taken only once, before and after the exsanguinotransfusion.
16044433|NCT02565082|Other|Blood sampling - sickle cell patients arm - vaso-occlusive crisis.|Four citrate blood sampling tubes (blue cap, 2.7ml) will be taken only once.
16044434|NCT02565069|Device|CartoFinder™ Device with CARTO® 3 System V5 Navigation|Ablation treatment
16044435|NCT02565056|Other|Self help book + telephone support|Self-help book based upon principles of Acceptance and Commitment Therapy
16044436|NCT02565043|Device|RENASYS TOUCH Negative Pressure Wound Therapy System|RENASYS TOUCH NPWT System was administered to all participants.
16044437|NCT02565017|Behavioral|Focus groups|After the presentation of the of IBM Watson Oncology at the opening of the focus group, participants will be asked to fill out a de-identified brief 15-item questionnaire to assess participants' first impressions of IBM Watson Oncology. The questionnaire will be self administered, and will take approximately 5 minutes to complete. Completed questionnaires will be collected by a member of the study staff, and the focus group will proceed with introductions. The focus group will be audio recorded from the completion of the introductions and notes will be taken. The focus group guide will address the study aims. At the end of the focus group, participants will complete a 7-item questionnaire to capture simple demographic information including education, income, and health literacy. This questionnaire will take 3-5 minutes to complete.
16044438|NCT02564978|Drug|Minocycline|Adult participants will be instructed to take their prescribed IP orally two times a day, once in the morning and once in the evening, approximately 12 hours apart. The capsules will be dispensed to the participant in a tight, light-resistant container as defined in the USP in three month supply aliquots. Starting at Month 9 and continuing at Month 12, a three-month supply will be dispensed to the participant during the study visit or mailed to the participant. Participants will be given an instruction sheet for taking the prescribed IP. Starting at Month 15 participants will receive two bottles for a six-month supply. The IP should be stored between 15-30(degree)C (or 59-86(degree)F). They should be protected from light, moisture, and excessive heat. Participants will be required to bring their bottles of IP to each appropriate visit for capsule counts for compliance monitoring.
16044439|NCT02564965|Device|Double Pigtail Plastic Stent|Patients will be stratified into two arms (Greater than 50% necrosis or less than 50% necrosis), then will be randomized to either the double pigtail plastic stent or AXIOS metal stent
16044440|NCT02564965|Device|AXIOS Metal Stent|Patients will be stratified into two arms (Greater than 50% necrosis or less than 50% necrosis), then will be randomized to either the double pigtail plastic stent or AXIOS metal stent
16044441|NCT02564952|Drug|GWP42003-P|GWP42003-P was presented as an oral solution containing 100 mg/milliliter (mL) cannabidiol (CBD) in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL). Participants received up to a maximum of 30 mg/kg/day.
16044442|NCT02564952|Drug|Clobazam|Participants were taking CLB upon entry into the OLE phase of the trial. CLB was not an investigational medicinal product (IMP) for the OLE phase and was not administered by the Sponsor, but was administered at the physician's discretion, as required for each participant. CLB could be stopped, if clinically indicated, without impact on analysis.
16044443|NCT02564939|Drug|ramelteon|double-blind RCT
16044444|NCT02564939|Drug|Placebo|double-blind RCT
16044445|NCT02564926|Drug|Dapagliflozin|Subject who will be randomized to the 'Dapagliflozin arm' will be treated with dapagliflozin 10mg + Metformin 1000 mg as Diabetes Treatment
16044446|NCT02564926|Drug|Glimepiride|Subject who will be randomized to the 'Glimepiride arm' will be treated with glimepiride 1-2mg + Metformin 1000 mg as Diabetes Treatment
16044447|NCT02564913|Other|clinical evaluation|
16044450|NCT02564887|Device|Iowa Oral Performance Instrument|the IOPI device is being used to increase tongue strength and endurance
16044451|NCT02564874|Other|Discretionary calorie source|We are assigning participants randomly to either of two different sources of discretionary calories (savory snacks or sugary beverages)
16044452|NCT02564861|Drug|DS-1971a|DS 1971a is supplied as a powder or crystals and will be given as an oral suspension
16044453|NCT02564861|Drug|Placebo|Placebo matching DS-1971a suspension
16044454|NCT02564848|Procedure|Lumpectomy without sentinel node biopsy|Biopsy of the sentinel node is considered standard of care treatment for women with localized breast cancer. The procedure will be eliminated at time of lumpectomy.
16044455|NCT02564835|Other|Yoga|The yoga curriculum in this study is based is based on the Integral Yoga approach that includes branches of yoga associated with cognitive and immune benefits (Hatha, Raja). Within the Integral Yoga approach, physical poses, breathing techniques and mediation practices were chosen to provide benefits to the nervous system, immune system, musculoskeletal system and gastrointestinal system. Poses will be adapted to individual needs. The number of repetitions and/or length of hold will be increased through standard progression.
16044456|NCT02564835|Other|Physical Activity|The physical activity intervention is based on the Exercise for People Living with Cancer program. The intervention will include nine resistance exercises (e.g. squats) and 8 flexibility exercises (e.g. shoulder stretch) targeted for the whole body as well as a brief warm up and cool down (walking). Exercises will be adapted to individual needs. The number of repetitions and/or length of hold will increase through standard progression.
16044457|NCT02564822|Procedure|Visual Stimulation|volunteers will be invited to sit in a comfortable chair, in a calm and dark room, at 90 cm of distance from computer screen. It will be asked to fix his right eye visual field on a red point at the center of the screen (the left one will be blindfolded). Visual stimuli will be a black and White grid pattern, alternating at a frequency of 3.1 Hz.
16044492|NCT02564523|Biological|Placebo|One 0.5 mL IM injection of 0.9% saline
16044493|NCT02564497|Biological|Process E Belatacept|
16044494|NCT02564497|Biological|Process C Belatacept|
16044495|NCT02564471|Drug|Chloroquine|FDA approve dosing schedule
16044458|NCT02564809|Behavioral|Fit Brains Training|These hourly classes will consist of cognitive brain training (Fit Brains by Rosetta Stone) on a mobile device (tablet/iPad). Fit Brains offers 60+ different training games, each targeting one of five cognitive domains - executive functions, memory, concentration/attention, visual-spatial ability, and processing speed. Each game lasts exactly 60 seconds during which individuals aim to answer as many questions correctly. The difficulty of the game increases after each correct answer. Each game has three level of difficulty: 1) novice; 2) intermediate; and 3) advanced.
16044459|NCT02564809|Behavioral|Exercise + Fit Brains Training|These classes combine aerobic training and cognitive training. The classes will consist of a 15-minute walk prior to cognitive brain training (Fit Brains by Rosetta Stone) on a mobile device (tablet/iPad). Fit Brains offers 60+ different training games, each targeting one of five cognitive domains - executive functions, memory, concentration/attention, visual-spatial ability, and processing speed. Each game lasts exactly 60 seconds during which individual aims to answer as many questions correctly. The difficulty of the game increases after each correct answer. Each game has three level of difficulty: 1) novice; 2) intermediate; and 3) advanced.
16044460|NCT02564809|Behavioral|Balanced And Tone|These classes will consist of hourly sham training class, hourly classes of sham exercise (e.g., balance, stretching, range of motion), and hourly educational classes.
16044461|NCT02564796|Drug|Epoetin Alfa and Iron|Patients in the treatment group will receive weekly EPO injections and iron supplementation for 6 weeks starting before 8 weeks of age, 1 week after their first procedure (surgery or heart catheterization) They will be followed for 14 weeks.
16044462|NCT02564796|Drug|Iron|Patients in the treatment group will not receive any extra intervention outside of standard of care. They will receive iron supplementation for 6 weeks starting before 8 weeks of age, 1 week after their first procedure (surgery or heart catheterization). They will be followed for 14 weeks.
16044463|NCT02564783|Other|No intervention|No intervention
16044466|NCT02564718|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Body weight adjusted dosing of rivaroxaban to achieve a similar exposure in the range as that observed in adults treated for venous thromboembolism (VTE) with 20 mg once daily.
16044467|NCT02564705|Procedure|Anterior Lumbar Interbody Fusion (ALIF)|
16044468|NCT02564705|Procedure|Posterior Fusion|"Posterolateral Fusion (PLF)
~Posterior Lumbar Interbody Fusion (PLIF)
~Transforaminal Lumbar Interbody Fusion (TLIF)"
16044469|NCT02564679|Procedure|Laparoscopic Sleeve gastrectomy (LSG)|"These patients (no. 20) are assessed by clinical and psychological evaluation (auxological parameters, blood pressure and personal and family history), blood tests (liver function test's (LFT's), uric acid, lipid and gluco-insulinemic profile with oral glucose tolerance test (OGTT)), abdominal ultrasound at time of enrollment.
~They are treated with laparoscopic sleeve gastrectomy associated to lifestyle intervention. Concomitantly to surgical intervention, liver biopsy is performed.
~At 6 and 12 months after LSG the patients are evaluated with laboratory, clinical and echographic assessment. Moreover, one year after LSG liver biopsy is repeated."
16044470|NCT02564679|Behavioral|Lifestyle Intervention|"These patients (no. 20) are assessed by clinical and psychological evaluation (auxological parameters, blood pressure and personal and family history), blood tests (liver function test's (LFT's), uric acid, lipid and gluco-insulinemic profile with oral glucose tolerance test (OGTT)), abdominal ultrasound at time of enrollment.
~They are treated with lifestyle intervention. At 6 and 12 months after enrollment the patients are evaluated with laboratory, clinical and echographic assessment."
16044471|NCT02564666|Other|telephone counseling|regular telephone counseling for compliance and advese event
16044472|NCT02564653|Behavioral|Technical Assistance, training and clinical reminders|Technical Assistance, training and clinical reminders (TTC)
16044473|NCT02564653|Behavioral|TTC+Referral to Community Health Worker|TTC+ referral to a VHW for additional counseling and follow-up
16044474|NCT02564640|Device|videolaryngoscope|patients intubated by using the videolaryngoscope
16044475|NCT02564640|Device|Macintosh laryngoscope|patients intubated by using the Macintosh laryngoscope
16044476|NCT02564627|Procedure|Self-applied patch|An ambulatory self-applied patch will be placed weekly by the patients for PENS of dermatome T6.
16044477|NCT02564627|Procedure|Conventional procedure|PENS of dermatome T6 will be applied by the MD in the Outpatient Clinic.
16044478|NCT02564627|Dietary Supplement|1200 Kcal/day diet|A 1200 Kcal/day diet will be prescribed.
16044479|NCT02564614|Drug|RO7070179|RO7070179 (13 mg/kg/week) will be administered as 2-hour IV infusion.
16044480|NCT02564601|Behavioral|Piano Training|The intervention focuses upon progressively difficult piano performance exercises (repertoire), technique, and finger dexterity exercises.
16044481|NCT02564601|Behavioral|Computer Cognitive Training|The intervention focuses upon progressively difficult perceptual exercises using the Brain Fitness program plus working memory exercises.
16044482|NCT02564588|Drug|Dasotraline|Dasotraline 4, 6, 8mg flexibly dosed once daily
16044483|NCT02564588|Drug|Placebo|Placebo once daily
16044484|NCT02564575|Biological|HPIV3-EbovZ GP Vaccine|Administered intranasally by a VaxINator device
16044485|NCT02564562|Drug|[14C] PF-06463922|Single oral dose of 100mg PF-06463922 + [14C] PF-06463922
16044486|NCT02564549|Procedure|TRUS-guided biopsy|Patients on the TRUS biopsy-based arm will undergo annual systematic biopsies without any MRI staging or guidance.
16044487|NCT02564549|Procedure|mpMRI with targeted biopsy|Patients on the mpMRI- based arm will undergo annual mpMRI surveillance imaging, with image-guided targeted biopsies only as indicated by radiographic findings.
16044488|NCT02564536|Drug|Pacritinib|-Patients should take pacritinib at approximately the same times every day with a glass of water, with or without food.
16044489|NCT02564536|Drug|Decitabine|-From commercial stock
16044490|NCT02564523|Biological|Ad26.ZEBOV|One 0.5 mL intramuscular (IM) injection of (5x10*10 viral particles)
16044499|NCT02564458|Behavioral|Interval Exercise Training/Motivational Accelerometry|During the 5-12 weeks before allogeneic stem cell transplant, the patient will participate in an at home, interval exercise training (IET) program, as well as wear a physical activity tracker, the FitBit Surge, combined with a weekly motivational call, termed Motivational Accelerometry (MA). The combined intervention is referred to as (IET/MA). The first week of the IET program consists of the participants being asked to engage in 30 minutes of aerobic exercise at any intensity for 3-4 days. For weeks two and beyond, patients be asked to undergo 3-4 sessions of IET, consisting of a 5 minute warm-up and five 2-minute intervals, with the goal of reaching 80% MHR, separated by 3 minutes of recovery/light activity in between each interval. Each exercise session is a total of 30 minutes. In addition, each week prior to transplant, the patient will receive a weekly check-in/motivational call from the study staff in order to track progress and motivate the patient to continue participation.
16044500|NCT02564445|Behavioral|Gamification|All participants will be entered with their teammate into a game that includes points and levels
16044501|NCT02564445|Behavioral|Share Data with PCP|Weight and step count data will be shared with the participant's primary care physician
16044502|NCT02564445|Behavioral|Feedback on weight|Participants will use a wireless weight scale to weigh-in at home and receive feedback on weight.
16044503|NCT02564445|Behavioral|Feedback on step counts|Participants will use a smartphone application that uses accelerometers within the phone to track step counts and receive feedback on step counts
16044504|NCT02564419|Device|Medtronic Activa PC+S|Upon consent, the good candidates will undergo surgical screening that includes a full neurological workup and baseline functional assessment. Subjects that demonstrate feasibility for control will undergo surgery for unilateral implantation of the Activa PC+S as well as the implantation of unilateral subdural strip electrodes (Resume II, model 3587A) over the motor cortex. After 24 hour observation in the hospital, subjects will participate in 24 distinct sessions or visits of testing over a 3-6 month period. During these visits, the sensing, decoding of the implanted device (Activa PC+S) as well as the external stimulation components (Bioness H200) and parameters will be tested and benchmarked. Subjects will participate for 24 sessions and continue to participate in the study until the end of life of the device, at which point the subject may elect to undergo an explant at that time.
16044505|NCT02564406|Device|LOW FLOW EXTRACORPOREAL CO2 REMOVAL, PROLUNG ESTOR|
16044506|NCT02564380|Drug|Pembrolizumab|
16044507|NCT02564380|Drug|Placebo|
16044508|NCT02564367|Drug|S-1|"18 cycles S-1, orally administered twice daily D1-14, q 3 wks
~S-1 starting dose: 2 x 30 mg/m^2 body surface area (BSA), D1-14, q 3 wks First dose reduction: 2 x 25 mg/m^2 BSA, D1-14, q 3 wks Second dose reduction: 2 x 20 mg/m^2 BSA, D1-14, q 3 wks"
16044509|NCT02564354|Drug|QR-010|Single-stranded RNA antisense oligonucleotide in isoosmolar solution
16044510|NCT02564341|Behavioral|Collaboration with an IT enabled nurse care manager|The nurse care manager at each site will collaborate with intervention physicians to implement key essential elements of guideline driven care, namely opioid treatment agreements, urine drug testing, random pill counts and periodic checking of on-line Prescription Monitoring Programs. The nurse care manager will use an electronic registry to retrieve pain medication information from the electronic medical record (EMR). Registry data will be collected on the patients of the intervention group providers. The nurse care manager will be able to use the registry to generate reports that will allow him/her to monitor those patients who are receiving opioids for chronic pain.
16044511|NCT02564341|Behavioral|Education and academic detailing|All intervention participants will receive a 60 minute group didactic session by a national expert on opioid prescribing for pain. Physicians will receive two academic detailing sessions, and will be given the option of having a third, booster academic detailing session if desired.
16044512|NCT02564341|Behavioral|Facilitated access to a specialist in addictions|The nurse care manager will encourage and arrange referral of challenging patients with potential abuse or dependence to prescription opioids to an addiction specialist.
16044513|NCT02564328|Genetic|Intravenous stem cell transplantation|Intravenous injection of autologous bone marrow mesenchymal stem cell transplantation
16044514|NCT02564315|Drug|Nicotine Mini-Lozenge for 11 Months|Participants receive up to 11 months of Nicotine Mini-Lozenges as part of this treatment (dosing based on their nicotine dependence as measured when they started the study: 4 mg if they smoked within 30 minutes of waking and 2 mg if they smoked more than 30 minutes after waking, as per the package insert), along with instructions for use.
16044515|NCT02564315|Behavioral|Preparation Phase Behavioral Reduction Counseling|Participants randomized to receive this treatment receive manual-based counseling calls and visits over the course of 11 months. The ultimate goal will be smoking that is reduced in amount and location. Case managers and participants will collaboratively identify a set of steps to progressively reduce smoking. The primary vehicles for change are to encourage substitution of the nicotine mini-lozenge for cigarettes and to reduce the contexts in which smoking occurs. Counseling will counter post-lapse demoralization by emphasizing participants' progress, the value of smoking reduction as a transitional goal, and the critical value of ongoing treatment engagement. Evidence of progress in reduction of smoking, and smoking contexts will be used to build self-efficacy.
16044516|NCT02564315|Behavioral|Preparation Phase Recycling Counseling|Participants randomized to receive this treatment condition will be encouraged to commit to a new quit date as soon as they feel ready. In the counseling sessions, participants will be encouraged to discuss reasons for and concerns about quitting as well as barriers to setting a quit date.
16044517|NCT02564315|Behavioral|Preparation Phase Control Treatment|Participants randomly assigned to the Preparation Phase Control Treatment condition will continue to receive the Initial Cessation usual care treatment (8 weeks of nicotine patch; two coaching sessions), but will also be told that they can receive additional treatment at no cost from the Wisconsin Tobacco Quitline (WTQL).
16044518|NCT02564315|Behavioral|Cessation Phase Supportive Counseling|Supportive Counseling will be consistent with the Public Health Service (PHS) Clinical Practice Guideline (Fiore et al., 2008) and will involve encouragement, a focus on short-term goals, discussion of participant values (what the participant feels would be good and healthy for them in the long run) and how these values are congruent with cessation, emphasis on the patient and the counselor being a team, encouragement for the participant to generate a quitting strategy with the message that smokers often have a good sense of what will work for them, and prompts for the participant to explore his/her feelings about quitting and feelings of optimism and concern (i.e., to use the counselor as a sounding board).
16044519|NCT02564315|Behavioral|Cessation Phase Skill Training Counseling|"Skill training Counseling will: 1) carefully assess smoking cue contexts and opportunities to smoke, to identify problems encountered in the prior quit attempt; 2) develop specific plans for avoiding such contexts and identify skills for coping with them; 3) develop plans for negotiating with others who smoke; 4) develop lifestyle changes to reduce future smoking opportunities and contexts; and 5) assign homework and assess execution of assigned skills. Participants will receive coping menus that provide personalized coping/avoidance options and coping reports that assess coping execution over time and troublesome contexts and cues around which counseling will be focused. There will be praise for any progress and a collaborative determination of barriers to skill execution."
16044520|NCT02564315|Behavioral|Cessation Phase Brief Information|Participants randomized to receive Brief Information will receive brief (generic) information about the importance of taking the cessation medication, how to use the medication, information about side effects/safety, and what to do in case of problems, and will also be given encouragement to quit smoking.
16044521|NCT02564315|Drug|Cessation Phase Nicotine Patch + Nicotine Mini-Lozenge|All participants will receive 8-weeks of combination NRT (nicotine patch + nicotine mini-lozenge). Nicotine patch dosing will be based on current cigarettes smoked per day, per package insert: for those who currently smoke >10 cigs/day=4 weeks of 21 mg, 2 weeks of 14 mg, and 2 weeks of 7 mg nicotine patches, along with nicotine mini-lozenges; for those who currently smoke <=10 cigs/day=6 weeks of 14 mg and 2 weeks of 7 mg nicotine patches along with mini-lozenges. Mini-lozenge dosing will be based on how soon participants currently smoke after waking before their initial quit attempt and will be consistent with the package insert (4 mg for participants who smoke within 30 minutes of waking and 2 mg for participants smoke more than 30 minutes after waking).
16044522|NCT02564302|Device|MUSE Headband|MUSE Headband will help patients with mindfulness.
16044523|NCT02564276|Procedure|Sentinel lymph node biopsy|
16044524|NCT02564263|Biological|pembrolizumab|IV infusion
16044525|NCT02564263|Drug|paclitaxel|IV infusion
16044526|NCT02564263|Drug|docetaxel|IV infusion
16044527|NCT02564263|Drug|irinotecan|IV infusion
16044528|NCT02564237|Biological|StreptAnova™ (Group A streptococcal (GAS) vaccine)|StreptAnova™ vaccine - 30-valent plus Spa group A Streptococcal vaccine
16044529|NCT02564237|Biological|Hepatitis B vaccine|Participants will indicate which vaccine they wish to receive (Hepatitis B, Hepatitis A, or Human Papillomavirus vaccine) if they are randomized to a comparator prior to randomization.
16044530|NCT02564237|Biological|Hepatitis A vaccine|Participants will indicate which vaccine they wish to receive (Hepatitis B, Hepatitis A, or Human Papillomavirus vaccine) if they are randomized to a comparator prior to randomization.
16044531|NCT02564237|Biological|Human Papillomavirus vaccine|Participants will indicate which vaccine they wish to receive (Hepatitis B, Hepatitis A, or Human Papillomavirus vaccine) if they are randomized to a comparator prior to randomization.
16044532|NCT02564224|Procedure|Pursestring Wound Closure|Procedure: Pursestring Wound Closure
16044533|NCT02564224|Procedure|Conventional Wound Closure|Procedure: Conventional Wound Closure
16044534|NCT02564224|Device|prolene|
16044535|NCT02564211|Drug|Ipragliflozin|one 50 mg tablet QD
16044536|NCT02564211|Drug|Sitagliptin|one 50 mg tablet QD
16044537|NCT02564198|Drug|Ramucirumab|Administered IV
16044538|NCT02564185|Other|Usual practice|
16044539|NCT02564185|Other|Education program|
16044540|NCT02564172|Device|CMS group|"Conus medullaris stimulation with pentapolar surgical lead includes:
~Pentapolar surgical lead implant ((TM)Penta lead from St Judes Medical ANS which is the medical device under study)
~Test phase of 10 days according to HAS(Haute Autorité de Santé) recommendation
~If test phase positive, the lead is kept and subcutaneous rechargeable generator is implanted.
~If test phase negative, the lead is removed.
~Optimal medical management : Similarly to patients randomized in active comparator group, patients randomized in experimental group will also be prescribed optimized medical management (treatment for pain relief) under algologist control.
~(A decrease of the consumption of pain treatment should be observed if conus medullaris stimulation has a positive effect)."
16044541|NCT02564172|Other|OMM group|"Optimal Medical Management (treatment for pain relief) includes analgesics and/or antidepressant and/or antiepileptics.Usually, drugs for neuropathic pain are prescribed as follows:
~at effective dose, and minimal effective dose on the basis of adverse events and contraindications
~as alone treatment in first and second line, then combination treatment. All this depends on the patient, on her/his pain, on her/his previous treatment.
~Medical treatment prescription will reviewed by algologist at each clinical visit. It is not possible in this indication to establish a standardized treatment.
~Non drugs therapies (physiotherapy, psychobehavioral approaches…) will not be forbidden or contra-indicated."
16044542|NCT02564159|Other|Measure of quadriceps thickness with ultrasonography and albumin/prealbumin levels|"Evaluation of quadriceps diameter on the anterior aspect of the thigh using the mid-distance between the anterior superior iliac spine and the upper pole of the patella ;
~Biospecimen collection: Blood samples (prealbumin levels, C-reactive protein, Interleukin-1, Interleukin-6, TNF-alpha and PATROL test™)collection of albumin and prealbumin levels"
16044543|NCT02564146|Drug|nab-paclitaxel and gemcitabine|"Induction treatment:
~3 cycles nab-paclitaxel and gemcitabine 125 mg/m^2, IV infusion over 30 minutes, followed by gemcitabine 1000 mg/m^2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle.
~Continouous treatment after randomization:
~Continuing application of nab-paclitaxel and gemcitabine treatment cycles until progression or unacceptable toxicity. Duration of each cycle is 28 days nab-paclitaxel 125 mg/m^2, IV infusion over 30 minutes, followed by gemcitabine 1000 mg/m^2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle."
16044544|NCT02564146|Drug|gemcitabine mono and nab-paclitaxel and gemcitabine|"Induction treatment:
~3 cycles nab-paclitaxel and gemcitabine 125 mg/m^2, IV infusion over 30 minutes, followed by gemcitabine 1000 mg/m^2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle.
~Continouous treatment after randomization:
~Alternating application of gemcitabine monotherapy and nab-paclitaxel and gemcitabine treatment cycles until progression or unacceptable toxicity, starting with a treatment cycle of gemcitabine monotherapy.
~Duration of each cycle irrespective of treatment cycle with gemcitabine monotherapy or treatment with nab-paclitaxel/gemcitabine is 28 days.
~Gemcitabine monotherapy treatment cycle: Gemcitabine 1000 mg/m^2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle.
~Nab-paclitaxel and gemcitabine treatment cycle: Nab-paclitaxel 125 mg/m^2, IV infusion over 30 minutes, followed by gemcitabine 1000 mg/m^2 as a 30-minute IV infusion; D1, D8, D15 of each 28-day cycle."
16044545|NCT02564133|Device|Transthoracic echocardiography|A transthoracic echocardiography is performed to discover a patent foramen ovale
16044546|NCT02564107|Drug|Ibandronate|Participants will receive ibandronate, 50 milligrams (mg) by mouth every morning, for a period of 25 weeks.
16044547|NCT02564094|Drug|Epoetin beta|Participants will receive SC epoetin beta as 30,000 international units (IU) once weekly for 20 weeks.
16044548|NCT02564081|Other|Static Stretching lower limb|
16044549|NCT02564081|Other|Static stretching Cervical|
16044550|NCT02564068|Drug|Oxytocin|"To test that intranasal oxytocin administration blunts the deleterious hypoxia/hypercapnia induced changes in heart rate that occur during nocturnal apnea in patients with OSA, we will examine the changes in heart rate in a group of patients that have recently been diagnosed with OSA. Ten subjects that have recently undergone a standard in the sleep-lab diagnostic polysomnography (per standard of care medical guidelines, and not for research purposes) and have been diagnosed with OSA will be recruited into a study to assess the beneficial effects of oxytocin treatment."
16044551|NCT02564068|Drug|Placebo|Group B is a crossover study, where subjects will be randomized to receive either placebo or active drug on their first visit, and then the opposite intervention on their second visit.
16044552|NCT02564055|Drug|GSK2894512 1% Cream|1.0% (10 mg/g) GSK2894512 will be supplied as white to off-white cream to be applied topically
16044553|NCT02564055|Drug|GSK2894512 0.5% Cream|0.5% (5 mg/g) GSK2894512 will be supplied as white to off-white cream to be applied topically
16044554|NCT02564055|Drug|Vehicle cream|White to off-white vehicle cream base to be applied topically
16044555|NCT02564042|Drug|GSK2894512 1% Cream|1.0% (10 mg/g) GSK2894512 will be supplied as white to off-white cream to be applied topically
16044556|NCT02564042|Drug|GSK2894512 0.5% Cream|0.5% (5 mg/g) GSK2894512 will be supplied as white to off-white cream to be applied topically
16044557|NCT02564042|Drug|Vehicle cream|White to off-white vehicle cream base to be applied topically
16044558|NCT02564029|Drug|PF-06372865|Single dose
16044559|NCT02564029|Drug|Placebo|Placebo for PF-06372865 and placebo for lorazepam
16044560|NCT02564029|Drug|Lorazepam|2 mg single oral dose
16044561|NCT02564016|Drug|Normal Saline Infusion|Group 2 (treatment) will have an epidural infusion initiated with preservative-free normal saline at a continuous rate of 4ml/hour
16044562|NCT02564016|Other|Capped Epidural|epidural will be capped with no saline infusion.
16044563|NCT02564003|Drug|Oxycodone|oxycodone 0,1 mg/kg iv
16044564|NCT02563990|Procedure|High Pressure Injection|Adductor canal block performed at greater than 20 psi injection pressure
16044565|NCT02563990|Procedure|Low Pressure Injection|Adductor canal block performed at less than 15 psi injection pressure
16044566|NCT02563977|Device|2 year postop CT scan of the abdomen|CT scan of the abdomen (from the xiphoid process to the symphysis) performed approximately two years after performed DIEP flap breast reconstruction. No contrast used. Low dose of radiation.
16044567|NCT02563951|Drug|GNS Spray 0.5mg|
16044568|NCT02563951|Drug|GNS Spray 1.0mg|
16044569|NCT02563951|Drug|GNS Spray 2.0mg|
16044570|NCT02563951|Drug|Kytril 1mg (IV injection)|
16044571|NCT02563951|Drug|Kytril 1mg (Tablet)|
16044572|NCT02563938|Drug|AK001|Given parenterally.
16044573|NCT02563938|Drug|Placebo|
16044574|NCT02563925|Radiation|Brain radiotherapy or Stereotactic Radiosurgery|
16044575|NCT02563925|Drug|Tremelimumab|
16044576|NCT02563925|Drug|HER2 directed therapy|
16044577|NCT02563925|Drug|Durvalumab|
16044578|NCT02563912|Other|Handbook|Resuscitation handbook who provides drug dosages for each weight for children. For example, at the page of 15 kg, it is written that the dosage of epinephrin is 1.5 cc of 1: 10 000.
16044579|NCT02563912|Other|Medication chart|Medication chart who provides drug dosages for each weight for children. For example,it is written that the dosage of epinephrin is 0.01 mg/kg.
16044580|NCT02563899|Drug|Umeclidinium|Umeclidinium (GSK573719) 1.85% will be supplied as a clear, colorless solution, free from visible particulates, for topical application. This formulation will be available at a concentration of 18.5 milligrams (mg) umeclidinium parent per gram. 2 mg of this formulation will be applied per square centimeter of the axilla, once a day at night before going to bed for 14 days. The total amount of formulation applied daily to both axillae is expected to range between approximately 204 and 680 mg. Total daily dosage of the active pharmaceutical ingredient (umeclidinium parent) to both axillae will range between approximately 3.8 and 12.6 mg. If certain pre-specified criteria for safety and tolerability are met, consideration will be given to decreasing the dose by decreasing the concentration of the topical formulation to 1.15% for the remaining subjects. This lower strength formulation will contain 11.5 mg parent per gram.
16044581|NCT02563899|Drug|Vehicle|The vehicle will be supplied as a clear, colorless solution, free from visible particulates, for topical application. This formulation will be similar to the umeclidinium formulation except that it will be devoid of the umeclidinium parent. 2 mg of the vehicle will be applied per square centimeter of the axilla, once a day at night before going to bed for 14 days. The total amount of vehicle applied daily to both axillae is expected to range between approximately 204 and 680 mg.
16044582|NCT02563886|Other|Electrically Assisted Movement Therapy|Electrically Assisted Movement Therapy (EAMT) is an extension of conventional Constraint-Induced Movement Therapy (CIMT) for moderately-to-severely paralyzed patients. During EAMT, patients use a movement controller with the healthy hand, controlling movements generated through neuromuscular electrical stimulation of the paralyzed arm and hand. During each session three types of exercises can be performed: mobilization, games, and training for activities of daily living, all three involving proper shaping of exercise difficulty at therapist discretion. Therapy consists in 20 sessions of 45 minutes twice per day over five weeks.
16044583|NCT02563886|Other|Usual and customary care|Usual and customary care ranges from no treatment to varying amounts of orthotics, home-based and clinic-based occupational therapy, or physiotherapy, but always excludes CIMT and EAMT. Therapy consists in 20 sessions of 45 minutes twice per day over five weeks, whenever possible, to match EAMT amount of therapy.
16044584|NCT02563873|Device|Tailored pacemaker settings|Tailored pacemaker settings, optimised for cardiac contractility: Pacemaker settings, optimised for cardiac contractility as determined by echocardiography, will be programmed
16044585|NCT02563860|Drug|Lovastatin|dose escallating
16044586|NCT02563847|Dietary Supplement|0.52 g L-Tryptophan|
16044593|NCT02563847|Other|50 mg 13C-sodium acetate|
16044594|NCT02563834|Drug|thiapalmitate tracer|Radiolabeled tracer infusion; occurs in all treatment arms
16044595|NCT02563834|Drug|Saline|Saline infusion for control
16044596|NCT02563834|Drug|Insulin|Insulin infusion for insulin/glucose clamp procedure
16044597|NCT02563821|Procedure|Patient Controlled Epidural Analgesia for third trimester termination of preganancy analgesia|
16044598|NCT02563821|Drug|Levobupivacaine|
16044599|NCT02563821|Drug|sufentanil|
16044600|NCT02563821|Drug|clonidine|
16044601|NCT02563821|Device|epidural catheter|
16044602|NCT02563808|Other|Standard Decision Aid|Females will receive standard decisions aid for early stage breast cancer.
16044603|NCT02563808|Other|Post-surgical Regret Decision Aid|Females will receive anticipated regret-augmented version for early breast cancer.
16044604|NCT02563795|Drug|Bupivacaine|To compare low dose spinal anesthesia with bupivacaine alone if it can maintain surgical anesthesia during cesarean section in obese and non-obese pregnants
16044605|NCT02563795|Drug|Fentanyl|To compare low dose spinal anesthesia with bupivacaine+ fentanyl alone if it can maintain surgical anesthesia during cesarean section in obese and non-obese pregnants
16044606|NCT02563782|Biological|Sub-retinal transplantation of MA09-hRPE cells|transplantation
16044607|NCT02563782|Drug|tacrolimus and mycophenolate mofetil|Immunosuppressive Agents
16044608|NCT02563782|Drug|Placebo tacrolimus and mycophenolate mofetil|placebo
16044609|NCT02563782|Procedure|Sham Surgery|Sham surgery
16044610|NCT02563769|Drug|Clavulanic acid|
16044611|NCT02563769|Drug|Intravenous cocaine|
16044612|NCT02563769|Drug|Placebo|
16044613|NCT02563756|Procedure|Unicompartmental knee replacement|Participants with a medial gonarthritis are operated with a medial unicompartmental prosthesis
16044614|NCT02563756|Procedure|Total knee replacement|Participants with a medial gonarthritis are operated with a total knee replacement
16044615|NCT02563743|Behavioral|Problem-solving based intervention|The intervention comprises both the employee and the employer, and follows a clear structure comprising problem solving, stepwise activation and relapse prevention. It includes three meetings at the OHS with additional follow-ups.
16044616|NCT02563743|Behavioral|Treatment as usual|Study participants that are randomized into the control group will receive the usual care given at the OHS. This intervention will differ due to differences between the OHS units.
16044617|NCT02563730|Procedure|Lung biopsy|transbronchial lung biopsy. First kryobiopsy, second open biopsy
16044618|NCT02563717|Device|T-piece used for respiratory support (several manufacturers)|Infants will receive support by a standard T-piece resuscitator system (manufacturer not dictated in protocol). Apart from the system used for respiratory support all patients will receive standard care (specified in management protocol)
16044619|NCT02563717|Device|New system used for respiratory support|Infants will receive support by the new system (manufactured by Inspiration Healthcare, UK). Apart from the system used for respiratory support all patients will receive standard care (specified in management protocol)
16044620|NCT02563704|Drug|Artesunate|
16044621|NCT02563704|Drug|Quinine|
16044622|NCT02563691|Radiation|stereotactic radiotherapy|"Patients will receive ADT for a minimum of 1 year. After this, an intermittent hormone therapy approach will be taken.
~The prostate (if not previously treated) will be treated to a dose of 35-40 Gy in 5 fractions. All visible nodal metastases will be treated to a dose of 30-35 Gy in 5 fractions. Non-spine bone metastases will be treated to a dose of 30-40 Gy in 5 fractions. Metastases in the brain, spine, lung, liver, and adrenal will be treated according to established SRT policies at the Sunnybrook Odette Cancer Centre. Comprehensive SRT should be delivered within 3 months of starting ADT."
16044623|NCT02563678|Drug|Hyperbaric Oxygen|Hyperbaric oxygen therapy
16044624|NCT02563678|Other|Hyperbaric Air/Oxygen|Breathing air inside a hyperbaric chamber, then breathing oxygen inside a hyperbaric chamber
16044625|NCT02563678|Other|Normobaric oxygen|Breathing 100% oxygen at normal, atmospheric pressure
16044626|NCT02563613|Behavioral|Physical Exercise (PE)|Core session: 2 hours, Booster session: 1 hour
16044627|NCT02563613|Behavioral|Healthy Diet (HD)|Core session: 2 hours, Booster session: 1 hour
16044628|NCT02563613|Other|Wait-list Control (C)|The wait-list control group will receive the intervention at 3 months.
16044629|NCT02563600|Behavioral|Pre-letter telephone call.|A brief 2-10 min telephone call made to the patient prior to receipt of appointment invitation letter.
16044630|NCT02563600|Behavioral|Post-letter telephone call|A brief 2-10 min telephone call made to the patient after receipt of appointment invitation letter.
16044631|NCT02563587|Other|Laughter therapy|Laughter therapy sessions will begin as soon as / after that the complete anesthesia recovery, then we could start with two interventions, each of them in morning and during the afternoon will be held until their discharge lasting 30 minutes per each one, these sessions will be held in the service pediatric hospital by trained personnel in laughter therapy, which will be implemented through hospital clowns.
16044632|NCT02563587|Other|Accompaniment without causing the laughter of children.|The interventions will be carried out by means of reading stories and own stories for the age. These sessions will begin subsequent to the full recovery of the anesthesia, and then two interventions per day, in the morning and evening, with duration of 30 minutes, until the time of his discharge, these sessions will take place in the service of Hospital pediatrics by the resident in charge.
16044633|NCT02563587|Drug|Conventional treatment|Conventional treatment involves handling analgesic with non-steroidal anti-inflammatory drugs (paracetaol, metamizol and ketorolac) as prescribed by the doctor surgeon treating, which starts immediately in the postoperative period.
16044634|NCT02563574|Behavioral|Motivational Interviewing|A type of counseling aimed at reducing consumption of alcohol.
16044635|NCT02563574|Other|Questionnaire assessment|Several different types of questionnaires will be fill out by the participants.
16044636|NCT02563574|Other|Neurocognitive assessments|Several different types of neurocognitive assessment will be performed.
16044637|NCT02563574|Other|Blood specimens|Blood specimens will be used to measure the immunological, virologic, and hepatic status, as well as other biomarkers.
16044843|NCT02562157|Device|NOTES gastroenteric anastomosis|
16044640|NCT02563548|Drug|PEGPH20|PEGPH20 will be administered as an intravenous (IV) infusion as per the dose schedule specified in the arm description.
16044641|NCT02563548|Drug|Pembrolizumab|Pembrolizumab will be administered as an IV infusion as per the dose schedule specified in the arm description.
16044642|NCT02563535|Device|DEB|angioplasty with Litos drug eluting balloon
16044643|NCT02563535|Device|PTA|angioplasty with conventional balloon
16044644|NCT02563522|Genetic|VM202|gene therapy
16044645|NCT02563522|Drug|Placebo|Standard of care plus placebo
16044646|NCT02563509|Biological|HIV-specific CD8 cells|Based on HAART, receive HIV-specific CD8 cells transfuion.
16044647|NCT02563496|Drug|Tafenoquine|Tafenoquine tablet is supplied as film-coated tablet (100 mg, 150 mg, 200 mg and 300 mg) and fast-dispersing film coated tablet (50 mg).
16044648|NCT02563496|Drug|Chloroquine|Subjects may receive chloroquine according to local/national treatment guidelines.
16044649|NCT02563483|Behavioral|yoga and compassion meditation program|25 min of physical exercise, holding each pose (stretching exercise) for an average of 1 min and 30 s; 25 min of breathing exercises and 25 min of meditation.
16044650|NCT02563457|Other|periodontal manual treatment|periodontal manual treatment
16044651|NCT02563457|Other|no periodontal manual treatment|blood sampling
16044652|NCT02563444|Device|Ultrasound fusion guiding system - TUS A-500 (Aplio 500)|
16044653|NCT02563431|Device|SYSTAM - SP-ED|"Positioning in bed, wheelchair and standing with classics materials (pillow, holds, sling) on day J0 until J7 or Exit.
~Daily passive mobilisation of the upper member by a therapist.
~Be careful of shoulder's coaptation in care and functional activities (toilet, dressing, transfers)"
16044654|NCT02563431|Device|Ultrasling ER 15°Donjoy - 4P-ED|"Positioning in bed, wheelchair and standing with specific materials (holds, sling in external rotation and abduction) on day J0 until J7 or Exit.
~A training of the patient and members of family on pathology, risk, use of material
~Daily passive mobilization of the upper member by a therapist.
~Be careful of shoulder's coaptation in care and functional activities (toilet, dressing, transfers) and active patient training for use the other side for support hemiplegic shoulder to prevent diastasis."
16044655|NCT02563418|Device|Eye-tracking|
16044656|NCT02563405|Drug|Doxazosin|Doxazosin was given orally in a dose of 4 mg/day to treat patients in the doxazosin group for 12 weeks.
16044657|NCT02563405|Drug|Nifedipine|Nifedipine was given orally in a dose of 30 mg/day to treat patients in the amlodipine group for 12 weeks.
16044658|NCT02563392|Procedure|uterine myomectomy with preventive uterine arteries occlusion|laparoscopic uterine myomectomy with preventive uterine arteries occlusion
16044659|NCT02563392|Procedure|laparoscopic uterine myomectomy without preventive uterine arteries occlusion|laparoscopic uterine myomectomy
16044660|NCT02563366|Other|BM-MSCs|BM-MSCs are from third-party healthy volunteer donors.
16044661|NCT02563366|Other|Saline|Saline is the placebo of MSCs in this study.
16044662|NCT02563353|Other|whole-body vibration|"Whole-body vibration on vibration platforms. 30-40 Hertz, from 2 mm (low) to 4 mm (high) amplitude,
~1 minutes x 6 with 1 minute break between. 3 times a week."
16044663|NCT02563353|Drug|teriparatide|Teriparatide, 20 microgram/day. 24 months of treatment.
16044664|NCT02563340|Other|BM-MSCs|BM-MSCs are from third-party healthy donors, and have no HLA alleles similar to renal allograft donors or reacting to positive anti-HLA antibodies in recipients.
16044665|NCT02563340|Other|Desensitization therapy (PP, IVIG, rituximab or Bortezomib)|At least one drug or treatment is applied as desensitization therapy to decrease DSA, reduce B cells or inhibit plasma cells, depending on individual condition.
16044666|NCT02563327|Drug|Rifapentine|A rifamycin with activity against Mycobacterium tuberculosis
16044667|NCT02563327|Drug|Moxifloxacin|A fluoroquinolone
16044668|NCT02563327|Drug|Rifampin|A rifamycin with activity against Mycobacterium tuberculosis
16044669|NCT02563327|Drug|Isoniazid|An anti-tuberculosis agent
16044670|NCT02563327|Drug|Pyrazinamide|An anti-tuberculosis agent
16044671|NCT02563327|Drug|Ethambutol|An anti-tuberculosis agent
16044672|NCT02563327|Dietary Supplement|Pyridoxine|An essential vitamin
16044673|NCT02563314|Device|Non-invasive mechanical ventilation - Normoxia|Maintenance of an oxygen setting allowing normal oxygen saturation during non-invasive mechanical ventilation (SpO2 targeted 96-98%)
16044674|NCT02563314|Device|Non-invasive mechanical ventilation - Controlled hypoxemia|Maintenance of an oxygen setting allowing mild hypoxemia during non-invasive mechanical ventilation (SpO2 targeted 88-92%)
16044675|NCT02563301|Device|Laryngoscopy|After establishing full monitoring, inducing general anaesthesia and ensuring paralysis, laryngoscopy is performed and the patient's trachea is intubated.
16044676|NCT02563288|Drug|Esmolol|effect of esmolol on intraoperative sympathetic control and on extubation conditions.
16044677|NCT02563288|Drug|Dexmedetomidine|effect of dexmedetomidine on intraoperative sympathetic control and on extubation conditions.
16044678|NCT02563275|Other|motion analysis system|
16044679|NCT02563275|Other|parabolic flight|
16044680|NCT02563262|Other|body angles measurements during weightlessness|
16044681|NCT02563249|Other|Parabolic flight|
16044682|NCT02563249|Other|movements of the upper limb, the gripping force, muscle activity and eye-cephalic subject movement measurements|
16044683|NCT02563236|Other|Parabolic flight|
16044684|NCT02563223|Other|Parabolic flight|
16044685|NCT02563223|Device|Subject Loading System|a device that combines a force platform on which the subject jumps and a Subject Loading System (SLS) that pulls the subject downwards.
16044686|NCT02563210|Other|airway resistance measurement|assessment of airway resistance
16044687|NCT02563197|Device|T-326 Inhaler|No drug dosing,three test inhalations through the inhaler device filled with an empty capsule.
16044688|NCT02563184|Biological|Fluzone|
16044689|NCT02563171|Other|non surgical periodontal treatment|"SRP under local anaesthesia, in a total of 2-3 clinical visits.
~Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush."
16044964|NCT02561338|Drug|HMS5552|50mgBID
16044690|NCT02563171|Other|Gingival crevicular fluid collection|GCF collection with filter paper (Periopaper) using the intracrevicular method.
16044691|NCT02563158|Procedure|non-occlusion technique|Hepatectomy is carried out without hepatic inflow control. (non-occlusion technique)
16044692|NCT02563145|Behavioral|Real-time fMRI feedback|feedback about activation patterns in brain regions related with instrumental aggression
16044693|NCT02563145|Behavioral|Treatment as usual|Psychoeducation, general counselling
16044694|NCT02563132|Procedure|Carbon dioxide insufflation|Carbon dioxide insufflation during diagnostic colonoscopy
16044695|NCT02563119|Procedure|Gastric Bypass or Sleeve gastrectomy|
16044696|NCT02563106|Drug|SYN-004|
16044697|NCT02563106|Drug|Placebo|
16044698|NCT02563093|Biological|Fluzone Quadrivalent vaccine, 2015-2016 formulation, No Preservative|0.5 mL, Intramuscular (IM)
16044699|NCT02563093|Biological|Fluzone Intradermal Quadrivalent vaccine, 2015-2016 formulation|0.1 mL, Intradermal
16044700|NCT02563093|Biological|Fluzone Quadrivalent vaccine, 2015-2016 formulation, No Preservative|0.5 mL, Intramuscular
16044701|NCT02563093|Biological|Fluzone High-Dose vaccine, 2015-2016 formulation|0.5 mL, Intramuscular
16044702|NCT02563067|Drug|QAW039|QAW039 150 mg once daily
16044703|NCT02563067|Drug|QAW039|QAW039 450 mg once daily
16044704|NCT02563067|Drug|Placebo|Placebo once daily
16044705|NCT02563054|Drug|5-Fluorouracil|Participants will receive 5-FU, 800 milligrams per meter-squared (mg/m^2) per day via IV infusion during Days 1 to 5 of each 3-week cycle, for a total of 6 cycles in combination with cisplatin or upto disease progression.
16044706|NCT02563054|Drug|Capecitabine|Participants will receive oral capecitabine, 1000 mg/m^2 twice daily on Days 1 to 14 of each 3-week cycle, for a total of 6 cycles in combination with cisplatin or upto disease progression.
16044707|NCT02563054|Drug|Cisplatin|Participants will receive cisplastin, 80 mg/m^2 via IV infusion on Day 1 of each 3-week cycle, for a total of 6 cycles or upto disease progression in combination with either capecitabine or 5-FU.
16044708|NCT02563041|Drug|30% TSC|The patients were randomly assigned to have their catheter locked with either unfractionated sodium heparin 5000 U/mL or 30% trisodium citrate.
16044709|NCT02563041|Drug|Heparin|The patients were randomly assigned to have their catheter locked with either unfractionated sodium heparin 5000 U/mL or 30% trisodium citrate.
16044710|NCT02563028|Device|SightSaver Visual Stimulator|Evoked response photic stimulator
16044713|NCT02563002|Drug|mFOLFOX6|Regimen consists of oxaliplatin 85 mg/m^2 IV on Day 1, leucovorin 400 mg/m^2 or levoleucovorin 200 mg/m^2 IV on Day 1, 5-fluorouracil (5-FU) 400 mg/m^2 IV bolus on Day 1 and then 1200 mg/m^2/day IV over 2 days for total dose of 2400 mg/m^2 in each 2-week cycle
16044714|NCT02563002|Drug|FOLFIRI|Regimen consists of irinotecan 180 mg/m^2 IV on Day 1, leucovorin 400 mg/m^2 or levoleucovorin 200 mg/m^2 IV on Day 1, 5-FU 400 mg/m^2 IV bolus on Day 1 and then 1200 mg/m^2/day IV over 2 days for total dose of 2400 mg/m^2 in each 2-week cycle
16044715|NCT02563002|Biological|pembrolizumab|
16044716|NCT02563002|Biological|bevacizumab|
16044717|NCT02563002|Biological|cetuximab|
16044718|NCT02562989|Drug|[18F]MK-6240, ~185 MBq|IV dose of ~185 MBq [18F]MK-6240
16044719|NCT02562989|Drug|[18F]MK-6240, ~160 MBq|IV dose of ~160 MBq [18F]MK-6240
16044720|NCT02562976|Other|gastric atrophy and intestinal metaplasia|use Japanese endoscopic gastric atrophy classification, Operative Link on Gastritis Assessment (OLGA), Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM) to evaluate the severity of gastric atrophy and intestinal metaplasia
16044721|NCT02562963|Biological|natural killer T cell|The eligible patients are infused with two doses of (4±0.5)x10^9 NKT cells in one course of treatment.
16044722|NCT02562950|Drug|GLPG1837 500 mg|Each subject will receive multiple oral daily doses of GLPG1837 (250 mg b.i.d. for 11 days) from Days 2 to 12.
16044723|NCT02562950|Drug|Midazolam|Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 12).
16044724|NCT02562950|Drug|GLPG1837 1000 mg|Each subject will receive multiple oral doses of GLPG1837 (500 mg b.i.d. for 11 days) from Days 2 to 12.
16044725|NCT02562937|Behavioral|text messages related to sedentary behaviour|texts sent twice daily encouraging reduced sedentary behaviour
16044726|NCT02562924|Device|MEDIHONEY®|MEDIHONEY® is a seminatural product with antibacterial and anti-inflammatory properties
16044727|NCT02562924|Drug|Budesonide|Topical steroid
16044728|NCT02562924|Drug|Normal saline sinus rinse|8 oz or 4 oz of normal saline with NeilMed sinus rinse bottle
16044729|NCT02562924|Drug|Prednisone|Post-operatively, 40 mg daily for 7 days
16044730|NCT02562924|Procedure|Endoscopic sinus surgery|Endoscopic sinus surgery to debride polyps and establish adequate sinus drainage
16044731|NCT02562924|Drug|nasal saline spray|saline nasal mist every hour while awake
16044732|NCT02562911|Procedure|Data collection|"Clinical examination
~Complete pelvic ultrasound abdominal ultrasound
~Bone age: X-ray
~biological examination
~Lung function assessed by the Maximum Volume Expired
~Brasfield radiological score (if available)"
16044733|NCT02562898|Drug|Ibrutinib|560, 840, 420, or 280mg, orally once per day - 4 week cycle
16044734|NCT02562898|Drug|Paclitaxel|125mg/m2 IV Day 1, 8, and 15 - 4 week cycle
16044735|NCT02562898|Drug|Gemcitabine|1000mg/m2 IV Day 1, 8, and 15 - 4 week cycle
16044736|NCT02562885|Device|Acoustic pulses|"Acoustic pulses applied during NREM sleep slow waves Up-phase or Down-phase. The acoustic stimulus will be delivered by speakers with a volume of about 50 dB."
16044737|NCT02562872|Drug|DSM265|DSM265 400 mg single oral dose
16044738|NCT02562872|Drug|Placebo|Placebo to match DSM265, single oral dose
16044739|NCT02562872|Biological|Sporozoites|Direct venous inoculation of 3200 cryopreserved Plasmodium falciparum (NF54 strain) sporozoites
16044740|NCT02562872|Biological|Infective mosquito bite|Five single bites by laboratory reared female Anopheles stephensi mosquitoes carrying Plasmodium falciparum
16044741|NCT02562859|Drug|500 mg GLPG1837 as oral suspension|A single dose of 500 mg GLPG1837 administered as oral suspension
16044742|NCT02562859|Drug|500 mg GLPG1837 as oral tablet|A single dose of 500 mg GLPG1837 administered as oral tablet
16044965|NCT02561338|Drug|HMS5552|75mgBID
16044743|NCT02562846|Other|Psychological testing and biological sample collection|For this study, there will be psychological tests, blood and hair sample collections, and part of the patients will undergo an MRI.
16044744|NCT02562833|Device|Self-Management and exercise|Self-Management and exercise It is a 3 months intervention where the participants were enrolled two times per week, 90 minutes each session, first 30 minutes were allocated for the self-management component and the remaining 60 minutes for the exercise component. Additionally,participants received glucosamine and chondroitin sulfate supplement.
16044745|NCT02562833|Device|Educational|This group received an educational book with information about OA features, treatment modalities and exercise education with illustration. Additionally, a monthly educational session each with one hour and a half duration, in total 3, where joint protections strategies, OA self-management and exercise contents were transmitted. Additionally,participants received glucosamine and chondroitin sulfate supplement.
16044746|NCT02562820|Procedure|Intravenous infusion|Intravenous infusion of Ketamine
16044747|NCT02562820|Procedure|Intravenous infusion|Intravenous infusion of Normal Saline
16044748|NCT02562807|Drug|TAS-303 18mg single-dose|
16044749|NCT02562807|Drug|Placebo 18mg single-dose|
16044750|NCT02562807|Drug|TAS-303 9mg single-dose|
16044751|NCT02562807|Drug|Placebo 9mg single-dose|
16044752|NCT02562794|Behavioral|Family Strengthening Intervention-Refugees|This study aims to design a preventive intervention for at-risk refugee children and families. The intervention is focused on strengthening core family resources and promoting resilience and healthy parent-child interactions.
16044753|NCT02562781|Drug|Oxygen|Oxygen in sufficient quantity to maintain SpO2 > 98%
16044754|NCT02562781|Other|Air|Supplemental Oxygen in sufficient quantity to maintain SpO2 > 90%
16044755|NCT02562768|Drug|LY3154207|Administered orally
16044756|NCT02562768|Drug|Placebo|Administered orally
16044757|NCT02562755|Biological|Pexastimogene Devacirepvec (Pexa Vec)|Pexa-Vec is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells.
16044758|NCT02562755|Drug|Sorafenib|"Sorafenib belongs to the pharmacotherapeutic group of antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05.
~Sorafenib is a multi-kinase inhibitor which has demonstrated both anti-proliferative and anti-angiogenic properties in vitro and in vivo.
~Sorafenib is approved for the treatment of advanced HCC and is the Standard Of Care for this disease."
16044759|NCT02562742|Drug|SOF|SOF 400 mg tablets administered orally once daily
16044760|NCT02562742|Drug|REB|REB capsules administered orally in a divided daily weight-based dose according to the package insert for the approved Rebetol® labeling in Japan (< 60 kg = 600 mg , > 60 kg to ≤ 80 kg = 800 mg, and > 80 kg = 1000 mg)
16044761|NCT02562729|Procedure|Nerve-Sparing Radical Hysterectomy|Type C1 NSRH Removal indwelling catheter on day 4 after surgery
16044762|NCT02562716|Drug|Fluorouracil|Given IV
16044763|NCT02562716|Drug|Gemcitabine Hydrochloride|Given IV
16044764|NCT02562716|Drug|Irinotecan Hydrochloride|Given IV
16044765|NCT02562716|Drug|Oxaliplatin|Given IV
16044766|NCT02562716|Drug|Paclitaxel Albumin-Stabilized Nanoparticle Formulation|Given IV
16044767|NCT02562716|Procedure|Pancreatectomy|Undergo pancreatectomy
16044768|NCT02562703|Device|Transcutaneous Vagus Nerve Stimulation|tVNS will be applied by the external simulator (Monarch). The stimulation will be conducted at a frequency of 120 Hz with pulse duration of 250 microseconds. The current intensity will be individually established and should be equivalent to a slight feeling of not painful paresthesia .The stimulus generates a pulse and asymmetric biphasic waveform. Electrodes (25cm2) will be placed over the mastoid process bilaterally. The study protocol will follow the rational of our previous trials with TNS.
16044769|NCT02562690|Other|Thrombin generation assays, TEG and GTT|Thrombin generation assays, Thromboelastography (TEG), and Global Thrombosis Test (GTT)
16044770|NCT02562677|Device|Transcutaneous Trigeminal Nerve Stimulation|
16044771|NCT02562664|Drug|CC|100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle
16044772|NCT02562664|Drug|Placebo tablets|Placebo tablets taken twice daily continuously for three cycles.
16044773|NCT02562664|Drug|Metformin|wMetformin (Cidophage , Amon , Egypt) 500 mg twice daily continuously for three cycles.
16044774|NCT02562651|Drug|Doxycycline|Doxycycline bid for the first 7 days after primary anterior STEMI
16044775|NCT02562651|Other|Standard care for STEMI|Invasive and medical treatment for STEMI according to guidelines
16044776|NCT02562638|Other|Non-fasting|Clear fluids up to 1hour pre-procedure and fasting for solids for up to 4 hours
16044777|NCT02562625|Drug|Pembrolizumab|Powder solution for infusion
16044778|NCT02562625|Radiation|Radiotherapy|24Gy
16044779|NCT02562612|Drug|SM-88|Daily SM-88 in multiple ascending doses over 6 months
16044780|NCT02562599|Drug|raltitrexed-cisplatin|Patients receive raltitrexed-cisplatin neoadjuvant chemotherapy every three weeks for two cycles, then receive raltitrexed -cisplatin concurrent chemoradiotherapy every three weeks for two cycles
16044781|NCT02562599|Radiation|Intensity-modulated radiotherapy (IMRT)|
16044782|NCT02562586|Device|Closed Suction Drainage System|patients undergoing total hip replacement have received a closed suction drainage for 24 hours after the surgical procedure
16044783|NCT02562573|Drug|PBI4050|
16044784|NCT02562560|Behavioral|Neuropsychological tests|
16044785|NCT02562560|Device|Cerebral imaging (MRI, PET-FDG)|
16044786|NCT02562547|Device|Hem-Avert Perianal Stabilizer|The HEM-AVERT® Perianal Stabilizer is an FDA approved Class II device in accordance with FDA regulations 21 CFR 801.109. The HEM-AVERT® Perianal Stabilizer is a non-invasive device used to help provide continuous pressure to the perianal region as a means to help provide support during the labor process.
16044787|NCT02562534|Device|MRI compatible ElectroCardioGraph|MRI with ECG control for people with healthy heart or heart diseases
16044788|NCT02562521|Behavioral|Contingency management|Participants in the intervention group will receive a tailored intervention that utilizes contingency management in which they receive monetary rewards for reducing or quitting smoking.
16044789|NCT02562521|Drug|Nicotine replacement therapy|Participants have the option of using nicotine patch in combination with nicotine gum or lozenge
16044966|NCT02561338|Other|Placebo|QD/BID
16044790|NCT02562521|Drug|Varenicline|Individuals who do not respond initially to Nicotine Replacement Therapy will be offered varenicline as an alternative
16044791|NCT02562521|Behavioral|Additional behavioral support|Based on interest, participants can be referred to a telephone quitline or receive access to mobile text messaging programs or app based smoking cessation support
16044792|NCT02562508|Procedure|3 doses of HPV 16/18 bivalent vaccine|Participants would receive 60μg of HPV 16/18 bivalent vaccine according to the standard 3-dose schedule (0,1,6 months)
16044793|NCT02562508|Procedure|2 doses of HPV 16/18 bivalent vaccine|Participants would receive 60μg of HPV 16/18 bivalent vaccine according to an alternative 2-dose schedule (0,6 months)
16044794|NCT02562495|Device|CT Scan and ultrasonography|Up to three measurements (CT scan and Ultrasonography) of the thickness of quadriceps, will be made concurrently .
16044795|NCT02562482|Biological|VRC-CHKVLP059-00-VP|VRC-CHKVLP059-00-VP is a virus-like particle (VLP) vaccine that consists of CHIKV VLP composed of E1, E2 and capsid proteins of the CHIKV (strain 37997).
16044796|NCT02562482|Other|VRC-PBSPLA043-00-VP|VRC-PBSPLA043-00-VP, a sterile phosphate buffered saline (PBS) is the placebo for the CHIKV VLP vaccine.
16044797|NCT02562469|Other|ACTIVATE|A home-based computerized brain training intervention for youth.
16044798|NCT02562456|Procedure|ART using Fuji IX|Occlusal and occlusoproximal ART restorations in primary molars using the high viscosity GIC Fuji IX will be performed under relative isolation. No local anesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with GIC. After the press-finger technique, the excess of material will be removed and occlusion will be checked. For occlusoproximal restoration, an adapted matrix strip with a wooden wedge will be used to assure appropriate contour.
16044799|NCT02562456|Procedure|Conventional Treatment|Occlusal and occlusoproximal composite resin restorations in primary molars using the Scotchbond Multi-purpose adhesive system and the Filtek Z-350 composite resin wil be performed. Local anesthesia will be used. Absolute isolation will be performed using rubber dam and clamp. Removal of unsupported enamel will be performed using a round bur. Infected carious tissue will be removed with hand instruments. The cavity will be etched using 37% phosphoric acid for 15 seconds followed by rising and drying for the same amount of time. The cavity will be restored with composite resin. Occlusion will be checked. an adapted matrix strip with a wooden wedge will be used to assure appropriate contour.
16044800|NCT02562443|Drug|rigosertib|Patients will receive intravenous rigosertib 1800 mg/24 hr for 3 days every 2 weeks for first 8 cycles, then every 4 weeks thereafter + best supportive care (BSC).
16044801|NCT02562443|Drug|Any approved or standard-of-care therapy|Patients will receive Physician's Choice of Treatment or alternative treatment which may include any approved or standard-of-care therapy, based on frequently used treatment for MDS (no experimental therapy) + best supportive care.
16044802|NCT02562443|Drug|best supportive care (BSC)|Patients will receive best supportive care (BSC): azacitidine (AZA) and/or decitabine (DAC) are permitted.
16044803|NCT02562443|Drug|best supportive care (BSC)|Patients will receive best supportive care (BSC).
16044804|NCT02562430|Drug|Welbutrin XL|12.5% of participants will receive Welbutrin XL in phase 1 of the study.
16044805|NCT02562430|Drug|Placebo|87.5% of subjects will be randomized to placebo in phase 1 of the study.
16044806|NCT02562417|Drug|Normal saline|
16044807|NCT02562417|Drug|IV dexamethasone|
16044808|NCT02562391|Device|Surgical ablation of the left atrium (PVI+Box lesions)|
16044809|NCT02562391|Device|Surgical ablation of the left atrium (PVI+Box lesions) and left atrial appendage cutting|
16044810|NCT02562378|Drug|Trastuzumab and non-pegylated liposomal doxorubicin|Trastuzumab 3.6 mg/kg IV on Day 1 every 3 weeks and non-pegylated liposomal doxorubicin (45 mg/m2, 50 mg/m2 and 60 mg/m2) IV
16044811|NCT02562365|Drug|Etoposide, Cyclophosphamide, Carboplatin|CTX 400mg（250mg/m2）+VP-16 100mg (70mg/m2)d1-d3 iv 4w/6cycles , CBP(AUC=5)+CTX 600mg(400mg/m2)d1-d2 iv 8w/6cycles
16044812|NCT02562352|Other|TAPER program|Patients will be randomized to receive the TAPER program at study start or delayed intervention at 6 months.
16044813|NCT02562339|Behavioral|SMART-3RP|8-week group intervention teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga.
16044814|NCT02562326|Drug|BioChaperone insulin lispro|Injection immediately before the start of the individualised standard meal
16044815|NCT02562326|Drug|Humalog®|Injection immediately before the start of the individualised standard meal
16044816|NCT02562313|Drug|BioChaperone insulin lispro|BioChaperone insulin lispro bolus infusion followed by test meal intake
16044817|NCT02562313|Drug|Humalog®|Humalog® bolus infusion followed by test meal intake
16044818|NCT02562300|Drug|Misoprostol|400 micrograms of sublingual misoprostol were given immediately after delivery of the neonate.
16044819|NCT02562300|Drug|Oxytocin|20 IU oxytocin dissolved in 1 L of Lactated Ringer's or glucose solution) at the rate of 125 ml /h were given immediately after delivery of the neonate.
16044820|NCT02562287|Drug|Clozapine|Flexible dosage, with up-titration according to standard schedules employed for schezophrenia
16044821|NCT02562287|Drug|Risperidone|Risperidone, in a flexible dosage
16044822|NCT02562287|Drug|Olanzapine|Olanzapine, flexible dosage
16044823|NCT02562287|Drug|Quetiapine|Quetiapine, flexible dosage
16044824|NCT02562274|Dietary Supplement|Placebo|Subjects are received placebo treatments once daily for 8 weeks
16044825|NCT02562274|Dietary Supplement|MP 50 mg/day|Subjects are received MP 50 mg/day treatments once daily for 8 weeks
16044826|NCT02562274|Dietary Supplement|MP 1500 mg/day|Subjects are received MP 1500 mg/day treatments once daily for 8 weeks
16044827|NCT02562248|Other|Automated screening for pediatric anxiety|families receiving care at the intervention clinics with concern for disruptive behaviors will be administered the SCARED tool for anxiety in addition to the Vanderbilt tool for ADHD
16044828|NCT02562248|Other|Usual Care|families receiving care at the control clinics with concern for disruptive behaviors will be administered the Vanderbilt tool for ADHD only
16044967|NCT02561325|Drug|Sodium Bicarbonate and Sodium chloride|
16044830|NCT02562222|Procedure|anodal tDCS on M1|"The direct electric current will be applied by surface electrodes with 35cm² and composed of rubbers conductive electricity and surrounded by sponges soaked in saline solution. The electrodes position will be performed according the 10-20 international system of marking and the different montages will be realized by distinct applications sites.
~To stimuli the primary motor cortex the active electrode will be positioned on C3 point and the reference electrode on the contralateral supraorbital region. To visual cortex stimulation, the active electrode will be positioned on the Oz point and the reference on Cz. To duo stimulation, the two electrodes will be considerate actives, stimulating the visual and motor cortex simultaneously. The sham tDCS has already been used in several studies to assess the effect active tDCS and the duration of the current is only 30 seconds."
16044831|NCT02562222|Procedure|cathodal tDCS on M1|"The direct electric current will be applied by surface electrodes with 35cm² and composed of rubbers conductive electricity and surrounded by sponges soaked in saline solution. The electrodes position will be performed according the 10-20 international system of marking and the different montages will be realized by distinct applications sites.
~To stimuli the primary motor cortex the active electrode will be positioned on C3 point and the reference electrode on the contralateral supraorbital region. To visual cortex stimulation, the active electrode will be positioned on the Oz point and the reference on Cz. To duo stimulation, the two electrodes will be considerate actives, stimulating the visual and motor cortex simultaneously. The sham tDCS has already been used in several studies to assess the effect active tDCS and the duration of the current is only 30 seconds."
16044832|NCT02562222|Procedure|anodal tDCS on V1|"The direct electric current will be applied by surface electrodes with 35cm² and composed of rubbers conductive electricity and surrounded by sponges soaked in saline solution. The electrodes position will be performed according the 10-20 international system of marking and the different montages will be realized by distinct applications sites.
~To stimuli the primary motor cortex the active electrode will be positioned on C3 point and the reference electrode on the contralateral supraorbital region. To visual cortex stimulation, the active electrode will be positioned on the Oz point and the reference on Cz. To duo stimulation, the two electrodes will be considerate actives, stimulating the visual and motor cortex simultaneously. The sham tDCS has already been used in several studies to assess the effect active tDCS and the duration of the current is only 30 seconds."
16044833|NCT02562222|Procedure|cathodal tDCS on V1|"The direct electric current will be applied by surface electrodes with 35cm² and composed of rubbers conductive electricity and surrounded by sponges soaked in saline solution. The electrodes position will be performed according the 10-20 international system of marking and the different montages will be realized by distinct applications sites.
~To stimuli the primary motor cortex the active electrode will be positioned on C3 point and the reference electrode on the contralateral supraorbital region. To visual cortex stimulation, the active electrode will be positioned on the Oz point and the reference on Cz. To duo stimulation, the two electrodes will be considerate actives, stimulating the visual and motor cortex simultaneously. The sham tDCS has already been used in several studies to assess the effect active tDCS and the duration of the current is only 30 seconds."
16044834|NCT02562222|Procedure|anodal tDCS on M1 and cathodal on V1|"The direct electric current will be applied by surface electrodes with 35cm² and composed of rubbers conductive electricity and surrounded by sponges soaked in saline solution. The electrodes position will be performed according the 10-20 international system of marking and the different montages will be realized by distinct applications sites.
~To stimuli the primary motor cortex the active electrode will be positioned on C3 point and the reference electrode on the contralateral supraorbital region. To visual cortex stimulation, the active electrode will be positioned on the Oz point and the reference on Cz. To duo stimulation, the two electrodes will be considerate actives, stimulating the visual and motor cortex simultaneously. The sham tDCS has already been used in several studies to assess the effect active tDCS and the duration of the current is only 30 seconds."
16044835|NCT02562222|Procedure|cathodal tDCS on M1 and anodal on V1|"The direct electric current will be applied by surface electrodes with 35cm² and composed of rubbers conductive electricity and surrounded by sponges soaked in saline solution. The electrodes position will be performed according the 10-20 international system of marking and the different montages will be realized by distinct applications sites.
~To stimuli the primary motor cortex the active electrode will be positioned on C3 point and the reference electrode on the contralateral supraorbital region. To visual cortex stimulation, the active electrode will be positioned on the Oz point and the reference on Cz. To duo stimulation, the two electrodes will be considerate actives, stimulating the visual and motor cortex simultaneously. The sham tDCS has already been used in several studies to assess the effect active tDCS and the duration of the current is only 30 seconds."
16044836|NCT02562222|Procedure|sham tDCS|"The direct electric current will be applied by surface electrodes with 35cm² and composed of rubbers conductive electricity and surrounded by sponges soaked in saline solution. The electrodes position will be performed according the 10-20 international system of marking and the different montages will be realized by distinct applications sites.
~To stimuli the primary motor cortex the active electrode will be positioned on C3 point and the reference electrode on the contralateral supraorbital region. To visual cortex stimulation, the active electrode will be positioned on the Oz point and the reference on Cz. To duo stimulation, the two electrodes will be considerate actives, stimulating the visual and motor cortex simultaneously. The sham tDCS has already been used in several studies to assess the effect active tDCS and the duration of the current is only 30 seconds."
16044837|NCT02562209|Dietary Supplement|PACER Diet|Pacer diet to be followed for 8 weeks
16044838|NCT02562209|Other|Standard weight reducing diet|Standard weight reducing diet to be followed for 8 weeks
16044839|NCT02562196|Device|tdcs|"The direct electric current will be applied by surface electrodes with 35cm² and composed of rubbers conductive electricity and surrounded by sponges soaked in saline solution. The electrodes position will be performed according the 10-20 international system of marking and the different montages will be realized by distinct applications sites.
~To stimuli the primary motor cortex the active electrode will be positioned on C3 point and the reference electrode on the contralateral supraorbital region. To visual cortex stimulation, the active electrode will be positioned on the Oz point and the reference on Cz. To duo stimulation, the two electrodes will be considerate actives, stimulating the visual and motor cortex simultaneously. The sham tDCS has already been used in several studies to assess the effect active tDCS and the duration of the current is only 30 seconds."
16044840|NCT02562183|Drug|kallikrein|Using kallikrein
16044841|NCT02562170|Device|TiLoop Bra|
16044844|NCT02562144|Drug|Xylocaine spray|Cutaneous xylocaine spray before intravenous cannulation.
16044845|NCT02562144|Drug|Placebo|Cutaneous placebo before intravenous cannulation.
16044846|NCT02562118|Drug|Lenvatinib + Letrozole|Single agent lenvatinib daily continuously x 2 weeks, followed by letrozole 2.5mg daily + lenvatinib x 12 weeks. Lumpectomy or mastectomy should be considered after completing 14 weeks of pre-operative lenvatinib + letrozole for curative intent in non-metastatic patients and for local control for patients with metastatic disease. If surgery is planned, it should preferably be performed within 2-12 weeks after completing neoadjuvant endocrine therapy, and after toxicities (if any) from the neoadjuvant endocrine therapy have resolved. If the patient is deemed inoperable after 14 weeks of lenvatinib + letrozole, a final biopsy will be obtained, and the patient discontinued from the study and treated as per standard clinical practice by the treating physician.
16044847|NCT02562105|Procedure|Mechanical ventilation|requiring mechanical ventilation at admission to ICU for one day or more during the study period
16044848|NCT02562092|Behavioral|Reducing Risk Behavior|A small survey will be conducted to identify risk factors and assess demographics. Participants will receive psychological support and counseling on reducing risk behavior for one year.
16044849|NCT02562092|Behavioral|Support and Guidance|A small survey will be conducted to identify risk factors and assess demographics. Participants with a positive HIV test will receive standard HIV care, support, and guidance from a psychologist and case manager including an assessment of basic needs (food, clothing, shelter), and counseling on risk taking behaviors for one year.
16044850|NCT02562079|Biological|Blood samples|"biological features of the standard follow-up
~2 more blood tube for the biological collection (serum and PBMC)"
16044851|NCT02562079|Biological|Biopsy|Skin biopsies
16044852|NCT02562066|Drug|amifampridine phosphate|Amifampridine phosphate tablets 10 mg will be provided in round, white-scored tablets, and containing amifampridine phosphate formulated to be the equivalent of 10 mg amifampridine base per tablet.
16044853|NCT02562066|Drug|Placebo|A placebo equivalent will be provided as tablets indistinguishable from the amifampridine phosphate tablets. The placebo will be administered consistent with the dose regimen of amifampridine phosphate.
16044854|NCT02562053|Drug|Fluoxetine|Women will receive oral fluoxetine 20 mg daily.
16044855|NCT02562053|Drug|Combined oral contraceptives|women will receive COC containing drospirenone (drospirenone 3mg+Ethinylestradiol 0.03mg; Yasmin® Schering AG, Egypt) daily for 21 days starting from the 3rd day of menstruation
16044856|NCT02562053|Drug|Placebo 1|Women will receive oral placebo similar to COC daily for 21 days starting from the 3rd day of menstruation
16044857|NCT02562053|Drug|Placebo 2|Women will receive a daily oral placebo similar to fluoxetine
16044858|NCT02562040|Procedure|Early Adenotonsillectomy (eAT)|Standard clinical adenotonsillectomy within 4 weeks post randomization in addition to information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.
16044859|NCT02562040|Behavioral|Watchful Waiting with Supportive Care (WWSC)|Information about healthy sleep habits for children and appropriate clinical referrals for management of co-morbidities.
16044860|NCT02562027|Behavioral|European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30|"30 quality of life questions for the participant to answer
~The first 28 questions have answers that range from 1 (Not at All) to 4 (Very Much)
~The final 2 questions answers range from 1 (Very Poor) to 7 (Excellent)
~Collected at baseline, 3 months post-treatment, 6 months post-treatment, 12 months post-treatment, and 24 months post-treatment"
16044861|NCT02562027|Behavioral|European Organization for Research and Treatment of Cancer Quality of Life Questionnaire LC-13|"13 quality of life questions for the participant to answer
~The answers range from 1 (Not at All) to 4 (Very Much)
~Collected at baseline, 3 months post-treatment, 6 months post-treatment, 12 months post-treatment, and 24 months post-treatment"
16044862|NCT02562027|Behavioral|Modified Medical Research Council|"Participants is given 5 grades to choose from ranging from 0 to 4 and participant will choose grade
~Collected at baseline, 3 months post-treatment, 6 months post-treatment, 12 months post-treatment, and 24 months post-treatment"
16044863|NCT02562027|Behavioral|EQ-5D|"5 headings with 5 statements and the participant will check the box that best describes how he or she feels that day
~The second part shows a scale ranging from 0 (worst health) to 100 (best health) and the participant chooses the best number on the scale
~Collected at baseline, 3 months post-treatment, 6 months post-treatment, 12 months post-treatment, and 24 months post-treatment"
16044864|NCT02562027|Behavioral|Center for Epidemiological Studies Depression Scale|"20 quality of life questions for the participant to answer
~Answers range from Rarely or none of the time to Most or all of the time
~Collected at baseline, 3 months post-treatment, 6 months post-treatment, 12 months post-treatment, and 24 months post-treatment"
16044865|NCT02562027|Behavioral|Medical Outcomes Study Social Support Survey|"19 quality of life questions for the participant to answer
~Answers from from 1 (None of the time) to 5 (All of the time)
~Collected at baseline, 3 months post-treatment, 6 months post-treatment, 12 months post-treatment, and 24 months post-treatment"
16044866|NCT02562014|Other|Glucose|75g glucose
16044867|NCT02562014|Other|Inulin|75g glucose plus 24g inulin
16044868|NCT02562014|Other|Resistant Starch|75g glucose plus 28.2g resistant starch
16044869|NCT02562001|Device|Outpatient active group|active tDCS during 20 minutes before Lokomat training for outpatients
16044870|NCT02562001|Device|Outpatient placebo group|placebo tDCS during 20 minutes before Lokomat training for outpatients
16044871|NCT02562001|Device|Inpatient active group|active tDCS during 20 minutes before Lokomat training for inpatients
16044872|NCT02562001|Device|Inpatient placebo group|placebo tDCS during 20 minutes before Lokomat training for inpatients
16044873|NCT02561988|Drug|Avapritinib|
16044874|NCT02561975|Other|Double pulmonary diffusing|"Measure of double pulmonary diffusing will be done as the single-breath test: the patient will be seated and connected to device by an oral tip. Measure begins by a maximal inhalation of a gas mixture (0.28% of CO, 14% of He, 21% of O2,450 ppm of NO/N2 and 40ppm of NO).After, the patient will maintain an apnea of 4 secondes and will breathe out in oral tip until his residual capacity.
~With the expired air, some parameters will be assessed:
~Alveolar volume (VA)
~Membrane ductance (Dm) and pulmonar capillary volume (values adjusted by Haemoglobin)
~Values of TLCO, TLCO/VA, TLNO, TLNO/VA Vc, Dm, Vc/VA, Dm/VA, TLNO/TLCO et Dm/Vc"
16044875|NCT02561962|Drug|AMG 224|Administered as an IV infusion.
16044876|NCT02561949|Behavioral|YRI|Youth Readiness Intervention (YRI) is an innovative, evidence-based mental health intervention to address co-morbid difficulties with externalizing problems (anger/emotion dysregulation) and internalizing problems (hopelessness/anxiety) among violence-affected youth. YRI methodology draws on evidence-based treatment elements commonly used in both cognitive-behavioral intervention and group interpersonal therapy. YRI has cross-cutting efficacy across a range of mental health conditions common in violence-affected youth. YRI will be delivered in 12 sessions over the course of 3 months.
16044877|NCT02561949|Other|Income generating activity program|Income generating activity programming will be carried out by GOAL in partnership with St. George's foundation through use of their current funding. GOAL focuses on supporting people in need by providing healthcare resources, advocating and advancing child protection practices and policies, and administering livelihood programs to empower them improve their lives in a sustainable manner. The St. George's Foundation's addresses child welfare concerns by actively reaching out to homeless and orphaned children. The program is 4 months in length and consists of skills training, soft skills development (primarily in numeracy and literacy), and a cash transfer of $200.
16044878|NCT02561936|Drug|Rilpivirine Oral Tablet|Rilpivirine formulated as 25 mg oral tablet.
16044879|NCT02561936|Drug|Rilpivirine formulation G007|Rilpivirine G007 formulation as 10*2.5 mg tablets.
16044880|NCT02561936|Drug|Rilpivirine formulation G009-01|Rilpivirine G009-01 formulation as 10*2.5 mg tablets.
16044881|NCT02561936|Drug|Rilpivirine formulation G002|Rilpivirine G002 formulation as 10 g of 2.5 milligram per gram (mg/gm) granules.
16044882|NCT02561936|Dietary Supplement|Standardized Breakfast|It will consist of (or its equivalent) 4 slices of bread, 2 slices of ham and/or cheese, butter, fruit preserve and 1 or 2 cups (up to 480 milliliter [mL]) of decaffeinated coffee or decaffeinated tea with milk and/or sugar, if desired (containing approximately fat: 21 gram (gm), carbohydrates: 67 gm, proteins: 19 gm; calories 533 kilocalorie (kcal) [189 kcal from fat, 268 kcal from carbohydrates, and 76 kcal from proteins]).
16044883|NCT02561923|Drug|Rivaroxaban|A single dose of 20 milligram (mg) of rivaroxaban orally will be administered to participants on Day 1 in part 1 and through day 1 and 3 with a final 20 mg dose administered on the morning of Day 4 in part 2.
16044884|NCT02561923|Drug|Tranexamic acid|1.0 g single dose of tranexamic acid (TXA), intravenously administered (over 10 mins) on Day 4.
16044885|NCT02561923|Drug|Kcentra, a 4-factor PCC|Kcentra, a 4-factor PCC, 50 IU/kg, single dose, intravenously administered (maximum rate of 210 [international units] IU/min) on Day 4.
16044886|NCT02561923|Drug|Saline|Saline [Kcentra saline control or TXA saline control] on Day 4.
16044887|NCT02561910|Device|Laparoscopic hernia repair|Preperitoneal mesh implantation because of inguinal hernia disease using the laparoscopic technique
16044888|NCT02561897|Drug|Edoxaban|
16044889|NCT02561897|Drug|Warfarin|
16044890|NCT02561884|Drug|Olostar Tab.|
16044891|NCT02561884|Drug|Co-administration of Olmetec and Crestor|
16044892|NCT02561871|Biological|Ad26.RSV.FA2|Participants will receive Intramuscular injection of Ad26.RSV.FA2 (5x10^10 virus particles [vp]) on day 1 and 85 in Group 1. Intramuscular injection of Ad26.RSV.FA2 (5x10^10 virus particles [vp]) on day 1 in Group 2.
16044893|NCT02561871|Biological|Ad35.RSV.FA2|Participants will receive Intramuscular injection of Ad35.RSV.FA2 (1x10^11 virus particles [vp]) on day 169 in Group 1. Intramuscular injection of Ad35.RSV.FA2 (1x10^11 virus particles [vp]) on day 85 in Group 2.
16044894|NCT02561871|Drug|Placebo|Participants will receive Intramuscular injection of Placebo control on day 169 in Group 2. Intramuscular injection of Placebo control on day 1, 85 and 169 in Group 3.
16044895|NCT02561858|Other|acid load test|
16044896|NCT02561845|Drug|rosuvastatin|5mg, 10mg, 20mg
16044897|NCT02561832|Drug|Olaparib|tablets taken orally twice daily
16044898|NCT02561832|Drug|Carboplatin|intravenous injections on day one of each cycle
16044899|NCT02561832|Drug|Anthracycline|The choice of anthracycline and cyclophosphamide (AC) regimen in Part B will be up to local Investigator following international guidelines
16044900|NCT02561832|Drug|Cyclophosphamide|The choice of anthracycline and cyclophosphamide (AC) regimen in Part B will be up to local Investigator following international guidelines
16044901|NCT02561806|Drug|Ixekizumab|Administered SC
16044902|NCT02561806|Drug|Ustekinumab|Administered SC
16044903|NCT02561806|Drug|Placebo|Administered SC
16044904|NCT02561793|Drug|DHEA|Women will receive DHEA 12 weeks before starting IVF/ICSI
16044905|NCT02561793|Drug|Placebo|women will receive a placebo 12 weeks before starting IVF/ICSI
16044906|NCT02561780|Behavioral|Curriculum|A mental health educational resource delivered in the classroom by trained educators
16044907|NCT02561780|Behavioral|eLearning Follow-up|An online mental health education module that students access individually
16044908|NCT02561767|Other|bone marrow-derived mesenchymal stem cells|BM-MSCs is harvested from third-party health volunteer donors.
16044909|NCT02561767|Other|Saline|Saline as placebo of MSCs
16044910|NCT02561767|Drug|Induction therapy (ATG or Basiliximab)|ATG, antithymocyte globulin; Basiliximab, anti-CD25 mAb. Recipients receive ATG or Basiliximab as induction therapy in both MSCs group and control group.
16044911|NCT02561767|Drug|Maintenance therapy (Low-dose CNI + MPA + steroids)|Maintenance immunosuppressive therapy consists of low-dose tacrolimus and mycophenolic acid and steroids. Recipients receive the same maintenance therapy in both MSCs group and control group.
16044912|NCT02561754|Dietary Supplement|Enhanced Stop Light Diet (eSLD)|eSDL includes reduced energy portion controlled meals for 6 months, encouraged consumption of lower energy shakes and 35 fruits and vegetables per week.
16044913|NCT02561754|Dietary Supplement|Conventional Diet (CD)|CD is a nutritionally balanced, reduced energy, high volume, lower fat ( fat=20-30% energy) diet.
16044914|NCT02561754|Behavioral|Face-to-face (FTF)|FTF will meet with a health educator in person and will track progress using pen and paper records for both physical activity and diet.
16044915|NCT02561754|Behavioral|Technology (TECH)|TECH groups will receive the intervention using an iPad with the FaceTimeTM application for video meetings with a health educator and will track progress using the Lose it! application for both physical activity and diet.
16044916|NCT02561754|Other|iPad with FaceTime|TECH groups will receive the intervention using an iPad with the FaceTimeTM to the intervention field.
16044917|NCT02561741|Drug|COV155|COV155 tablets
16044918|NCT02561728|Device|Hangar Helmet|Child will be fitted with the Hangar Helmet
16044919|NCT02561728|Device|P-Pod Helmet|Child will be fitted with the P-Pod Helmet
16044920|NCT02561715|Behavioral|Questionnaires|Pre and post deep brain surgery questionnaires
16044921|NCT02561702|Other|Placebo|240 mg lactose powder in a size 3 capsule taken by mouth 3 times daily for 5-7 days
16044922|NCT02561702|Drug|Mexiletine|150 mg Mexiletine taken by mouth in capsule form 3 times daily for 5-7 days
16044923|NCT02561689|Other|Fissure sealing|"Procedure:
~The included teeth of the participating patients will in any case be sealed, but in this study, the operator is not free to choose the material, the material choice is determined by randomisation
~Standardized radiographs (bitewings) will be taken before treatment and after 1, 2, 3 years and possibly after 5 years. Baseline radiograph can be taken up to six months before treatment. If using conventional radiography, double-film packs will be used. A maximum of 8/10 bitewings will be taken during the study period of 3/5 years
~The occlusal surface is sealed by the dentist or dental hygienist.
~Clinical evaluation of the quality of sealants and the need for re-treatments during the follow-up will be performed after 1, 2 and 3 years and possibly after 5 years"
16044924|NCT02561676|Other|Education Program Type 1|The classes will discuss topics related to health and functioning of people with spinal cord injury. During these classes, participants will be given information by the class instructor and will also participate in discussions and other learning activities with the rest of the group. Participants will be assigned activities to complete at home for about 30 minutes per day that relate to the topics discussed in class.
16044925|NCT02561676|Other|Education Program Type 2|The classes will discuss topics related to health and functioning of people with spinal cord injury. During these classes, participants will be given information by the class instructor and will also participate in discussions and other learning activities with the rest of the group. Participants will be assigned activities to complete at home for about 30 minutes per day that relate to the topics discussed in class.
16044926|NCT02561663|Dietary Supplement|NWT-03, an egg-white protein hydrolysate|egg-white protein hydrolysate
16044927|NCT02561663|Other|Placebo|
16044928|NCT02561650|Drug|COV155|COV155 tablets
16044929|NCT02561637|Behavioral|Case management|
16044930|NCT02561637|Behavioral|Control group|
16044931|NCT02561624|Behavioral|Behaviour change communication via text message|
16044932|NCT02561611|Behavioral|Intervention Group|The content of both intervention components will be covered during a weekly scheduled group meeting (or face-to-face meetings, as needed). The step-counting component of the WMPD intervention will be modeled off the success of The First Step Program (FSP).
16044933|NCT02561585|Drug|LEO 124249|
16044934|NCT02561585|Other|Vehicle|
16044935|NCT02561572|Other|Acupuncture|Yintang point acupuncture
16044936|NCT02561559|Radiation|Lung metastasis from soft-tissue sarcoma|Tretament based on Intensity Modulated Radiation Therapy (IMRT) using Volumetric Modulated Arc Therapy (VMAT)
16044937|NCT02561546|Drug|p53 gene therapy|Trans-catheter embolization (TAE) combined with recombinant adenoviral human p53 gene (rAd-p53) will be given one per month
16044938|NCT02561546|Drug|Trans-catheter embolization|Trans-catheter embolization alone
16044939|NCT02561533|Other|BRAF detection on fine needle aspiration biopsy (FNAB)|
16044940|NCT02561520|Biological|PRP eye drops|Eye drops 4x a day, patients will start this eye drop first.
16044941|NCT02561520|Biological|PPP eye drops|Eye drops 4x a day, patients will start this eye drops after PRP.
16044942|NCT02561507|Behavioral|Survey|
16044943|NCT02561494|Drug|Nefopam|
16044944|NCT02561494|Drug|Saline|
16044945|NCT02561481|Drug|Sulforaphane|See under active arm description
16044946|NCT02561481|Drug|Placebo|See under placebo arm description
16044947|NCT02561468|Drug|Nefopam|
16044948|NCT02561468|Drug|Saline|
16044949|NCT02561455|Drug|Gilteritinib|oral tablet
16044950|NCT02561442|Drug|ceftriaxone|
16044951|NCT02561429|Procedure|SPT|SPT of histamine concentration 1, 5 and 10 mg/ml
16044952|NCT02561416|Behavioral|MBSR|Session 1: Recognising the present moment Session 2: Engaging with the breath Session 3: Practice, practice, practice Session 4: Stress and the flow of emotions Session 5: Stress and thoughts: finding another place to stand Session 6: Interpersonal mindfulness / mindful communication. Session 7: Applying mindfulness Session 8: Making mindfulness a part of your life
16044953|NCT02561416|Behavioral|FibroQol|"Session 1: General information. Expectations of the patients. History of the illness. Principal and secondary symptoms in FM. Physiological mechanisms involved in the genesis of pain.
~Session 2: Relaxation training-I. Session 3: Diagnosis. Pharmacological and non-pharmacological treatments. Prognosis. Current model of health care in Catalonia. Units specialized in the treatment of FM.
~Session 4: Relaxation training-II. Session 5: Strategies to increase self-esteem and regulate emotions. Pain experience and recurrent invalidation. Social support (family and friends).
~Session 6: Relaxation training-III Session 7: Benefits of physical exercise in FM. Session 8: Relaxation training-IV."
16044954|NCT02561416|Drug|TAU|In Spain the treatment as usual provided in FMS is mainly pharmacological and adjusted to the symptomatic profile of the patient. Counselling about aerobic exercise adjusted to patients' physical limitations is usually also provided.
16044955|NCT02561403|Behavioral|EVO multitask video game|Participants will play a multitasking game for 4 weeks
16044956|NCT02561403|Behavioral|EVO words video game|Participants will play a word puzzle game for 4 weeks
16044957|NCT02561390|Procedure|Skin prick test|skin prick test to American cockroach, dog, cat, dust mite and mold allergen extracts are performed
16044958|NCT02561390|Other|specific IgE measurement|measure specific IgE of American cockroach, dog, cat, dust mite and mold
16044959|NCT02561377|Behavioral|resistance training|Resistance training consisted of 6 different resistance exercises per session using elastic string, and each exercise progressed to 2-3 at maximum resistance lifted 8-10 times.
16044960|NCT02561377|Behavioral|aerobic training|Aerobic training consisted of aerobic exercise and progressed from 15-20min/session at 60% maximum heart rate to 45-50min/session at 75% maximum heart rate.
16044961|NCT02561351|Other|FeNO measurement|FeNO was performed repeatedly every 3 months in every cases. exacerbations were recorded each visit
16044962|NCT02561338|Drug|HMS5552|75mgQD
16044963|NCT02561338|Drug|HMS5552|100mgQD
16044968|NCT02561312|Other|Rapid manual partial exchange transfusion|The first four participants will receive peripheral red blood cells via rapid manual partial exchange transfusions every month for 6 months. There is a pre-study washout for 3 months then there is a 3 month test period (data collection) before the participant is transferred to ST treatment.
16044969|NCT02561312|Other|Simple Transfusion|The second group of four participants will receive peripheral red blood cells via simple transfusion every month for 6 months. There is a pre-study washout period for 3 months then there is a 3 month test period (data collection) before the participant is transferred to RMPET treatment.
16044970|NCT02561299|Device|Peripheral Orbital Atherectomy System|Orbital Atherectomy
16044971|NCT02561299|Device|014 Drug Coated Balloon|Drug Coated Balloon
16044972|NCT02561286|Behavioral|BRO HIV Risk Reduction Intervention|BRO HIV Risk Reduction Intervention was designed to strengthen outcome expectancies supporting condom use and other sexual risk reduction strategies and skill and self-efficacy to use condoms and reduce sexual risk behaviors. It consisted of three 90-min one-on-one individual sessions implemented during 3 consecutive weeks by specially trained facilitators using standardized intervention manuals. Sessions 1 and 2 included take-home assignments that the participants reviewed at the subsequent session. The delivery of the intervention was tailored to the information that the participants provided during the sessions, including the context in which behaviors occurred and participants' motivation for the behaviors.
16044973|NCT02561286|Behavioral|Health Promotion Intervention|"Health Promotion Intervention was designed to provide a control for Hawthorne effects, reducing the likelihood that the HIV/STI risk-reduction intervention's effects could be attributed to non-specific features, including special attention. It focused on increasing physical activity and fruit-and-vegetable consumption and decreasing fat consumption to reduce the risk of chronic diseases, including heart disease, hypertension, stroke, diabetes, and certain cancers-leading causes of morbidity and mortality among African Americans It also consisted of three 90-min one-on-one individual sessions implemented during 3 consecutive weeks by specially trained facilitators using standardized intervention manuals."
16044974|NCT02561273|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo autologous stem cell transplant
16044975|NCT02561273|Drug|Cyclophosphamide|Given IV
16044976|NCT02561273|Drug|Doxorubicin Hydrochloride|Given IV
16044977|NCT02561273|Drug|Etoposide|Given IV
16044978|NCT02561273|Other|Laboratory Biomarker Analysis|Correlative studies
16044979|NCT02561273|Drug|Lenalidomide|Given PO
16044980|NCT02561273|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo peripheral blood stem cell transplant
16044981|NCT02561273|Drug|Prednisone|Given PO
16044982|NCT02561273|Drug|Vincristine Sulfate|Given IV
16044983|NCT02561247|Device|Prismaflex HF20 CRRT Filter|
16044984|NCT02561247|Device|Prismaflex® System 7.10 and 7.20|
16044985|NCT02561234|Drug|Co-ArgI-PEG|Administered IV
16044986|NCT02561221|Behavioral|Lifestyle Counseling|"Trained health coaches delivered the active intervention - a comprehensive, high-intensity program, as recommended first-line therapy by the 2013 American Heart Association/American College of Cardiology/The Obesity Society Guidelines."
16044987|NCT02561208|Other|mHealth Intervention Group|Women with HPV self-collected tests will receive a mixed intervention which includes counseling through an interactive Apps specifically devised to increase adherence to triage which will be run on a tablet, and SMS text messages (SMS message) to remind them to attend triage. In addition, Heads of CHWs, chiefs of gynecology services and CHWs will receive reminders via e-mails to contact women if after 60 days from the HPV-results HPV+ they have not performed triage.
16044988|NCT02561195|Biological|Clostridium difficile Vaccine|0.5 mL intramuscular injection.
16044989|NCT02561195|Biological|Placebo|0.5 mL intramuscular injection
16044990|NCT02561169|Drug|Oseltamivir|Those randomized to the intervention will receive oseltamivir 75 mg orally twice daily for 5 days within 72 hours of symptom onset. For patients with a known creatinine clearance < 10 ml/min, the recommended dose of 75mg orally daily for 5 days of either intervention or placebo will be administered.
16044991|NCT02561169|Other|Placebo|Those randomized to the control arm will receive 75mg placebo calcium carbonate pills taken twice daily for five days within 72 hours of symptom onset and will be identical in appearance to oseltamivir. For patients with a known creatinine clearance < 10 ml/min, the recommended dose of 75mg orally daily for 5 days of either intervention or placebo will be administered.
16044992|NCT02561156|Drug|TAK-653 Placebo|TAK-653 placebo-matching tablets.
16044993|NCT02561156|Drug|TAK-653|TAK-653 tablets.
16044994|NCT02561143|Dietary Supplement|Improved Atta|Improved Atta is a multi macro- micronutrient bread mix. Patients will be given 100 grams of Improved Atta (to make unleavened bread) everyday for consumption for six months.
16044995|NCT02561143|Dietary Supplement|Wheat flour|Whole wheat flour 100 grams (to make unleavened bread) will be given everyday for consumption for six months to the patients.
16044996|NCT02561143|Behavioral|Physical activity counseling|Depending on the physical status of the patients, low level of physical activity (walking and/or stairs), will be encouraged daily during counseling sessions.
16044997|NCT02561143|Other|Nutritional counseling|Dietary counseling for 30 minutes will be imparted to all patients on every hospital visits by the nutritionist. Consumption of cereals, roots and tubers, vegetables, legumes, nuts, energy dense fruits, milk products (and eggs for non-vegetarians) will be encouraged in their daily diets.
16044998|NCT02561130|Drug|insulin glargine|Dose is titrated to achieve fasting normoglycemia
16044999|NCT02561130|Drug|metformin|Dose is titrated to 1 g bid or maximal tolerated dose
16045000|NCT02561130|Drug|Forxiga|Dose is titrated to 10 mg po daily or maximal tolerated dose
16045001|NCT02561130|Behavioral|Lifestyle therapy|Lifestyle intervention includes individualized dietary and exercise advice and frequent visits for goal reinforcement, behavior modification and problem-solving
16045002|NCT02561117|Drug|Metronidazole|Administration once daily
16045003|NCT02561104|Procedure|Laser-assisted cataract surgery.|
16045004|NCT02561104|Procedure|Traditional manual phacoemulsification|
16045005|NCT02561091|Other|Placebo|
16045006|NCT02561091|Drug|AM-111 0.4 mg/ml|
16045007|NCT02561091|Drug|AM-111 0.8 mg/ml|
16045008|NCT02561078|Drug|Human regular U-500 insulin (CSII)|Administered SC
16045009|NCT02561078|Drug|Human regular U-500 insulin (MDI)|Administered SC
16045010|NCT02561065|Behavioral|Lifestyle intervention|"Each participant will receive 12 personalized lifestyle counseling sessions given face-to-face by a trained practitioner.
~The Fitbit physical activity tracker gives summaries of the participant's physical activity, provides stimulating prompts and rewards, and allows for social media sharing and competition.
~A Sit-stand workstation allows to adjust the height of the participant workstation, including the computer screen, keyboard and mouse and allows them to easily switch between sitting and standing throughout the workday."
16045011|NCT02561039|Drug|Ibandronate|Participants will receive ibandronate, either as a 6-mg IV infusion every 3 to 4 weeks or a 50-mg tablet PO daily, for 4 months.
16045012|NCT02561026|Biological|Frozen plasma|patients randomized to receive frozen plasma transfusions
16045013|NCT02561013|Device|3M™ Coban™ Custom Fit Compression System|"3M Coban™ Fit is a compression system that consists of two components: 1. A Compression Stocking and 2. Coban™ Fit Sleeve.
~The stocking provides compression to the foot and improves wearing comfort in the calf area under the sleeve. The compression sleeve is intended to provide the therapeutic compression to the calf, with the initial fitting to be done by a health-care professional. The compression sleeve is customized according to the anatomy of the patient's leg; both components are designed to be used together."
16045014|NCT02561013|Device|Profore|PROFORE is a multi-layer compression bandaging system developed to apply sustained graduated compression for the management of venous leg ulcers and associated conditions. Multi-layer compression bandaging is the first choice in treatment for venous leg ulcers.
16045015|NCT02561000|Drug|PZ-128|
16045016|NCT02561000|Drug|Placebo|
16045017|NCT02560974|Drug|Capecitabine|Capecitabine will be administered orally at 1000 mg/m^2 BID on Days 1 to 15 of a 3-week cycle, for 8 cycles.
16045018|NCT02560974|Drug|Oxaliplatin|Oxaliplatin will be administered as an IV infusion, 130 mg/m^2 on Day 1 of each 3-week cycle for 8 cycles.
16045019|NCT02560961|Other|Kinesio Taping (Kinesio Tex Gold®; color: black)|Kinesio Taping technique described by Kase for activation of the triceps surae on the dominant leg will be employed, with the volunteer in the prone position, maintaining the dominant leg off the cot with hip extension, knee extension and ankle dorsiflexion to maintain the triceps surae in a stretched position. The tape will be applied in a Y shape beginning with the origin of the muscle (femur condyles) without tension (Anchor I), passing over the belly of the muscle (therapeutic region) with 15 to 20% tension and ending near the posterior surface of the heel (Anchor II) without tension.
16045020|NCT02560961|Other|Placebo Taping|Standard white bandaging tape will be applied by the same researcher who placed the tape in Group A. The application will be performed the same way as a kinesio taping.
16045021|NCT02560948|Biological|Placebo solution|4 x 2 injections over 21 days
16045022|NCT02560948|Biological|gpASIT+TM|4 x 2 injections over 21 days
16045023|NCT02560935|Drug|Hydroxyurea (Moderate Dose)|The study intervention will include moderate dose hydroxyurea therapy at 20 mg/kg/day (range 17.5 - 26 mg/kg/day) for 36 months.
16045024|NCT02560935|Drug|Hydroxyurea (Low Dose)|The study intervention will include random allocation to low dose hydroxyurea therapy at 10 mg/kg/day (range 7 - 15 mg/kg/day) for 36 months.
16045025|NCT02560922|Behavioral|Pain Coping Skills Training (CST)|The pain CST intervention includes 11 individual sessions with a study counselor, delivered via telephone to enhance access and reach. The sessions include the following: general information about why pain coping skills training is important, training in specific pain coping skills (such as progressive muscle relaxation, communication, imagery, and activity pacing), and guided practice with each skill. The CST program will also include information about other behaviors important for OA, such as physical activity and weight management.
16045026|NCT02560909|Biological|FLUAD® influenza vaccine|MF59 adjuvant has been used in seasonal influenza vaccine in Canada and Europe for people ≥65 years. MF59 contains squalene, polysorbate 80, and sorbitan trioleate. It is packaged as small microvesicles of 160nm diameter. The complete mechanism of action of MF59 is not well understood but requires activation of the innate immune system; the adjuvant exerts a local inflammatory response increasing the influx of neutrophils and macrophages to the injection site.
16045027|NCT02560909|Biological|FLUVIRAL®|Standard 2015-2016 nonadjuvanted vaccine
16045028|NCT02560870|Drug|Active Comparator:Aloe Vera mouthwash|mouthwash( Aloe Vera),10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.
16045029|NCT02560870|Drug|Active Comparator:Chlorhexidine mouthwash|mouthwash( Chlorhexidine ),10 ml by patients routinely washed two times in one day for about 30 seconds for two weeks.
16045030|NCT02560857|Other|Quantiferon-Monitor assay|The QFT-Monitor assay is a recently developed non-pathogen specific immune assay based on immune activation of both innate and adaptive immunity.
16045031|NCT02560831|Behavioral|Therapeutic exercise and Pompage|Strengthening exercises for flexors and knee extensors, balance training, knee's pompage twice per week for 12 weeks.
16045032|NCT02560831|Behavioral|Educational lectures|Educational lectures in four meetings for 12 weeks (Control Group)
16045033|NCT02560818|Other|collection of a blood sample and breast and ovarian tissue|a blood sample and a breast and ovarian tissue sample will be collected in healthy women during their surgery (breast or ovarian surgery according to selection group :A, B or C)
16045034|NCT02560818|Other|use of a previous blood collection for patients|
16045035|NCT02560805|Procedure|Microneurography|Skin will be stimulated with a pencil-shaped electrode to find a certain nerve. Once the nerve is found, two tiny sterile wire needles (about the size of acupuncture needles) will be put in the skin. One needle is put just under the skin at a short distance away from the nerve, and the other one into the nerve. The needles are attached to a computer recorder to record the nerve activity. It may take up to one hour to get the needles in the right place. After the tiny needle is in the right place, investigators record nerve activity at rest for about 10 minutes. Then, it will be recorded throughout the rest of the visit (up to 4 hours).
16045036|NCT02560805|Behavioral|Combat virtual reality video clip|Subjects will watch a video clip of combat on a computer screen or wearing video goggles.
16045037|NCT02560805|Procedure|Handgrip Exercise|Subjects will squeeze a hand dynamometer intermittently.
16045038|NCT02560805|Procedure|Cold Pressor Test (CPT)|Subjects' hand will be submerged in cold water (~0-1°C) up to the wrist for 1 minute.
16045039|NCT02560805|Drug|Sodium Nitroprusside (SNP)|Subjects will receive sodium nitroprusside 100 µg, which is bolused through an antecubital intravenous catheter.
16045040|NCT02560805|Drug|Phenylephrine|Subjects will receive phenylephrine 150 µg, which is bolused through an antecubital intravenous catheter 60 seconds after the sodium nitroprusside bolus
16045041|NCT02560805|Drug|Losartan|Subjects will receive Losartan 25 mg once a day orally up to 12 weeks
16045042|NCT02560805|Drug|Atenolol|Subjects will receive Atenolol 25 mg once a day orally up to 12 weeks
16045043|NCT02560792|Behavioral|Positive Affect Condition|"Participants read: Most people exercising at this intensity say that it feels good, and that it makes them feel energized and more positive, and more relaxed afterwards. Thinking about your exercise prescription, please list the reasons or ways in which you, personally, might expect this exercise to lead to positive feelings, and what specifically about this exercise might make you, personally, feel good."
16045044|NCT02560792|Behavioral|Negative Affect Condition|"Participants read: Most people exercising at this intensity say that it doesn't feel very good, and that it makes them feel tired and not so positive, and not very relaxed afterwards. Thinking about your exercise prescription, please list the reasons or ways in which you, personally, might expect this exercise to lead to negative feelings, and what specifically about this exercise might make you, personally, feel bad."
16045045|NCT02560792|Behavioral|Control Condition|Participants receive no information about affective response
16045046|NCT02560779|Drug|Carotuximab (TRC105)|Bi-weekly iv TRC105 (15 mg/kg) will be given with 400mg sorafenib twice daily in the phase 1B portion of the study. Weekly iv TRC105 (10 mg/kg) will be given with 400mg sorafenib twice daily in the phase 2 portion of the study.
16045047|NCT02560779|Drug|Sorafenib|400 mg of sorafenib will be given twice daily.
16045048|NCT02560766|Drug|HORIZANT 300 mg|HORIZANT 300 mg once daily
16045049|NCT02560766|Drug|HORIZANT 600 mg|HORIZANT 600 mg once daily
16045050|NCT02560766|Drug|Placebo|Placebo once daily
16045051|NCT02560753|Drug|T3D-959|The 3mg dosage is supplied as 1mg capsules (three capsules, taken once daily by mouth) The 10mg dosage is supplied as 5mg capsules (two capsules, taken once daily by mouth) The 30mg dosage is supplied as either 5mg or 15mg capsules (six 5mg capsules or two 15mg capsules taken once daily by mouth) The 90mg dosage is supplied as 15mg capsules (six capsules, taken once daily by mouth)
16045052|NCT02560740|Dietary Supplement|PerOx Quench|By 1 week pretreatment of PerOx Quench and following 4 weeks taken to decrease the CIPN incidence.
16045053|NCT02560740|Dietary Supplement|PerOx Quench Placebo|By 1 week pretreatment of Placebo and following 4 weeks taken to record the CIPN incidence.
16045054|NCT02560727|Device|transendoscopic enteral tubing|Investigators designed transendoscopic enteral tubing (TET).The enteral segment of the tube is fixed in the ileocecum with distal segment fixed buttocks. The tube was used for FMT and colonic local administration
16045055|NCT02560727|Device|colonoscope|FMT via colonoscope is the most common approach.
16045056|NCT02560714|Device|SImmetry Sacroiliac Fusion System|"SImmetry
~The SImmetry device is commercially available. The implanted devices consist of a range of threaded, self-tapping, cannulated implants designed to transfix the sacrum and ilium, providing stability for intra-articular fusion.
~The SImmetry Surgical Instruments include standard manual surgical instruments used to access and prepare the sacroiliac joint space for intra-articular fusion."
16045057|NCT02560701|Other|Patient Interview|Investigators will conduct in-depth interviews with approximately 40 commercially insured individuals with bipolar disorder or their family caregivers to explore how they navigate deductibles, copayments, and other complex insurance features. Investigators will also determine the health care services that patients most value and assess how they prioritize difficult health care cost tradeoffs.
16045058|NCT02560688|Drug|DS-1040b|20 mg single 12-hour intravenous infusion
16045059|NCT02560688|Drug|Clopidogrel|Clopidogrel (Plavix) administered orally 300 mg loading dose on Day 1 followed by 75 mg daily on Days 2-5
16045060|NCT02560662|Behavioral|Physical activity|"Preoperative intervention - takes place from randomization until surgery (4 weeks +/-2 w):
~• 30 minutes of exercise daily added to the existing daily exercise routine. The level of exercise should produce shortness of breath but the patient should be able to talk without much effort.
~Postoperative intervention - takes place from discharge from the hospital until 4 weeks postoperatively:
~• 30 minutes of exercise daily added to the existing daily exercise routine. The level of exercise should produce shortness of breath but the patient should be able to talk without much effort.
~Participants randomized to intervention will receive a visit to a physiotherapist for personally adjusted information regarding the intervention, later followed up with a telephone call."
16045061|NCT02560649|Drug|Peginterferon alfa-2a plus Entecavir|Peginterferon alfa-2a 180μg /wk plus Entecavir 0.5mg qd for 48 weeks(Arm A and B)
16045062|NCT02560649|Drug|Peginterferon alfa-2a plus Lamivudine|Peginterferon alfa-2a 180μg /wk plus Lamivudine 0.1g qd for 48 weeks(Arm A and B)
16045063|NCT02560649|Drug|Peginterferon alfa-2a plus Adefovir|Peginterferon alfa-2a 180μg /wk plus Adefovir 10mg qd for 48 weeks(Arm A and B)
16045064|NCT02560649|Drug|Peginterferon alfa-2a plus Tenofovir|Peginterferon alfa-2a 180μg /wk plus Tenofovir 300mg qd for 48 weeks(Arm A and B)
16045065|NCT02560649|Drug|Entecavir|Entecavir 0.5mg qd for 24 weeks(Arm C)
16045066|NCT02560649|Drug|Lamivudine|Lamivudine 0.1g qd for 24 weeks(Arm C)
16045067|NCT02560649|Drug|Adefovir|Adefovir 10mg qd for 24 weeks(ArmC)
16045068|NCT02560649|Drug|Tenofovir disoproxil|Tenofovir 300mg qd for 24 weeks(Arm C)
16045069|NCT02560636|Drug|Pembrolizumab|Pembrolizumab - Trial Treatment
16045070|NCT02560636|Radiation|Radiotherapy|Radiotherapy
16045071|NCT02560623|Device|Sponge capsule|Subjects will swallow sponge capsule and esophageal cells will be collected on deployed sponge.
16045072|NCT02560610|Drug|OC000459|
16045073|NCT02560610|Drug|Placebo|
16045074|NCT02560597|Procedure|repetitive transcranial magnetic stimulation|"Stimulation over the epileptogenic focus using variable stimulation protocols as described in literature. This protocol may vary case by case, depending on patient characteristics and achieved effect from previous stimulation.
~In absence of effect, rTMS is given on 5 consecutive days at most."
16045075|NCT02560584|Drug|Hexaminolevulinate hydrochloride|Instillation in bladder
16045076|NCT02560584|Device|KARL STORZ D-Light C PDD Flexible Videoscope System|Cystoscopy procedure
16045077|NCT02560571|Device|ultrasound|
16045078|NCT02560571|Other|blood test|
16045248|NCT02559453|Procedure|Debridement|Removing dead tissue from infected wounds.
16045079|NCT02560558|Drug|Belatacept|Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg at 4-weekly or 8-weekly intervals.
16045080|NCT02560545|Drug|Cannabis oil|Cannabis oil 20% THC
16045081|NCT02560532|Drug|Clazosentan|Concentrated solution for intravenous injection
16045082|NCT02560519|Drug|Albumin solution|"Albumin solution will used for priming of the CPB(cardio-pulmonary bypass) tubing. : A mixture of 20% (200 mg/mL) albumin (Albuman® 200 g/L, Sanquin, the Netherlands) with Ringer's acetate solution in the final albumin concentration of 4%.
~During surgery and the first 24 hours of ICU treatment, albumin 4% solution will be used up to 3200 mL for volume replacement therapy. Ringer's acetate solution is used thereafter, i.e. if more than 3200 mL are needed for volume replacement therapy.The volume replacement therapy is not determined but will be based on the clinical decision."
16045083|NCT02560519|Drug|Ringers acetate solution|"The Ringers acetate solution will be used for priming of the CPB tubing. The CPB priming volume comprises only of Ringer´s solution.
~During surgery and the first 24 hours of ICU treatment,Ringer´s acetate solution will be used up to 3200 mL for volume replacement therapy. Ringer's acetate solution is used thereafter, i.e. if more than 3200 mL are needed for volume replacement therapy during the second study phase. The volume replacement therapy is not determined but will be based on the clinical decision."
16045084|NCT02560506|Device|Elastic assisted treadmill walking|Rubber band pulley system that will assist therapists in advancing limbs while gait training. The device is positioned in front of a treadmill and the stretch of the elastic bands when a legs moves backwards on a treadmill is resists the movement and facilitates limb swing when walking.
16045085|NCT02560493|Behavioral|Exergaming Condition|Participants are encouraged to meet the MVPA goal of 60 minutes/day, which will be gradually achieved beginning with 10 minutes/day in Week 1 and reaching 60 minutes/day in Week 6. Three hours each week will be devoted to exergame play, following prescribed exergame routines.
16045086|NCT02560480|Device|magnetic resonance imaging|to diagonose groin injury exactly in magnetic resonance imaging
16045087|NCT02560467|Drug|Echo and myocardial contrast echocardiography perfusion imaging|"Myocardial blood flow will be assessed by myocardial contrast echo. Perfusion at rest and stress will be quantified and compared to patient sx, degree of dysfunction on echo strain imaging, and degree of fibrosis on magnetic resonance imaging (when available) that was ordered as part of routine clinical care.
~Myocardial contrast echocardiography will be performed by intravenous administration of ultrasound contrast agent (Definity or Lumason) using FDA-approved dose limits. Vasodilator stress during MCE imaging will be performed using regadenoson at FDA-approved doses."
16045088|NCT02560454|Behavioral|Cogmed|"Cogmed training working memory (unifactorial). Before beginning the program an appointment of one hour will be organized to present the program.
~Participants will train at home during 25 sessions (about 30-45 minutes each) over a maximum of 5-6 weeks.
~A coach will call the participant one a week to verify program adherence. The coach will verify participant results on internet before calling.
~Cogmed working memory training CogMed RM® (RoboMemo,Cognitive Medical Systems AB, Stockholm) version for children will be used in this program. Twelve exercises target verbal and visio-spatial working memory. Difficulty is adjusted depending on participant performance's"
16045089|NCT02560454|Behavioral|Presco|"Presco drive of several cognitive functions (multifactorial). Before beginning the program an appointment of one hour will be organized to present the program.
~Participants will train at home during 25 sessions (about 30-45 minutes each) over a maximum of 5-6 weeks.
~A coach will call the participant one a week to verify program adherence. The coach will verify participant results on internet before calling.
~The program PRESCO® (Program in Cognitive Stimulation and rehabilitation ) comprises 40 exercises targeting: verbal and visio spatial working memory, attention capacities, reasoning, executive functioning , language and mental imagery. Only exercises targeting verbal, visual spatial working memory, and attentional capacities altered in ADHD are used in this present study. Difficulty is adjusted depending on the participant performances."
16045090|NCT02560441|Other|chemotherapy followed by radiotherapy|
16045091|NCT02560441|Other|radiotherapy followed by chemotherapy|
16045092|NCT02560441|Drug|IPGDP regimen chemotherapy|
16045093|NCT02560428|Behavioral|ESCALATES|The investigators collect and analyze qualitative data to identify the most effective combinations of intervention strategies for various practice types, contexts, and organizational characteristics, and to understand why and how those combinations are effective. The investigators also gather de-identified quantitative data that the R18s collected.
16045094|NCT02560415|Device|Experimental|Gaming Open Library for Intervention in Autism at Home plus Treatment as usual
16045095|NCT02560415|Behavioral|Comparator|Treatment as usual
16045096|NCT02560389|Drug|Placebo|Sugar pill packaged to resemble levodopa
16045097|NCT02560389|Drug|Levodopa|EIther 100mg or 200 mg, depending on arm assignment, administered once by mouth.
16045098|NCT02560376|Drug|68Ga-NOTA-exendin-4|68Ga-NOTA-exendin-4 were injected into the patients before the PET/CT scans
16045099|NCT02560363|Drug|AZD9977 immediate release (IR) oral suspension|120 mg (4.8 mL x 25 mg/mL) oral suspension, single dose
16045100|NCT02560363|Drug|AZD9977 extended release (ER) capsules [fast]|120 mg (2 x 60mg capsules) single dose
16045101|NCT02560363|Drug|AZD9977 extended release (ER) capsules [intermediate]|120 mg (2 x 60mg capsules) single dose
16045102|NCT02560363|Drug|AZD9977 extended release (ER) capsules [slow]|120 mg (2 x 60mg capsules) single dose
16045103|NCT02560350|Other|no intervention|no intervention
16045104|NCT02560337|Drug|Cabazitaxel|
16045105|NCT02560324|Drug|Ramelteon|
16045106|NCT02560324|Drug|Placebo|
16045107|NCT02560311|Other|observation|
16045108|NCT02560298|Drug|Capecitabine|
16045109|NCT02560298|Drug|Carboplatin|Given IV
16045110|NCT02560298|Drug|Cisplatin|Given IV
16045111|NCT02560298|Drug|Fluorouracil|Given IV
16045112|NCT02560298|Other|Laboratory Biomarker Analysis|Correlative studies
16045113|NCT02560298|Drug|Paclitaxel|Given IV
16045114|NCT02560298|Other|Quality-of-Life Assessment|Ancillary studies
16045115|NCT02560272|Biological|Minhai-HIB|0.5ml, intramuscular
16045116|NCT02560272|Biological|Act-HIB®|0.5ml, intramuscular
16045117|NCT02560259|Other|Physiotherapy|Physiotherapy
16045118|NCT02560259|Other|Conservative treatment|Conservative treatment
16045119|NCT02560233|Other|Contingent RT-fMRI-NF|Subjects are provided with contingent RT-fMRI-NF of brain activity in the target region of interest.
16045120|NCT02560233|Other|Sham RT-fMRI-NF|Subjects are provided with sham RT-fMRI-NF of brain activity of previously recorded subject.
16045121|NCT02560220|Biological|Mitomycin C-induced peripheral blood mononuclear cells (MICs)|MICs are given intravenously 2 or 7 days before kidney transplantation from a living donor
16045122|NCT02560207|Drug|Cefotaxime|To assess the influence of administration route on target attainment cefotaxime is administered via two IV routes.
16045123|NCT02560194|Procedure|Flexible Sigmoidoscopy|Examination of the rectal and distal colon by means of a flexible endoscope
16045124|NCT02560194|Other|Fecal occult blood test|Test for hemoglobin in faeces
16045125|NCT02560181|Radiation|HDR brachytherapy|Whole gland salvage
16045126|NCT02560168|Device|MyoVista device|MyoVista device is a standard EKG device with additional capabilities in detecting cellular level myocardial electrophysiological signals. The device involves placing leads on the chest, similar to a traditional EKG device
16045127|NCT02560168|Device|Computed tomographic coronary angiography|Traditional method of detecting coronary artery disease. CTA will be performed using 64-detector row or higher scanners with electrocardiographic gating in accordance with the Society of Cardiovascular Computed Tomography (SCCT) guidelines. Approximately 80 to 100 ml of intravenous contrast, followed by 50 to 80 ml of saline, will be administered at a rate of 5 ml/s via a power injector through an antecubital vein (on forearm near the elbow).
16045128|NCT02560168|Device|Transthoracic Echocardiography|
16045129|NCT02560155|Drug|Mupirocin 2% nasal ointement|Mupirocin nasal ointement 2x/d for 5 days preoperatively
16045130|NCT02560155|Drug|Chlorhexidine sol 4%|Shower with Chlorhexidine sol 4% once a day for 5 days preoperatively
16045131|NCT02560129|Other|Questionnaires, Physical and Cognitive Function|ICU survivors will be administered a battery of questionnaires. Measurements of physical and cognitive function will also be performed.
16045132|NCT02560103|Other|Transmeridian travel across multiple time zones|
16045133|NCT02560090|Behavioral|Surveys|The following information will be collected: demographics, literacy screener, depression screener, medication adherence, self-efficacy, tobacco use, patient activation, health questionnaire, eating patterns, diabetes self-management assessment, stages of change questionnaire, vitals, and self-care behaviors.
16045134|NCT02560090|Behavioral|Telephonic Nurse Intervention|A nurse will contact patients by phone at least weekly for month 1 and at least every other week for months 2 and 3 and will collect the following information: medication adherence, discharge plan adherence, problem solving, diet and physical activity issues and to assess self-management, dietary, and physical activity improvements. In addition the nurse will link participants with resources.
16045135|NCT02560090|Behavioral|In-person Community Health Worker|An in-person Community Health Worker will contact patients in-person at least weekly for month 1 and at least every other week for months 2 and 3 and will collect the following information: medication adherence, discharge plan adherence, problem solving, diet and physical activity issues and to assess self-management, dietary, and physical activity improvements. In addition the nurse will link participants with resources.
16045136|NCT02560077|Other|placebo|Subject receive the Placebo product (placebo group had same color and smell of treatment groups)
16045137|NCT02560077|Other|cashew apple juice|Subject received the cashew apple juice at dose of 120 mg/day after meal
16045138|NCT02560077|Other|cashew apple juice|Subject received the cashew apple juice at dose of 240 mg/day after meal
16045139|NCT02560064|Procedure|Laparotomy|Small bowel length will measure in laparotomy, regardless of indication.
16045140|NCT02560051|Drug|Doxorubicin|In weeks 1, 3, and 5 of each 8-week cycle, participants will receive doxorubicin (20 mg/m2 as a 24-hour intravenous infusion on day 1 of each applicable week)
16045141|NCT02560051|Drug|Ketoconazole|In weeks 1, 3, and 5 of each 8-week cycle, participants will receive ketoconazole (400 mg orally 3 times daily for 7 days)
16045142|NCT02560051|Drug|Docetaxel|In weeks 2, 4, and 6 of each 8-week cycle, participants will receive docetaxel (35 mg/m2 intravenously on day 1 of each applicable week)
16045143|NCT02560051|Drug|Estramustine|In weeks 2, 4, and 6 of each 8-week cycle, participants will receive estramustine (280 mg orally 3 times daily for 7 days)
16045144|NCT02560051|Drug|Degarelix|The starting dose (240 mg given as two injections of 120 mg each) is followed by maintenance doses of 80 mg administered as a single injection every 28 days
16045145|NCT02560038|Drug|Gemcitabine|1000 mg/m2 will be administered as an IV infusion over 10 mg/minute on Days 1 and 8 of each cycle (each cycle is 21 days).
16045146|NCT02560038|Drug|Paclitaxel|175 mg/m2 will be administered as an IVPB over 3 hours on Day 2 of each cycle (each cycle is 21 days).
16045147|NCT02560038|Drug|Cisplatin|70 mg/m2 will be administered as an IVPB over 2 hours on Day 2 of each cycle (each cycle is 21 days).
16045148|NCT02560025|Drug|Alisertib|
16045149|NCT02560025|Drug|Cytarabine|
16045150|NCT02560025|Drug|Idarubicin|
16045151|NCT02560025|Drug|Daunorubicin|Can be used in place of idarubicin
16045152|NCT02560012|Drug|Sunitinib|One 50-mg capsule taken orally once daily, on a schedule of 4 weeks on treatment followed by 2 weeks off
16045153|NCT02560012|Drug|Temsirolimus|25 mg by an IV infusion over 30-60 minutes, once a week
16045154|NCT02560012|Drug|Sorafenib|400 mg (2 tablets) orally twice daily without food
16045155|NCT02560012|Drug|Pazopanib|800 mg orally once a day without food, at least 1 hour before or 2 hours after a meal
16045156|NCT02560012|Drug|Everolimus|10 mg orally once daily with or without food
16045157|NCT02560012|Drug|Axitinib|5 mg orally twice daily
16045158|NCT02559999|Other|Painful tonic stimuli|
16045159|NCT02559999|Other|non-painful stimuli|
16045160|NCT02559986|Other|telephone interview|telephone interview about their care received during the first year of life and associated events
16045161|NCT02559973|Drug|RBP-6000|RBP-6000 uses buprenorphine in the ATRIGEL Delivery System. The single-syringe is prefilled with RBP-6000 containing 300 mg buprenorphine.
16045162|NCT02559973|Drug|SUBOXONE Sublingual Film|Subjects will be dose-stabilized on SUBOXONE sublingual film prior to administration of RBP-6000. SUBOXONE sublingual film will be administered beginning after the subject is experiencing signs and symptoms of withdrawal on Day -8 and continue until Day -1.
16045163|NCT02559960|Drug|Breviscapine Powder-Injection|Patients will be given Breviscapine Powder-Injection according to their disease condition in the real world. The investigator only can record the information on the usage of the drug and the relevant medications without any interventions.
16045164|NCT02559934|Drug|SR-T100 Gel|0.3-0.5 g topical SR-T100 gel (containing 2.3% solamargine in Solanum undatum plant extract)
16045165|NCT02559921|Biological|rhRIG（20 IU/kg）|
16045166|NCT02559921|Biological|rhRIG（40 IU/kg）|
16045167|NCT02559921|Biological|HRIG（20 IU/kg）|
16045168|NCT02559921|Biological|rhRIG（20 IU/kg） and vaccine|
16045169|NCT02559921|Biological|rhRIG（40 IU/kg） and vaccine|
16045170|NCT02559921|Biological|HRIG（20 IU/kg） and vaccine|
16045171|NCT02559921|Biological|placebo and vaccine|
16045172|NCT02559908|Device|Hyaluronic Acid Injectable Gel|Hyaluronic Acid Injectable Gel (VYC-25L) injection into the chin and/or jaw areas (up to 4.0 mLs).
16045173|NCT02559895|Drug|ALD403|
16045174|NCT02559895|Drug|Placebo|
16045175|NCT02559869|Drug|[18F] GE-180|PET Tracer Ligand
16045176|NCT02559856|Drug|Apixaban|
16045177|NCT02559856|Drug|Rivaroxaban|
16045178|NCT02559843|Dietary Supplement|pomegranate juice|
16045179|NCT02559843|Behavioral|lifestyle modification|
16045180|NCT02559830|Genetic|transduced CD34+ hematopoietic stem cell|Autologous hematopoietic stem cells (HSCs) collected from the mobilized peripheral blood and transduced ex vivo with a Lentiviral vector encoding the human ARSA(for MLD)/ABCD1(for ALD) cDNA（complementary DNA）. Dose: ≥ 2x10^6 transduced CD34+ cells/Kg (maximum 20x10^6) at bedside for infusion.
16045181|NCT02559817|Drug|Linaclotide Dose A|
16045182|NCT02559817|Drug|Linaclotide Dose B|
16045183|NCT02559817|Drug|Linaclotide Dose C|
16045184|NCT02559817|Drug|Linaclotide Approved Adult Dose|
16045185|NCT02559817|Drug|Matching Placebo|
16045186|NCT02559804|Other|survival and late effects|survival and late effects
16045187|NCT02559791|Biological|Reslizumab|Reslizumab 3ml/kg once monthly for 4 months
16045188|NCT02559791|Drug|Placebo|Matching placebo once monthly for 2 months
16045189|NCT02559778|Drug|Ceritinib|One of the following drugs will be chosen for each subject based on molecular guided results: Ceritinib, dasatinib, sorafenib or vorinostat. This will be followed by consolidation, immunotherapy +/- DFMO, and then all subjects will receive DFMO for 2 years as maintenance.
16045190|NCT02559778|Drug|dasatinib|One of the following drugs will be chosen for each subject based on molecular guided results: Ceritinib, dasatinib, sorafenib or vorinostat. This will be followed by consolidation, immunotherapy +/- DFMO, and then all subjects will receive DFMO for 2 years as maintenance.
16045191|NCT02559778|Drug|sorafenib|One of the following drugs will be chosen for each subject based on molecular guided results: Ceritinib, dasatinib, sorafenib or vorinostat. This will be followed by consolidation, immunotherapy +/- DFMO, and then all subjects will receive DFMO for 2 years as maintenance.
16045192|NCT02559778|Drug|vorinostat|One of the following drugs will be chosen for each subject based on molecular guided results: Ceritinib, dasatinib, sorafenib or vorinostat. This will be followed by consolidation, immunotherapy +/- DFMO, and then all subjects will receive DFMO for 2 years as maintenance.
16045193|NCT02559778|Drug|DFMO|DFMO will be given to Arm B during immunotherapy and then for 2 years as maintenance to all subjects completing immunotherapy.
16045194|NCT02559752|Other|NIH Toolbox Cognitive Battery|"For ages 4 to 7 years, the NIH Toolbox Early Childhood Battery will be administered. This test includes the Picture Vocabulary, Flanker Inhibitory Control and Attention, Dimensional Change Card Sort, and Picture Sequence Memory measures to evaluate language, executive function, attention, and episodic memory, respectively.
~For patients age 8 years or older, the administered battery will consist of the aforementioned tests in addition to Oral Reading Recognition, Pattern Comparison Processing Speed, and List Sort Working Memory tests. Results will include scores for each individual measure. In addition, each cognition battery provides composite scores, which allow for general interpretation/evaluation of overall cognitive functioning."
16045195|NCT02559726|Procedure|Echocardiography (TEE)|
16045196|NCT02559726|Device|Magnetic resonance imaging (MRI) with gadolinium enhancement|
16045197|NCT02559726|Device|Magnetic resonance imaging (MRI) without gadolinium enhancement|
16045198|NCT02559726|Procedure|3D electrocardiographic mapping (ECM)|
16045199|NCT02559713|Drug|Vedolizumab|Vedolizumab IV infusion
16045200|NCT02559700|Behavioral|Brain training programme|An online package of brain training programmes
16045201|NCT02559687|Biological|pembrolizumab|IV Q3W
16045202|NCT02559674|Biological|Gemcitabine|Intravenous Infusion; Patients will receive two 4-week treatment cycles consisting of gemcitabine given on Day 1, 8, 15, 29, 36, and 43. Eligible patients may receive up to 10 additional treatment cycles.
16045203|NCT02559674|Biological|Nab-paclitaxel|Intravenous Infusion; Patients will receive two 4-week treatment cycles consisting of nab-paclitaxel given on Day 1, 8, 15, 29, 36, and 43. Eligible patients may receive up to 10 additional treatment cycles.
16045204|NCT02559674|Biological|ALT-803|Subcutaneous Injection; Patients will receive two 4-week cycles consisting of ALT-803 given on Day 2, 9, 16, 30, 37, and 44. Eligible patients may receive up to 10 additional treatment cycles.
16045205|NCT02559661|Other|Training on a virtual simulator in eye surgery|
16045206|NCT02559648|Drug|Denosumab|"Patients will be randomly assigned, in a 1:1 fashion, to the two therapeutic arms (Group A, Group B, respectively), upon enrollment in the study.
~The effect of denosumab on lumbar spine BMD (bone mineral density) in patients with Thalassemia Major and Osteoporosis as compared with control at 12 months will be evaluated."
16045207|NCT02559648|Drug|Placebo|"Patients will be randomly assigned, in a 1:1 fashion, to the two therapeutic arms (Group A, Group B, respectively), upon enrollment in the study.
~The effect of denosumab on lumbar spine BMD (bone mineral density) in patients with Thalassemia Major and Osteoporosis as compared with control at 12 months will be evaluated."
16045208|NCT02559635|Procedure|Bowel stimulation|Stimulation will be performed daily on an outpatient basis for the two weeks (ten business days) prior to ileostomy closure by a trained research assistant. The efferent limb of the ileostomy loop will be canalized with an 18 Fr Foley catheter and infused with a solution comprising of 500mL of normal saline mixed with 30g of a thickening-agent (Nestle Resource). It will be prepared in five 100mL syringes and administered slowly over 20 minutes.
16045209|NCT02559635|Drug|Nestle Resource|Stimulation will be performed daily on an outpatient basis for the two weeks (ten business days) prior to ileostomy closure by a trained research assistant. The efferent limb of the ileostomy loop will be canalized with an 18 Fr Foley catheter and infused with a solution comprising of 500mL of normal saline mixed with 30g of a thickening-agent (Nestle Resource). It will be prepared in five 100mL syringes and administered slowly over 20 minutes.
16045210|NCT02559622|Drug|Secukinumab|300 mg secukinumab
16045211|NCT02559622|Other|Placebo|Placebo followed by 300 mg secukinumab
16045212|NCT02559622|Other|Placebo|Placebo followed by 150 mg secukinumab
16045213|NCT02559622|Drug|Secukinumab|150 mg secukinumab
16045214|NCT02559609|Behavioral|contingency management for alcohol abstinence|Participants will earn chances to win prizes for each negative breath alcohol recording provided.
16045215|NCT02559609|Behavioral|contingency management for activity completion|Participants will earn chances to win prizes for completing specific job-related activities.
16045216|NCT02559609|Behavioral|activity contracting|Participants will complete job-related activity contracts each week with the goal of obtaining employment.
16045217|NCT02559583|Other|Chronic Lymphocytic Leukemia (CLL)|This is observational study. Participants with Chronic Lymphocytic Leukemia (CLL) will be observed for 1 year.
16045218|NCT02559583|Other|Multiple Myeloma (MM)|This is observational study. Participants with Multiple Myeloma (MM) will be observed for 1 year.
16045219|NCT02559583|Other|Non-Hodgkin's lymphoma (NHL)|This is observational study. Participants with non-Hodgkin's lymphoma (NHL) will be observed for 1 year.
16045220|NCT02559570|Drug|Placebo|Participants received matching placebo LIN liquid solution or solid capsules, orally, 30 minutes before evening meal, once daily for 4 weeks.
16045221|NCT02559570|Drug|LIN Dose A|Participants received LIN 9 or 18 ug liquid solution or solid capsules, orally, 30 minutes before evening meal, once daily for 4 weeks.
16045222|NCT02559570|Drug|LIN Dose B|Participants received LIN 18 or 36 ug liquid solution or solid capsules, orally, 30 minutes before evening meal, once daily for 4 weeks.
16045223|NCT02559570|Drug|LIN Dose C|Participants received LIN 36 or 72 ug liquid solution or solid capsules, orally, 30 minutes before evening meal, once daily for 4 weeks.
16045224|NCT02559570|Drug|LIN 145 µg|Participants received LIN 145 µg, liquid solution or solid capsules, 30 minutes before evening meal, once daily for 4 weeks.
16045225|NCT02559557|Other|Educational Intervention|Participate in focus groups
16045226|NCT02559557|Other|Educational Intervention|Undergo Spanish-adapted skills training and homework assignments
16045227|NCT02559557|Other|Quality-of-Life Assessment|Answer questionnaires
16045228|NCT02559557|Other|Questionnaire Administration|Answer questionnaires
16045229|NCT02559531|Device|Mobile triage system|A mobile triage system used by EMS providers will be evaluated using standardized clinical vignettes
16045230|NCT02559518|Device|tDCS|Current will be applied by a DC stimulator (NeuroConn Plus, Germany).The active electrode (anode: 5x5 cm²) will be placed over the left cerebellar hemisphere (3 cm lateral to the inion) and the reference (5x7 cm²), over the right arm with current intensity of 2mA, fade in and fade out of 10 seconds, during 20 minutes.
16045231|NCT02559518|Device|tDCS|Current will be applied by a DC stimulator (NeuroConn Plus, Germany). The active electrode (cathode: 5x5 cm²) will be placed over the left cerebellar hemisphere (3 cm lateral to the inion) and the reference (5x7 cm²), over the right arm with current intensity of 2mA, fade in and fade out of 10 seconds, during 20 minutes.
16045232|NCT02559518|Device|tDCS|Sham ctDCS will be applied using the same electrodes placement and parameter settings of cathodal ctDCS. However, stimulation will last only 30 seconds but volunteers will be with electrodes montage for 20 minutes.
16045233|NCT02559518|Device|rTMS|High frequency c-rTMS will be applied through a figure-eight coil connected to a magnetic stimulator (Rapid², Magstim, UK) placed over the left cerebellar hemisphere (3 cm lateral to the inion), tangentially to the scalp and pointing upwards. Protocol: 10Hz, 110% RMT, 33 trains, 50 stimuli per train, intertrain interval of 25 seconds, 1650 stimuli.
16045234|NCT02559518|Device|rTMS|Low frequency c-rTMS will be applied through a figure-eight coil connected to a magnetic stimulator (Rapid², Magstim, UK) placed over the left cerebellar hemisphere (3 cm lateral to the inion), tangentially to the scalp and pointing upwards. Protocol: 1Hz, 110% RMT, 1000 stimuli (1 train).
16045235|NCT02559518|Device|rTMS|Sham c-rTMS will be performed with low frequency protocol using two coils. The first one - connected to the stimulator (Rapid², Magstim, UK) - will be positioned on a coil support close to the volunteer but not visible. Therefore, characteristic stimulation noises will be audible. The second - disconnected to the stimulator - will be placed over left cerebellar hemisphere.
16045236|NCT02559518|Device|pp-TMS assessment|SICI and ICF will be evaluated through pp-TMS. Subthreshold conditioning stimuli (80% of RMT) and suprathreshold test stimuli (120% of RMT) will be delivered at 2 milliseconds ISI, in order to determine SICI. ICF will be evaluated by MEP average at an ISI of 10 milliseconds. Ten stimuli will be applied at each condition (unconditioned pulse and pairs of stimuli with ISI of 2 and 10 milliseconds). Stimuli order delivery will be pseudo-randomized and SICI and ICF will be expressed as conditioned stimulus percentage regarding an unconditioned stimulus.
16045237|NCT02559505|Biological|Seasonal IIV 0.25 mL dose|Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age
16045238|NCT02559505|Other|Natural influenza infection|Children enrolled on presentation to their primary care provider with a natural influenza infection
16045239|NCT02559505|Biological|Seasonal IIV 0.5 mL dose|Fluzone (Sanofi Pasteur) 0.25 mL administered intramuscularly to children between 6 and 35 months of age
16045240|NCT02559492|Drug|Itacitinib|Itacitinib (INCB039110) tablets will be administered orally once daily in the morning.
16045241|NCT02559492|Drug|Epacadostat|Epacadostat tablets will be administered orally, twice daily.
16045242|NCT02559492|Drug|Itacitinib|Itacitinib (INCB039110) tablets will be administered orally once daily in the morning.
16045243|NCT02559492|Drug|INCB050465|INCB050465 tablets will be administered orally once daily.
16045244|NCT02559479|Behavioral|Weight loss interventional study with a low-calorie 18%-protein diet|
16045245|NCT02559479|Behavioral|Weight loss interventional study with a low-calorie 35%-protein diet|
16045246|NCT02559466|Device|Transcranial Magnetic Stimulation (TMS - ) - MagPro®|Class IIa
16045247|NCT02559466|Device|Positon Emission Tomography (PET) - Discovery 710®|Class IB
16045249|NCT02559440|Drug|mometasone furoate|50μg, 1 puff in each nostril every evening
16045250|NCT02559440|Drug|Placebo|1 puff in each nostril every evening
16045251|NCT02559440|Drug|Oxymetazoline + Placebo|1 puff of Oxymetazoline +1 puff of Placebo in each nostril every evening
16045252|NCT02559440|Drug|Placebo + placebo|1 puff of placebo +1 puff of Placebo in each nostril every evening
16045253|NCT02559440|Drug|mometasone furoate + Placebo|1 puff of mometasone furoate +1 puff of Placebo in each nostril every evening
16045254|NCT02559440|Drug|mometasone furoate + Oxymetazoline|1 puff of mometasone furoate +1 puff of Oxymetazoline in each nostril every evening
16045255|NCT02559427|Other|3-week immediate SPA treatment|a comprehensive program soon after randomization including sessions of balneotherapy, diet information, exercise training. The most adapted to the concerned pathology and common to all SPA resorts (walk in a specially pool, whirlpool bath with automatic air and water massages cycles, massages shower...)
16045256|NCT02559427|Other|3-week late SPA treatment|a comprehensive program after 4.5 months, including sessions of balneotherapy, diet information, exercise training. The most adapted to the concerned pathology and common to all SPA resorts (walk in a specially pool, whirlpool bath with automatic air and water massages cycles, massages shower...)
16045257|NCT02559414|Drug|Aspirin|
16045258|NCT02559414|Drug|Clopidogrel|
16045259|NCT02559401|Other|MRI|
16045260|NCT02559401|Other|Neurocognitive battery|
16045261|NCT02559388|Drug|Montelukast|
16045262|NCT02559388|Drug|placebo|Placebo (For Montelukast) Placebo pills manufactured for mimic 10 milligram montelukast pills
16045263|NCT02559375|Other|Survey|
16045264|NCT02559362|Behavioral|Survey|
16045265|NCT02559349|Other|Stool Collection|
16045266|NCT02559336|Other|Integrated palliative oncology care|Integrated palliative care and oncology care for advanced cancer patients who have an unplanned admission to hospital
16045267|NCT02559323|Other|Survey|
16045268|NCT02559310|Drug|lefamulin|antibacterial agent
16045269|NCT02559310|Drug|Moxifloxacin|antibacterial agent
16045270|NCT02559310|Drug|Linezolid|antibacterial agent
16045271|NCT02559297|Drug|Sevoflurane|After induction of anesthesia and successful intubation, 2 L/min N2O, 2 L/min O2 , and 2% to 2.5% sevoflurane will be given for 10 minutes then total flow will be decreased to 2 L/min. Anesthesia will be maintained using 1-1.5 minimal alveolar concentration (MAC) of sevoflurane in 50% O2 and 50% N2O. Ventilation will be adjusted to keep end-tidal carbon dioxide 30-35 mmHg (Tidal volume 7-10 mL/kg).
16045272|NCT02559297|Drug|Desflurane|After induction of anesthesia and successful intubation, 2 L/min N2O, 2 L/min O2 , and 6% to 8% desflurane will be given for 10 minutes then total flow will be decreased to 2 L/min. Anesthesia will be maintained using 1-1.5 minimal alveolar concentration (MAC) of desflurane in 50% O2 and 50% N2O. Ventilation will be adjusted to keep end-tidal carbon dioxide 30-35 mmHg (Tidal volume 7-10 mL/kg).
16045273|NCT02559284|Other|A postoperative care after ethmoid sinus surgery|"A comparison of two products used for nasal cavity cleansing, at the rate of 4 washes/day (240mL per wash), as local postoperative care following endoscopic sinus surgery. This surgery, known as an ethmoidectomy, aims to improve sinus ventilation, treat the chronically infected area, and remove polyps that cause nasal obstruction.
~Detailed information concerning the purpose of nasal irrigation, as well as how to use and clean the device, will be given to patients upon inclusion.
~The nasal washing procedure will be as follow:
~Washing both nostrils using 180mL of solution distributed equally on each side to remove crusting and clotting
~Gentle blowing of the nose
~Rinsing both nostrils with the remaining 60mL of solution distributed equally on each side (no nose-blowing)."
16045274|NCT02559258|Drug|0.1 mg/kg epsi-gam or placebo (6:2)|administered as a single intravenous infusion on Day 1, infused over 30 minutes
16045275|NCT02559258|Drug|0.3 mg/kg epsi-gam or placebo (6:2)|administered as a single intravenous infusion on Day 1 infused over 30 minutes
16045276|NCT02559258|Drug|1.0 mg/kg epsi-gam or placebo (6:2)|administered as a single intravenous infusion on Day 1 infused over 30 minutes
16045277|NCT02559258|Drug|3 mg/kg epsi-gam or placebo (6:2)|administered as a single intravenous infusion on Day 1 infused over 60 minutes
16045278|NCT02559258|Drug|10 mg/kg epsi-gam or placebo (6:2)|administered as a single intravenous infusion on Day 1 infused over 120 minutes
16045279|NCT02559245|Other|Descurainia Sophia|
16045280|NCT02559245|Other|Ficus carica|
16045281|NCT02559232|Drug|Direct Oral Anticoagulant (DOAC)|Treatment pattern following the summary of product characteristics
16045282|NCT02559219|Other|Questionniares|
16045283|NCT02559206|Drug|Linaclotide|Oral, once daily
16045284|NCT02559206|Drug|Matching Placebo|Oral, once daily
16045285|NCT02559193|Other|Observational study, data collection only trial.|Data collection only trial design.
16045286|NCT02559180|Drug|aflibercept|aflibercept 2mg given intravitreally every month until resolution of fluid in retina and then continued every 2 months for a total of 24 months of treatment
16045287|NCT02559167|Drug|Cannabidiol|The investigators will carry out a double-blind, randomized, controlled trial comparing the effects of 92 days of 400 (only for the first 2 Days starting on the Day 2 of the study) or 800 mg CBD (subjects who report side effects with the 800mg dose will be administered the CBD 400 mg dose for the remainder of the trial) vs. placebo administration on cocaine craving and relapse in 110 cocaine-dependent subjects.
16045288|NCT02559154|Drug|Bortezomib|
16045289|NCT02559154|Drug|Dexamethasone|
16045290|NCT02559154|Drug|Doxorubicin|
16045291|NCT02559154|Drug|Cyclophosphamide|
16045292|NCT02559154|Drug|Mitoxsnteone|
16045293|NCT02559154|Drug|Thalidomide|
16045294|NCT02559141|Drug|Dobutamine|If PPV ≤10%, volume substitution of 500 ml of crystalloids and/or colloids as long as CI was ≥2.5 l/min/m². Maintenance of CI ≥2.5 l/min/m² and MAP ≥65 mmHg was achieved by using dobutamine (10 µg/kg/min) and norepinephrine (0.03 µg/kg/min).
16045295|NCT02559115|Radiation|68Ga-RM2 (RM2)|
16045296|NCT02559115|Device|PET/CT Scan|
16045297|NCT02559102|Drug|Dexmedetomidine sedation|Patients receive dexmedetomidine sedation
16045298|NCT02559102|Drug|General sevoflurane anaesthesia|Patients receive general sevoflurane anaesthesia with endotracheal intubation
16045299|NCT02559102|Procedure|Caudal anaesthesia|single shot caudal anaesthesia
16045300|NCT02559102|Procedure|Inguinal hernia surgery|Infant inguinal hernia repair.
16045301|NCT02559076|Behavioral|Ten Steps leaflet advice for healthy lifestyle|Ten steps leaflet advice for healthy lifestyle
16045302|NCT02559063|Behavioral|Vision-based speed of processing training|computerized cognitive tasks addressing vision-based speed of processing
16045303|NCT02559063|Behavioral|Mental leisure activities|computerized cognitive tasks addressing different aspects of executive function
16045304|NCT02559050|Other|Customized 3D-printed nasal stent|Silicone stent with unconventional shape, 3D-printed based on patient's computed topographical images, to exactly fit newly made nasal cavity.
16045305|NCT02559037|Device|Acupuncture and moxibustion|"Acupuncture acupoints: CV12, bilateral ST36, ST37, SP6, SP9, SP4, LR3 and LI3. Disposable acupuncture auxiliary device and 0.30*40mm or 0.30*25mm acupuncture needles (hwato, suzhou medical supplies factory co., LTD.) were used. The needles were directly inserted 20-30mm into the skin and elicited a de-qi sensation. The needle was kept for 30 min.
~Moxibustion acupoints: bilateral ST25 and ST36. Using mild-warm moxibustion, The surface temperature of acupoints were maintained at 43 ℃ ± 1 ℃, 30min for each acupoint. Moxibustion and acupuncture were performed at the same time, once every other day, three times a week, a total of 12 weeks of treatment. After the treatment, subjects were followed up in the weeks 24, 36 and 48."
16045306|NCT02559037|Device|Sham acupuncture and moxibustion|"The acupoints used are same to the experimental group. Same disposable acupuncture auxiliary device and 0.35 * 40mm acupuncture needle (flat and blunt needle tip, Hwato, Suzhou Medical Supplies Factory Co., Ltd.) was selected. When the needle was pricked to the acupoint, it did not penetrating into the skin. The subject only felt slight pain and do not have the de-qi sensation.
~Sham moxibustion : by using the same moxa stick, The surface temperature of acupoints were maintained at 37 ℃ ± 1 ℃, 30min for each acupoint. Sham acupuncture and sham moxibustion were performed at the same time. They were treated once every other day, three times a week, a total of 12 weeks. After the treatment, subjects were followed up in the weeks 24, 36 and 48."
16045307|NCT02559024|Drug|MEDI6469|MEDI6469 0.4 mg/kg IV x 3 doses over 5-6 days
16045308|NCT02558998|Other|Survey|
16045309|NCT02558985|Procedure|Casting|Serial casting is used to partially correct the deformity before beginning bracing. A cast can be considered a full-time brace which cannot be removed.
16045310|NCT02558972|Drug|Northera (Droxidopa)|Study #1 -Supine monitoring is performed for 30 minutes before administration of a single 600mg oral dose of Northera or placebo assigned randomly, After 2 hours supine a 70 degree upright tilt will performed for 10 minutes. On another day, subjects previously given Northera will receive placebo and vice versa and studies repeated.
16045311|NCT02558972|Drug|Placebo|Study #1 -Supine monitoring is performed for 30 minutes before administration of a single 600mg oral dose of Northera or placebo assigned randomly, After 2 hours supine a 70 degree upright tilt will performed for 10 minutes. On another day, subjects previously given Northera will receive placebo and vice versa and studies repeated.
16045312|NCT02558972|Drug|Northera (Droxidopa)|Study #2 -Patients will randomized to receive Northera or placebo for two weeks after which they will return for instrumented tilt studies as in Study 1. Doses of Northera will be titrated upwards by 100mg/dose every 48 hours from a starting dose of 100mg three times a day to a maximum of 600mg three times a day. Doses will be reduced to the preceding dose if systolic BP>140mmHg or diastolic BP>80mmHg measured in the seated position at home using an automated ambulatory blood pressure cuff 2 hours after receiving an oral dose. Doses will also be reduced if supine BP measured with the head of the bed elevated upon awakening in the morning exceeds 150/90 mmHg. Following a 1 week wash out period, subjects will receive the alternative treatment for 2 additional weeks and instrumented laboratory studies repeated.
16045313|NCT02558972|Drug|Placebo|Study #2 -Patients will randomized to receive Northera or placebo for two weeks after which they will return for instrumented tilt studies as in Study 1. Doses of Northera will be titrated upwards by 100mg/dose every 48 hours from a starting dose of 100mg three times a day to a maximum of 600mg three times a day. Doses will be reduced to the preceding dose if systolic BP>140mmHg or diastolic BP>80mmHg measured in the seated position at home using an automated ambulatory blood pressure cuff 2 hours after receiving an oral dose. Doses will also be reduced if supine BP measured with the head of the bed elevated upon awakening in the morning exceeds 150/90 mmHg. Following a 1 week wash out period, subjects will receive the alternative treatment for 2 additional weeks and instrumented laboratory studies repeated.
16045314|NCT02558959|Drug|Irinotecan|
16045315|NCT02558959|Drug|Capecitabine|
16045316|NCT02558946|Behavioral|Pelvic Floor Muscle Physical Therapy|The treatment group will receive pelvic floor muscle training through a course of three one-hour sessions with a trained pelvic floor physical therapist in addition to the current standard information from their surgeon. The physical therapy sessions will be conducted at 1-6 weeks preoperative, 1 week postoperative, and 4-6 weeks postoperative and will be coordinated with surgeon appointments to minimize any inconvenience and travel time.
16045317|NCT02558946|Behavioral|Control Group|At the cancer consultation visit, subjects will be educated by the urologist or urology team member regarding surgical and postoperative expectations. At this time, subjects will be provided verbal instruction and written information regarding Kegel exercises. Subjects in the control group may decide the duration and frequency of home exercise performance.
16045318|NCT02558933|Dietary Supplement|Epigallocatechin gallate|Pre and post study, non randomized, controlled and without placebo, to evaluate the efficacy of Epigallocatechin gallate (EGCG). It is a pilot study in a cohort of 40 FAS children, between 7 ans 14 years old. An oral dose of 9 mg/Kg/day will be administered during 1 year, with 6 control visits until 6 months after finishing the treatment.
16045319|NCT02558920|Other|Fructose-containing Sugars|An intervention in which calories from food sources of fructose-containing sugars are substituted, added, subtracted, or replaced ad libitum in the diet
16045320|NCT02558907|Other|cognitive evaluation by MMS (Mini-Mental State Examination) and MoCA (Montreal Cognitive Assessment) tests|
16045321|NCT02558894|Drug|MEDI4736 monotherapy|MEDI4736 via IV infusion.
16045322|NCT02558894|Drug|tremelimumab+MEDI4736|tremelimumab+MEDI4736 via IV infusion.
16045323|NCT02558881|Procedure|Virtual colonoscopy|
16045324|NCT02558881|Procedure|Colon capsule|
16045325|NCT02558868|Drug|Irinotecan|
16045326|NCT02558868|Drug|Oxaliplatin|
16045327|NCT02558855|Other|Thrust Joint Manipulation of the Lumbar Spine|
16045328|NCT02558855|Other|Non-thrust Joint Manipulation of the Lumbar Spine|
16045329|NCT02558842|Other|Education Strategy|"Interview with the patient and their contacts, even during hospitalization, Delivering educational material about TB distribution free; Advise the patient about the BHU nearest their home, where it will follow the treatment of tuberculosis. Provide the address and telephone contact BHU this writing.
~During the time of TB treatment, contact the patient to see if it is adhering to treatment and answer questions about the disease and treatment, The contact will be performed weekly for the first month, biweekly for the other months.
~During the treatment period, contact BHU to monitor the progress of the case. Monitoring will be terminated: when the patient is discharged after cure of BHU or when the patient is absent for more than 30 days from the last scheduled visit."
16045330|NCT02558829|Drug|Macimorelin|macimorelin acetate, 0.5 mg/kg body weight, drinking solution, single dose
16045331|NCT02558829|Drug|Insulin|Insulin, 0.10 U/kg (0.15 U/kg if BMI > 30 kg/m2), intravenous injection, single dose
16045332|NCT02558816|Drug|Ibrutinib + GA101 +GDC-0199|Step A : 9 patients receive the combination of Ibrutinib + GA101 Step B : 24 patients receive the combination of Ibrutinib + GA101 + GDC-0199 Step C : 15 untreated patients receive the combination of Ibrutinib + GA101 + GDC-0199
16045333|NCT02558803|Behavioral|Simple Reminder|A simple reminder prompt in which CHICA will provide an immunization reminder to the physician that the child is eligible for the 2nd or 3rd dose of vaccine.
16045334|NCT02558790|Drug|L-Threonic Acid Magnesium Salt (L-TAMS)|
16045335|NCT02558777|Other|Multicomponent nurse-led intervention|"Participants in the intervention group received the first intervention in the first 24 hours from admission, and thereafter daily until hospital discharge. The intervention was carried out exclusively by the intervention nurses, and was composed of two main parts, being the first one a risk factor analysis, and the second one the intervention on the risk factors detected (orientation, sensorial deficit, sleep, mobilization, hydration, nutrition, drugs, elimination, oxygenation, pain). Furthermore, the intervention nurses identified the principal caregiver in the first 24 hours from admission, and provided an informative booklet about strategies and recommendations to prevent delirium incidence, including ambient strategies, orientation abilities, and identification of alert signs."
16045336|NCT02558764|Device|portable (pocket) negative pressure wound treatment device|PICO device will be applied to the surgical wounds of kidney transplant patients who are enrolled in the PICO group. These patients will have this device on for 7 days after undergoing kidney transplant surgery.
16045337|NCT02558751|Biological|23-valent pneumococcal polysaccharide vaccine|One standard adult dose of the 23-valent pneumococcal polysaccharide vaccine
16045338|NCT02558751|Biological|13-valent pneumococcal conjugate vaccine|One dose of the 13-valent pneumococcal conjugate vaccine, PCV13, followed 8 weeks later by one dose of the 23-valent pneumococcal polysaccharide vaccine, PPV23.
16045339|NCT02558738|Device|ear spray|
16045340|NCT02558725|Drug|two capsules of aktiferrin F|two capsules of Aktiferrin F or Foliferrin
16045341|NCT02558712|Other|Technology-based Eye Care Services (TECS) Protocol|Extensive History will be taken. Distance auto-refraction measurements will be made on both eyes. Eye pressure using the iCare tonometer and central corneal thickness (CCT) using the corneal pachymeter will be taken for each eye. Participants will have fundus photos taken following the standard VA diabetic teleretinal protocol. Then participants will have OCT Macula and Nerve performed. After protocol complete, then patients will see an ophthalmologist for standard eye exam.
16045342|NCT02558699|Procedure|physician's personal experience|physician's personal experience
16045343|NCT02558699|Procedure|Virtual rotor mapping|Virtual rotor mapping
16045344|NCT02558686|Other|Eccentric Exercise|Individuals will perform 3 sets of 10 repetitions of eccentric exercise of the infraspinatus muscle after the application of trigger point dry needling
16045345|NCT02558686|Other|Detuned Ultrasound|Individuals will received 10 minutes of detuned ultrasound on the infraspinatus muscle after the application of trigger point dry needling
16045346|NCT02558686|Other|Placebo|Individuals will not perform any action after the application of trigger point dry needling
16045347|NCT02558673|Other|TMAO dietary precursors|
16045348|NCT02558673|Other|Control (or active comparator)|
16045349|NCT02558660|Behavioral|Education|Educational intervention about an existing SNAP healthy food incentive program
16045350|NCT02558660|Behavioral|voucher|$10 voucher to spend on produce at farmers markets
16045351|NCT02558647|Behavioral|CBT for insomnia (CBT-I)|CBT-I is an online, fully automated, interactive, and tailored web-based program that incorporates the primary tenets of face-to-face CBT-I, including sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention.
16045352|NCT02558647|Behavioral|Psycho-Education about Sleep (PE)|PE provides online information about insomnia symptoms; the impact, prevalence, and causes of insomnia; when to seek input from a doctor; and basic lifestyle, environmental, and behavioral strategies that may help to improve sleep.
16045353|NCT02558634|Device|VIM Thalamic Deep Brain Stimulation ON|
16045354|NCT02558634|Device|VIM Thalamic Deep Brain Stimulation OFF|
16045355|NCT02558621|Device|AQrate Robotic Assistance System|Robotic guidance during spinal fusion surgery
16045356|NCT02558608|Procedure|DIPL|dissection of the inferior pulmonary ligament
16045357|NCT02558608|Procedure|WR|wedge resection of the lung bleb
16045358|NCT02558608|Procedure|thoracoscopic surgery|surgery performed by video assisted thoracoscopy
16045359|NCT02558595|Dietary Supplement|Niacinamide|
16045360|NCT02558595|Other|Placebo|Placebo pill that matches niacinamide pill is size, shape and color
16045361|NCT02558582|Behavioral|respiratory and exercise therapy|The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training.
16045362|NCT02558582|Behavioral|respiratory and exercise therapy with supplemental oxygen|"The PH specific rehabilitation consists of: bicycle ergometer training, respiratory training, dumbbell-training and (mental) gait training.
~Patients who are not already under long-term oxygen therapy (LTOT) due to daytime hypoxemia will additionally be randomized to receive standardized supplemental oxygen therapy (SSOT) during training and nights."
16045363|NCT02558569|Drug|Levobupivacaine|L form of bupivacaine with less cardiotoxicity.
16045364|NCT02558569|Other|NSS|Clear intravenous fluid looks alike local anesthetic.
16045445|NCT02557893|Behavioral|Resistance exercise|Resistance exercise involved 12-weeks of strength training twice per week
16045365|NCT02558556|Device|Laparoscopic Fluorescence Imaging System (Karl Storz)|The Laparoscopic Fluorescence Imaging System (incl. laparoscope, light source, light cable) will supply the needs for near-infrared fluorescence imaging with ICG. The hypothesis is that this device will help in visualizing the anatomical structures such as the common bile duct, which are hard to visualize in white light due to the surrounding tissues.
16045366|NCT02558556|Other|Indocyanine Green|Indocyanine Green will be injected intravenously as a contrast agent for the use of the Laparoscopic Fluorescence Imaging System.
16045367|NCT02558543|Drug|Stromal Vascular fraction|
16045368|NCT02558543|Drug|Ringer lactate|
16045369|NCT02558530|Other|Low carbohydrate diet|Isocaloric, carbohydrate restricted diet 14 days
16045370|NCT02558517|Drug|prednisone discontinuation|randomization
16045371|NCT02558504|Procedure|Oesophagectomy|
16045372|NCT02558504|Device|Radiofrequency ablation|
16045373|NCT02558491|Device|Decision Support System|"The purpose of this study is to demonstrate the safety and feasibility of a Decision Support System aimed at reducing glucose variability in T1DM patient using an insulin pump. The system will be deployed on our portable medical application platform (DiAs) and will include the following elements:
~An insulin pump treatment parameters optimization routine, using a month of collected CGM/insulin/meal data
~An exercise risk warning system, capable of predicting hypoglycemia at the onset of physical activity and advising on mitigating alteration of treatment."
16045374|NCT02558478|Genetic|blood sampling|
16045375|NCT02558465|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Treatment parameters following the summary of product characteristics and the physician's decision
16045376|NCT02558452|Drug|Tacrolimus once daily (Advagraf)|Antibody induction by antithymocyte Globulin (ATG) or Basiliximab possible but not mandatory
16045377|NCT02558439|Drug|CNTX-4975|
16045378|NCT02558439|Other|Placebo|
16045379|NCT02558426|Procedure|Venous Surgery|Patients with Varicose Veins will undergo to venous surgery procedure. Samples obtained from patients undergoing surgical removal of varicose veins will be collected and immediately preserved at -80°. Briefly, the venous tissueswill be excised, homogenized with a motor-driven homogenizer and total RNA will be isolated using the Trizol reagent (Invitrogen, Milan, Italy), according to the manufacturer's instructions. The expression of ERα, ERβ and GPER will be quantified by real-time PCR using the Step OneTM sequence detection system (Applied Biosystems Inc., Milan, Italy), following the manufacturer's instructions
16045380|NCT02558413|Drug|BTA-C585 oral capsules|BTA-C585; Single ascending doses from 50 mg to 800 mg
16045381|NCT02558413|Drug|BTA-C585 matching placebo|Single ascending doses to match 50 to 800 mg BTA-C585 capsules
16045382|NCT02558400|Drug|PG324 Ophthalmic Solution 0.02%/0.005%|1 drop once daily (QD), in the evening (PM) in both eyes (OU)
16045383|NCT02558400|Drug|Netarsudil (AR-13324) Ophthalmic Solution 0.02%|1 drop once daily (QD), in the evening (PM) in both eyes (OU)
16045384|NCT02558400|Drug|Latanoprost Ophthalmic Solution 0.005%|1 drop once daily (QD), in the evening (PM) in both eyes (OU)
16045385|NCT02558387|Drug|BIBF1120|Nintedanib will be given orally at a dose of 200mg twice daily (bid) until progression or unacceptable toxicity.
16045386|NCT02558374|Drug|AR-13324 Ophthalmic Solution 0.02%|1 drop once daily (QD), PM, OU
16045387|NCT02558374|Drug|Timolol Maleate Ophthalmic Solution 0.5% BID|1 drop BID, AM/PM, OU
16045388|NCT02558374|Other|Placebo|1 drop QD, AM, OU
16045389|NCT02558361|Drug|Treatment with Apremilast|Standard dosing with apremilast (Otezla) will be used. [30mg po BID after initial titration]
16045390|NCT02558348|Drug|AL3818|Administered orally
16045391|NCT02558322|Other|Primary medical care|All study participants receive primary care as usual in the respective region
16045392|NCT02558296|Drug|Bexagliflozin|20 mg, tablet
16045393|NCT02558296|Drug|Placebo|20 mg tablet to match active comparator
16045394|NCT02558283|Device|JUVÉDERM® VOLIFT® with Lidocaine|JUVÉDERM® VOLIFT® with lidocaine injected into the nasolabial fold on Day 1, with optional touch-up injections into the nasolabial fold on Month 1.
16045395|NCT02558283|Device|Restylane®|Restylane® injected into the nasolabial fold on Day 1, with optional touch-up injections into the nasolabial fold on Month 1.
16045396|NCT02558270|Drug|Dapagliflozin|
16045397|NCT02558270|Drug|Placebo|
16045398|NCT02558257|Behavioral|Survey|Participants complete palliative care survey within 1 week +/- 4 days of initial consultation via phone survey conducted by Research nurse/assistant.
16045399|NCT02558231|Drug|Macitentan|Used open-label in both arms, 10 mg tablet, 1 tablet u.i.d.
16045400|NCT02558231|Drug|Tadalafil|Used open-label in both arms, 20 mg tablet, 1-2 tablets u.i.d.
16045401|NCT02558231|Drug|Selexipag|Used double-blind in the triple oral treatment arm, 200 microgram tablet, 1-8 tablets b.i.d.
16045402|NCT02558218|Drug|Systane Ultra|Further to standard medication (tobradex quid for 20 days), participants were administered Systane Ultra quid for 2 months
16045403|NCT02558218|Drug|tobradex quid (Standard)|Standard medication (tobradex quid for 20 days)
16045404|NCT02558205|Radiation|CT Liver Perfusion|Imaging study of liver using injection of Iodine contrast agent done using CT imaging
16045405|NCT02558205|Radiation|PET/CT of liver|PET/CT of liver following Y-90 treatment. PET/CT imaging uses positron decay of Y-90 to detect distribution of Y-90 in the liver.
16045406|NCT02558192|Dietary Supplement|Lactobacillus Rhamnosus GG|1 vials q12 for 15 days
16045407|NCT02558192|Dietary Supplement|PLACEBO|1 vials q12 for 15 days
16045408|NCT02558153|Device|DEB, drug eluting balloon|Percutaneous angioplasty performed with a DEB - drug eluting balloon
16045409|NCT02558153|Device|standard PTA|Percutaneous angioplasty performed with a standard balloon
16045410|NCT02558140|Biological|RO6874813|RO6874813 will be administered at a single low dose of 0.5 mg/kg via IV infusion in a 7- day PK run-in period (Cycle 0). Dose level for RO6874813 will be escalated to determine MTD and RP2D for RO6874813.
16045411|NCT02558140|Biological|RO6874813|RO6874813 at RP2D will be administered by IV infusion as per dosing schedule determined in Part 1.
16045446|NCT02557893|Other|Education|Bimonthly pregnancy education classes
16045447|NCT02557893|Other|Wait list|Wait list participants were tested on the outcomes during their pregnancy and were eligible to participate in a post-partum supervised exercise program. The wait list participants formed a no treatment control group.
16045412|NCT02558127|Genetic|Asthma patients|Patients with inclusion criteria, following examinations: a study of lung function measurement of the fraction of nitric oxide in exhaled air, induced sputum, sputum, and extraction of peripheral venous blood for Study of genetic variants in the CFTR gene,skin prick test . The number of eosinophils in peripheral blood by automated cell counting and Total IgE by ELISA were measured. Furthermore, the level of asthma control be assessed by validated symptom questionnaire Asthma Control Test, quality of life is determined by the MiniAQLQ questionnaire.
16045413|NCT02558114|Drug|Ribavirin|
16045414|NCT02558101|Behavioral|Control invitation materials|"In the absence of usual care screening invitation materials, the control invitation materials and strategy are based upon the best available materials and methods of existing cancer screening programmes. These are comprised of the following:
~a pre-invitation letter notifying patients of the lung health check service and an information booklet mimicking those of existing screening programmes
~an invitation letter with a pre-scheduled appointment plus the same information booklet
~a reminder re-invitation letter for those who miss their appointment without cancelling"
16045415|NCT02558101|Behavioral|Intervention invitation materials|The intervention invitation strategy is comprised of the same stages of invitation materials as the control group. The two differences are i) Instead of the information booklet they will received a targeted leaflet, and ii) the invitation and reminder letters will use indirect phrasing to explain that smokers and ex-smokers are being invited. Together, these manipulations aim to deliver a targeted, stepped and low burden approach to information provision prior to the appointment.
16045416|NCT02558088|Drug|Salmeterol|
16045417|NCT02558075|Behavioral|MoodLifters Sessions|This program consists of 15 different sessions with a different topic for each session. These sessions will occur once a week for 15 weeks and will last approximately an hour each. These topics will be in one of five theoretically important areas: biological, cognitive, affective, behavioral and social. Each subsequent week will involve an in-depth exploration of each topic, including why it is important to mental well-being and practical ideas about how to implement positive changes into one's everyday life. Following the facilitator's brief presentation, group members will be invited to share their experiences, challenges, and provide peer support.
16045418|NCT02558062|Other|BAC ONE administration|BAC ONE will be administered to each patient during a bronchoscopy procedure. Fibre-based endomicroscopy and Cellvizio viewer software will be used to detect BAC ONE signal in the distal lung.
16045419|NCT02558049|Other|Decision aid|Participants will receive a patient decision aid which outlines the potential benefits and harms of proton pump inhibitor use, as well as the potential benefits and harms of switching to a lower dose of PPI or stopping and using on-demand (only when symptoms occur). The decision aid also allows participants to clarify their values regarding these potential benefits and harms.
16045420|NCT02558036|Other|C-Mac D-Blade Videolaryngoscope|Using C-Mac D-Blade Videolaryngoscope patients will be positioned the neutral Head and Neck Position
16045421|NCT02558036|Other|C-Mac D-Blade Videolaryngoscope|Using C-Mac D-Blade Videolaryngoscope patients will be positioned in Sniffing Head and Neck Position
16045422|NCT02558036|Other|King Vision Videolaryngoscope|Using the King Vision Videolaryngoscope patients will be positioned in the neutral Head and Neck Position
16045423|NCT02558036|Other|King Vision Videolaryngoscope|Using the King Vision Videolaryngoscope patients will be positioned in Sniffing Head and Neck Position
16045424|NCT02558023|Drug|Urapidil|"Urapidil (Eupressyl*) : IV One initial iv bolus of 12.5 mg. One or more bolus of 6.25 mg at intervals of 5 minutes if the diastolic pressure remains above 100 mmHg.
~The treatment is then continued at 4 mg.h-1 iv via a syringe pump. The maintenance dose needed to maintain MAP between 100 and 120 mmHg is sought by adjustments of ± 2 mg.h-1every 5 minutes.
~Maximum dose of 30 mg.h-1."
16045425|NCT02558023|Drug|Nicardipine|"Nicardipine : IV
~1 mcg.kg-1.min-1until reduction MAP 15%. Reduction 1/4 of the posology (0.75 mcg.kg -1.min-1). The maintenance dose needed to maintain MAP between 100 and 120 mmHg is then sought by adjustments of ± 0.25 mcg.kg.min-1every 5 minutes.
~Maximum dose of 6 mg.h-1"
16045426|NCT02558010|Drug|Methadone|Perioperative IV methadone to be given
16045427|NCT02558010|Other|Normal Saline|control arm
16045428|NCT02558010|Drug|Morphine|Both groups will receive morphine via Patient-Controlled Analgesia (PCA) pump.
16045429|NCT02557997|Other|Blood tube bottom analyses|
16045430|NCT02557984|Drug|Placebo|Placebo Pill
16045431|NCT02557984|Drug|Amisulpride|400 mg Amisulpride
16045432|NCT02557984|Drug|Naltrexone|50 mg Naltrexone
16045433|NCT02557971|Drug|onabotulinumtoxinA|OnabotulinumtoxinA (BOTOX®) as prescribed in clinical practice.
16045434|NCT02557958|Drug|Azithromycin|We hypothesize that in patients with COPD, treatment with azithromycin will show reduced inflammatory markers, transcription factors changes, and lung function changes consistent with reduced inflammation.
16045435|NCT02557958|Drug|Placebo|We hypothesize that in patients with COPD, treatment with placebo will show NO change in inflammatory markers, transcription factor changes and lung function from baseline.
16045436|NCT02557945|Drug|Gabapentin|Subjects will be treated with 400mg pills of gabapentin , titrating up to 3600mg per day, or 9 tablets (3 tabs tid)
16045437|NCT02557945|Drug|Placebo|Subjects will be treated with 400mg pills of placebo, titrating up to 3600mg per day, or 9 tablets (3 tabs tid)
16045438|NCT02557932|Drug|Standard triple therapy|Lansoprazole 30mg, 2 times a day + Clarithromycin 500mg, 2 times a day + Amoxicillin 1000mg, 2 times a day for 7 days
16045439|NCT02557932|Drug|Bismuth quadruple therapy|Lansoprazole 30mg, 2 times a day + Bismuth 300mg, 4 times a day + Tetracycline 500mg, 4 times a day + Metronidazole 500mg, 3 times a day for 10 days
16045440|NCT02557919|Other|Motivational Interviewing Training|1.5 day training on Motivational Interviewing (MI) techniques plus 2 booster sessions to address real experiences using MI with families.
16045441|NCT02557919|Other|Usual Best Practice|.5 day training on tobacco control and emerging products.
16045442|NCT02557906|Procedure|Breast reconstruction - implant and an ADM (SurgiMend)|Skin or nipple sparing mastectomy and immediate breast reconstruction with implants and SurgiMend
16045443|NCT02557906|Procedure|Breast reconstruction- autologous tissue|Skin or nipple sparing mastectomy and immediate breast reconstruction with autologous tissue
16045444|NCT02557906|Procedure|Breast reconstruction- implant + dermal sling/LD flap|Skin or nipple sparing mastectomy and immediate breast reconstruction using an implant and a dermal sling or a latissimus dorsi flap
16045448|NCT02557880|Behavioral|Sleep Application Diary|Tool used to document sleep hygiene.
16045449|NCT02557880|Behavioral|Treatment As Usual|Sleep hygiene counseling
16045450|NCT02557867|Drug|Dexmedetomidine|Dexmedetomidine 0.5 μg/kg over 10 minutes and then, 0.5 mcg/kg/h throughout surgery.
16045451|NCT02557854|Drug|Doxorubicin HCl liposomal injection|50mg IV every 4 weeks
16045452|NCT02557854|Device|Philips Sonalleve MR-HIFU Hyperthermia|Hyperthermia to 42C for 30 minutes every 4 weeks
16045453|NCT02557841|Device|tDCS|Current will be applied by a DC stimulator (NeuroConn Plus, Germany).The active electrode (anode: 5x7 cm²) will be placed over the left cerebellar hemisphere (3 cm lateral to the inion) and the reference (5x7 cm²), over the left arm with current intensity of 2mA, fade in and fade out of 10 seconds, during 20 minutes.
16045454|NCT02557841|Device|tDCS|Current will be applied by a DC stimulator (NeuroConn Plus, Germany). The active electrode (cathode: 5x7 cm²) will be placed over the left cerebellar hemisphere (3 cm lateral to the inion) and the reference (5x7 cm²), over the left arm with current intensity of 2mA, fade in and fade out of 10 seconds, during 20 minutes.
16045455|NCT02557841|Device|tDCS|Sham ctDCS (NeuroConn Plus, Germany) will be applied at the same parameter settings used on cathodal ctDCS however, current duration will be only 30 seconds. Moreover, device automatically turned off without volunteer's perception, but volunteers will be with electrodes montage for 20 minutes.
16045456|NCT02557828|Procedure|arterial line placement|radial arterial cannulation placed via palpation or ultrasound technique
16045457|NCT02557815|Device|Repetitive Transcranial Magnetic Stimulation|Repetitive 10Hz right DLPFC stimulation using Magstim TMS apparatus
16045458|NCT02557802|Biological|Fluenz Tetra|Intranasal spray, 0.2 ml dose
16045459|NCT02557802|Biological|Fluarix Tetra|Intramuscular injection, 0.5 ml dose
16045460|NCT02557789|Drug|Lefamulin|Lefamulin administered iv or orally in the fasted state and orally in the fed state
16045461|NCT02557776|Genetic|Germline genetic testing of BRCA1 and BRCA2|
16045462|NCT02557763|Device|Oxford unicompartmental knee arthroplasty|The patients with medial osteoarthritis knee with patellofemoral arthritis were performed surgery and applied Oxford unicompartmental knee arthroplasty.
16045463|NCT02557737|Drug|Botulinum Toxin Type A|To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Ultrasonography direct-guidance, Ultrasonography direct-guidance, Electric stimulation and Surface anatomy landmark.
16045464|NCT02557724|Procedure|blood samples|liver transplant patients will have (5) 3cc blood samples drawn at specific time points.
16045465|NCT02557724|Procedure|blood samples|liver resection patients will have (3) 3cc. blood samples drawn at specific time points
16045466|NCT02557711|Device|ultrasound elastography, acoustic radiation force impulse|Two physiatrists will perform ultrasound elastography and ARFI for intra-rater and inter-rater reliability evaluation.
16045467|NCT02557698|Other|Balneum oil bath|
16045468|NCT02557685|Biological|Fecal Microbiota Transplantation|Fecal Microbiota Translantation involves administering fecal material from a healthy donor to a sick patient, with relapsing C-difficile infection, to restore missing components of normal intestinal flora. Subjects will receive Fecal Microbiota Translantation via sigmoidoscopy.
16045469|NCT02557672|Drug|Prothrombin complex concentrate (Human)|PCC (Kcentra)
16045470|NCT02557672|Biological|Fresh frozen plasma (FFP)|FFP
16045471|NCT02557659|Device|Zenith Low Profile AAA Endovascular Graft|Treatment of patients with abdominal aortic, aorto-iliac, or iliac aneurysms having morphology suitable for endovascular repair
16045472|NCT02557646|Biological|Peginterferon alfa-2a|Participants received pegylated interferon subcutaneous injection in accordance with current guidelines and SPCs.P
16045473|NCT02557646|Drug|Ribavirin|Participants received ribavirin 200 mg film-coated tablet in accordance with current guidelines and SPCs.
16045474|NCT02557633|Biological|Grass MATA MPL 10200|
16045475|NCT02557633|Biological|Grass MATA MPL 18200|
16045476|NCT02557633|Biological|Placebo|
16045477|NCT02557620|Drug|semaglutide|Administered subcutaneously (s.c., under the skin)once daily or once weekly.
16045478|NCT02557620|Drug|placebo|Administered subcutaneously (s.c., under the skin)once daily or once weekly.
16045479|NCT02557607|Device|MRI|An analysis of the three sessions MRI performed systematically within the first 14 days of the start of symptoms revealing the HSA will be
16045480|NCT02557594|Drug|Viread 300mg|single dose administration after 10hr fasting
16045481|NCT02557594|Drug|DA-2802 319mg|single dose administration after 10hr fasting
16045482|NCT02557581|Other|No training|
16045483|NCT02557581|Other|Endurance training|
16045484|NCT02557581|Other|Resistance Training|
16045485|NCT02557581|Drug|Terbutaline|
16045486|NCT02557581|Drug|Clenbuterol|
16045487|NCT02557581|Drug|Placebo|
16045488|NCT02557568|Other|Staphylococcus aureus carriage|Staphylococcus aureus carriage is measured in the nose. Nasal samples were taken by the nursing staff of the ward using nylon flocked swab. Prior taking the sample, swabs were wetted using an additional tube containing a sponge impregnated with normal saline solution.
16045489|NCT02557555|Other|educational information|patients will receive pamphlet on labor analgesia options.
16045490|NCT02557542|Other|One Stop Vein Clinic|Same day diagnosis and treatment
16045491|NCT02557542|Device|Radiofrequency ablation|Venous ablation
16045492|NCT02557542|Device|Endovenous laser ablation|Venous ablation
16045493|NCT02557542|Drug|Foam sclerotherapy (Polidocanol or Sodium Tetradecyl Sulphate)|Venous ablation
16045494|NCT02557529|Behavioral|Progressive Resistance Training|12 weeks supervised resistance training program. Details of the program: 12 weeks, 3 sessions per week, 7 exercises in training machines (leg press, leg curl, hamstring curl, chest press, lateral pull down, sit-ups and back extensions). In general 2-3 sets of 8-15 repetitions will be performed following a progression plan starting with more repetitions at lower intensity progressing to fewer repetitions at higher intensity during the 12-week period (American College of Sports Medicine Position Stand)
16045495|NCT02557529|Behavioral|physical activity|Weekly diary of performed physical activity using the Physical Activity Score (PAS) during the 12-weeks intervention
16045496|NCT02557529|Behavioral|Diet diary|Weekly diet diary during the 12-weeks intervention
16045727|NCT02555930|Other|No Intervention|No intervention - observational only
16045497|NCT02557516|Drug|monalizumab|"During phase 1, patients received monalizumab, IV, at the dose of 1, 2 or 4mg/kg, as a single agent during 4 weeks and thereafter combined with ibrutinib 420 mg, orally, once daily, during 52 weeks.
~During phase 2, patients received monalizumab, IV, at the dose recommended upon completion of phase 1, combined with ibrutinib 420 mg orally, once daily, from the first cycle, during 52 weeks. In both parts of the trial, the first 4 administrations of monalizumab (from week 0 to week 6) occured every 2 weeks. From the 5th administration monalizumab was administered every 4 weeks."
16045498|NCT02557503|Drug|Oxaliplatin and fluorouracil|Oxaliplatin and fluorouracil by HAIC on with or without concomitant vascular invasion and extrahepatic metastases unresectable advanced primary liver cancer after TACE
16045499|NCT02557490|Drug|oxaliplatin and raltitrexed|"TACE methods: use of epirubicin 20-40mg emulsifier lipiodol embolization target vessel, with gelatin sponge particles or PVA particles or microspheres embolization supplement.
~Hepatic arterial chemotherapy: Bi embolization catheter in the hepatic artery or left hepatic artery branch within the right, chemotherapy, for the experimental group (A group): OXA 130mg / m2 artery 0-4 hours pumped Raltitrexed 3mg/m2 4-5 hours pumped into the arteries; the control group (group B)"
16045500|NCT02557477|Dietary Supplement|Omega 3/6 fatty acids|Three Omega 3/6 capsules twice daily
16045501|NCT02557477|Dietary Supplement|Placebo|Three placebo capsules twice daily
16045502|NCT02557464|Behavioral|An eye tracking experiment|Neuropsychological assessments and eye tracking during reading will be practice twice with an interval of 6 months
16045503|NCT02557464|Behavioral|A neuropsychological evaluation|Neuropsychological assessments and eye tracking during reading will be practice twice with an interval of 6 months
16045504|NCT02557451|Other|Surgery|
16045505|NCT02557451|Other|Intravitreal injections of gas|
16045506|NCT02557451|Procedure|injections of an antiangiogenic|
16045509|NCT02557425|Other|No intervention in PROTECT|
16045510|NCT02557412|Device|Continuous positive airway pressure|Treatment with nasal CPAP. Treatment begins with an empirical pressure of 8 cmH2O and in a period of three weeks, the pressure is adjusted by automatic titration with AutoSet II (ResMed) device.
16045511|NCT02557412|Behavioral|Intensive lifestyle intervention|Specific alimentary plan (carbohydrates: 40-45%; fats: 25-35% [saturated fats <7% monounsaturated fats up to 20% and polyunsaturated fats <10% ] and proteins: 15-20%) and recommendation to increase daily physical activity, setting a target walking 10,000 steps a day. The patients will be provided with a pedometer and will asked to fill out a form with the steps that they walked each day. At each visit, the distance walked will be reviewed and the target set will be remarked.
16045512|NCT02557412|Other|Conventional treatment|Hygiene and diet recommendations on sleep
16045513|NCT02557399|Drug|Duac® fixed dose combination gel|Duac® fixed dose combination gel containing clindamycin phosphate 1.2% and benzoyl peroxide 3%.
16045514|NCT02557399|Drug|ADA 0.1% gel|ADA 0.1% gel containing 0.1% of adapalene.
16045515|NCT02557399|Drug|CLDM 1% gel|CLDM 1% gel containing clindamycin phosphate 1.2% (1% as clindamycin).
16045516|NCT02557386|Drug|Levobupivacaine 5 mL|Levobupivacaine 0.25% 5 mL in adductor canal nerve block
16045517|NCT02557386|Drug|Levobupivacaine 10 mL|Levobupivacaine 0.25% 10 mL in adductor canal nerve block
16045518|NCT02557386|Drug|Levobupivacaine 15 mL|Levobupivacaine 0.25% 15 mL in adductor canal nerve block
16045519|NCT02557386|Drug|Levobupivacaine 20 mL|Levobupivacaine 0.25% 20 mL in adductor canal nerve block
16045520|NCT02557386|Drug|Levobupivacaine 25 mL|Levobupivacaine 0.25% 25 mL in adductor canal nerve block
16045521|NCT02557386|Drug|Levobupivacaine 30 mL|Levobupivacaine 0.25% 30 mL in adductor canal nerve block
16045522|NCT02557373|Dietary Supplement|Vitamin A|100,000 IU (oral supplement) on Day 1 of the intervention. No additional Vitamin A supplementation.
16045523|NCT02557373|Dietary Supplement|Rice Bran + Vitamin A|100,000 IU (oral supplement) on Day 1 of the intervention. No additional Vitamin A supplementation. Dietary rice bran consumed daily and amounts increase throughout the 3 month intervention (6 months of age: 1 g/day rice bran, 7 months: 2 g/day rice bran, 8 months: 3 g/day)
16045524|NCT02557360|Dietary Supplement|S-adenosyl-L-methionine|Patients will be treated with S-adenosyl-L-methionine, tablets 800 mg twice a day (daily dosage 1600 mg) for six months
16045525|NCT02557347|Behavioral|Aggressive fluid management|nursing education, dietary advice, extra hypertonic dialysis cycles
16045526|NCT02557334|Dietary Supplement|Low Dose Strawberry Powder|40 g composed of 13 g freeze dried strawberry powder + 27 g placebo powder
16045527|NCT02557334|Dietary Supplement|High Dose Strawberry Powder|40 g freeze dried strawberry powder
16045528|NCT02557334|Dietary Supplement|Placebo Powder|40 g color and taste matched placebo powder
16045529|NCT02557321|Drug|PV-10|PV-10 will be administered by intralesional injection every 3 weeks at Day 1 (Week 1), Week 4, Week 7, Week 10 and Week 13
16045530|NCT02557321|Drug|Pembrolizumab|Pembrolizumab will be administered intravenously every 3 weeks starting at Day 1 (Week 1)
16045531|NCT02557269|Drug|Xylometazoline - intranasal application|Applied as needed up to 5 consecutive days when prominent congestion
16045532|NCT02557269|Drug|Azelastine - intranasal application|Applied as needed when prominent symptom is rhinorrhea
16045533|NCT02557269|Drug|Mometasone furoate - intranasal application|Applied once daily (2 puffs) when no satisfactory therapeutic control from other intranasal treatment
16045534|NCT02557269|Drug|Hydroxyl-propyl-methyl cellulose powder - intranasal application|Applied intranasally immediately after every application other intranasal formulation
16045535|NCT02557269|Other|Placebo - Lactose powder|Applied intranasally immediately after every application other intranasal formulation
16045536|NCT02557269|Drug|Bilastine 20 mg|1 tablet per os - as needed
16045537|NCT02557269|Drug|Prednisolone 5 mg|Per os - if needed (only in case of broncial obstruction)
16045538|NCT02557217|Drug|NP202|Active
16045539|NCT02557217|Other|Placebo|Placebo
16045540|NCT02557204|Procedure|conventional technique|the nasogastric tube will be inserted gently through a selected nostril with the head being maintained in the neutral position.
16045541|NCT02557204|Procedure|head in the lateral position technique|the patient's head will be turned to the right lateral position. Nasogastric tube will be inserted through the right nostril without any maneuvers of the neck.
16045542|NCT02557204|Procedure|endotracheal tube assisted technique|Nasogastric tube will be inserted the trimmed 7.5 mm internal diameter endotracheal tube what cut proximal end with sterile scissors and endotracheal tube will be advanced blindly into the oral cavity to a depth of approximately 18 cm without laryngoscope together the nasogastric tube.
16045543|NCT02557204|Procedure|videolaryngoscope technique|Nasogastric tube was inserted transnasally and advanced into esophagus under direct vision.
16045544|NCT02557191|Other|Observational study|
16045545|NCT02557178|Behavioral|health coaching|Supportive coaching to encourage compliance with prescribed pulmonary rehabilitation.
16045546|NCT02557165|Procedure|Muscle biopsies|Muscle biopsies will allow acces to samples for observational studies. Vastus latetalis: needle biopsy (Bergstrom technique). Diaphragm: open biopsy performed by thoracic surgeon during lung surgery.
16045547|NCT02557152|Device|GentleWave System Treatment|
16045550|NCT02557126|Drug|URC102|
16045551|NCT02557126|Drug|Placebo|
16045552|NCT02557113|Procedure|Vertebroplasty|Fractured Osteoporotic Vertebral Body is Augmented with Injection of Bone Cement
16045553|NCT02557113|Procedure|Cavuplasty|Small Cavity is Created in Fractured Osteoporotic Vertebral Body Prior to Cement Injection
16045554|NCT02557100|Drug|Abatacept|
16045555|NCT02557100|Drug|Adalimumab|
16045556|NCT02557100|Drug|Methotrexate|
16045557|NCT02557087|Drug|Hyoscine|
16045558|NCT02557087|Drug|Pethidine|
16045559|NCT02557074|Drug|IL2|IL2 1.5MUI/d SC from day 1 to day 5 for the first course of treatment IL2 3MUI/d SC from day 1 to day 5 for the 3 following courses
16045560|NCT02557074|Drug|placebo|NaCl 9% serum SC from day 1 to day 5 for the four courses of treatment
16045561|NCT02557061|Procedure|Colorectal surgery (resection)|Colorectal surgery (resection) is done for patient with colorectal cancer
16045562|NCT02557061|Biological|Blood sampling|Pre-operative blood sampling is done for patient with colorectal cancer
16045563|NCT02557035|Drug|Palonosetron|
16045564|NCT02557035|Drug|Dexamethasone|
16045565|NCT02557022|Other|GI and/or GL|Randomized controlled trials of equal or more than 12 weeks duration looking at the GI and/or GL of diet as a whole and providing data on body weight
16045566|NCT02556996|Biological|ETEC/rCTB vaccine|Cocktail of five whole-cell, formalin-inactivated ETEC strains (total of 10^11 formalin-killed bacteria per dose) plus recombinant cholera toxin B-subunit (rCTB) (1 mg)
16045567|NCT02556996|Other|Placebo|Heat-killed, nonpathogenic E. coli K-12 bacteria (total of 10^11 heat-killed bacteria per dose)
16045568|NCT02556983|Radiation|CT|Contrast-enhanced CT images of the abdomen and pelvis will be obtained during the portal venous phase using a 256-channel CT system (Philips Healthcare, Cleveland, OH). The target median dose-length product (DLP) is 130 mGy·cm, which corresponded to an effective dose of 2 mSv with a conversion factor of 0.015 mSv·mGy-1·cm-1. The radiation output was automatically adjusted according to the individual patient's body size.
16045569|NCT02556970|Procedure|Single port VATS|Performing video-assisted thorascopic surgery through a single port
16045570|NCT02556970|Drug|Paracetamol|1g intraoperatively
16045571|NCT02556970|Drug|Diclofenac|75mg intraoperatively
16045572|NCT02556970|Device|Camera (5mm diameter 30 degree videothoracoscope)|
16045573|NCT02556970|Device|Forceps grasper|
16045574|NCT02556970|Drug|0.25% Levobupivicaine intercostal nerve block|Multi-level intercostal blocks will be placed subpleurally under thorascopic visualisation.
16045575|NCT02556957|Behavioral|HealthScouts|
16045576|NCT02556957|Other|Standard of Care|
16045577|NCT02556944|Device|Phacoemulsification with multifocal intraocular lens|Phacoemulsification and implantation of a multifocal intraocular lens (IOL) with two different add power (+2.75 diopters (D) or +3.25 D, respectively) in each eye of a patient, contralaterally. They're called mix and matched patients.
16045578|NCT02556931|Drug|Fludarabine|Days -6 through -2: 30 mg/m^2 IV daily
16045579|NCT02556931|Drug|Cyclophosphamide|Days -6 and -5: 14.5 mg/kg IV daily Days 3 and 4: 50 mg/kg IV daily
16045580|NCT02556931|Radiation|Total body irradiation|Day -1: 200 cGy in a single fraction
16045581|NCT02556931|Drug|Tacrolimus|Start on Day 5 through either Day 60 or Day 90 depending on cohort assignment. May be continued through Day 180 depending on GVHD status.
16045582|NCT02556931|Drug|Mycophenolate mofetil|Days 5 through 35: 15 mg/kg PO three times daily (max 3 g/day)
16045583|NCT02556918|Drug|Sitagliptin|Subjects will take one pill daily starting one day prior to surgery until discharge from the hospital. Sitagliptin will be dispensed orally at 100 mg/day for patients with a glomeruler filtration rate (GFR) greater than or equal to 50. Patients with a GFR between 30-49 will receive 50 mg/day.
16045584|NCT02556918|Drug|Placebo|One pill daily starting one day prior to surgery until discharge from the hospital.
16045585|NCT02556918|Drug|Regular Human Insulin|Continuous intravenous insulin given to intensive care unit (ICU) patients with a blood glucose (BG) greater than 180 mg/DL and will be started on Regular Human Insulin adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol.Intravenous insulin infusion will be continued until the patient is able to eat and/or is transferred to non-ICU service. In previous studies, average length of insulin infusion in patients with stress hyperglycemia was 16.9±19 hours and the amount of IV insulin requirement was 18.6±24.3 U/day.
16045586|NCT02556918|Drug|Insulin glargine|"Patients that required continuous insulin infusion (CII) at a rate >1U/h will be transitioned to basal insulin (glargine/detemir). Calculate total daily dose (TDD) of insulin from the average CII rate during the last four hours of infusion (example, if the average rate is 2 U/hr., the TDD is 48 U/day) Give 50% of calculated dose as basal (glargine/detemir) insulin every day. Basal insulin will be given approx. 4 hours before discontinuation of CII.
~The total daily insulin dose will be adjusted as follow:
~Fasting and pre-meal BG between 100-180 mg/dl without hypoglycemia the previous day: no change Fasting and pre-meal BG between >180-240 mg/dl: increase basal dose by 10% every day Fasting and pre-meal BG >241 mg/dl: increase basal dose by 20% every day Fasting and pre-meal BG <100 mg/dl: stop basal"
16045587|NCT02556918|Drug|Supplemental insulin (Insulin lispro)|"Insulin lispro will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol. At bedtime, half of supplemental sliding scale insulin starting at blood glucose (BG) greater than 240 mg/dL will be given. For the subjects receiving supplemental insulin lispro with BG levels greater than 180 mg/dL, then supplemental insulin scale is as follows:
~BG between 181-220 mg/dL; 2-4 units of insulin lispro
~BG between 221-260 mg/dL; 3-5 units of insulin lispro
~BG between 261-300 mg/dL; 4-6 units of insulin lispro
~BG between 301-350 mg/dL; 5-7 units of insulin lispro
~BG between 351-400 mg/dL; 6-8 units of insulin lispro
~BG greater than 400 mg/dL; 7-9 units of insulin lispro"
16045588|NCT02556918|Drug|Supplemental insulin (Insulin aspart)|"Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol. At bedtime, half of supplemental sliding scale insulin starting at blood glucose (BG) greater than 240 mg/dL will be given. For the subjects receiving supplemental insulin aspart with BG levels greater than 180 mg/dL, then supplemental insulin scale is as follows:
~BG between 181-220 mg/dL; 2-4 units of insulin aspart
~BG between 221-260 mg/dL; 3-5 units of insulin aspart
~BG between 261-300 mg/dL; 4-6 units of insulin aspart
~BG between 301-350 mg/dL; 5-7 units of insulin aspart
~BG between 351-400 mg/dL; 6-8 units of insulin aspart
~BG greater than 400 mg/dL; 7-9 units of insulin aspart"
16045589|NCT02556905|Drug|REVLIMID®|The recommended starting dose of REVLIMID® is 25mg/day with water orally administered as a single 25mg capsule on Days 1-21 of repeated 28-day cycles. Dose can be adjusted upon the clinical laboratory result.
16045590|NCT02556905|Drug|Dexamethasone|The recommended dose of dexamethasone is 40mg/day on Days 1-4, 9-12, and 17-20 of each 28-day cycle for the 4 cycle of therapy and then 40mg/day orally on Days 1-4 every 28 days.
16045591|NCT02556892|Drug|Ibrutinib|Participants will self-administer 420 milligram (mg) oral ibrutinib once daily continuously from Cycle 1 to Cycle 6 and thereafter every 28 days until treatment discontinuation.
16045592|NCT02556879|Biological|Donor specific antibodies|Additional samples for Donor specific antibodies at each visit
16045593|NCT02556879|Biological|Serum bank|Additional samples for serum bank at each visit if possible
16045594|NCT02556879|Biological|DNA bank|Additional sample for DNA bank at inclusion visit if possible
16045595|NCT02556879|Procedure|Liver biopsy|Liver biopsy at 12 and 24 months after retransplantation (depending the centers : procedure performed in routine or interventional procedure)
16045596|NCT02556879|Procedure|Liver ultrasounds and Fibroscan|Liver ultrasounds and Fibroscan at 12 and 24 months after retransplantation (depending the centers : procedure performed in routine or interventional procedure)
16045597|NCT02556866|Drug|rituximab|Prednisone treatment plus rituximab administered by slow intravenous infusion at 375 mg/m2 at D1, D8, D15 and D22.
16045598|NCT02556866|Drug|Prednisone|
16045599|NCT02556866|Drug|Placebo|
16045600|NCT02556853|Device|Determination of tube position by ultrasound.|After placement of the left sided double lumen endotracheal tube, ventilation of both lungs will be verified by ultrasound (Sonoscape S6®). The ultrasound probe will be placed between the 2nd and 3rd intercostal space at the level of the midclavicular line parallel to the line. The probe will be slightly moved or tilted until the pleural line is identified. If lung sliding is identified then the ventilation of the lung will be considered adequate. The same procedure will be repeated for each lung alone, after lung separation is applied. Verification of the ultrasound findings will be performed by bronchoscopy (Pentax®). The depth of the tube will be adjusted according to the bronchoscopy findings until correct positioning is established.
16045601|NCT02556853|Other|Determination of tube position by auscultation.|After placement of the left sided double lumen endotracheal tube, ventilation of both lungs will be verified by auscultation of the upper lung fields. The same procedure will be repeated for each lung alone, after lung separation is applied. Verification of the ultrasound findings will be performed by bronchoscopy (Pentax®). The depth of the tube will be adjusted according to the bronchoscopy findings until correct positioning is established.
16045602|NCT02556840|Other|insulin therapy|
16045603|NCT02556827|Other|Obtaining a blood sample|Total oxidant capacity (TOC), total antioxidant capacity (TAC), oxidative stress index (OSI), paraoxonase-1 (PON-1), aryl esterase (ARES), myeloperoxidase (MPO), tumor necrosis factor-alpha (TNF-α), interleukin-1beta (IL-1β), matrix metalloproteinase-1 (MMP-1) and matrix metalloproteinase-9 (MMP-9) levels in venous blood were measured.
16045604|NCT02556827|Device|Reflectance confocal microscopy|1mm2-sized 10 images were taken from right cheek and forehead; the number of demodex, follicle, the number of mite per follicle, the number of infested follicle and the number of mite per infested follicle were calculated with RCM. And photoaging severity were also assessed by using RCM.
16045605|NCT02556827|Device|Sebumeter|Sebum rate at forehead and right cheek were evaluated with sebumeter
16045606|NCT02556827|Device|Video dermoscopy|Dermoscopic photoaging scale were assessed by using video dermoscopy.
16045607|NCT02556814|Drug|Caffeic acid tablets|Oral administration of caffeic acid tablets 0.3g three times per day for 3 months
16045608|NCT02556814|Drug|Dexamethasone|Oral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later.
16045609|NCT02556814|Drug|placebo|Oral administration of placebo tablets 0.3g three times per day for 3 months
16045610|NCT02556801|Biological|SUBLIVAC FIX Phleum Prat.|sublingual daily administration
16045611|NCT02556788|Drug|CD5789 (trifarotene) 50µg/g Cream|CD5789 (Trifarotene) 50µg/g cream applied once daily during 12 weeks.
16045612|NCT02556788|Drug|Placebo Cream|Placebo cream applied once daily during 12 weeks.
16045613|NCT02556775|Biological|A licensed human normal immunoglobulin other than HYQVIA for IV or SC infusion or an alternative treatment|To be determined by the physician
16045614|NCT02556775|Biological|HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase]|Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase
16045615|NCT02556762|Radiation|Radiotherapy with simultaneous modulated accelerated boost|Radiotherapy: 66Gy/30F to the gross tumor and 50Gy/25 to subclinical diseases
16045616|NCT02556762|Radiation|Standard dose radiotherapy|Radiotherapy: 50Gy/25F to both gross tumor and subclinical disease
16045617|NCT02556762|Drug|PF|Chemotherapy: Cisplatin and 5fluorouracil
16045618|NCT02556749|Dietary Supplement|Cranberry Juice Beverage|16 ounces of 54% cranberry juice cocktail
16045774|NCT02555657|Drug|capecitabine|
16045775|NCT02555657|Drug|eribulin|
16045619|NCT02556749|Dietary Supplement|Placebo Beverage|Color, calorie, and taste matched beverage without cranberry bioactives
16045620|NCT02556736|Drug|RST-001|RST-001 is a gene therapeutic delivered by intravitreal injection
16045621|NCT02556723|Drug|Intravitreal injections of ziv-aflibercept|All subjects will receive intravitreal injections of ziv-aflibercept under sterile conditions at baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, and 20 weeks. No topical or systemic antibiotics will be prescribed (pre- injection or postinjection).
16045622|NCT02556710|Biological|AMPION™|4 mL Ampion Injection
16045623|NCT02556710|Biological|Saline|4 mL Saline Injection
16045624|NCT02556697|Device|Bronchoscopy with in vivo confocal endomicroscopy|A bronchoscopy with in vivo confocal endomicroscopy is done for patients with a suspicion of emphysema or for patients with a suspicion of scleroderma
16045625|NCT02556658|Device|General anesthesia managed by the Smartpilot® View|General anaesthesia managed by the Smartpilot® View device The intervention consists of administering hypnotics and opioids according to effect-site concentrations and interaction model provided by the Smartpilot® View software for the entire duration of general anaesthesia.
16045626|NCT02556658|Device|General anesthesia managed without the Smartpilot® View|General anaesthesia without using the Smartpilot® View device The anesthetic induction will be performed by propofol or sufentanil and atracurium. The maintenance of anesthesia will be directed by desflurane and sufentanil. The dosages of anesthetics are left to the discretion of the doctor and nurse anesthetists in charge of the patient in the operating room.
16045627|NCT02556645|Other|Web-PE Therapy|Ten 60-minute psychotherapy sessions over 8 weeks, focused on gradually confronting distressing trauma-related memories and reminders. Web-PE is an internet-based version of prolonged exposure (PE) for posttraumatic stress disorder (PTSD).
16045628|NCT02556645|Other|Therapist-Delivered Present-Centered Therapy|Ten 60-minute psychotherapy sessions over 8 weeks, focused on identifying and solving day-to-day problems as they are brought up by the participants. PCT is a manualized therapy that has been used as active control condition in several CBT studies. It provides a credible comparison therapy to control for nonspecific therapeutic factors so that observed effects of Web-PE can be attributed to its specific ingredients beyond the benefits of good therapy.
16045629|NCT02556632|Drug|Curcumin-based Gel|Applied topically
16045630|NCT02556632|Procedure|Dermatologic Complications Management|Apply HPR Plus topically
16045631|NCT02556632|Other|Laboratory Biomarker Analysis|Correlative studies
16045632|NCT02556632|Other|Placebo|Apply placebo gel topically
16045633|NCT02556632|Other|Questionnaire Administration|Ancillary studies
16045634|NCT02556619|Behavioral|Early Palliative Care/Symptom Control|"Establish palliative care goals
~Determination of Medical Power of Attorney
~Discuss/plan code status/advance directives
~Document palliative care goals
~Symptom Assessment and Control
~Pain-treatment with opioid and non-opioid medications
~Itching-H2 blockers, steroids
~Nutrition-appetite stimulated with Megace, review low sodium diet
~Ascites/edema- optimize ascites management with Lasix or Aldactone. In refractory cases intermittent paracentesis can be performed
~Nausea- treated with anti-emetics
~Jaundice and Body Image- counselling regarding symptoms
~End-of-Life Care
~Discuss religious preferences
~Assess for distress- ensure interaction with Cancer Resource Center
~Hospice- charity Hospice options for select patients."
16045635|NCT02556606|Drug|Ketamine|randomly assigned to a single 40 min infusion of either KET 0.1mg/Kg
16045636|NCT02556606|Drug|Ketamine|randomly assigned to a single 40 min infusion of either KET 0.25mg/Kg
16045637|NCT02556606|Drug|Ketamine|randomly assigned to a single 40 min infusion of either KET 0.50mg/Kg
16045638|NCT02556606|Drug|Midazolam|single 40 min infusion of MID 0.03mg/Kg
16045639|NCT02556593|Radiation|IMRT|Daily IMRT at 45 Gy in 15 fractions to brain metastases
16045640|NCT02556593|Radiation|WBRT|3DCRT at 30 Gy in 10 fractions to whole brain
16045641|NCT02556593|Drug|erlotinib|erlotinib 150mg daily
16045642|NCT02556580|Drug|Albumin 20%|Intervention: intravenious infusion Drug: albumin
16045643|NCT02556567|Other|Fitbit® Charge Heart Rate (HR) wristband|The Investigators will conduct a proof of concept and feasibility study to explore associations between asthma symptoms and sleep patterns and physical activity over an 8-week intervention period among 20 adolescent patients with persistent asthma.
16045644|NCT02556554|Device|Dexcom G4 or G5 Platinum CGM system|Intervention arm using the Dexcom G4 or G5 Platinum® CGM system during pregnancy
16045645|NCT02556554|Device|Dexcom G4 or G5 Platinum CGM system with Share|Treatment arm using the Dexcom G4 or G5 Platinum® CGM system with Share™
16045646|NCT02556541|Procedure|IV puncture guided by ultrasound|
16045647|NCT02556528|Behavioral|Health Coaching|
16045648|NCT02556515|Procedure|Interpositional arthroplasty (Burton-Pellegrini procedure)|Burton-Pellegrini procedure
16045649|NCT02556515|Procedure|Total joint replacement|Total joint replacement
16045650|NCT02556515|Device|Elektra prosthesis|Elektra prosthesis
16045651|NCT02556502|Device|18F-Florbetaben PET|
16045652|NCT02556476|Procedure|mechanical ventilation|ventilator support for the patients presenting with acute respiratory failure
16045653|NCT02556476|Procedure|neuromuscular blockade|paralysis of the skeletal muscles in order to optimize mechanical ventilation, especially during ARDS
16045654|NCT02556476|Procedure|renal replacement therapy|the procedures used to treat acute kidney injury
16045655|NCT02556476|Procedure|non-invasive ventilation|Procedure used for ventilation support in patients with congestive heart failure, pulmonary edema, COPD and some other conditions.
16045656|NCT02556463|Drug|MEDI9197|Subjects will receive MEDI9197 (every 4 weeks) as monotherapy (or MEDI9197 every 8 weeks + durvalumab every 4 weeks)(PA6)
16045657|NCT02556463|Biological|durvalumab|Subjects will receive durvalumab every 4 weeks
16045658|NCT02556450|Drug|Spironolacton|Administration of Spironolacton 25 mg per day
16045659|NCT02556437|Drug|HyQvia|Human immunoglobulin 10% with recombinant hyaluronidase for subcutaneous injection
16045660|NCT02556437|Drug|Subcuvia|Human immunoglobulin 16% for subcutaneous injection
16045661|NCT02556424|Drug|Dexamethasone|Intravitreal implant at D0
16045662|NCT02556424|Drug|Triamcinolone|Subconjunctival injection at 4 mm from the limbus at 6 o'clock
16045663|NCT02556411|Drug|LNG-IUS 13,5 mg Levonorgestrel|LNG-IUS
16045776|NCT02555657|Drug|gemcitabine|
16045777|NCT02555657|Drug|vinorelbine|
16045664|NCT02556411|Drug|Levonorgestrel 0,10 mg+ ethinylestradiol 0,02 mg|Levonorgestrel 0,10 mg+ethinylestradiol 0,02 mg oral contraceptive pill in continuous regime
16045665|NCT02556398|Behavioral|Sugar Sleuth|"Educational module and use of smart phone app (Sugar Sleuth)"
16045666|NCT02556385|Device|High frequency rTMS|Most activated area from fNIRS findings: Perileisional Broca's area, High frequency rTMS (10Hz), Number of total stimuli: 800, Location: perilesional Broca's area, Intensity: 100% of resting motor threshold, Coil orientation: tangential to scalp, in combination with speech therapy(35-40min) after each rTMS session, Daily 10 treatment session
16045667|NCT02556385|Device|Low frequency rTMS|Most activated area from fNIRS findings: Contralesional homologs of Broca's area, Low frequency rTMS (1Hz), Number of total stimuli: 1200, Location: Contralesional homologs of Broca's area (Pars triangularis), Intensity: 90% of resting motor threshold, Coil orientation: tangential to scalp, in combination with speech therapy(35-40min) after each rTMS session, Daily 10 treatment session
16045668|NCT02556372|Drug|JKB-122|Orally administered capsules of JKB-122 which will be taken once daily with dose escalation from 5mg up to 40mg depending on the monthly response.
16045669|NCT02556346|Drug|MT-3724|Intravenous dosing M-W-F X 2 weeks; MT-3724 infusion over 2 hours on each dosing day over 4 week initial cycle and then 3 week repeat cycles for up to 5 total cycles.
16045670|NCT02556346|Drug|MT-3724|Intravenous dosing M-W-F X 2 weeks; MT-3724 infusion over 2 hours on each dosing day over 4 week initial cycle and then 3 week repeat cycles for up to 5 total cycles.
16045671|NCT02556346|Drug|MT-3724|Intravenous dosing M-W-F X 2 weeks; MT-3724 infusion over 2 hours on each dosing day over 4 week initial cycle and then 3 week repeat cycles for up to 5 total cycles.
16045672|NCT02556346|Drug|MT-3724|Intravenous dosing M-W-F X 2 weeks; MT-3724 infusion over 2 hours on each dosing day over 4 week initial cycle and then 3 week repeat cycles for up to 5 total cycles.
16045673|NCT02556346|Drug|MT-3724|Intravenous dosing M-W-F X 2 weeks; MT-3724 infusion over 2 hours on each dosing day over 4 week initial cycle and then 3 week repeat cycles for up to 5 total cycles.
16045674|NCT02556333|Drug|FTC/TAF|Tenofovir alafenamide (TAF) is an investigational oral prodrug of tenofovir. This trial will explore the safety and efficacy of TAF in a fixed combination with emtricitabine (FTC) (F/TAF, Gilead Sciences Inc.) as part of a salvage antiretroviral regimen for HIV-1-infected adults and adolescents (greater than or equal to 14 years) who experienced virologic failure.
16045675|NCT02556320|Drug|anti-epileptic drug|Patient who initiate anti-epileptic drug (sodium valproate, divalproate sodium, valpromide, lamotrigine, carbamazepine, oxcarbazepine, eslicarbazepine acetate)
16045676|NCT02556320|Biological|Blood sampling|Blood sampling is done for Patient who initiate anti-epileptic drug (sodium valproate, divalproate sodium, valpromide, lamotrigine, carbamazepine, oxcarbazepine, eslicarbazepine acetate)
16045677|NCT02556307|Drug|Peginterferon alfa-2a|Peginterferon alfa-2a according to the standard practice in line with current summaries \nof product characteristics (SPCs)/local labeling.
16045678|NCT02556307|Drug|Ribavirin|Ribavirin according to the standard practice in line with current summaries \nof product characteristics (SPCs)/local labeling.
16045679|NCT02556294|Behavioral|Self-acceptance based intervention|The intervention will consist of HIV/STI counseling and testing as well as individual counseling sessions and group sessions. The primary focus of the group sessions are to help foster self-acceptance by the support from the group, as well as learn skills to reduce distress and HIV risk. The primary purpose of the individual sessions is to help develop and implement an individualized plan for HIV risk reduction, and, as needed and available, linkage to other services.
16045680|NCT02556294|Behavioral|HIV/STI counseling and testing|The counseling component is standard of care in India and will focus on HIV/STI risk and how to minimize risk. This is followed by biological testing for HIV and STIs.
16045681|NCT02556281|Biological|Blood sampling|Blood sampling is done for patient with colorectal cancer
16045682|NCT02556268|Drug|Riociguat (Adempas, BAY 63-2521)|0.5 mg, Oral (fasted conditions), 1 single dose
16045683|NCT02556268|Drug|ATRIPLA|600 mg efavirenz, 200 mg emtricitabine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily
16045684|NCT02556268|Drug|COMPLERA|200 mg emtricitabine, 25 mg rilpivirine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily
16045685|NCT02556268|Drug|STRIBILD|150 mg elvitegravir, 150 mg cobicistat, 200 mg emtricitabine, and 300 mg tenofovir disoproxil fumarate, i.e. 1 tablet, once daily
16045686|NCT02556268|Drug|TRIUMEQ|600 mg abacavir, 50 mg dolutegravir, and 300 mg lamivudine, i.e. 1 tablet, once daily
16045687|NCT02556268|Drug|Antiretroviral protease inhibitor|Any approved antiretroviral protease inhibitor such as atazanavir, darunavir, indinavir, ritonavir, and saquinavir ; consistent with the most recent prescribing information documents
16045688|NCT02556255|Device|B-Laser™ Atherectomy Catheter|Laser atherectomy catheter based on 355 nm
16045689|NCT02556242|Other|Targeted indoor residual spraying|IRS is carried out in neighbourhoods of cases
16045690|NCT02556242|Other|Generalised Indoor residual spraying|IRS is carried out as normally practiced
16045691|NCT02556229|Drug|Aflibercept|The patients are followed on a monthly basis until 52 weeks. Intravitreal injections of aflibercept at a dosage of 2 mg are initiated at inclusion (mandatory injection) with reinjection every 4 weeks only in case of CNV activity (PRN regimen) until 52 weeks.Therefore, each patient receives between 1 and 13 injections in the whole study.
16045692|NCT02556203|Drug|Rivaroxaban (Xarelto, BAY59-7939)|10mg OD (once-daily)
16045693|NCT02556203|Drug|Acetylsalicylic Acid (ASA)|75-100mg OD
16045694|NCT02556203|Drug|Clopidogrel|75mg OD
16045695|NCT02556203|Drug|Rivaroxaban (Xarelto, BAY59-7939)|In case of NOAF, 20/15 mg OD (once-daily)
16045696|NCT02556203|Drug|Vitamin K antagonist (VKA)|In case of NOAF, Open-label VKA therapy to target international normalized ratio (INR) 2-3, according to guidelines
16045697|NCT02556177|Procedure|MRI|MRI scanning
16045698|NCT02556164|Procedure|Electroacupuncture|Acupuncture is an alternative medicine methodology that treats patient by various techniques including inserting small, thin needles at specific points of body. Electroacupuncture (EA), like the name implies, combines classical acupuncture and low electric current running through the needles, which are often used to enhance a treatment.
16045726|NCT02555943|Drug|Tenofovir disoproxil|VIREAD is indicated for the treatment of chronic hepatitis B in adults and pediatric patients 12 years of age and older.
16045699|NCT02556164|Other|Body-worn sensor technology|Three-dimensional acceleration and angular velocity of shanks, thighs and the trunk were measured using wearable sensors each included a triaxial accelerometer and a triaxial gyroscope (LEGSys™ and BalanSens™ - BioSensics, Boston, MA)
16045700|NCT02556151|Procedure|Repetitive lumbosacral magnetic stimulation (rTLSMS)|Patients randomized to Six sessions of weekly therapy with either 1 HZ or 5 Hz or 15 Hz magnetic stimulations of the lumbar and sacral regions.
16045701|NCT02556138|Device|ORBERA Intragastric Balloon|The ORBERA Intragastric Balloon will be placed in the stomach endoscopically through a catheter under conscious sedation. The procedure takes about 20 minutes to complete. The balloon will stay in place for 6 months and then it will be removed endoscopically.
16045702|NCT02556125|Device|Diaphragm pacing|Intramuscular diaphragm implantation is achieved by a laparoscopic approach whereby phrenic motor points on the diaphragm are mapped to optimize electrode placement. The electrodes are threaded into the diaphragm muscle and wire leads are externalized and attached to a stimulation controller.
16045703|NCT02556112|Behavioral|Group Lifestyle Balance|The content of the GLB program consists of educating participants about the association between high calorie and fat intake with excessive weight, how to determine the fat and calorie content of foods they eat, and how to make changes in their diet to reduce the fat and calorie content. Participants are also given information about increasing activity in their daily routines. In addition, they are given information about negative behaviors that lead to overeating and decreased activity and are taught ways to develop positive behaviors to facilitate weight loss and increased activity. GLB instructors function as lifestyle coaches for class participants. They provide individual feedback and encouragement on documented eating and activity habits. The instructors make themselves available to be contacted by participants outside of class to address participant concerns and issues as needed
16045704|NCT02556112|Behavioral|Better Body Better Life|The BBBL program is an Air Force weight management program.). It was created based on the Adult Learning Model and consists of 5 independent modules that are taught in-person to groups of up to 15-20 individuals. Each module is done in a classroom and is 2 hours long. One module per week is offered. Individuals can attend the modules in any order but they are required to complete a pre-survey and 3-day food record prior to attending their first class
16045705|NCT02556112|Behavioral|Fitness Improvement Program|The FIP is a standardized course that can be accessed on-line through the Advanced Distributed Learning Service (ADLS) and takes approximately 90 minutes to view all of the course material. The on-line FIP can be done all in one sitting or in segments. There is no restriction on the frequency with which the FIP is viewed however, because it is accessed through ADLS, it may be difficult to view at a non-military computer. The FIP consists of an introduction, three core components (nutrition, physical training, and spiritual well-being), and a summary. Each section has a short video presentation. The core components have short quizzes at the end to assess knowledge and the training asks participants to set goals. Participants are then responsible for using the information for their own self-directed program.
16045706|NCT02556099|Drug|Hydroxyurea|drug to be administered
16045707|NCT02556086|Drug|Daclatasvir|
16045708|NCT02556086|Drug|Sofosbuvir|
16045709|NCT02556073|Other|Smartphone action|Smartphone applications (Apps) can provides a platform not only to share health information at the point-of-living, including health assessments, personalized health plans, but also to remind the patients' medication adherence regularly. With the application of modern smartphone-based asthma self management deserves further investigation to improve asthma control.
16045710|NCT02556073|Drug|usual care|fluticasone/salmeterol 125/25 ug/puff, 2 puff bid plus salmeterol as-needed
16045711|NCT02556060|Drug|Lamotrigine|Starting from 25 mg/day in the first week, then titrated up to 200 mg/day for 12 weeks
16045712|NCT02556060|Drug|Placebo|Same dosing schedule as study drug
16045713|NCT02556047|Device|Star Intradermal Safety Device|Star Intradermal Safety Device 1.2mm needle length, Star Intradermal Safety Device 1.5mm needle length, Mantoux technique by N&S
16045714|NCT02556034|Other|Disease evaluation.|Patients will complete a self-evaluation of 28 joint counts for swelling and tenderness and assess their disease activity on a Visual Analog Scale. A 28 joint count and VAS will then be assessed by a nurse and by a rheumatologist. The same rheumatologist will examine all patients and two nurses will each randomly assess half the total enrolled patients. The nurse will be blinded to the patient's joint count and VAS, and similarly, the rheumatologist will be blinded to both the patient and nurse's assessments.
16045715|NCT02556021|Drug|CJ-12420 50mg|CJ-12420 50mg, tablet, once daily, oral administration for up to 4 weeks
16045716|NCT02556021|Drug|CJ-12420 100mg|CJ-12420 100mg, tablet, once daily, oral administration for up to 4 weeks
16045717|NCT02556021|Drug|Placebo|Placebo, tablet, once daily, oral administration for up to 4 weeks
16045718|NCT02556008|Drug|cannabidiol (CBD)|Treatment will begin with 2 mg/kg/day given in two divided doses. The dose will be increased by 3 mg/kg/day after seven days and then by 5 mg/kg/day every seven days up to a maximum dose of 25 mg/kg/day given.
16045719|NCT02555995|Device|OCT scan (as yet unnamed)|OCT scan (as yet unnamed) of the eye with investigational device; newly developed sparse OCT retina scanner by Artorg Center Bern and Berner Fachhochschule Biel
16045720|NCT02555982|Drug|BOTOX ® 200 Unités|"Patients eligible for inclusion will be randomized to one of the two groups:
~Experimental group: 60 patients will receive 2 injections of Btx A (BOTOX - Allergan), one on D0 and one at 12W (into each splenius capitis).
~Control group: 60 patients will receive 2 injections of placebo, one on D0 and one at 12W (into each splenius capitis)."
16045721|NCT02555982|Drug|Placebo|Control group: 60 patients will receive 2 injections of placebo, one on D0 and one at 12W (into each splenius capitis).
16045722|NCT02555943|Drug|Ledipasvir/Sofosbuvir|Oral direct anti-HCV agent. Ledipasvir/Sofosbuvir(LDV/SOF) 400mg/90mg fixed-dose combination(FDC) tablet, administered orally once daily.
16045723|NCT02555943|Drug|Sofosbuvir and Daclatasvir|TWO oral direct anti-HCV agent: Sofosbuvir(SOF), 400mg tablet administered orally once daily. Daclatavir(DCV), 60mg tablet administered orally once daily.
16045724|NCT02555943|Drug|Ombitasvir, Paritaprevir, Ritonavir, Dasabuvir|VIEKIRA PAK includes ombitasvir, a hepatitis C virus NS5A inhibitor, paritaprevir, a hepatitis C virus NS3/4A protease inhibitor, ritonavir, a CYP3A inhibitor and dasabuvir, a hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor.
16045725|NCT02555943|Drug|Entecavir|Nucleoside-inhibitor-treatment-naïve with compensated liver disease (greater than or equal to 16 years old): 0.5 mg once daily.
16045728|NCT02555917|Procedure|anterior cruciate ligament reconstruction|Twenty patients planed to undergo anterior cruciate ligament reconstruction by preserving remnant and other twenty patients undergo anterior cruciate ligament reconstruction by preserving remnant.
16045729|NCT02555878|Drug|Rivaroxaban|Rivaroxaban 10 milligram (mg) tablet will be administered orally once daily for 180 days.
16045730|NCT02555878|Drug|Placebo|Placebo tablet will be administered orally once daily for 180 days.
16045731|NCT02555852|Drug|esomeprazole|Exposure to esomeprazole (ATC A02BC05, B01AC56, M01AE52, A02BD06) will be defined as a prescription for esomeprazole on the same day as a ≥ 30 day NSAID prescription.
16045732|NCT02555852|Drug|omeprazole|Exposure to omeprazole (ATC A02BC01, A02BD01) will be defined as a prescription for omeprazole on the same day as a ≥ 30 day NSAID prescription.
16045733|NCT02555852|Drug|pantoprazole|Exposure to pantoprazole (ATC A02BC02, A02BD04) will be defined as a prescription for pantoprazole on the same day as a ≥ 30 day NSAID prescription.
16045734|NCT02555852|Drug|lansoprazole|Exposure to lansoprazole (ATC A02BC03, A02BD07, A02BD03, A02BD02) will be defined as a prescription for lansoprazole on the same day as a ≥ 30 day NSAID prescription.
16045735|NCT02555852|Drug|rabeprazole|Exposure to rabeprazole (ATC A02BC04) will be defined as a prescription for rabeprazole on the same day as a ≥ 30 day NSAID prescription.
16045736|NCT02555852|Drug|cimetidine|Exposure to cimetidine (ATC A02BA01) will be defined as a prescription for cimetidine on the same day as a ≥ 30 day NSAID prescription.
16045737|NCT02555852|Drug|ranitidine|Exposure to ranitidine (A02BA02) will be defined as a prescription for ranitidine on the same day as a ≥ 30 day NSAID prescription.
16045738|NCT02555852|Drug|famotidine|Exposure to famotidine (A02BA03) will be defined as a prescription for famotidine on the same day as a ≥30 day NSAID prescription.
16045739|NCT02555852|Drug|nizatidine|Exposure to nizatidine (A02BA04) will be defined as a prescription for nizatidine on the same day as a ≥ 30 day NSAID prescription.
16045740|NCT02555852|Drug|niperotidine|Exposure to niperotidine (A02BA05) will be defined as a prescription for niperotidine on the same day as a ≥ 30 day NSAID prescription.
16045741|NCT02555852|Drug|roxatidine|Exposure to roxatidine (A02BA06) will be defined as a prescription for roxatidine on the same day as a ≥ 30 day NSAID prescription.
16045742|NCT02555852|Drug|ranitidine bismuth citrate|Exposure to ranitidine bismuth citrate (A02BA07) will be defined as a prescription for ranitidine bismuth citrate on the same day as a ≥ 30 day NSAID prescription.
16045743|NCT02555852|Drug|lafutidine|Exposure to lafutidine (A02BA08) will be defined as a prescription for lafutidine on the same day as a ≥ 30 day NSAID prescription.
16045744|NCT02555852|Drug|cimetidine combinations|Exposure to cimetidine combinations (A02BA51) will be defined as a prescription for cimetidine combinations on the same day as a ≥ 30 day NSAID prescription.
16045745|NCT02555852|Drug|famotidine combinations|Exposure to famotidine combinations (A02BA53) will be defined as a prescription for famotidine combinations on the same day as a ≥ 30 day NSAID prescription.
16045746|NCT02555839|Drug|Pomalidomide|4mg capsule on d1 through 21 of a 28 day cycle
16045747|NCT02555839|Drug|Dexamethasone|40 mg (≤75 years) or 20mg (>75 years) oral on d1, 8, 15, 22 of a 28 day cycle
16045748|NCT02555839|Drug|Pomalidomide|4mg capsule on d1 through 14 of a 21 day cycle
16045749|NCT02555839|Drug|Dexamethasone|cycle 1-8: 20mg PO (≤75 years) or 10mg (>75years) on Days 1, 2, 4, 5, 8, 9, 11, 12 of a 21 day cycle; from cycle 9 onwards: Dexamethasone 20mg PO (≤75 years) or 10mg (>75years) on Days 1, 2, 8, 9 of a 21 day cycle
16045750|NCT02555839|Drug|Bortezomib|cycle 1-8: Bortezomib (1,3mg/m2) s.c. on day 1, 4, 8, 11 of a 21 day cycle; from cycle 9 onwards: Bortezomib (1,3mg/m2) s.c. on day 1 and 8 of a 21 day cycle,
16045751|NCT02555813|Drug|Abraxane|Abraxane By IV infusion on Days 1, 8, 15 and 28 until progression or toxicity
16045752|NCT02555813|Drug|Gemcitabine|Gemcitabine 1000mg IV infusion on Days 1, 8, 15 and 28 until disease progression or toxicity
16045753|NCT02555800|Drug|Bevacizumab|Patients will receive 3 intralesional injections of bevacizumab (Avastin, Genentech, San Francisco, California) every 3 to 6 weeks in a submucosal plane after surgical debulking. 12.5 mg of bevacizumab diluted in 3mL of 9% isotonic sodium chloride solution will be injected intralesionally using a 25 gauge.
16045754|NCT02555800|Drug|Cidofovir|Patients will receive 3 intralesional injections of cidofovir every 3 to 6 weeks a submucosal plane after surgical debulking. 3.5 mL of cidofovir diluted to a concentration of 5 mg/mL in a 9% isotonic sodium chloride solution will be injected intralesionally using a 25 gauge.
16045755|NCT02555800|Other|Placebo|Saline solution
16045756|NCT02555787|Drug|Tacrolimus|oral
16045757|NCT02555774|Behavioral|cognitive training|cognitive training is held 2 times a week for 3 months, 90 minutes per 1 session. It includes cognitive exercise of multiple cognitive domains such as memory, attention, calculation, executive function and visuospatial function.
16045758|NCT02555774|Behavioral|lifestyle modification|education about lifestyle modification is done by investigators at the first day of the trial and the investigators conduct weekly phone call to participants to educate the lifestyle modifications
16045759|NCT02555761|Drug|Alcaftadine Ophthalmic Solution 0.25%|Alcaftadine Ophthalmic Solution 0.25% (Lastacaft®) as prescribed as standard of care in clinical practice.
16045760|NCT02555748|Drug|Pazopanib|
16045761|NCT02555748|Drug|Sunitinib|
16045762|NCT02555735|Drug|Standard of care chemotherapy|
16045763|NCT02555722|Device|fanfilcon A (test)|silicone hydrogel lens
16045764|NCT02555722|Device|enfilcon A (control)|silicone hydrogel lens
16045765|NCT02555709|Drug|VTP-43742|VTP-43742 administered as an oral capsule once daily
16045766|NCT02555709|Drug|Placebo 1|Placebo 1 matching VTP-43742 administered as an oral capsule once daily
16045767|NCT02555709|Drug|Placebo 2|Placebo 2 matching VTP-43742 administered as an oral capsule once daily
16045768|NCT02555696|Drug|nab-paclitaxel|nab-paclitaxel by IV infusion every 3 weeks until progression or toxicity
16045769|NCT02555683|Drug|QAW039|QAW039 150 mg once daily
16045770|NCT02555683|Drug|QAW039|QAW039 450 mg once daily
16045771|NCT02555683|Drug|Placebo|Placebo once daily
16045772|NCT02555670|Other|BIA|Bioelectrical impedance analysis was performed within 4 days after a CT-scan was made
16045773|NCT02555657|Biological|pembrolizumab|
16045778|NCT02555644|Drug|Prexasertib|Administered IV
16045779|NCT02555644|Drug|Cisplatin|Administered IV
16045780|NCT02555644|Drug|Cetuximab|Administered IV
16045781|NCT02555644|Radiation|Intensity Modulated Radiation Therapy|
16045782|NCT02555631|Behavioral|lifestyle|In this pilot study, each subject will receive the lifestyle intervention of the diabetes prevention program, a modified program for men from disadvantaged neighborhoods--a 16 weekly sessions of 1 hour each session
16045783|NCT02555618|Biological|TAK-850|TAK-850 subcutaneous injection
16045784|NCT02555618|Biological|Influenza HA vaccine|Influenza HA vaccine subcutaneous injection
16045785|NCT02555605|Drug|Dexmedetomidine|Children up to the age of 16 years requiring MRI under deep sedation with at least 3 characteristics of respiratory morbidities were identified as having increased risk for adverse respiratory events. Dexmedetomidine was administered as a first bolus of 1 mcg•kg-1 over 10 min, followed by a continuous infusion at 1.0 mcg•kg-1•h-1. Sedation level was assessed by Ramsay Sedation Scale and it was initially recorded at 1-min interval. If the child failed to achieve a minimum RSS of 5, this bolus was repeated once again and the continuous infusion was subsequently increased to 2 mcg•kg-1•h-1. In addition, propofol 0.5 mg.kg-1 iv. was allowed to be administered, in patients still exhibiting movement that could interfere with image acquisition.
16045786|NCT02555592|Procedure|Primary surgical resection with sequential adjuvant therapy|First, surgery resection of the affected lung with mediastinal lymph node dissection, including sub- and para-aortic lymph node, will be performed. If malignant tumor involvement only in the sub- or para-aortic lymph nodes is identified, adjuvant chemotherapy will be initiated within 8 weeks after surgery. After completion of adjuvant chemotherapy, post-operative radiotherapy will be initiated within 2~4 weeks after adjuvant chemotherapy.
16045787|NCT02555579|Behavioral|Dietary Protein Counting and Free Fruits and Vegetables|Subjects will be educated on new simplified diet approach and phenylalanine levels will be monitored for 1 year, and will be compared to 12 months prior to study enrollment
16045788|NCT02555566|Procedure|Blood sampling|Blood sampling is done for Kidney transplant recipients for evaluation of the polymorphisms and EETs dosage
16045789|NCT02555566|Procedure|flow-mediated distal stimulation of the forearm radial artery by cutaneous heating|Flow-mediated distal stimulation of the forearm radial artery by cutaneous heating for Kidney transplant recipients
16045790|NCT02555553|Behavioral|CBT-GSH with Noom Monitor|This intervention is cognitive behavioral treatment with a smartphone application
16045791|NCT02555540|Biological|Boostrix|Randomised assignment
16045792|NCT02555540|Biological|Placebo (Saline)|Randomised assignment
16045793|NCT02555501|Other|PDT + Low level laser|"Two days before the laser treatment, the side of the oral cavity chosen for the experimental treatment was pigmented with aqueous solution of 0.005% methylene blue. A ball of sterile cotton was soaked in the dye solution and placed in the center of the lesion. Photosensitizer remained in the place for 5 minutes (pre-irradiation period). Then, to activate the dye, the lesion was irradiated with red light (InGaAlP / phosphide and Indium, Gallium and potassium).
~From the 3rd to the 10th day was carried out only laser therapy. For laser therapy was first used infrared emitter laser unit with active medium AsGaAl (Gallium Arsenide and Aluminium). Then, we used the red emitter, whose active medium was the InGaAlP (phosphide and Indium, Gallium and Potassium)."
16045794|NCT02555501|Radiation|Low level laser|Two days before the laser treatment, the lesion of the side of the oral cavity chosen for the control treatment was treated with ball of sterile cotton soaked in distilled water and the laser unit placed on the lesion without activation of the light. From the 3rd to the 10th day was carried out laser therapy. For laser therapy was first used infrared emitter laser unit with active medium AsGaAl (Gallium Arsenide and Aluminium). Then, we used the red emitter, whose active medium was the InGaAlP (phosphide and Indium, Gallium and Potassium).
16045795|NCT02555488|Device|diode laser|MB and diode
16045796|NCT02555488|Device|diode laser|diode laser
16045797|NCT02555488|Drug|Methylene blue|Methylene blue and diode laser was used
16045798|NCT02555475|Other|community based hepatitis C care and treatment|
16045799|NCT02555462|Device|Real-Ear Measurement system integrated in hearing aid fitting software|The subjects individual response of the ear canal gets measured with the help of a probe tube and a following hearing aid fitting.
16045800|NCT02555449|Drug|[¹⁴C]-LY3202626|Administered as solution by mouth
16045801|NCT02555423|Drug|Local anaesthetic - chirocaine|
16045802|NCT02555410|Device|Brain Sentinel Seizure Detection and Warning System|A sEMG based automated seizure detection and warning system worn on the biceps
16045803|NCT02555397|Biological|Ad5-yCD/mutTKSR39rep-hIL12|Single intraprostatic injection of Ad5-yCD/mutTKSR39rep-hIL12 on day 1
16045804|NCT02555384|Other|crowded drawing task|Marking inverted signs on a sheet where symbols are presented close to one another
16045805|NCT02555384|Other|uncrowded drawing task|Marking inverted signs on a sheet where there is a larger distance between symbols
16045806|NCT02555371|Biological|Mepolizumab 100mg|Mepolizumab is a fully humanised Immunoglobulin (IgG) antibody (IgG1, kappa) with human heavy and light chain frameworks. Mepolizumab will be provided as a lyophilised cake in sterile vials for individual use.
16045807|NCT02555371|Drug|Placebo|The placebo will be 0.9% sodium chloride solution and will be provided by the study site.
16045808|NCT02555358|Drug|docetaxel,0xaliplatin,capecitabine|docetaxel 60mg/m2， ivgtt，2h，d1;capecitabine 1000mg/m2 po bid d1-14; oxaliplatin 130mg/m2， ivgtt，2h，d1;q21d
16045809|NCT02555358|Drug|oxaliplatin,capecitabine|oxaliplatin 130mg/m2， ivgtt，2h，d1;capecitabine 1000mg/m2 po bid d1-14;q21d
16045810|NCT02555332|Other|75g oral glucose tolerance test (OGTT)|All these women underwent the 75g oral glucose tolerance test (OGTT) at 24-28 weeks of gestation.
16045811|NCT02555319|Device|Transcatheter Pulmonary Valve (TPV)|Transcatheter Pulmonary Valve Replacement
16045812|NCT02555306|Drug|0.5 mg of DE-122|DE-122 Injectable Solution
16045813|NCT02555306|Drug|1.0 mg of DE-122|DE-122 Injectable Solution
16045814|NCT02555306|Drug|2.0 mg of DE-122|DE-122 Injectable Solution
16045815|NCT02555306|Drug|4.0 mg of DE-122|DE-122 Injectable Solution
16045816|NCT02555293|Drug|XIFAXAN® (Rifaximin)|
16045817|NCT02555280|Device|coflex® Interlaminar Technology|Decompression plus coflex® Interlaminar Technology
16045818|NCT02555280|Procedure|Decompression|Decompression alone
16045819|NCT02555254|Procedure|Low Speed of Rewarming|Speed of rewarming will be at 0.25°C/h with specific temperature controlled external device
16045820|NCT02555254|Procedure|High Speed of Rewarming|Speed of rewarming will be at 0.50°C/h with specific temperature controlled external device
16045821|NCT02555241|Behavioral|Mand Training|The mand training component of treatment will consist of behavioral principles designed to increase the participant's Mean Length of Utterances (MLU) when manding.
16045822|NCT02555241|Behavioral|Matrix|The matrix training component of treatment will consist of behavioral principles designed to teach labeling of noun-verb and color-shape combinations using matrix training.
16045823|NCT02555241|Behavioral|Stimulus Equivalence Training|The stimulus equivalence training component of treatment is designed to examine the emergence of untrained skills following the training of relational skills.
16045824|NCT02555228|Drug|Simethicone|100mg of liquid simethicone is put into 5mls of water and given at least 30 minutes before the gastroscopy.
16045825|NCT02555228|Other|Water|5mls of water is given at least 30 minutes before the gastroscopy.
16045826|NCT02555215|Drug|dimethyl fumarate|administered orally
16045827|NCT02555189|Drug|Enzalutamide|Given PO
16045828|NCT02555189|Drug|Ribociclib|Given PO
16045829|NCT02555176|Dietary Supplement|Dietary intervention|Follow a low-carbohydrate diet
16045830|NCT02555163|Device|HoLERBT|Using holmium laser, the tumour will be removed as one piece from its base working underneath the muscle layer
16045831|NCT02555163|Device|cTURBT|using the conventional electrocautery device with the cutting hot loop the tumor will be removed in pieces
16045832|NCT02555150|Drug|PRC-063|Oral extended-release capsule
16045833|NCT02555150|Drug|lisdexamfetamine dimesylate|Oral capsule
16045834|NCT02555150|Drug|Placebo|Oral placebo capsule
16045835|NCT02555137|Other|'prediction score' and 'rule-out criteria'|The combination of the 'prediction score' and the 'rule-out criteria' constitutes an accurate follow-up after PE aimed at diagnosing CTEPH in early stages.
16045836|NCT02555124|Drug|JNJ-42847922, 5 mg|Participants will receive single oral dose of 5 milligram (mg) of JNJ-42847922 on Day 1, fasted condition.
16045837|NCT02555124|Drug|JNJ-42847922, 20 mg|Participants will receive single oral dose of 20 mg of JNJ-42847922 on Day 1, fasted condition.
16045838|NCT02555124|Drug|JNJ-42847922, 40 mg|Participants will receive single oral dose of 40 mg of JNJ-42847922 on Day 1, fasted condition.
16045839|NCT02555124|Drug|Placebo|Participants will receive placebo on Day 1, fasted condition in Cohort A, Cohort B and Cohort C.
16045840|NCT02555111|Drug|Xarelto|15mg/day oral administration during 2 to 4 years (based on the recruitment date).
16045841|NCT02555098|Device|Sapphire contact lenses|Each subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair
16045842|NCT02555098|Device|senofilcon A contact lenses|Each subject randomized to wear either the test or control contact lenses as a matched pair and cross over to the second matched pair
16045843|NCT02555085|Biological|BIIB063|Single ascending IV dose
16045844|NCT02555085|Other|Placebo|Single dose
16045845|NCT02555072|Biological|yellow fever vaccine|yellow fever vaccination in naive individuals who leaves in a state where this type of vaccination is not recommendated
16045846|NCT02555059|Drug|Cipro (Ciprofloxacin, BAYQ3939)|Treatment parameters following the physician's decision based on the summary of product characteristics.
16045847|NCT02555046|Procedure|Local Anesthesia|Use of unspecified local anaesthesia (fx lidocain or bupivacaine)
16045848|NCT02555033|Other|Resistance training|traditional resistance training
16045849|NCT02555033|Other|Instability resistance training|training under unstable conditions
16045850|NCT02555020|Dietary Supplement|Allocated to Carbohydrated group|Patients received 400 mL of oral isotonic glucose (No NPO®, Daesang, Korea) 12 hours before anesthesia and 400 mL 2 hours before. CHL composition was standard: 12.5 g of carbohydrate per 100 mL, 12% monosaccharide, 12% disaccharide, 76% polysaccharide, 250 mOsm/kg and 50 kcal.
16045851|NCT02555020|Dietary Supplement|Allocated to Placebo group|Patients received 400 mL of oral free water (Placebo) 12 hours before anesthesia and 400 mL 2 hours before.
16045852|NCT02555020|Dietary Supplement|Allocated to MN NPO group,|Patients received NPO from MN.
16045853|NCT02555007|Drug|Vinorelbine|
16045854|NCT02554994|Other|Multifactorial intervention|"There are six components of intervention in this study.
~For all participants:
~Group exercise
~Nutritional supplement(commercial liquid formula will be provided every day).
~For selected participants:
~Wellness visit in primary care setting, polypharmacy and multi-morbidity every month.
~At risk of depression(the people identified as high risk of depression would meet psychiatrist every month).
~Domestic safety(If there are possible hazards in participants' home, social worker provide amendments for getting rid of it)."
16045855|NCT02554994|Other|Usual care|"Experienced nurses will visit all participants every month during 6 months of study period, and will conduct an interview and comprehensive geriatric assessments to collect information regarding physical, nutritional, mental, mood condition and health related quality of life.
~According to ASPRA cohort schedule, all participants will be assessed by the composite measurement method composed of K-FRAIL frailty scare, Mini-Nutritional Assessment Short Form(MNA-S), the Korean version of Mini-Mental State Examination(K-MMSE), Center for Epidemiological Studies depression(CES-D), EQ-5D 3 level version from EuroQol Research Foundation(EQ-5D 3 level), Short Physical Performance Battery(SPPB), and the Cardiovascular Health Study(CHS)."
16045856|NCT02554981|Drug|Cyclosporine 0.05% Ophthalmic Emulsion|Cyclosporine 0.05% Ophthalmic Emulsion (RESTASIS®) 1 drop instilled in each eye twice a day.
16045857|NCT02554968|Other|Questionnaires|
16045858|NCT02554955|Drug|Daclizumab|Participants will receive IV daclizumab (2 mg/kg within 6 hours after transplantation and 1 mg/kg every 2 weeks) for a total of five doses.
16045859|NCT02554955|Drug|Mycophenolate mofetil|Participants will receive mycophenolate mofetil orally (one dose of 1.5 mg within 12 hours pretransplant, 1.5 mg BID within first week and 1 g/day BID from second week onwards) for 6 months.
16045860|NCT02554955|Drug|Silrolimus|Participants will receive sirolimus orally (3 mg/day) for 6 months.
16045861|NCT02554942|Drug|Epoetin beta|Participants will receive weekly SC injections of epoetin beta beginning at 450 IU/kg, with doses adjusted according to hemoglobin level. Treatment will continue for a total of 16 weeks.
16045862|NCT02554929|Behavioral|Taming Sneaky Fears|Parents receive coping strategies based on CBT in parent group and children receive coping strategies based on CBT in child group.
16045863|NCT02554929|Behavioral|Parent Psycho-education and Child Socialization|Parents receive psycho-education in parent group and children receive socialization skills in child group.
16045864|NCT02554916|Behavioral|Dual-Belt Exercise|The dual-belted exercise treadmill can control the speeds of the right and left legs individually. When asymmetric, the dual-belt treadmill imposes mechanical and sensory perturbations independently to each leg such that the central nervous system (CNS) must solve and adapt to the challenge to maintain walking.
16045865|NCT02554916|Behavioral|Treadmill Exercise|The treadmill exercise will maintain the speed of the right and left leg together while walking.
16045866|NCT02554916|Other|Usual Care|This group will not be assigned to a treadmill but is as a non-exercising control group.
16045867|NCT02554916|Device|Dual-Belt Treadmill|
16045868|NCT02554903|Drug|Macitentan 10mg|2 groups, randomized in a 1:1 ratio by an Interactive Voice/Web Randomization System to macitentan 10 mg or placebo
16045869|NCT02554903|Drug|Placebo sugar pill|2 groups, randomized in a 1:1 ratio by an Interactive Voice/Web Randomization System to macitentan 10 mg or placebo
16045870|NCT02554890|Drug|sacubitril/valsartan (LCZ696)|sacubitril/valsartan (LCZ696) tablet with minimum dose 24/26 mg, maximum dose 97/103 mg twice daily administered orally.
16045871|NCT02554890|Drug|Enalapril|Enalapril tablet with minimum dose 2.5 mg, maximum dose 10 mg twice daily administered orally.
16045872|NCT02554890|Drug|sacubitril/valsartan (LCZ696) matching placebo|matching placebo of sacubitril/valsartan (LCZ696) tablet with minimum dose 24/26 mg, maximum dose 97/103 mg twice daily administered orally.
16045873|NCT02554890|Drug|enalapril matching placebo|enalapril matching placebo tablet with minimum dose 2.5 mg, maximum dose 10 mg twice daily administered orally.
16045874|NCT02554877|Drug|PF-06291874|study drug to be given as an oral tablet at 30, 60 or 100 mg
16045875|NCT02554877|Drug|Placebo|oral tablet
16045876|NCT02554864|Drug|lidocaine|Local anesthetic
16045877|NCT02554864|Drug|ropivacaine|Local anesthetic
16045878|NCT02554851|Drug|recombinant human Epidermal Growth Factor (rhEGF)|The Heberprot-P® is a parenteral formulation, which is in a lyophilized powder vial presentation containing 75μg of recombinant Epidermal Growth Factor (rhEGF) for local application (intralesional) with the therapeutic potential to promote granulation and wound healing of DFU. The rhEGF is a polypeptide of 53 amino acids and has the ability to stimulate fibroblasts, keratinocytes and vascular endothelial cells proliferation. Then it contributes to its properties in scar tissue formation. The action mechanism is based on the interaction with specific receptors located on specifics cell membranes. The rhEGF was developed through recombinant DNA technology and it has been produced by biotechnological methods in Saccharomyces cerevisiae yeast line.
16045879|NCT02554851|Other|Placebo|This group will receive the standard medication and the placebo drug. The placebo drug has the same formulation, except for the fact that it does not contain the recombinant human Epidermal Growth Factor (rhEGF).
16045880|NCT02554838|Other|Physical activity|Participants receive a weekly individual session of physical activity during 8 consecutive weeks conducted by a licensed physical therapist and focusing on muscle strengthening, flexibility, gait and balance retraining.
16045881|NCT02554838|Other|Home assessment and modification|Two home-based sessions of modification of the home environment by a licensed rehabilitation therapist, in order to increase the aera of mobility, the frequency of moving in this aera and the independence to move.
16045882|NCT02554838|Behavioral|Cognitive behavioral therapy|Participants receive during 8 consecutive weeks a weekly individual sessions of CBT and a booster session one month later conducted by a psychologist specialized in CBT focusing on : functional analysis, education about treatment and anxiety, relaxation training and progressive exposure in imagination then in vivo.
16045883|NCT02554825|Behavioral|Healthy Futures|Healthy Futures is an age-appropriate program that targets change at different social ecological levels-individual, interpersonal, and organizational. The main component is a classroom-based relationship education curriculum, Nu-CULTURE, offered in 6th, 7th, and 8th grade for eight 50-minute sessions each year. A number of supplemental efforts aim to enhance the Nu-CULTURE program and create social supports: 1) virtual classrooms where participating youth are encouraged to visit age-appropriate youth websites; 2) daily interactive parental connection forms linked with Nu-CULTURE, a parent website, and workshops (True Connections); 3) a 10-week after-school program, Rhymin' it Write, encourages youth leadership; 4) a 6-week summer program, Code A, engages youth during out-of-school time after 8th grade.
16045884|NCT02554825|Behavioral|Control|The Control Curriculum offers students in the control group two 50-minute classes each year on general health education topics. Students in the 6th grade receive a class on puberty/reproduction and a class on bullying prevention; students in the 7th grade receive two classes on dating-violence prevention; and students in the 8th grade receive two classes on mental health promotion.
16045885|NCT02554812|Drug|Avelumab|Anti-PD-L1 antibody
16045886|NCT02554812|Drug|Utomilumab|Anti-4-1BB antibody
16045887|NCT02554812|Drug|PF-04518600|OX40 Agonist
16045888|NCT02554812|Drug|PD 0360324|Anti-M-CSF
16045889|NCT02554812|Drug|CMP-001|TLR9 agonist
16045890|NCT02554799|Drug|MMV390048 formulation A|MMV390048 formulation A, tablet
16045891|NCT02554799|Drug|MMV390048 formulation B|MMV390048 formulation B, tablet
16045892|NCT02554786|Drug|Indacaterol acetate/Mometasone furoate|
16045893|NCT02554786|Drug|Mometasone furoate|
16045894|NCT02554786|Drug|Salmeterol xinafoate/fluticasone propionate|
16045896|NCT02554760|Device|The ZELTIQ CoolSculpting System|The CoolSculpting device and CoolCore applicator with and without the Crown Cooling Insert will be used to perform the treatments.
16045897|NCT02554747|Device|Navigated laser|Aflibercept, Navilas®
16045898|NCT02554747|Device|Conventional laser|Aflibercept, Pascal
16045899|NCT02554734|Drug|levodopa, carbidopa, ODM-104|
16045900|NCT02554734|Drug|levodopa, carbidopa, entacapone|
16045901|NCT02554721|Drug|Cilostazol|
16045902|NCT02554721|Drug|Acetylsalicylic acid|
16045903|NCT02554721|Drug|Clopidogrel|
16046101|NCT02553265|Drug|Carbidopa High Dose|
16045904|NCT02554708|Device|implantation of the pCONus Bifurcation Aneurysm Implant|The device will be introduced through a regular microcatheter. After deployment of the device with the crown positioned in the aneurysm neck the aneurysm will be entered with a microcatheter to perform endovascular coil occlusion. After completion of the coiling procedure the pCONus device will be electrolytically detached from the insertion wire and only the crown and the shaft will remain as a permanent implant.
16045905|NCT02554695|Drug|placebo|subcutaneous saline injection
16045906|NCT02554695|Drug|denosumab|single subcutaneous injection of denosumab 60 mg
16045907|NCT02554682|Behavioral|Sexual Health|Psychoeducational workbook, worksheets, tip sheets, and health coaching session about sexual health, sexually transmitted disease (STD) prevention, and safe sex practices for teenager.
16045908|NCT02554682|Behavioral|Alcohol Prevention|Psychoeducational workbook, worksheets, tip sheets, and health coaching session about alcohol prevention and safety, underage drinking, and drinking and driving.
16045909|NCT02554682|Behavioral|Teen Driving|Psychoeducational workbook, worksheets, videos, tip sheets, and health coaching session about how parents can help supervise their teens' safe driving practices and how to talk with their teen about important safety topics for teen drivers.
16045910|NCT02554669|Behavioral|postprandial and postabsorptive physical activity on treadmill|
16045911|NCT02554643|Other|Diet|Nutrition intervention, once a week during 12 weeks
16045912|NCT02554643|Other|Soccer|Nutrition intervention, once a week during 12 weeks + Soccer training, 3 x week, during 12 weeks
16045913|NCT02554643|Other|Running|Nutrition intervention, once a week during 12 weeks + Running training, 3 x week, during 12 weeks
16045914|NCT02554630|Other|Adjuvant|Blood will be incubated, ex-vivo, with one of the adjuvant therapies or no adjuvant and then, using microfluidic techniques the immune genomic profile and the functional capacity of immune cells will be assessed.
16045915|NCT02554630|Other|Blood Collection|Blood collection will be performed on all groups.
16045916|NCT02554578|Other|Multidisciplinary follow-up programme supported by mHealth|"The follow-up programme integrates an online health platform (app and web) to monitor patients remotely, into the multidisciplinary team workflow, in order to improve heart transplant management.
~Patients will use the mobile application designed to help them to manage their health issues and facilitate communication with the transplant team.
~Data recorded manually by the patient using the mHealth application include pharmacotherapeutic information (medication adherence, barriers to adherence, side effects, interactions, etc.), clinical symptoms and other relevant clinical information (blood pressure, cardiac frequency, exercise, glucose level, diet, mood, etc.).
~mHealth will be used by the transplant team as a complementary way of deliver patient care. Analysis of the data collected by the multidisciplinary team may help to prioritise and provide personalized pharmacotherapeutic and medical interventions to patients and their families."
16045917|NCT02554565|Procedure|Tumor biopsy|Tumor biopsy before treatment
16045918|NCT02554565|Procedure|Blood sampling|Blood sample before, during and after treatment
16045919|NCT02554552|Drug|YY1201 2ml|YY1201 2ml
16045920|NCT02554552|Drug|Placebo 2ml|phosphate buffered saline 2ml
16045921|NCT02554552|Drug|YY1201 3ml|YY1201 2ml
16045922|NCT02554552|Drug|Placebo 3ml|phosphate buffered saline 3ml
16045923|NCT02554539|Procedure|Endometrial fluid aspiration|Patient will undergo a biopsy to aspirate endometrial fluid from the uterine cavity
16045924|NCT02554513|Device|EPG Tx|behavioral intervention that incorporates a device that provides visual biofeedback
16045925|NCT02554513|Behavioral|SPT|A treatment hierarchy involving integral stimulation
16045926|NCT02554500|Procedure|Remote Ischemic Preconditioning (by Blood Pressure Cuff)|Remote Ischemik Preconditioning is performed using a Blood Pressure Cuff with a pressure slightly above patients' blood pressure on the upper arm.
16045927|NCT02554487|Device|AirCurveTM10 CS PACEWAVE Adaptive-Servo-Ventilator (ResMed Ldt., Australia)|Adaptive Servo-Ventilation (ASV) is a ventilator mode used to treat central and obstructive forms of sleep disordered breathing. It is authorized in Switzerland, bears a conformity marking (CE 0123) and it is used according to the approved indications. Stroke patients with an AHI > 20/h assessed within the first night following stroke that are randomized to ASV treatment, starting in the second night after stroke, are part of this group. The other half of patients are randomized to no treatment and patients without sleep disordered breathing (AHI < 5) following stroke serve as a control group
16045928|NCT02554474|Behavioral|Education, Fitbit/FitViz, physiotherapist counselling.|Participants will receive a brief education session, use a physical activity tracker Fitbit Flex with paired with a FitViz app, and remote counseling by a PT. Intervention will be received immediately.
16045929|NCT02554474|Behavioral|Same intervention with a 9-week delay|The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 9-week delay.
16045930|NCT02554461|Other|advise for exercices given by team staff|"To respond to questions asked:
~it is not the investigator who decides on the intervention, but the daily team staff (e.g. trainer, coach, PT,.....). So no predetermined intervention is provided"
16045931|NCT02554448|Other|ISET system|Use ISET system to test the number of CTCs from patients before and during treatment.
16045932|NCT02554435|Device|EAM|The monitor provides the participant feedback on their daily steps, active time, idle time, burned calories, and distance traveled through the mobile application (app). Participants can review all of their feedback while in the intervention. If the participants chose, they are also able to monitor their sleep and dietary intake. The app also provides health tips and daily challenges. The participants will also have the opportunity to interact with other participants through the social features of the app.
16045933|NCT02554435|Behavioral|5 A's counseling|Brief counseling to encourage behavioral change. The counseling is intended to be administered by a health care provider. The component of the counseling are assess, advise, agree, assist, and arrange.
16045934|NCT02554435|Device|Pedometer|The pedometer provides the participant feedback on their daily steps, activity time, distance traveled, and calories burned. Participants can review the feedback for the past 7 days.
16045935|NCT02554422|Device|PalpEar|Palpation of the middle-ear ossicles using the PalpEar device, to measure mobility of the ossicle chain
16045936|NCT02554409|Biological|Quadrivalent Intradermal Influenza Vaccine (QIV)|No Intervention as part of this protocol
16045937|NCT02554396|Drug|PRX-100|ophthalmic solution
16045938|NCT02554396|Drug|Placebo|saline ophthalmic solution
16045941|NCT02554370|Behavioral|Psychoeducational programme|4 sessions of psychoeducation before and 3 after surgery for subthalamic deep brain stimulation
16045942|NCT02554357|Drug|Exparel block in arthroscopic shoulder surgery|The interscalene block will be performed with ultrasound guidance and nerve stimulation.
16045943|NCT02554357|Drug|Bupivacaine block in shoulder surgery|The interscalene block will be performed with ultrasound guidance and nerve stimulation.
16045944|NCT02554344|Drug|Curcumin|Patients will receive 500mg of curcumin administered orally, twice a day for 12 weeks.
16045945|NCT02554331|Radiation|FP-CIT single-photon emission computed tomography|FP-CIT radiolabeled is used as a surrogate marker to examine the integrity of the dopaminergic nigrostriatal neurons.
16045946|NCT02554331|Behavioral|neuropsychological evaluation|"Assessment of:
~overall cognitive function
~executive functions
~visuospatial functions
~Nonverbal memory
~verbal memory
~Evaluation of hearing ability of time perception and sensorimotor synchronization from selected tasks the Battery of assessment of auditory sensorimotor and timing abilities
~Beck Depression Inventory"
16045947|NCT02554331|Other|Gait recording with sensors|Gait recording with sensors
16045948|NCT02554318|Drug|Rifampicin|
16045949|NCT02554318|Drug|Isoniazid|
16045950|NCT02554318|Drug|Pyrazinamide|
16045951|NCT02554318|Drug|Ethambutol|
16045952|NCT02554318|Dietary Supplement|Fermented soybean|
16045953|NCT02554305|Device|fusion oxygenation system|The fusion oxygenation system is a novel design of the pump oxygenator used in cardiopulmonary bypass, integrating multiple new engineering concepts that have altered its performance profile.
16045954|NCT02554305|Device|Affinity oxygenation system|The affinity oxygenation system is the classical pump oxygenator used in cardiopulmonary bypass surgeries
16045955|NCT02554292|Device|Drug Coated Balloon Angioplasty, Scoring Balloon Dilatation|Percutaneous Coronary Intervention
16045956|NCT02554279|Drug|menotropin|
16045957|NCT02554279|Drug|recombinant FSH|
16045958|NCT02554266|Device|Lutonix 014 Drug Coated Balloon PTA Catheter|Drug Coated Balloon PTA Catheter for Treatment of Below-the-Knee (BTK) Arteries
16045959|NCT02554253|Drug|Ketamine|Ketamine used for induction
16045960|NCT02554253|Drug|Propofol|Propofol for induction
16045961|NCT02554240|Drug|DA-5202 20mg|once a week, intra-articular injection, for 3 weeks
16045962|NCT02554240|Drug|DA-5202 10mg|once a week, intra-articular injection, for 3 weeks
16045963|NCT02554240|Drug|Na Hyaluronate 20mg|once a week, intra-articular injection, for 3 weeks
16045964|NCT02554227|Other|Cytokine Profile and suPAR|Routine blood collection will be carried out directly before surgery and also during the stationary hospitalization on day 4 and day 10. Additional blood collection will be done after 6 weeks and 3 months during the follow-up.
16045965|NCT02554214|Device|Glafkos drainage device|
16045966|NCT02554201|Device|Electrical pudendal nerve stimulation|Four sacral points are selected. The two upper points are located about 1 cm bilateral to the sacrococcygeal joint. Needles of 0.40 Х 100 mm are inserted perpendicularly to the upper points to a depth of 80 to 90 mm to produce a sensation referred to the urethra or the anus. The two lower points are about 1 cm bilateral to the tip of the coccyx. Needles of 0.40 Х 100 or 125 mm are inserted obliquely to the lower points towards the ischiorectal fossa to a depth of 90 to 110 mm to produce a sensation referred to the urethra. After the sensation referred to the above regions is produced, each of two pairs of electrodes from a G6805-2 Multi-Purpose Health Device is connected with the two ipsilaterally needles.
16045967|NCT02554201|Device|Transvaginal electrical stimulation|A neuromuscular stimulation therapy system (PHENIX USB 4，Electronic Concept Lignon Innovation, France) is used for TES
16045968|NCT02554188|Biological|Seasonal influenza (flu) vaccine|"Seasonal influenza (flu) vaccine
~Fluzone Quadrivalent Vaccine (Sanofi Pasteur), for participants ages 50 - 64 years old
~Fluzone High-Dose (Sanofi Pasteur), for participants ages 65 years and older"
16045969|NCT02554188|Other|Diet|A 5-day low calorie fasting-mimicking diet
16045970|NCT02554175|Drug|Propofol|Propofol was administered to achieve target propofol Ce
16045971|NCT02554162|Other|Rye products with varying structures|The satiating effect of rye products with various structures will be studied
16045972|NCT02554149|Radiation|Radiological measurement of femoral stem version|particular radiographs( lateral decubitus view) and CT scans
16045973|NCT02554136|Drug|HGP0918|
16045974|NCT02554136|Drug|HGP0816|
16045975|NCT02554136|Drug|HGP0918 + HGP0816|
16045976|NCT02554123|Drug|Vitamin E ointment application|Vitamin E ointment application. Every 12 hours during 7 days.
16045977|NCT02554123|Drug|Vaseline ointment application|Vaseline ointment application. Every 12 hours during 7 days.
16045978|NCT02554110|Device|Stimulator active device|This is a stimulator active device that delivers peripheral nerve stimulation in conjunction with pulse oximetry information.
16045979|NCT02554110|Device|Stimulator sham Device|This is an stimulator sham device that is not providing peripheral nerve stimulation.
16045980|NCT02554097|Procedure|endoscopic sphincterotomy|Sphincterotomy (EST) is performed to remove the common bile duct stone.
16045981|NCT02554097|Procedure|laparoscopic common bile duct exploration|Transductal exploration was carried out to remove the common bile duct stone. Primary closure or a T tube drainage was performed according to the results of transductal surgery.
16045982|NCT02554097|Procedure|laparoscopic transcystic common bile duct exploration|A wide local dissection of Calot's triangle is performed and a 2.8mm, 3-mm or 5-mm flexible choledochoscope according to the diameter of the cystic duct is inserted through the cystic duct into the common bile duct. After the common bile duct stone is removed, the cystic duct was ligated with Hem-o-lok.
16045983|NCT02554097|Procedure|laparoscopic cholecystectomy|Laparoscopic cholecystectomy is performed to remove the gallbladder.
16045984|NCT02554084|Other|Optical Coherence Tomography|Digital images of tear film
16045985|NCT02554071|Other|Pharmacist - Smoking Cessation Support|Intervention mirrors clinical practice with smoking cessation counselling -- patients receive smoking cessation product at no cost and pharmacists are paid flat fee for providing counselling
16046742|NCT02548585|Drug|Placebo|Placebo administered subcutaneously.
16045986|NCT02554058|Device|Cycling and Mechanical stimulation|Cycling and Mechanical stimulation : 30 minute cycling training, 3 times a week for 8 weeks.
16045987|NCT02554045|Drug|Tadalafil|Patients will take tadalafil 2.5 mg tablet every morning for 8 weeks and then withdraw tadalafil for 8 weeks
16045988|NCT02554045|Drug|Placebo|Patients will take placebo tablet every morning for 8 weeks and then withdraw placebo for 8 weeks
16045989|NCT02554032|Procedure|Axillary artery cannulation|The right axillary artery will be exposed via an infraclavicular incision and a Dacron graft sewn to it in an end to side fashion after 5000 units of IV heparin. Following median sternotomy and full systemic heparinization, CPB will be initiated and the patient cooled. The base of the innominate artery will be clamped, and antegrade cerebral perfusion will be provided via the axillary artery. Following completion of the distal open aortic anastomosis, the clamp on the innominate artery will be removed, CPB via the aorta will be resumed and the patient will be rewarmed. After completion of surgery and weaning from CPB, the axillary artery graft will then be removed, the artery repaired and the skin will be closed.
16045990|NCT02554032|Procedure|Innominate artery cannulation|After median sternotomy, systemic heparinization, cannulation of the ascending aorta and right atrium, CPB and systemic cooling will be initiated. The ascending aorta, proximal arch and the base of the innominate artery will be mobilized. Purse-string sutures are placed on the anterior wall of the proximal innominate artery and a pediatric venous cannula inserted using a J wire and sequential dilatation. Circulatory arrest with ACP is provided by clamping the base of the innominate artery and connecting the afferent limb of the CPB circuit to the innominate cannula. Once the distal aortic anastomosis is completed, ACP is discontinued, and full CPB via the aortic graft is resumed. Rewarming and the remaining surgery are then completed.
16045991|NCT02554019|Biological|BT063|Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)
16045992|NCT02554019|Biological|Placebo|Repeated IV infusions over 12 weeks (at weeks 0, 1, 2, 4, 6, 8, 10, 12)
16045993|NCT02554006|Behavioral|good clinical practice|education from physician regarding dual antiplatelet therapy as part of the routine discharge process
16045994|NCT02554006|Behavioral|bundle group|visits and materials describing advantages and side effects of dual antiplatelet therapy and their management
16045995|NCT02553993|Device|Wii Fit(30 Mins)|Receive Wi Fit games training for 30 minutes. There are 2 sections for 1 week; the intervention period will be 12 weeks.
16045996|NCT02553993|Device|Tetrax biofeedback(30 Mins)|Receive Tetrax biofeedback games training for 30 minutes. There are 2 sections for 1 week; the intervention period will be 12 weeks.
16045997|NCT02553993|Other|Conventional weight-shifting(30 Mins)|Receive weight-shifting exercise training for 30 minutes. There are 2 sections for 1 week; the intervention period will be 12 weeks.
16045998|NCT02553980|Behavioral|Follow Your Virtual Trainer (FYVT) program|"Participants in intervention group will under the instruction of a web-based computer software termed Virtual Trainer, which interact with their smartphone apps, to conduct a 3-month self-planned PA training program. A serious of online video seminars related to healthy lifestyle advice will be released to the participants among 3 months. After that, 6 months observation will be followed."
16045999|NCT02553980|Other|Daily PA recommendation & healthy lifestyle suggestions|A written advice of daily PA recommendation, and the textual content of the healthy lifestyle seminars will be provided to the participants.
16046000|NCT02553967|Device|Functional MRI|Functional MRI
16046002|NCT02553941|Drug|Azacitidine|Given intravenous or subcutaneous
16046003|NCT02553941|Drug|Ibrutinib|Given by mouth once daily
16046004|NCT02553928|Drug|Memantine (once daily)|
16046005|NCT02553928|Drug|Memantine (twice daily)|
16046006|NCT02553915|Other|Placebo|Soybean oil placebo
16046007|NCT02553915|Drug|EPA 1 g/day|Omega-3 fatty acid extracted from fish oil, 1 g/day
16046008|NCT02553915|Drug|EPA 2 g/day|Omega-3 fatty acid extracted from fish oil, 2 g/day
16046009|NCT02553915|Drug|EPA 4 g/day|Omega-3 fatty acid extracted from fish oil, 4 g/day
16046010|NCT02553902|Device|Sleep position trainer|
16046011|NCT02553902|Device|Mandibular advancement device|
16046012|NCT02553902|Device|Continuous positive airway pressure|
16046013|NCT02553889|Drug|ISIS 416858|subcutaneous injection
16046014|NCT02553889|Drug|Placebo|subcutaneous injection
16046015|NCT02553863|Procedure|Acupuncture|Acupuncture for 30min [twice weekly for 8 weeks]
16046016|NCT02553863|Procedure|Standard care|Standard care
16046017|NCT02553837|Biological|Hantavax injection|A single 0.5mL dose intramuscular or subcutaneous injection
16046018|NCT02553824|Drug|Phentermine/Topiramate-First|Patients randomly assigned to this Arm will have a 4 week ramp up period (in which doses will be increased, as tolerated, starting from 3.75 mg/23 mg, 7.5 mg/46 mg ,11.25 mg/69 mg , 15 mg/92 mg taken once daily in the morning. For the final 8 weeks, participants will take the 15mg/92 mg (or highest dose tolerated). Then will have a 2 week washout followed by a crossover to 12 weeks of control medication/ placebo.
16046019|NCT02553824|Drug|Placebo|Patients randomly assigned to this Arm will have begin with 12 weeks of placebo followed by a 2 week washout. They will then crossover to Qsymia and receive a 4 week ramp up period (in which doses will be increased, as tolerated, starting from 3.75 mg/23 mg, 7.5 mg/46 mg ,11.25 mg/69 mg , 15 mg/92 mg taken once daily in the morning. For the final 8 weeks, participants will take the 15mg/92 mg (or highest dose tolerated).
16046020|NCT02553811|Diagnostic Test|accuracy diagnostic|effectiveness of the ultrasonography and electromiography for best performance and diagnostic accuracy in carpal tunnel syndrome
16046021|NCT02553798|Drug|Glycopyrronium Topical Wipes|Glycopyrronium Topical Wipes
16046022|NCT02553785|Device|Revivent TC|
16046023|NCT02553772|Drug|Carboxymethylcellulose Based Eye Drop|Carboxymethylcellulose based eye drop (OM3 Tear) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
16046024|NCT02553772|Drug|Carboxymethylcellulose Sodium 0.5%|Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.
16046025|NCT02553759|Other|Actions observed|Patients observed movements without realize them. After this actions, movements will be imagined by patients
16046026|NCT02553746|Device|Detection of the puncture site by ultrasound scan of the lumbar spine.|Neuraxial anesthesia will be performed to the patients after detection of the puncture site by ultrasound scan of the spine. The scanning will be performed as described by Arzola et al. The L3-L4 space will be identified by palpation and identification of the landmarks (Tuffier's line). The ultrasound probe will be placed perpendicular to the long axis of the spine. The spinous process will be identified (bright signal followed by dark triangular area). The probe will be moved to cephalad or caudal to identify the intervertebral space and when the best view of the ligamentum flavum is achieved two marks will be drawn on the skin: one at the center of the upper surface of the probe and one at the center of the right lateral vertical side of the probe. The intersection of the two landmarks will be the puncture site. The distance from the skin to the ligamentum flavum will be measured by the ultrasound caliper.
16046027|NCT02553746|Procedure|Detection of the puncture site by identification of the landmarks.|Neuraxial anesthesia will be performed to the patients after detection of the puncture site by the identification of the landmarks. The L3-L4 space will be identified by palpation of the posterior iliac crests and the ideal intervertebral space will be selected after palpation of the spinous processes.
16046028|NCT02553733|Drug|Beetroot juice|This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK).
16046029|NCT02553733|Drug|Beetroot juice placebo|This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK).
16046030|NCT02553720|Other|exercise in water|The patients will be instructed to perform walking or swimming for 15 minutes, 3 times a week for 3 months in a swimming pool in addition to conventional management
16046031|NCT02553720|Other|aquatic activity plus conventional management|walking in water or swimming for 15 minutes, 3 times a week for 3 months in a swimming pool in addition to conventional management
16046032|NCT02553707|Drug|Ibandronate|Participants will receive ibandronate 6 mg IV on Days 1, 2, and 3.
16046033|NCT02553694|Other|Enhanced education|Investigator created video to help educate subject before the in-laboratory split night polysomnogram. The subject will watch the short video immediately prior to the initiation of the in-laboratory polysomnogram.
16046034|NCT02553694|Other|Usual education|Usual education by American Academy of Sleep Medicine (AASM)- created educational pamphlets
16046035|NCT02553694|Other|Usual follow up|MD will follow up by phone after the in-laboratory split night polysomnogram
16046036|NCT02553694|Other|Enhanced follow up|Sleep center non-MD staff member will follow up by phone after the in-laboratory split night polysomnogram
16046037|NCT02553681|Device|roflufocon D contact lenses|HPT treated rigid contact lenses
16046038|NCT02553681|Device|RGP contact lenses made from roflufocon D|
16046039|NCT02553668|Drug|Oxygen (FiO2 1,0)|Participants will inhale Oxygen (FiO2 1,0) via Facemask for 3 hours.
16046040|NCT02553668|Device|Facemask|
16046041|NCT02553655|Procedure|4x 5min Limb Preconditioning|A blood pressure cuff is placed over the upper thigh of the participant(s) and inflated to 30 millimeters of mercury (mmHg) above systolic blood pressure. The loss of pedal pulses is confirmed by palpation. The cuff remains inflated for 5min and is followed by 5 minutes of reperfusion/rest. This will be repeated 4 times.
16046042|NCT02553655|Procedure|3x 10min Limb Preconditioning|A blood pressure cuff is placed over the upper thigh of the participant(s) and inflated to 30 mmHg above systolic blood pressure. The loss of pedal pulses is confirmed by palpation. The cuff remains inflated for 10min and is followed by 5 minutes of reperfusion/rest. This will be repeated 3 times.
16046043|NCT02553655|Procedure|3x 10min Sham Preconditioning|A blood pressure cuff is placed over the upper thigh of the participant(s) and inflated to 40 mmHg, sufficient to apply pressure but not affect blood flow. The presence of pedal pulses is confirmed by palpation. The cuff remains inflated for 10min and is followed by 5 minutes of rest. This will be repeated 3 times.
16046044|NCT02553642|Drug|Nivolumab|"Monotherapy Treatment - Nivolumab 240 mg flat dose Dosed q 2 weeks
~OR
~- Nivolumab 480 mg flat dose Dosed q 4 weeks
~for up to 2 years from 1st dose of nivolumab or until loss of clinical benefit"
16046045|NCT02553642|Drug|Nivolumab plus Ipilimumab|"Combination Treatment
~Ipilimumab 3 mg/kg
~Nivolumab 1 mg/kg Dosed q 3 weeks x 4 doses"
16046046|NCT02553629|Drug|Rocuronium|
16046047|NCT02553616|Behavioral|Intervention to Promote Healthy Behaviors|Six individualized sessions (30 minutes each) are delivered to each participant randomized to receive the intervention.
16046048|NCT02553603|Drug|Growth Hormone Releasing Hormone (GHRH)|Growth Hormone Releasing Hormone (GHRH) 1mg/day for 10 weeks
16046049|NCT02553603|Drug|Placebo Growth Hormone Releasing Hormone|Placebo GHRH to be given once daily for 10 weeks
16046050|NCT02553564|Other|Checklist driven clinical encounter after hospital discharge|"Within 96 hours of hospital discharge an Nurse Practitioner will perform a checklist guided assessment to preventing rehospitalizations. The assessment consists of the following:
~The participants's hospital course will be reviewed and their clinical recovery and stability assessed.
~Determination of the participants's estimated dry weight (EDW).
~The participants's post discharge medications will be checked, compared to the prehospitalization medication, and discrepancies will be reviewed and corrected.
~Blood tests will be ordered for the participants's first return dialysis treatment if medically appropriate after clinical assessment.
~Write new dialysis orders.
~Dialysis Access- review access and determine any changes required in treatment"
16046051|NCT02553551|Drug|Vitamin C|"During the period of hospitalization, Intake of vitamin C 3000 mg per day via oral route until the day of discharge.
~After discharge, no additional vitamin C pill was given."
16046052|NCT02553551|Drug|Placebo|"During the period of hospitalization, Intake of gelatinous capsule three times per day via oral route until the day of discharge.
~After discharge, no additional capsule was given."
16046053|NCT02553538|Behavioral|Patient Navigation|Navigators utilized TopCare to track participants, reach out to them in their own language, and provide intense outreach to help them complete cancer screening.
16046102|NCT02553252|Other|Sudarshan Kriya Yoga Trauma Relief Program (SKY)|Participants in the SKY group will undergo a 12-week training course in Sudarshan Kriya Yoga (SKY) conducted by certified instructors from the Art of Living Foundation.
16046103|NCT02553239|Device|CoolLoop®|Cryoablation of Atrial Fibrillation Using the CoolLoop Cryoablation System
16046448|NCT02550652|Drug|Mycophenolate Mofetil/Mycophenolic Acid|MMF/MPA will be administered as per schedule specified in the respective arm.
16046054|NCT02553525|Procedure|Therapeutic Stimulation Patterns|During deep brain stimulation (DBS) electrode implantation or implanted pulse generator (IPG) replacement surgery, different stimulation patterns that are designed to suppress oscillatory neural activity at theta- or beta-frequencies will be delivered in randomized order, and the subject will be blinded to the patterns. Neural activity and/or motor symptoms (tremor and/or bradykinesia) will be measured in response to DBS. Measurements will be made during 2- to 8-minute trials, in which stimulation will be off for the first half of the trial, and on for the remaining half. Neural activity and/or motor symptoms will be measured during both the off and on phases. The total amount of time necessary for data collection will be about 45 minutes.
16046055|NCT02553525|Procedure|Symptogenic Stimulation Patterns|During deep brain stimulation (DBS) electrode implantation or implanted pulse generator (IPG) replacement surgery, different stimulation patterns that are designed to exacerbate oscillatory neural activity at theta- or beta-frequencies will be delivered in randomized order, and the subject will be blinded to the patterns. Neural activity and/or motor symptoms (tremor and/or bradykinesia) will be measured in response to DBS. Measurements will be made during 2- to 8-minute trials, in which stimulation will be off for the first half of the trial, and on for the remaining half. Neural activity and/or motor symptoms will be measured during both the off and on phases. The total amount of time necessary for data collection will be about 45 minutes.
16046056|NCT02553512|Other|Ingestible Sensor and Wearable Sensor|This digital health offering passively acquires and records medication-taking and habits of daily living.
16046057|NCT02553499|Biological|MK-1248|IV infusion
16046058|NCT02553499|Biological|pembrolizumab|IV infusion
16046059|NCT02553486|Other|quality of life evaluation|
16046060|NCT02553473|Drug|Doxycycline|
16046061|NCT02553473|Drug|Placebo|
16046062|NCT02553460|Drug|ITMHA|Given intrathecally (IT).
16046063|NCT02553460|Drug|Dexamethasone|Given orally (PO) or naso-gastrically (NG) or intravenously (IV).
16046064|NCT02553460|Drug|Mitoxantrone|Given IV.
16046065|NCT02553460|Drug|Pegaspargase|Given IV. If participant is allergic to pegaspargase, Asparaginase Erwinia Chrysanthemi will be used.
16046066|NCT02553460|Drug|Asparaginase Erwinia Chrysanthemi|Asparaginase Erwinia Chrysanthemi will be used in case of allergy or intolerance of participant to PEG-asparaginase. Given IV (preferred) or intramuscularly (IM).
16046067|NCT02553460|Drug|Bortezomib|Given IV.
16046068|NCT02553460|Drug|Vorinostat|Taken PO or NG.
16046069|NCT02553460|Drug|Cyclophosphamide|Given IV.
16046070|NCT02553460|Drug|Mercaptopurine|Given PO or NG.
16046071|NCT02553460|Drug|Methotrexate|Given IV, IM or PO.
16046072|NCT02553460|Drug|Leucovorin Calcium|Leucovorin rescue PO or IV.
16046073|NCT02553460|Drug|Cytarabine|Given IV.
16046074|NCT02553460|Drug|Etoposide|Given IV. In case of participant allergy, etoposide phosphate (Etopophos®) will be given.
16046075|NCT02553460|Drug|Vincristine|Given IV.
16046076|NCT02553447|Dietary Supplement|Cholecalciferol|Given PO
16046077|NCT02553447|Other|Laboratory Biomarker Analysis|Optional correlative studies
16046078|NCT02553434|Device|Pigtail catheter|Insertion of pigtail catheter
16046079|NCT02553421|Device|ivWatch Model 400|The ivWatch Model 400 is placed next to the subject's PIV site. All subjects will receive standard care for their IV sites including the normal routine assessments of the IV site by the bedside registered nurses.
16046080|NCT02553408|Device|FreeStyle Precision Neo-Meter|Participants will receive a free glucose meter (Neo) and test strips from their care providers with education and instructions on how to use the meter to monitor their glucose level. Three months after the start of using the meter, participants will be interviewed on their experiences, likes and dislikes about the meter.
16046081|NCT02553395|Device|Phenacite (Test) contact lens|
16046082|NCT02553395|Device|comfilcon A contact lens|
16046083|NCT02553382|Dietary Supplement|Dietary, Herbal|Viscous fibre blend and Salba and American and Korean Red Ginseng capsules
16046084|NCT02553382|Dietary Supplement|Positive Control|Oat bran blend and wheat bran capsules
16046085|NCT02553369|Other|Biological sample collection|A blood sample is collected during a follow up visit for HIV infection.
16046086|NCT02553356|Drug|PT2385|
16046087|NCT02553343|Biological|High-dose quadrivalent influenza virus vaccine|0.5 mL, Intramuscular (IM), injected into the deltoid area
16046088|NCT02553343|Biological|High-dose influenza virus vaccine|0.5 mL, Intramuscular (IM), injected into the deltoid area
16046089|NCT02553343|Biological|High-dose trivalent inactivated influenza vaccine|0.5 mL, Intramuscular (IM), injected into the deltoid area
16046090|NCT02553343|Biological|High-dose trivalent inactivated influenza vaccine|0.5 mL, Intramuscular (IM), injected into the deltoid area
16046091|NCT02553330|Drug|Placebo Cream|
16046092|NCT02553330|Drug|Ruxolitinib Phosphate Cream|
16046093|NCT02553317|Biological|Caplacizumab|"First day of treatment: 10 mg intravenous (i.v.) injection prior to plasma exchange (PE) followed by a 10 mg subcutaneous (s.c.) injection (in the abdominal region) after completion of PE on that day.
~Subsequent days of treatment during PE: daily 10 mg s.c. injection (in the abdominal region) following PE.
~Treatment after PE period: daily 10 mg s.c. injections for 30 days. If the underlying immunological disease was not resolved, treatment could be extended for a maximum of 4 additional 1-week periods (i.e., 28 days) and was to be accompanied by optimization of immunosuppression."
16046094|NCT02553317|Biological|Placebo|"First day of treatment: i.v. injection prior to PE followed by a s.c. injection (in the abdominal region) after completion of PE on that day.
~Subsequent days of treatment during PE: daily s.c. injection (in the abdominal region) following PE.
~Treatment after PE period: daily s.c. injections for 30 days. If the underlying immunological disease was not resolved, treatment could be extended for a maximum of 4 additional 1-week periods (i.e., 28 days) and was to be accompanied by optimization of immunosuppression."
16046095|NCT02553291|Behavioral|SystemCHANGE|
16046096|NCT02553291|Behavioral|Control|
16046097|NCT02553278|Device|VelaShape device|Modified VelaShape radiofrequency device for non invasive fat reduction treatment.
16046098|NCT02553278|Device|Contour I V3 device|Contour I V3 device are non invasive for fat reduction.
16046099|NCT02553265|Drug|Carbidopa Low Dose|
16046100|NCT02553265|Other|Placebo|A placebo containing an inert substance, in capsule form that does not contain an active drug ingredient.
16046104|NCT02553226|Drug|Oxytocin|Both arms will initially receive routine treatment with oxytocin according to national guidelines. When active phase of labour is established both arms will have their infusion-set changed for a blinded infusion-set.
16046105|NCT02553226|Drug|Placebo|Both arms will initially receive routine treatment with oxytocin according to national guidelines. When active phase of labour is established both arms will have their infusion-set changed for a blinded infusion-set.
16046106|NCT02553213|Other|Laparoscopic sleeve gastrectomy|The surgical procedure and aftercare is indicated and performed according to the routine clinical setting of the Hospital. Patients stay 5 days stationary after surgical treatment. They receive a defined easy digestible diet, starting with liquid and mash food.
16046107|NCT02553213|Other|Laparoscopic Roux-en-Y gastric bypass|The surgical procedure and aftercare is indicated and performed according to the routine clinical setting of the Hospital. Patients stay 5 days stationary after surgical treatment. They receive a defined easy digestible diet, starting with liquid and mash food.
16046108|NCT02553213|Other|Caloric restriction diet|Patients of the control group do not undergo surgical treatment. They undergo a caloric restriction diet for 5 days. This diet is adapted to the postoperative diet of the patients included in the two other groups.
16046109|NCT02553213|Other|easy digestible diet|
16046110|NCT02553200|Device|BreatheMAX (OPEP)|for 10 breathes/set, 10 sets/day and rest 1 minute between set
16046111|NCT02553200|Device|BreatheMAX (OIS and OPEP)|for 10 breathes/set, 10 sets/day and rest 1 minute between set
16046112|NCT02553200|Device|BreatheMAX (unload and non-oscillated)|for 10 breathes/set, 10 sets/day and rest 1 minute between set
16046113|NCT02553187|Drug|Kanglaite Injection|"200 mL, slow IV drip, once daily for 14 consecutive days, subsequent courses repeated after a 7-day interval.
~Subjects will be treated for 4 courses (12 weeks)."
16046114|NCT02553161|Drug|Escitalopram|Youth in the MED condition will be given the USFDA approved antidepressant, escitalopram for the treatment of depression or anxiety in youth and follow a standard dose titration schedule of 5 mg/day for 1 week, 10mg/day for 1 week, then with a target dose of 20-30 mg/day by 4 weeks. Titration will be no faster than 5mg/week. This titration guideline was drawn from the escitalopram package insert for pediatric dosing, which states that target doses may be achieved by 4 weeks.
16046115|NCT02553161|Behavioral|Cognitive behavioral Psychotherapy|All participants (No MED and MED) will be assigned a study-trained therapist who will provide hour-long weekly individual cognitive behavioral psychotherapy (CBT) based on current evidence-based practices for the treatment of anxiety and depressive symptoms for youth.
16046116|NCT02553148|Other|Need for children's palliative care|Need for children's palliative care
16046117|NCT02553135|Biological|Injection of AAV2-REP1 (10e11 vg)|Single Group: single arm study
16046118|NCT02553122|Drug|Evicel|Fibrant Sealant to apply on the soft tissue to control intra-operative blood loss
16046119|NCT02553122|Device|tourniquet|A tourniquet is applied to the thigh to stop/ decrease blood flow
16046120|NCT02553096|Device|ACCESS|The ACCESS system consists of a smartphone, a pulse-oximeter, a spirometer and a forehead thermometer. Questions concerning changes in symptoms, physical limitations and emotions are answered by touch screen on the smartphone, complemented by measurements of the pulse-oximeter, spirometer and thermometer. Based on this information, the system calculates the current risk of an exacerbation and, when applicable, the participant will receive personalized instructions about which actions to take in order to manage the exacerbation. Participants are instructed to use ACCESS in case of symptom worsening.
16046121|NCT02553083|Drug|Nexium 40 mg|Nexium 40 mg twice daily for 14 days
16046122|NCT02553083|Drug|amoxicillin 1.5 gr|amoxicillin 1.5 gr twice daily for 14 days
16046123|NCT02553083|Drug|doxycycline 200 mg|doxycycline 200 mg twice daily for 14 days
16046124|NCT02553083|Drug|Nexium 20 mg|Nexium 20 mg twice a day for 10 days
16046125|NCT02553083|Drug|clarythromicin 500 mg|clarythromicin 500 mg twice a day for 10 days
16046126|NCT02553083|Drug|amoxicillin 1gr|amoxicillin 1gr twice a day for 10 days
16046127|NCT02553070|Other|Survey|Pharmacy students will be asked to participate in a short (5-7 minutes) survey (see below) that contains 21-short cases involving an exposure to a pharmaceutical or non-pharmaceutical agent. All cases involve children less than 19 years of age. Participants will be asked to indicate their year in pharmacy school (1st or 2nd) and their gender (female/male).
16046128|NCT02553057|Device|mechanical ventilation|
16046129|NCT02553044|Dietary Supplement|Cholecalciferol (Vitamin D3)|Oral vitamin D3 doses made up using 50 000IU ampules of vitamin D3 dissolved in 1ml of olive oil.
16046130|NCT02553031|Device|The imaging biomarkers determined by MR-PET|This study will explore the potential value in proper therapeutic decision and clinical outcome prediction by using integrated MR-PET system and advanced MR techniques in patients with colorectal cancer.
16046131|NCT02553018|Drug|Methotrexate|
16046132|NCT02553005|Procedure|Acupuncture|
16046133|NCT02552992|Behavioral|Yoga|
16046134|NCT02552992|Behavioral|Self-Directed Mind-Body Program|
16046135|NCT02552979|Other|atopic patch test|
16046136|NCT02552966|Device|UESAD|Device designed to provide modest cricoid pressure to reduce reflux
16046137|NCT02552953|Drug|CYC065|
16046138|NCT02552940|Drug|Tocilizumab|Participants with RA receive TCZ SC, as per routine clinical practice and are followed for approximately 6 months.
16046139|NCT02552927|Device|Chest shield with aluminum foil (CALF)|
16046140|NCT02552927|Device|SHIELD|
16046141|NCT02552914|Device|Colli-Pee|Participants will be asked to use the colli-pee to collect first-void urine and to send it back to the Institute of Tropical Medicine by regular mail.
16046142|NCT02552901|Drug|0.1 mg/kg ICG Dose|least efficacious dose
16046143|NCT02552901|Drug|0.5 mg/kg ICG dose|per package insert
16046144|NCT02552888|Drug|Immediate release sodium nitrite|Immediate release sodium nitrite 40 mg by mouth twice per day
16046145|NCT02552888|Dietary Supplement|Isoquercetin|Isoquercetin 225 mg by mouth once per day
16046146|NCT02552888|Other|placebos|placebos
16046147|NCT02552875|Other|Tetanic stimulation|50 Hz tetanic stimulation before TOF-twitch stabilization with the aim to eliminate the staircase phenomenon
16046148|NCT02552875|Other|Staircase Stimulation|TOF-twitch stabilization without 50 Hz tetanic stimulation with the aim to verify the staircase phenomenon
16046245|NCT02552095|Device|Triathlon PKR|
16046149|NCT02552862|Drug|Vivomixx®|Vivomixx® is a probiotic mixture of 8 proprietary strains, namely Streptococcus thermophilus DSM 24731, bifidobacteria (B. breve DSM 24732, B. longum DSM 24736, B. infantis DSM 24737) and lactobacilli (L. paracasei DSM 24733, L. acidophilus DSM 24735, L. delbrueckii subsp bulgaricus DSM 24734, L. plantarum DSM 24730). The active agent will be supplied as a 4.4g sachet at a dose of 450 billion live bacteria per sachet with maltose and silicon dioxide as excipients.
16046150|NCT02552862|Drug|Placebo|Placebo will be formulated as identical in appearance and administered according to the same schedule as the active agent. Placebo contains maltose and silicon dioxide as inactive agent.
16046151|NCT02552849|Other|No intervention|
16046152|NCT02552836|Behavioral|Interpersonal Psychotherapy|A 12-week intervention that focuses on resolving interpersonal stressors that are linked to the onset, maintenance or exacerbation of depressive symptoms
16046153|NCT02552836|Behavioral|Supportive Psychotherapy|A 12-week intervention that focuses on non-specific factors that contribute to therapy outcome
16046156|NCT02552810|Device|Steam clean|Control group: dental implant abutments underwent cleaning by steam (VAP 1, Zhermark, Cologne, Germany), performed for 5 seconds at 4 megapascal (MPa).
16046157|NCT02552810|Device|Plasma of Argon|Test group: dental implant underwent argon plasma treatment in a plasma reactor (Diener Electronic, Jettingen, Germany). The treatment conditions were 75 W of power and 1 bar of pressure for 12 minutes.
16046158|NCT02552797|Behavioral|Shared Decision Making tool|
16046159|NCT02552784|Behavioral|data assessment of the state of health and quality of life of patients and their families|Study medical determinants, socioeconomic, behavioral, environmental of health, school and professional integration, and short- and medium-term quality of life of all patients residing in France for which the diagnosis of hereditary diseases metabolism with specific diet (MHMRS) was performed during their childhood.
16046160|NCT02552771|Procedure|Mitral repair with leaflet preservation|Placing man-made fibers (sutures) to more securely connect the mitral leaflets to the papillary muscles (muscles located in the ventricle).
16046161|NCT02552771|Procedure|Mitral repair with leaflet resection|Removing one or both of the mitral leaflets that flop or bulge back.
16046162|NCT02552758|Biological|omega-3 fatty acid|omega-3 fatty acid
16046163|NCT02552758|Biological|placebo|placebo
16046164|NCT02552758|Device|positron emission tomography (PET)|
16046165|NCT02552745|Drug|parecoxib sodium|parecoxib sodium was administered postoperatively, when transcatheter arterial embolization finished.
16046166|NCT02552732|Device|NHF with or without Oxygen|NHF using myAIRVO™ 2 will be set at 25L/min at 37°C. However, all participants are able to lower the delivered temperature to 34°C.
16046167|NCT02552706|Dietary Supplement|probiotics|Administration of mixture probiotics 500mg by mouth, one time or divided into 2-4 times depends on the feeding volume until to 36 weeks post menstrual age.
16046168|NCT02552706|Dietary Supplement|glucose solution|Administration of 1 mL of a 5% glucose solution by mouth, one time or divided into 2-4 times depends on the feeding volume until to 36 weeks post menstrual age.
16046169|NCT02552693|Other|Enhanced training, supervision and support|"The intervention includes the following activities:
~Conduct of pre-intervention facility audits; Cross-verification of appointment diaries with facility attendance records; Development and implementation of job aids and tools; Provides supplemental training and technical support to focal facility point (FFP) and other staff, and community health workers (CHWs); Improves coordination, supervision and reporting systems at the health facilities."
16046170|NCT02552680|Other|Exercise|Physical Exercise
16046171|NCT02552680|Other|Guideline|Guideline on care and prevention of Work-Related Musculoskeletal Disorders in activities of daily living, especially those relating work activities.
16046172|NCT02552680|Other|Brochure|Manual/brochure containing information about general health
16046173|NCT02552667|Drug|HCP1102+HGP0711Placebo|Coadministration of HCP1102 with HGP0711 Placebo for 4-week
16046174|NCT02552667|Drug|HCP1102Placebo+HGP0711|Coadministration of HCP1102 Placebo with HGP0711 for 4-week
16046175|NCT02552654|Behavioral|Stress Film|Film scene with severe physical and sexual violence.
16046176|NCT02552654|Drug|Hydrocortisone|10mg
16046177|NCT02552654|Drug|Placebo|
16046178|NCT02552641|Other|Food effect|
16046179|NCT02552641|Drug|Esomeprazole|
16046180|NCT02552641|Drug|Amoxicillin|
16046181|NCT02552641|Drug|Clarythromycin|
16046182|NCT02552628|Device|"Medtronic, Activa® PC on"|
16046183|NCT02552628|Device|"Medtronic, Activa® PC off"|
16046184|NCT02552615|Other|body awareness therapy|
16046185|NCT02552615|Other|core stabilization exercises|
16046186|NCT02552615|Other|traditional exercises|
16046187|NCT02552602|Dietary Supplement|Multivitamin A|Multivitamin containing 7 micronutrients at recommended daily allowance (RDA)
16046188|NCT02552602|Dietary Supplement|Multivitamin B|Multivitamin containing 22 micronutrients at RDA
16046189|NCT02552602|Dietary Supplement|Multivitamin C|Multivitamin containing 22 micronutrients at three times the RDA
16046190|NCT02552589|Other|Amine fluoride|toothpaste
16046191|NCT02552589|Other|Placebo|toothpaste
16046192|NCT02552576|Biological|Voncento|Human coagulation VWF / coagulation factor VIII (FVIII) complex concentrate
16046193|NCT02552563|Behavioral|Dementia Care Management|The intervention involves two main components. The first component includes individualized dementia care management that involves regular and extended contact between the CG, care manager, and when appropriate, Veteran's primary care provider (PCP). The care manager monitors Veterans' symptoms via CG report, provides psychoeducation and support to CGs, influences adherence to guidelines by providing timely and tailored information to PCPs, and suggests appropriate care strategies and service referrals. The second major component is the Telehealth Education Program (TEP). For this pilot study, the program was modified for use with individual CGs and was formatted so that CGs could select from a menu of up to 7 modules covering various content areas evaluated during the course of the care management assessments (e.g., communication skills, behavioral management techniques, stress management and coping skills, long-term planning, etc.).
16046246|NCT02552082|Device|Scorpio NRG posterior stabilized (PS)|
16046247|NCT02552069|Device|Tritanium® cup|
16046194|NCT02552550|Procedure|Ability to swallow, speak and quality of life|This study will not change the patient's treatment. This will just be an evaluation, before any treatment, his ability to swallow, speak, then his quality of life, as in normal practice, after 3, 6 and 12 months after treatment.
16046195|NCT02552537|Drug|Omeprazole|patients with walnut allergy will be exposed during 5 days before food challenge with Omeprazole
16046196|NCT02552537|Drug|Placebo|patients with walnut allergy will be exposed during 5 days before food challenge with Placebo
16046197|NCT02552524|Device|rTMS active then rTMS placebo|A 20 minute session of rTMS active at the frequency of 10 Hz then, 7 days later, a 20 minute session of rTMS placebo
16046198|NCT02552524|Device|rTMS placebo then rTMS active|A 20 minute session of rTMS placebo then, 7 days later, a 20 minute session of rTMS at the frequency of 10 Hz
16046199|NCT02552498|Procedure|strangulation|The strangulation is applied on the attached gingiva with an angulated manual instrument. The force of the occlusion is standardized by a calibrated spring connecting the head with the handle of the tool. The head is overlaid onto the gingiva covering 10mm long and 1mm width surface. The amount of the applied pressure is 100 gram.
16046200|NCT02552485|Other|No intervention was applied, because it is an observational study|
16046201|NCT02552459|Drug|Sufentanil|sufentanil 150μg， intravenous administration during post-operative 72 hours.
16046202|NCT02552459|Drug|dexmedetomidine 1|dexmedetomidine 0.05μg/kg/h, Continuous intravenous injection for 72 hours after operation
16046203|NCT02552459|Drug|dexmedetomidine 2|dexmedetomidine 0.1μg/kg/h, Continuous intravenous injection for 72 hours after operation
16046204|NCT02552459|Drug|dexmedetomidine 3|dexmedetomidine 0.15μg/kg/h, Continuous intravenous injection for 72 hours after operation recorded in the following 72h.
16046205|NCT02552433|Dietary Supplement|protein intake assessment and optimisation|
16046206|NCT02552407|Device|Manual Aspiration Thrombectomy|Thrombus aspiration
16046207|NCT02552394|Drug|huJ591|HuJ591 will be administered as an intravenous infusion at a concentration of 5 mg/mL and rate of <5 mg/minute. Pre-medications prior to J591 infusion with diphenhydramine 25 - 50 mg p.o. or IV and acetaminophen 500 - 650 mg p.o.
16046208|NCT02552381|Other|Fibrin Structure|Modifications of Fibrin Structure in patients who have developed VTE in comparison with patients without VTE.
16046209|NCT02552368|Device|IpsiHand Device|Once a participant has completed (3) EEG Signal Screens and (2) separate set of baseline measurements, the IpsiHand BCI Device is provided to participants to use a minimum of (5) out of (7) days a week for a total duration of 12 weeks. Participants are seen bi-weekly throughout the duration of the trial to assess affected upper extremity and assess functional impact. At the completion of 12 weeks of device use, the participants complete a set of measurements to assess function of the affected upper extremity.
16046210|NCT02552355|Drug|Metformin|Daily administration of Metformin will begin as one 500 mg tablet for the first week and will increase by 500 mg/day/week until reaching 2000 mg/day by week 4 during a 12 week exercise training program.
16046211|NCT02552355|Drug|Placebo|Daily administration of matching placebo during a 12 week exercise training program.
16046212|NCT02552355|Dietary Supplement|Carbohydrate Beverage|Supervised aerobic exercise 3 days per week followed by a carbohydrate drink
16046213|NCT02552355|Dietary Supplement|Protein Beverage|Supervised aerobic exercise 3 days per week followed by a protein drink
16046214|NCT02552342|Drug|methylprednisolone|
16046215|NCT02552342|Drug|Normal saline|
16046216|NCT02552329|Other|Tai Chi exercise|The Tai Chi exercise group will exercise for 50 minutes/session, 3 times /week for 24 consecutive weeks (6 months). Each 50-minute session will include a 10-minute warm up, 30-min exercise, and 10-min cool down, The 10 forms Tai Chi will be used.
16046217|NCT02552316|Device|NB-UVB Phototherapy|
16046218|NCT02552303|Behavioral|Cognitive Behavioral Therapy for Insomnia|Cognitive Behavioral Therapy for Insomnia.
16046219|NCT02552303|Drug|Armodafinil|Active medication
16046220|NCT02552303|Drug|Placebo|Placebo for Nuvigil (armodafinil)
16046221|NCT02552290|Other|Upper Trapezius Stretch|Sustained stretch of upper trapezius muscle
16046222|NCT02552290|Other|Cervicothoracic manipulation|Manipulation to the cervicothoracic spine
16046223|NCT02552290|Other|No intervention|Wait
16046224|NCT02552277|Biological|PDA-002|PDA-002 cells administered intramuscular (IM) on study Days 1, 29, and 57.
16046225|NCT02552277|Drug|Placebo|Subjects will receive placebo administered on study days 1, 29, and 57.
16046226|NCT02552264|Behavioral|Acceptance and Commitment Therapy for the Workplace|Acceptance and Commitment Therapy
16046227|NCT02552251|Biological|Hormonal balance measurements|
16046228|NCT02552251|Biological|metabolic balance measurements|
16046229|NCT02552251|Biological|bone balance measurements|
16046230|NCT02552251|Behavioral|quality of life assessment|
16046231|NCT02552238|Drug|Lumason|Lumason (sulfur hexafluoride-type A microspheres) an ultrasound contrast agent was administered as 2 single 2-mL IV injections during rest and stress echocardiography
16046234|NCT02552212|Biological|Certolizumab Pegol|"Active Substance: Certolizumab Pegol
~Pharmaceutical Form: Prefilled syringe
~Concentration: 200 mg / ml
~Route of Administration: Subcutaneous injection"
16046235|NCT02552212|Other|Placebo|"Active Substance: Placebo
~Pharmaceutical Form: Prefilled syringe
~Concentration: 0.9 % saline
~Route of Administration: Subcutaneous injection"
16046236|NCT02552199|Other|gravimetric|
16046237|NCT02552186|Other|Caliper measurement|Clinical caliper measurements will be taken and used to calculate the Clinical PI
16046238|NCT02552173|Radiation|The Relationship Between Operative and Radiologic Stem Version|intraopertive surgeon's estimation and postoperative CT scan
16046239|NCT02552147|Drug|Transdermal nicotine|
16046240|NCT02552147|Other|Transdermal placebo|
16046241|NCT02552134|Other|exercise training|
16046242|NCT02552134|Other|recommendation to be active|
16046243|NCT02552121|Drug|Tisotumab vedotin (HuMax-TF-ADC)|
16046244|NCT02552108|Behavioral|Behavioural experiments for intolerance of uncertainty (BE-IU)|
16046248|NCT02552056|Other|CAMH training|Training of PHC workers included in the study for 5 days to screen children and adolescents for CAMH conditions, based in the mhGAP curriculum for non-specialist health providers.
16046249|NCT02552043|Other|Nintendo Wii exercise program|The aerobic training protocol was designed to improve muscular strength, body endurance and flexibility (involved activities as: running, up the knees, butt kickers, etc.). The game used has a strap pouch to hold the Nunchuk© controller placed on the thigh that detects the lower body movements, and also features a number of exercise options supervised by a virtual personal trainer
16046250|NCT02552030|Device|cuff device (Omron HBP-1300-E Pro)|Comparison of systolic blood pressure results measured with an oscillometric cuff device (Omron HBP-1300-E Pro) and iPhone 4s
16046251|NCT02552030|Device|iPhone 4s|
16046252|NCT02552017|Device|Endocuff Vision|Endocuff Vision is a new device made of soft plastic material with a unique dynamic shape. It is manufactured by ARC Medical Design Limited and Diagmed in the United Kingdom. It has European Conformity in United Kingdom. The core is made of polypropylene and the 'finger like' projections are made of a thermoplastic elastomer. It comes in four colour coded sizes (purple, blue, green and orange) to fit a range of paediatric and adult colonoscopes. Endocuff Vision is the more updated version of device that has only one proximal row of more rounded finger-like projections. It is mounted at the tip of the colonoscope and held on by friction (pull-off force is a minimum of 10 Newtons).
16046253|NCT02552004|Device|pCLE|Histological examination by pCLE technique preceding the frozen section
16046254|NCT02552004|Drug|IV fluorescein administration|IV Fluorescein (fluorescent contrast agent) administration
16046255|NCT02551991|Drug|nal-IRI|
16046256|NCT02551991|Drug|5 fluorouracil|
16046257|NCT02551991|Drug|Leucovorin|
16046258|NCT02551991|Drug|Oxaliplatin|
16046259|NCT02551978|Other|The serious game KOP|The serious game transfers knowledge about nutrition (food pyramid, energy density of foods, which foods contribute to satiety and which not, energy in liquids, self-reflexive diagnostic tool to analyze daily food intake), physical activity (a motion-control to navigate through the game is partly used, relationship between energy expenditure and energy intake) and psychological aspects (relaxation-exercises, what is stress, stress-coping strategies).
16046260|NCT02551965|Other|Phone nursing follow-up|From the day of geriatric cancer patient's consultation, nurses will identify caregiver and will follow them by phone (caregiver) during 6 months
16046261|NCT02551952|Device|MentalPlus®|Validate the MentalPlus® digital game as neuropsychological test of cognitive assessment pre and postoperative on study the internal consistency and validity of content and construct (convergent) MentalPlus® of the evaluated patients. Study the influence of age, gender and level of education of surgical patients in performance for the use of electronic devices (laptop, tablet, mobile) and digital games. Investigate the rehabilitation capacity of cognitive functions after training sessions with MentalPlus® game. Evaluate the effect of training with MentalPlus® game in brain networks involved in executive function, memory and attention by means of fMRI this is a brain imaging study.
16046262|NCT02551939|Procedure|Autologous Fat Grafting|Autologous Fat Grafting
16046263|NCT02551926|Behavioral|mobile text messages|
16046264|NCT02551926|Behavioral|virtual community|
16046265|NCT02551926|Behavioral|brochures|
16046266|NCT02551926|Other|Usual care|
16046267|NCT02551926|Device|mobile phone|
16046268|NCT02551913|Behavioral|Control|the adolescents will not receive any specific intervention
16046269|NCT02551913|Behavioral|Intervention|A theory based sleep hygiene intervention based on the theory planned behavior will be conduced on the adolescent
16046270|NCT02551900|Other|Warm water exercise|Warm water based cycling exercise training program will be based on cycling in warm water (temperature 34◦C ). Warm water exercise will be conducted at moderate intensity (60-70% maximum heart rate). The three groups were exercise 15 minutes on the first month, second month will be increased to 20 minutes and the last month will be increased to 30 minutes. The training program will be performed 3 times per week for 12 weeks.
16046271|NCT02551900|Other|Cold water exercise|Cold water based cycling exercise training will be based on cycling in cold water (temperature 20◦C ). Cold water exercise will be conducted at moderate intensity (60-70% maximum heart rate). The three groups were exercise 15 minutes on the first month, second month will be increased to 20 minutes and the last month will be increased to 30 minutes. The training program will be performed 3 times per week for 12 weeks.
16046272|NCT02551900|Other|Land based cycling exercise|Land based cycling exercise training will be based on ride a bicycle ergometer (Monark 894e, Sweden). Land based cycling exercise training will be conducted at moderate intensity (60-70% maximum heart rate). The three groups were exercise 15 minutes on the first month, second month will be increased to 20 minutes and the last month will be increased to 30 minutes. The training program will be performed 3 times per week for 12 weeks.
16046273|NCT02551887|Behavioral|Automated Reminder|Automated reminder shown to provider
16046274|NCT02551887|Behavioral|Automated Reminder Plus Script|Provider sees both reminder and script.
16046275|NCT02551874|Drug|Saxagliptin, Onglyza|Tablets, Oral, 5mg , Once daily, 24 weeks
16046276|NCT02551874|Drug|Dapagliflozin, Farxiga|Tablets, Oral, 10mg , Once daily, 24 weeks
16046277|NCT02551874|Drug|Glargine insulin|100 Units/ml solution for injection in a prefilled SoloStar pen
16046278|NCT02551874|Drug|Metformin|Tablets, Oral, ≥ 1500mg/≤ 2500mg, Once daily, 24 weeks
16046279|NCT02551861|Drug|Daclatasvir|
16046280|NCT02551861|Drug|Sofosbuvir|
16046281|NCT02551861|Drug|Ribavirin|
16046282|NCT02551848|Drug|Botulinum toxin type A|
16046283|NCT02551822|Device|sacral neuromodulator|The Implanted Pulse Generator will be set via randomization to continuous vs cycling stimulation.
16046284|NCT02551809|Biological|UB-311|Intramuscular injection
16046285|NCT02551809|Drug|Placebo|Intramuscular injection
16046286|NCT02551796|Procedure|lenticule extraction|Four femtosecond incisions will be created in succession: the posterior surface of the refractive lenticule (spiral in), the lenticule border, the anterior surface of the refractive lenticule (spiral out), and the corneal flap in the superior region. After the suction is released, the flap will be opened using a thin, blunt spatula and the free refractive lenticule will be subsequently grasped with a forceps and extracted, after which the flap will be repositioned carefully.
16046407|NCT02550990|Behavioral|Cognitive training|
16046287|NCT02551796|Procedure|laser in situ keratomileusis|During LASIK surgery, the eye will be gently proptosed and a hinged corneal flap will be cut using a microkeratome. The flap will be lifted and the stromal bed will receive a 6 mm diameter and stroma ablation. Finally reposition the flap carefully.
16046288|NCT02551796|Procedure|FS assisted laser in situ keratomileusis|Track distance and spot distance will be 3.0 μm during flap creation and 1.5 μm during flap side-cutting. The flap diameter will be 8.0 mm, and flap thickness will be set to 105 μm. Side-cut angle and hinge angle will be 90°and 50° respectively. The flaps will be created by laser scanning in spirals from the periphery to the center of the pupil. An excimer laser system will be used in the subsequent ablation of thstromal bed with a 6.0 mm optical zone. Once the excimer. ablation is completed, the flap will be repositioned in a similar fashion as in routine LASIK.
16046289|NCT02551783|Procedure|Urethroplasty with buccal mucosa graft|A surgery to correct urethral stricture
16046290|NCT02551783|Procedure|Ventral Buccal|Urethroplasty with buccal graft. In this arm the graft is placed on the ventral wall of the urethra.
16046291|NCT02551770|Procedure|Scaling and root planing|Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw.
16046292|NCT02551770|Procedure|Scaling and root planing without Emdogain|Using minimally invasive surgical procedure (scaling and root planing) without Emdogain application to treat one contra-lateral quadrant in subject's jaw.
16046293|NCT02551770|Device|Emdogain application|Using minimally invasive surgical procedure (scaling and root planing) with Emdogain application to treat one contra-lateral quadrant in subject's jaw
16046294|NCT02551757|Device|Auto-titrating CPAP|Auto-titrating CPAP was initiated after admission to the inpatient rehabilitation unit for the duration of rehabilitation but not exceeding 28 days. A respiratory therapist visited patients nightly to document adherence and address issues arising at night. A sleep technologist also met with patients at least twice weekly to monitor safety and adverse events and make any adjustments to the CPAP mask or machine. Efforts to improve adherence to CPAP for patients treated with active-CPAP included patient education, desensitization of CPAP through brief periods of daytime use, adjustments of humidity and mask (including addition of a chin strap), decreasing CPAP maximum pressure and use of expiratory pressure relief (CFlex) for patients treated with active-CPAP.
16046295|NCT02551757|Device|Sham-CPAP|Sham-CPAP was initiated after admission to the inpatient rehabilitation unit for the duration of rehabilitation but not exceeding 28 days. A respiratory therapist visited patients nightly to document adherence and address issues arising at night. A sleep technologist also met with patients at least twice weekly to monitor safety and adverse events and make any adjustments to the CPAP mask or machine. Efforts to improve adherence to CPAP for patients treated with sham-CPAP included patient education, desensitization of CPAP through brief periods of daytime use and adjustments of humidity and mask, including addition of a chin strap.
16046296|NCT02551744|Drug|histamine-2 receptor antagonist group|famotidine tab 40 mg qd for 6 months.
16046297|NCT02551744|Drug|proton pump inhibitor group|pantoprazole tab 40 mg qd for 6 months.
16046298|NCT02551731|Drug|Cannabidiol Oral Solution|20 or 40 mg/kg/day BID
16046299|NCT02551718|Other|Chemosensitivity Assay|Lab test in which leukemia cells obtained from blood or bone marrow are tested for sensitivity to 115 drugs individually and in certain combinations
16046300|NCT02551718|Other|Cytology Specimen Collection Procedure|Undergo blood or bone marrow collection
16046301|NCT02551718|Genetic|Gene Expression Analysis|Analysis of leukemia cell genes to identify possible drug targets
16046302|NCT02551718|Genetic|Genetic Variation Analysis|Analysis of leukemia cell genes to identify possible drug targets
16046303|NCT02551718|Drug|In Vitro Sensitivity-Directed Chemotherapy|"Receive personalized chemotherapy with one or more of the following drugs:
~Afatinib Arsenic trioxide Axitinib Azacitidine Bexarotene Bortezomib Bosutinib Busulfan Cabazitaxel Cabozantinib Carfilzomib Ceritinib Cladribine Clofarabine Crizotinib Cytarabine HCl Dabrafenib Dasatinib Daunorubicin HCl Decitabine Erlotinib Etoposide Everolimus Fludarabine Gefitinib Gemcitabine HCl Hydroxyurea Imatinib Irinotecan Lapatinib Lomustine Melphalan Mercaptopurine Methotrexate Mitoxantrone Nelarabine Nilotinib Paclitaxel Pazopanib Pentostatin Ponatinib Pralatrexate Rapamycin Regorafenib Romidepsin Ruxolitinib Sorafenib Sunitinib Temsirolimus Thioguanine Topotecan HCl Trametinib Tretinoin"
16046304|NCT02551705|Other|functional Imaging|Brain responses associated with emotional memory will be investigated
16046305|NCT02551692|Drug|Nicotine Patch|Participants will wear 21mg/day patches for days 1-14. After day 14, participants will make a quit attempt continue to wear the 21mg/d patches for 6 weeks, then step down to 14mg/d patches for 2 weeks and finally step down 7mg/d for the last 2 weeks of treatment. Participants will also take a placebo capsule. During days 8-14, participants will undergo 2 cue-exposure sessions.
16046306|NCT02551692|Drug|Varenicline|Varenicline (VAR) will be administered by titrating to steady state levels over a 7 day induction period (.5 mg once daily in Days 1-3; .5 mg twice daily on Days 4-7 and 1 mg twice daily on Days 8-14). Participants will continue on 1mg twice daily until the end of treatment (days 15-84). Participants will also wear a placebo patch. During days 8-14, participants will undergo 2 cue-exposure sessions.
16046307|NCT02551692|Drug|Placebo Nicotine Patch|"In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions.
~In the VAR group, participants will wear a placebo patch while taking varenicline."
16046308|NCT02551692|Drug|Placebo Capsule|"In the PLAC group, participants will receive placebo patches and placebo capsules for 14 days prior to quitting smoking. They will then switch to wearing a nicotine patch the morning of their quit day in order to provide them with the minimum standard of care. During days 8-14, participants will undergo 2 cue-exposure sessions.
~In the NRT group, participants will take a placebo capsule while wearing nicotine patches."
16046309|NCT02551679|Biological|ACP-01|Injection into lower extremity
16046310|NCT02551679|Biological|Placebo|Injection into lower extremity
16046311|NCT02551666|Other|Balance recovery training|Participants will practice recovering their balance after a perturbation similar to tripping while walking. Each of these 'balance recovery training' sessions will last approximately 30 minutes, and will be performed 3 times per week for 4 weeks.
16046408|NCT02550990|Behavioral|Aerobic exercise training|
16046312|NCT02551666|Other|Tai Chi exercise|Participants will perform Tai Chi exercises (Yang short form) for 30 minutes, 3 times a week for 4 weeks. Each session will be led by an experienced Tai Chi instructor.
16046313|NCT02551653|Drug|[11C]-GSK2256098 500 MBq|[11C]-GSK2256098 injection will be provided as IV infusion, 20 mL, containing up to 5% ethanol in saline.
16046314|NCT02551640|Other|FeatForward App (on study smartphone)|"The FeatForward mobile app will have the following features:
~Messaging: Educational messages tailored to user's medical conditions and motivational messages tailored to user's stage of change.
~Tracking: Ability to track physical activity, weight, blood pressure, blood glucose and heart rate.
~Community: Users in later stages of change able to encourage and motivate one another through groups.
~Educational Library: To provide educational tips and health information. Provider Engagement: Ability for physicians to view patient data, and send messages to patients.
~Monthly depression assessments: The app will prompt users to complete a monthly voluntary depression assessment.
~Social Support: Those using the FeatForward app will also have access to a Facebook group."
16046315|NCT02551627|Dietary Supplement|Test Product|MMN fortified beverage powder.
16046316|NCT02551627|Dietary Supplement|Control|Isocaloric beverage powder without micronutrient fortification.
16046317|NCT02551614|Procedure|Lipopolysaccharide challenge|Lipopolysaccharide solution inhaled using a dosimeter.
16046318|NCT02551614|Procedure|Saline challenge|0.9% sodium chloride solution inhaled using dosimeter.
16046319|NCT02551614|Procedure|Labelled neutrophils and Imaging assessment|Injection of labelled neutrophils and imaging assessments
16046320|NCT02551601|Other|measure subfoveal choroidal thickness|measure subfoveal choroidal thickness using optical coherence tomography
16046321|NCT02551588|Procedure|Valvular aortic stenosis surgery|Dilatation of Valvular aortic stenosis
16046322|NCT02551575|Drug|Treatment of MTX and HCQ|"Methotrexate: 10-15mg per week according to patient's weight, oral, for 24 weeks.
~Hydroxychloroquine: 200mg, 2 times a day, oral, for 24 weeks. Qingre Huoxue granule placebo: 10g, 2 times a day, oral, for 24 weeks. Qingre Huoxue external preparation placebo: 20g, 1 times a day, external, for 4 weeks, then 10g, 1 times a day, external, for 8 weeks."
16046323|NCT02551575|Drug|Treatment of TCM|"Qingre Huoxue granule: 10g, 2 times a day, oral, for 24 weeks. Qingre Huoxue external preparation: 20g, 1 times a day, external, for 4 weeks, then 10g, 1 times a day, external, for 8 weeks.
~Methotrexate placebo: 10-15mg per week according to patient's weight, oral, for 24 weeks.
~Hydroxychloroquine placebo: 200mg, 3 times a day, oral, for 24 weeks."
16046324|NCT02551575|Drug|Integrative Medicine|"Qingre Huoxue granule: 10g, 2 times a day, oral, for 24 weeks. Qingre Huoxue external preparation: 20g, 1 times a day, external, for 4 weeks, then 10g, 1 times a day, external, for 8 weeks.
~Methotrexate: 10-15mg per week according to patient's weight, oral, for 24 weeks.
~Hydroxychloroquine: 200mg, 3 times a day, oral, for 24 weeks."
16046325|NCT02551562|Other|NuDerm® System|The Nu-Derm® System (Valeant Pharmaceuticals North America, LLP) is a skin care system that helps correct and reduce visible signs of aging such as age spots, rough skin, erythema, sallowness, and hyperpigmentation.
16046326|NCT02551562|Other|Placebo|Basic skin care regimen
16046327|NCT02551549|Drug|CD101 IV|antifungal
16046328|NCT02551549|Drug|Placebo|Normal saline
16046329|NCT02551536|Drug|Montelukast|
16046330|NCT02551536|Drug|Fexofenadine|group B received FDC tablet of montelukast 10mg and fexofenadine 120 mg O.D
16046331|NCT02551536|Drug|Levocetrizine|group A recieved FDC tablet of montelukast 10 mg and levocetrizine 5mg O.D
16046332|NCT02551523|Drug|Dolutegravir|92 patients will be simplified to once daily dolutegravir monotherapy
16046333|NCT02551523|Drug|Standard of care combinational antiretroviral therapy|
16046334|NCT02551510|Procedure|Suture|Skin incision closure with standard subcuticular technique
16046335|NCT02551510|Device|Experimental: Histoacryl®|Skin incision closure with topic skin adhesive Histoacryl® Flexible (n-Butyl-2-Cyanoacrylate Monomer)
16046336|NCT02551497|Drug|CNV1014802|
16046337|NCT02551484|Device|Measurements using NIRS|
16046338|NCT02551484|Device|TCPO2 measurements|
16046339|NCT02551484|Other|2-minute walk test|
16046340|NCT02551471|Other|Blinded inter-country reading of pelvic MRI (Magnetic Resonance Imaging)|"This experiment will consist of an inter-country reading of patients' pelvic MRIs, blind to the other country's decision. The MRI shared will be the one based on which the treatment decision will be made. In case of medical contraindication to perform pelvic MRI, the scan will be used to assess the care-decision concordance between both countries."
16046341|NCT02551471|Other|MDT (Multidisciplinary team) meeting observation|"3 per centre with real patient cases and theoretical patient cases (blinded pelvic MRI re-reading)."
16046342|NCT02551471|Other|Semi-structured exploratory interviews and focus group with MDT health professional attendees|Will identify care management systems for PRC-bTME and LRRC patients, explore social representations that direct the formulation of a therapeutic decisions and identify cultural, medical and personal factors
16046343|NCT02551458|Other|Systematic surgery|
16046344|NCT02551458|Other|Surveillance and rescue surgery in cases of resectable loco-regional recurrence|
16046345|NCT02551445|Behavioral|Gradual exposure to food stimuli|Patients with anorexia nervosa will be encouraged to confront their fears and avoidance in relation to food and will be gradually exposed to different food items during the sessions.
16046346|NCT02551432|Drug|pembrolizumab, paclitaxel|pembrolizumab, paclitaxel
16046347|NCT02551419|Dietary Supplement|ketogenic drink|6 months' supplementation with the ketogenic drink . Product will be taken daily - 125 ml will be consumed at the morning meal, and 125 ml at the evening meal.
16046348|NCT02551419|Dietary Supplement|placebo|6 months' supplementation with the placebo drink . Product will be taken daily - 125 ml will be consumed at the morning meal, and 125 ml at the
16046349|NCT02551406|Device|Capno-oxymetry monitoring|Monitoring of home mechanical ventilation by capno-oximetry
16046409|NCT02550990|Behavioral|Sequential combination of aerobic exercise and cognitive training|
16046410|NCT02550977|Drug|Gestodene/EE Patch (BAY86-5016)|7 day patch containing 0.55 mg ethinyl estradiol and 2.1 gestodene in a 21 day regimen.
16046449|NCT02550652|Drug|Obinutuzumab|Obinutuzumab will be administered as per schedule specified in the respective arm.
16046450|NCT02550652|Other|Placebo|Placebo matching to obinutuzumab will be administered as per schedule specified in the respective arm.
16046350|NCT02551393|Behavioral|Home Blood Presssure Monitoring, Education|Doctors and Nurses in intervention clinic will receive 1 hour briefing + education on the background, scientific basis and detail of the program during lunch time. People from intervention clinics will be invited to attend 2 x 2 hours education group (15-30 subjects / group) ran by clinic nurses and doctors. You will be educated on basic knowledge, management and drug for hypertension in the first session. In the 2nd session, a certified valid Home BP device will be loaned to you for 6-9 months and you will be taught to perform home BP monitoring, record and response to the BP reading accordingly. Upon completion of session 2, you will be arranged for nurse individual follow up after 4-8 weeks to see their progress and monitoring
16046351|NCT02551380|Drug|FOLINORAL|Folinoral (folinic acid) 5mg twice a day (10 mg per day) during 12 weeks
16046352|NCT02551380|Other|Placebo|Placebo 5mg twice a day (10 mg per day) during 12 weeks
16046353|NCT02551367|Drug|Letrozole|2.5 mg will taken from day 2 to day 6 of the cycle , for 3 consecutive cycles
16046354|NCT02551367|Drug|Clomiphene citrate|50 mg twice daily orally from day 2 to day 6 , for 3 consecutive cycles
16046355|NCT02551367|Drug|hcg hormone|10.000 iu im injection when follicle diameter reach 18 mm by transvaginal ultrasound
16046356|NCT02551354|Device|Portable video pupillometer|Portable video pupillometer measures pupil diameter (PD) in patient during obstetrical labor
16046357|NCT02551341|Procedure|higher PEEP ventilation|
16046358|NCT02551328|Drug|sevofluorane|Continuous infusion of sevofluorane
16046359|NCT02551302|Device|Solera™ Medtronic|The control group will receive a monosegmental posterior lumbar spine fusion with an intervertebral cage (PLIF). Solera™ Medtronic
16046360|NCT02551302|Device|CD HORIZON BalanC™ Medtronic|"The intervention group will receive a hybrid system with a PLIF and a flexible pedicle screw system above the fusion. Surgery will be performed with the following devices:
~CD HORIZON BalanC™ Medtronic"
16046361|NCT02551289|Other|Gluten free diet|Patients will follow a gluten free diet
16046362|NCT02551276|Drug|Salbutamol|
16046363|NCT02551276|Drug|Placebo|
16046364|NCT02551276|Other|Resistance training|
16046365|NCT02551263|Drug|Eribulin|Eribulin 1.4 mg/m2 will be administered intravenously over 2 to 5 minutes on day 1 and 8 of every 21-day cycle, in a real-world setting.
16046366|NCT02551250|Device|annual noncontrast MRI|liver MRI without contrast agents T2 weighted image, T1 in/out of phase, diffusion weighted images with b-values of 0, 500 mm2/s
16046367|NCT02551250|Device|biannual ultrasonography|liver ultrasonography for HCC screening performed by experienced sonologists
16046368|NCT02551237|Radiation|50 Gy|radiotherapy 50 Gy in 25 fractions of 2 Gy, five times per week, over a period of 5 weeks
16046369|NCT02551237|Drug|Capecitabine|oral capecitabine 800 mg/m2 twice daily from the first day of radiotherapy and given 5 days per week during radiotherapy.
16046370|NCT02551237|Radiation|25 Gy|radiotherapy 25 Gy in 5 fractions of 5 Gy delivered in one week (short-course arm)
16046371|NCT02551224|Other|Patient preference questionnaire|The primary variable will be the mean score of questions 1(a) to 1(c) from the preference questionnaire completed at the end of study.
16046372|NCT02551211|Procedure|blood drawn|blood drawn
16046373|NCT02551211|Procedure|surgical resection of cancer|
16046374|NCT02551198|Drug|HAPREP®|"Arm1: HAPREP® (2L polyethylene glycol with ascorbic acid; PEG-Asc)
~: : PEG-Asc(500mLx2 times q30min)[PM 7-9, the day before colonoscopy] + PEG-Asc(500mLx2 times q30min)[AM 5-7, the day of colonoscopy]"
16046375|NCT02551198|Drug|SUCLEAR®|Arm2: SUCLEAR® (oral sulfate solution; OSS): OSS(1b/177mL)[PM 7-9, the day before colonoscopy] + OSS(1b/177mL)[AM 5-7, the day of colonoscopy]
16046376|NCT02551185|Drug|ACY-241|
16046377|NCT02551172|Drug|HCP1105|Rosuvastatin + Omega-3-acids ethyl esters
16046378|NCT02551172|Drug|HGP0816|Rosuvastatin
16046379|NCT02551172|Drug|Placebo of HCP1105|Soybean Oil
16046380|NCT02551172|Drug|Placebo of HGP0816|Exclusion of Rosuvastatin in HGP0816
16046381|NCT02551159|Biological|MEDI4736|Anti-PD-L1 antibody
16046382|NCT02551159|Biological|Tremelimumab|Anti-CTLA-4 Antibody
16046383|NCT02551159|Biological|MEDI4736+Tremelimumab|
16046384|NCT02551159|Biological|Cetuximab|Monoclonal Antibody
16046385|NCT02551159|Drug|5-fluorouracil (5FU)|Chemotherapy Agent
16046386|NCT02551159|Drug|Cisplatin|Chemotherapy agent
16046387|NCT02551159|Drug|Carboplatin|Chemotherapy Agent
16046388|NCT02551146|Device|A Locator with retention elements|Insertion of GC Pilier locator abutments with retention elements
16046389|NCT02551146|Device|B Locator without retention elements|Insertion of GC Pilier locator abutments without retention elements
16046390|NCT02551133|Drug|dexamethasone|1 hour before surgery
16046391|NCT02551107|Device|Measurement of nasal Nitric Oxide level|ECO MEDICS CLD 88 sp Nitric Oxide Analyzer
16046392|NCT02551094|Drug|colchicine|0.5 mg tablet taken once a day
16046393|NCT02551094|Drug|colchicine placebo|sugar pill manufactured to mimic colchicine 0.5 mg tablet
16046394|NCT02551068|Other|60% Oxygen|While participants are exercising, they will be inhaling 60% oxygen through a mask
16046395|NCT02551068|Other|Standard of Care|While participants are exercising, they will be breathing air through a mask that will be titrated to keep oxygen saturation at least 88%, allowing a maximum inhaled oxygen percentage of 40%.
16046396|NCT02551055|Drug|MLN1117|MLN1117 Tablets
16046397|NCT02551055|Drug|TAK-659|TAK-659 Tablets
16046398|NCT02551055|Drug|Alisertib|Alisertib Tablets
16046399|NCT02551055|Drug|Paclitaxel|Paclitaxel intravenous infusion
16046400|NCT02551055|Drug|Docetaxel|Docetaxel intravenous infusion
16046401|NCT02551042|Drug|Fibrogammin®P, coagulation factor XIII concentrate (Human)|IV infusion
16046402|NCT02551042|Drug|0.9% sodium chloride|IV infusion
16046403|NCT02551029|Other|Capsaicin|
16046404|NCT02551029|Other|Placebo|
16046405|NCT02551003|Drug|Autologous cord blood|Autologous cord blood will be collected after birth and administered in divided aliquots during the first 3 days of life. At the same time, babies will referred to neonatal intensive care unit for hypothermia therapy of cooling to 33.5 ℃ body temperature for 72 hours and standard intensive care.
16046406|NCT02551003|Device|Hypothermia|Hypothermia therapy of cooling to 33.5 ℃ body temperature for 72 hours and standard intensive care.
16046411|NCT02550964|Procedure|Composite Examination|First, patients will get the baseline ophthalmologic exam and medical evaluation by physicians. As a diagnostic method, the composite examination including fundus photography, fundus autofluorescence, spectral-domain optical coherence tomography, Humphrey visual field test and multifocal electroretinography will be tested once every year.
16046412|NCT02550951|Procedure|lymphangiography|
16046413|NCT02550938|Device|Invisalign|The Invisalign® System consists of a series of clear plastic aligners that are intended to replace conventional wire and bracket technology for many orthodontic cases. Each custom manufactured aligner exerts gentle, continuous forces to move teeth incrementally from their original state to a final, treated state. Each aligner is worn for a defined period of time , then replaced by the next in the series until the final position is achieved. For years, orthodontists and dentists have used removable appliances for orthodontic treatment. Today, with the application of computer technology and custom manufacturing, Invisalign treats a broader range of cases with greater precision.
16046414|NCT02550925|Behavioral|Acceptance and Commitment Therapy (ACT) Group|A 7-session Acceptance and Commitment Therapy (ACT) group intervention
16046415|NCT02550925|Behavioral|Usual Care|Check in with clinical social worker at oncology care site and obtain list of supportive resources
16046416|NCT02550912|Drug|Vitamin D3|vitamin D drops for paediatrics
16046417|NCT02550912|Other|Placebo|glucose syrup with same taste and color to vitamin D3 drops
16046418|NCT02550899|Procedure|Transanal submucosal injection group 1|Transanal submucosal injection using an anoscope using four sites circumferentially above the dentate line at 12, 3, 6 and 9 o'clock using 4 ml polyacrylamide
16046419|NCT02550899|Procedure|Transanal submucosal injection group 2|Transanal submucosal injection using an anoscope using three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 4 ml polyacrylamide
16046420|NCT02550899|Procedure|Transanal submucosal injection group 3|Transanal submucosal injection using an anoscope using three sites circumferentially above the dentate line at 12, 4 and 8 o'clock using 6 ml polyacrylamide
16046421|NCT02550886|Other|Survey|Patients and their caregivers will be asked to complete surveys about their expected and actual time taken off from work. They will also answer questions about the patient's recovery, as well as the patient/caregiver relationship.
16046422|NCT02550873|Biological|PRM-151|PRM 151 10 mg/kg IV infusion over 60 minutes days 1, 3, and 5, then one infusion every 4 weeks
16046423|NCT02550873|Other|placebo|Placebo IV infusion over 60 minutes on days 1, 3, and 5, then one infusion every 4 weeks
16046424|NCT02550860|Drug|soybean oil (SO)-based IVFE (Medialipide)|The soybean oil (SO)-based IVFE will be allocated for a 3-month period, allowing sufficient timeframe for epidermal complete renewal.
16046425|NCT02550860|Drug|fish oil (FO)-containing IVFE (Lipidem)|The fish oil (FO)-containing IVFE will be allocated for a 3-month period, allowing sufficient timeframe for epidermal complete renewal.
16046426|NCT02550847|Device|The imaging biomarkers determined by MR-PET|The aim of this study was to evaluate MR/PET with both functional and molecular imaging on the prediction of prognosis in patients with suspected pancreatic cancer.
16046427|NCT02550834|Other|Wheelchair indoors curling training|8x 90 minutes of training and playing indoors curling in 4 weeks
16046428|NCT02550795|Drug|Dexmedetomidine|administration of dexmedetomidine only
16046429|NCT02550795|Drug|Dexmedetomidine and dexamethasone|administration of dexmedetomidine and dexamethasone
16046430|NCT02550795|Drug|Control|administration of normal saline
16046431|NCT02550782|Drug|Bupivacaine|patient- controlled infraclavicular perineural marcaine infusion
16046432|NCT02550782|Drug|Dexmedetomidine|patient- controlled infraclavicular perineural marcaine with dexmedetomidine infusion
16046433|NCT02550769|Procedure|TRANSANAL TOTAL MESORECTAL EXCISION|The technique begins with the TEO equipment and a purse string 1 cm distal to the tumor. The dissection progresses in the posterior part until the laparoscopic TME field is reached. After the section of the rectum and TME transanal dissection, the anvil of the circular mechanical stapler is introduced through the TEO rectoscope. In the laparoscopic field, the mesosigma is sectioned at the point where the colon section is to be performed. The TEO rectoscope is withdrawn, and the bag containing the specimen is removed through the anus. The stapler is inserted. From the laparoscopic field, the strings of the purse are tightened and the purse is closed around the rectal stump with a clip. Then the stapler are joined to perform the anastomosis and a loop ileostomy is placed in the right flank.
16046434|NCT02550769|Procedure|Laparoscopic-LAR|Standard laparoscopic low anterior resection of the rectum with total mesorectal excision and colorectal anastomosis
16046435|NCT02550756|Drug|CTNX-4975|
16046436|NCT02550743|Drug|BYL719|
16046437|NCT02550743|Drug|Capecitabine|
16046438|NCT02550743|Radiation|Radiation|
16046439|NCT02550730|Behavioral|Birth Sisters Best Beginnings for Babies|Birth Sisters Best Beginnings for Babies support during Pregnancy, Labor and Delivery and six weeks postpartum. Participants assigned to the Birth Sister group receive community doula services with consultation from the Medical Legal Partnership when indicated beginning at 24 weeks. Participants receive up to 8 two-hour prenatal home visits; continuous support through labor and birth, and up to 4 two-hour postpartum home visits through 6-8 weeks postpartum.
16046440|NCT02550730|Other|Usual maternity care|Usual prenatal, intrapartum and postpartum maternity care
16046441|NCT02550717|Drug|Acetylsalicylic Acid (Aspirin, BAYE4465)|Low-dose ASA for secondary prevention of cardiovascular events
16046442|NCT02550717|Drug|Clopidogrel, Oral Anticoagulants, NSAIDs and SSRIs|Secondary prevention of cardiovascular events
16046443|NCT02550704|Procedure|Colonoscopy with eleven biopsies in the left colon to assess intestinal permeability|Eleven colonic biopsies are taken in the left colon during colonoscopy. Intestinal permeability is assessed by western blot, qPCR and immunofluorescence for claudin, occludin and ZO-1.
16046444|NCT02550691|Procedure|blood sampling|A blood sample will be taken on subject carrying specific genotype
16046445|NCT02550678|Biological|ASN-002|ASN-002, is made of a suspension of recombinant adenoviral particles carrying a gene coding for the human interferon-gamma (IFN). Study participants will receive protocol defined dose of ASN-002 as intra-tumoral injections.
16046446|NCT02550678|Drug|5-FU|5-FU is chemotherapeutic agent used to treat various cancers.
16046447|NCT02550665|Drug|donepezil|using different titration method for the first 4 weeks, and after the 4 weeks, 23mg/day orally
16046451|NCT02550652|Drug|Methylprednisolone|Methylprednisolone IV will be administered as per schedule specified in the respective arm.
16046452|NCT02550652|Drug|Prednisone|Prednisone will be administered as per schedule specified in the respective arm.
16046453|NCT02550639|Other|BIOMARKER- elispot test|ELISPOT TEST
16046454|NCT02550613|Device|The imaging biomarkers determined by MR-PET|The purpose of this study is to explore the ability of integrated MRI/PET to detect and evaluate treatment outcome in HCC patients. This study using 18F-FDG PET and functional MRI (DCE-MRI, Diffusion-weighted MRI, MR spectroscopy).
16046455|NCT02550600|Procedure|iLA activve treatment|"iLA activve is aimed at efficient extracorporeal membrane oxygenation with an initial blood flow of ≥2L/min. The length of therapy is at the discretion of the treating physician.
~Treating physicians are recommended to use a pre-specified algorithm to optimize the extracorporeal lung assist (choice of cannulas and oxygenator, titration of blood flow and sweep gas flow). Primary/mandatory goals are pO2≥65mmHg, P_peak ≤30cm H2O, TV ≤6ml/kg PBW and pH ≥7.25. Secondary suggested goals are setting the PEEP level within the limits suggested by the ARDSnet low and high PEEP strategy, 35mmHg ≤ pCO2 ≤45mmHg, Delta-pressure (= P_peak - PEEP) ≤15 cm H2O and P_peak ≤25 cm H2O.
~iLA activve treatment also requires anticoagulation with un-fractionized heparin (PTT-goal 45s-60s depending on blood flow)."
16046456|NCT02550600|Procedure|Control group|"The controls will be treated according to the recent guideline of the German Sepsis Society and the German Interdisciplinary Association of Intensive Care and Emergency Medicine and good clinical practice including lung-protective ventilation with low tidal volume (LTV), moderate hypercapnia, PEEP according to ARDSnet, adjunctive measures (e.g. prone positioning; neuromuscular blockers as appropriate) and treatment of the underlying disease as applied in the experimental group.
~There will be no sham treatment of iLA activve.in the controls. All adjunctive measures (e.g. prone positioning; neuromuscular blockers as appropriate) are also available for the intervention group."
16046457|NCT02550587|Behavioral|satisfaction|anesthesia satisfaction rates
16046458|NCT02550574|Procedure|Wound Closure with 2-octylcyanoacrylate|
16046459|NCT02550574|Procedure|Wound Closure with 5-0 Vicryl Sutures|
16046460|NCT02550561|Device|Posterior Tibial Nerve Stimulation|PTNS (under the brand name Urgent PC) is an FDA-approved device for the treatment of urinary urgency, urinary frequency and urge incontinence. It is often described as a peripheral form of neuromodulation (as opposed to SNM which is central neuromodulation at the level of the nerve root). PTNS involves 12 weeks of weekly 30 minute office-based treatment sessions with a small electrode placed slightly above the ankle in order to stimulate the S2-4 nerve roots.
16046461|NCT02550548|Drug|GIP infusion|after establishing a hyperglycemic clamp (target: 125 mg/dL) GIP will be infused
16046462|NCT02550548|Drug|GLP-1 infusion|after establishing a hyperglycemic clamp (target: 125 mg/dL) GLP-1 will be infused
16046463|NCT02550548|Drug|Ex-9 infusion|Ex-9 infusion will be initiated at start of hyperglycemic clamp (target: 125 mg/dL)
16046464|NCT02550535|Genetic|Autologous WT1 TCR transduced T cells|Gene therapy: Autologous WT1 TCR transduced T cells administered by intravenous infusion
16046466|NCT02550509|Device|ultrasound echogenicity|ultrasound echogenicity to patient with stroke
16046467|NCT02550509|Device|elastography|elastography to patient with stoke
16046468|NCT02550496|Device|Dermoscopy|
16046469|NCT02550483|Other|Base diet + high beta-carotene tomato juice|Participants will receive high beta-carotene tomato juice daily in addition to the base diet. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. The base diet will be low in betacarotene and lycopene (no carrots, sweet potato, tomatoes, and dark greens). During the controlled diet period, participants will be instructed to eat all foods and only foods provided to them, with the exception of water, coffee, tea, and diet soda.
16046470|NCT02550483|Other|Base diet + high lycopene tomato juice|Participants will receive high lycopene tomato juice daily in addition to the base diet. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. The base diet will be low in betacarotene and lycopene (no carrots, sweet potato, tomatoes, and dark greens). During the controlled diet period, participants will be instructed to eat all foods and only foods provided to them, with the exception of water, coffee, tea, and diet soda.
16046471|NCT02550483|Other|Base diet + placebo beverage|Participants will receive a placebo beverage daily in addition to the base diet. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. The base diet will be low in betacarotene and lycopene (no carrots, sweet potato, tomatoes, and dark greens). During the controlled diet period, participants will be instructed to eat all foods and only foods provided to them, with the exception of water, coffee, tea, and diet soda.
16046472|NCT02550470|Device|Carbon Dioxide Absorbents|lithium hydroxide was studied for use in anesthesia as a possible replacement for calcium absorbents. This agent has been used for CO2 absorption in the military and in aerospace for over 50 years due to its high capacity and efficiency in the removal of CO2. It was however not considered usable by the medical industry due to concerns with its granular form. It has now been demonstrated that LiOH does not interact with commonly used inhalation anesthetic agents and appears to have higher CO2 removal capability.7,8
16046473|NCT02550470|Device|Micropore SpiraLith|lithium hydroxide was studied for use in anesthesia as a possible replacement for calcium absorbents. This agent has been used for CO2 absorption in the military and in aerospace for over 50 years due to its high capacity and efficiency in the removal of CO2. It was however not considered usable by the medical industry due to concerns with its granular form. It has now been demonstrated that LiOH does not interact with commonly used inhalation anesthetic agents and appears to have higher CO2 removal capability.
16046474|NCT02550470|Drug|Sevoflurane|
16046475|NCT02550457|Other|Functional elastic tape tensioned|Application of Kinesio Taping with tension in the erector spine muscles.
16046476|NCT02550457|Other|Functional elastic tape non-tensioned|Application of Kinesio Taping without tension in the erector spine muscles.
16046477|NCT02550457|Other|Rigid Tape|Application of Micropore tape in the erector spine muscles.
16046478|NCT02550444|Drug|Intrathecal Clonidine|Intrathecal Adjuvant Clonidine 75 mcg; Intravenous Placebo (Saline 0,9%); Intrathecal heavy Bupivacaine 0,5% (15mg), morphine 0,02 (80mcg) and fentanyl (10mcg).
16046479|NCT02550444|Drug|Intravenous Clonidine|Intravenous Clonidine 75 mcg; Intrathecal Placebo (Saline 0,9%); Intrathecal heavy Bupivacaine 0,5% (15mg), morphine 0,02 (80mcg) and fentanyl (10mcg).
16046480|NCT02550444|Drug|Placebo|Intravenous and intrathecal Placebo (Saline 0,9%); Intrathecal heavy Bupivacaine 0,5% (15mg), morphine 0,02 (80mcg) and fentanyl (10mcg).
16046481|NCT02550418|Drug|Budesonide|
16046482|NCT02550405|Behavioral|Craving behavioral intervention|The CBI was given once a week for 6 weeks, conducted by four therapists. A pair of therapists was randomly assigned to a CBI+ group. Each session included 5 parts in 2.5-3 hours: warming-up exercise, discussion about the homework from the last session, main structured activity, brief summary, and the homework assignment. There were 6 sessions with each focused on a topic: recognize craving and its relationship with IGD; reduce craving through ameliorating the salience of cues and irrational beliefs, withdrawal symptoms and other negative affects; enhance self-monitoring and control for craving through time management training; relieve fulﬁllment of psychological needs through Internet use and attenuate the relation between craving and gaming behaviors through coping skill training
16046483|NCT02550392|Behavioral|Psychoeducation|A time-limited group psychoeducational intervention that will aim to offer educational, psychological and social support.
16046484|NCT02550379|Behavioral|Intervention|Emotion Recognition Training
16046485|NCT02550379|Other|Placebo|Placebo Training
16046486|NCT02550366|Drug|MRI Contrast|MRI Contrast
16046487|NCT02550353|Procedure|lenticule extraction|Four femtosecond incisions were created in succession: the posterior surface of the refractive lenticule (spiral in), the lenticule border, the anterior surface of the refractive lenticule (spiral out), and the corneal flap in the superior region. After the suction was released, the flap was opened using a thin, blunt spatula and the free refractive lenticule was subsequently grasped with a forceps and extracted, after which the flap was repositioned carefully.
16046488|NCT02550353|Procedure|femtosecond laser-assisted laser in situ keratomileusis|track distance and spot distance were 3.0 μm during flap creation and 1.5 μm during flap side-cutting. The flap diameter was 8.0 mm, and flap thickness was set to 105 μm. Side-cut angle and hinge angle were 90°and 50° respectively. The flaps were created by laser scanning in spirals from the periphery to the center of the pupil. An excimer laser system was used in the subsequent ablation of the stromal bed with a 6.0 mm optical zone. Once the excimer ablation was completed, the flap was repositioned in a similar fashion as in routine LASIK.
16046489|NCT02550340|Other|acute alcohol intake|Smart phone based ECG recording
16046490|NCT02550327|Drug|Nab-paclitaxel|125 mg/m2
16046491|NCT02550327|Drug|Gemcitabine|1000 mg/m2
16046492|NCT02550327|Drug|Cisplatin|25 mg/m2
16046493|NCT02550327|Drug|Anakinra|100 mg
16046494|NCT02550314|Drug|fiblast,gelatin sponge,fibrin glue|
16046495|NCT02550301|Other|Mean Platelet Volume|Ten milliliters (mls) of blood will be drawn from eligible, consented patients at the time of the admission, collected in ethylenediamine tetraacetic acid (EDTA) tubes, and tested for CBC. Platelets have an average life span that can vary from 8-10 days or 10-36 days. To minimize this bias, three additional MPV samples will be collected on day 1, day 7 and day 30 post PCI.
16046496|NCT02550288|Drug|Ezetimibe 10 mg|
16046497|NCT02550288|Drug|Atorvastatin 10 mg|
16046498|NCT02550288|Drug|Placebo for Ezetimibe 10 mg tablet|
16046499|NCT02550288|Drug|Placebo for Atorvastatin 10 mg capsule|
16046500|NCT02550288|Behavioral|Diet control/Daily Exercise|Diet and Daily exercise program as per Japan Atherosclerosis Society Guideline 2012 (JAS2012)
16046501|NCT02550275|Behavioral|neuropsychological test|
16046502|NCT02550275|Radiation|MRI|
16046503|NCT02550262|Drug|Bupivacaine|0.0625% Bupivacaine plus fentanyl 2mcg/ml
16046504|NCT02550262|Drug|Fentanyl|0.0625% Bupivacaine plus fentanyl 2mcg/ml
16046505|NCT02550262|Device|Infusion pump|Infusion pump set to deliver programmed intermittent epidural boluses (PIEB) plus patient-controlled epidural analgesia (PCEA).
16046506|NCT02550249|Drug|Nivolumab|Intravenous administration of nivolumab
16046507|NCT02550223|Procedure|radial artery Catheterization|Insertion of radial artery catheter for sampling and blood pressure measurement
16046508|NCT02550210|Device|Breast Cancer Locator (BCL)|This locator is constructed pre-operatively, sterilized and provided to the surgeon at the time of the procedure. The outline of the breast cancer on the breast surface at the point where the cancer is closest to the skin is built into the locator, so that the surgeon can simply apply the locator to the patient's breast and trace the tumor outline on the skin.
16046509|NCT02550197|Biological|Quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016|0.5 mL, Intramuscular
16046510|NCT02550197|Biological|Trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation|0.5 mL, Intramuscular
16046511|NCT02550184|Other|Focused ultrasonographic examination.|Focused ultrasonographic examination of the lungs and the heart of patients who fulfill the inclusion criteria and who have given their informed and written consent for participation.
16046512|NCT02550158|Procedure|Educational program EDU-MICI|
16046513|NCT02550145|Drug|Exendin (9-39)|IV infusion of Exendin (9-39) during standardized oral glucose tolerance test (OGTT).
16046514|NCT02550145|Other|Placebo|IV infusion of Placebo (normal saline) during standardized oral glucose tolerance test (OGTT)
16046515|NCT02550132|Procedure|Spinal manipulation|Participants will lie down during the 45-minute experimental session. Vertebral displacements (cm) and muscle response amplitude (RMS value) will be recorded through kinematic markers (on T6, T7 and T8 spinous processes) and surface electromyography electrodes (on the left and right erector spinae at T6 and T8 vertebra level). Each SMT (4 per participant) will be delivered at T7 transverse processes by an apparatus. Responses during the thrust phase (duration equal to twice the time to peak force) and after the thrust (1,5s duration) will be compared between SMTs.
16046516|NCT02550132|Device|Apparatus used to deliver spinal manipulations|An apparatus using a servo-controlled linear actuator motor (Linear Motor Series P01-48x360, LinMot Inc., Switzerland) will be used to deliver spinal manipulations.
16046517|NCT02550119|Drug|Aprepitant|Given PO
16046518|NCT02550119|Drug|Dexamethasone|Given PO or IV
16046519|NCT02550119|Drug|Dolasetron Mesylate|Given PO or IV
16046520|NCT02550119|Drug|Placebo|Given PO
16046521|NCT02550106|Drug|OMALIZUMAB|sub cutaneous injections of 300 mg every 4 weeks until Week 8.
16046522|NCT02550093|Drug|Normal Saline|Each subject will receive nasal spray(s) into each nostril of 4 Units up to 32 units of study drug prior to Thermal Evaluation System Testing.
16046523|NCT02550093|Drug|Oxytocin|Each subject will receive nasal spray(s) into each nostril of 4 Units up to 32 units of study drug prior to Thermal Evaluation System Testing.
16046524|NCT02550080|Drug|Dapsone|For the HLA-B*1301 positive subjects, dapsone will not be administrated.
16046525|NCT02550080|Genetic|HLA-B*1301|The prospective genetic screening group will be tested before administrating dapsone
16046526|NCT02550067|Drug|DMPA|Women randomized to DMPA, will receive an intramuscular injection of DMPA (medroxyprogesterone acetate sterile aqueous suspension 150 mg per 1 mL) at enrolment. Subsequent injections will be given every 3 months (i.e., at quarterly study visits) at the study site.
16046527|NCT02550067|Drug|LNG|Women randomized to implants will receive LNG implants in the arm, at enrolment from trained clinicians.
16046528|NCT02550067|Drug|Copper IUD|Women randomized to IUDs will receive their IUDs at enrolment. Trained providers will insert T380a copper IUDs using standard insertion techniques.
16046529|NCT02550054|Drug|Epo|Epo is administered 1000 U/kg, iv in 48 hours after premature birth, and at 48 hours interval for 3 doses per week. After 6 doses, subcutaneously 400 U/Kg per injection and 3 doses per week until at corrected age of 34 weeks.
16046530|NCT02550054|Drug|Normal saline|Normal saline is administered 5ml, iv at 3 to 6 hours after premature birth, and at 48 hours interval for 3 doses per week. After 6 doses, Subcutaneously 3 doses per week until at corrected age of 34 weeks.
16046531|NCT02550041|Other|T specific response for diagnostic of aspergillus bronchitis|
16046532|NCT02550028|Drug|Oral levetiracetam|Oral load of levetiracetam (50 mg/kg) following identification of EEG confirmed neonatal seizure.
16046533|NCT02550028|Drug|Intravenous phenobarbital|Intravenous load of phenobarbital (20 mg/kg)following EEG confirmation of seizure activity load.
16046534|NCT02550015|Behavioral|High intensity interval training|Uphill treadmill walking
16046535|NCT02550015|Behavioral|General information|Standard care
16046536|NCT02550002|Drug|Aflibercept|Intravitreal injection
16046537|NCT02549989|Drug|LY3023414|Enrolled patients will take LY3023414 200 mg orally twice a day. Each cycle will be 21 days in duration. Patients will receive study treatment until disease progression, intolerable toxicity, elective withdrawal from the study, study completion, or study termination
16046538|NCT02549976|Procedure|Abdominal MRI|Abdominal MRI to realize within 4 months following inclusion
16046539|NCT02549976|Procedure|Upper endoscopy|Upper endoscopy to realize within 4 months following inclusion
16046540|NCT02549976|Procedure|Colonoscopy|Colonoscopy to realize within 4 months following inclusion
16046541|NCT02549976|Procedure|Pelvic MRI|Pelvic MRI to realize within 4 months following inclusion
16046542|NCT02549963|Device|WATCHMAN Left Atrial Appendage Occlusion Device|
16046543|NCT02549963|Drug|Rivaroxaban|
16046544|NCT02549950|Procedure|Peizocorticision|Peizocorticision a non invasive procedure used in/ to accelerate orthodontic tooth movement
16046545|NCT02549950|Procedure|Conventional Orthodontic Mechanics|Full Fixed Orthodontic Appliance with conventional orthodontic Mechanics
16046547|NCT02549924|Drug|Resveratrol|Resveratrol capsules, 500 mg 3 times daily with the first bite of each meal
16046548|NCT02549924|Drug|Placebo|Placebo capsules, 500 mg 3 times daily with the first bite of each meal
16046549|NCT02549911|Other|HIPEC,Chemotherapy AND surgery|"HIPEC（RHL-2000B, Madain Medical Devices Co., Ltd., Jilin, China): Taxol (Paclitaxel Injection) 75 mg/m2, twice, within 72 hours after surgical exploration ; oral chemotherapy:S-1(Tegafur,Gimeracil and Oteracil Potassium Capsules): 80mg/m2, twice daily (after the breakfast and supper) for two weeks, and then suspend for one week.
~chemotherapy(PS for 3 cycles) : Taxol 150mg/m2,d1, S-1: 80mg/m2, twice daily (after the breakfast and supper) for two weeks, and then suspend for one week.
~surgery:Secondary surgical exploration:if PCI less than 20,then perform the cytoreductive surgery(resection of primary tumors and metastases )
~after the surgery,HIPEC for two cycles,and PS chemotherapy for 3 cycles"
16046550|NCT02549898|Drug|Feraheme|Feraheme is an USPIO agent, which will be applied as a contrast agent to visualize vascular inflammation in unilateral migraine without aura.
16046551|NCT02549898|Drug|Cilostazol|Cilostazol will be applied to provoke migraine attacks in migraineurs
16046552|NCT02549898|Other|USPIO-MRI|USPIO-MRI scans will be performed in order to assess possible vascular inflammation associated with migraine attacks.
16046553|NCT02549898|Other|BBI-MRI|Black blood MRI scans will be performed in order to asses changes in vessel wall thickness due to possible vascular inflammation associated with migraine attacks.
16046554|NCT02549885|Other|PNF contract-relax|Proprioceptive neuromuscular facilitation, using the technique of contract-relax on neck diagonal.
16046555|NCT02549885|Other|Static stretching|Static stretching of neck muscles.
16046556|NCT02549872|Other|This is not an intervention study|This study is based on the retrospective analysis of linked electronic health records.
16046557|NCT02549859|Device|Deep Brain Stimulation (DBS) at 60 Hz|Bilateral subthalamic nucleus deep brain stimulation at 60 Hz
16046558|NCT02549859|Device|Deep Brain Stimulation (DBS) at 130 Hz|Bilateral subthalamic nucleus deep brain stimulation at 130 Hz
16046559|NCT02549859|Device|Deep Brain Stimulation (DBS) Off (Sham)|Deep Brain Stimulation (DBS) Off (Sham)
16046560|NCT02549846|Drug|Statin|Randomized controlled trial of early versus late statin therapy in patients with ischemic stroke
16046561|NCT02549833|Biological|GBM6-AD and poly-ICLC before and after surgery|Subcutaneous vaccination with GBM6-AD lysate protein and poly-ICLC combination
16046562|NCT02549833|Biological|GBM6-AD and poly-ICLC after surgery only|Subcutaneous vaccination with GBM6-AD lysate protein and poly-ICLC combination
16046563|NCT02549820|Device|GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter|Fetoscopic Endoluminal Tracheal Occlusion (FETO) in CDH with GoldBAL2 Detachable Balloon and BALTACCIBDPE100 Delivery Catheter
16046564|NCT02549807|Device|Muscle elasticity measure|an ultrasound examination will be conducted on the hemiplegic leg side, while lying on his stomach and on the back. The thickness, elasticity and the angle of the medial gastrocnemius muscle pennation will be measured.
16046565|NCT02549794|Procedure|CT angiography with high concentration contrast agent|Standard concentration of iodine contrast agent for CT
16046566|NCT02549794|Procedure|CT angiography with low concentration contrast agent (320)|Two interventional arms use two different low concentration of iodine contrast agents, which is 320mgI/ml and 270mgI/ml respectively.
16046567|NCT02549794|Procedure|CT angiography with low concentration contrast agent (270)|Two interventional arms use two different low concentration of iodine contrast agents, which is 320mgI/ml and 270mgI/ml respectively.
16046568|NCT02549781|Other|Go-Nogo test|"In this study, Gambler performing Go-Nogo test. On a computer, various exercises (called Go-Nogo) whose principle is: 2 symbols (for example, a circle and a square) appear in random order on the screen computer. The patient will not press the response button (key on the keyboard) that upon the occurrence of one of the two symbols, in dependence upon the command that it has been given by the psychiatrist, and this as quickly as possible. The patient will successively perform 3 versions of this exercise (with a neutral wallpaper, with neutral/games images or with neutral/games tones). Order of the 3 versions will be determined by randomization."
16046569|NCT02549768|Drug|Dexmedetomidine|At start of anesthesia, bolus of 1 mcg/kg of dexmedetomidine over 10 minutes and then infusion of 0.7 mcg/kg/h during surgery will be administered.
16046570|NCT02549768|Drug|Sodium Chloride 0.9%|Sodium chloride 0.9% with a pump programmed in same way as Dexmedetomidine pump
16046571|NCT02549755|Drug|11C-Acetate|"The 11C-Acetate radiopharmaceutical will be administered intravenously at a dose of 20-40 mCi (0.74-1.5 GBq).
~There will be a total of three 11C-acetate radiopharmaceutical administrations for each patient"
16046572|NCT02549742|Procedure|Electrochemotherapy|Electroporation by a device, Cliniporator, combined with chemotherapy, Bleomycin.
16046573|NCT02549742|Device|Cliniporator|Electric pulses , duration 100 microseconds, about 400 V given at 5000 Hz.
16046574|NCT02549742|Drug|Bleomycin|Administered intravenously or injected into the tumour before electroporation.
16046575|NCT02549729|Behavioral|pelvic floor muscle training|Women will be instructed to perform pelvic floor muscle training daily at home 4 sets of 10 maximum perceived voluntary contraction of the pelvic floor muscle sustained for 6 seconds followed by 5 flick voluntary contraction of the pelvic floor muscle. The 4 sets will be performed in 4 different positions (supine, all four, sit and standing). Twice a week they will receive a supervised session using the same protocol described above.
16046576|NCT02549716|Drug|IV acetaminophen|Patients in this group will receive IV acetaminophen and an oral placebo every 6 hours for a 14 day period. Blood and CSF samples will be collected from patients throughout the 14 day period.
16046577|NCT02549716|Drug|Oral acetaminophen|Patients in this group will receive oral acetaminophen and an IV saline solution placebo every 6 hours for a 14 day period. Blood and CSF samples will be collected from patients throughout the 14 day period.
16046578|NCT02549716|Drug|Oral placebo|Patients who receive IV acetaminophen will also receive an oral placebo with their IV treatments (every 6 hours for a 14 day period).
16046579|NCT02549716|Drug|IV placebo|Patients who receive oral acetaminophen will also receive a saline solution placebo at the same time that they receive the oral acetaminophen treatment (every 6 hours for 14 days).
16046580|NCT02549690|Drug|Testosterone gel|Apply 10mg testosterone gel to the abdomen and rub on with one finger, once a day, in the morning, then allow sites to dry and cover with clothing. Continue the treatment for 6-8 weeks until next IVF treatment.
16046581|NCT02549690|Drug|DHEA|Take DHEA 25mg tablet orally, three times per day. Continue the treatment for 6-8 weeks, until next IVF treatment.
16046582|NCT02549677|Drug|Epirubicin|epirubicin, 90mg per square meter, every 3 weeks, day 1
16046583|NCT02549677|Drug|Docetaxel|docetaxel, 75mg per square meter, every 3 weeks, day 1
16046584|NCT02549677|Drug|cyclophosphamide|cyclophosphamide, 600mg per square meter, every 3 weeks, day 1
16046585|NCT02549651|Drug|MEDI4736|MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb) administered via intravenous infusion
16046586|NCT02549651|Drug|tremelimumab|Tremelimumab is an anti-CTLA4 monoclonal antibody (MAb) administered via intravenous infusion
16046587|NCT02549651|Drug|AZD9150|AZD9150 is an antisense oligonucleotide (ASO) administered via intravenous infusion
16046588|NCT02549638|Genetic|DNA Extraction|We will then extract DNA from tissue sections and blood and use a custom targeted sequencing panel of 23 cancer driver genes with significant mutations in squamous cell carcinoma that we have developed to find the prognostic biomarkers. The DNA will be used in a PCR reaction to generate amplicons for library preparation using Illumina Nextera XT library preparation protocol and targeted sequencing on the Illumina Hiseq sequencer. The reads will be aligned to the HG19 using BWA aligner and variant detection performed with Agilent SureCall and GATK analytic tools.
16046589|NCT02549625|Biological|Autologous Bone Marrow-derived Mononuclear Cells|
16046590|NCT02549612|Device|Moniri Otovent|Please see arm description.
16046591|NCT02549599|Behavioral|Chat/Text Program|Participants will receive access to the Chat/Text program on the internet via computer or mobile device. The Chat/Text program involves interactive, immediate, and tailored messages (with pre-determined content) delivered by Chat/Text agents via online chat or mobile phone text. At the conclusion of the session, the participants will receive a combination-baseline and follow-up survey.
16046592|NCT02549599|Behavioral|Website Content|Participants will be directed to content and information on the Planned Parenthood website. The website contains information on birth control methods, locations of Planned Parenthood health clinics, and on sexual and reproductive health more broadly.
16046593|NCT02549599|Other|Delayed Treatment|Participants will receive a baseline survey and be routed to the Planned Parenthood website. No subsequent survey will be administered
16046594|NCT02549586|Drug|Autologous Hematopoietic Stem Cell Transplant|"Step 1: Participants will receive intravenous chemotherapy and cytokine-based treatment for mobilization of hematopoietic stem cells (HSC) into the circulation, followed by collection using peripheral vein leukopheresis. The HSC graft product will undergo ex vivo purification with CD34 selection using Miltenyil CliniMACS and cryopreserved.
~Step 2: Intravenous busulphan, cyclophosphamide and anti-thymocyte globulin will be administered to participants to achieve immune ablation prior to the infusion of the participants' own thawed HSC graft product (HSC transplant). Routine supportive measures will be employed during the recovery from the chemotherapy and HSCT. Participants' immune suppression will be stopped at the time of immunoablative therapy and will be switched to everolimus which will be discontinued at 6 months post HSCT."
16046674|NCT02549040|Drug|Treatment A: Doravirine 100 mg film coated tablet|Single doravirine 100 mg film coated tablet administered orally at the start of Period 2
16046595|NCT02549573|Drug|APOKYN|Subjects in the APOKYN+ group will administer his/her usual dose of APOKYN at the PT clinic, as instructed by the Physical Therapist. These subjects will not take carbidopa/levodopa for at least 3 hours before or during the PT Intervention Visit.
16046596|NCT02549573|Behavioral|Physical Therapy|All subjects will participate in a standardized PT intervention
16046597|NCT02549560|Device|tDCS|Application of two daily sessions of cerebral stimulation starting from the first day after de surgery, for 4 consecutive days, with each session having 20 minutes, having an 8 hour minimum break between them. Will be applied a direct current stimulus of 2 milliampere (mA) (right anode/left cathode) in the prefrontal right region.
16046598|NCT02549547|Behavioral|Group Medical Visits|"Cohorts will participate in a weekly series of 14 Group Medical Visits (GMVs) co-led by a psychiatrist and an exercise professional. Each two-hour Group Medical Visit will be divided into three sections:
~Group check in/out; enter patients weekly step count into database; review and outline the day's group program - 20 minutes
~Group discussion, regarding selected physical activity topics including psychiatric issues - 50 minutes
~Physical activity component - 50 minutes The 'content' or curriculum of the GMVs will support participant Self-Management/Activation. Research has consistently emphasized the role of positive feedback, social support, reinforcement, goal setting, and motivation for improving person's self-perception to uptake physical activity."
16046599|NCT02549534|Procedure|Axon Reflexes|"*Axon reflexes will be evoked in the palmar surface of the right great toe using local skin heating with a 0.33 cm2 heat probe using the following protocol:
~Baseline: Heating the skin of the toe for a minimum of 5 minutes at 33*C.
~Heat Ramp: Increasing the heat in the heat probe to 42*C at approx. 0.1*C/10 sec.
~Skin Heating: Heating the skin of the toe for 30 minutes 42*C.
~Heat Ramp: Increasing the heat in the heat probe to 44*C at 0.1*C/10 sec..
~Skin Heating: Heating the skin for an additional 5 minutes at 44*C.
~The size of the axon reflex during this skin heating protocol will be imaged using Laser Doppler Flowmetry (LDF). In the case that participants develop CIPN on their left side only, the left toe will be substituted."
16046600|NCT02549534|Procedure|Axon Flares|Axon flares will be generated on the palmar surface of the right great toe using the same local skin heating protocol described above, and imaged using a laser speckle contrast imager (LSCI) (also known as full-field laser perfusion imager, or FLPI).
16046601|NCT02549534|Procedure|Self-Reported Signs & Symptoms of CIPN|Self-reported signs & symptoms of CIPN such as the presence and location of (1) tingling, (2) numbness, and (3) neuropathic pain, along with information about (4) deficits in vibration thresholds, and (5) loss of deep tendon reflexes will be assessed at each study visit using the 5-item, modified Total Neuropathy Score (mTNS).
16046602|NCT02549521|Dietary Supplement|Oral magnesium substitution|The elderly was given tablets two times daily with calsium and vitamin D. They were further given magnesium tablets 120 mg two times daily for 28 days.
16046603|NCT02549521|Dietary Supplement|Placebo tablets without magnesium|The elderly was given tablets two times daily with calsium and vitamin D. They were further given placebo without magnesium two times daily for 28 days.
16046604|NCT02549508|Device|AutoCPAP with SensAwake On|The comfort feature 'SensAwake' will be turned on
16046605|NCT02549508|Device|AutoCPAP with SensAwake Off|The comfort feature 'SensAwake' will be turned off
16046606|NCT02549482|Other|Respiratory resistor|The volunteers are breathing through the four respiratory resistors (inspiratory, expiratory, combined in- and expiratory and no resistor) in order to increase the intrathoracic pressure svings
16046607|NCT02549469|Drug|Naproxen Sodium ER (BAY117031), 20% HPMC|1 tablet 660 mg administered orally once daily
16046608|NCT02549469|Drug|Naproxen Sodium ER (BAY117031), 30% HPMC|1 tablet 660 mg administered orally once daily
16046609|NCT02549469|Drug|Naproxen Sodium ER (BAY117031), 40% HPMC|1 tablet 660 mg administered orally once daily
16046610|NCT02549469|Drug|Aleve (Naproxen Sodium, BAY117031)|1 tablet 220 mg administered orally three times daily
16046611|NCT02549456|Procedure|natural orifice specimen extraction|Conventional laparoscopic resection of colorectal cancer is done then specimen is extracted through natural orifice (anal or vaginal orifice).
16046612|NCT02549456|Procedure|Laparoendoscopic resection|"Endoscopic phase: Transanal platform is inserted into the rectum, and pneumorectum is established. The lumen is occluded below the level of the tumor. The avascular ''oncologic'' presacral plane is entered posteriorly, and dissection proceeds cephalad in the total mesorectal excision planes. Next, the abdominal cavity is entered at the peritoneal reﬂection. The superior rectal artery is divided. The rectal stump then is reﬂected into the abdominal cavity, and retrograde dissection is performed until the procedure is limited by instrument length.
~Laparoscopic phase: Colon mobilization, lymph node dissection, and mesenteric excision are performed laparoscopically. Mobilization of the splenic ﬂexure is done if needed."
16046613|NCT02549443|Dietary Supplement|Amino acids|AA (Travasol Baxter, Deerfield IL) during and after surgery in an amount equivalent to 20% and 35% of the patient's energy expenditure (EE)
16046614|NCT02549430|Drug|Palbociclib|Palbociclib 125 mg/day orally in an ongoing 3:1 schedule (3 weeks on/1 week off)
16046615|NCT02549430|Drug|Anastrozole|Continuation of prior anastrozole 1mg/day orally in a continuous regimen
16046616|NCT02549430|Drug|Letrozole|Continuation of prior letrozole 2.5mg/day orally in a continuous regimen
16046617|NCT02549430|Drug|Exemestane|Continuation of prior exemestane 25mg/day orally in a continuous regimen
16046618|NCT02549430|Drug|Fulvestrant|Continuation of prior fulvestrant 500mg intramuscular injection every 4 weeks in a continuous regimen
16046619|NCT02549417|Drug|KHK7580|Oral administration
16046620|NCT02549404|Drug|KHK7580|Oral administration
16046621|NCT02549391|Drug|KHK7580|Oral administration
16046622|NCT02549391|Drug|KRN1493|Oral administration
16046623|NCT02549378|Device|confocal microscopy|microvessel diameter measured by confocal microscopy
16046624|NCT02549365|Drug|Live attenuated influenza vaccine|Administration of LAIV, with subsequent surveillance (nasal swabbing) during influenza season
16046625|NCT02549365|Procedure|Surveillance (nasal swabbing) during influenza season|
16046626|NCT02549352|Drug|LEO43204 gel|
16046627|NCT02549352|Drug|Vehicle gel|
16046628|NCT02549339|Drug|LEO 43204 gel|
16046629|NCT02549339|Drug|Vehicle gel|
16046630|NCT02549326|Dietary Supplement|vitamin D|
16046631|NCT02549326|Dietary Supplement|Placebo|
16046738|NCT02548611|Drug|Prasugrel|see arm description
16046632|NCT02549313|Procedure|position changes of the head|Registration of blood flow changes induced when the patient's head will be tilted at 0 ° (that is to say flat), 15 ° and 30 ° (the order of actions will be determined by drawing lots). The patient will remain 10 minutes in each of these positions.
16046633|NCT02549300|Other|Connective tissue massage|It is a manual reflex therapy in that it is applied with the therapist's hands which are in contact with the patient's skin. The assessment of the patient and the clinical decision-making that directs treatment is based on a theoretical model that assumes a reflex effect on the autonomic nervous system which is induced by manipulating the fascial layers within and beneath the skin.
16046634|NCT02549287|Behavioral|SafeCare|An evidence-based home visiting program
16046635|NCT02549287|Behavioral|Supportive Case Management|Child welfare services as usual
16046636|NCT02549274|Other|self-rehabilitation + physiotherapy|2 training sessions in self-rehabilitation at the hospital and then a self-rehabilitation / day session + 14 physiotherapy sessions (2 by week)
16046637|NCT02549274|Other|physiotherapy|14 physiotherapy sessions (2 by week)
16046638|NCT02549261|Drug|nimotuzumab|the nimotuzumab treatment: 200mg/w weekly, for 16 weeks. A treatment:nimotuzumab for 3 levels (100mg/w, 200mg/w, 400mg/w, weekly, for 16 weeks).
16046639|NCT02549261|Drug|Cisplatin|Concurrent Chemotherapy,50mg/m2 (d1,d8),4 weeks/cycle, for 2 cycles. the consolidation chemotherapy: Cisplatin: 50mg/m2 (d1,d8)4 weeks/cycle, for 2 cycles.
16046640|NCT02549261|Drug|Etoposide|"Concurrent Chemotherapy, Cisplatin: Etoposide: 50mg/m2 (d1-5)，4 weeks/cycle, for 2 cycles.
~the consolidation chemotherapy:Etoposide: 50mg/m2 (d1-5)，4 weeks/cycle, for 2 cycles."
16046641|NCT02549261|Radiation|radiotherapy|the tolerance trial of treatment A and B of treatment;95％PTV,60-66Gy/30-33/fraction,6-7weeks.
16046642|NCT02549248|Other|BAL|Patients with idiopathic and non idiopathic interstitial lung diseases
16046643|NCT02549248|Other|BW|Patients with idiopathic and non idiopathic interstitial lung diseases
16046644|NCT02549248|Other|EAC|Patients with idiopathic and non idiopathic interstitial lung diseases
16046645|NCT02549248|Other|blood specimen|Patients with idiopathic and non idiopathic interstitial lung diseases
16046646|NCT02549248|Other|Urine specimen|Patients with idiopathic and non idiopathic interstitial lung diseases
16046647|NCT02549235|Other|Ultrasound|Routine 2D/3D ultrasound assessment
16046648|NCT02549222|Other|Standard of Care|
16046649|NCT02549209|Drug|Pembrolizumab|Pembrolizumab 200 mg will be administered every 3 weeks for all subjects
16046650|NCT02549209|Drug|Paclitaxel|"For subjects with no prior therapy, paclitaxel will be dosed at 175mg/m2 and be administered as a 3-hour continuous IV infusion.
~Subjects with prior XRT/platinum-based chemotherapy must initiate paclitaxel at 135mg/m2 and be administered as a 3-hour continuous IV infusion."
16046651|NCT02549209|Drug|Carboplatin|"For subjects with no prior therapy, carboplatin will be dosed at an AUC of 6 and given as an IV infusion in 250ml of D5W over 30 minutes.
~Subjects with prior XRT/platinum-based chemotherapy must initiate carboplatin at an AUC of 5 given as an IV infusion in 250ml of D5W over 30 minutes."
16046652|NCT02549196|Drug|Donepezil|Donepezil dose increased at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) together with solifenacin.
16046653|NCT02549196|Drug|Solifenacin|Donepezil dose increased at weekly intervals up to first intolerable dose (FID) or to maximum allowed dose (MAD) together with solifenacin.
16046654|NCT02549183|Device|Boston Scientific PRECISION Spinal Cord Stimulator System|Spinal cord stimulation randomly programmed to KHz frequencies; A, B, C and D Kilo Hertz.
16046655|NCT02549170|Biological|HYQVIA|Participants will receive HYQVIA/HyQvia SC which contains both Immune Globulin Infusion 10% (Human) (IGI, 10%) and recombinant human hyaluronidase (rHuPH20).
16046656|NCT02549170|Biological|0.25% albumin placebo solution with rHuPH20|Participants will receive placebo solution (0.25% human albumin in Lactated Ringer's solution) and rHuPH20.
16046657|NCT02549170|Biological|IGIV|Participants will receive GAMMAGARD LIQUID/KIOVIG (all participants with the exception of those at US sites) or GAMUNEX®-C (participants at US sites only).
16046658|NCT02549157|Procedure|Pelvic Floor Muscle Training|
16046659|NCT02549144|Dietary Supplement|Low versus high fat/cholesterol diet|The low fat/cholesterol diet had 10% calories from fat and 150-200 mg of cholesterol per day.The high fat/cholesterol diet had 40% calories from fat and 250-300 mg of cholesterol per day.
16046660|NCT02549131|Procedure|Randomizing to Suture or Staple closure of Cesarean section|Randomizing to either surgical subcuticular suture or surgical staples in women of BMI greater than 40 undergoing Cesarean section delivery.
16046661|NCT02549118|Drug|Tenoxicam|
16046662|NCT02549118|Drug|Pethidine|
16046663|NCT02549105|Drug|EMLA CREAM 5 mg|EMLA CREAM APPLICATION FOR WOUND AFTER CS
16046664|NCT02549105|Drug|LIDOCAINE 1 %|LIDOCAINE 1 % INFILTERATION FOR WOUND AND ASSESSMENT OF PAIN IN FIRST 6 HOURS
16046665|NCT02549092|Drug|Optimized Medical Treatment|Oral, sublingual or transdermal anti-PD medications and medications to treat NMS per Investigator discretion and/or in accordance with approved product label of the prescribed medications.
16046666|NCT02549092|Drug|Levodopa-Carbidopa Intestinal Gel|
16046667|NCT02549092|Device|Nasojejunal (NJ) tube|optional prior to PEG-J placement
16046668|NCT02549092|Device|Percutaneous endoscopic gastrostomy with a jejunal (PEG-J) tube|
16046669|NCT02549079|Other|Blood sample|Blood will be taken from all patients meeting the inclusion criteria.
16046670|NCT02549066|Procedure|Increased cardiopulmonary bypass flow|In randomized order, CPB flow will be adjusted to 2,4, 2,7 and 3,0 L/min/m2. After 10 minutes of steady conditions at each level, measurements will be made.
16046671|NCT02549066|Drug|Milrinone|"After weaning from CPB, patients with signs of cardiac failure (as defined below) will be given milrinone (0,04 mg/kg as a loading dose and 0,50 ug/kg/min as subsequent infusion). Measurements of systemic and renal variables will be made before and 30 minutes after the dose.
~Indication: Central venous pressure (CVP) ≥ 12 mmHg AND/OR Pulmonary Capillary Wedge Pressure (PCWP) ≥ 16 mmHg AND Cardiac Index (CI) ≤ 2,1 L/min/m2 AND Pulse Pressure Variation (PPV) < 12 %."
16046672|NCT02549053|Procedure|esophagus biopsies (pathologic and healthy zones)|Biopsies were realised in the distal third of esophagus : 4 for Barrett esophagus patients (2 in healthy zone, 2 in pathological zone).
16046673|NCT02549053|Procedure|esophagus biopsies (healthy zones)|Biopsies were realised in the distal third of esophagus :2 for control patients in healthy zone
16046675|NCT02549040|Drug|Treatment B: Doravirine 150 mg tablet (40% drug loaded granule)|Single doravirine NF Type 1 dose (150 mg tablet [40% drug loaded granule]) administered orally at the start of Period 1
16046676|NCT02549040|Drug|Treatment C: Doravirine 150 mg tablet (30% drug loaded granule)|Single doravirine NF Type 2 dose (150 mg tablet [30% drug loaded granule])administered orally at the start of Period 3
16046677|NCT02549040|Drug|Treatment D: Doravirine 150 mg tablet (50% drug loaded granule)|Single doravirine NF Type 3 dose (150 mg tablet [50% drug loaded granule])administered orally at the start of Period 4
16046678|NCT02549040|Drug|Treatment E: Doravirine 100 mg tablet (30% drug loaded granule)|Single doravirine NF Type 4 dose (100 mg tablet [30% drug loaded granule]) administered orally at the start of Period 5
16046679|NCT02549027|Drug|MK-1064|Oral MK-1064 tablets (10 and 50 mg strengths)
16046680|NCT02549027|Drug|MK-6096|Oral MK-6096 tablets (5 mg strength)
16046681|NCT02549027|Drug|Placebo|Oral placebo tablets (matching active MK-1064 tablets, matching active MK-6096 tablets)
16046682|NCT02549014|Drug|MK-1064|Dose for each period administered as oral MK-1064 tablets (1, 10 and 50 mg strengths)
16046683|NCT02549014|Drug|Placebo|Dose for each period administered as oral placebo tablets matching active MK-1064 tablets
16046684|NCT02549001|Drug|P-3058 10%|
16046685|NCT02549001|Drug|vehicle of P-3058 10%|
16046686|NCT02549001|Drug|amorolfine 5%|
16046687|NCT02548988|Other|Neuromuscular Electrical Stimulation|Selective Neuromuscular Electrical Stimulation on VMO
16046688|NCT02548975|Drug|Statin, beta blocker|Patients receiving either statin or beta blockers prior to cardiac surgery.
16046689|NCT02548975|Other|Cardiopulmonary bypass|Patients exposed to cardiopulmonary bypass during cardiac surgery.
16046690|NCT02548962|Drug|Ibrutinib|
16046691|NCT02548962|Drug|Pomalidomide|
16046692|NCT02548962|Drug|Dexamethasone|
16046693|NCT02548962|Drug|Placebo|
16046694|NCT02548936|Drug|Ezetimibe+Simvastatin Drug Combination|The patients in Ezetimibe+Simvastatin Drug Combination group received simvastatin (10mg/day) + ezetimibe (20 mg/day) by oral administration for 12 month.
16046695|NCT02548923|Drug|Dexmedetomidine|comparison to propofol
16046696|NCT02548910|Procedure|Phlebotomy|A central venous catheter will be inserted for every patient to measure central venous pressure, as is the standard of care in elective liver surgery. Strict aseptic technique will be maintained. A total volume of whole blood of 7-10 mL per kg of body weight will be removed, as tolerated. The volume of removed blood will not be replaced by intravenous fluid administration. Collected blood will be transfused back at the end of the liver parenchymal transection, or within 8 hours of collection.
16046697|NCT02548910|Device|Citrated whole blood collection bag|Transfusion Medicine will send the requested number of whole blood collection bags labelled with the patient's name and MRN. These whole blood collection bags are used in standard practice for collection of whole blood.
16046698|NCT02548897|Device|Deep brain stimulation|The programming of DBS settings in all participants with bilateral DBS implants in the globus pallidus internus (GPi) and pedunculopontine nucleus (PPN) will be performed.
16046699|NCT02548897|Other|Electroencephalography|An electroencephalography (EEG) will be performed on all participants to better understand the neurophysiological underpinnings of the symptom.
16046700|NCT02548884|Procedure|Biliary cannulation|
16046701|NCT02548871|Behavioral|Teen Outreach Program|TOP® is a positive youth development and service learning program for youth ages 12 to 17, and its Changing Scenes curriculum is separated into age appropriate levels. The program uses an approach that involves a caring adult, positive self-efficacy, future planning and goal setting and life management skills to to reduce risky sexual behavior and improve school outcomes. TOP® is designed to be delivered in weekly sessions over 9 months and includes community service learning.
16046702|NCT02548858|Procedure|Perineorrhaphy|Those patients who are randomized to undergo a perineorrhaphy as part of their vaginal or abdominal reconstructive procedure for pelvic organ prolapse.
16046703|NCT02548858|Procedure|No Perineorrhaphy|Those patients who are randomized not to undergo a perineorrhaphy as part of their vaginal or abdominal reconstructive procedure for pelvic organ prolapse.
16046704|NCT02548832|Drug|Berberine|Berberine capsules, 500 mg 3 times daily with the first bite of each meal
16046705|NCT02548832|Drug|Bezafibrate|Bezafibrate capsules, 200 mg 2 times daily with the first bite of each meal
16046706|NCT02548832|Drug|Placebo|Placebo capsules, 500 mg 3 times daily with the first bite of each meal
16046707|NCT02548832|Drug|Placebo|Placebo capsules, 200 mg 2 times daily with the first bite of each meal
16046708|NCT02548819|Other|MRI|MR imaging of patients with implanted cardiac devices
16046709|NCT02548806|Drug|Clonidine MBT 50µg|Clonidine MBT 50µg, single dose
16046710|NCT02548806|Drug|Clonidine MBT 100µg|Clonidine MBT 100µg, single dose
16046711|NCT02548806|Drug|Catapres 100μg|Catapres tablet 100μg, single dose
16046712|NCT02548793|Other|Education: CPR Training via Mobile App|Using a mobile app to train users on chest-compression only CPR. Subjects will be encouraged to share the app with family and friends.
16046713|NCT02548793|Other|Education: CPR Training using the CPR Anytime VSI Kit|Subjects will be trained using the American Heart Association's Family and Friends CPR Anytime Kit. Subjects will undergo training in-hospital and will be encouraged to take the kit home to share with their family members and friends.
16046714|NCT02548780|Device|Chemoembolization|"First, an angiography of the celiac trunk, superior mesenteric artery and hepatic artery will be obtained by using a peripheral arterial approach.
~Arterial embolization will be performed through catheterization of intrahepatic arteries, as selectively as possible (tumor feeders, subsegmental, segmental). The size of the microcatheter must be consistent with the size of LifePearl beads used. Microspheres of 200 µm will be be used. They will be loaded with the appropriate dose of doxorubicin injectable solution, mixed with the contrast media and distributed according to the location of the HCC lesions. The endpoint of the procedure will be achieved end when stasis of the feeders is achieved and confirmed with angiography of the whole liver."
16046739|NCT02548611|Drug|Clopidogrel|see arm description
16046740|NCT02548598|Procedure|Endoscopic sinus surgery|This is an observational trial of patients with and without asthma who have concomitant chronic rhinosinusitis requiring endoscopic sinus surgery.
16046741|NCT02548585|Drug|MEDI0382|MEDI0382 administered subcutaneously.
16046715|NCT02548780|Other|Pharmacokinetics|Pharmacokinetic analysis will be performed in cohort I and II after the first treatment only. In addition to blood samples taken for biochemistry and haematology analysis, blood will be taken for pharmacokinetic assessment: Whole venous blood samples (6 ml in 2 tubes) will be taken from peripheral blood into ethylenediaminetetraacetic acid (EDTA) tubes prior to and at 5mins, 20mins, 40mins, 1h, 2h, 6h, 24h, 48h and 7 days after the procedure, and if needed (i.e. value at d7 is detectable) at 1 month (for safety assessment visit) either during hospital stay or in the outpatient clinic.
16046716|NCT02548767|Other|high fructose corn syrup|High fructose corn syrup provided as 15% HFCS/85% water (weight/weight) fruit-flavored beverage
16046717|NCT02548767|Other|aspartame|Aspartame provided as 0.04% aspartame/99.96% water (weight/weight), fruit-flavored beverage
16046718|NCT02548767|Other|Energy-balanced diet|Provided in quantities that equal energy requirement. Formulated such that the overall macronutrient intake; including beverage; equal 45%/5% energy requirement at complex/simple carbohydrate, 35% energy requirement as fat, 15% energy requirement as protein.
16046719|NCT02548767|Other|Ad libitum diet|Provided in quantities that exceed energy requirement by approximately 25%. Formulated such that the overall macronutrient intake; including beverage; equals approximately 45%/5% energy requirement at complex/simple carbohydrate, 35% energy requirement as fat, 15% energy requirement as protein.
16046720|NCT02548754|Device|Parasym device|
16046721|NCT02548741|Drug|Metformin Hydrochloride (500-mg capsule)|Metformin hydrochloride tablets (500-mg) are manufactured by Heritage Pharma INC. Noha Ashy & David Lee will ground the tablets and put them in capsules to avoid differentiation between treatment and placebo. Using USP 797 compounding standers, Noha Ashy & David Lee will package the capsules to conceal it from the participants and other investigators. Compounding will take place at the lab, College of Pharmacy (Darchman building, 2nd floor), University of Arizona. New empty capsules (size 0, ½ blue-opaque and ½ white-opaque capsule which will be supplied by Letco Medical) will be provided to the treatment (metformin hydrochloride) arm participants that are similar to the placebo (comparator) capsules in term of color and size to conceal placebo from the investigators and participants.
16046722|NCT02548741|Drug|Calcium carbonate (placebo)|Investigators will use powder of calcium carbonate as filler of placebo capsules. Placebo capsules (size 0,½ blue-opaque and ½white-opaque capsule which will be supplied by Letco Medical),will be provided to the comparator arms' participants that are similar to the metformin hydrochloride capsules in term of color and size to conceal placebo from the investigators and participants.Using USP 797 compounding standers, Noha Ashy & David Lee will package the capsules to conceal it from the participants and other investigators. Compounding will take place at the lab, College of Pharmacy (Darchman building, 2nd floor), University of Arizona.
16046723|NCT02548741|Other|Glucometer (One Touch glucometer), strips and lancets|Investigators will provide glucometer (One Touch glucometer), strips and lancets to the treatment and placebo groups. They will be provided to patients who never had glucometer before enrolling to our study.Also, a logbook will be provided to each participant to record their blood sugar measurements at home.
16046724|NCT02548741|Other|Urine container for 24-hour urine collection|During visit 2 (day 0) and visit 3 (day 42), urine container will be provided to the study participant for 24-hour urine collection. Patient will be instructed to bring the container back to the collaboratory. Investigators will transfer the urine container to Dr.Lau's lab to measure the IMZ concentration/content.
16046725|NCT02548728|Drug|Intranasal Oxytocin Spray|10 insufflations (40IU of oxytocin total) given three times on day of enrollment and then twice daily for 4 days
16046726|NCT02548728|Drug|Placebo|10 insufflations (40IU of placebo, same solution as active treatment minus oxytocin) given three times on day of enrollment and then twice daily for 4 day
16046727|NCT02548715|Drug|Levothyroxine|
16046728|NCT02548715|Drug|Placebo|
16046729|NCT02548702|Behavioral|Fit4Life|Fit4Life is a programme whereby patients with type 2 diabetes are counselled and then allocated to a community-based sport programme based on their interests and perceived barriers to participation
16046730|NCT02548676|Device|Optical angiography based on OCT|This measurement will be obtained after the dilation of the pupil. Optical coherence tomography (OCT) is a non-invasive optical imaging modality enabling cross-sectional tomographic in vivo visualization of internal microstructure in biological systems. In ophthalmology OCT has become a standard device in visualizing the retina and is also considered a standard tool in the diagnosis of retinal disease. In optical angiography blood vessels contrasting against static tissue are visualized in a full depth resolved and label-free manner.
16046731|NCT02548663|Other|Sport therapy|"Frequency: 60 min three times/week
~20 min: aerobic training on bicycle ergometer.
~20 min: strength training at 60% of maximal load.
~20 min: proprioception and stretching exercises."
16046732|NCT02548663|Other|Osteopathic treatment|Frequency: 60 min weekly
16046733|NCT02548650|Drug|Vorapaxar|Triple therapy with DAPT plus vorapaxar (vorapaxar 2.5mg od plus clopidogrel 75 mg od and aspirin 81 mg od) will be administered for 30 days; then patients will stop aspirin and will take dual treatment (vorapaxar 2.5mg od plus clopidogrel 75 mg od ) for other 30 days
16046734|NCT02548650|Drug|Clopidogrel|Triple therapy with DAPT plus vorapaxar (vorapaxar 2.5mg od plus clopidogrel 75 mg od and aspirin 81 mg od) will be administered for 30 days; then patients will stop aspirin and will take dual treatment (vorapaxar 2.5mg od plus clopidogrel 75 mg od ) for other 30 days
16046735|NCT02548650|Drug|Aspirin|Triple therapy with DAPT plus vorapaxar(vorapaxar 2.5mg od plus clopidogrel 75 mg od and aspirin 81 mg od) will be administered for 30 days; then patients will stop aspirin and will take dual treatment (vorapaxar 2.5mg od plus clopidogrel 75 mg od ) for other 30 days
16046736|NCT02548637|Procedure|Acupuncture Therapy|The standard textbook of Chinese Acupuncture and Moxibustion is the source for the name and location of the points for this study. A total of 38 points will be used, divided between two acupuncture sessions: 20 points or 37 locations in the supine position; 18 points or 36 locations in the prone position. Other than points governing vessel (GV) 20, conception vessel (CV) 6, CV 10, all points will be performed bilaterally.
16046737|NCT02548624|Device|Zephyr BioPatch|"The ZephyrLIFE Hospital System includes the BioPatch™ device (consisting of the BioModule™ sensor, BioModule™ holder, and snap ECG electrodes), the ECHO radio system, and a software monitoring interface. The BioModule™ sensor is a Class II device, 510(k) cleared by the FDA, and commercially available.
~The ZephyrLIFE Hospital System stores, transmits and displays vital sign data including ECG, HR, RR, body orientation, and activity to caregivers via a central station."
16046743|NCT02548572|Device|Transcorneal Electrical Stimulation using Okustim device|"The Okustim® stimulation device is a battery-powered electronic neuro-stimulator, which delivers a weak electrical pulse. This current is delivered to the eyes by the OkuStim® device using the OkuEl® electrodes, which are held in place via the OkuSpex® frame. In this study the treatment level will be held constant at 0.8 mA for all study subjects. After switching on the neuro-stimulator, the subject's retina will be stimulated through specific electrodes (OkuEl, held in position by the OkuSpex) worn on the face with the predetermined intensity and time period (delivered by the OkuStim device)."
16046744|NCT02548559|Drug|Full-Spectrum Cannabidiol|Full-Spectrum Cannabidiol; total daily dose of 30 mg.
16046745|NCT02548559|Drug|Single-Compound Cannabidiol|Single-Compound Cannabidiol; total daily dose of 30 mg.
16046746|NCT02548559|Drug|Placebo|Placebo solution.
16046747|NCT02548546|Device|ECHO|Imaging
16046748|NCT02548546|Device|ECG-gated MRA|Imaging
16046749|NCT02548533|Device|AFXL|Pretreatment at 2.5 mJ/microbeam and 15% density.
16046750|NCT02548533|Drug|AHES|Topical application on AFXL pretreated skin 15 minutes prior to the treatment.
16046751|NCT02548533|Drug|EMLA cream|Topical application 2 hours prior to the treatment.
16046752|NCT02548520|Other|Blood and breastmilk samples|The investigators collected maternal and infants blood samples from birth, and 4 and 9 months forward, including breastmilk from the mothers at all visits
16046753|NCT02548507|Other|observational study, no intervention|
16046754|NCT02548494|Drug|Glargine|The control group will receive all traditional methods of treatment for DKA, including a placebo subcutaneous injection. The study group will receive the same treatment, but will be supplemented with a subcutaneous glargine injection.
16046755|NCT02548494|Drug|IV insulin|The intravenous infusion of insulin at a weight-based fixed rate until ketosis has subsided.
16046756|NCT02548494|Other|Electrolyte Correction|If the potassium level is greater than 6 mEq/L, do not administer potassium supplement. If the potassium level is 4.5-6 mEq/L, administer 10 mEq/h of potassium chloride. If the potassium level is 3-4.5 mEq/L, administer 20 mEq/h of potassium chloride.
16046757|NCT02548494|Other|Correction of Fluid Loss|"Initial correction of fluid loss is either by isotonic sodium chloride solution or by lactated Ringer solution. The recommended schedule for restoring fluids is as follows:
~Administer 1-3 L during the first hour.
~Administer 1 L during the second hour.
~Administer 1 L during the following 2 hours
~Administer 1 L every 4 hours, depending on the degree of dehydration and central venous pressure readings"
16046758|NCT02548481|Other|BESTA scale|BESTA scale is administrated at T0, T1 and T2.
16046759|NCT02548468|Drug|Fludarabine|Given IV
16046760|NCT02548468|Radiation|Total-Body Irradiation|Undergo TBI
16046761|NCT02548468|Biological|T Cell-Depleted Donor Lymphocyte Infusion|Undergo donor CD3+ enriched T lymphocyte infusion
16046762|NCT02548468|Drug|Cyclophosphamide|Given IV
16046763|NCT02548468|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic HSC transplant
16046764|NCT02548468|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo allogeneic PBSCT
16046765|NCT02548468|Drug|Mycophenolate mofetil|Given IV
16046766|NCT02548468|Drug|Tacrolimus|Given IV
16046767|NCT02548455|Device|Quartet 1457Q LV Lead|
16046768|NCT02548416|Procedure|Positive end-expiratory pressure|"Induction of anaesthesia is performed in a conventional manner using a target controlled infusion of propofol and remifentanil. Intubation of the trachea is facilitated by rocuronium.
~As soon as correct position of the endotracheal tube is confirmed, controlled ventilation is started with a tidal volume of 7 mL/kg body weight and a respiratory frequency of 10. The fresh gas flow is set to 1 litre/min with an oxygen mixture of 40%, aiming for an inspired oxygen fraction (FiO2) of 30-35%. Positive end-expiratory pressure is set to 6 or 8 cm H20 (8 if BMI>25) in the intervention group.
~Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure."
16046769|NCT02548416|Procedure|Control group, zero PEEP|"Induction of anaesthesia is performed in a conventional manner using a target controlled infusion of propofol and remifentanil. Intubation of the trachea is facilitated by rocuronium. As soon as correct position of the endotracheal tube is confirmed, controlled ventilation is started with a tidal volume of 7 mL/kg body weight and a respiratory frequency of 10. The fresh gas flow is set to 1 litre/min with an oxygen mixture of 40%, aiming for an inspired oxygen fraction (FiO2) of 30-35%. Zero PEEP is used.
~Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure."
16046770|NCT02548403|Drug|PEG-Asc|received 1 L solution of PEG-Asc at 7 p.m the evening before colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure
16046771|NCT02548403|Drug|PEG-Asc with simethicone|received 1 L solution of PEG-Asc at 7 p.m the evening before colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure. Two packs (200 mg/10 mL each) of simethicone (400 mg) was mixed with last 500 mL of additional clear fluid.
16046772|NCT02548390|Drug|RXDX-107|Subjects in this study will receive RXDX-107 intravenously at dose levels specified for their respective dose cohorts. Dosing will begin at 25 mg/m2 on Day 1 and Day 2 of a 28-day cycle and will escalate until the maximum tolerated dose (MTD) or (RP2D) is determined. An additional schedule of administration of RXDX-107 on Day 1 of a 28 day cycle may be assessed. Cycles will be repeated in four-week (28 day) intervals for up to 6 cycles or until progression of disease, unacceptable toxicity, or another discontinuation criterion is met.
16046773|NCT02548377|Procedure|Remote ischemic preconditioning|
16046774|NCT02548377|Procedure|Sham|
16046775|NCT02548364|Drug|Calcifediol|calcifediol treatment
16046776|NCT02548364|Drug|Placebo|placebo control group
16046777|NCT02548351|Drug|Obeticholic Acid|
16046778|NCT02548351|Drug|Placebo|
16046779|NCT02548338|Procedure|argon plasma coagulation|On the first group we use the regular electric scalpel to perform the surgery , and on the second group we use the argon plasma coagulation scalpel to perform the procedure.
16046780|NCT02548325|Other|Not apply|None. Just registration epidemiology dates
16046781|NCT02548312|Other|Variations of financial competing interest statements|Participants will be randomised to receive 1 of 2 review articles on different topics. For each review there will be 4 groups. Each of the 4 groups will receive an identical version of the review article with the exception of the competing interest statement which will vary depending on group assignment.
16047059|NCT02546427|Radiation|Permanent Prostate Implant (PPI)|
16046782|NCT02548299|Other|Nutrition Education|Nutrition classes will be led by a registered dietician.
16046783|NCT02548299|Other|Cooking Lecture|
16046784|NCT02548299|Other|Cooking Demo|
16046785|NCT02548299|Other|Hands-on Cooking|
16046786|NCT02548299|Other|e-Coaching|
16046787|NCT02548286|Drug|Candesartan 8mg|PO, 1day or 22day
16046788|NCT02548286|Drug|Amlodipine 5mg|PO, 1day or 22day
16046789|NCT02548286|Drug|CKD-330 8/5mg|PO, 1day or 22day
16046790|NCT02548260|Device|Syndactyly without compression|three week relative immobilization by syndactyly
16046791|NCT02548260|Device|Syndactyly with compression|three week relative immobilization by syndactyly and compression
16046792|NCT02548260|Device|Rigid splint without compression|three week rigid immobilization by splint
16046793|NCT02548260|Device|Rigid splint with compression|three week rigid immobilization by splint and compression
16046794|NCT02548247|Dietary Supplement|Orafti® Inulin|Dietary fiber
16046795|NCT02548247|Dietary Supplement|Placebo|Maltodextrin
16046796|NCT02548234|Other|Mirror therapy|Mirror therapy group received training for 1.5 hours/day, 3 days/week, for 4 weeks and home programs for 30-40 min/day, 5 days/week.
16046797|NCT02548234|Other|Bilateral arm training|Bilateral arm training group received training for 1.5 hours/day, 3 days/week, for 4 weeks and home programs for 30-40 min/day, 5 days/week.
16046798|NCT02548221|Device|transthoracic echocardiogram|Thoracentesis was performed on patients with large-volume pleural effusions, and TTE was utilized to access the change of heart and lung function before and after this medical procedure.
16046799|NCT02548208|Device|Verum focused extracorporeal shockwave|the concentrated shockwave energy per unit area (energy flux density EFD) can vary from 0.06 to 0.09 mJ/mm2. The pulse ratio per point is 200.
16046800|NCT02548208|Device|Sham shock wave|Sham shock wave is performed using the same device as stated above, but using a special applicator that has been isolated with layers of metal and water by the manufacturer, extinguishing the transmitted energy.
16046801|NCT02548195|Drug|oxaliplatin and gemcitabine|oxaliplatin and gemcitabine (GEMOX regimen): day 1: oxaliplatin 85 mg/m2, gemcitabine 1000 mg/m2; day 8: gemcitabine 1000 mg/m2 every three weeks for 6-8 cycles in total.
16046802|NCT02548195|Drug|capecitabine|capecitabine 1250 mg/m2, twice daily for two weeks plus one week rest for 8 cycles in total.
16046803|NCT02548182|Device|smartcare|Fit.life™ wireless physical activity tracker can measure daily physical activity including activity strength and time. It was chosen for its small size, accuracy in the measurement of physical activity, and convenient data upload via Bluetooth on participant mobile phone or wirelessly via a personal computer. Fit.life™ wireless physical activity tracker has been validated for measurement of free-living physical activity in adults [REF]. A smartphone application was customized for the use of the investigators' intervention, different for the 'smart care' group and 'smartcare plus financial incentive' group. The version for the latter group included the feature for the monitoring and feedback of financial incentives.
16046804|NCT02548182|Other|financial incentives|Financial incentives are provided in the form of process-based and outcome-based incentive.(maximum 320,000KRW) Process-based incentives were based on daily physical activity level. Participants in the 'smart care plus financial incentive' arms could earn incentives of up to 10,000 KRW per week according to the following schedule: 1,000 KRW if a participant reached target amount of physical activity in a day / An additional 3,000 KRW if a participant reached target amount of physical activity every day in a week. Outcome-based incentives were based on achievement of weight loss target at each visit. 50,000 KRW if a participant reached weight loss target of 3% from the baseline body weight at visit 2 (4 week)/ 50,000 KRW in weight loss target of 5% from the baseline body weight at visit 3 (8 week) / 100,000 KRW in weight loss target of 7% from the baseline body weight at final visit 4 (12 week)
16046805|NCT02548169|Biological|DC Vaccine + Standard of Care Chemotherapy|"4 doses of DC vaccine at 2 weeks interval, combined with either:
~Standard of care neoadjuvant folinic acid, oxaliplatin, irinotecan and 5- Fluorouracil (5FU) (FOLFIRINOX) regimen alone (6 cycles)
~FOLRIRINOX regimen followed by 5-FU chemoradiation or Gemcitabine Chemoradiation
~Gemcitabine + nab-paclitaxel
~The first vaccination will include one intradermal injection of 100 μL at 15 x106 cells/mL in the upper thigh and one subcutaneous injection of 1 mL (15 x 106 cells/mL) .
~The participants will receive 3 additional subcutaneous vaccinations, each injection of 1 mL at 15 x 106 cells/mL, at 2 weeks interval, on Day 2 of study weeks 3, 5 and 7.
~Participants will receive 2 booster DC vaccinations subcutaneously of 1 mL at 15x106 cells/mL."
16046806|NCT02548156|Other|Test Dentifrice|Marketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3
16046807|NCT02548156|Other|Reference Dentifrice|Marketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3
16046808|NCT02548156|Other|Comparator Dentifrice|Marketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3
16046809|NCT02548156|Other|Orange Juice|Teeth will be rinsed with orange juice followed by rinsing with de-ionised water in test dentifrice and comparator dentifrice arms.
16046810|NCT02548156|Other|De-ionised water|Teeth will be rinsed with de-ionised water followed by reference dentifrice and followed by rinsing with orange juice in test dentifrice and comparator dentifrice arms.
16046811|NCT02548143|Biological|Coagulation Factor VIIa (Recombinant)|LR769
16046812|NCT02548130|Other|MELD score|introduction of MELD score
16046813|NCT02548117|Drug|Finasteride|Subjects will take 5 mg finasteride orally every day for about 2 years.
16046814|NCT02548104|Other|ACB|ultrasound-guided ACB with 0.25% Bupivicaine with 1:200,000 epinephrine 30 ml and ultrasound-guided genicular (IPACK) with normal saline 15 ml
16046815|NCT02548104|Other|ACB + iPACK|ultrasound-guided ACB with 0.25% Bupivicaine with 1:200,000 epinephrine 30 ml and ultrasound-guided genicular (IPACK) with 0.25% Bupivicaine with 1:200,000 epinephrine 15 ml
16046816|NCT02548091|Other|Blood samples for assays of plasma inflammatory markers (cytokines InterLeukin-6, InterLeukin-8, InterLeukin-10)|"The same amount of blood sample is collected from both arms of study at the same time of the procedure.
~In each patient, in the per procedure period, a total of 50 milliliters of blood sample is drawn from the pulmonary circulation downstream and upstream of obstructive lesion, the trunk of pulmonary artery, the superior vena cava and the femoral arterial line prior to angioplasty and at the end of procedure; in the post interventional care unit 10 milliliters of blood sample will be draw daily from the superior vena cava catheter line and femoral arterial line."
16046817|NCT02548091|Procedure|Non invasive ventilation|
16046818|NCT02548091|Procedure|monitoring system Pulse-Induced Contour Cardiac Output (Picco)|
16046819|NCT02548091|Procedure|Computed tomography (CT)|
16046820|NCT02548078|Biological|GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A)|A single dose administered intramuscular
16046821|NCT02548078|Biological|Nimenrix powder and solvent for solution for injection in pre-filled syringe; Meningococcal group A, C, W-135 and Y conjugate vaccine|A single dose administered intramuscular
16046822|NCT02548065|Other|Balneotherapy|"Bath with mineral water named Debole of Vetriolo at 36°C, 15 minutes for 12 consecutive days in bathtubs"
16046823|NCT02548065|Other|Placebo|Bath with Thermal tap water
16046824|NCT02548052|Drug|GSK2981278 0.03%|GSK2981278 will be supplied as a white to off-white ointment containing GSK2981278A drug substance at a concentration of 0.03%. Approximately 200 microliters of the GSK2981278 0.03% ointment will be applied topically to the assigned test field once daily.
16046825|NCT02548052|Drug|GSK2981278 0.1%|GSK2981278 will be supplied as a white to off-white ointment containing GSK2981278A drug substance at a concentration of 0.1%. Approximately 200 microliters of the GSK2981278 0.1% ointment will be applied topically to the assigned test field once daily.
16046826|NCT02548052|Drug|GSK2981278 0.8%|GSK2981278 will be supplied as a white to off-white ointment containing GSK2981278A drug substance at a concentration of 0.8%. Approximately 200 microliters of the GSK2981278 0.8% ointment will be applied topically to the assigned test field once daily.
16046827|NCT02548052|Drug|GSK2981278 4%|GSK2981278 will be supplied as a white to off-white ointment containing GSK2981278A drug substance at a concentration of 4%. Approximately 200 microliters of the 4% ointment will be applied topically to the assigned test field once daily.
16046828|NCT02548052|Drug|Vehicle|GSK2981278 vehicle will be supplied as a white to off-white ointment containing no drug substance. Approximately 200 microliters of the vehicle will be applied topically to the assigned test field once daily.
16046829|NCT02548052|Drug|Betamethasone valerate 0.1%|Betamethasone valerate will be supplied as a cream. Approximately 200 microliters of the 0.1% betamethasone valerate cream will be applied topically to the assigned test field once daily.
16046830|NCT02548026|Behavioral|High Eating Frequency (High EF)|Free-living participants complete a 21-day high eating frequency (high EF) Phase in which they consume all daily energy at 8 eating occasions.
16046831|NCT02548026|Behavioral|Low Eating Frequency (Low EF)|Free-living participants complete a 21-day low eating frequency (low EF) Phase in which they consume all daily energy at 3 eating occasions.
16046832|NCT02548013|Other|outpatient management|patients if stable will be discharged to continue treatment at home
16046833|NCT02548013|Other|Inpatient management|patients will continue there treatment in hospital till delivery
16046834|NCT02548000|Other|Resistance training|The resistance training will be compound by 12 exercises for all body muscles, performed three times per week. The intensity of training will be measure by maximum repetitions from 12 until 8 repetitions with 2-3 series. The loads will increase for keep the maximum strength as the capacity of patients. The blood pressure and the casual glycemic will be measure before and after the training in each session. Before to start the exercises, patients will perform a warming on treadmill for 10 minutes and after the training will perform some stretching exercises for muscles groups trained.
16046835|NCT02548000|Other|Stretching control|The stretching session will be composed by stretching and joint mobilization exercises for all body muscles and will happen only one time per week.
16046836|NCT02547987|Drug|Docetaxel|Docetaxel 75 mg/m2 intravenously on day 1 of each 21-day cycle. Number of Cycles: 6
16046837|NCT02547987|Drug|Carboplatin|Carboplatin AUC 6 intravenously on day 1 of each 21-day cycle. Number of Cycles: 6
16046838|NCT02547974|Biological|Formulation 1 (plain): NTHi/Mcat vaccine GSK3277513A|2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule
16046839|NCT02547974|Biological|Formulation 2 (adjuvanted): NTHi/Mcat vaccine GSK3277513A|2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule
16046840|NCT02547974|Biological|Formulation 3 (adjuvanted): NTHi/Mcat vaccine GSK3339036A|2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule
16046841|NCT02547974|Drug|Placebo|2 doses at Day 0 and Day 60, Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule
16046842|NCT02547961|Biological|HER-2-targeting CAR T Cells infusion|HER-2-targeting CAR t cells infusion in breast cancer
16046843|NCT02547948|Biological|CD19-targeting CAR T Cells infusion|CD19-targeting 2nd generation CAR t cells infusion for refractory B cell lymphoma
16046844|NCT02547935|Drug|Dapagliflozin 10 mg|Tablets administered orally once daily for 24 weeks.
16046845|NCT02547935|Drug|Saxagliptin 2.5 mg|Tablets administered orally once daily for 24 weeks.
16046846|NCT02547935|Drug|Matching Placebo for Dapagliflozin 10 mg and Saxagliptin 2.5mg|Tablets administered orally once daily for 24 weeks.
16046847|NCT02547922|Biological|Anifrolumab|Administration every 4 week from Week 0 to Week 100 in addition to SOC which will continue until Week 112
16046848|NCT02547922|Drug|Placebo|Administration every 4 week from Week 0 to Week 100 in addition to SOC which will continue until Week 112
16046849|NCT02547909|Procedure|probe-based Confocal Laser Endomicroscopy|"Eligible women will be offered to undergo pCLE examination. Conscious sedation will be offered to all patients, who will choose to receive it or not. pCLE will be done using a standard gastroscope, reaching a distance of 25 cm from the anus, to the level of the rectosigmoid angle.
~At this point, 2.5 ml fluorescein 10% will be injected. The pCLE probe (GastroFlex-UHD probe, Mauna Kea tech, Paris, France) will be inserted through the endoscope working channel and images will be recorded from areas suspected of harboring an endometriotic tissue."
16046850|NCT02547909|Device|Cellvizio|
16046851|NCT02547909|Drug|fluorescein 10%|
16046852|NCT02547896|Drug|Codeine + Diclofenac|The patients will receive codeine and diclofenac as pain relief medicine after the surgery
16046853|NCT02547896|Drug|Diclofenac|The patients will receive only diclofenac
16046854|NCT02547883|Drug|Cessation of statin|The intervention evaluated is the cessation of statin
16046855|NCT02547870|Drug|Rilpivirine (RPV)|Participants will receive one oral tablet of rilpivirine 25 milligram (mg) once on Day 1 of session 1.
16046856|NCT02547870|Drug|Rilpivirine Long-Acting Parenteral Formulation (RPV-LA)|Participants will receive one intramuscular (IM) injection of rilpivirine long-acting parenteral formulation 600 mg once on day 1 of session 2.
16046857|NCT02547870|Drug|Aged RPV-LA|Participants will receive one intramuscular (IM) injection of aged rilpivirine long-acting parenteral formulation 600 mg once on day 1 of session 2.
16046858|NCT02547857|Other|Pelvic US|To be eligible for inclusion, a woman will have pelvic US completed as part of her ED stay. This is a non-interventional study.
16046859|NCT02547844|Drug|efavirenz + emtricitabina + tenofovir|
16046860|NCT02547844|Drug|rilpivirina + emtricitabina + tenofovir|
16046861|NCT02547831|Other|Observational approach|Patients will be placed under wait and see approach without any specific treatment
16046862|NCT02547818|Drug|ALZT-OP1a|1) Mast cell stabilizer, 2) Neuroinflammatory microglial modulator, 3) A-beta oligomerization inhibitor, and 4) anti-inflammatory
16046863|NCT02547818|Drug|ALZT-OP1b|Anti-inflammatory
16046864|NCT02547818|Other|Placebo ALZT-OP1a|Non-active capsules
16046865|NCT02547818|Other|Placebo ALZT-OP1b|Non-active tablets
16046866|NCT02547805|Drug|ALLN-177|ALLN-177 7,500 units (5 capsules) PO TID with meals
16046867|NCT02547805|Drug|Placebo|Placebo 5 capsules PO TID with meals
16046868|NCT02547792|Biological|VXA-BYW.10 (Low Dose) Oral Vaccine|Enteric coated tablet for oral delivery
16046869|NCT02547792|Biological|VXA-BYW.10 (High Dose) Oral Vaccine|Enteric coated tablet for oral delivery
16046870|NCT02547792|Other|Placebo Tablets|Enteric coated tablet for oral delivery
16046871|NCT02547779|Other|0.9% Saline|0.9% Saline will be used whenever an isotonic crystalloid is ordered
16046872|NCT02547779|Other|Physiologically-balanced isotonic crystalloid|Lactated Ringers or Plasma-Lyte© A will be used whenever an isotonic crystalloid is ordered
16046873|NCT02547766|Drug|Anakinra|Anakinra is an Interleukin-1 receptor antagonist that will be given to the patient via subcutaneous injection for a period of 14 consecutive days.
16046874|NCT02547727|Biological|rabies vaccine|Rabies vaccine is injected according to the protocol then blood would be drawn for rabies neutralizing antibody, OX-40 assay and cytokines assessment on day 0,7,14.
16046875|NCT02547714|Drug|Secukinumab (AIN457)|Secukinumab was supplied as 150 mg doses, provided in 1 mL prefilled syringes.
16046876|NCT02547701|Drug|P-3058|
16046877|NCT02547688|Device|Nasal High Flow|
16046878|NCT02547675|Drug|Rociletinib|Rociletinib will be administered to patients orally
16046879|NCT02547662|Drug|Dexamethasone|Given PO
16046880|NCT02547662|Drug|Ixazomib Citrate|Given PO
16046881|NCT02547662|Other|Laboratory Biomarker Analysis|Correlative studies
16046882|NCT02547662|Drug|Pomalidomide|Given PO
16046883|NCT02547649|Biological|V114-A|Formulation A of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-A uses a unique excipient to improve stability of the vaccine against physical stress).
16046884|NCT02547649|Biological|V114-B|Formulation B of V114 contains 2 µg of pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, and 33F; 4 µg of serotype 6B; 32 µg of CRM197 protein carrier; and 125 µg of Aluminum Phosphate Adjuvant in each 0.5 mL dose (V114-B uses a unique excipient to improve stability of the vaccine against physical stress).
16046885|NCT02547649|Biological|Prevnar 13®|Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each), and 6B (4.4 mcg) in each 0.5 mL dose.
16046886|NCT02547636|Other|Observational study|No intervention will be used in this study.
16046887|NCT02547623|Drug|Dexamethasone|depot intracameral
16046888|NCT02547623|Drug|Prednisolone|Prednisolone eye drops 1%
16046889|NCT02547610|Device|The imaging biomarkers determined by MR-PET|Combining PET and MRI, namely MR/PET, has the benefit of evaluating tissue metabolism with PET and at the same time evaluating tissue morphology/functional information with MR.
16046890|NCT02547597|Drug|Carvedilol|
16046891|NCT02547597|Drug|Atenolol|
16046892|NCT02547584|Procedure|Catheter ablation|Pulmonary vein antrum isolation (PVAI) plus entire posterior wall plus coronary sinus plus left part of the septum. This intervention will be received by all as standard of care
16046893|NCT02547571|Drug|High volume PEG split-dose|Colyte® or PegLyte® will be provided to the subject who will be asked to drink 2L of the preparation starting at 7:00 PM the day before the procedure at a rate of 240 mL every 10 minutes until completed. The second dose of 2L of preparation will be taken the morning of the colonoscopy starting 4-5 hours prior to the planned procedural time at a rate of 240 mL every 10 minutes until completed.
16046894|NCT02547571|Drug|Low volume PEG split-dose|Bi-PegLyte® will be provided to the subject who will be asked to ingest 3 tabs of Bisacodyl 5 mg (total 15 mg) at 2:00 PM the day before the procedure. After the first bowel movement, or if there is no bowel movement within 6 hours of taking the Bisacodyl tablets, the subject will be asked to drink 1L of the solution at a rate of 240 mL every 10 minutes until the solution is completed. The second dose of 1L of preparation will be taken the morning of the colonoscopy starting 4-5 hours prior to the procedure at a rate of 240 mL every 10 minutes. Use of antacids will not be permitted within one hour of taking bisacodyl.
16046895|NCT02547571|Drug|High volume PEG non split, day before|Colyte® or PegLyte® will be provided to the subject who will be asked to drink 4L of preparation starting at 6:00 PM the day before the procedure, at a rate of 240 mL every 10 minutes until completed.
16046896|NCT02547571|Drug|Low volume PEG non split, same day|Bi-PegLyte® will be provided to the subject, who will be asked to ingest 3 tabs of Bisacodyl 5 mg (total 15 mg) at 2:00 PM the day before the procedure and will drink 2L of preparation the morning of the colonoscopy starting 4 hours prior to the procedure at a rate of 240 mL every 10 minutes, until completed. Use of antacids will not be permitted within one hour of taking Bisacodyl.
16046897|NCT02547571|Other|Clear liquid diet|
16046898|NCT02547571|Other|Low residue diet|
16046899|NCT02547571|Other|Early colonoscopy (stratified)|"Early appointments: 7:30 AM to 10h30 AM"
16046900|NCT02547571|Other|Later colonoscopy (stratified)|"Later appointments: 10:30 AM to 4:30 PM."
16046901|NCT02547558|Procedure|Arterial blood gases|Measured through radial arterial catheter
16046902|NCT02547558|Procedure|Cardiac Output|Measured through bioimpedance: FloTrac pressure transducer (FloTrac sensor; Edwards Lifesciences) using the third-generation (3.01) FloTrac software for continuous CO display.
16046903|NCT02547558|Procedure|Vital signs|As measured in clinical practice
16046904|NCT02547558|Procedure|Exhaled breath|Were recorded using a pneumotachograph (CPX/D; Med Graphics, St. Paul, MN, U.S.A.).
16046905|NCT02547558|Procedure|Spirometry|In a daily calibrated spirometer.
16046906|NCT02547558|Drug|Indacaterol|Indacaterol Breezhaler@ 300 mcg (1 inhalation)
16046907|NCT02547532|Other|collection of sputum|
16046908|NCT02547519|Drug|Oral Insulin|Total of 12 months treatment; dose escalation scheme: daily treatment with 7.5 mg or placebo for 3 months; increasing to daily treatment with 22.5 mg or placebo for the following 3 months; increasing to daily treatment with 67.5 mg or placebo for the last 6 months of the treatment period.
16046909|NCT02547519|Drug|Placebo|Total of 12 months treatment; daily treatment with insulin or placebo capsules containing filling substance (microcrystalline cellulose).
16046910|NCT02547493|Biological|pneumococcal polysaccharide vaccine|Vaccination with PPSV on first day. NB : PPSV vaccine Pneumo23 has been replaced in September 2017 by the equivalent vaccine Pneumovax because of the stop of commercialization of Pneumo23 in France by the pharmaceutical company.
16046911|NCT02547493|Biological|pneumococcal conjugate vaccine|Patients are vaccinated with Prevenar13 on the first day, and with Pneumo23/Pneumovax two months later.
16046912|NCT02547493|Drug|Abatacept|Abatacept started on frst day
16046913|NCT02547480|Device|TACE with irinotecan loaded LifePearl|Arterial embolization will be performed through lobar infusion and using a microcatheter. LifePearl microspheres of 200 µm will be used as preferred beads. They will be loaded with the appropriate dose of irinotecan hydrochloride injectable solution, mixed with the contrast media and distributed to the targeted lobe. The targeted dose is 100 mg of irinotecan per lobe treated, meaning that when treated unilobarly at baseline the total dose received will be 100 mg ( all in one lobe) and in during bilobar treatment, 200 mg in both lobes.
16046914|NCT02547467|Other|epidemiologic study|There is no intervention as it is a pure observational study for epidemiologic survey.
16046915|NCT02547454|Drug|Methoxy polyethylene glycol-epoetin beta|
16046916|NCT02547441|Drug|CLS001 (Omiganan)|Topical gel
16046917|NCT02547441|Drug|Vehicle|Vehicle Gel
16046918|NCT02547428|Drug|CTN SR|Participants will receive CTN SR tablets in a 100-mg dose strength, designed for twice-daily (BID) oral (PO) administration.
16046919|NCT02547428|Drug|Placebo|Participants will receive CTN SR matching placebo tablets, orally twice daily, titrated in the same manner as CTN SR to protect the blind.
16046920|NCT02547415|Other|questionnaires and psychological testing|"Child/adolescent and parents interview and consultation with both a physician and a psychologist for a somatic and pain indicators assessment within an usual setting.
~Then, parents and child or adolescent are interviewed separately using different psychological instruments with only a psychologist:
~Psychological (cognitive and projective evaluation) : Intellectual Quotient, mental flexibility, projective evaluation with Rorschach and Thematic Apperception Test, parents and children attachment questionnaires
~Psychopathological: anxiety and depression questionnaires, psychiatric disorders evaluation, quality of life, life events questionnaires, family functioning interview."
16046921|NCT02547402|Drug|CXA-10|CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitrated oleic acid
16046922|NCT02547402|Drug|pravastatin|It is statin medicine used to lower cholesterol and triglycerides in the blood.
16046923|NCT02547402|Drug|Vytorin® (combination of simvastatin and ezetimibe)|It lowers bad cholesterol in the blood, and raises good cholesterol
16046924|NCT02547389|Behavioral|Community support group|
16046925|NCT02547389|Other|Printed material Supported|
16046926|NCT02547363|Drug|LEO 43204 gel|
16046927|NCT02547363|Drug|Vehicle gel|
16046928|NCT02547350|Drug|pharmorubicin or pirarubicin|pharmorubicin 50mg pirarubicin 30mg
16046929|NCT02547324|Radiation|Slump sitting|Patients are asked to sit slumped on the chair as much as possible without leaning forwards, and place you hands below your thighs.
16046930|NCT02547324|Radiation|Forward bending|Patients are asked to stand with both feet placed together, hands behind their heads, and bend forward in this position as much as possible without falling
16046931|NCT02547311|Behavioral|Team Clinic|
16046932|NCT02547298|Procedure|Hydrodistension|Patients who are already scheduled to have a gynecologic, urologic or uro-gynecologic procedure involving cystoscopy if consented will have hydrodistension performed
16046933|NCT02547298|Device|Cystoscopy|
16046934|NCT02547285|Other|Shoes characteristics|A single parameter of shoe vary for each test (Different insole, heel height, stem length ...)
16046935|NCT02547272|Procedure|Nasal and rectal bacterial samples|Bacterial nasal and rectal samples at admission and one weekly for the presence of S Aureus
16046936|NCT02547259|Procedure|pain words test|"words to painful sense will be shown on a screen, one at a time for 5 seconds. Patient or healthy volunteer will need to retain them. Then these same words, mixed with others that patient/healthy volunteer will not learn, will again be displayed on the computer screen one at a time for 5 seconds. Upon the occurrence of a word, patient/healthy volunteer must press the 'L' key if they think they have learned the word or the D key on the keyboard if they feel that they have not learned this word."
16046937|NCT02547259|Procedure|negative words test|"words to negative sense will be shown on a screen, one at a time for 5 seconds. Patient or healthy volunteer need to retain them. Then these same words, mixed with others that patient/healthy volunteer will not learn, will again be displayed on the computer screen one at a time for 5 seconds. Upon the occurrence of a word, patient/healthy volunteer must press the 'L' key if they think they have learned the word or the D key on the keyboard if they feel that they have not learned this word."
16046938|NCT02547246|Device|rTMS session|One session of rTMS at a frequency of 10 Hz during 20 minutes
16046939|NCT02547246|Device|rTMS Placebo (SHAM)|One session of placebo (SHAM) rTMS during 20 minutes
16046940|NCT02547233|Drug|LEO 43204 gel|
16046941|NCT02547233|Drug|Vehicle gel|
16046942|NCT02547220|Biological|Cinryze®|Participants will receive 5000 Units of CINRYZE (50 millilitre [mL] of CINRYZE/ 50 mL of normal saline) on Day 1 and 2500 Units of CINRYZE (25 mL of CINRYZE/ 75 mL of normal saline) on Day 3, 5, 7, 9, 11, and 13 respectively.
16046943|NCT02547220|Drug|Placebo|Participants will receive 7 doses of matched placebo over 13 days of treatment.
16046944|NCT02547181|Behavioral|Behavioral Modification|Patient will be provided with tensor bandage and instructed on specific behaviors to prevent movement of the injured part of the hand.
16046945|NCT02547181|Behavioral|Splint|fibreglass splint
16046946|NCT02547168|Device|iRhythm ZIO XT patch|The iRhythm ZIO XT patch is an ECG monitor that has to be worn by study participants. It will be used to track any incidence of atrial fibrillation.
16046947|NCT02547155|Procedure|Spinal anesthesia|8-12.5 mg of bupivacaine will be administered for spinal anesthesia
16046948|NCT02547155|Procedure|General anesthesia|propofol induction, in combination with a muscle relaxant and inhalational gas
16046949|NCT02547142|Other|Early Palliative Care|Metastatic esophageal cancer patients that receive early palliative care along with standard oncological care
16046950|NCT02547129|Device|Static Antibiotic Spacer Surgical Implant|Joint spacer for treatment of joint infection
16046951|NCT02547129|Device|Articulating Antibiotic Spacer Surgical Implant|Joint spacer for treatment of joint infection
16046952|NCT02547116|Drug|Rifampin|Addition of Rifampin to standard anti-Staphylococcal treatment regimen
16046953|NCT02547103|Other|Chlorhexidine gluconate-soaked cloths|
16046954|NCT02547103|Other|Normal saline|
16046955|NCT02547103|Other|mupirocin ointment|
16046956|NCT02547090|Procedure|The use of two attending surgeons during posterior spinal fusion|Patients in the experimental group received posterior spinal fusion with two attending surgeons. Patients in the control group received posterior spinal fusion with one attending surgeon and one first assist, which could be a resident, PA, or nurse.
16046957|NCT02547077|Procedure|Wound Closure with 2-octylcyanoacrylate|
16046958|NCT02547077|Procedure|Wound Closure with 5-0 Fast Absorbing Gut Sutures|
16046959|NCT02547064|Procedure|Glidescope guided intubation|
16046960|NCT02547064|Device|GlideScope®|
16046961|NCT02547051|Other|Food Allergy Testing and Elimination Diet|Food allergy testing and elimination diet
16046962|NCT02547038|Drug|pantoprazole+bismuth+tetra+metro|pantoprazole 40 mg twice daily, bismuth subcitrate 120 mg four times daily, and tetracycline 500 mg four times daily, and metronidazole 250 mg four times daily for 14 days
16046963|NCT02547038|Drug|(panto+amox+clar+metr)+(panto+amox)|a 7-day quadruple regimen with pantoprazole 40 mg twice daily, amoxicillin 1 g twice daily, clarithromycin 500 mg twice daily, and metronidazole 500 mg twice daily, followed by a 7-day dual regimen with pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily
16046964|NCT02547025|Drug|rabeprazole+3 antibiotics|(rabeprazole 20 mg q.d.s. and three effective antibiotics) for 14 days.
16046965|NCT02547025|Drug|rabeprazole+bismuth+2 antibiotics|(rabeprazole 20 mg q.d.s., bismuth subcitrate 120 mg q.d.s. and all the effective antibiotics) for 14 days.
16046966|NCT02547025|Drug|rabeprazole+amox+tetr+levo|(rabeprazole 20 mg q.d.s, amoxicillin 500 mg q.d.s., tetracycline 500 mg q.d.s. and levofloxacin 500 mg o.d.) for 14 days.
16046967|NCT02547012|Drug|esomeprazole+amox+levo+tetra|esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d., and tetracycline 500 mg q.d.s.
16046968|NCT02547012|Drug|esomeprazole+amox+levo|esomeprazole 40 mg b.d., amoxicillin 500 mg q.d.s., levofloxacin 500 mg o.d.,
16046969|NCT02546999|Drug|botox|The agent will be given only once at point zero in the time scheme for the project.
16046970|NCT02546999|Drug|placebo|The agent will be given only once at point zero in the time scheme for the project.
16046971|NCT02546986|Drug|CC-486|CC-486 will be administered orally at a dose of 300 mg daily on days 1-14 of each 21-day cycle.
16046972|NCT02546986|Drug|Pembrolizumab|Pembrolizumab will be administered as a 30-minute IV infusion on day 1 of each 21-day cycle.
16046973|NCT02546986|Drug|Placebo|Placebo will be administered orally daily on days 1-14 of each 21-day cycle.
16046974|NCT02546960|Biological|ExPEC4V (4 : 4 : 4 : 4)|Participants will receive single vaccination of ExPEC4V dose (4 : 4 : 4 : 4) as an intramuscular (i.m) injection into deltoid muscle in part 1 (age groups >=18 to <50 years and >=50 years) and part 2 (based on review of safety data by the IDMC). The ExPEC4V doses contain polysaccharide antigen (in microgram [mcg]) from the ExPEC serotypes O1A, O2, O6A, and O25B.
16046975|NCT02546960|Biological|ExPEC4V (4 : 4 : 4 : 8)|Participants will receive single vaccination of ExPEC4V dose (4 : 4 : 4 : 8) as an i.m injection into deltoid muscle in part 1 (age groups >=18 to <50 years and >=50 years) and part 2 (based on review of safety data by the IDMC). The ExPEC4V doses contain polysaccharide antigen (in mcg) from the ExPEC serotypes O1A, O2, O6A, and O25B.
16046976|NCT02546960|Biological|ExPEC4V (8 : 8 : 8 : 8)|Participants will receive single vaccination of ExPEC4V dose (8 : 8 : 8 : 8) as an i.m injection into deltoid muscle in part 1 (age groups >=18 to <50 years and >=50 years) and part 2 (based on review of safety data by the IDMC). The ExPEC4V doses contain polysaccharide antigen (in mcg) from the ExPEC serotypes O1A, O2, O6A, and O25B.
16046977|NCT02546960|Biological|ExPEC4V (8 : 8 : 8 : 16)|Participants will receive single vaccination of ExPEC4V dose (8 : 8 : 8 : 16) as an i.m injection into deltoid muscle in part 1 (age groups >=18 to <50 years and >=50 years) and part 2 (based on review of safety data by the IDMC). The ExPEC4V doses contain polysaccharide antigen (in mcg) from the ExPEC serotypes O1A, O2, O6A, and O25B.
16046978|NCT02546960|Biological|ExPEC4V (16 : 16 : 16 : 16)|Participants will receive single vaccination of ExPEC4V dose (16 : 16 : 16 : 16) as an i.m injection into deltoid muscle in part 1 (age groups >=18 to <50 years and >=50 years) and part 2 (based on review of safety data by the IDMC). The ExPEC4V doses contain polysaccharide antigen (in mcg) from the ExPEC serotypes O1A, O2, O6A, and O25B.
16046979|NCT02546960|Drug|Placebo|Participants will receive matching placebo (Tris-buffered saline) to ExPEC4V.
16046980|NCT02546947|Other|Train of four monitoring|with an end point of one or two response at orbicularis oculi to TOF stimulation
16046981|NCT02546934|Drug|ABX, cisplatin|ABX 125 mg/m2, IV drip 30 minutes, D1, D8 Cisplatin 75 mg/m2, IV drip 120 minutes, D1
16046982|NCT02546934|Drug|Gemcitabine, Cisplatin|Gemcitabine 1250 mg/m2, IV drip 30 minutes, D1, D8 Cisplatin 75 mg/m2, IV drip 120 minutes, D1
16047060|NCT02546427|Radiation|HDR brachytherapy|
16047271|NCT02544893|Drug|dexmedetomidin|1 ml dexmedetomidin + 20 ml 0.5 % bupivacaine are applied paravertebral space
16046984|NCT02546908|Other|No Intervention|This is an observational study. No study medication is provided will be provided as part of participation. Participants disease status, overall survival (OS), PFS, MFS, SRE-free survival, and time to castration (TTC) will be analyzed according to treatments prescribed while enrolled in the registry. All treatment decisions will be made at the discretion of the investigator or treating physician.
16046985|NCT02546895|Other|chart review|"The patient charts will be reviewed to determine pretreatment characteristics, treatment-related adverse events, time to progression and overall survival.
~Behavioral: Questionnaires Completion of 3 questionnaires 1 week before treatment(radiotherapy or chemotherapy) begins or been hospitalized for surgery the same day, 1 week after the end of treatment(expected average of 8 weeks), and again 3 months after treatment. It may take about 30 minutes to complete the questionnaires each time."
16046986|NCT02546882|Biological|stromal vascular fraction|1million stromal vascular fraction was resuspended in 1 ml saline and transplanted for 1 cm2 area.
16046987|NCT02546882|Drug|saline|1 ml saline was injected for 1 cm2 area.
16046988|NCT02546869|Drug|Lebrikizumab|Lebrikizumab will be administered SC using PFS, q4w up to Week 12.
16046989|NCT02546869|Device|Prefilled Syringes|
16046990|NCT02546856|Other|Heart Failure (HF) nurse up-titration|"Up-titration of Beta-Blocker (BB), Angiotensin Converting Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blocker (ARB) and Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure De Novo patients with Left Ventricular Ejection Fraction (LVEF)≤ 40%, following a protocol based on 2012 European Society of Cardiology (ESC) Heart Failure (HF) guidelines with cardiologist prescription and support."
16046991|NCT02546856|Other|Heart Failure (HF) cardiologist up-titration|"Up-titration of Beta-Blocker (BB), Angiotensin Converting Enzyme Inhibitor (ACEI), Angiotensin II Receptor Blocker (ARB) and Mineralocorticoid Receptor Antagonist (MRA) in Heart Failure De Novo patients with Left Ventricular Ejection Fraction (LVEF)≤ 40%, following a protocol based on 2012 European Society of Cardiology (ESC) Heart Failure (HF) guidelines. Drugs are prescribed and titrated by the cardiologist."
16046992|NCT02546843|Drug|Rocuronium|rocuronium 0.6 mg/kg intravenously (1 mg/kg only in a case of a rapid sequence induction)
16046993|NCT02546843|Drug|Cisatracurium|cisatracurium 0.15mg/kg intravenously
16046994|NCT02546843|Drug|Nonspecific Neuromuscular Blockade reversal|neostigmine 0.03 mg/kg and atropine 0.02 mg/kg intravenously
16046995|NCT02546843|Drug|Specific Neuromuscular Blockade reversal|Sugammadex intravenously aimed to reverse the neuromuscular blockade.According to neuromuscular blockade monitoring: at TOF - (train-of-four) 2m g/kg, if TOF 0 and PTC(post-tetanic count) 0-1 4mg/kg of sugammadex will be administered
16046996|NCT02546843|Drug|maintaining the depth of neuromuscular blockade - rocuronium|repeated boluses of rocuronium 0.3 mg/kg will be administered to maintain the muscular blockage - according to TOF 0, PTC 0-1
16046997|NCT02546843|Drug|maintaining the depth of neuromuscular blockade - cisatracurium|repeated boluses of cisatracurium 0.03 mg/kg will be administered to maintain the muscular blockage - according to TOFmaintaining of muscular relaxation TOF 1
16046998|NCT02546830|Device|FreeO2 v2.2 active|"Automatic adjustment of oxygen through the Free O2 device.
~FreeO2 device in mode medical data collecting(SpO2,EtCO2...)."
16046999|NCT02546830|Device|FreeO2 v2.2 with manual oxygenation|"Manual adjustment of oxygen without the assistance of the FreeO2 device.
~Only FreeO2 device in mode medical data collecting(SpO2,EtCO2...)."
16047000|NCT02546804|Procedure|HOT SALT WATER|25ml mouthwash will be rinsed for 60sec), twice daily for 60 days The subjects then will be recalled for measuring the data's after 2weeks, 4weeks, 6weeks and 8weeks.
16047001|NCT02546804|Procedure|POTASSIUM PERMANGANATE|10ml mouthwash will be rinsed for 60sec), twice daily for 60 days The subjects then will be recalled for measuring the data's after 2weeks, 4weeks, 6weeks and 8weeks.
16047002|NCT02546804|Procedure|CHLORHEXIDINE|10ml mouthwash will be rinsed for 60sec), twice daily for 60 days The subjects then will be recalled for measuring the data's after 2weeks, 4weeks, 6weeks and 8weeks.
16047003|NCT02546791|Drug|Dasatinib|
16047004|NCT02546778|Device|Dermosux RF|The radio frequency was used for 20 min in the abdomen and flanks, once per week for 7 weeks.
16047005|NCT02546765|Drug|IV acetaminophen & IV propofol|use of IV tylenol and IV propofol for pain and sedation (respectively)
16047006|NCT02546765|Drug|IV acetaminophen & IV dexmedetomidine|use of IV tylenol and IV dexmedetomidine for pain and sedation (respectively)
16047007|NCT02546765|Drug|IV propofol & placebo|use of IV propofol for sedation and morphine, the drug of choice for cardiac pain
16047008|NCT02546765|Drug|IV dexmedetomidine & placebo|use of IV dexmedetomidine for sedation and morphine, the drug of choice for cardiac pain
16047009|NCT02546752|Other|THEO|THEO is interactive patient engagement software that runs on an iPad tablet platform (developed by Noble.MD). THEO is the intervention in this study.
16047010|NCT02546739|Biological|Anti-CD19-CAR|Cells extracted, followed by induction chemotherapy before CD19-CAR infusion (dose escalation.)
16047011|NCT02546726|Behavioral|Heat & Aerobic Training (HEAT)|Participants receive 42 supervised 50-minute, moderately intensive (50-75% max HR) aerobic exercise sessions (3 times per week), followed by 11-20 minutes of post-exercise steam-room therapy. Participants are encouraged to exercise on their own (e.g., 1-2 days of aerobic and/or resistance training) but to refrain from unsupervised steam-room sessions or any other form of heat therapy.
16047012|NCT02546726|Behavioral|Exercise Only|Participants receive 42 supervised 50-minute, moderately intensive (50-75% max HR) aerobic exercise sessions (3 times per week), followed by 11-20 minutes of post-exercise sitting in the lobby of the fitness facility. Participants are encouraged to exercise on their own (e.g., 1-2 days of aerobic and/or resistance training) but to refrain from unsupervised steam-room sessions or any other form of heat therapy.
16047013|NCT02546713|Other|Abutment with concave subcritical contour|Implants will be restored with abutments with concave configuration of the subcritical contour
16047014|NCT02546713|Other|Abutment with convex subcritical contour|Implants will be restored with abutments with convex configuration of the subcritical contour
16047015|NCT02546700|Drug|Lebrikizumab|Lebrikizumab 125 milligrams (mg) will be administered subcutaneously once in every 4 weeks.
16047016|NCT02546700|Drug|Placebo|Matching placebo will be administered subcutaneously once in every 4 weeks.
16047148|NCT02545790|Biological|Serology|protein analysis targeting several potential protein biomarkers for cardiac remodeling and hypertrophy as well as targeting known miRNAs.
16047017|NCT02546687|Other|Venous blood sampling|"The investigators will take 1-2 cc of venous blood from proximal part of stomach before gastric tube creation and in the same time the investigators will take same amount of venous blood from peripheral vein. This blood will be analyzed in the ABL800 FLEX blood gas analyzer as a routine blood analyses that making by anesthesiologist during the operation. This blood sampling the investigators will make again after 15-30 minutes from the same area in proximal stomach (after creation of gastric tube) and peripheral vein just before anastomosis creation. The investigators will measure components of venous blood gases (O2, pH, CO2, lactate) from the area of future anastomosis before construction of gastric tube and just before creation of anastomosis ( after 15-30 minutes), compare the results of this analysis with systemic venous blood."
16047018|NCT02546674|Drug|Nilotinib|Nilotinib will be prescribed by the investigator according to the patient's medical need.
16047019|NCT02546661|Drug|AZD4547|AZD4547 Monotherapy vs. MEDI4736 (durvalumab) + AZD4547 1:1 Randomization.
16047020|NCT02546661|Drug|MEDI4736|MEDI4736
16047021|NCT02546661|Drug|Olaparib|MEDI4736 (durvalumab) + Olaparib
16047022|NCT02546661|Drug|AZD1775|MEDI4736 (durvalumab) + AZD1775
16047023|NCT02546661|Drug|Vistusertib|MEDI4736 (durvalumab) + Vistusertib
16047024|NCT02546661|Drug|AZD9150|MEDI4736 (durvalumab) + AZD9150
16047025|NCT02546661|Drug|Selumetinib|MEDI4736 (durvalumab) + Selumetinib
16047026|NCT02546648|Drug|Tranexamic Acid|
16047027|NCT02546648|Drug|Tranexamic Acid Placebo|
16047028|NCT02546648|Drug|Rosuvastatin or matching placebo|Subjects who are not on a statin will also be randomized to Rosuvastatin or Rosuvastatin placebo. 40mg preoperatively, followed by 20mg postoperatively (4-6 hours after surgical close) and 20mg/day for 30 days postoperatively.
16047029|NCT02546635|Drug|AX-024.HCl|AX-024.HCl will be administered as per the protocol defined frequency and dose level
16047030|NCT02546635|Drug|AX-024.HCl|AX-024.HCl will be administered as per the protocol defined frequency and dose level
16047031|NCT02546622|Biological|Factor VIII Replacement Products for Hemophilia which were FDA approved after January 1, 2013|Prophylaxis for prevention of bleeding, various regimens.
16047032|NCT02546622|Biological|Factor IX Replacement Products for Hemophilia which were FDA approved after January 1, 2013|Prophylaxis for prevention of bleeding, various regimens.
16047033|NCT02546609|Drug|Leu-Met-Sil 0.5|NS-0200 low dose
16047034|NCT02546609|Drug|Leu-Met-Sil 1.0|NS-200 high dose
16047035|NCT02546609|Drug|Placebo|Placebo
16047036|NCT02546596|Device|Electro-hyperthermia|Addition of electro-hyperthermia to radiation
16047037|NCT02546583|Drug|Increased Intravenous Bolus Loop Diuretic Dose (Bumetanide or Furosemide)|An increase to 2.5x the Visit 1 dose of loop diuretic (bumetanide or furosemide).
16047038|NCT02546583|Drug|IV Chlorothiazide|
16047039|NCT02546570|Drug|Oxytocin|See arm/group descriptions for dosage amount and procedure.
16047040|NCT02546570|Drug|Placebo|See arm/group descriptions for dosage amount and procedure.
16047041|NCT02546557|Procedure|Coronary Artery Bypass Graft surgery|
16047042|NCT02546544|Drug|Linsitinib|
16047043|NCT02546531|Biological|Defactinib|
16047044|NCT02546531|Biological|Pembrolizumab|
16047045|NCT02546531|Drug|Gemcitabine|
16047046|NCT02546518|Device|Moniri Otovent|Please see Arm Description.
16047047|NCT02546518|Device|Tympanostomy tube in the ear drum|Insertion of tympanostomy tube/Grommet in the ear drums.
16047048|NCT02546505|Other|Front-of-pack nutrition labeling|Introduction of a Front-of-pack nutrition label (5-CNL) on selected categories of foods.
16047049|NCT02546505|Other|Consumer information|Information specifically targeting nutritional information and explaining the 5-CNL is presented to the subject (this information will consist in a concept shown to respondents before the shopping session).
16047050|NCT02546492|Drug|Acthar gel|Administration of the study drug in addition to the current maintenance immunosuppressive agents
16047051|NCT02546466|Procedure|Functional Star-shape taping (SFT)|For the SFT procedure, four tapes will be applied in the form of an elastic ''I'' with the aim of facilitating muscle activation. The taping will be applied when the participant is in a seated position. The taping will be positioned covering the entire lumbar region and lower part of the thoracic region (T11, T12), and placed first at the center and then on the ends (Castro-Sanchez et al. 2012).The tension of the taping was 25%, this protocol being recommended by the Kinesio taping manual to facilitate muscle activation (Castro-Sanchez et al. 2012; Kase et al. 2003). The participant will remain for on week with FT.
16047052|NCT02546466|Procedure|Sham Functional Taping (Sham-FT)|For the Sham-FT procedure, a single bandage 20 cm in length was positioned horizontally, passing through the spinous process of the second lumbar vertebra (Castro-Sanchez et al. 2012). The tension of the taping was 25%, this protocol being recommended by the Kinesio taping manual to facilitate muscle activation (Castro-Sanchez et al. 2012; Kase et al. 2003). The participant will remain for on week with FT.
16047053|NCT02546466|Behavioral|Minimal Intervention Strategy (MIS)|The MIS group will receive an educational and counseling booklet (The Back Book) as recommend by Dupeyron et al. (2011) containing information about the low back pain clinical features, risk factors and prognosis, fear avoidance beliefs, how to deal with an acute pain crisis, the early resumption of normal or vocational activities, even when still experiencing pain, and the importance of improvement in functional activity levels and posture, not just pain relief (Delitto et al. 2012). Participants from this group will not receive FT intervention and the investigator will encourage participants to not receive any kind of treatment during the one month epoch after the initial assessment. They will be followed by one of the investigators that will make phone calls to clarify doubts and reinforce the counseling.
16047054|NCT02546453|Biological|Tumoral specific genetic alterations|A buccal swab and a blood sample will be used at the diagnostic to identify the specific genetic alterations of tumoral cells.
16047055|NCT02546453|Biological|Tumoral specific genetic alterations|Collection of blood (maximum 9 samples of 3 to 5 ml), bone marrow (maximum 3 samples of 3 to 5 ml) and cerebral spinal fluid (maximum 3 samples 500µl to 1ml).
16047056|NCT02546440|Drug|dimethylfumarate|dose escalation from 30 mg/d to 720 mg/d over 9 weeks following a preset design in psoriasis treatment in Germany, oral medication in tablet form. Treatment will last 24 weeks or until unacceptable side effects occur
16047057|NCT02546427|Radiation|Helical TomoTherapy (HT)|
16047058|NCT02546427|Radiation|CyberKnife SBRT|
16047061|NCT02546414|Other|Platelet count/spleen diameter ratio|Platelet count were evaluated by complete blood count, and ultrasound was used to measure the longest diameter of the spleen.The platelet count/spleen diameter ratio was calculated
16047062|NCT02546401|Drug|Insulin Aspart|Injection of Insulin Aspart before or after meals
16047063|NCT02546388|Drug|Indium-111 Pentreotide|
16047064|NCT02546388|Drug|Gallium-68 DOTATATE|
16047065|NCT02546375|Drug|Bosutinib|Bosutinib 100mg film-coated tablets; Bosutinib 500mg film-coated tablets Dosage as prescribed at treating institution; (observational study)
16047066|NCT02546362|Device|Cefaly|
16047067|NCT02546349|Drug|fluticasone/salmeterol, tiotropium|In group (either high or low eNO), patients will be randomized to receive either 2 puffs of fluticasone/salmeterol 250/25 mcg/puff twice daily or 2 inhalations of tiotropium respimat 2.5 mcg/inhalation once daily for 12 weeks.
16047068|NCT02546336|Device|Ultrasound-Guided Cooled Radiofrequency Hip Denervation|Light neuroleptic anesthesia and skin preparation will be performed. Under Ultrasound guidance, an active probe will be inserted. Sensory and motor stimulation will be administered. Anteroposterior fluoroscopy image will be recorded. Lesioning of articular branches of femoral and obturator nerves via radiofrequency will be performed after lidocaine injection. WOMAC, EQ-5D and SF-12 questionnaires will be used for measuring outcomes postoperatively.
16047069|NCT02546323|Drug|Rosuvastatin|20mg tablets, orally once daily for the duration of the 104-week treatment period
16047070|NCT02546323|Drug|Placebo|Matching placebo tablets, orally once daily for the duration of the 104-week treatment period.
16047071|NCT02546310|Drug|HTL0009936|
16047072|NCT02546310|Drug|HTL0009936 matching placebo|
16047073|NCT02546297|Drug|Symbicort|drug are used for 12 months
16047074|NCT02546297|Drug|Spiriva|drug are used for 12 months
16047075|NCT02546284|Drug|lenzilumab|
16047076|NCT02546271|Behavioral|GPS|
16047077|NCT02546258|Device|A Fungal Nail Treatment|treats the signs of mild fungal nail infections
16047078|NCT02546245|Behavioral|Heroes of Knowledge|Participants will play their assigned game(s) on a tablet computer for 1-1.5 hours, 2-3 times per week for 2-4 weeks (to accumulate 6-8 hours of gameplay).
16047079|NCT02546245|Behavioral|Attention/Time Control Game|Participants will play their assigned game(s) on a tablet computer for 1-1.5 hours, 2-3 times per week for 2-4 weeks (to accumulate 6-8 hours of gameplay).
16047080|NCT02546232|Drug|Carboplatin|Chemotherapy
16047081|NCT02546232|Drug|Paclitaxel|Chemotherapy
16047082|NCT02546219|Other|Eosinophil isolation and characterization.|Peripheral blood and esophageal biopsies will be obtained from study subjects for further analysis of eosinophils integrin profiles.
16047083|NCT02546206|Dietary Supplement|Probiotic Yoghurt|Probiotic yoghurt consumption
16047084|NCT02546206|Dietary Supplement|Natural Yoghurt|Natural yoghurt consumption
16047085|NCT02546193|Device|Foley catheter|The Foley catheter is a device used to achieve cervical ripening at the start of labor induction. It is a single balloon catheter placed transcervically by a provider, either digitally or using a speculum for visualization. The balloon is placed above the internal os but below the fetal head, amniotic membranes, and placenta and is inflated. In this study, it will be inflated with 60 cc of normal saline and taped to the patient's thigh for traction. Over several hours, the balloon gradually dilates the cervix. The catheter is typically expulsed when the cervix is 3-4 centimeters.
16047086|NCT02546193|Drug|Misoprostol|Misoprostol is a prostaglandin E1 analogue that is used for cervical ripening during labor induction. A 25 microgram tablet is placed in the vagina by a provider. A new 25 mcg tablet can be used vaginally every 4 hours for up to 6 total doses.
16047087|NCT02546180|Other|Viewing YouTube videos|The on-line patient education program will highlight postoperative care.
16047088|NCT02546180|Other|Standard preoperative education|Standard preoperative education will be provided by the surgeon, physician extender and paramedical staff in the clinic.
16047089|NCT02546167|Biological|CART-BCMA|
16047090|NCT02546154|Drug|10% Iron Isomaltoside 1000|Standard clinical practice and following the Monofer® label (SPC)
16047091|NCT02546141|Other|skimmed milk (UHT)|
16047092|NCT02546141|Other|skimmed milk (pasteurized)|
16047093|NCT02546141|Other|skimmed yoghurt|
16047094|NCT02546141|Other|full-fat milk (UHT)|
16047095|NCT02546141|Other|non-homogenized full-fat milk (pasteurized)|
16047096|NCT02546141|Other|full-fat cheese (semi-matured)|
16047097|NCT02546141|Other|whey protein|
16047098|NCT02546141|Other|micellar casein|
16047099|NCT02546128|Device|Extra-Corporeal Shockwave Therapy (ESWT)|The use of ESWT from a commercially available machine at approved settings already in routine clinical use
16047100|NCT02546128|Other|structured rehabilitation programme|a structured and standardised rehabilitation programme specific to the tendon in question - already in routine clinical use
16047101|NCT02546115|Device|tension night splint|this is the use of a commercially available tension night splint device, to be worn by the patient
16047102|NCT02546115|Other|standard practice - a structured rehabilitation programme|this is the standardised structured rehabilitation programme of home exercises given to patients, with supporting literature, and instructions on how to progress the regime themselves
16047103|NCT02546102|Biological|ICT-107|Autologous dendritic cells pulsed with peptides associated with tumor antigens
16047104|NCT02546102|Biological|Placebo|
16047105|NCT02546089|Other|Autologous Blood Injection|ultrasound-guided autologous blood injection procedure
16047106|NCT02546089|Other|Structured rehabilitation programme|(this intervention is given to patients in both arms of the study) - a standardised structured rehabilitation programme of home exercises that the patient is instructed on how to start, and how to progress during the study period
16047107|NCT02546089|Other|dry needling injection|(this intervention is given to patients in both arms of the study) - ultrasound-guided dry needling injection performed under ultrasound guidance
16047108|NCT02546076|Device|Laser coagulation|The treatment consists in performing Er:Yag laser with long-pulsed Erbium mode
16047109|NCT02546076|Device|Laser w/o coagulation|The treatment consists in performing Er:Yag laser with true pulsed Erbium mode
16047149|NCT02545777|Drug|diclofenac sodium enteric-coated|
16047272|NCT02544893|Drug|serum physiologic|21 ml serum physiologic is applied paravertebral space
16047110|NCT02546063|Other|Smartphone App|The GoCARB system is a smartphone application designed to support type 1 diabetic patients with carbohydrate counting by providing automatic, accurate and near real-time CHO estimation for non-packed foods.
16047111|NCT02546050|Drug|Metformin|
16047112|NCT02546037|Device|FX100 dialyzer|comparison of dialyzers
16047113|NCT02546037|Device|SOLACEA 21H|comparison of dialyzers
16047114|NCT02546024|Drug|Standard care|Standard care according to Care Pathway for depression by Mental Health of Older Adults Services Clinical Academic Group of the South London and Maudsley NHS Foundation Mental Health Trust
16047115|NCT02546011|Other|Fetal Heart Rate Monitor|Standard of care, not part of research
16047116|NCT02545998|Other|Telehealthcare|Telephone consultation plus e-mail with attached PAAP and video link
16047117|NCT02545985|Device|Prolim stent deployment|Prolim stent was implanted in patients who signed the informed consent and met the exclusion and inclusion criteria.
16047118|NCT02545972|Drug|tacrolimus extended release|daily dosing of tacrolimus
16047119|NCT02545959|Drug|Rituximab IT|CSF injection of intrathecal rituximab (20mg)
16047120|NCT02545959|Drug|methylprednisolone IV|blood infusion of methylprednisolone IV (120mg)
16047121|NCT02545959|Drug|Rituximab IV|Blood infusion of rituximab (375mg/m2)
16047122|NCT02545946|Device|vessel loop|using the vessel loop to hold the place of the surgical wound that is made during I&D
16047123|NCT02545946|Other|traditional I&D with or without packing|abscess will be drained with a traditional I&D with or without packing (as deemed appropriate by ER doctor)
16047124|NCT02545933|Drug|Prasugrel|Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
16047125|NCT02545933|Drug|Vorapaxar|Vorapaxar will be administered at the dose of 2.5mg once daily
16047126|NCT02545933|Drug|Aspirin|Aspirin will be administered at the dose of 81mg once daily
16047127|NCT02545933|Drug|Ticagrelor|Patients will continue treatment with either prasugrel (10mg once daily) or ticagrelor (90mg twice/daily)
16047128|NCT02545920|Other|no intervention|observational study
16047129|NCT02545907|Drug|Carfilzomib|Lyophilized carfilzomib for injection reconstituted with water to a final concentration of 2 mg/mL.
16047130|NCT02545907|Drug|Thalidomide|50mg capsule.
16047131|NCT02545907|Drug|Dexamethasone|2mg tablet.
16047132|NCT02545894|Behavioral|Cognitive therapy|"The tasks are:
~visually tracking a picture as it moves across the computer screen
~pressing a button every time a picture is seen on the screen
~pressing a button every time a specific picture is seen on the screen
~Pressing a button every time a specific sound is heard
~Matching objects to a picture
~Matching gestures to objects
~Matching two connected objects
~Sorting objects by categories
~Matching sounds to objects
~Complete the category and odd on out with objects
~Choosing target objects by pointing
~Choosing objects to complete the category by pointing"
16047133|NCT02545881|Other|Magnetic Resonance Imaging (MRI)|MRI of the prostate prior to prostatectomy
16047134|NCT02545868|Biological|23-PPV|The 23-PPV vaccine will be given as a 0.5-milliliter (mL) intramuscular (IM) injection in the deltoid muscle on Day 112 (Group A) or Day 28 (Group B).
16047135|NCT02545868|Biological|13-PCV Booster|The 13-PCV booster will be given as an IM injection in the deltoid muscle on Day 140 (select participants in Group A).
16047136|NCT02545868|Biological|Influenza Vaccine|The influenza vaccine will be given as an IM injection in the deltoid muscle at any time between Day 85 and Day 144 (select participants in Group A) or any time between Day 1 and Day 85 (Group B).
16047137|NCT02545868|Biological|KLH|KLH will be given as a 1-mg subcutaneous (SC) injection on Days 84, 112, and 140 (Group A) or Days 1, 28, and 56 (Group B).
16047138|NCT02545868|Drug|OCR|OCR will be given as an intravenous (IV) infusion at a dose of 600 mg, with the first dose given as two infusions of 300mg 14 days apart, according to the specifications described in the corresponding Group A and Group B arms.
16047139|NCT02545868|Biological|TT Vaccine|The TT-containing adsorbed vaccine will be given as a 0.5-mL IM injection in the deltoid muscle on Day 85 (Group A) or Day 1 (Group B).
16047140|NCT02545855|Device|High-flow nasal cannula therapy|All subjects will receive nocturnal high-flow nasal cannula therapy with the myAIRVO2®, in addition to their current HOT. The myAIRVO2® is used for at least 4 hours per day with flow rates in the range 30-40 L/min. The investigator can adjust the nocturnal oxygen flow rates to keep SpO2 88-92% stably. If the subjects report discomfort, the investigator can adjust the flow rates in the range at least 20 L/min.
16047141|NCT02545855|Device|Home oxygen therapy (HOT)|All subjects will continue their current HOT which kept original usage conditions at the time of enrollment throughout the entire duration of the study regardless of treatment arm assignment.
16047142|NCT02545842|Drug|INSULIN GLARGINE|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
16047143|NCT02545829|Drug|HIP1302|Tenofovir 292mg
16047144|NCT02545829|Drug|HGP1406|Tenofovir 300mg
16047145|NCT02545816|Device|Bispectral index (BIS) EEG monitoring|The Bispectral Index (BIS) EEG monitor is a simplified EEG monitoring device which was originally designed to monitor the depth of hypnosis during general anesthesia. It does this by analyzing changes in the processed electroencephalogram (EEG) which occur with the hypnotic state and creating a measure (or index) indicative of these changes. A number between 0 and 100 is derived, with values above 70 associated with an awake state. The monitor also provides a single channel EEG, an electromyogram (EMG) and an index of signal quality (SQI), all in real time.
16047146|NCT02545803|Device|Near-Infrared Spectroscopy (NIRS)|Near infrared spectroscopy (NIRS) is a non-invasive technique that uses near infrared light between 700 and 1100nm which penetrates several centimeters through skin and bone structures. Light is absorbed by chromophores. There are multiple chromophores which can be detected in the NIR spectrum such as water, lipids, melanin, myoglobin, oxygenated hemoglobin and deoxygenated hemoglobin. Each chromophore has a specific absorption spectrum. By using different wavelengths, it is possible to differentiate chromophores. The difference between oxygenated hemoglobin and deoxygenated hemoglobin can be calculated using the modified Beer-Lambert law, resulting in a numeric value which is a representation of the regional cerebral oxygen saturation
16047147|NCT02545790|Procedure|Echocardiogram|2 and 3-dimensional echocardiographic images will be obtained to estimate LV mass, ejection fraction (Simpson's biplane), fractional shortening (M mode Doppler), and pulse-wave estimated pressure gradient across the outflow obstruction.
16047150|NCT02545777|Drug|Oral medicine of tonifying spleen and descending turbid|Ingredient:cortex phellodendrine, rhizoma atractylodis, radix cyathula, coix seed, cotton Bi Xie,rhizoma smilacis glabrae
16047151|NCT02545777|Drug|Steeping and washing medicine of descending turbid and clearing heat|Ingredient: turmeric, rhubarb, cortex phellodendrine, rhizoma atractylodis, rhizoma arisaema, angelica dahurica,garden balsam stem, pseudobulbus cremastrae seu pleiones
16047152|NCT02545777|Drug|Wet wrapping medicine of descending turbid and clearing heat|Ingredient:turmeric, rhubarb, cortex phellodendrine, rhizoma atractylodis, rhizoma arisaema, angelica dahurica, pseudobulbus cremastrae seu pleiones.
16047153|NCT02545764|Other|Strength and neuromuscular exercise programme|12 weeks strength and neuromuscular exercise programme for the lower extremity
16047154|NCT02545751|Radiation|Stereotactic Body Radiation Therapy|SBRT is given during combined therapy to one of the metastatic lesions, 25Gy in 5 fractions (5Gy per fraction) over one week, conformally to maximally spare normal tissue or organ.
16047155|NCT02545751|Drug|Thymalfasin|Thymalfasin treatment is given twice a week with an interval of 3-4 days until progression of other metastatic lesions. Tumor response is evaluated by assessing clinical and CT/MRI response for all the other measurable metastatic sites.
16047156|NCT02545738|Drug|Liraglutide|active treatment
16047157|NCT02545738|Drug|placebo|placebo
16047158|NCT02545725|Other|Questionnaire on Quality of Life|The patients were asked to complete a questionnaire on Quality of Life
16047159|NCT02545712|Other|Exposure to ethanol|The drug source(s) and amount administered daily are noted.
16047160|NCT02545712|Other|Exposure to propylene glycol|The drug source(s) and amount administered daily are noted.
16047161|NCT02545712|Other|Exposure to benzyl alcohol|The drug source(s) and amount administered daily are noted.
16047162|NCT02545712|Other|Exposure to acesulfam potassium|The drug source(s) and amount administered daily are noted.
16047163|NCT02545712|Other|Exposure to aspartame|The drug source(s) and amount administered daily are noted.
16047164|NCT02545712|Other|Exposure to glycerol|The drug source(s) and amount administered daily are noted.
16047165|NCT02545712|Other|Exposure to sorbitol|The drug source(s) and amount administered daily are noted.
16047166|NCT02545712|Other|Exposure to methyl-p-hydroxybenzoate|The drug source(s) and amount administered daily are noted.
16047167|NCT02545712|Other|Exposure to propanyl-p-hydroxybenzoate|The drug source(s) and amount administered daily are noted.
16047168|NCT02545712|Other|Exposure to polysorbate-80|The drug source(s) and amount administered daily are noted.
16047169|NCT02545699|Device|G-EYE™ Colonoscopy|G-EYE™ Colonoscopy
16047170|NCT02545699|Device|Standard Colonoscopy|Standard Colonoscopy
16047171|NCT02545686|Behavioral|Chest wall movement assessment without CPAP|While subject is breathing normally, determine chest wall movement (via RPM waveform) with free breathing, over the course of half an hour.
16047172|NCT02545686|Behavioral|Breath hold assessment without CPAP|While subject is breathing normally, subject will perform a moderate and a deep inspiratory breath hold. Duration, reproducibility and tolerance of deep inspiratory breath hold will be recorded.
16047173|NCT02545686|Procedure|Chest wall movement assessment with CPAP|While subject is breathing via CPAP machine, determine chest wall movement (via RPM waveform) with free breathing, over the course of half an hour.
16047174|NCT02545686|Procedure|Breath hold assessment with CPAP|While subject is breathing via CPAP machine, subject will perform a moderate and a deep inspiratory breath hold. Duration, reproducibility and tolerance of deep inspiratory breath hold will be recorded.
16047175|NCT02545673|Behavioral|Enhanced linkage to care|
16047176|NCT02545673|Behavioral|Standard-of-care plus|
16047177|NCT02545660|Other|QLF Image|At each of the three visits tooth brushing advice will be given. The participants in the intervention group will be shown the QLFD images or white light images.Standardized oral hygiene reinforcement shall be given based on the images. The oral hygiene instruction will focus on the areas of the teeth which require greater emphasis, as shown by the images. Thus the patients should benefit from this detailed instruction.
16047178|NCT02545660|Other|White Light Image|At each of the three visits tooth brushing advice will be given. The participants in the white light image group will be shown white light images.Standardized oral hygiene reinforcement shall be given based on the images. The oral hygiene instruction will focus on the areas of the teeth which require greater emphasis, as shown by the images. Thus the patients should benefit from this detailed instruction.
16047179|NCT02545647|Device|BRYGB|65 patients undergo a banded RYGB
16047180|NCT02545634|Dietary Supplement|L. helveticus R0052 and B. longum R0175|See arm descriptions for intervention description.
16047181|NCT02545634|Other|Placebo|
16047182|NCT02545621|Other|RAGE TXNIP Inflammasome axis|
16047183|NCT02545608|Device|Restylane Vital|
16047184|NCT02545595|Drug|Sugammadex 1 mg/kg|
16047185|NCT02545595|Drug|Sugammadex 2 mg/kg|
16047186|NCT02545595|Drug|Sugammadex 4 mg/kg|
16047187|NCT02545582|Device|VITARIA System|Implantable vagus nerve stimulator
16047188|NCT02545569|Device|hearing aid (MD class IIa) - ITE, BTE, RIC|Hearing aid means any wearable instrument or device designed for, offered for the purpose of, or represented as aiding persons with or compensating for, impaired hearing.
16047189|NCT02545556|Procedure|HepaSphere combined with cryosurgery|liver cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）combined with cryosurgery
16047190|NCT02545543|Biological|Seqirus QIV|"Seqirus QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
~The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
16047191|NCT02545543|Biological|Comparator QIV|"The US-licensed Comparator QIV, inactivated, split-virion, thimerosal-free, quadrivalent influenza vaccine, administered as a 0.5 mL intramuscular dose. The vaccine is presented in a prefilled needleless syringe.
~The subject's age and influenza vaccination history determines the dosing regimen (a single vaccination or a 2-vaccination regimen administered 28 days apart) according to the most recent US ACIP guidelines for seasonal influenza vaccination."
16047192|NCT02545530|Drug|transdermal clonidine|2.5mg/patch per week
16047193|NCT02545517|Biological|Rabipur|Subjects in all the groups received Rabipur vaccine booster dose, administered intramuscularly in the deltoid region of the non-dominant arm
16047194|NCT02545517|Procedure|Blood sampling|Blood samples were drawn from all subjects at day 1 and then at subsequent year intervals from extension study day 1 onwards.
16047195|NCT02545504|Drug|Andecaliximab|800 mg administered intravenously on Days 1 and 15 of each 28-day treatment cycle
16047196|NCT02545504|Drug|Placebo|Administered intravenously on Days 1 and 15 of each treatment cycle
16047197|NCT02545504|Drug|Leucovorin|Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
16047198|NCT02545504|Drug|5-fluorouracil|Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
16047199|NCT02545504|Drug|Oxaliplatin|Administered intravenously per standard of care on Days 1 and 15 of each treatment cycle
16047200|NCT02545491|Behavioral|Care for Child Development (CCD) program|The Care for Child Development (CCD) Program developed by World Health Organization (WHO) /UNICEF provides recommendations for stimulating child development through play and communication activities.
16047201|NCT02545491|Behavioral|Infant and Young Child feeding training by World Vision|Training on breastfeeding benefits, solid introduction and food safety
16047202|NCT02545465|Drug|Riociguat (Adempas, BAY63-2521)|As per the treating physicians discretion
16047203|NCT02545452|Drug|Anastrozole / Levonorgestrel (BAY98-7196)|Release rate of the IVR: 1050 μg/d ATZ + 40 μg/d LNG
16047204|NCT02545452|Drug|Gyno-Daktarin|400 mg miconazole nitrate per day for 3 consecutive days
16047205|NCT02545452|Drug|Sobelin vaginal creme|100 mg clindamycin 2-dihydrogen phosphat per day for 3 consecutive days
16047206|NCT02545452|Drug|Patentex oval|75 mg Nonoxynol-9 per day for 3 consecutive days
16047207|NCT02545452|Other|Tampon|
16047208|NCT02545439|Drug|ALKS 5461|Sublingual tablet given alone and in conjunction with Rifampin
16047209|NCT02545426|Other|Change the dialysate calcium concentration|The dialysate calcium concentration will be changed according to the prior concentration
16047210|NCT02545413|Drug|Probiotic VSL#3|
16047211|NCT02545413|Drug|Placebo|
16047212|NCT02545374|Other|Telemedicine|
16047213|NCT02545374|Other|Control|
16047214|NCT02545361|Drug|KAHR-102|"KAHR-102 is a dual signaling protein (DSP).KAHR-102 will be administrated subcutaneously. In Stage 1A, 3 KAHR-102 SC injections will continue to be given every 14 days with an interval of 28 days after 1st cycle and 14 days after 2nd cycle and following cycles.
~In Stage 1B and Stage 2, subjects will be administered 3 KAHR-102 SC injections given every 7 days with an interval of 28 days after 1st cycle and 14 days after 2nd cycle and following cycles.
~Planned doses for stage 1:
~Cohort A: 2µg/kg Cohort B: 4 µg/kg Cohort C: 8 µg/kg Cohort D: 12 µg/kg Each cohort will only begin its first administration of KAHR-102 SC injection when the cohort preceding it will not meet criteria for a DLT (at least 7 days)."
16047215|NCT02545348|Procedure|Sentinel Lymph Node Biopsy|First, the detection of the sentinel node will be preformed at the beginning of the surgery. Differents detection methods are use and the efficacy of each will be recorded. Second, dissection and extraction of the sentinel node will be performed, to send it to the frozen section examination. Third, other lymph node could be removed if the surgeon evaluate that it is feasible and necessary. In this group, the false negative rate will be also evaluate.
16047216|NCT02545322|Radiation|Follow-up CT scans during week 3 and week 5 of treatment|Scheduled follow-up planning CT scan and re-optimisation of the intensity modulation radiation therapy (IMRT)-based radiotherapy Treatment plan. Dosimetric Evaluation and assessment of morphologic changes.
16047217|NCT02545296|Other|In-vitro Diagnostics|Ex-vivo performed diagnostic blood based test.
16047218|NCT02545283|Drug|Cytarabine|Participants will receive cytarabine 1 gram per square meter (g/m^2) intravenous (IV) infusion for 5 days of every treatment cycle.
16047219|NCT02545283|Drug|Idasanutlin|Participants will receive idasanutlin 300 mg per oral (PO) twice daily (BID) (in Cycle 1) or once daily (QD) (in Cycles 2 and 3) for 5 days of every treatment cycle.
16047220|NCT02545283|Other|Placebo|Participants will receive idasanutlin matching placebo PO BID or QD for 5 days of every treatment cycle.
16047221|NCT02545270|Procedure|Level of pneumoperitoneum 12-9-6 mmHg|Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (12-9-6 mmHg) during desufflation.
16047222|NCT02545270|Procedure|Level of pneumoperitoneum 11-8-5 mmHg|Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (11-8-5 mmHg) during desufflation.
16047223|NCT02545270|Procedure|Level of pneumoperitoneum 10-7-4 mmHg|Elective laparoscopic inguinal hernia procedures will be used to make video-recordings under 3 different levels of pneumoperitoneum (10-7-4 mmHg) during desufflation.
16047224|NCT02545257|Other|Coordinated medication management model|Stage I: a prescription review conducted by community pharmacists Stage II: practical nurse-administered Drug-related Problem Risk Assessment Tool Stage III: Required health care action based on the result of the DRP -Risk Assessment Tool
16047225|NCT02545244|Dietary Supplement|Black Tea|0.5% Black Tea 5mL used as Mouthwash twice daily for two weeks after scaling of teeth.
16047226|NCT02545244|Dietary Supplement|Green Tea|0.5% Green Tea 5mL used as Mouthwash twice daily for two weeks after scaling of teeth.
16047227|NCT02545244|Drug|0.12% Chlorhexidine Mouthwash.|5mL of 0.12% Chlorhexidine used as mouthwash twice daily for two weeks after scaling of teeth.
16047228|NCT02545231|Drug|Pitavastatin 1mg|To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia
16047229|NCT02545231|Drug|Pitavastatin 4mg|To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia
16047230|NCT02545231|Drug|Placebo|To compare different doses of statins on atherosclerosis progression and neointimal hyperplasia
16047231|NCT02545218|Procedure|Perineorraphy|Surgery for improperly healed perineal tear
16047232|NCT02545218|Other|Pelvic floor exercise|Pelvic floor exercise tutored by physio therapist.
16047233|NCT02545205|Device|Hybrid Assistive Limb (HAL)|Intensive gait training with Hybrid Assistive Limb (HAL) is performed, 1 session/day, 4 days/week during 4 weeks. Time for each session is individualised but does not exceed 60 minutes/session (effective walking time with HAL).
16047269|NCT02544906|Drug|dexmedetomedine|Infusion of dexmedetomedine to prevent emergence agitation in liver transplanta recipients
16047234|NCT02545205|Other|Conventional gait training|The conventional gait training is performed according to current best evidence based practice and may include over ground walking with assistance and/or assistant devices as well as the use of a treadmill and body weight support and training of gait function in activities of daily living.
16047235|NCT02545192|Device|Low Field Magnetic Stimulation|The LFMS Device is an electromagnetic coil situated on a cylinder with an inside diameter of 13.2 inches. It produces weak electromagnetic fields at a frequency of about 1000Hz; the magnetic fields are less than 30 Gauss and the electric fields are up to 1.43 V/m. A fully detailed description of the electromagnetic field distribution and waveform has been presented in the IDE submission to the FDA (and determined to be a non-significant risk device).
16047236|NCT02545179|Other|web-based daily care training|12 week interactive web based caring training education
16047237|NCT02545153|Drug|Tisseel, Baxter (Aprotinin and Fibrinogen)|After introducton of t tube and closure of the incision with running sutures, fibrin sealant is applied on the incision.
16047238|NCT02545153|Drug|Control|No fibrin sealant applied
16047239|NCT02545140|Other|No intervention|
16047242|NCT02545114|Drug|Tolvaptan|Use of Tolvaptan to treat SIADH-induced hyponatremia in selected patients with acute neurological injuries.
16047243|NCT02545088|Device|Hybrid Assistive Limb (HAL)|Intensive gait training with Hybrid Assistive Limb (HAL) is performed 1 session/day, 3 days/week for 6 weeks and each session will not exceed 60 min of effective walking time with HAL. In addition, each session will include conventional gait training that will not exceed 30 min effective training time.
16047244|NCT02545088|Other|1st control group|Conventional gait training performed 1 session/day, 3 days/week for 6 weeks that will not exceed 1h 30 min effective training time.
16047245|NCT02545088|Other|2nd control group|The 2nd control group will not receive an intervention.
16047246|NCT02545075|Drug|Ipilimumab|
16047247|NCT02545075|Drug|Dacarbazine|
16047248|NCT02545062|Other|MoCa test|The MoCa test is actually used for the screening of Mild Cognitive Impairment . It is a one page 30 points test that can be done in 10 minutes in a routine annual visit to the Diabetes Clinic. The MoCa assesses several cognitive domains, and it is available in hebrew language.
16047249|NCT02545049|Drug|Finerenone (BAY94-8862)|10 mg or 20 mg Finerenone tablet to be given orally, once daily.
16047250|NCT02545049|Drug|Placebo|Matching placebo to be taken orally, once daily.
16047251|NCT02545036|Other|Traditional Chinese Medicine (TCM) daycare model|Traditional Chinese Medical (TCM) daycare model provides multiple approaches of traditional Chinese medical treatment, including 5 tones of Chinese music, massage for meridians and collaterals, acupuncture, and patient education. The treatment course is one time a week, for 12 weeks (12 treatments in total).
16047252|NCT02545023|Other|Quality-of-Life Assessment|Complete an in-person one-on-one interview
16047253|NCT02545023|Other|Questionnaire Administration|Complete the demographics questionnaire, SCNS-34, SF-36, and Lifestyle Needs Survey
16047254|NCT02545010|Drug|Paclitaxel|"All patients will receive weekly paclitaxel at a pre specified dose of 80 mg/m2, 70 mg/m2, 60mg/m2 or 50 mg/m2 via intravenous infusion according to institution specific standard practices.
~Cycles of chemotherapy will be administered weekly without interruption on Days 1,8,15,22,29,36 for a total of 6 weekly cycles in combination with LDWART. Post treatment assessments will be conducted starting Day 43.
~Patients will then continue chemotherapy off trial protocol with weekly paclitaxel without concurrent LDWART starting Day 50 till disease progression, intolerable toxicity, patient refusal or deemed inappropriate to continue treatment by treating physician."
16047255|NCT02545010|Radiation|LDWART (Low Dose Whole Abdominal Radiation Therapy)|"LDWART will be given at 60 cGy fractions, twice daily for two days, with a minimum of 4 hours inter fraction interval, starting on day 1 of each cycle of weekly paclitaxel for 6 weeks.
~LDWART will not be administered if doses of weekly paclitaxel are withheld for any reason since it functions as a chemosensitizer. LDWART will be administered together weekly paclitaxel immediately at point of recovery from toxicity and patient is deemed to be able to continue with treatment by investigator."
16047256|NCT02544997|Drug|Poziotinib|12mg P.O. for 2wks q21days
16047257|NCT02544984|Drug|Azithromycin|Patients will receive azithromycin at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.
16047258|NCT02544984|Drug|placebo|Patients will receive placebo at a dose of 5 mg/kg to be given once a day on Monday, Wednesday, and Friday. The dosage will not be adjusted if a new weight is obtained during the trial period.
16047259|NCT02544971|Behavioral|Neurofeedback|Neurofeedback is based on the learned change in a particular neural signal or a combination of neural signals when feedback and reward of these signals are repeatedly presented to the organism. Thus, individuals learn to modulate their neural activity through a closed NF loop.
16047260|NCT02544971|Other|Control|Treatment as usual
16047261|NCT02544958|Device|Er:YAG laser|Er:YAG laser treats enlarged pores on both sides of the face for 4 treatments of 1 month interval.
16047262|NCT02544945|Other|3D printed bolus|Using the Cat Scan for treatment planning, a 3D plastic shell can be produced which is shaped exactly to the shape of the patient's chest wall. This shell will act as bolus - the substance that is placed on the skin during chest wall radiotherapy. The bolus allows the right dose of radiotherapy to get to the skin and the underlying chest wall.
16047263|NCT02544945|Other|Standard bolus|A standard 5mm-thick piece of rubber is placed on the patient's chest wall
16047264|NCT02544932|Drug|dabigatran|After randomization, patients of this group was will be treated to dabigatran 110mg or 150mg twice a day for 24months
16047265|NCT02544932|Drug|ribaroxaban|After randomization, patients of this group was will be treated to ribaroxaban 20mg once a day for 24months.
16047266|NCT02544932|Drug|Warfarin|After randomization, patients of this group was will be treated to warfarin and controlled by INR 2-3 for 24months.
16047267|NCT02544919|Drug|SMOF lipid (SMOFLIPID) pre treatment|Experimental Arm
16047268|NCT02544906|Drug|Propofol|Infusion of propofol to prevent emergence agitation in liver transplanta recipients
16047270|NCT02544893|Drug|bupivacaine|21 ml 0.5 %bupivacaine is applied paravertebral space
16047273|NCT02544880|Drug|Tadalafil|Tadalafil tablets administered by mouth. Dose will be between 10 to 20 mg adjusted depending on patient's body weight. On course 1, Tadalafil will be administered daily for 19 consecutive days. On Course 2 through 4, Tadalafil will be administered daily for 14 consecutive days. No Tadalafil will be provided on Course 5.
16047274|NCT02544880|Biological|Anti-MUC1 Vaccine|300 uL Anti-MUC1 vaccine will be administered intramuscularly in the right upper limb. Anti-MUC1 vaccine will be administer on Day 7 on course 1, on Day 10 for courses 2 through 4 and on Day 1 on course 5.
16047275|NCT02544880|Biological|Anti-Influenza Vaccine|300 uL Anti-Influenza vaccine will be administered intramuscularly in the left upper limb. Anti-Influenza vaccine will be administer on Day 7 on course 1, on Day 10 for courses 2 through 4 and on Day 1 on course 5.
16047276|NCT02544880|Other|Tadalafil Placebo|Placebo tablets mimicking Tadalafil administered by mouth. On course 1, Tadalafil Placebo will be administered daily for 19 consecutive days. On Course 2 through 4, Tadalafil placebo will be administered daily for 14 consecutive days. No Tadalafil Placebo will be provided on Course 5.
16047277|NCT02544880|Other|Anti-MUC1 Vaccine Placebo|Placebo for Anti-MUC1 vaccine will be administered intramuscularly in the right upper limb. Placebo for Anti-MUC1 vaccine will be administer on Day 7 on course 1, on Day 10 for courses 2 through 4 and on Day 1 on course 5..
16047278|NCT02544880|Other|Standard of Care Treatment|Treatment according to prescribed standard of care regimen.
16047279|NCT02544880|Other|Anti-Influenza Vaccine Placebo|Placebo for Anti-Influenza vaccine will be administered intramuscularly in the left upper limb. Placebo for Anti-Influenza vaccine will be administer on Day 7 on course 1, on Day 10 for courses 2 through 4 and on Day 1 on course 5.
16047280|NCT02544867|Behavioral|Sedentary behavior|Participants were randomized to either reduce their total sitting time or increase sit-to-stand transitions. Information was provided in person, through written materials and by emails and phone calls in both conditions. Both groups received written educational materials on the dangers of excessive sitting and reviewed a generic day to illustrate how many sitting opportunities individuals face each day. During each session, the health educator also discussed the benefits of sitting less or increasing sit-to-stand transitions (depending on study condition) and brainstormed potential barriers to implementing the new behavior as well as strategies to overcome these barriers.
16047281|NCT02544854|Drug|Propofol|"Propofol infusion will be started after inhalational induction by manual infusion by the following scheme:
~First 15 minutes: 15 mg/kg/min
~16 to 30 minutes: 13 mg/kg/min
~31 to 60 minutes: 11 mg/kg/min
~61 to 120 minutes: 10 mg/kg/min Dose will be titrated to maintain BIS between 40 - 50.
~Venous sampling for plasmatic levels of propofol measuring will be made at the following moments:
~5, 15 and 25 minutes of starting infusion,
~1, 3, 5, 7, 9 and 12 minutes of bolus and,
~5, 25, 60 and 120 minutes of infusion ended."
16047282|NCT02544841|Behavioral|Safer Sex Intervention (SSI)|Safer Sex Intervention (SSI) is an in-person, individual-level, clinic-based intervention implemented by a female health educator trained in the intervention. It is intended to be implemented in one initial session lasting 30-50 minutes and three booster sessions lasting 10-30 minutes at one, three, and six month intervals.
16047283|NCT02544841|Behavioral|Female Sexual Health|Female Sexual Health is a knowledge-based intervention that intends to provide information on how STIs are contracted, the consequences of contracting STIs, and how to prevent them. Female Sexual Health includes the information-only component of the first session of SSI and baseline exposure to a health educator but does not include booster sessions.
16047284|NCT02544828|Drug|Iron Sucrose 200mg|Iron Sucrose 200mg is administered after anesthesia induction.
16047285|NCT02544828|Drug|placebo|placebo (normal saline) is administered after anesthesia induction
16047286|NCT02544815|Drug|Digoxin|Digoxin 0.25 mg pills
16047287|NCT02544815|Drug|Placebo|Placebo pills
16047288|NCT02544802|Drug|Adipose-Derived Mesenchymal Stem Cells|
16047289|NCT02544789|Drug|Clofarabine|Clofarabine (Betta Pharmaceuticals Co., Ltd, Zhejiang, China) was administered intravenously at 52 mg/m2 over 2 hours daily for 5 consecutive days. During the first two induction cycles, patients who did not achieve an objective response were taken off the study, and responsive patients continued to receive consolidation for a maximum 11 cycles if non-hematological toxicity was grade 2 or less.
16047290|NCT02544776|Drug|Clomifene citrate ( clomid 50 mg )|
16047291|NCT02544776|Drug|Amlodipine|
16047292|NCT02544763|Drug|GWP42003-P|Yellow oily solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
16047293|NCT02544763|Drug|Placebo|Yellow oily solution containing the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
16047294|NCT02544750|Drug|GWP42003-P|Yellow oily solution containing cannabidiol dissolved in the excipients sesame oil and anhydrous ethanol with added sweetener (sucralose) and strawberry flavoring.
16047295|NCT02544737|Drug|Apatinib|Patients with metastatic lesions of esophageal cancer after been treated with surgery or definitive chemoradiotherapy receiving Apatinib (850mg) daily over 4 weeks.
16047296|NCT02544724|Biological|NM-IL-12|Single SC administration of NM-IL-12 will be administered at least 48 hours after completion of the last chemotherapy dose of each cycle
16047297|NCT02544711|Device|Patient specific instrument|The proposed innovation consists in using patient specific instrument (PSI) for tumor resection. It is compounded of a preoperative assistance to plan the surgery and an intraoperative assistance to reproduce the preoperative planning.
16047298|NCT02544711|Procedure|Conventional surgical treatment|The conventional treatment is planned on two-dimensional images (CT and MRI).
16047299|NCT02544698|Biological|One dose of PCV13a vaccine|
16047300|NCT02544698|Biological|One dose of PCV13a vaccine|
16047301|NCT02544698|Biological|three doses of PCV13a vaccine|
16047302|NCT02544698|Biological|three doses of PCV13a vaccine|
16047303|NCT02544685|Dietary Supplement|Probio-Fix Inum|"Dose of Probio-Fix Inum: 1 capsule daily first 14 days + 1 capsule twice daily for the rest of prophylaxis duration
~Probio-Fix Inum: each capsule contains 2.7 billion lyophilized probiotic bacteria Lactobacillus rhamnosus GG, LGG, American Type Culture Collection (ATCC) 53103 and Bifidobacterium animalis subspecies. lactis BB-12 Chr. Hansen Beneo Synergy 1: oligofructose-enriched inulin"
16047304|NCT02544685|Dietary Supplement|Beneo Synergy 1|Dose of Beneo Synergy 1: depends on the age of the patient (full dose variation: 0,2g/100ml milk formula - 12g/daily), gradually increased as tolerated by the patient every 2-3 days in first 8-12 days
16047305|NCT02544685|Other|Placebo|Same dosage regimen as active drugs
16047306|NCT02544672|Device|Myoelectric Elbow-Wrist-Hand orthosis|An arm orthosis that uses myoelectric signals to control the level of mechanical assistance provided to a user's elbow and hand in order to overcome upper limb weakness or paralysis and achieve functional tasks.
16047307|NCT02544659|Drug|pamidronate disodium|the patients will be administered pamidronate disodium 1 mg/kg, IV, QD, for 3 days, and every 3 month (up to month 6)
16047308|NCT02544646|Other|Changes in Ocular rigidity|measured before the operation and 28±7 days after the operation
16047309|NCT02544633|Drug|MGCD265|MGCD265 is a small molecule multi-targeted receptor tyrosine kinase inhibitor
16047310|NCT02544620|Other|Does fulfil of discharge criteria on the day of the surgery|
16047311|NCT02544620|Other|Does not fulfil of discharge criteria on the day of the surgery|
16047312|NCT02544607|Drug|Ketamine|Ketamine 0.5mg/kg over 40 minutes IV
16047313|NCT02544607|Other|Magnetic Resonance Imaging (MRI)|MRI technology will be used before and after ketamine for patients with depression
16047314|NCT02544594|Device|Extra-Corporal Life Support (ECLS)|Extra-Corporal Life Support (ECLS) (from Sorin)
16047315|NCT02544581|Other|Soberlink combined with aftercare services|Soberlink Alcohol Breath Analyzer System combined with aftercare services
16047316|NCT02544568|Other|Meals|At 4 different occasions the participants will receive meals with the same amount of calories and different composition of fat, protein, carbohydrate and fiber.The composition of the meals is: Low-fat / high-carbohydrate meal (18 E% proteins, 28 E% fat and 54% carbohydrates), high-fat meal (18 E% protein, 50 E% fat and 31 E% carbohydrate), high-protein meal (40 E% protein, 30 E% fat and 30 E% carbohydrates) and low-fat / high-carbohydrate and high fiber (18 E% proteins, 28 E% fat and 54 E% carbohydrates and 15 gram of fibers).
16047317|NCT02544555|Procedure|Intentional intraluminal approach|Interventionist performs intentional intraluminal approach to angioplasty. Dedicated 018 and 014 guidewire for Chronic Total Occlusion (CTO) lesion and Chronic Total Occlusion (CTO) devices such as Truepath or Frontrunner can be chosen by interventionist. Methods to confirm successful intraluminal wiring will be selected, as follows; 1) examination for guidewire position in different two angles on fluoroscopy or 2) intravascular ultrasound (IVUS) exam after predilation is performed with an appropriately sized angioplasty balloon. After the guidewire is passed through the lumen of target lesion, predilation of the target lesion with an optimally sized balloon will be performed prior to stent implantation. Provisional stenting should be performed, if the case that optimal ballooning response is not obtained.
16047318|NCT02544555|Procedure|Intentional subintimal approach|Interventionist performs Intentional subintimal approach to angioplasty. 035 Terumo guidewires will be used. If 035 Terumo guidewire is not able to re-entry, Re-entry devices such as Offroad or OUTBACK catheter can be used. After the guidewire is passed through the subintimal layer of target lesion, predilation of the target lesion with an optimally sized balloon will be performed prior to stent implantation. Provisional stenting should be performed; the case that optimal ballooning response is not obtained should be enrolled. The sub-optimal balloon response is defined as a residual pressure gradient of >15 mmHg, residual stenosis of >30%, and flow-limiting dissection.
16047319|NCT02544542|Device|Rectum cooling system|
16047320|NCT02544542|Device|Hyper-hypothermia blanket|
16047321|NCT02544529|Drug|Echothiophate Iodide 0.03% Ophthalmic Solution|one drop to each eye three times per week for 18 weeks
16047322|NCT02544529|Drug|Carboxymethylcellulose Sodium (0.5%)|one drop to each eye three times per week for 18 weeks
16047323|NCT02544516|Other|cognitive tasks + PANSS+ IQ|Patients will have cognitive tasks: reaction time (Alert TEA, Zimmermann and Fimm, 2005), Edinburgh laterality questionnaire (Oldfield, 1971), IQ test (IQ: PM38, Raven, 1960), and the PANSS (Positive and Negative Syndrome Scale, Kay et al., 1987
16047324|NCT02544516|Other|cognitive tasks|Patients will have cognitive tasks: reaction time (Alert TEA, Zimmermann and Fimm, 2005), Edinburgh laterality questionnaire (Oldfield, 1971),
16047325|NCT02544503|Device|Single-pulse Transcranial Magnetic Stimulation (TMS)|Single-pulse Transcranial Magnetic Stimulation (TMS) is a brief magnetic pulse that is applied through an air-cooled coil to the section of the head that overlays the motor cortex of the brain. Subjects will be comfortably seated in a dental chair surrounded by a frame that carries a coil holder to assist with the application of TMS to the brain. Single-pulse transcranial magnetic stimulation (TMS) will be administered at 1 month visit and 6 month visit.
16047326|NCT02544503|Device|Paired-pulse Transcranial Magnetic Stimulation (ppTMS)|Paired-pulse Transcranial Magnetic Stimulation (ppTMS) is two brief sequential magnetic pulses that are applied through an air-cooled coil to the section of the head that overlays the motor cortex of the brain.Subjects will be comfortably seated in a dental chair surrounded by a frame that carries a coil holder to assist with the application of TMS to the brain. Paired-pulse transcranial magnetic stimulation (ppTMS) will be administered at 1 month and 6 month visit.
16047327|NCT02544503|Device|Low-frequency Repetitive Transcranial Magnetic Stimulation (rTMS)|Low-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) is a sequence of brief magnetic pulses that are applied through an air-cooled coil to the section of the head that overlays the motor cortex of the brain.Subjects will be comfortably seated in a dental chair surrounded by a frame that carries a coil holder to assist with the application of TMS to the brain. Low-frequency repetitive transcranial magnetic stimulation (rTMS) will be administered at 1 month and 6 month visit.
16047328|NCT02544503|Device|Sham Motor Cortex Stimulation|Sham motor cortex stimulation will be applied at 1 month and 6 month visit.
16047329|NCT02544477|Device|High-flow Nasal Cannula Oxygen (HFNCO)|
16047330|NCT02544477|Device|Conventional oxygen treatment|
16047331|NCT02544464|Drug|ferric carboxymaltose 1000 mg|Ferric carboxymaltose is administered after anesthesia induction
16047332|NCT02544464|Drug|placebo|placebo (normal saline) is administered after anesthesia induction
16047333|NCT02544451|Drug|LUM/IVA|"Lumacaftor (LUM) 200 mg every 12 hours (q12h)/ivacaftor (IVA) 250 mg q12h (for 6 through 11 years of age).
~LUM 400 mg q12h/IVA 250 mg q12h (for 12 years and older)."
16047334|NCT02544451|Drug|LUM/IVA|LUM 200 mg q12h/IVA 250 mg q12h (for 6 through 11 years of age).
16047335|NCT02544438|Drug|Astarabine (BST-236)|"Cohort # Astarabine Dose Number of Patients
~0.5 gr/m2 (0.3 age>50) 3
~1.5 gr/m2(0.8age>50) 3
~3.0 gr/m2(1.5 age>50) 3
~4.5 gr/m2(2.3 age>50) 6
~4.5 gr/m2 (no age limit) 3 up to 6
~6 gr/m2 (no age limit) 3 up to 6
~Total number of patients: up to 24"
16047336|NCT02544425|Drug|Etoposide|Subjects will receive Etoposide 100 mg/m2 + 5% dextrose in water 500 mL intravenous over 90 mins D1-3 of VIDL chemotherapy. After that, Etoposide will be administered 375mg/m2 D1-2 with G-colony stimulating factor (10 ug/kg) injection in step of Peripheral Blood Stem Cell Collection. Also It will be administered 400mg/m2 on conditioning regimen.
16047337|NCT02544425|Drug|Ifosfamide|It will be administered1.2g/m2 + 5% dextrose in water 100 mL intravenous over 1 hr D1-3
16047338|NCT02544425|Drug|Dexamethasone|It will be administered 40mg/day PO or IV D1-3
16047339|NCT02544425|Drug|L-asparaginase|It will be administered 4000 IU/m2 intramuscular D8, 10, 12, 14, 16, 18, 20
16047340|NCT02544425|Drug|Busulfan|"Conditioning regimen for autologous stem cell transplantation:
~Busulfan 3.2 mg/kg D -8, -7, -6"
16047341|NCT02544425|Drug|Melphalan|"Conditioning regimen for autologous stem cell transplantation:
~Melphalan 70 mg/m2 D -3, -2"
16047342|NCT02544412|Behavioral|novel mindfulness-based well-being training|
16047343|NCT02544399|Other|3D CT scan|Measure of bone micro-architecture by 3D micro-tomography
16047344|NCT02544386|Procedure|MRI and 3D CT scan|Measurement of bone microarchitecture at the legs and wrists by 3D CT Scan and measuring the proportion of fat in the imaging leg bone (MRI)
16047345|NCT02544373|Device|PAP therapy|Positive airway pressure treatment for obstructive sleep apnea
16047346|NCT02544360|Behavioral|Photoaging mobile app promoting poster campaign.|"Schools in this arm receive a photoaging mobile app promoting poster campaign revealing the effects of smoking on the users face via a self portrait (i.e. a selfie)."
16047347|NCT02544347|Other|gingival crevicular fluid|gingival crevicular fluid was collected
16047348|NCT02544347|Other|non-surgical periodontal treatment|scaling and root planing were performed
16047349|NCT02544334|Procedure|Dental Plaque|All participants will have dental plaque removed from different tooth surfaces for supragingival.
16047350|NCT02544334|Other|Multi-dimensional health assessment questionnaire (MDHAQ)|The RA groups will receive the multi-dimensional health assessment questionnaire (MDHAQ) for physical function, pain, and global status.
16047351|NCT02544334|Other|Saliva Collection|All participants will have a saliva collection.
16047352|NCT02544321|Drug|Bromocriptine|
16047353|NCT02544321|Other|Placebo|
16047354|NCT02544308|Drug|Lenalidomide|Experimental Arm
16047355|NCT02544308|Drug|Dexamethasone|Experimental Arm
16047356|NCT02544308|Other|No further treatment|Comparator Arm
16047357|NCT02544295|Behavioral|Clinical interview|
16047358|NCT02544295|Behavioral|Virtual reality task|
16047359|NCT02544282|Drug|Levobupivacaine|Pecs II Block
16047360|NCT02544282|Drug|NaCl 0.9%|Placebo Pecs II block
16047361|NCT02544282|Drug|Sevoflurane|General Anesthesia
16047362|NCT02544282|Drug|Propofol|General Anesthesia
16047363|NCT02544282|Drug|Sufentanil|General Anesthesia
16047364|NCT02544282|Drug|Atracurium|General Anesthesia
16047365|NCT02544282|Drug|Paracetamol|Pain Relief
16047366|NCT02544282|Drug|Tramadol|Pain Relief
16047367|NCT02544282|Drug|Piritramide|Pain Relief
16047368|NCT02544269|Procedure|Ropivacaine|Lumbosacral plexus blockade with ropivacaine.
16047369|NCT02544269|Procedure|Bupivacaine|Regional anesthesia with bupivacaine titrated to the lowest effective dose
16047370|NCT02544256|Procedure|Mild hypothermia|Mild hypothermia during surgical clipping of brain aneurysm will be reached by cooling to body temperature 33,8° C - 34,8° and this temperature maintained up to the end of microcirculation measurement after aneurysm clipping.
16047371|NCT02544243|Drug|Vinorelbine|
16047372|NCT02544243|Drug|Gemcitabine|
16047373|NCT02544243|Drug|Cisplatin|
16047376|NCT02544204|Biological|JVS-100|Biological/Vaccine: JVS-100 Intramuscular Injection
16047377|NCT02544204|Biological|Placebo|Biological/Vaccine: Placebo Intramuscular Injection
16047378|NCT02544191|Drug|GnRHa/ hCG/ hMG|GnRHa was injected subcutaneously at a dose of 3.6mg every 28 days for 5 months. After 2 months from the first GnRHa injection, all subjects were treated with hCG at a dose of 2000 IU once a week for 3 months. After 3 months from the first Goserelin injection, all subjects were treated with hMG at a dose of 150 IU every 3 days for 2 months.
16047379|NCT02544178|Radiation|brain radiotherapy|effect of cerebral radiotherapy on neurocognitive state
16047380|NCT02544165|Dietary Supplement|caffeine intake|The subjects of this group should intake 100 mg of caffeine after the first measurement of haemodynamic parameters with the Finometer device and after the first measurement of the advanced glycation end products accumulation with AgeReader device.
16047381|NCT02544165|Other|cigarette smoking|The subjects of this group should smoke one cigarette after the first measurement of haemodynamic parameters with the Finometer device and after the first measurement of the advanced glycation end products accumulation with AgeReader device.
16047382|NCT02544165|Other|Caffeine intake and Cigarette smoking|The subjects of this group should smoke one cigarette and should consume 100 mg of caffeine after the first measurement of haemodynamic parameters with the Finometer device and after the first measurement of the advanced glycation end products accumulation with AgeReader device.
16047383|NCT02544152|Drug|Lubiprostone|8 mcg administered orally twice daily (BID)
16047384|NCT02544152|Drug|Placebo|Matching placebo, 0 mcg administered orally twice daily (BID)
16047385|NCT02544139|Other|Chagas Detect Plus|
16047386|NCT02544126|Device|Electronic Self-Management Resource Training for Mental Health|eSMART-MH is a software, which is set in a 3-D virtual primary care office environment in which a subject interacts with avatar virtual healthcare staff (medical receptionist, medical assistant, providers, and a virtual healthcare coach). The avatars are programed to behave like humans. The subject moves through the 3-D virtual primary care office and encounters virtual healthcare staff and providers. The subject practices discussing depressive symptoms with avatar healthcare providers and practices self-management skills related to symptoms of depression.The subject also interacts with the health care coach. The health care coach provides the subject with real-time strategies to enhance communication with healthcare providers during their virtual office visit. Overtime, coaching is decreased to build the the subject's self-confidence. eSMART-MH will be used once a month, for three months.
16047533|NCT02543034|Device|Petrolatum Gauze|Gauze dressing
16047387|NCT02544126|Behavioral|Screen-based health education|Screen-based health education will be used and cover topics like depression, nutrition, physical activity, and sleep hygiene at the same frequency as the eSMART-MH intervention, which is used once a month, for three months.
16047388|NCT02544113|Drug|Thymoglobulin|Treatment with thymoglobulin and delayed CNI post OLT
16047389|NCT02544113|Drug|Placebo|Normal transplant immunosuppression
16047390|NCT02544100|Other|Database Entry/Biospecimen Collection|blood, urine, CFS samples and medical data collected
16047391|NCT02544087|Drug|Ixeris of sonchifolia Hance|KDZ40ml+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.
16047392|NCT02544087|Drug|Panax notoginseng saponins|Xueshuantong450mg+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.
16047393|NCT02544087|Drug|Ixeris of sonchifolia Hance combined with Panax notoginseng saponins|KDZ40ml+0.9%N.S.250ml,ivdrip;Xueshuantong450mg+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.
16047394|NCT02544074|Behavioral|neuropsychological testing|standard neuropsychological testing including brief standardized assessments
16047395|NCT02544061|Biological|NM-IL-12|single 12 µg unit subcutaneous (SC) dose of NM-IL-12
16047396|NCT02544061|Drug|Placebo|single subcutaneous dose
16047397|NCT02544035|Other|Type of Toy|Children will be presented with one of three (counterbalanced) toys targeted for their age group. When presented, each target toy will be paired with two additional toys from the same toy category;
16047398|NCT02544035|Other|Play Partner|Each child will first play alone then play with parent.
16047399|NCT02543983|Drug|Ketamine|non-competitive N-methyl-D-aspartate receptor antagonist
16047400|NCT02543957|Procedure|Cholangioscopy|All patients will receive pre-procedural antibiotics per protocol. A blood culture will be drawn from patients prior to the procedure (before antibiotics administration), 5 minutes after the procedure and 30 minutes after the procedure. Patients will be followed up for 7 days after the procedure for fever and or sepsis.
16047401|NCT02543944|Drug|Gabapentin|N-type calcium channel blocker being examined for its potential efficacy to alleviate opioid withdrawal during buprenorphine-assisted detox and transition to depot naltrexone.
16047402|NCT02543944|Drug|Buprenorphine|All participants are stabilized on buprenorphine and then undergo a 10 day taper off buprenorphine.
16047403|NCT02543944|Drug|Clonidine|All participants who successfully taper off buprenorphine receive Clonidine (0.1 mg) prior to induction onto oral naltrexone.
16047404|NCT02543944|Drug|Naltrexone (oral)|All participants receive increasing doses of oral naltrexone over a 3 day period (day 1: 6.25 and 6.25 mg; day 2: 25 mg; day 3: 50 mg)
16047405|NCT02543944|Drug|Naltrexone (depot)|All participants who tolerate oral naltrexone at 50 mg will receive the naltrexone injection on either the same day as the 50 mg dose or the day after.
16047406|NCT02543944|Drug|Placebo|Microcrystalline cellulose
16047407|NCT02543931|Drug|Meriva|Meriva is an enhanced-bioavailability, curcuminoid-enriched turmeric dietary supplement that is sold over the counter in the United States and other countries.
16047408|NCT02543931|Drug|placebo|Placebo capsules containing inert ingredients
16047409|NCT02543918|Drug|Ixekizumab|Administered by SQ injection
16047410|NCT02543918|Drug|Boostrix®|Administered by IM injection
16047411|NCT02543918|Drug|Pneumovax®23|Administered by IM injection
16047412|NCT02543905|Procedure|Prostate MRI and Biopsy|All men will be offered a MRI and prostate biopsy and they can either opt to undergo these procedures at baseline irrespective of PSA level at baseline or they can undergo PSA-only screening until clinically indicated based on an age-defined PSA threshold, at which point, they will undergo prostate MRI and biopsy once their PSA reaches the threshold.
16047413|NCT02543892|Biological|PATH-wSP|Streptococcus pneumoniae Whole Cell Vaccine, Inactivated and Adsorbed to Aluminum Hydroxide
16047414|NCT02543892|Biological|Placebo|Normal Saline
16047415|NCT02543879|Drug|FT-1101|FT-1101 will be supplied as 5 mg, 20 mg or 100 mg capsules and will be administered per the protocol defined frequency and dose level
16047416|NCT02543879|Drug|Azacitidine|Azacitidine will be administered per site's standard of care
16047417|NCT02543866|Biological|Fecal Microbiota Transplantation|Fecal Microbiota Transplantation
16047418|NCT02543853|Other|direct trocar entry|direct trocar entry to provide pneumoperitoneum
16047419|NCT02543853|Other|veres needle entry|veres needle entry to provide pneumoperitoneum
16047420|NCT02543840|Other|Replicating Effective Programs plus External Facilitation|Packaging, training and technical assistance according to the Replicating Effective Programs model plus External Facilitation
16047421|NCT02543840|Other|Educational Materials|Dissemination of educational materials on the collaborative chronic care model for 4 or 8 months prior to cross-over to REP-F
16047422|NCT02543827|Biological|MV140|The subjects will receive daily dose of MV140 during 3 or 6 months
16047423|NCT02543827|Biological|Placebo|The subjects will receive daily dose of placebo during 3 or 6 months
16047424|NCT02543801|Drug|Liposomal Bupivacaine|Periarticular injection
16047425|NCT02543801|Drug|Ropivacaine|Periarticular injection
16047426|NCT02543801|Drug|Bupivacaine|Included as an element of the Liposomal bupivacaine intervention periarticular injection
16047427|NCT02543801|Drug|Clonidine|Included as an element of both interventions as a standard of care periarticular injection
16047428|NCT02543801|Drug|Ketorolac|Included as an element of both interventions as a standard of care periarticular injection
16047429|NCT02543801|Drug|Epinephrine|Included as an element of both interventions as a standard of care periarticular injection
16047430|NCT02543788|Procedure|• Neuro-Ophthalmological examination, Visual Acuity, Fundus, Visual Field, Color Vision, OCT, EDSS • NEI-VFQ 25 and the 10-item • VEPs, p-ERG and mf-ERG|
16047431|NCT02543775|Procedure|Preoperative and intraoperative SLN Mapping|"Patients will undergo preoperative SLN mapping, which includes an injection of a radiocolloid and lymphosinctogram and SPECT/CT. Patients will also receive an intraoperative injection of blue dye. A handheld probe will be utilized to detect radiolabelled or hot nodes and direct visualization will identify blue nodes which will be labelled Sentinel Nodes and sent to pathology for intraoperative frozen section."
16047529|NCT02543060|Drug|stannous fluoride toothpaste|0.454% stannous fluoride toothpaste
16047530|NCT02543060|Drug|cavity protection toothpaste|0.243% sodium fluoride toothpaste
16047432|NCT02543762|Procedure|Chromoendoscopy|Chromoendoscopy involves the topical application of stains to improve tissue localization and characterization of lessions during endoscopy . Chromoendoscopy has been used in patients undergoing colonoscopy, including those undergoing surveillance for chronic ulcerative colitis. Using pit pattern classifications, chromoendoscopy has a high sensitivity and specificity for differentiating neoplastic from non-neoplastic lesions
16047433|NCT02543749|Biological|DC vaccine|Autologous DC pulsed with leukemia-associated peptides+adjuvant
16047434|NCT02543736|Device|Instrumented Treadmill System|Patients will perform twice a gait and a balance analysis on an instrumented treadmill system combined to a photoelectric cell system while controls will only perform once.
16047435|NCT02543723|Behavioral|Nurse Coach Intervention|Participants randomized to the intervention 2 group a tailored nurse coach component. Participants will receive an initial session conducted by the nurse coach, via phone or in-person. Participants will receive weekly phone calls from the nurse coach during the first month of the intervention, and then bi-monthly follow-up calls for the remainder of treatment or 6-month follow-up period (whichever occurs first). The nurse coach will modify the intervention plan to address identified barriers to adherence at this time.
16047436|NCT02543710|Procedure|Biomarker (ER/PR) guided lymphadenectomy|"Lymphadenectomy in the pelvis and para-aortic, will, for patients who are considered otherwise low risk (endometrioid tumours grade 1 or 2, or grade 3 with <50% myometrial infiltration (MI), with no sign of extrauterine disease), be dependent on the preoperative hormone receptor status (ER and PR).
~Patients will be defined low risk when endometrioid, grade 1 or 2, or grade 3 with <50% MI, AND positive hormone receptor status for both ER AND PR. These patients will not undergo lymphadenectomy.
~Patients with endometrioid tumours grade 1 or 2, or grade 3 <50% MI,, with either negative ER or PR status, are defined high risk and will undergo pelvic and para-aortic lymphadenectomy as part of their surgical procedure.
~Patients will receive routine clinical follow-up for 5 years. Follow-up data will be collected for the study, focusing on survival and recurrence of disease. All patients will, as part of the study fill out validated quality of life questionnaires (QoL) at follow-up."
16047437|NCT02543710|Drug|Biomarker guided weekly taxane treatment in endometrial/ ovarian cancer|"A 5mm tissue biopsy will be analysed for stathmin level in the recurrence as well as urine and a second 5mm biopsy on termination of study participation. The second biopsy could help explain why patients have stopped responding to the treatment. Determination of stathmin level both from the tissue and the urine will take place at the pathology department. Stathmin serves as an integrated biomarker, which enables a central biomarker analysis at Haukeland university hospital. Stathmin level is defined as high with an immunohistochemical score 9 (max score). All other scores are considered low. Pre-treatment all patients undergo CT or MRI, maximum 1 month prior to treatment start.
~During treatment, urine and bloods will be collected every treatment cycle (weekly basis). Imaging will take place every 8 treatment cycles. Treatment will continue until disease progression."
16047438|NCT02543697|Radiation|Adrenal venous sampling|We go trough the femoral vein with a catheter up to the adrenal vein first on the left side, then on the right side. We take blood samples and analyze cortisol, metanefrin/ normetanefrin, aldosterone both from the adrenal veins and from the peripher vein. Then we use criteria from the Majo clinic to identify if the overproduction of cortisol is uni- or bilateral.
16047439|NCT02543684|Other|ready to eat mixed meal 1|wild greens pie providing 50g of carbohydrates
16047440|NCT02543684|Other|ready to eat mixed meal 2|chicken burgers with boiled broccoli and cauliflower providing 50g of carbohydrates
16047441|NCT02543684|Other|ready to eat mixed meal 3|vegetable moussaka providing 50g of carbohydrates
16047442|NCT02543684|Other|oral glucose load|glucose load providing 50g of carbohydrates
16047443|NCT02543671|Other|vitamin D3 enriched, reduced-fat yellow cheese|60 grams of vitamin D3 enriched, reduced-fat yellow cheese provide 5.7 micrograms of vitamin D per day for 8 weeks
16047444|NCT02543671|Other|plain (non-fortified) reduced-fat yellow cheese|60 grams of plain (non-fortified), reduced-fat yellow cheese provide 0 micrograms of vitamin D per day for 8 weeks
16047445|NCT02543658|Drug|Neostigmine Methylsulfate 1 MG/ML|The initial dose was 1mg, intramuscular injection(IM) once every 12 hours. If there is no defecation after 12 hours, the dose is increased to 1mg IM once every 8 hours; if there is no defecation after 24 hours, the dose is increased to 1mg IM once every 6 hours. If the abdominal pressure drops below 12mmhg, neostigmine will be stopped, otherwise it will be used continuously for 7 days.
16047446|NCT02543658|Combination Product|Conservative treatment|Intragastric administration of paraffin oil, 50ml,once every 8 hours；gastrointestinal decompression with nasogastric tube and rectal tub; lycerin enema promotes defecation; patients with ascites undergo percutaneous puncture drainage. Other conservative medical treatment recommended by the guidelines.
16047447|NCT02543645|Drug|Combination of Varlilumab and Atezolizumab|"Treatment cycles are 12 weeks each with varlilumab and atezolizumab administered every 3 weeks. During the treatment phase of the study, eligible patients will receive varlilumab for up to 3 cycles (with a 4th cycle possible following discussion with the Medical Monitor). There is no limit on the number of cycles of atezolizumab. Patients may be discontinued from receiving study treatment (atezolizumab or varlilumab) based on the results of disease assessments or if experiencing side effects that make study therapy intolerable.
~Phase l Dose: The planned dose of varlilumab will be dependent on the cohort assigned at enrollment. Varlilumab doses are 0.3 mg/kg, 1 mg/kg, or 3 mg/kg. The dose of atezolizumab is 1200 mg."
16047448|NCT02543632|Device|Parachute Implant System|The CardioKinetix Parachute Implant partitions an enlarged ventricle into dynamic and static chambers. The static chamber is a portion of the left ventricular volume that is taken out of circulation. Stresses placed on the partitioned myocardium and the forces transmitted to the apical segment are decreased both in diastole and systole, eliminating the forces responsible for left ventricular dilation. In addition to this regional unloading, the reduction in size of the dynamic chamber results in a decrease of the myocardial stress in the normal myocardium via Laplace Law, providing a global unloading of the ventricle.
16047449|NCT02543619|Other|Injection technique|One group received Gow-Gates technique and the other group received Infra Alveolar Nerve Block technique for their failed first one anesthesia
16047450|NCT02543606|Drug|Esomelone|powder for injection/ infusion Esomeprazole 40mg
16047451|NCT02543606|Drug|Nexium|powder for injection/ infusion Esomeprazole 40mg
16047531|NCT02543047|Device|Angioshield|Angioshield is applied to vein graft to provide Mechanical Support for Vein Grafts Used in CABG Surgery
16047532|NCT02543034|Device|Betafoam Wound Dressing|Foam dressing including Betadine iodine
16047452|NCT02543593|Device|Active tDCS or Sham tDCS|tDCS is a painless technique which consists in applying low direct-current through electrodes (one electrode serving as an anode, the other as a cathode) placed on the scalp to target the cerebral cortex. In patients with chronic pain, the anode is commonly placed over the motor cortex (M1) (Valeriani et al., 1999).
16047453|NCT02543580|Other|transcutaneous electric acupoint stimulation|electrodes are attached o the skin and electric stimulation is given
16047454|NCT02543580|Other|electrode attached but no stimulation|electrodes are attached o the skin but no stimulation is given
16047455|NCT02543567|Biological|Ad26.ZEBOV 5*10^10 viral particles (vp)|Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 5*10^10 viral particles on Day 1
16047456|NCT02543567|Biological|Ad26.ZEBOV 2*10^10 (vp)|Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 2*10^10 viral particles on Day 1
16047457|NCT02543567|Biological|Ad26.ZEBOV 0.8*10^10 (vp)|Ad26.ZEBOV, live, replication incompetent vaccine, sterile suspension for intramuscular (IM) injection of 0.8*10^10 viral particles on Day 1
16047458|NCT02543567|Biological|MVA-BN-Filo 1*10^8 Infectious Unit [Inf. U.]|MVA-BN-Filo- live replication incompetent vaccine, IM injection of 1*10^8 Infectious Unit [Inf. U.] once on Day 57
16047459|NCT02543567|Biological|MVA-BN-Filo 5*10^7 Inf. U.|MVA-BN-Filo- live replication incompetent vaccine, IM injection of 5*10^7 Inf. U. once on Day 57
16047460|NCT02543567|Biological|Placebo|One 0.5 ml IM injection of 0.9% saline administered once on Day 1 and Day 57
16047461|NCT02543554|Procedure|lung protective ventilation|Lung protective ventilation strategy, which aims to deliver safe tidal volumes, appropriate PEEP, limit plateau pressure, and limit hyperoxia.
16047462|NCT02543541|Behavioral|Structured palliative care|Supportive care for the patient and caregiver will be provided by the outpatient palliative care team which includes clinicians with specialized palliative care training, social workers, spiritual care specialists and mental health clinical nurse specialist.
16047463|NCT02543541|Behavioral|Standard supportive care|Supportive care for the patient and caregiver will be provided by the treating oncologist.
16047464|NCT02543528|Device|Investigational Lens 1|One fresh pair of Investigational Lens 1 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.
16047465|NCT02543528|Device|Investigational Lens 2|One fresh pair of Investigational Lens 2 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.
16047466|NCT02543528|Device|Investigational Lens 3|One fresh pair of Investigational Lens 3 contact lenses worn continuously in 6 nights/7 days wear cycles for 6 months of total wear.
16047467|NCT02543528|Device|etafilcon A (Reusable)|One fresh pair of etafilcon A (Reusable) contact lenses worn continuously in 6nights/7 days wear cycles for 6 months of total wear.
16047468|NCT02543528|Device|etafilcon A (1-Day)|2-week contact lens adaptation period wearing prior to randomization
16047469|NCT02543515|Procedure|office hysteroscopy|diagnostic procedure
16047470|NCT02543502|Procedure|periodontal treatment|treatment of periodontal cleaning
16047471|NCT02543489|Device|Flex IM rod|
16047472|NCT02543463|Device|Trident X3 Insert with Navigation system|
16047473|NCT02543463|Device|Trident X3 Insert with conventional instrumentation|
16047474|NCT02543450|Other|Cardiovascular and task-oriented training|
16047475|NCT02543450|Other|Upper limb strength training program|
16047476|NCT02543437|Device|Trident Acetabular X3 Insert|
16047477|NCT02543424|Behavioral|Motor, cognitive and neuropsychological assessment|Cognitive and motor testing and/or experimental cognitive or motor changes and/or cognitive or motor rehabilitation depending on part of the study investigated.
16047478|NCT02543411|Drug|Lidocaine 1%|"Intravenous administration as bolus of lidocaine 1.5 mg/kg before sedation and infusion of lidocaine 2 mg/kg/hr during sedation.
~Sedation with fentanyl and propofol"
16047479|NCT02543411|Drug|Normal saline|"Intravenous administration as bolus of normal saline 0.15 mL/kg before sedation and infusion of normal saline 0.2 mL/kg/hr during sedation.
~Sedation with fentanyl and propofol"
16047480|NCT02543398|Procedure|Ridge preservation|Ridge preservation is a procedure which consists in grafting the tooth extraction socket with a bone grafting material and cover the site with a membrane to protect the site.
16047481|NCT02543385|Drug|S Ketamine|S+ketamine will be given in group I only in the doses of 0.25mg/kg (iv bolus) before induction along with midazolam and 0. 25 mg/kg (iv bolus) 20 minutes prior to extubation
16047482|NCT02543372|Behavioral|Behavioral Couples Therapy (BCT)|BCT integrates cognitive behavioral techniques targeting problem gambling with a large focus on interventions for relationship functioning. The BCT condition requires active participation from both the gambler and the CSO.
16047483|NCT02543372|Behavioral|Cognitive Behavioral Therapy (CBT)|The CBT integrates cognitive behavioral techniques targeting problem gambling with some interventions for relationship functioning.The CBT condition requires active participation from the gambler, but not for the CSO.
16047484|NCT02543359|Behavioral|Training Models of PCIT|Agency participants are trained in one of three training model strategies: Train the Trainer Model (TTT), Learning Collaborative (LC), or Web-Supported Self Study (SS).One third of participating agencies will be randomized to the Train the Trainer training model.One third of participating agencies will be randomized to the Learning Collaborative training model.One third of participating agencies will be randomized to the Web-Supported Self Study.
16047485|NCT02543359|Behavioral|Training Models of PCIT|One-third of administrators are trained in the Learning Collaborative training model. One-third of administrators will be trained to usual treatment (none). One-third of administrators will be trained to usual treatment (none).
16047486|NCT02543359|Behavioral|Parent-Child Interaction Therapy (PCIT) Treatment|Parent-Child Interaction Therapy (PCIT), a parent coaching evidence-based protocol is given to each family from clinicians and supervisors in each training model.
16047487|NCT02543346|Drug|Cetirizine|Participants will receive either cetirizine (10mg tablet, orally) or a placebo (sugar pill) at one of the two treatment visits.
16047488|NCT02543346|Other|Placebo|Participants will receive either a placebo or cetirizine (10mg tablet, orally) at one of the two treatment visits
16047489|NCT02543320|Other|LORETA Neurofeedback Training|Undergo LORETA neurofeedback training
16047490|NCT02543320|Other|Questionnaire Administration|Ancillary studies
16047491|NCT02543307|Procedure|Nurse-led Patient Pathways|The NPP include a comprehensive needs and goal assessment. Patients appreciated written information provided at an early stage of their hospital stay that helped to prepare them for discharge. The NPP continue with pre- and post-operative patient care, and conclude with a newly implemented follow-up phone call after hospital discharge. Nursing interventions were presented in a checklist format, based on scientific and clinical evidence. The NPP were developed with regard to patient and family centered goals and objectives and were explicitly emphasized in the NPP. NPP guided the nursing care plan. Nurses act as advocates for patients' interests. Therefore NPPs represent a means to formalize these nursing activities and contribute to transparency in relation to other health professionals.
16047492|NCT02543294|Device|Echocardiograms|Participants undergo echocardiograms with contrast done at baseline and at months 2, 4, 6, 12, 18, and 30.
16047493|NCT02543294|Device|Electrocardiogram|Electrocardiogram performed at baseline.
16047494|NCT02543294|Behavioral|Symptom Questionnaire|Symptom questionnaire completed at baseline and at months 1, 2, 4, 6, 12, 18, and 30.
16047495|NCT02543294|Behavioral|Telephone Follow-Up|Telephone follow-up by study staff at months 3 and 5.
16047496|NCT02543281|Device|Adaptive cardiac resynchronization therapy|The adaptive cardiac resynchronization therapy (aCRT) algorithm works by sometimes giving stimulation to only the left side of the heart, rather than to both sides, depending on how it senses the heart is functioning.
16047497|NCT02543281|Device|Conventional Cardiac Resynchronization Therapy|CRT without the adaptive algorithm works by giving stimulation to both sides of the heart.
16047498|NCT02543268|Biological|Ad26.ZEBOV-Batch #1|Ad26.ZEBOV - Batch #1, live, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5*10^10 viral particles on Day 1
16047499|NCT02543268|Biological|Ad26.ZEBOV-Batch #2|Ad26.ZEBOV - Batch #2, live, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5*10^10 viral particles on Day 1
16047500|NCT02543268|Biological|Ad26.ZEBOV-Batch #3|Ad26.ZEBOV - Batch #3, live, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5*10^10 viral particles on Day 1
16047501|NCT02543268|Biological|MVA-BN-Filo|MVA-BN-Filo- live replication incompetent vaccine, 0.5 mL IM injection of 1*10^8 Infectious Unit [Inf. U.] once on Day 57.
16047502|NCT02543268|Biological|Placebo|One 0.5 ml IM injection of 0.9% saline once on Day 1 and Day 57.
16047506|NCT02543242|Device|InToneTM (InControl Medical, LLC) - Medical Device|
16047507|NCT02543229|Drug|OPT-302|OPT-302 will be administered by intravitreal injection once every month for 3 months
16047508|NCT02543229|Drug|Lucentis™|Lucentis™ (0.5 mg) will be administered by intravitreal injection once every month for 3 months
16047509|NCT02543216|Dietary Supplement|Sunflower oil|Study diets were isocaloric following the habitual diet of the participants with a supplement of 30-50 ml (25-45 g) sunflower oil daily depending on body weight. Thus, approximately 16-28 g (6 E%) LA were provided daily on top of the average intake of approximately 10-12 g (4.5 E%).
16047510|NCT02543203|Biological|Reconnect|Topical Essential Oils mixture and aromatic method
16047511|NCT02543203|Biological|Coconut oil Comparator|Topical Essential Oils mixture and aromatic method
16047512|NCT02543190|Behavioral|compliance surveillance and improvement strategy|External monitor to ensure compliance with an educational protocol.
16047513|NCT02543177|Procedure|coronary angiography|
16047514|NCT02543177|Procedure|ischemic precondition|four cycles of congestion and flow of blood in the arm of the patient for 5 minutes
16047515|NCT02543177|Procedure|prior kidney irrigation|
16047516|NCT02543164|Other|REFERENCE: white bread|"Determination of glycemic response after consumption of white bread:
~Capillary glucose will be taken at 0 min (baseline sample), followed by 15, 30, 45, 60, 90 and 120 min after starting to eat the meal to calculate the area under the curve (AUC)."
16047517|NCT02543164|Other|TEST: b-glucan enriched bread|"Determination of glycemic response after consumption of bread enriched with barley beta-glucans (Test A) :
~Capillary glucose will be taken at 0 min (baseline sample), followed by 15, 30, 45, 60, 90 and 120 min after starting to eat the meal to calculate the area under the curve (AUC)."
16047518|NCT02543151|Procedure|SpyGlass (direct visualization system) choledochoscopy|SpyGlass (direct visualization system) choledochoscopy procedure will be performed pre and post biliary complication treatment
16047519|NCT02543138|Device|Trocar|Closed thoracostomy using the new trocar
16047520|NCT02543125|Device|NIPPV|"For infants in the NIPPV-group who failNIPPV (see definition below), need immediate intubation, a invasive Rescue-Treatment may be provided. The decision to attempt Rescue-Treatment, the mode of respiratory support and the ventilator settings used are at the discretion of the attending clinician."
16047521|NCT02543125|Device|NHFOV|"For infants in the NHFOV-group who failNHFOV (see definition below), need immediate intubation, a invasive Rescue-Treatment may be provided. The decision to attempt Rescue-Treatment, the mode of respiratory support and the ventilator settings used are at the discretion of the attending clinician."
16047522|NCT02543099|Drug|policosanol|Patients will receive policosanol 20mg Qd
16047523|NCT02543099|Drug|placebo|Patients will receive placebo 20mg Qd;
16047524|NCT02543086|Drug|KAE609|Study drug
16047525|NCT02543086|Drug|Piperaquine Phosphate|Pre-administration of Piperaquine Phosphate will be done to eliminate the asexual form of the parasite and induce gametocytaemia before characterizing the activity of KAE609 in clearing sexual blood stage parasites from the blood of healthy subjects in the Induced Blood Stage Malaria Challenge model in Part B of study
16047526|NCT02543073|Biological|MSCs|MSCs will be given at a median dose of 1×10^6 cells/kg once weekly for 4 weeks as one cycle treatment.
16047527|NCT02543073|Drug|AZM|AZM will be given （0.25g qd）for 4 weeks as one cycle treatment.
16047528|NCT02543073|Drug|Glucocorticoid|Glucocorticoid (prednison) will be given at the starting dose of 1mg/kg for 4 weeks as one cycle treatment.
16047534|NCT02543034|Device|Allevyn Wound Dressing|Foam dressing
16047535|NCT02543021|Device|Virtual chromoendoscopy|Digital / virtual chromoendoscopy with FICE
16047536|NCT02543021|Procedure|Conventional chromoendoscopy|Conventional chromoendoscopy with indigo carmine dye spray
16047537|NCT02543008|Procedure|Physical activity plus thoracic mobilization|Information already included in arm/group descriptions.
16047538|NCT02543008|Procedure|Physical activity|Information already included in arm/group descriptions.
16047539|NCT02543008|Procedure|Placebo|Information already included in arm/group descriptions.
16047540|NCT02542995|Other|QI interventions|Intervention categories: communication improvement, chronic disease QI projects (for patients), workflow redesign
16047541|NCT02542982|Device|tDCS (Endomed 482; Enraf-Nonius B.V.)|non-invasive brain stimulation with pair of electrodes with saline-soaked pads through which the direct current of intensity of 2 mA is delivered
16047542|NCT02542969|Drug|Simvastatin|
16047543|NCT02542969|Drug|Rosuvastatin|
16047544|NCT02542969|Drug|MGL-3196|
16047545|NCT02542956|Drug|Exparel|receive Exparel by injection
16047546|NCT02542956|Drug|Marcaine|receive Marcaine in a pain pump
16047547|NCT02542956|Drug|Marcaine|receive Marcaine by injection
16047548|NCT02542943|Device|Experimental Oral Rinse 1|(1.5% w/w KOX, pH 4.5)
16047549|NCT02542943|Device|Experimental Oral Rinse 2|(1.5% w/w KOX, pH 7)
16047550|NCT02542943|Other|Placebo Oral Rinse|(0% w/w KOX, pH 4.5)
16047551|NCT02542943|Drug|Standard fluoride toothpaste|1000ppm fluoride as sodium monofluorophosphate
16047552|NCT02542930|Radiation|Radiotherapy|Metastatic lesions of Non-small cell lung cancer receiving 3.5Gy per fraction to a total dose of 35Gy/10 fractions over 2 weeks with concurrent thymalfasin.
16047553|NCT02542930|Drug|Thymalfasin|Metastatic lesions of Non-small cell lung cancer receiving 3.5Gy per fraction to a total dose of 35Gy/10 fractions over 2 weeks with concurrent thymalfasin; Thymalfasin treatment is given twice a week with an interval of 3-4 days each week.
16047554|NCT02542917|Device|IBDoc home test for faecal calprotectin|IBDoc home test for faecal calprotectin
16047555|NCT02542904|Procedure|mesenteric excision|
16047556|NCT02542891|Other|Blended CBT|
16047557|NCT02542891|Other|Treatment as Usual (TAU)|
16047558|NCT02542878|Device|Foam roller|A bout of 60 seconds of myofascial release with foam roller
16047559|NCT02542865|Dietary Supplement|Fortified malt based food|Fortified malt based food
16047560|NCT02542852|Drug|atazanavir 300 mg + ritonavir 100 mg + dolutegravir 50 mg|Switch to single arm treatment atazanavir-ritonavir 300-100 mg + dolutegravir 50 mg therapy for 24 weeks
16047561|NCT02542839|Device|NeuroStar TMS therapy|Application of repetitious transcranial magnetic stimulation (TMS) pulses using NeuroStar device to a specific brain target at predefined stimulation parameters.
16047562|NCT02542839|Device|Sham NeuroStar TMS therapy|Same procedure as real rTMS without stimulating the cerebral cortex.
16047563|NCT02542839|Other|Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)|All participants will receive a clinical assessment of dystonia severity by using the TWSTRS test.
16047564|NCT02542839|Other|Craniocervical Dystonia Questionnaire (CDQ-24)|All participants will fill out the Craniocervical Dystonia Questionnaire (CDQ-24) quality of life questionnaire.
16047565|NCT02542839|Other|Cerebellar-brain Inhibition (CBI)|All participants will have a measure of the cerebellar-brain inhibition(CBI) which will be conducted by using a TMS device determining the ability of the coil to activate the cerebellum.
16047566|NCT02542839|Procedure|Botulinum toxin injections|All participants will receive Botulinum toxin(BoNT) injections as part of their standard of care
16047567|NCT02542826|Other|Pulmonary Rehabilitation|Patients will participate in 3 exercise training sessions/wk for a period of 7-12 wks at one of 4 sites in Quebec. Each training session will include 30-45 min of aerobic training (cycling and/or treadmill walking) at a target intensity of 80% of the maximal heart rate achieved during a symptom-limited incremental cycle exercise test performed prior to the pulmonary rehabilitation program; and 20-30 min of strength training exercises.
16047568|NCT02542813|Drug|IM oxytocin 10 IU|IM oxytocin 10 IU is a colourless and clear sterile solution in a 1 mL ampoule containing 10 IU of oxytocin, which is administered intramuscularly
16047569|NCT02542813|Drug|IH oxytocin 50 mcg|IH oxytocin 50 mcg is a powder blend for inhalation in a hard capsule containing 50 mcg of oxytocin, which is administered by oral inhalation.
16047570|NCT02542813|Drug|IH oxytocin 200 mcg|IH oxytocin 200 mcg is a powder blend for inhalation in a hard capsule containing 200 mcg of oxytocin, which is administered by oral inhalation.
16047571|NCT02542813|Drug|IH oxytocin 400 mcg|IH oxytocin 400 mcg is a powder blend for inhalation in a hard capsule containing 400 mcg of oxytocin, which is administered by oral inhalation.
16047572|NCT02542813|Drug|IH oxytocin 600 mcg|IH oxytocin 600 mcg is a powder blend for inhalation in a hard capsule containing 600 mcg of oxytocin, which is administered by oral inhalation.
16047573|NCT02542813|Drug|Placebo|Placebo is a powder blend for inhalation in a hard capsule containing five inactive components, which is administered by oral inhalation.
16047574|NCT02542800|Behavioral|Episodic memory task|
16047575|NCT02542800|Device|fMRI|
16047576|NCT02542787|Drug|VSN16R|Small molecule
16047577|NCT02542787|Other|Placebo|dummy tablet
16047578|NCT02542774|Other|No intervention is given.|This study is based on the analysis of linked electronic health records (CALIBER dataset)
16047579|NCT02542761|Device|Fiberglass Composite foot|The Rush foot is a fiberglass composite energy storage and return prosthetic foot.
16047580|NCT02542761|Device|Carbon Fiber Composite Foot|All types of currently commercially available carbon fiber energy storage and return prosthetic feet will be considered appropriate.
16047581|NCT02542748|Drug|Norepinephrine|norepinephrine injection
16047582|NCT02542748|Drug|Ephedrine|Ephedrine injection
16047583|NCT02542722|Behavioral|Control|General recommendations about a healthy diet and physical activity and referral to their general physician with a report of the study results in the event of detecting any risk factor or pathological finding
16047669|NCT02542098|Drug|HYD tablets|Hydrocodone bitartrate 20 mg to 120 mg extended-release tablets.
16047670|NCT02542085|Procedure|Laparoscopic repair|operative method
16047671|NCT02542085|Procedure|Hybrid repair|operative method
16047584|NCT02542722|Behavioral|Intensive Intervention|Based on office visits each 3 months during the first year, as well as monthly telephone calls during the first year. Each subject will also attend a group educational meeting each 6 months. At each visit they will be given a series of recommendations and their degree of adherence evaluated and the evolution of their weight checked. The recommendations are designed to re-educate the subjects concerning their dietary and physical activity habits
16047585|NCT02542709|Device|Active repetitive Transcranial Magnetic Stimulation|Active transcranial magnetic stimulation will induce real pulses using the transcranial magnetic stimulation device.
16047586|NCT02542709|Device|Sham repetitive Transcranial Magnetic Stimulation|Sham transcranial magnetic stimulation will not induce any pulses using the same transcranial magnetic stimulation device but by also adding a sham block device.
16047587|NCT02542696|Drug|APL-130277|"Used to treat up to 5 OFF episodes per day"
16047588|NCT02542683|Other|structured physical activity program|a structured modest physical activity program
16047589|NCT02542670|Genetic|Whole genome sequencing|At least 50 ng of tumor DNA will be extracted from FFPE samples and/or fresh tissue and used for hybridization capture and NGS using the IlluminaMiSeqDx platform.
16047590|NCT02542657|Drug|Clarithromycin|Given PO
16047591|NCT02542657|Drug|Dexamethasone|Given PO
16047592|NCT02542657|Drug|Ixazomib Citrate|Given PO
16047593|NCT02542657|Drug|Pomalidomide|Given PO
16047594|NCT02542644|Device|Ultrahigh resolution Spectral Domain OCT|"The area of graft detachment will be measured by a customized ultra high-resolution OCT for the cornea.
~A spectrometer based ultrahigh resolution Spectral Domain OCT (SDOCT) system operating at 800 nm for the anterior chamber will be employed in the present study. The spectrum of the Ti:Sapphire laser light source is centered at 800 nm. With a full width at half maximum bandwidth of 170 nm, the axial resolution is 1.3 μm in the cornea. The transverse resolution of the employed OCT system is 21 μm at the front surface of the cornea. For measurement, patients will place their head in a modified slit lamp head rest. During the measurement period, patients will be asked to look straight forward onto an internal fixation target and to avoid blinking. Different scattering patterns, e.g. raster, circular and spiral scans will be employed."
16047595|NCT02542631|Device|Bolus Insulin Patch (Calibra Finesse)|
16047596|NCT02542631|Device|Insulin Pen (Novo-Nordisk FlexPen®)|
16047597|NCT02542618|Behavioral|Inquiry Based Stress Reduction (IBSR)|
16047598|NCT02542618|Behavioral|Cognitive Behavioral Therapy (CBT)|
16047599|NCT02542605|Drug|Erenumab|Administered once on day 1 of Part B of the study by intravenous infusion.
16047600|NCT02542605|Drug|Placebo|Administered once on day 1 of Part B of the study by intravenous infusion.
16047601|NCT02542605|Drug|PACAP-38 Challenge Agent|"Administered by intravenous infusion during Part A of the study for dose selection for Part B.
~Administered by intravenous infusion on day 8 in Part B as a challenge agent to induce a migraine-like attack."
16047602|NCT02542592|Drug|Methylprednisolone|Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride (placebo)
16047603|NCT02542592|Drug|Isotonic Sodium Chloride|Placebo
16047604|NCT02542579|Genetic|16S rRNA pyrosequencing analysis|Next generation sequencing analysis will be done for 16S rRNA V1,2 hypervariable regions at Biocore (Seoul, Korea).
16047605|NCT02542566|Procedure|Physiotherapy rehabilitation|Physiotherapy rehabilitation
16047606|NCT02542553|Procedure|Bilateral BAL|
16047607|NCT02542540|Other|Training with Nintendo Wii console|Children with OI and draining for 3 months using Nintendo Wii console
16047608|NCT02542527|Procedure|Fluid filled breast pump|breast milk pumping with a fluid filled breast pump
16047609|NCT02542514|Drug|Ibrutinib|p.o. 560 mg once a day (four 140 mg capsules) for one year (12 cycles of 28 days)
16047610|NCT02542488|Other|STOPBANG Questionnaire|"8 question screening tool comprised of the following questions:
~S: Do you Snore loudly? T: Do you often feel tired during daytime? O: Has anyone observed you stop breathing during your sleep? P: Do you have high blood pressure? B: Is your BMI >35 kg/m2? A: Are you >50 years old? N: Is your neck circumference >40cm? G: Is your gender male?"
16047611|NCT02542488|Diagnostic Test|Overnight pulse oximetry|All participants will be given a Masimo Rad8 pulse oximeter to take home and apply to their finger overnight to measure their heart rate and oxygen saturations while they sleep.
16047612|NCT02542488|Other|Epworth Sleepiness Scale|A questionnaire that rates how tired they are doing everyday tasks
16047613|NCT02542475|Device|Low Field Magnetic Stimulation|The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain. The field and timing parameters of the LFMS pulses, such as pulse timing, duration, frequency, and electric and magnetic field distribution and direction are different from other neurostimulation methods. LFMS electromagnetic fields are significantly weaker (< 100x) than those used in ECT and rTMS.
16047614|NCT02542462|Drug|Rotarix®,|Single oral dose of licensed rotavirus vaccine given alone
16047615|NCT02542462|Drug|Rotarix®, with other routine vaccines|Single oral dose of licensed rotavirus vaccine given with other routine vaccines
16047616|NCT02542462|Drug|RotaTeq®,|Single oral dose of licensed rotavirus vaccine given alone
16047617|NCT02542462|Drug|RotaTeq®, with other routine vaccines|Single oral dose of licensed rotavirus vaccine given with other routine vaccines
16047618|NCT02542449|Dietary Supplement|Globes®|At the end of a 3-month lifestyle intervention, all participants received twice a day for 3 months Globes® and attended a monthly clinical visit during the supplementation period and 3 months after the end of supplementation.
16047619|NCT02542449|Dietary Supplement|Placebo|At the end of a 3-month lifestyle intervention, all participants received twice a day for 3 months placebo and attended a monthly clinical visit during the supplementation period and 3 months after the end of supplementation.
16047620|NCT02542436|Other|No intervention|No intervention administered in this study
16047621|NCT02542423|Other|Endocan blood test samples|
16047622|NCT02542410|Drug|Cabergoline|
16047623|NCT02542410|Drug|Norethindrone acetate|
16047624|NCT02542397|Genetic|Pharmacogenomic Testing|Pharmacogenomic test results to guide drug/dose modifications
16047672|NCT02542072|Device|comfilcon A|contact lens
16047673|NCT02542072|Device|samfilcon A|contact lens
16047674|NCT02542059|Radiation|68Ga-exendin PET/CT|68Ga-exendin PET/CT
16047625|NCT02542384|Drug|CR845 IV 1 mcg/kg|"CR845 IV 1 mcg/kg will be administered as an IV bolus 2x loading dose one hour prior to anesthetic induction for surgery, then a dose within 30 minutes of the patient being considered stable in the post operative recovery room. Subsequent dosing will be administered at 6, 12 and 18 hours.
~Antinausea rescue medication (ondansetron 4 mg IV) may be requested, as well as analgesic rescue medication (morphine 5mg IV), post surgery, as needed. Saline infusion (IV 0.45%) for fluid replenishment will be provided."
16047626|NCT02542384|Drug|CR845 IV 0.5 mcg/kg|"CR845 IV 0.5 mcg/kg will be administered as an IV bolus 2x loading dose one hour prior to anesthetic induction for surgery, then a dose within 30 minutes of the patient being considered stable in the post operative recovery room. Subsequent dosing will be administered at 6, 12 and 18 hours.
~Antinausea rescue medication (ondansetron 4 mg IV) may be requested, as well as analgesic rescue medication (morphine 5mg IV), post surgery, as needed.
~Saline infusion (IV 0.45%) for fluid replenishment will be provided."
16047627|NCT02542384|Drug|Placebo IV|"Placebo IV will be administered as an IV bolus 2x loading dose one hour prior to anesthetic induction for surgery, then a dose within 30 minutes of the patient being considered stable in the post operative recovery room. Subsequent dosing will be administered at 6, 12 and 18 hours.
~Antinausea rescue medication (ondansetron 4 mg IV) may be requested, as well as analgesic rescue medication (morphine 5mg IV), post surgery, as needed.
~Saline infusion (IV 0.45%) for fluid replenishment will be provided."
16047628|NCT02542371|Other|Arterial Imaging|
16047629|NCT02542345|Procedure|magnetic resonance imaging|
16047630|NCT02542332|Other|With Data|The participants received statistical data about lung cancer screening in order to help them answer the questionaire
16047631|NCT02542319|Dietary Supplement|Mablet 360 mg|
16047632|NCT02542319|Dietary Supplement|Placebo|
16047633|NCT02542306|Drug|fibrinogen concentrate|Investigators administered fibrinogen concentrate when the plasma fibrinogen level was below 1.5 g/L at 5 minutes after protamine reversal and completion of surgical hemostasis in patients, who comprised the fibrinogen concentrate-treated group.
16047634|NCT02542293|Biological|Durvalumab +Tremelimumab|
16047635|NCT02542293|Drug|Paclitaxel + carboplatin|Chemotherapy Agents
16047636|NCT02542293|Drug|Gemcitabine + cisplatin|Chemotherapy Agents
16047637|NCT02542293|Drug|Gemcitabine + carboplatin|Chemotherapy Agents
16047638|NCT02542293|Drug|Pemetrexed + cisplatin|Chemotherapy Agent
16047639|NCT02542293|Drug|Pemetrexed + carboplatin|Chemotherapy Agent
16047640|NCT02542280|Procedure|endometrial injury.|Endometrial injury using a pipelle biopsy catheter on day (5, 6 or 7) of the stimulation cycle combined with the intrauterine insemination.
16047641|NCT02542280|Procedure|intrauterine insemination|Placement of washed sperm in the uterus using a catheter, around the time of ovulation.
16047642|NCT02542280|Drug|ovarian stimulation|Inducing ovulation by human menopausal gonadotrophin ampoules given intramuscular starting from cycle day two, till the leading follicle reaches 16 - 18 mm.
16047643|NCT02542267|Device|Gore VIABAHN Endoprosthesis|
16047644|NCT02542254|Drug|Salbutamol|200 micrograms salbutamol administered using a pressurised metered dose inhaler (pMDI)
16047645|NCT02542254|Drug|Ipratropium|40 micrograms ipratropium administered using a pMDI
16047646|NCT02542254|Drug|RPL554|6 mg RPL554 administered using a nebuliser
16047647|NCT02542254|Drug|Salbutamol matched placebo|Placebo pMDI
16047648|NCT02542254|Drug|Ipratropium matched placebo|Placebo pMDI
16047649|NCT02542254|Drug|RPL554 matched placebo|Nebulised placebo
16047650|NCT02542241|Drug|Sodium Chloride [3%]|Patients in this arm will receive an intravenous infusion of 3% hypertonic saline at a 50 cc/hour rate, which will be administered by an infusion pump during the first 72 hours after the damage control surgery. A total of 3600cc will be administered throughout 72 hours ( 1200cc every 24 hours).
16047651|NCT02542241|Drug|Sodium Chloride [0.9%]|Patients in this arm will receive an intravenous infusion of 0.9% hypertonic saline at a 50 cc/hour rate, which will be administered by an infusion pump during the first 72 hours after the damage control surgery. A total of 3600cc will be administered throughout 72 hours ( 1200cc every 24 hours).
16047652|NCT02542228|Other|questionnaire survey|The HR-QOL PIDD survey will be administered to the patient by the site PI or the study coordinator. A second survey will be handed to the patient to take home with them and completed at 48-120 hrs. after the clinic visit. The study coordinator will contact the patient during this period to ensure that the patient completes this second survey and returns it to the local study site. A case report form (CRF) of their clinical condition and demographics will be collected at the time of informed consent.
16047653|NCT02542215|Drug|Cobiprostone|Cobiprostone 30 mcg oral spray
16047654|NCT02542215|Drug|Placebo|Matching placebo oral spray
16047655|NCT02542215|Drug|Standard Care - Chemotherapy|Chemotherapy, as given with radiation as standard care for patients with head and neck cancer.
16047656|NCT02542215|Radiation|Standard Care - Radiation|Radiation, as given with chemotherapy as standard care for patients with head and neck cancer.
16047657|NCT02542202|Radiation|Stereotactic Body Radiation Therapy|Undergo stereotactic body radiation therapy
16047658|NCT02542176|Other|Freeze-dried Whole Grape Powder|60 g of whole grape powder for 4 weeks
16047659|NCT02542176|Other|Grape Powder Placebo|60 g of grape powder placebo for 4 weeks
16047660|NCT02542150|Drug|acetate|acetate infusion, saline infusion, functional magnetic resonance imaging (fMRI) scan
16047661|NCT02542150|Drug|alcohol|"a jello shot containing alcohol, a jello shot containing no alcohol, fMRI scan."
16047662|NCT02542137|Radiation|Radiotherapy|3.5Gy per fraction to a total dose of 35Gy/10 fractions over 2 weeks with concurrent thymalfasin for metastatic lesions of small cell lung cancer.
16047663|NCT02542137|Drug|Thymalfasin|Patients with metastatic lesions of small cell lung cancer receiving 3.5Gy per fraction to a total dose of 35Gy/10 fractions over 2 weeks with concurrent thymalfasin ( given twice a week with an interval of 3-4 days each week).
16047664|NCT02542124|Biological|NM-IL-12 and TSEBT|The LD-TSEBT treatment will start on Day 1 of the study. NM-IL-12 will be administered subcutaneously.
16047665|NCT02542111|Drug|Bortezomib|Bortezomib IV
16047666|NCT02542111|Drug|Gemcitabine|Gemcitabine IV
16047667|NCT02542111|Drug|Dexamethasone|Dexamethasone IV
16047668|NCT02542111|Drug|Cisplatin|Cisplatin IV
16048918|NCT02532855|Drug|Sitagliptin|Sitagliptin 100 mg oral tablet
16047675|NCT02542046|Drug|Barium|Administration of barium oral contrast agent prior to CT scan
16047676|NCT02542046|Drug|Diatrizoate|Administration of diatrizoate oral contrast agent prior to CT scan
16047677|NCT02542046|Drug|Iohexol|Administration of iohexol oral contrast agent prior to CT scan
16047678|NCT02542033|Other|treated apple juice with low sugar content|Each study participant consumed 500 mL test juice at the morning of the interventional day. The 500 mL bottle content had to be ingested within 5 minutes. an intravenous catheter was inserted into a forearm vein for blood withdrawal at baseline, directly before (time point 0) and 15, 30, 45, 60, 90 and 120 minutes after starting the ingestion of the test product. From all samples plasma insulin was measured. From the blood samples taken at baseline and 120 minutes after consumption of the test product safety parameters were determined. Capillary blood was taken from the finger pad using a HemoCue® Safety Lancet at baseline (twice) and once directly before (time point 0) and 15, 30, 45, 60, 90 and 120 minutes after ingestion of the test product.
16047679|NCT02542033|Other|un-treated apple juice with normal sugar content|Each study participant consumed 500 mL test juice at the morning of the interventional day. The 500 mL bottle content had to be ingested within 5 minutes. an intravenous catheter was inserted into a forearm vein for blood withdrawal at baseline, directly before (time point 0) and 15, 30, 45, 60, 90 and 120 minutes after starting the ingestion of the test product. From all samples plasma insulin was measured. From the blood samples taken at baseline and 120 minutes after consumption of the test product safety parameters were determined. Capillary blood was taken from the finger pad using a HemoCue® Safety Lancet at baseline (twice) and once directly before (time point 0) and 15, 30, 45, 60, 90 and 120 minutes after ingestion of the test product.
16047680|NCT02542007|Device|OrbusNeich Combo stent™|The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.
16047681|NCT02542007|Device|sirolimus-eluting stent system|
16047682|NCT02541994|Device|Pachette3|Central corneal thickness will be measured with an ultrasound probe. This test will be performed while the corneas are anesthetized. This test will be performed as part of a standard, comprehensive dilated eye examination with optical coherence tomography and visual field testing as the regular care for benign intracranial hypertension.
16047683|NCT02541994|Device|Lenstar-Think|Axial length will be measured with an ultrasound probe. This test will be performed while the corneas are anesthetized. This test will be performed as part of a standard, comprehensive dilated eye examination with optical coherence tomography and visual field testing as the regular care for benign intracranial hypertension.
16047684|NCT02541968|Behavioral|Cognitive-behavioral therapy (face-to-face)|
16047685|NCT02541968|Behavioral|Internet-based Cognitive-behavioral therapy|With therapist support
16047686|NCT02541968|Behavioral|Internet-based Cognitive-behavioral therapy without therapist support|
16047687|NCT02541955|Drug|Acthar|Injections will be self administered
16047688|NCT02541942|Other|No treatment given|For patient convenience, genetic material will be collected in the form of saliva samples.
16047689|NCT02541929|Dietary Supplement|Docosahexaenoic acid|
16047690|NCT02541916|Other|Controlled weaning of immunosuppression|At week 0 patients have liver biopsy and liver functional tests (LFTs). Week 1-4 medication reduction to 1.5mg Tacrolimus (Tac) daily or 150mg Cyclosporine A (CsA). At week 4 LFTs. Week 5-8 medication reduction to 1mg Tac / 100mg CsA. Week 8 LFTs. Week 9-12 reduction to 0.5mg Tac/ 50mg CsA. Week 12 LFTs. Week 13-16 reduction to 0mg. Week 16 liver biopsy & LFTs. Weekly LFTs performed Week 17-20. Monthly LFTs for the next 3 months. LFTs every 3 months for monitoring.
16047691|NCT02541903|Drug|Gilotrif|Patients will take a single oral dose of Gilotrif each day starting at 40 mg. Dose escalation and reductions can occur.
16047692|NCT02541890|Behavioral|Work place intervention|Meeting at the work place including the patient, the employer and the rehabilitation therapist. Aim of meeting is to discuss challenges and possibilities in the patient's return to work process and to make a plan for return to work.
16047693|NCT02541877|Device|Down sizing valve in type-0 BAS|Subjects will undergo percutaneous retrograde trans-peripheral arterial aortic valve implantation with the self-expandable bio-prosthesis. Before implantation a balloon dilatation of the aortic annulus and a simultaneous aortic root angiography will be performed. Down sizing valve implantation will be used in type-0 BAS.
16047694|NCT02541877|Device|Standard sizing valve in type-0 BAS|Subjects will undergo percutaneous retrograde trans-peripheral arterial aortic valve implantation with the self-expandable bio-prosthesis. Before implantation a balloon dilatation of the aortic annulus and a simultaneous aortic root angiography will be performed. Standard sizing valve implantation will be used in type-0 BAS.
16047695|NCT02541877|Device|Standard sizing valve in TAS|Subjects will undergo percutaneous retrograde trans-peripheral arterial aortic valve implantation with the self-expandable bio-prosthesis. Before implantation a balloon dilatation of the aortic annulus and a simultaneous aortic root angiography will be performed. Standard sizing valve implantation will be used in TAS.
16047696|NCT02541864|Drug|Bismuth quadruple therapy|pantoprazole 40 mg bid for 14 days, bismuth subcitrate 120 mg qid for 14 days, tetracycline 500 mg qid for 14 days, metronidazole 250 mg qid for 14 days
16047697|NCT02541864|Drug|Hybrid therapy|(pantoprazole 40 mg bid for 7 days, amoxicillin 1 g bid for 7 days) followed by (pantoprazole 40 mg bid for 7 days, amoxicillin 1 g bid for 7 days, clarithromycin 500 mg bid for 7 days, and metronidazole 500 mg bid for 7 days)
16047698|NCT02541838|Other|Muscle power|
16047699|NCT02541838|Other|balance perturbation|
16047700|NCT02541838|Other|aerobic exercise|
16047701|NCT02541825|Device|the stent of diameter of 7mm|108 patients use the stent of diameter of 7mm in TIPS
16047702|NCT02541825|Device|the stent of diameter of 8mm|108 patients use the stent of diameter of 8mm in TIPS
16047703|NCT02541812|Device|Transcranial Magnetic Stimulation|A non-invasive method for brain stimulation
16047704|NCT02541799|Procedure|Audio-visual telemedicine|Participants in an emergency department will have their care delivered using telemedicine, then they will be approached for a study by a study investigator using the same telemedicine link
16047705|NCT02541799|Procedure|Standard care|Participants in an emergency department will have their care delivered in person, then they will be approached by a study investigator face-to-face.
16047834|NCT02540655|Procedure|Excipients|Patients will receive excipients through intravenous infusion
16047706|NCT02541786|Drug|dexlansoprazole based triple therapy|dexlansoprazole MR 60 mg once daily+clarithromycin 500 mg twice daily+ amoxicillin 1 g twice daily for 7 days
16047707|NCT02541786|Drug|rabeprazole-based triple therapy|rabeprazole 20 mg twice daily + clarithromycin 500 mg twice daily + amoxicillin 1 g twice daily for 7 days
16047708|NCT02541773|Device|Cardiac Resynchronisation Therapy|Routine implantation of CRT - part of standard of care
16047709|NCT02541760|Drug|Monteleukast|4 ml monteleukast daily for one month
16047710|NCT02541760|Drug|Mometasone|Inhaled mometasone 1 puff in each side of nose for one month
16047711|NCT02541747|Behavioral|massage|massage
16047712|NCT02541734|Drug|Gelofusine|Infusion of gelofusine
16047713|NCT02541734|Radiation|111In-exendin 4 SPECT/CT|111In-exendin 4 SPECT/CT
16047714|NCT02541734|Drug|Placebo|
16047715|NCT02541721|Device|LabiaStick#01|"This medical device has emollient agents whose main function is to increase the skin hydration, provide physical protection and decrease the symptoms and possibility of recurrence of vulvar dermatoses.
~The medical device should be applied once daily, in the evening, after a gentle washing (plain water with no cleansing products), on the affected non-hairy vulvar area."
16047716|NCT02541708|Drug|Ferric carboxymaltose|Intravenous Ferric carboxymaltose given at a calculated dose of 20mg/kg body weight in 1-3 infusions according to severity of anemia
16047717|NCT02541708|Drug|Ferrous sulfate + folic acid|Three dried ferrous sulfate and folic acid tablets every morning 30 mins before the meal. If side effects occur the drug may be taken with the meal or in 2 separate doses per day. The treatment will be pursued for 3 months after correction of anemia
16047718|NCT02541695|Biological|E. coli strain E1392-75-2A|"At study day 14, after a standardized evening meal and an overnight fast, subjects will receive a single oral dose of the attenuated diarrhoeagenic E. coli strain E1392-75-2A (dose will be either 1E10 CFU (n=22) or 5E10 CFU (n=22)). Oral challenge will occur at 10.00 AM. Under supervision of the project team, subjects will get a NaHCO3 solution (100 ml 2% NaHCO3) to neutralize the gastric acid. After 5 minutes, they get a fruit juice (100 ml) containing the attenuated diarrhoeagenic E. coli strain at the above-mentioned dose. Subjects go home, but are not allowed to drink or eat for 1 hour.
~At study day 35, after a standardized evening meal and an overnight fast, all subjects will receive a second inoculation 1E10 CFU of the diarrhoeagenic E. coli."
16047719|NCT02541682|Other|TEMPS-A (Temperament Evaluation of Memphis, Pisa, Paris and San Diego Auto-questionnaire)|Participants filled out the TEMPS-A survey at their first visit.
16047720|NCT02541669|Drug|TAK-491|TAK-491 tablets
16047721|NCT02541669|Drug|TAK-491 placebo|TAK-491 placebo-matching tablets
16047722|NCT02541656|Procedure|Study of preload dependence indices after volume expansion in laparoscopy with Saldinger technique.|The measurements of pulse pressure variation, plethysmographic waveform of pulse oximetry variation and stroke volume variation will be performed before pneumoperitoneum at the beginning of the surgery, and will be repeated after pneumoperitoneum insufflation applying each time modification of preload conditions (applying reverse Trendelenburg position followed by Trendelenburg position). The responses will be appreciated by the measurements of the stroke volume.
16047723|NCT02541643|Drug|Elotuzumab|"Elotuzumab will be administered intravenously at a dose of 10mg/kg weekly (Days 1, 8, 15, and 22 of a 4-233k cycle) of the first 2 cycles and every 2 weeks (Day 1 and Day 15) thereafter.
~A window of -1 to +3 days is permitted in Cycles 1 and 2. In Cycle 1 and 2, an elotuzumab dose that falls outside of the pre-specified window must be skipped. In Cycles 3 and beyond, elotuzumab dosing may be delayed for up to 1 week as clinically indicated. If unable to administer within 1 week, then the dose should be skipped and resumption of the elotuzumab continues per the guidance document defined schedule. In addition the following premedication must also be administered 30-90 minutes prior to any elotuzumab:
~H1 blocker: diphenhydramine (25-50mg PO or IV) or equivalent
~H2 blocker: ranitidine (50mg IV) or equivalent
~acetaminophen (650-1000mg PO)"
16047724|NCT02541630|Behavioral|Big Mind|mindfulness based intervention
16047725|NCT02541617|Procedure|Programming by community Neurologist|Deep Brain stimulator with be programmed by a community Neurologist
16047726|NCT02541617|Procedure|Standard of care|Deep Brain Stimulator will be programmed with at the implanting movement disorders center
16047727|NCT02541604|Drug|Atezolizumab|Atezolizumab was administered as IV infusion (maximum 1200 mg) on Day 1 of each 21-day cycle.
16047728|NCT02541591|Other|Neuroprotective goal directed hemodynamic optimization|
16047729|NCT02541591|Other|MAP > 65mmHg|MAP > 65mmHg
16047730|NCT02541565|Drug|Cyclophosphamide|Given IV
16047731|NCT02541565|Drug|Doxorubicin Hydrochloride|Given IV
16047732|NCT02541565|Other|Laboratory Biomarker Analysis|Correlative studies
16047733|NCT02541565|Biological|Pembrolizumab|Given IV
16047734|NCT02541565|Drug|Prednisone|Given PO
16047735|NCT02541565|Biological|Rituximab|Given IV
16047736|NCT02541565|Drug|Vincristine Sulfate|Given IV
16047737|NCT02541552|Drug|Ropivacaine 0.5%|Varying volume according to motor response of previous subject
16047738|NCT02541539|Dietary Supplement|Lactobacillus casei Zhang|This project aims to study the benefits of probiotics namely Lactobacillus casei Zhang in prevention of upper respiratory and gastrointestinal illnesses, among adults in Malaysia aged from 18-81 years.
16047739|NCT02541539|Dietary Supplement|Placebo|This project aims to study the benefits of probiotics namely Lactobacillus casei Zhang in prevention of upper respiratory and gastrointestinal illnesses, among adults in Malaysia aged from 18-81 years.
16047740|NCT02541526|Drug|Mirtazapine|One capsule (15 mg) oral mirtazepine daily will be started on day six of treatment for a period of 3 days followed by two capsules (30 mg) daily for a period of four months
16047741|NCT02541526|Drug|Placebo|Similar capsule containing placebo will be started on day six of treatment for a period of 3 days followed by two capsules of placebo daily for a period of four months
16047742|NCT02541513|Drug|paliparidone|All patients will begin receiving oral paliperidone 3 mg daily for three days, beginning on Day 5 of the inpatient phase. All patients will receive an injection of Paliperidone 150 mg injection on Day 8 of the inpatient phase. Patients will receive monthly 150 mg injection for the next 3 months.
16047743|NCT02541500|Drug|Minocycline|Oral minocycline 200 mg daily will be started on day six of treatment for a period of four months
16047835|NCT02540642|Dietary Supplement|METHYLCOBALAMIN 500 micrograms|Tab Methycobalamin 500 ug will be given with other regular antidiabetic drugs
16047744|NCT02541487|Dietary Supplement|Alli-nutritional supplement|Obese participants in the FIT-PLESE clinical trial randomized to the nutritional restriction /AlliTM/physical activity arm that achieve pregnancy.
16047745|NCT02541474|Other|Integrated care|The PACT model facilitates better care by : 1) a structured person centered needs assessment , 2) individual care plans , and 3) and an inter- professional team that coordinates services across specialties and levels of care.
16047746|NCT02541461|Procedure|Laparoscopic gastrectomy|(1) Wedge resection, subtotal or total gastrectomy with or without lymph node dissection; (2) R0 resection; (3) Laparoscopic gastrectomy; (4) Gastroduodenal anastomosis or duodenal bypass, including Roux-en-Y or gastrojejunostomy
16047747|NCT02541448|Device|SurgiQuest AIRSEAL® Insufflation System (AIS)|"The SurgiQuest AirSeal Optical Trocar & Cannula System with integrated Insufflator DPIS 2000 (the DPIS 2000 System) is intended for use in diagnostic and/or therapeutic endoscopic procedures to distend the peritoneal cavity by filling it with gas (establish and maintain pneumoperitoneum), to establish and maintain a path of entry for endoscopic instruments, and to evacuate surgical smoke. The trocar of the DPIS 2000 System is indicated for use with or without visualization."
16047748|NCT02541422|Dietary Supplement|N Acetyl Cysteine|
16047749|NCT02541422|Other|placebo|
16047750|NCT02541409|Drug|Sofosbuvir|Direct acting antiviral agent used for the treatment of hepatitis C
16047751|NCT02541409|Drug|Pegylated Interferon alfa-2a|Antiviral agent used for the treatment of hepatitis C
16047752|NCT02541409|Drug|Ribavirin|Antiviral agent (guanosine analogue) used for the treatment of hepatitis C
16047753|NCT02541396|Drug|Wafermine|35 or 70 mg ketamine in a sublingual wafer
16047754|NCT02541396|Drug|Oxycodone|5 mg oxycodone capsule
16047755|NCT02541396|Drug|Placebo|Placebo capsule or placebo wafer
16047756|NCT02541383|Drug|Bortezomib (VELCADE), Thalidomide, and Dexamethasone (VTD)|Part 1: 4 Cycles of Bortezomib,Thalidomide and Dexamethasone induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone consolidation
16047757|NCT02541383|Drug|Bortezomib, Thalidomide, Dexamethasone (VTD) + daratumumab|Part 1: 4 Cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16mg/kg induction therapy, followed by Autologous Stem Cell Transplantation, followed by 2 cycles of Bortezomib, Thalidomide and Dexamethasone plus daratumumab 16 mg/kg consolidation
16047758|NCT02541383|Drug|Daratumumab|Daratumumab 16mg/kg every 8 weeks for 2 years
16047759|NCT02541370|Biological|anti-CD133-CAR vector-transduced T cells|genetically engineered lymphocyte therapy
16047760|NCT02541357|Behavioral|relaxation program|"relaxation and mindfulness techniques such as body scan, breathing meditation or imagination exercises
~1 week program, one introductory session and daily home practice"
16047761|NCT02541357|Behavioral|surgery education|"intensified education unit to reduce anxiety and stress, by using pictures and videos of rooms, and procedures of the planned surgery
~1 single unit in the week before the surgery"
16047762|NCT02541344|Device|Dose 1 of IQP-VV-102|Dose 1 (D1) group will take 2 tablets with active ingredients and 2 placebo tablets.
16047763|NCT02541344|Device|Dose 2 of IQP-VV-102|Dose 2 (D2) group will take 4 tablets with active ingredients.
16047764|NCT02541344|Device|Placebo|"Placebo group will take 4 placebo tablets.
~The placebo is designed to be identical to IQP-VV-102."
16047765|NCT02541331|Biological|ISMIGEN|Tablets of 30 billion organisms/mg - Sublingual use 1 tablet per day over 10 days for 3 successive months.
16047766|NCT02541331|Biological|PLACEBO|Matched tablets without any active substance.
16047767|NCT02541318|Behavioral|Duo-in exercise|Duo-in exercise was originated from China and with a 5000-years history. Ancient people adopted Duo-in to treat and prevent diseases.
16047768|NCT02541305|Other|propioceptive program|The training program has 6 specific proprioceptive exercises, each five minutes long, which will conducted in static and dynamic positions for a period of 30 minutes. Each exercise session will include 55 minutes (15 minutes of warm-up with slow walk, mobility and stretching exercise, followed by 30 minutes of a propioceptive exercises program, and finishing with 10 minutes of cool down through stretching and relaxation exercises)
16047769|NCT02541305|Other|No propioceptive program|The control group continued to perform their daily activities without changing any habit. Geriatric revitalization program without proprioceptive exercises.
16047770|NCT02541292|Other|No intervention, observational|
16047771|NCT02541279|Procedure|Physiotherapy exercises guideline|Exercises controlled by a physiotherapist.
16047772|NCT02541266|Other|Questionnaire|A short questionnaire (9 questions) will be given to the participants to complete.
16047773|NCT02541253|Biological|GC3110A|A single 0.5mL dose intramuscular injection
16047774|NCT02541253|Biological|GCFLU Pre-filled Syringe inj.|A single 0.5mL dose intramuscular injection
16047775|NCT02541240|Other|Resilience Curriculum|The Resilience Curriculum consists of 4 modules, with one 2-hour module presented each week.
16047776|NCT02541227|Drug|Cerebrolysin|Cerebrolysin dosage, frequency and duration follows local clinical practice in accordance with the terms of the local marketing authorization
16047777|NCT02541214|Device|Trial Nasal Mask|
16047778|NCT02541201|Dietary Supplement|Plant sterols-enriched low-fat milk|The study product is a dried partly skimmed milk powder with no more than 12% milk fat (11.4g total fat/100g product) containing unesterified, unhydrogenated plant sterols.
16047779|NCT02541201|Dietary Supplement|Low-fat milk|The placebo product is a dried partly skimmed milk powder.
16047780|NCT02541188|Genetic|Genetic analysis|
16047781|NCT02541162|Behavioral|Oral information and interviews|interviews about sexuality and self experience during the disease
16047782|NCT02541149|Procedure|blood sample|
16047783|NCT02541136|Behavioral|Aerobic Exercise|"Each exercise class consisted of a warm-up, an aerobic and a cool-down phase, supervised by a physiotherapist. The warm up and cool down phases consisted of 5-7 minutes of low intensity aerobic exercise, < 40% Heart Rate Reserve (HHR), to allow the cardiopulmonary and musculoskeletal systems to adapt and recover, respectively.
~The aerobic component initially consisted of 21 minutes at an intensity of 40-59% HRR and was progressed to 42 minutes at 55-75% HRR by week 8 until programme completion. All participants worked at the same intensity and duration at the various time points throughout the study. Continuous, rhythmic exercise using large muscle groups was prescribed using treadmills, cycle ergometers and other aerobic exercise that increased heart rate to its prescribed level."
16047784|NCT02541123|Other|Blood draw|Initial draw followed by additional blood draws every 4 hours thereafter, up to 24 hours from the initial blood draw (not to exceed 7 blood draws). Follow up blood draw at Day 7. Control group only undergoes 2 blood draws 4 hours apart on Day 1.
16047785|NCT02541097|Behavioral|Language therapy|Participants will receive semantic and phonological therapy for words they cannot retrieve spontaneously. They will be given an opportunity to practice the words in a group setting.
16047786|NCT02541084|Drug|Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)|Anti-VEGF therapy following the Summary of Product Characteristics
16047787|NCT02541071|Behavioral|Stress Film|
16047788|NCT02541071|Drug|Yohimbine|
16047789|NCT02541071|Drug|Clonidine|
16047790|NCT02541071|Drug|placebo|
16047791|NCT02541045|Drug|metadoxine|metadoxine 500mg tablets: 1 Tablet by mouth twice in day during 6 months
16047792|NCT02541045|Other|placebo|placebo tablets: 1 Tablet by mouth twice in day during 6 months
16047793|NCT02541032|Procedure|Intensive dental treatment|Up to five sessions of full-mouth removal of subgingival dental plaque by the use of scaling and root planning under local anesthesia. Any hopeless teeth will be extracted during this treatment period, which will be as short as possible, but will extend to no more than 4 weeks. In addition to standard scaling and root planning, the investigators seek to better suppress the oral biofilm by administering Arestin locally into the periodontal pockets ≥6 mm.
16047794|NCT02541032|Procedure|Standard dental treatment|Supragingival mechanical scaling and polishing.
16047795|NCT02541032|Drug|Arestin|To better suppress the oral biofilm by administering Arestin locally into the periodontal pockets ≥6 mm.
16047796|NCT02541019|Drug|Ondansetron|4 mg IV, one minute before the anesthesia induction and 4 mg IV three times a day during two days after the surgery.
16047797|NCT02541019|Drug|Palonosetron|75 mcg IV, one minute before the anesthesia induction.
16047798|NCT02541006|Drug|Tiotropium 18 mcg|tiotropium 18 mcg once a day
16047799|NCT02540993|Drug|Finerenone (BAY94-8862)|Oral tablet; starting dose at 10 mg for subjects with an eGFR between 25 to < 60 mL/min/1.73m² at the Screening Visit; starting dose at 20 mg for subjects with an eGFR ≥ 60 mL/min/1.73m² at the Screening Visit; dose could be up-titrated from Month 1 onwards or down-titrated at any time during the study; once daily in the morning, until the trial was completed provided there were no safety grounds for discontinuing treatment
16047800|NCT02540993|Drug|Placebo|Matching placebo, oral tablet, once daily in the morning, until the trial was completed provided there were no safety grounds for discontinuing treatment
16047801|NCT02540967|Drug|Gadobutrol (Gadavist/Gadovist, BAY86-4875)|Gadovist dosage following summary of product characteristics
16047802|NCT02540954|Drug|Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)|A dose of 2 mg aflibercept injected intravitreally
16047803|NCT02540941|Other|non|
16047804|NCT02540928|Drug|AMG 319 hydrate|
16047805|NCT02540928|Drug|Placebo|
16047806|NCT02540915|Other|Standard of Care - Registry|Standard of Care - Registry
16047807|NCT02540902|Device|All-polyethylene tibia (Aesculap AG)|Implantation of an all polyethylene tibial component.
16047808|NCT02540889|Behavioral|Auditory comprehension therapy.|100 hours of Auditory comprehension therapy embedded within a computer game.
16047809|NCT02540876|Drug|Ilorasertib|Given PO
16047810|NCT02540876|Other|Laboratory Biomarker Analysis|Correlative studies
16047811|NCT02540863|Other|myofascial release protocol and Rocabado exercise therapy|
16047812|NCT02540863|Other|exercise therapy|
16047813|NCT02540837|Drug|Bupivacaine|Obturator nerve block
16047814|NCT02540837|Drug|Saline|Obturator nerve block with saline(placebo)
16047815|NCT02540824|Drug|Apatinib single agent arm|For RET-fusion positive advanced NSCLC patients who failed to previous treatment,treat with apatinib, single agent, 750mg once daily, p.o until disease progression
16047816|NCT02540811|Device|dCELL® ACL Scaffold|
16047817|NCT02540785|Procedure|lenticule extraction|Four femtosecond incisions were created in succession: the posterior surface of the refractive lenticule (spiral in), the lenticule border, the anterior surface of the refractive lenticule (spiral out), and the corneal flap in the superior region. After the suction was released, the flap was opened using a thin, blunt spatula and the free refractive lenticule was subsequently grasped with a forceps and extracted, after which the flap was repositioned carefully
16047818|NCT02540785|Procedure|small-incision lenticule extraction|Four femtosecond incisions were created in succession: the posterior surface of the refractive lenticule (spiral in), the lenticule border, the anterior surface of the refractive lenticule (spiral out), make a small incision
16047819|NCT02540772|Behavioral|Neuropsychological treatment|Participants had to learn some brief material (words, faces, pictures, news), after which they were asked for an immediate and a delayed recall. After both recalls, participants were confronted with feedback about correct responses, non-responses and errors (i.e., confabulations and errors of attribution). This type of feedback worked on: 1) selective attention during the learning phase, training patients to focus on the relevant details of the stimuli; 2) monitoring processes during the retrieval phase, reinforcing the strategic search and training patients to inhibit traces that were irrelevant; and 3) memory control processes after the retrieval phase. The treatment consisted of 9 sessions and lasted for 3 weeks and the participants performed a baseline before and after treatment.
16047820|NCT02540759|Dietary Supplement|Buglossoides oil|
16047821|NCT02540759|Dietary Supplement|High Oleic Sunflower Oil|
16047822|NCT02540746|Behavioral|ERG Skills Training|Group-based Dialectical Behavior Therapy Skills Training for 12 weeks
16047823|NCT02540746|Behavioral|Motivational Enhancement|Three week Motivational Enhancement group
16047824|NCT02540746|Behavioral|Family Skills Training|12-week group-based family skills training using Family Connections model
16047825|NCT02540720|Drug|Dexamethasone|
16047826|NCT02540720|Drug|Gamma globulin|
16047827|NCT02540720|Procedure|Hemoperfusion|
16047828|NCT02540707|Drug|solifenacin|solifenacin 5 mg per day for 12 weeks
16047829|NCT02540707|Drug|mirabegron|mirabegron 25 mg per day for 12 weeks
16047830|NCT02540694|Device|Endosonography|
16047831|NCT02540668|Drug|Lanabecestat|Administered orally
16047832|NCT02540668|Drug|Warfarin|Administered orally
16047833|NCT02540655|Biological|Stemchymal®|Patients will receive Stemchymal® through intravenous infusion
16047836|NCT02540629|Procedure|Bundled EMS CPR approach including dispatcher-assisted CPR, 3-person team CPR, and feedback CPR monitoring device|Gold standard EMS CPR refers to our bundled approach to providing high quality EMS CPR through one or more intervention(s) as applicable including 1) dispatcher-assisted CPR, 2) multi-tiered team CPR, and 3) feedback CPR.
16047838|NCT02540603|Device|F&P Jupiter Full Face Mask|Investigative F&P Jupiter full face mask to be used for OSA therapy
16047839|NCT02540590|Device|laser speckle contrast imaging of the oral mucosa|Non-invasive method to measure tissue blood perfusion applied for oral mucosa
16047840|NCT02540590|Device|wound fluid measurement|Wound fluid at the gingival sulcus was volumetrically measured by Periotron 8000 instrument using filter strip
16047841|NCT02540551|Procedure|Injection of radioactive tracer combined with Patent Blue|Blue dye and the radioactive isotope will be injected in the remains of the ligamentum ovarium proprium (median side) and the ligamentum infundibulo-pelvicum (lateral side), just below the peritoneum. Four syringes containing 0,2 ml patent blue and 0,15 ml (20-MBq) radioactive isotope (99mTc-nanocolloid or Nanocoll®, GE Healthcare, Eindhoven, The Netherlands) will be given. After a 15-minute interval the radioactivity the SN(s) will be identified either by the mobile gamma-camera and /or gamma-probe and / or visually (blue dye) after opening the retroperitoneal space.
16047842|NCT02540538|Biological|HBVaxPro|3 vaccinations with HBVaxPro-10ug at 0, 30, and 180 days.
16047843|NCT02540538|Biological|HBAI20|2 vaccinations with HBAI20 at 0 and 30 days and 1 vaccination with HBVaxPro-10ug at 180 days.
16047844|NCT02540525|Device|Ophira|The procedure will be perfomed with a single incision in anterior wall vagina
16047845|NCT02540525|Device|Transobturator sling|Safyre T Plus ® system uses two helical needles for securing an average urethral sling mesh polypropylene soft tissue below the pubic bone by means of spinal anesthesia. Short form of the sling implantation is carried out as follows: a small longitudinal incision in the anterior vaginal wall approximately 2 cm is performed at 1 cm from the urethral meatus. Takes place below minimum dissection toward the lower branch of the ischium, and with the aid of the needle obturator and perforated membrane (outside-in maneuver). After that, the sling is attached to the needle carrying the same path. Subsequently, the passage of the needle is held in contraleral side. The procedure finishes performing the adjustment of the track with the aid of Kelly forceps type.
16047846|NCT02540512|Procedure|Auricular Acupuncture|Aiguille Semi-Permanent (ASP) acupuncture needles will be used following the Battlefield Acupuncture Protocol
16047847|NCT02540512|Device|Acupuncture|ASP Needles: Small, semi-permanent acupuncture needles that will be used for acupuncture in the ear or taped over the ear for placebo.
16047848|NCT02540512|Procedure|Placebo Acupuncture|The ASP needles will be double taped onto the ear for this procedure.
16047849|NCT02540512|Drug|hydrocodone / acetaminophen 5mg/325mg|"Narcotic/NSAID medication used as the standard medical treatment"
16047850|NCT02540512|Drug|Placebo Pill|Pills will be filled with methylcellulose and administered as a placebo for this intervention.
16047851|NCT02540499|Radiation|DIBH VMAT|Radiotherapy delivered in deep inspiration breath-hold with volumetric modulated arc therapy technique.
16047852|NCT02540486|Other|Long-acting insulin glargine titration web tool (LTHome)|The LTHome study arm will receive insulin glargine titration instructions from the LTHome web-based tool
16047853|NCT02540486|Other|Diabetes Education|Individual diabetes education, detailed instructions on the use of the blood glucose monitor and unlimited availability of blood glucose monitoring supplies.
16047854|NCT02540473|Behavioral|Manualized Therapy|Relational psychotherapy mothers
16047855|NCT02540473|Behavioral|Control Group|one hour of free time to do with as they wish
16047856|NCT02540460|Drug|LCB01-0371 800mg|LCB01-0371 800mg
16047857|NCT02540460|Drug|LCB01-0371 800mg BID|LCB01-0371 800mg BID
16047858|NCT02540460|Drug|LCB01-0371 1200mg BID|LCB01-0371 1200mg BID
16047859|NCT02540460|Drug|Placebo|Placebo
16047860|NCT02540447|Procedure|Purge|In the recipient before portal declamping, the graft preservative solution and the mesenteric blood is washed out of the circulation into the abdominal cavity and sucked by external sucker through the incompletely anastomosed hepatic vein prior to portal declamping
16047861|NCT02540434|Device|ROTEM|ROTEM delta will be used to identify intraoperative coagulation abnormalities. A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve.
16047862|NCT02540434|Other|Cryoprecipitate|Subjects with hypofibrinogenemia who are randomized to the Cryoprecipitate arm will be transfused with Cryoprecipitate
16047863|NCT02540434|Drug|RiaSTAP|Subjects with hypofibrinogenemia who are randomized to the RiaSTAP arm will be transfused with concentrated fibrinogen
16047864|NCT02540395|Drug|Tacrolimus (for Group B)|Tacrolimus (for Group B) will be administered orally twice a day (bid). Tacrolimus (for Group B) will be initially given at the 0,1mg/kg bid to achieve a stable 12-hour trough level of 8-10 ng/mL during the first month after transplantation to progressively tapper to 6-8ng/ml thereafter.
16047865|NCT02540395|Drug|MMF (mycophenolate mofetil) (for Group B)|"MMF (mycophenolate mofetil) will be administered orally to patients in group B at conventional doses (1gr/12h) before transplant procedure and during the first 7 days after transplant. For subjects who develop nausea, diarrhea, or other MMF(mycophenolate mofetil) -related gastrointestinal adverse effects (eg, symptoms fully assessed and deemed not to have an etiology other than intolerability to MMF), the MMF(mycophenolate mofetil) dose may be decreased to the maximally tolerated dose.
~Subjects unable to tolerate the reduced dose may be converted to mycophenolate sodium (Myfortic™) or to Myfenax.
~From day 8 on, patients will not receive MMF."
16047975|NCT02539641|Radiation|Gastric emptying scintigraphy|Scintigraphy is performed to evaluate gastric emptying after eating a pancake labeled by 20 megabecquerel (MBq) Technetium-99m-Albumin (TC-99m-LyoMAA)
16049044|NCT02532036|Biological|Intramuscular MVA85A|
16047866|NCT02540395|Drug|6-methyl prednisolone (Steroids) (for Group B)|"At the time of surgery, all patients will receive 500mg of 6-methyl prednisolone (Steroids, Urbason, Methypred).
~Patients in group B will receive 250mg of 6-methyl prednisolone (or equivalent) on day 2, 125 mg on day 3, 60 mg on day 4 and 30 mg on day 5. From day 6 on, patients will receive 0.25 mg/kg/d of 6-methyl-prednisolone (Steroids, Urbason, Methypred) until month 1, then tapering until discontinuation on month 2 will be performed."
16047867|NCT02540395|Drug|Tacrolimus (for Group A)|"The study group A will receive Tacrolimus (for Group A) (Prograf) to achieve 4-8 ng/ml trough levels during all the duration of the study.
~Tacrolimus (for Group A) (Tacrolimus) capsules should generally be administered on an empty stomach or at least 1 hour before or 2 to 3 hours after a meal, to achieve maximal absorption."
16047868|NCT02540395|Drug|Mycofenolate mofetil (MMF) (for Group A)|"Mycophenolate mofetil (MMF) (Cellcept, Myfortic, Myfenax) (for Group A) will be administered orally to patients in group A at conventional doses (1gr/12h). For subjects who develop nausea, diarrhea, or other Mycophenolate mofetil (MMF) (for Group A) -related gastrointestinal adverse effects (eg, symptoms fully assessed and deemed not to have an etiology other than intolerability to Mycophenolate mofetil (MMF) (for Group A), the Mycophenolate mofetil (MMF) (for Group A) dose may be decreased to the maximally tolerated dose.
~Subjects unable to tolerate the reduced dose may be converted to mycophenolate sodium (Myfortic™).
~The first dose of Mycophenolate mofetil (MMF) (for Group A) should be administered before transplantation."
16047869|NCT02540395|Drug|6-methyl prednisolone (Steroids) (for Group A)|"At the time of surgery, all patients will receive 500 mg of 6-methyl prednisolone (steroids for Group A).
~Patients in arm A will receive 20 mg/day of 6-methyl prednisolone (steroids for Group A) (or the equivalent) during the first 2 weeks after transplantation, then tapering to 15 mg from week 3 to week 4 to finally be maintained at 5mg/day."
16047870|NCT02540382|Device|covered stent|A broad range of implant diameters and lengths for the treatment of in-stent restenotic peripheral and central lesions* in patients with AV grafts and AV fistulae Small incremental stent graft lengths to help maintain venous real estate and cannulation area Minimal shortening and radiopaque markers aid in excellent placement accuracy
16047871|NCT02540382|Device|bare stent|"A one piece laser cut, self-expanding nitinol stent combining a micromesh design with a multi segmental construction.
~The 36 strut, 6 bridge construction of the Stent provides an unmatched balance of radial force, scaffolding, and longitudinal stability.
~The design offers crush recoverable flexibility in the most challenging vasculature, with optimal wall apposition, conformability and minimal foreshortening.
~It offers a broad portfolio of sizes for the treatment of routine and challenging Iliofemoral lesions."
16047872|NCT02540369|Drug|Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)|Administration by intravitreal injection.Muti-target Anti-VEGF agent. Dosing would be at physicians discretion.
16047873|NCT02540356|Biological|BAX69 Single-Route Arm|Intraperitoneal (IP) only
16047874|NCT02540356|Biological|BAX69 Double-Route Arm|Intravenous (IV) infusion + intraperitoneal (IP) infusion
16047875|NCT02540343|Other|questionnaires|fill out all questionnaires twice
16047876|NCT02540330|Drug|Fulvestrant|
16047877|NCT02540317|Behavioral|Internet-based CBT|Internet-based treatment with therapist support using an asynchronous messaging system. The treatment is comprised of 12 modules (similar to chapters) and the treatment is 12 weeks long. The treatment is based on cognitive behavior therapy
16047878|NCT02540304|Behavioral|Reducing the Risk|Safer Sex is a clinic-based intervention intended to reduce the incidence of STIs and increase condom use among high-risk sexually active female adolescents and delivered in face-to-face individualized sessions by a female health educator. Reducing the Risk is a sexuality-education curriculum, most often delivered in a school setting that provides instruction and practice in the social skills needed to put into action what students learn about preventing pregnancy and reducing unsafe behavior in future high-risk situations. ¡Cuidate! is adapted from the Be Proud! Be Responsible! curriculum and culturally tailored for Latino youth. It aims to reduce HIV risk and unintended pregnancies by affecting sexual behaviors such as intercourse, number of partners, and condom use.
16047879|NCT02540291|Drug|E7046|E7046 will be administered as a single agent orally once daily (QD) continuously in 21-day cycles. In the dose escalation part, increasing doses of E7046 ranging from 125 mg to 750 mg will be administered to cohorts of 6 participants. In the cohort expansion part, participants will be treated at the RP2D.
16047880|NCT02540278|Behavioral|Positive Prevention PLUS|PP+ has elven 45 minute lessons: (1) Getting Started, (2) Life Planning, (3) Healthy Relationships, (4) Relationship Violence, (5) Family Planning and Contraceptives, (6) Myths and Stereotypes, (7) HIV Disease and AIDS, (8) Recognizing and Reducing Risk, (9) Peer and Media Pressures, (10) Human Immunodeficiency Virus (HIV)/Sexually Transmitted Disease (STD) Testing and Community Resources, and (11) Steps to Success.
16047881|NCT02540265|Drug|N1539|
16047882|NCT02540265|Drug|Intravenous Placebo|
16047883|NCT02540252|Other|Nutritional status among patients with lower limb amputation|Patients nutritional status, inflammatory and metabolic pathway are observed during their hospitalization.
16047884|NCT02540239|Drug|2L PEG|
16047885|NCT02540239|Drug|2L PEG+simethicone|
16047886|NCT02540226|Drug|Intravenous tranexamic acid|
16047887|NCT02540226|Drug|Topical tranexamic acid|
16047888|NCT02540226|Drug|Intravenous saline|
16047889|NCT02540226|Drug|Topical saline|
16047890|NCT02540213|Device|MIRCERA|Methoxy polyethylene glycol epoetin beta (0.6 mcg/kg q2w) will be administered using MIRCERA ready-to-use-syringes up to 9 months.
16047891|NCT02540200|Device|BST-CarGel|BST-CarGel is a scaffolding material after microfracture treatment is performed in order to treat the chondral lesions. It assists in the repair process by stabilizing the clot in the cartilage lesion via adhesion and inhibition of clot retraction.
16047892|NCT02540200|Procedure|Microfracture|It is a bone marrow stimulation technique, and the standard treatment for chondral lesions of the hip joint.
16047893|NCT02540187|Other|blood specimen|
16047926|NCT02540018|Device|Transluminal Angioplasty with Paclitaxel-coated Luminor® Balloon Catheter in the Superficial Femoral and Popliteal Arteries|"Endoluminal guidewire passage of the stenotic and occlusive femoro-popliteal lesion must be performed. A pre-dilatation follows. Then the investigational procedure (DEB) is assigned by randomization.
~Luminor35®-DEB PTA catheter is applied."
16047976|NCT02539641|Other|Determination of gut hormones|Gut hormone levels will be determined after eating a standard meal in the RYGB and SG groups.
16047894|NCT02540174|Procedure|integrated addiction treatment program|"At the inclusion, a 45 min interview for : the completion of questionnaires (Fagerström, AUDIT, CAST, Socrates, M.I.N.I), the collection of socio-professional information, obstacles and incentives to stop the consumption of alcohol and tobacco, the record of alcohol-tobacco consumptions, the measurement of exhaled carbone monoxide rate expressed in particles per million using the CO tester.
~At 3, 6, and 12 months : a 20 min interview to assess the alcohol-tobacco consumption and the obstacles and incentives to stop the consumption.
~The first addiction consultation will be carried out directly in the cancer treatment unit and integrated to the overall cancer treatment program."
16047895|NCT02540174|Procedure|standard of care|"The following actions will be performed by a nurse or by the study coordinator on site who have been trained in tobaccology and addictology :
~At the inclusion, a 45 minutes interview for : the completion of questionnaires (Fagerström, AUDIT, CAST, Socrates, M.I.N.I) , the collection of socio-professional information, obstacles and incentives to stop the consumption of alcohol and tobacco, the record of alcohol-tobacco consumptions, the measurement of exhaled carbone monoxide rate expressed in particles per million (ppm) using the CO tester.
~At 3, 6, and 12 months: a 20 minutes interview to assess the alcohol-tobacco consumption and the obstacles and incentives to stop the consumption"
16047896|NCT02540161|Drug|Sym004 - 18 mg/kg|Sym004 was dosed at 18 mg/kg intravenously every two weeks.
16047897|NCT02540161|Drug|Sym004 - 24 mg/kg|Beginning in August 2017, the dose was increased to 24 mg/kg intravenously every two weeks.
16047898|NCT02540148|Device|Nova Oculus™ Micro-current electrical stimulation|Active treatment with transpalpebral micro-current electrical stimulation device, 3 sessions within 5 days of the 1st treatment. 1 session during weeks 2, 14 and 26.
16047899|NCT02540148|Device|Nova Oculus™ Micro-current electrical stimulation - Sham treatment|Non-active treatment with transpalpebral micro-current electrical stimulation SHAM device, 3 sessions within 5 days of the 1st treatment. 1 session during weeks 2, 14 and 26.
16047900|NCT02540135|Other|fluorescein|fluorescein and conventional neuro-navigation
16047901|NCT02540135|Other|intraoperative MRI|conventional neuro-navigation and iMRI
16047902|NCT02540122|Device|Marketed Contact Lens 1|Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).
16047903|NCT02540122|Device|Marketed Contact Lens 2|Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).
16047904|NCT02540122|Device|Marketed Contact Lens 3|Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).
16047905|NCT02540122|Device|Marketed Contact Lens 4|Marketed contact lens being worn by the subject in a bilateral fashion for approximately 6 hours (+/- 30 minutes).
16047906|NCT02540109|Device|HD-tDCS (Soterix Medical, Active)|Subject will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets.
16047907|NCT02540109|Device|HD-tDCS (Soterix Medical, Sham)|Subject will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets.
16047908|NCT02540096|Other|Mental practice|"The sessions will be individualized and carried out in a peaceful setting.The aim of the mental practice protocol was to promote motor imagery of the following activities: get up from a chair and walk and sit, which enrolls the basic and instrumental activities of daily living. The sessions will consist of six steps: (1) Physical Practice (2) Familiarization (3) Memory (4) Relaxation (5) Repeat and (6) post-practice mental relaxation. After the mental practice session, participants will be submitted to individual and structured physiotherapy sessions (the same as the control groups)."
16047909|NCT02540096|Other|Cognitive training and Relaxation|Cognitive training and relaxation session (lasting 30 minutes, three times a week), totaling 12 sessions. The sessions will consist of calculations, memorization, imagination and body relaxation exercises. These sessions will not have any motor imagery. After the cognitive training and relaxation session, participants will be submitted to individual and structured physiotherapy sessions lasting 40 minutes with muscle strengthening and stretching exercises.
16047910|NCT02540083|Device|DBT and FFDM|Subjects underwent FFDM breast imaging followed by DBT breast imaging
16047911|NCT02540070|Procedure|Periarticular|
16047912|NCT02540070|Procedure|Motor free|
16047913|NCT02540070|Procedure|Motor free with dex|
16047914|NCT02540070|Drug|Ropivacaine|
16047915|NCT02540070|Drug|epinephrine|
16047916|NCT02540070|Drug|morphine|
16047917|NCT02540070|Drug|Ketorolac|
16047918|NCT02540070|Drug|Dexmedetomidine|
16047919|NCT02540070|Drug|saline|
16047920|NCT02540057|Procedure|Flexor carpi radialis|Ligament reconstruction with tendon interposition completed using the flexor carpi radialis tendon
16047921|NCT02540057|Procedure|Abductor pollicis longus|Ligament reconstruction with tendon interposition completed using the abductor pollicis longus tendon
16047922|NCT02540044|Behavioral|ANSWER-2 decision aid|ANSWER-2 will consist of: 1) an Information Module that presents effectiveness and side effects of each treatment option, and 2) an interactive Value Clarification Module that guides patients to consider what matter to them the most, and the pros and cons of each treatment option. Within the Information Module, the decision support information (i.e., the benefits and harms of treatment options) will be presented in narrated text, graphics, and a series of animated patient stories demonstrating attributes required for effective communication with doctors and significant others.
16047923|NCT02540044|Behavioral|Control Group (TAS Consumer Guide)|The Arthritis Society Consumer guide pdf.
16047924|NCT02540031|Drug|"Additional oral preparation (3L of PEG+Asc, Coolprep®)"|"The interventional or experimental arm will receive 1l of additional PEG+Asc, Coolprep® on the day of colonoscopy
~* Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g"
16047925|NCT02540031|Drug|"Standard oral preparation (2L of PEG+Asc, Coolprep®)"|"The control arm will receive currently used oral preparation (2l of PEG+Asc, Coolprep®) for colonoscopy
~* Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g"
16047973|NCT02539654|Drug|EXE844 Sterile Otic Suspension, 0.3%|
16047974|NCT02539654|Procedure|Tympanostomy Tube Insertion|
16048175|NCT02538367|Drug|YH12852 IR 0.3mg|
16048176|NCT02538367|Drug|YH12852 IR 0.5mg|
16047927|NCT02540018|Device|Transluminal Angioplasty with and non-coated (CE-marked) plain old angioplasty balloon (POBA) catheter|Endoluminal guidewire passage of the stenotic and occlusive femoro-popliteal lesion must be performed. A pre-dilatation follows. Then the investigational procedure is assigned by randomization. POBA catheter is applied.
16047928|NCT02540005|Other|ROTEM analysis|
16047929|NCT02539992|Device|Triathlon® CR/Kinematic Alignment|Total knee replacement using patient-specific cutting guides
16047930|NCT02539992|Device|Triathlon® CR/Neutral Overall Limb Alignment|Total knee replacement using patient-specific cutting guides
16047931|NCT02539992|Device|Triathlon® CR/Conventional Limb Alignment|Total knee replacement using traditional instrumentation
16047932|NCT02539979|Drug|Paracetamol|
16047933|NCT02539979|Drug|Placebo - Normal Saline|Normal Saline 100cc
16047934|NCT02539966|Device|Fantom Sirolimus-Eluting Coronary Bioresorbable Scaffold|Bioresorbable Drug-Eluting Scaffold Implantation for the Treatment of Coronary Artery Disease
16047935|NCT02539953|Device|Ambulatory blood pressure monitoring|Patients with dizziness on taking rivaroxaban will have ambulatory blood pressure monitoring to assess haemodynamic effects indirectly
16047936|NCT02539940|Device|Angioplasty Paclitaxel-eluted balloon catheter ELUTAX SV|Angioplasty for revascularization in below-the-knee arteries
16047937|NCT02539914|Other|Virtual Reality|Virtual reality based upper-limb motor and cognitive task
16047938|NCT02539914|Other|Standard|Standard upper-limb motor and cognitive rehabilitation tasks
16047939|NCT02539901|Behavioral|Evaluation of the detection of non-linguistic sounds|Evaluation of the detection of non-linguistic sounds (sound room)
16047940|NCT02539901|Behavioral|Free hearing test categorization|Free hearing test categorization evaluation
16047941|NCT02539901|Behavioral|Early Social Communication Scale (ECSP)|Early Social Communication Scale (ECSP) evaluation
16047942|NCT02539901|Behavioral|psychomotor infancy development scale|
16047943|NCT02539901|Behavioral|"NEPSY (two domains: memory and learning and attention and executive functions)."|NEPSY evaluation
16047944|NCT02539875|Behavioral|AWARD and brief leaflet/ Referral leaflet and active referral/ Smoking cessation booklet and general advices|Use AWARD and brief leaflet/ Referral leaflet and active referral/ Smoking cessation booklet and general advices interventions to achieve smoking abstinence
16047945|NCT02539862|Other|cognitive behavioral therapy online|The cognitive behavioral therapy online program is delivered through an accessible web application on a web browser with a personal password
16047946|NCT02539862|Other|psychoeducation|the psychoeducation is delivered by a doctor
16047947|NCT02539849|Dietary Supplement|FOS|
16047948|NCT02539849|Drug|Adalimumab|
16047949|NCT02539836|Dietary Supplement|Dietary nutrition based on plant fermentation extract|The main ingredient of dietary nutrition is plant fermentation extraction which is from many fruit and vegetable fermented by probiotics.
16047950|NCT02539836|Diagnostic Test|MRI in quantifying liver fat with MRS|To investigate the accuracy of MRI in quantifying liver fat with magnetic resonance spectroscopy (MRS) as a reference.
16047951|NCT02539823|Drug|CBD 400 mg|Subjects in Arm CBD 400 mg will receive 400mg of Cannabidiol in each of the three test sessions
16047952|NCT02539823|Drug|CBD 800 mg|Subjects in Arm CBD 800 mg will receive 800mg of Cannabidiol in each of the three test sessions
16047953|NCT02539823|Drug|Control (placebo)|Subjects will receive a harmless, inactive solution to compare and validate the results of the other arms of the study
16047954|NCT02539810|Device|Renal artery Angioplasty plus stenting.|renal artery stenting
16047955|NCT02539810|Drug|Anti hypertensive, statin and antiplatelet medication.|Slow release indapamide 1.5 mg/d (or furosemide 40 mg/d if eGFR is < 30 mL/min/1.73m²) + irbesartan 300 mg/d + amlodipine 10 mg/d + aspirin 75 mg/d (or clopidogrel 75 mg/d in case of allergy or gastrointestinal intolerance to aspirin) + atorvastatin 20 mg/d. After randomization, bisoprolol 10 mg/d, prazosin 5 mg/d, and rilmenidine 1 mg/d and spironolactone 12.5 to 25 mg/d, will be sequentially added from months two to five in both groups if home blood pressure remains more than or equal to 135/85 mm Hg.
16047956|NCT02539797|Device|tDCS|comparing anodal, cathodal, and sham tDCS
16047957|NCT02539784|Device|"Kit for Spinal Cord Stimulator System  SCS Systems  : PRECISION® System"|3 frequencies of SCS are tested for each patient : 50, 100 and 130 Hz
16047958|NCT02539771|Other|Polysomnography and blood sample|"Blood collection is a specific intervention of protocol for the 3 arms. Polysomnography is a specific intervention for the arms  Diurnal VOC  and  Slightly symptomatic "
16047959|NCT02539758|Other|ocular massage|ocular massage could be applied over the globe over the closed eyelids with moderate massage strength for 15 minutes. The compression of the globe was given with finger, and press for 2 seconds, then by a 2 seconds release, with a frequency of 15 presses/minute.
16047960|NCT02539758|Device|LenstarLS900|observed changes of anterior chamber depth before and after ocular massage by LenstarLS900
16047961|NCT02539758|Device|Goldmann tonometer|observed changes of intraocular pressure before and after ocular massage by Goldmann tonometer
16047962|NCT02539745|Other|Vitamin D receptor polymorphic analysis|Vitamin D receptor polymorphic analysis was studied by real-time polymerase-chain reaction high resolution melting analysis.
16047963|NCT02539745|Other|Serum levels of 1a, 25-Dihydroxyvitamin D3|Serum levels of 1a, 25-Dihydroxyvitamin D3 were measured by enzyme-linked immunoabsorbent assay.
16047964|NCT02539719|Drug|SC-003|
16047965|NCT02539719|Drug|SC-003 in combination with ABBV-181|
16047966|NCT02539706|Drug|Rocuronium 0,6mg/kg|patients at days 8 to 14 of the menstrual cycle were considered to be at the follicular phase and Rocuronium 0,6mg/kg intravenous was applied
16047967|NCT02539706|Drug|Rocuronium 0,6mg/kg|patients at days 18 to 24 of the menstrual cycle were considered to be at the luteal phase and Rocuronium 0,6mg/kg intravenous rocuronium was applied
16047968|NCT02539693|Drug|Clonidine 75 µg/mL in sacrococcygeal block|Sacrococcygeal block will be performed using 75 µg/mL clonidine in the anesthetic mixture
16047969|NCT02539693|Drug|Clonidine 150 µg/mL in sacrococcygeal block|Sacrococcygeal block will be performed using 150 µg/mL clonidine in the anesthetic mixture
16047970|NCT02539693|Drug|Lidocaine|3 ml lidocaine 1% is injected at each block site
16047971|NCT02539693|Procedure|Pilonidal sinus|Removal of pilonidal sinus
16047972|NCT02539680|Procedure|endoscopy|duodenal biopsies
16048177|NCT02538367|Drug|YH12852 IR 1mg|
16047977|NCT02539628|Drug|ropivacaine 0.2%|Adductor canal block. Placed immediately postoperative. Intervention stops on POD2 12PM
16047978|NCT02539615|Device|ForeCYTE Breast Aspirator|
16047979|NCT02539602|Behavioral|The Need to Know students received the N2K curriculum as described previously|
16047980|NCT02539589|Behavioral|BART|BART is an out of school educational program that intends to provide cognitive behavioral training to reduce HIV risk. It is intended to be implemented in 8 sessions lasting 1.5-2 hours. Sessions are to be implemented by a male and female health educator in small gender specific groups of 5-15 participants.
16047981|NCT02539589|Behavioral|Healthy Living|Healthy Living is a knowledge-based intervention that intends to provide one HIV information-only session and seven sessions on nutrition, healthy eating, body image, and exercise. It is intended to be implemented in 8 sessions lasting 1.5-2 hours. Sessions are to be implemented by a male and female health educator in small gender specific groups of 5-15 participants.
16047982|NCT02539576|Drug|ABC/DTG/3TC FDC tablet|"ABC/DTG/3TC FDC will be supplied as purple, biconvex, oval tablets debossed with 572 Trı on one side and plain on the other side. A single dose, with a unit dose strength of 600 mg/50 mg/300 mg will be administered orally."
16047983|NCT02539563|Other|peanut shaped birthing ball|peanut ball will be utilized
16047984|NCT02539550|Drug|Placebo|Placebo
16047985|NCT02539550|Drug|PF-06266047|PF-06266047
16047986|NCT02539537|Drug|Gemcitabine|
16047987|NCT02539537|Drug|Folinic Acid|
16047988|NCT02539537|Drug|5-Fluoro-uracil|
16047989|NCT02539537|Drug|Oxaliplatin|
16047990|NCT02539537|Drug|Irinotecan|
16047991|NCT02539537|Drug|L-folinic|
16047992|NCT02539524|Other|Yoga bhastrika pranayama breathing exercise|Bhastrika Pranayama is formed by a set of 20 nasal forced and rapid expirations, followed by passive nasal inspirations, followed by 1 alternate nasal breath which always begins through the right nostril, and has a retention between intake and outflow. The set of this breathing exercise is supposed to bring respiratory relief.
16047993|NCT02539524|Other|Pulmonary Rehabilitation|Pulmonary Rehabilitation Group Intervention consisted of 12-week pulmonary rehabilitation. Two 1 hour sessions a week, consisting of: 30 min of aerobic training followed by resistance exercises for upper and lower limbs.
16047994|NCT02539511|Drug|CI-581a|
16047995|NCT02539511|Drug|CI-581b|
16047996|NCT02539511|Behavioral|Motivational Enhancement Therapy (MET)|
16047997|NCT02539498|Device|HR-pQCT|HR-pQCT to evaluate cortical and trabecular bone
16047998|NCT02539485|Other|heating precondition|The streamlined liner of the pharynx airway (SLIPA) was heated 2 hours before use.
16047999|NCT02539472|Other|Blood sampling|Blood sampling for quantitative evaluation of nine candidate biomarkers (CD158k/KIR3DL2, KIR2DL4, KIR2DS1, KIR2DS3, KIR3DL1, NKp46, PLS3/T-Plastin, Twist and TOX) by quantitative RT-PCR.
16048000|NCT02539459|Drug|Everolimus|10 mg tablets
16048001|NCT02539446|Behavioral|stable condition|
16048002|NCT02539446|Behavioral|unstable condition|
16048003|NCT02539446|Behavioral|attentional focus|
16048004|NCT02539433|Procedure|F-18-F-DOPA|F-18-F-DOPA i.v. injection of a dose of up to 8.5 mCi. PET scanning started 60-90 minutes post injection
16048005|NCT02539420|Device|BiPAP treatment|Patients will receive BiPAP (via Respironics V60 or Vision BIPAP device) as part of their treatment for status asthmaticus
16048006|NCT02539407|Other|Pharmacokinetics|
16048007|NCT02539394|Drug|Methylprednisolone Acetate|Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.
16048008|NCT02539394|Other|Hemostatic Matrix Kit|Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.
16048009|NCT02539381|Procedure|Formal Perimetry (Goldman or Octopus visual Field)|
16048010|NCT02539381|Procedure|Albert's visual inattention test|
16048011|NCT02539381|Procedure|Star cancellation visual inattention test|
16048012|NCT02539381|Procedure|Visual field assessment to confrontation|
16048013|NCT02539381|Procedure|Visual inattention assessment to bilateral stimuli|
16048014|NCT02539381|Device|Digital tumbling E visual accuity assessment|
16048015|NCT02539381|Device|Digital visual field assessment|
16048016|NCT02539381|Device|Digital line crossing assessment|
16048017|NCT02539381|Device|Digital shape cancellation assessment|
16048018|NCT02539368|Drug|CT-P13|biosimilar infliximab
16048019|NCT02539368|Drug|Remicade|infliximab
16048020|NCT02539355|Other|Diet A|12-week diet
16048021|NCT02539355|Other|Diet B|12-week Diet
16048022|NCT02539342|Drug|Caphosol|"Subjects randomized to the Caphosol Arm will use Caphosol 4 times per day as follows:
~Each dose consists of two 15 mL syringes, to be mixed at time of administration. Caphosol must be used within 15 minutes of mixing.
~o Participants may increase the use to 6 times per day if you have symptoms of mucositis.
~Using one of the syringes, rinse and gargle (if patient is able) for one minute and then spit. Repeat using the remaining syringe.
~For younger patients (less than or equal to 6 years of age), volume may be reduced to two syringes containing 5-10 mL each.
~For patients unable to successfully rinse and spit, caregivers may paint their mouth (using medical sponge swabs) with the solution two times. Repeat using the second syringe.
~Patients are to avoid other oral medications, other mouth cares and food or drink for 15 minutes after using Caphosol.
~Patients may use Biotene (5-10 mL) to swish and spit after the 15 minutes has passed"
16048023|NCT02539342|Drug|Biotene|"• Use 5 to 10 mL of Biotene to swish and spit
~o For patients unable to successfully rinse and spit, caregivers may paint their mouth (using medical sponge swabs) with the solution two times. Prior to swabbing the patient's mouth, pour Biotene into a cup and using the medical sponge, soak up the solution and use the swab to coat the inside of the patient's mouth. Repeat with a second swab."
16048024|NCT02539329|Other|Neurological assessment and Blood sample|Neurological assessment (physical examination, electroneuromyography , International Prognostic Score (ISS), Overall Disability Scale (ODS), Rankin score) and 2 blood collection tubes for antibody screening
16048025|NCT02539316|Drug|Smoflipid|
16048026|NCT02539316|Drug|Médialipides|
16048027|NCT02539303|Drug|Yamani-15/5 chemical solution|A 20 ml of Yamani-15/5 will be directly infused into the diseased (calcific) arterial distribution.
16048028|NCT02539290|Behavioral|Detection of ovulation|Detecting the luteinizing hormone surge using test sticks in a urine sample
16048029|NCT02539290|Procedure|Uterine flushing|Injection of 20 millilitres of physiological saline by an intra-uterine catheter the day of the luteinizing hormone surge
16048030|NCT02539290|Procedure|Vaginal flushing|Injection of 10 millilitres of physiological saline intravaginally the day of the luteinizing hormone surge
16048031|NCT02539290|Behavioral|Sexual intercourse|Sexual intercourse within 12 hours after intervention
16048032|NCT02539277|Drug|Jinyebaidu granule|It is a chinese patent medicine extracted from four herbs: honeysuckle, isatis leaf, dandelion, and houttuynia cordata thunb.
16048033|NCT02539277|Drug|Fufangshuanghua granule|It is a Chinese patent medicne extracted from four herbs: honeysuckle, forsythia, radix Isatidis, andrographis paniculata.
16048034|NCT02539277|Drug|Jinyebaidu granule placebo|It is Jinyebaidu granule placebo.
16048035|NCT02539277|Drug|Fufangshuanghua granule placebo|It is Fufangshuanghua granule placebo.
16048036|NCT02539264|Other|Smoking|Influence of smoking on parameters derived from overnight PSG
16048037|NCT02539264|Other|Obesity|Influence of obesity on parameters derived from overnight PSG
16048038|NCT02539264|Other|Benzodiazepine use|Influence of benzodiazepine use on parameters derived from overnight PSG
16048039|NCT02539251|Behavioral|Arabic ASQ -3|Administration of a developmental questionnaire in Arabic (A-ASQ-3) and validation using BSID-III as a gold standard
16048040|NCT02539238|Other|Longitudinal practice and real-time feedback|Brief CPR practice distributed during working hours with real-time feedback
16048041|NCT02539225|Drug|Ramucirumab|Administered IV
16048042|NCT02539225|Drug|Placebo|Administered IV
16048043|NCT02539225|Drug|S-1|Administered PO
16048044|NCT02539225|Drug|Oxaliplatin|Administered IV
16048045|NCT02539225|Drug|Paclitaxel|Administered IV
16048046|NCT02539212|Device|microwave ablation|ultrasound-guided microwave ablation is performed to treat hepatocellular carcinoma patients
16048047|NCT02539212|Device|radiofrequency ablation|ultrasound-guided radiofrequency ablation is performed to treat hepatocellular carcinoma patients
16048048|NCT02539199|Drug|Misoprostol, modified-release pessary|Misoprostol pessary (7 ug/h) placed in vaginal fornix until labour is induced or maximum 24 hours
16048049|NCT02539199|Drug|Misoprostol, per-oral tablets|First day: 50 ug PO in every 4 hours maximum 3 times per day. Second day: 100 ug PO in every 4 hours maximum 3 times per day. Third day: 50 ug vaginally in every 4 hours maximum 3 times per day or until labour is induced.
16048050|NCT02539186|Biological|platelet rich plasma|Sono-guided injection with 3cc platelet rich plasma between carpal tunnel and median nerve
16048051|NCT02539186|Device|splint|
16048052|NCT02539173|Other|Ultrasound scan|"Non-invasive and non-irradiating. The diaphragmatic thickening in recovery is measured before and after the completion of the anesthetic block using the ultrasound system, the ultrasound probe and of an aqueous gel by trans-thoracic approach.
~It measures the thickness on deep inspiration and expiration in supine position. Each measurement is repeated twice. This measurement series lasts 4 minutes, is repeated 15 minutes after completion of the engine block when a block is found and contralateral. The total measurement time is about 12 minutes."
16048053|NCT02539160|Drug|ticagrelor|Diabetic patients with or without chronic kidney disease will be randomized 1:1 to either (A) standard dose (90mg twice daily of ticagrelor) for 7-10 days and then cross-over to low dose (60mg twice daily of ticagrelor) for 7-10 days; (B) low dose (60mg twice daily of ticagrelor) for 7-10 days (phase 1) and then cross-over to standard dose (90mg twice daily of ticagrelor) for 7-10 days (phase 2).
16048054|NCT02539147|Biological|blood samples|Isolation and stimulation of monocytes, preparation of cell lysates, measurement of cytokine production, Western blot
16048055|NCT02539134|Drug|TAK-935|TAK-935 oral solution
16048056|NCT02539134|Drug|Placebo|TAK-935 placebo-matching oral solution
16048057|NCT02539121|Device|Acupuncture|Acupuncture needles
16048058|NCT02539108|Biological|Fluzone® Quadrivalent Influenza Vaccine, No Preservative|0.25 mL, Intramuscular (Pediatric Dose, 2015 2016 formulation)
16048059|NCT02539108|Biological|Fluzone® Quadrivalent Influenza Vaccine, No Preservative|0.5 mL, Intramuscular (2015 2016 formulation)
16048060|NCT02539095|Device|CartiZol|The product, CartiZol, which contains absorbable collagen, is applied on the cartilage defect to stimulate the neovasculization and cell penetration and to assist the natural wound healing process. It supplements the defective or damaged cartilage. Place the needle on the tip of the syringe and inject the product into the articular cavity.
16048061|NCT02539095|Device|Normal saline|"Supplementation of fluid and electrolytes (sodium or chlorine deficiency)
~Diluent for injection solution Place the needle on the tip of the syringe and inject the product into the articular cavity."
16048062|NCT02539082|Device|Regenseal|Regenseal, collagen, injection in the defect area
16048063|NCT02539082|Drug|normal saline|placebo, normal saline, injection in the defect area
16048064|NCT02539069|Device|Chondron Implantation|In one vial (0.4 ml), Main ingredient: 1.2 million or more autologous chondrocytes Culture solution: Adequate amount of Dulbecco's modified Eagle medium (DMEM) The cells that fill the vial are sufficiently suspended, and a sufficient amount of suspension is grafted in the defect with fibrin glue.
16048065|NCT02539056|Device|Chondron Implantation|In one vial (0.4 ml), Main ingredient: 1.2 million or more autologous chondrocytes Culture solution: Adequate amount of Dulbecco's modified Eagle medium (DMEM) The cells that fill the vial are sufficiently suspended, and a sufficient amount of suspension is grafted in the defect with fibrin glue.
16048066|NCT02539043|Device|LIPOFOCUS|In cavitation focused ultrasound procedure for reduction of localized abdominal fat, the parameters will be used: maximum power of 8 Watts at a frequency of 1 Megahertz (MHz), and the transducer is used in a timely manner by performing a sweep of the area by 03 times, at random.
16048067|NCT02539043|Device|LIPOFOCUS|In cavitation focused ultrasound procedure for reduction of localized abdominal fat, the parameters will be used: maximum power of 8 Watts at a frequency of 1 MHz, and the transducer is used in a timely manner by performing a sweep of the area by 03 times, at random . The procedure is followed by stereodynamic drainage, where it will be used a printhead comprising three ERAs (effective radiation area) of 15 Watt each time this procedure is calculated through the area (size of the area to be treated) divided by ERA (cm² head size).
16048068|NCT02539030|Procedure|Microfracture|simple microfracture
16048069|NCT02539030|Device|CartiFill|add collagen when doing microfracture
16048178|NCT02538367|Drug|YH12852 IR 2mg|
16048070|NCT02539017|Drug|Chemo|Epirubicin,75mg/m2,intravenous ,on day 1 of each 21 day cycle, 4 cycles Cyclophosphamide,0.6g/m2,intravenous, on day 1 of each 21 day cycle, 4 cycles Docetaxel,75mg/m2, intravenous, on day 1 of each 21 day cycle, 4 cycles
16048071|NCT02539017|Biological|Immunotherapy|Immunotherapy with double dendritic cell (DC)and cytokine-induced killer (CIK) cell
16048072|NCT02539004|Other|Ultrasound study|Ultrasound study using real-time image fusion with a previous NCCT
16048073|NCT02538991|Device|Bulkamid|"Urethral injections will be performed policlinically under local anesthesia (10 ml lidocain, two injections on both sides of the urethra). The Bulkamid-injections will be transurethral four injections (0.2 - 1ml) in locations ten, two and five and seven o'clock within 0.5 to 1 cm from the bladder - urethra junction.
~Additional injections will be avoided and can be injected only if the first injections fail. After the operation the patient urinates to empty the bladder. The PVR is checked after the treatment with ultrasound simultaneously with evaluation of stability of the Bulkamid-injections. The treatment will be photographed as before and after still pictures for later evaluation."
16048074|NCT02538991|Device|Tension-free Vaginal Tape|TVT will be performed under local anesthesia (70 - 100 ml 0.25% prilocain cum epinephrine) with i.v. pain medication phentanyl two doses and more on request. Operation will be performed with TVT-Exact® kit. Operation can be performed policlinically or in an operation theatre depending on the patient's medical condition. Cystoscopy will be performed after the set of tapes. A cough stress test with 250 to 300 ml bladder fulfillment will show the right tension of the tape. Before the operation a prophylactic antibiotic of Cefuroxime 1.5 g i.v will be given (Dalacin 900 mg i.v in cases of allergy to penicillin). The patient can go home after 2 to 4 hours follow-up, when PVR is under 150 ml. A sick leave of 5 days is recommended.
16048075|NCT02538978|Biological|Autologous Bone Marrow Concentrate (aBMC)|"Aspirated bone marrow will be processed by centrifugation, separating out a concentrate (aBMC) comprising primarily white blood cells and platelets. These cells will be injected i.m. to loci determined by the operating physician using imaging and vascular flow criteria.
~Device: SurgWerks-CLI Kit
~Device: VXP System"
16048076|NCT02538978|Biological|Placebo Control (diluted autologous peripheral blood)|Diluted peripheral blood prepared in a blinded fashion to resemble bone marrow will be injected intramuscularly per the same procedure used for the Experimental Device Arm.
16048077|NCT02538965|Drug|Lenalidomide|Lenalidomide will be administered orally once daily for the first 21 days of every 28-day cycle. The starting dose will be 2 mg/kg/day with a maximum dose of 70 mg/day. Number of cycles: 12, or until evidence of progressive disease. Participants will also be discontinued if unresolved toxicities as described in the protocol occur, or if dose reductions are required and subject does not tolerate minimum dose level of 1mg/kg/day.
16048078|NCT02538952|Device|Xpert device|"Interventions in the Experimental phase of this stepped-wedge trial include: (a) ensuring WHO-recommended TB screening adopted, (b) situating trained TB case finding nurses in the clinics, (c) training clinic personnel in the TB diagnostic algorithms, and (d) activation of the Xpert diagnostic device."
16048079|NCT02538952|Other|Intensified TB Case Finding (ICF)|Interventions in the active comparator phase of this stepped wedge trial only include: (a) adoption of the WHO-recommended 4-symptom TB screen for adults; (b) situating trained TB case-finding nurses in the 22 facilities; and (c) training health facility personnel in TB diagnostic algorithms. There is no Xpert device activation in this phase. Only the standard of care microscopy algorithm (smear microscopy and chest x-ray) are available during this phase.
16048080|NCT02538939|Drug|Sodium thiosulfate|
16048081|NCT02538926|Drug|Asparaginase|Given IM or IV
16048082|NCT02538926|Drug|Cyclophosphamide|Given IV
16048083|NCT02538926|Drug|Doxorubicin Hydrochloride|Given IV
16048084|NCT02538926|Drug|Etoposide|Given IV
16048085|NCT02538926|Drug|Imatinib Mesylate|Given PO
16048086|NCT02538926|Other|Laboratory Biomarker Analysis|Correlative studies
16048087|NCT02538926|Drug|Prednisone|Given PO
16048088|NCT02538926|Biological|Rituximab|Given IV
16048089|NCT02538926|Drug|Vincristine Sulfate|Given IV
16048090|NCT02538913|Behavioral|Exercise training|Daily pelvic floor muscle training and individualized regular exercise training (aerobic and strength exercise) three days per week.
16048091|NCT02538913|Procedure|Usual care|Patients randomized to the control group will receive standard care which does not include any pelvic floor muscle training or individualized exercise training
16048092|NCT02538900|Behavioral|Exercise|Participants in one of the exercise intervention groups will attend once weekly sessions at the medical center for the first four weeks of the study (Weeks 1-4, Phase I). During weeks 5-52 (Phase II), they will receive weekly telephone calls from a study coach.
16048093|NCT02538900|Other|Attention control|Our attention control group controls for the possibility that regular contact with the study team may improve outcomes in participants randomized to the intervention. Participants randomized to the control group will attend weekly one-hour educational sessions at Northwestern University for the first four weeks of the intervention (Phase I). These sessions are on topics of interest to the typical PAD patient and are led by physicians and other health care workers. Topics include Medicare Part D, nutritional supplements, and cancer screening. During Phase II (weeks 5-52), the attention control group will receive weekly telephone calls, lasting 5-15 minutes, with information on a health-related topic.
16048094|NCT02538887|Device|Radio Frequency Surgical Detection|
16048095|NCT02538874|Drug|BMS-986171|
16048096|NCT02538874|Other|Placebo|
16048097|NCT02538861|Radiation|SPECT Imaging Test at Baptist hospital|Single Photon Emission Tomography (SPECT) testing at Baptist Hospital.
16048098|NCT02538861|Radiation|CT Angiography and CT myocardial perfusion at West Kendall Baptist Hospital|The combined approach of CT Angiography and CT myocardial perfusion with new Revolution CT scanner
16048099|NCT02538861|Radiation|SPECT Imaging Test at West Kendall Baptist Hospital|Single Photon Emission Tomography (SPECT) testing at West Kendall Baptist hospital.
16048100|NCT02538848|Drug|HTD4010|injectable solution
16048101|NCT02538835|Behavioral|Metacognitive therapy|Group format, 10-12 participants in each group. 8 weekly sessions of two hours each.
16048102|NCT02538835|Behavioral|Mindfulness based cognitive therapy, group|Group format, 10-12 participants in each group. 8 weekly sessions of two hours each following the manual described by Williams, Zindel & Segal.
16048179|NCT02538367|Drug|YH12852 IR 3mg|
16048180|NCT02538367|Drug|YH12852 DR1 0.5mg|
16048181|NCT02538367|Drug|YH12852 DR1 1mg|
16048103|NCT02538835|Behavioral|Support groups|Group format, 10-12 participants in each group. The sessions will only be of supportive character and will not focus on changing or restructuring thoughts, scripts or thought patterns. The format will follow a manual but compared to the other intervention groups the format allow participants to suggests themes for discussions.
16048104|NCT02538822|Device|dynamic imaging|In vivo study of biomechanical behavior of ATA from preoperative dynamic imaging : dynamic CT-scan and 4D-magnetic resonance imaging (MRI)
16048105|NCT02538822|Device|mechanical testing|In vitro study of with mechanical inflation testing of ATA tissue harvested during surgery.
16048106|NCT02538809|Other|measurement of tumor mRNA concentration in urine|bed-side test of tumor mRNA concentration in urine
16048107|NCT02538796|Other|TEA + Grober Test + Task 1 + Grober Test|"The Test of Everyday Attention (TEA) measures the reaction time of the participant during the occurrence of an expected stimulus.
~The Grober Test with 16 words to learn and to remember, measures the episodic verbal memory long term.
~The Task 1 consists of a stimulus that moves on the screen. The response of the patient is done on the keyboard. It is composed on two conditions: one is fast (without conscious), the other consists in assessing words (conscious). It includes food and non-food words."
16048108|NCT02538796|Other|TEA + Grober Test + Task 2 + Grober Test|"The TEA measures the reaction time of the participant during the occurrence of an expected stimulus.
~The Grober Test with 16 words to learn and to remember, measures the episodic verbal memory long term.
~The Task 2 consists of a stimulus that is fixed on the screen. The response of the patient is done by pushing or pulling a lever. It is composed on two conditions: one is fast (without conscious), the other consists in assessing words (conscious). It includes food and non-food words."
16048109|NCT02538796|Other|TEA + Grober Test + Implicit Task 3 + Grober Test|"The TEA measures the reaction time of the participant during the occurrence of an expected stimulus.
~The Grober Test with 16 words to learn and to remember, measures the episodic verbal memory long term.
~The Task 3 is a compilation of tasks 1 and 2 to investigate the bidirectional link. The instructions are implicit condition to detect an A in the word (yes-no answer)."
16048110|NCT02538796|Other|TEA + Grober Test + Explicit Task 3 + Grober Test|"The TEA measures the reaction time of the participant during the occurrence of an expected stimulus.
~The Grober Test with 16 words to learn and to remember, measures the episodic verbal memory long term.
~The Task 3 is a compilation of tasks 1 and 2 to investigate the bidirectional link. The instructions are explicit condition to judge the emotional value of words (positive-negative answer)."
16048111|NCT02538783|Behavioral|Escalating Lottery|Participants in the lottery arms will receive financial incentives as part of the intervention. See arm descriptions for more detail.
16048112|NCT02538770|Other|Rapid diagnostics using Anyplex TMII RV16 Detection|Rapid diagnostics using Anyplex TMII RV16 Detection, i.e. physician receives results of respiratory virus PCR as soon as they are available
16048113|NCT02538770|Other|Delayed diagnostics Anyplex TMII RV16 Detection|Delayed diagnostics Anyplex TMII RV16 Detection, i.e. physician receives results of respiratory virus PCR after one week delay unless specifically solicited
16048114|NCT02538744|Drug|Doxazosin|Participants will be randomized into two groups: placebo and doxazosin 8 mg/d. The doxazosin dose will be increased every 4 days over 11 days, starting with 1mg on the first study day and and ending with 8mg 11 days later. Participants will receive one capsule daily that will contain either placebo or doxazosin.
16048115|NCT02538744|Drug|Modafinil|After titrating doxazosin to the target dose, study procedures will be completed three times, once during treatment with each dose of modafinil (0 [placebo], 200, and 300 mg/d), in pseudo-random order such that 200 mg precedes 300 mg).
16048116|NCT02538744|Drug|cocaine|On the 5th day of study medication treatment participants will receive non-contingent doses of cocaine (placebo, 20, 40 mg, IV) and participate in cocaine self-administration sessions.
16048117|NCT02538744|Drug|Placebo|
16048118|NCT02538731|Procedure|dilation-assisted stone extraction|
16048119|NCT02538731|Device|Spyglass Guided Laser Lithotrips|
16048120|NCT02538718|Drug|MgSO4|
16048121|NCT02538718|Drug|YTP(Ritodrine)|
16048122|NCT02538705|Drug|Neovasculgen|
16048123|NCT02538692|Drug|Tong-Xie-Yao-Fang|Tong-Xie-Yao-Fang is a traditional Chinese formula. It is used for diarrhea management.
16048124|NCT02538692|Drug|Placebo|The placebo is the same as Tong-Xie-Yao-Fang in appearance.
16048125|NCT02538679|Other|Placebo|The usual intraoperative and postoperative pain control; NO TAP block performed
16048126|NCT02538679|Drug|US TAP Bupivacaine/Epinephrine|Ultrasound guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.
16048127|NCT02538679|Drug|Lap TAP Bupivacaine/Epinephrine|Laparoscopic guided bupivacaine 0.25% with epinephrine 1:400k will be injected to the transversus abdominis plane.
16048128|NCT02538666|Biological|Nivolumab|
16048129|NCT02538666|Biological|Ipilimumab|
16048130|NCT02538666|Other|Placebo|
16048131|NCT02538653|Other|Sandwich biscuit high in SDS|Consumption of the high SDS product (50g) alone with a glass of water
16048132|NCT02538653|Other|Co-extruded cereal low in SDS|Consumption of the low SDS product (48.3 g) alone with a glass of water
16048133|NCT02538640|Other|High-SDS biscuit|Consumption of the high-SDS product (50g) alone with a glass of water
16048134|NCT02538640|Other|Low-SDS extruded cereals|Consumption of the low-SDS product (42g) alone with a glass of water
16048135|NCT02538627|Drug|MM-151|MM-151
16048136|NCT02538627|Drug|MM-121|MM-121
16048137|NCT02538627|Drug|MM-141|MM-141
16048138|NCT02538627|Drug|trametinib|trametininb
16048139|NCT02538614|Drug|Idelalisib|Tablets administered orally twice daily
16048140|NCT02538614|Drug|BI 836826|Intravenous administration as a rate-controlled infusion
16048182|NCT02538367|Drug|YH12852 DR1 2mg|
16048183|NCT02538367|Drug|YH12852 DR1 4mg|
16048184|NCT02538367|Drug|YH12852 DR2 8mg|
16048185|NCT02538367|Drug|Prucalopride 2mg|
16048186|NCT02538367|Drug|Placebo|
16048187|NCT02538354|Dietary Supplement|Riboflavin supplementation|Supplementation of the normal diet with 1 capsule of 100 mg riboflavin (vitamin B2) during three weeks
16048188|NCT02538341|Biological|Herpes Zoster Vaccine|
16048189|NCT02538341|Drug|Placebo|
16048190|NCT02538328|Device|Harmonic scapel|different surgical devices used in the obesity surgery
16048141|NCT02538601|Behavioral|CBT-A|"CBT-A was an 8-session (1.5 hours/session) group treatment for quitting smoking comprised of an optimized protocol that incorporated all elements of the CBT-S treatment plus skills for reducing PTSD/anxiety symptoms and improving tolerance to withdrawal. The CBT-A intervention included skills based on a transdiagnostic approach: (1) repeated interoceptive exposures to feared bodily sensations (e.g., dizziness, racing heart); (2) corrective information about anxiety and cognitive restructuring of catastrophic misinterpretations of somatic sensations (e.g., I will lose control.); and (3) use of graduated in-vivo exposure to feared and avoided situational experiences related to anxiety, WTC-related PTSD triggers, and smoking (e.g., going to lower Manhattan; driving without smoking)."
16048142|NCT02538601|Behavioral|CBT-S|CBT-S was an adapted group-based CBT smoking cessation treatment delivered in 8 sessions (1.5 hours/session) based on the most recent clinical practice guidelines from the United States Department of Health and Human Services (USDHHS), Treating Tobacco Use and Dependence. Standard cessation elements included psychoeducation on reasons for smoking and barriers to quitting, enlisting social support, monitoring and tapering cigarette use, and counseling regarding high-risk smoking situations and unhelpful ways of thinking about smoking and abstinence. The treatment was similar to protocols used in other smoking cessation research.
16048143|NCT02538588|Device|Nebulizer 1|
16048144|NCT02538588|Device|Nebulizer 2|
16048145|NCT02538575|Other|6-minute walk test|a walk of 6 minutes repeated twice in an interval of 30 minutes
16048146|NCT02538549|Behavioral|ACE4|Activity Challenge 4 is a single player card game that is based on principles of behavioral activation. The game was used with crisis and transitional case management clients, with positive feedback.
16048147|NCT02538536|Drug|PBI4050|
16048148|NCT02538523|Device|Erchonia FX-635|The Erchonia FX-635 is applied to the lower back and hips area for 20 minutes per treatment administration, 8 times across 4 weeks, 2 times per week.
16048149|NCT02538523|Device|Placebo Laser|The Placebo Laser is applied to the lower back and hips area for 20 minutes per treatment administration, 8 times across 4 weeks, 2 times per week.
16048150|NCT02538510|Other|Laboratory Biomarker Analysis|Correlative studies
16048151|NCT02538510|Biological|Pembrolizumab|Given IV
16048152|NCT02538510|Drug|Vorinostat|Given PO or via PEG
16048153|NCT02538497|Behavioral|The Newborn Behavioral Observation (NBO)|"The Newborn Behavioral Observation (NBO) is a flexible parental guidance methodology which takes between 20 and 40 minutes to administer. It consists of 18 neurobehavioral observations which give a profile of the infant´s behavioral repertoire along the dimensions: attentional-interactional, autonomic, motor and state organization.
~The intervention group will receive 3 NBO consultations: 1) Routine care plus the NBO at the hospital within two days post-delivery; 2) Routine home visit plus the NBO by a public health nurse when the infant is 7-10 days old; and 3) NBO at the well-baby clinic when the infant is about 4 weeks old."
16048154|NCT02538497|Behavioral|Routine care|The control group will receive routine care. Between 7 and 10 days after birth a public health nurse routinely visits the family at home. Six weeks after birth, the mother and the infant visit the well-baby clinic
16048155|NCT02538484|Drug|Letrozole|Aromatase inhibitor
16048156|NCT02538484|Dietary Supplement|Fish Oil|Omega-3 free fatty acid
16048157|NCT02538471|Radiation|Radiation therapy|Imaging by PET/CT will be performed at baseline, 5 weeks and 15 weeks. The chosen metastatic sites will receive conformal external beam radiation 7.5 Gy/fraction x 3, to a total of 22.5 Gy over the course of one week.
16048158|NCT02538471|Drug|Study Drug|Patients will receive 300 mg/day of study drug administered via oral drug tablet every day for 14 days on and 14 days off (=28 day cycle) .
16048159|NCT02538458|Drug|3 % hypertonic saline up to 72H|Treatment by inhalation of 3 % hypertonic saline, up to 72H. Test group.
16048160|NCT02538458|Drug|3 % hypertonic saline up to 24H|"Treatment by inhalation of 3 % hypertonic saline, up to 24H.
~followed by 48h of placebo : isotonic saline inhalation. Placebo control group."
16048161|NCT02538445|Other|Memorization of the verbs by miming the action|The participant reads aloud the verbs that appear on the screen, by performing the corresponding action verb.
16048162|NCT02538445|Other|Memorization of the verbs by imagining the action|The participant reads aloud the verbs that appear on the screen, by imagining the corresponding action verb.
16048163|NCT02538445|Other|Memorization of the action verbs by means of another word|The participant reads aloud the verbs that appear on the screen. Then, he reads, without memorizing it, a word associated with the action verb to be learnt to favor the memorization of that one. The word is written near the action verb.
16048164|NCT02538445|Other|Simple memorization of the verbs|The participant reads aloud the verbs that appear on the screen, without additional instructions (control condition).
16048165|NCT02538432|Drug|RQ-00000007|RQ-07 250 mg will taken orally, with or without food, each morning and evening, approximately 12 hours apart. Drug administration will be continuous. Every 21 day period will be considered one cycle of treatment.
16048166|NCT02538432|Drug|Gemcitabine|For patients with breast or lung cancer who have not previously received gemcitabine as part of their therapy or who may benefit from re-challenge with gemcitabine, gemcitabine will be administered at 1000 mg/m2 IV over 30 minutes for 3 out of 4 weeks after appropriate pre-medications. Every 4 week period (28 days) will be considered one cycle.
16048167|NCT02538419|Behavioral|CPAP + Peer Support|
16048168|NCT02538419|Behavioral|CPAP + Individual Education|
16048169|NCT02538406|Other|Segmental withdrawal|Interventional group will have at least 3 minutes dedicated to the right side of the colon during segmental withdrawal.
16048170|NCT02538393|Drug|Sorafenib (BAY43-9006) Film-coated tablet|Subjects received a single oral dose of 400 mg sorafenib marketed tablets (2 * 200 mg) in fasting state in Treatment A
16048171|NCT02538393|Drug|Sorafenib (BAY43-9006) Oral suspension|Treatment C: Subjects received a single oral dose of 200 mg sorafenib tablets for oral suspension (2 * 100 mg) in fasting state in the second intervention period; Treatment B: Subjects received a single oral dose of 400 mg sorafenib tablets for oral suspension (4 * 100 mg) in fasting state in the third intervention period; Treatment D: Subjects received a single oral dose of 400 mg sorafenib tablets for oral suspension (4 * 100 mg) after a high-fat, high-calorie breakfast (fed state) in the fourth intervention period.
16048172|NCT02538380|Procedure|EUS-B-FNA followed by EUS-FNA for LAG analysis|
16048173|NCT02538367|Drug|YH12852 IR 0.05mg|
16048174|NCT02538367|Drug|YH12852 IR 0.1mg|
16048191|NCT02538328|Device|Ligasure|Bipolar vessel sealing system used in obesity surgery
16048192|NCT02538315|Drug|[18F]FDOPA PET/CT|Implantation of fetal dopaminergic stem cell transplantation by neuro-surgeon followed by [18F]FDOPA PET/CT imaging
16048193|NCT02538302|Drug|Minirin|Minirin 5 to 10 mg daily for 6 months
16048194|NCT02538302|Drug|Oxybutynin|Oxybutynin 5 to 10 mg daily for 6 months
16048195|NCT02538289|Behavioral|Teaching talks|Two teaching talks specifically addressed to medical staff which concerns the adequate treatment and needs of dyspneic patients, including pharmacological and non-pharmacological treatment.
16048196|NCT02538263|Device|Volume-targeted noninvasive ventilation|
16048197|NCT02538250|Dietary Supplement|Nutricomp Drink Plus|Oral nutritional supplementation
16048198|NCT02538237|Drug|placebo|the mouthwash(ibuprofen 2% or placebo) Subgingival Irrigation of mouthwash with an insulin syringe 0.5 ml were rinsed.
16048199|NCT02538237|Drug|Ibuprofen 2% mouthwash|
16048200|NCT02538224|Drug|2.5%ketoprofen gel + 3 % doxycycline|"GroupA:(0.05cc, mixed gel) be put into the periodontal pocket using an insulin syringe.
~Intervention category Treatment: drugs"
16048201|NCT02538224|Drug|:2.5%ketoprofen gel|GroupB:2.5%ketoprofen gel which be inserted into the periodontal pocket using an insulin syringe .
16048202|NCT02538211|Biological|Rotavirus vaccine, Tetanus vaccine and Pneumococcal vaccine|All subjects will be given an oral dose of the rotavirus vaccine, RotarixTM, and intramuscular injections of the Tetanus vaccine and Pneumococcal vaccine, Pneumo 23.
16048203|NCT02538198|Drug|Lenalidomide|
16048204|NCT02538185|Device|NanoJect device (DebioJect™)|The investigational device used in this study is the NanoJect™ device developed by Debiotech company.
16048205|NCT02538185|Device|Classical syringe (1mL Becton Dickinson (BD) Luer-Lock™) with a 25 Guage (G) needle (Terumo® Neolus)|The comparator device used for standard ID injections is a classical syringe (1mL BD Luer-Lock™) with a 25G needle (Terumo® Neolus)
16048206|NCT02538185|Device|Classical syringe (1mL BD Luer-Lock™) with a 22G needle (Terumo® Neolus)|The comparator device used for standard IM injections is a classical syringe (1mL BD Luer-Lock™) with a 22G needle (Terumo® Neolus)
16048207|NCT02538185|Drug|Vaccin rabique Pasteur®|
16048208|NCT02538185|Drug|Placebo|Sodium Chloride (NaCl) 0,9%; B. Braun
16048209|NCT02538172|Other|T-Track® CMV assay|
16048210|NCT02538159|Device|CVC|The inclusion of any CVC is an aseptic technique, so hand washing, mask, cap is required, sterile gloves and scoping insertion using sterile drapes. The skin disinfection is carried out with 2% chlorhexidine alcohol 17, to be dried completely before insertion of the catheter (30 seconds). No prophylactic antibiotic was administered before insertion. In the case of CVC, the subclavian vein of choice will be followed by the femoral and jugular. Seldinger technique with direct radiation control in the operating room is used.
16048211|NCT02538159|Device|PICC|The inclusion of any PICC is an aseptic technique, so hand washing, mask, cap is required, sterile gloves and scoping insertion using sterile drapes. The skin disinfection is carried out with 2% chlorhexidine alcohol 17, to be dried completely before insertion of the catheter (30 seconds). No prophylactic antibiotic was administered before insertion. PICC vein of choice is the basilica vein with help of Ecography in the interventional radiology room.
16048212|NCT02538146|Dietary Supplement|acetyl-L-carnitine 1000mg 2X per day for 3 months|non-essential dietary amino acid
16048213|NCT02538133|Biological|99mTc-Exametazime (HMPAO)-labeled leukocytes|Hybrid tomoscintigraphy with labeled leucocytes for patients with suspected vascular prosthesis infection
16048214|NCT02538120|Other|Microvascular assessment|Microvascular assessment
16048215|NCT02538107|Drug|Methoxy-polyethyleneglycol epoetin beta|
16048216|NCT02538094|Device|Sham Transcranial direct current stimulation|Delivery of sham stimulation for 30 minutes using Neuro-Conn Direct Current (DC) Stimulator Plus.
16048217|NCT02538094|Device|Anodal Transcranial direct current stimulation|Delivery of transcranial direct current stimulation for 30 minutes.
16048218|NCT02538081|Drug|Risperidone plus Placebo|Standard of care including Risperidone plus Placebo
16048219|NCT02538081|Drug|Risperidone plus DMXB-A|Standard of care including Risperidone plus DMXB-A
16048220|NCT02538068|Behavioral|Daily Surveys|Participants complete 28 daily surveys of daily meaning, mood, and physical activities.
16048221|NCT02538068|Behavioral|Random Surveys (8)|Participants complete 8 random surveys of activities over the past 24 hours during the first 4 weeks.
16048222|NCT02538055|Behavioral|Living Healthy|This intervention tested the effects of a community health worker delivered lifestyle modification program based on cognitive behavioral therapy on diabetes and pain outcomes in individuals with diabetes and chronic pain.
16048223|NCT02538055|Behavioral|General Health Program|Participants in this arm worked with a Community Health Worker (CHW) who provided a general health program that consisted of didactic information of unrelated general health information. Participants received the same number of contacts with their CHW as the intervention arm. Participants and CHW interacted by telephone 8 times over 3 months.
16048224|NCT02538042|Drug|Nicotine Patch|Both groups will receive nicotine patches (21 mg/d if smoking ≥10 cigs/d or 14 mg/d if smoking <10 cigs/d) to wear for 3 weeks prior to the quit date. After the quit date, both groups will wear the nicotine patch for 10 weeks. Participants that smoked ≥10 cigs/d will wear a 21 mg/d patch for 6 weeks, a 14 mg/d patch for 2 weeks, and a 7 mg/d patch for 2 weeks. Participants that smoked <10 cigs/d will wear a 14 mg/d patch for 6 weeks, then step down to a 7 mg/d patch for 4 weeks.
16048225|NCT02538042|Drug|SPECTRUM Nicotine Research Cigarettes (0.07 mg)|For 3 weeks prior to their quit day, participants will switch to smoking SPECTRUM Nicotine Research Cigarettes instead of their usual brand.
16048226|NCT02538042|Behavioral|MCE+|During the 3-week, pre-quit period, participants will undergo six, 60 minute sessions during which they will view smoking-related environments and smoke their assigned cigarettes.
16048227|NCT02538042|Behavioral|MCE-|During the 3-week, pre-quit period, participants will undergo six, 60 minute sessions during which they will view nature environments and smoke their assigned cigarettes.
16048228|NCT02538029|Behavioral|Dual Task Group|Performing motor-motor or motor-cognitive tasks at the same time.
16048229|NCT02538029|Behavioral|Single Task Group|Performing motor or cognitive tasks alone.
16048230|NCT02538016|Drug|Tolvaptan|
16048231|NCT02538003|Drug|LCB01-0371 Tablet 800 mg(R)|Reference: taken drug before meal
16048332|NCT02537366|Drug|Dexmedetomidine|
16048232|NCT02538003|Drug|LCB01-0371 Tablet 800 mg(T)|Test: taken drug after meal
16048233|NCT02537977|Biological|CD19-directed CAR-T cells|CD19-directed CAR-T cell infusion will be given by vein
16048234|NCT02537964|Other|washcloths impregnated with 2% chlorhexidine gluconate|All infants in the NICU eligible for the study will be assigned for bathing three times a week with washcloths impregnated with 2% chlorhexidine gluconate
16048235|NCT02537951|Device|AFI microscope|measurement of AFI intensities following increasing nociceptive stimulus intensities
16048236|NCT02537951|Device|negative control 1: lidocaine/prilocaine|measurement of AFI intensities following lidocaine/prilocaine cream
16048237|NCT02537951|Device|negative control 2: 8% capsaicin|measurement of AFI intensities following 8% capsaicin patch
16048238|NCT02537938|Drug|NGP 555|
16048239|NCT02537925|Drug|Celecoxib|Celecoxib 200mg bid po, to the end of concurrent radiotherapy
16048240|NCT02537925|Drug|Nedaplatin|40 mg/m2, IV (in the vein) on day 1 of each 7 day cycle. Number of Cycles: to the end of concurrent radiotherapy
16048241|NCT02537925|Radiation|Concurrent Radiotherapy|The standard radiotherapy schedules were available as conventional radiotherapy and Intensity Modulated Radiotherapy (IMRT). The cumulative radiation dose was 68~74 Gy for primary tumor (2.0~2.3 Gy/f/day, 5 day/ week, /6~7 weeks), and 50~54 Gy for lymphatic positive area (1.8 ~ 2 Gy/f/day, 5 day/week, /5.0~5.5 weeks).
16048242|NCT02537912|Dietary Supplement|Sugarlock®|Subjects ingested 2 capsules (Experimental group) in the morning and 2 capsules in the evening (4 capsules/d) for a total of 6 weeks. Anthropometric measurements such as body weight, body fat, waistline, hipline, blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST and ALT were measured every three weeks. Five subjects were randomly selected to take MRI abdominal scans before and after the trial. After 6-week consumption, anthropometric measurements were examined on week 8 for a follow-up observation.
16048243|NCT02537912|Dietary Supplement|Placebo|Subjects ingested 2 capsules placebo in the morning and 2 capsules in the evening (4 capsules/d) for a total of 6 weeks. Anthropometric measurements such as body weight, body fat, waistline, hipline, blood pressure (systolic blood pressure [SBP] and diastolic blood pressure [DBP]) and blood biochemical parameters including FBG, albumin, TC, TG, HDL-C, LDL-C, Cr, BUN, AST and ALT were measured every three weeks. Five subjects were randomly selected to take MRI abdominal scans before and after the trial. After 6-week consumption, anthropometric measurements were examined on week 8 for a follow-up observation.
16048244|NCT02537899|Drug|NeuroAiD|
16048245|NCT02537886|Device|Patient Centered Virtual Multimedia Interactive Informed Consent tool (VIC)|Six asthma patients will comprise this post-launch focus group, with the goal of gathering opinions, beliefs, and attitudes about VIC.
16048246|NCT02537873|Drug|Lorcaserin|Lorcaserin HCL 10mg tablets (Belviq, Arena Pharmaceuticals)
16048247|NCT02537873|Drug|Cocaine Intravenous (IV)|Cocaine IV administered at doses of 10, 20 and 40 mg during 4 dosing sessions
16048248|NCT02537873|Drug|Placebo comparator|Dextrose in gelatin capsule
16048249|NCT02537860|Other|Paravertebral block injections from T12 to L2|Three anesthetic injections are done
16048250|NCT02537860|Other|Placebo at T11 and L3|Two injections that contain saline are performed
16048251|NCT02537860|Other|Paravertebral block injections between T11 and L3|Five anesthetic injections are done
16048252|NCT02537860|Procedure|Herniorrhaphy|Unilateral inguinal hernia repair
16048253|NCT02537860|Drug|Intravenous (IV) fentanyl|Patients will be given 1 μg/kg intravenous (IV) fentanyl as premedication
16048254|NCT02537860|Drug|Bupivacaine|Each patient will receive 75 mg bupivacaine during PVB
16048255|NCT02537847|Drug|Sitafloxacin|The patients in intervention group will receive carbapenem for the first 3 days then sitafloxacin for 7 days. Total of treatment duration is 10 days.
16048256|NCT02537847|Drug|Ertapenem|Control group will be given ertapenem only for 10 days.
16048257|NCT02537834|Drug|Tofogliflozin|
16048258|NCT02537834|Drug|GLP-1 analogue|
16048259|NCT02537795|Device|deep brain stimulation|Electrical stimulation of the anterior limb of the internal capsule or bed nucleus of the stria terminalis
16048260|NCT02537795|Procedure|anterior capsulotomy|
16048261|NCT02537782|Device|Cardiac resynchronisation therapy|
16048262|NCT02537782|Other|Echocardiography|
16048263|NCT02537782|Other|Magnetic Resonance Imaging|
16048264|NCT02537782|Other|Positron Emission Tomography|
16048265|NCT02537769|Device|Left ventricular assist device (LVAD)|Left ventricular assist device placement (LVAD). All participants will receive an LVAD as a part of routine care for their advanced heart failure.
16048266|NCT02537769|Procedure|Tricuspid Valve Repair (TVR)|Participants will be randomly assigned to receive a tricuspid valve repair (TVR) to repair their tricuspid valve regurgitation in addition to an LVAD placement. Only half of enrolled participants will receive this procedure.
16048267|NCT02537756|Behavioral|Project Voice|A tablet-based intervention that directs participants through different activities related to adolescent HPV vaccination based on their assigned condition
16048268|NCT02537730|Device|Bioclean MPS VII|PHMB (Polyhexamethylene biguanide) base Disinfecting and Cleaning system
16048269|NCT02537730|Device|Aosept Clearcare|Hydrogen Peroxide Disinfecting and Cleaning system
16048270|NCT02537730|Device|comfilcon A|contact lens
16048271|NCT02537717|Device|Sapphire Lens|Each subject randomized to wear either the test or control in either the left of right eye.
16048272|NCT02537717|Device|enfilcon A|Each subject randomized to wear either the test or control in either the left of right eye.
16048273|NCT02537704|Behavioral|Group Lifestyle Balance Program|
16048274|NCT02537691|Drug|FP|ICS consisting of FP will be administered by DPI (or equivalent) as per investigator discretion.
16048275|NCT02537691|Drug|LABA|LABA will be administered as per investigator discretion.
16048276|NCT02537691|Drug|LTRA|LTRA will be administered as per investigator discretion.
16048277|NCT02537691|Drug|LAMA|LAMA will be administered as per investigator discretion.
16048278|NCT02537691|Drug|Theophylline|Theophylline will be administered as per investigator discretion.
16048279|NCT02537691|Drug|Oral Corticosteroids|Oral corticosteroids will be administered as per investigator discretion.
16048333|NCT02537366|Drug|Placebo|
16048280|NCT02537678|Behavioral|Stepped Care TF-CBT|Stepped Care TF-CBT: Patients will receive Step One: 3 (1 hr.) in-office therapist-led sessions over 6 weeks, the parent-child workbook (Stepping Together),60, 61 scheduled weekly phone meetings (15 minutes), and information from the Stepping Together website and the National Center for Childhood Traumatic Stress website (via web or paper for those without access). Children who do not meet responder status will receive Step Two: 9 (1.5 hr.) in-office therapist-directed sessions of TF-CBT over 6 to 8 weeks
16048281|NCT02537678|Behavioral|Standard TF-CBT|Standard TF-CBT: Patients will receive 12 (1.5 hr.) standard weekly in-office therapist-directed sessions (2 additional weeks allow for scheduling difficulty). TF-CBT includes child, parent and conjoint parent-child sessions addressing the 10 core trauma treatment components of TF-CBT (e.g., parenting skills, affect modulation, cognitive coping, trauma narrative, etc.).
16048282|NCT02537665|Other|heating precondition|
16048283|NCT02537652|Other|Blood pressure assessment|Participants will undertake an overnight fast prior to each assessment (only water is allowed to be consumed prior to the assessment). Participants will take their medication the morning of each assessment in accordance with the normal pharmacological management procedures which are used on the acute stroke ward at the Royal Hampshire County Hospital. Following this, participants will rest supine (on an electrically operated bed) for a minimum of 15 minutes. Oscillometric pressure waveforms (using the SphygmoCor XCEL), recorded on the left upper arm, will assess haemodynamic parameters including central and peripheral blood pressure, pulse pressure, and augmentation index (fasted, supine condition).
16048284|NCT02537639|Device|Transesophageal echocardiography simulator|
16048285|NCT02537626|Device|Erchonia ALS Laser|The Erchonia ALS Laser is administered to the subject's frontal cortex, temporal regions and base of the skull 8 times across 4 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration. The total energy delivered to the subject per procedure administration is 22.5 joules.
16048286|NCT02537626|Device|Placebo Laser|The Placebo Laser is administered to the subject's frontal cortex, temporal regions and base of the skull 8 times across 4 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration. There is no energy delivered to the subject.
16048287|NCT02537613|Drug|Obinutuzumab|Obinutuzumab given weekly during cycle 1, then monthly during cycles 2-6
16048288|NCT02537613|Drug|Ibrutinib|Ibrutinib given once daily by mouth
16048289|NCT02537600|Drug|Cobimetinib + Vemurafenib combination treatment|Patients will be treated from day 1 to day 28 with Vemurafenib and from day 1 to day 21 with Cobimetinib. Day 1 to Day 28 corresponds to one cycle of treatment.
16048290|NCT02537587|Other|Control 1|67g of control bar
16048291|NCT02537587|Other|Control 2|86g of control bar
16048292|NCT02537587|Other|15/0|66g of experimental bar 15/0
16048293|NCT02537587|Other|15/0LS|84g of experimental bar 15/0LS
16048294|NCT02537587|Other|15/5|75g of experimental bar 15/5
16048295|NCT02537587|Other|10/5|72g of experimental bar 10/5
16048296|NCT02537587|Other|10/10|80g of experimental bar 10/10
16048297|NCT02537574|Drug|NTX/BUP|Daily doses
16048298|NCT02537574|Drug|NTX/PBO-B|Daily doses
16048299|NCT02537574|Drug|PBO-N/PBO-B|Daily doses
16048300|NCT02537561|Drug|Cisplatin|
16048301|NCT02537561|Drug|Gemcitabine|
16048302|NCT02537561|Drug|Talazoparib|
16048303|NCT02537548|Other|Laboratory Biomarker Analysis|Correlative studies
16048304|NCT02537548|Procedure|Retroperitoneal Lymph Node Dissection|Undergo RPLND
16048305|NCT02537535|Other|survey|This is a cross-sectional study without specific intervention
16048306|NCT02537522|Device|Contact Lenses with 8.5 BC|Subjects will wear the marketed, daily disposable contact lenses in 8.5 BC.
16048307|NCT02537522|Device|Contact Lenses with 9.0 BC|Subjects will wear the marketed, daily disposable contact lenses in 9.0 BC.
16048308|NCT02537509|Drug|Cholecalciferol|
16048309|NCT02537509|Drug|Placebo of cholecalciferol|
16048310|NCT02537496|Procedure|Repetitive Transcranial Magnetic Stimulation|Active treatment will be delivered at 90% resting motor threshold intensity. Stimulation will be administered at 20 Hz with 25 stimulation trains of 30 stimuli each with an inter-train interval of 30 sec. Treatment will be applied in sequential order bilaterally to the left and right DLPFC.
16048311|NCT02537496|Procedure|Repetitive Transcranial Magnetic Stimulation - Sham|Same stimulation parameters and site as active condition will be used, but with placebo coil which will have minimal direct brain effects
16048312|NCT02537483|Drug|IDP-120 Gel|Investigational Product: IDP-120 Gel
16048313|NCT02537483|Drug|IDP-120 Component A|Comparator Product: IDP-120 Component A
16048314|NCT02537483|Drug|IDP-120 Component B|Comparator Product: IDP-120 Component B
16048315|NCT02537483|Drug|IDP-120 Vehicle Gel|Comparator Product: IDP-120 Vehicle Lotion
16048316|NCT02537470|Drug|Biphasic Remogliflozin Etabonate|Experimental Drug
16048317|NCT02537470|Other|Placebo|Placebo Comparator
16048318|NCT02537457|Drug|Rivaroxaban (BAY 59-7939)|Rivaroxaban granule15mg for one day
16048319|NCT02537457|Drug|Rivaroxaban (Xarelto, BAY 59-7939)|Rivaroxaban tablet15mg for one day
16048320|NCT02537444|Drug|Acalabrutinib|
16048321|NCT02537444|Drug|acalabrutinib and pembrolizumab combination|
16048322|NCT02537431|Biological|burosumab|solution for subcutaneous injection
16048323|NCT02537418|Drug|durvalumab|
16048324|NCT02537418|Drug|tremelimumab|
16048325|NCT02537405|Drug|Rivaroxaban (BAY 59-7939)|Rivaroxaban granule 10mg for one day
16048326|NCT02537405|Drug|Rivaroxaban (Xarelto, BAY 59-7939)|Rivaroxaban tablet 10mg for one day
16048327|NCT02537392|Dietary Supplement|Vitamin B Complex and Folic Acid|Daily oral dose containing 2 mg vitamin B1, 2 mg vitamin B2, 2 mg vitamin B6, 2 μg vitamin B12, 2 mg calcium pantothenate, 15 mg nicotinamide and 0.4 mg folic acid.
16048328|NCT02537392|Dietary Supplement|Iron and Folic Acid|Daily oral dose of 60 mg iron and 0.4 mg folic acid.
16048329|NCT02537392|Dietary Supplement|Folic Acid|Daily oral dose of 0.4 mg folic acid.
16048330|NCT02537379|Drug|SOF|SOF 400 mg tablets administered orally once daily
16048331|NCT02537379|Drug|COPE|COPE tablets administered orally in a divided daily weight-based dose according to the package insert for the approved Copegus® labeling in Japan (< 60 kg = 600 mg , > 60 kg to ≤ 80 kg = 800 mg, and > 80 kg = 1000 mg)
16048334|NCT02537353|Device|Metal clips|The group will be shot of adrenaline 1: 10,000 in four quadrants, associated with application of metal clips.
16048335|NCT02537353|Drug|Hemospray|The group will be shot of adrenaline 1: 10,000 in the four quadrants associated with application adsorption powder, marketed under the name Hemospray.
16048336|NCT02537353|Procedure|Endoscopy Exam|All patients will be submitted to endoscopy exam in 12 to 24 hours after the therapeutic procedure to confirm the success of the therapy and measure if there the presence of rebleeding.
16048337|NCT02537353|Drug|Adrenaline|The injection of adrenaline solution with 50% glucose at a proportion of 1: 10000 in four quadrants.
16048338|NCT02537314|Drug|benzocaine|0.5% benzocaine solution in saline/hydrochloric acid administered by intraduodenal infusion one time (6 ml bolus followed by 75 ml/hour for 105 minutes)
16048339|NCT02537314|Other|placebo|Placebo (saline) solution administered by intraduodenal infusion one time (6 ml bolus followed by 75 ml/hour for 105 minutes)
16048340|NCT02537301|Other|joining in the platform|The activities (contents, chatting frequency etc.) of ERCP doctors on the chatting group were retrospectively extracted. The data related to the performance of ERCP (such as case volume, cannulation success rate and PEP etc.) by ERCP doctors were collected by a questionaire.
16048341|NCT02537288|Drug|Fedovapagon|
16048342|NCT02537288|Drug|Moxifloxacin|
16048343|NCT02537288|Drug|Placebo (for fedovapagon)|
16048344|NCT02537275|Device|EyeLIKe Callamatch II, Koryo Eyetech Co, Seoul, Korea|tinted contact lens, daily-wear tinted lens
16048345|NCT02537275|Device|EyeLIKe Shine, Koryo Eyetech Co|clear lens
16048346|NCT02537262|Dietary Supplement|carbohydrate beverage|Carbohydrate group drinks carbohydrate beverage 400ml(9PM~MN) the day before the surgery and 200ml three hours before the surgery.
16048347|NCT02537262|Dietary Supplement|NPO(None Per Oral)|NPO group does not drink any water from the MN before the surgery.
16048348|NCT02537249|Drug|Dexmedetomidine|Formula for administrated were randomized by computer-generated randomization. The patients and anesthesiologist, who administered and conducted all this trial, were blinded to the medication allocation. An anesthesiologist, who responsible for preparation of medication was the only person, recognized of the randomization code during trial. After one-lung ventilation, dexmedetomidine group would start the loading of dexmedetomidine (1μg/kg) during 20 minutes.
16048349|NCT02537249|Drug|Normal saline|Saline placebo infusion will be adjusted the same fashion as the active comparator drug.
16048350|NCT02537236|Dietary Supplement|Omega-3 fatty acids|Omega-3 fatty acid supplementation with fish oil.
16048351|NCT02537236|Behavioral|TLC nutritional intervention|nutritional orientation.
16048352|NCT02537236|Dietary Supplement|Omega-3 fatty acid supplementation with fish oil and TLC nutritional intervention.|Omega 3 fatty acid supplementation with fish oil and nutritional counseling of TLC diet.
16048353|NCT02537223|Drug|BYL719|
16048354|NCT02537223|Drug|Cisplatin|
16048355|NCT02537223|Radiation|Intensity modulated radiation therapy (IMRT)|
16048356|NCT02537210|Drug|Mesalazine|Patients will be prescribed Asacol 2g daily for 12 months
16048357|NCT02537210|Drug|Placebo oral capsule|Patients will be prescribed placebo 5 capsules daily for 12 months
16048358|NCT02537197|Drug|Naltrexone|Regular opioid antagonist dosing of disordered gamblers
16048359|NCT02537184|Procedure|Oral Clinical conditions|caries incidence assessment dental anxiety assessment
16048360|NCT02537171|Drug|apatinib|Patients will be randomly assigned on a 1:1 basis to treatment with Apatinib 750mg group or Apatinib 500mg group.
16048361|NCT02537158|Drug|Sorafenib|sorafenib group patients will accept sorafenib therapy for one year（400 mg bid,orally).
16048362|NCT02537158|Procedure|TACE|TACE group patients will accept TACE therapy once at a month after resection.
16048363|NCT02537132|Other|Adaptation and training to Non Invasive Ventilation (NIV)|Each person recruited after a respiratory evaluation (baseline spirometry and supine, maximal inspiratory and expiratory pressures (MIP / MEP) or sniff nasal inspiratory pressure (SNIP), 6 Minute Walking Test (6MWT) -if still ambulatory, arterial blood gas, nocturnal polygraphy) will be adapted to Non Invasive Ventilation (NIV). Moreover, the subject will be brought to the management of bronchial secretions (under the terms set out herein) during not less than five outpatient or house accesses, depending on who is randomly assigned to the experimental group or the control group. These accesses will take place weekly, for a period of two months, considering both the needs and the patient's clinical condition.
16048364|NCT02537119|Procedure|Dynamic massage therapy|Dynamic massage therapy on hamstring combined with knee extension
16048365|NCT02537119|Procedure|Massage therapy|Rubbing on hamstrings
16048366|NCT02537106|Procedure|1.5% NaCl|After the infusion of 1.5% NaCl and dura opening the microcirculation and the brain relaxation score will be measured in the area of healthy brain and perifocal oedema sites. Microcirculation measurement will be repeated at the same sites after tumor resection.
16048367|NCT02537106|Procedure|3% NaCl|After the infusion of 3% NaCl and dura opening the microcirculation and the brain relaxation score will be measured in the area of healthy brain and perifocal oedema sites. Microcirculation measurement will be repeated at the same sites after tumor resection.
16048368|NCT02537093|Behavioral|Psychiatric Consultation|
16048369|NCT02537080|Drug|Nimodipine group|the stability of the blood pressure will be managed in interval plus minus 15% of patient's resting blood pressure
16048370|NCT02537080|Drug|Control group|the stability of the blood pressure will be managed in interval plus minus 15% of patient's resting blood pressure
16048371|NCT02537067|Drug|CHONDRON|"Harvesting of ankle or knee cartilage
~The cells that fill the vial are sufficiently suspended, and a sufficient amount of suspension is grafted in the defect with fibrin glue."
16048372|NCT02537054|Drug|Aflibercept|Intravitreal injection
16048373|NCT02537041|Procedure|elastography function ShearWave Imaging|non-invasive assessment of myocardial stiffness by elastography
16048374|NCT02537041|Procedure|MRI|
16048375|NCT02537028|Drug|MSC2364447C|Subjects will be administered with MSC2364447C 25 milligrams orally once daily for 4 weeks.
16048376|NCT02537028|Drug|MSC2364447C|Subjects will be administered with MSC2364447C 75 milligrams orally once daily for 4 weeks.
16048377|NCT02537028|Drug|Placebo|Subjects will be administered with placebo matching to MSC2364447C orally once daily for 4 weeks.
16049045|NCT02532036|Biological|Intramuscular Saline placebo|
16048378|NCT02537015|Drug|Bimatoprost|Bimatoprost Ocular Insert in each eye used continuously for 12 weeks, then replaced with a new Bimatoprost Ocular Insert in each eye used continuously for another 26 weeks.
16048379|NCT02537002|Drug|PF-05230907|A single intravenous dose of 3 μg/kg
16048380|NCT02537002|Drug|PF-05230907|A single intravenous dose of 5 μg/kg
16048381|NCT02537002|Drug|Placebo|A single intravenous dose of matched placebo
16048382|NCT02536989|Drug|omeprazole|receive intravenous omeprazole 80 mg stat and then 8mg/hr infusion for 3 days
16048383|NCT02536989|Drug|omeprazole|receive intravenous omeprazole 40 mg stat and then 40 mg q12h for 3 days
16048384|NCT02536976|Drug|mirabegron|
16048385|NCT02536976|Drug|Placebo|
16048386|NCT02536963|Device|Pediatric Vision Scanning device|The Pediatric Vision Scanner (PVS) performs a 3-second, non-invasive scan of both eyes simultaneously while a child looks at a single target. The scan will measure the frequency of the light waves that reflect off of the participants' eyes to determine the fixation state of the eye.
16048387|NCT02536963|Other|Reference examination|Reference examination of the eyes will be performed by a fellowship-trained pediatric ophthalmologist.
16048388|NCT02536950|Device|Fixed set point|Fixed set point arm: A fixed setpoint will be used initially. Staff will observe glucose control over 2 days while subjects remain in a hotel environment, and then over 5 more days in the same subjects in an outpatient setting. The clinical staff will adjust this target up or down by 15 mg/dl based on their glycemic control in the hotel setting.
16048389|NCT02536950|Device|Variable set point|Variable set point arm: The setpoint will be variable over a 30 mg/dl range and glycemic control will be optimized based on the preceding 24-hour window.
16048390|NCT02536937|Drug|eliglustat|"Pharmaceutical form: capsule
~Route of administration: oral"
16048391|NCT02536924|Behavioral|Waiting Room Intervention|The waiting room intervention is called RESOLVE (Relaxation SOLving problem and cognitive errors), which is a short film.
16048392|NCT02536924|Behavioral|Treatment as usual.|The patient will receive treatment as usual.
16048393|NCT02536911|Drug|eliglustat|"Pharmaceutical form: capsule
~Route of administration: oral"
16048394|NCT02536898|Other|Fracture Liaison Service|
16048395|NCT02536898|Other|Current treatment|
16048396|NCT02536885|Procedure|Liberal group|If the pressure decreases below 75% of patient's baseline mean arterial pressure for more than 1 min, continuous application of noradrenalin will be initiated. If the blood pressure increases above 125% of patient's baseline mean arterial pressure for more than 1 min, Ebrantil (urapidil hydrochlorid) will be applied in dose of 5 mg intravenously with the possibility of repeated doses in 2 minutes intervals.
16048397|NCT02536885|Procedure|Restrictive group|If the pressure decreases below 90% of patient's baseline mean arterial pressure for more than 1 min, continuous application of noradrenalin will be initiated. If the blood pressure increases above 110% of patient's baseline mean arterial pressure for more than 1 min, Ebrantil (urapidil hydrochlorid) will be applied in dose of 5 mg intravenously with the possibility of repeated doses in 2 minutes intervals.
16048398|NCT02536872|Other|None - this is a prospective observational study. Patients will be prescribed their usual treatment (antibiotics) and the effect on urine studied|
16048399|NCT02536859|Drug|insulin degludec|Dose levels will be 0.4 U/kg body weight. The trial products will be administered subcutaneously (s.c., under the skin) once daily.
16048400|NCT02536859|Drug|insulin glargine|Dose levels will be 0.4 U/kg body weight. The trial products will be administered subcutaneously (s.c., under the skin) once daily.
16048401|NCT02536846|Drug|Olanzapine|All subjects will take a single 2.5 mg dose of olanzapine (Zyprexa Zydis) followed by a 5 mg dose for 14 days. (2.5 mg/d for 1 day, 5 mg/d for 14 days).
16048402|NCT02536833|Drug|SM04690|
16048403|NCT02536833|Drug|Placebo|
16048404|NCT02536820|Behavioral|psychoneuroimmune therapy|
16048405|NCT02536820|Drug|Conventional treatment|Actual diabetes treatment in each participant
16048406|NCT02536807|Drug|Hyaluronan|HA gel injection
16048407|NCT02536794|Biological|Anti-B7H1 Monoclonal Antibody MEDI4736|Given IV
16048408|NCT02536794|Other|Laboratory Biomarker Analysis|Correlative studies
16048409|NCT02536794|Other|Pharmacological Study|Correlative studies
16048410|NCT02536794|Biological|Tremelimumab|Given IV
16048411|NCT02536781|Drug|Anthocyanin|Anti-inflammation gel
16048412|NCT02536781|Drug|Placebo|Blank gel
16048413|NCT02536768|Behavioral|Minimum package of interventions to improve ART adherence|Package of 5 interventions to antiretroviral therapy adherence including fast track initiation counselling, decentralized drug delivery, adherence clubs, fast patient tracing and spaced visits
16048414|NCT02536755|Drug|eliglustat GZ385660|"Pharmaceutical form: capsule
~Route of administration: oral"
16048415|NCT02536742|Drug|Palbociclib|125 mg, orally, daily for 3 weeks followed by 1 week off; repeated at every 28 days cycle until progression, lack of tolerability, or patient declines further protocol treatment.
16048416|NCT02536742|Drug|Fulvestrant|500mg, intramuscularly on days 1 and 15 of cycle 1, then on day 1 (+/- 3 days) of every 28 days cycle until progression, lack of tolerability, or patient declines further protocol treatment.
16048417|NCT02536729|Drug|Oral Sodium Phosphate - Normal preparation|
16048418|NCT02536729|Drug|Oral sodium phosphate - Modified Preparation|
16048419|NCT02536729|Drug|polyethylene glycol + Electrolytes|
16048420|NCT02536716|Procedure|Platform-matched dental implant|A platform-matched dental implant will be placed surgically, restored with a crown and evaluated for up to 12 months.
16048421|NCT02536716|Procedure|Platform-switched dental implant|A platform-switched dental implant will be placed surgically, restored with a crown and evaluated for up to 12 months.
16048422|NCT02536703|Device|Lotus Valve System|Lotus Valve System
16048423|NCT02536690|Drug|Propofol|Propofol bolus dose administration according to the predetermined dose by biased coined design up-and-down study.
16048424|NCT02536690|Drug|Remifentanil|Remifentanil 0.25 mcg/kg/min infusion for 5 min before propofol administration.
16048425|NCT02536690|Drug|Midazolam|Remifentanil 0.25 mcg/kg/min infusion for 5 min before propofol administration followed by midazolam 0.03 mg/kg administration 1 min after remifentanil infusion start.
16048426|NCT02536664|Drug|Rituximab|
16048427|NCT02536651|Procedure|Ankle surgery|Plastic or orthopedic surgery of the ankle
16048428|NCT02536638|Other|Exposure to pyelonephritis|Pyelonephritis group are patients with exposure to pyelonephritis Without pyelonephritis group are patients without pyelonephritis
16048429|NCT02536625|Other|prospective study|
16048430|NCT02536612|Other|Lottery|Opportunity for entry in lottery (each time, at months 3 and 6).
16048431|NCT02536612|Other|No Lottery|Transport compensation for study visits at baseline and at months 3 and 6. No chance to win lottery ticket.
16048432|NCT02536586|Drug|LY3023414|LY3023414 administered orally.
16048433|NCT02536573|Other|Radlink Surgical Positioning Software|
16048434|NCT02536547|Device|VAP|all patients with suspected VAP : biochemestry microbiology lung ultrasound
16048435|NCT02536534|Other|Correlation assessment|
16048436|NCT02536508|Drug|BGF MDI 320/14.4/9.6 μg|Budesonide, Glycopyrronium, and Formoterol Fumarate
16048437|NCT02536508|Drug|GFF MDI 14.4/9.6 μg|Glycopyrronium and Formoterol Fumarate
16048438|NCT02536508|Drug|BFF MDI 320/9.6 μg|Budesonide and Formoterol Fumarate
16048439|NCT02536495|Drug|Docetaxel|Given IV
16048440|NCT02536495|Other|Laboratory Biomarker Analysis|Correlative studies
16048441|NCT02536495|Other|Pharmacological Study|Correlative studies
16048442|NCT02536495|Drug|Selinexor|Given PO
16048443|NCT02536482|Dietary Supplement|Amix|Treat the children with cow's milk allergy for 5 months.
16048444|NCT02536469|Drug|HuMax-IL8|HuMax-IL8 drug product intended for intravenous infusion. Subjects will be treated every 2 weeks. Every 2 doses (4 weeks) will be considered 1 cycle
16048445|NCT02536430|Drug|Ketorolac Tromethamine|One group received a buccal infiltration of Ketorolac Tromethamine
16048446|NCT02536430|Drug|Placebo|buccal infiltration of Normal Saline.
16048447|NCT02536417|Drug|Melatonin|To determine the effectiveness of melatonin in preventing the development of delirium compared with placebo
16048448|NCT02536417|Drug|Sugar pill|To determine if placebo effect plays a part in preventing the development of delirium
16048449|NCT02536404|Drug|Etrasimod|
16048450|NCT02536404|Drug|Placebo|
16048451|NCT02536391|Drug|Ipatasertib (capsule)|Orally administered single dose of Ipatasertib formulated as a capsule.
16048452|NCT02536391|Drug|Ipatasertib (tablet)|Orally administered single dose of Ipatasertib formulated as a tablet.
16048453|NCT02536365|Behavioral|Sensory Integration Therapy|Children in the SIT treatment group will receive a manualized SIT intervention that follows the principles of sensory integration.
16048454|NCT02536365|Behavioral|Applied Behavioral Analysis|Children in the ABA treatment group will receive intervention that follows the principles of Applied Behavioral Analysis.
16048455|NCT02536352|Drug|Prenatal vitamin-mineral containing 3 mg fluoride|Prenatal vitamin-mineral containing 3 mg fluoride to be taken daily, starting at 10-20 weeks gestation until delivery.
16048456|NCT02536352|Dietary Supplement|Prenatal vitamin-mineral containing 0 mg fluoride|Prenatal vitamin-mineral containing 0 mg fluoride to be taken daily, starting at 10-20 weeks gestation until delivery.
16048457|NCT02536339|Drug|Pertuzumab|Participants will receive 840 milligrams (mg) loading dose of pertuzumab, followed every 3 weeks thereafter by a dose of 420 mg via intravenous (IV) infusion until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
16048458|NCT02536339|Drug|Trastuzumab|Participants will receive trastuzumab at a dose of 6 milligrams per kilogram (mg/kg) of body weight once weekly via IV infusion until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
16048459|NCT02536326|Device|LEPU Renal Denervation System|LEPU Renal denervation system was similar to Symplicity Catheter System (Medtronic Inc.)
16048460|NCT02536313|Drug|SOF/VEL/VOX|400/100/100 mg FDC tablet administered orally once daily with food
16048461|NCT02536313|Drug|RBV|Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
16048463|NCT02536287|Procedure|total PTX without autotransplantation|All parathyroid glands were found and removed and sent for histological confirmation,but without autotransplantation.
16048464|NCT02536287|Procedure|total PTX with autotransplantation|All parathyroid glands were found and removed and sent for histological confirmation,and then a portion of the smallest, preferably nonnodular parathyroid gland was chosen for autotransplantation,sliced into pieces measuring 1*1 *1 mm,and placed into the subcutaneous of the forearm.
16048465|NCT02536274|Device|Lumbo Sensa® bandage|Patients have to wear it over 21-28 days for at least 8 hours a day
16048466|NCT02536274|Device|Dynaflex® flexion orthosis|Patients have to wear it over 21-28 days for at least 8 hours a day
16048467|NCT02536248|Drug|Sitagliptin|Sitagliptin 100 mg/d for 6 weeks
16048468|NCT02536248|Drug|Placebo|Placebo for 6 weeks
16048469|NCT02536235|Other|heat|activated heating pad to lower abdomen
16048470|NCT02536222|Other|Case investigation of malaria passively detected cases with FT/FDA|Systematic reactive malaria case investigation will be performed in all villages of the six intervention health posts. All malaria cases passively detected in a health post or in the community and confirmed with a positive rapid diagnostic test (RDT) will be considered an index case and will be investigated. A team (field worker and community health worker) will visit the household of the index case and the five closest households (in a 100 meter radius) and will test by RDT all the consenting individuals living in the households. Any households with at least one positive RDT (including the index case) will receive a systematic focal drug administration (FDA) treatment with DHAP through which all members will be treated.
16048471|NCT02536209|Drug|MT-8554 low dose|
16048472|NCT02536209|Drug|MT-8554 high dose|
16048473|NCT02536209|Drug|Oxycodone hydrochloride|
16048474|NCT02536209|Drug|Placebo|
16048475|NCT02536196|Device|Embolic Protection Device|Embolic protection
16048476|NCT02536196|Procedure|Transcatheter aortic valve implantation (TAVI)|Transcatheter aortic valve implantation (TAVI)
16048477|NCT02536183|Device|Magnetic resonance high intensity focused ultrasound|Magnetic resonance (MR)-high intensity focused ultrasound (HIFU) provides precise controlled delivery of heat by focusing ultrasound energy inside a lesion using an external applicator that is completely non-invasive and non-ionizing.
16049040|NCT02532062|Dietary Supplement|Placebo|oral, once a day for one year
16048478|NCT02536183|Drug|Lyso-thermosensitive liposomal doxorubicin|A heat-activated formulation of liposomal doxorubicin with unique property of heat-activated release of doxorubicin, an active agent in most pediatric solid tumors.
16048479|NCT02536170|Drug|L-arginine|L-arginine will be dispensed intravenously (IV) in the standard dose of 100 mg/kg three times a day until discharge from the emergency department (ED) or hospital.
16048480|NCT02536170|Drug|L-arginine Loading Dose|One loading dose of L-arginine will be dispensed intravenously (IV) at 200 mg/kg
16048481|NCT02536170|Other|Placebo|Placebo of intravenous (IV) normal saline 1-2 ml/kg three times a day until discharge from the emergency department (ED) or hospital.
16048482|NCT02536157|Device|Thermoplastic splinting|
16048483|NCT02536144|Procedure|magnetic-controlled capsule endoscopy system|"A magnetic-controlled capsule endoscopy(MCCE) included camera,magnet,batter and high polymer material shell.
~The MCCE would be turned to sleeping mode capturing picture at a rate of 0.5 frame per second after being swallowed.
~While reaching cecum, the MCCE would be turned to a working mode capturing picture at a rate of 2 frame per second.
~The MCCE would be controlled by the Magnetic-manipulator out of body to finish the motion of e rotation, somersault, Bird's-eye view, worm's eye view from cecum to anus."
16048484|NCT02536144|Procedure|Colonoscopy|"Bowel preparation should be well done before the examination.
~A tube with illumination and camera system would insert into colon from anus.
~From the pictures captured by the camera ,the doctor would see the mucous of the colon."
16048485|NCT02536131|Other|Gut-directed hypnotherapy|relaxation technique with hypnotic induction and suggestions aimed at fostering sense of control, acceptance and calming of bowels.
16048486|NCT02536118|Device|Micra Transcatheter Pacing System|The Micra system is a miniaturized single chamber pacemaker system that is delivered via catheter through the femoral vein and is implanted directly inside the right ventricle of the heart. The Micra implantable device is a self-contained, hermetically enclosed, miniaturized single chamber pacemaker. The device is fixated via four electrically inactive nitinol tines, located on the distal end of the device.
16048487|NCT02536105|Drug|Methylphenidate HCl ER tablets 1|
16048488|NCT02536105|Drug|Placebo|
16048489|NCT02536105|Drug|Methylphenidate HCl ER tablets 2|
16048490|NCT02536105|Drug|Methylphenidate HCl ER for suspension|
16048491|NCT02536092|Device|755nm and 1064nm Nd:YAG laser|Dual wavelength 755nm and 1064nm Nd:YAG laser
16048492|NCT02536079|Drug|NeuroAiD|
16048493|NCT02536066|Behavioral|Postprandial physical activity|Adding a minimum of 30 minutes of physical activity starting maximum 30 minutes after the last meal daily
16048494|NCT02536053|Procedure|Limb salvage|
16048495|NCT02536040|Drug|38% diammine silver fluoride|treatment of cavity with study agent
16048496|NCT02536040|Other|Water|Fluoride free, distilled water
16048497|NCT02536027|Procedure|continuous venovenous hemofiltration|Continuous renal replacement therapy (CRRT) has become routine for patients with AKI, chronic renal failure, ﬂuid overload as well as oliguria in ICU. In clinical practice, continuous venovenous hemofiltration (CVVH) is actually the method of choice for CRRT in critically ill and hemodynamic instable patients. CVVH has significant beneficial effects on removing inflammatory cytokines, improving oxygen index, decreasing vasopressor requirements, increasing cardiac index, and regulating immune dysfunction, specifically in patients with septic shock.
16048498|NCT02536014|Drug|Dexmedetomidine|Dexmedetomidine infusion (0.3㎍/kg/hr) from anesthetic induction to the end of pneumoperitoneum
16048499|NCT02536014|Drug|Saline|Saline infusion during the same time period
16048500|NCT02536001|Device|One mesh Endofast reliant system|One mesh (anterior One mesh Endofast reliant system) will be used to correct both anterior and apical prolapse
16048501|NCT02536001|Device|two meshes Endofast reliant system|Two meshes (anterior and posterior Endofast reliant system) will be used to correct separately the anterior compartment and the apical compartment
16048502|NCT02535988|Radiation|Radiation therapy|3.5Gy per fraction to a total dose of 35Gy/10 fractions over 2 weeks with concurrent thymalfasin for metastatic lesions of colorectal cancer.
16048503|NCT02535988|Drug|Thymalfasin|Patients with metastatic lesions of colorectal cancer receiving 3.5Gy per fraction to a total dose of 35Gy/10 fractions over 2 weeks with concurrent thymalfasin ( given twice a week with an interval of 3-4 days each week).
16048504|NCT02535975|Drug|Metformin|Tablets metformin 500 mg PO three times a day for 24 weeks
16048505|NCT02535975|Drug|Placebo|Tablets placebo PO three times a day for 24 weeks
16048506|NCT02535962|Biological|Lactobacillus acidophilus and Bifidobacterium lactis|study product will be freeze dried and put into foil sachets
16048507|NCT02535962|Other|Placebo|Placebo will look and taste like the investigational product. This also will be provided in a foil sachets
16048508|NCT02535949|Drug|Tranexamic Acid|Tranexamic acid is a man-made form of an amino acid (protein) called lysine. Tranexamic acid prevents enzymes in the body from breaking down blood clots.
16048509|NCT02535949|Other|Placebo|Matching Volume Normal Saline Placebo given IV over 10 minutes within 2 hours of initial injury
16048510|NCT02535936|Procedure|3Tesla MRI with DTI-MRI and rsfcMRI under general anesthesia|2 post-operative MRI's at 2 months and 12 months
16048511|NCT02535923|Behavioral|Cognitive Behavioral Therapy-Insomnia|CBT-I addresses cognitive, arousal and behavioral factors related to sleep difficulties. Sessions combine assessment, conceptualization, psychoeducation, behavioral strategies and cognitive therapy, using a consistent structure including review of participants' sleep log and adherence to behavioral guidelines, modification of time in bed, cognitive therapy, and relaxation techniques. CBT-I also incorporates psychoeducation about biological and psychological elements that regulate sleep. Other strategies include stimulus control (i.e., getting out of bed when not sleepy) to extinguish the conditioned arousal common in insomnia, and relaxation techniques to reduce arousal associated with the bed, bedroom, or bedtime.
16048547|NCT02535715|Drug|ORMD-0801 capsules- 1x16mg|Participants who receive this intervention first, then receive either ORMD-0801- 2x8mg or 3x8mg dose after a 3 day to 4 week interval. Participants receiving this drug as the second drug intervention will then receive the third intervention after a 3 day to 4 week interval. ORMD-0801 capsules are an oral insulin that has shown promise in preliminary studies. Investigators will evaluate this novel insulin preparation as a potential therapeutic option in diabetic patients.
16049041|NCT02532049|Biological|ChAd63 Pfs25-IMX313|
16048512|NCT02535923|Behavioral|Health and Wellness|Health and Wellness is a general self-management curriculum focused on providing education and support for managing physical and emotional well-being. Each session follows a basic structure including review of previous session material, new educational information and discussion on several topics over the course of single or multiple sessions. Each session will focus on the impact of the topic on overall health and wellness, identifying benefits and challenges to improving or maintaining health in that area, and strategies that clients may find helpful to address challenges in that area. Example topics include physical activity/exercise, nutrition/healthy eating, managing medications and side effects, and addictive behaviors (e.g., substance use, gambling, eating).
16048513|NCT02535910|Dietary Supplement|vitamin D3|Subjects are asked to consume a breakfast rich in 20 µg vitamin D3
16048514|NCT02535910|Dietary Supplement|25(OH) D3|Subjects are asked to consume a breakfast rich in 20 µg 25(OH)D3
16048515|NCT02535910|Dietary Supplement|Control|Subjects are asked to consume a breakfast without vitamin D
16048516|NCT02535897|Dietary Supplement|Flavoured water|
16048517|NCT02535897|Dietary Supplement|Flavoured water + carbohydrate|
16048518|NCT02535897|Dietary Supplement|Flavoured water + carbohydrate + protein|
16048519|NCT02535884|Device|ACTIVA® PC neurostimulator (Model 37601)|the stimulator in the stimulation group will be turned on after implantation of the device
16048520|NCT02535871|Drug|IDP-121 Lotion|Investigational Product: IDP-121 Lotion
16048521|NCT02535871|Drug|IDP-121 Vehicle Lotion|Comparator Product: IDP-121 Vehicle Lotion
16048522|NCT02535858|Device|Heart and respiratory rate and VE|To evaluate the effectiveness of the virtual environment (VE) as a biofeedback of chemically dependent's vulnerability front situations of risk, a total of 50 volunteers who were drug users, monitored by 10 therapists, were enrolled.
16048523|NCT02535858|Device|Heart and respiratory rate and video|Anxiety is characterized by the average variability from both heart and respiratory rate of 30 volunteers undergoing stress environment situations.
16048524|NCT02535845|Behavioral|Project Voice|Project Voice tablet-based intervention plus informational video
16048525|NCT02535845|Behavioral|HPV Informational Video|Informational video only
16048526|NCT02535832|Drug|Pioglitazone|Pioglitazone CT Scan DXA scan Needle muscle biopsy
16048527|NCT02535832|Drug|Placebo|Placebo CT Scan DXA scan Needle muscle biopsy
16048528|NCT02535819|Procedure|Subluxation|One pole of The nucleus is hydrodissected until it lilts above the capsular bag. The tilted nucleus is rotated to face the incision and remaining half nucleus is then tumbled and emulsification continues from the opposite equator outside in until complete
16048529|NCT02535819|Procedure|Divide and Conquer|Cataract nucleus is fragmented into 4 pieces then aspirated by ultrasonic vibration
16048530|NCT02535806|Drug|Velcade|4 doses of study drug will be given.
16048531|NCT02535806|Drug|Methotrexate|Intrathecal dose For CNS negative patients, Day 1 and Day 8
16048532|NCT02535806|Drug|Methotrexate / Hydrocortisone / Cytarabine|Intrathecal dose for CNS positive patients, Day 1, 8, 15, 22
16048533|NCT02535806|Drug|Dexamethasone|Days 1-5 and 15-19
16048534|NCT02535806|Drug|Mitoxantrone|Days 1 and 2
16048535|NCT02535806|Drug|Vincristine|Days 1, 8, 15, 22
16048536|NCT02535806|Drug|Pegaspargase|Days 3 and 17
16048537|NCT02535793|Other|blood test (four dry tubes 7ml) and prick tests|
16048538|NCT02535780|Procedure|Transcranial magnetic stimulation|TMS
16048539|NCT02535780|Procedure|Transcranial direct current stimulation|tDCS
16048540|NCT02535767|Drug|Primaquine|A single low dose of primaquine will be crushed and dissolved in water, and administered in weight-based doses.
16048541|NCT02535754|Behavioral|ALIVE|The company assigned to this condition offered employees participation in the ALIVE program. This program was validated in a previous worksite-based randomized controlled trial (RCT). A baseline assessment includes questions asking about: presence of children at home, habits related to cooking and eating out, physical activity preferences, stage of readiness of change, and perceived barriers to achieving heath behavior goals. This information provides the basis for immediate feedback and individually-tailored messages that include goal-setting and tips to achieve these goals, interactive features, and health information. Biweekly messages are sent for a total of 48 weeks. Outcome data were based on all individuals who completed the baseline assessment.
16048542|NCT02535754|Behavioral|CCS BCY|The company assigned to this condition participated in a comprehensive year-long workplace wellness program intervention focusing on nutrition, weight control, and physical activity, led by the CCS BCY. The program was modeled after a previous successful CCS BCY tobacco control worksite program. This program stresses the importance of developing social and environmental supports at the worksite to promote behavior change . Such supports could include food availability (e.g., cafeteria and vending machine selections), the built environment (e.g., availability of bike racks); social environment (e.g., group lunchtime walking clubs), and health communications (e.g., company newsletters). Outcome data were based on all individuals who completed the baseline assessment.
16048543|NCT02535754|Behavioral|ALIVE + CCS BCY|The company assigned to this condition received both the ALIVE and CCS BCY programs. Employees were encouraged to take part in both ALIVE and company initiatives, but participation in these activities was based on individual preference. Outcome data were based on all individuals who completed the baseline assessment.
16048544|NCT02535741|Device|Triathlon CR Total Knee System|Primary total knee replacement
16048545|NCT02535715|Drug|ORMD-0801 capsules- 2x8mg|Participants who receive this intervention first, then receive either ORMD-0801- 3x8mg or 1x16mg dose after a 3 day to 4 week interval. Participants receiving this drug as the second drug intervention will then receive the third intervention after a 3 day to 4 week interval. ORMD-0801 capsules are an oral insulin that has shown promise in preliminary studies. Investigators will evaluate this novel insulin preparation as a potential therapeutic option in diabetic patients.
16048546|NCT02535715|Drug|ORMD-0801 capsules- 3x8mg|Participants who receive this intervention first, then receive either ORMD-0801- 2x8mg or 1x16mg dose after a 3 day to 4 week interval. Participants receiving this drug as the second drug intervention will then receive the third intervention after a 3 day to 4 week interval. ORMD-0801 capsules are an oral insulin that has shown promise in preliminary studies. Investigators will evaluate this novel insulin preparation as a potential therapeutic option in diabetic patients.
16048681|NCT02534740|Drug|tafamidis|fasted
16048682|NCT02534740|Drug|tafamidis|fed
16048554|NCT02535689|Drug|Tofacitinib|Oral administration of tofacitinib, 5 mg
16048555|NCT02535689|Drug|Placebo|
16048556|NCT02535676|Device|Transcranial Direct Current Stimulation|The device will produce a direct current of 2 mA from one electrode to the other. In active stimulation, the device will be turned on for 20 min and in sham stimulation the device will be turned in 2 mA for one minute and will be automatically turned off the remaining 19 minutes. The sham or active mode is chosen by a numeric code.
16048557|NCT02535663|Dietary Supplement|RG|The 100mg Korean citrus Hallabong peel polysaccharide contained 60mg rhamnogalacturonan (RG), 20mg mono- and di-saccharide, 5mg polyphenol, 5mg ash and 10mg moisture
16048558|NCT02535663|Dietary Supplement|Placebo|Same product without RG
16048559|NCT02535650|Drug|tipifarnib|Tipifarnib will be administered at a starting dose of 900 mg, po, bid on days 1-7 and 15-21 of 28-day treatment cycles. In the absence of unmanageable toxicities, subjects may continue to receive tipifarnib treatment for up to 12 months as long as the Investigator considers that the treatment is providing clinical benefit.
16048560|NCT02535637|Other|Exclusively breastfeed|There is no intervention other than mothers must exclusively breastfeed.
16048561|NCT02535624|Procedure|PACKING|By retroperitoneal access the space in front of the pelvic fracture is compressed with surgical towels, which stops effectively venous bleeding
16048562|NCT02535624|Procedure|ANGIO|Using en endovascular approach, bleeding arteries are identified and clotted using embolizing agents, or coils.
16048563|NCT02535611|Drug|Placebo|Beside the usual treatment of ischemic stroke, this group will receive placebo for 4 weeks.
16048564|NCT02535611|Drug|Memantine|Beside the usual treatment for ischemic stroke this group will be treated by memantine.
16048565|NCT02535598|Behavioral|Normal presentation|All the material will be presented as plain text.
16048566|NCT02535598|Behavioral|Enhanced presentation|The material of the intervention is designed to be as appealing as possible with clear organization, animated presentations, ample illustrations, etc.
16048567|NCT02535598|Behavioral|Normal support|Participants receive semi-standardized support once a week and there will be no formal training or competence.
16048568|NCT02535598|Behavioral|Enhanced support|Participants are offered daily support through the internet from trained therapists.
16048569|NCT02535585|Device|knotted anchors (SutureTak biocomposite 3.0 mm)|Arthroscopic repair of the labral lesion with knotted anchors (SutureTak biocomposite 3.0 mm).
16048570|NCT02535585|Device|knotless anchors (PushLock biocomposite 2.9 mm knotless)|Arthroscopic repair of the labral lesion with knotless anchors (PushLock biocomposite 2.9 mm knotless)
16048571|NCT02535572|Device|FEAST|FEAST is a new form of ECT, with directional current, rather than traditional alternating current which goes in both directions between the electrodes.
16048572|NCT02535572|Device|RUL UB|This is right unilateral ultrabrief ECT, the standard of care.
16048573|NCT02535559|Behavioral|Teens Against Tobacco Use|Teens Against Tobacco Use teen teachers develop and then deliver anti-tobacco presentations to the target population of younger students.
16048574|NCT02535533|Drug|Selenomethionine (SLM)|SLM administrated orally twice daily for 14 days followed by SLM once daily in combination with Axitinib 5 mg twice daily with titration according to package insert
16048575|NCT02535533|Drug|Axitinib|Following SLM administrated orally twice daily for 14 days, SLM once daily in combination with Axitinib 5 mg twice daily with titration according to package insert
16048576|NCT02535533|Drug|Selenomethionine (SLM)|Maximum tolerated dose (MTD) of SLM determined in the Escalation Part 1 (4000 mcg SLM) given orally twice daily for 14 days, followed by SLM once daily in combination with axitinib 5 mg twice daily with titration according to package insert
16048577|NCT02535533|Drug|Axitinib|Following maximum tolerated dose (MTD) of SLM determined in the Escalation Part 1 (4000 mcg SLM) given orally twice daily for 14 days, SLM once daily in combination with axitinib 5 mg twice daily with titration according to package insert
16048578|NCT02535533|Drug|Selenomethionine (SLM)|Pilot Phase - Dosing will begin at dose level 3 (4000, 5000 or 6000 mcg SLM calculated based on patients' BSA). SLM will be given orally twice daily for 14 days
16048579|NCT02535507|Drug|Pyrotinib|Drug: Pyrotinib pyrotinib, single agent, 400mg p.o once daily until disease progressed
16048580|NCT02535494|Other|Extensive training|We have developed a more in-depth education package to help participants better recognize and respond to an opioid overdose.
16048581|NCT02535481|Device|Epidermal grafting|The Cellutome Epidermal Graft Harvesting System will be used to harvest epidermal grafts.
16048582|NCT02535481|Procedure|Split thickness skin grafting|Split thickness skin grafting will be performed as per normal clinical practice.
16048583|NCT02535455|Behavioral|ACES Pilot|This pilot will consist of 5 individual sessions and an innovative bi-directional text message component that uses participant-written positive self-statements informed by the intervention content (e.g., self-compassion, positive self-reappraisal and nonjudgmental acceptance).
16048584|NCT02535429|Other|massage|
16048585|NCT02535416|Drug|ARC-520|
16048586|NCT02535416|Drug|cetirizine|
16048587|NCT02535416|Drug|diphenhydramine|
16048588|NCT02535403|Behavioral|ICBT|
16048589|NCT02535390|Behavioral|Action based cognitive remediation|This is a novel form of cognitive remediation in which participants engage in simulated real world tasks in groups and receive therapist feedback in addition to receiving standard cognitive remediation.
16048590|NCT02535390|Behavioral|Cognitive remediation|Cognitive remediation engages participants in computerized exercises meant to improve cognitive functions and provides therapist feedback for how these improvements manifest in everyday life.
16048591|NCT02535377|Other|Sperm cryopreservation|Sperm from the different groups are cryopreserved to evaluate their resistance to preservation.
16048592|NCT02535364|Biological|JCAR015 (CD19-targeted CAR T cells)|"Part A: Following leukapheresis and concurrent with generation of JCAR015, participants received, at the Investigator's discretion, cytoreductive chemotherapy based on the Investigator's choice of regimens and/or supportive care.
~Part B: Participants who were eligible for treatment in Part B received two IV doses of JCAR015 CAR T cells separated by 14 to 28 days. JCAR015 infusion was preceded by lymphodepleting chemotherapy with cyclophosphamide alone or cyclophosphamide + fludarabine."
16048593|NCT02535351|Drug|sunitinib or pazopanib|First-line treatment
16048594|NCT02535351|Procedure|Cytoreductive nephrectomy|Cytoreductive nephrectomy and first-line treatment
16048595|NCT02535338|Drug|Erlotinib Hydrochloride|Given PO
16048596|NCT02535338|Other|Laboratory Biomarker Analysis|Correlative studies
16048597|NCT02535338|Drug|Onalespib Lactate|Given IV
16048598|NCT02535338|Other|Pharmacological Study|Correlative studies
16048599|NCT02535325|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo 3-D conformal RT
16048600|NCT02535325|Drug|Cisplatin|Given IV
16048601|NCT02535325|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16048602|NCT02535325|Drug|Methoxyamine|Given PO
16048603|NCT02535325|Drug|Methoxyamine Hydrochloride|Given PO
16048604|NCT02535325|Drug|Pemetrexed|Given IV
16048605|NCT02535325|Drug|Pemetrexed Disodium|Given IV
16048606|NCT02535312|Drug|Cisplatin|Given IV
16048607|NCT02535312|Drug|Methoxyamine|Given PO
16048608|NCT02535312|Drug|Pemetrexed Disodium|Given IV
16048609|NCT02535299|Drug|Liraglutide|GLP-1 analog (1.2mg-1.8mg/day) treatment for 6 months
16048610|NCT02535299|Drug|Metformin|Metformin(1500mg-2000mg/day) treatment for 6 months
16048611|NCT02535286|Drug|Umbralisib|A once daily oral agent
16048612|NCT02535286|Biological|ublituximab|IV anti-CD20 monoclonal antibody
16048613|NCT02535286|Biological|TG-1501|IV immunotherapy for cancer
16048614|NCT02535273|Drug|Dexmedetomidine|load dosage：Intravenous injection dexmedetomidine 1 µg/kg，completed within 10 minutes.
16048615|NCT02535273|Drug|Lidocaine|local anesthesia：0.67% lidocaine local anesthesia layer by layer to the periosteum at the puncture site，Establish puncture channel, injection 5ml 0.67% lidocaine into the vertebral body through the catheter, and observe 5-10min before operation
16048616|NCT02535273|Drug|Low-dose Dexmedetomidine|maintenance dose：Intravenous infusion of dexmedetomidine 0.3 μg/kg/min until the end of surgery
16048617|NCT02535273|Drug|Moderate-dose Dexmedetomidine|maintenance dose：Intravenous infusion of dexmedetomidine 0.5 μg/kg/min until the end of surgery
16048618|NCT02535273|Drug|High-dose Dexmedetomidine|maintenance dose：Intravenous infusion of dexmedetomidine 0.7 μg/kg/min until the end of surgery
16048619|NCT02535273|Drug|normal saline|Intravenous injection normal saline equal quantity，completed within 10 minutes. Intravenous infusion of normal saline 0.125 μg/kg/min until the end of surgery
16048620|NCT02535247|Drug|MK-3475|
16048621|NCT02535247|Drug|Copanlisib|
16048622|NCT02535234|Device|Novel System|A Novel full Continuous Positive Airway Pressure (CPAP) system - Prototype Device, Mask + Accessories
16048623|NCT02535234|Device|Traditional System|A Traditional full Continuous Positive Airway Pressure (CPAP) system- Released Device + Accessories, Prototype Mask
16048624|NCT02535221|Drug|Goserelin+TAM+AI|Goserelin 3.6mg subcutaneous injection per 4 weeks, for 16-20weeks. TAM 10mg oral twice a day for the first four weeks(to wait the Goserelin start to work in body) than change to AI 1mg oral once a day with Goserelin for the next 12-16 weeks.
16048625|NCT02535221|Drug|Epirubicin+CTX+5-Fu|Epirubicin(80-100 mg/m2 Q21 days) + CTX(600 mg/m2 Q 21days) + 5-Fu (600 mg/m2 Q21 days or 200 mg/m2 •day from Day1 to day 21) for four to six cycles.
16048626|NCT02535208|Other|Restrictive transfusions based on SCOR assessment|RBC transfusions will be given to subjects either when participants' Hgb levels fall below defined values based on respiratory status or, despite not having reached their Hgb trigger threshold, if they manifest symptoms judged by the clinical care team to be consistent with anemia (i.e. apnea, bradycardia, or desaturation episodes) and subsequently have a NIRS evaluation that demonstrates an SCOR < 0.73.
16048627|NCT02535208|Other|Liberal transfusions|In the liberal group, RBC transfusions will be given to participants when their Hgb level falls below defined values that are based on respiratory support status, as is standard practice.
16048628|NCT02535195|Dietary Supplement|Ginger supplement|
16048629|NCT02535195|Dietary Supplement|Placebo (starch)|
16048630|NCT02535182|Other|Blood Draw|"Lab will draw one tube of blood to be stored in 8 mL Becton Dickinson (BD) Vacutainer Cell Preparation Tube (CPT) tubes at three study time points as described in Table 4.7b. These time points include baseline, Day -2 (immediately prior to transplant, central line placement, or administration of any conditioning regimen), and Day +28.
~Peripheral blood mononuclear cells (PBMCs) will be isolated from the whole blood samples collected from patients at the three designated time points (Baseline, Day -2, and Day +28). The lab will conduct western blotting on the cytosolic and membrane fractions of isolated PBMCs to determine the distribution of Rap1 in the different fractions, and the status of Rap1 prenylation in the cells."
16048631|NCT02535169|Behavioral|Health Education and Coaching Strategy|Utilizing health education and health coaching to intervene with adolescents who are at high risk for type 2 diabetes or prediabetes regarding nutrition and physical activity. A 16-week curriculum will be utilized and phone-based coaching visits will be performed.
16048632|NCT02535169|Behavioral|Dietary consult|A routine clinic-based dietary consult will be performed (approximately 1-hour).
16048633|NCT02535156|Drug|Risperidone|1 mg Risperidone
16048634|NCT02535156|Drug|Placebo|Lactose Placebo
16048635|NCT02535143|Other|Test Cavity Preparation|Subjects will be asked to prepare a cavity 2mmx 2mmx 2mm in an acrylic block using an airotor and a tungsten carbide bur prior to consuming the test drink
16048636|NCT02535143|Drug|Taurine|250 ml of commercially available taurine containing energy drink to be administered three hours after the last meal and half an hour prior to performing the second test cavity
16048683|NCT02534701|Device|ERIC® and SOFIA™|a self-expanding clot retrieval system
16048684|NCT02534688|Drug|LNG-IUS|
16048685|NCT02534688|Drug|DMPA|
16048637|NCT02535143|Other|Post intervention test cavity|Subjects will be asked to prepare a cavity 2mmx 2mmx 2mm in an acrylic block 30 minutes after consuming the intervention drink using an airotor and a tungsten carbide bur prior to consuming the test drink
16048638|NCT02535143|Dietary Supplement|Carbonated Apple Juice|250ml of commercially available carbonated apple juice to be administered three hours after the last meal and half an hour prior to performing the second test cavity
16048639|NCT02535130|Device|Positive expiratory pressure|
16048640|NCT02535130|Drug|amikacine nebulization|
16048641|NCT02535117|Procedure|Laparoscopic Surgery(LS)|For LS, the patient was usually placed in the lithotomy position. Pneumoperitoneum was maintained at a pressure between 12 and 14 mmHg. Three to 4 working ports sized between 5 mm and 12 mm were used . Intra-operative ultrasonography was performed routinely. Parenchymal transection was performed using a Cavitron ultrasonic surgical aspirator (CUSA, Valleylab, Boulder, CO, USA). Large bile duct branches or vessels were clipped before division and minor hemostasis was carried out using bipolar diathermy. Large hepatic vein branches were divided by endovascular staplers. A 1.0-cm safety margin was planed to get during the liver resection.
16048642|NCT02535117|Procedure|RFA|RFA was performed according to the Guidelines of Radiofrequency Ablation Therapy for Liver Cancer: Chinese Expert Consensus Statement issued by the Chinese Society of Liver Cancer and Chinese Society of Clinical Oncology RFA was performed under real-time ultrasound guidance. RFA was performed by using a commercially available Cool-tipTM RFA system (Valleylab, Boulder, CO, USA), or a RF 2000 system (Radio-Therapeutics Mountain View, CA). Grounding was achieved by attaching 2 pads to the patient's back or legs.
16048643|NCT02535104|Drug|Ranpirnase|Topical application by subject
16048644|NCT02535104|Drug|Vehicle|Vehicle control
16048645|NCT02535091|Drug|YKP3089|see above
16048646|NCT02535078|Drug|IMCgp100|soluble gp100-specific T cell receptor with anti-CD3 scFV
16048647|NCT02535078|Drug|durvalumab|anti-PD-L1 monoclonal antibody
16048648|NCT02535078|Drug|tremelimumab|anti-CTLA-4 monoclonal antibody
16048649|NCT02535065|Device|Zenith Low Profile AAA Endovascular Graft and ancillary components|Treatment of patients with abdominal aortic, aortoiliac, or iliac aneurysms having morphology suitable for endovascular repair
16048650|NCT02535052|Biological|Seasonal influenza and pneumococcal polysaccharide vaccines|Vaccination
16048651|NCT02535039|Drug|Methylprednisolone|Anaesthesia in giving 1 mg/kg intravenous methylprednisolone, methylprednisolone (1 mg/kg * d for application to the third day after surgery
16048652|NCT02535039|Other|Physiological saline|The same volume of physiological saline will be given in Placebo group
16048653|NCT02535013|Device|Lung ultrasound|Lung ultrasound with appropriate interventions depending on the ultrasound finding
16048654|NCT02535000|Drug|Duloxetine|duloxetine 60 mg
16048655|NCT02535000|Drug|Placebo|placebo
16048656|NCT02534987|Other|iCPR2|clinical decision support guiding clinician through clinical prediction rule and associated evidence based orders for strep and pneumonia
16048657|NCT02534974|Device|NOSTEN|
16048658|NCT02534961|Drug|Cefazolin|Patients in the prophylactic group will receive antibiotic treatment right after randomization with intravenous cefazolin 2 g (3 g for patients weighing ≥120 kg) within 60 minutes before ablation therapy. Patients in the on-demand group will receive antibiotic therapy only when infection will be suspected or established. Antibiotics will be changed according to the antibiotic sensitivity test of cultured microorganisms.
16048659|NCT02534948|Behavioral|Mindfulness and acceptance group therapy|The manual group intervention will be provided as per the second edition of Mindfulness and Acceptance-Based Group Therapy for Social Anxiety Disorder: A Treatment Manual developed by Fleming, and Kocovski (2014). The intervention will consist of 10 group therapy sessions. Each session will be conducted in 120 minutes. It includes therapist manual, client handouts, and is written to be used in conjunction with The Mindfulness and Acceptance Workbook for Social Anxiety and Shyness. The treatment manual can be easily adapted for individual therapy clients.
16048660|NCT02534935|Biological|rLP2086 vaccine|60 mcg or 120mcg at 0, 2 and 6 months
16048661|NCT02534935|Biological|Pediatric HAV vaccine|0.5-mL dose at months 0 and 6. Normal saline at month 2.
16048662|NCT02534922|Biological|Prolanta, a human prolactin receptor antagonist|Daily subcutaneous dosing
16048663|NCT02534909|Biological|LFG316|LFG316 will be administered to all patients enrolled in the study
16048664|NCT02534896|Drug|Treatment I|Sunpharma1505 and Placebo
16048665|NCT02534896|Drug|Treatment II|Sunpharma1505 and Placebo
16048666|NCT02534896|Drug|Treatment III|Reference1505 and Placebo
16048667|NCT02534883|Drug|Misoprostol|To be place vaginally
16048668|NCT02534883|Drug|Placebo|To be placed vaginally
16048669|NCT02534870|Drug|ABT-450/r/ABT-267|Tablet
16048670|NCT02534870|Drug|ABT-333|Tablet
16048671|NCT02534857|Procedure|a shorter exposure of oocyte to spermatozoa|Shorter exposure of oocyte to spermatozoa group: oocytes will be exposed to spermatozoa for 2 hours
16048672|NCT02534844|Drug|Parts A/B: Adrabetadex|900 - 1800 milligram (mg) of adrabetadex administered every 2 weeks via lumbar intrathecal infusion
16048673|NCT02534844|Other|Parts A/B: Sham Control|No experimental drug is administered to patients - intrathecal administrations are simulated by skin prick
16048674|NCT02534831|Procedure|Soft tissue manual therapy protocol|The STMTP consisted of a pre-determined set of seven (7) soft tissue techniques delivered as part of a single treatment session lasting approximately 30 minutes. The techniques and their respective durations were: suboccipital release (5 minutes), anterior thoracic myofascial and sternum release (5 minutes), anterior cervical myofascial release (5 minutes), costal ligament balance (5 minutes) and muscular energy technique (MET) to the following muscles - scalenes (1 minute and 40 seconds), pectoralis minor (1 minute and 40 seconds) and latissimus dorsi and serratus anterior (1 minute and 40 seconds)
16048675|NCT02534818|Drug|lower fluorescein sodium dosage 0.02ml/kg|fluorescein Sodium Dose of 0.02ml/kg on gastric intestinal metapalsia
16048676|NCT02534818|Drug|conventional fluorescein sodium dosage 0.1ml/kg|fluorescein Sodium Dose of 0.1ml/kg on gastric intestinal metapalsia
16048677|NCT02534792|Other|Revalvulation|
16048678|NCT02534779|Other|Placebo Vaginal Insert|Placebo insert
16048679|NCT02534753|Drug|Ascor L 500® (Ascorbic Acid Injection, USP)|A sterile, solution containing 500 mg ascorbic acid per mL
16048680|NCT02534740|Drug|tafamidis|relative bioavailability
16048686|NCT02534662|Device|ENDOMINA|Endomina will be introduced into the stomach over guide wires and then fixed to the endoscope. The procedure will include the placement of 4-6 transmural anterior-posterior sutures after argon plasma coagulation of the tissue opposition areas in order to ensure persistence of the pouch reduction. Patient will be kept overnight after the procedure.
16048687|NCT02534649|Procedure|Newly obtained biopsy and Blood samples collection|"For each patient:
~Frozen and paraffin embedded tumor material (archival or new biopsy) will be obtained for genetic profiling
~Four blood samples will be obtained for genetic profiling and assessment of markers The results of each tumor profile will be discussed within a multidisciplinary tumor board which aims at discussing the genomic profiles and at providing a therapeutic decision for each patient.
~Patients for whom no molecular aberration has been identified will be treated at the discretion of the investigator and followed until death or study termination whichever occurs first.
~All the patients carrying a molecular aberration will be proposed to enter in a clinical trial depending on the possibility of inclusion at the time of molecular report."
16048688|NCT02534636|Drug|BMS-986165|
16048689|NCT02534636|Drug|Interferon alpha-2a recombinant|
16048690|NCT02534636|Drug|Famotidine|
16048691|NCT02534636|Other|Placebo|
16048692|NCT02534623|Procedure|Spinal anesthesia|
16048693|NCT02534623|Procedure|General anesthesia|
16048694|NCT02534623|Drug|bupivacaine|
16048695|NCT02534623|Drug|fentanyl|
16048696|NCT02534623|Drug|propofol|
16048697|NCT02534623|Drug|sevoflurane|
16048698|NCT02534610|Drug|Etoricoxib|120 mg etoricoxib PO administered 1 h preoperative for group A; group B received 120 mg etoricoxib PO at the end of the surgery.
16048699|NCT02534610|Drug|Placebo|Group A received 1 sham pill PO at the end of the surgery; group B received 1 sham pill PO 1 h preoperative and group C received sham pill PO 1 h preoperative and 1 sham pill PO at the end of the surgery.
16048700|NCT02534597|Behavioral|Promotores Training|
16048701|NCT02534597|Behavioral|Delayed Promotores training|
16048702|NCT02534597|Behavioral|Caregiver training|
16048703|NCT02534597|Behavioral|Delayed caregiver training|
16048704|NCT02534597|Behavioral|Materials support|
16048705|NCT02534597|Behavioral|Delayed materials support|
16048706|NCT02534597|Behavioral|Technical assistance|
16048707|NCT02534597|Behavioral|Delayed technical assistance|
16048708|NCT02534571|Device|Endoscopic Application of a Hemostatic Powder TC-325|Endoscopic Application of a Hemostatic Powder TC-325 <=150g once
16048709|NCT02534571|Device|Hemo-clipping|Hemo-clipping <=20 clips
16048710|NCT02534571|Drug|Epinephrine|epinephrine injection endoscopically <20 mls
16048711|NCT02534571|Device|thermo-coagulation|contact thermo-coagulation < = 4 pulses
16048712|NCT02534558|Biological|miR 29a|Effects of IL-1β, miR-29a precursor or antisense oligonucleotide treatment on the expressions of miR-29a, miR-29b or miR-29c in cell cultures are quantified
16048713|NCT02534545|Device|Doctormate® (200mmHg)|Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 200mmHg.
16048714|NCT02534545|Device|Doctormate® (60mmHg)|Limb ischemia was induced by Renqiao Remote Ischemic Conditioning Device (Doctormate®) inflating tourniquets to 60mmHg.
16048715|NCT02534532|Other|AF screening|Screening of AF in an opportunistic screening program using a smartphone device/application confirmed by ECG
16048716|NCT02534519|Other|Whole Genome Sequencing (WGS)|There will be no interventions needed other than blood sampling (20 mL blood) in the course of routine blood donation (450 mL blood) for 8 out of 10 individuals planned to be included as specimen, or reference samples in the study.
16048717|NCT02534506|Drug|Urelumab|
16048718|NCT02534506|Drug|Nivolumab|
16048719|NCT02534493|Device|Carpal Tunnel Tissue Manipulation Device (CTMD)|This piece of rigid, shaped, biocompatible plastic (polypropylene) rated for skin contact and a strong but safe hypoallergenic biocompatible medical adhesive which bonds the skin over the carpal tunnel to the plastic piece for a duration of 2-14 hours.
16048720|NCT02534480|Drug|NGP 555|Gamma-secretase modulator for the treatment of Alzheimer's disease
16048721|NCT02534467|Drug|Montelukast|daily dose according to age for 8 weeks out of 16 weeks of assessment
16048722|NCT02534454|Behavioral|Active Retraining|
16048723|NCT02534454|Behavioral|Sham Retraining|
16048724|NCT02534454|Device|Active transcranial direct current stimulation (TDCS)|
16048725|NCT02534454|Device|Sham transcranial direct current stimulation (TDCS)|
16048726|NCT02534454|Drug|Nicotine Replacement Therapy (Habitrol)|Administration of Nicotine Replacement Therapy Patches
16048727|NCT02534441|Other|Skin patch test|
16048728|NCT02534428|Other|wool clothing|superfine merino wool ensembles for baby wear
16048729|NCT02534415|Drug|Periodontal dressing material|Procedure:Palatal wound area was covered with periodontal dressing material at baseline and 3rd day
16048730|NCT02534415|Drug|0.2% Hyaluronic acid gel|0.2% topical hyaluronic-acid gel was applied to palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day
16048731|NCT02534415|Drug|0.8% Hyaluronic acid gel|0.8% topical hyaluronic-acid gel was applied palatal wound area and covered with periodontal dressing material (Peripac®) at baseline and 3rd day
16048732|NCT02534402|Drug|Prednisone|Administration of prednisone to determine the effect on whole blood gene expression.
16048733|NCT02534389|Dietary Supplement|omega-3 fish oil|2,4g of EPA + DHA
16048734|NCT02534376|Drug|ezetimibe 10mg-simvastatin 40mg|Vytorin (ezetimibe 10mg-simvastatin 40mg) will be given on an outpatient basis. The drug will be taken orally each day until the subject undergoes radical prostatectomy. The start of Vytorin is timed so that patients get the last dose the day before surgery. Subjects receive a two to four weeks of Vytorin.
16048735|NCT02534363|Drug|Aripiprazole|Oral, dose range 5-30 mg/day, once or twice a day, during study duration
16048736|NCT02534363|Drug|Quetiapine|Oral, dose range 100-600 mg/day, once or twice a day, during study duration
16048737|NCT02534363|Drug|Ziprasidone|Oral, dose range 40-160 mg/day, once or twice a day, during study duration
16048809|NCT02533726|Other|Patient Sensor|A small sensor with adhesive backing is applied to the upper chest (midline) of the patient. Sensor tracks and records body movement and position, and displays this on a User Dashboard located on a computer at the bedside.
16048738|NCT02534363|Behavioral|Cognitive battery|Completed in the following standardized sequence: 1-the Rey Auditory Verbal Learning Test (RAVLT); 2-WAIS-III digit symbol subtest; 3-Grooved Pegboard Test; 4-The Zoo Map Test; 5-Tower of London Test (ToL); 6-Rey Complex Figure (RCF); 7-Trail Making Test (TMT); 8-WAIS-III digits forward and backward subtests; 9-WAIS-III letter-number sequencing subtest; 10-WAIS-III vocabulary subtest that was used as measure of premorbid intelligence quotient (IQ); 11-Stroop Test; 12-letter (FAS) and semantic (animal) fluency tests; 14-Eyes Task; 15-Continuous Performance Test (CPT).
16048739|NCT02534350|Drug|Presatovir|Tablets administered orally or via nasogastric (NG) tube once daily
16048740|NCT02534350|Drug|Placebo|Tablets administered orally or via NG tube once daily
16048741|NCT02534337|Drug|GEMOX|gemcitabine 1000mg/m2 on Day 1 and oxaliplatin 100 mg/m2 on Day 2. The treatment was repeated every 2 weeks until disease progression or limiting toxicity.
16048742|NCT02534337|Drug|FOLFOX4|Oxaliplatin 85 mg/m2 intravenously on day 1;Leucovorin 200 mg/m2 IV(in vein) from hour 0 to 2 on days 1 and 2; and Fluorouracil 400 mg/m2 IV bolus at hour 2, then 600mg/m2 over 22 hours on days 1 and 2, once every 2 weeks until progression or unacceptable toxicity develops or Progressive Disease.
16048743|NCT02534324|Drug|Antihypertensive meds|Antihypertensive medications will be given to newly-diagnosed or non-compliant cases. The additional oral antihypertensive drugs instruction to adjust their current regimens will be given to the patients with underlying hypertension for more BP control. The choices of drugs will be at discretion of treating physicians.
16048744|NCT02534311|Drug|Tocilizumab|Tocilizumab will be administered at 162 mg SC injection for 48 weeks.
16048745|NCT02534298|Other|functional magnetic resonance imaging|functional magnetic resonance imaging
16048746|NCT02534285|Device|hearing protection|Attenuation of hearing during surgery
16048747|NCT02534272|Other|Stool sampling and sequencing of gut microbiota.|
16048748|NCT02534259|Other|Force monitoring of external fixator struts|
16048749|NCT02534246|Device|Ultrasound biopsy needle Echo Tip ProCore|Two passes preformed with Echo Tip ProCore ultrasound biopsy needle (Cook Medical 25 gauge) and two passes will be performed using SharkCore ultrasound biopsy needle (Medtronic [Beacon] 25 gauge) from single lesion.
16048750|NCT02534246|Device|Ultrasound biopsy needle SharkCore|
16048751|NCT02534233|Device|CryoBalloon|Esophageal tissue ablation with focal freezing using nitrous oxide via a single use balloon catheter
16048752|NCT02534220|Device|Manual Toothbrush|Gum Delicate Post-Surgical Toothbrush, Oral-B, Procter & Gamble, Cincinnati, OH
16048753|NCT02534220|Device|Oscillating-rotating toothbrush|Triumph 5000, Oral-B, Procter & Gamble, Cincinnati, OH
16048754|NCT02534207|Drug|Basmisanil|Single oral dose: Basmisanil doses between 20 milligrams (mg) and 960 mg may be used in this study. The planned doses for the first two participants are 160 mg and 480 mg, respectively. Basmisanil dose for subsequent participants will be decided by the investigator and sponsor during the study, based on on-going review of emerging data.
16048755|NCT02534194|Other|Image acquisition|Images of baby's face (including ear) and feet
16048756|NCT02534181|Drug|Caloric Management Protocol|Strategy based on reduction of nutritional intake and electrolyte replacement.
16048757|NCT02534168|Device|Skin conductance monitor for measuring skin conductance|"The Skin conductance monitor for measuring skin conductance on the palm of the hand or sole of the foot in microSiemens (µS); it then calculates the number of skin conductance responses per second and the area under the registration curve.
~The device records sympathetic autonomous nervous system through its effect on skin.
~The device (Med-Storm Innovation AS, Gimle Terrasse 4, NO-0264 Oslo, Norway, support@med-storm.com) includes cables, skin electrodes, a measurement unit and a monitor."
16048758|NCT02534155|Device|MitraClip®|one or more (if needed) MitraClip® devices are placed on the leaflets of the mitral valve during catheterisation in a catheter laboratory
16048759|NCT02534155|Procedure|Mitral valve Surgery|Repair or replace mitral valve
16048760|NCT02534129|Drug|Difinsa53|Difinsa53 cream is applied to one half of radiation field
16048761|NCT02534129|Drug|Aquaphor|Aquaphor is applied to one half of radiation field
16048762|NCT02534116|Procedure|Vacuum-assisted closure (VAC) therapy|Following closure of the incision, patients will either have a gauze dressing placed over the incision (control group), or incisional vacuum-assisted closure (VAC) therapy. The dressing will be removed over a time period of 2 to 5 days after surgery. The gauze dressing will be removed at 2 days and the wound VAC will be removed at 5 days.
16048763|NCT02534116|Procedure|Gauze dressing|Following closure of the incision, patients will either have a gauze dressing placed over the incision (control group), or incisional vacuum-assisted closure (VAC) therapy. The dressing will be removed over a time period of 2 to 5 days after surgery. The gauze dressing will be removed at 2 days and the wound VAC will be removed at 5 days.
16048764|NCT02534077|Drug|Omegaven|Therapy with Omegaven will be provided at a dose of 1 gm/kg/day (by continuous infusion). Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition.
16048765|NCT02534077|Drug|Omegaven|Treatment will be given for as long as the child needs any TPN AND has a conjugated bilirubin greater than 2 mg/dL for a maximum of 2 years.
16048766|NCT02534077|Drug|Omegaven|If the bilirubin is less than 2 mg/dL but the child still requires TPN, then the Omegaven will be continued until the infant no longer requires TPN.
16048767|NCT02534064|Dietary Supplement|CALIN+|Consumption of 2 CALIN+ pots per day during 16 weeks and follow up without product intake during 8 weeks.
16048768|NCT02534064|Dietary Supplement|CALIN+|Consumption of 1 CALIN+ pot per day during 16 weeks and follow up without product intake during 8 weeks.
16048769|NCT02534051|Other|Clinical Care Pathway|The clinical care pathway guides aspects of care specific to obese pregnant women:1st trimester: offer of testing for pre-existing diabetes with either 75g OGTT or 50g GCT, nuchal translucency ultrasound (u/s), calculation of body mass index, counselling about weight gain, advising about medical complications, screening for obstructive sleep apnea, and referral to Maternal-Fetal Medicine if history of bariatric surgery, 2nd trimester: offer of maternal-serum alpha fetal protein (spina bifida), anatomy u/s, and 50g GCT and 75g OGTT, 3rd trimester: offer of consultation with anesthesiology, u/s for growth & well-being, counselling about birth risks, and discussion of breastfeeding.
16048770|NCT02534038|Drug|AVP-786|d6-DM/Q
16048771|NCT02534038|Drug|Placebo|matching placebo
16048772|NCT02534025|Procedure|Ischemia preconditioining|Elavate blood pressure cuff pressure to 200
16048773|NCT02534012|Drug|Paravertebral block|Bilateral nerve stimulator-guided PVB is performed while patients are in lateral decubitis position. An intervertebral line is drawn at the appropriate levels and the injection site is marked 2.5 cm lateral to the midline on both sides. After aseptic preparation of the skin, 0.3 mL 2% lidocaine is infiltrated at the injection sites. A 22-G nerve stimulation needle (Stimuplex, B.Braun, Melsungen, Germany) is advanced 1-2 cm perpendicularly to the skin using a nerve stimulating current of 2.5-5.0 mA, while closely watching for contractions of the abdominal muscles. The tip of the needle is adjusted to continue to produce muscle contractions while reducing the stimulating current to approximately 0.5-0.6 mA. Depending on patient weight, 3-5 mL of the local anaesthetic mixture is injected at each injection site.
16048774|NCT02534012|Drug|General anesthesia|Anesthesia is induced with 1 µg/kg fentanyl, 1.5-2 mg/kg propofol and 1-2 mg midazolam. Then, endotracheal intubation is facilitated by 0.15 mg nimbex (cisatracurium). Anesthesia is maintained by 1-1.5% sevoflurane, 0.5 µg/kg/h fentanyl, 0.05 mg/kg/h nimbex, 60% nitrous oxide and 40% oxygen.
16048775|NCT02534012|Procedure|Major abdominal surgery|
16048776|NCT02533999|Device|PEAK® Plasma System|Surgical method for tonsillectomy and adenoidectomy.
16048777|NCT02533999|Device|Electrosurgery|Surgical method for tonsillectomy and adenoidectomy.
16048778|NCT02533986|Dietary Supplement|Berry peel drink|
16048779|NCT02533986|Dietary Supplement|Control drink|
16048780|NCT02533973|Drug|Xamiol® gel|
16048781|NCT02533973|Drug|Daivonex® scalp solution|
16048782|NCT02533960|Other|not applicable (observational study)|Observational study without study related intervention.
16048783|NCT02533947|Behavioral|Exercise|The intervention consists of an individually tailored supervised exercise program with aerobic, strength and coordinative components.
16048784|NCT02533947|Behavioral|Control|A waitlist control group will get the intervention after 7 month of treatment as usual.
16048785|NCT02533934|Drug|Harvoni|Treatment of Hepatitis C with sofosbuvir based HCC therapy
16048786|NCT02533921|Other|Interdisciplinary outpatient palliative care|Interdisciplinary outpatient palliative care is an approach to caring for individuals with life-threatening illnesses that addresses potential causes of suffering including physical symptoms such as pain, psychiatric symptoms such as depression, psychosocial issues and spiritual needs. Palliative care approaches have been successfully applied to improve patient-centered outcomes in cancer as well as several chronic progressive illnesses including heart failure and pulmonary disease.
16048787|NCT02533921|Other|Standard of Care|Usual care defined as including both a PCP and neurologist
16048788|NCT02533908|Drug|Fentanyl intranasal|fentanyl is applied intranasally with a MAD (mucosal atomization device) prior to the application of nitrous oxide 70% analgosedation
16048789|NCT02533908|Drug|NaCl 0.9% intranasal|Placebo is applied intranasally with a MAD (mucosal atomization device) Prior to the application of nitrous oxide 70% analgosedation
16048790|NCT02533895|Biological|AV0113 DC-CIT|Mature loaded DCs will be injected intra-nodally into tumour free lymph nodes or subcutaneously close to tumour free lymph nodes at weekly intervals for at least 6 weeks.
16048791|NCT02533895|Other|Data evaluation|"For obtaining a clearer picture of AV0113's utility in the treatment of bone and soft tissue sarcoma, a LT follow-up investigation of the 14 Sarcoma patients, which will be treated using the AV0113 DC-CIT technology, is planned, in order to gather first evidence for a potential LT effect of DC-CIT with AV0113.
~Furthermore, a comparison of the 14 sarcoma patients treated with AV0113 DC-CIT with a cohort of matched historic control patients that were treated using standard of care will be conducted. It is planned to analyse 42 control sarcoma patients that will be matched for disease, recurrences, relapses etc"
16048792|NCT02533882|Behavioral|Movement to Music|
16048793|NCT02533882|Behavioral|Adapted Yoga|
16048794|NCT02533869|Radiation|Low-dose CT|Low-dose computed tomography for suspected acute uncomplicated appendicitis
16048795|NCT02533869|Procedure|Laparoscopic appendectomy|All patients diagnosed with an uncomplicated acute appendicitis on low-dose CT-scan will undergo laparoscopic appendectomy to evaluate the sensitivity and specificity of the CT diagnosis
16048796|NCT02533856|Other|ETOC|Services provided to assist patients in accessing needed healthcare services after emergency department discharge such as scheduling appointments, finding new doctors, getting medications, or addressing problems with insurance coverage.
16048797|NCT02533843|Procedure|radiofrequency catheter ablation|Radiofrequency catheter ablation of atrial fibrillation with or without being guided by FIRMap (using RhythmView™ Workstation from TOPERA)
16048798|NCT02533830|Biological|sugarless gum|"One Stick of Sugarless Gum (Samara for food & Chocolates Product Company)S.A.E. , for 15 Minutes Every 2 hours After Surgery Tell Defecation"
16048799|NCT02533830|Other|traditional management|Traditional Management (Oral Intake of Clear Fluid Allowed After Passage of Flatus and Regular Diet With The Passage of Bowel Movement.
16048800|NCT02533817|Dietary Supplement|Dietary sugar|This study examined the effect of high intakes of fructose compared to high intakes of glucose in a randomized crossover design. The treatment was in replacement of 20% of the daily caloric requirements for either fructose or glucose for each individual.
16048801|NCT02533791|Biological|4×10^10vp/1ml Ebola Zaire vaccine (Ad5-EBOV)|one dose, 4×10^10vp/1ml per dose
16048802|NCT02533791|Biological|1.6×10^11vp/2ml Ebola Zaire vaccine (Ad5-EBOV)|two doses, 0.8×10^11vp/1ml per dose, with one dose to each arm at the same time
16048803|NCT02533791|Biological|placebo|
16048804|NCT02533778|Device|mechanical thrombectomy|Mechanical thrombectomy by either Penumbra system, TREVO, or Solitaire retrieval device
16048805|NCT02533765|Drug|Olaparib|Olaparib dispensed to patients at the dose of 300 mg twice daily (BID) continuously until the patient completes the study, withdraws from the study or closure of the study.
16048806|NCT02533739|Behavioral|Cognitive and neuropsychological assesment|
16048807|NCT02533726|Other|Optimal Turning|Patients within this arm will receive optimal turning practices. Nurses caring for these patients will receive real-time quantitative measures of patient turning procedures from the User Dashboard and provide a visual advisory to the nurse for the time to next turn.
16048808|NCT02533726|Other|Standard Care Practices|Patients within this arm will receive standard preventative care practices - that is, nurses will provide standard care as necessary, without the aid of visual advisories from a patient sensor.
16049042|NCT02532049|Biological|MVA Pfs25-IMX313|
16048810|NCT02533713|Device|Exoskeleton assisted gait training|Gait training will be performed 3 times a week for about an hour for 26 weeks. Gait training will be performed by a trained clinical physical therapist. The goal is to achieve 1 hour of continuous walking on a flat surface per training session. Gait training will continue for 26 weeks (78 sessions).
16048811|NCT02533700|Drug|CEOP/IVE/GDP chemotherapy regimen|"CEOP:
~Cyclophosphamide 750mg/m2, ivgtt D1 Epirubucin 70mg/m2,ivgtt D1 Vincristine 1.4mg/m2（max 2mg）, ivgtt D1 Prednisone 60mg/m2 （max 100mg）,PO,D1-D5
~IVE:
~Ifosfamide 2000mg/m2,ivgtt D1-D3 Epirubucin 70mg/m2, ivgtt D1 Etoposide 100mg/m2, ivgtt D1-D3
~GDP:
~Gemcitabine 1g/m2,ivgtt D1,D8 Cis-platinum 25mg/m2, ivgtt D1-D3 Dexamethasone 40mg, ivgtt D1-D4"
16048812|NCT02533700|Drug|CEOP chemotherapy regimen for 6 cycles|"CEOP:
~Cyclophosphamide 750mg/m2, ivgtt D1 Epirubucin 70mg/m2,ivgtt D1 Vincristine 1.4mg/m2（max 2mg）, ivgtt D1 Prednisone 60mg/m2 （max 100mg）,PO,D1-D5 every 21 days for total 6 courses"
16048813|NCT02533687|Procedure|Bipolar TURP-1|Bipolar transurethral resection of prostate (TURP)
16048814|NCT02533687|Procedure|Bipolar TURP-2|Bipolar TURP
16048815|NCT02533687|Procedure|Monopolar TURP|Monopolar TURP
16048816|NCT02533674|Drug|Gemcitabine plus PM060184|
16048817|NCT02533661|Other|Family-centered intervention program|This program will include in-hospital intervention, after-discharge intervention and neonatal follow-up. Five sessions of in-hospital intervention will emphasize modulation of the NICU, teaching of child developmental skills, feeding support, massage, interactional activities and parent support and education. The 7-session after-discharge intervention will consist of 4 clinic visits and 3 home visits with specific care in modulation of home environment, teaching of child developmental skills, feeding support, teaching of interactional activities, and parent support and education
16048818|NCT02533648|Drug|2 capsules of allopurinol 150 mg daily for 3 month|2 capsules of allopurinol 150 mg daily for 3 month
16048819|NCT02533648|Drug|2 capsules of lactose daily for 3 month|2 capsules of lactose daily for 3 month
16048820|NCT02533635|Dietary Supplement|A Master Ganoderma Detox Tea|A Master Ganoderma Detox Tea is consisted of GANODERMA, HERBA HOUTTUYNIAE, GLYCYRRHIZAE RADIX ET RHIZOMA and RUCTUS MOMORDICAE.
16048821|NCT02533583|Device|pulse oximetry (PHILIPS intelliven MP5)|all newborn monitor pulse oximetry in left hand
16048822|NCT02533570|Drug|Brentuximab vedotin|
16048823|NCT02533570|Drug|Placebo|
16048824|NCT02533557|Device|stimuplex insulated needle|"2P2I group: nerve stimulating needle is advanced twice with the up-down direction at the different puncture site and LA is injected 15 mL at a time.
~1P2I group: nerve stimulating needle is advanced twice with the up-down direction at the same puncture site and LA is injected 15 mL at a time."
16048825|NCT02533557|Drug|lidocaine mixed with epinephrine|2P2I group and 1P2I group use the same LA (1.5% lidocaine mixed with 1:200,000 epinephrine). But 2P2I group is injected LA at equally divided doses (15 mL at a time) with the up-down direction at the different puncture site. 1P2I group is injected LA at equally divided doses with the up-down direction at the same puncture site.
16048826|NCT02533544|Drug|tenofovir disoproxil fumarate|
16048827|NCT02533531|Device|1-Lead Patch|The 1-Lead Patch will record and transmit ECG data to a gateway, which will then transmit the data to a central database.
16048828|NCT02533518|Procedure|Rigid bronchoscopy with ultraviolet transmission|
16048829|NCT02533518|Other|Biopsy|
16048830|NCT02533505|Drug|Budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg Inhalation aerosol|Subjects will receive a single dose (2 inhalations) of Symbicort pMDI 160/4.5 μg (2 inhalations; total dosage 320/9.0 μg) or placebo (with a spacer) in a cross-over design (a total of 2 doses of Symbicort and 2 doses of placebo over the duration of the study), and assessments will be made before and after dosing at specified timepoints
16048831|NCT02533505|Drug|Matching Placebo pMDI 160/4.5 μg|Placebo will be given according at the same dose and schedule as the active comparator - cross-over design.
16048832|NCT02533492|Device|vicryl|wound closure with vicryl suture
16048833|NCT02533492|Device|Vicryl plus|wound closure with vicryl plus suture
16048834|NCT02533479|Other|Caloric restriction|three alternate days weekly along 4 weeks.
16048835|NCT02533466|Other|Sodium fluoride + potassium nitrate|Marketed toothpaste containing 1450ppm fluoride as sodium fluoride and 5% potassium nitrate
16048836|NCT02533466|Other|Potassium nitrate|Experimental toothpaste containing 5% potassium nitrate
16048837|NCT02533453|Biological|Bydureon|exenatide once weekly
16048838|NCT02533440|Procedure|EXPAREL and Local Anesthetics|Patients will receive EXPAREL and local anesthetics, as well as opioid and non-opioid analgesics prescription, (only use if needed, for post surgical pain)
16048839|NCT02533440|Procedure|Oral Opioid and Local Anesthetics|Patients will receive local anesthetics, as well as oral opioid or non-opioid analgesics, (only use if needed, for post surgical pain)
16048840|NCT02533427|Drug|SOF/VEL/VOX|400/100/100 mg FDC tablet administered orally once daily
16048841|NCT02533427|Drug|VOX|100 mg tablet administered orally once daily
16048842|NCT02533427|Drug|Norgestimate/ethinyl estradiol|Norgestimate 0.180 mg/0.215 mg/0.25 mg/ethinyl estradiol 0.025 mg tablet administered orally once daily according to the package insert
16048843|NCT02533414|Device|RIRS with UAS|Ureteral access sheath (UAS) will be used during RIRS.
16048844|NCT02533414|Device|RIRS without UAS|Ureteral access sheath will not be used during RIRS.
16048845|NCT02533401|Drug|Cyclophosphamide|Cyclophosphamide will be administered IV at 250 mg/m^2/day on Day 2-4 of Cycle 1 and then on Day 1-3 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length.
16048846|NCT02533401|Drug|Fludarabine|Fludarabine will be administered IV at 25 mg/m^2/day on Day 2-4 of Cycle 1 and then on Day 1-3 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length.
16048847|NCT02533401|Drug|Rituximab|Rituximab will be administered IV at 375 mg/m^2 on Day 1 of Cycle 1 and then at 500 mg/m^2 on Day 1 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length.
16048883|NCT02533141|Drug|Simvastatin|Simvastatin Ranbaxy (Basics GmbH, Leverkusen, Germany) Dosage: 40 mg per day for 4 weeks, ingested in the morning Route of administration: peroral
16048884|NCT02533141|Other|Placebo|Placebo, once daily for 4 weeks
16048885|NCT02533128|Drug|Liberal blood pressure management|Protocolized hemodynamic management to maintain mean arterial pressure (MAP) > 60 mmHg
16048886|NCT02533128|Drug|Tight blood pressure management|Protocolized hemodynamic management to maintain mean arterial pressure (MAP) > 75 mmHg
16048848|NCT02533388|Device|Hwato Electronic Acupuncture Treatment Instrument|Thirty minutes prior to the induction of anaesthesia, the patients in the TEAS group started to receive TEAS by a stimulator (Hwato Electronic Acupuncture Treatment Instrument, model No.: SDZ-II, Suzhou Medical Appliances Co., Ltd., Suzhou, China) to the right hand, forearm and neck by an experienced acupuncturist at the Hegu (LI4), Neiguan (PC6), Lieque (LU7), Chize (LU5), Futu (LI18) and Renying (ST9) acupoints. TEAS was peformed with an alternate dense-disperse frequency of 2 and10 Hz ( 2 Hz for 10 s and 10 Hz for 5 s). The optimal intensity ranged from 6-15 mA, The stimulus continued until 5 min before the end of surgery.
16048849|NCT02533388|Device|Placebo|The patients in the Sham group were also connected to the apparatus, but electronic stimulation was not applied.
16048850|NCT02533375|Drug|Adalimumab|Adalimumab pre-filled syringe, administered by subcutaneous injection
16048851|NCT02533362|Drug|ANF-Rho|Pegylated version of recombinant human granulocyte-colony stimulating factor (G-CSF)
16048852|NCT02533349|Drug|Motilitone|30mg, 1 tablet, 3 times a day
16048853|NCT02533349|Drug|Pantoprazole|40mg, 1 tablet, 1time a day
16048854|NCT02533349|Drug|Placebo|30mg, 1 tablet, 3 times a day
16048855|NCT02533336|Drug|abamectin and fenpyroximate|
16048856|NCT02533323|Drug|gemcitabine|gemcitabine :1250mg/m2 (ivdrip) on days 1
16048857|NCT02533323|Drug|oxaliplatin|oxaliplatin :85 mg/m2 (ivdrip) on day 1
16048858|NCT02533323|Drug|pegaspargase|pegaspargase : 2500 IU/m2 (intramuscular injection)
16048859|NCT02533310|Other|OST treatment with in-vivo spiders|Subjects are exposed to phobic stimuli with the aid of a trained psychotherapist during a session of maximum 3 hrs duration. The intensity of exposure is increased in four sequential steps, 1. learning to catch a spider with a glass and paper, 2. touching a spider, 3. letting a spider walk on your hand, 4. letting a spider walk on your body. These stages repeat with increasingly larger spiders. The goal of therapy is not absolute symptom reduction but sufficient reduction to allow the individual to expose themselves in everyday situations.
16048860|NCT02533310|Other|VR-OST treatment with virtual spiders|The VR-OST treatment introduces a virtual gamified version of OST treatment using a modern virtual reality headset. Individuals advance themselves through increasing levels of exposure intensity with the assistance of an automated virtual therapist.
16048861|NCT02533297|Other|Providing clinical skills conditions|
16048862|NCT02533284|Drug|Magnesium Sulfate|preemptive US guided TAP block will be done using Bupivacaine 0.25% plus 0.5 gm MgSo4 in M group).
16048863|NCT02533284|Drug|bupevecaine|US guided TAP using Bupevecaine 0.25 %
16048864|NCT02533284|Drug|saline|US guided TAP using placebo (saline)
16048865|NCT02533271|Radiation|Short-course radiotherapy with neoadjuvant chemotherapy|Short-course radiotherapy with 4 cycles of neoadjuvant chemotherapy
16048866|NCT02533271|Radiation|Long-term chemoradiotherapy|Standard chemoradiotherapy
16048867|NCT02533245|Other|Home-based indiviualized exercise training program|Based on these results of the cardiopulmonary exercise test (CPET) on a cycle ergometer, an individualized training program (cycling/hiking) is prescribed by a physical therapist for 6 months (3x/week, ≥30min/session).
16048868|NCT02533245|Other|Supervised group training sessions|7 supervised group training sessions (cycling/hiking) are organized by a physiotherapist
16048869|NCT02533245|Other|Climb of the Mont Ventoux|Cycle or hike up the Mont Ventoux (25.7 km, average slope 4.5%)
16048870|NCT02533232|Drug|Minocycline|Minocycline 200mg per day
16048871|NCT02533219|Drug|18 F-DOPA|Subjects will undergo PET imaging with [18F]-DOPA. All PET imaging will be performed after administration of a single dose (0.08 - 0.16 mCurie/kg) of [18F]-DOPA. PET imaging can be performed on either Philips Ingenuity TF PET/MRI or PET/CT.
16048872|NCT02533206|Procedure|Endoscopic Polypectomy Performed in Clinic|Endoscopic polypectomy performed in clinic under local and topical anesthesia
16048873|NCT02533206|Procedure|Functional Endoscopic Sinus Surgery (FESS)|Functional Endoscopic Sinus Surgery
16048874|NCT02533193|Procedure|ERAS perioperative cares|"Patient's preoperative counseling & education before surgery
~No Bowel preparation
~Drug: Oral Carbohydrate Solution (OCS). Take 250ml OCS orally 2 hours before surgery
~Fluid restriction & Management by pulse contour analysis or transesophageal doppler
~Early mobilization
~Early oral feeding (postoperative 1 day - liquid diet, 2 days - semifluid diet (SFD), 3 days - normal diet)
~Intravenous patient controlled analgesics (no opioids analgesics)
~Postoperative Nausea Active Control
~No nasogastric tube
~No drain insertion
~Patients will be discharged at POD#4 if there's no problem"
16048875|NCT02533193|Procedure|Conventional perioperative cares|"No Patient's preoperative counseling & education before surgery
~Bowel preparation
~No Oral Carbohydrate Solution (OCS) loading until 2hours before surgery
~Conventional Fluid Management by clinical signs (Urine output, heart rate etc.)
~Conventional Mobilization
~Conventional oral feeding (POD#2 SOW, #3 SFD, #4 SBD)
~IV PCA
~Postoperative Nausea Control if needed
~No Thromboembolism prophylaxis
~No or Low Content Oxygen therapy
~Drainage tube insertion if needed"
16048876|NCT02533180|Biological|Immunosuppression withdrawal|"Participants will initiate calcineurin inhibitor (CNI) withdrawal after at least 3 weeks of stable liver function, as documented by liver function tests (direct bilirubin, alanine aminotransferase and gamma-glutamyl transferase) separated by at least 1 week in the 3 week period prior to withdrawal.
~CNI withdrawal will occur in eight 3 week intervals with each subsequent reduction based on liver function tests over the prior 3 week interval.
~Participants on CNI and prednisone will undergo withdrawal from the two therapies concurrently.
~If participants are weaned off the CNI successfully, they will initiate non-CNI withdrawal. The non-CNI withdrawal includes two dose reductions of approximately 50% over a 6 week period each, after which the drug will be discontinued."
16048877|NCT02533167|Other|skin to skin|initiating skin to skin is not currently the standard of care at our facility so there is 1 interventional arm for this study. control group of no skin to skin until recovery room already established as is the standard of care.
16048878|NCT02533154|Drug|Prosicca|Prosicca eyedrops Dosage: on demand Route of administration: topical
16048879|NCT02533154|Drug|Prosicca sine|Prosicca sine eyedrops Dosage: on demand Route of administration: topical
16048880|NCT02533154|Other|Bacterial culture|bacterial cultures obtained with conjunctival swabs
16048881|NCT02533141|Device|Dynamic Vessel Analyzer (DVA)|Measurement of flicker induced vasodilatation, retinal vessel diameters and oxygen saturation
16048882|NCT02533141|Device|Laser Doppler Velocimetry (LDV)|Measurement of red blood cell velocity in retinal vessels
16048887|NCT02533115|Drug|CPX-351|"CPX-351 (cytarabine:daunorubicin) Liposome for Injection is a liposomal formulation of a fixed combination of the antineoplastic drugs cytarabine and daunorubicin. The two drugs are present inside the liposome in a 5:1 molar ratio shown to act synergistically in pre-clinical studies. The liposome membrane is composed of distearoylphosphatidylcholine, distearoylphosphatidylglycerol and cholesterol in a 7:2:1 molar ratio.
~CPX-351 is provided as a sterile, pyrogen-free, purple, lyophilized product in 50 mL glass, single-use vials. Each 50 mL vial after reconstitution contains 20 mL of CPX-351 (5 units/mL). Each unit (u) contains 1 mg cytarabine and 0.44 mg daunorubicin base in liposomes suspended in sucrose. Product is stored at 5˚ ± 3PoPC."
16048888|NCT02533102|Drug|E7050|100 mg tablet administered orally
16048889|NCT02533089|Other|KT intervention|Multifaceted KT intervention employing peer-trainer led educational outreach, a point of care reminder tool, and a peer mentoring network.
16048890|NCT02533076|Other|Challenge agent: capsaicin|"During the study period (Day 1), in each subject 3 equally spaced (minimum distance of 4 cm) 10-mm rubber O-rings (8 mm inner diameter) will be placed on the volar surface of the forearm. The most proximal ring (i.e. at least 15 cm proximal of the wrist crease) is referred to as ring number 1; the most distal ring is referred to as ring number 3; in between is ring number 2.
~In ring number 1 and 2, subjects will receive a topical dose of 1000 µg/20 µL capsaicin (single-blind). Change in dermal blood flow induced by capsaicin will be measured with Laser Doppler Imaging."
16048891|NCT02533076|Other|Challenge agent: placebo|"During the study period (Day 1), in each subject 3 equally spaced (minimum distance of 4 cm) 10-mm rubber O-rings (8 mm inner diameter) will be placed on the volar surface of the forearm. The most proximal ring (i.e. at least 15 cm proximal of the wrist crease) is referred to as ring number 1; the most distal ring is referred to as ring number 3; in between is ring number 2.
~In ring number 3, subjects will receive a topical dose of placebo (single-blind).Change in dermal blood flow induced by placebo will be measured with Laser Doppler Imaging."
16048892|NCT02533076|Device|Mechanical stimulation with Von Frey filaments|Von Frey filaments will be used to measured the mechanical detection and pain threshold of the volunteers. The Von Frey filaments will be applied on the upper capsaicin spot in sequential order. The subject will be asked to indicate when he feels the application of the Von Frey filaments and when it hurts.
16048893|NCT02533076|Device|Temperature sensitivity measurement with Advanced Thermal Stimulation|Temperature sensitivity (detection and pain threshold) will be determined using Advanced Thermal stimulation. A thermode will be attached to the hand of the volunteer with a baseline temperature of 32°C. The thermode will heat up and cool down with a rate of 1°C/second and the volunteer will be asked to click on a computer mouse when he feels the change in temperature and when it hurts.
16048894|NCT02533063|Device|VibeTech One|"Vibration Training The VibeTech One Rehab Chair allows vibration exercise while seated. A force is applied on a footplate that simulates the weight of standing or partial bodyweight. The participants will train for 10 minutes 3 days per week. In the loading + vibration group (intervention group) vibratory acceleration will be 30Hz and the applied load will be 50% of body weight up to a device maximum applied load of 100 lbs. Vibration intensity will initially be set to 0.2 g and will increase by 0.2 g every other week, as tolerated by the subject, and max out at 1.0 g."
16048895|NCT02533050|Device|CPAP treatment|Patients treated wear a face mask during sleep which is connected to a pump (CPAP machine) that forces air into the nasal passages at pressures high enough to overcome obstructions in the airway and stimulate normal breathing.
16048896|NCT02533037|Other|Traditional Instability Tools|Participants will complete 12 sessions over 4-weeks of impairment-based rehabilitation that incorporates ankle range of motion, ankle strength, balance, and functional activity exercises. For the balance and functional activity exercises, participants will use traditional instability tools.
16048897|NCT02533037|Other|Ankle Destabilization Shoes|Participants will complete 12 sessions over 4-weeks of impairment-based rehabilitation that incorporates ankle range of motion, ankle strength, balance, and functional activity exercises. For the balance and functional activity exercises, participants will use ankle destabilization shoes.
16048898|NCT02533024|Other|Electromyography|All subjects will have an EMG before, during and immediately after surgery.
16048899|NCT02533011|Other|HBP lab test|Plasma level of Heparin Binding Protein will be evaluated on extra blood specimens already collected as part of standard of care.
16048900|NCT02532998|Drug|AZD9977 oral suspension|AZD9977 oral suspension, single dose
16048901|NCT02532998|Drug|AZD9977 placebo oral suspension|oral suspension, single dose
16048902|NCT02532998|Drug|Fludrocortisone, tablets|Loading dose of 0.5 mg and maintenance doses of 0.1 mg every second hour up to a total dose of 1.0 mg per treatment period (may be modified to up to 1.3 mg based on emerging data)
16048903|NCT02532998|Drug|Eplerenone, tablets|100 mg (2 x 50 mg tablets) single dose, may be modified based on emerging data (will not exceed 500 mg per treatment period)
16048904|NCT02532985|Other|Negative Control|No added fiber beverage
16048905|NCT02532985|Other|Positive Fiber Control|positive control fiber supplemented beverage provided over 4 servings
16048906|NCT02532985|Other|Novel Fiber|novel fiber supplemented beverage provided over 4 servings
16048907|NCT02532985|Other|Novel Fiber|novel fiber supplemented beverage provided over 4 servings
16048908|NCT02532985|Other|Novel Fiber|novel fiber supplemented beverage provided over 4 servings
16048909|NCT02532972|Device|Med-el MAESTRO Cochlear Implant with Flex 28 electrode array|Cochlear Implant (CI) surgery followed by device activation, testing, and clinical assessment for 12 months following surgery.
16048910|NCT02532959|Device|Diagnostic Breath Analysis|Conduct exhaled breath samples
16048911|NCT02532946|Behavioral|Bedsider.org counseling|Contraceptive counseling was done while women kept the computer/tablet throughout their visit to facilitate discussion of website information with their providers.
16048912|NCT02532933|Device|DePuy Synthes Attune PS RP|
16048913|NCT02532907|Procedure|Liver Biopsy|patients will get a research liver biopsy pre-DAA treatment and either 4 or the standard 12 week time point. The liver biopsy is performed using standard protocol with ultrasound guidance.
16048914|NCT02532894|Device|Electronic cigarette|Inhaling e-cigarette vapor
16048915|NCT02532881|Other|Videos|Various videos showing four characteristic patient stories and five expert statements on special topics concerning inpatient psychosomatic rehabilitation.
16048916|NCT02532881|Other|Treatment as usual|Treatment as usual
16048917|NCT02532868|Drug|MK-0457|
16048919|NCT02532855|Drug|Dapagliflozin|Dapagliflozin 5 mg or 10 mg oral capsule. Up-titration to dapagliflozin 10 mg daily may be delayed if participant is unable to tolerate up-titration in the opinion of the investigator. Dapagliflozin 10 mg daily may be down-titrated to dapagliflozin 5 mg daily if participant is unable to tolerate the higher dose in the opinion of the investigator.
16048920|NCT02532855|Drug|Metformin|This medication is a standard-of-care medication and is administered in an open-label fashion. Supply of background metformin oral tablet(s) (at least 1500 mg daily) will be the responsibility of the participant throughout the duration of the study.
16048921|NCT02532855|Drug|Matching placebo to sitagliptin|Matching placebo to sitagliptin 100 mg oral tablet
16048922|NCT02532855|Drug|Matching placebo to dapagliflozin|Matching placebo to dapagliflozin 5 mg or 10 mg oral capsule. Up-titration to matching placebo to dapagliflozin 10 mg daily may be delayed if participant is unable to tolerate up-titration in the opinion of the investigator. Matching placebo to dapagliflozin 10 mg daily may be down-titrated to matching placebo to dapagliflozin 5 mg daily if participant is unable to tolerate the higher dose in the opinion of the investigator.
16048923|NCT02532855|Drug|Sulfonylurea|This medication is a standard-of-care medication and is administered in an open-label fashion. The dose of the sulfonylurea agent will be required to be at least 50% of maximum labeled dose, consistent with near maximum efficacy of the sulfonylurea agent.
16048924|NCT02532829|Other|blood sample analysis|Measurement of GLP-1, Peptide YY, Glucose and Insulin before and 30-60-120 minutes after Oral Mixed Meal Tolerance Test.
16048925|NCT02532816|Dietary Supplement|Nutrient dense complementary foods|"Mothers/caregivers will receive optimized CFRs to improve children diets and fortified biscuits (3 types of biscuit) for 6 days per week (in 12 months).
~Nutrition eduction for mothers/caregivers. Monthly body weight and length/height measurements"
16048926|NCT02532803|Other|Novel Pelvic MRI scan assessment|A novel MRI assessment of early rectal cancers will be provided for all patients in MINSTREL
16048927|NCT02532790|Drug|Prednisone|1.5mg/kg/d
16048928|NCT02532790|Drug|ACEI|0.2-0.3mg/kg/d
16048929|NCT02532777|Drug|Prednisone|
16048930|NCT02532777|Drug|Cyclophosphamide(CTX)|
16048931|NCT02532777|Drug|Mycophenolate mofetil(MMF)|
16048932|NCT02532777|Drug|Leflunomide(LEF)|
16048933|NCT02532777|Drug|Angiotensin-converting enzyme inhibitor(ACEI)|
16048934|NCT02532777|Drug|Methylprednisolone|
16048935|NCT02532764|Drug|QR-010|Single-stranded RNA antisense oligonucleotide in aqueous solution for oral inhalaton
16048936|NCT02532764|Drug|Placebo|Normal Saline
16048937|NCT02532738|Drug|Routine Treatment of CD|The Drug including 6MP, AZA, infliximab and thalidomide
16048938|NCT02532738|Biological|MSC treatment 01|Injection of 3×10E6/kg of MSC
16048939|NCT02532738|Biological|MSC treatment 02|Injection of 6×10E6/kg of MSC
16048940|NCT02532738|Other|NS|Injection of NS
16048941|NCT02532725|Procedure|Cardiopulmonary Exercise Stress Test|Test preceded by warm-up treadmill walking 5 min at 4.8 km/h, 5% grade with a 1 min sitting rest period. Test, then, begins at 4.8 km/h, 2.5% grade with incremental grade increases every 2 min until exhaustion. Ambient environment is maintained at neutral, with effective temperature of 19-21° C. Heart, lungs, temperature, and sweating is monitored during testing.
16048942|NCT02532725|Procedure|Climatic-Controlled Cardiopulmonary Exercise Stress Test|Test includes 30 min walking bouts on the treadmill, with two 5 min sitting rest periods between bouts (Rest I and Rest II) and 15 min sitting recovery period (Rest III), in effective temperatures of 21.1 (baseline), 26.7, 29.4, 32.2, and 35.0° C. Heart, lungs, temperature, and sweating is monitored during testing.
16048943|NCT02532725|Procedure|Body Composition Evaluation|Multiple methods are used to accurately estimate percentage of body mass (weight) composed of fat, muscle, bone, and other connective tissues. Four different methods, including caliper and hydrostatic (underwater weighing) are used in this study to ensure an accurate estimation.
16048944|NCT02532725|Procedure|Pre-Exercise Risk Assessment|Includes non-invasive measurements of body functioning, a physical examination by a physician, and blood and urine testing to select subjects who can exercise with relative safety.
16048945|NCT02532712|Drug|EC-18|EC-18 Soft-capsule (500mg/1 capsule)
16048946|NCT02532712|Drug|Placebo|Placebo with same shape and size
16048947|NCT02532699|Dietary Supplement|AC mycelia|An 8 week double-blinded randomized placebo-controlled parallel study with 2 week follow-up period was performed in mild hypertension subjects. Consenting eligible subjects were receive three capsules per day containing either 420 mg of AC mycelia of similar appearance for 8 weeks. The subjects were required to visit at baseline, every two weeks during the intervention period (8 weeks), and at follow-up 2 weeks after treatment had ended. During each study visit, systolic and diastolic BPs were recorded, fasting blood samples were collected and anthropometric measurements were performed. Compliance was evaluated using a food diary and monitored with biweekly telephone calls.
16048948|NCT02532699|Dietary Supplement|Placebo|An 8 week double-blinded randomized placebo-controlled parallel study with 2 week follow-up period was performed in mild hypertension subjects. Consenting eligible subjects were receive three capsules per day containing 420 mg starch placebo of similar appearance for 8 weeks. The subjects were required to visit at baseline, every two weeks during the intervention period (8 weeks), and at follow-up 2 weeks after treatment had ended. During each study visit, systolic and diastolic BPs were recorded, fasting blood samples were collected and anthropometric measurements were performed. Compliance was evaluated using a food diary and monitored with biweekly telephone calls.
16048949|NCT02532686|Drug|DAAOI-2|500-2000mg/d, oral, for 6 weeks
16048950|NCT02532686|Drug|placebo|oral, for 6 weeks
16048951|NCT02532660|Drug|Escitalopram 10mg|Escitalopram 10mg (1 pill once a day)
16048952|NCT02532660|Drug|LABCAT TCJUSS|LABCAT TCJUSS 1000mg daily (two 250mg capsules in the morning + 2 capsules of 250 mg at night)
16048953|NCT02532660|Drug|LABCAT TCJUSS Placebo|LABCAT TCJUSS placebo daily (2 capsules in the morning + 2 capsules at night);
16048954|NCT02532660|Drug|Escitalopram Placebo|Escitalopram Placebo (1 pill once a day)
16048955|NCT02532647|Drug|Remimazolam|
16048956|NCT02532647|Drug|Midazolam|
16048957|NCT02532647|Drug|Placebo|
16048958|NCT02532634|Drug|ramosetron, aprepitant, dexamethasone|ramosetron 0.3 mg IV D1 aprepitant 125 mg PO D1, 80 mg PO D2, 80 mg PO D3 dexamethasone 12 mg PO D1, 8 mg PO D2-4
16049043|NCT02532036|Biological|Aerosol inhaled MVA85A|
16048959|NCT02532634|Drug|palonosetron, aprepitant, dexamethasone|palonosetron 0.25 mg IV D1 aprepitant 125 mg PO D1, 80 mg PO D2, 80 mg PO D3 dexamethasone 12 mg PO D1, 8 mg PO D2-4
16048960|NCT02532621|Device|Venous InterGraft Connector|This is a pivotal multicenter, prospective, non-randomized adaptive design study. The planned study enrollment is 104 evaluable subjects who require AV graft placement for hemodialysis and who meet the entry criteria. The subjects will receive the VIG device and will have either a standard sutured arterial anastomosis or have received an AIG device for the arterial anastomosis (VIG-AIG subgroup). This number may be expanded following a planned interim analysis to up to 185 evaluable subjects for the primary study evaluation.
16048961|NCT02532608|Other|Acute sleep deprivation|Participants will stay awake for 36 hours
16048962|NCT02532595|Procedure|manual therapy and exercise|soft tissue mobilization, stretches, concentric and eccentric strengthening
16048963|NCT02532595|Procedure|trigger point dry needling|trigger point dry needling to trigger points located in the gastrocnemius, soleus and tibialis posterior
16048964|NCT02532569|Biological|Japanese encephalitis vaccine|Dosage and administration: After reconstitution with 0.7 mL of the provided diluent, 0.5-mL dose is administered subcutaneously in the lateral aspect of the upper arm.
16048965|NCT02532556|Device|Electrical stimulation (Digitimer)|Stimulation with Digitimer (DS7A HV, Digitimer Ltd, UK) over motor point of muscle in protocol. 1Hz, pulse duration 1ms, maximum compliance voltage 200V. Current set to twice motor threshold
16048966|NCT02532543|Biological|Allograft, Membrane|Allograft, Membrane- Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane
16048967|NCT02532543|Biological|Alloplast, Membrane|Alloplast, Membrane- Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane
16048968|NCT02532543|Biological|Xenograft, Membrane|Xenograft, Membrane- OsteoGraf/N-300,Symbios OsteoShield Collagen Resorbable Membrane
16048969|NCT02532543|Biological|Membrane|Membrane - Symbios OsteoShield Collagen Resorbable Membrane
16048970|NCT02532530|Device|Near-Infrared Spectroscopy (NIRS)|Near infrared spectroscopy (NIRS) is a non-invasive technique that uses near infrared light between 700 and 1100nm which penetrates several centimeters through skin and bone structures. Light is absorbed by chromophores. There are multiple chromophores which can be detected in the NIR spectrum such as water, lipids, melanin, myoglobin, oxygenated hemoglobin and deoxygenated hemoglobin. Each chromophore has a specific absorption spectrum. By using different wavelengths, it is possible to differentiate chromophores. The difference between oxygenated hemoglobin and deoxygenated hemoglobin can be calculated using the modified Beer-Lambert law, resulting in a numeric value which is a representation of the regional cerebral oxygen saturation.
16048971|NCT02532517|Device|CODMAN ENTERPRISE® Vascular Reconstruction Device and Delivery System|
16048972|NCT02532504|Other|CBT|"8 sessions of CBT based intervention called change your life with seven sheets of paper by Prof. Chris Williams. These sheets cover key skills of CBT that are;
~Five Areas vicious circle
~Bad thought spotter
~Amazing Bad thought Busting Programme (ABTPB)
~Easy 4 Step plan
~Things you do that mess you up/Confidence sheet
~Happy List/ Things you do that boost how you feel sheet
~Planner and Review sheets"
16048973|NCT02532491|Drug|Aripiprazole|Initial dose: 10 mg.
16048974|NCT02532491|Drug|Risperidone|Initial dose: 2 mg.
16048975|NCT02532465|Device|Air-Q|
16048976|NCT02532465|Device|i-gel|
16048977|NCT02532452|Biological|Viral Specific VST Infusion|"3rd party VSTs will be infused into immunocompromised patients who have evidence of viral infection or reactivation defined as any of the following:
~Blood adenovirus PCR ≥ 1,000
~Blood CMV PCR ≥ 500
~Blood EBV PCR ≥ 9,000
~Plasma BKV PCR >1,000
~Plasma JC Virus PCR > 1,000
~Evidence of invasive adenovirus infection or disease, defined as the presence of adenoviral positivity by PCR or culture in one or more sites.
~Evidence of invasive CMV infection, eg pneumonitis, retinitis, colitis
~Evidence of EBV-associated lymphoproliferation (EBV-LPD) defined as proven EBV-LPD by biopsy or probable EBV-LPD defined as an elevated EBV DNA level in the blood associated with clinical symptoms (adenopathy or fever or masses on imaging) but without biopsy confirmation, or EBV-associated malignancies.
~Evidence of symptomatic BK virus infection, which may include symptomatic hemorrhagic cystitis, or BK nephropathy.
~Evidence of PML or other CNS infection due to JC virus."
16048978|NCT02532439|Device|HR-pQCT|"Xtreme CT® device is a high resolution peripheral quantitative computed tomography (HR-pQCT) used to measure bone density and quantify the bone architecture to 3D at the extremities of the human body.
~For the study, the device will be used to assess bone density and microarchitecture at the forearm and shin for a systemic effect. In rheumatoid arthritis, bone density and microarchitecture will also be measured at the metacarpophalangeal."
16048979|NCT02532439|Device|DEXA|The Lunar Dual Energy X-ray Absorptiometry (DEXA) is a third generation multi-captor DEXA device that allow short duration measurements. It measures Bone Mineral Density (BMD) at the spine and the femoral neck
16048980|NCT02532439|Device|pQCT|Peripheral Quantitative Computed Tomography (pQCT) will be performed and measure bone and muscle parameters.
16048981|NCT02532426|Procedure|Muscle biopsy|The biopsy is performed on the vastus lateralis muscle at rest and 2 hours after an acute exercise, with a local anesthesia.
16048982|NCT02532413|Drug|Poly IC|Poly IC can induce innate immune responses.It may enhance the antiviral efficacy of Entecavir.
16048983|NCT02532413|Drug|Entecavir|Entecavir can inhibit the replication of HBV.
16048984|NCT02532400|Drug|Neoadjuvant endocrine therapy|Goserelin: 3.6mg, d1, hypodermic injection , q28d*7 plus exemestane: 25mg, po, qd*24w, or anastrozole: 1mg, po, qd*24w
16048985|NCT02532400|Drug|Neoadjuvant chemotherapy|Docetaxel: 75mg/m2, d1, q3w*6, Epirubicin 75mg/m2, d1, q3w*6 and Cyclophosphamide: 500mg/m2, d1, q3w*6
16048986|NCT02532387|Other|Telephone follow-up|Prospectively enrolled subjects will have a 7- and 30-day phone call.
16048987|NCT02532374|Other|Nicorette® inhalator|Subjects will inhale the Nicorette® inhalator (15 mg) at the rate of one deep inhalation every 15 seconds on average, over approximately 20 minutes (80 inhalations in total).
16048988|NCT02532374|Other|P3L|Subjects will inhale P3L (50 µg/puff, 80 µg/puff and 150 µg/puff) at the rate of one inhalation every 30 seconds on average, over approximately 6 minutes (i.e., 12 inhalations in total).
16049037|NCT02532075|Other|Control Trial|Control Trial. No respiratory muscle warm up to act as a comparison to the other three intervention trials.
16049038|NCT02532062|Dietary Supplement|Cholecalciferol|4,000 IU, oral, once a day for one year
16049039|NCT02532062|Dietary Supplement|multivitamin|oral, once a day for one year
16048989|NCT02532361|Device|Hysteroscopic device placement including Essure (ESS305, BAY1454032)|Essure is a permanent, minimally invasive, non-hormonal implantable device used for contraception and Adiana sterilization method is a combination of controlled thermal damage to the lining of the fallopian tube followed by insertion of a non-absorbable biocompatible silicone elastomer matrix within the tubal lumen
16048990|NCT02532361|Procedure|Tubal ligation|Tubal ligation or tubectomy is a surgical procedure for sterilization in which a woman's fallopian tubes are clamped and blocked, or severed and sealed, either method of which prevents eggs from reaching the uterus for implantation
16048991|NCT02532348|Other|Blood samples|Blood samples
16048992|NCT02532335|Drug|Obeticholic acid|active drug
16048993|NCT02532335|Drug|Obeticholic acid placebo|matching placebo
16048994|NCT02532322|Drug|IV acetaminophen|IV acetaminophen 15 mg/kg (1.5 mL/kg) IV loading dose prior to incision, followed by a 15 mg/kg (1.5 mL/kg) dose given every 6 hours for the first 24 hours after surgery (total of 4 doses postoperatively)
16048995|NCT02532322|Drug|normal saline|normal saline 1.5 mL/kg IV loading dose prior to incision, followed by a 1.5 mL/kg dose given every 6 hours for the first 24 hours after surgery (total of 4 doses postoperatively)
16048996|NCT02532309|Drug|Rosuvastatin (5mg，10mg，20mg)|Rosuvastatin dose adjusted by LDL-c level( If LDL-C>1.1mmol/L and <1.8mmol/L, administrated as 5mg/day.If LDL-C ≥1.8mmol/L, adjusted every 4 weeks as 5mg，10mg，20mg.
16048997|NCT02532309|Drug|Rosuvastatin 5mg|Rosuvastatin 5mg/day
16048998|NCT02532296|Behavioral|Transition Coach (TC)|"TC reviews patient's medical record to understand current admission and the medical/psycho-social history. TC makes introductory hospital visit(s) with patient to establish rapport and to define post-discharge needs.
~Starting in-house and continuing after discharge, TC helps patient set transition goals to maximize healthcare outcomes. Post-discharge, TC offers a voluntary face-to-face visit with patient along with weekly outreach calls, which are designed to assist patient with goal setting and attainment, medical system navigation; medication management; medical follow-up; transportation; use of community resources; and self-care.
~Intervention lasts 30 days post-discharge; afterwards TC seeks to handoff to an outpatient care team member, to ensure continuity of care."
16048999|NCT02532296|Behavioral|Control|Receives usual hospital-based care, discharge preparation, transitional care and outpatient care.
16049000|NCT02532283|Drug|JNJ-63623872|Participants will be administered JNJ-63623872 600 milligram (mg) tablets orally twice daily for 7 days.
16049001|NCT02532283|Drug|Placebo|Participants will be administered placebo tablets orally twice daily for 7 days.
16049002|NCT02532283|Drug|Oseltamivir|Participants will be administered oseltamivir 75 mg capsules orally twice daily for 7 days.
16049003|NCT02532270|Drug|phenylephrine|When systolic blood pressure decreased by over 20% of the basic value or systolic blood pressure lower than 100mmHg after spinal anaesthesia,phenylephrine was administered 50ug in Group C and Group N.If systolic blood pressure did not improve after 1 minute,phenylephrine was administered repeatedly until systolic blood pressure return to normal.
16049004|NCT02532257|Drug|Ibrutinib|Given PO
16049005|NCT02532257|Other|Laboratory Biomarker Analysis|Correlative studies
16049006|NCT02532257|Drug|Lenalidomide|Given PO
16049007|NCT02532257|Biological|Rituximab|Given IV
16049008|NCT02532244|Other|sample collection|collection of blood
16049009|NCT02532231|Other|Laboratory Biomarker Analysis|Correlative studies
16049010|NCT02532231|Biological|Nivolumab|Given IV
16049011|NCT02532218|Drug|ARI-3037MO|Lipid lowering treatment Statins
16049012|NCT02532192|Drug|Belinostat|"Dose Escalation Phase Starting Dose: 200 mg/m2/d by vein on Days 1 and 2 of a 21 day cycle.
~Dose Expansion Starting Dose: Maximum tolerated dose from Dose Escalation Phase."
16049013|NCT02532192|Drug|Rituximab|Dose Escalation and Dose Expansion Phases: 375 mg/m2 by vein on Day 2 of a 21 day cycle.
16049014|NCT02532192|Drug|Cisplatin|Dose Escalation and Dose Expansion Phases: 100 mg/m2 by vein on Day 2 of a 21 day cycle
16049015|NCT02532192|Drug|Cytarabine|"Dose Escalation Phase: 2 g/m2 by vein on Day 3 of a 21 day cycle. Two doses given every 12 hours.
~Dose Expansion Phase: 2g/m2 by vein on Day 2 of a 21 day cycle. Two doses given every 12 hours."
16049016|NCT02532192|Drug|Dexamethasone|Dose Escalation and Dose Expansion Phases: 40 mg by mouth on Days 2 - 5 of a 21 day cycle.
16049017|NCT02532192|Drug|Ciprofloxacin|500 mg by mouth twice daily for 10 days.
16049018|NCT02532192|Drug|Fluconazole|100 mg by mouth daily for 10 days.
16049019|NCT02532179|Biological|Mouse Allergenic Extract|Subjects will receive escalating doses of glycerinated mouse allergenic extract administered subcutaneously up to a maximum study dose (MSD) of 0.4 mL of extract at a concentration of 1:10 wt/vol., per protocol.
16049020|NCT02532166|Other|Esophageal lichen planus|White light endoscopy compared to narrow band imaging and Lugol for detection of esophageal lichen.
16049021|NCT02532153|Drug|Ketamine Hydrochloride|Single open-label infusions
16049022|NCT02532140|Drug|WCK 5107 250 mg to 2000 mg|
16049023|NCT02532140|Drug|Cefepime 2000 mg|
16049024|NCT02532140|Drug|WCK 5107 1000/2000 mg with Cefepime 2000 mg combination|
16049025|NCT02532140|Drug|Placebo|
16049026|NCT02532127|Other|Saliva sampling|Cells will be collected from consenting participants just before and after (30 min and 24 hr) exposure to CBCT, by brushing a swab against the inner cheek, which can be done by the patients themselves. Swab kits are provided together with an envelope for sending the swabs back.
16049027|NCT02532114|Drug|Enzalutamide|Given PO
16049028|NCT02532114|Other|Laboratory Biomarker Analysis|Correlative studies
16049029|NCT02532114|Drug|Niclosamide|Given PO
16049030|NCT02532114|Other|Pharmacological Study|Correlative studies
16049031|NCT02532101|Dietary Supplement|Oil Palm Phenolics|Palm fruit derived phenolics compound
16049032|NCT02532088|Dietary Supplement|Oil Palm Phenolics|Palm fruit derived phenolics compound
16049033|NCT02532088|Dietary Supplement|Placebo|Placebo
16049034|NCT02532075|Other|Inspiratory Warm Up|Inspiratory muscle warm up. Inhaling against a resistance for two sets of 15 breaths using a PowerLung.
16049035|NCT02532075|Other|Expiratory Warm Up|Expiratory muscle warm up. Exhaling against a resistance for two sets of 15 breaths using a PowerLung.
16049036|NCT02532075|Other|Combination Warm Up|Combination of inspiratory and expiratory muscle warm up. One set of 15 breaths inhaling followed by one set 15 breaths exhaling.
16049046|NCT02532036|Biological|Aerosol inhaled Saline placebo|
16049047|NCT02532023|Dietary Supplement|omega 3 fatty acid|omega 3 fatty acid supplement, 2× 1000 mg softgel daily (1800 mg EPA+DHA per day), 2 times a day, for 2 months
16049048|NCT02532023|Dietary Supplement|curcumin|curcumin supplement, 2× 500 mg softgel daily (1000 mg curcumin per day), 2 times a day, for 2 months
16049049|NCT02532023|Dietary Supplement|omega 3 fatty acid placebo|omega 3 fatty acid placebo softgel (Containing 2 g edible paraffin oil), 2× 1000 mg softgel daily (2 g per day), 2 times a day, for 2 months
16049050|NCT02532023|Dietary Supplement|curcumin placebo|curcumin placebo softgel (Containing 1 g starch powder), 2× 500 mg softgel daily (1 g per day), 2 times a day, for 2 months
16049051|NCT02532010|Drug|Pacritinib|Pacritinib is a novel Janus kinase 2-fms-like receptor tyrosine kinase 3 (JAK2-FLT3) inhibitor that has shown promising antitumor activity. Pacritinib is a potent inhibitor of JAK2 and FLT3 kinase activities (50% inhibitory concentration (IC50) = 23 nanomolar (nM)and 22 nM, respectively). The drug also inhibits cellular proliferation in human leukemia and lymphoma cell lines selected for their dependence on either of the target kinases. Consistent with these activities, exposure to pacritinib resulted in the reduction of phos-JAK2, phos-STAT3 or phos-STAT5 in the relevant cell lines. Unlike some JAK2 inhibitors, pacritinib does not inhibit Janus kinase 1 (JAK1).
16049052|NCT02532010|Drug|Decitabine|Commercial drug: For each cycle Decitabine 20mg/m2 intravenous daily for 10 days combined with ongoing pacritinib 200 mg twice daily.
16049053|NCT02532010|Drug|Cytarabine|Commercial drug: For each cycle Cytarabine 20mg subcutaneous twice daily for 10 days combined with ongoing pacritinib 200mg twice daily.
16049054|NCT02531997|Behavioral|Hypnotic Relaxation Therapy|There are 3 induction scripts that build upon each other, each about 20 minutes in length. The first focuses on relaxation, feelings of wellness, wholeness, strength, and confidence. The second focuses more on body image related to sexuality, sexual desire, passion, and romanticism. The third includes suggestions from the previous inductions, but adds a behavior that the woman chooses to incorporate for the last 2 weeks of the intervention. A digital recording will be provided of the intervention content for home practice.
16049055|NCT02531997|Behavioral|Progressive Muscle Relaxation|Women will be instructed how to do progressive relaxation and will be given the opportunity to ask questions and express concerns. The research therapist will utilize a script to focus the conversation on relaxation and planning the implementation of the behavior. Participants will be given a digital recording of 4 pleasant background sounds to facilitate their relaxation practice. Home practice will be encouraged.
16049056|NCT02531984|Drug|Azithromycin|
16049057|NCT02531971|Drug|Intravenous fentanyl citrate|100 micrograms (2 millilitres) via intravenous injection
16049058|NCT02531971|Drug|Duragesic®|TDDS dosage is 25 micrograms/hour (worn for 72 h)
16049059|NCT02531971|Drug|Mylan generic fentanyl|TDDS dosage is 25 micrograms/hour (worn for 72 h)
16049060|NCT02531958|Other|Eggs|Participants will complete a 2-week washout period followed by intake of 1, 2, and 3 eggs per day for 4 weeks each.
16049061|NCT02531945|Device|Use of Biomod device|
16049064|NCT02531919|Drug|Sodium Bicarbonate|Given PO
16049065|NCT02531906|Drug|Gabapentin|Given PO
16049066|NCT02531906|Drug|Methadone Hydrochloride|Given PO
16049067|NCT02531906|Drug|Oxycodone Hydrochloride|Given PO
16049068|NCT02531906|Other|Quality-of-Life Assessment|Ancillary studies
16049069|NCT02531906|Other|Questionnaire Administration|Ancillary studies
16049071|NCT02531867|Biological|Asfotase Alfa|
16049072|NCT02531854|Drug|ADXS11-001|
16049073|NCT02531854|Drug|Pemetrexed|
16049074|NCT02531841|Drug|Arm A (Fortecortin®-ETOPOPHOS®-IFO-cell®-CARBO-cell®)|"Arm A 4 cycles MATRix (every 3 weeks), stem-cell harvest after 2nd cycle:
~Rituximab 375 mg/m²/d i.v. (d0,5)
~Methotrexate 3.5 g/m² i.v. (d1)
~Cytarabine 2 x 2 g/m²/d i.v. (d2-3)
~Thiotepa 30 mg/m² i.v. (d4) Consolidation 2 cycles of R-DeVIC (every 3 weeks):
~Rituximab 375 mg/m²/d i.v. (d0)
~Dexamethasone 40 mg/d i.v. (d1-3)
~Etoposide 100 mg/m²/d i.v. (d1-3)
~Ifosfamide 1500 mg/m²/d i.v. (d1-3)
~Carboplatin 300 mg/m² i.v. (d1)"
16049075|NCT02531841|Drug|Arm B (TEPADINA®-CARMUBRIS®-Busilvex®)|"4 cycles MATRix (every 3 weeks), stem-cell harvest after 2nd cycle:
~Rituximab 375 mg/m²/d i.v. (d0,5)
~Methotrexate 3.5 g/m² i.v. (d1)
~Cytarabine 2 x 2 g/m²/d i.v. (d2-3)
~Thiotepa 30 mg/m² i.v. (d4) Consolidation
~High-dose chemotherapy (HDT-ASCT):
~Carmustine* 400 mg/m² i.v. (d-6)
~Thiotepa 2 x 5 mg/kg/d i.v. (d-5-(-4))
~Autologous Stem Cell Transplantation (d0)
~* if carmustine is not available at the investigation site, busulfan can be administered instead:
~Busulfan 3,2 mg/kg/d (d-8-(-7))
~Thiotepa 2 x 5 mg/kg/d i.v. (d-5-(-4))
~Autologous Stem Cell Transplantation (d0)"
16049076|NCT02531828|Device|Application of dressings for surgical correction.|Dressing for surgical correction
16049077|NCT02531828|Device|POLYSHAFT®|
16049078|NCT02531815|Biological|PF-06741086|PF-06741086, single dose, beginning with Cohort 1 dose level at 30 mg. Subsequent dose levels will be determined after data review of prior cohort(s)
16049079|NCT02531815|Drug|Placebo|Placebo for PF-06741086, single dose
16049080|NCT02531802|Biological|ETVAX|"Varying dosages of liquid ETVAX vaccine (Batch BX1003574). A full dose consisted of:
~Hybrid protein between the B-subunit of the E. coli heat-labile enterotoxin and the B-subunit of the cholera toxin (LCTBA): 1 mg
~E. coli ETEX 21 formalin inactivated: 1.3 mg colonization factor 1 (CFA/I)
~E. coli ETEX 22 formalin inactivated: 6.4 mg coli surface antigen 3 (CS3)
~E. coli ETEX 23 formalin inactivated: 1.1 mg coli surface antigen 5 (CS5)
~E. coli ETEX 24 phenol inactivated: 0.5 mg coli surface antigen 6 (CS6)
~The vaccine was given together with sodium bicarbonate effervescent granules (Recip), which was dissolved in water and mixed with the vaccine suspension prior to oral administration. The buffer was used to prevent degradation of LCTBA hybrid protein by the gastric acid."
16049117|NCT02531529|Drug|dexmedetomedine|intraoperative infusion
16049118|NCT02531529|Drug|Fentanyl|
16049119|NCT02531516|Drug|Apalutamide|
16049120|NCT02531516|Drug|Bicalutamide|
16049081|NCT02531802|Biological|dmLT|Varying dosages of dmLT, a derivative of wild-type enterotoxigenic Escherichia coli LT that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine. These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules.
16049082|NCT02531802|Other|Bicarbonate Buffer|Sodium bicarbonate buffer dissolved in 150 ml of potable water
16049083|NCT02531789|Other|Observation|C3, C4, CRP, and the dilution marker total IgG, together with C3dg, TCC and Bb will be measured over a high-sampling frequency time course t=-1 (admission), 0 (induction), 2,4,8,16, 24, 36 and 48 hours.
16049084|NCT02531776|Device|Subcutaneous insertions of needles|"Various types of needles with different designs and mechanical properties.
~Five marketed needles are included: NovoFine 28G x 12 mm (Novo Nordisk A/S, Denmark), NovoFine 30G x 6 mm (Novo Nordisk A/S, Denmark), NovoFine 32G tip x 6 mm (Novo Nordisk A/S, Denmark), BD Ultra-Fine 32G x 4 mm Pentapoint (Beckton, Dickinson & Company, USA), and Terumo Nanopass 34G x 5 mm (Terumo, Japan).
~Ten needles have been exclusively manufactured for this clinical trial by Hart Needles, USA. These needles vary in diameter, number of needle tip grinding, and angles of grindings.
~Three needles have been modified from the original (NovoFine 32G x 6 mm) with lack of lubrication or damaged needle tip for simulations of repeated use.
~No drugs are injected. Only the needle insertion is evaluated."
16049085|NCT02531763|Behavioral|Social incentive intervention|Participant sign a pre-commitment pledge to try to achieve their goal. They are entered into a game with their teammate in which they have the chance to earn points and advance through levels (bronze, silver, gold, platinum). At the end, those in gold or platinum will receive a coffee mug as a reward
16049086|NCT02531750|Other|Immobilization due to an Achilles tendon rupture|
16049087|NCT02531737|Drug|vargatef®|Patients will be treated to oral nintedanib (vargatef®) 400 mg/d on days 2 to 21 of a 3-week cycle
16049088|NCT02531737|Drug|Docetaxel|Patients will be treated to IV docetaxel 75 mg/m² on day 1 of evry 3-week cycle
16049089|NCT02531724|Drug|Levosimendan|
16049090|NCT02531724|Drug|Placebo|Sodium chloride
16049091|NCT02531711|Other|Diet A|Experimental analgesic dietary intervention
16049092|NCT02531711|Other|Diet B|Healthy comparator diet
16049093|NCT02531698|Biological|Bivalent rLP2086 Vaccine|1 dose of 120 μg of bivalent rLP2086 by intramuscular injection at Months 0, 2, and 6 into the upper deltoid muscle of the arm.
16049094|NCT02531698|Biological|Licensed pediatric hepatits A vaccine|1 0.5 mL dose by intramuscular injection at Months 0 and 6 into the upper deltoid muscle of the arm.
16049095|NCT02531698|Other|Normal Saline|Sterile saline solution for injection (0.85% sodium chloride) in a 0.5 mL dose at Month 2.
16049096|NCT02531685|Other|Placebo|Placebo: 0.9% Sodium Chloride injection.
16049097|NCT02531685|Biological|Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine|LT(R192G/L211A), or dmLT is formulated as a freeze-dried (lyophilized), white to off-white cake, containing 700mcg of vaccine protein in a 3 ml, multi-dose.
16049098|NCT02531672|Drug|11C-choline|
16049099|NCT02531672|Device|PET/CT Scan|
16049100|NCT02531646|Radiation|Radiation|Radiation - Each human subject will receive one standard of care x-ray and one Duel Energy exposure or one standard of care x-ray and one Digital Tomosynthesis exposure. Phantoms were imaged using linear tomography and digital tomography.
16049101|NCT02531633|Drug|Sirukumab|Sirukumab will be provided as 1 millilitre (mL) Pre-filled Syringe (PFS), containing 100 mg/mL or 50 mg/mL of sirukuma, fitted with a spring-powered, disposable autoinjector device for single use SC administration of liquid biologic drug.
16049102|NCT02531633|Drug|Placebo to match sirukumab|Placebo to match sirukumab will be provided as 1.0 mL PFS fitted with a spring-powered, disposable autoinjector device for single use SC administration of liquid biologic drug.
16049103|NCT02531633|Drug|Prednisone|Prednisone will be provided as tablets with dosage level up to-60 mg/day. The prednisone dose for all subjects will be determined by the Investigator and starting doses will be within 20-60 mg prednisone at Baseline (Randomization).
16049104|NCT02531633|Drug|Placebo to match prednisone|Placebo to match prednisone will be provided as tablets.
16049105|NCT02531620|Other|Physiatry Assessment|Physiatrists are physicians who are medical experts in maximizing a patient's overall ability to function well and live independently. The Investigators are proposing your participation in an initial pilot study in order to test the question as to whether or not participation with a physiatrist and any interventions recommended by said physician would help improve a patient's postoperative recovery.
16049106|NCT02531620|Other|Routine Care|Usual care for your disease process
16049107|NCT02531607|Other|blood and bile|20ml of blood will be obtained from consented participants. 5ml of bile will be collected during the endoscopic procedure.
16049108|NCT02531594|Behavioral|SBIRT|"The Social Worker will provide caregivers with the brief (10-15 minute) Advise, Assess, Assist intervention based on the Clinical Practice Guidelines, and tailored on levels of motivation to quit and tobacco dependence. Patients in this group will receive Nicotine Replacement Therapy vouchers, immediate connection to cessation resources, and intervention materials."
16049109|NCT02531594|Behavioral|HHC|"The Social Worker will provide caregivers with the brief (10-15 minute) Lets Go! 5-2-1-0 intervention which is a child obesity prevention program. Patients in this group will receive motivational interviewing in regards to helping children and families eat healthy and be active. This group will receive water bottle vouchers, immediate connection to 5-2-1-0 resources, and intervention materials."
16049110|NCT02531581|Drug|Furosemide|furosemide 40 mg bolus with second bolus to 4 hours so inadequate diuretic response defined as urine output <500cc
16049111|NCT02531581|Drug|NaCl 9% isotonic|normal saline 500 cc / 4 hours and 1 L / 24 hours
16049112|NCT02531568|Drug|Warfarin|
16049113|NCT02531568|Drug|MT-3995|
16049114|NCT02531555|Device|810 Nanometer Wavelenght GaAlAs Diode Laser|FDA approved 810 nanometer GaAlAs Diode Laser
16049115|NCT02531555|Device|Gracey curettes|
16049116|NCT02531542|Device|Echocardiography according to the READ method.|"Echocardiography will be performed before any therapy is initiated by a fully trained operator, according to the READ method. The results of this ultrasound will not be communicated to the clinician managing the patient in the emergency room.
~A blood sample will be taken during the routine work-up for centralized evaluation of NT-proBNP levels."
16049121|NCT02531516|Drug|Bicalutamide Placebo|
16049122|NCT02531516|Drug|Apalutamide Placebo|
16049123|NCT02531516|Drug|GnRH (agonist)|
16049124|NCT02531516|Radiation|74-80 Grays (units of radiation)|
16049125|NCT02531503|Other|Clinical asthma remission|Clinical asthma remission was defined as having no asthma symptoms and no use of medication during the past 12 months.
16049126|NCT02531490|Drug|Labetalol|
16049127|NCT02531490|Drug|Nifedipine|
16049128|NCT02531490|Drug|Methyldopa|
16049129|NCT02531477|Drug|propofol|intracarotid propofol as an anesthetic agent
16049130|NCT02531464|Other|Supportive care|Systematic distress screening and needs assessment of family caregivers of patients with lung cancer
16049131|NCT02531451|Drug|Ibuprofen|
16049132|NCT02531451|Drug|Acetylsalicylic acid|
16049133|NCT02531438|Drug|Omadacycline|Injection for IV; Oral tablets
16049134|NCT02531438|Drug|Moxifloxacin|IV solution; Oral tablets
16049135|NCT02531425|Biological|IT-pIL12-EP|Intratumoral pIL-12 injections followed immediately by electroporation into accessible tumor lesions
16049136|NCT02531412|Drug|Spironolactone|After a major surgery event a time 0, 24h and 48h
16049137|NCT02531412|Drug|Placebo|After a major surgery event a time 0, 24h and 48h
16049138|NCT02531399|Device|FDOCT|Measurement of retinal blood velocities
16049139|NCT02531399|Device|LDV|Measurement of retinal blood velocities
16049140|NCT02531399|Device|DVA|Measurement of retinal vessel diameters
16049141|NCT02531399|Device|LSFG|Imaging of retinal blood flow
16049142|NCT02531386|Device|6 blood glucose monitoring systems for self-testing (blood glucose meters)|
16049143|NCT02531373|Biological|V114 Medium Dose|15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and Merck Aluminum Phosphate Adjuvant (125 mcg) in each 0.5 mL dose
16049144|NCT02531373|Biological|V114 High Dose|15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) in each 0.5 mL dose
16049145|NCT02531373|Biological|V114 Medium Dose with Alternative Carrier Protein|15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg), and Merck Aluminum Phosphate Adjuvant (125 mcg) with alternative carrier protein in each 0.5 mL dose
16049146|NCT02531373|Biological|V114 High Dose with Alternative Carrier Protein|15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19F, 19A, 22F, 23F, 33F (4 mcg each), serotype 6B (8 mcg), and Merck Aluminum Phosphate Adjuvant (250 mcg) with alternative carrier protein in each 0.5 mL dose
16049147|NCT02531373|Biological|Prevnar 13™|13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg) and 6B (4.4 mcg) in each 0.5 ml dose
16049148|NCT02531360|Drug|[18F]MNI-815 (MNI-815)|All enrolled subjects will undergo an [18F]MNI-815 PET imaging visit. As a part of the screening visit, subjects will undergo [18F]florbetaben (FBB) PET imaging to determine if they have significant amyloid deposition.
16049149|NCT02531347|Behavioral|Telemedical home blood pressure measurements|
16049150|NCT02531347|Behavioral|Conventional blood pressure monitoring|
16049151|NCT02531334|Dietary Supplement|TA-65|2 pills of TA-65 or placebo daily for 12 weeks. Subjects will be monitored weekly for side effects and every 4 weeks for compliance and safety monitoring. The whole intervention is a randomized double blind study for a duration of 27 weeks; 12 weeks for TA-65 or placebo allocated randomly and after a 3 week washout period, allocation to the alternate supplement TA-65 or placebo.
16049152|NCT02531321|Drug|Levonorgestrel and Ethinyl Estradiol|All participants will take a combined oral contraceptive containing 150mcg levonorgestrel and 30mcg ethinyl estradiol for 21 days. Pharmacokinetics and pharmacodynamics will be compared between participants using antiretroviral regimens including ritonavir-boosted protease inhibitors and those using regimens that do not interact with oral contraceptives.
16049153|NCT02531308|Drug|Metformin|Metformin upregulates AMPK activity which has been shown to have an anti-proliferative effect on lymphoma cells.
16049154|NCT02531308|Drug|Rituximab|monoclonal antibody against protein CD20 primarily found on the surface of B-cells
16049155|NCT02531308|Drug|Cyclophosphamide|Interferes with DNA replication
16049156|NCT02531308|Drug|Doxorubicin|anthracycline antitumor antibiotic
16049157|NCT02531308|Drug|Vincristine|Inhibits cell mitosis causing cell death.
16049158|NCT02531308|Drug|Prednisone|a synthetic corticosteroid drug that is particularly effective as an immunosuppressant drug. It is used to treat certain inflammatory diseases
16049159|NCT02531308|Drug|pegfilgrastim|stimulates the level of white blood cells (neutrophils).
16049160|NCT02531295|Drug|Euphorbia kansui extract powder prepared as tea|1 g of Euphorbia kansui extract powder, measured and reconstituted in 4 fluid ounces of boiled water allowed to cool and administered as tea, taken by mouth daily
16049161|NCT02531282|Behavioral|Patient education|Self-management patient education in groups once a week for 6 weeks. Each session include pain-related theory, group discussions and physical exercises focusing on posture and relaxation. Instructors with education in health promotion and behavioural change in addition to psychomotor physiotherapy.
16049162|NCT02531282|Behavioral|Physical activity|Physical activity once a week for a period of 6 weeks in form of walking and simple strength exercises outdoor in groups led by an instructor. Each session has a duration of one hour. The instructor has education in physical activity.
16049163|NCT02531256|Device|LMA Protector|Insertion of airway device for airway management during gynaecological procedure
16049164|NCT02531243|Behavioral|CALMS|Family Therapy; Multi-user Biofeedback Videogames
16049165|NCT02531230|Device|VascuFlex Multi-LOC®|Multi-LOC® peripheral stent system for bailout stenting after Plain Old Balloon Angioplasty (POBA) or Drug Coated Balloon (DCB) Angioplasty
16049166|NCT02531217|Biological|ATYR1940|Biological: ATYR1940
16049167|NCT02531204|Drug|ASP1585|oral
16049168|NCT02531191|Drug|peficitinib|oral
16049169|NCT02531178|Biological|ABBV-257|subcutaneous injection
16049170|NCT02531178|Biological|Placebo|Placebo for ABBV-257
16049300|NCT02530294|Drug|glycopyrronium Topical Wipes|Topical wipes containing glycopyrronium
16049171|NCT02531165|Drug|Fentanyl|Analgesia protocol using Fentanyl (initial dose: 50-100 mcg, additional doses of 25 mcg every 2-5 minutes to achieve adequate sedation, if required).
16049172|NCT02531165|Drug|Morphine|Analgesia protocol using Morphine (initial dose: 4-8 mg, additional doses of 2 mg every 5-15 minutes to achieve adequate sedation, if required).
16049173|NCT02531165|Drug|Ticagrelor|Pre-hospital Ticagrelor loading dose of 180 mg administered orally, followed by 90 mg bid
16049174|NCT02531165|Drug|Aspirin|500 mg loading dose orally (or intravenously), followed by 100 mg od
16049175|NCT02531165|Drug|Unfractioned Heparin|5'000 IU loading dose intravenously, additional doses to achieve an ACT >250 sec during PCI are allowed.
16049176|NCT02531165|Procedure|Primary PCI|Primary PCI with stent implantation according to the guidelines of the European Society of Cardiology.
16049177|NCT02531152|Drug|Latanoprost|
16049178|NCT02531152|Drug|SAR366234|
16049179|NCT02531139|Other|MAP maintained at 80 mmHg|Intervention group, MAP is maintained at 80 - 90 mmHg during anesthesia using continuous infusion of phenylephrine.
16049180|NCT02531139|Other|MAP maintained at 60 mmHg|Control group, MAP is maintained at minimum of 60 mmHg during anesthesia using continuous infusion of phenylephrine.
16049181|NCT02531126|Drug|RPC1063|
16049182|NCT02531113|Drug|RPC1063|
16049183|NCT02531100|Device|BonyPid 500TM implantation concomitantly to SOC treatment|BonyPid 500TM implantation concomitantly to SOC treatment
16049184|NCT02531100|Other|SOC treatment only|Standard of care treatment (Manual and ultrasonic debridement, and surface decontamination)
16049185|NCT02531074|Behavioral|Mobile Application|
16049186|NCT02531074|Behavioral|Food Journal|
16049187|NCT02531074|Behavioral|Usual Care|
16049188|NCT02531061|Device|HR-pQCT|"The Xtrem CT scanco device is a HR-pQCT. It was initially used to measure bone density and quantify the bone architecture to 3D at the extremities of the human body.
~For the study, the device will be used to measure changes in erosion at the 2nd or 3rd metacarpal head. Only the patient's hand will be in contact with the medical device, the acquisition time will be 3 minutes."
16049189|NCT02531048|Device|laser stimulations on lower limbs|20 laser stimulations for each site : back foot, outer face of the legs, and anterior thigh
16049190|NCT02531048|Device|laser stimulations cervical|15 laser stimulations cervical areas below the ears.
16049191|NCT02531048|Device|20 laser stimulations for each site on the upper limbs|20 laser stimulations for each site : back of the hands and arms front face
16049192|NCT02531048|Device|laser stimulations on face and neck|15 lasers stimulations for each site : mandibular areas and areas below the ears.
16049193|NCT02531035|Drug|Sotagliflozin|Sotagliflozin, once daily, before the first meal of the day
16049194|NCT02531035|Drug|Placebo|Placebo, once daily, before the first meal of the day
16049195|NCT02531022|Behavioral|Financial incentive|A daily financial incentive framed as a loss of $2 each day goal is not acheived
16049196|NCT02531022|Behavioral|Daily feedback|Daily feedback from an activity tracking device worn on the wrist to track step counts and sleep patterns
16049197|NCT02530996|Drug|BH4|BH4 10 mg/kg/day given once to a total of 12 SSc patients
16049198|NCT02530996|Diagnostic Test|Vasculopathy assessment|Non-invasive technique, flow mediated dilatation (FMD) to define vasculopathy in SSc.
16049199|NCT02530996|Drug|Placebo|On the experimental days, patients reported to the laboratory after having consumed a standardized breakfast and oral BH4 (10mg/kg) or placebo five hours prior to their arrival. All measurements were taken at the same time of day to eliminate any diurnal effects. All participants abstained from alcohol, caffeine, and exercise for ≥12 hours prior to the study. Additionally, vasodilatory medications were discontinued 12 hours prior to study visit. In premenopausal women, measurements were performed during the early follicular phase of the menstrual cycle. All measurements were made under quiet, comfortable, ambient (~22°C) laboratory conditions.
16049200|NCT02530983|Other|Mayo Clinic Conduit Report Card Questionnaires|Patients will be asked to complete the Mayo Clinic Conduit Report Card Questionnaires at their one month surgical follow up visit and then every three months for 1 year after surgery, then with each surveillance clinic visit or a minimum of once per year for their lifetime. The questionnaire can be completed at their clinic visit, over the telephone, or by mail. The patient's medical record will also be reviewed to gather any other contributing information.
16049201|NCT02530957|Device|Non invasive ventilation + High flow nasal cannula oxygen|In the interventional group, a preoxygenation by NIV (venturi mask of Intersurgical or Respironics mask) with PS of 10 cm H2O, PEEP of 5 cm H2O, FiO2 = 100% and combined to HNFC (nasal cannula oxygen of Fisher and Paykel) with Flow of 60L/min, FiO2 = 100% is applied.
16049202|NCT02530957|Device|Non invasive ventilation|In the reference group, a preoxygenation by NIV (venturi mask of Intersurgical or Respironics mask) only, with PS of 10 cm H2O, PEEP of 5 cm H2O, FiO2 = 100% is applied.
16049203|NCT02530931|Drug|Gadolinium|diffusion of gadolinium for a population with Meniere's disease in order to develop an imaging disease screening test
16049204|NCT02530918|Drug|DS-7080a|1.0, 2.0, or 4.0 mg administered by a 50 μL intravitreal (IVT) injection of solution
16049205|NCT02530918|Drug|Ranibizumab|0.3 mg or 0.5 mg administered by a 50 μL IVT injection of solution
16049206|NCT02530905|Drug|SRP-4045|SRP-4045 solution for IV infusion.
16049207|NCT02530905|Drug|Placebo|SRP-4045 placebo-matching solution for IV infusion.
16049208|NCT02530892|Procedure|EmbryoHug|"An oocyte or embryo will be gently held by a micropipette, and a small inward pressure will be applied to the edge of the oocyte or embryo. The response of the embryo to this pulling force will allow the investigators to measure its stiffness and viscosity. The term micropipette aspiration refers to the pressure applied to the edge of the embryo -- this procedure is not invasive and does not involve any sort of puncture or removal of material from the oocyte or embryo."
16049209|NCT02530879|Drug|Omeprazole, Lansoprazole, Esomeprazole, Rantidine|1.Omeprazole- Dose range oral, 20mg once a day, up to 40mg twice a day 2.Lansoprazole-Dose range 15mg per day- 30mg twice a day 3.Esomeprazole- Dose range oral, 20mg once a day, up to 40mg twice a day 4.Rantidine-Dose range: 150 mg twice a day or 300 mg
16049243|NCT02530658|Procedure|Blood Sample|For patients who have not previously provided a blood sample, a sample of blood will be obtained as a source of germline DNA.
16049301|NCT02530294|Other|Vehicle|Vehicle (placebo) topical wipes
16049820|NCT02526524|Drug|Met IR|metformin immediate-release tablets
16049210|NCT02530879|Behavioral|Voice therapy|Evaluation is completed over two, one-hour sessions. Once the evaluation is complete, the subject will begin weekly, individual voice therapy for 55 minute sessions per week with a second year graduate student under the direct supervision of the clinical faculty member.Treatment sessions will include a counseling component and an active exercise program.
16049211|NCT02530879|Other|Combination of anti-reflux medication and voice therapy|Subjects will receive both anti-reflux medication as detailed above and voice therapy as detailed above.
16049212|NCT02530866|Other|Lower glycemic targets|Women will be randomized to either standard or lower glycemic targets.
16049213|NCT02530853|Other|Laser acupuncture|Laser acupuncture
16049214|NCT02530840|Behavioral|medical team|Lowering HbA1c by behavioral changes in meetings with the medical team.
16049215|NCT02530840|Behavioral|peers group|Lowering HbA1c by behavioral changes in meetings with the peers group.
16049216|NCT02530840|Behavioral|SMS notification|Lowering HbA1c by behavioral changes in meetings with the SMS notification
16049217|NCT02530827|Drug|use of lipid-lowering drugs.|The patients shoud be in use of a lipid-lowering drugs previouly, at least one month before of the begining of the study.
16049218|NCT02530814|Other|Blood Collection|Onetime blood collection.
16049219|NCT02530801|Drug|Bevacizumab|Subconjunctival injection of Bevacizumab combined with 5 fluorouracil in the recurrent pterygium
16049220|NCT02530801|Drug|5 fluorouracil|Subconjunctival injection of Bevacizumab combined with 5 fluorouracil in the recurrent pterygium
16049221|NCT02530788|Drug|Selenium Supplement (sodium selenite)|"On the evening before operation the patient receives the first dosage of Selenium (300µg orally) orally as a pill.
~After induction of anaesthesia and before being put on the heart-lung-machine the patient receives 3000µg Selenium as sodium selenite (selenase® T) intravenous (as bolus infusion in the space of 30 minutes). In addition the patient gets 1000µg Selenium as sodium selenite (selenase® T) intravenous as bolus infusion in the space of 30 minutes after admission to ICU. On every POD the patient receives 1000µg Selenium as sodium selenite (selenase® T) intravenous as bolus infusion in the space of 30 minutes (until transfer to standard care unit or maximum substitution until 13th POD)."
16049222|NCT02530788|Drug|Placebo|"On the evening before operation the patient receives the first dosage of placebo orally as a pill.
~After induction of anaesthesia and before being put on the heart-lung-machine the patient receives placebo intravenous (as bolus infusion in the space of 30 minutes). In addition the patient gets placebo intravenous as bolus infusion in the space of 30 minutes after admission to ICU. On every POD the patient receives placebo intravenous as bolus infusion in the space of 30 minutes (until transfer to standard care unit or maximum substitution until 13th POD)."
16049223|NCT02530775|Procedure|instrumented spinal fusion with laminectomy|"Once determined that a patient has single level static degenerative spondylolisthesis and is planning to schedule surgery the patient will be approached by a research team member explaining the study and reviewing the informed consent document. If the patient chooses to participate, he or she will be randomized to be apart of the non-instrumented arthrodesis with laminectomy group or the instrumented arthrodesis with laminectomy group. Both are standard approved surgical approaches; however, using instrumentation is the more commonly used approach."
16049224|NCT02530775|Procedure|non-instrumented spinal fusion with laminectomy|"Once determined that a patient has single level static degenerative spondylolisthesis and is planning to schedule surgery the patient will be approached by a research team member explaining the study and reviewing the informed consent document. If the patient chooses to participate, he or she will be randomized to be apart of the non-instrumented arthrodesis with laminectomy group or the instrumented arthrodesis with laminectomy group. Both are standard approved surgical approaches; however, using instrumentation is the more commonly used approach."
16049225|NCT02530762|Other|Novel Fiber|novel fiber supplemented beverage provided in one serving
16049226|NCT02530762|Other|Positive Fiber control|positive control fiber supplemented beverage provided in one serving
16049227|NCT02530762|Other|Negative Control|No added fiber beverage
16049228|NCT02530736|Other|4 metre gait speed|Measurement of usual walking speed over 4 metres. Change in walking speed is measured at baseline (pre-pulmonary rehabilitation assessment) and 8 weeks later (post-pulmonary rehabilitation assessment)
16049229|NCT02530723|Other|power training|Resistance training machines with CAM devices will be used for training.
16049230|NCT02530710|Drug|Q203|
16049231|NCT02530710|Drug|Placebo|
16049232|NCT02530697|Drug|Meglumine antimoniate|20mgSb+5/kg/day meglumine antimoniate intravenous for 28 days.
16049233|NCT02530697|Drug|Miltefosine|Miltefosine 2,5mg/kg/day up to 50mg 2x/daily.
16049234|NCT02530697|Drug|Pentoxifylline|Pentoxifylline 20mg/kg/day up to 400mg 3x/daily for 28 days.
16049235|NCT02530684|Other|insole|Insoles available on the market without prescription
16049236|NCT02530671|Device|Toothbrushing with manual toothbrush|
16049237|NCT02530671|Device|Toothbrushing with power toothbrush|
16049238|NCT02530658|Other|Study Introduction Visit|Within 5±3 weeks following arrival at SJCRH, or at the participant/family's convenience, participants will meet with a genetic counselor and clinician, provide information for a family pedigree, undergo a physical and discuss germline testing options. Study introduction materials will be provided. Families interested in the G4K study will be referred to the study nurse or other G4K member and an Informed consent visit will be scheduled.
16049239|NCT02530658|Other|Informed Consent Visit|Within 1±3 weeks following the Study Introduction Visit, or at the participant/family's convenience, the research nurse or other study team member will consent the family and collect demographic and medical information. Participants will complete assessment questionnaires.
16049240|NCT02530658|Other|Informed Consent Follow-Up Visit|Within 2-4 weeks following the Informed Consent Visit, or at the participant/family's convenience, a subset of participants (30-40) will participate in semi-structured interviews.
16049241|NCT02530658|Other|Return of Results Conversation|Participants will complete the assessment questionnaires.
16049242|NCT02530658|Other|Return of Results Follow-Up Visits|Return of Results Follow-Up Visits will be conducted twice: the first within 8±4 weeks of the Return of Results Conversation, or at the participant/family's convenience, and the second within 32±8 weeks of the Return of Results Conversation or at the participant/family's convenience. At each visit, participants will complete assessment questionnaires. Semi-structured interviews with parents and adolescents will be conducted.
16049821|NCT02526524|Drug|Placebo|
16049244|NCT02530658|Procedure|Skin Biopsy|After consent, for participants with a diagnosis where peripheral blood is likely to be contaminated by tumor cells, skin biopsies may be done as a source of germline DNA.
16049245|NCT02530645|Behavioral|OnTrack|
16049246|NCT02530645|Behavioral|Treatment as Usual|
16049247|NCT02530645|Behavioral|Brief Motivational Interviewing|
16049248|NCT02530632|Drug|Propofol|General anesthesia maintained with intravenous propofol infusion
16049249|NCT02530632|Drug|Sevoflurane|General anesthesia maintained with inhalational sevoflurane
16049250|NCT02530632|Procedure|General anesthesia induction|Induce routine of general anesthesia, including propofol 1-3mg/kg, fentanyl 1-3mcg/kg, cisatracurium 0.2-0.3mg/kg.
16049251|NCT02530619|Drug|Alisertib|Given PO
16049252|NCT02530619|Other|Laboratory Biomarker Analysis|Correlative studies
16049253|NCT02530619|Other|Pharmacological Study|Correlative studies
16049254|NCT02530606|Procedure|Photoacoustic Imaging|Undergo PAI
16049255|NCT02530593|Behavioral|There is no intervention, only observation|
16049256|NCT02530580|Drug|20 mg AZD7325|A single 20 mg oral dose of AZD7325
16049257|NCT02530580|Drug|Placebo|A single oral dose
16049258|NCT02530567|Procedure|Intervention|All patients performing the biopsy will have an MRI to carry out the necessary measures.
16049259|NCT02530554|Drug|CHG|Single application
16049260|NCT02530541|Drug|CHG|Varied application times
16049261|NCT02530528|Drug|CHG|Varied application times
16049262|NCT02530515|Biological|Ex Vivo-activated Autologous Lymph Node Lymphocytes|Given IV
16049263|NCT02530515|Other|Laboratory Biomarker Analysis|Correlative studies
16049264|NCT02530502|Other|Laboratory Biomarker Analysis|Correlative studies
16049265|NCT02530502|Biological|Pembrolizumab|Given IV
16049266|NCT02530502|Radiation|Radiation Therapy|Undergo focal RT
16049267|NCT02530502|Drug|Temozolomide|Given PO
16049268|NCT02530489|Drug|Atezolizumab|Given IV
16049269|NCT02530489|Drug|Nab-paclitaxel|Given IV
16049270|NCT02530476|Drug|Selinexor|"Phase I Starting Dose of Selinexor: 80 mg by mouth twice weekly for a 28 day cycle.
~Phase II Starting Dose of Selinexor: Maximum tolerated dose from Phase I."
16049271|NCT02530476|Drug|Sorafenib|"Phase I Starting Dose of Sorafenib: 400 mg by mouth twice daily for a 28 day cycle.
~Phase II Starting Dose of Sorafenib: Maximum tolerated dose combination from Phase I."
16049272|NCT02530463|Drug|Azacitidine|Given IV
16049273|NCT02530463|Biological|Ipilimumab|Given IV
16049274|NCT02530463|Other|Laboratory Biomarker Analysis|Correlative studies
16049275|NCT02530463|Biological|Nivolumab|Given IV
16049276|NCT02530450|Device|continuous glucose monitoring (CGM)|All subjects in Groups 1 and 2 wore the CGM device at time points 0, 3 months, and 6 months. Group 1 did not review CGM data at time 0, but did review CGM data at time point 3 months and 6 months. Group 2 reviewed CGM data at all time points.
16049277|NCT02530437|Drug|Carboplatin|Given IV
16049278|NCT02530437|Radiation|External Beam Radiation Therapy|Undergo external beam radiation therapy
16049279|NCT02530437|Other|Laboratory Biomarker Analysis|Correlative studies
16049280|NCT02530437|Drug|Paclitaxel|Given IV
16049281|NCT02530437|Drug|Taladegib|Given PO
16049282|NCT02530424|Drug|Trastuzumab|Trastuzumab (8 mg/kg loading dose IV, then 6 mg/kg IV) will be given on day 1 q. 3 weeks for a total of 6 administrations
16049283|NCT02530424|Drug|Pertuzumab|Pertuzumab (840 mg as an i.v. infusion) will be given on day 1 q. 3 weeks for a total of 6 administration
16049284|NCT02530424|Drug|Palbociclib|Palbociclib will be given at the dose of 125 mg po q.d. x 21 every 4 weeks (i.e. 1 week rest period for a total of 5 cycles
16049285|NCT02530424|Drug|Fulvestrant|Fulvestrant will be administered according to local prescription guidelines and will be given intra-muscle at the dose of 500 mg every 4 weeks (repeat for 5 times) with an additional 500 mg dose given two weeks after the initial dose
16049286|NCT02530411|Drug|Fulvestrant|The pharmacology and mode of action studies established that fulvestrant is the first agent in a new class of anti-estrogens that down-regulate the estrogen receptor (ER), and can therefore be described as an ER down-regulator.
16049287|NCT02530411|Drug|Vandetanib|Vandetanib is a potent inhibitor of the tyrosine kinase activity of vascular endothelial growth factor receptor (VEGFR; also known as kinase insert domain containing receptor)-2, an endothelial cell receptor for vascular endothelial growth factor (VEGF), and also possesses activity against epidermal growth factor receptor (EGFR) and Rearranged during Transfection (RET) tyrosine kinases.
16049288|NCT02530398|Drug|Cinobufacini Injection|Cinobufacini injection is extracted from a traditional Chinese medicine Bufo toad skins, it's something cold and poisonous with damp evil. On one hand it can kill the cancer cells direct; on the other hand it has the ability to contract blood vessels and inhibit the formation of tumor new vessels. It has been widely used in the treatment of various malignancies.
16049289|NCT02530385|Other|Placebo Capsules|Placebo capsules contain powdered cocoa and gelatin
16049290|NCT02530385|Biological|FMT Capsules|Capsules will be generated as per FDA-approved procedures
16049291|NCT02530372|Device|UriCap-F|non-invasive urine collection device for women
16049292|NCT02530359|Drug|Pirfenidone extended release|Pirfenidone extended release 600mg per mouth
16049293|NCT02530359|Drug|Placebo equivalent|Placebo equivalent per mouth
16049294|NCT02530346|Drug|No Mechanical Bowel Preparation|no enemas or oral laxatives will be given in this group
16049295|NCT02530346|Drug|Mechanical Bowel Preparation|oral laxatives (polyethylenglycol at 100 ml/kg/dose for up to 3 times) and stoma enemas (20mlkgdo of normal saline 3 times a day) will be prescribed
16049296|NCT02530333|Other|Neuromuscular Prevention Program|Participants in the intervention group will complete at 6 week ACL injury prevention program previously described in the literature as being effective at reducing ACL injury risk. The prevention program lasts 20-25 minutes in duration and will take place as a warm-up prior to any practice. The frequency will depend solely on the number of practices each team holds throughout the given 6-week time period.
16049297|NCT02530320|Drug|Palbociclib|Palbociclib will be administered orally at a dose of 125 mg/day, until disease progression, unacceptable adverse side effects or study end.
16049298|NCT02530307|Drug|HT-3951|
16049299|NCT02530307|Drug|Placebo|
16049302|NCT02530281|Drug|glycopyrronium Topical Wipes|Topical wipes containing glycopyrronium
16049303|NCT02530281|Other|Vehicle|Vehicle (placebo) topical wipes
16049304|NCT02530255|Dietary Supplement|cycloastragenol|Oral telomerase activator - cycloastragenol.
16049305|NCT02530255|Dietary Supplement|placebo (for cycloastragenol)|placebo comparator, placebo for cycloastragenol.
16049306|NCT02530242|Device|End-tidal Carbon Monoxide Subjects|ETCO monitor will be used to measure CO levels in subjects and controls.
16049307|NCT02530242|Device|End-tidal Carbon Monoxide Controls|ETCO monitor will be used to measure CO levels in subjects and controls.
16049308|NCT02530216|Other|AEGIS (Automated Evaluation of Gastrointestinal Symptoms)|"AEGIS (Automated Evaluation of Gastrointestinal Symptoms) guides patients through questionnaires to measure symptom attributes including the timing, severity, frequency, location, quality, and character of their gastrointestinal (GI) symptoms, along with relevant comorbidities, family history, and alarm features. This information is transformed into a history of present illness (HPI) written in language familiar to clinicians. AEGIS also supports both the clinician and patient with an individualized education prescription which guides the patient through a library of multi-media educational materials on GI symptoms, conditions, and treatments. The prescription is created by the portal based on each patient's unique AEGIS fingerprint."
16049309|NCT02530203|Device|Spinal Cord Stimulation System|High frequency stimulation using a catheter placed in the lumen of the spine to inhibit sympathetic outflow to the heart
16049310|NCT02530203|Device|Holter Recording_ NEMon DR220 Holter Recorders|To measure primary endpoint and most of the secondary endpoints in all the patients enrolled in the study. The recording will start to before CABG procedure and will be stop at day 5.
16049311|NCT02530190|Device|intermittent pneumatic compression|20 minutes of intermittent pneumatic compression to lower extremities
16049312|NCT02530190|Procedure|massage|20 minutes of massage to lower extremities
16049313|NCT02530177|Other|Clinical Assessments|
16049314|NCT02530177|Behavioral|Questionnaires|
16049315|NCT02530177|Other|Saliva sample|(only once, preferably at baseline)
16049316|NCT02530164|Device|Transcranial direct current stimulation (tDCS)|active/sham tDCS as adjunctive treatment with a SSRI
16049317|NCT02530151|Drug|Morphine with clonidine|see arm description
16049318|NCT02530151|Other|Normal saline|see arm description
16049319|NCT02530138|Dietary Supplement|synbiotic|2 symbiotics capsules per day for 28 weeks
16049320|NCT02530138|Dietary Supplement|Placebo|2 placebo capsules per day for 28 weeks
16049321|NCT02530125|Other|Laboratory Biomarker Analysis|Correlative studies
16049322|NCT02530125|Biological|Pidilizumab|Given IV
16049323|NCT02530112|Other|Survey|
16049324|NCT02530099|Procedure|CN-group|Time limited simulation based training on camera navigation tasks on a virtual reality-simulator.
16049325|NCT02530099|Procedure|Procedure-group|Time limited simulation based training on laparoscopic procedure on a virtual reality-simulator.
16049326|NCT02530086|Procedure|Nasogastric tube placement|Placement of a Nasogastric tube
16049327|NCT02530086|Procedure|No Nasogastric tube use|No placement of a Nasogastric tube
16049328|NCT02530073|Device|Fetoscopic Endoluminal Tracheal Occlusion (FETO)|This study will position and remove an endoluminal tracheal balloon in utero (FETO) to study the feasibility of implementing FETO therapy in the most severe group of fetuses with left CDH and observed/expected length head ratio <25% (O/E LHR).
16049329|NCT02530060|Drug|Rilpivirine/Tenofovir Disoproxil Fumarate/Emtricitabine FDC|Fixed dose combination tablet contains 25 milligram (mg) of Rilpivirine, 300 mg of Tenofovir Disoproxil Fumarate (TDF) and 200 mg of Emtricitabine (FTC).
16049330|NCT02530047|Genetic|MSC-INFβ|"MSC-INFβ administered on an outpatient basis via intraperitoneal (IP) infusion.
~Starting dose: 10^5 MSC/kg once a week for 4 treatments."
16049331|NCT02530047|Behavioral|Questionnaires|Symptom questionnaire completed once a week for 4 weeks.
16049332|NCT02530034|Drug|Anti-PR1/HLA-A2 Monoclonal Antibody Hu8F4|Given IV
16049333|NCT02530034|Other|Laboratory Biomarker Analysis|Correlative studies
16049334|NCT02530034|Other|Pharmacological Study|Correlative studies
16049335|NCT02530021|Other|Heart rate monitor|One hour non-invasive ECG heart rate variability monitoring. The results will be blinded and interpreted independantly. Study results will not effect patient management.
16049336|NCT02529995|Drug|AZD9291 40 mg|This is a two parts (Part A and Part B) study to determine the pharmacokinetics of AZD9291 administered orally at two dose levels (40 mg Cohort 1 and 80 mg Cohort 2) in patients with locally advanced or metastatic NSCLC who have progressed following prior therapy with an EGFR TKI agent (+/- additional chemotherapy regimens).
16049337|NCT02529995|Drug|AZD9291 80 mg|This is a two parts (Part A and Part B) study to determine the pharmacokinetics of AZD9291 administered orally at two dose levels (40 mg Cohort 1 and 80 mg Cohort 2) in patients with locally advanced or metastatic NSCLC who have progressed following prior therapy with an EGFR TKI agent (+/- additional chemotherapy regimens).
16049338|NCT02529982|Dietary Supplement|Curcumin|
16049339|NCT02529982|Dietary Supplement|Placebo|
16049340|NCT02529969|Dietary Supplement|curcumin|
16049341|NCT02529969|Dietary Supplement|Placebo|
16049342|NCT02529956|Drug|UCB4940|"Active Substance: UCB4940
~Pharmaceutical Form: Solution for infusion
~Concentration: 80 mg/ml
~Route of Administration: Intravenous use"
16049343|NCT02529956|Other|Placebo|"Active Substance: Placebo
~Pharmaceutical Form: Solution for infusion
~Concentration: 0.9 % sodium chloride aqueous solution
~Route of Administration: Intravenous use"
16049344|NCT02529930|Biological|VB10.16 Immunotherapy (DNA vaccine)|Patients will receive 3 vaccinations of 3 mg VB10.16 at the pre-specified time points. VB10.16 will be administered intramuscularly in the area over the lateral deltoid muscle.
16049345|NCT02529917|Dietary Supplement|Hemp powder|Hemp powder supplement
16049346|NCT02529917|Dietary Supplement|Soy Powder|Soy powder supplement
16049347|NCT02529904|Biological|MF59 - ATIV|"All child participants will receive 2 doses of the MF59-ATIV, with the doses separated by 28 days.
~Adult participants will receive one dose of MF59-ATIV."
16049348|NCT02529891|Other|Measurement of VOC in exhaled air|Measurement of VOC in exhaled air during 10 min (tidal breathing) with a portable mass spectrometer
16049416|NCT02529410|Procedure|Cardiac Resynchronisation Therapy|
16049349|NCT02529878|Drug|S1/Paclitaxel chemotherapy plus Apatinib|S1:60mg twice daily(after the breakfast and supper) for two weeks, and then suspend for one week Paclitaxel:150mg/m2,iv, 3h, at day1 Apatinib:500mg once daily
16049350|NCT02529865|Biological|Periurethral injection of autologous ADRCs and adipose tissue|1 mL of the isolated ADRC is injected into the region of the external urethral sphincter, and another 4 mL of the ADRC and 16mL autologous adipose cells is injected under the urethral mucosa.
16049351|NCT02529852|Drug|Lenalidomide|"Phase I Starting Dose Level: 15 mg by mouth on Days 1 - 14 of each 21 day cycle.
~Phase II Starting Dose Level: Maximum tolerated dose from Phase I."
16049352|NCT02529852|Drug|Obinutuzumab|Phase I and II: 1000 mg by vein on Days 1, 8, and 15 of Cycle 1 and Day 1 of Cycles 2 - 6.
16049353|NCT02529852|Drug|Cyclophosphamide|Phase I and II: 750 mg/m2 vein over about 1 hour on Day 1 of all cycles.
16049354|NCT02529852|Drug|Doxorubicin|Phase I and II: 50 mg/m2 by vein over about 15 minutes each on Day 1 of all cycles.
16049355|NCT02529852|Drug|Vincristine|Phase I and II: 1.4 mg/m2 by vein on Day 1 of all cycles.
16049356|NCT02529852|Drug|Prednisone|Phase I and II: 100 mg by mouth daily on Days 1 - 5 of each 21 day cycle.
16049357|NCT02529839|Procedure|Autologous bone marrow transplantation|IMMUNOABLATIVE NONMYELOABLATIVE AUTOLOGOUS BONE MARROW TRANSPLANTATION on Day 0
16049358|NCT02529839|Drug|Fludarabine|30mg/m2 on days -6 through -3
16049359|NCT02529839|Drug|Cyclophosphamide|50mg/kg on days -5 through -4
16049360|NCT02529839|Drug|Alemtuzumab|3mg on day -3, 9mg on day -2, 12 mg on day -1
16049361|NCT02529826|Procedure|Testicular Biopsy|An open testicular biopsy will be performed by an attending urologist under general anesthesia.
16049362|NCT02529813|Drug|Cyclophosphamide|Given IV
16049363|NCT02529813|Drug|Fludarabine Phosphate|Given IV
16049364|NCT02529813|Other|Laboratory Biomarker Analysis|Correlative studies
16049365|NCT02529813|Biological|Tisagenlecleucel|Given IV
16049366|NCT02529800|Drug|HIP1402|Tamsulosin HCl 0.4mg
16049367|NCT02529800|Drug|HGP0412|Tamsulosin HCl 0.2mg
16049368|NCT02529787|Drug|Doxirazole|1 capsule contains 60 mg Dexlansoprazole
16049369|NCT02529787|Drug|Dexilant|1 capsule contains 60 mg Dexlansoprazole
16049370|NCT02529774|Drug|Floxuridine (FUDR),Dexamethasone (DXM), Heparin in combination with Oxaliplatin and Capecitabine (CapeOX) or in combination with Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6)|"Hepatic Artery Infusion for four cycles:
~Floxuridine (FUDR) 500mg/d, Day 1-2; DXM 1mg/day added to FUDR 2-day infusion; Heparin 1000U/day added to FUDR 2-day infusion
~In combination with Systemic Chemotherapy CapeOX for 8 cycles:
~Oxaliplatin 130 mg/m^2 iv over 2 hours, Day 1. Capecitabine 850mg/m^2/d PO Bid, given in the morning and evening, Day 1-14
~Or in combination with Systemic Chemotherapy mFOLFOX6 for 12 cycles:
~Oxaliplatin 85mg/m^2 IV over 2 hours, Day 1. Leucovorin 400mg/m^2 IV over 2 hours, Day 1 5-fluorouracil (FU) 400mg/m^2 IV and then 2400mg/m^2 over 48 hours IV continuous infusion. Day 1"
16049371|NCT02529774|Drug|Oxaliplatin and Capecitabine (CapeOX) or Oxaliplatin and Leucovorin and 5-FU (mFOLFOX6)|"Systemic Chemotherapy CapeOX alone for 8 cycles:
~Oxaliplatin 130 mg/m^2 iv over 2 hours, Day 1. Capecitabine 850mg/m^2/d PO Bid, given in the morning and evening, Day 1-14
~Or Systemic Chemotherapy mFOLFOX6 alone for 12 cycles:
~Oxaliplatin 85mg/m^2 IV over 2 hours, Day 1. Leucovorin 400mg/m^2 IV over 2 hours, Day 1 5-fluorouracil (FU) 400mg/m^2 IV and then 2400mg/m^2 over 48 hours IV continuous infusion. Day 1"
16049372|NCT02529761|Drug|Sorafenib|Sorafenib will be supplied as 200 mg tablets. All subjects will take two tablets of sorafenib (200 mg tablets) twice daily (each morning and evening).
16049373|NCT02529761|Procedure|TACE|"The first treatment of TACE should be completed within 3-7 days after the administration of sorafenib started. In all cases, TACE consists of an injection containing a mixture of chemotherapeutic agents and lipiodol followed by embolization with polyvinyl alcohol (PVA) particles until complete stasis was achieved in the tumor-feeding vessels.Tumor-feeding vessels should be selected/superselected whenever possible. TACE will be repeated on demand depending on the radiological response."
16049374|NCT02529748|Other|Participants for Surface Skin Sampling|Skin wipe samples will be collected to quantify the amount of the test substances transferred to and from the surface of the participants' skin.
16049375|NCT02529748|Other|Elemental metallic lead|Consumer product fishing tackle made of elemental lead will be handled by the participants.
16049376|NCT02529748|Other|Tinopal|Tinopal, a fluorescent tracer, will be handled by the participants.
16049377|NCT02529735|Other|efficiency study|Blood pressure values measured for comparative lower limb and arm
16049378|NCT02529709|Other|High-Protein Condition|The participants will be fed a high-protein meal
16049379|NCT02529709|Other|High-Monounsaturated Fat Condition|The participants will be fed a high-monounsaturated fat meal
16049380|NCT02529696|Device|Accelerometer|Measures patient movement
16049381|NCT02529683|Drug|Nuvaring|contraceptive vaginal ring with ethinyl estradiol and etonogestrel
16049382|NCT02529670|Procedure|Laser|Low level laser therapy will be delivered through Laser Photon III ® (DMC) in the second lumbar dorsal root ganglion.
16049383|NCT02529670|Procedure|Drug: Lidocaine|1 mL of Lidocaine will be delivered in the second lumbar dorsal root ganglion through fluoroscopy.
16049384|NCT02529670|Procedure|Radiofrequency|Radiofrequency will be delivered during 300 seconds, 42oC in the second lumbar dorsal root ganglion.
16049385|NCT02529657|Radiation|Low Level Laser Therapy|In 23 randomized patients, LLLT (B-Cure, Good Energies ®, Israel), with CW diode laser - semiconductor Gallium Arsenide and aluminum (GaAlAs) will be applied during surgery (λ = 804 nm ± 2 , total exposure time of 240 s, energy density of 2.48 J/cm2 , average power of 40 mW , spot area of 3,876 cm2), in contact mode, for 60 seconds on the laminectomy site, 60 seconds and 120 seconds in the subcutaneous tissue of the skin over the wound bed, respectively. In the first and second day post surgery, will be collected the drainage output for analysis of interleukin 1, 4, 6, 8 and 10 (IL- 1, IL-4, IL -6, IL-8 and IL -10 ) and tumor necrosis factor alpha ( TNF -alpha ).
16049386|NCT02529657|Procedure|Placebo|In the operating room, lumbar laminectomy will be performed in 46 patients. During the surgery, 24 hours and 48 hours after surgery, the patients received the regular treatment after laminectomy and were induced to thing that were receiving low level laser therapy in their wound.
16049569|NCT02528227|Other|Language Games and Narrating Your Day Language Curriculum|Early language activity that parents can do with their infants
16049570|NCT02528227|Other|Feeding Safety|Part of Health and Safety Curriculum
16049387|NCT02529644|Behavioral|Taking It to the Pews (Comparison)|Pastors and Health Action Team members will be trained and receive manualized pastor/church liaison trainings on study procedures, HIV basics and local resources and coordination of HIV screening events. Comparison churches will receive: a) non-tailored project materials (videos, brochures) collected from health organizations and b) standard, non-tailored activities (e.g., community-based HIV testing events) coordinated by their church liaisons. The comparison churches will offer 3 HIV screening events and deliver 1-2 standard materials per month for the 12 month study period. All comparison churches will receive all Taking It to the Pews HIV Tool Kit materials after the completion of 12-month assessments.
16049388|NCT02529644|Behavioral|Taking It to the Pews (Experimental)|Pastors and Health Action Team members will be trained in treatment implementation procedures using the scripted, study implementation manual. Intervention churches will receive the TIPS HIV Tool Kit, including a study manual. These churches will hold a Kick-off event, where tools will be distributed, and motivational strategies implemented. After the Kick-off, liaisons will deliver 1-2 Tool Kit materials/activities per month through targeted multilevel church activities minimum of 24 tools over the 12 month study period. Two additional HIV screening events will be planned (one for community members) and will be open to all persons seeking screening, including study nonparticipants. Both groups will receive manualized pastor/church liaison trainings on study procedures, HIV basics and local resources and coordination of HIV screening events.
16049389|NCT02529631|Drug|orlistat 60 mg|"In order to have comparable calorie intakes, all participants followed the recommendations of the German clinical practice guidelines on the management and prevention of obesity.
~Due to the different appearance of tablets and capsules, a double dummy design was chosen, a blister strip for each day and each participant had to take the same amount of capsules and tablets per day. The content of the blister strips: three orlistat 60 g capsules plus six placebo tablets."
16049390|NCT02529631|Device|polyglucosamine|"In order to have comparable calorie intakes, all participants followed the recommendations of the German clinical practice guidelines on the management and prevention of obesity.
~Due to the different appearance of tablets and capsules, a double dummy design was chosen, a blister strip for each day and each participant had to take the same amount of capsules and tablets per day. The content of the blister strips: three blue placebo capsules plus two placebo tablets (morning) and four polyglucosamine tablets (noon and evening)."
16049391|NCT02529618|Device|integrated Display Enhanced Testing for Cognitive Impairment and mild traumatic brain injury (iDETECT)|iDETECT offers an open platform for an evaluation of cognitive, balance, and oculomotor performance after mild traumatic brain injury (mTBI). It is a rugged, portable, neurocognitive assessment tool designed specifically for use in field and triage settings for the rapid evaluation of functional neurologic impairment after potential concussive injury.
16049392|NCT02529618|Device|Riddell High Impact Technology (HIT) System|The Riddell HIT system incorporates six acceleration sensors into standard football helmets worn during practice and game play. A computerized sideline system captures information on linear and rotational acceleration, as well as magnitude, duration, and location of impact for each player
16049393|NCT02529618|Device|i1 Biometrics Vector Mouth Guard|The i1 Biometrics Vector Mouth Guard is an impact intelligence system that contains a collection of impact sensing mouth guards, housing accelerometer and gyroscope technology that allows real-time collection and storage of biomechanical impact data. Sensors in the mouth guard communicate directly with a sideline assessment base station and allows for immediate assessment and evaluation of hit exposure.
16049394|NCT02529605|Dietary Supplement|Product B® IsaGenesis®|This will be a crossover comparison of a one time dose of the liquid-gel formulation contained in 2 capsules; 1280 mg/capsule.
16049395|NCT02529605|Dietary Supplement|IsaGenesis®|This will be a crossover comparison of a one time dose of the dried powder extract contained in 2 capsules; 1070 mg /capsule.
16049396|NCT02529592|Biological|Endotoxin|
16049397|NCT02529592|Biological|Placebo|
16049398|NCT02529579|Other|iAPA-DC/CTL adoptive cellular immunotherapy|twice DC cell infusion and CTL cell infusion for 6 times
16049399|NCT02529579|Drug|Gemcitabine|standard Gemcitabine therapy
16049400|NCT02529553|Drug|LY3076226|Administered IV
16049401|NCT02529540|Other|Adjustable glasses|The glasses will be used for refraction and wearing within professional instructions.
16049402|NCT02529540|Other|Custom standard glasses|The custom standard glasses are made by the traditional standards after refraction.
16049403|NCT02529540|Other|Ready-made glasses|The glasses have been made already before the refraction in the hospital. And they will be chosen by prescription after refraction.
16049404|NCT02529527|Behavioral|MyFamilyPlan|Web-based preconception health education tool (interactive self-assessment) - to be completed by patient
16049405|NCT02529514|Drug|Baclofen|25 mg for 7 days at 10 pm every day
16049406|NCT02529514|Drug|Placebo|Placebo for 7 days at 10 pm every day
16049407|NCT02529488|Device|AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL|Multifocal IOL(near, intermediate, distance) implanted for long-term use over the lifetime of the cataract patient
16049408|NCT02529475|Drug|Gadoteric acid|Comparison with patients with Meniere's disease
16049409|NCT02529462|Genetic|NEUROPHARMAGEN-Guided Treatment|NEUROPHARMAGEN is a pharmacogenetic test developed by AB-BIOTICS S.A. that enables the specific analysis of Single-Nucleotide Polymorphisms related to the pharmacokinetics and pharmacodynamics of multiple psychoactive drugs. In this arm, psychiatrists have access to the results of the NEUROPHARMAGEN test to support their medication choices
16049410|NCT02529462|Drug|Treatment As Usual|Clinicians treat psychiatric patients in a naturalistic way, following their routine procedures, without access to the pharmacogenetic information provided by the NEUROPHARMAGEN test
16049411|NCT02529449|Drug|Placebo|Oral
16049412|NCT02529449|Drug|ASP1941|Oral
16049413|NCT02529423|Dietary Supplement|Multi-nutrient supplement|"Omega 3 fatty acids
~Folic acid
~Calcium
~Selenium
~Vitamin D3"
16049414|NCT02529423|Behavioral|Behavioral Activation|21 sessions (15 individual sessions and 6 group sessions) The intervention will include detailed analysis of each individual's behavior to determine idiosyncratic triggers and functions of unhelpful (e.g., mood-related snacking) and helpful food-related behavior, thereby, to reinforce helpful behaviors and to implement effective alternatives to unhelpful behaviors, building on behavioural approaches proven effective in depression.
16049415|NCT02529423|Other|Placebo|Placebo pills identical in look and taste but including no active ingredients
16049417|NCT02529397|Behavioral|Adaptive Working Memory Training|Participants will train for 30-40 minutes per day, five days per week at home for 5 weeks using an adaptive cognitive training program which becomes increasingly challenging as the participant masters each level. Behavioral classes will teach the principles of weight management and exercise.
16049418|NCT02529397|Behavioral|Non-adaptive cognitive training|Participants will train for 30-40 minutes per day, five days per week at home for 5 weeks using a non-adaptive cognitive training program. Behavioral classes will teach the principles of weight management and exercise.
16049419|NCT02529384|Other|Breast magnetic resonance scanning|Just a muti-b value series in breast MRI
16049420|NCT02529371|Device|UriCap-RM|UriCap-RM is comprised of a reusable part and a single use adhesive tape. The reusable part is applied over the urethral meatus and is held in position by a stabilizer and adhesive tape. It is connected to a standard urine collection bag. The UriCap-RM is used on male patients who would otherwise use diapers, a condom-type urine collection device or an indwelling catheter for urine collection.
16049421|NCT02529358|Behavioral|standardized text messages|Messages consist of relaxation techniques and mindfulness exercises as well as emotion regulation strategies
16049422|NCT02529358|Behavioral|Personalized text messages|Patients write their own messages
16049423|NCT02529358|Behavioral|Standardized text messages after 10 weeks|Messages consist of relaxation techniques and mindfulness exercises as well as emotion regulation strategies which are send to the patients 10 weeks after completing inpatient therapy
16049424|NCT02529345|Device|RoadSaver stent|lesion treated with RoadSaver stent of Terumo
16049425|NCT02529332|Dietary Supplement|Omega-3|Nature Made Ultra Omega3 Fish Oil 1400mg softgels contains 1000mg of omega 3 per serving. Participants will be instructed to take twice daily for 6 months.
16049426|NCT02529319|Procedure|MRI-Guided Ablation|Catheter ablation of AF will be guided by a DE-MRI of the patient's heart prior to the procedure.
16049427|NCT02529319|Procedure|Conventional Ablation|Catheter ablation of AF using pulmonary vein isolation (PVI) will be performed using the HRS guidelines.
16049428|NCT02529293|Drug|BioChaperone Lispro U-100|Injection of BioChaperone Lispro U-100
16049429|NCT02529293|Drug|BioChaperone Lispro U-200|Injection of BioChaperone Lispro U-200
16049430|NCT02529280|Behavioral|Intervention|Intervention includes 1) a 30-minute computer-based video (in English/Spanish), featuring instructional screens, graphics and animation to help participants understand the concepts presented. It will feature breast cancer patients who have participated in CTs, patients talking to their doctor or nurse and a bilingual narrator to guide participants. Video content will address common barriers and concerns regarding clinical trials, as well as the informed consent process, and how clinical trials are monitored and reviewed; 2) a bilingual easy to understand booklet with tailored information on clinical trials. The booklet will include many of the elements and messages featured in the video program; and 3) assistance from a trained, bilingual, bicultural, nurse navigator.
16049431|NCT02529267|Other|Standard of care|
16049432|NCT02529254|Behavioral|Video coaching session|A 30 minute video coaching session with a surgeon in witch the residaent and coach visualise the filmed anastomosis and where the surgeon gives constructive feedback.
16049433|NCT02529241|Drug|Group 1:LCB01-0371|"Period:LCB01-0371 Tablet 400 mg
~Period: LCB01-0371 Tablet 400 mg"
16049434|NCT02529241|Drug|Group 2:LCB01-0371|"Period:LCB01-0371 Tablet 800 mg
~Period: LCB01-0371 Tablet 1200 mg"
16049435|NCT02529228|Other|Meal (Eating) Frequency|Dividing meal intake into 2 or 6 meals with equal energy content
16049436|NCT02529228|Other|Protein Composition|Consuming meals with higher or lower protein.
16049437|NCT02529215|Behavioral|Just-in-time training (JITT)|The JITT training is a 20 minute simulation-based teaching session targeting: (1) CPR quality and (2) medication administration.
16049438|NCT02529202|Drug|Dexmedetomidine|Dexmedetomidine infusion
16049439|NCT02529189|Dietary Supplement|Beetroot Juice|70 ml of beetroot juice containing ~5 mmol of inorganic nitrate
16049440|NCT02529189|Dietary Supplement|Beetroot Juice|70 ml of beetroot juice which is nitrate-depleted
16049441|NCT02529176|Behavioral|Best-practice alert|The best-practice alert notifies physicians that their patient's telemetry monitoring duration has exceeded national guidelines and gives the physician the option to: discontinue monitoring if they feel it is clinically appropriate, dismiss the alert, or re-alert in four hours.
16049442|NCT02529163|Other|Late-life Schizophrenia ICP|"The ICP medication algorithms first trial begins with:
~Risperidone titrated to a max dose
~Failure to Risperidone will lead to a second trial with either:
~Quetiapine OR Aripiprazole
~If subject refuses or if this trial does not work, then offer:
~Ziprasidone or Loxapine
~Failure of 2 anti-psychotic trials results in:
~Clozapine trial
~If subject refuses a Clozapine trial then:
~Olanzapine offered
~titrations occur over 33-36 day period (inpatient) or 12 week period (out patient) with each 0.5 mg titration after the target dose requiring a CGI-E
~If compliance is an issue then a depot preparation:
~Paliperidone
~Risperidone
~Flupentixol
~Aripiprazole
~Physicians will be prompted for non-pharmacological interventions"
16049443|NCT02529163|Other|Treatment as Usual|"The TAU group will be offered non-pharmacological interventions such as (but not limited to):
~metabolic monitoring
~skin hygiene
~pain management
~nutritional counseling
~family counselling
~Financial/housing support
~Group CBT (Cognitive Behavioral Therapy)
~Physicians treating this group will use their own discretion as they will not be prompted like the ICP group.
~Pharmacological interventions contain anti-psychotic medication selected at the discretion of the treating physician provided it fall under the current standard of care such as:
~Risperidone
~Aripiprazole
~Quetiapine
~Olanzapine
~Paliperidone
~Clozapine
~Ziprasidone
~Max dosing and the time to reach the target dose is done at the discretion of the treating physician."
16049444|NCT02529150|Behavioral|Exercise|This is an exercise intervention study. All 10 participants will complete 26 weeks high dose exercise (60% of peak aerobic capacity 45 min/session, 5 sessions per week).
16049445|NCT02529124|Dietary Supplement|CONTROL|Maltodextrin (generic) in powder form, flavoured and instantised to be dissolved in water.
16049483|NCT02528851|Procedure|Extubation from endotracheal mechanical ventilation to CPAP|"Following randomization, the infants will be extubated to the higher CPAP group (CPAP level 2cm H2O higher than extubation EAP) or equivalent CPAP group (CPAP level equal to the extubation EAP) based on their allocation."
16049571|NCT02528227|Other|Car Seat Safety|Part of Health and Safety Curriculum
16049572|NCT02528227|Other|Bath Safety|Part of Health and Safety Curriculum
16049446|NCT02529124|Dietary Supplement|PROTEIN|The milk protein matrix (PROTEIN) comprised a 9:2:1 ratio of milk protein concentrate (MPC, 80% (w/w protein) Glanbia Nutritionals, Kilkenny, Ireland), whey protein concentrate hydrolysate, degree of hydrolysis 32% (WPC DH 32, 78% (w/w protein) Carbery Ingredients, Ballineen, Ireland), whey protein isolate hydrolysate, degree of hydrolysis 45% (WPI DH 45, 75% (w/w protein) Glanbia Nutritionals). The total protein content was 72.7g/100g powder. The protein matrix was supplemented with 2187mg/100g powder of milk-based calcium (Trucal™, Glanbia) and 57.3mg/100g powder vitamin D3 (cholecalciferol), flavoured and instantised to be dissolved in water.
16049447|NCT02529124|Behavioral|PHYSICAL ACTIVITY|A structured, progressive programme of exercises using resistance exercise bands supervised by clinical therapists undertaken three times per week for 24 weeks of the intervention.
16049448|NCT02529111|Device|"Echonavigator software"|
16049449|NCT02529098|Other|fMRI|functional magnetic resonance imaging
16049450|NCT02529085|Other|blood samples|blood samples for the bank
16049451|NCT02529072|Drug|nivolumab|Nivolumab is a fully human monoclonal antibody that targets the programmed death-1 (PD-1) cluster of differentiation 279 cell surface membrane receptor. PD-1 is a negative regulatory molecule expressed by activated T and B lymphocytes. Binding of PD-1 to its ligands, programmed death-ligands 1 and 2, results in the down-regulation of lymphocyte activation. Inhibition of the interaction between PD-1 and its ligands promotes immune responses and antigen-specific T cell responses to both foreign antigens as well as self-antigens. Nivolumab is expressed in Chinese hamster ovary cells and is produced using standard mammalian cell cultivation and chromatographic purification technologies. The clinical study product is a sterile solution for parenteral administration.
16049452|NCT02529072|Biological|DC|DCs are potent immunostimulatory cells that continuously sample the antigenic environment of the host and specifically activate cluster of differentiation 4 positive (CD4+) and cluster of differentiation 8 positive (CD8+) T-cells and B-cells. They are at the crossroads of many of the elegant networks of the immune system, and DCs represent the most promising contemporary biologic entity for realizing the promise of immunotherapy. Potent immune responses and encouraging clinical results have been seen in Phase I and II human clinical trials in systemic cancers. Numerous animal studies and the investigator's institution's humans studies have demonstrated potent antitumor responses using DC-based immunotherapy against MGs.
16049453|NCT02529059|Drug|Eviplera|A single-pill fixed dose combination of tenofovir 245mg, emtricitabine 200mg and rilpivirine 25mg once daily for 24 weeks.
16049454|NCT02529046|Dietary Supplement|CLA|CLA group received supplementation at a dose of 3.2 g/day (mixture of isomers of CLA isomers predominantly c9, t11 - 50% and c12, t10 - 80%). Aerobic exercise associated with CLA
16049455|NCT02529046|Behavioral|Placebo|Placebo group received 4 g/day of olive oil. Aerobic exercise
16049456|NCT02529033|Device|LIDCO Rapid, Pulmonary artery catheter|Hemodynamic monitoring systems
16049457|NCT02529020|Device|Mouthguard|Condition of wearing mouthguard
16049458|NCT02529020|Device|No mouthguard|Condition without mouthguard
16049459|NCT02529007|Device|Endo-cuff|Colonoscopy performed with endo-cuff attached to the colonoscope
16049460|NCT02529007|Other|Standard colonoscopy|Standard colonoscopy without end-cuff
16049461|NCT02528994|Dietary Supplement|L-serine|Participants will take dietary serine supplementation daily
16049462|NCT02528981|Drug|Probiotic|Lactobacillus GR-1 and RC-14
16049463|NCT02528981|Drug|Placebo|
16049464|NCT02528968|Behavioral|Educational Package|Patients will be invited to attend a PK educational session as part of the study protocol. This will form a discussion regarding clinical history and activity in the 6 months prior to study start, viewing of a short animated film giving additional detail on pharmacokinetics and prophylaxis in haemophilia A, followed by modelling of the patient's own PK and dose guidance based on 2 study blood samples.
16049465|NCT02528955|Radiation|A: De-Intensification RT primary tumor region|"A:
~Reduction of radiation dose in the primary tumor region to 56 Gy,
~Elective Radiotherapy of both neck sides"
16049466|NCT02528955|Radiation|B: De-Intensification RT contralateral lymph nodes|"B:
~No dose reduction in primary tumor region (prescribed dose in primary tumor region: 64 Gy)
~Reduction of target volume: only elective radiotherapy of the ipsilateral neck, no contralateral neck irradiation"
16049467|NCT02528955|Radiation|C. De-Intensification RT primary tumor region AND contralateral lymph nodes|"C:
~Reduction of radiation dose in the primary tumor region to 56 Gy, AND
~Reduction of target volume: only elective radiotherapy of the ipsilateral neck, no contralateral neck irradiation"
16049468|NCT02528942|Radiation|Radiation therapy|Radiation therapy will be given to study patients.
16049469|NCT02528929|Dietary Supplement|Gluten-free diet|Patients with IBS-D will commence a gluten-free diet for 6 weeks following dietetic input. They will be informed they do not have coeliac disease. They will however be blinded to whether or not they have any markers of at-risk serology. They will self-complete validated questionnaires over 6 weeks. Any subjects who opt to continue with a gluten-free diet thereafter of their own volition will be kept under observation as per routine clinical care.
16049470|NCT02528903|Drug|MHAB5553A|Single intravenous administration, at various doses, depending on the cohort
16049471|NCT02528903|Drug|Matching placebo|Single intravenous dose
16049472|NCT02528890|Other|vaginal/anal swab for GBS from all participants|All eligible pregnant women, who meet the inclusion criteria and gave their informed consent to participate in the study has to complete a questionnaire and have a vaginal / anal swab taken to identify positive GBS carriers by PCR (polymerase chain reaction) test.
16049473|NCT02528877|Procedure|Allogeneic Bone Marrow Transplantation|Undergo allogeneic bone marrow transplant
16049474|NCT02528877|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic hematopoeitic stem cell transplant
16049475|NCT02528877|Drug|Fludarabine Phosphate|Given IV
16049476|NCT02528877|Other|Laboratory Biomarker Analysis|Correlative studies
16049477|NCT02528877|Drug|Melphalan|Given IV
16049478|NCT02528877|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo hematopoietic stem cell transplant
16049479|NCT02528877|Other|Pharmacological Study|Correlative studies
16049480|NCT02528877|Drug|Ruxolitinib Phosphate|Given PO
16049481|NCT02528877|Drug|Sirolimus|Given PO
16049482|NCT02528877|Drug|Tacrolimus|Given IV or PO
16049568|NCT02528227|Other|Mimicking First Sounds Language Curriculum|Early language activity that parents can do with their infants
16049484|NCT02528825|Drug|Remifentanil titration|Initial concentration being 1.5ng/ml for the first patient The smooth emergence was defined as extubation without cough-a strong and sudden contraction of the abdomen. The predetermined concentration was decreased by 0.5 ng/ml for the next patient if the patient did not cough during emergence and similarly, if the patient coughed anytime during emergence, it was considered failed smooth emergence and predetermined concentration was increased by 0.5 ng/ml.
16049485|NCT02528812|Device|TheraBand Roller Massager|The roller massager was moved proximal to distal at a slow pace (2 seconds up and 2 second downs) over the muscle belly. Participants in the Sham group received very light pain-free cutaneous strokes of rolling massage with the same pace of rolling as performed for the Ipsi-R and Contra-R groups. The Control group did not receive any treatment.
16049486|NCT02528812|Other|Manual Massage|A massage therapist massaged the participant
16049487|NCT02528799|Biological|Nexvax2|Nexvax2 intra-dermal injections twice weekly
16049488|NCT02528799|Biological|Nexvax2 placebo|Sodium chloride 0.9% intra-dermal injections twice weekly
16049489|NCT02528786|Other|No Intervention|No study drug will be administered in this study.
16049490|NCT02528760|Drug|Metaclopramide|23. Metoclopromide to be given 10mg iv 8 hourly
16049491|NCT02528760|Drug|Erythromycin|Erythromycin to be given 70mg iv 12 hourly.
16049492|NCT02528760|Other|Placebo|
16049493|NCT02528721|Device|Dual Mode BreathID Hp System|The Dual Mode Breath ID Hp System consists of breath collection bags, a 13C-labelled substrate (urea) and a breath analyzer device
16049494|NCT02528708|Drug|fibrinogen concentrate|The dose of fibrinogen concentrate needed to achieve this target will be calculated using a formula that accounts for the baseline FIBTEM® - A10 value and the patient's body weight assessed at hospital admission . In general, a 70-kg patient requires a fibrinogen dose of approximately 0.5 g to increase the MCF by approximately 1 mm.
16049495|NCT02528708|Drug|Placebo|0.9% saline solution
16049496|NCT02528695|Radiation|18F-FDG PET/CT|18F-FDG PET/CT
16049497|NCT02528695|Device|euglycemic clamp|euglycemic clamp
16049498|NCT02528695|Device|hypoglycemic clamp|hypoglycemic clamp
16049499|NCT02528682|Biological|MiHA-loaded PD-L-silenced DC Vaccination|Eligible patients will receive one cycle of donor DC vaccination consisting of maximal 3 immunizations, given at 2 week intervals. PD-L1/L2-silenced, MiHA mRNA-electroporated donor DC will be infused intravenously (2.5x105/kg body weight).
16049500|NCT02528669|Device|RX Navigait|The RX Navigait is an accelerometer that tracks the number to steps taken, duration of walking, and time of walking. In addition, this device sends messages to patients regarding daily walking goals and walking reminders.
16049501|NCT02528656|Device|Vacuum Bell|Patients will be submitted to a negative pressure treatment with the Vacuum Bell device.
16049502|NCT02528656|Device|Dynamic Compression System|Patients will be submitted to a dynamic compression system.
16049503|NCT02528643|Drug|enzalutamide|Participants received 160 mg enzalutamide oral capsules (4 x 40 mg capsules) one daily.
16049504|NCT02528643|Drug|placebo|Participants received placebo to match enzalutamide oral capsules once daily.
16049505|NCT02528630|Other|Progressive resistance strength training program|Patients undergo to strength training for intrinsic muscles of the hand twice a week, during 12 weeks.
16049506|NCT02528630|Other|Joint protection and energy conservation advice|A session regarding joint protection and energy conservation for hands was done before randomization.
16049507|NCT02528617|Drug|Velaglucerase alfa|Enzyme replacement therapy
16049508|NCT02528604|Procedure|Catheter ablation|Left atrial ablation of persistent atrial fibrillation and implantable loop recorder insertion.
16049509|NCT02528604|Procedure|Pacemaker and AV node ablation|Permanent pacemaker implant followed by AV node ablation
16049510|NCT02528604|Procedure|DC Cardioversion|Electrical cardioversion for Persistent Atrial Fibrillation and implantable loop recorder insertion.
16049511|NCT02528604|Device|Implantable loop recorder|
16049512|NCT02528591|Device|oscillometric device (Arteriograph®, Medexpert)|Central blood pressure recorded in the non-fistula arm using a validated oscillometric device (Arteriograph®, Medexpert).
16049513|NCT02528578|Device|thermal stimulation delivered by a thermode.|Empathetic context (neutral, empathetic, non-empathetic) when thermal stimulation
16049514|NCT02528578|Other|functional MRI|MRI realised with thermal stimulations and empathetic context (neutral, empathetic, non-empathetic) when thermal stimulation
16049515|NCT02528565|Device|Adhesix Bioring|
16049516|NCT02528552|Device|LH80 PRO|
16049517|NCT02528552|Device|Sham Device|
16049518|NCT02528539|Other|ITP|"The study participants will receive weekly acupuncture treatment plus education on self-management for 10 weeks after axillary node dissection, then a total of five follow up acupuncture treatments once every 3 months at 6, 9, 12, 15, and 18 months. The education and self management will be reinforced monthly by telephone visit.
~Acupuncture points include: LI 4, LV3, HT3, SP9, GB 20, KD 3, Yintang, and Ashi points"
16049519|NCT02528526|Drug|OXY111A|OXY111A intravenous infusion
16049520|NCT02528513|Drug|midazolam|Midazolam is started with an infusion bolus of 0.03-0.30 mg/kg and continuous infusion of 0.03-0.20 mg/kg/h, with the dosage adjusted to RASS score (-3 to 0).
16049521|NCT02528513|Drug|Fentanyl|Fentanyl is used with bolus dosage of 1-2ug/kg and maintenance dosage of 1-2ug/kg/h, with the dosage adjusted to critical care pain observation tool（CPOT）score(0-1).
16049522|NCT02528513|Drug|propofol|After the spontaneous breathing trial safety screen is passed, midazolam is switched to propofol, which is administered at the maintenance dosage of 0.50-3.00mg/kg/h, with the dosage adjusted to RASS score (-2 to 0).
16049523|NCT02528513|Drug|Dexmedetomidine|After the spontaneous breathing trial safety screen is passed, midazolam is switched to dexmedetomidine, which is administered at an infusion bolus of 0.5μg/kg over 10 min (given or not according to patients' condition) and the maintenance dosage of 0.2-0.7ug/kg/h, with the dosage adjusted to RASS score (-2 to 0).
16049524|NCT02528513|Procedure|Procedure:sedation assessment|The nursing staff continuously monitored the sedation depth and adjusted the dosages of sedative and analgesic drugs to maintain the sedation target level. The sedation depth were assessed and recorded every 4 h (or more frequently when indicated).
16049525|NCT02528513|Procedure|Procedure:Weaning|the respiratory therapists managed patients with a daily interruption of continuous sedation and the spontaneous breathing trial (SBT) protocols daily.
16049526|NCT02528513|Drug|midazolam(used for passing the SBT safety screen)|After the spontaneous breathing trial safety screen is passed,in the midazolam group, midazolam will continue to be used for sedation, with the dosage adjusted to RASS score (-2 to 0).
16049527|NCT02528500|Device|GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis|Non-randomized, multicenter study designed to assess the initial feasibility of the GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis (TAMBE Device)
16049528|NCT02528474|Device|balloon angioplasty with Pantera Lux|Patient will be considered to be enrolled if ISR in DES was found by angiography. After randomization, patients will be treated with Pantera Lux for treatment of ISR. OCT will be performed just after balloon angioplasty for ISR lesion. Information will be collected and recorded on the treated study vessel including angiographic and OCT parameters. Follow-up OCT at 9 month will be performed.
16049529|NCT02528474|Device|balloon angioplasty with SeQuent Please|Patient will be considered to be enrolled if ISR in DES was found by angiography. After randomization, patients will be treated with SeQuent Please for treatment of ISR. OCT will be performed just after balloon angioplasty for ISR lesion. Information will be collected and recorded on the treated study vessel including angiographic and OCT parameters. Follow-up OCT at 9 month will be performed.
16049530|NCT02528461|Drug|Galactose|A test to investigate the liver's ability to metabolize galactose to glucose by injecting galactose followed by measurements of blood glucose and the quantification of galactose in the urine.
16049531|NCT02528461|Procedure|Gastroscopy|
16049532|NCT02528461|Procedure|Liver biopsy|
16049533|NCT02528461|Procedure|Fibroscan|
16049534|NCT02528461|Procedure|Liver vein catheterization|
16049535|NCT02528461|Drug|Sofosbuvir|
16049536|NCT02528448|Drug|Plasma-lyte|Continuous 1 hour infusion of plasma-lyte 15 micrograms/kg/hour for the first hour then 5 micrograms/kg/hour + amount needet for blood replacement
16049537|NCT02528448|Drug|0,9% saline|Continuous 1 hour infusion of 0,9% saline 15 micrograms/kg/hour for the first hour then 5 micrograms/kg/hour + amount needet for blood replacement
16049538|NCT02528422|Drug|Acyl-Ghrelin|
16049539|NCT02528409|Drug|Vortioxetine|Medication currently approved for major depression.
16049540|NCT02528409|Drug|Placebo|
16049541|NCT02528396|Drug|BioChaperone insulin lispro|Injection at t0,or t+15 minutes or t-15minutes with test meal
16049542|NCT02528396|Drug|Humalog®|Injection at t0,or t+15 minutes or t-15minutes with test meal
16049543|NCT02528383|Behavioral|Vagifem|"Women participating in the study will undergo clinical assessments, blood work and complete the quality of life questionnaire at baseline, 6 weeks and 12 weeks study time points. The following will be assessed:
~Effect of low dose Vagifem, 10ug tablet on vaginal atrophy.
~Effect of low dose Vagifem, 10ug tablet on sex hormones and bone health biomarkers.
~Impact of treatment on quality of life"
16049544|NCT02528370|Device|telEPOC|The program consisted of: 1) Educational program about COPD. This educational program was carried-out by a respiratory nurse in two 30-minute speeches to the patient and career, once at their inclusion in the program and again 1 year later. 2) Training in using the device (smart phone) that supported the telemonitoring. 3) Daily phone calls to make self-confident the patient during the first week. Afterwards the phone calls were established according to the capacity of the patient to manage on their own.
16049545|NCT02528357|Drug|GSK3174998|Lyophilized powder 40 mg reconstituted to get a dose range of 0.003 to <=10 mg/kg to be given as IV infusion for 30 minutes (min), Q3W
16049546|NCT02528357|Drug|Pembrolizumab|Pembrolizumab as 100 mg/4 milliliter (mL) solution (dose: 200 mg) to be given as IV infusion for 30 min, Q3W
16049547|NCT02528344|Behavioral|HIIT|All participants will undergo high intensity interval training 3x/week for 10-12 weeks. Intense exercise will be interspersed with appropriate rest periods of low intensity exercise
16049548|NCT02528331|Device|Transcranial magnetic stimulation|
16049549|NCT02528331|Behavioral|Cognitive behavioral therapy|
16049550|NCT02528318|Combination Product|Lucinactant for inhalation|Lucinactant for inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
16049551|NCT02528318|Device|nCPAP alone|nCPAP therapy
16049552|NCT02528305|Other|High-intensity Interval Training|2 minute warm-up at 50rpm, then increase to 100rpm. Weight added to bike (7% body weight for men 6% body weight for women). Continue effort for 6 seconds, then passive rest for at least 1 minute. Total 5 sprints in sessions 1-3, 6 sprints in session4, 7 sprints in sessions 5&6, 8 sprints in sessions 7&8, 9 sprints in sessions 9&10 and 10 sprints in sessions 11&12.
16049553|NCT02528292|Procedure|Synovial biopsy|Ultrasound guided synovial biopsy of inflamed joint
16049554|NCT02528292|Drug|Anti-TNF therapy|Therapy will include, but not limited to Etanercept, Certolizumab Pegol, Adalimumab and Infliximab
16049555|NCT02528279|Drug|Coartem|"Patients will receive the study drug combination artemether-lumefantrine (Coartem®) orally as a 6 dose regimen for three consecutive days. Tablets are available as a fixed dose combination of 20mg artemether plus 120mg lumefantrine. The dosing will be based on the body weight and follow the manufacturer's recommendations:
~Body weight 5-14kg: 1 tablet; Body weight 15-24kg: 2 tablets; Body weight 25-34kg: 3 tablets; Body weight > 34kg: 4 tablets; The respective amount of tablets is to be taken at hours 0, 8, 24, 36, 48 and 60 with fatty food."
16049556|NCT02528266|Device|Nerve Capping Device|
16049557|NCT02528253|Biological|Placebo to Week 16; tanezumab 5mg SC|Placebo SC injection every 8 weeks for 2 injections followed by tanezumab 5 mg injection every 8 weeks for 5 injections
16049558|NCT02528253|Biological|Placebo to Week 16, tanezumab 10 mg SC|Placebo SC injection every 8 weeks for 2 injections, followed by tanezumab 10 mg SC injection for 5 injections
16049559|NCT02528253|Biological|Tanezumab 5 mg SC|Tanezumab 5 mg SC
16049560|NCT02528253|Biological|Tanezumab 10 mg SC|Tanezumab 10 mg SC
16049561|NCT02528253|Biological|Tramadol PR oral|Tramadol PR oral
16049562|NCT02528240|Procedure|EMS|
16049563|NCT02528240|Device|+ occlusive membrane|
16049564|NCT02528240|Device|conebeam CT|
16049565|NCT02528227|Other|Know Your Baby Language Curriculum|Early language activities that parents can do with their infants
16049566|NCT02528227|Other|Reading Aloud Language Curriculum|Early language activity that parents can do with their infants
16049567|NCT02528227|Other|Sing A Long Language Curriculum|Early language activity that parents can do with their infants
16049573|NCT02528227|Other|Back to Sleep/SIDS prevention|Part of Health and Safety Curriculum
16049574|NCT02528227|Other|Taking a Temperature and Signs of Infection|Part of Health and Safety Curriculum
16049575|NCT02528227|Other|Infection Control Measures and Vaccine Information|Part of Health and Safety Curriculum
16049576|NCT02528214|Drug|Dupilumab|Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.
16049577|NCT02528214|Drug|Placebo|Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.
16049578|NCT02528214|Drug|Oral corticosteroid therapy (prednisone/prednisolone)|Oral administration.
16049579|NCT02528214|Drug|Inhaled corticosteroid (ICS) therapy|Oral inhalation, stable dose (high dose) of ICS in combination with up to 2 other controller medicines (second or third controller therapy).
16049580|NCT02528214|Drug|Albuterol/Salbutamol|Oral inhalation as needed.
16049581|NCT02528214|Drug|Levalbuterol/Levosalbutamol|Oral inhalation as needed.
16049582|NCT02528201|Drug|Celecoxib 200 milligrams|Celecoxib 200 milligrams once a day
16049583|NCT02528201|Drug|Celecoxib 400 milligrams|Celecoxib 400 milligrams once a day
16049584|NCT02528201|Drug|diclofenac 50 milligrams|diclofenac 50 milligrams three times a day
16049585|NCT02528188|Drug|NSAID|Orally administered NSAID (naproxen 500 mg, celecoxib 100 mg or diclofenac 75 mg) twice daily for 56 weeks
16049586|NCT02528188|Biological|Tanezumab 2.5 mg|Subcutaneous injection of tanezumab 2.5 mg every 8 weeks for 56 weeks
16049587|NCT02528188|Biological|Tanezumab 5 mg|Subcutaneous injection of tanezumab 5 mg every 8 weeks for 56 weeks
16049588|NCT02528175|Device|Magnetic resonance-guided focused ultrasound|Targeted warming of the tumor via 3 weekly MR-guided ultrasound procedures. Concurrent with radiation and chemotherapy.
16049589|NCT02528175|Radiation|Standard Radiation|30.6 Gray (Gy) over 17 fractions concurrent with chemotherapy (institutional standard).
16049590|NCT02528175|Drug|Chemotherapy|3.5 weeks concurrent with radiation therapy (institutional standard).
16049591|NCT02528162|Behavioral|education|Evaluation of education for GDM
16049592|NCT02528149|Procedure|tissue of adjacent part and aneurysm of renal aneurysm|the samples are collected during surgery of renal artery aneurysms. Th tissue is cryopreserved in liquid nitrogen before analysis
16049593|NCT02528149|Other|blood sample|
16049594|NCT02528136|Drug|Carbetocin|
16049595|NCT02528136|Drug|Oxytocin|
16049596|NCT02528123|Procedure|Small incision lenticule extraction|The VisuMax femtosecond laser is used to create two interfaces that define a refractive lenticule of stromal tissue and a 2mm wide tunnel to connect the upper layer to the corneal surface. The lenticule is manually dissected and removed through the small 2mm incision without the need to create a flap as in LASIK.
16049597|NCT02528123|Drug|Tobramycin and dexamethasone|Tobramycin and dexamethasone (Tobradex) eye drops will be used four times a day for 1 week after the procedure
16049598|NCT02528123|Drug|Ofloxacin|Ofloxacin (Exocin) eye drops will be used four times a day for 1 week after the procedure
16049599|NCT02528123|Drug|Proxymetacaine 0.5%|Proxymetacaine 0.5% eye drops will be used as an anaesthetic during the procedure
16049600|NCT02528123|Drug|Oxybuprocaine 0.4%|Oxybuprocaine 0.4% eye drops will be used as an anaesthetic during the procedure
16049601|NCT02528110|Procedure|Hyperthermic intraperitoneal chemotherapy (HIPEC)|Normal saline 3000ml-4000ml, Paclitaxel 75mg/m2, 5-Fu 15mg/m2, 43°C, 60min.
16049602|NCT02528110|Procedure|D2 radical gastrectomy|radical gastrectomy with D2 lymphadenectomy
16049603|NCT02528110|Other|SOX postoperative chemotherapy|Oxaliplatin 130mg/m2 d1, Tegafur,Gimeracil and Oteracil Porassium Capsules 60mg, d1-14.
16049604|NCT02528110|Other|XELOX postoperative chemotherapy|Oxaliplatin 130mg/m2 d1, Capecitabine 1000mg/m2 d1-14.
16049605|NCT02528097|Drug|Standard Care|Standard Care: 25% salt poor albumin administered day 1 (1.5g/kg) and day 3 (1.0g/kg)
16049606|NCT02528097|Drug|Experimental|25% salt poor albumin administered per standard care on day 1 (1.5g/kg). Second dose administered on day 2 or later only to those individuals with renal insufficiency and risk for renal failure (Cr > 1.0 or BUN or Cr > baseline)
16049607|NCT02528084|Procedure|yoga|patients watch and follow an online yoga video.
16049608|NCT02528084|Procedure|standard exercises|patients watch and follow an online standard exercises video.
16049609|NCT02528071|Other|Diaphragmatic endurance test|This consists of hyperventilation in a flask while maintaining the constant level of Carbon Dioxide (CO2). The patient will realize hyperventilation to increasing levels of Maximum Minute Ventilation (MMV), corresponding to increasing levels of respiratory rate, until exhaustion
16049610|NCT02528058|Procedure|Vitrectomy with internal limiting membrane peeling|
16049611|NCT02528045|Procedure|Vitrectomy with scleral shortening|
16049612|NCT02528032|Other|Echographic evaluation of heart function|Echocardiographic data collection and analysis, not fully exploited at present
16049613|NCT02528019|Drug|DPP-4 inhibiotors|
16049614|NCT02528019|Drug|SGLT2 inhibitors|
16049615|NCT02528019|Drug|Glimepiride|
16049616|NCT02528006|Device|Type 2 Thyroplasty using Titanium Bridges|
16049617|NCT02527993|Drug|Glucobay (acarbose)|Se arm description
16049618|NCT02527993|Drug|Januvia (sitagliptin)|Se arm description
16049619|NCT02527993|Drug|Verapamil HEXAL (verapamil)|Se arm description
16049620|NCT02527993|Drug|Victoza (liraglutide)|Se arm description
16049621|NCT02527993|Drug|Signifor (pasireotide)|Se arm description
16049622|NCT02527993|Device|Continuous glucose monitoring (CGM)|Continuous glucose monitoring will be performed during 6 days of the treatment period.
16049623|NCT02527993|Dietary Supplement|Meal tolerance test (MTT)|A meal tolerance test will be performed at the end of the treatment period. The subjects will consume the liquid meal at baseline and blood will be drawn for continuous blood sampling.
16049665|NCT02527629|Other|Decellularized human heart valves|Decellularized human aortic heart valves
16049666|NCT02527616|Device|FFR Infusion Microcatheter and standard intra-venous (IV) infusion|Cross-over design where FFR is measured twice in the same lesion using standard standard intra-venous (IV) infusion and new method
16049667|NCT02527603|Procedure|Boss-Holzach-Matter method|The patient holds both his hands around his knees in a supine position until the dislocated shoulder is reduced
16049624|NCT02527980|Other|No intervention: observation only|For all participants: We will conduct a 2-year longitudinal cohort study comprising participants who smoke exclusively CCs (n=175) and dual users of e-cigs and CCs (n=275). We will use state-of-the-art ecological momentary assessments to determine: 1) dynamic patterns of e-cig and CC use and related outcomes (e.g., dependence, withdrawal symptoms, CC quit attempts and quitting success); 2) episodic (affective, contextual, social) and stable person-factor (lifestyle factors, demographics) variables that covary meaningfully with e-cig and CC use and related outcomes; and 3) biomarkers of tobacco and carcinogen exposure as well as other health-related outcomes (e.g., reduced pulmonary function.
16049625|NCT02527941|Drug|Metronidazole|Participants will be provided with oral metronidazole 400mg po tid for one week, and followed up one month after treatment initiation.
16049626|NCT02527928|Other|None intervention|
16049627|NCT02527915|Other|Mental Health eConsults|Providers in primary care clinics who receive the intervention will be able to use electronic consultations (eConsults) with psychiatrists. If a primary care provider wishes to use eConsults, he/she will enter a specific question about a patient in the electronic medical record system and submit as an eConsult. A psychiatrist will review the question and the patient's record, and send a response back to the primary care provider within one business day.
16049628|NCT02527915|Other|Care as usual|Providers in primary care clinics will deliver care as usual to their patients.
16049629|NCT02527902|Device|Holter|measure of ANS in IgAN patients
16049630|NCT02527889|Other|Exercise training|8-week resistive exercise training
16049631|NCT02527876|Behavioral|High Intensity Interval Training|High Intensity Interval Training
16049632|NCT02527876|Behavioral|Moderate Intensity|Moderate Intensity Training
16049633|NCT02527876|Behavioral|Delayed Control|Delayed Control
16049634|NCT02527876|Device|FitBit Flex|Use to measure increase in Physical Activity
16049635|NCT02527863|Drug|Tolvaptan|60 mg Tolvaptan pr day for 1 day
16049636|NCT02527863|Drug|Placebo|1 tablet Unikalk pr day for 1 day
16049637|NCT02527850|Device|B-cure laser|
16049638|NCT02527837|Drug|Sodium nitrite|Sodium nitrite, 240 micrograms/kg/hour for 2 hours
16049639|NCT02527837|Drug|Sodium chloride|Sodium chloride, isotonic 0.9%, 25 ml/hour for 2 hours
16049640|NCT02527824|Drug|Oxaliplatin, Irinotecan, S-1|"Treatment will be delivered every 2 weeks
~Oxaliplatin 65 mg/m2 iv on day 1
~Irinotecan 135 mg/m2 iv on day 1
~S-1 80 mg/m2/day on day1-7"
16049641|NCT02527811|Drug|Ulinastatin|Ulinastatin will be diluted into saline solution and administered intravenously in the intraoperative and postoperative
16049642|NCT02527798|Drug|Furosemide Cohort 1|furosemide 1 mg/kg q 24 hours IV or 2 mg/kg q 24 hours enterally Cohorts will be enrolled sequentially after a safety review.
16049643|NCT02527798|Drug|Furosemide Cohort 2|furosemide 1 mg/kg q 6 hours IV or 2 mg/kg q 6 hours enterally Cohorts will be enrolled sequentially after a safety review.
16049644|NCT02527798|Drug|Furosemide Cohort 3|furosemide 2 mg/kg q 6 hours IV or 4 mg/kg q 6 hours enterally Cohorts will be enrolled sequentially after a safety review.
16049645|NCT02527798|Other|Placebo|Sugar water will be administered in a equivalent volume as drug intervention.
16049646|NCT02527785|Drug|Oxaliplatin, Irinotecan, S-1(OIS)|"Treatment will be delivered every 2 weeks
~oxaliplatin 65 mg/m2 iv on day 1
~irinotecan 135 mg/m2 iv on day 1
~S-1 80 mg/m2/day po on day 1-7"
16049647|NCT02527772|Drug|Liposomal Doxorubicin+Gemcitabine|Gemcitabine 1000mg/m2,d1,8,iv; Liposomal Doxorubicin 30mg/m2,d1,iv.q4w of each 28 day cycle. 6 of Cycles: until progression or unacceptable toxicity develops or Progressive Disease.
16049648|NCT02527772|Drug|FOLFOX4|Oxaliplatin 85 mg/m2 intravenously on day 1; Leucovorin 200 mg/m2 IV(in vein) from hour 0 to 2 on days 1 and 2; and Fluorouracil 400 mg/m2 IV bolus at hour 2, then 600mg/m2 over 22 hours on days 1 and 2, once every 2 weeks until progression or unacceptable toxicity develops or Progressive Disease.
16049649|NCT02527759|Behavioral|Survey|
16049650|NCT02527746|Biological|F-627|F-627 subcutaneous injection on Day 3 of each cycle for 4 cycles. Dose-escalation method was used.
16049651|NCT02527746|Drug|EC regimen|Epirubicin 100 mg/m2 (in vein) and Cyclophosphamide 600 mg/m2 (in vein) on Day 1 of each cycle for 4 cycles.
16049652|NCT02527733|Drug|Ranibizumab|
16049653|NCT02527733|Drug|Ranibizumab and laser|
16049654|NCT02527720|Behavioral|Mindfulness Therapy|BBMT is a simplified form of MM. Its core components are near resonance-frequency breathing (RFB), mindfulness training, positivity and inward attention. A key component in BBMT is to be mindful of breathing whenever possible, and breathe at near resonance frequency (RF), known as heart rate variability biofeedback. The human cardiovascular system is known to have resonance characteristics, with the first RF at ~0.1 Hz. RF varies between 4.5 and 7 cycles per minute. Breathing at RF stimulates the cardiovascular system to oscillate at that frequency at a very high amplitude and greatly stimulates the baroreflex system. RFB is known to reduce depression and stress symptoms as well as various diseases related to malfunction of the autonomic nervous system, such as asthma and hypertension.
16049655|NCT02527707|Drug|lonafarnib|antiviral farnesyltransferase inhibitor
16049656|NCT02527707|Drug|Ritonavir|CYP 3A4 inhibitor, lonafarnib booster
16049657|NCT02527694|Device|Flexible EMS stretcher cart|The flexible EMS stretcher cart is an innovative EMS stretcher cart built to be flexible to fit in smaller spaces such as elevators. The flexible stretcher bends at the hip joint as well as at the knee joint, so that the patient can be put in head-up position at 30 degrees elevation with elevated legs.
16049658|NCT02527694|Device|mechanical CPR|
16049659|NCT02527681|Drug|Ceftobiprole medocaril|Ceftobiprole medocaril was administered as a single intravenous infusion, with a bodyweight-adjusted volume, at a constant rate over 4 hours. The ceftobiprole dose was 7.5 mg/kg, which corresponds to 10.0 mg ceftobiprole medocaril.
16049660|NCT02527668|Dietary Supplement|Calcifediol|One capsule orally of Calcifediol (20 µg) per day with a meal for a duration of 6 months
16049661|NCT02527668|Dietary Supplement|Vitamin D3|One capsule orally of Cholecalciferol (3200 IU) per day with a meal for a duration of 6 months
16049662|NCT02527668|Other|Placebo|One capsule orally of a Placebo capsule per day with a meal for a duration of 6 months
16049663|NCT02527655|Behavioral|Choice-Based Physical Activity and Active Transportation|
16049664|NCT02527642|Other|embryo culture in buffered media|compare media that supports human embryo development in the laboratory (in vitro) using Time-Lapse system.
16049668|NCT02527603|Procedure|Spaso method|The physician holds the dislocated arm of the patient in a supine position and proceeds with gentle, soft movements of adduction, flexion and external rotation of the limb in this order until reduction is accomplished.
16049669|NCT02527603|Drug|Anti-Inflammatory Agents, Non-Steroidal|"All patients will be administered a dose of NSAI intra-muscular or orally (Dexketoprofen, Enantyum®) it is part of the normal treatment of these patients to cope with pain."
16049670|NCT02527590|Other|pneumatic stimulations(allodynic area)|2 series of 20 pneumatic stimulations (air jet) on a allodynic area for recording evoked potentials
16049671|NCT02527590|Other|pneumatic stimulations (healthy area)|2 series of 20 pneumatic stimulation on a healthy area (either contralateral or above or below allodynic area) will no pain triggering for recording evoked potentials
16049672|NCT02527590|Other|pneumatic stimulations no auditory masking|2 series of pneumatic stimulations (air jet) on the hand (without feeling pain) for recording evoked potentials
16049673|NCT02527590|Other|no stimulation (control)|no stimulation (control condition): air jet directed beside the hand
16049674|NCT02527590|Other|pneumatic stimulations with audidory masking|2 series of 20 pneumatic stimulations (air jet) on the hand (without feeling pain) with auditory helmet that totally masked the air jet noise.
16049675|NCT02527577|Drug|RopivacaIne chlorhydrate|3mg/kg injection Hour (H) 0, H12 ; H24, H36 ; H48
16049676|NCT02527577|Drug|Placebo|injection Hour (H) 0, H12 ; H24, H36 ; H48
16049677|NCT02527564|Drug|Suvorexant|
16049678|NCT02527564|Drug|Placebo|
16049679|NCT02527551|Other|Massage|6 weeks of deep haptic massage at 2 sessions of 30 minutes per week.
16049680|NCT02527538|Device|Pleth|apply the masimo probe on index fingertip and record the pleth variability and blood pressure during beach chair position
16049681|NCT02527525|Behavioral|Stepped Care|
16049682|NCT02527512|Drug|Povidone-Iodine|Chemical complex of polyvinylpyrrolidone (povidone, PVP) and elemental iodine
16049683|NCT02527512|Other|Normal Saline|Solution of 0.90% w/v of NaCl, 308 mOsm/L or 9.0 g per liter
16049684|NCT02527499|Behavioral|Ride-On Cars with Bimanual Training Program (ROCBT)|The car driving training includes 2 phases: I-car exploration and II-prompted driving. Participants can learn how to move and stop the car in the car exploration phase. Through prompted driving in phase II, they can use the car as a mean to explore environments (e.g., to the elevator, to different stores) and contact with people (e.g., drive to the caregiver and get the toy). Bimanual training involves activities which include perceptual motor tasks (e.g., smear both hands with color), holding and manipulative tasks (e.g., cutting toy vegetables or fruits), posture and balance (e.g., pull a cart), and self-care and activities of daily living (e.g., drinking water from a cup with two handles).
16049685|NCT02527499|Behavioral|Early Mobility Training Program|Most of the guidelines are similar with ROCBT, except for the bimanual training. The therapist and family will merely focus on independent mobility training and improving socialization. The training time and period is the same as ROCBT.
16049686|NCT02527499|Behavioral|Regular Therapy Program|The regular therapy group will continue the regular therapy, including physical, occupational and speech therapy. The general propose of the training is to improve the developmental scales, mobility, socialization and upper limb use in functional tasks. The research team will videotape the child's natural play and driving performance at the hospital for 1 hour/per session, 1 session/per week during the 9-week intervention phase.
16049687|NCT02527473|Other|Dispatcher-Assisted Basic Life Support CPR Education|"The training program focuses on working in a team with a dispatcher, re-enacting all steps during an emergency call from recognition of cardiac arrest to performing CPR.
~The one hour training session is split into four parts:
~Video self-instruction manikin practice (30 min), including a brief introduction to AED.
~Practice in pairs (15 min): Role-playing a simulated emergency scenario as the dispatcher and the rescuer
~Debriefing (15 min): Questions, answers and reflection
~Homework: Information leaflet handed out including at-home tasks such as operating the speakerphone function on the layperson's own phone"
16049688|NCT02527460|Drug|Anakinra|Participants will self-administer daily subcutaneous injections of anakinra for 8 weeks. The dose will be increased over the first four weeks to minimize injection site reactions. The target dose after four weeks is 300mg daily.
16049689|NCT02527434|Biological|Tremelimumab monotherapy|IV infusion
16049690|NCT02527434|Biological|MEDI4736 monotherapy|IV infusion
16049691|NCT02527434|Biological|MEDI4736 + tremelimumab combination therapy|IV infusion
16049693|NCT02527395|Other|Brief thermal sensitization|A small area of the skin of the study participants are heated to 45 degree celsius for 3 minutes, followed by evaluation of secondary hyperalgesia.
16049694|NCT02527395|Other|Pain during 1 min. thermal stimulation|A small area of the skin of the study participants are heated to 45 degrees celsius for 1 minute. During the 1 minute period, the study participant will continually report pain on an electronic visual analog scale.
16049695|NCT02527395|Other|Heat pain detection threshold|The threshold for heat pain are evaluated by heating a small area of the study participants skin. When the study participant feels pain, the temperature (degrees celsius) is registered. 4 threshold measurements per session. Heat pain threshold is defined as the average temperature of the 4 measurements.
16049696|NCT02527382|Procedure|Closed stump|Before cutting the bowel, a peritoneal sample for bacterial culture is taken from the peritoneal cavity (pelvic pouch). Anastomosis is performed while a bowel clamp is placed on the rectal stump. A second bacterial sample is obtained at the completion of the anastomosis from the same place (pelvic pouch) as the first one.
16049697|NCT02527369|Device|XP1100RF|Treatment of adipose tissue within the fat layer with XP1100RF device.
16049698|NCT02527356|Behavioral|Ride-On Cars with Standing Posture (ROC-Stand)|The 2-hour training session is composed of two 30-minute driving sessions and two 25-minute natural play sessions, with a 10-minute break. Every week's treatment program will be before planned and adjusted by the therapist and the caregivers through discussion and clinical observation of participant's performance in the previous session. Training will concentrate on building the concept of casual-effect on the switch and car motion, goal-oriented driving in a hospital, and upper limb use in functional tasks with driving and hand use in functional tasks for exploration in natural play session.
16049731|NCT02527122|Diagnostic Test|Allergen extracts|
16049732|NCT02527109|Drug|Nifedipine|
16050316|NCT02522871|Device|OCS™ Liver System|
16049699|NCT02527356|Behavioral|Ride-On Cars with Standing Postures (ROC-Sit)|Most of the guidelines are similar with ROC-Stand, except for the posture of driving. The training time and period is the same as ROC-Stand. The two 30-minute driving sessions can also be divided into 4 times of 15-minute sessions, depending on the child's standing ability with supported condition.
16049700|NCT02527356|Behavioral|Regular Therapy Program|The research team will ask caregivers to identify goals (before intervention), and measure progress using goal-attainment scaling (GAS). The regular therapy group will continue the regular therapy, including physical, occupational and speech therapy. In addition, they will receive training program in a hospital for 2 hours/per session, 2 sessions/per week for a total of 12-week intervention. The participants will also experience the two 30-minute car driving sessions during the whole 2-hour training. The difference between the regular therapy group and the two ROC groups is the experience of car driving is controlled by the therapist, i.e. passive locomotion. The general propose of the training is to improve the developmental scales, mobility, socialization and upper limb use in functional tasks. The research team will videotape the child's natural play and driving performance for 1 hour/per session, 1 session/per week during the 12-week intervention phase.
16049703|NCT02527330|Other|MR T2* imaging|Cardiac magnetic resonance imaging with T2* imaging
16049704|NCT02527317|Drug|Lipegfilgrastim|Investigate the incidence of treatment-related neutropenia following four cycles of dose dense (every 2 week) doxorubicin cyclophosphamide (AC) with lipegfilgrastim support (8 weeks).
16049705|NCT02527304|Radiation|Image-Guided Adaptive Radiation Therapy|Undergo adaptive staged SBRT
16049706|NCT02527304|Other|Quality-of-Life Assessment|Ancillary studies
16049707|NCT02527304|Other|Questionnaire Administration|Ancillary studies
16049708|NCT02527304|Radiation|Stereotactic Body Radiation Therapy|Undergo adaptive staged SBRT
16049709|NCT02527291|Other|Blood test|Blood test for CMV PCR and IL28
16049710|NCT02527278|Procedure|Laparoscopic tubal ligation|Female permanent birth control method performed via a surgical procedure
16049711|NCT02527278|Procedure|Hysteroscopic sterilization|Female permanent birth control method performed via placement of a device
16049712|NCT02527265|Biological|Afrezza|"Pharmaceutical form: powder
~Route of administration: inhalation"
16049713|NCT02527252|Other|Craniosacral therapy|
16049714|NCT02527252|Other|Classic Massage|
16049715|NCT02527239|Other|Prospective observational study|Prospective observational study collecting data during a clinic vist including measurement of respiratory muscle strength, respiratory failure, lung function, physical performance and blood testing for enzymes related to Pompe's disease and muscle function.
16049716|NCT02527226|Behavioral|Facial exercises|A series of self-administered facial movements and expressions.
16049717|NCT02527213|Drug|Sodium thiosulfate|Additional treatment(s) due to lesion progression When intervention occurs, the date of the intervening event should be recorded in the source documents and the (CRF). The subject should continue in the study as scheduled.
16049718|NCT02527213|Drug|Placebo|Additional treatment(s) due to lesion progression When intervention occurs, the date of the intervening event should be recorded in the source documents and the (CRF). The subject should continue in the study as scheduled.
16049719|NCT02527200|Drug|liraglutide|Injected s.c./ subcutaneously (under the skin) This trial consists of a part A and a part B. Part A of the trial is conducted in obese adolescents with PWS. Part B of the trial is conducted in obese children with PWS. Entry into part A and part B of the trial will be sequential.
16049720|NCT02527200|Drug|placebo|Injected s.c./ subcutaneously (under the skin) This trial consists of a part A and a part B. Part A of the trial is conducted in obese adolescents with PWS. Part B of the trial is conducted in obese children with PWS. Entry into part A and part B of the trial will be sequential.
16049721|NCT02527187|Biological|Betula verrucosa allergen extract|Four concentrations of Betula verrucosa allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.
16049722|NCT02527174|Drug|Volasertib|Addition of single dose of volasertib intravenously (IV) on Day 4 of treatment protocol.
16049723|NCT02527174|Drug|Idarubicin|Given IV daily on Days 1-3 of treatment protocol.
16049724|NCT02527174|Drug|Cytarabine|Given IV daily as 24-hour continuous infusion on Day 1-7 of treatment protocol.
16049725|NCT02527161|Device|ShapeMatch Cutting Guides with Triathlon|All participants will undergo medical imaging assessment using Magnetic Resonance Imaging (MRI) of the affected lower limb.These images will be used to manufacture the patient-specific cutting guides for preparation of the bones prior to implantation of the total knee replacement (Pre-operatively). Patients will undergo primary total knee arthroplasty with the Triathlon® Total Knee System (Stryker Orthopaedics, Mahwah, NJ USA) using the Shapematch cutting guides to guide the bone resection. Patients will follow the standard postoperative rehabilitation program established by the investigator at each site.
16049726|NCT02527148|Device|OtisMed® ShapeMatch® Technology|The appropriate Stryker ShapeMatch® Cutting Guides will be used to guide the surgeons bone resections. The surgeon will implant the knee prostheses following the surgical protocol for Triathlon® Knee System with OtisMed® ShapeMatch® Technology
16049727|NCT02527148|Device|Stryker Precision Knee Navigation|Stryker PrecisioN Knee (4.0) Navigation System, comprising of computer hardware and software and associated instrumentation, will be used for intra-operative alignment and orientation of implant. Navigation trackers will be secured to the femur and tibia and registration of the limb will be undertaken according to the PrecisioN Knee System surgical technique.Femoral and tibial resections, followed by device implantation, will be performed according to the Triathlon Knee System Surgical Protocol.
16049728|NCT02527148|Procedure|Total Knee Replacement|
16049729|NCT02527148|Device|Stryker Triathlon® Total Knee System|"Prosthetic components to be implanted including
~Triathlon® Cruciate Retaining (CR) Total Knee System (cemented), including Femoral Component and Primary Tibial Baseplate;
~Triathlon® Cruciate Substituting (CS) X3® polyethylene insert;
~Triathlon® X3 Patella (asymmetric) - treated selectively by surgeon."
16049730|NCT02527135|Behavioral|Weekly HIV sensitization text messages|"Weekly HIV sensitization text messages with option to text back up to 3 times per week for additional messages. Message topics included pregnancy, condoms, sexually transmitted infections, contraceptives, anal sex and personal risk of HIV. All messages ended with the phrase Get tested for HIV."
16049733|NCT02527096|Drug|dolutegravir (Tivicay®) - Phase 1|• Phase 1 (8 weeks) : switch of the third agent with dolutegravir(Tivicay®) 50 mg once a day.
16049734|NCT02527096|Drug|lamivudine (Epivir®) - Phase 2|• Phase 2 (48 weeks): combination with lamivudine (Epivir®) 300 mg once a day + dolutegravir (Tivicay®) 50 mg once a day. Only participants with plasma HIV RNA ≤ 50 cp/mL at Week 8 will continue on phase 2.
16049735|NCT02527096|Drug|dolutegravir (Tivicay®) - Phase 2|• Phase 2 (48 weeks): combination with lamivudine (Epivir®) 300 mg once a day + dolutegravir (Tivicay®) 50 mg once a day. Only participants with plasma HIV RNA ≤ 50 cp/mL at Week 8 will continue on phase 2.
16049736|NCT02527083|Drug|Propofol|
16049737|NCT02527083|Drug|Sevoflurane|
16049738|NCT02527083|Drug|Remifentanil|
16049739|NCT02527083|Drug|Ketamine|
16049740|NCT02527070|Device|RESPeRATE (Paced Breathing)|The subjects will be guided by a digital metronome to breath at 15, 10, and 6 breaths/min for 2 minutes each using the metronome function of the device RESPeRATE (InterCure, Israel) that guides breathing using musical tones played at selectable rhythm.
16049741|NCT02527070|Device|Quantum Warp10 (Red LED)|
16049742|NCT02527070|Device|Omnilux new-U (Near Infrared LED)|
16049743|NCT02527070|Other|Heat/cold provocation|Immersion of one foot in a warm water bath ( 43-45 degrees C) for few seconds and then immersion of the same foot in cold water bath (5-7 degrees C) for 1 min.
16049744|NCT02527057|Device|DW-MRI|Participants will perform four DW-MRI scanning as follows,before chemoradiation , at 2 weeks , 4 weeks after the start of radiotherapy and before the surgery.If participants can not receive surgery,the last scanning time will replaced at the end of radiotherapy.
16049745|NCT02527044|Procedure|Fractional Flow Reserve (FFR)|An FFR will be performed pre-operative to the CABG procedure
16049746|NCT02527031|Other|ECMO Insertion on pre hospital setting|ECMO Insertion on pre hospital setting
16049747|NCT02527031|Other|In Hospital ECMO|ECMO Insertion on in hospital setting for a refractory cardiac arrest
16049748|NCT02527018|Device|Sphygmomanometer|Non-invasive reliable method of continuous measuring arterial blood pressure in pregnant women. Nextfin provides continuous blood pressure, heart rate, cardiac output, stroke volume, systemic vascular resistance and left ventricular contractility indices.
16049749|NCT02527005|Drug|Sulphadoxine-pyrimethamine|Sulphadoxine-Pyrimethamine 500mg of Sulphadoxine and 25mg of Pyrimethamine 3tablets monthly for 3 doses
16049750|NCT02527005|Drug|Azithromycin|Tabs Azithromycin 500mg daily for 3 days
16049751|NCT02526992|Device|HR-pQCT|HR-pQCT (High Resolution peripheral micro Computerized Tomography) is a device used for 3D bone measurements at radius levels in humans.
16049752|NCT02526979|Drug|mirabegron|oral
16049753|NCT02526966|Biological|blood sample|dosage of anti-hinge region antibodies
16049754|NCT02526953|Drug|Paclitaxel|45 mg/m2, IV, weekly during the radiation. Number of infusions: 5.
16049755|NCT02526953|Drug|Capecitabine|625 mg/m2, bid, per os, only on days of radiation (Monday through Friday)
16049756|NCT02526953|Drug|Capecitabine|825 mg/m2, bid, per os, only on days of radiation (Monday through Friday)
16049757|NCT02526953|Drug|Mitomycins|10 mg/m2, IV, on day 1. Number of infusions: 1.
16049758|NCT02526953|Drug|Mitomycins|12 mg/m2, IV, on day 1. Number of infusions: 1.
16049759|NCT02526953|Radiation|Radiotherapy|Dose: 44 Gy on regional nodes, 52-58 Gy on primary tumor, based on T stage
16049760|NCT02526940|Procedure|rectal biopsies|6 rectal biopsies
16049761|NCT02526940|Other|Blood samples|Blood samples
16049762|NCT02526927|Device|HR-pQCT|The Xtrem CT scanco device is a HR-pQCT used for 3D bone measurements at the tibia and the radius levels in human
16049763|NCT02526927|Device|DEXA|The Lunar DEXA (Dual Energy X-ray Absorptiometry) is a third generation multi-captor DEXA device that allows short duration measurements (< 15 min). It measures Bone Mineral Density at the spine (L1-L4) and the femoral neck
16049764|NCT02526927|Other|Blood samples|
16049765|NCT02526914|Drug|Intranasal Oxytocin|Through the use of 2ml bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 24 IU Oxytocin. 5 puffs per nostril (1 puff = 2.5 IU Oxytocin).
16049766|NCT02526914|Drug|Intranasal vasopressin|Through the use of 2ml bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 20 IU vasopressin. 5 puffs per nostril (1 puff = 2 IU vasopressin).
16049767|NCT02526914|Drug|Intranasal placebo|Through the use of 2ml bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 5 puffs per nostril. Placebo consists of: di-sodium hydrogen phosphate, critic acid, sodium chloride, glycerin, benzalkonium chloride and aqua bidest.
16049768|NCT02526901|Other|No intervention|
16049769|NCT02526888|Drug|ACT-541468|Oral capsule (25 mg) as single dose
16049770|NCT02526888|Drug|Diltiazem|Two oral capsules (2 x 120 mg) once daily from Day 1 to Day 7
16049771|NCT02526875|Drug|Telminuvo®Tab. 40/2.5mg|per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg
16049772|NCT02526862|Device|Allevyn Thin®|Protection of the dermis with autoadhesive polyurethane dressing. The dressing will be standardized cut to avoid bias. The edges shape will be circular. They will be set in nasal bridge and cheekbones, avoiding frontal level. It will be checked every six hours, and if not properly fixed it will be applied again in the same way.
16049773|NCT02526862|Device|Askina Transorbent Border®|Protection of the dermis with semi-permeable hydrogel-foams adhesive dressing. The dressing will be standardized cut to avoid bias. The edges shape will be circular. They will be set in nasal bridge and cheekbones, avoiding frontal level. It will be checked every six hours, and if not properly fixed it will be applied again in the same way.
16049774|NCT02526862|Device|Linovera®|Protection of the dermis with hyper hydrogenated fatty acids. It will be applied with its doser and gently massaged in chin, cheekbones, nasal and frontal bridge as indicated in the product. It will be checked every six hours for proper hydration and if needed it will be applied again in the same way.
16049775|NCT02526849|Drug|Fecal microbiota transplantation (FMT)|Standardized Frozen Fecal Microbiota will be infused via nasointestinal tube.
16049776|NCT02526849|Behavioral|Conventional treatment|Conventional treatment was taken by both of two groups. If patients did not have a bowel movement for 3 or more consecutive days, they were permitted to take up to 20 g of Macrogol 4000 powder (Forlax®, Ipsen, Paris, France). If ineffective, an enema could be used.
16049819|NCT02526524|Drug|Met DR|metformin delayed-release tablets
16049777|NCT02526836|Procedure|Conventional Surgery|removal of the tumor with no ligation of the vessel centrally or removal of the whole mesocolon
16049778|NCT02526836|Procedure|Complete mesocolic excision with central vascular ligation|excision of the whole mesocolon plus ligation of the supplying blood vessel centrally
16049779|NCT02526823|Drug|R-CHOP/CHOPE or ABVD chemotherapy regimen|"R-CHOP:
~Rituximab：375mg/m2，ivgtt，D0； Epirubicin：70 mg/m2，ivgtt，D1 ； Cyclophosphamide：750 mg/m2，ivgtt，D1； Vincristine: 1.4 mg/m2 ivgtt，D1 ； Prednison：100mg/d，po，D1-5；
~CHOPE:
~Epirubicin：70 mg/m2，ivgtt，D1 ； Cyclophosphamide：750 mg/m2，ivgtt，D1； Vincristine: 1.4 mg/m2 ivgtt，D1 ； Prednison：100mg/d，po，D1-5； Etoposide: 100 mg/（m2•d），ivgtt，D1-3;
~ABVD:
~Epirubicin：35 mg/m2，ivgtt，D1、15； Bleomycin：10 mg/m2，ivgtt，D1、15； Vincristine：1.4 mg/m2，ivgtt，D1、15； Dacarbazine：375mg/m2，ivgtt，D1、15；"
16049780|NCT02526823|Drug|R-CDOP/CDOPE or DBVD chemotherapy regimen|"R-CDOP:
~Rituximab：375mg/m2，ivgtt，D0； PLD 30-40 mg/m2，ivgtt，D1 ； Cyclophosphamide：750 mg/m2，ivgtt，D1； Vincristine: 1.4 mg/m2 ivgtt，D1 ； Prednison：100mg/d，po，D1-5；
~CDOPE:
~PLD 30-40 mg/m2，ivgtt，D1； Cyclophosphamide：750 mg/m2，ivgtt，D1； Vincristine: 1.4 mg/m2 ivgtt，D1 ； Prednison：100mg/d，po，D1-5； Etoposide: 100 mg/（m2•d），ivgtt，D1-3;
~DBVD:
~PLD 15-20 mg/m2，ivgtt，D1； Bleomycin：10 mg/m2，ivgtt，D1、15； Vincristine：1.4 mg/m2，ivgtt，D1、15； Dacarbazine：375mg/m2，ivgtt，D1、15；"
16049781|NCT02526810|Drug|insulin lispro|continuous subcutaneous insulin injection( insulin lispro, Humalog) to reduce blood glucose in a certain level
16049782|NCT02526810|Drug|Insulin Glargine|long-acting insulin injection with metformin hydrochloride, Glucophage and gliclazide modified release tablets, Diamicron MR to reduce blood glucose in a certain level
16049783|NCT02526784|Drug|degarelix|
16049784|NCT02526771|Procedure|conventional lymph node dissection|conventional lymph node dissection during resection of intrahepatic cholangiocarcinoma
16049785|NCT02526771|Procedure|unconventional lymph node dissection|unconventional lymph node dissection during resection of intrahepatic cholangiocarcinoma
16049786|NCT02526758|Drug|beclomethasone|
16049787|NCT02526758|Drug|formoterol|
16049788|NCT02526758|Drug|budesonide|
16049789|NCT02526745|Biological|the vaccine with high doses of virus content between 4.7～5.0 lgPFU|
16049790|NCT02526745|Biological|the vaccine with low doses of virus content between 4.7～5.0 lgPFU|
16049791|NCT02526745|Biological|the vaccine with high doses of virus content between 4.3～5.0 lgPFU|
16049792|NCT02526745|Biological|the vaccine with middle doses of virus content between 4.3～5.0 lgPFU|
16049793|NCT02526745|Biological|the vaccine with low doses of virus content between 4.3～5.0 lgPFU|
16049794|NCT02526745|Biological|placebo|
16049795|NCT02526732|Other|individual training program|Training period of 8 weeks: Independently running exercises for 30-45 minutes two to three times a week. Every two weeks group training sessions are offered accompanied by a sports physician.
16049796|NCT02526719|Procedure|Nipple Delay surgery|The nipple delay surgery will be performed by the plastic surgeon as an outpatient procedure in the minor procedure room under local anaesthetic 7 - 21 days prior definitive NSM with IBR. The skin flap will be elevated in the plane of the prophylactic mastectomy beneath the NAC. A nipple core biopsy and a 1cm thick biopsy of immediately subareolar ductal tissue will be submitted for permanent section pathology. This approach is consistent with the previous case series of nipple delay for NSM and has been approved by the multi-disciplinary breast cancer team at our institutions. Patients that have a positive nipple core or sub-areolar biopsy will have the NAC removed at time of definitive mastectomy.
16049797|NCT02526706|Other|VisionBlue|VisionBlue is a staining solution designed to assist in making complete capsulorhexis during cataract surgery. The dye is injected into the anterior chamber via a paracentesis port and stains the anterior lens capsule, assisting in adequate visualization of the anterior lens capsule. This study proposes to explore the use of VisionBlue during cataract surgery as a means to assess functioning of an existing filtering bleb placed during prior trabeculectomy in patients with glaucoma.
16049798|NCT02526693|Diagnostic Test|Pupillometer|The Konan RAPDx (relative afferent pupillary defect) (Konan Medical USA, Irvine, CA) pupillometer utilizes digital, high-definition, infrared machine-vision with eye-tracking and automated blink detection technology to analyze and quantify pupillary response to light.
16049799|NCT02526680|Device|OrCam|The OrCam low vision aid, camera attached to glasses, used by 27 glaucoma subjects for 1 month.
16049800|NCT02526667|Drug|Chlorhexidine gluconate|2% CHG solution on cloth
16049801|NCT02526667|Drug|DynaHex-2|2% CHG solution
16049802|NCT02526667|Other|Vehicle|Excipients of CHG product only
16049803|NCT02526654|Diagnostic Test|Heidelberg Edge Perimeter|HEP measures peripheral vision
16049804|NCT02526654|Diagnostic Test|Octopus Visual Field|OVF measures peripheral vision
16049805|NCT02526654|Diagnostic Test|Optical Coherence Tomography|OCT measures retinal nerve fiber layer thickness
16049806|NCT02526641|Procedure|Functional Hepatic Nitrogen Clearance (FHNC)|
16049807|NCT02526641|Procedure|Galactose Elimination Capacity (GEC)|
16049808|NCT02526641|Procedure|Liver vein catheterization|
16049809|NCT02526615|Drug|Rosiglitazone|Patients received either placebo, metformin or rosiglitazone
16049810|NCT02526615|Drug|Metformin|Patients received either placebo, metformin or rosiglitazone
16049811|NCT02526615|Drug|Placebo|Patients received either placebo, metformin or rosiglitazone
16049812|NCT02526602|Procedure|Preservation (endopelvic fascia)|Robotic assisted radical prostatectomy with preserving of endopelvic fascia
16049813|NCT02526602|Procedure|Opening (endopelvic fascia)|Robotic assisted radical prostatectomy with opening of endopelvic fascia
16049814|NCT02526576|Biological|Stromal Vasular Fraction|The stromal vascular fraction obtained from adipose tissue will be added to the graft
16049815|NCT02526576|Procedure|Biopsy|A subgroup of each arm (2 subjects from each arm) will undergo a fat transfer behind each ear to be removed via biopsy after 12 months
16049816|NCT02526563|Procedure|ropivicaine|Blood draws to measure serum ropivicaine
16049817|NCT02526550|Biological|Live attenuated chimeric Japanese Encephalitis vaccine|0.5 mL dose containing ≥ 4.0 log10 plaque forming units (PFU) administered via the subcutaneous route into the left thigh
16049818|NCT02526550|Biological|Inactivated Hepatitis A vaccine|0.5 mL liquid dose for intramuscular injection administered via the intramuscular route into the right thigh
16049822|NCT02526511|Procedure|Arterial Spin Labeling Magnetic Resonance Imaging|Undergo arterial spin labeled perfusion magnetic resonance imaging
16049823|NCT02526511|Procedure|Dynamic Contrast-Enhanced Magnetic Resonance Imaging|Undergo dynamic contrast-enhanced perfusion magnetic resonance imaging
16049824|NCT02526511|Procedure|Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging|Undergo dynamic susceptibility contrast-enhanced perfusion magnetic resonance imaging
16049825|NCT02526511|Procedure|Perfusion Magnetic Resonance Imaging|Undergo perfusion magnetic resonance imaging
16049826|NCT02526498|Radiation|Accelerated Partial Breast Irradiation|Undergo accelerated partial breast irradiation (APBI) using high-dose rate (HDR) brachytherapy
16049827|NCT02526498|Radiation|High-Dose Rate Brachytherapy|Undergo APBI using HDR brachytherapy
16049828|NCT02526498|Other|Questionnaire Administration|Ancillary studies
16049829|NCT02526485|Procedure|Blood Draw|A one time blood draw of 150 milliliters will be performed using a vein in the participants arm. Existing venous access will be used for the blood draw in preference of new venipuncture.
16049830|NCT02526472|Procedure|ET under transabdominal US guidance (UGET)|When UGET was used, a second physician performed trans-abdominal US, and the embryos were discharged when the tip of the catheter was visualized approximately at 1,5 cm from the fundal endometrial surface
16049831|NCT02526472|Procedure|ET after transvaginal US uterine measurement (mTVET)|When mTVET was scheduled, the physician performed a transvaginal US scan just before ET, measured the length of the cervix and of the uterine cavity, and calculated the distance between the internal uterine os and the fundal endometrial surface. Then, ET was performed inserting the inner cannula in order to discharge embryos at a point obtained subtracting 1.5 cm from the total length of the cavity.
16049832|NCT02526459|Behavioral|Birth plan|Patient will receive a birth plan
16049833|NCT02526446|Behavioral|Self-administered acupressure|"The intervention consists of a total of 28 hours over a period of 8 weeks:
~i) Individual learning and practice: The training session will be one-on-one provided twice a week for two consecutive weeks (5 hours) in the participant's home.
~ii) Self-practice at home: From 3rd to 8th week, participant will engage in self-administered acupressure at home for 15 minutes twice a day for 6 weeks (21 hours).
~iii) Home follow-up: During the 3rd and 4th week (i.e. after the 2-week training session), a 1-hour home visit will be conducted for reinforcement of learning and self-practice by the same team of trainers once a week for 2 weeks (2 hours)."
16049834|NCT02526446|Other|wait-list control|The control group will receive a wait-list control condition (the same self-administered acupressure intervention but after the intervention group has completed the treatment condition).
16049835|NCT02526420|Drug|somavaratan|Long-acting recombinant human growth hormone therapy administered subcutaneously once monthly
16049836|NCT02526407|Behavioral|Singing|Sessions will be led by a professional practitioner assisted by students from the Royal College of Music. Participants will learn songs with their babies and help to create new musical material together.
16049837|NCT02526407|Behavioral|Group play|Sessions will be led by a professional practitioner assisted by students from the Royal College of Music. Participants will take part in group play activities.
16049838|NCT02526394|Biological|Meningococcal vaccine|Meningococcal vaccination
16049839|NCT02526394|Drug|Pertussis containing vaccine|Pertussis containing vaccination
16049840|NCT02526381|Drug|Danlou Tablets|Five tablets of Danlou Tablets (1.5g) will be given three times a day in addition to regular western medications for the 8 weeks
16049841|NCT02526381|Drug|Tongmai Yangxin Pills|Forty pills of Tongmai Yangxin Pills (4g) will be given two times a day in addition to regular western medications for the 8 weeks
16049842|NCT02526368|Drug|Pyruvate (13C)|Given IV
16049843|NCT02526368|Drug|Hyperpolarized 13C,15N2-urea|Given IV
16049844|NCT02526368|Procedure|Magnetic Resonance Spectroscopic Imaging|Undergo MRSI
16049845|NCT02526355|Behavioral|Mobile based intervention|Learning through Play Plus Intervention delivered through mobile phone
16049846|NCT02526342|Device|V.A.C. UltraTM (KCI®,San Antonio, Texas, USA)|Free muscle flaps are treated with Negative Pressure Wound Therapy (V.A.C. Ultra (KCI®,San Antonio, Texas, USA)) for five days following surgery with a continuous subatmospheric pressure of 125 mmHg.
16049847|NCT02526329|Biological|donor regulatory T lymphocytes|Given IV
16049848|NCT02526329|Other|laboratory biomarker analysis|Correlative studies
16049849|NCT02526316|Biological|P16_37-63 peptide combined with Montanide® ISA-51 VG|Patients will receive P16_37-63 peptide (100 µg) combined with Montanide® ISA-51 VG vaccination subcutaneously once a week for four weeks, followed by a 4 week rest period
16049850|NCT02526316|Biological|P16_37-63 peptide without Montanide® ISA-51 VG|Patients will receive 30 mcg P16_37-63 peptide injected intradermally for test on delayed-type hypersensitivity (DTH) reactions.
16049851|NCT02526303|Drug|Nadroparin Calcium and Warfarin|Warfarin (with nadroparin calcium at the first 5 days at least) until recanalization or 1 year
16049852|NCT02526290|Device|Intranasal Lacrimal Neurostimulator (Oculeve)|Neurostimulation device
16049853|NCT02526277|Device|MMF07 Foot Massager|
16049854|NCT02526277|Device|Heat Therapy|
16049855|NCT02526264|Other|Education program|Verbal education prior tu surgery administered to all patients in order to inform about the surgery and outcomes
16049856|NCT02526251|Other|observational|No intervention
16049857|NCT02526238|Device|TMS and trunk rotation|TMS and trunk rotation
16049858|NCT02526238|Device|Sham TMS and trunk rotation|Sham TMS and trunk rotation
16049859|NCT02526225|Drug|Ginkgo diterpene lactone meglumine injection|5 ml,oral,5 ml/times, 1 time/day.Before use, the drug slowly added to the 0.9% sodium chloride injection diluted in 250 ml, slow intravenous drip.
16049860|NCT02526225|Drug|Ginkgo diterpene lactone meglumine injection simulation|5 ml,oral,5 ml/times, 1 time/day.Before use, the drug slowly added to the 0.9% sodium chloride injection diluted in 250 ml, slow intravenous drip.
16049861|NCT02526212|Behavioral|G-BMT|The G-BMT intervention will include weekly group visits (for 8 weeks) where 5-10 patients simultaneously receive care from a multidisciplinary team of a generalist physician and a behavioral specialist. Group visits will last 90 minutes and include: BMT education, instruction on self-management skills, peer support, and individual medical management.
16049993|NCT02525328|Other|blood or saliva specimen|blood or saliva specimen is sampled for DNA extraction in CT family's members
16050317|NCT02522871|Other|Control|
16049862|NCT02526212|Behavioral|Treatment as usual|Primary care physicians who prescribe buprenorphine will be trained to follow a protocol of BMT intensification, which includes increased visit frequency, referral for mental health counseling, and referral to addiction treatment specialist.
16049863|NCT02526212|Drug|Buprenorphine|All participants will continue to receive maintenance treatment with buprenorphine-naloxone
16049864|NCT02526199|Drug|Bupivacaine|Sciatic nerve block
16049865|NCT02526199|Drug|Epinephrine|Adjuvant to perinerual block
16049866|NCT02526199|Drug|Dexamethasone|Adjuvant to perinerual block
16049867|NCT02526186|Device|Battlefield Auricular Acupuncture|
16049868|NCT02526173|Procedure|RALP using full nerve sparing technique|RALP using full nerve sparing technique
16049869|NCT02526173|Other|dHACM Application|2x12 sheet of dHACM applied to the neurovascular bundle
16049870|NCT02526160|Biological|burosumab|solution for SC injection
16049871|NCT02526160|Other|Placebo|saline solution for SC injection
16049872|NCT02526147|Other|Cash|
16049873|NCT02526147|Other|Voucher|
16049874|NCT02526147|Other|Food|
16049875|NCT02526134|Device|radio opaque markers (Echo Tip Ultra Fiducial Needle - ETUF)|
16049876|NCT02526121|Procedure|Phlebotomy|Volume of 400 mL every 3 weeks, 3 times.
16049877|NCT02526121|Behavioral|Dietary and lifestyle counseling.|Dietary and lifestyle counseling.
16049878|NCT02526108|Other|HIFT|Workout alternates short periods of intense exercise using varied, multiple-joint movements, with less-intense active recovery periods. Workout sessions will be led by a trained instructor.
16049879|NCT02526082|Other|Intervention|Multifactorial intervention with lifestyle changes and drugs as needed
16049880|NCT02526069|Behavioral|Acceptance and Commitment Therapy|An application based on Acceptance and Commitment Therapy
16049881|NCT02526056|Other|Physiotherapists|This study is a usability design with qualitative and quantitative aspects. The therapeutic relevance and design features will be explored.
16049882|NCT02526056|Other|elderly people|In one part, with patients, physical strain and designs facets will be investigated. During their game playing process, different measurements will be done. They will be asked about their opinions about the game.
16049883|NCT02526043|Procedure|laparoscopic hepatectomy|The HCC patients who meet the Louisville consensus will underwent liver resection by laparoscopy
16049884|NCT02526043|Procedure|Open hepatectomy|The HCC patients who meet the Louisville consensus will underwent liver resection by open surgery
16049885|NCT02526030|Drug|Aripiprazole|
16049886|NCT02526030|Drug|Quetiapine|
16049887|NCT02526030|Drug|Ziprasidone|
16049888|NCT02526017|Biological|FPA008|
16049889|NCT02526017|Biological|BMS-936558|
16049890|NCT02526004|Drug|Ceftazidime|
16049891|NCT02526004|Drug|Tobramycin|
16049892|NCT02525991|Device|Staccato® Delivery System Loxapine (ADASUVE®)|one dose Loxapine Staccato 9.1 mg
16049893|NCT02525978|Behavioral|Video Task|Subjects are asked to watch a series of six two-minute video clips. The video clips are designed to induce sad or happy emotions or no emotion (neutral) and are taken from movies, documentaries, or instructional videos. There are two videos for each emotion condition. Videos and fixation cross screens are viewed on a laptop computer. In between video clips, patients are asked to quietly look at a fixation cross for one minute, describe their emotional reaction to the video for up to one minute, then again attend to a fixation cross for one minute. A video recording of the frontal view of the participant's face will be made during task performance.
16049894|NCT02525978|Other|Imaginal Task|Subjects are asked to think about happy or sad memories for 2 minutes. Subjects are asked to imagine performing neutral tasks, such as buying groceries. Subjects are then asked to think about a memory that makes them feel angry. A video recording of the frontal view of the participant's face will be made during task performance.
16049895|NCT02525965|Procedure|Wide resection margin >1cm|Surgical removal of lesions choosing the method of wide resection margin >1cm
16049896|NCT02525965|Procedure|Narrow resection margin <1cm|Surgical removal of lesions choosing the method of wide resection margin <1cm
16049897|NCT02525952|Procedure|Hepatectomy|Surgical removal of all lesions
16049898|NCT02525952|Procedure|TACE|Transarterial chemoembolization with lipiodol and pirarubicin
16049899|NCT02525939|Drug|dalcetrapib|Cholesterol Ester Transfer Protein inhibitor
16049900|NCT02525939|Drug|Placebo|matching placebo tablets
16049901|NCT02525926|Procedure|denervation|The examination proceeds under rigorous aseptic technique. Femoral, jugular or brachial venous access will be performed. A flexible catheter is first introduced across a 7-Fr venous introducer, and passed through the right heart chambers toward the origin of the pulmonary arteries. The pressures in the right heart chambers and the pulmonary artery will be measured. At the end of the examination, the catheter is removed, a dressing is applied and the venous puncture is compressed by hand.
16049902|NCT02525926|Procedure|sham procedure|"Right heart catheterism is mandatory in PAH patients care (for diagnosis and during follow-up) and will serve as a  sham  procedure. A usually performed and after a venous punction, cardiac outpout and pulmonary artery pressures will be recorded.
~Acoustically isolated headphones will be given to patients during the procedure in order to assure simple-blind during the study."
16049903|NCT02525913|Device|RFA Applicator|
16049904|NCT02525900|Procedure|Wound Infiltration|Wound Infiltration with 0.25% Bupivacine
16049905|NCT02525900|Procedure|TAP Blocks|bilateral TAP block with 0.25% Bupivacaine
16049906|NCT02525900|Procedure|TAP Catheters|bilateral TAP Catheter with repeat bolus of 0.25% Bupivacaine
16049907|NCT02525887|Other|Observation|Observation and evaluation of care provided to patients that received DNA tests to determine metabolic pathways.
16049908|NCT02525874|Drug|dimethyl fumarate|Initial oral dose for 7 days with maintenance dose thereafter
16049909|NCT02525861|Biological|GLASSIA|Participants will receive weekly IV infusions of GLASSIA at 60 mg/kg BW active A1PI protein administered at a rate of 0.2 mL/kg/min for 25 weeks (25 planned infusions) via an IV administration.
16049910|NCT02525848|Drug|dexamethasone|dexamethasone 8 mg iv 2 minutes before induction of anesthesia
16049911|NCT02525848|Drug|Gabapentin|oral gabapentin 600 mg 1 hour before induction of anesthesia
16049912|NCT02525848|Drug|Aprepitant|oral aprepitan 80mg 1 hour before induction of anesthesia.
16049913|NCT02525835|Dietary Supplement|Low Dietary Sodium|Participants will be randomized to a low sodium diet (50 mmol/24 hours) for 28 days (range allowed 25-31 days) with a 4 week washout period between (range 2-3 weeks).
16049914|NCT02525835|Dietary Supplement|High Dietary Sodium|Participants will be randomized to a high sodium diet (250 mmol/24 hours) for 28 days (range allowed 25-31 days) with a 4 week washout period between (range 2-3 weeks).
16049915|NCT02525822|Drug|IDP-123 Lotion|Investigational Product: IDP-123 Lotion
16049916|NCT02525822|Drug|Tazorac Cream, 0.1%,|Comparator Product: Tazorac Cream, 0.1%
16049917|NCT02525822|Drug|Vehicle Cream|Comparator Product: Vehicle Cream
16049918|NCT02525822|Drug|Vehicle Lotion|Comparator Product: Vehicle Lotion
16049919|NCT02525809|Device|Novae E®|
16049920|NCT02525809|Device|Sunfit®|
16049921|NCT02525809|Device|Quartz®|
16049922|NCT02525796|Drug|eplerenone|eplerenone, titrated up to a maximum of 50mg BID
16049923|NCT02525796|Drug|amiloride|amiloride, titrated up to a maximum of 10mg BID
16049924|NCT02525796|Drug|Placebo|
16049925|NCT02525796|Drug|Cinacalcet|Cinacalcet, as add-on therapy in addition to eplerenone/amiloride/placebo, titrated up to a maximum of 30mg BID
16049926|NCT02525770|Device|radiostereometric analysis (RSA)|
16049931|NCT02525744|Drug|LY900014|Administered SC
16049932|NCT02525744|Drug|Insulin Lispro (Humalog)|Administered SC
16049933|NCT02525718|Drug|Saline|If randomized to this arm, subjects will receive an intraoperative injection of saline. (2.5 mg/ml)
16049934|NCT02525718|Drug|0.25 % bupivacaine (2.5 mg/ml) w/ 1:100,000 epinephrine & 4 mg dexamethasone|"If randomized to this arm, subjects will receive a selective block with a local anesthetic solution containing 0.25 % bupivacaine.
~(2.5 mg/ml) with 1:100,000 epinephrine and 4 mg dexamethasone intraoperatively."
16049935|NCT02525705|Biological|Oral Glucose|1.75g/kg of glucose is orally taken by the patient. Capillary glycemia is systematically realised before ingestion (H0) and after 30, 60, 90, 120, 180 and 240 min and/or if clinical signs of hypoglycemia are presented by the patient.
16049936|NCT02525692|Drug|ONC201|
16049937|NCT02525679|Drug|BI 655130|
16049938|NCT02525679|Drug|Placebo|
16049939|NCT02525653|Drug|albumin-bound paclitaxel|
16049940|NCT02525653|Drug|gemcitabine|
16049941|NCT02525640|Device|Hearing Aid|Hearing aid comparison
16049942|NCT02525627|Device|Trident cup, X3 inserts, 28 mm head|Orthopaedic implant
16049943|NCT02525627|Device|Trident cup, X3 inserts, 40 mm head|Orthopaedic implant
16049944|NCT02525627|Device|Symax stem|Orthopaedic implant
16049945|NCT02525627|Device|Accolade TMZF stem|Orthopaedic implant
16049946|NCT02525614|Device|Triathlon Standard Keel|Implantation of Knee Prosthesis
16049947|NCT02525614|Device|Triathlon Short Keel|Implantation of Knee Prosthesis
16049948|NCT02525601|Device|Triathlon CR cemented|Implantation of Knee Prosthesis
16049949|NCT02525601|Device|Triathlon CR uncemented|Implantation of Knee Prosthesis
16049950|NCT02525588|Device|Triathlon CS fixed bearing total knee prosthesis|The patient will receive either the N2Vac polyethylene inlay or the X3 polyethylene inlay for their CS total knee.
16049951|NCT02525575|Behavioral|Project Life Force Group Treatment|"PLF, a 12-session, group psychotherapy intervention, combines Dialectical Behavioral Therapy (DBT) skill based and psychoeducational approaches, to enhance suicide safety planning development and implementation. Veterans revise their plans over several weeks while learning distress tolerance, emotion regulation, and friendship building/interpersonal skills to incorporate into their safety plans and also receive lessons on gun safety and minimizing access to lethal means. Sessions are augmented with 1) training in the use of a suicide safety planning mobile App to promote accessibility and maximize implementation, and 2) didactic information to bolster recovery, including fostering improved connection with the treatment team, and Veteran's family. Importantly, the group format mitigates loneliness and fosters increased belongingness, both key risk factors for suicide."
16049952|NCT02525562|Device|Triathlon Total Knee System with X3 insert|Total knee replacement
16049953|NCT02525562|Device|Scorpio NRG Total Knee System with X3 insert|Total knee replacement
16049954|NCT02525562|Device|Triathlon PKR System with X3 insert|Partial Knee Resurfacing
16049955|NCT02525549|Drug|Adapalene and Benzoyl Peroxide Gel|
16049956|NCT02525549|Drug|Adapalene and Benzoyl Peroxide Gel (Reference)|
16049957|NCT02525549|Drug|Placebo gel|
16049958|NCT02525536|Drug|Trebananib 3 mg/kg|Trebananib (AMG 386) 3 mg/kg, intravenous infusion.
16049959|NCT02525536|Drug|Trebananib 10 mg/kg|Trebananib (AMG 386) 10 mg/kg, intravenous infusion.
16049960|NCT02525536|Drug|Trebananib 30 mg/kg|Trebananib (AMG 386) 30 mg/kg, intravenous infusion.
16049961|NCT02525523|Drug|Alicaforsen|
16049962|NCT02525523|Drug|Placebo|
16049963|NCT02525510|Other|Pump Eligible - Normothermia - Pump Both Kidneys|Normothermia and Machine Perfusion Deceased Donors will be kept normothermic (36.5-37.5 C) prior to organ recovery. Recovered kidneys will receive machine perfusion prior to implantation.OPO's protocol
16049964|NCT02525510|Other|Pump Eligible - Hypothermia and Pump Right Kidney|"Deceased Donors will be kept mildly hypothermic (34-35 C) for at least 12 hours prior to organ recovery. Right Kidney will receive machine perfusion prior to implantation and the Left Kidney will receive cold storage.
~Recovered kidneys will be placed in University of Wisconsin for cold storage until reimplantation."
16049965|NCT02525510|Other|Pump Eligible - Hypothermia and Pump Left Kidney|Deceased Donors will be kept mildly hypothermic (34-35 C) for at least 12 hours prior to organ recovery. Left Kidney will receive machine perfusion prior to implantation and the Right Kidney will receive cold storage.
16049966|NCT02525510|Other|Not Pump Eligible - Normothermia|"Deceased Donors will be kept normothermic (36.5-37.5 C) prior to organ recovery.
~Pulsatile Perfusion of kidney grafts based on the respective OPO's protocol"
16049967|NCT02525510|Other|Not Pump Eligible - Hypothermia|Deceased Donors will be kept mildly hypothermic (34-35 C) for at least 12 hours prior to organ recovery.
16049968|NCT02525497|Device|FM peritoneal dialysis machine|FM peritoneal dialysis machine APD 10L/10h
16049969|NCT02525497|Device|HOMECHOICE peritoneal dialysis machine|HOMECHOICE peritoneal dialysis machine APD 10L/10h
16049970|NCT02525484|Drug|Pirfenidone|Pirfenidone 801 mg single oral doses will be given either in the form of tablet or capsules under fed or fasted conditions on Days 1, 4, 7 and 10.
16049971|NCT02525471|Drug|RNS60|"RNS60 will be administered in two ways: by intravenous (IV) infusion one day a week (infusion dose: 375ml, infused over a 40-min period) and by inhalation (the remaining 6 days a week, 4 ml/day) for 23 weeks.
~In addition, subjects will be given the option to continue to receive drug for approximately an additional 24 weeks, for a total of approximately 48 weeks on study drug. Study drug will be given by intravenous (IV) infusion one day a week (infusion dose: 375ml, infused over a 40-min period) and by inhalation (the remaining 6 days a week, 4 ml/day) during the extension phase."
16049972|NCT02525458|Device|QAMS-containing PMMA|Wear retainer with QMAS-containing PMMA on one side of retainer
16049973|NCT02525458|Device|QAMS-free PMMA|Wear retainer with QMAS-free PMMA on other side of retainer
16049974|NCT02525445|Procedure|acupuncture|acupuncture was administered (sharp needles diameter 0.25 x length 40 mm) bilaterally to the acupuncture point pericardium six (PC6) between the tendons of palmaris longus and flexor carpii radialis at two body-inches (one body-inch approximately 1.5 cm) proximal to the wrist at 0.5 body-inch depth. The therapists manually manipulated the needles three times per treatment by rotating, thrusting or lifting the needles. When the participant reported a sense of numbness or soreness and the therapist noted a minimal muscular contraction around the needle.
16049975|NCT02525445|Procedure|sham acupuncture|"sham acupuncture was administrated (blunt needles diameter 0.25 x length 40 mm) bilaterally to a non-acupuncture point four body-inch proximal and one body-inch radial from the PC6 point, with the telescopic non-penetrating Park´s sham needle [20]. Park's credible needle looks identical to a real needle but glides upward into its handle, giving an illusion of penetration. A marking tube, identical for both acupuncture types, held the sham needle in place. The therapists manipulated the needles a few seconds three times per session until the needles touched the skin, but no needle sensation occurred, and then lifted the needles up from the skin."
16049976|NCT02525445|Procedure|positive communication|"During the acupuncture treatment the therapist conveyed, at least three out of several positive statements, such as: Many acupuncture studies have shown excellent results concerning relaxation effects, Brain imaging studies show that acupuncture treatments affect areas that affect pulse, blood-pressure and muscle tension."
16049977|NCT02525445|Procedure|neutral communication|"During the acupuncture treatment the therapists conveyed, at least three out of several neutral statements, such as: During treatment you will just lie down and rest and I will not talk so much to you, We don´t really know if acupuncture is a good method for relaxation effects; thus we need to perform this study,"
16049978|NCT02525432|Biological|Placebo Infusion|In addition to the standard of care provided to all patients with traumatic brain injury, subjects assigned to the placebo control group will undergo a sham bone marrow harvest and receive a placebo infusion of saline.
16049979|NCT02525432|Biological|Autologous BMMNC Infusion|In addition to the standard of care provided to all patients with traumatic brain injury, subjects assigned to the BMMNC treatment group will undergo a bone marrow harvest and then receive an autologous stem cell infusion.
16049980|NCT02525419|Behavioral|Weight Loss Phase|High Protein, Intermittent Fast, Low Calorie Diet
16049981|NCT02525419|Behavioral|HP-IF|High Protein, Intermittent Fast
16049982|NCT02525419|Behavioral|HH|Heart Healthy
16049983|NCT02525406|Other|All surgeries performed from Jan 01, 2010 to Aug 31, 2020|
16049984|NCT02525393|Device|tDCS|Stroke rehabilitation performed with the aid of a transcranial electrical stimulation device.
16049985|NCT02525393|Device|rTMS|Stroke rehabilitation performed with the aid of a repetitive transcranial magnetic stimulation device.
16049986|NCT02525393|Device|Sham|Stroke sham stimulation performed with the aid of a transcranial electrical stimulation device.
16049987|NCT02525380|Procedure|Device(DC Bead)|Doxorubicin-Eluting-Bead Embolization (DEBDOX), DC Bead are a novel drug delivery embolization system
16049988|NCT02525367|Behavioral|Online cognitive training|The intervention is a computerized, online training programme which aims to train several cognitive abilities; especially the executive functions, attention, working memory and processing speed. The mental processes that are appealed to by the intervention are similar to processes that are trained in classic face-to-face training methods. Both the intervention protocol and the active control condition will contain several games that have the participant train cognitive functions/perform cognitive activities for 8 weeks, 3 times a week, 45-60 minutes each session.
16049989|NCT02525367|Behavioral|Active control condition|The active control condition consists of cognitive activities that do not intend to train cognitive functions based on 'cristallized intelligence', such as trivia. Both the intervention protocol and the active control condition will contain several games that have the participant train cognitive functions/perform cognitive activities for 8 weeks, 3 times a week, 45-60 minutes each session.
16049990|NCT02525341|Other|Hatha yoga|A sequence of 8 - 10 core yoga poses, breathing and relaxation techniques were practiced in each yoga class, and 2 - 3 new poses were introduced progressively in each of the yoga session. Props such as blocks, blankets, belts, mats, and chairs were used during the session.
16049991|NCT02525341|Other|Aerobic and strengthening exercises|A 15 minute of gentle aerobic exercise and a 30 minute of strengthening program that includes both isometric (without moving the joints) and isotonic (moving the joints) exercises of the lower extremities were taught to the participants.
16049992|NCT02525341|Other|General education|One-time Arthritis Foundation educational brochures focusing on the disease process, diet and exercise and OA management education were given.
16049994|NCT02525315|Device|Transcranial magnetic stimulation: rTMS|4 sessions of 13 minutes, with 2 sessions a day, at 20Hz frequency and at an intensity of 80% of rest motor threshold will be delivered
16049995|NCT02525302|Drug|HT-100|HT-100 is Akashi Therapeutics' proprietary delayed-release formulation of halofuginone hydrobromide, a small molecule therapeutic with anti-fibrotic properties. May be administered in either fed or fasted state. Not mutation specific.
16049996|NCT02525289|Other|Bed Rotation Group|Patients received continuous lateral rotation by a mechanical device (Hill Rom Bed Rotation), consecutive cycles of to left and right side, plus supine position during 30 seconds for pause, in the first postoperative day until 48 hours. Additional breathing exercises.
16049997|NCT02525289|Other|Orthostatic Group|Patients were seated on the bed 6 hours post extubation for two hours. After, sitting in the bed with their feet on the floor for two minutes; standing up and walking in the place for two minutes, in the first 24 hours and 48 hours postoperative. Additional breathing exercises.
16049998|NCT02525276|Behavioral|exercise|The exercise intervention will conduct the following training program 4 days/week for 6 months: endurance training consisting of supervised training on a bike ergometer for 20 min at 70% of maximal heart rate (HR) the first week, increased by 5 min each week until reaching 40 min. Then the intensity will be increased to 80% of max HR over the next month and recalculated every month.
16049999|NCT02525276|Drug|Hormone treatment|"Continually estradiol and gestagens - tablets and patches or cyclic estradiol and gestagens - tablets or patches.
~Including:
~Drospirenon, Norethisteronacetat, Medroxyprogesteronacetat"
16050000|NCT02525263|Biological|Neo-Kidney Augment|NKA is made from expanded autologous selected renal cells (SRC) obtained from the patient's kidney biopsy. To manufacture NKA, kidney biopsy tissue from each enrolled patient will be sent to RegenMedTX, LLC, where renal cells will be expanded and SRC selected. SRC will be formulated in a gelatin based hydrogel at a concentration of 100 x 106 cells/mL, packaged in a 10 mL syringe, and shipped to the clinical site for use.
16050001|NCT02525250|Procedure|Realization of 3 Blood samples during study during treatment with lenalidomide|
16050002|NCT02525237|Drug|Apatinib|Apatinib (500 mg qd p.o.) until disease progression or intolerable toxicity
16050003|NCT02525237|Drug|S-1|S-1 (40 mg/m2 qd days 1-14 q3w p.o.) until disease progression or intolerable toxicity
16050004|NCT02525224|Dietary Supplement|Nutritional Supplement|2 Hard-shell liquid capsules taken twice daily with breakfast and dinner.
16050005|NCT02525211|Drug|Ropivacaine|a bolus of 10 ml of ropivacaine 7,5 mg / l then by a diffuser of local anesthesic (Ropivacaine 2mg / ml in continuous flow 10ml / hour) connected on the catheter the day after the intervention before returning at home
16050006|NCT02525211|Drug|physiological saline|a bolus of 10 ml of physiological saline in the catheter of multi- drilled cicatricial perfusion
16050007|NCT02525198|Dietary Supplement|fatty acid/flavonoid blend|see arm description
16050008|NCT02525198|Dietary Supplement|Placebo|see arm description
16050009|NCT02525185|Other|Diagnostic interventions; PET, MRI, cardiac ultrasound.|
16050010|NCT02525172|Drug|Rituximab|
16050011|NCT02525172|Drug|intravenous immune globulin|
16050012|NCT02525172|Drug|Bortezomib|
16050013|NCT02525172|Drug|Methotrexate|
16050014|NCT02525159|Dietary Supplement|DIM pills|Two pills of BioResponse DIM® 150 are equal to 75 mg of DIM pure
16050015|NCT02525159|Other|Placebo Pill|Placebo pills, proportionate by the same provider, vials and pills were the same size, shape and material containing the DIM pills
16050016|NCT02525146|Other|Modified ARTAS (Antiretroviral Treatment and Access to Services) intervention|
16050017|NCT02525133|Drug|XaraColl|Surgical implantation of 3 bupivacaine collagen implants
16050018|NCT02525133|Other|Placebo|Plain collagen implant (vehicle)
16050019|NCT02525120|Device|Triojection|Triojection is system intended to deliver a specific amount of ozone to a herniated disc.
16050020|NCT02525120|Procedure|Surgical discectomy|Patients will receive surgery to remove the herniated disc material.
16050021|NCT02525107|Dietary Supplement|Omega-3 capsules|SCD patients on Hydroxyurea
16050022|NCT02525107|Dietary Supplement|Placebo|SCD patients on Hydroxyurea
16050023|NCT02525107|Dietary Supplement|Omega-3 capsules|SCD patients not on Hydroxyurea
16050024|NCT02525107|Dietary Supplement|Placebo|SCD patients not on Hydroxyurea
16050025|NCT02525094|Biological|MEDI9929|Participants will receive 6 subcutaneous doses of MEDI9929 280 mg every 2 weeks for 12 weeks, with the last dose at Week 10.
16050026|NCT02525094|Biological|Placebo|Participants will receive 6 subcutaneous doses of placebo every 2 weeks for 12 weeks, with the last dose at Week 10.
16050027|NCT02525081|Drug|Ramipril (ACE-inhibitor)|up to 10 mg
16050028|NCT02525081|Drug|placebo|up to 10 mg
16050029|NCT02525068|Drug|AZD5363|Until confirmed disease progression.
16050030|NCT02525068|Drug|Enzalutamide|Until confirmed disease progression.
16050031|NCT02525055|Other|Infectious titre 1 (H3N2)|Infectious titre 1: 2.8 x 10*3 TCID50/mL
16050032|NCT02525055|Other|Infectious titre 2 (H3N2)|Infectious titre 2: 2.5 x 10*4 TCID50/mL
16050033|NCT02525055|Other|Infectious titre 3 (H3N2)|Infectious titre 3: 3.6 x 10*5 TCID50/mL
16050034|NCT02525055|Other|Infectious titre 4 (H3N2)|Infectious titre 4: 4.7 x 10*6 TCID50/mL
16050035|NCT02525055|Other|Infectious titre 5 (H3N2) (Subjects aged 18 to 45 years old)|Infectious titre 5: 3.5 x 10*5 TCID50/mL
16050036|NCT02525055|Other|Infectious titre 5 (H3N2) (Subjects aged 46 to 64 years old)|Infectious titre 5: 3.5 x 10*5 TCID50/mL
16050037|NCT02525029|Drug|Pregnyl®|"ARM 1: High-Risk aGVHD
~Standard of care immunosuppression, plus Pregnyl® at assigned dose subcutaneously every other day for up to 5 doses through day 7:
~If a complete or partial response, continue protocol treatment followed by hCG maintenance twice weekly for 10 doses beginning day 9 to 12.
~If no response, the patient will be taken off study treatment
~Doses for both arms:
~Phase I: up to 7 dose levels of Pregnyl® will be tested; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic.
~Phase II: the dose of Pregnyl will be that identified as the MTD during phase I."
16050114|NCT02524444|Drug|Mefloquine|Tabs Mefloquine 250mg
16050115|NCT02524444|Drug|Sulphadoxine-Pyrimethamine|Sulphadoxine 500mg , Pyrimethamine 25mg
16050362|NCT02522572|Drug|plerixafor|Plerixafor will be dosed subcutaneously and administered based on group assignment.
16050038|NCT02525029|Drug|Pregnyl®|"ARM 2a: Steroid Dependent aGVHD
~Standard of care immunosuppression, plus Pregnyl® at assigned dose subcutaneously every other day for up to 5 doses through day 7:
~If a complete or partial response, continue protocol treatment followed by hCG maintenance twice weekly for 10 doses beginning day 9 to 12.
~If no response, the patient will be taken off study treatment
~Doses for both arms:
~Phase I: up to 7 dose levels of Pregnyl® will be tested; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic.
~Phase II: the dose of Pregnyl will be that identified as the MTD during phase I."
16050039|NCT02525029|Drug|Pregnyl®|"ARM 2b: Steroid-Refractory aGVHD
~Standard of care immunosuppression, plus Pregnyl® at assigned dose subcutaneously every other day for up to 7 doses through day 14:
~If a complete or partial response, continue protocol treatment followed by hCG at the assigned dose maintenance twice weekly for 10 doses beginning day 15 to 17.
~If no response, the patient will be taken off study treatment
~Doses for both arms:
~Phase I: up to 7 dose levels of Pregnyl® will be tested; however dose levels -1 and -2 will be used only if dose level 1 proves too toxic.
~Phase II: the dose of Pregnyl will be that identified as the MTD during phase I."
16050040|NCT02525016|Biological|Blood sampling|
16050041|NCT02525016|Drug|Lidocaine|
16050042|NCT02525003|Dietary Supplement|Vitamin D2|Experimental group 2: daily vitamin D2 supplement 25ug/d for 8 weeks
16050043|NCT02525003|Dietary Supplement|Vitamin D3|Experimental group 3: daily vitamin D3 supplement 25ug/d for 8 weeks
16050044|NCT02525003|Other|Vitamin D2 fortified bread|Experimental group 4: vitamin D2 fortified bread containing 25 µg of vitamin D2/d (bread dose 87g/d) and placebo pill for 8 weeks
16050045|NCT02524990|Behavioral|Home-based follow-up with SQPT|Participants will be followed-up at home. They will receive an SQPT to perform at home two weeks after enrollment, and a scheduled follow-up phone call by study providers to determine the outcome of the procedure.
16050046|NCT02524977|Behavioral|Decision Support|Provision of recommended antithrombotic therapy based on atrial fibrillation decision support tool that uses both stroke and bleeding risk
16050047|NCT02524977|Behavioral|Educational Intervention Only|Educational conference series
16050048|NCT02524964|Drug|sodium tanshinone IIA sulfonate|eligible participants were randomized to receive sodium tanshinone IIA sulfonate injection (drip 80 mg/day for 7 days immediately after PCI)
16050049|NCT02524964|Other|control|equivalent volume of sodium chloride solution
16050050|NCT02524951|Drug|MSI-1436C|Dose escalation, single intravenous infusion twice a week for 3 weeks on a 4-week cycle.
16050051|NCT02524938|Dietary Supplement|Chlorogenic Acid (CGA) enriched coffee|"Chlorogenic Acid (CGA) enriched coffee Phase I: CGA-enriched coffee provided with a CGA content of 70-90 mg/100g. Daily CGA intake of 400mg.
~Phase II: recommendation for achieving a CGA-rich diet of at least 400mg/day (total polyphenol intake of at least 1g/day)"
16050052|NCT02524938|Dietary Supplement|Conventional coffee|Phase I: conventional coffee provided (low in CGA) Phase II: standard dietary advice
16050053|NCT02524925|Procedure|fast track protocol|Evaluation of postoperative stress
16050054|NCT02524899|Behavioral|Cognitive Remediation Therapy|Cognitive Remediation Therapy (CRT) will consist of fifteen 45-minute, twice weekly sessions over 7.5 weeks. During each session, subjects, seated at a desk in a private interview room in our research office suite, will work through exercises that are part of the Psychological Software Services CogReHab program. The software to be used is a multimedia, Windows-based program that consists of exercises aimed at improving areas of deficit within the schizophrenia spectrum, such as executive function, working memory, and social cognition.
16050055|NCT02524899|Drug|Guanfacine|After completing baseline cognitive testing, subjects will be randomized to guanfacine or placebo. Subjects in the active treatment arm will begin with a guanfacine dose of 0.5mg/day and be titrated up to a maximum of 2mg/day according to our well-tolerated protocol in schizophrenia subjects. The dosing schedule of active guanfacine will be as follows: 0.5mg/d for week 1, 1.0mg/d for week 2, 1.0 mg bid for weeks 3, 4, 5, 6, and 7 and 1.0mg/d for week 8.
16050056|NCT02524899|Drug|Placebo|After completing baseline cognitive testing, subjects will be randomized to guanfacine or placebo. Subjects in placebo arm will have matching schedule as active arm.
16050057|NCT02524886|Device|GPi DBS with Medtronic electorde and Activa PC pulsegenerator|The electric stimulation of 2 leads implanted in the Globus Pallidus internus
16050058|NCT02524873|Device|Geneticure Collection Kit for Pharmaocogenetics of Hypertension|Buccal (cheek) swab kit for DNA collection for analysis of genes for hypertension
16050059|NCT02524860|Device|Focal-Fusion Bx|The Focal-Fusion Bx device uses hardware and software to overlay targets onto the live ultrasound image in real-time. This allows the urologist to take biopsy samples from tissue that looked suspicious on the patient's MRI.
16050060|NCT02524847|Drug|Methoxsalen|Sterile solution used in conjunction with photopheresis procedure.
16050061|NCT02524847|Procedure|Extracorporeal Photopheresis (ECP)|
16050062|NCT02524834|Procedure|Exclusion of thoracoabdominal lesion|Endovascular repair of thoracoabdominal lesion with a physician modified Medtronic Valiant stent graft
16050063|NCT02524834|Device|Endovascular Device Implant|Endovascular repair of thoracoabdominal lesion with a physician modified Medtronic Valiant stent graft
16050064|NCT02524821|Device|Gelesis100|3 capsules each containing 0.75 mg
16050065|NCT02524821|Drug|Metformin|1 tablet of 850 mg
16050066|NCT02524795|Dietary Supplement|Hiomega-3 supplement of Naturalis® company -|Patients (N=22) were seen at baseline (T0) and at week 12 (T1) for clinical, laboratory and nutritional assessment, and were contacted by telephone in week 6 to check on compliance and any adverse events. Patients received, throughout 12 weeks, two tablets per day of omega-3 fatty acids (540mg of EPA and DHA of 100mg; Hiomega-3 supplement of Naturalis® company - registered in the National Health Department number 4.1480.0006.001-4). All participants were instructed not to take omega-3 rich foods during the study period.
16050067|NCT02524782|Biological|MEDI-4166|MEDI-4166 administered subcutaneously
16050068|NCT02524782|Biological|Placebo|Placebo administered subcutaneously
16050069|NCT02524769|Drug|conjugated estrogen|0.625 mg conjugated estrogen/gram and instructions to use 0.5 grams twice weekly with the applicator.
16050070|NCT02524756|Procedure|laparoscopic nerve-sparing radical hysterectomy-type III/C1|
16050071|NCT02524756|Procedure|laparoscopic radical hysterectomy (type III/C2).|
16050232|NCT02523547|Drug|Baraclude|0.5mg/day
16050473|NCT02521818|Other|Modified Atkins Diet|
16050072|NCT02524743|Drug|acetaminophen|The venous drainage was occluded for 120 seconds by using a rubber tourniquet on the upper arm and the patients were pretreated acetaminophen (50mg and 25 mg IV) before the injection of rocuronium.Twenty seconds after the administration of rocuronium, 5 mg/kg of thiopental was administered IV. After orotracheal intubation, anesthesia was continued with sevofluorane during 40 % oxygen and 60 % air. Twenty-four hours after the operation, the injection site was checked for any complications, such as pain (absent/ present), swelling or allergic reaction by an anesthesiologist who did not know which drug was administered.
16050073|NCT02524743|Drug|Lidocaine|The venous drainage was occluded for 120 seconds by using a rubber tourniquet on the upper arm and the patients were pretreated lidocaine (20 mg and 40 mg IV) before the injection of rocuronium.Twenty seconds after the administration of rocuronium, 5 mg/kg of thiopental was administered IV. After orotracheal intubation, anesthesia was continued with sevofluorane during 40 % oxygen and 60 % air. Twenty-four hours after the operation, the injection site was checked for any complications, such as pain (absent/ present), swelling or allergic reaction by an anesthesiologist who did not know which drug was administered.
16050074|NCT02524743|Other|Placebo|The venous drainage was occluded for 120 seconds by using a rubber tourniquet on the upper arm and the patients were pretreated 5 ml iv normal saline before the injection of rocuronium.Twenty seconds after the administration of rocuronium, 5 mg/kg of thiopental was administered IV. After orotracheal intubation, anesthesia was continued with sevofluorane during 40 % oxygen and 60 % air. Twenty-four hours after the operation, the injection site was checked for any complications, such as pain (absent/ present), swelling or allergic reaction by an anesthesiologist who did not know which drug was administered.
16050075|NCT02524730|Device|Primary total knee replacement (Scorpio NRG CR Total Knee System)|Scorpio NRG CR Total Knee System
16050076|NCT02524717|Drug|JNJ-56021927|Participants will receive JNJ-56021927 240 milligram (mg) orally once on Day 1.
16050077|NCT02524704|Device|CT scan|Applied only when part of the patient's standard care
16050078|NCT02524691|Device|Use of Rapid Immunoassay Tests for the Detection of PROM|Patient will undergo both rapid immunoassay tests for the detection of PROM and the standard of care for the diagnosis of PROM using a sterile speculum (SSE). Women who cannot be confirmed clinically by the SSE will undergo an ultrasound evaluation to determine the amniotic fluid index. The patient will be treated according to the results of the SSE and ultrasound, not the results of rapid immunoassay tests. The provider conducting the SSE will be blinded to the results of the rapid immunoassay tests.
16050079|NCT02524678|Drug|Placebo|
16050080|NCT02524678|Drug|URC102|
16050081|NCT02524665|Other|MAXCLARITY II (2.5% BPO) Foam Cleanser|Available over the counter.
16050082|NCT02524665|Other|MAXCLARITY II (2.5% BPO) Foam Treatment|Available over the counter.
16050083|NCT02524665|Other|MAXCLARITY II (0.5% Salicylic Acid) Toner Foam|Available over the counter.
16050084|NCT02524665|Other|MURAD Clarifying Cleanser (1.5% SA)|Available over the counter.
16050085|NCT02524665|Other|Exfoliating Acne Treatment Gel (1% SA)|Available over the counter.
16050086|NCT02524665|Other|Skin Perfecting Lotion|Available over the counter.
16050087|NCT02524652|Drug|Ropivacaine 0.5% 20 mLs|Injection of the local anesthetic at the end of surgery, either in the surgical sites by the surgeon, or in the adductor canal block by the anesthesiologist under ultrasound guidance.
16050088|NCT02524639|Drug|Sirolimus|Subjects will receive 1 mg/m2/day orally for 6 weeks. Maintenance dose will be titrated up or down by 0.25-0.5 mg/m2/day every 4 days. Serum concentration will be checked on day 4 after initial therapy and 4 days after any dose adjustment. Levels will be checked at lease once a week during the duration of the study. Target serum concentration range is 5-10 ng/mL.
16050089|NCT02524626|Procedure|Sham stimulation|
16050090|NCT02524626|Procedure|Vagus stimulation|
16050091|NCT02524613|Other|Pelvis CT scan|
16050092|NCT02524600|Device|myocardial IQ-SPECT imaging applied to scintigraphic imaging|
16050093|NCT02524600|Device|scintigraphic imaging|
16050094|NCT02524587|Device|standard polyethylene acetabular irradiated at 3 Mrad|
16050095|NCT02524587|Other|radio stereometric analysis (RSA) of the acetabular|
16050096|NCT02524587|Device|acetabular polyethylene vitamys®|
16050097|NCT02524574|Procedure|cardiac Rehabilitation|
16050098|NCT02524574|Other|Tomography Positron Emission|
16050099|NCT02524561|Drug|CEE pill|Conjugated equine estrogens 0.45 mg/day
16050100|NCT02524561|Drug|Estradiol patch|Climara 50 mcg/day
16050101|NCT02524561|Drug|Active Progesterone|Prometrium (micronized progesterone USP encapsulated with peanut oil) 200 mg daily for the first 12 days of each month at bedtime
16050102|NCT02524561|Other|Placebo tablet|Placebo tablet
16050103|NCT02524561|Other|Placebo patch|placebo patch
16050104|NCT02524561|Other|Placebo progesterone|placebo progesterone
16050105|NCT02524548|Other|SMS reminder|Weekly SMS reminder to take aromatase inhibitors as prescribed by doctor for 1 year
16050106|NCT02524535|Other|Therapeutic alliance|
16050107|NCT02524522|Device|INTELLiVENT-ASV mode|Discontinuation with INTELLiVENT-ASV mode: discontinuation from mechanical ventilation in the early postoperative period will be provided by quick-wean option of INTELLiVENT-ASV mode
16050108|NCT02524522|Device|SIMV mode|Discontinuation with SIMV mode: discontinuation with SIMV mode: discontinuation from mechanical ventilation in the early postoperative period will be provided in SIMV mode using physician driven algorithm
16050109|NCT02524483|Behavioral|Therapeutic Challenge Program|The Therapeutic Challenge Program will consist of a 5 minute warm-up, 20 minutes of challenging balance training, and 20 minutes of challenging treadmill and overground walking.
16050110|NCT02524483|Behavioral|Therapeutic Exercise Program|The Therapeutic Exercise Program will consist of 15 minutes of strength training and flexibility exercises, 15 minutes of balance exercises, and 15 minutes of treadmill walking.
16050111|NCT02524470|Device|VSP System - NEHB Configuration|VSP System - NEHB Configuration will take and record participant vital signs. NEHB is the last name of the physician who developed the configuration. It is not an acronym.
16050112|NCT02524470|Device|VSP System - PAL Configuration|VSP System - PAL Configuration will take and record patient vital signs. PAL is the name created by the engineering team of this device. It is not an acronym.
16050113|NCT02524457|Other|This is an observational study. There are no interventions|
16050116|NCT02524431|Other|Collection of trabecular meshwork tissue during surgery|Tissue is collected during surgery at Wills Eye and then processed at thomas jefferson to identify the trabecular meshwork using light microscope. The ocular tissue will be fixed and the mitochondrial cross sections at the longest extent will be measured under electron microscopy (EM) in order to identify the mitochondrial dynamics. Quantitative Polymerase Chain Reaction (qPCR) will be done to identify proteins responsible for mitochondrial fusion.
16050117|NCT02524418|Procedure|Cholangiopancreatoscopy|An ERCP with cholangioscopy/pancreatoscopy will be performed using the Spyglass DS. Clinical outcomes will be collected and analyzed.
16050118|NCT02524405|Other|Pittsburgh Compound B [11C]-PIB|This is a cross-sectional study of patients with various forms of cognitive impairment and a healthy control group for comparison. Brain amyloid PET scans using the radioligand Pittsburgh Compound B [11C]-PIB, which is not yet approved for clinical use in Canada, will be performed in all subjects.
16050119|NCT02524392|Other|Independent medical evaluation|The independent medical evaluation (IME) will be performed by specialists in general medicine, temporarily hired by the county welfare service. The independent medical evaluation (IME) procedure is developed by the Research Unit for General Practice at Uni Research Health in Norway.
16050120|NCT02524379|Drug|Glyburide|3 day drug regimen beginning 8 hours after acute traumatic spinal cord injury.
16050121|NCT02524366|Device|Artificial Urinary Sphincter|
16050122|NCT02524353|Other|cardiac surgery|Surgical cardiac procedures despite benefiting the clinical condition of the patient with potential increased survival and reduced risk of death can cause both immediate and long-term functional changes that may influence the appropriate re-inclusion of this individual the daily life practices as well as labor and social activities. Such changes resulting from surgical procedures in the short term are already well documented but the occurrence of these same changes in the late period and its influence on patient's daily lives are not well documented.
16050123|NCT02524327|Other|Toolbox: Automated group|A dedicated algorithm controls the infusion rate of drugs depending on the magnitude of variation of the bispectral index
16050124|NCT02524327|Other|Manual group|The anesthesiologist controls the infusion rate of drugs depending of the magnitude of variation of the bispectral index
16050125|NCT02524301|Drug|Positron Emission Tomography using [11C]diprenorphine|PET using [11C]diprenorphine
16050126|NCT02524288|Drug|ENG-E2 125 μg/300 μg vaginal ring|Up to 13 cycles of ENG-E2 125 μg/300 μg administered intravaginally, each cycle consisting of 21 days of vaginal ring use followed by 7 vaginal ring-free days.
16050127|NCT02524275|Drug|Capecitabine|Given PO
16050128|NCT02524275|Drug|Docetaxel|Given IV
16050129|NCT02524275|Other|Quality-of-Life Assessment|Ancillary studies
16050130|NCT02524275|Other|Questionnaire Administration|Ancillary studies
16050131|NCT02524262|Dietary Supplement|Slow-release L-cysteine|Bind and inactivate acetaldehyde formed from ethanol by covalent binding to L-cysteine
16050132|NCT02524249|Drug|Caffeine|
16050133|NCT02524249|Drug|Placebo (dextrose)|
16050134|NCT02524236|Drug|Botox injection in the prostate|transrectal access of prostatic injection
16050135|NCT02524223|Other|Systematic HPV DNA assay in semen and cervicovaginal scrape|Screening of HPV status at the genital level of males enrolled in MAP program.
16050136|NCT02524223|Other|Systematic HPV DNA cervicovaginal scrape|Screening of HPV status at the genital level of females enrolled in MAP program.
16050137|NCT02524223|Other|systematic HPV Status in newborns in case of pregnancy|
16050138|NCT02524210|Drug|Dabigatran|dabigatran etexilate 150 mg/day (1 day)
16050139|NCT02524210|Drug|Rabeprazole and Dabigatran|rabeprazole 20 mg / day for 5 days, then the 6th day concomitant rabeprazole 20 mg of dabigatran etexilate 150 mg;
16050140|NCT02524210|Drug|Omeprazole and Dabigatran|omeprazole 20 mg / day for 5 days, then the sixth day concomitant omeprazole 20 mg and 150 mg dabigatran etexilate
16050141|NCT02524197|Drug|CR845 0.25 mg|Subjects will dose orally twice a day with CR845 0.25 mg tablets for two weeks. A diary will be kept for recording the individual's pain scores and dosing accountability.
16050142|NCT02524197|Drug|CR845 0.50 mg|Subjects will dose orally twice a day with CR845 0.50 mg tablets for two weeks. A diary will be kept for recording the individual's pain scores and dosing accountability.
16050143|NCT02524197|Drug|CR845 1 mg|Subjects will dose orally twice a day with CR845 1 mg tablets for two weeks. A diary will be kept for recording the individual's pain scores and dosing accountability.
16050144|NCT02524197|Drug|CR845 5 mg|Subjects will dose orally twice a day with CR845 5 mg tablets for two weeks. A diary will be kept for recording the individual's pain scores and dosing accountability.
16050145|NCT02524184|Drug|sildenafil|sildenafil 100 mg per day for 7 days.
16050146|NCT02524184|Drug|placebo|an identical placebo per day for 7 days
16050147|NCT02524171|Behavioral|Moral Reconation Therapy (MRT)|MRT is a group-based cognitive-behavioral intervention to restructure antisocial thinking. Patients will receive two groups per week of this intervention for approximately 12 weeks, in addition to the usual care they receive in the mental health residential rehabilitation treatment program.
16050148|NCT02524158|Behavioral|Yoga Therapy for CLBP|Classes begin with a few minutes of simple seated breathing exercises. Depending on their mobility, participants can sit either on the floor or on a chair. This is followed by gentle warm-up stretches. Participants are then led through a series of standing postures, seated postures and floor postures. The difficulty of the poses will gradually increase over the duration of the 12 weeks, and appropriate modifications are offered to participants whenever needed. Deep and rhythmic breathing will be emphasized throughout. Each class will end with a supine resting pose.
16050149|NCT02524145|Other|Static Handgrip|Subjects will perform static handgrip at 40% of maximum voluntary contraction until fatigue.
16050150|NCT02524145|Drug|Dexmedetomidine|Subjects will be given dexmedetomidine to suppress sympathetic outflow to minimize sympathetic control over resting heart rate. Subjects will then be given glycopyrrolate to suppress parasympathetic tone to minimize parasympathetic control over resting heart rate. After achievement of autonomic blockade, cardiac beta receptor sensitivity will be assessed by graded infusions of isoproterenol until heart rate increases 30 beats above baseline.
16050233|NCT02523534|Procedure|MRI|MRI images will be taken in conjunction with the clinically indicated cardiac MRI.
16050234|NCT02523534|Procedure|ECG|ECG readings will be taken prior to the participants clinically indicated procedure.
16050151|NCT02524145|Drug|Glycopyrrolate|Subjects will be given dexmedetomidine to suppress sympathetic outflow to minimize sympathetic control over resting heart rate. Subjects will then be given glycopyrrolate to suppress parasympathetic tone to minimize parasympathetic control over resting heart rate. After achievement of autonomic blockade, cardiac beta receptor sensitivity will be assessed by graded infusions of isoproterenol until heart rate increases 30 beats above baseline.
16050152|NCT02524145|Drug|Isoproterenol|Subjects will be given dexmedetomidine to suppress sympathetic outflow to minimize sympathetic control over resting heart rate. Subjects will then be given glycopyrrolate to suppress parasympathetic tone to minimize parasympathetic control over resting heart rate. After achievement of autonomic blockade, cardiac beta receptor sensitivity will be assessed by graded infusions of isoproterenol until heart rate increases 30 beats above baseline.
16050153|NCT02524132|Behavioral|Physical Activity|
16050154|NCT02524119|Drug|LEE011|600 mg PO once daily will be given orally on days 1-21 of a 28 day cycle (3 weeks on / 1 week off) :until disease progression, unacceptable toxicity, death, or discontinuation from the study treatment due to any other reason
16050155|NCT02524119|Procedure|Chemoembolization|Patients will be treated with chemoembolization once every 4 weeks with up to 4 total chemoembolizations within the first 6 months from the initial chemoembolization.
16050156|NCT02524106|Drug|Bococizumab|PF-04950615 is a humanized monoclonal antibody against the proprotein convertase subtilisin kexin type 9 (PCSK9) enzyme responsible for the degradation of the low-density lipoprotein receptor (LDLR), being developed by Pfizer, Inc for the treatment of primary hyperlipidemia and mixed dyslipidemia.
16050157|NCT02524106|Drug|Placebo|placebo
16050158|NCT02524093|Behavioral|Positive Mental Training|Positive Mental Training consists of twelve eighteen minute audio tracks. Each is listened to in turn every day, once a day for a week (or at least 5 days in a week). This means that to use the treatment properly you need to spend 18 minutes a day for 12 weeks listening to it. Each track guides the listener through different instructions which aim to build skills and bring about positive change. The programme begins with simple relaxation, going on to support the creation of pictures in your head of safe places and a more positive future.
16050159|NCT02524093|Other|treatment as usual|
16050160|NCT02524080|Procedure|Triage to optimal healthcare level|Triage to optimal healthcare level
16050161|NCT02524067|Behavioral|Multifactorial circadian concept|Circadian light, systematic information, music, individual foreclosure
16050162|NCT02524054|Drug|Furosemide|80 mg of Furosemide in 8ml saline will be aerosolized using ultrasonic screen nebulizers. Aerosol will be delivered using a clinical volume-control ventilator to regulate inspiratory flow and volume.
16050163|NCT02524054|Drug|Aerosolized saline|8ml saline will be aerosolized using ultrasonic screen nebulizers. Aerosol will be delivered using a clinical volume-control ventilator to regulate inspiratory flow and volume.
16050164|NCT02524041|Device|HR-pQCT|The Xtrem CT scanco device is a HR-pQCT used for 3D bone measurements at the tibia and the radius levels in humans
16050165|NCT02524041|Other|blood specimen|blood specimen
16050166|NCT02524015|Other|Novel physical therapy|
16050167|NCT02524015|Other|Standard physical therapy|
16050168|NCT02524002|Dietary Supplement|Accel Gel|Accel Gel by PacificHealth Labs in Matawan, NJ.
16050169|NCT02524002|Dietary Supplement|Usual clear diet|Usual clear liquids
16050170|NCT02523989|Other|study group|Explore the relationship of heavy metals and health related quality of life, including the relationship between the developmental delays and polymorphism of arsenic methylation enzymes, arsenic methylation capability and blood metals. Identify the interaction of children function, health condition, and quality of life and arsenic methylation and blood metals in children with developmental delays.
16050171|NCT02523976|Drug|Dasatinib|Second-generation tyrosine kinase inhibitor
16050172|NCT02523976|Drug|prednisone|
16050173|NCT02523976|Drug|cyclophosphamide|
16050174|NCT02523976|Drug|daunorubicin|
16050175|NCT02523976|Drug|vincristine|
16050176|NCT02523976|Drug|cytarabine|
16050177|NCT02523976|Drug|mercaptopurine|
16050178|NCT02523976|Drug|methotrexate|
16050179|NCT02523976|Drug|dexamethasone|
16050180|NCT02523976|Drug|mitoxantrone|
16050181|NCT02523976|Drug|etoposide|
16050182|NCT02523976|Procedure|allogeneic hematopoietic stem cell transplantation|
16050183|NCT02523976|Procedure|autologous hematopoietic stem cell transplantation|
16050184|NCT02523963|Other|family work shop|"The family work shop has 5 courses, with 6 families in one course.
~One course of intervention: 2-3 hours per session, one time per week, for a total of 6 sessions in 6 week periods"
16050185|NCT02523950|Procedure|Staged phacoemulsification and DMEK|"Stage 1. Phacoemulsification is performed individually. During phacoemulsification, viscoelastic materials and anterior lens capsule are used to protect corneal endothelial cells.
~Stage 2. DMEK is performed secondarily according to the corneal status of patients."
16050186|NCT02523950|Procedure|Combined phacoemulsification and DMEK|Routine phacoemulsification and DMEK are performed simultaneously.
16050187|NCT02523950|Device|Intraocular lens (IOL) implantation|After phacoemulsification and removal of all the lens material, a one-piece IOL is implanted into the lens capsule.
16050188|NCT02523937|Other|Soluble Fibrin|Evaluating the diagnostic performances of the assay in terms of sensitivity, specificity, negative and positive predictive values; from calculation of the area under the curve in comparison with the D-dimers.
16050189|NCT02523924|Drug|18F-DCFPyL|18F-DCFPyL PET/CT
16050190|NCT02523911|Drug|Simethicone|Patients will be randomized to receive either simethicone or placebo in addition to oral sodium sulfate/potassium sulfate/magnesium sulfate solution (Suprep), and will be blinded to whether they are in the simethicone arm or the placebo arm of the trial. Simethicone and placebo will be prepared as identically-appearing liquid solution (2.4 mL) with the assistance of a pharmacist. The simethicone or placebo solution will then be assigned to patients according to the randomization scheme and samples will be labeled with patient information prior to distribution. Only the pharmacist will participate in the labeling process and know which patients receive simethicone or placebo; administering staff, nurses, physicians, and patients will be blinded to this.
16050235|NCT02523521|Behavioral|Physical activity program|physical activity program for a bronchopulmonary dysplasia children.
16050474|NCT02521818|Other|NIA Diet for Seniors|
16050191|NCT02523911|Drug|Placebo|Patients will be randomized to receive either simethicone or placebo in addition to oral sodium sulfate/potassium sulfate/magnesium sulfate solution (Suprep), and will be blinded to whether they are in the simethicone arm or the placebo arm of the trial. Simethicone and placebo will be prepared as identically-appearing liquid solution (2.4 mL) with the assistance of a pharmacist. The simethicone or placebo solution will then be assigned to patients according to the randomization scheme and samples will be labeled with patient information prior to distribution. Only the pharmacist will participate in the labeling process and know which patients receive simethicone or placebo; administering staff, nurses, physicians, and patients will be blinded to this.
16050192|NCT02523911|Drug|sodium sulfate/potassium sulfate/magnesium sulfate solution|Both arms will receive sodium sulfate/potassium sulfate/magnesium sulfate solution for bowel preparation
16050193|NCT02523898|Drug|metformine|1500 mg metformine 8week plus 100 mg clomiphene for 5 days
16050194|NCT02523898|Drug|placebo|placebo 8 weeks plus 100 mg clomiphene for 5 days
16050195|NCT02523898|Drug|clomiphene citrate|100 mg clomiphene for 5 days starting from day 3 of their spontaneous menses or withdrawal bleeding induced by progestin administration
16050196|NCT02523859|Drug|Propofol|Hypnotic drug used for anesthesia
16050197|NCT02523859|Drug|Remimazolam|Benzodiazepine being developed for sedation and anesthesia.
16050198|NCT02523846|Drug|morphine|"Investigators use the formula that was published by Pamela Macintyre in her paper entitled Age is the Best Predictor of Postoperative Morphine Requirements. The estimation for the first 24-hour morphine requirement after surgery is calculated as: 100 - age (year).
~So, half of the total 24-hour morphine requirement will be infused over 24 hours.
~e.g. background morphine infusion= (100-Age)/ 2/ 24 (mg/hour)"
16050199|NCT02523846|Behavioral|Patient re-education|A similar leaflet will be used to re-educate patient at 4 hour after surgery. The correct method to initiate IV-PCA dose, possible side effects and addiction issue will be explained again and re-emphasized
16050200|NCT02523833|Drug|Salbutamol|Salbutamol after spirometry, plethysmography and forced oscillation technique.
16050201|NCT02523820|Drug|fluticasone propionate|Flixotide 1 mg + NSS upto 4 ml nebulized after extubation. Record vital signs and modified Westley score at 0, 15, 30, 60 min and 2,4,6 hours
16050202|NCT02523820|Drug|Placebo|NSS 4 ml nebulized after extubation. Record vital signs and modified Westley score at 0, 15, 30, 60 min and 2,4,6 hours
16050203|NCT02523794|Other|Electro-kinetically Modified Water|Subjects assigned to this arm will receive the EMW
16050204|NCT02523794|Other|Placebo|Purified Drinking Water
16050205|NCT02523781|Other|information pamphlet|The intervention group receives the information pamphlet
16050206|NCT02523768|Drug|ATG-F|
16050207|NCT02523768|Drug|Simulect|
16050208|NCT02523755|Drug|Epidural analgesia Ropivacaine|Measurement of regional distribution as assessed by EIT before and after injection of local anesthetics
16050209|NCT02523755|Drug|Absence of epidural analgesia|Measurement of regional distribution as assessed by EIT before and after delivery
16050210|NCT02523742|Device|IMRf|
16050211|NCT02523742|Other|language task and a reference task (rest and Tamil)|
16050212|NCT02523729|Dietary Supplement|Anke Malz|non-alcoholic malt drink
16050213|NCT02523716|Other|Hypoxia|Participants live within an altitude residence facility. Hypoxic acclimatisation will be achieved by venting the rooms with air containing a reduced oxygen content. The degree of hypoxia is ramped over a 2-day period as participants experience 14 hours of overnight hypoxic exposure (simulating altitude of : 1830m on Day 1; 2130m on Day 2). The final 5 days will be spent entirely in the altitude residence facility at a consistent hypoxia level (simulating approximately 2440m).
16050214|NCT02523716|Other|Normoxia|Participants will live in the altitude residence facility. As a sham-control, normal sea level air will be circulated throughout the house.
16050215|NCT02523703|Biological|glutamate and aspartate|
16050216|NCT02523690|Drug|Lorcaserin|10 mg, oral or enteral, single dose. 30 mg, oral or enteral, single dose two days later
16050217|NCT02523690|Drug|Placebo|Oral or enteral, single dose. Oral or enteral, single dose two days later
16050218|NCT02523664|Drug|Hydrocortisone|effects of hydrocortisone on memory while fMRI
16050219|NCT02523664|Drug|Placebo|
16050220|NCT02523651|Genetic|DPSC injection|A 0.5ml saline preparation containing 1000000 DPSCs were injected at the local periodontal defects immediately after periodontal scaling and root planing.
16050221|NCT02523651|Other|Placebo|A 0.5ml saline preparation were injected at the local periodontal defects immediately after periodontal scaling and root planing.
16050222|NCT02523638|Drug|Pegylated-Proline-Interferon alpha-2b in a Pre-filled Pen|Subjects will continue to receive the dosage which delivers the optimal disease response (hematocrit [Hct]<45%, platelets [PLTs]<400 x 109/L and leukocytes [WBCs]<10 x 109/L), as determined in the PROUD-PV study, preferably at the level of target blood values.
16050223|NCT02523625|Device|Ultrasound of temporal and axillary arteries|Each patient will have a clinical assessment and ultrasound examination of both temporal and axillary arteries
16050224|NCT02523612|Procedure|Biopsy|
16050225|NCT02523612|Procedure|Blood sample|
16050226|NCT02523599|Drug|XaraColl|Surgical implantation of 3 bupivacaine collagen implants
16050227|NCT02523599|Other|Placebo|Plain collagen implant (vehicle)
16050228|NCT02523586|Other|Oxygen administration|Subjects will breathe room air for 90 seconds. FiO2 will be measured for 30 seconds. Testing of masks will be performed with oxygen set at high flow through simple mask, non-rebreather mask, OxyMaskTM, and anesthesia mask with headstrap and Jackson-Rees circuit. After placement of each mask and starting oxygen, subjects will breathe normally for 90 seconds. FiO2 will be measured for 30 seconds. After each trial, subjects will take one vital capacity breath. Between testing each mask, subjects will breathe room air for 5 minutes to confirm stability of hemodynamic status. Respiratory rate and FiO2 data will be recorded during each breath to determine oxygen percentages. At the end of the 30 second sampling period, a final measurement will be taken during a forced vital capacity breath.
16050229|NCT02523573|Procedure|Adult ARF ICU patients needing BAL with HFNC|bronchoalveolar lavage is performed in spontaneously breathing patients under high flow nasal cannula oxygen
16050230|NCT02523560|Other|home-based telerehabilitation|Patients qualified to the study group will undergo, at five medical units a 9-week program of early hybrid, comprehensive cardiac telerehabilitation.
16050231|NCT02523547|Drug|Cavir|0.5mg/day
16050236|NCT02523508|Behavioral|Experimental group|Subject will be put into lying position, small amplitude of passive movement on the lumbar spine of the subject. The procedure will last for 1 minute.
16050237|NCT02523508|Other|Control group|Passive limb mobilization which did not involve the spine
16050238|NCT02523469|Biological|ALT-803|
16050239|NCT02523469|Biological|Nivolumab|
16050240|NCT02523456|Behavioral|Training|The staff will be trained on early detection and management of clinically deteriorating patients based on the EWS selected.
16050241|NCT02523456|Behavioral|Introduce EWS|An EWS that is appropriate for use in the study setting will be selected during the second components of the study. This EWS will then be adapted for this component.
16050242|NCT02523443|Other|IV PCA|Patients undergoing IV PCA for pain control will have intravenous (IV) analgesia provided through a demand pump started in the recovery room.
16050243|NCT02523443|Other|PCEA|Patients in this group will have the epidural catheter placed by the anesthesia pain service team in the pre-surgical center (PSC) as performed routinely at MSKCC. The epidural will be used intra-operatively at the end of liver resection phase of the surgical procedure, once the specimen has been extracted, and continued subsequently in the post-operative phase for pain management.
16050244|NCT02523430|Procedure|interventional therapy|nasopharyngeal carcinoma patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）
16050245|NCT02523417|Procedure|interventional therapy|breast cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）
16050246|NCT02523404|Procedure|interventional therapy|lung cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）
16050247|NCT02523391|Drug|TA-8995|Capsule
16050248|NCT02523391|Drug|TA-8995|Tablet
16050249|NCT02523378|Behavioral|Edmonton Symptom Assessment Scale|Participants complete the symptom survey alone, or with the help of a research nurse or assistant.
16050250|NCT02523378|Behavioral|Interview|After completion of the symptom questionnaire, participants asked if they preferred completing the questionnaire alone, or if they preferred to have a nurse help them answer the questions.
16050251|NCT02523365|Procedure|interventional therapy|cervical carcinoma patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）
16050252|NCT02523352|Procedure|Non-Invasive Ventilation|Progressive increase in airway pressure to open lungs atelectatic regions.
16050253|NCT02523352|Procedure|Esophageal catheter positioning|The esophageal tube (8 French diameter catheter) will be positioned in the larger nostril previous topical anesthesia
16050254|NCT02523326|Device|saliva samples obtained with mouthwash|saliva samples obtained with mouthwash
16050255|NCT02523313|Drug|Nivolumab + Placebo|Nivolumab will be applied at a dose of 3 mg/kg given as IV infusion every 2 weeks for up to 1 year after initial dosing or until PD + Placebo instead of Ipilimumab on weeks 1, 4, 7 and 10 + Placebo instead of Nivolumab on weeks 4 and 10.
16050256|NCT02523313|Drug|Nivolumab + Ipilimumab|Nivolumab (1 mg/kg) and Ipilimumab (3 mg/kg) will be applied as IV infusion every 3 weeks for 4 doses. Both study drugs are to be administered on the same day over the first 12 weeks + Nivolumab-Placebo on weeks 3, 5, 9 and 11. After week 12 Nivolumab is given as maintenance and will be applied at a dose of 3 mg/kg IV every 2 weeks for up to 1 year after initial dosing (of the combination) or until PD.
16050257|NCT02523313|Drug|Double Placebo Control|Placebo instead of Nivolumab and Placebo instead of Ipilimumab will be applied as IV infusion every 3 weeks for 4 doses. Both placebos are to be administered on the same day over the first 12 weeks + Placebo instead of Nivolumab on weeks 3, 5, 9 and 11. After week 12 Placebo instead of Nivolumab is given as maintenance and will be applied intravenously every 2 weeks for up to 1 year after initial dosing (of the combination) or until PD.
16050258|NCT02523300|Procedure|TEVAR|The patients will be undertaken TEVAR
16050259|NCT02523300|Drug|Glucocorticoids|About 120 patients will be given glucocorticoids within 2h after TEVAR as experimental group
16050260|NCT02523300|Drug|saline|The other 120 patients will be given saline as control group
16050261|NCT02523287|Biological|Fluad|Randomized assignment
16050262|NCT02523287|Biological|Saline|Randomized assignment
16050263|NCT02523274|Drug|Resveratrol|Dietary compound commonly found in grapes and red wine. Will be given in 250 mg/day and 1000 mg/day dosages
16050264|NCT02523274|Drug|Placebo|Vegetable-based cellulose
16050265|NCT02523274|Behavioral|Exercise|Multi-modal exercise regimen, 3 days/week
16050266|NCT02523261|Procedure|direct aspiration procedure|Revascularization by endovascular thrombectomy using the distal aspiration first pass technique
16050267|NCT02523261|Procedure|stent retriever procedure|Revascularization by endovascular thrombectomy using a mechanical thrombectomy device
16050268|NCT02523248|Procedure|tonsillectomy|Tonsillectomy with cold steel
16050269|NCT02523248|Procedure|Uvulopalatopharyngoplasty|Tonsillectomy and uvulopalatoplasty with cold steel and single sutures of the palate and tonsillar pillars including palatopharyngeal muscle
16050270|NCT02523235|Drug|ropivacaine 0.2%|Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 minute lockout
16050271|NCT02523222|Dietary Supplement|40% Dextrose gel|40% dextrose gel will be rubbed into the hypoglycemic infant's buccal mucosa at a dose of 0.5ml/kg.
16050272|NCT02523209|Device|HR-pQCT|HR-pQCT (High Resolution peripheral micro Computerized Tomography) is a device used for 3D bone measurements at the tibia and the radius levels in humans.
16050273|NCT02523209|Device|DEXA|The Lunar DEXA (Dual Energy X-ray Absorptiometry) is a third generation multi-captor DEXA (Dual Energy X-ray Absorptiometry) device that allows short duration measurements ( <15 min). It measures Bone Mineral Density at the spine (L1-L4) and the femoral neck
16050274|NCT02523196|Drug|HepQuant-SHUNT (Drug and Device) #65,123 (4D-cholate) and IND #65,121 (13C-cholate)|The HQ-SHUNT test is being evaluated for safety and effectiveness as an alternative to Hepatic Venous Pressure Gradient (HVPG) testing in patients with liver disease
16050275|NCT02523196|Device|Hepatic Venous Pressure Gradient (HVPG)|Hepatic Venous Pressure Gradient (HVPG) is a test for patients with liver disease
16050276|NCT02523183|Drug|Medical Cannabis|Pediatric patients with medically refractory epilepsy and treated with medicinal cannabis.
16050277|NCT02523170|Device|AQ-Flex 19 probe (Mauna Kea Technologies, Paris)|Needle-based Confocal Laser Endomicroscopy (nCLE)
16050278|NCT02523157|Other|Wellbeing Plan|The Wellbeing Plan is a short self-help leaflet designed to improve emotional wellbeing of women during and after pregnancy by providing information, raising awareness, helping a woman identify her own symptoms, provide coping strategies, and identify key people who can support the woman during this time.
16050279|NCT02523157|Other|Control task|Information about physical health in pregnancy, matched for readability (Flesch score) and length/duration with the Wellbeing Plan
16050280|NCT02523144|Drug|Chloral Hydrate|70mg/kg chloral hydrate
16050281|NCT02523144|Drug|Dexmedetomidine|2mcg/kg
16050282|NCT02523144|Drug|Dexmedetomidine|3mcg/kg
16050283|NCT02523144|Drug|Placebo|Flavored placebo syrup
16050284|NCT02523131|Device|FlorenceM|"The automated closed loop system (FlorenceM) will consist of:
~Next generation sensor augmented Medtronic insulin pump 640G (Medtronic Minimed, CA, USA) incorporating the Medtronic Enlite 3 family real time CGM and glucose suspend feature.
~An Android smartphone containing the Cambridge model predictive algorithm and communicating wirelessly with the insulin pump using a proprietary translator device."
16050285|NCT02523131|Device|Medtronic insulin pump 640G|Next generation sensor-augmented Medtronic insulin pump 640G (Medtronic Minimed, CA, USA) incorporating the Medtronic Enlite 3 family real time CGM. Glucose suspend features will be turned off.
16050286|NCT02523105|Device|EEG monitoring|"EEG evaluation will be done using two off the shelf EEG devices for research and consumer use. The first one is a device called MindWave by NeuroSky ltd (http://neurosky.com) the second called EPOC by Emotiv ltd (https://emotiv.com/epoc.php).
~EEG evaluation will be conducted for a total duration of 20 minutes with and without auditory stimulation. The auditory stimulation will be performed using standard headphone or earphones to reduce external noises."
16050287|NCT02523092|Drug|Acthar gel|Acthar gel given IM or SQ as per package insert
16050288|NCT02523079|Behavioral|Cognitive Behavioral Group Therapy for Insomnia|
16050289|NCT02523079|Behavioral|Cognitive Behavioral Self-help Therapy for Insomnia|
16050290|NCT02523079|Behavioral|Sleep Hygiene Guidance|
16050291|NCT02523066|Device|Magna Ease|This study is non-intervention
16050292|NCT02523053|Procedure|Hepatectomy|Surgical removal of all lesions
16050293|NCT02523053|Drug|5-Fluorouracil|Surgical removal of all lesions and intraoperative controlled release 5-Fluorouracil therapy
16050294|NCT02523040|Drug|Lenalidomide|
16050295|NCT02523027|Dietary Supplement|Oral nutritional supplement (List No S691/Z0)|(List No S691/Z0)
16050296|NCT02523027|Dietary Supplement|Oral nutritional supplement|(List No- P968/Z0)
16050297|NCT02523027|Other|Dietary Counselling|Regular dietary counseling conducted by a trained hospital dietitian.
16050298|NCT02523014|Drug|Vismodegib|Given PO
16050299|NCT02523014|Drug|FAK Inhibitor GSK2256098|Given PO
16050300|NCT02523014|Drug|Capivasertib|Given PO
16050301|NCT02523014|Drug|Abemaciclib|Given PO
16050302|NCT02522988|Behavioral|Open-label placebo intervention|An open-label placebo intervention is an administered placebo that is fully disclosed to participants. It is delivered with a script that tells participants they are receiving placebos; placebos have been found to have effects that are comparable to some clinical treatments; placebos work because of conditioning, expectancies, interactions with care team and biochemical factors (i.e., dopamine, endorphins). Participants are given placebos to take for a 3-week period and will not receive placebos for a 4-week period (including a one-week washout period).
16050303|NCT02522975|Drug|EPIAO®|"Recombinant human erythropoietin falls under the pharmacological class of haematopoietic / anti anaemic agents. It has been developed for the treatment of anaemia in subjects with chronic kidney disease.
~Erythropoietin, also known as EPO, is a glycoprotein hormone that controls erythropoiesis, or RBC production. It is a cytokine (protein signalling molecule) for erythrocyte precursors in the bone marrow. Human EPO has a molecular weight of 34,000."
16050304|NCT02522975|Drug|EPREX®|"Recombinant human erythropoietin falls under the pharmacological class of haematopoietic /anti anaemic agents. It has been developed for the treatment of anaemia in subjects with chronic kidney disease.
~Erythropoietin, also known as EPO, is a glycoprotein hormone that controls erythropoiesis, or RBC production. It is a cytokine (protein signalling molecule) for erythrocyte precursors in the bone marrow. Human EPO has a molecular weight of 34,000."
16050305|NCT02522962|Behavioral|GroupCoreSIT|"Each group session lasts for 60 minutes. The physiotherapist will chose from an exercises bank of 32 exercises, each having up 5 levels of difficulty that are described and illustrated by photos. All exercises demand core activation, emphasise normal movement and emphasise somatosensory integration, feed forward and feed back strategies essential for balance.10-12 repetitions for each exercise with good quality of movement will be performed. Every session will start with exploring standing balance and end with active stretching/active relaxation, re-exploring balance and instructions for home exercises. The participants will perform 30-minute of exercises, optional to divide into smaller intervals, at home two days per week when there are no organized group training."
16050306|NCT02522962|Behavioral|Standard care|The control group receive standard care, which means to follow their ordinary physiotherapy services and/or routines/activities. The content of standard care may vary, and will be recorded for all the participants.
16050307|NCT02522949|Device|ColdZyme® mouth spray|
16050308|NCT02522949|Device|Placebo|
16050309|NCT02522936|Drug|Biotene oral spray|Biotene oral spray will be provided to participants.
16050310|NCT02522923|Other|Physical Therapist|The participant will receive an evaluation and intervention from a physical therapist. The patient will be referred onward to other providers as needed.
16050311|NCT02522923|Other|Primary Care Provider|The participant will receive an evaluation and intervention from a primary care provider. The patient will be referred onward to other providers as needed.
16050312|NCT02522910|Drug|BAY 1000394 (Roniciclib) in combination with docetaxel|The study (Phase Ib part and Phase II part) will be conducted as a single center study. This study part will be conducted in an open-label, non-randomized, Phase I conventional 3+3 dose-escalating design to define the safety, tolerability, pharmacokinetics, and MTD of BAY 1000394 (Roniciclib) given in a 3 days on / 4 days off schedule in combination with docetaxel in subjects with second- or third-line NSCLC.
16050313|NCT02522897|Drug|Ranibizumab|
16050314|NCT02522897|Device|Laser|
16050315|NCT02522884|Device|Tack Endovascular System|Repair of post-PTA dissections using the Intact Vascular Tack Endovascular System.
16050318|NCT02522858|Drug|Atropine|"To evaluate the effectiveness of atropine on prevention bradycardia,atropine 0.01~0.03mg/kg up to 0.5mg would be injected intravenously just before starting loading dose of dexmedetomidine in group A.
~During operation, heart rate decreasing 30% from initial heart rate or under 40/min would be regarded as bradycardia needing treatment, and atropine 0.5mg will be injected intravenously. This intervention would be applied to both group."
16050319|NCT02522858|Drug|Dexmedetomidine|Dexmedetomidine is a highly selective a2 adrenergic receptor antagonist used as sedative agent. After confirming the fixation level of spinal anesthesia, the loading dose(0.6ug/kg) of dexmedetomidine which is diluted with normal saline as 4ug/mL would be started for 10 minutes.Maintenance dose(0.25ug/kg/hr) would be continued after loading dose.
16050320|NCT02522858|Drug|Ephedrine|Systolic blood pressure decreasing 30% from basal blood pressure or under 90 mm Hg would be regarded as hypotension needing treatment, and ephedrine 5mg will be injected intravenously.
16050321|NCT02522845|Device|Class II Compression Stockings (no specific device used)|This study will be looking at the effect of compression therapy in patients having endothermal treatment for truncal incompetence of their varicose veins
16050322|NCT02522832|Other|Titre 1|Virus infection
16050323|NCT02522832|Other|Titre 2|Virus infection
16050324|NCT02522832|Other|Titre 3|Virus infection
16050325|NCT02522819|Device|CPAP|Use of CPAP over 5 nights for the treatment of obstructive sleep apnea in the acute phase of stroke.
16050326|NCT02522806|Procedure|endometrial biopsy|Endometrial biopsy (EB) between J17 and J22 of previous ovarian hyperstimulation cycle
16050327|NCT02522793|Other|No intervention; this is an observational study|
16050328|NCT02522780|Drug|Mesalamine|Pharmaceutical form: Granules in sachet; Route of administration: Oral use
16050329|NCT02522780|Drug|Placebo|Pharmaceutical form: Granules in sachet; Route of administration: Oral use
16050330|NCT02522767|Drug|Mesalamine|
16050331|NCT02522767|Drug|Placebo|
16050332|NCT02522754|Biological|Placebo Protesomal Vaccine|Intranasal vaccine Protesomal Vaccine
16050333|NCT02522754|Biological|Experimental: Protesomal Vaccine 1 x 30 µg|Experimental: Protesomal Vaccine 1 x 30 µg
16050334|NCT02522754|Biological|Experimental: Protesomal Vaccine 2 x 30 µg|Experimental: Protesomal Vaccine 2 x 30 µg
16050335|NCT02522754|Biological|Experimental: Protesomal Vaccine 2 x 15 µg|Experimental: Protesomal Vaccine 2 x 15 µg
16050336|NCT02522741|Behavioral|Parenting STAIR|Parenting-STAIR is an adaptation of a 16 session study therapy entitled Skills Training in Affective and Interpersonal Regulation/Modified Prolonged Exposure (STAIR/MPE). It generally is comprised of approximately 23 sessions and includes seven didactic interaction parenting sessions. There are threskill building in areas such as e modules within Parenting STAIR: 1) Module 1 focuses on skill building (awareness of emotional states, management of negative feelings, regulation of emotional intensity, etc.); 2) Module 2 involves the processing of memories of trauma and creating a coherent and meaningful life narrative; 3) Module 3 includes both the mother and child, and focuses on increasing maternal attunement and improving parenting skills.
16050337|NCT02522728|Device|Triathlon CR|Implantation of Knee Prosthesis
16050338|NCT02522728|Device|Triathlon PS|Implantation of Knee Prosthesis
16050339|NCT02522715|Drug|Cabazitaxel|Given IV
16050340|NCT02522715|Drug|Enzalutamide|Given PO
16050341|NCT02522715|Other|Laboratory Biomarker Analysis|Correlative studies
16050342|NCT02522715|Other|Pharmacological Study|Correlative studies
16050343|NCT02522715|Drug|Prednisone|Given PO
16050344|NCT02522702|Other|Photography of polyps, resection of polyps|Ther is no study specific intervention. Still images will be taken if polyps are found in the colon. Polyps will then be resected routinely.
16050345|NCT02522689|Procedure|Endoscopic kidney stone surgery|Ultra-mini PCNL will be performed.
16050346|NCT02522689|Procedure|Endoscopic kidney stone surgery|Micro PCNL will be performed.
16050347|NCT02522676|Procedure|Endoscopic kidney stone surgery|Conventional PCNL will be performed.
16050348|NCT02522676|Procedure|Endoscopic kidney stone surgery|Mini PCNL will be performed.
16050349|NCT02522676|Procedure|Endoscopic kidney stone surgery|Ultra-mini PCNL will be performed.
16050350|NCT02522676|Procedure|Endoscopic kidney stone surgery|Micro PCNL will be performed.
16050351|NCT02522676|Procedure|Endoscopic kidney stone surgery|Retrograde intrarenal surgery will be performed.
16050352|NCT02522676|Procedure|Non-invasive kidney stone treatment|Extracorporeal shock wave will be performed.
16050353|NCT02522663|Other|24/7-telephone support|ICU nurses answer the calls from treated AVR patients during the first month after discharge, and use an evidence-based information manual to answer questions from the patients.
16050354|NCT02522650|Drug|Amiloride|5mg twice a day for 8 weeks
16050355|NCT02522650|Drug|Triamterene|50mg twice a day for 8 weeks
16050356|NCT02522637|Other|Exercise training|"The workout will start with a workload of 50% of the theoretical maximum Watts indirectly assessed by the 6-Minutes Walking Test (6MWT) with equation of Luxton et al. Each training session will begin with three minutes of warm-up and cool-down with a low load.
~At the end of each session, the physiotherapist will administer the Borg Scale (i.e. for dyspnea and muscle fatigue) and detect the oxygen saturation. The sessions will be conducted at constant load for 25 minutes and increase following the Maltais protocol (the workload increase in the next session will be 10 W, if dyspnea and muscle fatigue, evaluated at the Borg Scale, were each < 5 ).
~The patients will perform a supervised 20-min light warm-up gym exercise before the endurance training session. The training will be carried out with the oxygen level necessary to maintain the saturation level ≥ 91%."
16050357|NCT02522624|Behavioral|Decision Aid (DA)|Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of health insurance plans in addition to usual care.
16050359|NCT02522598|Drug|VVZ-149 injections|Colorless, transparent liquid in water for injection
16050360|NCT02522598|Drug|Placebo|water for injection
16050361|NCT02522585|Other|Conservative management|Control of CIN-II with cytology and colposcopy to try to avoid unnecessary surgery
16050475|NCT02521805|Other|Animal protein|
16050363|NCT02522572|Drug|Bortezomib|Bortezomib will be given via IV push over 3-5 seconds and administered based on group assignment.
16050364|NCT02522572|Other|plasmapheresis|Plasmapheresis will be administered based on group assignment.
16050365|NCT02522559|Other|Spice Intervention|Spice Intervention:Novel herb and spice blends will be used in cafeteria recipes.
16050366|NCT02522546|Other|nasopharyngeal swab|nasopharyngeal swab
16050367|NCT02522533|Other|Physical Therapy|6 weeks of an exercise program.
16050368|NCT02522520|Behavioral|Pedometer intervention|12 weeks physical activity intervention (supervised/non-supervised)
16050369|NCT02522520|Behavioral|Pedometer + hospital based intervention|12 weeks physical activity intervention (supervised/non-supervised)
16050370|NCT02522520|Device|Omron Walking Style pro. 20|
16050371|NCT02522507|Behavioral|Empowering youth towards employment|Experimental: Empowering youth towards employment This is a behavioural e-mentor intervention. Trained mentors will facilitate employment readiness learning and engage youth in discussions over a 12-week period. Each week the mentors will introduce a new employment topic and will engage youth in a discussion and answer questions.
16050372|NCT02522494|Behavioral|Pamphlet|An educational intervention delivered prior to patients' visits with primary care physicians.
16050373|NCT02522494|Behavioral|Video|An educational intervention delivered prior to patients' visits with primary care providers.
16050374|NCT02522481|Drug|Lumason|Lumason (sulfur hexafluoride-type A microspheres) an ultrasound contrast agent was administered as 2 single 2-mL IV injections during rest and stress echocardiography
16050375|NCT02522468|Procedure|Radioactive Seed Localization|
16050376|NCT02522468|Procedure|Wire Localization|
16050377|NCT02522455|Other|Flow-cycle ventilation|Pressure support level set as per previous pressure requirements to deliver a tidal volume of 5ml/kg (the same pressure amount used as the peak inspiratory pressure in the time-cycled mode)
16050378|NCT02522455|Other|Time-cycle ventilation mode|Peak inspiratory pressure set to deliver 5ml/kg tidal volume, Rate set as per previous requirements
16050379|NCT02522442|Device|CPAP|Continuous positive airway pressure
16050380|NCT02522442|Device|Auto BiLevel|Auto Bilevel positive airway pressure with Flex
16050381|NCT02522429|Device|Low Intensity Focused Ultrasound Device|Low Intensity Focused Ultrasound Pulsation (LIFUP) of thalamus (a key area for the consciousness network) will be performed during two sessions (one occurring after deep sedation is stopped and the second one occurring just before discharge). The proposed experiment will involve behavioral (i.e., CRS-R) and paramedical (i.e., MRI/fMRI and EEG) measurements just before and after each of the two LIFUP sessions (i.e., 5 non-consecutive minutes of stimulation in each session).
16050382|NCT02522416|Device|Central corneal thickness measurement|
16050383|NCT02522403|Procedure|Rehabilitation|The investigators will be apply fake laser therapy in the patients with distal radius fracture, with the device in an off position; plus the patients will be teaching to do rehabilitation exercise in flexion, extension, pronation and supination of the wrist and forearm, and to do cubital and radial deviation exercise. The investigators delivered to all patients a graphic demonstration of the exercise
16050384|NCT02522403|Device|Low Lever Laser acupuncture|The investigators will be used a low lever laser device, to apply in ten selected acupuncture points, each point will be irradiated for 30 seconds at 8000 Hz, this therapy is useful for tissue regeneration and stimulate the acupuncture points, plus an antinociceptive effect.
16050385|NCT02522390|Other|Research activities|"Measurements are primarily based on do-it-yourself non-invasive or minimally invasive methods. Participants upload collected data to the Personal Health Portal.
~The measurements are divided into required and optional measurements. The required measurements mainly include routine methodology (e.g. weight, blood pressure, blood glucose); the latter also include methods under development that will be fine-tuned along the project. Which additional measures will be offered to participants is dependent on if funding or in-kind sponsoring is available. Participants will receive measurement kits for these analyses at-home and will be responsible for collection, labeling and shipment of samples themselves. After analysis the resulting data are uploaded to the user accounts."
16050386|NCT02522377|Drug|Ketamine|inter venous injections
16050387|NCT02522377|Drug|Midazolam|inter venous injections
16050388|NCT02522364|Device|BioMonitor device|Implantation of a BioMonitor device and continuously monitoring heart rhythm for study duration
16050389|NCT02522364|Other|Standard|Clinical and intermittent electrocardiographic follow-up of patients
16050390|NCT02522351|Other|Cereal extract concentration 1|Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem
16050391|NCT02522351|Other|Cereal extract concentration 2|Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem
16050392|NCT02522351|Other|Cereal extract concentration 3|Cereal extract will be given to see the effect on penetration and aspiration in patients with dysphagia problem
16050393|NCT02522351|Other|Thicken up clear concentration 1|Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem
16050394|NCT02522351|Other|Thicken up clear concentration 2|Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem
16050395|NCT02522351|Other|Thicken up clear concentration 3|Thicken up clear will be given to see the effect on penetration and aspiration in patients with dysphagia problem
16050396|NCT02522338|Drug|iohexol|10 ml de l'iohexol (300 mgI/ml)
16050397|NCT02522325|Drug|Phendimetrazine|Phendimetrazine will be administered in divided doses twice daily.
16050398|NCT02522325|Drug|Cocaine|Intranasal cocaine will be administered during experimental sessions.
16050399|NCT02522325|Drug|Placebo|Placebo capsules will contain only cornstarch.
16050400|NCT02522312|Other|No Intervention|No drug is administered in this study
16050401|NCT02522299|Drug|GSK2269557|GSK2269557 500 mcg blended with lactose per blister and will be administered using a DISKUS dry powder inhaler device. Since GSK2269557 will no longer be manufactured for use with the DISKUS device, it will be replaced with ELLIPTA Device. Subjects will receive GSK2269557 700 mcg once daily for 84 consecutive days via ELLIPTA.
16050402|NCT02522299|Drug|Placebo|Lactose will be administered using a DISKUS and ELLIPTA dry powder inhaler device
16050403|NCT02522299|Device|DISKUS|It is multi-dose dry powder inhaler containing one foil strip of drug with 60 blisters
16050404|NCT02522299|Device|ELLIPTA|It is multi-dose dry powder inhaler containing one foil strip of drug with 30 blisters
16050405|NCT02522286|Behavioral|Ask 3 Questions|"Participants were asked to bring an Ask 3 questions flyer into their appointment to use if they needed to make a choice about their health care during their appointment. These 3 questions have been shown to help patients make more informed decisions about their healthcare."
16050406|NCT02522286|Behavioral|Open Communication|"Open Communication includes a combination of interventions. 1) Participants used a Visit Companion Booklet to write out issues they would like to discuss with their physician during their appointment before showing up. They were also asked to write out any next steps decided on during their appointment and to repeat back to their doctor what they wrote before leaving.
~2) Patients watched a short, informational cartoon video to better understand the Visit Companion Booklet.
~3) Participating physicians received a training through the use of a Standardized Patient Instructor as a means of providing convenient, individualized training on communication techniques. Dyads (physicians and their medical assistants) were trained on how to incorporate the Visit Companion Booklet into workflow."
16050407|NCT02522273|Device|EKF Diagnostics 'SensPoint' Lactate Meter|
16050408|NCT02522260|Other|Resistance and aerobic training|Group 1) includes strength exercise of the large muscle groups (2-3 sets, 8-12 repetitions on an intensity of 80 % of 1-RM) and 3x3 min high intensity aerobic exercise (16-18 on Borg scale) on an exercise bike or treadmill twice a week for 16 weeks
16050409|NCT02522260|Other|Aerobic training|Group 2) includes aerobic exercise on an exercise bike or treadmill, 20 min moderate intensity (13-15 on Borg scale), and 3x3 min high intensity (16-18 on Borg scale) twice a week during 16 weeks
16050410|NCT02522260|Other|Standard supportive care|Standard supportive care
16050411|NCT02522247|Procedure|UPP|surgery with cold steel in general anesthesia
16050412|NCT02522234|Biological|F-627 240 μg/kg|F-627 at 240 μg/kg dose enrolling 6 patients with breast cancer receiving adjuvant chemotherapy. Subjects will receive a corresponding dose of F-627 by subcutaneous injection 24 hours after each cycle（21 days） of chemotherapy drug administration. Blood samples are then collected at multiple time points during follow-up visits to evaluate the pharmacokinetics, pharmacodynamics, and safety of the drug. Dose will remain unchanged throughout the treatment period. Eligible subjects will be enrolled sequentially into the 240 μg/kg arm. And the arm should contain 6 evaluable subjects.
16050413|NCT02522234|Biological|F-627 320 μg/kg|F-627 at 320 μg/kg dose enrolling 6 patients with breast cancer receiving adjuvant chemotherapy. Subjects will receive a corresponding dose of F-627 by subcutaneous injection 24 hours after each cycle（21 days） of chemotherapy drug administration. Blood samples are then collected at multiple time points during follow-up visits to evaluate the pharmacokinetics, pharmacodynamics, and safety of the drug. Dose will remain unchanged throughout the treatment period. Eligible subjects will be enrolled sequentially into the 320 μg/kg arm. The arm should contain 6 evaluable subjects.
16050414|NCT02522221|Drug|Warfarin|Warfarin is an oral vitamin K antagonist anticoagulant.
16050415|NCT02522221|Drug|tecarfarin|Tecarfarin is an oral vitamin K antagonist anticoagulant
16050416|NCT02522208|Drug|BiDil XR|fixed combination capsule
16050417|NCT02522208|Drug|BiDil Immediate Release (IR)|fixed combination tablet
16050418|NCT02522182|Behavioral|Nurse-led Intensive Secondary Prevention Programme|Information related to intervention description have been already included in arm/group description
16050419|NCT02522182|Behavioral|Usual Treatment|Information related to intervention description have been already included in arm/group description
16050420|NCT02522169|Drug|Infliximab|"This is a randomized, prospective, parallel -controlled study, simple blinded and multicenter designed. Study centers are the Department of Child and Adolescent Medicine of the Ernst von Bergmann Hospital, Potsdam, and the Department of Child and Adolescent Medicine of Charité, Berlin.
~We estimate a sample size of 50 patients per center. Study inclusion begins with given consent of the patient and the legal guardian. Patients will be randomized in control- and intervention group separately for Cohn's disease. An equal age and gender distribution is targeted for both control and intervention group. Sub groups will be formed depending on the time span from completed Infliximab induction to study enrollment (group A< 6month, group B < 6 month). Observation period is one year."
16050421|NCT02522156|Behavioral|Looming Vulnerability Induction|guided imagery aimed at inducing smoking cessation attempts. See description of the looming vulnerability arm.
16050422|NCT02522156|Behavioral|Control|Neutral guided imagery scenarios making no reference to smoking.
16050423|NCT02522143|Behavioral|Informational sessions describing BPD characteristics|Control intervention consists of informational sessions describing BPD characteristics/ treatment and time- / stress-management skills
16050424|NCT02522143|Behavioral|Condensed-DBT treatment intervention|The Intervention consists of an 8-week manual based psychoeducational group utilizing modified condensed-DBT Treatment manual previously used in a treatment study (Moen et al, 2012).
16050425|NCT02522130|Drug|Lidocaine|intracervical injection
16050426|NCT02522130|Drug|oral misoprostol|oral treatment
16050427|NCT02522130|Drug|naproxen|oral treatment
16050428|NCT02522130|Other|placebo|oral treatment
16050429|NCT02522117|Drug|Atorvastatin|Patients were assigned to two groups; one of them received oral atorvastatin (study group), and the other homologated placebo (control group) for 4 weeks before transplant. Then IL2, IL6, TNFalpha and HLA levels were assessed in the recipient's kidney graft by visual analog scale at prior reperfusion, and after 3 and 12 months.
16050430|NCT02522117|Drug|Placebo|Patients were assigned to two groups; one of them received oral atorvastatin (study group), and the other homologated placebo (control group) for 4 weeks before transplant. Then IL2, IL6, TNFalpha and HLA levels were assessed in the recipient's kidney graft by visual analog scale at prior reperfusion, and after 3 and 12 months.
16050431|NCT02522104|Drug|Siklos|
16050432|NCT02522091|Device|functional brain MRI|
16050433|NCT02522091|Other|Neuropsychology tests|
16050434|NCT02522078|Drug|dry misoprostol|400 µg of dry misoprostol will be introduced into the vaginal fornices 3 or more hours before uterine evacuation
16050435|NCT02522078|Drug|wet misoprostol|400 µg of wet misoprostol will be introduced into the vaginal fornices 3 or more hours before uterine evacuation
16050436|NCT02522052|Other|Blue mussel diet|5 meals a week containing blue mussels
16050437|NCT02522052|Other|Meat/Control diet|5 meals a week containing meat
16050476|NCT02521805|Other|Vegetable protein|
16050438|NCT02522039|Drug|Latanoprost|1 drop of latanoprost was given to study eye after washout period of 1 week between drugs
16050439|NCT02522039|Drug|Timolol|1 drop of timolol was given to study eye after washout period of 1 week between drugs
16050440|NCT02522039|Drug|Dorzolamide|1 drop of dorzolamide was given to study eye after washout period of 1 week between drugs
16050441|NCT02522013|Drug|Aminophylline|
16050442|NCT02522013|Drug|isotonic saline|
16050443|NCT02521987|Procedure|8mm port|Participate in this arm will have their procedure performed with an 8mm laparoscopic port.
16050444|NCT02521987|Procedure|12mm port|Participate in this arm will have their procedure performed with a 12mm laparoscopic port.
16050445|NCT02521974|Biological|SABIN monovalent OPV2|SABIN monovalent OPV2 is a licensed, monovalent, live attenuated poliomyelitis virus vaccine of the Sabin strain Type 2 (P 712, Ch, 2ab), propagated in MRC5 human diploid cells. Each two-drop dose (0.1 mL) contains not less than 105.0 CCID50 of Type 2
16050446|NCT02521961|Other|Informational Intervention|Watch a Chair-robics DVD
16050447|NCT02521961|Other|Informational Intervention|Receive community resource booklet
16050448|NCT02521961|Other|Quality-of-Life Assessment|Ancillary studies
16050449|NCT02521961|Other|Questionnaire Administration|Ancillary studies
16050450|NCT02521961|Procedure|Support Group Therapy|Attend support group sessions
16050451|NCT02521948|Device|MANTA Vascular Closure Device|The MANTA device developed by Essential Medical, Inc., is a vascular closure device (VCD) intended for use in catheterization laboratories following percutaneous cardiac or peripheral procedures that use the retrograde common femoral artery access route for large bore (10-18F) interventional devices.
16050452|NCT02521935|Device|Complete traditional dentures|"Arm 1-Standard Treatment Sequence for Traditional Removable Dentures in a Dental School Clinic (9 Appointments):
~Appointment 1: Examination & diagnosis & initial impressions.
~Appointment 2: Secondary impressions.
~Appointment 3: Secondary or definitive impressions (Often 2 appointments are needed to border mold and impression)
~Appointment 4: Maxillo-mandibular jaw relation records (both centric and vertical relation). Tooth selection.
~Appointment 5: Wax-trial denture try-in.
~Appointment 6: Insertion and instructions for care of definitive prostheses.
~Appointments 7-9 Post adjustments"
16050453|NCT02521935|Device|Complete CADCAM dentures|"Arm 2-Standard Treatment Sequence for Digital Dentures in a Dental School Clinic (5 appointments):
~Appointment 1: Exam, diagnosis, & tray selection (begin impressions)
~Appointment 2: Definitive impressions and Maxillomandibula relations
~Appointment 3: Wax-trial arrangement
~Appointment 4: Insertion and instructions for care of definitive prosthesis
~Appointment 5: Post adjustment/s (Less post insertion adjustments are anticipated due to CADCAM milling of the denture base and less polymerization shrinkage"
16050454|NCT02521922|Device|VSP System - NEHB Configuration|VSP System - NEHB Configuration will take and record participant vital signs. NEHB is the last name of the physician who developed the configuration. It is not an acronym.
16050455|NCT02521922|Device|VSP System - PAL Configuration|VSP System - PAL Configuration will take and record patient vital signs. PAL is the name created by the engineering team of this device. It is not an acronym.
16050456|NCT02521909|Device|ProMark (Tooth Extraction for Assessment of Different Apex Locators)|The purpose of this study is to compare the accuracy of different apex locators on teeth that are scheduled for extractions. Before root canal therapy, dentists use a device called an electronic apex locator (EAL) to measure the root canal and to locate its opening at the tip of the tooth's root (called the apical foramen). A root canal is the space inside the root of a tooth. If the tissue within the root canal becomes infected, dentists may perform root canal therapy.
16050457|NCT02521909|Device|Root ZX II (Tooth Extraction for Assessment of Different Apex Locators)|The purpose of this study is to compare the accuracy of different apex locators on teeth that are scheduled for extractions. Before root canal therapy, dentists use a device called an electronic apex locator (EAL) to measure the root canal and to locate its opening at the tip of the tooth's root (called the apical foramen). A root canal is the space inside the root of a tooth. If the tissue within the root canal becomes infected, dentists may perform root canal therapy.
16050458|NCT02521909|Device|NRG Rider (Tooth Extraction for Assessment of Different Apex Locators)|The purpose of this study is to compare the accuracy of different apex locators on teeth that are scheduled for extractions. Before root canal therapy, dentists use a device called an electronic apex locator (EAL) to measure the root canal and to locate its opening at the tip of the tooth's root (called the apical foramen). A root canal is the space inside the root of a tooth. If the tissue within the root canal becomes infected, dentists may perform root canal therapy.
16050459|NCT02521896|Device|Steerable Sheath System|The Vado™ Steerable Sheath consists of a dilator and steerable sheath which are designed to provide intracardiac access and flexible catheter positioning in the cardiac anatomy.
16050460|NCT02521883|Device|Sooma tDCS|2mA current applied for 30 minutes in electrode locations F3 (anode) and F4 (cathode).
16050461|NCT02521883|Device|Sham tDCS|sham stimulation (current phased off after 20 secs) applied for 30 minutes in electrode locations F3 (anode) and F4 (cathode).
16050462|NCT02521870|Drug|SD-101(1)|SD-101 administered intratumorally at escalating doses (up to 11 doses).
16050463|NCT02521870|Biological|Pembrolizumab|Pembrolizumab administered intravenously, 200 mg Q3W for two years (up to 35 doses).
16050464|NCT02521870|Drug|SD-101(2)|Dose Q1W for 4 weeks followed by dose Q3W for 7 weeks, then 9 weeks off, then dose Q1W for 4 weeks followed by dose Q3W for 7 weeks (up to 22 total doses).
16050465|NCT02521870|Biological|Pembrolizumab|Pembrolizumab administered intravenously, 200mg Q3W for two years (up to 35 doses).
16050466|NCT02521870|Biological|SD-101(3)|Dose Q1W for 4 weeks followed by dose Q3W for 16 additional weeks (up to 20 total doses).
16050467|NCT02521870|Biological|Pembrolizumab|Pembrolizumab administered intravenously, 200mg Q3W for two years (up to 35 doses).
16050468|NCT02521857|Drug|ALKS 5461|Sublingual tablet administered followed by consumption of 240 mL (8 ounces) of water at different timepoints
16050469|NCT02521844|Drug|ETC-1922159|Oral administration
16050470|NCT02521844|Drug|Pembrolizumab|IV administration
16050471|NCT02521831|Drug|Spinal Anesthesia (bupivacaine)|Bupivacaine is an amide-type, long-acting local anesthetic. Brand names include Exparel, Marcaine, and Sensorcaine.
16050472|NCT02521831|Drug|General Anesthesia (isoflurane)|Isoflurane is a fluorinated ether with general anesthetic and muscle relaxant effects. Brand names include Forane and Terrell.
16050477|NCT02521805|Other|Dietary fiber (cereal food matrice)|
16050478|NCT02521805|Other|Dietary fiber (meat food matrice)|
16050479|NCT02521805|Other|Dietary fiber (vegetable food matrice)|
16050480|NCT02521792|Drug|Palovarotene|Palovarotene will be taken orally once daily at approximately the same time each day. Powder filled hard gelatin capsules may be opened and the contents added onto specific food.
16050481|NCT02521779|Other|Low-fat Treatment Meal|Isocaloric test meal that provided 20% fat.
16050482|NCT02521779|Other|Saturated-fat Treatment Meal|Isocaloric test meal that provided 35% fat with saturated fat (16 g).
16050483|NCT02521779|Other|N-3 fat Treatment Meal|Isocaloric test meal that provided 35% fat with n-3 (DHA = 500mg)
16050484|NCT02521779|Other|N-6 fat Treatment Meal|Isocaloric test meal that provided 35% fat with n-6 (7.4 g).
16050485|NCT02521766|Device|Harmoni Modular Intraocular Lens|Two-component system consisting of a base and a separate optic that allows for an intraoperative exchange of the optic only without direct manipulation of the capsular bag
16050486|NCT02521766|Device|Commercially Available Intraocular Lens|IOL per investigator's standard of care
16050487|NCT02521766|Procedure|Optic exchange|Removal of one optic and replacement with another for the purpose of improving refractive outcomes
16050488|NCT02521753|Drug|Metformin|Intervention also includes weight reduction diet and exercise therapy
16050489|NCT02521753|Dietary Supplement|Magnesium|Intervention also includes weight reduction diet and exercise therapy
16050490|NCT02521753|Dietary Supplement|PUFA|Intervention also includes weight reduction diet and exercise therapy
16050491|NCT02521740|Other|Research questionnaires, blood sample|assessment of health (frailty, nutrition, physical performance, depression, burden, sense of coherence, caregiver reaction)
16050492|NCT02521714|Drug|Lenalidomide|
16050493|NCT02521701|Drug|NFL101|"Level 1: 100 µg
~50 µg per injection (in each arm), two injections at day 1 and two injections at day 29
~The 140 µg must be diluted in 2.8 mL of dilution solution in order to obtain a 50 µg.mL-1 concentration.
~Level 2: 200 µg
~100 µg per injection (in each arm), two injections at day 1 and two injections at day 29
~The 140 µg must be diluted in 1.4 mL of dilution solution in order to obtain a 100 µg.mL-1 concentration. Therefore, for this level only, two vials are needed to inject 2 x 1.0 mL."
16050494|NCT02521688|Procedure|incisional biopsy from placenta and GCF sample|A small piece of villous placental tissue (approximately 1 cm3) will be dissected free of maternal decidua from the placental bed after delivery of fetus processed to prepare tissue homogenate according to the standardized technique (Keelan JA, et al. 1999) GCF will be obtained from each patient by filter paper inserted in gingival crevice for few seconds after isolation by cotton.
16050495|NCT02521675|Behavioral|Usual algorithm|"The patient will be fitted with a CGMS (continuous glucose monitoring system) (data not shown) and it will be given the booklet to collect events + food survey
~The patient goes home and he must perform 3 physical activities during the week (30-60 minutes) using its usual algorithms (glucose administration or adaptation of the BR), in the afternoon, and spacing them at least 24 hours :
~Moderate activity 3 hours after lunch
~Intense activity 3 hours after lunch
~Moderate activity 90 min after lunch These activities should not exceed 1 hour in wherever possible"
16050496|NCT02521675|Behavioral|Diabrasport algorithm|"The patient will be fitted with a CGMS (data not shown) and it will be given the booklet to collect events + food survey
~The patient goes home and he must perform 3 physical activities during the week (identical to those carried out during the week test algorithms usual and during comparable periods) using DIABRASPORT algorithms, the afternoon and in the spacing at least 24 hours:
~Moderate activity 3 hours after lunch
~Intense activity 3 hours after lunch
~Moderate activity 90min after lunch These activities shall not exceed one hour"
16050497|NCT02521675|Behavioral|Rest|"The patient will be fitted with a CGMS (data not shown) and it will be given the booklet to collect events + food survey.
~The patient goes home and he will not perform any physical activity during the week"
16050498|NCT02521675|Device|Holter Glycemic Ipro2, Medtronic|
16050499|NCT02521662|Drug|Nicotine patch|A transdermal patch that slowly releases nicotine into the body through the skin.
16050500|NCT02521662|Device|e-cigarette|A electronically powered device that delivers to the user an aerosol of propylene glycol and/or glycerine, with or without flavourings and nicotine.
16050501|NCT02521662|Drug|Nicotine|Nicotine contained in e-liquid (e-juice) used in e-cigarettes
16050502|NCT02521662|Behavioral|Behavioural support|Withdrawal-oriented behavioural support
16050503|NCT02521649|Drug|G17DT|
16050504|NCT02521636|Other|Antibiotic therapy randomization|
16050505|NCT02521636|Other|Serum PCT dosage|
16050506|NCT02521623|Device|SurgiMend® Acellular Dermal Matrix|See arm description.
16050507|NCT02521623|Device|Strattice™ Acellular Dermal Matrix|See arm description.
16050508|NCT02521610|Drug|Placebo|Participants will receive the placebo equivalent to RG7625 once or twice daily for 8 days. The first dose will be administered on Day 1 and the regimen will be continued during Days 3 to 9, with only a single dose given on Day 9.
16050509|NCT02521610|Drug|RG7625|Participants will receive RG7625 as oral capsules once or twice daily for 8 days. The first dose will be administered on Day 1 and the regimen will be continued during Days 3 to 9, with only a single dose given on Day 9.
16050510|NCT02521597|Device|Cellscope|The CellScope Oto, is a portable video-otoscope that allows residents and staff to share diagnostic-quality images
16050511|NCT02521597|Device|Traditional otoscope|Use of a regular otoscope
16050512|NCT02521571|Behavioral|Resiliance Alliance|"The intervention is 6 months long & is delivered through weekly sessions held in the participating child protective offices. The sessions follow a 4-week cycle with the participants changing each week of the cycle: (1) CPS alone, by units; (2) CPS/Supervisor units; (3) Child Protective Manager and CPS/Supervisor units; and (4) CPSs & Supervisors/Managers separately.
~Participating staff are introduced to a resilience-related topic or skill, and receive a brief didactic training on that topic. Staff then engage in a group activity, which is designed to help them apply the new topic or skill to the workplace. Each module wraps up with a relaxation or exercise to help staff transition back into their work responsibilities; the facilitator can pick among the selection provided based on their sense of what would be helpful for the group. Staff are also given handouts and activities to do during the week."
16050546|NCT02521363|Drug|anthracycline and taxane based chemotherapy|Conventional, standard of care neoadjuvant chemotherapy delivered irrespective of device readout
16050513|NCT02521571|Behavioral|Secondary traumatic stress training|"These trainings will take place in two parts (for a total of 3 hours) and include an overview of secondary traumatic stress and its impact on child welfare staff, and some strategies staff can use to protect themselves from STS - essentially a summary version of what the intervention group will receive over the 24 weeks of the intervention. The investigators consider this training to represent treatment as usual, as from our experience it is often how child welfare agencies address the issue of secondary traumatic stress among their staff."
16050514|NCT02521558|Behavioral|Intervention Group|The investigators are interested in how practicing memory tasks can improve memory in patients with MCI and with AD. Specifically, patients will perform a set of cognitive rehabilitation tasks designed to train memory in order to determine if these tasks are effective in improving memory or slowing the progression of Alzheimer's disease. Patients will practice memory tasks for about an hour daily, for a total duration of 6 months. A research assistant or clinician will conduct weekly check-ins with each participant assess whether or not participants in the Intervention Group exhibit weekly improvements and to determine if patients are regularly adhering to the tasks.
16050515|NCT02521558|Behavioral|Control Group|"The Control Group will not receive any cognitive rehabilitation tasks for a six month period. Instead, they will simply be given booklets of puzzles (e.g., word search, number puzzles, etc.) to work on for the duration of 6 months.
~A research assistant or clinician will conduct weekly check-ins with each participant assess whether or not participants in the control group feel like they are benefiting from the puzzles.
~Participants in the Control Group will be given a standard battery of neuropsychological tests prior to the the puzzles and after the puzzles to assess any changes in memory, language, attention, and executive functioning."
16050516|NCT02521545|Drug|BIIB061|Capsule
16050517|NCT02521532|Dietary Supplement|Dietary nitrate|140ml of nitrate rich beetroot juice provides 12.9mmol nitrate and will be consumed on a daily basis during the intervention by the study subjects.
16050518|NCT02521532|Dietary Supplement|Placebo|140ml of nitrate depleted beetroot juice provides 0.5mmol nitrate and will be consumed on a daily basis during the intervention by the study subjects.
16050519|NCT02521519|Other|Medial branch block in one side|MBB: Using sterile conditions, 25G needles will be placed in the desired position. In its final position for the L3 and L4 vertebrae the needle tip should reside at the junction of the superior articular process and the transverse process. At the L5-S1 level the needle tip should reach the junction between the sacral ala and the superior articular process of S1. Following a negative aspiration 0.5ml of injectate will be injected into each site.
16050520|NCT02521519|Other|paravertebral deep intramuscular (PDI) injection|injections will target the deep para-spinal muscles between the spinous process and inter-pedicular line of the L3-5 vertebrae. Under fluoroscopic guidance, a 25-gauge needle will be advanced, directed towards the lamina at the mid-distance between inter-pedicular line and the spinous process of the L3, L4 and L5 vertebrae, until touching the bone. A straight forceps will be attached to the junction of the skin and the needle; the needle will then be withdrawn by 1.4cm, to reside inside the muscle bulk. A five ml syringe diameter will be used to point 1.4 cm withdrawal. Following a negative blood aspiration, each level will be injected with 0.5 ml of the injectate.
16050521|NCT02521506|Device|Verio Pattern Alert® activated|
16050522|NCT02521506|Device|Verio Pattern Alert® deactivated|
16050531|NCT02521480|Device|Active Transcranial Magnetic Stimulation|TMS is a non-invasive treatment. During TMS treatment, a coil, which creates a magnetic field, will be placed on the left prefrontal area of the head. Active TMS will stimulate for 4 seconds, pause for 26 seconds, and repeat this for approximately 40 minutes. There will be a total of 3000 pulses during treatment. We expect TMS to decrease pain and depression. In order to find out if this is true, we will compare real TMS with sham (inactive) TMS.This will allow us to decide if active TMS is successful because of electrical stimulation, or because of the support, concern, and understanding of the research team.
16050532|NCT02521480|Device|Sham Transcranial Magnetic Stimulation|Inactive treatment (simulation of active TMS)
16050533|NCT02521467|Biological|Platelets Rich Fibrin in healing of palatal donor tissue|Platelets Rich Fibrin (PRF) is a second generation of platelets concentrate full of growth factors as PDGF, IGF, TGF which had a role in hemostasis fasten the healing and decrease the pain.
16050534|NCT02521467|Other|Placebo|the other group is a control group, had no biologic in the palatal wound, only palatal stent
16050535|NCT02521454|Behavioral|MBRT|
16050536|NCT02521441|Biological|F-627|F-627 at doses of 10 mg/dose or 20 mg/dose, s.c. on Day 3 of each cycle for up to 4 cycles.
16050537|NCT02521441|Biological|Filgrastim|Filgrastim at dose of 5 mcg/kg/day for up to 2 weeks, s.c. start from Day 3 of each cycle for up to 4 cycles.
16050538|NCT02521428|Other|retrospective analysis|Approximately 200 patients will be enrolled in the study. They are followed up until their death on the ICU. In clinical routine end-of-life decisions are documented for decision-makers and procedures in the patients´ records. Patients´ characteristics and therapeutic approaches are documented in the electronic patient data management system.
16050539|NCT02521415|Drug|ketamine|intranasal (IN) sub-dissociative ketamine (1mg/kg)
16050540|NCT02521415|Drug|fentanyl|Intranasal (IN) fentanyl (1.5 micrograms/kg)
16050541|NCT02521415|Drug|ibuprofen or acetaminophen|10 mg/kg of ibuprofen or 15 mg/kg of acetaminophen will be given to participants prior to the randomized intervention
16050542|NCT02521402|Biological|Biovance|decellularized, dehydrated human amniotic membrane
16050543|NCT02521389|Drug|PWT-143|phosphatidylinositol-4,5-bisphosphate 3-kinase (PI3K) delta inhibitor
16050544|NCT02521376|Drug|Entospletinib|Entospletinib 100 mg tablet administered orally
16050545|NCT02521363|Device|KIBUR MICRODEVICE|This device contains 16 reservoirs, each with a unique single agent or drug combination in microdose amounts of less than one millionth of a systemic patient dose. The device is implanted directly into the tumor during a biopsy procedure, and remains in situ for ~24 hours.
16050547|NCT02521337|Other|observation|observation
16050548|NCT02521324|Device|DGB2|DGB guides its user in reducing breathing rate gradually from normal values (12-20 breaths/min) to slow rates (4-6 breaths/min) while increasing the relative duration of the exhalation phase. This is done by composing in real time musical tones from monitored respiration data with which the user synchronizes breathing .
16050549|NCT02521311|Drug|Clemastine|12mg (4mg 3x/day) clemastine for 7 days followed by 8mg clemastine (4mg 2x/day) until 3 months. Patients will be off treatment from 3-9 months and will be reevaluated at 9 months.
16050550|NCT02521311|Drug|Placebo|Equivalent placebo. 12mg (4mg 3x/day) placebo for 7 days followed by 8mg placebo (4mg 2x/day) until 3 months. Patients will be off treatment from 3-9 months and will be reevaluated at 9 months.
16050551|NCT02521298|Other|Strength Training|
16050552|NCT02521298|Procedure|Placebo|
16050553|NCT02521298|Drug|Cortico-Steroid Injection. Depomedrol 40mg/1ml.|
16050554|NCT02521298|Procedure|Dry Needling|
16050555|NCT02521285|Drug|Aspirin|Given PO
16050556|NCT02521285|Other|Laboratory Biomarker Analysis|Correlative studies
16050557|NCT02521285|Other|Placebo Administration|Given PO
16050558|NCT02521285|Other|Questionnaire Administration|Ancillary studies
16050559|NCT02521272|Other|Breathing in the simulated avalanche snow.|Breathing in the simulated avalanche snow with zero air pocket and one-liter air pocket.
16050560|NCT02521272|Device|air pocket|Zero air pocket or one-liter air pocket in the snow.
16050561|NCT02521259|Device|BIS|BIS monitoring provides the patient's depth of consciousness, enables us to monitor safe, optimal anesthesia for each patient.
16050562|NCT02521246|Drug|Candesartan + Chlorthalidone|
16050563|NCT02521246|Drug|Candesartan + Chlorthalidone|
16050564|NCT02521246|Drug|Losartan+hydrochlorothiazide|
16050565|NCT02521233|Drug|Candesartan + Chlorthalidone (8mg+12,5mg)|
16050566|NCT02521233|Drug|Candesartan + Chlorthalidone (8 mg + 25 mg)|
16050567|NCT02521233|Drug|losartan+hydrochlorothiazide|
16050568|NCT02521220|Dietary Supplement|L-citrulline|L-citrulline 2 times daily 3 gram (6g/day)
16050569|NCT02521220|Dietary Supplement|Placebo|Maltodextrin 2 times daily 3 gram (6g/day)
16050570|NCT02521207|Drug|Ibuprofen|
16050571|NCT02521194|Behavioral|Questionnaire|Questionnaire completion regarding opinion of the inpatient occupational therapy session patient received.
16050572|NCT02521181|Drug|Lower Dose Sodium Bicarbonate|Lower dose oral Sodium Bicarbonate (0.5 milliequivalents (mEq)/kg-LBW/day)
16050573|NCT02521181|Drug|Higher Dose Sodium Bicarbonate|Higher dose oral Sodium Bicarbonate (0.8 mEq/kg-LBW/day)
16050574|NCT02521181|Drug|Placebo|Oral placebo equivalent to either 0.5 mEq/kg-LBW/day or 0.8 mEq/kg-LBW/day of Sodium Bicarbonate
16050575|NCT02521168|Drug|Oral triiodothyronine|Oral triiodothyronine is given peri-operatively through naso-gastric tube
16050576|NCT02521168|Drug|Placebo|Placebo consist of saccharin lactis that has the same appearance as Tetronine
16050577|NCT02521155|Behavioral|Safeguard Your Smile an oral health literacy intervention|"Safeguard Your Smile intervention will consist of following five components:
~i) Reviewing photonovel (educational booklet) with participants to help them understand adequate oral hygiene self-care behavior. ii) Demonstrating adequate tooth brushing, flossing and tongue cleaning (frequency, duration and technique) on dentoform iii) Helping participants to make a concrete plan (specifying when where and how will they perform oral hygiene self-care behavior and a coping plan). Also, to identify a prompt/cue that would act as a reminder. iv) Assigning a task to participants to daily check-mark their behavioral progress on a calendar provided in the photonovel for the next three months. v) Follow up by making three phone calls to each participant of the intervention group once a month."
16050578|NCT02521142|Other|Non-invasive OCT based optical angiography|This measurement will be obtained after the dilation of the pupil. Optical coherence tomography (OCT) is a non-invasive optical imaging modality enabling cross-sectional tomographic in vivo visualization of internal microstructure in biological systems. In ophthalmology OCT has become a standard device in visualizing the retina and is also considered a standard tool in the diagnosis of retinal disease. In optical angiography blood vessels contrasting against static tissue are visualized in a full depth resolved and label-free manner.
16050579|NCT02521142|Other|Oxymap T1|The Oxymap system T1 is installed on a conventional fundus camera (Topcon TRC-50DX), which is operated as for color photography. The Oxymap T1 simultaneously acquires two images of the same area of the fundus at two different wavelengths of light. One of the two wavelengths is sensitive to oxygen saturation, i.e. the light absorbance changes with the oxygen saturation, while the other is insensitive to oxygen saturation and is used to calibrate the light intensity. The two spectral images are automatically processed by the Oxymap Analyzer software. Oxymap Analyzer detects blood vessels and estimates the light absorbance (optical density) at each point along the vessels at each wavelength. The ratio of the optical densities (optical density ratio or ODR) has been shown to be linearly related to hemoglobin oxygen saturation.
16050580|NCT02521142|Other|Spectralis OCT and Topcon DRI OCT|The Spectralis OCT (Heidelberg Engineering) and the high definition Topcon DRI OCT (Topcon), will be used. Both are standard OCT devices for non-invasive imaging of retinal and choroidal structures.
16050581|NCT02521142|Other|FLA/ICG angiography|Fluorescein Angiography and Indocianine Angiography
16050582|NCT02521129|Device|Biopsy Track Ablator (STARmed, Goyang, Korea)|After percutaneous ultrasound guided biopsy for hepatic masses is performed, biopsy track is ablated with a new track ablation device.
16050583|NCT02521116|Other|Dynamic Vessel Analyzer|
16050584|NCT02521116|Other|Oxymap T1|
16050585|NCT02521103|Device|Triathlon Tritanium Cone Augments|The Triathlon Tritanium Cone Augments are an extension of the Triathlon Total Stabilizer (TS) system, intended to be used as an optional accessory component in primary or revision TKA
16050586|NCT02521090|Biological|EGFRBi-Armed Autologous T Cells|Given IT and IV
16050587|NCT02521090|Other|Laboratory Biomarker Analysis|Correlative studies
16050588|NCT02521077|Drug|Ascorbic Acid|500 g ascorbic acid dissolved in 500 ml sterile water.
16050589|NCT02521077|Other|Normal Saline|Saline 0.9%
16050590|NCT02521064|Dietary Supplement|Exclusive Enteral Nutrition (EEN)|Patients will be treated with 8 weeks of Exclusive Enteral Nutrition (EEN). Patients will continue to receive usual medical care, and concurrent IBD treatments will be permitted.
16050591|NCT02521064|Drug|Prednisone|Patients will be treated with 8 weeks of prednisone (corticosteroid). Patients will continue to receive usual medical care, and concurrent IBD treatments will be permitted.
16050592|NCT02521051|Drug|Alectinib|
16050593|NCT02521051|Drug|Bevacizumab|
16050594|NCT02521038|Drug|Brilinta|90mg bid as a treatment for Acute coronary syndrome. Dose and Duration can be adjusted by the primary physician.
16050595|NCT02521025|Other|Intermittent feeding pattern|Intermittent feeding
16050596|NCT02521025|Other|Continuous feeding pattern|Continuous feeding
16050597|NCT02521012|Dietary Supplement|Vitamin D 10 micrograms|Vitamin D supplementations of 10 micrograms/day will be given to depressed individuals for three months
16050598|NCT02521012|Dietary Supplement|Vitamin D 100 micrograms|Vitamin D supplementations of 100 micrograms/day will be given to depressed individuals for three months
16050599|NCT02520999|Device|Auto PC(Acemedical, Goyang-si, Korea) - 0mmHg(control)|Blood pass through infusion set without external pressure.
16050600|NCT02520999|Device|Auto PC(Acemedical, Goyang-si, Korea) - 150mmHg|Blood pass through infusion set under external pressure (150mmHg)
16050601|NCT02520999|Device|Auto PC(Acemedical, Goyang-si, Korea) - 200mmHg|Blood pass through infusion set under external pressure (200mmHg)
16050602|NCT02520999|Device|Auto PC(Acemedical, Goyang-si, Korea) - 250mmHg|Blood pass through infusion set under external pressure (250mmHg)
16050603|NCT02520999|Device|Auto PC(Acemedical, Goyang-si, Korea) - 300mmHg|Blood pass through infusion set under external pressure (300mmHg)
16050604|NCT02520986|Device|Carbon dioxide Laser ablation|surgical Instrument to achieve excision of genital warts by a pulsed laser of 15 Watt voltage
16050605|NCT02520986|Device|Electrocoagulation|surgical Instrument to achieve excision of genital warts by a deep tissue electrocoagulation of 80 Watt voltage
16050606|NCT02520973|Other|Sputum sample|
16050607|NCT02520947|Device|BIS|Bispectral index monitoring
16050608|NCT02520947|Drug|Desflurane|volatile agent for maintenance of anesthesia
16050609|NCT02520934|Drug|Miglustat|combine miglustat and ERT to see if neurologic manifestations can be improved
16050610|NCT02520934|Drug|ERT|enzyme replacement therapy
16050611|NCT02520921|Drug|Novel strategy Aspirin|Aspirin twice a day : enteric coated enteric coated aspirin given twice a day, 100 mg in the morning and 100 mg in the evening (i.e. 200mg/day)
16050612|NCT02520921|Drug|Conventional strategy Aspirin|Aspirin once day: enteric coated aspirin 100 mg in the morning (i.e. 100mg/day)
16050613|NCT02520908|Procedure|HSCT|Hematopoietic stem cell transplantation
16050614|NCT02520908|Other|Standard Care|
16050615|NCT02520895|Biological|blood samplings|patients will have blood samplings at different time : D0: day of inclusion = day of the first course of chemotherapy or the 1st day of the confirmation of the diagnosis (group 8) M3: 3 months (+/- 1 month) after the start of treatment (except for group 8) M6: 6 months (+/- 1 month) after the start of treatment or after the 1st day of the confirmation of the diagnosis (group 8) M12 : 12 months after the start of treatment (group 6 and 7) M18: 18 months (+/- 1 month) after the start of treatment or after the 1st day of the confirmation of the diagnosis (group 8) R: to relapse if it occurs before 18 months or at the time of first treatment if it occurs before 18 months (group 8)
16050616|NCT02520882|Drug|68Ga-NOTA-Aca-BBN|68Ga-NOTA-Aca-BBN(7-14) were injected into the patients before the PET/CT scans
16050617|NCT02520882|Device|PET/CT|
16050618|NCT02520869|Procedure|swim-up technique|swim-up technique used
16050619|NCT02520869|Procedure|zeta test technique|zeta test technique used
16050620|NCT02520856|Other|blood sample|
16050621|NCT02520843|Drug|stromal vascular fraction (SVF)|stromal vascular fraction (SVF) is administered to the patient suffering of Refractory Crohn's disease around of the fistula by local mico injection
16050622|NCT02520830|Dietary Supplement|Blueberry Group|22 grams freeze-dried blueberry powder per day. Sustained intake (2x 11 grams daily over 1 month) of a drink consisting on freeze-dried wild blueberry powder dissolved in water
16050623|NCT02520830|Dietary Supplement|Placebo Group|Sustained intake (2x 11 grams daily over 1 month) of a drink consisting in placebo powder dissolved in water
16050624|NCT02520817|Dietary Supplement|175 mg zinc gluconate, 50000 IU vitamin A, 500 mg vitamin C and 100 mg vitamin E once daily plus lactulose; dose 30-60 ml/day for 3 months|
16050625|NCT02520817|Dietary Supplement|Lactulose|
16050626|NCT02520804|Drug|sterofundin|sterofundin for shock patients in the first 72 hours
16050627|NCT02520804|Drug|normal saline|Normal saline for shock patients in the first 72 hours
16050628|NCT02520791|Biological|Anti-ICOS Monoclonal Antibody MEDI-570|Given IV
16050629|NCT02520791|Other|Laboratory Biomarker Analysis|Correlative studies
16050630|NCT02520791|Other|Pharmacological Study|Correlative studies
16050631|NCT02520778|Drug|Navitoclax|Given PO
16050632|NCT02520778|Drug|Osimertinib|Given PO
16050633|NCT02520752|Drug|INC280|
16050634|NCT02520752|Drug|Midazolam|
16050635|NCT02520752|Drug|Caffeine|
16050636|NCT02520739|Dietary Supplement|Virgin Olive Oil (VOO)|VOO was sequentially administered over 3 periods of 3 weeks preceded by 2-week washout periods in which participants were requested to avoid olives and olive oil consumption. During intervention periods, they were requested to ingest a raw daily dose of 30 mL of VOO distributed over 3 meals. Daily doses of VOO were blindly prepared in special containers, with the corresponding 30 mL VOO daily dose were delivered at the beginning of each intervention period to the participants. The participants were instructed to return the containers when collecting the next daily doses for the amount of unconsumed VOO to be registered. During washout periods participants were provided of sunflower oil for raw and cooking purposes.
16050637|NCT02520739|Dietary Supplement|Optimized High Phenolic Content Oil (OHPCO)|OHPCO was sequentially administered over 3 periods of 3 weeks preceded by 2-week washout periods in which participants were requested to avoid olives and olive oil consumption. During intervention periods, they were requested to ingest a raw daily dose of 30 mL of OHPCO distributed over 3 meals. Daily doses of OHPCO were blindly prepared in special containers, with the corresponding 30 mL OHPCO daily dose were delivered at the beginning of each intervention period to the participants. The participants were instructed to return the containers when collecting the next daily doses for the amount of unconsumed OHPCO to be registered. During washout periods participants were provided of sunflower oil for raw and cooking purposes.
16050638|NCT02520739|Dietary Supplement|Functional Olive Oil (FOO)|FOO was sequentially administered over 3 periods of 3 weeks preceded by 2-week washout periods in which participants were requested to avoid olives and olive oil consumption. During intervention periods, they were requested to ingest a raw daily dose of 30 mL of FOO distributed over 3 meals. Daily doses of FOO were blindly prepared in special containers, with the corresponding 30 mL FOO daily dose were delivered at the beginning of each intervention period to the participants. The participants were instructed to return the containers when collecting the next daily doses for the amount of unconsumed FOO to be registered. During washout periods participants were provided of sunflower oil for raw and cooking purposes.
16050639|NCT02520726|Drug|Sertraline|< 65years: sertraline 50mg PO qday increasing by 50mg per day per week until 200mg for one week, then stop.
16050640|NCT02520726|Drug|Placebo oral capsule|Matched encapsulated placebo from 1-4 capsules daily
16050641|NCT02520713|Genetic|Genetic testing and GAIN report|All patients enrolled will submit specimens for genetic analysis. If successful the report will be reviewed to look for possible recommendations and a GAIN report will be generated regardless of possible recommendations.
16050642|NCT02520700|Device|Daylight and Maquet Power 500 LED surgery light|Comparing the use of daylight and a surgical light (Maquet Power 500 LED surgery light) to activate ALA cream for treatment of actinic keratoses
16050643|NCT02520687|Dietary Supplement|Beetroot juice|200mls daily for seven days
16050644|NCT02520687|Dietary Supplement|Nitrate-depleted beetroot juice|200mls daily for seven days
16050645|NCT02520674|Other|optic nerve head ophthalmoscopy|Patients underwent undilated smartphone ophthalmoscopy followed by undilated slit-lamp biomicroscopy for the grading of the vertical cup-to-disc ratio of the optic nerve head.
16050646|NCT02520661|Behavioral|Care Transitions Intervention|The Care Transitions Intervention uses coaches, in this case paramedics, to support patients being discharged home by transferring skills to activate patients.
16050647|NCT02520648|Other|Neuro-lymphatic treatment|The physical therapist applied direct firm rotary pressure, via thumb or tip finger, for 1 minute, from the transverse processes of T1 to the transverse processes of T12. To finish the intervention, hands were placed on the skull and sacrum during 2 minutes without movement.
16050648|NCT02520648|Other|Articulatory spinal manual therapy|Then the therapist performs pressures in the transverse apophysis from D1 to D12 (level of the paravertebral muscles, at a distance of 2 fingers of the spinous apophysis), applying sustained pressure during expiratory time until the articulatory barrier is reached.
16050649|NCT02520648|Other|Articulatory costal Manual therapy|The therapist performs costal-vertebral articulatory movement, from 1st to 12th rib (level of the outside paravertebral muscles, at a distance of 4 fingers from the spinous apophysis on the back of the costal body) applying a sustained pressure during expiratory time and promoting its biomechanics, up to the articulatory barrier.
16050650|NCT02520635|Drug|supra-early TEMODAL® chemotherapy|
16050651|NCT02520635|Drug|standard TEMODAL® chemotherapy|
16050652|NCT02520635|Radiation|Radiotherapy 60Gy|
16050653|NCT02520622|Behavioral|Digital photographs loaded onto a mobile device|
16050654|NCT02520622|Behavioral|Skin exam reminders|
16050655|NCT02520622|Behavioral|Social support network|
16050656|NCT02520596|Other|Bioavailability of Raspberry polyphenols|
16050657|NCT02520583|Dietary Supplement|Lactic acid bacteria and bifidobacteria|
16050658|NCT02520583|Other|Placebo|
16050659|NCT02520570|Drug|ulinastatin|We wouldn't intervene the doctors how to treat with the patients or how to use the drug, we just observe the react of patients after treated with ulinastatin.
16050660|NCT02520557|Other|Blood or Saliva|To screen for HLA genotypes that may place patients at high risk of SCAR when they use ESL.
16050661|NCT02520544|Device|Accolade stem|Total hip replacement
16050662|NCT02520544|Device|Accolade II stem|Total hip replacement
16050663|NCT02520544|Device|Trident/Tritanium cup|Total hip replacement
16050664|NCT02520531|Device|Scorpio PS (posterior stable)|Implantation of total knee prosthesis
16050665|NCT02520531|Device|Scorpio NRG PS|Implantation of total knee prosthesis
16050666|NCT02520518|Drug|Dapagliflozin|
16050667|NCT02520518|Drug|Placebo|
16050668|NCT02520518|Behavioral|Weight maintenance|
16050669|NCT02520518|Behavioral|Ad libitum dietary intake|
16050670|NCT02520518|Behavioral|Dietary restriction|
16050671|NCT02520505|Drug|Supraovulation clomiphene citrate|Treatment with clomiphene citrate during day 3 to 7 of the menstrual cycle.
16050672|NCT02520505|Behavioral|Timed intercourse|Timing intercourse during the fertile window in the menstrual cycle. Patients may also utilize an ovulation predictor kit to determine time of ovulation.
16050673|NCT02520505|Procedure|Intrauterine Insemination|Intrauterine insemination will be performed ~36 hours after the time the woman ovulates, as determined by an ovulation predictor kit.
16050674|NCT02520492|Device|noninvasive method of ICP measurements (Elios)|
16050675|NCT02520479|Drug|P-CHOP|Two cycles of P-CHOP:cyclophosphamide, 750 mg/m2 day 1; vincristine,(maximal dose 2 mg),adriamycin , 50 mg/m2 day 1; dexamethasone,10mg days 1-8; Pegaspargase, 2500IU/m2 day 1 are given before radiotherapy
16050676|NCT02520479|Radiation|Radiotherapy|Radiotherapy was scheduled after 2 cycles of P-CHOPregimen. Involved field radiotherapy(IFRT) is delivered using 6-Million electron Volts linear accelerator using 3-dimensional conformable treatment planning. The IFRT dose was 56 grays (Gy) in 28 fractions.
16050677|NCT02520479|Drug|P-CHOP|"Two consolidation cycles of P-CHOP are given after radiotherapy"
16050678|NCT02520466|Dietary Supplement|flavanol-rich drink vs flavanol-free drink|Patients will be randomized to either a flavanol-rich drink or a flavanol-free drink of similar volume, taste and calory and sugar content
16050679|NCT02520453|Drug|Durvalumab|
16050680|NCT02520453|Drug|Placebo|
16050681|NCT02520440|Biological|Monitoring of plasmatic levels of Citrulline|Measured plasma amino-acids levels
16050682|NCT02520440|Device|Intra-abdominal pressure monitoring|Intra-abdominal Hypertension is defined as an average pressure of the day ≥ 12 mmHg; abdominal compartment syndrome is defined as a sustained (minimally two standardized measurements, performed 1-6 h apart) increase in Intra-abdominal pressure above 20 mmHg with new onset organ failure.
16050683|NCT02520440|Biological|Monitoring of plasmatic levels of Arginine and Glutamine|Measured plasma amino-acids levels
16050685|NCT02520414|Device|Symphion® Bipolar Hysteroscopic Tissue Resection System|
16050686|NCT02520401|Other|Probiotic - BioGaia|Use of a probiotic tablet
16050687|NCT02520401|Other|Placebo|Use of a placebo tablet
16050688|NCT02520388|Drug|HLD200 methylphenidate hydrochloride (MPH) Capsules|HLD200 Doses: 40, 60 or 80 mg
16050689|NCT02520388|Drug|Placebo|
16050690|NCT02520375|Other|Prebiotic|
16050691|NCT02520375|Other|Control|
16050692|NCT02520362|Drug|denosumab|subcutaneous injection
16050693|NCT02520362|Drug|bisphosphonate|The assessment of bisphosphonates includes branded oral bisphosphonates (eg, alendronate [Fosamax®], risedronate [Actonel®], ibandronate [Boniva®/Bonviva®] oral); generic bisphosphonates, including alendronate, neridodronate, and olpadronate; intravenous bisphosphonates including ibandronate IV, and zoledronate [Reclast®/Aclasta®].
16050694|NCT02520349|Device|MarkTen and e-Go e-cigarettes|
16050695|NCT02520336|Behavioral|Reminder|
16050696|NCT02520323|Other|Blood draw|
16050697|NCT02520323|Procedure|Bronchoscopy|
16050698|NCT02520323|Behavioral|Questionnaires|
16050699|NCT02520310|Device|AVJ-514|Patients receiving AVJ-514 device
16050700|NCT02520297|Drug|TRV130|Drug
16050701|NCT02520284|Biological|Andecaliximab|Andecaliximab 150 mg administered via SC injection
16050702|NCT02520284|Biological|Placebo|Placebo matched to andecaliximab administered via SC injection
16050703|NCT02520271|Behavioral|Behavioral Activation|BA consists of at least 4 intervention sessions with a focused, active working style by the therapist. The therapy initiation includes a focused interview targeting at determining 1-2 main problems, on which the therapy will be focused. Specific therapeutic methods for BA include the use ABC analysis, targeting at hitting the negative consequences of current problematic behavior and motivating for change. Further, recognizing the obstacles for change (TRAP) is the next method to be used. The therapist encourages the client for active behavioral monitoring through assigned homework during the therapy process. The final step and method used is strengthening the gained change (ACTION).
16050704|NCT02520271|Behavioral|Motivational Interview|"Motivational interview (MI) is a therapeutic intervention that focuses on resolving client ambivalence towards changing problematic behavior. MI involves a client-centered approach that encourages the client to develop his or her own motivation. The therapeutic alliance in MI is predominantly a partnership, rather than an expert/client dynamic.
~MI has been studied primarily in addiction problems, but there are numerous reports of its efficacy in several chronic somatic conditions, and lifestyle problems."
16050705|NCT02520258|Other|Oral glucose tolerance test (OGTT)|OGTT will be conducted following a ten (10) hour fast on Screening Visit 2 (Screening Visit 2 may be conducted between Day -42 to Day 1).
16050706|NCT02520258|Other|Diet soda containing aspartame only|7 days of 36 oz diet soda po daily (Week 1), followed by 21 days washout (Weeks 2-4), and 7 days rechallenge (Week 5); Prudent metabolic diet; Oral glucose tolerance test (OGTT) on days (+/-2) 3, 7, 10, 14, 21, 28, 31, 35
16050707|NCT02520245|Drug|REGN2810|Patients will receive REGN2810 by intravenous (IV) infusion
16050708|NCT02520232|Behavioral|Combination of aerobic and strength exercises|Combination of aerobic and strength exercises
16050709|NCT02520232|Behavioral|Stretching and balance exercise program|Stretching and balance exercise program
16050710|NCT02520219|Drug|GDP|GDP is a a combination therapy,repeated every 21 days. GEM(gemcitabine)1000mg/m2,ivgtt,30,d1、8; DXM(dexamethasone),40mg/d,p.o,d1-4; DDP(cis-platinum),75mg/m2,ivgtt,>1h,d1; or DDP25 mg/m2,ivgtt,>1h,d1-3.
16050711|NCT02520219|Biological|Endostar|"Endostar is a continuous intravenous injection pump, continuous intravenous pumped by seven consecutive days,d1- d7, which is 168 hours .Endostar pumping well dose is 30 mg every 24 hours.
~Repeated every 21 days."
16050712|NCT02520193|Procedure|Protocolized early mobilization in ICU|
16050713|NCT02520180|Device|Firehawk™ stent system|MicroPort Firehawk™ biodegradable polymer rapamycin target eluting stent
16050714|NCT02520180|Device|Abbott Xience family Everolimus-Eluting Stent|Abbott Xience family Everolimus-Eluting Stent
16050715|NCT02520167|Behavioral|Dietary and Lifestyle Counseling|Dietary and lifestyle education; Peer group support.
16050716|NCT02520154|Drug|Carboplatin|Given IV
16050717|NCT02520154|Other|Laboratory Biomarker Analysis|Correlative studies
16050718|NCT02520154|Drug|Paclitaxel|Given IV
16050719|NCT02520154|Biological|Pembrolizumab|Given IV
16050720|NCT02520154|Other|Pharmacological Study|Correlative studies
16050721|NCT02520141|Other|Laboratory Biomarker Analysis|Correlative studies
16050722|NCT02520141|Biological|Ramucirumab|Given IV
16050723|NCT02520128|Radiation|Intensity modulated radiotherapy (IMRT)|Intensity modulated radiotherapy (IMRT) is an advanced radiotherapy technique that is able to deliver a highly conformal dose to a target with improved sparing of the surrounding normal tissues from moderate to high radiation doses. IMRT is likely to be of particular benefit for tumours that have complex shapes, or those in close proximity to sensitive normal tissues and critical organs. Reducing the dose to normal tissues may in turn reduce the acute and late side effects of treatment. IMRT can be delivered from multiple fixed beam angles or through rotational arc applications such as volumetric modulated arc therapy (VMAT) and tomotherapy. The radiotherapy is delivered using multiple small beams (beamlets) of non-uniform intensity.
16050724|NCT02520115|Drug|Dexamethasone|Given PO
16050725|NCT02520115|Other|Laboratory Biomarker Analysis|Analysis of serum and tissue samples
16050726|NCT02520115|Drug|Valproic Acid|Given PO
16050727|NCT02520102|Drug|sargramostim GZ402664|"Pharmaceutical form: lyophilized powder in vial
~Route of administration: subcutaneous"
16050728|NCT02520089|Procedure|bone autograft of iliac crest|The investigators will take bone autograft of iliac crest of the patient and then apply into the site of pseudoarthrosis, this graft have osteogenic, osteoinductive and osteoconductive properties
16050729|NCT02520089|Procedure|Platelet Rich Plasma plus bone autograft|Sample of 40 mL of peripheric blood and processed to obtain 5 mL of platelet rich plasma, and collocated into pseudoarthrosis
16050766|NCT02519829|Procedure|Tegaderm dressing|Total Hip Arthroplasty with monocryl closure of wound and tegaderm dressing
16051159|NCT02517229|Other|balance control measurements|
16050730|NCT02520076|Drug|Alpha-1 Antitrypsin|"Subjects will receive their islets treated with Aralast NP during islet isolation process.
~Subjects will receive Aralast NP at a dose of 120 mg/kg (at an infusion rate of 0.2 mL/kg/min or less), dependent on patient tolerance, based on Day -1 admission weight and dose rounded to the nearest 20 mg) at the following time points:
~Pre-transplant Day -1
~Post-transplant Day 3
~Post-transplant Day 7
~Post-transplant Day 14"
16050731|NCT02520063|Drug|Letrozole|A dose of 2.5 mg of letrozole will be given orally once each day until one day before surgery. This drug is commercially available and is not provided by the study.
16050732|NCT02520063|Drug|Everolimus|The dose of everolimus will be escalated from 5 mg to 10 mg daily depending upon the cohort in Phase I. It is administered as an oral pill to be taken once daily up until four weeks prior to surgery.
16050733|NCT02520063|Drug|TRC105|The dose for TRC105 is either 15 or 10 mg/kg to be given intravenously every two weeks and continued until four weeks prior to surgery.
16050734|NCT02520050|Behavioral|Traditional MNT|Will follow the nutritional recommendations set by the American Diabetes Association in 2013.
16050735|NCT02520050|Behavioral|Structured MNT|Will follow a meal plan developed at Joslin plus use of use of diabetes-specific nutritional formula.
16050736|NCT02520050|Behavioral|Structured MNT plus Weekly Support|Will follow a meal plan developed at Joslin plus use of use of diabetes-specific nutritional formula; in addition to receiving weekly coaching from a registered dietitian
16050737|NCT02520024|Behavioral|self-directed care|
16050738|NCT02520011|Drug|Alvocidib|
16050739|NCT02520011|Drug|Cytarabine|
16050740|NCT02520011|Drug|Mitoxantrone|
16050741|NCT02519998|Other|Concussion|Study groups are differentiated based on presence of concussion. No intervention is being made in either population (observational study)
16050742|NCT02519985|Device|ArcScan Insight 100 very high-frequency digital ultrasound|"The ArcScan Insight 100 VHF digital ultrasound scanner that can measure individual layers within the cornea with very high precision, as well as being able to image the interior of the eye including the chamber between the iris and the cornea, the lens and other structures behind the iris.
~The ArcScan Insight 100 device is a digital ultrasound scanner, meaning that it uses ultrasound waves to measure parameters of the eye. The Insight examination involves the patient sitting in front of the ultrasound unit and looking through a disposable goggle-like eyepiece at a light source. Warm sterile balanced saline solution (like natural tears) are used to fill the space between the light source and the eye, to allow ultrasound transmission. There is no contact between the instrument and the eye other than being immersed in this water bath."
16050743|NCT02519972|Device|low dose computed tomography|Participants will receive 3 round of low dose computed tomography screening every year
16050744|NCT02519946|Other|On-Line Diet and Exercise Intervention|Initial 16 weeks of on-line, live exercise instruction 3x/week and on-line, diet sessions followed by 16 weeks of weekly exercise and diet sessions.
16050745|NCT02519933|Procedure|mNT-BBAVF|mNT-BBAVF was performed under local anesthesia. A transverse incision of approximately 4 cm was made in the antecubital area. The basilic vein was isolated, and its side branches were ligated; followed by the isolation of brachial artery. A venotomy of 5 mm was performed, followed an arteriotomy of 5 mm. The two vessels then had a side-to-side anastomosis, followed by the ligation of the vein above anastomosis. All the perforating veins located in an area 2-4 cm down the antecubital fossa from anastomosis were separated and ligated carefully. After surgeries, all patients will be followed up for 12 months. The outcomes are patency (primary unassisted patency and secondary), complications and hemodynamic parameters (diameters, blood velocities and blood volume) detected by Ultrasound.
16050746|NCT02519933|Procedure|BCAVF|BCAVF was performed under local anesthesia. A transverse incision of approximately 4 cm in length was made in the medial antecubital area. The cephalic vein was isolated, followed by the isolation of brachial artery. The distal end of cephalic vein was ligated and dissected. Patency of the proximal vein was verified by the warmed saline injection. The artery was then incised after clamping, and an end-to-side anastomosis (4-0 silk suture) between the cephalic vein and the brachial artery was performed. At last the skin is sutured (1-0 silk suture). At last the skin is sutured. After surgeries, all patients will be followed up for 12 months. The outcomes are patency (primary unassisted patency and secondary), complications and hemodynamic parameters detected by Ultrasound.
16050747|NCT02519920|Drug|fluorescein sodium 0.01ml/kg|fluorescein Sodium Dose of 0.01ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin
16050748|NCT02519920|Drug|fluorescein sodium 0.02ml/kg|fluorescein Sodium Dose of 0.02ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin
16050749|NCT02519920|Drug|fluorescein sodium 0.05ml/kg|fluorescein Sodium Dose of 0.05ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin
16050750|NCT02519920|Drug|fluorescein sodium 0.1ml/kg|fluorescein Sodium Dose of 0.1ml/kg on confocal laser endoscopy image quality and yellow discoloration of the skin
16050751|NCT02519894|Behavioral|Dietary Scanning Calculator|
16050752|NCT02519881|Procedure|Microfracture|simple microfracture of ankle
16050753|NCT02519881|Device|CartiFill|add collagen when doing microfracture
16050754|NCT02519868|Device|Electrical block|Nerve stimulator switched on at an intensity of 5 mA for 15 minutes, with the needle tip positioned close to the carotid bifurcation with the aid of the echography
16050755|NCT02519868|Device|Chemical block|Injection of lidocaine 1%, 15 mLs, with the needle tip positioned close to the carotid bifurcation, with the aid of the echography
16050756|NCT02519855|Biological|ZOSTAVAX™|A single blinded administration of 0.65 mL subcutaneous injection on Day 1 (concomitant) or at Week 4 (nonconcomitant)
16050757|NCT02519855|Biological|Placebo to ZOSTAVAX™|A single blinded administration of 0.65 mL subcutaneous injection on Day 1 (nonconcomitant) or at Week 4 (concomitant)
16050758|NCT02519855|Biological|Influenza Vaccine|A single open-label administration of 0.5 mL intramuscular injection on Day 1
16050759|NCT02519842|Drug|Fosaprepitant|
16050760|NCT02519842|Drug|Placebo for fosaprepitant|
16050761|NCT02519842|Drug|Ondansetron|
16050762|NCT02519842|Drug|Dexamethasone|
16050763|NCT02519842|Drug|5-HT3 antagonist|
16050764|NCT02519829|Procedure|Monocryl closure|Total Hip Arthroplasty with monocryl closure of wound
16050765|NCT02519829|Procedure|Vicryl and Staple closure|Total Hip Arthroplasty with vicryl and staple closure of wound
16051160|NCT02517229|Device|electromagnetic maneuverable postural platform|
16050767|NCT02519829|Procedure|Gauze dressing|Total Hip Arthroplasty with vicryl and staple closure of wound and gauze dressing
16050768|NCT02519816|Other|Autologous peripheral blood mononuclear cells ex vivo depleted for reactive T cells, using TH9402 based photodynamic therapy, in a final formulation of 10% DMSO, 30% autologous plasma in PlasmaLyte.|
16050769|NCT02519777|Drug|Placebo for maraviroc (MVC)|Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen
16050770|NCT02519777|Drug|Placebo for dolutegravir (DTG)|Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen
16050771|NCT02519777|Drug|Dolutegravir (DTG)|Administered orally as one 50 mg tablet BID OR one 50 mg tablet QD depending upon background ARV regimen
16050772|NCT02519777|Drug|Maraviroc (MVC)|Administered orally as one 150 mg tablet BID OR two 300 mg tablet BID OR one 300 mg tablet BID depending upon background ARV regimen
16050773|NCT02519764|Other|Hydration when thirsty.|Volunteers in this arm habitually follow a hydration protocol that advises hydration when thirst is felt.
16050774|NCT02519764|Other|Not hydration when thirsty|"Volunteers in this arm habitually follow any other kind of hydration protocol, i.e. not a hydration when thirsty protocol."
16050775|NCT02519751|Dietary Supplement|D3 Creatine|One dose of D3 Creatine (60mg capsule) given orally on Day 1
16050776|NCT02519751|Dietary Supplement|Creatine|Participants will consume an individual dosed level of creatine, based on their estimated muscle mass in doses of 0.03, 0.035, 0.04, 0.045 g.kg.Lean mass/day, increasing on a weekly basis. Final dose of 0.05 g.kg.Lean mass/day is then maintained throughout the study.
16050777|NCT02519738|Drug|Silver Nitrate|Silver nitrate to be applied 3 times weekly for a period of 3 weeks.
16050778|NCT02519738|Drug|Kenalog (Triamcinolone)|Triamcinolone will be applied as an ointment to the granulation tissue site three times daily for a total of three weeks.
16050779|NCT02519738|Other|Washcloth Abrasion|Gentle wash and abrasion with washcloth done once daily for a total of 3 weeks.
16050780|NCT02519725|Other|ICU diary|The intervention is the elaboration of an ICU diary by caregivers and families The first pages of the diary is standardized to include an explanation of the purpose of the diary. The diary is maintained by the family and ICU staff. The only instruction given to the families and staff members about diary entries is to refrain from writing about confidential matters that could not be shared among the patients, the staff and the relatives. Staff members are free to express compassion and their hope, or absence thereof, that the patient would recover. Relatives can speak freely with the patients without receiving guidance from the ICU staff. At the minimum, the ICU staff write a brief entry at each weekly staff meeting. For patients discharged to wards and if he can receive the diary, the diary is given to the patient. If the patient died, the diary is given to the family.
16050781|NCT02519712|Drug|Induction Chemotherapy|Patients with newly diagnosed AML will receive standard induction chemotherapy with daunorubicin and cytarabine (7+3 scheme). Patients who achieve CR may undergo consolidation chemotherapy at the discretion of the treating leukemia physician.
16050782|NCT02519712|Procedure|G-PBSC Infusion|G-CSF-mobilized peripheral blood cells will be collected from the donors in the Donor Room according to standard MSKCC BMT guidelines. Patients will be infused by infusion of unmanipulated G-PBSC from a haploidentical related donor.
16050783|NCT02519699|Drug|norepinephrine|Increase in mean arterial pressure using norepinephrine
16050784|NCT02519673|Device|Measurement of stromal tissue ablation|Stromal tissue consumption will be estimated preoperatively by WaveLight Allegretto EX-500 laser and central corneal thickness will be measured by Pentacam. One month after refractive surgery, during follow-up,central corneal thickness will be again measured by Pentacam.
16050785|NCT02519660|Drug|Lidocaine/Tetracaine patch|
16050786|NCT02519660|Drug|Lidocaine/Prilocaine cream|
16050787|NCT02519647|Device|Tracheal intubation with Gliderite|Tracheal intubation with Gliderite
16050788|NCT02519647|Device|Tracheal intubation with S-guide|Tracheal intubation with S-guide
16050789|NCT02519634|Procedure|Super-Mini Percutaneous Nephrolithotomy|Patients undergo Super-Mini Percutaneous Nephrolithotomy
16050790|NCT02519634|Procedure|Retrograde Intrarenal Surgery|Patients undergo Retrograde Intrarenal Surgery
16050791|NCT02519621|Device|NPWT PRO without irrigation|NPWT PRO without irrigation.
16050792|NCT02519621|Device|NPWT PRO with irrigation|NPWT PRO with irrigation (saline)
16050793|NCT02519621|Device|KCI Ulta|KCI Ulta NPWT without irrigation
16050794|NCT02519608|Drug|Aspirin 100 mg|Patients with COPD and SCAD undergoing PCI and stent implantation will receive aspirin
16050795|NCT02519608|Drug|Ticagrelor|Patients with COPD and SCAD undergoing PCI and stent implantation will receive according randomization aspirin + ticagrelor (loading dose 180 mg + maintenance 90 mg x2)
16050796|NCT02519608|Drug|Clopidogrel|Patients with COPD and SCAD undergoing PCI and stent implantation will receive according randomization aspirin + clopidogrel (loading dose 600 mg + maintenance 75 mg)
16050797|NCT02519595|Drug|Ketamine IV 1mg/kg|Intervention: Ketamine IV 1mg/kg
16050798|NCT02519595|Drug|Ketamine IV 1.5mg/kg|Intervention: Ketamine IV 1.5 mg/kg
16050799|NCT02519595|Drug|Ketamine IV 2mg/kg|Intervention: Ketamine IV 2 mg/kg
16050800|NCT02519582|Drug|Niclosamide|2 g per day orally
16050801|NCT02519569|Other|Internet-based cognitive-behavioral therapy|The intervention consists of ten writing assignments
16050802|NCT02519556|Drug|Probiatop|Dilute one sachet in 100ml of water and take it in every morning, once a day for 6 months.
16050803|NCT02519556|Drug|Placebo|1 sachet, once a day for 6 months. Dilute one sachet in 100ml of water and take it in every morning.
16050804|NCT02519543|Drug|Placebo|Placebo to be given twice daily, once with breakfast and once with supper
16050805|NCT02519543|Drug|Metformin|Active experimental drug to be given twice a day, 1000 mg with breakfast and 1000 mg with supper
16050806|NCT02519530|Behavioral|Teen Outreach Program|The Teen Outreach Program (TOP) is a positive youth development program that uses weekly educational peer group sessions, Community Service Learning (CSL), and positive adult guidance to help youth in grades 6-12 build healthy behaviors, life skills, and a sense of purpose. For this study, TOP was implemented in traditional public high schools in Florida and delivered by local health department staff, who were trained and certified as TOP facilitators. Youth enrolled in these classes received the TOP intervention in addition to, not as a replacement for, all business-as-usual curriculum content.
16050807|NCT02519517|Procedure|Permissive hypercapnia|During one lung ventilation, right ventricular function was assessed by transesophageal echocardiography (TEE) and the effect of increased carbon dioxide pressure was evaluated
16050808|NCT02519491|Other|Modified Allen Test|The Modified Allen's Test (MAT) will be performed in a well-lit room on both of the participant's hands. This technique will involve compression of both the radial and ulnar arteries by the investigator to assess patency of the contralateral artery. The participant will then be asked to clench and open their hand several times. The participant will then be asked to maintain their hand in an open position. The investigator will then release the compression over the ulnar artery and observe for palmar blush. The length of time to achieve maximal palmar blush will be recorded. This technique will then be repeated by maintaining compression over the ulnar artery and releasing of the compression over the radial artery.
16050809|NCT02519491|Other|Iphone artery assessment|The iRADIAL iPhone app (Heart Rate, Azumio software) will be used to assess radial and ulnar artery patency. Briefly, the iPhone camera will be placed over the participant's thumb and patency assessed before and immediately following isolated contralateral artery compression for a maximum of two minutes.
16050810|NCT02519478|Behavioral|Helmetless Tackling Training (HuTT)|see previous sections
16050811|NCT02519465|Other|10l/min|For inhalation was used diethilene penta-acetic triamine technetium (99mTc-DTPA) with radioactivity of 1 millicuries (Noble et al., 2007) and 0.9% saline solution with a total volume of 1 ml using vibrating mesh inhaler (Aerogen Ltd, Galway , Ireland) with the respiratory care system for the high flow ( Fisher & Paykel healthcare, New Zealand) and nasal cannula (Fisher & Paykel healthcare, New Zealand) with flow 10l/min
16050812|NCT02519465|Other|30l/min|For inhalation was used diethilene penta-acetic triamine technetium (99mTc-DTPA) with radioactivity of 1 millicuries (Noble et al., 2007) and 0.9% saline solution with a total volume of 1 ml using vibrating mesh inhaler (Aerogen Ltd, Galway , Ireland) with the respiratory care system for the high flow ( Fisher & Paykel healthcare, New Zealand) and nasal cannula (Fisher & Paykel healthcare, New Zealand) with flow 30l/min.
16050813|NCT02519465|Other|50l/min|For inhalation was used diethilene penta-acetic triamine technetium (99mTc-DTPA) with radioactivity of 1 millicuries (Noble et al., 2007) and 0.9% saline solution with a total volume of 1 ml using vibrating mesh inhaler (Aerogen Ltd, Galway , Ireland) with the respiratory care system for the high flow ( Fisher & Paykel healthcare, New Zealand) and nasal cannula (Fisher & Paykel healthcare, New Zealand) with flow 50l/min.
16050814|NCT02519452|Drug|Daratumumab Subcutaneous (SC) Administration|Participants will receive Daratumumab mixed with rHuPH20 in part 1 and co-formulated with rHuPH20 in part 2 and part 3 administered via SC administration once weekly in Cycles 1 (each cycle is 28 days) and 2, every 2 weeks in Cycles 3-6, and every 4 weeks in subsequent cycles.
16050815|NCT02519452|Drug|Recombinant Human Hyaluronidase [rHuPH20]) SC Administration|Participants will receive Recombinant Human Hyaluronidase [rHuPH20]) mixed with Daratumumab in part 1 and co-formulated with Daratumumab in part 2 and part 3 administered as SC administration once weekly in Cycles 1 (each cycle is 28 days) and 2, every 2 weeks in Cycles 3-6, and every 4 weeks in subsequent cycles.
16050816|NCT02519439|Drug|ganaxolone|225 mg capsules 450 mg to 900 mg 2x/day
16050817|NCT02519426|Procedure|Mandibular third molar surgery|Mandibular third molar surgery is a mandibular wisdom tooth removal procedure in which surgical access is required to completely remove a tooth. Even if the tooth is visible in the mouth without surgically exposing it, surgical techniques may be necessary to remove the tooth. This includes sectioning the tooth into two or more pieces, corticotomy, and removal with forceps and elevators, whether or not a soft tissue incision is made.
16050818|NCT02519413|Drug|dimethyl fumarate|delayed release capsules
16050819|NCT02519400|Drug|Amitriptyline|Single oral dosing
16050820|NCT02519387|Drug|Buprenorphine Transdermal Patch|
16050821|NCT02519374|Drug|Placebo (including Maltodextrin)|
16050822|NCT02519374|Drug|PROMITOR® (including Maltodextrin)|Investigational product dose 1
16050823|NCT02519374|Drug|PROMITOR® (including Maltodextrin)|Investigational product dose 2
16050824|NCT02519374|Drug|PROMITOR® (including Maltodextrin)|Investigational product dose 3
16050825|NCT02519348|Biological|Durvalumab + tremelimumab|Durvalumab will be administered by IV infusion in combination with tremelimumab.
16050826|NCT02519348|Biological|Durvalumab|Durvalumab will be administered by IV infusion.
16050827|NCT02519348|Biological|Tremelimumab|Tremelimumab will be administered by IV infusion.
16050828|NCT02519348|Biological|Durvalumab + Bevacizumab|Durvalumab will be administered by IV infusion in combination with bevacizumab
16050829|NCT02519335|Drug|Dexrazoxane|Dose escalation every 4 subjects from 200mg/m2/dose; 300mg/m2/dose to 400mg/m2/dose
16050830|NCT02519322|Biological|Ipilimumab|Given IV
16050831|NCT02519322|Other|Laboratory Biomarker Analysis|Correlative studies
16050832|NCT02519322|Biological|Nivolumab|Given IV
16050833|NCT02519322|Biological|Relatlimab|Given IV
16050834|NCT02519322|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16050835|NCT02519309|Other|Virta Program|
16050836|NCT02519296|Behavioral|Prolonged Exposure Therapy|8 sessions with prolonged exposure therapy and fMRI.
16050837|NCT02519296|Behavioral|Observation|fMRI.
16050838|NCT02519296|Device|fMRI|Functional Magnetic Resonance Imaging of the brain
16050839|NCT02519283|Behavioral|GUIDED-HF|"Participants in this arm will receive a tailored discharge plan via a transition nurse coordinator directed team (TNC Team).
~Disease education: Health literacy screen will identify barriers to understanding discharge and medication instructions.
~Lifestyle interventions: Includes receiving smoking cessation information and instructions to track daily weights.
~Guideline recommendations for medications and device referral: Includes determining the need for prescriptions for ACEIs, ARBs, beta blockers, aldosterone antagonists, anticoagulants and referral for pacemaker/defibrillator consideration.
~Outpatient follow-up appointment: TNC Team will provide a scheduled appointment within 7 days and will conduct a home visit within 48 hours of ED discharge."
16050840|NCT02519283|Behavioral|Standard of Care|"Those in the standard care arm will receive structured ED discharge assessment to include:
~discharge instructions;
~medication reconciliation
~encourage follow-up."
16050841|NCT02519270|Biological|IGN002|IGN002 is a monoclonal antibody fusion protein.
16050889|NCT02518932|Drug|Last 5 amino acids of GLP-1|To examine insulinomimetic properties of LVKGR
16050890|NCT02518932|Drug|placebo saline|
16050842|NCT02519257|Procedure|CAD|Patients with CAD diseases proposed to have cardiac operations will be enrolled in this study, but those with congestive heart failure are excluded. Besides, those patients with valve diseases should have patent coronary arteries on coronary angiography.
16050843|NCT02519257|Procedure|VHD|Patients with valve diseases proposed to have cardiac operations will be enrolled in this study, but those with congestive heart failure are excluded. Besides, those patients with valve diseases should have patent coronary arteries on coronary angiography.
16050844|NCT02519244|Device|Ekso® (Wearable lower limb exoskeleton)|The wearable lower limb exoskeleton is a powered, robotic lower limb exoskeleton with actuated hips and knees. A control algorithm has been implemented in this device, which allows for provision of assistance to lower limb segments during movement, dependent on user needs.
16050845|NCT02519231|Drug|Naproxen|Naproxen 440mg 1x pid
16050846|NCT02519231|Drug|Placebo|Placebo tablet 440mg 1x pid
16050847|NCT02519218|Device|Ellipse Technologies Intramedullary High Tibial Osteotomy Nail System|
16050848|NCT02519205|Other|Survey|
16050849|NCT02519192|Device|V.A.C.Ulta™ Negative Pressure Wound Therapy System|VAC Arm will consist of a group of patients assigned to VAC negative pressure therapy with regular sponge irrigation with normal saline (the V.A.C.Ulta™ Negative Pressure Wound Therapy System) .
16050850|NCT02519192|Procedure|Vac sponge irrigations|VAC Arm will consist of a group of patients assigned to VAC negative pressure therapy with regular sponge irrigation with normal saline (the V.A.C.Ulta™ Negative Pressure Wound Therapy System) .
16050851|NCT02519192|Procedure|ostomy bag|Non Vac Arm will receive ostomy bag applications.
16050852|NCT02519192|Procedure|wet to dry dressings|Non Vac arm will receive wet to dry dressing changes.
16050853|NCT02519179|Behavioral|Opaque, weighted bottle|This is the experimental condition; mothers will be asked to feed their infants from an opaque, weighted bottle.
16050854|NCT02519179|Behavioral|Clear, conventional bottle|This is the control condition; mothers will be asked to feed their infants from a clear, conventional bottle.
16050855|NCT02519166|Biological|1 clinical examination of the wound, 1 sample taken with the curette, 1 sample by swabbing|
16050856|NCT02519153|Drug|Sildenafil|placebo will take nitrofuratoin once daily for 4 weeks . sildenafil arm will take sildenafil 50 mg once daily for 4 weeks
16050857|NCT02519140|Drug|Cook Medical EMR Gel|Cook Medical EMR Gel will be injected submucosally into ex-vivo gastric or colonic tissue specimens
16050858|NCT02519127|Other|Low glycaemic load diet|Subjects will first be subjected to a 2-week run-in diet consisting of products that fit into a typical 'Western' diet. Thereafter subjects will be allocated to a low glycemic load diet for 6 weeks.
16050859|NCT02519127|Other|Western diet|Subjects will first be subjected to a 2-week run-in diet consisting of products that fit into a typical 'Western' diet. Thereafter subjects will be allocated to a 'Western' diet for 6 weeks.
16050860|NCT02519114|Procedure|Donor Bone Marrow stem cell transplantation|KIR-mismatched haploidentical Bone Marrow stem cell transplantation
16050861|NCT02519101|Device|continuous noninvasive blood pressure monitoring ClearSight-Device|Noninvasive continuous blood pressure monitoring using the volume clamp method (ClearSight-Device)
16050862|NCT02519075|Other|No intervention|Observational study
16050863|NCT02519062|Other|No intervention|This is a retrospective study
16050864|NCT02519049|Other|No intervention|This is an observational study
16050865|NCT02519036|Drug|ISIS 443139 10 mg|ISIS 443139, 10 mg, was administered by intrathecal injection, on Study Days 1, 29, 57, and 85.
16050866|NCT02519036|Drug|ISIS 443139 30 mg|ISIS 443139, 30 mg, was administered by intrathecal injection, on Study Days 1, 29, 57, and 85.
16050867|NCT02519036|Drug|ISIS 443139 60 mg|ISIS 443139, 60 mg, was administered by intrathecal injection, on Study Days 1, 29, 57, and 85.
16050868|NCT02519036|Drug|ISIS 443139 90 mg|ISIS 443139, 90 mg, was administered by intrathecal injection, on Study Days 1, 29, 57, and 85.
16050869|NCT02519036|Drug|ISIS 443139 120 mg|ISIS 443139, 120 mg, was administered by intrathecal injection, on Study Days 1, 29, 57, and 85.
16050870|NCT02519036|Other|Placebo|Placebo was administered by intrathecal injection, on Study Days 1, 29, 57, and 85.
16050871|NCT02519023|Drug|Liposomal Bupivacaine|In one arm the TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine injected followed by 20 mL of a 50:50 mixture of liposomal bupivacaine and normal saline. This will then be repeated on the contralateral side.
16050872|NCT02519023|Drug|Bupivacaine|Surgical Infiltration of the study solution will be performed both prior to incision and at the end of surgery just prior to closure of incisions. At each time, the surgeon will inject 5 mL of 0.25% bupivacaine into each of the port site incisions.
16050873|NCT02519023|Device|Ultrasound|An ultrasound, which is a beam of high frequency sound that allows one to visualize images in the body, will be used to aid investigators to observe the local anesthetic being infiltrated into the plane
16050874|NCT02519023|Drug|Epinephrine|TAP infiltration will contain 10 mL of 0.25 % bupivacaine with epinephrine.
16050875|NCT02519023|Drug|acetaminophen|all individuals will receive scheduled acetaminophen (1 gram every 6 hours),
16050876|NCT02519023|Drug|ibuprofen|all individuals will receive scheduled ibuprofen (800 mg every 8 hours)
16050877|NCT02519023|Drug|Oxycodone|all individuals will receive PRN oxycodone 5-10mg q4h if pain is rated at more than 5 out of 10 on a numerical pain scale.
16050878|NCT02519010|Drug|Amlodipine/Valsartan|1 tablet contains Amlodipine 10 mg &valsartan 160 mg
16050879|NCT02519010|Drug|Exforge|1 tablet contains Amlodipine 10 mg &valsartan 160 mg
16050880|NCT02518997|Other|Parental Reading Aloud|Infants will be exposed to parental reading aloud or to a recording of the parent's voice reading during times of cardio-respiratory monitoring.
16050881|NCT02518971|Drug|Tamsulosin|0.4 mg daily
16050882|NCT02518971|Drug|Placebo|one capsule daily
16050883|NCT02518958|Drug|RRx-001|
16050884|NCT02518958|Drug|Nivolumab|
16050885|NCT02518945|Drug|Dapagliflozin|Dapagliflozin or Farxiga is a SGLT-2 inhibitor
16050886|NCT02518945|Drug|Insulin|
16050887|NCT02518945|Drug|Liraglutide|Victoza(Liraglutide) is a GLP-1 agent.
16050888|NCT02518945|Drug|Dapagliflozin placebo|Dapagliflozin placebo looking similar to active drug Dapagliflozin in external appearance but not containing active ingredient dapagliflozin
16051161|NCT02517216|Other|parabolic flight|
16050891|NCT02518919|Other|Child life intervention|The participants will receive IV ketamine for sedation. In addition in this arm, 'Child Life Intervention', comfort measures provided by a trained child life therapist during painful procedures.
16050892|NCT02518919|Other|Music listening|The participants will receive IV ketamine for sedation. In addition in this arm, 'Music Listening' to music chosen by the patient using headphones
16050893|NCT02518906|Behavioral|Adolescent Identity Treatment|"Integrative Approach for the treatment of adolescents with Personality Disorder.
~Manual was published in 2013."
16050894|NCT02518906|Behavioral|DBT-A|Dialectic Behavioral Treatment for Adolescents is the most commonly used Approach for the Treatment of adolescents with Boderline Personality Disorder
16050895|NCT02518893|Other|Demographic Data|Demographic data will be collected from up to 50 service members who have participated in health research or who have previously declined research participation.
16050896|NCT02518893|Other|Interview|Up to 40 service members will participate in individual, in-depth, semi-structured interviews in person or via telephone.
16050897|NCT02518880|Other|Parabolic flight|
16050898|NCT02518880|Other|plasma volume measurements|
16050899|NCT02518867|Other|high intensity iTBS|In intermittent theta burst stimulation pattern (iTBS) will intermittently give a 2 s train of TBS every 10s for a total of 20 times (high intensity , 100% of active motor threshold) TBS for 3 days.
16050900|NCT02518867|Other|low intensity iTBS|In intermittent theta burst stimulation pattern (iTBS) will intermittently give a 2 s train of TBS every 10s for a total of 20 times (low intensity, 80% of active motor threshold) TBS for 3 days.
16050901|NCT02518867|Other|sham iTBS|In sham burst stimulation pattern (sham TBS) will intermittently give a sham TBS treatment.
16050902|NCT02518841|Device|ThermaWedge TM|ThermaWedge TM is a foam wedge device that is designed to be used in the treatment of plantar fasciopathy.
16050903|NCT02518841|Other|Achilles Tendon Stretching|Participants will be asked to perform achilles tendon stretching exercises which will be demonstrated at the initial orientation.
16050904|NCT02518828|Other|High SpO2|SpO2 range ≥96%
16050905|NCT02518828|Other|Low SpO2|SpO2 range 90-92%
16050906|NCT02518815|Device|3M Bair Paws Warming System|20 minutes of prewarming immediately pre-operatively using 3M Bair Paws warming system
16050907|NCT02518802|Drug|Gefitinib|Gefitinib 250mg per day for 2 years.
16050908|NCT02518802|Drug|Pemetrexed|Pemetrexed, 500mg/m2, day 1; Cisplatin 75mg/m2, day 1. Three weeks as a cycle. Four cycles in total.
16050909|NCT02518789|Drug|Low-dose Dexmedetomidine|Pretreatment：Intravenous injection dexmedetomidine 0.5 µg/kg ，completed within 15 minutes.
16050910|NCT02518789|Drug|High-dose dexmedetomidine|Pretreatment：Intravenous injection dexmedetomidine 1 µg/kg ，completed within 15 minutes.
16050911|NCT02518789|Drug|normal saline|Pretreatment：Intravenous injection normal saline equal quantity，completed within 15 minutes.
16050912|NCT02518789|Drug|Etomidate|"After 90 seconds of Pretreatment，intravenous infusion of etomidate fat emulsion 0.3mg/kg.
~-Does not offer any other drugs within 5 min after completion of etomidate."
16050913|NCT02518789|Drug|midazolam，fentanyl，rocuronium|Anesthesia induction：Intravenous injection midazolam 0.03 ~ 0.05 mg/kg, fentanyl 5 ~ 8 g/kg, rocuronium 0.6 mg/kg
16050914|NCT02518789|Drug|propofol，remifentanil，cis atracurium|Anesthesia maintenance：Intravenous infusion of propofol 4 ~ 6 mg/kg/h, remifentanil 0.1 ~ 0.3 μg/kg/min, intermittent intravenous injection of cis atracurium 0.05 ~ 0.1mg/kg
16050915|NCT02518776|Behavioral|Neuropsychological tests|Neuropsychological tests
16050916|NCT02518763|Drug|Vitamin D3, 100 000 IU weekly, 4 times|
16050917|NCT02518763|Biological|25 OH vitamin D serum concentration measurements|
16050918|NCT02518750|Drug|Dexamethasone|Given orally (PO).
16050919|NCT02518750|Drug|Panobinostat|Given PO.
16050920|NCT02518750|Drug|Liposomal vincristine|For intravenous (IV) use only.
16050921|NCT02518750|Drug|Mitoxantrone|Given IV.
16050922|NCT02518750|Drug|Peg-asparaginase|"Given IV or intramuscularly (IM).
~In case of allergy or intolerance to Peg-asparaginase, Erwinia L-asparaginase (Erwinase®) will be used. Erwinia L-asparaginase is given by either IV or IM injection."
16050923|NCT02518750|Drug|Bortezomib|Given by IV push over 3 to 5 seconds. For IV use only.
16050924|NCT02518750|Drug|Intrathecal Triples|Given IT as ITMHA.
16050925|NCT02518750|Drug|High-dose methotrexate|Given intrathecally (IT) or IV.
16050926|NCT02518750|Drug|6-Mercaptopurine|Given PO at consistent time each day.
16050927|NCT02518750|Drug|High-dose cytarabine|Given IT or IV.
16050928|NCT02518750|Drug|Nelarabine|Given IV
16050929|NCT02518750|Drug|Cyclophosphamide|Given IV.
16050930|NCT02518750|Drug|Etoposide|"Given IV.
~In case of etoposide reactions, IV etoposide phosphate (Etopophos®) will be used."
16050931|NCT02518750|Drug|Clofarabine|"Given IV.
~Clofarabine will be given instead of nelarabine for patients with B-lymphoblastic leukemia and lymphoma in stratum II."
16050932|NCT02518737|Other|Meal Test|
16050933|NCT02518724|Procedure|RIPC intervention exposure|placing a sphygmomanometer on the non-dominant hand and applying pressure of 200 mmHg for 5 min followed by 5 min without pressure X 4 repeats
16050934|NCT02518724|Procedure|placebo intervention exposure|placing a sphygmomanometer on the non-dominant hand and applying pressure of 100 mmHg for 5 min followed by 5 min without pressure X 4 repeats.
16050935|NCT02518711|Behavioral|Behavioral Teacher Program|This program was based on the evidence-based Summer Treatment Program (MTA Cooperative Group, 1999), involving psycho-education for the teacher and universal and individual behavioral techniques that focused on classroom structure and contingency management
16050936|NCT02518698|Drug|Radium-223 dichloride (Xofigo, BAY88-8223)|Therapies used to treat prostate cancer and more specifically castrate resistant prostate cancer inclusively Xofigo (Radium-223 dichloride, BAY88-8223)
16050937|NCT02518685|Device|TransPyloric Shuttle|
16050938|NCT02518685|Device|Sham procedure|
16050939|NCT02518685|Behavioral|Lifestyle Counseling|The goal of lifestyle modification counseling is to promote adherence to a reduced calorie diet, increased physical activity and to recommend behavioral modification strategies.
16050940|NCT02518672|Dietary Supplement|MAG-DHA|MAG-DHA 8 x 625 mg softgels by mouth, every day at bedtime for 90 days.
16051162|NCT02517216|Device|MRI|
16050941|NCT02518672|Dietary Supplement|Placebo|Placebo (sunflower oil) 8 x 625 mg softgels by mouth, every day at bedtime for 90 days.
16050942|NCT02518659|Dietary Supplement|Inulin|This is the Intervention
16050943|NCT02518633|Device|Continuous positive airway pressure devices|overnight use of CPAP device
16050944|NCT02518620|Biological|ALX-0061|Subjects received ALX-0061 150 mg s.c. injections, beginning at Week 0 and q2w thereafter, up to and including Week 102. Subjects from the preceding study ALX0061-C201 also continued their MTX treatment.
16050945|NCT02518607|Drug|MGB-BP-3|Treatment of CDI
16050946|NCT02518607|Other|Placebo|Placebo
16050947|NCT02518594|Drug|Vaginal progesterone|200mg micronized vaginal progesterone softgel capsule, daily from randomization to < 35 wks
16050948|NCT02518594|Drug|Placebo|placebo softgel capsule, daily from randomization to < 35 wks
16050949|NCT02518594|Device|Arabin Pessary|Placement management from randomization to < 35 wks
16050950|NCT02518581|Procedure|Doubly labelled water method|DLW (doubly labeled water) method measures isotope dilution spaces and elimination rates to assess total energy expenditure (TEE). After enriching the body water of a subject with DLW (2H and 18O), it is only necessary to collect urine samples at defined time points, usually over a period of 1-2 weeks, so that the measurement can be done in individuals able to engage in their typical habits without restrictions. The resulting TEE measurement represents an integral value over the measurement period.
16050951|NCT02518568|Drug|V0355|Oral administration (2 tablets)
16050952|NCT02518555|Biological|Diphtheria Toxoid/Tetanus Toxoid/Acellular Pertussis Vaccine Adsorbed|Given IM
16050953|NCT02518555|Drug|Ibrutinib|Given PO
16050954|NCT02518555|Other|Laboratory Biomarker Analysis|Correlative studies
16050955|NCT02518555|Other|Pharmacological Study|Correlative studies
16050956|NCT02518555|Biological|Pneumococcal 13-valent Conjugate Vaccine|Given IM
16050957|NCT02518555|Other|Quality-of-Life Assessment|Ancillary studies
16050958|NCT02518555|Biological|Trivalent Influenza Vaccine|Given IM
16050959|NCT02518542|Procedure|Endoscopic intervention A|POEM: Per oral endoscopic myotomy
16050960|NCT02518542|Procedure|Endoscopic intervention B|PRD: Prolonged dilatation by temporary implantation of large diameter stent . Stents are additionally attached to the esophageal wall by different technical options.
16050961|NCT02518542|Procedure|Endoscopic intervention C|Endoscopic balloon dilatation
16050962|NCT02518542|Procedure|Laparoscopic Surgery|Laparoscopic Heller myotomy
16050963|NCT02518529|Biological|G17DT|
16050964|NCT02518516|Drug|Rosuvastatin (≥10 mg)|"Current cumulative exposure to high dose rosuvastatin (ATC C10AA07) will be defined as a prescription for ≥10 mg of rosuvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days).
~Past exposure to high dose rosuvastatin (ATC C10AA07) will be defined as a prescription for ≥10 mg of rosuvastatin dispensed >120 days of the index date (i.e. no exposure within 120 days of the index date)."
16050965|NCT02518516|Drug|Atorvastatin (≥20 mg)|"Current cumulative exposure to high dose atorvastatin (ATC C10AA05) will be defined as a prescription for ≥20 mg of atorvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days).
~Past exposure to high dose atorvastatin (ATC C10AA05) will be defined as a prescription for ≥20 mg of atorvastatin dispensed >120 days prior to the index date (i.e. no exposure within 120 days of the index date)."
16050966|NCT02518516|Drug|Simvastatin (≥40 mg)|"Current cumulative exposure to high dose simvastatin (ATC C10AA01) will be defined as a prescription for ≥40 mg simvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days).
~Past exposure to high dose simvastatin (ATC C10AA01) will be defined as a prescription for ≥40 mg simvastatin dispensed >120 days prior to the index date (i.e. no exposure within 120 days of the index date)."
16050967|NCT02518516|Drug|Fluvastatin|"Current cumulative exposure to fluvastatin (ATC C10AA04) will be defined as a prescription for any dose of fluvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days).
~Past exposure to fluvastatin (ATC C10AA04) will be defined as a prescription for any dose of fluvastatin dispensed >120 days prior to the index date (i.e. no exposure within 120 days of the index date)."
16050968|NCT02518516|Drug|Pravastatin|"Current cumulative exposure to pravastatin (ATC C10AA03) will be defined as a prescription for any dose of pravastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days).
~Past exposure to pravastatin will be defined as a prescription for any dose of pravastatin (ATC C10AA03) dispensed >120 days prior to the index date (i.e. no exposure within 120 days of the index date)."
16050969|NCT02518516|Drug|Lovastatin|"Current cumulative exposure to lovastatin (ATC C10AA02) will be defined as a prescription for any dose of lovastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days).
~Past exposure to lovastatin will be defined as a prescription for any dose of lovastatin (ATC C10AA02) dispensed >120 days prior to the index date (i.e. no exposure within 120 days of the index date)."
16050970|NCT02518516|Drug|Atorvastatin (<20mg)|"Current cumulative exposure to low dose atorvastatin (ATC C10AA05) will be defined as a prescription for <20 mg of atorvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days).
~Past exposure to low dose atorvastatin (ATC C10AA05) will be defined as a prescription for <20 mg of atorvastatin dispensed >120 days prior to the index date (i.e. no exposure within 120 days of the index date)."
16050971|NCT02518516|Drug|Simvastatin (<40 mg)|"Current cumulative exposure to low dose simvastatin (ATC C10AA01) will be defined as a prescription for <40 mg simvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-365 days, or 366-730 days).
~Past exposure to low dose simvastatin (ATC C10AA01) will be defined as a prescription for <40 mg simvastatin dispensed >120 days prior to the index date (i.e. no exposure within 120 days of the index date)."
16050972|NCT02518503|Drug|Rosuvastatin (≥10 mg)|Current cumulative exposure to high dose rosuvastatin (ATC C10AA07) will be defined as a prescription for ≥10 mg of rosuvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-<365 days, or 366-730 days).
16051077|NCT02517775|Dietary Supplement|Cranberry deprived supplement|Cranberry deprived supplement Acute intake of 500 mL (1x daily)
16050973|NCT02518503|Drug|Atorvastatin (≥20 mg)|Current cumulative exposure to high dose atorvastatin (ATC C10AA05) will be defined as a prescription for ≥20 mg of atorvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-<365 days, or 366-730 days).
16050974|NCT02518503|Drug|Simvastatin (≥40 mg)|Current cumulative exposure to high dose simvastatin (ATC C10AA01) will be defined as a prescription for ≥40 mg of simvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-<365 days, or 366-730 days).
16050975|NCT02518503|Drug|Fluvastatin|Current cumulative exposure to fluvastatin (ATC C10AA04) will be defined as a prescription for any dose of fluvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-<365 days, or 366-730 days).
16050976|NCT02518503|Drug|Pravastatin|Current cumulative exposure to pravastatin (ATC C10AA03) will be defined as a prescription for any dose of pravastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-<365 days, or 366-730 days).
16050977|NCT02518503|Drug|Lovastatin|Current cumulative exposure to lovastatin (ATC C10AA02) will be defined as a prescription for any dose of lovastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-<365 days, or 366-730 days).
16050978|NCT02518503|Drug|Rosuvastatin (<10mg)|Current cumulative exposure to low dose rosuvastatin (ATC C10AA07) will be defined as a prescription for <10mg of rosuvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-<365 days, or 366-730 days).
16050979|NCT02518503|Drug|Atorvastatin (<20mg)|Current cumulative exposure to low dose atorvastatin (ATC C10AA05) will be defined as a prescription for <20 mg of atorvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-<365 days, or 366-730 days).
16050980|NCT02518503|Drug|Simvastatin (<40 mg)|Current cumulative exposure to low dose simvastatin (ATC C10AA01) will be defined as a prescription for <40 mg simvastatin dispensed prior to the index date in one of the following exposure duration categories (≤120 days, 121-<365 days, or 366-730 days).
16050981|NCT02518490|Device|Sapphire Lens|Each subject will be randomized to wear the test lens on one eye and control lens on one eye.
16050982|NCT02518490|Device|enfilcon A|Each subject will be randomized to wear the test lens on one eye and control lens on one eye.
16050983|NCT02518477|Other|exercise|progressive resistance training
16050984|NCT02518464|Drug|Ticagrelor 90 mg twice per day|Patients will be loaded with 180 mg of Ticagrelor during the enrollment office visit and provided with a 28 day supply of Ticagrelor, 90 mg twice per day. P2Y12 reactivity unit (PRU) testing will be conducted at 7-14 days. If the patient has a positive response, they will have the option of continued access of Ticagrelor 180 mg for another 2 months. Participants will be reminded via text message daily to complete a headache survey on line in order to track their headaches.
16050985|NCT02518451|Drug|Valsartan 160 mg film-coated caplets (test formulation)|In each of the two study periods (separated by a washout of one week) a single dose of test or reference formulation was administered.
16050986|NCT02518451|Drug|Valsartan 160 mg film-coated caplets (reference formulation)|In each of the two study periods (separated by a washout of one week) a single dose of test or reference formulation was administered.
16050987|NCT02518438|Drug|Tramadol|A preprepared 20 ml solution was subcutaneously infiltrated after closure of the uterine incision and the rectus fascia.
16050988|NCT02518412|Other|tDCS|Transcranial Direct Current Stimulation (tDCS) is a non-invasive treatment method, using a low Direct current stimulation to increase excitability and thus stimulate plasticity and cognitive functions.
16050989|NCT02518412|Other|Placebo tDCS|Half of the patients will receive Placebo tDCS. The procedure is the same as for active tDCS, but the in the Placebo tDCS the stimulation is non-active / sham.
16050990|NCT02518399|Other|Heat therapy|Subjects will report to the laboratory 4-5x per week for 8 weeks (36 sessions total) for heat therapy sessions. In each session, subjects will be immersed in a 40°C hot tub for up to 90min in order to increase body core temperature to 38.5°C and, once there, maintain it between 38.5-39.0°C for 60min.
16050991|NCT02518399|Other|Thermoneutral water immersion|Subjects will report to the laboratory 4-5x per week for 8 weeks (36 sessions total) for thermoneutral water immersion sessions. In each session, subjects will be immersed in a 36°C tub for 90min in order to maintain body core temperature at a constant level.
16050992|NCT02518386|Other|No intervention|No intervention is planned
16050993|NCT02518373|Biological|G17DT|G17DT is a therapeutic immunogen, formulated as a white, sterile, semi-viscous, water-in-oil emulsion (30:70 weight for weight). It was manufactured and supplied by Nova Laboratories Ltd., in glass ampoules containing 0.5 mL at a concentration of 1.25 mg/mL, as a single dose to be administered by intramuscular injection.
16050994|NCT02518373|Drug|Omeprazole|Proton pump inhibitor used in the treatment of dyspepsia, peptic ulcer disease, gastroesophageal reflux disease, laryngopharyngeal reflux, and Zollinger-Ellison syndrome.
16050995|NCT02518360|Other|Osteopathic|Body adjustment in three sessions (20 minutes/session).
16050996|NCT02518360|Other|Auto Stretching|The patients realize auto stretching in three sessions (20 minutes/session).
16050997|NCT02518347|Dietary Supplement|FDS-Strawberry|Natural frozen and dried strawberries
16050998|NCT02518347|Dietary Supplement|Placebo|Placebo powder matched for carbohydrates and fiber in the strawberries
16050999|NCT02518334|Other|Alcohol consumption|28 grams (2 drinks) of ethanol will be consumed either in the form of wine or vodka.
16051000|NCT02518321|Device|Technology-Assisted Toileting|
16051001|NCT02518308|Behavioral|Mindfulness-Based Stress Reduction|The Mindfulness-Based Stress Reduction program involves instruction in mindfulness meditation and yoga.
16051002|NCT02518295|Other|Positive control|200ml milk containing 18g lactose
16051003|NCT02518295|Other|Probiotic S. thermophilus|200ml milk containing 18g lactose + probiotic S. thermophilus
16051004|NCT02518295|Other|Probiotic B. longum|200ml milk containing 18g lactose + probiotic B. longum
16051005|NCT02518295|Other|Negative control|200 ml of UHT Lactose free milk
16051006|NCT02518282|Other|Serum levels of high-sensitivity troponin T|Serum levels of hs-cTn will be measured before surgery, upon arrival at the ICU, as well as every 6 hours for 24 hours, then every 8 hours the following 24 hours and a last blood sample will be taken 72 hours after surgery.
16051078|NCT02517762|Behavioral|Physical activity|
16051007|NCT02518282|Other|Twelve-lead ECGs|Twelve-lead ECGs obtained the day prior to heart valvular surgery, immediately upon arrival at the ICU, and then 24, 48 and 72 hours post-surgery will be reviewed by a cardiologist to evidence signs of MI.
16051008|NCT02518282|Other|Transthoracic echocardiography (TTE)|A TTE will be also performed by a cardiologist after cardiac valvular surgery to determine the ejection fraction of left ventricle and the occurrence of a new regional wall motion abnormality. This TTE will be compared, by the same cardiologist, with a TTE performed before cardiac valvular surgery.
16051009|NCT02518269|Procedure|Hip Arthroplasty|Hip Arthroplasty comparing 3 different bearings.
16051010|NCT02518256|Procedure|Lavage of the Cavum uteri and proximal fallopian tubes|
16051011|NCT02518243|Other|Patient's answer with non pharmacological therapeutic|"Installation at patient's home of :
~aromatherapy
~music therapy
~cognitive training in multimedia application offering cognitive games"
16051012|NCT02518230|Device|Neurally Adjusted Ventilatory Assist|The subject will be crossed over from the baseline ventilator mode to Neurally Adjusted Ventilatory Assist
16051013|NCT02518230|Device|Synchronized Interm. Mandatory Assist|The subject will be crossed over from the baseline ventilator mode to Synchronized Intermittent Mandatory Assist with Pressure Support
16051014|NCT02518217|Behavioral|Weight Loss Apps|Provision of commercially available smartphone applications for healthy eating, physical activity, and weight loss.
16051015|NCT02518217|Behavioral|ShapeUp Empower|Online intervention with training in behavioral strategies for healthy eating, physical activity, and weight loss. Includes periodic feedback on weight loss progress and engagement with the intervention platform.
16051016|NCT02518217|Behavioral|Financial Incentives for Engagement|Financial incentives for completing tasks such as viewing instructional information and reporting self-monitored body weights via the study website.
16051017|NCT02518204|Other|BPT|Brain Performance Test (BPT) computerized cognitive assessment battery developed by Lumos Labs, Inc.
16051018|NCT02518204|Other|NP|"Conventional in-person Neuropsychological Assessments (NP)
~Subtests from:
~HRB: Halstead-Reitan Battery
~MATRICS: Measurement and Treatment Research to Improve Cognition in Schizophrenia
~WAIS-IV: Weschler Adult Intelligence Scale - IV"
16051019|NCT02518191|Drug|GnRHa|3.6mg subcutaneous injection every 28 days.Initiated 1-2 weeks before chemotherapy and ended 4-8 weeks after chemotherapy.
16051020|NCT02518178|Device|NFC Necklace|
16051021|NCT02518178|Device|Voice Reminder|Dialect-specific reminders will be issued to the mother's cell phone, informing about the upcoming immunization camp and the importance of vaccination
16051022|NCT02518178|Device|NFC Sticker|NFC Sticker on existing immunization card (MAMTA card) serves as a comparator to the pendant and pendant+voice call arms.
16051023|NCT02518165|Dietary Supplement|Proprietary spearmint extract|Water extracted spearmint extract
16051024|NCT02518165|Other|Placebo|Microcrystalline Cellulose
16051025|NCT02518152|Procedure|Open flap debridement (OFD)|Oral prophylaxis followed by Open flap debridement (OFD)
16051026|NCT02518152|Procedure|OFD with Platelet rich fibrin (PRF)|Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into the bone defect
16051027|NCT02518152|Procedure|OFD with Platelet rich fibrin (PRF)+1% Alendronate|Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF)+1% Alendronate placement into the bone defect
16051028|NCT02518139|Drug|TD-4208|Subjects receiving TD-4208 are blinded to one of two doses of 4208.
16051029|NCT02518139|Drug|Tiotropium|There is not a placebo, there is an active comparator (Tiotropium) arm.
16051030|NCT02518126|Other|blood sample and tissue sample|After birth and fetal umbilical cord disconnection, a blood sample will be taken from the umbilical cord (cord blood) of IUGR and of AGA fetuses (5cc) for cytokine ELISA testing. Also a small sample of the placenta will be examined in order to assess the level of ACTH protein in IUGR and AGA embryos
16051031|NCT02518113|Drug|LY3039478|Administered orally
16051032|NCT02518113|Drug|Dexamethasone|Administered orally
16051033|NCT02518113|Drug|Placebo|Administered orally
16051034|NCT02518100|Device|Vital Signs Patch (VSP) System 3-Lead (NEHB) Configuration|Vital signs will be taken using the Vital Signs Patch (VSP) System 3-Lead (NEHB) Configuration on each study participant in each Arm of this study for comparison against the same vital signs taken with traditional methods used by the facility.
16051035|NCT02518100|Device|Vital Signs Patch (VSP) System 1-Lead (PAL) Configuration|Vital signs will be taken using the Vital Signs Patch (VSP) System 1-Lead (PAL) Configuration on each study participant in each Arm of this study for comparison against the same vital signs taken with traditional methods used by the facility.
16051036|NCT02518087|Device|oXiris®|"oXiris® membrane set is composed of a 1.5 m2 copolymer of acrylonitrile and sodium methylsulfonate (AN 69) with polyethylenimine treated surface and adhered heparin during set´s fabrication [oXiris® (Baxter Gambro)].
~Blood flow between 200-250 mL/min will be derivatised from the CPB circuit (arterial positive pressure line just after the oxygenator) into the PrismafleX eXeed™, so that it all flows thru the oXiris® membrane and returned to the CPB circuit into the venous reservoir just before the oxygenator. oXiris® membrane will be only employed for adsorption (neither convection nor diffusion will be performed) during all CPB time."
16051037|NCT02518074|Other|Hearing and Vestibular Interactions|in two body positions (standing / supine) and three gravity conditions (weightlessness hyper gravity and normal gravity).
16051038|NCT02518061|Other|No intervention|This is a retrospective study
16051039|NCT02518048|Drug|LEO 90100 Aerosol foam|
16051040|NCT02518048|Drug|Betesil® 2.25 mg|
16051041|NCT02518035|Drug|Silicone Gel|Silicone gel will be applied twice per day in the experimental group
16051042|NCT02518022|Drug|Insulin|Insulin for beer
16051043|NCT02518009|Other|Genetic men treated with estrogen|Observational during estrogen treatment
16051044|NCT02518009|Other|Genetic women treated with androgen|Observational during androgen treatment
16051079|NCT02517749|Device|Chest Drain Insertion and Talc Pleurodesis|
16051080|NCT02517749|Device|Indwelling Pleural Catheter Insertion and Talc Pleurodesis|
16051081|NCT02517736|Drug|Sorafenib at a dose of 800 mg / day|
16051163|NCT02517190|Other|Parabolic flight|
16051164|NCT02517190|Other|neuro-endocrine measurements|psychic stress tests, stress hormones: prolactin, cortisol, endo-cannabinoids
16051045|NCT02517996|Drug|Lidocaine|Total 20cc (10cc bilateral) of 1% Lidocaine: Lidocaine is a commonly used anesthetic agent suitable for infiltration, block and surface anesthesia. It is characterized by a rapid onset of action, intermediate duration of efficacy, and its elimination half-life is 90-120 minutes. Lidocaine alters signal conduction in neurons by blocking the fast voltage gated sodium (Na) channels in the neuronal cell membrane that are responsible for signal propagation. With sufficient blockage the membrane of the postsynaptic neuron will not depolarize and will thus fail to transmit an action potential. This creates the anesthetic effect by not merely preventing pain signals from propagating to the brain but by stopping them before they begin. Adverse drug reactions are rare when lidocaine is used as a local anesthetic and when administered correctly.
16051046|NCT02517996|Drug|Placebo|Patients randomized in this arm will receive preemptive bilateral pudendal nerve block with 20 cubic centimeters normal saline after anesthesia induction.
16051047|NCT02517983|Other|epidemiology|Relative prevalence of different chronic respiratory disease phenotypes
16051048|NCT02517970|Behavioral|Technology distraction|Infants will be fed with classical music playing in the background for one feeding and with a television show playing for the mother to watch during the other.
16051049|NCT02517957|Drug|Furoic acid loperamide hydrochloride cream|Apply to lesion area without erosion, drainage, 1 times a day, continuous use 1 week after according to disease reduction or withdrawal, the longest do not exceed 4 weeks. Pure dry area or no skin itching area should not be applied.
16051050|NCT02517957|Drug|Mullite ointment|Applies to a blister, pustule, erosion, ulcer, leaking or comorbid folliculitis, in skin lesions of 2 times a day, 5 days for one period of treatment, but for two consecutive period of treatment
16051051|NCT02517957|Drug|3% boric acid solution|3% boric acid solution is suitable for the erosion seepage skin, can open intermittent shi fu, 5-10 min each time, 2 times daily or several times.
16051052|NCT02517957|Drug|Zine oxide|In wet apply the break to zinc oxide preparation for external use only, when erosion seepage control is disabled in skin lesions.
16051053|NCT02517931|Procedure|Sphenopalatine Ganglion Block|Subjects will be asked to blow out each nostril. They will then be laid supine with a small shoulder roll and intranasal phenylephrine 0.25% (RhinallⓇ) will be sprayed once into each nostril to preemptively minimize bleeding. SPGB will be performed by inserting long cotton tipped applicators saturated in 2% viscous lidocaine into nostril until properly seated in the posterior nasopharynx. These will be left in place for 10 minutes and then 1mL of 0.5% bupivacaine will be administered down the plastic hollow shaft of each applicator via an 18g angiocatheter. The applicators will remain in place for 10 more minutes and then be removed.
16051054|NCT02517931|Procedure|Placebo|Subjects will be asked to blow out each nostril. They will then be laid supine with a small shoulder roll and intranasal phenylephrine 0.25% (RhinallⓇ) will be sprayed once into each nostril to preemptively minimize bleeding. SPGB will be performed by inserting long cotton tipped applicators saturated in carboxymethylcellulose based lubricant (i.e. K-Y Jelly®) into nostril until properly seated in the posterior nasopharynx. These will be left in place for 10 minutes and then 1 mililiter of normal saline will be administered down the plastic hollow shaft of each applicator via an 18g angiocatheter. The applicators will remain in place for 10 more minutes and then be removed.
16051055|NCT02517918|Drug|Sirolimus combined with CP, MT and ZA|"Cyclophosphamide, Methotrexate and Sirolimus will be administrated orally. Zoledronic Acid will be administrated by infusion (IV).
~Trial based on a dose escalating study design assessing two dose levels of sirolimus when prescribed in combination with metronomic cyclophosphamide (CP), methotrexate (MT) and zoledronic acid (ZA) followed by an expansion cohort once the MTD is established."
16051056|NCT02517905|Drug|Bupivacaine liposome|Local administration
16051057|NCT02517905|Drug|Placebo|Local administration
16051058|NCT02517892|Procedure|Biopsy|
16051059|NCT02517879|Other|Community point distribution|Households were invited to a central location in their community (i.e. school, church, etc) where they received their allotment of ITNs (one per sleeping space, as pre-registered ahead of study activities). Households were provided with malaria prevention messaging at the distribution. They were called up one-by-one in front of other members of the community to mitigate misrepresentation of households.
16051060|NCT02517879|Other|Community health worker hang-up visit|CHWs visited households to take stock of how many ITNs that were distributed during the distribution were hung and to hang any unhung ITNs.
16051061|NCT02517866|Drug|Azilsartan Medoxomil|Azilsartan medoxomil tablets
16051062|NCT02517853|Device|Posterior tibial nerve stimulation|
16051063|NCT02517853|Device|Sham posterior tibial nerve stimulation|
16051064|NCT02517827|Device|Atherectomy and paclitaxel-coated balloon angioplasty|Directional atherectomy and paclitaxel-coated balloon angioplasty (optional with stentimplantation) of the common femoral artery
16051065|NCT02517827|Procedure|Open, surgical endarterectomy|open, surgical endarterectomy of the common femoral artery
16051066|NCT02517814|Dietary Supplement|Vitamin D|
16051067|NCT02517801|Dietary Supplement|Anthocyanin capsules|Chronic intake of 2 capsules for 30 days (2x daily). Capsules with 80 mg of anthocyanins.
16051068|NCT02517801|Dietary Supplement|placebo capsules|Chronic intake of 2 capsules for 30 days (2x daily). 2 capsules devoid of anthocyanins.
16051069|NCT02517788|Drug|Interferon beta-1a HSA-free biosimilar|6 MIU/0.53 mL in pre-filled glass syringe solubilized in aqueous isotonic buffered solution without albumin
16051070|NCT02517788|Drug|Interferon beta-1a HSA+ biosimilar|6 MIU/0.53 mL in pre-filled glass syringe solubilized in aqueous isotonic buffered solution combined with albumin solution
16051071|NCT02517788|Drug|Interferon beta-1a original|6 MIU/0.50 mL in pre-filled glass syringe solubilized in HSA and mannitol solution (marketed formulation)
16051072|NCT02517775|Dietary Supplement|Cranberry 320|Dietary Supplement: Cranberry beverage with 320 mg of (poly)phenols Acute intake of 500 mL (1x daily)
16051073|NCT02517775|Dietary Supplement|Cranberry 640|Dietary Supplement: Cranberry beverage with 640 mg of (poly)phenols Acute intake of 500 mL (1x daily)
16051074|NCT02517775|Dietary Supplement|Cranberry 960|Dietary Supplement: Cranberry beverage with 960 mg of (poly)phenols Acute intake of 500 mL (1x daily)
16051075|NCT02517775|Dietary Supplement|Cranberry 1280|Dietary Supplement: Cranberry beverage with 1280 mg of (poly)phenols Acute intake of 500 mL (1x daily)
16051076|NCT02517775|Dietary Supplement|Cranberry 1600|Dietary Supplement: Cranberry beverage with 1600 mg of (poly)phenols Acute intake of 500 mL (1x daily)
16051082|NCT02517723|Behavioral|Narrative Exposure Therapy|"Narrative Exposure Therapy (NET) is based on Testimony Therapy in combination with cognitive behavioural exposure techniques and elements of client-centered counselling. The clients can restore their autobiographic memories about their traumatic experiences. In this way fragmentary memories are transformed into a coherent narrative structure. This practice enables the processing of painful emotions and the construction of clear contingencies of dangerous and safe conditions, generally leading to significant emotional recovery. Therapeutic aims are the reduction of PTSD-Symptomload via activation of fear-network and habituation of fear and the placement of traumatic experiences in a reconstructed, detailed and consistent autobiography.
~NET will be applied in eight sessions (90-120min/session) in a standardized, manualized manner."
16051083|NCT02517723|Behavioral|Dialectical Behavior Therapy|"Dialectical behavior therapy is a cognitive behavioral treatment program developed by Marsha Linehan to treat suicidal clients meeting criteria for BPD. It directly targets suicidal behavior, behaviors that interfere with treatment delivery, and other dangerous, severe, or destabilizing behaviors.
~Via standard DBT patients improve behavioral capabilities, motivation for skillful behavior, generalization of gains to the natural environment, structuring the treatment environment so that it reinforces functional rather than dysfunctional behaviors. It also targets the therapist capabilities and motivation to treat patients effectively. Patients get weekly individual psychotherapy (1 h/wk), group skills training (3.75 h/wk), a weekly therapist consultation team meetings."
16051084|NCT02517723|Behavioral|Standard Inpatient Care|Unspecific group therapy that is identical in both groups (music therapy etc.)
16051085|NCT02517723|Other|Waiting List|Treatment as usual in the community (no DBT, no exposure of trauma memories)
16051086|NCT02517710|Procedure|Stratafix synthetic barbed suture|hysterotomy closure in Cesarian section
16051087|NCT02517697|Drug|14 Nitrogen (N) Sodium Nitrite|oral formulation of sodium nitrite 40 mg three times daily for 12 weeks
16051088|NCT02517697|Drug|Placebo|oral formulation of matching placebo three times daily for 12 weeks
16051089|NCT02517684|Drug|Infliximab|
16051090|NCT02517684|Drug|Prednisolone|
16051091|NCT02517684|Other|Exclusive enteral nutrition|
16051092|NCT02517684|Drug|Azathioprine|
16051093|NCT02517671|Device|Enhanced External Counterpulsation (EECP)|EECP is a non-invasive therapy that has been approved by the United States Food and Drug Administration (FDA) for the management of refractory angina and heart failure. This study is using the device to potentially improve 1.5 mile run times and VO2max in healthy volunteers.
16051094|NCT02517658|Other|Video|Watching a YouTube video containing post tonsillectomy discharge instructions.
16051095|NCT02517658|Other|Standard discharge teaching|Receiving standard post tonsillectomy discharge instructions from the nurse prior to discharge.
16051096|NCT02517632|Behavioral|Exercise, nutritional and pharmaceutical counceling|The exercise group will be submitted to a physical exercise intervention protocol performed three times per week, 60 minutes per session, during 6-month period, and a monthly counseling from pharmaceutical and nutritional professionals provided during the follow-up and consisted on general guidance about healthy eating habits for patients with heart failure, mainly sodium and water intake, and medication usage, particularly drug dosage and compliance.
16051097|NCT02517632|Behavioral|Nutritional and pharmaceutical counceling|The control group will be submitted to a monthly counseling from pharmaceutical and nutritional professionals provided during the follow-up and consisted on general guidance about healthy eating habits for patients with heart failure, mainly sodium and water intake, and medication usage, particularly drug dosage and compliance.
16051098|NCT02517619|Drug|Dexamethasone Phosphate Ophthalmic Solution|40 mg/mL
16051099|NCT02517619|Drug|Prednisolone Acetate Ophthalmic (1%)|Prednisolone Acetate (1%)
16051100|NCT02517606|Other|Conventional physical therapy plus HPCS|Conventional physical therapy plus the addition of hip posterolateral complex strengthening
16051101|NCT02517606|Other|Conventional physical therapy|Conventional physical therapy (combination of manual therapy techniques and exercises for spinal segmental stabilization)
16051102|NCT02517593|Genetic|Polygenic Risk Score|A Polygenic Risk Score (PRS) is a blood based genetic test which assesses 77 common breast cancer susceptibility loci (Single Nucleotide Polymorphisms). The PRS has been retrospectively validated and categorizes women into three categories of lifetime risk of developing breast cancer: Low Risk (<15% lifetime risk), Above Average Risk (15 to 40%), and high risk (>40%).
16051103|NCT02517580|Dietary Supplement|Vitamin K2 (MK7)|
16051104|NCT02517567|Device|Delefilcon A contact lenses|Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
16051105|NCT02517567|Device|Narafilcon A contact lenses|Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
16051106|NCT02517567|Device|Somofilcon A contact lenses|Daily disposable, silicone hydrogel contact lenses used according to manufacturer's instructions
16051107|NCT02517554|Behavioral|Penn genetic counselors provides counseling and test results disclosure by videoconferene to patient at community site|Baseline and follow up survey
16051108|NCT02517554|Behavioral|Penn genetic counselor provides counseling and test results disclosure by telephone to patient at community site|Baseline and follow up surveys
16051109|NCT02517554|Behavioral|Patient receives written information on how to find genetic services in their area|Baseline and follow up surveys
16051110|NCT02517541|Device|SenSura Mio Convex Soft|SenSura Mio Convex Soft is a CE marked ostomy product manufactured by Coloplast
16051111|NCT02517528|Drug|ABT-450/r/ABT-267|Tablet
16051112|NCT02517528|Drug|ABT-333|Tablet
16051113|NCT02517528|Drug|ribavirin|Tablet
16051114|NCT02517515|Drug|ombitasvir/paritaprevir/ritonavir and dasabuvir|Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet
16051115|NCT02517515|Drug|Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir|Placebo for ombitasvir/paritaprevir/ritonavir and dasabuvir
16051116|NCT02517502|Drug|DHA|4 capsules of 400 mg DHA daily
16051117|NCT02517502|Drug|Placebo|Matched, blinded placebo
16051118|NCT02517489|Drug|Hydrocortisone|Hydrocortisone will be given in a double-blind fashion for 8 or 14 full days. The intravenous route will be used. The treatment course will include 4 or 7 days of full dose (200 mg/day by continuous infusion), 2 or 4 days of half dose (100 mg/day by continuous infusion), and 2 or 3 days of tapering dose (50 mg/day by continuous infusion). Duration of treatment is chosen upon patient initial improvement.
16051119|NCT02517489|Drug|Placebo|Placebo will be given in a double-blind fashion for 8 or 14 full days. The intravenous route will be used. The treatment course will include 4 or 7 days of full dose (200 mg/day by continuous infusion), 2 or 4 days of half dose (100 mg/day by continuous infusion), and 2 or 3 days of tapering dose (50 mg/day by continuous infusion). Duration of treatment is chosen upon patient initial improvement.
16051120|NCT02517476|Dietary Supplement|Nutritional therapy|Any nutritional product and route (i.e. food fortification, oral, enteral, parenteral) is possible to reach goals
16051121|NCT02517463|Drug|Ulipristal acetate|This is an observational study on subjects taking a single intervention, i.e. ulipristal acetate for emergency contraception. The intervention is not randomised nor assigned by the investigator.
16051122|NCT02517450|Behavioral|an adventure-based training programme|The programme consisted of five education sessions (around 75 minutes each) and a day's adventure-based training camp at the end of the academic year
16051123|NCT02517450|Other|a placebo control programme|Subjects in the control group were invited to attend five 75-minute sessions of leisure activities, organised by a community centre, which included a cartoon film show, handicraft workshops, a health talk on the prevention of influenza and age-appropriate physical leisure activities, such as table tennis, badminton, chess and Chinese billiards. Additionally, they were invited to join a day visit to Hong Kong Ocean Park at the end of the academic year.
16051124|NCT02517437|Drug|Suprascapular & axillary blocks|After infiltration with 1 mL of 1% lidocaine, local anesthetics (20 mL of 0.5% ropivacaine) will then be injected in 5 mL aliquots to achieve circumferential spread around the nerve.The axillary nerve block will be performed next in the posterior aspect of the operative arm. The neurovascular bundle encompassing the humeral artery, posterior circumflex artery, and axillary nerve is visualized in the lateral edge of the quadrangular space, deep to the deltoid muscle, inferior to the teres minor muscle, and superior to the triceps tendon. After infiltration with 1 mL of 1% lidocaine, local anesthetics (20 mL of 0.5% ropivacaine) will then be injected in 5 mL aliquots after negative aspiration to achieve circumferential spread around the bundle.
16051125|NCT02517437|Drug|Interscalene block|After sterile skin preparation with chlorhexidine and infiltration with 1 mL of 1% lidocaine, a 5 cm 22 G insulated needle is then inserted and local anesthetic solution (20 mL of 0.5% ropivacaine) will be injected in 5 mL aliquots after negative aspiration for blood to achieve spread posterior to or between the C5 and C6 nerve roots.
16051126|NCT02517424|Drug|High THC/Low CBD Cannabis|Dried cannabis
16051127|NCT02517424|Drug|High THC/High CBD Cannabis|Dried cannabis
16051128|NCT02517424|Drug|Low THC/Low CBD Cannabis|Dried cannabis
16051129|NCT02517411|Other|Standard care|The standard care of stable COPD is based on long-acting bronchodilators (LABD).
16051130|NCT02517411|Other|Physiotherapy added to standard care|The treatment will be based on domiciliary physiotherapy program during 8 weeks, twice a week added to standard care. The duration of the sessions will be 45-60 minutes. The physiotherapy treatment includes: breathing exercises, electrostimulation in quadriceps with voluntary contraction and exercises with theraband. This will be a home-based program supervised by a physiotherapist.
16051131|NCT02517398|Drug|MSB0011359C|Subjects will receive intravenous infusion of MSB0011359C once every 2 weeks in a dose escalation fashion until confirmed progression, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product (IMP) occurs.
16051132|NCT02517385|Drug|Phosphatidylcholine|Pharmaceutical form:Paste Route of administration: Oral
16051133|NCT02517372|Drug|CRD007|
16051134|NCT02517359|Drug|RV6153 single dose|Safety and tolerability of single doses
16051135|NCT02517359|Drug|RV6153 matching placebo single dose|Safety and tolerability of single doses
16051136|NCT02517359|Drug|RV6153 14 day repeat dose|Safety and tolerability of repeat doses
16051137|NCT02517359|Drug|RV6153 matching placebo 14 day repeat dose|Safety and tolerability of repeat doses
16051138|NCT02517359|Drug|RV6153 28 day repeat dose|Safety and tolerability of repeat doses
16051139|NCT02517359|Drug|RV6153 matching placebo 28 day repeat dose|Safety and tolerability of repeat doses
16051140|NCT02517346|Other|Standard follow-up|Standard management according to Spanish Respiratory Society guidelines in Sleep Unit.
16051141|NCT02517346|Other|Telemonitoring|Follow up by telemonitoring system during 3 months
16051142|NCT02517333|Other|EPIC Club|Weekly exercise gym sessions (1-2 times weekly) for 45-60 mins each session. Participants will start with a warm-up of 30 mins cardiovascular training either doing cycling, treadmill running or cross-training. The remainder of the session consists of strength/resistance and weight-training involving leg press, leg extensor, pull downs, kettle bells, dumbbells. Gym sessions aim to involve bursts of high-intensity and monitoring of heart rate (potentially with wrist activity monitors with heart rate monitoring and accelerometers) to identify level of physical activity intensity. Participants will also have the opportunity to engage in 'Have a go' sports days run by the Oxfordshire Sports Partnership.
16051143|NCT02517320|Drug|MT-3995 Low|
16051144|NCT02517320|Drug|MT-3995 Middle|
16051145|NCT02517320|Drug|MT-3995 High|
16051146|NCT02517320|Drug|Placebo|
16051147|NCT02517307|Drug|Intralipid/Heparin|Co-infusion of intralipid and heparin solutions during a hyperinsulinemic euglycemic clamp
16051148|NCT02517307|Drug|Glycerol/Saline|Co-infusion of a glycerol/saline solutions during a hyperinsulinemic euglycemic clamp
16051149|NCT02517307|Drug|Hyperinsulinemic euglycemic clamp|Infusion of insulin at at 40 mU/m2/min for 5 hours. Blood glucose will be monitored every 5 min during the insulin infusion and euglycemia will be maintained throughout the clamp by infusing 20% dextrose at a variable rate.
16051150|NCT02517294|Device|Parker flex-tip nasotracheal tube|specially designed nasotracheal tube used for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size
16051151|NCT02517294|Device|Standard nasotracheal tube|standard nasotracheal tube for nasotracheal intubation assess nasopharynx for severity of bleeding grade adenoid size
16051152|NCT02517281|Procedure|Biopsy|
16051153|NCT02517268|Procedure|Pancreaticoduodenectomy|
16051154|NCT02517255|Device|Cardiac Magnetic Resonance Imaging|7 day-Cardiac MRI: T1 and T2 images; 3 and 6 month-Cardiac MRI: T1, T2 and stress perfusion images
16051155|NCT02517242|Device|Pens Device|
16051156|NCT02517242|Device|Syringe|
16051157|NCT02517242|Other|Monitoring capillary blood glucose with blood glucose monitor, lancet tapes and capillary blood glucose tests (3 tests/day)|
16051165|NCT02517190|Other|immunological measurements|blood cell counts, B2 integrins, cytokines, C-reactive protein
16051166|NCT02517190|Other|cellular energy metabolism measurements|purines, lactate
16051167|NCT02517177|Other|Parabolic flight|
16051168|NCT02517177|Other|Cardiovascular parameters measurements|
16051169|NCT02517164|Other|Measurement of serum 25-hydroxyvitamin D|
16051170|NCT02517164|Other|"Analysis of global cognitive efficiency score assessed by the Montreal Cognitive Assessment (MoCA)."|
16051171|NCT02517151|Drug|Ferric carboxymaltose|
16051172|NCT02517151|Drug|Placebo|
16051173|NCT02517138|Other|Parabolic flight|
16051174|NCT02517138|Other|Measurements of eye movements and perception|
16051175|NCT02517125|Device|Transoral robotic-assisted surgery with Da Vinci Xi|
16051176|NCT02517112|Other|Parabolic flight|
16051177|NCT02517112|Other|Cardiovascular parameters measurements|with Ballistocardiography (BCG), electric cardiography (ECG), impedance cardiography (ICG) and echocardiography
16051178|NCT02517112|Device|3D-BCG sensor|
16051179|NCT02517099|Drug|Beclometasone|Beclometasone dipropionate 200mcg bd for 4 months
16051180|NCT02517099|Drug|Co-amoxiclav|Co-amoxiclav 0.3ml/kg bd for 4 weeks
16051181|NCT02517099|Drug|Azithromycin|Azithromycin 10mg/kg od for 4 weeks
16051182|NCT02517086|Other|therapeutic exercises|The applied therapeutic exercises involve shoulder movements including flexion, extension, abduction, adduction, internal and external rotation in isolated or combined movements, with ten repetitions of each movement, associated with the music, and stretching movements finalizing the sequence of movements.
16051183|NCT02517086|Other|elastic compression|exercises for upper limb will be performed for an hour associated with the use of elastic compression. Elastic compression will be effected through a clamp brand compression of 30-40 mmHg according to the measures of voluntary member.
16051184|NCT02517086|Other|functional compressive bandaging|exercises for upper limb will be performed for an hour associated with the use of functional compressive bandaging. The functional compressive bandaging will be held with the volunteer sitting with ipsilateral upper limb resting on the support surgery. After hydration member a cotton mesh is used to prevent friction density 1cm strip of foam on the member to be wrapped. Elastic bandages of cotton will be involved 5 cm, 10 cm, 15 cm from the fingers to the axillary region multilayered
16051185|NCT02517047|Device|CareTRx|CareTRx is a novel device that can be applied to most MDI (meter dose inhaler) device and leverages mobile and cloud computing to objectively assess and provide real-visualize feedback to patients and providers around medication adherence and disease control in pediatric asthma.
16051186|NCT02517034|Other|Comprehensive Geriatric Assessment|Follow geriatric assessment-driven treatment plan
16051187|NCT02517034|Other|Quality-of-Life Assessment|Ancillary studies
16051188|NCT02517034|Other|Questionnaire Administration|Ancillary studies
16051189|NCT02517034|Other|Survey Administration|Ancillary studies
16051190|NCT02517021|Drug|Pro-netupitant/Palonosetron|
16051191|NCT02517021|Drug|Netupitant/Palonosetron|
16051192|NCT02517021|Drug|Dexamethasone|
16051193|NCT02517008|Other|Mama kit|A low-cost non-monetary incentive (mama kit) was provided to all women who delivered at the facility between June 1, 2013 - Aug 31, 2013. Women were told about the intervention during ANC, and safe motherhood groups in the community promoted the intervention in the catchment areas of the treatment facilities.
16051194|NCT02516995|Device|Functional magnetic resonance imaging|
16051195|NCT02516995|Device|Ultrasound|
16051196|NCT02516982|Other|Whooley Questions|The Whooley questions are a case-finding instrument for depression in primary care. This 2-question instrument screens for depressed mood and anhedonia that have been present during the past month. Respondents are required to answer Yes or No to each of these questions. An affirmative answer to any of them should be followed by further assessment, including the use of a validated screening instrument or referral to a general practitioner or a mental health practitioner.
16051197|NCT02516982|Other|Edinburgh Postnatal Depression Scale|The Edinburgh Postnatal Depression Scale (EPDS) is a 10-item self-administered survey that screens for symptoms such as feelings of guilt, sleep disturbance, reduced energy levels, anhedonia and suicidal ideation that have been present during the 7 days preceding its administration. Each question is scored on a 4-point scale ranging from 0 to 3 points. Overall scores between 10 and 12 points suggest increased risk for depression; scores of 13 points or above indicate that the diagnostic criteria for major depression disorder have probably been met. In addition, item 10 deals with suicidal thoughts. The EPDS is a valid and reliable tool for identifying women at risk of depression, both during pregnancy and postpartum, and is sensitive to changes in the severity of depression over time.
16051198|NCT02516982|Other|Momentary questions|These will consist of 5 questions on a 5-point pictorial scales, assessing participants' mood, sleep, energy, enjoyment and worry.
16051199|NCT02516982|Other|Contextual questions|Two questions asking for participants' location and activity at the time they were asked to complete the momentary questions.
16051200|NCT02516969|Radiation|Stereotactic Body Radiotherapy|Radiation
16051201|NCT02516956|Other|Breakfast consumption|Participants will consume the assigned breakfast each morning for 7 days. Participants will express a hedonic rating of the breakfast through 7-point Likert Scales before (overview) and after breakfast consumption.
16051202|NCT02516956|Other|Blood tests|On the third day, participants will be involved in blood tests. Blood will be taken at baseline (fasting), and up to 4 hours after consuming the breakfast. Participants will complete serial visual analog rating scales of hunger and fullness before (fasting) and every 30 minutes up to 4 hours after breakfast consumption.
16051203|NCT02516956|Other|Food choices and energy intakes assessments|Following the last blood sample, participants will be given the opportunity to consume food ad libitum from a buffet lunch. Double weighing of food will be set up to evaluate food choices and energy intake of lunch. During the test week, participants will record all foods and beverage on a 7-day food dairy.
16051204|NCT02516956|Other|Attention tests|On the fourth day, 4 hours after the breakfast consumption and avoid other foods, participants will be involved in attentional test (Mackworth Clock Test for sustained attention and Stroop Test for selective attention).
16051294|NCT02516423|Drug|lenalidomide|oral
16051295|NCT02516423|Drug|dexamethasone|oral
16051296|NCT02516423|Drug|zoledronic acid|IV
16051205|NCT02516956|Other|fRMI tests|On the fifth day, 4 hours after the breakfast consumption and avoid other foods, participants will focus on a set of photographs (stimuli will be randomly choose from three categories of pictures including food, nonfood, and blurred baseline images) during an fMRI brain scan procedure to scan brain activation responses
16051206|NCT02516943|Other|Control|The patient's ABGs were test according to a 4 - hour routine
16051207|NCT02516943|Other|Guideline|The patient's ABGs were test according to the guideline for requests Arterial Blood Gas status post cardiac surgery
16051208|NCT02516930|Behavioral|crowdsourced video|video promoting condom use
16051209|NCT02516930|Behavioral|social marketing video|
16051210|NCT02516917|Behavioral|Attention Training Technique|
16051211|NCT02516904|Drug|CD101 IV|antifungal
16051212|NCT02516904|Drug|Placebo|normal saline
16051213|NCT02516891|Device|Drug-Eluting Stents implantation in bifurcation lesions|
16051214|NCT02516878|Procedure|Acupuncture|"Eight body acupuncture points will be chosen as Tianshu(ST-25), Daheng(SP-15), Daimai(GB-26), Qihai(CV-6), Zhongwan(CV-12), Zusanli(ST-36), Fenlong(ST-40), Sanyinjiao(SP-6). The needles will be retained for 30 minutes.
~Participants of the treatment group will additionally receive unilateral auricular acupressure at four auricular points as Hunger, Shen men, Spleen and Stomach with Semen Vaccariae embedded within adhesive tape in each treatment session. Acupressure will be applied by the subjects with repeat pressing of the tape with fingertips for 3 minutes per point, 3 times per day. The embedded tape will be retained in-situ until the next visit and then the alternate side of ear will be treated."
16051215|NCT02516865|Device|Fitbit activity tracker|Tracks steps taken, floors climbed, and distance traveled. Sleep quality is an additional measurement.
16051216|NCT02516865|Device|Ankle weights|Worn during typical daily activities.
16051217|NCT02516852|Other|Egg production|Establishment and support of a community-owned and -operated egg production facility located at a central location in the community
16051218|NCT02516839|Behavioral|Regulation of Cues (ROC)|Participants are provided information about basic learning theory and how physiological responses to food cues develop and can be managed. Lack of sensitivity to appetite and satiety cues and increased sensitivity to food cues will be discussed. Coping skills are presented to assist in mastery and toleration of food cue sensitivity. Participants will complete experiential learning exercises with food, and taught to monitor their hunger,satiety, and cravings. The physical activity program will focus on increasing both lifestyle activity and structured exercise programs.
16051219|NCT02516839|Behavioral|Behavioral Weight Loss (BWL)|All participants will be instructed on how to consume a balanced deficit diet of conventional foods; individual goals for energy intake will be based on initial body weight. Participants will be instructed in measuring portion sizes, counting calories (with a calorie counter provided or on their phone), and self-monitoring food intake. The physical activity program will focus on increasing both lifestyle activity and structured exercise programs. Behavior change recommendations include stimulus control, self-monitoring, goal setting, managing high-risk situations, meal planning, slowing eating, problem solving, social support, cognitive restructuring, lapse and relapse prevention skills, and maintaining weight loss.
16051220|NCT02516839|Behavioral|BWL + ROC|BWL and ROC will be integrated for this arm, to capitalize on the strengths of both treatments. All participants will be taught to decrease caloric intake and increase physical activity, and to use all of the behavioral skills provided in BWL. However, they will also be taught models of hunger and satiety and about food cue reactivity, and will learn skills to manage these. This arm will include an experiential component, including hunger monitoring during dinner and participating in exposure sessions in the clinic.
16051221|NCT02516839|Behavioral|Nutrition Education, Stress Management and Social Support|Topics included will be stress management/relaxation, social support, and nutrition education. There will be a strong mindfulness component to this group.
16051222|NCT02516826|Drug|Rosuvastatin|
16051223|NCT02516826|Drug|Olmesartan|
16051224|NCT02516826|Drug|Combination|Rosuvastatin/Olmesartan(Combination)
16051225|NCT02516826|Drug|Placebo of Rosuvastatin|
16051226|NCT02516826|Drug|Placebo of Olmesartan|
16051227|NCT02516826|Drug|Placebo of Rosuvastatin/Olmesartan(Combination)|
16051228|NCT02516813|Drug|MSC2490484A (M3814)|Phase Ia: Subjects will receive a starting dose of 100 milligram (mg) or 50 mg of MSC2490484A as Capsule or tablet orally once daily 1.5 hours prior each RT.
16051229|NCT02516813|Radiation|Fractionated RT|Phase Ia: Subjects will receive fractionated palliative RT (3 Gray [Gy] * 10 in Arm A and 2 Gy * 33 to 35, 5 fractions per week [F/W]) in Arm B.
16051230|NCT02516813|Drug|Cisplatin|Cisplatin will be given twice at a dose of 100 milligram per square meter (mg/m^2) or weekly at a dose of 40 (mg/m^2).
16051231|NCT02516813|Drug|MSC2490484A (M3814)|Phase Ib: Subjects will receive the assigned dose of MSC2490484A once daily orally.
16051232|NCT02516813|Drug|MSC2490484A (M3814)|Ancillary cPoP Study: Subjects will receive a single oral MSC2490484A capsule on Day 2, 1.5 hours before the start of RT.
16051233|NCT02516813|Radiation|Fractionated RT|Phase Ib: Subjects will receive fractionated RT (2 Gy x 33, 5 F/W).
16051234|NCT02516813|Radiation|Fractionated RT|Ancillary cPoP study: Subjects will receive a single high dose of RT (10-25 Gy) capsule on Day 1 given on Lesion 1 and a single high dose of RT (10-25 Gy) on Day 2 given on Lesion 2.
16051235|NCT02516787|Other|Parabolic flight|
16051236|NCT02516787|Other|EEG measurement|Electro cortical power in alpha frequency ranges (EEG-LORETA)
16051237|NCT02516787|Other|NIRS measurements|Brain tissue oxygenation ( oxy- or deoxygenated hemoglobin values) - NIRS
16051238|NCT02516774|Drug|Adalimumab|
16051239|NCT02516761|Other|Low-impact aerobic exercise combined with music therapy|Intervention consists in working the muscles which are mostly affected by fibromyalgia through group exercises, which are dynamic, smooth and aim functionality. Each session consists of 60 minutes with 3 parts: initial warming up time, main part through games, group dynamics and pure aerobic workout, and final cool down with stretching. This exercise is done to the rhythm of melodic music, adapted to the tastes of the participants and also adapted on the way to perform the exercise. For this, they were shown a list of 100 music compositions from which participants choose a minimum of 20 preferences. All exercises are performed with proper postural control both dissociated and global and within a framework of therapeutic proprioceptive gymnastics.
16051297|NCT02516410|Drug|VX-661 plus ivacaftor combination|
16051298|NCT02516410|Drug|Ivacaftor|
16051240|NCT02516761|Other|Low-impact aerobic exercise|Low-impact aerobic exercise. Then intervention is like the previous group but with the difference that physical activity is not performed to the rhythm of chosen melodic music. Therefore, exercises are done with general chill-out music throughout the session, without adaptation of the exercise to the music.
16051241|NCT02516761|Other|Control group|With this group no intervention is done, but they are assessed like the other groups.
16051242|NCT02516748|Behavioral|Feedback|Less experienced endoscopists in optical diagnosis will receive feedbacks about their own accuracy of optical diagnosis.
16051243|NCT02516735|Device|I-scan with magnification|
16051244|NCT02516735|Device|Standard endoscopy|
16051245|NCT02516722|Device|Therapeutic Intra-Vascular UltraSound (TIVUS™) System|"The TIVUS™ System generates high intensity, non-focused ultrasonic energy that is delivered through the wall of the pulmonary artery to achieve local nerve deactivation.
~Denervation in the pulmonary arteries (PDN) would be performed during right heart catheterization. The PDN procedure would be attempted in the main, right and left pulmonary arteries, close to the main bifurcation."
16051246|NCT02516709|Radiation|Linear LDR Source|The Linear LDR source is a permanent interstitial brachytherapy implant containing palladium-103 sources for the treatment of prostate cancer.
16051247|NCT02516696|Drug|Clarithromycin|500mg PO twice daily on days 1-28 for a 28-day cycle.
16051248|NCT02516696|Drug|Lenalidomide|25 mg PO days 1-21 followed by a 7 day rest period for each 28-day cycle
16051249|NCT02516696|Drug|Dexamethasone|20 mg PO on Days 1, 8, 15, and 22 for each cycle for subjects 75 years and younger.
16051250|NCT02516683|Other|Shigella sonnei infection|A Shigella-exposed cohort of 124 hospital employees who had been infected by Shigella sonnei due to contaminated food in the employee-cafeteria in Gangnam Severance Hospital, Seoul, Korea, at December 2001.
16051251|NCT02516670|Dietary Supplement|Ascorbic Acid|Given IV
16051252|NCT02516670|Drug|Docetaxel|Given IV
16051253|NCT02516670|Other|Laboratory Biomarker Analysis|Correlative studies
16051254|NCT02516670|Other|Pharmacological Study|Correlative studies
16051255|NCT02516670|Other|Placebo|Given IV
16051256|NCT02516670|Other|Quality-of-Life Assessment|Ancillary studies
16051257|NCT02516657|Drug|Liraglutide|Liraglutide 0.6 mg
16051258|NCT02516644|Behavioral|Virtual Reality|12 sessions of 1 hour (30 min of virtual reality and 30 min of aerobic exercise with treadmill training): three times a week over four weeks
16051259|NCT02516644|Behavioral|Conventional Therapy|12 sessions of 1 hour of conventional physiotherapy: three times a week over four weeks
16051260|NCT02516631|Drug|Angusta™|One tablet of Angusta™ (25 µg) given every 2 hours
16051261|NCT02516631|Drug|Cytotec®|1/8 of a tablet of Cytotec® (25 µg) given every 2 hours. Drug administration should be repeated every 2 hours until labour has commenced.
16051262|NCT02516631|Drug|Angusta™|Two tablets of Angusta™ 25 µg given every 4 hours
16051263|NCT02516631|Drug|Cytotec®|¼ of a tablet of Cytotec® given every 4 hours. Drug administration should be repeated every 4 hours until labour has commenced.
16051264|NCT02516631|Drug|Angusta™|Two tablets of Angusta™ (total dose of 50 µg), given every 4 hours
16051265|NCT02516631|Drug|Cytotec®|¼ of a tablet of Cytotec® (50 µg), given every 4 hours. Subjects should not swallow for a period of 5 minutes. Drug administration should be repeated every 4 hours until labour has commenced.
16051266|NCT02516618|Drug|Fasinumab|
16051267|NCT02516618|Drug|Placebo|
16051268|NCT02516605|Drug|Part 1: LJN452|LJN452 capsules administered once daily for 28 days
16051269|NCT02516605|Drug|Part 1: Placebo|Matching placebo capsules administered once daily for 28 days
16051270|NCT02516605|Drug|Part 2: LJN452 Dose level 1|LJN452 capsules administered once a day for 12 weeks
16051271|NCT02516605|Drug|Part 2: Placebo|Matching placebo to LJN452 administered once a day for 12 weeks
16051272|NCT02516605|Drug|Part 2: LJN452 Dose level 2|LJN452
16051273|NCT02516592|Drug|QVA149 110/50 micrograms|QVA149 110/50 micrograms o.d. capsules for inhalation, supplied in blisters via a single dose dry powder inhalater (SDDPI)
16051274|NCT02516592|Drug|Salmeterol/fluticasone 50/500 microgrammes|Salmeterol/fluticasone 50/500 microgrammes b.i.d.dry inhalation powder delivered via Accuhaler / Diskus device
16051275|NCT02516579|Drug|Siklos|
16051276|NCT02516566|Other|PEEP|Mechanical ventilation with PEEP 8 cmH2O
16051277|NCT02516553|Drug|BI 894999|day 1 to day 21 in 3-week cycles
16051278|NCT02516553|Drug|BI 894999|day 1 to day 14 followed by a week off in 3-week cycles in schedule B
16051279|NCT02516553|Drug|BI 894999|one week on followed by one week off treatment, repeated every two weeks in 4-week cycles
16051280|NCT02516540|Behavioral|Structured exercise training plus mediterranean diet|Structured exercise training plus mediterranean diet
16051281|NCT02516527|Drug|Ipilimumab|
16051282|NCT02516514|Procedure|Single-sampling strategy vs multi-sampling strategy for the diagnosis of bacteremia|Comparison between two strategies of blood culture (single-sampling strategy and multi-sampling strategy) for the diagnosis of bacteremia
16051283|NCT02516501|Dietary Supplement|MyAmino|MyAmino is a supplement containing the eight essential amino acids. MyAmino has a theoretical net nitrogen utilization of 99%, so that almost no glucose will be created out of the maino acids.
16051284|NCT02516501|Dietary Supplement|betaquik|betaquik is a medium chain triglyceride (MCT) emulsion. One bottle is 225ml corresponding to 45g MCT fats.
16051285|NCT02516501|Radiation|Radio(chemo)therapy|Radio(chemo)therapy as recommended by the institutional interdisciplinary tumor board.
16051286|NCT02516475|Dietary Supplement|zinc sulfate|1 zinc sulfate capsule for 15 weeks
16051287|NCT02516475|Other|corn starch|1 corn starch capsule for 15 weeks
16051288|NCT02516462|Device|IVM media|Media to support the nuclear maturation and cytoplasmic competence of human oocytes in culture.
16051289|NCT02516462|Drug|Follicle Stimulating Hormone (FSH)|Low dose FSH is administered to stimulate follicle growth.
16051290|NCT02516449|Other|Patient decision aid|"The patient decision aid is a 12-page A3 size color-printed booklet entitled Should I take asthma inhaled controller medication to optimize asthma control?"
16051291|NCT02516436|Drug|BEMA Buprenorphine NX|Buprenorphine with naloxone
16051292|NCT02516436|Drug|Buprenorphine|Buprenorphine
16051293|NCT02516423|Drug|ixazomib|oral
16051299|NCT02516410|Drug|Placebo (matched to VX-661 plus ivacaftor combination)|
16051300|NCT02516410|Drug|Placebo (matched to ivacaftor)|
16051301|NCT02516397|Dietary Supplement|Omnia|12weeks of treatment
16051302|NCT02516397|Dietary Supplement|Placebo|12weeks of treatment
16051303|NCT02516384|Biological|Fecal Microbiota Transplantation|We will use fecal microbiota transplantation (FMT), with fecal material obtained from OpenBiome or donor directed, to assess safety (as primary outcome) and efficacy (as secondary outcome) in adult (>18 year old) patients with active ulcerative colitis (UC).
16051304|NCT02516371|Other|lymphocyte|To evaluate the subpopulation of lymphocytes in cancer patients
16051305|NCT02516345|Device|Fitbit|Fitbit devices are wireless pedometers that track the steps of participants, and will be offered in conjunction with a tailored website with customized information for participants.
16051306|NCT02516345|Behavioral|Incentives|Incentives will be awarded to participating children for meeting step targets as measured by the Fitbit pedometer.
16051307|NCT02516332|Drug|Lexapro|
16051308|NCT02516332|Drug|Placebo|
16051309|NCT02516332|Behavioral|Supervised Aerobic Exercise|
16051310|NCT02516319|Drug|ICG Dye|
16051311|NCT02516306|Drug|EV06 Ophthalmic Solution|
16051312|NCT02516306|Drug|Placebo Ophthalmic Solution|
16051313|NCT02516293|Behavioral|Exercise, nutritional and pharmaceutical counseling|Physical exercise intervention protocol was performed three times per week, 60 minutes per session, during 8 months. Exercise sessions consisted of 30 minutes of aerobic exercise on a treadmill or on a cycle ergometer, 20 minutes of strength exercises for the major muscle groups (sit-ups, push-ups, and pull-ups), and 10 minutes of stretching exercises. Nutritional and pharmaceutical consisted on general guidance about adequate eating habits for patients with heart failure, mainly sodium and water intake, and medication usage, particularly drug dosage and compliance.
16051314|NCT02516280|Device|Cryoton ™|In the intervention group, participants received hyperbaric gaseous cryotherapy delivered with a Cryoton ™ device (Cryonic Médical, Salins-les-Bains, France) within an hour after the surgery and two times per day the next postoperative days. The tip of the nozzle was kept 10-15 cm above the dry skin as the gaseous CO2 was sprayed on three zones of 5 cm by 10 cm (medial, lateral and posterior, respectively) using a slow and regular sweeping movement for approximately 30 seconds after a skin temperature of 2°C is reached.
16051315|NCT02516280|Device|Control ice bag|In the control group, participants received two 20-minute treatments of cryotherapy within an hour after the surgery and two times per day the next postoperative days. Cryotherapy was performed using an ice bag that was applied directly on the anterior aspect of the knee. The ice bag is a square latex bag of 30 cm by 30 cm filled with crushed ice and wrapped in a thin pillow case. The treatment assessor applied the intervention in a standardized manner by ensuring that the knee was fully extended while covering the surgical incision and both lateral and medial aspects of the knee with the iced bag.
16051316|NCT02516267|Device|Multiplate ADP®|Patients will be evaluated by platelet function testing (Multiplate ADP®) daily until the value obtained> 46 AU, when they will be immediately released to CABG
16051317|NCT02516254|Dietary Supplement|fortified bread|50 g of fortified bread + placebo daily
16051318|NCT02516254|Dietary Supplement|supplement|vitamin D supplement+ plain bread
16051319|NCT02516254|Dietary Supplement|placebo|plain bread+placebo
16051320|NCT02516241|Drug|MEDI4736 (Durvalumab)|IV infusion
16051321|NCT02516241|Drug|Tremelimumab|IV infusion
16051322|NCT02516241|Drug|Cisplatin|IV infusion
16051323|NCT02516241|Drug|Carboplatin|IV infusion
16051324|NCT02516241|Drug|Gemcitabine|IV infusion
16051325|NCT02516228|Device|GTEN 100|"Stimulation will be focused on the seizure generating cortex. All patients enrolled in the study will have a pre-treatment baseline evaluation period. During this time, the patient (and/or family) will maintain the seizure diary that simply tracks the number of seizure the patient experiences each day.
~During this baseline period, two two-hour EEG recordings (to be completed on 2 separate days) will be acquired. This baseline EEG data will be used to establish baseline inter-ictal spike rate as well as classification of the inter-ictal spikes used to localize seizure onset zone. Using the localization information, patients will be treated with the device for five concurrent days."
16051326|NCT02516215|Other|No intervention|
16051327|NCT02516202|Drug|Vagifem|One tablet is to be inserted vaginally daily for 2 weeks, then 2 days/week for the remaining 10 weeks of the study.
16051328|NCT02516202|Device|Replens|2.5 gm to be applied vaginally every 3 days over 12 weeks.
16051329|NCT02516202|Other|Placebo tablet|Dispensed in visually identical bottle and tablet form to Vagifem.
16051330|NCT02516202|Other|Placebo gel|Dispensed in visually identical tube and gel form to Replens.
16051331|NCT02516189|Other|Strength training program|"Strength Training program applied twice a week for sixteen weeks. Each training exercises has a total time of 50 minutes. Warm-up: 5 minutes of stretching. Training: Leg press; Leg Curl; Vertical traction; Chest press; Abdominal crunch; Lower back. Gametherapy.
~Relaxation: 5 minutes of stretching."
16051332|NCT02516176|Behavioral|treadmill training|Paretic leg step training while standing on a treadmill sideways and responding to treadmill being turned on suddenly.
16051333|NCT02516163|Device|Shapematch Cutting Guides|Participants will undergo pre-operative assessment using MRI of the affected limb. At the time of surgery, a repeated-measures methodology will be implemented in which the position of the femoral and tibial cutting guides will be measured using the Navigation system. The same surgeon will position each cutting guide a total of 3 times for each patient. Multiple participants will be assessed by each surgeon. No bone cuts will take place using the patient-specific cutting guides. After the study-specific measurements have been taken, the total knee procedure will resume using the Navigation system and associated instruments. No post-operative evaluations will be undertaken as part of this sub-study
16051334|NCT02516150|Drug|Ethanol|IV infusion of ethanol to stabilize BAC (blood alcohol content) at 0.1%
16051335|NCT02516150|Drug|Glucagon|injection of 50 micrograms of glucagon
16051380|NCT02515877|Drug|Vistide|VISTIDE® (mg/kg) Level 1: 1mg/kg Level 2: 2,5 mg/kg Level 3: 5 mg/kg Level 4: 6,5 mg/kg
16051381|NCT02515877|Drug|Carboplatin|AUC= 2,5 (Calvert formula)
16051382|NCT02515864|Drug|FYU-981|
16051383|NCT02515864|Drug|Placebo|
16051384|NCT02515864|Drug|Moxifloxacin|
16051385|NCT02515864|Drug|Moxifloxacin Placebo|
16051336|NCT02516137|Procedure|Dry needling|Dry needling will be performed on two points over the hamstring muscles on the randomly determined side. Points 2 cm distal to the ischial tuberosity and halfway between the ischial tuberosity and popliteal crease within the medial and lateral muscle bellies will be identified and the skin cleansed with rubbing alcohol. A Seirin L- type 50 mm needle will be inserted into each of the two points to a depth no greater than three-quarters length of the needle into the hamstring muscle for 30 seconds using a vertical pistoning technique and then statically up to 10 minutes.
16051337|NCT02516137|Procedure|Sham needling|Sham dry needling will be performed on two points over the hamstring muscles on the randomly determined side. Points 2 cm distal to the ischial tuberosity and halfway between the ischial tuberosity and popliteal crease within the medial and lateral muscle bellies will be identified and the skin cleansed with rubbing alcohol. The plastic tube of a Seirin L- type 50 mm needle will be placed against the skin and the needle will be tapped once so that it is inserted subcutaneously no deeper than 5 mm for 30 seconds using a vertical pistoning technique and then statically up to 10 minutes in each location.
16051338|NCT02516137|Procedure|Blunt needle placement|Blunt needle placement will be performed on two points over the hamstring muscles on the randomly determined side. Points 2 cm distal to the ischial tuberosity and halfway between the ischial tuberosity and popliteal crease within the medial and lateral muscle bellies will be identified and the skin cleansed with rubbing alcohol. A blunt needle handle is inserted into a plastic tube which will be placed over the identified points for 30 seconds and then for an additional 10 minutes each. The blunt needle handle only touches the skin without puncturing it.
16051339|NCT02516137|Other|Standard hamstring stretching exercise|Subjects will be instructed to stretch the back of their thighs, once a day for 3 repetitions, holding for 30 seconds each time performed bilaterally.
16051340|NCT02516124|Procedure|Autologous HSCT|1st AHSCT
16051341|NCT02516111|Procedure|Open flap debridement (OFD)|Oral prophylaxis followed by Open flap debridement (OFD)
16051342|NCT02516111|Biological|OFD with PRF|Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into the bone defect
16051343|NCT02516111|Drug|OFD with ALN|Oral prophylaxis followed by Open flap debridement (OFD) with 1% ALN gel placement into the bone defect
16051344|NCT02516111|Drug|OFD with ATV|Oral prophylaxis followed by Open flap debridement (OFD) with 1.2% ATV gel placement into the bone defect
16051345|NCT02516098|Drug|hyoscine butylbromide|
16051346|NCT02516085|Drug|Metformin|
16051347|NCT02516085|Drug|L-Arginine|
16051348|NCT02516072|Other|RIPC|IV hydration prior to procedure dependent on classification of risk as per eGFR + RIPC
16051349|NCT02516059|Drug|oxycodone/naloxone|Oxycodone and naloxone (Targin®; Mundipharma Medical Company and Mundipharma Research GmbH & Co Basel, Switzerland): Will be orally administered at 12 hours intervals, starting with 10mg/5mg on POD 3 and move to 20mg/10mg the other day.
16051350|NCT02516059|Drug|Oxycodone|Oxycodone (Oxycontin®, Mundipharma Medical Company and Mundipharma Research GmbH & Co Basel, Switzerland): Will be orally administered at 12 hours intervals, starting with 10 mg on POD 3 and move to 20 mg the other day.
16051351|NCT02516059|Drug|Placebo|Placebo (Mundipharma Medical Company and Mundipharma Research GmbH & Co Basel, Switzerland): Will be orally administered at 12 hours intervals starting on POD 3.
16051352|NCT02516059|Device|epidural catheter|
16051353|NCT02516046|Drug|Flortaucipir F18|370 megabecquerel (MBq) IV single-dose
16051354|NCT02516046|Procedure|PET Scan|positron emission tomography (PET) scan
16051355|NCT02516020|Drug|Global|Embryos are cultured in single step culture from day 1 to day 5
16051356|NCT02516020|Drug|Origio|Embryos are cultured in sequential medium from Day1 to Day 3 and from Day 3 to Day 5 (Sequential Blast)
16051357|NCT02515994|Device|senofilcon C|Investigational contact lens
16051358|NCT02515994|Device|comfilcon A|Marketed Monthly Replacement Lens (Control)
16051359|NCT02515981|Behavioral|NH Medicaid Incentives Program|
16051360|NCT02515968|Drug|Desflurane|Anesthesia is maintained with desflurane in Desflurane group according to the randomly allocated groups.
16051361|NCT02515968|Drug|Propofol|
16051362|NCT02515955|Drug|JNJ-54175446|Participants will receive JNJ-54175446, at increasing dose levels using 2 oral formulations i.e. 0.5 mg/ml and 20 mg/ml as suspension for oral dose once daily.
16051363|NCT02515955|Drug|Minocycline|Participants will receive minocycline 100 mg as capsule twice daily.
16051364|NCT02515955|Drug|JNJ 54175446 Matching Placebo|Participants will receive placebo matching with JNJ 54175446 once daily orally.
16051365|NCT02515955|Drug|D Amphetamine|Participants will receive 20 mg d-amphetamine (AMPH) 2 hours after administration of study drug (JNJ-54175446/placebo or minocycline/placebo) on Day 7 and Day 10.
16051366|NCT02515955|Drug|D Amphetamine Matching Placebo|Participants will receive d-amphetamine (AMPH) matching placebo, 2 hours after administration of study drug (JNJ-54175446/placebo or minocycline/placebo) on Day 7 and Day 10.
16051367|NCT02515942|Drug|CLG561|
16051368|NCT02515942|Drug|LFG316|
16051369|NCT02515942|Drug|Sham injection|Empty syringe (without a needle) placed against the eye
16051370|NCT02515929|Dietary Supplement|Oligomeric Proanthocyanidins|
16051371|NCT02515929|Dietary Supplement|Placebo|
16051373|NCT02515903|Procedure|Intra-endoscopic surgery|Intra-endoscopic surgery for evacuation of ICH
16051374|NCT02515903|Procedure|Placebo:stereotactic aspiration surgery|Placebo:stereotactic aspiration surgery for evacuation of ICH
16051375|NCT02515890|Drug|Dexmedetomidine|Selected subjects received this drug during a portion of the study
16051376|NCT02515890|Drug|Midazolam|Selected subjects received this drug during a portion of the study
16051377|NCT02515890|Device|Peripheral nerve stimulation|Experimental acute pain stimulus was delivered using a nerve stimulator. These painful shocks were paired randomly with some of the auditory experimental cues.
16051378|NCT02515890|Drug|Ketamine|Selected subjects received this drug during a portion of the study
16051379|NCT02515877|Radiation|External radiotherapy + curietherapy|External radiotherapy: 45 Gy in 5 weeks Curietherapy: 15Gy
16051386|NCT02515851|Drug|Exparel|
16051387|NCT02515851|Drug|Placebo|
16051388|NCT02515838|Drug|Sevuparin|The Drug Product sevuparin solution for IV infusion
16051389|NCT02515838|Other|Placebo|Placebo for IV infusion
16051390|NCT02515825|Device|CADence|
16051391|NCT02515812|Drug|I-123-MIBG|
16051392|NCT02515812|Device|CZT Camera (D-SPECT)|
16051393|NCT02515812|Device|Anger Camera|
16051394|NCT02515799|Drug|Tacholiquine|Inhaled Tacholiquine ®1% - 5ml
16051395|NCT02515799|Other|Placebo|Inhaled Placebo
16051396|NCT02515786|Other|oxygen humidification|humidification for oxygen delivered by nasal catheter
16051397|NCT02515773|Drug|Metformin|Metformin - to achieves maximum insulin-sensitizing effects
16051398|NCT02515773|Behavioral|healthy lifestyle intervention (LIFE)|Healthy Life style intervention
16051399|NCT02515760|Procedure|Bone marrow aspiration from the iliac crest|
16051400|NCT02515760|Device|Illinois bone marrow aspiration neddle|
16051401|NCT02515747|Procedure|percutaneous coronary intervention|elective percutaneous coronary balloon angioplasty and/or stenting
16051402|NCT02515747|Procedure|coronary artery bypass grafting|elective surgical myocardial revascularisation
16051403|NCT02515734|Drug|fluorouracil|
16051404|NCT02515734|Drug|Leucovorin|
16051405|NCT02515734|Drug|irinotecan|
16051406|NCT02515734|Drug|oxaliplatin|
16051407|NCT02515734|Biological|bevacizumab|
16051408|NCT02515734|Biological|cetuximab|
16051409|NCT02515721|Device|pCLE-TB|Patients will receive white-light endoscopic imaging, followed by probe-based Confocal Laser Endomicroscopy scanning on suspected lesions and 5 standardized locations. Then targeted Biopsies will be performed on locations with intestinal metaplasia, intraepithelial neoplasia, and carcinoma.
16051410|NCT02515721|Device|virtual chromoendoscopy-TB|Patients will receive virtual chromoendoscopy using iScan. Standard biopsies will be performed on all suspected lesions and standardized loctaions.
16051411|NCT02515708|Device|Normothermic Liver perfusion Device|The liver grafts will be preserved at physiological temperature and have continuous perfusion with oxygen and nutrient supply in the ex vivo organ preservation phase.
16051412|NCT02515695|Drug|Interferon beta-1a|6 MIU/0.53 mL in pre-filled glass syringe solubilized in aqueous isotonic buffered solution
16051413|NCT02515682|Dietary Supplement|High equol group|Participants will be give natural S-equol 20mg/d for 24 weeks.
16051414|NCT02515682|Dietary Supplement|Low equol group|Participants will be give natural S-equol 10mg/d for 24 weeks.
16051415|NCT02515682|Dietary Supplement|Placebo|Participants will be give placebo for 24 weeks.
16051416|NCT02515669|Drug|RO7239361|Colorless to slightly yellow, clear to opalescent solution, essentially free of particulate matter packaged in a 1 cc glass syringe equipped with a safety syringe device.
16051417|NCT02515669|Drug|Placebo|Colorless to slightly yellow, clear to opalescent solution, essentially free of particulate matter packaged in a 1 cc glass syringe equipped with a safety syringe device.
16051418|NCT02515656|Drug|POLYGYNAX®|
16051419|NCT02515656|Drug|GYNODAKTARIN®|
16051420|NCT02515656|Drug|Placebo|
16051421|NCT02515643|Other|Endothelial dysfunction|"One month before surgery and one year after, the following procedures will be performed in donors and recipients:
~Blood samples will be obtained for the measurement of endothelial dysfunction and low grade inflammation markers.
~Atherosclerotic burden: carotid ultrasound to determine the number of plaques and intima-media thickness, carotid-femoral pulse wave velocity (m/s) will be performed by pulse tonometry.
~Ambulatory blood pressure monitoring with overnight-automated ABPM monitor
~Estimation of glomerular filtration rate by Iohexol method"
16051422|NCT02515630|Drug|MMB|Momelotinib (MMB) tablet administered orally once daily
16051423|NCT02515617|Device|Endotracheal tubes not allowing SSD|In each participating center, a bundle of VAP prevention will be applied: elevate the head of the bed to 30°-45°, regular oral care, manage patients with sedation algorithm, assess readiness to extubate daily, intermittent control of endotracheal tube cuff pressure
16051424|NCT02515617|Device|Endotracheal tubes allowing SSD|"In each participating center, a bundle of VAP prevention will be applied: elevate the head of the bed to 30°-45°, regular oral care, manage patients with sedation algorithm, assess readiness to extubate daily, intermittent control of endotracheal tube cuff pressure.
~In addition, SSD will be realized using a 10 ml syringe at in attending frequency of 2 hours."
16051425|NCT02515604|Drug|Misoprostol|
16051426|NCT02515591|Other|Bronchoalveolar Lavage validation study|Bronchoalveolar lavage involved the washing out of the right middle lobe of the lung of a healthy volunteer with 200mls of warmed normal saline with or without sedation.
16051427|NCT02515578|Other|Enhanced practice transformation support|
16051428|NCT02515578|Other|Standard practice transformation support|
16051429|NCT02515565|Drug|cephalosporin with or without erythromycin|Second- or third-generation cephalosporin (cefuroxime, cefotaxime, or ceftriaxone) with or without erythromycin, given parenterally; parenteral therapy should continue until the patient has been afebrile for more than 24 hours and oxygen saturation exceeds 95 percent.
16051430|NCT02515565|Other|Physiotherapy program|The physiotherapy treatment will be performed during the hospitalization, every day during 45-60 minutes added to the standard medical treatment. I will include breathing exercises, electrostimulation in quadriceps with voluntary contraction and exercises with theraband.
16051431|NCT02515552|Behavioral|The Fibromyalgia Wellness Project|Web-based symptom and behavior self-monitoring program with automated feedback derived from the user's personal data. A personal informatics approach is used involving proprietary within-subject statistical analysis procedures to determine user feedback that provides behavioral guidance based on statistically significant change in symptom levels associated with specific user behavior and self-management strategies.
16051432|NCT02515539|Device|CardiAQ TMVI System (Transapical & Transfemoral DS)|CardiAQ TMVI System using either the Transapical or Transfemoral Delivery System
16051433|NCT02515526|Drug|caffeine, tolbutamide, omeprazole, dextromethorphan, digoxin, midazolam single doses|Reference period
16051434|NCT02515526|Drug|ethanol multiple doses plus caffeine, tolbutamide, omeprazole, dextromethorphan, digoxin, midazolam single doses|Test period
16051466|NCT02515305|Drug|Placebo gel (combination)|
16051467|NCT02515279|Drug|Peginterferon alfa-2a|180 micrograms subcutaneous weekly for 48 weeks.
16051468|NCT02515279|Drug|Ribavirin|1000-1600 mg day orally for 48 weeks.
16051435|NCT02515513|Procedure|Muscle Tissue Biopsy Sample|During surgical resection, to enter the abdominal cavity, anterior muscle groups such as the rectus abdominous muscle. This group of muscle is divided. During division, muscle fibers are released from fascial group and discarded off the operative field. This will be the target for specimen collection.
16051436|NCT02515500|Behavioral|Gradual Cessation|
16051437|NCT02515500|Behavioral|Gradual Cessation w/ Quitbit|
16051438|NCT02515487|Other|Brain Fitness Program (BFP)|The program is designed to improve processing speed of auditory information and attention. The BFP is comprised of six computerized subtests that continuously adjust in the level of difficulty to maintain an 85% correct response rate. The subtest exercises include discrimination of confusable syllables, recognition of sequences of syllables, matching pairs of confusable syllables, reconstruction of sequences of verbal instructions and identification of details in a verbally presented story. Participants will participate in 40 one-hour training sessions over a 12 week period to complete all cognitive remediation training sessions. Since this intervention is presented both visually and verbally, noise cancelling headphones will be provided to the participants.
16051439|NCT02515474|Procedure|Laparoscopy|After removing the gallbladder, Laparoscopic common bile duct exploration (LCBDE) was performed by one fulltime attending in laparoscopy in a routine fashion. Access from the opening of the anterior wall of common bile duct or from the dilated cystic duct was acceptable, removed stone(s) and irrigated the duct followed by choledochoscope detection simultaneously. Cholangiograms were also can be a alternative method to obtain stone clearance. If needed, all fluoroscopy was performed by the principal author in the presence of and concurrence with the ERCP endoscopist. Once the LCBDE was completed, the incision of the bile duct was sewed intermittently by absorbed threads, or ligated cystic duct. T-tube was acceptable if needed.
16051440|NCT02515474|Procedure|Endoscopy|Initially endoscopic retrograde cholangiopancreatography (ERCP) was performed by a fulltime attending and concurrence of the principal author in endoscopy. Patients randomized to ERCP+ LC group were scheduled to undergo the endoscopic procedure using fluoroscopy in the endoscopy center under moderate sedation (principally intravenous midazolam and meperidine) prior to the intended laparoscopy. Gastric intestinal atony during ERCP was routinely achieved using scopolamine butylbromide injection. Sphincterotomy (EST) and Endoscopic papillary balloon dilatation (EPBD) can be choose accordingly. The laparoscopic cholecystectomy was subsequently performed as soon as technically feasible following the ERCP in one month.
16051441|NCT02515461|Device|Low energy shockwave therapy|"Procedure: The patient lies on supine position during treatment. Kidney will be localised in line ultrasound. 3000 shockwaves at a frequency of 4 Hz are applied to each kidney per session. The kidney will be divided into three treatment areas including 1000 shockwaves applied to each treatment area.
~Patients will receive 6 sessions over 3 weeks. Treatments are carried out on day 1, day 3, day 7, day 10, day 14, and day 17 after enrollment (average time points).
~Treatment is performed using the MODULITH SLX-F2, manufactured by STORZ MEDICAL AG."
16051442|NCT02515448|Drug|gentamicin|
16051443|NCT02515435|Drug|apatinib single agent|For those heavily treated non-squamous non-small cell lung cancer, treat with apatinib single agent, 500mg or 750mg Qd, p.o based on the status of patient, continue until disease progression, dose reduction was admitted
16051444|NCT02515422|Drug|Ketamine|Subcutaneous infiltration of ketamine
16051445|NCT02515422|Drug|Bupivacaine|Subcutaneous infiltration of bupivacaine
16051446|NCT02515422|Drug|Placebo (0.9% saline solution)|
16051447|NCT02515409|Device|HHHFNC|After the treatment with CPAP fails, the participants will use HHHFNC as a treatment for OSAS.
16051448|NCT02515409|Device|CPAP|CPAP, as a first line treatment in OSAS.
16051449|NCT02515396|Drug|MMI-0100|
16051450|NCT02515396|Drug|Placebo|
16051451|NCT02515383|Other|Interview|Complete cognitive debriefing interview
16051452|NCT02515383|Other|Quality-of-Life Assessment|Ancillary studies
16051453|NCT02515383|Other|Questionnaire Administration|Complete MDASI questionnaire
16051454|NCT02515370|Other|Friends for Life Circles (FLCs).|"The intervention 'Friends for Life Circles (FLCs) will build dynamic peer group support in the community aimed at supporting maternal adherence to appointment keeping and taking lifetime antiretroviral drugs"
16051455|NCT02515357|Behavioral|Mediterranean lifestyle|Comprehensive 6-month lifestyle intervention (7 60-min group counselling sessions) aiming at promoting adherence to the Mediterranean lifestyle (food and food group consumption according to the Mediterranean diet, beneficial culinary practices, seasonality and locality of foods consumed, socialization during meals, adequate rest during the day through night sleep and siesta nap, sleep hygiene recommendations and adoption of a physically active lifestyle) and at achieving a 5-10% weight loss.
16051456|NCT02515357|Behavioral|Standard care|General written instructions regarding the adoption of a healthy lifestyle.
16051457|NCT02515357|Behavioral|Mediterranean diet|Comprehensive 6-month lifestyle intervention (7 60-min group counselling sessions) aiming at promoting adherence to the Mediterranean dietary pattern (food and food group consumption according to the Mediterranean diet, beneficial culinary practices and seasonality and locality of foods consumed) and at achieving a 5-10% weight loss.
16051458|NCT02515344|Other|Providing a list of patients not compliant with CRC sreening|GPs allocated to the intervention group (A) will receive a list of the patients who are not compliant to colorectal cancer screening, while GPs allocated to the others groups will not receive this information.
16051459|NCT02515344|Other|Providing general information about CRC sreening|
16051460|NCT02515331|Drug|LHW090|Capsule - oral dose
16051461|NCT02515331|Drug|Placebo|Capsule - oral dose
16051462|NCT02515318|Other|Physiotherapy program|The physiotherapy treatment will be performed during the hospitalization, every day during 45-60 minutes, and included: breathing exercises, electrostimulation in quadriceps with voluntary contraction and exercises with theraband.
16051463|NCT02515318|Drug|Medical standard treatment|"The standard medical treatment consists on:
~Inhaled bronchodilators: Short acting inhaled β2 agonists ( salbutamol and terbutaline) and anticholinergic agents (ipratropium and oxitropium bromide).
~Glucocorticoids:
~Inhaled glucocorticoids including beclomethasone dipropionate, budesonide, flunisolide, fluticasone propionate and triamcinolone acetonide, depending on the expert criteria.
~- Antibiotics: The antibiotics were administered according to the GOLD criteria including the β-lactamase inhibitor and fluoroquinolones."
16051464|NCT02515305|Drug|Clindamycin and Benzoyl Peroxide Gel (combination)|
16051465|NCT02515305|Drug|Clindamycin and Benzoyl Peroxide Gel (Reference) (combination)|
16051469|NCT02515266|Other|nutrition: protein intake|additional protein fortification of human milk
16051470|NCT02515253|Other|Bra prescription|
16051471|NCT02515253|Other|Standard Care|
16051472|NCT02515240|Biological|PPV23|23 valent pneumococcal polysaccharide vaccine in Healthy adults.
16051473|NCT02515227|Biological|6MHP|6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
16051474|NCT02515227|Drug|Pembrolizumab|Humanized monoclonal antibody (mAb) specific for PD-1.
16051475|NCT02515201|Drug|Taurolidine|taurolidine in central catheter lumen
16051476|NCT02515201|Drug|Heparin|heparin in central venous catheter lumen
16051477|NCT02515188|Drug|Propacetamol|Randomly selected patients of the propacetamol group are given intravenous propacetamol 2g for 15 minutes on the beginning of the procedure.
16051478|NCT02515188|Drug|Placebo|Placebo group are given intravenous Normal Saline 2g for 15 minutes on the beginning of the procedure.
16051479|NCT02515175|Biological|Matrix-M2|Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
16051480|NCT02515175|Biological|GEN-003|HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
16051481|NCT02515175|Drug|Placebo|0.9% Normal Saline
16051482|NCT02515162|Procedure|Fischer Cone Biopsy Excisor|Electrosurgical excision method using a triangular electrode to remove the abnormal cervical Transformation zone
16051483|NCT02515162|Procedure|Loop Excision Procedure|Electrosurgical excision method using a circular electrode to remove the abnormal cervical Transformation zone
16051484|NCT02515149|Device|Point of care CD4 device (Alere PIMA)|for persons testing + with home-based HIV testing using Kenya's two rapid test algorithm, intervention arm participants received point of care CD4 testing followed by counseling on results which included their treatment eligibility
16051485|NCT02515136|Behavioral|Stimulus-response|See summary
16051486|NCT02515123|Device|E-Motion System|"E-Motion Tube: A disposable oro/nasogastric feeding tube fitted with stainless steel electrodes along its length that delivers the stimulation to the esophageal mucosa.
~E-motion EPG 1000: a durable, touchscreen operated, bedside control unit that generates the electric stimulation pattern and sends it via the feeding tube to the esophagus.
~By applying predetermined sequences of electrical stimulation to various locations along the esophagus asynchronous esophageal motion is induced, resulting is reduction of reflux and increased GI motility, enabling safer and better feeding."
16051487|NCT02515123|Device|Sham E-Motion System|The sham EPG will resemble the investigational EPG. The external shape, interface, lights, and switches will be exactly the same. The Sham device will emit a low intensity pulsation so that, it will not unblind the patient nor health care professional. In the event that unblinding does occur, we will take steps to mask the identity of the EPG by covering the number of the device with tape to prevent members of the clinical team becoming aware of which device is active or sham.
16051488|NCT02515110|Radiation|External Beam Radiation Therapy|Undergo hypofractionated RNI
16051489|NCT02515110|Other|Questionnaire Administration|Ancillary studies
16051490|NCT02515110|Other|Laboratory Biomarker Analysis|Correlative studies
16051491|NCT02515097|Drug|IDP-122 Lotion|Medicated topical lotion
16051492|NCT02515097|Drug|IDP-122 Vehicle Lotion|Vehicle topical lotion with no active ingredient
16051493|NCT02515084|Device|PET|A FDG PET scan and a diffusion-weighted Magnetic Resonance Imaging will be performed to compare the efficacy to diagnose relapse in thyroid carcinoma
16051494|NCT02515084|Device|MRI imaging|
16051495|NCT02515071|Dietary Supplement|Dietary nitrate|140ml of nitrate rich beetroot juice provides 12.9mmol nitrate and will be consumed on a daily basis during the intervention by the study subjects.
16051496|NCT02515071|Dietary Supplement|Placebo|140ml of nitrate depleted beetroot juice provides 0.5mmol nitrate and will be consumed on a daily basis during the intervention by the study subjects.
16051497|NCT02515058|Device|PUROS (Ridge Preservation bone grafting surgery)|Ridge preservation bone grafting after tooth extraction
16051498|NCT02515058|Device|FDBA (Ridge Preservation bone grafting surgery)|Ridge preservation bone grafting after tooth extraction
16051499|NCT02515045|Drug|TriMoxiVanc|triamcinolone acetonide 15 mg / ml with moxifloxacin 1 mg/ml, vancomycin 10 mg/ml to be injected at time of cataract surgery.
16051500|NCT02515045|Drug|Moxifloxacin HCl 0.5%|Antibiotic to be used 1 drop, QID for 3 days prior to surgery and will continue for 2 weeks after surgery and then discontinue.
16051501|NCT02515045|Drug|Ilevro|NSAID to be used 1 drop QD starting 3 days before surgery and QD for 4 weeks after surgery.
16051502|NCT02515045|Drug|Prednisolone acetate 1%|Steroid to be started after surgery 1 drop QID for 2 weeks, tapered to BID for 2 weeks, and then discontinued.
16051503|NCT02515032|Dietary Supplement|Nutrifriend Cachexia|2 daily for 12 weeks
16051504|NCT02515032|Dietary Supplement|Isocaloric placebo|2 daily for 12 weeks
16051505|NCT02515019|Device|Bispectral index Monitoring|In group SevoBIS, the sevoflurane concentration was titrated to maintain a target BIS value between 40 and 60.
16051506|NCT02515006|Other|Homeopathy Medicine|Homeopathy, or homeopathic medicine, is a holistic system of treatment. Individualized homeopathy remedy was based on the most characteristic and clear mental symptoms. Secondly, general symptoms were taken into account.C-potencies were provided and manufactured according to the Homeopathic Pharmacopoeia and Hahnemann's methodology. Each individualized homeopathic remedy were be prescribed in C-potencies
16051507|NCT02514980|Drug|Bupivacaine|Infraorbital nerve block using bupivacaine 0.25% on each side.
16051508|NCT02514980|Drug|Ketamine|Infraorbital nerve block using 0.5mg/kg ketamine on each side.
16051509|NCT02514967|Drug|Blisibimod|Administered via subcutaneous injection once per week
16051510|NCT02514967|Drug|Placebo|Administered via subcutaneous injection once per week
16051511|NCT02514954|Drug|Biochaperone® Combo|Subcutaneous injection of an individualized dose
16051512|NCT02514954|Drug|Humalog® Mix25|Subcutaneous injection of an individualized dose
16051513|NCT02514941|Drug|paracetamol|Administration of 5 ml Paracetamol Saft Hexal (= 200 mg paracetamol)
16051514|NCT02514941|Drug|amoxicillin|Administration of 5 ml Amoxypen® 250 mg Saft (= 250 mg amoxicillin)
16051515|NCT02514941|Drug|talinolol|Administration of 1 tablet Cordanum® 50 (= 50 mg talinolol) dissolved with 40 ml tap water
16051551|NCT02514681|Drug|Vinorelbine|
16051516|NCT02514941|Procedure|gastroduodenoscopy with biopsy|Gastroduodenoscopy with biopsy of the lower duodenum before the first pharmacokinetic study period
16051517|NCT02514941|Procedure|gastrojejunoscopy with biopsy|Gastrojejunoscopy with biopsy of the jejunum about one year after proximal Roux-en-Y gastric bypass
16051518|NCT02514941|Procedure|proximal Roux-en-Y gastric bypass|sampling of a tissue specimen from the jejunum during the operation
16051519|NCT02514928|Procedure|resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy|Resection of the nerve plexus on the right half of celiac and SMA associated with extended pancreatoduodenectomy. Regional lymph nodes includes group 5,6,8a,8p,9,12a,12b,12c,12p,13,14a,14b,14c,16,17, according to the 2003 edition of lymph nodes group system defined by Japan Pancreas Society (JPS).
16051520|NCT02514928|Procedure|standard pancreatoduodenectomy|Standard pancreatoduodenectomy with regional lymph nodes includes group 5,6,8a,12b,12c,13,14a,14b,17, according to the 2003 edition of lymph nodes group system defined by Japan Pancreas Society (JPS).
16051521|NCT02514915|Radiation|Stereotactic Radiosurgery|Radiation therapy
16051522|NCT02514902|Device|Lateral Flow Device|A drop of whole blood from a finger stick is placed on the lateral flow device at two different time points to indicate the presence of a neuronal specific biomarker. The results will also be correlated to severity of clinical and radiographic injury. Separate drops are evaluated similarly for serum levels. The objective is to determine feasibility of a diagnostic tool for stroke (ischemic and hemorrhagic and traumatic brain injury (TBI). No diagnostic results or resulting treatments will be applied to any subject.
16051523|NCT02514889|Behavioral|Calorie-counting|"The Calorie Counting (CC) condition asks obese patients to achieve a daily calorie deficit. For average women consuming 2,000 calories at baseline, the target daily calorie total might be 1,600 calories. Participants are also asked to do at least 150 minutes of moderate to vigorous physical activity per week.
~Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the CC condition. The intervention protocol is adapted from the Diabetes Prevention Program. Behavior change strategies include: self-monitoring (e.g., calorie-counting, self-weighing), stimulus control, and relapse prevention strategies. The health coaching will occur during two home visits, two group health education sessions, and 7 telephone coaching calls."
16051524|NCT02514889|Behavioral|MyPlate|"The MyPlate approach asks Americans to limit daily calories but emphasizes eating MORE high-satiation foods by making ½ of daily food choices fruits and vegetables,¼ of daily food choices whole grains. All participants are asked to do at least 150 minutes of moderate to vigorous physical activity per week.
~Two community health workers will provide behavior change coaching to 150 TCC obese patients randomly assigned to the MyPlate condition. MyPlate is adapted from the DASH protocol. Behavior change strategies include: progressive goal-setting, stimulus control, and self-monitoring (e.g., % of food choices that are fruits & vegetables). The health coaching will occur during two home visits, two group health education sessions, and 7 telephone behavior change coaching calls."
16051525|NCT02514876|Device|Foresight ICE System|The Foresight ICE System is composed of a sterile, single-use catheter intended to operate with a Foresight ICE PIM and Hummingbird Console.
16051526|NCT02514850|Drug|Biochaperone Combo|Injection of BioChaperone Combo
16051527|NCT02514850|Drug|Humalog Mix25|Injection of Humalog Mix25
16051528|NCT02514850|Drug|Humalog|Injection of Humalog
16051529|NCT02514850|Drug|Lantus|Injection of Lantus
16051530|NCT02514850|Drug|Placebo|Injection of saline 0.9% solution
16051531|NCT02514837|Device|RTM|Both the internal temperature and skin temperature will be measured non-invasively through the skin using the RTM device
16051532|NCT02514824|Drug|MLN0128|Investigational mTOR kinase inhibitor
16051533|NCT02514811|Behavioral|The Teen Outreach Program|Students received the Teen Outreach Program as described previously.
16051534|NCT02514798|Other|Esophageal and gastric balloons|Esophageal and gastric pressures will be measured with an esophageal ballon positioned at the lower third of the esophagus, filled with 0.5 mL of air and a gastric balloon filled with 1 mL of air. The proper position of balloons will be verified using the occlusion test as previously described. Transdiaphragmatic pressure (Pdi) is calculated as the difference between gastric (Pga) and esophageal (Pes) pressure. The pressure time integrals of the diaphragm and the other inspiratory muscles are calculated per breath (PTPdi/b and PTPes/b, respectively) and per minute (PTPdi/min and PTPes/min). Measurements will be collected at baseline, at each randomized HFNC and CPAP settings during the last 4 minutes of each 10 minutes session.
16051535|NCT02514798|Other|Respiratory Inductance Plethysmography (RIP) system|Inspiratory tidal volume (VTi), respiratory rate (RR), breath duration (Ttot), inspiratory time (Ti) and fractional inspiratory time (Ti/Ttot) will be determined using a Respiratory Inductive Plethysmography (RIP) system. This will measure the thoracic and abdominal excursion of the subjects via two inductive wires which are sewn into the elastic bands that encircle the thorax and abdomen. The acquired signals represent changes in cross-sectional area and, following calibration to determine the relative contribution of each signal, and volume calibration using spirometry, their weighted sum will reflect VTi. The RIP companion software will be used to derive RR, Ttot, Ti and Ti/Ttot on a breath by breath basis.
16051536|NCT02514798|Other|Sentec transcutaneous monitoring system|The oxygenation, the level of carbon dioxide, and the heart rate will be recorded using the Sentec transcutaneous monitoring system: a probe will be placed at the earlobe or on the forehead, and it will measure in a noninvasive way these parameters.
16051537|NCT02514798|Device|High-flow humidified nasal oxygen delivery system|
16051538|NCT02514798|Device|CPAP (Positive Control)|
16051539|NCT02514772|Biological|GP2013 - A Proposed biosimilar rituximab|
16051540|NCT02514772|Biological|Originator rituximab - Rituxan ® or MabThera ®|
16051541|NCT02514759|Behavioral|The Teen Outreach Program|Students received the Teen Outreach Program as described previously.
16051542|NCT02514746|Biological|Live Attenuated Japanese Encephalitis SA-14-14-2 Vaccine|0.5 mL subcutaneous injection
16051543|NCT02514720|Other|cigarette|Participants will be allowed to smoke a cigarette prior to a PET scan and be abstinent from smoking prior to the other PET scan
16051544|NCT02514694|Drug|LEO32731|
16051545|NCT02514694|Other|Placebo|
16051546|NCT02514681|Drug|Trastuzumab|
16051547|NCT02514681|Drug|Pertuzumab|
16051548|NCT02514681|Drug|Docetaxel|
16051549|NCT02514681|Drug|Paclitaxel|
16051550|NCT02514681|Drug|Nab-paclitaxel|
16051555|NCT02514668|Drug|Isatuximab|"Pharmaceutical form: solution for infusion
~Route of administration: intravenous"
16051556|NCT02514655|Device|Nosten® pressure control (it's not an antibiotic, but simple device)|One experimental group with the control of the cuff pressure by Nosten® device
16051557|NCT02514655|Other|Manual pressure control|One control group with the manual monitoring of the cuff pressure and inflation of the balloon
16051558|NCT02514642|Drug|low-dose ticagrelor|low-dose ticagrelor (22.5 mg twice daily) for 7 days,followed by a 2-week washout period then a 7days crossover phase of clopidogrel (75mg once daily)
16051559|NCT02514642|Drug|Clopidogrel|clopidogrel (75mg once daily) for 7 days,followed by a 2-week washout period then a 7days crossover phase of low-dose ticagrelor (22.5 mg twice daily)
16051560|NCT02514629|Drug|Placebo|
16051561|NCT02514629|Drug|Metformin|
16051562|NCT02514629|Drug|Testosterone Undecanoate|
16051563|NCT02514629|Drug|Metformin + Testosterone Undecanoate|
16051564|NCT02514616|Procedure|Laparoscopic IPG and lead implant procedure|EST placement
16051565|NCT02514616|Device|Active Electric Stimulation Therapy|Device programming by the technician to deliver the EST system active (Treatment group) or no stimulation (Control group) for the following 12 weeks, at the 2 weeks visit.
16051566|NCT02514616|Device|Delayed Electric Stimulation Therapy|Device programming by the technician to deliver the EST system no stimulation for the following 12 weeks at the 2 weeks visit. Active Electric Stimulation Therapy will be programmed at the 14 weeks visit.
16051567|NCT02514603|Drug|Prexasertib|Administered IV
16051568|NCT02514590|Device|Freedom SCS System|This Freedom SCS System is based on wireless neuromodulation technology. This technology includes octapolar stimulators with embedded receivers. The energy source is a small, external, rechargeable transmitter, which is worn by the subject. The device is programmed to have a 5-1500 Hz therapy.
16051569|NCT02514577|Drug|IDP-122 Lotion|Topical lotion
16051570|NCT02514577|Drug|IDP-122 Vehicle Lotion|Topical lotion. No active ingredient.
16051571|NCT02514564|Behavioral|Exercise|Patients included in the study will be enrolled in a cardiac rehabilitation program, in an independent manner of the study protocols.
16051572|NCT02514551|Drug|Ramucirumab|Administered IV
16051573|NCT02514551|Drug|Paclitaxel|Administered IV
16051574|NCT02514538|Drug|Non- effervescent Paracetamol kern|1g
16051575|NCT02514538|Drug|Effervescent paracetamol termalgin|1 g
16051576|NCT02514525|Device|CryoBalloon Ablation System|CryoBalloon Ablation System, a balloon-based cryotherapy device, provides controlled ablation for the treatment of BE. Deployed through the working channel of an endoscope, the Balloon is simultaneously inflated and cooled with an inert cryogen (nitrous oxide) delivered from the handle that ablates the BE cells upon contact with the esophagus.
16051577|NCT02514512|Device|MLC Tracking|Treat patient with Non FDA approved MLC Tracking
16051578|NCT02514499|Other|Questionnaires|
16051579|NCT02514486|Behavioral|Questionnaire|
16051580|NCT02514473|Drug|VX-809|
16051581|NCT02514473|Drug|Placebo|
16051582|NCT02514473|Drug|VX-770|
16051583|NCT02514460|Device|plaque excision system|
16051584|NCT02514460|Device|Stent|
16051585|NCT02514447|Drug|Trilaciclib|
16051586|NCT02514447|Drug|Placebos|
16051587|NCT02514447|Drug|Topotecan|
16051588|NCT02514434|Radiation|Ultrasonography|Subjects will be randomly allocated to either Ultrasonography arm or Non-contrast MRI arm for their surveillance method.
16051589|NCT02514434|Radiation|non-contrast MRI|Subjects will be randomly allocated to either Ultrasonography arm or Non-contrast MRI arm for their surveillance method.
16051590|NCT02514421|Device|Electroporation|Irreversible electroporation (IRE) will be performed under computed tomography (CT) guidance, during which 2 to 6 needles are advanced into the pancreatic tumor where a specified field strength will be applied.
16051591|NCT02514421|Drug|gemcitabine|The chemotherapy schedule will include administration of gemcitabine 1000mg/m2 IV infusion over approximately 30 minutes on days 1, 8, and 15 of each 28 day cycle.
16051592|NCT02514421|Drug|nab-paclitaxel|The chemotherapy schedule will include administration of nab-paclitaxel 125mg/m2 intravenous (IV) over approximately 30 to 45 minutes on Days 1, 8, and 15.
16051593|NCT02514408|Procedure|Catheter Management|Insertion of venous catheter under ultrasound guidance
16051594|NCT02514408|Other|Cytology Specimen Collection Procedure|Collection of blood samples
16051595|NCT02514408|Other|Laboratory Biomarker Analysis|Correlative studies
16051596|NCT02514395|Other|disability index administration -self report form|Final T12 version of KOOS was given to the participants by an assistant who was not involved with any prior procedure. At the same time SF- 36 v2[32] generic health measure was also handed over. Filled forms were collected by the same assistant. Next day participants were given another blank copy of Marathi KOOS T12 versions. Hence each participant filled three forms.
16051597|NCT02514382|Drug|Bortezomib|Given SC or IV
16051598|NCT02514382|Drug|Dexamethasone|Given PO, IV, or IM
16051599|NCT02514382|Other|Laboratory Biomarker Analysis|Correlative studies
16051600|NCT02514382|Other|Pharmacological Study|Correlative studies
16051601|NCT02514382|Biological|Wild-type Reovirus|Given IV
16051602|NCT02514356|Behavioral|Own adherence|In this intervention group, participants receive weekly SMS messages informing them of their adherence that week as measured by the wise pill device used by the participant.
16051603|NCT02514356|Behavioral|Own and group level adherence|In this intervention group, participants receive weekly SMS messages informing them of their adherence that week as measured by the wise pill device used by the participant. In addition, in the same message they are informed of the adherence demonstrated by the other participants
16051604|NCT02514343|Drug|Magnesium Sulfate|1ml of 10% magnesium sulfate with 1.5 ml of sterile water
16051605|NCT02514343|Drug|Bupivacaine|1.5 ml of Bupivacaine 5mg/ml plus 1 ml of 10% magnesium sulfate
16051606|NCT02514330|Other|Interval Training at 1% incline|Six stimuli were performed to exhaustion. The vertical drop jump strategy (height and kinematics) served to establish the magnitude of the concurrent effect
16051607|NCT02514330|Other|Interval Training at 10% incline|Six stimuli were performed to exhaustion. The vertical drop jump strategy (height and kinematics) served to establish the magnitude of the concurrent effect.
16051608|NCT02514317|Procedure|percutaneous treatment|
16051609|NCT02514317|Device|Ultrasound|
16051610|NCT02514291|Behavioral|Sleep intervention|Standard pediatric neurology care plus education and augmented support around adequate sleep habits, appropriate daylight exposure, and beneficial and safe physical activity tailored to each epileptic child's capabilities.
16051611|NCT02514278|Drug|Neoadjuvant chemotherapy Folfirinox, 4 cycles|"oxaliplatin: 85 mg/m2
~irinotecan: 180 mg/m²
~folinic acid: 400 mg/m2 (DL form) or 200 mg/m2 (L form)
~5FU: 2400 mg/m2"
16051612|NCT02514278|Radiation|50 Gy, 2 Gy/session; 25 fractions|Radiochemotherapy 5 weeks
16051613|NCT02514278|Procedure|Local excision in good responders|"If local excision:
~Surveillance if ypT0-1 or ypT2Nx/cN0 (no lymph node at baseline imaging)
~Complementary rectal excision if ypT2Nx/cN1, ypT3 or R1."
16051614|NCT02514278|Procedure|Rectal excision in bad responders|
16051615|NCT02514278|Drug|Capecitabine|1600 mg/m2 daily 5 days/7
16051616|NCT02514252|Drug|Fentanyl Sublingual Spray (FSS)|"Stage 1: First Pain Episode - Single dose of breakthrough opioid given from existing PCA pump equivalent to 10% of their MEDD.
~Second Pain Episode - Single dose of FSS equivalent to 16-32% of MEDD. If not effective at 30 minutes, participant repeats same dose one more time (with a cap of 1600 mcg total; i.e. dose given 30 minutes ago + dose now = 1600 mcg maximum.
~Third Pain Episode (at least 4 hours after second episode) - Participant required 2 breakthrough FSS doses for the last episode of breakthrough pain, or if the effective dose has not been identified, he/she will double the last administered dose. If breakthrough pain not effective at 30 minutes, participant repeats same dose one more time (with a cap of 1600 mcg total; i.e. dose given 30 minutes ago + dose now = 1600 mcg maximum).
~Stage 2: If FSS successful in hospital, upon discharge, FSS used as first choice of pain medication instead of oral pain medication for pain for up to 4 weeks."
16051617|NCT02514252|Behavioral|Questionnaires|Symptom questionnaire completed at baseline and after last dose of FSS while hospitalized. After Day 28, questionnaire completed over the phone about participant's opinion of research study.
16051618|NCT02514252|Behavioral|Mental Ability Tests|Mental ability tests given while hospitalized 30 minutes after first dose of current pain medication, and 30 minutes after each FSS dose.
16051619|NCT02514252|Behavioral|Study Diary|Participants given study diary to document pain level, how many times FSS used, and any side effects experienced each day.
16051620|NCT02514239|Drug|BI 836909|Intravenous Infusion of BI 836909.
16051621|NCT02514226|Procedure|supragingival treatment|In G1, all participants will receive supragingival treatments by an experienced specialist with universal curettes (Hu-Friedy) and ultrasound (Ultra Sound Dabi Atlante - Profi Neo US, Ribeirao Preto, Brazil). Supragingival treatment will be performed above the gingival margin.
16051622|NCT02514226|Procedure|periodontal treatment|All participants receive periodontal treatments by an experienced specialist with universal curettes (Hu-Friedy) and ultrasound (Ultra Sound Dabi Atlante - Profi Neo US, Ribeirao Preto, Brazil) in a full mouth manner.
16051623|NCT02514226|Procedure|periodontal treatment and photodynamic therapy|In G3, the periodontal treatment will be performed identical as G2. PDT will be administered in periodontal pockets > 4mm. Methylene blue will be applied in the deep of periodontal pockets. After 5 minutes of application the red laser diode (λ = 660 nm) will be applied with output power of 100 mW (Therapy XT, DMC, São Carlos, Brazil) with 90 seconds of exposure, i.e. 9J in each point. Applications will be held in six sites around the tooth in all teeth. To finalize, 1 minute of irradiation in scan around each tooth and rinsing with saline solution to remove the FS.
16051624|NCT02514226|Other|dental hygiene orientation|Plaque Control through the use of toothbrush and floss
16051625|NCT02514213|Biological|2mg INO-5150 and electroporation device CELLECTRA®-5P|2mg INO-5150 delivered IM followed by electroporation using CELLECTRA®-5P
16051626|NCT02514213|Biological|8.5mg INO-5150 and electroporation device CELLECTRA®-5P|8.5 mg INO-5150 delivered IM followed by electroporation using CELLECTRA®-5P
16051627|NCT02514213|Biological|2mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P|2mg INO-5150 plus 1 mg INO9012 delivered IM followed by electroporation using CELLECTRA®-5P
16051628|NCT02514213|Biological|8.5mg INO-5150 plus 1mg INO-9012 and electroporation device CELLECTRA®-5P|8.5mg INO-5150 plus 1 mg INO9012 delivered IM followed by electroporation using CELLECTRA®-5P
16051629|NCT02514213|Device|Electroporation using CELLECTRA®-5P|Electroporation device CELLECTRA®-5P
16051630|NCT02514200|Procedure|Topography-based CXL (KXL2)|The keratoconus cornea is treated with epithelial debridement in local anesthesia, and then soaked in Riboflavin by repeated topical application every 3 minutes during 10 minutes. The cornea is then irradiated with pulsed ultraviolet light (1s on/1s off) in a topography-based arcuate shape with the Avedro KXL2® with an energy from 7.2-15.0 J/cm2 depending on the severity of the keratoconus.
16051631|NCT02514200|Procedure|Conventional pulsed CXL (pCXL)|The keratoconus cornea is treated with epithelial debridement in local anesthesia, and then soaked in Riboflavin by repeated topical application every 3 minutes during 10 minutes. The cornea is then irradiated with pulsed ultraviolet light (1s on/1s off) in a central round 8mm zone with the Avedro KXL2® with an energy of 5.4 J/cm2.
16051632|NCT02514200|Drug|Riboflavin|Riboflavin is added topically immediately before the treatment every 3 minutes during 10 minutes in the eye to be treated
16051633|NCT02514200|Device|Avedro KXL II|The KXL II™ System crosslinking device from Avedro, Inc. is used for ultraviolet irradiation of the cornea after riboflavin application in both treatment arms.
16051634|NCT02514187|Drug|Cyclotron-produced 99mTc|"Each research subject will serve as his/her own control, and will undergo imaging using both generator- and cyclotron-produced 99mTc. The study will follow the usual clinical procedure for routine imaging in the nuclear medicine department.
~All subjects will be contacted by phone or in person the day following the injection of both generator and cyclotron-produced 99mTc to monitor for potential adverse events."
16051635|NCT02514187|Drug|Generator-produced 99mTc|"Each research subject will serve as his/her own control, and will undergo imaging using both generator- and cyclotron-produced 99mTc. The study will follow the usual clinical procedure for routine imaging in the nuclear medicine department.
~All subjects will be contacted by phone or in person the day following the injection of both generator and cyclotron-produced 99mTc to monitor for potential adverse events."
16051636|NCT02514174|Drug|Afatinib|afatinib starting at 30 mg daily dose
16051637|NCT02514161|Other|Inspiratory Muscle training|This protocol will be performed using the Powerbreathe classic level 1 device and Yoga Respiratory Exercises (Pranayama)
16051638|NCT02514161|Other|IMT + Manual Therapy and Motor Control Exercise|The Inspiratory Muscle Training protocol will be performed using the Powerbreathe classic level 1 device and Yoga Respiratory Exercises (Pranayama). Manual Therapy and Motor Control Exercises will consist of joint mobilization/manipulation and exercises in the neck and thoracic regions
16051643|NCT02514135|Other|No intervention|
16051644|NCT02514122|Drug|Ketamine|Patients will receive a subcutaneous injection of ketamine (at a dose of 1mg/kg) immediately following surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections.
16051645|NCT02514122|Drug|Saline|Patients will receive a subcutaneous injection of saline (at a dose of 0.02cc/kg) immediately following surgery, the evening after surgery, and every 12 hours thereafter for a total of 5 injections.
16051646|NCT02514109|Other|Neurological assessment and Blood sample|Neurological assessment (physical examination, electroneuromyography , International Prognostic Score (ISS), Overall Disability Scale (ODS)) and 2 blood collection tubes for antibody screening
16051647|NCT02514083|Drug|Ibrutinib|Ibrutinib 420mg PO daily for the duration of the study.
16051648|NCT02514083|Drug|Fludarabine|Fludarabine 25 mg/m2/day IV on days 1-5 of cycles 3 and 4
16051649|NCT02514070|Drug|EPA-rich fish oil|4 gel capsules, 3 times/day for 6 weeks
16051650|NCT02514070|Drug|DHA-rich fish oil|4 gel capsules, 3 times/day for 6 weeks
16051651|NCT02514057|Other|Questionnaire|Form filling only
16051652|NCT02514044|Drug|Dexedrine|10 mg immediate release of Dexedrine
16051653|NCT02514044|Device|Active tDCS|1.5 mA tDCS anodal tDCS
16051654|NCT02514044|Behavioral|Speech Therapy|60 min of speech therapy
16051655|NCT02514044|Drug|Placebo|
16051656|NCT02514044|Device|Sham tDCS|
16051657|NCT02514031|Drug|ARQ-761|"Dose Level 1:
~ARQ761 195 mg IV D1, D15 Gemcitabine 1000 mg/m2 D1, 8, 15 Nab paclitaxel 125 mg/m2 D1, 8, 15
~Dose Level 2:
~ARQ761 290 mg IV D1, D15 Gemcitabine 1000 mg/m2 D1,8,15
~Dose Level 3:
~ARQ761 390 mg IV D1, D15 Gemcitabine 1000 mg/m2 D1,8,15 Nab-paclitaxel 125 mg/m2 D1,8,15
~Expansion Dose Level:
~ARQ761 390 IV mg or as tolerated D1, 15 Gemcitabine 1000 mg/m2 D1,8,15 Nab-Paclitaxel 125 mg/m2 D1,8,15"
16051658|NCT02514031|Drug|Gemcitabine|"Therapy after lead in Phase:
~You will receive Gemcitabine (1000mg/m2) administered intravenously on Days 1,8, 15-every 28 days. All cycles are 28 days in duration and there are no rest periods between cycles. You may continue treatment after cycle 6 until disease progression."
16051659|NCT02514031|Drug|nab-paclitaxel|"Therapy after lead in phase:
~You will receive nab-paclitaxel (125 mg/m2) administered intravenously on Days 1,8, 15-every 28 days. All cycles are 28 days in duration and there are no rest periods between cycles. You may continue treatment after cycle 6 until disease progression."
16051660|NCT02514018|Biological|Live-attenuated varicella-zoster virus vaccine|Commercial vaccine used to prevent shingles
16051661|NCT02514005|Other|Manual therapy|- Manual Therapy. Study treatment consists of a comprehensive joint treatment of the lumbar region and the lower limbs that are related to the biomechanics of the knee. In this way, the aim is to globally balance the possible dysfunctions that may exist in the lower lumbar region and sacroiliac joint, hip, knee and ankle.
16051662|NCT02514005|Device|Dry needling|"Manual therapy. Study treatment consists of a comprehensive joint treatment of the lumbar region and the lower limbs that are related to the biomechanics of the knee. In this way, the aim is to globally balance the possible dysfunctions that may exist in the lower lumbar region and sacroiliac joint, hip, knee and ankle.
~Dry needling (DN). Dry needling is performed in the MTrPs of the vastus lateralis and vastus medialis muscles of the quadriceps."
16051663|NCT02513992|Procedure|intra-arterial injection of tracer|intra-arterial ictal injection of perfusion tracer
16051664|NCT02513992|Drug|99m-Technetium Ethyl Cysteinate Dimer|administration of perfusion tracer 99m Tc-ECD during epileptic seizure
16051665|NCT02513992|Device|intra-arterial catheter|placement of intra-arterial catheter via femoral artery
16051666|NCT02513992|Device|pressure injector|the injection of the perfusion tracer will be delivered with a pressure injector
16051667|NCT02513979|Drug|Angiotensin type II receptor antagonists|Angiotensin type II receptor antagonists given to hypertensive patients treated with high blood pressure
16051668|NCT02513953|Procedure|Laparoscopic|Four Port Laparoscopic cystectomy
16051669|NCT02513940|Drug|Testosterone|Subjects will receive transdermal testosterone gel 1% 100 mg daily for 7 days
16051670|NCT02513940|Drug|Progesterone|Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days
16051671|NCT02513940|Drug|Placebo|Subjects will receive placebo transdermal gel and placebo (lactose) capsules
16051672|NCT02513940|Drug|Ibutilide|Ibutilide 0.003 mg/kg administered to all subjects in all phases to moderately lengthen the QT interval
16051673|NCT02513927|Drug|metoprolol|Metoprolol was given orally in a dose of 95 mg/day to treat patients in the metoprolol group for 12 weeks.
16051674|NCT02513927|Drug|Nifedipine|Nifedipine was given orally in a dose of 30 mg/day to treat patients in the amlodipine group for 12 weeks.
16051675|NCT02513914|Device|Dural Venous Sinus Stenting|See Dural Venous Sinus Stenting arm.
16051676|NCT02513914|Device|Cerebrospinal Fluid Shunting|See Cerebrospinal Fluid Shunting arm.
16051677|NCT02513901|Drug|Chidamide|Chidamide will be given by mouth on Day 0, 3, 7, 10, 14, 17, 21, 24.
16051678|NCT02513888|Dietary Supplement|vitamin D + diet and lifestyle|subjects will be given vitamin D along with diet and lifestyle modification counselling
16051679|NCT02513888|Dietary Supplement|Placebo + diet and lifestyle|placebo along with diet and lifestyle modification counselling
16051680|NCT02513875|Dietary Supplement|vitamin D|60,000 IU per week for 8 weeks
16051681|NCT02513875|Dietary Supplement|Placebo|placebo +diet and lifestyle
16051682|NCT02513862|Device|Autologous Platelet-Rich Plasma Harvest Technique|15 to 20 mL/kg of whole blood is collected before the administration of heparin from a large-bore central venous access,and is separated into red blood cells component and autologous platelet-rich plasma component by an autologous transfusion system(Sorin Group Electa Essential; Sorin Group Italia, Milan, Italy).
16051683|NCT02513849|Drug|Tamoxifen|Daily tamoxifen tablet for approximately 4 weeks
16051684|NCT02513836|Other|Pre-education intervention|All study participants will be tested with a questionnaire (POEM; Patient Opioids Education Measurement) on their opioid knowledge during 1st visit at the pain clinic.
16051685|NCT02513836|Other|Post-education intervention|All study participants will be educated on opioids via an education sheet, pamphlet and video from the Institute for Safe Medication Practices (ISMP) Canada. The questionnaire (POEM) will be tested again after this education on opioid knowledge on the same day.
16051686|NCT02513823|Dietary Supplement|2,000 International Units (IU)of vitamin D3|2,000 IU vitamin D taken daily for 10 weeks
16051687|NCT02513810|Device|BioFreedom with 1 month DAPT|The cath lab will follow site standard operating procedures for PTCA and stenting. Information will be collected and recorded on the treated study vessel including angiographic parameters. Dual antiplatelet therapy after PCI will be continued for 1 month.
16051688|NCT02513810|Device|BioMatrix or Ultimaster with 6 to 12 months DAPT|The cath lab will follow site standard operating procedures for PTCA and stenting. Information will be collected and recorded on the treated study vessel including angiographic parameters. Dual antiplatelet therapy after PCI will be the duration of dual antiplatelet therapy will be 6 to 12 months at the discretion of the interventionist.
16051689|NCT02513797|Device|LARIAT + PVI|Left Atrial Appendage ligation with the LARIAT System initially performed followed by adjunctive pulmonary vein isolation catheter ablation in staged procedures
16051690|NCT02513797|Device|Pulmonary Vein Isolation|Perform pulmonary vein isolation (PVI) catheter ablation procedure using a contact force sensing, irrigated radiofrequency catheter approved by FDA for the treatment of atrial fibrillation.
16051691|NCT02513784|Drug|Chlorhexidine gluconate|Chlorhexidine gluconate is a germicidal mouthwash that reduces bacteria in the mouth.
16051692|NCT02513771|Drug|Sitagliptin|100 mg one tablet taken orally daily for 16 weeks, followed by a 4-week post-treatment follow-up
16051693|NCT02513771|Drug|Placebo for sitagliptin|One tablet taken orally daily for 16 weeks, followed by a 4-week post-treatment follow-up.
16051694|NCT02513758|Other|sample|Men will have blood sampling tubes of 10 ml each, a saliva sample and a sample of sperm Women will have a two blood sampling tubes of 10 ml each, a saliva sample and a sampling cervicovaginal secretions
16051695|NCT02513745|Device|Conventional|Routine cataract surgery by phacoemulsification before laser-assisted cataract surgery.
16051696|NCT02513745|Device|Refractive Cataract Suite (Verion + ORA)|Laser-assisted cataract surgery with the digital surgical planning and positioning tools, and intraoperative aberrometry.
16051697|NCT02513732|Device|XIENCE Xpedition 2.25 mm stent|Patients receiving XIENCE Xpedition 2.25 mm stent
16051698|NCT02513719|Device|XIENCE PRIME SV Everolimus Eluting Coronary Stent|Patients receiving XIENCE PRIME SV Everolimus Eluting Stent
16051699|NCT02513693|Drug|Standard neuromuscular blockade|Standard neuromuscular block provided by rocuronium to TOF-count 1-2. Reversal of the block with neostigmine.
16051700|NCT02513693|Drug|Deep neuromuscular blockade|Deep neuromuscular block provided by rocuronium to PTC 1-2. Reversal of the block with sugammadex.
16051701|NCT02513680|Device|Infrared Laser + Amber LED|This group will make the application on the machine program that uses laser and led together to photorejuvenation . Laser is applied for 30 seconds and soon after begins the LED by 2:30 minutes in each region to apply.
16051702|NCT02513680|Device|Amber LED|This group will make the application on the machine program that uses LED photorejuvenation only 3 minutes of time for each area to be applied.
16051703|NCT02513667|Drug|Ceritinib|Patients will receive ceritinib at a dose of 750 mg (150 mg capsules times 5 capsules once a day) for 10 weeks. Patient will stop taking Ceritinib 72 hours before SABR radiation. The patient may start taking Ceritinib again 72 hours after radiation is complete. Patient will continue to take certinib for up to 8 months.
16051704|NCT02513667|Radiation|Stereotactic ablative body radiation|Patients will receive study drug for 10 weeks. They could get 1, 3 ,or 5 treatments on consecutive days with 18 hours between each treatment or every other day (doctor's determination).
16051705|NCT02513654|Drug|Lamotrigine|Lamotrigine dispersible tablets supplied in 3 different strengths 25 mg, 50 mg and 100 mg. These dispersible tablets appear as white or off-white tablets.
16051706|NCT02513641|Device|Hypoxico Altitude Training Systems|Participants will sleep in a tent (which will fit his/her personal mattress) simulating an altitude of ~2,400 meters for 7-12 hours each night for a period of 14 days. Baseline testing measures will include a oral glucose tolerance test (OGTT) and body composition (iDXA). Post-treatment testing measures will include OGTT only.
16051707|NCT02513602|Procedure|Dental implant insertion|Dental implant insertion will be carry out in the mandible of the patients enrolled, through a surgical template in order to repeat the same position of the simulating implant insertion. After a trephine bur passage, the final two or three twist-drills will be used to realize the implant socket. After implant positioning, a cover screw will be tightened and the mucosa sutured above.
16051708|NCT02513589|Drug|18F-PBR06|Positron Emission Tomography / Computed Tomography (PET-CT) using 18F-PBR06
16051709|NCT02513576|Other|physiotherapy exercises|Consisted of trunk stabilization exercises.The exercises were undertaken for 15 minutes every day for tree weeks. Patients were the contract their abdominal muscles with an emphasis on the transverse abdominal. Patients were to contract their abdominal muscles in a supine,sitting and stand up position.
16051710|NCT02513563|Drug|Carboplatin|Participants will be treated with carboplatin (area under the curve 5 (AUC5) will be used to determine the dosage) twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
16051711|NCT02513563|Drug|Paclitaxel|Participants will be treated with paclitaxel 175 mg/m^2 twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
16051712|NCT02513563|Drug|AZD1775|Participants will receive AZD1775 225 mg twice daily, days 1 and 2 and once a day on day 3 (5 doses) during each 21 day cycle of treatment.
16051713|NCT02513550|Drug|Ixekizumab|Administered SQ
16051714|NCT02513550|Drug|Placebo|Administered SQ
16051715|NCT02513524|Procedure|Direct Observed Therapy test|There is one group only, all of whom will undergo direct observed therapy testing
16051716|NCT02513511|Procedure|laryngoscopy under hypnosis|patient will be put in an hypnotic state before performing a laryngoscopy followed by oro-tracheal intubation
16051717|NCT02513498|Drug|Ixazomib Citrate|Given PO
16051718|NCT02513498|Other|Laboratory Biomarker Analysis|Correlative studies
16051719|NCT02513498|Other|Quality-of-Life Assessment|Ancillary studies
16051720|NCT02513498|Other|Questionnaire Administration|Ancillary studies
16051721|NCT02513485|Drug|Levodopa+carbidopa|Sinemet is a combination of 250 mg levodopa and 50 mg carbidopa. Sinemet will be administered orally at Visit 1 or Visit 2.
16051722|NCT02513485|Drug|Placebo|A placebo is a sugar pill that has no therapeutic effect and will be administered orally at Visit 1 or Visit 2.
16051723|NCT02513472|Drug|Eribulin Mesylate|Eribulin Mesylate will be administered as a 1.4 milligram per square meter (mg/m^2) IV (intravenous) infusion on Day 1 and Day 8 of each 21-day cycle in the presence of clinical benefit until intercurrent illness, unacceptable toxicity, or disease progression occurs, or until the participant withdraws consent.
16051724|NCT02513472|Drug|Pembrolizumab|Pembrolizumab will be administered as a 200 milligram (mg) IV infusion on Day 1 of each 21-day cycle in the presence of clinical benefit until intercurrent illness, unacceptable toxicity, or disease progression occurs, or until the participant withdraws consent.
16051725|NCT02513459|Drug|Risankizumab 600 mg IV|Re-induction treatment; 3 infusions every 4 weeks, after which eligibility was assessed if clinical response was re-gained
16051726|NCT02513459|Drug|Risankizumab 180 mg SC|Maintenance treatment every 8 weeks (q8w) from Visit 2 through the end of trial (EOT) visit. Participants who re-gained their clinical response following the re-induction treatment could continue with maintenance treatment beginning at Visit 5.
16051727|NCT02513446|Drug|BI 1026706|Single dose of BI 1026706 on Day 1
16051728|NCT02513446|Drug|Itraconazole|7 days of itraconazole treatment combined with a single dose of BI 1026706 on the fourth day
16051729|NCT02513433|Drug|Bupivacaine|Local anesthetic
16051730|NCT02513433|Drug|Levobupivacaine|Local anesthetic
16051731|NCT02513433|Drug|Ropivacaine|Local anesthetic
16051732|NCT02513420|Behavioral|Perineal muscle training|It is a combination of perineal massage and Kegel exercises.
16051733|NCT02513407|Behavioral|Behavioral Dietary Intervention|Attend healthy nutritional education session
16051734|NCT02513407|Other|Educational Intervention|Attend EML educational session
16051735|NCT02513407|Behavioral|Exercise Intervention|Attend exercise educational session
16051736|NCT02513407|Behavioral|Exercise Intervention|Receive fitness tracker
16051737|NCT02513407|Other|Laboratory Biomarker Analysis|Correlative studies
16051738|NCT02513407|Other|Questionnaire Administration|Ancillary studies
16051739|NCT02513394|Drug|Palbociclib|
16051740|NCT02513394|Drug|Standard Adjuvant Endocrine Therapy|
16051741|NCT02513381|Other|Vitamin D3, 3200IU|Each participant will receive either Vitamin D3, 3200IU or Placebo daily for three months.
16051742|NCT02513381|Other|Placebo|Each participant will receive either Vitamin D3, 3200IU or Placebo daily for three months.
16051743|NCT02513368|Device|augmentation procedure with Bio-Oss® and Bio-Gide®|soft tissue management using GBR procedure
16051744|NCT02513368|Procedure|augmentation procedure with connective tissue graft|soft tissue management using the bilaminar technique
16051745|NCT02513355|Biological|Endostar|Endostar 15mg/m2, 21 days per cycle, 4 to 6 cycles
16051746|NCT02513355|Drug|Changchun marina|25mg/m2,d1 and d8,q21d×4
16051747|NCT02513355|Drug|cisplatin|80mg/m2,d1, q21d×4
16051748|NCT02513355|Drug|Taxol|135-175mg/m2,d1,q21d×4
16051749|NCT02513355|Drug|parapl|AUC=5-6,d1,q21d×4
16051750|NCT02513342|Biological|Endostar|Endostar 30mg continuous intravenous injection pump,d1-d7；
16051751|NCT02513342|Drug|Docetaxel|d4 Docetaxel，75（mg/m2），iv；
16051752|NCT02513342|Drug|Cisplatin|d4，cisplatin，75（mg/m2），iv；
16051753|NCT02513329|Drug|Bupivicaine|A computer-generated 1:1 block randomization scheme will be used to assign participants to receive bupivacaine. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card.
16051754|NCT02513329|Drug|Saline|A computer-generated 1:1 block randomization scheme will be used to assign participants to receive saline. Randomization will be performed by the injectionist immediately before the injection procedure by opening an opaque envelope to reveal the participant number and group assignment printed on an index card.
16051755|NCT02513303|Drug|Sirolimus|A single dose of sirolimus delivered locally
16051756|NCT02513303|Procedure|AV Fistula Surgery|AV Fistula Surgery
16051757|NCT02513303|Device|Sirolimus-eluting Collagen Implant (SeCI)|SeCI placed at and around the site of the anastomosis of an AV fistula, immediately following completion of a successful AV fistula surgery.
16051758|NCT02513290|Drug|Bilastine|
16051759|NCT02513290|Drug|Loratadine|
16051760|NCT02513251|Other|Chronic pain|Chronic pain patients would complete the Traditional Chinese-Cantonese version of Short Form McGill Pain Questionnaire
16051761|NCT02513238|Drug|Mesenchymal stem cell|Stemcells injected into submandibularis
16051762|NCT02513238|Drug|Isotonic NaCl|
16051763|NCT02513225|Behavioral|Project EMPWR|Participants will receive both Adapted Project EMPWR and Optimized Standard Care (OSC).
16051764|NCT02513225|Other|Optimized Standard Care (OSC)|Participants will receive Optimized Standard Care (OSC) alone.
16051765|NCT02513212|Device|Potassium Oxalate|Professionally applied liquid
16051766|NCT02513212|Drug|Stannous fluoride paste|SnF2 Paste
16051767|NCT02513212|Device|Manual toothbrush|Marketed manual toothbrush
16051768|NCT02513212|Device|Power toothbrush|Marketed power toothbrush
16051852|NCT02512627|Behavioral|Cognitive training|visuospatial, attention, memory, and executive abilities
16051769|NCT02513199|Radiation|SBRT|Radiation is to be delivered to 30-45 Gy in 5 fractions. 40 Gy in 5 fractions will be utilized, unless dose constraints preclude it. Treatment will optimally be delivered every other day with no more than 3 fractions per week. The ideal treatment team will be less than 15 total days.
16051770|NCT02513199|Drug|TACE|two sessions of standard TACE with ethiodol separated by a 4-week interval.
16051776|NCT02513160|Drug|Beclomethasone Dipropionate 640|Beclomethasone Dipropionate 640 mcg BAI
16051777|NCT02513160|Drug|Placebo|"Placebo, taken in the morning and evening each day, was provided in matching BAI and MDI devices.
~The placebo devices were identical to the devices used to deliver active drug."
16051778|NCT02513160|Drug|Beclomethasone dipropionate via 320 mcg BAI|Beclomethasone dipropionate treatment administered via breath-actuated inhaler (BAI) (320 mcg/day).
16051779|NCT02513160|Drug|albuterol/salbutamol|Each patient's current rescue medication was replaced with study-supplied albuterol/salbutamol hydrofluoroalkane (HFA) metered-dose inhaler (MDI) (90 mcg ex-actuator) or equivalent during the run-in and double-blind study periods.
16051780|NCT02513160|Drug|Beclomethasone dipropionate via 320 mcg MDI|Beclomethasone dipropionate treatment administered via metered-dose inhaler (MDI) (320 mcg/day).
16051781|NCT02513147|Drug|Dolutegravir|
16051782|NCT02513147|Drug|PI|(Fosamprenavir, atazanavir, lopinavir or darunavir) boosted with 100 mg of ritonavir, or atazanavir (400 mg / d) not boosted with ritonavir,if the 2 NRTIs are abacavir + Lamivudine
16051783|NCT02513147|Drug|2 NRTI|
16051784|NCT02513147|Drug|2 NRTI|
16051785|NCT02513121|Other|Dietary modification|The intervention is a modification of the family's habitual diet with a low sugar version of their diet.
16051786|NCT02513108|Procedure|same day discharge|same day discharge after PCI for stable CAD
16051787|NCT02513095|Drug|Dantrolene sodium for injectable suspension|Ryanodex will be administered as a rapid IV push as a single doses of 2 mg/kg or as 1 mg/kg.
16051788|NCT02513082|Procedure|Sono guided nerve block|Sono guided nerve block is effectively and safely performed for pain relief after total knee arthroplasty
16051789|NCT02513069|Other|Nicotine gum|"Participants will be prescribed one form of nicotine replacement rescue treatment (i.e., gum, lozenge), and may choose nicotine gum as the preferred rescue treatment. Participants will be instructed to use the rescue method as needed during the post-quit phase of the study to reduce cigarette cravings."
16051790|NCT02513069|Behavioral|mobile contingency management|Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence. Participants are asked to upload these videos to the study's secured server, and are provided reinforcement for videos that suggest smoking abstinence.
16051791|NCT02513069|Behavioral|Telephone counseling|Participants receive five sessions of cognitive-behavioral telephone counseling, and a participant manual. The telephone counseling protocol included in this application is based on standard cognitive-behavioral therapy techniques shown to be efficacious for smoking cessation and is informed by behavioral treatment principles .
16051792|NCT02513069|Other|Nicotine patch|Participants will be prescribed nicotine patches to be used during the post-quit phase of the study.
16051793|NCT02513069|Other|Nicotine lozenge|"Participants will be prescribed one form of nicotine replacement rescue treatment (i.e., gum, lozenge), and may choose nicotine lozenge as the preferred rescue treatment. Participants will be instructed to use the rescue method as needed during the post-quit phase of the study to reduce cigarette cravings."
16051794|NCT02513069|Other|Smart phone|Participants in the experimental condition will be loaned a smart phone to use during the mobile contingency management intervention period. The phone will be used to record videos of carbon monoxide readings to determine smoking abstinence.
16051795|NCT02513069|Other|Carbon monoxide monitor|Participants in the experimental condition will be loaned a CO monitor to use during the mobile contingency management intervention period. The monitor will be used to determine carbon monoxide content in the breath as a measurement of smoking.
16051796|NCT02513056|Other|MRI|MRI
16051797|NCT02513043|Drug|medical abortion|medical abortion
16051798|NCT02513030|Procedure|Defibrillation testing during ICD replacement|
16051799|NCT02513017|Behavioral|Stimulus Control Instructions and Sleep Restriction Therapy|Please refer to arm/group descriptions.
16051800|NCT02513004|Drug|Ticagrelor|Patients will receive first dose of 90mg ticagrelor tablets (powdered) taken via nasogastric tube after LIMA-LAD bypass establishing, the close of thorax and before PCI procedure, followed by 90mg of ticagrelor 12 hours after the first dose. The third dose of ticagrelor will be given to patients after the 24 hour blood sample has been obtained and 24 hours after the first dose. Thereafter, the patients will take 90mg of ticagrelor orally bid, at approximately 12-hourly intervals. The total study period is 3 months.
16051801|NCT02513004|Drug|Clopidogrel|Patients will receive a loading dose of 300mg clopidogrel tablets (four 75mg capsules powdered) taken via nasogastric tube after LIMA-LAD bypass establishing, the close of thorax and before PCI procedure. The second dose of clopidogrel will be given to patients after the 24 hour blood sample has been obtained and 24 hours after the first dose. Thereafter, the patients will take 75mg of clopidogrel capsules orally od. The total study period is 3 months.
16051802|NCT02512991|Other|Helicopter Emergency Medical Service|May 1st 2010, the first Danish Helicopter Emergency Medical System (HEMS) was implemented in Region Zealand and the Capital Region of Denmark.
16051803|NCT02512978|Drug|Levothyroxine|Levothyroxine is used to normalize the thyroid hormone level of patients allocated to levothyroxine.
16051804|NCT02512965|Radiation|20 Gy in 5 fractions|
16051805|NCT02512965|Radiation|Conventional SBRT: 24 Gy in 2 fractions|
16051806|NCT02512952|Procedure|Open flap debridement (OFD)|Oral prophylaxis followed by Open flap debridement (OFD)
16051853|NCT02512627|Behavioral|Physical exercise|endurance, balance, and mobility
16051807|NCT02512952|Procedure|OFD with Platelet rich fibrin (PRF)|Oral prophylaxis followed by Open flap debridement (OFD) with Platelet rich fibrin (PRF) placement into the bone defect
16051808|NCT02512952|Procedure|OFD with Titanium Platelet rich fibrin (TPRF)|Oral prophylaxis followed by Open flap debridement (OFD) with Titanium Platelet rich fibrin (TPRF) placement into the bone defect
16051809|NCT02512939|Procedure|blood test, not yet marketed, no trade name|blood test using the new TB diagnostic test
16051810|NCT02512926|Drug|Carfilzomib|Carfilzomib in combination with cyclophosphamide and etoposide for children with relapsed and refractory solid tumors and leukemias
16051811|NCT02512926|Drug|Cyclophosphamide|
16051812|NCT02512926|Drug|Etoposide|
16051813|NCT02512913|Behavioral|Adapted/enhanced MAPS|The plan is for recruitment at the first prenatal care visit followed by a proposed eight-session phone counseling sequence for the women, consistent with the session frequency in the original MAPS intervention: 1st call at 14 weeks gestation (75% of Romanian women begin prenatal care in 1st trimester), three monthly calls through the 2nd trimester (18-22-26 weeks gestation), a 5th and 6th calls in the 3rd trimester (32 and 36 weeks), and two postnatal calls (2 and 6 weeks postpartum). Four calls are planned for the partners: at 14-, 22-, and 32-weeks, and at 2-weeks postpartum.
16051814|NCT02512900|Drug|MEDI9929, 140 mg|On Day 1, two MEDI9929 subcutaneous injection of 70 mg each were given into the anterior aspect of one thigh immediately followed by the second injection into the anterior aspect of the contralateral thigh to make the required dose of 140 mg in participants of 12 to 17 years of age.
16051815|NCT02512887|Drug|Caudal Block Anesthesia|Anesthesia will be delivered via inhalation induction with air/nitrous oxide and sevoflurane, and injection of 0.25% bupivacaine 1mL/kg without epinephrine into the caudal canal, which is the sacral portion of the spinal canal.
16051816|NCT02512887|Drug|Dorsal Penile Block Anesthesia|Anesthesia will be delivered via inhalation induction with air/nitrous oxide and sevoflurane, and injection of 0.25% bupivacaine without epinephrine into the dorsal portion of the penis.
16051817|NCT02512874|Other|Pulmonary Rehabilitation|Measures of frailty taken before and after pulmonary rehabilitation.
16051818|NCT02512874|Device|Dynamometer|Grip Test
16051819|NCT02512874|Radiation|DEXA|Body Composition Testing
16051820|NCT02512874|Other|Gait Speed Test|15 foot walk test
16051821|NCT02512874|Device|Activity Monitor|Measures energy expenditure and activity
16051822|NCT02512874|Other|Questionnaires|Health-related questionnaires measuring self-reported exhaustion, emotions and disease symptoms.
16051823|NCT02512861|Drug|Bupivacaine|"Bupivacaine will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:
~Under 20kgs weight: 0.25% Bupivacaine at 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5% Bupivacaine at 0.5 ml/kg up to a maximum of 25ml of 0.5% Bupivacaine for patients > 50 kgs"
16051824|NCT02512861|Drug|Placebo|"Saline will be administered bilaterally to the parasternal intercostal spaces during surgery according to these doses:
~Under 20kgs weight: 1 milliliter/kilogram (1ml/kg); Above 20kgs weight: 0.5 ml/kg up to a maximum of 25ml for patients > 50 kgs"
16051825|NCT02512835|Other|Community vital signs|We will present clinicians with information about their patients' communities
16051826|NCT02512822|Procedure|Noninvasive Radiofrequency TruSculpt|Heating subcutaneous fat up to 45℃ continuously at least 3 minutes without surface damage and induces adipocytes apoptosis.
16051827|NCT02512809|Drug|Isoflurane|
16051828|NCT02512809|Drug|Dexmedetomidine|
16051829|NCT02512796|Drug|Gadolinium contrast dye|Gadolinium contrast dye administered during MRI
16051830|NCT02512783|Drug|Lidocaine|Administration of 1ml of pre-treatment 1% lidocaine 1-minute prior to sedation
16051831|NCT02512783|Drug|Normal Saline|Administration of 1ml of pre-treatment normal saline 1-minute prior to sedation
16051832|NCT02512783|Drug|Propofol|Intravenous administration of propofol according to standard care to sedate patient.
16051833|NCT02512770|Procedure|endoscopic dilatation|
16051834|NCT02512744|Procedure|Decannulation protocol.|Comparison of two different decannulation protocols: one protocol based on capping trial tolerance to decide when to decannulate vs. protocol based on suctioning frequency of respiratory secretions to decide when to decannulate (criteria: ≤2 aspirations every 8 h along 24 consecutive hours).
16051835|NCT02512744|Device|High flow conditioned oxygen therapy|High flow conditioned oxygen therapy will be applied during all study period through tracheal cannula in the experimental arm (suctioning frequency based protocol) and during periods out of capping trials in the control arm (capping trials based protocol).
16051836|NCT02512731|Device|Esophageal Doppler Monitor|Esophageal doppler monitoring (EDM) is a minimally invasive means of continuously measuring the cardiac output from the pattern of blood flow in the descending thoracic aorta.
16051837|NCT02512718|Drug|Omegaven|Comparison of FOLE vs. SOLE
16051838|NCT02512718|Drug|Soybean oil lipid emulsion|Comparison of FOLE vs. SOLE
16051839|NCT02512705|Device|Pinel Restraints|
16051840|NCT02512705|Behavioral|Seclusion Room|
16051841|NCT02512692|Device|SIR-Spheres microspheres (Yttrium-90 Microspheres)|On Day 3 or 4 of cycle 1 90Y TARE will be administered
16051842|NCT02512692|Drug|Gemcitabine|On days 1 and 8 of each cycle (21 days) Gemcitabine will be administered. Treatment may last up to 8 cycles
16051843|NCT02512692|Drug|Cisplatin|On days 1 and 8 of each cycle (21 days) Cisplatin will be administered. Treatment may last up to 8 cycles
16051844|NCT02512679|Drug|Cyclophosphamide Dose Level 1|given by IV at a total dose of 105 mg/kg, to be divided into three doses of one 35 mg/kg dose per day, for 3 days on the first level. After ten patients the de-escalation will begin if the stopping rule is not met.
16051845|NCT02512679|Drug|Cyclophosphamide Dose Level 2|Level 2 will be 70mg/kg in 2 divided given once a day for 2 days;
16051846|NCT02512679|Drug|Cyclophosphamide Dose Level 3|Level 3 will be 35mg/kg as a one-time dose.
16051847|NCT02512679|Drug|Cyclophosphamide Dose Level 4|Level 4 will be no cytoxan.
16051848|NCT02512666|Device|AM4113-N5UT Dino-Lite|
16051849|NCT02512653|Biological|Cupressus arizonica|Four different concentrations of Cupressus arizonica allergen extract, positive control and negative control
16051850|NCT02512640|Procedure|Volume-controlled ventilation|a tidal volume of 8 ml/kg
16051851|NCT02512640|Procedure|Pressure-controlled ventilation|a peak airway pressure to maintain a tidal volume of 8 ml/kg
16051854|NCT02512614|Other|Antimicrobial Hand Towel|Novel antimicrobial hand towel.
16051855|NCT02512601|Drug|Sulodexide|Sulodexide (two capsules of Sulodexide 15 mg twice daily).
16051856|NCT02512601|Other|Compression therapy|"Compression:
~With an orthosis: Compression 22-29 mmHg, length of 20 cm above the DVT area.
~With a bandage: 7-10 m long and 10 cm wide.
~Both strategies (orthosis vs bandage) are equally applicable."
16051857|NCT02512588|Drug|BTD-001|
16051858|NCT02512588|Drug|Placebo|
16051859|NCT02512575|Drug|AZD9567 Monohydrat|AZD9567 oral suspension 0.5 to 10 mg/ml
16051860|NCT02512575|Drug|Placebo oral suspension/ Placebo capsule|Matching placebo
16051861|NCT02512575|Drug|Prednisolone|Prednisolone 60mg oral capsules (12 capsules of 5 mg each).
16051862|NCT02512562|Drug|AL-335|AL-335 is a prodrug being developed as an orally administered anti-HCV therapeutic.
16051863|NCT02512562|Drug|ACH-3102|ACH-3102 is an NS5A inhibitor being developed as an orally administered anti-HCV therapeutic.
16051864|NCT02512562|Drug|Simeprevir|Simeprevir is an orally active, small molecule inhibitor of the NS3/4A protease of HCV and indicated for the treatment of chronic HCV infection as a component of a combination antiviral treatment regimen.
16051865|NCT02512549|Other|Pulmonary Rehabilitation|
16051866|NCT02512536|Drug|Botulinum Toxin Type A|Ultrasound scan guided injection into supraspinatus muscle belly with Botulinum Toxin Type A
16051867|NCT02512523|Drug|Teneligliptin|
16051868|NCT02512523|Drug|Sitagliptin|
16051869|NCT02512510|Drug|TD-4208|
16051870|NCT02512510|Drug|Placebo|
16051871|NCT02512497|Drug|Romidepsin|"Part 1: Romidepsin dosed per actual body weight/actual body surface area. Romidepsin administered on Day -6, -5, -4, and -3 at escalating doses of 1 mg/m2, 2 mg/m2, and 3 mg/m2 by vein to determine the maximal tolerated dose.
~Romidepsin Maintenance Therapy - Part 2: Starting between Day +28 and Day +100, if participant is eligible based on disease status, they will continue to receive Romidepsin 8 mg/m2 by vein over 1 hour on Day 1 of each 2-week cycle."
16051872|NCT02512497|Drug|Busulfan|Part 1: First 2 doses of Busulfan of 80 mg/m2 administered on day -13 and -12. Busulfan administered at the dose calculated to achieve a total (including first two doses delivered on Day -13 and -12) systemic exposure of 20,000 ± 12% µMol-min based on the pharmacokinetic (PK) studies. An additional standard of care (SOC) option is now added for those with an HCT-CI >4 or deemed unfit by the investigator to receive full dose (AUC 5000 umol-min) Time-Sequential (TS) Busulfan. SOC busulfan is administered per OSU SCT SOP with a targeted AUC of 4000 umol-min/day for a total exposure of 16,000 umol-min +/- 12% u-Mol-min based upon PK studies. Busulfan 'test-dose' PK studies will be performed prior to administration of full dose of busulfan per SOC. Romidepsin and fludarabine will be administered in an identical fashion using the SOC busulfan as with the TS busulfan. TS busulfan method of busulfan administration will be the preferred method of conditioning therapy for patients enrolled.
16051873|NCT02512497|Drug|Fludarabine|Part 1: Fludarabine 40 mg/m2 by vein on Days -6 to -3.
16051874|NCT02512497|Procedure|Stem Cell Transplant|Stem cell infusion on Day 0.
16051875|NCT02512497|Drug|Thymoglobulin|Participants receiving a graft from a matched unrelated donor receive rabbit Thymoglobulin; 0.5 mg/kg on Day -3, 1.5 mg/kg on Day -2 and 2.0 mg/kg on Day -1.
16051876|NCT02512484|Procedure|venepuncture, sputum collection, xray|venepuncture, sputum collection, xray
16051877|NCT02512471|Drug|Ropivacaine|brachial plexus block with ropivacaine 0.275%, MEV90 for USG-SCB (young group) brachial plexus block with ropivacaine 0.325%, MEV90 for USG-SCB (middle-aged group)
16051878|NCT02512458|Drug|Cabazitaxel|
16051879|NCT02512445|Behavioral|Trauma Informed Guilt Reduction Therapy|Trauma focused therapy
16051880|NCT02512445|Behavioral|Supportive Care Therapy|Supportive therapy
16051881|NCT02512432|Device|INTACS|asymmetrical corneal inserts to reduce, or eliminate myopia and astigmatism in patients with keratoconus to decrease dependence on contact lenses and spectacle correction, while potentially deferring need for corneal transplantation.
16051882|NCT02512419|Behavioral|Text-Enhanced Physical Activity Intervention Arm|Participants in the Text-Enhanced Physical Activity intervention arm of the study receive a Spanish language, motivationally-tailored, print-based + text-message physical activity intervention that specifically addresses the physical activity barriers and intervention needs/preferences of Mexican and Mexican American men.
16051883|NCT02512419|Behavioral|Health Education Control Arm|Participants will receive a Spanish language, print-based Wellness Contact control intervention addressing relevant health topics other than physical activity.
16051884|NCT02512419|Device|Actigraph GT3X|
16051885|NCT02512406|Other|The Sensory Profile|60 item questionnaire administered to participants age 6-10 with questions pertaining to sensory processing categories of Taste/Smell, Movement, Visual, Touch, Activity Level, and Auditory. Scores are tallied for each category. Results are plotted along an x and y-axis with one axis being perception or stimulus (low registration to sensory sensitivity) and the other being response to stimulus (sensation seeking to sensation avoiding). Each category is plotted along this axis and compared to normative data which is included in this tool.
16051886|NCT02512406|Other|The Adult/Adolescent Sensory Profile|60 item questionnaire administered to participants age 11 and older with questions pertaining to sensory processing categories of Taste/Smell, Movement, Visual, Touch, Activity Level, and Auditory. Scores are tallied for each category. Results are plotted along an x and y-axis with one axis being perception or stimulus (low registration to sensory sensitivity) and the other being response to stimulus (sensation seeking to sensation avoiding). Each category is plotted along this axis and compared to normative data which is included in this tool.
16051887|NCT02512406|Other|Children's Yale-Brown Obsessive Compulsive Scale|10-item symptom checklist questionnaire administered by a physician to participants aged 6-14. 1st part is a yes/no checklist of obsessions (1-42) and compulsions (43-67) experienced in the past or present. 2nd part is a scored severity scale with 10 questions in which they assign a 0-4 severity score which is summed for a total score.
16051888|NCT02512406|Other|Yale-Brown Obsessive Compulsive Scale|10-item symptom checklist questionnaire administered by a physician to participants aged 15 and older. 1st part is a yes/no checklist of obsessions (1-42) and compulsions (43-67) experienced in the past or present. 2nd part is a scored severity scale with 10 questions in which they assign a 0-4 severity score which is summed for a total score.
16051955|NCT02511873|Drug|Placebo|Placebo (looks like study drug but has no active ingredients) for 6 weeks with a dose range of 2mg to 8mg daily
16051889|NCT02512406|Other|Yale Global Tic Severity Scale|Clinician administered questionnaire given to all participants. Part 1 asks about 10 types of motor tics, 12 types of vocal tics (current, ever, age of onset, description). Part 2 is a severity rating that scores both motor and vocal tics on a 0-5 scale for each severity item: number of tics, intensity, frequency, complexity, interference, impairment. Totals are summed for all items.
16051890|NCT02512406|Other|Demographic Data|Data will be collected including: Age, duration of symptoms, presence or absence of autism spectrum disorder, presence or absence of OCD, presence or absence of ADHD.
16051891|NCT02512393|Device|Active tDCS|This group will receive tDCS with a constant current of 2 mA intensity will be applied for 20 minutes once a day for five consecutive days using a pair of thick (0.3 cm) rectangular surface sponge electrodes (5 cm x 7 cm) saturated with 10 mL of saline solution. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
16051892|NCT02512393|Device|Sham tDCS|This group will receive tDCS with a constant current of 2 mA intensity will be applied for 30 seconds once a day for five consecutive days using a pair of thick (0.3 cm) rectangular surface sponge electrodes (5 cm x 7 cm) saturated with 10 mL of saline solution. The anode electrode will be placed over M1 (C3 or C4 according to the 10-20 system for EEG electrode placement) of the hemisphere contralateral to the affected knee, and the cathode electrode will be placed over the supraorbital region (SO) ipsilateral to the affected knee (M1-SO montage).
16051893|NCT02512380|Drug|Docetaxel;oxaliplatin;s1|Docetaxel 60mg/m2 was administered on day 1 of every 14 days.oxaliplatin 85 mg/m2 was administered on day 2 every 14 days. 40-60 mg of oral S-1 according to body-surface area twice a day was given for 10 days every 14 days .
16051894|NCT02512380|Drug|oxaliplatin;s1|oxaliplatin 100 mg/m2 on day 1 every 21 days.40-60 mg of oral S-1 according to body-surface area twice a day was given for 2 weeks every 21 days .
16051895|NCT02512367|Other|Dental care education program|Dental care education program
16051896|NCT02512367|Other|Surveillance|Surveillance
16051897|NCT02512354|Other|Sample of a fragment of fetal tissue|
16051898|NCT02512354|Other|Parent's blood samples|
16051899|NCT02512341|Device|Computer Aided Auscultation (CAA)|
16051900|NCT02512328|Device|APP supported colonoscopy preparation|additional usage of an app for colonoscopy preparation
16051901|NCT02512315|Drug|Docetaxel (DOC)|Neoadjuvant chemotherapy (NACT) is administrated every 3 weeks with the regimen comprised of docetaxel plus cisplatin. A total of 4 cycles of NACT is applied. Docetaxel is given at a dose of 75mg/m2 on the first day of every cycle.
16051902|NCT02512315|Drug|Cisplatin (DDP)|Neoadjuvant chemotherapy (NACT) is administrated every 3 weeks with the regimen comprised of docetaxel plus cisplatin. A total of 4 cycles of NACT is applied. Cisplatin is given at a dose of 75mg/m2 on the first day of every cycle.
16051903|NCT02512315|Radiation|Concurrent chemoradiation (CCRT)|"The technology of radiotherapy is intensity-modulated radiation therapy (IMRT). A total dose of 66-72Gy is given to gross tumor of nasopharynx (GTVnx), 60-70Gy to positive neck lymph nodes (GTVnd), 60Gy to high-risk region (CTV1), and 50-54Gy to prophylactic irradiation region (CTV2).
~The regimen of concurrent chemotherapy is single-agent cisplatin 40mg/m2 weekly."
16051904|NCT02512302|Drug|SUN-101 via eFlow nebulizer|50 mcg glycopyrrolate via Electronic Nebulizer
16051905|NCT02512302|Drug|SUN-101 via eFlow nebulizer with activated charcoal|50 mcg glycopyrrolate via Electronic Nebulizer with activated charcoal
16051906|NCT02512302|Drug|Seebri® Breezhaler®|63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI
16051907|NCT02512302|Drug|Seebri® Breezhaler® with activated charcoal|63 mcg glycopyrronium bromide (50 mcg glycopyrronium) via DPI with activated charcoal
16051908|NCT02512302|Drug|Glycopyrrolate Injection|50 mcg glycopyrrolate via IV
16051909|NCT02512289|Device|tDCS (ELDITH) and RAT (REAplan)|Transcranial direct-current stimulation( ELDITH) and Robot-assisted therapy by using REAplan
16051910|NCT02512276|Behavioral|Telepharmacist intervention|The intervention consists of a brief telephonic consultation with a clinical pharmacist using behavioral interviewing techniques tailored to patient's level of health activation and progress reports of medication-taking and disease control. Based on the barriers identified during the initial telephone consultation, patients will be offered more intensive support including reminder and motivational text-messages, video visits and pillboxes.
16051911|NCT02512263|Procedure|Home-based training program|A home-based training program of 8 exercises to do 5 times a week during 9 weeks
16051912|NCT02512250|Other|Registry|
16051913|NCT02512237|Drug|ARX788|ARX788, an antibody drug conjugate
16051914|NCT02512224|Device|Parenteral nutrition|Participants are retrospectively selected with propensity score matching
16051915|NCT02512224|Device|Enteral nutrition|Participants are retrospectively selected with propensity score matching
16051916|NCT02512198|Behavioral|Prescription Data Feedback to GP Practices|GP practices will be randomly assigned to receive reports on one of the two topics. They will get these three times at six-monthly intervals. Within the feedback, alongside the patient-level analysis, there will be action-orientated messages to guide the GP practice.
16051917|NCT02512172|Drug|Oral CC - 486|
16051918|NCT02512172|Drug|Romidepsin|
16051919|NCT02512172|Drug|MK - 3475|
16051920|NCT02512159|Procedure|drenovac handcrafted|under local anesthesia, sepsis and antisepsis, place sterile field, prepared area go out all devitalized or necrotic tissue using liquid soap surgical and irrigation back saline 0.9%. We introduce a device to distribute the negative pressure or vacuum on ulcer; conducted margins make recommendations 5-12 mm over the edge of the wound, applying negative pressure or vacuum retracted sponges, likewise for the spare fewer gauze was placed Sterile adhesive film covering the defect to seal the system cover adequately the probe output nelaton not to submit drain the system. Connect the probe to the sterile nelaton this hose and a suction system with pressure gauge, pressure -80-125 mmHg. Change it every 72 hours.
16051956|NCT02511860|Dietary Supplement|Burdock|Subjects will consume burdock daily and will undergo laboratory tests to determine the effect of burdock, if any, on organ function.
16051957|NCT02511860|Dietary Supplement|Placebo|Methylcellulose (inert) tablet taken as placebo
16051994|NCT02511600|Other|Progel Sealant|After pleurectomy decortication, Progel® sealant added to the surface of the lung prior to closure of the chest.
16051921|NCT02512159|Procedure|Healing|"Were handled as follows:
~Under local anesthesia, prior asepsis and antisepsis of the skin ulcer with iodinepovidone sterile fields are placed, we proceeded to debridement of all necrotic tissue or devitalized then a cure with liquid soap surgery was performed and was irrigated with 1000 cc of solution physiological 0.9%, and finally the ulcer was covered with sterile gauze.
~healing of skin ulcers were performed every 24 hours.
~the evolution of skin ulcers was evaluated every 3 days, requesting a differential valuing of clinical and biochemical form the aforementioned variables."
16051922|NCT02512146|Procedure|colonoscopy|Patients will undergo colonoscopy and participants will get biopsies from the colon.
16051923|NCT02512133|Device|MIGS Hydrus Ivantis|implant of the micro stent in the nasal Schlemm's canal
16051924|NCT02512133|Procedure|360 degrees SLT|Laser Solutis SLT laser (Quantel Medical, Clermont-Ferrand, France): this frequency-doubled, Q-switched Nd:YAG laser emits light at a wavelength of 532 nm, with a pulse duration of 4 ns, a spot size of 400 µm and pulse energy ranging from 0.2 to 2 mJ
16051925|NCT02512120|Device|volume controlled ventilation|"After induction of anesthesia and intubation, patients will be applied VCV by Zeus®(Dräger, Germany).
~- Tidal volume : 8ml/kg(ieal body weight), inspiration:expiration ratio = 1:2, FiO2 = 0.5, fresh gas flow = 3L/min respiratory rate(RR) : 12/min. After position, RR can changed 2 times each per 5 minutes to maintain end tidal CO2 around 35. Positive end expiratory pressure will not used."
16051926|NCT02512120|Device|autoflow-volume controlled ventilation|"After induction of anesthesia and intubation, patients will be applied autoflow- VCV by Zeus®(Dräger, Germany).
~- Tidal volume : 8ml/kg(ideal body weight), inspiration:expiration ratio = 1:2, FiO2 = 0.5, fresh gas flow = 3L/min respiratory rate(RR) : 12/min. After position, RR can changed 2 times each per 5 minutes to maintain end tidal CO2 around 35. Positive end expiratory pressure will not used."
16051927|NCT02512107|Dietary Supplement|Juice Plus+|Dried fruit and vegetable juice capsule.
16051928|NCT02512107|Other|Placebo|Placebo capsule
16051929|NCT02512081|Other|No intervention applied|No intervention applied
16051930|NCT02512068|Drug|Trelagliptin 25 mg|Trelagliptin 25 mg Tablets
16051931|NCT02512068|Drug|Placebo|Placebo Tablets
16051932|NCT02512055|Drug|Ketamine|Repeated ketamine 2 mg/kg administration intravenously for sedation during each radiotherapy sessions
16051933|NCT02512042|Drug|Test-Brinzolamide 1% Ophthalmic suspension|
16051934|NCT02512042|Drug|Reference-Brinzolamide 1% Ophthalmic suspension|
16051935|NCT02512029|Drug|18F-AV-1451|
16051936|NCT02512016|Other|Study Procedures|"Pelvic Organ Prolapse Quantification exam (3rd tri, 8 wks and 1 yr postpartum)
~Intra-abdominal pressure measure. At 8 weeks: IAP during lifting 12.5 kg and abdominal muscle endurance testing. At 1 year: IAP during lifting 17.5 kg and abdominal muscle endurance testing.
~Accelerometry: Wrist accelerometer (objective quantification of physical activity) x 1 wk 2-3 and 5-6 wks and 6 mo postpartum.
~Measures of strength and body habitus:
~8 weeks and 1 year postpartum: Abdominal muscle endurance Abdominal adiposity Body mass index
~1 year postpartum: Pelvic floor muscle strength: tested using a Peritron manometer Body composition: using air displacement plethysmography using the BodPod
~Qualitative interviews: A smaller number of participants will be purposefully selected for the qualitative interviews in order to understand examples of the postpartum sensations and experiences of women with a wide variety of characteristics and from various social and cultural settings."
16051937|NCT02512003|Device|Fantom Scaffold|
16051938|NCT02511990|Biological|3 mg/kg, single dose IV administration of 10-1074|3 mg/kg, single dose IV administration of 10-1074
16051939|NCT02511990|Biological|10 mg/kg, single dose IV administration of 10-1074|10 mg/kg, single dose IV administration of 10-1074
16051940|NCT02511990|Biological|30 mg/kg, single dose IV administration of 10-1074|30 mg/kg, single dose IV administration of 10-1074
16051941|NCT02511977|Other|peri-implant examination|The prostheses were removed and all implants were evaluated: probing depth, plaque index and bleeding index.
16051942|NCT02511964|Behavioral|Interval Training at 1% Incline|Six Sessions of Running at 1% incline
16051943|NCT02511964|Behavioral|Interval Training at 10% Incline|Six Sessions of Running at 10% incline
16051944|NCT02511951|Procedure|pancreaticojejunostomy|"To create the posterior suturing layers, the needle is inserted from the posterior interior side of the pancreatic duct, passing through the dorsal region of the parenchyma of the pancreatic stump to the posterior surface of the pancreas approximately 0.5 cm distal to the cut edge. The other side of the needle starts from the inside of the jejunum lumen to the subserosa and then passes through the seromuscular layer to the posterior surface of the bowel.The anterior suturing layer is performed in the same manner.
~Two layer anatomosis with Duct-to-Mucosa pancreaticojejunostomy is performed by suturing the pancreatic parenchyma to the jejunal seromuscular layer and no stenting tube was used."
16051945|NCT02511938|Other|Menu Only|Restaurants will collaborate with project to develop and introduce new healthy kid's menu items. Project will provide recipes, preparation support, nutritional information, and printed menus to restaurants.
16051946|NCT02511938|Other|Menu Plus intervention|Restaurants will collaborate with project to develop and introduce new healthy kid's menu items. Project will provide recipes, preparation support, nutritional information, and printed menus to restaurants. In addition, project will provide promotional materials and brief restaurant staff trainings to promote the new menu.
16051947|NCT02511925|Other|Weekly poster of unit performance|Weekly feedback is provided to the ICU about current levels of hand hygiene compliance amongst doctors, nurses, and allied healthcare professionals
16051948|NCT02511925|Other|Daily email of personal feedback|Healthcare workers receive private and personal feedback via email regarding their individual performance benchmarked against the average performance for their professional grouping.
16051949|NCT02511925|Other|Active reminder from badge|The badge the healthcare worker is wearing vibrates if opportunities to perform hand hygiene are missed
16051950|NCT02511912|Procedure|V-Wave|The V-Wave shunt implantation procedure is a standard femoral venous access and inter-atrial septal puncture intervention. The shunt is placed through the Fossa Ovalis.
16051951|NCT02511899|Dietary Supplement|Mango fruit powder|Dietary supplement; Mango fruit powder
16051952|NCT02511886|Drug|Arbaclofen Placarbil|Arbaclofen Placarbil
16051953|NCT02511886|Drug|Placebo|Placebo matched tablets
16051954|NCT02511873|Drug|Fycompa|Subjects will take Fycompa for 6 weeks with a dose range of 2mg to 8mg daily
16052438|NCT02508246|Other|Pharmacological Study|Correlative studies
16051958|NCT02511847|Drug|Afatinib|"Afatinib 40 mg per day for 14 days, then evaluation, every subject will go into the following phase no matter whether she had response or not
~Afatinib 40 mg per day, day 1 to day 21, in combination with paclitaxel 80 mg/m² on days 1, 8, 15 in a 3-weekly course."
16051959|NCT02511834|Device|VEST External Support|
16051960|NCT02511834|Procedure|Coronary Artery Bypass Surgery|
16051961|NCT02511821|Other|Computer-Assisted Intervention|Complete online surveys
16051962|NCT02511821|Device|Vivofit watch|Wear Vivofit watch
16051963|NCT02511821|Other|Quality-of-Life Assessment|Ancillary studies
16051964|NCT02511821|Other|Questionnaire Administration|Ancillary studies
16051965|NCT02511808|Behavioral|Brief Advice|Brief Advice (BA) consists of a 20-minute session delivered by a study therapist, adhering to the NIAAA's Clinician Guide to Problem Drinkers. It includes personalized, normative feedback based on NIAAA drinking norms, goal selection, instructions on self-monitoring, discussion of drink reduction strategies, and distribution of the NIAAA bibliotherapy guide.
16051966|NCT02511808|Behavioral|Motivational Interviewing|Motivational Interviewing will consist of standard techniques, such as developing discrepancy, enhancing motivation, and developing a change plan, that have been adapted to treatment for problem drinkers.
16051967|NCT02511808|Behavioral|Behavioral Self-Control Training|Behavioral Self-Control Training will consist of Cognitive Behavioral Therapy adapted to problem drinkers, whose core components include a functional analysis, skills training, daily self-monitoring, homework, and graded exposures and mastery of high risk situations.
16051968|NCT02511795|Drug|AZD1775|"AZD1775 will be given twice daily (PO BID) over 3 days (6 doses) on Days 1-3 and 8-10 of each 21 day cycle combined with olaparib PO BID on Days 1-14 of each 21 day cycle.
~Olaparib will be given orally BID on Days 1-14."
16051969|NCT02511795|Drug|Olaparib|"AZD1775 will be given twice daily (PO BID) over 5 days (10 doses) on Days 1-5 and 8-12 of each 21 day cycle combined with olaparib PO BID on Days 1-14 of each 21 day cycle.
~Olaparib will be given orally BID on Days 1-14."
16051970|NCT02511782|Device|D-SQUAME Skin Sampling Discs|A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application.
16051971|NCT02511769|Behavioral|WEB-MAP Educational Control Group|OPEC (Online Patient Education Control) Group: The purpose of the patient education control group is to control for time, attention, and computer usage. This group will serve as an attention control condition. Children will continue with the standard medical care that has been prescribed for their pain problem. Children and parents will be provided with access to a revised version of the Web-MAP study website, which will have two functional components: 1) information from publicly available educational websites about pediatric chronic pain management, 2) diary and assessments. This version of the website differs from the one accessed by the treatment condition in that it does not provide access to behavioral and cognitive skills training via treatment modules for children and parents.
16051972|NCT02511769|Behavioral|WEB-MAP CBT|Web-MAP Group: Participants will have access to the full version of the web program. They will be asked to log in to the website using their own personal computer at home, work, school, or a public library. Participants in the Web-MAP group will have access to treatment modules and daily diaries on the web site. The online treatment will take between 8 and 9 weeks for participants to complete. Children and parents will be asked to log onto the web site, read through the treatment modules, and complete practice assignments to learn new skills (e.g., relaxation). Adolescents and parents will be asked to complete a total of 8 modules each.
16051973|NCT02511756|Device|Computed tomography X-ray system|Contrast-enhanced computed tomography of liver metastases
16051974|NCT02511743|Other|physicians|physicians taking care of patients with chronic Hepatitis B Virus infection, without intervention
16051975|NCT02511730|Device|FFDM Plus DBT|FujiFilm Aspire Cristalle System
16051976|NCT02511730|Device|FFDM|FujiFilm Aspire Cristalle System
16051977|NCT02511717|Other|Transcutaneous tibial nerve stimulation|Patch electrodes applied posterior to the medial malleolus, and 5-10 cm above the medial malleolus of the same leg, just behind the medial tibial edge. Bipolar stimulation setting will be used, with a frequency of 10 Hz, 200ms pulse, and the amplitude will be titrated up to patient's maximum nonpainful tolerance (between 0.5-10mA). This will be done by the patients at home 3x/week for 30 minutes, over 12 weeks.
16051978|NCT02511717|Other|Sham transcutaneous tibial nerve stimulation|Patch electrodes applied posterior to the lateral malleolus, and 5-10 cm above the lateral malleolus of the same leg. Bipolar stimulation setting will be used, with a frequency of 10 Hz, 200ms pulse, and the amplitude will be set a 1mA. This will be done by the patients at home 3x/week for 30 minutes, over 12 weeks.
16051979|NCT02511704|Drug|Nicotine|Multiple dose nicotine
16051980|NCT02511704|Drug|Nicotine|Multiple dose nicotine
16051981|NCT02511691|Drug|18F-PSS232|Diagnostic PET Tracer
16051982|NCT02511678|Device|Cryoablation|The application of repeated freeze and thaw cycles to the identified tissues.
16051983|NCT02511665|Drug|Metformin|Given metformin
16051984|NCT02511665|Radiation|PET-MRI Scan|Patients will under go 2 PET-MRI scans in the PET-MRI substudy arm one before treatment with metformin and one after
16051985|NCT02511665|Drug|Placebo|Given placebo
16051986|NCT02511652|Device|Ambu AuraGain evaluation|Evaluation of clinical performance in terms of Insertion, ventilation, position and complications
16051987|NCT02511652|Device|LMA Supreme evaluation|Evaluation of clinical performance in terms of Insertion, ventilation, position and complications
16051988|NCT02511652|Procedure|Laparoscopic surgery|Gynecologic laparoscopic surgery in the trendelemburg position
16051989|NCT02511639|Drug|Everolimus|Everolimus is formulated as tablets of 10 mg strength for oral administration.
16051990|NCT02511639|Drug|Aromatase Inhibitors|Anastrozole is formulated as tablets of 1 mg strength for oral administration. Letrozole is formulated as tablets of 2.5 mg strength for oral administration. Exemestane is formulated as tablets of 25 mg strength for oral administration.
16051991|NCT02511613|Drug|Squalamine Lactate Ophthalmic Solution, 0.2%|Squalamine Lactate Ophthalmic Solution, 0.2% administered BID
16051992|NCT02511613|Drug|Placebo Ophthalmic Solution|Placebo Ophthalmic Solution, administered BID
16051993|NCT02511613|Drug|ranibizumab|ranibizumab intravitreal injection
16052857|NCT02505035|Behavioral|Default ordering of palliative consult|
16051995|NCT02511600|Other|Talcum Powder|After pleurectomy decortication, talcum powder added to the surface of the lung prior to closure of the chest.
16051996|NCT02511600|Behavioral|Pain Questionnaire|Participants complete pain scale 3 times each day while in the hospital. Pain is rated on a pain scale of 0 - 10.
16051997|NCT02511587|Biological|FSME-Immune vaccination|booster vaccination with FSME-Immune
16051998|NCT02511574|Drug|natural progesterone|
16051999|NCT02511574|Device|cervical pessary|
16052000|NCT02511561|Drug|OTO-201 (ciprofloxacin)|
16052001|NCT02511548|Other|Financial incentive|Financial incentive will be proposed to participant of the intervention arm
16052002|NCT02511535|Biological|TBE booster vaccination|
16052003|NCT02511522|Other|Best Supportive Care|Including analgesics, palliative care and/or pain specialist assessment as needed
16052004|NCT02511522|Radiation|Palliative Radiation Therapy|8 Gy in 1 fraction in whole liver or near whole liver. Including anti-emetic pre-medications
16052005|NCT02511509|Device|Bifrontal electroconvulsive therapy|The centre of each electrode will be placed 4-5 cm above the outer canthus of the eye along a vertical line perpendicular to a line connecting the pupils.
16052006|NCT02511509|Device|Bitemporal electroconvulsive therapy|The centre of the stimulus electrodes will be applied 2-3 cm above the midpoint of the line connecting the outer canthus of the eye and the external auditory meatus on each side of the individual's head.
16052007|NCT02511483|Drug|Propranolol PO|20 mg PO BID Day of Surgery, 30 mg PO BID Day I and Day II post-op.
16052008|NCT02511483|Drug|IV-PCA morphine|Morphine delivered via IV-PCA pump for 48 hours after surgery with standard program: bolus 1 mg, lock out 7 minutes, no background infusion.
16052009|NCT02511483|Drug|Placebo PO|Placebo tablets administered with the same schedule of Propranolol tablets
16052010|NCT02511483|Procedure|Quantitative Sensory Testing (QST)|Assessment of PPT (Pressure Pain Threshold) by pressure algometer and assessment of the post-op area of hyperalgesia by von Frey hair no. 16.
16052011|NCT02511483|Other|Psychometric assessment|Questionnaires assessing for sleep quality (PSQI: Pittsburgh Sleep Quality Index), pain quality (sfMGPQ-Short Form-McGill Pain Questionnaire), somatization-depression-anxiety (SCL-90-R: Symptom Checklist 90 Revised), evolution of post-operative chronic pain (PQRS: Post-operative Quality of Recovery Scale)
16052012|NCT02511483|Genetic|COMT-haplotypes|Assessing of High Pain Sensitivity (HPS), Average Pain Sensitivity (APS) and Low Pain Sensitivity (LPS) haplotypes for COMT by genotyping peripheral blood samples.
16052013|NCT02511470|Other|Metronome on|Metronome on during participants performance of CPR on a pediatric manikin
16052014|NCT02511470|Other|Metronome off|Metronome off during participants performance of CPR on a pediatric manikin
16052015|NCT02511444|Other|GBS culture and real time PCR|patients with signs and symptoms of threatened preterm labor, or indications for preterm delivery will have GBS colonization screened by culture and real time PCR.
16052016|NCT02511431|Drug|Lonafarnib|prenylation inhibitor to be administered daily at doses of 50 mg, 75 mg or 100 mg.
16052017|NCT02511431|Drug|Ritonavir|FDA approved drug for use of boosting other drugs. Will be used to boost Lonafarnib as they both use the same cytochrome P450 system. Will be administered at 100 mg daily.
16052018|NCT02511431|Other|Placebo|Placebo
16052019|NCT02511418|Drug|Simvastatin|
16052020|NCT02511405|Drug|VB-111 + bevacizumab|"VB-111 will be administered intravenously at a dose of 1x10e13 VPs every 2 months
~Bevacizumab will be administered intravenously at a dose of 10mg/kg every 2 weeks"
16052021|NCT02511405|Drug|Bevacizumab|Bevacizumab will be administered intravenously at a dose of 10mg/kg every 2 weeks
16052022|NCT02511392|Procedure|rTMS-1Hz|
16052023|NCT02511392|Procedure|rTMS-10 Hz|
16052024|NCT02511392|Procedure|Sham rTMS|
16052025|NCT02511379|Other|Propylene Glycol 0.6% eye drops|
16052026|NCT02511366|Other|Ileal infusion of casein|Intraileal infusion of casein
16052027|NCT02511366|Other|Ileal infusion of tap water|Intraileal infusion of tap water
16052028|NCT02511353|Drug|ivermectin|
16052029|NCT02511353|Drug|placebo|Placebo for ivermectin.
16052030|NCT02511353|Drug|dihydroartemisinin-piperaquine|
16052031|NCT02511340|Drug|Flumatinib mesylate tablet 600 mg qd|Flumatinib mesylate tablet 600 mg qd in CML-AP or CML-BP patients
16052032|NCT02511327|Drug|Infant pertussis vaccination|Infants receive pertussis vaccines according to the national recommended schedule
16052033|NCT02511314|Device|TENA Identifi|TENA Identifi
16052034|NCT02511301|Device|Cyrcadia CBR™ device placement for abnormality screening|Cyrcadia CBR™ device, including adhesive patches on both breasts connected to a small recorder, is placed on the study subject for 2 to 24 hours. After the test period, the CBR™ will be removed and the data will be downloaded to a central site for analysis. There are no interventions after the CBR™ is removed from the Study Subject.
16052035|NCT02511275|Procedure|Renal microdialysis|Renal microdialysis is an innovative and promising technique in the monitoring of renal ischemia. Its sterile nature enables intraoperative use to give us real-time reflection of the in situ metabolism. In Patients who participated in clinical research with this microinvasive technique, no complications including bleeding has been reported.
16052036|NCT02511262|Device|illumigene® Mycoplasma Direct, illumipro-10|DNA amplification assay
16052037|NCT02511236|Behavioral|Group Cognitive Behavioral Therapy|The four-week CBT protocol includes 4 sessions during week 1, 2 sessions during week 2, 1 session during week 3, and 1 session during week 4. Sessions may include a functional analysis of smoking patterns, environmental cues, and motivation for change, and cover nicotine addiction and withdrawal, health consequences, benefits of cessation, stress management, negative affect, alcohol use, triggers, coping responses, cognitive restructuring, social support, decision making, weight control, and physical activity.
16052079|NCT02510911|Drug|Caffeine (100 mg)|"Patients after laparoscopic colectomy will receive 3 times daily capsules with 100 mg caffeine together with the meals.
~First capsule will be taken on the evening of surgery if surgery was completed before 1 pm, otherwise the first capsule will be taken on the morning of the next day.
~Treatment consists of 10 capsules and will be stopped after the first solid bowel movement."
16052190|NCT02510079|Biological|Autologous human Schwann cells|Schwann cells harvested from the sural nerve will be autologously transplanted along sural nerve autografts wrapped in a collagen matrix (Duragen).
16052038|NCT02511236|Behavioral|General Health Education|The four-week CBT protocol includes 4 sessions during week 1, 2 sessions during week 2, 1 session during week 3, and 1 session during week 4. Sessions may include didactic information on tobacco-associated morbidities, such as heart disease, diabetes, and hypertension. Content may include Power Point-delivered lectures on the prevalence, etiology, basic pathology, symptom patterns, and treatment of the conditions, and discussion questions designed to facilitate learning and interest. Smoking cessation specific topics will not be addressed, and coping skills will not be provided. Participants will be allowed to share feelings regarding smoking (if they mention them) and general questions will be answered, although no specific behavioral quitting advice will be provided (i.e., they will be encouraged to adhere to the TNP protocol).
16052039|NCT02511236|Drug|Transdermal Nicotine Patch|Participants will be prescribed up to 8 weeks of transdermal nicotine patch therapy, including 21 mg for 4 weeks, 14 mg for 2 weeks, and 7 mg for 2 weeks. Dosages will be adjusted per manufacturer recommendations.
16052040|NCT02511223|Drug|OLAPARIB|Olaparib 300 MG twice a day per os given every day until disease progression or toxicity
16052041|NCT02511210|Behavioral|regional anesthesia|preoperative anxiety
16052042|NCT02511210|Behavioral|general anesthesia|preoperative anxiety
16052043|NCT02511197|Drug|68Ga-NOTA-PRGD2|68Ga-NOTA-PRGD2 were injected into the patients before the PET/CT scans
16052044|NCT02511197|Device|PET/CT|
16052045|NCT02511184|Drug|Crizotinib|To test 3 dose levels of crizotinib in combination with pembrolizumab 200 mg iv infusion every 3 weeks
16052046|NCT02511184|Drug|Pembrolizumab|To test pembrolizumab at 200 mg every 3 weeks in combination with crizotinib at 3 dose levels.
16052047|NCT02511171|Other|Cranial osteopathic manipulative therapy|
16052048|NCT02511158|Procedure|Ligament of the knee reconstruction|Reconstruction of ligaments of the knee by autografts
16052049|NCT02511145|Other|occlusive bandage|
16052050|NCT02511145|Device|ablative fractional CO2 laser pretreatment|
16052051|NCT02511145|Device|Microneedles pretreatment|
16052052|NCT02511145|Drug|METVIXIA Cream|
16052053|NCT02511132|Biological|Vigil|Vigil 1.0 x 10e7 cells/injection, intradermally on Day 15 and every 43 weeks thereafter.
16052054|NCT02511132|Drug|Temozolomide|oral temozolimidetemozolomide 100 mg/m2 daily (Days 1 - 5, total dose 500 mg/m2/cycle)
16052055|NCT02511132|Drug|Irinotecan|irinotecan 50 mg/m2 daily (Days 1 - 5, total dose 250mg/m2/cycle), orally or irinotecan 20mg/m2 daily (Days 1 - 5, total dose 100mg/m2/cycle ), intravenously
16052059|NCT02511093|Behavioral|TBC intervention|"A structured collaborative intervention delivered by trained nurses of ambulatory clinics and by community pharmacists working in collaboration with physicians during 6-month of follow-up includes:
~BP measurements;
~an educational and counselling intervention on patient adherence;
~an educational and counselling intervention on lifestyle (physical activity and diet) Physicians adjust antihypertensive medications based on nurse and pharmacist feedback."
16052060|NCT02511080|Device|Spot-On|use of active hot measures
16052061|NCT02511067|Drug|Tocilizumab|Intravenous Infusion of Tocilizumab ( 8.0 mg/kg)
16052062|NCT02511067|Drug|Ranibizumab|Intravitreal injection of Ranibizumab (0.3mg)
16052063|NCT02511054|Drug|Chloroquine (CQ)|Chloroquine Phosphate is a 4-aminoquinoline compound that is commercially available for oral administration. It is a white, odorless, bitter tasting, crystalline substance freely soluble in water; and widely used for the treatment andprophylaxis of malaria. It is supplied and manufactured in tablets of 500 mg (equivalent to 300 mg chloroquine phosphaste base)
16052064|NCT02511054|Drug|Pyrimethamine (PYR)|PYR is a folic acid antagonist that is commercially available; and has been commonly used as antimalarial drug for both treatment and prevention of malaria, usually in combination with sulfadoxine in adults, pregnant women, and children worldwide. It is manufactured in tablets of 25 mg.
16052065|NCT02511054|Biological|Sanaria PfSPZ Challenge (NF54)|Sanaria PfSPZ Challenge are aseptic, cryopreserved P.falciparum sporozoites used for CHMI trials, produced by the biotechnology company; Sanaria Inc. In brief, manufacture includes the production, under traditional environmental conditions, of eggs from a colony of A. stephensi mosquitoes housed in a controlled environmental chamber. The sporozoites are purified, counted, and, at a specified concentration, cryopreserved. Cryopreservation commences with the addition of cryoprotective additives to the purified sporozoites to produce the Sanaria PfSPZ Challenge product. Sanaria PfSPZ Challenge is dispensed into screw-cap vials containing 15,000, 50,000, or 100,000 PfSPZ in a 20 L aliquot. Sanaria PfSPZ Challenge is stored in liquid nitrogen vapour phase at 140 (Infinite)C to -196 (Infinite)C.
16052066|NCT02511041|Drug|N-Acetylglucosamine (GlcNAc)|N-acetylglucosamine (GlcNAc), 2-acetamino-2-deoxy- <=-Dglucose, or 2- acetylamino)-2- deoxy-D-glucose, is a monosaccharide derivative of glucose. It is classified as dietary supplement in the United States. In general, it is a white and slightly sweet powder that melts at 221 degrees C. The solubility of GlcNAc is 25% in water, and 1% aqueous solutions are colorless and clear. GlcNAc is contraindicated for patients receiving warfarin, chemotherapy or diabetes drugs. As GlcNAc may interfere with blood sugar control during and after surgery, it is contraindicated during the two weeks prior to major surgery.
16052067|NCT02511041|Drug|Uridine|Uridine 5 -monophosphate (UMP) disodium salt is a water soluble colorless crystalline powder which melts at 202oC.
16052069|NCT02510976|Drug|prucalopride|
16052070|NCT02510976|Drug|placebo|
16052071|NCT02510963|Drug|Tenofovir Disoproxil Fumarate|Use Tenofovir at 24week of gestation
16052072|NCT02510963|Drug|Tenofovir Disoproxil Fumarate|Use Tenofovir at 28week of gestation
16052073|NCT02510963|Drug|Tenofovir Disoproxil Fumarate|Use Tenofovir at 32week of gestation
16052074|NCT02510950|Biological|Personalized peptide vaccine|
16052075|NCT02510950|Drug|Poly-ICLC|
16052076|NCT02510950|Drug|Temozolomide|
16052077|NCT02510937|Drug|CC-90001|
16052078|NCT02510924|Device|Tracheal intubation|tracheal intubation with Airtraq sp vs Airtraq mobile
16052080|NCT02510911|Drug|Caffeine (200 mg)|"Patients after laparoscopic colectomy will receive 3 times daily capsules with 200 mg caffeine together with the meals.
~First capsule will be taken on the evening of surgery if surgery was completed before 1 pm, otherwise the first capsule will be taken on the morning of the next day.
~Treatment consists of 10 capsules and will be stopped after the first solid bowel movement."
16052081|NCT02510911|Drug|corn starch (250 mg approx.)|"Patients after laparoscopic colectomy will receive 3 times daily capsules with 250 mg corn starch together with the meals.
~First capsule will be taken on the evening of surgery if surgery was completed before 1 pm, otherwise the first capsule will be taken on the morning of the next day.
~Treatment consists of 10 capsules and will be stopped after the first solid bowel movement."
16052082|NCT02510911|Other|Radiopaque marker|"On the morning of the first, second and third day after surgery patients will take 1 capsule each day with radiopaque markers .
~On day 4 after surgery an abdominal X-ray will be performed to localize the markers.
~Each gelatin capsule contains 10 markers consisting of polyurethane encapsulated barium sulfate (40%)."
16052083|NCT02510898|Behavioral|6-week Writing to Heal course|"During this 6-week class, a writing-to-heal instructor will coach participants through a simple progression of writing exercises. Participation requires neither any prior writing experience nor any aspiration to become a writer. In fact, the practices cultivate participants' natural abilities to express the ideas that define who they are and how they experience their lives.
~Weekly sessions build on previous sessions to provide a progression of experiences for participants to develop their natural styles of writing-to-heal. The instructor will guide participants through a variety of modes of writing that enhance health in different ways."
16052084|NCT02510885|Device|AngioVue SD-OCT|OCT-A allows noninvasive, high-resolution imaging of the microvasculature of the retina and choroid, without intravenous dye administration. SD-OCT units use the light source used in commercially available and FDA-cleared OCT units on a modified platform. Optovue, Inc. has developed a customized SD-OCT system that implements a novel algorithm, the amplitude-based method of split-spectrum amplitude-decorrelation angiography (SSADA) for OCT-A. This detects motion in the blood vessel lumen by measuring the variation in reflected OCT signal amplitude between consecutive cross-sectional scans. Optovue has integrated the novel SSADA algorithm into their commercially approved RTVue SD-OCT unit for their OCT-A unit, the AngioVue. This unit is being conducted under an abbreviated IDE.
16052085|NCT02510872|Other|18F-FDG PET combined with CT with iodinated contrast injection|
16052086|NCT02510872|Other|18F-FDG PET combined with CT without injection|
16052087|NCT02510859|Other|Systematic nutritional consultation at home|"Patients will be followed by a dietician at the patient's home at weeks 2 (S2) and 4 (S4) of radiotherapy, then at the end of radiotherapy at T0. Monitoring will be continued 15 days after the end of irradiation and then one month (T1 and 2 months (T2). A personalized follow will be performed and a document entitled Dietary own program will be given to the patient."
16052088|NCT02510846|Behavioral|Intensive educative management|5 hours a week
16052089|NCT02510833|Behavioral|Exercises oriented, manual and monitoring by phone|Individual meeting to guide therapeutic exercises (stretching, mobility, balance and strength), manual with these exercises for support in practice at home and weekly monitoring by phone. Patients will be oriented to do exercises three times per week for twelve weeks.
16052090|NCT02510833|Behavioral|Exercises oriented, manual and without monitoring by phone|Lectures (optatives) about therapeutic exercises (stretching, mobility, balance and strength) in days of medical consultation, manual with these exercises for support in practice at home, without weekly monitoring by phone. Patients will be oriented to do exercises three times per week for twelve weeks.
16052091|NCT02510820|Device|comfilcon A|soft contact lens
16052092|NCT02510820|Device|Synergi|Multipurpose solution
16052093|NCT02510820|Device|Biotrue|Multipurpose solution
16052094|NCT02510820|Other|stenfilcon A|daily disposable contact lenses for washout period
16052095|NCT02510807|Other|Pedometer|The use of a pedometer will demonstrate improvement in the following health outcomes in patients with PAD by acting as a method of surveillance to improve compliance with a walking regimen
16052096|NCT02510794|Drug|Ranibizumab|Ranibizumab will be administered at dose of 0.5 mg monthly ITV injections of 10-mg/mL formulation or delivered through the implant with three different formulations.
16052097|NCT02510781|Drug|Epirubicin|75mg/m2 d1 evry 21days
16052098|NCT02510781|Drug|Docetaxel|75mg/m2 d1 evry 21days
16052099|NCT02510781|Drug|Trastuzumab|6mg/kg(loading dosage is 8mg/kg)
16052100|NCT02510781|Drug|Carboplatin|Area Under Curve(AUC)=6 d1 evry 21days
16052101|NCT02510768|Device|ELAPR002f|Intradermal implant
16052102|NCT02510768|Device|ELAPR002g|Intradermal implant
16052103|NCT02510768|Device|Saline|Intradermal implant
16052104|NCT02510755|Other|MRI|
16052105|NCT02510742|Device|Neurostimulation|Neurostimulation of sphenopalatine ganglion (SPG) of 20 Hz
16052106|NCT02510742|Device|Sham stimulation|Sham stimulation of sphenopalatine ganglion (SPG) with amplitude=0
16052107|NCT02510729|Device|Neurostimulation|
16052108|NCT02510729|Device|Sham stimulation|
16052109|NCT02510716|Behavioral|SGR|
16052110|NCT02510716|Behavioral|Support message only|
16052111|NCT02510703|Other|Coronary endothelial function measurements by quantitative method (TEP at 15O-H2O)|
16052112|NCT02510677|Other|myocardial perfusion scintigraphy|
16052113|NCT02510664|Behavioral|Diabetes Strengths Study|"The intervention consists of: (A) assessing youth and family diabetes strengths and adherence prior to each visit, and (B) training diabetes care providers to tailor their clinical encounters around reinforcing each patient and family's unique diabetes strengths profile generated from the strengths and adherence assessments."
16052114|NCT02510651|Procedure|Melanocyte-keratinocyte suspension|Treatment of non-segmental vitiligo by CO2 laser followed by melanocyte-keratinocyte suspension.
16052115|NCT02510625|Procedure|Anatomic Glenoid Reconstruction|Distal tibia bone graft
16052116|NCT02510625|Procedure|Arthroscopic bankart Repair|Arthroscopic bankart Repair
16052117|NCT02510612|Drug|Dexmedetomidine|During anesthesia induction, all patients will be given propofol,fentanyl,vecuronium bromide.But before induction start in Dexmedetomidine(D) group, patient will be given dexmedetomidine 1μg/Kg for 10 minutes In anesthesia maintenance, D group will be given dexmedetomidine 0.4μg/Kg.h until 40 minutes before the end of surgery
16053051|NCT02503722|Drug|Osimertinib|Given PO
16052118|NCT02510612|Drug|placebo|During anesthesia induction, all patients will be given propofol,fentanyl,vecuronium bromide.But before induction start in Placebo(P) group, patient will be given placebo for 10 minutes In anesthesia maintenance, D group will be given placebo until 40 minutes before the end of surgery
16052119|NCT02510599|Drug|solithromycin|
16052120|NCT02510586|Drug|Sevoflurane|administer 1.0 MAC (1.7~2.0 vol%) of sevoflurane for 30 minutes after vascular anastomosis completed
16052121|NCT02510560|Drug|NTRA-2112|
16052122|NCT02510560|Drug|Placebo|
16052123|NCT02510547|Procedure|CrossBoss Catheter|Upfront use of the CrossBoss catheter for CTO lesion crossing
16052124|NCT02510547|Procedure|Antegrade Wire Escalation Strategy|Upfront guidewire escalation strategy for CTO lesion crossing
16052125|NCT02510534|Drug|Menopur 150 international units|Menopur 150 international units given x 1 dose
16052126|NCT02510534|Drug|Endometrin 100 mg|Endometrin 100mg twice daily x 14 days
16052127|NCT02510521|Device|acute muscle exercise by NMES|
16052128|NCT02510521|Device|daily workout sequence with NMES in one week|
16052129|NCT02510521|Other|rest situation|
16052130|NCT02510508|Behavioral|Group CRAFT|CSOs will receive seven weekly 90 min sessions of CRAFT + Self-Directed CRAFT Delivery
16052131|NCT02510508|Behavioral|Self-Directed CRAFT Delivery|CRAFT self-help book (Self Directed CRAFT Delivery)
16052132|NCT02510508|Other|Non-intervention|Non-intervention
16052133|NCT02510495|Procedure|"30 group"|A small sphincterotomy (EST) was performed prior to the EPBD, the length of a small sphincterotomy was considered as no larger than the range which from the orifice to the top one-third of the papilla. a CRE balloon (diameter 8, 9, 10, 11, 12, 13.5, 15; Boston Scientific) was chosen according to the diameter of bile duct. It was placed across the papilla orifice and then gradually filled with diluted contrast in 15 seconds. When the waist disappeared, the balloon was inflated till 30 seconds prior deflated. The stones were then retrieved by a basket or retrieval balloon. Mechanical lithotripsy was used if necessary.
16052134|NCT02510495|Procedure|"60 group"|A small sphincterotomy (EST) was performed prior to the EPBD, the length of a small sphincterotomy was considered as no larger than the range which from the orifice to the top one-third of the papilla. a CRE balloon (diameter 8, 9, 10, 11, 12, 13.5, 15; Boston Scientific) was chosen according to the diameter of bile duct. It was placed across the papilla orifice and then gradually filled with diluted contrast in 15 seconds. When the waist disappeared, the balloon was inflated till 60 seconds prior deflated. The stones were then retrieved by a basket or retrieval balloon. Mechanical lithotripsy was used if necessary.
16052135|NCT02510495|Procedure|"180 group"|A small sphincterotomy (EST) was performed prior to the EPBD, the length of a small sphincterotomy was considered as no larger than the range which from the orifice to the top one-third of the papilla. a CRE balloon (diameter 8, 9, 10, 11, 12, 13.5, 15; Boston Scientific) was chosen according to the diameter of bile duct. It was placed across the papilla orifice and then gradually filled with diluted contrast in 15 seconds. When the waist disappeared, the balloon was inflated till 180 seconds prior deflated. The stones were then retrieved by a basket or retrieval balloon. Mechanical lithotripsy was used if necessary.
16052136|NCT02510495|Procedure|"300 group"|A small sphincterotomy (EST) was performed prior to the EPBD, the length of a small sphincterotomy was considered as no larger than the range which from the orifice to the top one-third of the papilla. a CRE balloon (diameter 8, 9, 10, 11, 12, 13.5, 15; Boston Scientific) was chosen according to the diameter of bile duct. It was placed across the papilla orifice and then gradually filled with diluted contrast in 15 seconds. When the waist disappeared, the balloon was inflated till 300 seconds prior deflated. The stones were then retrieved by a basket or retrieval balloon. Mechanical lithotripsy was used if necessary.
16052137|NCT02510482|Other|No intervention|
16052138|NCT02510469|Drug|Apatinib|Apatinib Mesylate Tablets 500 mg qd p.o.
16052139|NCT02510456|Device|Diffuse Optical Spectroscopy Imaging (DOSI) - Neoadjuvant Chemo (NAC) Cohort|Subjects will have up to 9 DOSI scans at 6 different time points during the course of their neoadjuvant chemotherapy. The time course of chemotherapy may vary between 3-9 months depending on the type chemotherapy subjects receive. Depending on chemotherapy schedule, subjects may or may not be asked to participate in all the 6 measurement time points. The number of DOSI scans each subject requires will be decided during consent. Each DOSI scan will take about 30-60 minutes, although scans at infusion time point will take longer in total due to repeated or continuous measurements.
16052140|NCT02510456|Device|Diffuse Optical Spectroscopy Imaging (DOSI) - Non-NAC Cohort|Subjects will have 1 DOSI scan at baseline. The DOSI scan will take about 30-60 minutes.
16052141|NCT02510443|Device|ESS305 (Essure, BAY1454032)|Bilateral insert placement
16052142|NCT02510430|Behavioral|Re-Patterning Sitting Time Group|This is a behavioral intervention to help women interrupt long bouts of sitting time by incorporating standing breaks into their lifestyle.
16052143|NCT02510430|Behavioral|Reducing Sitting Time Group|This is a behavioral intervention to help women reduce their overall accumulated sitting time by 2 hours per day.
16052144|NCT02510430|Behavioral|Usual Care|This intervention consists solely of follow-up contact to control for attention effects and reduce attrition.
16052145|NCT02510417|Biological|VSTs|most closely HLA-matched multivirus-specific T cell lines obtained from a bank of allogeneic virus-specific T cell lines (VSTs) have antiviral activity against three viruses: EBV, CMV and adenovirus
16052146|NCT02510404|Biological|mCTLs|The investigators have elected to limit this phase I study to PIDD patients with active viral infections unable to be controlled with standard pharmacotherapy, who are therefore likely to benefit from mCTLs treatment. This trial will be performed as dose-escalation study. Patients will be evaluated for matched lines from a bank of third-party mCTLs, derived from CMV seropositive donors. These lines will have been used clinically in prior clinical trials, with safety demonstrated in the post-HSCT setting.
16052147|NCT02510391|Behavioral|PIPA|Parent-training Intervention for Preschoolers with Anxiety (PIPA) is a behaviorally based modular treatment program for emotional and behavioral problems in young children. 12 sixty minute sessions will be delivered weekly. This intervention employs a modular format following a treatment algorithm in which therapy modules are selected by the therapist and supervisor on a session-by-session basis to address the most pressing clinical needs. Minimum session requirements for parent training/education and fear hierarchy/exposure are set to insure adequate dose of core exposure and response prevention for anxiety across cases.
16052189|NCT02510092|Device|Percutaneous coronary intervention with new generation fully resorbable scaffold|
16052148|NCT02510378|Radiation|Short course radiotherapy|"Patients with rectal cancer and resectable liver metastases receive 25 Gy in 5 fractions of 5 Gy over 5 days to the pelvis and XELOX consolidating chemotherapy (with or without target therapy) al least 4 cycles after 2 weeks.
~After evaluation, patients with resectable rectal cancer and liver metastasis will undergo surgery. Those patients with unresectable lesions will receive chemotherapy."
16052149|NCT02510365|Biological|Functional collagen scaffold|Patients will receive functional neural regeneration collagen scaffold and patients will undergo a comprehensive rehabilitation and psychological measures after surgery.
16052150|NCT02510339|Other|Observation|Administration of two questionnairs during post operative visits.
16052151|NCT02510313|Other|Sugira Muryango|"Strong Families, Thriving Children Sugira Muryango is a home-visiting intervention that empowers low-income families enrolled in Rwanda's social protection system to support early childhood development and healthy family functioning."
16052156|NCT02510287|Drug|Bupivacaine and Fentanyl Initial Dose|10 ml of 0.1% bupivacaine (2 ml of 0.5% bupivacaine and 50 mcg / ml fentanyl in 7 ml of normal saline solution)
16052157|NCT02510287|Drug|Bupivacaine and Fentanyl: Continuous Epidural Infusion|0.1% bupivacaine and fentanyl 2 mcg / ml (8-12 ml / hour)
16052158|NCT02510287|Drug|Bupivacaine and Fentanyl: Programmed Intermittent Epidural Bolus|A 0.1% bupivacaine and fentanyl 2 mcg / ml (8-12ml) bolus will be administered each hour at a rate of 500ml/hour
16052159|NCT02510287|Drug|Rescue Bolus|Upon patient request, rescue bolus of 8-10 ml of 0.1% bupivacaine will be administered.
16052160|NCT02510287|Drug|Lidocaine|If needed, during the second phase (9-10 centimeters of cervical dilation) a 2% lidocaine without epinephrine (8-10 cc) bolus will be administered.
16052161|NCT02510274|Drug|ASP3325|oral
16052163|NCT02510248|Drug|AL-704|JNJ-54257099 (also known as ALS-022704 or AL-704) is a hepatitis C virus (HCV) nonstructural (NS)5B inhibitor, belonging to the nucleoside / nucleotide inhibitor class, and is being developed as an orally administered anti-HCV therapeutic.
16052164|NCT02510248|Drug|Placebo|Placebo to match AL-704
16052165|NCT02510235|Device|Lubricin|Lubricin 150 µg/ml eye drops
16052166|NCT02510235|Device|Sodium Hyaluronate|Sodium hyaluronate 0.13% eye drops
16052167|NCT02510222|Dietary Supplement|Oral magnesium sulfate|Magnesium sulfate 4% concentration in a dose of 65 mg/day for infants and children aged 1-3 years , 110 mg/day for those 3-8 years and 350 mg/day for those above 9 years .Each 1 ml of the magnesium sulfate used contains 0.325 mEq (milliequivalent) of elemental magnesium which equals to 4 mg elemental magnesium .
16052168|NCT02510222|Other|Placebo|
16052169|NCT02510209|Behavioral|Teen Outreach Program|TOP® is a youth development and service learning program for youth ages 12 to 17 designed to reduce teenage pregnancy and increase school success by helping youth develop a positive self-image, life management skills, and realistic goals. The TOP® program model consists of three components implemented in school, after school, or in community settings over nine consecutive months: (1) weekly curriculum sessions, (2) community service learning (CSL), and (3) positive adult guidance and support. The TOP® Changing Scenes® curriculum is separated into four age- and stage-appropriate levels, which range from Level 1, typically for youth ages 12 or 13, to Level 4, typically for youth age 17.
16052170|NCT02510196|Behavioral|reminder|
16052171|NCT02510183|Device|Acupressure Wrist Band|Acupressure wrist band is a knitted elasticated wrist band, which operates by applying pressure on the P6 acupressure point on each wrist by means of a plastic stud.
16052172|NCT02510183|Device|Placebo Acupressure Wrist Band|Placebo Acupressure Wrist Band is a knitted elasticated wrist band without a plastic stud.
16052173|NCT02510170|Other|no intervention|
16052174|NCT02510157|Drug|Dexamethasone|active comparator
16052175|NCT02510157|Drug|Normal Saline|placebo controlled intervention
16052176|NCT02510157|Drug|sugammadex|sugammadex is administered in both groups to reverse deep neuromuscular blockade at the end of surgery
16052177|NCT02510144|Drug|Skin Prep Chlorhexidine|3 day preoperative skin prep prior to surgery
16052178|NCT02510144|Drug|Skin Prep Benzoyl Peroxide|3 day preoperative skin prep prior to surgery
16052179|NCT02510131|Behavioral|Exercises|To compare Hyacinth exercise with Kegel's exercise in improving urinary incontinence
16052180|NCT02510118|Drug|mFOLFOX6|mFOLFOX6 regimen is a combination therapy of oxaliplatin (85 mg/m^2) administered as a 2-hour infusion on Day 1; leucovorin (400 mg/m^2) administered as a 2-hour infusion on Day 1; followed by a loading dose of 5-fluorouracil (5-FU; 400 mg/m^2) IV bolus administered over approximately 2 to 4 minutes on Day 1, then 5- FU (2400 mg/m^2) via ambulatory pump administered for a period of 46 to 48 hours.
16052181|NCT02510118|Drug|XELOX|XELOX is a combination therapy of Oxaliplatin 130mg/ m^2 d1 Intravenous infusion, every 3 weeks. and Capecitabine 1000mg/m^2 bid, days 1-14, every 3 weeks
16052182|NCT02510118|Drug|Placebo ChangTai Keli|According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of dampness stasis type of spleen deficiency will be given placebo ChangTai Keli, twice daily for 26 weeks for lower dosage.
16052183|NCT02510118|Drug|ChangTai Keli|According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of dampness stasis type of spleen deficiency will be given placebo ChangTai Keli, twice daily for 26 weeks for lower dosage.
16052184|NCT02510105|Device|VDR4 ventilator (Intrapulmonary Percussive Ventilation)|
16052185|NCT02510105|Device|CT scan|
16052186|NCT02510105|Device|Servo-i|
16052187|NCT02510105|Device|- Intubation|
16052188|NCT02510105|Device|Ventilation ( with an ICU conventional ventilator)|
16052191|NCT02510066|Device|Acupuncture|Disposable stainless steel filiform needles (40mm in length and 0.30mm in diameter) are inserted perpendicularly into T8-T12 Jiaji (Ex-B2) points bilaterally to a depth of 25 mm. After De Qi sensation is achieved, the handles of needles on homolateral T8 and T12 Jiaji are respectively connected to the Han's acupoint nerve stimulator at a frequency of 2/100 Hz and a current of 1mA with a disperse-dense waveform for 30 minutes.
16052192|NCT02510066|Device|Placebo acupuncture|Placebo acupuncture needles (Dongbang AcuPrime Acupuncture Inc., South Korea) are used on the non-point points at the same level as T8 and T12 Jiaji, 4.5 cun lateral to the posterior median line. The needles with blunt tips are quickly put onto points without inserting into the skin. The needles on homolateral points at the same level as T8 and T12 Jiaji are then connected to the electric stimulator, but with zero frequency and electric current.
16052193|NCT02510053|Drug|Caspofungin|40 patients with suspected/preoperation/confirmed IFI in ICU received Caspofungin
16052194|NCT02510040|Device|Prism|Ground-in or Fresnel prism
16052195|NCT02510040|Other|Orthoptic Exercises|Orthoptic exercises- fusion, convergence, divergence, and others, including computer-based therapy
16052196|NCT02510040|Procedure|Eye Muscle Surgery|"Bilateral medial rectus muscle resection surgery
~Single medial rectus muscle resection surgery
~Recess lateral rectus muscle resection medial rectus muscle surgery
~Bilateral lateral rectus muscle recession surgery
~Single lateral rectus muscle recession surgery
~Bilateral lateral rectus muscle resection surgery
~Single lateral rectus muscle resection surgery
~Recess medial rectus muscle resection lateral rectus muscle surgery
~Bilateral medial rectus muscle recession surgery
~Single medial rectus muscle recession surgery
~Vertical rectus muscle recession surgery
~Vertical rectus muscle mini-tenotomy (snip) surgery"
16052197|NCT02510040|Procedure|Botox Injection|Botulinum toxin injection
16052198|NCT02510027|Other|HPV screening and triage tests|All cervical and/or vaginal specimens are tested for hrHPV using the Cobas® 4800 HPV test. Triage testing will be performed on all participants with a positive HR-HPV test declared consent at recruitment visit: HPV16/18 genotyping, Cobas® 4800 HPV test, HPV16/18/45 genotyping, BD OnclarityTM HPV Assay, OncoE6 Cervical Test, Liquid based cytology with Papanicolaou stain and p16INK4a/ Ki-67 immunostain.
16052199|NCT02510014|Drug|SUBOXONE sublingual film|SUBOXONE (buprenorphine sublingual film) is used for induction therapy on Days -14 to -12. Participants then complete a 4-to-11 day sublingual film dose adjustment at doses ranging from 8 mg to 24 mg sublingual film prior to starting the Treatment Period.
16052200|NCT02510014|Drug|RBP-6000|Injections administered subcutaneously every 28 days on alternate sides of participant's abdomen starting at 300 mg. Subsequent doses of RBP-6000 could be adjusted down to 100 mg with the possibility of adjusting back up to 300 mg based on the medical judgment of the investigator. De novo subjects receive up to 12 injections and roll-over subjects receive up to 6 injections.
16052201|NCT02510001|Drug|PF-02341066|PF-02341066 (Crizotinib) 250mg OD or 200mg BD or 250mg BD Days 1-28 continuously
16052202|NCT02510001|Drug|PD-0325901|PD-0325901 2mg - 8mg BD with Run in Day -7 to Day-1 on Cycle 1 Day1, then Day 1-21 every 28 day cycle.
16052203|NCT02510001|Drug|Binimetinib|Binimetinib 30mg or 45 mg BD either continuously or Days 1-21 every 28 days
16052204|NCT02509988|Dietary Supplement|Study nutritional drink|Study nutritional drink containing a mix of micronutrients, probiotics and myo-inositol.
16052205|NCT02509988|Dietary Supplement|Standard nutritional drink|Standard nutritional drink containing a mix of micronutrients.
16052206|NCT02509975|Device|Prostate artery embolization.|Embolization of the prostatic vasculature with OCL 503 using a microcatheter.
16052207|NCT02509962|Dietary Supplement|Slow sodium tablets|6 g sodium chloride per day over 14 days
16052208|NCT02509949|Drug|Dexmedetomidine|
16052209|NCT02509949|Drug|Saline|
16052210|NCT02509936|Behavioral|Home-based nutrition education|Health promoters will use 24-hour dietary recall information to assess meal frequency and dietary diversity and then provide tailored nutrition coaching to parents.
16052211|NCT02509936|Dietary Supplement|Standard-of-care nutrition support|Subjects will be provided with a standard food ration and with a multiple micronutrient powder dietary supplement (Chispitas)
16052212|NCT02509923|Drug|Z-215 10mg|Z-215 10mg, capsules
16052213|NCT02509923|Drug|Z-215 20mg|Z-215 20mg, capsules
16052214|NCT02509923|Drug|Rabeprazole Sodium 10mg|Rabeprazole Sodium 10mg tablets
16052215|NCT02509923|Drug|Rabeprazole Sodium 20mg|Rabeprazole Sodium 20mg tablets
16052216|NCT02509897|Other|Hypoxic training|Hypoxic training 3 times per week four four weeks
16052217|NCT02509897|Other|Normoxic training|Normoxic training 3 times per week four four weeks
16052218|NCT02509871|Other|Body composition measurement|DXA, impedance
16052219|NCT02509858|Drug|thyroxine|treatment with 50μg of thyroxine once daily for two months.
16052220|NCT02509858|Drug|Placebo|treatment with 50μg of placebo, once daily, for two months.
16052221|NCT02509858|Other|A meal (730kcal, 50%carbohydrate, of which 38% was starch, 40% fat, and 10% protein)|
16052222|NCT02509845|Drug|C16G2|Antimicrobial peptide
16052223|NCT02509845|Other|Placebo|Placebo
16052224|NCT02509832|Device|Cooling + PCI|Cooling with ZOLL Proteus IVTM System before and after Percutaneous Coronary Intervention (PCI)
16052225|NCT02509832|Device|PCI only|Standard of Care for PCI
16052226|NCT02509819|Device|Heel Cushion Material Bulk (foam)|The heel wedge is made of a rubber style urethane foam. Heel wedges of specified heights and durometers will be inserted into the standard shoes, one at a time, during the test session only. The heel wedges used during the test session are made of the same foam as the heel wedges that are used clinically.
16052227|NCT02509806|Drug|Apatinib|Apatinib Mesylate Tablets 500 mg qd p.o.
16052228|NCT02509793|Drug|Tetrabenazine|Xenazine, pill, dose to effect, three times a day, for 12 weeks
16052229|NCT02509780|Other|Vichy|Volunteers will be asked during 3 days to take their usual intake of fluids. For the following 7 days, they will take the usual intake of fluids plus 250 ml of Vichy water at 1 pm. For the following 7 days, they will take the usual intake of fluids plus 250 ml of Vichy water at 7 am and 7 pm. Ph and density measurement of urine will be made three times a day, at 7 am, 2 pm and 8 pm.
16052230|NCT02509767|Drug|Subcutaneous depot medroxyprogesterone acetate|Based on study arm, subjects will either be taught to self-inject or will be administered DMPA sc by qualified clinic personnel.
16052231|NCT02509754|Procedure|Atrial fibrillation catheter ablation|
16052232|NCT02509754|Procedure|Rate control|Composite of optimal medical therapy and device implantation
16052233|NCT02509741|Behavioral|Education|
16052234|NCT02509741|Dietary Supplement|Food replacement|
16052235|NCT02509741|Behavioral|IOT monitoring|
16052236|NCT02509728|Dietary Supplement|choline supplementation|in addition to standard nutrition: enteral supplementation with 30mg/kg choline chloride for 10 days
16052237|NCT02509728|Dietary Supplement|DHA supplementation|in addition to standard nutrition: enteral supplementation with 60mg/kg DHA for 10 days
16052238|NCT02509728|Dietary Supplement|standard nutrition|standard nutrition
16052239|NCT02509715|Procedure|Intraoperative nerve monitoring|Intraoperative nerve monitoring during thyroid surgery
16052240|NCT02509702|Behavioral|Connected to Care|10 health educative SMSs' sent once a month 5 SMS-reminders for follow-up appointment sent on days -14, -7, -1 pre- follow-up appointment, and +1, +7 post follow-up appointment
16052241|NCT02509689|Behavioral|Global Z-Score Neurofeedback Training|"The experimental intervention in this study, Global Z-Score Neurofeedback Training, is a non-pharmacological EEG Biofeedback training process using a specific new technology that allows for the training to be semi-automated and to train based on referencing EEG activity in 19 sites on the scalp, whilst comparing in real time to a database of non-clinical normative EEG data. Subjects will be scheduled to receive 20 treatment sessions of GZNT over a six-week period, aiming for four treatment visits per week, but allowing for some missed appointments due to holidays and duty obligations.
~Training will be conducted for a continuous time which will begin at 10 minutes in the first session, and progress to a maximum of 30 minutes by the sixth or seventh session, and then remain at 30 minutes of training per session for the remainder of the sessions."
16052242|NCT02509676|Other|stretching exercise|dynamic stretching exercises with 5 repetitions, each lasting 45 seconds, for 5 days a week and 3 times a day
16052243|NCT02509663|Procedure|Functional Endoscopic Sinus Surgery|Balloon Sinuplasty uses a small, flexible, balloon catheter to open up blocked sinus passageways and facilitate drainage of the mucus that builds up in patients suffering from frontal sinusitis symptoms. When the sinus balloon is inflated, it restructures and widens the walls of the sinus passageway while maintaining the integrity of the sinus lining.
16052244|NCT02509663|Procedure|Functional Endoscopic Sinus Surgery using rigide instrumentation|"FESS (Functional Endoscopic Sinus Surgery) using rigide instrumentation is conventional therapeutic strategy.
~The procedure works by cutting to remove bone and tissue to enlarge the sinus opening."
16052245|NCT02509663|Device|Sinuplasty balloon|Balloon Sinuplasty uses a small, flexible, balloon catheter to open up blocked sinus passageways and facilitate drainage of the mucus that builds up in patients suffering from frontal sinusitis symptoms. When the sinus balloon is inflated, it restructures and widens the walls of the sinus passageway while maintaining the integrity of the sinus lining.
16052246|NCT02509663|Device|Endoscope|"FESS (Functional Endoscopic Sinus Surgery) using rigide instrumentation is conventional therapeutic strategy.
~The procedure works by cutting to remove bone and tissue to enlarge the sinus opening."
16052247|NCT02509637|Device|Flutter|Flutter is a small device, simple, like a plastic pipe with a mouthpiece at one end and a perforated cover on the other, containing a steel ball resting in a plastic cone inside. When the patient exhales through the flutter expiratory flow causes movement of the ball, creating an oscillatory positive pressure.
16052248|NCT02509637|Other|Chest Compression|Manual chest compression is based on the application of forces resulting from the action of respiratory muscles or physiotherapist manual action in order to increase the alveolar pressure creating a pressure gradient to promote change in pulmonary flow and volume.It consists of vigorous compression of the chest at the beginning of expiration or during expiration.
16052249|NCT02509637|Other|Control|
16052250|NCT02509637|Other|Impulse Oscillometric|"For this measure will be used IOS Jaeger (Jaeger, Wurzburg, Germany). to minimize the effect of the bad positioning of the tongue will use a mouth free-flow, which contains a depressant for keeping the tongue in the mouth soil, stabilizing it and reducing oral resistance. Volunteers will support hands firmly on the cheeks to reduce the effect of oscillation thereof. The measures will be carried out with the volunteer sitting, using nasal, relaxed and your head in neutral clip, breathing normally through the mouthpiece to his lips tightly sealed to prevent air leaks."
16052251|NCT02509637|Other|Dyspnea scale|Dyspnea will be evaluated across the range Medical Research Council (MRC) for use in patients with chronic obstructive pulmonary disease in Brazil.
16052252|NCT02509637|Other|Acceptability and tolerance|patients will complete scales 1-7, 1: extremely and 7: none) on usefulness, ease to understand the instructions, easy to perform the exercises, degree of fatigue and discomfort
16052253|NCT02509637|Device|Pulse oximetry|During therapy the patient will remain monitored with digital oximeter and the information will be recorded before and after the procedures
16052254|NCT02509637|Other|Difficulty sputum|Patients inform the ease or difficulty sputum according to a scale of 1 to 5, where 1 = no difficulty and 5 = extremely difficult.
16052255|NCT02509624|Drug|Selonsertib|6 mg tablets administered orally in fed state
16052256|NCT02509611|Other|Hatha yoga|Yoga programs that were used in previous PD studies will be incorporated into the design of the proposed intervention program. Two yoga experts who are specialized in musculoskeletal/neurological disorders will review the program. The yoga intervention classes will be taught by a Registered Yoga Teacher. The 60 minute long yoga session will be held twice a week for 12 weeks at a community center in St. Louis Park.
16052257|NCT02509598|Drug|Tc99m tilmanocept|A single dose of 0.5 mCi and 50 ug of Tc99m tilmanocept administered intradermally, peritumorally approximately 15 minutes to 8 hours before surgery
16052258|NCT02509598|Drug|Vital Blue Dye (optional)|A single dose 1-3 mL of vital blue dye (1%) administered intradermally at the start of or during surgery (optional, per institution's standard of care).
16052259|NCT02509598|Procedure|Lymph Node Mapping|Intraoperative lymph node mapping will occur 15 minutes to 8 hours after Tc99m tilmanocept injection
16052260|NCT02509585|Drug|Tc99m tilmanocept|A single dose of 2 mCi (74 MBq) and 50 ug of Tc99m tilmanocept administered peritumorally no more than 20 hours before surgery
16052261|NCT02509572|Behavioral|Sexual health screen (SHS)|Decision support for STI screening through a novel sexual health screen
16052366|NCT02508792|Device|LASER PLACEBO|The low level LASER therapy turned off (placebo) will be applied in six different regions of the thight from the dominant limb, before a fatigue protocol using a isokinetic equipment.
16052262|NCT02509559|Drug|propranololhydrochloride|oral administration of one capsule Propanolol-CT 80 mg Filmtabletten (propranololhydrochloride, film-coated tablet encapsulated, 80 mg, single dose) together with 240 ml tap water and blood sampling at time points blank, 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12 h of study days 1 and 3 and urine sampling for 24 h at study days 1 and 3 with subsequent measuring of propranolol and its clinically relevant metabolites
16052263|NCT02509559|Drug|placebo|oral administration of one placebo capsule together with 240 ml tap water and blood sampling at time points blank, 15, 30, 45 min, 1, 2, 3, 4, 6, 8, 10, 12 h of study days 1 and 3 and urine sampling for 24 h at study days 1 and 3
16052264|NCT02509559|Device|Net Station® System and compatible Geodesic Sensor Nets®|Electrocortical activity will be assessed by continuous EEG recording using Net Station® System and compatible Geodesic Sensor Nets® (Electrical Geodesics Incorporated, Eugene, OR, USA), measured at days 1, 3 and 10 of the study. Event related potentials at encoding (late positive potential, LPP) and at retrieval (ERP memory old/new effect) will be computed off-line after acquisition of the data.
16052265|NCT02509559|Device|VITAPORT|Measurement of the skin conductance by VITAPORT (Vitaport EDV Systeme GmbH, Erftstadt, Germany) on study days 1 and 3 at the time points before administration of the study medication, during the psychophysiological measurement and at 4 h. Furthermore, the skin conductance responses will be measured on day 10 during the psychophysiological measurement.
16052266|NCT02509559|Device|ergoselect II 100/200|Performance of an ergometry by ergoselect II 100/200 (ergoline GmbH, Bitz, Germany) on study days 1 and 3 at 120 min. The burden will be the same wattage over 4 min, that corresponds to that of reaching 80% of the maximal heart frequency in the prestudy examination.
16052267|NCT02509559|Device|SpiroScout|Performance of a spirometry (SpiroScout, Ganshorn Medizin Electronic GmbH, Niederlauer, Germany) with measuring of the forced expiratory volume in 1 second (FEV1) on study days 1 and 3 before administration of the study medication and at 120 min.
16052268|NCT02509559|Device|Mobil-O-Graph® PWA|Measurement of pulse waves by Mobil-O-Graph® PWA (I.E.M., Stollberg, Germany) on study days 1 and 3 at the time points -10 min, 20, 40, 60, 80, 120 min, 3, 5, 7, 11 h.
16052269|NCT02509559|Procedure|Saliva collection|Saliva collection will be performed on study days 1 and 3 at time points -10 min, 80 min, 120 min with subsequent measuring of the concentration of α -amylase
16052270|NCT02509546|Drug|8-Chloroadenosine|Given IV
16052271|NCT02509546|Other|Laboratory Biomarker Analysis|Correlative studies
16052272|NCT02509546|Other|Pharmacological Study|Correlative studies
16052273|NCT02509533|Device|V.A.C.®|Patients received V.A.C.® Therapy (KCI medical) after a transplants of leg ulcers.
16052274|NCT02509533|Device|dressing|Patients received usual dressing method (compresses) after a transplants of leg ulcers
16052275|NCT02509520|Dietary Supplement|MPR and High Protein Supplement (HPRO) and Neuromuscular Electric Stimulation (NMES)|The MPR provides strength and cardiopulmonary endurance training, which consist of exercises to promote function movements. Intensity is based on patient's hemodynamic responses and subjective report using Modified Borg Dyspnea Scale. Intensity, duration, or type of activity will be modified each session to achieve a moderately intense physiologic response. The NMES protocol requires self-adhesive surface electrodes be placed on quadriceps muscles and lower leg bilaterally, twice daily. This protocol is based on prior NMES protocols used to stimulate muscle protein synthesis in older diabetic patients, preserve muscle mass in intensive care patients and increase strength in older adults after knee replacement. The HPRO intervention is based on caloric needs, calculated using validated equations to maintain positive nitrogen balance. Protein will be supplemented as isolated amino acids twice/day to deliver ~15g of essential amino acids per serving, with a goal of 1.6 g/kg/day.
16052278|NCT02509494|Biological|Ad26.ZEBOV|Ebola Zaire vaccine, replication incompetent vaccine, sterile suspension of 0.5 milliliter (mL) intramuscular (IM) injection of 5*10^10 viral particles.
16052279|NCT02509494|Biological|MVA-BN-Filo|MVA-BN-Filo- is a non-replicating vaccine, 0.5 mL IM injection of 1*10^8 Infectious Unit (Inf. U.).
16052280|NCT02509494|Biological|MenACWY|MenACWY is a WHO-prequalified Meningococcal Group A, C, W135 and Y conjugate vaccine.
16052281|NCT02509494|Biological|Placebo|0.9% saline for injection.
16052282|NCT02509481|Drug|Ivermectin|
16052283|NCT02509481|Drug|Albendazole|
16052284|NCT02509468|Drug|Sirolimus|"each patient will be followed during a 12-month-period
~each patient will start by an observational period and end being treated by sirolimus
~at a random date (between month 4 and month 8), each patient will switch from the observational period to the sirolimus period"
16052286|NCT02509429|Device|Insulin therapy (aspart, lispro ou glulisine) with Control-to-Range algorithm|The insuline used is usual patient insuline. There is no specific insulin for this protocol
16052287|NCT02509429|Device|Insulin therapy ((aspart, lispro ou glulisine) withThreshold Low Glucose Suspend|The insuline used is usual patient insuline. There is no specific insulin for this protocol
16052432|NCT02508298|Device|Spleen stiffness measurement|As decribed in arm descriptions; performed by ARFI
16052433|NCT02508259|Drug|Suramin|20 mg/kg IV in 50 ml saline over 30 minutes
16052288|NCT02509403|Drug|Essential oils infused Perineal Hygiene wipe|Each participant will be asked to complete a treatment period of one month's duration. At the start of the study, the participants will be asked to fill-out a baseline questionnaire and will be given a month's supply of the perineal hygiene towel with instructions about its use. At day 15, 30 and 45 follow-ups will be conducted.
16052289|NCT02509390|Procedure|Blood samples|Investigators analyze hematological parameters with blood sampled daily in severe trauma patients
16052290|NCT02509377|Procedure|Open Fetal Repair of Myelomeningocele|Open Fetal Repair of Myelomeningocele when mothers BMI is elevated
16052291|NCT02509364|Other|No intervention|
16052292|NCT02509351|Drug|misoprostol|400 microgram of misoprostol is given preoperatively in patients undergoing elective cesarean section
16052293|NCT02509351|Drug|placeboo|women will recive 2 identical tablets as placeboo
16052294|NCT02509338|Device|Electrode deep brain stimulation (Monopolar DBS Lead Model 09064-40cm)|Deep brain stimulation surgery with implantation of one contact-electrode deep brain stimulation electrodes bilaterally in the internal globus pallidum for treating dystonia
16052295|NCT02509325|Device|Parkinson's Kinetigraph|
16052296|NCT02509312|Drug|Ketorolac|Patients in experimental arm will receive ketorolac at time of cord clamp and then for 3 more doses every 6 hours
16052297|NCT02509312|Drug|Epidural Morphine|All patients, including those in both the experimental and control groups, in this study will receive epidural morphine prior to removal of epidural catheter as part of routine obstetric care for cesarean delivery.
16052298|NCT02509312|Drug|Hydromorphone|Post-operatively all patients patients will have intravenous hydromorphone on an as needed basis to control their pain, as part of routine obstetric care for cesarean delivery.
16052299|NCT02509299|Other|Physiotherapy program 1|The standard medical treatment and additionally they will receive physiotherapy. The program will be performed every day during the hospital stay and it will include global active range of motion (ROM) exercises and muscle strengthening like upper and lower limbs flexion-extension do single-leg stance, and sit to stand exercises.
16052300|NCT02509299|Other|Physiotherapy program 2|COPD patients included in this group will receive the standard medical treatment and additionally, they will receive a physiotherapy program. The program will be performed every day during the hospital stay and included neuromuscular stimulation therapy on quadriceps accompanied by lower limbs exercises
16052301|NCT02509299|Drug|Standard medical treatment|"The standard medical treatment consists on:
~Inhaled bronchodilators: Short acting inhaled β2 agonists ( salbutamol and terbutaline) and anticholinergic agents (ipratropium and oxitropium bromide).
~Glucocorticoids:
~Inhaled glucocorticoids including beclomethasone dipropionate, budesonide, flunisolide, fluticasone propionate and triamcinolone acetonide, depending on the expert criteria.
~- Antibiotics: The antibiotics were administered according to the GOLD criteria including the β-lactamase inhibitor and fluoroquinolones."
16052302|NCT02509286|Drug|5-Fluorouracil|2600 mg/m² (24 hours), d1 every two weeks;
16052303|NCT02509286|Drug|Leucovorin|200 mg/m² in 250 ml NaCl 0.9%, d1 every two weeks;
16052304|NCT02509286|Drug|Oxaliplatin|85 mg/m² in 500 ml G5% over 2h, d1 every two weeks;
16052305|NCT02509286|Drug|Docetaxel|50mg/m2 in 250 ml NaCl 0.9% over 1h, d1 every two weeks;
16052306|NCT02509286|Drug|Carboplatin|Dose-dependant: 2mg/ml/min AUC in 500ml Glucose 5%, day 1, 8, 15, 22 and day 29.
16052307|NCT02509286|Drug|Paclitaxel|50mg/m2 in 500ml NaCl 0.9% over 1 h, day 1, 8, 15, 22 and day 29;
16052308|NCT02509286|Radiation|Neoadjuvant radiation|41.4Gy given in 23 fractions of 1.8Gy on days 1-5, days 8-12, days 15-19, days 22-26 and days 29-31.
16052309|NCT02509273|Drug|Clonidine|
16052310|NCT02509273|Drug|Midazolam|
16052311|NCT02509260|Device|Prevena wound management system|Patients will have the Prevena wound management system applied post-operatively.
16052312|NCT02509260|Other|Standard wound dressings|Control patients with standard wound dressings will have gauze and tape dressings applied
16052313|NCT02509247|Device|Telemonitoring|Wireless telemonitoring
16052314|NCT02509234|Drug|Combined chemotherapy with trabectedin followed by irinotecan|"Day 1:
~Trabectedin 1,1 - 1,5 mg/m²/day i.v.
~Day 3-5 and 10-12:
~Irinotecan 30- 90 mg/m²/day p.o. or i.v."
16052315|NCT02509208|Device|SurgiClot haemostatic dressing|haemostatic dressing
16052316|NCT02509195|Drug|Triumeq|Subjects will take the last dose of their current antiretroviral combination at its usual time on the day before the baseline visit (day 1) and will switch on day 1 to Abacavir/lamivudine/dolutegravir 600mg/300mg/50mg (Triumeq) fixed dose combination once daily between day 1 and day 180.
16052317|NCT02509182|Drug|60% oxygen|An inspired oxygen concentration of 60% will be administered during pulmonary lobectomy surgery.
16052318|NCT02509182|Drug|100% oxygen|An inspired oxygen concentration of 100% will be administered during pulmonary lobectomy surgery.
16052319|NCT02509169|Drug|TAE plus P53 gene|Trans-catheter embolization combined with recombinant adenoviral human p53 gene therapy
16052320|NCT02509169|Other|TAE|Trans-catheter embolization
16052321|NCT02509156|Biological|Allo-MSCs|20 transendocardial injections of 0.4ml allo-MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
16052322|NCT02509156|Biological|Placebo|20 transendocardial injections of 0.4ml Buminate solution administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
16052323|NCT02509143|Procedure|High-dose acupuncture with intravenous infusion of ramosetron|"Three sessions of acupuncture will be provided within 48 hours after surgery. Electrical stimulation with an alternating frequency of 2 to 100 Hz will be applied to selected points (PC6 to LI4, ST36 to ST37, and bilateral SP6).
~An embedded acupuncture technique for preoperative anxiety will be applied to the bilateral acupuncture points of Liver (LI4), Heart 7 (HT7), Stomach (ST36), Yin-Tang, ear Shen-Men,and ear sympathetic and will be removed the next day. Treatments will be provided by qualified hospital staff (Korean medical doctors) with more than 10 years of clinical experience. The same stimulation of P6 points and antiemetics will be provided to the P6 acupuncture-point stimulation group."
16052324|NCT02509143|Device|P6 stimulation with intravenous infusion of ramosetron|Stimulation of P6 points will be maintained from one hour before and for 48 hours after surgery by wearing a wristband that produces pulse-type transcutaneous electrical stimulation. Antiemetics will be provided, the same as the standard antiemetic medication alone group.
16052434|NCT02508259|Drug|Saline|50 ml IV over 30 minutes
16052435|NCT02508246|Drug|Cisplatin|Given IV
16052325|NCT02509143|Drug|Intravenous infusion of ramosetron|"Intravenous infusion of (oxycodone 20mg, ketorolac 120mg, ramosetron 0.3mg) as standard antiemetic medication will be provided. A dose of continuous infusion will be reduced by 0.1 ml/hr when a patient complaints of nausea.
~When vomiting occurs, a dose of continuous infusion will be reduced by 0.2 ml/hr and a bolus infusion of ramosetron 0.3 mg will be provided. A bolus infusion of ramosetron 0.3 mg will be also given if a patient feels greater than or equal to six points of nausea as measured on a 0 to 10 numeric rating scale (NRS) (nausea-severity scale) or by the patient's request, regardless of the severity of the nausea."
16052326|NCT02509117|Drug|PF-06751979 single ascending dose|PF-06751979 administered as a single dose (solution/suspension) in cross-over fashion. Each subject may receive up to 4 study treatments (placebo and up to 3 doses of PF-06751979). The dose levels are 3 mg, 12 mg, 40 mg, 160 mg.
16052327|NCT02509117|Drug|Placebo single dose|Matched Placebo solution/suspension administered as single dose.
16052328|NCT02509117|Drug|PF-06751979 multiple ascending dose|PF-06751979 (solution/suspension) administered daily for 14 consecutive days to parallel cohorts. The dose levels are 5 mg, 15 mg, 50 mg.
16052329|NCT02509117|Drug|Placebo multiple dose|Matched Placebo (solution/suspension)administered daily for 14 consecutive days.
16052330|NCT02509117|Drug|PF-06751979 multiple dose|PF-06751979 (solution/suspension) administered daily for 14 consecutive days. The dose level is 50 mg.
16052331|NCT02509117|Drug|PF-06751979 multiple dose|Matched Placebo (suspension/solution) administered daily for 14 consecutive days to parallel cohorts.
16052332|NCT02509104|Drug|FDC capsule of dutasteride and tamsulosin|Each FDC capsule contains a mixture of dutasteride formulation (equivalent to 0.5 mg dutasteride) and tamsulosin (equivalent to 0.2 mg tamsulosin) and its physical appearance is hard shell capsule.
16052333|NCT02509104|Drug|Dutasteride soft gelatine capsule and tamsulosin HCl oral disintegrating tablet|Coadministration of dutasteride soft gelatine capsule and tamsulosin HCl oral disintegrating tablet. Each soft gelatine capsule consist of 0.5 mg of dutasteride and physical appearance is Oblong, size 6, dull yellow capsule. Each oral disintegrating tablet consist of 0.2 mg of tamsulosin and its physical appearance is white, round standard convex.
16052334|NCT02509091|Drug|Bronchoalveolar Lavage and Local Amikacin Injection|injecting 0.4g of AK in 100 ml to 250 ml, not exceeding 300 ml. And generally, repeat it for 3 to 5 times.
16052335|NCT02509078|Drug|Cisatracurium Besylate|Patients randomized to the early neuromuscular blockade arm will receive a cisatracurium besylate bolus of 15 mg, followed by a continuous infusion of 37.5 mg/hour for 48 hours. Patients randomized to the control arm will receive no protocol specified neuromuscular blockade.
16052336|NCT02509065|Device|Bionic Pancreas|Participant wears the bionic pancreas, including an insulin and/or glucagon pump depending on which arm they are in. The 100 mg/dl arm for type 1 diabetes patients will deliver insulin and glucagon. The 100 mg/dl arm for type 2 diabetes patients will deliver just insulin. The 115 mg/dl arm will deliver insulin and glucagon. The 120 mg/dl arm will deliver just insulin. The 145 mg/dl arm will deliver just insulin. The 130 mg/dl and 110 mg/dl arms will deliver insulin and placebo, or insulin and glucagon, and will be double blinded.
16052337|NCT02509065|Other|Usual Care|Participant cares for their diabetes according to their usual practice, with blinded CGM monitoring. No medication will be administered by the study in this intervention.
16052338|NCT02509052|Other|Laboratory Biomarker Analysis|Correlative studies
16052339|NCT02509052|Drug|Leflunomide|Given PO
16052340|NCT02509052|Other|Pharmacological Study|Correlative studies
16052341|NCT02509039|Drug|CC-122|5 continuous days out of 7 days per week intermittent dosing
16052342|NCT02509026|Biological|Etanercept|50 mg subcutaneous, once weekly, 24 weeks
16052343|NCT02509000|Other|air purifier|filtration units randomly allocated to active- and sham-mode in 20 recruited households for four weeks
16052344|NCT02508961|Behavioral|Exercise|web-based physio exercise programme
16052345|NCT02508935|Drug|XARTEMIS XR|XARTEMIS XR [7.5 mg oxycodone hydrochloride and 325 mg acetaminophen (APAP)] Extended-Release Tablets
16052346|NCT02508922|Dietary Supplement|Vitamin D3|2,000iu vitamin D drops will be taken daily for 20 weeks
16052347|NCT02508922|Dietary Supplement|Placebo|Matching placebo drops will be taken daily for 20 weeks
16052348|NCT02508909|Procedure|Videoscopic ilioinguinal dissection|Inguinal dissection is performed after subcutaneous inflation via three ports. Iliac dissection is obtained through a pro-peritoneal access.
16052349|NCT02508896|Biological|AFFITOPE® AT04A+adjuvant|subcutaneous injection
16052350|NCT02508896|Biological|AFFITOPE® AT06A+adjuvant|subcutaneous injection
16052351|NCT02508896|Biological|Adjuvant without active component|subcutaneous injection
16052352|NCT02508870|Drug|Atezolizumab|Participants will receive atezolizumab as per the schedule described in individual cohort.
16052353|NCT02508870|Drug|Azacitidine|Participants will receive azacitidine as per the schedule described in individual cohort.
16052354|NCT02508857|Drug|Ketorolac|Patients received intravenous injection of ketorolac (30 mg) in bolus; then, saline solution was continuously infused during the entire procedure (Group K),
16052355|NCT02508857|Drug|Magnesium|Patients received intravenous magnesium sulfate (20 mg/kg) in bolus, then magnesium sulfate (2 mg/kg/h) was continuously injected during the procedure (Group M)
16052356|NCT02508857|Drug|Saline solution|intravenous saline solution (20 ml) was injected in bolus, followed by continuous infusion of saline solution during the entire procedure (Group S).
16052357|NCT02508844|Dietary Supplement|Vivomixx®|probiotics intake (four capsules of Vivomixx®; total of 450 billion CFU/day) from gestational age 14-20 until delivery
16052358|NCT02508844|Dietary Supplement|Placebo|Four capsules/day from gestational age 14-20 until delivery. The placebo capsule contains microcrytalline cellulose, magnesium stearate and silicon dioxide.
16052359|NCT02508831|Procedure|Double upper limb allograft|Patients with bilateral amputation of upper limb will receive a double upper limb allograft
16052360|NCT02508818|Other|Parabolic flight|
16052361|NCT02508818|Other|Cardiovascular measurements|
16052362|NCT02508805|Drug|Neuromultivit|
16052363|NCT02508805|Drug|Voltaren|
16052364|NCT02508805|Drug|Sirdalud|
16052365|NCT02508792|Device|LASER|Low level LASER therapy will be applied in six different regions of the thight from the dominant limb, before a fatigue protocol using a isokinetic equipment.
16052436|NCT02508246|Drug|Docetaxel|Given IV
16052367|NCT02508779|Behavioral|Bump2be|Bump2be is an internet intervention focusing on six topics (called cores) psycho-educational in nature with the goals of improving individuals' ability to: a) anticipate extreme BG levels, b) detect the presence of extreme BG levels, c) address current extreme BG levels, and d) prevent future extreme BG levels. The program includes didactic information, self-assessment tools, and active learning exercises.
16052368|NCT02508779|Other|Routine Care|Participants will continue to receive care from their clinician.
16052369|NCT02508766|Procedure|Plantar stimulation|The manipulation was performed with the subject in the supine position. The intervention lasted ten minutes and consisted of four stages: 5 glide pressures focused on each interdigital space, that lasted 10 seconds in duration, 5 compression-decompression of each metatarsophalangeal joint, 5 glide pressures applied for 5 seconds each, on the region of metatarsal heads, 5 static pressures applied for 10 seconds each, focused on four points of the sole.
16052370|NCT02508753|Drug|CXA-101/tazobactam|1000/500 mg single IV dose administered over 60 minutes
16052371|NCT02508753|Drug|CXA-101/tazobactam|3000/1500 mg single IV dose administered over 60 minutes
16052372|NCT02508753|Drug|Moxifloxacin|400 mg tablet
16052373|NCT02508753|Drug|placebo|single IV dose of a saline solution administered over 60 minutes plus oral over-encapsulated moxifloxacin placebo tablet administered at the start of infusion.
16052374|NCT02508740|Drug|bevenopran|Single oral dose
16052375|NCT02508727|Other|MRI|
16052376|NCT02508727|Other|3D cardiac ultrasound|
16052377|NCT02508714|Device|Orsiro|stents will be implanted in case of significant coronary artery disease
16052378|NCT02508714|Device|Resolute Onyx|stents will be implanted in case of significant coronary artery disease based on coronary angiography
16052379|NCT02508701|Behavioral|Message X Onsite/Offsite Vaccination|Personal, Altruistic Message vs Generic Message Inside-Dormitory Vaccination vs. Student Health Center Vaccination
16052380|NCT02508688|Procedure|thoracoscopic diaphragmatic repair|patients with refractory hepatic hydrothorax (> 3 times thoracentesis and failure to maximal doses of diuretics) who underwent thoracoscopic diaphragmatic repair
16052381|NCT02508662|Other|Review of Screening Tests and Molecular Test Results|Review of screening tests and molecular test results in participant's medical records. Study staff and study doctor work together to find an off-label use for an FDA approved therapy that is best for participant.
16052382|NCT02508649|Drug|selepressin|
16052383|NCT02508649|Drug|placebo|
16052384|NCT02508636|Drug|Enzalutamide|Given orally
16052385|NCT02508636|Drug|Leuprolide|Given via intramuscular injection
16052386|NCT02508636|Radiation|Intensity-Modulated Radiation Therapy|A total dose of 45 Gy in 25 fractions of 1.8 Gy each.
16052387|NCT02508623|Drug|Rifaximin|Rifaximin 550 mg tablet BID for 60 days
16052388|NCT02508623|Drug|Placebo|Placebo 1 tablet BID for 60 days
16052389|NCT02508597|Other|Physicians receiving smoking cessation training|On the training day, the investigators will explain at the beginning of the workshop the purpose of the training, and the details of the brief smoking cessation intervention to all physicians who attend the training workshop.
16052390|NCT02508584|Biological|anti-mycoplasma hominis antibodies|provision of customized anti-mycoplasma hominis antibodies in the context of a treatment IND.
16052391|NCT02508571|Other|Direct swallowing training (DST)|The DST consists of placing a bolus of 0.05-0.2 mL of formula milk (if the parents refuse, distilled water) via a 1-mL syringe directly on the medial-posterior part of the tongue approximately at the level of the hard and soft palate junction. The volume is started with 0.05 mL, and increased in increments of 0.05 mL to a maximum of 0.2 mL until the swallowing reflex is observed. Once the minimal volume necessary to initiate the swallow reflex is identified, it is used for the duration of the training. The bolus is provided every 30 sec over the 15-minute program or as tolerated. It is continued until infants are able to complete independent oral feeding, 2 days in a row with no adverse events that do not self-resolve.
16052392|NCT02508571|Other|Oral sensorimotor stimulation (OSMS)|The OSMS consists of a 15-minute stimulation program, whereby the first 12 minutes involve stroking the cheeks, lips, gums, and tongue, and the final 3 minutes consist of sucking on a pacifier. It is continued until infants are able to complete independent oral feeding, 2 days in a row with no adverse events that do not self-resolve.
16052393|NCT02508571|Other|Sham intervention|The sham intervention consisted of the therapists placing his/her hands into the incubator or bassinet for 15 minutes without touching the infants. It is continued until infants are able to complete independent oral feeding, 2 days in a row with no adverse events that do not self-resolve.
16052394|NCT02508558|Other|motion perception and locomotor operation performance measurements|
16052395|NCT02508558|Other|parabolic flight|
16052396|NCT02508545|Other|perceived egocentric distance (PED) measurements|
16052397|NCT02508545|Other|Parabolic flight|
16052398|NCT02508532|Drug|Avapritinib|avapritinib tablets
16052399|NCT02508519|Procedure|Acupuncture|An acupuncture needle insertion according to zonal or balance method.
16052400|NCT02508506|Drug|ALKS 5461|Single dose, given orally
16052403|NCT02508480|Behavioral|Photovoice|"The 10-session, peer-led Photovoice program, designed to empower individuals with SMI to confront public prejudice and discrimination and reduce personal stigma (self-stigma and perceived stigma), was developed and pilot tested at our Center, with primary contributions from staff with a lived experience of mental illness.
~In the Photovoice sessions, participants will be given a workbook titled Combating Prejudice and Discrimination through Photovoice Empowerment. Peer leaders will facilitate discussions based on topics in the workbook. Participants will be given cameras and guidance on taking pictures and writing narratives descriptions about the pictures, specifically the ways in which the pictures relate to experiences of prejudice and discrimination."
16052437|NCT02508246|Other|Laboratory Biomarker Analysis|Correlative studies
16052404|NCT02508480|Behavioral|Enhanced Control|The control SAU condition will be enhanced with a 60-minute peer-led manualized educational group session (Leaders' Guidelines and Handout for Participants are attached). It will provide participants with information about the nature of stigma and the laws in the U.S. that protect people with disabilities from discrimination. Participants will be engaged in a discussion about their use of different strategies for proactive coping with psychiatric stigma. This session will be co-led by the same peers who will be delivering the Photovoice program to the experimental group at relevant wave and study sites. Participants randomized to the enhanced Services as Usual control condition will be invited to join a Photovoice group once they complete the final 6-month follow-up assessment.
16052405|NCT02508467|Drug|Fisogatinib (BLU-554)|
16052406|NCT02508441|Drug|Andes-1537 for Injection|"Part 1: Andes-1537 subcutaneous injection, 100 to 1000 mg twice a week per 4-week cycle
~Part 2: Andes-1537 subcutaneous injection, recommended phase 2 dose administered twice a week per 4-week cycle"
16052407|NCT02508428|Device|Hip Replacement with crosslinked Marathon polyethylene|Comparison of Marathon and Enduron polyethylene
16052408|NCT02508428|Device|Hip Replacement with noncrosslinked Enduron polyethylene|
16052409|NCT02508415|Other|Non Surgical Periodontal Therapy|OHE, scaling root planing, mouth wash
16052410|NCT02508402|Drug|Dexamethasone|"The participant of Dexamethasone Group will receive a prefilled syringe with two milliliters (8 mg) of Dexamethasone intramuscular, and the participants of Group II will not receive Dexamethasone or any other cervical ripening agent.
~All the participants in both groups will randomly be assigned by computer list.
~II. After six hours of the initial dose, the labour induction will start via Oxytocin using"
16052411|NCT02508402|Drug|Placebo|two milliliters of normal saline given to placebo group .
16052412|NCT02508389|Drug|Low Dose GC4419: 30mg/day|Low Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
16052413|NCT02508389|Drug|High Dose GC4419: 90mg/day|High Dose GC4419 will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
16052414|NCT02508389|Drug|Placebo|Placebo will be administered by 60 minute IV infusion, within 1 hour prior to daily IMRT fractions, until IMRT is complete (generally M-F for approximately 7 weeks).
16052415|NCT02508389|Radiation|Intensity-Modulated Radiation Therapy|Daily fractions of IMRT (2.0-2.2 Gy) to a total of 60-72 Gy over approximately 7 weeks
16052416|NCT02508389|Drug|Cisplatin|"Administered 80-100 mg/m2 once every three weeks for 3 doses or 30-40 mg/m2 once weekly for 6-7 doses.
~Substitution of other systemic agents due to related toxicities (i.e., carboplatin) would be evaluated to determine eligibility by the Medical Monitor"
16052417|NCT02508376|Other|AP10-602|AP10-602 contains GLA formulated with liposomes and an additional immunological adjuvant. The ID93 (10 mcg) + AP10-602 (5 mcg) arm will receive intervention on days 1, 29 and 57. The ID93 (10 mcg) + AP10-602 (10 mcg) arm will receive intervention on days 1, 29 and 57.
16052418|NCT02508376|Biological|GLA-SE|Glucopyranosyl Lipid A- Stable oil-in-water emulsion (GLA-SE). The ID93 (10 mcg) + GLA-SE (5 mcg) arm will receive intervention on days 1, 29 and 57
16052419|NCT02508376|Biological|ID93|ID93 is a fusion polyprotein comprising four Mtb antigens (Rv2608, Rv3619, Rv3620, Rv1813). All arms will receive 10 mcg ID93 IM on days 1, 29 and 57
16052420|NCT02508363|Behavioral|questionnaires|
16052421|NCT02508350|Drug|Daptomycin|Drug: Daptomycin for Injection（Cubicin,AstraZeneca） dosage: 10-12mg/kg/day frequency: once a day duration: 14 days
16052422|NCT02508350|Other|determination of plasma concentration|A maximum of 12 blood samples (1.5mL) were collected in Ethylenediaminetetraacetic acid disodium salt (EDTA-Na2) tubes over a 6-dose administration sequence.Sampling was done prior to the administration of the first dose, at 30 minutes (end of infusion),and at 4,12,and 24 hours after the initial dose.Additional blood samples were collected at the end of infusion (peak) and prior to the subsequent dose (trough) for doses 2-5.After the sixth dose the blood samples were collected prior to the administration and at 4,and 24 hours after the end of infusion.
16052423|NCT02508337|Drug|XG-102|Comparison of XG-102 versus placebo for the treatment of ocular inflammation and pain associated with cataract surgery
16052424|NCT02508337|Drug|Placebo|Comparison of XG-102 versus placebo for the treatment of ocular inflammation and pain associated with cataract surgery
16052425|NCT02508324|Biological|haplo-identical cells (donor)|Treatment: Haplo-identical healthy related donor. i.e. Parent, child, sibling, possibly third degree or further removed relative (cousin, aunt, nephew etc). They will be collected using standard methods and approximately 3 x10^6 CD34 cells/kg will be infused within 72 hours after completion of the treatment.
16052426|NCT02508324|Biological|umbilical cord blood unit (CBU)|Treatment: The CBU unit must supply a minimum of 0.5 x107/kg and a maximum of 2.5x107/kg nucleated cell dose pre-cryopreservation. The unit must match at a minimum of 4 of 6 at HLA-A, -B antigens, -DRB1 alleles with the recipient. Mismatches (0-2) can be at any loci -. Although molecular level typing will be available for the patient and the CBU unit, a match is defined at intermediate resolution for HLA-A and -B and at high resolution for -DRB1. The CBU donor will also have undergone HLA typing of the mother, thus allowing determination of the CBU-IPA and NIMA. CBU grafts used in this study will be investigational units that meet all criteria for clinical use. Better matching units will be preferred over less matching units as long as the CBU dose exceeds 0.5 x107 nucleated blood cells/kg
16052427|NCT02508311|Drug|Oral Albuterol Extended Release|Subjects will receive extended release Albuterol, 4mg twice daily for the first week. The remaining 15 weeks subjects will receive extended release Albuterol, 8mg twice daily.
16052428|NCT02508311|Drug|Placebo|Subjects will receive placebo tablets twice daily for 16 weeks.
16052429|NCT02508298|Procedure|HVPG|HVPG will be performed by placing a placing a 7F venous catheter into a supra-hepatic vein and then advancing a 5F balloon-tipped catheter into the right hepatic vein. Wedged hepatic venous pressure (WHVP) and free hepatic venous pressure (FHVP) will be measured by connection to an external transducer and polygraph (PowerLab, ADInstruments Inc., Colorado Springs, CO). After inflating the balloon catheter, adequacy of the occlusion will be established by injection of a small amount of radiologic contrast medium. Hepatic Venous Pressure gradient (HVPG) will be calculated as the difference between WHVP and FHVP.
16052430|NCT02508298|Drug|Indocyanine Green Retention test|As decribed in arm descriptions
16052431|NCT02508298|Device|Liver stiffness measurement|As decribed in arm descriptions; perfromed by ARFI
16052439|NCT02508246|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16052440|NCT02508246|Drug|WEE1 Inhibitor AZD1775|Given PO
16052441|NCT02508220|Drug|Syntocinon|Oxytocin nasal spray
16052442|NCT02508220|Drug|Placebo|distilled water in nasal spray
16052443|NCT02508207|Drug|Tezacaftor/Ivacaftor|Tezacaftor/Ivacaftor FDC
16052444|NCT02508207|Drug|Ivacaftor|
16052445|NCT02508207|Drug|Tezacaftor/Ivacaftor matching placebo|
16052446|NCT02508207|Drug|Ivacaftor matching placebo|
16052447|NCT02508194|Biological|MEDI7510|RSV soluble fusion protein (sF) antigen plus glucopyranosyl lipid A in stable emulsion (GLA-SE) adjuvant
16052448|NCT02508194|Biological|IIV|Marketed Inactivated Influenza Vaccine
16052449|NCT02508194|Other|Placebo|Sterile Saline
16052450|NCT02508181|Device|I-gel|supraglottic airway device without cuff
16052451|NCT02508181|Device|LMA Supreme|supraglottic airway device with cuff
16052452|NCT02508168|Drug|Alogliptin|Alogliptin 12.5 mg tablets
16052453|NCT02508168|Drug|Metformin Hydrochloride|Metformin hydrochloride 1000 mg tablets
16052454|NCT02508168|Drug|SYR-322MET|SYR-322MET (alogliptin 12.5 mg and metformin 1000 mg) fixed-dose combination (FDC) tablets
16052455|NCT02508155|Biological|MEDI7352 for IV infusion|MEDI7352 for IV infusion
16052456|NCT02508155|Biological|Placebo for IV infusion|IV Placebo infusion
16052457|NCT02508155|Biological|MEDI7352 for Subcutaneous Injection|MEDI7352 for subcutaneous injection
16052458|NCT02508155|Biological|Placebo for Subcutaneous Injection|Subcutaneous Placebo Injection
16052459|NCT02508142|Drug|Hyoscine-N-Butylbromide|"Study Drug: 20 mg/2 mL Hyoscine-N-Butylbromide in 98 mL normal saline (totally 100 mL) ıntravenous form of Hyoscine-N-Butylbromide in normal saline is in the same appearance with placebo Study drug: 100 mL normal saline (placebo) (totally 100 mL)
~Drug: Fentanyl 1 mcg/kg as rescue analgesia at 30th minute"
16052460|NCT02508129|Behavioral|Brief Behavioral Treatment for Insomnia|BBTI employs behavioral strategies for treating insomnia, including stimulus control and sleep restriction. The BBTI interventionist contacts occur by telephone or web conferencing. It is administered in an initial session, followed by 3 brief weekly contacts, each guided by a printed workbook. During an initial 60 minute session, the sleep interventionist will review the participant's insomnia symptoms, discuss sleep regulation, and develop an individualized prescription of sleep wake times.
16052461|NCT02508129|Behavioral|Sleep Healthy Using the Internet|"SHUTi is a self-guided, automated, interactive, and tailored web-based program modeled on the primary tenets of Cognitive Behavioral Treatment for Insomnia (CBT-I): sleep restriction, stimulus control, cognitive restructuring, sleep hygiene, and relapse prevention. Intervention content is metered out over 6 Cores based on a time and event-based schedule. SHUTi uses online sleep diaries to track progress and to tailor treatment (e.g., assign a sleep restriction window). Each Core acts as an online analog for the weekly sessions of traditional CBT-I and follows the same structure."
16052462|NCT02508129|Behavioral|Enhanced Usual Care|Participants randomized to EUC will complete the standard panel of self-report assessments and home blood pressure monitoring at baseline. The study team will generate an individualized report based, which will be sent to the participant and physician. The report will also contain publically-available educational resources (websites, books) and contact information for treatment resources. Participants in EUC will be given a link to a website containing an educational video on insomnia and its treatment, produced by Emmi Solutions, Inc. Participants in EUC will complete outcome assessments on the same schedule as participants in the other conditions. Participants who complete the EUC intervention will be offered the CBT-I/ SHUTi intervention following study completion.
16052463|NCT02508116|Genetic|CYP2C19 genotyping|The study utilizes a genotyping device, SpartanRx™ (Spartan Bioscience, Ottawa, Canada) that provides identification of a patient's CYP2C19 *2, *3, and *17 genotypes determined from genomic DNA from a buccal swab sample with 1 hour turnaround time
16052464|NCT02508103|Drug|Oxytocin|Intranasal Oxytocin spray (40 IU, 3x/day) self-administered during laboratory testing session and then for 4-5 days until menses begins
16052465|NCT02508103|Drug|Placebo|Intranasal Placebo spray (3x/day) self-administered during laboratory testing session and then for 4-5 days until menses begins
16052466|NCT02508077|Drug|Fluorouracil|Given IV
16052467|NCT02508077|Drug|Irinotecan Hydrochloride|Given IV
16052468|NCT02508077|Other|Laboratory Biomarker Analysis|Correlative studies
16052469|NCT02508077|Drug|Leucovorin Calcium|Given PO
16052470|NCT02508077|Biological|Panitumumab|Given IV
16052471|NCT02508064|Drug|BMS-663068|BMS-663068
16052472|NCT02508051|Behavioral|Article email links|Email links to specific articles, published in 2 journals M-Fr with a reminder to take the same test every six month
16052473|NCT02508051|Behavioral|Blog email links|Emailed web links to blog posts M-Fr based on the same articles as in Email links group; each blog post will focus on a specific article with links to the corresponding article. Every six months group 3 will get a reminder to take the same test.
16052476|NCT02508025|Other|Functional Capacity Evaluation|Assessment of work related physical capacity
16052477|NCT02508012|Other|Immuno monitoring|treatment optimization
16052478|NCT02507999|Device|Flotrac|Flotrac guided intervention
16052479|NCT02507986|Device|Single lead ECG device|The single lead ECG device is a smartphone compatible handheld device that produces a single lead ECG after 30 seconds of measurement. It is non-invasive, electrically safe and easy to use.
16052480|NCT02507986|Device|7-Day Holter monitor.|The Holter is a conventional 7-Day Holter monitor.
16052528|NCT02507609|Other|Moderate neuromuscular blockade|TOF count is maintained to 1 to 2 by intermittent intravenous injection of rocuronium bromide 5 mg during operation
16052529|NCT02507609|Other|Deep neuromuscular blockade|PTC is maintained to 1 to 2 degree by continuous infusion of rocuronium bromide intravenous route
16052481|NCT02507973|Other|Airway Pressure Release Ventilation|Airway pressure release ventilation (APRV) is a mode of mechanical ventilation that switches between high (PHigh) and low (PLow) continuous positive airway pressure while allowing spontaneous breathing at both phases. Alveolar recruitment and oxygenation occur during PHigh whereas ventilation occurs during brief releases to PLow.
16052482|NCT02507973|Other|Low Tidal Volume Ventilation|After enrollment and collection of baseline Intracranial pressure and hemodynamic status for 30 minutes the participants will undergo low tidal volume mechanical ventilation (LOTV), serving as a control mode of ventilation. LOTV is most commonly used for trauma patients with lung injury. LOTV provides oxygen in smaller amounts, without overstretching the lungs
16052483|NCT02507960|Device|The Gamma Pod|Immobilization of breast during radiation.
16052484|NCT02507960|Device|CT simulation|See arm description
16052485|NCT02507934|Device|Lubricin|Lubricin 150 µg/ml eye drops
16052486|NCT02507934|Device|Sodium Hyaluronate|Sodium hyaluronate 0.18% eye drops
16052487|NCT02507895|Device|MI-BCI|Subjects will be seated comfortably in front of a computer screen. An EEG cap will be comfortably worn over the head of the subject to record EEG traces of any activated cortical areas. If subjects are able to activate the device and are agreeable to participate in the second phase of the study, they will be enrolled in a 4-week BCI-MI training program of 12 sessions. Subjects will be required to perform 160 trials of MI altogether with assigned rest periods (5 mins) every 40 trials. Each session will last approximate 45 minutes excluding set up time.
16052488|NCT02507882|Biological|IL28B Polymorphism|SNP rs12979860 and 4803217 will be determined in whole blood by allelic discrimination using specific probes by real time PCR.
16052489|NCT02507882|Biological|miRNA quantification|"RNAs will be extracted from serum using miRNeasy Mini Kit (Quiagen) according to the manufacturer's instruction.
~The RNA purity will be assessed by the RNA concentration and quantified by NanoDrop ND-1000 (Nanodrop, United States).
~cDNA will be obtained by miScript II Reverse Transcription Kits (Quiagen) A Preamplification will be performed using miScript PreAMP PCR Kits (Quiagen) Real Time PCRarray will be done using miScript miRNA PCR Arrays, with SYBR Green PCR Master Mix (Quiagen)."
16052490|NCT02507869|Behavioral|Positive affective response|Participants adjust the intensity of their exercise to maintain a pleasant affective response.
16052491|NCT02507869|Behavioral|Moderate-intensity heart rate|Participants adjust the intensity of the exercise to maintain a heart rate in the moderate range (64-76% of their HRmax).
16052492|NCT02507843|Drug|Cholecalciferol|Oral Cholecalciferol(100000 IU) will be administered in Vitamin D group monthly for 6 months.
16052493|NCT02507843|Drug|Placebo|Placebo will be administered in placebo group monthly for 6 months.
16052494|NCT02507817|Other|blood sample and tissue sample|"Maternal LIF levels prior and after delivery.After birth and disconnection of the cord, we also will take a blood sample from the umbilical cord (5cc) for cytokine ELISA testing.
~A small sample of the placenta will be examined in order to assess the level of ACTH protein"
16052495|NCT02507804|Other|Patient diary PROMs|
16052496|NCT02507804|Other|Counselling|
16052497|NCT02507791|Other|Fitbit Charge HR plus weekly phone calls to review physical activity data|Patients during weekly Healthy Kids, Healthy Weight classes will also upload their Fitbit data, which will be remotely accessed by the study team and weekly phone calls will be implemented to discuss activity
16052498|NCT02507778|Device|CellCollectorTM (Gilupi, Germany) needle|needle will be inserted before and after biopsy and will measure circulating tumor cells.
16052499|NCT02507765|Other|Laboratory Biomarker Analysis|Correlative studies
16052500|NCT02507765|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
16052501|NCT02507765|Procedure|Transarterial Chemoembolization|Undergo TACE
16052502|NCT02507739|Other|no possibility to walk during labor|
16052503|NCT02507739|Other|possibility to walk during labor|
16052504|NCT02507726|Device|Flexima Active soft convexe|The Investigational Device will be used during 14 +- 3 days.
16052505|NCT02507700|Procedure|Popliteal block|In group P, popliteal block will be performed with ultrasound guidence.
16052506|NCT02507700|Drug|Sevoflurane|Sevoflurane will be used to all patient's for anesthesia induction and maintenance
16052507|NCT02507700|Device|Ultrasound|For recognize the nerve (sciatic nerve), ultrasound will be used in group P.
16052508|NCT02507700|Other|Plaster cover|Plaster cover will be used to control group for sham procedure
16052509|NCT02507700|Drug|bupivacaine|Bupivacaine 0.25% will be performed for popliteal block to group P.
16052510|NCT02507700|Other|Laryngeal mask airway|After anesthesia induction, laryngeal mask airway will be inserted to all patients
16052511|NCT02507687|Drug|Bimatoprost SR|Up to two Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).
16052512|NCT02507687|Drug|Sham Bimatoprost SR|Up to two Sham Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).
16052513|NCT02507687|Procedure|Selective Laser Trabeculoplasty|Selective Laser Trabeculoplasty administered on Day 1.
16052514|NCT02507687|Procedure|Sham Selective Laser Trabeculoplasty|Sham Selective Laser Trabeculoplasty administered on Day 1.
16052515|NCT02507674|Device|ultrasound|
16052516|NCT02507661|Drug|preservation of alveolar ridge with beta tricalcium phosphate + collagen - 2 months|
16052517|NCT02507661|Drug|no-preservation of alveolar ridge - 2 months|
16052518|NCT02507661|Drug|preservation of alveolar ridge with beta tricalcium phosphate + collagen - 4 months|
16052519|NCT02507661|Drug|no-preservation of alveolar ridge - 4 months|
16052520|NCT02507661|Procedure|preservation of alveolar ridge with beta tricalcium phosphate + collagen - 9 months|
16052521|NCT02507661|Drug|no-preservation of alveolar ridge - 9 months|
16052522|NCT02507648|Drug|Oseltamivir|1 tablet contains 75 mg oseltamivir
16052523|NCT02507648|Drug|Tamiflu®|1 tablet contains 75 mg oseltamivir
16052524|NCT02507635|Drug|Levocetirizine|administration of Levocetirizine 5 mg/day for 4 weeks
16052525|NCT02507635|Drug|Desloratadine|administration of Desloratadine 5 mg/day for 4 weeks
16052526|NCT02507622|Other|measurement of the concentration of C02, CO and NH4, 3 exhaled gas with E-Nose system|
16052527|NCT02507622|Other|Parabolic flight|
16052530|NCT02507596|Biological|Nano-crystalline hydroxyapatite silica gel|it is a type of synthetic bone graft.
16052531|NCT02507596|Procedure|open flap debridement|a periodontal surgical procedure for the purpose of debridement.
16052532|NCT02507583|Drug|IGF-1R/AS ODN; Surgery with tissue harvest and implantation 20 diffusion chambers in the rectus sheath with IGF-1R/AS ODN within 24 hours of craniotomy, implanted for 48 hours.|
16052533|NCT02507570|Drug|Enzalutamide|used concomitantly
16052534|NCT02507570|Radiation|Radium ra 223 dichloride|
16052535|NCT02507544|Drug|TRX-818 capsules|
16052536|NCT02507531|Device|NeXsys Embolization System|Woven metallic mesh placed in aneurysm fundus
16052537|NCT02507518|Procedure|PET scan imaging|a PET scan will be done 2 weeks before the start of maintenance therapy and another 16 days after to predict the earlier response to treatment
16052538|NCT02507505|Procedure|Regional Anesthesia|Regional anesthesia involves temporarily numbing parts of the body with nerve blocks. Spinal anesthesia is a type of regional anesthesia that uses medications injected into the fluid surrounding the spinal cord to temporarily numb the legs and lower abdomen. Spinal anesthesia is the most widely used type of regional anesthesia for hip fracture surgery. While intravenous sedation is typically used for comfort with spinal anesthesia, invasive airway interventions are not typically required.
16052539|NCT02507505|Procedure|General Anesthesia|General anesthesia uses injected or inhaled medications to keep people unconscious during surgery. Since general anesthesia depresses breathing and impairs protective airway reflexes, invasive airway interventions such as breathing tube placement and mechanical ventilation are usually required.
16052540|NCT02507492|Drug|RM-493|
16052541|NCT02507479|Drug|Thiotepa|Chemotherapy given prior to allogeneic stem cell transplantation
16052542|NCT02507466|Behavioral|exercise|Variable conditions of stepping practice
16052543|NCT02507453|Other|parabolic flight|
16052544|NCT02507453|Other|mass/weight perception estimation|estimate the mass/weight perception, expressed by verbally report the absolute and relative mass of the object using a scale from 1 to 10 (1 being light and 10 being heavy)
16052545|NCT02507453|Device|ESA short-arm human centrifuge (SAHC)|
16052546|NCT02507440|Drug|Lidocaine|Prior to initiation of anesthesia viscous lidocaine or placebo will be administered.
16052547|NCT02507440|Drug|Placebo|Prior to initiation of anesthesia viscous lidocaine or placebo will be administered.
16052548|NCT02507440|Drug|Propofol|All patients will receive intravenous propofol as anesthesia for EGD
16052549|NCT02507427|Device|NIM-Eclipse|Using NIM-Eclipse, nerve monitoring and mapping are performed
16052550|NCT02507414|Other|Blood samples|15 arterial blood samples (pre-, intra- and one day postoperatively); no more than 180ml in total over two days.
16052551|NCT02507414|Other|Measurement of microcirculation|Measurement of microcirculation with Laser Speckle Contrast Imaging (non-touch setup with no side effects); continuous measurement of the microvascular blood flow on the forehead up to 60 minutes starting one minute before the surgical procedure.
16052552|NCT02507414|Other|Head down tilt|"At three different time points the participants will be head down tilted in 20 degrees.
~End of surgery (A) One hour postoperatively (B) 18 hours postoperatively (C)"
16052553|NCT02507388|Drug|Brolucizumab 3 mg/50 μL|Administered as an intravitreal injection
16052554|NCT02507388|Drug|Brolucizumab 6 mg/50 μL|Administered as an intravitreal injection
16052555|NCT02507375|Drug|Erlotinib|Erlotinib will be administered as oral tablets.
16052556|NCT02507375|Drug|Pertuzumab|Pertuzumab will be administered as intravenous (IV) infusion.
16052557|NCT02507362|Radiation|adjusted corneal collagen cross-linking|UV-A irradiation for 7 minutes
16052558|NCT02507362|Radiation|accelerated corneal collagen cross-linking|UV-A irradiation for 10 minutes
16052559|NCT02507362|Drug|riboflavin 0.1% combined with dextran 20 %|after mechanical epithelial removal riboflavin drop will be instilled every 5 minutes for 30 minutes and then instillation will be continued during irradiation
16052560|NCT02507362|Procedure|epithelial debridement|corneal epithelium will be removed by a cottons swab
16052561|NCT02507349|Behavioral|Person-Centered Care|Decision support center staffed by peers. Patient uses the CommonGround program prior to medication visit to prepare a personal report, with support from peer(s). The CommonGround report expresses goals for medication, how other strategies help with functioning, current problems, and medication side effects. Patient brings report into the medication visit. Prescriber and patient discuss medication options, and prescriber enters the shared decision into CommonGround during the visit.
16052562|NCT02507349|Behavioral|Measurement-Based Care|Clinic staff asks each patient to use a tablet computer to complete a brief assessment of symptoms and problems prior to medication visit. Prescriber views assessment results on office computer and discusses next steps in medication management with the patient.
16052563|NCT02507336|Drug|Thalidomide|100-300 mg capsule taken by mouth once daily.
16052564|NCT02507323|Drug|ticagrelor|A platelet aggregation inhibitor
16052565|NCT02507323|Drug|prasugrel|a thienopyridine class inhibitor of platelet activation and aggregation
16052566|NCT02507323|Drug|Placebo|placebo
16052567|NCT02507310|Other|thermostat|ambient temperature as modified by thermostat
16052568|NCT02507297|Device|Positive Airway Pressure (PAP)|Positive airway pressure therapy entails use of a machine that blows pressurized room air through the airway (via a mask or nasal pillows, worn on the face) at a sufficient pressure to keep the upper airway open. The pressurized air acts as a splint. Participants randomized to PAP treatment will be offered PAP therapy using an auto-titrating device.
16052569|NCT02507284|Drug|SRX246|
16052570|NCT02507284|Drug|Placebo|
16052571|NCT02507271|Other|Brain Fitness Program|This intervention involves work on a computer by responding to sounds for five hours a week, approximately one hour a day five days a week at the Rusk Institute for Rehabilitation.
16052572|NCT02507271|Other|Weekly Telephone Contact|This intervention involves weekly telephone calls over a period of approximately 8 weeks to inquire about the participant's involvement in cognitively stimulating activities (such as reading, working on the computer, puzzles, etc.)
16052573|NCT02507258|Device|PROFEMUR® Am Femoral Stem w/ PROCOTYL® O Shell|PROFEMUR® Am cementless stems with PROCOTYL® O HA Coated Acetabular Component
16052723|NCT02506192|Drug|Delayed-Release Prednisone|Delayed-Release Prednisone oral tablets (2x5mg) daily for 8 weeks
16052574|NCT02507245|Drug|Growth Hormone-Releasing Hormone|From Baseline Visit (T0) to 6th Month Visit 0,025 mg/kg Growth Hormone/die. From 6th Month Visit to 12th Month Visit 0,030 mg/Kg Growth Hormone/die.
16052575|NCT02507232|Device|NovoTTF-200A|12 cycles
16052576|NCT02507232|Drug|Temozolomide|50 mg/m2/day rounded to the nearest 5 mg. One cycle is 28 days and will be given for 12 cycles
16052577|NCT02507219|Drug|Ibuprofen|On the day of sessions 2-4, subjects will receive either placebo, 200 mg of ibuprofen or 600 mg of ibuprofen after signing the consent form for this study in a randomized, double-blind, counter balanced order. Each study session will occur 1-2 weeks following the previous session. Ibuprofen will be capsuled, and identical placebo capsules will be produced.
16052578|NCT02507206|Drug|DAR 0-100A|15 mg DAR 0100A is dissolved in 150 cc NS administered over 30 minutes intravenously.
16052579|NCT02507206|Drug|Placebo|15 mg DAR placebo is dissolved in 150 cc NS administered over 30 minutes intravenously.
16052580|NCT02507193|Procedure|Open reduction internal fixation|An incision is made at the site of the break or injury, and the fracture is carefully re-aligned . The plate and screws are installed, and the incision is closed with staples or stitches. Synthes and Stryker plate and screws will be used.
16052581|NCT02507193|Procedure|Intermedullary Nail|An incision is made at the site of the break or injury, and the fracture is carefully reduced. The nail in inserted through the medullary canal after proper imaging for accurate placement. The incision is closed with staples or stitches. Acumed fibula nail will be used.
16052582|NCT02507180|Other|LEFt clinical decision rule|"The LEFt rule
~Predictor Points Left leg symptoms +1 Extremity swelling (≥ 2 cm difference in calf circumference +1 First trimester symptom onset +1
~Clinical probability Unlikely: 0 or 1 point Likely: > 1 point"
16052583|NCT02507167|Dietary Supplement|mixed meal|250 ml Fortimel compact (chocolate)
16052584|NCT02507167|Drug|Rifampin|oral rifampin administration (600 mg EREMFAT®)
16052585|NCT02507154|Drug|Cetuximab + NK cells|
16052586|NCT02507141|Device|Reflectance Confocal Microscopy|Reflectance Confocal Microscopy imaging will be performed during surgery. The imaging procedure is expected to last no more than 15-20 minutes. The approach will be essentially similar to the imaging of skin cancer on patients, which is routinely performed in our Dermatology Service.
16052587|NCT02507128|Drug|liraglutide|Liraglutide were taken 30 min before PCI.
16052588|NCT02507128|Drug|placebo|Placebo were taken 30 min before PCI.
16052589|NCT02507115|Behavioral|TMAP|Text messages for Alcohol Risk Reduction
16052590|NCT02507115|Behavioral|Mojo Texts|Motivational texts not alcohol related
16052591|NCT02507102|Device|Voyager|Non-invasive RFE therapy
16052592|NCT02507089|Behavioral|Tailored sleep health education materials.|Tailored sleep health materials.
16052593|NCT02507089|Behavioral|Generic sleep health education materials.|
16052594|NCT02507076|Drug|isolated limb perfusion|Undergo ILP with melphalan
16052595|NCT02507076|Drug|melphalan|Undergo ILP with melphalan
16052596|NCT02507076|Procedure|quality-of-life assessment|Ancillary studies
16052597|NCT02507063|Procedure|ultrasound|Ocular ultrasound to look at the optic nerve sheath diameter in patients with an intracranial monitoring device or with a ventriculoperitoneal shunt malfunction requiring revision
16052598|NCT02507050|Drug|Ivabradine|To start Ivabradine 6 weeks prior to PCI.
16052599|NCT02507037|Dietary Supplement|gum+PEG|chew sugarless gum
16052600|NCT02507037|Drug|polyethylene glycol|2L PEG
16052601|NCT02507024|Other|Online questionnaire|
16052602|NCT02507011|Drug|Carvedilol|Beta-adrenergic receptor blocker
16052603|NCT02507011|Drug|Placebo|Placebo
16052604|NCT02506998|Biological|DLE|Adjuvant treatment
16052605|NCT02506998|Other|Second generation anti histamines + Nasal corticosteroids|Standard treatment
16052606|NCT02506985|Drug|rivaroxaban|Immediately following completion of alteplase infusion, patients will receive rivaroxaban 15 mg oral bid for 21 days followed by 20 mg oral daily.
16052607|NCT02506985|Drug|warfarin|Immediately following completion of alteplase infusion, patients will continue on unfractionated heparin or low-molecular weight heparin with initiation of warfarin adjusted to INR of 2-3.
16052608|NCT02506972|Other|Classic Quaker Quick Oats|Various doses of oats without or with sugar
16052609|NCT02506972|Other|Cream of Rice Cereal|Various doses of cereal without sugar
16052610|NCT02506959|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo autologous peripheral blood stem cell transplant
16052611|NCT02506959|Drug|Busulfan|Given IV
16052612|NCT02506959|Drug|Gemcitabine Hydrochloride|Given IV
16052613|NCT02506959|Other|Laboratory Biomarker Analysis|Correlative studies
16052614|NCT02506959|Drug|Melphalan|Given IV
16052615|NCT02506959|Drug|Panobinostat|Given PO
16052616|NCT02506959|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo autologous peripheral blood stem cell transplant
16052617|NCT02506959|Other|Pharmacological Study|Correlative studies
16052618|NCT02506933|Other|Laboratory Biomarker Analysis|Correlative studies
16052619|NCT02506933|Biological|Multi-peptide CMV-Modified Vaccinia Ankara Vaccine|Given IM
16052620|NCT02506933|Other|Placebo|Given IM
16052621|NCT02506920|Dietary Supplement|Six different types of fat in a meal in random order|Oral fat tolerance test
16052622|NCT02506894|Drug|Magnesium Sulfate|magnesium sulfate will be given for 24 hours
16052623|NCT02506894|Other|0.9% sodium chloride solution|normal saline will be given as intravenous drip over 24 hours
16052624|NCT02506881|Drug|Darbepoetin alfa|
16052625|NCT02506868|Drug|Darbepoetin alfa|Weekly sc administration of darbepoetin alfa
16052626|NCT02506855|Drug|Ropivacaine|
16052627|NCT02506855|Other|Placebo|
16052628|NCT02506855|Procedure|Transversus Abdominis Plane Block|
16052629|NCT02506842|Drug|nab-paclitaxel|Patients firstly receive nab-paclitaxel 100 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats until there is disease progression or recurrence.
16052630|NCT02506842|Drug|gemcitabine|Patients secondly receive gemcitabine 1000 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats until there is disease progression or recurrence.
16053052|NCT02503722|Other|Pharmacological Study|Correlative studies
16052631|NCT02506842|Drug|oxaliplatin|Patients receive oxaliplatin 85 mg/m^2 (iv, 2 hours) on days 8 and 22 with 42 days as a cycle. Treatment repeats until there is disease progression or recurrence. Oxaliplatin is given before folinic acid and fluorouracil when the three drugs are given on the same days.
16052632|NCT02506842|Drug|folinic acid|Patients receive folinic acid 200 mg/m^2 (iv) on days 1, 8, 15 and 22 for 4 weeks, followed by 2 weeks without treatment. Treatment repeats until there is disease progression or recurrence.
16052633|NCT02506842|Drug|fluorouracil|Patients receive fluorouracil 2000 mg/m^2 (iv, 24 hours) on days 1, 8, 15 and 22 for 4 weeks, followed by 2 weeks without treatment. Treatment repeats until there is disease progression or recurrence.
16052634|NCT02506829|Behavioral|Smoking cessation counseling (Quitline)|
16052635|NCT02506829|Behavioral|Smoking cessation pharmacotherapy (e.g, nicotine replacement therapy)|
16052636|NCT02506829|Behavioral|Financial incentives|
16052637|NCT02506816|Drug|Olaparib|Drug exposure has a limited duration 28 (+/- 5) days and at lower dose (600mg/day) than therapeutical accepted (800mg/day).
16052638|NCT02506803|Drug|NAC-GEMABR|NAC-GEMABR regimen includes gemcitabine 1000mg/m2 plus nab-paclitaxel 125mg/m2 3 times weekly 1week rest.
16052639|NCT02506790|Drug|metformin|
16052640|NCT02506790|Drug|Melatonin|
16052641|NCT02506790|Drug|Toremifene|
16052642|NCT02506777|Drug|metformin|
16052643|NCT02506777|Drug|Fluoruracil|
16052644|NCT02506777|Drug|Doxorubicin|
16052645|NCT02506777|Drug|Cyclophosphamide|
16052646|NCT02506777|Drug|melatonin|
16052647|NCT02506751|Drug|liothyronine|All eligible subjects will be treated with the study drug as per the standardized dose-escalation protocol. Subjects will be required to report to the study site every six weeks for the duration of the study in order to receive their study drug and to monitor drug safety and tolerability.
16052648|NCT02506738|Device|Intervention using mHealth|Patients in the intervention used at home a mobile system to monitor their clinical and health status.
16052649|NCT02506725|Other|prenatal care in groups|We will do prenatal care in groups using centering care pregnancy methodology
16052650|NCT02506712|Device|SmartDrive assisting device|oxygen consumption
16052651|NCT02506712|Device|Standard manuel wheelchair|oxygen consumption
16052652|NCT02506699|Other|analgesic effect of rTMS|
16052653|NCT02506686|Drug|Meropenem|Meropenem i.v.
16052654|NCT02506673|Device|Zeiss, Cinema ProMED (audiovisual equipment)|
16052655|NCT02506673|Drug|Midazolam|
16052656|NCT02506673|Device|Skin Conductance Monitor|
16052657|NCT02506660|Drug|Bupivacaine|
16052658|NCT02506660|Drug|Perineural dexamethasone|Dexamethasone in nerve block
16052659|NCT02506660|Drug|Intravenous dexamethasone|
16052660|NCT02506660|Drug|Intravenous saline|
16052661|NCT02506660|Drug|Perineural saline|Saline in nerve block
16052662|NCT02506647|Drug|Gan & Lee insulin glargine followed by Lantus|0.4 IU/kg Gan & Lee insulin glargine injection SC, Lantus 0.4 IU/kg injection SC
16052663|NCT02506647|Drug|Lantus followed by Gan & Lee insulin glargine|Lantus 0.4 IU/kg injection SC, 0.4 IU/kg Gan & Lee insulin glargine injection SC,
16052664|NCT02506634|Drug|Esomeprazole MUPS, 20 mg|According to the guidelines, the PPI treatment duration would be 8 weeks(Esomeprazole MUPS, 20 mg bid) for patients with reflux esophagitis and 4 weeks (Esomeprazole MUPS, 20 mg bid) for patients with normal findings on endoscopy.
16052665|NCT02506621|Device|R test|
16052666|NCT02506621|Device|Nuubo|
16052667|NCT02506621|Device|TECHNOMED pocket ECG|
16052668|NCT02506621|Device|ZIO xt patch|
16052669|NCT02506621|Device|MoMe|
16052670|NCT02506608|Procedure|Operation of sensorized hand prosthesis|"Four TIME-4H electrodes will be implanted in the median and ulnar of the amputees. The electrodes will be connected with the STIMEP electrical multichannel stimulator. The stimulator will be connected with one of the sensorized prostheses. Afferent and efferent signals will be elaborated and integrated by the ODROID software.
~The amputees will be able to control the prostheses movement and receive a sensory feedback from the prosthesis sensors.
~The use of the prosthesis during different tasks will be considered the intervention."
16052671|NCT02506595|Behavioral|ERRT-M for Nightmares|Exposure, Relaxation, and Rescripting Therapy Military version (ERRT-M) - Five 60-90 minute sessions administered once weekly. ERRT-M includes psychoeducation, sleep habit modification, relaxation training, written exposure to and rescription of nightmare content and imagery rehearsal of rescripted dream content.
16052672|NCT02506582|Dietary Supplement|jerusalem artichoke and fermented soybeans powder mixture|40 g jerusalem artichoke and fermented soybean powder mixture
16052673|NCT02506582|Dietary Supplement|placebo|40 g powdered rice flour
16052674|NCT02506569|Device|Implantable Cardioverter Defibrillator therapy|Tachycardia Fast Heart Beat
16052675|NCT02506569|Other|Magnetic Resonance Imaging (MRI)|MRI scan of the head and lower body parts
16052676|NCT02506556|Drug|BYl719|"Treatment: BYL719 350mg orally daily Treatment will be given daily until progression, undue adverse events or withdrawal of consent.
~Dose reductions (two levels) are allowed. Each cycle is 28 days"
16052677|NCT02506543|Behavioral|COMPASS|COMPASS (Creating Opportunities through Mentoring, Parental involvement and Safe Spaces) is a program for 13-19 year old girls in three refugee camps in Ethiopia. The program is a structured intervention that is intended to engage adolescent girls, through life skills training and establishing or supporting community-supported safe spaces for girls where they can come and gather among themselves and participate in a structured life-skills curriculum.
16052678|NCT02506543|Behavioral|No intervention|Wait list control group will not receive an intervention. After the follow-up study, the wait-list control group will receive the regular COMPASS program
16052679|NCT02506530|Procedure|intensive decongestive treatment|intensive decongestive treatment
16052680|NCT02506530|Device|Cellu M6|Use of Cellu M6
16052681|NCT02506517|Drug|Afatinib|
16052682|NCT02506504|Device|Inspiratory help then sham ventilation|The Inspiratory Pressure Support is used to increase the intensity and the duration of training session. For the sham ventilation, the device deliver a non effective quantity of oxygen.
16052724|NCT02506192|Drug|Placebo|Placebo oral tablets (2x5mg) daily for 8 weeks
16052825|NCT02505334|Drug|liraglutide|Injected subcutaneously s.c. (under the skin) once daily.
16052683|NCT02506504|Device|Sham ventilation then Inspiratory help|The Inspiratory Pressure Support is used to increase the intensity and the duration of training session. For the sham ventilation, the device deliver a non effective quantity of oxygen.
16052684|NCT02506491|Other|Pilates exercise|2 sessions/week, 1 hour/session during 18 weeks. Intensity determined from 6 to 9 points, controlled by the Resistance exercise scale of perceived exertion (OMNI-RES).
16052685|NCT02506491|Other|Muscular exercise|2 sessions/week, 1 hour/session during 18 weeks. Intensity determined from 6 to 9 points, controlled by the Resistance exercise scale of perceived exertion (OMNI-RES).
16052686|NCT02506491|Other|Control Group|No exercise
16052687|NCT02506478|Other|Beverage procurement|All Emergency Department patients will be approached to ask their beverage preferences in a randomly permuted data collection form. If they would like juice, the flavor will be recorded and the juice (and/or water) will be procured by a research assistant if the patient would like that, though the actual procurement of the juice is not part of the study.
16052688|NCT02506465|Device|iTIND|Temporary Implantable Nitinol Device (iTIND)
16052689|NCT02506465|Procedure|Sham Arm|Foley catheter will be placed and immediately removed.
16052690|NCT02506452|Other|Biovance®|Application of Biovance® for up to 12 weeks or until wound closure, whichever is sooner. Non-active moist wound treatment, debridement as needed, off-loading
16052691|NCT02506452|Other|Standard of Care, Diabetic Foot Ulcers|Non-active moist wound treatment, debridement as needed, off-loading for up to 12 weeks or until wound closure, whichever is sooner
16052692|NCT02506439|Dietary Supplement|10 mcg Vitamin D3|Once daily, 10mcg (400IU) dose of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)
16052693|NCT02506439|Dietary Supplement|20 mcg Vitamin D3|Once daily, 20mcg (800IU) dose of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)
16052694|NCT02506439|Dietary Supplement|Placebo|Once daily, placebo capsule containing 0mcg (0IU) of vitamin D3 taken from baseline visit (approx 15 weeks gestation) until endpoint (delivery)
16052695|NCT02506426|Procedure|Endoscopic sinus surgery + Septoplasty|Opening of the paranasal sinuses along with correcting the nasal septum
16052696|NCT02506426|Procedure|Septoplasty alone|Straightening of the nasal septum without opening the paranasal sinuses
16052697|NCT02506413|Other|MamaToto Package|"The MamaToto Package (later called Mama na Mtoto for the Tanzanian context) was an MNCH intervention built upon prior successes in Uganda and adapted to meet the needs in Misungwi District in Tanzania. The intervention included low-cost programming that built upon the existing district health system structure and resources in order to strengthen the MNH capacity and training of the district, health facilities, and community health workers."
16052698|NCT02506387|Device|mitraclip|The decision to implant mitraclip is not part of this observational study but is made by the heart-team.
16052699|NCT02506348|Drug|Diclofenac|
16052700|NCT02506348|Drug|Nepafenac|
16052701|NCT02506335|Drug|Cholate testing|The patient receives simultaneously an oral dose of d4-cholate and an IV dose of 13C-cholate, which are stable isotopes; there is no radioactivity or radiation exposure.
16052702|NCT02506322|Behavioral|SEKT - Cognitive-Behavioral-Emotional|"This Bipolar Disorder specific psychotherapy has 4 modules:
~psychoeducation, life chart, relapse experiences, personalized explanation, early symptoms and recognition of a new episode, self observation
~Stress regulation, sleep-wake cycle, social rhythm, daily and weekly structure of life, life balance
~dysfunctional cognitions, cognitive techniques, meta-cognitive techniques, emotion regulation methods
~behavior changes, (social, problem solving) skill training, communication skills, crisis management"
16052703|NCT02506322|Behavioral|FEST - Clinical Supportive Educational|This active control psychotherapy has 2 modules: (a) psychoeducation about Bipolar Disorder, the etiology and development of this disorder, drug options, effects and side effects of medication, compliance, how to handle unwanted side effects (b) group discussion and exchange about disorder relevant and personal relevant topics related to Bipolar Disorder, therapist is passive, encouraging, listening, verbalizing feelings and emotion, strengthening subjects resources
16052704|NCT02506309|Device|TOT - inside-out trans-obturator tape/sling|Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)
16052705|NCT02506309|Device|SIS - Innovative fixation single incision sling|Patients were randomized by envelope technique at the time of surgery indication to either TOT or SIS anti-incontinence surgical procedure with mid-urethral slings (MUS)
16052706|NCT02506296|Drug|DPPIV inhibitor -|Mixed Meal Tolerance Test with or without a DPPIV inhibitor
16052707|NCT02506296|Device|Continuous glucose monitoring system.|participant's will self-monitor blood glucose over a 4-6 day period via a CGM monitor inserted just under the skin.
16052708|NCT02506283|Device|Zamar Therapy CT clinic|Zamar Therapy is a certified medical product (directive 93/42/EEC and ISO 134 85:2012) (www.zamarmedical.com)
16052709|NCT02506270|Device|Airseal Trocar|28 patients are treated with the AirSeal insufflation and trocar system
16052710|NCT02506270|Device|conventional trocar|28 patients are treated with a conventional insufflation and trocar system
16052711|NCT02506257|Drug|0.04% PHMB|0.04% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
16052712|NCT02506257|Drug|0.06% PHMB|0.06% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
16052713|NCT02506257|Drug|0.08% PHMB|0.08% PHMB eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
16052714|NCT02506257|Drug|PHMB Vehicle|PHMB vehicle eye drops, 1 drop 12 times daily for 7 days, followed by 1 drop 6 times daily for additional 7 days
16052715|NCT02506244|Device|iRhythm ZIO XT Patch|Single-lead ECG monitoring via a wearable patch
16052716|NCT02506244|Device|Wristband by Amiigo|Determines pulse rate using photoplethysmography.
16052717|NCT02506231|Drug|Folinic acid|
16052718|NCT02506231|Drug|Placebo|
16052719|NCT02506218|Dietary Supplement|10 + 20 g protein consumption|whey isolate
16052720|NCT02506218|Other|30 g protein breakfast|30 g mixed meal breakfast
16052721|NCT02506218|Other|10 g protein breakfast|10 g mixed meal breakfast
16052722|NCT02506205|Behavioral|Lee Silverman Voice Treatment (SVLT) LOUD|
16052757|NCT02505906|Radiation|Simultaneous Integrated Boost Technique|
16052725|NCT02506166|Device|Positive Airway Pressure Therapy|Positive Airway Pressure Therapy will be used in Group 3 for treatment of predominant obstructive sleep apnea
16052726|NCT02506153|Biological|Ipilimumab|Given IV
16052727|NCT02506153|Biological|Pembrolizumab|Given IV
16052728|NCT02506153|Other|Quality-of-Life Assessment|Ancillary studies
16052729|NCT02506153|Biological|Recombinant Interferon Alfa-2b|Given IV and SC
16052730|NCT02506140|Drug|Ticagrelor and Acetylsalicylic acid|This group will receive a 180 mg loading dose of ticagrelor on the day of randomization, followed by 90 mg twice/day ticagrelor from Day 2 to 3 months; combined with Aspirin given in a total dose of 100-300 mg on the first day, followed by 100 mg once/day from Day 2 to Day 21.
16052731|NCT02506140|Drug|Clopidogrel and Acetylsalicylic acid|This group will receive a 300 mg loading dose of clopidogrel on the day of randomization, followed by 75 mg once/day clopidogrel from Day 2 to 3 months; combined with Aspirin given in a total dose of 100-300 mg on the first day, followed by 100 mg once/day from Day 2 to Day 21.
16052732|NCT02506127|Device|Neuronetics XPLOR system|Transcranial magnetic stimulation system
16052733|NCT02506114|Biological|PROSTVAC V/F|PROSTVAC-V/F is a prostate-specific antigen(PSA)-based immunization strategy. It is intended to generate immune responses to prostate specific antigens and prostate cancer cells. It uses poxviral vectors to introduce modified PSA to the patient in an immunogenic manner to break self-tolerance, and thereby induce immune responses directed against prostate cancer cells.
16052734|NCT02506114|Drug|Ipilimumab|
16052735|NCT02506101|Device|narrow-band ultraviolet B phototherapy|There are two types of UVB: broad band and narrow band, with the major difference being that narrow band emits a smaller range of ultraviolet light, typically 311-312 nm. NB-UVB is a clinically indicated treatment for vitiligo lesions and treatments are usually administered in an outpatient setting 3 times a week.
16052736|NCT02506088|Behavioral|Your Voice Your View|Session 1 of the intervention involves background information, an introduction to social norms, and bystander intervention skills training. Session 2 of the intervention establishes conditions for consent, types of abusive behavior and identifying abuse. Session 3 of the intervention addresses risk reduction strategies for girls. Session 3 of the intervention addresses false accusations, masculinity, and additional practice on identifying conditions for consent for boys. Session 4 of the intervention includes active practice of bystander intervention skills.
16052737|NCT02506075|Device|Transcranical direct current stimulator|approved by Conformity European as safe treatment device for stroke patients
16052738|NCT02506075|Behavioral|Visual inattention training|
16052739|NCT02506062|Device|Manual blood pressure cuff inflation over brachial artery|A manual blood pressure cuff (sphygmomanometer) is used in the study as a tourniquet in order to perform a controlled, consistent level of ischemia (200mmHg/active arm or 60 mmHg/placebo arm).
16052740|NCT02506049|Device|S-LPC:Selective Laser Photocoagulation|Under anesthesia (epidural, general anesthesia with intubation, or intravenous sedation with infiltration of a local anesthetic), one treatment with the use of fetoscopy instrument sets for Selective Laser Photocoagulation (S-PLC) to seal the connecting blood vessels, help to normalize blood flow between twins.
16052741|NCT02506036|Other|Brain HQ|Brain HQ is a web application that will be used to provide patients with a training intervention that addresses deficits in social-emotional functions. These include areas such as identifying facial expression, understanding tone of voice, and predicting how people may react in certain situations. The training will take about 30 hours over the course of 4-6 weeks and is done at home.
16052742|NCT02506023|Drug|Desmopressin|Desmopressin or DDAVP will be administered intravenously (IV) via a nontraumatic peripheral IV line at a dose of 0.3 mcg/kg over 30 minutes.
16052743|NCT02505997|Drug|Midazolam|Single 5 mg oral dose of midazolam syrup given in the AM on Day 1 and Day 8.
16052744|NCT02505997|Drug|Delafloxacin|Oral 450 mg delafloxacin tablets given twice daily (Q12h) on Days 3 to 8
16052745|NCT02505984|Drug|Oxytocin|Study participants will be randomized to a placebo or drug group.
16052746|NCT02505984|Drug|Placebo|Study participants will be randomized to a placebo or drug group.
16052747|NCT02505971|Drug|Nadolol|"Patients will be administered twice-daily doses of medication as follows: since Day 0- 0.5 mg/kg/day ; since Day 7-1.0 mg/kg/day and since Day 14- 1.5 mg/kg/day. In all subsequent visits the dosage will be adjusted based on the current weight rather than the baseline weight to maintain 1.5 mg/kg/day. Or the dose may be escalated (by 0.5 mg/kg/day at any following study visit) up to 3 mg/kg/day based on the clinical response to maintain the dose that led to at least 75% reduction in the hemangioma size until Week 24, when unblinding happen. At Week 24 paticipants can start weaning by 10% per week or continue with the last dose, depending on the investigator's decision.
~S/he will be monitored until Week 52."
16052748|NCT02505971|Drug|Propranolol|"Patients will be administered twice-daily doses of medication as follows: since Day 0- 0.5 mg/kg/day ; since Day 7-1.0 mg/kg/day and since Day 14- 1.5 mg/kg/day.
~In all subsequent visits the dosage will be adjusted based on the current weight rather than the baseline weight to maintain 1.5 mg/kg/day. Or the dose may be increased by investigator, based on clinical response by 0.5 mg/kg/day at any study visit (up to 3 mg/kg/day divided twice a day) to maintain the dose that lead to at least 75% reduction in the hemangioma size until Week 24, when unblinding happen. At Week 24 paticipants can start weaning by 10% per week or continue with the last dose, depending on the investigator's decision.
~S/he will be monitored until Week 52."
16052749|NCT02505958|Other|high caloric intake|Volunteers will be started on a diet program for 4 ½ days, consisting of 3 meals and 3 snacks over a 24 hour period and containing ~ 6000 Kcal/24 h.
16052750|NCT02505958|Other|reduced caloric intake|On days 5 and 6, volunteers will received 3 meals (~333 calories each) totaling ~ 1,000 calories/24 hours.
16052751|NCT02505945|Drug|Omeprazole|
16052752|NCT02505945|Device|LINX Reflux Management System|
16052753|NCT02505932|Procedure|Arthroscopic Latarjet procedure|arthroscopic approach (set Depuy-Mitek, Raynham, MA)
16052754|NCT02505932|Procedure|Mini-open Latarjet procedure|mini-open approach (set Arthrex, Naples, FL)
16052755|NCT02505919|Device|AQUABEAM System|To utilizes proprietary heat-free high-pressure waterjet technology to resect and remove prostate tissue using the AQUABEAM system, which is a personalized image-guided tissue removal system.
16052756|NCT02505919|Procedure|Transurethral Resection of the Prostate (TURP)|Transurethral resection of the prostate (TURP) is a type of prostate surgery done to relieve moderate to severe urinary symptoms caused by an enlarged prostate, a condition known as benign prostatic hyperplasia (BPH)
16052758|NCT02505893|Biological|Human pancreatic islet|One thousand and five hundred (1,500) equivalent islet for Kg of body weight, isolated from a single brain-dead donor, will be infused into the patient's liver.
16052759|NCT02505893|Drug|ATG|ATG will be administered IV (central vein) at a total dose of 6 mg/kg up to day 6 post-transplant
16052760|NCT02505893|Drug|Pegylated G-CSF|Pegylated G-CSF (6 mg/dose) will be administered SC every 2 weeks for 6 doses (12 weeks) beginning after the last ATG infusion
16052761|NCT02505893|Drug|Rapamycin|Rapamycin will be administered orally at a starting dose of 0.2 mg/kg once a day, then targeted to blood trough level of 8-10 ng/mL and suspended one month after transplant.
16052762|NCT02505880|Other|Local anesthetic + Hypnosis|Modified state of consciousness allowing to be at the same time here and somewhere else. The individual is going to dive into his imagination to extract of an uncomfortable situation. And local anesthetic (solution of Xylocaine with adrenaline 1 % dabbed in 20 % of bicarbonate of sodium 4,2 %, maximal dose of 0,5ml / kg)
16052763|NCT02505880|Drug|General anesthesia|Sufentanil intravenous (0.1 in 0.2 µg / kg) and propofol (5 in 10 mg / kg on 3 mn) administration
16052764|NCT02505867|Device|Adaptive Servo Ventilation|Participants are provided with an Adaptive Servo Ventilation (ASV) device for targeted treatment of SDB during inpatient hospitalization or shortly after discharge.
16052765|NCT02505854|Dietary Supplement|Probiotic|Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache of maltodextrin
16052766|NCT02505854|Dietary Supplement|Symbiotic|Hypocaloric diet associated with capsule containing 1billion UFC Bifidobacterium lactis and sache of fructooligosaccharide
16052767|NCT02505854|Dietary Supplement|Placebo|Hypocaloric diet associated with capsule containing 50g of gelatin and sache of maltodextrin
16052768|NCT02505841|Other|TAP block with Ropivacaine|Ultrasound-guided transversus abdominis plane block wih Ropivacaine injection 0.2% at 0.3 ml/kg
16052769|NCT02505841|Drug|Curare|Atracurium injection at 0.5 mg/kg at least 3 minutes before the surgical incision
16052770|NCT02505828|Procedure|Articular punction, salivary samples, blood sample|
16052771|NCT02505815|Procedure|Surgery|
16052772|NCT02505815|Procedure|Cortisol Level Measurement|
16052773|NCT02505815|Procedure|Neurocognitive Testing|
16052774|NCT02505802|Drug|BoNT-A injection|In BoNT-A treatment group patients received 200 units BoNT-A injection in the triceps surae (150iu) and tibial muscle posterior (50iu).
16052775|NCT02505789|Other|Determining the source of EBV in severe EBV infections|Blood units administered to patients with severe EBV infection will be traced back to the donors who in turn (with consent) will be serologically assessed for EBV, and all seropositive donors will have their EBV strain genotyped for comparison to the patient's strain.
16052776|NCT02505776|Drug|Bimatoprost cutaneous solution 0.03%|Bimatoprost cutaneous solution 0.03% (GLASH VISTA™) prescribed as per standard of care in clinical practice.
16052777|NCT02505763|Procedure|Strategy with thoracic ultrasound|This strategy involves the systematic use of thoracic ultrasound for the treatment of pleural effusion, treatment and follow up care.
16052781|NCT02505737|Behavioral|TH-CBT|Telephone-Based Cognitive Behavioral Therapy (TH-CBT). A 10-session treatment protocol that incorporates behavioral activation, thought monitoring and restructuring, relaxation training, worry control, sleep hygiene, and caregiver psychoeducation and support
16052782|NCT02505737|Other|Enhanced Usual Care|Community-based treatment as usual and supplemental reading material
16052783|NCT02505724|Behavioral|conventional training|After completing the initial assessment, faculty randomized to the conventional training group received a link to a web-based instructional video. In addition, they were given a laparoscopic box trainer, laparoscopic instruments and sutures that they could use to practice with at their leisure.
16052784|NCT02505724|Behavioral|peer-coaching|Faculty randomized to the peer-coaching group received ½ hour of peer-coaching after completing the initial assessment on the simulator. Each faculty member sutured on the box trainer while being observed by his or her peer-coach. All study participants had the same peer-coach.After the coaching session, study participants received a link to the web-based video as well as the box trainer and supplies to independently practice laparoscopic suturing. Similar to individuals in the control group, no specific guidance regarding the amount of independent practice was given.
16052785|NCT02505711|Behavioral|Homestead Food Production program|Training and support for vegetable gardening and poultry rearing, and education on young child nutrition, hygiene and health topics, in women's groups, as designed by the international non-governmental organization (NGO) Helen Keller International (HKI).
16052786|NCT02505672|Radiation|Chemoradiotherapy for nasopharyngeal carcinoma|Note that this is standard care for NPC and patients are not assigned to different intervention groups. All patients in the study will receive the same treatment (chemoradiotherapy) and will be observed for changes in vestibular function.
16052787|NCT02505659|Behavioral|Preoperative re-education|Preoperative re-education (behavior): 8 re-education sessions of 30 to 40 minutes, 2 times a week, for 4 weeks
16052788|NCT02505646|Other|Observational study. No special intervention will be made|Data will be recorded in a context of fluid load in a context of circulatory failure. Stroke volume will be monitored, before, after an abdominal compression and after a fluid load.
16052789|NCT02505633|Device|Stimuplex insulated needle|"2P2I group: nerve stimulating needle is advanced twice and LA is injected 15 mL at a time.
~1P1I group: nerve stimulating needle is advanced once and LA is injected 30 mL."
16052790|NCT02505633|Drug|lidocaine mixed with epinephrine|2P2I group and 1P1I group use the same LA (1.5% lidocaine mixed with 1:200,000 epinephrine). But 2P2I group is injected LA at equally divided doses (15 mL at a time). 1P1I group is injected LA 30 mL at once.
16052791|NCT02505620|Procedure|Treatment of OSAS with CPAP mask|Interventional treatment addresses the treatment with a CPAP (continuous positive airway pressure) mask in oder to open patients upper airway obstructive permanently while sleep.
16052792|NCT02505620|Procedure|Surgical Treatment with multilevel operation|Surgical treatment addresses a surgical multilevel anti-obstructive operation in order to eliminate upper airway obstruction permanently.
16052793|NCT02505607|Other|Overactive Bladder Care Plan counseling|"Use of a printed Overactive Bladder Plan of Care information sheet."
16052794|NCT02505581|Drug|Extra dosage - cefuroxime (750mg) I.V|In both groups a second intravenous dose of cefuroxime (750mg) will be administered if the intraoperative time elongates more than three hours or there is an intraoperative bleeding over 1000cc
16052795|NCT02505581|Procedure|Colorectal Surgery|Both groups undergo colorectal surgery. This section does not include rectal surgery ( see Inclusion/exclusion criteria)
16052796|NCT02505581|Drug|Ciprofloxacin 750 mg oral|An oral antibiotic pattern of ciprofloxacin (750 mg / 12h, 2 doses) the day before surgery.
16052797|NCT02505581|Drug|Metronidazole 250 mg oral|An oral antibiotic pattern of metronidazole (250 / 8h, 3 doses) the day before surgery.
16052798|NCT02505581|Drug|Cefuroxime 1.5 g Intravenous|An intravenous antibiotic pattern of cefuroxime 1.5 g during anesthetic induction.
16052799|NCT02505581|Drug|Metronidazole 1 g Intravenous|An intravenous antibiotic pattern of metronidazole 1 g during anesthetic induction.
16052800|NCT02505568|Drug|Infliximab|Participants will receive infliximab 5 milligram per kilogram (mg/kg) infusion at Week 0, Week 2, and Week 6 for the induction phase. Participants who complete the induction phase will continuously receive 5 mg/kg infliximab infusion every 8 weeks up to week 32 in the maintenance phase.
16052801|NCT02505555|Device|four dimensional hysterosalpingo-contrast sonography|compare accuracy and tolerability of 4D-HyCoSy with that of laparoscopy and chromotubation
16052802|NCT02505542|Biological|Certolizumab Pegol|"Active substance: Certolizumab Pegol
~Pharmaceutical form: Prefilled syringe
~Concentration: 200 mg / ml
~Route of Administration: Subcutaneous injection"
16052803|NCT02505542|Other|Placebo|"Active substance: Placebo
~Pharmaceutical form: Prefilled syringe
~Concentration: 0.9 % Saline
~Route of Administration: Subcutaneous injection"
16052804|NCT02505529|Other|Resistance Exercise Training|Behavioral interventions of resistance exercise
16052805|NCT02505529|Other|Mental Imagery|Behavioral intervention of mental imagery
16052806|NCT02505516|Other|metformin|
16052807|NCT02505503|Device|Unloading shoes|The unloading shoe will be a trainer-type shoe with a rocker sole incorporated. The sole is designed to influence the line of action of the ground reaction force to pass close to the anatomical joint centres and so reduce the moments needed to be generated for ambulation by the muscles acting across those joints in the lower limb. Additionally it is designed to place the ankle into a relatively plantarflexed position where the ankle plantarflexors use less energy than for instance when placed in dorsiflexion.
16052808|NCT02505503|Device|Unadapted control shoe|During the control condition assessments, participants wear a pair of appropriately-sized shoes, which are similar in appearance to the unloading shoes, but do not contain the altered sole.
16052809|NCT02505490|Other|Television|The purpose is to determine whether television impacts liking of food.
16052810|NCT02505490|Other|No Television|The purpose is to determine whether the lack of television impacts liking of food.
16052811|NCT02505477|Drug|N-acetylcysteine|N-acetylcysteine is a safe, widely available supplement currently FDA-approved for treatment of acetaminophen antidote and as a mucolytic. It has effects on glutamate in the brain via the NMDA receptor as well as the glutathione antioxidant system (it is a precursor to glutathione).
16052812|NCT02505477|Other|Treatment as Usual|Treatment for schizophrenia which may include medications, therapy, or other types of treatment as determined by the subject's VA or community psychiatrist or mental health treatment team
16052813|NCT02505451|Drug|dobutamine|In each participant, dobutamine will be administered via intravenous infusion in doses of 10, 20, 30 and 40 lg/kg/min during 3-min stages and 2D strain echocardiography will be performed at each stage.
16052814|NCT02505438|Behavioral|Exercise|
16052815|NCT02505425|Behavioral|Behavioral Support|"ENABLE CHF-PC includes:
~In-person comprehensive Palliative Care Team (PCT) Consultation- as soon as feasible after enrollment.
~Palliative Care Nurse Coach (PNC) embedded within HF teams, instituting a phone-based 6-session patient and a 4-session caregiver curriculum followed by monthly phone-based supportive care for 48 weeks or patient death.
~The PNC uses the manualized curriculum: Charting Your Course (CYC): An Intervention for Patients with Heart Failure and their Families.
~Usual Care: Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines."
16052816|NCT02505425|Behavioral|Usual HF Care|Usual heart failure care includes any available supportive care resources and heart failure patient medical management based on national HF guidelines.
16052817|NCT02505399|Drug|ticagrelor|"Ticagrelor will be administered orally, according to the following scheme:
~180 mg the evening preceding (and at least 6 hours before) rotational atherectomy (Day -1),
~90 mg the following morning (D Day before rotational atherectomy and angioplasty),
~90 mg the following evening (D Day after rotational atherectomy and angioplasty),
~90 mg twice daily the day after the procedure of rotational atherectomy and angioplasty (Day +1)."
16052818|NCT02505399|Drug|clopidogrel|"Clopidogrel will be administered orally, according to the following scheme:
~300 mg the evening preceding (and at least 6 hours before) rotational atherectomy (Day -1),
~75 mg the following morning (D Day before rotational atherectomy and angioplasty),
~0 mg the following evening (D Day after rotational atherectomy and angioplasty),
~75 mg once daily the day after the procedure of rotational atherectomy and angioplasty (Day +1)."
16052819|NCT02505386|Drug|Ertapenem|
16052820|NCT02505373|Behavioral|Attempted Suicide Short Intervention Program (ASSIP)|"The brief therapy ASSIP consists of three to four sessions, which are ideally administered within a period of 2 to 4 weeks. Therapy sessions are scheduled for 60 to 90 minutes.
~Session 1: A narrative interview is conducted, in which the patient is asked to tell his or her personal story which led to the suicidal crisis. The narrative is video-recorded.
~Session 2: Using video-playback of the recorded narrative, patient and therapist explore further details of the suicidal process.
~Session 3: A case conceptualization focusing on the patient's vulnerability and the trigger of the suicidal crisis is formulated in writing. A list of safety strategies for the prevention of future suicidal behaviour is developed jointly with the patient.
~Regular letters are sent to patients over a period of 2 years."
16052821|NCT02505373|Behavioral|Control Group (CG)|Participants assigned to the control group underwent a single clinical interview that included a structured assessment of suicide using the SSF (Jobes, 2006).
16052822|NCT02505360|Other|Measurements of concentration of hyaluronic acid as well as in type 1 collagen and 3|
16052823|NCT02505347|Other|No splint|Can move arm as tolerated with no restrictions on mobility
16052824|NCT02505347|Device|Splint|Wear splint for 6 weeks, only to remove for rehab and personal care
16052826|NCT02505321|Other|Oral Triglyceride Tolerance Test (OTTT)|Participants consume a fatty drink. An intravenous catheter is inserted into the antecubital veins in one arm for intermittent sampling over the following 4 hours. The OTTT permits simple evaluation of postchallenge triglyceride levels and is acceptable to participants.
16052827|NCT02505321|Procedure|Abdominal fat biopsy (optional)|A sample of abdominal fat will be obtained by firstly injecting some local anaesthetic into an accessible area of the abdomen. Using a scalpel, a small incision (approx 2-3 cm) will be made to a depth of approx 15mm and two small pea-sized samples of fat will be removed. The wound will be closed with simple sutures or steristrips.
16052828|NCT02505308|Other|Glucose-Potentiated Arginine-Induced Insulin Secretion|Intravenous catheters are inserted into antecubital veins in both arms. One arm is used for infusion of glucose/amino acid (Arginine). The other arm is used for intermittent sampling.
16052829|NCT02505295|Dietary Supplement|Selenium|4 vials selenase stat and 2 vials daily for 5 days
16052830|NCT02505295|Drug|normal saline|Normal saline infusion like intervention group
16052831|NCT02505282|Other|Vitamin K status|Vitamin K status indicated by desphospho-uncarboxylated matrix Gla protein level
16052832|NCT02505269|Drug|Brentuximab Vedotin|
16052833|NCT02505269|Drug|Adriamycin|
16052834|NCT02505269|Drug|Dacarbazine|
16052835|NCT02505256|Other|No intervention|
16052836|NCT02505230|Behavioral|Eating|Participants will have 20 minutes to eat as much or as little of a meal (consisting of pasta alone or pasta with zucchini and squash presented in 3 different ways)
16052837|NCT02505204|Other|Clonidine|The anesthetic mixture will contain: lidocaine 2% 7 mL, lidocaine 2% 6 mL with epinephrine 5µg.mL-1, bupivacaine 0.5% 5 mL, and clonidine 2 mL.
16052838|NCT02505204|Other|Placebo|the same anesthetic mixture will be administrated however the clonidine will be substituted with 2 mL saline.
16052839|NCT02505191|Drug|St. John's wort prolonged-release tablet 500 mg|
16052840|NCT02505191|Drug|St. John's wort film coated tablets 250 mg|
16052841|NCT02505178|Other|Problem Solving Therapy|PST is a minimally invasive treatment. The five sessions of CM implemented PST will involve psychotherapy also known as talk therapy between the CM's and study participants in a group setting. Psychogeriatric interdisciplinary staff (CM's) i.e. psychiatric nurses, social workers who have been previously trained in PST will function in the roles of facilitator, cofacilitator and scribe. The roles can be shared amongst the professionals to build capacity in each role or maintained over time if so desired. Sessions will be approximately one-and-a-half to two hours in length and conducted at the Cherry Hill Mall library in London.
16052842|NCT02505165|Behavioral|IMPACT|• The intervention is 6 sessions lasting approximately 45 minutes reviewing ways to help prevent and respond to illness uncertainty. Sessions occur weekly at already scheduled clinic appointments. Interventions will be delivered by a trained interventionist.
16052843|NCT02505165|Other|ESO|This control is 6 sessions lasting approximately 45 minutes providing education on cancer etiology, medical treatments, side effects, potential short- and long-term effects of treatment and resources that are often helpful to parents of children with cancer. Sessions occur weekly at already scheduled clinic appointments. Interventions will be delivered by a trained interventionist.
16052844|NCT02505152|Procedure|Percutaneous transhepatic intrahepatic portosystemic shunt|Under fluoroscopic guidance, portal vein(PV) was punctured with a 22-gauge Chiba needle. A 0.018-inch guidewire was advanced through the needle into PV lumen. The needle was exchanged and a 7-French sheath inserted over the wire. Then retrohepatic inferior vena cava(RIVC) or hepatic vein(HV) was punctured with a 20-gauge, 30-cm Chiba needle through sheath. Another 0.018-inch guidewire was advanced through the needle into right internal jugular vein and then snared out of body. A 0.035-inch, 260-cm stiff shaft wire was then introduced through the transjugular sheath and manipulated into main portal vein(MPV) and then into superior mesenteric vein(SMV). Afterward the PTIPS procedure was completed in the standard transjugular fashion.
16052845|NCT02505139|Other|the number of circulating tumor cells|
16052846|NCT02505126|Device|Active tDCS|One daily session (13:20:13) : active current flows continuously twice for 13 minutes with a rest interval (no stimulation) of 20 min 5 sessions (once a week for 5 consecutive days)
16052847|NCT02505126|Device|Placebo tDCS|One daily session (13:20:13) : inactive current flows continuously twice for 13 with a rest interval (no stimulation) of 20 min 5 sessions (once a week for 5 consecutive days)
16052848|NCT02505113|Drug|Montelukast|Montelukast (10mg, q.d., p.o.)
16052849|NCT02505100|Other|Touching relaxant|
16052850|NCT02505100|Other|Hypnoses|
16052851|NCT02505087|Drug|N-Acetylcysteine followed by Placebo|"Arm receiving N-Acetylcysteine (NAC) for 6 months and then placebo for 6 months.
~Treatment periods are separated by a 2 month washout."
16052852|NCT02505087|Drug|Placebo followed by N-Acetylcysteine|Arm receiving placebo for 6 months then N-acetylcysteine (NAC) for 6 months. Treatment periods are separated by a 2 month washout.
16052853|NCT02505074|Procedure|Valve replacement with the Melody valve|This study will only review patients who have had the Melody valve surgically inserted into the Mitral and/or Tricuspid positions. We will not be reviewing any other intervention type.
16052854|NCT02505061|Behavioral|Hospital-based Program|"The research team will discuss with the clinical therapists who will provide training program in a hospital for 120 minutes/per session, 2 sessions/per week for a total of 9-week intervention. In addition, the research team will videotape the childs natural play and driving performance at the hospital for 20 minutes/per session, 1 session/per week during the 9-week intervention phase. The treatment program of the two sessions will be preplanned and adjusted by the occupational therapist through clinical observation of participant's performance in the previous session. Training will still concentrate on building the concept of casual-effect on the switch and car motion, goal-oriented driving (e.g., driving 200 meters and reach for a toy or contact with a person), and upper limb use in functional tasks with driving in a hospital,discussed by the family, the treating therapist and the research team."
16052855|NCT02505061|Behavioral|Regular Therapy Program|"The regular therapy group will continue the regular therapy, including physical, occupational and speech therapy. The general propose of the training is to improve the developmental scales, mobility, socialization and upper limb use in functional tasks. The research team will videotape the childs natural play and driving performance at the hospital for 20 minutes/per session, 1 session/per week during the 9-week intervention phase"
16052856|NCT02505048|Drug|rucaparib|600 mg bid per os , 28 day cycle, number of cycles: until progression or unacceptable toxicity develops.
16052858|NCT02505022|Drug|Pharmacotherapy|Participants may receive pharmacotherapy in the course of treatment-as-usual. This observational study does not influence the type of treatment administered.
16052859|NCT02505022|Behavioral|Behavioral treatment|Participants may receive behavioral treatment in the course of treatment-as-usual. This observational study does not influence the type of treatment administered.
16052860|NCT02505009|Drug|Engerix-B|The case group will receive 5 Engerix-B injections during the last 6 months of a 3-year NA therapy.
16052861|NCT02505009|Drug|Tenofovir|Both case and control will receive 300 mg Tenofovir for at least 3 years
16052862|NCT02505009|Drug|Entecavir|Both case and control will receive 0.5 mg entecavir therapy for at least 3 years
16052863|NCT02504996|Drug|Paracetamol|1 g paracetamol via intravenous route in 100 ml normal saline
16052864|NCT02504996|Drug|morphine|0.1 mg/kg morphine via intravenous route in 100 ml normal saline
16052865|NCT02504996|Drug|Placebo|Intravenous 100 ml normal saline
16052866|NCT02504983|Drug|sorafenib|sorafenib is an oral, multikinase inhibitor approved for the treatment of advanced hepatocellular carcinoma
16052867|NCT02504983|Procedure|TACE|Transcatheter arterial chemoembolization was performed by the injection of small embolic particles coated with chemotherapeutic agents selectively into an artery directly supplying a tumor.
16052868|NCT02504957|Procedure|Photodynamic therapy using polyhematoporphyrin|
16052869|NCT02504944|Drug|Propranolol 0.2% eye drops|Enrolled preterm newborns will receive propranolol as ophthalmic solution (0.2%): 3 microdrops of 6 microliters (μL) propranolol solution (= 6 μg propranolol/microdrop) will be topically applied with a calibrated pipette, in each eye, four times daily (every 6 hours). Propranolol treatment will be always associated to the conventional approach adopted by the Early Treatment for Retinopathy of Prematurity Study (ETROP) Cooperative Group.
16052870|NCT02504931|Drug|Sertraline|A Randomized Controlled Trial Design will randomize subjects to one of two arms. Sertraline is the active medication treatment arm.
16052871|NCT02504931|Drug|Placebo|A Randomized Controlled Trial Design will randomize subjects to one of two arms. Placebo is the control medication treatment arm.
16052872|NCT02504905|Device|TMS|single TMS pulses at intensities in random order from 0 to 100% (increasing at 5% intervals) of stimulator output at a frequency of 0.1 Hz. Three pulses will be delivered at each intensity. MEPs will be recorded and their amplitudes will be plotted against the corresponding stimulation intensity. This curve will provide three significant parameters: (a) S50 intensity (intensity for which we get a MEP 50 % of its maximal size); (b) estimated resting motor threshold (RMT): the abscissa where the tangent to the slope crosses the x axis; and (c) the maximum MEP ( plateau value).
16052873|NCT02504892|Drug|Everolimus|Everolimus is a commercial agent and is supplied by Novartis.
16052874|NCT02504866|Other|Exercise|Exercise training of different intensity
16052875|NCT02504827|Drug|Ceftazidime/avibactam|Ceftazidime/avibactam 2.5gm iv q8h for 3 doses
16052876|NCT02504814|Device|Nasal Highflow (NHF)|changes in breathing physiology in NHF
16052877|NCT02504801|Drug|Budesonide|To test the hypothesis that nebulizer Pulmicort Respules could reduce post operation pulmonary complication incidence in primary lung cancer patients with COPD. Compare post-operation pulmonary complication incidence in two arms among primary lung cancer patients with COPD required single lobectomy from 3 days before operation to 7 days after operation.
16052878|NCT02504788|Radiation|hippocampal-sparing WBRT|
16052879|NCT02504775|Drug|Mejoral® 500 Tablets|500 mg tablet of paracetamol
16052880|NCT02504775|Drug|Tylenol® Caplets|500 mg tablet of paracetamol
16052881|NCT02504762|Procedure|Treatment|Hybrid Coronary Intervention = MICS CABG + Percutaneous Coronary Intervention. This study is a surgical intervention, which does not involve a drug or device intervention.
16052882|NCT02504762|Procedure|Control|Conventional CABG. This study is a surgical intervention, which does not involve a drug or device intervention.
16052883|NCT02504749|Procedure|general anasthesia,spinal anasthesia|"Randomization done by computer generated random number in sealed opaque envolopes.Each patient was given a study information sheet and a consent was signed. Sample size was calculated to prevent type II error. Based on these data, we would need to study 225 cases in each arm to be able to reject the null hypothesis that the rates for the experimental and control groups are equal with a probability of 80%. The type I error probability associated with this test for the null hypothesis is 0.05. We used an uncorrected chi-squared statistic to evaluate this null hypothesis. Additionally, to compensate for discontinuations, we recruited 225 women in each arm.
~450-pregnant women with an indication for caesarean section were randomly allocated ."
16052884|NCT02504723|Drug|carvedilol|Oral carvedilol is started after randomization at an initial dose of 6.25 mg daily. Doses are increased every 3 days during the admission or every 7 days in the out-patient clinics until the maximum tolerated dose was achieved or up to 25 mg daily, aiming at reducing resting pulse rate by 25 percent but not below 55 beats per minute with systolic blood pressure >90 mm Hg.
16052885|NCT02504723|Drug|cyanoacrylate|The patients undergo repeated endoscopic cyanoacrylate injection every 3-4 weeks until obturation of gastric varices.
16052886|NCT02504710|Device|Kinematic Real Time Feedback|
16052887|NCT02504710|Other|Traditional systems of manual therapy teaching|
16052888|NCT02504697|Other|Biosamples from airway and blood|Identify biomarkers in biosamples from airway and blood for the preclinical detection of lung cancer.
16052889|NCT02504684|Device|Endovenous 1920-nm diode laser|Patients with saphenous veins treated with a new 1920-nm diode endolaser.
16052890|NCT02504684|Device|Endovenous 1470-nm diode laser|Patients with saphenous veins treated with the standard 1470-nm diode endolaser.
16052891|NCT02504671|Drug|GSK3196165|GSK3196165 is supplied as liquid and will be administered as SC injection.
16052892|NCT02504671|Drug|MTX|MTX will be supplied as capsule, tablet or liquid and will be administered orally or as SC injection.
16052893|NCT02504671|Drug|Folic acid|Folic acid will be supplied as capsule, tablet or liquid and will be administered orally.
16052894|NCT02504671|Drug|Placebo|Placebo is supplied as liquid as sterile 0.9% weight by volume (w/v) sodium chloride solution and will be administered as SC injection
16052938|NCT02504411|Device|Standard Colonoscopy|No endocuff device will be used on the study participants undergoing standard colonoscopy.
16052939|NCT02504398|Other|Fast injection speed by immunizer|
16052940|NCT02504398|Other|Slow injection speed by immunizer|
16052895|NCT02504658|Behavioral|Lifestyle text messages|"Throughout the course of the four-week study, the experimental participants will receive one text message each morning related to general nutrition and exercise goals, and an additional goal status update message on Monday, Wednesday, and Friday evenings. The goal status update message will ask the participants about the status of attaining their nutrition or physical activity goals. Participants may log their progress toward attaining their goals by using the mobile health dashboard feature on BodiMojo.com from a computer or a web-enabled smartphone to indicate their goal status (still working on it or completed it). Participants will be encouraged, via the text messages, to look at information on the BodiMojo program found on the Bodimojo.com website."
16052896|NCT02504658|Behavioral|Attention Control Group|"Once participants randomized to the control group have completed the baseline assessment, they will be asked to write down two health goals with the RA. The same goals will be suggested for this group as for the Intervention group (see Appendix). They will take home a copy of the goals they have set. The participants will be also given a 16-page pamphlet from NIDDK A Guide for Teenagers: Take Charge of Your Health! to take home to read over."
16052897|NCT02504645|Drug|IPP-201101|
16052898|NCT02504645|Drug|Placebo|
16052899|NCT02504645|Other|Standard of Care|
16052900|NCT02504632|Other|test|"Peripheral venous citrated blood will be collected just before and 10-15 min after the implantation of the valve. Samples will be obtained after starting the infusion of contrast media. In peripheral venous blood before 24 h and after the procedure and at hospital discharge, 4-6 days when the usual transient thrombocytopenia after TAVI has recovered.
~The results will be used to analyse the kinetics of haematological changes in peripheral blood following aortic valve replacement.
~Platelet activation will be monitored by flow cytometry to assess the expression of specific membrane markers and the phosphorylation of signalling proteins, as well as the formation of platelet/monocyte aggregates."
16052901|NCT02504632|Other|control group|In this group, only one sample (2 tubes filled with 4.5 ml, i.e. 9ml) will be obtained in venous peripheral blood to establish reference values in age-matched, aspirin-treated, atherosclerotic population.
16052902|NCT02504619|Biological|CordIn|CordIn™ is a cryopreserved stem/progenitor cell-based product of purified CD133+ cells composed of ex vivo expanded allogeneic UCB cells.
16052903|NCT02504606|Drug|Besylsartan|Amlodipin besylate 6.944mg+Losartan K 100mg
16052904|NCT02504606|Drug|Amosartan|Amlodipin besylate 7.841mg+Losartan K 100mg
16052905|NCT02504593|Device|mHealth platform employing Fionet Deki Readers to ensure quality of community-based malaria diagnosis|The investigators propose to implement a new mobile interface that automatically reads and troubleshoots malaria rapid diagnostic test (RDT) cassettes. This device, called a Deki reader (DR), will allow the investigators to establish an extensive quality assurance program of malaria diagnosis performed by trained community health volunteers (CHVs). To ensure high-quality diagnosis by CHVs, the study team will deploy 10 Fionet DRs and rotate them amongst 200 CHVs who have been trained to do RDTs. In the first phase, each CHV will use the device for 10 successive clients presenting themselves for malaria diagnosis to the CHV, and then the device will be rotated to another CHV.
16052906|NCT02504580|Drug|HTX-011|
16052907|NCT02504580|Drug|Placebo|
16052908|NCT02504580|Drug|HTX-002|
16052909|NCT02504580|Drug|Bupivacaine Hydrochloride Injection|
16052910|NCT02504580|Drug|HTX-011A|
16052911|NCT02504580|Drug|HTX-011B|
16052912|NCT02504580|Drug|HTX-009|
16052913|NCT02504580|Drug|Marcaine|
16052914|NCT02504567|Device|Laser ablation|Pulmonary vein isolation using the laser ablation catheter
16052915|NCT02504567|Device|RF ablation|Pulmonary vein isolation using the RF ablation catheter
16052916|NCT02504554|Drug|oral Vancomycin|an antibiotic
16052917|NCT02504554|Drug|MoviPrep|a bowel cleanse
16052918|NCT02504554|Drug|Prilosec|a stomach acid suppressan
16052919|NCT02504554|Biological|human fecal material; processed, frozen administered orally|human fecal material; processed, frozen, administered orally
16052920|NCT02504554|Biological|human fecal material; processed, frozen; administered orally and rectally|human fecal material; processed, frozen; administered orally and rectally
16052921|NCT02504541|Combination Product|Testosterone enanthate auto-injector|Dose Adjustment 50 mg or 75 mg or 100 mg based upon Testosterone levels
16052922|NCT02504528|Other|house dust mites|house dust mites(two-fold increasing concentration of house dust mite (HDM) extract, dilutions prepared starting from 1:8, 1:16, 1:32, 1:64, 1:128, 1: 256, 1:512, 1:1024,……)
16052923|NCT02504515|Other|World Health Organization Quality of Life Bref Questionnaire|"The World Health Organization Bref (WHOQOL-BREF) questionnaire will be applied in three different moments: Baseline, after 6 months, and after 12 months.
~The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials."
16052924|NCT02504502|Other|enhanced genomic report|a patient-centered version of a genomic results report delivered to patient through the electronic record portal
16052925|NCT02504489|Drug|Docetaxel + Plinabulin (DP)|Docetaxel 75 mg/m2 IV + Plinabulin 30 mg/m2
16052926|NCT02504489|Drug|Docetaxel (D)|Docetaxel 75 mg/m2 IV
16052927|NCT02504476|Drug|AMG 581|Active drug
16052928|NCT02504476|Drug|Placebo|Placebo
16052929|NCT02504476|Drug|Midazolam|Interaction
16052930|NCT02504463|Drug|Samidorphan IV|Single IV administration
16052931|NCT02504463|Drug|[14c]-Samidorphan sublingual|Single sublingual administration containing radiolabel
16052932|NCT02504463|Drug|[14c]-Samidorphan oral|Single oral administration containing radiolabel
16052933|NCT02504450|Drug|Adasuve|Inhaled medication to treat acute agitation in the emergency department
16052934|NCT02504450|Drug|Alternative medications|Medication given to treat acute agitation in the emergency department
16052935|NCT02504437|Biological|BMMSCs|
16052936|NCT02504424|Device|AeroForm Tissue Expander|The AeroForm Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.
16052937|NCT02504411|Device|Device Assisted Colonoscopy|This will be similar to the standard colonoscopy except the endocuff device will be used.
16052941|NCT02504385|Device|Virtual Reality Timocco|Timocco virtual reality system is a motion based comuter games that was designed for child development therpay. The children will play Timocco for 15 minutes every session.
16052942|NCT02504385|Other|Conventional OT intervention|Traditional Occupational Therapy intervention will be givven to the control group.
16052943|NCT02504372|Biological|pembrolizumab|
16052944|NCT02504372|Other|Placebo|
16052945|NCT02504359|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic peripheral blood stem cell transplantation
16052946|NCT02504359|Drug|Carmustine|Given BEAM chemotherapy
16052947|NCT02504359|Drug|Cytarabine|Given BEAM chemotherapy
16052948|NCT02504359|Drug|Etoposide|Given BEAM chemotherapy
16052949|NCT02504359|Drug|Ixazomib Citrate|Given PO
16052950|NCT02504359|Drug|Melphalan|Given BEAM chemotherapy
16052951|NCT02504359|Drug|Methotrexate|Given IV
16052952|NCT02504359|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo allogeneic peripheral blood stem cell transplantation
16052953|NCT02504359|Other|Quality-of-Life Assessment|Ancillary studies
16052954|NCT02504359|Drug|Tacrolimus|Given IV or PO
16052955|NCT02504346|Drug|AZD9291|
16052956|NCT02504333|Drug|nab-paclitaxel|Day 1-8-15: Intravenous, 125 mg/m2 over 30 minutes
16052957|NCT02504333|Drug|gemcitabine|Day 1-8-15: Intravenous, 1.000 mg/m2 over 30 minutes
16052958|NCT02504333|Drug|m-FOLFOX|Day 28 according to the dose levels stablished in Phase I
16052959|NCT02504333|Drug|nab-paclitaxel|Day 1-8-15: Intravenous 30 minutes according to the dose levels stablished in Phase I
16052960|NCT02504333|Drug|gemcitabine|Day 1-8-15: Intravenous 30 minutes according to the dose levels stablished in Phase I
16052961|NCT02504320|Drug|Febuxostat XR 80 mg Capsule F1|Febuxostat extended-release (XR) capsules formulation 1
16052962|NCT02504320|Drug|Febuxostat XR 80 mg Capsule F2|Febuxostat XR capsules formulation 2
16052963|NCT02504320|Drug|Febuxostat XR 80 mg Capsule F3|Febuxostat XR capsules formulation 3
16052964|NCT02504320|Drug|Febuxostat XR 80 mg Capsule F4|Febuxostat XR capsules formulation 4
16052965|NCT02504307|Device|Sirolimus Eluting Stent Inspiron|Angioplasty with Sirolimus Eluting Stent Inspiron implantation
16052966|NCT02504307|Device|Bare Metal Stent|Angioplasty with Bare Metal Stent Cronus implantation
16052967|NCT02504294|Biological|Epoetin Hospira Arm|Epoetin Hospira Arm: Epoetin Hospira will be administered intravenously (IV) per the analogous version of the Fresenius Medical Care North America (FMCNA) cMAB 1 (inclusive of version 1.0, 1.1,...)erythropoietin stimulating agents (ESA) dosing algorithm for Epoetin Hospira for 24 weeks. Subjects will have Epoetin Hospira initiated using the same ESA dose level and frequency of administration for Epogen prior to randomization into the trial. Subjects will also receive IV iron per the FMCNA protocol that is standard of care at FMCNA clinics.
16052968|NCT02504294|Other|Standard of Care Arm|Standard of care arm: No interventions will be performed in this arm for the clinical study; and subjects will receive ongoing standard of care, which includes Epogen administered IV per the FMCNA cMAB 5 (inclusive of versions 5.0, 5.1,....) ESA dosing algorithm and IV iron per the FMCNA protocol that is standard of care, at FMCNA clinics during the contemporaneous 24 week period.
16052969|NCT02504294|Drug|IV Iron|Subjects will also receive IV iron per the FMCNA protocol that is standard of care at FMCNA clinics.
16052970|NCT02504268|Drug|Abatacept|
16052971|NCT02504268|Drug|Methotrexate|
16052972|NCT02504268|Other|Abatacept Placebo|
16052973|NCT02504268|Other|Methotrexate Placebo|
16052974|NCT02504255|Biological|Biological samplings|Blood, urine and faecal sampling every 3 months
16052975|NCT02504255|Other|Questionnaires|patients fill several questionnaires every month to assess stress and adaptation parameters
16052976|NCT02504242|Device|Inject BMP|
16052977|NCT02504242|Procedure|Locally Harvested Bone|
16052978|NCT02504229|Biological|autologous dendritic cells co-cultured with cytokine-induced killer cells|
16052979|NCT02504229|Drug|Gimeracil and Oteracil Porassium Capsules|
16052980|NCT02504229|Drug|Oxaliplatin|
16052981|NCT02504216|Drug|Rivaroxaban (Xarelto, BAY59-7939)|2.5 mg, twice daily, orally, tablet
16052982|NCT02504216|Drug|Rivaroxaban-Placebo|matching placebo, twice daily, orally, tablet
16052983|NCT02504203|Biological|BCG-Denmark 1331 (Statens Serum Institute)|See above
16052984|NCT02504177|Drug|novel oral anticoagulant for 30 days|novel oral anticoagulant includes 'dabigatran,Pradaxa®', 'rivaroxaban,Xarelto®', and 'apixaban, Eliquis®'.
16052985|NCT02504177|Drug|novel oral anticoagulant for 24 hour|novel oral anticoagulant includes 'dabigatran,Pradaxa®', 'rivaroxaban,Xarelto®', and 'apixaban, Eliquis®'.
16052986|NCT02504164|Drug|midazolam 0.02mg/kg|
16052987|NCT02504164|Drug|No premedication|No premedication before sedation for endoscopic submucosal dissection
16052988|NCT02504151|Drug|Cannabidiol|
16052989|NCT02504151|Drug|Placebo|
16052990|NCT02504138|Drug|Desflurane balanced anesthesia|Desflurane balanced anesthesia induced with thiopental sodium, remifentanil and atracurium and maintained with remifentanil target controlled infusion and desflurane inhalation
16052991|NCT02504138|Drug|Propofol total intravenous anesthesia|Propofol total intravenous anesthesia induced with propofol, remifentanil and atracurium and maintained with remifentanil and propofol target controlled infusion
16052992|NCT02504125|Drug|Tranexamic Acid|1 g of tranexamic acid in 100 mL of normal saline intravenously approximately 15 minutes before incision
16052993|NCT02504125|Drug|Normal saline|100 mL of normal saline intravenously approximately 15 minutes before incision
16052994|NCT02504112|Other|there is no intervention|
16052995|NCT02504099|Drug|ombitasvir/paritaprevir/ritonavir and dasabuvir|Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet
16052996|NCT02504099|Drug|ombitasvir/paritaprevir/ritonavir|Tablet; ombitasvir coformulated with paritaprevir and ritonavir
16052997|NCT02504099|Drug|ribavirin|Tablet
16052998|NCT02504086|Behavioral|Online Support|3 months online support, including access to online personal health record and 2.5 hours of online video teleconsultations with certified health professionals
16052999|NCT02504073|Other|No intervention|No intervention
16053000|NCT02504060|Drug|Starch Placebo|
16053001|NCT02504060|Drug|N-acetyl-D-glucosamine|
16053002|NCT02504047|Procedure|T-Cell replete haplo-transplant|Infusion of haploidentical related donor peripheral blood stem cells following myeloablative conditioning (fludarabine 200 mg/m2, busulfan 12.8 mg/kg and total body irradiation (TBI) 400 centigray -or- fludarabine 200 mg/m2, busulfan 9.6 mg/kg). GVHD prophylaxis will be with cyclophosphamide 50 mg/kg/day x 2 on days 3 & 4, mycophenolate mofetil 1 gm p.o. bid days 5 - 35 and tacrolimus (5-15 ug/ml) days 5 - 100.
16053003|NCT02504034|Procedure|Transhepatic portosystemic shunt|Portal vein (PV) was punctured with a 22-gauge chiba needle. A 0.018-inch guidewire was advanced through the needle into PV lumen. The needle was exchanged and a 6-French sheath inserted over the wire. Then middle hepatic vein (MHV) was punctured with a 20-gauge reformed needle through the transhepatic sheath. Another 0.018-inch guidewire was advanced through the needle into right internal jugular vein and then snared out of body. A 0.035-inch, 260-cm-long stiff shaft wire was introduced through the transjugular sheath and manipulated into main portal vein (MPV) and then into SMV. The parenchymal tract was dilated with balloon catheter, then one or more bare metal stents and one or more covered stents were inserted to line the parenchymal tract.
16053004|NCT02504034|Device|6-French sheath|
16053005|NCT02504034|Device|22-gauge chiba needle|
16053006|NCT02504034|Device|260-cm-long stiff shaft wire|
16053007|NCT02504034|Device|Balloon catheter|
16053008|NCT02504034|Device|Bare metal stent|
16053009|NCT02504034|Device|Covered stent|
16053010|NCT02504021|Behavioral|Family Consultation|This intervention is based on psychoeducation, social support mobilization, and motivational interviewing techniques.
16053011|NCT02504008|Drug|AXS-02 (oral zoledronate)|Once weekly for 6 weeks
16053012|NCT02504008|Drug|Placebo|Once weekly for 6 weeks
16053013|NCT02503995|Behavioral|Physical Exercise Participation|
16053014|NCT02503982|Drug|prophylactic Valganciclovir|The common practice dose at Schneider Children's Medical Center dosing guidelines of valganciclovir is 17 mg/kg once daily for prophylaxis, with stratified dose reductions for impaired renal function. Max dose was 900 mg.
16053015|NCT02503969|Other|Exposure to having a long-term condition.|"Long-term conditions are self-reported: twelve named conditions are recorded, along with an other condition - these shall all be considered with the exception of the named condition cancer."
16053016|NCT02503956|Device|Perforated Punctal plugs|Perforated punctal plugs
16053017|NCT02503956|Procedure|Crawford tube insertion|
16053018|NCT02503956|Device|Crawford lacrimal tube|
16053019|NCT02503943|Drug|"Liraglutide and Mitiglinide"|"Liraglutide(1.2mg/d) and Mitiglinide (50mg, 3/d)"
16053020|NCT02503943|Drug|"Metformin and Mitiglinide"|"Metformin(500mg, 3/d) and Mitiglinide(50mg, 3/d)"
16053021|NCT02503943|Drug|"Mitiglinide"|"Mitiglinide (50mg, 3/d)"
16053022|NCT02503930|Device|Active tDCS|In this group subjects will receive 20 min of treatment.
16053023|NCT02503930|Device|Sham tDCS|In this group subjects will receive 20 min of sham stimulation.
16053024|NCT02503904|Procedure|Concomitant Tumescent Antibiotic Delivery & IV Delivery|Concomitant subcutaneous infiltration of a dilute antibiotics (cefazolin and metronidazole) in a dilute solution of tumescent lidocaine and epinephrine at the site of a proposed surgical incision.
16053025|NCT02503904|Device|Subcutaneous Tumescent Infiltration|Subcutaneous tumescent infiltration using HK tumescent infiltration cannulas and HK tumescent infiltration pump
16053026|NCT02503904|Drug|cecefazolin and metronidazole (in a dilute solution of tumescent lidocaine, epinephrin and sodium bicarbonate in 0.9% physiologic saline)|
16053027|NCT02503891|Device|MP-1 Polymer on Ceramic Articulation system|MP-1 Polymer liner on Ceramic head
16053028|NCT02503878|Device|Masimo Sedline brain function monitors|"Masimo Sedline brain function monitors are sensors (stickers) placed on a the forehead to monitor levels of sedation based on a bilateral 4-channel electroencephalogram (EEG). The purpose of this study is to observe the effectiveness of the Sedline monitor to detect the unilateral hemispheric EEG changes seen in Wada testing"
16053029|NCT02503865|Drug|Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin|Xenical (Orlistat) - 120 mg/day in integration of Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day
16053030|NCT02503865|Dietary Supplement|"Analimentary detoxication"|Vegetable and salt diet
16053031|NCT02503852|Device|Puregraft System|The Puregraft System prepares purified adipose tissue for subcutaneous scalp injection.
16053032|NCT02503852|Device|Celution System|The Celution System prepares adipose derived regenerative cells (ADRCs) for subcutaneous scalp injection.
16053033|NCT02503852|Procedure|Kerastem Therapy|The Kerastem Therapy is the subcutaneous scalp injection of purified adipose prepared with the Puregraft System enriched with ADRCs prepared from the Celution System.
16053034|NCT02503852|Procedure|Liposuction|Tissue collection involving the micro-harvest of subcutaneous adipose tissue.
16053035|NCT02503839|Drug|etoricoxib|cyclooxygenase-2 inhibitor. Anti-inflammatory
16053036|NCT02503839|Biological|H56:IC31|Therapeutic and prophylactic TB vaccine
16053037|NCT02503826|Drug|Sufentanil|low dose
16053038|NCT02503826|Drug|Sufentanil|moderate dose
16053039|NCT02503826|Drug|Sufentanil|high dose
16053040|NCT02503826|Drug|Midazolam|Midazolam 2 mg, sufentanil 0.5 mcg/kg, propofol 2 mg/kg, cisatracurium 2 mg/kg for induction, continuous infusion of propofol, remifentanil and cisatracurium to maintain bispectral index (BIS) value between 40 and 60 for maintenance.
16053041|NCT02503826|Drug|propofol|
16053042|NCT02503826|Drug|cisatracurium|
16053043|NCT02503813|Procedure|venous blood gas|Venous blood gas will be measured at the time of arterial blood gas measurement.
16053044|NCT02503787|Device|Spinal Cord Stimulation (SCS)|SCS programming options
16053045|NCT02503774|Biological|MEDI9447|Subjects will receive MEDI9447 until disease progression
16053046|NCT02503774|Biological|MEDI9447 and MEDI4736|Subjects will receive MEDI9447 and MEDI4736 until disease progression
16053047|NCT02503761|Drug|Meropenem.|Infants in both groups will receive a loading dose of 20 mg/kg/dose every 8 hours for sepsis and 40 mg/kg/dose every 8 hours in meningitis and pseudomonas infection
16053048|NCT02503748|Other|Online tutorial|website informing about treatment options in localized prostate cancer
16053049|NCT02503735|Drug|Sofosbuvir/Ledipasvir FDC|12 weeks treatment with Harvoni
16053050|NCT02503722|Other|Laboratory Biomarker Analysis|Correlative studies
16053053|NCT02503722|Drug|Sapanisertib|Given PO
16053054|NCT02503709|Drug|CDK Inhibitor AT7519|Given IV
16053055|NCT02503709|Other|Laboratory Biomarker Analysis|Correlative studies
16053056|NCT02503709|Drug|Onalespib|Given IV
16053057|NCT02503709|Other|Pharmacological Study|Correlative studies
16053058|NCT02503696|Device|Stool Collection Kit|Stool Collection Kit.
16053059|NCT02503683|Drug|ALN-AAT|Single or multiple doses of ALN-AAT by subcutaneous (sc) injection
16053060|NCT02503683|Drug|Sterile Normal Saline (0.9% NaCl)|calculated volume to match active comparator
16053061|NCT02503670|Behavioral|Psychoeducational modules to prevent/reduce depression|Psychoeducational learning modules and tools. Men will choose modules based on interest and need.
16053062|NCT02503670|Other|Control Group|Continue with standard care.
16053063|NCT02503657|Drug|tipelukast|A novel, orally bioavailable small molecule compound that demonstrates anti-inflammatory and anti-fibrotic activity
16053064|NCT02503657|Drug|Placebo|Excipients of MN-001/tipelukast
16053065|NCT02503644|Drug|IVA337|Capsules of 200mg IVA337
16053066|NCT02503644|Drug|Placebo|Identical capsules without active substance
16053067|NCT02503631|Device|Stool Sample Collection Kit|Stool sample collection kit
16053068|NCT02503605|Drug|Biosimilar recombinant FSH|Controlled ovarian stimulation with 150 IU/day biosimilar recombinant FSH
16053069|NCT02503605|Drug|Urinary FSH|Controlled ovarian stimulation with 150 IU/day urinary FSH
16053070|NCT02503592|Other|Vestibular testing|Patients who have received a cochlear implant within 90 days, and had vestibular testing pre-operatively, will undergo post-op vestibular testing
16053071|NCT02503579|Behavioral|physical training|physical activity program, 30 minutes
16053072|NCT02503566|Device|Optical coherence tomography|Optical coherence tomography performed during regular coronary angiography
16053073|NCT02503553|Behavioral|Option grid for cerebral aneurysm treatment|Patients will receive an option grid during the preoperative visit. They will be given the chance to read it and ask questions. The option grid will include head to head comparative answers for the two interventions available for cerebral aneurysms (surgical clipping and endovascular coiling). The interaction with the aneurysm surgeon will be voice recorded.
16053074|NCT02503553|Behavioral|Control|Patients will receive the standard information booklet for cerebral aneurysms during the preoperative visit. They will be given the chance to ask questions. The interaction with the aneurysm surgeon will be voice recorded.
16053075|NCT02503540|Drug|Aflibercept|Intravitreal aflibercept will be given q4 wks for 6 treatments and then q 8 weeks through month 12.
16053076|NCT02503527|Other|Diben 1.5 kcal HP|Continuous (24h) application according to a standardized enteral feeding protocol via nasogastric tube or percutaneous endoscopic gastrostomy (PEG); pump-assisted application (Charriére (CH) > 8), duration according to patient's tolerance and requirements for a maximum of 5 days. Dosage: 21 - 24 kcal/kg body weight/day (corresponding to 14 to 16 ml/kg body weight/day).
16053077|NCT02503527|Other|Fresubin HP Energy Fibre (1.5 kcal)|Continuous (24h) application according to a standardized enteral feeding protocol via nasogastric tube or percutaneous endoscopic gastrostomy (PEG); pump-assisted application (Charriére (CH) > 8), duration according to patient's tolerance and requirements for a maximum of 5 days. Dosage: 21 - 24 kcal/kg body weight/day (corresponding to 14 to 16 ml/kg body weight/day).
16053078|NCT02503501|Drug|Insulin glulisine|
16053079|NCT02503501|Drug|Placebo|Bacteriostatic 0.9% Sodium Chloride
16053080|NCT02503488|Behavioral|Narrative Exposure Therapy for Forensic Offender Rehab|See arm description.
16053081|NCT02503488|Behavioral|Treatment as Usual|See arm description
16053082|NCT02503475|Other|Real-Time fMRI|"Real-Time fMRI: AR, CR, Sham, and Free Strategy groups will be compared to determine the following:
~(1) whether a cognitive strategy improves rtfMRI neurofeedback to modulate brain activity and pain; (2) which strategy is most effective at individual and group levels at modulating brain activity and pain; and (3) whether the investigators can predict individual ability to modulate brain activity or pain using a particular strategy and applying mixed effects modeling of treatment efficacy using baseline measurements."
16053083|NCT02503475|Behavioral|CBT or MBSR|CBT/MBSR: The study will investigate whether CBT versus MBSR differentially enhance behavioral and neural indices of the ability to implement cognitive regulation (CR) and attention regulation (AR) during evoked pain in the lower back in participants with chronic low back pain. An additional wait list control (WL) group will be used to determine the effects of time on pain symptom severity and well-being.
16053084|NCT02503475|Device|Acupuncture|Acupuncture: The investigators will compare the efficacy and mechanisms of verum and sham electroacupuncture.
16053085|NCT02503462|Drug|Darunavir|darunavir 800 mg once daily will be first given together with ritonavir 100 mg once daily for one month (period 1) and then darunavir 800 mg once daily will be given together with cobicistat 150 mg once daily for one month (period 2). Afterwards, all patients will be switched back to darunavir/ritonavir (800/100 mg once daily).
16053086|NCT02503462|Drug|ritonavir|ritonavir 100 mg once daily will be used to boost darunavir 800 mg once daily (period 1).
16053087|NCT02503462|Drug|cobicistat|cobicistat 150 mg once daily will be used to boost darunavir 800 mg once daily (period 2).
16053088|NCT02503423|Drug|ASTX660|described above
16053089|NCT02503410|Behavioral|Usual care|Subjects receive standard physical therapy, including outpatient visits as prescribed by the treating clinician and home-based exercises based on recommendations by the physical therapist.
16053090|NCT02503410|Behavioral|Interactive gaming|Subjects receive a combination of standard physical therapy in the clinic and home-based exercises that they perform using the Valedo system.
16053091|NCT02503397|Device|Auditory brainstem evoked response (ABR)|Bilateral monaural auditory brainstem response (ABR) test would be recorded in each subject with a Bio-logic Navigator Evoked Response System (Bio-logic Systems, USA) between 24 and 48 hours after birth by an audiologist skilled in administering ABR to newborn infants. ABRs shall be performed using 80 dB nHL broadband click stimuli with insert earphones and with the subject lying supine in a quiet room and normal skin temperature. The clicks would be presented at a repetition rate of 29.9/second, and three runs of 2000 repetitions to be recorded for each ear. The 2 most replicable runs for each ear shall be averaged and used for analysis. Absolute latencies of waves I, III, V and IPL (I-III, III-V, and I-V) shall be measured and considered outcomes
16053670|NCT02499328|Drug|tremelimumab (treme)|tremelimumab
16053092|NCT02503371|Other|Blood coagulation anyalsis by Thromboelastogram|Two blood tests will be taken during routine tests from all parturient s undergoing IVF treatment before starting gonadotropins treatment (the first few days of menstruation) and at the height of hormone therapy prior to egg retrieval Coagulation parameters will be measured by the use of Thromboelastogram
16053093|NCT02503358|Other|Laboratory Biomarker Analysis|Correlative studies
16053094|NCT02503358|Drug|Paclitaxel|Given IV
16053095|NCT02503358|Other|Pharmacological Study|Correlative studies
16053096|NCT02503358|Drug|Selumetinib|Given PO
16053097|NCT02503345|Drug|ALLN-177 low dose|ALLN-177 1,500 units (1 capsule)/meal PO 3 times per day
16053098|NCT02503345|Drug|ALLN-177 mid dose|ALLN-177 3,000 units (2 capsules)/meal PO 3 times per day
16053099|NCT02503345|Drug|ALLN-177 high dose|ALLN-177 7,500 units (5 capsules)/meal PO 3 times per day
16053100|NCT02503345|Drug|Placebo|Placebo: 1, 2 or 5 capsules with meals PO 3 times per day
16053101|NCT02503332|Drug|Pegcetacoplan|
16053102|NCT02503332|Other|Sham Procedure|
16053103|NCT02503319|Drug|Tranexamic Acid|"2 vials ( =1 gram) of Tranexamic Acid oral administered within 5 minutes from the delivery (third stage after labor)
~2 vials (=1 gram ) of Tranexamic Acid administered slow intravenous infusion within 5 minutes from the delivery (third stage after labor)"
16053104|NCT02503319|Drug|Tranexamic Acid|2 vials ( =1 gram) of Tranexamic Acid slow intravenous infusion administered within 5 minutes from the delivery (third stage after labor)
16053105|NCT02503319|Drug|Oxytocin|2 vials (=10 IU/International Unit) of oxytocin administered intramuscularly within 5 minutes from the delivery (third stage after labor)
16053106|NCT02503306|Drug|AVANAFIL|Pharmaceutical form:tablets Route of administration: oral
16053107|NCT02503306|Drug|placebo|Pharmaceutical form:tablets Route of administration: oral
16053108|NCT02503293|Device|Chrono Super PID then Generic Syringe-Gammanorm|"Each patient will receive the study treatment of Gammanorm using each of the two studied delivery devices according to the sequence randomly assigned based on a cross-over design:
~• pump and then syringe
~The use of automatic, programmable, compact pumps (such as CRONO SUPER PID) allows patients to remain mobile without interrupting their activities. Patients can infuse several sites simultaneously with infusion rates of up to 40 mL/h at 2 to 4 sites (abdomen, thighs, upper arms, lower back).
~Rapid and manual administration of SCIg using a syringe could therefore represent an alternative method by decreasing the duration of administration (around 10 minutes per injection at 1 or 2 sites simultaneously). The injection is self-administered by the patient. The infusion rate usually is 1 to 2 mL/min. The use of low viscosity products could facilitate injection"
16053109|NCT02503293|Device|Generic Syringe then Chrono Super PID-Gammanorm|"Each patient will receive the study treatment using each of the two studied delivery devices according to the sequence randomly assigned based on a cross-over design:
~• syringe and then pump.
~The use of automatic, programmable, compact pumps (such as CRONO SUPER PID) allows patients to remain mobile without interrupting their activities. Patients can infuse several sites simultaneously with infusion rates of up to 40 mL/h at 2 to 4 sites (abdomen, thighs, upper arms, lower back).
~Rapid and manual administration of SCIg using a syringe could therefore represent an alternative method by decreasing the duration of administration (around 10 minutes per injection at 1 or 2 sites simultaneously). The injection is self-administered by the patient. The infusion rate usually is 1 to 2 mL/min. The use of low viscosity products could facilitate injection"
16053110|NCT02503280|Drug|Autologous hMSCs|Autologous hMSCs: 40 million cells/ml delivered in 0.5 ml injection volumes times 10 injections for a total of 2 x 10^8 (200 million) hMSCs.
16053111|NCT02503280|Drug|Autologous Human C-Kit CSCs II|Autologous hMSCs PLUS autologous C-Kit hCSCs: Mixture of 39.8 million hMSCs and 0.2 million C-Kit hCSCs/ml delivered in 0.5 ml injection volumes times 10 injections for a total of 1.99 x 10^8 (199 million) hMSCs and 1 million C-Kit hCSCs.
16053112|NCT02503280|Drug|Placebo|Placebo (ten 0.5 ml injections of phosphate-buffered saline [PBS] and 1% human serum albumin [HSA]).
16053113|NCT02503280|Device|Biosense Webster MyoStar NOGA Injection Catheter System|Biosense Webster MyoStar NOGA Injection Catheter System will be used to administer the study drug
16053114|NCT02503267|Other|none intervention|
16053115|NCT02503254|Other|CHTP 1.0|CHTP 1.0 ad libitum for 5 days in confinement
16053116|NCT02503254|Other|Conventional Cigarette (CC)|Subject's own preferred brand of CC ad libitum for 5 days in confinement
16053117|NCT02503241|Procedure|PEEP INCREMENTAL|PEEP was progressively increased by steps of 2 cmH2O every 60 second until the end-expiratory transpulmonary pressure became positive between 0-2 cmH2O.
16053118|NCT02503241|Procedure|PEEP DECREMENTAL|Lung recruitment maneuver (LRM) is a transitory and controlled increase in airway pressure to open collapsed alveoli. LRM is the first step of the PEEP DECREMENTAL method. After LRM, PEEP is systematically decreased, in small decrements, until the best respiratory system mechanics is identified.
16053119|NCT02503228|Procedure|Standard of care osteochondral and or meniscal allograft transplantation|Standard of care osteochondral and or meniscal allograft transplantation
16053120|NCT02503215|Device|Compression Stockings|To evaluate the effects of compression stockings on fluid shift and sleep apnea in hemodialysis patients with obstructive sleep apnea
16053121|NCT02503202|Biological|V920 Consistency Lot A|V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot A, live, attenuated, sterile solution for intramuscular injection
16053122|NCT02503202|Biological|V920 Consistency Lot B|V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot B, live, attenuated, sterile solution for intramuscular injection
16053123|NCT02503202|Biological|V920 Consistency Lot C|V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine consistency Lot C, live, attenuated, sterile solution for intramuscular injection
16053124|NCT02503202|Biological|V920 High-dose Lot|V920 (rVSV-ZEBOV-GP) Ebola Zaire vaccine high-dose lot, live, attenuated, sterile solution for intramuscular injection
16053125|NCT02503202|Biological|Placebo to V920|Sodium chloride 0.9%, sterile solution for intramuscular injection
16053126|NCT02503189|Drug|KCT-0809 ophthalmic solution|
16053127|NCT02503189|Drug|Placebo|
16053128|NCT02503176|Drug|KCT-0809 ophthalmic solution|
16053129|NCT02503163|Drug|KCT-0809 ophthalmic solution|
16053299|NCT02501928|Drug|Fesoterodine BIC 4 mg|Fesoterodine BIC 4 mg tablet once daily for 28 weeks
16053302|NCT02501902|Drug|Nab-Paclitaxel|Nab-paclitaxel IV dosing on Days -2, 6, and 13 of Cycle 1, and on Days 1, 8, and 15 of subsequent cycles.
16053130|NCT02503150|Biological|APDC + Chemotherapy|Patients in Arm APDC+Chemotherapy receive maximum 12 cycles (14days/cycle) mFOLFOX6 chemotherapy. Each cycle chemotherapy consist of Oxaliplatin at 85mg/ m2 infused for 2 hours only on day 1,and Leucovorin at 400 mg/m2 was administered intravenously for 2 hours, followed by continuous intravenous administration of 5-Fluorouracil at 400 mg/m2 (2.4g/m2 for 46 hours).On day 8 of cycle1-3 and 7-9, patients also receive APDC vaccine infusion in 100ml saline. After 12 cycles, patients in Arm APDC+chemotherapy will receive 5-Fluorouracil /Leucovorin (Leucovorin at 400 mg/m2/day administered intravenously for 2 hours, intravenous bolus of 5-Fluorouracil at 400 mg/m2 , followed by continuous intravenous administration of 5-Fluorouracil at 1200 mg/m2/d for 2 days, repeated every 2 weeks) plus APDC therapy (once every 3 months). Treatments will continue unless disease progression, intolerable toxicity or patients withdrawal).
16053131|NCT02503150|Drug|Chemotherapy|Patients in Arm Chemotherapy receive maximum 12cycles (14days/cycle) mFOLFOX6 chemotherapy. Each cycle chemotherapy consist of Oxaliplatin at 85mg/ m2 infused for 2 hours only on day 1, and Leucovorin at 400 mg/m2 was administered intravenously for 2 hours, followed by continuous intravenous administration of 5-Fluorouracil at 400 mg/m2 (2.4g/m2 for 46 hours). After 12 cycles, patients in Arm chemotherapy will receive only 5-Fluorouracil /Leucovorin (Leucovorin at 400 mg/m2/day administered intravenously for 2 hours, intravenous bolus of 5-Fluorouracil at 400 mg/m2 , followed by continuous intravenous administration of 5-Fluorouracil at 1200 mg/m2/d for 2 days, repeated every 2 weeks). Treatments will continue unless disease progression, intolerable toxicity or patients withdrawal).
16053132|NCT02503137|Drug|Topical SM04554 solution|
16053133|NCT02503137|Drug|Topical Vehicle solution|
16053134|NCT02503124|Behavioral|Single night's wake therapy|Eligible patients are assisted in maintaining total sleep deprivation during one night
16053135|NCT02503124|Device|Bright light|Bright light according to patients´ own circadian rhythm each morning for a week.
16053136|NCT02503124|Other|Treatment as usual - inpatient care|All patients are admitted due to severe depression and are under observation and most receive antidepressive medication and if necessary anxiolytic/antipsychotic medication.
16053137|NCT02503124|Other|Informative meeting|A short sleep hygiene consultation.
16053138|NCT02503124|Drug|Treatment as usual - medicine|Since all patients are admitted due to a severe mental illness, they will receive medication according to indication. Most patients have already tried more than one antidepressant at the time of admission. In cases of severe anxiety, anxiolytics are prescribed but this is kept to a minimum.
16053139|NCT02503111|Device|The Hyfrecator ® 2000 Electrosurgical System|Lesion is ablated by the The Hyfrecator ® 2000 Electrosurgical System. During electrocautery (EC) with The Hyfrecator, a gentle brushing technique occurs and the tissue is removed with forceps.
16053140|NCT02503111|Other|Observation Alone|No treatment to AIN-2 or AIN-3, only active surveillance.
16053141|NCT02503098|Behavioral|Recovery Record adaptive smartphone application|
16053142|NCT02503098|Behavioral|Recovery Record standard smartphone application|
16053143|NCT02503085|Drug|Nurofen for Children®|
16053144|NCT02503085|Drug|Algifor Dolo Junior®|
16053145|NCT02503072|Behavioral|Small lottery prizes based on adherence|Clients coming for clinic visits have their MEMS data extracted, and if they show 95% adherence or higher are eligible to draw a number (1-6) out of a closed bag without looking; if they draw a '6' they win a small prize.
16053146|NCT02503072|Behavioral|Small lottery prizes based on timely clinic visits|Clients coming for clinic visits have their patient booklet checked to confirm that they came on their scheduled day; if so, they are eligible to draw a number (1-6) out of a closed bag without looking; if they draw a '6' they win a small prize.
16053147|NCT02503046|Other|Estimation of Pentraxin3|5ml of blood to be collected from each subject, centrifuged, to separate the plasma for estimation of Pentraxin3 (Quantikine ELISA)
16053148|NCT02503046|Genetic|Estimation of P.Gingivalis levels|Pooled plaque sample will be collected and sent for DNA Extraction by PCR for assessment of levels of PGingivalis
16053149|NCT02503033|Drug|HMPL-523|Oral administration, once daily
16053150|NCT02503020|Dietary Supplement|Preterm infants formula A|Group A will receive a preterm infants formula supplemented with AA (0.6%) and DHA (0.3%) until they have three months corrected age. At 3 and 6 months of corrected age, we changed the type of milk according to the nutritional requirements, but maintained the same ratio of AA and DHA (2/1) until one year corrected age.
16053151|NCT02503020|Dietary Supplement|Preterm infants formula B|"Group B will receive other Preterm infants formula very similar, but with AA (0.3%) and DHA (0.3%) also until they have three months corrected age.
~At 3 and 6 months of corrected age, we changed the type of milk according to the nutritional requirements, but maintained the same ratio of AA and DHA (1/1) until one year corrected age."
16053152|NCT02503007|Dietary Supplement|Placebo|
16053153|NCT02503007|Dietary Supplement|HMB-FA|
16053154|NCT02502994|Drug|GEN0101|
16053155|NCT02502981|Drug|Spironolactone|25mg orally once a day for 40 weeks
16053156|NCT02502981|Drug|Chlortalidone|25mg orally once a day for 40 weeks
16053157|NCT02502968|Drug|Cytarabine|
16053158|NCT02502968|Drug|BL-8040|
16053159|NCT02502968|Drug|Placebo (for BL-8040)|Powder for solution for injection manufactured to mimic BL-8040
16053160|NCT02502955|Procedure|Comparison autopsy methods|Comparison of post-mortem angiography/virtual autopsy and medical autopsy
16053161|NCT02502942|Behavioral|Upper Airway Muscle Exercise|Patients will use an individualized oral retainer device for upper airway muscle training exercises daily for 20 minutes each day (10 minutes in the morning and 10 minutes in the afternoon/evening) for 6 weeks.
16053162|NCT02502942|Behavioral|Sham Exercise|Patients will be given an individualized oral retainer device and instructed to do deep breathing exercise twice daily for 6 weeks.
16053163|NCT02502929|Behavioral|Social Services|
16053164|NCT02502929|Behavioral|Lifestyle|
16053165|NCT02502929|Behavioral|Lifestyle Plus Medication Therapy Management|
16053166|NCT02502903|Drug|BIV009|
16053167|NCT02502903|Other|Placebo|
16053168|NCT02502877|Drug|Midazolam|The investigators will administer 0,05mg/kg of midazolam, being 2/3 administered before the neuraxial block and 1/3 after.
16053331|NCT02501720|Procedure|Contracture release and application of FTSG|Post burn flexion contractures will be released and full thickness skin graft(FTSG) will be applied.
16053332|NCT02501694|Other|Auscultation|Electronic stethoscope
16053169|NCT02502877|Drug|Propofol|The investigators will administer 0,033mg/kg of midazolam before the neuraxial block, and immediately after installation of the block the investigators will start a propofol TCI pump (Schnider model) with an effect concentration set at 1mcg/mL. This pump will be turned off at the end of the surgery.
16053170|NCT02502877|Drug|Standard|The investigators will administer to every patient: cefazolin 2g iv bolus, ketorolac 30 mg iv bolus, pantoprazole 40 mg iv bolus, paracetamol 1g iv perfusion (initiated 30 minutes before the end of surgery).
16053171|NCT02502877|Device|SpotOn|Central temperature will be monitored with the SpotOnTM3MTM device from entering till leaving the operating room, through a sensor placed in the patient's forehead
16053172|NCT02502864|Drug|Standard of Care: Docetaxel|Pharmacokinetic(PK)-guided docetaxel. Cycle 1: 75 mg/m^2, intravenously (IV) on Day 1 for 60 minutes. Beginning with cycle 2, the docetaxel dose will be individually adjusted before each cycle.
16053173|NCT02502864|Drug|Standard of Care: Cyclophosphamide|Cycle 1: 600 mg/m^2, via IV on Day 1 for 30 minutes. The cyclophosphamide dose will not be changed unless dictated by toxicity.
16053174|NCT02502864|Other|Function Assessment of Cancer Therapy (FACT) Surveys|Participants will complete the FACT-Taxane and FACT-Breast quality of life assessment written surveys at baseline, during each chemotherapy cycle, and 3-5 weeks following the last cycle in which PK monitoring was performed.
16053175|NCT02502851|Device|Rotational Atherectomy|Calcified lesion preparation using rotational atherectomy before implantation of the Orsiro drug eluting stent
16053176|NCT02502851|Device|Cutting/Scoring Balloon|Calcified lesion preparation using cutting/scoring balloons before implantation of the Orsiro drug eluting stent
16053177|NCT02502825|Other|methacholine|methacholine (0.03,0.06,0.125,0.5,1.0,2.0,4.0,8.0,16.0 mg/ml),Canada
16053178|NCT02502825|Device|Wright Nebulizer|nebulized for 2 minutes with an output of 0.13ml/min
16053179|NCT02502825|Device|Devilbiss646 Nebulizer|nebulized for 2 minutes with an output of 0.13ml/min
16053180|NCT02502812|Drug|Clop F1|A single oral dose of clopidogrel (bisulfate) 75 mg tablet will be administered with approximately 240 mL water in fasted state.
16053181|NCT02502812|Drug|Clop F2|A single oral dose of clopidogrel (bisulfate) 75 mg tablet will be administered with approximately 240 mL water in fasted state.
16053182|NCT02502812|Drug|Innovator|A single oral dose of clopidogrel (bisulfate) 75 mg tablet will be administered with approximately 240 mL water in fasted state.
16053183|NCT02502799|Behavioral|Brief Early Intervention|Adolescents receive 5 individual sessions designed to strengthen the following skills: problem-solving, resisting peer pressure, and coping with emotions. Parents join portions of 3 sessions.
16053184|NCT02502799|Behavioral|Parent Training with Adolescent Cognitive Behavioral Therapy|Participants receive 12 family sessions with individual adolescent, parent, and joint adolescent and parent time. Includes additional parent training in behavioral modification, adolescent and parent contracting, and adolescent decision-making skills.
16053185|NCT02502799|Drug|Methylphenidate|Adolescents will receive methylphenidate.
16053186|NCT02502786|Biological|humanized anti-GD2 antibody|
16053187|NCT02502786|Drug|GM-CSF|
16053188|NCT02502773|Drug|Hydroxethyl starch|
16053189|NCT02502760|Behavioral|Physical Exercise Program|Physical exercises personalized by a kinesiologist consisting of walking or stationary bike and elastic band exercises.
16053190|NCT02502760|Dietary Supplement|Whey Protein Isolate Powder|"Nutritional counselling is given to patients to ensure their daily proteins and energy requirements are met. Whey Protein Isolate Powder (Immunocal) is provided.
~Immunocal1.5g/kg PO (by mouth) per day separated in 2 daily doses"
16053191|NCT02502760|Behavioral|Relaxation Techniques|Relaxation techniques consisting of breathing exercises and using a relaxation CD.
16053192|NCT02502747|Drug|rhu G-CSF|rhu G-CSF will be administered 5 µg/kg twice daily for 5 days, subcutaneously
16053193|NCT02502747|Drug|optimal standard of care|Optimal standard of care
16053194|NCT02502747|Procedure|Myocardial Contrast Echocardiography|Myocardial Contrast Echocardiography with sulphur hexafluoride.
16053195|NCT02502734|Drug|Fluticasone furoate|FF will be provided as a dry powder inhaler containing 50 μg of FF as a dry white powder per blister, to be inhaled orally via ELLIPTA.
16053196|NCT02502734|Drug|Placebo|Placebo will be provided as dry powder inhaler containing placebo as a dry white powder per blister, to be inhaled orally via ELLIPTA.
16053197|NCT02502734|Drug|Salbutamol|Salbutamol will be provided as a inhaler.
16053198|NCT02502721|Drug|DWC20151|
16053199|NCT02502721|Drug|DWC20152|
16053200|NCT02502708|Drug|Indoximod|Indoximod will be administered orally twice daily.
16053201|NCT02502708|Drug|Temozolomide|Temozolomide will be administered on days 1-5 of every 28 day cycle.
16053202|NCT02502708|Radiation|Conformal Radiation|Conformal radiation will be administered on days 3-7 of induction cycle.
16053203|NCT02502708|Drug|Cyclophosphamide|Cyclophosphamide will be administered orally daily.
16053204|NCT02502708|Drug|Etoposide|Etoposide will be administered orally daily.
16053205|NCT02502695|Other|VATS-associated best practices|
16053206|NCT02502682|Drug|Sage 2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation|Daily bathing.
16053207|NCT02502669|Drug|Finasteride 23.5 mg tablets|
16053208|NCT02502669|Drug|Finasteride 33.5 mg tablets|
16053209|NCT02502669|Drug|Placebo tablets|
16053210|NCT02502643|Drug|OK-432 pleurodesis|1.Pain medications (if no contraindications) Before half hour; Bain (IM ,0.15mg / kg). 2. Make the patient supine position 3. Near the body of patient's chest tube is the injection site disinfection with the alcoholic Betadine and alcohol repeated three times.4. 20 cc of 2% lidocaine hydrochloride (400 mg) was instilled into the pleural cavity through the chest tube 5. A solution of 30 cc of normal saline containing 5 KE of OK-432 (KE Z Klinische Einbeit; 1 KE contains 0.1 mg of dried cocci).6. Inject air 20 cc 7. The injection site will cover with op site and the rubber tube that connecting the chest tube and chest bottle was raised 40-60 cm above the patient to trap the sclerosing agent but allow air to pass 8. Patients will reposition (left and right side)every 30 minutes in 2 hours
16053300|NCT02501915|Device|Kinesio Taping|Group A received the application of KT from muscle Origin to Insertion and group B Insertion to Origin, with both groups taped the nondominant limb and the dominant limb was used as control group. Diferent tensions will be applied with the tape to see its possible different affect in the outcomes.
16053211|NCT02502643|Drug|normal saline pleurodesis|Make the patient supine position , Near the body of patient's chest tube is the injection site disinfection with the alcoholic Betadine and alcohol repeated three times.injected a solution of 30 cc of normal saline , and then injected into 20 cc air to the rubber chest tube , so that normal saline can completely into the chest, the injection site will cover with op site, use a rubber band to the rubber chest tube for hanging from the patient's body 40-60 cm high.Patients will reposition (left and right side)every 30 minutes in 2 hours
16053212|NCT02502630|Device|microwave ablation|pulmonary metastases from colorectal cancer are destructed/ablated using microwave ablation
16053213|NCT02502617|Dietary Supplement|medical nutrition|The participants are expected to improve their body weight with 10-30% during a closely monitored inpatient-treatment comprising nutritional rehabilitation.
16053214|NCT02502604|Behavioral|Goal Management Training|Goal management training sessions will be 2 hours in length and focus on learning skills that will assist in planning, carrying out, and monitoring goal-directed behaviours.
16053215|NCT02502591|Drug|Pudendal Nerve Block|An injection of local anaesthetic (3 ml of 0.25% bupivacaine) will be administered around the trunk of the pudendal nerve.
16053216|NCT02502578|Drug|CNT-01 500 mg capsule|After being informed about the study and potential risks, all patients giving written informed consent undergo screening tests to determine eligibility for study enrollment. On Day 1, patients who meet the eligibility criteria will start taking CNT-01 500mg orally three times daily for 14 days. On Day 15, patients will take CNT-01 500 mg only once after blood drawing.
16053217|NCT02502565|Other|Uric acid level|
16053218|NCT02502552|Other|blood specimen|blood specimen
16053219|NCT02502539|Procedure|Controlled physical activity|
16053220|NCT02502526|Device|Centurion® Vision System, 45° Balanced Tip|
16053221|NCT02502526|Device|Centurion® Vision System, 45° MFK Tip|
16053222|NCT02502526|Device|lnfiniti® Vision System, 45° MFK Tip|
16053223|NCT02502526|Device|INTREPID® Ultra infusion sleeve|
16053224|NCT02502526|Device|Ultra infusion sleeve|
16053225|NCT02502513|Behavioral|Brief computerized intervention|"Computer game Tetris"
16053226|NCT02502500|Drug|Celecoxib|
16053227|NCT02502500|Drug|AKB-6548|
16053228|NCT02502487|Procedure|Dorsal Penile Nerve Block|Dorsal penile nerve block with 0.33% ropivacaine using 22-G needle in the sub-pubic space at the base of the penis
16053229|NCT02502487|Drug|Ropivacaine|0.33% Ropivacaine administered around dorsal penile nerve using 22-G needle in the sub-pubic space at the base of the penis
16053230|NCT02502487|Drug|Tetracaine|1% Tetracaine gel instilled into urethra
16053231|NCT02502474|Other|Staphylococcus aureus carriage|nasal, throat, rectal and groin sampling with swabs. Colonic sampling by colonic biopsy
16053232|NCT02502461|Procedure|cuff palpation|Inflated endotracheal tube cuff palpated through anterior extra-thoracic trachea while tube is gently moved to place the cuff midway between cricoid and sternal notch.
16053233|NCT02502448|Procedure|Acute normovolemic hemodilution (ANH)|applying acute normovolemic hemodilution (ANH) by using HES 130/0.4 of 5 ml/kg before the initiation of cardiopulmonary bypass
16053234|NCT02502448|Drug|hydroxyethyl starch (HES 130/0.6)|
16053235|NCT02502422|Device|Classic laryngeal mask airway|"measurement of head and neck
~Ht,Wt,BMI, neck circumference above a thyroid cartilage, mandible circumference( from the lower part of earlobe-mandible angle-mentum-mandible angle to the lower part of earlobe), neck length (mastoid tip~sternal notch), modified mallampati classification under sitting position, thyromental distance.
~laryngeal mask airway insertion and measuring cuff pressure by pressure transducer
~# 4.0 for female, #5.0 for male
~initial cuff volume(air) : maximum volume recommended by the manufacturer
~check pressure : if it exceed 60cmH20, we will remove air until 60cmH20
~remove air until gas leak occured around the cuff under airway pressure 15cmH20, fresh gas flow 6liters/min. Check the volume and pressure just before leakage occured."
16053236|NCT02502409|Other|Standard care with blood and urine sample collection|
16053237|NCT02502396|Other|Retrospective Chart Review|Retrospective chart review study to evaluate Rivaroxaban's utilization in cancer patients for venous-thromboembolism (VTE) or non-valvular atrial fibrillation (NVAF). Study conducted from from January 1, 2012 to November 7, 2016 at MD Anderson Cancer Center in Houston, Texas.
16053238|NCT02502383|Behavioral|ACTION PAC|Adolescents enrolled in ACTION PAC will meet with SBHC providers. SBHC providers will use Motivational Interviewing to motivate students to adopt strategies for improving nutrition and increasing physical activity. All participants will receive annual BMI results discussion with providers. Overweight/Obese adolescents will meet with providers for 16 sessions over 2 years.
16053239|NCT02502383|Behavioral|Comparison|Annual BMI results will not be discussed with participants in comparison schools; however, a letter containing BMI results and obesity prevention recommendations will be sent to parent/guardians.
16053240|NCT02502370|Drug|observation alone|
16053241|NCT02502370|Drug|LV5FU2|
16053242|NCT02502370|Drug|FOLFOX|
16053243|NCT02502357|Other|Healing Statements|"Before the patient in the experimental group is placed under general anesthesia, the study staff member will repeat 5 times:
~Following this operation, [the participant] will feel very comfortable and [the participant] will heal very well.
~Toward the end of the surgery, the study staff member will say 5 times:
~The operation has gone very well. Following the operation, [the participant] will be hungry. [The participant] will be thirsty and urinate easily."
16053244|NCT02502344|Behavioral|healthy lifestyle|food control and intensive exercise to lose weight
16053245|NCT02502344|Drug|Metformin|use metformin to reduce insulin resistance
16053246|NCT02502331|Biological|Test Oral Cholera Vaccine|Thimerosal free, manufactured at 600 L scale killed bivalent (O1 and O139) whole cell-oral cholera vaccine (WC-OCV) manufactured by Eubiologics Co., Ltd.
16053247|NCT02502331|Biological|Euvichol®|Licensed, manufactured at 100 L scale killed bivalent (O1 and O139) whole cell-oral cholera vaccine (WC-OCV) manufactured by Eubiologics Co., Ltd.
16053248|NCT02502318|Procedure|Video-thoracoscopy|
16053249|NCT02502318|Procedure|thoracotomy|
16053250|NCT02502305|Behavioral|liveonline course|physical activity and healthy diet are targeted and should be enhanced, health literacy (HL) in older people should be improved
16053301|NCT02501902|Drug|Palbociclib|Palbociclib oral dosing on Days 1 to 21 of each 28-day cycle.
16053333|NCT02501681|Other|priming solution during cardiovascular surgery|
16053251|NCT02502292|Behavioral|Fotonovela|"Comparing fotonovela brochure to traditional brochure, as a template communicative behaviors embedded in a picture story where the older people could use before and during primary care consultations with their GP. Relevant communicative behaviors will include 'asking questions', 'expressing lack of or misunderstanding', 'expressing uncertainty', 'expressing preferences and needs' and other relevant communicative behaviors which are based on communication theory / literature and on the output of the focus group discussions.
~The researchers will randomly assigned the participants into four groups as described earlier. Mainly to identify the outcomes of the comparison between fotonovela and traditional brochure in both traditional hard-copy and in tablet."
16053252|NCT02502279|Device|Engström Datex-Ohmeda ICU Ventilator|patients will be mechanically ventilated and a vital capacity manoeuvre for lung inflation will be done by increasing the PIP to 35 cmH2o for 15 seconds followed by PEEP until extubation.
16053253|NCT02502279|Device|Postoperative CPAP mask|patients will be mechanically ventilated and a vital capacity manoeuvre for lung inflation will be done by increasing the PIP to 35 cmH2o for 15 seconds followed by PEEP until extubation and a CPAP mask will be applied immediately postoperative.
16053262|NCT02502253|Drug|grape seed polyphenolic extract, resveratrol|Bioactive Dietary Polyphenol Preparation (BDPP) is a combination of two nutraceutical preparations (grape seed polyphenolic extract [GSE], and resveratrol) that contain abundant concentrations of polyphenols.
16053263|NCT02502227|Behavioral|Mindfulness|Mindfulness training practices aim to foster attention and acceptance toward one's present moment experience. Mindfulness consists of two components-- (1) deploying attention to monitor one's moment-to-moment experience, and (2) fostering an attitude of acceptance toward one's moment-to-moment experience
16053264|NCT02502201|Other|six-minute walk study indoors|Performance of a six-minute walk test according to American Thoracic Society standard.
16053265|NCT02502201|Other|six-minute walk study outdoors|Performance of a six-minute walk test.
16053266|NCT02502188|Drug|CC-90005|
16053267|NCT02502188|Drug|Placebo|
16053268|NCT02502175|Drug|opium|Opium tincture (10mg/ml), manufactured by Daroupakhsh.co, Tehran, Iran.
16053269|NCT02502175|Drug|methadone|Methadone (5mg/ml), manufactured by Daroupakhsh.co, Tehran, Iran.
16053270|NCT02502162|Drug|LDN|
16053271|NCT02502162|Drug|Placebo|Sugar pill
16053272|NCT02502149|Biological|rFVIIIFc|As per arm description
16053273|NCT02502136|Procedure|carbon dioxide insufflation during endoscopy|Efficacy and safety study of carbon dioxide insufflation instead of air during sedated endoscopy
16053274|NCT02502136|Procedure|Room air insufflation during endoscopy (Placebo)|Efficacy and safety study of carbon dioxide insufflation instead of air during sedated endoscopy
16053275|NCT02502123|Other|No Intervention|No intervention was administered in this study.
16053276|NCT02502110|Drug|rosuvastatin|All recruited patients with paroxysmal atrial fibrillation will be randomly allocated to receive oral rosuvastatin 20mg/day or blank control from 7 days before ablation and last for 3 months.
16053277|NCT02502097|Drug|Gefapixant|Gefapixant 50 mg tablet, administered by mouth
16053278|NCT02502097|Other|Placebo|Matching placebo to gefapixant, tablet administered by mouth
16053279|NCT02502084|Device|3NT flexible endoscope|The nasal anatomy will be accessed and viewed with the device during functional endoscopic sinus surgery (FESS) procedure.
16053280|NCT02502071|Drug|sodium bicarbonate|All participants will receive 2 doses of 1950mg sodium bicarbonate
16053281|NCT02502058|Device|Densah Bur™ , osseodensification|Densah™ bur (Versah Osseodensification Company™) is used to prepare dental implant sites, in human subjects, by compacting (osseodensification ) bone vs. removing bone to create the opening in the jaw bone into which the dental implant is then placed. This osseodensification process results in increased bone-ridge width, increased compact bone in the outer wall of the prepared sites, and; it is believed, increases implant stability.
16053282|NCT02502045|Device|Morning Simulated Sunlight|Timed morning simulated sunlight (Philips Wake Up Light, Model HF3520) peaking at 300 lux delivered over a 40 minute ramp between 5-9 a.m. for 14 consecutive days
16053283|NCT02502045|Device|Non-therapeutic Red Light|Non-therapeutic red light control at 5 lux will be used as the control condition
16053284|NCT02502032|Drug|Cisatracurium|Different groups received different pretreatments of cisatracurium.
16053285|NCT02502019|Device|HEMOBLAST Bellows|HEMOBLAST™ Bellows is intended for use in surgical procedures as an adjunct to hemostasis when control of bleeding by conventional procedures is ineffective or impractical.
16053286|NCT02502006|Drug|Celecoxib|
16053287|NCT02502006|Drug|Naproxen|
16053288|NCT02502006|Drug|Placebo|
16053289|NCT02501980|Biological|Biomarker testing and Ultrasonography|
16053290|NCT02501967|Other|COMET|The intervention consists of completion of the tool by means of a telephone interview prior to the primary care visit and provision of the tool's output to the patient and PCP.
16053291|NCT02501954|Drug|Cisplatin|Given IV
16053292|NCT02501954|Drug|Carboplatin|Given IV
16053293|NCT02501954|Drug|Paclitaxel|Given IV
16053294|NCT02501954|Radiation|Radiation Therapy|Undergo Radiation Therapy
16053295|NCT02501941|Drug|ketamine|Ketamine will be used as a sedative alternative to other more conventional sedatives (such as propofol, versed, or dexmedetomidine) in 6 hour blocks of time. Ketamine will be titrated at the bedside based on clinically desired Riker Sedation-Agitation Scale target. Both groups will receive the drug in this multiple crossover design. The only difference between groups is which sedation regimen is started first to minimize any bias related to differences in physiology in the early post-operative phase.
16053296|NCT02501928|Drug|Fesoterodine PR 4 mg|Fesoterodine 4 mg tablet once daily for 28 or 40 weeks
16053297|NCT02501928|Drug|Fesoterodine PR 8 mg|Fesoterodine PR 8 mg tablet once daily for 28 or 40 weeks
16053298|NCT02501928|Drug|Fesoterodine BIC 2 mg|Fesoterodine BIC 2 mg tablet once daily for 28 weeks
16053303|NCT02501889|Behavioral|Walnut-rich weight loss diet|Composition of prescribed diets will be based on individual preferences, with the goal of reduced energy intake and increased energy expenditure. During the 6-month intervention, study subjects will participate in individualized counseling and group sessions, with in-person, telephone, email and text message contacts to provide support and behavioral guidance and strategies. Walnuts will be provided to participants. The overall content of the intervention consists of key elements of cognitive-behavioral therapy for obesity. The physical activity component emphasizes planned aerobic exercise, increased physical activity in the lifestyle, and strength training.
16053304|NCT02501889|Behavioral|Standard weight loss diet|Composition of prescribed diets will be based on individual preferences, with the goal of reduced energy intake and increased energy expenditure. During the 6-month intervention, study subjects will participate in individualized counseling and group sessions, with in-person, telephone, email and text message contacts to provide support and behavioral guidance and strategies. The overall content of the intervention consists of key elements of cognitive-behavioral therapy for obesity. The physical activity component emphasizes planned aerobic exercise, increased physical activity in the lifestyle, and strength training.
16053305|NCT02501876|Other|There is a retrospectiv observational study. No intervention|There is a retrospectiv observational study. No intervention will be performed
16053306|NCT02501863|Drug|Femoral nerve block with ropivacaine+fentanyl|Ropivacaine+fentanyl are used for continuous femoral nerve block, spinal anesthesia, IV-PCA with hydromorphone
16053307|NCT02501863|Drug|Femoral nerve block with ropivacaine|Ropivacaine is used for continuous femoral nerve block, spinal anesthesia, IV-PCA with hydromorphone
16053308|NCT02501850|Drug|Liraglutide|Treatment with liraglutide, exenatide or lixisenatide
16053309|NCT02501850|Drug|metformin|Treatment with metformin and/or sulphonilurea
16053310|NCT02501837|Drug|Syntocinon-Spray|Intranasal administration of 24 IU Oxytocin
16053311|NCT02501824|Other|anthroposophic therapeutic speech|anthroposophic therapeutic speech
16053312|NCT02501811|Biological|Mesenchymal Stem Cells (MSC)|15 transendocardial injections of 0.4ml MSCs administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
16053313|NCT02501811|Biological|c-kit+ cells|15 transendocardial injections of 0.4ml c-kit+ cells administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
16053314|NCT02501811|Biological|Placebo (Plasmalyte A)|15 transendocardial injections of 0.4ml placebo administered to the left ventricle via NOGA Myostar injection catheter (single procedure)
16053315|NCT02501798|Drug|Methylphenidate|Drug: Methylphenidate
16053316|NCT02501798|Drug|Placebo|Drug: Placebo
16053317|NCT02501785|Behavioral|Caregiver Reaction Assessment (CRA)|
16053318|NCT02501785|Behavioral|The Caregiver Quality of Life - Cancer (CQOLC)|
16053319|NCT02501772|Device|acupressure by ankle band|
16053320|NCT02501759|Procedure|3 Tesla Magnetic Resonance Imaging|Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast
16053321|NCT02501759|Radiation|Gadodiamide|Given IV
16053322|NCT02501759|Procedure|Multiparametric Magnetic Resonance Imaging|Undergo diagnostic multiparametric endorectal MRI with gadodiamide contrast
16053323|NCT02501759|Procedure|Transrectal Biopsy|Undergo transrectal MRI-guided biopsy
16053324|NCT02501759|Procedure|Ultrasound-Guided Prostate Biopsy|Undergo TRUS-guided biopsy
16053325|NCT02501746|Other|Usual Clinical Care|Non-hypertensive diabetic individuals will not be pharmacologically treated for BP reduction; those with BP 120-139/80-89 will be advised on lifestyle changes to reduce BP as recommended by the 2013 Standards of Medical Care in Diabetes. Care will be provided to each individual at the rural health facility by a rural clinician mentored by the CDM Program, including regular monthly consultation, vital signs, physical examination, and prescriptions. CHWs will assist with linkage and retention of patients to the care program, and provide health education. The 12-month follow-up BP will be measured in the rural health facility, in order to mimic real-world practice. If the patient does not present to the rural health facility for the 12-month visit, the local CHW will trace the patient at home and will check the 12-month BP at that time, again consistent with real-world conditions.
16053326|NCT02501746|Other|Group Medical Visits|"The CHW will facilitate a group discussion about a self-care or health education topic chosen by the group while the rural clinician reviews the BP, sugar, and adherence data to determine a clinical recommendation as per the CDM clinical algorithm. which is communicated to each individual patient privately by the rural clinician in a five-minute breakout time. The rural clinician will not change the regimen for non adherence but instead will use the breakout time to assess barriers to adherence and try to help the patient identify solutions to those barriers.The breakout time can also be used to perform a physical examination or other assessments as clinically required. After all patients have had individual consultations with the rural clinician, the entire group re-convenes for a closing session, which consists of a question-and-answer period and determination of the next session's self-care or health education topic."
16053327|NCT02501746|Other|Microfinance Groups|The rural clinician and the CHW will organize a meeting with AMPATH's Safety Net Program representatives, who will introduce the concept of microfinance groups, the potential benefits, and encourage the formation of new groups to meet monthly. The microfinance groups need to incorporate an element of self-selection and self-formation, so that individuals have the freedom to choose with whom they will create a group. The groups are therefore formed voluntarily, and usually along geographical boundaries, which facilitates participation, retention, and meeting logistics.
16053329|NCT02501720|Procedure|post burn flexion contractures release under tourniquet control|post burn flexion contractures will be released under tourniquet control
16053330|NCT02501720|Procedure|post burn flexion contractures release using tumescent solution|post burn flexion contractures will be released using tumescent solution
16053376|NCT02501317|Behavioral|Kari Bo protocol|Group exercises to pelvic floor rehabilitation
16053334|NCT02501655|Device|phase 1 - jet nebulizer|Aerosol generators diethilene penta-acetic triamine technetium (99mTc-DTPA) with radioactivity of 1 millicuries (Noble et al., 2007) mixed with 0.9% saline solution with a total volume of 4 ml using jet nebulizer (NS - mark) and 8l/min of the oxygen
16053335|NCT02501655|Device|Phase 2- mesh nebulizer|Aerosol generators diethilene penta-acetic triamine technetium (99mTc-DTPA) with radioactivity of 1 millicuries (Noble et al., 2007) mixed with 0.9% saline solution with a total volume of 2 ml using vibrating mesh inhaler with valved chamber adapter (Aerogen Solo with Ultra Adapter, Aerogen Ltd).
16053338|NCT02501629|Drug|Reslizumab|Reslizumab 110 mg was administered by qualified study personnel as subcutaneous injections in the upper arm(s) once every 4 weeks for a total of 6 doses. Drug was supplied in pre-filled syringes.
16053339|NCT02501629|Drug|Placebo|Placebo was administered by qualified study personnel as subcutaneous injections in the upper arm(s) once every 4 weeks for a total of 6 doses. Drug was supplied in pre-filled syringes.
16053340|NCT02501629|Drug|Non-Oral Corticosteroid (non-OCS) Asthma Medication|Participants continue using their non-OCS background asthma medications without change during the study's treatment period.
16053341|NCT02501629|Drug|Oral Corticosteroid (OCS)|After screening and prior to study start, the participant's OCS dose was adjusted to determine the minimal effective OCS requirement.
16053342|NCT02501616|Drug|Metformin|
16053343|NCT02501616|Drug|Dapagliflozin|
16053344|NCT02501603|Drug|afatinib|Afatinib 40mg daily oral administration
16053345|NCT02501603|Drug|paclitaxel|Paclitaxel 80mg/m2 IV weekly (day 1,8,15)
16053346|NCT02501577|Device|SAD 1|Placement and fiberoptic control
16053347|NCT02501577|Device|SAD 2|Placement and fiberoptic control
16053348|NCT02501564|Drug|Naproxen Sodium Codeine|One tablet twice a day
16053349|NCT02501564|Drug|Placebo|One tablet twice a day
16053350|NCT02501551|Drug|regorafenib|160mg regorafenib once daily with a low fat breakfast for the first 21 days of each 28-day cycle
16053351|NCT02501538|Device|Transcutaneous O2 device|A portable device that delivers continuous diffusion of oxygen.
16053352|NCT02501525|Device|RIRS with ureteral access sheath|Ureteral access sheath will be used during RIRS.
16053353|NCT02501525|Device|RIRS without ureteral access sheath|Ureteral access sheath will not be used during RIRS.
16053354|NCT02501499|Other|Breastfeeding Buddies|a 2 hour breastfeeding workshop and if mother chooses, she is matched with a buddy who will contact her and offer breastfeeding support
16053355|NCT02501486|Other|ACTH stimulation test|An ACTH stimulation test will be done
16053356|NCT02501473|Drug|G100|GLA is a fully synthetic toll-like receptor-4 (TLR4) agonist
16053357|NCT02501473|Drug|Pembrolizumab|PD-1 Inhibitor
16053358|NCT02501473|Drug|Rituximab|Rituximab (anti-CD20 antibody)
16053359|NCT02501460|Other|Educational handouts|Both groups of participants will receive educational handouts that explain the Physical Activity Guidelines for Americans at enrollment.
16053360|NCT02501460|Other|Resistance training|"Individuals in both groups will participate in an individually tailored progressive resistance training program 3 times/week for 24 weeks. During weeks 1-4 participants will be supervised twice a week tapering to once a week in weeks 5-12, every other week in weeks 13-20 and then once a month in weeks 21-24 by an American College of Sports Medicine (ACSM) Certified Exercise Specialist (trainer).
~Adherence: To assure fidelity and safety of the resistance training component of the intervention, participants will initially be supervised more frequently They will complete an exercise log for each of their sessions. As the supervision level for exercise is tapered, participants may receive reminders to exercise and take their supplement/placebo via text, phone, or e-mail as needed."
16053361|NCT02501460|Dietary Supplement|Supplementation|A medical quality protein supplement powder will be mixed with water or a sugar free drink mix to be taken daily within 60 minutes of training on exercise days or mid-morning on non-exercise days.
16053362|NCT02501460|Other|Placebo|A placebo that appears to be identical to the medical quality protein supplement powder will be mixed with water or a sugar free drink mix to be taken daily within 60 minutes of training on exercise days or mid-morning on non-exercise days.
16053363|NCT02501447|Behavioral|Guided audio-visual relaxation|
16053364|NCT02501434|Drug|Continuous Low-Dose IV Unfractionated Heparin Infusion|Continuous intravenous infusion of a low-dose unfractionated heparin drip
16053365|NCT02501421|Biological|tuberculosis vaccine|Live recombinant influenza vectored tuberculosis vaccine
16053366|NCT02501421|Biological|Placebo|Buffer
16053367|NCT02501408|Device|propriofoot prosthesis|Adaptation of the device and evaluation after 1 month at home using the studied device
16053368|NCT02501395|Other|No intervention, observational|
16053369|NCT02501369|Behavioral|Self-directed Teen Triple P|Manualised parenting programme that parents will complete at home. This involves reading weekly modules of the manual and completing small exercises to practice the skills taught. These include strategies to help build positive relationships between parent and child, helping parents to effectively manage challenging childhood behaviours, and providing parents with the skills to support their child's independence and independent management of their cystic fibrosis.
16053370|NCT02501356|Dietary Supplement|ISOThrive Supplement|Consumption of ISOThrive supplements for 3 months
16053371|NCT02501356|Dietary Supplement|Placebo Supplement|Consumption of Placebo supplement (Magnesium stearate or methylcellulose) for 3 months
16053372|NCT02501343|Drug|Sodium Bicarbonate Oral Capsule|Sodium bicarbonate 1680 mg will be administered prior to the meal
16053373|NCT02501343|Drug|Placebo|Sodibic-matching placebo (Stenlake Compounding Chemist, NSW, Australia) will be administered prior to the meal on a different day 1 to 2 weeks apart
16053374|NCT02501330|Drug|Bosutinib|The recommended adult dose of bosutinib is 500 mg orally once daily with food. For newly-diagnosed chronic phase CML, the recommended dose is 400 mg. The dose may be adjusted appropriately according to the patient's condition; however, the maximum dose is 600 mg once daily.
16053375|NCT02501317|Behavioral|Active Perineal Rehabilitation protocol|Active Perineal Rehabilitation Protocol available in http://www.perineo.info/wordpress/book-active-perineal-rehabilitation/
16053752|NCT02498678|Procedure|Tetanus|tetanic electric stimulation
16053377|NCT02501304|Device|ReVENT Sleep Apnea System|The ReVENT Sleep Apnea System consists of minimally invasive biocompatible devices that are placed into the tongue base and palate of patients with obstructive sleep apnea
16053378|NCT02501291|Drug|Thalidomide|
16053379|NCT02501278|Biological|INO-3112 vaccine|"INO-3112 i.e. the combination of VGX-3100 and INO-9012, specifically:
~VGX-3100 (HPV16 and HPV18 E6-E7 DNA vaccine) will be administered at 3 mg per plasmid (6 mg total DNA)
~INO-9012 (IL-12 DNA plasmid) will be administered at 1 mg per dose will be administered using the CELLECTRA® electoporation device"
16053380|NCT02501278|Radiation|Radiotherapy (Extrernal beam radiotherapy + brachytherapy)|"The whole pelvis will be irradiated with 45 - 50.4 Gy in 25-28 fractions in fractions of 1.8 Gy over 5 weeks daily.
~Those patients with pelvis positive and/or para-aortic positive lymph nodes should be treated with an elective dose to the para-aortic area of 45 Gy in fractions of 1.6-1.8 Gy in 25-28 fractions.
~Pelvic and para-aortic nodes known to contain gross/macroscopically visible disease and heavily involved parametria or tumor areas that may lie beyond the high-dose range of brachytherapy should be treated with additional small volume boost of EBRT to a total dose of 60-65 Gy using a combination of either sequential and/or concomitant boost. Fractions of 1.8-2 Gy can be used in the sequential boost."
16053381|NCT02501278|Drug|Cisplatin chemotherapy|Cisplatin chemotherapy will be administered i.v. at a dose of 40 mg/m2 (total 5 cycles during week 1-5) weekly in concomitance with RT with the total dose not to exceed 70 mg per week.
16053382|NCT02501265|Behavioral|Varenicline Standard Protocol|"4 weeks pre-TQD: Start Placebo Varenicline
~1 week prior to TQD: Switch to Active Varenicline
~1 week prior to TQD: Start Placebo Bupropion Varenicline + Placebo Bupropion to 12 weeks post TQD"
16053383|NCT02501265|Behavioral|Nicotine Patch Standard Protocol|"4 weeks pre-TQD: Start Placebo Nicotine Patch TQD: Start active Nicotine Patch
~1 week prior to TQD: Start Placebo Bupropion Nicotine Patch + Placebo Bupropion to 12 weeks post TQD"
16053384|NCT02501265|Drug|Varenicline Adaptive Protocol|"VARENICLINE RESPONDER 4 weeks pre-TQD: Start Varenicline 2 weeks pre-TQD: DOES reduce cigs/day by > 50% 1 week pre-TQD: Start Placebo Bupropion Varenicline + Placebo Bupropion to 12 weeks post TQD
~VARENICLINE NON-RESPONDER 4 weeks pre-TQD: Start Varenicline 2 weeks pre-TQD: DOES NOT reduce cigs/day by > 50%
~1 week pre-TQD: Start active Bupropion Varenicline + Bupropion to 12 weeks post TQD"
16053385|NCT02501265|Drug|Nicotine Adaptive Protocol|"NICOTINE PATCH RESPONDER 4 weeks pre-TQD: Start Patch 2 weeks pre-TQD: DOES reduce cigs/day by > 50% 1 week pre-TQD: Start Placebo Bupropion Patch + Placebo Bupropion to 12 weeks post TQD
~NICOTINE PATCH NON-RESPONDER 4 weeks pre-TQD: Start Patch 2 weeks pre-TQD: DOES NOT reduce cigs/day by > 50%
~1 week pre-TQD: Start Bupropion Patch + Bupropion to 12 weeks post TQD"
16053386|NCT02501252|Procedure|trained midwives and nurses working in the community to provide skilled SBA services|After the completion of all the necessary preparations, trained CORNs will be deployed for ten months in their respective study sites (arms) to provide the required RH services at home, community and health posts.
16053387|NCT02501239|Behavioral|Accept Yourself!|
16053388|NCT02501239|Behavioral|Weight Watchers|
16053389|NCT02501226|Other|Treatment as usual|Treatment as usual consisting of clinical management including assessment of the psychiatric symptoms and subsequent prescription of antidepressants.
16053390|NCT02501226|Behavioral|ENVIE psychoeducational program|"The intervention will consist of 9 weekly, 90 min sessions led by two animators. The program ENVIE will provide:1.Presentation of the program 2.Education on depressive symptoms. 3.Information about the causes leading to depression. 4.The depression's consequences. 5.Teaching about the last neurobiological and neuroanatomical knowledges about depression, through didactic presentations. 6.How to recognize his own mood state, the prodromal symptoms of relapse. 7.Didactic explanation of the neurobiological action of antidepressant, and other evidence-based medical treatments. 8 and 9. Recommendations about lifestyle and skills of behavioral activation.To enhance the active role of the patient, each session will be accompanied with homework for the patient.
~The sessions may be carried out remotely, by videoconference."
16053391|NCT02501213|Drug|Spironolactone (+/- Furosemide)|Administration of spironolactone alone 100 mg/day each morning, increased in increments of 100 mg / week to a maximum of 400 mg / day in the absence of efficiency. In case of ineffectiveness or hyperkalemia: addition of Furosemide 40 mg / day increased in increments of 40 mg / week to a maximum of 160 mg / day in the absence of efficiency.
16053392|NCT02501200|Drug|CKD-391|Investigational product is prescribed to all of randomized subjects for two times.
16053393|NCT02501200|Drug|Atrovastatin and Ezetimibe combination therapy|Investigational products are prescribed to all of radomized subjects for two times.
16053394|NCT02501187|Procedure|Levator advancement|A transcutaneous procedure in which the Levator palpebrae aponeurosis is advanced and attached to the tarsus.
16053395|NCT02501187|Procedure|Müller's muscle-conjunctival resection procedure|A transconjunctival procedure in which part of the muller muscle and conjunctiva are resected.
16053396|NCT02501187|Procedure|White line advancement|A transconjunctival procedure in which the Levator palpebrae aponeurosis is advanced and attached to the tarsus.
16053397|NCT02501161|Drug|insulin degludec/liraglutide|Injected subcutaneously (under the skin) once daily for 104 weeks. Dose individually adjusted.
16053398|NCT02501161|Drug|insulin glargine|Injected subcutaneously (under the skin) once daily for 104 weeks. Dose individually adjusted.
16053399|NCT02501148|Device|carotid artery stenting|Post-dilation of deployed self-expanding carotid stent with the Paladin Post-Dilation Balloon System with Integrated Embolic Protection
16053400|NCT02501135|Procedure|Femoral nerve block with ropivacaine or bupivacaine|
16053401|NCT02501122|Other|Pediatric Health Information System (PHIS), Partners for Kids (PFK) and Nationwide Children's Hospital Perioperative Database|Utilizing these databases to assess standards for quality of care measures in adenotonsillectomy patients.
16053402|NCT02501109|Drug|Aripiprazole|Healthy volunteers will receive Aripiprazole Oral Soluble Fim(OSF) 10mg orally a single of dose within 28 days
16053403|NCT02501096|Drug|Lenvatinib|Lenvatinib will be administered with water orally once a day (with or without food) continuously in 21-day treatment cycle.
16053404|NCT02501096|Drug|Pembrolizumab|Pembrolizumab will be administered as a dose of 200 mg Q3W, IV in 21-day treatment cycle.
16053405|NCT02501083|Other|no intervention|The study will not include any intervention.
16053406|NCT02501057|Behavioral|Clinician's Guide|An evidence-based, NIAAA-advocated approach to brief intervention for heavy drinking in primary care settings.
16053407|NCT02501057|Behavioral|Enhanced Motivational Interviewing|Brief motivational interview plus the use of a smart phone application to monitor alcohol use and health behaviors.
16053408|NCT02501057|Behavioral|Enhanced Clinician's Guide|An evidence-based, NIAAA-advocated approach to brief intervention for heavy drinking in primary care settings plus the use of a smart phone application to monitor alcohol use and health behaviors.
16053409|NCT02501031|Dietary Supplement|Ground flaxseed|2 tablespoons of ground flaxseed taken daily for approximately 50 days.
16053410|NCT02501018|Biological|CLBS12|Intramuscular transfusion of CLBS12.
16053411|NCT02501018|Drug|SOC|Standard of care (SOC) is defined as pharmacotherapy with approved drugs (e.g., antiplatelets, anticoagulants, and vasodilators including prostanoids).
16053412|NCT02501005|Procedure|VT ablation|Catheter ablation of ventricular tachycardia
16053413|NCT02500992|Procedure|Transrectal sigmoidectomy|
16053414|NCT02500979|Drug|Pramlintide acetate|Pramlintide acetate administered by a separate pump
16053415|NCT02500979|Drug|Placebo|Placebo administered by separate pump
16053416|NCT02500979|Drug|Lispro insulin U-100|Subjects will be stabilized on a separate insulin pump and administered lispro insulin throughout the study, except during both inpatient treatment periods (Visit 4 and Visit 5)
16053417|NCT02500979|Drug|Regular insulin U-100|Use during two in-patient treatment periods (visits 4 and 5) and administered by separate pump
16053418|NCT02500966|Device|DUDA device|Insertion DUDA device
16053419|NCT02500966|Procedure|LEEP|Loop Electrosurgical Excision Procedure
16053420|NCT02500953|Drug|ASP3325|
16053421|NCT02500953|Drug|Placebo|
16053422|NCT02500940|Drug|Cisplatin|Neoadjuvant chemotherapy regimen with cisplatin
16053423|NCT02500940|Drug|Fluorouracil|Neoadjuvant chemotherapy regimen with Fluorouracil
16053424|NCT02500940|Radiation|Radiation therapy|Intensity-Modulated Radiation Therapy
16053425|NCT02500940|Drug|Leucovorin|Neoadjuvant chemotherapy regimen with Leucovorin
16053426|NCT02500927|Drug|ASP8273 Capsules|oral
16053427|NCT02500927|Drug|ASP8273 Capsules A|oral
16053428|NCT02500914|Drug|SC-002|SC-002 will be administered by IV infusion over approximately 30 minutes every 3 weeks
16053429|NCT02500901|Drug|Enzalutamide|Following completion of 28-day lead-in cycle, enzalutamide 160 mg PO daily will continue to be administered in 28-day cycles until documented progression, unmanageable toxicity, or decision to discontinue for any reason.
16053430|NCT02500901|Drug|Niraparib|Niraparib will be administered daily in three dose-escalation cohorts of 6 subjects per dose levels of 100mg PO, 200mg PO or 300mg PO in 28-day cycles until documented progression, unmanageable toxicity, or decision to discontinue for any reason.
16053431|NCT02500888|Radiation|Radiosurgery|Only one radiation session of about 180 Gy in bilateral internal capsule.
16053432|NCT02500875|Device|PTNiA|
16053433|NCT02500875|Device|PTNiB|
16053434|NCT02500875|Device|PTN|
16053435|NCT02500849|Genetic|SB-728mR-HSPC Infusion 3 days following busulfan conditioning|
16053436|NCT02500836|Drug|Cocaine HCl 4% Topical Solution|Topical solution, up to 4 mL, is applied for 20 minutes via cotton or rayon pledget(s) to the accessible mucous membranes of the nasal cavities.
16053437|NCT02500836|Drug|Cocaine HCl 10% Topical Solution|Topical solution, up to 4 mL, is applied for 20 minutes via cotton or rayon pledget(s) to the accessible mucous membranes of the nasal cavities.
16053438|NCT02500836|Drug|Placebo Topical Solution|Topical solution, up to 4 mL, is applied for 20 minutes via cotton or rayon pledget(s) to the accessible mucous membranes of the nasal cavities.
16053439|NCT02500810|Drug|monosialoganglioside|40mg in the vein on day 1 - day 8 of each 21 days cycle. Number of Cycles: 2 cycles.
16053440|NCT02500797|Biological|Ipilimumab|Given IV
16053441|NCT02500797|Other|Laboratory Biomarker Analysis|Correlative studies
16053442|NCT02500797|Biological|Nivolumab|Given IV
16053443|NCT02500797|Other|Quality-of-Life Assessment|Ancillary studies
16053444|NCT02500784|Drug|Formoterol A|20mg/2mL, BID inhaler for 12 months: until progression or unacceptable toxicity develops.
16053445|NCT02500784|Other|Formoterol B (placebo)|2mL, BID inhaler for 12 months
16053446|NCT02500771|Behavioral|ABA therapy enhanced with V-Motive software|Tutors will use the V-Motive software to enhance their delivery of Applied Behavioral Analysis therapy.
16053447|NCT02500758|Procedure|Preparatory handwash|Preparatory handwash follows the UNE-EN 12791 standard using a diluted soft soap, 200g/1000g, made in community pharmacy service and sterilize in autoclave. Washing hands were prepared without use of a brush for 1 minute with 10 ml of soft soap. After being rinsed with running tap water, they are thoroughly dried with paper towels.
16053448|NCT02500758|Procedure|Preoperative surgical scrubbing using 3% PCMX|Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.
16053449|NCT02500758|Procedure|Preoperative surgical scrubbing using 4% CHG|Both hands were scrubbed using a sterile disposable surgical scrub brush with plastic bristles on one side and a foam sponge on the other side. The bristled side was used to scrub the entire hands, including all nails, palm and back of the hand, and interdigital spaces, and the foam side was used to rub between the fingers. Each side of each finger, between fingers and back al palm of the hand were rubbed for two and a half minute. Then, the forearms were rubbed from the wrist to the elbow, maintaining the hand highest than the arm, using a minute to wash each side. Both hands were rinsed by current water in an one-way (from the fingertips to the elbow), and wiped with a sterile disposable towel, including nails and interdigital spaces.
16053450|NCT02500732|Drug|Atomoxetine|40mg PO the night before and the morning of the study tilt table test.
16053451|NCT02500732|Drug|Placebo|oral placebo capsule designed to blind the atomoxetine intervention
16053566|NCT02500004|Procedure|Blood sampling|Systemic inflammatory profile: blood sampling.
16053452|NCT02500719|Device|Computational Model - Real-time Support Vector Machine|A support vector machine algorithm will be applied in real-time to fMRI data to identify distributed patterns of co-activated brain regions that specifically encode high emotional arousal (i.e,. high SCR) to the stress/trauma memory (note, this is equivalent to predictions of fitted Q-iteration in which the all actions are specified as zero, reward is equal to the support vector machine predicted arousal, and the discount factor of 0). The resulting idiosyncratic brain map would inform the neurofeedback phase in the next stage of fMRI data collection. This approach will first be piloted in the healthy participant group, then implemented in the PTSD participant group.
16053453|NCT02500706|Drug|Faster-acting insulin aspart|Injected subcutaneously (under the skin) three times daily for 26 weeks. Dose individually adjusted. Mealtime dosing is defined as injecting 0-2 minutes before the meal. Postmeal dosing is defined as injecting 20 minutes after the start of the meal.
16053454|NCT02500706|Drug|insulin aspart|Injected subcutaneously (under the skin) three times daily for 26 weeks. Dose individually adjusted. Mealtime dosing is defined as injecting 0-2 minutes before the meal.
16053455|NCT02500706|Drug|insulin degludec|Injected subcutaneously (under the skin) once daily for 26 weeks. Dose individually adjusted
16053456|NCT02500693|Biological|Isolation of circulating tumor cells (CTC) from veinous blood|Thirty ml of peripheral blood will be collected in buffered EDTA, maintained at 4°C, and processed within 1 hour for filtration. After blood filtration, the membrane will be gently washed with PBS, disassembled from the filtration module, and allowed to air-dry. The determination of CTC number present on filters will be carried out by combining four color immunofluorescent (anti-pancytokeratins/anti-vimentin/DAPI/anti-CD45) staining and cytomorphological examination after Diff-quick and Mayer Hemalun staining in three spots per patient sample. Imaging of immunofluorescent and cytological staining will be performed at x20 magnification using the automated Ariol system. CTCs are identified by relocating images of immunofluorescent and cytological staining.
16053457|NCT02500680|Biological|MER4101|
16053458|NCT02500680|Biological|Inactivated Influenza Vaccine|Fluzone quadrivalent Influenza Vaccine
16053459|NCT02500667|Drug|N91115|200 mg BID
16053460|NCT02500667|Drug|Rifampin|600 mg QD
16053461|NCT02500654|Device|Emdogain®|Surgery and Emdogain®
16053462|NCT02500654|Device|Surgery alone|Surgery alone
16053463|NCT02500641|Drug|Febuxostat 80/120mg/day|Starting dose and dose regimen of Febuxostat : the initial daily dose is 80 mg. In case the patient has the serum urate concentration > 6 mg/dl after 2 weeks of treatment the dose will be escalated to 120 mg and if tolerated will be maintained for the duration of the study.
16053464|NCT02500641|Drug|Allopurinol 100 up to 600mg/day|Starting dose and dose regimen of allopurinol : the initial daily allopurinol dose is 100 mg, to be increased by 100 mg every 2 weeks in patients with serum urate concentration >6 mg/dl. The maximum daily dose of allopurinol achievable in the study will depend on kidney function and tolerability, but will not exceed 600 mg.
16053465|NCT02500641|Drug|Colchicine|Colchicine 0.5 mg tablets.To prevent flares in the initial stages of treatment, patients will be treated for at least 6 months with colchicine 0.5 - 1 mg QD
16053466|NCT02500641|Drug|Naproxen|Naproxen sodium 550 mg film coated tablets. In case of colchicine intolerance patients will be treated for at least 6 months with Naproxen 550 mg BID and Omeprazole (20-40 mg once daily), if indicated to be used.
16053467|NCT02500641|Drug|Omeprazole|Omeprazole 20 mg capsules, co-administered to patients for gastric protection.
16053468|NCT02500628|Drug|Metformin|500 mg orally after baseline testing of heart rate
16053469|NCT02500615|Other|ECIG liquid vehicles|The ratio of propylene glycol and vegetable glycerin will be changed while all other factors of the electronic cigarette provided to participants will be held constant.
16053470|NCT02500602|Drug|doxazosin|active medication
16053471|NCT02500602|Drug|placebo|placebo pill
16053472|NCT02500589|Behavioral|Behavioral mood management|The mood-management sessions are informed by CBT and emphasize psycho-educational and skills-based approaches to CBT. CBT has been used extensively to address mood management. Specifically, SMK-MM enhancement includes behavioral activation, cognitive restructuring (working with automatic thoughts, problem solving, and behavioral skills (i.e., activity scheduling, relaxation training/controlled breathing). The SMK-MM-enhanced participant manual will also include additional worksheets developed for the investigator's pilot based on Lewinsohn's self-help guide to controlling depression. The main objective of the worksheets will be to provide Veterans with an opportunity to gain mastery over selected behavioral and cognitive skills thought to facilitate mood management. As is customary in CBT, homework based on the worksheets will be discussed during counseling calls.
16053473|NCT02500589|Other|Health education|"In the contact-equivalent health education condition, participants will receive parallel smoking cessation content on the same schedule as in the MM-enhanced arm; however, health education content will supplant the MM content. The educational content will be based on the VA National Center on Health Promotion and Disease Prevention's Health Living Messages on such topics as being safe, eating wisely, getting recommended immunization and screening tests, and being involved with the participant's health care. Participants also will receive chronic-disease-specific self-management information."
16053474|NCT02500576|Biological|Aldesleukin|Given IV or SC
16053475|NCT02500576|Drug|Cyclophosphamide|Given IV
16053476|NCT02500576|Drug|Fludarabine Phosphate|Given IVPB
16053477|NCT02500576|Other|Laboratory Biomarker Analysis|Correlative studies
16053478|NCT02500576|Biological|Pembrolizumab|Given IV
16053479|NCT02500576|Other|Quality-of-Life Assessment|Ancillary studies
16053480|NCT02500576|Biological|Therapeutic Tumor Infiltrating Lymphocytes|Given IV
16053481|NCT02500563|Other|Amino acid based infant formula|
16053482|NCT02500563|Other|Extensively hydrolyzed casein infant formula|
16053483|NCT02500563|Other|Mother's own breast milk|
16053484|NCT02500550|Biological|ATIR101|T-lymphocyte enriched leukocyte preparation depleted ex vivo of host alloreactive T-cells (using photodynamic treatment). Two intravenous infusions with 2x10E6 viable T-cells/kg approximately 42 days apart (unless the second dose is reduced or halted for safety reasons).
16053485|NCT02500550|Procedure|Haploidentical hematopoietic stem cell transplantation (HSCT)|"CD34-selected HSCT from a haploidentical donor. In order to prepare the patient for the HSCT one of the following myeloablative conditioning regimens is recommended:
~Total Body Irradiation (TBI) regime
~Non-TBI regime
~(See below for details)"
16053486|NCT02500550|Procedure|TBI regime|"Fractionated TBI 200 cGy twice daily for 3 days on Day -10 to -8 (1200 cGy in 6 fractions)
~Fludarabine 30 mg/m2 IV once daily for 5 days on Day -7 to -3
~Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7
~Anti-thymocyte globulin (ATG; Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV."
16053487|NCT02500550|Procedure|Non-TBI regime|"Fludarabine; 30 mg/m2 IV once daily for 5 days on Day -8 to -4
~Thiotepa; 5 mg/kg IV twice daily for 1 day on Day -7
~Melphalan; 60 mg/m2 IV once daily for 2 days on Day -2 and -1
~ATG (Thymoglobulin®); 2.5 mg/kg once daily for 4 days on Day -5 to -2, as a continuous IV infusion for 8 hours. During the course of ATG, patients will receive methylprednisolone 2 mg/kg/day IV."
16053488|NCT02500537|Device|Endo GIA™ Reinforced Reload with Tri-Staple™ Technology|Endo GIA™ Reinforced Reload with Tri-Staple™ Technology (Universal Handle)
16053489|NCT02500524|Drug|Cocamide diethanolamine|Topical lotion
16053490|NCT02500524|Drug|Permethrin|Topical creme rinse
16053491|NCT02500511|Biological|NmVac4-A/C/Y/W-135-DT™|no intervention in this study, received test vaccine in trial JN-NM-002
16053492|NCT02500498|Drug|Nulojix|
16053493|NCT02500485|Drug|SHR3824, SP2086|One 100-mg tablet of SP2086 once daily on Day 1,2,3,4 followed by two 10-mg tablets of SHR3824 once daily on Day 11,12,13,14, followed by one 100-mg tablet of SP2086 and two 10-mg tablets of SHR3824 on Day 15,16,17,18.
16053494|NCT02500472|Dietary Supplement|Kava|3 doses equaling 250 mg kavalactones per day. Participants will take 1 capsule three times daily at 8:00 (± 2 hours), 14:00 (± 2 hours) and 20:00 (± 2 hours) for 7 consecutive days.
16053495|NCT02500459|Drug|topotecan|intraparenchymally-administered topotecan will use the Cleveland Multiport Catheter to directly infuse topotecan into the tumor site of patients with suspected recurrent/progressive high grade glioma (HGG). This drug is already FDA approved to be administered intravenously.
16053496|NCT02500459|Device|Cleveland Multiport Catheter|The Cleveland Multiport Catheter will directly infuse topotecan into the tumor site of patients with suspected recurrent/progressive high grade glioma (HGG). Standard treatment is to adminsiter the drug intravenously.
16053497|NCT02500446|Drug|dolutegravir|Each film-coated tablet contains dolutegravir sodium equivalent to 50 mg dolutegravir.
16053498|NCT02500446|Other|Placebo|A film-coated tablet identical in appearance to the active drug tablet but not containing any dolutegravir or any other active ingredient
16053499|NCT02500433|Other|Device: Kinect-Xbox 360TM|Based around a webcam-style add-on peripheral for the Xbox 360 console, it enables users to control and interact with the Xbox 360 without the need to touch a game controller, through a natural user interface using gestures and spoken commands. Participants were asked to practice 30 minutes per day, 2 days per week for 2 months, added to their conventional treatment. The games used were Kinect Sports ITM, Kinect Joy RideTM and Kinect Disneyland AdventuresTM and involved balance and trunk movements, general and visual-manual coordination and limb tasks. Each subject followed instructions on the screen with the help of his physiotherapist, with points awarded based on degree and speed of movement and level of difficulty.
16053500|NCT02500433|Other|Conventional therapy|
16053501|NCT02500420|Other|Diagnosis examens|"Cardiac MRI: is usually recommended in the diagnosis or in the follow-up of the disease. The MRI will respect the standard protocol: cineMRI sequences, perfusion sequences, LGE sequences at 10 minutes after gadolinium injection. The investigators will realize some additional sequences: T1 mapping before and after gadolinium injection to study the diffuse fibrosis and stress perfusion sequences after injection of a vasodilatator (Persantine°).
~Exercice stress echocardiography: is realized almost systematically in all the diagnosis of HCM and it's very informative. The investigators will research left ventricular dysfunction: in particular segmentary hypokinesia and anomalies of deformation parameters (2D Strain) and the development of a dynamic left ventricular outflow obstruction or a mitral regurgitation at exercice."
16053502|NCT02500407|Drug|BTCT4465A (Mosunetuzumab) IV|Participants with B-cell NHL and CLL will receive BTCT4465A (Mosunetuzumab) via IV infusion.
16053503|NCT02500407|Drug|Atezolizumab|Participants assigned to an atezolizumab combination group will receive atezolizumab 1200 mg administered as an IV infusion in combination with BTCT4465A (Mosunetuzumab).
16053504|NCT02500407|Drug|BTCT4465A (Mosunetuzumab) SC|Participants with B-cell NHL and CLL will receive BTCT4465A (Mosunetuzumab) via SC injection.
16053505|NCT02500394|Procedure|Ionosteril|biomarker guided volume substitution with Ionosteril
16053506|NCT02500381|Drug|SRP-4045|SRP-4045 solution for IV infusion
16053507|NCT02500381|Drug|SRP-4053|SRP-4053 solution for IV infusion
16053508|NCT02500381|Drug|Placebo|SRP-4045 or SRP-4053 placebo-matching solution for IV infusion
16053509|NCT02500368|Device|silicone hydrogel lens (test)|contact lens
16053510|NCT02500368|Device|enfilcon A lens (control)|contact lens
16053511|NCT02500355|Procedure|Carpal Tunnel Release via limited approaches|Carpal tunnel release with partial excision of the flexor retinaculum via two small incisions.
16053512|NCT02500355|Procedure|Carpal Tunnel Release via standard approach|Carpal tunnel release with partial excision of the flexor retinaculum via the standard incision.
16053513|NCT02500355|Procedure|Endoscopic Carpal Tunnel Release|Carpal tunnel release under endoscope.
16053514|NCT02500355|Device|endoscope or an arthroscopic device|
16053515|NCT02500342|Drug|Levothyroxine|The intervention will start with Levothyroxine 50 mcg daily (reduced to 25 mcg in subjects <50 kg of body weight or if known coronary heart disease - previous myocardial infarction or symptoms of angina pectoris) vs. matching placebo; at 3 months, if the serum TSH level is <0.4 mU/L, dose will be reduced by 25 mcg; TSH >=0.4 and <4.6 mU/L, no change to dose; TSH >=4.6 mU/L, additional 25 mcg. The process will be repeated at 12 months, then annually; mock titration will be performed in the placebo group. The maximum possible dose of Levothyroxine which will be prescribed is 150 mcg (after 4 increments of 25 mcg at 3 months, 1, 2, 3 years; from the starting dose of 50 mcg).
16053516|NCT02500342|Drug|Placebo|"Control patients will obtain a placebo pill of the same characteristics as the intervention drug, and mock titration will be carried out identically to the intervention drug.
~Pharmaceutical composition of placebo (100 mg): Lactose monohydrate 66 mg, Maize starch 25 mg, Gelatin 5 mg, Croscarmellose sodium 3.5 mg, Magnesium stearate (vegetable source) 0.5 mg."
16053517|NCT02500329|Drug|Gemigliptin|Gemigliptin for 4 weeks
16053518|NCT02500329|Drug|Acarbose|Acarbose for 4 weeks
16053669|NCT02499328|Drug|AZD5069|AZD5069
16053519|NCT02500316|Drug|MOD-4023|Once weekly injection of long acting r-hGH (MOD-4023) provided as a solution for injection containing 20 or 50 mg/mL MOD-4023 in a single patient use, multi-dose, disposable pre-filled pen (PEN).
16053520|NCT02500277|Device|Cryoprobe pleural biopsy first|Four pleural biopsy specimens will be obtained using the flexible cryoprobe (ERBOCRYOCA, ERBE, Tubingen, Germany; outer diameter 1.9 mm, length 900 mm) followed by 6-10 pleural biopsy specimens obtained using the flexible thoracoscopic forceps (FB-55CR, Olympus Medical Systems, 2 mm diameter).
16053521|NCT02500277|Device|Flexible forceps biopsy first|Six to ten pleural biopsy specimens will be obtained using the flexible thoracoscopic forceps (FB-55CR, Olympus Medical Systems, 2 mm diameter) followed by four pleural biopsy specimens obtained using the flexible cryoprobe (ERBOCRYOCA, ERBE, Tubingen, Germany; outer diameter 1.9 mm, length 900 mm)
16053522|NCT02500264|Device|TENS|
16053523|NCT02500251|Drug|belimumab|Belimumab will be administered per study protocol.
16053524|NCT02500251|Drug|Bortezomib|Bortezomib will be administered per study protocol.
16053525|NCT02500251|Drug|Rituximab|Rituximab will be administered per study protocol.
16053526|NCT02500251|Drug|Plasmapheresis|Plasmapheresis will be administered per study protocol.
16053527|NCT02500238|Other|Saliva sample|All participants will provide a saliva sample.
16053528|NCT02500238|Other|Urine Sample|All participants will provide a urine sample.
16053529|NCT02500238|Other|Toe nail clippings|All participants will provide toe nail clippings.
16053530|NCT02500238|Other|Breath carbon monoxide test|All participants will provide breath carbon monoxide tests
16053531|NCT02500225|Drug|Etomidate|0.2 mg/kg etomidate
16053532|NCT02500225|Drug|Sevoflurane|8% Sevoflurane
16053533|NCT02500212|Drug|ENVARSUS®|
16053534|NCT02500212|Drug|ADVAGRAF®|
16053535|NCT02500199|Drug|Pyrotinib|Pyrotinib maleate, is provided as yellow, film-coated, immediate release tablets containing pyrotinib maleate at dosage strengths of 80 and 160 mg. Multiple tablets of pyrotinib will be administered daily to achieve targeted doses of pyrotinib: 320 mg, 400 mg, 480 mg, 560 mg and 640 mg. Tablets will be orally administered with water, once daily, 30 min after a meal.
16053536|NCT02500186|Drug|Luseogliflozin|Study patients orally receive luseogliflozin 2.5 mg s.i.d. before breakfast for 7 days from the 8th day of starting the study meal to the 14th day.
16053537|NCT02500186|Other|Meal containing different carbohydrate ratio and GI value|High GI meal containing 55% carbohydrate Low GI meal containing 55% carbohydrate High GI meal containing 40% carbohydrate
16053538|NCT02500173|Radiation|Radiation|Radiation therapy
16053539|NCT02500160|Device|Patient specific instrumentation (MRI)|
16053540|NCT02500160|Device|Patient specific instrumentation (CT)|
16053541|NCT02500147|Drug|Metformin|Metformin ER 500 mg once a day for one week and 1000 mg once a day for the remainder of the six months
16053542|NCT02500147|Drug|Placebo|One placebo pill per day for one week and then two placebo pills per day for the remainder of the six months
16053543|NCT02500134|Other|Optical coherence tomography study on limbus|Optical coherence tomography study on limbus
16053544|NCT02500121|Other|Placebo|Normal saline
16053545|NCT02500121|Drug|Pembrolizumab|Pembrolizumab, 200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or for up to 24 months
16053546|NCT02500108|Drug|Domperidone|"Current exposure to domperidone will be defined as a prescription dispensed within 30 days before the index date.
~Recent exposure to domperidone will be defined as a prescription dispensed between 31 and 90 days before the index date (without a dispensing during the 30 days period preceding index date).
~Past exposure to domperidone will be defined as a prescription dispensed between 91 and 365 days before the index date (without prescription in the 90 days period prior index date)."
16053547|NCT02500095|Other|Fasting|72 hours of fasting
16053548|NCT02500095|Drug|Saline|Concomitant saline during fasting
16053549|NCT02500095|Drug|Pegvisomant|Concomitant Growth hormone receptor blockade with Pegvisomant during fasting
16053550|NCT02500082|Drug|triheptanoin|Triheptanoin (UX007) is a medium chain triglyceride of three seven-carbon fatty acids (C7), on a glycerol backbone, with a molecular formula of C24H44O6. It is being evaluated as a substrate replacement therapy for the treatment of long-chain fatty acid oxidation disorders (LC-FAOD) and for the treatment of seizures associated with Glut 1 DS. Triheptanoin is metabolized to provide substrate replacement for both fatty acid metabolism and anaplerosis (replacement of TCA cycle intermediates) required to restore the efficient generation of energy and the net production of glucose in patients. The mechanism of action of triheptanoin in restoring energy metabolism is dependent on its medium-chain length as well as its odd-carbon properties. Triheptanoin is a highly purified form intended for oral administration.
16053551|NCT02500069|Other|placebo|infusion of tap water in all regions (duodenum, jejunum and ileum)
16053552|NCT02500069|Other|Casein (in duodenum)|infusion of protein in duodenum
16053553|NCT02500069|Other|Casein (in jejunum)|infusion of protein in jejunum
16053554|NCT02500069|Other|Casein (in ileum)|infusion of protein in ileum
16053555|NCT02500056|Device|Optilene LP mesh|Lichtenstein hernioplasty
16053556|NCT02500056|Device|Ultrapro mesh|Lichtenstein hernioplasty
16053557|NCT02500043|Drug|TAS-102|35 mg/m2/dose of TAS-102 orally, twice daily on days 1-5 and days 8-12 of each 28-day cycle.
16053558|NCT02500043|Drug|Placebo|35 mg/m2/dose of placebo orally, twice daily on days 1-5 and days 8-12 of each 28-day cycle.
16053559|NCT02500030|Procedure|Glossopharyngeal Breathing|Glossopharyngeal Breathing is a type of lung recruitment technique where the patients take a multiple inssuflations with their glossopharyngeal muscle.
16053560|NCT02500030|Procedure|Air Stacking|Air Stacking is a type of lung volume recruitment technique where insufflations are stacked in the lungs to maximally expand them, here done with a manual resuscitator.
16053561|NCT02500017|Dietary Supplement|Melatonin|5mg rapid release melatonin capsule
16053562|NCT02500017|Other|Placebo|matching placebo capsule
16053563|NCT02500004|Radiation|18F-FDG PET-MRI-imaging|BAT activity: 18F-FDG PET-MRI-imaging.
16053564|NCT02500004|Radiation|DXA scanning|Body composition: DXA scanning, D2O and MRI.
16053565|NCT02500004|Procedure|Abdominal subcutaneous adipose tissue biopsy|Inflammatory and metabolic profile of adipose tissue: abdominal subcutaneous adipose tissue biopsy.
16053567|NCT02500004|Other|Indirect calorimetry|Resting metabolic rate: indirect calorimetry.
16053568|NCT02500004|Device|Accelerometry|Physical activity level: accelerometry.
16053569|NCT02500004|Other|Double-labeled water|Body composition: DXA scanning, D2O and MRI. Total daily energy expenditure: double-labeled water.
16053570|NCT02499991|Behavioral|memory|keep track of social events in diary for memory recall. Used by treatment group
16053571|NCT02499978|Drug|Darunavir/Cobicistat|Fixed dose combination medication
16053572|NCT02499978|Drug|Dolutegravir|single tablet medication
16053573|NCT02499965|Drug|Ethyl Chloride Topical Aerosol Anesthetic|Sprayed on the skin for 5-8 seconds immediately before IV cannulation
16053574|NCT02499965|Drug|Nature's Tears Sterile Water|Sprayed on the skin for 5-8 seconds immediately before IV cannulation
16053575|NCT02499952|Drug|Pembrolizumab|200mg IV every 3 weeks until progressive disease, unacceptable toxicity, or after 52 weeks of therapy.
16053576|NCT02499939|Behavioral|Standard Care|Education and home exercises
16053577|NCT02499939|Other|Ultrasound Therapy|"Ultrasound is a therapeutic modality that is used by physical therapists to help reduce local tissue pain and inflammation. Ultrasound is applied using a round-headed wand or probe that is placed in direct contact with the patient's skin. Ultrasound gel is used on all surfaces of the ultrasound head to reduce friction and assist in the transmission of the ultrasonic waves. For the purposes of treatment for CIPN, the ultrasound will be applied for 5 minutes to each limb (right toes, left toes, right fingers, left fingers) at frequency of 3.0 megahertz (MHz) and an intensity of 0.7-0.8 watts per cm2.
~(For CIPN, the ultrasound will be administered at a lower intensity in order to avoid a heating effect on the tissues.)"
16053578|NCT02499926|Dietary Supplement|Arginine|"Graded arginine excess intake will start at 50mg/kg/d on study day 1 followed by 100 mg/kg/d on study day 2 till the level reaches 300mg/kg/d on study day 6.
~Consisting of oral consumption of eight hourly experimental meals per study day - Includes 4 tracer free experimental meals containing a mixture of free amino acids, calories from a flavored liquid and protein free cookies and 4- labeled amino acid experimental meals."
16053579|NCT02499913|Behavioral|breath alcohol monitoring|Daily breath alcohol monitoring
16053580|NCT02499913|Behavioral|contingency management|Participants can earn chance to win prizes for negative breath alcohol samples.
16053581|NCT02499900|Drug|Copaxone®|Subcutaneous Injections
16053582|NCT02499887|Drug|beclamethasone dipropionate|Inhaler
16053583|NCT02499887|Drug|albuterol|Inhaler
16053584|NCT02499887|Drug|Prednisone|Oral corticosteroid
16053585|NCT02499874|Drug|Efavirenz|oral Efavirenz 400mg
16053586|NCT02499874|Drug|tenofovir /emtricitabine|tenofovir 245 mg/emtricitabine 200mg
16053587|NCT02499874|Drug|tenofovir/lamivudine|tenofovir 245mg/lamivudine 300mg
16053588|NCT02499874|Drug|lamivudine/zidovudine|lamivudine 300mg/zidovudine 600mg
16053589|NCT02499861|Drug|Decitabine and Genistein|intravenous Decitabine with oral genistein
16053590|NCT02499848|Drug|PRX302|Single prostate cancer lesion injected with PRX302.
16053591|NCT02499835|Biological|Pembrolizumab|Given IV
16053592|NCT02499835|Biological|pTVG-HP Plasmid DNA Vaccine|Given ID
16053593|NCT02499822|Drug|Nifedipine GITS|Commercially available drug formulations are used. Study medication will be assumed in a single morning (7-10 a.m.) administration per os.
16053594|NCT02499822|Drug|Ramipril|Commercially available drug formulations are used. Study medication will be assumed in a single morning (7-10 a.m.) administration per os.
16053595|NCT02499809|Other|Recovery mode|After the gradual maximal exercise the subjects will use different recovery modes (vibration therapy or passive and active recovery).
16053596|NCT02499796|Device|Hygrovent Gold|
16053597|NCT02499796|Device|Heated and moisture exchanger (HME)|
16053598|NCT02499796|Device|Heated humidifier (HH)|
16053599|NCT02499783|Biological|adalimumab|subcutaneous injections of adalimumab
16053600|NCT02499783|Other|placebo|subcutaneous injections of placebo
16053601|NCT02499770|Drug|Carboplatin|
16053602|NCT02499770|Drug|Placebo|
16053603|NCT02499770|Drug|Trilaciclib|
16053604|NCT02499770|Drug|Etoposide|
16053605|NCT02499757|Device|flavor and sweetener|maltol added as sweetener to e-cigarette with flavor
16053606|NCT02499757|Device|flavor and nicotine|12 mg of nicotine added to e-cigarette with flavor
16053607|NCT02499757|Device|flavor, nicotine and sweetener|12 mg nicotine and maltol (sweetener) added to e-cigarette with flavor
16053608|NCT02499757|Device|flavor|flavored e-cigarette stand alone without added nicotine and maltol (sweetener)
16053609|NCT02499744|Device|NIPPV|"For infants in the NIPPV-group who failNIPPV (see definition below), need immediate intubation, a invasive Rescue-Treatment may be provided. The decision to attempt Rescue-Treatment, the mode of respiratory support and the ventilator settings used are at the discretion of the attending clinician."
16053610|NCT02499744|Device|HHFNC|"For infants in the HHFNC-group who failHHFNC (see definition below), need immediate intubation, a invasive Rescue-Treatment may be provided. The decision to attempt Rescue-Treatment, the mode of respiratory support and the ventilator settings used are at the discretion of the attending clinician."
16053611|NCT02499731|Behavioral|Strong Hearts, Healthy Communities|"We will evaluate the efficacy of the SHHC curriculum in a 24-week community-based randomized controlled intervention trial. We will compare changes in CVD-related anthropometric, physiologic, behavioral, and psychosocial parameters between subjects in 8 intervention and 8 control communities. In addition, we will evaluate changes in behavior, attitudes, and knowledge among SHHC intervention subjects' social network."
16053612|NCT02499731|Behavioral|Strong Hearts, Healthy Women|"The Strong Hearts, Healthy Women (minimal intervention) will meet once per month for an hour each time for 6 months.
~Participants will learn and discuss techniques and strategies to improve personal health."
16053613|NCT02499718|Device|BiPAP mode|Noninvasive ventilator
16053614|NCT02499705|Dietary Supplement|Sucralose|2 packets
16053615|NCT02499705|Dietary Supplement|Sucrose|equisweet to sucralose
16053616|NCT02499705|Dietary Supplement|Sucralose + maltodextrin|sucralose plus equicaloric (to sucrose) maltodextrin
16053617|NCT02499692|Device|SYNERGYTM Coronary Stent System|SYNERGYTM MONORAILTM Everolimus-Eluting Platinum Chromium Coronary Stent System
16053618|NCT02499666|Procedure|Percutaneous Coronary Intervention|As clinically indicated, patients will have a percutaneous balloon angioplasty and stent deployment of a chronic total occlusion (i.e., an artery that has a 100% blockage for several months).
16053619|NCT02499666|Device|Coronary stent|As clinically indicated, patients will have a coronary stent placement into their occluded coronary artery after successful balloon angioplasty
16053620|NCT02499666|Drug|Clopidogrel|As clinically indicated, patients who are not already on dual antiplatelet therapy will be started on a second agent such as clopidogrel.
16053621|NCT02499653|Behavioral|Psychological Intervention|
16053622|NCT02499653|Behavioral|Videos|
16053623|NCT02499640|Other|immersion cold water|immersion cold water at different temperatures and exposure times
16053624|NCT02499627|Drug|Brentuximab Vedotin|Brentuximab will be given intravenously at a total dose of 1.8 mg/kg on day 1 of each 21 days-based cycle, for 6 cycles.
16053625|NCT02499627|Drug|Bendamustine|Bendamustine will be administered at a dose of 90 mg/m2 on day 1 and 2 of each 21 days-based cycle, for 6 cycles.
16053626|NCT02499614|Drug|Crizotinib|Eligible patients with ROS1 translocation or MET amplification will be treated with Crizotinib at the standard dose of 250 mg BID. The dose of crizotinib may be adjusted depending on the type and severity of toxicity encountered
16053627|NCT02499601|Device|CORolla™ TAA device|
16053628|NCT02499588|Device|Esteem Plus with ConvaTec Moldable Technology|
16053629|NCT02499588|Device|Natura with ConvaTec Moldable Technology|
16053630|NCT02499588|Device|Natura Accordion with ConvaTec Moldable Technology|
16053631|NCT02499588|Device|Esteem synergy Plus with ConvaTec Moldable Technology|
16053632|NCT02499575|Drug|0.5% ropivacaine|Adductor block: 10 mL of 0.5% ropivacaine; popliteal block: 30 mL of 0.5% ropivacaine
16053633|NCT02499575|Drug|Exparel|106 mg (8 mL, equivalent to 120 mg bupivacaine HCl)
16053634|NCT02499562|Drug|Hydronidone|The investigational products in the test groups and control group shall be orally taken 30 minutes before meals for 52 continuous weeks. There are respectively 60 cases in the test group I, II, III and the control group, totally 240 cases.
16053635|NCT02499562|Drug|Placebo|
16053636|NCT02499562|Drug|Entecavir|
16053637|NCT02499549|Drug|cocamide diethanolamine|10% Cocamide DEA aqueous lotion is applied directly to dry hair and is washed off with water only
16053638|NCT02499536|Device|ultrasound|Juxtapleural consolidation, loss of A lines, presence of B lines, air bronchogram, loss of sliding sign and presence of pulse sign on lung ultrasound finding will be investigated and recorded.
16053639|NCT02499523|Procedure|THR with conventional technique|THR with conventional technique.
16053640|NCT02499523|Procedure|THR with Acetabular Cup Orientation Guides (ACOG)|THR with the ACOG System.
16053641|NCT02499510|Device|GoldenFlow Stent|The GoldenFlow stent (Lifetech Science, Shenzhen, China) is a TiN coated self-expanding stent consisting of interwoven nitinol wires braided in a closed cell design. Stents used in this study ranged from 4-12mm in diameter and 20-160mm in length.
16053642|NCT02499497|Drug|LY2452473|LY2452473 is a selective androgen receptor modulator which is agonist on the muscle but which spares the prostate.
16053643|NCT02499497|Drug|Placebo|The participants will receive pills containing no active drug.
16053644|NCT02499484|Drug|glyceryl trinitrate|Topical GTN will be used daily in combination with a eccentric home exercise program
16053645|NCT02499484|Other|Placebo ointment|Topical placebo ointment will be used in combination with a eccentric home exercise program
16053646|NCT02499484|Other|Eccentric exercise program|All participants will complete the eccentric exercise program as a home exercise program daily.
16053647|NCT02499471|Other|Levothyroxine therapy (137.75 ± 23.75 μg/day)|This study was a longitudinal study in an academic center, with a follow-up period of 6 months. Ten patients with well-differentiated thyroid carcinoma eligible for surgical treatment and subsequent radioactive iodine ablation therapy were studied in a hypothyroid state after thyroidectomy and in a subclinical hyperthyroid state (TSH-suppression according to standard treatment protocol).
16053648|NCT02499458|Other|None- observational study|
16053649|NCT02499445|Drug|Remifentanil|administering remifentanil for anesthesia maintenance
16053650|NCT02499445|Drug|sevoflurane 1|administering sevoflurane 1 for anesthesia maintenance
16053651|NCT02499445|Drug|sevoflurane 2|administering sevoflurane 2 for anesthesia maintenance
16053652|NCT02499445|Drug|propofol|administering propofol for anesthesia maintenance
16053653|NCT02499445|Drug|sufentanil|administering sufentanil for anesthesia maintenance
16053654|NCT02499432|Behavioral|Motivational Enhancement|Motivational Enhancement/Interviewing is a form of discussion that seeks to increase change behavior.
16053655|NCT02499406|Behavioral|Dialectical behavior therapy skills group|Skills training in emotion regulation, distress tolerance, interpersonal effectiveness, and mindfulness
16053656|NCT02499393|Drug|Magnesium Sulfate|intravenous infusion of magnesium sulphate
16053657|NCT02499380|Device|PneumRx Coil System|
16053658|NCT02499367|Drug|Nivolumab|nivolumab 3 mg/kg, every 2 weeks after induction treatment
16053659|NCT02499367|Radiation|Radiation therapy|20 Gy to metastatic lesion
16053660|NCT02499367|Drug|Low dose doxorubicin|15 mg flat dose, once weekly for 2 weeks
16053661|NCT02499367|Drug|Cyclophosphamide|metronomic schedule, 50 mg daily orally for 2 weeks
16053662|NCT02499367|Drug|Cisplatin|40 mg/m2, weekly for 2 weeks
16053663|NCT02499354|Drug|Ferumoxytol intravenous|IV iron, 2 vials of 510 mg given 2-7 days apart
16053664|NCT02499354|Drug|Ferrous sulfate|Oral iron, 325 mg tabs taken morning and evening
16053665|NCT02499341|Drug|Tramadol|Tramadol administered intravenously (1mg/kg) thirty minutes before the expected end of surgery, followed by a continuous infusion of tramadol (0.2mg•kg-¹•h-¹) for up to 48 h after major upper abdominal surgery, in patients receiving PCA morphine postoperatively at a bolus dose of 1 mg with a lockout period of 8 minutes.
16053666|NCT02499341|Drug|Ketamine|Ketamine administered intravenously (0.5mg/kg) thirty minutes before the expected end of surgery, followed by a continuous infusion of ketamine (0.12mg•kg-¹•h-¹) for up to 48 h after major upper abdominal surgery, in patients receiving PCA morphine postoperatively at a bolus dose of 1 mg with a lockout period of 8 minutes.
16053667|NCT02499328|Drug|AZD9150|AZD9150
16053668|NCT02499328|Drug|MEDI4736|MEDI4736
16053671|NCT02499315|Drug|AMG 357|Oral tablets in 20 count bottles. Dose strengths include 5, 25, and 50 mg tablets.
16053672|NCT02499315|Drug|Placebo|Oral tablets in 20 count bottles. Dose strengths include 5, 25, and 50 mg tablets.
16053673|NCT02499302|Behavioral|Mental training|
16053674|NCT02499276|Device|PSV, NAVA, PAV, Variable-PSV|Each patient enrolled in the study will be ventilated in all the following modes: PSV, NAVA, PAV and variable PSV
16053675|NCT02499250|Device|remote ischemic conditioning (TDFT-12-A2)|"The subjects will receive twice daily of 4×5min/5min ischemic/reperfusion of both arms (remote ischemic conditioning) over 30 days using the TDFT-12-A2 device produced by Shenzhen TDF Tai Smart technology Co., Ltd."
16053676|NCT02499250|Drug|Optimal medical treatment|The subjects will receive optimal medical treatment according up-to-date guidelines, including adequate antiplatelet therapy, statins, β-blocker and nitrates, plus angiotensin converting enzyme inhibitor(ACEI)/angiotensin receptor blocker(ARB),oral anticoagulants, if necessary.
16053677|NCT02499237|Drug|Denosumab|Treatment of low bone mass with subcutaneous injections of denosumab 60 mg every 6 months for one year
16053678|NCT02499237|Drug|Zoledronic acid|Treatment of low bone mass with a single infusion of zoledronic acid 5 mg for one year
16053679|NCT02499224|Drug|YYB101|"Dose-escalation cohort: YYB101 of each dose level (0.3mg/kg to 5mg/kg), IV infusion on Day 1, Day 29, and followed by every 2 weeks until disease progression or unacceptable toxicity development.
~Dose-expansion cohort: YYB101 of MTD (or RP2D), IV infusion every 2 weeks until disease progression or unacceptable toxicity development"
16053680|NCT02499211|Other|Intervention stores|"In-store marketing strategies will focus on placement and promotion of healthier items (lower calorie options) in the milk, frozen food, beverage checkout cooler, bread, salty snacks, and cheese sections of the store.
~Intervention efforts in the dairy section promote lower calorie milk (skim, 1%, and 2%), while diminishing the presence of whole milk. The visual order of the milk displays will be changed, and the number of facings, or the fronts of packages the consumer can see, of whole milk will be decreased by 30% while increasing the facings of the lower calorie milk. In the other product categories, target products will be moved to eye level and the number of facings will be increased.
~Call-out signs will be placed by the target products that list the name and price of the product. No health information or claims will be included. Signage will be rotated monthly to increase the chances that customers will notice them."
16053681|NCT02499185|Device|Nephro Check Test|Urine sample
16053682|NCT02499185|Other|serum creatinine measurement|Blood sample
16053683|NCT02499172|Biological|Shanchol|
16053684|NCT02499159|Drug|Liposomal Bupivicaine|266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle.
16053685|NCT02499159|Drug|0.25% standard bupivicaine|standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.
16053686|NCT02499146|Drug|Palbociclib|125 mg orally once daily with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle
16053687|NCT02499146|Drug|Letrozole|2.5 mg , orally once daily (continuously)
16053688|NCT02499133|Other|language and cognitive tests|The participants will undergo seven different. The tests will include different cognitive and language examinations. The main test of the study will be The Hebrew Focused Stress Test (HFST). The HFST includes three subtests. The first subtest requires identification of the stressed word in a sentence based on psychoacoustic abilities alone. The second and the third subtests require understanding the meaning of focused stress in different contexts - lexical grammatical and pragmatic/social. The test includes forty eight recorded sentences. In each sentence one word is stressed. The participants will be asked to listen to the recordings and answer a closed question regarding the stressed word.
16053689|NCT02499120|Drug|palbociclib|Palbociclib will be supplied as capsules containing 75 mg, 100 mg, or 125 mg equivalents of palbociclib free base. Administered with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle.
16053690|NCT02499120|Drug|Cetuximab|Cetuximab injection for IV infusion will be provided in 100 mg/50 mL, single-use vials, and 200 mg/100 mL, single-use vials. In Japan, cetuximab will be provided in 100 mg/20 mL, single-use vials. Administered, 400 mg/m2 initial dose as a 120-minute IV infusion followed by 250 mg/m2 weekly infused over 60 minutes.
16053691|NCT02499120|Drug|Placebo|"Placebo for palbociclib will be indistinguishable from the palbociclib capsules and will be supplied as capsules matching in size and color the various palbociclib formulations.
~Administered with food on Day 1 to Day 21 followed by 7 days off treatment in a 28-day cycle."
16053692|NCT02499107|Dietary Supplement|Rice treatment|All arms are given to all participants, in a randomized (cross over) order
16053693|NCT02499107|Dietary Supplement|Pasta treatment|
16053694|NCT02499107|Dietary Supplement|Boiled and mashed potato treatment|
16053695|NCT02499107|Dietary Supplement|Baked french fries treatment|
16053696|NCT02499107|Dietary Supplement|Fried french fries treatment|
16053697|NCT02499094|Other|Behavioral-data driven support|Phone-based support (e.g. triaging of the situation, emotional support, and guidance on next steps for the patient) and in-app support (health education content based on cognitive behavioral therapies, mindfulness, and behavioral activation)
16053698|NCT02499081|Drug|Ixazomib|
16053699|NCT02499068|Device|Telehealth|Monitoring devices installed at patients home and patients are monitored on a daily bases for early detection of exacerbations and prompt clinical intervention.and being follow-up on a daily bases for early detection and prompt intervention.
16053700|NCT02499055|Behavioral|FearFighter|FearFighter™ is a nine session cognitive behavioural self-help therapy program delivered over the internet during nine weeks. Each session on FearFighter excluding the homework takes about 30-40 minutes to finish. A support person will make a weekly contact of 10 minutes in average to secure understanding of the program and compliance.
16053701|NCT02499042|Drug|Oxygen|oxygen delivery by ETT/ SGA connected to bag/valve/oxygen reservoir
16053702|NCT02499029|Drug|N-acetylcysteine|NAC pills were administered each week. NAC is a N acetyl pro-drug of the naturally-occurring amino acid cystine. NAC is a white, crystalline powder with the molecular formula C5H9NO3S and with a molecular weight of 163.2.
16053703|NCT02499029|Drug|Placebo|Identical looking placebo pills were administered each week.
16053704|NCT02499016|Procedure|suprapubic single-incision laparoscopic appendectomy|the approach of appendectomy
16053705|NCT02499003|Drug|Obinutuzumab and Pixantrone|Obinutuzumab: 1000 mg flat dose on day 1, 8, 15 of cycle one and day 1 of subsequent cycles, Pixantrone: 50 mg/m² Pixantrone on day 1,8,15 of each 28 d cycle
16053706|NCT02498990|Behavioral|Low calorie diet followed by life style intervention|"Low calorie diet of 800 kcal/day for 7 weeks.
~Life style intervention for the remaining study period"
16053707|NCT02498977|Genetic|Biomarker|Real time polymerase chain reaction (PCR) gene expression measurement
16053708|NCT02498977|Drug|Tacrolimus, cyclosporine and/or mycophenolic acid, mycophenolate mofetil or azathioprine|Immunosuppression drugs as per protocol
16053710|NCT02498951|Procedure|Cognitive Assessment|Ancillary studies
16053711|NCT02498951|Biological|Obinutuzumab|Given IV
16053712|NCT02498951|Other|Quality-of-Life Assessment|Ancillary studies
16053713|NCT02498938|Genetic|SERPINA1 gene|2ml blood sample collected from patients to extract DNA for assessment of SERPINA1 gene polymorphism
16053714|NCT02498925|Behavioral|Behavioral Activation|Behavioral Activation is a psychosocial treatment for depression focused on gradually re-engaging patients with sources of reinforcement and reward in their environment (e.g., increasing activites and interpersonal interactions). In contrast to Cognitive Behavioral Therapy, and as the name implies, Behavioral Activation focuses on behavioral change strategies to improve mood and places little emphasis on cognitive restructuring techniques.
16053715|NCT02498912|Procedure|Production of Genetically-modified T cells|
16053716|NCT02498912|Drug|Cyclophosphamide|
16053717|NCT02498912|Device|IP Catheter Insertion|
16053718|NCT02498912|Genetic|Infusion of 4H11-28z/fIL-12/EGFRt+ Genetically-modified T cells|Patients who do not have sufficient CAR T cells for the assigned dose cohort will be treated in the cohort for which cells are available.
16053719|NCT02498912|Drug|Fludarabine|fludarabine dose 25-30 mg/m2 x 3 days
16053720|NCT02498899|Behavioral|Questionnaires|Participants complete questionnaires at baseline, after watching a video, and after reading a story about the patient in the video.
16053721|NCT02498899|Behavioral|Video|Participants watch a video lasting about 4 minutes.
16053722|NCT02498886|Dietary Supplement|IHAT|Iron hydroxide adipate tartrate (IHAT): Single dose capsule containing IHAT equivalent to 60mg iron with 2 mg isotopically enriched with 58Fe.
16053723|NCT02498886|Dietary Supplement|Ferrous sulphate|Ferrous sulphate: Single dose capsule containing ferrous sulphate heptahydrate equivalent to 60 mg iron with 10 mg isotopically enriched with 57Fe.
16053724|NCT02498873|Behavioral|Linear Periodization|Linear Intensity Periodization Running
16053725|NCT02498873|Behavioral|Non Linear Periodization|Non Linear Periodization Running
16053726|NCT02498860|Drug|Pemebit|500mg/m2 on day 1 of every 3-week cycle, for a maximum of 4 cycles
16053727|NCT02498860|Drug|Cisplatin|75mg/m2 on day 1 of every 3-week cycle, for a maximum of 4 cycles
16053728|NCT02498847|Behavioral|ENGAGE|"Participants are introduced to ENGAGE program by the study OT. The ENGAGE program is located on a website and has several modules. The modules include a video in which a health provider is featured. This health provider gives a short presentation on a topic related to OA, symptom management or lifestyle change. Within each module, there is downloadable homework and additional information which can be printed. The modules are:
~What is Osteoarthritis?
~Information about treatments
~Exercise
~Sleep hygiene
~Relaxation
~Pleasant Activity Scheduling
~Goal setting
~Problem Solving
~Pacing
~Communication"
16053729|NCT02498834|Behavioral|Educational Video and Question Prompt List|Educational Video and Question Prompt List
16053730|NCT02498821|Device|Chest X-ray|A Chest X-ray will be taken after healthcare providers have inserted the PICC to make sure it is in the correct location. The X-ray can tell your healthcare providers where the PICC is and whether is has been inserted correctly.
16053731|NCT02498821|Device|Sherlock 3CG® TCS|The Sherlock 3CG® TCS is a device that is placed on the subject during the PICC insertion procedure, which helps your healthcare providers know where the PICC is as the healthcare providers are inserting it. It uses magnets and measures electrical activity of the heart to determine the location of the catheter in your body.
16053732|NCT02498821|Procedure|Peripherally Inserted Central Catheter (PICC)|A peripherally inserted central catheter (PICC) is a form of intravenous access that can be used for a prolonged period of time (e.g., for chemotherapy, antibiotics, total parenteral nutrition)
16053733|NCT02498795|Other|Group of Dry Needling|Every group will receive a total of 4 treatment distributed throughout 8 weeks of treatment. The program of eccentric exercises that will have to realize it in his domicile every day.
16053734|NCT02498795|Other|Group of Electrolysis|Every group will receive a total of 4 treatment distributed throughout 8 weeks of treatment. The program of eccentric exercises that will have to realize it in his domicile every day.
16053735|NCT02498795|Other|Control Group|Every group will receive a total of 4 treatment distributed throughout 8 weeks of treatment. The program of eccentric exercises that will have to realize it in his domicile every day.
16053736|NCT02498782|Drug|Fexinidazole|
16053737|NCT02498782|Drug|Placebo|
16053738|NCT02498769|Drug|Botulinum Toxin Type A|The botulinum toxin will be injected into epicardial fat pads shortly after cardiopulmonary bypass is initiated.
16053739|NCT02498769|Drug|Placebo|
16053740|NCT02498756|Biological|Cytokine-induced killer cells|CIK cells are transferred every 3 months for 1 year.
16053741|NCT02498756|Drug|Ipilimumab|Ipilimumab are delivered every 3 weeks for one year
16053742|NCT02498743|Procedure|echocardiography|TV was connected to display the cartoon video during the echocardiography: the episode number 125 of 'Dora the Explorer': 'Baby Winky Goes Home!' was reproduced during the echocardiography.
16053743|NCT02498743|Behavioral|Watching Animated cartoons|
16053744|NCT02498730|Behavioral|Interval Training|High Intensity Interval Training at 100% VO2Max
16053745|NCT02498730|Behavioral|Continuous Training|Continuous Stimulous at 60% VO2Max
16053746|NCT02498730|Behavioral|Control|Only Dependent Variables Measures
16053747|NCT02498717|Device|GameReady|Cryotherapy and compression
16053748|NCT02498717|Other|RICE|SOC ice and elevation
16053749|NCT02498704|Procedure|Dry Needling|Trigger point dry needling to hamstring muscle group.
16053750|NCT02498704|Other|Sham Needling|Superficial palpation of trigger point, skin is not punctured.
16053751|NCT02498691|Biological|Biological collection|Blood and saliva samples, placenta and cord blood collection
16053753|NCT02498665|Drug|DSP-7888 Dosing Emulsion|"Dose escalation cohort: Patients will be administered escalating doses of DSP-7888 Dosing Emulsion intradermally or subcutaneously in accordance with the following regimen: once weekly for four weeks during the Induction Phase, once every 7 to 14 days for 6 weeks during the Consolidation Phase, and once every 14 to 28 days until a discontinuation criterion is met during the Maintenance Phase.
~MDS cohort 1: Patients will be intradermally administered of DSP-7888 at 10.5 mg every week for 4 weeks, every 2 weeks until Week 24, and then every 4 weeks.
~MDS cohort 2: Patients will be intradermally administered of DSP-7888 at 10.5 mg every 2 weeks until Week 24, and then every 4 weeks."
16053754|NCT02498652|Drug|RDEA3170 2.5 mg|"Cohort 1: RDEA3170 2.5 mg, 7.5 mg (2.5 mg × 3 tablets), and 15 mg (2.5 mg × 6 tablets).
~Cohort 2: RDEA3170 5 mg (2.5 mg × 2 tablets), 10 mg (2.5 mg × 4 tablets), and 20 mg (2.5 mg × 8 tablets)."
16053755|NCT02498652|Drug|allopurinol 300 mg|allopurinol 300 mg, allopurinol 600 mg (300 mg x 2 tablets)
16053756|NCT02498639|Procedure|percutaneous balloon aortic valvuloplasty|"Percutaneous BAV is performed according to the standard retrograde technique. The measurement of the trans-aortic gradient is given by two catheters placed one in the left ventricle, the other in ascending aorta. An extra stiff wire is placed in the left ventricular cavity. A balloon (size fitting the valve annulus) is inserted over the wire and a series of three inflations is performed at nominal pressure.
~The procedure terminates in case of:
~Reduction of the mean aortic gradient ≥50%.
~Aortic pressure drop during the inflations, indicative of valve orifice sealing.
~Intraprocedural complication.
~Poor compliance of the patient. If none is met, the balloon is changed with a bigger one and a new series of three inflations performed. Aortic gradient is finally recorded."
16053757|NCT02498626|Other|venous saturations|Samples of venous saturations from the central venous line (CVP), from venous side of the heart lung machine and from the pulmonary artery were taken at 10 min after being on CPB and after correction of the cardiac defects.
16053763|NCT02498600|Biological|Ipilimumab|Given IV
16053764|NCT02498600|Biological|Nivolumab|Given IV
16053765|NCT02498574|Device|Transcranial Direct Current Stimulation|Non-invasive brain stimulation applied to the surface of the scalp
16053766|NCT02498574|Behavioral|Working Memory Training|Cognitively challenging game played concurrently with transcranial direct-current stimulation
16053767|NCT02498561|Procedure|nonsurgical periodontal therapy|Scaling and root planning under local anaesthesia, in a total of four clinical visits Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush.
16053768|NCT02498561|Procedure|oral hygiene instructions|Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush
16053769|NCT02498561|Procedure|nonsurgical periodontal therapy|Scaling and root planning under local anaesthesia, in a total of four clinical visits Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush.
16053770|NCT02498561|Procedure|oral hygiene instructions|Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush
16053771|NCT02498548|Behavioral|Trained SCI Knee or Trained SCI Hip|Individuals with SCI will perform downhill walking training 3 times a week for 12 wks with a 4 wk follow-up period. This intervention will be delivered by trained therapists. In order to focus on rehabilitation of knee control or hip control, members of this group will be trained at slow to moderate gait speeds.
16053772|NCT02498535|Drug|Nitric Oxide 160 ppm|Nitric Oxide 160 ppm
16053773|NCT02498522|Drug|Metformin|83 patients will continue metformin until end of 1st trimester
16053774|NCT02498509|Drug|CKD-342|treatment for 4 weeks after randomization
16053775|NCT02498509|Drug|Mometasone furoate|treatment for 4 weeks after randomization
16053776|NCT02498509|Drug|Levocabastine HCL|treatment for 4 weeks after randomization
16053777|NCT02498496|Drug|Magnesium Sulfate|Administration of a bolus of 2 g of MgSO4 in 20 min, one dose.
16053778|NCT02498496|Drug|Placebo|Administration of 100 mL of Normal Saline
16053779|NCT02498483|Drug|Acetaminophen|Infants will receive 15 mg/kg of acetaminophen.
16053780|NCT02498470|Procedure|percutaneous coronary intervention|All the patients receiving coronal artery angiography or percutaneous coronary intervention therapy by standard protocol
16053781|NCT02498457|Other|low calcium dialysis|patients in this group will receive low calcium dialysis for 1 year.
16053782|NCT02498444|Drug|Treprostinil|Administration of drug (treprostinil) vs placebo (saline) in the post-operative period
16053783|NCT02498431|Procedure|percutaneous coronary intervention|a non-surgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease
16053784|NCT02498431|Procedure|coronary angiography|is a procedure performed along with cardiac catheterization that uses X-ray imaging to see your heart's blood vessels
16053785|NCT02498431|Device|Stent, Medronic Resolute Integrity|A stent is placed in an artery as part of a procedure called percutaneous coronary intervention (PCI) to restore blood flow through narrow or blocked arteries. A stent helps support the inner wall of the artery in the months or years after PCI.
16053786|NCT02498418|Drug|Rifaximin|Tablets, generic formulation of the brand product.
16053787|NCT02498418|Drug|Xifaxan®|Tablets, brand product.
16053788|NCT02498418|Drug|Placebo Tablet|Placebo tablets in the same image of the generic rifaximin. Has no active ingredient.
16053789|NCT02498392|Drug|JNJ-42165279|JNJ-42165279 will be administered orally at a dose of 25 milligrams (mg) tablet once daily for 6 weeks.
16053790|NCT02498392|Other|Placebo|Matching Placebo will be administered orally.
16053791|NCT02498379|Drug|Cu[64]-25%CANF-Comb|Intravenous injection of 4-8 mCi of Cu[64]-25%CANF-Comb with PET-CT scans performed 1-4 hours, 5-10 hours, and 22-26 hours or 46-50 hours after injection.
16054033|NCT02496728|Behavioral|Environmental Cues|Text messages, informational posts and reminders supporting healthy behaviors.
16053792|NCT02498366|Other|physical tests|"each subject will undergo the following physical tests: day 1 - anthropometric measurements, wingate test and after 1 hour rest VO2max test. lactic acid levels will be measured before and after both tests.
~day 2 - step test day 3 - running on the anaerobic threshold. blood sample, lactic acid level (measured in blood drop - finger sting) and urine sample will be taken before and after every test in days 2 and 3."
16053793|NCT02498353|Radiation|preoperative short-course radiotherapy with local boost|Except the clinical target volume(CTV),a gross tumour volume（GTV）is delineated，and give a dose of PTV-GTV:30Gy/5F
16053794|NCT02498353|Radiation|preoperative short-course radiotherapy without local boost|Preoperative short-course radiotherapy without local boost,the dose of radiotherapy is PTV-CTV 25Gy/5F
16053795|NCT02498353|Procedure|TME surgery|both study group and control group received surgery under TME principle after radiotherapy
16053796|NCT02498340|Dietary Supplement|non- fava beans|Patients will be subjected to eat non- fava beans diet at doses of 10 -30 gm (small to moderate amount) of 3 different types of non- fava beans, each one will be given once daily for 3 days.
16053797|NCT02498327|Other|Gelatine Capsule|Gelatine capsules containing only the inactive ingredients of starch amyral white, di-calcium phosphate DC and magnesium stearate fine.
16053798|NCT02498327|Other|Venavine Intensive®|Gelatine capsules containing 360 mg Red Vine Leaf extract, 60 mg of Horse Chestnut extract, 35 mg of Butchers Broom extract and 3,2 mg of Vitamin B6 as well as the inactive ingredients of starch amyral white, di-calcium phosphate DC and magnesium stearate fine.
16053799|NCT02498314|Other|Grade I-II SZ mobilization|Hip grade I-IISZ traction in a resting position is applied using gentle repetitive traction movements during 10 minutes. The mean peak force applied is 2,71N (S.D= 0,94), according to previous study. Peak forces were measured using dynamometer and the therapist used it as a feedback to ensure mean peak force levels remain consistent.
16053800|NCT02498314|Other|Grade II TZ mobilization|Hip grade IITZ traction in a resting position is applied during 10 minutes. The traction force is applied during 45 seconds with 15 seconds rest, until complete the 10 minutes of treatment. The mean peak force applied is 5.94 N (S.D= 1), according to previous study. Peak forces were measured using dynamometer and the therapist used it as a feedback to ensure mean peak force levels remain consistent.
16053801|NCT02498314|Other|Grade III mobilization|Hip grade III traction in a resting position is applied during 10 minutes. The traction force is applied during 30 seconds with 30 seconds rest, until complete the 10 minutes of treatment. The mean peak force applied is 7.04 N (S.D= 0.32), according to previous study. Peak forces were measured using dynamometer and the therapist used it as a feedback to ensure mean peak force levels remain consistent.
16053802|NCT02498301|Drug|Rifaximin|Rifaximin will be provided to subjects either daily with placebo, or twice daily depending on which of the two experimental arms they are randomized to
16053803|NCT02498301|Drug|Placebo|Placebo will be administered twice daily or once daily with rifaximin depending on which experimental arm they are randomized to
16053804|NCT02498288|Drug|Isotretinoin: Reference Medication 1|Isotretinoin reference medication 1 will be 40 mg in the pharmaceutical form of capsule (2 capsules of 20 mg each)
16053805|NCT02498288|Drug|Isotretinoin: Reference Medication 2|Isotretinoin reference medication 2 will be 40 mg in the pharmaceutical form of capsule (2 capsules of 20 mg each)
16053806|NCT02498288|Drug|Isotretinoin: Test Medication|Isotretinoin test medication will contain isotretinoin 40 mg (2 capsules of 20 mg each) in the same type of pharmaceutical presentation, containing the same drug but possible to have a different excipients.
16053807|NCT02498262|Other|Virtual Reality System|The participants will use a virtual reality system that is like a large video game and complete some job skill tasks in the virtual world video game.
16053808|NCT02498249|Device|low level laser therapy|Will be performed irradiation with low-intensity laser in upper trapezius muscle
16053809|NCT02498249|Device|Placebo low level laser therapy|Will be not performed irradiation with low-intensity laser in upper trapezius muscle
16053810|NCT02498236|Drug|Intranasal Oxytocin|
16053811|NCT02498223|Other|experiment protocol|"the subjects will undergo the following experiment protocol:
~recruitment and medical examination day.
~physiological evaluation day- the subjects will perform twice* a physiological stress protocol ; 3 min sitting followed by 20 min walking on treadmill (4 km/h, 4% slope), and then 3 min sitting for recovery examination. total 26 min.
~biomechanical valuation day- the subjects will perform twice* a biomechanical protocol using the Zebris system; 2 min standing followed by 10 min walking on treadmill (4 km/h, 4% slope). total 12 min.
~once carrying the weight calculated according to the army current instructions, and a second time carrying weight calculated according to the new LCI. 2 hours rest between the two performances."
16053812|NCT02498210|Other|In Vitro Maturation Procedure|POR patients will be treated in IVM cycle. After baseline evaluation on day 3, 150 IU/day recombinant FSH or HMG will be added for 3 days. A second evaluation will be performed on day 6 of the menstrual cycle. An injection of 10,000 IU hCG (Pregnyl; Organon, Oss, Holland) or Ovitrelle 250mcg (Merck Serono ) will be administered subcutaneously when the endometrial thickness will be ≥6 mm and the leading follicle will be at least 12 mm. Oocyte retrieval will be performed under ultrasound guidance with a 19G single-lumen aspiration needle (Cook; Queensland, Australia). The follicular fluid will be collected in culture tubes containing follicle flush buffer (Cook) with 2 IU/ml heparin. All aspirates were filtered to identify additional oocytes
16053813|NCT02498197|Behavioral|Participatory Intervention|
16053814|NCT02498197|Behavioral|Control|
16053815|NCT02498184|Other|acupuncture|
16053816|NCT02498171|Drug|Intrathecal morphine with fentanyl|"Parturients in this arm underwent a single shot spinal following standard procedure. the drug mixture was then introduced into the subarachnoid space following free flow of csf. the parturient was the monitored fo labour progression using the standard partogram, vital signs and the visual analogue scale score for pain recorded every 5 min.
~The fetus was monitored with an ultrasonic aided fetal Doppler until delivery"
16053817|NCT02498171|Drug|Intrathecal morphine with bupivacaine|"Parturients in this arm underwent a single shot spinal following standard procedure. the drug mixture was then introduced into the subarachnoid space following free flow of csf. the parturient was the monitored fo labour progression using the standard partogram, vital signs and the visual analogue scale score for pain recorded every 5 min.
~The fetus was monitored with an ultrasonic aided fetal Doppler until delivery"
16054034|NCT02496728|Behavioral|Social Support|Participants may interact with each other through a private Facebook group.
16053818|NCT02498158|Device|MRI scans|"20 subject (10 tolerant and 10 intolerant to heat) will undergo MRI scans (GE healthcare manufacturer) as follows:
~anatomical scan according to standard protocol
~functional scan according to the standard protocol of rest-state fMRI.
~scans of 10 healthy subjects will be taken from existing scans at the imaging department."
16053819|NCT02498145|Other|Nicotine e-cigarette|Patients will receive nicotine patch and intensive counseling plus e-cigarette with nicotine.
16053820|NCT02498145|Other|Non-nicotine e-cigarette|Patients will receive nicotine patch and intensive counseling plus e-cigarette without nicotine.
16053821|NCT02498132|Other|Behavioral Activation|BA is based in behavioral principles of depression that suggest that depression is caused by a lack of reinforcement in the environment for positive, non-depressed behaviors. As such, the goal of BA is to help the patient reengage in positive, non-depressed activities. In clinical trials, BA as a treatment component has been consistently superior to no treatment and treatment as usual control groups, and a large body of research has found that BA is either equally or more effective than CBT, CT, and antidepressant medications (Cuijpers, Van Straten, & Warmerdam, 2007; Dimidjian et al., 2006; Jacobson et al., 1996).
16053822|NCT02498132|Other|Cognitvie Based Therapy|CBT explores patterns of thinking that lead to self-destructive actions and the beliefs that direct these thoughts, people with mental illness can modify their patterns of thinking to improve coping
16053823|NCT02498132|Other|Treatment as Usual|Individuals will be provided with one on one therapy sessions
16053824|NCT02498106|Dietary Supplement|Orthica Soft Multi Mini and Orthica Fish EPA Mini|daily intake of 2 Orthica Soft Multi Mini capsules (containing vitamins [B1, B2, B3, B5, B6, B11, B12, C, D, E, Beta Carotene] and minerals [Iodine, Copper, Selenium, Iron, Zinc, Chrome, Manganese]) and 1 Orthica Fish EPA Mini capsule (containing n-3FA: eicosapentaenic acid [EPA] and docosahexaenic acid [DHA])
16053825|NCT02498093|Behavioral|Maximal strength training|
16053826|NCT02498093|Behavioral|conventional rehabilitation|
16053827|NCT02498080|Procedure|DEB PTA|paclitaxel drug eluting balloon PTA
16053828|NCT02498080|Procedure|Standard PTA|Standard PTA
16053829|NCT02498067|Behavioral|rPlan dual protection waiting room app intervention|
16053830|NCT02498054|Behavioral|Education with new meter feature.|The blood glucose meter has default settings for the colour range indicator which can be customized by the subjects and/or their healthcare professional. This colour range indicator will be presented to the subjects as a computer simulation to show subjects a range of typical blood glucose values and how this new feature would classify these results as being low (blue), in-range (green) or high (red).
16053831|NCT02498041|Procedure|Transnasal Endoscopy|Experimental procedure with transnasal endoscopy for the first 80% of the patients (n=90). The examination is limited to the esophagus and the proximal stomach.
16053832|NCT02498041|Device|Office-based disposable transnasal endoscopy Endosheath|Experimental procedure with portable, disposable transnasal endoscopy for the last 20% of patients only (n=25). The examination is limited to the esophagus and the proximal stomach.
16053833|NCT02498041|Device|Standard upper GI endoscopy|Upper GI endoscopy with standard gastroscope.
16053834|NCT02498041|Procedure|Esophageal biopsies|2 research biopsies taken if endoscopic evidence of columnar-lined esophagus
16053835|NCT02498028|Procedure|Cervical Fusion|Cervical Fusion is performed with a titanium cage (Company Peter Brehm, Weisendorf, Germany) and a plating system (Company Aesculap, ABC plating system, Tuttlingen, Germany)
16053836|NCT02498028|Procedure|Cervical disc Prostheses|The total disc replacement is performed with eiter a Freedom® Cervical Disc, AxioMed Spine Corporation, Garfield Heights, Ohio, USA or Active® C, Company, Aesculap, Tuttlingen, Germany
16053837|NCT02498015|Drug|"3D regimen"|"The 3D regimen contain paritaprevir/ritonavir/ombitasvir (75/50/12.5mg) once daily, dasabuvir 250mg twice daily for genotype 1b without cirrhosis."
16053838|NCT02498015|Drug|"3D regimen with ribavirin"|"The 3D regimen with ribavirin contain paritaprevir/ritonavir/ombitasvir (75/50/12.5mg) once daily, dasabuvir 250mg twice daily, and ribavirin (1000 mg regardless of weight) daily in two divided doses for genotype 1a and genotype 1b with cirrhosis."
16053839|NCT02498002|Device|Physical Activity Monitoring (Actiheart)|Monitor physical activity using an Actiheart monitor during the required periods.
16053840|NCT02498002|Other|Energy Intake Monitoring|Monitor energy intake by weighing and recording all foods/drinks consumed during the required periods.
16053841|NCT02498002|Other|Body Weight Monitoring|Monitor body weight during monitoring phase to ensure stability despite other monitoring activities.
16053842|NCT02498002|Procedure|Intravenous Cannulation|Fitting of an intravenous cannula to a vein on the forearm for blood sampling during laboratory protocols.
16053843|NCT02498002|Procedure|Adipose Tissue Biopsy|This is an optional feature which if included involves the removal of a 0.5 gram sample of adipose tissue from just below the skin using a needle.
16053844|NCT02498002|Drug|Lidocaine Hydrochloride|The anaesthetic that will be used to numb the site of the adipose tissue biopsy in the event it is included.
16053845|NCT02498002|Other|Post-Prandial Meal Tests|Consume two successive meals with regular blood samples throughout the ensuing hours (2-3 hours each).
16053846|NCT02498002|Radiation|DEXA Scan|Undergo a dual energy x-ray absorptiometry scan to examine body composition.
16053847|NCT02498002|Other|Actiheart Calibration|Submaximal treadmill test to calibrate monitoring equipment.
16053848|NCT02498002|Other|Daily Calorie Restriction|Reduce energy intake by 25% on a daily basis.
16053849|NCT02498002|Other|Intermittent Fasting with Weight Loss|Alternate between 24 hour cycles of fasting and feeding with 150% of normal intake when feeding.
16053850|NCT02498002|Other|Intermittent Fasting without Weight Loss|Alternate between 24 hour cycles of fasting and feeding with 200% of normal intake when feeding.
16053851|NCT02497989|Other|Inter-personal Communication (IPC)|RAs will meet older men in their households, and : i) approach the person(s), introduce self, develop rapport and request for time to discuss briefly about VMMC; ii) strike a conversation on reasons why they or their peers have not gone to be circumcised as well as reasons that would make them get circumcised, jotting down responses to guide the discussion; iii) using the 'VMMC Demand Creation Toolkit', discuss each reported barrier/facilitator carefully and completely, always ensuring the person(s) is/are engaged in the discussion (the goal is to pass correct and complete information in a relaxed and conversational manner); iv) revisiting each stated barrier/barrier and exploring what they now think about them after the discussion, and address any new or lingering concerns.
16053852|NCT02497989|Other|Dedicated Service Outlets (DSO)|RAs shall visit every household with eligible men to inform them about the availability of DSO sites in their neighborhoods. After describing the characteristics of DSO sites, the RA will share - both verbally and through a flyer, information on where to find DSO sites in the respective Location. RAs will respond to questions using 'All You Need to Know About VMMC' booklet, the same way current recruiters do. They will also inform potential participants that all other VMMC sites continue to serve all men regardless of age (i.e., including older men) while DSO sites will only serve men aged ≥25 years.
16053853|NCT02497976|Biological|Certolizumab pegol|400 mg
16053854|NCT02497976|Drug|Placebo|Normal saline
16053855|NCT02497963|Procedure|Foreskin Graft-Tubularized Incised Plate|TIP Urethroplasty with foreskin graft in primary hypospadias
16053856|NCT02497963|Procedure|Tubularized Incised Plate|TIP Urethroplasty without foreskin graft in primary hypospadias
16053857|NCT02497950|Device|HeartMate 3|Any patient that is determined to meet the HM3 commercially approved labelling indication and that is implanted with the HM3
16053858|NCT02497937|Drug|GSK2798745|GSK2798745 will be supplied as granule filled capsule with unit dose strength of 2.4 mg to be administered orally with 240 mL water.
16053859|NCT02497937|Drug|Placebo|Placebo will be supplied as blend filled capsule to be administered orally with 240 mL water.
16053860|NCT02497924|Drug|GBT440|GBT440 capsules followed by single dose of [C14] GBT440 oral suspension
16053861|NCT02497911|Procedure|Adductor Canal Catheter|0.5% Ropivicaine for primary block and 0.2% Ropivicaine infusion by OnQ Pump
16053862|NCT02497911|Procedure|Intraarticular Catheter|0.5% Bupivicaine for primary block and 0.125% Bupivicaine infusion by OnQ Pump
16053863|NCT02497911|Drug|Ropivicaine|
16053864|NCT02497911|Drug|Bupivicaine|
16053865|NCT02497898|Biological|Cytokine-induced killer cells (CIK)|Cytokine-induced killer (CIK) cells are able to eradicate lymphomas and other malignancies. CIK cells are generated by incubation of peripheral blood lymphocytes with an anti-cluster of differentiation 3 (anti-CD3) monoclonal antibody, interleukin-2 (IL-2), interleukin-1 (IL-1) and interferon-gamma.
16053866|NCT02497872|Procedure|Biliary stone removal|Biliary stones are removed from the common bile duct by means of a sphincterotomy performed by standardized endoscopic retrograde cholangiopancreatography
16053867|NCT02497859|Behavioral|Egg Breakfast (EB)|The EB will receive a breakfast of higher quality protein, but similar in macronutrient and energy density than the active comparator. The EB will have the following energy density, macronutrient composition, and protein score: weight 291 g,energy 400 kcal, energy density 1.37 kcal/g, carbohydrate 42.9%, fat 35.5%, protein 19.8%, protein digestibility corrected amino acid score (PDCAAS) 100, leucine 1.77 g, glycemic load 24, fiber 1.0 g.
16053868|NCT02497859|Behavioral|Cereal Breakfast (CB)|The CB will receive a breakfast of lower quality protein, but similar in macronutrient and energy density than the experimental treatment. The CB will have the following energy density, macronutrient composition, and protein score: weight 293 g, energy 398 kcal, energy density 1.3 kcal/g, carbohydrate 44.8%, fat 35.4%, protein 19.8%, protein digestibility corrected amino acid score (PDCAAS) 42, leucine 0.48 g, glycemic load 30.8, fiber 4.4 g.
16053869|NCT02497859|Behavioral|Weight Loss Counseling|Weight loss counseling will be administered by a Registered Dietitian and will utilize information and materials derived from the Evidence Analysis Library (EAL) of the Academy of Nutrition and Dietetics (AND). Topics including portion control, macronutrient distribution, snacking, eating out, cooking and grocery shopping, will be discussed. Self-monitoring, motivational interviewing, goal setting, and problem solving will be the behavioral strategies used during counseling.
16053870|NCT02497859|Behavioral|Weight Loss Diet|Energy intake for study duration will be prescribed at 1,200-1,500 kcals adjusted for each individual's body weight.
16053871|NCT02497846|Device|TEOSYAL® PureSense Redensity [I]/MicronJet®|According the instruction of use, 3 injections of TEOSYAL® PureSense Redensity [I]will be performed all the 3 weeks. The used needle will be the MicronJet® microneedles for product injection. And the last visit (of control) will be performed 3 weeks after the last injection.
16053872|NCT02497833|Dietary Supplement|retinoic acid|During the trial period, the participants are instructed to consume retinoic acid capsules twice daily (30 min after breakfast and supper).The retinoic acid capsules provided a total daily intake of 10 mg of retinoic acid.
16053873|NCT02497833|Other|placebo|During the trial period, the participants are instructed to consume placebo capsules twice daily (30 min after breakfast and supper).The placebo capsules are composed of starch and pigment.
16053874|NCT02497820|Drug|Aspirin|"Aspirin (acetylsalicylic acid) has a marketing approval for use in the EU and is widely available as an over the counter medicine. However it is not being used within its licensed indication and the aspirin (at any dose in this study) will be treated as an investigational medicinal product (IMP).
~Tablets will be provided as enteric-coated 100mg or 300mg tablets for oral use. All patients will receive at least some dose of aspirin but blinding to the actual dose will be achieved by the use of 'dummy' tablets using the same excipients as in the active formulation of the aspirin minus the active ingredient.
~The aspirin and dummy tablets should be stored at room temperature below 25⁰C in a dry place."
16053875|NCT02497794|Other|chew gum|The patients in the study group,will chew one sugarless gum for 30 minutes in postoperative 3., 5. and 7. hours. The control group will be followed without chew gum. Both patient groups will be mobilized in postoperative 6 hour and 8 hour after the operation, juicy food will be given. It will be introduced to solid foods after bowel movements and gas output occurs. All patients postoperatively 4, 6,8,10., 12., 24 and 48 hours will be examined and bowel sounds will be oscult. Gas evolution is still not, enema will be applied. All patients will note the time of first rumbling of the stomach, first feeling of hunger and the first gas outlet.
16053876|NCT02497781|Drug|Ceftazidime -avibactam|Patients randomised (3:1) to the CAZ-AVI or cefepime treatment
16053877|NCT02497781|Drug|Cefepime|Patients randomised (3:1) to the CAZ-AVI or cefepime treatment
16053878|NCT02497768|Other|Chewing of nuts|The volunteers will be asked to chew and spit 8 portions (4-5 g) of nuts (pistachios or Brazils) on two separate visits. They will provide samples for particle sizing. Two portions will be used as practice samples in order to measure the number of chews. Two portions will be sieved. Two portions will be measured by laser diffraction. Two portions will be frozen for later lipid analysis.
16054031|NCT02496741|Drug|Metformin and chloroquine combination|Metformin and chloroquine are two oral medications. Metformin is to be taken twice daily, chloroquine once daily.
16053879|NCT02497755|Behavioral|App for smartphone|A smartphone app will send psychoeducation and reminders to patients to complete self-report data, will collect passive data, and will provide aggregated information to a provider dashboard.
16053880|NCT02497755|Device|smartphone|
16053881|NCT02497742|Other|Basic metabolic panel|Patients blood is collected in routine fashion for basic blood chemistries
16053882|NCT02497729|Procedure|Written Checklist|Use of a written checklist pre and peri-intubation
16053883|NCT02497729|Procedure|Head of Bed Up|Raising the patient's head of bed to 25 degrees
16053884|NCT02497716|Drug|Rivaroxaban (Xarelto, BAY59-7939|Single dose of reconstituted rivaroxaban granules
16053885|NCT02497703|Device|Knee robot|
16053886|NCT02497690|Behavioral|Telemedicine|Half of subjects will undergo six months of ART administered via telehealth. Therapy will be provided in the usual manner, except a computer will be used to facilitate the interaction.
16053887|NCT02497690|Behavioral|In-person ART|Half of subjects will undergo six months of ART administered in person. Therapy will be provided in the usual manner.
16053888|NCT02497677|Behavioral|Circle of Security -Parenting|The COS-P manual and video material has been translated to Danish (Tryghedscirklen - Forældreprogrammet, manual, Lier, 2013). Based on standard video material of parent-infant interactions, parents are trained to see and understand infant attachment behavior and especially to learn about infant miscuing attachment signals. In the current study parents will attend 10 sessions of 1.5 hour duration
16053889|NCT02497677|Behavioral|Care as Usual|CAU are different in the three participating districts and vary in content and duration. All three districts offer (a) group interventions for mothers who experience postnatal depressive symptoms and/or (b) extra counselling home-visits by a health nurse. Number and content of extra home-visits vary in accordance with the families' specific needs, and will rarely exceed 12 extra visits per year.
16053890|NCT02497664|Other|Active Breathing Control|
16053891|NCT02497651|Dietary Supplement|Liquid mixed meal|The subjects will ingest a 400 ml chocolate drink, rich on carbohydrates, fat and lipids. In the following 4 hours, blood samples will be drawn from a PVC for the measurement of plasma glucose, gut- and pancreatic hormones, acetaminophen etc. After the 4 hours, the subjects will be offered an ad libitum meal.
16053892|NCT02497651|Other|Skin Biopsy|All subjects will undergo a skin biopsy procedure. Two small (3 mm) biopsies will be taken from the hip area under local anaesthesia. Standard wound treatment will follow.
16053893|NCT02497638|Drug|Metformin|One month run-in of 850 mg metformin once daily, followed by 850 mg twice daily of metformin until progression.
16053894|NCT02497638|Drug|Atorvastatin|Atorvastatin 20 mg once daily until progression.
16053895|NCT02497638|Drug|Placebo (corresponding to metformin)|One month of one placebo tablet (corresponding to metformin) once daily, followed by one placebo tablet twice daily until progression.
16053896|NCT02497638|Drug|Placebo (corresponding to atorvastatin)|One placebo tablet (corresponding to atorvastatin) once daily until progression.
16053897|NCT02497625|Behavioral|Positive Therapeutic Alliance|Intervention involving reassurance and information related to the return to daily activities, advice on dealing with the pain and clear explanation of signs and symptoms. The session will take 60 minutes and will be structured to increase the therapeutic alliance and empathy. Patients will be instructed to return in a week for further consultation to clarify doubts.
16053898|NCT02497625|Behavioral|Usual care|Information about low back pain based on Back Book. The therapy will be performed with limited interaction between patient and therapist and the information will be transmitted in a clear and direct way. The limited interaction between patient and therapist in this group will be established at the first session lasting 45-60 minutes. Patients will be instructed to return for a visit after a week to clarify questions.
16053899|NCT02497625|Other|Control group|Patients will not receive intervention in the first month in which they are enrolled. After a year, the treatment offered to the Positive Therapeutic Alliance or Usual Care group will be available for patients who are interested.
16053900|NCT02497612|Drug|Ferroquine SSR97193|Pharmaceutical form:Capsules Route of administration: oral
16053901|NCT02497612|Drug|Artefenomel|Pharmaceutical form:Granules for suspension Route of administration: oral
16053902|NCT02497612|Other|Placebo|Capsules. Placebo capsules were used to keep the same number of capsules in each weight band while keeping the ferroquine dose blinded. No participant received placebo only.
16053903|NCT02497599|Drug|Indium-111-DOTA-Girentuximab-IRDye800CW|Indium-111-DOTA-Girentuximab-IRDye800CW tracer injection will be administered 7 days before (partial) nephrectomy
16053904|NCT02497599|Radiation|SPECT/CT|4 or 5 days after tracer injection a SPECT/CT of the abdomen will be acquired.
16053905|NCT02497599|Procedure|Intraoperative dual-modality imaging|7 days after dual-labeled girentuximab injection standard of care surgery will be performed extended with the use of dual-modality imaging.
16053906|NCT02497586|Radiation|Magnetic resonance spectroscopy|Magnetic resonance spectroscopy (MRS) is a type of scan which offers the possibility of assessing tumour function by measuring concentrations of chemicals (metabolites) within the abnormal tissue. It is a well-established technique in imaging brain cancers.
16053907|NCT02497573|Other|Diffuse Weighted MRI|The DW MRI scans will be used to measure ADC and to calculate change in ADC between the 2 scans. Each scan will take approximately 30 minutes. Images will be acquired and analysed as per the separate scanning protocol.
16053908|NCT02497560|Dietary Supplement|proprietary formula|
16053909|NCT02497547|Drug|Oxytocin|
16053910|NCT02497547|Drug|Placebo|
16053911|NCT02497508|Drug|nivolumab|
16053912|NCT02497495|Other|immersion cold water|immersion cold water at different temperatures and exposure times
16053913|NCT02497469|Drug|Vedolizumab|Vedolizumab infusion
16053914|NCT02497469|Drug|Adalimumab placebo|Adalimumab placebo-matching injection
16053915|NCT02497469|Drug|Adalimumab|Adalimumab injection
16053916|NCT02497469|Drug|Vedolizumab placebo|Vedolizumab placebo-matching infusion
16053917|NCT02497456|Behavioral|Follow-up counselling|
16053947|NCT02497274|Other|taste assessment and epithelium gustatory smear and biopsy|assessment of taste perceptions and expression of taste receptors before and after bariatric surgery and epithelium gustatory smear and biopsy
16054032|NCT02496728|Behavioral|Mobile Health Application|An application on a smart phone that is designed to help individuals self-monitor health behaviors.
16053918|NCT02497443|Biological|Autologous mesenchymal stem cells|Autologous bone marrow-derived mesenchymal stem cells, expanded ex vivo and neuroinduced (a portion of the cells). The final autologous cultured MSCs (0.7 -1.4 x 106 cells/kg of weigh) and autologous neuroinduced MSCs (0.04 - 0.1 x 106 cells/kg of weigh) were used for intravenous administration (cultured MSCs) and a subsequent endolumbal injection (neuroinduced MSCs) one week later in the patients in an autologous manner.
16053919|NCT02497404|Drug|5-Azacytidine|"Patients will be given a five day course of subcutaneous 5-azacytidine followed by a reduced intensity conditioning regimen of fludarabine and melphalan with or without total body irradiation prior to an allogeneic hematopoietic stem cell transplantation from a related or unrelated HLA matched donor. 5-Azacytidine 75 mg/m2 subcutaneously daily at the same time on days -11, -10, -9,
~-8 and -7. This will be administered on an outpatient basis if possible."
16053920|NCT02497404|Drug|Fludarabine|Conditioning regimen: Hospital admission will usually take place on the first day of the conditioning regimen. Fludarabine will be given at 40 mg/m2 intravenously daily at the same time over 30 minutes on days -6,-5,-4,-3.
16053921|NCT02497404|Drug|Melphalan|Conditioning regimen: Hospital admission will usually take place on the first day of the conditioning regimen. Melphalan will be given at 140 mg/m2 IV on day -3.
16053922|NCT02497404|Drug|Alemtuzumab|Conditioning regimen: Hospital admission will usually take place on the first day of the conditioning regimen. Alemtuzumab will be given at 30 mg subcutaneously on Days -4 and -2 for unrelated donors, and Day -2 for related donors.
16053923|NCT02497404|Radiation|Total Body Irradiation|Conditioning regimen: Hospital admission will usually take place on the first day of the conditioning regimen. Total Body Irradiation (TBI) will be given at 2 doses of 200 cGy each on one day of the conditioning regimen (between days -6 and -3).
16053924|NCT02497391|Drug|Evacetrapib|administered orally
16053925|NCT02497378|Drug|JNJ-54767414 (Daratumumab)|JNJ-54767414 (Daratumumab) will be administered as an Intravenous (IV) infusion at a dose of 16 milligram per kilogram (mg/kg) weekly for the first 3 cycles, on Day 1 of Cycles 4-8 (every 3 weeks), and then on Day 1 of subsequent cycles (every 4 weeks). First 8 Cycles are 21-day cycles; Cycles 9 and onwards are 28-day cycles.
16053926|NCT02497378|Drug|Bortezomib|Bortezomib will be administered at a dose of 1.3 mg/m^2 subcutaneously (SC) on Day 1, 4, 8 and 11 of each 21-day cycle. Eight Bortezomib treatment cycles are to be administered.
16053927|NCT02497378|Drug|Dexamethasone|Dexamethasone will be administered orally at 20 mg on Day 1, 2, 4, 5, 8, 9, 11 and 12 of the first 8 bortezomib treatment cycles (except for Cycles 1-3). In Cycles 1-3, participants receive dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11, 12 and 15. During weeks when the participants receives an infusion of daratumumab, dexamethasone will be administered at a dose of 20 mg IV or orally (PO) (only if IV is not available) before the daratumumab infusion as preinfusion medication.
16053928|NCT02497365|Drug|Besifloxacin|
16053929|NCT02497365|Drug|Tobramycin and Cefazolin|Fortified Tobramycin and Cefazolin eye drops
16053930|NCT02497352|Dietary Supplement|flaxseed|
16053931|NCT02497352|Behavioral|lifestyle modification|
16053932|NCT02497339|Behavioral|Mindfulness training|Using mindfulness training (Thinking and Yoga class) to help women smokers in workplaces to quit smoking
16053933|NCT02497326|Drug|Polyfax & Lignocain gel or silvazine cream|olyfax skin ointment plus Lignocain gel will be applied on superficial PTB area and silver sulphadiazine cream on deep PTB in morning and evening after wound wash.
16053934|NCT02497326|Drug|Topical Heparin|"Heparin solution (5000 IU/ml) will be sprinkled aseptically on burn surface twice a day for the first 2 days, by #27 needle connected via drip set to the drip containing heparin aqueous saline. The dose will be reduced to 75% of day 1 on day 3 and 4 and to 50% on day 5. Administration of heparin saline solution will be in 3 cycles with 5-10 minutes interval"
16053935|NCT02497326|Drug|Tramadol|IV Analgesic ( Inj. Tramadol 10mg/dose) will only be given to the patients (in both groups) having pain score >4, assessed 3 times a day by Numeric Visual Analogue scale (NVAS).
16053936|NCT02497313|Drug|Isotonic saline|
16053937|NCT02497313|Drug|Metformin placebo|
16053938|NCT02497313|Drug|Cholecystokinin|
16053939|NCT02497313|Drug|Metformin|
16053940|NCT02497300|Drug|Spironolactone|
16053941|NCT02497300|Drug|Amiloride|
16053942|NCT02497287|Drug|Esketamine (Intranasal Spray)|Open-Label Induction Phase: Participants will self-administer esketamine intranasally twice per week for 4 weeks as a flexible dose regimen (56 mg or 84 mg for those < 65 years; 28 mg, 56 mg or 84 mg for those >= 65 years). Participants >= 65 years old will start at a dose of 28 mg on Day 1. Optimization/Maintenance Phase: Participants will self-administer esketamine intranasally (56 mg or 84 mg for those < 65 years; 28 mg, 56 mg or 84 mg for those >= 65 years) once weekly then individualized to either once weekly or once every other week based on the severity of depressive symptoms. Transferred-entry responder participants from ESKETINTRD3005 >= 65 years old will start at a dose of 28 mg in Week 5.
16053943|NCT02497287|Drug|Duloxetine (Oral Antidepressant)|Duloxetine could be selected as the oral antidepressant medication by the investigator based on review of Massachusetts General Hospital - Antidepressant Treatment Response Questionnaire (MGH-ATRQ) and relevant prior antidepressant medication information. The minimum therapeutic dose is 60 milligram per day (mg/day).
16053944|NCT02497287|Drug|Escitalopram (Oral Antidepressant)|Escitalopram could be selected as the oral antidepressant medication by the investigator based on review of MGH-ATRQ and relevant prior antidepressant medication information. The minimum therapeutic dose is 10 mg/day. Participants >= 65 years of age will be titrated up to 20 mg/day, but can lower the dose to 10 mg/day for tolerability.
16053945|NCT02497287|Drug|Sertraline (Oral Antidepressant)|Sertraline could be selected as the oral antidepressant medication by the investigator based on review of MGH-ATRQ and relevant prior antidepressant medication information. Sertraline will be titrated up to a dose of 150 mg/day, but if not tolerated the dose can be reduced to the minimum therapeutic dose of 50 mg/day.
16053946|NCT02497287|Drug|Venlafaxine Extended Release (XR) (Oral Antidepressant)|Venlafaxine Extended Release could be selected as the oral antidepressant medication by the investigator based on review of MGH-ATRQ and relevant prior antidepressant medication information. Venlafaxine Extended Release will be titrated for participants < 65 years of age up to a dose of 225 mg/day, but if not tolerated the dose can be reduced to the minimum therapeutic dose of 150 mg/day. For participants >= 65, it can be titrated up to a dose of 150 mg/day, but if not tolerated the dose can be reduced to the minimum therapeutic dose of 75 mg/day.
16053948|NCT02497261|Procedure|Double-blind placebo-controlled peanut challenge|Children who are avoiding peanut will be gradually introduced to smoothies containing and not containing peanut, to see if they are able to tolerate eating peanut. This challenge does not change a child's ability to tolerate peanut, but will determine which children avoiding peanut are allergic to peanut and which children are not allergic and may begin eating peanut.
16053949|NCT02497248|Procedure|Pulmonary vein ablation|Simultaneous biatrial endocardial electroanatomical mapping by high-density basket catheter (64 pin) and customized body surface mapping (57 electrodes) followed by circumferential pulmonary vein ablation.
16053950|NCT02497235|Drug|TAK-935|TAK-935 oral solution.
16053951|NCT02497235|Drug|[18F]MNI-792 (tracer)|[18F]MNI-792 injection.
16053952|NCT02497222|Drug|RNS60|
16053953|NCT02497222|Drug|Normal Saline|
16053954|NCT02497196|Device|Active tPCS|A current intensity of 2mA and a stimulation frequency range of 6-10 Hz will be used with a peri-aurical ear-clip electrode montage for 20 minutes.
16053955|NCT02497196|Device|Active tDCS|A current intensity of 2.0 mA will be used for 20 minutes. The electrodes that will be used will be standard sponge electrodes. The anode will be placed over left motor cortex. The cathode electrode will be placed over the contralateral supraorbitofrontal area.
16053956|NCT02497196|Device|Sham tPCS|Sham tPCS stimulation will consist of applying the same parameters as for active, but the corresponding device will be turned off after 30 seconds, as to simulate the initial sensation of the active current. A current intensity of 2mA and a stimulation frequency range of 6-10 Hz will still be used (only this will be turned off after 30 seconds using ramping) with a peri-aurical ear-clip electrode montage.
16053957|NCT02497196|Device|Sham tDCS|Sham tDCS stimulation will consist of applying the same parameters as for active, but the corresponding device will be turned off after 30 seconds, as to simulate the initial sensation of the active current. A current intensity of 2.0 mA will still be used (but turned off after 30 seconds using ramping). The electrodes that will be used will be same, standard sponge electrodes. The anode will be placed over the left motor cortex The cathode electrode will be placed over the contralateral supraorbitofrontal area.
16053958|NCT02497183|Device|ultrasound|A repeat ultrasound exam following oral contrast material consumption
16053959|NCT02497183|Other|iodine based solution of oral contrast material|A solution of oral contrast material that is routinely used in our institution prior to performing a computed tomographic (CT) examinations of the gastrointestinal tract will be given prior to performing the repeat ultrasound/
16053960|NCT02497170|Behavioral|Education of goal setting and achievement|Education of American Association of Diabetes Educations 7 behavioral goals and how to achieve them
16053961|NCT02497157|Drug|Oxaliplatin (L-OHP)|
16053962|NCT02497157|Drug|Irinotecan hydrochloride hydrate (CPT-11)|
16053963|NCT02497157|Drug|Continuous intravenous infusion of fluorouracil (CIV 5-FU)|
16053964|NCT02497157|Drug|Levofolinate calcium (l-LV)|
16053965|NCT02497157|Drug|Bevacizumab (Bmab)|
16053966|NCT02497144|Other|NMES Group|Neuromuscular electrical stimulation
16053967|NCT02497144|Other|Control Group|Breathing exercises
16053968|NCT02497131|Drug|Brentuximab Vedotin|Brentuximab vedotin will be administered on Day 1 of each 21-day cycle. The dose of brentuximab vedotin is 1.8 mg/kg and is administered by outpatient IV infusion given over approximately 30 minutes
16053969|NCT02497118|Drug|Endostatin|Endostatin,7.5mg/m^2,intravenous, d1-14;
16053970|NCT02497118|Drug|Vinorelbine|vinorelbine,25mg/m^2,intravenous, d1, d8;
16053971|NCT02497118|Drug|Cisplatin|Cisplatin，75mg/m^2 intravenous,divide into d1-3
16053972|NCT02497105|Other|Ketogenic Diet|Dietary
16053973|NCT02497092|Other|Technique of injection|
16053974|NCT02497079|Device|Nested PCR for formalin-fixed tissues|For nested PCR, formalin-fixed paraffin-embedded tissues were incubated in 1 mL of xylene at 60°C for 30 min and then centrifuged for 10 min. Paraffin and the supernatant were removed from the samples after centrifugation. The same procedures were repeated until deparaffinization was complete. After adding 1 mL of alcohol, the samples were centrifuged for 5 min, and the supernatant was removed. The sample was then air-dried as a pellet. DNA was extracted using QIAamp (Qiagen, Valencia, CA, USA). PCR amplifications were performed using Mycobacterium tuberculosis IS6110 primers. The first round using outer primers and the second round using inner primers amplified a 256- and 181-bp fragment, respectively. Finally, the PCR products were visualized in a 2% agarose gel.
16053975|NCT02497079|Device|Nested PCR for fresh tissues|For nested PCR with specimens in sterile saline, DNA was extracted using QIAamp (Qiagen, Valencia, CA, USA). PCR amplifications were performed using Mycobacterium tuberculosis IS6110 primers. The first round using outer primers and the second round using inner primers amplified a 256- and 181-bp fragment, respectively. Finally, the PCR products were visualized in a 2% agarose gel.
16053976|NCT02497079|Device|Real-time PCR for fresh tissues|For real-time PCR, specimens in sterile saline were filtered and 1 mL of phosphate based saline was added. After centrifugation for 3 min, the supernatant was removed. Next, 50 μL of extraction buffer was added to the sample, and the sample was heated at 100°C for 20 min. After centrifugation for 3 min, the supernatant was used in PCR. Real-time PCR was performed using the AdvanSure TB/NTM real-time PCR kit. Three channels were used in the real-time PCR reaction (Mycobacterium tuberculosis complex, mycobacteria, and internal control). Signals for FAM, HEX, and Cy5 were measured in each channel. Mycobacterium tuberculosis was considered present if the cycle threshold of rpoB was less than 35 on each signal and greater than or equivalent to that of IS6110.
16053977|NCT02497066|Other|Neuropathic pain cream|Subjects will apply the cream to the painful area.
16053978|NCT02497066|Other|Nociceptive pain cream|Subjects will apply the cream to the painful area.
16053979|NCT02497066|Other|Mixed pain cream|Subjects will apply the cream to the painful area.
16053980|NCT02497053|Drug|pemetrexed/platinum chemotherapy|Four cycles of pemetrexed/platinum chemotherapy
16053981|NCT02497053|Drug|Pemetrexed/platinum chemotherapy|Six cycles of pemetrexed/platinum chemotherapy
16053982|NCT02497040|Drug|Levobupivacaine|local injection
16053983|NCT02497040|Drug|Bupivacaine|local injection
16053984|NCT02497040|Drug|placebo|local injection
16053985|NCT02497027|Other|pharmacogenetic testing|pharmacogenetic testing report released to physician at 4 weeks post enrollment
16053986|NCT02497027|Other|pharmacogenetic testing|pharmacogenetic testing report released to physician at 12 weeks post enrollment
16053987|NCT02497014|Device|1 Stent|Stenting of main vessel should be undertaken with a wire jailed in the side vessel to preserve side vessel flow and access. Stent diameter should be chosen according to diameter of the main vessel immediately distal to the bifurcation. Distal left main should be dilated with a short non-compliant balloon. Side vessel should be rewired and a kissing balloon inflation should be undertaken. Balloon sizes should be according to the diameter of the main and side vessel with individual high pressure inflation followed by a final lower pressure kiss dilatation. Proximal stented portion in the left main coronary artery should be dilated to full expansion using either low pressure dilatation of the kissing balloon pair or a separate individual balloon. It is preferred that non-compliant balloons should be used to limit overstretching of vessels. In case of specific situations described in the protocol the operator may choose to implant a side vessel stent, using same process as described above.
16053988|NCT02497014|Device|2 Stents|"Coronary guide wires should be passed to LAD and Cx/intermediate arteries respectively. One should be designated the main vessel and one should be designated the side vessel. The planned dual stent technique is at the discretion of the operator but should be one of culotte, minicrush, T or TAP. If a crush procedure is chosen, it should ideally be of the DK variety. Stent diameter should be chosen according to the diameter of the vessel immediately distal to the bifurcation. Wire jail, POT, non-compliant balloons, high pressure individual ostial dilatations and final dilatation of the stented proximal left main should be used in accordance with the advice of the EBC. Further treatment to proximal or distal aspects of the main vessel or side vessel can be continued at the discretion of the operator. At any stage, proximal or distal dissections may be treated as required with further stent implantations. At any stage, post-dilatations may be undertaken to optimise stent expansion."
16053989|NCT02497001|Drug|BGF MDI 320/14.4/9.6 μg|Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler [MDI])
16053990|NCT02497001|Drug|GFF MDI (PT003) 14.4/9.6 μg|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI)
16053991|NCT02497001|Drug|BFF MDI (PT009) 320/9.6 μg|Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI)
16053992|NCT02497001|Drug|Symbicort® Turbuhaler® (TBH) Inhalation Powder|
16053993|NCT02496988|Drug|Temozolomide|Capsules supplied in 5-mg, 20-mg, 100-mg, 140-mg, 180-mg, and 250-mg strengths; dosed at 200 mg/m2/day for 5 consecutive days, repeated every 28 days
16053994|NCT02496988|Biological|CIK|The patients received autologous cytokine-induced killer cells transfusion one week after Temozolomide treat
16053995|NCT02496975|Drug|Cyclosporine A|Participants will receive 2.5mg/kg load then 5mg/kg qd continuous infusion x 3 days (72hours)
16053996|NCT02496975|Other|Placebo|Participants will receive 2.5mg/kg load then 5mg/kg qd continuous infusion x 3 days (72hours)
16053997|NCT02496962|Drug|Atorvastatin|atorvastatin were taken daily for 5 days
16053998|NCT02496962|Drug|placebo|placebo were taken daily for 5 days
16053999|NCT02496949|Drug|Icaritin|600mg,800mg two doses, Bid, continuous dosing for 56 days, to assess the safety,tolerance,pharmacokinetics and efficacy of icaritin
16054000|NCT02496936|Other|SFA|High saturated fatty acid/SFA oil source
16054001|NCT02496936|Other|MUFA|High monounsaturated fatty acid/MUFA oil source
16054002|NCT02496936|Other|PUFA-LA|High polyunsaturated fatty acid (linoleic)/PUFA-LA oil source
16054003|NCT02496936|Other|ALA|High polyunsaturated fatty acid (alpha-linolenic)/ALA oil source
16054004|NCT02496936|Other|LCn3|High polyunsaturated fatty acid (omega-3)/LCn3 oil source
16054005|NCT02496923|Device|High flow nasal oxygen therapy (Optiflow™)|
16054006|NCT02496923|Device|Standard oxygen therapy (Hudson Type face mask or nasal prongs)|
16054007|NCT02496910|Drug|YH22162|
16054008|NCT02496910|Drug|Telmisartan/Amlodipine 80/5 mg (FDC)|
16054009|NCT02496910|Drug|Chlorthalidone 25mg|
16054010|NCT02496897|Biological|FP-02.2 Vaccine|Synthetic Peptide Hepatitis B Vaccine
16054011|NCT02496897|Other|Placebo|Placebo
16054012|NCT02496897|Other|IC31® Adjuvant|IC31® Adjuvant
16054013|NCT02496884|Drug|DS-5565|DS-5565 7.5 mg tablet for oral use
16054014|NCT02496884|Drug|Placebo|Placebo tablet for oral use to match DS-5565 7.5 mg tablet
16054015|NCT02496871|Behavioral|Group Phone Calls|University of Kansas Weight Management Program - Group Phone calls
16054016|NCT02496871|Behavioral|Social Media|University of Kansas Weight Management Program - Social Media (Facebook)
16054017|NCT02496845|Drug|VL#FIA3-30|Vasoactive dual treatment (MH30-01 & IS045-01)
16054018|NCT02496832|Drug|18F-Fluoroazomycin arabinoside|
16054019|NCT02496819|Other|Meta-cognitive self-regulated learning intervention|It is a 12-week intervention programme with one 60 minutes sessions per week.
16054020|NCT02496819|Other|Sensory integration intervention|It is a 12-week intervention programme with one 60 minutes sessions per week.
16054021|NCT02496819|Other|Activity-based intervention|It is a 12-week intervention programme with one 60 minutes sessions per week.
16054022|NCT02496806|Dietary Supplement|Seaweed extract|Treatment capsule containing seaweed extract (treatment)
16054023|NCT02496793|Behavioral|Peer-facilitated community support group|Support groups were composed of up to 20 women from community. Peer facilitator facilitated a total of 6 groups of a maximum of 20 women each. Women were exposed to 8 two hour sessions. Facilitators gave activities in support of MCH/PMTCT. Group met twice a month for four months. The support group meetings took place in the community at a convenient location for those attending (e.g. village meeting point, churches, schools or individual households). With local support through community leaders, the intervention involved trained peer facilitators working with pregnant and post-partum women to form ANC and PNC support groups through which they will present information on general maternal and child health and PMTCT specific topics using participatory learning and problem-solving approaches.
16054024|NCT02496780|Drug|novolog insulin|3x daily rapid-acting insulin
16054025|NCT02496780|Drug|levemir insulin|basal insulin once a day
16054026|NCT02496780|Drug|placebo|once or 3x daily
16054027|NCT02496767|Drug|Tirasemtiv|
16054028|NCT02496767|Drug|Placebo tablets|
16054029|NCT02496754|Drug|GnRH-a|In experimental group, patients use long term GnRH-a; Patients' serum or follicle fluid will be collected if needed.
16054030|NCT02496754|Drug|GnRH-a|In control group, patients use short term GnRH-a. Patients' serum or follicle fluid will be collected if needed.
16054035|NCT02496728|Behavioral|Educational Materials|Educational materials regarding healthy behaviors.
16054036|NCT02496715|Drug|Fluticasone propionate 100 mcg / salmeterol 50 mcg|Brand inhaler containing pMDI containing fluticasone and salmeterol
16054037|NCT02496715|Drug|Generic fluticasone propionate 100 mcg / salmeterol 50 mcg|Generic inhaler containing pMDI containing fluticasone and salmeterol
16054038|NCT02496715|Drug|Placebo|Placebo inhaler
16054039|NCT02496702|Device|Training on Interactive Modulare Tiles|Training with the Interactive Modulare Tiles
16054040|NCT02496689|Biological|asfotase alfa|Patients participating in this program will receive 6 mg/kg/week asfotase alfa (administered at a dosage regimen of 1 mg/kg 6 times per week or 2 mg/kg 3 times per week at the discretion of the Investigator) by SC injection. During follow-up visits, dose adjustments to account for changes in body weight will be made. Additional incremental dose adjustments for lack of efficacy or safety reasons may also be decided upon by the Investigator in consultation with the Alexion Medical Monitor.
16054041|NCT02496676|Dietary Supplement|Magnesium Threonate|In Part I, patients within each cohort will be randomized into 2 arms. Each arm will receive 12 weeks of either oral magnesium L-threonate or placebo followed by crossover treatment for another 12 weeks. Patients in cohort 1 who experience >=0.5-log reduction in the number of EBV-infected B cells and patients in cohort 2 who experience greater than or equal to >=2-fold increase in NKG2D receptor expression on CDS T cells during oral magnesium treatment as compared to placebo will have completed the study. Patients who do not meet these respective criteria will undergo a 2-week washout and transition to Part II in which they will be hospitalized to receive 3 days of IV MgS04. These patients will then restart escalating doses of oral magnesium and continue for 24 weeks, at which point participation will be complete.
16054042|NCT02496676|Other|Placebo|Participants will receive 12 weeks of placebo and 12 weeks of magnesium threonate. Will be dose escalated based on weight
16054043|NCT02496663|Biological|Necitumumab|Given IV
16054044|NCT02496663|Drug|Osimertinib|Given PO
16054045|NCT02496650|Drug|Dexmedetomidine|DEX infusion in doses 0,2-1,4 μg/kg/hr
16054046|NCT02496637|Behavioral|Appetite Awareness|Appetite Awareness Training (AAT) is an approach to increasing eating regulation through training individuals to eat in response to their appetite cues rather than external or emotional cues
16054047|NCT02496637|Behavioral|Nutrition Education|Nutrition education provides information about energy balance, dietary guidelines, portion and serving sizes, and other general dietary information.
16054048|NCT02496624|Other|Cone Beam CT localization and placement of microcoil|Cone Beam CT localization and placement of microcoil
16054049|NCT02496611|Drug|Exenatide extended-release for injectable suspension (BYDUREON™)|
16054050|NCT02496611|Dietary Supplement|Meal Replacement Therapy|A short-term meal replacement induction period designed to achieve >5% BMI reduction in 1, 2, or 3 months.
16054051|NCT02496598|Procedure|In Vitro Follicle Activation (IVA)|Laparoscopic removal of ovarian tissue, followed by in vitro activation of dormant ovarian follicles and autografting back to the patient for follicle growth and egg retrieval.
16054052|NCT02496598|Drug|Follicle Activation|Ovarian cortical pieces will be treated in vitro with a PTEN activator (bpV(hopic)) and a PI3K inhibitor (740YP) in vitro to activate primordial ovarian follicles, prior to autografting.
16054053|NCT02496585|Drug|Nintedanib|
16054054|NCT02496585|Drug|Prednisone|
16054055|NCT02496585|Other|Placebo|
16054056|NCT02496572|Drug|Short course MDR-TB treatment regimen|"Intensive phase:
~Pyrazinamide (Z) + Ethambutol (E) + Isoniazid (H) + Moxifloxacin (Mfx) + Capreomycin (Cm) + Prothionamide (Pto) + Clofazimine (Cfz) for at least 4 months and until one negative culture is documented with a maximum of 6 months duration.
~Continuation phase:
~Continuation phase of Pyrazinamide (Z) + Ethambutol (E) + Moxifloxacin (Mfx) + Prothionamide (Pto) + Clofazimine (Cfz) for fixed 5 months duration."
16054057|NCT02496559|Procedure|Pre-consultation CRP|Use of CRP test on all children with fever before the consultation (intervention) compared to where the doctor requests a CRP test (no intervention)
16054058|NCT02496546|Drug|LEO 32731 cream|Applied for 3 weeks
16054059|NCT02496546|Drug|LEO 32731 cream vehicle|Applied for 3 weeks
16054060|NCT02496533|Procedure|Hand Massage|The hand massage procedure comprises 4 minutes of manipulation of the subject's hands (2 minutes per hand) by a skilled massage therapist or appropriately trained staff.
16054061|NCT02496520|Biological|dendritic cells|vaccines with dendritic cells pulsed with tumor lysate
16054062|NCT02496520|Procedure|Surgery as needed by the patient´s tumor and stage|
16054063|NCT02496520|Drug|Chemotherapy as needed by the patient´s tumor and stage|
16054064|NCT02496520|Radiation|Radiation therapy as needed by the patient´s tumor and stage|
16054065|NCT02496507|Other|Sit-stand workstation|After baseline, each participant had a sit-stand workstation installed on their existing workplace desk. A single or dual monitor WorkFit-A with Worksurface+ workstation was installed, dependent on the number of monitors. The monitor(s) and keyboard were housed on the workstation and the workstation could be quickly raised up and down by hand to enable seated or standing work. Participants were not prescribed an amount of time to use the station. Ergotron Ltd provided and installed the workstations and gave participants basic face-to-face training and ergonomic information on correct use. Participants received a web link to manufacturer ergonomic guidelines via an email from the research team. After end-intervention data collection, manufacturer staff uninstalled the workstations.
16054066|NCT02496494|Drug|Tacrolimus|Tacrolimus for maintenance immunosupression in kidney transplant recipients
16054067|NCT02496481|Behavioral|Motivational Interviewing|Motivational interviewing (MI) in the ED has been used to encourage a variety of health behaviors among at-risk patients. In this study, researchers will employ motivational interviewing with half of the study participants to investigate the effects of the technique on child passenger restraint behaviors in a population of parents of children birth to 10 years of age.
16054068|NCT02496481|Behavioral|Tailored brochure|Tailored Print materials will be mailed to half of participants to investigate the effects of using patient-centered educational materials compared with generic educational materials to influence child passenger restraint behaviors in a population of parents of children birth to 10 years of age.
16054069|NCT02496455|Procedure|cesarean section|Women in 36 to 40 weeks of pregnancy undergoing cesarean section by Pfannenstiel technique
16054070|NCT02496455|Drug|Opioid Tramadol|Tramadol will be administered via patient controlled analgesia (PCA) pump in the postoperative period
16054071|NCT02496442|Device|Aqueduct|Using Aqueduct in procedures to continuously supply the irrigation solutions
16054072|NCT02496429|Device|BrownieForSymphony use|Professional will use the BrownieForSymphony Pumpset in their daily work. hospitalized lactating woman will pump with the BrownieForSymphony Pumpset
16054073|NCT02496416|Behavioral|Aquatic Exercise Program|The aquatic exercise program will consist of 45 minute classes held 3 days/week for 8 weeks (18 hours total). The program is based on guidelines provided by the National Multiple Sclerosis Society (NMSS) and will be led by an aquatic fitness instructor certified to teach individuals with MS at the YMCA in Scotch Plains-Fanwood. The exercises will focus on improving flexibility, balance and strength. Equipment such as water mitts, paddles, noodles and bands will be used to increase the level of difficulty as needed.
16054074|NCT02496416|Behavioral|Stretching Program|The stretching program will consist of 45 minute classes held 3 days/week for 8 weeks (18 hours total). The program is based on guidelines provided by the National Multiple Sclerosis Society (NMSS) and will be conducted online via a secure video-conferencing website.
16054075|NCT02496403|Behavioral|Standard Medical Management (SMM)|SMM is designed to provide basic advice about opioid dependence and encouragement to adhere to treatment recommendations. Sessions provide support and monitoring of medication compliance, dose, withdrawal, adverse effects, and discussion of medical complications of opioid and other drug use. Early in treatment, the focus will be on helping patients adjust to the medications (e.g., monitoring withdrawal or other adverse symptoms, tolerating discomfort, curtailing illicit drug use, and referral to self-help). As treatment progresses, the practitioner may focus more on educating the patient about the social and behavioral factors perpetuating addiction and encourage behavioral and lifestyle change to support recovery.
16054076|NCT02496390|Biological|Autologous|Patients will have their normal microbiome reduced using an oral preparation (pico-salax) as used for routine colonic preparation for colonoscopy. • Administration of the FMT will be via a nasoduodenal tube inserted at the time of gastroscopy. Dosage - approx 100ml previously frozen fecal sample obtained from the patient prior to colonic preparation.
16054077|NCT02496390|Biological|Allogeneic|Patients will have their normal microbiome reduced using an oral preparation (pico-salax) as used for routine colonic preparation for colonoscopy. • Administration of the FMT will be via a nasoduodenal tube inserted at the time of gastroscopy. Dosage - approx 100ml previously frozen fecal sample obtained from a lean donor prior to colonic preparation.
16054078|NCT02496377|Drug|ferrous glycine sulfate Tardyferon|
16054079|NCT02496377|Drug|Epoetin Alfa|
16054080|NCT02496377|Drug|ferric carboxymaltose Ferinject|
16054081|NCT02496364|Other|Observational|
16054082|NCT02496351|Device|TENS INTERVENTION|24 hours of TENS treatment in the immediately postoperative of limb amputation
16054083|NCT02496338|Other|Training program about menopausal health isues|A three sessions raining program about health issues during menopause for spouses of 45-60 years old
16054084|NCT02496325|Procedure|Ultrasound guided transperineal pudendal nerve block|Children under general anesthesia were positioned supine, flexed legs and balls of the feet joined. A 12 MegaHertz (MHz) (38 mm) ultrasound probe was positioned on a horizontal axis passing through the ischial tuberosity, previously palpated.The probe was then moved medially on the axis, until the rectum appeared. Pudendal artery was identified if possible, using colour Doppler. The needle (22 Ga, 50 mm) was then introduced at the middle of the superior edge of the probe, in an out-of-plane approach. Tip of the needle was identified by direct vision, through displacement of adjacent anatomical structures or with saline injection. Nerve stimulation was started after placement of the tip of needle in the ischiorectal fossa, before local anaesthetic injection. After a negative aspiration test, a mix of Ropivacaine 2 % and clonidine 0.2µg/kg was injected in the ischiorectal fossa under ultrasound guidance.
16054085|NCT02496312|Behavioral|Evaluation of Apathy Close to Real Life Situation|Quantitative Evaluation of Apathy Close to Real Life Situation by Means of a Multimodal Sensor System Integrated.
16054086|NCT02496299|Drug|Dexamethasone|Comparison of analgesic effects of dexamethasone with plain bupivacaine during caudal blocks in children
16054087|NCT02496299|Drug|Bupivacaine|Comparison of analgesic effects of dexamethasone with plain bupivacaine during caudal blocks in children
16054088|NCT02496286|Drug|Intraperitoneal Bevacizumab|Bevacizumab 200mg diluted in 250 ml of normal saline
16054089|NCT02496273|Biological|CTL|Mononuclear cells (Dendritic Cell,DC precursor) were isolated from the peripheral blood of gasric cancer by density gradient centrifugation and infected with rAAV/CEA virus.Maturation of the DC was induced by granulocyte-macrophage colony-stimulating factor (GM-CSF), interleukin-4 (IL-4) and tumor necrosis factor-alpha(TNF-alpha). On day 7, the DCs were collected and mixed with T cells at the ratio of 1 to 20 to induce cytotoxic T lymphocytes (CTL).The cells will be proliferated and infused by intravenous (IV) infusion into the patient.
16054090|NCT02496260|Procedure|Research Cardiac MRI|Cardiac MRI has increased use in evaluating structural and functional cardiac pathologies. For detection of coronary artery disease, MRI outperforms SPECT and dobutamine stress echocardiography for the detection of ischemia. MRI also can detect wall-motion abnormalities and other dysfunction. Dynamic contrast-enhanced MRI (DCE-MRI) can evaluate microvascular parameters such as vessel permeability and fluid volume fraction as an assessment of tissue perfusion. Cardiac MRI holds promise for early detection of subclinical cardiac abnormalities after radiotherapy and could potentially identify patients for intervention to prevent cardiac events. All patients will follow the protocol calendar requiring research MRIs, but will receive standard radiation treatment determined by their physician. Treatment will not be altered based on MRI.
16054091|NCT02496260|Procedure|Biomarkers|"We have identified potential candidates based on other processes affecting heart function in a way similar to probable mechanisms of RT-related injury. For fibrosis and left ventricular dysfunction, these include galectin-3 and N-terminal-Pro brain natriuretic peptide. For myocyte destruction, troponin; for inflammation and oxidative stress, C-reactive protein, myeloperoxidase, and growth differentiation factor 15. Additional blood will be collected and stored for future assessment of other candidate biomarkers.
~All patients will follow the calendar of protocol required research blood draws for biomarker collection, but will receive standard radiation treatment as clinically indicated by their physician. Treatment will not be altered based upon the data collected from these samples."
16054092|NCT02496247|Other|Canned Herring|Families with children in this study arm will receive a weekly ration of herring throughout the 8-10 week study period (2 cans herring/day per study child).
16054140|NCT02495896|Biological|Recombinant EphB4-HSA Fusion Protein|Given IV
16054093|NCT02496221|Drug|Albiglutide 50 mg|Albiglutide 50 mg pen is a single-use fixed dose, fully disposable pen injector system for SC delivery in the abdomen containing 67 mg lyophilized albiglutide and 0.65 mL diluents designed to deliver a dose of 50 mg in a volume of 0.5 mL after reconstitution
16054094|NCT02496221|Drug|Placebo|Placebo is a single-use fixed dose, fully disposable pen injector system for SC delivery of 0.5 mL injector volume in the abdomen
16054095|NCT02496221|Drug|CCK (Kinevac)|CCK (Kinevac) will be infused intravenously. Kinevac is supplied in vials containing 5 microgram (mcg)/vial. Infusion prepared aseptically by adding 5 mL of Sterile Water for Injection United States Pharmacopeia (USP) to the vial to create a solution of 1 mcg/mL. Infuse 0.003 mcg/kg dose in 100 mL of Sodium Chloride Injection USP, 0.9%
16054096|NCT02496208|Drug|Cabozantinib S-malate|Given PO
16054097|NCT02496208|Biological|Ipilimumab|Given IV
16054098|NCT02496208|Biological|Nivolumab|Given IV
16054099|NCT02496182|Drug|Placebo|Placebo tablet only with the excipients of the Pirfenidone tablet
16054100|NCT02496182|Drug|Pirfenidone|Conventional Treatment (Prednisone+Azathioprine) plus Pirfenidone 1800 mg
16054101|NCT02496182|Drug|Pirfenidone|Conventional Treatment (Prednisone+Azathioprine) plus Pirfenidone 1200 mg
16054102|NCT02496169|Device|eucaLimus|Percutaneous Coronary Intervention (PCI)
16054103|NCT02496156|Behavioral|Usual Clinical Practice|Diabetes management and education related to insulin pump or continuous glucose monitor as currently practiced at the enrolling site.
16054104|NCT02496156|Behavioral|Shared Medical Decision Making|Access to and use of multimedia decision aid websites to facilitate adolescent and parent decision making about incorporating these devices into the diabetes management regimen.
16054105|NCT02496143|Drug|EC-18|EC-18 will be supplied as 500 mg Softgel capsules. The study will include up to four sequential dose cohorts. Six subjects in each cohort will be randomized to receive EC-18: 500, 1000, 2000, or 4000 mg by oral administration of 1, 2, 4, and 8 EC-18 capsules, for Cohorts 1, 2, 3 or 4, respectively.
16054106|NCT02496143|Drug|Placebo|Placebo will be supplied as Softgel capsules. The study will include up to four sequential dose cohorts. Two subjects in each cohort will be randomized to placebo and will receive 1, 2, 4 or 8 placebo capsules for Cohorts 1, 2, 3 or 4, respectively.
16054107|NCT02496117|Procedure|Electrical mapping, nerve stimulation checked renal denervation procedure|
16054108|NCT02496117|Procedure|Electrial mapping, nerve stimulation guided renal denervation procedure|
16054109|NCT02496104|Behavioral|Package n°1 of the APIB|
16054110|NCT02496091|Device|ATLANTIS Abutment|
16054111|NCT02496078|Drug|Daclatasvir|Daclatasvir tablet 60mg
16054112|NCT02496078|Drug|Asunaprevir|Asunaprevir soft capsule 100 mg
16054113|NCT02496065|Drug|BLZ-100|
16054114|NCT02496052|Procedure|dried biological amnion graft|Uterine application of amnion membrane following hysteroscopic adhesiolysis. Other Name: Human amnion membrane
16054115|NCT02496052|Device|Foley balloon|Device: Foley balloon Uterine application of Foley balloon
16054116|NCT02496052|Drug|estradiol valerate tablets+dydrogesterone Tablets|oral estradiol valerate tablets+dydrogesterone Tablets
16054117|NCT02496039|Drug|NUEDEXTA®|NUEDEXTA® only
16054118|NCT02496026|Device|tDCS plus wrist robot therapy|Patients receive robotic rehabilitation session while tDCS stimulator is switched on
16054119|NCT02496026|Device|Sham tDCS plus wrist robot therapy|Patients receive robotic rehabilitation session while tDCS stimulator is switched off.
16054120|NCT02496013|Drug|68Ga-NEB|68Ga-NEB were injected into the patients before the PET/CT scans
16054121|NCT02496000|Drug|ORMD-0801|Oral Insulin
16054122|NCT02496000|Drug|Placebo Comparator|Placebo
16054123|NCT02495974|Drug|enzalutamide|oral
16054124|NCT02495948|Device|Lotrafilcon B contact lenses|
16054125|NCT02495948|Device|Samfilcon A contact lenses|
16054126|NCT02495948|Device|Hydrogen peroxide solution|Used as a cleaning, disinfection, and storage solution for silicone hydrogel and soft contact lenses
16054127|NCT02495948|Device|Saline solution|Used for rinsing contact lenses, as needed
16054128|NCT02495935|Device|OkuStim®|Transcorneal Electrical Stimulation delivered by the Okuvision Stimulation Set manufactured by Okuvision GmbH, Reutlingen, Germany
16054129|NCT02495935|Device|Sham-OkuStim®|Transcorneal Electrical Stimulation delivered by the Okuvision Stimulation Set manufactured by Okuvision GmbH, Reutlingen, Germany
16054130|NCT02495922|Drug|elotuzumab|10 mg/kg in the vein( i.v) on day 1,8 and 15 in induction cycle 1 and 2, on day 1 and 11 in induction cycle 3 and 4 (Arm B1 and B2). 10 mg/kg i.v. on day 1,8 and 15 in consolidation cycle 1 and 2 (Arm A2 and B2), 10 mg/kg i.v. on day 1 and15 in maintenance cycle 1-6, 10 mg/kg i.v. on day 1 in maintenance cycle 7-26 (Arm A2 and B2)
16054131|NCT02495922|Drug|Lenalidomide|25 mg per os on day 1-14 in induction cycle 1-4, 25 mg p.o. on day 1-14 in consolidation cycle 1 and 2, 10 mg p.o. on day 1-28 in maintenance cycle 1-3, 15 mg p.o. on day 1-28 in maintenance cycle 4-26 (all arms)
16054132|NCT02495922|Drug|Bortezomib|all arms: 1,3 mg/m^2 subcutaneous on day 1, 4, 8 and 11 in 4 induction cycles, 1,3 mg/m^2 subcutaneous on day 1, 8 and 15 in 2 cycles of consolidation
16054133|NCT02495922|Drug|Dexamethasone|"20 mg per os on day 1,2 and 4,5 and 8,9 and 11,12 and 15 in induction cycles 1 and 2. 20 mg per os on day 1,2 and 4,5 and 8,9 and 11,12 in induction cycles 3 and 4 (Arms A1 and A2).
~8 mg per os and 12 mg i.v. on day 1, 8 and 15 and 20 mg per os on days 2,4,5, 9, 11 and 12 in induction cycles 1 and 2. 8 mg per os and 12 mg i.v. on day 1, and 11, 20 mg per os on days 2,4,5,8, 9, and 12 in induction cycles 3 and 4 (Arms B1 and B2).
~20 mg per os on days 1,2, 8,9, 15 and 16 in both cycles of consolidation (Arms A1 and B1). 8 mg per os and 12 mg i.v. on days 1, 8 and 15 and 20 mg per os on days 2, 9 and 16 in both consolidation cycles (Arms A2 and B2).
~12 mg per os on day 1 and 15 in maintenance cycles 1-6, 12 mg per os on day 1 of maintenance cycles 7 and following (Arms A1 and B1). 4 mg per os and 8 mg i.v. on day 1 and 15 in maintenance cycles 1-6, 4 mg per os and 8 mg i.v. on day 1 of maintenance cycles 7 and following (Arms A2 and B2)."
16054134|NCT02495896|Drug|Cisplatin|Given IV
16054135|NCT02495896|Drug|Docetaxel|Given IV
16054136|NCT02495896|Drug|Gemcitabine Hydrochloride|Given IV
16054137|NCT02495896|Other|Laboratory Biomarker Analysis|Correlative studies
16054138|NCT02495896|Drug|Paclitaxel Albumin-Stabilized Nanoparticle Formulation|Given IV
16054139|NCT02495896|Other|Pharmacological Study|Correlative studies
16054141|NCT02495883|Other|Ethanol|50ml of 40% Ethanol
16054142|NCT02495883|Drug|Propranolol|Beta blocker
16054143|NCT02495870|Other|Pork|
16054144|NCT02495857|Device|Hyaluronate Injectable Viscosupplement|Test product of a 1% sodium hyaluronate for injection
16054145|NCT02495857|Device|Euflexxa IA injection|Brand product of a 1% sodium hyaluronate for injection
16054146|NCT02495857|Device|Placebo|0.9% sodium chloride, sterile
16054147|NCT02495844|Drug|UCB0942|Active substance: UCB0942 Pharmaceutical form: Film-coated tablet Concentration: 200 mg Route of Administration: Oral use
16054148|NCT02495844|Drug|UCB0942|Active substance: UCB0942 Pharmaceutical form: Film-coated tablet Concentration: 100 mg Route of Administration: Oral use
16054149|NCT02495844|Drug|Placebo|Pharmaceutical form: Film-coated tablet Route of administration: Oral use
16054150|NCT02495831|Drug|Diclofenac sodium|Diclofenac sodium 50 mg single dose
16054151|NCT02495831|Drug|Diclofenac sodium and safinamide|Diclofenac 50 mg single dose and safinamide 200 mg single dose
16054152|NCT02495818|Procedure|Lidocaine|Suprascapular Nerve Block Guided by Ultrasound with 5ml lidocaine at 2%.
16054153|NCT02495818|Procedure|Saline solution|Suprascapular Nerve Block Guided by Ultrasound with 5ml saline solution
16054154|NCT02495818|Other|Homemade exercises|Codman and Hughston exercises.
16054155|NCT02495805|Procedure|Continuous proximal adductor canal block|Subjects will be randomized into 2 groups: those who will receive a continuous proximal adductor canal block (ACB) and those who will receive a continuous femoral nerve block (FNB).
16054156|NCT02495805|Procedure|Continuous femoral nerve block|Subjects will be randomized into 2 groups: those who will receive a continuous proximal adductor canal block (ACB) and those who will receive a continuous femoral nerve block (FNB).
16054157|NCT02495792|Device|Biofeedback Sensor|Tibia accelerometer strapped to distal tibia to detect tibial shock
16054158|NCT02495779|Drug|emtricitabine/tenofovir|Short-term episodic use for 2-3 weeks.
16054159|NCT02495779|Behavioral|CBT-based counseling|Brief CBT-based counseling to promote adherence
16054160|NCT02495766|Drug|XCEL-MC-ALPHA|Single infusion
16054161|NCT02495766|Drug|Placebo|Single infusion
16054162|NCT02495753|Procedure|Vaginal Cleansing|The vagina will be prepped in two passes with sponge sticks soaked in 1% povidone-iodine solution from a prepackaged sterile pouch.
16054163|NCT02495753|Procedure|Abdominal Cleansing|The abdomen will be cleansed using chlorhexidine or betadine according to surgeon's preference prior to cesarean.
16054164|NCT02495740|Behavioral|Commuting to work|Commuting by an electric assisted bike to work for a period of 4 weeks at least 3 times per week
16054165|NCT02495727|Behavioral|Step-reduction|Participants will reduce the number of steps they take each day to less than 1, 500 for two weeks, using a pedometer to monitor their daily step count.
16054166|NCT02495727|Behavioral|Pre-training|Participants will attend 10 strength training exercise sessions over a four week period prior to the step-reduction intervention. These exercise sessions will be focused on lower limb strength, fully supervised and will be progressive.
16054167|NCT02495727|Behavioral|Exercise snacking|Participants will perform three bouts of five minutes of exercise each day during the two week step-reduction intervention. These will consist of five discrete exercises, each performed continuously for one minute, with one minute of rest between each exercise. These exercises will be non-supervised, and require no specialist equipment.
16054168|NCT02495714|Behavioral|Active learning|Physical activity one hour a day as part of academic learning
16054169|NCT02495714|Behavioral|Dietary councelling|Teaching children and parents about a healthy diet
16054170|NCT02495701|Procedure|Hip arthroscopic surgery|Hip arthroscopic surgery
16054171|NCT02495688|Procedure|Regional anesthesia|Standard supraclavicular brachial plexus nerve block. Ultrasound-assisted. By an anesthesiologist. A mix of short- and medium lasting local anesthetics will be used.
16054172|NCT02495688|Procedure|General anesthesia|Standard procedure.
16054173|NCT02495675|Device|High flow nasal cannulas|Comparison of different flow levels
16054174|NCT02495675|Device|Conventional flow via nasal prongs|Low flow of air delivered through conventional nasal prongs
16054175|NCT02495662|Drug|PEG-liposomal prednisolone sodium phosphate|Liposomal prednisolone
16054176|NCT02495662|Drug|Placebo|0.9% normal saline
16054177|NCT02495649|Other|[18F]-DOPA|To evaluate the feasibility of PET-CT with [18F]-DOPA to assess the myocardial sympathetic denervation in patients with or suspected with Parkinson's disease
16054178|NCT02495649|Device|PET-CT|To evaluate the feasibility of PET-CT with [18F]-DOPA to assess the myocardial sympathetic denervation in patients with or suspected with Parkinson's disease
16054179|NCT02495636|Drug|CDX-1401|CDX-1401 1mg will be administered intracutaneously every 2 weeks for 4 doses (priming), followed by every 12 week dosing (booster)
16054180|NCT02495636|Drug|MPDL3280A|MPDL3280A 1200 mg will be administered intravenously every 3 weeks.
16054181|NCT02495623|Drug|SYN-010 21 mg|
16054182|NCT02495623|Drug|SYN-010 42 mg|
16054183|NCT02495623|Drug|Placebo|
16054184|NCT02495610|Other|Gait analysis and MRI:|"Gait analysis: Treadmill with pressure sensors (FDM-THM-M-System; 'Zebris' medical GmbH), study-specific, but routine procedures.
~MRI: Performed in a scanner at the University Hospital with standard MRI compatibility procedures; study specific is only the additional MRI after the CSF release with spinal tap or drainage."
16054185|NCT02495597|Other|no intervention - just observational|
16054186|NCT02495584|Dietary Supplement|Fortified milk (10µg vitamin D3)|
16054187|NCT02495584|Dietary Supplement|Unfortified milk (placebo)|
16054188|NCT02495584|Dietary Supplement|10µg vitamin D3 supplement|
16054189|NCT02495584|Dietary Supplement|Placebo supplement|
16054190|NCT02495571|Other|Cough Assessment in ALS Patients|"Volitional Cough assessment by spirometer:
~a) Peak Cough Espiratory Flow (PCEF)
~Cough Reflex Test a) Peak Cough Espiratory Flow (PCEF)"
16054191|NCT02495558|Other|Reflex Cough Test|Peak of Cough Expiratory Flow of the reflex cough
16054192|NCT02495545|Procedure|CSFD and elevation of MAP|Lumbar drain placement with CSFD with elevation of MAP
16054193|NCT02495545|Procedure|Maintenance of MAP|Lumbar drain placement without CSFD and with maintenance of MAP
16054223|NCT02495272|Drug|Oxytocin|Oxytocin 10IU Administered intramuscularly.
16054194|NCT02495532|Other|Lymph node clearing technique with Carnoy solution|"Procedure: lymph node clearing technique with Carnoy solution
~(1) just after the surgical resection each specimen is fixed by formaldehyde; (2) lymph node harvesting is performed by a manual technique of vision and palpation; (3) lymph nodes retrieved are counted, stained with hematoxylin and eosin and examined with light microscopy; (4) the surgical specimen is submitted to re-fixation with Carnoy solution and another lymph node harvesting by manual technique of vision and palpation; (5) additional lymph nodes retrieved are counted, stained with hematoxylin and eosin and examined with light microscopy."
16054195|NCT02495532|Other|Lymph node clearing technique with GEWF solution|"Procedure: lymph node clearing technique with GEWF solution
~(1) just after the surgical resection each specimen is fixed by formaldehyde; (2) lymph node harvesting is performed by a manual technique of vision and palpation; (3) lymph nodes retrieved are counted, stained with hematoxylin and eosin and examined with light microscopy; (4) the surgical specimen is submitted to re-fixation with GEWF solution and another lymph node harvesting by manual technique of vision and palpation; (5) additional lymph nodes retrieved are counted, stained with hematoxylin and eosin and examined with light microscopy."
16054196|NCT02495519|Drug|Imatinib|Imatinib 400 mg/day until disease progression
16054197|NCT02495506|Other|Cold stored platelets|Intervention: Leukoreduced platelet concentrates stored at 4 degrees C for treatment of bleeding after Cardiac surgery. Storage time for RCT platelet concentrates are up to 7 days.
16054198|NCT02495506|Other|Room temperature platelets|Intervention: Leukoreduced platelet concentrates stored at 22 degrees C for treatment of bleeding after Cardiac surgery. Storage time for RCT platelet concentrates are up to 7 days.
16054199|NCT02495493|Drug|Induction DCS chemotherapy|docetaxel /cisplatin/S-1 followed by chemoradiotherapy (S-1/cisplatin)
16054200|NCT02495480|Device|A novel disposable sheath|a new sheath will be placed on the endoscope in sheathed group
16054201|NCT02495467|Drug|Glyceryl trinitrate|At least 4 applications of MED2005 prior to intercourse over a period of 4 weeks
16054202|NCT02495467|Drug|MED Placebo|At least 4 applications of MED2005 prior to intercourse over a period of 4 weeks
16054203|NCT02495454|Drug|Ga101|
16054204|NCT02495441|Other|Use of Rapid Immunoassay Tests for the Detection of PROM|"After informed consent , both the ROM Plus®, ActimProm Amnioquick® Complete and AmniSure® bedside tests (without the use of a speculum) will be performed.
~The patient will then undergo the standard clinical assessment, which includes a sterile speculum exam (SSE). If either 1) amniotic fluid is seen leaking from the cervical os, or 2) if at least two of the following three clinical signs are present: visual pooling of fluid in the posterior fornix, positive nitrazine test, and microscopic evidence of ferning, then the patient will be considered positive for ROM.
~Women who cannot be confirmed clinically by the SSE will undergo an ultrasound evaluation to determine the amniotic fluid index. The patient will be treated according to the results of the SSE and ultrasound, not the results of IGFBP-1/AFP tests and Amnisure®."
16054205|NCT02495428|Procedure|Kinesio Tape Method|
16054206|NCT02495415|Drug|Fenretinide|Fenretinide intravenous emulsion administered as a continuous intravenous infusion for 5 days, once every 3 weeks in relapsed/refractory PTCL patients.
16054207|NCT02495402|Behavioral|Motivational Interviewing|Participants assigned to the experimental condition receive a single 20-30 minute motivational interviewing-based brief intervention for substance use.
16054208|NCT02495389|Drug|Mirabegron|Mirabegron is a medication for the treatment of overactive bladder. It was developed by Astellas Pharma and was approved by the United States Food and Drug Administration (FDA) in July 2012.
16054209|NCT02495376|Behavioral|MBSR|Based primarily on the instruction of mindfulness meditation and yoga, MBSR is a group-based, 8-week program that was developed at the University of Massachusetts Stress Reduction Clinic under the direction of Jon Kabat-Zinn. MBSR is comprised of a structured, developmentally sequenced curriculum that uses a group format to experientially instruct participants in the practice of mindfulness meditation and mindful Hatha yoga. Each session includes different forms of meditation practice, such as cultivating awareness of thoughts, feelings and bodily sensations, and learning to incorporate this awareness during stressful emotional and/or physical life situations.
16054210|NCT02495363|Procedure|PECS Block|"As standard departmental protocol ultrasound guided PECS Block will be performed by identifying the thoracic muscles. Following the identification, the investigator will inject the anesthetic solution which will contain the conventional 25 cc of Bupivacaine 0.25-0.5% .
~The concentration is determined by the upper dose limit to 2 mg / kg 11"
16054211|NCT02495363|Drug|Bupivacaine 0.25-0.5%|"Ultrasound guided PECS Block will be performed by identifying the thoracic muscles. Following the identification, the investigator will inject the anesthetic solution which will contain the conventional 25 cc of Bupivacaine 0.25-0.5% .
~The concentration is determined by the upper dose limit to 2 mg / kg 11"
16054212|NCT02495350|Other|Questionarie|"Parturients will be asked to fill out a labor satisfaction questionnaire detailing initial desire for epidural analgesia, final desire for epidural analgesia, adequacy of pain relief during labor and satisfaction with laborOn the third day postoperatively the parturients will be called and assessed for mood and signs of postpartum depression using Edinborough Postnatal Depression scale validated into Hebrew (10) , and we will assess whether or not they are breastfeeding.
~At 6 weeks we will follow-up to assess breastfeeding duration ,and postpartum depression using the Edinborough Postnatal Depression scale.
~Our comparison will include average pain scores, breast feeding success, and postpartum depression assessment."
16054213|NCT02495337|Other|Tissue Collection|
16054214|NCT02495324|Drug|Placebo|2 weeks of placebo PO daily
16054215|NCT02495324|Drug|Fimasartan|60mg 1 tab PO daily for 2 weeks and 120mg 1 tab PO daily for 4 weeks
16054216|NCT02495324|Drug|Valsartan|80mg 1 tab PO daily for 2 weeks and 160mg 1 tab PO daily for 4 weeks
16054217|NCT02495324|Drug|Olmesartan medoxomil|10mg 1 tab PO daily for 2 weeks and 20mg 1 tab PO daily for 4 weeks
16054218|NCT02495311|Procedure|myomectomy or adenomyomectomy|
16054219|NCT02495298|Procedure|Fascial Manipulation|The Fascial Manipulation was performed by a physiotherapist on the spots indicated by clinician as the most painful ones due to CTS. The selected spots were informed to the physiotherapist after the clinical anamnesis.
16054220|NCT02495298|Procedure|Sham Fascial Manipulation|After the clinical anamnesis, a physiotherapist performed the Fascial Manipulation on different spots, rather than the spots the clinician considered the most painful ones due to CTS.
16054221|NCT02495285|Drug|Gelofusine 4%|
16054222|NCT02495285|Drug|Gelaspan 4%|
16054224|NCT02495259|Device|ZU-bend stylet|Laryngoscopy and intubation after induction of anesthesia will be done using the GlideScope and the ZU-bend stylet. The ZU-bend is a specific shaping technique of the intubating stylet that is closely related to the GlideScope blade curvature. Zu-bend stylet is withdrawn as a part of placement procedure during the DLT advancement. Thereafter, GlideScope is removed and placement of the double-lumen endobronchial tube is verified with capnography and fiberoptic bronchoscopy in the usual manner.
16054225|NCT02495259|Device|GlideScope|Laryngoscopy and intubation after induction of anesthesia will be done using the the GlideScope technique. The GlideScope is a video laryngoscope that provides a real-time view of the airway and tube placement during intubation. GlideScope is removed after DLT is in the trachea, and placement of the double-lumen endobronchial tube is verified with capnography and fiberoptic bronchoscopy in the usual manner.
16054226|NCT02495259|Device|GlideRite stylet|Laryngoscopy and intubation after induction of anesthesia will be done with the GlideScope using the GlideRite stylet. The GlideRite stylet is specifically designed to work with the GlideScope and provides the necessary rigidity and curvature to an otherwise flexible tube. GlideRite stylet is withdrawn as a part of placement procedure during the DLT advancement. Thereafter, GlideScope is removed and placement of the double-lumen endobronchial tube is verified with capnography and fiberoptic bronchoscopy in the usual manner.
16054227|NCT02495259|Device|Macintosh blade|Direct laryngoscopy and intubation after induction of anesthesia will be done with the Macintosh blade and a regular double-lumen endobronchial tube (DLT) stylet. The Macintosh blade is used to facilitate visualization of the larynx during double or single lumen endobronchial tube placement. After intubation the Macintosh laryngoscope is removed and the confirmation of the successful placement of the double-lumen endobronchial tube in done in the standard fashion.
16054228|NCT02495259|Device|Regular Double-lumen endobronchial tube (DLT) Stylet|Direct laryngoscopy and intubation after induction of anesthesia will be done with a regular double-lumen endobronchial tube (DLT) stylet and the Macintosh blade. The DLT stylet is withdrawn as a part of placement procedure during the DLT advancement. Thereafter, Macintosh laryngoscope is removed and placement of the double-lumen endobronchial tube is verified with capnography and fiberoptic bronchoscopy in the usual manner.
16054229|NCT02495246|Biological|ChAd3-EBO-Z|
16054230|NCT02495246|Biological|Ad26.ZEBOV|
16054231|NCT02495233|Drug|Gilteritinib|oral
16054232|NCT02495233|Drug|Erlotinib|oral
16054233|NCT02495220|Drug|SB dexmedetomidine bupivacaine block|SB block with 0.05 mL/kg of 0.5%bupivacaine and 0.5µ/kg dexmedetomidine mixture
16054234|NCT02495220|Drug|intravenous dexmedetomidine|received 1µ/kg IV dexmedetomidine
16054235|NCT02495207|Device|Piezosurgery|This intervention is dependent on use of piezosurgery to conduct the required bone cuts to remove third molars.
16054236|NCT02495194|Behavioral|Horticultural Therapy|The Horticultural Therapy intervention consists of 1 hour sessions weekly for first 3 months, followed by monthly session for the next 3 months. They will be taught on the basic gardening techniques such as sowing, weeding and fertilization during the hands-on sessions. They will also be taken on walks to the various parks to enjoy the therapeutic effect of the park greenery
16054237|NCT02495181|Drug|Intravitreal Aflibercept|
16054238|NCT02495168|Drug|Generic Budesonide/Formoterol Fumarate Dihydrate|Oral inhalation, generic formulation of the brand-name product.
16054239|NCT02495168|Drug|Symbicort® (Budesonide/Formoterol Fumarate Dihydrate)|Oral inhalation, brand-name product.
16054240|NCT02495168|Drug|Placebo|Oral inhalation, no active ingredient.
16054241|NCT02495155|Behavioral|PROSPECT|PROSPECT is an internet-based exercise and behavioral symptom management program developed for patients who experience long-term side effects from cancer treatment. The cancer-specific symptom management intervention is intended as a self-management adjunct to improve cancer- and treatment-related symptoms through non-pharmacologic approaches.
16054242|NCT02495129|Drug|VAY736 lower dose|Patients will receive a total number of 3 monthly subcutaneous injections with the lower dose of VAY736
16054243|NCT02495129|Drug|VAY736 higher dose|Patients will receive a total number of 3 monthly subcutaneous injections with the higher dose of VAY736
16054244|NCT02495103|Drug|Vandetanib|PHASE I: Vandetanib by mouth (PO) daily at 300mg in combination with escalating doses of metformin.
16054245|NCT02495103|Drug|Metformin|Phase I: Metformin starting dose 250mg by mouth (PO) daily in combination with Vandetanib
16054246|NCT02495103|Drug|Vandetanib/Metformin|Phase II: Vandetanib and metformin by mouth (PO) daily at determined maximum tolerated dose (MTD).
16054247|NCT02495090|Genetic|Exome sequencing|Plain DNA sequencing
16054248|NCT02495077|Biological|Infliximab|A single dose, of 3mg/kg infusion
16054249|NCT02495077|Drug|Methylprednisolone|500mg will be Initiated just prior to or at the initiation of transplant surgery and prior to Infliximab and thymoglobulin infusion
16054250|NCT02495077|Drug|Mycophenolate Mofetil|Administered at a target dose of 2000mg daily, as tolerated, until study closure
16054251|NCT02495077|Drug|Tacrolimus|Administered at a target dose of 0.1mg/kg BID, post-op, then adjusted to target trough levels of 8-12ng/ml during 1st 3-months post-op and finally adjusted to target trough levels of 5-8ng/ml until study closure
16054252|NCT02495077|Biological|Thymoglobulin®|Administered daily for 5 days with the intention of achieving a total dose of 4.5 to 6.0 mg/kg, as tolerated
16054253|NCT02495077|Drug|Acetaminophen|"30 to 60 minutes prior to the start of the infusion
~Tylenol, 600 to 1000mg by mouth or
~Suppository form"
16054254|NCT02495077|Drug|Loratadine|"30 to 60 minutes prior to the start of the infusion
~Claritin (Loratadine) 10mg by mouth or
~Benadryl (Diphenhydramine) 25 or 50 mg by mouth"
16054255|NCT02495077|Biological|Placebo for Infliximab|A single dose is volume matched to Infliximab (250mL) infusion
16054256|NCT02495077|Drug|Prednisone|Prednisone will be administered peri-operatively according to center practice. Prednisone should be gradually tapered to no less than 5 mg/day or 10 mg every other day by 3 months post-transplant thereafter until study closure.
16054257|NCT02495077|Drug|Diphenhydramine|"30 to 60 minutes prior to the start of the infusion
~Claritin (Loratadine) 10mg by mouth or
~Benadryl (Diphenhydramine) 25 or 50 mg by mouth"
16054258|NCT02495064|Drug|Mometasone Furoate Cream|One side of patients' neck will begain to use MF cream from the first day of radiation therapy.
16054259|NCT02495051|Procedure|esophageal biopsies|
16054770|NCT02491229|Other|LOGI diet|For twelve weeks, this group eats meals according to the Low Glycemic and Insulinemic Diet (LOGI).
16054260|NCT02495038|Drug|10% reduction of combination of Esmeron® and Nimbex®|Patients were randomly assigned to each group by opening of sealed allocation envelope. After collection of data, allocation number was matched with each group. The participants matched at Group S were administered with NMBAs reduced 10% of each ED95. Before patients arrived in the operating room, rocuronium and cisatracurium were prepared by a nurse who was not involved in this study. Each drug dosage was determined by allocation number. The syringe containing each study drug was conveyed to the performer of this study as the status of shielding the scale. The syringes of rocuronium and cisatracurium used each other syringe.
16054261|NCT02495038|Drug|20% reduction of combination of Esmeron® and Nimbex®|The participants matched at Group L were administered with NMBAs reduced 20% of each ED95.
16054262|NCT02495025|Behavioral|Telephone-based developmental screening and care coordination|
16054263|NCT02495012|Drug|placebo|Freeze-dried powder without snake venom will be dissovled in saline
16054264|NCT02495012|Drug|Anfibatide|Freeze-dried powder with snake venom will be dissovled in saline
16054265|NCT02494999|Biological|13-valent pneumococcal conjugate vaccine|0.5ml vaccine produced by Beijing Minhai Biotechnology Co., Ltd.,three doses with 2 month interval, a booster dose 10 months after the first dose
16054266|NCT02494999|Biological|Prevnar 13|0.5ml vaccine produced by Wyeth,three doses with 2 month interval, a booster dose 10 months after the first dose
16054268|NCT02494973|Drug|Oxaliplatin HAI|Oxaliplatin 85 mg/m² in 2 hours HAI day (D)1,
16054269|NCT02494973|Drug|Oxaliplatin IV|Oxaliplatin 85 mg/m² in 2 hours IV day (D)1,
16054270|NCT02494973|Drug|mFOLFOX6|Acide folinique 400 mg/m² in 2 hours IV (concomitantly to oxaliplatin) D1, followed by 5FU bolus 400 mg/m² in 5-10 minutes IV D1 followed by 5FU 2400 mg/m² IV in 46 hours.
16054271|NCT02494973|Drug|LV5FU2|Acide Folinique 400 mg/m² in 2 hours IV (concomitantly to oxaliplatin) D1, followed by 5FU bolus 400 mg/m² in 5-10 minutes IV D1 followed by 5FU 2400 mg / m² IV in 46 hours.
16054272|NCT02494960|Behavioral|The brief smoking cessation AWARD model|"Ask whether or not the patient currently smokes
~Warn the patients that at least one out of two smokers will be killed by smoking. Recent research shows that two out of three smokers will be killed by smoking. The 10-20-second script could be like 'I warn you that smoking can kill you by many serious diseases and that your chance to be killed prematurely by smoking is about 50% to 67%.
~Advice the patients to quit now or as soon as possible because quitting can reduce the excess risks substantially.
~Refer the patients to a smoking cessation clinic or call telephone quitlines (if available) as soon as possible, emphasizing that smoking cessation counsellors are caring and helpful.
~Do it again: Repeat the intervention among smokers who fail to quit or relapse, and encourage them to try to quit again."
16054273|NCT02494960|Behavioral|Placebo intervention|Advice the smokers to eat vegetables, and engage in regular physical activities, and offer the smokers a card which contains information about the benefits of eating vegetables and a pictorial information leaflet which shows the recommended amount of vegetables and fruits an adult should eat a day
16054274|NCT02494947|Behavioral|high intensity interval-based aerobic exercise|Interval exercises done 3 times weekly during 6 months according to standard procedures at the Department of Circulation and Medical Imaging.
16054275|NCT02494947|Other|Usual care|
16054276|NCT02494934|Behavioral|cognitive-behavioural therapy|The CBT program was adapted from a previously used group CBT program and included the following procedures: (1) education about PVD; (2) collaborative re-conceptualization of PVD as a multi-factorial pain condition; (3) desensitization exercises; (4) diaphragmatic breathing and other relaxation techniques; (5) discussion about and techniques for increasing sexual desire and arousal; (6) sexual communication skills training; (7) instructions on carrying out PFM exercises; (8) instructions on the use of silicone vaginal dilators to do progressive vaginal penetration activities at home; and (9) informal and formal cognitive restructuring techniques and the use of coping self-statements.
16054277|NCT02494934|Behavioral|physical therapy|The PT treatment protocol included the following procedures: (1) education about PVD; (2) targeted PFM exercises focused on contraction and relaxation including in-session practice and feedback; (3) manual techniques; (4) surface electromyographic biofeedback (sEMG); (5) progressive vaginal penetration activities through the use of four silicone vaginal dilators of varied diameter; (6) stretches of the hip muscles; (7) deep breathing and global body relaxation exercises; and (8) additional methods of managing pain and counseling about different sexual positions.
16054278|NCT02494921|Drug|Docetaxel|
16054279|NCT02494921|Drug|Ribociclib|
16054280|NCT02494921|Drug|Prednisone|
16054281|NCT02494921|Drug|Filgrastim|
16054282|NCT02494908|Behavioral|Playing a computer game simulating a car race|Playing a computer game simulating a car race
16054283|NCT02494895|Drug|Ticagrelor monotherapy|Ticagrelor (Brilinta®) is indicated for the prevention of thrombotic events (for example stroke or heart attack) in people with acute coronary syndrome or myocardial infarction with ST elevation. Patients will be randomized to stop aspirin at 3 months after PCI.
16054284|NCT02494895|Drug|Ticagrelor with Aspirin DAPT(dual antiplatelet treatment)|Ticagrelor (Brilinta®) is indicated for the prevention of thrombotic events (for example stroke or heart attack) in people with acute coronary syndrome or myocardial infarction with ST elevation. Patients will be randomized to continue DAPT (aspirin+ticagrelor) up to 1 year.
16054285|NCT02494882|Drug|Ruxolitinib|
16054286|NCT02494882|Drug|Dasatinib|
16054287|NCT02494882|Drug|Dexamethasone|
16054288|NCT02494869|Behavioral|Nonlinear Aerobic Training|
16054289|NCT02494869|Other|Height, Weight, BMI measure|
16054290|NCT02494869|Other|Blood draw|
16054291|NCT02494869|Other|Cardiopulmonary exercise test|
16054292|NCT02494856|Drug|Surgery with Naproxen|After lower third molars surgeries, clinical efficacy of the Naproxen 500mg was study.
16054293|NCT02494856|Drug|Surgery with Naproxen and Esomeprazole|After lower third molars surgeries, clinical efficacy of the Naproxen 500mg and Esomeprazole 20mg was study.
16054294|NCT02494843|Other|online Hemodiafiltration|Effects of high efficiency online hemodiafiltration on cardiac structure, function and myocardial perfusion were compared with standard haemodialysis.
16054885|NCT02490267|Other|Quality of Life questionnaire|
16054295|NCT02494843|Other|Hemodialysis|Effects of high efficiency online hemodiafiltration on cardiac structure, function and myocardial perfusion were compared with standard haemodialysis.
16054296|NCT02494830|Drug|Ketamine|Intravenous infusion of 5 mg ketamine solution, diluted in 240 ml 0.9% saline within 30 min under fasting conditions on study day 1 and oral administration of one prolonged release tablet ketamine together with 240 ml table water under fasting conditions with increased dose (10, 20, 40 and 80 mg) and at least 7 days wash-out between the study days
16054297|NCT02494817|Behavioral|Male Couples Agreement Project|Couples assigned to the intervention group will first as individuals view general video about purpose of study and how to use website functions; timeline activity about their relationship; select top values about their relationship; learn about effective HIV prevention strategies; learn about sexual agreements; select what items they want to have in their agreement; explore a learning module about testing and view the sexual health resource center. As a couple, they will log back into the website to view and compare timelines and relationship values; watch a video about communicating more effectively; negotiate and decide together what items they want to include in their agreement; explore the sexual health resource center and/or any other modules from when they were logged into the website as individuals; download a corresponding smartphone app that will include a copy of their newly created agreement and sexual health resource center.
16054298|NCT02494804|Drug|Temozolomide|Capsules supplied in 5-mg, 20-mg, 100-mg, 140-mg, 180-mg, and 250-mg strengths; dosed at 200 mg/m2/day for 5 consecutive days, repeated every 28 days
16054299|NCT02494804|Biological|CIK|The patients received autologous cytokine-induced killer cells transfusion one week after Temozolomide treat
16054300|NCT02494791|Behavioral|Questionnaire, Educational Material|Participants in this study will be given educational material about Lynch Syndrome and genetic testing for this condition. They will be asked to complete questionnaires about their family cancer history, personal health history and attitudes toward genetic testing.
16054301|NCT02494778|Drug|Pridopidine|45 mg BID
16054302|NCT02494765|Device|I-gel TM|Airway management with I-gel
16054303|NCT02494765|Device|Ambu AuraOnce (AO)|Airway management with Ambu AuraOnce (AO)
16054304|NCT02494752|Procedure|Fat graft enriched with ex vivo expanded stem cells|Fat graft will be enriched with ex vivo expanded stem cells
16054305|NCT02494752|Procedure|Fat graft not enriched with ex vivo expanded stem cells|Fat graft will not be enriched with ex vivo expanded stem cells
16054306|NCT02494739|Other|Yogurt enriched with polyphenols|Yogurt enriched with polyphenols extracted from grape seeds
16054307|NCT02494739|Other|Yogurt not enriched with polyphenols|Yogurt not enriched with polyphenols
16054308|NCT02494726|Other|Thromboelastography|TEG (Thrombelastography) measurements include: Split Point (SP) is the time elapsed for the clot to initially form fibrin when the blood is first placed in the TEG machine. Reaction Time (R) is the time elapsed from its initial fibrin formation until the clot reaches 2mm. K is the time measured from R until the level of clot firmness reaches 20mm, measuring the speed of clot strengthening. These are measured in minutes. Delta measures if the formation of the clot has been suppressed; measured as the difference between R and SP. Angle reflects the speed at which clots form by forming the slope of the TEG tracing at R from the horizontal line. Maximum Amplitude (MA) in mm is the measure of maximum strength of the clot, true platelet function. G is the measure of the clot firmness; measured by a formula (G=(5000*MA)/(100-MA) in dynes/cm2). LY30 is a measure of clot lysis at 30 minutes after MA is reached.
16054309|NCT02494713|Drug|Degarelix|Subcutaneous injection, once/month for 4 months
16054310|NCT02494713|Drug|Doxorubicin|20 mg/m2 as a 24-hour intravenous infusion on day 1 each week, weeks 1, 3, and 5
16054311|NCT02494713|Drug|Ketoconazole|400 mg orally 3 times daily for 7 days, in weeks 1, 3, and 5
16054312|NCT02494713|Drug|Docetaxel|35 mg/m2 intravenously on day 1 of each week, weeks 2, 4, and 6
16054313|NCT02494713|Drug|Estramustine|280 mg orally 3 times daily for 7 days, in weeks 2, 4, and 6
16054314|NCT02494700|Radiation|External Beam Radiation Therapy|Undergo orbital EBRT
16054315|NCT02494700|Drug|Orbital Radiation|Participants receive radiation to entire involved orbit for a total dose of 4 Gy in 2 fractions over two consecutive days with external beam radiotherapy. If there is stable disease or progressive disease, an additional 20 Gy administered to involved site. If there are two consecutive evaluations with no change in disease burden then an additional 20 Gy administered. At one year if there is persistent disease, an additional 20 Gy administered to involved site.
16054316|NCT02494687|Drug|Oral Domperidone|10 mg of oral domperidone administered (four times a day) for two weeks
16054317|NCT02494687|Drug|Oral Domperidone|Increased to 20 mg four times a day for 2 weeks at the Investigator's discretion
16054318|NCT02494687|Drug|Oral Domperidone|Increased to 30 mg four times a day at the Investigator's discretion
16054319|NCT02494674|Behavioral|Bite Counter tracking|Participants will be asked to use the bite counter to track all meals and provide feedback on using the bite counter for dietary self-monitoring.
16054320|NCT02494661|Behavioral|Healthy Cart and Stress Management Videos|Healthy Cart and Stress Management Videos: educational videos on healthy food shopping and stress reduction.
16054321|NCT02494661|Behavioral|Healthy Cart Video|Healthy Cart Video: educational video on healthy food shopping
16054322|NCT02494648|Device|POWERbreathe Fitness Plus, (POWERbreathe International Ltd, UK) [Inspiratory muscles strengthening]|CAD patients participated in a 6-week (20 sessions of training) resistive inspiratory muscle training (RIMT) program for 10 minutes twice daily at a training intensity of 70% of maximum inspiratory pressure (MIP).
16054323|NCT02494648|Other|Control|
16054324|NCT02494635|Other|Laboratory Biomarker Analysis|Biomarker analysis
16054325|NCT02494609|Drug|sotagliflozin|400 mg sotagliflozin
16054326|NCT02494609|Drug|oral contraceptive|0.25 mg norgestimate/0.035 mg ethinyl estradiol
16054327|NCT02494609|Drug|oral contraceptive + sotagliflozin|0.25 mg norgestimate/0.035 mg ethinyl estradiol + 400 mg sotagliflozin
16054328|NCT02494596|Drug|Capecitabine|Participants will receive capecitabine on Days 1 to 14 of each 3-week cycle as 825, 1000, or 1250 mg/m^2 PO twice daily. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal.
16054329|NCT02494596|Drug|RhuMab 2C4|Participants will receive rhuMab 2C4 on Day 1 of each 3-week cycle as 1050 mg via IV infusion. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal.
16054886|NCT02490254|Other|Surveillance card|
16054330|NCT02494583|Biological|Pembrolizumab|Pembrolizumab 200 mg IV on Day 1 of each week in 3-week cycles for up to 35 cycles (approximately 2 years).
16054331|NCT02494583|Drug|Cisplatin|Cisplatin 80 mg/m^2 IV on Day 1 of each week in 3-week cycles (6 cycle maximum per local country guidelines).
16054332|NCT02494583|Drug|5-FU|5-FU 800 mg/m^2/day IV continuous from Day 1-5 of each 3-week cycle.
16054333|NCT02494583|Drug|Capecitabine|Capecitabine 1000 mg/m^2 twice daily by oral tablet on Day 1-14 of each 3-week cycle.
16054334|NCT02494583|Drug|Placebo|Normal saline IV on Day 1 of each week in 3-week cycles for up to 35 cycles (approximately 2 years).
16054335|NCT02494570|Drug|ABI-009|
16054336|NCT02494544|Device|Off the Shelf Total Knee Replacement|A knee replacement system by DePuy, Zimmer, Biomet, Smith & Nephew, or Stryker
16054337|NCT02494544|Device|ConforMIS iTotal Knee Replacement|A knee replacement performed with patient specific implant and surgical jigs.
16054338|NCT02494531|Radiation|Fluorodeoxyglucose-PET|Fluorodeoxyglucose-PET performed within 2 months
16054339|NCT02494531|Radiation|florbetapir F 18-PET|florbetapir F 18-PET performed within 2 months
16054340|NCT02494518|Behavioral|Forced Exercise & Upper Extremity Repetitive Task Practice|
16054341|NCT02494518|Behavioral|Voluntary Exercise & Upper Extremity Repetitive Task Practice|
16054342|NCT02494518|Behavioral|Stroke Education & Upper Extremity Repetitive Task Practice|
16054343|NCT02494505|Drug|Mycophenolate Mofetil|2g/day per os
16054344|NCT02494505|Drug|placebo|
16054345|NCT02494492|Other|intravitreous administration of regulator T-cells|The 3 levels of Tregs doses will be respectively 0.4, 1.2 and 3.6 million.
16054346|NCT02494479|Drug|Prurisol|50mg tablet
16054347|NCT02494479|Drug|Placebo|Sugar pill designed to match Purisol tablet
16054348|NCT02494466|Drug|montelukast sodium|4 mg peroral Montelukast Sodium, 10 days before surgery because of high IgE.
16054349|NCT02494453|Procedure|Research Cardiac MRI|Cardiac MRI has increasing utility in evaluating structural and functional cardiac pathologies. For detection of coronary artery disease, MRI outperforms SPECT and dobutamine stress echocardiography for the detection of ischemia. MRI also can detect wall-motion abnormalities and other dysfunction. Dynamic contrast-enhanced MRI (DCE-MRI) can evaluate microvascular parameters such as vessel permeability and fluid volume fraction as an assessment of tissue perfusion. Thus, cardiac MRI holds promise for early detection of subclinical cardiac abnormalities after radiotherapy and could potentially identify patients for intervention to prevent cardiac events. All patients will follow the protocol calendar requiring research MRIs, but will receive standard radiation treatment determined by their treating physician. In this study, treatment will not be altered based on the data collected from these MRIs.
16054350|NCT02494453|Procedure|Biomarkers|"Scant data exist on potential biomarkers of cardiac radiation exposure and damage. However, we have identified potential candidates based on other processes affecting heart function in a way similar to probable mechanisms of RT-related injury. For fibrosis and left ventricular dysfunction, these include galectin-3 and N-terminal-Pro brain natriuretic peptide. For myocyte destruction, troponin; for inflammation and oxidative stress, C-reactive protein, myeloperoxidase, and growth differentiation factor 15. Additional blood will be collected and stored for future assessment of other candidate biomarkers.
~All patients will follow the calendar of protocol required research blood draws for biomarker collection, but will receive standard radiation treatment as clinically indicated by their treating physician. In this study, treatment will not be altered based upon the data collected from these samples."
16054351|NCT02494427|Device|CAD/CAM manufactured fixed unitary dental prostheses|
16054352|NCT02494427|Device|Conventionally manufactured unitary dental prostheses|
16054353|NCT02494414|Other|Long-term follow-up|Vital and neurological follow-up
16054354|NCT02494401|Other|Internet-based self-management program|
16054355|NCT02494401|Other|Scleroderma book|
16054356|NCT02494388|Procedure|Endoscopic ultrasound guided needle based confocal endomicroscopy|Needle based confocal laser endomicroscopy is a technique that enables in vivo microscopic analysis during ongoing endoscopy. It has good accuracy for predicting the final histopathological diagnosis based on immediate evaluation of tissue and vascular patterns. nCLE microprobe is a flexible probe thin enough that it can be passed through a 19-gauge needle. Thus under EUS guidance solid organs (i.e. the pancreas) can be accessed for real-time microscopic information.
16054357|NCT02494375|Other|Sleep and glucose assessments|Sleep characteristics, glycemic control, salivary amylase and body composition will be assessed 3 times, at 3-4 months intervals
16054358|NCT02494362|Other|Computer gaming hand exercise regimen.|Computer gaming hand exercise regimen using common objects of daily life. The hand exercises are coupled with commercially available computer games and will be performed 30 minutes,four times per week for 12 weeks.
16054359|NCT02494349|Drug|JLP-1207|The subjects will receive JLP-1207 under fed(high fat meal) condition. After washout period, the subjects will receive Solifenacin 5mg and Tamsulosin 0.2mg under fed(high fat meal) condition.
16054360|NCT02494349|Drug|Solifenacin 5mg+Tamsulosin 0.2mg|The subjects will receive Solifenacin 5mg and Tamsulosin 0.2mg under fed(high fat meal) condition. After washout period, the subjects will receive JLP-1207 under fed(high fat meal) condition.
16054361|NCT02494336|Procedure|Trans-incisional rectus sheath block|After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon. This will be done after closure of the fascial incision but prior to closure of the skin incision.
16054362|NCT02494336|Procedure|Laparoscopic guided rectus sheath block|After removal of the gallbladder, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally) will be administered intra-abdominally under direct laparoscopic visualization into the rectus sheath bilaterally by the attending surgeon.
16054363|NCT02494336|Drug|Ropivacaine|Ropivacaine is a long-acting local anesthetic. It has been shown to be effective for peripheral nerve, caudal, and lumbar/thoracic epidural blocks and produce less motor blockade than bupivacaine after caudal administration. It will be the local anesthetic used to perform the rectus sheath block for both arms.
16054364|NCT02494323|Device|Functional Electrical Stimulation|Single channel and dual channel FES for balanced dorsiflexion for patients with dropfoot
16055036|NCT02489240|Drug|vitamin D3 tablets|2000 IU vitamin D3 tablets were taken daily for 6 days
16054365|NCT02494310|Device|High-Resolution Microendoscopy Imaging|Innovative technique to evaluate epithelial cell morphology in situ. The device is not invasive and does not exchange energy with human body.
16054366|NCT02494284|Drug|Clopidogrel|6-month DAPT followed by clopidogrel monotherapy
16054367|NCT02494284|Drug|Aspirin plus clopidogrel|standard long-term dual antiplatelet strategies (24-month DAPT followed by aspirin monotherapy)
16054368|NCT02494258|Drug|CC-486|The subject will continue at the same dose, frequency and schedule used for the last dose of CC-486 given in the preceding CC-486 study. Subjects are allowed to rollover after the last cycle is finished and before the new cycle begins in the parent protocol. There is a 7 day window from End of Study on the parent protocol and when the participant will start Day 1 of the rollover study.
16054369|NCT02494245|Other|STARFISH|The intervention group will take part in a four month physical activity intervention using the STARFISH app with the aim of increasing physical activity by 3000 steps per day. Participants will be provided with a smartphone for the intervention. Participants will work in groups of four but each participant will have their own individualised step count target, based on their baseline step count. If the participant reaches their step count target on at least five days of the week, then their target will be increased by 5% for the following week, up to a maximum increase of 3000 steps above baseline. Where a participant fails to reach their step count target, it remains unchanged for the following week.
16054370|NCT02494219|Procedure|Rapid Immunochromatographic streptococcal test|Throat swab obtained for rapid strep test in addition to throat culture,in order to check the accuracy of Rapid Immunochromatographic streptococcal test in detection of streptococcal pharyngitis
16054371|NCT02494206|Drug|QBX258|Once patients are registered for the trial, they will be treated with QBX258 (VAK694 3mg/kg and QAX576 6mg/kg) delivered via peripheral intravenous injection once every 4 weeks (+ 1 week) for 4 treatments.
16054372|NCT02494193|Other|Partial caries removal|The caries infected dentin will be removed mantaining the affected caries tissue.
16054373|NCT02494193|Other|Provisional restoration - control|After partial caries removal, a provisional restoration will be performed using a layer of calcium hydroxide paste covered by a layer of calcium hydroxide cement and resin-modified glass ionomer.
16054374|NCT02494193|Other|Provisional restoration - experimental|After partial caries removal, a provisional restoration will be performed using only resin-modified glass ionomer.
16054375|NCT02494193|Other|Total caries removal|After two months of their placement, the provisional restoration will removed followed by tota caries tissue removal.
16054376|NCT02494193|Other|Definitive restoration|Definite restoration will be performed using composite.
16054377|NCT02494180|Drug|fentanyl|arm A receiving iv fentanyl
16054378|NCT02494180|Drug|pethidine|arm B receiving iv pethidine
16054379|NCT02494180|Drug|Diazepam|arm B receiving iv diazepam
16054380|NCT02494180|Drug|Midazolam|arm A receiving iv midazolam
16054381|NCT02494167|Biological|MultiTAA-specific T cells|"The 5 dose levels are:
~Dose Level 1: 5 x 10e6 cells/m2; Dose Level 2: 1 x 10e7 cells/m2; Dose Level 3: 2 x 10e7 cells/m2; Dose Level Four: 5 x 107 cells/m2; Dose Level Five: 1 x 108 cells/m2
~The T cells are given from 30 days post-HSCT. They are administered by intravenous injection over 1-10 minutes through either a peripheral or central lie.
~If patients with residual disease (Group B) have a partial response, complete response or stable disease, they will be eligible to receive up to 6 further doses of multiTAA-specific T cells at the same dose as the initial infusions (or below the patient's original dose can be administered) at least 4 weeks apart."
16054382|NCT02494154|Device|Airvo 2; Ficher and Paykel HealthCare|High flow nasal cannulas
16054383|NCT02494154|Device|Oxygen delivery via conventional nasal mask|Low flow of oxygen delivered through conventional nasal prongs
16054384|NCT02494141|Drug|Curcumin|Dietary Supplement
16054385|NCT02494141|Other|Placebo|
16054386|NCT02494128|Other|Education|Education in group leadership
16054387|NCT02494115|Procedure|subcutaneous drainage|
16054388|NCT02494102|Drug|Modafinil|Atypical Psychomotor stimulant
16054389|NCT02494102|Drug|Placebo|
16054390|NCT02494089|Other|distress analysis|
16054391|NCT02494076|Drug|EzPAP|
16054392|NCT02494076|Other|Standard Care|
16054393|NCT02494063|Procedure|Sentinel lymph node biopsy|Bilateral sentinel lymph node biopsy, pathologic ultrastaging
16054394|NCT02494063|Procedure|At least unilateral systematic pelvic lymph node dissection|
16054395|NCT02494050|Behavioral|Behavioral Activation-Full|Behavioral Activation proposes that symptom reduction occurs via monitoring daily activities to identify patterns of low reward and mood, assessing and assigning tasks that generate pleasure and competence, understanding and reducing unproductive avoidance, and improving skill deficits to promote action towards treatment goals.
16054396|NCT02494050|Behavioral|Behavioral Activation-Short|Behavioral Activation proposes that symptom reduction occurs via monitoring daily activities to identify patterns of low reward and mood, assessing and assigning tasks that generate pleasure and competence, understanding and reducing unproductive avoidance, and improving skill deficits to promote action towards treatment goals.
16054397|NCT02494050|Behavioral|Bipolar Disorder Collaborative Care|This manualized treatment focuses on social support and educating patients about medication compliance. The primary focus is to strengthen the patients' self-management skills with education; supporting the clinician's decision making using practice guidelines; enhancing access to care, continuity of care, and information flow through the use of the clinician.
16054398|NCT02494024|Drug|Single dose C2N-8E12|C2N-8E12 is a humanized recombinant anti-human tau antibody.
16054399|NCT02494024|Drug|Single dose placebo|Subjects will be block randomized to receive a single dose of C2N-8E12 or placebo in two blocks of 4 subjects (3:1, C2N-8E12:placebo) per cohort.
16054400|NCT02494011|Other|traditional exercise|mobilization stretching exercise
16054401|NCT02494011|Other|Russian current stimulation|stimulation to wrist flexors for 15 minutes
16054402|NCT02494011|Other|closed kinetic chain exercise|wall press exercise plyometric exercise
16054403|NCT02493985|Other|0.5% CO2|The subjects will be randomized to breath 0.5% carbon dioxide during one of the -12 degree head down tilt body position periods in crossover design
16054404|NCT02493985|Other|ambient air|The subjects will be randomized to breath ambient air during one of the -12 degree head down tilt body position periods in crossover design
16054405|NCT02493972|Procedure|GelPort|Manual exploration of the peritoneal carcinosis by the system GelPort ® with calculation of peritoneal cancer index for evaluation of the resectability
16054406|NCT02493972|Procedure|laparotomy|laparotomy will be performed if indication confirmed by manual exploration
16054407|NCT02493959|Biological|PYY1-36 infusion|Infusion of 1.6 pmol/kg/min PYY1-36 for 2 hrs.
16054408|NCT02493959|Biological|PYY1-36 + sitagliptin|Infusion of 1.6 pmol/kg/min PYY1-36 for 2 hrs. Two doses of 100 mg sitagliptin are administered 10 and 1 hour before start of infusion, respectively.
16054409|NCT02493959|Biological|PYY3-36 infusion|0.8 pmol/kg/min infusion of PYY3-36.
16054410|NCT02493959|Biological|placebo|Infusion of saline for 2 hrs.
16054411|NCT02493946|Biological|Botulinum toxin type A|
16054412|NCT02493946|Drug|Placebo|
16054413|NCT02493933|Drug|Phytoestrogens, Isosorbid mononitrate, N-acetyl cysteine|
16054414|NCT02493920|Other|Sustained lung inflation|Sustained lung inflation (SLI) will be performed with mask using a T-piece system (Fabian,Acutronic Medical Systems AG, Switzerland).Peak inflation pressure (PIP) of 25 cm H2O will be delivered for 15 seconds and then reduced to a PEEP of 5 cm H2O. A second SLI manoeuvre will be repeated in case of persistent hearth failure (HR <100 bpm).
16054415|NCT02493920|Device|mask using a T-piece system (Fabian,Acutronic Medical Systems AG, Switzerland).|
16054416|NCT02493894|Drug|PEG|PEG solution (80gr/1Litr) each 8 hours for 24 hours
16054417|NCT02493894|Drug|placebo|placebo each 8 hours for 24 hours
16054418|NCT02493894|Drug|Cefazolin|cefazolin 1gram, every 6hours for 2 days
16054419|NCT02493881|Device|intraoperative neuromonitoring|NIM-Response 3.0 Intraoperative Neuromonitoring System (Medtronic Xomed, Jacksonville, FL, USA) was used to record the EMG amplitude signal for the anterior and/or posterior branches of recurrent laryngeal nerves (RLNs).
16054420|NCT02493868|Drug|Esketamine|Open-label induction phase: Direct entry participants start at a dose of 56 mg on Day 1. On Day 4, the dose may be increased to 84 mg or remain at 56 mg. From Day 8 to 22, dose may be increased to 84 mg, remain the same or be reduced to 56 mg from 84 mg per protocol, at investigator's discretion based on efficacy and/or tolerability. On Day 25, a dose reduction from 84 mg to 56 mg is permitted but no dose increase is permitted. Optimization Phase: Direct-entry and transferred-entry participants will self-administer intranasal esketamine (same dose) for first 4 weeks, then individualized to either once weekly or once every other week based on depressive symptoms. Maintenance Phase: All participants assigned to esketamine will self-administer intranasal esketamine once weekly or once every other week based on depressive symptoms.
16054421|NCT02493868|Drug|Placebo|Optimization Phase: Transferred-entry participant will self-administer intranasal placebo at weekly treatment sessions for the first 4 weeks of this phase, then individualized to either once weekly or once every other week based on depressive symptoms. Maintenance Phase: Direct-entry and transferred-entry participants assigned to placebo will self-administer matching intranasal placebo once weekly or once based on depressive symptoms.
16054422|NCT02493868|Drug|Duloxetine (Oral Antidepressant)|Duloxetine could be selected as the oral antidepressant medication by the investigator based on review of Massachusetts General Hospital - Antidepressant Treatment Response Questionnaire (MGH-ATRQ) and relevant prior antidepressant medication information. The minimum therapeutic dose is 60 milligram per day (mg/day).
16054423|NCT02493868|Drug|Escitalopram (Oral antidepressant)|Escitalopram could be selected as the oral antidepressant medication by the investigator based on review of MGH-ATRQ and relevant prior antidepressant medication information. Escitalopram will be titrated upto a maximum dose of 20 mg/day, but if not tolerated the dose can be reduced to the minimum therapeutic dose of 10 mg/day.
16054424|NCT02493868|Drug|Sertraline (Oral Antidepressant)|Sertraline could be selected as the oral antidepressant medication by the investigator based on review of MGH-ATRQ and relevant prior antidepressant medication information. Sertraline will be titrated upto a maximum dose of 200 mg/day, but if not tolerated the dose can be reduced to the minimum therapeutic dose of 50 mg/day.
16054425|NCT02493868|Drug|Venlafaxine Extended Release (XR) (Oral Antidepressant)|Venlafaxine Extended Release could be selected as the oral antidepressant medication by the investigator based on review of MGH-ATRQ and relevant prior antidepressant medication information. Venlafaxine Extended Release will be titrated upto a maximum dose of 225 mg/day, but if not tolerated the dose can be reduced to the minimum therapeutic dose of 150 mg/day.
16054426|NCT02493855|Drug|Ombitasvir/ABT-450/Ritonavir|Ombitasvir/ABT-450/ritonavir combination tablets
16054427|NCT02493855|Drug|Dasabuvir|Dasabuvir tablets
16054428|NCT02493855|Drug|Ribavirin (RBV)|Ribavirin tablets
16054429|NCT02493842|Device|Transverse Intrafasicular Multichannel electrode (TIME)|Peripheral nerve stimulation is conducted with Transverse Intrafasicular Multichannel electrode (TIME) version 4 electrodes to induce sensory sensations from the phantom hand, while subject is virtualizing a movement or event which may cause the specific sensation.
16054430|NCT02493829|Biological|AML Cell Vaccine|
16054431|NCT02493816|Drug|Gene-modified autologous fibroblasts|3 intradermal injections of COL7A1 gene-modified autologous fibroblasts will be administered on day 0 only.
16054432|NCT02493803|Behavioral|Dietary Advice|Detailed dietary advice and planning, complete with dietary information sheets which were developed with a dietitian and a dental psychologist
16054433|NCT02493790|Other|Cognitive and motor performances|
16054434|NCT02493777|Drug|HLD200 methylphenidate hydrochloride (MPH) Capsules|HLD200 doses: 20, 40, 60, 80 or 100 mg
16054435|NCT02493777|Drug|Placebo|
16054436|NCT02493764|Drug|Imipenem|Imipenem 500 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days
16054437|NCT02493764|Drug|Relebactam|Relebactam 250 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days
16054438|NCT02493764|Drug|Cilastatin|Cilastatin 500 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days
16054439|NCT02493764|Drug|Piperacillin|Piperacillin 4000 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days
16054440|NCT02493764|Drug|Tazobactam|Tazobactam 500 mg as part of a FDC administered by IV every 6 hours for a minimum of 7 days, up to 14 days
16054441|NCT02493764|Drug|Linezolid|Linezolid 600 mg administered open-label by IV every 12 hours for up to 14 days
16054442|NCT02493751|Drug|Avelumab (MSB0010718C)|Avelumab with two dose levels: 10 mg/kg IV and 5 mg/kg IV every two weeks to find the maximum tolerated dose in combination with axitinib and continue treatment in a dose expansion.
16054443|NCT02493751|Drug|Axitinib (AG-013736)|Axitinib with two dose levels: 5 mg and 3 mg oral BID to find the maximum tolerated dose in combination with avelumab and continue treatment in a dose expansion.
16054444|NCT02493738|Drug|Lozanoc 50mg|Lozanoc 50mg single dose under fed and fasted condition
16054445|NCT02493738|Drug|Sporanox 100mg|Sporanox 100mg single dose under fed condition
16054446|NCT02493725|Drug|Eculizumab|
16054447|NCT02493725|Drug|Placebo|
16054451|NCT02493699|Other|physical exercise- based intervention (Karate techniques training)|
16054452|NCT02493686|Diagnostic Test|audiogram|hearing test
16054453|NCT02493673|Device|Continuous positive airway pressure device|(ResMed Spirit S8)
16054454|NCT02493660|Device|InSpace sub-acromial tissue spacer system|Arthroscopic implantation of InSpace sub-acromial tissue spacer system
16054455|NCT02493660|Procedure|Partial repair of rotator cuff|Arthroscopic partial repair of rotator cuff
16054456|NCT02493647|Behavioral|Love, Sex, & Choices|Investigators propose to conduct a two-arm clinical trial of guide enhanced LSC impact on reducing unprotected sex with high risk partners and increasing HIV testing in Black women in high HIV prevalence neighborhoods. Undiagnosed HIV is a significant factor fueling the epidemic. Recruitment into the study will be via Facebook or traditional on the ground.
16054457|NCT02493634|Procedure|pressure gradient measurement|A guidewire is used to introduce and position a pressure catheter under magnetic resonance guidance to conduct flow and pressure measurement in the aortic arch to evaluate vascular resistance.
16054458|NCT02493634|Device|MRWire|
16054459|NCT02493608|Device|scalpel|used to cut the abdominal wall.
16054460|NCT02493608|Device|Diathermy|Diathermy used to cut , coagulate the tissue
16054461|NCT02493582|Biological|Cytokine-Induced Killer Cells|CIKs are used with Apatinib to treat lung adenocarcinoma patients with wild-type EGFR
16054462|NCT02493582|Drug|Apatinib|Advanced lung adenocarcinoma patients with wild-type EGFR take Apatinib 850mg qd by mouth.
16054463|NCT02493569|Procedure|The radical mastectomy of breast cancer|The radical mastectomy of breast cancer could be used for the treatment of breast cancer during the observation.
16054464|NCT02493556|Device|LLLT before muscle damage|
16054465|NCT02493556|Device|Placebo LLLT before muscle damage|
16054466|NCT02493556|Device|LLLT after muscle damage|
16054467|NCT02493556|Device|Placebo LLLT after muscle damage|
16054468|NCT02493543|Other|Blood collection|Blood collection from the subject's arm
16054469|NCT02493530|Drug|TGR-1202|"Stage 1 will include myelofibrosis or hydroxyurea-resistant/refractory PV patients already taking therapeutic levels of ruxolitinib, but who are not achieving maximal response at highest tolerated dose of ruxolitinib.
~Stage 2 will include myelofibrosis or hydroxyurea-resistant/refractory PV patients who have never been on JAK-STAT inhibitory agents, and includes simultaneously initiation of both ruxolitinib and TGR-1202. TGR-1202 will be administered at or below the recommended dose established in Stage 1.
~Expansion will commence after proper combination doses of both agents is established."
16054470|NCT02493530|Drug|ruxolitinib|
16054471|NCT02493517|Drug|Lanreotide Autogel®|Lanreotide Autogel 60mg, 90mg, and 120mg, pre-filled syringe, deep subcutaneous injection (provided as a supersaturated solution of lanreotide acetate).
16054472|NCT02493517|Drug|Lanreotide Acetate|Lanreotide PR 40mg white freeze-drying cake, 40mg/vial, deep subcutaneous injection (provided as a sterile injectable lyophilisate of lanreotide acetate).
16054473|NCT02493504|Drug|Heparin|100units/kg of heparin were administered for the case group after dissection prior to anastomosis.
16054474|NCT02493465|Drug|Everolimus|Conversion from azathioprine to everolimus in kidneys transplant recipients with left ventricular hypertrophy.
16054475|NCT02493452|Drug|Plecanatide|
16054476|NCT02493452|Drug|Placebo|
16054477|NCT02493439|Behavioral|Best Possible Self|
16054478|NCT02493439|Behavioral|Daily Activities|
16054479|NCT02493426|Drug|Intranasal Oxytocin|
16054480|NCT02493426|Drug|Placebo|
16054481|NCT02493400|Other|No intervention in the follow up study.|
16054482|NCT02493387|Other|Exercise|The group-based exercise program consists of 60-minute sessions twice a week for 3 months, including central circulatory exercise performed on an ergometer cycle and muscle training, and one or two occasions of home-based exercise. The exercise program are designed after the patients requirements and with the intensity 13-17 on the Borg RPE 6-20 scale
16054483|NCT02493387|Other|Physical activity|The patients randomized PAP will receive a PAP prescription and a physical activity diary. The PAP and physical activity diary will be followed up at 6 and 12 weeks after the inclusion.
16054484|NCT02493361|Drug|Pembrolizumab|
16054485|NCT02493361|Drug|pIL-12|
16054486|NCT02493348|Device|Rhythmic Sensory Stimulation|Rhythmic Sensory Stimulation (RSS) can be delivered through sound devices. In this study, the stimuli will be delivered with a portable consumer device called Sound Oasis Vibroacoustic Therapy System (VTS) 1000 unit, which is a low-voltage consumer product device that has two built-in mid to high-frequency speakers and one built in low frequency (subwoofer-type) speaker. The low frequency sounds played by the subwoofer speaker is experienced as vibrotactile vibration. Although the Intervention of Interest in this study is the gamma-frequency acoustic-driven rhythmic sensory stimulation, the efficacy of the Sound Oasis VTS-1000 device to deliver this sound will also be observed.
16054487|NCT02493335|Drug|Budesonide 0.5mg orodispersible tablet twice daily|
16054488|NCT02493335|Drug|Budesonide 1mg orodispersible tablet twice daily|
16054489|NCT02493335|Drug|Placebo orodispersible tablet twice daily|
16054490|NCT02493322|Drug|Olmesartan Medoxomil 20mg + Chlorthalidone 12,5mg|1 tablet a day
16054491|NCT02493322|Drug|Olmesartan medoxomil 20mg + Chlortalidone 25mg|1 tablet a day
16054492|NCT02493322|Drug|Olmesartan 20mg + hydrochlorothiazide 12,5mg|1 tablet a day
16054673|NCT02491944|Drug|AZD9291|Single oral dose of 80 mg AZD9291 tablet on Day 1 administered orally with 240 mL water following an overnight fast.
16054493|NCT02493309|Other|Prolonged sitting|Condition A is referred to as the 'sitting' condition. Here participants will remain seated throughout the whole of the 7 ½ hour test period (8am - 3:30pm). On arrival, participants will have a cannula (a small tube that allows us to take blood) inserted into their arm; this will stay in the arm and allow us to take regular blood samples throughout the day. Blood samples and blood pressure will be taken at 30, 60, 120 and 180 minutes after breakfast. We will then provide a lunch meal and will continue taking blood samples and blood pressure at 30, 60, 120, 180 and 210 minutes after this lunch meal. In total, we will take 11 blood samples over the 7 ½ hour testing period.
16054494|NCT02493309|Other|Light activity breaks|Condition B is the 'light activity breaks' condition. Participants will go through exactly the same process as condition A but will also be asked to do 5 minute bouts of slow walking on a treadmill every 30 minutes following breakfast and lunch. In total they will do 12 five minute walks on the treadmill throughout the 7 ½ hour test period (60 minutes of walking in total). In total, we will take 11 blood samples on the day.
16054495|NCT02493296|Other|This observational study will not entail an intervention.|This study will entail measurement of central aortic haemodynamics before and after (clinically indicated) abdominal aortic aneurysm repair
16054496|NCT02493283|Drug|Dapsone single dose|Administration of two tablets Dapson-Fatol 50 mg Tabletten (= 100 mg dapsone) and sampling of blood (before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 h after single-dose administration), urine (0-24 h, 24-48 h, 48-72 h, 72-96 h, 96 -120 h) and feces (on treatment days 1-5)
16054497|NCT02493283|Drug|Dapsone multiple dose|Administration of two tablets Dapson-Fatol 50 mg Tabletten (= 100 mg dapsone) s.i.d. for 7 days and sampling of blood (before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 h after last repeated-dose administration), urine (last treatment day 0-24 h) and feces (on treatment days 12-15)
16054498|NCT02493283|Biological|leucocytes|sampling for leucocytes collection: study days -1, 1, 14 and 15
16054499|NCT02493283|Biological|Met-Hb|sampling before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 h after single-dose administration, before and 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72 and 96 h after last repeated-dose administration and sampling for additional safety analyses (Met-Hb): study days 10, 12, 14 and hematology on study day 12
16054500|NCT02493270|Behavioral|Smoking cessation therapy|Multidisciplinary smoking cessation therapy, performed by a team comprising physicians, nurses, a psychologist and dentists. It consisted of four 1-h counselling lectures, psychologist-assisted cognitive behavioural therapy, nicotine replacement therapy and medication (bupropion or varenicline). Smoking cessation motivation was reinforced by dentists at the maintenance sessions, by means of motivational interviewing techniques
16054501|NCT02493270|Procedure|Non-surgical periodontal therapy|full-mouth supra and subgingival scaling and root planing (with curettes and ultrasonic scaler); oral hygiene instruction and motivation and removal of intra-oral plaque retentive factors
16054502|NCT02493257|Drug|Capsaicin|
16054503|NCT02493257|Drug|Placebo|
16054504|NCT02493244|Other|Cliradex|Cliradex is simply water and 4-Terpineol, a natural organic compound found Melaleuca alternifolia. The other ingredients in Cliradex are in less than 1% of the formulation and are Glycerin, Polysorbate 20, Polysorbate 80, Carbomer, Triethanolamine.
16054505|NCT02493231|Drug|Nefopam|
16054506|NCT02493231|Drug|Ketamine|
16054507|NCT02493231|Drug|Saline|
16054508|NCT02493218|Behavioral|Mindfulness Instruction|Age-appropriate instruction on mindfulness concepts and practices, adapted from the mindfulness-based stress reduction (MBSR) program. Classes are 45-90 minutes each and held weekly for 12 weeks.
16054509|NCT02493218|Behavioral|Health Education|Age-appropriate health education concepts and topics. Classes are 45-90 minutes each and held weekly for 12 weeks.
16054510|NCT02493192|Drug|pethidine and haloperidol injection|
16054511|NCT02493192|Other|birth ball|
16054512|NCT02493179|Drug|Serodase 5 mg|Serodase 5mg two tablets three times per day
16054513|NCT02493179|Drug|Placebo|Placebo two tablets three times per day
16054514|NCT02493166|Other|dual task cost (cognitive-motor interference)|comparing single versus dual task performance (on both motor and cognitive task)
16054515|NCT02493153|Procedure|Laparoscopic Cholecystectomy|Laparoscopic cholecystectomy
16054516|NCT02493140|Dietary Supplement|Cashew apple extract (Cashewin)|6 capsules per day (2 capsules 3 times per day, to be taken before breakfast, lunch and diner, each capsule containing 200 mg of Cashewin) during 12 weeks
16054517|NCT02493140|Dietary Supplement|Placebo|6 capsules per day (2 capsules 3 times per day, to be taken before breakfast, lunch and diner) during 12 weeks
16054518|NCT02493127|Other|Standard PCS|Subject completes the standard version of the PCS Questionnaire
16054519|NCT02493127|Other|Grip Strength|Research Assistant takes Grip Strength Measurements
16054520|NCT02493127|Other|Positively Adjusted PCS|Subject completes the positively-adjusted version of the PCS Questionnaire
16054521|NCT02493088|Other|Antisocial personality recording of behavior and contextual elements|aberrant driving behaviors and upstream contextual elements of individuals diagnosed with antisocial personality disorder will be recorded during the study
16054522|NCT02493075|Behavioral|The operator blinded to the contact force data or not.|"CF guided group: ablation will be performed with the guidance of real-time CF, ablation time, FTI, etc. CF will be controlled in the range of appropriate CF, which has been defined in phase I. Circumferential PV ablation will be performed orderly, isolated segment, acute reconnected segment , and unisolated segment will be also identified as described in phase I.
~Usual ablation group:
~Operator will be blinded to CF data, the procedure performance is the same as described in phase I."
16054523|NCT02493062|Device|Sonohysterogram|The sonohysterogram can measure the size and depth of the uterine scar allowing better predictive values for future pregnancies.
16054524|NCT02493049|Drug|Domperidone|Addition of Domperidone to current Disease Modifying Therapy.
16054525|NCT02493036|Drug|SYN-010|
16054526|NCT02493023|Device|navigated bronchoscopy|
16054527|NCT02493010|Device|Arousal-based biofeedback system|
16054566|NCT02492737|Drug|AG881|AG-881 administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Patients may continue treatment with AG-881 until disease progression or development of other unacceptable toxicity
16055037|NCT02489240|Drug|placebo|2000 IU placebo tablets were taken daily for 6 days
16055038|NCT02489227|Drug|CHS-1420|
16054528|NCT02492997|Device|Venus Versa|The Venus Versa system is a console that supports an applicators that simultaneously emits radio frequency (RF) and a Pulsed Magnetic Field (PEMF). This combination of energy can raise the temperature of treatment area quickly and homogeneously. The Pulsed Magnetic Field is induced by short pulses of electrical current through coil in the applicator. The magnetic field penetrates into the skin and results in Foucault (Eddy) electrical currents around the cell membranes of the treated tissues. Foucault currents change the electrical potential of charged receptors on the bi-lipid cell membrane layer of dermal cells, which results in the stimulation of molecular and cellular activities and reactions.
16054529|NCT02492997|Other|Glycerine gel|Gel used to protect the skin from the RF energy and to assist with energy distribution
16054530|NCT02492984|Drug|Intravenous infusions of Xyntha|Enrolled subjects will be treated with intravenous infusions of Xyntha for: • On-Demand treatment, • Surgical Prophylaxis at a dose and frequency prescribed by the subject's treating physician in accordance with the Xyntha label and will be adjusted solely according to medical and therapeutic necessity.
16054531|NCT02492958|Biological|Staphylococcus aureus 4-antigen vaccine|a single 0.5 mL dose of investigational product into the deltoid muscle in the upper arm
16054532|NCT02492958|Biological|Placebo|a single 0.5 mL dose of investigational product into the deltoid muscle in the upper arm
16054533|NCT02492945|Drug|3ml-Rejuvinex|They take the three times of the ultrasonography-guided 3ml-Rejuvinex as a PDRN group for four weeks(0,2,4 weeks) under double-blind.
16054534|NCT02492945|Drug|3ml-15%-dextrose solution|They take the three times of the ultrasonography-guided 3ml-15%-dextrose solution injections as a Dextrose group for four weeks(0,2,4 weeks) under double-blind.
16054535|NCT02492932|Device|Ultrasonography|Ultrasonography evaluation of the internal jugular vein.
16054536|NCT02492919|Device|Medixair®|Medixair system uses C-ultraviolet rays, which are the strongest ultraviolet kind of rays to kill microorganisms. The intervention consist consists of adding the Medixair® device, to be various beds of Cardiac Reanimation Units, or not.
16054537|NCT02492906|Other|Osteoarthrosis|Primary severe knee osteoarthrosis and chronic knee pain.
16054538|NCT02492906|Other|Healthy|Healthy and non-symptomatic volunteers.
16054539|NCT02492893|Other|Hatha yoga|
16054540|NCT02492880|Device|Precision Spectra™ SCS system programming features|Precision Spectra™ SCS system programming features using the CoverEdge surgical lead.
16054541|NCT02492867|Radiation|Response-driven Adaptive Radiation Therapy|
16054542|NCT02492867|Drug|Carboplatin|AUC 2 concurrent with RT; AUC 6 during consolidation. Given IV
16054543|NCT02492867|Drug|Paclitaxel|40 mg/m^2 IV concurrent with RT; 200 mg/m^2 during consolidation. Given IV
16054544|NCT02492867|Device|FDG-PET|
16054545|NCT02492867|Device|V/Q SPECT|
16054546|NCT02492867|Drug|Durvalumab|10 mg/kg during consolidation. Given IV
16054547|NCT02492854|Device|PICO Single-Use Negative Pressure Dressings|Negative pressure wound therapy (NPWT), over the past several years, has provided a way to post-operatively manage complex wounds. This is a therapy with potential to decrease rates of SSIs post-LE bypass. Unlike standard gauze dressings, negative pressure wound therapy provides a sealed, moist environment and shuttles fluid away from the wound. A suctioning unit applies even, negative pressure (typically -80 to -120 mmHg) and exudate is suctioned and collected in a control unit. The investigators would like to investigate the efficacy of PICO (Smith&Nephew), a single-use one-step wound dressing which is effective for 7 days. It is lightweight and uses a small hand-held vacuum pump, both of which allow for ease of use. PICO has been FDA-approved.
16054548|NCT02492854|Other|Sterile Gauze Dressings|Current standard-of-care dressings used to cover surgical wounds post-operatively.
16054549|NCT02492841|Drug|Mineral trioxide aggregate|Mineral trioxide aggregate
16054550|NCT02492841|Drug|Calcium hydroxide|Classic calcium hydroxide root canal repair material. Inorganic compound (CA(OH)2. It is the gold standard direct pulp cupping material.
16054551|NCT02492841|Drug|Biodentine|Biodentine (trademark). Septodont. Biodentine root canal repair material. A predose capsule plus five drops of calcium chloride solution.
16054552|NCT02492802|Drug|posaconazole|collection plasma samples for measuring posaconazole drug concentration
16054553|NCT02492789|Biological|INCSHR01210 injection|"Part1: INCSHR01210 injection at a dose of 1, 3 or 10 mg/kg is administered every 2 weeks (3+3,q2w, except in the first cycle, in which subjects will be only dosed once on Day 1 for PK samplings and dose limiting toxicity observation). Response is assessed by every 2 cycles (4 weeks each cycle) by using irRECIST.
~Part2: Additional patients (200mg dose cohorts will be enrolled in Part 2, depending on the data outcomes in Part 1, to further explore preliminarily clinical benefits of INCSHR01210 as well as the other objectives of the study."
16054554|NCT02492776|Drug|Omeprazole|20 mg oral capsules administered once daily for 8 days
16054555|NCT02492776|Drug|Gefapixant|Gefapixant oral tablet (25 mg administered as a divided 50 mg tablet) administered twice daily for 5 days
16054556|NCT02492776|Drug|Gefapixant|Gefapixant oral tablet (50 mg tablet) administered twice daily for 8 days
16054557|NCT02492763|Drug|MK-8521|Dose strengths: 180 μg QD administered subcutaneously. A 2-step dose escalation regimen [60 μg, 120 μg] over the first 2 weeks is used to achieve the final dose up to 180 μg.); 300 μg QD administered subcutaneously (A 3-step dose escalation regimen [60 μg, 120 μg, 180 μg] over the first 3 weeks is used to achieve the final dose up to 300 μg.
16054558|NCT02492763|Drug|Placebo|Double dummy matching placebo for the MK-8521 and placebo arms: matching placebo for MK-8521 300 μg QD administered subcutaneously; matching placebo for MK-8521 180 μg QD administered subcutaneously. A dose escalation regimen consistent with that of the MK-8521 300 μg and 180 μg arms of the study; mock escalation will be performed over the first 2 to 3 weeks.
16054559|NCT02492763|Drug|Liraglutide|Dose strength: 1.8 mg QD administered subcutaneously. A 2-step dose escalation regimen (0.6 mg, 1.2 mg) over the first 2 weeks is used to achieve the final dose up to 1.8 mg.
16054560|NCT02492763|Drug|Metformin|Metformin immediate release (IR) or metformin extended release (XR) administered ≥1000 mg QD as background therapy
16054561|NCT02492750|Biological|Anakinra|Given SC
16054562|NCT02492750|Drug|Dexamethasone|Given PO
16054563|NCT02492750|Other|Laboratory Biomarker Analysis|Correlative studies
16054564|NCT02492750|Drug|Lenalidomide|Given PO
16054565|NCT02492750|Other|Placebo|Given SC
16055039|NCT02489227|Drug|Adalimumab|
16054573|NCT02492698|Dietary Supplement|Probiotic group|The 2 g of probiotic powder contained 0.1 g of Lactobacillus curvatus HY7601, 0.1 g of Lactobacillus plantarum KY1032, 1.24 g of crystalline cellulose, 0.5 g of lactose, and 0.06 g of blueberry-flavoring agent.
16054574|NCT02492698|Dietary Supplement|Placebo group|The 2 g of placebo powder contained 1.34 g of crystalline cellulose, 0.6 g of lactose, and 0.06 g of blueberry-flavoring agent.
16054575|NCT02492685|Device|Quantitative analysis by using the new developed software program VueBox|After acquiring the EUS image by a regular procedure of EUS and contrast-enhanced with one of the fluoro-gas-containing contrast agents (SonoVue, Bracco, Germany), whole video is recorded on the embedded HDD (hard disk drive) of the US system for later analysis. The videos will be analyzed by using the VueBox software (Bracco Suisse SA, Geneva, Switzerland). After surgical treatment, we will compare the results of quantitative analysis with surgical pathology.
16054576|NCT02492659|Procedure|femtosecond laser-assisted cataract surgery|the femtosecond laser platform was used to generate capsulotomy with a diameter as described above in the control group, and lens fragmentation into 6 segments.
16054577|NCT02492659|Procedure|conventional phacoemulsification|continuous curvilinear capsulorhexis was performed with capsulorrhexis forceps. Following hydrodissection, phacoemulsification of the nucleus, aspiration of the residual cortex and capsular polishing were performed using a phacoemulsification machine
16054578|NCT02492646|Procedure|Saline group|After anesthetic induction, patients will be intubated with endotracheal tube which was immersed in normal saline before intubation.
16054579|NCT02492646|Procedure|Dry group|After anesthetic induction, patients will be intubated with endotracheal tube which was not immersed in normal saline.
16054580|NCT02492633|Behavioral|Control|The Standard Intervention will be offered to residents at all of Beacon Communities properties, regardless of the presence of this study. The standard intervention will be implemented as part of the smoke-free initiative roll out and will consist of: monthly articles in newsletters, re-usable shopping bag giveaways touting cessation messages, information provided via the property websites, and training of Residential Service Coordinators (RSCs) using the 8-session smoking cessation group training provided by the American Lung Association. The RSCs will offer group cessation counseling sessions for residents who would like support to quit smoking.
16054581|NCT02492633|Behavioral|Intervention|"At a subset of 6 Beacon Communities properties, residents will receive an 'enhanced intervention' in addition to the 'standard intervention' that Beacon Communities is already providing. The enhanced intervention will consist of the following:
~A web-based smoking cessation intervention via Facebook
~Enhanced gain-framed messaging communicated via several channels. Gain framed messages will incorporate themes of smoking cessation and policies which aim to distinguish from the vast 'library' of traditional messages which focus on loss-framing.
~A behavioral nudge designed to enhance public support for the smoke free policy, through personal adoption and adherence to the policy. This will be done by promoting a publicly viewable pledge program."
16054582|NCT02492620|Drug|Ferric Citrate|Auryxia (ferric citrate) is a non calcium based phosphate binder indicated for the control of serum phosphorus levels in patients with chronic kidney disease on dialysis
16054583|NCT02492607|Other|Standard treatment|"wide local excision only or wide local excision and radiotherapy or mastectomy.
~+/- hormonal therapy"
16054584|NCT02492607|Device|digital mammography|annual mammography
16054585|NCT02492607|Radiation|radiotherapy|according local policy
16054586|NCT02492594|Other|Peripheral blood sampling|"Peripheral blood samples will be taken at 3-5 defined timepoints during febrile neutropenia:
~at the start of neutropenic fever
~after 24 hours
~after 48 hours
~before the start of antimycotic therapy, if pertinent
~at the end of antimycotic therapy, if pertinent"
16054587|NCT02492581|Drug|Nalmefene|No intervention on the use of Selincro. The physician will prescribe Selincro following its usual practice.
16054588|NCT02492568|Drug|pembrolizumab|
16054589|NCT02492568|Radiation|Stereotactic Body Radiation Therapy|
16054590|NCT02492555|Other|SI|A routine scheduled (SI) screening of FC and DA every 3rd month
16054591|NCT02492555|Other|OD|A screening of FC and DA on demand (OD)
16054592|NCT02492542|Device|PHENIX USB 8.|Electrical stimulation program: frequency: 1/4/Hertz (HZ), pulse width: 270/230/270 μs, time: 30min. Electrode piece: 50*50mm sticky electrode plate. Position: an electrode piece is placed in the S3, and an electrode piece is placed in the bladder region.Current intensity adjusted according to the patient's tolerance, the maximum current intensity of the pain was not appropriate, generally not more than 100milliampere(mA).Devices PHENIX USB 8.
16054593|NCT02492529|Other|Neuropsychological tests|"Scales and tests to evaluate:
~Global cognitive performance
~Handedness
~Memory functions performance
~Gestural praxis functions performance
~Lexical and semantic functions performance
~Executive functions performance
~Memory disorders
~Way of life
~Mood"
16054594|NCT02492529|Device|A cranial MRI|
16054595|NCT02492529|Other|Experimental procedure|
16054596|NCT02492516|Biological|mesenchymal stem cells|mesenchymal stem cells injection via peripheral vein.
16054597|NCT02492503|Drug|Paclitaxel and carboplatin|Paclitaxel 60 mg/ m2 administered in 250 ml normal saline over 1 hour, and carboplatin AUC 2 administered in 250 ml 5%D over 1 hour. Therapy repeated every weekly
16054598|NCT02492503|Drug|Paclitaxel and carboplatin|Paclitaxel 175 mg/ m2 administered in 250 ml normal saline over 3 hours and carboplatin AUC 4-5 administered in 250 ml 5%D over 2 hours. Therapy repeated every three weekly
16054599|NCT02492490|Other|SVFderived MSC transplantations|"infusion of autologous SVF derived MSC to the recipients of DCD kidney transplant.
~Subjects with uremia in the intervention group will undergo puncture to collect SVF, then SVF will be cultured to abstain MSC, and the abstained MSC will be infused to the recipients during kidney transplant operation and on 7, 14, and 21 POD. And the induction therapy of control group will be Basiliximab."
16054600|NCT02492490|Drug|Basiliximab|induction with Basiliximab before kidney transplantation and on POD 4
16054601|NCT02492477|Procedure|evaluation of PORT-A-CATH®|in patients in curative setting, clinical assessment, PORT-A-CATH® testing of possibility of saline-administration and blood withdrawal with vacutainer, laboratory assessment
16054602|NCT02492477|Drug|blocking with Medunasal®-Heparinblock|blocking of the functioning PORT-A-CATH® with heparinized 0,9% NaCl solution
16054603|NCT02492477|Drug|restoration of PORT-A-CATH® with Alteplase|by malfunction of the PORT-A-CATH® attempting of restoration with Actilyse® according to guidelines
16054604|NCT02492464|Dietary Supplement|Red yeast rice|1 capsule to be taken before to sleep, each day, for 6 months
16054605|NCT02492464|Dietary Supplement|Placebo|
16054606|NCT02492451|Other|Endometrial Injury|Endometrial injury in luteal phase of preceding cycle by pipelle canula
16054607|NCT02492451|Drug|progesterone (Crinone® %8 vaginal progesterone gel)|Luteal phase support with progesterone (Crinone® %8 vaginal progesterone gel) in IUI cycle Vaginal progesterone gel is administered from second day after insemination until pregnancy testing and is continued in the presence of pregnancy until the 12 weeks of pregnancy.
16054608|NCT02492438|Biological|PPV23 vaccination or PCV13 vaccination|
16054609|NCT02492412|Drug|HE 10|
16054610|NCT02492412|Drug|Restasis|
16054611|NCT02492399|Procedure|extended myectomy|The scheme of extended septal myectomy: Two parallel incisions were made into the septal bulge and connected to remove the muscle mass. Myectomy was extended to the base of the papillary muscles, when midseptal thickening was present. The papillary muscles were grasped and pushed medially to visualize the abnormal connections between the papillary muscles and the anterior wall of the ventricle. A blade was used to divide the thickened abnormal attachments. A pituitary rongeur may be used to resect a portion of the junction of the papillary and lateral wall. This reduces the diameter of the papillary muscle and allows for posterior displacement of the anterior mitral leaflet. Division of abnormal attachments and thinning of the papillary muscles is critical for the treatment of SAM.
16054612|NCT02492399|Procedure|myectomy by Morrow|A first myotomy is made into the septum just below the base of the right coronary leaflet at a point 2-3 mm to the right of the commissure between the left and right coronary leaflets. A second myotomy is made in the same manner, parallel to the first one and about 1 cm to the right of it. The two vertical myotomies are made and cornnected transversely in the interventricular septum. The muscle bar is then grasped with the angled rongeur and the instrument is pushed firmly toward the apex, peeling the mtusele from its anterior septal attachments. After completion of the resectioni, a rectangular channel about 1 X 1.5 cm is palpable from the valve ring toward the apex for a dis- tance of about 4 cm.
16054613|NCT02492386|Device|Bioabsorbable everolimus-eluting stent deployment|Bioabsorbable everolimus-eluting stent deployment
16054614|NCT02492373|Drug|topical 0.05% Clobetasol propionate ointment|Apply only on the treated area twice a day as mentions
16054615|NCT02492373|Device|Q switched Nd:YAG laser 532 nm|Treatment of facial lentigines. The energy using depends on the endpoint of immediate whitening of the lesions.
16054616|NCT02492360|Procedure|Blood sample collection|Six tubes of blood will be collected during one blood draw.
16054617|NCT02492360|Behavioral|Report of peripheral neuropathy after cisplatin therapy|Twenty questions about the peripheral neuropathy the patient is currently experiencing, and twenty questions about the worst peripheral neuropathy the patient ever experienced after cisplatin treatment.
16054618|NCT02492347|Procedure|Electrocardiogram|The ECG is a non-invasive screening tool. It will be performed when the neonate is settled and comfortable. The electrodes used are made with soft jelly adhesive which is stored at room temperature. The procedure will be conducted in a timely manner, taking no longer than 15 minutes. The electrodes are easily removed, and the neonate redressed.
16054619|NCT02492321|Drug|EBI-005|
16054620|NCT02492321|Drug|Placebo Comparator|
16054621|NCT02492308|Procedure|SVF-MSC induction|"Procedure: infusion of autologous SVF derived MSC to the recipients of living-relative kidney transplant.
~Subjects with uremia in the intervention group will undergo puncture to collect SVF, then SVF will be cultured to abstain MSC, and the abstained MSC will be infused to the recipients during kidney transplant operation and on 7, 14, and 21 POD"
16054622|NCT02492308|Drug|Basiliximab induction|The control group will be inducted with Basiliximab before living-relative kidney transplantation and on POD 4
16054623|NCT02492295|Drug|Propofol|"Propofol will be administered as a 0.5mg/kg (at a concentration of 10mg/mL, rounded to the nearest 0.5mL) initial bolus, followed by repeat 0.25mg/kg boluses (same rounding) every three to five minutes as needed to maintain RASS target -2 (light sedation - awakens to voice <10 seconds) to RASS target of -3 (moderate sedation - movement or eye opening without eye contact) for 15 minutes. No more than 1.5mg/kg of propofol will be administered over this time period. After the sedation session is complete, patients will be allowed to wake up and will be monitored in the ED for at least another hour prior to discharge."
16054624|NCT02492282|Device|Closed-Loop propofol and remifentanil system by Bispectral Index|
16054625|NCT02492282|Device|Open-Loop propofol and remifentanil by Target Controlled Infusion|
16054626|NCT02492282|Drug|propofol|
16054627|NCT02492269|Drug|Dexmedetomidine|
16054628|NCT02492269|Drug|Placebo|
16054629|NCT02492256|Device|Pulmonary vein isolation|CARTO- reconstruction LA, preferably during same rhythm as SUMO map (generally sinus rhythm) for use during registration of SUMO map in CARTO. Conventional PVI by circumferential antral ablation according to standard procedures. Exit and Entrance block conformation. Attempt to induce sustained atrial tachycardia. Optional mapping and ablation of post-ablation atrial tachycardia.
16054630|NCT02492256|Device|GP ablation guided by SUMO technology|"CARTO- reconstruction LA, preferably during same rhythm as SUMO map (generally sinus rhythm) for use during registration of SUMO map in CARTO. High frequency stimulation (HFS; 20-Hz frequency, 5-ms pulse duration, and 15-mA output) to access positive vagal response (the heart rate decreasing by 50% at baseline). RF Ablation of SUMO hotspots (in sinus rhythm if AF converts)
~• Target a region of 1.0-1.5 cm diameter around the SUMO 'hotspot'. Control HFS. Attempt to induce sustained atrial tachycardia. Optional mapping and ablation of post-ablation atrial tachycardia."
16054631|NCT02492256|Device|ILR implantation|Implantation the ECG loop recorder according to standard procedure
16054632|NCT02492243|Device|PCI|
16054633|NCT02492243|Device|ILR implantation|
16054769|NCT02491229|Other|Hepafast|Two weeks of Hepafast three times a day and additionally 200 kcal followed by 10 weeks of Hepafast two times a day and a meal according to LOGI diet
16054634|NCT02492230|Device|Left Atrial Appendage Closure Device (Watchman)|This device is a self-expanding nickel titanium (nitinol) frame structure with fixation barbs and a permeable polyester fabric cover. The device ranges in diameter from 21 mm to 33 mm to accommodate varying LAA anatomy and size. It will be implanted via a trans-septal approach by use of a catheter based delivery system to seal the ostium of the LAA. The implantation will be guided by fluoroscopy and TEE to verify proper positioning and stability. The dose of warfarin will be adjusted to maintain INR 2.0 - 3.0 for 45 days. If TEE data shows no additional flow in LAA, warfarin will be discontinued: Aspirin dose: 75 mg for all period of study; Clopidogrel dose: 75 mg for 6 months after procedure.
16054635|NCT02492230|Drug|Warfarin|"Warfarin dose adjusted to maintain INR 2.0-3.0 for all period of study; Aspirin dose-75mg for 45 days after randomization; Clopidogrel dose-75mg for 6 months after procedure.
~All drugs will be started before PCI procedure. Low molecular weight heparins will be used before procedure and will be stopped when INR reach 1.8-2.0."
16054636|NCT02492217|Drug|Adalimumab|
16054637|NCT02492191|Device|Smartphone app Recovery Assessment by Phone Points (RAPP)|An e-assessed follow-up of day surgery patients postoperative recovery measured via smartphone app
16054638|NCT02492178|Drug|Intrarectal artesunate|
16054639|NCT02492178|Drug|Intravenous artesunate|
16054640|NCT02492178|Drug|Intravenous quinine|
16054641|NCT02492165|Biological|Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)|0.5 mL, Subcutaneous
16054642|NCT02492165|Biological|Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)|0.5 mL, Subcutaneous
16054643|NCT02492165|Biological|Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)|0.5 mL, Subcutaneous
16054644|NCT02492165|Biological|Live attenuated Japanese encephalitis chimeric virus vaccine (IMOJEV®)|0.5 mL, Subcutaneous
16054645|NCT02492152|Device|Study group|Dianatal
16054646|NCT02492139|Device|Pumping CE-marked Symphony Pumpset|Pumping with the CE-marked Symphony Pumpset
16054647|NCT02492139|Device|Pumping BrownieForSymphony Pumpset|Pumping with the the BrownieForSymphony Pumpset
16054648|NCT02492126|Other|Citric Acid|Subjects will undergo cough reflex sensitivity testing to citric acid.
16054649|NCT02492113|Procedure|Positive end-expiratory pressure (PEEP)|"Titrated-PEEP. After recruitment maneuver and decremental PEEP trial, the Titrated-PEEP is identified. Patients will have two spontaneous breathing trials (SBTs). In this arm, patients will have SBT at Titrated-PEEP, with the PSV=0 and FiO2 unchanged."
16054650|NCT02492113|Procedure|ZEEP|"After recruitment maneuver and decremental PEEP trial, the Titrated-PEEP is identified. Patients will have two spontaneous breathing trials (SBTs). In this arm, patients will have SBT at PEEP = 0-5 cmH2O, with the PSV=0 and FiO2 unchanged."
16054651|NCT02492100|Behavioral|Multi-modality sexual dysfunction intervention|
16054652|NCT02492087|Drug|Topical tranexamic acid|Topical tranexamic acid 2g diluted with normal saline 0.9% to a volume of 120mls solution (Concentration 16.7mg/ml)
16054653|NCT02492087|Drug|Normal saline 0.9%|Sterile Normal saline 0.9% 120mls solution
16054654|NCT02492074|Drug|Delta-9-tetrahydrocannabinol|oral administration of delta-9-tetrahydrocannabinol
16054655|NCT02492074|Drug|Cannabidiol|oral administration of cannabidiol
16054656|NCT02492074|Drug|Placebo|oral administration of placebo
16054657|NCT02492061|Behavioral|Demand creation for couples' HCT|The demand creation for couples' HCT intervention aims at improving uptake of couples' HCT among married couples in Rakai, southwestern Uganda
16054658|NCT02492048|Device|Cellutome Epidermal Harvesting System|Cellutome Epidermal Harvesting System
16054659|NCT02492048|Procedure|Split Thickness Skin Graft|Split Thickness Skin Graft
16054660|NCT02492035|Behavioral|Lifestyle intervention|
16054661|NCT02492022|Dietary Supplement|Probiotic L008-1|Dosing regimen of 2 capsules daily, once per day, for 14 weeks
16054662|NCT02492022|Dietary Supplement|Probiotic L008-2|Dosing regimen of 2 capsules daily, once per day, for 14 weeks
16054663|NCT02492022|Other|Placebo|Dosing regimen of 2 capsules daily, once per day, for 14 weeks
16054666|NCT02491996|Behavioral|desire satisfaction-targeted intervention for disordered gamblers|This intervention consists of an initial psychiatric assessment, followed by psychoeducational approach based on desire satisfaction-targeted intervention by psychiatrists, and three group sessions based on CBT by psychologists. Patients with psychiatric comorbidities are treated with the appropriate pharmacological regimens.
16054667|NCT02491983|Drug|Palbociclib|
16054668|NCT02491983|Drug|Fulvestrant|
16054669|NCT02491983|Drug|Letrozole|
16054670|NCT02491970|Drug|Fluticasone/Formoterol|
16054671|NCT02491970|Drug|Fluticasone/Salmeterol|
16054672|NCT02491957|Other|LOFT Therapy|"LOFT Therapy™ will be performed 2 times a week for 4 weeks a total of 8 sessions. The patient will be wrapped with fabric cuffs, on up to four limbs. The cuffs are applied to the widest part of the biceps and upper thighs at pressures between 80-100 mmHg with minimal venous encroachment. The patients will ride a recumbent bike for 18 total minutes of sub-maximal exertion (up to 70% repetition maximum ), with the option of up to 2 periods of 15-second higher intensity exertions as tolerated, followed by individualized respiratory recovery periods determined by the relative decrease in breathing effort.
~The 18-minute session will be preceded by a two-minute compression check, where the wraps will be adjusted based on any signs or symptoms of nerve or vessel impingement."
16055040|NCT02489214|Drug|donafenib tosilate tablets|200mg bid
16054674|NCT02491944|Drug|[14C]AZD9291|Each healthy male subject will also receive a single, radiolabeled, 100 μg dose of [14C] AZD9291 administered as an IV microdose infusion starting at 5 hours and 45 minutes after receiving the oral dose.
16054675|NCT02491931|Dietary Supplement|Supplement/placebo intake|Patients will receive either GLN or placebo prior to cardiovascular surgery under extracorporeal circulation, during 3 days and one final dose 4 hours prior to anesthesia.
16054676|NCT02491918|Procedure|cataract surgery|cataract surgery in children
16054677|NCT02491918|Procedure|Intraocular lens implantation|intraocular lens implantation in the capsular bag or optic capture
16054678|NCT02491905|Drug|HL tablet|
16054679|NCT02491905|Drug|Placebo|
16054680|NCT02491892|Drug|Pertuzumab|Participants will receive one of two IV treatment regimens with pertuzumab: either 420 mg every 3 weeks, with an initial 840-mg loading dose, or 1050 mg every 3 weeks with no loading dose administered.
16054681|NCT02491879|Drug|Ketoprofen|2.5% Ketoprofen gel with a 2 g local use
16054682|NCT02491879|Other|Placebo|Placebo gel with a 2 g local use
16054683|NCT02491866|Other|to develop and validate a Computerized Adaptative Testing|"Elaboration of a pool of items, based on literature review and interview with patients.
~Selection of the most relevant items based on a qualitative approach using cognitive interview with patients.
~Calibration of the item bank : the psychometric properties of the item bank will be based on classical test and item response theories and approaches, including the evaluation of unidimensionality, item response theory model fitting, and analyses of differential item functioning.
~Metrological validation of the CAT.
~Analysis of the implementation of the CAT in clinical practice using interview with professionals and patients."
16054684|NCT02491853|Device|Implantable Cardioverter Defibrillator|Implantable Cardioverter Defibrillator
16054685|NCT02491840|Procedure|Biopsy|Biopsy of Gastric and cardia adenocarcinomas
16054686|NCT02491827|Other|Cellvizio mini laser probe|Cellvizio mini laser probe is administered via the endoscopic device used during the neurosurgical procedures to provide the optical biopsy
16054687|NCT02491814|Other|1% M.F. Milk|
16054688|NCT02491814|Other|Yogurt Beverage|
16054689|NCT02491814|Other|Soy Beverage|
16054690|NCT02491814|Other|Almond Beverage|
16054691|NCT02491814|Other|Water|
16054692|NCT02491814|Other|Breakfast cereal|
16054693|NCT02491801|Other|Dietary intervention|All arms are given to all participants, in a randomized order
16054694|NCT02491788|Drug|Suvorexant|
16054695|NCT02491788|Drug|Placebo|
16054696|NCT02491762|Procedure|respiratory function tests|FVC, FEV1, MVV, FRC, RV, TLC, MIP, MEP
16054697|NCT02491749|Procedure|Ultra Fast-Track Anesthesia|early extubation at the end or within one hour post operatively
16054698|NCT02491736|Drug|Ketoprofen|2.5% ketoprofen gel
16054699|NCT02491736|Other|Placebo|Placebo gel
16054700|NCT02491723|Drug|Azithromycin|Patients with bronchiectasis treated with Azithromycin for three to five days.
16054701|NCT02491710|Device|Training on low-cost box trainer|
16054702|NCT02491710|Device|Training on standard box trainer|
16054703|NCT02491697|Biological|DC-CIK Immunotherapy|DC-CIK cells are used to treat advanced breast cancer with capecitabine.
16054704|NCT02491697|Drug|Capecitabine Monotherapy|All patients receive capecitabine monotherapy (2500 mg/m2 twice daily) for 2 weeks followed by a 1-week rest period.And the treatment is repeated every 3 weeks.
16054705|NCT02491684|Drug|Interferon beta-1a Nebuliser solution 48 μg/mL|Interferon beta-1a, 0,5 ml (24 μg, metered dose) once daily inhalation for 14 days
16054706|NCT02491684|Drug|Placebo|Placebo solution for once daily inhalation for 14 days
16054707|NCT02491671|Device|Hemopatch|
16054708|NCT02491671|Procedure|standard preventive measures|
16054709|NCT02491658|Biological|UC-MSCs|Psoriasis Vulgaris patients will receive 6 times UC-MSCs infusions (each time 1×10^6/kg). The first time to fourth time will be given once a week for successive 4 weeks, then the last two times will be given once every two weeks.
16054710|NCT02491645|Other|Sensory interventions|"Tactile stimulation: Brushing technique , handling materials of various textures, bear hug and rug , play dough and find in rice techniques to be done.
~Proprioception technique : Joint compression , popping bubbles, lifting weights of different measures and scooter board push activities to be done.
~Movement/vestibular techniques :Bear hug and rug , swinging or rocking motion, jumping or spinning to be done.
~Visual stimulation : picture recognition, dot colouring , lighting balls and toys , familiarisation of emotions to be done.
~Auditory stimulation : Sound familiarisation and music time will be done."
16054711|NCT02491632|Drug|Dexamethasone|Given PO
16054712|NCT02491632|Behavioral|Exercise Intervention|Complete a graded resistance exercise program and a walking regimen
16054713|NCT02491632|Other|Laboratory Biomarker Analysis|Correlative studies
16054714|NCT02491632|Other|Quality-of-Life Assessment|Ancillary studies
16054715|NCT02491632|Other|Questionnaire Administration|Ancillary studies
16054716|NCT02491619|Procedure|orthodontic decompensation|Evaluation of the correlation between bone thickness and tooth inclination previously and after orthodontic treatment of decompensation due to orthognathic surgery
16054717|NCT02491606|Drug|Tafenoquine|Tafenoquine 200mg and 400 mg
16054718|NCT02491606|Other|Placebo|Placebo
16054719|NCT02491593|Device|fecal occult blood test|
16054720|NCT02491554|Device|Conventional AC-PC based implantation of ACTIVA INS DBS system|Conventional AC-PC based implantation of ACTIVA INS DBS system (manufactured by Medtronic) in the thalamic/subthalamic region (Vim-cZI).
16054721|NCT02491554|Device|MR-tractography guided implantation of ACTIVA INS DBS system|MR-tractography guided implantation of ACTIVA INS DBS system (manufactured by Medtronic) in the DRT.
16054722|NCT02491541|Biological|Changchun Werersai|"A rabies vaccine (Vero Cell) for human use produced by Changchun Werersai Biotech Pharmaceutical Co., Ltd.
~1.0 ml experimental vaccine on day 0,3,7,14,28"
16054723|NCT02491541|Biological|Jilin Maifeng|"A rabies vaccine (Vero Cell) for human use produced by Jilin Maifeng Biotech Pharmaceutical Co., Ltd.
~1.0 ml comparator vaccine on day 0,3,7,14,28"
16054724|NCT02491528|Biological|insulin Aspart injection|Subcutaneous injection of insulin Aspart prior to three meals every day, while subcutaneous injection of Lantus at bedtime.
16055041|NCT02489201|Drug|donafenib tosilate tablets|200mg,bid
16054725|NCT02491528|Biological|insulin Aspart injection (NovoRapid)|Subcutaneous injection of insulin Aspart injection (NovoRapid) prior to three meals every day, while subcutaneous injection of Lantus at bedtime.
16054726|NCT02491515|Drug|Denosumab|every 6 month injection
16054727|NCT02491502|Device|Echopulse|HIFU Under ultrasound guidance
16054728|NCT02491489|Other|Glenohumeral mobilization|Participants will then be placed supine on a standard plinth. The investigators will then proceed to provide a mobilizing force to the participant's glenohumeral joints. Each of two investigators will, in sequence perform a 15 second longitudinal distraction, followed by a 15 second posteriorly directed glenohumeral glide with the shoulder placed in the open pack resting position (~50 degrees abduction, slight horizontal adduction, external rotation).
16054729|NCT02491476|Device|intracerebral micro-macroelectrodes|All patients will be implanted with usually 4 micro-macroelectrodes (replacing the regular clinical macroelectrodes). The primary and secondary outcomes will then be assessed.
16054730|NCT02491463|Biological|GSK3389245A_LD GROUP|2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm
16054731|NCT02491463|Biological|GSK3389245A_HD GROUP|2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm
16054732|NCT02491463|Biological|Bexsero|2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm
16054733|NCT02491463|Drug|Placebo|2 doses administered intramuscularly at Day 0 and Day 30 in the deltoid region of the non-dominant arm
16054734|NCT02491450|Drug|Heterosofir|1 tablet contains 400 mg sofosbuvir
16054735|NCT02491450|Drug|Sovaldi|1 tablet contains 400 mg sofosbuvir
16054736|NCT02491437|Drug|Dydrogesterone 30 mg|Oral Dydrogesterone 10 mg tablets tid
16054737|NCT02491437|Drug|intravaginal progesterone gel 90 mg|
16054738|NCT02491424|Device|Direct skeletal fixation of ITAP to lower limb amputees.|Intraosseous Transcutaneous Amputation Prosthesis (ITAPTM) fitting. The core ITAP™ design comprises of three discrete sections, the proximal section, which is the intramedullary stem secured into the medullary canal, the soft tissue integration flange and the transcutaneous component that passes through the skin.
16054739|NCT02491411|Drug|Dexamethasone|Given PO
16054740|NCT02491411|Drug|Enzalutamide|Given PO
16054741|NCT02491411|Other|Laboratory Biomarker Analysis|Correlative studies
16054742|NCT02491411|Other|Quality-of-Life Assessment|Ancillary studies
16054743|NCT02491398|Drug|Bendamustine + Rituximab|
16054744|NCT02491385|Procedure|thoracic epidural analgesia|In a sitting position, an 18-gauge Tuohy needle is introduced at T6-7 or T7-8 intervertebral space using a paramedian approach. An epidural catheter is advanced 5 cm beyond the tip of the needle and secured with a sterile dressing. For TEA regimen, hydromorphone (8 mcg/ml) was added to 0.15% ropivacaine. TEA setting was bolus/lock out time/basal, 3 ml/15 min/5 ml.
16054745|NCT02491385|Drug|iv-PCA|iv-PCA setting was fentanyl 20 mcg/ml, bolus/lock out time/basal, 0.5 ml/15 min/0.5 ml.
16054746|NCT02491372|Behavioral|Acceptance and Commitment Therapy|ACT is a psychological intervention that aims to promote adaptive coping and encourages participants to move their focus away from trying to control emotions to accepting and adapting to them. It is relevant to all patients, not just those who are currently distressed.
16054747|NCT02491359|Drug|Carfilzomib|Given IV
16054748|NCT02491359|Other|Laboratory Biomarker Analysis|Correlative studies
16054749|NCT02491359|Other|Quality-of-Life Assessment|Ancillary studies
16054750|NCT02491359|Other|Questionnaire Administration|Ancillary studies
16054751|NCT02491346|Procedure|conventional empirical glycemic control|the patients' blood glucose is controlled by physician according to their experience through insulin subcutaneous injection or insulin continuous infusion whose dosage is determinated by the physician.
16054752|NCT02491346|Procedure|SGC directed glycemic control|the patients' blood glucose is controlled by SGC system through insulin continuous infusion whose dosage is determinated by SGC.
16054753|NCT02491333|Other|true acupuncture|True acupuncture treatment will be given three times per week. Each treatment session lasts for 30 minutes and can be separated by an interval of 1-3 days, with a maximum of 48 treatment sessions during 4 month.
16054754|NCT02491333|Other|sham acupuncture|Sham acupuncture treatment will be given three times per week. Each treatment session lasts for 30 minutes and can be separated by an interval of 1-3 days, with a maximum of 48 treatment sessions during 4 month.
16054755|NCT02491333|Drug|metformin|Metformin will be given at 0.5g/times, 3 times one day and for 4 month.
16054756|NCT02491333|Drug|Placebo metformin|Placebo metformin will be given at 0.5g/times, 3 times one day and for 4 month.
16054757|NCT02491320|Other|Pre-treatment acupuncture|Acupuncture treatment will start on day 3-5 after a spontaneous period or after a withdrawal bleeding following progestin. They will receive acupuncture treatment three times a week. Each treatment session lasts for 30 minutes and can be separated by an interval of 1-3 days, with a maximum of 48 treatment sessions during 16 weeks.
16054758|NCT02491320|Drug|Letrozole|Starting from 2.5mg daily from day 3-5 for 5 days after a spontaneous period or after a withdrawal bleeding following progestin, one time per day.Participants are treated for up to 4 cycles.
16054759|NCT02491307|Other|Ginger.io Smartphone Application|Daily use of the Ginger.io smartphone application
16054760|NCT02491294|Behavioral|School|students receive Cooking With Kids (CWK) - Colorado cooking & tasting lessons, SPARK active recess, and Cafeteria Connections
16054761|NCT02491294|Behavioral|Family|students receive the FFF family component - family nights, parent blog, and action packs that go home after each CWK-Colorado lesson
16054762|NCT02491294|Behavioral|About Eating|parents who completed the parent survey are invited to access the 6 lesson online About Eating program
16054763|NCT02491281|Drug|LNA043|ascending single dose on Day 1; 1 to 4 week(s) prior total knee replacement surgery
16054764|NCT02491281|Drug|Placebo|ascending single dose on Day 1; 1 to 4 week(s) prior total knee replacement surgery
16054765|NCT02491268|Drug|Cilostazol|
16054766|NCT02491268|Drug|Placebo|
16054767|NCT02491255|Device|Lotus Valve System|Device: Lotus Valve System
16054768|NCT02491242|Other|Dolutegravir in a dual therapy regimen|None. Patients initiating Dolutegravir-based dual therapy because of nucleoside analogues toxicity or intolerance will be followed up during a year
16055278|NCT02487628|Device|ULTRAPRO® Partially Absorbable Lightweight Mesh|
16054771|NCT02491216|Other|Acupressure|A 15 minutes structured acupressure protocol with specific acupoints and applications technique will be performed on the elderly participants twice a week by the research team in YCHSS Homes. Designated para-medical staffs working in the elderly home or informal care giver of the elderly will be trained and perform the same acupressure protocol on the elderly at 2 additional occasions during the week. The total trial period is 12 weeks.
16054772|NCT02491203|Other|Telerehabilitation system|Usual care plus home-based virtual reality telerehabilitation system.
16054773|NCT02491190|Behavioral|EMPOWER Educational Module|Evidence-based video module delivering content of the Right Question intervention from Deen et al. (2011)
16054774|NCT02491177|Behavioral|cMM|Home visits from community mentor mothers
16054775|NCT02491177|Behavioral|Text Messaging|Text messages received on mobile phone
16054776|NCT02491164|Other|BAC TWO|BAC TWO administration
16054777|NCT02491164|Device|FE and Cellvizio viewer software|Fibre based endomicroscopy to visualise fluorescent signal emitted by optical agents.
16054778|NCT02491138|Behavioral|Appearance-based intervention|
16054779|NCT02491138|Other|Pamphlets|
16054780|NCT02491125|Dietary Supplement|soluble wheat bran fibre|12 weeks daily intake of 15g of soluble wheat bran fibre
16054781|NCT02491125|Dietary Supplement|Placebo|12 weeks daily intake of 15g of maltodextrin
16054782|NCT02491099|Drug|Afatinib|Afatinib, 40 mg orally once daily on a 21 day cycle for the first 12 weeks, then every 28 days for subsequent cycles until progression
16054783|NCT02491086|Drug|Nicotine replacement therapy (NRT) sampling|1-week free NRT
16054784|NCT02491086|Behavioral|Smoking cessation counseling|Smoking cessation counseling
16054785|NCT02491073|Other|blood draw|Investigate the possibility of assay artifacts impacting the measurement of thyroid hormones, in particular FT4 and FT3, in ESL treated subjects compared to non-ESL-treated subjects.
16054786|NCT02491060|Drug|IDP-121 Lotion|Investigational Product: IDP-121 Lotion
16054787|NCT02491060|Drug|IDP-121 Vehicle Lotion|Comparator Product: IDP-121 Vehicle Lotion
16054788|NCT02491047|Device|BonyPid-1000|BonyPid-1000 implantation concomitantly to standard of care (SOC) treatment
16054789|NCT02491047|Other|Standard of Care (SOC) treatment|Standard of Care (SOC) treatment only
16054790|NCT02491034|Behavioral|Depression Education Intervention|Depression Education Intervention (DEI) designed to increase disease literacy, and dispel myths about depression and its treatment among Hispanic patients thus reducing stigma and increasing treatment engagement.
16054791|NCT02491021|Other|Rehabilitation Class|A 6 week programme of exercise and education in an out patient setting
16054792|NCT02491008|Drug|Levothyroxine|The intervention will start with Levothyroxine 50 mcg daily (reduced to 25 mcg in subjects <50 kg of body weight or if known coronary heart disease - previous myocardial infarction or symptoms of angina pectoris) vs. matching placebo; at 3 months, if the serum TSH level is <0.4 mU/L, dose will be reduced by 25 mcg; TSH >=0.4 and <4.6 mU/L, no change to dose; TSH >=4.6 mU/L, additional 25 mcg. The process will be repeated at 12 months, then annually; mock titration will be performed in the placebo group. The maximum possible dose of Levothyroxine which will be prescribed is 150 mcg (after 4 increments of 25 mcg at 3 months, 1, 2, 3 years; from the starting dose of 50 mcg).
16054793|NCT02491008|Drug|Placebo|"Control patients will obtain a placebo pill of the same characteristics as the intervention drug, and mock titration will be carried out identically to the intervention drug.
~Pharmaceutical composition of placebo (100 mg): Lactose monohydrate 66 mg, Maize starch 25 mg, Gelatin 5 mg, Croscarmellose sodium 3.5 mg, Magnesium stearate (vegetable source) 0.5 mg."
16054794|NCT02490995|Other|Movie|Besides the anesthesist explanations the children will have a movie explanation.
16054795|NCT02490982|Drug|Teriflunomide|The prescription of Teriflunomide administered orally as a 14mg daily compound to RRMS patients.
16054796|NCT02490969|Procedure|Routine management observation|Early rule out of myocardial infarction with combined copetine and troponin testing at admission
16054797|NCT02490956|Biological|Verorab® (PVRV; Purified Vero Cell Vaccine)|"Verorab® (PVRV; Purified Vero Cell Vaccine) 0.5 ml intramuscular
~Standard intramuscular regimen: ESSEN on days 0, 3, 7, 14, 28 and booster at 1 year later on days 360 and 363"
16054798|NCT02490943|Other|Warm Compress Before Injection|Receive warm compress before injection for three treatments, followed by cold compress after injection for three treatments.
16054799|NCT02490943|Other|Cold Compress After Injection|Receive cold compress after injection for three treatments followed by warm compress before injection for three treatments.
16054800|NCT02490930|Drug|Fingolimod|Oral fingolimod will be given 1 week prior to the initiation of concurrent radiation and temozolomide and will be discontinued immediately upon completion of the six weeks of therapy.
16054801|NCT02490917|Device|ACT™ device|Implantation of the Adjustable Continence Therapy device ACT®
16054802|NCT02490917|Device|AMS 800 ™ device|Implantation of the artificial urinary sphincter AMS 800 ™
16054803|NCT02490904|Drug|Eplerenone|Double-blinded Eplerenone administered for 4 days at 25mg every 12 hours
16054804|NCT02490904|Drug|Placebo|Double-blinded Placebo administered for 4 days at 25mg every 12 hours
16054805|NCT02490891|Device|RGD K5 PET scan|PET scan with a tracer specific for angiogenesis (RGD K5) will be performed before and after 2 cycles of chemotherapy
16054806|NCT02490878|Drug|bevacizumab|IV
16054807|NCT02490878|Drug|corticosteroids|IV
16054808|NCT02490878|Other|placebo|IV
16054809|NCT02490865|Drug|RNS60|RNS60, 4 ml dose nebulized twice daily
16054810|NCT02490865|Drug|Normal saline|Normal Saline, 4 ml dose nebulized twice daily
16054811|NCT02490852|Other|Investigational infant formula|fed ad libitum
16054812|NCT02490852|Other|Active Comparator: Commercially available Infant formula|fed ad libitum
16054813|NCT02490852|Other|Active Comparator: Human milk|fed ad libitum
16054814|NCT02490839|Drug|High-dose dual therapy (rabeprazole, amoxicillin)|High-dose dual therapy ( rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days)
16054815|NCT02490839|Drug|Bismuth-containing quadruple therapy (rabeprazole, tripotassium dicitrate bismuthate, metronidazole, tetracycline)|Bismuth-containing quadruple therapy (rabeprazole 20 mg bid + tripotassium dicitrate bismuthate 300 mg qid + metronidazole 250 mg qid + tetracycline 500 mg qid for 10 days)
16055279|NCT02487602|Device|Gelesis100|Gelesis100 capsules
16055280|NCT02487602|Other|Placebo|Sucrose (sugar) capsules
16054816|NCT02490826|Other|Table-based T2T intervention|"Phonological therapy consists of a combination of phonological awareness activities, auditory and discrimination and auditory bombardment activities. This activities will be based on table top materials. The items used in the intervention will be based on the child's target speech production goals. This intervention will include the following areas:
~Auditory Bombardment;
~Auditory and discrimination;
~Letter-sound knowledge;
~Phoneme identity and phoneme matching;
~Blending;
~Segmentation;
~Rhyme;
~Phoneme manipulation."
16054817|NCT02490826|Other|Tablet-based T2T intervention|"Phonological therapy consists of a combination of phonological awareness activities, auditory and discrimination and auditory bombardment activities. This activities will be based on digital materials presented on a tablet. The items used in the intervention will be based on the child's target speech production goals. This intervention will include the following areas:
~Auditory Bombardment;
~Auditory and discrimination;
~Letter-sound knowledge;
~Phoneme identity and phoneme matching;
~Blending;
~Segmentation;
~Rhyme;
~Phoneme manipulation."
16054818|NCT02490813|Dietary Supplement|Treatment - Chinese Herbal Formula - X|Wu Mei (Fructus Pruni Mume), Ling Zhi (Gonoderma), Huang Bai (Cortex Phellodendron), and Zhi Su (Perilla frutescens).
16054819|NCT02490813|Dietary Supplement|Placebo|Placebo will be starch with colorings
16054820|NCT02490800|Drug|Oral daily administration of BAL101553|oral administration
16054821|NCT02490787|Drug|Concizumab|Administered subcutaneously (s.c., under the skin) at five different dose levels (ranging from 0.25 to 1.5 mg/kg)
16054822|NCT02490787|Drug|placebo|Administered subcutaneously (s.c., under the skin)
16054823|NCT02490774|Drug|BAY1007626|Intrauterine device with 4 different in vitro release rates (low, low to medium, medium, high)
16054824|NCT02490774|Drug|Jaydess|Jaydess: Intrauterine device with a nominal in vitro release of 12 µg levonorgestrel/day
16054825|NCT02490774|Drug|Mirena|Mirena: Intrauterine device with a nominal in vitro release of 20 µg levonorgestrel/day
16054826|NCT02490748|Procedure|Radiofrequency ablation|Radiofrequency ablation is performed percutaneously under CT/US guidance
16054827|NCT02490748|Biological|Cytokine-induced killer cells|The patients received autologous cytokine-induced killer cells transfusion one week after RFA treatment.
16054828|NCT02490735|Biological|Cytokine-induced Killer Cells|chemotherapy plus 3 cycles of Cytokine-induced Killer Cells(CIK) treatment
16054829|NCT02490722|Other|Patient education|Four times two hours group based patient education
16054830|NCT02490709|Procedure|Local excision|Local excision for rectal cancer with good response
16054831|NCT02490696|Device|Miso PET scan|2 PET scans will be performed before surgery : the first one with F-Miso tracer and the second, 24 hours later, with FAZA tracer
16054832|NCT02490696|Device|FAZA PET scan|2 PET scans will be performed before surgery : the first one with FAZA tracer and the second, 24 hours later, with F-Miso tracer
16054833|NCT02490683|Dietary Supplement|Luna Rich X|
16054834|NCT02490683|Dietary Supplement|Placebo|Starch pill/or powder manufactured to mimic Luna Rich X and Reliv Now
16054835|NCT02490683|Dietary Supplement|Reliv Now|
16054836|NCT02490670|Drug|Cephalexin|Administered orally
16054837|NCT02490657|Drug|Inhaled iloprost|"Nebulized agents (Iloprost or normal saline) were randomized by computer-generated randomization. The patients and anesthesiologist, who administered inhalation and conducted all this trial, were blinded to the medication allocation. An anesthesiologist, who responsible for preparation of medication, was the only person recognizing of the randomization code during trial.
~Enrolled patients were received 20 μg iloprost or placebo (norma saline). Iloprost was diluted in normal saline to obtain 2ml solution. Control group were inhaled comparable dose of normal saline. Iloprost or normal saline was inhaled through an ultrasonic nebulized system in inspiratory limb."
16054838|NCT02490657|Drug|normal saline (Saline 0.9%)|
16054839|NCT02490644|Procedure|Blood sampling|Blood sampling 5ml
16054840|NCT02490631|Drug|2% chlorhexidine gluconate cloths|Cleansing twice pre-operatively jawline to toes with 2% chlorhexidine gluconate cloths
16054841|NCT02490618|Other|Probiotic tablet- Biogaia|
16054842|NCT02490618|Other|Placebo tablet|
16054843|NCT02490605|Procedure|occlusal plate group|occlusal plate with criteria for occlusal stability (simultaneous, bilateral contacts with an absence of interference in the canine and anterior guides
16054844|NCT02490605|Procedure|therapeutic exercises|"The exercise will consist of the movement of repeatedly opening the mouth with the tongue cleaving to the roof of the mouth 3 times per day with each period consists of of 3 sets with 15 repetitions"
16054845|NCT02490592|Other|Fluoride Foam|Fluoride foam - Flúor Care (NaF 1.23%) (G1)
16054846|NCT02490592|Other|Fluoride gel|Fluoride gel - Flugel FFA (NaF 1.23%) (G2)
16054847|NCT02490579|Behavioral|Responses to Brief Video Messages (Facebook)|Participants view 1 of 6 brief video messages about health in pregnancy, then answer survey questions that will assess their a) acceptability, b) understanding of core messages, and c) self-efficacy about healthy eating, exercise and weight gain during pregnancy.
16054848|NCT02490579|Behavioral|Response to Brief Video Messages (Clinic)|Participants view 1 of 6 brief video messages about health in pregnancy, then answer survey questions that will assess their a) acceptability, b) understanding of core messages, and c) who in her social network she turns to for non-clinical health advice and what kinds of advice she gotten in the past.
16054849|NCT02490579|Behavioral|Response to Brief Video Messages (Social Network)|Participants view 1 of 6 brief video messages about health in pregnancy, then answer survey questions that will assess their a) acceptability, b) understanding of core messages, and c) how they advise their pregnant friend about different health topics.
16054850|NCT02490566|Other|Telehealth|Tablet with chronic disease apps will be given to this group, apps will be focused on patient's condition. Follow-up visits will be conducted through video-conferencing.
16054851|NCT02490553|Other|heteroevaluation scale by a nurse or doctor|
16054852|NCT02490540|Drug|Sufentanil SPI analgesia|Sufentanil is given based on SPI value in the SPI guided analgesia group. The targer SPI range is set indiviudally based on the initial value of SPI recorded 5 minutes after the induction of anesthesia plus 10 points. In the ANI group, Sufentanil is given based on the ANI value, the target ANI range is 50 - 70. Values lower than 49 for 1 minute indicate the need of administering further dose of opioid, sufentanil is given in the same dose as initially. In the anesthesiologist guided analgesia group, Sufentanil is administered in a standardized manner.
16054853|NCT02490540|Drug|Sufentanil ANI analgesia|Sufentanil is given based on ANI analgesia monitor figures in the sufentanil ANI analgesia group. Targeted ANI range is 50 - 70. Figures lower than 49 for 1 minute indicate the need of administering further dose of opioid, sufentanil is given in the same dose as initially and flushed with 20 ml of saline. The next dose of opioid can be given in the earliest after 3 minutes interval, if indicated according to ANI monitoring. The doses are repeated up to achievement of the targeted range of analgesia (ANI). The last dose of opioid can be given no later than 15 minutes before the end of surgery.
16054854|NCT02490540|Drug|Sufentanil anesthesiologist analgesia|Sufentanil is given based on the anesthesiologist decision in the sufentanil anesthesiologist analgesia group. Sufentanil is administered in 20 minute intervals in a standardized manner, the same dose as initially is given and flushed with 20 ml of saline. Indication for additional administration of opioid beyond this interval is 25 % increase of systemic arterial pressure over the baseline and/or 35% increase of heart rate over the baseline. The next dose of opioid can be given in the earliest after 3 minutes interval. The doses are repeated up to achievement of the haemodynamic stability. The last dose of opioid can be given no later than 15 minutes before the end of surgery.
16054855|NCT02490527|Dietary Supplement|Pure epicatechin capsules (50mg)|Epicatechin is a compound found naturally in dark chocolate.
16054856|NCT02490527|Drug|Simvastatin (40mg)|A cholesterol-lowering medication that blocks the production of cholesterol.
16054857|NCT02490527|Other|Placebo|A substance that has no therapeutic effect and will act as a control.
16054858|NCT02490514|Other|No intervention|No intervention was administered in this study.
16054859|NCT02490501|Procedure|SC0806 and rehabilitation|
16054860|NCT02490501|Other|Rehabilitation only|
16054861|NCT02490488|Drug|Masitinib|
16054862|NCT02490488|Drug|Gemcitabine|
16054863|NCT02490488|Drug|Placebo|
16054864|NCT02490475|Drug|Docetaxel|Participants will receive docetaxel on Day 1 of each 3-week cycle as 60, 75, or 100 mg/m^2 via IV infusion. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal.
16054865|NCT02490475|Drug|RhuMab 2C4|Participants will receive rhuMab 2C4 on Day 1 of each 3-week cycle as 420 mg via IV infusion. For Cycle 1 ony, rhuMab will be administered on Day 2, at least 24 hours after docetaxel and following an initial 840-mg loading dose. Treatment may continue until disease progression, unacceptable toxicity, or consent withdrawal.
16054866|NCT02490462|Other|Education + Conventional PhysicalTherapy|The education program for parents will be held one day a week for 1 hour, with total duration of 12 weeks. During the parents or legal guardian meetings will be oriented to stimulate the drive to your child or ward during everyday activities such as bathing, dressing, eating, transferring, going to the bathroom. Parents will receive a diary to record the activities in the home environment. The orientation day for parents will take place in different days of the day the child will receive physical therapy, so that the physiotherapist responsible for the training of parents is shrouded in relation to the randomization of the subjects. This program will be associated with conventional physical therapy program that provides for movements based on neurodevelopmental concept.
16054867|NCT02490462|Other|Conventional Physical Therapy|The full program will be for 24 weeks, the first step will consist of 12 weeks of training with a frequency of twice a week should total at least 18 Conventional physical therapy interventions and 09 meetings of guidelines for parents. After this step be performed to start new reviews second step further 12 weeks with the same characteristics as the first 12 weeks. The conventional physiotherapy program will consist of functional muscle training focused on the task. Tasks will be individualized based on the results of the evaluations of Gross Motor Function and Inventory Pediatric Evaluation of Disability. The sessions will last 45 minutes carried out 2 times a week, training will have a total duration of 12 weeks.
16054868|NCT02490449|Drug|Dexlansoprazole MR|Administration of drug after or before diet
16054869|NCT02490436|Drug|Cetuximab|Randomized cross-over between cetuximab and placebo
16054870|NCT02490436|Drug|Placebo|Randomized cross-over between cetuximab and placebo
16054871|NCT02490423|Other|Nudges Intervention|The intervention arm will employ standard cardiovascular clinical care plus the combination of the MoBe Maps Patient Activation Platform with the Intermountain Risk Score to personalize and deliver motivational nudges to each participant.
16054872|NCT02490410|Dietary Supplement|protein supplement|
16054873|NCT02490397|Other|Day Light|Patients are exposed to day light for 2 weeks after a heart attack. At the end of 2 weeks they will have blood drawn.
16054874|NCT02490397|Other|Room Light|Patients will be exposed to only room or natural light for 2 weeks after heart attack. At the end of 2 weeks they will have blood drawn.
16054875|NCT02490384|Procedure|Physical exam indicated cerclage|Cervical cerclage
16054876|NCT02490371|Device|Low frequency rTMS|1 Hz low frequency rTMS over contra-lesional M1 region for 1200 pulse at 90% resting motor threshold for 10 sessions.Patients in the rTMS-ex group will receive the experimental rTMS A Magstim Rapid Stimulator (Magstim Company, Whitland, UK) equipped with an air-cooled figure-of-eight coil (each loop 70 mm in diameter) and neuro-navigation system will be used to deliver the intervention.
16054877|NCT02490371|Behavioral|structured physiotherapy upper limb training|Structural Physiotherapy upper limb training for 30-minutes
16054878|NCT02490345|Drug|gabapentin|gabapentin usage as adjunctive treatment for pain control
16054879|NCT02490345|Drug|Placebo|Identical placebo
16054880|NCT02490332|Device|Ventilation tube treatment|Tympanostomy
16054881|NCT02490306|Device|Strokefinder MD100 measurement|A microwave measurement will be performed with the patient lying in the hospital bed or another suitable surface. Follow-up microwave measurements will be performed after the acute phase.
16054882|NCT02490293|Drug|Cephalosporin|"During the hospitalization, intake of pacetin, 2nd generation cephalosporin. 3 g per day divided into 3 times via intravenous route until the day of discharge.
~After discharge, oral intakes of 500mg each (1 pill of cefaclor, the 2nd generation cephalosporin every 12 hrs) for three days."
16054883|NCT02490293|Drug|Placebo|"During the period of hospitalization, Intake of placebo (normal saline). 30cc per day divided into 3 times via intravenous route until the day of discharge.
~After discharge, oral intakes of 1000mg each (2 pill of vitamin C every 12 hrs) for three days."
16054884|NCT02490280|Behavioral|Trier Social Stress Test|The TSST is the gold standard social stress test and involves speaking in front of confederate judges and completing arithmetic tasks. The task takes 10-15 minutes.
16054887|NCT02490241|Drug|Lithium|Patients taking lithium as a mood stabilizer during pregnancy are eligible to participate in the study. Their dose and serum concentration levels of lithium will be monitored throughout pregnancy and up to three months postpartum.
16054888|NCT02490228|Procedure|TAURFUC|female patients with urethral caruncle will receive transurethral resection combine with extension tube.
16054889|NCT02490202|Drug|SANGUINATE|Two (2) infusions of 320 mg/kg of SANGUINATE at Baseline and Day 1
16054890|NCT02490202|Drug|Normal Saline|Two (2) infusions of Normal Saline at an equal volume to SANGUINATE at Baseline and Day 1.
16054891|NCT02490189|Behavioral|Mindfulness-based Intervention|Twelve week group intervention that includes training in mindfulness meditation, self-compassion and mindful exposure.
16054892|NCT02490189|Behavioral|Cognitive Behavior Group Therapy|Twelve week group intervention that focuses on the interaction between thoughts, feelings, and behaviors.
16054893|NCT02490176|Drug|liraglutide|Liraglutide were taken daily for 7 days
16054894|NCT02490176|Drug|placebo|Placebo were taken daily for 7 days
16054895|NCT02490163|Device|Spectra Optia|"The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself, 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software.
~Terumo BCT developed a completely automated apheresis system: the Spectra Optia MNC and CMNC based on an automatic interface-controlled technology that allows MNCs collection without the intervention of an operator. The optical sensors continuously control and adjust the buffy coat layer by adjusting the plasma flow.
~The Spectra Optia MNC collects MNCs by intermittent flow: MNCs accumulate and are flushed from a secondary chamber at intervals during the procedure. On the other hand, the very recently released Spectra Optia CMNC (developed especially to collect stem cells that reside in the MNCs layer) is able to collect MNCs by continuous flow."
16054896|NCT02490150|Drug|Corifollitropin alfa|
16054897|NCT02490137|Behavioral|Race Car Video Game|Repeatedly playing a race car video game
16054898|NCT02490111|Drug|DWJ1319|
16054899|NCT02490111|Drug|Placebo|
16054900|NCT02490098|Other|6-day intervention with sensor-augmented pump therapy|One day prior to the intervention, participants will have to install a glucose sensor and the study insulin pump. Participants will adjust their insulin delivery as per their standard practice; including temporary basal and correction boluses. Participants will have access to their finger-stick glucose measurements and will be advised to measure their glucose level as per their standard practice. Participants will be asked to install a new infusion set every 2 days. Participants will be allowed to eat whatever they want and allowed to drink alcohol. Participants will use sensor-augmented pump therapy for 6 days.
16054901|NCT02490098|Other|6-day intervention with single-hormone closed-loop strategy|One day prior to the intervention, participants will have to install a glucose sensor and the study insulin pump. On the first day of the intervention, participants will be admitted to the clinical research facility in the morning. A team member will review with the participant how to use study devices. Competency on the use of study devices will be assessed by a team member. Only participants demonstrating competency on use of study devices will be allowed to continue to the home study phase. Participants will be allowed to go home in the afternoon. They will be advised to continue with study intervention at home for the next 5 days. Participants will be asked to install a new infusion set every 2 days. Participants will be allowed to eat whatever they want and allowed to drink alcohol.
16054902|NCT02490098|Other|6-day intervention with dual-hormone closed-loop strategy|One day prior to the intervention, participants will have to install a glucose sensor and the study insulin pump. On the first day of the intervention, participants will be admitted to the clinical research facility in the morning. Participants will have to install a second pump containing glucagon. A team member will review with the participant how to use study devices. Competency on the use of study devices will be assessed by a team member. Only participants demonstrating competency on use of study devices will be allowed to continue to the home study phase. Participants will be allowed to go home in the afternoon. They will be advised to continue with study intervention at home for the next 5 days. Participants will be asked to install a new infusion set every 2 days. Participants will be allowed to eat whatever they want and allowed to drink alcohol.
16054903|NCT02490098|Drug|Insulin|Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)
16054904|NCT02490098|Drug|Glucagon|Glucagon (Eli Lilly) will be used during dual-hormone closed-loop strategy.
16054905|NCT02490098|Device|Continuous Glucose Monitoring System Enlite sensor®, Medtronic|Enlite sensor®, Medtronic
16054906|NCT02490098|Device|Insulin pump MiniMed® Paradigm® Veo™, Medtronic|MiniMed® Paradigm® Veo™, Medtronic
16054907|NCT02490085|Other|24-hour intervention with multiple daily injections|Subjects will be admitted at the research clinical facility at 20:00. A cannula will be inserted into an arm or a hand vein for blood sampling purposes. The subjects will carry on with their normal insulin therapy. Two periods of walking of 15 minutes will be performed at 10:00 and 15:00. Meals will be served at 8:00, 12:00 and 17:00. The CHO content of meals will be adapted to subject's usual CHO intake. Venous blood samples (4 ml each) will be obtained for the measurement of the plasma glucose and insulin. Plasma glucagon and C-peptide will be measured every hour. Blood samples will be drawn every 20 minutes.
16054908|NCT02490085|Other|24-hour intervention with closed-loop strategy|Subjects will be admitted at the research clinical facility at 20:00. A cannula will be inserted into an arm or a hand vein for blood sampling purposes. A cartridge containing subject's usual fast acting insulin analog will be placed in the insulin pump. Closed-loop strategy will start at 21:00 until 21:00 the next day. Neither basal nor prandial insulin injections will be given. Two periods of walking of 15 minutes will be performed at 10:00 and 15:00. Meals will be served at 8:00, 12:00 and 17:00. The CHO content of meals will be adapted to subject's usual CHO intake. Venous blood samples (4 ml each) will be obtained for the measurement of the plasma glucose and insulin. Plasma glucagon and C-peptide will be measured every hour. Blood samples will be drawn every 20 minutes.
16054909|NCT02490085|Drug|Insulin|Subject's usual insulin analog will be used.
16054910|NCT02490085|Device|Insulin pump Accu-Chek Combo|During closed-loop intervention, the Accu-Chek Combo (Roche) insulin pump will be used
16054911|NCT02490085|Device|Dexcom G4 Platinum|In both visits, glucose levels will be measure with the Dexcom G4 Platinum (Dexcom)
16055756|NCT02484378|Drug|Placebo|Normal saline
16054912|NCT02490072|Drug|Dexmedetomidine|Formula for administrated were randomized by computer-generated randomization. The patients and anesthesiologist, who administered and conducted all this trial, were blinded to the medication allocation. An anesthesiologist, who responsible for preparation of medication was the only person, recognized of the randomization code during trial. 10 minutes after anesthetic induction, dexmedetomidine group would start the loading of dexmedetomidine (1μg/kg) during 10 minutes followed infusion of dexmedetomidine(0.5 μg/kg/min). Bispectral index was monitored continuously targeting 40±5. Target concentration of remifentanil and fresofol were controlled stepwise in accordance with BIS. Using the transesophageal echocardiography, we will evaluate the changes of cardiac function including Tei index and cardiac output.
16054913|NCT02490072|Drug|normal saline(Saline 0.9%)|
16054914|NCT02490059|Other|bronchoscopy|Bronchoscopy for diagnosis of pulmonary nodules
16054915|NCT02490046|Dietary Supplement|D Mannose|Patients in both arms will receive D-mannose powder to be used 1.5 gm (one level-teaspoon) twice daily, to be added to any beverage, for 16 weeks.
16054916|NCT02490033|Device|Ablation Catheter|
16054917|NCT02490020|Biological|mesenchymal stem cell|
16054918|NCT02489994|Device|ePrime|The main intent of the ePrime for cellulite is to utilize a minimally-invasive approach to directly deliver RF energy into tissue through pairs of micro-electrode needles and use temperature sensors within the needles to reliably create fractional thermal injuries within the skin.
16054919|NCT02489981|Drug|Spiriva|60 puffs
16054920|NCT02489968|Drug|empagliflozin 10 mg + linagliptin 5 mg|empagliflozin low dose + linagliptin once daily
16054921|NCT02489968|Drug|empagliflozin 10 mg|empagliflozin low dose once daily
16054922|NCT02489968|Drug|empagliflozin 25 mg + linagliptin 5 mg|empagliflozin high dose + linagliptin once daily
16054923|NCT02489968|Drug|empagliflozin 25 mg|empagliflozin high dose once daily
16054924|NCT02489968|Drug|Placebo|
16054925|NCT02489955|Drug|Amikacin|
16054926|NCT02489955|Drug|Tobramycin|
16054927|NCT02489955|Drug|Colomycin|
16054928|NCT02489942|Drug|Jardiance|Empagliflozin
16054929|NCT02489929|Other|blood samples|This clinical study aims at correlating the values in CDA levels with the risk of drug-related toxicities and to the clinical response to azacytidine treatment for patient suffering of MDS or Myeloid leukemia
16054930|NCT02489929|Drug|azacytidine|
16054931|NCT02489916|Drug|CM4307|CM4307 300mg bid, each 4 week cycle
16054932|NCT02489903|Drug|RRx-001|
16054933|NCT02489903|Drug|Cisplatin|
16054934|NCT02489903|Drug|Etoposide|
16054935|NCT02489903|Drug|Carboplatin|
16054936|NCT02489903|Drug|Irinotecan|
16054937|NCT02489903|Drug|Vinorelbine|
16054938|NCT02489903|Drug|Doxil|
16054939|NCT02489903|Drug|Gemcitabine|
16054940|NCT02489903|Drug|Taxane|
16054941|NCT02489903|Drug|Paclitaxel|
16054942|NCT02489903|Drug|Nab-Paclitaxel|
16054943|NCT02489903|Drug|Pemetrexed|
16054944|NCT02489890|Biological|Cytokine-induced Killer Cells|chemotherapy plus 3 cycles of Cytokine-induced Killer Cells(CIK) treatment
16054945|NCT02489864|Drug|Terlipressin|
16054946|NCT02489851|Procedure|Quadratus Lumborum block|0.2 ml/kg bupivicaine 0.125% injected bilateraly at the posterior border of the quadratus Lumborum muscle
16054947|NCT02489851|Procedure|Tranversus Abdominis plane block|0.2 ml/kg bupivicaine 0.125% injected bilateraly between internal oblique and transversus abdominis muscles.
16054948|NCT02489825|Procedure|Augmentation vertebroplasty|Cement augmentation of fractured vertebral body
16054949|NCT02489825|Procedure|Augmentation and prophylactic vertebroplasty|Cement augmentation of fractured vertebral body and prophylactic augmentation of both adjacent vertebral bodies
16054950|NCT02489812|Behavioral|Music|This cross over trial aimed to analyze the use of music as a distraction resource during children dental treatment, evaluating their cardiac and respiratory frequency. Thirty-four children took part in this study, 16 boys and 18 girls, from 4 to 6 years old, with no previous dental experience, who had two carious lesions on occlusal surfaces of molars,
16054951|NCT02489799|Behavioral|Advance care planning video|This is a video involving interviews with patients, a family member, two surgeons, an anesthesiologist, and an ICU nurse; these interviewees describe the typical events during a hospitalization for a major surgery and encourage the viewer to do some planning before surgery - the planning includes: (i) naming a person to make decisions for the participant, (ii) having a conversation with that person about goals and values, and (iii) continuing that conversation with the participant's surgeon.
16054952|NCT02489799|Behavioral|Control video|This is a video showing the history of The Johns Hopkins Hospital and emphasizing that The Johns Hopkins Hospital is a great place to receive medical care.
16054953|NCT02489786|Drug|patients take 0.25 mg of digoxin daily except friday|
16054954|NCT02489786|Drug|patients take 0.25 mg of digoxin daily except thursday and friday|
16054955|NCT02489786|Drug|patients take 0.125 mg of digoxin daily|
16054956|NCT02489786|Drug|digoxin dose is calculated using Jusko-Koup method and given daily|
16054957|NCT02489760|Biological|Adalimumab|The treatment arm will receive adalimumab 40 mg subcutaneously biweekly
16054958|NCT02489760|Biological|Etanercept|The control arm will continue etanercept 25 mg subcutaneously twice a week
16054959|NCT02489747|Dietary Supplement|WBE|wheat bran extract (3 g/day)
16054960|NCT02489747|Dietary Supplement|Placebo|Placebo
16054961|NCT02489734|Drug|sevoflurane|extubation when end-tidal concentration of sevoflurane < 0.5%
16054962|NCT02489734|Drug|Sevoflurane|extubation when end-tidal concentration of sevoflurane >= 0.5%
16054963|NCT02489721|Device|PICC and Midline|Peripherally inserted central venous catheter
16054964|NCT02489708|Behavioral|Cessation Counseling|Nurses will be trained to use Electronic Medical Record system to counsel families about second hand smoke exposure. Saliva samples will be obtained from 15 children at baseline and at follow-up to explore the effects of the nurse intervention.
16054965|NCT02489695|Drug|axitinib|
16054966|NCT02489682|Other|Long-form written Informed consent information|
16054967|NCT02489682|Other|Short-form written Informed consent information|
16054968|NCT02489682|Other|Video Informed consent information|
16056069|NCT02482129|Drug|LME636 60 mg/mL ophthalmic solution|
16054969|NCT02489669|Device|RenalGuard system™® (PLC Medical Systems, Inc. Franklin, MA, USA)|Patients in the RenalGuard group will be treated by hydration with normal saline controlled by the RenalGuard system™® (PLC Medical Systems, Inc. Franklin, MA, USA). The RenalGuard system includes a) a closed loop fluid management system; b) a high volume fluid pump, c) a high accuracy dual weight measuring system; d) motion detection artifact reduction; e) a single use intravenous set and urine collection system that interfaces with a standard Foley catheter; f) real-time display of urine and replacement fluid volume; g) a timely alerts to drain the urine bag or to replace the hydration fluid bag; f) and safety features such as automatic air and occlusion detection.
16054970|NCT02489656|Device|Double Loop Ureteral stent endoscopic placement.|A JJ stent placement may be indicated at the end of the endourological removal of kidney stones to ensure urine drainage and cicatrisation
16054971|NCT02489643|Procedure|Individualized practical training|
16054972|NCT02489630|Drug|Ketamine|0.1mg/kg ketamine IV
16054973|NCT02489630|Drug|Normal Saline|1ml/kg normal saline placebo
16054974|NCT02489630|Drug|opiate analgesic|0.1mg/kg dose of morphine (or morphine equivalent) at 30 min time intervals based on patient pain score or more frequently upon request
16054975|NCT02489617|Other|Pathologic evaluation of excised tissue|Up to 3 months after excisional biopsy
16054976|NCT02489604|Drug|177Lu-DOTATATE 25.9 GBq activity|177Lu-DOTATATE will be administered in a 30 minutes infusion. Total activity of 25.9 GBq 100 mCi for 7 cycles every 6 ± 2 weeks (700 mCi)
16054977|NCT02489604|Drug|177Lu-DOTATATE 18.5 GBq activity|177Lu-DOTATATE will be administered in a 30 minutes infusion Total activity of 18.5 GBq 100 mCi for 5 cycles , every 6 ± 2 weeks (500 mCi)
16054978|NCT02489591|Device|Oral appliance|Patients will bring their prescribed oral appliance.
16054979|NCT02489591|Device|BluePro oral appliance|Patients without a prescribed oral appliance will have a device provided for the duration of the study (BluePro, BlueSom; used for investigational purposes only). The device provided is a prefabricated thermoplastic customizable mandibular advancement splint.
16054980|NCT02489578|Other|other|retrospective cohort study
16054981|NCT02489565|Other|Telemedicine|Outpatient discharge from tertiary care to primary care with a letter of referral explaining about the study containing phone number from telemedicine and a letter with the patient's history in the hospital. Two months after discharge, the telemedicine's cardiologist initiates contact with the primary care's physician about patient follow-up.
16054982|NCT02489539|Device|GORE® EXCLUDER® Conformable AAA Endoprosthesis|Endovascular Aneurysm repair (EVAR) is a minimally invasive procedure designed to exclude an aneurysmal segment of the aorta from blood circulation. The EVAR procedure involves delivery of a stent- graft compressed onto a catheter to an aneurysmal segment of the aorta from a remote access site, generally the femoral artery. Arterial access may be done by either percutaneous or cut-down technique.
16054983|NCT02489526|Drug|VVZ-149 Injections|Experimental group will receive a loading dose of 1.8 mg/kg VVZ-149 intravenous infusion for 0.5 hour followed by a maintenance dose of 1.3 mg/kg/h VVZ-149 intravenous infusion for 7.5 hours.
16054984|NCT02489526|Drug|Placebo|Placebo group will receive the corresponding amount of placebo.
16054985|NCT02489513|Drug|[14C]-AG-120|Labeled investigational drug
16054986|NCT02489500|Drug|Bortezomib|"Conditioning Regimen:
~Drug: Bortezomib: 1.0 mg/m2/dose D -6, D -3, D +1, D + 4 Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1"
16054987|NCT02489500|Drug|Melphalan|"Conditioning Regimen:
~Drug: Melphalan: 70-100 mg/m2/dose D -2, D -1 Stem Cell Transplant: D 0"
16054988|NCT02489500|Drug|Neupogen|granulocyte colony-stimulating factor (G-CSF) mobilization 16mcg/kg x 4 days
16054989|NCT02489500|Procedure|Stem Cell Collection|collect at least 2.5 million cluster of differentiation 34 (CD34)+ stem cells
16054990|NCT02489500|Procedure|Stem cell infusion|infusion of previously collected autologous stem cells
16054991|NCT02489487|Drug|VM-1500|VM-1500 40 mg
16054992|NCT02489487|Drug|Darunavir|Darunavir 600 mg
16054993|NCT02489487|Drug|Ritonavir|Ritonavir 100 mg
16054994|NCT02489487|Drug|Raltegravir|400 mg Raltegravir
16054995|NCT02489461|Drug|VM-1500|VM-1500 up to 96 weeks
16054996|NCT02489461|Drug|Efavirenz|Efavirenz up to 48 weeks
16054997|NCT02489461|Drug|Antiretroviral therapy (ART)|Antiretroviral therapy up to 96 weeks
16054998|NCT02489448|Drug|MEDI4736|"The investigational product is MEDI4736 which will be supplied in glass vials containing 500 mg of liquid solution at a concentration of 50 mg/mL for intravenous (IV) administration.
~Routine, standard of care chemotherapy will be given together with the investigational product and will include weekly nab-paclitaxel x12 treatments followed by every two-week doxorubicin, cyclophosphamide (ddAC) x 4 treatments."
16054999|NCT02489435|Drug|VM-1500|VM-1500
16055000|NCT02489435|Drug|Placebo|Placebo
16055001|NCT02489422|Other|Laboratory Biomarker Analysis|Correlative studies
16055002|NCT02489422|Other|Questionnaire Administration|Ancillary studies
16055003|NCT02489422|Other|Daily Survey Administration|Ancillary studies
16055004|NCT02489422|Behavioral|Yoga Skills Training|The YST intervention consists of four 30 minute in-person sessions that instructs skills to enhance mindfulness and promote relaxation. Participants will also be encouraged to practice daily at home.
16055005|NCT02489422|Behavioral|Attention Control|The AC intervention consists of four 30 minute in-person sessions of supportive conversation. In addition, the interventionist will recommend that the patients write brief diary entries daily at home.
16055006|NCT02489422|Other|Actigraphy Assessment|Ancillary studies
16055007|NCT02489409|Drug|EndostarTM Injection|210 mg in 279 mL normal saline (NS), continuous pump, d1-d10 (2.5 mL/h)
16055008|NCT02489409|Drug|Gemcitabine|1.0 m/m2, iv 0.5h, d1, 8
16055009|NCT02489409|Drug|Navelbine|40 mg/d, iv, d1, 8
16055010|NCT02489409|Drug|Platinum|30 mg/m2, iv 3h, d1-3
16055011|NCT02489409|Drug|Xeloda Tablets:|2 000 mg/m2, po, d1-14
16055042|NCT02489188|Procedure|arthroplasty|patients, who are scheduled for arthroplasty, will be measured before and on average 6 months after surgery
16055043|NCT02489188|Other|manual therapy|patients, who are scheduled for manual therapy, will be measured before, immediately and on average 1 week after treatment
16055044|NCT02489188|Procedure|lumbar spinal stenosis decompression|patients, who are scheduled for lumbar spinal stenosis decompression, will be measured before and on average 6 months after surgery
16055012|NCT02489396|Behavioral|Nutrition facts automatically or not automatically displayed|"For two months nutrition information on the Rosie site will be displayed in a tab that consumers can click on to display the nutrition facts panels of products. Investigators will use NuVal scores to determine the fifteen healthiest, and fifteen least healthy items in six grocery categories; chips, cookies, cereal & breakfast, yogurt, ice cream, and frozen pizza. We will then compare the number of clicks on nutrition information for healthier versus less healthy items to determine if there's a possibility of willful ignorance coming into play when choosing to purchase less healthy items."
16055013|NCT02489396|Behavioral|Nutrition facts in color|For two months the font on products' nutrition facts labels will be displayed in red or green. For this proof-of-concept intervention, the color of a label's display will be determined randomly, in order to gather a clearer picture of whether label color could be leveraged to influence product choice. Items in each grocery category will be randomly assigned to receive green or red labels during the intervention period, so 50% of products in each category have red nutrition facts labels, and 50% have green nutrition facts labels. We will then compare proportions of green to red items purchased during the intervention period with the proportion of those same items purchased during the baseline period, when all labels were in black font.
16055014|NCT02489396|Behavioral|Nutrition Facts Label in Larger Font|For two months the serving size and calorie lines on the nutrition facts labels will be displayed in a larger font for every item on the Rosie site. Average calories in customer purchases will be quantified using purchase data, and the average calories for online-grocery orders during baseline and intervention periods will be compared.
16055015|NCT02489396|Behavioral|Healthier Items First|For two months, instead of the product popularity default-display option in the online store, thirty healthier items will be displayed on the first page in each grocery category. All grocery categories where there is scoring variation between healthy and less-healthy options (i.e. cereal, chips, bakery, sauces, etc.) will be included in the intervention. The thirty-targeted healthy items will be identified using NuVal scores. NuVal scores will not actually be displayed as part of the shopping site, and will be used exclusively as a guide to systematically determine targeted items in each food category. The proportion of targeted healthy items purchased in each category versus non-targeted items purchased during the intervention will be compared to the proportion of targeted vs. non-targeted items purchased during the baseline period.
16055016|NCT02489383|Other|Continuous Exercise Training|The continuous training (CT) will be held in two weekly sessions lasting total of 40 minutes and 5 minutes for heating and 5 to slowdown, and the duration will be 24 sessions (3 months). The exercise sessions will be will be performed on a stationary bicycle, with the initial intensity of 70% of VO2max. If the subject sustain continuously training intensity for 2 consecutive sessions without symptoms breathing, exercise intensity will be increased by 5% of heart rate. The patient may stop the activity if he has any symptoms or respiratory distress, returning it as soon present improvement. Throughout the training, will be monitored heart rate and the level of perception subjective effort (modified Borg scale).
16055017|NCT02489383|Other|Interval Exercise Training|The interval training (IT) will be held in two weekly sessions. The IT is individualized and will be performed on a stationary bicycle. Training sessions will be performed with total duration of 40 minutes consisting of 5 minutes extender, 30 minutes from the main part (IT), finishing with five minutes back to calm. In the main part (of 5 to 30 minutes), the patient will perform the exercise with high intensity in the first two weeks, the exercise will be conducted with an intensity 80% of maximum capacity obtained in cycle ergometer test and will cycle for 30 seconds followed by a 30 second recovery period. In the 3rd and 4th weeks, the intensity will be increased to 100% of the maximum obtained. After this period, the intensity will be increased by 5% charge.
16055018|NCT02489383|Behavioral|Education Program|The education program will discuss issues related to asthma and physical activity. Presentations and group discussions will be carried out, including information about asthma pathophysiology, medication and peak flow meter skills, self-monitoring techniques, environmental control, benefits and current recommendations of physical activity.
16055019|NCT02489370|Device|Home telemonitoring|The intervention consists of daily monitoring the patients' weight and blood pressure directly from their home; automatically and securely transmit the values to a server at the hospital; and monitor the values by a trained nurse at the Heart polyclinic.
16055020|NCT02489357|Procedure|Cryosurgery|Undergo whole gland cryoablation
16055021|NCT02489357|Drug|Degarelix|Given SC
16055022|NCT02489357|Other|Laboratory Biomarker Analysis|Correlative studies
16055023|NCT02489357|Biological|Pembrolizumab|Given IV
16055024|NCT02489344|Drug|GZ/SAR402671|"Pharmaceutical form:capsule
~Route of administration: oral"
16055025|NCT02489318|Drug|Apalutamide|Participants will receive apalutamide 240 mg (4 x 60 mg) tablets orally once daily in each 28 day treatment cycles.
16055026|NCT02489318|Drug|Placebo|Participants will receive Placebo orally once daily in each 28 day treatment cycles.
16055027|NCT02489318|Drug|Androgen Deprivation Therapy (ADT)|All participants will receive and remain on a stable regimen of ADT (gonadotropin releasing hormone analog [GnRHa] or surgical castration). The choice of the GnRHa (agonist or antagonist) will be at discretion of the Investigator. Dosing (dose and frequency of administration) will be consistent with the prescribing information.
16055028|NCT02489292|Biological|HepaStem|HepaStem will be administered in maximum 4 infusion days, spread over an 8-week period with an interval of 2 to 3 weeks between infusion days. The target total dose of cells will be 50x10E6 cells/kg body weight
16055029|NCT02489279|Behavioral|Sustained Attention Control (SAC) Method|Participants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks.
16055030|NCT02489279|Behavioral|Scrabble|Participants use the software for 5 minutes, 3 times per day, 5 days per week, for 10 weeks.
16055031|NCT02489266|Biological|AKTi-treated TIL|On day 0, cells will be infused intravenously (IV) over 20-30 minutes (between 1 and 4 days after the last dose of fludarabine).
16055032|NCT02489266|Drug|Cyclophosphamide|Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days.
16055033|NCT02489266|Drug|Fludarabine|Patients will receive Fludarabine 25 mg/m2/day for 5 days.
16055034|NCT02489266|Drug|Aldesleukin|Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
16055035|NCT02489253|Other|CT coronary angiogram and carotid ultrasound|Scans in addition to routine clinical care
16055045|NCT02489175|Device|Stomaplasty KoringTM|In these patients, the stomaplasty Koring will be implanted at the time of the primary definitive stoma creation. The implantation of the Koring will be performed by experienced surgeons (expertise based, best team approach) who have already implanted the Koring (e.g. participated in the observational study) and/or have reviewed the video documentation. To ensure standardization for all participating centres an operative manual with standardized video sequences is available.
16055046|NCT02489162|Device|MyotonPRO|MyotonPRO measurements of the biomechanical properties of facial mimic muscles
16055047|NCT02489162|Device|non-invasive electromyography (EMG)|Gold standard technique for measuring muscle
16055048|NCT02489149|Other|Multi-sector interventions|"Multi-sector interventions to enhance food security: Agricultural interventions are matched with field training for government sectors working with quilombolas communities on best agronomic practices to promote technical assistance for this communities. Stimulate the participation in the Program of Food Acquisition, supporting quilombolas agriculture.
~For quilombolas participants: nutritional counseling based on traditional healthy cooking practices, using traditional recipes.
~For health professionals: to strengthen food and nutrition actions at all levels of health care. Food and nutritional education training for primary care health professionals.
~Helping families to have more knowledge about your citizen rights."
16055049|NCT02489149|Other|Control|Placebo Comparator: Conventional approach of current public food and nutrition policies.
16055050|NCT02489136|Other|"laying of hands (Spiritist passe)"|In a distance of 10 cm and to apply the spiritist passe for 10 minutes.
16055051|NCT02489123|Drug|Enzalutamide|Given PO
16055052|NCT02489123|Other|Laboratory Biomarker Analysis|Correlative studies
16055053|NCT02489110|Behavioral|Webnovela|
16055054|NCT02489110|Behavioral|Information|
16055055|NCT02489097|Drug|Nitrous Oxide|Administration of a concentration of 70% Nitrous Oxide with 30% Oxygen in the anaesthetic gas mixture
16055056|NCT02489097|Other|Placebo|Administration of a concentration of 70% Air with 30% Oxygen in the anaesthetic gas mixture
16055057|NCT02489084|Other|Blood sampling|
16055058|NCT02489071|Behavioral|Brain Training Program|
16055059|NCT02489071|Behavioral|Brain Health Program|
16055060|NCT02489045|Drug|SHAPE measurement (Sonazoid ultrasoud contrast agent)|Three vials with 48 µl of Sonazoid (GE Healthcare, Oslo, Norway) microbubbles (6 ml) will be prepared and drawn into a 10 ml syringe, placed in a syringe pump. Sonazoid will be co-infused at a rate of 0.024 µl/kg body weight/minute (suspension infusion rate of 0.18 ml/kg/hour) together with a 0.9% NaCl solution infused at a rate of at least 2 ml/min.
16055061|NCT02489032|Behavioral|SBIRT Training & Support Tool|Program to train EAP/behavioral health practitioners in conducting alcohol SBIRT
16055062|NCT02489032|Other|Waitlist Control|3-month wait-list and then provided access to the SBIRT training program
16055063|NCT02489019|Drug|Sodium chloride|Sodium chloride will be used as a placebo comparator in this trial
16055064|NCT02489019|Drug|Fentanyl|Fentanyl is a synthetic opioid analgesic that will be used as the experimental intervention in this trial
16055065|NCT02489006|Drug|Olaparib|
16055066|NCT02489006|Drug|Platinum-based Chemotherapy|Chosen by the study doctor, per standard of care.
16055067|NCT02488993|Other|Prospective Phase Rifaximin-α 550mg|Prospective data collection of all patients receiving rifaximin-α 550 mg from the point of study entry.
16055068|NCT02488993|Other|Prospective Phase No Rifaximin-α 550mg|Prospective data collection of all patients not receiving rifaximin-α 550 mg from the point of study entry.
16055069|NCT02488993|Other|Retrospective Phase|Review of medical records and electronic hospital admissions data for patients with HE who have not received rifaximin-α 550 mg during the previous 12 months.
16055070|NCT02488980|Drug|Tafenoquine|Tafenoquine 200 mg for three days followed by Tafenoquine 200 mg once a week for 24 weeks.
16055071|NCT02488980|Drug|Mefloquine|Mefloquine 250 mg for three days followed by Mefloquine 250 mg once a week for 24 weeks.
16055072|NCT02488980|Drug|Placebo|Placebo for three days followed by placebo once a week for 24 weeks
16055073|NCT02488967|Drug|Carboplatin|Given IV
16055074|NCT02488967|Drug|Cyclophosphamide|Given IV
16055075|NCT02488967|Drug|Doxorubicin Hydrochloride|Given IV
16055076|NCT02488967|Other|Laboratory Biomarker Analysis|Correlative studies
16055077|NCT02488967|Drug|Paclitaxel|Given IV
16055078|NCT02488954|Other|Probiotics in the form of cheese portion|
16055079|NCT02488915|Device|EmboTrap® Revascularization Device|
16055080|NCT02488902|Drug|Placebo|Placebo
16055081|NCT02488902|Drug|Tafenoquine 25mg|Tafenoquine 25mg
16055082|NCT02488902|Drug|Tafenoquine 50mg|Tafenoquine 50mg
16055083|NCT02488902|Drug|Tafenoquine 100 mg|Tafenoquine 100 mg
16055084|NCT02488902|Drug|Tafenoquine 200 mg|Tafenoquine 200 mg
16055085|NCT02488902|Drug|Mefloquine 250 mg|Mefloquine 250 mg
16055086|NCT02488889|Drug|Varenicline|
16055087|NCT02488889|Drug|Placebo pill (for varenicline)|
16055088|NCT02488889|Drug|Alcohol|
16055089|NCT02488889|Drug|placebo beverage (for alcohol)|
16055090|NCT02488863|Other|MRI Neuroimaging|MRI scans utilized to measure the structural and functional integrity of the brain.
16055091|NCT02488863|Other|Quantitative Sensory Testing|Vibratory Detection Thresholds; Tactile Detection Thresholds; Thermal Detection Thresholds, Pain Thresholds, and Temporal Summation; Allodynia and Temporal Summation; Punctate Pain Testing and Temporal Summation; and Pressure Pain Thresholds.
16055092|NCT02488863|Other|Questionnaires|The Modified Mini-Mental State Examination (3MS), the Montreal Cognitive Assessment (MoCA), the Center for Epidemiologic Studies Depression Scale (CES-D), the Geriatric Depression Scale (GDS), the Edinburg Handedness Inventory, the Ten-Item Personality Inventory (TIPI), the Pittsburgh Sleep Quality Index (PSQI), the state and trait versions of the State-Trait Anxiety Inventory (STAI), the state and trait versions of the Positive and Negative Affect Schedule (PANAS), pain questionnaires (the Graded Chronic Pain Scale (GCPS), the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Pain-Detect, the short-form McGill Pain Questionnaire (SF-MPQ-2), and the Coping Strategies Questionnaire-Revised (CSQ-R)), a standardized paper and pencil cognitive battery (Hopkins Verbal Learning Test (HVLT), Trail Making A&B, Boston Naming Test, Controlled Oral Word Association Test (COWAT), Stroop Interference Test, Ruff Figural Fluency Test, and Raven's Progressive Matrices Test).
16055093|NCT02488863|Other|Physical and Cognitive Function Testing|Upper Limb Isometric Strength, Short Physical Performance Battery (SPPB), GAITRite Instrumented Walking, Galvanic Skin Response, Knee Extension Isokinetic Strength, the Pepper Assessment Tool for Disability (PAT-D), and an electronic NIH Toolbox Cognitive Battery.
16055094|NCT02488850|Procedure|Surgery|
16055095|NCT02488850|Radiation|SABR|
16055096|NCT02488824|Procedure|Warm Temperature|Subjects will be exposed to a routinely encountered warm temperature (95 F) for up to to 2 hours, depending on their vital signs (BP, HR, Tcore) and tolerance (comfort).
16055097|NCT02488798|Procedure|2D grey scale vaginal ultrasound|To assess the endometrial thickness and echogenicity (whether the endometrium is uniform or non-uniform).
16055098|NCT02488798|Procedure|3D power Doppler vaginal ultrasound|To assess the endometrium using the IETA group criteria.
16055099|NCT02488798|Procedure|Office hysteroscopy|using the vaginoscopic approach to assess the uterine cavity and take sample.
16055100|NCT02488785|Behavioral|Virtual Diabetes Self-Care and Education Program|Participants will be able to have frequent contact in order to share physical activity and glucose data with the diabetes educator using the smartphone they will receive. Information downloaded to the Glooko Population Management tool can be shared with the diabetes educator.
16055101|NCT02488785|Device|Fitbit|Participants will be given a Fitbit physical activity tracker which they can use to record their activity and share the information with the diabetes educator using the device's smartphone application.
16055102|NCT02488785|Device|Smartphone|All virtual visits were performed via provided smartphone. In addition, participants will receive a Glooko MeterSync Blue cable which is able to connect to most glucose meters in order to download glucose data to the Glooko Population Management tool on their smartphones
16055103|NCT02488772|Device|Sleep mask|
16055104|NCT02488772|Other|Standard of care|Standard of care as decided by treating emergency physician
16055105|NCT02488772|Device|Ear Plugs|
16055106|NCT02488759|Drug|Nivolumab|
16055107|NCT02488759|Drug|Ipilimumab|
16055108|NCT02488759|Drug|Relatlimab|
16055109|NCT02488759|Drug|Daratumumab|
16055110|NCT02488746|Device|GERDX(TM)|Endoscopic full thickness resection of subepithelial gastric tumors using the GERDX suturing device.
16055111|NCT02488733|Procedure|LSG|In addition to all previously described aspects of conventional medical therapy, patients assigned to surgical treatment will undergo LSG, to be performed in accordance with current international guidelines
16055112|NCT02488733|Drug|CMT|CMT consists in the use of the best treatment strategies, involving pharmacological and dietary therapies, lifestyle and physical activity, with the aim of both glycemic control and weight loss, administered on the basis of the current guidelines of the American Diabetes Association (ADA)[50] and determined on an individual basis [52].The administration of such pharmacological and non-pharmacological therapies will be adjusted in accordance with the algorithms of the ADA .
16055113|NCT02488707|Procedure|laparoscopic intersphincteric resection (LISR group)|the patient undergo laparoscopic mesorectal excision with high inferior mesenteric vein ligation combined with transanal distal resection of the rectum
16055114|NCT02488707|Procedure|Transanal minimally invasive Total mesorectal excision (TAMIS group)|Transanal minimally invasive total mesorectal excision assisted with minilaparoscopy to ligate the inferior mesenteric vessels and splenic flexure mobilization.
16055115|NCT02488694|Drug|Afatinib|40 mg/d
16055116|NCT02488694|Drug|Pemetrexed|500 mg/m² i.v. on d1 of each 21-day cycle
16055117|NCT02488681|Device|Micra Pacemaker Implant|
16055118|NCT02488668|Device|Surface Electrical Stimulation|Surface electrical stimulation using the following devices; 1) INOMED surface stimulator, 2) The EPIONE Psychophysical Testing Platform software for stimulator control. Surface stimulation therapy is provided while providing visual guidance to the subject.
16055120|NCT02488642|Drug|Isosorbide Dinitrate|
16055121|NCT02488642|Drug|Misoprostol|
16055122|NCT02488642|Drug|Oxytocin|Oxytocin was infused in a balanced electrolyte solution beginning with an infusion rate of 2 milli-International Units per minute (mIU/min) and doubling the dose every 15 minutes.
16055123|NCT02488629|Drug|SCB01A|This study is a single arm, open-label, Phase II trial
16055124|NCT02488616|Other|5-day intervention with single-hormone closed-loop strategy|"A sensor will be inserted on the day prior to the first day of the intervention by the participants. On the first day of the intervention, participants will be admitted to the clinical research facility anytime between 8:00 am and 11:30 am. Training on connection and disconnection of the system, meal boluses, etc. will be given.
~Competency on the use of study devices will be assessed by a team member. Only participants demonstrating competency on use of study devices will be allowed to continue to the home study phase. Participants will be advised to continue with study intervention at home for the next 5 days."
16055125|NCT02488616|Other|5-day intervention with sensor-augmented pump therapy|"A sensor will be inserted on the day prior to the first day of the intervention by the participants. The participant will also have to install the study insulin pump. Participants will be advised to continue with study intervention at home for the next 5 days.
~Participants will have been previously shown how to use the study insulin pump."
16055126|NCT02488616|Device|Insulin pump|MiniMed® Paradigm® Veo™, Medtronic
16055127|NCT02488616|Device|Continuous glucose monitoring system|Enlite sensor®, Medtronic
16055128|NCT02488616|Drug|Insulin|Participant's usual fast-acting insulin analog will be used: Lispro (Humalog), Aspart (NovoRapid) or Glulisine (Apidra)
16055129|NCT02488603|Behavioral|Decision aids (tamoxifen-related educational materials in brochure or mobile app)|Decision aids (tamoxifen-related educational materials in brochure or mobile app)
16055130|NCT02488603|Drug|tamoxifen|
16055131|NCT02488590|Drug|LABA + LAMA|An open label inhaled therapy is initiated once the diagnosis has been set based on clinical and testing criteria (algorithm). The treatment may be changed in function of the clinical evolution, which is left at the discretion of the general practitionar. Changes in treatment and treatment doses are registered during 1 year follow-up.
16055132|NCT02488590|Drug|ICS|An open label inhaled therapy is initiated once the diagnosis has been set based on clinical and testing criteria (algorithm). The treatment may be changed in function of the clinical evolution, which is left at the discretion of the general practitionar. Changes in treatment and treatment doses are registered during 1 year follow-up.
16055133|NCT02488590|Drug|LABA + LAMA + ICS|An open label inhaled therapy is initiated once the diagnosis has been set based on clinical and testing criteria (algorithm). The treatment may be changed in function of the clinical evolution, which is left at the discretion of the general practitionar. Changes in treatment and treatment doses are registered during 1 year follow-up.
16055134|NCT02488590|Drug|LABA + ICS|An open label inhaled therapy is initiated once the diagnosis has been set based on clinical and testing criteria (algorithm). The treatment may be changed in function of the clinical evolution, which is left at the discretion of the general practitionar. Changes in treatment and treatment doses are registered during 1 year follow-up.
16055135|NCT02488590|Drug|other|An open label therapy or no therapy is initiated once the diagnosis has been set based on clinical and testing criteria (algorithm). The treatment may be changed in function of the clinical evolution, which is left at the discretion of the general practitionar. Changes in treatment and treatment doses are registered during 1 year follow-up.
16055136|NCT02488577|Procedure|Transanal minimally invasive total mesorectal excision|
16055137|NCT02488577|Procedure|transanal minimally invasive locoregional resection|
16055138|NCT02488564|Drug|Liposomal doxorubicin|50 mg/m2 by intravenous infusion over a period of 1 hour on day 1 of each cycle repeated every 21 days. A final concentration of between 0.4 to 1.2 mg/ml doxorubicin hydrochloride, is required
16055139|NCT02488564|Drug|Docetaxel|30 mg/m2 by intravenous infusion over a period of 1 hour on day 2 and 9, every 3 week.They will be given for 6 cycles.
16055140|NCT02488564|Drug|Trastuzumab|4 mg/kg for the first administration (day 2 cycle 1) and 2 mg/kg for subsequent administrations. Trastuzumab will be given weekly for the duration of chemotherapy (day 2, 9, 16), then will be administered at the dose of 6 mg/Kg every 3 weeks until completion of 52 weeks of treatment.
16055141|NCT02488564|Drug|Metformin|It is administered as single agent from day -13 to 0. From day -13 to day -11, Metformin 1000 mg will be administered once a day; from day -10, Metformin 1000 mg will be administered twice a day continuously until end of the study treatment.
16055142|NCT02488551|Device|Computer-delivered CALM|This intervention includes the delivery of CALM via computer
16055143|NCT02488551|Other|Manual-delivered CALM|This active comparison condition includes the delivery of CALM via manual
16055144|NCT02488538|Drug|Combined oral contraceptives|Women will receive COC containing drospirenone daily for 21 days starting from the 3rd day of menstruation
16055145|NCT02488538|Drug|Fluoxetine|women will receive oral fluoxetine 20 mg daily
16055146|NCT02488538|Drug|Combined oral contraceptives placebo|women will receive oral placebo similar to COC daily for 21 days starting from the 3rd day of menstruation
16055147|NCT02488538|Drug|Fluoxetine placebo|women will receive a daily oral placebo similar in size, color and structure to fluoxetine.
16055148|NCT02488538|Procedure|Daily record of severity of problems|Women will record their symptoms daily using the daily record of severity of symptoms.
16055149|NCT02488525|Drug|Prophylactic treatment with Wilfactin|Prophylactic treatment with Wilfactin after implantation of continuous-flow left ventricular assist device reduces the frequency of bleeding in comparison to the usual care.
16055150|NCT02488512|Drug|90Y-DOTATOC|Each patient will receive a maximum cumulative 90Y-DOTATOC activity of 11.1 GBq (300 mCi) [45-46], divided into 4 cycles (1.8 - 2.8 GBq for each cycle) with an interval of 6 - 8 weeks between cycles. The activity to be administered will be measured in a dose calibrator, properly calibrated for the 90Y-radionuclide.
16055151|NCT02488499|Behavioral|Coping Power|15 sessions of concurrent parent and child group treatment
16055152|NCT02488499|Behavioral|Individualized Treatment|15 sessions of individualized child and parent treatment
16055153|NCT02488486|Device|Automated postoperative sedation|
16055154|NCT02488486|Drug|propofol|
16055155|NCT02488486|Drug|remifentanil|
16055156|NCT02488473|Drug|Dexmedetomidine|100 ug dexmedetomidine added to the ropivacaine nerveblock
16055157|NCT02488473|Drug|Ropivacaine|20 ml Ropivacaine 5mg/ml
16055158|NCT02488473|Drug|Isotonic Saline|Placebo
16055159|NCT02488460|Behavioral|Physically active math lessons|The intervention consists of a nine month period with physical activity as part of, and integrated, in math lessons
16055160|NCT02488434|Device|fertile chip|a new method for sperm selection on ivf cycles by using microchannel system.
16055164|NCT02488395|Other|fMRI|The investigators will use a non invasive fMRI technique centred on the superior colliculus during the presentation of flickered check-boards with varying contrast (1, 3, 5 and 9 %).
16055165|NCT02488395|Other|Ophthalmologic evaluation|The aim of this experiment is the evaluate the functional state of a visual structure. Therefore, with this ophthalmologic test, the investigators will control if the participant does not present major visual deficits. This examination will evaluate the visual acuity and the visual field. A funduscopic examination will also be performed to check the retina.
16055166|NCT02488395|Other|visual psychophysics test|This test will allow to control the sensitivity of the participant to our contrast. The participant will be asked to look at screen on which three static check-boards will be presented. The participant will have to choose the two check-boards with the closest contrast.
16055167|NCT02488382|Drug|Lonquek|Patients will be given a single fixed dose of Lonquek (Teva LTD), 12-mg subcutaneously.
16055168|NCT02488369|Device|PET / CT|
16055169|NCT02488356|Dietary Supplement|Litramine|
16055170|NCT02488343|Behavioral|Behavioral Intervention|Three types of intervention will be used: a) Interventions aimed to dealing with cognitions and habits will be based on cognitive-behavioral therapy (CBT) principles. b) Interventions aimed to dealing with affective factors that interfere with adherence will be based on dynamic therapy, crisis intervention and supportive elements. c) In the case of condition-related or therapy related barriers to adherence, psycho-educational multidisciplinary interventions of 1-2 appointments will be offered. Education about injection techniques and about reasonable expectations from therapy, and from MS itself, are a key strategy to successfully maintaining adherence.
16055276|NCT02487654|Procedure|Ganglionated plexus ablation|Endocardial radiofrequency catheter ablation of ganglionated plexus in the left atrium
16055171|NCT02488330|Drug|Onartuzumab|Onartuzumab 10 mg/kg or 15 mg/kg will be administered intravenously on Day 1 of each 14- or 21-day cycle as specified in the P-trial and as per clinical judgment and discretion of the investigator. The actual dose of onartuzumab will be determined on the bases of participants weight at the time of enrollment in extension trial (E-trial).
16055172|NCT02488330|Drug|Bevacizumab|All participants will continue on the same dose and schedule of control treatment (bevacizumab) as specified in their respective P-trial.
16055173|NCT02488330|Drug|Erlotinib|All participants will continue on the same dose and schedule of control treatment (erlotinib) as specified in their respective P-trial.
16055174|NCT02488317|Other|Decision Aid|Decision-making outcomes (e.g., self-efficacy) will be compared between patients who received and did not receive a decision aid. These arms were chosen because the current standard of care is for health care providers to discuss options with patients without using a decision aid.
16055175|NCT02488304|Radiation|HRCT scans|"A HRCT scan at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) will be taken on visit 2, visit 3, visit 4, visit 5, visit 6, and visit 7.
~An upper airway (UA) scan will be taken on visit 2."
16055176|NCT02488291|Drug|0.25 sufentanil|with different dosage
16055177|NCT02488291|Drug|0.5µg/ml sufentanil|0.5µg/ml sufentanil
16055178|NCT02488291|Drug|0.1% ropivacaine|0.1% ropivacaine
16055179|NCT02488278|Device|GlucoMe Glucose Monitoring Device|Perform a blood glucose test using the application and device
16055180|NCT02488265|Other|Balance Training|Balance training with rhythmical (BRT), is a motor program to improve balance associated with rhythmical auditory cues (RACs).
16055181|NCT02488265|Other|Screening to prevent falls|Questionary to Scheduled screening falls and progression in training will be used to indicate the capacity to continue to progress.
16055182|NCT02488252|Drug|Semi-individualised Chinese Medicine treatment|"A: Panax ginseng, Atractylodes macrocephala, Pinellia ternate, Pericarpium citri reticulatae, Herba Pogostemonis, Glycyrrhiza uralensis, Rehmannia-6 decoction
~B: Cortex magnoliae officinalis, Atractylodes macrocephala, Common Floweringquince Fruit, Common Vladimiria Root, Tsaoko Amomum Fruit, Palmae Fruit, Radixaconiti laterlis perparata, Zingiber officinale Rosc., Glycyrrhiza uralensis, Rehmannia-8 decoction
~C: Root of Pilose Asiabell, Astragalus membranaceus, Rehmannia glutinosa, Common Macrocarpium Fruit, Dioscorea opposita , Barbary Wolfberry Fruit, Cortex eucommiae, Chinese Angelica, Glycyrrhiza uralensis
~D: Rehmannia-6 decoction, Fructus Ligustri Lucidi, Yerbadetajo Herb
~E: Rehmannia-8 decoction, Fructus Ligustri Lucidi, Yerbadetajo Herb"
16055183|NCT02488252|Drug|Routine medical care (active comparator)|Angiotensin converting enzyme inhibitor or angiotensin receptor blocker at stable dose
16055184|NCT02488239|Device|CRT-P indicated patients|Patients who are indicated for a CRT-P device are planned to be implanted with a CRT-P device
16055185|NCT02488226|Other|Gaze-contingent eye-tracking technology|When participants look away from a prototypical or expected norm, their gaze patterns are redirected to those prototypical locations.
16055186|NCT02488213|Other|Nutritional Counseling|The patients with type 2 diabetes mellitus treated in Endocrinology Division, Hospital de Clinicas de Porto Alegre will receive nutritional counseling from the diet quality assessment with adopting some techniques of motivational interviewing, and delivery of educational support material. The patients will need to come to hospital for three more visits every two months throughout the study (2, 4, 6 months). They will also be contacted by telephone during the months when will not have query (1, 3 and 5 months). The study will total duration of six months.
16055187|NCT02488213|Other|Usual Diet Guidance|The patients with type 2 diabetes mellitus treated in Endocrinology Division, Hospital de Clinicas de Porto Alegre will receive usual diet guidance from the current nutritional recommendations for diabetes, according to the routine performed. The patients will need to come to hospital for three more visits every two months throughout the study (2, 4, 6 months). They will also be contacted by telephone during the months when will not have query (1, 3 and 5 months). The study will total duration of six months.
16055188|NCT02488200|Other|No intervention|No intervention
16055189|NCT02488187|Device|ABUS|Automated breast ultrasound
16055190|NCT02488174|Other|PROOFcheck|
16055191|NCT02488174|Other|Standard Care|
16055192|NCT02488161|Other|No intervention|
16055193|NCT02488148|Behavioral|Hot yoga|Subjects in the two intervention groups will complete the standard 26-posture Bikram yoga series in a studio heated at 41ºC (traditional environment) or in a studio at a room temperature of 22ºC whereas control group subjects will be instructed to maintain physical activity patterns for the 12-week study duration. Yoga classes will be held at the Pure Bikram Yoga downtown Austin location. Classes will be completed 3 times weekly for 12 weeks and consist of 90 minutes of yoga postures and breathing exercises.
16055194|NCT02488148|Behavioral|Non-heated yoga|Subjects in the two intervention groups will complete the standard 26-posture Bikram yoga series in a studio heated at 41ºC (traditional environment) or in a studio at a room temperature of 22ºC whereas control group subjects will be instructed to maintain physical activity patterns for the 12-week study duration. Yoga classes will be held at the Pure Bikram Yoga downtown Austin location. Classes will be completed 3 times weekly for 12 weeks and consist of 90 minutes of yoga postures and breathing exercises.
16055195|NCT02488135|Device|Floseal Hemostatic Matrix|Floseal Hemostatic Matrix is a gel like fibrin glue used topically in the nasal cavity and applied with a syringe.
16055196|NCT02488135|Procedure|Traditional Nasal Packing|Using either vaseline gauze or nasal merocels. These will be placed in the anterior nasal cavity using nasal speculum and forceps.
16055197|NCT02488122|Other|High Impact Exercise|In these workouts, both feet leave the ground at the same time.
16055198|NCT02488122|Other|Low Impact Exercise|A workout is low-impact if at least one of your feet remains in contact with the ground at all times.
16055199|NCT02488109|Other|Higher Calorie Refeeding|
16055200|NCT02488109|Other|Lower Calorie Refeeding|
16055201|NCT02488096|Device|TRUS-Guided Biopsy|The standard care TRUS-guided biopsy is a schematic 12 core biopsy scheme with 2 cores taken from each of standard 6 zones. In some cases, the radiologist may take additional cores beyond 12 if suspicious areas are suspected from clinical findings or TRUS. TRUS-guided biopsies will be performed by a designated group of radiologists. An overall score out of 5 of likelihood of clinically significant prostate cancer will be recorded for each individual patient. The biopsy will be scheduled within 1 week of referral.
16055277|NCT02487628|Device|HQ® Matrix Soft Tissue Mesh|
16055202|NCT02488096|Device|MRI + TRUS-Guided Biopsy|"A designated radiologist will perform all MRI exams. The radiologist will identify locations of the prostate gland of the standard 12 cores to be taken and any additional lesions deemed to be suspicious for cancer.
~The procedure for the MRI-targeted biopsy will be exactly the same as the TRUS-guided biopsy except that an additional 2 cores per area may be taken beyond the standard 12 cores in areas that were previously identified by MRI on the map. The systematic 12-core biopsy will always be performed first. The radiologist performing the MRI-targeted biopsy will review the MRI targets prior to the biopsy as per standard of care, and he/she will also perform the TRUS-guided biopsies for this group. Patients will be scheduled for their biopsy ~ 1 week after the MRI."
16055203|NCT02488083|Device|Ultrashape|circumference reduction
16055204|NCT02488070|Procedure|Computed Tomography|Part of PET/CT scan
16055205|NCT02488070|Drug|Gallium Ga 68-labeled PSMA Ligand Glu-urea-Lys(Ahx)|Intravenously-administered (IV) radioisotope
16055206|NCT02488070|Procedure|Magnetic Resonance Imaging|Part of PET/MRI scan
16055207|NCT02488070|Procedure|Positron Emission Tomography|Part of PET/CT and/or PET/MRI scans
16055208|NCT02488057|Drug|Liraglutide|Active comparator. See arm descriptions.
16055209|NCT02488057|Behavioral|Weight loss|Active comparator. See arm descriptions.
16055210|NCT02488044|Drug|AEB1102|modified human arginase I
16055211|NCT02488031|Behavioral|Error-reduction|"During this time participants will use a novel, custom designed computer interface to perform goal-directed movements with each leg in a 3D virtual environment designed to emphasize accurate movements. Leg movement will be detected using the LeapMotion sensor and we will quantify time endpoint errors by comparing the timing of the foot trajectory and the required time to target.
~The error-reduction intervention will be a 4-week home-based program. Each participant will train 4 days a week for approximately 1 hours per day. Within a week, the task difficulty will increase by changing the presentation of the targets to be more unpredictable and by increasing movement speed."
16055212|NCT02488031|Behavioral|International Cooperative Ataxia Rating Scale|The ICARS is an assessment of the ataxia severity. The ICARS score is the total sum of the sub scores on specific movements and ranges from 0 to 100, with a score of 100 being indicative of the most severely affected outcome.
16055213|NCT02488031|Behavioral|Scale for the Assessment and Rating of Ataxia|The SARA is an assessment of the ataxia severity. The SARA score is the total sum of the sub scores on specific movements and ranges from 0 to 100, with a score of 100 being indicative of the most severely affected outcome.
16055214|NCT02488031|Behavioral|Beck Depression Inventory, 2nd Ed|This is a 21 question self-report inventory for measuring severity of depression.
16055215|NCT02488031|Behavioral|Stroop|This test measures selective attention and cognitive flexibility through reading aloud of color names or color of the print.
16055216|NCT02488031|Behavioral|Purdue Pegboard|This test consists of a series of timed hand coordination and dexterity tasks.
16055217|NCT02488031|Behavioral|Brief Test of Attention|A cognitive test assessing focus and attention.
16055218|NCT02488031|Behavioral|6-minute Walk|This test consists on a timed 6-minute walk test to evaluate how much distance is covered.
16055219|NCT02488031|Behavioral|Hand Grip Dynamometer|This tests measures hand grip strength.
16055220|NCT02488031|Behavioral|Montreal Cognitive Assessment|This test is used to assess cognitive abilities.
16055221|NCT02488031|Behavioral|Physical Performance Function|This test consists of a series of physical activities used to evaluate speed, coordination, and ease of movement.
16055222|NCT02488031|Behavioral|Biomechanical Assessments of Dysmetria|Dysmetria will be assessed using a custom-made goal-directed movement protocol where participant perform unloaded limb movement tasks and attempt to reach a space-time target. During these task muscle activity is monitored using Electromyography (EMG) recording.
16055223|NCT02488031|Behavioral|Neurophysiological assessment of brain activity|Neurophysiology will be assessed by monitoring brain activity using Task-based fMRI and motor unit pool activity using a specialized EMG system.
16055224|NCT02488031|Behavioral|Biomechanical gait analysis|Participants will wear APDM's wireless sensors on the hands, legs, trunk and forehead and walk overground a distance of 7 m for 2 minutes. APDM quantifies 80 common biomechanical outcomes of gait (e.g. stride length variability).
16055225|NCT02488018|Biological|Provision of experimental honey|"Acacia, Becium grandiflorum, Croton macrostachys, Eucalyptus globules, Hypoestes, Leaucas abyssinica, Schefflera abyssinica, Syzygium guineense and reference glucose were used as test food.
~25g available carbohydrate of the test food was provided to ten human subjects after fasted for 11 hours overnight."
16055226|NCT02488005|Device|Ultrasound|An ultrasound of the small bowel will be done by a radiologist or ultrasound technician. Subject should not eat or drink anything (i.e. no food and no water/beverages) for 8 hours prior to their ultrasound appointment
16055227|NCT02487992|Biological|Cytokine-Induced Killer Cells|CIK cells transfected with cytokine genes possess an improved proliferation rate and a higher cytotoxic activity as compared to regular CIK cells.
16055228|NCT02487979|Drug|Glembatumumab Vedotin|Given IV
16055229|NCT02487979|Other|Laboratory Biomarker Analysis|Correlative studies
16055230|NCT02487979|Other|Pharmacological Study|Correlative studies
16055231|NCT02487966|Device|transcranial Direct Current Stimulation (tDCS): active (Soterix ©)|Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. For active tDCS, the subject will undergo stimulation for 20 minutes.
16055232|NCT02487966|Behavioral|Mirror Therapy: active|Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist.
16055233|NCT02487966|Device|transcranial Direct Current Stimulation (tDCS): sham (Soterix ©)|Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA on the primary motor cortex contralateral to the amputated leg. The subject will undergo stimulation for 20 minutes. This is the same parameters as the active one, except the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation.
16055234|NCT02487966|Behavioral|Mirror Therapy: Sham|Subjects will be asked to perform movements (15 minutes daily) using the unaffected limb while watching its mirrored reflection superimposed over the affected limb, only the mirror will be covered. During Mirror Therapy, subjects will be asked to consciously relate the movement observed in the mirror to their phantom limb and to keep their attention focused on the task. Instructions will be explained verbally, demonstrated by a therapist, and performed by the subject in front of the therapist. We will use the same all of these techniques as active Mirror Therapy only the mirror will be covered during all activities.
16055235|NCT02487953|Drug|Nicotine patch|21 mg/24 h for 2 weeks before the quit date and 12 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
16055236|NCT02487953|Other|ENDS|As needed for 1 week before the quit date and 8 weeks after the quit date, then reduced use for 4 weeks.
16055237|NCT02487953|Other|Placebo patch|21 mg size for 2 weeks before the quit date and 12 weeks after the quit date, 14 mg size for 2 weeks, and 7 mg size for 2 weeks.
16055238|NCT02487953|Other|Placebo ENDS|As needed for 1 week before the quit date and 8 weeks after the quit date, then reduced use for 4 weeks.
16055239|NCT02487940|Drug|Intralipid 20%|Women with RIF received intralipid 20% (at a dose of 9mg/mL of the total blood volume, corresponding to 2 mL intralipid diluted at 20% in 250 mL normal saline) given over 1-2 hours on the day of oocyte retrieval. Dose is repeated on/the following day of a positive pregnancy test, followed by a final dose 2-3 weeks later when attending for pregnancy scan.
16055240|NCT02487940|Drug|Normal saline|Women with RIF received intravenous infusion of 250 mL physiological saline solution over 1-2 hours on the day of oocyte retrieval. Dose is repeated on/the following day of a positive pregnancy test, followed by a final dose 2-3 weeks later when attending for pregnancy scan.
16055241|NCT02487927|Behavioral|weaning|T piece
16055242|NCT02487914|Device|iontophoresis of Lidocaine 10% with interferential current (Dynatron 438)|drug delivery through interferential current.
16055243|NCT02487914|Drug|Lidocaine 10% was sprayed at the identified region|
16055244|NCT02487914|Device|interferential current|
16055245|NCT02487901|Device|ultrasonic osteotome|making gutter with ultrasonic osteotome
16055246|NCT02487901|Device|drill|making gutter with drill
16055247|NCT02487888|Other|Unblinded to Genetic Testing Results|The physicians of this group of patients will be unblinded to the results of the genetic testing.
16055248|NCT02487888|Other|Blinded to Genetic Testing Results|The physicians of this group of patients will be blinded to the results of the genetic testing. They will be un-blinded to the results of each patient once that patient has completed the study.
16055249|NCT02487875|Other|rehabilitation|
16055250|NCT02487862|Behavioral|Stress Reduction Protocol|Stress Reduction Protocol
16055251|NCT02487849|Procedure|HIPEC|secondary cytoreductive operation
16055252|NCT02487849|Drug|Carboplatin|Hyperthermal Intraperitoneal Chemotherapy (HIPEC)
16055253|NCT02487836|Device|Type WallFlex or Evolution biliary, stent system|Laying of a stent biliary
16055254|NCT02487823|Drug|BKM120 in combination with LH-RH agonists (suprefact) and bicalutamide|BKM 120, LH-RH agonists and Bicalutamide
16055255|NCT02487810|Behavioral|Cognitive load|Patients in the intuition arm of the study will be asked to complete a memorization task while they are answering survey questions.
16055256|NCT02487810|Behavioral|Deliberative instructions|Patients in the deliberative arm will be given instructions to take their time and deliberate on their decisions
16055257|NCT02487797|Drug|Oxytocin|
16055258|NCT02487797|Other|Sodium Chloride 0.9%|
16055259|NCT02487784|Procedure|Block allograft|A cancellous block allograft plus corticocancellous particulate allograft will be used as the positive control treatment.
16055260|NCT02487784|Procedure|Particulate allograft + autogenous bone chips|The test arm of this study will include a mix of particulate bone allograft and autogenous bone chips.
16055261|NCT02487771|Drug|DHA|600 mg DHA capsule
16055262|NCT02487771|Drug|Placebo Capsule|600 mg of Soybean Oil and Corn Oil, which does not contain any DHA
16055263|NCT02487758|Procedure|Ridge Preservation|Ridge Preservation Comparing the Clinical and Histologic Healing of Flap vs. Flapless Approach to Grafting
16055264|NCT02487745|Behavioral|Abstinence-contingent wage supplements|Before obtaining competitive employment, participants will be able to earn wage supplements for attending two individual placement and support (IPS) supported employment sessions per week, and for completing specific tasks prescribed by IPS including developing a worker profile, applying for appropriate jobs, and completing job interviews. Once a participant becomes employed, participants will be able to earn up to $5 per hour for every hour worked in a competitive job up to 40 hours per week verified by pay stubs. To maintain long-term drug abstinence, participants will be required to provide urine samples to earn the maximum in wage supplements.
16055265|NCT02487745|Behavioral|Individual Placement and Support (IPS) supported employment|Individual Placement and Support (IPS) supported employment involves rapid job search, promotes competitive employment, considers the participant's preferences, and provides job supports and benefits counseling. An employment specialist will establish relationships will potential employers and work with participants to identify potential jobs, prepare applications, and to apply for positions.
16055266|NCT02487732|Drug|Ticagrelor|Ticagrelor 90mg twice daily for 5 weeks
16055267|NCT02487732|Drug|Prasugrel|Prasugrel 10mg once daily for 5 weeks
16055268|NCT02487719|Drug|Iron sulfate and Iron polymaltose for prevention of iron deficiency anemia|
16055269|NCT02487706|Drug|Dolutegravir|Dolutegravir 50mg/day per 5 days
16055270|NCT02487693|Procedure|Radiofrequency ablation|Radiofrequency ablation is performed percutaneously under CT/US guidance
16055271|NCT02487693|Biological|Cytokine-induced killer cells|The patients received autologous cytokine-induced killer cells transfusion one week after RFA treatment.
16055272|NCT02487680|Dietary Supplement|Amino Acids and chromium-picolinate containing drink|Evaluation of the dietary supplement drink containing amino acids and chromium picolinate and aroma
16055273|NCT02487680|Dietary Supplement|Placebo drink|Evaluation of the placebo supplement drink containing only aroma
16055274|NCT02487667|Device|Therapeutic exercise by fitness machines|Therapeutic exercise program by using 8 exercise machine circuit
16055275|NCT02487654|Procedure|Pulmonary vein isolation|Conventional endocardial radiofrequency catheter ablation for pulmonary vein isolation.
16055281|NCT02487589|Other|Telephone support, telemonitoring and tele-exercise|"The care model will provide 24/24 h assistance for six months and include:
~Telephone Support: a nurse-tutor (NT) will follow-up the enrolled patients weekly mainly through scheduled appointments. NTs duties will be: 1 education (patients and family ' s health education on how to prevent falls, verification of the adherence to the pharmacological therapy, teaching on how to recognize problems that can conduct to falls) and 2. management. Occasional appointments will be required by patients on duty and managed by a nurse .
~Telemonitoring: all patients will send proper biological traces and data will be registered on a personal health record.
~Tele-exercise: Home exercises sessions will be provided by a DVD and monitored through a videoconference by a physiotherapist."
16055282|NCT02487576|Other|Carbohydrate-rich (HC)|65% Carbohydrate; 20% Fat; 15% Protein
16055283|NCT02487576|Other|Fat-rich (HF)|35% Carbohydrate; 50% Fat; 15% Protein
16055284|NCT02487563|Drug|Decitabine|Decitabine
16055285|NCT02487563|Drug|rhTPO|rhTPO
16055286|NCT02487563|Other|Conventional Treatment|immunoglobulin, glucocorticoid etc
16055287|NCT02487550|Biological|DC-CIK|Patients with renal cell carcinoma will receive autologous dendritic cells loaded with autologous tumor lysate (dendritic cell vaccine) by venous infusion of CIK cells.
16055288|NCT02487550|Biological|IL-2/IFN-α|Patients with renal cell carcinoma will receive IL-2/IFN-α by venous infusion.
16055289|NCT02487537|Dietary Supplement|custom-made soft drink|
16055290|NCT02487524|Other|Cold water test|The patients immerse their hand into cold water for a maximum of 90 seconds and report their pain intensity every 15 seconds during the test.
16055291|NCT02487524|Other|Autonomic nervous system monitoring|The autonomic nervous system is monitored during the cold water test and 15 minutes thereafter.
16055292|NCT02487524|Other|QST|Quantitative sensory testing.
16055293|NCT02487511|Other|Duration of HP therapy|the comparison of HP eradication rate between 7 days and 14 days
16055294|NCT02487498|Drug|QVA149|QVA149 capsules for inhalation, delivered via QVA149 SDDPI
16055295|NCT02487498|Drug|Umeclidinium/vilanterol|Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler
16055296|NCT02487498|Drug|Placebo (umeclidinium/vilanterol )|Matching Placebo to umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler
16055297|NCT02487498|Drug|Placebo (QVA149)|Matching Placebo to QVA149 capsules for inhalation, delivered via QVA149 SDDPI
16055298|NCT02487485|Drug|Ketamine|. Subjects will receive an infusion of ketamine (0.5 mg/kg infusion over approximately 40 minutes). All subjects will receive two ketamine infusions-once with a placebo and once with a single dose of sirolimus (6 mg, oral administration).
16055299|NCT02487485|Drug|sirolimus|Subjects will receive a single 6 mg oral dose via oral solution of sirolimus or a dose of placebo approximately two hours prior to the infusions. As above, the order of placebo and sirolimus is randomized. The sirolimus dose as well as the placebo solution will be given in 6 ounces of orange juice.
16055300|NCT02487485|Drug|Placebo|Placebo oral dose
16055301|NCT02487472|Other|Data collection|Data sheet, ZBPI questionnaire and EQ-5D 5L Health state questionnaire
16055302|NCT02487459|Biological|BPX-501|T cells transduced with CaspaCIDe suicide gene
16055303|NCT02487459|Drug|AP1903|dimerizer drug administered to treat GVHD
16055304|NCT02487446|Drug|QVA149|QVA149 capsules for inhalation, delivered via QVA149 single dose dry powder inhaler (SDDPI)
16055305|NCT02487446|Drug|Umeclidinium/vilanterol|Umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler
16055306|NCT02487446|Drug|Placebo (umeclidinium/vilanterol)|Matching Placebo to umeclidinium/vilanterol for inhalation, delivered via ELLIPTA® inhaler
16055307|NCT02487446|Drug|Placebo (QVA149)|Matching Placebo to QVA149 capsules for inhalation, delivered via QVA149 SDDPI
16055308|NCT02487433|Drug|Tofacitinib MR 22 mg (Fed)|A single dose of tofacitinib modified release 22 mg tablet after receiving the standard FDA high-fat/high-calorie meal
16055309|NCT02487433|Drug|Tofacitinib MR 22 mg (Fasted)|A single dose of tofacitinib modified release 22 mg tablet after an overnight fast of 10 hours
16055310|NCT02487420|Behavioral|shorter or longer period of specific dietary restrictions|step by step gradual introduction of egg containing food products
16055311|NCT02487407|Drug|ODM-109|ODM-109 1 mg capsule for oral administration.
16055312|NCT02487407|Drug|Placebo for ODM-109|Placebo capsule for oral administration.
16055313|NCT02487394|Other|Asthma, Smokers and Non-Smokers|Comparing protein expressions between the two groups.
16055314|NCT02487394|Other|COPD, Smokers and Non-Smokers|We will validate the prdictive value of the proteomic signatures for therapeutic responses.
16055315|NCT02487381|Drug|delta-9-tetrahydrocannabinol|
16055316|NCT02487381|Drug|Cannabidiol|
16055317|NCT02487381|Drug|Placebo|
16055318|NCT02487368|Device|Needle stimulation pad|
16055319|NCT02487355|Drug|Dexmedetomidine|Dexmedetomidine 1 μg/ kg
16055320|NCT02487355|Drug|Magnesium Sulphate|Magnesium Sulphate 50 mg
16055321|NCT02487355|Drug|Bupivacaine|1ml/kg of 0.25%of bupivacaine
16055322|NCT02487355|Drug|Dexmedetomidine + Magnesium Sulphate + Bupivacaine|Dexmedetomidine 1 μg/ kg + Magnesium Sulphate 50 mg + 1ml/kg of 0.25%of bupivacaine
16055323|NCT02487342|Other|milk|small serving (217 mL) of british semi-skimmed milk
16055324|NCT02487342|Other|orange fruit-juice|small serving (217 mL) of orange juice
16055325|NCT02487329|Other|Calcium Hydroxide|Exposed area was sealed with a self-hardening calcium hydroxide paste then final restoration was completed using a resin-modified glass ionomer and a nanohybrid composite resin
16055326|NCT02487329|Other|Er,Cr:YSGG laser + calcium hydroxide|After the exposed area was irradiated with Er,Cr:YSGG laser at an energy level of 0,5 W, a repetition rate of 20 Hz, 140 µs pulse duration with 0% water and 45% air for 10 s, it was sealed with a self-hardening calcium hydroxide paste.Then final restoration was completed using a resin-modified glass ionomer and a nanohybrid composite resin
16055327|NCT02487329|Other|TheraCal LC|TheraCal LC was applied directly to the exposed pulp with a needle tip syringe in incremental layers that was not to exceed 1 mm in depth. Then final restoration was completed using a resin-modified glass ionomer and a nanohybrid composite resin
16055357|NCT02487160|Device|SBL-3 multifocal intraocular lens|The SBL-3 intraocular lens will be implanted after the cataractous natural lens has been removed, in those patients randomized into this group
16055328|NCT02487329|Other|Er,Cr:YSGG laser + TheraCal LC|After the exposed area was irradiated with Er,Cr:YSGG laser at an energy level of 0,5 W, a repetition rate of 20 Hz, 140 µs pulse duration with 0% water and 45% air for 10 s, TheraCal LC was used to seal the treated area. Then final restoration was completed using a resin-modified glass ionomer and a nanohybrid composite resin
16055329|NCT02487316|Drug|crizotinib|crizotinib 250mg, oral, bid from day 1 to 18 weeks. cyclophosphamide, 750mg/m2,d1, vincristine, 1.4mg/m2, maximal dose is 2mg d1, doxorubicin, 50mg/m2d1, prednison, 100 mg d1-5) every 3 weeks for up to six cycles.
16055330|NCT02487303|Drug|Acetaminophen Intravenous|IV 1 gram f3 doses over 24 hours
16055331|NCT02487303|Drug|Acetaminophen Oral|Oral 1 gram 3 doses over 24 hours
16055332|NCT02487290|Device|Aneufix ACP-T5|The ACP-T5 is injected via translumbar approach into the aneurysm sac near the entrance/exit of bloodvessel. ACP-T5 will cure and block the endoleak.
16055333|NCT02487277|Drug|PEGPH20|
16055334|NCT02487277|Drug|Gemcitabine|
16055335|NCT02487277|Drug|Nab-paclitaxel|
16055336|NCT02487251|Behavioral|Meal Delivery|Participants receive a healthy, prepared family meal for consumption at home. Meals are received one per week for 8 weeks in Phase 1 of the study. In Phase 2 of the study, meal delivery reflects two meals per week for 12 weeks in Phase 1 of the study. Meal delivery plus cookware delivery is tested in Phase 2 in a randomized controlled trial.
16055337|NCT02487251|Behavioral|Ingredient Delivery|Participants receive ingredients to prepare a healthy, family meal for consumption at home. Meal ingredients are received one per week for 8 weeks. Recipes for the meals are provided. This component was included only in Phase 1 of the study and not in Phase 2 of the study.
16055338|NCT02487251|Behavioral|Community Kitchen|Participants come to a Head Start site to prepare a family entree to take home, cook, and consume. Participants prepare their meals in small groups with an MSU Extension paraprofessional as a facilitator. The Community Kitchen is held once per week for 8 weeks in Phase 1 of the study. This component was included only in Phase 1 of the study and not in Phase 2 of the study.
16055339|NCT02487251|Behavioral|Healthy Eating Classes|Participants attend a small-group class on healthy eating, nutrition and meal planning ideas. Recipes are provided. Classes are held once per week for 8 weeks Phase 1 of the study. This component was included only in Phase 1 of the study and not in Phase 2 of the study.
16055340|NCT02487251|Behavioral|Cooking Demonstrations|Participants meet in small groups and observe as an MSU paraprofessional demonstrates the preparation of a healthy family entree. Participants taste the recipe but do not take food home with them. Recipes are provided. Demonstrations are held once per week for 8 weeks Phase 1 of the study. This component was included only in Phase 1 of the study and not in Phase 2 of the study.
16055341|NCT02487251|Behavioral|Provision of Cookware|Participants receive a set of basic cookware and dishes to use in preparing healthy family meals at home. Recipes are provided. The cookware set is provided at the beginning of the typical 8 week intervention cycle in Phase 1 of the study. Meal delivery plus cookware delivery is tested in Phase 2 in a randomized controlled trial.
16055342|NCT02487251|Behavioral|Usual Exposure|Participants receive no supplemental information on family mealtimes beyond what is already currently received
16055343|NCT02487238|Biological|Fecal Microbiota Enema|Active intervention.
16055344|NCT02487238|Biological|Normal Saline Enema|Placebo comparator.
16055345|NCT02487225|Drug|Pentoxifylline|Pentoxifylline is a competitive nonselective phosphodiesterase inhibitor which raises intracellular cyclic adenosine monophosphate (cAMP), activates protein kinase A (PKA), inhibits Tumor Necrosis Factor (TNF) and leukotriene synthesis, and reduces inflammation and innate immunity. In addition, pentoxifylline improves red blood cell deformability (known as a haemorrheologic effect), reduces blood viscosity and decreases the potential for platelet aggregation and thrombus formation.Pentoxifylline is also an antagonist at adenosine 2 receptors
16055346|NCT02487225|Drug|Placebo|A harmless pill that has no therapeutic effect, used as a control in testing of investigational drug
16055347|NCT02487212|Drug|0.05% Clobetasol propionate|0.05% Clobetasol propionate was rubbed for 2 minutes on one side of the scar immediately after treated with fractional Erbium: YAG (2,940-nm) laser. The treatment was done in every 2 weeks for 4 sessions
16055348|NCT02487212|Drug|Petrolatum gel|Petrolatum gel was rubbed for 2 minutes on the other side of the scar immediately after treated with fractional Erbium: YAG (2,940-nm) laser.The treatment was done in every 2 weeks for 4 sessions
16055349|NCT02487212|Device|Fractional Erbium:Yag (2,940-nm) laser|The parameter of the laser was 28 J/cm2, 5% spot density, 1 pass for the whole scar. The treatment was done in every 2 weeks for 4 sessions
16055350|NCT02487199|Drug|ombitasvir/paritaprevir/ritonavir and dasabuvir|Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet
16055351|NCT02487199|Drug|ombitasvir/paritaprevir/ritonavir|Tablet; ombitasvir coformulated with paritaprevir and ritonavir
16055352|NCT02487186|Drug|Doxicicline|Association of doxycycline (DOX) encapsulated in PLGA microspheres to ultrasonic debridment for the treatment of patients with chronic generalized periodontitis.
16055353|NCT02487186|Procedure|Full-mouth debridment|"The patients will be treated by a single-session of periodontal debridement
~during 45 minutes, using an ultrasonic instrument (Cavitron, Dentsply, Rio de
~Janeiro, Brazil), under irrigation with sterile saline solution 20. After the debridement, local administration of microspheres loading doxycycline (DOX) (test) or empty microspheres (control) was performed."
16055354|NCT02487173|Device|Respirio Flu Test|The Respirio Flu Test is a rapid test for the detection of influenza A or influenza B in nasal secretions. The Respirio Flu Test is designed to be simple to use and generates a result within 20 minutes.
16055355|NCT02487173|Device|Reverse Transcriptase Polymerase Chain Reaction (RT-PCR)|Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) is a molecular diagnostic technique for the detection and identification of influenza viruses, both for clinical samples and isolates. The reverse-transcriptase polymerase chain reaction (RT-PCR) allows template viral RNA to be reverse transcribed producing complementary DNA (cDNA) which can then be amplified and detected.
16055356|NCT02487173|Device|Sofia® Influenza A+B Fluorescent Immunoassay (FIA)|Sofia® Influenza A+B Fluorescent Immunoassay (FIA) employs immunofluorescence to detect influenza A and influenza B viral nucleoprotein antigens in nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash samples taken directly from symptomatic patients.
16055534|NCT02485951|Procedure|Peripheral air injection|Air was injected at the corneal periphery outside the trephination site.
16055358|NCT02487160|Device|Control monofocal intraocular lens|The Control intraocular lens will be implanted after the cataractous natural lens has been removed, in those patients randomized into this group
16055359|NCT02487147|Other|Free Air Portable Air Powered Respirator|The Free Air PAPR is a portable air powered respirator that you will wear like a backpack with a mask and tubing attached.
16055360|NCT02487147|Other|N95 Respirator|The N95 respirator is a mask that is standardly used clinically at Wake Forest Baptist Health.
16055361|NCT02487134|Device|TIGR Matrix|Reinforcement of the suture line with resorbable mesh
16055362|NCT02487134|Device|Control|Closure of the abdomen with conventional technique
16055363|NCT02487121|Behavioral|variable interval schedule|12 group-based extended care treatment sessions scheduled in 3, 4-week periods over a 12-month period
16055364|NCT02487121|Behavioral|self-directed treatment|provision of treatment materials with instruction to work through materials at participant's own pace
16055365|NCT02487108|Drug|Hydrocodone bitartrate|5.0 mg, 7.5 mg, 10 mg
16055366|NCT02487108|Drug|Acetaminophen|325 mg
16055367|NCT02487108|Drug|Placebo|Matching Placebo
16055368|NCT02487095|Drug|Topotecan|Topotecan (incombination with M6620) administered by IV Days 1-5 in a 21 day cycle, until disease progression or development of intolerable side effects.
16055369|NCT02487095|Drug|VX-970 (M6620)|M6620 (in combination with Topotecan) administered by IV Day 5 or Days 2 and 5 in a 21 day cycle, until disease progression or development of intolerable side effects.
16055370|NCT02487082|Drug|Melatonin and Donepezil|The duration depends on group assignment.
16055371|NCT02487082|Other|Placebo|The duration depends on group assignment.
16055372|NCT02487069|Procedure|HSCT from MSD|HSCT from MSD is the first choice for the patients who have HLA-matched sibling donors.
16055373|NCT02487069|Procedure|HSCT from MUD|HSCT from MUD is the second choice for the patients who don't have HLA-matched sibling donors but have HLA-matched unrelated donors.
16055374|NCT02487069|Procedure|HSCT from HRD|HSCT from HRD is the choice for the patients who have neither HLA-matched sibling donors nor HLA-matched unrelated donors.
16055375|NCT02487069|Drug|Cyclosporin A|CsA is used in all the patients for GVHD prophylaxis.
16055376|NCT02487069|Drug|Methotrexate|MTX is used in all the patients for GVHD prophylaxis.
16055377|NCT02487069|Drug|Antithymocyte globulin|ATG is used in the patients receiving HSCT from MUD and HRD for GVHD prophylaxis.In MUD group,total ATG doses is 7 mg/kg;In HRD group,total ATG doses is 7.5 or 10 mg/kg.
16055378|NCT02487069|Drug|Mycophenolate mofetil|MMF is used in the patients receiving HSCT from MSD and HRD for GVHD prophylaxis.
16055379|NCT02487043|Behavioral|A telephone-based case-management intervention|Regular Telephone support delivered by Health coaches
16055380|NCT02487030|Drug|LDV/SOF|90/400 mg FDC tablet administered orally once daily
16055381|NCT02487030|Drug|RBV|Tablets administered orally in a divided daily dose based on weight (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16055382|NCT02487017|Procedure|Transcatheter Arterial Chemoembolization (TACE)|"Transcatheter Arterial Chemoembolization (TACE):
~5-FU 400mg/m2 Hepatic arterial infusion ,lipiodol amount is usually 20 ml,the perfusion time should not be less than 20 min"
16055383|NCT02487017|Biological|DC-CIK|"Transcatheter Arterial Chemoembolization (TACE):
~5-FU 400mg/m2 Hepatic arterial infusion ,lipiodol amount is usually 20 ml, the perfusion time should not be less than 20 min
~DC-CIK:
~8×10^9 DC-CIK cells for each infusion, IV (in the vein) for each infusion at least 3 cycles, each cycle received four infusions on day 14, 16, 30 and 32"
16055384|NCT02487004|Device|hemodialysis|
16055385|NCT02486991|Procedure|Tunnel + AlloDerm®|A coronally positioned tunnel (CPT) technique for root coverage will be used alone with acellular dermal matrix (AlloDerm®).
16055386|NCT02486991|Procedure|Tunnel + AlloDerm® + Verticals|The use of intramucosal vertical incisions in addition to a coronally positioned tunnel (CPT) technique for root coverage will be used with acellular dermal matrix (AlloDerm®).
16055387|NCT02486978|Other|Control (109 g white bread)|Control meal of 109 g white bread to which the response of the test meals with dietary supplements will be compared to.
16055388|NCT02486978|Dietary Supplement|Dose 1|The test meal will contain a single dose of the supplements whose response will be compared to that of the control meal.
16055389|NCT02486978|Dietary Supplement|Dose 2|The test meal will contain a double dose of the supplements whose response will be compared to that of the control meal.
16055390|NCT02486965|Device|thermode (TSA-II model)|thermal stimulation with test thermode
16055391|NCT02486965|Other|Adapted Physical Activity|
16055392|NCT02486965|Other|Physical activity|
16055393|NCT02486952|Drug|Cyclophosphamide|Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.
16055394|NCT02486952|Drug|Hydroxydaunorubicin|Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.
16055395|NCT02486952|Drug|Oncovin|Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.
16055396|NCT02486952|Drug|Prednisone|Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.
16055397|NCT02486952|Drug|Rituximab|Administered at the treating physician's discretion and according to package labeling, within approved indication and local approval status of the drug.
16055398|NCT02486939|Drug|CHS-0214|Open label
16055399|NCT02486926|Other|Sevoflurane|Anesthesia of patients was maintained only with sevoflurane.
16055400|NCT02486926|Drug|Remifentanil|Anesthesia of patients was maintained with both sevoflurane and continuous remifentanil infusion.
16055401|NCT02486926|Drug|Alfentanil|Anesthesia was maintained with both sevoflurane and continuous infusion of remifentanil. Alfentanil was administrated (5ug/kg) to patients 10 minutes before the end of surgery.
16055402|NCT02486926|Drug|Thiopental|General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients.
16055403|NCT02486926|Drug|Rocuronium|General anesthesia was induced with thiopental 5 mg/kg, rocuronium 0.6 mg/kg and sevoflurane in all patients.
16055404|NCT02486913|Other|Enhanced Health Check|National Health Service Health Check enhanced by risk report
16055405|NCT02486900|Device|fMRI-based neurofeedback|During scanning patients will be exposed to picture stimuli (showing alcoholic drinks and life goals) projected on a screen behind the scanner and viewed through a mirror attached on the MRI head coil. In each session patients will be trained to down-regulate/up-regulate activation levels in brain areas that show reliable responses to the alcohol/life goals pictures in a 'localiser' scan. Self-regulation of these brain responses will then be guided by real-time feedback of alcohol/life goals-cue elicited activation, consisting of changes in the visible alcohol/life goals picture (decreasing size = successful down-regulation; increasing size = successful upregulation). Functional MRI data will be acquired in short blocks having a duration of 5-8 minutes.
16055406|NCT02486887|Device|telemonitoring of weight, pulse and blood pressure|
16055407|NCT02486874|Device|PoreSkin|a human acellular dermal matrix
16055408|NCT02486861|Other|optical coherence tomography|
16055409|NCT02486848|Drug|5% Topical Minoxidil Solution|5% Topical Minoxidil Solution
16055410|NCT02486848|Drug|15% Topical Minoxidil Solution|15% Topical Minoxidil Solution
16055411|NCT02486835|Device|Cough syrup for adults and children|Dosage is 5 ml three times a day for 4 nights, 3 days
16055412|NCT02486835|Device|Placebo|Dosage is 5 ml three times a day for 4 nights, 3 days
16055413|NCT02486822|Procedure|Amniotomy|Amniotomy, artificial rupture of membranes, is done with initial delay of labor (in partograph: extension beyond alert line, in labor scale: when progress reaches the membrane line)
16055414|NCT02486822|Drug|Oxytocin|Oxytocin augmentation: given with further delay of labour (according to the point of intervention of the partograph or the scale)
16055415|NCT02486822|Procedure|Cesarean Section|Cesarean section: done when progress is deemed arrested (according to the definition of the partograph or the scale)
16055416|NCT02486809|Drug|Lebrikizumab|Participants will receive a single SC dose of lebrikizumab, delivered via needle and syringe or PFS-NSD.
16055417|NCT02486796|Biological|Reishi mushroom extract|Reishi mushroom preparation produced water-ethanol extraction.
16055418|NCT02486796|Drug|Coenzyme Q10|Preparation of coenzyme Q10
16055419|NCT02486796|Drug|Melatonin|Preparation of melatonin
16055420|NCT02486770|Biological|Aerucin 2.0mg/kg|IV Aerucin 2.0 mg/kg over 1 hour
16055421|NCT02486770|Biological|Aerucin 8.0mg/kg|IV Aerucin 8.0 mg/kg over 1 hour
16055422|NCT02486770|Biological|Aerucin 20.0 mg/kg|IV Aerucin 20 mg/kg over 1 hour
16055423|NCT02486757|Drug|micronized progesterone|
16055424|NCT02486757|Drug|transdermal estradiol|
16055425|NCT02486744|Drug|Acthar Gel|Subjects will be given an injection subcutaneously 2x week for 6 months. Dosing will be randomly assigned as either 80 U or 40 U
16055426|NCT02486718|Drug|Atezolizumab|Participants will receive atezolizumab (1200 mg IV) Q3W for 16 cycles (cycle length=21 days).
16055427|NCT02486718|Drug|Cisplatin|Participants will receive cisplatin 75 milligrams per square meter (mg/m^2) IV on Day 1 of up to four 21-day cycles.
16055428|NCT02486718|Drug|Vinorelbine|Participants will receive vinorelbine 30 mg/m^2 IV on Days 1 and 8 of each of the four 21-day cycles.
16055429|NCT02486718|Drug|Docetaxel|Participants will receive docetaxel 75 mg/m^2 IV on Day 1 of each of the four 21-day cycles.
16055430|NCT02486718|Drug|Gemcitabine|Participants will receive gemcitabine 1250 mg/m^2 IV on Days 1 and 8 of each of the four 21-day cycles.
16055431|NCT02486718|Drug|Pemetrexed|Participants will receive pemetrexed 500 mg/m^2 IV on Day 1 of each of the four 21-day cycles. Pemetrexed will be administered only in participants with non-squamous cell NSCLC.
16055432|NCT02486705|Behavioral|PTSD Family Coach Full|PTSD Family Coach mobile app is an iOS mobile phone application designed to provide information, support resources, tools for coping with caregiver-related stress, and tools for self-monitoring stress symptoms.
16055433|NCT02486705|Behavioral|PTSD Family Coach Basic|PTSD Family Coach mobile app is an iOS mobile phone application designed to provide information and support resources,
16055434|NCT02486692|Other|AboutFace Website|AboutFace is an informational website that utilizes digital storytelling to describe PTSD symptoms and different treatments for PTSD.
16055435|NCT02486679|Drug|Prostin (PGE2) tablets|
16055436|NCT02486679|Device|Foley catheter|
16055437|NCT02486666|Drug|Enoxaparin|WEIGHT ADJUSTED FiXED DOSE OF LOW MOLECULAR WEIGHT HEPARIN (ENOXAPARIN) TO NEONATES AND CHILDREN WITH THROMBOSIS (FiXET)
16055438|NCT02486653|Drug|Tamsulosin|"Tamsulosin 0.4mg capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.
~Outline of schedule:
~Day 1-7: tamsulosin 0.4mg in the evening
~Day 8: surgery; tamsulosin 0.4mg in the evening if the subject has not yet completed the bladder management protocol
~Day 9-14: tamsulosin 0.4mg in the evening until the subject either 1) completes the bladder management protocol (defined by two consecutive voids with post-void residual <200mL), or 2) has an indwelling urinary catheter replaced, or 3) is discharged from the hospital, whichever occurs first. The minimum number of total doses is 7; the maximum number of total doses is 14. The 14th dose will be the final dose regardless of bladder function."
16055439|NCT02486653|Drug|Placebo|"Placebo capsule orally once daily, dosed 30 minutes after dinner or before bed, starting 7 days before surgery and continuing for 0-5 days postoperatively.
~Outline of schedule:
~Day 1-7: placebo in the evening
~Day 8: surgery; placebo in the evening if the subject has not yet completed the bladder management protocol
~Day 9-14: placebo in the evening until the subject either 1) completes the bladder management protocol (defined by two consecutive voids with post-void residual <200mL), or 2) has an indwelling urinary catheter replaced, or 3) is discharged from the hospital, whichever occurs first. The minimum number of total doses is 7; the maximum number of total doses is 14. The 14th dose will be the final dose regardless of bladder function."
16055440|NCT02486640|Drug|Interferon beta-1b (Betaferon, BAY86-5046)|Multiple Sclerosis patients who are treated with Betaferon and who are using the Betaconnect autoinjector.
16055441|NCT02486640|Device|Betaconnect Autoinjector|Multiple Sclerosis patients who are treated with Betaferon and who are using the Betaconnect autoinjector.
16055442|NCT02486627|Drug|plazomicin|
16055443|NCT02486627|Drug|meropenem|
16055444|NCT02486627|Drug|levofloxacin (oral)|
16055445|NCT02486614|Procedure|CRRT|citrate based continuous renal replacement therapy
16055446|NCT02486601|Drug|nab-paclitaxel|nab-paclitaxel : 150 mg/m2 D1 every 2 weeks
16056070|NCT02482129|Drug|Dexamethasone 0.1% ophthalmic solution|
16055447|NCT02486601|Drug|FOLFOX|Leucovorin: 400 mg/m2 D1 every 2 weeks Oxaliplatin: 85 mg/m2 D1 every 2 weeks Fluorouracil (5-FU) infusion: 2400mg/m2 48h infusion every 2 weeks
16055448|NCT02486588|Other|Messaging|See detailed study description for overview of the different messaging interventions in this study
16055449|NCT02486588|Other|Financial incentives|See detailed study description for overview of the different financial incentive-based interventions in this study
16055450|NCT02486575|Other|Self-learning|Every resident will train following the video instruction included in the FLS course material and related written instruction only
16055451|NCT02486575|Other|Mentoring|A tutor will follow each resident during learning, giving instruction, examples and any kind of suggestions.
16055452|NCT02486549|Procedure|Supraclavicular Block|Under ultrasound guidance an insulated needle is advanced with in- plane technique into the brachial plexus sheath and 20ml 0.25% bupivacaine will be administered
16055453|NCT02486549|Procedure|Interscalene Block|Under ultrasound guidance an insulated needle will be placed through the middle scalene muscle,into the interscalene groove with in-plane technique and 20ml 0.25%bupivacaine will be administered into the brachial plexus
16055454|NCT02486549|Drug|Bupivacaine|20ml 0.25% bupivacaine will be injected for brachial plexus block
16055455|NCT02486549|Device|Ultrasound|The Ultrasound will be used for brachial plexus visualization
16055456|NCT02486536|Drug|polyethylene glycol|
16055457|NCT02486536|Device|capsule endoscopy|
16055458|NCT02486523|Behavioral|Hygiene promotion sessions|Hygiene promotion sessions are provided weekly to the caretakers at the health center level. They contain 7 main messages this study is trying to get across: Allocate a protected space for children to play, limiting the likelihood of them ingesting soil or animal feces; Wash the child with soap (hand, face) when outside the protected area; Cleaning and rapid burial of children's stools; Key times for hand washing with soap for the child caretaker; Store drinking water in a closed container located in an elevated place out of reach of animals; Drinking water provided to the child should be treated with chlorine or boiled; Once weaned, avoid giving to the child leftover food, or only after warming it again.
16055459|NCT02486523|Device|Household WASH package|The content of the kit: 200 g soap, aquatab 67 g, 20 liters Jerry can, a cup, a plastic kettle for hand washing and the instructions leaflet.
16055460|NCT02486523|Behavioral|Household visit|A household visit conducted by village's community health volunteers and ACF intervention staff during and after the treatment, to provide refresh training on the messages and the use of the kit.
16055461|NCT02486523|Behavioral|Group discussions after successful discharge|Group discussions on hygiene and care practices with mothers at the community level after successful discharge.
16055462|NCT02486523|Procedure|Outpatient Therapeutic Programme|Home-based treatment and rehabilitation using Ready-to-use Therapeutic Food (RUTF) for children with severe acute malnutrition
16055463|NCT02486510|Drug|Maraviroc|"Patients randomized to experimental control will start Maraviroc treatment before, during and after chemotherapy until lymphocytes level recovery.
~Maraviroc Dose: 300 mg/12 hours For patients receiving an HIV-protease inhibitor (except tipranavir or Fosamprenavir), the dose will be reduced to 150 mg/12hours For patients receiving Efavirenz dose the dose will be 600 mg/12hours"
16055464|NCT02486497|Biological|hENT1|hENT1 is a membrane transporter for gemcitabine. According to the hENT1 staining, patients will be treated with gemcitabine or 5-FU.
16055465|NCT02486484|Drug|ziv-aflibercept|zaltrap injection
16055466|NCT02486471|Procedure|Monsel´s Paste|surgical method to stop bleeding by using the hemostatic Agent monsel´s paste until no more bleeding is visible
16055467|NCT02486471|Other|Wait and see|finishing examination without hemostatic intervention, awaiting spontaneous coagulation
16055468|NCT02486458|Drug|5% sodium fluoride varnish|Fluoride varnish containing 22,600 ppm F, as NaF, in a neutral base
16055469|NCT02486458|Drug|1.23% sodium fluoride acidic gel|Fluoride gel containing 12,300 ppm F (as NaF) in an acidic pH (by addition of phosphoric acid)
16055470|NCT02486445|Drug|Rivaroxaban|Rivaroxaban 15 mg every 12 hours until the completion of the diagnostic work-up, which should not exceed 24 hours (maximum 2 tablets)
16055471|NCT02486432|Drug|Levodopa/Carbidopa (Sinemet)|Oral administration of 2 × 12.5 mg/50 mg Sinemet® tablet containing 13.5 mg carbidopa (equivalent to 12.5 mg anhydrous carbidopa) and 50 mg levodopa three times a day on Day -1 with 240 mL water Oral administration of 1 × 12.5 mg/50 mg Sinemet® tablets containing 13.5 mg carbidopa (equivalent to 12.5 mg of anhydrous carbidopa) and 50 mg levodopa administered with 100 mL water every hour for 16 hours on Day 1
16055472|NCT02486419|Other|Outdoor weather|Seasonal changes in temperature
16055473|NCT02486406|Drug|Ombitasvir/paritaprevir/ritonavir|Film-coated tablet for oral use
16055474|NCT02486406|Drug|Dasabuvir|Film-coated tablet for oral use
16055475|NCT02486406|Drug|Ribavirin|Film-coated tablet for oral use
16055476|NCT02486406|Drug|Ombitasvir mini tablet|Film-coated tablet for oral use
16055477|NCT02486406|Drug|Paritaprevir mini tablet|Film-coated tablet for oral use
16055478|NCT02486406|Drug|Ritonavir mini tablet|Film-coated tablet for oral use
16055479|NCT02486406|Drug|Dasabuvir mini tablet|Film-coated tablet for oral use
16055480|NCT02486406|Drug|Ribavirin solution|Oral solution
16055481|NCT02486393|Procedure|Parotid surgery|Surgery of the parotid gland tumours
16055482|NCT02486380|Device|Simplus/Eson|Released product Simplus and Eson masks
16055483|NCT02486367|Drug|Clopidogrel|Standard ADP receptor blockade
16055484|NCT02486367|Drug|Ticagrelor|High potency ADP receptor blockade
16055485|NCT02486354|Drug|icotinib|Patients were administered with oral icotinib (tablet form, 125 mg) three times daily within two days after enrollment until disease progression or unacceptable toxicity.
16055486|NCT02486341|Drug|Insulin|Continuous glucose monitoring system over 120-hour period.
16055487|NCT02486328|Drug|Midazolam|Dosage adjustment
16055488|NCT02486328|Drug|Meperidine|Dosage adjustment
16055489|NCT02486328|Drug|Remifentanil|Dosage adjustment
16055490|NCT02486328|Drug|Propofol|Dosage adjustment
16055535|NCT02485938|Drug|Allogeneic Cardiosphere-Derived Cells (CAP-1002)|Intracoronary delivery of Allogeneic Cardiosphere-Derived Cells (CAP-1002)
16055536|NCT02485925|Device|THERMOCOOL® SMARTTOUCH™|Pulmonary vein isolation by RF ablation treatment with the THERMOCOOL® SMARTTOUCH™ contact force sensing catheters (study device)
16055491|NCT02486315|Device|AXXESS stent|Axxess stent is a conically-shaped, self-expanding nitinol stent, with a 0.006-inch strut thickness, specifically designed to preserve and to match the anatomy of the bifurcation at the carina level. The stent is coated with Biolimus A9™, a highly lipophilic, semi-synthetic sirolimus analogue, immersed in the biodegradable polylactic acid (PLA) applied primarily to the abluminal surface. PLA completely dissolves after 6 to 9 months.The stent has 3 radiopaque markers at the distal end and one at the proximal end to aid in the visibility and placement. The AxxessTM stent is 7 Fr guiding catheter or Sheathless Guiding Catheter compatible. During the study period, the AxxessTM stent was available in 3 different diameters (3.0, 3.5 and 4.0 mm) and lengths (9, 10 and 14 mm)
16055492|NCT02486302|Drug|Etanercept|Etanercept shall be used according to clinical practice and in line with the summary of product characteristics.
16055493|NCT02486289|Drug|Emeramide|Mercury chelator NBMI ((N1,N3-bis(2-mercaptoethyl) isophthalamide)
16055494|NCT02486289|Drug|Placebo|NBMI Placebo
16055495|NCT02486276|Drug|Cilostazol|Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
16055496|NCT02486276|Drug|Sumatriptan|Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
16055497|NCT02486276|Drug|Placebo|Cilostazol is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
16055498|NCT02486263|Other|Study Arm - acid suppression plus feeding bundle|"Omeprazole 0.5-1.5 milligrams/kilogram/dose twice a day (BID)
~Total fluid volume restriction (120-140 milliliters/kilogram/day)
~Feeding duration over 30 minutes
~Infant feeds with right side down
~Infant is placed on back following feeds"
16055499|NCT02486263|Other|Conventional arm - acid suppression only|-Omeprazole 0.5-1.5 milligrams/kilogram/dose twice a day (BID)
16055500|NCT02486250|Other|Validation Study|
16055501|NCT02486237|Other|None, observational study|None, it is an observational study
16055502|NCT02486224|Dietary Supplement|Kona Deep|Subjects will receive Kona Deep post exercise
16055503|NCT02486224|Dietary Supplement|Spring Water|Subjects will receive Spring Water post exercise
16055504|NCT02486224|Dietary Supplement|Sports Drink|Subjects will receive Sports Drink post exercise
16055505|NCT02486211|Drug|Amantadine|100mg twice per day for 7 days at 0600 and 1200
16055506|NCT02486211|Drug|Placebo|Placebo comparator
16055507|NCT02486198|Drug|placebo|"For patients with oxaliplatin-based chemotherapy(every 2 or 3 weeks), equal saline as placebo should be used one hour before oxaliplatin for 1 week during every chemotherapy cycle, until neurotoxicity progressed.
~For patients who discontinue oxaliplatin-based chemotherapy, equal saline as placebo should be used daily until there is no neurotoxicity relief (neurotoxicity should be assessed at 2 and 4 weeks' treatment, up to 18 weeks)"
16055508|NCT02486198|Drug|GM|"For patients with oxaliplatin-based chemotherapy(every 2 or 3 weeks), monosialotetrahexosylganglioside sodium injection(40mg for chemotherapy of every 2 weeks or 60mg for chemotherapy of every 3 weeks)should be used one hour before oxaliplatin for 1 week during every chemotherapy cycle, until neurotoxicity progressed.
~For patients who discontinue oxaliplatin-based chemotherapy, equal monosialotetrahexosylganglioside sodium injection should be used daily until there is no neurotoxicity relief (neurotoxicity should be assessed at 2 and 4 weeks' treatment, up to 18 weeks)"
16055509|NCT02486198|Drug|oxaliplatin-based chemotherapy|chemotherapy contains oxaliplatin
16055510|NCT02486185|Other|SCREENING TEST|"Skeletal muscle mass, which will be estimated by calculating values for the mid-arm muscle circumference (MAMC) from brachial perimeter (BP) and triceps skinfold thickness (TSF).
~Muscle force will be measured using a hydraulic dynamometer
~Physical performance will be estimated from the subject's Gait speed using a 4 meter gait test (Gait speed 4-m)"
16055511|NCT02486172|Behavioral|Peer support program|Peer support program as an additional service to the routine clinical service
16055512|NCT02486159|Drug|Herbal plaster (Sanfujiu)|The Acupoint herbal plaster consisted of mustard seed, fumarate, asarum, angelica, cinnamon, and ginger at a ratio of 3:3:2:2:0.5:4, respectively. The treatment was prepared by dissolving the ginger in water and adding the powder to form a plaster. Mixtures were formed into cakes of approximately 1.5 × 1.5 × 0.5 cm3 and were held in position using plastic sheets.
16055513|NCT02486159|Procedure|Acupuncture|Eight (8) acupuncture treatment sessions over 4 weeks were performed for each volunteer. The standard protocol for acupuncture treatment covered the most commonly treated acupoints for allergic rhinitis: LI4, ST36, LI20 in both sides, and EX-HN3. After insertion of needles at each acupoint, manual stimulation of needles on LI20 and EX-HN3 was repeated 3 times at 5-minute intervals. Electrostimulation was applied to the needles inserted in ST36 and LI4 with a frequency of 3-5 Hz, and the intensity was adjusted according to each volunteer's tolerance. All needles were removed 20 minutes later in each treatment session.
16055514|NCT02486133|Drug|Prezista|once daily
16055515|NCT02486133|Drug|Norvir|once daily
16055516|NCT02486133|Drug|Tivicay|once daily
16055517|NCT02486133|Drug|Truvada|once daily
16055518|NCT02486133|Drug|Kivexa|once daily
16055519|NCT02486107|Procedure|surgical procedure|
16055520|NCT02486081|Device|smart soccer ball|smart soccer ball was used to measure participant's performance in total time and distance for completion, and acceleration
16055521|NCT02486068|Device|ABSORB scaffold|
16055522|NCT02486068|Device|Xience|
16055523|NCT02486055|Drug|BPM31510 Oral Nanosuspension 4%|Oral nanosuspension formulation of BPM31510 (ubidecarenone, USP)
16055524|NCT02486042|Drug|Omegaven|
16055525|NCT02486042|Drug|Standard Nutrition|
16055526|NCT02486016|Drug|Duragesic reference fentanyl TDS|25 µg/hour
16055527|NCT02486016|Drug|Apotex generic fentanyl TDS|25 µg/hour
16055528|NCT02486016|Drug|Mylan generic fentanyl TDS|25 µg/hour
16055529|NCT02485990|Drug|Tremelimumab|
16055530|NCT02485990|Drug|Olaparib|
16055531|NCT02485977|Device|Magnetic resonance Imaging|MRI study will be performed on 1.5 Tesla magnet, during the administration of Gadolinium
16055532|NCT02485964|Other|Blood draw|One time blood draw at time of consent. Blood will be stored until all subjects have been enrolled and then the enzyme-linked immunospot (ELISPOT) assay will be done to measure the antigen-specific interferon secretion.
16055533|NCT02485951|Procedure|Central air injection|Air was injected inside the trephination site in the central injection group.
16055537|NCT02485912|Biological|ChAd3-EBO Z|This is a viral vectored vaccine using a chimpanzee adenovirus as a vector encoding a Zaire strain Ebola glycoprotein
16055538|NCT02485912|Biological|MVA-EBO Z|This is a viral vectored vaccine using a modified vaccinia Ankara virus as a vector encoding a Zaire strain Ebola virus glycoprotein
16055539|NCT02485899|Biological|BMN 190|300 mg ICV infusion administered every other week for up to 240 weeks
16055540|NCT02485899|Device|Intraventricular Access Device|Surgical implantation of an MRI compatible ICV access device in the lateral ventricle of the right hemisphere is required for administration of study drug.
16055541|NCT02485886|Drug|68Ga-BMV101|68Ga-BMV101 were intravenously injected into the patients 1 h before the PET/CT scans.
16055542|NCT02485873|Drug|Rivaroxaban (Xarelto, BAY59-7939)|As prescribed by treating physicians
16055543|NCT02485873|Drug|Vitamin K antagonists|As prescribed by treating physicians
16055544|NCT02485860|Device|Melectis G|
16055545|NCT02485847|Procedure|Ophthalmology|A registry of ophthalmic ambulatory encounters which captures essential data elements for continuous quality improvement efforts, enhanced patient care outcomes, and pay for performance programs.
16055546|NCT02485834|Procedure|FDG-PET|
16055547|NCT02485834|Procedure|surgery|
16055548|NCT02485834|Drug|5-FU|200 mg/m^2/day IV
16055549|NCT02485834|Drug|capecitabine|oral 800 mg/m^2 BID
16055550|NCT02485834|Drug|docetaxel|30 mg/m^2 IV
16055551|NCT02485834|Drug|Irinotecan|50 mg/m^2 IV
16055552|NCT02485834|Radiation|3D-CRT|
16055553|NCT02485834|Radiation|IMRT|
16055554|NCT02485821|Drug|Estradiol|
16055555|NCT02485821|Drug|Placebo|
16055556|NCT02485821|Drug|Misoprostol|
16055557|NCT02485808|Other|None-observational|For surgical patients, follow-up assessments will occur 3 and 12 months after the surgery. For medical patients, follow-up assessments will occur 3 and 12 months after the baseline assessment.
16055558|NCT02485808|Procedure|Magnetic Resonance Imaging (MRI)|One time MRI scanning session examining brain structure and function in a resting state and after water consumption.
16055559|NCT02485808|Other|Multimodal Automated Sensory Testing System|Pressure pain thresholds will be assess using computer-controlled pressures delivered by a device called the Multimodal Automated Sensory Testing System (MAST) device on to the subjects thumbnail bed.
16055560|NCT02485808|Other|Auditory Sensitivity Test|Subjects' sensitivity to sound will be evaluated using a series of sounds delivered by a standard audiometer device.
16055561|NCT02485795|Other|Observational|This study will evaluate the impact of genetic testing information on medical regimen plans and whether this information results in benefits to patient care.
16055562|NCT02485782|Device|CardioScreen 1000 - Haemodynamic Measurement System, Medis|Impedance cardiography (ICG)
16055563|NCT02485782|Device|BCM- Body Composition Monitor, Fresenius Medical Care|Information about the individual fluid status and the nutritional status.
16055564|NCT02485782|Device|SCHILLER, BR-102 plus, Ambulatory Blood Pressure Monitoring System|Blood pressure monitoring every 15 min during hemodialysis
16055565|NCT02485769|Drug|PF-06650833|Suspension
16055566|NCT02485769|Drug|Placebo|Suspension
16055567|NCT02485769|Drug|PF-06650833|Tablet (Modified Release)
16055568|NCT02485769|Drug|Placebo|Tablet (Modified Release)
16055569|NCT02485756|Other|Educational handout|Topics include: interactions between AED and certain hormonal contraceptives, Center for Disease Control and Prevention (CDC) recommendations for alternative contraceptive methods that are not known to interact with AEDs, contraceptive failure rates
16055570|NCT02485743|Other|Active Diet Products|A range of Active Diet Products that will be provided as part of a weight maintenance diet which contain active ingredients aimed at increasing satiety (such as inulin, β-glucan, protein, and mycoprotein). All ingredients are accepted food ingredients approved for human consumption in Europe.
16055571|NCT02485743|Other|Placebo Diet Products|A range of Placebo Diet Products matching those provided in the Active Diet which will be provided as part of a weight maintenance diet but do not contain additional ingredients aimed at improving satiety (food matrices will be the same - e.g. shakes, cheeses etc but without active ingredients).
16055572|NCT02485717|Drug|spinosad topical suspension, 0.9%|Topically apply 0.9% suspension up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours.
16055573|NCT02485717|Other|Placebo|Placebo is the same as the drug minus the active ingredient spinosad (vehicle). Topically apply up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours.
16055574|NCT02485704|Drug|spinosad topical suspension, 0.9%|Topically apply 0.9% suspension up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours.
16055575|NCT02485704|Other|Placebo|Placebo is the same as the drug minus the active ingredient spinosad (vehicle). Topically apply up to 120 mL (enough to cover the body from the neck down to the soles of the feet). One application for six hours.
16055576|NCT02485691|Drug|cabazitaxel XRP6258|Pharmaceutical form:solution Route of administration: intravenous
16055577|NCT02485691|Drug|enzalutamide|Pharmaceutical form:capsule Route of administration: oral
16055578|NCT02485691|Drug|abiraterone acetate|Pharmaceutical form:tablet Route of administration: oral
16055579|NCT02485691|Drug|prednisone|Pharmaceutical form:tablet Route of administration: oral
16055580|NCT02485678|Other|Proactive Telephone Toxicity Management|Centres randomized to this arm will implement a pro-active telephone toxicity management program, for all eligible early stage breast cancer patients beginning neo-adjuvant or adjuvant chemotherapy within the intervention period until the end of their systemic treatment. Patients will receive a phone call from a local nurse who has been trained on the toxicity management toolkit at 24-72 hours and at 8 to 10 days following each chemotherapy administration. The provider conducting the call will be provided with a script and will complete the Telephone Follow-Up Questionnaire which includes questions from the abbreviated NCI PRO-CTCAE tool. The nurse conducting the call will also be provided with the provider version of the symptom management booklet and provide toxicity management counseling. If any toxicity-related problems are identified during the call, a second call will take place 24 hours after the initial call to ensure the problem is resolving or to provide additional support.
16055757|NCT02484365|Other|No treatment|Attach adhesive probe on thumb or index finger
16055581|NCT02485678|Other|Control Arm|Centres randomized to the control arm will continue to provide routine care for chemotherapy-related toxicities as is the current standard in the centre.
16055582|NCT02485678|Other|PRO Sub-Study|A sub-set of approximately 25 patients enrolled at each participating centre will participate in a Patient Reported Outcomes (PRO) sub-study to assess the effect of the intervention on secondary outcomes.
16055583|NCT02485665|Device|Extracorporeal biofeedback device (Any Kegel)|Prostate cancer patients of intervention group will received extracorporeal biofeedback device (Any Kegel) for pelvic floor muscle exercise (PFME) to improve the post-prostatectomy incontinence after robot-assisted laparoscopic radical prostatectomy. Enrolled patients in intervention group should be performed PFME regularly, based on following protocols: total exercise time (10 minutes/day), intensity (1.2 kgf), tension duration (10 sec/ 1 contraction), total exercise number (4 times/day)
16055584|NCT02485652|Drug|HM61713|"800 mg QD continuously in 21-day cycles until disease progression determined by investigator assessment per RECIST version 1.1, and as long as, in the investigators opinion, they are benefiting from study treatment and they do not meet any of treatment discontinuation criteria."
16055585|NCT02485639|Biological|Influenza Virus Vaccine Inactivated|A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain. Trivalent influenza vaccine is formulated annually, based on influenza strains projected to be prevalent in the upcoming flu season. All participants will receive vaccine IM on day 1.
16055586|NCT02485626|Procedure|2D tissue doppler echocardiography|
16055587|NCT02485613|Drug|bortezominb and dexamethasone|The initial BD regimen included bortezomib (1.3 mg/m2 i.v.) and dexamethasone (40 mg i.v.) twice weekly for 2 weeks (days 1, 4, 8, and 11), which was followed by a 10-day rest period (days 12-21). The dose of bortezomib and dexamethasone can be adjusted according to the patients' condition.
16055588|NCT02485587|Behavioral|Individualized Arousal-Biofeedback|biofeedback of biological measures of arousal (electrodermal activity)
16055589|NCT02485587|Behavioral|Treatment as usual|counseling, psychoeducation
16055590|NCT02485574|Procedure|transforaminal lumbar interbody arthrodesis|Anterior bridging cages augmented with auto bone plus β-calcium phosphate + hydroxyapatite in left side of disc space and anterior bridging cages augmented with auto bone in rt side of disc space in transforaminal lumbar interbody arthrodesis.
16055591|NCT02485561|Behavioral|Health communication intervention|This study will compare the effects of adding narratives that describe personal experiences with colon cancer screening to educational information alone to explore potential differences in reactions to different role models on individuals' screening intentions and behaviors.
16055592|NCT02485561|Behavioral|Education information|Educational materials such as those from the Centers for Disease Control and Prevention are used to present educational information to participants about colon cancer and screening tests.
16055593|NCT02485548|Drug|Raltitrexed|Patients will receive IMRT and concurrent raltitrexed and cisplatin
16055594|NCT02485548|Drug|5-fluorouracil|Patients will receive IMRT and concurrent 5-Fu and cisplatin
16055595|NCT02485548|Drug|Cisplatin|All patients will receive concurrent cisplatin.
16055596|NCT02485548|Radiation|IMRT|All patients will receive IMRT
16055597|NCT02485535|Other|Laboratory Biomarker Analysis|Correlative studies
16055598|NCT02485535|Drug|Selinexor|Given PO
16055599|NCT02485522|Other|No Intervention|No intervention
16055600|NCT02485509|Drug|VM-1500/Placebo|VM-1500 or Placebo
16055601|NCT02485496|Device|Endovascular abdominal repair|
16055602|NCT02485470|Other|MPACT|Maintaining Physical Activity during Cancer Treatment
16055603|NCT02485457|Procedure|Volume loading|Volume loading with Ringer Lactate
16055604|NCT02485457|Drug|Ringer solution|
16055605|NCT02485444|Drug|Oxytocin|20 IU oxytocin in 500 ml normal saline will be infused 100 ml/h i.v. after fetus is delivered
16055606|NCT02485431|Drug|Deflazacort|
16055607|NCT02485418|Drug|Propofol|Intravenous propofol infusion at 20 mcg/kg/min for 10 minutes, followed by an increase to 30 mcg/kg/min for 10 minutes and then by an increase to 40 mcg/kg/min for 40 minutes.
16055608|NCT02485405|Other|Trier social stress test|Volunteers perform Trier social stress test
16055609|NCT02485392|Device|Da Vinci Single Site Robot-Assisted Cholecystectomy|
16055610|NCT02485392|Device|Single Incision Laparoscopic Cholecystectomy|
16055611|NCT02485379|Procedure|Prostate biopsy|"Systematic biopsies (SB) and targeted biopsies (TB) are performed in the same patients by two independent operators. In patients without abnormalities on mp-MRI, no targeted biopsies will be carried out and the detection of clinically significant cancer will be considered as negative for the TB strategy."
16055612|NCT02485366|Drug|Rejuvesol|Blood transfused during surgery will be treated with Rejuvesol.
16055613|NCT02485366|Procedure|Cardiac surgery|The study interventions will take place during a routine admission for pediatric open heart surgery. The anesthetic technique for subjects undergoing cardiac surgery is standard care and the research study interventions will not change these practices in any way.
16055614|NCT02485353|Drug|Vosaroxin and Cytarabine|
16055615|NCT02485340|Drug|5-ISMN (isosorbide-5-mononitrate)|5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
16055616|NCT02485340|Drug|Sumatriptan|5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
16055617|NCT02485340|Drug|Placebo|5-ISMN is given both study days to induce headache. One day the headache is treated with placebo and the other day with sumatriptan
16055618|NCT02485327|Drug|Technosphere Insulin SAR439065 Afrezza®|"Pharmaceutical form: dry powder
~Route of administration: oral inhalation"
16055619|NCT02485314|Other|Participation|The PEM-CY will be field-tested with a sample of 650 caregivers of children with and without disabilities residing in the Turkey.
16055620|NCT02485301|Biological|GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A)|A single dose administrated intramuscular
16055621|NCT02485301|Drug|Placebo|A single dose administrated intramuscular
16055622|NCT02485262|Drug|Sofosbuvir and simeprevir|Hepatitis C treatment using Direct Acting Agents
16055758|NCT02484352|Drug|saline|different dosage of IV oxycodone was given before intubation
16055623|NCT02485249|Drug|Dexamethasone Phosphate Ophthalmic|Transscleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis)
16055624|NCT02485236|Device|Low flow oxygen via nasal cannula|In the low flow oxygen group, patients will be supplemented with 1 liter per minute via nasal cannula. Adjustment of initial setting upon floor arrival: To adjust oxygen 1-4 liters per minute to an arterial saturation of oxygen of > 88%. Continuous oximetry will be collected up to 48 hours. Standard postsurgical care.
16055625|NCT02485236|Device|Humidified Nasal High Flow Therapy|Adjustment of initial setting upon floor arrival: To adjust oxygen 1-4 liters per minute to arterial saturation of oxygen > 88%. To adjust air flow to patient comfort (20-35 liters per minute). Continuous oximetry will be collected up to 48 hours. Standard postsurgical care.
16055626|NCT02485210|Procedure|Endodontic treatment|It will be done the endodontic treatment using the photosynamic therapy for decontamination of the root chanel.
16055627|NCT02485197|Other|7 continuous days of aerobic training|For 7 consecutive days, subjects will perform up to 45 minutes of exercise consisting of treadmill walking at a progressive intensity of about 60-65% of their maximum heart rate. This heart rate range is estimated to be below 60% VO2 max.
16055628|NCT02485184|Procedure|Transjugular intrahepatic portosystemic shunt|Transjugular intrahepatic portosystemic shunt refers to an interventional radiological procedure by placing a stent between portal vein and hepatic vein. No specific device was used in the Interventional field.
16055629|NCT02485184|Drug|Non-selective beta blockers|Non-selective beta blockers are the drugs for reducing the portal pressure.
16055630|NCT02485184|Procedure|Endoscopic therapy|Endoscopic therapy includes the endoscopic variceal band ligation
16055631|NCT02485184|Drug|Anticoagulation|Anticoagulation therapy includes heparin and warfarin.
16055632|NCT02485171|Device|SAFEWALKER|Medical device walking aids.
16055633|NCT02485158|Drug|THC|This is a within-subjects, double-blind, placebo controlled design. We administered oral THC to healthy volunteers to measure their subjective response, which we later compared to their responses to two other drugs.
16055634|NCT02485158|Drug|AMP|This is a within-subjects, double-blind, placebo controlled design. We administered AMP to healthy volunteers to measure their subjective response, which we later compared to their responses to two other drugs.
16055635|NCT02485158|Drug|ALC|This is a within-subjects, double-blind, placebo controlled design. We administered alcohol to healthy volunteers to measure their subjective response, which we later compared to their responses to two other drugs.
16055636|NCT02485158|Drug|Placebo capsules|This is a within-subjects, double-blind, placebo controlled design. We administered size 00 gelatin capsules containing dextrose to healthy volunteers as a control for when they received either amphetamine or THC.
16055637|NCT02485158|Drug|Placebo beverage|This is a within-subjects, double-blind, placebo controlled design. We administered a drink containing cranberry juice plus 1% alcohol added as a taste mask.
16055638|NCT02485145|Drug|A/B|This arm uses the test product first, which consists of Diclofenac 3%, Baclofen 2%, Orphenadrine 5%, and Bupivacaine 2% in a VersaPro cream. This is the A arm. The B arm is the second arm, and consists of the VersaPro cream alone.
16055639|NCT02485145|Drug|Placebo|The placebo, which consists of the VersaPro cream, will be utilized in the study.
16055640|NCT02485145|Drug|B/A|This arm uses the placebo product first, which consists of the VersaPro cream alone. This is the B arm. The A arm is the second arm, which consists of the test product which consists of Diclofenac 3%, Baclofen 2%, Orphenadrine 5%, and Bupivacaine 2% in a VersaPro cream. This is the A arm.
16055641|NCT02485132|Other|Observational|Investigators propose to perform a one-week baseline testing (pre-initiation of the SU), at initiation (first week after the first dose of the SU) and after a 3 months follow-up of treatment with a SU, including CGMS reading, medical history measures, quality of life and diabetes treatment satisfaction.
16055642|NCT02485119|Drug|BAY94-9343|Cohort 1: 4.5 mg/kg of BAY 94-9343 at Q3W dose regimen. Cohort 2: 6.5 mg/kg of BAY 94-9343 at Q3W dose regimen.
16055643|NCT02485106|Drug|Rifaximin|400mg three times per day for 28 days
16055644|NCT02485106|Drug|Corticosteroid or pentoxifylline|Corticosteroid 40mg/day or pentoxifylline 400mg three times per day for 28 days
16055645|NCT02485093|Device|Septal ventricular pacing|Ventricular pacing must be at least 90%, from the septum and with optimized AV delay
16055646|NCT02485093|Device|VIP|Ventricular pacing must be less than 10%.
16055647|NCT02485080|Drug|Simeprevir|
16055648|NCT02485080|Drug|Sofosbuvir|
16055649|NCT02485067|Drug|THVD-201|Combination of Tolterodine 2mg and Pilocarpine 9mg
16055650|NCT02485067|Drug|Placebo(For THVD-201)|
16055651|NCT02485067|Drug|Detrusitol 2mg tablet|Tolterodine 2mg
16055652|NCT02485067|Drug|Placebo(For Detrusitol 2mg tablet)|
16055653|NCT02485054|Other|Clinical, ophthalmological and neurological evaluation|Clinical : questionnaire about the symptoms and about the vascular risk factors Cerebral MRI, MRI angiography of the supra-aortic trunks, ECG, Holter, transthoracic echocardiography, blood count, erythrocytes sedimentation rate, C reactive protein, visual field, optical coherence tomography, retinography
16055654|NCT02485041|Drug|Dapoxetine 30mg|Tablet, Orally administered
16055655|NCT02485041|Drug|Mirodenafil 100mg|Table, Orally administered
16055656|NCT02485028|Drug|Dapoxetine 30mg tablet|
16055657|NCT02485028|Drug|Mirodenafil 50mg tablet|
16055658|NCT02485015|Biological|Cytokine-Induced Killer Cells|Cytokine-Induced Killer Cells are used to treat advanced gastric cancer patients with Apatinib.
16055659|NCT02485015|Drug|Apatinib|Advanced gastric cancer patients take Apatinib 850mg qd by mouth.
16055660|NCT02485002|Device|RIRS with ureteral access sheath|Ureteral access sheath will be used during RIRS.
16055661|NCT02485002|Device|RIRS without ureteral access sheath|Ureteral access sheath will not be used during RIRS.
16055662|NCT02484989|Other|Surviellance card|
16055697|NCT02484703|Drug|RO5186582|Participants will receive 1 of 3 dosages of RO5186582 PO BID, including 40 mg, 60 mg, or 120 mg. Study medication will first be administered on Day 1, and only the morning dose will be given on the last day of treatment (Week 26).
16055698|NCT02484690|Drug|Faricimab|Faricimab will be administered as per the regimen specified in the individual arm.
16055699|NCT02484690|Drug|Ranibizumab|Ranibizumab will be administered as per the regimen specified in the individual arm.
16056187|NCT02481310|Drug|Methotrexate|Given IT or intraventricularly
16055663|NCT02484976|Behavioral|Family Based Behavioral Treatment|Obese children accompanied by at least one parent or caregiver will attend 24 weekly in-person sessions. Sessions will include 25-30 min. meetings between an interventionist and each child/parent pair to individualize treatment, followed by separate child and parent group meetings lasting 40 - 45 min. Parents will serve as primary agents of change for their child and for themselves. Training will focus on food and physical activity education, parenting around food and physical activity, and use of behavioral skills (e.g., self-monitoring, environmental control, contingency management). Intervention groups of 9-11 children/families will be initiated every 3-6 mos. in study yrs. 1-3.
16055664|NCT02484963|Drug|Zolpidem|
16055665|NCT02484963|Drug|placebo|
16055666|NCT02484950|Biological|Mesenchymal stem cell augmentation in rotator cuff repair|Patients undergoing mesenchymal stem cell augmentation will receive a total injection of 6 milliliters (mL). Of this, 3 mL will be injected in the tendon at the junction between bone and tendon, while 3 mL will be injected in the bone at the site of the surgical footprint.
16055667|NCT02484950|Procedure|Standard arthroscopic rotator cuff repair|All patients will undergo full thickness rotator cuff repair using a double row, transosseous-equivalent (TOE) repair with anchor/suture technique. Acromioplasty will be performed in all patients. Alternate procedures such as biceps tenotomy/tenodesis and distal clavicle excision will be performed at the discretion of the surgeon and recorded.
16055668|NCT02484937|Other|Group 2 (PCP Treatment)|For the PCP group treatment will be performed (pain treatment/medications) by the Primary Care Physician in his/her office/clinic.
16055669|NCT02484937|Other|Group 1 (PMS Treatment)|For the PMS group treatment will be performed (pain treatment/medications) by the Pain Medicine Specialist in his/her office/clinic.
16055670|NCT02484924|Drug|Ticagrelor|No intervention- purely observational
16055671|NCT02484911|Drug|Olanzapine|5mg,twice a day orally on day 1 to day 4
16055672|NCT02484911|Drug|Aprepitant|125 mg capsule per oral, 1 hour before chemotherapy on day 1, 80 mg capsule daily in the morning during days 2 to 3.
16055673|NCT02484911|Drug|Palonosetron|0.25mg IV 30-60min before chemotherapy on day 1
16055674|NCT02484911|Drug|Dexamethasone|6mg IV on day 1 ，3.75mg IV on day 2 to 4
16055675|NCT02484885|Other|Hyperpolarized Xenon MRI|Hyperpolarized noble gas imaging using Xenon-129 has been used to explore structural and functional relationships in the lung in patients with lung disease and healthy controls. In contrast to proton-based MRI imaging, 129Xe gas is used as a contrast agent to directly visualize the airways, and thus ventilation. Whereas the normal density of gas is too low to produce an easily detectable signal, this is overcome by artificially increasing the amount of polarization per unit volume using optical pumping.
16055676|NCT02484859|Drug|Remifentanil|Remifentanil infusion will be started with a bolus dose of 0.5 µg/kg before the induction, and will be continued throughout the surgery at a dose of 0.25-0.5 µg/kg/min. At the end of the surgery, the rate of infusion will be decreased to 0.05 µg/kg/min, and continued until the patient is extubated.
16055677|NCT02484859|Drug|Tramadol|1 mg/kg tramadol will be added to 100 ml of isotonic fluid, and will be administered intravenously in exactly 30 minutes via a perfusor. The infusion will be started just before the induction.
16055678|NCT02484859|Drug|Metoprolol|0.1 mg/kg of metoprolol will be administered intravenously within 5 minutes following the administration of neuromuscular blocking agent.
16055679|NCT02484846|Behavioral|Time in bed|Habitual time spent in bed for the purpose of sleep was determined at baseline. This was used to calculated the experimental time in bed the subject was to spent on the one night prior to the second lab visit.
16055680|NCT02484833|Drug|Cetuximab|
16055681|NCT02484833|Drug|FOLFIRI|
16055682|NCT02484820|Device|Silicone pessary|Silicone pessary is used between 24 weeks of pregnancy and up to 6 weeks after the date of the term (maximum 6 months)
16055683|NCT02484807|Other|no intervention, only observation of different groups|
16055684|NCT02484794|Behavioral|Standard Outpatient Treatment|Standard treatment offered by the Nova Scotia Health Authority Eating Disorder Outpatient Program varies in intensity but involves therapy groups (e.g., goal setting and skill building groups), individual contact, and meal experiences. Minimal participation in the program consists of a weekly nutritional counselling group (Nutri-Logical) and one supervised meal a week. In the nutritional counselling group, patients keep a food journal (self-monitor), set eating goals, receive feedback from a psychologist and dietitian, and share experiences with the group.
16055685|NCT02484794|Behavioral|Smartphone App|The smartphone app is a mobile eating disorder self-monitoring tool that incorporates discrete reminders, positive feedback, social support, summative feedback, coping skill suggestions, and linking patients with their treating clinicians (psychologist and dietician). The app is CBT-based and was designed as an alternative to paper food records for use in clinical treatment.
16055686|NCT02484781|Other|Gait analysis on a trendmill|"Gait analysis on a trendmill GRAIL to analyse spatio-temporal kinetics and kinematics when flat walking and inclining"
16055687|NCT02484768|Drug|Iron isomaltoside 1000|Intravenous treatment
16055688|NCT02484768|Drug|Sodium Chloride 0.9%|Intravenous treatment
16055689|NCT02484755|Drug|Gefitinib|See Arm Description
16055690|NCT02484742|Behavioral|Insomnia symptom induction|Several nights during the 18-day stay will be disrupted, such that we delay sleep onset, advance sleep off set, and the sleep period will be disrupted by frequent nighttime awakenings.
16055691|NCT02484729|Drug|AZD9977, oral suspension|Single ascending doses of AZD9977 oral suspension (Part A) Single dose of AZD9977 oral suspension in IntelliCap® capsule in regional absorption part (Part B)
16055692|NCT02484729|Drug|Placebo, oral suspension|Matching placebo
16055693|NCT02484729|Drug|AZD9977, oral solution|AZD9977, single dose of oral solution in Part B as reference
16055696|NCT02484703|Drug|Placebo|Participants will receive matching placebo PO BID. Study medication will first be administered on Day 1, and only the morning dose will be given on the last day of treatment (Week 26).
16055753|NCT02484391|Procedure|Hematopoietic Cell Transplantation|Undergo stem cell transplant
16055754|NCT02484391|Drug|Mitoxantrone Hydrochloride|Given IV
16055700|NCT02484690|Drug|Sham Procedure|The sham is a procedure that mimics an intravitreal injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in treatment arm D at applicable visits to maintain masking.
16055701|NCT02484677|Drug|Cisplatin|Antineoplastic cytostatic. Blood sampling for pharmacokinetic evaluation
16055702|NCT02484677|Drug|Docetaxel|Taxanes. Blood sampling for pharmacokinetic evaluation
16055703|NCT02484677|Drug|5-Fluorouracile|Antineoplastic and immunomodulating agents. Blood sampling for pharmacokinetic evaluation
16055704|NCT02484664|Drug|Celecoxib|We will perform a pilot clinical trial to investigate the safety and tolerability of celecoxib therapy as a single agent for patients with LAM. LAM subjects who are not taking everolimus or rapamycin will be treated with celecoxib at 200mg PO QD for 6 months. They will be monitored for respiratory function and angiomyolipoma size. At the end of the 6 month period, celecoxib will be discontinued, and subjects will be monitored for another 6 months.
16055705|NCT02484651|Drug|Sugammadex|Reversal of deep neuromuscular block
16055706|NCT02484651|Drug|Rocuronium|Maintenance of deep neuromuscular block
16055707|NCT02484638|Drug|CSL689|Recombinant fusion protein, linking activated coagulation factor VII with albumin. Two dose levels (low dose, high dose) will be studied in Parts 1, 2, and 3.
16055708|NCT02484638|Drug|Eptacog alfa (activated)|Recombinant activated coagulation factor VII. Two dose levels (low dose, high dose) will be studied in Part 1.
16055709|NCT02484625|Other|Potato chips|Commercially available potato chips, 180 kcal
16055710|NCT02484625|Other|Greek yogurt|Commercially available Greek yogurt, 180 kcal
16055711|NCT02484625|Other|Cookies|Commercially available cookies, 180 kcal
16055712|NCT02484625|Other|Cheese|Commercially available cheese, 180 kcal
16055713|NCT02484625|Other|Milk|Commercially available milk, 180 kcal
16055714|NCT02484612|Behavioral|acute exercise|
16055715|NCT02484599|Behavioral|Computerized attention training (CAT)|Three sessions of active computerized attention training.
16055716|NCT02484599|Behavioral|Sham computerized attention training (control condition)|Three sessions of sham computerized attention training.
16055717|NCT02484586|Device|Etafilcon A|Prototype lens material
16055718|NCT02484586|Device|Etafilcon A|Control lens for presbyope group
16055719|NCT02484586|Device|Nelfilcon A|Control lens for presbyope group
16055720|NCT02484586|Device|Nesofilcon A|Control lens for presbyope group
16055721|NCT02484586|Device|Nelfilcon A|Control lens for non-presbyope group
16055722|NCT02484586|Device|Etafilcon A|Control lens for non-presbyope group
16055723|NCT02484586|Device|Somofilcon A|Control lens for presbyope group
16055724|NCT02484586|Device|58% Poly-HEMA|Control lens for presbyope group
16055725|NCT02484586|Device|Omafilcon A|Control lens for non-presbyope group
16055726|NCT02484573|Drug|Propanolol|
16055727|NCT02484560|Drug|Biological: Umbilical Cord Based Allogenic Mesenchymal Stem Cell|
16055728|NCT02484547|Drug|Aducanumab (BIIB037)|Low dose
16055729|NCT02484547|Drug|Aducanumab (BIIB037)|High dose
16055730|NCT02484547|Drug|Placebo|Placebo
16055731|NCT02484521|Device|PPI monitoring device protocol|The investigators would use a monitoring device that would assess startle reflex reaction measured by blinking or the eye. Monitoring would be done with electrodes of EMG device that would be located on orbicularis oculi muscle and will monitor response.
16055732|NCT02484521|Other|Questionnaires|"Group of patients diagnosed with schizophrenia would be interviewed using well validated questionnaires.
~Questionnaires what would be used are:
~GAF- Global assessment of functioning
~PANSS- Positive and negative syndrome scale
~SANS- Scale for the Assessment of Negative Symptoms
~The Calgary Depression Scale for schizophrenia
~Demographic Questionnaire
~Hamilton Anxiety scale"
16055733|NCT02484508|Drug|Guli capsule|Guli capsule,as the experimental drug,is taken 3 grains each time, 3 time per day
16055734|NCT02484508|Drug|Kangguzengsheng capsule|Kangguzengsheng capsule, as the active comparator, is taken 3 grains each time, 3 time per day
16055735|NCT02484495|Other|Program evaluation (impact assessment)|"The program activities include: processed complementary food rations which will be distributed to all children 6-23 months of age, in a grain bank based on bartering of raw materials; enhanced Infant and Young Child Nutrition (IYCN) counselling will be given to the mothers of children 6-23 month of age, using improved Behavior messages based Change Intervention (BCI) on formative research.
~Monthly 15 MNPs sachets will be provided to all children 6-23 months of age with the instruction to add them to their complementary food, to enable point-of-use fortification on every alternate day."
16055736|NCT02484482|Drug|CKD-519 200mg / Fasting, Standard Meal, High Fat Meal|
16055737|NCT02484469|Device|The Virtual Human Project|Virtual Human educational videos about leprosy
16055738|NCT02484456|Drug|AV 101 (4-Chlorokynurenine)|Glycine Receptor Antagonist
16055739|NCT02484456|Other|Placebo Comparator|Placebo
16055744|NCT02484430|Other|Laboratory Biomarker Analysis|Correlative studies
16055745|NCT02484430|Other|Pharmacological Study|Correlative studies
16055746|NCT02484430|Drug|Sapanisertib|Given PO
16055747|NCT02484417|Biological|RSV A2|Intranasal inoculation of healthy volunteers with 10^5 or 10^6.3 plaque forming units (PFU) of RSV A2.
16055748|NCT02484404|Drug|Olaparib|"Olaparib tablets will be given orally on a continuous dosing schedule. The DLT period will be one cycle, 28 days.
~MEDI4736 (Durvalumab) (3mg/kg or 10mg/kg IV) and Olaparib tablets (200 mg or 300 mg BID)
~Ph II - MEDI4736 + Olaparib at RP2D"
16055749|NCT02484404|Drug|Cediranib|"Cediranib will be given orally on a continuous dosing schedule. The DLT period will be one cycle, 28 days.
~MEDI4736 (Durvalumab) (10mg/kg IV) and Cediranib (15 mg or 20 mg or 30 mg daily)
~Ph II - MEDI4736 (Durvalumab) + Cediranib at RP2D"
16055750|NCT02484404|Drug|Durvalumab|Ph I - Durvalumab will be administered once every 2 weeks for 12 months.
16055751|NCT02484391|Drug|6,8-Bis(benzylthio)octanoic Acid|Given IV
16055752|NCT02484391|Drug|Cytarabine|Given IV
16055755|NCT02484378|Drug|CER-001|Engineered pre-beta HDL particle
16055759|NCT02484352|Drug|0.05 mg/kg of oxycodone|different dosage of IV oxycodone was given before intubation
16055760|NCT02484352|Drug|0.1 mg/kg of oxycodone|different dosage of IV oxycodone was given before intubation
16055761|NCT02484352|Drug|0.15 mg/kg of oxycodone|different dosage of IV oxycodone was given before intubation
16055762|NCT02484352|Drug|0.2 mg/kg of oxycodone|different dosage of IV oxycodone was given before intubation
16055763|NCT02484339|Drug|Radium-223 dichloride|Arm A: EBRT and timely sequential start with Radium-223 dichloride 55 kBq/kgbw (6 i.v. injections every 4 weeks) and best supportive care until progression or intolerable toxicity.
16055764|NCT02484339|Other|Conventional or high dose radiotherapy|Arm B: External beam radiotherapy (EBRT)->->conventional or high dose radiotherapy
16055765|NCT02484326|Other|Grouping by different risk stratification|A simple risk score system based on 7 baseline clinical variables divided patients into four groups
16055766|NCT02484313|Other|dietary treatments|commercially available food products
16055767|NCT02484300|Dietary Supplement|Melatonin|
16055768|NCT02484300|Other|Placebo|
16055769|NCT02484287|Device|The Integra External Drainage Catheter.|Participants will be randomly assigned to receive 1 of 3 drains, to determine the efficacy of antibiotic-impregnated vs non antibiotic-impregnated EVD catheters, in the reduction of infection rates associated with EVD use.
16055770|NCT02484287|Device|The Ventriclear EVD Antibiotic Catheter|Participants will be randomly assigned to receive 1 of 3 drains, to determine the efficacy of antibiotic-impregnated vs non antibiotic-impregnated EVD catheters, in the reduction of infection rates associated with EVD use.
16055771|NCT02484287|Device|The Codman Bactiseal EVD Catheter Set|Participants will be randomly assigned to receive 1 of 3 drains, to determine the efficacy of antibiotic-impregnated vs non antibiotic-impregnated EVD catheters, in the reduction of infection rates associated with EVD use.
16055772|NCT02484274|Biological|Blood samples|1 blood sample of 9 ml. 3-day food diary , according to the European Food Safety Authority methodology
16055773|NCT02484261|Drug|Bortezomib|1.3 mg/m2/dose subcutaneously (SQ) daily (total 4 doses) on Days 1, 4, 8 and 11 (+/- 1 day with at least 72 hours between doses) q3 weeks. (For patients continuing to receive drug in cycles 6 or greater, at investigator discretion, the schedule may be changed to 1.3 mg/m2/dose SQ daily (total 3 doses) on Days 1, 8, and 15 (+/- 1 day with at least 72 hours between doses) every 4 weeks in an effort to decrease risk of peripheral neuropathy.)
16055774|NCT02484261|Drug|Pravastatin|10 mg for age < 8 years, 20 mg for age 8-<13 years, 40 mg for ages >14 years
16055775|NCT02484248|Drug|Ketotifen|Ketotifen is an anti-histamine approved by the U.S. FDA to prevent and treat itching of the eyes caused by allergies.
16055776|NCT02484248|Drug|Placebo|The placebo tablet looks identical to the ketotifen tablet, but does not contain ketotifen.
16055777|NCT02484235|Other|HIIT|Group training with HIIT 3 times per week during 10 sessions
16055778|NCT02484235|Other|Strength|Group training with strength exercises 3 times per week during 10 sessions
16055779|NCT02484222|Drug|Fentanyl|Before the end of the procedure, spontaneous respiratory was recovered. All the patients were given 1 mcg/kg fentanyl i.v. after the end of the procedure.
16055780|NCT02484209|Drug|Metformin|Metformin 1500 mg daily for 16 weeks
16055781|NCT02484209|Drug|Glimepiride|glimepiride 2-4 mg twice daily for 16 weeks
16055782|NCT02484209|Drug|Metformin|metformin 1500 mg daily for 16 weeks
16055783|NCT02484196|Behavioral|Questionnaires|Questionnaires
16055784|NCT02484183|Device|bubble continuous positive airway pressure (CPAP)|This study will use an Airsep® oxygen concentrator and a Fisher & Paykel Bubble CPAP (bCPAP) system to deliver bCPAP. The Airsep® machine is connected to the Fischer & Paykel Bubble CPAP system and the CPAP delivers pressure and oxygen to the patient with appropriately sized masks and tubing. The Fischer & Paykel Bubble CPAP system can deliver up to 10 centimeters (cm) water (H20) pressure. Since an oxygen concentrator is being used as the flow driver of this bubble CPAP system patients receiving CPAP will therefore also be receiving 6-8 liters per minute (LPM) of concentrated oxygen flow. Per manufacturer specifications the Airsep oxygen concentrator delivers 90-97% fractional inspired oxygen concentration at the 6-8 LPM flows required to generate 4-10 cm H20 pressure.
16055785|NCT02484170|Drug|Mannitol cream|Apply to area of postherpetic neuralgia pain as needed for pain control. Usual frequency is 2 to 3 times per day.For crossover study, will be applied for 7 days. For observational study, will be applied up to 3 months
16055786|NCT02484170|Drug|Placebo|Apply to area of postherpetic neuralgia pain as needed for pain control.Usual frequency is unknown. For crossover study, will be applied for 7 days. Will not be used after crossover study
16055787|NCT02484157|Device|Hemochron|Activated coagulation time was checked serially by Hemochron Jr.
16055788|NCT02484157|Device|ACT Plus|Activated coagulation time was checked serially by ACT Plus.
16055789|NCT02484144|Other|modern information|information by video for coronarography
16055790|NCT02484144|Other|usual information|usual information for coronarography
16055791|NCT02484131|Behavioral|Educational materials/mail|Participants in this group will receive any educational materials by mail during hte follow-up period.
16055792|NCT02484131|Behavioral|Educational materials/participant choice|Participants in this group will not receive any educational materials by participant choice during hte follow-up period.
16055793|NCT02484118|Procedure|Hemodialysis blood flow|The impact of blood flow rates of 320 ml/m and 380 ml/m will be compared to determine any impact on hemodialysis urea clearance
16055794|NCT02484105|Behavioral|Comforting Conversation|Pain management, distraction, diversion, empathy. Dependent on qualitative study results.
16055795|NCT02484105|Behavioral|Standard Communication|Information on procedure type, duration, findings, key landmarks, possibility of analgesic treatment, pause in procedure.
16055796|NCT02484092|Biological|SPK-9001|A novel, bioengineered adeno-associated viral vector carrying human factor IX variant
16055797|NCT02484079|Procedure|Polypectomy|
16055798|NCT02484066|Device|VBN|VBN is carried out by a VBN software（DirectPath; Olympus, Japan) which can automatically create virtual bronchoscopic images.
16055799|NCT02484066|Device|EBUS-GS|EBUS is performed using an endoscope ultrasound system , which is equipped with a 20-MHz mechanical radial-type probe (UM-S20-17S;Olympus) with an external diameter of 1.4 mm and a GS (K-201; Olympus).
16055985|NCT02482805|Behavioral|Cognitive Behavioral Therapy|Exposure therapy for social anxiety disorder
16055800|NCT02484066|Device|X-ray|The radiograph fluoroscopy are performed when the probe and GS are confirmed to reach the lesion by EBUS images ,cytologic and pathologic specimens are obtained under fluoroscopic guidance.
16055801|NCT02484053|Drug|Rituximab|Giving rituximab as a rapid infusion over a period of 90 or 120 minutes.
16055802|NCT02484040|Radiation|Two-week course of radiation|33 Gy in 10 fractions for 2 weeks
16055803|NCT02484040|Drug|Two-week course of radiation|oral capecitabine, 825mg/m2, bid
16055804|NCT02484027|Drug|Rosuvastatin|Patients will be randomly assigned to receive 2 different therapies for the first 3 days of hospitalization: no statins (non-statin-therapy group) or to immediately receive rosuvastatin orally at a dose of 20mg daily (statin-therapy group). From the fourth day onward, rosuvastatin 10 mg daily will be administered in all patients for 1 year
16055805|NCT02484014|Other|Tarang Adolescence Education programme|The comparison arm involves 'usual care' which in the study setting is the Tarang: Adolescence Education Programme comprising of 16 classroom sessions on process of growing-up, prevention of HIV/AIDS and other Sexually Transmitted Diseases (STDs), and prevention of substance and other drug abuse. This programme is delivered by a trained nodal teacher in the school over the academic year.
16055806|NCT02484014|Other|SEHER Intervention|"The SEHER intervention will be delivered by a trained teacher, called as Teacher-as-SEHER Mitra (Mitra meaning friend) or lay health worker called as SEHER Mitra being trained to facilitate following activities:
~Awareness generation activities for all stakeholders in school
~Wall-magazine
~Speak-out box
~Competitions
~School Health Promotion Committee
~School health policies
~Peer groups of students of standard IX
~Workshops and talks for all the students from standard IX, and for teachers
~Counselling and referral services for all the students in the school This intervention will be delivered in each school over the academic year."
16055807|NCT02484001|Drug|ESL 800 mg|one (1) tablet of 800 mg (QD).
16055808|NCT02484001|Drug|ESL 1200 mg|one (1) and a half tablets of 800 mg (QD). ESL tablets are scored and can be divided in two equal halves (each one containing 400 mg ESL)
16055809|NCT02484001|Drug|ESL 1600 mg|two (2) tablets of 800 mg (QD).
16055810|NCT02484001|Drug|ESL 400 mg|half tablet of 800 mg (QD). ESL tablets are scored and can be divided in two equal halves (each one containing 400 mg ESL)
16055811|NCT02483988|Device|NUsurface® Meniscus Implant|The NUsurface® Meniscus Implant is a Polycarbonate-Urethane (PCU)-based device reinforced with high tensile Ultra High Molecular Weight Polyethylene (UHMWPE) fibers. The product is available in different sizes, left and right, and with trials so as to allow the surgeon several size options for implantation. The NUsurface® Meniscus Implant, is designed to be conceptually analogous to the natural meniscus whose structural characteristics include a highly orientated collagen fiber network that supports the large hoop stresses to produce better distribution of contact pressures within the knee joint. Restoring the distribution of joint loads post-meniscectomy is thought to reducing joint overload and to reducing pain.
16055812|NCT02483975|Drug|FF|FF will be provided as a dry powder inhaler with 30 doses per device, each containing 50 mcg of FF as a dry white powder per blister, to be inhaled orally via ELLIPTA.
16055813|NCT02483975|Drug|Placebo|Placebo will be provided as dry powder inhaler with 30 doses per device, each containing placebo as a dry white powder per blister, to be inhaled orally via ELLIPTA.
16055814|NCT02483975|Drug|Montelukast|Montelukast will be provided as 4 mg and 5 mg chewable tablets.
16055815|NCT02483975|Drug|Albuterol/Salbutamol|Albuterol/Salbutamol will be provided as inhalation aerosol.
16055816|NCT02483962|Other|Gelatine capsule|Gelatine capsules containing no active ingredients.
16055817|NCT02483962|Other|Venavine Intensive®|Gelatine capsules containing 360 mg red vine leaf extract, 60 mg of horse chestnut extract, 35 mg of butchers broom extract and 3,2 mg of vitamin B6.
16055818|NCT02483949|Behavioral|Healthy Eating and Active Living for Diabetes - Gestational Diabetes Mellitus|
16055819|NCT02483936|Drug|Olmesartan medoxomil 40mg + chlorthalidone 12,5mg|1 tablet a day
16055820|NCT02483936|Drug|Olmesartan medoxomil 40mg + chlorthalidone 25mg|1 tablet a day
16055821|NCT02483936|Drug|Olmesartan 40mg + Hydrochlorothiazide 12,5mg|1 tablet a day
16055822|NCT02483936|Drug|Olmesartan 40mg + Hydrochlorothiazide 25mg|1 tablet a day
16055823|NCT02483923|Drug|Ultrasound guided serratus anterior block with ropivacaine|After induction of anesthesia, patients take ultrasound guided serratus anterior plane block with 0.5ml/kg of ropivacaine 0.375%. 30minutes before the end of operation, intravenous patient controlled analgesia (Basal rate 0ml/hr, 0.5mcg/kg of fentanyl, lock-out time 10minutes) is connected to patient.
16055824|NCT02483923|Drug|intravenous PCA only|same dose of intravenous patient controlled analgesia (Basal rate 0ml/hr, 0.5mcg/kg of fentanyl, lock-out time 10minutes) is connected to patient only.
16055825|NCT02483910|Behavioral|Direct Instruction-Language for Learning (DI-LL) via telehealth (e.g., Zoom or WebEx)|"DI-LL is composed of up to 150 lessons (15 sets of 10 lessons each - e.g., lessons 1-10, 11-20, 21-30, etc.) that build on one another. The program uses demonstrations and pictures to expand vocabulary and teach language skills to children in manageable steps. The curriculum focuses on teaching spoken language across six areas: actions, description of objects, general information, standardized prompts (show me or point to or say the whole thing), classification, and problem-solving strategies. For example, DI-LL moves from the identification of familiar objects to the description and classification of these objects. Children learn the precise meaning of both familiar and new concepts and use these concepts in statements and questions. The DI-LL also incorporates 15 assessment tests (one for each set of 10 lessons). These assessment tests are given after each set of 10 lessons to confirm mastery of the material and the child's readiness to move on to the next set of 10 lessons."
16055826|NCT02483910|Behavioral|Standard of care delivered via telehealth (e.g., Zoom or WebEx)|Usual care including speech therapy in school, community or both
16055827|NCT02483897|Drug|Tetracaine 0.5% ophthalmic drops|0.8 mls. drops provided to be used hourly p.r.n. for pain control
16055828|NCT02483897|Drug|Normal Saline placebo drops|0.8 mls. drops provided to be used hourly p.r.n. for pain control
16055829|NCT02483884|Drug|[68Ga]RM2|[68Ga]RM2 is a novel 68Ga labeled, radiopharmaceutical agent for PET imaging. It is administered intravenously as a single dose of 140 MBq (corresponding to ≤ 40 μg mass dose)
16055830|NCT02483884|Procedure|PET/CT|Patients received [68Ga]RM2 undergo PET/CT 60 min p.i. for at least 20 min
16055831|NCT02483871|Drug|Rosuvastatin|
16056188|NCT02481310|Drug|Prednisone|Given PO
16055832|NCT02483858|Drug|PQR 309|Intervention of this drug may include safety, tolerability, PK (pharmacokinetics) and efficacy
16055833|NCT02483845|Drug|Natalizumab|
16055834|NCT02483832|Behavioral|Educational materials|Educational materials about colorectal cancer and how to get screened will be presented to participants, with either gain- or loss-frame messages associated.
16055835|NCT02483806|Procedure|PEEP|After induction of anesthesia, including insertion of TEE probe, change position from supine to lateral position. Measure ABGA and cardiac indices for the baseline value. Apply each PEEP (0, 5, 10 cmH2O) serially at the random order. 6 sequences (0->5->10, 0->10->5, 5->10->0, 5->0->10, 10->5->0, 10->0->5) are equally applied to 6 patients (total 6x6=36 patients) who agreed to this study. Measure ABGA and cardiac indices after 20 min at each step of peep apply(3 times).
16055836|NCT02483793|Drug|Tamsulosin|
16055837|NCT02483793|Drug|Oxybutynin|
16055838|NCT02483780|Behavioral|Storytelling|The intervention will center on stories about living with hypertension, with patients speaking in their own words.
16055839|NCT02483767|Drug|goserelin|Gonadotropin-Releasing Hormone Agonist
16055840|NCT02483767|Drug|standard chemotherapy|(Anthracyclines/cyclophosphamide) followed by paclitaxel or doxetaxel; doxetaxel/cyclophosphamide; doxetaxel or paclitaxel/Anthracyclines; fluorouraci/Anthracyclines/cyclophosphamide followed by doxetaxel or paclitaxel; doxetaxel/Anthracyclines/cyclophosphamide; Anthracyclines/cyclophosphamide;
16055841|NCT02483741|Biological|Manuka Honey|This material is going to be placed into the sockets of the extracted third molars in the experimental group
16055842|NCT02483728|Other|Patch Test|Patch testing is a technique used to diagnose an allergic skin disease called allergic contact dermatitis. It attempts to reproduce in small scale allergic reactions of the skin from things that come in contact with it.This is the standard of care to determine allergic contact dermatitis.
16055843|NCT02483715|Drug|High-dose dual therapy (rabeprazole, amoxicillin)|High-dose dual therapy ( rabeprazole 20 mg qid + amoxicillin 750 mg qid for 14 days)
16055844|NCT02483715|Drug|Bismuth-containing quadruple therapy (rabeprazole, tripotassium dicitrate bismuthate, metronidazole, tetracycline)|Bismuth-containing quadruple therapy (rabeprazole 20 mg bid + tripotassium dicitrate bismuthate 300 mg qid + metronidazole 250 mg qid + tetracycline 500 mg qid for 10 days)
16055845|NCT02483702|Other|Irradiated Blood Transfusions|Same as arm description - need to collect extracellular potassium values.
16055846|NCT02483702|Other|Non-Irradiated Blood Transfusions|Same as arm description - need to collect extracellular potassium values.
16055847|NCT02483689|Drug|Pre Incisional Local Anesthetic|Patient will be given a total of 0.5 mL/kg of 0.25% Bupivicaine either pre-incision: local will be to be given intradermally and onto the peritoneum under direct vision; or post-closure local will be injected intradermally after closure
16055848|NCT02483689|Other|Pre-Incisional Saline|Patient will be given a max of 30 cc injected through a 22g needle to area of incision.
16055849|NCT02483689|Drug|Post-Closure Local Anesthetic|Patient will be given a total of 0.5 mL/kg of 0.25% Bupivicaine either pre-incision: local will be to be given intradermally and onto the peritoneum under direct vision; or post-closure local will be injected intradermally after closure
16055850|NCT02483689|Other|Post-Closure Saline|Patient will be given a max of 30 cc injected through a 22g needle after closing sutures were made.
16055851|NCT02483676|Device|Treadmill plus anklebot|This intervention employs the use of the adaptive anklebot control system to complement treadmill exercise training over a 6-week intervention period.
16055852|NCT02483676|Behavioral|Treadmill only|This intervention employs the use of a treadmill for gait exercise training over a 6-week intervention period
16055853|NCT02483663|Device|Functional Magnetic Resonance Imaging|Measure brain activity.
16055854|NCT02483663|Radiation|Dual Energy X-ray absorptiometry|Body composition measurements.
16055855|NCT02483663|Other|Questionnaires|Questionnaires related to: health, weight, sleep, mood, dietary habits, attitudes towards eating, how you describe yourself.
16055856|NCT02483663|Other|Mood and Appetite Ratings|Answer questions about how you are feeling at the moment.
16055857|NCT02483663|Other|Test Meals|Breakfast, a snack, and lunch provided during study visit.
16055858|NCT02483663|Other|Computer Tests|Perform a series of computer tests to determine reaction time.
16055859|NCT02483663|Procedure|Intravenous Catheter (IV) placement|Blood samples collected throughout regular intervals during the study visit day to measure levels of hormones involved in regulating appetite and body weight. We will also determine if twins are fraternal or identical and will examine DNA to see if participants carry two genes that affect appetite or body weight, the FTO gene and the MC4R gene.
16055860|NCT02483637|Device|RejuvenAir|Device: RejuvenAir
16055861|NCT02483624|Drug|BR-DIM|DIM, a condensation product of indole-3-carbinol (IC3), is a phytochemical that has activity against certain tumor cells. Observations in lupus-prone mice treated with indole-3-carbinol suggest that DIM might have favorable biologic and clinical effects in human SLE.
16055862|NCT02483624|Drug|Placebo|Placebo
16055863|NCT02483611|Drug|Magnesium Sulfate|
16055864|NCT02483611|Drug|Lidocaine|
16055865|NCT02483611|Drug|Isotonic Solution|
16055866|NCT02483611|Drug|Cisatracurium|
16055867|NCT02483598|Drug|Buspirone|The primary aim of this study is to compare the relative difference between the area-under-the-curve (AUC) of buspirone alone (buspirone) with the AUC of buspirone in the presence of grapefruit juice (buspirone + GFJ) in patients who underwent RYGB 9-18 months prior versus a control group of participants who have not undergone bariatric surgery.
16055868|NCT02483598|Drug|Buspirone and Grapefruit Juice|Grapefruit juice will be given before and during buspirone administration to inhibit intestinal CYP3A4.
16055869|NCT02483585|Drug|Erenumab|Administered once a month by subcutaneous injection
16055870|NCT02483585|Drug|Placebo|Administered once a month by subcutaneous injection
16055871|NCT02483572|Behavioral|Functional Communication Training|Functional communication training (FCT) is the most widely used treatment for severe destructive behavior that is maintained by social reinforcement, such as access to attention, tangible items, or escape from nonpreferred activities. Once clinicians determine the functional reinforcer for destructive behavior, the clinician can then teach the child an appropriate, functionally-equivalent response (e.g., exchanging a card to access parental attention) and the clinician would no longer provide the functional reinforcer for destructive behavior.
16055872|NCT02483559|Other|Amber Lenses|Glasses fitted with amber lenses that block the blue spectrum of light (~470 nm) to be worn prior to desired sleep onset time.
16055873|NCT02483559|Other|Placebo Lenses|Glasses fitted with placebo lenses that allow all visible spectrum of light to be worn prior to desired sleep onset time.
16055874|NCT02483546|Device|Laerdal®|simulation- based educational intervention
16055875|NCT02483546|Behavioral|huma patient based training|Students randomized to receive simulation training .The mannequin Siman 3G laerdal® displays multiple physiologic and pharmacologic responses. Three volunteers were involved in the scenario while the others were observers through an audiovisual projection. Students participating in the scenario were given 15 minutes to evaluate and manage a 60-year-old man with a known history of coronary artery disease and diabetes who presented to the emergency department with chest pain revealing an acute ST elevation myocardial infarction complicated by ventricular fibrillation. Students were required to recognize and manage ventricular fibrillation when the patient became pulseless and unresponsive. After performing the simulation, the entire group was convened for debriefing of the case.
16055876|NCT02483546|Behavioral|traditionally teaching|Control group students received a traditional course using slides during 60 minutes about the management of cardio pulmonary resuscitation according to the latest recommendations of the AHA. This course is offered by the same trainer who participated in the simulation session. Students were free to ask questions as the progress of education. The same educational objectives were treated with the two groups.
16055877|NCT02483533|Drug|LIPO-202|
16055878|NCT02483533|Drug|Placebo|
16055879|NCT02483520|Behavioral|FamTechCare|Caregiver submitted videos of challenging care situations are uploaded to a HIPAA secure site and reviewed by dementia care experts who provide feedback for improving care.
16055880|NCT02483507|Other|Ultrasound-guided approach to peripheral vascular access|the transversal approach is in short axis with an out of plane puncture, the longitudinal approach is in transversal axis with an in plane puncture, the oblique view approach is in obliques axis with an in plane puncture
16055881|NCT02483494|Other|APN-led Telemedicine|"Allocation to experimental or Usual care is 1:1.
~The four study APNs will be delivering the care and have at least three years working experiences in coronary care settings. A telephonic script and study protocol is made available to ensure standardization of intervention."
16055882|NCT02483481|Procedure|shear wave ultrasound elastography|
16055883|NCT02483468|Behavioral|Cognitive Behavioral Therapy for Pain|Cognitive-behavioral therapy (CBT) for pain management takes an active problem-solving approach to tackling the many challenges associated with the experience of chronic pain. Rather than seeing ones self as helpless and disabled because of pain, CBT encourages individuals to take back control and re-engage in activities.
16055884|NCT02483468|Device|Transcranial Direct Current Stimulation|Electrical stimulation of the prefrontal cortex using 2mA of direct current
16055885|NCT02483468|Device|Sham Transcranial Direct Current Stimulation|Sham stimulation of the left dorsolateral prefrontal cortex
16055886|NCT02483455|Drug|2014-ALC-919-US|A topical solution to be applied twice daily for the treatment of Common Warts
16055887|NCT02483455|Drug|Vehicle-Control Topical Solution|A topical solution to be applied twice daily for the treatment of Common Warts
16055888|NCT02483429|Device|VRT Care|The VOG report includes direct device output (physiologic traces, quantitative measures) plus most likely diagnosis, category, and clinical trial care pathway (peripheral, equivocal, central) instructions. The VOG report becomes part of the patient's emergency department clinical record.
16055889|NCT02483403|Other|Hyperpolarized Helium-3|Hyperpolarized noble gas imaging using Helium-3 has been used to explore structural and functional relationships in the lung in patients with lung disease and healthy controls. In contrast to proton-based MRI imaging, Helium-3 gas is used as a contrast agent to directly visualize the airways, and thus ventilation. Whereas the normal density of gas is too low to produce an easily detectable signal, this is overcome by artificially increasing the amount of polarization per unit volume using optical pumping.
16055890|NCT02483403|Device|MRI|
16055891|NCT02483390|Other|psychosocial intervention|e-health services (e.g. by use of SKYPE) to the psychosocial needs of patients and their families who are getting services through home hospice care. In addition, the attitudes of the hospice staff will be investigated to the use of e-health methods.
16055892|NCT02483377|Other|Quality-of-Life Assessment|Ancillary studies
16055893|NCT02483377|Other|Questionnaire Administration|Complete questionnaires
16055894|NCT02483364|Other|HC-SVT-1001(initial protocol); HC-SVT-1002 (protocol amendment)|A single application in the context of a single surgical intervention.
16055895|NCT02483351|Other|Liberal Red Blood Cell Transfusion Strategy|RBC Transfusion strategy with hemoglobin trigger of 100g/L
16055896|NCT02483351|Other|Restrictive Red Blood Cell Transfusion Strategy|Optional RBC Transfusion with hemoglobin trigger of <=80g/L
16055897|NCT02483338|Behavioral|Assessment of pain|Assessment of pain using FASS but without using this score to manage pain
16055898|NCT02483325|Drug|Allogeneic transplant conditioning|Allogeneic transplant
16055899|NCT02483312|Biological|IL-12|
16055900|NCT02483299|Drug|Metformin|
16055901|NCT02483299|Drug|Glucophage tablets and Victoza|
16055902|NCT02483286|Behavioral|ICG|"Core 2-hour education course including practice of study home exercise program. Weekly professional led exercise program for 90 mins at NTUHBB site with reinforcement on osteoporosis related educations and care managements from study educational booklet and CD-rom for 3-month.
~The exercise program included 15 minutes warm up with 10 minute brisk walks followed by gentle stretching. Resistance training (20-30 minutes) was provided with rubber band and bottled water (0.6-1L) as weight for major muscles of upper and lower limbs. Balance training were also provided for 10 minutes with tandem gaits and one leg standing, step up and down stairs, toe walking and heel walking.
~Subjects are encouraged to practice study home exercise program at least twice weekly."
16055903|NCT02483286|Behavioral|MTG|MTG group subjects were invited to NTUHBB site to receive 2 sessions of 45-minute training using isotonic strength training machines on major muscle groups each week. The intensity is set at 60-80% of 1 repetition maximum (RM). Evaluation of the exercise protocol are repeated every 2 weeks for individualized adjustments by trained physical therapist
16055904|NCT02483286|Behavioral|XBG|XBG group subjects were invited to LCGMH site to receive 2 sessions of 45-minute training using x-box machine with combination programs selected from existing commercial programs with a exercise training specialist.
16055905|NCT02483260|Drug|Ribavirin|"Loading dose, 33 mg/kg (maximum dose: 2.64 g)
~Followed in 6 hours by a dose of 16 mg/kg (maximum dose: 1.28 g) every 6 hours for the first 4 days (15 doses)
~Followed by a dose of 8 mg/kg (maximum dose: 0.64 g) every 8 hours for the subsequent 6 days (18 doses)."
16055906|NCT02483247|Drug|BBI503|Patients in this trial will receive BBI503 orally, daily, and continuously. The dose-level of BBI503 will be assigned according to the dose-cohort open at the time the patient enrolls into a given arm. The study-arm and combination anti-cancer agent for a given patient will be determined by the investigator. BBI503 Dose Level 1: 200 mg once daily, Dose Level 2: 300 mg once daily.
16055907|NCT02483247|Drug|Capecitabine|Capecitabine 1000 mg/m^2 body surface area is administered orally, twice daily, on days 1-14 of each 21 day cycle.
16055908|NCT02483247|Drug|Doxorubicin|Doxorubicin 60 mg/m^2 body surface area is administered intravenously once every three weeks (21-days).
16055909|NCT02483247|Drug|Nivolumab|Nivolumab 3 mg/kg is administered as an intravenous infusion over 60 minutes on day 1 and day 15 of each 28 day cycle.
16055910|NCT02483247|Drug|Pembrolizumab|Pembrolizumab 2 mg/kg is administered as an intravenous infusion over 30 minutes once every three weeks (21-days).
16055911|NCT02483247|Drug|Paclitaxel|Paclitaxel 80 mg/m^2 body surface area is administered intravenously once weekly on day 1, day 8, and day 15 of each 28 day cycle.
16055912|NCT02483247|Drug|Sunitinib|Sunitinib 37.5 mg is administered once daily.
16055913|NCT02483234|Drug|secukinumab|
16055914|NCT02483221|Drug|Hydromorphone|Hydromorphone is given intravenously by TCI-PCA. The TCI-PCA system steer the hydromorphone infusion pump to achieve plasma and effect-site concentrations of hydromorphone in predefined increasing steps on patient request and in predefined decreasing steps on lack of patient request within predefined plasma and effect-site concentration range, lockout times and infusion speed.
16055915|NCT02483221|Drug|Morphine|Morphine is given intravenously by PCA. The PCA pump administers a predefined bolus dose on patient request considering the predefined lockout time and infusion speed.
16055916|NCT02483208|Drug|BAY81-8973|BAY81-8973 infusion to analyze pharmacokinetics
16055917|NCT02483208|Drug|Advate|Advate infusion to analyze pharmacokinetics.
16055918|NCT02483195|Drug|5% Minoxidil|This will be a mixed combination of 5% Minoxidil and 200mg Spironolactone to be used once daily.
16055919|NCT02483195|Drug|200mg Spironolactone|This will be a mixed combination of 5% Minoxidil and 200mg Spironolactone to be used once daily.
16055920|NCT02483195|Drug|5mg Finasteride|This will be a mixed combination of 5mg Finasteride with placebo topical preparation to be used once daily.
16055921|NCT02483195|Other|Placebo|This will be a mixed combination of 5mg Finasteride with placebo topical preparation to be used once daily.
16055922|NCT02483182|Drug|ZEP-3 ointment 1.0%|
16055923|NCT02483182|Drug|Acyclovir cream 5%|
16055924|NCT02483169|Drug|cilostazol|Cilostazol 100mg bid
16055925|NCT02483169|Drug|Probucol|Probucol 250mg bid
16055926|NCT02483169|Drug|Aspirin|Aspirin 100mg qd
16055927|NCT02483169|Drug|placebo of cilostazol|same shape and size of active cilostazol
16055928|NCT02483169|Drug|Placebo of aspirin|same size and shape of active aspirin 100mg
16055929|NCT02483169|Device|Intima-medial thickness|ultrasound measured IMT of both common carotid arteries
16055930|NCT02483156|Drug|Two tablets of EHCV in Single Dose each tablet containing SOF 200 mg, RBV 500 mg and Natural anti-hemolytic (AH) at 200 mg|The fixed dose EHCV combinations in Single Dose (2 tablets) once daily each tablet containing SOF 200 mg, RBV 500 mg, and Natural anti-hemolytic (AH) at 200 mg. Subjects will take 2 tablet with food for 12-24 weeks.
16055931|NCT02483156|Drug|Sofosbuvir tablet (SOF) 400 mg - once daily|SOF is manufactured as a 400 mg tablet for oral administration. Subjects will take 1 tablet for a total dose of 400 mg orally once daily in the morning with RBV and with food for 12-24 weeks.
16055932|NCT02483156|Drug|Ribavirin (RBV) 1000 mg - splitted on 2 doses daily - 600 mg on morning and 400 mg on evening|RBV (1000 mg.) splitted on 2 doses daily - 600 mg on morning and 400 mg on evening with SOF and with food for 12-24 weeks.
16055933|NCT02483143|Drug|NAC|3 gr NAC was made up to 1000 ml with NS; a 1 ml/3 mgr NAC solution was obtained and 3 ml/kg NAC+NS solution was administered for 1 h before CTPA and a 1 ml/kg per hour NAC+NS solution was administered for a minimum 6 h after CTPA.
16055934|NCT02483143|Drug|NaHCO3|132 mEq NaHCO3 was made up to 1000 ml with NS; and 3 ml/kg NaHCO3+NS solution was administered for 1 h before CTPA and 1 ml/kg per hour NaHCO3+NS solution was administered for a minimum of 6 h after CTPA.
16055935|NCT02483143|Drug|Normal Saline|3 ml/kg NS was administered for 1 h before CTPA and 1 ml/kg per hour was administered for a minimum of 6 h after CTPA.
16055936|NCT02483130|Dietary Supplement|N-Acetylcysteine|Participants will receive 2400mg of N-Acetylcysteine orally via 6 x 400mg capsules.
16055937|NCT02483130|Other|Placebo|Participants will receive 2400mg of placebo orally via 6 x 400mg capsules.
16055938|NCT02483117|Other|Adaptation of the CIA|Adaptation of the CIA into Spanish was performed using the backward-forward translation process, which ensures conceptual. Forward translation into Spanish was carried out by two independent native Spanish speaking translators who were fluent in English. Two other independent translators, totally blind to the original version, whose native language was English and who were fluent in Spanish, back-translated the consensus version into English. After reaching consensus on a final translated version, it was sent to the CIA's original author (Dr. Bohn) who gave her approval. We undertook a cognitive debriefing process with a group of 5 ED patients to identify any problems with language. The pre-final version was administered to two small groups, one made up of patients (a sample of 5 respondents) and the other of clinical experts (2 psychiatrists and 2 psychologists who were experts on ED).
16055939|NCT02483104|Drug|veliparib|Veliparib will be given orally, twice daily on Days 1-21, every 21 days.
16055940|NCT02483104|Drug|carboplatin|Carboplatin will be administered on Day 1 of each cycle, intravenously.
16055941|NCT02483104|Drug|paclitaxel|Paclitaxel will be administered on Days 1, 8, 15 of each cycle, intravenously.
16055986|NCT02482792|Other|Norwegian Psychomotor Physiotherapy|The recruited patients will after randomization receive either Norwegian Psychomotor Physiotherapy (NPMP) or COPE combined with active individual physiotherapy. In NPMP the treatment is individualized, targeting body-mind awareness through exercise, massage and therapeutic conversation
16056071|NCT02482129|Drug|LME636 Vehicle|Inactive ingredients used for masking purposes
16055942|NCT02483091|Behavioral|Multifaceted KT intervention|"The intervention consists of three webinars followed by the quiz, two online case scenario and a video on BAP model plus a printed copy of Clinical Practice Guideline (CPGs) on NSNP.
~After completing these modules and learning the key strategies, each chiropractor will recruit five neck pain patients and implement the strategies on their patients to measure the clinical outcomes for a follow-up of three months.
~The control group will receive only a printed copy of CPGs. A checklist of proxy measures embedded within patient encounter forms will be used to assess chiropractors' compliance with guideline recommendations at study onset and at three months."
16055943|NCT02483078|Drug|PRO 140|PRO 140 is a humanized IgG4,κ monoclonal antibody (mAb) to the chemokine receptor CCR5.
16055944|NCT02483078|Drug|Placebo|
16055945|NCT02483078|Drug|Optimized Background Regimen|Optimized background therapy (OBT) is chosen on the basis of a subject's resistance test results and treatment history.
16055946|NCT02483065|Other|mortality at discharge and 3-months after the admission in patients with and without dementia|Patients diagnosed of dementia who ingresed the hospital were informed of the goals of the study and invited to voluntarily participate. In order to take part in the study, patients were required to provide informed consent. All participants were first screened with the Alzheimer's Disease Test. A diagnosis of dementia was generated by an independent clinician experienced in old age psychiatry using a structured clinical assessment based on operationalized DSM-IV criteria. Clinical data were gathered from hospital notes. Information on sociodemographic data, premorbid basic and instrumental activities of daily living, quality of life and burden of the caregiver was gathered from carers and review of hospital notes. In both cohorts, participants were telephoned 3 months after hospital admission to respond the follow-up questionnaires. Patients who decided not to answer them were considered lost to follow-up. All information was kept confidential.
16055947|NCT02483052|Device|RejuvenAir|RejuvenAir
16055948|NCT02483039|Behavioral|AKI Follow-up Clinic|Participants randomized to this arm will be referred to the AKI Follow-up Clinic where they will see a nephrologist who will coordinate follow-up care. At the AKI Follow-up Clinic, assessment forms that were developed during the pilot study at St. Michael's Hospital may be used, but this decision will be left to individual sites. Routine laboratory investigations will be performed at minimum every three months.
16055949|NCT02483026|Dietary Supplement|Multi vitamin|Multi vitamin
16055950|NCT02483026|Dietary Supplement|vitamin D|Vitamin D
16055951|NCT02483013|Other|whitening dentifrices|Two groups: participants received the instructions to use only the blinded supplied whitening dentifrice (Colgate Luminous White® or Close up White Now®) and toothbrush to make the habitual oral hygiene, three times per day during four weeks
16055952|NCT02483013|Other|Placebo|One group: participants received the instructions to use only the blinded supplied non-whitening dentifrice (Sorriso®) and toothbrush to make the habitual oral hygiene, three times per day during four weeks
16055953|NCT02483000|Biological|Anti-CD20 B9E9 scFv-Streptavidin Fusion Protein|Given IV
16055954|NCT02483000|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo autologous PBSCT
16055955|NCT02483000|Drug|Carmustine|Given IV
16055956|NCT02483000|Drug|Clearing Agent|Given IV
16055957|NCT02483000|Drug|Cytarabine|Given IV
16055958|NCT02483000|Drug|Etoposide|Given IV
16055959|NCT02483000|Radiation|Indium In 111-DOTA-Biotin|Given IV
16055960|NCT02483000|Other|Laboratory Biomarker Analysis|Correlative studies
16055961|NCT02483000|Drug|Melphalan|Given IV
16055962|NCT02483000|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo autologous PBSCT
16055963|NCT02483000|Other|Pharmacological Study|Correlative studies
16055964|NCT02483000|Radiation|Yttrium Y 90-DOTA-Biotin|Given IV
16055965|NCT02482987|Device|dense polytetrafluoroethylene (dPTFE) membrane Cytoplast|ridge preservation intervention using the dPTFE membrane device
16055966|NCT02482987|Device|human amniotic-tissue derived membrane BioXclude|ridge preservation intervention using the dPTFE membrane device
16055967|NCT02482987|Procedure|Ridge Preservation with overlay graft|ridge preservation intervention with additional freeze dried bone allograft (FDBA) placed buccal to the socket
16055968|NCT02482987|Procedure|Ridge Preservation without overlay graft|ridge preservation without overlay graft / traditional FDBA placement into the socket only
16055969|NCT02482961|Drug|colistimethate sodium|At least once a week, all patients with carbapenem-resistant Acinetobacter baumannii infection were screened from the database at the clinical microbiology laboratory
16055970|NCT02482948|Device|Active Leptospermum Honey (Medihoney)|STudy agent to be applied to the wound daily.
16055971|NCT02482948|Drug|Collagenase|Study agent to be applied daily to the wound.
16055972|NCT02482935|Drug|Abemaciclib|Administered orally
16055973|NCT02482922|Other|Exercise & Dietary Supplement|
16055974|NCT02482909|Procedure|Hepatic resection|Anatomical surgical resection of the liver including the tumor
16055975|NCT02482909|Procedure|Radiofrequency ablation|Percutaneous ablation using radiofrequency under the imaging guidance
16055976|NCT02482883|Device|Transcutaneous Electrical Nerve Stimulation (TENS)|All patients will undergo placement of a facial transcutaneous electrical nervous stimulation (TENS) device, but device activation will be randomized [active stimulation vs non-active (placebo) stimulation], for an initial period of 10 days.
16055977|NCT02482870|Device|Macintosh laryngoscope|Using a Macintosh laryngoscope, time to glottic view, best Cormack-Lehane grade, time to intubation, time to first ventilation has been recorded.
16055978|NCT02482870|Device|King Vision video laryngoscope|Using a King Vision video laryngoscope, time to glottic view, best Cormack-Lehane grade, time to intubation, time to first ventilation has been recorded.
16055979|NCT02482857|Drug|Acetylsalicylic acid|To compare BID dosing with OD dosing with clinically used aspirin dosages.
16055980|NCT02482844|Other|pacemaker implantation|
16055981|NCT02482844|Other|holter implantation|
16055982|NCT02482831|Procedure|Subgluteal sciatic nerve block|All patients (either diabetic or non-diabetic patients) received an ultrasound-guided (nerve stimulator assisted) subgluteal sciatic nerve block with 0.75% ropivacaine 20ml.
16055983|NCT02482818|Drug|Pregabalin|Increasing dose regimen depending on tolerability followed by decreasing dose regimen.
16055984|NCT02482818|Drug|Control-Placebo|A control substance, Lactose is administered in place of Pregabalin.
16055987|NCT02482792|Other|Cognitive Patient Education and PT|The comparison group will receive a combination of education about how to manage pain (COPE) followed by active individual physiotherapy.
16055988|NCT02482766|Drug|Poractant alfa, 200 mg/kg|Endotracheal Surfactant administration
16055989|NCT02482766|Device|Ventilator for High-frequency Oscillatory Ventilation (HFOV)|This device will be used to perform an HFOV recruitment maneuver before surfactant administration
16055990|NCT02482766|Device|Nasal Continuous Positive Airway Pressure (nCPAP)|After surfactant administration, the babies will be extubated within 30 minutes and will receive nCPAP (6-8 cm H2O)
16055991|NCT02482753|Drug|Chidamide|30 mg, administered orally twice per week (BIW)
16055992|NCT02482753|Drug|exemestane|25 mg, PO daily
16055993|NCT02482753|Drug|placebo|Administered orally twice per week (BIW)
16055994|NCT02482740|Drug|Letrozole|letrozole 2.5 mg qd was given for 12 months or till disease progress
16055995|NCT02482740|Drug|tamoxifen|tamoxifen was given 20 mg qd for 12 months or till disease progress
16055996|NCT02482727|Device|occlusion training with tourniquet (DELFI PTS ii portable tourniquet system)|A cuff will be wrapped around the most proximal portion of the arm of the involved extremity. In order to individualize the pressure for each subject, the limb occlusion pressure will be measured (with dopplar ultrasound over the radial artery at the wrist level) at the first scheduled therapy visit. The cuff pressure utilized during the post-operative exercises will be set at 50% of the limb occlusion pressure. The subjects' strength will be re-assessed approximately every 2-4 weeks and the load will be increased as tolerated.
16055997|NCT02482714|Behavioral|Physical activity.|Have subject do moderate physical activity.
16055998|NCT02482701|Device|Captivator™ EMR|The Captivator ™ EMR Device is indicated for endoscopic mucosal resection (EMR) in the upper gastrointestinal (GI) tract.
16055999|NCT02482688|Behavioral|A New Rehabilitation Treatment following Stroke|A randomised control design, comparing individuals who will receive visual unisensory stimulation alone (i.e., the control rehabilitation) and those who receive multisensory stimulation (i.e., the experimental rehabilitation), will be used to assess the effects of multisensory rehabilitation on learning, performance accuracy and speed in participants with neglect/extinction.
16056000|NCT02482675|Other|Glucose|Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.
16056001|NCT02482675|Other|Glucose with Non-fat Milk|Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.
16056002|NCT02482675|Other|Glucose with Whey Protein Isolate|Following baseline measurements, participants will consume 75 g glucose and whey protein isolate dissolved in 2 cups water within five minutes.
16056003|NCT02482675|Other|Glucose with Sodium Caseinate|Following baseline measurements, participants will consume 75 g glucose and sodium caseinate dissolved in 2 cups water within five minutes.
16056004|NCT02482662|Procedure|Diagnosis|Oral glucose tolerance test and self-monitoring blood glucose
16056005|NCT02482649|Behavioral|EAA/T|bi-weekly for 12weeks
16056006|NCT02482649|Drug|Methylphenidate|dosage adjustment according to clinical effectiveness, QD for 12weeks
16056007|NCT02482649|Drug|Atomoxetine|dosage adjustment according to clinical effectiveness, QD or BID, for 12weeks
16056008|NCT02482636|Biological|DTaP/IPV/Hib vaccine|Given at 2, 3 and 4 months to Group 1 and 2
16056009|NCT02482636|Biological|13 valent Pneumococcal Conjugate Vaccine|Given at 2,4 and 12 months in group 1, given at 3 and 12 months in group 2
16056010|NCT02482636|Biological|Rotavirus vaccine|Given at 2 and 3 months to Group 1 and 2
16056011|NCT02482636|Biological|4-component Meningococcal B vaccine|Given at 2, 4 and 12 months to Group 1 and 2
16056012|NCT02482636|Biological|Meningococcal C/Hib vaccine (MenC/Hib vaccine)|Given at 12 months to Group1 and 2
16056013|NCT02482636|Biological|Measles/Mumps/Rubella Vaccine (MMR vaccine)|Given at 13 months to Groups 1 and 2
16056014|NCT02482623|Behavioral|Dementia Symptom Management at Home Program|The DSM-H is a multi-modal interprofessional intervention that includes: 1. intensive training of clinician mentors; 2. disseminated online training for Registered Nurses, Physical Therapists, Occupational Therapists; 3. implementation of evidence-based care plans, assessment instruments, and teaching handouts.
16056015|NCT02482610|Other|Glucose|Following baseline measurements, participants will consume a 75 g glucose solution within five minutes.
16056016|NCT02482610|Other|Glucose with Whole Fat Milk|Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of whole fat milk within five minutes.
16056017|NCT02482610|Other|Glucose with Non-fat Milk|Following baseline measurements, participants will consume 75 g glucose dissolved in two cups of non-fat milk within five minutes.
16056018|NCT02482597|Device|Whole Body Periodic Acceleration|A bed that translates back and forth at different frequencies while the subject lies supine
16056019|NCT02482584|Device|CPAP|CPAP intervention
16056020|NCT02482584|Other|Control|Control
16056021|NCT02482571|Device|Mild Hypoxia|During normoxia, the computer-controlled gas blender provides a gas mixture that generates pressures of expired O2 and CO2 similar to the resting values measured for each subject (32-35mmHg and 100-110 mmHg, respectively). During mild hypoxia, we will target the same expired CO2 of normoxia and a 60 mmHg reduction of expired O2 from the resting value (to a minimum limit of 50 mmHg), which is expected to reduce arterial oxygen saturation to 82-85%. In mild hypoxia, the fraction of inspired oxygen is reduced from ~21% (room air) to ~12% (equivalent to an altitude of 4000 meters). During both conditions of normoxia and mild hypoxia, the brain activity of subjects is monitored with functional magnetic resonance spectroscopy (fMRS) while they are presented with visual stimuli.
16056022|NCT02482558|Other|High/Low Glycaemic index test breakfast|High/Low Glycaemic index test breakfast on test days for a High/Low Glycaemic index 7-day diet
16056023|NCT02482545|Dietary Supplement|Meal replacement|
16056024|NCT02482532|Biological|tvs-CTL Vaccine|autologous, 14g2a.zeta chimeric receptor transduced, activated T-cells, enriched for vaccine specific cytotoxic T-lymphocytes (tvs-CTL)
16056025|NCT02482519|Other|High calorie diet|High calorie diet for 10 days
16056026|NCT02482519|Other|Fasting|10 day fast
16056067|NCT02482155|Drug|Ibuprofen|ibuprofen 400 mg single dose oral solution
16056068|NCT02482142|Dietary Supplement|Effect of phosphorus|Ingestion of 500mg of phosphorus ( 4 tablets, each of 125 mg of phosphorus)
16056027|NCT02482506|Behavioral|MF-WLP|The first meeting each week includes a 60-minute class that addresses health knowledge, attitudes, and self-monitoring of weight, food and physical activity; realistic goal setting; stimulus control; problem solving; cognitive restructuring and relapse prevention. Other class activities include weekly weigh-in; increasing awareness of portions by weighing and measuring foods; creating stimulus control plans for home, car and work; identifying barriers to healthy eating and/or exercise; going on a field trip to a local grocery store to practice reading food labels; creating an eating out management plan; and identifying high risk situations and brainstorming ways to manage them. This meeting also includes a 60-minute exercise class. The second meeting each week is a stand-alone 60-minute exercise class that will incorporate a variety of activities. A one-year CPD fitness club membership and home exercise DVDs will be provided.
16056028|NCT02482506|Behavioral|SG-WLP|Control participants will be provided with a 24-week weight loss curriculum; this includes a binder with their personal daily caloric recommendation, all intervention handouts, a copy caloric guidelines and useful weight loss tools. Upon randomization, each control participant will be introduced to the program materials and encouraged to tailor the weight loss program for themselves. The study team will call each control participant once a month during this 6-month program period to check in. In addition, after the follow-up data collection, control participants will receive a one-year membership to the CPD fitness center.
16056029|NCT02482493|Device|Sigma PFC|patients will receive either an all polyethylene tibial component or a metal- backed component
16056030|NCT02482480|Other|Exercise|Walking in community Oropharyngeal exercises Diet recommendations Dietary recommendations Education
16056031|NCT02482480|Other|Control|Dietary and general recommendations
16056032|NCT02482467|Other|Hormonal analysis, pelvic US|
16056033|NCT02482454|Procedure|Radiofrequency ablation|Radiofrequency ablation is performed percutaneously under CT/US guidance
16056034|NCT02482454|Biological|Cytokine-induced killer cells|The patients received autologous cytokine-induced killer cells transfusion one week after RFA treatment.
16056035|NCT02482441|Drug|OMP-131R10|There are 5 planned dose cohorts of OMP-131R10. Dose escalation will follow a traditional 3+3 framework. Treatment will be continued until progressive disease or unacceptable toxicity.
16056036|NCT02482441|Drug|FOLFIRI|Treatment will consist of OMP-131R10 and the FOLFIRI chemotherapy regimen.
16056037|NCT02482428|Drug|Investigational Treatment|Applied twice daily for up to 12 weeks
16056038|NCT02482428|Drug|Aldara|Applied 3 times a week for 16 weeks
16056039|NCT02482415|Other|Psycho-educational|
16056040|NCT02482402|Drug|Inhaled Iloprost|Treatment effect will be controlled at each study visit and the dose and/or inhalation frequency will be adapted.
16056041|NCT02482402|Drug|Placebo|inhalation solution placebo
16056042|NCT02482389|Radiation|Single fraction of 7 Gy|All subjects will receive a single 7 Gy fraction of radiotherapy to the intact tumor prior to surgery.
16056043|NCT02482376|Radiation|Stereotactic body radiotherapy ( SBRT)|Single fraction of 21 Gy stereotactic radiotherapy (SBRT)delivered pre-operatively to subjects with early stage breast cancer
16056044|NCT02482363|Radiation|UVA radiation|20 minutes of low dose UVA from a phototherapy unit
16056045|NCT02482363|Radiation|Sham Control|20 minutes of sham control exposure
16056046|NCT02482350|Behavioral|Reading Training|"Healthy subjects read moving (scrolling) text faster than static text. This type of text, also called Times Square presentation, induces a form of involuntary eye movement called optokinetic nystagmus (OKN) in the reader and, when used as part of a rehabilitation program, has been shown to improve subsequent reading performance of static text."
16056047|NCT02482337|Procedure|POEM|POEM procedure in the OR
16056048|NCT02482324|Drug|ALZT-OP1a|Mast cell stabilizer
16056049|NCT02482324|Drug|ALZT-OP1b|anti-inflammatory
16056050|NCT02482324|Device|Dry Powder Inhaler|The inhaler will be used to deliver ALZT-OP1a via oral inhalation for both days on study.
16056051|NCT02482311|Drug|AZD 1775|"AZD1775 will be taken orally approximately every 12 hours over 3 days at the start of week 1 and week 2 of each 21-day cycle (Days 1-3 and 8-10), for a total of 12 doses with each treatment cycle.
~AZD1775 should be taken approximately 2 hours before or 2 hours after food."
16056052|NCT02482298|Drug|Ticagrelor|Two arms: 1) 10 mg ticagrelor + 45 mg ticagrelor placebo or 2) 45 mg ticagrelor + 10 mg ticagrelor placebo. Drugs taken orally, twice a day (morning and evening, at least 12 hours apart) from randomization until the end of treatment.
16056053|NCT02482298|Drug|Placebo|10 mg ticagrelor placebo + 45 mg ticagrelor placebo. Drugs taken orally, twice a day (morning and evening at least 12 hours apart) from randomization until the end of treatment
16056054|NCT02482272|Drug|Lamivudine|Lamivudine 100mg/day orally
16056055|NCT02482272|Drug|Adefovir|Adefovir 10mg/day orally
16056056|NCT02482272|Drug|Entecavir|Entecavir 1mg/day orally
16056057|NCT02482233|Behavioral|ENDD (NJOY)|As described above.
16056058|NCT02482233|Drug|NRT (NicoDerm CQ)|As described above.
16056059|NCT02482233|Behavioral|telephone counseling|Referral to the California Smokers' Helpline. California Smokers' Helpline will call the patient 4 times, or as agreed upon by the patient.
16056060|NCT02482233|Behavioral|brief advice|"Brief advice lasting less than 2 minutes will be delivered by the research assistant, investigator, or healthcare provider. The advice will be similar to the following statement (customized as needed to the patient): The most important advice I can give you is that quitting smoking is the number one thing you can do for your health and to prepare yourself for surgery. Quitting smoking before surgery may improve your chances of healing quickly. There's evidence that the longer you quit before your surgery, the fewer complications you'll have. I encourage you to make use of the resources that have been provided to you to help you quit and set your quit date for as soon as possible."
16056061|NCT02482233|Behavioral|brochure|"A brochure from the ASA (American Society of Anesthesiologists) about quitting smoking before surgery.
~Available free from the ASA: http://ecommerce.asahq.org/publicationsAndServices/PatientBrochure_%20For%20Posting.pdf"
16056062|NCT02482220|Behavioral|Physical activity intervention|
16056063|NCT02482207|Drug|Rosuvastatin|
16056064|NCT02482207|Behavioral|Life style modification|
16056065|NCT02482194|Biological|mesenchymal stem cells|autologous transplantation of mesenchymal stem cells in spinal cord injury patients
16056066|NCT02482168|Drug|APX005M|APX005M is a CD40 agonistic monoclonal antibody
16056072|NCT02482116|Other|malaria or pneumonia diagnosis|Diagnostic approaches for malaria (lay diagnosis, as per IMCI guidelines by trained primary healthcare workers, clinical diagnosis by medically qualified doctor, rapid diagnostic tests, Giemsa microscopy); Diagnostic approaches for pneumonia (lay diagnosis, as per IMCI guidelines by trained primary healthcare workers, clinical diagnosis by medically qualified doctor, chest x-ray)
16056073|NCT02482103|Procedure|Renal denervation|Catheter based renal nerve ablation
16056074|NCT02482090|Drug|Cyclophosphamide|Cyclophosphamide 60 mg/kg is administered i.v. on day -7 and day -6.
16056075|NCT02482090|Drug|Fludarabine|Fludarabine 25 mg/m2 is administered on day -5 to day -1.
16056076|NCT02482090|Biological|TIL infusion|The maximum number of expanded TILs are infused over 30-45 minutes on day 0.
16056077|NCT02482090|Drug|Interleukin-2|Interleukin-2 is administered as a continous i.v. infusion in a decrescendo regimen (18 MIU/m3 IL-2 over 6 hours, 18 MIU/m2 IL-2 over 12 hours, 18 MIU/m2 IL-2 over 24 hours followed by 4,5 MIU/m2 IL-2 over another 24 hours for three days).
16056078|NCT02482077|Drug|SOF+RBV|Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
16056079|NCT02482077|Drug|SOF+DCV|Sofosbuvir (SOF) 400 mg tablet administered orally once daily. Daclatasvir (DCV) 60mg tablet administered once daily.
16056080|NCT02482077|Drug|LDV/SOF|Ledipasvir 90 mg /Sofosbuvir 400 mg (LDV/SOF) FDC tablet administered orally once daily
16056081|NCT02482064|Other|Flexible resin|This material 'Flexible resin' is going to be used in the construction of the 'flexible obturators'.
16056082|NCT02482038|Device|geko|neuromuscular electrostimulator
16056083|NCT02482025|Other|SMMRT|Includes My HealtheVet registration and enrollment
16056084|NCT02482012|Other|Survey|This was a survey
16056085|NCT02481986|Behavioral|Community Health Worker|A community health worker is para-professional who performs education, case management, and social support.
16056086|NCT02481986|Behavioral|Certified asthma educator|A certified asthma educator has is certified and performs asthma education.
16056087|NCT02481973|Other|Individualised Homoeopathic Remedy|Each participant is to receive an individualised homoeopathic remedy prescribed according to their characteristic symptoms.
16056088|NCT02481960|Procedure|CM-BC2 Irinotecan drug-eluting bead|
16056089|NCT02481947|Drug|BLI400 Laxative|21 gm BLI400 powder
16056090|NCT02481947|Drug|Lubiprostone|24 mcg capsule bid
16056091|NCT02481934|Procedure|NKAE cells infusion|Expanded and activated autologous NK cells infusion. Each patient will receive two infusions of 7.5 x 106 expanded and activated autologous NK cells/kg/cycle.
16056092|NCT02481934|Drug|Lenalidomide|Lenalidomide, 10 mg oral/day during 21 days (cycle). Patients will receive 4 cycles.
16056093|NCT02481934|Drug|Bortezomib|Bortezomib, 1.3 mg/m2, s.c., days 1, 4, 8 and 11/cycle. Patients will receive 4 cycles.
16056094|NCT02481921|Behavioral|Group medical visits|Or shared medical appointments where a multidisciplinary team of providers with expertise in nutrition, nursing, behavior and medication management join to manage heart failure in addition to and in support of, the patient's regular physician visits.
16056095|NCT02481908|Device|STI measurements at baseline and under Valsalva maneuver|STI measurements at baseline and under Valsalva maneuver
16056096|NCT02481895|Behavioral|E-neurocognitive module|The experimental group will take part of a 12-week extension with a total of 36 hours training with the e-neurocognitive module tailored for bipolar patients
16056097|NCT02481882|Device|Magnetic Resonance Imaging|All scanning will be performed using a 7 Tesla Philips Achieva scanner with multi-transit capability (Philips Medical Systems, Best, The Netherlands). The volunteers will be scanned with a 32-channel receive coil.
16056098|NCT02481882|Drug|Prohance (Gadoteridol)|A gadolinium based liquid administered intravenously in order to quantify blood flow in the brain using an MR scanner.
16056099|NCT02481869|Biological|Arthrocentesis/PRP|PRP (n=20): single intra-articular injection of 5 ml of a leukocyte-reduced platelet rich plasma (ACP, Arthrex, Naples, FL) at the time of closed reduction and initial stabilization using ankle-spanning external fixation
16056100|NCT02481869|Drug|Arthrocentesis/Saline|Control (n=20): single intra-articular injection of 5 ml of sterile 0.9% saline at the time of closed reduction and initial stabilization using ankle-spanning external fixation
16056101|NCT02481856|Drug|SQ tree SLIT-tablet|
16056102|NCT02481856|Drug|Placebo|
16056103|NCT02481843|Other|2 hours of hyperoxia (FiO2 = 1)|Patients received 2 hours of hyperoxia at FiO2 = 1
16056104|NCT02481830|Drug|Nivolumab|
16056105|NCT02481830|Drug|Topotecan|
16056106|NCT02481830|Drug|Amrubicin|
16056110|NCT02481804|Other|Dietary intervention|"Patients will be counseled by a dietician for 14 weeks. A tailored diet advice for each NET patient will be based on the individual situation which includes gastrointestinal complaints, the location of the tumor, additional treatments like previous surgery and measured vitamine and tryptophan levels.
~Dietician consults will be conducted by 1 out-patient visit and 3 follow up contacts."
16056111|NCT02481804|Other|Standard treatment|Standard treatment will be continued
16056112|NCT02481791|Drug|Remifentanil and/or propofol|Induction Phase: A dose of remifentanil 1mcg/kg by slow bolus, will be given to facilitate endotracheal intubation. Further doses of either remifentanil (0.5 mcg/kg) or propofol (1-2mg/kg) may be given to ensure an anaesthetised patient.
16056113|NCT02481791|Drug|Remifentanil and/or propofol|Settling Period: An infusion of the test dose of remifentanil will be commenced from an infusion prepared prior to the patient being anaesthetised. 1mg of Remifentanil (one vial) will be diluted to a volume of 50mls in normal saline 0.9% in a 50ml syringe. Maintenance dose of propofol 130 mcg/Kg/min for the first 5 minutes reduced to 100 mcg/kg/min thereafter. 40mls of propofol 1% (10mg/ml) will be drawn undiluted into a 50ml syringe. During the settling period further doses of either remifentanil (0.5 mcg/kg) or propofol (1-2mg/kg) may be given.
16056189|NCT02481310|Biological|Rituximab|Given IV
16056114|NCT02481791|Drug|propofol|Equilibrium Period: During this period propofol will be infused at a constant rate of 100mcg/kg/min
16056115|NCT02481778|Other|Blood sampling|
16056116|NCT02481765|Device|High definition transcranial direct current stimulation|
16056117|NCT02481752|Other|Approach Avoidance Training|The Approach Avoidance Task (AAT) used for this experiment is an implicit, computerized paradigm in which participants respond to visually presented pictures on a computer screen displaying either 1) smoking-related images or 2) positive images, by pulling a joystick either towards their body (approach movement) or pushing it away from their body (avoidance movement). By pulling the joystick towards their body, the picture grows in size; by pushing the joystick away, the picture shrinks and then disappears from the screen. Participants are instructed to pull upon seeing an image tilted to the right and to push upon seeing a left-tilt image, while ignoring the image content and responding as quickly and as accurately as possible.
16056118|NCT02481752|Other|SHAM Training|
16056119|NCT02481739|Other|retrospective study|
16056120|NCT02481726|Radiation|68Ga-labeled peptides of dimer RGD (Alfatide II) and 18F-FDG|
16056121|NCT02481713|Behavioral|motivational interviewing|motivational interviewing
16056122|NCT02481713|Behavioral|learning style interviews|interview and feedback about learning style
16056123|NCT02481700|Procedure|Third molar removal|The surgical removal of third molars
16056124|NCT02481687|Other|Confocal laser endomicroscopy|Probe based confocal laser endomicroscopy is a contrast based technique, consisting of a flexible catheter probe representing a bundle of optical fibers linked to a micro-objective a laser scanning unit and the control and acquisition software. The flexible confocal miniprobes can be passed through the working channels of standard endoscopes. The principle of the technique is based on a laser beam of defined wavelength being focused towards the targeted tissue and the recaptured signal is displayed as 'optical biopsies' in a single horizontal plane. The device was intended to be used for faster diagnosis and evaluation of gut diseases, by allowin in vivo histology.
16056125|NCT02481674|Drug|VX15/2503|VX15/2503 is a humanized IgG4 monoclonal antibody and will be administered intravenously at a dose of 20 mg/kg. The antibody is formulated at 20 mg/mL in 20 mM Sodium Acetate buffer, pH 5.4, containing 130 mM Sodium Chloride and 0.02% Polysorbate 80.
16056126|NCT02481674|Drug|Placebo|Placebo consists of formulation buffer only which is 20 mM Sodium Acetate buffer, pH 5.4, containing 130 mM Sodium Chloride and 0.02% Polysorbate 80.
16056127|NCT02481661|Procedure|segmentectomy|segmentectomy in Arm I and lobectomy in Arm II
16056128|NCT02481648|Other|Exercise|
16056129|NCT02481635|Drug|Gemcitabine|
16056130|NCT02481635|Drug|Nab-paclitaxel|
16056131|NCT02481635|Radiation|Radiation Therapy|
16056132|NCT02481635|Procedure|Surgical Resection|
16056133|NCT02481609|Drug|N-acetyl cysteine (NAC)|
16056134|NCT02481596|Behavioral|REACH + FAMS|The intervention consists of REACH individual-focused text messaging, plus family-focused phone coaching sessions, goal-focused text messaging, and the option to invite a family member/support person to receive text messages.
16056135|NCT02481596|Behavioral|REACH|The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, plus text messaging targeting other self-care behaviors (see NCT02409329).
16056136|NCT02481596|Behavioral|Helpline & A1c results|Participants complete all study assessments, receive text messages advising how to access study A1c results, and have access to a helpline for study- or diabetes medication-related questions.
16056137|NCT02481583|Drug|Levosulpiride|different formulations of levosulpiride
16056138|NCT02481570|Other|pharmacokinetic simulation|The aim of the simulation is to recommend dosing adjustments to improve postoperative analgesia with a rapid emergence.
16056139|NCT02481557|Device|Oxalate Salt Solution|Applied by dentist
16056140|NCT02481544|Behavioral|Gratitude Journaling Plus SOC|
16056141|NCT02481544|Behavioral|Memorable Events Journaling Plus SOC|
16056142|NCT02481531|Other|Previously marketed infant formula|
16056143|NCT02481531|Other|Previously marketed formula using a similar protein|
16056144|NCT02481518|Drug|Magnesium|Pre loading fluid with Magnesium sulphate 16 milliequivalent plus potassium chloride 20 milliequivalent in Normal saline 500 ml IV drip in 4 hours before Cisplatin administration
16056145|NCT02481518|Other|Control|Potassium chloride 20 milliequivalent in Normal saline 500 ml IV drip in 4 hours before Cisplatin administration
16056146|NCT02481505|Drug|Chloroprocaine HCl 1%|Intrathecal Route
16056147|NCT02481492|Device|No flip technique of Shang Ring circumcision|Measure the diameter of the penis with a scale plate of holes, the diameter of the ring was accordance with the glands, inner ring is placed into foreskin cavity, apply the outer ring on the skin covering inner ring, clamp the out ring and cut the redundant foreskin; Ring is detached spontaneously.
16056148|NCT02481492|Device|Flip technique of Shang Ring circumcision|Measure the diameter of the penis with a scale plate of holes, the diameter of the ring was accordance with the penis, inner ring is placed around the penis, flip foreskin over the inner ring, apply the outer ring on the skin covering inner ring, clamp the out ring and cut the redundant foreskin; Remove the ring 7days postoperatively.
16056149|NCT02481479|Drug|Saxagliptin|Eligible patients will undergo baseline CMR, commence treatment and then after 6 months undergo repeat CMR
16056150|NCT02481479|Drug|Saxagliptin|Eligible patients will undergo baseline echocardiogram, commence treatment and then after 6 months undergo repeat echocardiogram
16056151|NCT02481479|Drug|saxagliptin|Eligible patients will undergo baseline venipuncture, commence treatment and then after 6 months undergo repeat venipuncture
16056177|NCT02481336|Procedure|Peripheral nervous system examination|nerve conduction velocity (NCV), quantitative sensory test (QST), and nerve excitability test (NET)
16056178|NCT02481336|Genetic|Whole Genome Sequence|Genetic Test : 10 mL blood will be collected in Blood Sample Collection
16056179|NCT02481323|Drug|isosorbide mononitrate|slow release nitric oxide donor that enhances vasodilation and widely used in angina prophyaxis
16056180|NCT02481323|Drug|cilostazol|phosphodiesterase 3-inhibitor that enhances vessel wall function with weak antiplatelet effects
16056181|NCT02481310|Drug|Cyclophosphamide|Given IV
16056182|NCT02481310|Drug|Cytarabine|Given IT or intraventricularly
16056183|NCT02481310|Drug|Doxorubicin Hydrochloride|Given IV
16056184|NCT02481310|Drug|Etoposide|Given IV
16056152|NCT02481466|Behavioral|Portfolio diet and structured exercise|"Diet: Foods will contribute 9 g/1000 kcal viscous fibre as β-glucan (oats, barley and oat bran breads) and psyllium (cereal), 1 g plant sterol/1000 kcal diet (in sterol margarine), 22.5 g soy protein/1000 kcal (soy burgers and other soy meat analogues, soy milks, yogurts and cheese) and 22.5 g nuts/1000 kcal and increased MUFA (as olive and canola oils, avocados, nuts etc.). The glycemic index will be reduced from 83 to 70 GI units (bread scale).
~Exercise: A program encouraging 150 minutes of exercise, based on the Quebec Heart and Lung Institute exercise program. A short submaximal treadmill test will be used to assess cardiorespiratory fitness. A kinesiologist will work with participants using behavioral strategies to achieve the target of 150 min/week of physical activity or exercise in 3 or 5 sessions weekly (vigorous, moderate or mild depending on goals and tolerance). The target goal will be at least 10,000 steps daily."
16056153|NCT02481466|Behavioral|DASH-like diet and structured exercise|"Diet: Participants will be encouraged to follow a diet of whole grain foods (brown rice, whole wheat breads, muffins and breakfast cereals), reduce meat consumption, choose low fat dairy foods and a control margarine.
~Exercise: A physical activity/exercise program encouraging 150 minutes of exercise, based on the exercise program developed at the Quebec Heart and Lung Institute. A short submaximal treadmill test will be used to assess cardiorespiratory fitness. A kinesiologist will work with participants using behavioral strategies to develop and support a plan that aims to achieve the target of 150 min/week of physical activity or exercise in 3 or 5 sessions weekly (vigorous, moderate or mild depending of goals and tolerance) in keeping with maximum achievable goals of participants. The target goal will be at least 10,000 steps daily recorded on their pedometers."
16056154|NCT02481466|Behavioral|Portfolio diet and routine exercise|"Diet: Foods on the dietary portfolio plan will contribute 9 g/1000 kcal viscous fibre as β-glucan (oats, barley and oat bran breads) and psyllium (cereal), 1 g plant sterol/1000 kcal diet (in sterol margarine), 22.5 g soy protein/1000 kcal (soy burgers and other soy meat analogues, soy milks, yogurts and cheese) and 22.5 g peanuts or equivalent of tree nuts/1000 kcal (Table 1A) and increased MUFA (as olive and canola oils, avocados, nuts etc.). The glycemic index will be reduced from 83 to 70 GI units (bread scale).
~Exercise: Participants in this group will receive standard of care for individuals being seen by a general practitioner. They will be advised to achieve the current recommended targets for daily physical activity and educational material published by Health Canada (Canada's Physical Activity Guide, Health Canada). They will undergo treadmill tests at the start and end of each 1 year period. They will not receive the more frequent, targeted visits with a kinesiologist."
16056155|NCT02481466|Behavioral|DASH-like diet and routine exercise|"Diet: Participants will be encouraged to follow a diet of whole grain foods (brown rice, whole wheat breads, muffins and breakfast cereals), reduce meat consumption, choose low fat dairy foods and a control margarine.
~Exercise: Participants in this group will receive standard of care for individuals being seen by a general practitioner. They will be advised to achieve the current recommended targets for daily physical activity and educational material published by Health Canada (Canada's Physical Activity Guide, Health Canada). They will undergo treadmill tests at the start and end of each 1 year period. They will not receive the more frequent, targeted visits with a kinesiologist."
16056156|NCT02481453|Drug|Rapamycin|Experimental: rapamycin oral solution, 2 mg/day during one year Comparator: placebo
16056157|NCT02481453|Drug|Placebo|Comparator: placebo
16056158|NCT02481440|Biological|human umbilical cord mesenchymal stem cells (hUC-MSCs)|Four times of intrathecal administrations of hUC-MSCs
16056159|NCT02481427|Procedure|Unicondylar Knee Replacement|UKA involves only the replacement of affected medial compartment. In the study, the operation will be performed through standard medial parapatellar incision with midline skin incision, but the knee joint and fascia will be opened like in standard Oxford minimally invasive incision. The procedure will be performed by using Oxford Microplasty instrumentation and following Microplasty surgical technique (Biomet Orthopedics). Intraoperative local infiltration analgesia is used for postoperative pain management. Drain is not used.
16056160|NCT02481427|Procedure|Total Knee Replacement|TKA is performed through a standard medial parapatellar incision, which provides easy access to the knee joint. Skin incision is done to midline. Intramedullary guide is used for alignment of femoral and tibia saw cuts and component positions. Components will be cemented in position. The patella will not be resurfaced. Intraoperative local infiltration analgesia (LIA) is used for postoperative pain management. Drain is not used.
16056161|NCT02481414|Biological|PepCan|50 μg peptide + 0.3 mL Candin® per dose administered intradermally in the extremities
16056162|NCT02481414|Biological|Candin®|0.3 mL Candin® per dose administered intradermally in the extremities
16056163|NCT02481401|Behavioral|Intensive Individual Intervention Program|
16056164|NCT02481401|Behavioral|Peer-To-Peer Program Intervention|
16056165|NCT02481388|Other|Maximal exercise ramp test|The maximal exercise ramp test, symptom-limited, performed by all patients in the study was performed based on treadmill ramp protocol through ErgoPC Elite® software associated with 12-channels electrocardiogram. Respiratory variables were obtained in standard conditions of temperature, pressure and humidity (StPD), breath-by-breath, with the patient breathing through a face mask without leaks coupled to gas analyzer (Cortex - Metamax 3B, Germany).To ensure that patients reached maximum effort during the examination, only the tests which patients obtain a respiratory exchange ratio (RR) ≥1.1 were accepted .
16056166|NCT02481375|Dietary Supplement|Multiple micronutrients|12-wk supplementation of vitamin A, B1, B2, B6 ,B12, D, E, niacin, folic acid, zinc, copper, selenium, iodine
16056167|NCT02481375|Dietary Supplement|Iron|12-wk supplementation of iron
16056168|NCT02481375|Dietary Supplement|Placebo|12-wk supplementation of placebo
16056169|NCT02481362|Other|CAKE|For the CAKE condition, participants will play a computer task to earn points for cake that they can consume.
16056170|NCT02481362|Other|APRICOTS|For the APRICOTS condition, participants will play a computer task to earn points for apricots that they can consume.
16056171|NCT02481349|Other|Best Practice|Undergo standard of care
16056172|NCT02481349|Other|Informational Intervention|Receive DVD for home practice
16056173|NCT02481349|Other|Quality-of-Life Assessment|Ancillary studies
16056174|NCT02481349|Other|Questionnaire Administration|Ancillary studies
16056175|NCT02481349|Other|Yoga|Complete couple-based Hatha yoga program
16056176|NCT02481336|Other|Questionnaires|EORTC CIPN20 and EQ-5D-3L
16056185|NCT02481310|Drug|Ixazomib Citrate|Given PO
16056186|NCT02481310|Other|Laboratory Biomarker Analysis|Correlative studies
16056190|NCT02481310|Drug|Therapeutic Hydrocortisone|Given IT or intraventricularly
16056191|NCT02481310|Drug|Vincristine Sulfate|Given IV
16056192|NCT02481297|Drug|Lirilumab|3 mg/kg by vein given on Day 1 of each 28 day cycle.
16056193|NCT02481297|Drug|Rituximab|375 mg/m2 by vein weekly for the first 4 weeks on Days 1,8, 15, and 22 of Cycle 1. After Cycle 1, given on Day 1 of Cycles 2 - 12.
16056194|NCT02481284|Device|Laser Doppler perfusion imaging|LDPI is an extension of laser Doppler flowmetry (LDF) and was developed to generate a colour-coded perfusion image in a large area of skin.
16056195|NCT02481271|Behavioral|relaxation program|"relaxation and mindfulness techniques such as body scan, breathing meditation or imagination exercises
~1 week program, one introductory session and daily home practice"
16056196|NCT02481271|Behavioral|surgery education|"intensified education unit to reduce anxiety and stress, by using pictures and videos of rooms, and procedures of the planned surgery
~1 single unit in the week before the surgery"
16056197|NCT02481258|Drug|Ataciguat (HMR1766)|
16056198|NCT02481258|Other|Placebo Comparator: Matching Placebo|
16056199|NCT02481245|Drug|Bezafibrate|30 patients with Bipolar I or Bipolar II disorder who are experiencing an acute bipolar depressive episode will be given bezafibrate XR 400 mg daily added on to adequate doses of an FDA-approved anti-manic medication.
16056200|NCT02481232|Biological|freeze-dried group ACYW135 MCV|Group A, C, Y and W135 Meningococcal conjugate vaccine is suitable for immune prevention of epidemic cerebrospinal meningitis more than 2 months of age population
16056201|NCT02481219|Device|PillCam® COLON 2 procedure-CONTROL|
16056202|NCT02481219|Drug|Senna tablets|
16056203|NCT02481219|Drug|PEG|
16056204|NCT02481219|Drug|Metoclopramide|
16056205|NCT02481219|Drug|Erythromycin|
16056206|NCT02481219|Drug|SUPREP oral sulfate solution|
16056207|NCT02481219|Drug|Bisacodyl|
16056208|NCT02481219|Drug|SUPREP oral sulfate solution with Gastrografin|
16056209|NCT02481206|Device|Wearable Cardioverter Defibrillator|Wearable Cardioverter Defibrillator
16056210|NCT02481193|Drug|Cisatracurium|Different doses of cisatracurium pretreatment
16056211|NCT02481180|Drug|T0001|injection (SC) T0001 15mg weekly for 12 weeks
16056212|NCT02481180|Drug|T0001|injection (SC) T0001 30mg weekly for 12 weeks
16056213|NCT02481180|Drug|T0001|injection (SC) T0001 30mg every two weeks for 12 weeks
16056214|NCT02481180|Drug|T0001|injection (SC) T0001 50mg every two weeks for 12 weeks
16056215|NCT02481180|Drug|Enbrel|injection (SC) enbrel 50mg twice a week for 12 weeks
16056216|NCT02481154|Drug|AG881|AG-881 administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Patients may continue treatment with AG-881 until disease progression or development of other unacceptable toxicity
16056217|NCT02481141|Drug|5-ALA-SFC|Study product will be in the form of white-opaque capsules for oral administration, containing either 50, 75, or 100 mg of active 5-ALA - SFC
16056218|NCT02481141|Drug|Placebo|
16056219|NCT02481128|Procedure|without preoperative access to lymphoscintigraphy findings|axillary sentinel lymph node biopsy without access to lymphoscintigraphy findings
16056220|NCT02481089|Other|validation group|
16056221|NCT02481076|Device|Flowtron Hydroven and Coban2 Lite|The patient in the intervention group will use both compression boot and compression bandage, as described in intervention arm
16056222|NCT02481076|Other|Braun frame|The leg is elevated on a Braun frame
16056223|NCT02481076|Device|compression bandage|application of flowtron hydroven boot and compression bandage
16056224|NCT02481063|Other|Control|3 Consecutive Days Running at 80% Maximus Heart Rate
16056225|NCT02481063|Other|Eccentric Overload|Training with Eccentric Overload (Squat in Yoyo Technology) during 6 Weeks 3 Consecutive Days Running at 80% Maximus Heart Rate
16056226|NCT02481050|Drug|Eribulin Mesylate|Eribulin Mesylate will be administered as a 1.4 mg/m2 intravenous (IV) injection over 2 to 5 minutes biweekly on Day 1 and Day 15 of each 28-day cycle.
16056227|NCT02481037|Other|Primary care clinical pathway|Installing a primary care clinical pathway for managing childhood asthma into clinicians' electronic medical record (EMR) to facilitate the use of best-evidence by practitioners.
16056228|NCT02481037|Other|Asthma education|Physicians will receive web-based education through an interactive learning module regarding best management for childhood asthma and use of the primary care clinical pathway. Chronic disease management (CDM) health professionals in practices will attend asthma education sessions delivered by an asthma educator. This training will be then used by the CDM professional to provide targeted and timely asthma education to parents and children with asthma.
16056229|NCT02481037|Other|EMR embedded dashboard|An EMR embedded dashboard will deliver real-time feedback to clinicians.
16056230|NCT02481011|Drug|antithrombotic drugs|
16056231|NCT02480998|Biological|IL-YANG Flu Vaccine QIV 0.5mL|
16056232|NCT02480998|Biological|IL-YANG Flu Vaccine TIV 0.5mL|
16056233|NCT02480985|Other|Pituitary function evaluation|"Pituitary function evaluation performed at hospital discharge, 6 and 12 months
~Thyroid-stimulating hormone, free T4 and T3
~Follicle stimulating hormone, luteinizing hormone, estradiol, bioavailable testosterone
~Adrenocorticotropic hormone stimulation test
~Glucagon test (growth hormone deficit)
~Risk factors evaluation of pituitary dysfunction
~Demographic data
~Daily data (clinical exam, secondary brain injuries)
~Hormone levels on day 1, 3 and 7
~Biomarkers on day 1, 3 and 7
~Brain CT-Scan on day 1
~Pituitary MRI on day 7
~Outcome measures at 6 and 12 months
~Neurological recovery (GOSe)
~Independent functioning (FIM)
~Quality of life (EQ-5D-5L)
~Life satisfaction (LISAT-11)
~Depression (PHQ-9)"
16056234|NCT02480972|Procedure|magnetic resonance imaging|"multiparametric MRI as follows:
~diffusion weighted imaging using multiple b-values
~Fat quantification sequence
~perfusion MRI using ECCM agent
~MR elastography
~------------------------------------
~routine MRI using hepatocyte specific agent (optional in patients with focal liver lesion)"
16056235|NCT02480959|Procedure|Surgical treatment for recurrent patellar instability|Either medial plication or MPFL reconstructuion surgery
16056236|NCT02480946|Drug|MBS2320|As described in the arm descriptions
16056237|NCT02480946|Drug|Placebo|As described in the arm descriptions
16056238|NCT02480946|Drug|Methotrexate|Background therapy as described in the arm descriptions
16058490|NCT02465138|Drug|Placebo|Intravenous saline
16056239|NCT02480933|Procedure|Bilateral mastectomy|Bilateral mastectomy and imaging study of cadaveric breasts
16056240|NCT02480933|Other|Biopsy|Biopsy of BI-RADS 3 and superior lesions
16056241|NCT02480907|Behavioral|Workshop Group|Workshop support group
16056242|NCT02480907|Behavioral|Internet-based support group|Internet based support group with E-mail coaching
16056243|NCT02480894|Drug|BMS-663068|BMS-663068
16056244|NCT02480894|Drug|Maraviroc|Maraviroc
16056245|NCT02480881|Drug|BMS-663068|Investigational product
16056246|NCT02480881|Drug|Oral Contraceptive|Subject's existing combination OC tablet containing EE and progestin
16056247|NCT02480881|Drug|Loestrin 1.5/30|OC containing EE and norethindrone acetate (NEA)
16056248|NCT02480868|Device|ARTEBONE|4,3 g Bone Void Filler
16056249|NCT02480855|Other|Questionnaire and feedback|
16056250|NCT02480842|Other|Alloplastic free ROM|
16056251|NCT02480842|Other|Alloplastic limited ROM|
16056252|NCT02480842|Other|Oncoplastic free ROM|
16056253|NCT02480842|Other|Oncoplastic limited ROM|
16056254|NCT02480816|Dietary Supplement|Mineral water|Intake of 1 L per day of the mineral water (BW or CW) with main meals, crossover design
16056255|NCT02480803|Drug|Continuous intrajejunal infusion of levodopa-carbidopa|Continuous delivery of levodopa-carbidopa intestinal gel through an intrajejunal percutaneous tube (Duodopa, CLI, CILI)
16056256|NCT02480803|Device|deep brain stimulation|Bilateral deep brain stimulation (DBS) of the subthalamic nucleus (STN)
16056257|NCT02480777|Biological|Autologous Human Schwann cells|Schwann cells harvested from the sural nerve and debrided, injured sciatic nerve of the participant will be autologously transplanted along sural nerve autografts wrapped in a collagen matrix (Duragen).
16056258|NCT02480764|Drug|Azilsartan medoxomil|Azilsartan medoxomil tablets
16056259|NCT02480764|Drug|Valsartan|Valsartan 80 mg capsules
16056260|NCT02480764|Drug|Azilsartan medoxomil Placebo|Azilsartan medoxomil placebo-matching tablets
16056261|NCT02480764|Drug|Valsartan Placebo|Valsartan placebo-matching capsules
16056262|NCT02480751|Drug|Beraprost|
16056263|NCT02480751|Drug|Placebo|
16056264|NCT02480738|Behavioral|Computerized Cognitive Training Apparatus|"CoCoTA was developed through collaborative research with the Korean Institute of Science and Technology (KIST) and Primpo Co. Ltd. (www.primpo.com). It was designed to stimulate numerous cognitive domains simultaneously by using sounds and objects familiar to Korean elderly. Training themes and scenarios were developed and evaluated by six board-certified neurologists and three neuropsychologists who specialize in dementia.
~Each subject participated in a total of 24 sessions of cognitive training, which consisted of 40 minutes of training, twice per week. To assure the consistency of cognitive training, trained personnel stayed nearby the subjects to help throughout the training process."
16056265|NCT02480725|Procedure|collect CSF (Cerebrospinal fluid) sample|collecting CSF samples for thrombin activity assay
16056266|NCT02480712|Drug|SOF/VEL|400/100 mg fixed-dose combination (FDC) tablet administered orally once daily
16056267|NCT02480699|Biological|Recurring blood sample|
16056268|NCT02480699|Other|dietary survey|A dietary survey will be performed in all patients and every 3 months (4 surveys about 1 year). This survey will be given to the patient filled for 7 consecutive days. He must record during these 7 days, all of his food intake in quality and quantity. During a dialysis session this questionnaire will be taken with the patient by a dietician to better define the food intake. This surveys requires good patient compliance as well as his involvement that his collection is well within its food intake.
16056269|NCT02480686|Drug|SOF+PEG+RBV|Sofosbuvir (SOF) 400 mg tablet is administered orally once daily; Pegylated interferon alfa-2a (PEG) 180 μg was administered once weekly by subcutaneous injection; Ribavirin (RBV) was administered as a tablet orally according to body weight (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
16056270|NCT02480673|Dietary Supplement|Chia|The subject will eat 25 gr of chia in 2 oatmeal cookies at day
16056271|NCT02480673|Dietary Supplement|Oatmeal|The subject will eat 2 oatmeal cookies a day containing the exactly same quantity of oats in the oatmeal cookies with chia.
16056272|NCT02480673|Behavioral|Normocaloric diet|The healthy diet plan distribution will be 50% carbohydrate, 25 % protein, 35 % fat to less than 7 % saturated fat and less than 200 mg/d cholesterol and 20-30 g of fiber.
16056273|NCT02480660|Behavioral|Educational Video|The video highlights key elements found in the existing literature critical for transition including understanding and taking charge of their health, creating a medical summary, learning more about health insurance, introducing the idea of organizing a health care transition team and creating a plan. The video also educates patients on the opportunities to take a tour of an adult floor, talk with social workers and learn more about adult providers during their hospital stay.
16056274|NCT02480647|Drug|Levonorgestrel|20μg/day.
16056275|NCT02480647|Drug|Etonogestrel|20μg/day.
16056276|NCT02480634|Drug|Zoledronic acid|Comparison the curative effect of the high does radiotherapy and low does therapy after use the Zoledronic acid
16056277|NCT02480634|Radiation|Radiotherapy|High dose：30Gy/10f Low dose：15Gy/5f
16056278|NCT02480621|Drug|Liposomal Bupivacaine with Bupivacaine|Pain medications injected locally during surgery around affected ankle.
16056279|NCT02480608|Drug|Imatinib|
16056280|NCT02480608|Drug|Hydroxyurea|
16056281|NCT02480595|Device|Stent Graft|Endovascular repair of abdominal aortic aneurysm (EVAR)
16056282|NCT02480582|Other|Almonds|Whole raw almonds provided as a mid-morning snack - 0.9g\kg
16056283|NCT02480582|Other|Cheese Savouries|Cheese savoury crackers provided as a mid-morning snack - 0.9g/kg
16056284|NCT02480569|Other|FFR Measurement|
16056285|NCT02480556|Procedure|manual seperation of the placenta|manual separation of the placenta will be done immediately after fetal extraction & cord clamping, where the fingers of the surgeon will be insinuated between the margin of the placenta and the uterine cavity, then by sawing movement and controlled traction by the other hand till placenta is separated from the uterine cavity
16056286|NCT02480556|Procedure|Conservative separation of placenta|"Conservative separation of placenta:
~in group B but following fetal extraction and cord clamping, the placenta will be left insitu & uterus is massaged awaiting spontaneous placental separation"
16056287|NCT02480543|Drug|Misoprostol (cytotec)|
16058491|NCT02465125|Biological|red blood cell transfusion|
16056288|NCT02480530|Behavioral|Individual Feedback|Patient gets feedback reports on adherence weekly.
16056289|NCT02480530|Behavioral|Feedback Friend|In addition to individual feedback reports this information will be sent to an assigned family/friend or reciprocal peer.
16056290|NCT02480517|Device|Ultrasound|
16056291|NCT02480517|Device|Sham Ultrasound|
16056292|NCT02480504|Other|dietary intervention intermittent energy restriction|Randomized clinical trial
16056293|NCT02480504|Other|continuous energy restriction|
16056294|NCT02480491|Other|measuring cell freeDNA|measuring cell free DNA using PCR
16056295|NCT02480465|Drug|Lobelitazone 0.5mg|Lobelitazone 0.5mg, placebo of Sitagliptin 100mg, orally, 2 tablet once a day for 24 weeks with metformin
16056296|NCT02480465|Drug|Sitagliptin 100mg|placebo of Lobelitazone 0.5mg, Sitagliptin 100mg, orally, 2 tablet once a day for 24 weeks with metformin
16056297|NCT02480439|Drug|TAK-648 Tablet|Tak-648 tablet
16056298|NCT02480439|Drug|TAK-648 Oral Solution|TAK-648 oral solution
16056299|NCT02480426|Device|CT-image guidance|TIPS creation is performed under the guidance of 3D CT-image.
16056300|NCT02480426|Drug|CO2 portograms guidance|TIPS creation is performed under the guidance of two-dimensional (2D) CO2 portograms.
16056301|NCT02480413|Other|Accuracy of an algorithm and the pediatric emergency tape.|No intervention
16056302|NCT02480400|Drug|Escitalopram|Patients diagnosed with MDD and will fulfill the inclusion and exclusion criteria will start with escitalopram 10mg, according to the Summary of Product Characteristics. At week 2, patients with a baseline MADRS between 22 and 29 continue on 10mg, and patients with a baseline MADRS > 30 receive a fixed dose 20mg until the end of treatment.
16056303|NCT02480400|Drug|Escitalopram|Patients diagnosed with MDD and will fulfill the inclusion and exclusion criteria will start with escitalopram 10mg, according to the Summary of Product Characteristics. At week 2, patients with a baseline MADRS between 22 and 29 continue on 10mg, and patients with a baseline MADRS > 30 receive a fixed dose 20mg until the end of treatment.
16056304|NCT02480387|Drug|Ledipasvir/Sofosbuvir FDC|
16056305|NCT02480374|Biological|GEN-1|
16056306|NCT02480361|Device|acupuncture|Acupuncture treatment after gastric cancer surgery during 5 postoperative days
16056307|NCT02480348|Device|Polymer-free DES (Drug Eluting Stent)|
16056308|NCT02480335|Drug|bosentan|62.5 mg oral twice daily for 4 weeks, then 125 mg oral twice daily.
16056309|NCT02480322|Procedure|bariatric surgery (sleeve resection, proximal RYGB, distal RYGB)|
16056310|NCT02480296|Drug|MYK-461|
16056311|NCT02480296|Drug|Placebo|Placebo comparator
16056312|NCT02480283|Procedure|Bronchoscopy|Passage of a thin flexible tube through the mouth, into the windpipe and then into the bronchial tubes so that the study doctor can look into the lungs to perform Bronchoalveolar lavage (BAL), cytologic brushing, and protected specimen brushing.
16056313|NCT02480283|Radiation|Chest X-ray|To identify any previously undiagnosed lung disease that will either increase the risk of bronchoscopy or confound results of the study.
16056314|NCT02480283|Procedure|Venipuncture|To collect blood cells and serum for analyses.
16056315|NCT02480283|Procedure|Intravenous Catheter|To administer the appropriate medications for the bronchoscopy procedure.
16056316|NCT02480257|Behavioral|TARA|The intervention consists of four 3-week modules: 1. Autonomic regulation: Learning and practicing the ability to create a calm and safe inner state through breathing exercises and movement/physical activity. 2. Interoceptive awareness: Attention training, targeting external stimuli then sensory stimuli using short body scan exercises and guided meditations. 3.Emotion regulation: Recognizing, labeling, externalizing, and befriending emotions. 4. Metacognition, core-values, and committed action: Understanding social triggers to negative emotions and experiential avoidance strategies and their impact on obtaining desired life-goals. Home practice of TARA skills is encouraged, with breathing instructions and short, guided meditations provided via audio tracks.
16056317|NCT02480244|Behavioral|Behavioral Intervention|Intervention participants attend up to 12 educational sessions teaching them about diabetes, and modifiable lifestyle factors (behaviors) to reduce the risk of diabetes by controlling weight. Sessions are conducted by Promotoras using culturally sensitive and appropriate materials and themes. Group activities and support are also emphasized. The control participants like the intervention were measured and interviewed before and again after the intervention sessions, but received no educational instruction or materials.
16056318|NCT02480244|Other|Control|Control arm receives no health-related behavioral intervention
16056319|NCT02480231|Device|Retropubic Midurethral Sling|
16056320|NCT02480218|Other|Neuropsychological test battery|Participants will have been prescribed their endocrine therapy for the treatment of breast cancer prior to enrollment. Neuropsychological test batteries will be administered at baseline and at one-year follow-up to assess changes in cognition.
16056321|NCT02480205|Device|NeuroBox to deliver the NeuroPAP|"The patients will be studied during the following conditions:
~On conventional NIPPV device with the clinically prescribed settings (30 min)
~With NeuroPAP and no change of Pmin (=peep) (60 min)
~With NeuroPAP and adjusted Pmin (decreased by 2 cmH2O) (60 min)
~During CPAP delivered with NeuroPAP device (15 min)
~Again with original NIPPV device and settings for 30 minutes"
16056322|NCT02480192|Other|CBT for Menopausal Symptoms (CBT-Meno)|This 12-week CBT-based group treatment program consists of a combination of components including: a) psychoeducation about the nature of menopause including examination about thoughts and beliefs, b) cognitive and behavioural modification related to vasomotor symptoms, c) cognitive-behavioural strategies for depression, e) cognitive-behavioural strategies for anxiety and panic, d) sleep hygiene and cognitive-behavioural strategies for sleep difficulties, f) psychoeducation and lifestyle and behavioural modifications for urogenital complaints, and g) psychoeducation and cognitive-behavioural strategies for sexual concerns.
16056323|NCT02480179|Device|H.E.G. (hematoencephalography) based neurofeedback|H.E.G. is a relatively new neurofeedback technique which, similar to fMRI is based on differential oxygenated blood supply according to regional brain activity.
16056324|NCT02480166|Drug|8 weeks SOF/LED|Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are treatment naïve and without cirrhosis will be assigned to 8 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.
16058384|NCT02465814|Drug|Ulipristal|Ulipristal 5 mg (12 weeks), treatment break, Ulipristal 5 mg (12 weeks)
16056325|NCT02480166|Drug|12 weeks SOF/LED|Eligible and consenting patients will be treated with sofosbuvir 400 mg daily and ledipasvir 90 mg daily for 8 weeks. Patients that are not treatment naïve or have cirrhosis will be assigned to 12 weeks of treatment. The drug will be administered orally, per manufacturers' instructions, and can be taken with or without food.
16056326|NCT02480153|Biological|PF-06410293|PF-06410293 will be administered with a uniform dose regimen, which is SC injection at a dose of 40 mg every other week, throughout the study treatment.
16056327|NCT02480153|Biological|Adalimumab|Adalimumab will be administered with a uniform dose regimen, which is SC injection at a dose of 40 mg every other week, throughout the study treatment.
16056328|NCT02480140|Other|Self-regulated constraint-induced movement therapy|There were 10 tasks to practice in total, they included fold laundry, put clothes on hanger, brush teeth, dress upper garment, dress lower garment in week one; and use telephone, prepare a cup of tea, sweep floor, wash towel, wash dishes in week two. In the 4 hours when the participants had their non-hemiplegic arm in the restrain, they received one hour therapist-guided training using SR strategy on task relearning as described above. Therefore, all participants received 10 one-hour therapist-guided training sessions (daily on weekdays, total two weeks). The intervention was delivered by occupational therapist. For the rest of the 3 hours in the restrain, the participants' wearing of the restrain was monitored by the nursing staff in the ward.
16056329|NCT02480140|Other|Constraint-induced movement therapy|They practised the same 10 tasks as in the SR-CIMT and control groups. The same as the experimental intervention group (SR-CIMT), in the 4 hours when the participants had their non-hemiplegic arm in the restrain, they received one hour therapist-guided training using the strategy on task relearning as described above. Therefore, all participants received 10 one-hour therapist-guided training sessions (daily on weekdays, total two weeks). The intervention was delivered by occupational therapist. For the rest of the 3 hours in the restrain, the participants' wearing of the restrain was monitored by the nursing staff in the ward.
16056330|NCT02480140|Other|Conventional occupational therapy|They practised the same 10 tasks as in the SR-CIMT group described above. They received training for 2 weeks, 5 days a week (therapy days), the same as in the SR-CIMT and CIMT groups.
16056331|NCT02480127|Procedure|PIPELLE Endometrial injury|The endometrial injury which is induced with pipelle.
16056332|NCT02480114|Other|Educational Intervention|Undergo oral care and pain management education session
16056333|NCT02480114|Drug|Gabapentin|Given PO
16056334|NCT02480114|Other|Pain Therapy|Receive usual oral health care
16056335|NCT02480114|Other|Quality-of-Life Assessment|Ancillary studies
16056336|NCT02480114|Other|Questionnaire Administration|Ancillary studies
16056337|NCT02480114|Drug|Oxycodone/Acetaminophen|Analgesia
16056338|NCT02480114|Drug|Hydrocodone/Acetaminophen|Analgesia
16056339|NCT02480114|Drug|Fentanyl|Transdermal Analgesia
16056340|NCT02480114|Drug|Ibuprofen|NSAID Analgesia
16056341|NCT02480114|Drug|Magic Mouthwash|Oral Solution to treat mucositis
16056342|NCT02480101|Biological|H7N9 live influenza vaccine|H7N9 live influenza vaccine
16056343|NCT02480101|Biological|Placebo|Lyophilized purified allantoic fluid of chicken embryos with stabilizers
16056344|NCT02480088|Drug|Ramosetron|ramosetron 0.3 mg IV 20 min before the end of surgery and 24 h after the surgery
16056345|NCT02480088|Drug|Palonosetron|palonosetron 0.075 mg IV 20 min before the end of surgery and 24 h after the surgery.
16056346|NCT02480075|Other|Observational|Observational Study only
16056347|NCT02480062|Other|mWELLCARE|mWELLCARE intervention arm will include a software application loaded on a tablet computer that will be used by Nurse Care Coordinators (posted in community health centers) in the course of their jobs to register patients with hypertension or diabetes, to generate clinical decision support recommendations, to track these patients over time and to improve follow-up care. Decision support recommendations will be printed and given to a doctor, who will make the final call on the management plan that will be used for the patient. Registered patients will also receive customized messages on their mobile phone. In addition, at sites where network connectivity permits, the doctor may also be equipped with a doctor's app on a tablet that will be largely the same as the NCC app.
16056348|NCT02480062|Other|Usual Care|Usual care at the community health centers
16056349|NCT02480049|Drug|Asmakast|1 tablet contains 10 mg of montelukast
16056350|NCT02480049|Drug|Singulair|1 tablet contains 10 mg of montelukast
16056351|NCT02480036|Radiation|IORT with Kyphoplasty|IORT with kyphoplasty is give concurrently for the treatment of spinal metastases
16056352|NCT02480036|Device|Intrabeam®|
16056353|NCT02480023|Radiation|calcaneal quantitative ultrasound assessment|QUS for calcaneus bone of right foot will be done for this group of Pregnant women at the third trimester
16056354|NCT02480010|Drug|Pertuzumab|Participants will receive pertuzumab on Day 1 of each 3-week cycle. In Cohort A, an 840-mg loading dose will be administered prior to the 420-mg IV infusion. In Cohort B, the 1050-mg IV infusion will be administered with no loading dose.
16056355|NCT02479997|Drug|Indocyanine green|"ICG is cyanine dye used in medical diagnostics. It is used for determining cardiac output, hepatic function, and liver blood flow, and for ophthalmic angiography.
~In this study, Investigator uses ICG as a fluorescent dye which is used in medicine as an indicator substance . And it will allow detection of SLN more convenientlty."
16056356|NCT02479997|Drug|Radioisotope|Nuclear medicine uses radiation to provide diagnostic information about the functioning of a person's specific organs, or to treat them. Diagnostic procedures using radioisotopes are now routine.
16056357|NCT02479984|Procedure|Staging Laparoscopy|"Resectable pancreatobiliary cancer confirmed by radiologic studies (CT scan, MRI, PET-CT) and no evidence of distant metastasis.
~Staging laparoscopy will perform through 2 ports and a 30˚ laparoscope is inserted into the peritoneal cavity. Examining the whole abdominal wall, including the parietal and visceral peritonea, we will observe the liver surface from the dome area to the inferior surface and hepatoduodenal ligament in order to find metastatic nodules. Laparoscopic ultrasound (US) will be used to overcome in inspecting the posterior part of the liver. After complete laparoscopic examination, peritoneal lavage will be performed through the laparoscopic port."
16056358|NCT02479984|Device|Laparoscopic ultrasound|
16056359|NCT02479971|Drug|Clindamycin-gentamicin irrigation|An irrigation of the entire abdominal cavity with 500 ml gentamicin-clindamycin solution will be performed.
16058492|NCT02465112|Drug|In111-Pentetréotide|
16056360|NCT02479971|Drug|Normal saline irrigation|An irrigation of the entire abdominal cavity with 500 ml normal saline will be performed.
16056361|NCT02479958|Procedure|Rubber dam isolation|Tooth was isolated using a rubber dam isolation in order to collect the dentin samples
16056362|NCT02479958|Procedure|Tooth drying|The tooth was dried with air jet.
16056363|NCT02479958|Procedure|Dentin wash with chlorhexidine 2%|Partial carious tissue was removed with conventional dentinal curette and collection of dentin with a micropunch (Ø = 1mm) was performed. The remaining dentin was washed with chlorhexidine 2%. After that a a new dentin collection was performed at another site of the cavity, and restoration with resin-modified glass ionomer cement was placed.
16056364|NCT02479958|Procedure|Antimicrobial Photodynamic Therapy 1|Partial carious tissue was removed with conventional dentine curette and collection of dentin with a micropunch (Ø = 1mm) was performed. The remaining dentin was washed with 200 µL of O-Toluidine blue dye (0.1 mg/mL) for 60 s. After this, a red LED light source with wavelength of 630 nm was used at 100 mW power, 9.0 J of energy, for 60 s with energy density of 30.0 J/cm2 . A new dentin collection was performed after this treatment at another site of the cavity and restoration with resin-modified glass ionomer cement Vitremer was placed.
16056365|NCT02479958|Procedure|Antimicrobial Photodynamic Therapy 2|Partial carious tissue was removed with conventional dentine curette and initial collection of dentin with a micropunch (Ø = 1mm) was performed. Treatment of the remaining dentin was performed with 200 µL of methylene blue dye 0.01% for 5 min and after this, a red low level LASER light source with wavelength of 660 nm was used at 100 mW power, 9.0 J of energy, for 90 s with energy density of 320.0 J/cm2 . A new dentin collection was performed after this treatment at another site of the cavity and restoration with resin-modified glass ionomer cement was placed.
16056366|NCT02479945|Other|Obtaining biospecimen|
16056367|NCT02479932|Other|Transperitoneal cesarean technique|Pfannenstiel-Kerr technique for laparatomy and uterine entry
16056368|NCT02479932|Other|Extraperitoneal cesarean technique|Pfannenstiel incision, paravesical approach to lower uterine segment extraperitoneally and Kerr incision for uterine entry
16056369|NCT02479919|Device|Magstim® Active TBS|Non-invasive transcranial magnetic stimulation inducing changes in cortical excitability depending on the cortical target (except for sham stimulation)
16056370|NCT02479919|Device|Magstim® Sham TBS|Sham stimulation
16056371|NCT02479906|Device|Deep TMS System|Deep TMS treatments will be administered 3 times a week for 4 weeks and additional 2 booster treatments at the 5 and 9 week follow-up visits, for a total of 14 treatment sessions.
16056372|NCT02479906|Device|Sham Treatment|Sham treatments will be administered 3 times a week for 4 weeks and additional 2 booster treatments at the 5 and 9 week follow-up visits, for a total of 14 treatment sessions
16056373|NCT02479893|Procedure|polypectomy|Polyps size up to 0.8 cm will removed from the left colon.Re examination in 6 months period with biopsy from the scar of polypectomy.
16056374|NCT02479880|Drug|Tenofovir DF|300 mg tablet administered orally once daily for up to 96 weeks
16056375|NCT02479880|Radiation|DEXA Scan|Dual energy x-ray absorptiometry (DEXA) scans administered at protocol-specified time points
16056376|NCT02479867|Drug|Cefadroxil|1 tablet from test vs 1 tablet from reference
16056377|NCT02479854|Drug|Asmakast|1 chewable tablet contains 5 mg montelukast
16056378|NCT02479854|Drug|Singulair|1 chewable tablet contains 5 mg montelukast
16056379|NCT02479841|Other|Self management program|
16056380|NCT02479828|Drug|Fascia iliaca compartment block|40 ml ropivacaine 0,5% injected under fascia iliaca using ultrasound
16056381|NCT02479828|Drug|Ropivacaine|
16056382|NCT02479828|Device|ultrasound|
16056383|NCT02479828|Drug|Placebo|
16056384|NCT02479815|Dietary Supplement|Micronutrient Powder (MNP)|Every month, 15 MNPs sachets will be provided to all children 6-23 months of age with the instruction to add them to their complementary food, to enable point-of-use fortification on every alternate day. The MNPs sachets will contain 6 mg Fe together with 14 other vitamins and minerals.
16056385|NCT02479802|Biological|Albumin|"27 plasma exchange procedures using Albumin 5% (estimated 3000 mL per plasma exchange) as replacement solution:
~three weeks of intensive treatment with two plasma exchanges per week
~twenty-one weeks of maintenance treatment with one weekly plasma exchange"
16056386|NCT02479789|Drug|Lidocaine|
16056387|NCT02479789|Drug|Placebo|
16056388|NCT02479776|Biological|stem cell injection|Injection of autologous bone marrow derived stem cells
16056389|NCT02479763|Procedure|Waveform-confirmed loss-of-resistance|Using waveform analysis to confirm thoracic epidural space
16056390|NCT02479750|Device|ColdZyme® mouth spray|
16056391|NCT02479750|Device|Placebo|
16056392|NCT02479737|Device|Blood drainage post cardiac surgery using PleuraFlow System|
16056393|NCT02479724|Device|continuous non-invasive blood pressure monitor|continuous blood pressure monitoring using device in parallel with Gold Standard (A-line)
16056394|NCT02479711|Other|composite restoration|The tooth will be isolated with cotton rolls and the caries will be removed. Enamel and dentin conditionings were performed with a self-etching adhesive system (Adhese One F, Ivoclar Vivadent, Liechtenstein). Bulk fill composite (Tetric EvoCeram® , Ivoclar Vivadent, Liechtenstein) will be injected in a single bulk increment of less than 4 mm to fill the preparations. The material was condensed with a flat instrument. Once set, it will be polished with finishing cups (Enhance® , Dentsply , Milford, USA). An interproximal strip will be used to finish the final contour.
16056395|NCT02479711|Other|glass ionomer cement|The tooth will be isolated wit cotton rolls and the caries will be removed. The dentist will mix and handle the materials in accordance with the manufacturers' instructions. The material was condensed with a flat instrument. Once set, it will be polished. An interproximal strip will be used to finish the final contour. G-Coat Plus (GC, America) will be applied to the surface and margins of the restoration.
16056396|NCT02479698|Biological|Allogeneic BK-specific Cytotoxic T-lymphocytes|Given IV
16056397|NCT02479698|Other|Laboratory Biomarker Analysis|Correlative studies
16056458|NCT02479373|Other|Ren-Ex Machine|The exercise is performed once per week with individualized instruction using moderate resistance on Ren-Ex Machines, ultra-low-friction equipment to minimize force on joints.
16056459|NCT02479373|Other|Dual-Emission X-ray Absorptiometry (DEXA) scan|To study body composition
16056460|NCT02479373|Other|Biodex dynamometer|To study muscle strength
16056398|NCT02479685|Procedure|PKS BILL-PKS PlasmaSORD Versus Conventional surgical techniques|To verify if the operative time of a standard laparoscopic sacral colpopexy associated to subtotal hysterectomy for the treatment of POP could be further reduced using PKS BILL: bipolar laparoscopic loop (a laparoscopic loop using advanced bipolar energy) (Olympus Medical Systems Corp, Tokyo) and PKS PlasmaSORD (Solid Organ Removal Device) vs. conventional monopolar hook and conventional mechanic morcellator.
16056399|NCT02479672|Device|laryngoscopy|Placement of endotracheal tube. If successful intubation does not occur after the first attempt at laryngoscopy, airway equipment used in further attempts will be selected at the discretion of the attending anesthesiologist.
16056400|NCT02479672|Procedure|Manual Inline Stabilization|Manual immobilization of Patient's neck with intention to minimize movement from baseline position
16056401|NCT02479672|Device|VividTrac®|
16056402|NCT02479659|Other|HIV testing commodity reinforcement|HIV testing commodities were replenished directly (outside of the government supply) in the event of a stock-out by study staff. Treatment facilities were visited monthly to assess stock levels, and facility staff could contact study staff when stock levels were low.
16056403|NCT02479659|Other|Policy reinforcement meeting|District health officials met with facility staff to remind them of the current HIV testing policies for mothers and newborns in Zambia. Current policy states mothers with unknown or previously negative status should be tested every 3 months until the infant is 18 months of age. HIV-exposed newborns should be tested at 6 weeks and 6 months.
16056404|NCT02479659|Other|Opt-out HIV testing for mothers and newborns|"Facility staff were instructed to examine the maternal HIV status on the under-five (U-5) or antenatal care (ANC) card for all infants attending their first U-5 visit and do the following:
~If marked Confirmed Exposed (CE), the health care worker conducted the DBS test on the infant only.
~If marked, Mother Status Unknown (MSU) or Confirmed Not Exposed (CNE) the mother or caregiver was asked if the mother had ever tested HIV-positive. If yes, a DBS was done on the infant only. If no, the mother was offered an HIV antibody test in an opt-out manner."
16056405|NCT02479659|Other|Operational support for service integration|The evaluation team worked with facility staff to identify efficient allocations of staff and tailor the order of services. A key component of the operational optimization was a new patient triaging approach that sorted patient U-5 cards into bins and used separate queues for three types of patients: 1) first visit infants (six weeks), 2) second visit or later infants who required immunizations and 3) infants who were scheduled to only receive growth monitoring.
16056406|NCT02479659|Other|Community sensitization|Health facility staff were instructed to communicate all aspects of the Comprehensive Intervention during ANC appointments, in-facility child birth deliveries, and postnatal care (PNC) visits. Additionally, at six week immunization visits, mothers and caregivers received group counseling on opt-out HIV screening service and the importance of regular HIV screening for mother and child health. Finally, the research team engaged Safe Motherhood Action Groups (SMAGs), community health workers (CHWs), and active neighborhood health committee members to further increase awareness in facility catchment areas. These community members completed low-touch community sensitization over changes that would be made to U-5 services.
16056407|NCT02479646|Biological|MYL-1401H|
16056408|NCT02479646|Biological|EU-Neulasta|
16056409|NCT02479646|Biological|US-Neulasta|
16056410|NCT02479633|Other|Coronally advanced flap with connective tissue graft|"Two oblique, divergent releasing incisions extending beyond the mucogingival junction were performed. An intra-sulcular incision was performed at the buccal aspect of the involved tooth. Subsequently, a partial-thickness flap was raised beyond the MGJ. The papilla adjacent to the involved tooth were then de-epithelialized.
~The CTG was harvested using a single incision approach from the palate. The graft was positioned on the instrumented root surface immediately apical of the CEJ and then stabilized using a sling compressive crossing suture. The flap was coronally displaced 1-2 mm above the CEJ. A sling suture was placed to stabilize the flap in a coronal position, followed by interrupted sutures on the releasing incisions with an apico-coronal direction."
16056411|NCT02479620|Drug|Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL|Following atherecomy-based revascularization, Investigators will be unblinded to assignment and will treat only patients assigned to the treatment arm with the Bullfrog delivery of dexamethasone.
16056412|NCT02479607|Device|Smartphone or tablet|
16056413|NCT02479594|Behavioral|competence-feedback|competence-feedback
16056414|NCT02479594|Other|control|control group without competence-feedback
16056415|NCT02479581|Procedure|ERAS group|Intravenous infusion of flucloxacillin sodium 1g an hour before operation
16056416|NCT02479581|Procedure|ERAS group|"No routine bowel preparation;
~Normal eating 1 days before the operation;
~No drinking 2h and solid food 6h before the operation;
~Drink 10% glucose 250ml 3h before operation ;
~Gastric mucosal protective agent was given 3 days before operation(Esomeprazole Magnesium Enteric-coated tablets 40mg/d);"
16056417|NCT02479581|Procedure|ERAS group|Emphasize the preoperative psychological preparation for patients.
16056418|NCT02479581|Procedure|ERAS group|Received subcutaneous recombinant human erythropoietin (rhEPO)150（international unit/kg） once very two days from 2 days after hospital admission to 5 days postoperatively；
16056419|NCT02479581|Procedure|ERAS group|No scopolamine and morphine before surgery; No midazolam; No anti - choline drugs;
16056420|NCT02479581|Procedure|ERAS group|Solu-Medrol®:5mg/kg intravenous infusion during the surgery;
16056421|NCT02479581|Procedure|ERAS group|"Apply Transesophageal Echocardiography（TEE）after anesthesia induction;
~Goal-directed fluid management."
16056422|NCT02479581|Procedure|ERAS group|"Infusion of Human Albumin Grifol®20% 50ml;
~Ultrafiltration(TERUMO CARDIOVASCULAR SYSTEMS (TERUMO®));
~Shorten the Cardio-pulmonary Bypass line；
~Continuous near infrared spectrum monitoring of cerebral oxygen saturation(MNIR-P100（chongqingmingxi®）)"
16056423|NCT02479581|Procedure|ERAS group|Monitor urine volume closely, over 0.5ml/kg·h.
16056424|NCT02479581|Procedure|ERAS group|Protective ventilation strategy：Low tidal volume about 6~8ml/kg and positive end expiratory pressure（PEEP） combined with lung recruitment maneuver
16056461|NCT02479373|Other|Sub-maximal test|To study lung capacity, a sub-maximal (limited exercise) test on a stationary bicycle is performed.
16056462|NCT02479373|Other|Quality of life questionnaires|
16056463|NCT02479347|Drug|Chlorhexidine|Preoperative skin preparation with tinted chlorhexidine gluconate 2% in 70% isopropyl alcohol administered with single-dose applicator
16056425|NCT02479581|Procedure|ERAS group|"Bilateral thoracic paravertebral block before induction of anesthesia;
~Fast channel anesthesia:
~Induction use Sufentanil 0.5~1ug/kg, Vecuronium for Injection 0.15mg/kg and Etomidate 0.2~0.6mg/kg; ②. Maintain use Remifentanil Hydrochloride for Injection 0.1~0.4ug/kg·min, Propofol Injection 2~6mg/kg·h, Sevoflurane 0.5~1.5（minimum alveolar concentration） and Infusing Dexmedetomidine which load dose 0.5μg/kg in 10min then changed into 0.5-1.0μg/kg·h,Vecuronium 0.06~0.12mg/kg·h; ③. Intravenous hydromorphone Hydrochloride Injection 0.15mg/kg before surgery over."
16056426|NCT02479581|Procedure|ERAS group|"Drink water after 6h, 200ml once, 2~3 times / day，
~early ambulation，mobilization within 48 h,
~Intravenous the conventional antiemetic drugs Tropisetron hydrochloride Injection 12mg qd；
~Intravenous the lansoprazole 30mg q12h."
16056427|NCT02479581|Procedure|Conventional control group|Routine preoperative psychological preparation for patients.
16056428|NCT02479581|Procedure|ERAS group|After operation use Ropivacaine 100mg infiltrating intercostal wound and self-controlled intravenous analgesia pump is applicable(Sufentanil 0.05ug/kg·h combine with Ketamine 40ug/kg·h).
16056429|NCT02479581|Procedure|Conventional control group|"Routine bowel preparation;
~Liquid food eating 2 days before the operation;"
16056430|NCT02479581|Procedure|Conventional control group|Intramuscular injection of scopolamine 0.3mg combined with morphine 10mg before surgery;
16056431|NCT02479581|Procedure|Conventional control group|"Induction use Sufentanil 0.5~1ug/kg, Vecuronium 0.15mg/kg and Etomidate 0.2~0.6mg/kg,Midazolam0.05~0.1mg/kg ;
~Maintain use Sufentanil 1~2ug/kg·h, Propofol 4~12mg/kg·h, Sevoflurane 1~3(minimal alveolar concentration)， Vecuronium 0.06~0.12mg/kg·h;"
16056432|NCT02479581|Procedure|Conventional control group|Use self-controlled intravenous analgesia pump containing Sufentanil 0.07ug/kg·h
16056433|NCT02479581|Procedure|Conventional control group|Intravenous infusion of dexamethasone 20mg during the surgery
16056434|NCT02479581|Procedure|Conventional control group|Intravenous infusion of flucloxacillin sodium 1g before the operation
16056435|NCT02479568|Dietary Supplement|Control|500 mL (250 mL; 2 times/day) of placebo drink for 12 weeks
16056436|NCT02479568|Dietary Supplement|100% Florida OJ|500 mL (250 mL; 2 times/day) of 100% Florida OJ for 12 weeks
16056437|NCT02479568|Dietary Supplement|100% Florida OJ-enriched|500 mL (250 mL; 2 times/day) of 100% Florida OJ-enriched for 12 weeks
16056438|NCT02479555|Drug|Dexamethasone sodium phosphate injection, USP, 4 mg/mL|"Post-balloon angioplasty revascularization, the unblinded Pharmacist will prepare a sterile 20 mL syringe (Luer locking) with 16 mL of investigational drug or placebo per assignment. The unblinded Pharmacist provides syringe to investigator. Syringe shall only be labeled with the study number, patient number, randomization number and Investigational Drug.
~Investigational Drug will be administered via Bullfrog Micro-Infusion Device."
16056439|NCT02479542|Other|Standard Gauze Dressing|Following consenting of participant, the wound will be photographed with the Wound Zoom imaging system and measured for greatest length, width, and depth. For patients randomized to the control arm, only standard gauze dressings will be applied and changed daily. Wounds with the standard gauze dressings will be photo-documented and measured with the same variables every 72 hours. Wounds and dressing will be evaluated daily for drainage, exudate, presence of infection, and gauze dressings will be changed daily.
16056440|NCT02479542|Device|WiCare NPWT dressing|Following consenting of participant, the wound will be photographed with the Wound Zoom imaging system and measured for greatest length, width, and depth. For patients randomized to the simplified NPWT arm, the standard gauze dressing will be placed then the the WiCare NPWT dressing will be applied. Wounds and WiCare NPWT device will be evaluated daily for drainage, exudate, presence of infection, drainage in pump, integrity of air tight seal. Wounds will be changed by protocol with photo documentation every 72 hours for a total of 18 days or achievement of primary endpoint.
16056441|NCT02479529|Drug|Norepinephrine|Administration and weaning of norepinephrine is based on dynamic arterial elastance
16056442|NCT02479529|Drug|Norepinephrine|The usual procedure of withdrawal norepinephrine is based on hemodynamic parameters (blood pressure, cardiac output), clinical (cutaneous perfusion, mottling, hourly diuresis) and biological (SVO2, arterial lactate).
16056443|NCT02479516|Behavioral|Community Health Assessment Program Philippines (CHAP-P)|
16056444|NCT02479503|Procedure|Antibiotic prophylaxis in adult heart transplantation|
16056445|NCT02479490|Drug|Prednisone + Everolimus|"Prednisone + Everolimus: Everolimus is formulated as tablets of 5-10 mg strength, blister-packed under aluminium foil in units of 10 tablets. Prednisone will be dispensed to patients at the dose of 5 mg twice daily (BID). Everolimus at dose of 10 mg (one 10 mg tablet or two 5 mg tablets). Both drugs will be self-administered orally, continuously from Day 1 (Visit 2) until progression of disease, unacceptable toxicity, death or discontinuation for any other reason.
~A treatment cycle consists of 28 days."
16056446|NCT02479477|Other|kinesio therapy|during for fifteen minutes the nursing assistants will perform stretching exercises and muscle relaxation of large muscle groups the orthostatic position
16056447|NCT02479464|Genetic|Genotyping results|Genotyping results provided in Phase II
16056448|NCT02479451|Drug|Theophylline|The study medication will be provided by Foundation Care.
16056449|NCT02479438|Other|Diagnosed with GERD|Recording of patient outcomes
16056450|NCT02479425|Procedure|patient positioning|positioning patients, every 2 hours, either to standard (right, back, left sides) or only to right and left sides
16056451|NCT02479412|Drug|800 μg AZD7594 once daily|Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
16056452|NCT02479412|Drug|250 µg AZD7594 once daily|Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
16056453|NCT02479412|Drug|58 µg AZD7594 once daily|Once daily dosing of 800 µg AZD7594 for 14 days; each dose of AZD7594 inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
16056454|NCT02479412|Drug|Placebo once daily|Once daily dosing of Placebo to AZD7594 for 14 days; each dose of Placebo inhalation powder will be administered via a dry powder monodose inhaler as 2 hard capsules with 2 inhalations per capsule
16056455|NCT02479412|Drug|Salbutamol|Inhalation as needed
16056456|NCT02479399|Drug|ipragliflozin|Tablets
16056457|NCT02479386|Other|No intervention|No intervention was administered in this study.
16056464|NCT02479347|Drug|Povidone-Iodine|Preoperative skin preparation with povidone-iodine 10% aqueous solution
16056465|NCT02479334|Other|Fat challenge breakfast|In this intervention, subjects are asked to consume 200 ml control drinks (non-energy flavored water). Following 10 min. beverage consumption, subjects will be given standardized high fat breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 20:60:20
16056466|NCT02479334|Other|Fat challenge breakfast+spices|In this intervention, subjects are asked to consume 200 ml spices drinks (non-energy flavored water + spices extract). Following 10 min. beverage consumption, subjects will be given standardized high fat breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 20:60:20
16056467|NCT02479334|Other|Carbohydrate challenge breakfast|In this intervention, subjects are asked to consume 200 ml control drinks (non-energy flavored water). Following 10 min. beverage consumption, subjects will be given standardized high carbohydrate breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 60:20:20
16056468|NCT02479334|Other|Carbohydrate challenge breakfast+spices|In this intervention, subjects are asked to consume 200 ml spices drinks (non-energy flavored water + spices extract). Following 10 min. beverage consumption, subjects will be given standardized high carbohydrate breakfast corresponding to % Energy of Carbohydrate:Fat:Prot / 60:20:20
16056469|NCT02479321|Other|GDT based on noninvasive monitoring|"Before entering the operating room, hemodynamic optimization start by optimizing preload with Fluid Challenge according to evidence-based GDT protocols. Once stabilized the cardiovascular system after induction of anesthesia, hemodynamic optimization continue with Mini Fluid Challenge.
~In the intraoperative period, hemodynamic optimization is based on maintaining systolic blood pressure and stroke volume. A Mini Fluid Challenge is administered to patients who respond to volume or a vasoactive drug according cardiac index for non-responders."
16056470|NCT02479321|Device|System ClearSight® and Platform EV Clinic 1000®|Hemodynamic control is held by non-invasive continuous monitoring techniques (system ClearSight® and Platform EV Clinic 1000®). Monitored variables: blood pressure, heart rate, oxygen saturation, cardiac output, cardiac index, stroke volume and stroke volume index.
16056471|NCT02479308|Drug|Moxifloxacin|Single administration
16056472|NCT02479308|Drug|ALKS 5461|Daily administration for a total of 12 dosing days
16056473|NCT02479308|Drug|Placebo|Placebo will be matched to Moxifloxacin or ALKS 5461
16056474|NCT02479295|Device|Tenckhoff catheter|Peritoneal dialysis catheters for long term use
16056475|NCT02479282|Procedure|natural cesarean section|
16056476|NCT02479282|Procedure|traditional cesarean section|
16056477|NCT02479269|Other|Aerobic exercise|Aerobic exercise for 8 weeks
16056478|NCT02479256|Drug|Clomiphene citrate|Women will receive one tablet of clomiphene citrate oral tablets 50 mg (Clomid®, aventis/Egypt) twice daily 12 hours apart (total dose 100 mg daily) from the 3rd day of the menses for 5 days, for only one menstrual cycle.
16056479|NCT02479256|Drug|Tamoxifen Placebo|Women will receive one tablet of placebo of tamoxifen oral tablets twice daily 12 hours apart from the 3rd day of the menses for 5 days, for only one menstrual cycle.
16056480|NCT02479256|Drug|Tamoxifen|Women will receive one tablet of tamoxifen oral tablets 10 mg (Tamoxifen®, amriya/Egypt) twice daily 12 hours apart (total dose 20 mg daily) from 3rd day of the menses for 5 days, for only one menstrual cycle.
16056481|NCT02479256|Drug|Clomiphene citrate placebo|Women will receive one tablet of placebo of clomiphene citrate twice daily 12 hours apart from 3rd day of the menses for 5 days, for only one menstrual cycle.
16056482|NCT02479230|Biological|tumor blood vessel antigen peptide-pulsed alpha-type-1 polarized dendritic cell vaccine|Given ID
16056483|NCT02479230|Drug|gemcitabine hydrochloride|Given IV
16056484|NCT02479217|Drug|Docetaxel|
16056485|NCT02479217|Drug|Xeloda|
16056486|NCT02479204|Drug|ACT-334441 2 mg|capsule containing ACT-334441 at a strength of 2 mg
16056487|NCT02479204|Drug|ACT-334441 4 mg|capsule containing ACT-334441 at a strength of 4 mg
16056488|NCT02479204|Drug|Placebo|ACT-33441-matching placebo
16056489|NCT02479204|Drug|Atenolol|film-coated tablet containing atenolol at a strength of 50 mg
16056490|NCT02479204|Drug|Diltiazem ER|film-coated tablet containing diltiazem at a strength of of 120 mg
16056491|NCT02479191|Device|Ovation Abdominal Stent Graft Platform|
16056492|NCT02479178|Drug|BIND-014 (docetaxel nanoparticles for injectable suspension)|docetaxel nanoparticles for injectable suspension
16056493|NCT02479165|Drug|Ibuprofene|The Ibuprofene group is given an ibuprofen based analgesic regimen, to be compared with the standard opiod based regimen.
16056494|NCT02479165|Drug|Oxycodone|The opioid group is given an oxycodone based analgesic regimen.
16056495|NCT02479152|Device|LUCAS2 AD|LUCAS™ 2AD with compressions like the standard LUCAS™ 2 but added decompressions above the initial start position.
16056496|NCT02479139|Biological|Vehicle|Vehicle for ANT-1207 liniment formulation without active ingredient.
16056497|NCT02479139|Biological|ANT-1207|Botulinum toxin Type A topical liniment (ANT-1207).
16056498|NCT02479113|Procedure|Blood sampling|At 12 - 32 weeks: All patients need blood sampling for OGTT + insulin + C-peptide + fasting triglyceride + NEFA At 36 weeks/ delivery: All patients need blood sampling for fasting glucose + insulin + C-peptide + fasting triglyceride + NEFA At 36 weeks/ delivery: only GDM patients need blood sampling for HbA1c + fructosamine
16056499|NCT02479100|Diagnostic Test|Contrast Enhanced Spectral Mammogram|Undergo a Contrast Enhanced Spectral Mammogram in additional to standard of care
16056500|NCT02479087|Drug|Plasma-derived FVIII/VWF concentrate|"The investigational treatment is with lyophilized plasma-derived Factor VIII. The product belongs to the factor VIII concentrates class, containing also VW Factor in an average ratio VW/VIII of > 1: 4.5.
~The product is as a powder and a solvent solution for continuous infusion of Factor VIII. The specific activity of Factor VIII is of approximately 80 IU/mg protein.
~The number of units of FVIII administered is expressed in International Units (IU), which are consistent with current WHO standards for products containing Factor VIII. The activity of Factor VIII in plasma is expressed either as a percentage (compared to normal human plasma) or in International Units (compared to the international standard for FVIII in plasma)."
16056501|NCT02479074|Drug|Montelukast (High FeNO group)|Montelukast 10 mg film-coated tablet contains montelukast sodium equivalent to 10 mg montelukast patients to take (oral use) one tablet per day for 28 days
16056612|NCT02478203|Device|Glidescope|videolaryngoscope for difficult airway
16056502|NCT02479074|Drug|Prednisolon, Montelukast (High FeNO)|Prednisolone 5 mg, patients to take 4 tablets per day for 14 days then take Montelukast 10 mg tablet per day for another 14 days.
16056503|NCT02479074|Drug|Montelukast (Low FeNO group)|Montelukast 10 mg film-coated tablet contains montelukast sodium equivalent to 10 mg montelukast patients to take one tablet per day for 28 days
16056504|NCT02479048|Dietary Supplement|Test meal 1|High fat meal (HF) with ½ avocado (~68g), matched to CM for energy content; not matched for macronutrient content or type (e.g., fat type).
16056505|NCT02479048|Dietary Supplement|Test meal 2|High fat meal (HF) with 1 avocado (~136g) matched for energy but not macronutrient content or type.
16056506|NCT02479048|Dietary Supplement|Control Meal (CM)|High carbohydrate, high saturated fat control meal (CM) without avocado.
16056507|NCT02479035|Dietary Supplement|Red raspberry meal 1|~125 g fresh weight (1 cup equivalent)
16056508|NCT02479035|Dietary Supplement|Red raspberry meal 2|~250 g fresh weight (2 cup equivalent)
16056509|NCT02479035|Dietary Supplement|Control meal|0 g red raspberry
16056510|NCT02479022|Drug|Insulin 320|Subjects will be randomised to receive a single dose of Insulin 320 orally, at 7 escalating dose levels from 300 nmol to 21600 nmol. Progression to next dose level will be based on a safety evaluation.
16056511|NCT02479022|Drug|insulin glargine|As an open label active comparator, subjects will be randomised to receive a single dose of insulin glargine subcutaneously (s.c., under the skin), at all dose levels. The insulin glargine dose will be the same at all dose levels.
16056512|NCT02479022|Drug|placebo|Subjects will be randomised to receive a single dose of placebo orally as a comparator Insulin 320, at all dose levels.
16056513|NCT02479009|Device|Fluoroscopy|Each patient will undergo fluoroscopy-imaging evaluation in the office to determine whether the fracture moves (instability). The investigators will deviate the wrist from ulnar to radial and back in posteroanterior, oblique and lateral views with the wrist in neutral flexion. Any angulation or translation at the fracture site or more than one millimeter displacement or gap will be considered as a sign of instability. The fluoroscopy will be viewed and an image showing the largest gap will be saved. The diagnosis of instability (which is the same as displacement with this test) will be made by consensus of the research team.
16056514|NCT02478996|Other|Internet-based exercise program|Patients undergo internet-based perioperative exercise program (iPEP), including daily endurance, resistance and ventilation training
16056515|NCT02478983|Device|LMA Supreme|The device will be inserted according to manufacturer's guideline. Time of insertion will be recorded. The oropharyngeal airway leak pressure will be measured when the device successfully inserted. The time taken to insert the LMA is recorded and the insertion success rate is documented. The larynx will be visualized with fibreoptic bronchoscope inserted through the LMA. Intraoperative complications will be recorded.
16056516|NCT02478983|Device|LMA Proseal|The device will be inserted according to manufacturer's guideline. Time of insertion will be recorded. The oropharyngeal airway leak pressure will be measured when the device successfully inserted. The time taken to insert the LMA is recorded and the insertion success rate is documented. The larynx will be visualized with fibreoptic bronchoscope inserted through the LMA. Intraoperative complications will be recorded.
16056517|NCT02478970|Device|Konan SP4000|current standard of care at Kellogg Eye Center
16056518|NCT02478970|Device|NIDEK CEM-350|newly marketed device
16056519|NCT02478957|Drug|PA101|40 mg PA101 administered via inhalation three times daily for 6 weeks
16056520|NCT02478957|Drug|Placebo|matching placebo administered via inhalation three times daily for 6 weeks
16056521|NCT02478944|Device|Manometry|Flexible tube catheter pressure measurement of oesophageal contractions. Measurement without any sedation, transnasal
16056522|NCT02478918|Other|Phone call|Automated phone call reminder
16056523|NCT02478905|Other|Influenza|
16056524|NCT02478892|Device|prophylactic endoscopic ultrasound or MRI of the abdomen|The patients will be followed up clinically with routine, prophylactic endoscopic ultrasound or MRI surveillance every 12 months for a duration of 10 years
16056525|NCT02478879|Drug|ZP-PTH|Patch applied daily for 30 minutes, 14 days
16056526|NCT02478879|Drug|FORTEO|Subcutaneous injection administration daily for 14 days
16056527|NCT02478866|Drug|BPI-9016M|Seven dose cohorts will be evaluated, including 100mg, 200mg, 300mg, 450mg，600mg, 800mg, 1000mg. BPI-9016M will be administered orally to patients once daily for each dose cohort.
16056528|NCT02478853|Other|Implementation of a new regional care framework|Integrated care framework for the prevention and management of cardio-metabolic chronic diseases in primary care
16056529|NCT02478840|Drug|Lamazym|recombinant human alpha-mannosidase
16056530|NCT02478827|Behavioral|Cognitive training|The neurocognitive training program will be provided by an online platform called BrainGymmer (https://www.braingymmer.com/en/brain-games/). Users will receive an account where they will only have access to the training games they have been assigned to and where their activity will be logged. Participants randomized one of the cognitive training arms will complete the training games for 30 minutes per day, 5 days a week, for a total of 10 weeks.
16056531|NCT02478814|Dietary Supplement|Amino Acid Intake|Amino acid intakes will be varied at 0.2-2.6 g/kg/day
16056532|NCT02478801|Dietary Supplement|amino acids intake|amino acids intakes will be varied at 0.2-2.8 g/kg/day
16056533|NCT02478788|Drug|mixed amphetamine salts-extended release (MAS-XR)|MAS-XR is a psychostimulant medication composed of amphetamine and dextroamphetamine, has been systematically studied in adolescents with ADHD, and is FDA-approved for the treatment of ADHD in adolescents.
16056534|NCT02478788|Drug|Placebo|Pills with no medication in it
16056535|NCT02478775|Drug|Degarelix (GnRH antagonist)|Day-1: Blood samples will be obtained every 10 minutes for 10 hours. After 10 hours of blood samples have been collected, the GnRH antagonist degarelix will be given subcutaneously.
16056536|NCT02478775|Drug|recombinant FSH|Day-2: Blood samples will again be obtained every 10 minutes for 10 hours. Repeated boluses of exogenous recombinant FSH (rFSH) will be given by IV during this 10 hour visit.
16056537|NCT02478762|Procedure|Normal glycemic control|Use diet, physical exercise of insulins to reach normal glycemic control.
16056538|NCT02478762|Procedure|Low glycemic control|Use diet, physical exercise of insulins to reach low glycemic control.
16056539|NCT02478749|Procedure|arm retraction|gently pulling through the ipsilateral arm to the knee
16056613|NCT02478203|Device|direct laryngoscopy|gold standart for intubation
16056540|NCT02478736|Other|No actual intervention|Contact with enrolled subjects requires application of ceberal oximetry electrodes and the preoperative ultrasound (transcranial doppler) of the both MCA. No actual intervention done to subject.
16056541|NCT02478723|Device|Sonendo GentleWave™ System|The Sonendo GentleWave System is intended to prepare, clean, and irrigate 1st and 2nd molar teeth indicated for root canal therapy.
16056542|NCT02478710|Drug|Aerosolized Tobramycin or Vancomycin|Tobramycin: 300 mg diluted in 5 mL of 0.9% normal saline q.12h. Vancomycin: 125 mg diluted in 5 mL 0.9% normal saline q.8h.
16056543|NCT02478710|Drug|Aerosolized Placebo|Placebo tobramycin: 5 ml 0.9% normal saline q. 12h. Placebo vancomycin: 5m 0.9% normal saline q. 8 hr.
16056544|NCT02478697|Behavioral|ProChange ExpertSystem|The computer program assesses stage of change and TTM constructs of temptations, decisional balance, and processes of change. Repeat intervention contacts occur at baseline, 3- and 6-months follow-up, providing iterative computerized feedback reflecting prior responses with encouragement for quitting smoking and relapse prevention.
16056545|NCT02478684|Other|30 Seconds of placental blood transfusion|By delaying clamping of the cord blood for 30 seconds, blood will be allowed to move from the placenta to the premature infant
16056546|NCT02478684|Other|60 Seconds of placental blood transfusion|By delaying clamping of the cord blood for 60 seconds, blood will be allowed to move from the placenta to the premature infant
16056547|NCT02478671|Device|TR Band|The radial artery will be compressed using a Terumo TR Band and artery diameter and perfusion will be measured
16056548|NCT02478658|Other|exercise training|high-intensity resistance training
16056549|NCT02478645|Drug|ramosetron 0.3|The ramosetron 0.3 group receives ramosetron 0.3 mg at the end of surgery.
16056550|NCT02478645|Drug|ramosetron 0.45|The ramosetron 0.45 group receives ramosetron 0.45 mg at the end of surgery.
16056551|NCT02478645|Drug|ramosetron 0.6|The ramosetron 0.6 group receives ramosetron 0.6 mg at the end of surgery.
16056552|NCT02478632|Drug|Subjects do not receive study medication in this study 202094|Participants do not receive study medication in this study 202094.
16056553|NCT02478619|Other|IMT group|"Patients will be instructed to do a daily inspiratory muscle training at home with the preset load at 50% of the maximal inspiratory pressure, during 30 minutes for 4 weeks before bariatric surgery.
~They will also receive the routine physical therapy in the post operative period."
16056554|NCT02478619|Other|Control group|Patients will be instructed to do a daily inspiratory muscle training at home with the minimal inspiratory load of the respiratory resistance device, during 30 minutes for 4 weeks before bariatric surgery. They will also receive the routine physical therapy in the post operative period.
16056555|NCT02478606|Other|Muscle Stretching Exercises|The training consists of a four-week program of passive stretching exercise with three times week/sessions with interval of 48 hours between them. Each session will consist of carrying out a single repetition of stretching exercise with 30s of duration, static or PNF, according to the group to which voluntary membership. The two lower members receive training but only the lower limb data drawn will be used for analysis.
16056556|NCT02478593|Behavioral|Educational booklet|Participants in the intervention group will receive an 8-page booklet that includes a list of generic and brand benzodiazepine names, benzodiazepine medication knowledge test, information about the associated risks of benzodiazepine use, and a list of safe alternative to their potentially inappropriate medication, as well as a stepwise tapering method. Recommendations to discuss decreasing use of benzodiazepines with physicians as well as to consult physicians before stopping any medication are also advised in the booklet. Participants in the control group will receive a booklet, produced by the Centers for Disease Control and Prevention, containing information regarding the important of exercise for seniors.
16056557|NCT02478580|Drug|Nuvigil|Patients will receive Nuvigil before the surgery
16056558|NCT02478580|Drug|Placebo|Placebo will be given before surgery
16056559|NCT02478567|Other|Rotator Cuff Training|four specific band-resisted strength training exercises for scapula
16056560|NCT02478567|Other|Scapular Training|four specific band-resisted strength training exercises for rotator cuff
16056561|NCT02478554|Other|Customized fetal growth curves|Fetal weight will be plotted against growth curves specific for height, weight, parity and ethnicity
16056562|NCT02478541|Other|Sugar study|Subjects are given a single test meal on two study days that has a sugary drink that varies in the amount of fructose and glucose it contains. They consume the same amount of fat on both study days.
16056563|NCT02478528|Device|Energy-Light lamp|Exposure of the subject, at 5am, to the light source of Energy-Light lamp (Philips)
16056564|NCT02478528|Device|Luminettes lamp|Exposure of the subject, at 5am, to the light source of Luminettes lamp (Lucimed)
16056565|NCT02478528|Other|control condition|No exposure of the subject to any light sources (control condition)
16056566|NCT02478515|Drug|Ranibizumab|Intraviteal injection of 0.5mg ranibizumab
16056567|NCT02478502|Drug|cabazitaxel|cabazitaxel is given to patients with progressive testicular cancer after cisplatin-based chemotherapy
16056568|NCT02478489|Drug|Oral naltrexone (PO-NTX)|oral naltrexone
16056569|NCT02478489|Drug|Extended-release injectable naltrexone (XR-NTX)|injectable naltrexone
16056570|NCT02478463|Drug|Cabotegravir tablet 30 mg once daily for 28 days.|GSK1265744B, lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycolate, magnesium stearate, Aquarius film-coating, white BP18237
16056571|NCT02478463|Drug|Cabotegravir injection 3 mL (200 mg/mL) IM given once on Day 1.|Cabotegravir will be supplied as sterile suspension for injection 200 mg/mL vial. Each vial appears as sterile white to slightly colored suspension containing 200 mg/mL of CAB for administration by intramuscular (intragluteal) injection and will be administered as 1 × 3 mL Injections (3 mL [600 mg] total) IM given once on Day 1 of injection phase
16056572|NCT02478450|Biological|Q-Cells|cellular therapeutic comprised of human cells of the glial lineage
16056573|NCT02478437|Procedure|Conventional radiofrequency ablation (RFA)|A conventional RFA electrode with a 10mm active tip will be used. RFA lesions will be performed for 90 seconds with the maximum electrode temperature raised to 80°C.
16056574|NCT02478437|Procedure|Cooled Radiofrequency Ablation (CRFA)|Following 18G C-RFA electrode positioning, 1cc of 2% lidocaine will be injected through the introducer needle for anesthesia during the ablation. The maximum electrode temperature is 60°C.
16056614|NCT02478190|Other|Tight control: goal glucose 350 mg/dL or lower|Goal glucose at discharge will be 350 mg/dL or less.
16056575|NCT02478424|Drug|Cannabidiol|"Patients will receive standard GVHD prophylaxis consisting of cyclosporine A twice daily starting on day -1 with target trough levels of 200-400 ng/mL and a short course of methotrexate (15 mg/ m2 on day 1 and 10 mg/ m2 on days days 3 and 6). Patients transplanted from unrelated donors will receive ATG Fresenius at a low dose of 5 mg/kg on days -3 to -1.
~Patients will be given oral CBD 150 mg BID starting 7 days before transplantation until day 100."
16056576|NCT02478424|Drug|cyclosporine|
16056577|NCT02478424|Drug|Methotrexate|
16056578|NCT02478411|Procedure|Cycle ergometer physiotherapy|15 minutes of cyclo ergometer physiotherapy with MOTOmed ® Letto 2 device with passive, motor-assisted and active-resisted exercise of the lower and upper extremity, and 15 minutes of conventional physiotherapy
16056579|NCT02478411|Procedure|Conventional physiotherapy|30 minutes of conventional physiotherapy
16056580|NCT02478398|Biological|Short ragweed pollen allergen extract|One sublingual tablet containing 12 units of Amb a 1-U, once daily (QD) for up to 35 weeks.
16056581|NCT02478398|Biological|Placebo|One placebo sublingual tablet, QD for up to 35 weeks.
16056582|NCT02478398|Drug|Self-injectable epinephrine|Intramuscular (IM) injection with suggested doses of 0.15 mg for participants weighing 15-30 kg (33-66 pounds) or 0.3 mg for participants weighing ≥30 kg (≥66 pounds), as needed for severe allergic reactions. Epinephrine was only provided in countries/study sites where it was a regulatory requirement.
16056583|NCT02478398|Drug|Albuterol/Salbutamol|Inhalation of albuterol 90 mcg/puff or salbutamol 100 mcg/puff metered dose inhaler (MDI), as needed as asthma rescue medication for those participants with asthma
16056584|NCT02478398|Drug|Loratadine|5 mg (1 mg/mL syrup or 5 mg tablet) for participants 5 years old or 10 mg (1 mg/mL syrup or 10 mg tablet) for participants 6 to 17 years old, as needed for rhinoconjunctivitis symptoms
16056585|NCT02478398|Drug|Olopatadine|Opthalmic solution, 1 drop (0.1%) per affected eye twice daily (BID), as needed for rhinoconjunctivitis symptoms
16056586|NCT02478398|Drug|Mometasone furoate monohydrate|Intranasal spray, at doses of 1 spray (50 mcg/ spray) per nostril for participants 5 to 11 years old or 2 sprays (50 mcg/spray) per nostril for participants 12 to 17 years old, as needed for rhinoconjunctivitis symptoms
16056587|NCT02478385|Other|Supportive care in a specially designed labour room|Light and sound effects, homelike design in furniture and wall paper, sound insulation of walls, covering medical devices in walls, apparatus, and cupboards
16056588|NCT02478372|Drug|Patient Controlled Epidural (PCEA)|Following the operation, 4ml of 0.25% levobupivacaine was administered and the catheter was connected to a PCEA. Self-medication with a bolus 2ml of 0.125% bupivacaine via the PCEA system with a lockout time of 15 minutes until the following morning (post-operative day one) when it was stopped.
16056589|NCT02478372|Drug|Local Infiltration Analgesia (LIA)|Subcutaneous infiltration during surgery using 200ml of 0.2% plain ropivacaine.
16056590|NCT02478359|Behavioral|Physical Activity Coaching (Walk On!)|The 12-month Walk On! intervention included a baseline in-person assessment, collaborative monitoring of steps using two types of activity sensors, semi-automated step goal recommendations using an interactive voice response system or web application, ongoing individualized reinforcement from a physical activity coach, and peer/family support.
16056591|NCT02478346|Drug|Fluorescein Sodium|Conventional microsurgical and biopsy procedures and techniques including histopathology and intraoperative imaging will be performed through the completion of the surgery. The surgeon will resect and remove what he believes is the tumor based on previously known criteria (standards of care) regardless of what the Fluorescein angiography demonstrates. For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.
16056592|NCT02478333|Drug|ALS-008176 (250 mg)|Participants will receive ALS-008176, 250 mg oral suspension once on Day 1 under fasted conditions.
16056593|NCT02478333|Drug|ALS-008176 (500 mg)|Participants will receive ALS-008176, 500 mg oral suspension once on Day 1 under fasted conditions.
16056594|NCT02478333|Drug|ALS-008176 (750 mg)|Participants will receive ALS-008176, 750 mg oral suspension once on Day 1 under fasted conditions.
16056595|NCT02478333|Other|Placebo|Participants will receive placebo oral suspension once on Day 1 under fasted conditions.
16056596|NCT02478320|Drug|Ilorasertib|200 mg administered by mouth twice daily on Days 1, 8, and 15 of each 28-day cycle.
16056597|NCT02478307|Other|Cognitive Therapy|
16056598|NCT02478307|Other|Mindfulness Meditation|
16056599|NCT02478307|Other|Mindfulness-Based Cognitive Therapy|
16056600|NCT02478294|Procedure|Thoracoscopic LAA Excision plus AF Ablation|In this group, patients receive thoracoscopic LAA excision plus AF ablation, which means thoracoscopic left atrial appendage excision plus atrial fibrillation ablation.
16056601|NCT02478294|Drug|Warfarin or Novel Oral Anticoagulants|In this group, patients receive warfarin or novel oral anticoagulants
16056602|NCT02478281|Drug|Methylene Blue|
16056603|NCT02478268|Drug|Hyperpolarized 129-Xenon gas|Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject TLC followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.
16056604|NCT02478268|Device|MRI|Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion.
16056605|NCT02478255|Drug|Hyperpolarized 129-Xenon gas|Hyperpolarized xenon will be administered in multiple doses in volumes up to 25% of subject total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.
16056606|NCT02478255|Device|MRI|Conventional 1H MRI will be used to provide anatomical reference scans, as well as pulmonary perfusion.
16056607|NCT02478242|Drug|Nafamostat mesilate|nafamostat mesilate use for anticoagulation
16056608|NCT02478242|Drug|Normal saline|
16056609|NCT02478229|Drug|Sofosbuvir (SOF) and Ledipasvir (LDV)|
16056610|NCT02478216|Procedure|Remote ischemic preconditioning|The tourniquet was applied at the opposite site from operation thigh in the both groups. The thigh was covered with blanket to conceal the tourniquet inflation and deflation. A total of 3 cycles of tourniquet inflation for 5 minutes with 2 × systemic systolic arterial blood pressure of arrival at operation room and deflation were performed.
16056611|NCT02478203|Device|Airtraq|videolaryngoscope for difficult airway
16056778|NCT02477033|Other|Maltodextrin|
16056615|NCT02478190|Other|Loose control: goal glucose 600 mg/dL or lower|Goal glucose at discharge will be 600 mg/dL or less.
16056616|NCT02478164|Drug|Ponatinib|
16056617|NCT02478151|Device|OrganOx Metra|Normothermic machine perfusion (NMP) Metra device
16056618|NCT02478138|Procedure|Sentinel lymph node mapping|Thirty (30) patients will be enrolled under informed consent based upon their medical diagnosis, planned surgical procedures, and suitability for the procedure. During the study, patients will receive injections of ICG and will be imaged using a commercial NIR imaging system (Pinpoint, Novadaq, Waterloo ON). After the study, patients will continue with their planned management.
16056619|NCT02478138|Drug|Indocyanine Green (ICG)|
16056620|NCT02478138|Device|near-infrared fluorescence (NIR) imaging (Pinpoint, Novadaq, Waterloo)|
16056621|NCT02478125|Drug|Burixafor Hydrobromide|Investigators will determine the kinetics of PCa cell release into the blood with four daily dosages of Burixafor hydrobromide alone or in combination with G-CSF
16056622|NCT02478125|Drug|Docetaxel|Investigators will administer a single 75 mg/m2 IV dose of docetaxel. Twenty-one days later investigators will re-treat enrolled men with the optimal mobilization strategy + docetaxel IV. The second dose of docetaxel being given in combination with the optimal mobilization strategy will be chosen according to a standard 3+3 dose escalation schema, in which the dose of bruixafor +/- G-CSF will be held constant and the dose of docetaxel will escalate between three dose-levels: 1) docetaxel 30 mg/m2 IV, 2) docetaxel 60 mg/m2 IV, and 3) docetaxel 75 mg/m2
16056623|NCT02478125|Drug|G-CSF|G-CSF will be given as a daily subcutaneous (SC) injection beginning 4 days prior to Burixafor hydrobromide and continuing through the 4 days of Burixafor hydrobromide treatment
16056624|NCT02478112|Device|Biodegradable balloon implant|Implantation under general anaesthesia of a biodegradable balloon before radiation therapy for prostate cancer
16056625|NCT02478099|Drug|MPDL3280A|Anti-PD-L1 antibody
16056626|NCT02478086|Dietary Supplement|use amine acids parenteral 3.5g|"Group A we administered standard doses of amino acids was administered (3.5gr) the study of renal function baseline urea, creatinine and BUN were measured within 24 h after birth in order to avoid any alteration cost by mother alter kidney function, afterwards the same markers were measured at the day 7, 14, 21 and 28. These markers were measure using orto-clinical diagnostic series 50-0278 USA.
~The anthropometric measurements were assessed weekly by the same person to avoid bias (cephalic perimeter and height); weight was measured weekly using the same scale (SECA model 3741321009, Germany). All anthropometric and lab results were kept in a collection sheet."
16056627|NCT02478086|Dietary Supplement|use amine acids parenteral 4g|"Group B we administered high doses of amino acids was administered (4 gr) the study of renal function baseline urea, creatinine and BUN were measured within 24 h after birth in order to avoid any alteration cost by mother alter kidney function, afterwards the same markers were measured at the day 7, 14, 21 and 28. These markers were measure using orto-clinical diagnostic series 50-0278 USA.
~The anthropometric measurements were assessed weekly by the same person to avoid bias (cephalic perimeter and height); weight was measured weekly using the same scale (SECA model 3741321009, Germany). All anthropometric and lab results were kept in a collection sheet."
16056628|NCT02478060|Biological|Birch-SPIRE|
16056629|NCT02478060|Biological|Placebo|
16056630|NCT02478047|Drug|only antiemetic (Ramosetron, Tropisetron and dexamethasone)|The control group will receive standard antiemetic alone. Standard antiemetic for all groups is based on American Society of Clinical Oncology clinical practice guideline. 5-hydroxytryptamine-3 (5-HT3) antagonist (Ramosetron, Tropisetron) and dexamethasone are supplied from the first day of chemotherapy, and lasting for 3-5 days.And plus antiemetic drug as the comparator group.
16056631|NCT02478047|Other|Matching points ST36+CV12 plus antiemetic drug|"Choose both Zusanli(ST36) and Zhongwan point(CV12). Manipulating until achieving a de Qi sensation, then the needles are connected through a electro-acupuncture apparatus, the positive poles are linked to the needle, and the reference poles are located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA. The operation lasts for 30 min. The treatment is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.And plus antiemetic drug as the comparator group."
16056632|NCT02478047|Other|Matching points PC6+CV12 plus antiemetic drug|"Choose both Neiguan(PC6) and Zhongwan point(CV12). Manipulating until achieving a de Qi sensation, then the needles are connected through a electro-acupuncture apparatus, the positive poles are linked to the needle, and the reference poles are located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA. The operation lasts for 30 min. The treatment is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.And plus antiemetic drug as the comparator group."
16056633|NCT02478047|Other|Matching points CV13+CV12 plus antiemetic drug|"Choose both Shangwan(CV13) and Zhongwan point(CV12). Manipulating until achieving a de Qi sensation, then the needles are connected through a electro-acupuncture apparatus, the positive poles are linked to the needle, and the reference poles are located near the acupoint about 1cm with a paster. Frequency 10Hz,the intensity of stimulation is adjusted according to the patient's tolerance, and the electric current is less than 10mA. The operation lasts for 30 min. The treatment is scheduled to occur within 30min-60min before chemotherapy infusion for 4 days.And plus antiemetic drug as the comparator group."
16056634|NCT02478034|Other|Fludrocortisone|effects of fludrocortisone on cognition compared to placebo
16056635|NCT02478021|Other|Hydrocortisone|Effects of hydrocortisone compared to placebo on cognition
16056636|NCT02478008|Device|CardiAQ TMVI System (Transapical DS)|
16056637|NCT02477995|Biological|DTaP Vaccine A|Adsorption tetanus-diphtheria-acellular pertussis (DTaP) Vaccine A(Bejing minhai Biological Co., LTD) of 0.5ml, three doses, 28 days interval
16056638|NCT02477995|Biological|DTaP Vaccine B|Adsorption tetanus-diphtheria-acellular pertussis (DTaP) Vaccine B(Changchun changsheng Biological Co., LTD ) of 0.5ml in 600 infants aged 3-5months on day 0, 28, 56.
16056639|NCT02477969|Drug|PEX168(100µg)|PEX168,100µg,Subcutaneous injection,once a week. continued for 52 weeks
16056640|NCT02477969|Drug|PEX168(200µg)|PEX168,Subcutaneous injection,once a week. continued for 52 weeks
16056641|NCT02477969|Drug|Placebo|0.5ml,Subcutaneous injection,once a week.continued for 24 weeks,then followed by PEX168 100µg,qw sc. or 200µg qw sc.for 28 weeks.
16056642|NCT02477969|Drug|Metformin|0.5mg,oral,tid.
16056643|NCT02477956|Dietary Supplement|vitamin D3 (Replesta)|vitamin D group receive 2 replesta tablets (100,000 IU/month) of cholecalciferol.
16056644|NCT02477956|Dietary Supplement|vitamin D|
16056645|NCT02477943|Device|BrainScope Ahead 200iD|The BrainScope Battery evaluation will consist of 4 tests to aid in the assessment of concussion: History, Physical, signs and symptoms (SAC, SCAT3), Electrophysiological Function; Neurocognitive Performance Assessment and a balance/sway measurement. BrainScope Ahead 200iD device will be used to perform EEG.
16056646|NCT02477943|Device|Advanced MRI Neuroimaging|Diffusion tensor imaging (DTI) is a magnetic resonance imaging technique that enables the measurement of the restricted diffusion of water in tissue in order to produce neural tract images instead of using this data solely for the purpose of assigning contrast or colors to pixels in a cross sectional image.
16056647|NCT02477930|Other|No interventions are done|No intervention is done. This is a registry study.
16056648|NCT02477917|Biological|Allergovac depot with Parietaria judaica pollen extract|Subcutaneous immunotherapy in depot presentation in a rapid dose escalation scheme: 6 weekly dose increasing injections at the initiation phase plus 3 maintenance monthly injections
16056649|NCT02477904|Other|Ketogenic Diet|Dietary
16056650|NCT02477891|Drug|Daratumumab|Participants will receive daratumumab (16 milligram per kilogram [mg/kg]) as intravenous infusion on Day 1, 8, 15, and 22 of Cycles 1 and 2 (weekly dosing), on Day 1 and 15 of Cycles 3 to 6 (every 2 weeks dosing), and on Day 1 of Cycle 7 and subsequent cycles (every 4 weeks dosing) until documented progression, unacceptable toxicity, or study end. Each cycle is of 28 days.
16056651|NCT02477878|Biological|BPX-501|Biological: T cells transduced with CaspaCIDe suicide gene
16056652|NCT02477878|Drug|Rimiducid|Rimiducid administered to treat GVHD
16056653|NCT02477865|Drug|PEX168(100µg)|100µg,Subcutaneous injection,once a week. continued for 52 weeks
16056654|NCT02477865|Drug|PEX168(200µg)|200µg,Subcutaneous injection,once a week. continued for 52 weeks
16056655|NCT02477865|Drug|Placebo|0.5ml,Subcutaneous injection,once a week.continued for 24 weeks,then use PEX168 100µg or 200µg qw sc.for 28 weeks.
16056656|NCT02477852|Drug|Isoniazid|preoperative treatment of spinal tuberculosis with Isoniazid
16056657|NCT02477852|Drug|Rifampicin|preoperative treatment of spinal tuberculosis with Rifampicin
16056658|NCT02477852|Drug|Ethambutol|preoperative treatment of spinal tuberculosis with Ethambutol
16056659|NCT02477852|Drug|Pyrazinamide|preoperative treatment of spinal tuberculosis with Pyrazinamide
16056660|NCT02477839|Drug|Lacosamide|Active Substance: Lacosamide Pharmaceutical Form: Syrup Concentration: 10 mg/mL Route of Administration: oral
16056661|NCT02477839|Other|Placebo|Active Substance: Placebo Pharmaceutical Form: Syrup Concentration: N/A Route of Administration: oral
16056662|NCT02477826|Drug|Nivolumab|
16056663|NCT02477826|Drug|Ipilimumab|
16056664|NCT02477826|Drug|Carboplatin|
16056665|NCT02477826|Drug|Cisplatin|
16056666|NCT02477826|Drug|Gemcitabine|
16056667|NCT02477826|Drug|Pemetrexed|
16056668|NCT02477826|Drug|Paclitaxel|
16056669|NCT02477813|Drug|Temozolomide|200 mg/m2 die for 5 consecutive days every 28 days. Treatment will be continued until tumor progression, intolerable toxicity or patient refusal
16056670|NCT02477800|Drug|Aducanumab (BIIB037)|Low dose
16056671|NCT02477800|Drug|Aducanumab (BIIB037)|High dose
16056672|NCT02477800|Drug|Placebo|Placebo
16056673|NCT02477787|Biological|allogeneic, donor-derived NK cells|"Patients in the study arm will receive donor NK cell infusion around days 13 and 20. A permissible range of infusion time will be +/- 3 days.
~For DNKI to be given on day 13 (DNKI-1), the cell dose is 1-2 x108/kg or about the half of amount generated. For DNKI to be given on day 20 (DNKI-2), the cell dose is up to 5x108/kg.
~Avil 1 ampoule will be given intravenously 30 minutes prior to each NK cell infusions."
16056674|NCT02477774|Device|ARISTA|According to the manufacturer, Arista uses Microporous Polysaccharide Hemospheres (MPH) technology to catalyze the clotting cascade and effectively dehydrate tissue to initiate hemostasis in broad areas. Major advantages of Arista are that it has been shown to be safe and effective across multiple surgical disciplines, is completely absorbed in 24-48 hours, and contains no human or animal components
16056675|NCT02477761|Dietary Supplement|Nutrient preload|Ingestion of a small mixed protein and lipid meal 30 minutes before glucose
16056676|NCT02477748|Drug|MDX|Immediate-release/slow-release,bilayer tablet PO of 1400 mg, taken once daily for 10 weeks.
16056677|NCT02477748|Drug|Placebo|Tablet PO, taken once daily for 10 weeks.
16056678|NCT02477735|Device|Actigraphy|Actigraphy will be conducted for each participant for 7 consecutive nights prior to TTI and for 7 consecutive nights 4-6 weeks following TTI.
16056679|NCT02477722|Other|EFP-NF|
16056680|NCT02477722|Other|Sham|
16056681|NCT02477709|Drug|Gefapixant|Gefapixant oral tablet (150 mg administered as three 50 mg tablets) - single dose only
16056682|NCT02477696|Drug|ACP-196|acalabrutinib 100 mg BID (Arm A; N=250)
16056683|NCT02477696|Drug|ibrutinib|ibrutinib 420 mg QD (Arm B; N=250)
16056684|NCT02477670|Drug|AVP-786|
16056685|NCT02477670|Drug|Placebo|
16056686|NCT02477657|Procedure|Paracentesis|Paracentesis
16056687|NCT02477657|Device|Tunneled Intraperitoneal Drain (IPD)|Tunneled Intraperitoneal Drain (IPD)
16056688|NCT02477657|Device|Peritoneal-Venous shunts (PVS)|Peritoneal-Venous shunts (PVS)
16056689|NCT02477644|Drug|Olaparib|Tablets, per os, 300 mg twice daily;
16056690|NCT02477644|Drug|Placebo|Tablets, per os, 300 mg twice daily.
16056691|NCT02477631|Drug|Deferiprone|This is a single-arm, open-label, multi-center study in 20 patients with MDS. All participants will be treated with deferiprone for up to 4 months.
16056692|NCT02477618|Drug|SAGE-547|
16056693|NCT02477618|Drug|Placebo|Placebo
16056694|NCT02477605|Device|CONSTELLATION® 27-gauge Combined Surgical Pak|Sterile single-use supplies necessary to perform 1 vitrectomy surgery: 1 ULTRAVIT® 27-gauge 7500 cuts per minute (cpm) vitrectomy probe and a 27-gauge EDGEPLUS® Valved Entry System comprised of 3 trocar/cannulas and related accessories.
16056695|NCT02477605|Device|CONSTELLATION® 23-gauge Combined Surgical Pak|Sterile single-use supplies necessary to perform 1 vitrectomy surgery: 1 ULTRAVIT® 23-gauge 7500 cuts per minute (cpm) vitrectomy probe and a 23-gauge EDGEPLUS® trocar/cannula set comprising of 3 trocars/cannulas and related accessories.
16056696|NCT02477605|Procedure|Vitrectomy surgery|Microincisional pars plana vitrectomy (PPV) surgery for the treatment of various vitreoretinal diseases ranging from simple to advanced cases
16056697|NCT02477592|Procedure|individualized substrate modification|CPVI ablation and left atrial roof linear ablation first,then substrate mapping in sinus rhythm followed by individualized substrate modification.
16056698|NCT02477592|Procedure|stepwise ablation|CPVI ablation,left atrial roof linear ablation,mitral isthmus linear ablation,complex fractionated atrial electrograms ablation step by step.
16056699|NCT02477579|Device|NovaCross|The NovaCross™ is a guidewire positioning and support microcatheter for improving chronic total occlusion (CTO) crossability. The NovaCross™ gains its supportive characteristics through the use of a unique operator-controlled Nitinol scaffold and an extendable segment, both at its distal tip.
16056700|NCT02477566|Drug|Long-acting Triptorelin|Pituitary down-regulation with Long-acting Triptorelin 1.875mg during the luteal phase
16056701|NCT02477566|Drug|Short-acting Triptorelin|Pituitary down-regulation with Short-acting Triptorelin 0.1mg/d,x10d, then 0.05mg/d until E2<40pg/ml in serum, was initiated during the luteal phase
16056702|NCT02477553|Behavioral|DA - Quantitative|
16056703|NCT02477553|Behavioral|DA - Verbal|
16056704|NCT02477540|Drug|Cellgram-CLI|"Appearance: White cell suspension is filled in a clear plastic syringe, and fixed with an occlude on the prefilled syringe tip
~Main ingredient: Autologous bone marrow-derived mesenchymal stem cells
~Dosage: 50,000,000 cells/10ml, 2-time injection
~Storage: An airtight container, 20~25℃
~Injection Method: Intramuscular"
16056705|NCT02477527|Drug|Stribild|Change subjects from Atripla one tablet per day to elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil one tablet per day.
16056706|NCT02477514|Drug|midazolam|2 mg (1 mL of 2 mg/mL oral syrup) administered as a single dose on Days 1 and 14
16056707|NCT02477514|Drug|rosuvastatin|10 mg tablet administered as a single oral dose on Days 3 and 16
16056708|NCT02477514|Drug|tedizolid phosphate|200 mg oral tablet administered once daily on Days 5-17
16056709|NCT02477501|Drug|Norepinephrine|continuous infusion
16056710|NCT02477501|Drug|Ephedrine|continuous infusion
16056711|NCT02477488|Drug|Allopurinol|Administration of allopurinol is changed to bedtime (hs) for each patient, at the same dosage as was previously prescribed.
16056712|NCT02477462|Other|Clinic visit|Blood draw every 3 months; quality of life surveys and imaging annually
16056713|NCT02477462|Other|Baseline visit|Blood draw and quality of life surveys
16056714|NCT02477449|Drug|istaroxime|8 subjects in 0.25ug/kg/min group were administrated Istaroxime + 0.9% NS fo12 subjects in 0.5ug/kg/min or 1.0 ug/kg/min group randomly received Istaroxime placebo + 0.9% NS (2 subjects), 0.9% NS alone (2 subjects) and Istaroxime + 0.9% NS (8 subjects).
16056715|NCT02477449|Drug|9% Saline (NS)|infusion for 24 hours
16056716|NCT02477436|Drug|Avanafil|"One capsule should be taken with water, 30 minutes before sexual intercourse. It should be taken only once a day.
~Intemperance in eating and drinking should not be done, 2 hours before and 2 hour after taking the investigational product.
~Investigational products were administered prior to the sexual intercourse for total 8 weeks."
16056717|NCT02477436|Drug|Placebo|"One capsule should be taken with water, 30 minutes before sexual intercourse. It should be taken only once a day.
~Intemperance in eating and drinking should not be done, 2 hours before and 2 hour after taking the placebo.
~Placebos were administered prior to the sexual intercourse for total 8 weeks."
16056718|NCT02477423|Drug|Ampicillin|Ampicillin will be given as routine antibiotic coverage for those in the active arm, as the standard initial antibiotic used within the neonatal unit. It may also be used for patients who are not eligible for randomization.
16056719|NCT02477423|Drug|Gentamicins|Gentamicin will be given as routine antibiotic coverage for those in the active arm, as the standard initial antibiotic used within the neonatal unit. It may also be used for patients who are not eligible for randomization.
16056720|NCT02477423|Drug|Placebo|Normal saline will be given as placebo for those in the placebo comparator group.
16056721|NCT02477410|Dietary Supplement|Hydrolysed porcine protein from blood|Effects of hydrolysed porcine proteins on muscle protein synthesis and appetite
16056722|NCT02477410|Dietary Supplement|Hydrolysed porcine protein from muscle|Effects of hydrolysed porcine proteins on muscle protein synthesis and appetite
16056723|NCT02477410|Dietary Supplement|Hydrolysed whey protein|Effects of hydrolysed porcine proteins on muscle protein synthesis and appetite
16056724|NCT02477397|Drug|Spiromax Budesonide/formoterol|1. In Group A, Patients will be treated with Spiromax® budesonide/formoterol 160/4.5 μg two inhalations twice daily + Spiromax® budesonide/formoterol 160/4.5 μg as needed with a maximum of 8 additional inhalations daily.
16056725|NCT02477397|Drug|Diskus Fluticasone/salmeterol|2. In group B, Patients will be treated with Diskus® fluticasone/salmeterol 500/50 μg one inhalation twice daily + salbutamol 100 μg as needed with a maximum of 8 inhalations daily.
16056726|NCT02477384|Procedure|8mm-TIPS|
16056727|NCT02477384|Procedure|Endoscopic variceal ligation|
16056728|NCT02477384|Drug|Propranolol|
16056729|NCT02477384|Device|8mm ePTFE-covered stent|
16056730|NCT02477371|Procedure|Fractional flow reserve-guided CABG|Coronary arteries with angiographical significant stenoses, that are planned for grafting at the heart team meeting and where FFR-measurements are made, only receive grafting if FFR-value is ≤ 0,8. Arteries with FFR-values > 0,8 are deferred.
16056731|NCT02477371|Procedure|Angiography-guided CABG|Coronary arteries with angiographical significant stenoses, that are planned for grafting at the heart team meeting all receive grafting. FFR-measurements are still made, but not used for guidance of grafting.
16056779|NCT02477020|Drug|TAK-063 20 mg|TAK-063 tablet.
16056780|NCT02477020|Drug|Placebo|TAK-063 matching-placebo tablet.
16056781|NCT02477007|Drug|Paracetamol|Paracetamol will be an oral solution of 30 mg/ml. The doses of paracetamol will be 15 mg/kg (maximum dose: 1g).
16058493|NCT02465112|Other|simple monitoring without active therapy|
16056734|NCT02477345|Drug|Omegaven IV|"Omegaven will be initiated at a dose of 0.5 gram/Kg/day and is infused over 24 hours for 1-2 days, and then advanced to
~1 gram/Kg/day. Omegaven will be infused intravenously through either a central or peripheral catheter alone or in conjunction with parenteral nutrition. Omegaven will continue until weaned from PN. Monotherapy with Omegaven can continue as an additional source of calories after the dextrose/protein portion of PN is discontinued. Omegaven may be restarted within seven days of discontinuing therapy. After seven days, and meeting inclusion criteria, Omegaven can resume at the initial dose of 0.5 grams/Kg/day, advancing to 1 gm/kg/day."
16056735|NCT02477332|Biological|QGE031|
16056736|NCT02477332|Biological|Omalizumab|
16056737|NCT02477332|Other|Placebo|
16056738|NCT02477319|Other|Observational|
16056739|NCT02477306|Drug|Idiazole 20mg DR tabs|Delayed release tablets containing 20 mg of rabeprazole
16056740|NCT02477306|Drug|PARIET 20 mg DR tabs|Orally administered, delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium.
16056741|NCT02477293|Drug|Hyeonggaeyeongyo-tang|
16056742|NCT02477280|Drug|Methylphenidate|Cross-over
16056743|NCT02477280|Drug|Placebo|Medikinet
16056744|NCT02477267|Drug|SL spray|
16056745|NCT02477267|Drug|SL film|
16056746|NCT02477254|Biological|Vaccination|A quadrivalent HPV vaccine
16056747|NCT02477241|Procedure|Uroflowmetry|A cystometric test measures how much urine the bladder can hold, how much pressure builds up inside the bladder as it stores urine, and how full it is when the urge to urinate begins. Uroflowmetry is the measurement of urine speed and volume.
16056748|NCT02477241|Device|fMRI|Functional magnetic resonance imaging or functional MRI (fMRI) is a functional neuroimaging procedure using MRI technology that measures brain activity by detecting associated changes in blood flow. This technique relies on the fact that cerebral blood flow and neuronal activation are coupled. When an area of the brain is in use, blood flow to that region also increases.
16056749|NCT02477228|Procedure|conventional ERCP|ERCP was done through the papilla. duration of cannulation, number of trials for cannulation, number of pancreatic cannulation, bleeding during cannulation and its management, need to convert to the other approach in cannulation.
16056750|NCT02477228|Procedure|Precut ERCP|ERCP was done through precut from the start duration of cannulation, number of trials for cannulation, number of pancreatic cannulation, bleeding during cannulation and its management, need to convert to the other approach in cannulation.
16056751|NCT02477215|Drug|MLN9708|4 mg of MLN9708 delivered on days 1, 8 and 15 of a 28 day cycle.
16056752|NCT02477215|Drug|Dexamethasone|40 mg oral on Days 1, 8, 15 of each 28 day cycle.
16056753|NCT02477215|Drug|Bendamustine (multiple dose levels)|70 mg/m^2, 80 mg/m^2, or 90 mg/m^2 on days 1 and 2
16056754|NCT02477215|Drug|Bendamustine (MTD)|80 mg/m^2 on days 1 and 2
16056755|NCT02477202|Device|Mirena® intra-uterine device (IUD)|In this study, a Mirena® IUD will be inserted into volunteers scheduled for a risk-reducing salpingo-oophorectomy (RRSO) or risk-reducing salpingectomy (RRS) at Memorial Sloan Kettering Cancer Center (MSK). Alternatively, women with a Mirena® IUD already in place and who will be scheduled for an RRSO or RRS at MSK can also participate. We are seeking 14 evaluable participants. FTF tissue (and ovarian inclusion cyst tissue, when available) collected at the time of risk-reducing salpingectomy (RRS) will be tested by immunochemistry staining for Ki67 (a protein that is significantly increased when cells are preparing for division).
16056756|NCT02477189|Procedure|Silicone Block|
16056757|NCT02477176|Other|Discectomy|Lumbar discectomy
16056758|NCT02477150|Biological|Zostavax|Vaccination of a zoster vaccine (Zostavax)
16056759|NCT02477150|Biological|placebo|placebo administration
16056760|NCT02477137|Device|smartphone or tablet|Patients in the intervention group are given access to an application for a smartphone/tablet for daily reporting of symptoms, access to self-care advice and health-care professionals in real time.
16056761|NCT02477124|Device|transvaginal digital colposcope (TVDC)|TVDC is a miniature colposcope used to obtain images of cervical tissue.
16056762|NCT02477124|Other|Standard of care screening|Standard of care screening varies from institution to institution but is either visual inspection with the naked eye, colposcopy, or visual inspection with a camera or microscope
16056763|NCT02477111|Device|Endovascular abdominal aortic aneurysm repair|Subjects with infrarenal abdominal aortic aneurysms who meet all inclusion criteria and none of the exclusion criteria will be treated with the INCRAFT Stent Graft System.
16056764|NCT02477098|Drug|preoperative 0.5% ropivacaine hydrochloride preoperative|Before surgery (Pre RSB) , a bilateral RSB with ropivacaine hydrochloride will be performed under ultrasound guidance by one anaesthesiologist.At the end of surgery, a bilateral RSB with saline will be performed under ultrasound guidance by one anaesthesiologist.
16056765|NCT02477098|Drug|postoperative 0.5% Ropivacaine hydrochloride|Before surgery, a bilateral RSB with saline will be performed under ultrasound guidance by one anaesthesiologist.At the end of surgery, a bilateral RSB with ropivacaine hydrochloride will be performed under ultrasound guidance by one anaesthesiologist.
16056766|NCT02477085|Other|all women with an induced labor|all women who have an induced labor
16056767|NCT02477072|Procedure|ACT|Blood samples for ACT will be collected following induction of anesthesia, 30 minutes after heparin administration, and on arrival in the recovery room.
16056768|NCT02477072|Procedure|TEG|Blood samples for TEG will be collected following induction of anesthesia, 30 minutes after heparin administration, and on arrival in the recovery room.
16056769|NCT02477072|Procedure|Ankle-brachial index|Peripheral blood flow will be assessed prior and after surgery using the ankle-brachial and toe-brachial indexes.
16056770|NCT02477072|Procedure|Toe-brachial index|Peripheral blood flow will be assessed prior and after surgery using the ankle-brachial and toe-brachial indexes.
16056771|NCT02477072|Drug|Heparin|Heparin doses will be administered according to the assigned group.
16056772|NCT02477059|Drug|tocilizumab|Le tocilizumab is administered by intravenous infusion at a dose of 8 mg / kg.
16056773|NCT02477059|Drug|saline solution|La saline solution is administered by intravenous infusion.
16056774|NCT02477046|Biological|tOPV|administered per protocol
16056775|NCT02477046|Biological|bOPV|administered per protocol
16056776|NCT02477046|Biological|IPV|administered per protocol
16056777|NCT02477033|Dietary Supplement|Butyricicoccus pullicaecorum 25-3T|
16056782|NCT02477007|Drug|Ibuprofen|Ibuprofen will be an oral suspension of 20mg/ml. The doses of ibuprofen 10 mg/kg (maximum dose: 400 mg).
16056783|NCT02477007|Drug|paracetamol + ibuprofen|Paracetamol will be an oral solution of 30 mg/ml. The doses of paracetamol will be 15 mg/kg (maximum dose: 1g) Ibuprofen will be an oral suspension of 20mg/ml. The doses of ibuprofen 10 mg/kg (maximum dose: 400 mg).
16056784|NCT02477007|Drug|Placebo|Placebo will have the closest flavour, smell and aspect to the active substances, respectively paracetamol and ibuprofen. Placebo will be prepared in bottles with a fake label of active substances for a better blinding both for the nurse and the patient. Labels will be hiding by a mask.
16056785|NCT02476994|Drug|Clinolipid|
16056786|NCT02476994|Drug|Intralipid|Standard-of-Care Soybean Oil-Based Lipid Emulsion
16056787|NCT02476981|Drug|Remifentanil|Patients given remifentanil received continuous infusion of the drug at 1-5 µg/kg/h
16056788|NCT02476981|Drug|Dexmedetomidine|Patients receiving dexmedetomidine were given that drug at 0.3-0.4 µg/kg over 10 min, followed by continuous infusion of 0.2 1 µg/kg/h
16056789|NCT02476981|Drug|midazolam|All patients were premedicated with midazolam 0.02 mg/kg before induction.
16056790|NCT02476981|Drug|propofol|All patients in both groups received a bolus dose of propofol 0.3 mg/kg for sedative effect.
16056791|NCT02476981|Drug|ephedrine|Ephedrine 5 mg was injected when systolic blood pressure decreased below 90 mmHg
16056792|NCT02476968|Drug|Olaparib|"Olaparib Capsule - 50 mg. Olaparib capsules will be packed in high-density polyethylene (HDPE) bottles with child-resistant closures. Each bottle will contain 120 capsules and 4 bottles will be dispensed for a 4 weekly visit, with a 2 day overage.
~Patients will be administered olaparib capsules orally at a dose of 400 mg twice daily.
~Eight 50 mg olaparib capsules should be taken at the same time each day approximately 12 hours apart with approximately 240 mL of water."
16056793|NCT02476955|Drug|ARQ 092 + carboplatin + paclitaxel (Closed)|Subjects will receive ARQ 092 orally at dose levels specified for their respective dose cohorts plus carboplatin (AUC6, intravenously, Day 1) plus paclitaxel (175 mg/m2, intravenously, Day 1) on a 21-day schedule.
16056794|NCT02476955|Drug|ARQ 092 + paclitaxel (Closed)|ARQ 092 will be administered orally at 200 mg twice a day (BID) weekly (Cohort 1P) of a 28-day cycle in combination with an intravenous (IV) infusion of paclitaxel (80 mg/m2). ARQ 092 will be administered once a week on Day 1, Day 8, Day 15, and Day 22 of each 28-day cycle; paclitaxel will be administered once a week on Day 1, Day 8, and Day 15 for three consecutive weeks followed by one week off of each 28-day cycle.
16056795|NCT02476955|Drug|ARQ 092 + anastrozole|ARQ 092 will be administered orally at 150 mg QD, 5 days on/9 days of a 28 day cycle in combination with anastrozole which will be administered orally at 1 mg QD continuously.
16056796|NCT02476942|Drug|Bypassing Agents|Episodic or prophylactic treatment with the use of bypassing agents must be documented for at least the last 6 months prior to the study. During the study, treatment for bleeds will be documented. The choice of coagulation product is at the discretion of the investigator according to local practice standards in this non-interventional study and there are no specific protocol-defined interventions.
16056797|NCT02476942|Drug|FVIII Replacement|Episodic or prophylactic treatment with the use of FVIII replacement must be documented for at least the last 6 months prior to the study. During the study, treatment for bleeds will be documented. The choice of coagulation product is at the discretion of the investigator according to local practice standards in this non-interventional study and there are no specific protocol-defined interventions.
16056798|NCT02476929|Device|Nasal nitrous oxide|Electrochemical device (NOVario Analizer FILT), to determine reference values of Nasal nitrous oxide.
16056799|NCT02476929|Device|Electronic nose|To determine reference values of different patterns of specific volatile organic compounds with the electronic nose (Cyranose 320®).
16056800|NCT02476916|Drug|AG-348|Participants with PK deficiency were randomized to either receive AG-348, 50 or 300 mg, as initial doses, BID for the Core Period (Week 24). At the Week 24 visit, Core Period participants who had safely tolerated AG-348 and demonstrated clinical activity in response to AG-348 were potentially eligible to immediately roll over to the Extension Period for continued treatment. Participants were assigned to initial doses, however, over the course of the core period were treated across a range of doses due to treatment emergent adverse events (AEs) and hemoglobin (Hb) levels exceeding mid-point of sex-adjusted ranges.
16056801|NCT02476903|Drug|Monovisc|
16056802|NCT02476890|Drug|Gefapixant 100 mg|Gefapixant 100 mg (2 x 50 mg tablets), administered orally as a single dose in treatment Period 1 or treatment Period 2
16056803|NCT02476890|Drug|Placebo|Placebo (two tablets matching gefapixant 50 mg), administered orally as a single dose in treatment Period 1 or treatment Period 2
16056804|NCT02476864|Drug|Treatment A (adult formulation)|Single oral administration of one film-coated tablet containing 10 mg of macitentan as active substance and lactose, magnesium stearate, microcrystalline cellulose, povidone, sodium starch glycolate type A, polysorbate as inactive ingredients.The film coat contains titanium dioxide, talc, xanthan gum, polyvinyl alcohol, and soy lecithin.
16056805|NCT02476864|Drug|Treatment B (pediatric formulation)|Single oral administration of two dispersible tablets, each containing 5 mg of macitentan as active ingredient and Mannitol delta polymorphic crystals, mannitol, isomalt, isomalt agglomerated, croscarmellose sodium, and magnesium stearate as inactive ingredients.
16056806|NCT02476851|Device|POLFA (Needle Assembly)|Each subject receives the same intervention and blood is drawn into both the INA and CNA. The difference is the order in which the CNA or INA is applied.
16056807|NCT02476851|Device|Kawasumi (Needle Assembly)|Each subject receives the same intervention and blood is drawn into both the INA and CNA. The difference is the order in which the CNA or INA is applied.
16056808|NCT02476838|Procedure|Hand Transplantation|microvascular VCA transplant
16056809|NCT02476825|Drug|Fluticasone propionate|Flixotide Accuhaler 500 micrograms b.i.d.
16056810|NCT02476825|Device|Accuhaler|Flixotide Accuhaler 500 micrograms b.i.d.
16056811|NCT02476812|Behavioral|Positive Piggy Bank|Already noted.
16056812|NCT02476799|Procedure|Rectus sheath block|Ultrasound-guided bilateral rectus sheath block of RSB group using 0.25% Ropivacaine
16056813|NCT02476799|Drug|Ropivacaine|Ultrasound-guided bilateral rectus sheath block of RSB group using 0.25% Ropivacaine
16056814|NCT02476799|Other|Bandage|After the surgery, a bandage will be attached on injection site where is same as the incision site of surgery.
16060152|NCT02453516|Drug|ropivacaine|Drug indicated for regional anesthesia
16056815|NCT02476799|Drug|IV-PCA containing Fentanyl and Ketorolac|All patients will use total 100 ml of IV-PCA containing 800 µg of fentanyl and 150 mg of ketorolac for 48 hours postoperatively.
16056816|NCT02476786|Behavioral|FACT-B|The FACT-B (Version 4) is a 37-item measure that contains the four general subscales along with the Breast Cancer-Specific subscale that assesses symptoms/concerns of particular relevance to breast cancer (e.g., body image, arm swelling and tenderness).
16056817|NCT02476786|Drug|Goserelin|
16056818|NCT02476786|Drug|Anastrozole|
16056819|NCT02476786|Drug|Exemestane|
16056820|NCT02476786|Drug|Fulvestrant|
16056821|NCT02476786|Drug|Tamoxifen|
16056822|NCT02476786|Other|Archived tissue collection|
16056823|NCT02476773|Biological|Na-GST-1/Alhydrogel plus GLA-AF|
16056824|NCT02476773|Biological|Na-APR-1 (M74)/Alhydrogel|
16056825|NCT02476773|Biological|Na-APR-1 (M74)/Alhydrogel plus GLA-AF|
16056826|NCT02476773|Biological|Sterile Saline Placebo|
16056827|NCT02476760|Drug|DPP-4 inhibitors|Current exposure to DPP-4 inhibitors (ATC A10BH, A10BD07-A10BD13) will be defined as a prescription duration plus a 30-day grace period (to account for non-adherence and the biological half-lives of these drugs) that overlaps with the index day.
16056828|NCT02476760|Drug|GLP-1 analogs|Current exposure to GLP-1 analogs (ATC A10BX04, A10BX07) will be defined as a prescription duration plus a 30-day grace
16056829|NCT02476760|Drug|Insulins|Current exposure to insulin (ATC A10A) will be defined as any use of insulin between base cohort entry and the index day.
16056830|NCT02476760|Drug|Biguanides|Current exposure to biguanides (ATC A10BA) will be defined as a prescription duration plus a 30-day grace period (to account for non-adherence and the biological half-lives of these drugs) that overlaps with the index day.
16056831|NCT02476760|Drug|Sulfonylureas|Current exposure to sulfonylureas (ATC A10BB or A10BC) will be defined as a prescription duration plus a 30-day grace period (to account for non-adherence and the biological half-lives of these drugs) that overlaps with the index day.
16056832|NCT02476760|Drug|Thiazolidinediones|Current exposure to thiazolidinediones (ATC A10BG) will be defined as a prescription duration plus a 30-day grace period (to account for non-adherence and the biological half-lives of these drugs) that overlaps with the index day.
16056833|NCT02476760|Drug|Alpha-glucosidase inhibitors|Current exposure to alpha-glucosidase inhibitors (ATC A10BF) will be defined as a prescription duration plus a 30-day grace period (to account for non-adherence and the biological half-lives of these drugs) that overlaps with the index day.
16056834|NCT02476760|Drug|Meglitinides|Current exposure to meglitinides (ATC A10BX02, A10BX03) will be defined as a prescription duration plus a 30-day grace period (to account for non-adherence and the biological half-lives of these drugs) that overlaps with the index (event) day.
16056835|NCT02476747|Other|EMR|performing EMR for patients with small polyp
16056836|NCT02476747|Other|CSP|performing CSP for patients with small polyp
16056837|NCT02476734|Other|There is no intervention|Subjects undergo FDG-PET CT scans in order to determine lesional FDG intake and changes in lesional FDG uptake.
16056838|NCT02476721|Other|detection of pulmonary embolism|
16056839|NCT02476708|Dietary Supplement|curcumin 1800mg|Curcumin, derived from turmeric root, is an over-the-counter supplement which is tolerated well.
16056840|NCT02476708|Dietary Supplement|Placebo|oral placebo capsule
16056841|NCT02476695|Device|FibroTouch Examination|Liver stiffness measurements are performed using FibroTouch and the procedure is non-invasive and painless.
16056842|NCT02476695|Device|FibroScan Examination|Liver stiffness measurements are performed using another transient elastography, FibroScan, and the procedure is non-invasive and painless.
16056843|NCT02476695|Device|Ultrasonic B Examination|The ultrasonic B examination is made at an empty stomach for ≥8h. The inner diameter of liver, spleen, gallbladder, portal vein and splenoportal vein is measured through the ordinary two-dimensional ultrasonic examination. The echo data of liver surface/edge/parenchyma and gallbladder wall is scored to evaluate the severity of fibrosis.
16056844|NCT02476682|Other|blood or stool samples will be collected|blood or stool samples will be collected
16056845|NCT02476643|Other|Integrative Therapy|This group receives an integrative therapy at the Department of Internal and Integrative Medicine, i.e. a combination of conventional diagnostic and therapeutic interventions with specific naturopathic, and complementary medicine approaches, and physical therapy.
16056846|NCT02476630|Device|StO2 measurement|All participants will have a measurement of the tissue oxygen concentration (StO2) level after applying the noninvasive probe to the thenar eminence. This measurement is done at the same time as a blood gas from the central venous catheter is obtained. The StO2 measurement is documented once for the subject in the study.
16056847|NCT02476630|Other|Blood Gases|All participants will have a measurement of the tissue oxygen concentration (StO2) level after applying the noninvasive probe to the thenar eminence. This measurement is done at the same time as a blood gas from the central venous catheter is obtained. The StO2 measurement is documented once for the subject in the study.
16056848|NCT02476617|Drug|ombitasvir/paritaprevir/ritonavir|ombitasvir/ABT-450/ritonavir tablets
16056849|NCT02476617|Drug|dasabuvir|dasabuvir tablets
16056850|NCT02476617|Drug|ribavirin|ribavirin tablets
16056851|NCT02476604|Behavioral|health coaching and electronic messaging|Using using an iPAD or notebook PC, students will receive electronic messaging aimed at encouraging adherence to behavioral goals previously set via discussions with the health coaches. The messages will be received 3 to 6 times per week for the 8 week intervention period.
16056852|NCT02476591|Behavioral|Charge Transparency|"Providers caring for patients in the Charge Transparency cohort will be given access to patient specific charge data on a daily basis via an interactive dashboard which allows for full charge transparency to patients admitted to the Vanderbilt ICUs"
16056853|NCT02476578|Other|Email|Automated Email to the primary doctor and nurse, with the details of the patient, the condition found and the relevant measures to consider.
16056854|NCT02476565|Device|LMA-Supreme supraglottic device|The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway.
16060627|NCT02450292|Procedure|Bioabsorbable screw fixation|
16056855|NCT02476565|Device|I-gel supraglottic device|The fiberscope (with the Aintree loaded on top of it) will be advanced through the supraglottic device into the trachea. Next, the supraglottic device will be removed and the endotracheal tube will be advanced into the airway over the Aintree airway intubation catheter. Finally, the Aintree catheter is removed and the endotracheal tube will be left in the airway.
16056856|NCT02476552|Drug|Niraparib Oral Capsules (Labeled)|Single 300 mg dose of niraparib
16056857|NCT02476552|Drug|Niraparib IV (Labeled)|Intravenous (IV) infusion of 100 μg niraparib (containing approximately 1 μCi of [14C]-niraparib)
16056858|NCT02476552|Drug|Niraparib Oral Capsules (Unlabeled)|Single 300 mg dose of niraparib (unlabeled active pharmaceutical ingredient)
16056859|NCT02476539|Drug|Hemay022|
16056860|NCT02476526|Drug|Low Volume iso-osmolar non-ionic radio contrast medium|Intravenous injection of low volume (30 cc) iso-osmolar non-ionic radio contrast medium as part of the 64-MDCT Scanning procedure (intervention group only)
16056861|NCT02476526|Drug|Acetylcysteine Inhalation|Mucomyst 1200 mg po BID x 48 hours starting the day prior to the CT scan (both experimental and control groups)
16056862|NCT02476526|Drug|Sodium Bicarbonate Solution|Isotonic Sodium Bicarbonate 3 ml/kg/hr iv for 1 hour prior to the CT scan and for 6 hours after the CT scan (both experimental and control groups)
16056863|NCT02476526|Procedure|64-MDCT Scanning|Both experimental and control groups will undergo 64-MDCT scanning over the thoracic area
16056864|NCT02476500|Procedure|LLETZ on a training model|LLETZ is performed on a sausage-based training model using all surgical devices used in the original procedure
16056865|NCT02476487|Procedure|FDG PET CT|"FDG-PET CT will be performed on day 7-14 since the first positive blood culture. 1. Patients fulfilling current criteria for a short course (2 weeks) of antibiotic treatment: treatment will be prolonged if PET CT demonstrates a focus of residual infection.
~2. Patients with risk factors mandating prolonged antibiotic treatment (4-6 weeks) according to current guidelines without IE: antibiotics will be stopped at 2 weeks if PET CT is normal."
16056866|NCT02476474|Procedure|3 cm start of resection|Investigators will start the resection of the LSG 3 centimeters from the antrum of the stomach.
16056867|NCT02476474|Procedure|6 cm start of resection|Investigators will start the resection of the LSG 6 centimeters from the antrum of the stomach.
16056868|NCT02476461|Drug|xiapex|
16056869|NCT02476461|Procedure|percutaneous needle fasciotomy|
16056870|NCT02476448|Drug|Normal saline|Used to distend the bladder for cystoscopic evaluation
16056871|NCT02476448|Drug|Phenazopyridine|Administered orally preoperatively and assessed during cystoscopy
16056872|NCT02476448|Drug|Dextrose 10%|Used to distend the bladder for cystoscopic evaluation
16056873|NCT02476448|Drug|Sodium Fluorescein|Administered intravenously and assessed during cystoscopy
16056874|NCT02476435|Device|Active rTMS|Strong electromagnetic fields (~2Tesla) generated briefly but repetitively (1Hz) applied for 30mins, in five sessions per week for 3 weeks
16056875|NCT02476435|Device|Placebo rTMS|Placebo electromagnetic fields generated briefly but repetitively applied for 30mins, in five sessions per week for 3 weeks
16056876|NCT02476422|Drug|Diclofenac potassium|Single dose of diclofenac 50 mg soft gelatin capsule
16056877|NCT02476422|Drug|Ibuprofen|Single dose of ibuprofen 400 mg tablet
16056878|NCT02476422|Drug|Placebo to ibuprofen|Single dose of placebo to ibuprofen 400 mg tablet
16056879|NCT02476422|Drug|Placebo to diclofenac potassium|Single dose of placebo to diclofenac potassium 50 mg soft gelatin capsule
16056880|NCT02476409|Drug|tolvaptan|Study will test the addition of tolvaptan to augmentation of loop diuretic as standard of care for outpatients presenting with worsening heart failure.
16056881|NCT02476409|Other|Placebo|Placebo for tolvaptan
16056882|NCT02476396|Procedure|Carotid Endarterectomy|"Carotid endarterectomy is a procedure to treat carotid artery disease. This disease occurs when fatty, waxy deposits build up in one of the carotid arteries. The carotid arteries are blood vessels located on each side of your neck (carotid arteries).
~This buildup of plaques (atherosclerosis) may restrict blood flow to your brain. Removing plaques causing the narrowing in the artery can improve blood flow in your carotid artery and reduce your risk of stroke.
~In carotid endarterectomy, you an anesthetic. Your surgeon makes an incision along the front of your neck, opens your carotid artery and removes the plaques that are clogging your artery. Your surgeon then repairs the artery with stitches or a patch made with a vein or artificial material (patch graft).
~Source: Mayo Clinic"
16056883|NCT02476383|Procedure|spinal manipulative therapy|refer to arm descriptions
16056884|NCT02476370|Behavioral|relaxation program|"relaxation and mindfulness techniques such as body scan, breathing meditation or imagination exercises
~1 week programm, one introductory session and daily home practice"
16056885|NCT02476370|Behavioral|surgery education|"intensified education unit to reduce anxiety and stress, by using pictures and videos of rooms, and procedures of the planned surgery
~1 single unit in the week before the surgery"
16056886|NCT02476357|Device|Harmonic scalpel|
16056887|NCT02476344|Other|experiment protocol|"each subject will perform the following 3 days experiment protocol, consisting of army training exercises:
~sack carrying exercise.
~crawling exercise.
~combined exercise: sack carrying, crawling and sprints.
~heart rate, core temperature, lactic acid and CPK levels will be monitored continuously."
16056888|NCT02476331|Behavioral|Working memory training|The neurocognitive training program will be provided by an online platform called BrainGymmer (https://www.braingymmer.com/en/brain-games/). The experimental group will complete the working memory training, which involves three games: N-back, Multi-Memory, and Moving Memory. These games are designed to engage processes involving updating and manipulation of information. All of the training games provided by BrainGymmer are adaptive, meaning that the level of difficulty increases as users develop expertise on a given task. Participants randomized to the cognitive training arm will complete the training games for 30 minutes per day, 5 days a week, for a total of 10 weeks.
16056889|NCT02476318|Device|ArterX Vascular Sealant|
16056890|NCT02476305|Device|"cryoprobes"|Patient undergo percutaneous cryoablation of desmoid tumor, with cryoprobes
16056891|NCT02476292|Other|online questionnaire|The online questionnaire includes questions about vasculitis, employment and work status before diagnosis and over the course of the disease, work capacity and the financial impact of vasculitis.
16056892|NCT02476279|Other|Indomethacin 100 mg rectally immediately after ERCP, NO prophylactic pancreatic stent placement|
16056893|NCT02476279|Other|Indomethacin 100 mg rectally immediately after ERCP AND prophylactic pancreatic stent placement|
16056894|NCT02476266|Other|Resistance Training|Resistance training has been shown to improve balance and muscle weakness in those with PD as well as reducing the number of falls experienced, albeit not significantly. However to date no study has investigated forms of resistance training in the same study. To disentangle which form of resistance training might be more effective at reducing the risk of falls, improving balance and muscle strength, the proposed study will compare power training and conventional strength training.
16056895|NCT02476253|Drug|Sodium Bicarbonate|Intravenous 4.2% Sodium Bicarbonate 125ml to 250ml / 30min up to 1000ml/24h to maintain plasma pH equal or greater than 7.30
16056896|NCT02476240|Behavioral|Parkinson's disease Sensory Attention Focused Exercise|The first half of the exercise class will include walking exercises that include large magnitude and coordinated movements. All walking will be performed slowly. Walking exercises will be followed by balance, stretching, and coordination exercises while sitting in, or standing near, standard office chairs, utilizing latex Thera-bands®. To ensure that balance and coordination are constantly challenged throughout the intervention, the exercise program progresses each week, increasing in difficulty. Depending on the task, the first set of each exercise will be performed with 'eyes-open' to familiarize participants with the task, and subsequent sets will be performed with 'eyes-closed'. If there is only one set for a specific exercise, the first half of the repetitions will be performed with 'eyes-open' and the second half with 'eyes-closed'.
16056897|NCT02476227|Procedure|Ablation using CARTO system|automated algorithm (Visitag)-based vs. manual collection of RF ablation points during AF ablation
16056898|NCT02476214|Behavioral|group prenatal care|"Intervention group Groups of 8-12 women who are in similar week of pregnancy / due date. The first group session will begin at 12-14 week (depends on gestational age at first OBGYN visit). The group meetings will be held once a month until 28 weeks of pregnancy. From 28 weeks and until the end of pregnancy or 40 weeks, it will be held once every two weeks (according to the Ministry of Health guidelines). The last session will be held approximately 6 weeks after birth.
~There will be about 10 group sessions. Each session will be around 90 minutes. At the beginning of every group meeting, the nurse will preform a short anamnesis and measures in private, followed by discussion and guidance. At the end of the session, if needed, women can have private time with the nurse."
16056899|NCT02476201|Device|MPP ON|Patients implanted with a Cardiac Resynchronization Therapy CRT-D device and a Quartet Left Ventricular (LV) quadripolar lead and with the MultiPoint Pacing (MPP) feature activated
16056900|NCT02476188|Procedure|Sample of Blood|
16056901|NCT02476175|Drug|Mirabegron|Patients will keep the antimuscarinic providing some efficacy and that is tolerated and Mirabegron will be added (dual therapy).
16056902|NCT02476162|Device|iHealth Wireless Blood Pressure Monitor|"Participants will be provided with an iHealth Wireless Blood Pressure (BP) Monitor and instructions for proper use (based on a standard protocol). The iHealth device pairs easily with a cell phone or other mobile device equipped with the iHealth app (freely available on app stores for both Apple and Android devices). Participants place the cuff on their arm and press start on their mobile device. The device measures BP using the oscillometric method and automatically downloads measurements and timing to a cloud-based server.
~Participants will be educated that individual BP readings can be highly variable and that any one high or low reading has little or no significance. They will also be encouraged not to measure their blood pressure more than twice in the morning and twice in the evening."
16056903|NCT02476149|Procedure|Corneal Cross-linking|All participants recruited for the study will be scheduled for corneal crosslinking treatment
16056904|NCT02476136|Drug|paroxetine, duloxetine, fluoxetine or venlafaxine|
16056905|NCT02476123|Biological|Mogamulizumab: KW-0761, Nivolumab: (ONO-4538/BMS-936558)|i.v. administration
16056906|NCT02476110|Dietary Supplement|Oral nutritive supplements|
16056907|NCT02476097|Drug|Esomeprazole: Nexium® 20mg, Astra Zeneca|Comparison of the prevalence of clinical symptoms of acid rebound, between patients with progressive (esomeprazole ) or sudden (placebo) discontinuation of Proton pump inhibitors.
16056908|NCT02476097|Other|CYP2C19 phenotypical analysis|All patients included will undergo an assessment of the CYP2C19 activity by the administration of omeprazole 40mg and following measurement of omeprazole metabolic ratio respectively, once during the study.
16056909|NCT02476097|Drug|Placebo|Comparison of the prevalence of clinical symptoms of acid rebound, between patients with progressive (esomeprazole ) or sudden (placebo) discontinuation of Proton pump inhibitors.
16056910|NCT02476084|Other|Musculoskeletal Ultrasound Imaging|B-mode and PD musculoskeletal ultrasound examination of selected joints.
16056911|NCT02476084|Other|Synovial biopsy|US guided synovial biopsy of an inflamed joint including wrists, MCP joints and knees.
16056912|NCT02476084|Other|Biological samples collection|Draw of research blood samples.
16056913|NCT02476084|Other|Questionnaires|Administration of validated patients' questionnaires.
16056914|NCT02476071|Other|Mass media|Mass media (MM): Radio broadcasts, dramatized dialogues, interviews with opinion leaders and satisfied clients . Posters.
16056915|NCT02476071|Other|Stylish Man (SMEvent)|"Stylish Man Events: community mobilization via music, contests, testimonials from satisfied VMC adopters. Messages on how VMC, in conjunction with other HIV prevention, can make men feel more in control of their lives, less stressed, and more Stylish are interwoven through the mobilization.
~The Stylish Man Van (SMV) accompanies the SMEvent. The Van includes multimedia and health mobilizers who insert HIV prevention messages."
16056916|NCT02476058|Drug|JNJ-42847922|JNJ-428479, 20 milligram (mg) capsule, orally, once daily, at bedtime for 10 days in women of childbearing potential (WOCBP) or for 4 weeks in all other participants.
16056917|NCT02476058|Drug|Diphenhydramine|Diphenhydramine 25 mg capsule, orally, once daily, at bedtime for 10 days in women of childbearing potential (WOCBP) or for 4 weeks in all other participants.
16056918|NCT02476058|Drug|Placebo|Matching placebo (capsules containing neutral pellets), orally, once daily, at bedtime for 10 days in women of childbearing potential (WOCBP) or for 4 weeks in all other participants.
16056919|NCT02476045|Drug|5-fluorouracil,leucovorin,panitumumab|Maintenance treatment (ARM A)
16056920|NCT02476045|Drug|panitumumab|Maintenance treatment (ARM B)
16056921|NCT02476045|Drug|Oxaliplatin, 5-fluorouracil,leucovorin,panitumumab|Induction treatment
16057076|NCT02475044|Behavioral|Cognitive-Behavioral Therapy|16 Sessions of CBT.
16056922|NCT02476032|Device|Prof applied oxalate|Crest Sensi-Stop strips (Procter & Gamble™) with the active ingredient will be placed on the qualifying teeth by a dental professional.
16056923|NCT02476032|Device|Self applied oxalate|Subjects will apply the strips (Procter & Gamble™), that contain the active ingredient, by themselves following the manufacturer's instructions.
16056924|NCT02476032|Device|Prof applied placebo|Crest Sensi-Stop strips (Procter & Gamble™) without the active ingredient will be placed on the qualifying teeth by a dental professional.
16056925|NCT02476019|Drug|ISIS-FGFR4RX|ISIS-FGFR4RX administered subcutaneously
16056926|NCT02476019|Drug|Placebo|Placebo administered subcutaneously
16056927|NCT02476006|Drug|ALIROCUMAB SAR236553 (REGN727)|Pharmaceutical form:solution Route of administration: subcutaneous
16056928|NCT02476006|Drug|placebo (for injection training only)|Pharmaceutical form:solution Route of administration: subcutaneous
16056929|NCT02476006|Drug|ezetimibe|Pharmaceutical form:capsule Route of administration: oral
16056930|NCT02476006|Drug|atorvastatin|Pharmaceutical form:tablet Route of administration: oral
16056931|NCT02476006|Drug|rosuvastatin|Pharmaceutical form:tablet Route of administration: oral
16056932|NCT02476006|Drug|simvastatin|Pharmaceutical form:tablet Route of administration: oral
16056933|NCT02475993|Other|SMART app|Subjects assigned to the intervention group will be given the pre-programmed SMART app on an iPad mini loaned to you for use during the study along with the medication plan as outlined in the discharge instructions and an appointment within 12 days. This will include SCD-related medications. Subjects will be asked to log entries each time they take their medications and will be reminded by SMART to take their medications based on their advised schedule. Follow up appointment time and date are also programmed into SMART, and reminders are given to the subject 3 days prior and on the day of appointment. Compliance will also be confirmed by pill count of all medications at the 30-day visit.
16056934|NCT02475980|Behavioral|Comprehensive contraception counseling|The study intervention will consist of comprehensive contraceptive counseling through a standardized bundle of services, including a 10-minute educational DVD, handouts on contraceptive methods, and one-on-one contraceptive counseling by the PED physician.
16056935|NCT02475967|Other|Intervention group|The intervention group patients have access to the eLearning platform in addition to conventional cardiac care.The content of platform will be gathered from a multidisciplinary input of both medics (e.g. cardiologists) and paramedics (e.g. psychologists). Patients will also contribute to platform content.
16056936|NCT02475967|Other|Control group|The control group patients receive conventional cardiac care alone.
16056937|NCT02475954|Behavioral|TH-CBT|The TH-CBT group will receive the study intervention and standard care. The study treatment has been previously manualized and modified for remote administration, as described in the introduction to the revised application.12 PD Veterans will receive 10 weekly individual sessions (60 minutes each) of CBT, delivered via Video-to-Home (V2H).
16056938|NCT02475954|Other|Standard Care|Standard Care is defined as medical and psychiatric treatment provided by patients' personal doctors (e.g., neurologists, psychiatrists, therapists). Veterans will continue to receive routine clinical care and will remain on all depression treatments that they were receiving prior to their study (e.g., stable anti-depressant medications, established psychotherapy, clinical monitoring).
16056939|NCT02475941|Other|Non Weight bearing|"The design will be a surgeon based prospective cohort supported in the literature to answer research questions in which surgeons may have a preferred treatment type. Each surgeon will treat study subjects by his or her single chosen method (weight bearing as tolerated post operatively versus non weight bearing).
~The benefits of early weight bearing are accelerated functional recovery, increased independence, decreased impact on the family, increased psychological benefits, reduced use of healthcare resources, decreased need for family intervention, and family to take care of the patient."
16056940|NCT02475941|Other|Early Weight Bearing|"The design will be a surgeon based prospective cohort supported in the literature to answer research questions in which surgeons may have a preferred treatment type. Each surgeon will treat study subjects by his or her single chosen method (weight bearing as tolerated post operatively versus non weight bearing).
~The benefits of early weight bearing are accelerated functional recovery, increased independence, decreased impact on the family, increased psychological benefits, reduced use of healthcare resources, decreased need for family intervention, and family to take care of the patient."
16056941|NCT02475928|Dietary Supplement|zinc gluconate|Zinc supplementation plus nutritional education
16056942|NCT02475928|Dietary Supplement|Placebo|
16056943|NCT02475928|Behavioral|Nutritional education|
16056944|NCT02475915|Drug|Vorinostat|Vorinostat (suberoylanilide hydroxamic acid) inhibits histone deacetylases class I and II. Vorinostat is supplied as 100mg capsules and will be administered at 400mg/ day in 2 week cycles beginning at week 0 for 10 weeks - 42 doses.
16056945|NCT02475915|Drug|Hydroxychloroquine|Hydroxychloroquine is supplied as 200mg tablets and will be administered at week 0 for 10 weeks
16056946|NCT02475915|Drug|Maraviroc|Maraviroc will be administered at 150 to 600mg/ml twice daily depending on the subject's ART regimen at week 0 for 10 weeks
16056947|NCT02475915|Drug|Tenofovir|NRTI. Tenofovir will be administered at 300mg 1 X day at week 0 for 10 weeks
16056948|NCT02475915|Drug|Emtricitabine|NRTI. Emtricitabine will be administered at 200mg 1 X day at week 0 for 10 weeks
16056949|NCT02475915|Drug|Efavirenz|NNRTI. Efavirenz will be administered at 600 mg 1 X day at week 0 for 10 weeks
16056950|NCT02475915|Drug|Darunavir|Protease Inhibitor. Darunavir will be administered at a dose of 900mg 1 X day for subjects on NNRTI based ART beginning at week 8 until week 10
16056951|NCT02475902|Behavioral|Computer guided home exercise program|Participants will follow a computerized fall prevention home exercise program with MS Kinect camera tracking 3 times per week for one month.
16056952|NCT02475902|Behavioral|Paper guided home exercise program|Participants will follow a fall prevention home exercise program outlined in a paper booklet 3 times per week for one month.
16056953|NCT02475889|Procedure|Hepatic RFA|Hepatic RFA was performed under guidace of ultrasonography (US) or computed tomography (CT) before primary tumor resection.
16056954|NCT02475889|Procedure|Primary tumor resection|Primary tumor resection were performed pre- or post-RFA for liver metastases.
16057251|NCT02473705|Dietary Supplement|Fish Oil Placebo and Bicarbonate|Fish oil placebo (soybean oil) and 1mg of bicarbonate per Kg of body weight per day
16056955|NCT02475876|Drug|Clindamycin|"Route of administration is IV for all Cohorts. Dosing interval is every 8 hrs. for all Cohorts:
~Cohort 1; No. Subjects = 5; Age 1-5 months; Dose = 9 mg/kg;
~Cohort 2; No. Subjects = 5; Age >5 months to 1 year; Dose =12 mg/kg;
~Cohort 3; No. Subjects = 5; Age >1-2 years; Dose =12 mg/kg.
~Cohort 4; No. Subjects = 4; Age >2-6 years; Dose =12 mg/kg.
~Cohort 5; No. Subjects = 4; Age >6-12 years; Dose =10 mg/kg.
~Cohort 6; No. Subjects = 4; Age >12-16 years; Dose =10 mg/kg."
16056956|NCT02475876|Drug|trimethoprim-sulfamethoxazole|"Route of administration is PO for all Cohorts. Dosing interval is every 12 hrs. for all Cohorts:
~Cohort 1; No. Subjects = 5; Age 1-5 months; Dose = 6 mg/kg.
~Cohort 2; No. Subjects = 5; Age >5 months to 1 year; Dose = 6 mg/kg.
~Cohort 3; No. Subjects = 5; Age >1-2 years; Dose = 6 mg/kg.
~Cohort 4; No. Subjects = 4; Age >2-6 years; Dose = 6 mg/kg.
~Cohort 5; No. Subjects = 4; Age >6-12 years; Dose = 6 mg/kg.
~Cohort 6; No. Subjects = 4; Age >12-16 years; Dose = 4 mg/kg."
16056957|NCT02475863|Device|Warfarin Dosing Aid|A pharmacokinetic/pharmacodynamic model-based dosing algorithm for warfarin
16056958|NCT02475863|Other|Standard Practice|Warfarin dose adjustments according to standard unit protocol
16056959|NCT02475850|Other|Evidence-based tailored fall prevention|
16056960|NCT02475850|Other|Usual care|
16056961|NCT02475837|Drug|Vorapaxar sulfate|The study drug (12-week supply of study drug) will be dispensed to enrolled patients on the first day following surgery.
16056962|NCT02475837|Drug|Placebo|The placebo will match the study drug, vorapaxar sulfate, in appearance. A 12-week supply will be dispensed to enrolled patients on the first day following surgery.
16056963|NCT02475824|Drug|Midazolam®|midazolam (0.05 mg/kg, 30% reduction for patients if age ≥70 or ASA class III-IV; Bukwang Pharm Co., Seoul, Republic of Korea)
16056964|NCT02475824|Drug|"Meperidine (pethidine®)"|Meperidine (50mg. 25mg for patients aged ≥70 years; pethidine HCL, Hana Pharm Co., Seoul, Republic of Korea).
16056965|NCT02475824|Drug|Propofol®|Repeated doses of 10-20 mg propofol are titrated to achieve the target level of sedation.
16056966|NCT02475824|Drug|Dexmedetomidine (Precedex®)|Dexmedetomidine (1μg/kg/h, Precedex; Hospira, Seoul, Republic of Korea) or the same volume of normal saline were administered in the MMD and midazolam-meperidine group
16056967|NCT02475811|Radiation|3D ultrasonography|The angle of volume sampling varied throughout gestational age with a maximum limit of 75° in the third trimester. After scanning the volume, multiplanar imaging in the 3 orthogonal ultrasonographic sections was analyzed to reconstruct the 3D ultrasound image. Before its volume was analyzed, each lung was carefully identified on the 3 orthogonal multiplanar imaging sections. We used the rotational technique that entails the VOCAL imaging program to measure lung volume. A transverse section of the multiplanar imaging was chosen as the reference image for volume analyses
16056968|NCT02475798|Device|Zenith® Branch Endovascular Graft-Iliac Bifurcation,|Implantation of the following devices: Zenith® Branch Endovascular Graft-Iliac Bifurcation, the Atrium iCAST™, and the Zenith® Flex AAA Endovascular Graft.
16056969|NCT02475785|Device|FFRD and mini plates group|FFRD direct loading over mini plates inserted in the mandibular symphysis
16056970|NCT02475785|Device|Conventional FFRD|FFRD inserted between maxillary and mandibular arches with the pushrods placed distal to mandibular canines
16056971|NCT02475772|Drug|Cisplatin and doxorubicin|The first 5 patients will receive doxorubicin 1.5 mg/m2 body surface in 50 ml NaCl 0,9% and cisplatin 7.5 mg/m2 in 50 ml NaCl 0,9% q 4 weeks for three courses. The next 5 patients will receive doxorubicin 2.25 mg/m2 body surface in 50 ml NaCl 0,9% and cisplatin 11.25 mg/m2 in 50 ml NaCl 0,9% q 4 weeks for three courses. The next 5 patients will receive doxorubicin 3 mg/m2 body surface in 50 ml NaCl 0,9% and cisplatin 15 mg/m2 in 50 ml NaCl 0,9% q 4 weeks for three courses. This schedule represents a three-step, 50% dose-escalation. Dose density will not be changed.
16056972|NCT02475772|Procedure|Cisplatin and doxorubicin|intraperitoneal chemotherapy with cisplatin and doxorubicin in a dose-escalation scheme
16056973|NCT02475759|Dietary Supplement|optimal caloric intake for two weeks|nutritional intervention received two weeks before surgical intervention
16056974|NCT02475759|Dietary Supplement|optimal caloric intake for one week|nutritional intervention received one weeks before surgical intervention
16056975|NCT02475746|Drug|PF-06372865|single dose of 7.5 mg PF-06372865 alone (period 1) or co-administered with itraconazole (period 2)
16056976|NCT02475746|Drug|itraconazole|Interacting drug which will be given 200 mg QD for 8 days in period 2
16056977|NCT02475733|Drug|Ceftazidime -avibactam|Randomisation (3:1) to ceftazidime -avibactam plus metronidazole or meropenem treatment
16056978|NCT02475733|Drug|Meropenem|Randomisation (3:1) to CAZ AVI plus metronidazole or meropenem treatment
16056979|NCT02475733|Drug|Metronidazole|Randomisation (3:1) to ceftazidime -avibactam plus metronidazole or meropenem treatment
16056980|NCT02475707|Biological|MultiTAA-specific T cells|"The 3 dose levels are:
~Dose Level 1: 5 x 10e6 cells/m2; Dose Level 2: 1 x 10e7 cells/m2; Dose Level 3: 2 x 10e7 cells/m2
~The T cells are given from 30 days post-HSCT. They are administered by intravenous injection over 1-10 minutes through either a peripheral or a central line.
~Patients being treated on Arm A (adjuvant) or Arm B (active disease) who have a partial response, complete response or stable disease, will be eligible to receive up to 6 further doses of multiTAA-specific T cells at the same dose as the initial infusions at a minimum of 4 weeks apart."
16056981|NCT02475694|Other|No intervention|No treatment
16056982|NCT02475681|Drug|Acalabrutinib|
16056983|NCT02475681|Drug|Obinutuzumab|
16056984|NCT02475681|Drug|Chlorambucil|
16056985|NCT02475668|Device|Pulse oximeter|Hypoxia
16056986|NCT02475655|Drug|Ruxolitinib|10 mg orally twice daily for 5 weeks
16056987|NCT02475642|Other|PVI-ADT|Discontinue antiarrhythmic drugs at randomisation (3 months post ablation). As per the eligibility criteria, all patients randomised are taking either Flecainide, Cibenzoline, Propafenon, Sotalol or Amiodarone. These are discontinued at the moment of randomisation in this arm
16056988|NCT02475642|Other|PVI+ADT|Discontinue antiarrhythmic drugs 9 months after randomisation (12 months post ablation). As per the eligibility criteria, all patients randomised are taking either Flecainide, Cibenzoline, Propafenon, Sotalol or Amiodarone. These are continued in this arm until 9 months post randomisation at which point they are stopped
16056989|NCT02475629|Biological|ibalizumab|2000mg intravenous ibalizumab (loading dose), followed 14 days later by 800mg intravenous ibalizumab every 2 weeks
16057321|NCT02473263|Drug|Ceftriaxone|Ceftriaxone 2g IV will be infused in the first 60 minutes, for non nosocomial severe septic syndrome
16056990|NCT02475629|Drug|Optimized Background Regimen (OBR)|All participants will be prescribed an Optimized Background Regimen of antiretroviral medications selected on the basis of treatment history and the results of Screening viral resistance and tropism testing. The prescribed regimen must contain at least one agent to which the participant's virus is known to be sensitive.
16056991|NCT02475616|Drug|PCO371|
16056992|NCT02475616|Drug|Placebo|
16056993|NCT02475603|Procedure|Total knee arthroplasty|Total knee arthroplasty
16056994|NCT02475590|Procedure|Laparoscopic sleeve gastrectomy|Laparoscopic sleeve gastrectomy
16056995|NCT02475590|Procedure|Laparoscopic Roux-en-Y gastric bypass|Laparoscopic Roux-en-Y gastric bypass
16056996|NCT02475577|Device|Peripherals with HealthInterlink technology|home remote monitoring
16056997|NCT02475564|Drug|Placebo|40mg of starch
16056998|NCT02475564|Drug|Resveratrol|40mg of resveratrol (powder)
16056999|NCT02475551|Drug|IdeS|Intravenous infusion
16057000|NCT02475538|Device|Electroacupuncture|"Gradual Tapering Benzodiazepines will be tapered off over four weeks. The subjects will be told by a blinded researcher to reduce their daily dose by 25% in the 1st and 2nd week. For the remaining 50%, subjects will be asked to reduce the dose by 12.5% each time for 3-4 days in the 3rd and 4th week. Subjects who are unable to taper according to the suggested plan can reduce dose at a slower pace.
~Electroacupuncture The subjects will be treated with electroacupuncture at bilateral Sishencong (EX-HN1), Anmian, Shuaigu (GB8), Touwei (ST8), Taiyang (EX-HN5), Toulinqi (GB15), Neiguan (PC6), Shenmen (HT7), Sanyinjiao (SP6), Taichong (LV3), and unilateral Yintang (EX-HN3), Shenting (GV24), and Baihui (GV20). De qi is achieved if possible. The intensity of electric-stimulation will be adjusted up to a level the subject can tolerate without undue discomfort. The needles will be left for 30 min."
16057001|NCT02475538|Device|Placebo acupuncture|"Gradual Tapering The gradual tapering procedure will be the same as in the Electroacupuncture combined with gradual tapering group.
~Placebo acupuncture Placebo needles designed by Streitberger will be used. The placebo needles are inserted to the site 1 inch beside the acupoints of the electroacupuncture group in order to avoid acupressure effect. The needles are held by surgical tape or hair pin to imitate the procedure of acupuncture. The needles are connected to an electric-stimulator with zero frequency and amplitude. The number, duration and frequency of treatment session will be the same as in the Electroacupuncture combined with gradual tapering group."
16057002|NCT02475525|Dietary Supplement|Arginine enriched oral nutritional supplement|oral nutritional supplement containing arginine
16057003|NCT02475512|Other|Wash wipes (3M)|
16057004|NCT02475512|Other|water and pH neutral soap|
16057005|NCT02475499|Drug|DPP-4 inhibitors|Ever-use of DPP-4 inhibitors (ATC A10BH, A10BD07-A10BD13) will be defined as a prescription occurring between (and including) base cohort entry and the index day - 365 days.
16057006|NCT02475499|Drug|GLP-1 analogs|Ever-use of GLP-1 analogs (ATC A10BX04, A10BX07) will be defined as a prescription occurring between (and including) base cohort entry and the index day - 365 days.
16057007|NCT02475499|Drug|Sulfonylureas|Ever-use of sulfonylureas (ATC A10BB or A10BC) will be defined as a prescription occurring between (and including) base cohort entry and the index day - 365 days.
16057008|NCT02475499|Drug|Biguanides|Ever-use of biguanides (ATC A10BA) will be defined as a prescription occurring between (and including) base cohort entry and the index day - 365 days.
16057009|NCT02475499|Drug|Thiazolidinediones|Ever-use of thiazolidinediones (ATC A10BG) will be defined as a prescription occurring between (and including) base cohort entry and the index day - 365 days.
16057010|NCT02475499|Drug|Alpha-glucosidase inhibitors|Ever-use of alpha-glucosidase inhibitors (ATC A10BF) will be defined as a prescription occurring between (and including) base cohort entry and the index day - 365 days.
16057011|NCT02475499|Drug|Meglitinides|Ever-use of meglitinides (ATC A10BX02, A10BX03) will be defined as a prescription occurring between (and including) base cohort entry and the index day - 365 days.
16057012|NCT02475486|Device|VistaO2|ANS (sympathetic nervous system) parameters are measured by VistaO2 device in RA patients
16057013|NCT02475473|Other|Exercise Training|Chronic High-Intensity Resistance Training
16057014|NCT02475460|Procedure|Less Invasive Surgery (LIS)|Less invasive HM 3 LVAD surgical implant procedure
16057015|NCT02475460|Device|HeartMate 3™|HM 3 LIS
16057016|NCT02475447|Drug|Asimadoline|kappa-opioid receptor agonist
16057017|NCT02475447|Drug|Placebo|placebo-matched control
16057018|NCT02475434|Dietary Supplement|Cream Supplement group|Infants in the intervention arm will receive the cream supplement in addition to the standard regimen.
16057019|NCT02475421|Biological|Glucagon|One hour glucagon-clamp followed by one hour of blood sampling
16057020|NCT02475408|Device|Amplatzer vascular plug|
16057021|NCT02475395|Device|TRAK device|Use of TRAK to attain sperm concentration measurement
16057022|NCT02475382|Drug|Nivolumab|Specified dose on specified days
16057023|NCT02475369|Drug|pancrelipase|
16057024|NCT02475356|Drug|Levonorgestrel IUS (Mirena, BAY86-5028)|The treatment of Mirena should comply with the local product information.
16057025|NCT02475343|Device|Schiotz tonometer|The corneal biomechanical properties will be measured using a Schiotz tonometer with routine manipulation protocol.This measurement will be used in normal people, keratoconic patients, patients received keratoplasty.
16057026|NCT02475343|Device|UVA/riboflavin|The UVA/riboflavin corneal crosslinking will be applied using a UV-X lamp (Peschke Meditrade GmbH, Switzerland) with routine manipulation protocol (3mW/cm2, 365nm, 30 minutes).This treatment will be used in keratoconic patients.
16057027|NCT02475343|Device|femto-LASIK|The keratoplasty mainly include femto-LASIK (Laser in situ keratomileusis), which will be applied using a Wavelight FS200 and Wavelight EX500 Excimer Laser (Alcon Inc. USA.).The keratoplasty will be applied in patients who would like to receive the surgery.
16057028|NCT02475343|Device|Tomey SP-100 Pchymeter , Topolyzer Vario|Cornea thickness will be measured with a pachymeter (Tomey SP-100 Pchymeter, Japan); cornea topography will be measured with Topolyzer Vario (Allegro, Wavelight GmBH, Germany); anterior chamber depth, white to white, and ocular axis length will be measured using a IOL master (Carl Zeiss Meditec, Germany). These measurements will be used in normal people, keratoconic patients, patients received keratoplasty.
16057252|NCT02473705|Dietary Supplement|Fish Oil Placebo and Bicarbonate Placebo|Fish oil placebo (soybean oil) and bicarbonate placebo (Methylcellulose)
16057029|NCT02475343|Device|Topcon CT-80, Topcon, Japan|Vision acuity will be measured with a decimal visual chart; IOP (Intra-ocular pressure) will be measured with a tonometer (Topcon CT-80, Topcon, Japan) , fundoscopy examination will be apllied with a direct ophthalmoscopy, slit lamp examination will be applied with a slit lamp. These examinations will be used in normal people, keratoconic patients, patients received keratoplasty.
16057030|NCT02475343|Device|Corvis-ST|Cornea biomechanical properties will be measured with a ocular response analyzer (Reichert, USA.) and/or a Corvis-ST (Oculus, Germany).These measurements will be used in normal people, keratoconic patients, patients received keratoplasty.
16057031|NCT02475330|Dietary Supplement|Flaxseed|Whole grain flaxseed diet consisting of 40g flaxseed ingested per day
16057032|NCT02475317|Drug|Placebo|Participants will receive placebo matched to maralixibat/volixibat orally for 7 days.
16057033|NCT02475317|Drug|Maralixibat|Participants will receive maralixibat in 10 mg, 20 mg, 50 mg or 100 mg doses.
16057034|NCT02475317|Drug|Volixibat|Participants will receive volixibat in 10 mg and 20 mg doses.
16057035|NCT02475304|Drug|FP187|FP 187 is given as oral tablets twice daily, 500 mg daily
16057036|NCT02475304|Drug|Placebo|
16057037|NCT02475278|Biological|NoV GI.1/GII.4 Bivalent VLP Vaccine|Norovirus GI.1/GII.4 bivalent VLP vaccine adjuvanted with aluminum hydroxide for IM injection
16057038|NCT02475265|Drug|estradiol 0.045 mg/levonorgestrel 0.015mg|
16057039|NCT02475252|Procedure|hysteroscopy on a training model|Diagnostic hysteroscopy on a diagnostic hysteroscopy training model using a pelvic dummy and all surgical instruments also used in the original procedure. The performance of all participants will be scored using an OSATS scoring sheet developed for assessing surgical proficiency.
16057040|NCT02475239|Behavioral|Postural restriction|The patients were instructed to avoid head movements, wear a soft collar during the daytime, wear a supporting pillow and sleep in the semi-upright position at a 45 degree head elevation from the horizontal plane during the nighttime for 48 hours.
16057041|NCT02475239|Behavioral|Normal daily activity|The patients did not follow any postural restrictions and were asked to live as normally as possible.
16057042|NCT02475226|Other|type of the brain injury|epidural hematoma
16057043|NCT02475226|Other|type of the brain injury|subdural hematoma
16057044|NCT02475226|Other|type of the brain injury|subarachnoid hematoma
16057045|NCT02475226|Other|type of the brain injury|intraparenchymal hematoma
16057046|NCT02475226|Other|type of the brain injury|scull fracture
16057047|NCT02475226|Other|type of the brain injury|brain contusion
16057048|NCT02475213|Biological|Enoblituzumab|enoblituzumab is administered by IV infusion once per week for up to 51 doses.
16057049|NCT02475213|Biological|Pembrolizumab|Pembrolizumab is administered by IV infusion every 3 weeks for up to 17 doses.
16057050|NCT02475213|Biological|MGA012|anti-PD-1 monoclonal antibody
16057051|NCT02475200|Device|Atherectomy|Selectively cut and remove atheromatous plaque in the lower extremities. Debulking and removal of atherosclerotic burden plaque with Phoenix Atherectomy System.
16057052|NCT02475174|Other|Without upper limb elevation|Lymphatic drainage without elevation of the upper limb.
16057053|NCT02475174|Other|Upper limb elevation to 30º|Lymphatic drainage with elevation of the upper limb to 30º.
16057054|NCT02475161|Drug|JNJ-42847922|JNJ-42847922 will be administered as 20 mg tablet orally.
16057055|NCT02475161|Drug|Rabeprazole|Rabeprazole will be administered as 20 mg tablet orally.
16057056|NCT02475148|Drug|JNJ 54175446|
16057057|NCT02475148|Drug|Placebo|
16057058|NCT02475148|Other|High fat/high Calorie Breakfast|
16057059|NCT02475135|Drug|Darunavir/Cobicistat/Emtricitabine/Tenofovir alafenamide FDC|A tablet containing DRV 800 mg, COBI 150 mg, FTC 200 mg and TAF 10 mg as FDC will be administered.
16057060|NCT02475135|Drug|Elvitegravir /Cobicistat/Emtricitabine/Tenofovir alafenamide FDC|A tablet containing EVG 150 mg, COBI 150 mg, FTC 200 mg and TAF 10 mg as FDC will be administered.
16057061|NCT02475135|Drug|Darunavir|A tablet containing Darunavir (DRV) 800 mg will be administered.
16057062|NCT02475135|Drug|Emtricitabine/Tenofovir alafenamide (FTC/TAF)|A tablet containing Emtricitabine (FTC) 200 mg and Tenofovir alafenamide (TAF) 10 mg will be administered.
16057063|NCT02475135|Drug|Cobicistat|A tablet containing cobicistat (COBI) 150 mg will be administered.
16057064|NCT02475135|Other|High-fat Breakfast|High-fat breakfast will be administered.
16057065|NCT02475135|Other|Standardized Regular Breakfast|Standardized regular breakfast will administered.
16057066|NCT02475122|Other|azygos blood flow measurements by MRI|
16057067|NCT02475109|Drug|PAN-90806 Ophthalmic Solution|
16057068|NCT02475096|Behavioral|Internet-delivered CBT|"The treatment is based on an internet-delivered CBT-treatment for adults with IBS and on the adapted version for adolescents with functional gastrointestinal disorders. The protocol has been tested in an open face-to-face CBT study of children aged 8-12 years (n=20) with promising results.
~Main component in the treatment is exposure for symptoms. The purpose of the treatment is to reduce fearful and anxious responses to symptoms and lessen avoidance of symptoms in the child, and to teach the parents how parental behavior can influence symptoms in children as well as how to support exposure. Detailed behaviour analysis is made for each individual and instruction is given on how to gradually expose to symptoms to lessen fear for symptoms and widen the behavioral repertoire."
16057069|NCT02475083|Other|Virtual Reality|Rehabilitation with virtual reality, using Football games, Boxe, Bambolê and Tennis.
16057070|NCT02475083|Other|Conventional|Stretching exercises in limbs, trunk mobilization in the three planes, balance training in standing position, training of balance reactions and gait training.
16057071|NCT02475070|Drug|Vildagliptin|Vildagliptin added at 50 mg twice daily for two weeks followed by four weeks washout and then dapagliflozin 10mg once daily for two weeks
16057072|NCT02475070|Drug|Dapagliflozin|Dapagliflozin added at 10 mg once daily for two weeks followed by four weeks washout and then vildagliptin 50 mg twice daily for two weeks
16057073|NCT02475057|Drug|Degarelix (LHRH antagonist)|Two initial loading doses of 120mg Degarelix for 1 month followed by 80mg monthly for eleven additional months.
16057074|NCT02475057|Drug|LHRH agonist|LHRH agonist at the discretion of the treating Urologist/Oncologist for 1 year.
16057075|NCT02475057|Device|EndoPAT2000|Peripheral arterial plethysmography using an EndoPAT2000 device
16057077|NCT02475031|Device|TAP-C|TAP catheters with ropivacaine infusion are inserted into the TAP area after a single shot TAP block. Single shot TAP block is performed using 30ml 0.5% ropivacaine at the end of the case.
16057078|NCT02475031|Drug|TAP-S|Catheters with saline infusion are inserted into the TAP area after a single shot TAP block. Single shot TAP block is performed using 30ml 0.5% ropivacaine at the end of the case.
16057079|NCT02475018|Dietary Supplement|Milk fortified with plant sterol esters|250mL of Shuhua milk fortified with plant sterol esters(with plant sterol esters 262mg/100mL) has been taken twice per day. 500mL of Shuhua milk in total has been taken per day during the 60-days intervention.
16057080|NCT02475018|Dietary Supplement|Plain milk|250mL of placebo milk (plain milk) has been taken twice per day. 500mL of plain milk in total has been taken per day during the 60-days intervention.
16057081|NCT02475005|Behavioral|pain self management app on smartphone|
16057082|NCT02474992|Behavioral|Microclinic|Individuals randomized to this arm will be invited to recruit members of their social network to form a health team, or microclinic. These groups will proceed through a discussion-based health education curriculum led by local community health workers. Topics will include HIV biology, medications, the importance of social support, and community outreach for reducing HIV stigma. The curriculum will conclude with an opportunity for all group members to disclose their HIV status to one another.
16057083|NCT02474979|Device|CBPM-system|The bed is equipped with a pressure sensing mat including thousands of sensors. It is connected with a monitor that continuously registers the pressure between the body and the bed surface (interface pressure). The pressure is indicated by colors, where warmer colors indicate higher pressure.
16057084|NCT02474979|Other|Control|
16057085|NCT02474966|Device|Deep Transcranial Magnetic Stimulation (dTMS)|Patients will present on two consecutive days in order to receive dTMS followed by dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI). Subjects will be randomized into two groups: the first group will be treated before with real-dTMS (the first day) and after with sham-dTMS (the second day); the second group will be treated before with sham-dTMS (the first day) and after with realTMS (the second day). At the end of each session of dTMS the patients will undergo by MRI exams.
16057086|NCT02474953|Dietary Supplement|Proprietary Curcumin Formulation|
16057087|NCT02474953|Dietary Supplement|Unformulated Comparator Curcumin Product|
16057088|NCT02474940|Behavioral|Intervention #1|Intervention #1 consists of 11 treatment sessions over 6-12 weeks (1-2 sessions/week on average). Sessions 1-6 will involve neurofeedback training. During neurofeedback training, sensors will be placed on a subject's head and ears, and s/he will be able to hear sounds on a computer that correspond to his/her brainwaves. The subject will learn how to change his/her brainwaves by changing the sounds heard. Session 7 will be a face-to-face self-hypnosis session. During self-hypnosis training, subjects will learn to enter a state of focused attention, and then change how he/she experiences pain and/or fatigue. In sessions 8-11, subjects will listen to an audio recording of a self-hypnosis training session. Subjects will complete one neurofeedback training session immediately before each of these four hypnosis sessions. A relaxation and hypnotic exercise will also be done during two of the 11 sessions.
16057089|NCT02474940|Behavioral|Intervention #2|Intervention #2 consists of 11 treatment sessions over 6-12 weeks (1-2 sessions/week on average). Sessions 1-6 will involve mindfulness meditation training. During mindfulness training, subjects will be asked to focus their attention on an object of awareness, such as their breath. Subjects will then be asked to focus on their feelings/thoughts during the training. Session 7 will be a face-to-face self-hypnosis session. During self-hypnosis training, subjects will learn to enter a state of focused attention, and then change how he/she experiences pain and/or fatigue. In sessions 8-11, subjects will listen to an audio recording of a self-hypnosis training session. Subjects will complete one mindfulness meditation training session immediately before each of these four hypnosis sessions. A relaxation and hypnotic exercise will be done during two of the 11 sessions. On three of the 11 sessions, research staff will also place sensors on a subject's head and ears to measure brainwaves.
16057090|NCT02474940|Behavioral|Intervention #3|Intervention #3 consists of five treatment sessions of self-hypnosis training during the treatment phase of the study (1-2 sessions/week on average). The treatment phase of the study will last about 6-12 weeks. During the first 4-5 weeks, subjects in Intervention #3 will not be asked by study researchers to do anything. At the end of this waiting period, subjects will complete a set of telephone interviews. Subjects will then attend one face-to-face self-hypnosis training session. During self-hypnosis training, subjects will learn to enter a state of focused attention, and then change how he/she experiences pain and/or fatigue. In the last four sessions, subjects will listen to an audio recording of a self-hypnosis training session. A relaxation and hypnotic exercise will also be done during two of the five sessions.
16057091|NCT02474927|Drug|Carfilzomib|Carfilzomib will be used in combination with the conventional therapy (plasma exchange and intravenous immunoglobulins)
16057092|NCT02474914|Drug|Octreotide|Octreotide will be given after PD
16057093|NCT02474914|Drug|Placebo|Octreotide will NOT be given after PD
16057094|NCT02474901|Biological|Quadrivalent Live Attenuated Influenza Vaccine|
16057095|NCT02474888|Other|blood specimen|blood specimen for serum rituximab level and serum anti-rituximab level at M1 and M3 after stop of induction rituximab treatment
16057096|NCT02474875|Other|Educational program|Patients in experimental groups will receive different educational sessions (contents and duration)
16057097|NCT02474862|Behavioral|Prenatal Walking Program|PWP is a gentle walking intervention tailored for pregnant women.
16057098|NCT02474862|Behavioral|Postpartum Prep Program|PPP participants will attend individually education sessions matched in number and duration to the sessions in PWP. PPP involves providing health information particularly relevant to expectant mothers, including both maternal and newborn well being.
16057099|NCT02474849|Other|Use electronic cigarette or smoke conventional cigarette|Use of electronic cigarette or smoking conventional cigarette ad libitum for 5 minute period
16057100|NCT02474836|Biological|Skin Prick Test - Atopic subjects|Skin prick test of 4 concentrations of each allergenic source, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm. Assessment of the wheal size after 15 minutes.
16057316|NCT02473302|Other|marinated cooked sirloin steak|110g per day during 4 days
16060752|NCT02449564|Drug|sirolimus|sirolimus 1mg daily
16057101|NCT02474836|Biological|Skin Prick Test - Non Atopic subjects|Skin prick test of 4 concentrations of each allergenic source, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every subjects in duplicate on the volar surface of the forearm. Assessment of the wheal size after 15 minutes.
16057102|NCT02474836|Biological|Skin Prick Test - Allergic subjects|Skin prick test of 4 concentrations of each allergenic source, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm. Assessment of the wheal size after 15 minutes.
16057103|NCT02474823|Other|polysomnogram|all participants will undergo PSG for assessment of OSA
16057104|NCT02474823|Other|home sleep test|all participants will undergo HST for assessment of OSA
16057105|NCT02474823|Other|Easy Sleep Apnea Predictor|all participants will undergo ESAP for assessment of OSA
16057106|NCT02474810|Drug|Alteplase|Alteplase for CVC dysfunction.
16057107|NCT02474797|Device|Diaphragmatic ultrasonography|"Daily Measure of Diaphragmatic Thickening Fraction (DTF) will be performed by a trained physiotherapist. Physiotherapist (A. LE NEINDRE). The patient will be then instructed to perform breathing to total lung capacity and then to exhale to residual volume, when it is possible (awaken patient). Awakening status will be recorded. Mechanically ventilated patients will be evaluated in Pressure Support (PS) mode (during daily PS mode research for patients with Controlled Ventilation), with the lower PS level tolerated. PS level will be recorded.
~Thickening fraction (TF) measure is performed in B-mode using the following formula: TF (%) = [(end-inspiration thickness - end-expiration thickness)/(end-expiration thickness) x 100]. Diaphragmatic dysfunction is defined like a DTF < 20% (7)."
16057108|NCT02474745|Procedure|- Directed open-glottis pushing|"Description of the intervention in the intervention group: Directed open-glottis pushing (with prolonged exhalation) must be explained to the women and professionals as follows:
~After inhaling deeply, the patient will exhale while pulling in her stomach in such a way they she can use the contraction of her abdominal muscles to help the fetus descend through the birth control. She should push as long as possible
~Description of the intervention in the control group: Directed closed-glottis pushing (pushing while holding one's breath) should be explained to the women and professionals as follows:
~After inhaling deeply, the patient should push very hard downwards to the perineum, while holding the inhaled breath in her lungs. She should push as hard and as long as possible."
16057109|NCT02474745|Procedure|Directed closed-glottis pushing|"Description of the intervention in the intervention group: Directed open-glottis pushing (with prolonged exhalation) must be explained to the women and professionals as follows:
~After inhaling deeply, the patient will exhale while pulling in her stomach in such a way they she can use the contraction of her abdominal muscles to help the fetus descend through the birth control. She should push as long as possible
~Description of the intervention in the control group: Directed closed-glottis pushing (pushing while holding one's breath) should be explained to the women and professionals as follows:
~After inhaling deeply, the patient should push very hard downwards to the perineum, while holding the inhaled breath in her lungs. She should push as hard and as long as possible."
16057110|NCT02474732|Device|Beactive(r) Brace|Determine if the subjects are able to understand and follow the directions to apply the Beactive Brace.
16057111|NCT02474719|Other|comparison of two regimens in peritoneal dialysis|Dialysate samples (8 by scheme, volume of 10 mL) are collected at each cycle (one at the beginning and one at the end of the cycle). A blood sample (5 mL) is collected at the beginning of the second scheme and a 24-hour urine sample at the end of the second scheme.
16057112|NCT02474706|Drug|Cefoxitin|
16057113|NCT02474706|Drug|imipenem|
16057114|NCT02474680|Genetic|Pharmacogenetic testing|Psychotropic genotyping panel
16057115|NCT02474667|Drug|ANG-3777|
16057116|NCT02474667|Other|Placebo|
16057117|NCT02474654|Drug|Bupivicaine|15mg
16057118|NCT02474654|Drug|Fentanyl|15mcg
16057119|NCT02474654|Drug|Epimorphine|150mcg
16057120|NCT02474654|Drug|Normal Saline|0.3 ml
16057121|NCT02474654|Drug|Normal Saline|30ml
16057122|NCT02474654|Drug|Normal Saline|100 ml
16057123|NCT02474654|Drug|Ropivicaine|100 ml
16057124|NCT02474654|Drug|Epinephrine|600 mcg
16057125|NCT02474654|Drug|Ketorolac|30 mg
16057126|NCT02474654|Drug|Ropivicaine with Epinephrine|0.5% 1:400,000 30ml
16057127|NCT02474641|Radiation|Standard Radiation|"Conventionally fractionated radiotherapy of the breast followed by a tumor bed boost sequentially or
~Conventionally fractionated radiotherapy of the breast with simultaneous integrated boost to the tumor bed or
~Hypofractionated radiotherapy of the breast followed by a tumor bed boost sequentially"
16057128|NCT02474641|Radiation|Hypofractionation with SIB|Hypofractionated radiotherapy of the breast with simultaneous integrated boost to the tumor bed
16057129|NCT02474628|Dietary Supplement|sodium bicarbonate|
16057130|NCT02474628|Dietary Supplement|calcium carbonate|
16057131|NCT02474615|Procedure|ENDODONTIC SURGERY|ENDODONTIC SURGERY
16057132|NCT02474602|Device|Active or Placebo Phototherapy (MR4)|Participants performed a strength training. Forty-eight subjects practiced a training protocol with 80% of the load, measured through 1-repetition maximum test. The strength training lasted 12 weeks and the evaluations were done monthly. Phototherapy, active or placebo, were applied in 6 different points of quadriceps muscle depending the group randomized, before and after each training session.
16057133|NCT02474589|Drug|tecovirimat|Study is based on Animal Regulatory Rule
16057134|NCT02474589|Other|Placebo|Does not apply
16057135|NCT02474576|Procedure|Percutaneous aponeurotomy|The finger(s) with limited extension due to Dupuytrens disease and for which the patient desires treatment, will be treated by fine-needle percutaneous aponeurotomy under local anesthesia (outpatient procedure). This procedure is already routinely used in clinical practice ; our study aims at better describing the time-sustainability of its benefits.
16057136|NCT02474563|Drug|Bortezomib|Participants receiving Bortezomib 1.3 milligram per square meter (mg/m2) will be observed in this study.
16057137|NCT02474563|Drug|Melphalan|Participants receiving Melphalan 9 mg/m^2 will be observed in this study.
16057138|NCT02474563|Drug|Prednisone|Participants receiving Prednisone 60 mg/m^2 will be observed in this study.
16057139|NCT02474537|Drug|INC280|Single 200 mg dose INC280
16057140|NCT02474524|Behavioral|Health intervention|Participants will receive 8 50-minute sessions during a 3 month window with a mental health worker, in addition to their routine care. Sessions will be structured by the worker and participant using a tablet computer to view materials on mental health self-management and personal recovery on a dedicated website for the trial. These will include information, videos, audio and exercises. Online materials make particular use of videos featuring people with lived experience of psychosis discussing how they have dealt with issues in their recovery, and will allow users to post comments on videos and in a forum. Participants may access online materials both during intervention sessions and outside sessions using any Internet-enabled device.
16057141|NCT02474524|Behavioral|Social intervention|Participants will receive 8 50-minute sessions during a 3 month window with a mental health worker in addition to routine care (treatment as usual). The social intervention will utilise a computer tablet (i.e., iPad) servicing online resources to extend a manualised befriending intervention, based upon social interaction, designed to control for therapist contact and computer use. Each session will involve interaction about non-health related topics of interest to the participants, which will be facilitated by use of viewing online material related to these interests on a tablet computer as a prompt to conversation.
16057142|NCT02474511|Other|general anesthesia and local anesthesia|the patient received generalanesthesia and local anesthesia randomly
16057143|NCT02474498|Drug|EMD|During flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments. The furcation defects in this group will receive the application of enamel matrix derivative (EMD - Emdogain® Straumann, Basel, Switzerland).
16057144|NCT02474498|Device|βTCP/HA|During flap access surgery, the granulation tissue will be removed and the root surfaces were carefully instrumented with ultrasonic and hand instruments. The furcation will be filled with a bone substitute consisting of beta tricalcium phosphate/hydroxyapatite (βTCP/HA- Bone Ceramic® Straumann, Basel, Switzerland)
16057145|NCT02474498|Procedure|Flap access surgery|In the furcation sites, during flap access surgery, the granulation tissue will be removed and the root surfaces will be carefully instrumented with ultrasonic and hand instruments.
16057146|NCT02474485|Device|BVS Absorb implantation.|Absorb bioresorbable vascular scaffold will be implanted to treat in stent restenosis in target vessel.
16057147|NCT02474485|Device|DEB Sequent Please inflation.|Inflation of drug eluting balloon Sequent Please will be performed to treat in stent restenosis in target vessel.
16057148|NCT02474485|Procedure|Control coronary angiography.|Control coronary angiography will be performed at 9 month follow-up.
16057149|NCT02474485|Procedure|OCT visualization.|OCT visualization will be performed during index procedure and at 9 month follow-up.
16057150|NCT02474485|Other|Clinical observation.|Patients will be informed that Investigator will contact them at 12, 24 and 60 months after the procedure. Investigator will collect information regarding clinical status of Patients, cardiac medications and any adverse events that occurred since the last follow-up.
16057151|NCT02474459|Device|iPad-Based Clinical Support Care|Subjects in this treatment arm will receive deep brain stimulation (DBS) programming at regular intervals as part of routine clinical care. DBS stimulation programming will be done with the use of a iPad-based decision support system.
16057152|NCT02474459|Other|Standard Clinical Care|Subjects in this treatment arm will receive DBS programming at regular intervals as part of routine clinical care.
16057153|NCT02474446|Dietary Supplement|Vitamin D|150,000 IU of Vitamin D3 Oral solution
16057154|NCT02474433|Drug|Misoprostol (Cytotec)|
16057155|NCT02474420|Drug|Amlodipine|amlodipine titrated up to 10 mg daily or maximum tolerated dose, whichever comes first
16057156|NCT02474420|Drug|Deferasirox|Deferasirox administered per standard of care by the treating physician
16057157|NCT02474407|Drug|diazepam nasal spray|
16057158|NCT02474407|Drug|diazepam rectal gel|
16057159|NCT02474394|Device|Mcgrath|The patient will be intubated using McGrath series 5 video laryngoscope and the intraocular pressure of the patient will be evaluated with Tonopen XL tonometer
16057160|NCT02474394|Device|Macintosh|The patient will be intubated using Macintosh laryngoscope and the intraocular pressure of the patient will be evaluated with Tonopen XL tonometer
16057161|NCT02474381|Biological|EPCs plus PTA|Intra-arterial infusion of autologous CD133+ cells on diabetic subjects with PAD,plus angioplasty
16057162|NCT02474381|Device|Single PTA|Angioplasty of arteries below tibial plateau level only
16057163|NCT02474368|Radiation|Intensity Modulated Radiation Therapy (IMRT)|
16057164|NCT02474368|Drug|Cisplatin|
16057165|NCT02474368|Radiation|Stereotactic Body Radiotherapy (SBRT)|
16057171|NCT02474342|Biological|Autologous Adipose Tissue Derived MSCs Transplantation|"Study drugs: Autologous adipose tissue derived MSCs
~Injection dosage and volume of the study drugs:
~Low dose: 1x10e7 cells/3mL
~Number of injections : only once during the study period
~Device: Ultrasound
~Injection technique: Injection into the lesion by investigator"
16057172|NCT02474342|Biological|Autologous Adipose Tissue Derived MSCs Transplantation|"Study drugs: Autologous adipose tissue derived MSCs
~Injection dosage and volume of the study drugs:
~Mid dose: 5x10e7 cells/3mL
~Number of injections : only once during the study period
~Device: Ultrasound
~Injection technique: Injection into the lesion by investigator"
16057173|NCT02474342|Biological|Autologous Adipose Tissue Derived MSCs Transplantation|"Study drugs: Autologous adipose tissue derived MSCs
~Injection dosage and volume of the study drugs:
~High dose: 1x10e8 cells/3mL
~Number of injections : only once during the study period
~Device: Ultrasound
~Injection technique: Injection into the lesion by investigator"
16057174|NCT02474329|Other|Clinical assessment|During the 13 week follow-up, trained physiotherapists will perform a standardized clinical assessment, based on the PPMI protocol (www.ppmi-info.ors) for every included patient. This assessment will last for 60 minutes, and it will be done once.
16057175|NCT02474329|Device|Fox Insight self-monitoring android app and falls detector|Patients will be asked to wear a smartwatch and a pendant movement sensor, both with triaxial accelerometers, during day and night, for a period of 13 weeks. Additionally, a self-monitoring App on a Smartphone is used, where the patient reports when (s)he takes any PD medication. An additional, optional button allows the patient to report general feeling.
16057176|NCT02474316|Drug|Peginterferon alfa-2a|Peginterferon alfa-2a 180ug/wk s.c for 48 weeks
16057177|NCT02474316|Drug|nucleos(t)ide analgoue|nucleos(t)ide analgoue (NA) 1 piece p.o for 48 weeks
16057178|NCT02474303|Drug|Truvada|Demonstration Study
16057179|NCT02474290|Drug|Sorafenib|The initial dose of sorafenib is 400 mg orally twice daily and is adjusted in case of suspected toxicity or resistance (dose range, 200-800 mg daily).
16057180|NCT02474277|Other|30 sec chair stand test|diagnostic test for functional impairment
16057181|NCT02474264|Other|Endothelial function assessment|reactive hyperemia index
16057182|NCT02474264|Other|Cardiovascular biomarkers|Cardiovascular biomarkers will be measure to test other aspects of endothelial and cardiac function: high-sensitivity troponin (hsTn) , C-reactive protein , D-dimer, N-terminal pro-brain natriuretic peptide (NT-proBNP)
16057183|NCT02474264|Other|Endothelial cells|Endothelial Progenitor Cells and Circulating Endothelial Cells profiles- will be characterized to evaluate endothelial injury.
16057184|NCT02474251|Other|Continuous positive airway pressure device|GROUP B ONLY will be evaluated on two randomized counterbalanced nights, on one they will undergo a full night of therapeutic CPAP; on the other the investigators will withdraw CPAP during SWS only. A morning LP will be performed approximately 10 hours after sleep onset in both visits
16057185|NCT02474238|Device|The sequential technique|By using 'the double frequency YAG laser' to make the initial bore and 'the Nd:YAG laser' to complete the perforation on iris.
16057186|NCT02474238|Device|The pure Nd:YAG laser technique|By using 'the pure Nd:YAG laser' to make a complete perforation on iris.
16057187|NCT02474225|Drug|Intravitreal injection (bevacizumab or ranibizumab)|The intravitreal anti-vascular endothelial growth factor agent of 0.1 ml of bevacizumab (2.5 mg/0.1 ml) or ranibizumab (1 mg/0.1 ml)
16057188|NCT02474212|Drug|Enoxaparin|
16057189|NCT02474199|Biological|darTregs|A single intravenous infusion as described administered over a 20-30 minute interval with close monitoring prior to, during, and after the infusion.
16057190|NCT02474199|Drug|Acetaminophen|Pre-medication for darTregs infusion. A dose of 15 mg/kg will be administered 30 to 60 minutes prior to the darTregs infusion.
16057191|NCT02474199|Drug|Diphenhydramine|Pre-medication for darTregs infusion. A dose of 1-2 mg/kg diphenhydramine will be administered 30 to 60 minutes prior to the darTregs infusion.
16057192|NCT02474199|Drug|Immunosuppression (IS) Withdrawal|"Subjects:1.) who fulfill study eligibility criteria will withdraw IS 2.) enter the study on calcineurin inhibitor (CNI) monotherapy or a CNI-based regimen with either Prednisone or MMF as a second IS medication 3.) will proceed with changes in CNI dosing according to the protocol's CNI withdrawal algorithm.During the last 2 weeks of IS withdrawal (e.g., Step 2 in algorithm -CNI reduced 25%-pre darTregs), a single dose of darTregs will be infused IV. The subject will then, if eligible, proceed with IS withdrawal within 2 weeks after the infusion. Eligible subjects meeting the primary endpoint of 75% reduction in CNI from baseline after darTregs will be offered the opportunity to continue IS withdrawal until complete discontinuation of IS."
16057193|NCT02474199|Procedure|Study Mandated Procedures|Blood draws (venipuncture); collection of peripheral blood mononuclear cells (PBMCs) by a procedure known as leukapheresis or venipuncture; buccal (cheek) swab for HLA typing; liver biopsies (per protocol and for cause).
16057194|NCT02474186|Radiation|Radiation therapy|Patients with metastatic breast cancer and other metastatic solid tumors receiving single-agent chemotherapy will receive 3.5 Gy/fraction to a total dose of 35 Gy/10 fractions over 2 weeks with concurrent systemic therapy
16057195|NCT02474186|Drug|Xeloda|chemotherapy agent daily for two weeks
16057196|NCT02474186|Drug|paclitaxel|chemotherapy agent weekly for two weeks
16057197|NCT02474173|Other|Laboratory Biomarker Analysis|Correlative studies
16057198|NCT02474173|Drug|Onalespib|Given IV
16057199|NCT02474173|Drug|Paclitaxel|Given IV
16057200|NCT02474173|Other|Pharmacological Study|Correlative studies
16057201|NCT02474160|Other|Cytology Specimen Collection Procedure|Procurement of tissue and blood samples
16057202|NCT02474147|Other|Processed meat hamburger|MacMuffin Fresh 300 ml Cafe Latte + 21 g sugar Energy: 513.6 kcal Carbohydrates 55g (44.8%) Proteins 20.5g (16.7%) Lipids 22 g (38.6%)
16057203|NCT02474147|Other|Vegan sandwich|Burger with tofu + 300 ml green tea Energy 514.9 kcal Carbohydrates 54.2 g (44%) Proteins 19.9 g (16.2%) Lipids 22.8 g (39.8%)
16057204|NCT02474134|Drug|Interferon beta-1b (PF530, Betaferon)|Single subcutaneous administration
16057205|NCT02474121|Device|Bone marrow concentration device|Collection of autologous bone marrow aspirate and point-of-care concentration using the bone marrow concentration device, followed by intramuscular injection of concentrated bone marrow aspirate (cBMA) into the affected limb
16057206|NCT02474108|Procedure|surgical prevention of atrial fibrillation|Prophylactic surgical ablation is performed to prevent AF in patients during mitral valve surgery. Ablation is performed by radiofrequency electrode or cryoprobe. Pulmonary veins, posterior wall of the left atrium will be isolated by the scheme box-lesion with additional lines to the mitral valve and appendage of left atrium.
16057207|NCT02474108|Device|cardiomonitor|in both groups cardiac rhythm will be controlled by a cardiomonitor
16057208|NCT02474095|Other|Quality-of-Life Assessment|Ancillary studies
16057209|NCT02474095|Procedure|Transcutaneous Acupoint Electrical Stimulation|Undergo ALTENS
16057210|NCT02474082|Biological|Secukinumab|Secukinumab 150 mg, 1 ml liquid formulation in a pre-filled pen for s.c. injection
16057211|NCT02474082|Drug|Fumaric acid|Fumaric acid initial therapy (tablet contains 30 mg dimethylfumarate, 67 mg ethylhydrogenfumarate calcium salt, 5 mg ethylhydrogenfumarate magnesium salt, 3 mg ethylhydrogenfumarate zinc salt) and Fumaric acid maintenance therapy (tablet contains 120 mg dimethylfumarate, 87 mg ethylhydrogenfumarate calcium salt, 5 mg ethylhydrogenfumarate magnesium salt, 3 mg ethylhydrogenfumarate zinc salt)
16057212|NCT02474069|Drug|Secukinumab|
16057317|NCT02473289|Drug|Sirukumab 50 mg|Participants will receive sirukumab 50 mg as subcutaneous injection on Day 1, 28 and 56.
16061138|NCT02446899|Drug|Placebo|Intravenous infusion (IV)
16057213|NCT02474043|Behavioral|Hep-Net Intervention|The Hep-Net Intervention is a web-based questionnaire and tailored feedback system designed to increase readiness to change with respect to several behaviors. The behaviors include (1) reducing or quitting drug use; (2) using sterile equipment every time one injects drugs; (3) undergoing screening for hepatitis C; (4) receiving training to use naloxone to prevent death due to opioid overdose.
16057214|NCT02474043|Behavioral|Usual Care|Clients receive health education and risk reduction counseling from a trained prevention specialist.
16057215|NCT02474017|Drug|MGR001|Fluticasone Propionate / Salmeterol administered using CRC749 inhaler
16057216|NCT02474017|Device|CRC749 inhaler|
16057217|NCT02474004|Procedure|medial meniscal surgery|one group/arm has meniscal repair as part of clinical routine one group/arm has meniscal partial resection as part of clinical routine both groups have gait analysis & knee scores 6 mo after the procedures
16057218|NCT02473991|Radiation|ultrasound|The placental thickness was measured by placing the ultrasound transducer perpendicularly to the plane of the placenta, in the area of the cord insertion, near the mid-placental portion
16057219|NCT02473978|Device|INVOS Cerebral Oximetry|Participants will be connected to INVOS Cerebral Oximetry Cerebral Oximetry preoperativly and intraoperativly to ascess there cerebral perfusion throughout cesarean sections.
16057220|NCT02473965|Drug|IGIV-C|"Run-Phase: 1 loading dose of 2 g/kg IGIV-C and 2 maintenance doses of 1 g/kg IGIV-C
~Corticosteroid Tapering/IGIV-C Maintenance Phase: 1 g/kg IGIV-C every 3 weeks for up to 36 weeks"
16057221|NCT02473965|Drug|Placebo|
16057222|NCT02473952|Drug|IGIV-C|IGIV-C: Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified
16057223|NCT02473952|Drug|Placebo|
16057224|NCT02473939|Drug|VR942 delivered via a Vectura Dry Powder Inhaler|
16057225|NCT02473939|Drug|Placebo delivered via a Vectura Dry Powder Inhaler|
16057226|NCT02473926|Behavioral|Physical Activity|Physical Activity Program Intervention
16057227|NCT02473926|Behavioral|Questionnaires|Participants in the usual care arm will receive three mailings during the intervention phase.
16057228|NCT02473913|Drug|Milk Thistle|
16057229|NCT02473913|Drug|Placebo|
16057230|NCT02473900|Drug|HIP1403|Oseltamivir 75mg
16057231|NCT02473900|Drug|HGP0919|Oseltamivir phosphate 75mg
16057232|NCT02473887|Drug|Ondansetron with1:1 ORA - sweet.|single dose of intravenous ondansetron form orally after being flavored with 1:1 ORA-sweet, the dose of ondansetron was determined based on the patient presenting weight.
16057233|NCT02473874|Device|Skin Spect dermoscope|Skin imaging
16057234|NCT02473874|Device|Spatially modulated quantitative|Skin imaging
16057235|NCT02473861|Other|Exercise|Moderate intensity aerobic and resistance training. Five minutes each of warm-up, cool-down, balance and flexibility will also be performed.
16057236|NCT02473848|Drug|ingenol mebutate 500 ucg|Ingenol mebutate gel, 0.05%, commercially supplied in a box of 2 single use, unit dose tubes for topical application for each 25cm2, four conjunctive 25cm2 areas (100cm2) will be treated. If the 100 cm2 area is not cleared at Day 57 (+/- 3 Days), a second treatment cycle will be initiated with commercially supplied drug in a box of 2 single use, unit dose tubes for topical application for each 25cm2 and four conjunctive 25cm2 areas (100cm2 ) will be treated. In total for the first cycle, 4 commercially supplied boxes (8 unit dose tubes) will be used, and for the second cycle an additional 4 commercially supplied boxes (8 unit dose tubes) will be used (in total 8 boxes, 16 unit dose tubes per patient).
16057237|NCT02473835|Other|Calorie restriction|Participants will reduce calorie intake by 50 % for a period of 3 consecutive days.
16057238|NCT02473835|Other|Activity monitoring|For 1 week, participants will be fitted with an activity monitor (Actiheart) to estimate energy expenditure (during the same week as the diet monitoring). The activity and diet monitoring data will be used together to confirm that participants are in a state of energy balance and an average of these 2 values taken - 50 % of this average value will be the target calorie intake for the 3 day calorie restriction period.
16057239|NCT02473835|Other|Diet monitoring|For 1 week, participants will be asked to record all food and fluids consumed to estimate energy intake (during the same week as the activity monitoring). The activity and diet monitoring data will be used together to confirm that participants are in a state of energy balance and an average of these 2 values taken - 50 % of this average value will be the target calorie intake for the 3 day calorie restriction period.
16057240|NCT02473809|Drug|Liraglutide|Once daily
16057241|NCT02473809|Drug|Placebo|Once daily
16057242|NCT02473796|Other|Home based child care|HBNC included treatment of neonatal sepsis with Gentamicin once daily (5 mg for 10 days for preterm babies with birth weight <2000g; 7 mg for birth weight 2000-2500 gm or as per gentamicin chart for 7 days for normal term & weight ) by intramuscular injection. Acute respiratory infection was treated with co-trimoxazole syrup BID (2.5 ml for age 1-2 months, 5 ml for age 2 months - 1 year, 7.5 ml for age 1 - 5 years). Diarrheal illness was treated with ORS, furoxone (5 ml 8 hourly for 3 days) and metronidazole syrup (5 ml 8 hourly for 7 days). Malaria was treated with Syrup chloroquine (for 1 month to 1 year- 5 ml first dose , 2.5 ml after 6 hours, 2.5 ml after 12 hours , 2.5 ml after 12 hours). Syrup paracetamol was given 2.5 to 5 ml 8 hourly depending upon the body weight.
16057243|NCT02473783|Drug|Sertraline HCl|The regimen of Sertraline HCl will be administered with starting dose from minimum 25 mg/day for 1 week and maintenance dose of at least 50 mg/day up to 200 mg/day for the rest of 5 weeks.
16057244|NCT02473783|Other|I-123-ADAM SPECT|The subjects underwent the SPECT scan after I-123-ADAM (185 MBq, 5mCi) IV injection.
16057245|NCT02473744|Other|subcutaneous drainage|After topic analgesia, three subcutaneous channels are created and an absorbent pad collects the lymphatic fluid.
16057246|NCT02473731|Biological|KTN3379|
16057247|NCT02473718|Other|Fluid minimization protocol|Fluid nonresponsive patients will have continuous infusions concentrated, maintenance fluids discontinued, and carrier fluids minimized. Diuretics and/or ultrafiltration will be utilized to maintain an even to negative fluid balance in patients demonstrating fluid non-responsiveness.
16057248|NCT02473718|Device|Ultrasound|
16057249|NCT02473705|Dietary Supplement|Fish Oil and Bicarbonate|1280mg of fish oil per day and 1mg of bicarbonate per Kg of body weight per day
16057250|NCT02473705|Dietary Supplement|Fish Oil and Bicarbonate Placebo|1280mg of fish oil per day and bicarbonate placebo (Methylcellulose)
16057318|NCT02473289|Drug|Placebo|Participants will receive matching placebo on Day 1, 28 and 56.
16057253|NCT02473692|Other|Online Migraine Treatment Optimization|"The educational videos entail a young woman (i.e., an actress) describing her experiences in managing her headaches. The informational content of the videos is organized into 7 content areas that present a wealth of information in an entertaining way:
~Introduction to the series
~Getting to know migraine
~Making the most of your medical care
~Partnering with your doctor
~Best use of migraine medication
~Keeping tabs on your migraine
~Take home message (summary)"
16057254|NCT02473653|Biological|HER-2/neu Pulsed DC1 vaccine|There will be no exceptions to eligibility, contraindicated treatment/therapies/interventions or safety tests.
16057255|NCT02473640|Drug|SYN-004|
16057256|NCT02473640|Drug|Esomeprazole|
16057257|NCT02473640|Drug|Ceftriaxone|
16057258|NCT02473627|Drug|DS-1971a|200mg tablet
16057259|NCT02473627|Drug|midazolam hydrochloride|2.5mg oromucosal liquid
16057260|NCT02473627|Drug|Omeprazole|20mg gastro-resistant capsule
16057261|NCT02473627|Drug|Pioglitazone hydrochloride|15mg tablet
16057262|NCT02473627|Drug|Buproprion|150mg Prolonged release tablet
16057263|NCT02473627|Drug|Tolbutamide|500mg tablet
16057264|NCT02473614|Device|Music Glove|Participants will exercise at home using the music glove for 3 times a week for 3 weeks with a minimum of 3 hours per week.
16057265|NCT02473614|Other|Conventional Hand Exercise Program|Participants will exercise at home using the hand exercise program designed by an occupational therapist for 3 times a week for 3 weeks with a minimum of 3 hours per week.
16057266|NCT02473601|Drug|Mivacurium Chloride|"Anesthesia induction:
~Intravenous injection of midazolam 0.05 mg/kg,Etomidate 0.3 mg/kg,Sufentanil 0.5 g/kg,TOF detection and adjustment of the first twitch height (T1)100%, Mivacurium Chloramine 0.07 mg/kg intraveous injecting in 5 minutes.
~Anesthesia maintenance:
~Two groups of sevoflurance 1%~8% inhalation anesthesia plus intravenous infusion of remifentanil 0.05～0.2 µg/kg/min,Mivacurium Chloramine 6mg/kg/h, Appropriate supplementary analgesia dose of sufentanil before skin incision and the abdomen was closed. The two groups were maintained until the Bis value was 40 ~ 60. PetCO2 was 30 ~ 35mmHg. Hemodynamic fluctuations did not exceed 20% of the baseline value.At least 20 minutes before the operation stopping Mivacurium infusion,Before the end of operation 5-10 minutes stopping infusion of remifentanil and sevoflurane."
16057267|NCT02473588|Device|Retia Medical Long Time Interval Analysis|"Retia Medical Long Time Interval Analysis will be used to analyze the blood pressure tracing of patients having surgery who have an arterial catheter"
16057268|NCT02473575|Dietary Supplement|caffeine gum|Gum is consumed 30 minutes before commencement of run
16057269|NCT02473575|Dietary Supplement|placebo gum|Gum is consumed 30 minutes before commencement of run
16057270|NCT02473562|Drug|Varenicline|Tablet 1 mg BID
16057271|NCT02473562|Drug|Placebo (for varenicline)|Tablet 1 mg BID
16057272|NCT02473549|Device|Sham TDCS|Placebo stimulation is applied to the unaffected motor cortex while participants perform rehabilitation exercises for the upper extremity
16057273|NCT02473549|Device|Anodal TDCS|Excitatory stimulation is applied to the unaffected motor cortex while participants perform rehabilitation exercises for the upper extremity
16057274|NCT02473549|Device|Cathodal TDCS|Inhibitory stimulation is applied to the unaffected motor cortex while participants perform rehabilitation exercises for the upper extremity
16057275|NCT02473549|Device|Magnetic Resonance Imaging (MRI)|Participants will receive a MRI of their brain to allow the research investigators to determine how the stroke has affected regions of the brain processing movements.
16057276|NCT02473536|Radiation|Stereotactic ablative radiation therapy|SABR
16057277|NCT02473523|Other|PedsQL Cancer Module|The PedsQL cancer module acute version is a 27 item assessment that includes eight scales including pain (2 items), nausea (5 items), anxiety related to procedures (3 items), anxiety related to treatment (3 items), worry (3items), cognitive problems (5 items), perceived physical appearance and communication (3 items). This assessment will take approximately 15-30 minutes to complete.
16057278|NCT02473523|Other|PedsQL Multidimensional Fatigue Scale|The Multidimensional Fatigue Scale is an 18 item questionnaire encompassing 3 subscales including general fatigue (6 items), sleep and rest fatigue (6 items) and cognitive fatigue (6 items). This assessment will take approximately 10-20 minutes to complete.
16057279|NCT02473523|Device|Biodex System 3 Dynamometer|"The Biodex System 3 Dynamometer will be used to measure isometric quadriceps muscle contractions. Participants will be stabilized in the chair with abdominal and shoulder straps. The isometric tests for knee extension will be done on both dominant and non-dominant leg. The tests consist of 3 maximal muscle contractions each lasting five seconds separated by 40 second rest intervals. This assessment will take approximately 10 minutes to complete."
16057280|NCT02473523|Device|Jamar Hydraulic Hand Dynamometer|"A calibrated Jamar hydraulic hand dynamometer will be used to measure grip strength. The participant will be seated in a chair with elbow flexion to 90 degrees against torso and the forearm in neutral. The participant will grasp the device and the handle will be adjusted so that digits are able to comfortably grasp the device. The maximum score after 2 trials will be recorded as grip strength for both right and left hand. This assessment will take no more than 5 minutes to complete."
16057281|NCT02473523|Other|Sit and Reach Test|Hamstring flexibility will be assessed by the Sit and Reach Test. The sit and reach is a test to measure hip, hamstring and lower back flexibility. To measure flexibility participants will perform the YMCA sit and reach test. Participants will sit down without shoes or socks with the soles of their feet against the vertical platform of the sit-and-reach box located at the 26 cm (a little over 10 inches) mark. Participants keep their legs straight and their hands overlapped, while reaching for a less than maximum distance twice as a warm-up. This test will take no more than 5 minutes to complete.
16057282|NCT02473523|Other|Test of Motor Proficiency|The Bruininks-Oseretsky Test of Motor Proficiency is a 9 item standardized assessment that includes standing with feet on a line with eyes open and closed, standing on a line with one foot with eyes open and closed, standing on a balance beam on one leg with eyes open and closed and standing heel to toe on a balance beam. These tests will be administered no more than two times with a maximum score of 10 seconds. Two additional subtests include walking forward on a line and walking heel to toe on a line for a maximum of 6 steps for both tasks. Total time to complete this test is approximately 10-20 minutes.
16057319|NCT02473276|Drug|Morphine|preservative free morphine given either via an epidural or intrathecal catheter
16057320|NCT02473276|Drug|Sterile normal saline|sterile normal saline, given either via an epidural or intrathecal catheter
16057283|NCT02473523|Other|Verbal Numeric Pain Scale|The verbal numeric pain scale will be administered before and after each yoga session. The principal investigator (PI) will ask the participant about his/her pain on a scale of 0-10 and the PI will record the number. This will take less than 10 seconds.
16057284|NCT02473523|Other|:Yoga Therapy|Those who consent will participate in 60-minute yoga sessions 2-3 times per week for 4-6 weeks. Only specified yoga poses will be implemented during the classes. Additional detail is included in the Description sections of this registration. The principal investigator is a Certified Yoga Therapist (CYT) and is a registered yoga teacher with 500 hours of training (RYT 500).
16057285|NCT02473510|Biological|Trivalent Influenza Vaccine|A single dose of 10^(7.0 ± 0.5) FFU per strain of trivalent influenza vaccine will be administered as intranasal spray on Day 1.
16057286|NCT02473510|Other|Placebo|A single dose of placebo matched to trivalent influenza vaccine will be administered as intranasal spray on Day 1.
16057287|NCT02473497|Drug|Crizotinib|For adult patients, crizotinib 250 mg BID will be administered orally at approximately the same time each day on a continuous daily dosing schedule, ie, without break in dosing. For pediatric patients, crizotinib 280 mg/m2 BID will be administered orally at approximately the same time each day on a continuous daily dosing schedule, ie, without break in dosing.
16057288|NCT02473471|Device|Micro-osteoperforation|Three Micro-osteoperforation (MOPs) will be performed distal to canine by Mini screw. Before the application of the MOPs, Patient will be asked to wash their mouth twice by chorhexidine for 1 minute.
16057289|NCT02473458|Drug|Licorice whole extract|"Patients randomly received one of below capsules labeled with codes during the first 24 hours after stroke attack:
~Starch-filled capsules (as placebo)
~450 mg whole licorice extract capsules
~900 mg whole licorice extract capsules"
16057290|NCT02473458|Drug|Placebo|
16057291|NCT02473445|Drug|Cysteamine Bitartrate|Cysteamine Bitartrate Delayed-release capsules
16057292|NCT02473432|Procedure|RMT + usual care|Respiratory muscle training is performed with the Orygen Dual valve (inspiratory and espiratory trainer)
16057293|NCT02473432|Procedure|NMES|Neuromuscular electrical stimulation is performed with the Vital Stim ® device (approved by the FDA for dysphagia treatment). It consists in the placement of two electrodes located in suprahyoid muscles as above described.
16057294|NCT02473432|Procedure|Usual care|Standard swallow therapy consists of physiotherapy, occupational therapy and speech therapy targeting specific swallow impairments. In the case of dysphagia, the standard pattern includes measures to protect the airway and compensatory techniques.
16057295|NCT02473419|Drug|Vayarin|
16057296|NCT02473419|Drug|Placebo|
16057297|NCT02473406|Drug|Thymosin Alpha 1|In addition to the standard treatment, thymosin therapy will be started after admission: 1.6mg I.H q12h for the first 7 days and 1.6mg I.H, qd for the following 7 days or until discharge.
16057298|NCT02473406|Drug|normal saline|Placebo inject will be given at the same dose as Thymosin in addition to the standard treatment.
16057299|NCT02473393|Drug|OPS-2071 tablet|
16057300|NCT02473380|Device|Fluorescence spectroscopy guided surgery|A prototype of intraoperative fluorescence spectroscope will be used for fluorescence spectroscopy during a surgical procedure (open surgical approach only). The experimental probe dedicated to the spectroscopic system will be positioned against the surface of the brain, emission spectrum will be acquired and measured, and finally compared with anatomopathology exams. One specific medication will be used as contrast agent in the study: 5 amino-levulinic hydrochloride (GLIOLAN, MEDAC) orally at the dose of 20mg/kg of body weight.
16057301|NCT02473367|Drug|Raltegravir 1200 mg|Two tablets of 600 mg raltegravir administered orally, once daily, over 5 days of Pre-treatment, and once at the start of Periods 1-4.
16057302|NCT02473367|Drug|TUMS|Three tablets of TUMS Ultra Strength (US) 1000, taken orally, concomitantly with raltegravir in Period 2, and 12 hours after raltegravir in Period 4
16057303|NCT02473367|Drug|Leader Antacid|20 mL Leader Antacid Maximum Strength (MS) taken orally 12 hours after raltegravir, in Period 3
16057304|NCT02473354|Drug|Remifentanil|The opioid used for this study is Remifentanil and is commonly used in the operating room. Remifentanil will be given under normoxic (breathing room air [21% Oxygen]) and hyperoxic (breathing 50% oxygen) conditions to determine if the measurement of the specific respiratory parameters will predict the OIRD response.
16057305|NCT02473354|Drug|Oxygen|Remifentanil will be administered under normal oxygen (normoxia) and increased oxygen (hyperemic) conditions.
16057306|NCT02473354|Drug|Carbon dioxide|Carbon dioxide is used as part of the hypercapnia ventilatory response measurement (HCVR)
16057307|NCT02473341|Drug|Bovine Colostrum|"Protein 1.5 gm/kg/day, energy (kcal) 30-40/day, B complex vitamins daily. Pasteurized Bovine colostrum as a freeze dried powder (20 gm thrice a day) for 4 weeks.
~+ Antibiotics + Diuretics +Terlipressin for HRS + acid suppression for prophylaxis against gastrointestinal hemorrhage + EVL for variceal bleed +drugs for HE if indicated"
16057308|NCT02473341|Drug|Placebo|"Protein 1.5 gm/kg/day, energy (kcal) 30-40/day, B complex vitamins daily. Placebo (Pasteurised Milk Powder) 20 gms thrice a day for 4 weeks
~+ Antibiotics + Diuretics + drugs for HE + Terlipressin for HRS + acid suppression for prophylaxis against gastrointestinal hemorrhage + EVL for variceal bleed + if indicated."
16057309|NCT02473328|Drug|Atazanavir 200 mg/r|"In patients signed an informed consent and meeting all the eligibility criteria at the time of the run-in (S-4),
~switch of antiretroviral therapy Atazanavir 300 mg/ritonavir 100 mg once a day to Atazanavir 200 mg/ritonavir 100 mg once a day without changing the combination of 2 NRTIs associated.
~The administration will be done once a day orally for 48 weeks.
~The usual recommended dose of atazanavir is 300 mg once daily with 100 mg of ritonavir once daily with food. Ritonavir acts by potentiating the pharmacokinetics of atazanavir."
16057310|NCT02473315|Other|cryotherapy|"The treatment arm :Whole body cryotherpy (WBC) (20 sessions of 3 minutes at a temperature of -110 degrees Celsius, on the basis of two sessions a day, spread over two weeks).
~The control arm : Whole body cryotherpy (WBC) (20 sessions of 1 minute at a temperature of -60 degrees Celsius, on the basis of two sessions a day, spread over two weeks)."
16057311|NCT02473302|Other|ham|160g per day during 4 days
16057312|NCT02473302|Other|ham + pomegranate extract|160g per day during 4 days
16057313|NCT02473302|Other|ham + tocopherol|160g per day during 4 days
16057314|NCT02473302|Other|rare sirloin steak|110g per day during 4 days
16057315|NCT02473302|Other|marinated rare sirloin steak|110g per day during 4 days
16061190|NCT02446574|Drug|Paclitaxel|starting dose 20mg/m2 qw
16057322|NCT02473263|Drug|Piperacillin tazobactam|Piperacillin/tazobactam 4g IV will be infused in the first 60 minutes, for nosocomial severe septic syndrome
16057323|NCT02473263|Drug|Norepinephrine|Norepinephrine will be infused after failure of hemodynamic optimization using vascular fluid loading
16057324|NCT02473263|Drug|Hydrocortisone|Hydrocortisone 100mg IV will be infused after failure of hemodynamic optimization using norepinephrine with at least 1.5mg/h
16057325|NCT02473250|Drug|Fluoxetine|Bipolar depressed patients will be treated with fluoxetine in combination with a mood stabilizer (valproate).
16057326|NCT02473250|Drug|Citalopram|Bipolar depressed patients will be treated with citalopram in combination with a mood stabilizer (valproate) if fluoxetine is not clinically warranted.
16057327|NCT02473237|Drug|indacaterol|Indacaterol, one inhales capsule, 150 mcgr, by dry powder dispositive
16057328|NCT02473237|Drug|Tiotropium|Tiotropium 18 mcgr, one inhaled capsule, by dry powder inhaler handihaler
16057329|NCT02473224|Biological|Norovirus GII.2 Challenge|GII.2 Snow Mountain Norovirus Filtrate. Cohort 1: 1.2x10^4 Genome Equivalent Copies (GEC) oral dose on Day 1. Cohort 2: either 1.2 x 10^2 GEC or 1.2 x10^6 GEC oral dose on Day 1, depending on the results of prior Cohort 1. Cohort 3: either 1GEC, 1.2 x 10^1 GEC, 1.2 x 10^2 GEC, 1.2 x 10^3 GEC, 1.2 x 10^5 GEC, or 1.2 x 10^6 GEC, or 1.2 GEC x 10^7 oral dose on Day 1, depending on the percentage of subjects with illness from Cohorts 1 and 2. Cohort 4: optimal dose of GEC as determined by the results of cohorts 1-3
16057330|NCT02473224|Other|Placebo|Placebo: 80 ml of sterile water for oral administration
16057331|NCT02473211|Drug|Sofosbuvir|Sofosbuvir 400 mg tablet administered once daily
16057332|NCT02473211|Drug|Daclatasvir|Daclatasvir 60mg tablet administered once daily
16057333|NCT02473198|Drug|Exparel|Prior to cementing of the prosthesis (minimum 20 minutes later), injection with mixture of 40 mL normal saline solution and 20mL 1.3% Exparel.
16057334|NCT02473198|Drug|Femoral Nerve Block Bupivacaine|The patient will then undergo an ultrasound guided femoral nerve block in the preoperative area with bupivacaine 0.25% 20 cc. All patients will undergo unilateral TKR using a medial parapatellar approach. Intraoperatively prior to cementing of the TKR, patients will also receive a local anesthetic injection of a mixture of 30cc 0.25% bupivicaine with epinephrine, 30mg of toradol and 10 mg of morphine sulfate into the posterior capsule of the knee joint.
16057335|NCT02473198|Drug|Toradol|The patient will then undergo an ultrasound guided femoral nerve block in the preoperative area with bupivacaine 0.25% 20 cc. All patients will undergo unilateral TKR using a medial parapatellar approach. Intraoperatively prior to cementing of the TKR, patients will also receive a local anesthetic injection of a mixture of 30cc 0.25% bupivicaine with epinephrine, 30mg of toradol and 10 mg of morphine sulfate into the posterior capsule of the knee joint.
16057336|NCT02473198|Drug|Morphine Sulfate|The patient will then undergo an ultrasound guided femoral nerve block in the preoperative area with bupivacaine 0.25% 20 cc. All patients will undergo unilateral TKR using a medial parapatellar approach. Intraoperatively prior to cementing of the TKR, patients will also receive a local anesthetic injection of a mixture of 30cc 0.25% bupivicaine with epinephrine, 30mg of toradol and 10 mg of morphine sulfate into the posterior capsule of the knee joint.
16057337|NCT02473185|Drug|Methylphenidate|Cross-over
16057338|NCT02473172|Device|Pressure Support ventilation|Assisted mechanical ventilation
16057339|NCT02473172|Device|Neurally Adjusted Ventilatory Assist|Assisted mechanical ventilation
16057340|NCT02473159|Drug|indocyanine green|As inject only indocyanine green (ICG), it provide the surgeon visual guidance to ensure better outcome.
16057341|NCT02473146|Drug|Gemtuzumab ozogamicin (GO)|
16057342|NCT02473133|Radiation|Personalized dose redistribution|Patients will receive an individualized radiotherapy prescription up to a total dose of 74 Gy given in 6.6 weeks if they have a positive FDG-PET at 42Gy. An initial dose of 50 Gy will be delivered in 5 weeks (single daily fractions of 2 Gy), then an additional dose up to 24 Gy will be delivered over 1.6 week.
16057343|NCT02473133|Radiation|No personalized dose redistribution|Patients will receive a single prescription of 66 Gy in 33 fractions in 6.6 weeks, with 2 Gy fractions given once daily, 5 days a week, without target volume reduction or adaptation (whatever the FDG-PET2 result).
16057344|NCT02473120|Biological|Determination of ESR1 mutations|Blood sample prelevement. Plasma issued from patient with metastatic breast cancer will be analysed at progression by Digital PCR to detect ESR1 mutations
16057345|NCT02473107|Other|Advanced caries lesions detection (no activity assessment)|The diagnosis strategy will based on detection of only moderate and advanced caries lesions (ICDAS scores 3 to 6). Initial caries lesions will be considered as sound surfaces. Caries activity status will not be evaluated. Clinical decision-making will be proposed for all lesions detected, based on evidence-based protocols.
16057346|NCT02473107|Other|All caries lesions detection (+activity assessment)|The diagnosis strategy will based on detection of initial, moderate and advanced caries lesions (ICDAS scores 1 to 6). Caries activity status will be also evaluated. Clinical decision-making will be proposed for all active lesions detected, based on evidence-based protocols. inactive caries lesions will not be treated.
16057347|NCT02473094|Drug|Capecitabine|Capecitabine 825mg/m2 bid, D1-D5 q7d
16057348|NCT02473094|Drug|Metformin|Metformin up to 2500mg/d
16057349|NCT02473094|Radiation|Radiotherapy|3D radiotherapy 50,4Gy divided in 25 fractions
16057350|NCT02473094|Drug|Placebo|Placebo up to 2500mg/d
16057351|NCT02473081|Behavioral|Minimal psychological intervention|Minimal psychological intervention (MPI) was used to help adults with chronic illness to manage their psychological burden by breaking through a negative spiral between thoughts and behaviors.
16057352|NCT02473081|Other|Usual care|Usual care was given by their family physicians.
16057353|NCT02473068|Device|CPAP|
16057354|NCT02473055|Other|Kangaroo Care|skin-to-skin, chest-to-chest placement of diaper clad preterm infant up against his mother's chest and covered by a receiving blanket folded into fourths for 2-3 hours from one feeding to the next.
16057355|NCT02473042|Procedure|Electrical Stimulation|Electrical stimulation to the wrist initiated at 1mHz, 1 pulse/second using two leads on a nerve stimulator. Stimulation continued throughout the breast surgery.
16057356|NCT02473042|Drug|Zofran|4 mg by vein for 1 dose.
16057357|NCT02473042|Drug|Dexamethasone|10 mg by vein for 1 dose.
16057358|NCT02473042|Drug|Phenergan|6.25 mg by vein for 1 dose.
16057359|NCT02473042|Drug|Pepcid|10 mg by vein for 1 dose.
16057360|NCT02473042|Behavioral|Questionnaire|Questionnaire completed about 15 minutes after participant wakes up after surgery, then every 30 minutes until they leave the clinic. It should take about 2 - 3 minutes to complete the questionnaire.
16057361|NCT02473029|Radiation|Vascular tomodensitometry|
16057362|NCT02473029|Other|Magnetic resonance angiography|
16057363|NCT02473029|Other|Vascular ultrasonography|
16057364|NCT02473029|Other|Retinal angiography|
16057365|NCT02473029|Other|Retinal optical coherence tomography|
16057366|NCT02473016|Drug|Carbon Dioxide Drug Delivery System (CDDS)|Doses will be administered to the nostril on the side of the trigeminal episode [ipsilateral nostril].
16057367|NCT02473003|Behavioral|high intensity exercise|high intensity exercise 80-90%
16057368|NCT02473003|Behavioral|low/medium intensity exercise|low/medium intensity exercise 40-50%
16057369|NCT02473003|Behavioral|Behavioral medicine strategies|Motivational and self-regulatory behavioral medicine support strategies
16057370|NCT02472990|Other|No drug and no placebo were used in this study|measures of muscular strength of legs, motor function, walk testing and analysis (3D video recording), RMI
16057371|NCT02472977|Drug|Ulocuplumab|
16057372|NCT02472977|Drug|Nivolumab|
16057373|NCT02472964|Biological|Trastuzumab|Trastuzumab 8mg/kg Iv over 90 minutes x 1 then Trastuzumab 6 mg/kg IV over 30 minutes every 3 weeks
16057374|NCT02472964|Biological|MYL- 1401O|MYL-1401O 8mg/kg Iv over 90 minutes x 1 then HERMyl 1401O Trastuzumab 6 mg/kg IV over 30 minutes every 3 weeks
16057375|NCT02472964|Drug|Paclitaxel|Paclitaxel 80mg/m2 IV over 60 minutes weekly.
16057376|NCT02472964|Drug|Docetaxel|Docetaxel 75mg/m2 IV over 60 minutes on day 1 of a 3 week cycle
16057377|NCT02472951|Other|Low carbohydrate meals|"Meal macronutritional energy composition:
~Carbohydrate 30% Protein 30% Fat 40%"
16057378|NCT02472951|Other|Standard carbohydrate meals|"Meal macronutritional energy composition:
~Carbohydrate 55% Protein 15% Fat 30%"
16057379|NCT02472938|Drug|dimethyl fumarate|dimethyl fumarate 120 mg capsules
16057380|NCT02472938|Other|Placebo|Placebo for BG00012
16057381|NCT02472925|Behavioral|MedSignals Pill Box|Pill box will provide feedback to the study team regarding subjects' compliance and provide reminders depending on Arm.
16057382|NCT02472912|Biological|BMO-2|Volunteers randomized in Treatment A will receive a single subcutaneous injection of BMO-2 (40mg / 0.8mL).
16057383|NCT02472912|Biological|EU-Humira|Volunteers randomized in Treatment B will receive a single subcutaneous injection of EU-Sourced Humira (40 mg / 0/8 mL)
16057384|NCT02472912|Biological|US-Humira|Volunteers randomized in Treatment C, will receive a single subcutaneous injection of US-sourced Humira (40 mg / 0.8 mL).
16057385|NCT02472899|Other|Blood sample|Non-interventional study based on blood samples taken at a single study visit
16057386|NCT02472886|Drug|LDV/SOF|90/400 mg FDC tablet administered orally once daily
16057387|NCT02472886|Drug|RBV|Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16057388|NCT02472873|Procedure|Aspiration and Sclerotherapy of endometriomas.|Aspiration and Sclerotherapy During Laparoscopy Using 95% Ethanol for the Treatment of Endometriomas
16057389|NCT02472873|Procedure|cystectomy of endometriomas.|cystectomy of endometriomas during laparoscopy
16057390|NCT02472873|Drug|Ethanol|
16057391|NCT02472860|Behavioral|Targeted Cognitive Training (TCT)|The investigators have selected a set of computer exercises designed to specifically target aspects of cognition relevant to autism spectrum disorder (including attention and executive functions). The tasks were designed to benefit subjects through principles of learning dependent plasticity.
16057392|NCT02472860|Other|Youth Appropriate Online Games|Engaging games not designed to improve cognition
16057393|NCT02472847|Drug|Dronabinol|Dronabinol (7.5mg) is administered only once by the oral route and is placed in opaque capsules with dextrose filler. Half of the participants will receive dronabinol.
16057394|NCT02472847|Drug|Placebo|Placebo is administered only once by the oral route and contains only dextrose in opaque capsules. Half of the participants will receive placebo.
16057395|NCT02472834|Dietary Supplement|Amino acid supplementation NephrAmine®|Dialysis patients will be randomized to receive either 250 mL of NephrAmine® (5.4% amino acids for injection; B. Braun Medical, Inc) containing ~14 grams of essential amino acids during each dialysis session (3 times weekly for 8 weeks) or no treatment (standard-of-care)
16057396|NCT02472821|Behavioral|Interactive youth educational program|Participation in a community-based face-to-face interactive youth educational program focusing on hearing health (i.e., noise hazards, risk of noise-induced hearing loss, mechanism of injury to the internal ear, and preventive measures)
16057397|NCT02472821|Behavioral|Internet-based educational booster|Visit to an educational Web site focused on hearing health
16057398|NCT02472808|Other|cTBNA without ROSE|Patients will undergo conventional TBNA and endobronchial biopsy and transbronchial lung biopsy
16057399|NCT02472808|Other|cTBNA with ROSE|Patients will undergo conventional TBNA with rapid on site evaluation of cytology smear and endobronchial biopsy and transbronchial lung biopsy
16057400|NCT02472808|Other|EBUS-TBNA without ROSE|Patients will undergo EBUS-TBNA and endobronchial biopsy and transbronchial lung biopsy
16057401|NCT02472808|Other|EBUS-TBNA with ROSE|Patients will undergo EBUS-TBNA with rapid onsite evaluation of cytology smear and endobronchial biopsy and transbronchial lung biopsy
16057402|NCT02472795|Drug|Matching placebo|One capsule of cenerimod to be taken once daily, irrespective of food intake. The capsule is to be swallowed whole. The capsule should be taken each day at approximately the same time (preferably each morning).
16057403|NCT02472795|Drug|Cenerimod|One capsule of cenerimod to be taken once daily, irrespective of food intake. The capsule is to be swallowed whole. The capsule should be taken each day at approximately the same time (preferably each morning).
16057404|NCT02472782|Drug|Teriparatide|The study will include patients from pre-defined groups of individuals (postmenopausal, male, and steroid-induced osteoporosis) who would any way receive teriparatide for their condition according to standard medical practice and Greek treatment guidelines
16057405|NCT02472769|Drug|IBP-9414|
16057406|NCT02472769|Drug|Placebo|Sterile water
16057512|NCT02472106|Device|Post-dilatation|Post-dilatation in self-expanding TAVI device procedures
16057407|NCT02472756|Drug|Chemotherapy|The choice of the chemotherapy regimen will be established on a per center basis, according to the standard in use in the country and in the center. Protocol does not specify any particular chemotherapy regimen.
16057408|NCT02472756|Drug|Rituximab|The choice of the rituximab regimen will be established on a per center basis, according to the standard in use in the country and in the center. Protocol does not specify any particular chemotherapy regimen.
16057409|NCT02472743|Device|Custom-built phototherapy lamp|Described in the arm description
16057410|NCT02472730|Device|Distal Attachment Cap|Colonoscopies are performed under the supervision of board certified attending gastroenterologists experienced in colonoscopy. Attending physicians will provide assistance at their discretion or at the request of the trainee. All close examinations for polyps will be carried out on withdrawal of the colonoscope.
16057411|NCT02472717|Drug|liraglutide|Liraglutide 0.6mg sc daily for 1 week, 1.2mg sc daily for 11 weeks
16057412|NCT02472717|Other|Placebo|Placebo sc daily for 12 weeks, volume titration at week 2 to mirror liraglutide arm
16057413|NCT02472704|Dietary Supplement|Gluten challenge|gluten (20 g/day) (identical powder sachets than placebo, mixed with meals) rechallenge while on a gluten-free diet
16057414|NCT02472704|Dietary Supplement|Placebo challenge|placebo (maltrodextrin) (identical powder sachets than gluten, mixed with meals) rechallenge while on a gluten-free diet
16057415|NCT02472691|Drug|Lenalidomide|Lenalidomide (investigational drug) will be added to standard of care (Aza and DLI) starting from day 1 for 21 days every 28 days for a maximum of 8 cycles. Starting dose of Lenalidomide 2.5 mg per day for the first 10 patients. If no dose limiting toxicity is identified in a first interim analysis, the next 10 patients will be treated with 5 mg per day. In case of no DLT after a second interim analysis, the remaining 30 patients are envisaged to be treated with 5 mg per day.
16057416|NCT02472691|Drug|Azacitidine|Starting on day 1 all patients will receive Azacitidine (standard of care) 75 mg/m2/d for 7 days every 28 days for up to 8 cycles.
16057417|NCT02472691|Biological|Donor Lymphocyte Infusions|DLIs will be given after cycle 4, 6 and 8 at a dose of 0.5-1x10^6 CD3/kg (1st DLI), 1-5x10^6 CD3/kg (2nd DLI) and 5-15x10^6 CD3/kg (3rd DLI).
16057418|NCT02472678|Other|Web-based tailored information and support system|Access to the web-based tailored information and support system (with a username/password)
16057419|NCT02472678|Other|Standard care|The control group will receive standard care.
16057420|NCT02472665|Drug|plasma-derived FVIII/VWF concentrate|1 single dose of 80 IU/kg VWF:RCo of Fanhdi will be administered
16057421|NCT02472652|Drug|Abilify Maintena|For subjects who meet inclusion/exclusion criteria for this study a switch from Palliperidone Palmitate or Risperidone injectable will be made to Abilify Maintena for a 3 month period to determine if there are changes in sexual dysfunction ratings over this time period
16057422|NCT02472639|Device|Ostom-i Alert Sensor|Wear the Ostom-i Alert Sensor
16057423|NCT02472639|Other|No Ostom-i Alert Sensor|Patient will not use device
16057424|NCT02472626|Drug|6,8-Bis(benzylthio)octanoic Acid|Given IV
16057425|NCT02472626|Drug|Cytarabine|Given IV
16057426|NCT02472626|Drug|Daunorubicin Hydrochloride|Given IV
16057427|NCT02472613|Device|acupuncture|"Patients will be treated at Renzhong（Du26）, Yintang（EX-HN3）、accupuncture Shangxing（DU23）penetrate to Baihui（DU20）,Sishencong（EX-HN1）; Neiguan（PC6）,Sibai（ST2）,Fengchi（GB20）and Sanyinjiao（SP6）in bilateral;Jianyu（LI15）,Quchi（LI11）,Shousanli（LI10）,Hegu（LI 4）, Fengshi (GB31),Xuehai（SP10） ,Zusanli（ST36）、Taichong（LR 3） of the hemiplegia side. There are another six groups of acupoints in bilateral. The acupuncturist will choose one group acupoints according to patients syndrome:Zhigou (SJ6),Qimen (LR14);Xingjian (LR2),Xiaxi(GB43);Fenglong (ST40),Lianquan(RN23);Tongli (HT5),Xinshu (BL15);Xinshu (BL15),Pishu(BL20);Shenshu (BL23),Taixi (KI3).
~The acupoints are inserted at the depth of 20-30mm except Renzhong（Du26）, Sibai（ST2）, Sishencong（EX-HN1）are inserted at the depth of 5-10mm. The needles will be left for 30 minutes and then removed. Acupuncture treatment will consist of three sessions per week for 12 consecutive weeks."
16057428|NCT02472613|Drug|placebo|Placebo was given for 12 consecutive weeks.
16057429|NCT02472613|Device|sham-acupoint acupuncture|"Jianliao（SJ14）,Tianquan（PC2）,Xiabai (LU4),Xiaoluo (SJ12),Shouwuli (LI13),Sidu (SJ9),Huizong (SJ7),Wenliu (LI7),Zhouliao (LI12),Quze（PC3）,Kongzui（LI6）,Zhigou（SJ6）,Zhongzhu（SJ3）,Futu（ST32）,Jimen (SP11),Yinshi (ST33),Liangqiu（ST34）,Shangjuxu（ST37）,Xiajuxu（ST39）,Xiyangguan（GB33）,Ligou（LR5）,Pucan (BL61),Jinggu (BL64),Rangu (KI2),Ligou (LR5),Neiting （ST44） of the hemiplegia side.
~• The acupoints are inserted at the depth of 20-30mm,except Pucan (BL61),Jinggu (BL64),Rangu (KI2) ,Neiting （ST44）are inserted at the depth of 5-10mm. The needles will be left for 30 minutes and then removed. Acupuncture treatment will consist of three sessions per week for 12 consecutive weeks."
16057430|NCT02472613|Drug|Fluoxetine|Fluoxetine was given at a dose of 20 mg/day for12 consecutive weeks.
16057431|NCT02472600|Drug|Colistin|
16057432|NCT02472600|Drug|Neomycin|
16057433|NCT02472600|Drug|Fecal microbiota transplantation (FMT)|FMT consist in the administration of fecal material obtained from healthy donors that has been diluted, homogenized, filtered and reconcentrated. In this study the processed fecal material will be frozen at -80°C after processing and will be administered to patients for up to six months after freezing via a nasogastric tube or via capsules.
16057434|NCT02472600|Drug|Omeprazole|Administered to inhibit gastric acid secretion before FMT administration if FMT administered via nasogastric tube approach (not used for capsule approach).
16057435|NCT02472587|Other|Questionnaire|
16057436|NCT02472574|Device|YL-1 type of intracranial hematoma puncture needle|YL-1 type of intracranial hematoma puncture needle(Pat. NO.is ZL：93244252•8) was originated by Beijing WanTeFu Medical Apparatus Co.Ltd in 1997. With integration of needle and bur drill it is designed as hard tunnel.By the technique of skull self-holding, the puncture needle can being fixed in the target of haematoma for several days.This technique is convenient, simple and safe. To position haematoma's location, drills 3 millimeter holes in the localization point of puncture, then insert the drainage tube to inhale hematoma, gives the filament resolver interrupted for liquefication drainage afterward.
16057437|NCT02472574|Drug|rt-PA|Up to 4 doses of 0.3~1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.
16057646|NCT02470962|Other|Observation|Observation by serial echocardiography with extended techniques and cardiac magnetic resonance imaging
16057438|NCT02472561|Other|Fitbit Physical Activity Monitor|Physical Activity: The study team will provide an individualized goal of total number of steps to attain daily and will be monitored using a Fitbit activity tracker. The total daily step goal will be reviewed by study staff and modified at weeks 4 and 8.
16057439|NCT02472561|Other|mHealth Glucometer|Blood Glucose: The participant will monitor their fasting blood glucose once per week by using an mHealth Glucometer and mobile app.
16057440|NCT02472561|Other|mHealth Blood Pressure|Blood Pressure: The participant will monitor their blood pressure once per week by using an mHealth Blood Pressure cuff and mobile app.
16057441|NCT02472548|Biological|DPX-RSV(A)|Prophylactic peptide vaccine targeting RSV will be administered intramuscularly.
16057442|NCT02472548|Biological|RSV(A)-Alum|Prophylactic peptide vaccine targeting RSV will be administered intramuscularly.
16057443|NCT02472548|Other|Placebo|Normal saline (0.9 % sodium chloride) will be administered intramuscularly.
16057444|NCT02472535|Other|Run-In Period: Placebo|2 capsules, once a day for two weeks
16057445|NCT02472535|Drug|MBX-8025 50 mg (Dose Escalation Period 1)|"1 capsule once a day for 4 weeks
~(MBX-8025 50 mg capsule)"
16057446|NCT02472535|Drug|MBX-8025 50 mg or 100 mg (Dose Escalation Period 2)|"1 capsule once a day for 4 weeks
~(MBX-8025 50 mg or 100 mg capsule)"
16057447|NCT02472535|Drug|MBX-8025 50 mg, 100 mg or 200 mg (Dose Escalation Period 3)|"1 or 2 capsules once a day for 4 weeks
~(MBX-8025 50 mg, 100 mg or two (2) 100 mg capsules)"
16057448|NCT02472522|Drug|Ropivacaine + Dexmedetomidine|Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine and 1 micrograms/kg dexmedetomidine (combination drug) diluted with 0.9% saline to a total volume of 40 ml (20 ml each side) for the TAP block
16057449|NCT02472522|Other|Ropivacaine|Patients satisfying inclusion criteria will receive Subarachnoid Block with Bupivacaine Heavy 0.5% (11 mg/2.2 ml) with 25 micrograms of fentanyl. At the end of the procedure, bilateral TAP block will be performed using Landmark Technique with 2.5 mg/kg of ropivacaine diluted with 0.9% saline to a total volume of 40 ml (20 ml each side)
16057450|NCT02472509|Drug|Ursodeoxycholic Acid|"Patients will be commenced on UDCA 15mg/kg/day (maximum dose 900mg/day) in 2-3 divided doses for 12 months.
~Patients who are unable to tolerate tablet medication will be started on UDCA syrup at the same dose."
16057451|NCT02472483|Behavioral|Cognitive and Behavior Therapy (CBT)|20-weeks CBT
16057452|NCT02472483|Behavioral|Mindfulness Based Cognitive Therapy (MBCT)|8-weeks MBCT
16057453|NCT02472470|Device|rTMS|Participants will receive 10 active TBS rTMS sessions once daily on weekdays for 2 weeks.
16057454|NCT02472457|Other|Crohn Disease Exclusion Diet|The CDED is divided into 4 stages: 0-6 weeks induction phase, weeks 7-12 step down phase, weeks 13-24 maintenance phase I, and weeks 25-52 maintenance phase II.
16057455|NCT02472457|Other|Free Diet|This diet contains no restrictions.
16057456|NCT02472431|Other|Intracavernosal administration of autologous ADRC|Subjects will undergo liposuction under local anesthesia. Lipoaspirate will be processed to isolate and concentrate adipose-derived regenerative cells (ADRC). After isolation autologous ADRC suspension will be injected intracavernosally.
16057457|NCT02472431|Procedure|Liposuction|
16057458|NCT02472431|Device|ADRC isolation|ADRC isolation performed using Celution 800/CRS System (Cytori Therapeutics Inc) according to manufacturer's protocol
16057459|NCT02472418|Drug|DFN-15 Dose A (treatment A)|DFN-15 Dose A administered
16057460|NCT02472418|Drug|DFN-15 Dose B (treatment B)|DFN-15 Dose B administered
16057461|NCT02472418|Other|Placebo (treatment C)|Placebo administered
16057462|NCT02472405|Device|595/1064nm Multiplex Laser|The multiplex cynergy laser will be used for this study. A third of the scar will solely be treated with the 595nm PDL.
16057463|NCT02472405|Device|595nm PDL|One third of the scar will be treated with 595nm PDL solely for 3 weeks (1 treatment session per week).
16057464|NCT02472392|Drug|Rabbit anti-thymocyte globulin|Active treatment
16057465|NCT02472392|Drug|Busulfan|comparitor
16057466|NCT02472392|Drug|Melphalan|comparitor
16057467|NCT02472392|Drug|Fludarabine|comparitor
16057468|NCT02472392|Drug|Cyclophosphamide|comparitor
16057469|NCT02472379|Behavioral|Writing: Group 1|Writing about experiences with familiar individuals in their lives, once a week for 6 weeks.
16057470|NCT02472379|Other|Writing: Group 2|Writing about experiences with familiar places, once a week for 6 weeks.
16057471|NCT02472366|Drug|ILUVIEN|
16057472|NCT02472353|Drug|Metformin|Metformin will begin to be administered prior to treatment with doxorubicin. Metformin will continue to be given throughout doxorubicin cycles until the completion of doxorubicin therapy.
16057473|NCT02472353|Drug|Doxorubicin|Standard of care treatment with doxorubicin
16057474|NCT02472340|Procedure|Muscle Biopsy|Muscle Biopsy
16057475|NCT02472327|Behavioral|Pre-operative support|
16057476|NCT02472314|Drug|1.3% Liposomal Bupivacaine|local tissue infiltration of Liposomal Bupivacaine during surgery
16057477|NCT02472314|Drug|0.125% Bupivacaine|Continues nerve block with Bupivacaine during surgery and postoperatively
16057478|NCT02472301|Dietary Supplement|cowpeas complementary food|cowpeas supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
16057479|NCT02472301|Dietary Supplement|corn-soy flour|Corn-soy flour supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
16057480|NCT02472301|Dietary Supplement|common bean complementary food|common bean supplementary food that will be approximately 15% of the calculated total daily intake. Children will receive the food for 12 months.
16057513|NCT02472093|Other|Physical exercises treatment|Includes different types of exercises: low-impact to moderate aerobic training; walking fast in a circle, alternating with periods of going up and down the stairs (3 steps for 10 minutes) for a total of 20 consecutive minutes; posture exercises for the back and proprioceptive exercises for the trunk in the supine position to improve axial stability, including diaphragmatic breathing. The heart rate was monitored through the use of a heart rate monitor, which allowed not to exceed the threshold.
16058385|NCT02465814|Drug|Ulipristal|Placebo (12 weeks), treatment break, Ulipristal 5 mg (12 weeks)
16057481|NCT02472288|Device|Electroacupuncture (EA)|The EA group receives 10 sessions of EA therapy (5 per a week, 2 weeks). After inserting needles by 5-10 mm (stainless steel, 0.25 mm in diameter and 4.0 mm in length, Dong Bang Acupuncture Inc., Korea) using the Park sham guide tube on the 8 points (BL31, BL32, BL33, and BL34, bilateral sides), de qi response is elicited. The electrical stimulation is then presented for 20 minutes by middle frequency (30 Hz) (STN-111, Stratek, Korea). Conventional treatments (western/traditional herbal medications, rehabilitation, or acupuncture without electro-stimulation for stroke, and western/traditional herbal medications or acupuncture without electro-stimulation for urinary retention) are allowed during the intervention period. The practitioner should have over 1-year clinical experiences.
16057482|NCT02472288|Device|Sham electroacupuncture|The patients in sham group receive totally 10 sessions of the sham EA (5 sessions per a week, for 2 weeks). Non-penetrating needles of Park sham device are implemented on the bilateral points of BL31, BL32, BL33, and BL34 (total 8 acupoints). Then, the electro-stimulation is presented for 20 minutes by middle frequency (30 Hz) (STN-111, Stratek, Korea), even though the electrical stimulation is not delivered through the skin. Conventional treatments for stroke and urinary retention along with EAT are not eliminated. It is also necessary for the practitioner with more than 1-year experiences on the clinical field.
16057483|NCT02472275|Drug|Antiandrogen Therapy|Undergo ADT with leuprolide acetate, goserelin acetate, or degarelix
16057484|NCT02472275|Other|Laboratory Biomarker Analysis|Correlative studies
16057485|NCT02472275|Drug|Multitargeted Tyrosine Kinase Inhibitor PLX3397|Given PO
16057486|NCT02472275|Radiation|Radiation Therapy|Undergo radiation therapy
16057487|NCT02472262|Dietary Supplement|Cow pea complementary food|A legume-based complementary food made from cowpeas will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.
16057488|NCT02472262|Dietary Supplement|Corn soy flour|Corn flour with 10% soy will be given for 6 months, 200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.
16057489|NCT02472262|Dietary Supplement|Common bean|A legume-based complementary food made from common beans will be given for 6 months,200 kcal/day for children 6-9 months old and 300 kcal/day for children 9-11 months old.
16057490|NCT02472249|Radiation|CT perfusion|Two dynamic CT perfusion acquisitions of the whole liver will be performed with a 320-detectors CT, prior and after to the norepinephrine injection.
16057491|NCT02472249|Drug|Norepinephrine intra-arteriel/hepatic|A small dose (24 ug) of norepinephrine will be injected in the hepatic artery over 10 seconds. The half-life of the drug is 90 seconds..
16057492|NCT02472236|Drug|PEX168|200µg,injected subcutaneously,once a week.
16057493|NCT02472236|Drug|Digoxin|0.5mg,oral,two times.
16057494|NCT02472223|Drug|Betadine 5%|"One time in-office administration (4-5 drops) of Betadine 5% limited to 2 minutes, followed by saline lavage.
~Betadine 5% exposure to the ocular surface is limited to 2 minutes in-office administration, followed by saline lavage per labeling instructions."
16057495|NCT02472223|Drug|Artificial Tears|One time in-office administration (4-5 drops) of artificial tears limited to 2 minutes, followed by saline lavage.
16057496|NCT02472210|Drug|Botulinum Toxin|An individualized dose will be injected in the painful limbs: up to 200 units in the upper limbs or up to 300 units in the lower limbs according to the average doses that subjects with PD pain in the limbs received in our clinic, as per our retrospective study. Each injection will contain 25 Units of Botulinum Toxin this way the number of injections will be from 1 to 8 for the upper limbs and from 1 to 12 in the lower limbs. The pattern of injections will be decided by the study investigator according to the localization. The involved muscles will be targeted using EMG guidance. of pain and will be the same at visit 2 and 3.
16057497|NCT02472197|Procedure|Hysteroscopic morcellation|The endometrial polyp is resected by a transcervical approach. During the procedure, the polyp is placed by suction against the window of the device, then cut by mechanical energy, in chips which are directly aspirated by the device.
16057498|NCT02472197|Procedure|Standard hysteroscopic resection|The endometrial polyp is resected by a transcervical approach in several chips using a mono or bipolar cove after distension of the uterine cavity under endoscopic control.
16057499|NCT02472184|Procedure|Office hysteroscopy|Office hysteroscopy is a procedure performed in the office in which a flexible hysteroscope is inserted into the uterine cavity. The patient is positioned in a dorsal lithotomy position and teh cervix is visualized with a speculum. Normal saline is used to distend the cavity, and the hysteroscope is used to visualize any abnormalities within the cavity.
16057500|NCT02472184|Procedure|Endometrial biopsy|An endometrial biopsy is a procedure in which a pipelle instrument is inserted into the uterine cavity and suction from the pipelle is used to obtain endometrial tissue. This is performed with the patient in the dorsal lithotomy position and a speculum is used to visualize the cervix.
16057501|NCT02472171|Dietary Supplement|High saturated fat meal, placebo powder and sunflower oil|High saturated fat meal with a blueberry flavored shake and sunflower oil
16057502|NCT02472171|Dietary Supplement|High saturated fat meal, blueberry powder and sunflower oil|High saturated fat meal with blueberry powder shake and sunflower oil
16057503|NCT02472171|Dietary Supplement|High saturated fat meal, placebo powder and DHA|High saturated fat meal with a blueberry flavored shake and DHA
16057504|NCT02472158|Device|chlorhexidine-gel-impregnated dressing|Chlorhexidine Patients receive a chlorhexidine-gel-impregnated dressing ( 3M Tegaderm CHG IV securement dressing™ ) after insertion of central venous catheter
16057505|NCT02472158|Device|Polyurethane film dressing|Polyurethane film dressing Patients receive a transparent polyurethane film dressing (3M Tegaderm IV dressing™) after insertion of central venous catheter.
16057506|NCT02472145|Drug|Decitabine 20 mg/m^2|Decitabine 20 milligram per square meter (mg/[m^2]) from Day 1, 2, 3, 4 and 5 of a 28-day cycle.
16057507|NCT02472145|Drug|Talacotuzumab 9 mg/kg|Talacotuzumab 9 milligram per kilogram mg/kg on Day 8 and 22 of a 28-day cycle.
16057508|NCT02472132|Device|POC US|Use of point of care ultrasound in insertion of CVC
16057509|NCT02472119|Dietary Supplement|rusks made of wheat flour enzymatically treated|100 g of rusks obtained from commercial wheat flour enzymatically treated with mTGasi and lysine ethyl ester, every day for 3 months
16057510|NCT02472119|Dietary Supplement|rusks made of wheat flour not enzimatically modified|100 g of rusks obtained from commercial wheat flour NOT enzymatically treated with mTGasi and lysine ethyl ester, every day for 3 months
16057511|NCT02472119|Dietary Supplement|Gluten-free diet|gluten-free diet
16057514|NCT02472093|Other|Perceptive Rehabilitation Treatment|therapeutic system that is based on the interaction between the patient's back or painful area and a support surface, composed of small latex cones with various dimensions (height: 3-8 cm; base diameter: 2-4 cm) and elasticities. The inferior bases of these cones are applied to a rigid wood surface using elastic strips.
16057515|NCT02472093|Other|Control group|The control group did brief educational sessions.
16057516|NCT02472080|Drug|gemcitabine -oxaliplatine combination|gemcitabine (2g/50mL)-oxaliplatine (200mg /40mL) combination, IV,every 2 weeks for 8cycles
16057517|NCT02472067|Behavioral|Psychologically - Based Physical Therapy|Psychologically - Based Physical Therapy targeting risk factors for disability.
16057518|NCT02472054|Drug|Alemtuzumab|
16057519|NCT02472054|Drug|Methyl Prednisolone (MP)|
16057520|NCT02472054|Drug|Cyclosporin A (CSA)|
16057521|NCT02472041|Device|Reanimator group|Resuscitator of Muller Group (intermittent positive pressure): Patients allocated to this group received intermittent positive pressure breathing (resuscitator Muller, Engemed, Brazil), adjusting the positive pressure around 1.5 kgf / cm2, which corresponds to 15 20 cm / H2O, positive pressure was applied through a face mask (Respironics®).
16057522|NCT02472041|Device|Control|Control Group: In position Fowler 45, patients assigned to this group was administered as treatment lung expansion exercises using the incentive inspiratory flow (Respiron, NCS, Mexico) and concomitantly blocking contralateral to the drain maneuvers were performed, compression / decompression associated with the incentive spirometry (Respiron) consisting of 4 sets of 10 active patient breaths with an interval of two minutes between sets. Since the load of the respiratory stimulator will be zero throughout treatment. Guidelines to the active, progressive and early mobilization.
16057523|NCT02472028|Other|blood pressure lowering algorithm|"The treatments used in the enhanced strategy arm are those proposed by national (HAS2013, SFHTA2013) and international (ESH 2013) recommendations, according to their Marketing Authorization and Summary of Product Characteristics : Diuretics, beta-blockers, Angiotensin Converting Enzyme inhibitors, Angiotensin Receptor Blockers, Calcium Channel Blockers Throughout the study, choice of drugs in each therapeutic class is left on the investigator's initiative. All drugs of these classes may be used , no specific drug is tested in this study."
16057524|NCT02472028|Other|usual strategy|The implementation of antihypertensive therapy the current recommendations to reach the blood pressure target in usual care. Throughout the study, choice of drugs in each therapeutic class is left on the investigator's initiative. Combinations of different pharmacological classes can be tested in order to find the most effective and best tolerated combinations.
16057525|NCT02472015|Procedure|telemedicine|psycho-behavioural care by telemedicine
16057526|NCT02472002|Biological|Mesenchymal cell therapy|"Name of the experimental cell preparation: Concentrated mesenchymal stem cells (MSCs) derived from autologous bone marrow
~Registry Type: autologous
~Qualitative and quantitative composition of the finished product: The product is a cell suspension consisting of mesenchymal stem cells (MSC) 40 x 106 MSC / ml suspended in human albumin (ALBUNORM ® 5% OCTAPHARMA France).
~Route of administration: endomyocardial injection
~Dose administered: 120-140 x106 MSC (mesenchymal stem cells)"
16057527|NCT02471989|Dietary Supplement|Low-FODMAP diet|
16057528|NCT02471989|Dietary Supplement|GERD diet|
16057529|NCT02471976|Other|strategy promoting early consideration and collegiate vulnerability of patients|One day training with the provision of vulnerability criteria inciting an early reflection of the level of therapeutic engagement; sheets available on the internet computer support collegial reflection and traceability of decisions to limit and stop treatments, incorporating the provisions of law known Leonetti
16057530|NCT02471963|Drug|Empagliflozin|
16057531|NCT02471963|Drug|Placebo|
16057532|NCT02471950|Procedure|2.5 % Isoflurane administration|Anaesthesia maintained during cardiopulmonary bypass with 2.5% isoflurane administered via the oxygenator of the bypass circuit.
16057533|NCT02471937|Biological|Bacteriological analyses on clinical samples performed with Eswabs|"Clinical samples analysed :
~mothervagina, breast milk, baby oral cavity, baby stool. Techniques: bacteriological cultures, Real time PCR"
16057534|NCT02471924|Other|Trans thoraciq cardiac ultrasonography|Establish a diagnosis power of the ΔITVAo ( aortic velocity peak )measured with cardiac Trans thoraciq ultrasonography after passiv leg rising to predict hypotension after spinal anesthesia for elective caesarean. Every patients participate for 30 minutes (time to perform the echography). Outside echographic evaluation, medical taking of participating patients will be exactly the same than what is done for all elective caesarean section.
16057535|NCT02471911|Drug|KPT-330|KPT-330 administered orally on days -5 and -3 prior to starting chemotherapy. Once chemotherapy starts, KPT-330 will be administered on days 1, 3, and 5 of each cycle. Dose levels will range from 20 mg to 100mg with a standard 3+3 escalation schema.
16057536|NCT02471911|Drug|Rituximab|IV Rituximab 375 mg/m2 on D1
16057537|NCT02471911|Drug|Etoposide|IV Etoposide 100 mg/m2 on D1-3
16057538|NCT02471911|Drug|Carboplatin|IV Carboplatin AUC 5 on D2
16057539|NCT02471911|Drug|Ifosfamide|IV Ifosfamide 5 g/m2 on D2
16057540|NCT02471911|Drug|Dexamethasone|20 mg qd on Days -5 and -3. 20 mg qd on Days 1-5
16057541|NCT02471898|Drug|HTX-011|
16057542|NCT02471898|Drug|Placebo|Saline
16057543|NCT02471885|Procedure|Remote Ischaemic Conditioning|each cycle of Remote Ischaemic Conditioning (RIC) consists of inflating a blood pressure cuff on the upper limb (arm) upto 200mm Hg (systolic BP + 20 mm Hg for low platelets, e.g. 50-150 x 10^9/L; skip RIC if platelets < 50 x 10^9/L) for 5 minutes, then deflated to 0 mm Hg for 5 minutes.
16057544|NCT02471885|Other|Placebo|Sham control blood pressure cuff placement at 10 mm Hg for 5 minutes, then deflated to 0 mm Hg for 5 minutes.
16057545|NCT02471872|Behavioral|Air Pollution Education|Students are presented with a one-hour interactive session on air pollution.
16057546|NCT02471872|Other|Non-Air Pollution Education|Students are presented with a one-hour interactive session on vaccines.
16057547|NCT02471859|Drug|GDC-3280|GDC-3280 at various doses, depending on the cohort and treatment period
16057548|NCT02471859|Drug|Placebo|Placebo at various doses, depending on the cohort and treatment period
16057549|NCT02471846|Drug|Atezolizumab|Participants will receive atezolizumab at a fixed dose of 1200 milligrams (mg) via intravenous (IV) infusion on Day 1 of each 21-day cycle with the exception of biopsy cohort A, where atezolizumab administration will start on Cycle 2 Day 1.
16057550|NCT02471846|Drug|GDC-0919|Participants will receive GDC-0919 by mouth (PO) twice daily (BID), specifically every 12 hours. During the dose-escalation stage, the first cohort will receive GDC-0919 at a starting dose of 50 mg PO BID. Dosing will commence on Day -1 for Cycle 1 and follow subsequent 21-day (Days 1 to 21) dosing cycles. The dose will be modified based upon evaluation of DLTs, with single dose escalations not to exceed 2.5-fold of the previous dose. The proposed dosages for evaluation are 50, 100, 200, 400, 600, and 1000 mg PO BID. During the expansion stage, selected solid tumor types will be treated at the MTD or MAD as determined during the dose-escalation stage.
16057551|NCT02471833|Drug|Telmisartan 20mg|Subjects will be given 20 mg of Telmisartan to be taken orally once a day before bedtime. Subjects will be on Telmisartan 20mg for a duration of 8 months.
16057552|NCT02471833|Drug|Telmisartan 40mg|Subjects will be given 40 mg of Telmisartan to be taken orally once a day before bedtime. Subjects will be on Telmisartan 40mg for a duration of 8 months.
16057553|NCT02471833|Drug|Placebo|Subjects will be given placebo to be taken orally once a day before bedtime. Subjects will be on placebo for a duration of 8 months.
16057554|NCT02471820|Drug|Lenalidomide|Lenalidomide 25 mg by mouth for the first 21 days of a 28-day-cycle for 4 cycles
16057555|NCT02471820|Drug|Adriamycin|Adriamycin as intravenous bolus infusion at a dose of 9 mg/m2, on days 1-4 of a 28-day cycle for 4 cycles
16057556|NCT02471820|Drug|Dexamethasone|Dexamethasone by mouth at a dose of 40 mg, on days 1, 8, 15, and 22 of a 28-day cycle for 4 cycles
16057557|NCT02471807|Device|Edwards FORMA Tricuspid Transcatheter Repair System|
16057558|NCT02471794|Behavioral|Personalized Health Planning Shared Medical Appointment|The PHP SMA group will combine personalized health planning with a modified version of the standard shared diabetes medical appointment. Modifications include: a self-assessment of health status, greater emphasis on a collaborative patient-provider health goal-setting process, a plan to meet goals, a mindfulness practice included in each session, and the creation of a 'personalized health plan' participant notebook for each individual to document health goals and track progress to review at each session. The participant notebook also includes educational handouts and worksheets to complement the educational curriculum
16057559|NCT02471781|Device|Zenith TX2 Low Profile TAA Endovascular Graft|Endovascular treatment of patients with aneurysms or ulcers of the descending thoracic aorta having morphology suitable for endovascular repair.
16057560|NCT02471768|Procedure|CORONARY ANGIOGRAM AND CENTRAL AORTIC WAVEFORM ANALYSIS|coronary angiogram
16057561|NCT02471755|Device|Eelectro-acupuncture|The bilateral acupoints of EX-CA1, ST25, SP6 and RN4 were selected for the treatment program.After regular disinfection,adhesive pads were placed on surface of all these acupoints. For RN4, EX-CA1, ST25, needles (0.30*75mm) were inserted into the points vertically throughout the pads, skin, fat tissue, and abdominal muscles until the participant had feeling of pricking. For SP6, needles were inserted into the acupoint to a depth of 1 cun,accompanied by manipulation of lifting, thrusting, and twisting 3 times. Electronic stimulator was connected to EX-CA1 and ST25 with dilatational wave, 10/50HZ, 0.1 to 1.0mA. The current intensity was adjusted to abdomen shivering without pain. Treatment lasted for 30 minutes and acupuncture manipulation for RN4 and SP6 were performed every 10 minutes.
16057562|NCT02471755|Device|Sham Eelectro-acupuncture|Non-acupoints approximate to RN4, ST25, EX-CA1 and SP6 were selected bilaterally, and adhesive pads were placed on the surface of selected non-acupoints' location. Blunt needles were inserted into the pads and to touch, rather than penetrate the surface of skin. Meanwhile, like EA group, manipulations of lifting, thrusting and twisting on non-acupoint approximate to RN4 and SP6 were performed 3 times. Sham Electronic stimulator was applied to the non-acupoint approximate to EX-CA1 and ST25, providing the outward appearance of the procedure in EA group but with no current intensity actually applied. Any other interventions were rigorously maintained the same as in the EA group.
16057563|NCT02471742|Procedure|NAC-sparing mastectomy|patients treated with mastectomy with conservation of nipple-areola complex
16057564|NCT02471742|Procedure|conventional mastectomy|patients treated with mastectomy without conservation of nipple-areola complex
16057565|NCT02471729|Device|EnligHTN™ Renal Denervation System|The renal nerve ablation will be performed according to the EnligHTN™ Renal Denervation System Instructions for Use. This system has the CE mark and is marketed in Europe and manufactured in France. The ablation catheter is indicated for use in renal denervation procedures for the treatment of hypertension.
16057566|NCT02471716|Biological|FPA008|FPA008 will be administered by IV infusion over approximately 30 minutes every 2 or 4 weeks
16057567|NCT02471703|Device|Total hip arthroplasty|Total hip arthroplasty
16057568|NCT02471690|Drug|Oritavancin|IV - Single dose 1200 mg Oritavancin
16057569|NCT02471690|Drug|Dextrose|D5W 5% in Water
16057570|NCT02471677|Drug|Elonva|corifollitropin alfa (Elonva): a single injection 100 or 150 ug (depending on patient body weight) on Day 2/3 of menstrual cycle
16057571|NCT02471677|Drug|Puregon|follitropin beta (Puregon): daily injections 150 IU from Day 2/3 of menstrual cycle until adequate follicle development is achieved
16057572|NCT02471664|Device|Mitral Loop Cerclage Annuloplasty|
16057573|NCT02471651|Drug|Dexamethasone intravitreal implant (0.7 mg)|Subjects with persistent DME who are randomized to this arm may get up to 3 treatments with the implant (0.7 mg dexamethasone).
16057574|NCT02471651|Drug|Intravitreal anti-VEGF injection|This injection may be ranibizumab, bevacizumab, or aflibercept.
16057575|NCT02471638|Device|PQ Bypass System for Femoropopliteal Bypass|To access, deliver guidewires and implant stent grafts for a percutaneous fem-pop bypass.
16057576|NCT02471625|Device|ClearView Scanning|
16057577|NCT02471599|Procedure|tonsillectomy|The tonsillectomy will be performed by the otolaryngologist. In addition, all subjects will receive the conventional drug treatments, defined as treatment of participants using the angiotensin-converting enzyme inhibitor (ACEi)/angiotensin II receptor blocker (ARB), anticoagulants, antihypertensives, corticosteroids so on, according to individual status.
16057578|NCT02471599|Other|non-tonsillectomy|The non-tonsillectomy group received conventional drug treatments defined as treatment of participants using the ACEi/ARB,Anticoagulants, Antihypertensives, corticosteroids and so on, according to individual status.
16057579|NCT02471586|Procedure|Coronary PCI guided by IVUS|Imaging type
16057580|NCT02471586|Procedure|Coronary PCI guided by OCT|Imaging type
16057581|NCT02471586|Procedure|Coronary PCI guided by Angiography|Imaging type
16061191|NCT02446574|Drug|Cisplatin|dose 25mg/m2 qw
16057582|NCT02471573|Procedure|Freeze-all protocol|Embryos are selected for cryopreservation using vitrification technique. Two vitrified embryos will be warmed and transferred in subsequent cycle.
16057583|NCT02471573|Procedure|Fresh transfer protocol|Two embryos are selected and transferred fresh in the same cycle.
16057584|NCT02471560|Drug|dimethyl fumarate|As per the prevailing local label.
16057585|NCT02471560|Drug|injectable MS DMT|As described above.
16057586|NCT02471547|Other|BWT with Mitomycin-C prior TURBT|"Participants will randomly assign, according to random computerized software, to those who receive the heated thermo-chemo therapy and those who will not. The intravesical instillation will take place up to 6 hours prior TURBT in the following matter: The Elmedical BWT system will introduce intravesically a 40mg of heated Mitomycin MMC, diluted in 50cc of saline at a uniform temperature (44-44.50C). The length of the procedure - 50 minutes"
16057587|NCT02471534|Procedure|abdominal compression|When there are clinical signs of hypovolemia, such as hypotension, decreased urine output and central venous pressure less than 5 mmHg, right upper abdomen is gently compressed for 10 seconds. Changes of blood pressure are continuously recorded during this period. About 3 min later, intravenous colloid fluid 10 mL/kg is infused for 20 min.
16057588|NCT02471521|Other|Mask ventilation|Mask ventilation is performed after administration of rocuronium or not. Initial inspiratory pressure is set as 10 cmH2O and increased gradually by 2 cmH2O until gastric insufflation is detected by either of two methods. Tracheal intubation is done after detection of gas.
16057589|NCT02471521|Drug|Rocuronium|Rocuronium 0.6 mg/kg is injected before mask ventilation in muscle relaxant group or after finish of study in non-relaxant group.
16057590|NCT02471508|Device|Body-mapping Tank-top Embedded with Biofeedback System|In this study, the eligible subjects will be given tailor-made tank-top embedded with biofeedback system to wear it 8 hours daily. Monitor, observation and additional posture training sessions will be provided during the 6 months wearing period. The effectiveness of the biofeedback tank-top will be evaluated by pre-and post- treatment ultrasonic imaging device (measuring the angle of the spine) and electromyography muscle signal
16057591|NCT02471495|Device|Synergo® RITE + MMC|"Synergo® system delivers homogenous microwave hyperthermia to the bladder wall in combination with bladder instillation of cold chemotherapeutic agent - Mitomycin C (MMC).The energy-delivering unit and the intravesical irrigation system are computer-controlled, The irrigation system consists of a disposable tubing line and catheter set. The catheter is a triple-lumen, silicone, transurethral Foley-type catheter.
~MMC is constituted as a powder (40 mg) dissolved in 50 ml sterile water for injection."
16057592|NCT02471482|Other|Mozart music lullaby|Recorded Mozart Lullaby will be played. The noise level will be kept below 45db as recommended by American Academy of Pediatrics and will be monitored by sound monitor placed in incubator during the study period. Enrolled babies will have hearing screening performed prior to discharge from hospital.
16057593|NCT02471469|Drug|Enzalutamide, 160mg, 40 mg soft capsules, once daily|Exclusively determine pharmacokinetics and pharmacodynamics of enzalutamide for the indication according to the drug label
16057594|NCT02471456|Other|Quality of Life Questionnaire|Quality of Life Questionnaire will be completed at least 1 year after their surgery.
16057595|NCT02471456|Other|MACCE review|MACCE will be assessed by contacting the patient's GP and/or Cardiologist at least 1 year after their surgery.
16057596|NCT02471443|Procedure|Surgery for severe endometriosis|Consecutive patients undergoing excisional surgery for severe endometriosis with bowel involvement
16057597|NCT02471430|Drug|Panobinostat|Panobinostat will be administered orally.
16057598|NCT02471430|Drug|Pegylated Interferon-alpha2a|Pegylated Interferon-alpha2a will be administered subcutaneously in one shot.
16057599|NCT02471417|Dietary Supplement|Dietary nitrate|140ml of nitrate rich beetroot juice provides 12.9mmol nitrate and will be on a single occasion by the study subjects.
16057600|NCT02471417|Dietary Supplement|Placebo|140ml of nitrate depleted beetroot juice provides 0.5mmol nitrate and will be on a single occasion by the study subjects.
16057601|NCT02471404|Drug|Dapagliflozin|10 mg, orally Green, plain, diamond-shaped, film-coated tablet
16057602|NCT02471404|Drug|Saxagliptin|5 mg, orally Plain, yellow, biconvex, round, film-coated tablet
16057603|NCT02471404|Drug|Glimepiride|1, 2, or 4 mg, orally Opaque gray capsule
16057604|NCT02471404|Drug|Placebo for dapagliflozin|Does not contain active ingredient, orally Green, plain, diamond-shaped, film-coated tablet
16057605|NCT02471404|Drug|Placebo for saxagliptin|Does not contain active ingredient, orally Plain, yellow, biconvex, round, film-coated tablet
16057606|NCT02471404|Drug|Placebo for glimepiride|Does not contain active ingredient, orally. Opaque gray capsule
16057607|NCT02471391|Drug|ABT-199|
16057608|NCT02471391|Drug|Ibrutinib|
16057609|NCT02471339|Behavioral|Acceptance and Commitment Therapy (ACT)|Acceptance and Commitment Therapy (ACT), a newer generation of cognitive-behavioral therapy, focuses on encouraging individuals to engage in more adaptive ways of coping with pain.
16057610|NCT02471326|Biological|VRC-HIVMAB060-00-AB (VRC01)|A potent HIV-specific monoclonal antibody
16057611|NCT02471313|Drug|[18F] FMISO|[18F] Fluromisonidazole, 1 h-(3-[18F]-fluro-2hydroxyl-propy10-2-nitro-imidazaole is an investigational positron emission tomography (PET) radiopharmaceutical for injection and used to visualize hypoxia imaging agent. Each patient will receive up to 10 mCi of [18F] FMISO PET imaging post TACE procedure.
16057612|NCT02471274|Drug|sotagliflozin|single 400 mg dose
16057613|NCT02471248|Device|Ankle Robot with Power Assistance|"Stroke patients will enrol in a 20-session gait training program for at least two sessions per week. In each session, the stroke patient will walk overground continuously for 2 * 10 minutes and walk up/down a staircase (about 10 steps per flight) for 10 minutes, rest will be provided in between each round of walking or stair climbing. This training can promote gait recovery and physical fitness.
~They will wear the Ankle Robot during the gait training. The motor will synchronise with the paretic-side gait pattern to provide dorsiflexion moment during swing phase, and free the ankle joint when the sole is loaded."
16057642|NCT02471014|Other|Questionnaires|"All participants will answer the following questionnaires:
~UCLA Loneliness Scale Questionnaire will be used to measure a difference between the groups.
~Perceived Stress Scale-10 Questionnaire will be used to measure a difference between the groups.
~Interpersonal Support Evaluation List-12 will be used to measure a difference between the groups Life Orientation Test-Revised will be used to measure a difference between the groups."
16057614|NCT02471248|Device|Sham|"Stroke patients will enrol in a 20-session gait training program for at least two sessions per week. In each session, the stroke patient will walk overground continuously for 2 * 10 minutes and walk up/down a staircase (about 10 steps per flight) for 10 minutes, rest will be provided in between each round of walking or stair climbing. This training can promote physical fitness.
~They will wear the Ankle Robot during the gait training. The robot will synchronise with the paretic-side gait pattern to the Ankle Robot provides very low assistance which can be barely perceived by the stroke patient but does not suffice to support the ankle dorsiflexion."
16057615|NCT02471235|Behavioral|Physiotherapy|Pulmonary rehabilitation
16057616|NCT02471222|Drug|ADS-5102|Oral capsules to be administered once daily at bedtime for 4 weeks
16057617|NCT02471222|Other|Placebo|Oral capsules to be administered once daily at bedtime for 4 weeks
16057618|NCT02471209|Drug|Sevoflurane|general anesthesia with 2% followed by 3% sevoflurane
16057619|NCT02471196|Drug|ORM-12741|ORM-12741 low dose twice a day
16057620|NCT02471196|Drug|ORM-12741|ORM-12741 high dose twice a day
16057621|NCT02471196|Drug|Placebo|Placebo twice a day
16057622|NCT02471183|Drug|Selexipag|Tablets for oral administration containing 200 micrograms (mcg) of selexipag to be administered twice a day. The individual dose is to be established during the first 12 weeks of the study. Doses are in the range from 200 micrograms (1 tablet) to 1,600 micrograms (8 tablets).
16057623|NCT02471157|Other|Observation|
16057624|NCT02471144|Biological|Experimental : Secukinumab low dose|Depending on weight group subject will receive per dose a) 75 mg if weighing less than 50 kg b) 150 mg if weighing 50 kg or more. Secukinumab injections (one or two per dose, depending on the weight group) will be administered subcutaneously at Randomization, Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48, and Placebo secukinumab at Weeks 13, 14 and 15 during the blinded phase of the study; thereafter at Week 52 and every 4 weeks during the extension treatment period until Week 232.
16057625|NCT02471144|Biological|Experimental: Secukinumab high dose|Depending on weight group subject will receive per dose a) 75 mg if weighing less than 25 kg b) 150 mg if weighing between 25 and less than 50 kg c) 300 mg if weighing more than 50 kg. Secukinumab injections (one or two per dose, depending on the weight group) will be administered subcutaneously at Randomization, Weeks 1, 2, 3, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48, and Placebo secukinumab at Weeks 13, 14 and 15 during the blinded phase of the study; thereafter at Week 52 and every 4 weeks during the extension treatment period until Week 232.
16057626|NCT02471144|Biological|Placebo Comparator: Secukinumab Placebo|Placebo secukinumab (one or two subcutaneous injections per dose, depending on weight group) at Randomization and Weeks 1, 2, 3 4 and 8. At Week 12, subjects in the placebo group based on their PASI 75 response status at Week 12 will proceed as follows: • PASI 75 responders will discontinue study treatment at Week 12 and enter the treatment-free follow-up period • PASI 75 non-responders will receive high dose or low dose secukinumab, according to the pre-assignment at the Randomization visit. They will receive their treatment based on the weight category(<25 kg, 25- <50kg, ≥50 kg), on Weeks 12, 13, 14, 15, and then every four weeks starting at Week 16 until Week 48 during the maintenance period; thereafter at week 52 and every 4 weeks during the extension treatment period until Week 232.
16057627|NCT02471144|Biological|Active Comparator: Etanercept|Etanercept 0.8 mg/kg of subject weight and up to a maximum of 50 mg per dose. Subcutaneous etanercept 0.8 mg/kg (one or two injections per dose) once per week, for 51 weeks administered at home (self-injected or by caregiver) or at the study site. At Wk 52 subjects in the etanercept group will move into the treatment-free follow up period and terminate the study.
16057628|NCT02471131|Device|WATCHMAN Device implantation|The implantation of the device will be done into the left atrial appendage according to the guidelines.
16057631|NCT02471105|Drug|Preserved Bimatoprost 0.01%|Eye drops solution Topical use Once in the evening 3 months
16057632|NCT02471105|Drug|Tafluprost Unit Dose Preservative Free 15microgram/ml|Eye drops solution Topical use Once in the evening 3 months
16057633|NCT02471092|Other|Skim milk products|Milk treatments will be served with 58g of breakfast cereal.
16057634|NCT02471079|Radiation|Radiotherapy|
16057635|NCT02471066|Device|rTMS|"Study 1 : 5 daily sessions of rTMS 1 Hz, 95% x resting motor threshold (RMT) applied on M1 / sham
~Study 2 : 3 weekly sessions of rTMS 1 Hz, 95% x RMT on M1 combined with ericksonian hypnosis session"
16057636|NCT02471053|Other|Moderate Intensity Exercise|Exercise sessions will be held twice-weekly and will begin with a group warm-up activity, followed by 45 minutes of aerobic activity and ending with a cool down. All aerobic exercise will be performed at a moderate intensity, defined as exercise that elicits a heart rate (HR) between 40-60% of heart rate reserve (HRR). Prior to the initial exercise session target heart rates will be calculated for each subject based on the maximum HR achieved during their baseline stress test.
16057637|NCT02471040|Drug|Beta-hydroxybutyrate|Both healthy subjects and type 1 diabetic subjects will receive a bolus-continuous infusion of 40umol/min/kg of BHB for 5 min, followed by a 12µmol/min/kg of BHB or infusion of a comparable volume of normal saline (placebo) to control for possible volume effects for the remainder of the study.
16057638|NCT02471040|Other|Normal Saline|Both healthy subjects and type 1 diabetic subjects will receive a bolus-continuous infusion of 40umol/min/kg of BHB for 5 min, followed by a 12µmol/min/kg of BHB or infusion of a comparable volume of normal saline (placebo) to control for possible volume effects for the remainder of the study.
16057639|NCT02471027|Procedure|Neoadjuvant chemotherapy|There is no uniform schemer,commonly used drugs including carboplatin,cisplatin,paclitaxel,vincristine,bleomycin,fluorouracil,ifosfamide,mitomycin,gemcitabine,and so on.Methods including intravenous chemotherapy and artery intervention chemotherapy,also has not been unified.
16057640|NCT02471014|Drug|Pneumovax 23|All participants will receive a single 0.5 mL Pneumovax 23 intramuscular vaccine at baseline.
16057641|NCT02471014|Other|Blood tests|All participants will have two 50 milliliter blood draws: at baseline and up to 6 weeks later.
16057643|NCT02471001|Biological|Blood samples|Two additional blood samples will be taken from in-situ catheters during heart surgery.
16057644|NCT02470988|Behavioral|Cognitive Behavioural Analysis System of Psychotherapy|
16057645|NCT02470988|Behavioral|CBASP Without DPI|
16061192|NCT02446574|Radiation|Radiation|60Gy/2Gy/30f
16057647|NCT02470949|Behavioral|Low Social Status|The participants will be randomized to the Low Social Status Condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit.
16057648|NCT02470949|Behavioral|High Social Status|The participants will be randomized to the High Social Status Condition. On their second visit, they will undergo the condition in which they were not randomized to on their first visit.
16057649|NCT02470936|Behavioral|Lifestyle intervention|Patients will have access to the lifestyle website and an activity monitor (e.g., Fitbit), receive texts, and be provided with individualized lifestyle recommendations.
16057650|NCT02470923|Drug|Nicotine replacement therapy|
16057651|NCT02470923|Behavioral|Intensive counseling|
16057652|NCT02470923|Behavioral|Medical advice|
16057653|NCT02470910|Device|Magnetic Resonance Imaging|
16057654|NCT02470897|Radiation|Radiation Therapy Treatment Planning and Simulation|Undergo urethral-sparing IMRT planning
16057655|NCT02470897|Radiation|SBRT|Undergo moderate dose SBRT with SIB
16057656|NCT02470897|Radiation|SBRT|Undergo uniform dose SBRT
16057657|NCT02470884|Device|Boston Scientific Fully Absorbable Scaffold|Attempt to implant the Boston Scientific Fully Absorbable Scaffold.
16057658|NCT02470871|Biological|Eptacog alfa (activated) or pdFVII|"Comparator Drug 1: Recombinant activated FVII (rFVIIa). Subjects with eptacog alfa (activated) as their routine FVII replacement therapy will receive a single dose of eptacog alfa (activated) in the study.
~Comparator Drug 2: Plasma-derived FVII (pdFVII). Subjects with pdFVII as their routine FVII replacement therapy will receive a single injection of pdFVII in the study."
16057659|NCT02470871|Biological|CSL689|Experimental Drug: Recombinant fusion protein, linking activated FVII with albumin (rVIIa-FP). Subjects will receive a single dose of CSL689 at either a low dose (Arm 1) or a high dose (Arm 2)
16057660|NCT02470858|Drug|LDV/SOF+ASV|Ledipasvir/sofosbuvir (LDV/SOF) 90 mg/400 mg fixed-dose combination (FDC) tablet; administered orally once daily; Asunaprevir (ASV) 200mg, administered orally twice daily.
16057661|NCT02470858|Drug|SOF+DCV+SMV|Sofosbuvir (SOF) 400 mg tablet administered orally once daily; Daclatasvir (DCV) 60 mg tablet administered orally once daily; Simeprevir (SMV) 150 mg tablet orally once daily.
16057662|NCT02470858|Drug|SOF+DCV+ASV|Sofosbuvir (SOF) 400 mg tablet administered orally once daily; Daclatasvir (DCV) 60 mg tablet administered orally once daily; Asunaprevir (ASV) 200mg, administered orally twice daily.
16057663|NCT02470845|Drug|herbal patches of Tian Jiu group|The formula of herbal patch consists of BaiJieZi (Sinapis Semen), Yan Hu Suo（CorydulisRhizoma）、ZhiGan Sui (Kansui Radix)、Xi Xin (Asari Radix et rhizama) and Rengong She xiang(Moschus Artifactus) . The four herbs will be ground into powder, mixed thoroughlywith 20% BaiJieZi (Sinapis Semen), 25% Yan Hu Suo（CorydulisRhizoma), 15% ZhiGan Sui (Kansui Radix), and 40% Xi Xin (Asari Radix et rhizama), and the mixed powder will mix with fresh ginger juice in the ratio of 20g to 25 ml. The mixture will be made to a patch weighted as 2g and 1cm*1cm round size. 0.02g artificial She Xiang (Moschus Artifactus) will be added on top of each patch. Each patch will be applied on one acupoint.
16057664|NCT02470845|Drug|placebo patches of placebo-control group|The placebo patch consists of flour and edible pigments. These two ingredients will be mixed with water and made to patches weighted as 2g and 1cm*1cm round size.Each patch will be applied on one acupoint.
16057665|NCT02470832|Drug|RG1662|
16057666|NCT02470832|Drug|itraconazole|
16057667|NCT02470819|Genetic|Genetic profiling|genetic profiling
16057668|NCT02470806|Device|PICO System|Negative Pressure Wound Therapy (NPWT) at 80mmHg (nominal) +/- 20 mmHg to the wound surface
16057669|NCT02470806|Device|tNPWT System|NPWT from -25 mmHg and up to -200 mmHg; intensity settings of either low, medium and high; delivery modes of continuous or intermittent. The pressure, intensity and delivery settings will be left to the Investigator's discretion at each study treatment visit.
16057670|NCT02470793|Procedure|Descemet Stripping Automated Endothelial Keratoplasty|Descemet Stripping Automated Endothelial Keratoplasty
16057671|NCT02470793|Procedure|Descemet Membrane Endothelial Keratoplasty|Descemet Membrane Endothelial Keratoplasty
16057672|NCT02470780|Drug|Rifaximin|Rifaximin is an antibiotic used to treat SIBO. It is a 7-day course of treatment followed by three or six months of follow-up. This is a placebo-controlled study designed so that all participants will receive the active drug at least once during the study.
16057673|NCT02470780|Drug|Placebo|Placebo matching Rifaximin treatment.
16057674|NCT02470767|Drug|Direct Oral Anticoagulant (DOAC)|Treatment pattern following the summary of product characteristics
16057675|NCT02470754|Device|Tobacco Cigarette|Usual brand tobacco cigarette smoked by study participant.
16057676|NCT02470754|Device|Electronic Cigarette|Usual brand electronic cigarettes smoked by study participant.
16057677|NCT02470741|Drug|Letrozole|
16057678|NCT02470741|Other|Placebo|
16057679|NCT02470728|Other|New Clinical Pathway|
16057680|NCT02470715|Genetic|Molecular profile|Patients and their treating physician will obtain the patient's genetic risk assessment
16057681|NCT02470702|Drug|Oritavancin|
16057682|NCT02470702|Drug|Placebo (D5W)|
16057683|NCT02470689|Drug|Diacerin cream|Diacerin tablet solubule in ultraphil cream
16057684|NCT02470676|Device|Pessary|Two optional pessary sizes with the following dimensions: 65/17/35 or 70/17/35 and 200 mg daily progesterone vaginal suppositories (Utrogestan)
16057685|NCT02470676|Drug|Progesterone|200 mg daily of vaginal progesterone suppositories (Utrogestan)
16057686|NCT02470663|Dietary Supplement|DENSITYTM caplets (marketed as Amorphical)|supplementation
16057687|NCT02470663|Dietary Supplement|Calcium carbonate 600 mg once daily|supplementation
16057688|NCT02470650|Drug|elvitegravir/cobicistat/emtricitabine/tenofovir|1 recovered tablet once Per day ● Specify total dose (number and unit): 150 mg de elvitegravir, 150 mg cobicistat, 200 mg emtricitabine , 245 mg tenofovir disoprox milligram(s)
16057689|NCT02470650|Drug|Darunavir|Darunavir 800 mg (Prezista®) 1 recovered tablet 800 mg once a day
16057690|NCT02470650|Drug|abacavir/lamivudine|Abacavir 600 mg /lamivudine 300 mg recovered tablet once a day
16057691|NCT02470650|Drug|Ritonavir|Ritonavir 100 mg recovered tablet once a day
16057692|NCT02470650|Drug|Lamivudine|lamivudine 300mg (Epivir) 1 recovered tablet
16057693|NCT02470650|Drug|rilpivirine|rilpivirine (Edurant®) 1 recovered tablet 25 mg. once a day
16057694|NCT02470637|Drug|SAR439065|"Pharmaceutical form:dry powder insulin
~Route of administration: inhalation"
16057695|NCT02470637|Drug|Insulin lispro|"Pharmaceutical form:solution for injection
~Route of administration: subcutaneous"
16057696|NCT02470624|Other|treatment following current guideline|
16057697|NCT02470611|Drug|Sodium alendronate|After manual quadrant-wise scaling and root planing, at the final treatment appointment the randomized selected periodontal site (showing pocket depth ≥ 5mm, clinical attachment loss > 3mm and proximal bone defects) received 1% sodium alendronate gel
16057698|NCT02470611|Other|Placebo|After manual quadrant-wise scaling and root planing, at the final treatment appointment the randomized selected periodontal site (showing pocket depth ≥ 5mm, clinical attachment loss > 3mm and proximal bone defects) received 1% placebo gel
16057699|NCT02470598|Other|Treatment with Adapted Automated Peritoneal Dialysis (aAPD)|This is a purely non-interventional, observational study, where treatment decisions are completely guided by the discretion of the attending nephrologists
16057700|NCT02470585|Drug|Veliparib|Capsules for oral administration
16057701|NCT02470585|Drug|Paclitaxel|Administered by intravenous infusion, either 80 mg/m² of body-surface area (BSA) on Days 1, 8, and 15 of each 21-day cycle (weekly dosing), or 175 mg/m² of BSA on Day 1 of each 21-day cycle (3-week dosing).
16057702|NCT02470585|Drug|Carboplatin|Administered by intravenous infusion at an area under the curve (AUC) of 6 mg/mL/min every 3 weeks.
16057703|NCT02470585|Other|Placebo to Veliparib|Capsules for oral administration
16057704|NCT02470572|Other|Omnyx™ IDP system|Omnyx™ IDP system for Whole Slide Images (WSI)
16057705|NCT02470572|Other|Conventional light microscope|Conventional light microscope
16057706|NCT02470559|Biological|Aldesleukin|Given SC
16057707|NCT02470559|Biological|HER2Bi-Armed Activated T Cells|Given IV and IP
16057708|NCT02470559|Other|Laboratory Biomarker Analysis|Correlative studies
16057709|NCT02470559|Biological|Sargramostim|Given SC
16057710|NCT02470546|Drug|Metformin|Metformin 1000mg twice a day
16057711|NCT02470546|Drug|Placebo|Placebo 1000mg twice a day
16057712|NCT02470533|Radiation|Radiation therapy|6 fractions of 8-9Gy
16057713|NCT02470533|Device|chemoembolization|Up to 4 sessions
16057714|NCT02470520|Procedure|CRRT|continuous renal replacement therapy
16057715|NCT02470507|Other|AKI|development of immune dysregulation and rise in inflammatory markers and activation of immune cells
16057716|NCT02470494|Device|Sound amplification provided via the EarLens CHD|Subjects with mild to severe hearing impairment receiving sound amplification treatment with EarLens CHD.
16057717|NCT02470481|Other|No Intervention|This is an obervational study
16057718|NCT02470468|Biological|DCVAC add on to SOC|DCVAC add on to SOC (Carboplatin, Paclitaxel): until progression or intolerance or death
16057719|NCT02470468|Biological|DCVAC and immune enhancers add on to SOC|DCVAC +/- immune enhancers (Interferon-α and Hydroxychloroquine) add on to SOC (Carboplatin, Paclitaxel): until progression or intolerance or death
16057720|NCT02470468|Other|Standard of Care Chemotherapy|SOC (Carboplatin, Paclitaxel): until progression or intolerance or death
16057721|NCT02470455|Drug|Atorvastatin|Some patients were receiving 20 mg of Atorvastatin wheras others were on a higher dose of 40-80mg daily. Patients were taking statins for either dyslipidemia, or primary or secondary prevention of cardiovascular disease.
16057722|NCT02470442|Drug|Sevoflurane/Desflurane|Anesthesia induced with sevoflurane and anesthetic maintenance with desflurane
16057723|NCT02470442|Drug|Sevoflurane|Anesthesia induced with sevoflurane and anesthetic maintenance with sevoflurane
16057724|NCT02470429|Device|SYSTANE HYDRATION lubricant eye drops|Preserved with POLYQUAD (polidronium chloride) 0.001%
16057725|NCT02470429|Device|Hyabak 0.15% eye drops|Preservative-free
16057726|NCT02470429|Drug|0.9% saline eye drops|Preservative-free, one drop 4 times a day in each eye (run-in period)
16057727|NCT02470416|Device|Small bowel video capsule endoscopy (VCE) GIVEN/COVIDIEN LTD|Cases and controls will have a standard VCE procedure at our institution.
16057728|NCT02470403|Drug|LIK066|LIK066 25 mg tablets
16057729|NCT02470403|Drug|Placebo|Matching placebo tablets
16057730|NCT02470390|Drug|Fentanyl|Lazanda (nasal spray), Subsys (sub-lingual) and intravenous fentanyl
16057731|NCT02470377|Device|Transcranial Magnetic Stimulation|A form of external neuromodulation using pulsatile magnetic fields on the surface of the head.
16057732|NCT02470338|Procedure|MBP plus arthroscopy (Group A)|
16057733|NCT02470338|Procedure|MBP alone (Group B)|
16057734|NCT02470325|Drug|Avidekel oil|Avidekel cannabis oil 6:1 CBD:THC
16057735|NCT02470325|Drug|Enriched Avidekel oil|Enriched Avidekel cannabis oil 20:1 CBD:THC
16057736|NCT02470312|Procedure|CRT implantation|It is a novel 3D electromagnetic navigation system (MediGuide™) that is capable of non-fluoroscopic navigation of sensor-enabled tools in the x-ray environment
16057737|NCT02470312|Device|MediGuide|
16057738|NCT02470312|Procedure|EP|
16057739|NCT02470299|Drug|Ketorolac|"Ketorolac tromethine 15 mg or 30 mg doses will be administered via intravenous (IV) push undiluted over 15 - 30 seconds
~Ketorolac will be dosed according to FDA approved recommendations. For planned three daily dose (IV) based on clinical scenario:
~Patients < 65 years of age: Daily dose of 30 mg for three doses.
~Patients ≥ 65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: Daily dose of 15 mg for three doses
~Blood and peritoneal fluid will be drawn prior to each dose (time 0, 24, 48, 72 hr) as well as at 6 hr after the first dose"
16057740|NCT02470299|Other|Placebo|"Equivalent volume of normal saline will be set in the syringe for each daily dose registered for the patient in a blinded fashion. The volume will be determined by the dose calculation as follows: For planned three daily dose (IV) based on clinical scenario:
~Patients < 65 years of age: Daily dose of 30 mg for three doses.
~Patients ≥ 65 years of age, renally impaired and/or less than 50 kg (110 lbs) of body weight: Daily dose of 15 mg for three doses.
~Blood and peritoneal fluid will be drawn prior to each dose (time 0, 24, 48, 72 hr) as well as at 6 hr after the first dose"
16057741|NCT02470286|Drug|SA001|
16057742|NCT02470286|Drug|Placebo|
16057780|NCT02469987|Drug|EU marketed Avastin(R)|Treatment C - single 1mg/kg dose of EU marketed Avastin® IV infusion over 90mins.
16058386|NCT02465814|Drug|Ulipristal|Ulipristal (12 weeks), treatment break, Placebo (12 weeks)
16057743|NCT02470247|Other|Remote Ischemic Preconditioning (RIPC)|"RIPC is accomplished by performing 4 cycles of alternating 5-minute inflation and 5-minute deflation of a standard upper-arm blood pressure cuff, to induce transient and repetitive arm ischemia and reperfusion.
~RIPC will be started just before the CTA, and the time between the last inflation cycle and the beginning of the CTA will be less than 45 minutes."
16057744|NCT02470247|Other|SHAM Remote Ischemic Preconditioning (SHAM RIPC)|"The SHAM Remote Ischemic Preconditioning (SHAM RIPC) will be carried out with the same number of cycles that the RIPC but cuff will be inflated to the diastolic pressure of the subject and the cuff will be deflated to10 mmHg in order to maintain a non- ischemic compression (blind patient protocol)."
16057745|NCT02470234|Drug|Methylphenidate HCl ER Capsules|Methylphenidate Hydrochloride Extended-Release Capsules administered once daily in the morning
16057746|NCT02470221|Other|Applying goal-directed fluid therapy by continuous hemodynamic monitoring system|Applying continuous hemodynamic monitoring system ( Vigileo/Flotrac) to monitor Stroke Volume Variation and Cardiac Output and further manage intra-operative fluid therapy.
16057747|NCT02470221|Other|Conventional fluid therapy|Applying conventional fluid therapy according to Peking Union Medical College Hospital standard.
16057748|NCT02470195|Behavioral|workshop|workshop for procedural simulation for education in difficult airway situation
16057749|NCT02470169|Drug|Merional|On the 3rd day of menstruation women will have a vaginal ultrasound and will receive daily intramuscular 150 IU of human menopausal gonadotropins (hMG, Merional ®, IBSA, Lugano, Switzerland) starting from the 3nd day of menstruation.
16057750|NCT02470169|Procedure|IUI|Semen will be processed and drawn into a shepherd catheter attached to a 1 mL syringe and injected into the uterus
16057751|NCT02470169|Drug|Choriomon|Administration of 10000 IU of human chorionic gonadotropin (hCG; Choriomon®, IBSA) when at least 2 follicles measuring 18 mm are observed during vaginal ultrasound and is associated with serum E2 of 500-3000 Pg/mL
16057752|NCT02470169|Device|shepherd catheter|
16057753|NCT02470169|Procedure|Ovulation detection|Women will be asked to test their morning urine specimen for luteinizing hormone daily starting 4 days before the expected day of ovulation. This will be done using a qualitative kit
16057754|NCT02470156|Behavioral|High Intensity Arm (Intervention)|The high intensity intervention involves monthly wellness coaching, personalized goal setting, and progress tracking in addition to monthly group activities and social support.
16057755|NCT02470156|Behavioral|Low Intensity Arm (Comparison)|The low intensity intervention involves wellness coaching, personalized goal setting, and progress tracking at baseline, 4 months, 8 months, and 12 months.
16057756|NCT02470143|Behavioral|Bike application arm|The intervention patients will use the cycling application on a smartphone, in combination with a wrist-worn heart rate monitor. During the study, the patients will use the cycling application for one month, in which they can make use of the cycling application each time they are cycling outdoor in their home environment.
16057757|NCT02470130|Behavioral|relaxation|5 min of conversational relaxation red by one of the instructor between simulation and debriefing
16057758|NCT02470117|Drug|Alginate-based reflux suppressant|
16057759|NCT02470117|Drug|magnesium-aluminium antacid gel|
16057760|NCT02470104|Dietary Supplement|Breastmilk|"A registered dietician will supervise milk provision.
~If a nursing mother enrolls on the study, maternal and not donor milk will be given in the maximum volume possible with Prolacta supplementation if clinically indicated and recommended by the registered dietician."
16057761|NCT02470091|Biological|Denosumab|Given SC
16057762|NCT02470091|Other|Laboratory Biomarker Analysis|Correlative studies
16057763|NCT02470091|Other|Pharmacological Study|Correlative studies
16057764|NCT02470078|Device|Phagenyx-Catheter, Phagenesis Limited, UK.|Pharyngeal electrical stimulation via an intraluminal catheter (Phagenesis Ltd.) once daily for 10 minutes on three consecutive days. The intensity of the electrical stimulation is determined following the calculation of suitable sensory threshold, tailored to the individual patients. After determining the optimal stimulation intensity, 10 minutes of stimulation are delivered.
16057765|NCT02470078|Device|Sham stimulation|The intraluminal catheter (Phagenesis Ltd.) for pharyngeal electrical stimulation is placed. In the sham group the optimisation procedure was imitated as closely as possible to mitigate any bias or effect of time spent interacting with the patient during PES, but no current was applied. After this procedure 10 min of sham stimulation were delivered.
16057766|NCT02470065|Drug|Afatinib|once daily afatinib at a dose of 40 mg for 8 weeks
16057767|NCT02470065|Procedure|Immediate surgery|anatomical resection and systematic lymph node dissection
16057768|NCT02470052|Device|OL-BF-001|Subjects assigned to this study will undergo a bronchoscopic procedure to have valves placed in the most diseased lobe of the lung to occlude all segments of the lobe. The subjects will also receive medical management.
16057769|NCT02470039|Drug|insulin 338 (GIPET I)|Oral administered once daily in combination with metformin with or without DPP-4 inhibitor
16057770|NCT02470039|Drug|insulin glargine|Injected s.c./subcutaneously (under the skin) once daily in combination with metformin with or without DPP-4 inhibitor
16057771|NCT02470039|Drug|placebo|Administered once daily
16057772|NCT02470026|Drug|yohimbine|single low dose treatment
16057773|NCT02470026|Drug|placebo|single control treatment
16057774|NCT02470013|Dietary Supplement|Balanced, energy dense, moderate protein sip feed|2x 125 ml bottles (equiv. 600 kcal) of Fortimel Compact daily for 3 months in addition to normal eating habits
16057775|NCT02470000|Device|Intravascular laser irradiation of blood (ILIB)|continuous-wave ILIB is performed using a 632.8nm (red light) laser beam from a He-Ne laser machine (Y-J ILIB-5, Bio Human Energy Cooperation, New Taipei City, Taiwan, R.O.C.).The participants sit on a sofa with their arms relax and supported on the table. A 24-gauge catheter is inserted to a superficial vein in upper extremity under sterile preparation, and an optic fiber channel is connected to the catheter for blood irradiation.
16057776|NCT02470000|Device|Transcutaneous electrical nerve stimulation|TENS over neck for 15 minutes.
16057777|NCT02470000|Other|Stretching exercise|stretching exercise to the involved muscle for 15 minutes.
16057778|NCT02469987|Drug|MYL-1402O|Treatment A - single 1mg/kg dose of MYL-14020 IV infusion over 90 mins.
16057779|NCT02469987|Drug|US marketed Avastin(R)|Treatment B - single 1mg/kg dose of US marketed Avastin® IV infusion over 90mins
16061193|NCT02446561|Drug|MRXXX|
16057781|NCT02469974|Drug|RUXOLITINIB / INC 424|Administered orally 5-20 mg twice daily x 16 weeks of therapy prior to attempted peripheral blood stem cells (PBSC) collection, during the collection and rest period and 3 months of therapy after high dose chemotherapy (HDC).
16057782|NCT02469974|Drug|Filgrastim|Peripheral blood stem cells (PBSC) will be mobilized with filgrastim 10 mcg/kg/day IV
16057783|NCT02469974|Drug|Busulfan|Conditioning for autologous Hematopoeitic Stem Cell Transplantation (HSCT) will consist of IV busulfan 2.0 mg/KBW once daily x 4 for days -5 to -2
16057784|NCT02469961|Drug|Dexmedetomidine|Participants will receive an interscalene block and will be sedated with Dexmedetomidine and compared to sedation with propofol
16057785|NCT02469961|Drug|Propofol|Participants will receive an interscalene block and be sedated with Propofol and compared to sedation with Dexmedetomidine
16057786|NCT02469961|Other|Interscalene block|Interscalene block is used for the main anesthetic for the case
16057787|NCT02469948|Drug|Botulinum toxin type A|To inject Botulinum toxin type A on the spasticity lower extremity for stroke patients by Ultrasonography direct-guidance, Electric stimulation and Surface anatomy landmark.
16057788|NCT02469935|Procedure|ultrasound|surgeon-performed ultrasound
16057789|NCT02469922|Device|Positron emission tomography|
16057790|NCT02469922|Radiation|radiochemotherapy|Every patients will be treated with radiochemotherapy as a standard of care
16057791|NCT02469909|Other|Overnight observation|patients in the immediate decannulation group would be admitted for an overnight in intensive care unit or the otolaryngology department. they would be monitored for any respiratory or airway complications.
16057792|NCT02469909|Other|Pre-discharge evaluation|After an overnight observation, patients in the immediate decannulation group would would undergo clinical and laboratory evaluation including vital signs and blood gases.
16057793|NCT02469909|Other|outpatient clinic follow ups|all patients would visit the otolaryngology outpatient clinic in 7, 30 and 90 days following decannulation for an evaluation of any respiratory complications following decannulation
16057794|NCT02469909|Procedure|immediate decannulation|the tracheostomy tube is removed at once
16057795|NCT02469909|Procedure|Gradual tracheostomy tube decrease|The tracheostomy tube will be reduced in 2 sizes compared with the initial inner diameter of the tube. The patients will remain with the reduced tube for 48 hours, and the tube will be removed if the patients would meet pre-decannulation evaluation
16057796|NCT02469896|Drug|Tocilizumab|IV Infusion
16057797|NCT02469896|Other|Placebo|IV Infusion
16057798|NCT02469883|Drug|Sinotecean|
16057799|NCT02469870|Behavioral|Autism Parent Trainer (APT)|Experimental condition
16057800|NCT02469870|Behavioral|Teaching Routines (Control)|Content comparison group.
16057801|NCT02469857|Drug|AB103 0.5 mg/kg|
16057802|NCT02469857|Other|NaCl 0.9%|
16057803|NCT02469831|Drug|Rocuronium|
16057804|NCT02469805|Drug|Merional|On the 3rd day of menstruation women will have a vaginal ultrasound and will receive daily intramuscular 150 IU of human menopausal gonadotropins (hMG, Merional ®, IBSA, Lugano, Switzerland) starting from the 3nd day of menstruation.
16057805|NCT02469805|Drug|Choriomon|Administration of 10000 IU of human chorionic gonadotropin (hCG; Choriomon®, IBSA) when at least 2 follicles measuring 18 mm are observed during vaginal ultrasound and is associated with serum E2 of 500-3000 Pg/mL.
16057806|NCT02469805|Procedure|IUI|Semen will be processed and drawn into a shepherd catheter attached to a 1 mL syringe and injected into the uterus
16057807|NCT02469805|Procedure|Ovulation detection|Women will be asked to test their morning urine specimen for luteinizing hormone daily starting 4 days before the expected day of ovulation. This will be done using a qualitative kit
16057808|NCT02469805|Device|Shepherd catheter|Processes semen will be drawn into a shepherd catheter attached to a 1 mL syringe and injected into the uterus
16057809|NCT02469792|Procedure|Liposuction|
16057810|NCT02469792|Device|ADRC isolation|ADRC isolation performed using Celution 800/CRS System (Cytori Therapeutics Inc) according to manufacturer's protocol
16057811|NCT02469792|Procedure|Arthroscopic surgery|
16057812|NCT02469792|Other|Intraarticular administration of autologous ADRC|
16057813|NCT02469779|Behavioral|Surveys|At baseline participants complete survey about their mental and physical health and their opinions concerning health information and the internet. The survey will take about 15-20 minutes to complete.
16057814|NCT02469779|Behavioral|ASPIRE Website|Participants view the ASPIRE website containing videos, activities, and health information facts about the effects of smoking, the benefits of meditation, and healthy living. This viewing will be videotaped
16057815|NCT02469779|Behavioral|ASPIRE Text-Based Website|Participants view the ASPIRE text-based website containing health information facts about smoking, the benefits of meditation, and healthy living.
16057816|NCT02469779|Behavioral|Follow Up Survey|Participants complete a follow-up survey about their opinions concerning health information and the internet immediately after they have completed their last session on the website.
16057817|NCT02469766|Procedure|SWL|Patients in this arm will undergo SWL
16057818|NCT02469766|Procedure|Semirigid URS|Patients in this arm will undergo semirigid URS
16057819|NCT02469766|Procedure|Flexible URS|Patients in this arm will undergo Flexible URS
16057820|NCT02469753|Drug|NSAIDs|continuous daily
16057821|NCT02469753|Drug|NSAIDs|on demand
16057822|NCT02469753|Drug|anti-TNF|
16057823|NCT02469740|Drug|Ticagrelor|Patients that are randomly selected to receive ticagrelor during the first phase of the study will receive the dose of 90 mg BD orally. This will be continued for 4 weeks before the endothelial function test will be performed. If the patients are assigned in the 2nd phase of the study, they will receive 90 mg BD orally for 5 weeks (4 weeks plus a 1 week washout period).
16057824|NCT02469740|Drug|Clopidogrel|Patients that are randomly selected to receive ticagrelor during the first phase of the study will receive the dose of 75 mg OD orally. This will be continued for 4 weeks before the endothelial function test will be performed. If the patients are assigned in the 2nd phase of the study, they will receive 75 mg OD orally for 5 weeks (4 weeks plus a 1 week washout period).
16057825|NCT02469727|Behavioral|Fitbit|Participants will use the FitBit device to track their physical activity
16057826|NCT02469727|Behavioral|Facebook group|Participants will receive and post messages and receive badges on the Facebook group
16061194|NCT02446561|Drug|MR1XXX|
16057827|NCT02469714|Behavioral|Peer Navigator Intervention|Peer navigators will be Hispanics/Latinos with a mental illness in recovery who will complete and meet certification for the peer navigator training program that will be evolved out of the mixed methods process. Investigators propose the peer navigators will enhance patient engagement in integrated care which will, in turn, improve physical and mental health and wellness of patients in this group
16057828|NCT02469701|Drug|nivolumab and ablation|
16057829|NCT02469688|Drug|ASP4070|intramuscular or intradermal
16057830|NCT02469688|Drug|Placebo|intramuscular or intradermal
16057831|NCT02469675|Device|Transcranial magnetic stimulation|One TMS pulse every 10 seconds for 20 minutes
16057832|NCT02469675|Device|Median nerve stimulation|One median nerve pulse every 10 seconds for 20 minutes
16057833|NCT02469675|Device|Cervical transcutaneous stimulation|One cervical pulse every 10 seconds for 20 minutes
16057834|NCT02469662|Device|Nexel Total Elbow|Nexel Total Elbow used in primary or revision total elbow arthroplasty
16057835|NCT02469623|Device|Dipole Density Mapping with AcQMap followed by ablation|
16057836|NCT02469610|Other|Intercostal block Bupivacaine based|Intercostal Bupivacaine block of 100ml over five intercostal spaces.
16057837|NCT02469597|Drug|Furosemide|1 mg/kg intravenous or oral (will give oral unless patient has peripheral IV access in place), maximum dose 10mg (1ml), x 1 dose
16057838|NCT02469597|Drug|Placebo|0.1ml/kg intravenous or oral (Normal Saline) (will give oral unless patient has peripheral IV access in place), maximum dose 1ml, x 1 dose
16057839|NCT02469584|Procedure|small stitch anterior colporrhaphy|A midline plication will be performed with continuous delayed absorbable sutures (3-0 polydioxanone) and the distance between the sutures will be 0.5 cm.
16057840|NCT02469571|Dietary Supplement|Winclove 607|multispecies probiotic
16057841|NCT02469571|Dietary Supplement|Placebo|Placebo
16057842|NCT02469558|Dietary Supplement|Winclove 851 and 110|prebiotic and probiotic mixture
16057843|NCT02469558|Dietary Supplement|Placebo|white powder without pro/probiotic
16057844|NCT02469545|Drug|Lactobacillus Plantarum 299v|Administering antidepressant drug (SSRI - selective serotonin reuptake inhibitor) and probiotic - 2x1 caps. per day of Lactobacillus Plantarum 299V (10mld colony forming units in 1 caps.) for 8 weeks.
16057845|NCT02469545|Drug|Crystalline cellulose powder|Administering antidepressant drug (SSRI - selective serotonin reuptake inhibitor) and placebo of probiotic - 2x1 placebo caps. filled with micro-crystalline cellulose powder for 8 weeks.
16057846|NCT02469545|Drug|Escitalopram|5-20mg daily
16057847|NCT02469545|Drug|Sertraline|50-100mg daily
16057848|NCT02469532|Device|Balloon Angioplasty|Device: Balloon Angioplasty Selection is driven by preference of the operator
16057849|NCT02469532|Device|Atherectomy System|Device: Orbital or Directional or Laser Atherectomy Systems Atherectomy selection is driven by preference of the operator
16057850|NCT02469519|Drug|Betamethasone - ACTIVE|antenatal corticosteroid (ACS) is to be given by injection 24 hours apart for two doses.
16057851|NCT02469519|Other|Normal Saline - PLACEBO|normal saline of the same quantity as with the experimental drug is to be given by injection 24 hours apart for two doses
16057852|NCT02469506|Device|Neuromuscular Electrical Stimulation (NMES)|The protocol will consist of a warm-up period (5 min), a stimulation period (30min), and a cooling-down period (5min). Stimulation will be provided by an Enraf Nonius TensMed S84 stimulation device.
16057853|NCT02469493|Device|acupuncture (Huatuo)|The needles used were Huatuo brand (Suzhou, China) sterile disposable stainless steel filiform; needles sized 0.25*25 mm. After disinfection, needles were inserted 0.5 to 0.8 inches into the skin and were manipulated manually to obtain Deqi. An electric stimulator (Huatuo SDZ-V, Suzhou, China) was connected to the needles and delivered a constant-current, 0.2-ms, density-wave, stimulus of 2 to 10-Hz frequency, level of intensity was as much as tolerable, but not painful to the subjects. The needles were left for 30 minutes and then removed.
16057854|NCT02469480|Drug|FerInject|FerInject: max. 2.000 mg of ferric carboxymaltose over max. 2 weeks (max. 1.000 mg per week).
16057855|NCT02469480|Drug|Ferro sanol|200 mg ferro sanol per day over 12 weeks
16057856|NCT02469467|Dietary Supplement|VS-505|VS-505 is orally administered with meal for 8 weeks
16057857|NCT02469454|Drug|early insertion|Postpartum women into whom the etonogestrel-releasing contraceptive implant (Implanon®, N.V. Organon, Oss, Netherlands) will be inserted in the first 48 h postpartum.
16057858|NCT02469454|Drug|conventional insertion|Postpartum women into whom the etonogestrel-releasing contraceptive implant (Implanon®, N.V. Organon, Oss, Netherlands) will be inserted in the first 6 week of delivery.
16057859|NCT02469428|Other|Clean air|Each subject will be exposed to clean air for 2 hours. Subjects will exercise on a bike. Each exercise session will consist of a 15 minute exercise interval at a level of up to 20 L/min/m2 BSA followed by a 15 minute rest period, repeated 4 times.
16057860|NCT02469428|Other|Ozone|Each subject will be exposed to 0.3 ppb ozone for 2 hours. Subjects will exercise on a bike. Each exercise session will consist of a 15 minute exercise interval at a level of up to 20 L/min/m2 BSA followed by a 15 minute rest period, repeated 4 times.
16057861|NCT02469415|Drug|Pacritinib|"Part 1: Pacritinib 200 mg taken by mouth twice daily.
~Part 2: Pacritinib dose decreased to 200 mg in the morning and 100 mg in the evening for the first cycle of combined therapy. If no toxicity is observed in first cycle of combined therapy, Pacritinib dose may be increased to 200 mg twice a day on subsequent cycles of combined therapy."
16057862|NCT02469415|Drug|5-azacitidine|Part 2 Starting Dose of 5-azacitidine: 75 mg/m2 by vein on Days 1 - 5 of Cycles 5 and beyond.
16057863|NCT02469415|Drug|Decitabine|Part 2 Starting Dose of Decitabine: 20 mg/m2 by vein on on Days 1 - 7 of Cycles 5 and beyond.
16057864|NCT02469402|Dietary Supplement|Standard infant formula|
16057865|NCT02469402|Dietary Supplement|Protein reduced alpha-lactalbumin formula, with higher levels of alpha-lactalbumin|
16057866|NCT02469389|Behavioral|Engaging in Community Roles and Experiences (ENCoRE)|Engaging in Community Roles and Experiences (ENCoRE) includes evidence-based psychosocial treatment strategies to target the affective-motivational deficits, negative expectancies, and behavioral skills deficits that are central to the maintenance of negative symptoms. Behavioral strategies include motivational enhancement, psychoeducation, cognitive therapy, and social skills training.
16057946|NCT02468869|Behavioral|"Communication skills training empathy skills"|
16061195|NCT02446561|Drug|MR2XXX|
16057867|NCT02469389|Behavioral|Health & Wellness (H&W)|"Health & Wellness (H&W) will focus on health and wellness issues and education on ways to better manage health-related concerns following a basic structure that includes: review of the previous session's material, new educational content, and discussion/application.
~Topics will include: 1) Overview, 2) Physical Activity (3 sessions), 3) Nutrition/Healthy Eating (3 sessions), 4) Managing Fatigue/Sleep (3 sessions), 5) Relaxation (3 sessions), 6) Tobacco cessation (3 sessions), 7) Substance Use (3 sessions), 8) Medication/Side Effects (3 sessions), 9) Review (1 session), and Closing (1session)."
16057868|NCT02469376|Drug|[18F]-GP1|Radiopharmaceutical Product (Tracer) to visualize with Positron Emission Tomography a thrombus in humans.
16057869|NCT02469363|Device|Macintosh laryngoscope|Hemodynamic parameters after endotracheal intubation with Classic laryngoscope (Macintosh)
16057870|NCT02469363|Device|Mc-Coy laryngoscope|Hemodynamic parameters after endotracheal intubation with Mc-Coy laryngoscope
16057871|NCT02469363|Device|C-Mac videolaryngoscope|Hemodynamic parameters after endotracheal intubation with C-Mac videolaryngoscope
16057872|NCT02469363|Device|McGrath videolaryngoscope|Hemodynamic parameters after endotracheal intubation with McGrath videolaryngoscope
16057873|NCT02469350|Other|Serious game|Rehabilitation with serious game
16057874|NCT02469337|Drug|Dichloroacetate|Dichloroacetate, an analog of acetic acid has been shown to increase the activation of PDC by inhibiting PDK4 in humans. This drug is expected to shift the metabolism of pyruvate from glycolysis and towards oxidative pathway in the mitochondria
16057875|NCT02469337|Dietary Supplement|Carbohydrate drinks|preoperative carbohydrate drinks
16057876|NCT02469337|Behavioral|Moderate intensity exercise|30 min exercise using a semi-recumbent exercise bike, at about 70% of their age estimated heart rate
16057877|NCT02469324|Behavioral|Cognitive Behavioral Therapy|The course will be two weeks long, including the didactic portion of each course and the follow-up exercises (meditations for the CMT condition and exercises for the CBT condition) practiced daily for a total of two weeks. The course will contain two distinct parts. Part (a) will consist of a 45-minute didactic lesson that covers the basics of each approach. The course will provide a narrative rationale and the motivation for participants to complete the exercise portion of the course. Part (b) will be presented following completion of the didactic portion of the course. Participants will receive an automatically generated email following completion of the didactic that will include information on the follow-up exercises, suggestions for how to continue practicing, and a link to the the didactic portion of the course in case they want to review it again. Two weeks after enrollment and the completion of Part (b), participants will be invited to complete the post baseline measures.
16057878|NCT02469324|Behavioral|Compassionate Mind Training|see above
16057879|NCT02469311|Other|chlorhexidine impregnated cloths|Pre-operative use of Chlorhexidine cloths night before and morning of surgery
16057880|NCT02469311|Other|Standard of care bathing with antibacterial soap and water|Patients had standard pre-operative bathing with antibacterial soap and water the night before surgery.
16057881|NCT02469298|Drug|GSK1325756 (Danirixin)|It will be supplied as capsule shaped white film coated tablet containing 75 mg GSK1325756 for oral use
16057882|NCT02469298|Drug|Placebo To Match GSK1325756|It will be supplied as capsule shaped white film coated placebo tablet for oral use
16057883|NCT02469298|Drug|Oseltamivir Phosphate|It will be supplied as size 0 Swedish Orange capsule containing 75 mg Oseltamivir phosphate and overfill of pre-gelatinized starch for oral use
16057884|NCT02469298|Drug|Placebo To Match Oseltamivir Phosphate|It will be supplied as size 0 Swedish Orange capsule containing pre-gelatinized starch and magnesium stearate for oral use
16057885|NCT02469285|Dietary Supplement|Modified pork|Pork with modified fatty acid composition
16057886|NCT02469285|Dietary Supplement|Pork|Pork with normal fat composition
16057887|NCT02469285|Dietary Supplement|Pork and berries|Pork with normal fat composition and Finnish berries
16057888|NCT02469272|Drug|Fecal Microbiota Transplantation|Administration of frozen fecal materials into gastrointestinal tract
16057889|NCT02469259|Drug|Oxytocin|
16057890|NCT02469259|Other|Placebo|
16057891|NCT02469246|Drug|F/TAF|200/10 mg FDC tablet (with boosted 3rd ARV agents) or 200/25 mg FDC tablet (with unboosted 3rd ARV agents) administered orally once daily
16057892|NCT02469246|Drug|ABC/3TC|600/300 mg FDC tablets administered orally once daily
16057893|NCT02469246|Drug|ABC/3TC Placebo|Tablets administered orally once daily
16057894|NCT02469246|Drug|F/TAF Placebo|Tablets administered orally once daily
16057895|NCT02469246|Drug|3rd ARV agent|An allowed 3rd ARV agent of the participant's pre-existing regimen may include one of the following boosted ARV agents: ritonavir boosted lopinavir (LPV/r), atazanavir (ATV) + ritonavir (RTV), ATV + cobicistat (COBI) or ATV/COBI FDC, darunavir (DRV) + RTV, DRV+COBI or DRV/COBI FDC; or, one of the following unboosted ARV agents: efavirenz (EFV), rilpivirine (RPV), raltegravir (RAL), dolutegravir (DTG), maraviroc (MVC), or nevirapine (NVP).
16057896|NCT02469233|Behavioral|Transdiagnostic Intervention for Sleep and Circadian Dysfunction|The intervention is a modular treatment composed of core modules that are given to all participants and modules that are delivered based on the need/s of the participants. The interventions are all cognitive behavioral.
16057897|NCT02469220|Dietary Supplement|Low FODMAP|Blinded food supplements containing only items with a low content of FODMAPs
16057898|NCT02469220|Dietary Supplement|Standardized FODMAP|Blinded food supplements containing FODMAPs
16057899|NCT02469207|Other|Removal of tissue post-mortem|
16057900|NCT02469194|Other|Blood Draw|5-10 cc of whole blood will be obtained using standard, sterile venipuncture techniques
16057901|NCT02469168|Device|Recell|ReCell Treatment over wound pretreated with INTEGRA™ MBWM Wound Matrix
16057902|NCT02469168|Procedure|Control|Standard meshed split thickness skin graft over wound pretreated with INTEGRA™ MBWM Wound Matrix
16057903|NCT02469155|Drug|ITI-007|
16057904|NCT02469155|Drug|Risperidone|
16057905|NCT02469155|Drug|Placebo|
16057906|NCT02469142|Procedure|ADM tension-free hernia reparation|Use ADM as opposed to nothing to repair incarcerated inguinal hernia
16057947|NCT02468869|Behavioral|"Communication skills training information structuring skills"|
16058018|NCT02468323|Drug|Ondansetron|Patients will receive slow intravenous injection of ondansetron 4 mg after cord clamping
16061196|NCT02446561|Drug|MR3XXX|
16057907|NCT02469129|Drug|[18F]FluorThanatrace|"For the Dosimetry Studies, 10 mCi of [18F]FTT will be injected intravenously, and participants will be placed in the following groups to be imaged with PET at the specified time points: 0 minute group--image at 0 and 120 min. after tracer injection; 30 minute group--image at 30 and 150 min. after tracer injection; 60 minute group--image at 60 and 180 min. after tracer injection; and 90 minute group--image at 90 and 210 min. after tracer injection.
~For the Kinetic Studies, 10 mCi of [18F]FTT will be injected intravenously, and a 60-minute dynamic PET scan will be obtained starting at the time of injection."
16057908|NCT02469116|Drug|Docetaxel|
16057909|NCT02469116|Drug|Carboplatin|
16057910|NCT02469116|Drug|Pegylated G-CSF|
16057911|NCT02469103|Device|C2|C2 and colonoscopy will be performed one after another on the same day
16057912|NCT02469103|Procedure|colonoscopy|
16057913|NCT02469090|Drug|APL-130277|"Use to treat up to 5 OFF episodes per day"
16057914|NCT02469090|Drug|Placebo|placebo
16057915|NCT02469077|Behavioral|6 week aerobic exercise intervention|"Participants randomly assigned to the 6 week aerobic exercise intervention will complete an 18 session aerobic exercise manipulation supervised by an American College of Sports Medicine-certified personal trainer (3 exercise sessions per week for 6 weeks).
~Each exercise session will consist of a 5 minute warm-up, 30 minutes of aerobic exercise, followed by a 5 minute cool-down period. Aerobic exercise will consist of treadmill walking/running, stepping, elliptical, or cycling exercise as preferred by the participant. Duration of exercise will be standardized at 30 minutes with a target exercise intensity between 70-85% Heart Rate Reserve (RPE = 15, hard). Because of the focus on de-conditioned individuals with Chronic Low Back Pain, the duration and intensity of exercise will be progressively increased up to target during the first two weeks to avoid symptom exacerbation and minimize study drop-out."
16057916|NCT02469077|Drug|Placebo|In randomized order (crossover) across 3 laboratory sessions each approximately 5 days apart, participants will undergo laboratory evoked thermal pain response testing with: 1) 4 doses of saline placebo (20ml each), 2) an 8mg dose of naloxone (in 20ml saline vehicle), followed by saline, 4mg naloxone, and saline, or 3) morphine sulfate (0.03 mg/kg in 20ml saline vehicle initially, followed by 3 incremental doses of 0.02mg/kg each).
16057917|NCT02469077|Drug|Morphine|In randomized order (crossover) across 3 laboratory sessions each approximately 5 days apart, participants will undergo laboratory evoked thermal pain response testing with: 1) 4 doses of saline placebo (20ml each), 2) an 8mg dose of naloxone (in 20ml saline vehicle), followed by saline, 4mg naloxone, and saline, or 3) morphine sulfate (0.03 mg/kg in 20ml saline vehicle initially, followed by 3 incremental doses of 0.02mg/kg each).
16057918|NCT02469077|Drug|naloxone|In randomized order (crossover) across 3 laboratory sessions each approximately 5 days apart, participants will undergo laboratory evoked thermal pain response testing with: 1) 4 doses of saline placebo (20ml each), 2) an 8mg dose of naloxone (in 20ml saline vehicle), followed by saline, 4mg naloxone, and saline, or 3) morphine sulfate (0.03 mg/kg in 20ml saline vehicle initially, followed by 3 incremental doses of 0.02mg/kg each).
16057919|NCT02469064|Other|Respiratory muscle training|Respiratory muscle training is done twice every day, with 3 series of 10 repetitions each, with a resting pause of two minutes between series (during resting time, patient is connected to mechanical ventilation again). We adjust initial load for respiratory muscle training as 50% of MIP. At the end of every training session, we assess dyspnea (perceived effort) using Modified Borg Scale (23). Four physical therapists are in charge of Respiratory muscle training, these therapists work at ICU and have experience with critically ill patients.
16057920|NCT02469064|Other|Cardiopulmonary Physical Therapy|Control group receives Cardiopulmonary Physical Therapy every 6 hours, physical therapy and mechanical ventilation management
16057921|NCT02469051|Device|Breathhold SPECT-MPI|Respiratory triggered SPECT myocardial perfusion imaging
16057922|NCT02469051|Device|Standard freebreathing SPECT-MPI|Clinically indicated, standard non-respiratory triggered SPECT myocardial perfusion imaging
16057923|NCT02469051|Device|Coronary CT angiography|Clinically indicated coronary CT angiography serving as standard of reference
16057924|NCT02469038|Device|AccuCath catheter|Ultrasound-guided insertion of an AccuCath catheter during a standard of care procedure.
16057925|NCT02469038|Device|Control|Ultrasound-guided insertion of a conventional IV catheter during a standard of care procedure.
16057926|NCT02469025|Other|Manual caudal traction mobilization in resting position|
16057927|NCT02469025|Other|Manual caudal traction mobilization in end range position|
16057928|NCT02469025|Other|Selftreatment|Each subject is advice to do some exercises at home
16057929|NCT02469012|Drug|Combination #1|Sofosbuvir + Ribavirin
16057930|NCT02469012|Drug|Combination #2|Sofosbuvir + Daclatasvir
16057931|NCT02469012|Drug|Combination #3|Sofosbuvir + Daclatasvir + Ribavirin
16057932|NCT02469012|Drug|Combination #4|Sofosbuvir + Ledipasvir
16057933|NCT02469012|Drug|Combination #5|Sofosbuvir + Ledipasvir + Ribavirin
16057934|NCT02468999|Drug|human insulin|
16057935|NCT02468973|Behavioral|Life style counseling|Life style counseling for chronic patients by medical students
16057936|NCT02468960|Device|Predilatation with OPN NC balloon catheter.|Target lesion will be prepared by predilatation with OPN NC balloon catheter.
16057937|NCT02468960|Device|Predilatation with standard compliant balloon.|Target lesion will be prepared by predilatation with standard balloon catheter (compliant).
16057938|NCT02468960|Device|Absorb BVS implantation.|After lesion preparation implantation of BVS Absorb scaffold will be performed.
16057939|NCT02468960|Procedure|Treated segment visualization by OCT.|Finally treated segment will be visualized by Intravascular Optical Coherence Tomography (OCT).
16057940|NCT02468960|Other|Clinical FU at 12 months.|All patients will be clinically followed for 12 months.
16057941|NCT02468934|Device|SPRINT Peripheral Nerve Stimulation (PNS) System|"The SPRINT System is an Investigational Device which delivers mild electrical stimulation to nerves in the leg that underwent lead placement. The SPRINT System includes a small wire (called a Lead) that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator)."
16057942|NCT02468921|Procedure|Thyroidectomy|Regular thyroidectomy or hemithyroidectomy through Kocher's skin incision
16057943|NCT02468908|Drug|Molgramostim|
16057944|NCT02468908|Drug|Placebo|
16057945|NCT02468882|Dietary Supplement|Watercress|100g of watercress daily during radiation therapy
16057948|NCT02468856|Drug|armodafinil|Armodafinil 250 mg tablet single dose administration. Outcome measures: Driving simulator performance, Electroencephalogram activity, Area under the plasma concentration versus time curve (AUC), Motor Praxis Task, the Visual Object Learning Test, the Fractal-2-Back, the Abstract Matching, the Line Orientation Test, the Digit-Symbol Substitution Task, the Balloon Analog Risk Test, and the Psychomotor Vigilance Test
16057949|NCT02468856|Drug|Placebo (for armodafinil)|Placebo tablet single dose administration. Outcome measures: Driving simulator performance, Electroencephalogram activity, Motor Praxis Task, the Visual Object Learning Test, the Fractal-2-Back, the Abstract Matching, the Line Orientation Test, the Digit-Symbol Substitution Task, the Balloon Analog Risk Test, and the Psychomotor Vigilance Test
16057950|NCT02468843|Device|Biphasic DBS stimulation|"The following protocol will be followed for each subject. In between, baseline and novel stimulation settings there will be a 30-minute washout period with DBS in the off state.
~Current best/optimized DBS setting (considered baseline)
~DBS off for 30 minutes
~Biphasic pulse stimulation mode (immediate assessment)
~Biphasic pulse stimulation mode (assessment at 1h)
~Biphasic pulse stimulation mode (assessment at 2h)"
16057951|NCT02468843|Other|Unified Dystonia Rating Scale|Neurologist use the UDRS to determine the severity and duration of dystonia on 14 body areas.
16057952|NCT02468843|Other|Burke-Fahn- Marsden scale|Neurologist use the BFMDRS to rate the severity of dystonia in 9 regions of the body.
16057953|NCT02468830|Drug|mirabegron|Switch treatment from antimuscarinic to study medication. A dose up-titration will be possible if well tolerated and sub-optimal efficacy.
16057954|NCT02468817|Procedure|Treadmill Exercise|2 (two) 1-hour of vigorous exercise bouts under different thermal conditions
16057955|NCT02468817|Procedure|Magnitude of Ca loss during Exercise at 26 degrees Celcius|Blood samples at 15-min intervals starting 15 min before exercise and ending 60 min after exercise
16057956|NCT02468804|Device|rTMS|TMS: Repetitive TMS will be administered using a 70-mm diameter air-cooled figure-of-8 coil and SuperRapid2 Stimulator (Magstim, Jali Medical US distributors, Woburn, MA). Repetitive pulses will be delivered to the right and left pre-frontal cortex (Brodman area 46) using a frameless stereotactic navigation system and the subject's MRI in Brainsight software. Stimuli will be delivered at 20 Hz at 90% of the subjects resting motor threshold (rMT) for 25 trains of 30 pulses per train, inter-train interval of 30 seconds for a total of 750 pulses per hemisphere. The same TMS parameters as active stimulation but with the coil held at 90° to the scalp to induce similar somatic sensations and noise as in the active group with minimal direct brain effects.
16057957|NCT02468804|Device|Sham TMS|Sham TMS will be administered with a Magstim sham coil with electrodes attached to mimic the sounds and sensation of real TMS. The site and frequency of stimulation will be identical to the real TMS described above.
16057958|NCT02468791|Drug|Rituximab|
16057959|NCT02468778|Device|HeartMate PHP|The HeartMate PHP System is a temporary (<6 hours) ventricular assist device indicated for use during high-risk percutaneous coronary interventions (PCI) performed electively or urgently in hemodynamically stable patients with severe coronary artery disease, when a heart team, including a cardiac surgeon, has determined high-risk PCI is an acceptable therapeutic option. Use of the HeartMate PHP Systems in these patients may prevent hemodynamic instability, which can result from repeat episodes of reversible myocardial ischemia that occur during planned temporary coronary occlusions and may reduce peri-and post-procedural adverse events.
16057960|NCT02468778|Device|Any Abiomed Impella® device approved for use in high-risk PCI|Any Abiomed Impella® device approved for use in high-risk PCI.
16057961|NCT02468765|Other|Neuropsychological and emotional evaluation with monitoring|Recognition tasks of emotional facial expressions with electroencephalogram, electrodermal activity measure and heart rate measure, questionnaires and neuropsychological tests
16057962|NCT02468752|Drug|Oxygen|
16057963|NCT02468752|Other|Air|
16057964|NCT02468739|Drug|Ganglioside-monosialic acid|Ganglioside-monosialic sodium is added into to 250 ml of 0.9% sodium chloride injection, which is given once a day via intravenous drip infusion for 3 days. The first dose is given at 1 day before the start of the chemotherapy.(day -1, day 1 and day2). The dosages of GM1 are 80mg per day.
16057965|NCT02468739|Drug|placebo|Placebo is added into to 250 ml of 0.9% sodium chloride injection, which is given once a day via intravenous drip infusion for 3 days. The first dose is given at 1 day before the start of the chemotherapy.(day -1, day 1 and day2).
16057966|NCT02468726|Device|NER1008 enema|NER1008 enema administered to cleanse the bowel bewteen 1 and 3 hours prior to flexible sigmoidoscopy
16057967|NCT02468726|Drug|Fleet|Fleet enema administered to cleanse the bowel bewteen 1 and 3 hours prior to flexible sigmoidoscopy
16057968|NCT02468713|Drug|Combiflex® lipid peri|total parenteral nutrition solutions containing glucose, amino acids, electrolyte, soybean oil
16057969|NCT02468713|Drug|Winuf® peri|total parenteral nutrition solution containing glucose, amino acids, electrolyte, soybean oil, medium chain triglyceride, olive oil and fish oil
16057970|NCT02468700|Drug|Dexamethasone|
16057971|NCT02468700|Other|Placebo Vehicle|
16057972|NCT02468687|Drug|N-methyl-pyrrolidone|NMP will be taken each morning as a single daily dose of oral suspension at a concentration of 50mg/ml on an empty stomach at least 30 minutes prior to food.
16057973|NCT02468674|Drug|bimagrumab|"bimagrumab low dose bimagrumab moderate dose bimagrumab high dose
~Patients enrolled prior to the protocol amendment 1 (Population I ), who received bimagrumab in the core study, entered the extension study at Week 25 and were randomly assigned to two subgroups within each of three treatment arms to either receive bimagrumab at the same dose level or placebo. Study medication was administered as an intravenous infusion starting at Week 25 after treatment was initiated in the core study until week 45."
16057974|NCT02468674|Drug|Placebo|"Placebo
~Patients enrolled prior to the protocol amendment 1 (Population I), who received placebo in core study, entered the extension study at Week 25 and received placebo as an intravenous infusion starting at Week 25 after treatment was initiated in the core study until week 45."
16057975|NCT02468661|Drug|INC280 single agent|
16057976|NCT02468661|Drug|erlotinib|
16057977|NCT02468648|Drug|Sofosbuvir|An NS5B polymerase inhibitor that is already approved for use in combination with interferon and ribavirin for the treatment of HCV genotype 1 infection
16057978|NCT02468648|Drug|GS-5816|An NS5A replication complex inhibitor with potent activity against most strains of hepatitis C virus.
16058145|NCT02467504|Drug|Loxoprofen|Loxoprofen (oral administration)
16057979|NCT02468635|Other|upper limb exercises|HEATING PHASE: diagonals for upper and lower limbs (5-10 minutes). AEROBIC PHASE: aerobic exercise on a treadmill or bicycle between 5 - 30 minutes and rest 1-2 minutes according to the Borg scale and patient tolerance (Borg scores for dyspnea 4-5); RESISTANCE STAGE: upper limb exercises with weight training equipment or dumbbells (the patient's adaptation) with 50% of maximum load reached the maximum repetition test. Series 2 minutes and rest interval between sets 1-2 minutes. RESPIRATORY TRAINING : Strengthening of the respiratory muscles 5-15 minutes with Threshold with load of 50% of the affected MIP (measure maximal inspiratory pressure) evaluation. RELAXATION: Stretching and muscle massage therapy group involved in the 5-10 minute workout.
16057980|NCT02468635|Other|without training for upper limb|HEATING PHASE: diagonals for upper and lower limbs (5-10 minutes). AEROBIC PHASE: aerobic exercise on a treadmill or bicycle between 5 - 30 minutes and rest 1-2 minutes according to the Borg scale and patient tolerance (Borg scores for dyspnea 4-5); RESPIRATORY TRAINING: Strengthening respiratory muscles 5-15 minutes with Threshold with load of 50% of MIP hit in the evaluation. RELAXATION: Stretching and muscle massage therapy group involved in the 5-10 minute workout.
16057981|NCT02468622|Other|Blood samples|There is no intervention, but we will take blood samples during a spontaneous migraine attack
16057982|NCT02468609|Radiation|Ultralow-Dose-CT|Patients undergoing thoracic normal dose-CT with undergo an additional Ultralow-Dose-CT
16057983|NCT02468596|Other|QTRAC assessment|Computerized analysis of the muscular response of musculus abductor pollicis brevis, to series of electrical stimulations of the median nerve
16057984|NCT02468596|Other|Clinical assessment of peripheral nerve function|Clinometric assessment using RT-MRC, Martin vigirometer, RT-mISS, T25W, 9 hole peg test, and ataxia scale
16057985|NCT02468583|Drug|FX006 32 mg|Experimental
16057986|NCT02468583|Drug|TCA IR 40 mg|Comparator
16057987|NCT02468570|Other|Administration of CANTAB and Subject Global Assessment|At designated visits, subject will perform the CANTAB tasks and complete the Subject Global Assessment Questionnaire
16057988|NCT02468557|Drug|Idelalisib|Tablets administered orally twice daily
16057989|NCT02468557|Drug|Nab-paclitaxel|125 mg/m^2 administered intravenously on Days 1, 8 and 15 of each 28 day cycle
16057990|NCT02468557|Drug|mFOLFOX6|mFOLFOX6 will be administered intravenously on Days 1 and 15 of each 28 day cycle. This regimen consists of levoleucovorin 200 milligram/meter per square (mg/m^2) or racemic leucovorin 400 mg/m^2, oxaliplatin 85 mg/m^2, bolus 5-fluorouracil 400 mg/m^2, and a 46 hour infusion of 5-fluorouracil 2, 400 mg/m^2.
16057991|NCT02468544|Other|Text messaging|Text messaging mHealth intervention to improve HIV Primary Care Engagement among clients of methadone maintenance treatment programs who are living with HIV.
16057992|NCT02468531|Other|oxygen|50% oxygen inhalation
16057993|NCT02468531|Drug|Xenon|50% Xenon inhalation
16057994|NCT02468518|Drug|Vitamin E capsule|Capsules will be distributed to each participant free of cost
16057995|NCT02468505|Behavioral|STEPS|time-limited behavioral counseling, online materials, training
16057996|NCT02468492|Biological|Platelet Rich Plasma|Platelet rich plasma injection into knee versus placebo (saline) injection.
16057997|NCT02468492|Other|Normal Saline|Platelet rich plasma injection into knee versus placebo (saline) injection.
16057998|NCT02468479|Other|No relevant intervention.|No relevant intervention.
16057999|NCT02468466|Behavioral|Multi-level suicide prevention programs|The intervention included both screening and educational components. The screening component invited residents aged 36-64 years to participate in a two-step screening program. In the initial screening, a self-report questionnaire were mailed to all of those residents in the priority districts with a past high suicide rate. The second stage was conducted for the participants who screened positive though a semi-structural interview. Based on the results, participants who were diagnosed with a major depressive episode were provided with a referral to a psychiatry and support for treatment adherence. Written feedback on the screening results was mailed to all respondents. The educational component was implemented through workshops open to the general public (3 times every year) and local public newsletters (twice every year) designed to improve access and adherence to treatment and to reduce stigma associated with suicide and depression.
16058000|NCT02468466|Behavioral|Suicide prevention program as usual|Usual mental health program (not including depression screening among middle-aged)
16058001|NCT02468453|Device|velos|VELOS combines 595nm pulsed dye laser energy with bipolar RF energy. The study device can deliver 0.45 to 40 ms laser pulses at a maximum of 25 J/cm2
16058002|NCT02468440|Other|ESPAIR|ESPAIR is an educational therapy's program with 6 group session,and if patients ask for it, individual session are possible
16058003|NCT02468427|Other|hands-on teaching|Training session of 30 minutes duration with every proband performing a vacuum extraction on a pelvic training model.
16058004|NCT02468427|Other|Frontal teaching|Training session of 30 minutes duration consisting of a video which demonstrates how to perform a vacuum extraction on a pelvic training model.
16058005|NCT02468414|Biological|MDGN201 TARGTEPO|MDGN201 TARGTEPO secreting EPO (18-25 IU/Kg/day)
16058006|NCT02468414|Biological|MDGN201 TARGTEPO|MDGN201 TARGTEPO secreting EPO (35-45 IU/Kg/day)
16058007|NCT02468401|Procedure|Percutaneous coronary intervention|Patients planned for coronary angiography or percutaneous coronary intervention will be managed using a protocol that allows us to use minimal volumes of contrast dye
16058008|NCT02468388|Other|maltitol|maltitol chewing gum: 66% SweetPearlTM Maltitol +30.91% gum base+1.93% Lycasin R 85/55+0.39% glycerin; two pellets for 10 min five times each day
16058009|NCT02468388|Other|xylitol|xylitol chewing gum: 67.73% xylitol +30.02% gum base+1.13% Lycasin R 85/55+0.38% glycerin; two pellets for 10 min five times each day
16058010|NCT02468388|Other|gum base|gum base: 99% gum base; two pellets for 10 min five times each day
16058011|NCT02468375|Drug|mirabegron 50mg|434 OAB patient intake mirabegron 50mg/day for 12 weeks.
16058012|NCT02468362|Procedure|laparoscopic intersphincteric resection|laparoscopic intersphincteric resection for low rectal cancer
16058013|NCT02468362|Procedure|open intersphincteric resection|
16058014|NCT02468349|Other|Telemedicine|Participants enrolled will be randomised 1:1 to either telemedicine arm or standard care arm.
16058015|NCT02468336|Device|AngioDefender|
16058016|NCT02468336|Device|Ultrasound|
16058017|NCT02468323|Drug|Placebo|Patients will receive regular spinal anesthesia
16058019|NCT02468323|Drug|Palonosetron|Patients will receive slow intravenous infection of palonosetron 75 mcg after cord clamping
16058020|NCT02468310|Other|Maternal and neonatal emergency protocols|Protocols for management of Maternal and Neonatal emergencies based on the Safe Motherhood protocol adopted by the Ghana Health Service to improve maternal and neonatal health
16058021|NCT02468297|Device|Electronic Acupunture Shoes|"Experiment group receives a one-hour treatment given by Electronic Acupuncture Shoes three times a week. 6 weeks of treatment was given.
~Control group received the six-week treatment as well, yet the subjects received pseudo electrotherapy."
16058022|NCT02468297|Drug|Ibuprofen|Experiment group took placebo only in the first week. Control group took ibuprofen(400mg, TID) only in the first week. No more placebo or medicine was prescribed to either two groups since the second week.
16058023|NCT02468284|Drug|degarelix|
16058024|NCT02468258|Procedure|endometrial flushing|Oocytes were retrieved 34-36 h after hCG administration and aspirated FF was collected and centrifuged at 600 rpm for 10 min and 5-ml sample of supernatant was obtained for ELISA estimation of tumor necrosis factor-α (TNF-α), granulocyte colony-stimulating factor (G-CSF), leptin and anti-Mullerian Hormone (AMH) levels in both groups. The remaining amount was used for endometrial flushing
16058025|NCT02468245|Behavioral|weekly telephone follow up|For the study group, at the initial education visit, a time for each phone call that is convenient for the patient will be scheduled. At each phone call, the OCN will get a pill count and discuss reasons for missed doses if applicable; grade any AE's experienced and interventions for those side effects; and answer any questions or concerns that they patient may be having. Patients will then return for the standard 4 week clinic visit.
16058026|NCT02468245|Behavioral|usual care|The control group will receive the standard chemotherapy education and will return for the standard 4 week follow up clinic visit.
16058027|NCT02468232|Drug|LCZ696|LCZ696 50 mg, 100 mg, 200 mg film-coated tablets
16058028|NCT02468232|Drug|Enalapril|Enalapril 2.5 mg, 5 mg, 10 mg film-coated tablets
16058029|NCT02468232|Drug|Placebo to LCZ696|Placebo to match LCZ696 50 mg, 100 mg and 200 mg film-coated tablets
16058030|NCT02468232|Drug|Placebo to Enalapril|Placebo to match enalapril 2.5 mg, 5 mg and 10 mg film-coated tablets
16058031|NCT02468219|Behavioral|cardiovascular rehabilitation program|"Phase I: 2-weeks of respiratory muscle training and neuromuscular electrical stimulation (daily at hospital).
~Phase II: 6-weeks of respiratory muscle training and neuromuscular electrical stimulation (daily at home).
~Phase III: 8-weeks of supervised, structured, combined aerobic and resistance training."
16058032|NCT02468206|Procedure|Balloon-occluded retrograde transvenous obliteration|Balloon-occluded retrograde transvenous obliteration
16058033|NCT02468206|Procedure|Endoscopic cyanoacrylate injection|Endoscopic cyanoacrylate injection
16058034|NCT02468206|Drug|N-butyl-2-cyanoacrylate|
16058035|NCT02468206|Drug|Lauromacrogol|
16058036|NCT02468193|Drug|Osilodrostat|Osirodrostat 1mg, 5mg & 10mg in the form of film-coated tablets was used for oral administration.
16058037|NCT02468180|Procedure|Balloon-occluded retrograde transvenous obliteration|Balloon-occluded retrograde transvenous obliteration
16058038|NCT02468180|Procedure|Endoscopic cyanoacrylate injection|Endoscopic cyanoacrylate injection
16058039|NCT02468180|Drug|N-butyl-2-cyanoacrylate|
16058040|NCT02468180|Drug|Lauromacrogol|
16058041|NCT02468167|Procedure|Balloon-occluded retrograde transvenous obliteration|Balloon-occluded retrograde transvenous obliteration
16058042|NCT02468167|Procedure|Endoscopic cyanoacrylate injection|Endoscopic cyanoacrylate injection
16058043|NCT02468167|Drug|N-butyl-2-cyanoacrylate|
16058044|NCT02468167|Drug|Lauromacrogol|
16058045|NCT02468154|Device|custom made splint|Splints have been made by wrapping synthetic bandages around a leg-foot manufactured splint padded at the heel to off-load the heel. When the desired shape has been obtained, the splint is opened and the manufactured device is removed, thus obtaining a device that is used under the casts of lower limbs.
16058046|NCT02468154|Other|standard off-load plaster cast|To avoid pressure at the heel placing and maintaining the limb with the cast on cushions or folded sheets so that the heel is not resting on the bed plane
16058047|NCT02468141|Drug|SJDBT|Sipjeondaebo-tang
16058048|NCT02468141|Drug|Placebo|Placebo
16058049|NCT02468128|Drug|Sebacoyl Dinalbuphine Ester|Intramuscular injection 2mL/vial (75mg/mL)
16058050|NCT02468128|Drug|Placebo|Sebacoyl Dinalbuphine Ester injection placebo, 2mL/vial
16058051|NCT02468115|Drug|VIS410|Single fixed IV dose of VIS410
16058052|NCT02468115|Drug|Placebo|Single IV dose of placebo
16058053|NCT02468102|Drug|Rivaroxaban (Xarelto, BAY59-7939)|"Treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE), and prevention of recurrent DVT and PE (15 mg rivaroxaban twice daily [bid] for 3 weeks, then 15 mg or 20 mg once daily [od], tablets).
~Prevention of stroke and systemic embolism with non-valvular atrial fibrillation (stroke prevention in atrial fibrillation [SPAF]) with one or more risk factors, prior stroke or transient ischaemic attack (20 mg rivaroxaban [od], tablets).
~Prevention of venous thromboembolism (VTE) in patients undergoing elective hip or knee replacement surgery (recommended dose: 10 mg rivaroxaban [od] tablets for 35 days following hip replacement surgery and 14 days following knee replacement surgery).
~Co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, for the prevention of atherothrombotic events in patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (recommended dose 2.5 mg rivaroxaban tablets [bid])."
16058054|NCT02468102|Drug|Standard of care drugs|For DVT/PE treatment and SPAF, standard of care is treatment with the most widely used vitamin K antagonist, phenprocoumon, and for the secondary prevention of ACS, standard of care is antiplatelet drug(s) such as low-dose acetylsalicylic acid, clopidogrel, dipyridamole, prasugrel, ticlopidine and ticagrelor.
16058055|NCT02468089|Drug|Carbepenem|
16058056|NCT02468089|Drug|Albumin|
16058057|NCT02468089|Drug|GMCSF (of Granulocyte-Monocyte Colony-Stimulating Factor) .|
16058058|NCT02468076|Device|Radiofrequency ablation (StarMed)|Radiofrequency ablation into bile duct
16058059|NCT02468063|Drug|Low dose terlipressin|Terlipressin-2mg (low dose )
16058060|NCT02468063|Drug|Noradrenaline|Noradrenaline at 7.5 mcg/min, maximum of 60mcg/min. stepped up every 15 min
16058061|NCT02468063|Drug|Noradrenaline|Noradrenaline- 3.75 mcg/min to 30 mcg/min. stepped up every 15 min
16061713|NCT02442687|Drug|JKB-121: 10 mg twice daily|
16058062|NCT02468050|Behavioral|Moderate intensity exercise training|6 weeks of moderate intensity exercise training (50 - 75% of heart rate reserve). Sessions are facility and home based and include cardiovascular warm-up, cardiovascular training, muscular conditioning, and flexibility exercises.
16058063|NCT02468050|Behavioral|Self Management of exercise|In addition to the 6 week exercise program (refer to Exercise Treatment Group), participants randomly assigned to the Self Management Group will learn strategies for the self management of exercise.
16058064|NCT02468037|Procedure|Phlebotomy|Patients donate blood until tissue iron levels are in the lowest quartile of normal.
16058065|NCT02468024|Procedure|Lung Surgery|Sublobar Lung Resection
16058066|NCT02468024|Radiation|Radiation therapy|Stereotactic Ablative Radiotherapy, 54 Gy in 3 fractions
16058067|NCT02468011|Other|vibration|vibration will be applied at 35 Hz
16058068|NCT02467998|Device|NPWT|SVAP polyurethane foam, RENASYS foam, RENASYS gauze, AMD gauze, VAC white sponge, VAC black sponge, applied with various NPWT devices, in addition to various dressings to protect wound edges
16058069|NCT02467985|Procedure|FIGARO|flow of insufflation set to 2-3L / min. Once the intervention is complete, the CO2 insufflation is discontinued, accessories trocars are removed under direct vision and the incisions the sites of these trocars will be closed with or without fascial closure according to the standard display. Patients will be placed in the Trendelenburg position 30 degrees, head tilted down. The umbilical trocar is opened. A suction is inserted into the trocar, taking care to stay inside the jacket of the trocar. Active suction gas will during lung recruitment. This maneuver will be performed by the anesthesiologist who apply 5 subsequent forced breaths, up to 40 cm H2O pressure, taking care to maintain the insufflation last 5 seconds. Once completed, the suction will be removed, the laparoscope is inserted into the trocar to verify the absence of trauma to underlying structures. The patient will be given to neutral at the end of the procedure.
16058070|NCT02467972|Dietary Supplement|Ready-to-eat frozen soups added unripe banana flour|Ready-to-eat frozen soups added unripe banana flour (18 portions; 3 times/week)
16058071|NCT02467972|Dietary Supplement|Ready-to-eat frozen soups added maltodextrin|Ready-to-eat frozen soups added maltodextrin (18 portions; 3 times/week)
16058072|NCT02467972|Dietary Supplement|Ready-to-eat frozen soups added inulin|Ready-to-eat frozen soups added inulin (18 portions; 3 times/week)
16058073|NCT02467972|Dietary Supplement|Ready-to-eat frozen soups added nisin|Ready-to-eat frozen soups added nisin (18 portions; 3 times/week)
16058074|NCT02467946|Drug|Adcetris-Levact|Association of Adcetris (1.2 mg/kg intravenously every 3 weeks) with Levact (90 mg/m2/day intravenously for 2 days every 3 weeks) during at least 6 cycles.
16058075|NCT02467933|Other|Placebo letter|The placebo letter describes a new rule in Medicare that requires prescribers to enroll in Medicare
16058076|NCT02467933|Other|Initial Informative letter|The intervention is a letter that describes the Seroquel prescribing activity of the individual in comparison to a peer group of similar prescribers. It highlights the fact that the prescriber's activity is highly unlike her peers.
16058077|NCT02467933|Other|Followup Informative Letter|The followup informative letter is identical to the initial informative letter except it provides an update on more recent prescribing rather than a description of earlier prescribing.
16058078|NCT02467920|Drug|glargine + exenatide|glargine ( once-daily subcutaneous injection at bedtime) combination with exenatide (subcutaneous injection, twice-daily)
16058079|NCT02467920|Drug|aspart 30|aspart 30 ( subcutaneous injection, twice daily)
16058080|NCT02467907|Drug|Bevacizumab|Intravenous (i.v.) administration of 15 mg/kg bevacizumab once every 3 weeks
16058081|NCT02467907|Drug|Carboplatin|Administration of carboplatin at 5 milligrams per milliliter*minute (mg/mL*min) on Day 1 every 3 weeks for at least 6 cycles
16058082|NCT02467907|Drug|Paclitaxel|Administration of paclitaxel at a dose of 175 milligrams per square meter (mg/m^2) on Day 1 every 3 weeks for at least 6 cycles
16058083|NCT02467894|Other|Group-based Care|There will be self-care activities, blood pressure measurements and other vitals, including discussion of specific topics initiated by the participants.
16058084|NCT02467881|Behavioral|Physical Activity Increase (GLB-MOD)|"The Group Lifestyle Balance (GLB) program was adapted from the original DPP lifestyle intervention. As in the original DPP lifestyle program, the GLB goals are to achieve and maintain a 7% weight loss, and to safely and progressively increase physical activity to 150 minutes/week of moderately intense physical activity similar to a brisk walk.
~The curriculum will be administered in intervention groups with an average of 10-15 individuals per group; sessions will be conducted by trained coaches, with participants attending 22 sessions over one year.
~The two intervention arms will only differ in the aerobic activity portion of the intervention, which is covered in sessions #4, #10 and 19 as well as participant record keeping and goal setting in regards to activity/inactivity progression."
16058085|NCT02467881|Behavioral|Sedentary Time Decrease (GLB-SED)|"As in the original DPP, the GLB goal for weight is to achieve and maintain a 7% weight loss. For this intervention arm, instead of focusing on increasing moderate physical activity, the GLB curriculum will be adapted to address decreasing sitting time. Participants will have a goal of decreasing sitting time by 45 minutes/day. The curriculum will be administered in intervention groups with an average of 10-15 individuals per group; sessions will be conducted by trained coaches, with participants attending 22 sessions over one year.
~The two intervention arms will only differ in the aerobic activity portion of the intervention, which is covered in sessions #4, #10 and 19 as well as participant record keeping and goal setting in regards to activity/inactivity progression."
16058086|NCT02467881|Other|6-month delayed (DELAYED)|Individuals assigned to 6 month delay will wait for 6 months from baseline to be randomly assigned to one of the two interventions and will begin intervention at that time. During the waiting period they will receive health information newsletters.
16058087|NCT02467868|Biological|MYL-1401H|During each chemotherapy cycle MYL-1401H (6 mg) is administered s.c. 24 hours after chemotherapy.
16058088|NCT02467868|Biological|Neulasta|During each chemotherapy cycle Neulasta (6 mg) is administered s.c. 24 hours after chemotherapy.
16058089|NCT02467855|Other|No Intervention|No intervention was administered in this study.
16058090|NCT02467842|Biological|NBP607-QIV|Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine containing 4 virus strains; A/H1N1, A/H3N2, B/Yamagata, B/Victoria
16058091|NCT02467842|Biological|NBP607-Y|Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Yamagata
16061714|NCT02442687|Drug|Placebo|
16058092|NCT02467842|Biological|NBP607-V|Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Victoria
16058093|NCT02467829|Device|Increase in handle height|Elbow flexion is measured with the child standing in their walker using an electronic goniometer. Approximately 10° of elbow flexion is current recommended practice. 30° and 50° are increased handle heights.
16058094|NCT02467816|Behavioral|SmartMeal application|The SmartMeal application is a smartphone application that will allow students to pre-order school meals, receive nutrition information about school meals, and provide feedback about school meals to Student Nutrition Services.
16058095|NCT02467816|Behavioral|Distributed points of sale|To increase points of sale for school meals (outside the cafeteria), school meals will be sold at hot and cold mobile food carts and vending machines throughout the school.
16058096|NCT02467816|Behavioral|Staff wellness curriculum|A wellness curriculum will be implemented that encourages teachers and staff members to eat school meals and promote them to students.
16058097|NCT02467803|Other|Scapula mobilization|
16058098|NCT02467803|Other|Shoulder ROM exercises|
16058099|NCT02467790|Drug|PEX168|PEX 168: 200µg,Subcutaneous,one time.
16058100|NCT02467777|Device|Bair Hugger|
16058101|NCT02467777|Device|VitaHeat|
16058102|NCT02467764|Other|Retrospective study|
16058103|NCT02467738|Radiation|Brachytherapy|Undergo brachytherapy with Cesium-131
16058104|NCT02467738|Drug|Cesium-131|Undergo brachytherapy with Cesium-131
16058105|NCT02467738|Procedure|Conventional surgery|Undergo surgical resection
16058106|NCT02467725|Other|Dynamic culture platform|Patients will have their cohort of embryos split in half. Half will be cultured in the dynamic platform and the other half cultured in static.
16058107|NCT02467686|Behavioral|WHOQOL questionnaire|WHO defines Quality of Life as individuals perception of their position in life in the context of the culture and value systems in which they live and in relation to their goals, expectations, standards and concerns.
16058108|NCT02467686|Behavioral|FSFI questionnaire|FSFI questionnaire application for evaluation of sexual function at the first visit, 3-month and 6-month follow-up.
16058109|NCT02467686|Behavioral|kupperman scale|Kupperman scale is a tool to help evaluate the severity of menopausal symptoms
16058110|NCT02467686|Drug|Cimicifuga racemosa|The Cimicifuga racemosa effects on the sexuality of women with Breast cancer
16058111|NCT02467686|Drug|tamoxifen|The Cimicifuga racemosa effects on the sexuality of women with Breast cancer using tamoxifen
16058112|NCT02467686|Drug|exemestane|The Cimicifuga racemosa effects on the sexuality of women with Breast cancer using aromatase inhibitor.
16058113|NCT02467673|Drug|Micronized estradiol + progesterone|Administration of micronized estradiol + progesterone daily by a metered-dose pump during 12 weeks in postmenopausal women with no clinical evidence of cardiovascular disease.
16058114|NCT02467673|Drug|Nanoparticulate estradiol + progesterone|Administration of nanoparticulate estradiol + progesterone daily by a metered-dose pump during 12 weeks in postmenopausal women with no clinical evidence of cardiovascular disease.
16058115|NCT02467660|Behavioral|Mindfulness Meditation|Using study-provided iPod device to listen to guided meditations daily
16058116|NCT02467660|Behavioral|Health & Wellness Education|Using study-provided iPod device to listen to educational podcasts daily
16058117|NCT02467647|Drug|Thalidomide|
16058118|NCT02467647|Drug|HLJDT|
16058119|NCT02467634|Biological|HuCNS-SC sub-retinal transplantation|HuCNS-SC sub-retinal transplantation in subjects with bilateral GA AMD
16058120|NCT02467621|Drug|Pantoprazole|40 mg x 1 daily intravenously from ICU admission to ICU discharge
16058121|NCT02467621|Other|Saline (0.9%)|10 ml of isotonic saline x 1 daily intravenously from ICU admission to ICU discharge
16058122|NCT02467608|Drug|Isoniazid with HUEXC030 and RZE|Subjects will receive oral study drug daily in accordance with the following regimen, that is, INH, RMP, PZA, and EMB for the first 2 months followed by INH, RMP and EMB (if medically indicated) daily for 4 additional months
16058123|NCT02467608|Drug|HRZE|the same as experimental group,without the excipient of HUEXC030 only
16058124|NCT02467595|Drug|Rocuronium bromide 0.15 mg kg-1|Rocuronium bromide 0.15 mg kg-1 was injected at I.V. line to patients (R 0.15 group), as muscle relaxants during anesthesia for adenotonsillectomy.
16058125|NCT02467595|Drug|Rocuronium bromide 0.3 mg kg-1|Rocuronium 0.3 mg kg-1 was injected at I.V. line to patients (R 0.3 group), as muscle relaxants during anesthesia for adenotonsillectomy.
16058126|NCT02467595|Drug|Fentanyl|Fentanyl 2 mcg kg-1 was injected at I.V. line to patients
16058127|NCT02467595|Drug|Propofol|Propofol 2.5 mg kg-1 was injected at I.V. line to patients
16058128|NCT02467595|Drug|Sevoflurane|After mask ventilation with 5 vol% sevoflurane in 100% oxygen for 2 minutes, tracheal intubation was done.
16058129|NCT02467582|Drug|Aspirin|Aspirin 100 mg daily
16058130|NCT02467582|Drug|Placebo|Placebo
16058131|NCT02467569|Drug|Hemay020|
16058132|NCT02467556|Drug|Morphine, memantine|Morphine up to 30 mg per day orally and memantine up to 40 mg per day orally if tolerated for 10 weeks.
16058133|NCT02467556|Behavioral|Psychological intervention|To help patients shift perspective from pain and CRPS-symptoms, to increase body awareness, to create vivid imagenary, to increase the use of a CRPS hand with mindfulness exposure exercises, to increase flexibility in behavioral repertoire, to explore the fusion of emotions, automatic cognitions and learned responses and to help patients to integrate new skills in their lives.
16058134|NCT02467556|Other|Physiotherapy intervention|Graded motor imagenary with group and individual weekly sessions with daily practices at home.
16058135|NCT02467543|Other|20% Ethanol|Unmedicated 20% Ethanol
16058136|NCT02467543|Other|Viburnum opulus 3X|Viburnum opulus 3X in a vehicle of 20% ethanol.
16058137|NCT02467530|Other|AGE|
16058138|NCT02467517|Drug|Ketamine|
16058139|NCT02467517|Drug|Magnesium Sulfate|
16058140|NCT02467517|Drug|placebo : sodium chloride|
16058141|NCT02467504|Drug|hrIL-2 active|hrIL-2 active (1 million U doses of hrIL-2s.c.injection)
16058142|NCT02467504|Drug|hrIL-2 placebo|hrIL-2 placebo (1 million U doses of hrIL-2 placebo s.c.injection)
16058143|NCT02467504|Drug|MTX|Methotrexate (oral administration)
16058144|NCT02467504|Drug|Folic Acid|Folic Acid (oral administration)
16058146|NCT02467491|Device|Jintronix|The participants will perform light exercises using the Jintronix software. Jintronix is an easy-to-use virtual physical activity platform designed for physical and occupational therapy. It combines common exercise movements, virtual games and motion sensing cameras to offer a fun and effective tool for physical activity.
16058147|NCT02467478|Drug|Linagliptin|5 mg tablet once daily for 12 weeks
16058148|NCT02467478|Drug|Placebo|1 tablet daily for 12 weeks
16058149|NCT02467465|Other|Physical therapy modalities|Massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles.
16058150|NCT02467465|Device|Invasive Physical therapy modalities|Dry needling added to massage, movilization of ankle dorsiflexion and improve flexibility with stretching of calf muscles.
16058153|NCT02467439|Other|Notification cards|detection of AHI, contract partner notification, and social contact referral to find persons unaware of their HIV infection.
16058154|NCT02467426|Drug|Chemotherapy|intraarterial infusion of cisplatin and mithoxantrone
16058155|NCT02467413|Drug|BAC|(vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof)
16058156|NCT02467413|Other|BAC Matched Vehicle|BAC Matched Vehicle
16058157|NCT02467400|Drug|Atenolol|beta blocker
16058158|NCT02467400|Drug|Nebivolol|beta blocker
16058159|NCT02467400|Drug|Propranolol|beta blocker
16058160|NCT02467400|Drug|placebo|placebo
16058161|NCT02467387|Drug|Allogeneic Mesenchymal Bone Marrow Cells (aMBMC)|One time infusion Allogeneic Mesenchymal Bone Marrow Cells (aMBMC) 1.5 million cells/kg.
16058162|NCT02467387|Drug|Lactated Ringer's Solution|One time infusion 1.5mL/kg
16058163|NCT02467374|Behavioral|Behavior Therapy|"BT for OCD focuses primarily on exposure with response prevention (ERP). ERP involves gradual exposure to anxiety-provoking situations (things or situations that frighten or disturb some people), and will help to prevent compulsions (repetitive behaviors)."
16058164|NCT02467361|Drug|BBI608|Patients in this trial will receive BBI608 at assigned dose-levels according to the study arm the patient is enrolled into. BBI608 Dose Level 1: 240 mg twice daily, Dose Level 2: 480 mg twice daily. The assigned dose of BBI608 will be administered twice daily with approximately 12 hours between doses.
16058165|NCT02467361|Drug|Ipilimumab|Ipilimumab 3 mg/kg is administered intravenously over 90 minutes every 21 days for a total of 4 doses.
16058166|NCT02467361|Drug|Nivolumab|Nivolumab 3 mg/kg is administered as an intravenous infusion over 60 minutes every 14 days.
16058167|NCT02467361|Drug|Pembrolizumab|Pembrolizumab 2 mg/kg is administered as an intravenous infusion over 30 minutes once every 21 days.
16058168|NCT02467348|Drug|Albumin|Intravenous albumin 8 gms/L of ascitic fluid
16058169|NCT02467348|Drug|Ascitic fluid|
16058170|NCT02467335|Drug|BMS-663068|BMS-663068
16058171|NCT02467322|Drug|Albumin|MVP of less than 5 liters with iv albumin at a dose 8 gms/L of ascitic fluid.
16058172|NCT02467322|Drug|ascitic fluid|
16058173|NCT02467296|Other|Dietary plan with controlled amount of Sodium|Dietary plan with 1.5 gr vs 3 gr of Sodium
16058174|NCT02467283|Genetic|Genom-based whole-genome transcriptomic|Gene expression profiling is a powerful means of generating comprehensive genome-level data sets.
16058175|NCT02467270|Drug|Ponatinib|Tablet, taken orally once daily.
16058176|NCT02467257|Dietary Supplement|Gum Arabic|oral ingestion of 30 gram every day for 12 weeks
16058177|NCT02467244|Drug|Levothyroxine|At first visit, after taking detailed history including baseline symptomatology, clinical evaluation, and laboratory investigation, treatment will be started with levothyroxine (50 microgram/day). The dosage of levothyroxine (LT4) will be adjusted (at 4th and 8th week) in an attempt to keep the serum FT4 and TSH concentrations within the normal range. After 12 weeks, all the patients will be followed up, clinical and laboratory tests will be repeated.
16058178|NCT02467218|Other|Hyperbaric Oxygen Treatment|Baseline and follow up fMRI and Oxygen treatment, 90 minutes, once daily, five times a week for 8 consecutive weeks in the hyperbaric chamber (40 treatments with 100% oxygen at 2.0 ATA)
16058179|NCT02467205|Other|pedometer supported walking and education|"A Physical activity; pedometer will be given to each person in the intervention group at the first education session. Participants will be encouraged to use the pedometer for a 6 month period.
~The strength exercises will be performed at home. Education will incorporate the behavioural change techniques (BCTs) known to be effective in increasing physical activity (Goal setting,Self-monitoring of behaviour,Feedback on outcomes of behaviour,Problem solving,Relapse Prevention (RP) and social support)."
16058180|NCT02467192|Device|Low dose CT|Thoracic CT scan will be performed within the first 48-72 hours of admission, with an analysis and conclusion by a radiologist
16058181|NCT02467179|Device|Amigo™ Robotic Catheter Manipulation|"Ablation is a standard procedure that patients may undergo for the atrial flutter.
~In this study, this group will be assigned to robotic catheter manipulation."
16058182|NCT02467179|Device|Manual Catheter Manipulation|"Ablation is a standard procedure that patients may undergo for the atrial flutter.
~In this study, this group will be assigned to manual catheter manipulation."
16058183|NCT02467166|Device|Circa™ Probe|The Circa™ probe will be used to monitor esophageal temperature and guide ablation power and duration during the RFCA procedure. Following ablation esophagoscopy will be performed to assess for esophageal lesions.
16058184|NCT02467153|Other|RET|"RET: A supervised group exercise programme with a maximum of n=10-12 participants per group to be attended 3 times per week for 6 months.
~The RET programme includes elements of current established programmes for falls prevention/ core stability (i.e., OTAGO, PEPPI) and will tailored to a range of abilities within the target group.
~Vitamin D3 supplementation: vitamin D3 given orally as tablets at a dosage of 800 IU/day for 6 months."
16058185|NCT02467153|Dietary Supplement|Placebo|Placebo given orally as tablets; 1 tablet per day for 6 months.
16058186|NCT02467153|Dietary Supplement|Vitamin D3|Placebo given orally as tablets; 800 IU as 1 tablet per day for 6 months.
16058187|NCT02467140|Device|Parietex ProGrib self-fixating mesh|Laparoscopic transabdominal preperitoneal inguinal hernioplasty using the Parietex ProGrib self-fixating mesh.
16058188|NCT02467140|Device|Tack fixation|Laparoscopic transabdominal preperitoneal inguinal hernioplasty using the Parietex ProGrib self-fixating mesh using tack fixation.
16058387|NCT02465801|Drug|HSA-GCSF 1.2 mg|Human Serum Albumin GCSF 1.2mg at day 3 and Day 7
16058189|NCT02467127|Dietary Supplement|vitamin D supplementation|In patients with headache and with low vitamin D plasma levels, will be administered a vitamin D supplementation.
16058190|NCT02467114|Device|Transcranial magnetic stimulation (TMS)|This method will be applied to measure cortical excitability and as an interference approach; real TMS stimulation will be compared with sham stimulation and no stimulation
16058191|NCT02467114|Device|Sham coil stimulation|Stimulation with a sham coil as a comparison
16058192|NCT02467114|Other|Control without stimulation|
16058193|NCT02467101|Other|Corticosteroid/Saline|"Corticosteroid/Saline
~Two groups were defined: group A and group B.
~Group A receives treatment with intralesional triamcinolone acetonide on the right half-head and placebo on the left half-head
~Group B receives administration of intralesional triamcinolone acetonide on left half-head and placebo on the right half-head.
~Same patient will be injected with intralesional triamcinolone acetonide and a saline solution.
~Each patient will be injected on half-head."
16058194|NCT02467088|Other|Individualised Homeopathic Remedy|Each participant will receive an individualised homoeopathic remedy prescribed according to the individualised symptoms of their PMS.
16058195|NCT02467075|Drug|Iopamidol 300 (Contrast)|Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, max 125 mL) with their CT scan
16058196|NCT02467075|Drug|Placebo (Normal Saline)|Patients will be randomized to receive IV normal saline (1.25 mL/kg, max 125 mL) with their CT scan
16058197|NCT02467062|Device|MRI|MRI measurement to evualuate for 4D blood flow pattern
16058198|NCT02467049|Device|ECG-guided insertion of PICC|Comparison of placement of a PICC (Peripherally Inserted Central Catheter) by ECG-guidance vs. ULTRASOUND-guidance
16058199|NCT02467049|Device|ULTRASOUND-guided insertion of PICC|Comparison of placement of a PICC (Peripherally Inserted Central Catheter) by ECG-guidance vs. ULTRASOUND-guidance
16058200|NCT02467036|Behavioral|Family Based Behavioral Treatment|The intervention for both groups will be a 4-month Family-Based Behavioral Treatment (FBT), which includes dietary changes, physical activity changes, and behavioral therapy. Treatment is provided in separate parent and child groups. Families will learn to reduce caloric consumption and increase caloric expenditure (physical activity). Behavior therapy includes stimulus control, self-monitoring, goal setting and contracting, parenting skills, skills for managing high-risk situations, and maintenance and relapse prevention. Families will self-monitor caloric intake, breakfast consumption, physical activity, and hunger and satiety throughout the day.
16058201|NCT02467023|Device|Muscle stimulation with Niveus medical stimulator|Subjects will be treated five days per week, for 30 minutes each session. Muscle stimulation will be conducted for four seconds every 15 seconds, thus the subjects will undergo four stimulations per minute. Muscle stimulation will be adjusted until there is a visible or palpable bilateral quadriceps contraction.
16058202|NCT02467023|Device|measurement of maximal isometric twitch strength|Quadriceps strength will be measured on the initial day of study approximately every seven days thereafter and on the final day of study participation. For this measurement, patients will remain supine in their bed and the dominant leg will be placed on a frame that will hold the knee at a 60° angle. A cuff will be placed around the ankle and connected to an electronic dynamometer that will record the force generated during the stimulation. The muscle will be stimulated to contract with magnetic stimulators placed over the body of the quadriceps muscle and stimulated at 100% of power output.
16058203|NCT02467023|Procedure|Muscle Biopsy|"This procedure will be done at the end of participation in the study.The biopsy will be performed with a sterile needle, which will be inserted through the skin. A skin incision (approximately 1/4 long) will be made in order to insert the needle. The biopsy procedure yields two small pieces of muscle tissue (200 mg total), each about half the size of the eraser on a pencil. After the biopsy is taken, the incision will be closed using a steri-strip bandage (no stitches are required), and a sterile dressing will be placed over the site to reduce the risk of bleeding."
16058204|NCT02467023|Drug|Muscle Biopsy Medication: Lidocaine|Biopsy samples will be obtained under local anesthesia (up to 20 milliliters of 1% Lidocaine administered subcutaneously). Lidocaine, a drug to numb your pain will be injected into the skin and muscle tissue. The injection of the numbing medication will be slightly painful and is similar to receiving a shot into your arm for a vaccination. This medication numbs the skin and muscle so that you do not feel pain when the biopsy is obtained.
16058205|NCT02467023|Drug|Muscle Biopsy Medication: Versed|Prior to starting the muscle biopsy, you can receive a drug, Versed, to help you relax during the procedure. 1-2 milligrams of Versed will be administered intravenously (in the vein) through an existing peripheral or central intravenous catheter. This procedure drug is given as needed and can be repeated one time as needed.
16058206|NCT02467023|Drug|Muscle Biopsy Medication: Fentanyl|Prior to starting the muscle biopsy, you can receive a drug, Fentanyl, to make you more comfortable during the procedure. 50-100 micrograms of Fentanyl will be administered intravenously (in the vein) through an existing peripheral or central intravenous catheter. This procedure drug is given as needed and can be repeated one time as needed.
16058207|NCT02467023|Other|Blood and Urine Sampling|Blood and urine samples will be obtained and examined for markers inflammation and muscle catabolism. Sampling will occur at time of entry into study, and then once every 2-4 days and on the final day of participation or the last day of study (day 28). Peripheral blood will be collected from an existing venous line, or by venipuncture, if required. Urine will be collected from an existing catheter or if the patient is able to void on their own then we will provide a specimen cup. There will be no more than 14 ml of blood drawn at any given time point and a collection of 15 ml of urine at each time point.
16058208|NCT02467023|Device|ineffective muscle stimulation|An investigator will perform range of motion on both legs, five days per week. The range of motion activity will include the investigator helping you bend and straighten each knee approximately 12 times. Rotation of the leg at the hip will also be performed by bending your knee and gently rotating your upper leg in a clockwise and counterclockwise motion. The range of motion will be performed on each leg and repeated five days per week.
16058243|NCT02466802|Drug|Regorafenib|Combination of regorafenib and of sildenafil when given to patients with advanced solid tumors. Regorafenib Administration and Treatment Schedule. Regorafenib will be taken orally once daily for the first 21 days of each 28-day cycle. Regorafenib will not be taken on the last 7 days of each cycle. Patients will be instructed as follows: Take regorafenib once daily with a low fat meal that contains less than 30% fat. Take the regorafenib tablets at about the same time each day. Swallow the tablets whole.
16058488|NCT02465151|Other|Protein-based beverage|protein-based beverage
16058209|NCT02467010|Drug|Bortezomib|"Re-induction chemotherapy with bortezomib, cyclophosphamide and dexamethasone. All patients with first relapse or primary refractory multiple myeloma and bortezomib naive will be given 6 cycles of re-induction therapy. Patients will be evaluated for response after cycle 3 and 6.
~Maintenance therapy with bortezomib and cyclophosphamide Maintenance therapy with bortezomib and cyclophosphamide will start at 4 weeks after the last cycle of re-induction chemotherapy if ANC ≥ 2.0 x 109/l and platelets > 75 x 109/l. Bortezomib is administered once every other week and cyclophosphamide (50 mg) every day for 1 year or until progression or death of any cause."
16058210|NCT02467010|Drug|Cyclophosphamide|"Re-induction chemotherapy with bortezomib, cyclophosphamide and dexamethasone. All patients with first relapse or primary refractory multiple myeloma and bortezomib naive will be given 6 cycles of re-induction therapy. Patients will be evaluated for response after cycle 3 and 6.
~Maintenance therapy with bortezomib and cyclophosphamide Maintenance therapy with bortezomib and cyclophosphamide will start at 4 weeks after the last cycle of re-induction chemotherapy if ANC ≥ 2.0 x 109/l and platelets > 75 x 109/l. Bortezomib is administered once every other week and cyclophosphamide (50 mg) every day for 1 year or until progression or death of any cause."
16058211|NCT02467010|Drug|Dexamethasone|"Re-induction chemotherapy with bortezomib, cyclophosphamide and dexamethasone. All patients with first relapse or primary refractory multiple myeloma and bortezomib naive will be given 6 cycles of re-induction therapy. Patients will be evaluated for response after cycle 3 and 6.
~Maintenance therapy with bortezomib and cyclophosphamide Maintenance therapy with bortezomib and cyclophosphamide will start at 4 weeks after the last cycle of re-induction chemotherapy if ANC ≥ 2.0 x 109/l and platelets > 75 x 109/l. Bortezomib is administered once every other week and cyclophosphamide (50 mg) every day for 1 year or until progression or death of any cause."
16058212|NCT02466997|Drug|tacrolimus|tacrolimus 0.1% ointment applied twice a day for the experimental group during 24 weeks placebo ointment applied twice a day for the control group during 24 weeks
16058213|NCT02466997|Drug|Placebo|
16058214|NCT02466984|Drug|metoclopramide intravenous|Administration route
16058222|NCT02466958|Drug|levomilnacipran|antidepressant
16058223|NCT02466958|Drug|Placebo|an inactive drug
16058224|NCT02466945|Device|V063B-DP3003|The medical device V063B-DP3003 has been developed to relieve and decrease dentinal hypersensitivity in patients by creating a film around the sensitive tooth in order to prevent pain. Application modalities: apply a pea size amount of product (around 0.5g) onto each of the sensitive teeth, 3 times a day, by gentle massage with clean finger after each brushing of teeth. Do not rinse
16058225|NCT02466932|Device|Galilei Dual-Scheimpflug Analyzer|Measuring of Anterior Segment by Galilei Dual-Scheimpflug Analyzer
16058226|NCT02466919|Drug|Pantoprazole|H. pylori eradication therapy
16058227|NCT02466919|Drug|Amoxicillin|H. pylori eradication therapy
16058228|NCT02466919|Drug|Metronidazole|H. pylori eradication therapy
16058229|NCT02466919|Drug|Levofloxacin|H. pylori eradication therapy
16058230|NCT02466919|Drug|Clarithromycin|H. pylori eradication therapy
16058231|NCT02466906|Drug|rhGM-CSF|rhGM-CSF was injected subcutaneously of 3± 0.3ug/kg/d per day for 5 days before and 2 days after surgery. During adjuvant therapy of XELOX, rhGM-CSF was continuous injected for 6 days when finishing each cycle of chemotherapy (from d15) or stopped when ANC>20.0X109/L.
16058232|NCT02466906|Drug|placebo|Placebo was injected subcutaneously of 3± 0.3ug/kg/d per day for 5 days before and 2 days after surgery. . During adjuvant therapy of XELOX, placebo was continuous injected for 6 days when finishing each cycle of chemotherapy (from d15).
16058233|NCT02466893|Other|Adapt/Standard Stent Retriever (SR) Group|If the patient is randomized to mechanical thrombectomy, the groin puncture to initiate the procedure should occur within 1 hour of the clinical imaging used to determine trial candidacy. An introducer sheath will be placed in the femoral artery. Diagnostic angiography is initially performed via the transfemoral approach with catheterization of the carotid artery appropriate to the patient's presenting symptoms. Once thrombus in the appropriate vessel is identified, the thrombectomy procedure will be initiated.
16058234|NCT02466880|Device|Telemedicine|A diabetes self-management and education program delivered via telemedicine
16058235|NCT02466880|Other|Usual care|A 15-30 minute diabetes self-management session. Continued care, as usual, from their primary care provider throughout duration of active 12 month intervention period.
16058236|NCT02466867|Drug|Naftin® Cream, 2% (younger pediatric cohort)|Approximately 3 grams of Naftin® Cream, 2% ist to be applied once per day for subjects aged 2 to 5 years, 11 months.
16058237|NCT02466867|Drug|Naftin® Cream, 2% (older pediatric cohort)|Approximately 4 grams of Naftin® Cream, 2% ist to be applied once per day for subjects aged 6 to 11 years, 11 months.
16058238|NCT02466841|Procedure|Cubital tunnel release|Patients undergoing cubital tunnel release for ulnar nerve compression at elbow
16058239|NCT02466828|Drug|Feraheme®|Drug will be diluted in 50 cc normal saline and infused over 15-60 minutes depending on patient condition.
16058240|NCT02466815|Drug|JNJ-42756493 Current Clinical Formulation (G-018)|JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as current clinical formulation (G-018) in treatment A in either period 1, 2 or 3 as per treatment sequence.
16058241|NCT02466815|Drug|JNJ-42756493 Prototype Formulation I (G-025)|JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as Prototype Formulation I (G-025) in treatment B in either period 1, 2 or 3 as per treatment sequence.
16058242|NCT02466815|Drug|JNJ-42756493 Prototype Formulation II (G-025)|JNJ-42756493 10 milligrams (2 tablets of 5 mg each) will be administered as Prototype Formulation II (G-025) in treatment C in either period 1, 2 or 3 as per treatment sequence.
16058244|NCT02466802|Drug|Sildenafil Citrate|Combination of regorafenib and of sildenafil when given to patients with advanced solid tumors.Sildenafil Administration and Treatment Schedule. Sildenafil will be taken orally once daily at the same time the regorafenib dose is taken for the first 21 days of each 28-day cycle. Sildenafil will not be taken on the last 7 days of each cycle.
16058245|NCT02466776|Device|Absorbable subcuticular suture|Patients will receive absorbable subcuticular suture for skin closure at time of cesarean section.
16058246|NCT02466776|Device|Stainless steel staples|Patients will receive stainless steel staples for skin closure at time of cesarean section.
16058247|NCT02466763|Procedure|Cochlear implant surgery|Surgical placement of a cochlear implant device.
16058248|NCT02466750|Biological|Western Equine Encephalitis (WEE) Vaccine|Western Equine Encephalitis (WEE) Vaccine, Inactivated, Dried, TSI-GSD 210, Lot 3-1-92
16058249|NCT02466737|Procedure|no axillary surgery versus SLNB|in cases with newly diagnosed breast cancer and clinically negative axillary status
16058250|NCT02466737|Procedure|SLNB versus completion ALND|in cases with 1-3 macrometastases in sentinel lymph nodes
16058251|NCT02466724|Device|Aiddly (Web Site)|A website designed to better educate patients on how to prepare for their colonoscopies
16058252|NCT02466711|Drug|Relamorelin|Double blind RM-131 will be delivered three times by injection during the course of the study
16058253|NCT02466711|Drug|Placebo|Double blind Placebo will be delivered three times by injection during the course of the study
16058254|NCT02466698|Procedure|Intestinal Lavage|A nasojejunal tube and fecal management system will be inserted. Intestinal lavage with PEG is initiated and increased to a goal rate of 400cc/hour to a total of 8L of PEG. In the absence of an ileus, lavage should be initiated at 200cc/hr. Tolerance is confirmed if the rectal effluent volume is ≥50% of the lavage volume over the first 6 hours and no emesis has developed. If the consulting surgical service suspects a significant ileus, the lavage is initiated at 100cc/hr. If tolerance is confirmed the lavage rate is increased in a stepwise fashion. Antibiotic regimen will consist of Vancomycin 500mg via nasojejunal every 6 hours and Metronidazole 500 mg IV three times daily for 14 days. PEG will be held for 2 hours after administration of Vancomycin.
16058255|NCT02466698|Drug|Vancomycin|Patients will receive standard antibiotic treatment for severe CDI. This includes an antibiotic regimen of Vancomycin 500mg orally every 6 hours and Metronidazole 500mg IV three times daily for 14 days. The standard medical care group (active comparator group) will receive the same antibiotic doses as the experimental arm of the study For both arms, indications to escalate treatment to surgical intervention will ultimately be based on the clinical assessment by the surgical service. An absolute indication for surgery is perforation. Other indications such as toxic megacolon, worsening peritonitis or biochemical profile lavage are relative indications that vary according to clinician and individual patient characteristics.
16058256|NCT02466698|Drug|PEG|Polyethylene glycol 3350, 8L in 48 hours, via a nasojejunal tube will be used to facilitate intestinal lavage.
16058257|NCT02466698|Drug|Metronidazole|Patients will receive standard antibiotic treatment for severe CDI. This includes an antibiotic regimen of Vancomycin 500mg orally every 6 hours and Metronidazole 500mg IV three times daily for 14 days. The standard medical care group (active comparator group) will receive the same antibiotic doses as the experimental arm of the study For both arms, indications to escalate treatment to surgical intervention will ultimately be based on the clinical assessment by the surgical service. An absolute indication for surgery is perforation. Other indications such as toxic megacolon, worsening peritonitis or biochemical profile lavage are relative indications that vary according to clinician and individual patient characteristics.
16058258|NCT02466685|Drug|JNJ-18038683|JNJ-18038683 10-20 mg/day for 8 weeks
16058259|NCT02466672|Other|none - observational only|
16058260|NCT02466659|Device|CIAO therapy Amblyz glasses|3-hour CIAO Therapy Amblyz glasses
16058261|NCT02466646|Drug|Klorhex® Gel, rinse and spray|Initial periodontal treatment was performed in 2 sessions with application of chlorhexidine to the intra-oral niches within 24 hours (Klorhex® Gel 1% for 10 minutes, Klorhex® Spray 0,2% and Klorhex® rinse 0,2% for 3 weeks).
16058262|NCT02466646|Procedure|Conventional IPT|Initial periodontal treatment was performed in a quadrant-wise manner at 1-week intervals.
16058263|NCT02466646|Procedure|Full-mouth IPT|Initial periodontal treatment was performed in 2 sessions within 24 hours.
16058264|NCT02466633|Other|In-hospital cardiac monitoring method|Method for monitoring hospitalized patients at risk for cardiac arrhythmias (non-ICU)
16058265|NCT02466607|Device|RETeval color flicker ERG|Flicker ERGs obtained to 56 CIE 1931 (created by the International Commission on Illumination (CIE) in 1931) colors series. White flash of 0,33, 0,33 was used for comparison.
16058266|NCT02466607|Device|RETeval dilated versus un-dilated flicker ERG|Two series of white flashes: 3,0 cd/m2/sec and Trolands equivalent assuming 3,7 mm pupil size, delivered at 3 min interval over 30 min.
16058267|NCT02466607|Other|pupil dilation|Pupil will be dilated using Proparacaine 0.5% and Tropicamide 0.5%
16058268|NCT02466594|Device|Hilotherm Clinic®|Controlled Thermoregulation using a water circulation based system (Hilotherm Clinic®). Controlled Thermoregulation with Hilotherm Clinic® - Flap Temperature is altered by passive warming (dressing), active warming (38 C) and active cooling (10 C) each for 60 minutes following free flap transfer in every subject at the day of surgery and the following three days
16058269|NCT02466581|Drug|Sulphasalazine + Hydroxychloroquine OR Prednisolone|Methotrexate: 25mg/week. SSZ: 2 g/day. HCQ: 35 mg/kg/week (Finland and Denmark) Methotrexate: 25mg/week. Prednisolone 20 mg/day tapered in 9 weeks to 5 mg/day, discontinued after 9 months. (Sweden, Norway, and Iceland)
16058270|NCT02466581|Biological|Cimzia|Certolizumab-pegol: 200 mg s.c. every other week. Methotrexate: 25mg/week
16058271|NCT02466581|Biological|Orencia|Abatacept: 125 mg s.c. every week. Methotrexate: 25mg/week
16058272|NCT02466581|Biological|RoActemra|Tocilizumab is given as 4-weekly infusions at dosage 8 mg/kg or 162 mg in solution s.c. every week. Methotrexate: 25mg/week
16058273|NCT02466568|Drug|Nivolumab|Participants will receive treatment with nivolumab as a 60-minute +/-5 minutes intravenous (IV) infusion on Day 1 and 15 of each 28-day cycle.
16058274|NCT02466568|Biological|GM.CD40L Vaccine|GM.CD40L will be injected intradermally every 2 weeks for 4 injections, then every month for 4 injections, then every 3 months until the patient is off treatment.
16058313|NCT02466282|Device|Angiography-guided PCI with bioresorbable vascular scaffold|Everolimus-eluting bioresorbable vascular scaffold (Absorb, Abbott Vascular, Santa Clara, CA, USA) was made from a bioabsorbable polylactic acid backbone which is coated with a more rapidly absorbed polylactic acid layer that contains and controls the release of the antiproliferative drug, everolimus. PCI will be performed with BVS under conventional coronary angiography without any other intravascular imaging modality.
16058489|NCT02465138|Drug|Ketorolac|Intravenous ketorolac
16058275|NCT02466555|Behavioral|Music Therapy|During the educational music therapy intervention, member(s) of the Adult Sickle Cell Disease team will share with the patients the medical information pertinent to the appointment, ask health related questions of the patients and respond to any pertinent inquiries. The Music Therapist will then engage the patients and member(s) of the Adult Sickle Cell Disease team in a music therapy intervention designed to teach and reinforce the skills and knowledge presented. These music therapy interventions may include but are not limited to original songs/rap/instrumental playing, vocal and/or instrumental improvisation, patient-contributed lyrics, mnemonics, and stress and pain reducing strategies. The music therapy interventions will be tailored to best convey the educational message.
16058276|NCT02466542|Drug|Placebo group|Patients will receive regular general anesthesia
16058277|NCT02466542|Drug|Esmolol group|Patients will receive regular general anesthesia plus esmolol infusion
16058278|NCT02466516|Drug|SEL|SEL tablet administered orally once daily
16058279|NCT02466516|Biological|SIM|Simtuzumab (SIM) 125 mg/mL single-dose vials administered subcutaneously once weekly
16058280|NCT02466503|Drug|Fluticasone propionate|Inhaled corticosteroid, pMDI
16058281|NCT02466503|Drug|Salmeterol (as xinafoate)|Beta-agonist, LABA, pMDI
16058282|NCT02466490|Drug|Fimasartan|Fimasartan tablets
16058283|NCT02466490|Drug|Fimasartan; Hydrochlorothiazide|Fimasartan plus hydrochlorothiazide fixed dose combination tablets
16058284|NCT02466477|Genetic|GeneSight Psychotropic (GEN)|Patient DNA will be collected for all subjects and measured for variations in drug target genes and in drug metabolizing genes.Recommendations for optimal choices and dose adjustments for the 33 most commonly prescribed antidepressant and antipsychotic medications will be provided to subjects randomized to the GEN arm. This pharmacogenomic-based interpretive report will be provided to treating clinicians of patients in the GEN arm of the study, allowing clinicians to use the report to support their treatment decisions.
16058285|NCT02466477|Genetic|Enhanced-GeneSight Psychotropic (E-GEN)|The E-GEN test incorporates into the existing GEN product new markers that are predictive of side effect of antipsychotic-induced weight gain (AIWG). The pharmacogenomic-based interpretive report from E-GEN will be provided to treating clinicians of patients in the E-GEN arm of the study, allowing clinicians to use the report to support their treatment decisions.
16058286|NCT02466477|Other|Treatment as Usual (TAU)|Subjects randomized to the TAU arm will also require collection of patient DNA. A pharmacogenomic-based interpretive report will be generated from GEN, however, this report is not provided to the treating clinician until completion of the study.
16058287|NCT02466464|Device|Microporous Polysaccharide Hemospheres|Two grams of Arista powder will be placed into the nose followed by four minutes of pressure and a moustache dressing.
16058288|NCT02466464|Device|Nasal Tampon|8 cm of Merocel dressing will be placed into one or both sides of your nose for the next three to five days and will then be removed by the physician.
16058289|NCT02466451|Other|Questionnaires|"For not collaborative patients, under the age of 4 years:
~Standardized questionnaire collecting anamnestic-clinical data
~Stress Parenting Index questionnaire and COPE brief questionnaire(Questionnaire assessing adaptation strategies of parents).
~For collaborative patients, over the age of 4 years:
~Standardized questionnaire collecting anamnestic-clinical data
~Fractional exhaled nitric oxide (FeNO) assessment (oral and alveolar )
~Spirometry
~6-minutes walk test (WT 6')
~Prick tests
~Children Quality of life questionnaire (KINDL questionnaire)
~Psychological test (Raven Matrices)
~Stress Parenting Index questionnaire and COPE brief questionnaire (Questionnaire assessing adaptation strategies of parents)"
16058290|NCT02466438|Drug|Piperacillin-tazobactam|"Normal renal function receiving new optimized piperacillin-tazobactam dosing regimen per age, dosing (mg/kg), duration of infusion
~Age (2-5 months): 80 mg/kg/dose of medication every 8 hours for 4 hours
~Age (≥6 months-6y): 130 mg/kg/dose of medication every 8 hours for 4 hours
~Acute Kidney injury : Dosing as prescribed by treating physician"
16058291|NCT02466425|Drug|SHP465|12.5mg and 25mg capsules (one capsule daily)
16058292|NCT02466425|Drug|Placebo|Matching placebo capsule that appear identical in size, weight, shape, color
16058293|NCT02466412|Other|CHTP 1.1 M|Single use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M)
16058294|NCT02466412|Other|mCC|Single use of subject's own menthol conventional cigarette (mCC)
16058295|NCT02466399|Drug|POLAT-001|Subconjunctival injection
16058296|NCT02466399|Drug|Latanoprost ophthalmic solution|Latanoprost ophthalmic solution q.d., evening
16058297|NCT02466386|Drug|SPD489|Participants will receive 5 mg of SPD489 capsule orally once daily in the morning and titrated in a step-wise fashion up to either 10 mg, 15 mg, 20 mg, or 30 mg until an optimal dose was reached.
16058298|NCT02466373|Drug|Clonidine (Catapresan®) 0,150 mg/ml, ampoule 1 ml|clonidine intravenous
16058299|NCT02466360|Behavioral|Back Belief questionnaire|
16058300|NCT02466360|Behavioral|QUEBEC scale|
16058301|NCT02466360|Behavioral|Fear Avoidance beliefs questionnaire|
16058302|NCT02466360|Behavioral|Visual analog scale|
16058303|NCT02466360|Behavioral|individual interviews|
16058304|NCT02466360|Behavioral|Focus groups|
16058305|NCT02466347|Drug|Fluticasone propionate|Inhaled corticosteroid, pMDI
16058306|NCT02466347|Drug|Salmeterol (as xinafoate)|Long Acting Beta-agonist (LABA), pMDI
16058307|NCT02466334|Drug|Calcitonin-Gene Related Peptide|1,5 µg/min of IV CGRP over 20 mins
16058308|NCT02466334|Drug|Placebo|40 ml of normal saline over 20 mins
16058309|NCT02466321|Procedure|Inverse/Reverse Shoulder Arthroplasty|Implantation of the Anatomical Shoulder Inverse/Reverse System
16058310|NCT02466308|Device|SAM Ultrasound Diathermy Device|
16058311|NCT02466295|Other|Volume-controlled ventilation|I-gel will be inserted into the patient's mouth. After confirmation of adequate ventilation with the i-gel, the patient's lungs will be mechanically ventilated using the volume-controlled mode with tidal volume 8 ml/kg during surgery.
16058312|NCT02466295|Other|Pressure-controlled ventilation|I-gel will be inserted into the patient's mouth. After confirmation of adequate ventilation with the i-gel, the patient's lungs will be mechanically ventilated using the pressure-controlled mode with tidal volume 8 ml/kg during surgery.
16058379|NCT02465827|Drug|nerve block with saline|Ultrasound guided nerve blocks of the saphenous and obturator nerve, posterior branch with saline for both nerve branches
16058380|NCT02465814|Drug|Vilaprisan (BAY1002670)|Vilaprisan 2 mg (12 weeks), Vilaprisan 2 mg (12 weeks)
16058314|NCT02466282|Device|optical coherence tomography-guided PCI with bioresorbable vascular scaffold|Everolimus-eluting bioresorbable vascular scaffold (Absorb, Abbott Vascular, Santa Clara, CA, USA) was made from a bioabsorbable polylactic acid backbone which is coated with a more rapidly absorbed polylactic acid layer that contains and controls the release of the antiproliferative drug, everolimus. For optimized PCI, both conventional coronary angiography and optical coherence tomography can be used before and after stent implantation. OCT study should be checked at the final post-procedure and stent implantation is optimized.
16058315|NCT02466269|Procedure|The supratemporalis approach|The supratemporalis approach was applied in treatment of diacapitular condylar fractures
16058316|NCT02466256|Procedure|Intraocular lens implantation|Intraocular lens implantation
16058317|NCT02466256|Device|Autosert Injector|Motorised injection device for intraocular lens implantation
16058318|NCT02466256|Device|Royale Injector|Manual, plunger type injection device for intraocular lens implantation
16058319|NCT02466256|Device|Monarch III Injector|Manual, screw type injection device for intraocular lens implantation
16058320|NCT02466243|Drug|JBT-101|"Part A: 20 mg once daily on Days 1-28, then 20 mg twice daily on Days 29-84.
~Part B: JBT-101 20 mg twice daily on Days 1 - 365 of the OLE."
16058321|NCT02466243|Drug|Placebo|"Part A: Once daily on Days 1-28, then twice daily on Days 29-84.
~Part B: Placebo twice daily on Days 1 - 365 of the OLE."
16058322|NCT02466230|Device|Repetitive transcranial magnetic stimulation|Active repetitive transcranial magnetic stimulation for 25 days (Monday through Friday for 5 consecutive weeks). Active rTMS with the FDA approved Neuronetics TMS system. Each treatment will target the left dorsolateral prefrontal cortex. rTMS will be administered at 10Hz with a duty cycle of 4 seconds on and 26 seconds off for 37.5 min.
16058323|NCT02466217|Other|1: AID groups|Clinical and Biological investigations
16058324|NCT02466217|Other|2: Control groups|Clinical and Biological investigations
16058325|NCT02466204|Drug|corifollitropin alfa|Drug is injected subcutaneously. Seven days after, 300 IU FSH daily injected subcutaneously, until at least two leading ovarian follicles reach 17mm in diameter.
16058326|NCT02466204|Drug|Follitropin Beta|Drug is injected subcutaneously, daily, until at least two leading ovarian follicles reach 17mm in diameter.
16058327|NCT02466191|Drug|Memantine|
16058328|NCT02466191|Drug|Gabapentin|
16058329|NCT02466178|Device|Serene RF System|The Serene RF System provides percutaneous delivery of radiofrequency (RF) energy to a targeted nerve.
16058330|NCT02466165|Behavioral|Physical exercise|
16058331|NCT02466152|Drug|GSK2894512 Topical Cream|GSK2894512 will be supplied as white to off-white topical cream in doses of 2.0% (20 milligrams/gram [mg/g]) and 1.0% (10 mg/g)
16058332|NCT02466126|Behavioral|bCBT|"The bCBT intervention uses 6 active-treatment sessions, each lasting 30 to 40 minutes, and telephone booster sessions to solidify changes. All participants receive an initial (core) session. In this session, participants work with their study clinician to set goals that are not restricted to emotional health (e.g., depression) but may also address physical health concerns (e.g., diet, exercise, managing a chronic condition). Following the core session, clinicians provide participants with a series of module choices, from which they select skills that match their most pressing needs. Each module focuses on a CBT technique (e.g., behavioral activation, changing thoughts), introduced and customized to the patient's immediate goals, regardless of the focus (physical or mental health)."
16058333|NCT02466113|Other|A 6 microRNA stratified tool|Investigators randomly assign patients to be assessed by a 6 microRNA stratified tool. MicroRNA(miRNA) tool contains miRNA of miR-21、miR-20a-5p、miR-103a-3p、miR-106b-5p、miR-143-5p and miR-215. Investigators evaluate these miRNA status of surgical specimens using qRT-PCR and calculate their risk score(risk score =(0.108×status of miRNA-21-5p)+(0.086×status of miRNA-20a-5p)+(0.240×status of miRNA-103a-3p)+(0.095×status of miRNA-106b-5p)-(0.238×status of miRNA-143-5p)-(0.237×status of miRNA-215),low expression status equals 0 and high expression status equals 1). Investigators defined high risk patient if their score larger than 1, the others as low risk patient.The high risk group should receive adjuvant chemotherapy while the low risk group deserve observation.
16058334|NCT02466113|Other|A classic stratified tool|Investigators randomly assign patients to be assessed by by classical pathological features. Pathological features include poorly differentiated histology(exclusive of those cancers that are MSI-H),lymphatic/vascular invasion,bowel obstruction and <12 lymph nodes examined. Investigators defined high risk patient if they had any pathological features, the others as low risk patient. The high risk group should receive adjuvant chemotherapy while the low risk group deserve observation.
16058335|NCT02466100|Behavioral|goals of care|. Patients in the GoC intervention group, telephone coaching by a research nurse to help patients role-play talking with their HF providers. Both patients and their providers, will be provided with summaries of individualized, patient-centered information about patient preferences for communicating about end-of-life care and patient self-identified barriers to and facilitators of communication about end-of-life care with tips on how to initiate goals of care discussions. Providers of patients in the intervention group will also be provided with patient-specific prognostic information based on the Seattle Heart Failure Model.
16058336|NCT02466087|Drug|Mg Cl|Four supplements a day for 6 weeks.
16058337|NCT02466074|Drug|Acetazolamide|see arm description
16058338|NCT02466074|Drug|Placebo|Placebo arm
16058339|NCT02466061|Behavioral|Telemedicine Weight Management plus Wi-Fi Scale (Arm A)|Telephonic weight loss counseling by trained interventionists, with guided digital scale measurements of weight, lean mass, and fat mass. Counseling sessions and digital weight recording occur at regularly scheduled intervals over a six-month intervention period.
16058340|NCT02466061|Behavioral|Text for Diet (Text4Diet) Group (Arm B)|Short Message Service (SMS) text messaging in which participants receive 3-5 text messages each day during a six-month intervention period. The text messages provide tips and reminders to encourage healthy eating and weight loss. Participants on this arm also receive a digital scale to track and report weight as prompted once per week through the text program.
16058341|NCT02466061|Behavioral|Enhanced Usual Care Group (Arm C)|Participants are provided with handouts based on American Cancer Society guidelines for healthy eating and exercise.
16058381|NCT02465814|Drug|Vilaprisan (BAY1002670|Placebo (12 weeks),Vilaprisan (12 weeks)
16058382|NCT02465814|Drug|Vilaprisan (BAY1002670|Vilaprisan 2 mg (12 weeks), treatment break, Vilaprisan 2 mg (12 weeks)
16058383|NCT02465814|Drug|Vilaprisan (BAY1002670)|Placebo (12 weeks), treatment break, Vilaprisan 2 mg (12 weeks)
16058342|NCT02466048|Procedure|Spinal Fusion|Spinal fusion, also known as spondylodesis or spondylosyndesis, is a surgical technique used to join two or more vertebrae. Supplementary bone tissue, from the patient (autograft), is used in conjunction with the body's natural bone growth (osteoblastic) processes to fuse the vertebrae. Either the right or left side of one patient will be selected for the study group, and the other, for the control group, through randomization. In the study group site, SurgiFill™ and the autogenous bone mixture shall be transplanted, whereas in the control group site, only the autogenous bone shall be transplanted. The autogenous bones are from iliac part.
16058343|NCT02466048|Device|SurgiFill™|SurgiFill™ is a gel-type high-purity ateolcollagen for bone grafting. SurgiFill™ is used with autogenous iliac graft for dorsolateral spinal fusion.
16058344|NCT02466035|Dietary Supplement|Extensively hydrolyzed casein formula plus Lactobacillus rhamnosus GG|Extensively hydrolyzed casein formula containing the probiotic Lactobacillus rhamnosus GG
16058345|NCT02466022|Drug|Dexmedetomidine|Bolus dose prior to spinal anesthetic
16058346|NCT02466022|Drug|Bupivicaine|Intrathecal hyperbaric bupivicaine 12.75mg
16058347|NCT02466022|Drug|Normal Saline|Bolus 0.1cc/kg Normal Saline over 10 min
16058348|NCT02466022|Drug|Fentanyl|Intrathecal Fentanyl 10ug
16058349|NCT02466022|Drug|Midazolam|0-4mg of IV Midazolam prn for rescue sedation
16058350|NCT02466009|Drug|Regorafenib|Regorafenib 120 mg (3 tablets) each day for 21 days of a 28 day cycle with the possibility of an increase in the dose to 160 mg (4 tablets).
16058351|NCT02465996|Device|pCLE examination|All FD patients received pCLE examination.
16058352|NCT02465996|Drug|Puyuanhewei|FD patients willing to receive Puyuanhewei were given 4 pills three times a day regardless of PDS or EPS for 4 weeks after pCLE examination.
16058353|NCT02465983|Biological|CART-meso-19 T cells|A single dose of CART-meso-19 cells (combination therapy with CART-meso and CART19 cells) will be administered intravenously as two separate infusions. The dose is 1-3x107/m2 (Cohort 1) or 1-3x108/m2 (Cohort 2) CART positive cells. The infusion will be scheduled to occur 3 (±1) days after a single dose of 1.5 grams/m2 of cyclophosphamide, which will be administered according to standard procedures in the outpatient setting. Patients will receive CART cell treatment on an outpatient basis.
16058354|NCT02465983|Drug|Cyclophosphamide|A single dose of chemotherapy to be administered prior to dosing of the CART-meso-19 cells
16058355|NCT02465970|Device|STARSTIM|"Multifocal transcranial direct current stimulation.
~CE-marked device, comprising a cap with 2 to 8 electrodes, connected with a programmable mobile stimulator.
~The stimulation is applied during a 60 min session"
16058356|NCT02465970|Device|sham TDCS|
16058357|NCT02465957|Biological|aNK (NK-92)|A natural killer cell line recovered from a patient with large granular lymphoma
16058358|NCT02465944|Drug|FFP104|Three intravenous infusions of FFP104 over 15 days (d0, d7 and d14)
16058359|NCT02465944|Drug|Placebo|Three intravenous infusions of 0.9% Saline over 15 days (d0, d7 and d14)
16058360|NCT02465931|Other|Paper and Pencil Informed Consent|Paper-based informed consent form will be sent to participant and family before data collection visit. They will be able to review as many times as they wish before visit. During visits, simplified overview of informed consent form will be provided in person just once. For MacArthur Competence Assessment Tool (MacCAT) Questions, All questions will be asked after the disclosure information has been presented. Questions will have the same wording as experimental condition. Procedures will mimic MacCAT/flipchart (incorrect or partial credit will be given opportunity to answer question again after disclosure information is repeated). There will be multiple choice options rather than open-ended. Finally, data collection will be done through paper and pencil.
16058361|NCT02465931|Other|Digital Informed Consent Tool|Paper informed consent form will be sent to participant and family before data collection visit. They will be able to review as many times as they wish before visit. During visits, the participant can go through the tablet-based tool up to 3 times. All questions will be embedded within the vignettes/presentation of disclosure information. Question will use simplified wording, similar to flipchart. Procedures will mimic MacArthur Competence Assessment Tool (MacCAT) /flipchart (incorrect or partial credit will be given opportunity to answer question again after disclosure information is repeated). Multiple choice options will be utilized rather than open-ended. Finally, response data stored within tool and exported to dataset for analysis.
16058362|NCT02465918|Device|motor cortex stimulation (Change of Stimulation Timing)|
16058363|NCT02465905|Other|raw milk|
16058364|NCT02465905|Other|Heated milk|
16058365|NCT02465892|Behavioral|Pillars4Life|The Pillars4Life program will guide participants through activities that will help to identify stress and anxiety triggers, plan ways to cope with the stress of life and cancer, manage anxiety, deal with chronic pain, and balance competing priorities in life.
16058366|NCT02465879|Other|Therapist Triage|An extended role occupational or physical therapist will triage each subject in the study to determine the urgency of their case and how soon they need to see the rheumatologist.
16058367|NCT02465866|Drug|CL-108|Hydrocodone bitartrate/acetaminophen/promethazine 7.5 mg/325 mg/12.5 mg single dose by mouth
16058368|NCT02465866|Drug|Vicoprofen|Hydrocodone Bitartrate and Ibuprofen 7.5 mg/200 mg single dose tablet by mouth
16058369|NCT02465866|Drug|Ultracet|Tramadol HCl/acetaminophen 37.5 mg/325 mg single dose tablet by mouth
16058370|NCT02465866|Drug|Phenergan|Phenergan (Promethazine HCl, USP) 12.5 mg single dose tablet by mouth
16058371|NCT02465853|Drug|Hyaluronic Acid|Injection Hyaluronic Acid in the experimental group
16058372|NCT02465853|Drug|Physiological saline solution|Injection 0.9% Physiological saline solution<1.0 ml
16058373|NCT02465853|Other|physical therapy and occupational therapy|rehabilitation
16058374|NCT02465840|Procedure|custom-made dynamic hand splint|custom-made dynamic splinting with more early active exercises intervention.
16058375|NCT02465840|Procedure|custom-made protective hand splint|Immobilization splint with gentle ROM exercises
16058376|NCT02465840|Other|physical therapy and occupational therapy|both the immobilization and Kleinert programs including physical therapy and occupational therapy for 2-3 times per week.
16058377|NCT02465827|Drug|nerve block with ropivacaine|Ultrasound guided nerve blocks of the saphenous and obturator nerve, posterior branch with ropivacaine 0.75% for both nerve branches
16058378|NCT02465827|Drug|nerve block with ropivacaine and with saline|nerve blocks of the saphenous nerve with ropivacaine 0.75% and obturator nerve, posterior branch with saline
16058388|NCT02465801|Drug|HSA-GCSF 1.5 mg|Human Serum Albumin GCSF 1.5 mg at day 3 and Day 7
16058389|NCT02465801|Drug|GCSF|GCSF 5 mcg/kg/day
16058390|NCT02465788|Device|GentleTouch|Four distinct areas on each selected anatomical area will be treated with different treatment parameters.
16058391|NCT02465775|Device|UltraShape treatment|Fat cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time.
16058392|NCT02465762|Device|ultrashape Fat reduction|Ultrashape Device focused ultrasound to produce localized mechanical motion within fat tissues and cells for the purpose of producing mechanical cellular membrane disruption. It is intended for reduction in abdominal circumference.
16058393|NCT02465749|Drug|Continuous oxygen|Continuous oxygen intake at a concentration of 93±3%, 3L/min flow-rate, 2h/bid, five days a week;
16058394|NCT02465749|Device|blue light-absorbing sunglasses|Wearing blue light-absorbing sunglasses at daily time;
16058395|NCT02465749|Drug|Compound thrombosis capsule sig: 1.5g/tid|Compound thrombosis capsule sig: 1.5g/tid
16058396|NCT02465749|Drug|Ginkgo biloba pills sig: 300mg/tid;|Ginkgo biloba pills sig: 300mg/tid;
16058397|NCT02465749|Drug|Vitamin B sig: 10mg/tid|Vitamin B sig: 10mg/tid
16058398|NCT02465749|Drug|Vitamin AD sig: 1 tablet/tid|Vitamin AD sig: 1 tablet/tid
16058399|NCT02465736|Drug|Docetaxel|25mg/ m2 Docetaxel dose administered on days 1, 8, 15, and 22.
16058400|NCT02465736|Drug|Cisplatin|25mg/ m2 on days 1, 8, 15 and 22.
16058401|NCT02465736|Radiation|Radiation|Patient will receive 4 weeks of radiation therapy (44 Gy/20 fractions).
16058402|NCT02465736|Procedure|Surgery|McKeown esophagectomy, Ivor Lewis esophagectomy or minimally invasive esophagectomy will be performed 4-8 weeks after chemoradiotherapy. Two-field lymphadenectomy with total mediastinal lymph node dissection is performed during surgery.
16058403|NCT02465736|Drug|Vinorelbine|25mg/ m2 on days 1, 8 of each cycle (i.e. every 21 days).
16058404|NCT02465736|Drug|Cisplatin|75mg/ m2 on day 1 of each cycle only (i.e. every 21 days).
16058405|NCT02465723|Device|MRI with IVIM DW-MRI|
16058406|NCT02465723|Other|Blood draw|For each patient enrolled, 8-10 mL of whole blood will be collected into glass, anti-coagulant-free tubes and allowed to clot 20-30 minutes.
16058407|NCT02465710|Procedure|Pelvic organ prolapse surgery without mesh|retrospective study
16058408|NCT02465710|Procedure|Pelvic organ prolapse surgery with mesh|
16058409|NCT02465697|Behavioral|Reappraisal Training|
16058410|NCT02465684|Procedure|unicondylar knee arthroplasty|
16058411|NCT02465658|Other|Medical records were reviewed.|retrospective study
16058412|NCT02465645|Drug|Carvedilol|
16058413|NCT02465645|Drug|Carvedilol + Simvastatin|
16058414|NCT02465632|Drug|Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel|
16058415|NCT02465632|Drug|BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%|
16058416|NCT02465632|Drug|Placebo|
16058417|NCT02465606|Drug|Lebrikizumab|Lebrikizumab Dose Level 1 subcutaneous monotherapy was administered SC once every 4 weeks for a total of 3 doses.
16058418|NCT02465606|Drug|Topical Corticosteroid Creams (Triamcinolone acetonide 0.1% and Hydrocortisone 2.5%)|Triamcinolone acetonide 0.1% cream will be supplied as single 454-g jars to be used on the body. Hydrocortisone 2.5% cream will be supplied as single 28-g tubes to be used on the face and intertriginous areas as indicated.
16058419|NCT02465593|Drug|PEP503|The volume of PEP503 to be administered is based on the baseline tumor volume of each patient. There will be 4 dose levels in Phase Ib.
16058420|NCT02465593|Drug|5-fluorouracil|225 mg/m2 a day, 5 days/week for 5 weeks during radiotherapy period
16058421|NCT02465593|Drug|capecitabine|825 mg/m2 BID 5 days/week for 5 weeks during the radiotherapy period
16058422|NCT02465593|Procedure|surgical resection|Approximately 8 weeks after the completion of chemoradiotherapy, surgical resection of the tumor (total mesorectal excision, TME) will be performed once the tumor become resectable.
16058423|NCT02465593|Radiation|Radiotherapy|Intensity-modulated radiation therapy (IMRT) or intensity modulated arc therapy (IMAT) of 5,000 cGy in 25 fractions (200 cGy/fraction, 5 times/week) to gross tumor and involved nodes and 4,500 cGy in 25 fractions (180 cGy/fraction, 5 times/week) to pelvis, starting at 24 hours after PEP503 injection.
16058424|NCT02465580|Drug|hrIL-2 active|active group: placebo group =1:1
16058425|NCT02465580|Drug|hrIL-2 placebo|active group: placebo group =1:1
16058426|NCT02465567|Drug|BGF MDI 320/14.4/9.6 μg|Budensonide, Glycopyrronium, and Formoterol Fumarate
16058427|NCT02465567|Drug|GFF MDI 14.4/9.6 μg|Glycopyrronium, and Formoterol Fumarate
16058428|NCT02465567|Drug|BGF MDI 160/14.4/9.6 μg|Budensonide, Glycopyrronium, and Formoterol Fumarate
16058429|NCT02465567|Drug|BFF MDI 320/9.6 μg|Budensonide, and Formoterol Fumarate
16058430|NCT02465554|Procedure|Myocardial contrast echocardiography|Myocardial contrast echocardiography will be performed to further stratify risk as described in the cohort section.
16058431|NCT02465541|Procedure|Gentle yoga therapy|Mindfulness in Motion is a mindfulness based intervention that is an 8-10 week program for adults interested in learning a practical strategy for stress reduction, intended to be delivered on the worksite or home.
16058432|NCT02465541|Other|counseling intervention|Undergo dietary counseling that will include 10 (20-min) nutritional counseling sessions with a registered dietitian.
16058433|NCT02465541|Other|educational intervention|Undergo enhanced usual care
16058434|NCT02465541|Other|quality-of-life assessment|Ancillary studies
16058435|NCT02465541|Other|questionnaire administration|Ancillary studies
16058436|NCT02465528|Drug|Ceritinib (LDK378)|Ceritinib was to be administered orally once daily at a dose of 750 mg (5 capsules of 150 mg) on a continuous dosing schedule. A complete treatment cycle was defined as 28 days of once daily continuous treatment with ceritinib.
16058437|NCT02465515|Biological|Albiglutide 30 mg|Once weekly subcutaneous injection. Starting dose 30 mg may be increased to 50 mg if needed.
16058438|NCT02465515|Biological|Albiglutide 50 mg|Once weekly subcutaneous injection. Starting dose 30 mg may be increased to 50 mg if needed.
16058439|NCT02465515|Biological|Albiglutide matching placebo|Once weekly subcutaneous injection. Matched to 30 mg and 50 mg albiglutide.
16058440|NCT02465502|Drug|Regorafenib (Stivarga, BAY73-4506)|Regorafenib 160 mg orally once a day for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off).
16058441|NCT02465489|Drug|Deferiprone extended release|Deferiprone 1000 mg extended release tablet formulation
16058442|NCT02465489|Drug|Deferiprone immediate release|Ferriprox (deferiprone) 500 mg immediate release tablet formulation
16058443|NCT02465476|Procedure|telemedicine|treatment pathway organized by telemedicine
16058444|NCT02465463|Procedure|Fecal microbiota transplant (FMT)|250 mL of donor stool will be infused into the colon by flexible sigmoidoscopy
16058445|NCT02465463|Device|flexible sigmoidoscopy|
16058446|NCT02465450|Drug|JBT-101 (lenabasum)|Subjects will receive JBT-101 1 mg qd or JBT-101 5 mg qd on Days 1-28. Subjects will receive either JBT-101 20 mg q am (with placebo q pm) or JBT-101 20 mg twice a day on Days 29-84.
16058447|NCT02465450|Other|Placebo|Subjects will receive placebo once a day on Days 1-28, placebo q pm on Days 29-84 (with JBT-101 20 mg q am), or placebo bid on Days 29-84.
16058448|NCT02465437|Drug|JBT-101|JBT-101 5 mg q am, 20 mg q am, or 20 mg bid on Days 1-28. JBT-101 20 mg bid on Days 29-84.
16058449|NCT02465437|Drug|Placebo|Placebo q pm (with JBT-101 5 or 20 mg q AM) or placebo bid on Days 1-28. Placebo bid on Days 29-84.
16058450|NCT02465437|Drug|Part B Open-Label Extension|JBT-101 20mg bid on Days 1-364
16058451|NCT02465424|Other|quality of life questionnaires|Randomised allocation of 4 validated quality of life questionnaires followed by study specific overview questionnaire
16058452|NCT02465411|Device|Dexcom G4 or later generation|Continuous glucose monitoring with DexCom G4 platina or later generations
16058453|NCT02465398|Procedure|Fracture Shoulder Arthroplasty|Implantation of the Anatomical Shoulder Fracture System
16058454|NCT02465385|Drug|Linaclotide|Every participant with be given 290 mcg of linaclotide 1 hour prior to receiving their capsule, in place of the standard (golytely) preparation
16058455|NCT02465372|Behavioral|CSPAP|Comprehensive School Physical Activity Program.
16058456|NCT02465359|Drug|Immune Globulin Subcutaneous (Human)|Patients who have CIDP and are on IVIG will be allowed in the study to try subcutaneous immune Globulin (SCIG) as part of an open label study.
16058457|NCT02465346|Device|MSU-based stroke management|Prehospital stroke treatment with a mobile stroke unit
16058458|NCT02465346|Device|Control stroke management|Conventional stroke management
16058459|NCT02465333|Procedure|Heel Fat Grafting|"Fat grafting is widely used by plastic surgeons and is considered a standard of care procedure in plastic surgery. Fat tissue to be used for grafting is harvested with a small liposuction cannula. The fat is then centrifuged, cleaned, and loaded into 1cc syringes and injected into the heel fat pad using specialized cannulas.
~Postoperatively, the foot will be bandaged for twenty-four hours and the subject will be advised to limit ambulation. Over the next three weeks, the patient will be instructed to wear a cushioned, supportive sneaker and participate in only activities of normal daily living, with no excessive aerobic activity."
16058460|NCT02465333|Drug|Local anesthetic|"To numb the foot for the fat grafting procedure, lidocaine with epinephrine will be used. This will be injected near the posterior tibial nerve to numb the bottom of the foot.
~Local anesthetic of lidocaine with epinephrine will also be used to numb the fat graft harvest site (i.e. abdomen or thigh). This will allow a small incision to make so that tumescent solution can be injected into the area of fat graft harvest. Tumescent solution is a combination of injectible saline, epinephrine and lidocaine that causes numbness and vasoconstriction in the area where the fat will be harvested. This limits pain and bruising during the procedures. Only a very small amount of tumescent should be needed (i.e. <200ml). Only a few cc's of fat are needed for injection into the foot."
16058461|NCT02465320|Drug|COL-1077|single dose of 150mg lidocaine (10%w/w) administered by intravaginal insertion
16058462|NCT02465320|Drug|Placebo|single dose of bioadhesive gel administered by intravaginal insertion
16058463|NCT02465307|Behavioral|Confusion Assessment Method|Confusion Assessment Method (CAM) score
16058464|NCT02465307|Device|Accelerometer|3 accelerometers (placed on upper arm, wrist and ankle) and 1 placed on wall as ambient light sensor
16058465|NCT02465307|Device|Commercially available camera|As part of facial recognition video system
16058466|NCT02465307|Device|Internet Pod (iPod)|Monitors noise levels in the room
16058467|NCT02465307|Diagnostic Test|Cortisol Swab|Cortisol level collected through self administered salivary swab
16058468|NCT02465294|Dietary Supplement|Probiotic|This group will receive the Lactobacillus probiotic, which will be taken as a capsule once daily for 12 weeks.
16058469|NCT02465294|Behavioral|Behavioral lifestyle intervention|All participants will participate in weekly group meetings of 15 to 20 participants for a facilitated discussion of specific nutritional, behavioral, and physical activity topics chosen to promote weight loss.
16058470|NCT02465294|Other|Placebo|This group will receive the placebo and will be taken as a capsule once daily for 12 weeks. The placebo will contain encapsulated potato starch which is used the matrix in the probiotic supplements.
16058471|NCT02465294|Other|Blood Test|All subjects will have blood tests performed.
16058472|NCT02465294|Dietary Supplement|Probiotic|This group will receive the blend of Bifidobacterium and Lactobacillus probiotic, which will be taken as a capsule once daily for 12 weeks.
16058473|NCT02465281|Other|Device: 3T scanner with MRI-compatible robot|
16058474|NCT02465268|Biological|pp65-shLAMP DC with GM-CSF|
16058475|NCT02465268|Biological|unpulsed PBMC and saline|
16058476|NCT02465268|Drug|Td|All subjects will receive a Td booster before study drug dose #1. Subjects in the experimental arms will receive Td skin prep before study drug doses #3, #6, and #9.
16058477|NCT02465268|Drug|Saline|
16058478|NCT02465268|Biological|pp65-flLAMP DC with GM-CSF|
16058479|NCT02465255|Drug|Ketorolac|
16058480|NCT02465255|Drug|Tramadol|
16058481|NCT02465255|Drug|Acetaminophen|
16058482|NCT02465229|Procedure|Multimodal tissue-sampling methods before and after stricture dilation|Each participant will receive the following tissue-sampling methods in order : 1)intraductal suction, 2)intraductal forceps biopsy, 3)brushing cytology, 4)stricture dilation, 5)intraductal suction, 6)intraductal forceps biopsy and 7)brushing cytology during endoscopic retrograde cholangiopancreatography.
16058483|NCT02465216|Other|Placebo|Placebo
16058484|NCT02465216|Biological|ID93 + GLA-SE|ID93 + GLA-SE
16058485|NCT02465203|Drug|Previous treatment in DEB025 study|Follow-up after DEB025 active study
16058486|NCT02465164|Device|Cook catheter|
16058487|NCT02465164|Drug|Oxytocin|
16058494|NCT02465099|Device|Ultrasonic Dissection (UD)|Ultrasonic energy will be used as the primary means for soft tissue dissection in patients diagnosed with adolescent scoliosis undergoing multilevel (>=6) PSF
16058495|NCT02465099|Device|Electrocautery Dissection (ED)|Electrocautery dissection will be used as the primary means for soft tissue dissection in patients diagnosed with adolescent scoliosis undergoing multilevel (>=6) PSF
16058496|NCT02465086|Other|Training of linguistic recursion|Training of recursion comprehension will include cooperative dialogue and feedback on the sentences and small dialogues. The training conditions will be further divided into marking the change of the truth-value.
16058497|NCT02465073|Device|NXTSC wound gel|Subjects will receive NXTSC wound gel only.
16058498|NCT02465073|Device|NXTSC wound gel plus Standard of Care|Subjects will be randomized to the NXTSC wound gel plus Standard of Care of only.
16058499|NCT02465073|Device|Standard of Care Group|Subjects will receive Standard of Care only.
16058534|NCT02465047|Other|Self-help booklet|See Arm/Group Description
16058535|NCT02465034|Device|Transcranial Magnetic Stimulation|Transcranial Magnetic Stimulation (TMS) will be performed using the Magstim BiStim^2 paired pulse stimulator to measure transient cortical excitability. Single pulse transcranial magnetic stimulation applied at low frequencies (not greater than 0.25 Hz) will be used. The may be repeated at multiple study visits. All five study visits will be completed within four weeks of the initial visit.
16058536|NCT02465034|Device|Traditional Paired Associative Stimulation|Paired associative stimulation (PAS) is a combination of transcranial magnetic stimulation (TMS) and electrical stimulation of the median nerve. 180 paired stimuli are delivered at 0.25Hz for 12 minutes. Median nerve stimuli at 300% of the perceptual threshold will be applied 25ms prior to transcranial magnetic stimulation delivery over the ipsilesional (stroke) or non-dominant (control) cortex. Transcranial Magnetic Stimulation (TMS) will be performed using the Magstim BiStim^2 paired pulse stimulator unit and a bipolar bar electrode will be used for median nerve stimulation. This traditional paired associative stimulation may be repeated at multiple study visits. All five study visits will be completed within four weeks of the initial visit.
16058537|NCT02465034|Device|Median Nerve Stimulation|Stimulation of the median nerve will be performed using a bipolar bar electrode affixed to palmar aspect of the forearm proximal to the crease of the wrist bilaterally. Stimuli will be delivered 23ms prior to the transcranial magnetic stimulation (TMS) pulse with 0.1ms rectangular pulses at an intensity to evoke a 1mV response in the abductor pollicis brevis (APB) muscle. This may may be repeated at multiple study visits. All five study visits will be completed within four weeks of the initial visit.
16058538|NCT02465034|Device|Corticocortical Paired Associative Stimulation|Corticocortical Paired associative stimulation (ccPAS) is a combination of transcranial magnetic stimulation (TMS) and electrical stimulation of the median nerve. 180 paired stimuli are delivered at 0.25Hz for 12 minutes. The interstimulus interval will range from 5-15ms depending on site of stimulation.Transcranial Magnetic Stimulation (TMS) will be performed using the Magstim BiStim^2 paired pulse stimulator unit and a bipolar bar electrode will be used for median nerve stimulation. This corticocortical paired associative stimulation may be repeated at multiple study visits. All five study visits will be completed within four weeks of the initial visit.
16058539|NCT02465034|Device|Sham Paired Associative Stimulation|The sham paired associative stimulation (PAS) is a combination of transcranial magnetic stimulation (TMS) and electrical stimulation of the median nerve. The coil is rotated and separated from the head with a plastic spacer to ensure indirect contact with the head.180 paired stimuli are delivered at 0.25Hz for 12 minutes. Transcranial Magnetic Stimulation (TMS) will be performed using the Magstim BiStim^2 paired pulse stimulator unit and a bipolar bar electrode will be used for median nerve stimulation. This sham paired associative stimulation may be repeated at multiple study visits. All five study visits will be completed within four weeks of the initial visit.
16058540|NCT02465021|Other|Dietary intervention|All arms are given to all participants, in a randomized order
16058541|NCT02465008|Drug|Levobupivacaine|
16058542|NCT02465008|Drug|Placebo|
16058543|NCT02464995|Device|Bronchial thermoplasty with the Alair System|
16058544|NCT02464982|Procedure|Tattoo|tattoo device with EC standards, and sterile single-use only needle
16058547|NCT02464943|Device|Endovascular Treatment (Zenith)|Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
16058548|NCT02464917|Device|Device: simple facemask to administer supplemental oxygen|
16058549|NCT02464904|Device|Cryotherapy|Subjects will have their blood drawn prior to undergoing a staging pleuroscopy. During the pleuroscopy pleural fluid will be collected as well as pleural biopsies (4 to 8 research biopsies). The procedure will involve 2 to 3 applications of cryospray on the location of the disease. After establishing cryofrost over a minimum of a 2 x 2 cm area, cryospray will continue for 15 to 20 seconds, allow a thaw period of 60 seconds followed by one to two repeats in the same location before proceeding onto the next location. We will treat a minimum of 6 x 6 cm area in aggregate. The freezing procedure will be video-recorded and freezing locations and time will be recorded. Approximately, 14 days following the staging pleuroscopy patients will undergo surgical treatment as per standard of care, with repeat blood, pleural fluid and tissue collection.
16058550|NCT02464904|Other|Control|Subjects will have their blood drawn prior to undergoing a staging pleuroscopy. During the pleuroscopy pleural fluid will be collected as well as pleural biopsies (4 to 8 research biopsies). Approximately, 14 days following the staging pleuroscopy patients will undergo surgical treatment as per standard of care, with repeat blood, pleural fluid and tissue collection
16058551|NCT02464891|Drug|CCX168|
16058552|NCT02464878|Drug|Alpha 1-Antitrypsin|Patients will receive three times a week AAT infusions in the peri-transplant period for three weeks.
16058553|NCT02464878|Procedure|Islet Transplantation|
16058554|NCT02464878|Drug|Thymoglobulin|Patients will receive a total of 5 doses between Day -2 and Day +2
16058555|NCT02464878|Drug|Basiliximab|Basiliximab will be used for subsequent transplants.
16058556|NCT02464878|Drug|Etanercept|Etanercept will be given on the day of transplant and on Days 3, 7, and 10 post-transplant.
16058557|NCT02464865|Drug|Thiamine 1|"If severe symptoms and signs of thiamine deficiency are present, thiamine is prescribed.
~Intervention 1 : severe symptom (heart failure, convulsion, or coma) : 50 mg thiamin administered very slowly intravenously, followed by a daily intramuscular dose of 10 mg for a week, and finally followed by 3-5 mg of thiamine per day orally for at least 6 weeks"
16058558|NCT02464865|Other|Non-thiamine|no symptoms and signs of thiamine deficiency
16058559|NCT02464865|Drug|Thiamine 2|"If symptoms and signs of thiamine deficiency are present, thiamine is prescribed.
~If mild symptom : a daily oral dose of 10 mg thiamin during the first week, followed by 3-5 mg of thiamin per day orally for at least 6 weeks"
16058560|NCT02464852|Behavioral|Head movements|Participants will be asked to perform a series of movements of exploration of their maximum neck range of motion, including: flexion, extension, right and left lateral flexion, right and left axial rotation.
16058561|NCT02464852|Behavioral|Activities of daily living (drinking, washing hand and eating)|Patients will be asked to perform a series of activities of daily living (drinking, eating and washing hands).
16058562|NCT02464852|Device|Sheffield Support Snood|
16058563|NCT02464852|Device|sEMG|
16058564|NCT02464826|Drug|Nailprotex|Nailprotex apply to the abnormal nail twice daily
16058565|NCT02464813|Drug|Pregabalin|Patients will receive pregabalin twice preoperatively and twice daily for 5 days after surgery.
16058566|NCT02464813|Drug|Sugar pill|Patients will receive placebo twice preoperatively and twice daily for 5 days after surgery.
16058567|NCT02464813|Drug|Oxycodone|All patients will receive oxycodone as analgetic treatment administered by PCA. Oxycodone consumption will be measured.
16058568|NCT02464800|Procedure|Vitrectomy for proliferative diabetic retinopathy|25-gauge vitrectomy
16058569|NCT02464787|Dietary Supplement|LifePak Nano|Two twin-sachet packets of seven (7) supplements twice per day, for the entire eight-week experimental period.
16058570|NCT02464774|Procedure|Breast-Conserving Therapy|Patients undergo lumpectomy with surgical axillary staging with all lesions resected to negative margins.
16058571|NCT02464774|Procedure|Mastectomy|Patients undergo mastectomy with surgical axillary staging with all lesions resected to negative margins.
16058572|NCT02464774|Drug|Adjuvant Chemotherapy|Patients with stage I and II receive adjuvant chemotherapy using TC and TAC regimen respectively.
16058573|NCT02464774|Radiation|Radiation Therapy|N0: Radiation therapy to whole breast (+boost to tumor bed) or consideration of partial breast irradiation in selected patients; (2) N1: Radiation therapy to whole breast (+boost to tumor bed), infraclavicular region, and supraclavicular area with or without radiation therapy to internal mammary nodes.
16058574|NCT02464761|Drug|Visudyne|
16058575|NCT02464748|Other|TiM telehealth arm|
16058576|NCT02464735|Device|Polysomnography|
16058577|NCT02464722|Drug|Dexmedetomidine|1 mcg/kg iv loading dose of remifentanil over a period of 60 seconds. Later, an infusion was started at the rate of 0.2-0.4mcg/kg/min.
16058578|NCT02464722|Drug|Remifentanil|1 mcg/kg iv loading dose of remifentanil over a period of 10 minutes. Later, an infusion was started at the rate of 0.4-0.8mcg/kg/min.
16058579|NCT02464722|Drug|Epinephrine|Before the start of surgery, 1/100000 epinephrine infiltration was administered to the nasal passages by the surgeon.
16058580|NCT02464722|Drug|Propofol|Anesthesia was induced with propofol 2 mg kg-1
16058581|NCT02464722|Drug|Rocuronium|Anesthesia was induced with rocuronium 0.6 mg kg-1
16058582|NCT02464709|Drug|Aminolevulinic Acid|A 0,25mm-thick layer of BF-200 ALA (aminolevulinic acid, Ameluz®) light sensitizer gel is applied on one randomized treatment side of face.
16058583|NCT02464709|Drug|Methyl 5-aminolevulinate|A 0,25mm-thick layer of MAL (methyl 5-aminolevulinate, Metvix®) light sensitizer cream is applied on one randomized treatment side of face.
16058584|NCT02464696|Drug|Methylprednisolone|IPS cohort only
16058585|NCT02464696|Procedure|Oxygen Therapy|Receive high flow oxygen therapy
16058586|NCT02464696|Device|Positive Air Pressure Device|Undergo NIPPV
16058587|NCT02464683|Dietary Supplement|VitaminD|200 International Units (oral dose) daily of 60 days
16058588|NCT02464670|Biological|INO-4201|INO-4201 delivered IM followed by Electroporation
16058589|NCT02464670|Biological|INO-4202|INO-4202 delivered IM followed by Electroporation
16058590|NCT02464670|Biological|INO-4201|INO-4201 delivered ID followed by Electroporation
16058591|NCT02464670|Biological|INO-4212|INO-4212 delivered IM followed by Electroporation
16058592|NCT02464670|Biological|INO-4212 + INO-9012|INO-4212 + INO-9012 delivered IM followed by Electroporation
16058593|NCT02464670|Biological|INO-4201 + INO-9012|INO-4201 + INO-9012 delivered ID followed by Electroporation
16058594|NCT02464657|Drug|Nivolumab|"Phase I Starting Dose of Nivolumab: 1 mg/kg by vein on Day 24 of a 28 day cycle.
~Phase II Starting Dose of Nivolumab: Maximum tolerated dose from Phase I."
16058595|NCT02464657|Drug|Idarubicin|Phase I and Phase II dose of Idarubicin 12 mg/m2 by vein daily for 3 on Days 1 - 3 of a 28 day cycle.
16058596|NCT02464657|Drug|Cytarabine|Phase I and Phase II dose of Cytarabine (Ara-C) 1.5 g/m2 by vein daily on Days 1 - 4 of a 28 day cycle.
16058597|NCT02464657|Drug|Solu-medrol|Phase I and Phase II dose of Solu-medrol 50 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
16058598|NCT02464657|Drug|Dexamethasone|Phase I and Phase II dose of Dexamethasone 10 mg by vein daily for 3 - 4 days with Ara-C on Days 1 - 4 of a 28 day cycle.
16058599|NCT02464644|Other|Questionnaire|To capture large sufficiently large numbers of individuals for appropriate statistical power (see below), a web based questionnaire design was considered the most appropriate tool. SurveyMonkey was identified as the most suitable means to generate the questionnaire, facilitate confidential answers by the target populations, and for analysis of questionnaire data. The designed survey can also be presented in paper format, and used in our clinical service.
16058600|NCT02464631|Drug|Sofosbuvir + Ribavirin 1|
16058601|NCT02464631|Drug|Sofosbuvir + Ribavirin 2|
16058602|NCT02464631|Drug|Sofosbuvir + Ribavirin 3|
16058603|NCT02464618|Behavioral|Social contact intervention|The social contact of the patients in this arm will be engaged to improve adherence to out-patient endoscopy
16058604|NCT02464605|Biological|SEL-037 (pegsiticase)|Intravenous infusion of SEL-037
16058605|NCT02464592|Procedure|Transbronchial lung biopsy.|Transbronchial lung biopsy with cryoprobe and with conventional forceps.
16058606|NCT02464566|Behavioral|Intensive lifestyle intervention|
16058607|NCT02464566|Other|Health Education|
16058608|NCT02464553|Other|periradicular therapy (PRT)|RTG controlled periradicular therapy (PRT) is a microinvasive interventional pain release procedure. Advantage of targeted pain therapy is exact administration of effective drugs to the nerve root in the area of the thoracic, lumbar or sacral spines.
16058609|NCT02464540|Procedure|Laminate veneers luted with light-cured resin cement|After the use of light-cured luting agent the color of laminate venners will be performed with visual evaluation based on Vita and 3D Master scales and with a spectrophotometer Vita Easyshade (Vita Zahnfabrik / Bad Saeckingen, Germany) based on CIEL*a* b system. Data collected will be evaluated for translucency parameter (TP) and color variation (ΔE) according to luting agent, thickness and color of the LVs as well as color of dental substrate. Additionally, the color obtained with visual evaluation and with spectrophotometer will be compared to evaluate the level of agreement between the color observed by the operator and the color named by the spectrophotometer.
16058610|NCT02464540|Procedure|Laminate veneers luted with light-cured flowable composite|After the use of light-cured luting agent the color of laminate veneers will be performed with visual evaluation based on Vita and 3D Master scales and with a spectrophotometer Vita Easyshade (Vita Zahnfabrik / Bad Saeckingen, Germany) based on CIEL*a* b system. Data collected will be evaluated for translucency parameter (TP) and color variation (ΔE) according to luting agent, thickness and color of the LVs as well as color of dental substrate. Additionally, the color obtained with visual evaluation and with spectrophotometer will be compared to evaluate the level of agreement between the color observed by the operator and the color named by the spectrophotometer.
16058611|NCT02464527|Behavioral|Stimulus-stimulus pairing|The participants will attend clinic-based treatment sessions for one hour per day, five days per week, for 6-weeks.The stimulus-stimulus pairing procedure will consist of sounds and words being systematically paired with delivery of a preferred item.
16058612|NCT02464527|Other|Vocal recorder|The vocal recorder is a voice recording device that enhances vocalization data. The parent/ guardian will be instructed on how to use the vocal recorder. The vocal recorder will then be deployed at the participant's homes via parent/guardian. The parent/guardian will record vocalizations for approximately 1 hour while in the home or community setting pre, mid, and post treatment. The parent/guardian will return the vocal recorder to the study team for analysis of the recordings.
16058613|NCT02464514|Other|High carbohydrate meal|65% carbohydrate, 17% protein, and 18% fat
16058614|NCT02464514|Other|High fat meal|58% fat, 17% protein, and 25% carbohydrate
16058615|NCT02464501|Other|Paclitaxel administration using the OPC|
16058616|NCT02464488|Other|Plasma drug concentrations|Measure of plasma concentrations of the anticoagulant drug taken by the patient
16058617|NCT02464475|Other|osteopathic manipulative treatment|
16058618|NCT02464475|Other|sham osteopathic treatment|
16058619|NCT02464462|Dietary Supplement|vitamin D3 and calcium|1800 IU vitamin D3 plus 720 mg Calcium
16058620|NCT02464462|Other|Placebo|Rice powder pills
16058621|NCT02464449|Behavioral|Behavioral: AI-CBT|AI CBT engine will make recommendations to step-down or step-up intensity of CBT follow-up based on what patient reports and what other similar patients report. Stepped care model.
16058622|NCT02464449|Behavioral|Behavioral: Standard Telephone CBT|Controls receive 10 hour-long standard telephone CBT sessions, a pedometer/log after baseline, and a Patient Handbook.
16058623|NCT02464436|Drug|hRPC|Participants will undergo vitrectomy surgery and subretinal implantation of hRPC in the study eye.
16058624|NCT02464423|Behavioral|Trauma-Informed Cognitive Behavioral Therapy enhanced (TI-CBTe)|
16058625|NCT02464410|Behavioral|Motivational intervention|The intervention session combines elements of motivational enhancement (ME) and cognitive behavioral therapy (CBT). Similar to other ME brief interventions, the intervention content will be covered in a single session. Participants are presented with a variety of risk reduction strategies and strategies for coping with pain that may reduce reliance on opioids for managing pain.
16058626|NCT02464410|Behavioral|Psycho-educational control|The educational control condition provides educational content related to the biology of pain response and an overview of pain conditions. The overall style is didactic.
16058818|NCT02462876|Device|GORE® VIABAHN® Endoprosthesis|Treatment of Popliteal Artery Aneurysm with the GORE® VIABAHN® Endoprosthesis.
16058627|NCT02464410|Other|Long-term opioid therapy informed consent|The Veterans Health Administration instituted a requirement that all patients receiving long-term opioid therapy receive an informed consent process that reviews the risks of opioid therapy. All individuals eligible for this study will meet this definition of long-term opioid therapy. The study therapists for both study arms will deliver the informed consent process during the sessions as part of treatment as usual.
16058628|NCT02464397|Device|Stent|In the study, either OPTIMAX or SYNERGY stent will be implanted in coronary artery lesion
16058629|NCT02464384|Procedure|Venipuncture, ultrasound, MRI, x-ray|Collection of blood samples and ultrasound / MRI and x-ray examination
16058630|NCT02464371|Other|kinetic of microRNAs|blood samples will be drawn to measure microRNAs
16058631|NCT02464358|Behavioral|IMB Intervention Group|Participants in the IMB group received information specific to HPV, cervical cancer, and the HPV vaccine. This information was delivered in a group setting, and it was delivered via a PowerPoint presentation that included short video clips.
16058632|NCT02464358|Behavioral|Attention Control|Participants in the attention control arm watched a PowerPoint that contained a series of short video clips encompassing aspects of women's general and sexual health. This was also conducted in a group setting.
16058633|NCT02464345|Behavioral|HAPIFED|HAPIFED is adapted from CBT to promote a positive relationship with food, eating and activity, appetite awareness, and weight loss to be achieved over a longer and more intensive period of therapy, thus recognizing the importance of longer-term therapy in weight loss (Casazza et al., 2013). Notably, HAPIFED is also multidisciplinary. Clinical practice and consensus views are to utilize the special expertise of dietitians and other allied health professionals (Robinson, 2009).
16058634|NCT02464345|Behavioral|CBT-E|CBT-E therapy
16058635|NCT02464332|Drug|BLZ-100|"All subjects enrolled in the study will receive doses of BLZ-100, an investigational drug for imaging tumors.
~Three different imaging windows will be investigated during the study:
~Early Imaging (imaging occurs within 1 day post-BLZ-100 dose); Intermediate Imaging (imaging occurs within 2-3 days post-BLZ-100 dose); Late Imaging (imaging occurs 4-7 post-BLZ-100 dose)
~All subjects in Part 1 of the study will be imaged in the Intermediate Imaging group. Subjects in Part 2 of the study will be randomized into one of the three imaging groups."
16058636|NCT02464319|Drug|hrIL-2 active|1 million U doses of human recombinant interleukin-2 s.c. injection active group: placebo group =1:1
16058637|NCT02464319|Drug|hrIL-2 placebo|1 million U doses of placebo s.c. injection active group: placebo group =1:1
16058638|NCT02464306|Drug|fidaxomicin|Patients will be treated with fidaxomicin 200 mg PO twice daily for 10 days.
16058639|NCT02464293|Other|Mindfulness-based cognitive therapy|An 8 week course of mindfulness-based cognitive therapy
16058640|NCT02464280|Other|Tomosythesis scan of the lung or the wrist|All study participants will undergo Tomosynthesis imaging of the lung or the wrist. The radiation dose of each method will be recorded.
16058641|NCT02464280|Other|CT scan of the lung or the wrist|All study participants will undergo CT imaging of the lung or the wrist, for which they where originally scheduled. The radiation dose of each method will be recorded.
16058642|NCT02464280|Other|conventional X-ray of the lung or the wrist|All study participants will undergo conventional X-ray of the lung or the wrist, for which they where originally scheduled. The radiation dose of each method will be recorded.
16058643|NCT02464254|Behavioral|Physical activity plus positive affect|Subjects will be randomized to a physical activity goal and will receive the positive affect component.
16058644|NCT02464254|Behavioral|Physical activity plus education|Subjects will be randomized to a physical activity goal and will receive the educational component.
16058645|NCT02464241|Other|only examination|
16058646|NCT02464228|Drug|Tipifarnib|oral
16058647|NCT02464215|Procedure|open surgery|Subtotal gastectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dessection(around common hepatic artery, celiac artery, proximal part of splenic artery, hepatoduodenal ligament, superior mesenteric vein) will be performed basically.
16058648|NCT02464215|Procedure|laparoscopic surgery|Patients in this arm undergo radical resection of gastric cancer in laparoscopic surgery.10 mm trocar under umbilicus, 12 mm and 5 mm trocar at the right flank area are inserted into abdominal wall. Another two 5 mm trocar are inserted into the both midline of subcostal line. The devices for operation are inserted through the trocars. Subtotal gastrectomy (dissect more than 2/3 of stomach and total omentectomy) and D2 lymph node dissection (around common hepatic artery, celiac artery, proximal part of splenic artery, hepatoduodenal ligament, superior mesenteric vein) will be performed basically. Dissected stomach and lymph node are collected through additional 5-10 cm incision at the preexisting epigastric incision.
16058649|NCT02464202|Other|stereolithography tooth replica|Tooth replica will be made and used for preparing the receiving tooth socket during autotransplantation
16058650|NCT02464189|Other|Q-Kap|
16058651|NCT02464176|Drug|Dexamethasone|A lumbar plexus nerve block will be performed for patients undergoing hip arthroplasty. A total of 25cc's of 0.25% bupivacaine with 1:400,000 epinephrine will be administered for postoperative analgesia. Surgical anesthesia will be provided either by an intrathecal spinal block or general anesthesia. Successful blockade will be assumed if the patient has a decrease or loss of pinprick sensation in the femoral nerve distribution, which innervates the anterior thigh. If no evidence of blockade is present, testing will occur again at 30 minutes post block. Testing will be performed with a 25 gauge Whitacre needle and once present the area of testing will be marked with a surgical marking pen so that repeat sensory testing can be undertaken at that same site over the course of the study. The subjects will then receive dexamethasone (4 or 8 mg) or placebo (saline) based on arm placement.
16058652|NCT02464176|Drug|Bupivacaine|Bupivacaine will be used in lumbar plexus nerve block mixture.
16058653|NCT02464176|Drug|Epinephrine|Epinephrine will be used in lumbar plexus nerve block mixture.
16058654|NCT02464176|Procedure|Lumbar Plexus Nerve Block|This is the procedure that will be performed.
16058655|NCT02464176|Drug|Saline|Patients randomized to the placebo group will receive normal saline intravenously.
16058656|NCT02464163|Biological|Panblok|Intramuscular injection
16058657|NCT02464163|Biological|rHA adjuvant|Intramuscular injection
16058658|NCT02464150|Dietary Supplement|Gluten challenge|Challenge done in the form of a gluten containing cookie once daily, or up to four slices of regular bread daily.
16058819|NCT02462863|Dietary Supplement|Arginine and fish oil|Dietary supplements
16058820|NCT02462850|Drug|CL-108|
16058659|NCT02464137|Radiation|radiation|Patients in each dose cohort will all be treated as a single group. The starting dose will be 8.5 Gy per fraction for 5 fractions (total dose = 42.5 Gy). Subsequent cohorts of patients will receive an additional 0.5 Gy per fraction.
16058660|NCT02464124|Drug|Nitazoxanide|• Nitazoxanide dosing: 500 mg tablets twice daily
16058661|NCT02464124|Drug|Lactulose|• Lactulose dosing: 30-60 mL PO TID with goal 2-3 semisoft stools per day
16058662|NCT02464111|Other|Treatment 1: Control|No supplement provided.
16058663|NCT02464111|Dietary Supplement|Treatment 2: Bolus (LNS)|One LNS supplement provided in a single bolus dose in the morning
16058664|NCT02464111|Dietary Supplement|Treatment 3: Divided Dose (LNS)|One LNS supplement provided in 3 separate portions throughout the study visit
16058665|NCT02464085|Other|Longitudinal evaluation of recovery|Stroke survivors will be assessed at four time frames post stroke to evaluate neuroplastic and clinical changes in arm recovery over the first 12-months post stroke.
16058666|NCT02464072|Procedure|Subtotal Parathyroidectomy|Subtotal parathyroid resection leaving the estimated mass of two normal parathyroid glands in situ. The type of operation is the intervention. No new device or drug is involved.
16058667|NCT02464072|Procedure|Total Parathyroidectomy + 45 autografts|Immediate autograft of 45 fragments of parathyroid tissue, after a total parathyroidectomy.This type of operation is the standard intervention at the institution at the moment. No new device or drug is involved.
16058668|NCT02464072|Procedure|Total Parathyroidectomy + 90 autografts|Immediate autograft of 90 fragments of parathyroid tissue, after a total parathyroidectomy.The type of operation is the intervention. No new device or drug is involved.
16058669|NCT02464059|Drug|Vitamin D3|Oral supplementation with 50,000 IU vitamin D3 weekly for eight weeks in individuals with reduced vitamin D levels.
16058670|NCT02464046|Drug|JNJ-42847922|Participants in arm JNJ-42847922 then Placebo will receive 2*20 mg tablet of JNJ-42847922 orally once daily from Day 1 to Day 5 in Period 1 and participants in arm Placebo then JNJ-42847922 will receive 2*20 mg tablet of JNJ-42847922 orally once daily from Day 1 to Day 5 in Period 2.
16058671|NCT02464046|Drug|Placebo|Participants in arm JNJ-42847922 then Placebo will receive matching Placebo orally once daily from Day 1 to Day 5 in Period 2 and participants in arm Placebo then JNJ-42847922 will receive matching placebo orally once daily from Day 1 to Day 5 in Period 1.
16058672|NCT02464033|Drug|GAD-Alum|Recombinant Human Glutamic Acid Decarboxylase (rhGAD65)
16058673|NCT02464033|Drug|Vitamin D|
16058674|NCT02464033|Drug|Etanercept|
16058675|NCT02464020|Drug|Vancomycin|Oral vancomycin: 500mg suspended in prefilled syringes for oral use
16058676|NCT02464007|Biological|rSIFN-co|Artificial recombinant super-compound interferon (rSIFN-co) is a product of patented technological research made possible through protein modulation by spatial conformation control technology, and was developed by Sichuan Huiyang Life Science and Technology Corporation.
16058677|NCT02463994|Drug|MPDL3280A|Patients will receive 1,200 mg I.V. Q 3 weeks of MPDL3280A until progression.
16058678|NCT02463994|Radiation|Hypofractionated Radiotherapy|Hypofractionated Image-Guided Radiotherapy (HIGRT)
16058679|NCT02463981|Device|real-time fMRI neurofeedback training running on Turbo Brain voyager (TBV) 3.2 (Brain Innovation, Maastricht, The Netherlands)|
16058680|NCT02463968|Procedure|Venipuncture for blood draw|Samples will include blood. Blood samples will be collected via venipuncture.This is a part of standard of care of new new onset joint effusion and is not a novel intervention.
16058681|NCT02463968|Procedure|Arthrocentesis for synovial fluid draw|Samples will include joint fluid analysis in participants with a knee effusion. Synovial fluid will be drawn via arthrocentesis under sterile conditions. This is a part of standard of care of new new onset joint effusion and is not a novel intervention.
16058682|NCT02463955|Device|flexible video endoscope|Thoracoscopy is done using flexible video endoscope
16058683|NCT02463955|Device|video-rigid thoracoscope|Thoracoscopy is done using video-rigid thoracoscope
16058684|NCT02463942|Drug|Doxycycline|Beside symptomatic therapy, patients will receive oral Doxycycline 100 mg, Doxy® twice daily.
16058685|NCT02463942|Drug|Symptomatic therapy|Patients will receive symptomatic therapy with antipyretics, analgetics, antiemetics, and parenteral hydration: metamizole, Analgin®, paracetamol, Lekadol®, thiethylperazine, Kytril®, saline.
16058686|NCT02463942|Other|Questionnaire|Subjects will be asked to answer a questionnaire asking about the presence and frequency of nonspecific symptoms such as headache, fatigue, arthralgia, myalgia.
16058687|NCT02463929|Drug|Diphenhydramine|Intravenous Injection
16058688|NCT02463929|Drug|normal saline|Intravenous Injection
16058689|NCT02463929|Drug|Ketamine|Ketamine 0,1 mg/kg intravenously used as rescue tranquilizer if the subject becomes agitated, repeated dose of 0,05 mg/kg every minute can be given if the agitation does not resolve, maximum ketamine dose for tranquilizer 0,25 mg/kg to prevent deep sedation
16058690|NCT02463929|Drug|Sevoflurane|Sevoflurane as single sedation agent for general anesthesia in both arm. 8% Sevoflurane in 100% oxygen used as induction agent, and 2% sevoflurane in 50% oxygen used as maintenance agent
16058691|NCT02463929|Drug|Bupivacaine|Bilateral extraoral infraorbital nerve block with 0,125% Bupivacaine as analgetic for operation and post operation.
16058692|NCT02463916|Other|Exercise|8 week structured exercise programme
16058693|NCT02463903|Behavioral|Coping Effectiveness Training (CET)|The participants in the intervention group will receive a work book explaining the theme and home assignment as well as providing a brief summary of every group session. The group leader has a manual. Both work book and manual have been translated to Swedish and adjusted to patients with chronic heart failure.
16058694|NCT02463890|Other|Training|
16058695|NCT02463890|Other|Control|
16058696|NCT02463877|Procedure|Minimally-Invasive Procedure|Laparoscopy
16058697|NCT02463864|Other|Intervention exercise|Twice daily, individual, targeted, strengthening, balance and endurance exercises for the duration of the hospital stay, prescribed and delivered by a senior physiotherapist.
16058698|NCT02463864|Other|Sham Exercise|Twice daily stretching and relaxation exercises for the duration of the hospital stay, by a senior physiotherapist.
16058699|NCT02463851|Device|PVAC GOLD multielectrode catheter|Cardiac ablation for Atrial Fibrillation
16058700|NCT02463851|Device|Contact Force single-tip ablation catheter|
16058821|NCT02462837|Drug|Mirabegron|
16058822|NCT02462837|Drug|Placebo|
16058701|NCT02463838|Other|Care Support Intervention|Case management and care coordination intervention delivered in person to SFHP members who are frequent users of emergency department and inpatient hospital services.
16058702|NCT02463825|Drug|Pimozide 2 mg per day|
16058703|NCT02463825|Drug|Pimozide 4 mg per day|
16058704|NCT02463825|Drug|Placebo (Lactose tablet)|
16058705|NCT02463812|Drug|Intralipid|
16058706|NCT02463812|Drug|Saline|
16058707|NCT02463799|Drug|Radium-223|6 infusions of radium-223 with 3 infusions of sipuleucel-T starting after second dose of radium-223
16058708|NCT02463799|Biological|Sipuleucel-T|3 infusions of sipuleucel-T alone
16058709|NCT02463786|Other|No intervention|No intervention
16058710|NCT02463773|Device|Ultrasound|Diaphragmatic excursion ultrasound assessment
16058711|NCT02463760|Other|Medical imaging|
16058712|NCT02463747|Drug|Piperacillin/tazobactam|Initial treatment will be with Piperacillin + Tazobactam
16058713|NCT02463747|Drug|Ceftazidim|Patient with sensitivity to penicillin will receive Ceftazidim
16058714|NCT02463747|Drug|Meropenem|In cases of hypotension that do not respond to fluids resuscitation , and in consultation with the infectious diseases unit - we will start empirical treatment with Meropenem
16058715|NCT02463747|Drug|Vancomycin|Supplementation of Vancomycin will be at the discretion of the treating physician
16058716|NCT02463721|Other|ascitic fluid culture and microbiological testing|ascitic fluid culture and microbiological testing for 100 patients with liver cirrhosis and ascites with suspicion of SBP
16058717|NCT02463708|Behavioral|BHL COTP|The BHL COTP starts with an initial baseline assessment; following the baseline assessment, it is then divided into several core services. CG receive care management services, which includes contact, support, and active listening, as well as written material regarding caregiving and dementia and referral to appropriate community services. CGs also are offered the Telehealth Education Program (TEP) a manualized program developed to provide both education and psychosocial support for individuals caring for older adults with clinically significant cognitive impairment/dementia.
16058718|NCT02463695|Procedure|cortical vestibular evoked potentials (CVEPs)|CVEPs utilise an existing method used to interrogate cortical projections from the auditory system in which sound waves stimulate the inner ear and the resulting electrical responses from the brain are recorded (known as Cortical Auditory Evoked Potentials CAEPs)
16058719|NCT02463682|Device|CGM and Insulin Pump|Dexcom G4 Platinum CGM with Share AP Receiver Roche Accu-Chek insulin pump
16058720|NCT02463682|Device|Closed-Loop Control System|"The devices that will be used in the Closed-Loop Control System include the following components:
~DiAs - a smart-phone medical platform; Dexcom Dexcom G4 Platinum connected to DiAs via Bluetooth CGM receiver; Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth; Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network, and Zone-MPC and HMS algorithms running on DiAs (MPC and HMS)"
16058721|NCT02463669|Device|Point-of-care ultrasound|Enrolled patients will undergo POCUS of the spleen by the treating emergency physician (resident, fellow or attending). Canadian Emergency Ultrasound Society (CEUS) certified residents, fellows and attending physicians will conduct the bedside ultrasonography after receiving specific training for the purposes of this study. The spleen will be assessed using a curved 2-6 Megahertz (MHz) transducer with the participant in the supine position. The cranio-caudal splenic length will be measured and its maximum dimension will be recorded on the standardized study data sheet.
16058722|NCT02463643|Drug|Z-215 10mg|Z-215 10mg, capsules
16058723|NCT02463643|Drug|Z-215 20mg|Z-215 20mg, capsules
16058724|NCT02463643|Drug|Z-215 Placebo|Z-215 placebo-matching capsules
16058725|NCT02463643|Drug|Rabeprazole Sodium|Rabeprazole Sodium 10mg tablets
16058726|NCT02463643|Drug|Rabeprazole Sodium Placebo|Rabeprazole Sodium Placebo placebo-matching tablets
16058727|NCT02463630|Procedure|Posterior Approach Compression Distraction Reduction|Patients was placed in prone position. Via midline skin incision, expose the occipital squama and spinal process, vertebral plate and facet joints of C2. 2 multi-axial screws were inserted into the bilateral C2 or C3 pedicles. The posterior edge of the FM up to the lower boundary of cerebellar tonsil (width, 3mm) was removed. A compression occipital plate (COP) was fixed to the occipital bone. 2 titanium rods connect C2/C3 screws and plate heads bilaterally. The COP screw cap was screwed in, compress the beginning of the pre-bending formed titanium rod downward, driving the odontoid process forward to restore the horizontal dislocation. After restoration of horizontal dislocation is confirmed, applying distraction force between the occipital screw and the C2 pedicle screws, restore the vertical dislocation. tight up the screw cap. Graft bone was harvested from the posterior inferior iliac crest bone and implanted into posterior end of the foramen magnum and posterior lamina of axis.
16058728|NCT02463617|Other|magnetic resonance imaging|
16058729|NCT02463604|Procedure|Coronary Angiography|Coronary angiography is performed following usual site standards
16058730|NCT02463591|Drug|Beriplex|Beriplex 50 IU/Kg i.v. , single dose.
16058731|NCT02463565|Other|no intervention|
16058732|NCT02463552|Drug|Naproxen|The patient will receive a single-dose of Naproxen (500 mg) one hour before the bleaching procedure.
16058733|NCT02463526|Other|Mobilization with Movement (MWM) condition/ Sham condition|The treatment condition consists in the application of a posterolateral glide (MWM) in the affected shoulder. Subjects will be seated and the therapist will stay beside the participants on the opposite side to the affected shoulder. One hand will be placed over the scapula posteriorly while the thenar eminence of the other hand will be placed over the humerus head anterior aspect. A posterior glide will be applied to the humeral head. Three sets of 10 repetitions will be applied with a 30 seconds rest interval between each set. Sham condition will replicate treatment condition except for the hand positioning. The therapist will place one hand along the clavicle and the other on the humeral head posterior aspect of the affected shoulder. A simulated anterior glide will be performed.
16058852|NCT02462642|Other|Placebo|Placebo capsules - Dry starch filled in identical hard gelatin capsules
16058853|NCT02462629|Drug|BLZ-100|
16058854|NCT02462616|Other|not intervention|This is a cross-sectional study, no intervention was performed.
16058855|NCT02462603|Drug|EPI-589|EPI-589 is a redox active molecule and will be provided in a 250 mg tablet formulation.
16058856|NCT02462590|Drug|L. rhamnosus GG - Probiotic|Twice daily, patients will receive either 1x1010 colony forming units (CFU) of L. rhamnosus GG (Culturelle, Locin Industries Ltd) in 1 capsule or an identical placebo capsule
16058734|NCT02463526|Other|Sham condition/ Mobilization with Movement (MWM) condition|The Sham condition consists in the application of a simulated anterior glide in the affected shoulder. Subjects will be seated and the therapist will stay beside the participants on the opposite side to the affected shoulder. The therapist will place one hand along the clavicle and the other on the humeral head posterior aspect of the affected shoulder. A simulated anterior glide will be performed. Three sets of 10 repetitions will be applied with a 30 seconds rest interval between each set. The treatment condition will replicate treatment condition except for the hand positioning. The therapist will place one hand over the scapula posteriorly while the thenar eminence of the other hand will be placed over the anterior humerus head. A posterior glide will be applied to the humeral head.
16058735|NCT02463513|Dietary Supplement|Placebo comparator|2 week placebo washout + 16 weeks intervention (placebo)
16058736|NCT02463513|Dietary Supplement|1.6mg riboflavin (Vitamin B2)|2 week placebo washout + 16 weeks intervention (1.6mg riboflavin per day)
16058737|NCT02463513|Dietary Supplement|10mg riboflavin (Vitamin B2)|2 week placebo washout + 16 weeks intervention (10mg riboflavin per day)
16058738|NCT02463500|Other|DFU|Standard care.
16058739|NCT02463487|Device|Cardinal Pro +Simultaneous Irrigation (NPWTi)|NPWT with low volume irrigation (15 cc/hr) with 1% polyhexanide biguanide (PHMB), Prontosan®
16058740|NCT02463487|Device|Cardinal Pro (NPWT) Therapy|NPWT 125 mm Hg continuous pressure with foam interface
16058741|NCT02463474|Behavioral|mHealth Intervention|Ten, short, engaging, entertaining and culturally relevant videos delivered to participants' cell phones provide breast cancer health information.
16058742|NCT02463461|Device|ActiSleep Activity Monitor|Subjects in this group will wear a ActiSleep Activity Monitor.
16058743|NCT02463461|Device|Jawbone Activity Monitor|Subjects in this group will wear a Jawbone Activity Monitor.
16058744|NCT02463461|Device|Actiwatch 2 Activity Monitor|Subjects in this group will wear a Actiwatch 2 Activity Monitor.
16058745|NCT02463461|Device|FitBit Activity Monitor|Subjects in this group will wear a FitBit Activity Monitor.
16058746|NCT02463461|Device|Actigraph by Ambulatory Monitoring Activity Monitor|Subjects in this group will wear a Actigraph by Ambulatory Monitoring Activity Monitor.
16058747|NCT02463448|Biological|Autologous Muscle Derived Cells|A small sample of the subject's own thigh muscle is obtained by needle biopsy. The biopsy sample is sent to Cook Myosite, Inc. for growth and processing. When the sample cell dosage is achieved the cells are frozen and sent back to the treatment site. The cells are thawed, diluted and injected under lighted instrumentation and visualization into about 30 sites in the bladder wall.
16058748|NCT02463435|Behavioral|Nutritional intervention|Conventional treatment (Nutritional intervention) consists of prescription of individualized food plan to reduce 5 to 10% of initial body weight, nutritional counseling for comorbidities and promoting healthy eating habits and physical activity.
16058749|NCT02463435|Other|Nutritional intervention plus olive oil|Nutritional intervention consists of prescription of individualized food plan to reduce 5 to 10% of initial body weight, nutritional counseling for comorbidities and promoting healthy eating habits and physical activity. Additionally, dietary supplementation with extra virgin olive oil (52 mL daily) will be held, divided in four (4) sachets per day, two (2) at lunch and two (2) at dinner.
16058750|NCT02463435|Dietary Supplement|Olive oil|Patients will be instructed to maintain habitual food consumption and consume 52 mL of extra virgin olive oil daily in four (4) sachets per day, two (2) at lunch and two (2) at dinner.
16058751|NCT02463409|Drug|Theophylline|24 hour infusion of IV theophylline
16058752|NCT02463396|Behavioral|MBCT for ADHD|
16058753|NCT02463383|Drug|Ibuprofen Tab 400 MG|400mg ibuprofen is provided and an alcohol challenge (0.4g/kg bw) is given 30min later
16058754|NCT02463383|Drug|Placebo tab|A placebo tablet is provided and an alcohol challenge (0.4g/kg bw) is given 30min later
16058755|NCT02463370|Other|suprazygomatic maxillary area infiltration|Local anesthetic infiltration in two injections on each side of the face at the maxillary and infra-orbital areas.
16058756|NCT02463370|Other|non-suprazygomatic maxillary area placebo|The remaining injections at supratrochlear area, medial to the medial canthus, nasal still and anterior septum are placebo (saline)
16058757|NCT02463370|Other|non-suprazygomatic maxillary area infiltration|Local anesthetic infiltration in five injections on each side of the face at the infra-orbital area, supratrochlear area, medial to the medial canthus, nasal still and anterior septum.
16058758|NCT02463370|Other|suprazygomatic maxillary area placebo|The remaining maxillary injection is placebo.
16058759|NCT02463357|Dietary Supplement|Quercetin|
16058760|NCT02463357|Drug|Nifedipine extended release|
16058761|NCT02463357|Drug|Methazolamide|
16058762|NCT02463357|Drug|Metformin|
16058763|NCT02463357|Drug|Placebo|
16058764|NCT02463357|Drug|Nitrite|
16058765|NCT02463344|Biological|MA09-hRPE|Cohort 1 50,000 cells Cohort 2 100,000 cells Cohort 2a Better Vision 100,000 cells Cohort 3 150,000 cells Cohort 4 200,000 cells
16058766|NCT02463331|Drug|Chloroquine diphosphate|One pill of chloroquine diphosphate per day until the end of the study
16058767|NCT02463331|Drug|prednisone|Prednisone 5-15 mg/day until the end of the study
16058768|NCT02463331|Drug|azathioprine|azathioprine 1-2mg/Kg/day until the end of the study
16058769|NCT02463318|Drug|Melatonin|Melatonin is used for healthy subjects and multiple sclerosis patients
16058770|NCT02463318|Other|Hydrogen peroxide|Hydrogen peroxide is only used for healthy subjects
16058771|NCT02463305|Drug|Creatine monohydrate|21 grams creatine monohydrate total per day
16058772|NCT02463305|Other|Placebo|7 grams of dextrose dissolved in 500mL water, taken three times daily
16058773|NCT02463292|Other|no intervention|no intervention
16058774|NCT02463279|Device|Sinusys Dilation System|Dilation of frontal recess and/or sphenoid sinus ostia
16058857|NCT02462590|Drug|Placebo - Microcrystalline Cellulose|Microcrystalline Cellulose
16058858|NCT02462577|Drug|local instillation of morphine to surgical wound|comparison between different drug doses effects on pain
16058859|NCT02462551|Device|Focal Electrically Administered Seizure Therapy|A focal administration of the right unilateral configuration of electro-convulsive therapy for the treatment of recurrent and treatment-resistant depression.
16059029|NCT02461394|Device|Blood glucose monitoring systems for self-testing|
16058775|NCT02463266|Behavioral|SUSTAIN Monitoring and Care Management|Program participants are offered clinical services based on symptom severity and clinical need. Follow-up Monitoring consists of up to 4 brief, structured assessments following the baseline clinical assessment. These follow-up contacts are conducted over the telephone by the HT/BHP and take place during the initial 12 weeks of pharmaceutical treatment. These brief interviews monitor symptoms, adherence, side effects, and response to treatment. Care Management incorporates the use of a BHP who has expertise in mental health assessment and is well versed in the delivery of algorithm-based management strategies. The BHP monitors and encourages patient acceptance and adherence to treatment recommendations through support, education, and motivational engagement.
16058777|NCT02463214|Other|Engineered Room|"Touchless devices:
~Hand sanitizers, faucets, paper towel dispensers, call devices, Ultraviolet C Aseptix™ Disinfection devices above bathroom doors
~Copper products:
~Room and bathroom entrance door hardware, over bed table and bed side table surfaces, chair metal arms, wardrobe handles and knobs, weigh scale, sinks, grab bars, light switch panels, toilet flush handles, faucets and handles, patient bed rails.
~Titanium dioxide paint:
~Room walls, head walls, light switches, bathroom wall shelves, toilet tank and bowl, head wall unit fixed equipment, television remote and Bed Control remote"
16058778|NCT02463201|Behavioral|Weight loss|
16058779|NCT02463188|Behavioral|Sleep Fitness Intervention|The intervention consists of 5-7 sessions. Each session includes interactive and small group discussions. The intervention also includes lessons on sleep science, behavior change strategies, and one-on-one motivational interviews on behavior change motivation.
16058780|NCT02463175|Drug|Plasmalyte|Boluses of 5ml/kg of plasmalyte
16058781|NCT02463175|Procedure|Goal-directed fluid therapy (GDT)|Intraoperative goal-directed fluid therapy (GDT)
16058782|NCT02463162|Other|Conversations Matter videos|2 videos about Advance Care Planning and Goals of Care Designations respectively. These 2 videos were developed by Alberta Health Services and are each 8 minutes long.
16058783|NCT02463149|Behavioral|Youth Chef Academy|Nutrition and culinary curriculum delivered in the classroom
16058784|NCT02463136|Behavioral|questionnaires|Clinical questionnaires and behavioural computer-based paradigms, such as the Overlap task (Cohen Kadosh et al., 2014)
16058785|NCT02463136|Device|Functional magnetic resonance imaging w neurofeedback|"The general framework of the scanning part of this experiment consists of a localiser task (lasting approximately 8 minutes), 4 neurofeedback runs (each lasting approximately 5 minutes) and an anatomical scan (approximately 10 minutes).
~Immediately prior and following the scanning session, participants will also be asked to completed several), as well as an attentional control task with emotional stimuli, such as a behavioural version of the Overlap task (Cohen Kadosh et al., 2014)."
16058786|NCT02463123|Device|Indirect calorimetry|Resting energy expenditure will be studied using indirect calorimeter CCM Express (Medgraphics Inc, USA).
16058787|NCT02463110|Drug|Sertraline|Sertraline one capsule (50mg per day), which can be increased up to 200mg per day (maximum dose) for 6 months.
16058788|NCT02463110|Drug|No treatment|
16058789|NCT02463110|Drug|Placebo|
16058790|NCT02463097|Device|Insulin Pump|Closed Loop Algorithm
16058791|NCT02463084|Other|Low Diet|a 28-day course of 3 meals per day plus 2 snack that are either low in saturated fats, glycemic index and salt.
16058792|NCT02463084|Other|High Diet|a 28-day course of 3 meals per day plus 2 snack that are either high in saturated fats, glycemic index and salt.
16058793|NCT02463071|Drug|AZD0585|1g soft capsule
16058794|NCT02463071|Drug|AZD0585 placebo|1g soft capsule
16058795|NCT02463058|Other|exercise under hot and humid conditions protocol|"acclimatization day protocol: 2 hour effort performed in a climatic chamber, which include walk on a treadmill at 5 Km/h on a 2% incline under heat conditions (40 deg. centigrade & 40% RH) Core (rectal) and skin temperature and heart rate will be monitored continuously
~experiment days (3 days): 2 hour effort (2 cycles of: 50 min walk and 10 min rest-sitting) performed in a climatic chamber, which include walk on a treadmill at 5 Km/h on a 2% incline under heat conditions (30 deg. centigrade & 60% RH) Core (rectal) and skin temperature and heart rate will be monitored continuously."
16058796|NCT02463045|Drug|TOP1288|
16058797|NCT02463032|Drug|GTx-024|To determine whether either or both doses result in an acceptable clinical benefit rate.
16058798|NCT02463019|Drug|Tenofovir Disoproxil Fumarate|Tenofovir Disoproxil Fumarate
16058799|NCT02463006|Drug|Porous variant of Bioactive Glass.|Flap surgery with Porous variant of Bioactive Glass.
16058800|NCT02463006|Drug|Non porous variant of Bioactive Glass.|Flap surgery with non-Porous variant of Bioactive Glass.
16058801|NCT02462993|Drug|Aloe Vera|Local drug delivery of aloe vera gel
16058802|NCT02462967|Drug|GR-MD-02|GR MD 02 (galactoarabino rhamnogalacturonate), a complex carbohydrate drug that binds to galectin 3
16058803|NCT02462967|Drug|Placebo|Placebo for GR-MD-02
16058804|NCT02462954|Device|ContraGel|
16058805|NCT02462954|Device|HEC Universal Placebo gel|
16058806|NCT02462941|Drug|Adenosine|Testing escalating doses of adenosine in pediatric heart transplant patients
16058807|NCT02462941|Procedure|Cardiac catheterization|(non-experimental) standard procedure
16058808|NCT02462928|Drug|Abicipar Pegol|Abicipar pegol intravitreal injection.
16058809|NCT02462928|Drug|Ranibizumab|Ranibizumab intravitreal injection.
16058810|NCT02462928|Other|Sham Procedure|Sham injection.
16058811|NCT02462915|Device|i-gel|"a supraglottic airway devices without cuff and the material was Styrene Ethylene Butadiene Styrene.
~gastric channel to the The gastric suction channel can facilitate venting and reduce the aspiration."
16058812|NCT02462915|Device|endotracheal tube|traditional and regularly use in many surgeries for maintaining the airway.
16058813|NCT02462915|Drug|lidocaine, propofol, fentanyl and cisatracurium|
16058814|NCT02462902|Drug|5% albumin Infusion|colloid, 5% albumin (250 ml over 15 to 30 minutes).
16058815|NCT02462902|Drug|0.9% sodium chloride solution|0.9% sodium chloride solution (total of 30ml/kg over 15 to 30 minutes)
16058816|NCT02462889|Drug|Intravitreal aflibercept injection|Intravitreal aflibercept injection
16058817|NCT02462889|Drug|Placebo|Sham injection
16058985|NCT02461758|Biological|Standard dose Influenza vaccine (SDIV)|
16058823|NCT02462824|Behavioral|Home-based exercise intervention|The home-based exercise intervention focuses on walking exercise and consists of two phases. Phase I (weeks 1-4) consists of four on-site visits to an exercise facility, where participants will meet the telephone coach, learn to use the Fitbit activity monitor, become familiar with the study website, learn behavioral skills necessary for long-term adherence to home-based exercise, and get started on their exercise program. Phase II (weeks 5-36) is entirely home-based and includes a) use of the Fitbit for self-monitoring; and b) regularly scheduled telephone calls from the study telephone coach to monitor and support participants' home exercise activity' c) use of the study website; d) optional group telephone calls.
16058824|NCT02462811|Drug|CL-108 (hydrocodone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)|
16058825|NCT02462811|Drug|Placebo|
16058826|NCT02462811|Drug|Norco (hyrdocodone 7,5 mg, acetaminophen 325 mg)|
16058827|NCT02462798|Other|Whole grain rye bread|Whole grain rye bread baked without sourdough fermentation (normal yeast-based fermentation)
16058828|NCT02462798|Other|Whole grain sourdough rye bread|Whole grain rye bread fermented with sourdough culture before baking
16058829|NCT02462785|Behavioral|In-person Carbohydrate Counting Class|An in-person carbohydrate counting class led by a registered dietician. The in class session covers topics including the role of CHO in nutrition and diabetes, sources of CHO, different CHO and non-CHO foods, resources for CHO counting, label reading, and meal planning. This is the standard procedure for CHO counting education at SickKids.
16058830|NCT02462785|Behavioral|Online Carbohydrate Counting Tutorial|A web-based CHO counting tutorial that covers the same concepts reviewed during the standard in-person instructional session held at SickKids. A teen delivers the educational messages in short segments using techniques designed to maintain the viewer's attention (e.g., visuals of food portions and short segment highlights to emphasize important points). The online module includes brief interactive question/answer components for reinforcement. The secure online tutorial will be accessible for one week through a link provided by REDCap. Users will be able to repeat sessions, log on and off during sessions, and choose specific modules for repetition/review. The investigators will be able to capture the number of times patients log on and detail frequency and specifics of usage.
16058831|NCT02462772|Drug|cabotegravir|Cabotegravir 30 mg tablets are formulated as white to almost white oval-shaped coated tablets for oral administration. The cabotegravir LA is formulated as a sterile white to slightly coloured suspension containing 400mg/2mL of cabotegravir LA for administration by IM injection.
16058832|NCT02462772|Drug|Placebo|Placebo tablets for cabotegravir are formulated as white to almost white oval-shaped coated tablets to visually match the active cabotegravir tablets. Placebo for cabotegravir injectable suspension is Intralipid® 20%. Intralipid® is a fat emulsion with no pharmacological action. It is a white, milky emulsion, consisting of purified soyabean oil, purified egg phospholipids and anhydrous glycerol. Intralipid® 20% is supplied in infusion bags.
16058833|NCT02462759|Drug|Nusinersen|Administered by intrathecal injection.
16058834|NCT02462759|Procedure|Sham Procedure|Small needle prick on the lower back at the location where the IT injection is normally made.
16058835|NCT02462746|Dietary Supplement|L-Cysteine|The trade name is New Root Herbal Inc.
16058836|NCT02462733|Behavioral|Tools of the Mind (TOM)|TOM is play-based but features explicit, scripted, teacher-directed activities aimed specifically at helping to improve children's self-control skills. Early evidence supports the program efficacy and suggests benefits for children's development more generally (including language, reading and mathematics).
16058837|NCT02462733|Behavioral|Playing to Learn (PTL)|PTl is a play based preschool program now in wide use in YMCA childcare settings across Canada (and some in the United States). The activities in PTL are child initiated and are not prescribed. Teachers are trained to observe children at play and to capitalize on learning opportunities as they arise.
16058838|NCT02462720|Drug|Varithena®|Varithena® treatment in accordance with full prescribing information and instructions for use
16058839|NCT02462720|Device|Radiofrequency ablation|Radiofrequency ablation conducted per physicians' standard of care.
16058840|NCT02462707|Drug|PF-03084014|gamma-secretase inhibitor, formulated in tablets for oral administration containing 10 mg, 50 mg and 100 mg. Patient will receive 80 mg, 100 mg or 150 mg twice daily of PF-03084014 with continuous dosing schedule
16058841|NCT02462694|Behavioral|Dialectical Behavior Therapy|Dialectical Behavior Therapy is an empirically validated treatment approach emphasizing the role of emotion regulation in the treatment of suicidal and self-destructive behaviors in BPD
16058842|NCT02462694|Behavioral|Treatment As Usual|TAU for these subjects involves close tracking by the Suicide Prevention Coordinator and treatment by their individual team of clinicians. Additionally, a support group with psychoeducation about suicide prevention will be offered as part of TAU
16058843|NCT02462681|Drug|paravertebral block|Thoracic paravertebral blocks will be performed as described by Moore and Katz. Intradermal lidocaine will be used at the site of the needle insertion. The superior aspect of the spinous processes of T1- T6 will be marked. The skin entry points will 3 cm laterals to the marks. A 22- gauge quincke spinal needle attach to extension tubing to a syringe containing study drugs will be used. The needle will be inserted perpendicular to the skin for a distance of 2 to 4 cm until the transverse process will contact. The needle will be withdrawn and walk cephalad off the transverse process and advance for a further 1.5 to 2 cm.
16058844|NCT02462668|Procedure|Bag-mask ventilation|The control group receives preoxygenation with bag-mask ventilation
16058845|NCT02462668|Procedure|Noninvasive positive pressure ventilation(NIPPV)|The NIPPV group receives noninvasive positive pressure ventilation during fibreoptic bronchoscopy assisted intubation
16058846|NCT02462668|Procedure|fibreoptic bronchoscopy assisted intubation|All patients will receive fibreoptic bronchoscopy assisted intubation.
16058847|NCT02462655|Other|Pre-lipid apheresis|Blood samples will be taken just before the start of the lipid apheresis treatment.
16058848|NCT02462655|Other|Post-lipid apheresis|Blood samples will be taken following the lipid apheresis treatment.
16058849|NCT02462642|Dietary Supplement|Brahmi|Brahmi extract - 225 mg filled in each hard gelatin capsule. Two such capsules per day, to be taken by the subjects for 12 weeks.
16058850|NCT02462642|Other|Placebo|Dry maize starch filled in identical hear gelatin capsule. Two such capsules will be taken by each subject per day for 12 weeks.
16058851|NCT02462642|Dietary Supplement|Brahmi|Brahmi Extract 225 mg filled in hard gelatin capsule. Two such capsules will be consumed by the subjects each day for 84 days.
16058860|NCT02462538|Drug|Brentuximab vedotin|Brentuximab vedotin is given in a 21 day cycle intravenously starting at 1.8 mg/kg on day 1 of the first cycle and will be administered by IV infusion given over approximately 30 minutes on day 1 of each 21-day cycle.
16058861|NCT02462538|Drug|Imatinib|Imatinib will be given orally at a dose of 100mg daily starting from day 1 of the first cycle. The dose will be increased to 200mg daily starting from day 1 of the second cycle if no DLT occurs during the first cycle and will be continued at 200mg for 48 weeks.
16058862|NCT02462525|Drug|ABBV-838|Varying doses of ABBV-838
16058863|NCT02462525|Drug|Pomalidomide|Administered orally per the label.
16058864|NCT02462525|Drug|Dexamethasone|Administered orally per the label.
16058865|NCT02462499|Drug|Inspra (eplerenone)|
16058866|NCT02462486|Drug|Abicipar Pegol|Abicipar pegol intravitreal injection.
16058867|NCT02462486|Drug|Ranibizumab|Ranibizumab intravitreal injection.
16058868|NCT02462486|Other|Sham Procedure|Sham injection.
16058869|NCT02462473|Drug|Aripiprazole|Participants will receive aripiprazole at a dose of 5 milligram (mg) or higher, as oral formulation once daily for 12 weeks as part of participant treatment.
16058870|NCT02462473|Drug|Olanzapine|Participants will receive olanzapine at a dose of 5 mg or higher, as oral formulation once daily for 12 weeks as part of participant treatment.
16058871|NCT02462473|Drug|Paliperidone|Participants will receive paliperidone 3 mg or higher dose as oral formulation once daily or 39 mg or higher dose once every 4 weeks for 12 weeks as part of participant treatment.
16058872|NCT02462473|Drug|Quetiapine|Participants will receive quetiapine at a dose of 150 mg or higher, as oral formulation once daily for 12 weeks as part of participant treatment.
16058873|NCT02462473|Drug|Risperidone|Participants will receive risperidone 1 mg or higher dose, as oral formulation once daily or as injection of 12.5 mg or higher dose once every 2 weeks for 12 weeks as part of participant treatment.
16058874|NCT02462460|Device|MRI|
16058875|NCT02462460|Behavioral|Optional Screening Questionnaire|
16058876|NCT02462447|Drug|11C-sarcosine|Radiotracer injection for PET/CT scan
16058877|NCT02462447|Drug|11C-choline|Radiotracer injection for PET/CT scan
16058878|NCT02462434|Behavioral|Early palliative care team consultation|The palliative care team will evaluate the patient and family with the following core palliative care goals in mind: evaluating maternal understanding of their child's diagnosis and eliciting maternal concerns regarding their child's physical symptoms, identifying maternal social support systems and additional life stressors, identifying maternal expectations and hopes for their child's medical care, and assessing maternal fears surrounding their child's diagnosis and medical treatments. Palliative care team support and resources will then be provided in areas of necessity identified for the family. Palliative care team follow up will then be determined based on the level of need identified for each individual study participant.
16058879|NCT02462421|Drug|Canagliflozin|A single dose of canagliflozin (300 mg, p.o.) will be administered prior to assessing pharmacodynamic response.
16058880|NCT02462408|Procedure|Posterior approach|The needle insertion point was over the trapezius muscle sufficiently posterior to allow the needle to pass between the clavicle and the scapula in the direction of the axillary artery. The insertion point was strictly aligned with the long axis of the ultrasound beam i.e. in-plane technique.
16058881|NCT02462408|Procedure|Conventional approach|The needle insertion point would be at the cephalad (lateral) aspect of the ultrasound probe, beneath the clavicle and medial to the coracoid process. The insertion point was strictly aligned with the long axis of the ultrasound beam i.e. in-plane technique.
16058882|NCT02462395|Device|tDCS|"Sponge-electrodes (5 x 7 cm) will be postioned at Fz (anode) and over the spinous process of C7 (cathode). Stimulation intensity will be set to 2 mA.
~A first group of CCH patients will have to apply the neurostimulation outside of an attack every day for 20 minutes during 4 weeks. A second group will use the tDCS device everyday for 8 weeks.
~Adherence to the treatment will be evaluated by monitoring the time during which the device is switched on via an in-built software."
16058883|NCT02462382|Procedure|Arthroscopic Rotator Cuff Repair|During arthroscopic rotator cuff surgery, the surgeon inserts a small camera, called an arthroscope, into your shoulder joint. The camera displays pictures on a television screen, and your surgeon uses these images to guide miniature surgical instruments to repair the torn ligament.
16058884|NCT02462382|Drug|Ropivacaine|The study group will receive a pump with study drug attached to a catheter placed into the shoulder area by the anesthesiologist.
16058885|NCT02462382|Drug|Saline|The control group will receive a pump with saine attached to a catheter placed into the shoulder area by the anesthesiologist.
16058886|NCT02462369|Drug|Saxagliptin|
16058887|NCT02462369|Drug|glimepiride|
16058888|NCT02462356|Procedure|Uniportal VATS|Uniportal VATS lobectomy and lymph node dissection will be performed in this group
16058889|NCT02462356|Procedure|Conventional VATS|Conventional VATS lobectomy and lymph node dissection will be performed in this group
16058890|NCT02462343|Other|walk tests|
16058893|NCT02462317|Drug|botulinum A toxin|botulinum toxin injection
16058894|NCT02462317|Drug|Baclofen|baclofen oral tablet
16058895|NCT02462317|Drug|Placebo toxin|placebo injection
16058896|NCT02462317|Drug|placebo baclofen|placebo oral tablet
16058897|NCT02462304|Procedure|End-Point-Management grid laser|
16058898|NCT02462304|Drug|ranibizumab|
16058899|NCT02462304|Drug|Bevacizumab|
16058900|NCT02462291|Other|Ecological Environmental therapy|The program of EET consist of the physical interaction (visual, tactile, olfactory) between natural ecological elements such as flowers, trees, grass, and the patients with AD.
16058901|NCT02462278|Device|TempuRing|
16058902|NCT02462265|Drug|Oshadi D & Oshadi R;|Oshadi D (180mg/TID) & Oshadi R (180mg TID) will be administrated;
16058903|NCT02462265|Drug|salvage therapy cytosar and mitoxantrone|Salvage therapy - HAM: Hi dose cytosar (5 or 6 days) and mitoxantrone (2 or 3 days)
16058904|NCT02462252|Drug|BL-8040|Subjects will receive subcutaneous (SC) injections of BL-8040 monotherapy on days 1-10 of the study. Beginning on Month 2 day 1, (M2/D1), and continuing monthly through Month 6, BL-8040 will be administered daily as part of the maintenance period for the first 5 days of each month.
16058905|NCT02462252|Drug|horse anti-thymocyte globulin (hATG)|From Day 11 through Day 14 of first month, subjects will receive hATG infusion over 6-8 hours each day.
16058906|NCT02462252|Drug|Methylprednisolone|From Day 11-14 of first month, subjects receive infusion of methylprednisolone 30 minutes prior to hATG infusion. Treatment with methylprednisolone will continue for 30 days. (After day 14, subjects may receive oral prednisone dose equivalent to IV methylprednisolone dose. The oral dose will be tapered off over 30 days.
16058907|NCT02462252|Drug|Cyclosporine|From Day 11 through end of treatment (Month 6 Day 30), subjects will receive oral dose of cyclosporine.
16058908|NCT02462239|Other|Whole-body FDG PET-CT|
16058909|NCT02462226|Behavioral|The-Optimal-Lymph-Flow|"The-Optimal-Lymph-Flow ™ is a web-based educational and behavioral program focusing on self-care strategies to manage pain and symptoms related to lymphedema. The Optimal Lymph-Flow™ is the only evidence-based self-care program designed to effectively help women treated for breast cancer manage daily pain and symptoms related to lymphedema. Grounded in research-driven behavioral strategies, the program is premised on empowering, rather than inhibiting, how breast cancer survivors live their lives. It emphasizes what to do, rather than what to avoid. It features a safe, feasible and easily-integrated-into-daily-routine of exercises to promote lymph flow and drainage, as well as guidance to maintain an optimal BMI."
16058910|NCT02462226|Behavioral|Arm Precaution|"The webpage also has a section entitled Arm Precautions, representing current patient education that emphasizes precautionary lifestyle behaviors, such as avoidance of repetitive limb movement, lifting weighted objects, needle punctures, blood draw, and the use of compression garments for air travel in the affected limb."
16058911|NCT02462213|Other|Amyloidosis|Patients with amyloidosis without cardiac involvement will undergo cardiac MRI and possible biochemical analysis during the course of the study.
16058912|NCT02462213|Other|Cardiac Amyloidosis|Patients with confirmed cardiac amyloidosis will undergo cardiac MRI and possible biochemical analysis during the course of the study.
16058913|NCT02462200|Procedure|Breast-conserving surgery (BCS)|
16058914|NCT02462200|Procedure|Cavity shave margins (CSM)|
16058915|NCT02462200|Behavioral|BREAST-Q Questionnaire|
16058916|NCT02462200|Device|3-D breast imaging|Using a 3-D breast imaging camera Vectra 3-D XT
16058917|NCT02462200|Other|Indocyanine green|
16058918|NCT02462200|Device|Intraoperative imaging device|The goggle device is wearable, compact, and battery-operated, and it allows for hands-free operation by the wearer. The goggles provide functional information via a NIR light-emitting diode (LED) integrated within one of the eyepieces, which causes NIR fluorescence excitation of the molecular probes within the surgical field
16058919|NCT02462200|Procedure|Peripheral blood draw|-Time of surgery if coordinator is available
16058920|NCT02462187|Drug|NVN1000 8% Gel|once and twice daily
16058921|NCT02462187|Drug|NVN1000 16%|once daily
16058922|NCT02462187|Drug|Vehicle|placebo comparator
16058923|NCT02462187|Drug|NVN1000 24%|once daily
16058924|NCT02462174|Drug|Ketamine|0.5 mg/ kg ketamine with bupivacaine by caudal route after anesthesia and before start of surgery.
16058925|NCT02462174|Drug|Ketamine|0.5 mg/ kg ketamine with bupivacaine will be sprayed around the spermatic cord before wound closure.
16058926|NCT02462174|Drug|Bupivacaine|1 ml/kg bupivacaine 0.25% (maximum volume = 20 ml) by caudal route
16058927|NCT02462174|Drug|Bupivacaine|0.3 ml/kg bupivacaine 0.25% will be sprayed around the spermatic cord before wound closure
16058928|NCT02462161|Drug|Insulin aspart|Participants will administer 20 IU insulin aspart two times per day with an intranasal delivery device.
16058929|NCT02462161|Drug|Placebo|Participants will administer placebo two times per day with an intranasal delivery device.
16058930|NCT02462148|Drug|Dexamethasone|Used in nerve block mixture
16058931|NCT02462148|Drug|Bupivacaine|Used in nerve block mixture
16058932|NCT02462148|Drug|Epinephrine|Used in nerve block mixture
16058933|NCT02462148|Procedure|Saphenous Peripheral Nerve Block|Peripheral nerve block.
16058934|NCT02462135|Behavioral|Virtual interactive memory training|Training sessions of the VIMT group are divided into initial training and booster training. Each training session is 45 minutes/day, 3 sessions/week, for 12 weeks for both initial training and booster training (36 sessions each). The training content of the four memory training include: (1) spatial encoding memory training task, (2) updating-spatial memory training task, (3) updating-visual memory training task, and (4) rehearsal-visuospatial memory training task.
16058935|NCT02462135|Behavioral|Passive information activities|The active control group (Passive information activities) only accepts the initial training phase, which training content of the two types to include: (1) listening to audio books, and (2) reading online newspaper.
16058936|NCT02462122|Drug|IDP-118 Lotion|Lotion
16058937|NCT02462122|Drug|IDP-118 Vehicle Lotion|Lotion
16058938|NCT02462109|Drug|Lorazepam|Lorazepam was given based on the weight of the child with Catatonia. The lower dose (0.5 mg) was used as starting dose for patients with <30 kg body weight, while the higher dose (1 mg) as the starting dose for patients with >30 kg body weight.
16058939|NCT02462096|Device|ReLeaf|The ReLeaf catheter is expected to enable a physician to create tissue leaflets that, in turn, generate a valve effect in the deep veins of the legs.
16058940|NCT02462083|Drug|IDP-118 Lotion|IDP-118 lotion will be applied as per the instructions provided by the investigational center staff.
16058941|NCT02462070|Drug|IDP-118 Lotion|Lotion
16058942|NCT02462070|Drug|IDP-118 Vehicle Lotion|Lotion
16058943|NCT02462057|Other|Email message regarding the HealthyFood benefit|
16058944|NCT02462044|Drug|240 mg Iodine|
16058945|NCT02462044|Drug|300 mg Iodine|
16058946|NCT02462044|Drug|370 mg Iodine|
16058947|NCT02462031|Drug|KD101|200mg, 400mg, 800mg, 1400mg
16058948|NCT02462031|Drug|placebo|200mg, 400mg, 800mg
16058986|NCT02461758|Biological|High dose influenza vaccine (HDIV)|
16059030|NCT02461381|Other|not intervention|This is a cross-sectional study for estimation of diagnostic performance.
16058949|NCT02462018|Device|WalkAide|"Patiants with hemiplegic or asymmetric diplegic CP will use WalkAide device for 4 months .First month for adjustment and three months of daily using of the device.
~For each patient two assessments will be conducted: at baseline and at post-intervention follow-up.
~During the assessments each child will go through:
~A. Medical interview and neurological and physical therapist examination. B. Motor function tests: 6 min walk test, Gross motor function measure (GMFM) ,Timed up and down stairs test (TUDS), walking on a ramp ,with and without the FES device.
~C. Gait analysis test with and without FES device. D. Parents will be requested to complete questionnaires on the frequency of falling.
~E. On the second assessment parents wiil be requested to complete a questionnaire about the compliance to the FES."
16058950|NCT02461992|Drug|Intravenous infusions of Xyntha|A single dose 50IU/kg dose of Xyntha administered by intravenous infusion within 10 minutes on Day 1
16058951|NCT02461979|Other|The VDR genotype|The VDR genotype will determined by polymerase chain reaction (PCR) amplication and restriction length fragment polymorphisms.
16058952|NCT02461966|Other|Aflatoxin|Evaluation of Aflatoxin level
16058953|NCT02461953|Device|hemoperfusion apparatus|
16058954|NCT02461953|Device|low flux dialyzer|
16058955|NCT02461953|Device|high flux dialyzer|
16058956|NCT02461940|Behavioral|Adolescent Behavioral Intervention|Session 1 focuses on STI/HIV education and self-reflection. Session 2 aims to increase the awareness of STI/HIV preventive strategies by instilling condom use and negotiation skills. Motivational Interviewing is used during the behavioural counselling. Session 3 reviews the goal on safer sex set by the participant and examines the successful strategies on safer sex and identifies triggers for relapse. Success stories are shared to renew their motivation. Session 4 reinforces the progress of the participant by recapitulating the knowledge and motivation explored in previous sessions. The online sessions, by phone/SMS/Whatsapp are conducted 2 months after the second and third sessions to find out if they face any difficulties and to reinforce prevention information covered previously.
16058957|NCT02461927|Drug|Ketamine + Naltrexone|Subjects in this arm will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular naltrexone (380 mg) once a month (a total of 2 injections).
16058958|NCT02461927|Drug|Ketamine + Placebo|Subjects in this arm will receive (1) intravenous ketamine (0.5 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular placebo once a month (a total of 2 injections).
16058959|NCT02461927|Drug|Placebo (psychoactive placebo midazolam) + Placebo|Subjects in this arm will receive (1) intravenous psychoactive placebo midazolam (0.045 mg/kg) once a week for 4 weeks (a total of 4 infusions) and (2) intramuscular placebo once a month (a total of 2 injections).
16058960|NCT02461914|Drug|PEX168|200µg,injected subcutaneously,once a week.
16058961|NCT02461914|Drug|Warfarin|5mg,oral,two times.
16058962|NCT02461901|Other|Environmental sampling|Sampling of five sites in the patient's immediate environment for C. difficile spores
16058963|NCT02461901|Other|Skin swab sampling|Collection of swabs from three sites on the skin for C. difficile spores
16058964|NCT02461901|Other|Fecal sampling|Collection of fecal samples for C. difficile spores
16058965|NCT02461888|Drug|Ixazomib|Chemotherapy
16058966|NCT02461888|Drug|Cyclophosphamide|Chemotherapy
16058967|NCT02461888|Drug|Dexamethasone|Chemotherapy
16058968|NCT02461875|Drug|Cabergoline|Patients receive cabergoline 0.5 mg p.o at bed time for 8 days starting on the day of HCG administration.
16058969|NCT02461875|Drug|GnRH antagonist rescue & cabergoline|when the leading follicle reaches 16 mm, HP-uFSH is continued at daily dose of 75 IU/day till the day of HCG administration. Moreover, Gn RH agonist (triptorelin) is discontinued and GnRH antagonist (Cetrorelix acetate)0.25 mg S.C is administered daily till the day of HCG administration. Serum estradiol is measured daily and HCG (5,000 IU/I.M) is administered when serum estradiol level drops below 3500 pg/ml . Moreover, cabergoline 0.5 mg p.o is administered at bed time for 8 days starting on the day of HCG administration.
16058970|NCT02461862|Behavioral|Application of the Visual Analog Scale of pain|Evaluation of pain previous and 5 minutes after outpatient insertion of IUD / IUS using the Visual Analog Scale of Pain
16058971|NCT02461862|Procedure|Evaluation of blood pressure|Evaluation of Blood pressure ( mmHg), previous and 5 minutes after outpatient insertion of IUD / IUS by sphygmomanometer.
16058972|NCT02461862|Procedure|Evaluation of radial pulse|Evaluation of radial pulse (beats per minute) previous and 5 minutes after outpatient insertion of IUD / IUS by pulse oximetry
16058973|NCT02461849|Drug|Imatinib|Imatinib 400mg qd daily
16058974|NCT02461836|Drug|Gemcitabine|Protocol: Gemcitabine 1000mg/m2.body surface area (BSA), IV infusion for at least 30 mins, administered at Day1, Day8, Day15)
16058975|NCT02461836|Radiation|SBRT|Protocol: 5 Gy/d, for 5 consecutive days
16058976|NCT02461823|Device|Zirconia crown|patients will receive a Zirconia crown, the Zirconia crown will cover the natural crown.
16058977|NCT02461823|Device|Porcelain metal crown|patients will receive a porcelain fused to metal crown, the Porcelain metal crown will cover the natural crown.
16058978|NCT02461810|Device|Vertebral fracture surgery SpineJack®|Vertebral augmentation for one osteoporotic vertebral compression fracture
16058979|NCT02461810|Procedure|Balloon Kyphoplasty|
16058980|NCT02461797|Other|healthy controls|biopsy of nasal mucosa for healthy controls
16058981|NCT02461797|Other|AR patients without medication|biopsy of nasal mucosa for allergic rhinitis patients without allergy medication
16058982|NCT02461797|Other|AR patients with use of nasal corticoid spray|biopsy of nasal mucosa for allergic rhinitis patients with use of nasal corticoid spray
16058983|NCT02461784|Procedure|Semen & Data Collection|"If participants decide to participate in this research they will be asked to complete the informed consent process as well as asked a few questions such as age and race/ethnicity. If participants volunteered for this study because tehy have IBD, investigators will also collect some information from the participants medical record. Completing this portion of participation will take less than 1 hour.
~Participants will then be scheduled to complete the semen collection at the UW Health Generations Fertility Clinic located at 2365 Deming Way in Middleton, WI. This collection visit will take less than 1 hour to complete. Once participants have finished the collection visit they will have completed their participation in this research project."
16058984|NCT02461771|Drug|Pegcetacoplan|On treatment day, subjects will be administered a single 100 μL IVT injection of pegcetacoplan at the dose corresponding to their treatment assignment.
16058987|NCT02461745|Drug|ombitasvir, paritaprevir/r, dasabuvir + ribavirin|VIEKIRA PAK (two 12.5/75/50 mg ombitasvir, paritaprevir, ritonavir tablets, and two 250 mg dasabuvir tablets) + RBV (ribavirin tablets) for 12 weeks
16058988|NCT02461745|Drug|ombitasvir, paritaprevir/r, dasabuvir|VIEKIRA PAK (two 12.5/75/50 mg ombitasvir, paritaprevir, ritonavir tablets, and two 250 mg dasabuvir tablets)
16058989|NCT02461732|Behavioral|Treatment for Integrated Posttraumatic Stress and Substance Use (TIPSS)|"Topics covered include:
~drug triggers; antecedents/consequences of drug use; relapse prevention; coping skills; problem thinking; changing problem thinking; lifestyle balance; values; increasing non-drug activities; education on PTSD and trauma/PTSD/substance use associations; discussion and written statement of impact of trauma on beliefs about self, others, world; written account of trauma memory and in-session review and discussion; cognitive exercises and cognitive restructuring regarding trauma-related thoughts; review of any between-session trauma-relevant substance use and cravings"
16058990|NCT02461732|Behavioral|Cognitive-Behavioral Therapy for Substance Dependence|"Topics covered include:
~drug triggers; antecedents/consequences of drug use; relapse prevention; coping skills; problem thinking; changing problem thinking; lifestyle balance; values; increasing non-drug activities"
16058991|NCT02461719|Drug|CYPORIN N EYE DROPS 0.05%(TJCS eye drop)|1 drop twice/day for 12 weeks to both eyes.
16058992|NCT02461719|Drug|Restasis|1 drop twice/day for 12 weeks to both eyes. Invert the unit dose vial a few times to obtain a uniform, white, opaque emulsion before using.
16058993|NCT02461706|Drug|cannabidiol|All subjects will have a dosing titration starting with 25 mg/kg/day and will be titrated weekly as tolerated based on clinical response. All subjects will be clinically evaluated at baseline, once a month for three months and every three months thereafter. In order to ensure safe use at higher doses, patients receiving more than 600 mg of daily CBD will be evaluated at least monthly until they achieve steady state at the final fixed maintenance dose.
16058994|NCT02461706|Other|Blood Test|All subjects will have the following clinical laboratory tests including changes in bone marrow (CBC), liver (AST, ALT), and kidney function (creatinine, electrolytes, BUN) will be assessed at baseline, each month during months 1 to 3, and every 3 months thereafter.
16058995|NCT02461693|Drug|Caffeine|200mg delivered as pill; one-time dose
16058996|NCT02461693|Drug|Placebo|Lactose-based pill; one-time dose
16058997|NCT02461680|Procedure|tangential resection|the tendon's injury is treated with a tangential resection performed with a surgical blade N°11 The shape of the tangential resection was adapted such that the cross-section disappered
16058998|NCT02461680|Procedure|suture|
16058999|NCT02461667|Drug|SRP plus Placebo Gel|After SRP, placebo gel was delivered subgingivally into the pocket
16059000|NCT02461667|Drug|SRP plus Alendronate gel|Alendronate (ALN) After SRP, ALN gel was delivered subgingivally into the pocket
16059001|NCT02461667|Drug|SRP plus Metformin gel|Metformin (MF) After SRP, MF gel was delivered subgingivally into the pocket
16059002|NCT02461654|Other|Disc FX|Disc FX is an innovative system allowing for a safe and effective approach to a damaged disc without injury to the surrounding structures. The procedure consists of three phases: during the first phase, the disc is punctured with a special needle that functions as a working channel. This needle is used to remove part of the degenerate inner tissue. Then, using a radio-frequency probe, the disc is sealed to minimize the risk of repeated herniation. In the final step, the pathological nerves in the back part of the disc are destroyed with the use of radio-frequency.
16059003|NCT02461641|Other|NuShield|NuShield is a sterilized dehydrated amnion chorion membrane patch.
16059004|NCT02461641|Other|Affinity|Affinity is a aseptically produced hypothermically stored amniotic membrane patch.
16059005|NCT02461641|Other|Standard of Care|Standard of Care for this study is defined as sharp debridement, moist wound dressing and offloading of the area using a DARCO shoe.
16059006|NCT02461628|Behavioral|Malaria RDT & conditional voucher for ACT from retail sector|Trained community health volunteers will offer eligible household members free malaria rapid diagnostic tests and a voucher allowing the purchase of a qualified ACT at a reduced fixed price in the retail sector conditional on a positive test
16059007|NCT02461589|Drug|semaglutide|Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen except subjects who received semaglutide flexible dosing.
16059008|NCT02461589|Drug|liraglutide|Administered subcutaneously ( s.c., under the skin) once daily. All subjects will follow a 4-week dose-escalation regimen.
16059009|NCT02461589|Drug|placebo|Administered subcutaneously ( s.c., under the skin) once daily.
16059010|NCT02461576|Device|Xpert HIV-1 VL Assay|in vitro diagnostic test to quantify HIV-1 RNA
16059011|NCT02461563|Drug|200 mg MK-1075|Two 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days
16059012|NCT02461563|Drug|400 mg MK-1075|Four 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days
16059013|NCT02461563|Drug|800 mg MK-1075|Eight 100 mg tablets of MK-1075 administered orally, once daily for 7 consecutive days
16059014|NCT02461550|Device|Irreversible Electroporation Ablation|
16059015|NCT02461537|Drug|HAM|High-dose cytarabine 1 - 3 g/m2 (days 1-3)/Mitoxantrone 20 mg/m2 (days3-5)
16059016|NCT02461537|Drug|LDAC and/or Mitoxantrone|Low-dose cytarabine 20 mg/m2 (days 1-10) and/ or mitoxantrone 10mg/m2 (max 3 doses)
16059017|NCT02461524|Device|Endurant Evo AAA Stent Graft System|
16059018|NCT02461524|Procedure|Endovascular aneurysm repair (EVAR)|
16059019|NCT02461511|Other|Therapeutic Education|participation in a therapeutic education program on diabetes
16059020|NCT02461485|Other|Fermented milk product containing Probiotics|2 pots/day during 28 days
16059021|NCT02461485|Other|Fermented Milk Product containing Probiotics + Fibers C|2 pots/day during 28 days
16059022|NCT02461485|Other|Fermented Milk Product containing Probiotics + Fibers W|2 pots/day during 28 days
16059023|NCT02461485|Other|Non fermented Milk Product|2 pots/day during 28 days
16059024|NCT02461472|Other|not intervention|This is a cross-sectional study, no intervention was performed.
16059025|NCT02461433|Device|Prevena|Prevena Incision Management system
16059026|NCT02461433|Device|Standard Dressing|This involves standard of care dressing including but not limited to gauze.
16059027|NCT02461407|Drug|Anlotinib|Anlotinib p.o. qd
16059028|NCT02461407|Drug|Placebo|Placebo p.o. qd
16059031|NCT02461368|Drug|Glenohumeral triamcinolone injection by anterior approach|Glenohumeral steroid injection is performed under ultrasound-guidance by anterior approach. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 4 mL normal saline, and 3 mL Omnipaque (Iohexol, General Electronics Healthcare).
16059032|NCT02461368|Drug|Glenohumeral triamcinolone injection by posterior approach|Glenohumeral steroid injection is performed under ultrasound-guidance by posterior approach. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 4 mL normal saline, and 3 mL Omnipaque (Iohexol, General Electronics Healthcare).
16059033|NCT02461368|Drug|Glenohumeral lidocaine injection by anterior approach|Glenohumeral steroid injection is performed under ultrasound-guidance by anterior approach. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 4 mL normal saline, and 3 mL Omnipaque (Iohexol, General Electronics Healthcare).
16059034|NCT02461368|Drug|Glenohumeral lidocaine injection by posterior approach|Glenohumeral steroid injection is performed under ultrasound-guidance by posterior approach. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 4 mL normal saline, and 3 mL Omnipaque (Iohexol, General Electronics Healthcare).
16059035|NCT02461368|Drug|Glenohumeral normal saline injection by anterior approach|Glenohumeral steroid injection is performed under ultrasound-guidance by anterior approach. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 4 mL normal saline, and 3 mL Omnipaque (Iohexol, General Electronics Healthcare).
16059036|NCT02461368|Drug|Glenohumeral normal saline injection by posterior approach|Glenohumeral steroid injection is performed under ultrasound-guidance by posterior approach. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 4 mL normal saline, and 3 mL Omnipaque (Iohexol, General Electronics Healthcare).
16059037|NCT02461368|Drug|Glenohumeral Omnipaque injection by anterior approach|Glenohumeral steroid injection is performed under ultrasound-guidance by anterior approach. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 4 mL normal saline, and 3 mL Omnipaque (Iohexol, General Electronics Healthcare).
16059038|NCT02461368|Drug|Glenohumeral Omnipaque injection by posterior approach|Glenohumeral steroid injection is performed under ultrasound-guidance by posterior approach. The injection mixture was: 1 mL triamcinolone, 4 mL lidocaine, 4 mL normal saline, and 3 mL Omnipaque (Iohexol, General Electronics Healthcare).
16059039|NCT02461355|Behavioral|Aphasia therapy|Aphasia therapy using a computerized scripting program
16059040|NCT02461355|Device|Anodal tDCS|Anodal transcranial direct current stimulation using the Chattanooga Ionto device
16059041|NCT02461355|Device|Sham tDCS|Sham transcranial direct current stimulation using the Chattanooga Ionto device
16059042|NCT02461342|Other|not intervention|This is a cross-sectional study, no intervention was performed.
16059043|NCT02461329|Drug|Gelofusine® B. Braun|Volume therapy by Gelatine solution infusion via intravenous boluses to achieve hemodynamic targets
16059044|NCT02461329|Drug|Ringerfundin ® B. Braun|Volume therapy by Balanced Crystaloid solution solution infusion via intravenous boluses to achieve hemodynamic targets
16059045|NCT02461316|Other|No intervention|No intervention administered in this study: Rituximab in combination with fludarabine and cyclophosphamide for 6 months according to registered indication.
16059046|NCT02461303|Other|Counseling|Subjects will be counseled on the impact of KS on the reduced fertility potential, and about providing a semen sample for semen analysis. Semen analysis is the gold standard for fertility preservation in adult patients, but is only rarely considered by post-pubertal adolescent and young adult patients and their families. Only the semen analysis parameters will be used by the study for the comparison with physical and endocrine measures to assess whether spermatogenesis in these patients coincides with pubertal development. All potential frozen samples will be stored for the patient's future use, and samples will not be used for research experiments.
16059047|NCT02461290|Radiation|Chemotherapy|
16059048|NCT02461290|Drug|Rituximab|
16059049|NCT02461277|Other|Fast-track protocol|Preoperatory management, epidural anesthetic management, avoiding the need opioid in postoperatory analgesia and use of an standardized postoperatory management protocol to an early oral intake and early mobilization. At the postoperative recovery room, after extubation and fully awake, patients started physiotherapy exercises, as physical exercises of moving up upper and lower extremities accompanied by deep breathing exercises. After than, the patients standed up beside the bed and if there was no complications, patients performed ambulation. The physiotherapist aided the patients during all period.
16059050|NCT02461264|Drug|Single red blood packed cells Transfusion|
16059051|NCT02461264|Drug|Two packed red blood cells Transfusion|
16059052|NCT02461251|Device|Rotational Thromboelastometry (ROTEM)|A Point-of-care blood coagulation test tool is used to guide the treatment of major obstetric bleeding.
16059053|NCT02461238|Other|Vouchers|The vouchers sent to families can be used in supermarkets for fresh, frozen or canned fruits and vegetables, excluding potatoes. The amount of the vouchers takes into account family composition, calculated to correspond to a serving per day per person.
16059054|NCT02461238|Other|Nutrition education|Nutrition education workshops taught by a dietician
16059055|NCT02461225|Device|Erchonia® FX-635™|The Erchonia® FX-635™ is made up of 3 independent 17 mW, 635 nm red laser diodes that are applied for 15 minutes to each foot. The diodes are positioned around the foot such that each of the 3 laser lights is positioned between 3 and 4 inches away from, but directed toward: a) the top of the foot (dorsal aspect); b) the bottom of the foot (plantar aspect); and c) the posterior tibial nerve within the tarsal tunnel. The laser diodes laze each of these 3 areas for 15 minutes simultaneously. Each subject receives 12 total procedure administrations with the Erchonia® FX-635™ across the consecutive 6-week procedure administration phase, 2 procedure administrations per week, each procedure administration approximately evenly spaced.
16059056|NCT02461225|Device|Placebo Laser|The Placebo Laser has the same appearance as the Erchonia® FX-635™ but does not emit any therapeutic light. It is applied for 15 minutes to each foot. The diodes are positioned around the foot such that each of the 3 laser lights is positioned between 3 and 4 inches away from, but directed toward: a) the top of the foot (dorsal aspect); b) the bottom of the foot (plantar aspect); and c) the posterior tibial nerve within the tarsal tunnel. The laser diodes laze each of these 3 areas for 15 minutes simultaneously. Each subject receives 12 total procedure administrations with the Erchonia® FX-635™ across the consecutive 6-week procedure administration phase, 2 procedure administrations per week, each procedure administration approximately evenly spaced.
16059175|NCT02460445|Drug|Cyproterone Acetate|2 mg cyproterone acetate qd for 21 days per month as usual clinical practice.
16059057|NCT02461225|Device|Erchonia® FX-635™ Placebo Cross-over|The Erchonia® FX-635™ is made up of 3 independent 17 mW, 635 nm red laser diodes that are applied for 15 minutes to each foot. The diodes are positioned around the foot such that each of the 3 laser lights is positioned between 3 and 4 inches away from, but directed toward: a) the top of the foot (dorsal aspect); b) the bottom of the foot (plantar aspect); and c) the posterior tibial nerve within the tarsal tunnel. The laser diodes laze each of these 3 areas for 15 minutes simultaneously. Each subject receives 12 total procedure administrations with the Erchonia® FX-635™ across the consecutive 6-week procedure administration phase, 2 procedure administrations per week, each procedure administration approximately evenly spaced.
16059058|NCT02461212|Procedure|Magnetic Resonance Imaging (MRI)|A MRI scan which will include magnetic resonance spectroscopy (MRS) of the liver to determine hepatic triglyceride content, a hepafat scan to measure volume fraction of fat in liver tissue, and a MRI for detection of liver fibrosis. The scan will last approximately 15 minutes.
16059059|NCT02461199|Biological|Fecal microbiota transplantation|Transplantation of 100 ml of fecal microbiota suspension obtained from healthy unrelated donor in two consecutive days via the nasoduodenal tube
16059060|NCT02461186|Drug|Arterolane maleate-piperaquine phosphate (Synriam)|
16059061|NCT02461186|Drug|Dihydroartemisinin-piperaquine phosphate (Duocotexin)|
16059062|NCT02461173|Drug|Merional|On the 3rd day of menstruation women will have a vaginal ultrasound and will receive daily intramuscular 150 IU of human menopausal gonadotropins (hMG, Merional ®, IBSA, Lugano, Switzerland) starting from the 3nd day of menstruation.
16059063|NCT02461173|Procedure|IUI|Semen will be processed and drawn into a shepherd catheter attached to a 1 mL syringe and injected into the uterus
16059064|NCT02461173|Procedure|Ovulation detection|Women will be asked to test their morning urine specimen for luteinizing hormone daily starting 4 days before the expected day of ovulation. This will be done using a qualitative kit
16059065|NCT02461173|Drug|Choriomon|Administration of 10000 IU of human chorionic gonadotropin (hCG; Choriomon®, IBSA) when at least 2 follicles measuring 18 mm are observed during vaginal ultrasound and is associated with serum E2 of 500-3000 Pg/mL
16059066|NCT02461173|Device|shepherd catheter|
16059067|NCT02461160|Drug|TAK-915 suspension|TAK-915 oral suspension
16059068|NCT02461160|Drug|Midazolam|Midazolam oral solution
16059069|NCT02461160|Drug|Placebo|Placebo-matching TAK-915 suspension
16059070|NCT02461160|Drug|TAK-915 tablet|TAK-915 tablet
16059071|NCT02461147|Procedure|Cholecystectomy with intraoperative cholangiogram|cf. arm/group description. This intervention is not assigned by the investigators: it is the standard treatment at the investigators institution.
16059072|NCT02461134|Drug|Ponesimod|Oral film-coated tablets at the doses of 2, 3, 4, 5, 6, 7, 8, 9, 10, and 20 mg. One tablet of ponesimod at any dose will be taken orally once daily.
16059073|NCT02461121|Genetic|HLA mismatched stem cell|HLA mismatched donor G-CSF mobilized peripheral stem cell infused 24 hours (day 0) after the completion of chemotherapy
16059074|NCT02461121|Genetic|HLA matched stem cell|HLA matched donor G-CSF mobilized peripheral stem cell infused after the conditioning reginmen
16059075|NCT02461121|Drug|cyclosporine A|The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil
16059076|NCT02461121|Drug|Mycophenolate mofetil|The GVHD prophylaxis included cyclosporine A and mycophenolate mofetil
16059077|NCT02461121|Drug|Ara-C|2.0 to 3.0g/m2 per 12 hours intravenously for 6 dose
16059078|NCT02461121|Drug|fludarabine|30 mg/m2/d for 5days
16059079|NCT02461121|Drug|anti-lymphocyte globulin|1.5-2 mg/kg/d for 4 days
16059080|NCT02461121|Drug|cyclophosphamide|40 mg/kg/d for 2 days
16059081|NCT02461108|Behavioral|Subsidy|Frame the price difference as a 10% subsidy on nutritious food items.
16059082|NCT02461108|Behavioral|Tax|Frame the price difference as a 10% tax on less nutritious food items.
16059083|NCT02461108|Behavioral|Tax and subsidy|Frame the price difference as a 5% tax on less nutritious food items and a 5% subsidy on nutritious food items, creating a 10% relative price difference between the types of foods.
16059084|NCT02461095|Other|Impairment based approach|This intervention will consist of exercise, mechanics training, education, manual therapy and modalities. The treatment will address the impairments found during the evaluation. This approach is a typical individualized physical therapy treatment approach.
16059085|NCT02461095|Other|PFPS Algorithm approach|Physical Therapy treatment for Patellofemoral Pain Syndrome based upon a treatment algorithm that addresses patients: fear avoidance beliefs, flexibility, body mechanics, and strength. The exercises and treatments are individualized to each patient with the goals of low fear avoidance beliefs, flexibility, body mechanics, and strength and are performed in a sequential manner
16059086|NCT02461082|Device|Expiratory muscle strength training (EMST)|The EMST is performed 4 weeks, 5 days per week, for 20 minutes per day, using a calibrated or sham, handheld device (EMST 150, Aspire Products, Gainesville, FL).
16059087|NCT02461082|Other|Transcranial magnetic stimulation (TMS)|A sham or active transcranial magnetic stimulation is performed at the last 5 days of EMST training.
16059088|NCT02461069|Drug|Dimethyl fumarate|Dimethyl fumarate (Tecfidera®) treatment is initiated by daily administration of 120 mg Tecfidera® p.o. in the morning in week 0. At week 1, the dose is increased to 120 mg Tecfidera® p.o. twice daily, split into a morning and an evening dose. At week 2, the daily dose is further increased to 240 mg Tecfidera® p.o. in the morning and 120 mg Tecfidera® p.o. in the evening. Finally at week 3, the dose will be increased to the final daily dose of 240 mg Tecfidera® p.o. in the morning and 240 mg Tecfidera® p.o. in the evening and maintained throughout the study.
16059089|NCT02461056|Drug|Ibuprofen|Drug was administered by the Dixon and Mood up-and-down method. Starting doses was ibuprofen 50 mg. The maximum doses was ibuprofen 800 mg. Combination index (CI) (additive: 0.9-1.1, synergism: <0.9, antagonism: >1.1), dose reduction index (DRI, a measure of how much the dose of each drug in a combination can be reduced), and isobologram were used to define the nature of their interaction.
16059090|NCT02461056|Drug|Hydromorphone|Drug was administered by the Dixon and Mood up-and-down method. Starting doses was hydromorphone 0.25 mg. The maximum doses was hydromorphone 2 mg. Combination index (CI) (additive: 0.9-1.1, synergism: <0.9, antagonism: >1.1), dose reduction index (DRI, a measure of how much the dose of each drug in a combination can be reduced), and isobologram were used to define the nature of their interaction.
16059932|NCT02455050|Drug|Systane® Gel Drops|1 to 2 drops of Systane® Gel Drops in each eye.
16059091|NCT02461043|Drug|paclitaxel; cisplatin|The adjuvant chemotherapy regimen consisted of paclitaxel 150mg/m2 intravenously (IV) over 3 hours on day 1, followed by cisplatin 50mg/m2 IV on day 2 every 14 days for 4 to 6 cycles.
16059092|NCT02461043|Radiation|radiation|radiation
16059093|NCT02461030|Drug|In-office and at home Colgate sensitive pro-relief - CSPR|Prophylaxis with rubber cup using In-office Colgate sensitive pro-relief (CSPR), after non-surgical periodontal therapy, and tooth brushing with at home CSPR toothpaste.
16059094|NCT02461030|Drug|In-office Villevie® prophy paste + Colgate Toothpaste|Prophylaxis with rubber cup using In-office Villevie® (fluoride-free) prophy paste + Colgate Toothpaste, after non-surgical periodontal therapy.
16059095|NCT02461030|Procedure|Non-surgical periodontal treatment|Full-mouth debridment, scaling and root planing with ultrasonic/hand instruments
16059096|NCT02461017|Other|Assess for Audible Endotracheal Leak|In supine position, the head will be positioned in neutral position. With fresh gas flow at 2-5L/min, and pop off valve in the anesthesia machine closed and pressure in the inspiratory circuit is slowly increased until an audible leak is heard at the mouth. That pressure will be recorded.
16059097|NCT02461017|Other|Assess for Endotracheal Leak with direct visualization under rigid bronchoscope|In the same patient position, a flexible nasal laryngoscope will be inserted and positioned superior to the laryngeal inlet by the surgeon. With fresh gas flow at 2-5L/min, and pop off valve in the anesthesia machine closed, the pressure in the inspiratory circuit will be increased slowly until a leak around the TT will be visualized by inspecting the supraglottic area for bubbles or air movement around the TT. The peak pressure at which leak is observed physically will be recorded. This is the end of the study.
16059098|NCT02461004|Drug|CKD-391|Investigational product is prescribed to all of radomized subjects for two times.
16059099|NCT02461004|Drug|Atrovastatin and Ezetimibe combination therapy|Investigational products are prescribed to all of radomized subjects for two times.
16059100|NCT02460991|Device|DEB-TACE|
16059101|NCT02460991|Drug|Sorafenib|
16059102|NCT02460978|Drug|Dapagliflozin|Tablets
16059103|NCT02460978|Other|Placebo for dapagliflozin|Tablets
16059104|NCT02460926|Procedure|Scaling & Root Planing|It consists in the non-surgical debridement of the sub gingival area affected by periodontal disease
16059105|NCT02460913|Procedure|Acupuncture|Acupuncture session of 20 to 30 minutes. Treatment protocols were determined through review of major clinical manuals and textbooks, literature review, and a panel of specialist acupuncturists from Chinese medicine backgrounds.
16059106|NCT02460913|Drug|Morphine titration|Patients in this group received IV titrated morphine. Morphine was prepared onsite and diluted in a manner to obtain a dose of 1mg in each ml of normal saline. The initial dose was 0.1 mg per kg and a titration dose of 0.05 mg per Kg was repeated every 5 minutes until reaching objective. The maximum allowed dose was 1.5 mg/kg.
16059107|NCT02460900|Drug|Varenicline|
16059108|NCT02460900|Behavioral|Positively Smoke Free|
16059109|NCT02460900|Drug|Placebo|
16059110|NCT02460900|Behavioral|Standard of Care|
16059111|NCT02460887|Drug|Gemcitabine|Experimental arm: Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 2 cycles before IMRT.
16059112|NCT02460887|Drug|cisplatin|Experimental arm: Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 2 cycles before IMRT.
16059113|NCT02460887|Drug|cisplatin|Active Comparator arm: Patients receive weekly cisplatin 40 mg/m² up to 7cycles during IMRT.
16059114|NCT02460887|Radiation|Intensity-modulated Radiotherapy|Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.33 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor.
16059115|NCT02460874|Drug|Glyburide|1.25mg, twice a day
16059116|NCT02460874|Other|Placebo|1.25mg, twice a day
16059117|NCT02460861|Procedure|biopsies of the prostatic fossa in Magdeburg|intraoperative Open surgical biopsies of the prostatic fossa after prostatevesiculectomy in Magdeburg
16059118|NCT02460861|Procedure|RPVE|Open Radical prostatovesiculectomy in Magdeburg
16059119|NCT02460861|Procedure|ETRARP|Robotassisted Radical prostatovesiculectomy in Gronau
16059120|NCT02460861|Procedure|CE|Open cystectomy in Magdeburg/Gronau
16059121|NCT02460861|Procedure|biopsies of the prostatic fossa in gronau|intraoperative endoscopic robotassisted biopsies of the prostatic fossa after prostatevesiculectomy in Gronau
16059122|NCT02460848|Other|Outpatient therapeutic program, counseling and cash transfer|"Each household will receive an unconditional cash transfer of $40 value every month during a 6 months' period.
~The amount of cash per household per month was defined according to the results of the Household Economy Approach survey. This amount represents 70% of supplement to the monthly average household income characterized as very poor to meet their basic needs. This threshold corresponds to the total of food and income necessary to cover 100% of energy needs food (2100 kcal per day per person), the costs associated with the preparation and consumption of food (e.g. salt, soap, kerosene and / or firewood for cooking and basic lighting) and finally all expenses for access to water for human consumption."
16059123|NCT02460848|Other|Outpatient therapeutic program and counseling|
16059124|NCT02460835|Radiation|Adaptive Radiation Therapy|
16059125|NCT02460822|Device|MyChemoCare iPad application|
16059126|NCT02460809|Device|Transcranial direct current stimulation (tDCS)|Transcranial direct current stimulation (tDCS) uses two surface electrodes placed on the scalp. These electrodes pass a low voltage current and modulate membrane potentials of underlying neurons.
16059127|NCT02460796|Other|Hippotherapy|The sessions began with a 5 minutes warm up that involved stretching and body awareness exercises. Then, the training was conducted for 20 minutes with arms and torso exercises, changes of direction called serpentine movements; up and down hip movements with feet on stirrups, and forced expiration. In the final 5 minutes, exercises for relaxation were conducted with the horse which involved moving the hand on the horse's neck, laying forward on the head and stroking the horse. The horses walking speed was between 5.8 and 6.4 Km/h.
16059128|NCT02460783|Other|Boost 5-2 diet|Regular diet for 5 days/week; Calorie Restriction (480 Kcal in the form of a shake) for 2 days /week. Supplement providing 240 Kcal per shake. Participant takes 2 shakes per calorie restriction day.
16059129|NCT02460783|Other|Healthy Living Diet|Counseling and educational material on diet portion, consistency
16061799|NCT02441946|Drug|Loperamide|Administered orally
16059130|NCT02460770|Drug|Autologous mesenchymal stem cells|After bone-marrow aspiration by an authorized person, mesenchymal stem cells were isolated and cultured during 17 days by the French Blood Establishment. Then, patients receive intramyocardial injections of mesenchymal stem cells during device surgery.
16059131|NCT02460757|Other|Laryngoscopy|Observation of glottic width in different arms
16059132|NCT02460744|Radiation|Hypofractionation|Radiation dose of 34Gy in 10 fractions over 2 weeks.
16059133|NCT02460731|Biological|Fresh Frozen Plasma|Fresh Frozen Plasma [young (<30 years of age) healthy male donors] Solution for intravenous infusion
16059134|NCT02460718|Behavioral|ENCOURAGE Study|This intervention tested the effects of a peer coaching program plus brief diabetes education versus brief diabetes education alone on diabetes outcomes.
16059135|NCT02460705|Drug|Biologically active human fecal material, OpenBiome|Fecal microbiota transplant
16059136|NCT02460692|Drug|Placebos|Administration of vaporized cannabis plus either dronabinol or placebo pill
16059137|NCT02460692|Drug|dronabinol|Administration of vaporized cannabis plus either dronabinol or placebo pill
16059138|NCT02460692|Drug|Vaporized Cannabis 3.7% THC/5.6% CBD|Administration of vaporized cannabis plus either dronabinol or placebo pill
16059139|NCT02460679|Drug|EPI-589|An immediate release film-coated table at a 250 mg dosage strength will be administered per dose and schedule specified in arm.
16059140|NCT02460666|Behavioral|Tai-Chi-Chih (TCC)|
16059141|NCT02460666|Behavioral|Health Education and Wellness Classes (HEW)|
16059142|NCT02460653|Device|HFNC Flow Rate|We only change the flow rates between low, medium and high settings.
16059143|NCT02460640|Procedure|Tap block|intravenous patient-controlled analgesia with morphine and tap block with subcostal and posterior approach with ropivacaine 0,5% 15ml+15ml
16059144|NCT02460640|Procedure|intravenous Patient controlled analgesia|intravenous patient-controlled analgesia with morphine
16059145|NCT02460640|Drug|Morphine|
16059146|NCT02460640|Drug|Ropivacaine|
16059147|NCT02460627|Drug|Lidocaine adhesive tape|700 mg for 12 hours
16059148|NCT02460627|Other|Adhesive tape|For 12 hours
16059149|NCT02460614|Procedure|Rhinopharyngeal clearance|At the end of the expiratory time, the child's mouth was closed by the hand of the researcher (raising the lower jaw), leading the child to perform a nasal aspiration maneuver.
16059150|NCT02460614|Procedure|Aspiration|A sterile aspiration catheter was connected to an extension and carefully introduced into the nasal cavity of the patient.
16059151|NCT02460614|Other|0.9% saline|0.9% saline consists of physiological solution and was instilled in both experimental groups.
16059152|NCT02460601|Drug|Qizhiweitong granule|
16059153|NCT02460588|Drug|Cyclophosphamide|"Population is IPF patients with an AE who meet the inclusion and exclusion criteria defined below.
~Intravenous Cyclophosphamide (CYC), 600 mg/m² (adapted to age and renal function, maximal dose of 1.2 g) at Day 0, Day 15, M1, M2"
16059154|NCT02460588|Drug|Placebo|Population is IPF patients with an AE who meet the inclusion and exclusion criteria defined below.
16059155|NCT02460588|Drug|Corticosteroid (prednisolone)|All patients will receive non experimental medication with high dose of corticosteroid.
16059156|NCT02460575|Biological|Lactobacillus reuteri 17938|probiotic
16059157|NCT02460575|Biological|Placebo|Composition Sunflower oil, medium chain triglyceride oil and silicon dioxide. Total viable count of L. reuteri is zero CFU/ 5 drops.
16059158|NCT02460562|Device|S-PRG filler|"Surface pre-reacted glass-ionomer (S-PRG) filler is a new type of biological material. This new material is being used in the formulation of dental product as filling materials. It has an anti-plaque effect which will release ions to alter the pH of the surrounding environment when it comes into contact with water or acidic solutions. These ions will exert their effect on caries prevention.
~The amount of S-PRG filler that is put in the standard resin denture base is 20% by weight. They are incorporated into the resin denture base and maintain the mechanical properties as required by ISO 1567."
16059159|NCT02460562|Device|PMMA resin|Polymethyl methacrylate (PMMA) resins have been used for the fabrication of resin denture base for 50 years. The advantages of PMMA resin that most notably is the ease of fabrication with very simple equipment but a limitation is the fragility because of its physical properties that include low flexural strength and surface hardness.
16059160|NCT02460549|Behavioral|therapeutic education program|
16059161|NCT02460536|Behavioral|Attention Bias Modification treatment (ABMT)|Attention training via repeated trials of a dot-probe task intended to direct attention away from threat stimuli using threat and neutral face stimuli.
16059162|NCT02460536|Behavioral|Exposure only +ABMT|Identical discrimination task including exposure to a single threat or neutral face stimulus in each trial.
16059163|NCT02460536|Behavioral|Attention training only +ABMT|Attention training via repeated trials of a dot-probe task using non-emotional stimuli.
16059164|NCT02460536|Behavioral|Placebo group|Identical discrimination task including a single non-emotional stimulus in each trial.
16059165|NCT02460523|Procedure|conservative|1- Patients in conservative treatment group will receive medical treatment in the form of antibiotics (3rd generation cephalosporine), analgesics (NSAID eg Ibuprofen) and antispasmodics for 3 days. These patients will be followed up for improvement on the ground of clinical symptoms and serum bilirubin level and abdominal US for CBD stones.
16059166|NCT02460523|Procedure|ERCP|2- Patients in ERCP group will undergo ERCP and wide papillotomy and stone extraction directly then laparoscopic cholecystectomy (LC) within 3 days.
16059167|NCT02460510|Drug|Mannitol|
16059168|NCT02460510|Drug|3% hypertonic saline|
16059169|NCT02460497|Drug|Treatment: Minoxidil 2% / Botanical Hair Solution for Women|
16059170|NCT02460484|Biological|Autologous Cord Blood Infusion|Intravenous infusion
16059171|NCT02460471|Radiation|palliative radiation therapy|thermoplastic mask immobilization. CT in treatment position. radiation dose of 25 Gy in 5 daily fractions over one week 6 MV photons by intensity modulation. Target volume is the symptomatic tumour volume with a 5 mm margin
16059172|NCT02460458|Drug|Von Willebrand Factor|Replacement therapy with plasma-derived and/or recombinant VWF concentrates on-demand or under prophylaxis therapeutic scheme.
16059173|NCT02460445|Procedure|Phlebotomy|Scheduled standard phlebotomy every three months from month 3 to 12 of follow-up.
16059174|NCT02460445|Drug|ethinylestradiol|35 mcg ethinylestradiol qd for 21 days per month as usual clinical practice.
16059176|NCT02460432|Device|Paclitaxel-eluting metal Stent|Insertion of Niti-S Mira-Cover III Biliary Stent using ERCP
16059177|NCT02460432|Device|Covered Metal Stent|Insertion of ComVi Biliary Covered Stent using ERCP
16059178|NCT02460419|Drug|capecitabine|capecitabine 1250mg/m2 bid, oral, for 14 days, every 3 weeks. Number of Cycles: until progression or unacceptable toxicity develops.
16059179|NCT02460419|Other|Best supportive care (BSC)|Best supportive care and following-up every 6-8 weeks
16059180|NCT02460406|Other|traditional physiotherapy|We are applying routine traditional physiotherapy consisted of neurodevelopmental treatment (stretching, weight bearing, functional reaching & walking so on).
16059181|NCT02460406|Other|progressive functional strength training|"Participants allocated to the experimental group completed three times a week, 12-week progressive resistance training protocol. This protocol consisted of functional squat system with virtual reality in leg press, plyometric exercises, exercises with Bosu ball & heel-rise exercises. This intensity of training is approximately equal to training at an intensity of 60% to 80% of one-repetition maximum according to National Strength and Conditioning Association (NSCA) protocols. Intensity of exercise is gradually increased 10% bi-weekly."
16059182|NCT02460393|Drug|Humanized TNFα monoclonal antibody|"Subcutaneous injection of different doses for healthy people
~Subcutaneous injection of different doses in healthy people"
16059183|NCT02460393|Other|placebo|Subcutaneous injection of different doses for healthy people
16059184|NCT02460380|Drug|Vitamin D3|Women allocated to vitamin D arm received one capsule 50.000 IU of vitamin D3 once weekly for eight weeks.
16059185|NCT02460380|Other|Placebo|Women in the placebo arm received once capsule of placebo once weekly for eight weeks
16059186|NCT02460367|Drug|Docetaxel|
16059187|NCT02460367|Biological|Tergenpumatucel-L|
16059188|NCT02460367|Drug|Indoximod|
16059189|NCT02460354|Drug|Metformin|Metformin 500 mg pill dispensed once orally
16059190|NCT02460341|Drug|ondansetron|Ondansetron 8mg, 16mg, 24mg
16059191|NCT02460341|Drug|placebo|placebo pill
16059192|NCT02460315|Procedure|early cholecystectomy|Those patients are primarily managed by endoscopic sphincterotomy and stone extraction for management of CBD stones. Then, the study population will be divided into 2 groups; group 1 will be managed by early laparoscopic cholecystectomy (LC) within 3 days after ERCP
16059193|NCT02460315|Procedure|late cholecystectomy|Those patients are primarily managed by endoscopic sphincterotomy and stone extraction for management of CBD stones. Then, the study population will be divided into 2 groups; group 2 will be managed by late LC one month after ERCP.
16059194|NCT02460302|Drug|Vaginal progesterone|Micronized vaginal progesterone 100mg inserted vaginally
16059195|NCT02460302|Drug|Placebo|Placebo suppository inserted vaginally
16059196|NCT02460289|Drug|Treatment: Minoxidil 5% / Botanical Hair Solution for Men|
16059197|NCT02460276|Drug|Lenalidomide|
16059198|NCT02460276|Drug|Ibrutinib|
16059199|NCT02460276|Drug|Rituximab|
16059200|NCT02460263|Device|Tablo Hemodialysis System|
16059201|NCT02460250|Procedure|Fibroscan|All included patients will undergo a Fibroscan (either Fibroscan Touch model or 402 model which enable CAPTM data extraction) once all eligibility criteria have been checked.
16059202|NCT02460237|Procedure|Disease Screening|Complete HPV self-test
16059203|NCT02460237|Other|Educational Intervention|Receive culturally appropriate instructions for using and returning the HPV self-test device and a photo story information sheet about HPV and HPV self-testing
16059204|NCT02460237|Other|Informational Intervention|Receive standard instructions and information sheet
16059205|NCT02460237|Other|Laboratory Biomarker Analysis|Correlative studies
16059206|NCT02460237|Other|Survey Administration|Ancillary studies
16059207|NCT02460224|Drug|LAG525|study drug 1
16059208|NCT02460224|Drug|PDR001|study drug 2
16059209|NCT02460211|Dietary Supplement|Vitamin D3|Those randomized to the treatment arm will receive three 50,000 unit oral doses of vitamin D3 supplementation. The first dose will be given the evening before surgery. The second and third doses will be given either orally or per NG tube on days 1 and 2 after surgery.
16059210|NCT02460211|Dietary Supplement|Placebo|Those randomized to the control arm will receive three placebo doses. The first dose will be given the evening before surgery. The second and third doses will be given either orally or per NG tube on days 1 and 2 after surgery.
16059211|NCT02460198|Biological|Pembrolizumab|IV infusion
16059212|NCT02460185|Behavioral|Study group: Maternal Physical Exercise|Exercise: 30 minutes of walking, 3 times a week at 4 Km/h.
16059213|NCT02460172|Device|Zip Surgical Skin Closure|Non invasive, reversible, skin closure device for closure of the skin layer following surgical incisions or laceration repair.
16059214|NCT02460172|Device|Steel Staples|Skin closure device for the closure of the skin layer following surgical incision
16059215|NCT02460159|Drug|EZ 10 mg/Atorva 20 mg FDC|
16059216|NCT02460159|Drug|EZ 10 mg/Atorva 10 mg FDC|
16059217|NCT02460146|Drug|CXA-10|CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitrated oleic acid
16059218|NCT02460146|Other|CXA-10 placebo|The placebo contains olive oil with BHT (0.08% to 0.10%).
16059219|NCT02460133|Drug|Paritaprevir|
16059220|NCT02460133|Drug|Ritonavir|
16059221|NCT02460133|Drug|Dasabuvir|
16059222|NCT02460133|Drug|Ombitasvir|
16059223|NCT02460133|Drug|Ribavirin|In genotype 1b individuals without cirrhosis, treatment will NOT include ribavirin.
16059224|NCT02460120|Device|Archimedes System|The Archimedes System is an image-guided navigation system used to access tissue samples in the lungs
16059225|NCT02460107|Biological|Botulinum toxin type A|
16059226|NCT02460107|Other|Normal saline|Placebo
16059227|NCT02460094|Drug|BIIB092|See Arm Descriptions for dosing information.
16059228|NCT02460094|Drug|Placebo|See Arm Descriptions for dosing information. (0.9% Sodium Chloride for Injection or 5% Dextrose Injection if Sodium Chloride is not available)
16059229|NCT02460081|Drug|PDA-002|
16059230|NCT02460081|Drug|Placebo|
16059231|NCT02460068|Drug|Fotemustine|Fotemustine: fotemustine at 100 mg/mq intravenously (i.v.) over 60 minutes once every week for 3 doses, and once every 3 weeks from week 9 for 6 doses.
16059934|NCT02455037|Other|Neck Strengthening|Targeted neck strengthening exercises
16059232|NCT02460068|Drug|Fotemustine and Ipilimumab|Fotemustine and ipilimumab:fotemustine 100 mg/m2 i.v. over 60 minutes once every week for 3 weeks (Weeks 1, 2, 3) plus ipilimumab at 10 mg/kg i.v. over 90 minutes every 3 weeks for 4 cycles (Weeks 1, 4, 7, 10); fotemustine 100 mg/m2 i.v. over 60 minutes once every 3 weeks from week 9 for 6 doses plus ipilimumab at 10 mg/kg i.v. over 90 minutes every 12 weeks from week 24.
16059233|NCT02460068|Drug|Ipilimumab and nivolumab|ipilimumab and nivolumab: ipilimumab 3 mg/kg i.v over 90 minutes combined with nivolumab 1 mg/kg i.v over 60 minutes every three weeks for 4 doses, then nivolumab 3 mg/kg IV over 60 minutes every two weeks.
16059234|NCT02460055|Device|endotracheal tube|This study will determine if the placement of an ETT will lead to dysphagia.
16059235|NCT02460055|Drug|propofol|propofol 3mg/kg will be administered to facilitate endotracheal intubation
16059236|NCT02460055|Drug|Fentanyl|Fentanyl 1mcg/kg will be administered to facilitate endotracheal intubation
16059237|NCT02460055|Drug|Dexamethasone|Dexamethasone 0.15mg/kg up to 20 mg will be used for anti-emesis prophylaxis
16059238|NCT02460055|Drug|Ondansetron|Ondansetron 0.15mg/kg up to 4mg will be used for anti-emesis prophylaxis
16059239|NCT02460055|Drug|sevoflurane, nitrous oxide and oxygen|Inhalational agents will be used to induce general anesthesia
16059240|NCT02460042|Procedure|drug coated balloon angioplasty|percutaneous transluminal angioplasty with peripheral balloon catheters
16059241|NCT02460042|Device|SeQuent® Please OTW Paclitaxel Coated Balloon Catheter|
16059242|NCT02460029|Other|Ventral hernia|Visualization of the mesh surface and the confirmation with MRI scan at 1 month and 13 months after standardized retromusculare incisional hernia repair with the visible CICAT mesh (Dynamesh®).
16059243|NCT02460016|Drug|AK0529|AK0529 pellets for oral administration
16059244|NCT02460003|Behavioral|Physiotherapy|A program of physiotherapy including manual therapy, exercise, pain education.
16059245|NCT02460003|Other|Home exercise program|Home exercise program
16059246|NCT02459977|Drug|Basiliximab|Basiliximab induction therapy
16059247|NCT02459977|Drug|No basiliximab|No basiliximab induction therapy
16059248|NCT02459977|Procedure|Kidney transplantation|kidney transplantation
16059249|NCT02459964|Drug|Fentanyl Nasal Spray|Fentanyl nasal spray 100 mcg delivered at time 0 (defined as the time when intranasal Fentanyl spray is administered) with a rescue dose allowed at time 0.5 hour (h)
16059250|NCT02459964|Drug|Hydromorphone Hydrochloride|Hydromorphone hydrochloride 1.5 mg pushed intravenously (IV) at time 0 (defined as the time of completion of opioid IV push) with a rescue dose allowed at time 0.5 hour (h).
16059251|NCT02459964|Behavioral|Phone Call|Study nurse to call patient 24 hours after participation to ask about side effects since taking part in the study. The phone call should last about 5 minutes.
16059252|NCT02459951|Other|clenched fist|Observation of performance on a standardized behavioral task pre- and post- administration of Botox A in the context of routine care. Clinical assessment and judgment will be used to determine dosing and which muscles contribute to the hand deformities of a given participant.
16059253|NCT02459938|Drug|Glucagon (ZP-Glucagon)|chemically synthesized glucagon as delivered via transdermal microneedle patch system for 30 minutes
16059254|NCT02459938|Drug|Glucagon (GlucaGen)|recombinant glucagon administered via subcutaneous injection
16059255|NCT02459925|Behavioral|CBT- Mental Health Program|Manualized Stress Management class; brief individual behavioral counseling.
16059256|NCT02459925|Behavioral|MOMS GROW|MOMS GROW (Generating Real Opportunities for Work) Teaching, coaching, and supportive services for participants as they navigate their journeys to sustainable employment that pays a family-supporting wage.
16059257|NCT02459912|Procedure|Unilateral Nerve-Sparing Cryoablation of the Prostate|The side of the prostate affected by cancer will be treated with nerve-sparing cryoablation in two freeze-thaw cycles under transrectal ultrasound guidance. The unaffected side of the prostate will not be treated.
16059258|NCT02459912|Device|Precise Cryoablation System with IceRod Needles|Galil Medical Precise Cryoablation System with IceRod Needles will be used for performing Unilateral Nerve-Sparing Cryoablation
16059259|NCT02459899|Drug|Placebo|Placebo, once daily, before the first meal of the day
16059260|NCT02459899|Drug|Sotagliflozin|Sotagliflozin,once daily, before the first meal of the day
16059261|NCT02459886|Drug|BIIB054|IV infusion
16059262|NCT02459886|Drug|Placebo|IV infusion
16059263|NCT02459873|Behavioral|Computer games to assess change in executive function skills|Children get access to computer games for 10 weeks for an hour each week.
16059264|NCT02459860|Behavioral|Problem Solving Treatment|Individual, face-to-face PST sessions over a span of 8 weeks will be held at PACE sites. The first session will last one hour while subsequent sessions will last 45 minutes. After the last PST session, each subject will have 3 monthly booster sessions (about 15 minutes). The PST protocol is intended to be highly structured, time-limited, and manual-driven; sessions include PST hand outs and homework as well as social and behavioral activation strategies, i.e., pleasant activities scheduling. All interventionists will document attendance and provide a post-session fidelity summary. 10% of the individual sessions will be videotaped with patient consent to assess fidelity and training needs.
16059265|NCT02459860|Behavioral|Enhanced Usual Care|EUC patients will receive psychoeducational materials on depression and depression treatment of older persons. EUC patients will continue to receive the full complement of PACE services (medical, rehabilitation, social) including referrals to specialty mental health services, if indicated.
16059266|NCT02459847|Behavioral|Mindfulness Training|
16059267|NCT02459847|Behavioral|Sonographic Biofeedback|
16059268|NCT02459847|Other|Standard Care|
16059269|NCT02459834|Other|Allulose|"A double-blind, randomized, multiple-crossover equivalence design. Each participant will act as their own control receiving the treatments in random order, each separated by a 1 week washout period. The treatment will be developed by Tate & Lyle."
16059270|NCT02459834|Other|Fructose|"A double-blind, randomized, multiple-crossover equivalence design. Each participant will act as their own control receiving the treatments in random order, each separated by a 1 week washout period. The treatment will be developed by Tate & Lyle."
16059271|NCT02459834|Other|Control|"A double-blind, randomized, multiple-crossover equivalence design. Each participant will act as their own control receiving the treatments in random order, each separated by a 1 week washout period. The treatment will be developed by Tate & Lyle."
16059272|NCT02459821|Other|GE-O SYSTEM|The first group will be subjected to RAGT for 9 weeks (2 sessions/ week) with a total of 18 sessions by mean of GE-O System (9). During each session, the patients will practice 15 to 20 min of simulated floor walking followed by 5 to 10 min of repetitive simulated stair climbing up and down. Breaks will be optional, but uninterrupted training intervals of at least 5 min for simulated floor walking and 3 min of simulated stair climbing will be required. When the patient reaches the maximum amount of time, speed of gait will then be progressively increased. Each session will last up to 50 minutes, the first 30 minutes will be dedicated to gait training and the last 20 minutes to stretch the lower limb's muscles.
16059273|NCT02459821|Other|Conventional training|The conventional walking group will be subjected to a conventional gait training for 9 weeks (2 sessions/week) with a total of 18 sessions. Each session will last altogether 50 minutes, the first 30 minutes will be dedicated to gait and stair climbing up and down training while the last 20 minutes to stretch the lower limb's muscles.
16059274|NCT02459795|Drug|Ingenol Mebutate (Perrigo)|
16059275|NCT02459795|Drug|Ingenol Mebutate (Reference)|
16059276|NCT02459795|Drug|Placebo gel|
16059277|NCT02459782|Procedure|Ultrasound guided Dual Quadrant Peribulbar Anaesthesia|Landmark Guided single injection vs Ultrasound guided dual quadrant injection
16059278|NCT02459769|Behavioral|Exercise for Cancer Patients|a standardized, daily, 6 week, home-based, progressive exercise program
16059279|NCT02459756|Other|Beverage: Spray dried blackcurrant powder dissolved in water|
16059280|NCT02459756|Other|Beverage: Placebo (sucrose, glucose, fructose, maltodextrin, malic acid, citric acid, vitamin C, artificial blackcurrant flavouring and low-nitrate water)|
16059281|NCT02459730|Procedure|ART with GIC containing 1.25% CHX.|Carious lesions were prepared by removing infected dentin with hand instruments. No local anesthesia was administered. Then, the cavities were filled with the press finger technique using GIC KetacMolar Easymix® containing 1.25% chlorhexidine digluconate (n= 41 tooth surfaces).
16059282|NCT02459730|Procedure|ART with GIC.|Carious lesions were prepared by removing infected dentin with hand instruments. No local anesthesia was administered. Then, the cavities were filled with the press finger technique using KetacMolar Easymix® (n = 66 tooth surfaces).
16059283|NCT02459717|Other|Probiotics and prebiotic|Patients will receive daily (at breakfast) a fermented milk (125 grams), containing multiple probiotics strains and prebiotic fiber
16059284|NCT02459717|Other|Placebo|Patients will receive daily (at breakfast) a placebo (pasteurized fermented milk without prebiotics)
16059285|NCT02459704|Procedure|Semilunar coronally positioned flap|Semilunar coronally positioned flap with enamel matrix derivative (Emdogain) or alone.
16059286|NCT02459704|Device|Enamel matrix derivative (Emdogain)|Enamel matrix derivative associated to semilunar coronally positioned flap (SCPF + EMD - test group)
16059287|NCT02459691|Behavioral|Vida Sana|Vida Sana is a Diabetes Prevention Program-based, culturally-adapted intervention that will have 2 distinct stages: The intensive treatment stage will implement a culturally adapted year-long Group Lifestyle Balance curriculum. The curriculum uses a goal-based approach to promote positive outcome expectancies and foster self-efficacy. The maintenance stage will be focused on (1) facilitating continued behavior change; (2) fostering participants' self-efficacy and independence; and (3) reinforcing problem-solving and behavior maintenance skills. These will be done via secure e-messaging.
16059288|NCT02459691|Other|Usual Care Only|Patients assigned to this group will continue medical care as usual. That is, they will continue to see their primary care provider and any specialist he/she may recommend. They may also access additional health education resources available at the Palo Alto Medical Foundation. They will continue to receive general age and gender-appropriate reminders of health maintenance tests/exams and immunizations, per Palo Alto Medical Foundation standard practice.
16059289|NCT02459678|Behavioral|Enhanced Adherence Package|The enhanced adherence package is yet to be designed, but may target all HIV-infected women with methods that are currently reserved only for late clients or clients of unknown status.
16059290|NCT02459678|Other|Standard of Care|Currently, the standard of care is based on the 2010 national HIV care and treatment guidelines, health care providers are encouraged to use a number of different means to improve ART adherence.
16059291|NCT02459665|Biological|Vaginal multiple lactobacilli-containing probiotic for prevention of BV recurrence|Vaginal probiotic to restore the vaginal microbiome and prevent BV recurrence after metronidazole treatment for BV or TV
16059292|NCT02459665|Drug|Prophylactic use of metronidazole pills (500 mg)|Prophylactic use of metronidazole pills to prevent BV recurrence after metronidazole treatment for BV or TV
16059293|NCT02459665|Biological|Vaginal Lcr35-containing probiotic for prevention of BV recurrence|Vaginal probiotic to restore the vaginal microbiome and prevent BV recurrence after metronidazole treatment for BV or TV
16059294|NCT02459652|Drug|S-1|S-1 is administered orally at a dose of 40 mg/m2 twice daily on the day of irradiation (Monday through Friday) during radiation therapy.
16059295|NCT02459652|Radiation|Radiation Therapy|Radiation therapy is delivered with >6-megavolts (MV) photons, using a multiple field technique. A total dose of 50.4 Gy is delivered in 28 fractions over 5.5 weeks.
16059296|NCT02459639|Other|Anthroposophic integrative care rehabilitation program|"The programme for chronic pain at AIC consists of two phases:
~A three-week in-patient period. During the first three-week in-patient stay, patients meet regularly with a multi-professional team. Usually, each patient receives two of the following therapies 2-4 times per week: art therapy, massage, physiotherapy, eurhythmy and baths. Nursing care is provided twice daily. Moreover, patients are offered to participate in group activities.
~Two-three day inpatient follow-up and treatment period closure. The second phase of the treatment programme consists of a 2-3 day inpatient stay, 6 months after closure. During this time, physician, nurse and therapist appointments are made according to individual needs. The patients who have been engaged in group activities are gathered in groups."
16059330|NCT02459405|Device|Near infrared camera|Use of the Pinpoint laparoscopic scope (Novadaq, Vancouver, Canada) after injection of indocyanine green
16059363|NCT02459171|Other|Questionnaire|Once at enrollment, subjects will complete an enrollment question to capture poultry exposure and other demographic information. Information will be updated if needed at annual follow-up and at final visits.
16059395|NCT02458872|Behavioral|safety huddle alarm intervention|The intervention consists of a monitor alarm dashboard that displays the numbers and types of alarms for each patient, and an accompanying checklist to guide data-driven discussion of 2-4 patients with high alarm rates.
16059297|NCT02459639|Other|Conventional multi-modal care rehabilitation|The standard approach at Linköping University Hospital admits patients for bio-psycho-social assessment, pharmacological treatment and multimodal rehabilitation (main components: education, intense physical exercise, cognitive behavioural therapy and workplace interventions) for a 6 week intensive phase period (75%) followed by 4 weeks (25%). Here a number of professional disciplines collaborate and form a team of professionals focused on individual patient needs The multimodal rehabilitation outpatient program delivered by this team has the following aims: 1) reduce pain and psychological burden, 2) improve work capacity and decrease sick-leave and 3) increase perceived health and quality of life. These general aims are combined with the aims of the patient in a plan of rehabilitation.
16059298|NCT02459626|Other|Diagnostic P-V-loops and MRI|Invasive assessment of P-V-loops during catheterization for suspected CAD Magnetic resonance Imaging for assessment of myocardial fibrosis and biventricular function
16059299|NCT02459613|Drug|99mTc-Annexin V-128 SPECT|
16059300|NCT02459600|Other|instulling cyclopentolate drops in the eye|measuring refraction with and wirthout cyclopentolate drops under general anesthesia
16059301|NCT02459587|Behavioral|Crisis Line Facilitation (CLF)|This single session therapist-delivered intervention addresses Veterans' perceived barriers and facilitators of crisis line use during periods of suicidal crisis. The CLF session culminates with the Veteran calling the Crisis Line with the therapist in the room as a way for the Veteran to practice the logistics of making the call and to have direct experiences that may counter any negative beliefs about Crisis Line use.
16059302|NCT02459587|Behavioral|Enhanced Usual Care (EUC)|Those in the EUC condition received the same promotional items and information about the Veterans Crisis Line (VCL) as the CLF condition. Participants were encouraged to seek help via a provider or the VCL if they felt suicidal in the future. Research staff briefly explained key information about the VCL to those in the EUC condition (e.g., the links between the VCL and the VA, the 24/7/365 availability, etc.).
16059303|NCT02459574|Procedure|AVATAR-AF ablation|Experimental ablation protocol
16059304|NCT02459574|Drug|Anti-Arrhythmic therapy|"Group 2 will be prescribed medication listed below:
~Amiodarone; Dronaderone; Sotalol Beta blockers; Calcium channel blockers; Flecainide; or Propafenone.
~You will then be discharged from clinic. A research nurse will contact you by phone to make sure there are no problems and can make hospital appointments if needed."
16059305|NCT02459574|Procedure|Conventional AF ablation|Conventional ablation procedure
16059306|NCT02459561|Device|EndoBarrier TM Gastrointestinal Liner|If subjects are randomised into the EndoBarrier Group of the trial they will receive the device for 12 months followed a 12 months follow-up period.
16059307|NCT02459561|Other|Best Medical Care|If subjects are randomised into the Control Group of the trial they will receive best medical care and dietitian advice for 12 months followed a 12 months follow-up period.
16059308|NCT02459548|Other|Follow up in Sleep Unit Group|Compare the results of a program of treatment and follow-up by Primary Care in patients with obstructive sleep apnea on CPAP treatment, versus the usual practice of control by the Sleep Unit.
16059309|NCT02459548|Other|Follow up in Primary Care Group|Compare the results of a program of treatment and follow-up by Primary Care in patients with obstructive sleep apnea on CPAP treatment, versus the usual practice of control by the Sleep Unit.
16059310|NCT02459535|Other|oral stimulation glucose|oral stimulation with glucose, AS or glucose+AS in fasted state, blood samples from fasted state up to 120 min post-ingestion
16059311|NCT02459535|Other|oral stimulation saccharin|
16059312|NCT02459535|Other|oral stimulation aspartame|
16059313|NCT02459535|Other|oral stimulation sucralose|
16059314|NCT02459522|Other|not intervention|This is a cross-sectional study for estimation of diagnostic performance.
16059315|NCT02459509|Drug|Dexmedetomidine|Either 2mcg/kg or 4mcg/kg of intranasal dexmedetomidine will be given to assess efficacy of preoperative sedation
16059316|NCT02459496|Behavioral|dietary consulting and advise|first phase: 3 weeks of very-low calory diet (low-carb or normo-carb) second phase: 49 weeks of eucaloric diet under DGE guidelines
16059317|NCT02459483|Behavioral|Nurse phone call|
16059318|NCT02459470|Procedure|Fluid loading|fluid loading was performed by using 7ml/kg of 6% hydroxyethyl starch within 10 min to all patients
16059319|NCT02459457|Drug|Paclitaxel and Cisplatin|patients get Paclitaxel and Cisplatin according to protocol
16059320|NCT02459457|Drug|Paclitaxel and Fluorouracil|patients get Paclitaxel and Fluorouracil according to protocol
16059321|NCT02459457|Drug|Paclitaxel and Carboplatin|patients get Paclitaxel and Carboplatin according to protocol
16059322|NCT02459457|Radiation|Radiotherapy|1.8Gy/d, d1-5/week, 34Fx
16059323|NCT02459444|Device|Powerbreathe|Respiratory equipment for physiotherapy, offering to load muscles inspiratory
16059324|NCT02459444|Other|Physiotherapy|This was contemplated cinesioterapia unloaded, muscle stretching, coughing technique, sedestração and ambulation if the participant was fit.
16059325|NCT02459431|Other|21 G needle group|Patients with a clinico radiologic suspicion of sarcoidosis will undergo endobronchial ultrasound guided transbronchial needle aspiration with 21 G needle, by random assignment
16059326|NCT02459431|Other|22 G needle group|Patients with a clinico radiologic suspicion of sarcoidosis will undergo endobronchial ultrasound guided transbronchial needle aspiration with 22 G needle, by random assignment
16059327|NCT02459418|Drug|Afolia|"During the Cross-Over Pharmacokinetic Phase, subjects will be randomly assigned to receive one of the following treatment sequences:
~Sequence A: Single subcutaneous injection of 225IU Afolia on study day 1, followed by a single subcutaneous injection of 225IU US Gonal-f® on study day 27.
~Sequence B: Single subcutaneous injection of 225IU US Gonal-f® on study day 1, followed by a single subcutaneous injection of 225IU Afolia on study day 27"
16059328|NCT02459418|Drug|US Gonal-f®|"During the Cross-Over Pharmacokinetic Phase, subjects will be randomly assigned to receive one of the following treatment sequences:
~Sequence A: Single subcutaneous injection of 225IU Afolia on study day 1, followed by a single subcutaneous injection of 225IU US Gonal-f® on study day 27.
~Sequence B: Single subcutaneous injection of 225IU US Gonal-f® on study day 1, followed by a single subcutaneous injection of 225IU Afolia on study day 27"
16059329|NCT02459405|Procedure|NIR anastomotic perfusion assessment|Patient will have their anastomosis assessed by near infrared technology after indocyanine green has been injected i.v. The procedure will be repeated twice, once before the anastomosis and the second time after the anastomosis has been performed.
16059331|NCT02459392|Other|Epiduroscopy|"Epiduroscopy has two main uses in the pain clinic:
~Releasing epidural adhesions for the relief of chronic sciatica. Adhesions can form around the lower lumbar nerve roots after decompressive surgery for disc disease or after a bad bout of inflammatory sciatica in the absence of surgery. Epidural adhesions can usually be identified on an enhanced magnetic resonance scan using intravenous gadolinium. They also cause uneven spread of X-ray contrast when performing an epidurogram.
~Injecting mixtures of local anesthetic and depot steroid around inflamed nerve roots when epidural injections / nerve root blocks have been unsuccessful. The presence of adhesions can prevent epidurally injected drugs from reaching the inflamed nerve roots."
16059332|NCT02459392|Drug|Hyaluronic Acid|Drug administration
16059333|NCT02459392|Drug|DepoMedrol|Drug administration
16059334|NCT02459379|Radiation|MRI Scan|MRI will be performed for clinical reason for which no other imaging study will provide the data required on patients with pacemaker or implantable defibrillator
16059335|NCT02459353|Drug|Dapagliflozin|
16059336|NCT02459353|Drug|Placebo|
16059337|NCT02459340|Other|therapeutic treatment (inpatient and outpatient setting)|
16059338|NCT02459327|Behavioral|Video Interaction Project|VIP utilizes pediatric well-child visits to build a relationship with an interventionist who facilitates self-reflection regarding interactions with the child through review of videotapes of the parent and child made that day and further facilitates interactions through provision of learning materials (toys and books).
16059339|NCT02459327|Behavioral|Family Check Up|FCU utilizes home visitation to build a relationship with an interventionist who assesses family strengths and challenges and uses motivational interviewing and evidence-based family management strategies to support parent and child behavioral change.
16059340|NCT02459314|Dietary Supplement|plant sterol and soluble fiber-enriched soymilk|Sterols compete with LDL-C for absorption in GI tract. A meta-analysis of 41 trials indicated that an intake of 2 g sterols/stanols reduces the LDL-C level by 10%. Additive effects occur when sterols are combined with statins; the combination being more efficacious than a 2 times up-dosing of statins alone. Soluble dietary fibers also have significant cholesterol lowering effects. In a meta-analysis, Brown et al estimate that a daily soluble fiber intake ranging from 9-30 g/d, were associated with 10.6% reduction in LDL-C levels.
16059341|NCT02459314|Dietary Supplement|soymilk|Soy protein is another LDL-C and total cholesterol lowering food. A meta-analysis by Reynolds K et al. discovered that volunteers receiving 20 to more than 61 g of soy protein had reductions in total cholesterol by 5.26 mg/dL (95% CI -7.14 to -3.38), and LDL-C by 4.25 mg/dL (95% CI -6.00 to -2.50), with an increase of HDL-C by 0.77 mg/dL (95% CI 0.20 to 1.34). Reductions in LDL cholesterol were larger in hypercholesterolemic than in normocholesterolemic subjects.
16059342|NCT02459301|Drug|IPH2201|
16059343|NCT02459288|Drug|Clopidogrel first|After randomization, 2 weeks Clopidogrel (Plavix) 75 mg QD will be given and then crossover with following 2 weeks Ticagrelor (Brilinta) 90 mg bd
16059344|NCT02459288|Drug|Ticagrelor first|After randomization, 2 weeks Ticagrelor (Brilinta) 90 mg bd will be given then crossover with following 2 weeks Clopidogrel (Plavix) 75 mg QD
16059345|NCT02459275|Other|PEP uP Protocol|Semi-elemental tube feeds are started at the hourly goal rate as determined by the 24 hour volume goal. Protein supplements will be started at the initiation of tube feeds to target a daily delivery of 2 g/kg/day.
16059346|NCT02459275|Drug|Metoclopramide|Metoclopramide 10mg Intravenous (IV) every 6 hours (q6h) or 5mg IV q6h for renal failure will be started empirically concomitant with EN initiation. Gastric Residual Volume (GRV) will be checked every 4 hours and will be reinfused to the patient each time it is checked.
16059347|NCT02459262|Biological|GBS-NN vaccine|Three dose levels will be administered, with and without Alhydrogel®
16059348|NCT02459249|Other|Healthy Lifestyle|A physician and a nutritionist will be give recommendations for diet and exercise emphasizing the importance of a healthy lifestyle (suggesting moderate-intensity activity at least 150 minutes/week and to eat less sodium, fat, sugar, portions and calories). Verbal and written individualized recommendations from trained professionals (nutritionists, and physician) will be provided. Monthly sessions of at least 30 minutes covering diet, exercise, and behavior modifications were held. The first was a one-to-one meeting and was followed by group sessions based on behavioral counseling
16059349|NCT02459249|Other|Placebo Comparator (Treatment of Mexican Health Minister)|General and unspecific recommendations of diet and physical activity for the metabolic syndrome treatment, given for a physician
16059350|NCT02459236|Drug|CERC-301|CERC-301, a highly selective, orally bioavailable, NMDA receptor subunit 2B (NR2B), also referred to as Glutamate NMDA receptor subunit epsilon-2 (GluN2B) antagonist
16059351|NCT02459236|Drug|Placebo|
16059352|NCT02459223|Dietary Supplement|Nutritional biscuits and khichadi|Nutritional biscuits and Khichadi.
16059353|NCT02459223|Dietary Supplement|Khichadi|Khichadi.
16059354|NCT02459210|Behavioral|CLUES|Cognition for learning and for understanding everyday social situations intervention described above
16059355|NCT02459210|Behavioral|therapy and computer games|Weekly psychotherapy+ computer games such as sporcle
16059356|NCT02459197|Behavioral|Heat Pain Stimuli A|
16059357|NCT02459197|Behavioral|Heat Pain Stimuli B|
16059358|NCT02459197|Behavioral|Positive Video|
16059359|NCT02459197|Behavioral|Neutral Video|
16059360|NCT02459197|Drug|Administration of T4P1001 capsules|This treatment is given as add-on therapy to patient's regular analgesic treatment
16059361|NCT02459197|Drug|Administration of Placebo capsules|This treatment is given as add-on therapy to patient's regular analgesic treatment
16059362|NCT02459184|Other|Income Security Health Promotion|"The ISHP will work to improve the income security of participants within this study. To that end, her activities include:
~Providing one-to-one case management support and ongoing follow-up to diverse low-income patients and families regarding their income security.
~Developing and implementing targeted information self-help sessions, such as; banking basics, income tax submissions, and social service forms, for the target population
~Developing and maintaining up-to-date detailed knowledge of financial issues and financial services affecting low-income people, and applying this knowledge in his/her work.
~Assisting individual low-income patients with income security-focused interventions, including access to tax benefits, applications for income security programs such as social assistance and seniors and child benefits, and navigation of disability support programs."
16059935|NCT02455011|Biological|REMD-477|
16059364|NCT02459171|Other|Blood sample|"Participants will have a 3-mo blood sample drawn for serological testing at enrollment, and at annual follow-up and final visits.
~For subjects who test positive for influenza A by rapid test or PCR (index case) on nasal swab at the biweekly or weekly visits, two 3-ml blood samples will be obtained from the index case on day 1 for serological testing for antibodies against avian influenza viruses and for isolating and studying PBMCs. Blood samples will also be obtained on day 1 from all household contacts of the index case. Additional 3-ml blood samples will be obtained on day 14 for serology and PBMCs."
16059365|NCT02459171|Other|Nasal wash|Nasal washes will be obtained from subjects who test positive for influenza A by rapid test or PCR on nasal swab (index case). Nasal washes will also be obtained from all household contacts of the index case. The index case and household contacts will be re-sampled on days 3, 6, 9 and 14 post initial diagnosis date.
16059366|NCT02459171|Other|Throat swab|Throat swabs will be obtained from subjects who test positive for influenza A by rapid test or PCR on nasal swab (index case). Throat swabs will also be obtained from all household contacts of the index case. The index case and household contacts will be re-sampled on days 3, 6, 9 and 14 post initial diagnosis date.
16059367|NCT02459158|Drug|ME1100 inhalation solution|Low dose of ME1100 inhalation solution twice daily for up to 14 days to be administered via eFlow nebulizer system
16059368|NCT02459158|Drug|ME1100 inhalation solution|High dose of ME1100 inhalation solution twice daily for up to 14 days to be administered via eFlow nebulizer system
16059369|NCT02459145|Behavioral|Graduated exercise protocol|Intervention involves exercise protocols starting at 50% of maximum age-adjusted heart rate (MHR) for 10 minutes (warm-up and Recovery)_ plus 5 minutes of target heart rate per day 5 days a week for 2 weeks, supervised by the athletic trainer or parent. The protocol increases the intensity of target heart rate by 10% MHR and duration of 50% MHR by 2 minutes every 2 weeks if there is no symptom exacerbation.
16059370|NCT02459132|Behavioral|High-intensity aerobic interval exercise|See arm/group description
16059371|NCT02459119|Drug|Regorafenib|Regorafenib will be packaged as 40 mg tablets in a bottle. Patients will be instructed to maintain a daily medication calendar.
16059372|NCT02459093|Device|poliglecaprone 25 suture|cesarean delivery incision closure with poliglecaprone 25 suture
16059373|NCT02459093|Device|polyglactin 910 suture|cesarean delivery incision closure with polyglactin 910 suture
16059374|NCT02459080|Drug|TD-4208|
16059375|NCT02459080|Drug|Placebo|
16059376|NCT02459067|Biological|ImmuniCell®|Autologous γδ T Lymphocytes
16059377|NCT02459054|Device|SynCardia 50cc temporary Total Artificial Heart (TAH-t)|Replacement of both ventricles and all four valves with the investigational device as a bridge to transplantation.
16059378|NCT02459041|Other|Elastography, contrast enhancement|"Elastography is an ultrasound method used for the reconstruction of tissue elasticity distribution in real-time. The main intended use is to differentiate between benign and malignant focal lesions based on the significantly smaller strain of the latter real time. Tissue elastography can be easily performed with conventional probes, including the linear EUS probes used for the examination of the pancreas and/or lymph nodes.
~Contrast-enhancement Ultrasound contrast agents in conjunction with contrast specific imaging techniques are increasingly accepted in clinical use for diagnostic imaging. Pancreatic adenocarcinomas are usually hypovascular tumors."
16059379|NCT02459028|Behavioral|Positive Psychology intervention|"Intervention group: Participants are instructed to practice 4 out of 10 differentPositive Psychology Exercises (Gratitude, Optimism, Act of Kindness, Social Relations, Forgiveness, Flow, Savoring, Goals, Spirituality, Taking Care of the Body) for at least 15 minutes, at least one day every week including on bad days (defined as days with higher than average levels of pain intensity or feeling down in the dumps) for 8 weeks."
16059380|NCT02459028|Behavioral|Positive Psychology intervention (Control exercise)|Control group: Control Exercise (Attention Training): Participants assigned to the control group are instructed to be more attentive to their surroundings and write about three specific events or activities from the past 7 days for at least 15 minutes once a week for 8 weeks. This condition is designed to control for the effects of time and participation in an intervention activity.
16059381|NCT02459015|Device|Implantation|A peripheral nerve defect up to 26 mm in the finger will be repaired by implantation of either a Reaxon® Nerve Guide or an autologous nerve graft (depending on the randomization group) on day 0.
16059382|NCT02459002|Behavioral|QOL Questionnaire|Participant outcomes assessed with survey
16059383|NCT02459002|Behavioral|Caregiver Satisfaction Questionnaire|Caregiver satisfaction with quality of care assessed with surveys
16059384|NCT02458989|Procedure|Scalpel|Use of a scalpel as a first incision during thyroid operation
16059385|NCT02458989|Procedure|Electrocautery|Use of an electrocautery as a first incision during thyroid operation
16059386|NCT02458976|Device|PDL|
16059387|NCT02458963|Procedure|IVF|Women will undergo one IVF cycle
16059388|NCT02458963|Drug|Gonadotropin|Women will be subjected to ovarian stimulation for 6 months with the gonadotropin low-dose step-down protocol
16059389|NCT02458937|Other|Functional Mobility Assessment|Functional Mobility Assessment (FMA) is a tool that was developed to measure functional mobility in children and adolescents with lower-extremity sarcoma. It is comprised of well-established outcome measures that examine various domains of function. The six categories tested by the FMA include pain, functional mobility, use of assistive devices, satisfaction with quality of gait, participation in the community, and endurance.
16059390|NCT02458937|Other|GAITRite® System|Subjects will be required to walk at a self-selected comfortable pace and again at fast speed. Software will then calculate and report the temporo-spatial gait parameters for collection and evaluation by the primary investigator.
16059391|NCT02458937|Other|Range of Motion|Measurements will include hip flexion, hip abduction and adduction, and hip internal and external rotation. Range of motion (ROM) will be attempted on bilateral lower extremities, however if post-operative ROM precautions are implemented, the involved extremity will not be measured. Goniometry is a reliable and valid measure for active and passive ROM when following standardized procedures.
16059392|NCT02458924|Biological|Niacin skin test|Two concentrations including 0.5 ml solutions of 0.01 M and 0.1 M diluted methyl nicotinate were applied for one minute to the inside of the different forearms of each individual.
16059393|NCT02458911|Device|Paclitaxel-eluting balloon|
16059394|NCT02458898|Behavioral|Educational Text Message Reminders|45 unique text messages designed by the Stanford Pediatric Gastroenterology physicians and nutritionists
16059396|NCT02458859|Device|PICO (single use portable negative pressure wound therapy)|Single use portable negative pressure wound therapy
16059397|NCT02458846|Other|Crowded HOTV Acuity Test|This is one of the most sensitive tests of acuity for vision screening of young children. The child is asked to recognize a letter (H,O,T,V) that is surrounded by bars to induce the crowding effects typical of amblyopia. Children were tested monocularly and was required to achieve at least 20/32 in each eye to pass. Children already wearing glasses were tested with their glasses on.
16059398|NCT02458846|Other|Preschool Randot Stereoacuity Test|"This is a reliable screening test for stereo depth perception for young children. Children wear polarized stereoglasses and are asked to identify or match shapes that are hiding in the snow, which cannot be perceived if the child has abnormal binocular vision. Children were required to achieve at least 60 arcseconds of disparity to pass. Children already wearing glasses were tested with their glasses worn under the stereo glasses."
16059399|NCT02458846|Device|Plusoptix Autorefractor|Autorefractors are electronic devices that measure refractive errors by focusing a light onto the child's eyes and recording how their reflections from the retina return to the camera. The Plusoptix has been shown to have high sensitivity and specificity in previous research. AAPOS (2013) guidelines were used to determine the referral criteria.
16059400|NCT02458846|Other|Comprehensive Eye Exam|Children who did not pass all three screening tests were referred for full cycloplegic optometry exams, with a parent/guardian present. Optometrists assessed visual history, monocular visual acuity (near & far), strabismus, binocular function, abnormalities of the anterior segment, and cycloplegic refraction. If the optometrist prescribed glasses, frames were chosen at the time of the exam and the glasses were dispensed either at school (with an optician) or at the optometrist's office.
16059401|NCT02458833|Behavioral|Home Plate|Home Plate is a community-based, peer mentored intervention aimed at improving home food preparation practices in families with young children. Through 6 classes, this intervention explores topics related to regularly preparing healthy foods at home.
16059402|NCT02458820|Procedure|DSA EEG|Color density spectral array (DSA) is a quantitative electroencephalogram (EEG) technique that uses Fourier transformation to present EEG power (amplitude2/Hz, by color) and frequency (y-axis) over time (x-axis). It is commercially available and used routinely by neurophysiologists for EEG interpretation. Up to several hours of EEG can be displayed as a single image.
16059403|NCT02458794|Procedure|function tests|ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric tube insertion
16059404|NCT02458794|Device|LMA SupremeTM|
16059405|NCT02458794|Device|Ambu-Aura GainTM|
16059406|NCT02458781|Drug|Metronidazole|Metronidazole 500mg given twice daily for 14 days
16059407|NCT02458781|Drug|Ciprofloxacin|Ciprofloxacin 500mg given twice daily for 14 days
16059408|NCT02458781|Drug|Placebo|Placebo given twice daily for 14 days
16059409|NCT02458768|Drug|IVF-M HP Inj.|
16059410|NCT02458768|Drug|Menopur® Inj.|
16059411|NCT02458755|Drug|High-dose statin: Atorvastatin 40mg or Rosuvastatin 20mg|Atorvastatin 40mg or Rosuvastatin 20mg
16059412|NCT02458742|Drug|Morphine|0.5%Hyperbaric bupivacaine 2 ml add morphine 50 mcg for spinal anesthesia
16059413|NCT02458742|Drug|Placebo|0.5%Hyperbaric bupivacaine 2 ml for spinal anesthesia
16059414|NCT02458729|Drug|Tranexamic Acid 5%,5ml/amp (intraoperative)|tranexamic acid 1g administered intravenously five minutes before deflation of the tourniquet
16059415|NCT02458729|Drug|Tranexamic Acid 5%,5ml/amp (3 hours after operation)|tranexamic acid 1g administered intravenously 3 hours after operation
16059416|NCT02458729|Drug|0.9% Normal Saline (intraoperative)|0.9% Normal Saline 20ml administered intravenously five minutes before deflation of the tourniquet
16059417|NCT02458729|Drug|0.9% Normal Saline (3 hours after operation)|0.9% Normal Saline 20ml administered intravenously 3 hours after operation
16059418|NCT02458729|Drug|rivaroxaban (10mg)|Oral rivaroxabam (10mg) QD on PostOp Day 1 to 14
16059419|NCT02458716|Procedure|Robotic Assisted Radical Prostatectomy|Undergo RARP
16059420|NCT02458716|Procedure|Conventional open retropubic radical prostectomy|Undergo conventional open RRP
16059421|NCT02458716|Other|Laboratory Biomarker Analysis|Correlative studies
16059422|NCT02458716|Other|Quality-of-Life Assessment|Ancillary studies
16059423|NCT02458716|Drug|ADT (androgen deprivation therapy) (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide)|LHRH agonist or antagonist (i.e. leuprolide) plus an androgen receptor inhibitor (i.e. bicalutamide)
16059424|NCT02458703|Other|Cardiopulmonary exercise test|"Subjects will have the test in the Exercise Suite of Hammersmith Hospital, London, UK. They will have painless skin probes placed on their fingers, chest, and legs to monitor heart rate, ECG, blood oxygen levels, and oxygen delivery during the test. Subjects will also be shown how to breathe through a mouthpiece with a nose clip on, and how to indicate on a sliding device whether they feel breathless. They will then start cycling against a very low resistance at a steady speed. As long as they feel comfortable, there will be a gradual increase in work load until they feel they cannot keep going at the same speed. They can also stop sooner for any reason. Afterwards, while they are cooling down, they will fill in a short questionnaire describing how they feel. 20-30mls of blood will be taken for analysis."
16059425|NCT02458690|Behavioral|Beating the Blues (BtB)|BTB is a widely used, empirically supported, stand-alone CBT program for depression designed for primary care patients and appropriate for adults with little computer experience and a 5th-6th grade reading level. BtB utilizes an interactive, multimedia format to deliver eight 50-minute, weekly therapy sessions. Although sessions are tailored to each patient's problems, general topics include challenging dysfunctional thoughts, activity scheduling, problem solving, graded exposure, task breakdown, sleep management, and relapse prevention. Patients are also assigned tailored homeworks that are customized to their needs and reviewed at the start of each session.
16059426|NCT02458690|Behavioral|Problem Solving Treatment in Primary Care (PST-PC)|PST-PC is a manualized, empirically supported CBT developed for use by healthcare professionals in primary care. The focus of the 6-10 30-minute sessions is teaching patients approaches for solving current problems contributing to depression. We are delivering PST-PC via telephone.
16059491|NCT02458209|Biological|bococizumab PFS:Pfizer|150 mg bococizumab administered SC in a prefilled syringe using drug substance manufactured at Pfizer Andover
16059492|NCT02458209|Biological|bococizumab PFS: BIP|150 mg bococizumab administered SC in a prefilled syringe using drug substance manufactured at Boehringer Ingelheim Pharma.
16059427|NCT02458690|Drug|Antidepressant Medications|The IMPACT treatment manual provides guidelines for using antidepressants, such as selecting a medication, titrating, switching to another medication, managing side effects, and avoiding drug interactions. To optimize eIMPACT for CVD risk reduction, we have restricted the IMPACT list of antidepressants to SSRIs (sertraline, escitalopram, paroxetine, fluoxetine, citalopram), duloxetine, bupropion, and mirtazapine. These medications are FDA approved for the treatment of depression and are the safest from a cardiovascular perspective.
16059428|NCT02458690|Other|Usual Care|Patients randomized to usual primary care for depression are informed of their depression diagnosis, encouraged to follow-up with their Eskenazi Health primary care provider, and provided a list of local mental health services. The patient's primary care provider will receive a letter indicating that their patient has a depressive disorder and was randomized to usual care. This letter also provides a list of local mental health services. Like those in the intervention group, usual care patients continue to have access to services that are part of usual care in the targeted systems. There are no restrictions on the care received. The Eskenazi Health primary care clinics utilize a team care approach, with PCPs supported by embedded behavioral health clinicians and affiliated psychiatrists.
16059429|NCT02458677|Drug|PRX003|
16059430|NCT02458677|Other|Placebo|
16059431|NCT02458664|Genetic|Genetic analysis on tumor kept in tumor bank|
16059432|NCT02458651|Other|No intervention|No intervention administered in this study
16059433|NCT02458638|Drug|Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (PD-L1) antibody|Atezolizumab will be given as IV infusion over 60 minutes on Day 1 of Cycle 1, then over 30 minutes (as tolerated) on Day 1 of each subsequent 3-week cycle.
16059434|NCT02458625|Dietary Supplement|Iron sucrose 500 mg|
16059435|NCT02458625|Dietary Supplement|Iron bisglycinate 60 mg|
16059436|NCT02458612|Other|control group|We will apply traditional physiotherapy including upper limb exercises in three times a week for 12 week.
16059437|NCT02458612|Other|intervention group|"Participants allocated to the experimental group completed three times a week, 12-week mirror therapy combined with progressive strength training. This protocol consisted of mirror therapy with a mirror box, strength training with Thera-band and exercises for scapular dyskinesis. This intensity of training is approximately equal to training at an intensity of 60% to 80% of one-repetition maximum according to National Strength and Conditioning Association (NSCA) protocols. Intensity of exercise is gradually increased 10% bi-weekly."
16059438|NCT02458599|Dietary Supplement|Test product|Whey protein hydrolysate (20 g)
16059439|NCT02458599|Dietary Supplement|Reference product 1|Iso-energetic carbohydrate (20 g)
16059440|NCT02458599|Dietary Supplement|Reference product 2|Negligible energy placebo (20 g)
16059441|NCT02458586|Dietary Supplement|Dietary intervention / counseling|dietary counseling and daily intake of 50 g of dietary oil over a period of 8 weeks
16059442|NCT02458573|Other|continuous epidural analgesia|the continuous epidural analgesia group: epidural analgesia started from induction of anesthesia and continued for 48 h.
16059443|NCT02458573|Other|continuous intravenous analgesia|the continuous intravenous analgesia group: intravenous analgesia started from induction of anesthesia and continued for 48 h.
16059445|NCT02458547|Drug|Desflurane|Inhalation anesthesia with desflurane at age-adjusted MAC of 0.8~1.0
16059446|NCT02458547|Drug|Propofol|Total intravenous anesthesia with propofol target controlled infusion
16059447|NCT02458547|Drug|Bupivacaine|Spinal anesthesia with 0.5% bupivacaine
16059448|NCT02458534|Other|Mcgrath Mac videolaryngoscope|Participants perform three intubation attempts using Mcgrath Mac videolaryngoscope in the manikin with the normal airway and difficult airway settings.
16059449|NCT02458534|Other|C-MAC videolaryngoscope|Participants perform three intubation attempts using C-MAC videolaryngoscope in the manikin with the normal airway and difficult airway settings.
16059450|NCT02458534|Other|macintosh laryngoscope|Participants perform three intubation attempts using macintosh laryngoscope in the manikin with the normal airway and difficult airway settings.
16059451|NCT02458521|Device|Transcranial Magnetic Stimulation|Treatment will consist of 30 sessions of TMS over approximately 7 weeks. More specifically, the active or sham TMS treatments will be conducted five times a week for 5 consecutive weeks, followed by a tapering of three sessions during week 6 and two sessions during week 7. TMS sessions will consist of both 10 Hz left pre-frontal stimulation for 3,500 pulses followed by 1 Hz right pre-frontal stimulation for 1,500 pulses per session, for a total stimulation time of approximately one hour per session. These pulse sequences have theoretical targets that may be implicated in conditions of poor resiliency, apathy, depression and anxiety.
16059452|NCT02458521|Device|Sham Transcranial Magnetic Stimulation|Treatment will consist of 30 sessions of TMS over approximately 7 weeks. More specifically, the active or sham TMS treatments will be conducted five times a week for 5 consecutive weeks, followed by a tapering of three sessions during week 6 and two sessions during week 7. The TMS system will have three coils, one designated active and the other two unlabeled and identical in appearance, weight, and noises emitted, one of which will be active and one of which will be sham.
16059453|NCT02458495|Behavioral|Diabetes MAP Intervention|
16059454|NCT02458482|Device|AccuPAP|The AccuPAP device used by participants will give 2.5mg and 0.5mg nebulized Albuterol and Ipratropium over 5 minutes. Inspiratory and expiratory pressures to be set at 6 and 12 cm H20 respectively. This therapy is repeated at 20 and 40 minutes for a total of three AccuPAP treatments.
16059455|NCT02458482|Drug|Albuterol and Ipratropium Continuous Nebulizer|10mg Albuterol and 1.5mg Ipratropium continuous nebulizer treatment will be administered to a Control group over a one hour period.
16059456|NCT02458469|Drug|Buspirone|The initial dose of Buspirone is 15 mg daily (7.5 mg bid.). To achieve an optimal therapeutic response, at intervals of 2 to 3 days the dosage may be increased 5 mg per day until a maximum dose 30mg/day is reached.
16059457|NCT02458469|Drug|Trazodone|100 mg dose before bed-time
16059458|NCT02458469|Drug|Placebo|One placebo pill before bed-time
16059459|NCT02458456|Other|Isometric resistance training|Isometric exercise using a hand dynamometer.
16059460|NCT02458443|Other|Isometric resistance training|Isometric handgrip exercise using a hand dynamometer
16059461|NCT02458417|Device|ReCell|A split-thickness skin biopsy will be taken from the hip region of the patient. The skin biopsy that is obtained will be treated in the ReCell kit (Avita Medical Europe Ltd, Cambridge, UK): it will be placed in the heated enzyme solution, containing trypsin, in the device for 15-20 minutes to allow cell disaggregation. After that period, the biopsy will be taken from the enzyme solution and will be dipped in sodium lactate buffer solution. The biopsy will then be scraped to disaggregate the cells from the dermal epidermal junction. The epidermal cells are drawn up in a syringe. The prepared suspension will be dripped on both donor and acceptor site.
16059462|NCT02458417|Device|Full surface CO2 laser 200 mJ|Full surface pretreatment with the CO2 laser (Ultrapulse, ActiveFX handpiece, Lumenis Inc., Santa Clara, CA, USA) at 200 mJ (depth 144 µm) and density 3
16059463|NCT02458417|Device|Full surface CO2 laser 150 mJ|Full surface pretreatment with the CO2 laser (Ultrapulse, ActiveFX handpiece, Lumenis Inc., Santa Clara, CA, USA) at 150 mJ (depth 144 µm) and density 3
16059464|NCT02458417|Device|Fractional CO2 laser 7.5 mJ, 20%|Pretreatment with the fractional CO2 laser (Ultrapulse, DeepFX handpiece, Lumenis Inc., Santa Clara, CA, USA) at 7.5 mJ/microbeam (depth 225 µm) and 20% density.
16059465|NCT02458391|Other|Standard of care complete decongestive therapy|Participants will receive standard of care complete decongestive therapy consisting of meticulous skin and nail care, manual lymphatic drainage, compression bandaging, remedial exercises and self-care training.
16059466|NCT02458365|Behavioral|Teen Choices: A Program for Healthy Nonviolent Relationships|A 3-session online, multimedia TTM-based intervention for teen dating violence prevention. For most students, the intervention seeks to reduce risk for dating violence by facilitating progress through the stages of change for using healthy relationship skills; daters are encouraged to use those skills in their dating relationships, and non-daters in their peer relationships, as relationships with peers serve as the foundation for experiences in romantic relationships. For victims of dating violence experiencing fear, the intervention does not focus on healthy relationship skills; instead, it seeks to facilitate progress through the stages of change for keeping oneself safe in relationships.
16059467|NCT02458365|Behavioral|Health In Motion|A 3-session online, multimedia, TTM-based intervention which targets physical activity, screen time, and healthy eating for obesity prevention. Health In Motion sessions were administered following the baseline, 6-month, and 12-month assessments to increase the benefits of study participation for Comparison schools and students.
16059468|NCT02458352|Device|Ultra low dose non-contrast enhanced CT|Non-contrast enhanced CT for CACS and AC using a novel protocol for ultra low dose radiation dose exposure
16059469|NCT02458352|Device|Standard dose non-contrast enhanced CT|Clinically indicated non-contrast enhanced CT for CACS and AC according to routine protocol
16059470|NCT02458339|Procedure|Ommaya Reservoir|Surgical catheter placement into the fourth ventricle of the brain
16059471|NCT02458339|Drug|Methotrexate|4, 6, or 8 mg into fourth ventricle of the brain via the Ommaya Reservoir for 2 days a week for 3 weeks with week 4 is a rest week. Each patient will undergo three cycles.
16059472|NCT02458326|Other|Aerobic training|Treadmill training with proper heart rate for aerobic workout to 20 minutes duration and frequency of three times a week for three months.
16059473|NCT02458326|Other|Control Training|10 minutes of heating on the treadmill with a low speed that does not cause patient effort
16059474|NCT02458313|Drug|DMXB-A|150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks.
16059475|NCT02458313|Other|Placebo|Placebo capsules b.i.d. for 12 weeks
16059476|NCT02458300|Other|Nebulization of hypertonic saline|application of hypertonic saline serum through a mask fogging or a box fogging
16059477|NCT02458300|Other|Prolonged slow expiration technique (PSE)|Passive expiratory aid implemented baby. the child is placed supine on a hard surface. Thoracoabdominal slow manual pressure that begins at the end of a spontaneous and continuous exhalation to residual volume is exercised. Oppose reaches 2 or 3 breaths. Vibrations can accompany the art. The goal is to achieve a greater expiratory volume.
16059478|NCT02458300|Other|Patient coughing Provocation (TP)|Tp is based on the mechanism reflects cough induced by stimulation of the buttons on the wall of the trachea extrathoracic mechanoreceptors. The child is placed supine. A short pressure is done with the thumb on the tracheal conduit (in the sternal notch) at the end of inspiration, or at the beginning of expiration. With the other hand holding the abdominal region we prevent the dissipation of energy and make the explosion tussive more effective. It is done after the PSE.
16059479|NCT02458300|Other|inspiratory maneuver to rhinopharyngeal cleaning DRR|After the inspiratory reflection following the PSE, the TP or crying. At the end of expiratory time the child's mouth is closed with the back of his hand just finished his chest support, raising the jaw and forcing the child to an inspiration with the nose
16059480|NCT02458300|Other|Aspiration of secretions|Suctioning with a probe by a vacuum system installed on the wall.
16059481|NCT02458287|Biological|Bococizumab 150mg|Bococizumab autoinjector (pre-filled pen) combination Product. 150mg every 2 weeks for 10 weeks, subcutaneous injection.
16059482|NCT02458287|Biological|Bococizumab 75mg|Bococizumab autoinjector (pre-filled pen) combination Product. 75mg every 2 weeks for 10 weeks, subcutaneous injection.
16059483|NCT02458287|Biological|Bococizumab 150mg placebo|Bococizumab placebo autoinjector (pre-filled pen) combination Product. 150mg placebo every 2 weeks for 10 weeks, subcutaneous injection.
16059484|NCT02458287|Biological|Bococizumab 75mg placebo|Bococizumab placebo autoinjector (pre-filled pen) combination product. 75mg placebo every 2 weeks for 10 weeks, subcutaneous injection.
16059485|NCT02458274|Other|Dosage of Microparticles (MPs) in broncho-alveolar lavage fluid (BALF)|
16059486|NCT02458248|Behavioral|Sodium Reduction|In addition to usual care, those randomised to the intervention arm will receive specific counseling on behavioural and environmental factors that promote sodium reduction after randomization and at all specified post-randomisation visits, targeting sodium intake of <100mmol/day (<2.3g/day). A research dietitian will develop the specific components of the intervention, based on standardised approaches to education interventions.
16059487|NCT02458235|Drug|azacitidine|40mg/m2 IV/SC daily x 4 days, maximum of 7 cycles at 6 weekly intervals
16059488|NCT02458235|Biological|donor lymphocyte infusion|For patients with cells available for DLI who are in the high risk group and do not have graft-versus-host disease (GVHD), DLI will be adminstered on day 5 of each cycle.
16059489|NCT02458222|Other|language game therapy|participants will take part in game therapy
16059490|NCT02458222|Other|standard therapy|usual clinical care
16059493|NCT02458209|Biological|bococizumab PFP|150 mg bococizumab administered SC in a prefilled pen using drug substance manufactured at Pfizer Andover
16059494|NCT02458196|Drug|Prednisone|Prednisone: started with prednisone alone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, and maintained at 10mg/d to 12 months.
16059495|NCT02458196|Drug|Prednisone and Mycophenolate mofetil|"Prednisone: started with prednisone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, maintained at 7.5mg to 10mg/d to 12 months.
~Immunosuppressive drugs: Mycophenolate mofetil 1g/d-1.5g/d for 6 months and 0.5/d-1.0g/d for 6 months."
16059496|NCT02458183|Biological|DTaP-IPV combination vaccine|0.5-mL IM
16059497|NCT02458183|Biological|DTaP vaccine and IPV vaccine|0.5-mL IM
16059498|NCT02458157|Drug|Furosemide (Furix)|"Loading dose: 40 mg I.V.
~Infusion rate 40 mg/h
~Continued until neutral cumulative fluid balance is achieved (the overall treatment goal) or average negative fluid balance is below 1 ml/kg/h for 8 hours."
16059499|NCT02458157|Other|Continuous renal replacement therapy (CRRT)|"Initiated in case of contraindications or inadequate effect of furosemide.
~Fluid removal is started at 2 ml/kg/h
~The efficacy is evaluated 3 times daily and removal rate increased by 0.5 ml/kg/h if the therapeutic goal is not achieved"
16059500|NCT02458157|Other|Resuscitation|"The physiologic response to fluid removal is monitored with three variables indicating inadequate circulation. These are:
~Mottling beyond the edge of kneecaps
~Hypotension (MAP < 50) resistant to inotropes and vasopressors
~Plasma lactate ≥ 4 mmol/l
~Mottling and MAP are monitored continuously and lactate is measured routinely 4-6 times each day and on clinical indication. If one or more variable is present:
~Fluid removal is paused
~A crystalloid fluid bolus of 250-500 ml is given
~Circulatory status is reevaluated within 30 minutes
~Step 1-3 is repeated until signs of inadequate circulation have been resolved for minimum 1 hour
~Fluid removal is restarted in 25% reduced dose for minimum 4 hours before evaluation of effect."
16059501|NCT02458157|Other|Usual Care|"All interventions are performed at the discretion of the treating physician apart from initiation of renal replacement therapy which is discouraged unless one or more of the following criteria are met:
~Hyperkalaemia (p-K+ > 6 mmol/l)
~Severe metabolic acidosis attributable to AKI (pH < 7.25 and standard base excess < -10 mmol/l) resistant to IV bicarbonate infusion
~Severe respiratory failure with PaO2/FiO2 < 13 kPa and bilateral infiltrates/oedema on the chest x-ray.
~Progressive azotaemia and a blood urea nitrogen (BUN) > 25 mmol/l."
16059502|NCT02458144|Procedure|Total hip arthroplasty|"The minimally invasive anterior approach The patient is in supine position. The femoral neck is exposed in the interval between tensor fasciae latae, glutei medius and minimus muscles laterally, and sartorius and rectus femoris muscles medially. After osteotomy of the neck and extraction of the head the acetabulum is reamed to prepare for cup prosthesis. Following peritrochanteric capsulotomy the externally rotated, adducted and elevated femur is broached.
~The MIS anterolateral approach The MIS anterolateral technique is a modified Watson-Jones Approach. The patient is in supine position. This approach uses the intermuscular plane between the gluteus medius and the tensor fascia latae. After the anterior capsule is excised, a disc of the femoral neck is removed."
16059503|NCT02458131|Behavioral|TEEN HEED|Peer-led workshops will cover behavioral skills including goal setting, self-monitoring, problem solving, contingency management, coping skills, and social support.
16059504|NCT02458118|Drug|Secretin|Secretin 1 IU/kg over 3 min
16059505|NCT02458105|Behavioral|Acceptance & Commitment Therapy|A variant of cognitive behavior therapy focused on acceptance and valued living in the presence of distressing symptoms.
16059506|NCT02458105|Behavioral|Attention|Supportive conversation at a frequency and length corresponding to the experimental condition.
16059507|NCT02458092|Biological|Plasmodium falciparum Malaria Protein 010 (FMP010)|Vaccine antigen is a recombinant protein based on merozoite surface protein-1 (MSP-1) of FVO strain of Plasmodium falciparum, and adjuvant AS01B is a proprietary adjuvant of GSK
16059508|NCT02458092|Biological|Rabipur|Rabipur is a licensed rabies vaccine.
16059509|NCT02458079|Drug|Pentoxiphylline|
16059510|NCT02458079|Drug|Stool microbiota transplantation|
16059511|NCT02458066|Other|IRS: bendiocarb|carbamate insecticide
16059512|NCT02458066|Other|IRS: deltamethrin|Pyrethroid insecticide
16059513|NCT02458053|Behavioral|Attends with partner|The index partner will participate in intervention as a couple with their female counterpart.
16059514|NCT02458053|Behavioral|Couples Skill Training|Participants and their partners will attend a pre session covering topics to assist them in working together to facilitate lifestyle changes.
16059515|NCT02458053|Behavioral|Face to face group sessions|Group sessions will consists of components in traditional weight management programs.
16059516|NCT02458053|Behavioral|Self Monitor|Participants will be instructed to monitor their eating and physical activity behaviors online/mobile application.
16059517|NCT02458053|Other|Notebook|The notebook will consist of behavioral lessons, diet and physical activity plans, and additional resources to assist participants in achieving their behavioral goals.
16059518|NCT02458053|Behavioral|Feedback|Each participant will receive a tailored email providing feedback on their weekly progress.
16059519|NCT02458040|Drug|Drug selected in the study|
16059520|NCT02458027|Dietary Supplement|Hemp Shake|Hemp Protein Shake
16059521|NCT02458027|Dietary Supplement|Hemp Shake|Hemp Protein Shake
16059522|NCT02458027|Dietary Supplement|Soybean Shake|Soybean Protein Shake
16059523|NCT02458027|Dietary Supplement|Soybean Shake|Soybean Protein Shake
16059524|NCT02458027|Dietary Supplement|Control|Non-Protein Shake
16059525|NCT02458014|Biological|Blinatumomab|Given IV
16059526|NCT02458014|Other|Laboratory Biomarker Analysis|Correlative studies
16059527|NCT02458001|Behavioral|SAFFRON stepped care|"Behavioral: SAFFRON stepped care Stepped care (Improving Access to Psychological Therapies, 2012; Richards et al., 2012) adapted for the gynaecological cancer setting to produce a 3-step model including a clinical assessment and treatment algorithm.
~Assessment Algorithm FSFI Interventions
~Level 1:
~Best available self-help literature on psychosexual difficulties after cancer as judged by the project team and two patient advocates.
~Level 2:
~A 3-5 session manualised psycho-educational intervention delivered fortnightly by study trained CNSs with taping and supervision for adherence to protocol and manual.
~Level 3:
~16 weekly session manualised brief psychotherapy adaptation of InterPersonal Therapy, IPT (Interpersonal Psychotherapy for Sexual Adjustment post Gynaecological Cancer, IPT-APGyC)"
16061800|NCT02441946|Drug|Anastrozole|Administered orally
16059528|NCT02457988|Device|Vivify Kit|home telemonitoring devices with vital sign capturing capabilities, i.e. blood pressure, weight, pulse, and specific questionnaires targeted to the cirrhosis diagnosis.
16059529|NCT02457975|Device|670nm PBM|Battery operated, hand-held, 10 cm2 Light Emitting Diode (LED) array designed to deliver 50 mW/cm2 of light for 90 seconds resulting in a light dose of 4.5 Joules/cm2
16059530|NCT02457975|Drug|intravitreous VEGF-inhibitors|Threeintravitreous VEGF inhibitors - aflibercept (Eylea, Regeneron Pharmaceuticals), bevacizumab (Avastin, Genentech), and ranibizumab (Lucentis, Genentech) - are commonly used for the treatment of diabetic macular edema causing vision impairment and have been shown to be beneficial and relatively safe. Study participants in the anti-VEGF group will be treated with intravitreous injections of one of these agents: afibercept (2.0 mg), bevacizumab (1.25 mg) or ranibizumab (0.5 mg) at appropriate intervals as determined by the treating ophthalmologist.
16059531|NCT02457949|Other|Non-synchronized social assistance receipt|Social assistance disbursement outside government cheque issue week
16059532|NCT02457949|Other|cheque divided into two equal disbursements|Social assistance disbursement divided into two equal payments
16059533|NCT02457936|Behavioral|Mindfulness Based Cognitive Therapy|8 weekly meetings in which basic mindfulness and meditation skills are taught, such as breathing meditation, body scan meditation, open awareness meditation, movement meditation, and targeting depression related cognitions and emotions in a mindful manner, as well as awareness exercises, group discussions, and daily home meditation practice routines
16059534|NCT02457923|Other|Mobile phone counselling|i) Data collection and counselling by ASHA using the cell application (App) developed by CommCare Dimagi ii) Mobile phone counselling iii) Routine counselling schedules
16059535|NCT02457910|Other|Biomarker Analysis|Correlative studies
16059536|NCT02457910|Drug|Enzalutamide|Given PO
16059537|NCT02457910|Other|Pharmacological Study|Correlative studies
16059538|NCT02457910|Drug|Taselisib|Given PO
16059539|NCT02457897|Drug|Liothyronine|Oral supplement given every 8 hours
16059540|NCT02457884|Other|Temporal Group|Visual Processing Training
16059541|NCT02457884|Other|Spatial Group|Spatial visual span training
16059542|NCT02457884|Other|Combined Group|Visual processing speed and spatial visual span training
16059543|NCT02457884|Other|Control Group|Leisure reading activities
16059544|NCT02457871|Behavioral|Ecological Nurse Case Management|The Ecological Nurse Case Management (ENCM) intervention allows for individualized case management based on client preferences through mutual goal setting and client choice points, nursing assessments, the nurse's analytic decision-making process and critical thinking, and nursing actions.
16059545|NCT02457858|Drug|Islet isolation using BMX-010|BMX-010 will be used as a supplement in islet isolation process.
16059546|NCT02457845|Biological|G207|Single dose of HSV-1 (G207) infused through catheters into region(s) of tumor defined by MRI
16059547|NCT02457832|Behavioral|Adapted Tango Dancing|Composed of simple steps, tango involves frequent movement initiation and cessation, multi-directional perturbations and varied rhythms. Participants focus on trunk control and stepping strategies, coordination, somatosensory awareness, attention to partner, path of movement, and aesthetics. Sessions will begin with a typical dance class warm-up consisting of breathing, limbering and postural alignment to upbeat music. Novel step elements will be introduced every class period. Those with PD will partner with an individual without PD. After novel step introduction, the instructor will present rhythmic training, which is indispensable to partnered dancing. Participants will learn 'typical' rhythms from tango and Latin dances, based upon the system of quicks (Q) and slows (S), ubiquitously used in ballroom dance training to understand the temporal relationship of movement to music.
16059548|NCT02457832|Behavioral|Behavioral Control (BC) Condition|Group health education sessions adapted to the needs of individuals with PD, about pharmacological management, nutrition, sleep disorders, cognitive deficits, bereavement coping, mobility, balance and home safety.
16059549|NCT02457819|Drug|Dasotraline|Dasotraline 2 mg, 4 mg, 6 mg, once daily, flexibly dosed
16059550|NCT02457806|Drug|Tetracaine HCl 3% and Oxymetazoline HCl 0.05%|Active Spray with deliverable volume of 0.1 mL
16059551|NCT02457806|Drug|Placebo spray|Aqueous solution to deliver 0.1 mL per unit
16059552|NCT02457793|Drug|Cobimetinib|Cobimetinib given concurrently or intermittently with GDC-0994 for 21 consecutive days followed by 7 days off.
16059553|NCT02457793|Drug|GDC-0994|GDC-0994 given for 21 consecutive days followed by 7 days off, along with concurrent or intermittent dosing of cobimetinib.
16059554|NCT02457780|Behavioral|Relaxation Response Resiliency Program (3RP)|The 3RP is designed to decrease psychiatric and physical health symptoms and build resiliency by teaching skills to (1) elicit the relaxation response, (2) decrease stress reactivity and (3) increase social connectedness. Eliciting the relaxation response involves sustained mental focus with an attitude of receptive awareness with strategies aimed at reducing muscle tension, breathing rate, heart rate, and blood pressure. Decreasing stress reactivity involves increasing awareness of the stress response and learning skills to proactively address stress. Increasing connectedness involves skills to promote positive growth, self-efficacy and social support. Other skills and experiential exercises focus on increasing acceptance, optimism, empathy, and appreciation to promote resiliency.
16059555|NCT02457780|Behavioral|Health Enhancement Program (HEP)|The HEP is designed to address comorbid physical and mental health symptoms via psychoeducation, self-monitoring and goal setting techniques. It is an 8 session manualized group intervention which addresses topics including sleep hygiene, nutrition, exercise, working with a healthcare team, and substance use. The program uses a variety of in-session activities to engage participants in discussion related to self-care and wellness principles. Relapse prevention and long-term goal setting are addressed. The program is designed to be implemented by professionals with a background in mental health.
16059556|NCT02457728|Device|LiquiBandFix8|Using LiquiBandFix8 for mesh fixation and peritoneal closure following TAPP repair.
16059557|NCT02457702|Other|Orally administered labeled glycerol|Oral administration of labeled glycerol
16059558|NCT02457689|Biological|GTU®-MultiHIV B Clade Vaccine|The investigational HIV-1 vaccine GTU®-MultiHIV B clade encodes for a MultiHIV antigen (synthetic fusion protein) built up by full-length polypeptides of Rev, Nef, Tat, p17 and p24 with more than 20 Th and CTL epitopes of protease, reverse transcriptase (RT) and gp160 regions of an HAN2 HIV-1 B clade isolate.
16059675|NCT02456909|Drug|Morphine|Morphine will be administered for post-operative pain in both the Cues and Non-Cues groups
16059559|NCT02457689|Other|Sodium chloride BP|For use in prophylactic and replacement therapy, requiring the use of isotonic saline solution.
16059560|NCT02457676|Behavioral|Alert Program for Self-Regulation|"Children attend 12 1.5 hour weekly sessions. Alert uses the analogy of a car engine to help children identify their own self-regulatory behavior. Children learn strategies to regulate their own engine speed in different situations."
16059561|NCT02457663|Procedure|Blood Draw|Blood is to be collected at admission, prior to the 1st operating procedure, once daily for the following 7 consecutive days, at day 15, and at discharge (11 blood draws total). Blood will be taken from IV catheter or routine venipuncture if the catheter is not in place. The blood draw will occur prior to the induction of anesthesia or operating surgical procedure.
16059562|NCT02457650|Drug|Cyclophosphamide|On days -7 through -6, Cyclophosphamide 60mg/kg/day IV will be infused over 60 minutes.
16059563|NCT02457650|Drug|Fludarabine|On days -5 through -1, Fludarabine 25mg/m2/day IV will be infused over 30 minutes.
16059564|NCT02457650|Biological|Anti-NY ESO-1 TCR-transduced T cells|Modified cells will be infused IV over 30 minutes.
16059565|NCT02457637|Other|Standary therapy|Standary therapy for chronic liver disease with ALI and/or AD
16059566|NCT02457624|Behavioral|Education and feedback|Experienced endoscopists will receive education on Kimura-Takemoto classification and feedback for their answers for classification tests.
16059567|NCT02457611|Drug|LDV/SOF|90/400 mg FDC tablet administered orally once daily
16059568|NCT02457598|Drug|Tirabrutinib|Capsules or tablets administered orally
16059569|NCT02457598|Drug|Idelalisib|Tablets administered orally twice daily
16059570|NCT02457598|Drug|Entospletinib|Tablets administered orally
16059571|NCT02457598|Drug|Obinutuzumab|Administered intravenously
16059572|NCT02457585|Drug|remicade (anti tumor necrosis factor inhibitor)|single arm:remicade treatment group
16059573|NCT02457572|Procedure|Valsalva maneuver|Valsalva maneuver was performed after sternotomy with the constant airway pressure of 30cmH2O for 2 breaths duration.
16059574|NCT02457572|Other|Fluid loading|We record the cardiac index values before and after volume expansion with 6ml/kg of balanced crystalloid
16059575|NCT02457559|Drug|Tirabrutinib|Tablets or capsules administered orally
16059576|NCT02457546|Biological|EVICEL Fibrin Sealant|
16059577|NCT02457546|Device|Hydrogel sealant|
16059578|NCT02457533|Behavioral|Lifestyle behavioral. Health plan, telephone support|'Lifestyle behavioral. Health plan, telephone support'
16059579|NCT02457520|Drug|Isotretinoin|ABSORICA® (isotretinoin) capsules 0.5 mg/kg/day for 4 weeks followed by 1.0 mg/kg/day for 16 weeks
16059580|NCT02457507|Dietary Supplement|Vitamin B12|2 tablets
16059581|NCT02457507|Dietary Supplement|Placebo|2 tablets
16059582|NCT02457481|Device|Embryo Culture medium|Two step sequential embryo culture medium system
16059583|NCT02457468|Device|coflex|
16059584|NCT02457442|Drug|Propofol and Remifentanil|High propofol and low remifentanil, changing remifentanil (up-and-down method)
16059585|NCT02457442|Drug|Propofol and Remifentanil|Low propofol and high remifentanil, changing propofol (up-and-down method)
16059586|NCT02457442|Drug|Sevoflurane and Remifentanil|High sevoflurane and low remifentanil, changing remifentanil (up-and-down method)
16059587|NCT02457442|Drug|Sevoflurane and Remifentanil|Low sevoflurane and high remifentanil, changing sevoflurane up-and-down method)
16059588|NCT02457442|Drug|SPR 1|"Triple combination with intermediate propofol and sevoflurane and intermediate remifentanil.
~SPR 1: Changing Propofol for skin incision."
16059589|NCT02457442|Drug|SPR2|"Triple combination with intermediate propofol and sevoflurane and intermediate remifentanil.
~Changing Sevoflurane for skin incision."
16059590|NCT02457429|Device|Experiemental diagnostic procedure: Dx-pH measurement system|"The Dx-pH Measurement system (Dx-pH; Respiratory Technology Corp., San Diego, CA) is a sensitive and minimally invasive transnasal device for detection of aerosolized extra-oesophageal acid reflux in the posterior oropharynx.
~The sterile single use Dx-pH catheter will be passed trans-nasally into the same nostril as the same nostril as the other catheter. The internal pH value of the oesophagus is then continuously measured and recorded onto a small ambulatory device. The 2 catheters are connected to the ambulatory recording devices and recording commences. The duration of the investigation is 24 hours."
16059591|NCT02457429|Other|Peptest assay|A saliva sample of 0.5-1 ml will then be taken for pepsin assay (Peptest). The saliva sample will be drawn into a micro-centrifuge tube (0.5ml) and centrifuged. 80 microlitres is taken from the supernatant layer, vortex mixed, then applied to the assay test strip. The result is obtained after 15 minutes. The saliva sample will then be securely disposed.
16059592|NCT02457429|Other|GORD symptom questionnaire|A validated 7 domain GORD symptom questionnaire (GSQ-YC) to quantify the GORD related symptoms their child suffers with is to be completed prior to any intervention.
16059593|NCT02457416|Other|Peanut|Treatment with peanut in increasing doses until a maintenance dose
16059594|NCT02457403|Device|ROTEM|Assess coagulopathy with ROTEM device compared to conventional laboratory tests. ROTEM will be used on all patients, however, determination of blood products used will be based on patient's randomization group.
16059595|NCT02457403|Other|Conventional Therapy|Assess coagulopathy with conventional laboratory tests (PT/INR, Hemoglobin, Platelet count). Conventional laboratory tests will be obtained on all subjects, however, determination of blood products used will be based on patient's randomization group.
16059596|NCT02457390|Procedure|CE-LUS|"To assess the use of contrast enhanced LUS during robot assisted primary CRC surgery. Does CE-LUS detect any unrecognized liver metastases.
~The patient will get a contrast-enhanced CT scan 3 month after surgery as a control to the CE-LUS procedure."
16059597|NCT02457377|Procedure|laparoscopic cerclage|The vesico-uterine peritoneum is opened & the urinary bladder is dissected downwards . Both needles are passed through the lower uterine tissue medial to uterine vessels on the right & left sides . Then, both needles are passed through the remaining cervical tissue medial to uterosacral ligaments towards the posterior vaginal fornix (on the right & left sides) guided by laparoscopic illumination . When the needles' blunt ends pierce the vaginal vault, the assistant pull them through the posterior vaginal fornix . After trimming of both needles, the Mersilene tape is tied tightly behind the intravaginal segment of the cervix with five knots &
16059767|NCT02456350|Biological|Anti-CD19-CAR transduced T cells|Modified cells will be infused IV over 30 minutes (2-4 days after the last dose of fludarabine).
16059598|NCT02457351|Drug|Roniciclib (BAY 1000394)|"Part 1 of Cycle 1 Cycle 1 Day 1: Single dose 2.5 mg Cycle 1 Day 6: Single dose 2.5 mg Part 2 of Cycle 1 Cycle 1 Day 1: Single dose 2.5 or 5 mg (based on Part 1 data) Cycle 1 Day 6: Single dose 2.5 or 5 mg (based on part 1 data)
~Part 1 & Part 2
~Cycle 2 and subsequent 21-day cycles:
~Day 1-3 of each cycle: 5 mg bid Day 4-7 of each cycle: no dose"
16059599|NCT02457351|Drug|Itraconazole (Sporanox)|Part 1 & Part 2 of Cycle 1 Cycle 1 Day 4: 200 mg bid Cycle 1 Day 5-11: 200 mg qd
16059600|NCT02457338|Dietary Supplement|Bifidobacterium|
16059601|NCT02457325|Drug|Surgery with 2%Articaine first, then Surgery with 4% Articaine|First Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne), Washout (1-2 months), and Second Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne)
16059602|NCT02457325|Drug|Surgery with 4%Articaine first, then Surgery with 2% Articaine|First Intervention (1 day - third molar surgery with infiltration of one cartridge of 4% articaíne), Washout (1-2 months), and Second Intervention (1 day - third molar surgery with infiltration of one cartridge of 2% articaíne)
16059603|NCT02457312|Drug|Letrozole|letrozole 10 mg daily for 7 days before suction evacuation
16059604|NCT02457312|Drug|Placebo|placebo tablets which look identical to the letrozole tablets for 7 days before suction evacuation
16059605|NCT02457299|Procedure|Two Stage Esophagectomy|Patients will undergo laparoscopic staging and ischemic gastric conditioning and pyloric Botox injection 7-10 days prior to an esophagectomy with gastric pull-up reconstruction
16059606|NCT02457299|Procedure|One Stage Esophagectomy|Patients will undergo an esophagectomy with gastric pull-up reconstruction without any preconditioning.
16059607|NCT02457286|Drug|Metformin|Although metformin is FDA approved to treat type 2 diabetes, it is not FDA approved for the treatment of NAFLD and is considered investigational for the purpose of this study.
16059608|NCT02457286|Behavioral|Lifestyle modifications|Recommendations for lifestyle modification will be based on the Diabetes Prevention Program 2002 (26) and will include recommendations for greater than 150 minutes of physical activity weekly, referrals to group and/or individualized sessions with nutritionists and/or lifestyle coaches as well as educational materials
16059609|NCT02457286|Device|Fibroscan device (Echosens)|This study will be incorporating the use of a Fibroscan device (Echosens) at the initial visit and upon completion of the study, which works by measuring shear wave velocity.
16059610|NCT02457273|Drug|TLC 388|40 mg/m2 of TLC 388, given as a 30 (+3) minute intravenous infusion, on Days 1, 8 and 15 of a 28-day cycle until PD, unacceptable toxicity or consent withdrawal occurs.
16059611|NCT02457260|Drug|14 N Sodium Nitrite|oral formulation of sodium nitrite 40 mg three times daily for 4 weeks
16059612|NCT02457247|Drug|Calcichew D3|Calcichew D3 500/400 (Calcium 500 mg/400 IU Vitamin D3) Calcichew D3 500/800 (Calcium 500 mg/800 IU Vitamin D3)
16059613|NCT02457247|Drug|Adcal-D3|Adcal-D3 (Calcium 600mg/400 IU Vitamin D3)
16059614|NCT02457247|Drug|Kalcipos-D|Kalcipos-D (Calcium 500mg/800 IU Vitamin D3)
16059615|NCT02457234|Behavioral|Cultural immersion|The primary intervention was the cultural immersion within CIC. Unique to the Traditions study were culturally-adapted nutrition lessons incorporated into CIC and UDC. CIC had a high cultural dose as the Traditions lessons were implemented within the cultural immersion context of the camp. The UDC had moderate cultural dose from the Traditions lessons only. RSC was without cultural immersion and Traditions lessons or had zero cultural dose.
16059616|NCT02457221|Drug|Tacrolimus capsules|oral
16059617|NCT02457221|Drug|Cyclophosphamide injections|intravenous injection
16059618|NCT02457221|Drug|Prednisone|oral
16059619|NCT02457208|Drug|Isoniazid (H)|
16059620|NCT02457208|Drug|Rifampicin (R)|
16059621|NCT02457208|Drug|Pyrazinamide (Z)|
16059622|NCT02457208|Drug|Ethambutol (E)|
16059623|NCT02457195|Drug|granisetron|Application granisetron transdermal patch preoperatively
16059624|NCT02457182|Other|Mindfulness-based Stress Reduction (MBSR)|
16059625|NCT02457182|Other|Usual medical therapy|
16059626|NCT02457169|Behavioral|Parent Preschool Engagement intervention|This 1-2 session intervention (2-4 hours total) will involve one-on-one session(s) for parents whose children (all of whom have received a diagnosis of ASD through our study) are turning 3 and therefore transitioning from the Early Intervention system to the public school special education system. The intervention will utilize motivational interviewing (MI) principles to equip parents with the skills, knowledge, and clarity of goals necessary to collaborate effectively with school special education staff and teachers, to advocate for their children's needs, and to be empowered to navigate the special education system.
16059627|NCT02457169|Behavioral|Attention Control|The attention control condition is parallel in format (one-on-one between parent with interventionist) and intensity (1-2 sessions, or 2-4 hours total). It involves open-ended interviews with parents about their child's development and plans for school.
16059628|NCT02457156|Procedure|Blumgart Anastomosis|"Trans pancreatic suture U stich incorporating pancreatic parenchyma and jejunal serosa, left loose.
~Pancreatic duct to jejunal mucosa sutures, inserted and tied.
~Trans pancreatic suture U stich brought back through the jejuanl serosa anteriorly, tied."
16059629|NCT02457156|Procedure|Cattell-Warren Anastomosis|"Posterior row of sutures from pancreatic parenchyma to jejunal serosa, inserted and tied.
~Pancreatic duct to jejunal mucosa sutures, inserted and tied.
~Anterior row of sutures from pancreatic parenchyma to jejunal serosa, inserted and tied."
16059630|NCT02457156|Drug|Octreotide|Octrotide (100ug) to be administered on the evening before surgery and then 100ug three times daily on the day of surgery and post operative days 1 - 6.
16059631|NCT02457143|Behavioral|Letter|
16059632|NCT02457143|Behavioral|Phone call|
16059633|NCT02457130|Drug|Ticagrelor|
16059634|NCT02457130|Drug|Clopidogrel|
16059635|NCT02457117|Radiation|CyberKnife Stereotactic Accelerated Partial Breast Irradiation (CK-SAPBI)|Five fraction radiation therapy to the lumpectomy cavity
16059636|NCT02457104|Procedure|Colonoscopy|Patients selected from those undergoing screening colonoscopy. During colonoscopy, stool aspirates and biopsies will be taken from the terminal ileum, cecum, and sigmoid colon.
16059637|NCT02457104|Behavioral|Weight and diet questionnaire|Brief questionnaire outlining weight history, type and dose of PPI, and diet.
16059638|NCT02457091|Behavioral|Resistance exercise|strength training consists of 1-3 sets , 10-15 repetitions of 10 exercises targeting lower body, upper body and core muscle groups
16059639|NCT02457091|Behavioral|Stretching exercise|The stretching condition will consist of 1-3 sets, 30-40 seconds of 12 stretching movements targeting lower body, upper body, and core areas performed 2 days per week.
16059640|NCT02457078|Dietary Supplement|Postnatal Dietary Supplement|Dietary Supplement: docosahexaenoic acid, lutein, and α-tocopherol (vitamin E). 1 capsule per day will be consumed beginning immediately after birth and continuing for 9 months.
16059641|NCT02457078|Dietary Supplement|Control Supplement|Placebo Supplement:soybean oil and α-tocopherol (vitamin E)
16059642|NCT02457065|Behavioral|"Melanoma Survivor plaque"|The investigators give the patients a small 3.5 by 2 inch wooden plaque that celebrates their survival of melanoma and reminds them to engage in skin cancer prevention behaviors.
16059643|NCT02457052|Device|DATP|Medical device allowing a custom sitting to help patients with swallowing disorders
16059644|NCT02457039|Procedure|Dense cranial electroacupuncture stimulation|"DCEAS is a is a novel stimulation mode in which electrical stimulation is delivered on acupoints located on the forehead.
~Six pairs of acupoints are used: Baihui (GV20) and Yintang (EX-HN3), left Sishencong (EX-HN1) and Toulinqi (GB15), right Sishencong (EX-HN1) and Toulinqi (GB15), bilateral Shuaigu (GB8), bilateral Taiyang (EX-HN5), and bilateral Touwei (ST8).
~Disposable acupuncture needles (Hwato®, 0.30 mm in diameter and 25-40 mm in length) are inserted at a depth of 10-30 mm perpendicularly or obliquely into acupoints. Manual manipulation is then conducted to evoke needling sensation, followed by electrical stimulation (ITO ES-160, continuous waves at 2 Hz)."
16059645|NCT02457039|Procedure|Body acupuncture|"Following acupoints are used: Shui-Gou (GV26), Shen-Men (HT7). He-Gu (LI4), Wai-Guan (TE5), Zhong-Wan (CV12), Guan-Yuan (CV4), Zu-San-Li (ST36), Feng-Long (ST40) and San-Yin-Jiao (SP6).
~Disposable acupuncture needles (Hwato®, 0.30 mm in diameter and 25-40 mm in length) are inserted at a depth of 10-30 mm perpendicularly or obliquely into acupoints. Manual manipulation is then conducted to evoke needling sensation. No electrical stimulation is delivered."
16059646|NCT02457039|Procedure|Least acupuncture stimulation|The acupoints chosen are less related to the treated syndromes based on Traditional Chinese Medicine (TCM) theory; the number of acupoints used and the intensity of electrical stimulation are also lower than the comprehensive acupuncture regimen. The following 6 acupoints will be used in LAS control: bilateral Tong-Tian (GB17), bilateral Shou San-Li (LI10) and bilateral Fu-Yang (BL59). Electrical stimulation will be only performed on bilateral Tong-Tian (GB17) and the intensities are adjusted to a level at which patients just start feeling the stimulation.
16059647|NCT02457039|Drug|Cytoxan-containing chemotherapy regimens|"Each subject shall receive oral administration or venous injection or both with adjuvant or neoadujuvant chemotherapy regimens, as decided by clinical oncologist.
~In clinical practice, the most commonly used Cytoxan-containing regimens include but are not limit to:
~AC (x4) [Adriamycin + Cytoxan], TC (x4) [Taxotere + Cytoxan], AC-P (4+4) [Adriamycin + Cytoxan + Paclitaxel], TAC (x6) [Taxotere + Adriamycin + Cytoxan], or AC-PH (4+4) [Adriamycin + Cytoxan + Paclitaxel + Herceptin]."
16059648|NCT02457026|Drug|Aflibercept|Aflibercept is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1.
16059649|NCT02457026|Drug|Triamcinolone Acetonide|Triamcinolone Acetonide is a synthetic corticosteroid indicated for treatment of ocular inflammatory conditions, uveitis, sympathetic ophthalmia, and temporal arteritis.
16059650|NCT02457026|Drug|Verteporfin|Verteporfin is a benzoporphyrin derivative, and is a medication used as a photosensitizer for photodynamic therapy.
16059651|NCT02457013|Device|HFNC|Hygh flow nasal canula HFNC
16059652|NCT02457013|Device|nCPAP|nasal nCPAP
16059653|NCT02456987|Device|Samsung Gear|Intervention arm will be exposed to a series of virtual reality experiences using the Samsung Gear hardware one time during their inpatient stay at Cedars-Sinai.
16059654|NCT02456974|Procedure|blood sampling in patients receiving amoxicillin-clavulanate as part of routine clinical care|
16059655|NCT02456974|Procedure|blood sampling in patients receiving piperacilline-tazobactam as part of routine clinical care.|
16059656|NCT02456974|Procedure|blood sampling in patients receiving vancomycin as part of routine clinical care.|
16059657|NCT02456974|Procedure|blood sampling in patients receiving teicoplanin as part of routine clinical care.|
16059658|NCT02456974|Procedure|blood sampling in patients receiving meropenem as part of routine clinical care.|
16059659|NCT02456974|Procedure|blood sampling and urine smapling in patients receiving ciprofloxacin as part of routine clinical care.|
16059660|NCT02456974|Procedure|blood sampling in patients receiving amikacin as part of routine clinical care.|
16059661|NCT02456961|Procedure|iontophoresis of riboflavin|
16059662|NCT02456961|Procedure|epithelium-off|
16059663|NCT02456961|Procedure|Corneal collagen crosslinking|Standard surface UVA irradiation (370 nm, 3 mW/cm2; UFalink, Russian Federation) was then applied at a 5-cm distance for 30 minutes. During UVA exposure, hypotonic riboflavin drops were continued every 2 minutes.
16059664|NCT02456961|Device|galvanizator, Potok-1|Device for providing iontophoresis procedure
16059665|NCT02456961|Drug|Dextralink|Riboflavin 0,1% + Dextran T-500
16059666|NCT02456961|Drug|Riboflavin 0,1%|
16059667|NCT02456961|Device|UFalink|device for UVA irradiation - providing UVA light - 370 nm, 3 mW/cm2
16059668|NCT02456948|Drug|Minocycline|6 weeks 200mg/day Minocycline add-on
16059669|NCT02456948|Drug|Placebo|6 weeks Placebo add-on
16059670|NCT02456935|Drug|CJ-12420 100 mg QD|CJ-12420 100 mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose erosive esophagitis is not endoscopically healed at Week 4, subjects will receive additional 4 week treatment of CJ-12420 100 mg.
16059671|NCT02456935|Drug|Esomeprazole 40 mg QD|Esomeprazole 40 mg tablets will be orally administered, once daily, for up to 8 weeks. For subjects whose erosive esophagitis is not endoscopically healed at Week 4, subjects will receive additional 4 week treatment of Esomeprazole 40 mg.
16059672|NCT02456922|Device|Harmony 1 Sensor|Use of Harmony 1 Sensor over 10 days in arm and abdomen and used with the Guardian Mobile App in subjects aged 2-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.
16059673|NCT02456909|Device|Patient-Controlled Analgesia pump with Cues|The end of the lockout period will be cued via the PCA pump
16059674|NCT02456909|Device|Patient-Controlled Analgesia pump without Cues|The PCA pump will be programmed such that no cues will be provided to the end of the lockout period.
16063112|NCT02432014|Behavioral|PMTO Individual home-based|
16059676|NCT02456896|Drug|Oxcarbazepine|After baseline assessments, patients in test group will be prescribed Tab. Oxcarbazepine (600mg/daily in two divided dose for 1 week followed by 900mg/daily in two divided dose for next 3 weeks).
16059677|NCT02456883|Drug|gilteritinib|oral
16059678|NCT02456883|Drug|14C-labeled gilteritinib|oral
16059679|NCT02456870|Other|Overfeeding|Consumption of 40% excess calories for 7 consecutive days
16059680|NCT02456857|Biological|Bevacizumab|Given IV
16059681|NCT02456857|Drug|Everolimus|Given PO
16059682|NCT02456857|Other|Laboratory Biomarker Analysis|Correlative studies
16059683|NCT02456857|Drug|Pegylated Liposomal Doxorubicin Hydrochloride|Given IV
16059684|NCT02456844|Drug|Montelukast, Flurbiprofen, Midazolam, Digoxin, Pravastatin and BMS-986142|"Montelukast 10-mg tablet: On Days 1 and 8,Single oral dose
~Flurbiprofen 50-mg tablet: On Days 1 and 8,Single oral dose
~Midazolam syrup 2.5 mL × 2 mg/mL (5 mg): On Days 1 and 8,Single oral dose
~Digoxin (Lanoxin®) 0.25 mg tablet: On Days 1 and 8,Single oral dose
~Pravastatin 40-mg tablet: On Days 1 and 8,Single oral dose
~BMS-986142: On Days 6 through 12."
16059685|NCT02456844|Drug|Methotrexate, Leucovorin and BMS-986142|"Methotrexate (MTX) single oral dose of 3 × 2.5-mg tablet (Days 1 and 8)
~Leucovorin single oral dose of 15-mg tablet (Days 2 and 9; 24 hours after MTX administration)
~BMS-986142 on Days 6 through 10."
16059686|NCT02456831|Other|Experimental Infant Formula 1|method A phytate reduction and 5% protein hydrolysis
16059687|NCT02456831|Other|Experimental Infant Formula 2|method A phytate reduction and 10% protein hydrolysis
16059688|NCT02456831|Other|Experimental Infant Formula 3|method B phytate reduction and 5% protein hydrolysis
16059689|NCT02456831|Other|Active Comparator: Control Infant Formula|Ready-to-Feed (RTF) Soy Infant Formula
16059690|NCT02456805|Other|Infant Formula 1|Feed ab libitum
16059691|NCT02456805|Other|Infant Formula 2|Feed ab libitum
16059692|NCT02456792|Procedure|IVF|Women will undergo one IVF cycle
16059693|NCT02456792|Procedure|LOD|Women will be subjected to LOD followed by ovarian stimulation if spontaneous ovulation does not occur within 2 months
16059694|NCT02456779|Other|in vitro diagnostic test (Peptest)|saliva samples obtained and tested in laboratory conditions for the presence of pepsin using Peptest
16059695|NCT02456779|Other|Questionnaire|all recruited subjects to complete the RDQ as a determinant of inclusion criteria
16059696|NCT02456779|Other|Questionnaire|control subjects to complete RSI as a determinant of inclusion criteria
16059697|NCT02456766|Device|FibroTouch|
16059698|NCT02456766|Procedure|Liver Biopsy|
16059699|NCT02456753|Device|trans-perineal ultrasonography|Assesment of the fetal head-perineum distance via a trans-perineal ultrasonography
16059700|NCT02456740|Drug|Erenumab|Administered by subcutaneous injection once a month
16059701|NCT02456740|Drug|Placebo|Administered by subcutaneous injection once a month
16059702|NCT02456727|Procedure|Group/Community Acupuncture|Acupuncture treatment in a group setting.
16059703|NCT02456727|Procedure|Individual Acupuncture|Acupuncture treatment in an individual setting.
16059704|NCT02456714|Drug|FOLFIRINOX|
16059705|NCT02456701|Biological|KTN3379|IV every 2 weeks
16059706|NCT02456701|Drug|vemurafenib|960 mg po bid
16059707|NCT02456688|Drug|Imrecoxib|
16059708|NCT02456675|Drug|INCB040093 Monotherapy|INCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food.
16059709|NCT02456675|Drug|INCB040093|INCB040093 sustained release (SR) tablets will be administered orally twice daily (BID) without regard to food.
16059710|NCT02456675|Drug|itacitinib|The dose of itacitinib will be given orally once daily (QD).
16059711|NCT02456662|Drug|Ondansetron|8mg PO ondansetron 30 minutes prior to 200mg PO doxycycline
16059712|NCT02456662|Drug|Placebo|placebo (identical to study medication- ondansetron) PO 30 minutes prior to 200mg PO doxycycline
16059713|NCT02456649|Device|MarginProbe|Intraoperative MarginProbe use as adjunct to standard practice MarginProbe will be used on the lumpectomy specimen within 20 minutes of excision, prior to specimen Xray or gross pathology evaluation. This may take up to 5 minutes. MarginProbe will indicate a positive or negative reading for each of the 6 circumferential margins, and the results will be recorded. Any margins determined by to < 5-10 mm by specimen Xray or gross pathology examination will be re-excised. In addition, any additional margins not already identified as < 5-10 mm, but identified as positive by MarginProbe will be re-excised where feasible.
16059714|NCT02456636|Behavioral|Fee-for-Service Model (FFS, In clinic individual visits)|To be performed by participant's doctor or other healthcare professional in their doctor's office.
16059715|NCT02456636|Behavioral|Patient Centered Medical Home (PCMH, In clinic group visits)|To be performed by a registered dietitian, a nurse or other healthcare professional in their local setting.
16059716|NCT02456636|Behavioral|Disease Management (DM, Phone group visits)|To be performed by obesity treatment specialists with relevant graduate training and experience with weight loss counseling via telephone.
16059717|NCT02456623|Behavioral|Intervention|Home-based session targeting the parent
16059718|NCT02456623|Behavioral|Attention Control|Attention condition with newsletters and support phone calls
16059719|NCT02456610|Biological|CMV/EBV specific CTLs|Patients will receive approximately 1x10e6 CTLs/kg as a single infusion via IV injection and may receive 1 to 8 additional infusions at intervals of one week.
16059720|NCT02456597|Drug|lidocainhydrochlorid|Lidocaine injected through the novel Catheter
16059721|NCT02456597|Drug|Isotonic Saline|Isotonic saline injected through the novel Catheter
16059722|NCT02456584|Drug|DMPA 150|injectable contraceptive
16059723|NCT02456584|Drug|DMPA 300|injectable contraceptive
16059724|NCT02456584|Drug|DMPA 104|injectable contraceptive
16059725|NCT02456571|Device|CTC biomarker expression prevalence|
16059726|NCT02456558|Drug|Intravenous deferiprone|In Cohort 1, the subjects who were randomized to get active product will receive deferiprone at a dose of 1.5 g per infusion, and if there are no significant safety concerns, the subjects in Cohort 2 who were randomized to get active product will receive it a a dose of 2 g per infusion.
16059727|NCT02456558|Drug|Placebo|In both cohorts, the subjects who were randomized to get placebo will receive an infusion of placebo solution that is equal in volume to that of the active product.
16063113|NCT02432014|Behavioral|PMTO Individual clinic-based|
16059728|NCT02456545|Other|≥ 1 potential risk factor for BD|exposure to ≥ 1 potential risk factors for BD (e.g. (sub)threshold affective symptomatology, anxiety, sleep disturbances, family history, episodic substance misuse)
16059729|NCT02456545|Other|depressive syndrome|in- and outpatients with depressive syndrome
16059730|NCT02456545|Other|ADHD|in- and outpatients with ADHD
16059731|NCT02456532|Drug|placebo|
16059732|NCT02456532|Drug|Zolpidem CR|
16059733|NCT02456532|Drug|Eszopiclone|
16059734|NCT02456519|Other|PaedQoR-15 questionnaire|Children/ young people and one parent/ guardian will complete the questionnaire before and after general anaesthesia for surgery or diagnostic imaging.
16059735|NCT02456506|Radiation|Hyperfractionated IMRT|
16059736|NCT02456506|Radiation|Conventional Fraction IMRT|
16059737|NCT02456480|Drug|CLS001|topical gel
16059738|NCT02456480|Drug|Vehicle|topical gel
16059739|NCT02456454|Drug|Risperidone|Liquid risperidone
16059740|NCT02456454|Drug|Valproic Acid|Liquid valproic acid
16059741|NCT02456454|Drug|Placebo|
16059742|NCT02456441|Other|Intervention group|"The device current generator TENS used was  Neurodyn Portable Tens / Fes  of IBRAMED brand. Two self-adhesive electrodes, one immediately behind the medial malleolus and the other 10 cm above will be used. Through a chain of 1Hz, the aim is to correctly identify the tibial nerve. This position is confirmed with the rhythmic movement of the finger flexion. The frequency is then changed to 10Hz, the pulse width set at 200 microseconds and adjusted according to the intensity threshold for each patient, below motor threshold. This current generator also has a device, the VIF (variation in intensity and frequency) that aims to ease the accommodation of sensory receptors and enhance its effects. The application time is 30 minutes"
16059743|NCT02456441|Other|Placebo group|The placebo group received an active current for 15 seconds by means of an apparatus also IBRAMED brand externally similar to that used in GI. Two self-adhesive electrodes, one immediately behind the medial malleolus and the other 10 cm above will be used.The application time for GP also was 30 minutes .
16059744|NCT02456428|Drug|DPP-4 inhibitors|Current exposure to DPP-4 inhibitors (ATC A10BH, A10BD07-A10BD13) will be defined as a prescription duration plus a 30-day grace period (to account for non-adherence and the biological half-lives of these drugs) that overlaps with the index day.
16059745|NCT02456428|Drug|GLP-1 analogs|Current exposure to GLP-1 analogs (ATC A10BX04, A10BX07) will be defined as a prescription duration plus a 30-day grace period (to account for non-adherence and the biological half-lives of these drugs) that overlaps with the index day.
16059746|NCT02456428|Drug|Insulins|Current exposure to insulin (ATC A10A) will be defined as any use of insulin between base cohort entry and the index day.
16059747|NCT02456428|Drug|Biguanides|Current exposure to biguanides (ATC A10BA) will be defined as a prescription duration plus a 30-day grace period (to account for non-adherence and the biological half-lives of these drugs) that overlaps with the index day.
16059748|NCT02456428|Drug|Sulfonylureas|Current exposure to sulfonylureas (ATC A10BB or A10BC) will be defined as a prescription duration plus a 30-day grace period (to account for non-adherence and the biological half-lives of these drugs) that overlaps with the index day.
16059749|NCT02456428|Drug|Thiazolidinediones|Current exposure to thiazolidinediones (ATC A10BG) will be defined as a prescription duration plus a 30-day grace period (to account for non-adherence and the biological half-lives of these drugs) that overlaps with the index day.
16059750|NCT02456428|Drug|Alpha-glucosidase inhibitors|Current exposure to alpha-glucosidase inhibitors (ATC A10BF) will be defined as a prescription duration plus a 30-day grace period (to account for non-adherence and the biological half-lives of these drugs) that overlaps with the index day.
16059751|NCT02456428|Drug|Meglitinides|Current exposure to meglitinides (ATC A10BX02, A10BX03) will be defined as a prescription duration plus a 30-day grace period (to account for non-adherence and the biological half-lives of these drugs) that overlaps with the index (event)day.
16059752|NCT02456415|Device|K-MET™ Bioresorbable Bone screw|The biodegradable screw inserted into bone with an appropriate driver is slowly degraded and is completely degraded after completion of bone union and absorbed into the body. The screw is indicated for fixing damaged bone.
16059753|NCT02456402|Device|Drug Coated Balloon|If post balloon angioplasty FFR is more than 0.80, either DCB treatment or BMS implantation will be carried out based on randomization of 1:1. DCB (SeQuent Please paclitaxel-coated balloon catheter, B. Braun, Melsungen, Germany) will be applied at the predilated lesions. PCB will be delivered rapidly and inflated for 60 seconds with nominal pressure.
16059754|NCT02456402|Device|Bare Metal Stent|BMS (Vision®) will be applied at the predilated lesions after angiographic confirmation of the target lesion.
16059755|NCT02456389|Other|Preoperative risk stratification|Preoperative risk-prediction tool based on patient demographics/co-morbidity and planned procedure
16059756|NCT02456389|Other|Postoperative risk stratification|Postoperative risk-prediction tool based on intraoperative variables
16059757|NCT02456389|Other|Risk-based, escalating levels of care|Postoperative observation in regular unit vs. telemetry unit vs. stepdown unit vs. ICU
16059758|NCT02456389|Other|Risk-based, escalating levels of monitoring|Varying frequencies of vital signs monitoring Varying use of telemetry, pulse oximetry, and early warning system
16059759|NCT02456389|Other|Risk-based, escalating levels of co-management|Varying use of Hospitalist co-management
16059760|NCT02456389|Other|Standard postoperative care|Routine postoperative care, as medically indicated
16059761|NCT02456376|Procedure|Sensory Integration Testing|Investigate how sensory information are integrated during upright stance when visual and body senses are challenged in a virtual reality environment
16059762|NCT02456376|Procedure|SR stimulation & Sensory integration testing|Use SR stimulation to improve sensory integration when visual and body senses are challenged in a virtual reality environment
16059763|NCT02456363|Biological|TNF alpha|Depending on patient need to use different TNF alpha
16059764|NCT02456363|Drug|NSAIDs and sulfasalazine|randomized case, combine with use of NSAIDs(-/+) and sulfasalazine(-/+)
16059765|NCT02456350|Drug|Fludarabine|On days -5 through -3, Fludarabine 30mg/m2 IV will be infused over 30 minutes.
16059766|NCT02456350|Drug|Cyclophosphamide|On days -5 through -3, Cyclophosphamide 300mg/m2 IV will be infused over 60 minutes followed by fludarabine.
16059933|NCT02455050|Drug|Genteal® Lubricant Gel Drops|1 to 2 drops of Genteal® Lubricant Gel Drops in each eye.
16059768|NCT02456337|Device|Mucograft|Coronally advanced flap associated to Xenogenous collagen matrix graft (mucograft) for the treatment of gingival recessions Miller Class I or II.
16059769|NCT02456337|Device|Emdogain|Coronally advanced flap associated to Enamel Matrix Derivative (Emdogain) for the treatment of gingival recessions Miller Class I or II.
16059770|NCT02456337|Procedure|Coronally Advanced flap|Coronally advanced flap for the treatment of gingival recessions Miller Class I or II.
16059771|NCT02456324|Device|PICS-AF Device|This is a specialized closure system for anorectal fistulas that is sphincter sparing
16059772|NCT02456324|Device|Historical Controls Treated with Commercially Available Fistula Plugs|These are patients previously treated with commercially available fistula plugs.
16059773|NCT02456311|Device|HARMONIC ACE+7|Pulmonary artery sealing with Harmonic Ace+7 in open lobectomy in humans
16059774|NCT02456298|Behavioral|Standard FA+FCT|Standard Functional Analysis and Functional Communication Training
16059775|NCT02456298|Behavioral|Pragmatic FA+FCT|Pragmatic Functional Analysis and Functional Communication Training
16059776|NCT02456285|Procedure|Primary/Bowel-first Surgery|Patients undergoing primary/bowel-first surgery as part of a staged curative procedure. The liver metastases will be resected in a second planned operation.
16059777|NCT02456285|Procedure|Liver-first surgery|Patients undergoing liver-first surgery as part of a staged curative procedure. The colorectal primary will be resected in a second planned operation.
16059778|NCT02456285|Procedure|Synchronous resection surgery|Patients undergoing a synchronous colorectal primary resection and liver resection in a single operation.
16059779|NCT02456285|Procedure|No surgery|Patients who have no surgery.
16059780|NCT02456272|Device|External hearing aid|The external hearing aid (monaural) with an auditory prosthesis contour type, brand PHONAK type Bolero Q70 will be provided to the patients during a minimum of 2 months.For reasons of standardization and comparability of results, only one type of prosthesis (medium-high range) will be provided. The settings will be performed by audiologists of ENT service during the inclusion visit.
16059781|NCT02456272|Procedure|Otosclerosis surgery|Surgical restoration of the columellar effect consists of the intraoperative verification of the stapedo-vestibular ankylosis which provides diagnostic. Then a stapedotomy (laser or Ototool°) is performed and partial ossicular prosthesis s inserted between stapedotomy and the long process of the incus.
16059782|NCT02456259|Procedure|Neck cannula insertion|Neck cannula insertion is necessary for establishing of cardiopulmonary bypass for Minimally Invasive Cardiac Surgery. It is routine procedure for this type of cardiac surgery.
16059783|NCT02456246|Procedure|FLT-PET|Positron emission tomography scan using the 18f-FLT (3'deoxy-3'-fluorothymidine) tracer
16059784|NCT02456233|Procedure|Conventional AF Ablation with PVI|Trigger Based Ablation for AF, using Pulmonary Vein Isolation (PVI) alone
16059785|NCT02456233|Procedure|FIRM-guided ablation plus PVI|Substrate ablation for AF, via ablation of rotors and focal sources. Conventional (PVI) ablation will also be performed.
16059786|NCT02456220|Device|Herbst appliance|Group treated with conventional Herbst appliance for mandibular advancement during orthopedic treatment.
16059787|NCT02456207|Drug|SCT400|
16059788|NCT02456207|Drug|Rituximab|
16059789|NCT02456194|Device|Calcium Sulfate + Antibiotics + Internal Fixation|STIMULAN Rapid Cure, mixed with antibiotic, and prepared in bead form. Must be used in conjunction with internal fixation. Choice of antibiotic is left to the surgeon's discretion.
16059790|NCT02456181|Behavioral|JumpMath|
16059791|NCT02456155|Procedure|placing nasal jejunal tube with ultrasound|bedside placing nasal jejunal tube with ultrasound confirmation versus placing endoscopically
16059792|NCT02456155|Procedure|placing nasal jejunal tube endoscopically|
16059793|NCT02456142|Drug|caudal bupivacaine|
16059794|NCT02456142|Drug|intravenous morphine|
16059795|NCT02456129|Drug|Vilaprisan (BAY1002670)|single oral doses of 4 mg tablet Vilaprisan, administered once without the comedication of ITZ (period 1) and once with the comedication of ITZ (period 2)
16059796|NCT02456129|Drug|[14C] Vilaprisan|an intravenous microtracer dose of [14C]Vilaprisan administered together with the 1st single oral dose of Vilaprisan
16059797|NCT02456129|Other|Itraconazole(ITZ)|Itraconazole(ITZ) 200 mg as solution, once daily for 14 days
16059798|NCT02456116|Device|acupuncture/PCA/NSAID|"standard program with defined points:
~Ear acupuncture needles bitten once (day 0-5)
~Body acupuncture, once a day 20 minutes (day -1/ 0/ 2/ 4), depth of the prick 0.5 - 1 cm, with DeQI feeling/sensation is released"
16059799|NCT02456116|Device|sham acupuncture/PCA/NSAID|"standard program with defined points:
~Ear acupuncture needles bitten once (day 0-5)
~Body acupuncture, once a day 20 minutes (day -1/ 0/ 2/ 4), depth of the prick 0.5"
16059800|NCT02456116|Other|PCA/NSAID|standard boli of morphine by pressing a button of PCA
16059801|NCT02456103|Drug|Ataluren|Ataluren will be provided as a vanilla-flavored powder to be mixed with water or milk.
16059802|NCT02456077|Behavioral|Multimodal Vaccine Program|Efforts will be made to collaborate with pediatric and family medicine offices to utilize a multimodal intervention to improve adolescents' HPV immunization rates. As part of the overall intervention, four intervention strategies will be used: 1) a tailored website, iVac -HPV , 2) Motivational Interview Training for providers, 3) HPV Fact Sheets and 4) The Decision Aid for HPV Vaccines
16059803|NCT02456064|Behavioral|Lifestyle counseling|"Group medical visits
~Telephone medical consultations
~Expert patient
~Training workshops"
16059804|NCT02456038|Drug|Asfotase Alfa (ALXN1215)|
16059805|NCT02456025|Drug|Topical tacrolimus|Topical tacrolimus 0.01% twice daily for one month
16059806|NCT02456012|Drug|oral esomeprazole 20 mg twice daily|for 36 weeks
16059807|NCT02456012|Drug|oral esomeprazole 20 mg once daily|for 36 weeks
16059808|NCT02455999|Drug|SYL1001|SYL1001 eye drops dose C administration for 10 consecutive days
16059809|NCT02455999|Drug|SYL1001|SYL1001 eye drops dose D administration for 10 consecutive days
16059810|NCT02455999|Drug|Placebo|Placebo eye drops administration for 10 consecutive days
16059811|NCT02455986|Behavioral|The StepSmart Challenge|A six month pedometer based intervention designed to increase Physical Activity in school children
16059853|NCT02455609|Procedure|intrathecal drug administration|pre-emptive intrathecal administration of analgesic medications for control of postoperative pain.
16059854|NCT02455609|Drug|Dexmedetomidine|
16059812|NCT02455973|Behavioral|Lifestyle modification and cardiovascular risk|Group meetings will be performed in the presence of a member of the nursing staff, physiotherapy, nutrition and psychology. The meetings are weekly, lasting 1 hour and 45 minutes. In the first 1 hour and 15 minutes will be addressed health issues related to lifestyle modification (self-care, healthy eating and physical activity) using the fundamentals of motivational interviewing technique. All topics will be focused on the major cardiovascular risk factors considered modifiable.Likewise, it is envisaged to include a time of physical activity (30 minutes) oriented in conjunction with the research team. Run in: There will be a meeting with the parents in order to inform them about the participation of children in the program and guide them about the procedures of the research protocol.
16059813|NCT02455973|Behavioral|Health Education|The meetings will be weekly with 45 minutes duration on a schedule of lectures about cardiovascular risk
16059814|NCT02455960|Dietary Supplement|L-arginine|Comparison of the efficacy of L-arginine 3 grams for days versus placebo in contrast induced AKI prevention
16059815|NCT02455960|Dietary Supplement|Placebo|
16059816|NCT02455947|Other|Inquiry Based Stress Reduction (IBSR)|During a 12-week intervention program, participants will be encouraged to identify and inquire their stressful thoughts.All the sessions were standardized according to a training manual, and were assessed after each session for maintaining consistency in the program.
16059817|NCT02455934|Dietary Supplement|D-allulose|Eligible subjects will come for visit 1 to consume varying dose of D-allulose with sucrose beverage with 1 of 5 beverages in a random order which will be blinded for both subjects and investigators. They will have to do 24-hour dietary record a day prior to each visit. Subjects have to be abstained from energy diet within 8 hours prior to each visit. Venous blood samples will be collected 6 mL for measurement of FPG and insulin before taking any study product. Subjects have to drink all within 1 minute. Blood samples will be drawn again 6 mL at 30, 60, 90 and 120 min after consumption for measurement of PG and insulin. Every subject will be asked to come back to finish OSTT with 5 study products in a random order, each at 7 days or >5 days and <12 days apart.
16059818|NCT02455921|Drug|neostigmine - atropine|Efficacy, safety and effect on cognitive and behavioural function
16059819|NCT02455921|Drug|Sugammadex|Efficacy, safety and effect on cognitive and behavioural function
16059820|NCT02455908|Drug|Proleukin®|
16059821|NCT02455895|Device|iLid Cleanser|Application of iLid Cleanser to reduce bacterial load on the lid and lash margins
16059822|NCT02455869|Drug|SRP and Placebo gel|After SRP, placebo gel was delivered subgingivally into the pocket
16059823|NCT02455869|Drug|SRP and Atorvastatin|After SRP, Atorvastatin gel was delivered subgingivally into the pocket
16059824|NCT02455869|Drug|SRP and Alendronate|After SRP, Alendronate gel was delivered subgingivally into the pocket
16059825|NCT02455856|Drug|JNJ-42847922|Participants will receive single dose of 5 milligram (mg) JNJ-42847922 as 5 mg/milliliter [mL] oral solution on Day 1 and Day 6.
16059826|NCT02455856|Drug|Itraconazole|Participants will receive single dose of itraconazole as 200 mg (2*100 mg capsule) from Day 2 to Day 6.
16059827|NCT02455843|Other|Microwave ablation|Patients assigned to the combination group will be treated with microwave in the primary tumor site
16059828|NCT02455830|Biological|Autologous cord blood cell therapy|The neonates receive their own non-cryopreserved volume- and red blood cell-reduced cord blood cells. The cord blood cells are divided into 3 doses and intravenously infused at 12-24, 36-48, and 60-72 hours after the birth.
16059829|NCT02455804|Device|Stenting procedure|All subjects will be treated with the NIRxcell Stent System and followed at 30 days, 9 months and 1, 2 and 3 years post-index stenting procedure. An unscheduled follow up may be conducted as clinically warranted.
16059830|NCT02455791|Procedure|Ultrasound-Guided Biopsy|Ultrasound-guided biopsy of tumor site. A needle is inserted into the affected area using an ultrasound to collect cells or tissue from a tumor mass. Two (2) types of samples collected.
16059831|NCT02455778|Dietary Supplement|Cinnamon|
16059832|NCT02455778|Dietary Supplement|Placebo|
16059833|NCT02455765|Other|Rice and Amino Acid mixtures|Rice and amino acid mixture
16059834|NCT02455752|Procedure|LE-TME|Retroperitoneal approach for total mesorectal excision
16059835|NCT02455739|Other|chewing gum|postoperative gum chewing to improve gastrointestinal function
16059836|NCT02455726|Dietary Supplement|Magnesium oxide|Oral magnesium oxide 300 mg twice a day
16059837|NCT02455726|Dietary Supplement|Fructose|Oral fructose 10 g twice a day
16059838|NCT02455726|Drug|Oxycodone|Oxycodone hydrochloride 5 mg at 8 am
16059839|NCT02455726|Drug|Pregabalin|Pregabalin 25 mg at 8 pm
16059840|NCT02455713|Device|PEEP and PIP|Changing ventilator settings and measuring oxygen delivery and cardiac output
16059841|NCT02455700|Device|Interproximal Enamel Reduction|removal of enamel between lower incisor teeth as part of orthodontic treatment plan to achieve the aims of treatment
16059842|NCT02455687|Drug|Hi-dose iv MgSO4|
16059843|NCT02455687|Drug|Nebulized budesonide|
16059844|NCT02455687|Drug|Std-dose iv MgSO4|
16059845|NCT02455687|Drug|Nebulized normal saline|
16059846|NCT02455661|Device|TR Band (TM)|
16059847|NCT02455661|Device|AngioSeal|
16059848|NCT02455661|Device|StarClose|
16059849|NCT02455648|Procedure|ESD/EMR plus Cell Sheet|"Patients receive ESD/EMR plus CellSheet:
~Autologous oral mucosa/buccal-derived epithelial cells, cultured on temperature-sensitive membrane (Cell Sheet) that are inserted 2 weeks later on the occasion of the ESD or EMR"
16059850|NCT02455648|Procedure|ESD/EMR|"only ESD/EMR: Autologous oral mucosa/buccal-derived epithelial cells, cultured on temperature-sensitive membrane (Cell Sheet) but NOT used for insertion in the patient during/after ESD/EMR two weeks later"
16059851|NCT02455635|Procedure|office hystroscopy|Office hysteroscopythrough vaginoscopic approach was done in gynecology out-patient clinic using a 4 mm endoscopic sheath & 30 ᵒ endoscopic camera with saline distension medium using 90-100 mmHg pressure
16059852|NCT02455622|Drug|Elaprase for intravenous (IV) infusion|Patients enrolled in this study will receive once-weekly IV infusions of Elaprase at a dose of 0.5 mg/kg and will be followed for a minimum of 5 years after initiation of Elaprase treatment, or until they reach their 10th birthday, whichever is longer.Height and weight data from HOS will be utilized in the Primary Growth Analysis for this study.
16059855|NCT02455609|Drug|ketamine|
16059856|NCT02455609|Drug|Bupivacaine|
16059857|NCT02455596|Drug|Recombinant anti-tumor and anti-virus protein for injection (Novaferon)|Recombinant anti-tumor and anti-virus protein for injection, 10μg, im, 3 times for first week,followed by 20μg for two weeks, and followed a maintenance dose of 30μg, the frequency of administration is three times per week.
16059858|NCT02455583|Behavioral|Project AIM (Adult Identity Mentoring)|Project AIM consists of 14 sessions that are delivered twice a week. Each session is 40 minutes long.
16059859|NCT02455570|Other|No intervention|No intervention
16059860|NCT02455557|Other|Laboratory Biomarker Analysis|Correlative studies
16059861|NCT02455557|Drug|Montanide ISA 51 VG|Given SC
16059862|NCT02455557|Biological|Sargramostim|Given SC
16059863|NCT02455557|Biological|SVN53-67/M57-KLH Peptide Vaccine|Given SC
16059864|NCT02455557|Drug|Temozolomide|Given PO or IV
16059865|NCT02455518|Drug|Oxycodone/acetaminophen|
16059866|NCT02455518|Drug|Hydrocodone/acetaminophen|
16059867|NCT02455518|Drug|Codeine/acetaminophen|
16059868|NCT02455518|Drug|Ibuprofen/acetaminophen|
16059869|NCT02455505|Behavioral|background questionnaire|
16059870|NCT02455505|Behavioral|bereavement risk screening tool|
16059871|NCT02455492|Other|stroke or myocardial infarction or pneumonia|There are three main exposure groups with exposure defined as a binary variable (yes/no): Stroke in the six months prior to surgery; Myocardial infarction in the six months prior to surgery; Pneumonia in the six months prior to surgery
16059872|NCT02455479|Biological|dAd5GNE Vaccine|dAd5GNE Vaccine or Placebo dAd5GNE Vaccine
16059873|NCT02455479|Biological|Placebo|dAd5GNE Vaccine or Placebo dAd5GNE Vaccine
16059874|NCT02455453|Drug|18F-FFNP|
16059875|NCT02455453|Device|CTI/Siemens Biograph 40 PET/CT Scanner|"Will include (1) 18-FDG-PET/CT scan
~Will include (2) 18F-FFNP-PET/CT scans"
16059876|NCT02455453|Drug|Estradiol|
16059877|NCT02455453|Drug|18F-FDG|
16059878|NCT02455440|Drug|Esmolol|effect of esmolol on intraoperative fluctuations of propofol and sevoflurane. Propofol and sevoflurane intraoperative concentration will be expressed as mean ± SD. Differences in categorical data will be evaluated using the student t test.
16059879|NCT02455440|Drug|Placebo|
16059880|NCT02455440|Drug|Propofol and sevoflurane|
16059881|NCT02455427|Device|Active tDCS|Active tDCS will be applied with the anode positioned over the ipsilesional primary motor cortex and the cathode over the contralateral supraorbital region for 20 minutes (1mA).
16059882|NCT02455427|Other|Physical Therapy|Physical therapy will be administered for 60 minutes
16059883|NCT02455427|Device|Sham tDCS|In sham tDCS, no current will be delivered through the tDCS device.
16059884|NCT02455401|Drug|High dose remifentanil|Intervention: continuously intravenous infusion of remifentanil 0.1 mcg/kg/min after bolus injection of remifentanil 1.0 mcg/kg for 2 minutes
16059885|NCT02455401|Drug|Low dose remifentanil|Intervention: continuously intravenous infusion of remifentanil 0.1 mcg/kg/min after bolus injection of remifentanil 0.5 mcg/kg for 2 minutes
16059886|NCT02455401|Drug|No remifentanil|Intervention: no remifentanil will be administrated
16059887|NCT02455388|Dietary Supplement|High added sugar diet|Controlled feeding study. Participants will be provided with daily coolers containing foods with high (25%) added sugar to consume for 7 consecutive days. Fasting fingerstick blood samples and weight checks will be performed each morning.
16059888|NCT02455388|Dietary Supplement|Low added sugar diet|Controlled feeding study. Participants will be provided with daily coolers containing foods with low (5%) added sugar to consume for 7 consecutive days. Fasting fingerstick blood samples and weight checks will be performed each morning.
16059889|NCT02455362|Drug|Morphine sulfate|Treatment with sustained-release morphine sulfate is given as one double-blind capsule in the morning.
16059890|NCT02455362|Drug|Placebo|
16059891|NCT02455336|Drug|Fenofibrate|Fenofibrate is a peroxisome proliferator-activated receptor alpha agonist that is demonstrated to reduce triglyceride concentrations in the blood.
16059892|NCT02455336|Other|No intervention|A cohort of participants will be randomized to receive no study drug, but will engage in study encounters.
16059893|NCT02455323|Other|Suboccipital inhibitory|According to this technique, the suboccipital musculature is palpated until contact is made with the posterior arch of the atlas, and progressive and deep gliding pressure is applied, pushing the atlas anteriorly. The occiput rests on the hands while the atlas is supported by the fingertips. Finger pressure must be maintained for 10 minutes to produce the therapeutic effect of inhibiting the suboccipital soft tissues. The aim is to suppress spasm of the muscles and in general of the suboccipital soft tissues which are responsible for any dysfunctional mobility of the occiput, atlas, or even the axis.
16059894|NCT02455323|Other|Spinal manipulative|This technique is performed along an imaginary vertical line passing through the odontoid process of the axis. No flexion or extension and very little lateroflexion are used. Application is bilateral. First, cephalic decompression is performed lightly, followed by small circumductions. Selective tension is applied to take up tissue slack and create a firm joint barrier. Manipulation is then performed with rotation towards the manipulated side in a helicoidal cranial movement. This technique is designed to correct a generalized dysfunction with the aim of restoring occiput, atlas, and axis joint mobility
16059895|NCT02455323|Other|Combined treatment|Consisted in applying the above two techniques using exactly the same sequence: first the SI technique, and then the SM technique.
16059896|NCT02455323|Other|Control group.|The subjects received no treatment, but attended the same number of sessions, maintaining the resting position for longer than the experimental groups, and underwent the same evaluations (test for arterial compromise, and the three assessments).
16059897|NCT02455310|Behavioral|Educational activities to improve dementia care|The multicomponent intervention included active dissemination of educational resources and optional participation in specialist consultation sessions for up to 6 months. The standard intervention included education through a website or conferences, including clinical tools to support implementation of best practices.
16059898|NCT02455297|Drug|Copanlisib (BAY80-6946)|Starting dose 60 mg (dose reduction due to toxicities to 45 mg allowed). Administered in slow IV bolus on days 1, 8 and 15 of each 28 day cycle until disease progression or until another criterion is met for withdrawal from study treatment.
16059899|NCT02455284|Device|MRI|In vivo MRI with B0 cartography, FLAIR, 3D T1 anatomic images, DWI, and Tractography from DWI images
16059900|NCT02455271|Drug|Eszopiclone|The usual dosage of eszopiclone is 2 mg per dose for adults and 1 mg per dose for elderly participants, taken orally before bedtime. The dosage may be adjusted according to the participant's symptoms, but a single dose should not exceed 3 mg in adults and 2 mg in elderly participants.
16059901|NCT02455258|Other|Dance/Movement Therapy (DMT)|Each DMT session follows a similar structure of Opening, Warm up, Development, Cool Down and Closure. Various themes dedicated to an aging population are addressed by the supervising dance/movement therapist through movement activities and using support material (i.e., props, music). This group is provided in a group setting of maximum 10 participants at a time and occurs 3 times per week for 1 hour each session over the course of 12 weeks.
16059902|NCT02455258|Other|Aerobics Exercise (AE)|The aerobics exercise program is composed of warm up exercises followed by cardiovascular training on a recumbent bicycle. The intensity is set and progressively increased using each participants' individualized maximal aerobic power obtained in the baseline VO2 evaluation. This program respects the recommendations made by the American College of Sports Medicine and their adaptations for aging populations. Each session is supervised by a kinesiologist with 2 participants at a time. The training occurs 3 times per week for 1 hour each session over the course of 12 weeks.
16059903|NCT02455245|Drug|Carboplatin|
16059904|NCT02455245|Drug|Vincristine|
16059905|NCT02455232|Procedure|upper limb muscle block|
16059906|NCT02455232|Drug|4cc of lidocaïne®|
16059907|NCT02455219|Device|Prototype UHRSZ (UltraHigh Resolution Smart Zoom) Collimator|In DATScan SPECT scans, the UHRSZ collimator will be exchanged for the standard collimator following completion of the clinically ordered scan. A scanning sequence will be repeated with the prototype collimator in place. Images from the two scanning sequences will be compared.
16059908|NCT02455206|Behavioral|physical activity counseling|5 face-to-face sessions a 30 minutes during 12 weeks pulmonary rehabilitation program.
16059909|NCT02455206|Behavioral|Usual care|
16059910|NCT02455193|Behavioral|Exercise|
16059911|NCT02455193|Behavioral|Diet|
16059912|NCT02455180|Drug|Ascorbic Acid|Patients receive vitamin C 4 times in either high (5g) or moderate (1g) dose. Vitamin C will be administered intravenously (ascorbinezuur CF 100 mg/ml, Centrafarm BV, Etten Leur, Netherlands) in 50ml of NaCl 0.9%, infused over 30 minutes.
16059913|NCT02455167|Drug|Simeprivir (SMV)|Experimental Single arm study. All participants will get the same treatment.
16059914|NCT02455167|Drug|Sofosbuvir (SOF)|Experimental Single arm study. All participants will get the same treatment.
16059915|NCT02455167|Drug|Ribavirin (RBV)|Experimental Single arm study. All participants will get the same treatment.
16059916|NCT02455154|Drug|Letrozole|Letrozole endocrine therapy for 2.5mg qd po.
16059917|NCT02455154|Drug|Zhongyaofufang|Traditional Chinese Medicine for patients with Osteoporosis
16059918|NCT02455154|Drug|Xianlinggubao|Traditional Chinese Medicine for patients with Osteoporosis
16059919|NCT02455141|Drug|Epirubicin plus Cyclophosphamide|Epirubicin 90mg/m2, d1, q3w*4 Cyclophosphamide: 600mg/m2, d1, q3w*4
16059920|NCT02455141|Drug|Taxanes|Paclitaxel: 80mg/m2, d1, qw*12 or Docetaxel: 80-100mg/m2,d1,q3w*4
16059921|NCT02455141|Drug|Taxanes plus Carboplatin|Paclitaxel: 80mg/m2, d1,d8,d15, q4w*4 Carboplatin AUC=2, d1,d8,d15, q4w*4 or Docetaxel: 75mg/m2,d1,q3w*4 plus Carboplatin AUC=5-6, d1, q3w*4
16059922|NCT02455128|Other|Therapeutic listening|Method of responding to others in order to encourage better communication and clearer understanding of personal concerns.
16059923|NCT02455115|Other|Alternating mean arterial pressure|In normovolemic patients directly after liver transplantation, target mean arterial pressure is altered using norepinephrine according to study protocol.
16059924|NCT02455115|Drug|Norepinephrine|Infusion rate of norepinephrine is raised and lowered, respectively, in order to reach MAP 60, 75 and 90 mmHg in patients already requiring vasopressor for adequate blood pressure control.
16059925|NCT02455115|Drug|Chromium ethylenediaminetetraacetic acid|Extraction of 51Cr-EDTA measured for FF and GFR
16059926|NCT02455102|Other|Electronic warning alert|A newly-installed warning system for stroke prevention in atrial fibrillation.
16059927|NCT02455089|Other|GADD34 RNA level measurement.|"Blood analysis including GADD34 RNA level measurement is performed every 3 months up to 1 year for SLE patients.
~A modal including physical exam, standard biological results and GADD34 RNA level is correlated to a SLE flare occurence in the next 3 months."
16059928|NCT02455076|Drug|Exenatide|Exenatide is dispensed via a 1.2 mL prefilled pen with 250 mcg/mL solution for subcutaneous (s.c.) injection and will be administered twice daily starting at 5 mcg per dose, either in the abdomen, thigh or upper arm. Exenatide injections will be given within 60 minutes prior to morning and evening meals (or before the two main meals of the day, approximately 6 hours or more apart between doses). The exenatide dose will be increased to 10 mcg twice daily after 1 month based on clinical response.
16059929|NCT02455076|Drug|Glargine|"Glargine will be given once daily, at the same time of day. If the BG is between 140-200 mg/dL, the dose will be 0.2 units/kg/day; for BG levels 201-400 mg/dL, the dose will be 0.25 units/kg/day. The patients will be discharged on glargine once daily at 50% of the hospital dose.The total daily dose (TDD) of glargine is based on the patient's fasting BG levels for the last 2 days.
~FBG >180 mg/dL, no hypoglycemia; glargine increased by 4 IU.
~FBG >140 mg/dL, no hypoglycemia; glargine increased by 2 IU.
~FBG 100-140 mg/dL, no hypoglycemia; no change in dosage.
~FBG 70 - 99 mg/dl, decrease glargine by 4 IU or 10% of TDD.
~FBG or RBG < 70 mg/dl, decrease glargine by 8 IU or 20% of TDD.
~FBG or RBG < 40 mg/dl, decrease dose of glargine by 30%."
16059930|NCT02455076|Drug|Rapid-acting insulin analogs|"If the BG levels are >140 mg/dL, rapid acting insulin analogs will be administered following the supplemental/sliding scale protocol. If a patient is able and expected to eat all or most of his/her meals, supplemental insulin will be administered before each meal and at bedtime following the usual dose of the sliding scale protocol. If a patient is not able to eat, supplemental insulin will be administered every 6 hours following the sensitive dose of the sliding scale. If the BG is 141-180 mg/dL, then 2,3 or 4 units of insulin will be given; for BG 181 - 220 mg/dL; the units of insulin will be 3, 4 or 6; for BG 221 - 260 mg/dL, the units of insulin will be 4,5 or 8; for BG 261 - 300 mg/dL, the units of insulin will be 5, 6 or 10; for BG 301 - 350, the insulin will be 6, 8 or 12 units; for BG 351 - 400 mg/dL, the units of insulin will be 7,10 or 14; for BG> 400 mg/dL, the insulin will be 8,12 or 16 units."
16059931|NCT02455050|Drug|Carboxymethylcellulose Sodium Based Eye Drops|1 to 2 drops of Carboxymethylcellulose Sodium Based Eye Drops [New Eye Drop Formula] in each eye.
16059936|NCT02454998|Other|orthodontic treatment|Braces on the upper dental arch previous to surgical alveolar bone grafting. the goal is optimizing the structure of dental-alveolar structure.
16059937|NCT02454972|Drug|lurbinectedin (PM01183)|
16059938|NCT02454959|Device|GFF MDI (PT003) with Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) with Aerochamber Plus Valved Holding Chamber
16059939|NCT02454959|Device|GFF MDI (PT003) without Aerochamber|Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) without Aerochamber Plus Valved Holding Chamber
16059942|NCT02454907|Other|Communication with the clinic|Over the course of the study, subjects will receive brief periodic communications on their cellular phone from the doctor's office.
16059943|NCT02454894|Drug|lidocaine|surface anesthesia with lidocaine
16059944|NCT02454894|Procedure|postoperative management|lying without the pillow for half an hour after lumbar puncture
16059945|NCT02454881|Drug|Dexmedetomidine|
16059946|NCT02454881|Drug|Oxycodone|
16059947|NCT02454868|Drug|Remifentanil|Remifentanil for intubation without neuromuscular blockade
16059948|NCT02454855|Drug|melatonin|"Oral supplementation with melatonin (tablets) will be administered for 3 months once daily , 1-2 hours before bedtime. It will start on the day of the first administration of the new line of anticancer treatment (or no later on the day of the second administration of the new line of anticancer treatment).
~Melatonin supplementation is achieved by the administration of (Circadin) at a dose of 2 mg / day according to its MA form of prolonged-release tablet of 2 mg."
16059949|NCT02454855|Drug|placebo|Oral supplementation with placebo (tablets) will be administered for 3 months once daily , 1-2 hours before bedtime. It will start on the day of the first administration of the new line anticancer treatment (or no later on the day of the second administration of the new line of anticancer treatment).
16059950|NCT02454842|Drug|TH-4000 (Tarloxotinib)|TH-4000 (Tarloxotinib) is a hypoxia-activated prodrug
16059951|NCT02454829|Other|questionnaire|A questionnaire will be send concerning the patient's ovarian function since the cryopreservation procedure i.e: progression of puberty, menstrual cycle, hormonal treatment, desire for pregnancy, occurence of pregnancy, details of pregnancy, need for ART (Artificial Reproductive Techniques), and about the patient's satisfaction concerning the cryopreservation procedure. Data collected will be correlated with treatments received.
16059952|NCT02454816|Device|Single HIV RDT and single syphilis RDT|It is a diagnostic intervention, at the cluster level This arm includes a single (separate) rapid test for HIV and Syphilis. In this case pregnant women enrolled are sampled with two drops of blood (one for each cassette). Positive patients for syphilis are treated immediately and reactive patients for HIV continue with their diagnostic algorithm, in any case patients receive appropriate counseling
16059953|NCT02454816|Device|Dual HIV/syphilis RDT|It is a diagnostic intervention, at the cluster level. This arm includes a dual rapid test for HIV and syphilis, which means that in the same cassette will be available the information about the results for both conditions. In this case pregnant women enrolled are sampled with one drop for the cassette, which is enough to get both of the results. Positive patients for syphilis are treated immediately and reactive patients for HIV continue with their diagnostic algorithm, in any case patients receive appropriate counseling
16059954|NCT02454790|Radiation|Radiotherapy|
16059955|NCT02454777|Behavioral|Exercise Intervention|Undergo HIT
16059956|NCT02454777|Other|Laboratory Biomarker Analysis|Correlative studies
16059957|NCT02454777|Other|Quality-of-Life Assessment|Ancillary studies
16059958|NCT02454777|Other|Questionnaire Administration|Ancillary studies
16059959|NCT02454764|Drug|Tenofovir + Interferon alpha 2b|
16059960|NCT02454764|Drug|Tenofovir disoproxil Fumarate|
16059961|NCT02454751|Drug|fentanyl|One time dose of 50mcg of fentanyl administered intranasally
16059962|NCT02454738|Radiation|Ultralow dose chest CT scan|Ultralow-dose chest CT scan is performed using a 64-row multidetector CT system (Discovery CT750HD; GE Healthcare, Waukesha, WI) with 1.25-mm-thick axial slices at less than 1 mSv (volume computed tomography dose index: 0.39 milligray).
16059963|NCT02454725|Behavioral|Social Network|Leaders of social networks will undergo small group training to develop skills to convey information effectively and deliver messages endorsing regular HIV testing to members of their social networks.
16059964|NCT02454725|Behavioral|Comparison|All participants will receive HIV counseling and rapid testing following the Wisconsin Department of Health guidelines. Sexually active men who receive a negative test result will be told that they should be HIV-tested every three to six months, unless they have a monogamous HIV negative partner
16059965|NCT02454712|Drug|PF614|PF614 is an oxycodone prodrug
16059966|NCT02454712|Drug|Oxycodone extended-release|Oxycodone extended-release is the comparator drug
16059967|NCT02454712|Drug|Naltrexone Hydrochloride|Naltrexone HCl tablets, 50 mg, will be used to block high dose opioid effects in healthy volunteers
16059968|NCT02454699|Drug|MBX400|MBX-400, a white to off-white crystalline powder, will be given orally x 7 days to 4 cohorts. Cohort 1 receives 100 mg/day, Cohort 2 receives 350 mg, Cohort 3 receives 750 mg, Cohort 4 receives 1000 mg.
16059969|NCT02454699|Other|Placebo|Placebo capsules are supplied as white opaque, hard gelatin capsules filled with microcrystalline cellulose. 2 subjects from each cohort receive Placebo orally once per day x 7 days.
16059970|NCT02454660|Behavioral|SMS (Text messages)|Up to 1 text message a day. The artificial agent will determine whether to send a message each day. If it sends a message, it will also determine which of five message types to send.
16059971|NCT02454647|Drug|Induction chemotherapy|
16059972|NCT02454647|Radiation|Radiotherapy with concurrent chemotherapy|
16059973|NCT02454647|Procedure|Salvage surgery|
16059974|NCT02454634|Drug|IDH1 peptide vaccine|
16059975|NCT02454621|Behavioral|Volitional help sheet|Participants are asked to form implementation intentions using a volitional help sheet (Armitage, 2008).
16060025|NCT02454322|Drug|Magnesium Sulfate|Standard of care Magnesium Sulfate given to women with a diagnosis of a hypertensive disorder of pregnancy.
16060026|NCT02454309|Dietary Supplement|Cranberry concentrate|
16060027|NCT02454309|Dietary Supplement|Placebo|
16059976|NCT02454608|Drug|Verapamil HCl|Verapamil represents a calcium channel blocker which binds to the alpha subunit of L-type voltage dependent calcium (Cav1) channels thereby blocking the influx of calcium ions into the host cell. While Verapamil is classically used to promote the relaxation of cardiac and smooth muscle cells, recent evidence has suggested that it may also function as an immunomodulator in astrocytes, hepatocytes, and T-cells. Further research has demonstrated that Verapamil is capable of specifically reducing Th2 associated inflammation in asthma. These findings raise the provocative question as to whether Verapamil could also be effective in reducing inflammation in chronic rhinosinusitis with nasal polyps.
16059977|NCT02454608|Other|Placebo|Capsule with the same characteristics (size, color, smell) as Verapamil HCl.
16059978|NCT02454595|Behavioral|Registry|Physician will complete a series of four questionnaires to capture the treatment decisions based upon standard clinical-pathological information and with the addition of the result of genomic testing (Prolaris test).
16059979|NCT02454582|Device|Somanetics INVOS Cerebral Oxymeter 5100C|Non- invasive transcranial near infrared cerebral oxygenation with or without CPAP
16059980|NCT02454556|Drug|FOLITIME®|
16059981|NCT02454556|Drug|Gonal-F®|
16059982|NCT02454543|Procedure|Radical prostatectomy|Study participants randomized in the intervention arm receive best systemic therapy in addition to radical prostatectomy with extended lymphadenectomy. It is not crucial whether the radical prostatectomy is performed open or robot-assisted.
16059983|NCT02454543|Drug|Best systemic therapy|"For the antiandrogenic therapy a non-steroidal antiandrogen (e.g. flutamide, bicalutamide) or a gonadotropin-releasing hormone (GnRH) analogues (e.g. goserelin, leuprolide) are available.
~The selection of best systemic therapy is up to the judgment of the treating urologist."
16059984|NCT02454530|Biological|Nivestim®|
16059991|NCT02454504|Drug|sugammadex|
16059992|NCT02454504|Drug|Neostigmine|
16059993|NCT02454491|Drug|Heparin|intraradial administration of heparin 5000 ui
16059994|NCT02454491|Drug|Verapamil|intraradial administration of verapamil 5 mg
16059995|NCT02454478|Drug|Lenvatinib|
16059996|NCT02454478|Drug|Everolimus|
16059997|NCT02454465|Other|Acceptance and Commitment Therapy group|Six week, Acceptance and Commitment Therapy group for those with adjustment difficulties following an acquired/traumatic brain injury or other neurological condition.
16059998|NCT02454452|Procedure|Radiofrequency|Radiofrequency treatment applied to the vein with VNUS Closure Fast catheter
16059999|NCT02454452|Procedure|Saphenous vein stripping|Saphenous vein stripping
16060000|NCT02454452|Procedure|CHIVA|conservative hemodynamic treatment venous insufficiency
16060001|NCT02454439|Other|CRT implantation|
16060002|NCT02454426|Drug|Vortioxetine|open label treatment
16060003|NCT02454413|Other|denture brushing with water and soap|denture brushing with water and soap
16060004|NCT02454413|Other|ultrasonic denture cleaning|ultrasonic denture cleaning
16060005|NCT02454413|Other|cleansing tablet|addition of a cleansing tablet to the water in which the dentures are stored overnight
16060006|NCT02454400|Other|Pre-surgery physiotherapy|"Physiotherapy guided intervention twice a week for nine weeks. The program includes:
~Active physiotherapy according to a treatment based classification:
~Specific exercises and mobilization
~Motor control exercises
~Traction
~Tailor-made general supervised exercise program
~Behavioral approach to reduce fear avoidance and increase activity level.
~Standardized information about:
~the surgery
~post-surgery rehabilitation
~to stay active"
16060007|NCT02454400|Other|Waiting-list|"Standardized information about:
~the surgery
~post-surgery rehabilitation
~to stay active"
16060008|NCT02454387|Drug|ONO-4474 Part A1|Healthy volunteers
16060009|NCT02454387|Drug|Placebo Part A1|Healthy volunteers
16060010|NCT02454387|Drug|ONO-4474 Part A2|Healthy volunteers
16060011|NCT02454387|Drug|Placebo Part A2|Healthy volunteers
16060012|NCT02454387|Drug|ONO-4474 Part B|Healthy volunteers
16060013|NCT02454387|Drug|Placebo Part B|Healthy volunteers
16060014|NCT02454387|Drug|ONO-4474 Part C|Healthy volunteers
16060015|NCT02454387|Drug|Placebo Part C|Healthy volunteers
16060016|NCT02454387|Drug|ONO-4474 Part D|Healthy volunteers
16060017|NCT02454387|Drug|Placebo Part D|Healthy volunteers
16060018|NCT02454374|Procedure|Knee Loading protocol|The clinician will review the patient at follow up appointments a further two to four times during the treatment period (dependent on symptom resolution/response), progressing to the next level of exercises or by increasing intensity, duration or repetitions as appropriate (each participant will be asked to maintain a home treatment diary sheet). The physiotherapist will encourage compliance during the treatment period and beyond.
16060019|NCT02454374|Procedure|Routine Physiotherapy Care|Routine Physiotherapy Care
16060020|NCT02454361|Drug|KBP-7072|KBP-7072
16060021|NCT02454361|Drug|Placebo|Placebo
16060022|NCT02454348|Drug|Vasopressin|Subjects will receive vasopressin (0.04 units/min) by continuous infusion to achieve and maintain a target mean arterial pressure (65-75 mm Hg). The treating physician may choose the initial dosage of norepinephrine within the initial range of 0.05-0.5 mcg/kg/min. The treating physician may alter the target mean arterial pressure if clinically indicated.
16060023|NCT02454348|Drug|Norepinephrine|Subjects will receive norepinephrine (0.05 to 0.5 mcg/kg/min) by continuous infusion with titration by bedside nurse to achieve and maintain a target mean arterial pressure (65-75 mm Hg). The treating physician may choose the initial dosage of norepinephrine within the initial range of 0.05-0.5 mcg/kg/min. The treating physician may alter the target mean arterial pressure if clinically indicated.
16060024|NCT02454335|Procedure|Peroral Endoscopic Myotomy|The intervention is the POEM procedure performed by either anterior approach or posterior approach orientation of the incision for mucosal entry.
16060153|NCT02453516|Drug|epinephrine|Drug indicated to prolong the action of regional anesthesia
16060028|NCT02454296|Drug|Paracervical Block with lidocaine|Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion
16060029|NCT02454296|Drug|Sham paracervical block|A capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes
16060030|NCT02454283|Drug|Vanoxerine HCl|
16060031|NCT02454283|Drug|Placebo|
16060032|NCT02454270|Drug|Part 1 (Dose Escalation): Duvortuxizumab|Participants currently enrolled in the study will continue to receive duvortuxizumab every 14 days (biweekly dosing) in each 28 -day cycle as an intravenous infusion. In the priming dose regimen, a priming dose will be administered on Day 1 followed by full doses on Day 8 and Day 22, of a 35-day Cycle 1, and then every 14 days in each subsequent 28-day cycle. The cohorts will be opened where participants will receive duvortuxizumab every 7 days (for investigating weekly dosing schedule) in each 28-day cycle as an intravenous infusion. In the priming dose regimen, a priming dose will be administered on Day 1 followed by full doses on Day 8, Day 15, Day 22, and Day 28 of a 35-day Cycle 1, and then every 7 days in each subsequent 28-day cycle.
16060033|NCT02454270|Drug|Part 2 (Dose Expansion): Duvortuxizumab|Participants will receive intravenous infusion of duvortuxizumab at the recommended Phase 2 dose (RP2D) defined in Part 1 for their disease type either with or without a priming dose.
16060034|NCT02454244|Behavioral|ART with Mindfulness|"Introduction of ART with Mindfulness. Visualization of 100% recovery
~Developing Fibromyalgia and CFS. How stress triggers the central nervous system. The benefits of Mindfulness in chronic stress. Mindfulness Practice. Breathing meditation
~The ART. Breaking the negative thoughts related to the illness. Walking meditation
~Mindfulness and the Body Scan. Breaking the cycle of stress. Body-scan meditation
~Mindfulness and self-compassion. Kindly awareness meditation
~The accelerator of ART. Behaviors related to CFS and Fibromyalgia. Metta meditation
~Aware of negative thoughts related to stress stimulus. Mindfulness in daily activities
~Limiting beliefs, identity patterns. Motivation and sense of life. Meditation on values
~The recovery, cycles and stages. Fear of fail about recovery. Positive Visualization of future self
~Return to regular life. Mindfulness practice"
16060035|NCT02454244|Behavioral|Mindfulness Compassion|"Introduction.Definition of Compassion
~Self-Esteemed and Compassion
~Cultivate the understanding of the nature of inner experience. Working positive and negative thoughts.Connecting with difficult emotions
~Identifying the causes of suffering.How participants contribute to their own suffering. Attachments.Practice of Vulnerability
~Love,affection and self-compassion.How participants connect with the suffering of others
~Equanimity
~Forgiveness
~Interdependence. Gratitude.Affection to unknown people
~Developing affection and empathy.Empathy and burn out
~Review of the practices and meditations"
16060036|NCT02454244|Behavioral|Relaxation|10 sessions based on relaxation techniques as active comparator intervention
16060037|NCT02454231|Biological|Transplantation of circulating CD14+CD34+cells|intramuscular injection of circulating EPC at leg level
16060038|NCT02454231|Biological|Transplantation of BM MNC|intramuscular injection of BM MNC at leg level
16060039|NCT02454218|Device|Transcranial Direct Current Stimulation|"The intervention session with tDCS lasts for 20 minutes. tDCS uses rubber electrodes that are within sponges that are moistened with saline. These electrodes are placed on the participant's head. Through these electrodes will pass a weak electrical current that can at most cause mild itching at the site where the electrode is positioned. The generated electric current is equivalent to a small common battery that we use to run toys or radios. The procedure does not require that the patient be subjected to shocks, cuts or surgery.
~The participant will receive active tDCS or placebo, but receive both types of intervention during the performance of the two sessions."
16060040|NCT02454205|Drug|Linezolid|600mg Linezolid po daily, reduced to 300mg po daily if toxicity occurs.
16060041|NCT02454205|Drug|Bedaquiline|400mg po daily for 2 weeks, followed by 200mg three times per week .
16060042|NCT02454205|Drug|Levofloxacin|750mg (<50kg) 1000mg (>50kg)
16060043|NCT02454205|Drug|Pyrazinamide|1000-1750mg (40-50kg) 1750-2000mg (51-70kg) 2000-2500mg (71-90kg)
16060044|NCT02454205|Drug|Isoniazid|high dose Isoniazid 500mg (40-50kg) 750mg (51-70kg) 750-1000mg (71-90kg)
16060045|NCT02454205|Drug|Ethionamide|15mg/kg (max 900mg)
16060046|NCT02454205|Drug|Terizidone|750mg (40-70kg) 750-1000mg (71-90kg)
16060047|NCT02454205|Drug|Moxifloxacin|400mg po daily.
16060048|NCT02454205|Drug|Kanamycin|500-750mg (40-50kg) 1000mg (51-90kg) intramuscular daily during 6-8 month intensive phase.
16060049|NCT02454192|Behavioral|CHAMPS|
16060050|NCT02454179|Drug|pembrolizumab|
16060051|NCT02454179|Drug|Acalabrutinib|
16060052|NCT02454166|Other|Ischemic stroke TCM syndromes Diagnostic Scale|A scale for Chinese medical differentiation
16060053|NCT02454166|Other|Meridian Energy Analysis Device|A Device to assess involving meridian in certain diseases
16060054|NCT02454153|Device|REMStar Positive Airway Pressure|Positive airway pressure therapy is the standard of care for managing obstructive sleep apnea
16060055|NCT02454153|Behavioral|LifeStyle Counseling|Lifestyle guidelines developed by the American Diabetes Association for weight loss will be provided to all subjects.
16060056|NCT02454140|Radiation|SBRT|Fixed five-fraction stereotactic radiotherapy
16060057|NCT02454127|Behavioral|Atkins Diet|Dietary counseling for 1 year
16060058|NCT02454127|Behavioral|Zone Diet|Dietary counseling for 1 year
16060059|NCT02454127|Behavioral|Weight Watchers Diet|Dietary counseling for 1 year
16060060|NCT02454127|Behavioral|Ornish Diet|Dietary counseling for 1 year
16060061|NCT02454114|Other|HOMEFIRST|HOMEFIRST patients receive monitoring and review of; vital signs, symptoms, mental state, nutrition and hydration, urine output, skin turgor and integrity, mobility, coping ability, medication concordance, smoking and nutrition and hydration. Individualised verbal and written self-management plans, a list of symptoms (including red flag symptoms) to prompt contact with the study team and a 24hr emergency contact number are provided. Clinical bloods and other investigations will be taken/requested as necessary. Questionnaires will be completed as follows; SF-12 - at recruitment and 6 weeks, CAP-SYM - at recruitment and 6 weeks. Satisfaction questionnaires are conducted over the telephone at 2 wks by an independent assessor. As part of usual clinical practice patients will have bloods and radiology requested as required.
16060150|NCT02453516|Procedure|Serratus Block|Ultrasound-guided nerve block using ropivacaine 0.5% (0.4ml/kg) injected between the serratus anterior and external intercostal muscles
16060062|NCT02454114|Other|Standard Hospital Care|"No research investigations will occur except for questionnaires; as part of usual clinical practice patients will have bloods and radiology requested as desired by their usual clinical team.
~SF-12 (physical and mental function) [performed twice in total] - at recruitment (day 0) and 6 weeks
~CAP-SYM [performed 3 times in total] - at recruitment day 0 (twice including day minus 30) and 6 weeks
~Patient (and carer/consultee) satisfaction - conducted over the telephone at 2 wks by an independent assessor."
16060063|NCT02454101|Procedure|cord milking|milking of the cord 5 times toward the neonate
16060064|NCT02454101|Procedure|delayed cord clamping|delay clamping of the cord for 120 seconds
16060065|NCT02454088|Other|Calcium Hydroxylapatite and Triamcinolone acetate|Combination Therapy Triamcinolone acetate and Calcium Hydroxylapatite
16060066|NCT02454088|Device|Calcium Hydroxylapatite and Placebo|Calcium Hydroxylapatite and Placebo
16060067|NCT02454075|Drug|YF476|Gastrin receptor antagonist
16060068|NCT02454062|Drug|TAS-114|TAS-114 is an inhibitor of dUTPase, a gatekeeper protein in pyrimidine-metabolism.
16060069|NCT02454062|Drug|S-1|S-1 is an oral antimetabolite; a combination of three pharmacological compounds: tegafur (FT), gimeracil (CDHP), and oteracil (Oxo)
16060070|NCT02454049|Dietary Supplement|beetroot juice|6mmol nitrate
16060071|NCT02454049|Dietary Supplement|sodium nitrate|6mmol sodium nitrate
16060072|NCT02454049|Dietary Supplement|water|plain water
16060073|NCT02454036|Behavioral|BBI intervention|Psychological intervention designed to reduce stress and enhance quality of life
16060074|NCT02454023|Device|Portable sleep monitor (ApneaLink Air)|Use of a portable sleep monitor that records respiratory effort, pulse, oxygen saturation and nasal flow, and reports apneas, hypopneas, flow limitation, snoring and blood oxygen saturation in order to detect obstructive sleep apnea.
16060075|NCT02454023|Device|In-laboratory polysomnography|Level 1 in-laboratory polysomnography for the detection of obstructive sleep apnea.
16060076|NCT02454010|Biological|FF21101|(90Y) radio-labeled FF21101 (therapeutic monoclonal antibody to P-cadherin expressed by the CDH3 gene)
16060077|NCT02453984|Other|89Zr-MPDL-3280A-PET scans|89Zr-MPDL3280A tracer injection and 89Zr-MPDL-3280A-PET scans
16060078|NCT02453971|Other|German Version of eCHECKUP TO GO|It is an online prevention program targeting alcohol consumption.
16060079|NCT02453958|Device|Multi-modal assessment system|Subjects were assessed using a multi-modal concussion assessment battery incorporating eye-tracking, balance, and neurocognitive tests
16060080|NCT02453945|Device|Adjustable Support Bra|A ClearPoint Medical support bra
16060081|NCT02453932|Drug|Tianzhi granule and placebo identified to donepezil|1 pack Tianzhi granule (5g), 3 times per day and placebo identified to donepezil, 1 pill per day for 24 weeks
16060082|NCT02453932|Drug|Donepezil and placebo identified to Tianzhi granule|donepezil 5mg per day and placebo identified to Tianzhi granule (5g, 3 times per day) for 24 weeks
16060083|NCT02453932|Drug|Placebo|placebo identified to Tianzhi granule (5g, 3 times per day) and placebo identified to donepezil ,1 pills per day for 24 weeks
16060084|NCT02453906|Other|XNKQ|stimulation at 5 acupuncture points according to XNKQ acupuncture
16060085|NCT02453906|Other|Control 1|no stimulation at 5 acupuncture points according to XNKQ acupuncture
16060086|NCT02453906|Other|Control 2|stimulation at 5 control points
16060087|NCT02453906|Other|Control 3|no stimulation at 5 control points
16060088|NCT02453893|Drug|Iloperidone|
16060089|NCT02453893|Drug|Risperidone|
16060090|NCT02453880|Behavioral|Web-based Cognitive Behavioral Therapy|"Participants will be asked to complete a web-based cognitive behavioral therapy self-help program. The program consists of six weekly modules, in which participants practice new ways of thinking (e.g. how to recognize and change distorted thinking, utilizing a thought change record, identifying cognitive errors, and modifying automatic thoughts) to reduce symptoms of anxiety and depression. Participants receive text message reminders to complete the weekly session."
16060091|NCT02453867|Other|Reduced immunosuppression|Stop steroids at month 3 Stop mycophenolate at month 6 continue tacrolimus once daily (Advagraf, trough levels > 5ng/ml) Stop mycophenolate at month 6
16060092|NCT02453867|Drug|Tacrolimus|Tacrolimus is used in both the acitve comparator arm and the interventional arm
16060093|NCT02453867|Drug|mycophenolate|Mycophenolate is used in the acitve comparator arm for the whole study period; Mycophenolate is stopped at month 6 after Transplantation (month 3 of the study) in the experimental arm
16060094|NCT02453867|Drug|Steroids|Steroids are used continually in the active comparator arm and are stopped at the beginning of the study (month 3 after Transplantation) as an Intervention in the experimental arm
16060095|NCT02453854|Behavioral|Group motivational interviewing|Monthly group meetings were held for two hour sessions each month and verifiable (treatment fidelity checked) motivational interviewing employed in helping clients make health behaviour changes.
16060096|NCT02453841|Drug|Oxymetazoline|
16060097|NCT02453828|Procedure|Non-cardiac surgery|patients having non-cardiac surgery
16060098|NCT02453815|Procedure|non-cardiac surgery|all surgical procedures except cardiac
16060099|NCT02453815|Other|arterial catheter|arterial catheter
16060100|NCT02453802|Drug|Tranexamic Acid 5%,5ml/amp|Intraarticular application of tranexamic acid 3g (60ml) in 100 ml normal saline into knee joint after closure of the joint capsule
16060101|NCT02453802|Drug|Tranexamic Acid 5%,5ml/amp|IV TXA group: Primary total knee replacement with 1 g tranexamic acid administrated intravenously before deflection of the tourniquet
16060102|NCT02453802|Drug|rivaroxaban (10mg)|Oral rivaroxabam (10mg) QD on PostOp Day 1 to 14.
16060103|NCT02453802|Drug|0.9% Normal Saline|Primary total knee replacement with intravenous normal saline (20 ml) administration before deflation of the tourniquet
16060104|NCT02453802|Drug|0.9% Normal Saline|Topical 160 ml normal saline application after closure of joint capsule.
16060105|NCT02453789|Drug|Alginate oligosaccharide|Inhalation of dry powder for inhalation (DPI)
16060106|NCT02453789|Drug|Placebo|
16060107|NCT02453776|Drug|PRECISION dosing Infliximab|Patients in the PRECISION dosing arm will recieve model based dosing, whereas proactive adjustments in treatment can be made by measuring the Infliximab concentration.
16060151|NCT02453516|Procedure|Placebo Block|Subcutaneous injection of 1ml sterile normal saline solution in the midaxillary line
16060108|NCT02453763|Device|Transcranial direct current stimulation|All participants will receive transcranial direct current stimulation. During the MRI images of the head a battery-powered device pulses a small current between a pair of the electrodes which will be immediately followed by more MRI images. The current pulses will be very short and there should be no feeling from the pulses. The entire imaging period will be at most 90 minutes.
16060109|NCT02453763|Procedure|MRI|All participants will receive an MRI. During the MRI images of the head a battery-powered device pulses a small current between a pair of the electrodes which will be immediately followed by more MRI images. The current pulses will be very short and there should be no feeling from the pulses. The entire imaging period will be at most 90 minutes.
16060110|NCT02453750|Drug|Hypersaline|Subject will inhale 5 mls of 3% hypertonic saline for 7 minutes by nebulizer. Sputum production (with cough) will be attempted post inhalation. A maximum of 3 hypertonic saline inhalations will be attempted if inhalation does not generate a productive cough. If sputum induction is not successful and the FEV1 falls <10%, the concentration of inhaled hypertonic saline will increase from 3 to 4%. If 5 mls of 4% hypertonic saline inhaled for 7 minutes does not produce a productive cough we will proceed to 5%. If 5 mls of 5% hypertonic saline inhaled for 7 minutes does not produce a productive cough the test is complete and the sample is labelled 'no sputum collected'. If FEV1 falls >10%, the previous step will be repeated.
16060111|NCT02453750|Drug|Bronchodilator Response|A bronchodilator (Salbutamol 200 mcg or 2 puffs inhaled via spacer device) will be administered to all subjects in the pulmonary function laboratory. 15 minutes after administration of the bronchodilator spirometry will be repeated. This is performed routinely in CDH clinic and is not an additional test for this study.
16060112|NCT02453737|Radiation|Brachytherapy APBI|
16060113|NCT02453737|Radiation|3D-CRT (photon) APBI|
16060114|NCT02453737|Radiation|Proton APBI|
16060115|NCT02453724|Device|Observation for safety|The investigators will perform the routine lung exam used in emergency department evaluations for shortness of breath in patients scheduled for computed tomography. The investigators will observe if there are any parenchymal changes noted on the chest tomography scan.
16060116|NCT02453711|Drug|semaglutide|Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.
16060117|NCT02453711|Drug|liraglutide|Once-daily subcutaneous (s.c., under the skin) administration with dose escalation.
16060118|NCT02453711|Drug|placebo|Once-daily subcutaneous (s.c., under the skin) administration.
16060119|NCT02453698|Drug|Methylphenidate|oral dose of methylphenidate. The MPH dose was selected based on previous studies in healthy adults (Mehta et al., 2000; Volkow, Fowler, Wang, Ding, & Gatley, 2002) and adults with ADHD (Aron et al., 2003). MPH reaches its peak plasma concentration 1-3 hours after an oral dose, and has a plasma half-life of 1.5-2.5 hours.
16060120|NCT02453698|Other|Placebo|Lactose Placebo
16060121|NCT02453685|Drug|biphasic insulin aspart 30|Injected s.c./subcutaneously once daily with the largest meal Subjects should continue their pre-trial metformin and sulfonylurea dosages all throughout the trial while other oral antidiabetic drugs will be discontinued.
16060122|NCT02453685|Drug|insulin glargine|Injected s.c./subcutaneously once daily at the same time every day, with the possibility of treatment intensification with insulin aspart (Basal-bolus arm) Subjects should continue their pre-trial metformin and sulfonylurea dosages all throughout the trial while other oral antidiabetic drugs will be discontinued.
16060123|NCT02453685|Drug|insulin aspart|Injected s.c./subcutaneously once daily.
16060124|NCT02453672|Biological|SB8|SB8, proposed bevacizumab biosimilar
16060125|NCT02453672|Biological|EU sourced Avastin®|EU sourced Avastin® (bevacizumab, Roche Registration Ltd.)
16060126|NCT02453672|Biological|US Sourced Avastin®|US Sourced Avastin® (bevacizumab, Roche Registration Ltd.)
16060127|NCT02453659|Behavioral|Distress Tolerance Treatment for Weight Concern (DT-W)|
16060128|NCT02453659|Behavioral|Health Education (HE)|
16060129|NCT02453659|Behavioral|Smoking Cessation counseling|
16060130|NCT02453659|Drug|Transdermal Nicotine Patch|
16060131|NCT02453646|Device|NexSite HD Patients|Measurement of CRBSI rate and other device related adverse events in patients with NexSite HD Catheter.
16060132|NCT02453633|Other|Emotional SMS text|"SMS appointment reminder with the following text (translated from Norwegian):
~Reminder about your appointment. There are many who are waiting for treatment. Please notify us if you can not make your appointment on: Tuesday 31 March at 10:00.
~tel. 23225501 or send email to kirpolonh@lds.no later than one weekday prior to your appointment.
~No-show fee: Kr. 640.
~Lovisenberg Diakonale Hospital, Department of Surgery, Ear, Nose and Throat. Do not reply to this message per SMS."
16060133|NCT02453633|Other|Standard SMS text|"SMS appointment reminder with the following text (translated from Norwegian):
~Reminder of appointment at Lovisenberg Diakonale Hospital, Department of Surgery, Ear, Nose and Throat: Wednesday 11.feb 2015 at 10:00. For a change, call tel. 23225501 or send email to kirpolonh@lds.no. Do not reply to this message per SMS."
16060139|NCT02453607|Drug|Infliximab|Drug is prescribed by treating physician and is not a part of the study. This study is non-interventional. Patients, to be elgibile, are being prescribed either monotherapy inlfiximab or combo therapy infliximab with azathiopurine.
16060140|NCT02453607|Drug|thiopurine|Drug is prescribed by treating physician and is not a part of the study. This study is non-interventional. Patients, to be elgibile, are being prescribed either monotherapy inlfiximab or combo therapy infliximab with azathiopurine.
16060141|NCT02453594|Biological|pembrolizumab|IV infusion
16060142|NCT02453581|Drug|OZ439|OZ439 Powder for Oral Suspension
16060143|NCT02453555|Drug|Linagliptin|
16060144|NCT02453555|Drug|Empagliflozin placebo + linagliptin placebo low dose|Matching placebo empagliflozin + linagliptin
16060145|NCT02453555|Drug|Empagliflozin + linagliptin low dose|tablet
16060146|NCT02453555|Drug|Linagliptin placebo|Matching placebo linagliptin
16060147|NCT02453555|Drug|Empagliflozin + linagliptin high dose|tablet
16060148|NCT02453555|Drug|Empa + lina highdose placebo|
16060149|NCT02453529|Drug|WCK 4873|Oral tablets
16060154|NCT02453516|Other|sterile saline|Neutral injection (no drug involved)
16060155|NCT02453503|Drug|Licorice|licorice mucoadhesive films evey 6 hours for two weeks
16060156|NCT02453503|Drug|Triamcinolone Acetonide|Triamcinolone acetonide mucoadhesive films 1 mg every 6 hours for two weeks.
16060157|NCT02453490|Drug|Raltitrexed-based chemotherapy|Raltitrexed: 2.0mg,iv,15min,d1,Oxaliplatin:85mg/m2 iv,d1, q2w
16060158|NCT02453490|Drug|Raltitrexed-based chemotherapy|Raltitrexed: 2.0mg,iv,15min,d1,Irinotecan:180mg/m2 iv,d1, q2w
16060159|NCT02453490|Drug|5-fluorouracil-based chemotherapy|5-fluorouracil:400mg/m2,ivp,2h,d1,1200mg/m2/d*2d(2400mg/m2,iv46-48h); Oxaliplatin:85mg/m2 iv,d1,q2w
16060160|NCT02453490|Drug|5-fluorouracil-based chemotherapy|5-fluorouracil: 400mg/m2,ivp,2h,d1,1200mg/m2/d*2d(2400mg/m2,iv46-48h); Irinotecan:180mg/m2 d1, iv,q2w
16060161|NCT02453477|Genetic|Autologous hematopoietic stem cells genetically modified with GLOBE lentiviral vector encoding for the human beta-globin gene|Autologous CD34+ cell enriched fraction containing hematopoietic stem cells (HSC) transduced with the GLOBE lentiviral vector encoding for the human beta-globin gene resuspended in their final formulation medium. The target dose in the transduced product is 5x10^6 cells/Kg CD34+ cells, with a minimum dose of 2 x 10^6/Kg and a maximum dose of 20 x 10^6/Kg, depending on the yield of cells. The product will be injected intraosseously.
16060162|NCT02453464|Drug|Sevacizumab|escalating doses of Sevacizumab : 3mg/kg，4mg/kg，5mg/kg
16060163|NCT02453464|Drug|Irinotecan|Irinotecan: IV solution, IV over 90 minutes, 180 mg/m², Every 14 days, Until disease progression/toxicity
16060164|NCT02453464|Drug|5-FU|5-FU: IV solution, IV bolus over 2-4 minutes, 400 mg/m²; IV infusion over 46 hours, 2400 mg/m²; Every 14 days, Until disease progression/toxicity
16060165|NCT02453464|Drug|Leucovorin|Leucovorin: IV solution, IV over 2 hours, 400 mg/m², Every 14 days, Until disease progression/toxicity
16060166|NCT02453451|Other|2D-/3D-TTE|recording of 3 cardiac cycles
16060167|NCT02453451|Other|3D-TEE|with colour-Doppler techniques for recording the ASD and the mitral valve
16060168|NCT02453451|Other|Walking Test|for 6 minutes
16060169|NCT02453451|Procedure|MitraClip procedure|catheter-based non-surgical procedure in which the atrioventricular valves were stuck together permanently via a clip (during the regular patient care)
16060170|NCT02453438|Other|Patient Reported Outcomes|Patient reported outcomes will be collected using a variety of questionnaires that assess mood symptoms.
16060171|NCT02453425|Other|MAP 60 mmHg|Norepinephrine adjusted to reach MAP 60 mmHg
16060172|NCT02453425|Other|MAP 75 mmHg|Norepinephrine adjusted to reach MAP 75 mmHg
16060173|NCT02453425|Other|MAP 90 mmHg|Norepinephrine adjusted to reach MAP 90 mmHg
16060174|NCT02453412|Device|AVF-simulation|A mathematical computational tool, which is developed to calculate estimates for postoperative AVF hemodynamical changes in the upper extremity. The model is based on physical laws and calculations are carried out on patient-specific duplex measurements.
16060175|NCT02453399|Device|Randomized treatment/placebo delivery of transcutaneous electro stimulation via a dedicated device Avital.|Transcutaneous electro stimulation
16060176|NCT02453386|Drug|tozadenant|
16060177|NCT02453386|Drug|placebo|
16060178|NCT02453373|Device|ThermoSuit Cooling Induction|Rapid induction of therapeutic hypothermia (32-34 degrees C) using the Life Recovery Systems ThermoSuit System
16060179|NCT02453373|Drug|Magnesium Sulfate|Magnesium sulfate will be administered intravenously as needed to control shivering
16060180|NCT02453373|Drug|tPA|tPA will be administered intravenously if indicated
16060181|NCT02453373|Drug|Propofol|Induction doses of propofol or etomidate will be used to aid in the suppression of patient discomfort
16060182|NCT02453373|Drug|Etomidate|Induction doses of propofol or etomidate will be used to aid in the suppression of patient discomfort
16060183|NCT02453373|Procedure|Neurothrombectomy|If indicated, neurothrombectomy will be performed using an FDA-cleared device within the FDA-cleared treatment window.
16060184|NCT02453360|Procedure|Adductor Canal Block|Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB.
16060185|NCT02453360|Drug|Adductor Canal Block|Following negative aspiration, SSACNB volume will be randomized and subjects will receive 5, 10 or 20 ml of 0.5% bupivacaine will be incrementally injected. Randomization of the volume of bupivacaine will be determined by opening a sequential, pre-sealed envelope with the group assignment designated within. All studied volumes are well within the acceptable range for SSACNB.
16060186|NCT02453347|Device|CES Therapy|Cranial Electrotherapy Stimulation (CES) may serve as an effective complimentary, noninvasive/non-pharmacological treatment for this Veteran population. CES is administered through a therapeutic device (such as Alpha-Stim®) marketed and approved by the FDA to treat insomnia, depression, anxiety, and pain.
16060187|NCT02453334|Drug|Injectafer|
16060188|NCT02453334|Other|Normal Saline|
16060189|NCT02453321|Procedure|Continuous Femoral Nerve Block|A 27g plastic catheter placed below the inguinal crease to perform a conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty
16060190|NCT02453321|Procedure|Nerve Block, Continuous Adductor Canal|A 27g plastic catheter placed on the anterior medial thigh midway between the groin and knee to provide a local anesthetic conduction blockade of the sensory components of the femoral nerve in order to decrease pain in the knee after total knee arthroplasty
16060191|NCT02453321|Procedure|Continuous Sciatic Nerve Block|A transgluteal approach to the sciatic nerve is use to place a 27g catheter. It will only be dose postoperatively after verifying sciatic nerve function still intact. The infusion will be 0.003% bupivacaine at 2ml/hr. This is not the intervention of interest, but our institution's predominant practice is to include the sciatic nerve block as part of the analgesic regimen for total knee arthroplasty.
16060192|NCT02453321|Drug|Bupivacaine|The concentration of the continuous infusion of bupivacaine though the peripheral nerve catheters will be 0.0625% for the femoral and adductor canal blocks and the concentration for the sciatic continuous catheter will be 0.03%.
16060193|NCT02453308|Drug|ACT|"Artemether-lumefantrine for 3 days
~Dihydroartemisinin-piperaquine for 3 days.
~Artesunate-mefloquine for 3 days"
16060194|NCT02453308|Drug|TACT|"Artemether-lumefantrine for 3 days plus Amodiaquine for 3 days.
~Dihydroartemisinin-piperaquine for 3 days plus Mefloquine hydrochloride for 3 days.
~Dihydroartemisinin-piperaquine for 3 days plus Mefloquine hydrochloride for 3 days."
16060195|NCT02453295|Behavioral|Intervention Group|The IG will meet weekly for 2 hours for 8 weeks. Administration of questionnaires (Meaning of Illness, MIQ; Herth Hope Index, HHI; Short Form 12, SF-12; Lymphedema Quality of Life, LYMQOL) will be completed by phone at all timepoints. The questionnaires will also be administered at 4 weeks post-intervention (T3) and 8 weeks (T4) post-intervention. All participants will also complete a demographic questionnaire at T0, developed in S2 as well as a Workshop Evaluation 2 days following the final workshop (T2).
16060204|NCT02453269|Behavioral|Transdisciplinary program|
16060205|NCT02453256|Drug|Placebo|Participants will receive matching placebo subcutaneous (SC) injections once weekly for 48 weeks of double-blind treatment.
16060206|NCT02453256|Drug|Tocilizumab|Participants will receive 162 mg SC tocilizumab once weekly for 48 weeks of double-blind treatment. The same regimen will be given to all eligible participants for 48 weeks of open-label treatment.
16060207|NCT02453243|Behavioral|Safety Planning|Suicide screen-positive patients who are to be discharged from the ED will receive personalized safety planning by a mental health clinician or nurse
16060208|NCT02453243|Behavioral|A Lean Implementation Strategy|"The Safety Planning Intervention will be implemented using Lean performance improvement strategies.
~Sites will be trained on the Safety Planning Intervention and Lean."
16060209|NCT02453230|Behavioral|Lights on|Determine if ambient room light stimulation changes the amount of time required to perform the fetal biophysical profile.
16060210|NCT02453217|Behavioral|Chinese CHIP|The CHIP physical health screening tool will be used by community psychiatric nurses in the treatment group to assess patients' physical health risk and identify problematic lifestyle behaviours. The findings from the assessment will be used to devise an individualized care plan with patients. This treatment plan may involve community psychiatric nurses collaborated with psychiatrists, drawing patients attention to indicators of physical health risk by using a traffic light system The community nurses will use motivational interviewing approaches to make patients be aware of their physical health risks and enhance their motivation to adopt healthier behaviours.
16060211|NCT02453217|Other|Treatment as usual|The routine community mental health care provided by the community psychiatric nursing service and outpatient clinic.
16060212|NCT02453204|Behavioral|Sitting|
16060213|NCT02453204|Behavioral|Standing|
16060214|NCT02453204|Behavioral|Walking|
16060215|NCT02453191|Drug|Talimogene Laherparepvec|Talimogene Laherparepvec
16060216|NCT02453191|Radiation|Radiotherapy|Concurrent Preoperative Radiation. External Beam Radiation Therapy (EBRT) will be given at the standard dose for resectable soft tissue sarcomas. according to the NCCN sarcoma guidelines.
16060217|NCT02453178|Behavioral|Cycling|The experimental group will complete a 3 month exercise program that includes working up to cycling at a moderate intensity for 50 minutes/session 3 times a week. The comparison group will complete a 3-month exercise program that includes intermittent cycling (alternating between passive and moderate intensity) for 50 minutes/session 3 times a week. Both groups will exercise in our laboratory at Spence Labs, and will be supervised by an exercise trainer that is trained in working with elderly and special populations.
16060218|NCT02453165|Procedure|TRANSVAGINAL SUTURE|The closure of the vaginal cuff will be performed transvaginally using a 0-poly-g-lactin braided and coated medium-term reabsorbable suture with vaginal valves and needleholders
16060219|NCT02453165|Procedure|LAPAROSCOPIC SUTURE|The closure of the vaginal cuff will be performed laparoscopically using a 0-poly-g-lactin braided and coated medium-term reabsorbable suture with laparoscopic needleholders
16060220|NCT02453152|Other|History and physical|Subjects will undergo a physical exam and medical history review, including review of genetic test results.
16060221|NCT02453152|Other|Tidal breathing|Subjects' breathing patterns will be evaluated at rest and at reduced/eliminated ventilator support.
16060222|NCT02453152|Other|Maximal respiratory pressures|Subjects' strongest inspiratory and expiratory pressures will be measured.
16060223|NCT02453152|Other|Peak cough flow|Subjects' strongest coughs will be measured.
16060224|NCT02453152|Other|Pediatric Evaluation of Disability Inventory|Assesses the functional capabilities of children with disabilities.
16060225|NCT02453152|Other|PedsQL Multidimensional Fatigue Scale|Assesses general fatigue, sleep/rest fatigue, and cognitive fatigue.
16060226|NCT02453152|Other|Review of ventilation requirements|Subjects's use of mechanical ventilation reviewed by the study team.
16060227|NCT02453139|Behavioral|Exercise|6 month supervised and home based aerobic exercise intervention
16060228|NCT02453113|Other|low power laser|Signaling in Human Skin Associated with Low-Power, Infrared Laser Treatment
16060229|NCT02453100|Behavioral|Mobility and pelvic floor exercise|Mobility and pelvic floor exercises
16060230|NCT02453100|Behavioral|Education|Education on simple ways to manage incontinence
16060231|NCT02453087|Drug|DCDS0780A|Participants will receive escalating doses of DCDS0780A as intravenous infusion.
16060232|NCT02453087|Drug|Rituximab|Participants will receive rituximab at a dose of 375 mg/m^2 of body surface area as intravenous infusion.
16060233|NCT02453087|Drug|Obinutuzumab|Participants will receive obinutuzumab at a dose of 1000 milligrams (mg) as intravenous infusion.
16060234|NCT02453074|Other|Online survey - Follow up for Better Care|
16060235|NCT02453061|Drug|Triheptanoin oil|Triheptanoin oil orally administered at 1g/kg/day
16060236|NCT02453061|Drug|Placebo|Safflower oil orally administered at 1g/kg/day
16060237|NCT02453048|Biological|BPZE1|Intranasal live, attenuated vaccine
16060238|NCT02453048|Other|Placebo|Diluent
16060377|NCT02452060|Other|Placebo Comparator|0.4mg/kg infusion
16060239|NCT02453035|Device|PTCA - Desolve Scaffold|Percutaneous Coronary Artery Intervention with a DESolve bioresorbable coronary scaffold
16060240|NCT02453022|Drug|Danirixin HBr 50 mg IR Tablet|Danirixin HBr 50 mg IR Tablet is white, film-coated, oval-shaped tablet for oral administration.
16060241|NCT02453022|Drug|Danirixin FB 50 mg IR Tablet|Danirixin FB 50 mg IR Tablet is white, film-coated, capsule-shaped tablet for oral administration.
16060242|NCT02453022|Drug|Prilosec (omeprazole) 40mg Delayed-Release capsule|Prilosec (omeprazole) 40 mg delayed-release capsule is opaque, hard gelatin, apricot, and amethyst colored capsules, coded 743 on cap and PRILOSEC 40 on the body for oral administration.
16060243|NCT02453009|Drug|Docetaxel|Pharmaceutical form:solution Route of administration: intravenous
16060244|NCT02453009|Drug|Prednisone|Pharmaceutical form:tablet Route of administration: oral
16060245|NCT02453009|Drug|Enzalutamide|Pharmaceutical form : soft gelatin capsules Route of administration: oral
16060246|NCT02452996|Drug|GNbAC1|Single dose of IMP, IV infusion
16060247|NCT02452983|Drug|Sertraline|
16060248|NCT02452983|Procedure|Bone Marrow Aspirate/Biopsy|
16060249|NCT02452970|Drug|RRx-001|RRx-001 (10 mg/m2) intravenously twice weekly for up to six weeks followed by retreatment with Gemcitabine 1000 mg/m2 and Cisplatin 30 mg/m2 on Days 1 and 8 of a 21 Day Cycle until tumor progression
16060250|NCT02452970|Drug|Gemcitabine and cisplatin|RRx-001 (20 mg) intravenously weekly for up to six weeks followed by retreatment with Gemcitabine 1000 mg/m2 and Cisplatin 25 mg/m2 on Days 1 and 8 of a 21 Day Cycle until tumor progression
16060251|NCT02452944|Device|nerve stimulator (stimuplex HNS12)|whether using the nerve stimulator or not when the investigators do the ultrasound-guided obturator nerve block
16060252|NCT02452944|Device|ultrasound|we did obturator nerve block with ultrasound guided method for searching the fascias where the anterior and posterior branches of obturator nerve run.
16060253|NCT02452931|Drug|Leuprolide Acetate 45 mg|Subcutaneous injection
16060254|NCT02452918|Drug|Oritavancin|a single 1200 mg IV dose of Orbactiv (oritavancin)
16060255|NCT02452905|Drug|Nitazoxanide|
16060256|NCT02452905|Drug|Placebo (for Nitazoxanide)|
16060257|NCT02452892|Device|LFMS|Low field magnetic stimulation (1 kilohertz oscillating magnetic field) will be administered using a portable tabletop device capable of generating time-varying electromagnetic fields of LFMS. For sham therapy, the device will be on; however, no magnetic field stimulation will be delivered.
16060258|NCT02452879|Device|Electroacupuncture|For the deep needling acupoint group, needle on bilateral BL33 50-60mm with a 60°angle. A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3). Needle with 75mm long needle. An electric stimulator is put on. SDZ-V Hua Tuo Brand electric stimulator (produced by Suzhou Medical Instrument Co.Ltd). continuous wave(CW), 10Hz. Stop turning up the current intensity when patients could not stand. 3 times a week. Once every other day The treatment period lasts eight weeks. totally 24 times.30min/time.
16060259|NCT02452879|Device|Sham Electroacupuncture|with the patient in the prone position. The acupoint routine disinfection of skin, and then the fixed pad is adhered on the acupoint. The 1.5 inches blunt tip needle pierce through the fixed pad, then it reaches the surface of the skin, uniform lifting thrusting and twirling all 3 times but do not pierce the skin. Then connect the electric acupuncture apparatus with special power supply wire electrode (special power line as the middle wire cut, looks as normal; that electroacupuncture instrument display connected to the state, but the actual without electricity), in the bilateral Zhongliao points, Hui Yang points on the needle handle; the period of treatment and the other manipulation of the placebo group are same as the deep needling acupoint group.
16060260|NCT02452879|Drug|Solifenacin Succinate|made by the Anse Tailai Pharmaceutical (China) R & D limited company) 5mg / tablet
16060261|NCT02452866|Drug|SYM-1219|Administered with 4 ounces of unsweetened applesauce, and 8 ounces of water
16060262|NCT02452853|Procedure|HR|"HR:
~HR was carried out under general anesthesia using a right subcostal incision with a midline extension. Intraoperative ultrasound was routinely performed. Pringle's maneuver was routinely used with a clamp/unclamp time of 10 minutes/5 minutes.Thrombectomy was performed according to the location and extent of PVTT. The en bloc technique was used for patients if the portal vein branch could be ligated with a sufficient safety margin between its root and the tip of the thrombus"
16060263|NCT02452853|Drug|FOLFOX4|"FOLFOX4(Oxaliplatin + 5-Fluorouracil/Leucovorin):
~4 weeks after HR; Drug: Oxaliplatin + 5- Fluorouracil/Leucovorin Day 1: Oxaliplatin 85mg/m² 2h IV infusion, leucovorin 200mg/m² 2h IV infusion, 5-fluorouracil 400mg/m² IV bolus, 5-fluorouracil 600mg/m2 22h IV infusion.
~Day 2: Leucovorin 200mg/m² 2h IV infusion, 5-fluorouracil 400mg/m² IV bolus, 5-fluorouracil 600mg/m² 22h IV infusion. Repeated every 2 weeks"
16060265|NCT02452827|Other|Biomechanical parameters|
16060266|NCT02452827|Other|MRI|MRI of cervical spine
16060267|NCT02452801|Drug|ALKS 5461|Single dose, given orally
16060268|NCT02452788|Other|Pharmaceutical care|Pharmacist-provided education on medication adherence in hemodialysis patients.
16060269|NCT02452775|Biological|OC-L|
16060270|NCT02452775|Other|Montanide|
16060271|NCT02452775|Other|poly-ICLC (Hiltonol),|
16060272|NCT02452762|Drug|Vitamin D3|
16060273|NCT02452762|Drug|Placebo|
16060274|NCT02452749|Dietary Supplement|Cardiovascular health dietary supplement|Herbal/mineral dietary supplement
16060275|NCT02452736|Device|Resolute Integrity™ Zotarolimus-Eluting Coronary Stent System|
16060276|NCT02452723|Biological|ISC-hpNSC|
16060277|NCT02452710|Other|Placebo|Open-label placebo
16060278|NCT02452697|Biological|NK Cell enriched-DLI only|"The first NK cell-enriched DLI will be administered one to six months post transplant. The second NK cell-enriched DLI will be administered one to three months post the first infusion, in patients who have ≤ grade II aGVHD at the time of infusion and have not had unacceptable toxicities from the first infusion. Patients will continue on their stable dose of immunosuppressive agents started for therapy of acute GVHD before the NK cell-enriched DLI, and will not taper until at least 6 weeks following the each NK cell-enriched DLI (unless disease progression or patient toxicity from the agents requires earlier taper). The donor NK cells will be infused over 30 minutes intravenously.
~If signs of GVHD occur after NK cell-enriched DLI, immunosuppressive agents may be started."
16060622|NCT02450357|Other|RT-PCR|Use RT-PCR to test PBMCs/CTCs from volunteers/patients.
16060279|NCT02452697|Biological|NK-DLI + DUK-CPG-001|"DUK-CPG-001 was synthesized by Agilent Technologies (Boulder, CO) in 2013. Bulk DUK-CPG-001 has been resuspended in normal saline with a final concentration of 10 mg/mL, aliquoted into 0.75 mL (7.5 mg) per tube and stored at -20oC in the Investigational Chemotherapy Service pharmacy at Duke. DUK-CPG-001 will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI. The drug will be used within 4 hours of thawing.
~On the day of NK cell-enriched DLI, for those patients who are randomized to receive DUK-CPG-001, 0.5 mL (5 mg) aliquots of DUK-CPG-001 will be dispensed to nurse. It will be thawed at room temperature right before use and injected intravenously right after NK cell-enriched DLI."
16060280|NCT02452684|Drug|Eszopiclone|The usual dosage of eszopiclone is 2 mg per dose for adults and 1 mg per dose for elderly participants, taken orally before bedtime. The dosage may be adjusted according to the participant's symptoms, but a single dose should not exceed 3 mg in adults and 2 mg in elderly participants.
16060281|NCT02452658|Other|Changed menu|After making the hypothetical choice, participants will be exposed to a menu with changed calorie and price labels, as well as several other changes.
16060282|NCT02452645|Behavioral|Healthy Food and Physical Activity Environments|Tailored written materials, videos, telephone counseling, active toys
16060283|NCT02452645|Behavioral|Comparison Group|Written materials, videos, books, and telephone counseling.
16060284|NCT02452632|Drug|ASP1941|oral
16060285|NCT02452632|Drug|Placebo|oral
16060286|NCT02452619|Other|Hyperbaric oxygen therapy|Hyperbaric oxygen therapy
16060287|NCT02452606|Drug|Stalevo®|"Sleep disorders in Parkinson's disease
~Analysis by Parkinson's Disease Sleep Scale(PDSS) scores.
~If the PDSS score is improving at least 15 percent than the baseline score, It can be determined to be effective."
16060288|NCT02452593|Other|"Tibial stimulation and pelvic floor exercises"|A group will make tibial nerve stimulation and the other will make pelvic floor training. After 8 weeks the patients exchanges their therapeutic approaches for over 8 weeks
16060289|NCT02452580|Other|Family Centered Care|Neonatal intensive care toward premature infants and their parents in a unit physically and culturally optimized for parent-infant interaction 24 hours a day 7 days a week from birth to discharge.
16060290|NCT02452567|Other|Moderate (8-10%) diet-induced weight loss|MAL participants will meet with the study dietitian to lose ~8-10% of their body weight through diet-intervention.
16060291|NCT02452554|Other|Laboratory Biomarker Analysis|Correlative studies
16060292|NCT02452554|Biological|Lorvotuzumab Mertansine|Given IV
16060293|NCT02452554|Other|Pharmacological Study|Correlative studies
16060294|NCT02452541|Other|Prognostic tests|"Brain CT-Scan on day 1, 3 and 7
~Brain MRI on day 7
~SomatoSensory Evoked Potentials on day 7
~Electroencephalogram on day 7
~Serum biomarkers on day 1, 3 and 7
~Daily clinical exams"
16060295|NCT02452528|Drug|ARC-520|
16060296|NCT02452528|Drug|Placebo|
16060297|NCT02452528|Drug|Entecavir|0.5 or 1.0 mg/day orally
16060298|NCT02452528|Drug|Tenofovir|300 mg/day orally
16060299|NCT02452528|Drug|diphenhydramine|50 mg orally as pretreatment antihistamine
16060300|NCT02452515|Drug|BAY1142524|5 mg BAY1142524 or placebo given as 5 mg IR tablet twice daily for 2 weeks
16060301|NCT02452515|Drug|BAY1142524|10 mg BAY1142524 or placebo given as 2 x 5 mg IR tablets twice daily as for 2 weeks
16060302|NCT02452515|Drug|BAY1142524|25 mg BAY1142524 or placebo given as 5 x 5 mg IR tablets twice daily for 2 weeks
16060303|NCT02452515|Drug|BAY1142524|50 mg BAY1142524 or placebo given 1 x 50 mg IR tablet once daily for 2 weeks
16060304|NCT02452515|Drug|Placebo|The patients will be treated orally with combinations of IR tablets containing placebo to achieve the indicated dosages.
16060305|NCT02452502|Device|atorvastatin|Atorvastatin high or moderate dose daily for 2 weeks administrated within 24 hours after receiving rt-PA thrombolysis, continued statin use for at least 12 months
16060306|NCT02452489|Device|acupuncture|Patients will be acupuncture with Zhongwan(RN12),needle 1 times a day,30 min/time,5 days for a period of treatment,the treatment interval for two days,three intervention treatment,follow-up after 4 weeks.
16060307|NCT02452489|Device|acupuncture|Patients in Combination of He-Mu points group,will be acupuncture with Zusanli(ST36) and Zhongwan(RN12),needle 1 times a day,30 min/time,5 days for a period of treatment,the treatment interval for two days,three intervention treatment, follow-up after 4 weeks.
16060308|NCT02452489|Device|acupuncture|Patients in Control group,will be acupuncture with at the junction of deltoid and biceps,needle 1 times a day,30 min/time,5 days for a period of treatment,the treatment interval for two days,three intervention treatment,follow-up after 4 weeks.
16060309|NCT02452476|Drug|CHF5633|Rescue treatment (if needed)
16060310|NCT02452476|Drug|Poractant alfa|Rescue treatment (if needed)
16060311|NCT02452463|Biological|Durvalumab|Given IV
16060312|NCT02452463|Drug|Nintedanib|Given PO
16060313|NCT02452463|Other|Placebo|Given PO
16060314|NCT02452463|Procedure|Quality-of-Life Assessment|Ancillary studies
16060315|NCT02452450|Drug|Ibuprofen Acid|
16060316|NCT02452450|Drug|Ibuprofen Lysine|
16060317|NCT02452450|Drug|Ibuprofen Sodium|
16060318|NCT02452450|Drug|Ibuprofen Liquid Capsules|
16060319|NCT02452450|Drug|Paracetamol|
16060320|NCT02452437|Drug|Oxycodone|Controlled release oxycodone 40 mg twice daily
16060321|NCT02452424|Drug|PLX3397|PLX3397 capsules, 200 mg
16060322|NCT02452424|Biological|Pembrolizumab|Pembrolizumab, 200 mg, IV
16060323|NCT02452411|Behavioral|Cognitive Behavioral Treatment approach supported by virtual reality and positive psychology strategies.|The CBT program consists of 6 weekly sessions (and 2 additional ones depending on the patient's needs) with the following main therapeutic components: educational component, exposure/processing of the stressful event with VR (EMMA's World) and relapse prevention. EMMA's World is an open and flexible VR system that uses symbols (e.g., 3D-objects, pictures, sounds) to reflect and evoke the negative emotions associated to the stressful event. Also, several strategies from Positive Psychology (e.g., My best virtues or strengths exercise) and others based on Neimeyer's (2000) suggestions for pathological grief (e.g., projection letter to the future) are also included in the protocol.
16060324|NCT02452398|Device|Treatment group|The intense pulsed light (IPL) applicator with a wavelength of 690 nm and spot size (treatment area) of 30 mm by 10 mm will be used to deliver the energy to the treatment area.
16060325|NCT02452398|Other|No intervention|Subject will act as their own control where the baseline hair count will be used as a comparator to the hair count after treatment.
16060326|NCT02452385|Drug|CM082 tablet|CM082 tablets taken orally
16060327|NCT02452372|Drug|givosiran (ALN-AS1)|Single or multiple doses of ALN-AS1 by subcutaneous (sc) injection
16060328|NCT02452372|Drug|Sterile Normal Saline (0.9% NaCl)|calculated volume to match active comparator
16060329|NCT02452359|Device|Venus Versa|The Venus Versa system consists of a console and 4 detachable applicators that deliver optical energy in the form of Intense Pulsed Light to the patient skin. The intense pulsed light lamp delivers non-coherent light distributed over a range of wavelengths from 500 nm to 1200 nm. Different filters are embedded in the different applicators so that each applicator can deliver the desired spectrum according to the indications to be treated.In this study, the IPL applicator SR580 will be evaluated for the treatment of Striae Distensae, depending on the patient's skin type.
16060330|NCT02452346|Drug|Tosedostat|120 mg PO once daily continuously for each 28 day treatment cycle
16060331|NCT02452333|Procedure|Oncoplastic Approach Excisional Breast Biopsy|Evidence based quadrant by quadrant oncoplastic algorithm reinforced with videoscopic applications for peripheral lesions.
16060332|NCT02452333|Procedure|Conventional Excisional Breast Biopsy|Conventional Excisional Breast Biopsy
16060333|NCT02452333|Other|Tezel Method of Breast Volume Measurement|Tezel Method is a simple, accurate and non-invasive method of measuring differences in breast volume based on Archimedes' principle
16060334|NCT02452333|Other|Cosmetic Assessment|Cosmetic Assessment with Harris scale graded by patient, surgeon and professional third party. A standardised photograph of front, side and mediolateral oblique views will be taken using a digital camera for professional third party observers.
16060335|NCT02452320|Drug|intravenous acetaminophen|administration of 1000mg of intravenous acetaminophen or placebo every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia
16060336|NCT02452320|Drug|Placebo|Subjects randomized to placebo will receive every 6 hours for a total of 4 doses; first dose to be administered after induction of general anesthesia
16060337|NCT02452307|Biological|Peptide vaccine|subcutaneous
16060338|NCT02452307|Drug|Montanide ISA-51|subcutaneous
16060339|NCT02452307|Drug|Granulocyte macrophage colony stimulating factor (GM-CSF)|intradermal
16060340|NCT02452307|Drug|Imiquimod|epicutaneous
16060341|NCT02452307|Drug|mRNA|subcutaneous
16060342|NCT02452307|Drug|Protamin|subcutaneous
16060343|NCT02452307|Procedure|local hyperthermia|
16060344|NCT02452294|Drug|Buparlisib|Patients will receive oral buparlisib 100 mg once daily and continue on study treatment until evidence of disease progression, death, or unacceptable adverse events
16060345|NCT02452281|Drug|ipilimumab|3 mg/kg, IV one day (a minimum of 12 hours and not more than 48 hours) before HSPPC-96 every 21-25 days for a total of 4 cycles.
16060346|NCT02452281|Drug|HSPPC-96|25 μg by intradermal injection always 12 - 48 hours following ipilimumab on a weekly basis for the first 4 weeks and then every 3 weeks always 12 - 48 hours after ipilimumab; for at least 6 cycles of HSPPC-96 up to 12 doses.
16060347|NCT02452268|Drug|NIZ985|Subcutaneous administration of hetIL-15 three times a week for two consecutive weeks
16060348|NCT02452268|Drug|PDR001|• PDR001 is a human monoclonal antibody (MAb) administered day 1 of each cycle
16060349|NCT02452255|Drug|Fenofibrate|Fenofibrate by mouth given daily throughout hospitalization for up to 12 months
16060350|NCT02452255|Drug|Placebo|Placebo by mouth given daily throughout hospitalization for up to 12 months
16060351|NCT02452255|Drug|Propranolol|Propranolol by mouth given daily throughout hospitalization for up to 12 months
16060352|NCT02452242|Drug|ABX464|25, 50, 75, 100, 150 mg, i.e. 1, 2, 3, 4 or 6 capsules respectively, every 3 days or every day for 2 weeks
16060353|NCT02452242|Other|Placebo|1, 2, 3, 4 or 6 capsules respectively, every 3 days or every day for 2 weeks
16060354|NCT02452229|Other|Review of the Literature for Human Herpes Virus infections|"Review of the Medline database (PubMed and Ovid interface) for human herpes virus infections in burns as well as Web of Science interface.
~PRIMSA (preferred reporting items for systematic reviews and meta-analyses) guidelines and checklist were used."
16060355|NCT02452216|Drug|Ferumoxytol|Undergo ferumoxytol-enhanced MRI
16060356|NCT02452216|Other|Tissue Analysis|Correlative analysis for macrophage detection and quantification. This applies for all patients in the experimental arm who undergo ferumoxytol infusion.
16060357|NCT02452216|Procedure|Magnetic Resonance Imaging|All subjects in the experimental arm who undergo ferumoxytol infusion will subsequently have MRI.
16060358|NCT02452203|Behavioral|Floating|Floating in either a pool saturated with Epsom salt or in a zero-gravity chair
16060359|NCT02452190|Drug|Reslizumab|Reslizumab will be administered subcutaneously in a dose of 110 mg every 4 weeks.
16060360|NCT02452190|Drug|Placebo|Matching Placebo
16060361|NCT02452177|Drug|Vitamin D|
16060362|NCT02452164|Other|Teaching|
16060363|NCT02452164|Device|(CellScopeOTO)|
16060364|NCT02452151|Drug|Infliximab-Biosimilar|
16060365|NCT02452151|Drug|Infliximab-Innovator|
16060366|NCT02452138|Other|Severe sepsis management|
16060367|NCT02452125|Dietary Supplement|Nicotine gum|Nicotine chewing gum
16060368|NCT02452112|Drug|5% Lidocaine patch|5% Lidocaine patch to be placed on the site of pain
16060369|NCT02452112|Drug|Placebo|Placebo patch to be placed on the site of pain
16060370|NCT02452099|Procedure|Cryopreservation of HSCs using 5% DMSO concentration|Cryopreservation of HSCs obtained by leukapheresis will be performed using 5% DMSO concentration.
16060371|NCT02452099|Procedure|Cryopreservation of HSCs using 7,5% DMSO concentration|Cryopreservation of HSCs obtained by leukapheresis will be performed using 7,5% DMSO concentration.
16060372|NCT02452099|Procedure|Cryopreservation of HSCs using 10% DMSO concentration|Cryopreservation of HSCs obtained by leukapheresis will be performed using 10% DMSO concentration.
16060373|NCT02452086|Device|Low Level Laser(Ga-As)|Low level laser therapy(904 nm Wavelength), 90 milliwatt, 2 Joule/centimeter2
16060374|NCT02452086|Procedure|Placebo|LLLT with zero intensity
16060375|NCT02452073|Other|Thyroid function tests|
16060376|NCT02452060|Drug|Ketamine|0.4mg/kg infusion
16060378|NCT02452047|Drug|Imipenem+Cilastatin/Relebactam|Imipenem+Cilastatin/Relebactam 200/100 mg to 500/250 mg, depending on renal function, IV infusion once every 6 hours
16060379|NCT02452047|Drug|Colistimethate sodium (CMS)|Colistimethate base activity 300 mg (~720 mg CMS) IV infusion loading dose, followed by colistimethate base activity 75 mg to 150 mg (~180 to 360 mg CMS), depending on renal function, once every 12 hours
16060380|NCT02452047|Drug|Imipenem+Cilastatin|Imipenem+cilastatin 200 mg to 500 mg, depending on renal function, IV infusion once every 6 hours
16060381|NCT02452047|Drug|Placebo to CMS|Placebo to CMS IV infusion once every 12 hours
16060382|NCT02452034|Drug|Posaconazole IV solution|Posaconazole by IV solution twice on Day 1, then once daily on Days 2-10.
16060383|NCT02452034|Drug|Posaconazole powder for oral suspension|Posaconazole once daily by PFS for a minimum of 10 days
16060384|NCT02452008|Drug|Enzalutamide|160mg of enzalutamide is administered orally once a day on days 1-28 of each cycle.
16060385|NCT02452008|Drug|LY2157299|150 mg of LY2157299 is administered orally twice a day on days 1-14 of each cycle.
16060386|NCT02451995|Device|Ripple Mapping guided AT ablation|Diagnosing the mechanism and delivering ablation within the atria in patients with atrial tachycardia on the basis of Ripple Mapping
16060387|NCT02451995|Device|Local activation Time Mapping AT Ablation|Diagnosing the mechanism and delivering ablation within the atria in patients with atrial tachycardia on the basis of local activation time mapping
16060392|NCT02451969|Biological|investigational 23-valent PPV|The investigational vaccine was manufactured by Sinovac Biotech Co., Ltd.
16060393|NCT02451969|Biological|control 23-valent PPV|The control vaccine was manufactured by Chengdu Institute of Biological products Co., Ltd.
16060394|NCT02451956|Drug|AZD5363|Dosage and Schedule : AZD5363 400mg bid 4 days on/ 3 days off of a 7 day cycle for each week
16060395|NCT02451956|Drug|paclitaxel|paclitaxel 80mg/m2 given days 1, 8 and 15 of a 28 day cycle.
16060399|NCT02451930|Drug|Necitumumab|Administered IV
16060400|NCT02451930|Drug|Pembrolizumab|Administered IV
16060401|NCT02451917|Drug|Glargine insulin|The initial insulin dose for those randomized to IGlar was 80% of the total daily NPH dose that was being discontinued. All of them had pre-prandial Regular insulin switched to Lispro insulin (Humalog™, Lilly, Brazil), at the same dose as in use previously. After 24 weeks, basal insulins were switched; in other words, individuals on IGlar in the first period switched to INPH, and the doses of pre-meal insulin were sustained
16060402|NCT02451917|Drug|NPH insulin|The same total daily NPH insulin dose was maintained for those randomized to INPH. All of them had pre-prandial Regular insulin (Humulin R™, Lilly, Brazil) switched to Lispro insulin (Humalog™, Lilly, Brazil), at the same dose as in use previously. . After 24 weeks, basal insulins were switched; in other words, individuals on NPH in the first period switched to glargine insulin, and the doses of pre-meal insulin were sustained.
16060403|NCT02451904|Other|Observation|
16060404|NCT02451891|Biological|MVA-EBO Z|
16060405|NCT02451891|Biological|ChAd3-EBO Z|
16060406|NCT02451878|Behavioral|E-Couch|e-couch is an online CBT based intervention
16060407|NCT02451865|Drug|Binimetinib|Given PO
16060408|NCT02451865|Drug|Docetaxel|Given IV
16060409|NCT02451865|Other|Laboratory Biomarker Analysis|Correlative studies
16060410|NCT02451852|Drug|AZD9291|AZD9291 80mg tablet once daily, open label
16060411|NCT02451826|Drug|Ulipristal acetate|CVR delivering Ulipristal acetate and one tablet levonorgestrel.
16060412|NCT02451813|Procedure|Apposition of needle bevel against femoral nerve|Indentation of femoral nerve and fascia iliaca by block needle and measurement of opening injection pressure during the controlled injection of 1 ml of dextrose (D5W) solution
16060413|NCT02451800|Other|in-class yoga|In-person yoga classes that meet for 3x/week for 3 months. Each class is 1 hour.
16060414|NCT02451800|Other|yoga by DVD|Individuals are asked to follow a 1-hour DVD on yoga 3x/week for 3 months.
16060415|NCT02451800|Other|stretching by DVD|Individuals are asked to follow a 1-hour DVD on stretching exercises 3x/week for 3 months.
16060416|NCT02451787|Dietary Supplement|Vitamin D|2400 units per day for 3 months
16060417|NCT02451774|Drug|Pentoxifylline Plus Chemotherapy|Pentoxifylline 10 to 20 milligrams per kilogram, daily, for up to 32 days Chemotherapy: Prednisone 40 milligrams per square meter per day, orally, day 5-32. Vincristine 1.5 milligrams per square meter per week, intravenously, day 5, 12, 19, 26. Daunorubicin 25 milligrams per square meter per week, intravenously, days 5; 12. L-asparaginase 10,000 units for square meter, intramuscular, days 6, 8, 10, 12, 14, 16, 19, 21, 23. Cyclophosphamide 1000 milligrams per square meter per dose intravenously, day 26. Cytarabine 75 milligrams per square meter per dose intravenously, days 27-30, 34-37. 6-Mercaptopurine 60 milligrams per square meter per dose, orally, days 26-39, Mix: Methotrexate 8-12 milligrams, Hydrocortisone 16-24 milligrams and Cytarabine 24-36 milligrams, intrathecal, day 19.
16060418|NCT02451774|Drug|Placebo Plus Chemotherapy|Placebo daily, for up to 32 days Chemotherapy: Prednisone 40 milligrams per square meter per day, orally, day 5-32. Vincristine 1.5 milligrams per square meter per week, intravenously, day 5, 12, 19, 26. Daunorubicin 25 milligrams per square meter per week, intravenously, days 5; 12. L-asparaginase 10,000 units for square meter, intramuscular, days 6, 8, 10, 12, 14, 16, 19, 21, 23. Cyclophosphamide 1000 milligrams per square meter per dose intravenously, day 26. Cytarabine 75 milligrams per square meter per dose intravenously, days 27-30, 34-37. 6-Mercaptopurine 60 milligrams per square meter per dose, orally, days 26-39, Mix: Methotrexate 8-12 milligrams, Hydrocortisone 16-24 milligrams and Cytarabine 24-36 milligrams, intrathecal, day 19.
16060419|NCT02451761|Biological|Blood sampling|
16060420|NCT02451748|Other|Lab Work|Lab work to measure IL-7 and IL-7R
16060421|NCT02451748|Drug|Certolizumab pegol (CDP870, tradename Cimzia)(prefilled syringes at the dose of 200mg)|"Certolizumab pegol (CDP870, tradename Cimzia) or is provided in prefilled syringes at the dose of 200mg.
~Patients received 2x200mg at weeks 0, 2 and 4. Additionally a maintenance dose of 200mg is given every 2 weeks. Treatment is performed through subcutaneous injection."
16060422|NCT02451748|Drug|Certolizumab pegol (CDP870, tradename Cimzia)|"rtolizumab pegol (CDP870, tradename Cimzia) or is provided in prefilled syringes at the dose of 200mg.
~Patients received 2x200mg at weeks 0, 2 and 4. Additionally a maintenance dose of 200mg is given every 2 weeks. Treatment is performed through subcutaneous injection."
16060423|NCT02451748|Drug|Hydroxychloroquine|some patients are on 400mg/day of hydroxychloroquine.
16060424|NCT02451748|Drug|Sulfasalazine|some patients are on 300 mg/day and some patients are on 1000 mg/day dose of sulfasalazine
16060425|NCT02451748|Drug|Medrol|some patients are on 8mg/day of medrol
16060426|NCT02451748|Drug|Prednisone|some patients are on 10mg /day, some patients are on 20 mg/day, some patients are on 2.5 mg/day, some patients are on 30 mg/day, and some patients are on 5 mg/day of prednisone
16060427|NCT02451748|Drug|Triamcinolone|some patients are on Triamcinolone 40-80mg IM monthly (received 40mg dose 1 week before blood draw, off enbrel 50mg weekly and SSZ 1000mg bid for ~ 3 months) some patients are on Triamcinolone 40mg IM monthly
16060428|NCT02451748|Drug|Naproxen|some patients are on 1000 mg/day of naproxen
16060429|NCT02451748|Drug|Leflunomide|some patients are on 20mg/day of leflunomide
16060430|NCT02451748|Drug|Methotrexate|some patients are on 20mg weekly, some patients are on 25mg weekly, some patients are on 17.5 mg, some patients are on 15 mg weekly, some patients are on 7.5 mg weekly, and some patients are on 15 mg weekly dose of methotrexate
16060431|NCT02451748|Drug|humira|some patients are on Humira 40mg q2weeks
16060432|NCT02451735|Behavioral|Video and Booklet|Printed and DVD materials about Genetic Counseling. Self-reported feedback will be collected and reviewed to compare to the control group response.
16060433|NCT02451735|Behavioral|Factsheet|Patient factsheet about Genetic Counseling. Self-reported feedback will be collected and reviewed to compare to the intervention group response.
16060434|NCT02451722|Device|Kyboot shoes|The Kyboot shoe - construction is based on a soft, supple air cushioned sole. The honeycomb air structure of the kyBoot sole creates an air cushion between your foot and the ground, with one fifth of the volume of air being pumped into the foot area at every step. This design could offer a better distribution of pressure
16060435|NCT02451709|Device|Activated Smartinhaler or Smartturbo|Medication reminder alarms
16060436|NCT02451709|Other|Feedback of adherence data|Review of adherence data with action planning
16060437|NCT02451709|Device|Deactivated Smartinhaler or Smartturbo|Alarms deactivated and no feedback
16060438|NCT02451696|Drug|Everolimus|This study will measure if the drug called Everolimus effects mTOR signaling (an electrical activity signal in the brain) in patients with Tuberous Sclerosis Complex (TSC) and Focal Cortical Dysplasia (FCD) with treatment resistant epilepsy (TRE) who will be undergoing brain surgery. One group of patients will be treated with Everolimus, for 7-28 days prior to epilepsy surgery and another will not. We will determine if there is a difference in mTOR signaling between the patients who were treated with Everolimus and those who were not
16060439|NCT02451683|Other|Electrophysiology Assessment of Time Domain|Kinematics, Spinal Cord Excitability and Cortical Spinal Motor Excitability.
16060440|NCT02451683|Other|Electrophysiology Assessment of Location|Kinematics, Spinal Cord Excitability and Cortical Spinal Motor Excitability
16060441|NCT02451683|Other|Training with some stimulation|motor task combined with real or sham stimulation
16060442|NCT02451670|Behavioral|Prioritized Clinical Decision Support|After entry of blood pressure data at all primary care visits, relevant electronic health record data were automatically extracted, encrypted and processed through Web-based clinical algorithms that determined if the patient met intervention eligibility criteria. In intervention clinics, the rooming staff received a best practice alert and printed patient and primary care provider versions of the clinical decision support that identified evidence-based treatment options for any uncontrolled cardiovascular risk factors and prioritized treatment recommendations based on potential cardiovascular risk reduction. Cardiovascular risk factors addressed in study participants were control of lipids, blood pressure, weight, tobacco, glucose and appropriate aspirin use. In control clinics, rooming staff did not receive a best practice alert and patients and primary care providers did not receive and were not able to access the clinical decision support.
16060443|NCT02451657|Other|No Intervention|No intervention was administered in this study
16060444|NCT02451644|Device|pedometer|patient will cary pedometer
16060445|NCT02451631|Other|Traditional care with paper|Healthcare staff-driven care, Diabetes mgmt. guide-book provided. Patient self-monitoring of blood glucose(SMBG) with paper.
16060446|NCT02451631|Device|Health-on G App. + Physician Web|Patients use their smart-phone or receive rental phone, and download Health-On G application. Algorithm-based personalized feedback are provided when patients' data are linked to Health-On G Application. Patient self-monitoring blood glucose data from glucometer are transferred to App. automatically by bluetooth, or input manually, check medication regimen, input food intake and exercise, and step counts are linked by Activity tracker. Personalized feedback are instantly provided based on data. Entered data are also connected to web-based physician portal. Physician web portal is provided, where they're able to review their patient's all data. Health-On G is defined as a U-Healthcare medical device consisting of gateway and decision support system.
16060447|NCT02451605|Drug|Analgesic nerve blockade (Ropivacaine)|Analgesic nerve blockade (Ropivacaine) for total knee replacement surgery.
16060448|NCT02451605|Procedure|Total knee replacement surgery.|Total knee replacement surgery.
16060449|NCT02451579|Drug|Antihistamine Cetirizine Hydrochloride|Prophylactic use of antihistamine prior to and following topical 5-aminolevulonic acid photodynamic therapy
16060450|NCT02451579|Other|Placebo|Use of placebo prior to and following topical 5-aminolevulonic acid photodynamic therapy
16060451|NCT02451566|Device|Ovation Prime Abdominal Stent Graft System|
16060452|NCT02451553|Drug|Afatinib Dimaleate|Given PO
16060453|NCT02451553|Drug|Capecitabine|Given PO
16060454|NCT02451553|Other|Laboratory Biomarker Analysis|Correlative studies
16060455|NCT02451540|Radiation|HRCT scan|HRCT scan of thorax, at baseline and after 3 months
16060456|NCT02451540|Drug|Placebo of Roflumilast|Placebo, once a day in the morning during 3 months
16060457|NCT02451540|Drug|Roflumilast|Roflumilast, once a day in the morning during 3 months
16060458|NCT02451527|Drug|Digoxin|Digoxin 0.5mg tablet by mouth on Day 1 and Day 38
16060459|NCT02451527|Drug|PEX168|PEX168 in subcutaneous injection on Day8，15，22，29 and Day 36
16060460|NCT02451514|Biological|MenABCWY+OMV vaccine|Intramuscular injection of a single dose at Day 1 to subjects in the MenABCWY+OMV Group or as a 2 doses at Day 1 and Day 31, one month apart, to subjects in the MenACWY and Naive Groups.
16060461|NCT02451501|Device|AKITA|
16060462|NCT02451488|Drug|GM-CSF|14 days in a dose of 125 µg/m^2
16060463|NCT02451488|Other|Standard of Care|No neo-adjuvant therapy prior to surgical intervention
16060464|NCT02451475|Drug|Amitriptyline|Amitriptyline 25 mg/day
16060465|NCT02451475|Drug|Venlafaxine|Venlafaxine 75 mg/day
16060466|NCT02451475|Drug|Paroxetine|Paroxetine 25 mg/day
16060467|NCT02451462|Drug|Zoledronic acid|
16060468|NCT02451436|Behavioral|Sleep and Media Use Intervention|
16060469|NCT02451436|Behavioral|Study Skills Control Group|
16060470|NCT02451423|Drug|MPDL3280A Dose Level 1|1200 mg x 1 dose
16060471|NCT02451423|Drug|MPDL3280A Dose Level 2|1200 mg every 3 weeks x 2 doses
16060472|NCT02451423|Drug|MPDL3280A Dose Level 3|1200 mg evert 3 weeks x 3 doses
16060473|NCT02451410|Other|Nutrition and physical activity|The investigators will design an educational and behavioral program focused on health promotion. Didactic material will be developed for teachers and educational material will be developed for parents. For children, the investigators will design educational and playtime materials that encourage healthy eating and physical activity.
16060474|NCT02451384|Procedure|routine surgery|To observe if the surgeries can influence the countings of circulating tumor cells of the patients.
16060475|NCT02451384|Procedure|no-touch surgery|
16060476|NCT02451384|Procedure|laparoscopic surgery|
16060477|NCT02451371|Device|tDCS|2mA direct current, 20 minutes per session, 2 sessions per day with at least 3hours interval between sessions, a total of 10 tDCS sessions
16060478|NCT02451358|Biological|Quadrivalent Inactivated Influenza Vaccine (2016-2017 NH formulation), No Preservative|0.25 mL, Intramuscular
16060479|NCT02451358|Biological|Quadrivalent Inactivated Influenza Vaccine (2016 SH formulation), No Preservative|0.5 mL, Intramuscular
16060480|NCT02451358|Biological|Quadrivalent Inactivated Influenza Vaccine (2015-2016 NH formulation), No Preservative|0.5 mL, Intramuscular
16060481|NCT02451358|Biological|Quadrivalent Inactivated Influenza Vaccine (2015 SH formulation), No Preservative|0.5 mL, Intramuscular
16060482|NCT02451345|Behavioral|Personalized risk model+website+coaching intervention|"A health coach (members of the Patient Support Corps at the University of California San Francisco) will contact each subject individually to discuss his tailored/personalized web-portal report on his risk of aggressive disease and the pro/cons of treatment versus active surveillance.
~The contact between subject and the health coaches will be done before subject's visit with his primary urologist. Subjects will be asked to complete different questionnaires on four different occasions: one at first visit to the interactive secure web portal; one before coach's call; one after the coaching (after the urologist visit), and one at 6 months. The questionnaire after subject's visit with the urologist includes discussion about their management choice, decision quality, anxiety and satisfaction with care."
16060483|NCT02451332|Biological|inactivated seasonal flu vaccine|Women will receive the flu vaccine, and have capillary blood spots collected on day 0 and day 3.
16060484|NCT02451319|Procedure|Retrograde Intrarenal Surgery|Endoscopic treatment of Kidney Stones
16060485|NCT02451306|Drug|Quetiapine|See information in arm description.
16060486|NCT02451306|Drug|Placebo|See information in arm description.
16060487|NCT02451293|Drug|Melatonin (N-acetyl-5-methoxytryptamine)|
16060488|NCT02451293|Drug|Placebo|
16060489|NCT02451280|Procedure|Unilateral Hybrid Intervention|For the unilateral RT training, participants will practice with their affected arms following a unilateral training protocol of BMT for 45 minutes (Yang, et al., 2012). For the UAT training, participants will receive training of the affected UL in functional tasks with behavioral shaping for 45 minutes (Lin, Wu, et al., 2009).
16060490|NCT02451280|Procedure|Bilateral Hybrid Intervention|For the bilateral RT training, patients will focus on training involving both arms using the BMT robot for 45 minutes. During the 45 minutes BAT training, participants will receive training in tasks focusing on bilateral symmetric or alternating movements of both ULs.
16060491|NCT02451280|Procedure|Robot-Assisted Training|The RT intervention will be matched in duration and intensity with the hybrid interventions. Participants in the RT group will practice on the BMT with bilateral protocols for 90 minutes. The tasks will be tailored according to the level
16060492|NCT02451267|Other|physical therapy treatment with aerobic exercise|neck exercise strengthening program with neck massage and aerobic exercise (leg bicycling with relaxed shoulders)
16060493|NCT02451267|Other|physical therapy treatment|neck exercise strengthening program with neck massage
16060494|NCT02451254|Procedure|circumferential ablation|circumferential ablation of the pulmonary veins
16060495|NCT02451254|Device|SVT ablation|SVT ablation
16060496|NCT02451241|Other|acupuncture|electroacupuncture
16060497|NCT02451228|Other|Serial blood collection|Serial blood collection from IV for pharmacokinetic and pharmacodynamic analysis. No drug, device, or biologic intervention. Opportunistic.
16060498|NCT02451215|Device|Laser Interstitial Thermotherapy (LITT)|Magnetic resonance imaging (MRI)-guided laser interstitial thermal therapy (LITT) is a minimally invasive surgical option to treat CNS tumors. LITT uses laser energy delivered to a target (i.e. CNS tumor) through a fiberoptic catheter, which results in damage to intracellular proteins and DNA, and subsequent cell death. LITT provides a sharp demarcation between ablated and unharmed tissue, which, when combined with the ability to monitor and control the ablation via MR thermal imaging, results in a high level of precision and control.
16060499|NCT02451202|Procedure|Deep Neuromuscular Blockade|"During maintenance phase, if recovery after 1 Post-Tetanic-count (PTC) responses, a continuous infusion can be initiated to maintain deep NMB (TOF =0, PTC 1-2).
~At the end of surgery, continuous infusion Rocuronium and Propofol are discontinued and paralysis will be simultaneously reversed by Sugammadex 4mg/kg from PTC 1-2."
16060500|NCT02451202|Procedure|Moderate Neuromuscular Blockade|- During maintenance phase, if recovery at the presence of <10% of control T1 of TOF from initial doses of 0.6 mg rocuronium, a continuous infusion can be initiated to maintain TOF = 1 - 2. The initial pump rate will be set at 0.5 mg/kg per hour.
16060501|NCT02451202|Drug|Sugammadex|
16060502|NCT02451202|Drug|Rocuronium|
16063114|NCT02432014|Behavioral|Services as Usual|
16060503|NCT02451189|Dietary Supplement|Inulin acetate ester|Inulin acetate ester supplementation (10g/d) for 30 days. Appetite measurements on day 15 and oral glucose tolerance test (OGTT) on day 30.
16060504|NCT02451189|Dietary Supplement|Inulin propionate ester|Inulin propionate ester supplementation (10g/d) for 30 days. Appetite measurements on day 15 and OGTT on day 30.
16060505|NCT02451189|Dietary Supplement|Inulin butyrate ester|Inulin butyrate ester supplementation (10g/d) for 30 days. Appetite measurements on day 15 and OGTT on day 30.
16060506|NCT02451176|Device|Davol Bard Soft Mesh synthetic|soft mesh synthetic
16060507|NCT02451176|Device|LifeCell Strattice Reconstructive Tissue Biologic|biologic mesh
16060508|NCT02451163|Dietary Supplement|wheat polysaccharides|Consumed once daily for 12 weeks.
16060509|NCT02451163|Dietary Supplement|maltodextrin|Consumed once daily for 12 weeks.
16060510|NCT02451150|Drug|Azilsartan|Azilsartan tablets
16060511|NCT02451137|Drug|Insulin glargine, 300 U/ml|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
16060512|NCT02451137|Drug|Insulin glargine, 100 U/ml|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
16060513|NCT02451137|Drug|Insulin detemir|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
16060514|NCT02451137|Drug|Background Therapy|Anti-diabetic drugs at investigator discretion and consistent with local labeling guidelines for use with insulin.
16060515|NCT02451124|Device|non-endoscopic inflatable balloon for the esophagus|Undergo non-endoscopic brushing of the esophagus using a non-endoscopic inflatable balloon for the esophagus
16060516|NCT02451124|Other|Questionnaire Administration|Ancillary studies
16060517|NCT02451124|Other|Laboratory Biomarker Analysis|Correlative studies
16060518|NCT02451124|Procedure|esophagogastroduodenoscopy|Standard of care, patients digestive tract scoped post balloon brushing
16060519|NCT02451111|Drug|Ibrutinib|Patients will be instructed by the Investigator to take the amount of 560 mg Ibrutinib/Placebo (4 x 140 mg capsules) orally once daily with a glass of water at approximately the same time every day.
16060520|NCT02451111|Drug|Rituximab|Rituximab 375 mg/m2 has to be administered i.v. for the first four (4) infusions in all patients. After i.v. administration of Rituximab for the induction therapy, the administration mode can be changed to s.c. (1400 mg) in the maintenance phase dependent on the local standard of care.
16060521|NCT02451098|Drug|Atorvastatin10mg, Ezetimibe10mg|Atorvastatin10mg, Ezetimibe 10mg (Duration: 8weeks)
16060522|NCT02451098|Drug|Atorvastatin10mg, Ezetimibe placebo|Atorvastatin10mg, Ezetimibe placebo(Duration: 8 weeks)
16060523|NCT02451098|Drug|Atorvastatin20mg, Ezetimibe10mg|Atorvastatin20mg, Ezetimibe 10mg (Duration: 8weeks)
16060524|NCT02451098|Drug|Atorvastatin20mg, Ezetimibe placebo|Atorvastatin20mg, Ezetimibe placebo(Duration: 8weeks)
16060525|NCT02451098|Drug|Atorvastatin40mg, Ezetimibe10mg|Atorvastatin40mg, Ezetimibe 10mg (Duration: 8weeks)
16060526|NCT02451098|Drug|Atorvastatin40mg, Ezetimibe placebo|Atorvastatin40mg, Ezetimibe placebo(Duration: 8weeks)
16060527|NCT02451085|Behavioral|training with video therapy|training with video therapy
16060528|NCT02451085|Behavioral|conventional exercise|training in conventional way
16060529|NCT02451072|Drug|Placebo|Capsules containing mannitol looking identical to LSD per os
16060530|NCT02451072|Drug|LSD|100µg per os, single dose
16060531|NCT02451072|Drug|Ketanserin|40mg per os, single dose looking identical to LSD per os
16060532|NCT02451059|Behavioral|WE CARE survey|The WE CARE survey, consists of 14 questions used to identify seven unmet material needs (education, employment, food security, housing, childcare, household heat, language). The survey will be administered with patient's developmental screening forms at all health supervision visits from birth to two years of age. The office staff will instruct parents to give the WE CARE survey, along with the developmental screening tool, to their child's provider at the visit.
16060533|NCT02451059|Behavioral|WE CARE Community Resource Handout|Providers will be trained to review the WE CARE survey at health supervision visits and generate referrals thru the EMR. Specifically, they will receive a one-hour teaching session one week prior to the study implementation. The goals for the session will include providing an overview of pediatric practice guidelines, introducing the WE CARE survey, reviewing the referral process, and discussing the role of peer patient navigators. Study staff will conduct periodic booster sessions; study staff will also train new providers should there be staff turnover
16060534|NCT02451059|Behavioral|Patient Navigator|The peer patient navigator will offer guidance to families with accessing community resources. They will be available at least .5 days per week at intervention health centers to meet with families and offer guidance as well as be available via a hotline number. The navigator will speak with families and offer guidance on community resources and offer assistance with completing applications. In addition, they will offer to schedule and, if desired, accompany parents to the agencies. Interpreter services will be utilized at the health centers in case the navigator does not speak the parent's language. The navigator will also place an update note in the EMR within 1-month post-visit and one week after any contact with families.
16060535|NCT02451033|Drug|standard medical therapy|diuretics, albumin infusion, antibiotics, nutrition, and variceal banding wherever needed
16060536|NCT02451033|Drug|G-CSF|G-CSF at the dosage of 5 µg/Kg subcutaneously every 12 hr for five consecutive days then every 3 monthly for 3 days till 1 year
16060537|NCT02451033|Drug|Growth Hormone|Growth Hormone in low dose of 1unit sc daily for 1 year
16060538|NCT02451020|Other|Altitude exposure|Participants will stay for 3 weeks at an altitude of 3200 m
16060539|NCT02451007|Drug|lurbinectedin (PM01183)|
16060540|NCT02450994|Drug|Dexamethasone|
16060541|NCT02450994|Drug|Placebo|
16060542|NCT02450981|Drug|Bevacizumab (BCD-021)|Bevacizumab is a monoclonal antibody against vascular endothelial growth factor A (VEGF-A)
16060543|NCT02450968|Drug|Dexamethasone|
16060544|NCT02450968|Drug|Placebo|
16060545|NCT02450955|Other|Massage|A superficial massage was performed for 10 minutes in the cervical region consisting of gentle rubbing and kneading, five minutes prone and five minutes supine with a focus on cervical and suboccipital muscles in order to induce a global relaxation of the cervical and suboccipital region. Resting position. After the treatment, both groups rested for 10 minutes in a supine position with neutral ranges of neck flexion, extension, lateral flexion, and rotation.
16063115|NCT02432001|Procedure|Image-Guided Biopsies|
16060546|NCT02450955|Other|Occiput-Atlas-Axis Technique|This technique was applied as described previously and is used with the aim of restoring joint mobility between the occiput, atlas and axis. It is a structural technique applied bilaterally, performed on a vertical axis passing through the dens process of the axis without extension or flexion and very little side-bending. After the treatment, both groups rested for 10 minutes in a supine position with neutral ranges of neck flexion, extension, lateral flexion, and rotation.
16060547|NCT02450942|Drug|18F-FDS|18F-FDS were intravenously injected into the patients 1 h before the PET/CT scans
16060548|NCT02450903|Drug|LDK378|Oral LDK378 750mg once daily
16060549|NCT02450890|Drug|Placebo First, then ORADUR®|ORADUR®-Methylphenidate is available in three dosage forms (22mg, 33mg or 44mg). The optimal dose for each subject will be determined in the open-label titration period. After randomization, subjects will be subjected to the 4-week double-blind two-way cross-over treatment phase with 2 study periods (2 weeks of placebo and 2 weeks of ORADUR®-Methylphenidate oral capsule at the optimal dose, according to a pre-determined randomization schedule).
16060550|NCT02450890|Drug|ORADUR® First, then Placebo|ORADUR®-Methylphenidate is available in three dosage forms (22mg, 33mg or 44mg). The optimal dose for each subject will be determined in the open-label titration period. After randomization, subjects will be subjected to the 4-week double-blind two-way cross-over treatment phase with 2 study periods (2 weeks of placebo and 2 weeks of ORADUR®-Methylphenidate oral capsule at the optimal dose, according to a pre-determined randomization schedule).
16060551|NCT02450877|Drug|Azacitidine|
16060552|NCT02450877|Other|Control Arm|
16060553|NCT02450864|Other|ESWT|Preoperatively, the ROM of the shoulder is measure with the patient in a sitting position. A goniometer is used to measure the angle to which the patient could maximally passively forward flex or abduct the shoulder. External rotation and internal rotation of the shoulders are determined with the patient's arm in a resting position. The investigators assessed shoulder ROM using the SROMD. Normal shoulder ROM without scapular stabilization is considered to be 180° of forward flexion, 180° of abduction, 90° of external rotation, and 90° of internal rotation with the arm at the side. By summation of the measured deficit of ROM, the SROMD is obtained. Patients are defined as having shoulder stiffness if SROMD >270degrees.
16060554|NCT02450838|Biological|V180|Tetravalent recombinant subunit dengue vaccine; V180 will contain 10 µg, 10 µg, 10 µg, and 20 µg of the DENV1, DENV2, DENV3, and DENV4 antigens, respectively.
16060555|NCT02450838|Biological|Alhydrogel™|Aluminum hydroxide gel adjuvant
16060556|NCT02450838|Biological|Placebo|
16060557|NCT02450825|Procedure|Lung ultrasound examination on Day 1 and Day 2 to 4|A standardized lung ultrasound examination using the GE Vivid ultrasound system will be performed following the tomographic scan on Day 1 and repeated on Day 2 to 4. Correlation of ultrasound-based aeration scores will be done with lung aeration measured by computed tomographic images.
16060558|NCT02450825|Procedure|Lung ultrasound examination on Day 1|A standardized lung ultrasound examination using the GE Vivid ultrasound system will be performed following the tomographic scan on Day 1 only. Correlation of ultrasound-based aeration scores will be done with lung aeration measured by computed tomographic images.
16060559|NCT02450825|Device|GE Vivid Ultrasound system|The GE Vivid ultrasound system will be used for all lung ultrasound examinations performed in this study.
16060560|NCT02450812|Drug|Radium-223-dichloride (Xofigo, BAY88-8223)|according to Summary of Product Characteristics
16060561|NCT02450799|Device|Acrylic IOL|Acrylic IOL for long-term implantation in the cataract patient
16060562|NCT02450799|Device|Silicone IOL|Silicone IOL for long-term implantation in the cataract patient
16060563|NCT02450799|Device|PMMA IOL|Polymethylmethacrylate IOL for long-term implantation in the cataract patient
16060564|NCT02450786|Drug|Donepezil|Donepezil is started in patients with Parkinson's disease mild cognitive impairment with 5mg for 8 weeks followed by dose up to 10mg and then maintained for 40 weeks. Participants who are not tolerable to dose of 10mg due to any issues of adverse effects would be maintained with donepezil 5mg exclusively in remained period.
16060565|NCT02450773|Drug|Furosemide|40 mg furosemide on postpartum day 1-6
16060566|NCT02450773|Drug|Potassium chloride|20 meq potassium chloride on postpartum day 1-6
16060567|NCT02450773|Drug|Placebo #1|Placebo (for furosemide)
16060568|NCT02450773|Drug|Placebo #2|Placebo (for KCl)
16060569|NCT02450760|Other|Social incentive|Quantify adherence to 90 days of home blood pressure monitoring and to determine if a social incentive improves adherence
16060570|NCT02450747|Device|etafilcon A MULTIFOCAL|Subjects will wear the test lens for four weeks.
16060571|NCT02450734|Procedure|Ultrasound-guided intermediate cervical plexus block|
16060572|NCT02450721|Other|Biomarkers serum level measurement|"Biomarker serum level measurement was performed with ELISA using following kits: Lp-PL-A2 ELISA- Cloud-CloneCorp. (USA); PAPP-A ELISA- IBL (Germany); Lp (a) ELISA Kit-AssayPro (USA ), ADMA ELISA Kit- ImmunDiagnostik ( Germany); hsCRP ELISA- Biomerica (Germany); according to the manufacturer's instructions . Absorbance of standards and samples was measured with a microplate reader Bio-Tek (USA) at a wavelength specified by the kit manufacturer . The calculation of the determined biomarkers concentration was performed using the software SOFTmaxPRO."
16060573|NCT02450708|Genetic|KIR genotyping|
16060574|NCT02450708|Genetic|HLA genotyping|
16060575|NCT02450695|Device|rTMS|
16060576|NCT02450682|Drug|Apixaban|Anticoagulant agent for Atrial Fibrillation and undergo CIED generator change
16060577|NCT02450682|Drug|Warfarin|Anticoagulant agent for Atrial Fibrillation and undergo CIED generator change
16060578|NCT02450656|Drug|Afatinib|Tablet
16060579|NCT02450656|Drug|Selumetinib|Capsule
16060580|NCT02450656|Drug|Docetaxel|
16060581|NCT02450643|Other|Test extensively hydrolyzed formula|extensively hydrolyzed formula made with a new enzyme
16060582|NCT02450643|Other|Control extensively hydrolyzed formula|commercially available extensively hydrolyzed formula
16060623|NCT02450344|Behavioral|Interactive health promotion|An Internet quiz game competition utilising quiz questions related to alcohol
16060624|NCT02450344|Behavioral|Passive health promotion|An electronic package of information related to alcohol
16060625|NCT02450331|Drug|Atezolizumab|Atezolizumab will be administered at a dose of 1200 milligrams (mg).
16060626|NCT02450318|Other|Slow-paced walking|Subjects will walk on a treadmill at a slow pace for 47 minutes
16060583|NCT02450630|Behavioral|Strenghtened referral of children|Community awareness on referral+ trained private providers in using RDTs/ICCM to treat and refer sick children + supervision and regular meetings between the private and public sector.All health workers in the intervention arm will be trained on how to recognize and distinguish uncomplicated & severe malaria, supplying unit-dose packaged Coartem® to customers with uncomplicated malaria, and administration of rectal artesunate pre-referral treatment and referral for sick children with severe and complicated malaria, diarrhoea and pneumonia.Private outlets in intervention arm will be trained to improve diagnosis, treatment and referral of children. The intervention will thus contribute to better health seeking practices at a community level and improved quality of care in the private sector
16060584|NCT02450617|Behavioral|Conventional individual treatment|Individual psychotherapeutic treatment and case-management delivered by public outpatient clinics or private practicing psychologist/psychiatrist
16060585|NCT02450617|Behavioral|Stabilizing group treatment for PTSD|20 sessions group psychotherapy for patients with PTSD, focused on psychoeducation and skills-training.
16060586|NCT02450617|Behavioral|Stabilizing group treatment for Dissociative disorders|20 sessions group psychotherapy for patients with PTSD, focused on psychoeducation and skills-training
16060587|NCT02450604|Genetic|Diagnosis of Fabry disease|The diagnosis of Fabry disease necessitates biochemical enzymatic measures of alphagalactosidase A activity in males, and genetic analysis using direct sequencing of GLA in females.
16060588|NCT02450591|Drug|Erlotinib|
16060589|NCT02450591|Other|Local Therapies|Definitive local therapies include surgical resection, stereotactic radiosurgery, ablation and conventional radiation therapy
16060590|NCT02450578|Drug|DSM265 400mg|DSM265 400mg, single oral administration in a fed state
16060591|NCT02450578|Drug|Placebo to DSM265 400 mg|Placebo to DSM265 400mg, single oral administration in a fed state
16060592|NCT02450578|Biological|Plasmodium falciparum sporozoite challenge|IV Plasmodium falciparum sporozoites (3200) by direct venous inoculation
16060593|NCT02450578|Drug|Malarone|250 mg atovaquone, 100 mg proguanil hydrochloride
16060594|NCT02450565|Other|Questionnaire|
16060595|NCT02450552|Drug|Ezogabine|Potiga is FDA-approved for adjunctive treatment of partial-onset seizures in patients aged 18 years and older who have responded inadequately to several alternative treatments.
16060596|NCT02450552|Drug|Placebo|Matched placebo
16060597|NCT02450539|Drug|Abemaciclib|Administered orally
16060598|NCT02450539|Drug|Docetaxel|Administered IV
16060599|NCT02450526|Biological|Botulinum toxin type A|
16060600|NCT02450526|Biological|Botulinum toxin type A|
16060601|NCT02450526|Drug|Placebo|50 Units
16060602|NCT02450526|Drug|Placebo|20 Units
16060603|NCT02450513|Drug|Adalimumab|160 mg at week 0, 80 mg at week 2 and 40 mg every two weeks onwards
16060604|NCT02450500|Behavioral|Lifestyle counselling|This will consist of a web-based lifestyle app and personalised behaviour modification advice by a registered dietitian delivered via messaging. Participants will be issued with a pedometer and instructed to wear this daily. Participants will access web-based material on prediabetes through the lifestyle app. Contact between the dietitian and participants will consist of weekly messaging to facilitate changes in diet and activity behaviour through motivational and cognitive behavioural strategies. Changes in diet and activity levels will be recorded as personalised goals which will be monitored and reviewed by both the participants and dietitian. In addition participants will be encouraged to complete a food diary to self-monitor their progress against dietary recommendations.
16060605|NCT02450487|Drug|Piroxicam|After extraction of at least one third molar, 100 patients will be treated with Piroxicam (20 mg once daily for 4 days) for pain control, collect the saliva to be genotyped and phenotyped for CYP2C9 (by PCR) and their post-operative notes (pain, swelling, trismus, temperature) will be analyzed. For the pharmacokinetics of piroxicam saliva samples will be collected from 10 of these patients at different times after ingestion of a capsule of 20 mg Piroxicam (before, 1, 2, 3, 4, 5, 6, 8, 11, 24, 48 and 72 hours after ingestion).
16060606|NCT02450474|Device|Intermittent pneumatic compression device|Flowtron, Circulation Booster and Sports XL devices will be used.
16060607|NCT02450474|Device|Neuromuscular electrical stimulation|Flowtron, Circulation Booster and Sports XL devices will be used.
16060608|NCT02450461|Other|no intervention|
16060609|NCT02450448|Other|Flow cytometry (FCM)|Use FCM to test PBMCs/CTCs from volunteers/patients.
16060610|NCT02450448|Other|RT-PCR|Use RT-PCR to test PBMCs/CTCs from volunteers/patients.
16060611|NCT02450435|Other|Flow cytometry (FCM)|Use FCM to test PBMCs/CTCs from volunteers/patients.
16060612|NCT02450435|Other|RT-PCR|Use RT-PCR to test PBMCs/CTCs from volunteers/patients.
16060613|NCT02450422|Other|Flow cytometry (FCM)|Use FCM to test PBMCs/CTCs from volunteers/patients.
16060614|NCT02450422|Other|RT-PCR|Use RT-PCR to test PBMCs/CTCs from volunteers/patients.
16060615|NCT02450409|Procedure|Implantation of TKA using the gap technique|Implantation of total knee arthroplasty using a specific operative technique (GT) serving as control.
16060616|NCT02450409|Procedure|Implantation of TKA using anatomical alignment|Implantation of total knee arthroplasty using a specific operative technique (AA) being experimental.
16060617|NCT02450383|Drug|Acellular Dermal Matrix|Placement of acellular dermal matrix (Alloderm®) on the buccal/coronal aspect of the alveolar ridge at the time of implant placement, following a two-stage approach
16060618|NCT02450383|Procedure|Autologous subepithelial connective tissue graft|Placement of autologous subepithelial connective tissue graft on the buccal/coronal aspect of the alveolar ridge at the time of implant placement, following a two-stage approach
16060619|NCT02450370|Behavioral|Low FODMAP diet|Subjects in this group will follow a low FODMAP diet for up to 10 weeks. Foods that are high in oligosaccharides, disaccharides, monosaccharides and polyols will be avoided. They will receive 3 dietetic consultations at week 0,6 and 10. Dietary leaflets, including meal samples and Yes/No food lists will be provided.
16060620|NCT02450370|Behavioral|Conventional IBS diet group|Subjects in this group will follow a conventional diet for up to 10 weeks. They will receive 3 dietetic consultations at week 0,6 and 10. This diet will focus on small frequent meals, no skipping meals and dietary adjustments for bloatedness, diarrhea and constipation. Advice on intake of caffeine and alcohol will also be given. Dietary leaflets will be provided.
16060621|NCT02450357|Other|Flow cytometry (FCM)|Use FCM to test PBMCs/CTCs from volunteers/patients.
16060628|NCT02450279|Drug|technetium-99m - Diethylenetriaminepentaacetic acid|
16060629|NCT02450279|Device|Vibrating-mesh nebulizer|
16060630|NCT02450279|Device|Jet Nebulizer|
16060631|NCT02450279|Other|Planar scintigraphy|
16060632|NCT02450279|Other|Preoperative spirometry|
16060633|NCT02450266|Device|Systematic transrectal ultrasound-guided prostate biopsy|12-18 systematic biopsy cores
16060634|NCT02450266|Device|MRI/ultrasound fusion-guided prostate biopsy|2 targeted biopsy cores from each prostate lesion
16060635|NCT02450253|Drug|Tadalafil|single dose, 20 mg capsule p.o.
16060636|NCT02450253|Drug|Placebo|single dose, matching capsule p.o.
16060637|NCT02450253|Behavioral|Cognitive functioning tests|Cognitive function tests will be performed prior to MRI scan 1 performed prior to IMP dosing on 2 occasions as patient will act as their own control
16060638|NCT02450253|Behavioral|Neuropsychological tests|"Neuropsychological tests will be performed prior to pre IMP dose MRI scan & then parallel V2 of the tests repeated 3-5 post IMP dose and before 2nd MRI scan.
~Participants act as own controls as 1 IMP occasion will be placebo- 2nd IMP occasion will be active. 7-30 days apart"
16060639|NCT02450253|Other|MRI Scan - Arterial Spin Labelling|Pre and post IMP dose on 2 occasions to detect difference in blood flow in deep brain 4 MRI scans in total
16060640|NCT02450240|Behavioral|standardized diagnostic assessment|
16060641|NCT02450240|Behavioral|self-report questionnaires|
16060642|NCT02450240|Behavioral|behavioral tasks|
16060643|NCT02450240|Other|physiological measurements|
16060644|NCT02450240|Other|structural and functional magnetic resonance imaging and EEG|
16060645|NCT02450240|Other|biomarker and microbiome assessments|
16060646|NCT02450240|Other|blood to derive induced pluripotent stem cells|
16060647|NCT02450240|Other|genetic and epigenetic assessments|
16060648|NCT02450227|Dietary Supplement|Spinach - Whole leaf (10 mg lutein)|Identical spinach meals processed in two different ways by Frigodan, served alone or together with habitual diet
16060649|NCT02450227|Dietary Supplement|Spinach - Minced (10 mg/lutein)|Identical spinach meals processed in two different ways by Frigodan, served alone or together with habitual diet
16060650|NCT02450214|Drug|Saline|50 mL syringe will be infused at 0.3 mL/Kg in bolus and then 0.15 mL/Kg/h 100 mL flask will be infused at 1mL/Kg in bolus for 30 min and then 0.25mL/Kg/h
16060651|NCT02450214|Drug|Ketamine|50 mL syringe will be infused at 0.3 mL/Kg in bolus and then 0.15 mL/Kg/h 100 mL flask will be infused at 1mL/Kg in bolus for 30 min and then 0.25mL/Kg/h
16060652|NCT02450214|Drug|Ketamine + magnesium|50 mL syringe will be infused at 0.3 mL/Kg in bolus and then 0.15 mL/Kg/h 100 mL flask will be infused at 1mL/Kg in bolus for 30 min and then 0.25mL/Kg/h
16060653|NCT02450201|Drug|Pyruvate|
16060654|NCT02450188|Drug|Vardenafil|"In this study we used Vardenafil 10 mg orodispersible tablets. These are the only orodispersible tablets on commerce indicated for the treatment of ED. We choose this kind of tablets because of their easy way of assumption that can also have a minor psychological impact on patients.
~Male patients will begin taking Vardenafil 10 mg orodispersible tablets 2 times a week for 10 weeks."
16060655|NCT02450188|Behavioral|CBST|"The CBST cognitive intervention, in according with Beck (1976), includes to help patients and their partners to gain a commonsense understanding and reframe their problems.
~On the other side, the CBST behaviour intervention, how described by Meichenbaum (1993), is a method to teach patients to practice different behaviours that allows the replacement of the compromised behaviour with a functional one.
~CBST interventions used in this study includes: psycho-educational interventions on ED maintaining, on anxiety's role and sexual homework. This course is structured in 10 weekly meetings. Male patients will begin taking Vardenafil 10 mg orodispersible tablets 2 times a week for 10 weeks."
16060656|NCT02450175|Drug|Everolimus|10 mg of Everolimus daily (by mouth)
16060657|NCT02450175|Drug|Letrozole|2.5mg taken daily (by mouth)
16060658|NCT02450162|Procedure|lateral rectus recession (bilateral)|Two types of recession (conventional or hang-back method) are typical surgeries for correcting intermittent exotropia. It depends on surgeon's decision at the time of surgery.
16060659|NCT02450149|Drug|sorafenib|
16060660|NCT02450136|Drug|pazopanib|
16060661|NCT02450123|Drug|sunitinib|
16060662|NCT02450110|Device|Spinal cord stimulation|
16060663|NCT02450097|Other|Caloric restriction|
16060664|NCT02450084|Procedure|Rectus sheath block|Ultrasound-guided bilateral rectus sheath block of RSB group using 0.25% Ropivacaine
16060665|NCT02450084|Drug|Ropivacaine|Ultrasound-guided bilateral rectus sheath block of RSB group using 0.25% Ropivacaine
16060666|NCT02450084|Other|Bandage|After the surgery, a bandage will be attached on injection site where is same as the incision site of surgery.
16060667|NCT02450084|Drug|IV-PCA containing Fentanyl|All patients will use total 100 ml of IV-PCA containing 800 µg of fentanyl for 48 hours postoperatively.
16060668|NCT02450058|Drug|5-fluorouracil|600 mg/m2 intravenously on day 1, every 21 days for six cycles
16060669|NCT02450058|Drug|epirubicin|60 mg/m2 intravenously on day 1, every 21 days for six cyles
16060670|NCT02450058|Drug|cyclophosphamide|600 mg/m2, intravenously on day 1, every 21 days for six cycles
16060671|NCT02450058|Drug|epirubicin|90 mg/m2 on day 1, every 21 days for four cycles
16060672|NCT02450058|Drug|paclitaxel|175 mg/m2, 3-hour infusion on day 1, every 21 days for four cycles
16060673|NCT02450045|Procedure|Continuous femoral nerve block|
16060674|NCT02450045|Drug|0.5% Ropivacaine/0.125% Bupivacaine local anesthetic mixture|
16060675|NCT02450032|Biological|G17DT|
16060676|NCT02450019|Procedure|Traditional to protective ventilation|Traditional ventilation will be set with 9 ml/kg with predicted body weight of tidal volumes and no PEEP and switched to protective ventilation after intracranial pressure measurement.
16060677|NCT02450019|Procedure|Protective to traditional ventilation|Protective ventilation will be set with 7 ml/kg tidal volume, 5 cm H2O PEEP, and 0.4 inspired O2 fraction (FiO2), and switched to traditional ventilation after intracranial pressure measurement.
16060678|NCT02449993|Device|MammaTyper™|MammaTyper™ is an in vitro molecular diagnostic test for the quantitative detection of the biomarkers estrogen receptor (ESR1), progesterone receptor ( PgR), Human epidermal growth factor receptor 2 (HER2) and proliferation antigen Ki-67 on the basis of the values of the messenger ribonucleic acid (mRNA).
16060679|NCT02449980|Procedure|Primary Surgery Group|Patients will receive surgical intervention during the initial hospital admission, as previously described, for the spontaneous pneumothorax. Patients will then be admitted postoperatively and monitored until discharge criteria are met
16060680|NCT02449980|Procedure|Initial Non-operative management|Patients will receive percutaneous drainage or chest tube placement as initial management for spontaneous pneumothorax. This will be followed by an observation period until discharge criteria are met.
16060681|NCT02449967|Procedure|interventional therapy|pancreatic cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）
16060682|NCT02449954|Drug|Intravenous morphine sulphate|Group I:received IV 0.1mg/kg morphine sulphate.
16060683|NCT02449954|Drug|Intravenous tramadol HCL|Group II:received IV 2 mg/kg tramadol HCL.
16060684|NCT02449954|Drug|Intravenous ketorolac tromethamine|Group III: received IV 30 mg ketorolac tromethamine
16060685|NCT02449941|Drug|PPI (proton pump inhibitor)|"Pre ESD (endoscopic submucosal dissection)
~Assessment atrophy and metaplasia in stomach, Check Helicobacter pylori
~Use of PPI for 2 months
~Post ESD 1 (After 2 months)
~Assess the distribution of helicobacter pylori after using PPI.
~Stop of PPI
~Post ESD 2 (After 4 months)
~Assess the distribution of helicobacter pylori after stop of PPI."
16060686|NCT02449928|Drug|sodium lactate Ringer's injection(Baxter, ShangHai, China)|use sodium lactate Ringer's injection to resuscitate the septic shock patients(lactate group)
16060687|NCT02449928|Drug|Compound Sodium Chloride Injection (CR Double-Crane, Beijing, China)|use Compound Sodium Chloride injection to resuscitate the septic shock patients(control group)
16060688|NCT02449915|Drug|Bupivacaine|At the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure), those subjects in the liposomal bupivacaine arm will have 30mL dilutional volume injected. Ten mL will be injected into the perineum in the posterior vaginal area and 20 mL will be injected the port site wounds in the abdomen (5 sites, 4 ml per incision).
16060689|NCT02449915|Drug|Placebo|At the completion of the procedure, and at least 20 minutes after the injection of lidocaine with epinephrine (routine for the surgical procedure), those subjects in the placebo arm will have 30mL total volume injected. Ten mL will be injected into the perineum in the posterior vaginal area and 20 mL will be injected the port site wounds in the abdomen (5 sites, 4 ml per incision).
16060690|NCT02449902|Drug|Estradiol|1 10 µg capsule inserted vaginally for 14 days.
16060691|NCT02449902|Drug|placebo|1 placebo capsule inserted vaginally for 14 days.
16060692|NCT02449889|Drug|highly purified human chorionic gonadotropin|
16060693|NCT02449889|Drug|recombinant human chorionic gonadotropin|
16060694|NCT02449876|Other|Neuroscience Education|"The following topics will be discussed in the education
~Basic structure of the nervous system
~Basic physiology of the nervous system
~The function and importance of pain
~Strategies to lessen the impact of pain
~The instruction will be delivered in an interactive manner so that questions are addressed immediately. At the conclusion of the session each subject will receive the book: Why Do I Hurt by Adriaan Louw to reinforce the information discussed in the session. Subjects will be asked to read the 50 page book prior to the second session.
~Session 2:
~The session will begin with a review of the topics discussed in Session 1 and contained in the book. Subject will be encouraged to ask questions and get clarification on any of the topics that are unclear."
16060695|NCT02449863|Other|Lung ultrasound|Lung ultrasound performed to newborns with respiratory distress
16060696|NCT02449850|Other|Food intervention|Intervention; systematic introduction of egg, milk, wheat and peanut by 4 months of age
16060697|NCT02449850|Other|Skin care|Bath with bath-oil aim and Ceridal face cream for least 5 times/ week from 0.5-9 months of age.
16060699|NCT02449824|Other|magnetic resonance imaging|early MRI
16060700|NCT02449811|Drug|Perindopril|
16060701|NCT02449811|Drug|Olmesartan|
16060702|NCT02449811|Drug|Amlodipine|
16060703|NCT02449811|Drug|Hydrochlorothiazide|
16060704|NCT02449798|Device|"AccuCath 2.25 BC Intravascular Catheter"|Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance.
16060705|NCT02449785|Device|MR measurements of lung morphological changes in cystic fibrosis (Avanto dot, Siemens)|
16060706|NCT02449785|Device|CT measurements of lung morphological changes in cystic fibrosis|
16060707|NCT02449772|Other|No intervention|No intervention
16060708|NCT02449759|Behavioral|ACT Intervention Group|A six chapter, 58 page self-help manual based on the principles of Acceptance and Commitment Therapy
16060709|NCT02449746|Biological|Plasma Exchange|PLEX is a procedure in which the subject's blood is passed through a medical device which separates out plasma from the other blood components, and replaces the plasma with albumin or plasma or other colloid. PLEX therefore removes circulating pathogenic antibodies, and furthermore therapeutic benefit after PLEX supports an antibody mediated pathogenesis of disease. In PLEX, 200-250 mL plasma per kg body weight is exchanged typically over 7-14 days using 5% albumin as replacement, often at alternate days which increases the amount of immunoglobulin removed due to equilibrium effects. PLEX modality (centrifugation or filtration), type of anticoagulation, and dose scheduling will be determined by local centre practice.
16060710|NCT02449746|Biological|Intravenous immunoglobulin|"Active Comparator: Intravenous Immunoglobulin (IVIG) IVIG is a pooled blood product from 3000-100,000 human blood donors with direct immunomodulatory effects.
~IVIG will be given at a dose of 2g/kg over 4 days. Dosing at 2g/kg is established in neurological disorders, with limited evidence that lower doses are less effective although adequate dosing studies have not been performed."
16060711|NCT02449733|Behavioral|Condom choices|Men will receive the condom package that includes an assortment of styles, sizes, features and colors at their baseline visit, and will be able to get more condoms for free at any time after that visit by coming to a study clinic during clinic hours, or during a scheduled study visit.
16060750|NCT02449577|Other|Beverage sequence BADC|Participants receive test beverages in the randomised order BADC
16060751|NCT02449577|Other|Beverage sequence ACDB|Participants receive test beverages in the randomised order ACDB
16060712|NCT02449733|Behavioral|Condom-compatible lubricant choices|Men will receive condom-compatible lubricant that will include different types of lubricant (e.g., silicone-based) and different packaging (individual sachets or flat, discreet packages) at their baseline study visit, and participants will be able to access enhanced condom-compatible lubricant at any time after that visit by coming to a study clinic during clinic hours, or during a scheduled study visit.
16060713|NCT02449733|Behavioral|Couples HIV counseling and testing (CVCT)|Participants will be invited to schedule couples voluntary HIV counseling and testing (CVCT) appointments with a clinic counselor at any point after they complete their baseline study visit.
16060714|NCT02449733|Drug|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|"FTC/TDF is a once daily oral tablet taken with or without food. The tablet includes 200 mg of emtricitabine (FTC) and 300 mg of tenofovir disoproxil fumarate (TDF).
~For men who meet eligibility criteria, Pre-exposure prophylaxis (PrEP) with Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) will be made available beginning one month into the study. Men who express interest and meet eligibility criteria at their baseline visit can initiate PrEP at 1 month if they test negative for HIV. For men with extenuating circumstances, whose risk profile changes, of those who become more comfortable with the PrEP intervention through enrollment in the study, PrEP will be available to initiate at the 4 month visit."
16060715|NCT02449733|Other|HIV Testing|Rapid HIV testing at multiple time points
16060716|NCT02449733|Other|Linkage to care|Men will be linked to needed services including HIV care and treatment for positives identified at baseline or during the study, including antiretroviral medications, and mental health services. At the end of their baseline visit, participants will receive service referral handouts for HIV care and treatment, mental health services, and other resources, as appropriate. Men who test positive for sexually transmitted infections (STIs )will be treated at the clinic site.
16060717|NCT02449733|Procedure|Post-exposure prophylaxis (PEP)|Two to three antiretroviral medicines as soon as possible (recommended is emtricitabine/tenofovir disoproxil fumarate plus either raltegravir or dolutegravir), but no more than 72 hours (3 days) after one may have been exposed to HIV, to try to reduce the chance of becoming HIV-positive. They must be taken for 28 days.
16060718|NCT02449733|Behavioral|Risk-reduction counseling|Risk-reduction counseling will be provided to all men at baseline and additionally at 3, 6, and 12 month visits, with an additional counseling session for men on PrEP at their initiation visit (either month 1 or 4), their 1-month follow-up visit (either month 2 or 5) and at their 9 month visit. Risk reduction counseling will be client-centered counseling, according to CDC's Fundamentals of HIV Prevention Counseling protocol.
16060719|NCT02449720|Drug|Ropivacaine|Intraperitoneal instillation and infusion
16060720|NCT02449720|Drug|0.9% Saline|Intraperitoneal instillation and infusion
16060721|NCT02449707|Procedure|Lateral Window Technique Augmentation for Maxillary Sinus|Maxillary sinus augmentation will be performed using the lateral window technique
16060722|NCT02449707|Device|Ultrasound activated resorbable poly-D-L-lactide pins|The titanium membrane placed during the maxillary sinus augmentation procedure will be stabilized using ultrasound activated resorbable poly-D-L-lactide pins
16060723|NCT02449707|Device|Purus® Cancellous Allograft|Allograft material placed in the sinus to acheive sinus augmentation
16060724|NCT02449707|Device|Resorb X Membrane|The membrane placed over the graft material before placement of the ultrasound activated pins
16060725|NCT02449707|Device|Biomend|Collagen healing membrane placed over the graft material on the side where no ultrasound activated pins are being used
16060726|NCT02449707|Procedure|Cone Beam CT image of the Sinus|Cone beam CT will used to assess the thickness of bone formation after the placement of the graft
16060727|NCT02449707|Procedure|Trephine Biopsy|Trephine Biopsy will be performed at the time of the placement of implant to study the quality of bone formed
16060728|NCT02449694|Device|OCS Liver|OCS Liver will be used to preserve the donor liver
16060729|NCT02449681|Drug|TH-4000|
16060730|NCT02449668|Device|Acupuncture|Acupuncture techniques with a plastic insertion tube was used to introduce every needle. The needles were perpendicularly inserted to a depth of 2-3 cm. The needles were applied to the area of the injured shoulder while the patient was lying in a lateral decubitus position on the stretcher. The skin was prepared with clorhexidine and the needles were sterile. They measured 40 mm long and 0.25 mm in diameter. The sessions lasted 20 minutes and the Qi sensation was sought by consistent manipulations, with rotation of the needles in both senses and scratching of the handle.
16060731|NCT02449668|Device|Sham Acupuncture|
16060732|NCT02449655|Drug|AZD5363|AZD5363 4800mg bid 4 days on/ 3 days off of a 7 day cycle for each week
16060733|NCT02449655|Drug|paclitaxel|paclitaxel 80mg/m2 given days 1, 8 and 15 of a 28 day cycle
16060734|NCT02449655|Drug|AZD2014|AZD2014 50mg BD 3 days on 4 days off of a 7 day cycle
16060735|NCT02449655|Drug|paclitaxel|paclitaxel 80mg/m2 given days 1, 8 and 15 of a 28 day cycle
16060736|NCT02449616|Drug|MST-188|Intravenous administration as 100 mg/kg for 1 hour followed by 30 mg/kg/hour for up to 48 hours.
16060737|NCT02449603|Drug|Exenatide|
16060738|NCT02449603|Drug|Biphasic insulin Aspart 30|
16060739|NCT02449590|Dietary Supplement|Onion powder|Hot meals with onion powder; 10 g/day onion powder corresponding to 100 g/day fresh onion in meals with potato and beef Intervention period 14 days.
16060740|NCT02449590|Dietary Supplement|Placebo|Hot meals without onion powder; Control meal with potato, beef, soy protein, and sucrose to match macronutrient composition of active treatment
16060741|NCT02449577|Other|Beverage sequence ABCD|Participants receive test beverages in the randomised order ABCD
16060742|NCT02449577|Other|Beverage sequence CADB|Participants receive test beverages in the randomised order CADB
16060743|NCT02449577|Other|Beverage sequence DACB|Participants receive test beverages in the randomised order DACB
16060744|NCT02449577|Other|Beverage sequence CBAD|Participants receive test beverages in the randomised order CBAD
16060745|NCT02449577|Other|Beverage sequence ABDC|Participants receive test beverages in the randomised order ABDC
16060746|NCT02449577|Other|Beverage sequence DABC|Participants receive test beverages in the randomised order DABC
16060747|NCT02449577|Other|Beverage sequence DCAB|Participants receive test beverages in the randomised order DCAB
16060748|NCT02449577|Other|Beverage sequence DBCA|Participants receive test beverages in the randomised order BDCA
16060749|NCT02449577|Other|Beverage sequence ADCB|Participants receive test beverages in the randomised order ADCB
16060753|NCT02449551|Drug|Volitinib|Volitinib is an orally available, potent, selective, small molecule c-MET inhibitor. Volitinib 800 mg will be administered orally once a day for 21 days as one cycle.
16060754|NCT02449538|Drug|everolimus|everolimus 10 mg qd daily one cycle is 28days.
16060755|NCT02449525|Procedure|Perfusion of flaps by a special bypass system|Free flaps are perfused via a special bypass perfused by a new technique supported by a intermittent perfusion support system.
16060756|NCT02449486|Drug|Ropivacaine|
16060757|NCT02449473|Biological|Tralokinumab|Subcutaneous Injection
16060758|NCT02449473|Other|Placebo|Subcutaneous Injection
16060759|NCT02449447|Behavioral|Cognitive behavioral therapy|CBT based on behavioral activation and cognitive therapy techniques including homework
16060760|NCT02449447|Other|Treatment as usual|Treatment as usual in primary care including antidepressants and counselling
16060761|NCT02449421|Behavioral|Quality Improvement Learning Community|Consultation with CPT experts to effectively use evidence-based psychotherapy.
16060762|NCT02449421|Behavioral|Fidelity-oriented Learning Community|The Fidelity-oriented Learning Community arm will receive fidelity consultation (adherence and competence) feedback by a CPT expert via online meetings.
16060763|NCT02449408|Other|Measurement of leptin and adiponectin obtained through blood sampling via venipuncture or finger/heelstick using novel screening tool|
16060764|NCT02449382|Procedure|continuous venovenous hemofiltration|If the serum sodium concentration >150mmol/L, When filter occurred clotting, replace the filter to CVVH treatment
16060765|NCT02449382|Drug|Control group|If the serum sodium concentration ≤150mmol/L, When filter occurred clotting, as the end of treatment.
16060766|NCT02449369|Drug|Preop acetaminophen IV|
16060767|NCT02449369|Drug|Preop orphenadrine IV|
16060768|NCT02449369|Drug|Postop oral oxycodone & acetaminophen|
16060769|NCT02449369|Drug|Postop hydromorphone IV|
16060770|NCT02449369|Drug|Postop oral orphenadrine|
16060771|NCT02449369|Drug|Postop oral oxycodone|
16060772|NCT02449369|Drug|Postop acetaminophen IV|
16060773|NCT02449369|Drug|Postop orphenadrine IV|
16060774|NCT02449356|Device|prone position endotracheal tube(PPT)|some special kind of endotracheal tube,including traditional air tube ,fixed device, fixed rope, and two through holes
16060775|NCT02449343|Drug|Anlotinib|Anlotinib p.o. qd
16060776|NCT02449343|Drug|Placebo|Placebo p.o. qd
16060777|NCT02449330|Drug|Teneligliptin|
16060778|NCT02449317|Other|Bioimpedance guided|"bioelectrical impedance analysis guided hydration therapy : 7.5% Sodium bicarbonate 150 ml + 5% dextrose in water 850 ml IV in 6 hours rate was adjusted regarding to extracellular water/total body water
~extracellular water/total body water < 0.36 : 4 ml/kg/hr
~extracellular water/total body water 0.36-0.4 : 2 ml/kg/hr
~extracellular water/total body water > 0.4 : 1 ml/kg/hr"
16060779|NCT02449317|Other|standard hydration|standard hydration : 7.5%Sodium bicarbonate 150 ml + 5% dextrose in water 850 ml IV 1 ml/kg/hr in 6 hours
16060780|NCT02449304|Device|Endometrial ablation (4th gen)|Radiofrequency Bipolar endometrial ablation device that is inserted into the uterine cavity to destroy the endometrial lining
16060781|NCT02449291|Drug|APD421|
16060782|NCT02449291|Drug|Placebo|
16060783|NCT02449278|Radiation|Consolidation involved-site radiotherapy (ISRT)|"6 cycles modern CHOP chemotherapy followed consolidation involved-site radiotherapy (ISRT).
~Involved-site radiotherapy (ISRT) is based on defining the site of gross disease before chemotherapy, the GTV and using a CT-based volume with an expansion to form a CTV in the cranio-caudal direction.
~The general dose had been guided that 30-36Gy in 15~18 fractions of 2 Gy 5 days per week was managed for patients with complete response (CR) after chemotherapy and 40-50Gy in 20~25 fractions of 2 Gy 5 days per week for partial response (PR)."
16060784|NCT02449278|Radiation|Consolidation involved-field radiotherapy (IFRT)|"6 cycles modern CHOP chemotherapy followed consolidation involved-field radiotherapy (IFRT).
~Radiotherapy field of IFRT defined by CALGB is encompassed the prechemotherapy gross tumor.
~The general dose had been guided that 30-36Gy in 15~18 fractions of 2 Gy 5 days per week was managed for patients with complete response (CR) after chemotherapy and 40-50Gy in 20~25 fractions of 2 Gy 5 days per week for partial response (PR)."
16060785|NCT02449278|Drug|cyclophosphamide|Patients in both arms will be given cyclophosphamide chemotherapy
16060786|NCT02449278|Drug|doxorubicin|Patients in both arms will be given doxorubicin chemotherapy
16060787|NCT02449278|Drug|vincristine|Patients in both arms will be given vincristine chemotherapy
16060788|NCT02449278|Drug|prednisone|Patients in both arms will be given prednisone chemotherapy
16060789|NCT02449265|Radiation|Consolidation involved-site radiotherapy (ISRT)|"6 cycles modern CHOP chemotherapy. Involved-site radiotherapy (ISRT) is based on defining the site of gross disease before chemotherapy, the GTV and using a CT-based volume with an expansion to form a CTV in the cranio-caudal direction.
~The general dose had been guided that 30-36Gy in 15~18 fractions of 2 Gy 5 days per week was managed for patients with complete response (CR) after chemotherapy and 40-50Gy in 20~25 fractions of 2 Gy 5 days per week for partial response (PR)."
16060790|NCT02449265|Radiation|Consolidation involved-field radiotherapy (IFRT)|"6 cycles modern CHOP chemotherapy. Radiotherapy field of IFRT defined by CALGB is encompassed the prechemotherapy gross tumor.
~The general dose had been guided that 30-36Gy in 15~18 fractions of 2 Gy 5 days per week was managed for patients with complete response (CR) after chemotherapy and 40-50Gy in 15~18 fractions of 2 Gy 5 days per week for partial response (PR)."
16060791|NCT02449265|Drug|cyclophosphamide|Patients in both arms will be given cyclophpsphamide chemotherapy.
16060792|NCT02449265|Drug|doxorubicin|Patients in both arms will be given doxorubicin chemotherapy.
16060793|NCT02449265|Drug|vincristine|Patients in both arms will be given vincristine chemotherapy.
16060794|NCT02449265|Drug|prednisone|Patients in both arms will be given prednisone chemotherapy.
16060795|NCT02449252|Radiation|Consolidation involved-site radiotherapy (ISRT)|"six cycles modern CHOP chemotherapy. Involved-site radiotherapy (ISRT) is based on defining the site of gross disease before chemotherapy, the GTV and using a CT-based volume with an expansion to form a CTV in the cranio-caudal direction.
~Involved-site radiotherapy (ISRT) is given in 24Gy~30Gy in 12~15 fractions of 2 Gy 5 days per week."
16060848|NCT02448849|Biological|Percutaneous injection|percutanous implantation of bone marrow derived mesenchymal stromal cells in patients with nonunion fracture.
16060796|NCT02449252|Radiation|Consolidation involved-field radiotherapy (IFRT)|"six cycles modern CHOP chemotherapy. Radiotherapy field of involved-field radiotherapy defined by CALGB is encompassed the prechemotherapy gross tumor.
~Involved-field RT (IFRT) is given in 24Gy~30Gy in 12~15 fractions of 2 Gy 5 days per week."
16060797|NCT02449252|Drug|cyclophosphamide|patients in both arms will be given cyclophosphamide chemotherapy.
16060798|NCT02449252|Drug|doxorubicin|patients in both arms will be given cyclophosphamide chemotherapy.
16060799|NCT02449252|Drug|vincristine|patients in both arms will be given cyclophosphamide chemotherapy.
16060800|NCT02449252|Drug|prednisone|patients in both arms will be given cyclophosphamide chemotherapy.
16060801|NCT02449239|Biological|Vicinium|Intravesical administration
16060802|NCT02449200|Other|Multimodal physiotherapy|Manual therapy, exercise and neural unloading tape provided twice weekly over 4 weeks by an experienced musculoskeletal physiotherapist
16060803|NCT02449187|Drug|JLP-1310, Fasted followed by fed|"In period 1, the subjects will receive an oral pill of JLP-1310 under fasted condition.
~In period 2, the subjects will receive an oral pill of JLP-1310 under fed condition."
16060804|NCT02449187|Drug|JLP-1310, Fed followed by fasted|"In period 1, the subjects will receive an oral pill of JLP-1310 under fed condition.
~In period 2, the subjects will receive an oral pill of JLP-1310 under fasted condition."
16060805|NCT02449174|Biological|Frozen Microbiota|Frozen Microbiota will be delivered via enema route.
16060806|NCT02449174|Biological|Lyophilized Microbiota|Lyophilized Microbiota will be delivered orally.
16060807|NCT02449161|Drug|MPA|
16060808|NCT02449161|Drug|placebo|
16060809|NCT02449148|Other|Calorie Restriction|diet intervention to reduce the risk for obesity associated diseases
16060810|NCT02449135|Procedure|interventional therapy|Pancreatic cancer patients received drug interventional therapy using the digital subtraction angiography（DSA）.
16060811|NCT02449122|Procedure|interventional therapy|Lung cancer patients received drug interventional therapy using the digital subtraction angiography（DSA.）
16060812|NCT02449109|Procedure|interventional therapy|Liver cancer patients received drug interventional therapy using the digital subtraction angiography（DSA）
16060813|NCT02449096|Device|Arthroscope|AORIF - arthroscopically assisted open reduction and internal fixation of acute ankle fractures
16060814|NCT02449096|Other|No arthroscope|ORIF - open reduction and internal fixation of acute ankle fractures
16060815|NCT02449083|Procedure|MRI|MRI
16060816|NCT02449083|Procedure|coronary angiography|coronary angiography
16060817|NCT02449070|Drug|Nicorandil|4 mg iv after randomization, 2 mg ic just before ballooning, 2 mg ic just before stenting
16060818|NCT02449057|Other|JUST|Swift, certain, and proportionate sanctions for violations of terms of community supervision.
16060819|NCT02449044|Drug|Tolvaptan|Once Daily
16060820|NCT02449031|Drug|TOBI Podhaler|
16060821|NCT02449031|Drug|TOBI|tobramycin inhalation solution, USP
16060822|NCT02449031|Drug|Bethkis|tobramycin inhalation solution
16060823|NCT02449031|Drug|Cayston|aztreonam for inhalation solution
16060824|NCT02449018|Drug|QBW251|QBW251 capsule(s) taken orally twice per day
16060825|NCT02449018|Drug|Placebo|Matching placebo capsule(s) taken orally twice per day
16060826|NCT02449005|Biological|BM-MSCs/fibrin glue/collagen fleece|Xeno-free, clinical-grade, autologous alveolar bone marrow mesenchymal stem cells enriched with autologous fibrin glue and loaded into a commercially available collagen fleece.
16060827|NCT02449005|Other|Fibrin glue/collagen fleece|The biocomplex of autologous fibrin glue and collagen fleece devoid of stem cells will fill the osseous defect
16060828|NCT02449005|Procedure|Open flap debridement|Group C will receive minimally invasive surgery employing papilla preservation techniques in addition to retaining the soft tissue wall of the pocket. There will be no use of grafting materials
16060829|NCT02448992|Radiation|hippocampal-sparing WBRT|
16060830|NCT02448979|Procedure|Left thoracotomy|Transthoracic approach is the surgical procedure including the open and minimally invasive thoracotomy.
16060831|NCT02448979|Procedure|Right thoracotomy|Transthoracic approach is the surgical procedure including the open and minimally invasive thoracotomy.
16060832|NCT02448966|Procedure|open esophagectomy|
16060833|NCT02448966|Procedure|Minimally invasive esophagectomy|
16060834|NCT02448953|Procedure|Two-field lymphadenectomy|Thoracic-upper abdominal two-field lymphadenectomy
16060835|NCT02448953|Procedure|Three-field lymphadenectomy|Cervical-thoracic-upper abdominal three-field completely lymphadenectomy
16060836|NCT02448940|Dietary Supplement|Species of Lactobacillus|2 capsule a day Lactofem probiotics containing Species of Lactobacillus
16060837|NCT02448940|Dietary Supplement|lactose|2 capsule a day containing lactose
16060838|NCT02448927|Device|balloon aortic valvuloplasty|
16060839|NCT02448927|Device|Transcatheter Aortic Valve Implantation|
16060840|NCT02448914|Drug|TRIGEL|All patients will receive TRIGEL. Treatment order is determined by randomization.
16060841|NCT02448914|Drug|Duodopa|All patients will receive Duodopa. Treatment order is determined by randomization.
16060842|NCT02448901|Drug|Edoxaban|In vitro study. Various concentrations of Edoxoban added to blood sample and tested
16060843|NCT02448888|Other|Adapted exercise|2 months, 3 times/week
16060844|NCT02448888|Other|General exercise recommendations|2 months, 3 times/week
16060845|NCT02448875|Device|CyPass Micro-Stent|Small tube with a through-lumen designed to redirect aqueous fluid from the front to the back of the eye in order to reduce intraocular pressure. Designed to be permanently implanted in the eye.
16060846|NCT02448875|Device|Viscoelastic|Healon 5 ophthalmic viscoelastic used to increase the size of the aqueous drainage area created by the CyPass Micro-Stent
16060847|NCT02448862|Device|Fentanyl based IV-PCA|We have used a disposable PCA pump (Ambix Anaplus®; E-Wha Fresenius Kabi, Korea or accufuser plus®; Woo Young Medical, Korea) and fentanyl was diluted in 100 mL with saline for 48 hrs PCA infusion. The pump was set as follows: infusion rate as 2 ml/hr, bolus dose as 0.5 ml or 1 ml, lockout time as 15 min. It was decided at the anesthesiologist's option whether the additional analgesic drug (ketorolac or nefopam) and the antiemetic drug (ondansetron, ramosetron or palonosetron) would be added in PCA or not. The anesthesiologist who performed the anesthesia decided the amount of chosen drugs.
16060849|NCT02448849|Other|Percutaneous injection|Percutaneous implantation of placebo in patients with nonunion fracture.
16060850|NCT02448836|Device|dTMS H-coil system:magstim stimulator rapid2,BrainswayH1coil|Patients will undergo 8 sessions of dTMS treatment for two weeks (4 sessions every week).
16060851|NCT02448836|Device|Sham: dTMS H-coil system:magstim stimulator rapid2,BrainswayH1coil|Patients will undergo 8 sessions of Sham dTMS treatment for two weeks (4 sessions every week).
16060852|NCT02448823|Other|Mass media and Stylish Events|"Mass media (MM): Radio broadcasts, dramatized dialogues, interviews with opinion leaders and satisfied clients . Posters.
~Stylish Man/Living Event (SMLEvent) community mobilization/service provision. SMLEvent activities. Messages on how CHP (including behaviors such as sexual risk reduction) can make men and women feel more in control of their lives, less stressed, and more Stylish are interwoven through the mobilization.
~The Stylish Man Van (SMV) accompanies the SMLEvent. The Van includes multimedia and health mobilizers who insert HIV prevention messages, testimonials by satisfied CHP customers and where appropriate their spouses."
16060853|NCT02448823|Other|Mass Media|1. Mass media (MM): Radio broadcasts, dramatized dialogues, interviews with opinion leaders and satisfied clients . Posters.
16060854|NCT02448810|Biological|BAX69 + infusional 5-FU/LV|"Study Part 1: Safety Run-in
~Administered weekly as part of a 4 week treatment cycle
~Intravenous injection"
16060855|NCT02448810|Biological|BAX69 + panitumumab|"Study Part 1: Safety Run-in
~Administered weekly as part of a 4 week treatment cycle
~Intravenous injection"
16060856|NCT02448810|Biological|BAX69 + 5-FU/LV|"Study Part 2: Administered weekly as part of a 4 week treatment cycle
~•Intravenous injection"
16060857|NCT02448810|Biological|BAX69 + panitumumab|"Study Part 2: Administered weekly as part of a 4 week treatment cycle
~•Intravenous injection"
16060858|NCT02448810|Drug|Standard of Care|"Investigator's choice
~Dose according to drug label"
16060859|NCT02448810|Biological|Standard of Care|"Investigator's choice
~Dose according to drug label
~Choice includes panitumumab in KRAS &NRAS wt group only"
16060860|NCT02448797|Drug|Icotinib|125 mg three times daily (375 mg per day) orally for two years.
16060861|NCT02448797|Drug|Chemotherapy|Vinorelbine 25 mg/m^2, intravenously guttae, day 1 and day 8, 21 days/cycle, 4 cycles, cisplatin 75 mg/m^2, intravenously guttae, day 1, 21 days/cycle, 4 cycles. For adenocarcinoma: pemetrexed (500 mg/m^2, day 1)/cisplatin (75 mg/m^2, day 1) for 4 cycles.
16060862|NCT02448784|Drug|Donepezil Hydrochloride|Initial dose for oral use is 3 mg once daily. The dose is increased to 5 mg after 1-2 weeks. Following at least 4 weeks of dosing at 5 mg, the dose is increased to 10 mg. The dose may be decreased to 5 mg depending on the symptoms of the participant.
16060863|NCT02448771|Drug|Palbociclib|
16060864|NCT02448771|Drug|Bazedoxifene|
16060865|NCT02448745|Device|Insecticide treated wall lining|Polypropylene non-woven fabric.
16060866|NCT02448732|Drug|ACM-1|intravitreal injection with 50ul ACM-1 at a concentration of 1600ug/ml
16060867|NCT02448719|Drug|TAK-792 30 mg|TAK-792 30 mg was administered in the morning after a fast.
16060868|NCT02448719|Drug|TAK-792 30 mg placebo|TAK-792 30 mg placebo was administered in the morning after a fast.
16060869|NCT02448719|Drug|TAK-792 100 mg|TAK-792 100 mg was administered in the morning after a fast.
16060870|NCT02448719|Drug|TAK-792 100 mg placebo|TAK-792 100 mg placebo was administered in the morning after a fast.
16060871|NCT02448719|Drug|TAK-792 250 mg|TAK-792 250 mg was administered in the morning after a fast.
16060872|NCT02448719|Drug|TAK-792 250 mg placebo|TAK-792 250 mg placebo was administered in the morning after a fast.
16060873|NCT02448719|Drug|TAK-792 500 mg|TAK-792 500 mg was administered in the morning after a fast or after breakfast.
16060874|NCT02448719|Drug|TAK-792 500 mg placebo|TAK-792 500 mg placebo was administered in the morning after a fast or after breakfast.
16060875|NCT02448719|Drug|TAK-792 750 mg|TAK-792 750 mg was administered in the morning after a fast.
16060876|NCT02448719|Drug|TAK-792 750 mg placebo|TAK-792 750 mg placebo was administered in the morning after a fast.
16060877|NCT02448719|Drug|TAK-792 1250 mg|TAK-792 1250 mg was administered in the morning after a fast.
16060878|NCT02448719|Drug|TAK-792 1250 mg placebo|TAK-792 1250 mg placebo was administered in the morning after a fast.
16060879|NCT02448706|Device|Hearing Aid Fitting A|
16060880|NCT02448706|Device|Hearing Aid Fitting B|
16060881|NCT02448693|Device|WLE|Evaluation of the polypectomy scar with High Definition White Light Endoscopy (WLE)
16060882|NCT02448693|Device|NBI|Evaluation of the polypectomy scar with Narrow Band Imaging (NBI, Evis Exera III, Olympus).
16060883|NCT02448680|Biological|Coagulation FVIIa (Recombinant)|A cross over design to assess the efficacy of 2 separate dose regimens (75 µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII or Factor IX
16060884|NCT02448667|Dietary Supplement|FAXE Kondi|Sucrose and glucose containing softdrink
16060885|NCT02448667|Dietary Supplement|Faxe Kondi Free|Diet softdrink with artificial sweeteners aspartame and acesulfame potassium. Both sweeteners are approved for use as food additives in the European Union and by the FDA. Aspartame metabolism is well understood and normal doses does not affect plasma concentrations of lipids, amino acids, glucose levels, key regulatory hormones or skeletal muscle metabolism. Acesulfame Potassium is not metabolized in humans and is excreted as the parent compound in urine. Since the two artificial sweeteners does not affect skeletal muscle metabolism or blood glucose levels, and both compounds have a well documented safety profiles, FAXE Kondi Free is considered to be an ideal placebo soft drink in this study.
16060886|NCT02448654|Drug|Tolcapone|Tolcapone will be compared to sugar pill
16060887|NCT02448654|Drug|Sugar Pill|The sugar pill (placebo) will be compared to tolcapone
16060888|NCT02448641|Biological|SB623 Implant (2.5M)|2.5 million SB623 cells
16060889|NCT02448641|Biological|SB623 Implant (5.0M)|5 million SB623 cells
16060890|NCT02448641|Procedure|Sham surgery|
16060891|NCT02448628|Drug|CS-3150|
16060892|NCT02448602|Other|acupuncture|Patients will be treated with Shenmen(HT7), needle 1 times a day, 30 min/time, 5 days for a period of treatment, the treatment interval for two days, five intervention treatment, follow-up after 4 weeks.
16060973|NCT02448082|Other|Sodium shale oil sulponate 1% shampoo|Shampoo containing the active ingredient of sodium shale oil sulponate 1%.
16063305|NCT02430636|Device|NanoKnife|
16060893|NCT02448602|Other|acupuncture|Patients in Sancai coordinated points group, will be treated with Baihui(DU20), Shenmen(HT7), Sanyinjiao(SP6), needle 1 times a day, 30 min/time, 5 days for a period of treatment, the treatment interval for two days, five intervention treatment, follow-up after 4 weeks.
16060894|NCT02448602|Other|acupuncture|Patients in Control group, will be treated with at the junction of deltoid and biceps, needle 1 times a day, 30 min/time, 5 days for a period of treatment, the treatment interval for two days, five intervention treatment, follow-up after 4 weeks.
16060895|NCT02448589|Drug|TAS-119|
16060896|NCT02448576|Radiation|prophylactic cranial irradiation|Prophylactic cranial irradiation in patients with advanced triple negative breast cancer who had a response to first line chemotherapy
16060897|NCT02448563|Behavioral|Nutrition and physical activity education|Eight weekly in-person groups
16060898|NCT02448550|Drug|Bivalirudin|
16060899|NCT02448550|Drug|Unfractionated heparin|
16060900|NCT02448537|Drug|PM01183|
16060901|NCT02448537|Drug|Doxorubicin|
16060902|NCT02448537|Drug|Gemcitabine|
16060903|NCT02448524|Device|MiStent|Primary in situ coronary artery disease patients (all patients enrolled with a maximum of two target lesions in different blood vessels and maximum of 2 stents per lesion. Lesions with reference diameter of 2.5mm-3.5mm (by visual measurement) and with length ≤40mm (by visual measurement).
16060904|NCT02448524|Device|TIVOLI|Primary in situ coronary artery disease patients (all patients enrolled with a maximum of two target lesions in different blood vessels and maximum of 2 stents per lesion. Lesions with reference diameter of 2.5mm-3.5mm (by visual measurement) and with length ≤40mm (by visual measurement).
16060905|NCT02448511|Other|Ozone|ozone gas generated by a generator applied to the affected part for a period of one hour each day under sub atmospheric pressure condition.
16060906|NCT02448511|Device|Placebo|a similar looking device was applied to the affected part for a period of one hour each day under sub atmospheric condition. the device did not produce any gas.
16060907|NCT02448511|Other|Conventional treatment|Conventional treatment for ulcers in the form of daily dressings, debridement and antibiotics was administered to both groups
16060908|NCT02448498|Behavioral|Exercise Intervention|
16060910|NCT02448472|Other|Observational study, none intervention|
16060911|NCT02448459|Drug|COOL-COS|"Controlled ovarian stimulation will start on the second or third day of a menstrual cycle: Oral clomiphene citrate: 100 mg/day until the day of the triggering. Oral letrozole: 7.5 mg/day during the first 5 days of the controlled ovarian stimulation.
~Corifollitropin Alfa: 100 mcg on the 3rd day of the controlled ovarian stimulation.
~The triggering will be performed using leuprorelin 1 mg (subcutaneous)."
16060912|NCT02448446|Drug|ranibizumab 0.3mg|intravitreally administered
16060913|NCT02448433|Device|Phototherapy light-emitting glasses|"The intervention consists of four weeks of bright light exposure with light-emitting glasses (blue-green 500 nm dominant wavelength; 506 Lux lm/m^2) upon awakening and progressive shift to earlier wake-up times.
~Participants are encouraged to complete the light exposure sessions for 60 min each day. Participants are also instructed to progressively shift their schedule 15 min earlier every day. This shift continues until the end of the four weeks of the intervention, or stops if the target wake-up time of 7:30am is reached (in which case, participants keep a stable wake-up and light session schedule at 7.30am for the remainder of the intervention). If participants already wake-up before 7.30am at study entry, they do the light exposure sessions upon awakening across the four weeks of the intervention.
~During the intervention, participants are asked to note down the time of each light exposure session in a diary. Adherence is also monitored and promoted through weekly phone calls."
16060914|NCT02448420|Drug|Palbociclib|"Cohort A, B1 y B2: Palbociclib oral dose of 200 mg/day for 2 weeks, followed by 1 week off.
~Cohort C1: Palbociclib oral dose 125 mg/d for 3 weeks, followed by one week off, in 4-week cycles."
16060915|NCT02448420|Drug|Trastuzumab|Loading dose of 8mg/kg intravenous (iv) followed by 6 mg/kg once every 3 weeks; or subcutaneous trastuzumab 600mg every 3 weeks.
16060916|NCT02448420|Drug|Endocrine therapy|Non-steroidal AIs (anastrozole, letrozole); steroidal AI (exemestane); Fulvestrant or Tamoxifen
16060917|NCT02448420|Drug|Chemotherapy|Gemcitabine, vinorelbine, capecitabine, eribulin or a taxane
16060918|NCT02448420|Drug|Antibody-Drug Conjugates|3.6 mg/kg iv every 3 weeks
16060919|NCT02448407|Biological|Platelet rich plasma|Three intraarticular injections of platelet-rich plasma, one each fifteen days
16060920|NCT02448407|Drug|Hyaluronic acid|Infiltrations of Hyaluronic acid as Hyaluronate 2,5 ml, 1% solution, administered by intraarticular injections (three doses, one each fifteen days)
16060921|NCT02448394|Other|Community Support Worker|At each of the intervention sites, all newly enrolled participants will have an HIV community support worker (CSW) assigned them. CSW responsibilities include: education on HIV treatment and health promoting behaviors, social support/counseling, facilitated communication with the HIV clinic, referrals as needed for other support needs.
16060922|NCT02448381|Drug|SGX301 (synthetic hypericin)|0.25% SGX301 in USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm^2 fluorescent light.
16060923|NCT02448381|Drug|Placebo|USP Hydrophilic Ointment applied twice per week, covered by opaque bandage for 12-24 hours, then treated with an initial dose of 5 J/cm^2 fluorescent light.
16060924|NCT02448368|Drug|RDEA3170,10 mg|Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.
16060925|NCT02448368|Drug|RDEA3170, 2.5 mg|Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.
16060926|NCT02448368|Drug|RDEA3170, 5 mg|Approximately 20 subjects will be randomized to 1 of 10 treatment sequences with single doses occurring on Days 1, 5, 9, 13, and 17.
16060927|NCT02448368|Drug|RDEA3170, 10 mg|Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.
16060928|NCT02448368|Drug|RDEA3170, 2.5 mg|Fifteen subjects were randomized to 1 of 3 treatment sequences with single doses occurring on Days 1, 5, and 9.
16060929|NCT02448355|Device|OCT swept source DRI-Atlantis, Topcon|3-dimensional scanning protocol with 3 μm axial resolution and a speed of 100,000 A-scans per second. 256 B-scans to be taken on an area of 12 × 9 μm.
16060930|NCT02448342|Device|Remote Dielectric Sensing (ReDS) Wearable System|The ReDS device provides noninvasive measurement of lung fluid content. It comprises a wearable vest with embedded sensors and a bedside console, with touch-screen display. A measurement reading is provided within 90sec. Results are shared with the treating physician via a secured web portal.
16060931|NCT02448329|Drug|AZD1775|AZD1775 225 mg BID q 12 hours (x5 doses, 2.5 days) administered days 1~3
16060932|NCT02448329|Drug|paclitaxel|paclitaxel 80 mg/m2 given days 1, 8 and 15 of a 28 day cycle
16060933|NCT02448316|Procedure|endoscopic surgery|"Through 2 portals profound for the fascia plantaris (deep-fascial) lateral and medial a heel-spur will be resected and the medial half of the fascia is released from its attachment to the calcaneus.
~A mikroskopic X-ray sensitive pearle (Tantalum-pearle) will be inserted in the fascia in the proximal end of the distal part of the remaining fascia for measuring distance (resorbtion).
~Three weeks after operation, the patients are instructed to start a specific training program. Training is supervised every third week by a physiotherapist (week 3,6,9,12 after operation), and daily training is carried out at home. Sutures are removed after 10 days,"
16060934|NCT02448316|Drug|methylprednisolon|1ml methylprednisolon is mixed with 1ml of Lidocain and injected underneath the plantar fascia as close to the medial attachment on calcaneus as possible
16060935|NCT02448316|Drug|lidokaine|1ml methylprednisolon is mixed with 1ml of Lidocain and injected underneath the plantar fascia as close to the medial attachment on calcaneus as possible
16060936|NCT02448316|Behavioral|Training|the patient is instructed in reduction in impact. strength training 3 times weekly and stretching exercises daily are recommended.
16060937|NCT02448303|Drug|Pembrolizumab|
16060938|NCT02448303|Drug|Acalabrutinib|
16060939|NCT02448290|Drug|docetaxel plus selumetinib|Selumetinib will be administered orally 75mg twice a day continuously. Docetaxel will be administered as an IV infusion over 1 hour at 60 mg/m2 every 3 week of a 21 days schedule.
16060940|NCT02448277|Device|Macintosh Laryngoscope|the device is to assist nasotracheal intubation
16060941|NCT02448277|Device|Pentax Airway scope|the device is to assist the nasotracheal tube into trachea
16060942|NCT02448277|Device|Glidescope|the device is to assist the nasotracheal tube into trachea
16060943|NCT02448264|Drug|BCX7353|
16060944|NCT02448264|Drug|Placebo to match BCX7353|
16060945|NCT02448251|Drug|AC0010MA|Following Phase I, a protocol amendment will be submitted to the IND to specify the selected dose and dose justification to be used in Phase II.
16060946|NCT02448238|Other|VSL#3® probiotic|"Other: VSL#3® probiotic VSL#3® DS (Sigma-Tau Pharmaceuticals) is a well characterized water soluble, live (9 × 1011 bacteria/sachet), lyophilized preparation of 8 probiotic bacterium that have been detailed previously. Subjects will take 1 sachet of powder orally daily for 12 weeks. As many Malian homes lack refrigeration, subjects will be issued a special canari, a commonly used earthenware water container also containing sand that works on the principal of trans-evaporation to keep contents at room temperature (~24°C) even in warmer climates. We have verified this in country. Probiotics will be placed in a sealed plastic bag within a sealed jar in the sand of the canari. At the research site, probiotics will be kept refrigerated (4-8°C) in a study provided refrigerator"
16060947|NCT02448225|Procedure|Computed Tomography|Undergo 18F-FDG PET/CT - standard of care
16060948|NCT02448225|Procedure|Computed Tomography|Undergo 18F-FSPG PET/CT
16060949|NCT02448225|Radiation|fluorodeoxyglucose F-18|Undergo 18F-FDG PET/CT - standard of care
16060950|NCT02448225|Drug|Fluorine F 18 L-glutamate Derivative BAY94-9392|Undergo 18F-FSPG PET/CT
16060951|NCT02448225|Other|Laboratory Biomarker Analysis|Correlative studies
16060952|NCT02448225|Procedure|Positron Emission Tomography|Undergo 18F-FDG PET/CT - standard of care
16060953|NCT02448225|Procedure|Positron Emission Tomography (PET)|Undergo 18F-FSPG PET/CT
16060954|NCT02448212|Drug|TS-121|Oral
16060955|NCT02448212|Drug|[11C]TASP0410699|Intravenous radiotracer
16060956|NCT02448212|Radiation|Positron Emission Tomography (PET)|Imaging scanning procedure
16060957|NCT02448199|Drug|Meloxicam and Glucosamine|Experimental
16060958|NCT02448199|Drug|Meloxicam|Active Comparator
16060959|NCT02448199|Drug|Glucosamine|Active Comparator
16060960|NCT02448186|Behavioral|ESTEEM|10-session cognitive behavioral treatment
16060961|NCT02448173|Biological|OncoVAX and Surgery|OncoVAX is comprised of sterile, live but non-dividing tumor cells obtained following standard-of-care surgical tumor resection for Stage II colon cancer
16060962|NCT02448173|Procedure|Surgery|Surgical resection of Stage II colon cancer
16060963|NCT02448160|Device|alfapump|Implantation of alfapump
16060964|NCT02448160|Drug|salt-poor Human Albumin solution|Patients implanted with an alfapump will receive intermittent salt-poor human albumin solution
16060965|NCT02448147|Behavioral|Interval training|Patients will be submitted to three months aerobic exercise training, three times per week. Each session will have two levels of intensity: one minute at respiratory compensation point heart rate intercalating with two minutes at anaerobic threshold heart rate during thirty minutes.
16060966|NCT02448147|Behavioral|Continuous training|Patients will be submitted to three months aerobic exercise training, three times per week. Each session will have only one level of intensity during stimulus phase of exercise, lasting thirty minutes: heart rate (HR) target is defined as 1/3x(HR at respiratory compensation point) + 2/3x(HR anaerobic threshold)
16060967|NCT02448134|Behavioral|Youth Access|Community youth will participate in various school-and-community-wide pro-social, anti-alcohol activities.
16060968|NCT02448121|Procedure|Autologous bone marrow stem cell graft|All patients will undergo autologous bone marrow stem cell implantation into the necrotic lesion area using a minimally invasive technique.
16060969|NCT02448108|Behavioral|i-IPSRT|"internet IPSRT (a form of psychotherapy for individuals with bipolar disorder) will be offered via 12 specially-designed modules.
~CH will have participated in a two day training about Bipolar Disorder and IPSRT."
16060970|NCT02448108|Other|Written Psychoeducation|Written material about the importance of social rhythm regularity to mood stability in bipolar disorder
16060971|NCT02448095|Drug|Ponatinib|Observation of tolerability and safety profiles
16060972|NCT02448082|Other|Shampoo (inactive)|Shampoo which is made to look and feel the same as the experimental shampoo but does not contain the active ingredient of sodium shale oil sulponate 1%.
16060974|NCT02448069|Drug|Argatroban|All patients will receive a 3.0 mcg/kg/min continuous infusion of Argatroban, preceded by a 100 mcg/kg bolus. Infusion will be titrated to achieve an aPTT of 2.25 times baseline (not to exceed 10 mcg/kg/min) for a maximum of 12 hours.
16060975|NCT02448043|Drug|Bimatoprost 0.01%|Bimatoprost drops added to the proximal nail folds of the randomized study hand digits two times per day for 30 days
16060976|NCT02448043|Other|Placebo: saline|Placebo drops added to the proximal nail folds of the hand digits opposite the study hand two times per day for 30 days
16060977|NCT02448030|Other|Functional electric stimulation|The FES will be placed at the flexor muscles of the forearm and knee extensors, for evaluation of upper and lower limbs, respectively. The stimulation frequency will be 20 Hz. The pulse width used will be 0.5 milliseconds and the contraction time will be 60 seconds (TON: 60s) with a 1-second rest interval (TOFF: 1s). The total time of application will be determined for the muscle fatigue that will be evaluated by 10-point Borg scale and by the measurement of lactate accumulation that must not exceed 30 minutes. The intensity will be adjusted individually, taking into account the patient's ability to promote the full flexion of the wrist / knee extension and comfort during contractions. Along with the application of FES a 1 Kg overload will be applied to intensify the fatigue time.
16060978|NCT02448030|Other|Isometric exercise|For the upper limbs the isometric contraction exercise with handgrip will be performed for 5 minutes with 30% of loading, previously measured by maximum voluntary contraction test. For the lower limbs the knee extension exercise will be conducted in a training station. The SBP, DBP, MBP and HR will be recorded through the protocols. Fatigue will be determined every minute by the 10-point Borg scale and by measurement of lactate accumulation before, immediately after the protocol, and 5 minutes during the recovery period.
16060979|NCT02448017|Device|The Herbst appliance|Orthodontic functional appliance
16060980|NCT02448017|Device|Twin block appliance|Orthodontic functional appliance
16060981|NCT02448004|Drug|JNJ-63623872|Participants will receive a single 600-mg dose of JNJ-63623872 administered as three capsules containing 14C-labeled and unlabeled JNJ-63623872.
16060982|NCT02447991|Drug|Rizatriptan|During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of this study.
16060983|NCT02447991|Drug|Placebo|During the study either placebo or Rizatriptan will be given to subjects to take during the treatment phase of the study.
16060984|NCT02447978|Biological|Infanrix|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed Indicated as a 5-dose series in infants and children 6 weeks to 7 years of age.
16060985|NCT02447978|Biological|Pediarix|Diphtheria and Tetanus Toxoids and Acellular Pertussis Ad-sorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Indicated as a 3-dose series in infants born of hepatitis B surface antigen (HBsAg)-negative mothers. PEDIARIX may be given as early as 6 weeks of age through 6 years of age (prior to the 7th birthday).
16060986|NCT02447978|Biological|Kinrix|Diphtheria and Tetanus Toxoids and Acellular Pertussis Ad-sorbed and Inactivated Poliovirus Vaccine
16060987|NCT02447965|Drug|Bupivacaine|Using ultrasound guidance bupivacaine will be injected into the active group's rectus abdominis sheath.
16060988|NCT02447965|Drug|Normal Saline|Using ultrasound guidance normal saline will be injected into the placebo group's rectus abdominis sheath.
16060989|NCT02447952|Device|Faros Sensor (FS) and LifeInsight Hub|Each subject will be issued one FS and a MAT LifeInsight Hub for use during the study. At each clinic visit in the Pilot and Core Study Phases, the Faros sensor will be placed on the subject just prior to the defined reference tasks and will be worn on the subject's sternum during completion of the tasks. The morning after the clinic visit, the subject will re-attach the sensor and wear it for approximately 3 days. In between visits during the Core Study Phase the subject will wear the FS every month for approximately 3 days to enable data collection on a monthly basis over the 48 week study period. Movement/physical activity data will be collected by the FS throughout the study.
16060990|NCT02447952|Device|Fast Fix electrode patch|The Fast Fix electrode patch will be worn with the FS on the subject's sternum according to the same schedule as the FS. The Fast Fix electrode patch will be replaced by the subject on a daily basis during the 3 day monitoring period. Subjects will be provided instructions on how to operate and wear the Fast Fix electrode patch.
16060991|NCT02447952|Procedure|Quantitative Measure of Speech (Core Phase Only)|Subjects will follow simple prompts on a computer screen instructing them to say a series of vowels, words, and paragraphs which will be recorded using a high definition digital microphone and stored securely on a laptop. The speech waveform data will be sent via secure method to GSK/MAT for processing.
16060992|NCT02447939|Drug|Dabrafenib|Dabrafenib will be provided as 50 mg and 75 mg capsules. Each capsule will contain 50 mg or 75 mg of free base (present as the mesylate salt).
16060993|NCT02447939|Drug|Trametinib|Trametinib study will be provided as 0.5 mg and 2.0 mg tablets. Each tablet will contain 0.5 mg or 2.0 mg of trametinib parent (present as the DMSO solvate)
16060994|NCT02447926|Procedure|Leukapheresis|"Catheter placement will occur for about 1 hour. The research nurse will schedule leukapheresis on the next day following catheter placement.
~On the day of leukapheresis, a blood draw will monitor blood counts, kidney function, liver function, and blood clotting ability. Vital signs will be checked three times over the course of intervention.
~During the procedure, blood is mixed with anticoagulant and separated (i.e. red blood cells, white blood cells, platelets, and plasma). 1-1.5 cups of white blood cells will be collected. Leukapheresis will last 3-6 hours.
~Remaining components, except for 100-200 ml of plasma, are returned through the catheter. Two teaspoons of blood will be drawn to determine when catheter removal can occur. This part of intervention lasts about 2.5-4 hours."
16060995|NCT02447913|Behavioral|Voucher|"Introduction of vouchers will improve uptake of family method as well as child immunization.
~Incentivizing the providers to improve their counseling skills will improve the provider client relationship and better compliance of Family planning method"
16060996|NCT02447900|Device|BioXmark|
16060997|NCT02447887|Drug|Ixazomib|The prescribed administration of ixazomib doses in this study is 1.5-4.0 mg ixazomib weekly for 3 out of 4 weeks in each cycle (1 cycle=28 days).
16060998|NCT02447887|Drug|Pegylated IFN-alpha 2b|Weekly injection
16060999|NCT02447874|Drug|Arginine|"Arginine will be dispensed intravenously (in the vein) in the standard dose of arginine as 100 mg/kg three times a day for seven days or until discharge.
~Loading dose: 200 mg/kg once
~Continuous IV: 300 mg/kg/24 hours"
16061000|NCT02447874|Drug|Arginine (Loading)|Arginine will be dispensed intravenously (in the vein) as an initial bolus (loading) arginine dose at 200 mg/kg once
16061001|NCT02447874|Drug|Arginine (Continuous)|Arginine will be dispensed intravenously (in the vein) as a continuous IV infusion of 300 mg/kg/24hr
16061002|NCT02447848|Drug|sufentanil sublingual 30 mcg tablet|
16061003|NCT02447835|Drug|Olanzapine|Olanzapine is approved for the treatment of schizophrenia and mania associated with bipolar disorder. Olanzapine is a psychotropic agent that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-4methyl-1 piperazinyl-10H-thienol (2,3-b)[1,5]benzodiazepine. The molecular formula is C17H20N4S which corresponds to a molecular weight of 312.44.Olanzpine is a yellow crystalline solid which is practically insoluble in water. Olanzapine is a selective monoaminergic antagonist with high affinity binding to the following receptors:5HT2A2C, 5HT6, dopamine 2-4, histamine H1, and adrenergic α-1. In addition olanzapine is an antagonist with moderate affinity for muscarinic M1-5 and 5HT3. The mechanism of action of olanzapine is unknown although it may be mediated through a combination of dopamine and serotonergic type 2 receptors.
16061004|NCT02447822|Drug|Thymoglobulin|6.0 mg/kg vs 4.5 mg/kg Thymoglobulin
16061005|NCT02447809|Drug|Clopidogrel|(ASA 100mg daily and Clopidogre 75mg daily)* 12 month.
16061006|NCT02447809|Drug|acetylsalicylic acid (ASA)|
16061007|NCT02447796|Drug|Propofol|Propofol was administered at 1 mg/kg over a 10-min period followed by a continuous infusion at a rate of 1-1.5 mg/kg/h until the the begining of skin suture (n=24).
16061008|NCT02447796|Drug|Dexmedetomidine|DEX was administered at 1 μg/kg over a 10-min period followed by a continuous infusion at a rate of 1-1.5 μg/kg/h until the begining of skin suture (n=24).
16061009|NCT02447783|Dietary Supplement|Control Capsules|Cocoa-based, flavanol-free, control-matched capsules consumed for 12 weeks (Week 1: 2 capsules/day; Week 2: 3 capsules/day; Week 3-12: 4 capsules/day; Week 12-14: no capsule intake).
16061010|NCT02447783|Dietary Supplement|Mars Cocoa Extract Capsules|Capsules containing Mars Cocoa Extract manufactured by the Cocoapro® process and containing 500 mg of cocoa flavanols per capsule consumed for 12 weeks (Week 1: 2 capsules/day; Week 2: 3 capsules/day; Week 3-12: 4 capsules/day; Week 12-14: no capsule intake).
16061011|NCT02447770|Dietary Supplement|Mars Cocoa Extract Capsules|Capsules containing Mars Cocoa Extract manufactured by the Cocoapro® process, providing 500 mg of cocoa flavanols per capsule: 1000 mg of cocoa flavanols consumed daily during week 1 and 2, 1500 mg of cocoa flavanols consumed daily during week 3 and 4, and 2000 mg of cocoa flavanols consumed daily during week 5 and 6, and no capsule consumed (washout) during week 7 and 8.
16061012|NCT02447757|Drug|remifentanil|Remifentanil analgesia during delivery
16061013|NCT02447744|Behavioral|Mindfulness based intervention|The intervention is an 8-week structured mindfulness based behavioral intervention program that teaches mindfulness meditation, mindful yoga and psychological knowledge about stress.
16061014|NCT02447731|Device|"Induction of sound waves in lungs by sonic oscillator"|A device called sonic oscillator will add sonic waves to the inhaled gases while the subjects are going through 3 tests measuring the variations made in pulmonary functions induced by sound waves.
16061015|NCT02447718|Biological|Prevnar®13|A single dose of Prevnar®13 will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.
16061016|NCT02447718|Biological|Pneumovax® 23|A single dose of Pneumovax® 23 will be administered to subjects approximately 2 months after Prevnar®13
16061017|NCT02447718|Biological|Pediacel®|A single dose of Pediacel® will be administered to subjects with ALL who are 6-12 months post-completion of chemotherapy.
16061018|NCT02447705|Drug|telbivudine|telbivudine replace Lamivudine
16061021|NCT02447679|Drug|thalidomine|thalidomine (400mg/day) for 1 year to prevent HCC recurrence
16061022|NCT02447679|Drug|tegafur-uracil|tegafur-uracil (2 tablelet twice a day) for 1 year to prevent HCC recurrence
16061023|NCT02447666|Drug|Azacitidine|
16061024|NCT02447653|Device|G7 HA Acetabular Component|G7 HA Acetabular Component
16061025|NCT02447653|Device|G7 PPS Acetabular Component|G7 PPS Acetabular Component
16061026|NCT02447640|Drug|ADX48621|ADX4862, an investigational compound, is a potent, selective, negative allosteric modulator of the metabotropic glutamate receptor 5 (mGlu5 NAM).
16061027|NCT02447640|Radiation|[18F]FPEB|radiotracer used for PET scanning
16061028|NCT02447614|Procedure|Adenotonsillectomy|Adenotonsillectomy
16061029|NCT02447614|Other|Conservative treatment|Mometasone Furoate Aqueous Nasal Spray or uticasone propionate (1/once qd) and（or）Leukotriene antagonists(4 or 5mg/once qn) or H1 receptor antagonists
16061030|NCT02447614|Other|no treatment|just regular follow-up
16061031|NCT02447601|Drug|PEX168|200µg,injected subcutaneously,once a week.
16061032|NCT02447601|Drug|Simvastatin|40mg,oral,two times
16061033|NCT02447588|Other|IAD at 36 hours|Intrauterine insemination with sperm donor at 36 hours post-hCG
16061034|NCT02447588|Other|IAD at 24 hours|Intrauterine insemination with sperm donor at 24 hours post-hCG
16061035|NCT02447575|Other|Education on Use of MDI|After the subject demonstrated the use of MDI with the electronic flowmeter in place, the intervention was provided- a short verbal education to demonstrate the correct use of MDI.
16061036|NCT02447562|Device|Platform NOMHADchronic|Intervention group with a health Platform NOMHADchronic
16061037|NCT02447562|Other|Phone-based care group|
16061038|NCT02447562|Other|Usual care group|
16061039|NCT02447549|Radiation|WBRT|One RT plan with whole bladder treated to standard dose.
16061040|NCT02447549|Radiation|SART|Three plans (small, medium & large) generated with the standard dose of RT focused on the tumour, sparing the normal bladder from full dose radiation. Pretreatment cone beam CTs will be used to select the best fitting of the three plans prior to treatment.
16061041|NCT02447549|Radiation|DART|Three plans (small, medium & large) generated with a higher dose than standard focused on the tumour and the remainder of the bladder treated to the same dose as in the SART group. Pretreatment cone beam CTs will be used to select the best fitting of the three plans prior to treatment.
16061042|NCT02447536|Biological|BCG-Denmark 1331 (Statens Serum Institute)|See above
16061043|NCT02447536|Biological|BCG-Russia-I (Serum Institute of India)|See above
16061044|NCT02447523|Procedure|Elective abdominal surgery|
16061045|NCT02447510|Procedure|group 1 bio-oss bone xenograft|bone substitute (bio-oss)
16061046|NCT02447510|Procedure|group 2 platelet rich in growth factor (autogenous platelet rich in growth factor)|platelet rich in growth factor (autogenous platelet rich in growth factor)
16061047|NCT02447510|Procedure|group 3 platelet rich fibrin (autogenous platelet rich fibrin)|platelet rich fibrin (autogenous platelet rich fibrin)
16061048|NCT02447497|Drug|3M CHG/IPA Surgical Skin Preparation - Abdominal Region|Chlorhexidine gluconate 2% / Isopropyl alcohol 70%
16061049|NCT02447497|Other|Normal Saline - Abdominal Region|0.9% sodium chloride applied with foam applicator
16061050|NCT02447497|Drug|3M CHG/IPA Surgical Skin Preparation - Inguinal Region|Chlorhexidine gluconate 2% / Isopropyl alcohol 70%
16061051|NCT02447497|Other|Normal Saline - Inguinal Region|0.9% sodium chloride applied with foam applicator
16061052|NCT02447484|Behavioral|Mujer Segura Siempre|Participants receive personalized text messages twice a day, five days per week. Messages are designed to encourage women to maintain positive behavioral changes they have made in response to the baseline safer-sex training that is delivered to all participants regardless of intervention assignment. Message content is based upon theoretical constructs of behavior-change maintenance as articulated by Voils et al. (Health Education & Behavior, 2013). Personalization elements include participant's name, times of day when she prefers to receive messages, and specific motivators of behavior change she expressed in the baseline interview.
16061053|NCT02447484|Behavioral|General Health Message Texts|Participants receive generic health-promotion text messages twice a day, five days per week.
16061054|NCT02447471|Device|Nexfin|Nexfin cuff placed on finger to measure blood pressure
16061055|NCT02447458|Drug|MLN3126|MLN3126 tablets
16061056|NCT02447458|Drug|MLN3126 Placebo|MLN3126 placebo-matching tablets
16061057|NCT02447445|Procedure|Grip strength assessment|Grip strength will be measured by the ward nurse using a Jamar dynamometer by asking the patient to squeeze with each hand twice, starting with the right hand using the standardised protocol The maximum GS measurement will be recorded. Patients who have low maximum GS values (men < 27 kg and women <16 kg) or those who are unable to perform the test will receive a care plan. The care plan will focus on review of dietary energy and protein intake and any need for oral nutritional supplements or dietetic review, and review of mobility with any need for physiotherapy review with regard to progressive resistance exercises to increase muscle strength.
16061058|NCT02447432|Biological|Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (4-dose presentation)|4 doses by intramuscular injection in the right left anterolateral thigh
16061059|NCT02447432|Biological|Pneumococcal vaccine GSK1024850A (10Pn-PD-DiT) vaccine (1-dose presentation)|4 doses by intramuscular injection in the right anterolateral thigh
16061060|NCT02447432|Biological|DTPw-HBV/Hib|3 doses by intramuscular injection in the left anterolateral thigh
16061061|NCT02447419|Drug|Gefitinib|Gefitinib 250mg will be administered orally daily
16061062|NCT02447406|Drug|AZD6094|
16061063|NCT02447406|Drug|docetaxel|
16061064|NCT02447393|Drug|levocetirizine|levocetirizine
16061065|NCT02447393|Drug|cetirizine|cetiridine
16061066|NCT02447393|Drug|placebo|placebo
16061067|NCT02447380|Drug|AZD6094|AZD6094 600MG qd
16061068|NCT02447380|Drug|Docetaxel|Docetaxel 60 mg/m2
16061069|NCT02447367|Drug|JLP-1207(Fasted)|Fasted followed by fed in period 1, the subjects will receive an oral pill of JLP-1207 under fasted condition.
16061070|NCT02447367|Drug|JLP-1207(Fed)|Fed followed by fasted in period 1, the subjects will receive an oral pill of JLP-1207 under fed condition
16061071|NCT02447328|Drug|Fulvestrant|fulvestrant (Faslodex®) 500mg/month for about 6 months with an additional 500mg dose given 14 days after the initial dose injection.
16061072|NCT02447315|Drug|Pilocarpine|oral
16061073|NCT02447315|Drug|Placebo|oral
16061074|NCT02447302|Drug|Etrasimod|
16061075|NCT02447302|Drug|Placebo|
16061076|NCT02447289|Drug|Intranasal ketamine|Ketamine injectable solution in a concentration of 50.0 mg/mL administered into the nose with an atomizer; dose of 4.0 mg/kg, maximum 100.0 mg
16061077|NCT02447289|Drug|Oral ketamine|Ketamine injectable solution in a concentration of 50.0 mg/mL via oral route; dose of 4.0 mg/kg maximum 100.0 mg
16061078|NCT02447289|Drug|Intranasal midazolam|Midazolam injectable solution in a concentration of 5.0 mg/mL administered into the nose with an atomizer; dose of 0.2 mg/kg, maximum 5.0 mg
16061079|NCT02447289|Drug|Oral midazolam|Midazolam oral solution in a concentration of 2.0 mg/mL via oral route; dose of 0.5 mg/kg, maximum 5.0 mg when associated with ketamine; dose of 1.0 mg/kg, maximum 20.0 mg when give as a solely agent
16061080|NCT02447276|Drug|REGN475|
16061081|NCT02447276|Drug|Placebo|
16061082|NCT02447263|Procedure|interventional therapy|liver cancer patients received HepaSphere interventional therapy using the digital subtraction angiography（DSA）
16061083|NCT02447250|Drug|Varied albuterol dose response|Subjects will be evaluated in 3 sessions. The sessions will occur within a 7 day time span, beginning between 14 or more days from birth and at a corrected gestational age of 28w0d to 33w6d. In each session, pulmonary function tests (PFTs) will be performed prior to and 15 minutes after a dose of albuterol. The dose will be different in each session. In the first session, a sinlge dose of 180 micrograms (2 puffs) of albuterol sulfate via metered dose inhaler. The dose will be 270 micrograms in the second session and 360 micrograms in the third session. PFTs will be performed during quiet sleep while the baby is spontaneously breathing or while the baby is intubated and receiving mechanical ventilation. Resistance and compliance will be measured using the single breath occlusion technique.
16061084|NCT02447237|Other|dietary counselling|the participants will receive dietary counselling in fulfilling their need of energy and protein according to the group they are randomized to (either solid or liquid food).
16061085|NCT02447224|Drug|1 gm IV ertapenem at enrollment|
16061086|NCT02447224|Drug|1 gm IV ertapenem at Day 2 and oral metronidazole and cefdinir to complete 10 days|
16061087|NCT02447224|Procedure|Appendectomy|
16061088|NCT02447211|Drug|Doxepin cream 5%|Patients use doxepin creamtwice daily for one weeks
16061137|NCT02446899|Biological|Anifrolumab|Intravenous infusion (IV)
16061089|NCT02447211|Other|Placebo|Patients use cream without doxepin ingredient twice daily for one weeks
16061090|NCT02447185|Drug|Ranibizumab|"A week before 25-gauge vitrectomy, all subjects in Ranibizumab group will receive Ranibizumab 0.5mg/0.05 ml intravitreal injection.
~All subjects in Ranibizumab group will get Ranibizumab 0.2 mg/0.02 ml intravitreal injection just after the operation."
16061091|NCT02447185|Drug|Triamcinolone Acetonide|"A week before 25-gauge vitrectomy, all subjects in TA group will receive Triamcinolone Acetonide 4mg/0.1ml intravitreal injection.
~During operation all subjects in Ranibizumab group and in TA group will be injected Triamcinolone Acetonide 4 mg/0.1ml.
~All subjects in TA group will get Triamcinolone Acetonide 1mg/0.025 ml intravitreal injection just after the operation."
16061092|NCT02447172|Drug|Gentamicin Collagen sponge|Up to 4 topical Gentamicin Collagen Sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)
16061093|NCT02447172|Other|Placebo|Matching placebo sponge
16061094|NCT02447159|Behavioral|Conditional Cash Transfers|Each participant in the intervention arm will receive conditional cash transfers when she: (1) registers pregnancy, (2)picks up her medication in the first two months after her first visit, (3) delivers at the health clinic, and (4) receives early infant diagnosis test for newborn. Eight to ten weeks after delivery, the participant will also be asked to participate in an endline survey and will be compensated for her time.
16061095|NCT02447146|Other|Resistance Training|The TG performed the RT program using weight machines. Before the training period, participants underwent three weeks with eight familiarization sessions to ensure proper technique execution. The protocol aimed to workout major muscle groups and involved the following exercises: chest press, knee extension, hamstrings curl, leg press, and seated row. Training sessions lasted approximately 50-60 minutes with 2 sets of 10-12 repetitions until fatigue.
16061096|NCT02447146|Other|Lectures on the disease|The control group attended an orientation program with lectures on health, quality of life and scientific update on disease.
16061097|NCT02447133|Device|3D OCT-1 Maestro|OCT Machine used for diagnostic purposes
16061098|NCT02447120|Device|3D OCT-1 Maestro|OCT machines used for diagnostic purposes
16061099|NCT02447107|Other|Electronic Diary|The electronic diary asks subjects questions about their compliance with mobile application usage. The questions contained in this diary ask patients how often their personal mobile device has been on their person, if and how long the applications relevant to the study were turned off, and why patients failed to comply with study requirements.
16061100|NCT02447107|Other|Questionnaire|Study patients will be asked to complete a questionnaire at the 1 and 2-week endpoints. This questionnaire is administered in order to measure patient satisfaction with the mobile applications.
16061101|NCT02447094|Drug|Alteplase|Intravenous (i.v.) tPA per the standard of care
16061102|NCT02447081|Device|Subjects implanted with Amulet Device|Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.
16061103|NCT02447068|Device|Luma Light System|The Luma Light System combines a NBUVB light with an occlusive dressing.
16061104|NCT02447068|Device|Luma Light|NBUVB light
16061105|NCT02447068|Device|Occlusive Dressing|Off-the-shelf occlusive dressing
16061106|NCT02447055|Biological|Tocilizumab|
16061107|NCT02447055|Drug|Melphalan|
16061108|NCT02447055|Drug|Fludarabine|
16061109|NCT02447055|Drug|Cyclophosphamide|
16061110|NCT02447055|Drug|Tacrolimus|
16061111|NCT02447055|Drug|Mycophenolate mofetil|
16061112|NCT02447055|Drug|Filgrastim|
16061113|NCT02447042|Procedure|Fluid challenge with crystalloids|Intravenous infusion of 2, 3, 4 or 5 ml/Kg of crystalloids over 5 minutes.
16061114|NCT02447042|Device|Measurement of Pmsf-arm|Measurement of stop-flow arterial-venous equilibrium pressure in the arm where the radial arterial pressure is measured by inflating a pneumatic cuff with an automatic pneumatic tourniquet during 60 seconds before and after the fluid challenge in patients receiving 2 ml/Kg, 3 ml/kg, 4 ml/kg and 5 ml/kg of crystalloids in 5 minutes
16061115|NCT02447029|Drug|vaginal 2% Xylocaine|patient-administered vaginal lidocaine jelly versus provider-administered standard lidocaine paracervical block
16061116|NCT02447029|Drug|standard lidocaine paracervical block|1% lidocaine paracervical injection
16061117|NCT02447016|Drug|Tenofovir disoproxil/emtricitabine/rilpivirine|
16061118|NCT02447016|Drug|Tenofovir disoproxil/emtricitabine/efavirenz|
16061119|NCT02447003|Biological|Pembrolizumab|IV infusion of 200 mg.
16061120|NCT02446990|Drug|Ivabradine|5 mg, 7.5 mg or 10 mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
16061121|NCT02446990|Drug|Placebo|Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 48 months.
16061122|NCT02446977|Drug|Vitamin B2 Streuli®|4ml IV
16061123|NCT02446977|Other|Solution for injection|4ml IV
16061124|NCT02446964|Procedure|Bone Marrow Transplantation|Undergo bone marrow transplant
16061125|NCT02446964|Drug|Cyclophosphamide|Given IV
16061126|NCT02446964|Drug|Fludarabine Phosphate|Given IV
16061127|NCT02446964|Other|Laboratory Biomarker Analysis|Correlative studies
16061128|NCT02446964|Drug|Mycophenolate Mofetil|Given PO or IV
16061129|NCT02446964|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo peripheral blood stem cell transplant
16061130|NCT02446964|Drug|Tacrolimus|Given IV and PO
16061131|NCT02446964|Radiation|Total Marrow Irradiation|Undergo TMLI
16061132|NCT02446938|Procedure|Esophagus balloon catheter insertion.|Esophagus balloon catheter will be inserted and the position of the balloon will be confirmed by a air injection test.A bolus of 30 ml of air was injected to the gastric lumen of the catheter just next to the distal edge of the balloon, during the onset of end-expiratory phase. The presence of a positive disturbing wave (PDW) in esophageal pressure waveform to this air injection will be the indicator of the right balloon position.
16061133|NCT02446925|Device|Surefire® Infusion System|Utilization of Surefire® Infusion System for Y-90 glass microsphere embolization
16061134|NCT02446925|Device|Standard End-hole catheter|Utilization of Standard End-hole catheter for Y-90 glass microsphere embolization
16061135|NCT02446912|Biological|Anifrolumab|Anifrolumab IV administration every 4 weeks from Week 0 to Week 48 for a total of 13 doses
16061136|NCT02446912|Drug|Placebo|Placebo IV administration every 4 weeks from Week 0 to Week 48
16061139|NCT02446886|Drug|Adrenocorticotropic hormone (ACTH) gel (H.P. Acthar®)|"Adrenocorticotropic hormone (ACTH) gel, a long-acting formulation of the full sequence ACTH that includes other pro-opiomelanocortin (POMC) peptides, is considered an alternative to corticosteroids in the treatment of relapses (currently FDA approved for this indication).
~ACTH (H.P. Acthar®) gel exerts direct anti-inflammatory and immune-modulating effects within the CNS, specifically on infiltrating macrophages and resident microglia as well as protecting mature oligodendrocytes from inflammation-related damage and excitotoxicity. These effects are mediated not only via induction of endogenous corticosteroid production but also via effects on melanocortin receptors."
16061140|NCT02446873|Other|Egg supplementation|A weekly supply of eggs will be given to the mother in the egg supplementation group with instructions to give the child one egg per day.
16061141|NCT02446860|Drug|nivolumab|Nivolumab 3 mg/kg by intravenous infusion, given every two weeks for eight weeks prior to nephrectomy, then post-operatively until patient is no longer deriving clinical benefit.
16061142|NCT02446847|Drug|3BNC117|3BNC117 infusions
16061143|NCT02446847|Other|ART Interruption|Antiretroviral therapy will be discontinued 2 days after the first 3BNC117 infusion (day 2) and resumed at week 12.
16061144|NCT02446834|Behavioral|intensive lifestyle intervention|3 months low GI diet and exercise
16061145|NCT02446834|Drug|GLP-1 Receptor Agonists|Use GLP-1 Receptor Agonists 3 months to treat PCOS
16061146|NCT02446834|Drug|Metformin|Use metformin 3 months to treat PCOS
16061147|NCT02446834|Drug|Acarbose|Use acarbose 3 months to treat PCOS
16061148|NCT02446821|Device|VeraCept|IUD placement of VeraCept
16061149|NCT02446808|Device|Intraoperative nerve monitoring|Intraoperative nerve monitoring (electromyography) is used to identify the location of somatic pelvic nerves critical to urinary continence control and erectile function in real time during robotic-assisted laparoscopic prostatectomy surgery
16061150|NCT02446795|Drug|Sunitinib|Sunitinib: 50mg once daily orally for 4 weeks followed by 2 weeks off treatment (either at 8 a.m. or at 8 p.m.)
16061151|NCT02446795|Drug|Isoquercetin|Isoquercetin: 225mg twice a day(at 08 a.m. and at 4 p.m)/Isoquercetin: 450 mg twice a day(at 08 a.m. and at 4 p.m).
16061152|NCT02446795|Drug|Placebo|Placebo: 225mg twice a day(at 08 a.m. and at 4 p.m)/Placebo: 450 mg twice a day(at 08 a.m. and at 4 p.m).
16061153|NCT02446782|Drug|Cefazolin|Cefazolin 2 gm administered in 100 mL normal saline (after skin sensitivity testing) 15-30 minutes before the start of the procedure. Clindamycin 900 mg to be administered if sensitivity detected to cefazolin.
16061154|NCT02446782|Other|saline|100 mL normal saline 15-30 minutes before the start of the procedure
16061155|NCT02446769|Device|AVAPS-AE Non-invasive ventilation therapy|Participants will use the device greater than or equal to 4hrs per night for the 60 days after discharge.
16061156|NCT02446756|Other|acupuncture|
16061157|NCT02446756|Other|physiotherapy|
16061158|NCT02446743|Biological|rMenB+OMV NZ (Meningococcal (Group B) multi component recombinant adsorbed vaccine)|One dose of the vaccine administered intramuscularly in the deltoid area of the non-dominant arm.
16061159|NCT02446730|Device|BES (biodegradable polymer biolimus-eluting stent)|BES implantation
16061160|NCT02446730|Drug|Prasugel|
16061161|NCT02446730|Drug|Clopidogrel|
16061162|NCT02446717|Drug|ABT-493, ABT-530|ABT-493 (tablet) dosed with ABT-530 (tablet)
16061163|NCT02446717|Drug|ribavirin (RBV)|Tablet
16061164|NCT02446717|Drug|ABT-493/ABT-530|Tablet; ABT-493 coformulated with ABT-530
16061165|NCT02446704|Drug|Olaparib|
16061166|NCT02446704|Drug|Temozolomide|
16061167|NCT02446691|Biological|MenACWY|Four Intramuscular doses of MenACWY vaccine at 2, 4, 6 and 12 months of age followed by two blood samples at 13 and 24 months of age.
16061168|NCT02446678|Device|PillCam ESO2|Capsule endoscopy
16061169|NCT02446665|Device|MR Elastography (MRE) and FibroScan|
16061170|NCT02446652|Drug|Hydralazine/Magnesium|(Hydralazine: 1 oral tablet every 24 hours, 182 mg for rapid acetylators, and 83 mg for low acetylators and Magnesium valproate: orally 30 mg/K weight every 8 hours) starting 1 week prior the first day of the QT
16061171|NCT02446652|Drug|Placebo|Placebo (orally) starting 1 week before the first day of the QT
16061172|NCT02446652|Drug|Carboplatin|5 AUC 1 hour/day 1 for every 21 days for 6 cycles
16061173|NCT02446652|Drug|Paclitaxel|175mg/m2/SC 3hour/day 1 for every 21 days for 6 cycles.
16061174|NCT02446639|Other|Blood collection|
16061178|NCT02446613|Other|Pollen allergen extract|Pollen (tree, grass or ragweed) allergen extracts will be provided by the research unit and diluted as required in normal saline. The specific pollen allergen extract that will be used for the nasal allergen challenge will be selected according to each subject's individual allergic sensitivity demonstrated in the previous study, TL7116958. If possible, extracts remaining from this study in 2014 will be used, provided they have not reached their expiry date.
16061179|NCT02446600|Drug|Carboplatin|Given IV
16061180|NCT02446600|Drug|Cediranib Maleate|Given PO
16061181|NCT02446600|Drug|Gemcitabine|Given IV
16061182|NCT02446600|Drug|Gemcitabine Hydrochloride|Given IV
16061183|NCT02446600|Other|Laboratory Biomarker Analysis|Correlative studies
16061184|NCT02446600|Drug|Olaparib|Given PO
16061185|NCT02446600|Drug|Paclitaxel|Given IV
16061186|NCT02446600|Drug|Pegylated Liposomal Doxorubicin Hydrochloride|Given IV
16061187|NCT02446600|Other|Pharmacological Study|Correlative studies
16061188|NCT02446600|Other|Quality-of-Life Assessment|Ancillary studies
16061189|NCT02446587|Device|Mechanical Thrombectomy|Mechanical thrombectomy includes the use of stent retrievers (i.e. Trevo®, Solitaire®, or other stent retriever devices) as recommended by AHA guidelines (July 2015). A stent retriever is delivered directly to a thromboembolus that is occluding a cerebral artery to restore blood flow.
16061197|NCT02446548|Drug|aliskiren|aliskiren will be administered at a dose of 150 mg, each dose was to be taken orally with water once daily at approximately 8:00 A.M., except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed. Drug compliance will be assessed by tablet counts.
16061198|NCT02446548|Drug|losartan|losartan will be administered at a dose of 50 mg, each dose was to be taken orally with water once daily at approximately 8:00 A.M. except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed. Drug compliance will be assessed by tablet counts.
16061199|NCT02446548|Other|Placebo|placebo will be administered once daily orally (1 tablet) in the morning with water at approximately 8:00 A.M. except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed. Compliance will be assessed by tablet counts. Placebo was prapared in Department of Pharmaceutical Technology MU Gdańsk
16061200|NCT02446535|Other|achievement of the DW by means of the BIA DW (RE.S.T.)|
16061201|NCT02446522|Procedure|Open vein harvesting|Open vein harvesting was performed as a continuous incision under vision control. The GSV was identified two fingers proximal to the medial malleolus according to the standard practice. The vein was harvested using Metzenbaum scissors, and a continuous incision was made along the route of the vein. Care was taken not to traumatize the nerve, vein or its branches. Vein branches were ligated with titanium clips. The wound was closed in layers with continuous 2-0 Polysorb sutures and 3-0 skin sutures.
16061202|NCT02446522|Procedure|Endoscopic vein harvesting|Endoscopic vein harvesting was performed through minimal incisions with use of Vasoview 6 system (Maquet Medical Systems, Wayne, NJ, USA.) The vein was identified through a 3 cm incision below the knee. The incision site was sealed using a balloon port to create a tunnel inside the leg. A second unit with cautery was inserted via the port to cut and seal the tributary branches. A 1 cm skin incision was made near the groin to ligate the distal end of the GSV and remove the vein, which was checked for leakage. The wound was closed with 3-0 skin sutures
16061203|NCT02446509|Behavioral|Psychoeducation|Caregivers will meet once a week for 90-minute sessions in a group setting. Dates and times of the group sessions will be arranged according to the convenience of the subjects. The major content will include the causes of bipolar disorder, signs and symptoms of bipolar disorder, the role of stress and life events, types of medications and what they do, self-management of the disorder, understanding the course of the disorder, genetic and biological predispositions, how the family can help, management of relapse.
16061204|NCT02446509|Behavioral|Psychoeducation - Delayed|The wait list control group will receive the same intervention as the experimental group, but 7 weeks later.
16061205|NCT02446496|Drug|Cefadroxil tablets manufactured by GSK|Cefadroxil tablets manufactured by GSK contains 1 mg of Cefadroxil
16061206|NCT02446496|Drug|Cefadroxil tablets manufactured by NP|Cefadroxil tablets manufactured by NP contains 1 mg of Cefadroxil
16061207|NCT02446483|Drug|Idiazole 20mg DR tabs|Delayed release tablets containing 20 mg of rabeprazole
16061208|NCT02446483|Drug|PARIET 20 mg DR tabs|Orally administered, delayed-release, enteric-coated tablets containing 20 mg of rabeprazole sodium.
16061209|NCT02446470|Procedure|Sinus Tarsi approach|A straight incision is made on the lateral side of the foot from the tip of the fibula to the base of the fourth metatarsal which centers the incision over the sinus tarsi. Then careful dissection is made through the subcutaneous tissues to prevent damage to the sural nerve, peroneal tendons, and extensor digitorum brevis (EDB). The origin of EDB is identified and the muscle is released distal enough to fully visualize the fracture and articular surface of the calcaneus. Following exposure of the fracture and articular surface of the calcaneus, open reduction and restoration of the articular surface of the calcaneus will be achieved followed by stable fracture fixation with plates and screws as dictated by the specific fracture pattern.
16061210|NCT02446470|Procedure|Extensile Lateral approach|An L-shaped incision overlying the lateral wall of the calcaneus will be made, followed by sharp dissection of soft tissues in line with the skin incision down to the periosteum. Effort will be made to identify and protect the sural nerve, as it commonly crosses the surgical field with this approach. The soft tissue flap is retracted as a single unit as subperiosteal dissection is performed. Following exposure of the lateral wall of the calcaneus, open reduction and restoration of the articular surface of the calcaneus will be achieved followed by stable fracture fixation with plates and screws as dictated by the specific fracture pattern.
16061211|NCT02446457|Other|Laboratory Biomarker Analysis|Correlative studies
16061212|NCT02446457|Drug|Lenalidomide|Given PO
16061213|NCT02446457|Biological|Pembrolizumab|Given IV
16061214|NCT02446457|Biological|Rituximab|Given IV
16061215|NCT02446444|Drug|Enzalutamide|
16061216|NCT02446444|Drug|Conventional NSAA|
16061217|NCT02446444|Drug|LHRHA|
16061218|NCT02446444|Radiation|External Beam Radiotherapy (78 Gy in 39 fractions or 46 Gy in 23 fractions plus brachytherapy boost)|
16061219|NCT02446431|Drug|Bevacizumab|Avastin is an anti-angiogenic therapy that disrupts a tumor's ability to grow by blocking the vascular endothelial growth factor protein, or VEGF. In tumors, cells produce excess VEGF therefore avastin's ability to block VEGF may prevent the growth of new blood vessels, including normal blood vessels and blood vessels that feed tumors. Avastin is not a chemotherapy; the purpose of Avastin is to block the blood supply that feeds the tumor. In this study Avastin is given IV at 10 mg/kg twice monthly for 10 cycles. This totals 20 administrations over a 1.12 year period.
16061220|NCT02446431|Drug|Cyclophosphamide|Cyclophosphamide is an alkylating agent related to nitrogen mustard and is inactive until it is metabolized by P450 isoenzymes (CYP2B6, CYP2C9, and CYP3A4) in the liver to active compounds. The initial product is 4-hydroxycyclophosphamide (4-HC) which is in equilibrium with aldophosphamide which spontaneously releases acrolein to produce phosphoramide mustard. Phosphoramide mustard has been shown to produce interstrand DNA cross-link analogous to those produced by mechlorethamine. The plasma half-life ranges from 4.1 to 16 hours after IV administration. Cytoxan is taken orally as a 25 mg/m2 tablet daily for 14 days for 10 cycles (max dose =50mg). This totals 140 days over a 1.12 year period.
16061264|NCT02446210|Device|Digitimer electrical stimulator|Transcranial Magnetic Stimulation paired with Electrical Peripheral Nerve Stimulation
16061265|NCT02446197|Other|Patient Directed Exercise Group|Combination of PT and OT activities that will be individually prescribed based on an evaluation by the therapy team completed pre-intervention. The activities will be added to the comprehensive inpatient rehabilitation program.
16061221|NCT02446431|Drug|Valproic Acid|Valproic acid is a short chain fatty acid (VPA, 2-propylpetanoic acid) and approved for the treatment of epilepsy, bipolar disorders, migraines, and clinically used for schizophrenia. Currently, VPA is examined in numerous clinical trials for different leukemias and solid tumor entities. In addition to clinical assessment, the experimental examination of VPA as anti-cancer drug is ongoing. Although other mechanisms may also contribute to VPA-induced anti-cancer effects, inhibition of histone deacetylases appears to play a central role. Valproic acid is either given in suspension or tablet form 5 mg/kg, TID for 13 days for 10 cycles. This totals 130 days in a 1.12 year period.
16061222|NCT02446431|Drug|Temsirolimus|Temsirolimus [an ester of the immunosuppressive compound sirolimus, (rapamycin, Rapamune®)] blocks cell cycle progression from the G1 to the S phase by binding to the intracellular cytoplasmic protein, FK506 binding protein (FKBP)12. This complex inhibits activity of the enzyme mTOR (mammalian target of rapamycin), inhibiting translation of several key proteins that regulate progression through the G1 phase in response to growth factors. Sirolimus, the major metabolite of temsirolimus, also binds to FKBP12. Given twice monthly at 25 mg/m2 via IV administration for 10 cycles totalling 20 administrations for 1.12 years.
16061223|NCT02446418|Drug|Fluticasone Furoate|FF 92 mcg or 184 mcg blended with lactose administered once daily via ELLIPTA DPI
16061224|NCT02446418|Drug|Vilanterol|Vilanterol 22 mcg blended with lactose and magnesium stearate administered once daily via ELLIPTA DPI
16061225|NCT02446418|Drug|Fluticasone propionate|FP 250 mcg or 500 mcg blended with lactose administered twice daily via DISKUS DPI
16061226|NCT02446418|Drug|Salmeterol|Salmeterol 50 mcg blended with lactose administered twice daily via DISKUS DPI
16061227|NCT02446418|Drug|Budesonide|Budesonide 200 mcg or 400 mcg blended with lactose administered twice daily via TURBUHALER DPI
16061228|NCT02446418|Drug|Formoterol Fumarate|Formoterol Furoate 6 mcg or 12 mcg blended with lactose administered twice daily via TURBUHALER DPI
16061229|NCT02446405|Drug|Enzalutamide|
16061230|NCT02446405|Drug|NSAA|
16061231|NCT02446405|Drug|LHRHA or Surgical Castration|
16061232|NCT02446392|Other|No intervention.|
16061233|NCT02446379|Drug|The marketed product 2-5 MBq/kg 18F-fluorodeoxyglucose|The FDG is injected at least 120 minutes prior to the imaging by the EnLightTM and LightPathTM Imaging Systems
16061234|NCT02446379|Device|EnLightTM|The surgical cavity and the resected lymph nodes (if any) will be imaged by the EnLightTM system to establish whether radioactive tissue remains after surgery.
16061235|NCT02446379|Device|LightPathTM Imaging System|The resected tumour excision specimens and the resected lymph nodes (if any)will be imaged by CLI and by WLI to establish whether they contain radioactive tissue.
16061236|NCT02446366|Other|Laboratory Biomarker Analysis|Correlative studies
16061237|NCT02446366|Other|Quality-of-Life Assessment|Ancillary studies
16061238|NCT02446366|Radiation|Stereotactic Body Radiation Therapy|Undergo hypofractionated SBRT
16061239|NCT02446353|Drug|Apetrol ES / Megace|Sequences of administered drugs
16061240|NCT02446340|Drug|dalazatide|Different doses of drug, subcutaneous injection twice per week for a total of 9 doses.
16061241|NCT02446340|Drug|placebo|Placebo delivered via subcutaneous administration twice per week for a total of 9 doses
16061242|NCT02446327|Other|Blood sampling for biomarker assessment|
16061243|NCT02446314|Dietary Supplement|Placebo|Formulation containing inert artificially colored maltodextrin, once daily, in a 2-hard capsule regimen
16061244|NCT02446314|Dietary Supplement|Wild Blueberry Powder - 450mg|Formulation containing 225 mg wild blueberry powder + 22.5 mg L-Cysteine @ 2.5 mg L-Glutathione 250 mg placebo powder, once daily, in a 2-hard capsule regimen
16061245|NCT02446314|Dietary Supplement|Wild Blueberry Powder - 900 mg|Formulation containing 450 mg wild blueberry powder = 45 mg L-Cysteine + 5 mg L-Glutathione once daily, in a 2-hard capsule regimen
16061246|NCT02446314|Dietary Supplement|Wild Blueberry extract 100mg|Formulation containing 100 mg wild blueberry powder + 10 mg L-Cysteine + 1 mg L-Glutathione + 389 mg of placebo, once daily, in a 2-hard capsule regimen
16061247|NCT02446301|Drug|Bain®|Nalbuphine HCl 20mg, IM injection
16061248|NCT02446301|Drug|SDE|Sebacoyl Dinalbuphine Ester 150mg/2ml, IM injection
16061249|NCT02446288|Device|TMJ Next Generation|
16061250|NCT02446288|Device|DSG Relaxer|
16061251|NCT02446275|Other|Sternocleidomastoid MTRP and stretching|The sternocleidomastoid was treated with ischemic compression. The patient's head was passively moved into contralateral rotation and the patient was asked to relax completely. Sustained pressure was then applied to the sternocleidomastoid muscle until the pain threshold was reached. During the application of pressure, pain decreases so the pressure was gradually increased over a duration of 1 minute. The pressure was then reduced progressively.
16061252|NCT02446275|Other|Trapezius MTRP and stretching|The central MTRP of the trapezius was treated as described above for the sternocleidomastoid. Subsequently stretching was performed, whereby the therapist supported the patient's head and performed passive contralateral inclination and ipsilateral rotation of the head. The therapist placed one hand over the patients shoulder while the other hand performed the stretching and simultaneously controlled the position of the head to achieve suitable stretching
16061253|NCT02446262|Behavioral|Instructions|In sub-study 1, half the participants are instructed about outcomes, half learn through experience.
16061254|NCT02446262|Behavioral|Attention|In sub-study 4, participants learn about outcomes and we manipulate attention toward or away from the pain.
16061255|NCT02446262|Behavioral|Thermal Pain|In sub-studies 2 and 3, participants are exposed to thermal stimuli and/or tastants (sugar water, salt water, neutral rinse) and we are measuring how learning varies based on the type of outcome.
16061256|NCT02446262|Behavioral|Placebo instructions|In sub-study 5, we test whether placebo effects and expectancy cues modulate pain through similar mechanisms.
16061257|NCT02446262|Behavioral|Liquid tastants|MR-compatible, pneumatic-pressurized tastant-delivery system to deliver tastants that are sweet, neutral, or unpleasant.
16061258|NCT02446249|Biological|AAV2hAQP1|Infusion of gene therapy
16061259|NCT02446236|Drug|Lenalidomide|Dose escalation of lenalidomide. Patients will receive 10, 15, 20, or 25 mg PO days 1-21
16061260|NCT02446236|Drug|Ibrutinib|560 mg PO daily
16061261|NCT02446236|Drug|Rituximab|375 mg/m2 IV Day 1
16061262|NCT02446223|Drug|Inggenol Mebutate 0.015%|
16061263|NCT02446210|Device|Magstim 200|Transcranial Magnetic Stimulation
16061266|NCT02446184|Procedure|Fetal Cystoscopy|Fetal cystoscopy will be performed under maternal local anesthesia and fetal anesthesia. The dilated posterior urethra will be directly evaluated. Laser fulguration will be performed in case of posterior urethral valves. However, if a non membrane-like structure is found, even with the fluid injection or the guide-wire, urethral atresia (UA, US or Prune Belly syndrome) will be diagnosed and we will not attempt to perforate this structure. A vesicoamniotic shunting placement will be performed in this situation depending on the patient's consent prior to the surgery.
16061267|NCT02446184|Procedure|Fetal vesicoamniotic shunt|Fetal vesicoamniotic shunt will be performed under ultrasound guidance
16061268|NCT02446171|Drug|Naloxegol 25 mg tablet, crushed, suspended in water, given orally|naloxegol 25 mg (1 tablet) crushed, suspended in water, given orally
16061269|NCT02446171|Drug|Naloxegol 25mg tablet crushed, suspended in water, given via nasogastric tube|naloxegol 25 mg (1 tablet) crushed, suspended in water, given via nasogastric tube
16061270|NCT02446171|Drug|Naloxegol 25 mg (10 mL oral solution)|naloxegol 25 mg (10 mL oral solution)
16061271|NCT02446171|Drug|Naloxegol 25 mg tablet, given orally|naloxegol 25 mg (1 tablet) whole tablet, given orally
16061272|NCT02446158|Drug|Chlorhexidine gluconate|The intervention group received daily cleaning of the exit site and application of 4% chlorhexidine (Antigerm Solution, Shining BioMedical Com. Ltd) with a swab. The chlorhexidine was rinsed off after 3 min of air drying and then gauze was applied.
16061273|NCT02446145|Drug|Eltrombopag|"Patients will receive EPAG in addition to their background standard treatment with Decitabine
~- concomitant medication: Decitabine days 1-5 of each cycle: 20 mg/qm i.v. over 30 minutes"
16061274|NCT02446145|Drug|Placebo|"Patients will receive Placebo in addition to their background standard treatment with Decitabine
~- concomitant medication: Decitabine days 1-5 of each cycle: 20 mg/qm i.v. over 30 minutes"
16061275|NCT02446132|Drug|AVP-786|
16061276|NCT02446119|Device|EndoFLIP|Measurement of pyloric resistance and compliance
16061277|NCT02446106|Dietary Supplement|Soup with MSG|0.5% MSG + 0.48% salt
16061278|NCT02446106|Dietary Supplement|Control soup no MSG|Negative control match for sodium (no MSG + 0.635% salt)
16061279|NCT02446093|Biological|GMCI (aglatimagene besadenovec + valacyclovir)|Three courses of GMCI each involving aglatimagene besadenovec injection into the tumor site followed by 14 days of oral valacyclovir.
16061280|NCT02446093|Drug|Chemotherapy|Standard of care chemotherapy given with radiation
16061281|NCT02446093|Radiation|Radiation|
16061282|NCT02446093|Procedure|Surgery|Pancreaticoduodenectomy (Whipple)
16061283|NCT02446080|Dietary Supplement|Milk drink with probiotic culture|The Probiotc group was asked to drink 150 ml per day of dairy drinks with probiotic culture
16061284|NCT02446080|Dietary Supplement|Milk drink|The control group was asked to drink 150 ml per day of dairy drinks.
16061285|NCT02446067|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|The motor threshold for the left abductor pollicis brevis was determined using a figure-of-eight-shaped coil at 1 Hz frequency. Ten (over 2 weeks) rTMS sessions were administered over the right dorsolateral prefrontal cortex with an air-cooled figure-of-eight coil, angled tangentially to the head. At right DLPFC, active high-frequency (10 Hz) stimulation was administered for 4.9 seconds per train, with inter-train interval of 30 seconds, and a total of 20 trains per session. Each patient received 1000 pulses per day. The sham group was administered rTMS with the same parameters, but using a figure-of-eight sham coil.
16061286|NCT02446054|Dietary Supplement|Musashino T2DM diet|provide Musashino T2DM diet for 12 weeks to T2DM patients, to evaluate the effect on glycosylated hemoglobin (HbA1c), progression and compliance during study period.
16061287|NCT02446041|Other|Non-Interventional Study|Non-Interventional Study
16061288|NCT02446028|Drug|BIOD-531|
16061289|NCT02446028|Drug|Humalog® Mix 75/25|
16061290|NCT02446015|Drug|SYSTANE® ULTRA Lubricant Eye Drops|
16061291|NCT02446002|Drug|Lofexidine + Naltrexone|Lofexidine HCl (two 0.2 mg tablets) will be administered as a single oral dose (0.4 mg) on Day 1 and on Day 11.Commercially available naltrexone HCL tablets will be administered as a single oral 25 mg dose on Day 4 and as a single oral 50 mg dose on Days 5 through 13. On Day 11 administration of both naltrexone and lofexidine will occur. Dose administration times for each drug are to be standardized for all treatment days. The scheduling of the naltrexone dose is to be standardized so that the naltrexone dose is administered 2 hours after the lofexidine dose on Day 11 when both drugs are administered.
16061292|NCT02445989|Drug|NuvaRing|Provide NuvaRing to women seeking contraception
16061293|NCT02445976|Drug|Seviteronel: given orally once daily in 28-day cycles|Oral Seviteronel given once daily, in continuous 28-day cycles at the recommended Phase 2 dose
16061294|NCT02445963|Biological|Shigella flexneri 2a InvaplexAR|The investigational product is S. flexneri 2a InvaplexAR. The product is composed of three individual components IpaB, IpaC, and LPS. The components were assembled into the high molecular weight S. flexneri 2a InvaplexAR complex and subsequently purified by ion-exchange chromatography yielding a bulk lot.
16061295|NCT02445950|Behavioral|Technology-aided phone wellness counselling|The intervention provides phone wellness counselling with the help of web-based interventions, digital profiling and suggestion tool in occupational health.
16061296|NCT02445950|Behavioral|Phone wellness counselling|The intervention provides phone wellness counseling in occupational health.
16061297|NCT02445937|Behavioral|PARTNER II|"The PARTNER intervention is a multifaceted intervention delivered by a trained PARTNER Champion who has undergone 16 hours of intense communication training, with audit and feedback, quarterly booster training, and expert implementation support. Additionally, there is academic detailing of ICU physicians and ICU bedside nurses to augment the intervention. The PARTNER Intervention deploys three strategies to improve: 1) the timeliness and frequency of clinician-family communication, 2) the emotional and decision support provided to families and 3) the appropriate involvement of palliative care specialists."
16061298|NCT02445911|Drug|KQ-791|Capsules administered orally
16061299|NCT02445911|Drug|Placebo|Capsules administered orally
16061300|NCT02445898|Drug|Methylprednisolone|Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride (placebo)
16061301|NCT02445898|Drug|Isotonic Sodium Chloride|Placebo
16061302|NCT02445885|Procedure|PCI|Guideline directed Percutaneous Coronary Intervention
16061379|NCT02445352|Drug|DP-R207 10/10mg|
16061380|NCT02445352|Drug|Rosuvastatin 20mg|
16061303|NCT02445872|Drug|Aprepitant|Aprepitant:The first day, one 125 mg capsule will be administered per oral, 1 hour before chemotherapy. Thereafter one 80 mg capsule will be repeated daily between 8 to 10 a.m. during days 2 to 3
16061304|NCT02445872|Drug|Palonosetron|
16061305|NCT02445872|Drug|Dexamethasone|
16061306|NCT02445859|Drug|Cefuroxime 4 hourly bolus|Cefuroxime loading dose followed by a continuous infusion dosed according to renal function. Dosed to target a serum concentration of 64mg/L.
16061307|NCT02445846|Device|dual HIV/syphilis rapid diagnostics tests|
16061308|NCT02445833|Behavioral|Lifestyle on-line intervention|The self-applied on-line intervention will comprise a behavioural intervention composed by 9 modules seeking to develop gradually achieving the goals of changing eating habits and physical activity in participants (Themes: 1.motivation for change; 2. nutrition and physical activity education; 3. barriers to change, healthy eating principles and how to be active; 4. Influence of thoughts; 5. Emotional eating and self-control; 6. Problem solving; 7. Body image and assertiveness; 8. Relapse prevention)..The program will be established as follows: The first day the participant log in the website where can access the processing modules. A web page was developed specially for this study.
16061309|NCT02445820|Drug|HES|2500 mL of balanced HES 130/0.4
16061310|NCT02445820|Drug|Crystalloid|2500 mL of balanced crystalloid.
16061311|NCT02445807|Drug|DFD06-Cream|Twice daily topical application for 14 days.
16061312|NCT02445807|Drug|Vehicle Cream|Twice daily topical application for 14 days.
16061313|NCT02445794|Drug|Low dose cohort|RT001 is encapsulated di-deutero synthetic homologue of linoleic acid ethyl ester. Each capsule contains 900 mg of RT001.
16061314|NCT02445794|Drug|High dose cohort|RT001 comparator is encapsulated non-deuterated linoleic acid ethyl ester.
16061315|NCT02445781|Device|Glucose clamp|Different levels of hypoglycemia
16061316|NCT02445768|Other|Cognitive multisensory rehabilitation|
16061317|NCT02445742|Drug|Bosutinib|500 mg/day of Bosutinib during the study until disease progression, unacceptable toxicity, or withdrawal of consent occurs
16061318|NCT02445729|Other|Dressing removal at 24 hours|Dressing will be removed 24 hours after cesarean section and wounds will be assessed for healing and presence of infection.
16061319|NCT02445729|Other|Dressing removal at 48 hours|Dressing will be removed 48 hours after cesarean section and wounds will be assessed for healing and presence of infection.
16061320|NCT02445716|Drug|Testosterone|"It consists of a 12-week treatment with 300mcg of transdermal testosterone phase involving three study visits. Participants will attend at the Federal University of Sao Paulo in Brazil for their study visits.
~Participants will be submitted to a physical examination including vital signs and breast and pelvic examination. Women who met the eligibility criteria is invited to attend a baseline randomization visit. They will be randomly assigned in a 1:1 ratio to receive a transdermal testosterone nanoemulsion (0.8g per dose) delivering 300 mcg/day testosterone or an identical placebo provided by Evidence Pharmaceuticals LTDA, SP, BRAZIL.
~Women are asked to return all unused pumps, and treatment compliance was checked by counting weighting returned packs at their final visit."
16061321|NCT02445716|Drug|Placebo|It consists of a 12-week treatment with placebo phase involving three study visits. Participants will attend at the Federal University of Sao Paulo in Brazil for their study visits.
16061322|NCT02445703|Biological|Inactivated Hepatitis A vaccine (HAV)|Dosage of HAV is 250u hepatitis A antigen/0.5ml/dose.
16061323|NCT02445703|Biological|Combined hepatitis A and hepatitis B vaccine (HABV)|Dosage of HABV is 250u hepatitis A antigen and 5µg hepatitis B antigen/0.5ml/dose
16061324|NCT02445677|Device|Active transcutaneous electrical nerve stimulation (TENS)|TENS is a technique use to relieve pain in an injured or diseased part of the body in which electrodes applied to the skin deliver intermittent stimulation to surface nerves and block the transmission of pain signals. In this research, the frequency will be set at 100 Hz, implusion duration at 60 μsec and intensity will be increase until having strong but confortable stimulations.
16061325|NCT02445677|Device|Simulated transcutaneous electrical nerve stimulation (TENS)|A modification of the TENS connexion parameters will prevent the current from reaching the electrods (once a first sensation will be perceived).
16061326|NCT02445664|Behavioral|Educational video|Video: Information on osteoporosis and alendronate treatment.
16061327|NCT02445651|Dietary Supplement|Intravenous and Oral n-acetyl cysteine|
16061328|NCT02445638|Other|Whole egg|Subjects will be provided with the equivalent of 2 whole eggs daily.
16061329|NCT02445638|Other|Yolk-free egg|Subjects will be provided with the equivalent of 2 yolk-free eggs daily.
16061330|NCT02445625|Device|BCI to train joint attention in ASD|The intervention comprehends seven BCI sessions spread over four months. The first four sessions are planned to occur weekly, and the rest monthly. In each session, the subject is asked to identify objects of interest based on the gaze direction of an avatar. The subject response is interpreted from the EEG signal (using the P300 component, as established in our previous work).
16061331|NCT02445612|Biological|MA09-hRPE|Cohort 1 50,000 cells Cohort 2 100,000 cells Cohort 2a Better Vision 100,000 cells Cohort 3 150,000 cells Cohort 4 200,000 cells
16061332|NCT02445599|Drug|Diclofenac|Orally 100 mg Diclofenac, administered 1 hour before surgery
16061333|NCT02445599|Drug|Midazolam|5 mg Dormicum intramuscularly, administered 1 hour before surgery
16061334|NCT02445599|Drug|Atropine|0.5 mg Atropine intramuscularly, administered 1 hour before surgery
16061335|NCT02445599|Drug|bucain + fentanyl|Via the thocacic epidural cannula 1mg/ml bucain + 5microgr/ml fentanyl solution, with 0.1ml/kg body mass/hour speed is administered.
16061336|NCT02445599|Drug|Nalbuphine|1st choice for rescue analgetic 10-20 mg intravenously
16061337|NCT02445599|Drug|Diclofenac|2nd choice for rescue analgetic 250ml intravenously
16061338|NCT02445599|Drug|Metamizole-sodium|Additional rescue analgetic 2g intravenously
16061339|NCT02445599|Drug|Tramadol|Additional rescue analgetic 100mg intravenously
16061340|NCT02445586|Drug|Docetaxel|Participants will receive docetaxel in line with locally approved Prescribing Information. After Cycle 6 (cycle length = 21 days), continuation of docetaxel treatment will be at the discretion of the investigator. Docetaxel will be administered after pertuzumab and trastuzumab.
16061381|NCT02445352|Drug|DP-R207 20/10mg|
16061382|NCT02445352|Drug|Placebo (for Rosuvastatin 5mg and DP-R207 5/10mg)|
16061383|NCT02445352|Drug|Placebo (for Rosuvastatin 10mg and DP-R207 10/10mg)|
16061341|NCT02445586|Drug|Pertuzumab|Participants will receive pertuzumab at an initial dose of 840 milligrams (mg) as a 60-minute intravenous infusion on Cycle 1 Day 1 (cycle length = 21 days), followed by every 3 weeks at a dose of 420 mg as a 30 to 60-minute intravenous infusion until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
16061342|NCT02445586|Drug|Trastuzumab|Participants will receive trastuzumab at an initial dose of 8 milligrams per kilogram (mg/kg) as a 90-minute intravenous infusion on Cycle 1 Day 1 (cycle length = 21 days), followed by every 3 weeks at a dose of 6 mg/kg as a 30 to 90-minute intravenous infusion until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
16061343|NCT02445573|Other|EA|When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In EA group, participants were needled at bilateral BL33 at an angle of 30 to 45 degree inward and downward, and at bilateral BL35 slightly toward upside and outside, to a depth of 50 to 60 mm using acupuncture needles of size 0.30×75 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral BL33 and BL35 (using real electrodes) respectively, with a continuous wave of 50 Hz and a current intensity of 1-5 milliampere (mA) for 30 min. Participants were treated with EA 3 sessions a week on alternate days for 6 successive weeks.
16061344|NCT02445573|Other|sham EA|When acupuncturing, adhesive pads were first pasted on acupoints after sterilization in either group. In sham EA group, participants were needled at sham BL33 and sham BL35, which were about 20 mm lateral to BL33 and BL35, respectively, with blunt needle tips piercing adhesive pads and not piercing the surface of the skin, using placebo needles of size 0.30×25 mm. Needles were then lifted, thrusted and twirled evenly for 3 times. Paired electrodes of EA apparatus were attached transversely to bilateral sham BL33 and sham BL35 (using sham electrodes) respectively. The parameters of sham EA apparatus and the treatment course were the same as in the EA group.
16061345|NCT02445560|Dietary Supplement|Probiotic capsule and Fiber Sachet|"A probiotic capsule and fiber sachet will be consumed daily for 2-weeks. The probiotic capsule contains a mixture of Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium longum, Lactobacillus acidophilus and Lactobacillus plantarum. The fiber sachet consists of 5 g of chicory root fiber.
~During the treatment period, in addition to consuming the probiotic capsule and fiber sachet participants will consume a controlled diet consisting of foods that provide an average of approximately 2 g/kg/day of protein."
16061346|NCT02445560|Dietary Supplement|Probiotic capsule and Placebo sachet|"A probiotic capsule and placebo sachet will be consumed daily for 2-weeks. The probiotic capsule contains a mixture of Bifidobacterium bifidum, Bifidobacterium breve, Bifidobacterium longum, Lactobacillus acidophilus and Lactobacillus plantarum. The placebo sachet consists of 5 g of maltodextrin.
~During the treatment period, in addition to consuming the probiotic capsule and placebo sachet participants will consume a controlled diet consisting of foods that provide an average of approximately 2 g/kg/day of protein."
16061347|NCT02445560|Dietary Supplement|Placebo capsule and Fiber Sachet|"A placebo capsule and fiber sachet will be consumed daily for 2-weeks. The placebo capsule will contain potato starch, magnesium stearate and ascorbic acid. The fiber sachet consists of 5 g of chicory root fiber.
~During the treatment period, in addition to consuming the placebo capsule and fiber sachet participants will consume a controlled diet consisting of foods that provide an average of approximately 2 g/kg/day of protein."
16061348|NCT02445560|Dietary Supplement|Placebo capsule and Placebo sachet|"A placebo capsule and placebo sachet will be consumed daily for 2-weeks. The placebo capsule will contain potato starch, magnesium stearate and ascorbic acid. The fiber sachet consists of 5 g of maltodextrin.
~During the treatment period, in addition to consuming the placebo capsule and placebo sachet participants will consume a controlled diet consisting of foods that provide an average of approximately 2 g/kg/day of protein."
16061349|NCT02445547|Other|UC-MSCs by peripheral intravenous infusion|
16061350|NCT02445547|Drug|received hormone maintenance therapy|
16061351|NCT02445534|Biological|Autologous stem cell therapy|All patients received granulocyte-colony stimulating factor (G-CSF; 5 mg/kg, 5 days). CD34+ cell were then collected by apheresis and injected transendocardially or intracororonary.
16061352|NCT02445508|Drug|Sevelamer|
16061353|NCT02445508|Drug|Cholecystokinin|
16061354|NCT02445508|Drug|Sevelamer placebo|
16061355|NCT02445508|Drug|Isotonic saline|
16061356|NCT02445495|Device|GenesisPlus 1064 nm Nd:YAG laser|Genesis Plus 1064 nm Nd: YAG laser to treat onychomycosis
16061357|NCT02445482|Procedure|Biopsy|archival tissue or fresh biospsy
16061358|NCT02445469|Other|MRI exam of the brain|MRI exam of the brain
16061359|NCT02445456|Drug|Sienna+ injection|Endoscopic injection of magnetic tracer
16061360|NCT02445456|Other|MRI scan|MRI scan of pelvis to detect spread of magnetic tracer
16061361|NCT02445456|Procedure|Surgery to excise rectal cancer|Surgery as scheduled according to size and stage of rectal cancer. This will be either radical surgery or transanal endoscopic microsurgery (TEM)
16061362|NCT02445456|Device|Sentimag probe|Probe to detect the previously injected magnetic tracer (Sienna+)
16061363|NCT02445443|Device|LEGION Hinge Knee System|All enrolled/treated subjects will receive the LEGION Hinge Knee System.
16061364|NCT02445404|Drug|CHOP|cyclophosphamide, 750mg/m² IV day1 doxorubicin, 50 mg/m² IV day1 vincristine, 1.4 mg/m² (max 2 mg) IV day1 prednisone ,40 mg/m² PO day1~5 every 3 weeks
16061365|NCT02445404|Drug|fractionated ICED|ifosfamide, 1.67 g/m² IV day1~3 carboplatin, AUC =5 IV day1 etoposide, 100mg/m² IV day1~3 dexamethasone 40 mg PO or IV day1~4 every 3 weeks
16061366|NCT02445391|Drug|Capecitabine|Given PO
16061367|NCT02445391|Drug|Carboplatin|Given IV
16061368|NCT02445391|Drug|Cisplatin|Given IV
16061369|NCT02445391|Other|Laboratory Biomarker Analysis|Correlative studies
16061370|NCT02445391|Procedure|Quality-of-Life Assessment|Ancillary studies
16061371|NCT02445391|Other|Questionnaire Administration|Ancillary studies
16061372|NCT02445378|Procedure|Aromatherapy and Essential Oils|Undergo aromatherapy and essential oils
16061373|NCT02445378|Other|Placebo|Undergo placebo intervention using rose water
16061374|NCT02445378|Other|Questionnaire Administration|Ancillary studies
16061375|NCT02445365|Device|AutoRIC device|
16061376|NCT02445352|Drug|Rosuvastatin 5mg|
16061377|NCT02445352|Drug|DP-R207 5/10mg|
16061378|NCT02445352|Drug|Rosuvastatin 10mg|
16061384|NCT02445352|Drug|Placebo (for Rosuvastatin 20mg and DP-R207 20/10mg)|
16061385|NCT02445339|Drug|XR-NTX+CM (Extended-Release Naltrexone plus Care Management)|The intervention arm will receive extended-release naltrexone (XR-NTX) 380mg (4 mL) to be administered as an intramuscular gluteal injection every 28 days up to 12 doses total. Expedited referral to alcohol-medical management. Care Management will include coordination of health care and social services for at least 12 months. Harm-reduction counseling and motivational interviewing to identify and work towards goals. The Standard care arm will receive an expedited alcohol-medical management referral.
16061386|NCT02445326|Drug|Dexamethasone|
16061387|NCT02445326|Other|Placebo Vehicle|
16061388|NCT02445313|Device|Nidek MP-3|Nidek MP-3 device to be used to take images which will allow measurement of GA in patients with AMD
16061389|NCT02445300|Other|AQUACEL® Ag Surgical dressing (study group)|The AQUACEL® Ag Surgical dressing was applied to the wound in the operating theater by the surgeon. Clinical indications for removal of the AQUACEL® Ag Surgical dressing were leakage from the dressing beyond the hydrocolloid exterior layer and more than a 50% saturation of the Hydrofiber® inner layer10. If there were no indications to change the dressing, it was changed at the day of discharge usually the 4th or 5th postoperative day (POD) and remained cover of the wound for 7 days except for exudate across the dressing.
16061390|NCT02445300|Other|Sofra-Tulle® dressing (control group)|The Sofra-Tulle® dressing was applied to the wound in the operating theater by the surgeon. The Sofra-Tulle® dressing was routinely changed at a daily basis. If there were strikethrough on the gauze, the nursing staff would proceed the dressing change automatically between the daily routine. After discharge from the hospital, the family who had been taught well to do this job during the patient's stay in the hospital conducted the daily dressing change.
16061391|NCT02445287|Radiation|Radiation|Cadaveric specimens will be imaged with 2D devices: CARESTREAM DRX-Evolution general radiograph and CARESTREAM Cone Beam Computed Tomography (CBCT) general radiograph, and 3D devices PHILLIPS Multi Detector Computed Tomography (MDCT) and CARESTREAM Cone Beam Computed Tomography (CBCT). Human subjects will be imaged with CARESTREAM Cone Beam Computed Tomography (CBCT) 3D only.
16061392|NCT02445274|Procedure|Anterior lens capsule was reserved|The anterior lens capsule was reserved after continuous curvilinear capsulorhexis. The reserved anterior capsule was pressed flattened by the optical surface of the IOL and attached onto the posterior lens capsule.
16061393|NCT02445261|Radiation|mobile phone|Each woman was subjected to 15 minutes CTG trace recording before using mobile phone and repeated while the phone is in the dialing mode for 10 minutes. Umbilical artery (UA) Doppler ultrasound was done after the initial CTG trace and was repeated 5 minutes after hanging up the mobile phone.
16061394|NCT02445248|Biological|CTL019|Single arm
16061395|NCT02445235|Other|Patient Reported Outcome Survey Tool|Patient Reported Outcome Survey Tool
16061396|NCT02445222|Genetic|Previously treated CAR-T patients|Lentiviral-based CAR-T cell therapy
16061397|NCT02445209|Other|EOX|combined chemotherapy regimen: epirubicin + oxaliplatin + capecitabine
16061398|NCT02445209|Other|mDCF|combined chemotherapy regimen: docetaxel + leucovorin + 5fluorouracil + cisplatin
16061399|NCT02445196|Behavioral|PTSD Coach|PTSD Coach is a mobile app that aims to teach individuals self-management strategies for symptoms of PTSD.
16061400|NCT02445196|Device|Smartphone|All participants must have a smartphone, either apple or android.
16061401|NCT02445183|Other|None, N/A|
16061402|NCT02445170|Procedure|Amputation|Transmetatarsal or below-knee amputation
16061403|NCT02445157|Other|4MGS|Measurement of usual gait speed over 4 metres (metres/second)
16061404|NCT02445131|Drug|Bendamustine|Debulking: Cycles 1 - 2, d1 & 2: 70 mg/m2 i.v.
16061405|NCT02445131|Drug|GA101|"Induction: Cycle 1: d1: 100mg, d1(or2): 900mg, d8 & 15: 1000mg; Cycle 2-6: d1: 1000mg
~Maintenance: Cycle 1-8 (Duration 12 weeks): d1 1000 mg."
16061406|NCT02445131|Drug|CAL-101|"Induction: Cycle 2-6: d1-28: 150 mg p.o.
~Maintenance: Cycles 1-8 (Duration 12 weeks): d1-84 150 mg p.o."
16061407|NCT02445118|Other|Adipose Allograft Matrix (AAM) injection|Adipose Allograft Matrix (AAM) injection, Non-dominant wrist
16061408|NCT02445105|Behavioral|Autism Navigator Enhanced Practice|Community service providers will receive training in Autism Navigator for Primary Care, a 6-hour online professional development course with extensive video illustration of the early signs of autism in toddlers, collaborating with families, developmental milestones, screening and referral practices, and early intervention basics. This web-based platform includes an automated screening for communication delay and autism, an automated monthly electronic monitoring, and digital tools for families to address practical obstacles to screening toddlers 9-18 months of age and referral to early intervention.
16061409|NCT02445105|Behavioral|Family Engagement plus Autism Navigator|Community service providers will receive a 6-hour training on the use of Motivational Interviewing, an evidence-based counseling method to improve engagement of families who are ambivalent about screening or intervention for their toddler. Community service providers will also receive a 6-hour training with the Autism Navigator for Primary Care professional development course and use of the web-based platform that includes an automated communication and autism screening and monthly electronic monitoring to address practical obstacles to screening toddlers 9-18 months of age and referral to early intervention.
16061410|NCT02445092|Other|washing the insemination catheter with sperm washing media|"Intervention: pre-washing of the IUI catheter
~Throughout the research period all of the insemination catheters used for patients recruited in our study, will be prepared as follows:
~Connection: The catheter used for insemination, will be connected to the sperm filled syringe as per our standard procedure.
~Catheter washing: The sperm washing media will be aspirated and then flushed through the insemination catheter..
~Sperm loading: catheters washed or not connected to the syringe will be loaded with the washed sperm sample as our standard procedure.
~Labeling:
~Patient identification data will be labeled on the syringe and place back in the original package cover to ensure proper blinding and sterility of the catheter."
16061411|NCT02445079|Other|This is an observational study only|Observational study only
16061412|NCT02445066|Dietary Supplement|Vitamin D3|
16061413|NCT02445053|Drug|ivacaftor|
16061414|NCT02445040|Device|Babylog VN500 in HFOV Mode|Treatment with high frequency oscillatory ventilation with investigational device for up to 14 days
16061415|NCT02445027|Device|MGH OCT Imaging Capsule|Imaging of the esophagus using the OCT Capsule and system.
16063448|NCT02429609|Device|Moorfields Acuity Chart|
16061416|NCT02445014|Device|MGH SECM Imaging Capsule|Imaging of the Esophagus using the SECM capsule and SECM Imaging system
16061417|NCT02445001|Procedure|ICG loaded erythrocytes|For each subject, on the morning of the day angiography was scheduled, or no longer than 4 days prior to angiography, 9 ml of blood will be withdrawn from an antecubital vein. Using sterile procedures, erythrocyte ghosts produced from the blood will be loaded with ICG dye (for the diagnostic part of the study) or with ICG and one of several drugs (for the therapeutic part of the study) by the following procedure, which requires about 2 hours and yields approximately 1 ml of packed cells (80% Ht) that, after microscopic examination, are ready for autologous re-injection
16061418|NCT02444988|Other|0.9% Saline|0.9% Saline will be used whenever an isotonic crystalloid is ordered
16061419|NCT02444988|Other|Physiologically-balanced isotonic crystalloid|Lactated Ringers or Plasma-Lyte© A will be used whenever an isotonic crystalloid is ordered
16061420|NCT02444975|Dietary Supplement|Mineral water|1.5L/day of water on top of the normal fluid intake for 1 year
16061421|NCT02444975|Other|Coaching program|Coaching program to support increased water intake
16061422|NCT02444975|Other|No intervention|No intervention
16061423|NCT02444962|Device|HAVD-implant|hydroxy-apatite coated, acid etched implant for extra oral use to reconstruct craniofacial defects with an episthesis
16061424|NCT02444949|Drug|endostar|
16061425|NCT02444949|Radiation|intensity modulated radiation|
16061426|NCT02444949|Drug|cisplatin|
16061427|NCT02444936|Drug|ZOSTAVAX|Shingles vaccine
16061428|NCT02444923|Device|Scleral rigid gas permeable contact lenses (SRGPcl) (Zenlens™)|Custom manufactured scleral rigid gas permeable contact lenses. These lenses are designed to fit the eye with high level of precision. The aim is to bridge the cornea and fit in alignment with the sclera, thus avoiding any detrimental effects associated with the corneal rigid gas permeable lenses.
16061429|NCT02444923|Device|Corneal Rigid gas Permeable contact lenses (CRGPcl) (Rose K2)|The Rose K2 lens is a widely used corneal gas permeable lens designed for keratoconus and other irregular cornea disorders
16061430|NCT02444910|Drug|KDT501|600mg twice daily, Oral, for 10days; then 800mg twice daily, Oral, for 10 days; then 1,000mg twice daily, Oral, for 8 days.
16061431|NCT02444897|Drug|Epidural PCA Ropivacaine|"Epidural catheter insertion at T10 level before surgery, the tip of catheter location at T8-9 level.
~Total volume: 500ml, 16.7mcg/kg+0.75% Ropivacaine 80ml+N/S"
16061432|NCT02444897|Drug|IV PCA Fentanyl+nefopam+Ramosetron|Total volume: 84ml, Fentanyl 1000mcg+nefopam 120mg+Ramosetron 0.3mg Basal infusion: 1ml/hr, Bolus: 0.5ml with a lockout time 15min.
16061433|NCT02444884|Drug|MLN8237|
16061434|NCT02444858|Biological|UCMSC group|Human umbilical cord MSCs are transplanted by intravenous injection(5×10^5/kg) ，once a day,a total of three times.
16061435|NCT02444858|Other|Control group(Normal saline)|Normal saline in same volume as MSCs are transplanted to patients.
16061436|NCT02444819|Drug|HM61713|HM61713 will be administered to evaluate efficacy and safety of subjects.
16061437|NCT02444806|Other|Full polysomnography|Full sleep and respiratory monitoring with EEG
16061438|NCT02444806|Other|Oximetry-capnography|Limited monitoring with nurse observation and continuous oximetry-capnography overnight for NIV titration.
16061439|NCT02444793|Drug|PF-05082566|Part 1: PF-05082566 dose escalation; Increased doses of PF-05082566 IV are administered at appropriate intervals. Part 2: MTD of PF-05082566 IV established in Part 1 is administered.
16061440|NCT02444793|Drug|KW-0761|Part 1: KW-0761 IV administered at appropriate intervals. Part 2: KW-0761 IV administered at appropriate intervals at the MTD dose for the combination.
16061441|NCT02444780|Procedure|no intervention, blood is sampled for routine|no intervention, blood sampled for standard evaluation will be used for determination of plasma glutamin
16061442|NCT02444767|Drug|13mg Bimatoprost Ocular Insert|13mg Bimatoprost Ocular Insert in each eye.
16061443|NCT02444754|Other|Medical Chart Review|Obtain medical data
16061444|NCT02444754|Other|Questionnaire Administration|Complete demographics questionnaires
16061445|NCT02444754|Other|Survey Administration|Complete surveys
16061446|NCT02444741|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo 3D-CRT
16061447|NCT02444741|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16061448|NCT02444741|Other|Laboratory Biomarker Analysis|Correlative studies
16061449|NCT02444741|Biological|Pembrolizumab|Given IV
16061450|NCT02444741|Radiation|Proton Beam Radiation Therapy|Undergo PBRT
16061451|NCT02444741|Radiation|Radiation Therapy|Undergo low dose radiation therapy
16061452|NCT02444741|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
16061453|NCT02444728|Drug|Hydroxychloroquine|Hydroxychloroquine 200 mg BID for 12 months
16061454|NCT02444728|Drug|Cyclophosphamide|Cyclophosphamide 1000mg intravenous infusion every month for 6 months
16061455|NCT02444728|Drug|Azathioprine|After Cyclophosphamide treatment, Azathioprine 100mg once daily for 6 months
16061456|NCT02444728|Drug|Methylprednisolone|Methylprednisolone 40-50 mg once daily for 1 months and then taped for 12 months
16061457|NCT02444715|Behavioral|Standard care|Participants receive only the usual care including blood analyses, blood pressure controls and individual advice on healthy lifestyle during the outpatient treatment given by the neurologist, by the general practitioner and by other physicians.
16061458|NCT02444715|Behavioral|CAPSYS|In addition to the usual care, patients are asked to call the CAPSYS system twice a week.
16061459|NCT02444689|Behavioral|Electronic Media Application|Children in the intervention group will receive motivation, education and coaching regarding therapeutic lifestyle changes via a smart phone electronic media application.
16061460|NCT02444689|Behavioral|Standard of care education|
16061461|NCT02444676|Other|Stratification and outcomes|No necessary
16061462|NCT02444663|Radiation|Clinician Valgus|Clinician performed valgus stress X-ray under fluoroscopy
16061463|NCT02444663|Radiation|Clinician Varus|Clinician performed varus stress X-ray under fluoroscopy
16061464|NCT02444663|Radiation|Device Valgus|Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed valgus stress X-ray under fluoroscopy.
16061465|NCT02444663|Radiation|Device Varus|Device (Oxford Stress System for Knee Arthroplasty Radiographs (OSSKAR)) performed varus stress X-ray under fluoroscopy.
16061544|NCT02444000|Drug|Radiotherapy+PCV chemotherapy|Radiotherapy followed by 6 cycles of PCV
16061466|NCT02444650|Device|Pulse wave velocity measurement Photoplethysmogram|Correlation of pulse wave velocity measurement.
16061467|NCT02444650|Device|tonometer|
16061468|NCT02444637|Drug|Rivastigmine|
16061469|NCT02444611|Drug|BCG Vaccine|intradermal vaccination
16061470|NCT02444611|Drug|Hepatitis B Vaccine|intramuscular vaccination
16061471|NCT02444598|Device|Vaccum Assisted Closure device|Negative-pressure wound therapy
16061472|NCT02444598|Procedure|Conventional wound dressings|Conventional wound dressings
16061473|NCT02444585|Drug|Denosumab|Intended to prevent periprosthetic loss of bone mineral density
16061474|NCT02444572|Drug|Enoxaparin 4000 IU|
16061475|NCT02444559|Drug|Ropivacaine 20ml 5mg/ml+ Clonidine 150ug|
16061476|NCT02444559|Drug|Ropivacaine 20ml 5mg/ml+ Placebo|
16061477|NCT02444546|Other|Laboratory Biomarker Analysis|Correlative studies
16061478|NCT02444546|Biological|Sargramostim|Given SC
16061479|NCT02444546|Biological|Wild-type Reovirus|Given IV
16061480|NCT02444533|Drug|Liposomal Bupivacaine|Injection of 8 ml of liposomal bupivacaine total in the tonsillar fossae after tonsillectomy.
16061481|NCT02444520|Behavioral|Integrated GP Care|"The overall aims of the intervention are to help the patient:
~develop an understanding of the relationship between cognitive, emotional, physiological and behavioral aspects of their problem;
~understand factors that may be maintaining the problem;
~learn how to modify the behavioral and cognitive responses which may be maintaining the problem;
~adopt a healthy sleep routine which can promote healthy living.
~Hand-outs will be available for GPs to give to patients, but the structure of the intervention allows for treatment to be formulation-based so that particular issues raised in the consultation that might be maintaining symptom severity (e.g. avoidance) can be addressed."
16061482|NCT02444507|Drug|Nexium powder for injection and infusion 40 mg|Reference Drug, Active substance: Esomeprazole 40 mg, Each single dose of esomeprazole 40 mg will be administrated as intravenous infusion over 30 minutes.
16061483|NCT02444507|Drug|Esomelone Powder for Solution for Injection / Infusion 40 mg|Test Drug, Active substance: Esomeprazole 40 mg, Each single dose of esomeprazole 40 mg will be administrated as intravenous infusion over 30 minutes.
16061484|NCT02444481|Drug|Polygynax combinaison of polymyxin, Neomycin and Nystatin|
16061485|NCT02444468|Device|Flowtron ACS800|Flowtron ACS800 and bandage
16061486|NCT02444468|Other|Bandage|Bandage only
16061487|NCT02444455|Biological|UCMSC group|Human umbilical cord MSCs are transplanted by intravenous infusion(5×10^5/kg) once a day,a total of three times.
16061488|NCT02444442|Device|Renal Denervation|Deliberate disruption of the renal nerves via radio frequency energy delivery to renal arteries.
16061489|NCT02444442|Other|Sham control|Arterial access only. No delivery of radio frequency energy to renal arteries.
16061490|NCT02444429|Drug|Corticosteroid boluses Methylprednisolone|"Intensification of the corticotherapy in accordance with the validated protocol for the treatment of classic and subclinical acute rejections: 3 bolus Methylprednisolone 500 mg IV at D1, D2 and D3 then decreasing during 10-15 days at 1mg/kg/d and down to the maintenance dose.
~An anti-pneumocystis and anti-CMV prophylaxis will be systemically introduced for 3 months.
~The rest of maintenance immunosuppressive regimen (mycophenolate mofetil and anti-calcineurin) will remain unaltered"
16061491|NCT02444429|Other|No therapeutic modification|No therapeutic modification: continuation of the corticotherapy at the maintenance dose and maintaining unaltered the rest of immunosuppressive treatment (mycophenolate mofetil and anti-calcineurin).
16061492|NCT02444429|Other|Stop maintenance corticotherapy|Immediate withdrawal of maintenance corticotherapy. Maintaining unaltered the rest of immunosuppressive treatment (mycophenolate mofetil and anti-calcineurin).
16061493|NCT02444416|Procedure|blood sample|
16061494|NCT02444403|Behavioral|Police Education Program designed to align law enforcement and HIV prevention in Tijuana|"The 3.5-hour PEP course consists of 3 modules. Module I covers basic epidemiology, prevention and treatment of HIV, viral hepatitis and STIs, safe syringe disposal and fundamentals of addiction. Post-exposure protocols and appropriate follow-up procedures are outlined. Module II covers key provisions of Mexico's national drug policy (narcomenudeo, which defines amounts of drugs allowed for personal possession), as well as other legal provisions pertinent to HIV prevention, including the legality of syringe and condom possession. Module III covers public health-based interventions targeting PWID (SEPs, OST) and deconstructs myths typical among law enforcement (i.e., drug users do not care about their health, SEPs increase the risk of NSIs).
~A sub-cohort sample will be invited to undergo pre- and post-PEP surveys with semi-annual follow-up for 2 years to assess self-reported NSIs (Aim 1), attitudinal and behavior changes (Aim 2) and mediators/moderators (Aim 3)."
16061495|NCT02444390|Procedure|Biopsy|biopsy of a metastasis
16061496|NCT02444377|Behavioral|Interval training|
16061497|NCT02444364|Drug|Sitagliptin|Subjects will receive 90 tablets of 100mg sitagliptin
16061498|NCT02444351|Drug|botulinum toxin type A (Nabota®) injection into the gastrocnemius muscle|ultrasound-guided botulinum toxin type A (Nabota®, Daewoong co. Seoul, Korea) injection into the gastrocnemius muscle (maximum 200unit per each calf).
16061499|NCT02444351|Other|no intervention|Patients in the control group will not receive any injection on the gastrocnemius muscle.
16061500|NCT02444338|Device|MitraClip|Implantation of the MitraClip System for patients with chronic heart failure.
16061501|NCT02444338|Other|standard of care|
16061502|NCT02444325|Behavioral|Group prenatal care|Women will receive their prenatal care in a group rather than in the 1:1 traditional manner.
16061503|NCT02444312|Behavioral|Benefit-finding Writing Activity|Caregivers will be instructed to write about the benefits of caring, considering things such as improved social relationship, appreciation of life and loved ones, and the positive consequences with respect to these.
16061504|NCT02444312|Behavioral|Neutral Writing Activity|The control group will be instructed to write number of things about the weather that day. Although the sentences can be as long or as short as they like, they will be encouraged to try and aim for about 3 or 4 sentences at least.
16061505|NCT02444299|Device|Shoulder hemi-arthroplasty|
16061506|NCT02444273|Procedure|Exercise|Subjects will be given and individualized exercise program.
16061543|NCT02444000|Drug|PCV chemotherapy alone|"PCV cycles are 6 weeks long
~PCV chemotherapy is given as:
~Day 1: CCNU 110 mg/m2 orally; Days 8 and 29: vincristine 1.4 mg/m2 IV; Days 8 to 21: procarbazine 60 mg/m2 orally"
16061507|NCT02444260|Drug|Midazolam|Midazolam will administered intravenously. 1 mg given stat. Titrated by 1 mg to a maximum dose of 10 mg. Additional sedation will be given to achieve and maintain a score of 2-3 on the Ramsay sedation scale during the procedure, up to the maximum dose of 10mg.
16061508|NCT02444260|Drug|Intravenous Normal Saline|Intravenous normal saline will be infused by non-blinded anaesthetist
16061509|NCT02444260|Drug|Bupivocaine|Bupivcaine 0.25% solution administered by wound infiltration to a maximum dose of 2 mg/kg
16061510|NCT02444260|Drug|Lignocaine HCl|Lignocaine !% solution administered by wound infiltration to a maximum dose of 4.5mg/kg
16061511|NCT02444247|Other|High Dose Exercise (300 kcal)|Subjects will participate in 3 physical activity sessions per week expending 300 kcal per session and rate their liking of exercise.
16061512|NCT02444247|Other|Low Dose Exercise (150 kcal)|Subjects will participate in 3 physical activity sessions per week expending 150 kcal per session and rate their liking of exercise.
16061513|NCT02444247|Other|No Exercise (0 kcal)|Subjects will participate in 3 sessions per week expending 0 kcal per session and rate their liking of exercise.
16061514|NCT02444247|Other|Sedentary Option|Subjects will rate their liking of sedentary activities (reading magazines, playing word games, puzzles) as an alternative to exercise.
16061515|NCT02444234|Drug|Tedizolid PO|Participants will be randomized to receive tedizolid oral 200mg once daily for 3 days and crossed over to IV after a 1 week washout.
16061516|NCT02444234|Drug|Tedizolid IV|Participants will be randomized to receive tedizolid IV 200mg once daily for 3 days and crossed over to PO after a 1 week washout.
16061517|NCT02444208|Behavioral|Active Inhibitory Control Training|Subjects will learn to inhibit responding in the presence of cocaine cues.
16061518|NCT02444208|Behavioral|Neutral Inhibitory Control Training|Subjects will learn to inhibit responding in the presence of neutral cues.
16061519|NCT02444195|Behavioral|Guided Imagery With Audio Media|Subjects assigned to the experimental arm will be asked to participate in meditation daily using the audio media provided for the 7 days prior to surgery, in the preoperative holding area, for the 7 days following surgery, and are encouraged to engage in affirmations module use at least weekly in the 6-8 week postoperative period.
16061520|NCT02444182|Dietary Supplement|Probiotics|A half of the participants will be randomly allocated to the probiotics group. They will receive a probiotics lozenge twice a day for 4 weeks. Pre and Post intervention clinical exam will be conducted
16061521|NCT02444182|Dietary Supplement|Placebo|A half of the participants will be randomly allocated to the placebo group. Lozenges with no probiotics will be given twice daily for 4 weeks. Pre and Post intervention clinical exam will be conducted
16061522|NCT02444169|Device|Ultherapy|Focused ultrasound energy delivered below the surface of the skin.
16061523|NCT02444169|Drug|Incobotulinumtoxin A|An injectable medicine used to temporarily improve the look of moderate to severe frown lines between the eyebrows (glabellar lines) in adults.
16061524|NCT02444169|Device|Radiesse|An injectable dermal filler that temporarily adds volume to help smooth moderate to severe facial wrinkles and folds, such as nasolabial folds (the creases that extend from the corner of the nose to the corner of the mouth).
16061525|NCT02444169|Device|Belotero Balance|An injectable dermal filler to temporarily smooth out and fill in moderate-to-severe nasolabial folds (the folds or wrinkles that go from the side of the nose to the corner of the mouth).
16061526|NCT02444156|Other|Indoor rowing|
16061527|NCT02444143|Drug|tacrolimus extended release|
16061528|NCT02444130|Device|contact lenses|Presbyopia was compensated with contact lenses by monovision and multifocality.
16061529|NCT02444117|Other|functional rehabilitation of social communication|
16061530|NCT02444091|Drug|Cyclophosphamide|Cyclophosphamide intravenous infusions four weeks apart, in total six infusions. First infusion: cyclophosphamide 600mg/m2. Infusions 2 to 6: cyclophosphamide 700 mg/m2 . Follow-up for 12 months.
16061531|NCT02444078|Other|Exercise|Exercise training will take place in the NH, twice weekly, around 60 minutes per session (session duration can be shorter during the first weeks of intervention according with participants' physical capacity), during 6 months; interval between two exercise sessions will be of at least 48 hours. The exercise program will be a multicomponent training, with exercises specifically developed to improve participants' flexibility (10 minutes), coordination and balance (10 minutes), muscle toning (10 minutes), and cardiorespiratory capacity (25 minutes). The exercise intensity targeted will be moderate. All exercise sessions will be accompanied by music.
16061532|NCT02444078|Other|Social Activity|Interventionists will be health professionals external to the NH, preferentially psychologists. Interventions will take place in the NHs, at the same frequency and duration than the exercise intervention (twice weekly, 60 minutes per session, during 6 months).
16061533|NCT02444065|Behavioral|Cognitive Behavior Therapy (CBT)|The CBT intervention is a 4 session (1 hour each) individual psychotherapy intervention that uses a manualized treatment protocol developed by the investigators. It uses standard CBT for eating disorders interventions, including orientation to the CBT model, psychoeducation, commitment and goal setting, behavioral strategies for normalizing eating and reducing bulimic symptoms, planning, and homework. 1-2 sessions are delivered before starting day hospital treatment, and the remaining sessions are delivered in the first weeks of day hospital.
16061534|NCT02444065|Behavioral|Motivational Interviewing (MI)|The MI intervention is a 4 session (1 hour each) individual psychotherapy intervention that uses a manualized treatment protocol (Carter & Bewell-Weiss, 2012). It uses standard MI for eating disorders interventions, including decisional balance, exploring values, readiness and confidence rules, and MI communication strategies. 1-2 sessions are delivered before starting day hospital treatment, and the remaining sessions are delivered in the first weeks of day hospital.
16061535|NCT02444052|Device|Zimmer Puros Cancellous Allograft|Right side will have an extraction followed by an allogenic bone graft zimmer puros followed by implant placement.
16061536|NCT02444052|Device|Nobel Biocare Creos Cancellous Allograft|Left side will have an extraction followed by an allogenic bone nobel biocare creos graft followed by implant placement.
16061537|NCT02444039|Device|SL-D301|Slit Lamp
16061538|NCT02444039|Device|DC-4|Digital Camera Attachment
16061539|NCT02444039|Device|SL-3G|Slit Lamp
16061540|NCT02444026|Behavioral|iCBT for Insomnia|Internet-delivered Cognitive Behavioural Therapy for Insomnia
16061541|NCT02444013|Drug|Folic acid|
16061542|NCT02444013|Drug|Placebo|
16061545|NCT02443987|Other|Intravenous fluid|500ml infusion of 0.9% Sodium Chloride intravenously.
16061546|NCT02443974|Device|Brace (Fisiotensor®)|
16061547|NCT02443974|Device|Sleeve (Fisiotensor®)|
16061548|NCT02443961|Biological|Mesenchymal Stem Cell (MSC) therapy|3 doses of 5 million MSC will be administered
16061549|NCT02443948|Other|Vena puncture for blood collection|Cf-DNA blood samples will be collected in EDTA tubes (20 ml) during the routine blood test
16061550|NCT02443935|Drug|MGN1703|60 mg s.c. twice weekly for 4 weeks
16061551|NCT02443935|Drug|MGN1703|60 mg s.c. twice weekly for 24 weeks
16061552|NCT02443922|Drug|Glimepiride|Glimepiride 2mg qam
16061553|NCT02443922|Drug|Sitagliptin|Sitagliptin 100mg qam
16061554|NCT02443922|Drug|Metformin|Metformin as prescribed
16061555|NCT02443909|Procedure|Retrograde Intrarenal Surgery|endoscopic stone treatment with flexible ureteroscopy and 20w holmium laser device
16061556|NCT02443909|Procedure|Retrograde Intrarenal Surgery|Retrograde Intrarenal Surgery with 30w Holmium laser device(working over 20w power)
16061557|NCT02443909|Procedure|Retrograde Intrarenal Surgery|Retrograde Intrarenal Surgery with 30w Holmium laser device(working under 20w power)
16061558|NCT02443909|Device|Holmium laser device|
16061559|NCT02443896|Procedure|Pit and Fissure Sealant of permanent molars|The tooth is thoroughly cleaned, prepared with a special solution, and dried. The liquid sealant is then applied and allowed to set hard
16061560|NCT02443896|Procedure|No sealant of permanent molars|No sealant applied to permanent molars.
16061561|NCT02443883|Drug|Ramucirumab|Administered IV
16061562|NCT02443857|Device|ChARMin|The aim is to investigate the applicability (technical aspects, patient-related aspects, operability/handling of the robot, the different control modes of the device, safety and the software interface) of ChARMin.
16061563|NCT02443857|Device|ChARMin|The aim is to determine whether differences between game scores, kinematic and kinetic metrics provided by ChARMin, additionally applied physiological measures and adverse events differ when participants train with the free non-supported mode, the assist-as-needed mode and the fully guided mode.
16061564|NCT02443857|Device|ChARMin|The aim is to determine the psychometric properties (validity, reliability and responsiveness) of the assessments integrated in ChARMin.
16061565|NCT02443857|Device|ChARMin|The aim is to describe the application of the system in 30 participants and evaluate the concomitant changes in upper extremity motor function (open labelled interventional study without control group).
16061566|NCT02443857|Device|ChARMin|The aim is to perform specific motor learning studies in 120 patients investigating whether children with neurological diagnoses can improve arm and hand task performance during repetitive training with ChARMin, are able to retain improved levels of task performance and how task performance is influenced by other interventions.
16061567|NCT02443857|Device|ChARMin|The aim is to perform an ecological study monitoring safety, functional progress and (changes in) the application of ChARMin in 120 participants following an in- or out-patient program (comparable to subproject ChARMin-4).
16061568|NCT02443844|Procedure|Transurethral Resection|Endoscopic treatment of bladder cancer
16061569|NCT02443844|Drug|Tamsulosin|Medical treatment for benign prostate hyperplasia
16061570|NCT02443831|Procedure|Leukapheresis|Patients will undergo an unstimulated leukapheresis to isolate the required immune cells to produce the CD19 CAR T-cells
16061571|NCT02443831|Drug|Lymphodepletion with fludarabine|Patients will receive lymphodepleting chemotherapy with iv fludarabine 30 mg/m2 on days -7 to -3 prior to CD19CAR T-cell infusion.
16061572|NCT02443831|Drug|Lymphodepletion with cyclophosphamide|Patients will receive lymphodepleting chemotherapy with iv cyclophosphamide 0.5 g/m2 on days -4 to -2 prior to CD19CAR T-cell infusion.
16061573|NCT02443831|Biological|CD19 CAR T-cells|A single dose of 1 x 10^6/kg CD19CAR transduced T-cells will be given as an intravenous injection through a Hickman line or PICC line(peripherally inserted central catheter) on day 0.
16061574|NCT02443818|Drug|Sirolimus|Low dose sirolimus will be given in daily dosing to achieve trough levels of 2-6 ng/ ml.
16061575|NCT02443805|Biological|300 IR|300 IR tablet of HDM Allergen Extracts
16061576|NCT02443805|Biological|Placebo|Placebo tablet
16061577|NCT02443792|Procedure|Unicirc with tissue adhesive|As above
16061578|NCT02443792|Procedure|Open Surgical|As above
16061579|NCT02443766|Other|Meditation Retreat|Weeklong retreat which includes meditation and prayer.
16061580|NCT02443753|Device|EndoBarrier SANS|Eligible subjects will be implanted with the EndoBarrier® SANS™ Device for a period of 3 months. The GI Dynamics' EndoBarrier® SANS™ is an endoscopically positioned device that represents an alternative to the use of gastric bypass operative techniques as a means of re-routing food and altering the gut-hormone axis. The EndoBarrier® SANS™ provides an alternate passage of chime through the duodenum and proximal sixty centimeters of jejunum replicating in part the bypass of bariatric surgery.
16061581|NCT02443740|Drug|BIIB118|Single ascending doses of BIIB118 as extemporaneously prepared solution/suspension, once every 2 week in a cross over study: 3 mg, 30 mg, 200 mg, 800 mg and placebo
16061582|NCT02443740|Drug|BIIB118|Single ascending doses of BIIB118 as extemporaneously prepared solution/suspension, once every 2 week in a cross over study: 10 mg, 100 mg, 400 mg, and placebo
16061583|NCT02443740|Drug|BIIB118|Single dose (Maximum Tolerated Dose) of BIIB118 as extemporaneously prepared solution/suspension
16061584|NCT02443727|Drug|Syntocinon (synthetic oxytocin)|Dosage and details described in arm.
16061585|NCT02443727|Other|Placebo|Dosage and details described in arm.
16061586|NCT02443714|Device|Needle-free jet injection with insulin lispro|Subjects injected by jet injectors which deliver insulin lispro
16061587|NCT02443714|Device|Conventional pen injection with insulin lispro|Subjects injected by conventional insulin pens which deliver insulin lispro
16061588|NCT02443701|Other|Exercise|Warmup program, maximum isometric strengthening, and jump training
16061589|NCT02443701|Other|LASER|a cluster with 03 diodes with 850nm wavelength and the following parameters: Power 50mW diode, diode energy by 2J, power per point of 6J, totaling 36J per member
16061590|NCT02443701|Other|NMES|electrical stimulation, medium frequency current (1kHz), Burst duration equal to 2ms with, modulated at 70Hz, cycle Work 10% T-on and T-10 seconds off and 30 seconds intensity used will vary according to the capacity and tolerable for each individual
16061593|NCT02443662|Other|Catheterization|Routine catheterization during follow up.
16061594|NCT02443649|Behavioral|Sleep hygiene program|Sleep hygiene program
16061595|NCT02443649|Behavioral|Sleep hypnosis|Hypnosis recording with personalized goals and imagery for sleep improvement
16061596|NCT02443623|Biological|Vaccination with ACAM2000|In this study (VA-008), healthy adult male and female volunteers who meet the requirements for source plasma donors and study entry criteria will be vaccinated with the ACAM2000 smallpox vaccine for collection of plasma to be used in the manufacture of VIGIV. There are possible risks associated with ACAM2000 vaccination. To ensure the safety of plasma donors, risk factor screening procedures and the collection of post-vaccination safety data will be assessed throughout the study.
16061597|NCT02443597|Other|ultrasound|trans abdominal or trans vaginal ultrasound to detect some of the soft markers of trisomy screening
16061598|NCT02443584|Other|pharmacogenetic testing|pharmacogenetic testing for anti-depressant/anti-psychotic medications
16061599|NCT02443571|Radiation|Fluciclovine (18F)|Not applicable. This is an observational study.
16061600|NCT02443558|Other|Brain-Computer Interface control of robotic arms.|The patients will be trained to modulate self-paced Visual Motor Imagery (VMI) and Kinesthetic Motor Imagery (KMI) under EEG recording in order to achieve BCI-control of a custom-built bimanual arms robot (MERCURY v2.0). In KMI they will be asked to modulate brain waves in order to learn to control the BCI and in VMI they will additionally be projected a visual cue (representation of the intended movement).
16061601|NCT02443558|Device|MERCURY v2.0 robotic arms|MERCURY v2.0 robotic arms is a non-commercial 6-degree-of-freedom anthropomorphic bimanual robotic arms device that was built and developed by the research team of the Medical Physics Lab.
16061602|NCT02443545|Drug|Deferiprone|
16061603|NCT02443532|Behavioral|Structured group education|The group intervention consists of interactive sessions for groups of 5-7 patients, dealing with different aspects of management of type 1 diabetes: insulin therapy and hypoglycemia, management of insulin doses, diet, physical exercise, sick days, etc. The intervention is designed for the acquisition of specific skills of self-management. This intervention is provided by a team including physicians, dietitians, and nurses.
16061604|NCT02443532|Behavioral|Individual education|Usual care (individual consultations as routinely performed)
16061605|NCT02443519|Behavioral|MBCT for Migraine|8 75-90 minute individual sessions of the manualized Mindfulness-based Cognitive Therapy plus a manual and homework
16061606|NCT02443506|Drug|AMG 623|Single dose of AMG 623 administered as subcutaneous and intravenous doses
16061607|NCT02443506|Drug|Placebo|Single dose of matching AMG 623 placebo administered as subcutaneous and intravenous doses
16061608|NCT02443493|Device|Low-level laser|Low-Level Laser Therapy will be applied, twice a week, from the start of radiotherapy treatment (14 sessions in total) in combination with the standard skin care.
16061609|NCT02443493|Device|sham laser|Sham Laser Therapy will be applied, twice a week, from the start of radiotherapy treatment (14 sessions in total) in combination with the standard skin care.
16061610|NCT02443493|Radiation|radiotherapy|
16061611|NCT02443467|Other|No intervention|
16061612|NCT02443454|Device|Device: Complior Analyse System|Monitoring of Arterial Stiffness and Central Aortic Pressure
16061613|NCT02443454|Device|Tanita BC 418- Bioelectrical impedance analysis|The device measured the size of total body water (TBW), fat mass (FM%), visceral fat%, fat free mass (FFM), and basal metabolic rate (BMR) (kcal).
16061614|NCT02443402|Drug|Sitagliptin|Subjects will take one pill daily until the day prior to them being discharged from the hospital. Sitagliptin will be dispensed orally at 100 mg/day and at a lower dose 50 mg for patients with glomerular filtration rate (GFR) < 30-50. If the calculated GFR drops to 30 mL/min/1.73m2 or below, patients will receive study medication 25mg daily
16061615|NCT02443402|Drug|Placebo|One pill daily until discharge
16061616|NCT02443402|Drug|Regular Human Insulin|Continuous intravenous insulin given to ICU patients with a BG > 180 mg/DL for two consecutive readings and will be started on Regular Human Insulin adjusted to achieve and maintain a BG target between 110 - 180 mg/dL following standard hospital protocol. Intravenous insulin infusion will be continued until the patient is able to eat and/or transferred to non-ICU service. In previous studies, average length of insulin infusion in patients with stress hyperglycemia was 16.9±19 hours and the amount of IV insulin requirement was 18.6±24.3 U/day.
16061617|NCT02443402|Drug|Insulin glargine|"When regular insulin is discontinued, if needed, insulin glargine will be given once daily. Patients who required continuous insulin infusion at an average rate >2U/h will be transitioned to basal (to be given approx. 4 hours prior to discontinuing the insulin drip) starting at a dose 0.2 U/Kg/d.
~Subjects with a BG at 140-200 mg/dL will start glargine at 0.2 U/kg weight per day. And subjects with BG between 201-400 mg/dL will start glargine at 0.2 U/Kg/day
~The basal insulin dose will be adjusted as follow:
~If fasting and pre-dinner BG is between 100 - 180 mg/dL in the absence of hypoglycemia the previous day: no change
~If fasting and pre-dinner BG is between 180 - 240 mg/dL in the absence of hypoglycemia: increase glargine by 10% every day
~If fasting and pre-dinner BG is > 241 mg/dL in the absence of hypoglycemia the previous day: increase glargine dose by 20% every day
~If fasting and pre-dinner BG is < 100 mg/dL in the absence of hypoglycemia: stop glargine"
16061618|NCT02443402|Drug|Supplemental insulin (Insulin lispro)|"Insulin lispro will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol. At bedtime, half of supplemental sliding scale insulin starting at BG >240 mg/dL will be given.
~For the subjects receiving supplemental insulin lispro with BG levels greater than 180 mg/dL, then supplemental insulin scale is as follows:
~BG between 181-220 mg/dL; 2-4 units of insulin lispro
~BG between 221-260 mg/dL; 3-5 units of insulin lispro
~BG between 261-300 mg/dL; 4-6 units of insulin lispro
~BG between 301-350 mg/dL; 5-7 units of insulin lispro
~BG between 351-400 mg/dL; 6-8 units of insulin lispro
~BG > 400 mg/dL; 7-9 units of insulin lispro"
16061619|NCT02443402|Drug|Supplemental insulin (Insulin aspart)|"Insulin aspart will be administered before meals in addition to scheduled insulin dose following the supplemental insulin scale protocol. At bedtime, half of supplemental sliding scale insulin starting at BG >240 mg/dL will be given.
~For the subjects receiving supplemental insulin aspart with BG levels greater than 180 mg/dL, then supplemental insulin scale is as follows:
~BG between 181-220 mg/dL; 2-4 units of insulin aspart
~BG between 221-260 mg/dL; 3-5 units of insulin aspart
~BG between 261-300 mg/dL; 4-6 units of insulin aspart
~BG between 301-350 mg/dL; 5-7 units of insulin aspart
~BG between 351-400 mg/dL; 6-8 units of insulin aspart
~BG > 400 mg/dL; 7-9 units of insulin aspart"
16061620|NCT02443376|Device|Complior Analyse System|Pulse Wave Velocity PWV and central Pressure analysis
16061621|NCT02443376|Device|BCM- Body Composition Monitor|"BCM - Body Composition Monitor gives information about:
~Overhydration Urea distribution volume (V) Total body water, extracellular and intracellular water Lean Tissue Index (LTI) Fat Tissue Index (FTI) Body Cell Mass (BCM)"
16061622|NCT02443363|Other|Estimating of formula MDRD, CKD-EPI, Cockroft-Gault,|
16061623|NCT02443363|Device|Tanita BC 418- Bioelectrical impedance analysis|The device measured the size of total body water (TBW), fat mass (FM%), visceral fat%, fat free mass (FFM), and basal metabolic rate (BMR) (kcal).
16061624|NCT02443337|Drug|LY3023414|Administered orally
16061625|NCT02443337|Drug|Necitumumab|Administered IV
16061626|NCT02443324|Drug|Ramucirumab|Administered IV
16061627|NCT02443324|Drug|Pembrolizumab|Administered IV
16061628|NCT02443311|Drug|Pimecrolimus 1% cream|Patients were instructed to apply a thin layer of mixed equal amounts (½ ml) of the study medication and the adhesive gel base per application guided by the graduation on the plastic syringe on the oral lesions, 4 times daily, for a total of 1month. The patients were asked not to eat, drink, for 30 minutes after each application.
16061629|NCT02443311|Drug|Betamethasone 17-valerate 0.1% cream|Patients were instructed to apply a thin layer of mixed equal amounts (½ ml) of the study medication and the adhesive gel base per application guided by the graduation on the plastic syringe on the oral lesions, 4 times daily, for a total of 1month. The patients were asked not to eat, drink, for 30 minutes after each application.Topical antifungal Miconazole 2% gel (Miconaz, oral Medical Union Pharmaceutical, Cairo, Egypt) was applied only in the fourth week of treatment period to avoid secondary candidiosis
16061630|NCT02443298|Drug|placebo|Matching placebo for risankizumab
16061631|NCT02443298|Drug|risankizumab|Monoclonal IgG antibody
16061632|NCT02443285|Drug|Cefotaxime|Cefotaxime 2 gram every12 hours for 5 days
16061633|NCT02443285|Drug|ceftriaxone|Ceftriaxone 2 gm every 24 hours for 5 days
16061634|NCT02443272|Procedure|Vessel Loop Drainage|Minimally invasive approach will utilize a vesi-loop device for the vessel loop drainage technique by placing 2 peripheral stab incisions into the abscess with a tunnel through the abscess cavity, and loop passed through the tunnel and tied atop the skin.
16061635|NCT02443272|Procedure|Incision and Drainage|Standard of care treatment will utilize incision and drainage over the center of the abscess cavity with or without packing at physicians discretion.
16061636|NCT02443246|Drug|Vitamin D3 B.O.N. Injection (cholecalciferol 200,000IU)|
16061637|NCT02443246|Drug|Placebo|
16061638|NCT02443220|Device|TEAS (transcutaneous electric acupoint stimulation)|"transcutaneous electric acupoint will commence at 30 min on Danzhong and Hegu before anesthesia in distal-proximal group"
16061639|NCT02443220|Device|TEAS|"transcutaneous electric acupoint will commence at 30 min on Danzhong and Juque before anesthesia in regional group"
16061640|NCT02443220|Device|TEAS|"The device will be connected to Danzhong and Hegu but no stimulation to the acupoints 30 min before anesthesia"
16061641|NCT02443194|Drug|duloxetine|after randomization the patient will receive cymbalta/ placebo for 3 months
16061642|NCT02443194|Drug|PLACEBO|after randomization the patient will receive cymbalta/ placebo for 3 months
16061643|NCT02443181|Device|Activa PC+S|Implementation of closed loop DBS for essential tremor
16061644|NCT02443168|Drug|AG-221|Part 1: oral solution containing 100 mg [14C]-AG-221
16061645|NCT02443168|Radiation|14C AG-221|5 mL of 100 micrograms [14C] AG-221 given intravenously 4 hours after swallowing the formulated tablet.
16061646|NCT02443155|Drug|NNC0114-0006|NNC0114-0006 12 mg/kg administered i.v (intravenously) every 6 weeks. Subjects will continue their pre-trial insulin treatment
16061647|NCT02443155|Drug|liraglutide|Liraglutide 1.8 mg administered s.c. (subcutaneously) daily. Subjects will continue their pre-trial insulin treatment
16061648|NCT02443155|Drug|placebo|Placebo administered s.c (subcutaneously) or i.v ( intravenously). Subjects will continue their pre-trial insulin treatment
16061649|NCT02443142|Drug|Ibuprofen|Ibuprofen 800 mg orally three times per day for two days for study subjects who are randomized to the ibuprofen arm.
16061650|NCT02443142|Drug|Acetaminophen|Acetaminophen 1000 mg orrally three times per day for two days for subjects who are randomized to the acetaminophen arm.
16061651|NCT02443129|Device|DRI-1 Swept source OCT, Atlantis, Topcon|Fundus imaging
16061652|NCT02443116|Biological|NGM282|
16061653|NCT02443116|Other|Placebo|
16061654|NCT02443103|Drug|Guanabenz acetate|
16061655|NCT02443090|Drug|fispemifene|
16061656|NCT02443090|Other|Placebo|
16061668|NCT02443064|Drug|Vancomycin|"Vancomycin was administered for Chinese patients with MRSA blood stream infection and endocarditis Pharmacokinetics: 5 blood samples collected at steady state for the determination of plasma concentrations for population pharmacokinetics (PPK) analysis.
~Microbiology: blood cultures for MRSA isolation, MIC of vancomycin against MRSA; molecular typing will be analyzed on bacterial strains including heterogeneous vancomycin-intermediate Staphylococcus aureus (hVISA) and vancomycin-intermediate Staphylococcus aureus （VISA); Safety evaluation: hepatic and renal function, blood routine test, and so on."
16061669|NCT02443051|Behavioral|Attention Bias Modification|Computer delivered modification in 80% of trials
16061710|NCT02442700|Drug|pitavastatin|Treatment A = administration pitavastatin for 12 weeks
16061711|NCT02442700|Drug|placebo|Treatment B = administration placebo for 12 weeks
16061712|NCT02442687|Drug|JKB-121: 5 mg twice daily|
16061670|NCT02443038|Other|Yoga|"16 bi-weekly 50-60 minute yoga classes, followed by daily, 10 minute home exercise poses and 5 minute relaxation, the control group will practice 5 minutes relaxation, each day between classes.
~The first of 3 classes is the 8-10 member advisory board, the second and third classes with 10-15 participants in each workshop will be held in other counties. There will be 2-3 months between the first set of classes and second and third set of classes to refine methods and conduct enrollment and testing for the subsequent groups."
16061671|NCT02443025|Behavioral|Teens Against Tobacco Use|Teens Against Tobacco Use teen teachers develop and then deliver anti-tobacco presentations to the target population of younger students.
16061672|NCT02443012|Drug|Topical Gutt Nepafenac 0.1%|Topical Nepafenac as an adjunct to focal/grid laser
16061673|NCT02443012|Procedure|Laser|Grid/Focal Laser Photocoagulation
16061674|NCT02442999|Other|Screening for obstructive sleep apnea|
16061675|NCT02442999|Device|CPAP - continuous positive airway pressure|
16061676|NCT02442973|Procedure|Control group (CG): standard practice|Standard practice group
16061677|NCT02442973|Procedure|Ultrasound group (UG):|"SpineView3D™ anatomical scouting approach"
16061678|NCT02442973|Device|Accuro SpineView3D™|subject will be scanned with 'Accuro SpineView3D
16061679|NCT02442960|Drug|Herbal treatment (SA100)|This treatment has been used extensively in traditional medicine practices for hundreds of years.
16061680|NCT02442947|Other|clothing type, protective garments of Paul Boye Technologies|The experiment aimed at evaluating the physiological stress obtained when dressed in different clothing (NBC protective garment [charcoal base], combat garment and 2 different types of work uniforms- (1)50% cotton and 50% polyester (2)80% cotton and 20% polyester) and during exertion under heat conditions.
16061681|NCT02442934|Other|Administration of the IPREA3 questionnaire|On the day of the ICU discharge, the bedside nurse administers to the patient the 18-item IPREA questionnaire i.e the nurse asks the patient to rate the severity of each discomfort source contained in the IPREA3 questionnaire experienced during the entire stay in the ICU
16061682|NCT02442934|Other|Immediate feedback through electronic reminder messages|After the nurse had administered the questionnaire, warning messages are displayed on the screen corresponding to the key points to prevent the three discomforts reported with the highest scores
16061683|NCT02442934|Other|Targeted interventions in each ICU to reduce discomforts|"These targeted interventions are implemented through the coordination of two local champions.
~The central coordination IPREA3 team sends each month to the local champions monthly and cumulative discomfort scores of their unit (overall score of discomfort and scores for each item) and their ranking relative to other units assigned to the interventional arm i.e applying the IPREA3 program.
~The local champions organize monthly meetings with the unit staff to present the results in terms of perceived discomforts measured by the IPREA questionnaire, identify main discomfort sources and actions to be conducted to reduce the discomforts reported with the highest scores in the unit and those that are most easily preventable, and assess the efficacy of already applied measures."
16061684|NCT02442921|Drug|Colchicine|up to 2mg of Colchicine daily
16061685|NCT02442921|Drug|Placebo|Daily placebo
16061686|NCT02442908|Dietary Supplement|Nutrifriend Cachexia|2 daily for 12 weeks
16061687|NCT02442908|Dietary Supplement|Isocaloric placebo|2 daily for 12 weeks
16061688|NCT02442869|Behavioral|Stage 1 Treatment as usual (TAU)|4-8 weeks of the treatment typically provided by that counselor with the caveat that neither DBT nor CAMS can be provided.
16061689|NCT02442869|Behavioral|Stage 1 CAMS|4-8 weeks of Collaborative Assessment and Management of Suicidality (CAMS)
16061690|NCT02442869|Behavioral|Stage 2 CAMS|4-16 weeks of Collaborative Assessment and Management of Suicidality (CAMS)
16061691|NCT02442869|Behavioral|Stage 2 Dialectical Behavioral Therapy (DBT)|4-16 weeks of Dialectical Behavioral Therapy (DBT)
16061692|NCT02442856|Device|Thigh Cuff|
16061693|NCT02442843|Device|Active tDCS|Participants will be randomized into active or sham stimulation in the first tDCS session. Participants will then have the option to complete 9 additional session of tDCS which will be active tDCS or a combination of active and sham tDCS in a non-randomized manner over two consecutive weeks. Each session will last 1 - 2 hours.
16061694|NCT02442843|Device|Sham tDCS|Participants will be randomized into active or sham stimulation in the first tDCS session. Participants will then have the option to complete 9 additional session of tDCS which will be active tDCS or a combination of active and sham tDCS in a non-randomized manner over two consecutive weeks. Each session will last 1 - 2 hours.
16061695|NCT02442830|Device|Early Video Capsule Endoscopy|"The intervention is the use of video capsule endoscopy as the first test in a patient presenting to the ED with active bleeding. The capsule allows for visualization of the entire GI tract.
~Once a capsule has been given to a study patient, a staff member will use the capsule's real-time viewer to see if there is any active bleeding in the stomach. If bleeding is seen the investigators will pursue an upper endoscopy. If no bleeding is seen a staff member will review the entire findings of the capsule and make a decision regarding which therapeutic measure to pursue."
16061696|NCT02442817|Drug|Linagliptin|12 weeks of treatment and week for assessment. Linagliptin, 5 mg by mouth once per day for 12 weeks, in combination with continued antipsychotic treatment.
16061697|NCT02442804|Dietary Supplement|POMx|Pomegranate supplement (1g) by mouth twice per day for 7 days
16061698|NCT02442804|Other|Placebo|Placebo (for POMx, containing no antioxidant contents; 1g) capsule by mouth twice per day for 7 days
16061699|NCT02442791|Drug|Byetta (Lilly, Exenatide)|See description of Arms
16061700|NCT02442791|Other|20% Human Albumin|See description of Arms
16061701|NCT02442778|Drug|AVP-786|
16061702|NCT02442778|Drug|Placebo|
16061703|NCT02442765|Drug|AVP-786|
16061704|NCT02442765|Drug|Placebo|
16061705|NCT02442752|Drug|Dexlansoprazole|Dexlansoprazole capsules
16061706|NCT02442739|Drug|Ketamine|Ketamine 0.5 mg/kg mixed with syrup will be given by mouth once a week for 12 weeks.
16061707|NCT02442739|Other|Placebo|Placebo syrup will be given by mouth once a week for 12 weeks.
16061708|NCT02442726|Device|CO2-Laser stimulation (Laser Stimulation Device, SIFEC)|Laser stimuli are evenly applied in 15 spots (each 6 mm in diameter) in the primary hyperalgesic zone (application zone of the contact thermode) and in the secondary hyperalgesic zone (1 cm outside the application zone of the contact thermode).
16061709|NCT02442713|Drug|fluvoxamine|fluvoxamine: 50-300mg/day
16061715|NCT02442674|Drug|Tolvaptan|"Tolvaptan 3.75-, 7.5-, 15-, and 30-mg Tablets.
~Dosage: Depending on age, weight and serum sodium response:
~Tablet (3.75 mg - 60 mg daily) Frequency: Once daily Duration: 30 (+2) days"
16061716|NCT02442674|Other|Placebo|Placebo tablet matching active drug
16061717|NCT02442648|Drug|Carfilzomib|Carfilzomib will be administered for desensitization per study protocol.
16061718|NCT02442648|Drug|Rituximab|Rituximab will be administered for desensitization per study protocol.
16061719|NCT02442635|Behavioral|Yoga|Yoga breathing and postures; After this initial 3 arm experiment, yoga breathing and postures will be studied in combination.
16061720|NCT02442622|Other|Occupational therapy|Occupational therapy for de Quervain's Tenosynovitis
16061721|NCT02442622|Device|Occupational therapy with ASTYM|Occupational therapy for de Quervain's Tenosynovitis plus ASTYM
16061722|NCT02442609|Other|questionaire|questionaire before surgery
16061723|NCT02442583|Other|Brochure regarding sedentary behavior|This pilot will occur in two phases. Phase 1 will occur in two steps. In Step 1, we will conduct one-on-one telephone interviews with 15 early stage CRC (colorectal cancer) survivors to obtain their knowledge and insights about sedentary behaviors and ways to reduce them. Their input will be used to help create a brochure on sedentary behaviors. In Step 2, we will conduct one-on-one telephone interviews with 5 early stage CRC survivors to provide feedback about the brochure. In Phase 2, we will recruit 15 CRC survivors. After completing a baseline survey, they will be asked to both wear an ActiGraph and self-report their daily sedentary behaviors for one week. They will receive tailored feedback as to their average weakly levels of sedentary behaviors and receive the brochure. One month post-intervention, they will be asked to take part in telephone survey assessing sedentary behaviors, PA (physical activity), and use of brochure.
16061724|NCT02442570|Biological|recombinant human alpha B-crystallin|intravenous injections
16061725|NCT02442570|Other|Placebo comparator|intravenous injection
16061726|NCT02442557|Biological|recombinant human alpha B-crystallin|intravenous injection
16061727|NCT02442557|Other|placebo comparator|intravenous injection
16061728|NCT02442544|Dietary Supplement|Prebiotic|1:1 oligofructose: inulin 8 g orally /day
16061729|NCT02442544|Dietary Supplement|Placebo|maltodextrin 3.3g orally/day
16061730|NCT02442531|Drug|CriPec® docetaxel|-3 weekly IV dose. Dose escalation; start dose 15 mg/m2. Number of cycles: 6 or until progression or unacceptable toxicity develops
16061731|NCT02442518|Procedure|antenatal ultrasound|Transabdominal and Transvaginal ultrasound examinations were performed in the third trimester (with some fluid in the bladder so that the uterine bladder interface could be evaluated well).
16061732|NCT02442505|Device|Microlife WatchBP03 device|Microlife WatchBP03 device which is an automated oscillometric device using a new algorithm to detect atrial fibrillation
16061733|NCT02442492|Drug|Sildenafil|Sildenafil 25 mg tablets three times daily orally from randomization until delivery or 31+6 weeks of gestational age, whichever is sooner.
16061734|NCT02442492|Drug|Placebo|Placebo 25 mg tablets three times daily orally from randomization until delivery or 31+6 weeks of gestational age, whichever is sooner.
16061735|NCT02442479|Behavioral|resistance training|
16061736|NCT02442466|Drug|Endothelin Receptor B inhibitor BQ788|
16061737|NCT02442466|Drug|PBS|
16061738|NCT02442453|Drug|Topical application of curenext gel|Topical application of curcuma longa gel along with scaling and root planing in chronic periodontitis subjects
16061739|NCT02442453|Drug|Placebo|Topical application of placebo gel along with scaling and root planing in chronic periodontitis subjects
16061740|NCT02442440|Drug|anisodamine|Anisodamine will be given first as bolus of 10 mg, followed by 0.1-0.5mg/kg/hr. The adjustment of pump infusion rate is largely at the discretion of treating physician, with the aim of improving microcirculation and limit the side effect to a minimum. For example, if serum lactate continues to elevate, the infusion rate can be increased. Discontinuation on severe side effect or recovery of shock (normalized lactate, weaned from vasopressor) or death.
16061741|NCT02442427|Drug|Palivizumab|A single dose of IV palivizumab 15 mg per kilogram body weight (maximum dose =100 mg). The study medication will be given by IV infusion over 30 minutes using a syringe infusion pump.
16061742|NCT02442427|Other|Placebo|An equal volume of 0.9% normal saline
16061743|NCT02442414|Drug|KBP-5209|Single oral dose beginning at 20 mg with daily dosing for 28 day cycles.
16061744|NCT02442401|Device|The negative pressure wound therapy|
16061745|NCT02442388|Procedure|Instrumentation technique with hand file|type of instrumentation technique for root canal treatment
16061746|NCT02442388|Procedure|Instrumentation technique with ProTaper|type of instrumentation technique for root canal treatment
16061747|NCT02442388|Procedure|Instrumentation technique with WaveOne|type of instrumentation technique for root canal treatment
16061748|NCT02442375|Radiation|standard dose prescription|"standard elective dose
~no intermediate dose-level
~visual interpretation of FDG-PET-scan"
16061749|NCT02442375|Radiation|FDG-PET guided gradient dose prescription|"de-escalation of elective dose
~intermediate dose-level
~standardized methods to evaluate FDG-PET-scan"
16061750|NCT02442362|Drug|paclitaxel+oxaliplatin+fluorouracil|"Patients treated with paclitaxel+oxaliplatin+fluorouracil: paclitaxel (135 mg/m2 iv) on day 1, oxaliplatin (100 mg/m2 iv) on day 1, fluorouracil (500 mg/m2 continuous iv) on day 1-5twice/day for body surface area between 1.25 and 1.50 m2 orally) on days 1-14."
16061751|NCT02442362|Drug|oxaliplatin+S1|"Patients treated with oxaliplatin+S1: oxaliplatin (130 mg/m2 iv) on day 1 and S-1 (40 mg twice/day for body surface area < 1.25 m2 and 60 mg twice/day for body surface area between 1.25 and 1.50 m2 orally) on days 1-14"
16061752|NCT02442349|Drug|AZD9291|Once daily tablet 80 mg
16061753|NCT02442336|Behavioral|My Journey AHead|The intervention program will contain information and interactive activities around swallowing concerns, proper oral care, healthy eating and nutrition, speech issues, stress and coping with cancer, and pain management.
16061754|NCT02442323|Behavioral|Walking Intervention|12-week walking program
16061755|NCT02442310|Drug|Deferiprone delayed release tablet formulation|Deferiprone 600 mg delayed release tablet formulation
16061756|NCT02442310|Drug|Deferiprone oral solution|Deferiprone 100 mg/mL oral solution
16061851|NCT02441673|Drug|Ephedrine|A vasopressor. Would be used to combat any hypotension that occurs due to the neuroaxial block. Would be used in aliquots of 3mg.
16063449|NCT02429596|Drug|Experimental|Switch from brand to generic
16061757|NCT02442297|Biological|HER2-specific T cells|"Dosing Schedule 1:
~Cycle 1 A: 1x10^7 cells
~Cycle 2 A: 1x10^7 cells
~Cycle 3 A: 1x10^7 cells
~Dosing Schedule 2:
~Cycle 1 A: 1x10^7 cells
~Cycle 2 B: 3x10^7 cells
~Cycle 3 B: 3x10^7 cells
~Dosing Schedule 3:
~Cycle 1 A: 1x10^7 cells
~Cycle 2 B: 3x10^7 cells
~Cycle 3 C: 1x10^8 cells
~Subsequent cycles*
~*Additional cycles may be administered at ≤ the final cell dose reached in cycle 3, provided that the subject continues to meet eligibility criteria and does not have confirmed progressive disease."
16061758|NCT02442284|Drug|ombitasvir/paritaprevir/ritonavir and dasabuvir|Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet
16061759|NCT02442284|Drug|Ribavirin|Tablet
16061760|NCT02442271|Drug|ombitasvir/paritaprevir/ritonavir and dasabuvir|Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet
16061761|NCT02442271|Drug|ribavirin|Tablet
16061762|NCT02442258|Drug|ABT-493|A single dose of ABT-493 will be given orally in combination with ABT-530.
16061763|NCT02442258|Drug|ABT-530|A single dose of ABT-530 will be given orally in combination with ABT-493.
16061764|NCT02442245|Dietary Supplement|XSurge|During part one of the study, 28 days of supplementation with XSurge will be provided. During the second part of the study 6 weeks of supplementation with XSurge will accompany a training program.
16061765|NCT02442245|Other|Placebo: Microcrystalline Cellulose|
16061766|NCT02442245|Other|Control: No supplementation|
16061767|NCT02442206|Drug|QVA149|QVA149 capsules 100/50 µg for inhalation via Concept-1-inhaler, taken once daily
16061768|NCT02442206|Drug|Placebo|Placebo to QVA140 capsules 100/50 µg for inhalation via Concept-1-inhaler, taken once daily
16061769|NCT02442193|Other|Individual Placement and Support|Individual Placement and Support is a form of supported employment.
16061770|NCT02442180|Drug|G-CSF (Filgrastim injection)|G-CSF (Filgrastim injection) 5ug/kg subcutaneous injection daily for 5 days and every 3 days (total 12 doses)
16061771|NCT02442180|Drug|steroid|oral prednisolone 40mg qd or iv methylprednisolone 32 mg if oral medication is not tolerable
16061772|NCT02442180|Drug|placebo|equivalent to G-CSF doses
16061773|NCT02442154|Procedure|Tracheostomy|It is a surgical procedure which involves making an incision on the anterior aspect of the neck and opening a direct airway through an incision in the trachea with stitching the trachea to the skin and placement of a tube
16061774|NCT02442128|Drug|propofol /Fentanyl|fentanyl 2 μg/kg and propofol 2 mg/kg Both test drugs will be made up to 10 ml with saline. fentanyl will be first administered intravenously over 30 s followed by propofol over 20 s.
16061775|NCT02442128|Drug|Fentanyl / propofol|fentanyl 2 μg/kg and propofol 3 mg/kg. Both test drugs will be made up to 10 ml with saline. fentanyl will be first administered intravenously over 30 s followed by propofol over 20 s.
16061776|NCT02442115|Other|Treatment of Functional Constipation by|The NASPGHAN protocol is used by pediatric gastroenterologist to treat functional constipation. Status is monitored at 4 visits and adjustments to treatment are made based on clinical standards and judgment.
16061777|NCT02442102|Behavioral|Exercise and sensory stimulation|60-minute sessions with sensory electrical stimulation (SES) applied 5 days per week with oromotor exercises completed when patient is able to participate
16061778|NCT02442089|Behavioral|Health Call|Health Call is an automated interactive voice reminder system that can contact guardians of patients ahead of their child's appointment, asks then confirms a security question about the patient, then, if the call recipient passes the security screen, provides a reminder about upcoming appointment.
16061779|NCT02442063|Drug|Radium Ra 223 dichloride (Xofigo, BAY88-8223)|50 kBq/kg intravenous injection once every 4 weeks, will be administrated from cycle 2 up to 6 cycles
16061780|NCT02442063|Drug|paclitaxel|90 mg/m2 intravenous injection per week in a 3-week-on / 1-week-off regimen, will be administered as per local standard of care, starting in cycle 1
16061781|NCT02442050|Other|del Nido solution|1.0-liter of del Nido Cardioplegia after the aortic cross-clamp is applied to the ascending aorta. Delivery of del Nido solution will be administered in a 1:4 ratio of blood:crystalloid at a temperature of 6-10 degrees centigrade.
16061782|NCT02442050|Other|Blood-based cardioplegia|An induction dose of whole blood cardioplegia ranging from 1.0-2.0 liters of solution will be given, with subsequent doses of cardioplegia every 20 minutes.
16061783|NCT02442037|Biological|UCMSC group|Human umbilical cord MSCs are transplanted three times by intravenous infusion(1×10^6/kg) ,once every week，a total of three times.
16061784|NCT02442037|Other|Control group(Normal saline)|Normal saline in same volume as MSCs are transplanted to patients.
16061785|NCT02442024|Behavioral|Modified Diet|Two months of a diet in which the ingestion of protein and lipid precedes that of carbohydrates.
16061786|NCT02442024|Behavioral|Standard Diet|Two months of a diet in which the ingestion of protein and lipid follows that of carbohydrates.
16061787|NCT02441998|Other|Education intervention: Training in Narrow Band Imaging|Two hour training session in interpretation and application of narrow band imaging technology
16061788|NCT02441985|Device|Magstim RapidStim2|Application of repetitious transcranial magnetic stimulation (TMS) pulses using Magstim RapidStim2 to a specific brain target at predefined stimulation parameters.
16061789|NCT02441985|Device|Sham Magstim RapidStim2|Same procedure as real rTMS without stimulating the cerebral cortex.
16061790|NCT02441985|Other|Fahn-Tolosa-Marin Tremor Rating Scale (TRS)|All participants will receive a clinical assessment of tremor severity by using the TRS test.
16061791|NCT02441985|Other|"Timed Up & Go Test (TUG) test"|All participants will receive a clinical assessment of basic mobility skills by using the TUG test.
16061792|NCT02441985|Other|10m walk test|All participants will receive a clinical assessment of walking speed by using the walk test.
16061793|NCT02441985|Other|Tremor electrophysiology|All participant tremors will by analyzed using an EMG system
16061794|NCT02441985|Other|Cerebellar-brain Inhibition (CBI)|All participants will have a measure of the cerebellar-brain inhibition(CBI) which will be conducted by using a TMS device determining the ability of the coil to activate the cerebellum.
16061795|NCT02441972|Drug|18F-Al-NOTA-PRGD2 PET/CT|18F-Al-NOTA-PRGD2(PET imaging agent) given by vein before PET scans.Perform PET/CT for each enrolled volunteer or patient at 60-90min.
16061796|NCT02441959|Procedure|Lumbar discectomy Open|Open Discectomy
16061797|NCT02441959|Procedure|Lumbar discectomy Endoscopic|Endoscopic Discectomy
16061798|NCT02441946|Drug|Abemaciclib|Administered orally
16061801|NCT02441933|Drug|taxane plus carboplatin|"Doxorubicin (60 mg/m2) IV + cyclophosphamide (600 mg/m2) IV every 3 weeks for 4 cycles followed by taxane plus carboplatin for 4 cycles The taxane plus carboplatin regimen can be selected based on the investigator's discretion from among the following two regimens.
~Docetaxel (75 mg/m2) IV plus carboplatin (AUC 5) IV every 3 weeks for 4 cycles
~Paclitaxel (80 mg/m2) IV weekly for 12 doses plus carboplatin (AUC 5) IV every 3 weeks for 4 cycles"
16061802|NCT02441933|Drug|Taxane|"Doxorubicin (60 mg/m2) IV + cyclophosphamide (600 mg/m2) IV every 3 weeks for 4 cycles followed by taxane for 4 cycles The taxane regimen can be selected at the investigator's discretion from among the following two regimens.
~Docetaxel (75 mg/m2) IV every 3 weeks for 4 cycles
~Paclitaxel (80 mg/m2) IV weekly for 12 doses"
16061803|NCT02441907|Drug|aflibercept|
16061804|NCT02441894|Drug|CABAZITAXEL XRP6258|Pharmaceutical form:solution Route of administration: intravenous
16061805|NCT02441894|Drug|PEG-G-CSF|Pharmaceutical form:solution Route of administration: subcutaneous
16061806|NCT02441894|Drug|Prednisolone|Pharmaceutical form:tablet Route of administration: oral
16061807|NCT02441894|Drug|Dexchlorpheniramine or Diphenhydramine|Pharmaceutical form:tablet, powder, or solution Route of administration: oral, intravenous or intramuscular
16061808|NCT02441894|Drug|Ranitidine|Pharmaceutical form:tablet or solution Route of administration: oral, intravenous or intramuscular
16061809|NCT02441894|Drug|Metoclopramide, Granisetron, or Ondansetron|Pharmaceutical form:tablet, powder, jelly, or solution Route of administration: oral, intravenous or intramuscular
16061810|NCT02441894|Drug|Dexamethasone|Pharmaceutical form:tablet, capsule, or solution Route of administration: oral or intravenous
16061811|NCT02441881|Device|Venefit|Endovenous radiofrequency device
16061812|NCT02441881|Device|Radiofrequency Induced Thermal Therapy|Endovenous radiofrequency device
16061813|NCT02441881|Device|Endovenous Radiofrequency|Endovenous radiofrequency device
16061814|NCT02441868|Behavioral|Shortness of breath recognition and treatment|Hospice registered nurses will train family caregivers about how to recognize patient shortness of breath. This training will employ a guided learning tool the Respiratory Distress Observation Scale-Family. Training will be done with a DVD and return demonstration of the skills using the patient. In addition, the family will be taught the bundle of evidence-based interventions to treat shortness of breath.
16061815|NCT02441855|Device|echocardiography|echocardiography: Left and right ventricular functions and aortic elastic properties.
16061816|NCT02441842|Drug|atenolol|administered 60 minutes pre procedure
16061817|NCT02441842|Drug|lisinopril|administered 60 minutes pre procedure
16061818|NCT02441842|Other|glucose|administered 60 minutes pre procedure
16061819|NCT02441829|Drug|Eleclazine|Eleclazine tablets administered orally in morning with food
16061820|NCT02441816|Drug|Aflibercept|
16061821|NCT02441816|Other|Extend Treatment|In year 2 of the study a treat and extend protocol will be applied, if a patient has signs of disease activity (eg macular fluid on SDOCT) they will be brought back at 8 weeks after the visit and given an intravitreous injection. They will then be reviewed 8 weeks post treatment for a further treatment with follow-up and treatment interval extended to 10 weeks if the disease is quiescent (if no macular fluid at the subsequent visit the patient could be extended to 12 weeks interval with treatment).
16061822|NCT02441803|Drug|Busulfan|Test dose Busulfan 32 mg/m2 given by vein on Day -8. Busulfan AUC 5,000 by vein on Days -6 to -3.
16061823|NCT02441803|Drug|Fludarabine|Fludarabine 10 mg/m2 by vein on Days -6 to -3.
16061824|NCT02441803|Drug|Clofarabine|"Salvage Chemotherapy Before Transplant: Clofarabine 15 mg/m2 by vein on Days 6 - 9.
~Stem Cell Transplant: Clofarabine 40 mg/m2 by vein on Days -6 to -3."
16061825|NCT02441803|Radiation|Total Body Irradiation (TBI)|Total body irradiation (TBI) delivered at 2Gy on Day -2.
16061826|NCT02441803|Drug|Thymoglobulin|Thymoglobulin 2.0 mg/Kg by vein on Days -3 and -2.
16061827|NCT02441803|Biological|Stem Cell Infusion|Fresh or cryopreserved bone marrow or peripheral blood (PB) progenitor cells infused on Day 0. Goal is to infuse 4 X 106 CD34+ cells/kg if PB or >3.0 X 108 marrow mononuclear cells/kg if bone marrow.
16061828|NCT02441803|Drug|Cyclophosphamide|Cyclophosphamide 50 mg/kg by vein on Days +3 and +4.
16061829|NCT02441803|Drug|Tacrolimus|Tacrolimus 0.015 mg/kg/day by vein or mouth on Day +5.
16061830|NCT02441803|Drug|Mycophenolate mofetil|Mycophenolate mofetil 15 mg/kg/dose by vein or by mouth three times a day from Day +5 to Day+100.
16061831|NCT02441803|Drug|Decitabine|20 mg/m2 by vein on Days 1 - 5.
16061832|NCT02441803|Drug|Cytarabine|1 g/m2 by vein on Days 6 - 10.
16061833|NCT02441803|Drug|Idarubicin|10 mg/m2 by vein on Days 6 - 8.
16061834|NCT02441790|Behavioral|Early Active Range of Motion|3-9 days
16061835|NCT02441790|Behavioral|Standard Immobilization|21-27 days
16061836|NCT02441777|Device|Polarization-Sensitive OFDI|OCT Imaging of the eye
16061837|NCT02441751|Procedure|intra-operative blood loss|surgery in the urology and orthopedics
16061838|NCT02441738|Procedure|Hybrid Ablation|The procedure will be performed following standard of care guidelines.
16061839|NCT02441738|Procedure|Catheter Ablation|The procedure will be performed following standard of care guidelines.
16061840|NCT02441725|Other|1-minute sit-to-stand test|Validation of the 1-minute sit-to-stand test in a COPD patient population
16061841|NCT02441712|Device|PENS|
16061842|NCT02441699|Behavioral|Improved water supply and sanitation|Village-level reticulated water supply with distribution to household taps; pour-flush pit latrines.
16061843|NCT02441686|Drug|Bortezomib|
16061844|NCT02441686|Drug|Lenalidomide|
16061845|NCT02441686|Drug|Dexamethasone|
16061846|NCT02441673|Drug|Nefopam|Nefopam 0.15mg/kg would be made up to 10mls using sterile water for injection
16061847|NCT02441673|Drug|Tramadol|Tramadol 1mg/kg would be made up to 10mls using sterile water for injection
16061848|NCT02441673|Drug|Metoclopramide|10mg would be given morning of surgery as a prokinetic premedication for all patients.
16061849|NCT02441673|Drug|Ranitidine|50mg would be given to each patient morning of surgery as a premedicant to reduce the acidity of the gastric contents. It is routine for CS.
16061850|NCT02441673|Drug|Pethidine|25mg would be used to stop shivering where a repeat dose of the primary intervention drugs have not been effective.
16061852|NCT02441673|Drug|oxytocin|Would be used for all patients following delivery of the baby to aid contraction of the uterus.
16061853|NCT02441660|Drug|Capsaicin 8% Patch|Applied topically for 1 hour
16061854|NCT02441660|Drug|Low Dose Capsaicin 0.04% gel|
16061855|NCT02441647|Device|KL029 Intimate Lubricant Gel|
16061856|NCT02441621|Other|passive leg raising|The passive leg raising maneuver (PLR) involves a leg elevation up to 45° with the trunk in a horizontal position and is performed to induce hemodynamic effects by a volume challenge, turning unstressed blood volume to stressed volume proportional to body size.
16061857|NCT02441621|Other|premedication|patients receive premedication with midazolam 7.5 mg p.o.
16061858|NCT02441621|Other|intubation and mechanical ventilation|After induction of anesthesia with sufentanil (0.5 µg/kg) and propofol (1.5 mg/kg), orotracheal intubation is facilitated with rocuronium (0.6 mg/kg). Anesthesia is maintained with sufentanil (1 µg/kg/h) and propofol (3 mg/kg/h) and patients are ventilated with an oxygen/air mixture in volume-controlled mode, using a tidal volume of 8 ml/kg related to the ideal body weight. Positive end-expiratory pressure is set at 5 cmH2O.
16061859|NCT02441621|Other|central venous catheter|a central venous catheter in the right or left internal jugular vein.
16061860|NCT02441621|Other|arterial catheter|Continuous monitoring is performed including electrocardiogram, radial arterial pressure catheter
16061861|NCT02441621|Other|transesophageal echocardiography|Before placement of a transpulmonary thermodilution catheter a transesophageal echocardiography (TOE) is performed. TOE is used to detect diastolic dysfunction of the left ventricle and to exclude right ventricular dysfunction.
16061862|NCT02441621|Other|transpulmonary thermodilution catheter|In presence of left ventricular dysfunction a transpulmonary thermodilution catheter is placed in the femoral artery and connected to a PiCCO2 monitor (PiCCO2, Pulsion Medical Systems, Munich, Germany).
16061863|NCT02441608|Device|KL029 Intimate Lubricant Gel|All the volunteers will receive the application of four dressings (3 placebos and 1 containing the tested product). After a certain period of time, photoirritation and photosensitization will be measured through the evaluation of tested region.
16061864|NCT02441595|Behavioral|MBCP|Eight weekly sessions 2,5 h and homework 30 min/day. Practicing various mindfulness meditations coupled with practical skills and theory of birthing and parenting.
16061865|NCT02441595|Behavioral|Psychoprophylaxis|Three sessions 3h each, and practices to do at home. Practical skills of relaxation and breathing techniques for labor as well as knowledge of birthing and parenting.
16061866|NCT02441582|Other|Telemetry|
16061867|NCT02441582|Other|Non-telemetry|
16061868|NCT02441569|Behavioral|Common factors engagement training for provider|Primary care providers have received brief training in communication skills designed to promote family engagement in care including understanding of treatment and empowerment.
16061869|NCT02441569|Behavioral|Standard pediatric advice for childhood anxiety|Providers will be free to use their existing knowledge of anxiety problems to offer routine counseling.
16061870|NCT02441556|Device|endovascular treatment|The endovascular treatment is comprised of thrombolysis, mechanical thrombectomy, stenting, or a combination of all these approaches. Generally, Solitaire FR is preferred, other devices such as Trevo or future advanced devices can also be considered which will be decided by the executive committee.
16061871|NCT02441556|Other|standard medical therapy|If the patient meets the criteria for IV rt-PA within 4.5 h of stroke onset, he/she will receive a single alteplase dose of 0.9 mg/kg IV(maximum dose: 90mg), with 10% given as a bolus, followed by continuous IV infusion of the other dose within 1h. All patients will receive standard medical therapy. The standard medical therapy conforms with the current American Heart Association/American Stroke Association guidelines.
16061872|NCT02441530|Dietary Supplement|Vitamin D|
16061873|NCT02441530|Dietary Supplement|Vitamin E|
16061874|NCT02441530|Drug|Ibuprofen|
16061875|NCT02441517|Drug|Enzalutamide|Participants were administered four 40-mg capsules orally once daily and taken as close to the same time each day as possible and could be taken with or without food.
16061876|NCT02441504|Other|Low intensity Exercise|aerobic exercise training using walking and running
16061877|NCT02441491|Drug|Cyclophosphamide|"Cyclophosphamide will be given by vein once a day for four straight days.
~Ten days after starting cyclophosphamide, filgrastim, a drug that helps normal blood cells to grow, by vein once every day to try to help your blood cells grow faster."
16061878|NCT02441478|Radiation|functional magnetic resonance imaging exam|
16061879|NCT02441465|Drug|Vemurafenib|Oral vemurafenib will be administered at a dose of 960 milligrams BID from Day 1 to Day 28.
16061880|NCT02441465|Drug|14C-Labeled Vemurafenib|IV infusion of 18.5 kilobecquerel (kBq) of 14C-labeled vemurafenib (3 milliliters [mL], which corresponds to a dose of 20 micrograms [mcg] of vemurafenib) on Day 21 (immediately after the morning oral dose of vemurafenib).
16061881|NCT02441452|Other|Early rehabilitation|The physical exercises and breathing exercises are started as soon as after the Nuss procedure
16061882|NCT02441439|Dietary Supplement|Iron sucrose 200 mg|I.V Iron sucrose 200 mg 2-3 times per week. Each time for 20-30 minutes
16061883|NCT02441439|Dietary Supplement|Iron sucrose 500 mg|I.V Iron sucrose 500 mg once per week. Each time for 3.5 hours
16061884|NCT02441413|Radiation|High Resolution Computed Tomography scans|"A HRCT scan at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) will be taken on visit 1, visit 2, visit 3, visit 4 and visit 5.
~An Upper Airway (UA) scan will be taken on visit 1."
16061885|NCT02441400|Device|EndoStim LES Stimulation System|
16061886|NCT02441387|Drug|Antidepressant|Sertraline 50-250mg/day for 1 year or Escitalopram 10-20mg/day for 1 year or Mirtazapine 15-45mg/day for 1 year or Venlafaxine 37,5-300mg/day for 1 year or Lithium 300-900mg/day for 1 year.
16061887|NCT02441387|Other|Psychoeducation|Patients who are in the antidepressant treatment group and does not reach remission (MADRS score <or =8) until visit 4 will be invited to be part of a psychoeducation program. If the patient accepts the psychoeducation intervention, he will be randomized to psychoeducation (pharmacological treatment plus psychoeducation) or treatment as usual (only pharmacological treatment). The psychoeducation program consists of 10 individual sessions, conducted by a trained psychologist who will explain the main concepts of depression and its symptoms, the importance of adhering to treatment, the main side effects of pharmacological treatment, and how to cope with daily difficulties.
16062601|NCT02436031|Drug|Placebo|Placebo-matching desipramine administered 2 hours before normal sleep time
16061888|NCT02441387|Other|Treatment as usual (only pharmacological treatment).|Patients who are in the antidepressant treatment group and does not reach remission (MADRS score <or =8) until visit 4 will be invited to be part of a psychoeducation program. If the patient accepts the psychoeducation intervention, he will be randomized to psychoeducation (pharmacological treatment plus psychoeducation) or treatment as usual (only pharmacological treatment).
16061889|NCT02441374|Device|Tubular mesh.|Rehabilitation in upper limb during and after applying of FUT (through the tubular mesh) post stroke.
16061890|NCT02441374|Other|Classical kinesiotherapy.|Applying classical kinesiotherapy in upper limb post stroke.
16061891|NCT02441361|Other|Exercise training|Exercise training will comprise aerobic and strength exercises
16061892|NCT02441348|Behavioral|Conversation Training Therapy|Conversational speech as the primary focus of voice therapy in individuals with muscle tension dysphonia or vocal fold lesions.
16061893|NCT02441322|Device|Novo-TTF|Procedures: MRI and advanced MRI sequence Advanced brain MRI's with special sequences will be obtained. First MRI prior to starting Novo-TTF therapy, second MRI up to 2-3 weeks after beginning therapy, third MRI up to 2 months from starting treatment and the last MRI up to 4 months after starting treatment.
16061894|NCT02441309|Drug|Mifamurtide|
16061895|NCT02441309|Drug|Ifosfamide|
16061896|NCT02441296|Other|Formula with lactose|
16061897|NCT02441296|Other|Formula with maltodextrins|
16061898|NCT02441283|Drug|ABT-493|ABT-493 was not administered in this study. This study was a follow-up for participants who received the drug in prior studies.
16061899|NCT02441283|Drug|ABT-530|ABT-530 was not administered in this study. This study was a follow-up for participants who received the drug in prior studies.
16061900|NCT02441270|Drug|Cyclophosphamide|
16061901|NCT02441270|Radiation|Stereotactic body radiotherapy|
16061902|NCT02441257|Procedure|control ventilation|patients are randomly divided to receive control or spontaneous ventilation randomly.
16061903|NCT02441257|Procedure|spontaneous ventilation|patients are randomly divided to receive control or spontaneous ventilation randomly.
16061904|NCT02441244|Drug|Visbiome|Visbiome probiotic
16061905|NCT02441244|Other|Placebo|Placebo
16061906|NCT02441231|Drug|Visbiome|Visbiome probiotic
16061907|NCT02441231|Other|Placebo|Placebo
16061908|NCT02441218|Drug|Ivabradine|2.5mg, 5mg or 7.5mg tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
16061909|NCT02441218|Drug|Placebo|Matching placebo tablets to be taken orally twice daily, at 12-hours intervals, in the morning and in the evening during meals up to 42 months.
16061910|NCT02441205|Behavioral|High Intensity Interval training|all subjects will undergo high intensity interval training 3 x per week for 10-12 weeks. the intervals of high-intensity (~85% of maximal capacity) will be 5 to 10 bouts of 30 seconds at this intensity with rest periods in between intervals that range from 30 seconds to 2 minutes
16061911|NCT02441192|Other|Training resistance|After the baseline tests they were distributed in four randomized groups for the 6 weeks of training: aerobic (AT), resistance (RT), aerobic+resistance (AT+RT) and control (C).
16061912|NCT02441192|Other|Training aerobic|After the baseline tests they were distributed in four randomized groups for the 6 weeks of training: aerobic (AT), resistance (RT), aerobic+resistance (AT+RT) and control (C).
16061913|NCT02441192|Other|Training resistance+aerobic|After the baseline tests they were distributed in four randomized groups for the 6 weeks of training: aerobic (AT), resistance (RT), aerobic+resistance (AT+RT) and control (C).
16061914|NCT02441179|Other|Acute Intermittent Hypoxia|Patients will breath 9% oxigen for 1.5 minutes interspersed with 1.5 minutes of 21% oxigen (normoxia), 15 times for a total of 45 minutes.
16061915|NCT02441179|Other|Body weight-assisted treadmill training|Patient´s gait will be trained through a weight-assisted treadmill (BWSTT). All recruited patients will start BWSTT at a speed of 0.6 km/hr. The physical therapist will manually correct posture to assure an adequate gait, increasing the speed of treadmill progressively depending upon the patient progress and tolerance. This training will be done immediately after the protocol of AIH or Sham and it will last 45 minutes.
16061916|NCT02441179|Other|Sham Protocol|It consists of continuous normoxia (FiO2=0.21) for 45 minutes for 5 consecutive days and then 3 times per week for 3 weeks. Total time: 4 weeks.
16061917|NCT02441166|Procedure|Mastocytosis diagnosis|Some samples will be extracted from bone marrow aspirate and peripheral blood on the inclusion day to do diagnosis tests. WHO criteria will be used as the reference standard.
16061918|NCT02441153|Other|Extended Timing|Surgery will be performed at 10-11 weeks after completion of chemoradiotherapy.
16061919|NCT02441140|Procedure|Culdocentesis|A sterile speculum will be placed in the vagina and the cervix identified. The cervix will be elevated using a tenaculum and a spinal needle inserted through the posterior vaginal fornix. Fluid from the posterior cul de sac will be collected
16061920|NCT02441140|Procedure|Vaginal Swab|. A sterile speculum will be placed in the vagina and a Pap smear spatula will be used to swab the posterior fornix of the vagina. This swab will then be rinsed in a tube of saline.
16061921|NCT02441140|Procedure|Chromopertubation|Chromopertubation is a common gynecologic technique used to test the patency of fallopian tubes during infertility evaluations. Fluid is flushed through the cervix and uterus and out the fallopian tubes.
16061922|NCT02441140|Procedure|Blood collection|Intravenous blood collection will be drawn from an IV
16061923|NCT02441140|Procedure|Tissue collection|As part of the standard surgical procedure for presumed ovarian cancer, the primary tumor will be resected and a sample obtained for evaluation
16061924|NCT02441127|Device|diode laser group|the laser tip was used to remove all visible epithelium in the outer side of the defined graft area. The treatment was performed from the coronal to the apical aspect in parallel paths, and care was taken to avoid any laser contact to the palatal bone and periosteum by aiming the laser beam at a 450 angle to the palatal soft-tissue. The resultant layer on the surface was totally removed with knife and moist gauze. Then, the graft was harvested from the de-epithelized area with a 15c blade.
16061953|NCT02440906|Behavioral|Patient-Directed Wellness Account|The intervention group (n=629) continue to receive usual care and receive a financial incentive to use in meeting their health goals.
16062000|NCT02440568|Drug|Omacetaxine mepesuccinate|Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Dose level 2.0mg/m^2
16061925|NCT02441127|Procedure|scalpel control group|In the control group tissue was obtained by two horizontal and two vertical incisions defining the area to be harvested. The blade was oriented perpendicular to the bone along the coronal horizontal incision and once an adequate soft tissue thickness was obtained; it was rotated in order to be parallel to the superficial surface. The thickness of the graft was maintained uniform while proceeding apically with the blade until the FGG was harvested. The palatal wound was protected with equine-derived collagen maintained by compressive sling 5-0 sutures
16061926|NCT02441114|Drug|HCP0910 and HGP1011|Inhalation of HCP0910 (Seretide 250 diskus (Fluticasone Propionate 250 mcg/Salmeterol Xinafoate 72.5 mcg)) and HGP1011 (Spiriva capsule for inhalation (Micronized Tiotropium Bromide Monohydrate 22.5 mcg))
16061927|NCT02441101|Device|RV DDD(R)-60 with AV optimization|Device to be programmed for RV pacing with AV interval optimization at the bedside to produce QRS fusion with the native conduction down the native left bundle on surface EKG
16061928|NCT02441101|Device|RV DDD(R)-60|AV settings programmed to minimize RV pacing - standard demand pacing programming.
16061929|NCT02441088|Drug|90Y-DOTA-tyr3-Octreotide|90Y-DOTATOC is a radiopharmaceutical that will be used in this a dosimetry-guided theranostics trial for both children and adults with neuroendocrine and other somatostatin receptor positive tumors. Each subject will receive three doses of 90Y-DOTATOC.
16061930|NCT02441088|Radiation|Dosimetry-Guided Peptide Receptor Radiotherapy|90Y-DOTATOC delivers radiation to rumor cells that express somatostatin receptors.The dose of 90Y-DOTATOC administered in this dosimetry-guided theranostics trial will be determined by dosimetry that estimates the amount of radiation delivered to the kidneys during treatments one and two.
16061931|NCT02441088|Drug|Aminosyn II|Aminosyn II is a solution of amino acids that will decrease the amount of 90Y-DOTATOC that recirculates through the body after injection, therefore decreasing radiation dose to the kidneys.
16061932|NCT02441075|Other|70% Ethanol|the study will use 70% ethanol lock in the CVLs. A 2ml 70% ethanol lock will be instilled into the white lumen of the CVL for 2 hours. At the end of 2 hours, the ethanol will be withdrawn; the CVL lumen flushed with normal saline, and the CVL would be available for normal use for that day.
16061933|NCT02441062|Drug|68Ga-DOTATOC PET/CT|Ga-68 DOTATOC PET-CT on management of patients with somatostatin receptor positive tumors
16061934|NCT02441049|Behavioral|Home-based promotora family intervention|A promotora-delivered family intervention in the participant's home. Promotoras used a telenovela-style DVD and accompanying manual to deliver 11 home sessions to the family, and 4 support telephone calls, over a 4 month period.
16061935|NCT02441036|Device|Ultherapy Treatment|Focused ultrasound energy delivered below the surface of the skin.
16061936|NCT02441023|Behavioral|Nutritional therapy and education|"Nutritional therapy guidance according to sex, age, weight and comorbidity present. The recommendations of calories and macronutrients intake were indicated according to the Official Mexican Standards for Diabetes treatment and the American Diabetes Association standards for medical care in diabetes.
~Education with multimedia application: Patients were exposed to the multimedia application previous to the nutritional counseling. Multimedia application comprises the following modules: 1) Introduction, 2) Nutrition, 3) Physical Exercise, 4) Diabetes myths 5) Metabolic control indicators 6) Knowing diabetes, 7) Diabetes complications including testimonials."
16061937|NCT02441023|Behavioral|Nutritional therapy|Nutritional therapy guidance according to sex, age, weight and comorbidity present. The recommendations of calories and macronutrients intake were indicated according to the Official Mexican Standards for Diabetes treatment and the American Diabetes Association Standards for medical care in diabetes.
16061938|NCT02441010|Device|meridian therapy instrument|The meridian therapy instrument are widely used to improve the physical and relieve fatigue and pain in many hospitals by the field-effect.
16061939|NCT02441010|Other|health information push technology|The health information push technology regularly send health information on the measurements of body weight control and the improvement of a healthy lifestyle.
16061940|NCT02441010|Device|monitoring device|The monitoring device is used to monitor a person's blood pressure, blood glucose, oxygen saturation, body weight, and energy consumption by Bluetooth Wireless technology.
16061941|NCT02440997|Other|aromatherapy|
16061942|NCT02440997|Other|foot bath|
16061943|NCT02440984|Procedure|Colonic biopsies during endoscopy|eligible patients will have physical examination, colonic biopsies during endoscopy and anal manometry with barostat. these investigations are part of the usual healthcare. Colonic biopsies will be used to study intestinal permeability, colonic inflammation and enteric nervous system.
16061944|NCT02440971|Device|S9-Autoset CS-A|The S9-Autoset CS-A is an adaptive servo-ventilation (ASV) machine. It adjusts the level of inspiratory support automatically in response to the patient's respiratory effort. Inspiratory support is increased in the presence of hypoventilation and decreased in the presence of hyperventilation.
16061945|NCT02440958|Drug|modified FOLFIRINOX regimen|Modified FOLFIRINOX regimen consisted of oxaliplatin at a dose of 60 mg per square meter, given as a 2-hour intravenous infusion, after 60 minutes, of irinotecan at a dose of 120 mg per square meter, given as a 90-minute intravenous infusion, immediately followed by leucovorin at a dose of 400 mg per square meter, given as a 2-hour intravenous infusion through a Y-connector. This treatment was immediately followed by fluorouracil at a dose of 400 mg per square meter, administered by intravenous bolus, followed by a continuous intravenous infusion of 2400 mg per square meter over a 46-hour period every 2 weeks
16061946|NCT02440945|Device|Collection of blood|Blood test on blotting paper DBS (for the patients recruting)
16061947|NCT02440932|Dietary Supplement|Phenylketonuria-type diet|Breakfast, lunch and open buffet dinner
16061948|NCT02440932|Other|Normal (control) diet|Breakfast, lunch and open buffet dinner
16061949|NCT02440919|Other|Hyperoxygenation 100% FiO2|Endotracheal suction associated with Hyperoxygenation involved supplying 100% oxygen.
16061950|NCT02440919|Other|Hyperoxygenation 20% FiO2|Endotracheal suction associated with Hyperoxygenation involved supplying 20% oxygen above FiO2 basal.
16061951|NCT02440919|Other|Hyperinflation (PEEP- ZEEP) Basal FiO2|Endotracheal suction associated ventilator hyperinflation (PEEP-ZEEP maneuver) and involved no hyperoxygenation, keeping the oxygen already offered to the patient.
16061952|NCT02440919|Other|Hyperinflation (PEEP- ZEEP) 20% FiO2|Endotracheal suction associated ventilator hyperinflation (PEEP-ZEEP maneuver) and hyperoxygenation involved supplying 20% oxygen.
16062642|NCT02435732|Drug|Heparin|Added to the one of the arms receiving 200U/kg dose of CINRYZE
16061954|NCT02440906|Behavioral|Health Navigator|The intervention group (n=629) will work with a health navigator on a monthly basis to develop and refine patient-centered health goals. Motivational interviewing techniques are used to establish the wellness goals.
16061955|NCT02440893|Diagnostic Test|Corus CAD (ASGES)|
16061956|NCT02440880|Drug|Dexamethasone in addition to TAP block in dose of 4 mg|Dexamethasone in addition to TAP block in dose of 4 mg
16061957|NCT02440880|Drug|Dexamethasone in combination with TAP block in dose of 8 mg|Dexamethasone in combination with TAP block in dose of 8 mg
16061958|NCT02440880|Drug|Dexamethasone intravenous 4mg+ TAP block|Dexamethasone intravenous in addition to TAP block in dose of 4 mg
16061959|NCT02440880|Drug|Dexamethasone intravenous in addition to TAP block in dose of 8 mg|Dexamethasone intravenous + TAP block in dose of 8 mg
16061960|NCT02440880|Other|control|TAP block without Dexamethasone neither intravenous nor in combination with the block
16061961|NCT02440867|Device|Active TBS|Non-invasive transcranial magnetic stimulation inducing changes in cortical excitability depending on the cortical target (except for sham stimulation)
16061962|NCT02440867|Device|Sham TBS|Sham stimulation
16061963|NCT02440841|Drug|fedovapagon|
16061964|NCT02440841|Drug|Itraconazole|
16061965|NCT02440841|Drug|rifampicin|
16061966|NCT02440828|Drug|tobramycin inhalation|tobramycin inhalation 300 mg twice daily
16061967|NCT02440828|Drug|placebo|NaCl 0.9% inhalation 4 ml twice daily
16061968|NCT02440815|Behavioral|Problem Solving Therapy|Problem Solving Therapy (PST) is a brief evidence based psychotherapy that is commonly utilized for treatment of LLD. The problem solving therapy includes 12 weekly in person 50 minute sessions.
16061969|NCT02440802|Genetic|Saliva sample collection for genetic analyses|Patients with Prostate cancer receiving androgen deprivation treatment with a GnRH antagonist will be followed-up for 6 months for quality of life. At Baseline, 3 months and 6 months of treatment QoL data will be collected, as well as body parameters. At Baseline, once, a saliva sample will be collected for genetic analyses.
16061970|NCT02440789|Drug|Sirolimus|"Participants on a non-protease inhibitor (PI), non-non-nucleoside reverse transcriptase inhibitor (NNRTI) regimen, and for those on a non-PI, rilpivirine (RPV) based regimen received 0.025 mg/kg/day initial dose for 20 weeks.
~Participants on an NNRTI regimen with the exception of RPV received 0.05 mg/kg/day initial dose for 20 weeks."
16061971|NCT02440750|Procedure|operative hysteroscopy|Performed under general or local anesthesia, antibioprophylaxis may be administered. Cervical dilatation, will be made in order to introduce the hysteroscope. Operative hysteroscope used will include a handle. The distension of the uterine cavity will be performed with physiological saline or glycocoll, depending on the polarity of the high frequency generator necessary for resection system (monopolar or bipolar), with a pressure of maximum irrigation of 110 mm Hg.
16061972|NCT02440750|Drug|Dienogest|21 days administration of dienogest 2 mg/die
16061973|NCT02440750|Drug|Ulipristal acetate|21 days administration of ulipristal acetate 5 mg/die
16061974|NCT02440737|Other|Educational Intervention|"Receive publication, When Someone You Love is Being Treated for Cancer, a preliminary individualized Survivorship Care Plan (SCP), a final individualized SCP, and the REACH for Survivorship handbook."
16061975|NCT02440737|Other|Follow-Up Care|Complete Survivorship Care Planning session at end of treatment
16061976|NCT02440737|Procedure|Psychosocial Assessment and Care|Undergo the NEST intervention
16061977|NCT02440737|Other|Questionnaire Administration|Ancillary studies
16061978|NCT02440724|Device|Winged stent (partially covered)|A winged stent is a newly designed self-expandable metal stents(SEMS). Partially covered, or uncovered winged stent will be placed via the endoscopic intervention for malignant gastric outlet obstruction.
16061979|NCT02440724|Device|Winged stent (uncovered)|A winged stent is a newly designed self-expandable metal stents(SEMS). Partially covered, or uncovered winged stent will be placed via the endoscopic intervention for malignant gastric outlet obstruction.
16061980|NCT02440711|Device|Energy storing foot (ESF)|A commercially-available energy storing prosthetic foot
16061981|NCT02440711|Device|Modified running specific foot (mRSF)|A running specific prosthetic foot customized for both running and walking activities
16061982|NCT02440698|Behavioral|Genetic test for personalized nutrition|
16061983|NCT02440685|Drug|ASN002 Dose Escalation|Multiple ascending doses of ASN002 assigned by cohort
16061984|NCT02440685|Drug|ASN002 RD|Recommended dose of ASN002 from Part A
16061985|NCT02440672|Device|JOURNEY™ II CR Total Knee System (J II CR TKS)|TKA with Journey II CR Total Knee System
16061986|NCT02440646|Radiation|Coronary computed tomography angiography|The coronary arteries will be visualized with the MSCT scan CT 5000 Ingenuity (Philips, The Netherlands) or systems from any other vendors.
16061987|NCT02440646|Radiation|Quantitative coronary angiography, intravascular imaging with percutaneous intervention|Coronaries will be shot with Artis zee (Siemens, Germany) or systems from any other vendors. In case if necessary the procedure will be delayed for intravascular imaging (FFR, QFR, OCT, IVUS, VH-IVUS) and/ or percutaneous intervention (with implantation of the medical device).
16061988|NCT02440633|Drug|14C-OPS-2071|Subjects will swallow Single 25 mL of suspension containing 50 mg of 14C-OPS-2071 directly.
16061989|NCT02440607|Other|Electronic Cognitive Aid|
16061990|NCT02440607|Other|Static Cognitive Aid|
16061991|NCT02440594|Behavioral|Enhanced BHL Program Services|Patients or their caregivers will work with a BHP to provided additional support and education beyond the services received in the Standard BHL Program.
16061992|NCT02440594|Behavioral|Standard BHL Program Services|Patients or their caregivers receive a baseline clinical assessment as well as monitoring of symptoms and referral to community resources.
16061993|NCT02440581|Drug|Alendronate|
16061994|NCT02440581|Drug|Teriparatide|
16061995|NCT02440581|Drug|Cinacalcet|
16061996|NCT02440568|Drug|Cytarabine|Cytarabine (100mg/m^2/day) in 1000ml NS as a continuous IV infusion over 24 hours x 7 days.
16061997|NCT02440568|Drug|Idarubicin|Idarubicin (12 mg/m^2/day) IVPB in 100 mL NS over 15 minutes daily from Days 1 to 3.
16061998|NCT02440568|Drug|Omacetaxine mepesuccinate|Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Dose level 0.625mg/m^2
16061999|NCT02440568|Drug|Omacetaxine mepesuccinate|Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Dose level 1.25mg/m^2
16062001|NCT02440568|Drug|Omacetaxine mepesuccinate|Omacetaxine administered subcutaneously Q12 hours Days 1 to 7. Dose level 3.0mg/m^2
16062002|NCT02440555|Other|fulfill the self-administered questionnaire|Patients viewed in a pharmacy or a hospital fulfill the self-administered questionnaire before having a capillary blood glucose measurement.
16062003|NCT02440542|Other|Survey of outcomes following popliteal nerve block|Patients will be instructed to complete journals of pain and narcotic use until postoperative day 10. On first follow-up visit, patients will complete a patient satisfaction survey. VAS Pain scores and pain medication use will be collected up to 12 weeks postoperatively.
16062004|NCT02440529|Behavioral|Intervention|Discussion
16062005|NCT02440529|Behavioral|Verbal Group|Detailed Discussion
16062006|NCT02440516|Other|Early treatment group|Physical- and occupational Therapy
16062007|NCT02440516|Other|Late treatment group|Waiting list - then Physical- and occupational Therapy
16062008|NCT02440490|Behavioral|Computerised cognitive training|
16062009|NCT02440490|Behavioral|Video watching|
16062010|NCT02440477|Other|clinical shoulder tests|Three clinical shoulder tests (Neer impingement sign,Hawkins-kennedy, empty can) performed in three different sitting positions: normal resting posture, slouched posture, and upright posture with scapular retraction and shoulder. and in addition shoulder muscle strength test with handheld dynamometer
16062011|NCT02440464|Procedure|Allogeneic HSCT|Eligible patients with a Human Leukocyte Antigen (HLA)-matched related or unrelated donor will undergo allogeneic hematopoietic stem cell transplant at Day 0. For GVHD prophylaxis, patients will be given Tacrolimus from Day -3 until at least 6 months following initiation, at an intravenous daily dose of 0.015 mg/kg. This will be combined with an intravenous administration of Methotrexate at 5 mg/m2 on Days +1, +3, +6, and +11.
16062012|NCT02440464|Drug|Fludarabine|Patients will receive conditioning treatment before and after HSCT. Fludarabine will be given at 30 mg/m2 intravenously on Day -6 through Day -3.
16062013|NCT02440464|Drug|Melphalan|Melphalan will be given at 70 mg/m2 intravenously on Days -4 and -3.
16062014|NCT02440464|Drug|Bortezomib|Bortezomib will be administered at 1.3 mg/m2 intravenously on Day -3.
16062015|NCT02440464|Drug|Ixazomib|Between 60 and 120 days following HSCT, patients randomized to the experimental arm will receive Ixazomib maintenance. Maintenance will begin at 3-mg oral doses on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule, following successful completion of 3 cycles at the previous dosage, for a total of 12 cycles.
16062016|NCT02440464|Drug|Placebo|Between 60 and 120 days following HSCT, patients randomized to the control group will be given 3 mg of placebo orally on Days 1, 8, and 15 of a 28-day cycle. This will increase to 4-mg doses on the same cycle schedule following successful completion of 3 cycles of placebo maintenance at the 3-mg dose. This will continue for a total of 12 cycles.
16062017|NCT02440451|Device|Neurofeedback using BCI|This group will undergo five sessions of neurofeedback intervention in the fMRI scanner. Each subject will also undergo neuropsychological evaluations before the first neurofeedback session (week 0) and after the last neurofeedback session (week 7). The first four sessions are weekly while the last one is one month later. The intervention will take a total of four months. Follow up will be performed in the the first week and 6 months after the last intervention session.
16062018|NCT02440438|Biological|Blood sampling|Blood samples of 10 mL will be performed every 2 days from the first symptoms of CDI and until clinical recovery and/or hospital discharge
16062019|NCT02440425|Drug|Pembrolizumab|Pembrolizumab: 200 mg, every (Q) 3 weeks, via intravenous (IV) infusion, until progression or toxicity (or up to 24 months). The first cycle will begin on day 8.
16062020|NCT02440425|Drug|Paclitaxel|Paclitaxel: 80 mg/m^2, Q week for 3 weeks, via IV infusion, until progression or toxicity (or complete response if at least 6 cycles, at the discretion of the investigator and participant). Cycle 1 will have an extra lead in week (4 weeks total) with Paclitaxel only on week 1.
16062021|NCT02440412|Other|Massage Therapy|It's a Physical Therapy manual procedure, based in Swedish technique, and applied in a standirzed way for all participants (stroke, kneading, pressure).
16062022|NCT02440412|Other|Rest in supine|It's only rest, in a clinic stretcher, with warm ambient temperature, and listening relaxing music with headphones.
16062023|NCT02440399|Drug|Tramadol hydrochloride|Please see arm description
16062024|NCT02440399|Drug|Morphine|Please see arm description
16062025|NCT02440399|Drug|Paracetamol|
16062026|NCT02440399|Drug|Diclofenac|
16062027|NCT02440399|Drug|TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG)|
16062028|NCT02440386|Behavioral|Conditional economic incentive|"Individuals in the intervention arm will receive the standard of care. In addition, individuals in the intervention arm receive a voucher worth R300. They are told that they will get this money if they:
~Initiate ART at any clinic within 3 months from the time of their CD4 count test at the Tutu Tester; and
~send a text message to the study team to let us know they have started ART;
~Schedule a meeting with a member of the study team to show their clinic card and ARVs to confirm ART initiation."
16062029|NCT02440360|Behavioral|PSH|Please see arm description.
16062030|NCT02440360|Behavioral|Usual Care|Please see arm description.
16062031|NCT02440347|Device|Computer controlled anesthetic delivery by Anaeject|Single dose of 0.6ml 4% articaine with epinephrine (1:100.000) delivered by computer controlled local anesthetic delivery system (Anaeject).
16062032|NCT02440347|Device|Conventional anesthetic delivery by carpule syringe|Single dose of 0.6ml 4% articaine with epinephrine (1:100.000) delivered by conventional syringe (carpule syringe).
16062033|NCT02440334|Drug|Optison|Optison is an ultrasound contrast agent. The agent is a blood pooling agent administered via catheter and provides improved ultrasound visualization of the vasculature.
16062034|NCT02440321|Behavioral|Parent-child interactive program|
16062035|NCT02440321|Other|written materials|
16062036|NCT02440308|Drug|68Ga-DOTA-Bombesin|"68Ga-DOTA-Bombesin is a gallium-68-labeled gastrin-releasing peptide receptor (GRPr) antagonist. DOTA is [4,7,10-Tris-(carboxymethyl)-1,4,7,10-tetraazacyclododec-1-yl]-acetyl.
~68Ga-DOTA-Bombesin is administered intravenously (IV)"
16062037|NCT02440308|Procedure|Magnetic Resonance Imaging (MRI) scan|
16062038|NCT02440308|Procedure|Positron Emission Tomography (PET) scan|
16062039|NCT02440295|Procedure|Lower Extremity Amputation|
16062643|NCT02435732|Drug|CINRYZE|200U/kg IV dose with or without heparin, or 500U/kg IV dose
16062040|NCT02440295|Device|SPY Elite Imaging System|The SPY Elite Imaging System is an adjunctive tool that can be used to assess tissue perfusion in real-time and provides surgeons with information that may change their operative plan before leaving the operating room. (http://novadaq.com/products/spy-elite) The system is comprised of two components, the first is the Spy Elite Kit, which is a single-use package containing one 25 mg vial of indocyanine green, one 10 ml vial of sterile Water for injection, and one SPY Elite sterile drape. The second component to the system is the SPY Elite Device which contains a near-infrared light source that illuminates the fluorescent agent within the tissues, an HD video camera captures the intensity of fluorescent marker in real-time, and software that allows the user to capture relative and absolute perfusion values within the surgical field.
16062041|NCT02440295|Drug|Indocyaine Green|Indocyaine Green (ICG) is a non-nephrotoxic fluorescent imaging agent with a half-life of 2.5-3 minutes that is administered intravenously.
16062042|NCT02440256|Other|Expanded HIV care in Opioid Substitution Treatment|The EHOST intervention entails in-person presentations and consultation sessions with individual OST sites that will: (i) provide rationale for the study (ii) outline action items of the intervention; and (iii) describe guidelines around HIV testing and care. The EHOST intervention will be delivered at three distinct times: (i) at point of OST entry; (ii) following 7 days non-adherence; and (iii) at bi-annual intervals. The interventions are comprised of HIV test offers for individuals of unknown HIV status; offers of HIV-related care, including cluster of differentiation 4 (CD4), plasma viral load (pVL) and resistance tests, along with HAART initiation for those known to be HIV-positive, not on HAART; and regular monitoring for those known to be HIV positive, on HAART.
16062043|NCT02440243|Drug|Purethal|prerseasonal course of SCIT - three years
16062044|NCT02440243|Drug|Purethal -placebo|preseasonal course of SCIT - three years
16062045|NCT02440230|Drug|OFS + Anastrozole|"Ovarian function suppression can be achieved by choice of goserelin at a dose of 3.6 mg administered by means of subcutaneous injection every 28 days,bilateral oophorectomy,or bilateral ovarian irradiation.
~Patients will take anastrozole 1mg qd."
16062046|NCT02440230|Drug|OFS + Exemestane|Patients will take exemestane 25mg qd. Ovarian function suppression can be achieved by choice of goserelin at a dose of 3.6 mg administered by means of subcutaneous injection every 28 days,bilateral oophorectomy,or bilateral ovarian irradiation.
16062047|NCT02440204|Procedure|Intubation|After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be injected according to their group and intubation will be performed 90 seconds after.
16062048|NCT02440204|Drug|Remifentanil|After setting the end-tidal sevoflurane concentration in a predetermined concentration, remifentanil will be administered according to their group in 1 minute to prevent remifentanil induced rigidity or complications.
16062049|NCT02440204|Drug|Sevoflurane|The end-tidal sevoflurane concentration will be set as predetermined, which starts from 2.5 vol% and adjusted by the up-and-down study model which have been described by Dixon JW et al.
16062050|NCT02440191|Radiation|3DCRT|conventional radiotherapy
16062051|NCT02440178|Drug|Micafungin|
16062052|NCT02440165|Behavioral|Nursing nutrition intervention|"The early nursing nutrition intervention will include malnutrition screening (during outpatient clinic visit) with the MUST. If patients are ´at risk for malnutrition´ or ´malnourished´, a standardized nutrition care plan will be discussed with the patient by the nurse. This nutrition care plan will include:
~Information and advice;
~Examples of energy and protein rich meals;
~patients will be asked to register their nutritional intake for two days at home;
~after a week, the nurse will call the patients to answer questions and to give advice.
~This nutrition care plan will be tailored to the individual patient requirements.
~Furthermore, if patients are 'malnourished', a visit to the dietician is always suggested, because this is usual care."
16062053|NCT02440152|Device|Suzhou Sceneray® DBS System|We plan to use the SceneRay 1242 (SceneRay, SuZhou, China) electrode with a diameter of 1.27 mm and 4 contacts. The SceneRay 1242 electrode combined with the SceneRay 1181 implantable pulse generator has the advantage of adaptive coverage area for the Ventral Capsule/Ventral Striatum, enabling simultaneous implantation in the nucleus accumbens (NAc; 2 ventral contacts) and the anterior limb of the internal capsule (ALIC; 2 dorsal contacts) with independently programmed parameters such as frequency, amplitude, and voltage; and remote and wireless programing, which allows for convenient and prompt adjustments in emergency situations. The contact length is 3.0 mm and the spacings between the ventral and dorsal contacts are 2 mm, 4 mm, and 4 mm, respectively, spanning a total length of 22.5 mm (3 + 2 + 3 + 4 + 3 + 4 + 3 mm, with 0.5 mm projecting from the electrode tip).
16062054|NCT02440139|Device|ClearRead CT Insight|During the second reading session (concurrent read), the radiologist will be presented with a standard appearing CT with CADe marks placed and the vessel suppressed same slice with the vessel suppressed view as the intervention. The second image, vessel suppressed, will be grayed out until the radiologist move the mouse to the second panel. The radiologist will mark locations. These may or may not correspond to the locations of the CAD markers. As before, the radiologist will assign a level of suspicious to each mark and indicate the need, if any, of an additional diagnostic action (CT Follow-up, Contrast CT, PET-CT, or Biopsy).
16062055|NCT02440113|Device|Nellix|Nellix Implantation
16062056|NCT02440100|Drug|PF-06648671|experimental Pfizer compound which will be dosed as oral suspension, once a day for 14 days
16062057|NCT02440100|Drug|Midazolam|commercial available oral solution of 2 mg midazolam as CYP3A probe substrate for drug interaction evaluation. Midazolam will be given as single dose with and without co-administration of PF-06648671
16062058|NCT02440100|Drug|Placebo|Matching placebo which will be given as oral suspension, once a day for 14 days
16062059|NCT02440087|Dietary Supplement|Refill Bypass|Dietary supplement
16062060|NCT02440074|Other|Autologous bone marrow mesenchymal stem cells|Bone marrow collection from patient, mesenchymal cells isolation and expansion under Good Manufacturing Practice (GMP) conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by intradiscal injection.
16062061|NCT02440061|Drug|Synthetic human AG|Synthetic human AG (0.28 μg/kg) bolus over 1 minute followed by 2 μg/kg/hr continuous infusion for 4.5 hours.
16062062|NCT02440061|Drug|Arginine|Arginine hydrochloride (5 g) intravenously over 45 seconds.
16062063|NCT02440061|Drug|0.9% saline solution|A continuous infusion of 0.9% saline solution (control) for 4.5 hours.
16062162|NCT02439281|Drug|Clonidine|Only the Ropivacaine /clonidine group will receive clonidine (2mcg/kg) injected with ropivacaine.
16062064|NCT02440048|Device|Bond Apatite synthetic bone substitute|Synthetic bone grafts had been successful for ridge preservation. Calcium sulfate is the oldest material, being in use in dentistry for more than 30 years ago, and in orthopedics for more than 100 years ago. Calcium sulfate is completely absorbed and constitutes a matrix on wich bone is able to grow (osteoconductive). It does not induce inflammation and does not alter calcium levels in the blood flow.Previous studies has shown that calcium sulfate is completely replaced by bone. On the other hand, fast absorption of calcium sulfates can alter the dimensional stability of the graft. Adding Hydroxy Apatite may improve stability during bone remodeling.
16062065|NCT02440048|Device|BioOss bovine bone substitute|To assess efficiency of ridge preservation (in vertical and horizontal dimensions) after tooth extraction using Calcium Sulfate with HA (®Bond-apatite) compared to the use of bovine bone substitute (BioOss®) and to extraction only as negative control.
16062066|NCT02440035|Biological|Ad35.RSV.FA2|Participants will receive Intramuscular injection of Ad35.RSV.FA2 (1x10^11) virus particles on Day 1 and 85 in Group 1. Intramuscular injection of Ad35.RSV.FA2 (1x10^11) virus particles on Day 1 and 169 in Group 2. Intramuscular injection of Ad35.RSV.FA2 (1x10^11) virus particles on Day 1 in Group 3.
16062067|NCT02440035|Biological|Ad26.RSV.FA2|Participants will receive Intramuscular injection of Ad26.RSV.FA2 (5x10^10 virus particles [vp]) on Day 169 in Group 1. Intramuscular injection of Ad26.RSV.FA2 (5x10^10) virus particles on Day 169 in Group 3. Intramuscular injection of Ad26.RSV.FA2 (5x10^10) virus particles on Day 169 in Group 4.
16062068|NCT02440035|Drug|Placebo|Participants will receive intramuscular injection of placebo (sterile formulation buffer) on Day 85 in Group 2. One intramuscular injections of placebo on Day 85 in Group 3. Two intramuscular injections of placebo on Day 1, and Day 85 in Group 4.
16062069|NCT02440022|Combination Product|Lutonix DCB|
16062070|NCT02440022|Device|Standard Balloon Angioplasty Catheter|
16062071|NCT02440022|Procedure|Percutaneous Transluminal Angiography|"Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored."
16062072|NCT02440009|Drug|Itraconazole|Oral itraconazole 200 mg BD for 6 months
16062073|NCT02440009|Drug|Glucocorticoids|Oral prednisolone 0.5 mg/kg/day for 4 weeks; 0.25 mg/kg/day for 4 weeks; 0.125 mg/kg/day for 4 weeks. Then taper by 5 mg every 4 weeks and discontinue by the end of 4 months.
16062074|NCT02439996|Drug|IVIG (1g/kg,once)|"Group C patients received IVIG 1g/kg per day once. The IVIG was started on the fifth to tenth day of illness. In combination with IVIG, the patients were administered aspirin at a dose of 30 mg/kg per day; this dose was reduced to 3-5 mg/kg per day after the fever disappeared for 3 days and the CRP value was ≤8mg/L. Patients who were admitted before the fourth day of illness were treated only with aspirin. Each immunoglobulin was administered at a dose of 1 g/kg for 10h.
~Patients who did not respond to initial IVIG therapy were given a second dose of IVIG 24-36 hours after the initial dose at 2g/kg. Patients who did not respond to second dose IVIG were given methylprednisolone 10mg/kg for 3 days or infliximab 5mg/kg once."
16062075|NCT02439996|Drug|IVIG (1g/kg,twice)|"Group B patients received IVIG 1g/kg for 2 days continuously. The IVIG was started on the fifth to tenth day of illness. In combination with IVIG, the patients were administered aspirin at a dose of 30 mg/kg per day; this dose was reduced to 3-5 mg/kg per day after the fever disappeared for 3 days and the CRP value was ≤8mg/L. Patients who were admitted before the fourth day of illness were treated only with aspirin. Each immunoglobulin was administered at a dose of 1 g/kg for 10h.
~Patients who did not respond to initial IVIG therapy were given a second dose of IVIG 24-36 hours after the initial dose at 2g/kg. Patients who did not respond to second dose IVIG were given methylprednisolone 10mg/kg for 3 days or infliximab 5mg/kg once."
16062076|NCT02439996|Drug|IVIG (2g/kg.once)|"Group A patients received IVIG 2g/kg per day once. The IVIG was started on the fifth to tenth day of illness. In combination with IVIG, the patients were administered aspirin at a dose of 30 mg/kg per day; this dose was reduced to 3-5 mg/kg per day after the fever disappeared for 3 days and the CRP value was ≤8mg/L. Patients who were admitted before the fourth day of illness were treated only with aspirin. Each immunoglobulin was administered at a dose of 1 g/kg for 10h.
~Patients who did not respond to initial IVIG therapy were given a second dose of IVIG 24-36 hours after the initial dose at 2g/kg. Patients who did not respond to second dose IVIG were given methylprednisolone 10mg/kg for 3 days or infliximab 5mg/kg once."
16062077|NCT02439983|Dietary Supplement|Proprietary Nutritional Supplement|2 capsules taken by mouth with morning and evening meals.
16062078|NCT02439983|Dietary Supplement|Placebo|2 capsules taken by mouth with morning and evening meals.
16062079|NCT02439970|Drug|Brincidofovir|
16062080|NCT02439970|Drug|Valganciclovir|
16062081|NCT02439957|Drug|Brincidofovir|
16062082|NCT02439957|Drug|Valganciclovir|
16062083|NCT02439944|Drug|Nicotine patch|
16062084|NCT02439944|Drug|Nicotine mouthspray|
16062085|NCT02439931|Behavioral|Remote psychosocial intervention|
16062086|NCT02439905|Drug|Dexmedetomidine|In dexmedetomidine group, dexmedetomidine infusion starts at the time after induction of general anesthesia and before one lung ventilation. The infusion has continued until end of the operation.
16062087|NCT02439905|Drug|Placebo control|In normal saline group, normal saline infusion starts at the time after induction of general anesthesia and before one lung ventilation. The infusion has continued until end of the operation.
16062088|NCT02439892|Behavioral|Exercise and nutrition during radiotherapy|The intervention consists of physical exercise, nutritional counselling and supplements. The exercise sessions will be conducted twice a week for 30 minutes each time during the RT treatment period, and include a main part of progressive resistance training (PRT). The PRT will be conducted by conventional upper and lower body exercises at a load of 60 - 80 % of 1 repetition maximum (RM) in 3-4 sets of 6-12 repetitions. The patients will receive nutritional information and dietary advice, and up to 2 energy dense oral nutritional supplements (ONS) daily. A nutrition interview will be conducted at study baseline and individual goals and targets will be set during the first counselling and monitored during the intervention period.
16062120|NCT02439619|Other|TechCare|The TechCare software is being developed specifically for use on a touch screen mobile phone. The mobile application will alert participants through notifications and ask a number of questions. Based on participant responses the app will provide a CBT based response to individuals or the service users preferred multimedia such as music, images and videos.
16062089|NCT02439892|Behavioral|Multidimensional rehabilitation after radiotherapy|The intervention consists of physical exercise, nutritional counselling and supplements and patient education. The exercise sessions will be conducted 3 times a week for 45 minutes each time during the 3 week rehabilitation programme, and include a main part of progressive resistance training (PRT). PRT will be conducted as described in the intervention during treatment. The nutritional intervention will be carried out as described in the intervention during treatment. Patient education will be run as 45-60 minutes lecture/group discussion on relevant topics, lead by health professionals.
16062090|NCT02439879|Drug|Alpha lipoic acid|Alpha lipoic acid 1800 mg PO divided in 3 doses for 4 weeks . If total symptoms score decreased >3 points patients received alpha lipoic acid 600 mg PO each day or no treatment for 16 weeks.
16062091|NCT02439866|Drug|placebo|gelatinous capsules filled with sugar as placebo
16062092|NCT02439866|Drug|Intravenous methylprednisolone|Intravenous methylprednisolone (Solu-Medrol, Pharmacia Pharmaceutical Company, Belgium) 500 mg twice a day for 3 days followed by 2 weeks of oral prednisolone 1mg/kg/day (Prednisolone Fort; Sina Daroo, Iran
16062093|NCT02439866|Drug|normobaric oxygen with face mask|normobaric oxygen100% with face mask in sitting position, at a flow rate of 5 liters per minute for 1 hour twice a day for two weeks
16062094|NCT02439853|Behavioral|Monthly Check-in Session|Subjects in the Check-In group will have an online session with a speech-language pathologist 3-, 4-, and 5-months from the subject's enrollment date.
16062095|NCT02439827|Behavioral|"Fortaleça sua Saúde program"|The program duration was of one academic semester (approximately four months) in 2014. The intervention strategies focus on teachers' training and activities on health in curriculum (including a specific training to Physical Education teachers), active opportunities in the school environment (availability of spaces and materials for PA) and health education (production and exhibition of health material at school, and distributing pamphlets to students and parents).
16062096|NCT02439814|Drug|Pregnenolone|Pregnenolone is a steroid that occurs naturally in the body, and early studies have shown that pregnenolone may block the effects of marijuana intoxication
16062097|NCT02439814|Other|Placebo|Inactive comparator
16062098|NCT02439801|Procedure|PEEP 0|0 cmH2O positive end expiratory pressure
16062099|NCT02439801|Procedure|PEEP 5|5 cmH2O positive end expiratory pressure
16062100|NCT02439801|Procedure|PEEP 8|8 cmH2O positive end expiratory pressure
16062101|NCT02439788|Drug|cyclophosphamide|500 mg/m2/day x 2 days; for patients <12 kg the dose is 16.7 mg/kg/day x 2 days; Cyclophospamide will be given daily starting Day -4 prior to administration of GINAKIT cells.
16062102|NCT02439788|Drug|Fludarabine|30 mg/m2/day x 3 days; for patients <12 kg the dose is 1 mg/kg/day x 3 days; Fludarabine will be given daily starting Day -4 prior to administration of GINAKIT cells
16062103|NCT02439788|Genetic|GINAKIT Cells|"Dose Level 1 = 3 x 10^6
~Dose Level 2 = 1 x 10^7
~Dose Level 3 = 3 x 10^7
~Dose Level 4 = 1 x 10^8
~After the end of the 4 week evaluation period, if subjects have not had a severe side effects and if disease has not gotten worse, the subjects may be offered additional doses of the same cell dose in the future."
16062104|NCT02439775|Device|Symplicity Spyral™ multi-electrode renal denervation system|After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
16062105|NCT02439775|Procedure|Sham Procedure|After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
16062106|NCT02439762|Behavioral|Cognitive Behavioral Therapy (CBT)|The therapeutic intervention group consists of 8, one-hour individual therapy sessions delivered over the course of 3-4 weeks with a trained CBT therapist. These sessions are designed to provide beneficial coping strategies that are helpful in dealing with both substance use and suicidal thoughts.
16062107|NCT02439762|Behavioral|Supportive Psycho-education (SPC)|This active control condition consists of 8, one-hour individual therapy sessions delivered over the course of 3-4 weeks with a trained therapist. The sessions will provide detailed information about substance use, suicide risk, and depression to those enrolled.
16062108|NCT02439749|Device|Symplicity Spyral™ multi-electrode renal denervation system|After a renal angiography according to standard procedures, subjects remain blinded and are immediately treated with the renal denervation procedure after randomization.
16062109|NCT02439749|Procedure|Sham Procedure|After a renal angiography according to standard procedures, subjects remain blinded and remain on the catheterization lab table for at least 20 minutes prior to introducer sheath removal.
16062110|NCT02439736|Other|Blood draw within 12 hours of head injury|
16062111|NCT02439723|Drug|Regorafenib|
16062112|NCT02439710|Other|Quality of life measure (survey)|The QoL tool is a questionnaire
16062113|NCT02439697|Other|Darbepoetin alfa|Conversion from Aranesp® to NESP®
16062114|NCT02439671|Behavioral|McGill Transition Support Program|"The McGill Transition Support Program is manual-based, including 15 modules of curriculum, five in each of the following domains of skills:
~Social communication (e.g. listening, perspective taking)
~Self-determination (e.g. problem-solving, self-advocacy)
~Working with others (e.g. knowing your context, teamwork)
~Nine out of the 15 modules are selected for each group according to the common needs endorsed by participants on a needs assessment questionnaire. Each group consists of 4 adults and two facilitators who were graduate students in Speech Language Pathology or Educational Psychology.
~The intervention follows a Self-Determination Learning Model of Instruction (SDLMI) that considers the individual's strengths and needs in the development of personal goals and plans for one's future. A workbook is used to accompany each module with the aim of having the participants practice and generalize the main content messages."
16062115|NCT02439658|Drug|Dofetilide and/or sotalol|This is an observational study of patients receiving Dofetilide and/or sotalol as part of their routine clinical care. Patients receiving either of these medications will be compared with population controls for genetic analysis.
16062116|NCT02439632|Drug|prulifloxacin|
16062117|NCT02439632|Drug|Levofloxacin|Levofloxacin hydrochloride tablet 250 mg/tablet, oral administration of a tablet daily for a total of 3 days.
16062118|NCT02439632|Drug|Prulifloxacin Placebo|Placebo of prulifloxacin film-coated tablet without active components.
16062119|NCT02439632|Drug|Levofloxacin Placebo|Placebo of levofloxacin hydrochloride tablet without active components.
16062430|NCT02437253|Other|Placebo|Saline placebo
16062121|NCT02439606|Device|Glide Rite Rigid Stylet group|Intubation with the GlideScope® video-laryngoscope and styletted the tracheal tube using manufacturer's GlideRite Rigid Stylet (GRS) (GVL - ST1; Verathon Medical Inc., Bothell, WA, USA). Time till successful intubation of the patient is calculated.
16062122|NCT02439606|Device|Parker Flex-It directional stylet group|Intubated with the GlideScope® video-laryngoscope and styletted the tracheal tube using Parker-Flex-It directional Stylet (Parker Medical, Colorado, USA) (Flexi-Stylet). Time till successful intubation of the patient is calculated.
16062123|NCT02439593|Other|Chemoradiotherapy (CTRT)|CTRT arm: Locoregional radiotherapy along with concurrent weekly gemcitabine
16062124|NCT02439593|Other|Thermochemoradiotherapy (CTRTHT)|Locoregional hyperthermia with concurrent chemoradiotherapy with weekly gemcitabine
16062125|NCT02439580|Dietary Supplement|Annona muricata extract|ethanol-soluble fraction of water extract
16062126|NCT02439580|Dietary Supplement|Placebo|maltose
16062127|NCT02439567|Device|Fibroscan: Liver and Spleen elastography|In cirrhotic patients treated with antivirals for HCV infection, repeated liver and spleen stiffness measures with Fibroscan will be performed to predict the presence of clinically significant and severe portal hypertension.
16062128|NCT02439541|Biological|UCMSC group|Human umbilical cord MSCs are transplanted by intracoronary infusion(1×10^7)
16062129|NCT02439528|Genetic|Genetic analysis|"One part of these patients is already included in a cohort: for them the blood sample will be centralized and then analyzed.
~The other part of these patients will be recruited during the study: for them intervention will be blood samples for further genetic analysis."
16062130|NCT02439515|Device|Cycling|Voluntary cycling augmented by electrical stimulation and biofeedback
16062131|NCT02439515|Device|Balance|Balance control exercises with visual biofeedback
16062132|NCT02439515|Other|Standard physical therapy|It consists of stretching, muscular conditioning, exercises for trunk control, standing, and walking training, and upper limb rehabilitation.
16062133|NCT02439502|Device|Fuse® system|Fuse® system will be used to perform gastro and endoscopic diagnostic procedures for upper and lower GI tract.
16062134|NCT02439489|Drug|BKM120-CIS|"BKM120 will be delivered orally once daily on continuous at the dose of 60 mg (dose level 1), 80 mg (dose level 2) and 100 (dose level 3). Cisplatin will be delivered intravenously at the dose of 75 mg/m2 on day 1 every 3 weeks at each dose level of BKM120.
~In the absence of BKM120 DLT, each level will be administered to 3 patients A minimum of 2 cycles per each dose level will be administered in the absence of disease progression or toxicity"
16062135|NCT02439489|Drug|BKM120-CARBO|"BKM120 will be delivered orally once daily on continuous at the dose of 60 mg (dose level 1), 80 mg (dose level 2) and 100 (dose level 3). Carboplatin will be delivered intravenously at AUC 5 on day 1 every 3 weeks at each dose level of BKM120. Should dose level 3 be completed, carboplatin will be given at AUC 6 and BKM120 at 100 mg.
~In the absence of BKM120 DLT, each level will be administered to 3 patients A minimum of 2 cycles per each dose level will be administered in the absence of disease progression or toxicity"
16062136|NCT02439463|Procedure|Below-knee amputation|Patients with traumatic below-knee amputation.
16062137|NCT02439450|Biological|Viagenpumatucel-L|Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
16062138|NCT02439450|Drug|Nivolumab|Nivolumab 240mg IV q2weeks for 18 weeks or until disease progression or unacceptable toxicity. After the completion of 18 weeks of combination therapy, patients may receive either nivolumab dosing schedule listed in the current approved package insert (every 2 weeks or every 4 weeks) per Investigator discretion.
16062139|NCT02439450|Drug|Pembrolizumab|The recommended dose of KEYTRUDA (pembrolizumab) is 200 mg administered as an intravenous infusion over 30 minutes every 3 weeks until disease progression, unacceptable toxicity, or up to 24 months in patients without disease progression.
16062140|NCT02439450|Drug|Pemetrexed|The recommended dose of ALIMTA (pemetrexed) when administered with carboplatin and pembrolizumab for the initial treatment of NSCLC in patients with a creatinine clearance (calculated by Cockcroft-Gault equation) of 45 mL/min or greater is 500 mg/m2 administered as an intravenous infusion over 10 minutes prior to carboplatin on Day 1 of each 21-day cycle for 4 cycles. Pembrolizumab should be administered prior to ALIMTA when given on the same day.
16062141|NCT02439437|Behavioral|Psychosocial Intervention|Telephone-based psychosocial intervention involving Eight telephone encounters. Each encounter will focus on strategies for dealing with pain and stress, and how to apply these strategies to patients own experiences.
16062142|NCT02439424|Device|Reactive ATP|"Reactive ATP turned to on"
16062143|NCT02439411|Drug|Trametinib|
16062144|NCT02439398|Biological|Allogeneic human cardiac stem cells (CSCs)|Allogeneic human CSCs is a new cell medicine based on cells isolated from human heart biological samples (right atrium appendage of donors) and expanded in vitro.
16062145|NCT02439398|Other|Human Serum Albumin-HSA 5%|Human Serum Albumin (HSA) is a well-known physiologic protein widely used in clinical practice and without known toxicity after parenteral administration.
16062146|NCT02439385|Drug|Avastin/FOLFIRI|Avastin: 5mg/kg iv on day1, every 14 days. Irinotecan: 180 mg /m2 iv on day1, every 14 days. Leucovorin: 200 mg/m2 iv on day1,2 every 14 days. 5-fluorouracil bolus: 400 mg/m2 iv on day1,2 every 14 days. 5-fluorouracil infusion: 1200 mg/m2 iv on day1,2 every 14 days.
16062147|NCT02439385|Dietary Supplement|Curcumin|Dietary supplement of nanostructured lipid curcumin particle 100mg po bid daily
16062148|NCT02439359|Drug|CF-301|Dose escalation
16062149|NCT02439359|Drug|Placebo|
16062150|NCT02439346|Drug|BAY1143269 tablet|BAY 1143269 5 mg or 25 mg tablet. Each treatment cycle will last 21 days.
16062151|NCT02439333|Device|Nasal high flow cannula (Fisher & Paykel Healthcare, Auckland, New Zealand)|Nasal high flow therapy
16062152|NCT02439333|Device|nasal catheter or Venturi mask|Conventional oxygen therapy
16062153|NCT02439320|Drug|Lasmiditan 100 mg|
16062154|NCT02439320|Drug|Lasmiditan 200 mg|
16062155|NCT02439320|Drug|Placebo (matches lasmiditan doses)|
16062156|NCT02439307|Drug|Rifaximin|1200 mg of rifaximin for 2 weeks.
16062157|NCT02439307|Drug|Placebo|Placebo for 2 weeks
16062158|NCT02439294|Other|Without Obstructive Sleep Apnea (syndrome)|
16062159|NCT02439294|Other|Mild or moderate Obstructive Sleep Apnea (syndrome)|
16062160|NCT02439294|Other|Severe Obstructive Sleep Apnea (syndrome)|
16062161|NCT02439294|Device|CPAP|
16062163|NCT02439281|Drug|Ropivacaine|One hundred pediatric patients (10-17 years old) scheduled for laparoscopic appendectomy will be randomized to the two treatment groups: the Ropivacaine Group will receive ropivacaine 0.5% (10 ml) injected bilateral in Both groups will receive ropivacaine 0.5% (10 ml) injected bilaterally for the rectus sheath block
16062164|NCT02439255|Other|Laboratory Biomarker Analysis|Correlative studies
16062165|NCT02439255|Dietary Supplement|Phytochemical|Given BRB nectar PO
16062166|NCT02439255|Other|Placebo|Given PO
16062167|NCT02439255|Other|Screening Questionnaire Administration|Ancillary studies
16062168|NCT02439242|Drug|fluid challenge of saline|250 ml of saline
16062169|NCT02439216|Drug|Edasalonexent|
16062170|NCT02439216|Drug|Placebo|
16062171|NCT02439203|Drug|JM-010|
16062172|NCT02439203|Drug|Placebo|
16062173|NCT02439190|Drug|BMS-986120|
16062174|NCT02439190|Drug|Aspirin|
16062175|NCT02439190|Drug|Clopidogrel|
16062176|NCT02439177|Device|Blood glucose monitoring system (Omnitest 3)|
16062177|NCT02439177|Device|Blood glucose monitoring system (Omnitest 5)|
16062178|NCT02439164|Drug|Midazolam|specific benzodiazepine agonist midazolam will be used titrate to desired sedation level, its specific antagonist flumazenil will also be used
16062179|NCT02439151|Device|New lung ventilation strategy|New ventilation strateg: pressure assist control mode; inspiratory pressure was lowered to keep Ppeak less than 25cmH2O; set the PEEP at such a level that expiratory transpulmonary pressure stays between 0 and 5 cmH2O; respiratory rate of 10 breaths per minute; FiO2 less than 0.5.
16062180|NCT02439151|Device|Conventional ventilation strategy|Conventional ventilation strategy: pressure assist control mode; keep the Ppeak between 20 and 25 cmH2O; set PEEP between 10 and 15 cmH2O; respiratory rate of 10 breaths per minute; FiO2 less than 0.5.
16062181|NCT02439138|Drug|GS-1101|Oral twice daily for 6 months followed by once daily until disease progression or unacceptable toxicity.
16062182|NCT02439125|Drug|Eltoprazine HCl|2.5 mg b.i.d. orally for 3 weeks
16062183|NCT02439125|Drug|Eltoprazine HCl|5.0 mg b.i.d. orally for 3 weeks
16062184|NCT02439125|Drug|Eltoprazine HCl|7.5 mg b.i.d. orally for 3 weeks
16062185|NCT02439125|Drug|Placebo|b.i.d. orally for 3 weeks
16062186|NCT02439112|Other|Exercise|"8 supervised in-hospital training sessions in a period of 10 weeks. On a general level, the intervention will follow the Danish physical activity guidelines for elderly >65 years (Sundhedsstyrelsen 2011, see link) and consist of strength exercise, aerobic exercise and physical activity.
~Bone involvement will taken into consideration in all parts of the exercise program by excluding and including specific exercises and mode of exercise according to location and extent of bone involvement (Galvão 2011; Cormie 2013)"
16062187|NCT02439086|Device|PET-CT Scan|patients will have 2 PET CT scans: one before radiotherapy, and one 9 weeks after.
16062188|NCT02439073|Behavioral|Rehabilitation|The postoperative intervention are the same in both intervention groups and consists of a supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions, and three group-based lessons in health-promoting behavior. If the participants have special needs in terms of smoking cessation, nutritional counseling or patient education, this is offered too.The postoperative physical exercise consists of an individually prepared supervised strength exercise - and a group-based cardiovascular exercise twice a week (60 minutes/session) on non-consecutive days for 12 weeks, a total of 24 sessions.
16062189|NCT02439060|Other|Acellular Cadaveric Dermal Matrix|Undergo intraperitoneal prophylactic mesh placement
16062190|NCT02439047|Procedure|Biological samples collection|"-Peritoneal samples : will be collected during abdominal surgery
~A biopsy from 1 to 2 cm2 will be performed in healthy peritoneum
~- Adipose tissue samples : will be collected during surgery for breast reconstruction"
16062191|NCT02439034|Drug|Paracetamol|Paracetamol 1 g IV then 1 g 3 times a day IV or oral (PO)
16062192|NCT02439034|Drug|Ketoprofen|Ketoprofen* 100 mg (IV then PO) : Ketoprofen 100 mg IV 2 times a day or Ketoprofen LP 100 mg PO 2 times a day.
16062193|NCT02439021|Device|COBRA|
16062194|NCT02439021|Device|LMA|
16062195|NCT02439008|Procedure|Blood samples collection before radiotherapy|"Nine blood samples (35 mL each) will be collected in each patient before, during and after radiotherapy treatment.
~Before radiotherapy:
~Sample T0: after registration, in the days running up to the administration of the first fraction of radiotherapy"
16062196|NCT02439008|Procedure|Blood samples collection during radiotherapy|"Sample T1: within 15 minutes after the administration of the first fraction,
~Sample T2: within 15 minutes after the administration of the second fraction,
~Sample T3: within 15 minutes after the administration of the third fraction"
16062197|NCT02439008|Procedure|Blood samples collection after radiotherapy|"Sample T4: one week after the end of the radiotherapy,
~Samples T5 to T8: respectively 3 months, six months, 9 months and 12 months after the end of the radiotherapy."
16062198|NCT02439008|Radiation|Radiotherapy|
16062199|NCT02438995|Drug|Intraarterial Cetxuimab (Erbitux)|Super-Selective Intraarterial Infusion of Cetuximab (Erbitux)
16062200|NCT02438982|Drug|Tacrolimus|Oral Tacrolimus (Tablet form) 0.2mg/kg/day starting dose. Targeting trough level of Tacrolimus (T0) 5-7 ng/ml.
16062201|NCT02438982|Drug|Rituximab|Two rituximab infusions will be administered once every week at standard dose (Intravenous infusion of rituximab 375mg/mt2). Circulating B cells will be measured 24 hours after rituximab administration. If >5 B cells per mm3, it will be measured again after 1 week. If count is still >5 B cells per mm3, third & fourth doses of rituximab will be given.
16062202|NCT02438956|Dietary Supplement|Setria glutathione supplement|500 mg/day capsule taken in the morning for 120 days.
16062203|NCT02438956|Dietary Supplement|Crystalline Cellulose|500 mg/day capsule taken in the morning for 120 days.
16062204|NCT02438943|Other|Audit|An assessment of medical records using a pre-specified audit instrument to assess the level of care given for clinic attendees with cardiovascular disease including dyslipidemia
16062205|NCT02438943|Other|Physician Intervention|Feedback Training sessions for physicians inclusive Motivational Interviewing training and the use of physician reminders on medical records before each clinic session
16062206|NCT02438930|Behavioral|Motivational interviewing intervention during HIV testing|
16062207|NCT02438930|Behavioral|Standard-of-care counseling during HIV testing|
16063568|NCT02428712|Drug|PLX8394|(Formulation 1 or Formulation 2)
16062208|NCT02438904|Biological|CD34 Positive Stem Cell Infusion|Participants infused by vein with around 1 - 4 million/kg CD34+ selected cells.
16062209|NCT02438891|Behavioral|Cognitive behavioral therapy|Cognitive behavioral therapy is a form of tinnitus psychotherapy which aims to help patients control negative thoughts or emotions associated with tinnitus.
16062210|NCT02438878|Behavioral|Baby Behavior|
16062211|NCT02438865|Drug|Immediate instillation of intravesical chemotherapy-Epirubicin-|
16062212|NCT02438865|Drug|Maintainance therapy of intravesical chemotherapy-Epirubicin-|
16062213|NCT02438852|Other|Placebo|Given IV
16062214|NCT02438852|Other|Questionnaire Administration|Ancillary studies
16062215|NCT02438852|Drug|Ropivacaine Hydrochloride|Given IV
16062216|NCT02438826|Drug|Galcanezumab 300 mg|Administered SC
16062217|NCT02438826|Drug|Placebo|Administered SC
16062218|NCT02438813|Drug|Deoxycholic acid|Deoxycholic acid (ATX-101) injection as the treatment of SMF as per standard of care in clinical practice.
16062219|NCT02438813|Procedure|Surgical Procedures|Surgical procedures for treatment of SMF as per standard of care in clinical practice.
16062220|NCT02438813|Procedure|Laser Liposuction|Laser Liposuction for the treatment of SMF as per standard of care in clinical practice..
16062221|NCT02438813|Device|Energy Devices|Energy Devices for the treatment of SMF as per standard of care in clinical practice.
16062222|NCT02438813|Other|Other Treatments|Other treatments for SMF as per standard of care in clinical practice.
16062223|NCT02438800|Behavioral|LARC First Video|LARC First is an evidence-based, 12-minute video developed by the CHOICE project that features women of all racial and ethnic backgrounds describing LARC methods of contraception in simple, understandable language with summary text when appropriate.
16062224|NCT02438787|Drug|Placebo|Placebo subcutaneous (SC) injection at Weeks 0, 4, and 16 in Group 1.
16062225|NCT02438787|Drug|Ustekinumab 45 mg|Ustekinumab 45 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 52 in Group 1. Participants will start with ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52 in Group 2.
16062226|NCT02438787|Drug|Ustekinumab 90 mg|Ustekinumab 90 mg SC injection at Weeks 24 and 28 followed by q12w dosing, with the last administration of study agent at Week 52 in Group 1. Participants will start with ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 52 in Group 3.
16062227|NCT02438787|Drug|Golimumab 50 mg|Participants who meet EE criteria (less than [<] 10 percent [%] improvement from baseline in both total back pain and morning stiffness measures at both Week 12 and Week 16) will be administered open-label golimumab 50 mg SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52 in Group 1, 2 and 3.
16062228|NCT02438774|Behavioral|post-harvest intervention package|The intervention group received post-harvest intervention package. The package is composed of 5 components, namely 1) hand sorting, 2) drying surface, 3) proper drying, 4) application of insecticide, 5) dehulling . The intervention will last for 7 months.
16062229|NCT02438774|Behavioral|Routine agriculture extension services|This group continued to receive routine agriculture education on good practices for handling crops; an agricultural extension service offered to farmers regularly by village agriculture extension officer at village level. The extension services provided includes the provision of farmers with knowledge, information, experiences and technologies needed to increase and sustain productivity and avoiding crop spoilage during storage for improved wellbeing and livelihoods
16062230|NCT02438761|Drug|PF-05212384|"PF-05212384 will be delivered by intra-venous route at a fixed dose of 150 mg per week. Each treatment cycle includes four weekly injections
~The treatment is administered in cycles of 28 days for a period of 4 cycles. Patients will be treated on a weekly basis continuously during 112 days or until progression."
16062231|NCT02438748|Device|Repetitive Transcranial Magnetic Stimulation|A non-invasive method of brain stimulation.
16062232|NCT02438735|Procedure|laparoscopic endometrioma excision|
16062233|NCT02438735|Other|Conservative follow up|
16062234|NCT02438722|Drug|Afatinib Dimaleate|Given PO
16062235|NCT02438722|Biological|Cetuximab|Given IV
16062236|NCT02438722|Other|Laboratory Biomarker Analysis|Correlative studies
16062237|NCT02438709|Drug|COX-2 inhibitor|oral COX-2 inhibitor intake 60mg qd
16062238|NCT02438696|Drug|BI 1060469, iFF, Test|
16062239|NCT02438696|Drug|BI 1060469, iFF, Test|
16062240|NCT02438696|Drug|BI 1060469, TF1, Reference|
16062241|NCT02438696|Drug|BI 1060469, TF2, Test|
16062242|NCT02438696|Drug|BI 1060469, TF2, Test|
16062243|NCT02438696|Drug|BI 1060469, iFF, Test|
16062244|NCT02438696|Drug|BI 1060469, TF1, Reference|
16062245|NCT02438696|Drug|BI 1060469, iFF, Test|
16062246|NCT02438696|Drug|BI 1060469, iFF, Test|
16062247|NCT02438696|Drug|BI 1060469, TF1, Reference|
16062248|NCT02438696|Drug|BI 1060469, TF2, Test|
16062249|NCT02438696|Drug|BI 1060469, TF1, Reference|
16062250|NCT02438696|Drug|BI 1060469, TF1, Reference|
16062251|NCT02438696|Drug|BI 1060469, TF2, Test|
16062252|NCT02438696|Drug|BI 1060469, TF2, Test|
16062253|NCT02438696|Drug|BI 1060469, iFF, Test|
16062254|NCT02438696|Drug|BI 1060469, TF2, Test|
16062255|NCT02438696|Drug|BI 1060469, TF1, Reference|
16062256|NCT02438683|Drug|BI 409306|medium dose, single dose, oral administration
16062257|NCT02438683|Drug|BI 409306|low dose, single dose, oral administration
16062258|NCT02438683|Drug|Placebo|single dose, oral administration
16062259|NCT02438670|Device|PID control algorithm|
16062260|NCT02438670|Device|MPC control algorithm|
16062261|NCT02438657|Procedure|median nerve block|
16062262|NCT02438618|Procedure|Surgery for Ponto bone anchored hearing aids|
16062263|NCT02438605|Device|Nellix|
16062264|NCT02438579|Other|Nasal Irrigation & Gargling|Participants are advised to perform the intervention as frequently as required (expected frequency around 6 times a day for the first two days, reducing in frequency from day 3 as symptoms improve).
16062265|NCT02438566|Drug|Tranexamic Acid (Oral)|OTA will be given as 1950 mg 1-2 hours prior to OR and 1950 mg 2 hours after surgical close, before discharge from PACU.
16062266|NCT02438566|Drug|Tranexamic Acid (Intravenous)|IVTA will be given as 1 g intravenously at time of first incision (THA or bTKA without tourniquet) or just before 1st tourniquet application (bTKA), and then again, 1 g after final surgery closure.
16062267|NCT02438553|Device|OSTNS Neurostimulator|Non-invasive transcutaneous neurostimulation.
16062268|NCT02438553|Device|Placebo OSTNS Neurostimulator|Placebo non-invasive transcutaneous neurostimulation
16062269|NCT02438540|Drug|metformin|metformin tablet 500 mg
16062270|NCT02438540|Other|acupuncture|Electro body acupuncture and auricular acupuncture
16062271|NCT02438527|Behavioral|Chart for CPR guidance|
16062272|NCT02438514|Other|Biological Sample Collection|"Anthropomorphic biomarkers including height, weight, heart rate, and blood pressure will be taken for each participating mother and child by a research assistant trained to accurately perform these procedures.
~Blood spots will be collected in finger stick proficiency, using trigger activated lancets to administer finger sticks.
~Each participating mothers and child will provide a saliva sample using Oragene DNA saliva collection kits"
16062273|NCT02438501|Radiation|Low-dose involved-field radiotherapy|Low-dose involved-field RT (LD-IFRT) is given in 2 daily fractions (2×2 Gy). Involved-field of radiotherapy defined by CALGB is encompassed the prechemotherapy gross tumor.
16062274|NCT02438501|Radiation|Involved-field radiotherapy|Involved-field RT (IFRT) is given in 24 Gy in 12 fractions. Radiotherapy field defined by CALGB is encompassed the prechemotherapy gross tumor.
16062275|NCT02438475|Device|Mynx Vascular Closure System|MynxGrip is being used to seal femoral vein access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5F, 6F or 7F procedural sheath.
16062276|NCT02438475|Other|Manual Compression|manual pressure applied to your groin for approximately 5-10 minutes
16062277|NCT02438462|Other|Soluble Fibrin|Calculating the area under the ROC curve of the Soluble Fibrin assay for the diagnosis of PE before evaluating the diagnostic performance of the assay.
16062278|NCT02438449|Procedure|Breast Reconstruction Surgery|AAT-based orTE/I reconstruction in all patients undergoing breast reconstruction following mastectomy
16062279|NCT02438436|Dietary Supplement|simo decoction|
16062280|NCT02438436|Other|gum chewing|
16062281|NCT02438423|Biological|Inactivated influenza vaccine|Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
16062282|NCT02438423|Other|Placebo|
16062283|NCT02438397|Drug|premix insulin|Premix-insulin(human insulin or analog) treatment will continue
16062284|NCT02438397|Drug|metformin|500 mg tid by Merck
16062285|NCT02438397|Drug|Acarbose|100mg tid by Bayer
16062286|NCT02438384|Behavioral|Video|This is a 10 minute interactive video which provided information to the viewer regarding the safe and effective use of analgesics for acute musculoskeletal pain at home. The focus is on acetaminophen, NSAIDs, and opioids.
16062287|NCT02438384|Behavioral|Phone follow-up|The call will be made by the study coordinator, who is a medical student. Any patients reporting a pain score in the past 24 hours of 4 or more will be re-contacted by an emergency physician with special training in geriatric pain management. This individual will provide recommendations to the patient regarding treatment options.
16062288|NCT02438371|Drug|Nifedipine|Nifedipine will be given for the treatment of preterm labor
16062289|NCT02438371|Drug|Indomethacin|Nifedipine and indomethacin will be give for the treatment of pretermlabor
16062290|NCT02438358|Drug|LUM015|
16062291|NCT02438358|Device|LUM 2.6 Imaging Device|
16062292|NCT02438345|Biological|PRO 140|Humanized monoclonal antibody to CCr5
16062293|NCT02438332|Device|Smooth NATRELLE® INSPIRA® TruForrm® 1 Breast Implants|Surgical implant
16062294|NCT02438332|Device|Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants|surgical implant
16062295|NCT02438332|Device|Smooth NATRELLE® INSPIRA® TruForrm® 2 Breast Implants|surgical implant
16062296|NCT02438332|Device|Textured NATRELLE® INSPIRA® TruForm® 1 Breast Implants|surgical implant
16062297|NCT02438319|Other|manual planimetry|Manually marking of the boundaries of the optic disc and it's excavation on color photographs of the optic disc.
16062298|NCT02438319|Other|automated planimetry|Automatic detection of the boundaries of the optic disc and it's excavation on color photographs of the optic disc.
16062299|NCT02438306|Biological|Autologous cell therapy|Autologous cell therapy delivered into the heart muscle using the CardiAMP Cell Therapy System. The CardiAMP Cell Therapy System consists of the CardiAMP Cell Separator, a cardiac delivery catheter, and flexible tip guide catheter.
16062300|NCT02438306|Other|Sham|An introducer guidewire is placed into the heart and left ventriculography is performed just like it is in the Experimental Arm but no autologous cell therapy is delivered.
16062301|NCT02438293|Other|rhinovirus diagnostics|rhinovirus PCR on a nasopharyngeal swab
16062302|NCT02438280|Device|AcceleDent, Vibrational Device|20 minutes of vibration each day
16062303|NCT02438241|Procedure|Conventional physiotherapy Group|Patients randomized to this group will receive only conventional physiotherapy. The treatment protocol Control Group, will consist of weathered active exercises to manually lower limbs in bed (triple flexion, abduction and adduction, plantar / dorsiflexion), free active exercises of the upper limbs in the bed (shoulder flexion, shoulder flexion and horizontal functional diagonal shoulder), bronchial hygiene techniques, flow redirection, positive expiratory pressure and ventilatory blowing patterns.
16062304|NCT02438241|Procedure|TENS Group|Patients randomized to this group will receive conventional physical therapy (the treatment protocol Control Group), and the end of that service, will be applied TENS. TENS is accomplished through the use of an electrical stimulation device with symmetrical biphasic current pulse. The following parameters are used: frequency: 100 Hz, pulse width: 100 µs, intensity to the greatest sensory threshold of the patient and total session time: 30 minutes. Self-adhesive electrodes will be used (Valutrode, size 5x9 cm) to be positioned in the posterolateral portion of the chest to 2 cm skin incision both upper and lower.
16062305|NCT02438241|Procedure|Placebo TENS group|Patients randomized to this group will receive conventional physical therapy (the treatment protocol Control Group), will be held the same procedure as TENS group, except that TENS will be offered to the patient only for 45 seconds, and in the first 30 seconds is reached the sensory threshold of the patient and in the last 15 seconds will turn off the electrical current by 29 remaining period minutes and 15 seconds off.
16062306|NCT02438228|Other|Cardiac output measurement|Measurement of cardiac output by transpulmonary thermodilution, nine different pulse contour algorithms and esophageal doppler before, during and after a PLR-maneouvre and every 10 minutes before and after cardiopulmonary Bypass.
16062307|NCT02438215|Drug|IRX4204|IRX4204 is a potent and highly selective orally available and brain penetrant RXR nuclear receptor agonist small compound administered as gel capsules.
16062308|NCT02438202|Device|Thymatron IV device (Somatics)|Patients will be treated with a modified routine ECT/maintenance ECT series.
16062309|NCT02438189|Device|Hyperglycemia Minimization Algorithm|The hyperglycemia minimization algorithm will be running actively on the study laptop during the night and dose insulin if the algorithm predicts hyperglycemia. If hypoglycemia is predicted, the system will suspend the pump.
16062310|NCT02438176|Procedure|single trans-septal puncture|The investigators will compare bilateral groin puncture AF ablation and single groin puncture AF ablation with 1:2 randomization.
16062311|NCT02438176|Procedure|conventional bilateral groin puncture|Bilateral groin puncture AF ablation is control procedure exactly same to routine AF ablation with double trans-septal puncture.
16062312|NCT02438163|Device|Theta Burst Stimulation|"During the first session, After determining the parameters of stimulation (stimulated target : part of the left motor cortex responsible for the contraction of the right first dorsal interosseous muscle ; Activity Motor Threshold (AMT) ; Intensity of Stimulation providing a Motor Evoked Potential (MEP) with an Amplitude of 1mV (MEP 1mV)), a Baseline consisting of 15 MEP (intensity MEP 1mV) is measured. Then each subjet receive a TBS protocol (cTBS or iTBS) (intensity of stimulation 80% of AMT). After receiving the stimulation, sets containing 10 MEP are regularly measured by each subject.
~During a second session, the same protocol is done again with the other TBS stimulation (cTBS or iTBS) the subject didn't get during the first session."
16062313|NCT02438150|Behavioral|Hospital fire video training|Participants will watch a video about hospital fire training which last for 30 minutes
16062314|NCT02438150|Behavioral|Non hospital fire video training|Participants will watch a video about volcanic eruption which last for 30 minutes
16062315|NCT02438137|Drug|Dimethyl fumarate|Dimethyl fumarate capsules will be dispensed during routine study appointments. 120 mg tablets will be dispensed to facilitate dose titrations. Drug will be dispensed in 1 month supply, so that compliance can be reconciled at monthly follow-up visits, and recorded in accountability logs. Participants will be instructed to take the medication with food, in the morning and at dinnertime. If participants miss a dose, they will be instructed to resume their normal dose at the next scheduled time, and be instructed not to take an extra dose at their next dosing interval if they previously miss a dose.
16062316|NCT02438137|Drug|Placebo|Placebo capsules will be dispensed during routine study appointments. Placebo will be dispensed in 1 month supply, so that compliance can be reconciled at monthly follow-up visits, and recorded in accountability logs. Participants will be instructed to take the placebo with food, in the morning and at dinnertime. If participants miss a dose, they will be instructed to resume their normal dose at the next scheduled time, and be instructed not to take an extra dose at their next dosing interval if they previously miss a dose.
16062317|NCT02438124|Behavioral|Neuropsychological evaluation|The subjects are submitted in one hearing stimulus while they realize a walking test
16062318|NCT02438111|Genetic|metagenome|metagenome
16062319|NCT02438098|Drug|Rivaroxaban 10 mg|Patients receive the day before the surgical intervention the first dose of Rivaroxaban (10 mg) p.o. The second tablet Rivaroxaban is administered on the third postoperative day.
16062320|NCT02438085|Other|prospective collection of data and follow-up|prospective collection of data and follow-up of all patients admitted to hospital for ACS
16062321|NCT02438072|Drug|Omeprazole (10 mg, A02BC01)|The cocktail of drug substrates will be given one time, one day during the study, to explore the activity of CYP 1A2, 2B6, 2C9, 2C19, 3A4, 2D6, and the P-gp
16062322|NCT02438059|Behavioral|SoSu-liv website and app|A 38 weeks web- and app-based tool for lifestyle changes intervention.
16062323|NCT02438046|Procedure|Palatal wound bandage|Treatment of Palatal wounds by Platelet Rich Fibrin or absorbable gelatin sponge.
16062324|NCT02438033|Device|Medtronic Activa PC+S Sensing Deep Brain Stimulator Generator|Patients undergoing deep brain stimulation for Parkinson's disease based on clinically indicated criteria will have the option to enroll in this study, in which the Activa PC+S generator and corresponding extension leads will be implanted rather than the standard Activa PC system. Patients will be assessed every month for 3 months and then every 3 months after, including off and on medication assessments.
16062325|NCT02438020|Drug|Metformin|One tablet of 500 mg will be ingested before the main meal
16062326|NCT02438020|Other|Placebo|A placebo tablet will be ingested daily before main meal.
16062327|NCT02438007|Drug|Galeterone|2550 mg galeterone tablets once daily PO
16062328|NCT02438007|Drug|Enzalutamide|160 mg enzalutamide capsules once daily PO
16062329|NCT02437994|Behavioral|Pulmonary Rehabilitation|The rehabilitation program will be multidisciplinary and will include mandatory supervised exercise training at appropriate training intensity, other components of the program can be breathing control and relaxation techniques, methods of clearance of pulmonary secretions, disease education, dietary advice, and psychological support on issues relating to chronic disability. Six minute walking tests, and improvements in dyspnea sensation (CRDQ) will be used to benchmark the effect of a program provided by a given team.
16062330|NCT02437981|Drug|PrEP|Oral pre-exposure prophylaxis (PrEP) for HIV infection using a daily combination tablet of tenofovir disoproxil fumarate and emtricitabine
16062331|NCT02437968|Behavioral|Camp Cope-A-Lot (Computer-assisted CBT program)|Camp Cope-A-Lot is a computer-assisted program that includes psychoeducation and clinician guided exposure tasks for anxious children.
16062332|NCT02437955|Other|Ferrous sulfate fortified bread with tea|Fasting subjects will be served a wheat roll fortified with labelled ferrous sulfate and stable isotopes
16062333|NCT02437955|Other|ferrous sulfate fortified bread with water|Fasting subjects will be served a wheat roll fortified with labelled ferrous sulfate and stable isotopes
16062334|NCT02437955|Other|Ferrous fumarate fortified bread with tea|Fasting subjects will be served a wheat roll fortified with labelled Fe Fumarate and stable isotopes
16062335|NCT02437955|Other|Ferrous fumarate fortified bread with water|Fasting subjects will be served a wheat roll fortified with labelled Fe Fumarate and stable isotopes
16062502|NCT02436798|Drug|Ondansetron|All patients will be receiving treatment with ondansetron as part of standard care.
16062336|NCT02437942|Other|Biomechanics led physical therapy rehabilitation|Rehabilitation intervention will consist of movement control (3 days per week), whole body strength and power (2 days per week), linear running mechanics (3 days per week), multi-directional mechanics (3 days per week), conditioning sessions (2 days per week). Rehabilitation will continue until physical therapist deems the athlete ready to return to sport.
16062337|NCT02437929|Procedure|Mobilization|
16062338|NCT02437929|Procedure|Positioning|
16062339|NCT02437929|Procedure|Personal Hygiene Care|
16062340|NCT02437929|Procedure|Bladder catheterization|
16062341|NCT02437929|Procedure|Wound care|
16062342|NCT02437929|Procedure|Subcutaneous drugs administration|
16062343|NCT02437916|Drug|AMG 228|AMG 228 will be administered intravenously
16062344|NCT02437903|Device|JUVÉDERM VOLUMA™ XC|Subjects will receive up to 4, 1mL syringes of JUVÉDERM VOLUMA™ XC for their initial injection and a maximum of 6, 1mL syringes of JUVÉDERM VOLUMA™ XC for the study. Subjects will undergo one touch-up injection approximately 2 weeks post initial treatment, and will continue to be evaluated at month 1, month 3, month 6, month 9, and month 12.
16062345|NCT02437890|Biological|ALX-0061|
16062346|NCT02437890|Biological|Placebo|
16062347|NCT02437864|Device|Supplemental oxygen via nasal cannula|
16062348|NCT02437851|Procedure|Therapeutic Conventional Surgery|Undergo surgery to remove anal or perianal cancer (SISCCA)
16062349|NCT02437838|Other|No Intervention|No Intervention
16062350|NCT02437825|Drug|octreotide|Octreotide has been in clinical use for thirty years and approved for use in Israel in acromegaly and functional gastroenteropancreatic tumours. It is currently being used extensively in surgical patients to prevent pancreatic fistulae1, and in lymphorrhea (both lymphatic malformations and leaks from the thoracic duct)
16062351|NCT02437825|Other|placebo|placebo ( saline) act as comperator in this study.
16062352|NCT02437812|Drug|Metformin|Metformin with standard chemotherapy
16062353|NCT02437812|Drug|Paclitaxel|Standard chemotherapy
16062354|NCT02437812|Drug|Carboplatin|Standard chemotherapy
16062355|NCT02437799|Other|Dicrotic wave analysis|We will download data from the pulse oximeter that is being used to monitor the patient during their surgery.
16062356|NCT02437786|Drug|GRAZAX|GRAZAX
16062357|NCT02437773|Behavioral|Cognitive Behavioral Therapy - Adolescents|"A therapy which gradually yet repeatedly exposes adolescent patients to their obsessive compulsive-relevant error cues during a task performance until their anxiety habituates."
16062358|NCT02437773|Behavioral|Stress Management Therapy - Adolescents|An active control therapy with minimal effects on OCD symptoms.
16062359|NCT02437773|Behavioral|Optional CBT - Adolescents|This is the cross-over element for those that completed the SMT treatment group and opt to have the OCD treatment.
16062360|NCT02437773|Behavioral|Cognitive Behavioral Therapy - Adults|"A therapy which gradually yet repeatedly exposes adult patients to their obsessive compulsive-relevant error cues during a task performance until their anxiety habituates."
16062361|NCT02437773|Behavioral|Stress Management Therapy - Adults|An active control therapy with minimal effects on OCD symptoms.
16062362|NCT02437773|Behavioral|Optional CBT - Adults|This is the cross-over element for those that completed the SMT treatment group and opt to have the OCD treatment.
16062363|NCT02437773|Other|fMRI only - Healthy Control Adults|Two fMRI's only, scheduled at 12-weeks apart. This is for Healthy Control Adults and is used only as a means for observation, NOT as an intervention to be studied.
16062364|NCT02437773|Other|fMRI only - Healthy Control Adolescents|Two fMRI's only, scheduled at 12-weeks apart. This is for Healthy Control Adolescents and is used only as a means for observation, NOT as an intervention to be studied.
16062365|NCT02437760|Other|serum and pleural effusion CA-125 level|"serum and pleural effusion(if exist) CA-125 are collected:
~at time of diagnosis
~every 3 month during treatment
~stop at the progression or after 12 months"
16062366|NCT02437747|Drug|SRP + Aloe|Scaling and root planing along with aloe vera application was done
16062367|NCT02437747|Procedure|SRP|Scaling and root planing was done
16062368|NCT02437734|Procedure|Percutaneous Coronary Intervention|A phase II, observational, analytical study of coronary angiography and computational fluid dynamics in 100 adults with coronary artery disease undergoing coronary angiography.
16062369|NCT02437721|Other|infant formula containing folic acid|
16062370|NCT02437721|Other|infant formula containing MTHF|
16062371|NCT02437708|Procedure|REP with L-PRF|
16062372|NCT02437708|Procedure|REP|
16062373|NCT02437708|Biological|stem and progenitor cells|
16062374|NCT02437669|Drug|Hydromorphone|To be administered by intranasal route using mucosal atomization device.
16062375|NCT02437656|Drug|Metformin|"J3 - J10 (7 days minimum) : 850 mg 2 times / day
~J10 - 48h before surgery : 850 mg 3 times / day"
16062376|NCT02437643|Behavioral|Weight Loss|Participants will be prescribed hypo-caloric diet prescription.
16062377|NCT02437643|Dietary Supplement|Dairy Protein|Participants will be provided dairy products: WL-LoEx will be provided 1 dairy serving per day and Pro-WL-LoEx will be provided 8 dairy servings per day.
16062378|NCT02437643|Behavioral|Low intensity exercise|Participants in both groups will participate in chair exercises 3 times a week.
16062379|NCT02437630|Procedure|Oesophageal balloon to measure intra-thoracic pressure|An oesophageal balloon will be inserted via a nostril after instillation of local anaesthetic and swallowed until the tip is in the lower third of the oesophagus. This will allow the intrathoracic pressure to be monitored via a pressure sensor attached to the oesophageal balloon catheter and placed next to the subject. This will allow us to observe the changes in oesophageal pressure during quiet breathing under a variety of applied positive pressure conditions.
16062380|NCT02437630|Procedure|Fibre-optic laryngoscopy|A fibre-optic laryngoscope will be inserted through the opposite nostril to that used for the oesophageal balloon and placed with its tip abve the larynx where the laryngeal movement can be observed This will allow us to observe the changes in laryngeal aperture under a variety of applied positive pressure conditions.
16062381|NCT02437630|Other|standard lung function tests|These will be carried out in any subject who has not had lung function testing in the previous 6 weeks and will be carried out by a lung function physiologist from the institution in accordance with standard procedures for lung function testing
16062382|NCT02437630|Procedure|face mask CPAP|The subjects will wear a facemask with apertures for the oesophageal balloon and fibre-optic devices to cover the mouth and nose. airflow and volume will be recorded with a pneumotachograph and there will be tubing to connect to a positive pressure source (CPAP) to allow mouth pressures to be altered between 0-15cm H20.( 1cm H20 is the pressure produced by a column of water of 1centimetre in depth)
16062383|NCT02437630|Procedure|variation of mouth pressure with CPAP|Once the other procedures are completed the subject will have his mouth pressure varied via application of positive pressure via a commercial CPAP device as used for treatment of obstructive sleep apnoea. The pressure will be varied randomly between 0-15cm H2O (water)for periods of 5 minutes both sitting and lying. Oesophageal balloon recording of intra-thoracic pressure and laryngeal movement and mouth airflow and volume will be recorded simultaneously and at the end of each 5 minute period the subject will be requested to take as big a breath in as possible to allow measurement of functional residual capacity and inspiratory capacity. This will allow us to observe the effect of changing mouth pressure with CPAP on laryngeal aperture and oesophageal pressures and airflow.
16062384|NCT02437630|Other|facemask pneumotachograph|The facemask will incorporate a pneumotachograph to allow measurement of airflow and volumes throughout the respiratory cycle. This will allow us to observe the pattern of airflow with varying applied CPAP
16062385|NCT02437617|Procedure|Tumor Tissue|Tumor tissue collected previously from surgery or a prior biopsy (archived tissue) used for genetic testing.
16062386|NCT02437604|Drug|Treatment A: Fp MDPI|Fp MDPI 200 mcg, 1 inhalation
16062387|NCT02437604|Drug|Treatment B: FS MDPI|FS MDPI 200/12.5 mcg, 1 inhalation
16062388|NCT02437604|Drug|Treatment C Flovent|FLOVENT DISKUS 250 mcg, 2 inhalations
16062389|NCT02437604|Drug|Treatment D: Advair|ADVAIR DISKUS 500/50 mcg, 1 inhalation
16062390|NCT02437591|Drug|fidaxomicin|oral
16062391|NCT02437565|Other|Stainless steel crown|Placement of stainless steel crowns for teeth that have undergone pulpotomy for the treatment of pulpitis induced by severe early childhood caries under general anesthesia
16062392|NCT02437565|Other|Occlusal Template|Use of an occlusal template for the placement of stainless steel crowns under general anesthesia
16062393|NCT02437552|Device|ergometer cycle exercise|
16062394|NCT02437552|Other|routine physiotherapy|routine physiotherapy
16062395|NCT02437539|Drug|Injection of 68Ga-NOTA-AE105|One injection of 68Ga-NOTA-AE 105
16062396|NCT02437539|Device|Positron Emission Tomography scans|Following injection of 68Ga-NOTA-AE105 the patients will be PET scanned at 10 minutes, 1 hour and 2 hours post injection
16062397|NCT02437526|Other|Analytic treatment interruption|
16062398|NCT02437513|Device|NewBreez|Intralaryngeal prosthesis to protect the airways
16062399|NCT02437500|Drug|SER-109|SER 109 is a rationally designed ecology of bacterial spores enriched from stool donations obtained from healthy, screened donors.
16062400|NCT02437487|Drug|SER-109|SER 109 is a rationally designed ecology of bacterial spores enriched from stool donations obtained from healthy, screened donors.
16062401|NCT02437487|Drug|Placebo|Placebo will be identical to the investigator product but will not contain product spores or non-spore solids. Placebo will consist of 92% glycerol and 8% normal saline.
16062402|NCT02437474|Behavioral|Omnivorous diet|Adopting or continuing the selected diet for 6 months (omnivorous)
16062403|NCT02437474|Behavioral|Lacto-ovo-vegetarian diet|Adopting or continuing the selected diet for 6 months (lacto-ovo-vegetarian)
16062404|NCT02437474|Behavioral|Vegan diet|Adopting or continuing the selected diet for 6 months (vegan)
16062405|NCT02437461|Drug|Triamcinolone hexacetonide|intraarticular knee injection
16062406|NCT02437448|Other|No intervention|
16062407|NCT02437435|Other|Reproductive Technique Gimilio|"Patient supine, legs in triple flexion, feet on table, controlling legs left hand and right hand bent on uterine body contact.
~Both hands catch utero withdrawal into one on another with arms outstretched. Fixed uterus right hand, left hand, with levers legs combines lateroflexion-rotation parameters of lumbar spine to improve uterine ligaments stretch, repeat technique to tissue relaxation. Then perform massage-cranial caudo zigzag with anteroposterior thrust. (overall hemodynamic maneuver). Finally do anteroposterior pumping about uterine body generating positive and negative pressures.
~Hand therapist will keep in touch at all times on the suprapubic region of the patient."
16062408|NCT02437422|Biological|SANGUINATE|Single two-hour infusion of SANGUINATE
16062409|NCT02437409|Device|pREset thrombectomy retriever|Interventional recanalization of acute cerebral vessel occlusions with the pREset thrombectomy system alone or in combination with intravenous or intraarterial thrombolytics (rt-PA).
16062410|NCT02437383|Drug|Propranolol ER|Capsules given orally according to schedule at Visit 1, Visit 2, Visit 3, and Visit 4.
16062411|NCT02437383|Drug|Placebo|Gelatin capsules with a microcrystalline cellulose filler manufactured to mimic propranolol ER 60 mg capsules
16062412|NCT02437370|Drug|Pembrolizumab|Given IV
16062413|NCT02437370|Drug|Docetaxel|Given IV
16062414|NCT02437370|Drug|Gemcitabine Hydrochloride|Given IV
16062415|NCT02437357|Other|Metacognitive Training|8 group sessions á 60 min
16062416|NCT02437357|Other|Positivity Training|8 group sessions á 60 min
16062417|NCT02437344|Drug|CI-581aa|92 minute infusion of CI-581aa
16062418|NCT02437344|Drug|Naltrexone titration and XR-NTX initiation|participants will be provided a titration of naltrexone that culminates in the injection of XR-NTX
16062419|NCT02437318|Drug|Fulvestrant|
16062420|NCT02437318|Drug|Alpelisib|
16062421|NCT02437318|Drug|Alpelisib placebo|
16062422|NCT02437305|Behavioral|ABCDEs of Melanoma Skin Cancer|Modified melanoma educational intervention that is targeted towards people of color.
16062423|NCT02437305|Behavioral|ABCDEs of Melanoma|Conventional melanoma educational intervention.
16062424|NCT02437292|Other|Ischemic compression with stretching|
16062425|NCT02437279|Procedure|Surgery of the tumor|
16062426|NCT02437279|Drug|Infusion with ipilimumab 3 mg/kg q3wks|
16062427|NCT02437279|Drug|Infusion with nivolumab 1 mg/kg q3wks|
16062428|NCT02437266|Other|Scapular mobilization|
16062429|NCT02437253|Drug|Adalimumab|Subjects will be treated with adalimumab (20 mg [weight 15-<30 kg] or 40 mg [weight ≥30 kg] administered subcutaneously [subQ] every other week) or placebo for 16 weeks, then cross-over to the other group for 16 weeks.
16062431|NCT02437240|Behavioral|Pilates-based CPT|To emphasize the self-perception of breathing and body core control during in-patient cardiopulmonary physical therapy following cardiac surgery
16062432|NCT02437240|Behavioral|Traditional CPT|A traditional in-patient cardiopulmonary physical therapy following cardiac surgery including airway clearance, breathing exercises, chest mobility and reconditioning exercises and so on
16062433|NCT02437227|Drug|CCT3833|CCT3833 is a poorly soluble crystalline compound. It is multi-polymorphic and one form, designated Form D, has been purified and typically has a particle size of about 15-20 μm. Form D readily absorbs and desorbs water, but is not a hydrate and has been selected as the form to take forward into clinical development.
16062434|NCT02437214|Other|Use of music for anxiety in children|"The Baby Go to Sleep CD played a combination of the sound of an actual human heartbeat and children's songs. The concept behind the Baby Go to Sleep CD is to blend heart beat sounds, which are known to be calming to infants and children, with children's music. The basic principles of relaxation were incorporated in the arrangements of heartbeat and children's songs, ie: simplicity, repetition, predictability, and simple symmetry (short repeated patterns). The adult human heart in the Baby Go to Sleep CD was recorded from the chest and set in consistent tempos for each song ranging from 62 to 78 beats per minute(BPM). The sound of the heartbeat continued between and during songs. Tempo changes occurred between each song."
16062435|NCT02437201|Behavioral|Liberty Program|
16062436|NCT02437188|Behavioral|ACT (Acceptance and Commitment Therapy)|The 1-day training session with ACT proposed for this study is designed to reduce behavioral avoidance and to enhance acceptance-based coping. The intervention includes: 1) Behavioral Change Training (2.5 hours) involving a) teaching patients how to recognize ineffective patterns of behavior and habits, b) exploring and setting life goals and goals related to mental and physical health, and c) promoting effective and committed actions to achieve these goals despite the urge to do otherwise; 2) Acceptance and Mindfulness Training (2.5 hours) emphasizing new ways of managing troubling thoughts, feelings, and physical sensations (e.g., learning how to recognize, and develop cognitive distance from, unhelpful thoughts and learning how to willingly face experiences that cannot be changed.
16062437|NCT02437175|Dietary Supplement|ENDO 1/ENDO 2|NUTRI ENDO 1 (1 sequence of 10 tablets on the morning) and NUTRI ENDO 2 ( sequence of 10 tablets at the evening), daily, during 120 days.
16062438|NCT02437175|Dietary Supplement|Placebo|Placebo: 1 sequence of 10 tablets on the morning and 1 sequence of 10 tablets at the evening, daily, during 120 days.
16062439|NCT02437162|Drug|Placebo|Participants will receive Placebo subcutaneous (SC) injection at Weeks 0, 4, and 16 in Group 1 and at Week 24 in Group 2 and Group 3.
16062440|NCT02437162|Drug|Ustekinumab 45 mg|Participants will receive Ustekinumab 45 mg SC injection at Weeks 24 and 28 followed by every 12 weeks (q12w) dosing, with the last administration of study agent at Week 100 in Group 1. Participants will start with ustekinumab 45 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 100 in Group 2.
16062441|NCT02437162|Drug|Ustekinumab 90 mg|Participants will receive Ustekinumab 90 mg SC injection at Weeks 24 and 28 followed by q12w dosing, with the last administration of study agent at Week 100 in Group 1. Participants will start with ustekinumab 90 mg SC injection at Weeks 0 and 4, followed by q12w dosing, with the last administration of study agent at Week 100 in Group 3.
16062442|NCT02437162|Drug|Golimumab 50 mg|Participants who meet EE criteria (less than [<] 10 percent [%] improvement from baseline in both total back pain and morning stiffness measures at both Week 12 and Week 16) will be administered open-label golimumab 50 mg SC administrations at Week 16 and every 4 weeks (q4w) thereafter through Week 52 in Groups 1, 2 and 3.
16062443|NCT02437149|Behavioral|Video|Real stories video presentation about distracted driving. Produced by the National Highway Traffic Safety Administration.
16062444|NCT02437149|Behavioral|Power Point|Brief power point presentation with information about distracted driving. Produced by the National Highway Traffic Safety Administration.
16062445|NCT02437149|Behavioral|Brochure|Brochure with the National Highway Traffic Safety Administration information about distracting driving.
16062446|NCT02437136|Drug|entinostat|An orally available histone deacetylases inhibitor (HDACs)
16062447|NCT02437136|Drug|pembrolizumab|A selective humanized monoclonal antibody (mAb)
16062448|NCT02437123|Behavioral|The Cedar Project mHealth intervention|
16062449|NCT02437110|Drug|Darunavir|Orally-administered medication approved for HIV treatment. MOA is as a protease inhibitor. Dose is 600mg twice daily.
16062450|NCT02437110|Drug|Ritonavir|Orally-administered, FDA-approved medication for HIV treatment. Used in combination with darunavir. Dose is 100 mg twice daily.
16062451|NCT02437110|Drug|Dolutegravir|Orally-administered, FDA-approved medication to treat HIV. It acts as an integrase inhibitor. Dose is 50 mg once daily.
16062452|NCT02437110|Drug|Tenofovir alafenamide (TAF)|Orally-administered, FDA-approved medication used to treat HIV. It acts as a nucleoside reverse transcriptase inhibitor. Dose is 25 mg once daily.
16062453|NCT02437097|Other|Aerobic exercise|The research design used will be a randomized control trial using a Latin square in order to randomize the treatment conditions. Subjects will take one of four conditions: 1) Aerobic exercise only 2) Aerobic exercise and Gaming simultaneously 3) Gaming only 4) Sitting quietly. All the conditions will take 30 minutes. The independent variables are the four conditions and the dependent variables are the Stroop test and modified Trails B which measure executive function.
16062454|NCT02437097|Other|Video Gaming|The research design used will be a randomized control trial using a Latin square in order to randomize the treatment conditions. Subjects will take one of four conditions: 1) Aerobic exercise only 2) Aerobic exercise and Gaming simultaneously 3) Gaming only 4) Sitting quietly. All the conditions will take 30 minutes. The independent variables are the four conditions and the dependent variables are the Stroop test and modified Trails B which measure executive function.
16062455|NCT02437097|Other|Aerobic exercise and Video Gaming|The research design used will be a randomized control trial using a Latin square in order to randomize the treatment conditions. Subjects will take one of four conditions: 1) Aerobic exercise only 2) Aerobic exercise and Gaming simultaneously 3) Gaming only 4) Sitting quietly. All the conditions will take 30 minutes. The independent variables are the four conditions and the dependent variables are the Stroop test and modified Trails B which measure executive function.
16062501|NCT02436811|Behavioral|Control|60 women aged between 12 and 50 and gestational period until 32nd weeks.The control group will receive a leaflet on oral cancer.
16062456|NCT02437097|Other|Control|The research design used will be a randomized control trial using a Latin square in order to randomize the treatment conditions. Subjects will take one of four conditions: 1) Aerobic exercise only 2) Aerobic exercise and Gaming simultaneously 3) Gaming only 4) Sitting quietly. All the conditions will take 30 minutes. The independent variables are the four conditions and the dependent variables are the Stroop test and modified Trails B which measure executive function.
16062457|NCT02437084|Drug|Atorvastatin|Study subjects will receive atorvastatin 40 mg for 10 weeks.
16062458|NCT02437071|Drug|Pembrolizumab|Pembrolizumab will be administered as a 30 minute IV infusion (every effort should be made to target infusion timing to be as close to 30 minutes as possible. However, given the variability of infusion pumps from site to site, a window of -5 minutes and +10 minutes is permitted (i.e., infusion time is 30 minutes: -5 min/+10 min).
16062459|NCT02437071|Radiation|Radiotherapy|
16062460|NCT02437071|Procedure|Radiofrequency ablation|
16062461|NCT02437058|Other|preidictive model|
16062462|NCT02437045|Drug|Meropenem|Meropenem is a carbapenem anti-bacterial used for the treatment of serious infections in patients.
16062463|NCT02437045|Drug|Piperacillin-tazobactam combination product|Piperacillin-tazobactam is used for the treatment of patients with systemic and/or local bacterial infections.
16062464|NCT02437032|Drug|recombinant FSH|Controlled ovarian stimulation with 150-300 UI recombinant FSH
16062465|NCT02437032|Drug|Urinary FSH|Controlled ovarian stimulation with 150-300 UI urinary FSH
16062466|NCT02437032|Drug|hMG|Controlled ovarian stimulation with 150-300 UI hMG
16062467|NCT02437019|Drug|PCI-32765 (Ibrutinib)|Participants will receive PCI-32765 (ibrutinib) 420 mg (three 140-mg capsules) oral once daily continuously on a 28-day cycle.
16062468|NCT02437006|Other|exercise|cycle ergometry
16062469|NCT02436993|Drug|Carboplatin|Area Under the Curve (AUC) 2 IV over 60 minutes weekly for 12 doses
16062470|NCT02436993|Drug|Paclitaxel|80 mg/m^2 IV over 1-3 hours weekly for 12 doses
16062471|NCT02436993|Drug|Bevacizumab|10mg/kg IV over 90 or 60 or 30 minutes every other week for 5 doses
16062472|NCT02436993|Drug|Trastuzumab|4mg/kg induction, followed by weekly 2mg/kg IV-induction over 90 minutes, then weekly over 30-60 minutes for 12 doses
16062473|NCT02436993|Drug|Pertuzumab|840mg induction, followed by 420mg every 3 weeks IV-induction over 60 minutes, then every 3 weeks over 30-60 minutes for 4 doses
16062474|NCT02436980|Drug|Tramadol|GROUP T
16062475|NCT02436980|Drug|Midazolam|GROUP M
16062476|NCT02436967|Other|Carotid endarterectomy in clinical healthcare.|For the this study itself there is no intervention caused by the extra CT or MRI. The patients are scheduled for surgery as the routine intervention to reduce the risk of a new stroke in clinical practice. The performed extra diagnostic CT and MRI in this study before surgery will compare the vessel wall images with histology regardless of the patients status or medication.
16062477|NCT02436954|Procedure|CO2 insufflation at intra-abdominal pressure 8 mmHg|insufflation of CO2 gas into peritoneum for maintaining the pressure of 8 mmHg
16062478|NCT02436954|Procedure|CO2 insufflation at intra-abdominal pressure 12 mmHg|insufflation of CO2 gas into peritoneum for maintaining the pressure of 12 mmHg
16062479|NCT02436941|Radiation|Proton or Photon|
16062480|NCT02436928|Biological|AT-501 High Dose vaccine|Comparison of each dose of vaccine
16062481|NCT02436928|Biological|AT-501 High Dose vaccine with Adjuvant|Comparison of each dose of vaccine
16062482|NCT02436928|Biological|AT-501 Low Dose vaccine|Comparison of each dose of vaccine
16062483|NCT02436928|Biological|AT-501 Low Dose vaccine with Adjuvant|Comparison of each dose of vaccine
16062484|NCT02436915|Other|Real tDCS|Transcranial direct current stimulation (tDCS) enables noninvasive, selective and sustained modulation of cortical activation. tDCS works by sending low-level currents between two or more scalp electrodes, which alters brain polarity and thus, perfusion and cortical excitability.
16062485|NCT02436915|Other|Sham tDCS|For sham tDCS, current will only be applied for the first 60 seconds of each 20 minute session. This is a reliable sham control as sensations arising from tDCS diminish considerably after the first minute of stimulation.
16062486|NCT02436902|Procedure|TACE|TACE is performed one month after resection.
16062487|NCT02436902|Drug|Sorafenib|Sorafenib is submitted one month after resection.
16062488|NCT02436902|Drug|TACE plus sorafenib|TACE plus sorafenib will be submitted one month after resection.
16062489|NCT02436902|Other|empty control|This group will not receive adjuvant therapy.
16062490|NCT02436889|Drug|Mirabegron|
16062491|NCT02436889|Drug|Tolterodine Tartrate|
16062492|NCT02436876|Drug|MBN-101|MBN-101 is a locally administered, anti-infective drug product
16062493|NCT02436876|Other|Placebo|The placebo is comprised of the vehicle/excipients used to formulate MBN-101, but does not contain the active pharmaceutical ingredient
16062494|NCT02436863|Procedure|Surgical performance|Two different surgical performances
16062495|NCT02436850|Procedure|Thoracentesis|An invasive procedure to remove fluid or air from the pleural space for diagnostic or therapeutic purposes.
16062496|NCT02436837|Other|sessions with virtual reality|sessions with virtual reality to improve the balance
16062497|NCT02436824|Drug|AB001 patch|Two AB001 patches will be applied to the low back once daily for 14 days, the patches shall be removed after approximately 12 hours after daily application.
16062498|NCT02436824|Other|Placebo patch|Two placebo patches will be applied to the low back once daily for 14 days, the patches shall be removed after approximately 12 hours after daily application.
16062499|NCT02436811|Behavioral|Written form instruction|60 women aged between 12 and 50 and gestational period of up to 32nd weeks. Participants in writing intervention will receive a brochure containing information on diet and oral health. This leaflet was produced in accordance with the recommendations of the Ministry of Health regarding eating habits for children under two years (BRAZIL, 2002) and according to the Health Book of the Child: Growth and Development (BRAZIL, 2012).
16062500|NCT02436811|Behavioral|Standardized oral instruction|60 women aged between 12 and 50 and gestational period of up to 32nd weeks. A trained individual will present the same information arranged in the educational brochure in the intervention group on standardized oral form. This examiner will be trained in a unified way in relation to the instructions available in the form of written guidance. Thus, the only difference between the two measures is the interaction between the participant and researcher orally.
16062503|NCT02436785|Other|Music Therapy|In-vivo relaxation where the live music is manipulated in terms of speed and intensity to bring on a state of relaxation for approximately an hour. There will be a brief therapist-led discussion before and after the relaxation portion to increase a sense of group cohesion. Procedures that will be used are based on evidence-based practice for trained Music Therapists.
16062504|NCT02436785|Other|Music Listening|Listening to relaxing music on a CD player for approximately an hour.
16062507|NCT02436733|Procedure|pleurectomy/decortication|Lung sparing procedures consist of the resection of the pleura without removing the lung
16062508|NCT02436733|Drug|Pemetrexed/Cisplatin|On day 1 of each cycle, pemetrexed 500 mg/m2 should be administered as IV infusion followed by cisplatin 75 mg/m2 as IV.
16062509|NCT02436707|Drug|Ibrutinib|
16062510|NCT02436707|Drug|Rituximab|
16062511|NCT02436707|Drug|Gemcitabine|
16062512|NCT02436707|Drug|Dexamethasone|
16062513|NCT02436707|Drug|Cisplatin|
16062514|NCT02436707|Drug|Mesna|
16062515|NCT02436707|Drug|Cyclophosphamide|
16062516|NCT02436707|Drug|Etoposide|
16062517|NCT02436707|Drug|G-CSF|
16062518|NCT02436707|Drug|Selinexor|
16062519|NCT02436694|Drug|Local Anesthetic ropivacaíne|Femoral and sciatic nerve block with ropivacaíne
16062520|NCT02436694|Drug|Perineural Dexamethasone|Addition of perineural dexamethasone to local anesthetic for femoral and sciatic nerve block
16062521|NCT02436681|Device|MIROMESH|
16062522|NCT02436668|Drug|Ibrutinib|
16062523|NCT02436668|Drug|Gemcitabine|
16062524|NCT02436668|Drug|Nab-paclitaxel|
16062525|NCT02436655|Procedure|surgical aortic valve replacement|open heart aortic valve replacement
16062526|NCT02436642|Device|AVERT Plus System|
16062527|NCT02436629|Dietary Supplement|Nitrate-rich concentrated beetroot juice|James White, Beet It Sport Shot, 70ml (Standard)
16062528|NCT02436629|Dietary Supplement|Nitrate-depleted concentrated red beetroot juice|Beet It Sport Shot, 70ml (Placebo)
16062529|NCT02436616|Device|microEEG|"microEEG is a miniature, wireless, and battery-powered EEG device used to obtain EEG recording in challenging environment. All infants have an initial EEG at study enrollment. Follow up microEEGs will be performed at approximately 2-4 week intervals, depending on the Corrected Gestational Age (CGA).
~If ABD events have not resolved at 34 weeks, an 8 hour recording will be performed prior to discharge or at 42 weeks CGA, whichever comes first. EEG will be assessed in 3 hour epochs. The EEG will be reviewed off line by two blinded neurologists and classified as normal or abnormal based on CGA and other findings. Follow up EEGs will be scored similarly, with emphasis on maturation."
16062530|NCT02436603|Behavioral|Nutrition/Mind-Body Coaching|Following the four-week treatment intervention, participants will then be enrolled in an 8-week health coaching follow-up period. During this time participants will have a 45-60 minute telephone session with a health coach weekly for two weeks, then biweekly for four weeks.
16062531|NCT02436590|Device|Orthofix Physio-Stim Model 3315OA|Active device emits PEMF signal; placebo/control device does not emit PEMF signal
16062532|NCT02436577|Drug|Ticagrelor OD tablet (90 mg single dose) administered with 150 mL of water|Ticagrelor 90 mg OD tablet, single dose
16062533|NCT02436577|Drug|Ticagrelor OD tablet (90 mg single dose) administered without water|Ticagrelor 90 mg OD tablet, single dose
16062534|NCT02436577|Drug|Ticagrelor IR tablet (90 mg) administered with 150 mL of water|Ticagrelor 90 mg IR tablet, single dose
16062535|NCT02436564|Genetic|Organoid in vitro culture|Generation of 'organoids' using in vitro culture techniques, genomic DNA and RNA sequencing, application of genome editing technology, investigation of anti-tumour drugs, investigation of biological and functional properties of tumour cells, transplantation of organoid lines into animal models.
16062536|NCT02436551|Other|Observation|
16062537|NCT02436538|Other|Anti Mullerian hormone level; Mullerian duct anomaly type|Diagnosis of Mullerian duct anomaly type Clinically or by Imaging Anti-Müllerian Hormone levels
16062538|NCT02436525|Device|conventional stainless steel orthodontic brackets ligated with stainless steel ligature (Oromco - USA)|
16062539|NCT02436525|Device|passive self-ligating stainless steel orthodontic brackets (Oromco - USA)|
16062540|NCT02436525|Device|active self-ligating stainless steel orthodontic brackets (Oromco - USA)|
16062541|NCT02436512|Drug|Inhaled Nitric Oxide|"The investigational product is inhaled nitric oxide delivered via nasal cannula or venturi mask with the GeNOsylTM Delivery System or GeNOsylTM Acute DS, during RHC as follows:
~(Dose 1): 5 ppm inhaled nitric oxide for 15 minutes
~(Dose 2): 40 ppm inhaled nitric oxide for 15 minutes"
16062542|NCT02436499|Drug|Botulinum Toxin-A|
16062543|NCT02436486|Drug|Placebo|Capsules, orally, single dose
16062544|NCT02436486|Drug|ldalopirdine 120 mg|Two 60 mg encapsulated film-coated tablets, orally, single dose
16062545|NCT02436486|Drug|Idalopirdine 360 mg|Four 90 mg encapsulated film-coated tablets, orally, single dose
16062546|NCT02436486|Drug|Moxifloxacin 400 mg|Encapsulated tablets, orally, single dose
16062547|NCT02436473|Drug|Toothpaste containing 1150ppm F|US marketed toothpaste containing 1150ppm of F
16062548|NCT02436473|Other|Toothpaste containing 0ppm F|Experimental toothpaste containing 0ppm F
16062549|NCT02436473|Drug|Toothpaste containing 250ppm F|Experimental toothpaste containing 250ppm F
16062550|NCT02436473|Drug|Toothpaste containing 1150ppm F|Experimental toothpaste containing 1150ppm F
16062551|NCT02436460|Biological|AbGn-168H|Humanized monoclonal antibody
16062552|NCT02436447|Drug|MTP-131|MTP-131 administered as once-daily 1- hour intravenous infusion for 7 consecutive days in subjects with normal renal function.
16062553|NCT02436447|Drug|MTP-131|MTP-131 administered as once-daily 1- hour intravenous infusion for 7 consecutive days in subjects with mild renal impairment.
16062554|NCT02436447|Drug|MTP-131|MTP-131 administered as once-daily 1- hour intravenous infusion for 7 consecutive days in subjects with moderate renal impairment
16062555|NCT02436447|Drug|MTP-131|MTP-131 administered as once-daily 1- hour intravenous infusion for 7 consecutive days in subjects with severe renal impairment
16062599|NCT02436044|Drug|Leucovorin|Leucovorin, 200mg/m2, intraarterial infusion for 2 hours, on day 1,every 3 weeks
16062556|NCT02436434|Device|pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA)|Intra-articular pulsed radiofrequency (Neurotherm NT1000, Neurotherm Inc., USA) in treated joint
16062557|NCT02436421|Other|Best Practice Alert based in the Electronic Medical Record|
16062559|NCT02436395|Procedure|Group A (povidone-iodine wash the surgical incision)|Gastric cancer patients underwent conventional open D2 total or subtotal gastrectomy and with povidone-iodine wash the surgical incision
16062560|NCT02436395|Procedure|Group B (normal saline wash the surgical incision)|Gastric cancer patients underwent conventional open D2 total or subtotal gastrectomy and with normal saline wash the surgical incision
16062561|NCT02436382|Other|change in temperature|increase in ambient room temperature
16062562|NCT02436369|Dietary Supplement|low fat yogurt enriched with flaxseed|daily intake of low fat yogurt enriched with flaxseed for 8 weeks
16062563|NCT02436369|Dietary Supplement|low fat yogurt|daily intake of low fat yogurt for 8 weeks
16062564|NCT02436356|Device|Osteoprobe-Reference Point Indentation (RPI)|Diagnostic tool used for bone indentation to measure the ability of the tissue to resist microindentation (bone mineral strength).
16062565|NCT02436356|Radiation|Dual-energy X-ray absorptiometry (DXA) Scans|Assessment of Fracture Risk
16062566|NCT02436356|Radiation|MRI|Determines bound water and pore water of bone.
16062567|NCT02436343|Other|echocardiogram|"At each echocardiographic evaluation, the investigator will obtain the following parameters:
~Left ventricular internal dimensions at end diastole Left ventricular posterior wall thickness Left ventricular end systolic stress Left ventricular fractional shortening Velocity of circumferential shortening Left ventricular mass Contractility and indices of preload Stroke volume"
16062568|NCT02436330|Behavioral|Exergaming|"6 months of weight management programming consisting of 10 weekly sessions:1 hour of session was spent exergaming, which included active video game play and traditional group exercises. Some examples include: Dance, Dance, Revolution, Exerbike, Treadwall, Yoga, Spin class, etc."
16062569|NCT02436330|Behavioral|Didactic health teaching|6 months of weight management programming consisting of 10 weekly 1-hour sessions of didactic classes teaching behavioral and dietary curricula. Followed by monthly 1 hour didactic health teaching sessions for the remainder of the 6 month period.
16062570|NCT02436317|Device|Point Of Care Ultrasound|Examination with an ultrasound machine
16062571|NCT02436304|Drug|EXE844 Sterile Otic Suspension, 0.3%|
16062572|NCT02436304|Procedure|Tympanostomy Tube Insertion|Surgical procedure for treating pediatric cases of recurrent or chronic otitis media
16062573|NCT02436291|Device|CURE-EX device|Treatment with CURE-EX device twice daily for 24-30 weeks.
16062574|NCT02436278|Other|4MGS|Usual walking speed measured over 4 metres
16062575|NCT02436265|Drug|Dexamethasone|IV dexamethasone
16062576|NCT02436265|Drug|Ropivacaine|Ropivacaine only
16062577|NCT02436252|Drug|DSP-7888|3.5-10.5 mg/body,Id every 2-4 weeks
16062578|NCT02436239|Drug|Vilazodone|Vilazodone tablets, once daily, oral administration
16062579|NCT02436226|Drug|Clomiphene citrate and Human chorionic gonadotropin (HCG)|Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of cycle) and HCG (200 IU/day SC from day 7 of cycle)
16062580|NCT02436226|Drug|Clomiphene citrate|Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of cycle)
16062581|NCT02436213|Other|Cardiopulmonary exercise test|"On Day 1, subjects will have the test in the Exercise Suite of Hammersmith Hospital, London, UK. They will have painless skin probes placed on their fingers, chest, and legs to monitor heart rate, ECG, blood oxygen levels, and oxygen delivery during the test. Subjects will also be shown how to breathe through a mouthpiece with a nose clip on, and how to indicate on a sliding device whether they feel breathless. They will then start cycling against a very low resistance at a steady speed. As long as they feel comfortable, there will be a gradual increase in work load until they feel they cannot keep going at the same speed. They can also stop sooner for any reason. Afterwards, while they are cooling down (within the hour on Day 1), they will fill in a short questionnaire describing how they feel."
16062582|NCT02436213|Procedure|Blood test|On same day (Day 1), the subject will have 20-30mls of blood (that is, 4-6 teaspoonful) taken for analysis.
16062583|NCT02436200|Device|Neuromuscular Electrical Stimulation|Revitive IX neuromuscular electrical stimulation device will be given to all participants as per protocol.
16062584|NCT02436174|Device|novel device|novel device being used to measure shivering
16062585|NCT02436161|Behavioral|"Care management program PROMIC"|intensive coaching intervention to optimize care and prevent readmissions, using educational selfcare and worsening symptoms recognition by patients and carers
16062586|NCT02436148|Other|Prosthetic for major lower limb amputation|Prosthetic for major lower limb amputee
16062587|NCT02436135|Drug|Idelalisib|Idelalisib tablets administered orally for 24 weeks
16062588|NCT02436135|Drug|Ruxolitinib|Ruxolitinib will be administered per standard of care according to package insert
16062589|NCT02436109|Device|Ultrasound|Parturients backs will be scanned using 3D ultrasound to measure the depth to the epidural space
16062590|NCT02436096|Drug|TNX-102 SL Tablet, 2.8mg|Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.
16062591|NCT02436096|Drug|Placebo SL Tablet|Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.
16062592|NCT02436083|Drug|antibiotic (use of penicilline, unacid, cefuroxime)|prophylactic antibiotics
16062593|NCT02436070|Behavioral|Targeted text messages|Subjects received text messages specific to post ED asthma follow-up
16062594|NCT02436070|Behavioral|General text messages|Subjects received text messages generalized to children with asthma
16062595|NCT02436057|Other|AEGIS (Automated Evaluation of Gastrointestinal Symptoms)|
16062596|NCT02436044|Procedure|HAIC using oxaliplatin plus fluorouracil/leucovorin|Hepatic arterial infusion chemotherapy using oxaliplatin plus fluorouracil/leucovorin
16062597|NCT02436044|Drug|Oxaliplatin|Oxaliplatin, 130mg/m2, intraarterial infusion for 2 hours, on day 1,every 3 weeks
16062598|NCT02436044|Drug|Fluorouracil|Fluorouracil, 1-st.400mg/m2, bolus injection, on day 1,every 3 weeks 2-nd.2400mg/m2, intraarterial infusion for 46 hours, on day 1-2,every 3 weeks
16062600|NCT02436031|Drug|Desipramine|200 mg administered 2 hours before normal sleep time
16062602|NCT02436018|Device|WEI NASAL JET|Oxygen is supplied through WEI NASAL JET by a manual jet ventilator
16062603|NCT02436018|Device|Nasopharyngeal airway without jet ventilator|Oxygen is supplied directly through WEI NASAL JET without jet ventilator
16062604|NCT02436005|Device|Phenacite|Subjects will be randomized to wear the Phenacite contact lenses binocularly.
16062605|NCT02436005|Device|comfilcon A|Subjects will be randomized to wear the comfilcon A contact lenses binocularly.
16062606|NCT02435992|Drug|RPC1063|
16062607|NCT02435992|Drug|Placebo|
16062608|NCT02435979|Other|hand therapy|Treatment can include stretching, motion, and strengthening exercises. As the patients endurance and strength increased the repetitions and/or resistance of these exercises will increase. Modalities for pain control and tissue mobility, and bracing or splinting if necessary. All treatments for the traditional hand therapy treatment group will occur seated at the hand therapy treatment table.
16062609|NCT02435979|Other|Proximal Strengthening|Patients will perform a standardized proximal strengthening protocol consisting of cervical, periscapular, and shoulder strengthening exercises. Depending on the pace and guidance needed for these exercises 25-30 minutes will be spent on proximal strengthening exercises. As the patients endurance and strength increased the repetitions and/or resistance of these exercises will increase.
16062610|NCT02435966|Device|Dry needling|Dry needling of the most active trigger point either in the upper trapezius or the levator scapulae with 40mm x 0,32mm ener-qi guided needles (EQ1132)
16062611|NCT02435966|Device|Sham Dry needling|Sham Dry needling with a retractile needle (Park Sham Placebo Acupuncture Device) of the most active trigger point either in the upper trapezius or the levator scapulae
16062612|NCT02435966|Other|Manual therapy|Standard manual therapy in the upper trapezius or the levator scapulae
16062613|NCT02435953|Procedure|TACE|TACE will be done according to the current method in our center. We use intra-injection of lipiodol mixed with pirarubicin,mitomycin and lobaplatin when the catheter was placed in the superselective location very close to the tumor. Gelfoam sponge was then injected to temporarily occlude the arterial blood flow.
16062614|NCT02435953|Procedure|RFA|For RFA, we used two commercially available system (Cool-Tip, Valleylab，USA) and (Octopus RF Systema，Starmed,Korea）with needle electrode with a 17-gauge internally cooled electrode.
16062615|NCT02435927|Drug|ASLAN001+ CAPOX (Oxaliplatin, capecitabine)|ASLAN001 in combination with oxaliplatin and capecitabine
16062616|NCT02435927|Drug|ASLAN001 + mFolfox6 (5-FU, leucovorin)|ASLAN001 in combination with 5-FU and leucovorin
16062617|NCT02435914|Drug|AGN-223575 ophthalmic solution|AGN-223575 ophthalmic solution once or twice daily
16062618|NCT02435914|Drug|AGN-223575 vehicle ophthalmic solution|Vehicle to AGN22375 ophthalmic solution once or twice daily.
16062619|NCT02435901|Drug|alemtuzumab (Campath IH)|Alemtuzumab (Campath IH) is given daily over first 4 days, Day -20 to Day -17
16062620|NCT02435901|Drug|Fludarabine|Fludarabine 35/m2 is given daily over 4 days on Day -7 to Day -4.
16062621|NCT02435901|Drug|Melphalan|Melphalan 70mg/m2 is given daily over 2 days on Day -3 to Day -2.
16062622|NCT02435901|Drug|Cyclosporine|Immunosuppressant to prevent graft vs host disease is given on Day -1 prior to stem cell infusion
16062623|NCT02435901|Drug|Mycophenolate mofetil|Immunosuppressant to prevent graft vs host disease is given on Day -1.
16062624|NCT02435901|Drug|Tacrolimus|Immunosuppressant to prevent graft vs host disease is given Day -1 prior to stem cell infusion
16062625|NCT02435901|Biological|Hematopoietic Stem Cell Transplantation|Human Leukocyte Antigen (HLA) matched or mismatched; related or unrelated hematopoietic stem cells to be transplanted on Day 0.
16062626|NCT02435875|Other|no intervention|Antihypertensive drug as intervention is used to see if it can improve baroreflex sensitivity to stable perioperative hemodynamic
16062627|NCT02435862|Drug|1.0mg Luminate®|
16062628|NCT02435862|Drug|2.0mg Luminate®|
16062629|NCT02435862|Drug|3.0mg Luminate®|
16062630|NCT02435862|Other|Balanced Salt Solution for intravitreal injection in 0.10cc|
16062631|NCT02435849|Biological|Single dose of CTL019|2 to 5 x 10(6) autologous CTL019 transduced cells per kg body weight, with a maximum dose of 2.5 x 10(8) autologous CTL019 transduced cells via intravenous infusion.
16062632|NCT02435836|Drug|Aripiprazole|
16062633|NCT02435823|Device|PulseRider|Adjunctive device for endovascular embolization of intracranial aneurysms
16062634|NCT02435797|Drug|Nicorandil|All patients received antiplatelet agents (aspirin, ticagrelor) and heparin.Diagnostic coronary angiography (CAG) was performed via the right (or left) femoral artery or radial artery using the Seldinger method.The guidewire was passed into the culprit lesion. Subjects in the NicorandilGroup were then given 2 mg intracoronary nicorandil through the lesions via thrombus aspiration catheter, and an additional intracoronary dose of 2 mg nicorandil before stent implantation. A minimum 5-min interval occurred between the first and second doses of nicorandil to reduce adverse effects.
16062635|NCT02435797|Drug|normal saline|All patients received antiplatelet agents (aspirin, ticagrelor) and heparin.Diagnostic coronary angiography (CAG) was performed via the right (or left) femoral artery or radial artery using the Seldinger method.The guidewire was passed into the culprit lesion. Normal saline in the Placebo Group were then given 2 ml through the lesions via thrombus aspiration catheter,and an additional intracoronary dose of 2 ml before stent implantation. A minimum 5-min interval occurred between the first and second injection.
16062636|NCT02435784|Other|The Two-Way Communication Checklist|The Two-Way Communication Checklist (2-COM) is a communication tool developed by Van Os et al. (2002). It aims to provide an opportunity for patients to voice their needs and problem to minimize the discrepancy and miscommunication between patient and professional carer. 2-COM questionnaire was designed to give patients while they are waiting for consultation. Patients can either tick yes or no in the questionnaire to decide which the perceived problems are and which needs they want to discuss with the clinician. During the consultation, the ticked items would be discussed.
16062637|NCT02435784|Other|Treatment as usual|Patients will attend a psychiatric consultation as usual.
16062638|NCT02435771|Drug|Ergocalciferols|Treatment 1- 400,000 IU
16062639|NCT02435771|Drug|Ergocalciferols|Treatment 2- 800,000 IU
16062640|NCT02435758|Procedure|Preservation of Denonvilliers Fascia during L-PANP surgery|In this group, the patients accept L-PANP surgery, as well as preservation of Denonvilliers Fascia
16062641|NCT02435732|Drug|Placebo saline solution|saline solution
16062644|NCT02435706|Procedure|Flapless immediate implant placement|Experimental group: No elevation of flap prior to immediate implant placement
16062645|NCT02435706|Procedure|Flap assisted immediate implant placement|Control group: Flap will be elevated prior to immediate implant placement
16062646|NCT02435706|Device|Implant and temporary crown|Both groups receive this intervention
16062647|NCT02435693|Other|PHARMACEUTICAL CARE programe|The pharmaceutical care program was characterized by face to face monthly visits to collect information, register information, prepare plan of care for every health problem; identification of drug therapy problems, communication to prescribers the drug therapy problems identified and education of participants to resolve the drug therapy problems.
16062648|NCT02435693|Other|Without PHARMACEUTICAL CARE programe|
16062649|NCT02435680|Drug|MCS110|taken by I.V
16062650|NCT02435680|Drug|carboplatin|taken by I.V
16062651|NCT02435680|Drug|gemcitabine|taken by I.V
16062652|NCT02435667|Other|Resistance Exercise Training|"Aerobic Exercise
~a. Each participant will engage in 5 minutes of aerobic based exercise on an arm/leg ergometer (NuStep Cross Trainer) at an intensity of 12-14 on the Borg Rating of Perceived Exertion Scale as a warm-up prior to the exercise session and again as a cool-down at the end of the exercise session.
~Resistance Exercise - 2 sets of 8-12 repetitions - beginning at 60% of the initial 1 RM.
~a) Leg Extension, b) Bicep Curl, c) Leg Press, d) Chest Press, e) Leg Curl, f)Seated Row (horizontal or pulldown), g) Calf Raises
~Core Strengthening Exercises a. 5-10 minutes of stability ball and balance exercises"
16062653|NCT02435667|Radiation|DEXA bone scan|A DEXA scan that provides bone density measures.
16062654|NCT02435667|Other|Cardiopulmonary Max Exercise Test|Pedaling on a cycle ergometer to volitional fatigue.
16062655|NCT02435667|Other|Quality of Life Questionnaire|A 10 minute questionnaire that measures quality of life.
16062656|NCT02435667|Other|Submaximal Exercise Test|Two short submaximal constant-load exercise sessions at 20 Watts. Each session will include 6 minutes of cycling (baseline). Following baseline, the sessions will be randomized to continued constant-load cycling for an additional 9 minutes (for echocardiographic measures) or randomized sub-systolic inflation of bilateral thigh pressure tourniquets to 40 and 80 mmHg for 3 minutes with 3 minutes of deflation between inflations to stimulate locomotor muscle neural feedback.
16062657|NCT02435667|Other|Blood Draw|A blood draw amounting to 1 teaspoon of blood drawn.
16062658|NCT02435654|Drug|olanzapine|olanzapine will be initiated at 2.5 or 5 mg/day according to patient's weight, and the dose could be increased by 2.5 or 5 mg every 4-7days at the investigator's discretion.A effective dose would be titrated in two weeks with no tolerability or safety issues are apparent,
16062659|NCT02435641|Other|Questionnaires|All subjects (patients and caregivers) will complete a battery of psychological questionnaires at baseline (ICU admission), 3 months post-baseline, and 6 months post-baseline.
16062660|NCT02435628|Other|Questionnaires|All subjects will complete baseline psychological assessments prior to their medical visit. Upon completion of their routine medical visit, subjects will complete a post-test assessment measuring their satisfaction with the visit.
16062661|NCT02435615|Device|SaniSal Oral Fluid Collector|SaniSal is an oral fluid collector used to collect oral fluid from the mouth with an absorbant sponge.
16062662|NCT02435602|Procedure|NBI endoscopy|GI endoscopy examination and additional the entire length of esophagus is evaluate with NBI endoscopy Biopsy at the visually abnormal lesions
16062663|NCT02435602|Procedure|Lugol chromoendoscopy|GI endoscopy examination and additional the entire length of esophagus is evaluate with Lugol chromoendoscopy Biopsy at the unstained lesions >= 5 mm diameter Pathologic examination of all biopsy tissue specimens
16062664|NCT02435589|Other|Systematic pain assessment|Systematic assessment of pain twice daily with the use of 2 different behavioral pain tools (Behavioral Pain Scale - BPS, and Critical Care Pain Observation Tool - C-POT) for non-communicative patients and Numerical Rating Scale (NRS) 1-10 for communicative patients.
16062665|NCT02435589|Other|Notification of results of assessments|Pain assessments will be carried out by independent investigators who will notify the results to ICU nurses and physicians and observe and document their reaction
16062666|NCT02435576|Radiation|Radiotherapy (primary or postoperative)|
16062667|NCT02435563|Drug|ticagrelor 180 mg administrated alone|
16062668|NCT02435563|Drug|Ticagrelor adjusted dose + ritonavir 100mg|
16062669|NCT02435550|Genetic|Molecular diagnostic testing|Molecular diagnostic testing will be performed on peripheral blood, bone marrow aspirate and saliva samples that will be collected from each patient as part of routine care. Tests performed may include: cytogenetics, FISH, chromosome copy number variation, next generation DNA sequencing, methylation, and metabolomics.
16062670|NCT02435537|Drug|Dexmedetomidine (Precedex)|intrathecal administration
16062671|NCT02435537|Drug|Bupivacaine|intrathecal 10 mg bupivacaine
16062672|NCT02435537|Drug|Morphine|intrathecal 0.5mg morphine
16062673|NCT02435524|Behavioral|A&T infant and young child feeding intervention|"Interpersonal communication delivered by community workers and volunteers during home visits and at monthly mother's group meetings to:
~Increase mother's knowledge about optimal breastfeeding and its benefits
~Increase mother's self-efficacy related to breastfeeding
~Improve mother's perceptions about social norms relating to breastfeeding
~Community mobilisation activities to:
~- Raise awareness of the benefits of optimal breastfeeding among opinion leaders, and family members, and increase the support they provide to breastfeeding mothers
~Enhanced training of government health workers in infant and young child feeding to:
~Improve their ability to support mothers and provide timely information about infant feeding"
16062674|NCT02435511|Other|HealtheRx|The HealtheRx is an informational intervention. The HealtheRx is generated and administered at the point of care. It includes a list of community resources, tailored to a patient's needs based on diagnoses, that are located near the patient's home. A health care provider and/or administrative staff administers and reviews the HealtheRx with the patient.
16062675|NCT02435498|Other|Interactive website|The interactive website called Online User Centered Home Pain Management for Fractures (OUCH PMF) will cover 4 domains of knowledge: 1. Fracture-related pain 2. Analgesic dosing regimens 3. Indications, risks and safety of analgesia in children 4. Signs and symptoms of pain in children
16062676|NCT02435498|Other|Video|The online video will contain the same information within the website.
16062677|NCT02435498|Other|Standard of care|Standard of care includes a pamphlet with cast care instructions and verbal instructions on caring for the child at home.
16062678|NCT02435485|Device|Biodex balance training|1.weight shift training, 2. random control training with Biodex balance system.
16062679|NCT02435485|Other|Rehabilitation including core spinal stabilization exercise|Rehabilitation: 2-3 times a week, up to 8 weeks, 15 sessions in total. Each session will include hot packing, interferential therapy, core spine stablilzation exercise and low extremity strengthening exercise.
16062680|NCT02435472|Behavioral|Exercise|This open-label, two-arm randomized controlled trial (RCT) will investigate the effects of 16 weeks of structured aerobic training, relative to usual care (print material with physical activity guidance) in 76 men with histologically confirmed low-risk prostate adenocarcinoma on active surveillance. The only investigational therapeutic agent being tested in this trial is a behavioral intervention in the form of aerobic training.
16062681|NCT02435472|Other|Cardiopulmonary Exercise Test (CPET)|Exercise capacity test to assess peak oxygen consumption (VO2peak)
16062682|NCT02435459|Procedure|No lining|No lining material placed under amalgam dental restorations
16062683|NCT02435459|Procedure|Calcium Hydroxide cement|placement of lining material under amalgam dental restorations
16062684|NCT02435459|Procedure|RMGI cement|placement of lining material under amalgam dental restorations
16062685|NCT02435459|Procedure|Resin Bonding Agent|placement of lining material under amalgam dental restorations
16062686|NCT02435446|Device|Cone-beam computed tomography|Cone-beam computed tomography
16062687|NCT02435433|Drug|Ramucirumab|Administered IV
16062688|NCT02435433|Drug|Placebo|Administered IV
16062689|NCT02435420|Device|EMPERION Modular Primary Stem|Primary total hip arthroplasty using the EMPERION Modular Primary Stem
16062690|NCT02435407|Behavioral|SOS|Ten (10) children will be randomized to participate in the SOS intervention arm. The intervention will be divided into two groups of 5 children with 2 therapists assigned. The children will attend 1 hour intervention sessions once a week for 12 weeks. Here they will be introduced to different types of foods that they would not have typically eaten in a play based group session. The SOS intervention utilizes the principle of hierarchal desensitization.
16062691|NCT02435407|Other|Education|Parents will be given three 1 hour educational talks around the aetiology and management of feeding difficulties in children with autism spectrum disorder. This will be administered at 3 distinct time points; baseline, week 6 and week 12 of the study.
16062692|NCT02435394|Behavioral|Remote Coach plus Asthma Module|The intervention is for a remote coach to assist patients with asthma for practices which will use Asthma module for guidance for asthma care.
16062693|NCT02435394|Behavioral|Asthma Module- No Coach|The intervention is for practices to use the Asthma module for guidance for asthma care without assistance by a remote coach.
16062694|NCT02435394|Behavioral|CHADIS- no Asthma Module|The practices will use the general CHADIS tool without access to the Asthma Module add-on to assist in asthma care.
16062695|NCT02435381|Drug|Carisbamate|600mg Orally on days 2-4
16062696|NCT02435381|Drug|Placebo|Placebo treatment only
16062697|NCT02435368|Drug|mycophenolic acid|Monocytes were co-cultured with LPS and/or MPA.After 12 hours, the supernatants were harvested and stored at -80°C for ELISA.
16062698|NCT02435355|Behavioral|telephone-based counselling|The objective of the first session was to assess the patient's knowledge about the disease, device and health consequences. The importance of good adherence was emphasized, encouraging the patients to use the CPAP device throughout sleep every day. Objectives of the other educational sessions were first to identify disadvantages or obstacles to follow CPAP treatment and then focus on the benefits linked to use of CPAP. A particular effort was made to discuss misconceptions about sleep apnea and barriers to use, concerns fears and beliefs, as well as the perceptions of their partners and family, in order to increase patients' positive expectations regarding CPAP benefits.
16062699|NCT02435342|Drug|dalazatide|Subcutaneous injection twice per week for a total of 9 doses, followed by four weeks of follow-up.
16062700|NCT02435342|Drug|placebo|placebo, Subcutaneous injection twice per week for a total of 9 doses
16062701|NCT02435329|Other|Baseline comparison of microcirculation and bone metabolism|Baseline comparison of microcirculation and bone metabolism among the 5 different groups
16062702|NCT02435316|Other|Case vignette-based teaching of cell recognition|Intervention group members will be taught peripheral blood smears by using power point slides and utilizing additive microskills using the compare/ contrast technique to recognize various cell types. Memory will be reinforced by using cases to help recognize the clinical importance of learning about individual cell types.
16062703|NCT02435316|Other|Compare-contrast basic science teaching of cell recognition|The control group will be given a traditional 60-minute lecture using board review questions with accompanying pictures of peripheral blood smears, without explaining individual cell type.
16062704|NCT02435303|Drug|Sildenafil|
16062705|NCT02435303|Drug|Placebo|
16062706|NCT02435290|Behavioral|determine the incidence , type , and severity of prescribing errors in the oncology department|"patients' files are revised according to BCCA reference protocols to report errors which are categorized according to type,and severity including: BSA calculation, the eligibility of the chemotherapy protocol , the dosage form ,dosage , the modification of doses according to toxicity and laboratory data results ,frequency ,duration of treatment , intention of treatment , the omitted or duplicated medications ,and the drug interactions.
~the impact of the risk factors on the incidence , and type of prescribing errors are studied including :The tumor type, Cancer stage , co morbid illness,The number of drugs in the treatment regimen ,The route of administration of chemotherapy ,Dosing Frequency of treatment, The toxicity of chemotherapy experienced by the patient, The number of abnormal lab data,The type of abnormal lab data ,the age of patient.
~."
16062707|NCT02435277|Drug|Low Metformin|1100 mg L Leucine in combination with 125 mg of Metformin BID
16062708|NCT02435277|Drug|Mid Metformin|1100 mg L Leucine in combination with 250mg Metformin BID
16062709|NCT02435277|Drug|High Metformin|1100 mg of L Leucine in combination with 500 mg Metformin BID
16062710|NCT02435277|Drug|Metformin|500 mg Metformin BID until day 14 with dose escalation at day 14 to 850 mg Metformin BID
16062711|NCT02435264|Other|Healthier Dining Program Intervention|The food environment at the intervention centers will be modified to increase the availability of healthier foods and low calorie meals.
16062712|NCT02435251|Device|dual energy X-ray absorptiometry|
16062713|NCT02435225|Behavioral|Mindfulness Based Stress Reduction for Teens Group|A 12-Week weekly group intervention to train adolescents in mindfulness practice
16062716|NCT02435199|Drug|EMA401 600mg|
16062717|NCT02435199|Drug|Placebo|
16062718|NCT02435186|Drug|p53 gene|p53 gene will be given intraperitoneally.
16062719|NCT02435186|Drug|Cisplatin|150 mg/m^2 cisplatin will be given intraperitoneally.
16062720|NCT02435186|Drug|Paclitaxel|Paclitaxel (175 mg/m2, 3 h) will be given by iv
16062721|NCT02435173|Drug|CDZ173|Part I: 10, 30 and 70 mg bid Part II: 70 mg bid
16062722|NCT02435173|Other|Placebo|Placebo 70 mg bid
16062723|NCT02435160|Biological|Fecal Microbiota Transplantation|
16062724|NCT02435147|Drug|denosumab|Patients will receive denosumab 60 mg subcutaneously every six months as part of their standard osteoporosis treatment.
16062725|NCT02435134|Other|no intervention|
16062726|NCT02435121|Drug|SAR125844|Pharmaceutical form:Concentrate for solution Route of administration: intravenous
16062727|NCT02435108|Drug|crizotinib|crizotinib 250mg bid daily
16062728|NCT02435095|Drug|Maintenance treatment|"Treatment with antipsychotic drug (either second-generation antipsychotics or low-dose first generation antipsychotics) for at least 12 months.
~All antipsychotics approved in Germany are permitted (amisulpride, aripiprazole, benperidol, bromperidol, chlorprothixene, clozapine, flupentixole, fluphenazine, fluspirilene, haloperidol, levomepromazine, loxapine, lurasidone, melperone, olanzapine, paliperidone, perazine, perphenazine, pimozide, pipamperone, prothipendyl, quetiapine, risperidone, sertindole, sulpiride, thioridazine, ziprasidone, zuclopenthixole)."
16062729|NCT02435095|Drug|Intermittent treatment|"Treatment with antipsychotic drug (either second-generation antipsychotics or low-dose first generation antipsychotics) only for first episode of schizophrenia, tapering-off medication after remission of positive symptoms, reinstatement of treatment only in case of recurrence of positive symptoms.
~All antipsychotics approved in Germany are permitted (amisulpride, aripiprazole, benperidol, bromperidol, chlorprothixene, clozapine, flupentixole, fluphenazine, fluspirilene, haloperidol, levomepromazine, loxapine, lurasidone, melperone, olanzapine, paliperidone, perazine, perphenazine, pimozide, pipamperone, prothipendyl, quetiapine, risperidone, sertindole, sulpiride, thioridazine, ziprasidone, zuclopenthixole)."
16062730|NCT02435069|Drug|Dose Response - NS and USP Glycerin - First Intervention|This trial used a repeated measures, single subjects alternating treatments A-B-C-B'-C'-B1' withdrawal design in which all subjects were tested under all conditions and each subject acted as his or her own control. The subjects were randomly assigned to either normal saline or USP glycerin to control for order effects. Baseline data A served as the control and was obtained pre-operatively. The B-C arm evaluated dose-response relationship and was used to identify the minimum dosing volume and frequency of ACE administration of NS and USP Glycerin necessary to promote fecal continence. When the optimal dose as identified, the child continued on that dose for 2 weeks to insure treatment stability and effectiveness.
16062731|NCT02435069|Drug|Effectiveness - NS and USP Glycerin - Second Intervention|To prevent statistical bias from subject loss due to treatment failure, each child was randomized to a second treatment sequence once they have achieved continence with minimal side effects on optimal dosing The second phase B'-C'-B1' of the study compared the two regimens at optimal dose and administration frequency. This phase was used to confirm the effectiveness of NS and USP Glycerin at optimal dosing on continence and assess side effects.
16062732|NCT02435056|Other|IEPR Approach|"Adoption of Interactive Electronic Patient Record (IEPR) that consists of the following clinically-relevant main components:
~Minimum Data Set for supporting the diagnosis
~Electronic Diary with associated alerting system for monitoring the patient during the follow-up period
~Second opinion system for improving the management"
16062733|NCT02435043|Other|Nature based rehabilitation|ten weeks of nature-based rehabilitation, as add-on to standard management. A rehabilitation program in groups up to 8 patients in an especially designed garden at the Swedish University of Agricultural Sciences, Alnarp. The intervention was grounded in environmental psychology and occupational therapy, supported by a multimodal rehabilitation team that utilized the garden/nature for sensory stimulation, body awareness, meaningful occupations and nature experiences.
16062734|NCT02435043|Other|standard management after stroke|standard management after stroke is individualised.
16062735|NCT02435004|Device|Spinal Modulation Axium™|"The participants will undergo implantation of electrodes for stimulation of fuor dorsal ganglia (Spinal Modulation, Inc., Menlo Park, CA, USA). Each participant will have one to four electrodes positioned according to the individual distribution of pain in the extremities. After implantation the electrode will be connected to an external neurostimulator: Spinal Modulation Axium™ for 3-30 days to evaluate their effectiveness (test stimulation).
~If during the trial treatment the pain will decrease significantly (> 50%) a neurostimulator will be 'implanted for the continuation of the permanent neurostimulation. The neurostimulator is implanted in the abdomen in a subcutaneous pocket."
16062736|NCT02434991|Device|Barostat|"During this study, the investigators will ask you to fill out questionnaires about your swallowing, chest pain, and heartburn. The investigators hope the patient will answer all of the questions, but patients can skip any questions they do not want to answer. The questionnaires will take about 15 minutes to complete.
~A urine pregnancy test for females of childbearing years.
~Patients will be asked to fast overnight (nothing to eat or drink for 8 hours) prior to the barostat test.
~At this point healthy controls have completed the study.
~Patients with achalasia will then undergo treatment for achalasia at the discretion of the primary clinician managing their case.
~Patients will be contacted to complete a phone survey 3 & 6 months and 2 & 4 years after treatment."
16062737|NCT02434978|Device|Supplementary endoscopy with doppler-guided therapy|Patients randomized to supplementary doppler-guided therapy undergo repeat endoscopy with doppler evaluation within 24 hours from the primary endoscopy. At the control endoscopy the ulcer base is examined using a doppler device. If active doppler flow is demonstrated the ulcer is treated with a thermal probe until a control doppler-scan is negative. All patients are observed for rebleeding at a specialized GI-bleeding unit.
16062738|NCT02434978|Drug|IV. PPI|All patients receive 80mg of Esomeprazole iv as a bolus followed by 8mg Esomeprazole per hour for 72 hours.
16062739|NCT02434978|Other|Endoscopic treatment at primary endoscopy|All patients are initially treated with endoscopic therapy using a minimum of two different treatment modalities. The primary endoscopy is performed wihtin 24 hours from time of admission to hospital
16062740|NCT02434965|Drug|HPDSC|Autologous HPDSC collected after birth will be infused in aliquots. one-half of the HPDSC infused on Day 2; one-half of the collected HPDSC will be infused on Day 8.
16062741|NCT02434965|Drug|Cord blood|Autologous Cord Blood collected after birth will be infused in aliquots. One-third of the collected cord blood will be infused within the first 24 hours after birth (Day 0); one-third of the collected cord blood will be infused on day 3; and one-third of the collected cord blood unit will be infused on Day 7.
16062742|NCT02434952|Drug|Dihydroartemisinin piperaquine (DHA PP)|
16062743|NCT02434952|Drug|Primaquine|
16062744|NCT02434939|Drug|Low dose ketamine|Children in this arm shall receive a slow infusion of ketamine at a sub-anesthetic dose and monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min.
16062745|NCT02434939|Drug|Morphine|Children in this arm shall receive intravenous infusion of morphine at analgesic dose and then monitored for pain, vital signs and side effects for 2 hours. Records will be taken at 5, 10, 20, 40, 60, 80, 100 and 120min.
16062746|NCT02434913|Device|SR PIP Implant System|HUD for use in arthroplasty of the PIP joint
16062747|NCT02434887|Device|KL029 Intimate Lubricant Gel|
16062748|NCT02434874|Device|StimGuard Sacral Nerve Stimulator System|The StimGuard Sacral Nerve Stimulator System is a wirelessly powered neurostimulator for urge urinary incontinence. This technology includes a quadripolar stimulator with an embedded receiver. The energy source is a small, external, rechargeable transmitter, which is worn by the patient. The transmitter sends the therapy program and power through the skin and to the receiver.
16062749|NCT02434861|Drug|Rolapitant|
16062750|NCT02434861|Drug|Digoxin|P-gp substrate
16062751|NCT02434861|Drug|Sulfasalazine|BCRP substrate
16062752|NCT02434861|Drug|Cooperstown Cocktail|Midazolam, omeprazole, warfarin, caffeine, and dextromethorphan
16062753|NCT02434848|Drug|Engerix B|"Engerix B 20 micrograms/1ml Licensee: GlaxoSmithKline UK Intra-muscular
~Prescription and administration:
~The vaccine will be stored in the Investigators pharmacy as clinical trial stock and dispensed on a subject by subject basis.
~Shelf life and storage The product must be kept refrigerated (2°C - 8°C). Prescriptions will be written and dispensed from pharmacy on the day of consent, screening and vaccination. The shelf life is 3 years."
16062754|NCT02434848|Drug|Fendrix|"Fendrix suspension for injection GlaxoSmithKline UK
~Route of Administration, dose regimen:
~Intra-muscular Dose: 0.5ml (20mcg of Hepatitis B Surface Antigen) per vaccination at baseline and weeks 4, 8 and 24.
~Prescription and administration:
~The vaccine will be stored in the Investigators pharmacy as clinical trial stock and dispensed on a subject by subject basis.
~Packaging and labeling The vaccine will have clinical trial labeling. Shelf-life and storage The product must be kept refrigerated (2°C - 8°C).
~The shelf life is 3 years."
16062755|NCT02434835|Drug|[14C]KWA-0711|
16062756|NCT02434822|Biological|Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell|1.5 mL, Oral administration
16062757|NCT02434822|Biological|Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell|1.5 mL, Oral administration
16062758|NCT02434822|Biological|Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell|1.5 mL, Oral administration
16062759|NCT02434809|Procedure|Bronchoscopic Implantation|Calypso transponders
16062760|NCT02434809|Device|Cone-Beam CT-Guided|
16062761|NCT02434809|Radiation|stereotactic body radiation treatments|
16062762|NCT02434796|Behavioral|Male Peer Groups|In Intervention Arm 1, male partners participate in male peer group workshops on gender norms, IPV and HIV prevention. Men's peer groups address gender inequality and transformation of gender power relations, positive masculinities and accountability of men in the perpetration of violence against women. This intervention aims to improve knowledge and attitudes among men about the harms of IPV on women, men and children; the confidence to internalize positive masculine ideals and to challenge gender stereotypes; and the ability to formulate positive outcome expectations regarding IPV and healthy relationships with their spouses and communities. Male peer group workshops will be conducted as a series of four workshops for a total of 24 hours spread out over a 5-month period.
16062763|NCT02434796|Behavioral|Male Peer Groups and Community Dialogues|Men participate in male peer group workshops as in Intervention Arm 1. In addition, village level community leaders engage in community mobilization/sensitization activities that include women members of savings groups and their male partners who participate male peer groups. Community dialogues focus on gender norms, IPV and HIV prevention. First, a one-day workshop for community leaders on topics similar to those raised in male peer group sessions. Second, trained community leaders facilitate community dialogues on IPV, HIV prevention, and gender norms with savings groups members and their male partners who participate in male peer groups. Each workshop will be a day-long event.
16062764|NCT02434770|Biological|BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 1|Each dose of bOPV (2 drops, 0.1 ml) contains attenuated Sabin strains of poliovirus serotypes 1 and 3, with at least 10^6 cell culture infectious dose 50% (CCID50)/dose and 10^5.8 CCID50/dose, respectively.
16062765|NCT02434770|Biological|BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 2|Each dose of bOPV (2 drops, 0.1 ml) contains types 1 and 3 attenuated polioviruses (Sabin), with at least 10^6 CCID50/dose and 10^5.8 CCID50/dose, respectively.
16062766|NCT02434770|Biological|BioFarma Bivalent Oral Poliomyelitis Vaccine|Each dose of the WHO prequalified Bio Farma bOPV (2 drops, 0.1 ml) contains attenuated Sabin strains of poliovirus serotypes 1 and 3, with at least 10^6 and 10^5.8 infective units per dose, respectively.
16062767|NCT02434757|Drug|H.P. Acthar Gel|Acthar 40 U given SC daily for 7 days. Depending on the response and the Investigator,Acthar 40 U will continue Acthar 40 U 2x per week or increase to Acthar 80 U daily for 7 days followed by 2x per week
16062768|NCT02434744|Drug|KD026|Dosed in combination
16062769|NCT02434744|Drug|Placebo|Dosed in combination
16062770|NCT02434744|Drug|Metformin|Drug prescribed by each subject's prescribing physician
16062771|NCT02434731|Device|Buzzy® device|Buzzy® is a battery-powered device for venipuncture pain relief combining cold, vibration, and distraction.
16062772|NCT02434718|Drug|Aducanumab|As described in the treatment arm
16062773|NCT02434718|Drug|Placebo|IV administration of 0.9% sodium chloride
16062805|NCT02434354|Drug|pembrolizumab|200 mg Subjects will receive 1 dose of neoadjuvant pembrolizumab, followed by complete resection and then a year of adjuvant pembrolizumab
16063061|NCT02432365|Drug|paclitaxel|7-day cycle schedule of paclitaxel (60 mg/m2)
16062774|NCT02434705|Other|Antigen (wheat base soy sauce) spray|Patients having a clinically indicated endoscopy for Eosinphilic Esophagitis will have two biopsies from the esophageal body, 10 cm above the gastroesophageal junction. After biopsies are taken, approximately 10 cc of wheat based soy sauce will be sprayed though an endoscopic catheter onto the esophageal mucosa. The endoscopic examination will be completed and Two additional endoscopic biopsies will be taken 10 cm above the gastroesophageal junction.
16062775|NCT02434692|Device|ARGOS-IO system|Implantation of ARGOS-IO pressure sensor after cataract surgery on day 0 (V01)
16062776|NCT02434666|Drug|CPC-201|
16062777|NCT02434653|Other|Monitoring hemoglobin levels following anemia associated symptoms|Post-partum anemia will be diagnosed after vaginal delivery by taking hemoglobin levels to patients with symptoms consistent with anemia, severe postpartum hemorrhage or hemoglobin level below 8 g/dL.
16062778|NCT02434653|Other|Monitoring hemoglobin levels to detect anemia by screening of women at increased risk for post partum anemia|Post-partum anemia will be diagnosed after vaginal delivery by taking hemoglobin levels to high risk women for post-partum anemia, defined as hemoglobin levels of 10.5 g/dl or below around delivery, or severe postpartum hemorrhage with or without symptoms associated with anemia
16062779|NCT02434640|Drug|BAY1128688|Part A: Single dose and multiple dose for 14 days (postmenopausal women)
16062780|NCT02434640|Drug|Placebo|Part A: Single dose and multiple dose for 14 days (postmenopausal women)
16062781|NCT02434640|Drug|BAY1128688|Part B: Multiple dose for 28 days (premenopausal women)
16062782|NCT02434627|Drug|Sodium Nitrate|Patients will be given sodium nitrate daily in the form of beetroot juice.
16062783|NCT02434614|Drug|Docetaxel,Cisplatin,Fluorouracil|Induction chemotherapy: patients receive 60 mg/m2 docetaxel intravenously on day 1, 60 mg/m2 cisplatin intravenously on day 1, and 600 mg/m2/d fluorouracil as a continuous infusion on days 1-5; three cycles were administered at intervals of 3 weeks.
16062784|NCT02434614|Radiation|Intensity-modulated radiation therapy (IMRT)|IMRT is given as 2.0-2.3 Gy per fraction with five daily fractions per week for 6-7 weeks, Cumulative doses were > 66 Gy to the primary tumor and > 50 Gy to the bilateral cervical lymph nodes and potential sites of local infiltration.
16062785|NCT02434614|Drug|Cisplatin|Concurrent chemotherapy: patients received weekly intravenous cisplatin at 30 mg/m2 for 6-7 weeks.
16062786|NCT02434601|Procedure|Treatment of Dentin Surface|"Experimental Group 1: Increase the etching time to 30 seconds, performed with phosphoric acid gel at 37%, prior to application of the resin adhesive.
~Experimental Group 2: Prophylaxis cavity probe / blunt tip of ultrasound, applied for 30 seconds on the dentin surface hypermineralized of cervical lesions non-carious.
~Both restorative procedures were performed using a conventional adhesive system and composite restorative nanoparticulate."
16062787|NCT02434601|Procedure|Dentin Surface|Treatment of Dentin Surface: Increased etching dentin for 15 seconds to 30 seconds
16062788|NCT02434601|Procedure|Treatment|Treatment of Dentin Surface: Intervention with the cavity prophylaxis probe ultrasound blunt applied for 30 seconds in Surface hypermineralized non-carious dentin cervical lesions. Therefore, the restoration was done following the protocol recommended by the manufacturer of the material.
16062789|NCT02434588|Device|Bhattacharjee ring|Insertion of a Bhattacharjee ring to stabilise the pupil during cataract surgery
16062790|NCT02434562|Other|Serum (with or without urine) samples|
16062791|NCT02434549|Drug|Dysport®|Intramuscular injections in spastic muscle with regional muscle-related pain
16062792|NCT02434549|Drug|Normal saline|Intramuscular injections in spastic muscle with regional muscle-related pain
16062793|NCT02434523|Drug|Amitriptyline|Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
16062794|NCT02434523|Other|Placebo|Subjects in this arm will receive pills composed of only Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks
16062795|NCT02434497|Drug|Rosuvastatin 20mg|Active drug 1 or 2 tablets will be taken taken orally, QD, either in the morning or in the evening
16062796|NCT02434471|Device|Respiratory-triggered T1w DISCO LAVA|"The study will acquire extra image sets using DISCO LAVA with one breath hold during the arterial imaging phase. No additional breath holds will be required.
~Respiratory-triggered T1w DISCO LAVA precontrast
~Respiratory-triggered T1w DISCO LAVA in the portal venous phase
~Respiratory-triggered T1w DISCO LAVA in the equilibrium phase"
16062797|NCT02434432|Behavioral|music therapy selected by mothers|mothers' choice of music
16062798|NCT02434432|Behavioral|Music therapy recorded lullaby|recorded lullaby
16062799|NCT02434419|Device|PENS|The participants underwent one 30-min session every week for 12 consecutive weeks. PENS was delivered by a needle electrode inserted in the medioclavicular line, 2 cm below the clavicle at a 90° angle towards the skin at a depth of approximately 1 cm. PENS was undertaken at frequency of 20 Hz at the highest amplify (0-20 mA) without causing pain. PENS was delivered simultaneously in both pectoral muscles.
16062800|NCT02434419|Other|Specific training|Patients underwent specific training exercises to improve pectoral fitness.
16062801|NCT02434406|Behavioral|internet-What Am I Worried About|This web-based intervention consists of three sections: 1) Is this for me? 2) Practice 3) Understanding. The three main sections are divided up into nine sessions. Participants will get access to the program for eight weeks and can access the sessions more than once. Sessions are made up of multimedia presentations and worksheets that are completed online.
16062802|NCT02434380|Dietary Supplement|Euro D|Vitamin D3 Euro D 10,000 IU (1 tablet) plus Euro D Placebo (1 tablet) weekly, alternating with Euro D Placebo (2 tablets) weekly, starting at the second trimester and continued until delivery.
16062803|NCT02434380|Dietary Supplement|Euro D|Vitamin D3 Euro D 10,000 IU (2 tablets, equivalent to 20,000 IU) weekly, starting at the second trimester and continued until delivery.
16062804|NCT02434367|Behavioral|Walk With Ease Arm A|Walk With Ease is the Arthritis Foundation's evidence-based walking intervention to help with fatigue and pain. The interention is a self directed program that helps guide participants in a safe and comfortable paced walking program with an ultimate goal of walking for 30 minutes per day, five days per week.
16062852|NCT02433886|Procedure|Gamma Ventral Capsulotomy|
16062806|NCT02434328|Drug|Brolucizumab ophthalmic solution|Ophthalmic solution for IVT injection administered as a 6 mg/50 µL dose
16062807|NCT02434328|Drug|Aflibercept ophthalmic solution|Ophthalmic solution for IVT injection administered as a 2 mg/50 µL dose
16062808|NCT02434315|Device|FreeStyle Libre Pro 4 sensor wears, 2 with reviews|Subjects will wear the FreeStyle Libre Pro System for 14 days. 2 period of FreeStyle Libre Pro Sensor wear for data review followed by 2 further periods of Sensor wear for time in range measurement with 28 day interval between wears.
16062809|NCT02434315|Device|FreeStyle Libre Pro 6 sensor wears, 4 with reviews|Subjects will wear the FreeStyle Libre Pro System for 14 days. 4 period of FreeStyle Libre Pro Sensor wear for data review followed by 2 further periods of Sensor wear for time in range measurement with 28 day interval between wears.
16062810|NCT02434315|Device|FreeStyle Libre Pro 3 sensor wears|Subjects will wear the FreeStyle Libre Pro System for 14 days. 3 periods of Sensor wear for time in range measurement over a period of approximately 8 months.
16062811|NCT02434289|Dietary Supplement|Dietary protein products|Increased protein intake via dairy products, guided by a dietician.
16062812|NCT02434289|Other|Resistance exercise training|Resistance exercise training in small groups for twelve weeks, two times a week, guided by physiotherapists.
16062813|NCT02434276|Biological|VAX2012Q|Recombinant influenza hemagglutinin (HA) vaccine consisting of two influenza A subtypes and two influenza B lineages
16062814|NCT02434276|Biological|Fluzone Quadrivalent|Fluzone Quadrivalent (Influenza Vaccine)
16062816|NCT02434250|Procedure|Selective Laser Trabeculoplasty|Selective Laser Trabeculoplasty is a laser treatment procedure to enhance trabecular aequous humor outflow and thus decrease intraocular pressure.
16062817|NCT02434224|Procedure|Music Therapy|2 to 3 sessions per week of individualized creative music therapy
16062818|NCT02434211|Other|Questionnaire and focus group|
16062819|NCT02434172|Other|Pre-emptive screening and treatment for cryptococcal disease|Preemptive screening for cryptococcal disease among individuals with CD4 counts below 100 cells/mm3 with anti fungal therapy for those what are Cryptococcus antigen positive. These participants will be followed longitudinally for 12 months to determine clinical outcome, with their outcome compared with similar patients who are cryptococcal antigen negative, who will also be followed longitudinally for 12 months.
16062820|NCT02434159|Other|Heart scan|
16062821|NCT02434146|Drug|Topical Phenylephrine Solution|Given topically via spray
16062822|NCT02434133|Procedure|Blood Draw/Data Collection|Participation will involve an extra 8ml tube of blood and a review of their medical records for medications and immunization history.
16062823|NCT02434107|Procedure|Completion Lymphadenectomy|
16062824|NCT02434107|Procedure|Clinical Monitoring (Palpation and node ultrasound)|
16062825|NCT02434094|Behavioral|eDAPT on-line training program|A series of modules used to train on the web based training system for the artificial pancreas (AP) prototype, DiAs.
16062827|NCT02434068|Other|CT|followup
16062828|NCT02434055|Device|AVERT PLUS|
16062829|NCT02434042|Dietary Supplement|BB536|Intervention consists of daily administration of 1g probiotic Bifidobacterium longum BB536, administer daily for five days a week at a fixed dosage of 9 log CFU/day for BB536 and continue for 10 months.
16062830|NCT02434042|Other|Placebo|Intervention consists of daily administration of 1g of 100% dextrin, administer daily for five days a week and continue for 10 months.
16062831|NCT02434029|Drug|Budesonide 1mg orodispersible tablet twice daily|
16062832|NCT02434029|Drug|Placebo orodispersible tablet twice daily|
16062833|NCT02433977|Dietary Supplement|Conjugated Linolenic Acid|CLA is a polyunsaturated fatty acid Subjects will receive capsules for daily oral administration at the dose of 3 g/day
16062834|NCT02433977|Drug|Sodium Nitrite|Subjects will receive capsules for daily oral administration at the dose of 20 mg (2 x 10 mg)
16062835|NCT02433977|Drug|Sodium Nitrate|Subjects will receive capsules for daily oral administration at the dose of 1g (2 x 500 mg)
16062836|NCT02433964|Other|Grupo LED|
16062837|NCT02433964|Other|Placebo|ledterapia off + price
16062838|NCT02433951|Other|Cardiopulmonary exercise test|Maximal exercise test with ergospirometry.
16062839|NCT02433938|Procedure|Tibial nerve stimulation|patients underwent a three days postoperative transcutaneous tibial nerve stimulation
16062840|NCT02433938|Procedure|Sham tibial nerve stimulation|patients did not undergo a postoperative transcutaneous tibial nerve stimulation
16062841|NCT02433925|Dietary Supplement|Resveratrol|
16062842|NCT02433925|Dietary Supplement|Placebo|
16062843|NCT02433912|Procedure|Test - Laterally positioned flap|Laterally positioned flap. Systemic analgesics consisting of 750 mg of paracetamol was taken every six hours for four days. chlorhexidine gluconate (2.0%) gel applied in saturated cotton swabs twice a day for 14 days.
16062844|NCT02433912|Procedure|Control-Coronally positioned flap|Coronally positioned flap. Systemic analgesics consisting of 750 mg of paracetamol was taken every six hours for four days. chlorhexidine gluconate (2.0%) gel applied in saturated cotton swabs twice a day for 14 days.
16062845|NCT02433912|Drug|750 mg paracetamol|Systemic analgesics consisting of 750 mg of paracetamol was taken every six hours for four days
16062846|NCT02433912|Drug|chlorhexidine gluconate|chlorhexidine gluconate (2.0%) gel applied in saturated cotton swabs twice a day for 14 days
16062847|NCT02433899|Procedure|MICROSURGERY|Semilunar coronally repositioned flap performed under magnification with a surgical microscope
16062848|NCT02433899|Procedure|MACROSURGERY|Semilunar coronally repositioned flap performed without magnification
16062849|NCT02433899|Drug|Dexamethasone|8mg Dexamethasone, single dose, 1 hour before surgery
16062850|NCT02433899|Drug|Chlorhexidine gluconate|Oral rinses with chlorhexidine gluconate, BID, for 14 days
16062851|NCT02433899|Drug|2.0% Mepivacaine + 1:100.000 epinephrine|Regional block
16062853|NCT02433873|Dietary Supplement|Isomalto-oligosaccharide|Isomalto-oligosaccharide (IMO) is a non-digestible type of oligosaccharide commonly used as a low-calorie sweetener mixed with a variety of other food and beverage products for the purpose of sweetening.
16062854|NCT02433860|Behavioral|pharmacist nicotine cessation counseling using SCRIPT protocol|"Participant will be shown a short DVD Commit to Quit: During and After Pregnancy. She will be given a Pregnant Woman's Guide to Quitting booklet.
~Participant will be asked their nicotine use status and it will be confirmed with a CO meter test and cotinine urine test. Those not consenting to be part of the study will not receive the urinalysis.
~Participant will be advised to quit smoking. The pharmacist will review the Guide with the participant. The participant will receive a phone call around the time of their quit/reduction date. The participant will meet again approximately one week after their quit/reduction date and receive a CO meter test and urine cotinine test.
~At the end of the program pregnant women will answer a follow-up questionnaire. Those women participating in the research study will be given a cotinine urine test at approximately > 36 weeks gestation or at delivery."
16062855|NCT02433847|Drug|Mosapride|
16062856|NCT02433834|Drug|Glycopyrronium MDI|GP MDI
16062857|NCT02433834|Drug|Serevent Diskus 50 μg|
16062858|NCT02433834|Drug|Placebo|
16062859|NCT02433821|Other|Pilates|
16062860|NCT02433808|Drug|Neostigmine Group|Neostigmine will be used to reverse neuromuscular block at the conclusion of the surgical procedure. The effect on muscle strength will be determined using the TOF-Watch-SX and clinical examination
16062861|NCT02433808|Other|No Neostigmine group|Saline will be administered to patients at the end of the surgical procedure when neuromuscular function has recovered
16062862|NCT02433795|Drug|bendamustine plus rituximab|Bendamustine 90mg/m2 IV on days 1-2 up to 6th cycle Rituximab 375mg/m2 IV on day 1 at 1st cycle Rituximab 1400mg SC on day 1 from 2nd cycle every 4 weeks up to 8th cycle
16062863|NCT02433782|Other|Myofascial therapy|Maneuver of pressure and sliding over the anterolateral compartment of the leg Maneuver of pressure and sliding on the back of the leg Liberation technique of the popliteal fascia Maneuver of pressure and sliding on the anterior thigh Maneuver of pressure and sliding on the iliotibial tract Maneuver of pressure and sliding on the hamstring muscle region. Induction maneuver of ankle anterior compartment Induction maneuver of knee anterior chamber
16062864|NCT02433769|Device|TOFscan|"Data from the TOFscan will be compared to simultaneously measured data from the TOF-Watch-SX (gold standard)"
16062865|NCT02433769|Device|TOF-Watch-SX|Data from the TOF-Watch-SX will be compared to simultaneously measured data from the TOFscan
16062866|NCT02433756|Device|CRTD|
16062867|NCT02433743|Dietary Supplement|Ready-to-use therapeutic food (RUTF)|HIV-infected patients were randomly allocated to receive standard hospital diet (Control: n=33), or this diet combined with 100 g/day of RUTF (RUTF: n=32). All patients was follow-up during hospitalisation and 9 week after discharge at home
16062868|NCT02433730|Drug|Testosterone|intramuscular injection
16062869|NCT02433730|Drug|placebo|intramuscular injection
16062870|NCT02433717|Drug|Paliperidone ER|Fixed dose (9 mg/day) of paliperidone ER will be given in the first two weeks of trial (from day 1 to day 14). Since the third week (day 15), the dosage can be adjusted in the range of 6 to 12 mg per day.
16062871|NCT02433704|Device|New Intraosseous|Intraosseous administration of prophylactic antibiotics
16062872|NCT02433704|Drug|Cefazolin|Cefazolin 1 gram will be given through an intraosseous cannula, placed into the medial aspect of the proximal tibia, after draping and before skin incision. The cefazolin will be administered as a bolus in 200 mL of normal saline.
16062873|NCT02433691|Other|simultaneous aerobic exercise|stationary bicycling at 65% of heart rate reserve for 30 minutes while receiving memory training.
16062874|NCT02433691|Other|sequential aerobic exercise|stationary bicycling at 65% of heart rate reserve for 30 minutes followed by memory training.
16062875|NCT02433691|Other|stretching and toning|anaerobic stretching and toning followed by memory training.
16062876|NCT02433678|Drug|dapagliflozin|SGLT-2 inhibitor for the treatment of type 2 diabetes
16062877|NCT02433678|Drug|Placebo|
16062878|NCT02433665|Drug|Iopamidol|Iopamidol is the contrast material being used for this study. 100 subjects will receive a fixed dose and rate (150 mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of 3 mL/sec for a total dose of 45 grams of iodine) and 400 subjects will be administered a customized dose and rate (X mL of iopamidol with a concentration of 300 mg of iodine/mL at an injection rate of X mL/sec for a total dose of X grams of iodine).
16062879|NCT02433665|Device|Mydose|400 subjects will receive a customized dose of contrast material (iopamidol) based on the experimental algorithm Mydose using a combination of subject parameters.
16062880|NCT02433652|Biological|Recombinant live attenuated trivalent dengue vaccine|Contains 10^3.3 plaque forming units (PFU)/mL of rDEN1Δ30, 10^3.3 PFU/mL of rDEN3Δ30/31-7164 and 10^3.3 PFU/mL of rDEN4Δ30. It is administered in 0.5 mL containing 10^3.0 PFU of each component.
16062881|NCT02433652|Biological|Placebo|
16062882|NCT02433652|Biological|rDEN2Δ30-7169 vaccine|Live recombinant attenuated DENV-2 candidate vaccine virus; will be administered at a dose of 10^3 PFU
16062883|NCT02433639|Drug|TH-302 monotherapy|TH-302 (480 ) mg/m2 D1, D8, D15 Q 4 weeks
16062884|NCT02433626|Drug|COTI2|COTI-2 is a third generation thiosemicarbazone.
16062885|NCT02433626|Drug|Cisplatin|Cisplatin is approved to treat a range of solid tumors and lymphomas.
16062886|NCT02433600|Other|Cow's milk-based infant formula|
16062887|NCT02433600|Other|Cow milk-based infant formula with enriched protein fractions|
16062888|NCT02433587|Drug|Aspirin|Patients will take Aspirin 81 mg
16062889|NCT02433587|Drug|Clopidogrel|Patients will take Clopidogrel 75 mg
16062890|NCT02433574|Radiation|Neoadjuvant Stereotactic body radiation (SBRT)|"Dose escalation of neo-adjuvant SBRT in operable patients with locally advanced non-small cell lung cancer.
~The first cohort will be treated with a dose of 35 Gy in 10 fractions, the second cohort will be treated with a dose of 40 Gy in 10 fractions, the third cohort will be treated with a dose of 45 Gy in 10 fractions, the fourth cohort will be treated with a dose of 50 Gy in 10 fractions. The SBRT doses will be escalated only once all patients in the previous cohort will have completed safely their treatments."
16062891|NCT02433561|Procedure|Intraplexic catheter location (Contiplex® C, B. Braun Melsungen, AG)|The catheter tip will be placed with the aid of the ultrasound within the brachial plexus between C5 and C6
16062892|NCT02433561|Procedure|Extraplexic catheter location (Contiplex® C, B. Braun Melsungen, AG)|The catheter tip will be placed with the aid of the ultrasound 2 mm away from the lateral part of the brachial plexus
16062893|NCT02433548|Procedure|Fascia iliaca block|injection of 30 mLs below the fascia iliaca
16062894|NCT02433548|Procedure|Sham injection|subcutaneous of 5 cc of normal saline
16062895|NCT02433535|Drug|Simvastatin|Simvastatin is used to lower cholesterol, however, it also possess anti-inflammatory and immunomodulatory properties that may also alleviate allergic airway inflammation in asthma.
16062896|NCT02433535|Other|Placebo|A placebo pill will be given to the placebo group. There will be no detectible differences between study drug pill and placebo pill.
16062897|NCT02433522|Drug|rituximab|500 mg rituximab infusion at the randomization visit and every 6 months for 18 months. Each infusion will be preceded by an infusion of 1000 mg paracetamol, 100 mg methylprednisolone and 5 mg dexchlorpheniramine.
16062898|NCT02433522|Drug|Placebo|
16062899|NCT02433509|Other|HUCB monocyte cells|"The cord blood need to be infusion within less than 10 days after the onset of stroke, and the cord blood mononuclear cells 200 million ~ 500 million will used.
~20% mannitol 200 ml iv for 30±10 min/q8h±2h will be administered twice after cord blood infusion ."
16062900|NCT02433496|Other|Physician coaching|"The coach will present the latest research on the benefits and risks of long-term opioid use. The presentation will be followed by a brainstorming exercise where the coach joins the clinic team in experiencing clinical practices from the perspective of a patient with chronic pain. The coach will help the clinic team flowchart clinical workflows and determine the best course for implementing aspects of a checklist-based implementation guide developed to support adoption of the guidelines for opioid prescribing.
~The coach will help the team implement ideas using Plan-Do-Study-Act change cycles. The coach will maintain monthly email and phone contact with the clinic lead and clinic team after the initial site visit to monitor implementation progress and offer advice."
16062901|NCT02433483|Drug|Cytarabine|Given by either intrathecal (IT) or intravenous (IV) route.
16062902|NCT02433483|Drug|Intrathecal Triples|given IT.
16062903|NCT02433483|Biological|HPC-A|Given IV.
16062904|NCT02433470|Device|Transcranial direct current stimulation|Transcranial direct current stimulation over the motor cortex
16062905|NCT02433457|Drug|CC-292|
16062906|NCT02433457|Drug|Oral Omeprazole (OMP)|
16062907|NCT02433444|Procedure|Endoscopic retrograde cholangiopancreatography (ERCP)|ERCP's performed at Cedars-Sinai Medical Center.
16062908|NCT02433431|Behavioral|Mindfulness Training|Mindfulness training intervention consisting of 14 x 20-minute audio-guided lessons that participants access on their smartphones during the 14-day intervention period.
16062909|NCT02433431|Behavioral|Mindful Attention Only Training|Mindful attention training intervention consisting of 14 x 20-minute audio-guided lessons that participants access on their smartphones during the 14-day intervention period.
16062910|NCT02433431|Behavioral|Analytic Thinking Training|Comparison analytic thinking intervention consisting of 14 x 20-minute audio-guided lessons that participants access on their smartphones during the 14-day intervention period.
16062911|NCT02433418|Procedure|Tubal flushing by Urografin®|Women will have tubal flushing through HSG using water soluble media (Urographin ®)
16062912|NCT02433418|Drug|Diclofenac|Women will receive oral diclofenac 50 mg (voltaren ®) 1 hour before hysterosalpingography
16062913|NCT02433405|Biological|Fetuin-A|Acute phase protein
16062914|NCT02433405|Biological|Serum Amyloid A|Acute phase protein
16062915|NCT02433392|Procedure|CM-BC2|CM-BC2 is a drug-eluting bead, a drug-device combination
16062916|NCT02433379|Device|EMBLEM S-ICD System|The intervention comprises programming the EMBLEM Subcutaneous Implantable Defibrillator (S-ICD) with zone cutoffs at 200 bpm and 250 bmp
16062917|NCT02433353|Drug|Venlafaxine XR|Serotonin norepinephrine reuptake inhibitor
16062918|NCT02433353|Behavioral|EMDR|psychotherapy
16062919|NCT02433353|Drug|Placebo|Look-alike venlafaxine XR tablets containing no active drug
16062920|NCT02433340|Drug|ABT-122|
16062921|NCT02433327|Other|PEWS - trigger tool|PEWS - trigger tool A PEWS tool is a simple physiological scoring system that can be calculated at the patient's bedside, using parameters, which can easily be measured. Both PEWS tool consist of 7 parameters to be measured, and each individual measuring result would provide the patient with a score from 0-4. The 7 scores should then be added together giving the total PEWS. The children included into the study will be monitored using one of the two different PEWS models. Both model includes measuring vital signs with different intervals according to the child's conditions. Underlying both PEWS tool are algorithms of action for intervention in the critically ill child, interprofessional guidelines and guidance for standardised monitoring.
16062922|NCT02433327|Other|RM - trigger tool|RM - trigger tool A PEWS tool is a simple physiological scoring system that can be calculated at the patient's bedside, using parameters, which can easily be measured. Both PEWS tool consist of 7 parameters to be measured, and each individual measuring result would provide the patient with a score from 0-4. The 7 scores should then be added together giving the total PEWS. The children included into the study will be monitored using one of the two different PEWS models. Both model includes measuring vital signs with different intervals according to the child's conditions. Underlying both PEWS tool are algorithms of action for intervention in the critically ill child, interprofessional guidelines and guidance for standardised monitoring.
16062923|NCT02433314|Drug|SAGE-547|
16062924|NCT02433288|Other|Smart phone based patient support tool|The smart phone application used on the patients' smart phones will contain both the patient support tool and the questions for the clinical evaluation in the form of the Rosuvastatin Adherence questionnaire (RAQ), Beliefs about Medicine Questionnaire - General (BMQ-G), (Horne, 1999) and a Lifestyle questionnaire (LSQ) on disease understanding, lifestyle and treatment awareness. Patients in the Active group will also receive feedback on their daily rosuvastatin treatment as entered in the patient support tool.
16062925|NCT02433288|Other|Control application: only for data collection|the patients will have no access to the smart phone-based patient support tool. However, a smart phone application will be used to prompt patients with the questions for the clinical evaluation (RAQ, BMQ-G and LSQ).
16062957|NCT02433041|Drug|Ketamine|Ketamine 1mg/kg at induction of anesthesia to test its power to prevent postoperative delirium
16063062|NCT02432365|Drug|cisplatin|7-day cycle schedule of cisplatin (40 mg/m2)
16062926|NCT02433262|Other|WHO (World Health Organisation)|Participants will need to undergo oral glucose tolerance test which involve drinking a 75g oral glucose. Venous blood for fasting and 2 hours post glucose intake will be taken. Diagnosis of gestational diabetes mellitus (GDM) will be made using WHO criteria. Once GDM is diagnosed, they will undergo blood sugar profile monitoring and treatment which includes diet control and/or insulin treatment if required
16062927|NCT02433262|Other|IADPSG|Participants will need to undergo oral glucose tolerance test which involve drinking a 75g oral glucose. Venous blood for fasting and 2 hours post glucose intake will be taken. Diagnosis of gestational diabetes mellitus (GDM) will be made using IADPSG criteria. Once GDM is diagnosed, they will undergo blood sugar profile monitoring and treatment which includes diet control and/or insulin treatment if required
16062928|NCT02433249|Behavioral|1 Physical Activity|Fall reducing strength (5), balance (12) and flexibility (4) exercises as well as walking. Participants were also given a Fitbit One with instructions on how to use
16062929|NCT02433249|Behavioral|Interpersonal Motivation|Strategies used to support Interpersonal motivational targets include: a) discuss and model ways to provide and receive more support for physical activity, b) identify environmental barriers to being physically active, c) problem-solve environmental and social barriers to being physically active, d) use and create new resources that support physical activity behavior
16062930|NCT02433249|Behavioral|Intrapersonal Motivation|Strategies used to support intrapersonal motivation included a) use of the goal attainment scale, b) facilitating the formation of action plans, c) identify and problem solve personal barriers to being active, d) identify satisfying aspects of being active, e) self-evaluate physical activity patterns and progress.
16062931|NCT02433236|Drug|Fostamatinib Disodium tablet 100 mg|
16062932|NCT02433236|Drug|Fostamatinib Disodium tablet 150 mg|
16062933|NCT02433210|Device|ELISIO-15H|Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
16062934|NCT02433210|Device|Revaclear|Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
16062935|NCT02433210|Device|Optiflux|Each patient to undergo 3 successive hemodialysis/week with this dialyzer.
16062936|NCT02433197|Device|Aerobic program|"The intervention will be an 8-week program of individualized physiotherapy strength and muscular endurance with aerobic training, led by physiotherapists in groups of 8-10 participants. Each program will be individualized based on the evaluations of muscular strength and enduranceas well as determination of aerobic-anaerobic zone transition described in previous studies In sessions of one hour 3 times a week. Each session will consist of 30 minutes of exercises performed on land followed by 20 minutes of continuous running in treadmill.
~In week 1 and 2 participants carry out 3 sets of 15 repetitions (reps) to become familiar with the exercises. From week 3 onwards participants will perform 4 sets of 10 reps. If the participant can do more than 12 reps, weight will be increased. All exercises are conducted supervised to ensure proper technique and adequate progression."
16062937|NCT02433184|Drug|Etanercept|Etanercept will be administered subcutaneously at a dose of 50 mg weekly and will be discontinued at the primary endpoint (48 weeks).
16062938|NCT02433184|Drug|Methotrexate|Methotrexate will be administered orally at a starting dose of 15 mg and will be increased to 25mg weekly at 2 weeks.
16062939|NCT02433184|Drug|Sulfasalazine|Sulfasalazine will be added at weeks 8,12,16 or 20 if the subject fails to achieve low disease activity, administered orally at a dose of 1g twice daily. Will be discontinued if starting etanercept at 24 weeks.
16062940|NCT02433184|Drug|Hydroxychloroquine|Hydroxychloroquine will be added at weeks 8,12,16 or 20 if the subject fails to achieve low disease activity, administered at a dose of 200mg daily. Will be discontinued if starting etanercept at 24 weeks.
16062941|NCT02433184|Drug|Etanercept|Etanercept will be added at 24 weeks, if a subject fails to achieve clinical remission,at a dose of 50 mg weekly and will be discontinued at 48 weeks with the exception of those patients who are eligible to continue according to local prescribing guidelines (NICE guidelines)
16062942|NCT02433184|Drug|Methotrexate|Methotrexate will be administered orally at a starting dose of 15 mg weekly, increasing to 20mg and 25mg weekly at weeks 4 and 8 respectively.
16062943|NCT02433171|Procedure|Standard of Care FDG-PET Imaging|[11C]Methionine [11]. This natural amino acid, and its various fluorinated derivatives, has been widely used in brain tumor studies due to a) high tumor-to-normal brain contrast, and b) its sensitivity to biological functions including amino acid transport and utilization. [11C]PBR28 [12]. This ligand is one of a series of second-generation tracers that bind to TSPO (translocator protein), a protein that is upregulated in activated microglia.
16062944|NCT02433158|Drug|Rivipansel|Rivipansel will be infused intravenously every 12 hours up to a maximum of 15 doses.
16062945|NCT02433132|Other|Nasal brushing|The CCBN test is to evaluate the ion transport in the nasal epithelial cells taken from a subject by brushing the inferior turbinate with a mini-brush after local anesthesia. Analysis of ion transport is carried out ex vivo on the primary culture of nasal epithelial cells after brushing
16062946|NCT02433119|Drug|OROSARTAN® 5/160mg|
16062947|NCT02433119|Drug|CODIOVAN® 160/12.5mg|
16062948|NCT02433106|Other|GAA 15|Neuromuscular injury prevention training
16062949|NCT02433106|Other|Control|Usual training
16062950|NCT02433093|Drug|Basimglurant|Participants will receive once-daily oral basimglurant capsules in a multiple ascending dose regimen. Basimglurant dose will be titrated over 22 days; dose escalations will be separated by at least 4 days, with the final dose administered for a minimum of 14 days. The minimum starting dose will be 1.5 mg, which can be titrated up to a maximum dose of 4.0 mg. Intrapatient dose increments will not exceed 1.0 mg every 4 days.
16062951|NCT02433093|Drug|Placebo|Participants will receive 22 days of once-daily oral matching placebo capsules.
16062952|NCT02433080|Behavioral|Shape-Up following cancer treatment|"The programme is based on Social Cognitive Theory and Control Theory. The focus of the programme lies on self-control, self-efficacy, and relapse prevention."
16062953|NCT02433067|Other|Physical activity intervention|Patients in arm A (interventional) will carry out a physical activity intervention during 3 months. Patients should perform an interval training program on cycle-ergometer during 3 sessions per week.
16062954|NCT02433067|Other|Control Group|standard oncologic care
16062955|NCT02433054|Device|CE-certified dedicated venous stents|Implantation of self-expanding nitinol venous stents in the iliofemoral veins and/or inferior vena cava.
16062956|NCT02433041|Drug|Haloperidol|Haloperidol 0.005mg/kg at induction of anesthesia
16062958|NCT02433041|Drug|Haloperidol + Ketamine|Haloperidol 0.005mg/kg + Ketamine 1mg/kg at induction of anesthesia to test their power to prevent postoperative delirium if given together
16062959|NCT02433041|Drug|Saline solution (NaCl 0.9%)|Placebo being used in one of the four groups
16062960|NCT02433015|Other|Electronic Cigarette|eGo-type electronic cigarette with a supply of 18mg/ml nicotine solution
16062961|NCT02433015|Other|Tobacco Cigarette|Smoke own brand of cigarette as previously
16062962|NCT02432989|Behavioral|Exercise|Light-moderate exercise on a stationary bike and leisurely walks.
16062963|NCT02432976|Drug|Exenatide|"Exenatide. Exenatide: bolus of 0.05 µg/min infused during the 1st hour of treatment, followed by a continuous infusion of 0.025 µg/min until the end of treatment.
~The exenatide therapy will begin as soon as a blood glucose level is above 140 mg/dl will be measured. A of exenatide will be intravenously .
~The treatment will be administrated during the first postoperative 48 hours in the intensive care unit or until intensive care unit discharge if this event occurs earlier."
16062964|NCT02432976|Drug|Insulin|"Insulin: Humalog (insulin lispro human analog). The insulin therapy will begin as soon as a blood glucose level is above 140 mg/dl will be measured.
~The dose of insulin intravenously infused will be adapted to blood glucose measurements, following the insulin therapy protocol used in our department.
~The insulin therapy protocol used in our department and prescribed as the benchmark treatment in the present study has been validated in a previous study. It has been derived from the protocol validated by Goldberg et al."
16062965|NCT02432963|Other|Laboratory Biomarker Analysis|Correlative studies
16062966|NCT02432963|Biological|Modified Vaccinia Virus Ankara Vaccine Expressing p53|Given SC
16062967|NCT02432963|Biological|Pembrolizumab|Given IV
16062968|NCT02432950|Dietary Supplement|Dietary Intervention|Participate in the PNP
16062969|NCT02432950|Other|Educational Intervention|Participate in the PNP
16062970|NCT02432950|Other|Laboratory Biomarker Analysis|Correlative studies
16062971|NCT02432950|Other|Quality-of-Life Assessment|Ancillary studies
16062972|NCT02432937|Drug|Corever|Corever
16062973|NCT02432924|Behavioral|Instant + Multidimensional Physical Activity Feedback|
16062974|NCT02432911|Drug|CAG regimen (Aclacinomycin, cytarabine, with/w/o G-CSF)|Aclacinomycin 20mg/d for 4 days combined with cytarabine 20mg bid for 10 days with/without G-CSF 6ug/m2 from 1 day before therapy to day 10 of therapy.
16062975|NCT02432911|Drug|low dose cytarabine|cytarabine 20mg bid for 10 days.
16062976|NCT02432898|Device|3D OCT-1|Spectral Domain OCT Device
16062977|NCT02432898|Device|3D OCT-2000|Spectral Domain OCT Device
16062978|NCT02432898|Device|DRI OCT-1|Swept Source OCT Device
16062979|NCT02432898|Device|NW-300|Fundus Camera
16062980|NCT02432898|Device|CT-1P|Tonometry
16062981|NCT02432898|Device|TRK-2P|Tonometry, Corneal Topography
16062982|NCT02432898|Device|SP-1P|Specular Microscopy
16062983|NCT02432898|Device|SL-D701|Slit Lamp Imaging
16062984|NCT02432898|Device|MC-4S|Visual Acuity Testing
16062985|NCT02432885|Drug|Enalapril|up to 20mg bid
16062986|NCT02432872|Drug|Daunorubicin|defferent doses of daunorubicin,that is 60mg/m2 for 3 doses compared with 45mg/m2 for 3 doses
16062987|NCT02432872|Drug|Cytarabine|medium dosage cytarabine（1 g/m2 q12h for 3 days) compared with standard dosage cytarabine(100mg/m2 per day for 6 days)combinated with aclacinomycin（20mg per day for 6 days）for consolidation therapy.
16062988|NCT02432859|Procedure|Electrical Stimulation|Direct current with sensory intensity for one hour
16062989|NCT02432859|Procedure|Placebo|Direct current with zero intensity for one hour
16062990|NCT02432846|Biological|Intuvax (INN: ilixadencel)|Therapeutic dose (10 million cells/dose): allogeneic, pro-inflammatory dendritic cells.
16062991|NCT02432846|Drug|Sunitinib|Cytostatic/cytotoxic drug: protein kinase inhibitor .
16062992|NCT02432833|Drug|ENVARSUS®|Envarsus® tablets, once daily, oral formulation. Prolonged -release formulation of tacrolimus
16062993|NCT02432833|Drug|PROGRAF®|Prograf® hard capsules, twice daily, oral formulation
16062994|NCT02432833|Drug|ADVAGRAF®|Advagraf® prolonged-release hard capsules, once daily, oral formulation
16062995|NCT02432807|Drug|Vancomycin 1.1%|Vancomycin hydrochloride ophthalmic ointment 1.1%
16062996|NCT02432807|Drug|Placebo|Placebo
16062997|NCT02432794|Procedure|delay phenomenon by arteriographic approach|we improve the microvascularization of the gastric fundus occluding the right and left gastric artery, and splenic artery two weeks before surgery by arteriography
16062998|NCT02432781|Dietary Supplement|Carbohydrate-rich drink|
16062999|NCT02432781|Dietary Supplement|10% dextrose solution mixed with insulin 16 unit 100 mL/h|
16063000|NCT02432768|Drug|Triheptanoin|Anaplerotic dietary oil
16063001|NCT02432768|Other|Placebo oil|Safflower oil
16063002|NCT02432755|Behavioral|home-based MTOT|The home-based MTOT group will receive 30 minutes of MT followed by 30 minutes of TOT per session. The intervention will take place in the participant's home environment. During the mirror practices, the patient will seat close to a table which the mirror box will be placed at the mid-sagittal plane. During MT, the participant will be encouraged to actively move their paretic arm and hand concurrently with the mirror reflection of the movement of the nonparetic arm and hand as possible as they can. If necessary, the therapist will assist the participant in moving the paretic hand to synchronize the movement with the nonparetic hand.
16063003|NCT02432755|Behavioral|hospital-based therapy|The control group will receive a dose-matched, individualized occupational therapy at a hospital. The participants will receive customary rehabilitation programs as usual performed at hospitals for 1 hour per session. The treatment protocol will include: (a) passive range of motion exercises, stretching of the affected limb, or facilitatory and inhibitory techniques, (b) fine motor or dexterity training, (c) arm exercises or gross motor training, (d) muscle strengthening of the affected upper limb, and (e) activities of daily living training or functional task practice.
16063059|NCT02432378|Biological|Cisplatin + celecoxib + DC vaccine|Cisplatin 50 mg/m2 by IP once per cycle (21 days) + celecoxib daily 200 mg by mouth daily + intranodal vaccine injections once per cycle
16063060|NCT02432378|Biological|Cisplatin + CKM + Celecoxib + DC Vaccine|Cisplatin 50 mg/m2 by IP once per cycle (21 days) + celecoxib daily 200 mg by mouth daily + IFN by IP once per cycle + rintatolimod 200 mg by IP once per cycle + intranodal vaccine injections once per cycle
16063004|NCT02432755|Behavioral|hospital-based MTOT|The hospital-based MTOT group will also receive 30 minutes of MT followed by 30 minutes of TOT per session at a hospital. The intervention will take place in the occupational therapy clinic. The treatment modalities in the hospital will be selected and provided for this group. Most of the treatment principles and components are the same as aforementioned in the home-based MTOT. However, the major differences between home-based and hospital-based MTOT are the treatment contexts, environments and functional modalities used.
16063005|NCT02432742|Device|Restylane Perlane|Intradermal injection
16063006|NCT02432742|Device|Restylane|Intradermal injection
16063007|NCT02432716|Drug|Insulin glulisine|Insulin (glulisine) Glulisine 20 IU/IN (.1ml/10 units intranasal in each nostril), once per study
16063008|NCT02432716|Drug|Saline|Placebo Comparator: Placebo Sterile Normal Saline 20 IU/IN (.1ml intransal in each nostril), once per study
16063009|NCT02432703|Drug|JNJ-42165279|Participants will receive 25 milligram (mg) JNJ-42165279 orally once-daily from Day 1 up to 12 weeks.
16063010|NCT02432703|Drug|Placebo|Participants will receive a matching placebo orally once-daily from Day 1 up to 12 weeks.
16063011|NCT02432690|Drug|BBI503|BBI503 will be administered orally, once daily. Dosing will begin at 200 mg once daily, preferably at bedtime and 2 hours after a meal. Dose modification in case of adverse events is allowed according to the schedule below; Full dose: 200 mg daily, Modification Level-1: 100 mg daily, Modification Level-2: 50 mg daily.
16063012|NCT02432677|Drug|Remifentanil|Remifentanil (IV infusion): 0,06mcg.kg.min. The infusion starts 10min before tDCSThe infusion will be stopped in the event of: a decrease in respiratory rate below 7 breaths / min, a peripheral oxygen saturation below 85%, a lower heart rate of 40 beats per minute, a lower mean arterial pressure of 60 mmHg, sedation causing inadequate management switch stimuli tests and occurrence of vomiting.
16063013|NCT02432677|Device|Active tDCS|The stimulation will be administered with a pair of surface electrodes, sponge coated, soaked in saline. A battery-powered constant current stimulator will be used for this purpose (tDCS device). The stimulation is performed by placing the anodal electrode in the primary motor cortex (M1) and the cathodal one in the contralateral supraorbital area and it will use a 2 mA (milliampere) current.
16063014|NCT02432677|Device|Sham tDCS|The sham tDCS consists in the same montage of the active tDCS, but the device is turned off 30 seconds after starting stimulation (without letting the patient notice it). The rest of the montage is kept identical to the active one during the 20 minutes session.
16063015|NCT02432677|Drug|Placebo|Saline infusion - Infusion 10min before the tDCS session, during the tDCS session and after the tDCS session, until the end of pain tests.
16063016|NCT02432664|Drug|ODM-108 Part I|Single oral escalating dose of ODM-108. Each volunteer will receive either one dose of ODM-108 or placebo
16063017|NCT02432664|Drug|Placebo Part I|Single oral escalating dose of ODM-108. Each volunteer will receive either one dose of ODM-108 or placebo
16063018|NCT02432664|Drug|ODM-108-Part II|Multiple escalating doses based on the results of Part 1. Either ODM-108 or placebo 1 - 4 times a day for 7 days
16063019|NCT02432664|Drug|Placebo Part II|Multiple escalating doses based on the results of Part 1. Either ODM-108 or placebo 1 - 4 times a day for 7 days
16063020|NCT02432664|Drug|ODM-108 Part III|Oral capsules 1 - 4 times daily for 7 to 10 days
16063021|NCT02432664|Drug|Midazolam|Single dose as a solution 3 days prior to the first dose of ODM-108 and on the last day of dosing with ODM-108
16063022|NCT02432651|Drug|6 mg xanthohumol per day|Participants will consume non-alcoholic beverage with 2 mg xanthohumol at breakfast, lunch and dinner for 3 weeks.
16063023|NCT02432651|Drug|12 mg xanthohumol per day|Participants will consume a non-alcoholic beverage with 2 mg xanthohumol at breakfast and lunch and 8 mg at dinner for 3 weeks.
16063024|NCT02432651|Drug|24 mg xanthohumol per day|Participants will consume a non-alcoholic beverage with 8 mg xanthohumol at breakfast, lunch and dinner for 3 weeks.
16063025|NCT02432651|Drug|Placebo|Participants will consume a placebo non-alcoholic beverage (0 mg xanthohumol) at breakfast, lunch and dinner for 3 weeks.
16063026|NCT02432612|Drug|Sativex|Sativex is supplied as a liquid containing 27 mg/mL Δ9-tetrahydrocannabinol (THC) and 25 mg/mL Cannabidiol (CBD) plus peppermint flavoring. Each 100 µL actuation of the pump-action spray delivers 100 µL 27 mg THC and 25 mg CBD.
16063027|NCT02432599|Radiation|F18-choline PET examination|F18-choline PET examination will be performed before surgery
16063028|NCT02432586|Behavioral|Intensive Education|Participants will attend a 3 day family-centered, multidisciplinary, intensive education session at our regional diabetes camp, Camp Sweeney. A second 'booster' session will be conducted 6 months later.
16063029|NCT02432573|Behavioral|Delayed rounds|
16063030|NCT02432560|Drug|Sirolimus|Sirolimus treatment will be part of a participant's clinical care and will be managed by their physician.
16063031|NCT02432560|Drug|Everolimus|Everolimus treatment will be part of a participant's clinical care and will be managed by their physician.
16063032|NCT02432547|Drug|Aflibercept|Aflibercept is a soluble decoy receptor and is produced by fusing all-human DNA sequences of the second immunoglobulin (Ig) domain of human VEGF receptor (VEGFR) 1 to the third Ig domain of human VEGFR-2, which are then fused to the Fc region of human IgG-1. By binding to VEGF-A, aflibercept prevents activation of the native VEGF receptors, VEGFR-1 and VEGFR-2. The study sites will be supplied by Bayer with aflibercept. Intravitreal injection of 2mg in 0.05 ml aflibercept will be administered to the study eye, according to a pre-defined treat and extend regimen.
16063033|NCT02432547|Procedure|Targeted laser therapy|In the experimental group, targeted laser photocoagulation will be applied to areas of peripheral retinal ischaemia 1 month after the initial intravitreal aflibercept. The trial design allows another session of targeted laser photocoagulation 1 month later to complete the treatment if required. Wide-field photography is planned at 3 months to determine if further targeted laser photocoagulation is required, and if so a third session can be applied. The laser settings are based on those used in current clinical practice and have been prospectively defined in the protocol.
16063034|NCT02432534|Drug|Atorvastatin|The patients will be treated with the combination of oral atorvastatin and NBUVB phototherapy twice a week for 6 months. The initial starting dose of the oral atorvastatin will be 40mg daily and after 1 month, if tolerated clinically and biologically following blood tests, the dose will be increased to 80mg daily.
16063035|NCT02432534|Other|UVB|The patients will be receiving only NB-UVB phototherapy twice a week for 6 months.
16063111|NCT02432014|Behavioral|PMTO-PTC Group clinic-based|
16063036|NCT02432521|Other|Conventional rehabilitation program from IMREA|The IMREA rehabilitation program lasts about 18 weeks and consists of two weekly sessions of 60 minutes of physical therapy, occupational therapy, as well as weekly sessions of speech therapy, nursing, nutrition, psychology and social work. Conventional therapies are typically composed of stretching and strengthening exercises both upper and lower limbs, mobilizations, functional training. The only fact that differ the subjects from the protocol from the patients from the IMREA Institute are the clinical and neurophysiological evaluations that will be performed before and after the end of the conventional rehabilitation program previously described.
16063037|NCT02432508|Device|Laser acupuncture (Olympic)|Physiolaser Olympic laser acupuncture device (50mW, 655nm)
16063038|NCT02432508|Device|Sham Laser acupuncture (Olympic)|Physiolaser Olympic laser acupuncture device (Low dose of laser energy: 5mW, 655nm)
16063039|NCT02432495|Other|ANTERIOR SCREW FIXATION|Patients aged 65 years or older with an ASA score of 2 or higher who had undergone anterior screw fixation of type II odontoid fractures
16063040|NCT02432495|Other|HALOV VEST IMMOBILIZATION|Patients aged 65 years or older with an ASA score of 2 or higher who had undergone halo immobilization of type II odontoid fractures
16063041|NCT02432482|Behavioral|mobile Positively Smoke Free (mPSF)|mPSF is a targeted, intensive behavioral cessation intervention designed for HIV-infected smokers. It is guided by the Social Cognitive Theory model. It includes 8 weekly sessions of audio/video messages to users, daily text messages, and a variety of other smartphone capabilities, e.g. play-a-tune, play-a-game, phone-a-friend, call the quitline.
16063042|NCT02432482|Behavioral|Standard care|Brief advice to quit (<5 minutes) Self-help brochure Offer of nicotine patches
16063043|NCT02432469|Behavioral|APP intervention|The APP contains education materials about secondary intervention of coronary artery disease, patients can surf and read them very easily. The APP also collects information on medication prescription by doctors, reminds patients at every time of taking medications, and asks for feedback from patients at 8 pm every day. The APP also pushes a patient-specific questionnaire with 10-15 questions weekly, to collect information about patients' medication adherence and self-management on blood pressure, blood lipid, blood glucose, physical activity, diet and body weight. APP pushes series of recommendations right after patients' finishing the questionnaire to help them improve their secondary prevention.
16063044|NCT02432456|Drug|Ketamine|All individuals randomized to the experimental arm of the trial will receive early ketamine therapy (within 6 hours of admission) at a rate of 0.15 mg/kg/hr dosed based on ideal body weight. Individuals in the control arm will receive our standard of care for thoracic trauma patients, however, they will receive an additional placebo infusion of normal saline.
16063045|NCT02432456|Drug|Placebo|Individuals enrolled into the control arm of the trial will receive a normal saline placebo infusion at a rate equivalent to the dosage of ketamine in the experimental arm.
16063046|NCT02432456|Procedure|Intercostal Nerve Block|All individuals enrolled into the trial will undergo an Intercostal Nerve Blockade as a part of the institutional standard of care for rib fractures. This procedure will be performed according to current standard protocols in the Emergency Department or on admission.
16063047|NCT02432456|Drug|Acetaminophen|All patients admitted to the hospital will be placed on scheduled acetaminophen 1000mg PO q 6 hours unless signs of liver disease/impairment or creatinine clearance < 35ml/min at which point dosage would be reduced to 650mg q 8 hours. Individuals unable to take oral medications would be placed on intravenous acetaminophen.
16063048|NCT02432456|Drug|Ibuprofen|All patients will be placed on scheduled Ibuprofen or an equivalent NSAID at dosage of 600mg every 6 hours. Patients must have a Glomerular Filtration Rate > 60 ml/min with no contraindications to NSAID therapy (e.g. Aspirin use, allergy/sensitivity, concurrent ACE inhibitor use, other nephrotoxins, etc)
16063049|NCT02432456|Drug|Pantoprazole|All individuals on scheduled Non-Steroidal Anti-Inflammatory Drug (NSAID) therapy will receive scheduled pantoprazole at 40mg daily. Individuals unable to take medications orally will be placed on intravenous therapy. Individuals with previous reaction or intolerance to pantoprazole will be placed on an equivalent proton pump inhibitor.
16063050|NCT02432456|Drug|Methocarbamol|All individuals enrolled in the trial will be placed on scheduled methocarbamol 500 mg orally every 6 hours while admitted. Individuals with previous intolerance to methocarbamol will be placed on a pharmacy directed equivalent.
16063051|NCT02432456|Drug|Opioid|"All individuals will receive as needed opiate therapy as an adjunct to the scheduled medications and ketamine/placebo solution. Choice in opiate therapy will be at the discretion of the attending trauma faculty. Dosage and adjustments will be in accordance with the institutional policy on appropriate opiate dosage adjustment."
16063052|NCT02432443|Behavioral|Motor and pre-literacy program|The program will run for 60 minutes once per week for 10 consecutive weeks and will consist of three components: direct FMS instruction, unstructured exploratory free-play, and an interactive storybook reading activity. The curriculum and teaching strategies to be used for the first two segments of our intervention have been successfully implemented in previous research to improve the motor skills of 4 year old children with autism (Bremer, Balogh, & Lloyd, 2014). Specific strategies and books were selected from an existing evidence-based curriculum (Justice & McGuinty, 2009). There will be active involvement of at least one parent in the direct instruction and reading components.
16063053|NCT02432443|Other|Wait-list Comparison|The participants will not participate in the motor and pre-literacy program for 10 weeks after enrollment and will continue with their normal daily life without any intervention. After the experimental arm completes the motor and pre-literacy program, the wait-list group will receive the exact same motor and pre-literacy intervention.
16063054|NCT02432430|Behavioral|QI support to improve DTP/Hep B/MMR/Var/PCV/Hib/IPV coverage|Quality improvement technical support to help providers' ability to institute best practices to improve delivery of the following vaccines: DTP, HepB, MMR, Var, PCV, Hib, IPV
16063055|NCT02432430|Behavioral|Incentives to improve DTP/HepB/MMR/Var/PCV/Hib/IPV coverage|Financial incentives to support to help providers' ability to institute best practices to improve delivery of the following vaccines: DTP, HepB, MMR, Var, PCV, Hib, IPV
16063056|NCT02432417|Drug|Chloroquine|CQ will start with one week before the start of radiotherapy and end on the last day of radiotherapy.
16063057|NCT02432404|Drug|NuvaRing|
16063058|NCT02432391|Behavioral|GEM|GEM is an integrated lifestyle modification program that focuses on reducing postprandial blood glucose through replacing high with low glycemic load foods and increasing routine physical activity guided by systematic blood glucose monitoring.
16063063|NCT02432365|Procedure|Radical hysterectomy and bilateral pelvic lymphadenectomy|2 weeks after last course of neoadjuvant chemotherapy
16063064|NCT02432352|Behavioral|Our Family Our Future|The Our Family Our Future Program is a family preventive intervention that uses resilience and prevention focused strategies to reduce sexual risk behaviors and build mental wellbeing among adolescents.
16063065|NCT02432339|Drug|mycophenolate mofetil (MMF)|an immunosuppressant - 500 mgs twice a day for 7 1/2 days - in capsule form
16063066|NCT02432339|Drug|Placebo|a sugar pill - 500 mgs twice a day for 7 1/2 days - in the same capsule form as the MMF
16063067|NCT02432326|Drug|BBI608|The BBI608 starting dose is 240 mg twice daily (480 mg total daily). Dose will be decreased to 160 mg twice daily (320 mg total daily) at modification level 2 and 80 mg twice daily (160 mg total daily) at modification level 3. For BBI608 once daily dosing, doses at starting level and modification level 1 are 240 mg once daily, and 480 mg once daily at escalated levels. Dose will be decreased to 160 mg once daily at modification level 2 and 80 mg once daily at modification level 3.
16063068|NCT02432326|Drug|BBI503|The BBI503 starting dose is 200 mg once daily. Dose at modification level 1 to 3 will be 100 mg once daily.
16063069|NCT02432313|Drug|Modified Release Formulation x (MRx)|Subject receives 1 dose of a MRx and is followed. 7-day washout before dosing with another formulation
16063070|NCT02432300|Behavioral|Emotion Builder|Total of 8 therapy sessions with the Emotion Builder over approximately four (4) weeks (2 sessions a week)
16063071|NCT02432287|Drug|Metformin|To determine if treatment with metformin (1700 mg/day) will restore the gene expression profile of older, glucose intolerant adults to that of young healthy subjects.
16063072|NCT02432287|Drug|Placebo|there is no other name we used for the placebo
16063073|NCT02432274|Drug|Lenvatinib|Cohort 1: Lenvatinib will be administered orally, once daily on Days 1 to 28 of each 28-day cycle at a starting dose of 11 mg/m2. Dose can be de-escalated to 9 mg/m2 or escalated to 14 and 17 mg/m2.
16063074|NCT02432274|Drug|Lenvatinib|Cohort 2A: Lenvatinib (RD determined in Cohort 1) will be administered orally, once daily on Days 1 to 28 of each 28-day cycle.
16063075|NCT02432274|Drug|Lenvatinib|Cohort 2B: Lenvatinib (RD determined in Cohort 1) will be administered orally, once daily on Days 1 to 28 of each 28-day cycle.
16063076|NCT02432274|Drug|Lenvatinib|Cohort 3A: Lenvatinib will be administered orally, once daily on Days 1 to 21 of each 21-day cycle at 20% lower than RD determined in Cohort 1 (starting dose). Lenvatinib dose can be escalated to the RD from Cohort 1 or de-escalated to 40 and 60% lower than the RD from Cohort 1.
16063077|NCT02432274|Drug|Lenvatinib|Cohort 3B: Lenvatinib will be administered orally, once daily on Days 1 to 21 of each 21-day cycle at the RD as determined in Cohort 3A.
16063078|NCT02432274|Drug|Ifosfamide|Ifosfamide 3000 mg/m2/day (starting dose) will be administered on Days 1 to 3 of each 21-day cycle for a total of 5 cycles. Ifosfamide dose can be de-escalated to 2400 mg/m2/day and 1800 mg/m2/day.
16063079|NCT02432274|Drug|Etoposide|Etoposide 100 mg/m2/day (starting dose) will be administered on Days 1 to 3 of each 21-day cycle for a total of 5 cycles. Etoposide dose can be de-escalated to 80 mg/m2/day and 60 mg/m2/day.
16063080|NCT02432274|Drug|Ifosfamide|Ifosfamide dose identified in Cohort 3A will be administered on Days 1 to 3 of each 21-day cycle for a total of 5 cycles.
16063081|NCT02432274|Drug|Etoposide|Etoposide dose identified in Cohort 3A will be administered on Days 1 to 3 of each 21-day cycle for a total of 5 cycles.
16063082|NCT02432261|Drug|Nestorone® /testosterone gel|Nestorone® /testosterone combined gel
16063083|NCT02432261|Drug|Testosterone only gel|Testosterone only gel
16063084|NCT02432248|Drug|Dehydroepiandrosterone|75mg/day, PO for 90 days
16063085|NCT02432248|Other|placebo(medical starch)|75mg/day, PO for 90 days
16063086|NCT02432235|Drug|Camidanlumab tesirine|Intravenous (IV) infusion.
16063087|NCT02432222|Behavioral|Visual Arts Training|Visual arts training
16063088|NCT02432222|Behavioral|Music Training|Music training
16063089|NCT02432209|Other|Caloric Restriction|Subjects on Active comparator will have Caloric Restriction to a 1200-1500 kcal/day diet through use of Nutrisystem Meal Plan.
16063090|NCT02432209|Drug|Orlistat|Subjects on Active comparator will use an over-the-counter weight loss medication, Orlistat, a gastric lipase inhibitor that limits gut fat absorption.
16063091|NCT02432209|Other|Moderate physical activity|All subjects in both arms will be encouraged to engage in moderate physical activity with target of 10,000 steps a day.
16063092|NCT02432196|Device|Harpoon Medical Device|It is expected that the Harpoon Medical transapical suturing device will be a valuable treatment alternative for patients suffering from mitral valve regurgitation because it can access the left ventricle with a small shaft or via a small valved introducer with a secure anchoring mechanism that can be deployed anywhere on the mitral valve leaflet.
16063093|NCT02432170|Device|Digital Tomosynthesis of Foot and Ankle|Imaging Technique
16063094|NCT02432157|Drug|HTS 3%|3% HTS at a dose of 250 ml every 6 hours for 7 days
16063095|NCT02432157|Drug|Standard fluid management|Routine fluid management strategy as pre-specified by our SAH management protocol.
16063096|NCT02432144|Drug|UX003|solution for intravenous (IV) infusion
16063097|NCT02432118|Procedure|Lumpectomy|Undergo lumpectomy
16063098|NCT02432118|Other|Questionnaire Administration|Ancillary studies
16063099|NCT02432118|Procedure|Radiofrequency-Guided Localization|Undergo radiofrequency-guided localization
16063100|NCT02432105|Drug|EXE844 Sterile Otic Suspension, 0.3%|
16063101|NCT02432105|Procedure|Tympanostomy Tube Insertion|Surgical procedure for treating pediatric cases of recurrent or chronic otitis media
16063102|NCT02432066|Drug|GTS-21|GTS-21 is a partial alpha7 nicotinic agonist. GTS-21 will be compounded by the UF investigational pharmacy, and administered orally.
16063103|NCT02432066|Drug|Placebo|Oral placebo pills, compounded by the UF investigational pharmacy
16063104|NCT02432053|Drug|Advagraf|
16063105|NCT02432040|Drug|Atorvastatin|Atorvastatin is a hydroxymethylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor used to treat dyslipidemia
16063106|NCT02432040|Drug|Placebo|Placebo tablets, made to look like the interventional drug
16063107|NCT02432027|Drug|C-82 Topical Gel, Placebo|placebo
16063108|NCT02432027|Drug|C-82 Topical Gel, 1%|active
16063109|NCT02432027|Drug|Daivonex cream|comparator
16063110|NCT02432027|Drug|Diprosis gel|comparator
16063116|NCT02431988|Procedure|Leukapheresis|Patients will undergo leukapheresis prior to pre-conditioning chemotherapy to provide the immune cells required to produce the therapeutic product.
16063117|NCT02431988|Drug|Cyclophosphamide|Patients will receive a standard pre-conditioning regime with cyclophosphamide 60mg/kg/day IV over 1 hour for 2 days (day-7 and day-6).
16063118|NCT02431988|Drug|Fludarabine|Fludarabine 25mg/m2/day IV over 15/30 minutes for 5 days (Day-5 to day-1).
16063119|NCT02431988|Biological|CAR19 T-Cells|"The CAR19 T-cells are to be administered on day 0 at the dose specified by the Cancer Trials Centre (CTC) at the time of registration.
~Three dose cohorts are planned:
~Dose Level 1: 2x105 CAR19 T-cells/kg
~Dose Level 2: 1x106 CAR19 T-cells/kg
~Dose Level 3: 5x106 CAR19 T-cells/kg"
16063120|NCT02431975|Drug|Nevirapine|"Standard medication used to treat and prevent HIV/AIDS, specifically HIV-1. It is generally recommended for use with other antiretroviral medication.
~The initial dose of NVP will be 6 mg per kg per dose orally twice daily until 42 weeks gestational age (2 weeks of age for infants born at term) which is the dosing selected by the NIH International Maternal, Pediatric, Adolescent AIDS Clinical Trials (IMPAACT) Network."
16063121|NCT02431975|Drug|Zidovudine|"An antiretroviral medication used to prevent and treat HIV/AIDS. It is generally recommended for use with other antiretroviral.
~ZDV will be dosed as per standard guideline and routine practices."
16063122|NCT02431975|Drug|Lamivudine|"An antiretroviral medication used to prevent and treat HIV/AIDS. It is effective against both HIV-1 and HIV-2.
~3TC will be dosed as per standard guideline and routine practices."
16063123|NCT02431975|Drug|LPV/r|"Lopinavir is an antiretroviral of the protease inhibitor class. It is used against HIV infections as a fixed-dose combination with another protease inhibitor, ritonavir.
~LPV/r will be dosed as per standard guideline and routine practices."
16063124|NCT02431962|Procedure|Computed Tomography|Low dose chest CT screening annually x 3
16063125|NCT02431962|Behavioral|Active smokers - Smoking cessation arm|Phone based smoking cessation counseling
16063126|NCT02431962|Behavioral|Active smokers - Control arm|Subjects will be provided with general information on available smoking cessation resources
16063127|NCT02431949|Other|Admission to BCPP|There is no intervention associated with this study.
16063128|NCT02431936|Drug|Prazosin|Double blind placebo controlled cross over trial to determine effectiveness of alpha adrenergic blocker in reducing sodium retention during stress.
16063129|NCT02431936|Drug|Placebo|Sugar pill made to look identical to Prazosin intervention.
16063130|NCT02431910|Other|Functional elastic tape|application of KT with tension in the vastos medialis, rectus femoris and vastus lateralis muscles
16063131|NCT02431910|Other|placebo Functional elastic tape|application of KT without tension in the vastos medialis, rectus femoris and vastus lateralis muscles
16063132|NCT02431897|Drug|Conjugated Estrogens Cream|0.625mg/1g cream, 1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
16063133|NCT02431897|Drug|Placebo Cream|1g applied vaginally nightly for 2 weeks then 2x/week for >5 weeks before surgery, then 2x/week for 1 year after surgery.
16063134|NCT02431884|Procedure|collect body fluids/tissues & med history|collect tissues/fluids & history
16063135|NCT02431858|Device|E-Catheter (Pajunk)|
16063136|NCT02431858|Device|Sonolong Catheter (Pajunk)|
16063137|NCT02431845|Drug|SSRIs|usual dose SSRI for obsessive-compulsive disorder, i.e. fluoxetine 40~80 mg dose equivalents
16063138|NCT02431832|Drug|Augmentin tab|
16063139|NCT02431819|Device|contention socks|Patients wear contention socks during 15 days.
16063140|NCT02431806|Drug|Placebo|Matched over-encapsulated placebo capsules administered orally on Day 1 to Week 8.
16063141|NCT02431806|Drug|Levomilnacipran|Over-encapsulated levomilnacipran ER capsules administered orally on Day 1 to Week 8.
16063142|NCT02431806|Drug|Fluoxetine|Over-encapsulated fluoxetine tablets administered orally on Day 1 to Week 8.
16063143|NCT02431793|Behavioral|EMC2 Strategy|Patients of providers randomized to the EMC2 arm will received study related educational tools at the time of their discharge including: (a) health-literacy appropriate MedSheet for hydrocodone-acetaminophen and (b) prescription written with Universal Medication Schedule Take-Wait-Stop language. Additionally, providers related to the patient will be prompted to counseling the patient including: (c) (c-1) ED providers prompted via EHR, (c-2) PCP prompted to counsel on follow-up visit via automated message and (c-3) pharmacists prompted to counsel via request printed on prescription.
16063144|NCT02431793|Behavioral|SMS Text Reminders|In addition to the components of the EMC2 strategy arm, patients will received daily text message reminders about the safe use of opioids for 7 days.
16063145|NCT02431780|Device|ANSeR Software System|ANSeR Software System a stand alone, software medical device for Neonatal seizure decision support tool
16063146|NCT02431767|Biological|PENNVAX®-GP HIV-1 DNA vaccine|Administered by intradermal (ID) injection in Groups 1, 2, and 3; administered by intramuscular (IM) injection in Group 4.
16063147|NCT02431767|Biological|Interleukin-12 (IL-12) DNA adjuvant|Administered by intradermal (ID) injection in Groups 1, 2, and 3; administered by intramuscular (IM) injection in Group 4.
16063148|NCT02431767|Biological|Placebo|Sterile Water for Injection, USP. Administered by intradermal (ID) injection in Groups 1, 2, and 3; administered by intramuscular (IM) injection in Group 4.
16063149|NCT02431754|Drug|Tadalafil|Administered orally
16063150|NCT02431754|Drug|Placebo|Administered orally
16063151|NCT02431754|Drug|Alpha1 Blocker|Administered orally
16063152|NCT02431741|Device|Mepilex Transfer Ag|
16063153|NCT02431728|Dietary Supplement|Melatonin|5 mg capsule p.o. at bedtime daily
16063154|NCT02431728|Dietary Supplement|Matched Placebo|5 mg capsule p.o. at bedtime daily
16063155|NCT02431715|Drug|[18 F]-6-L-fluorodihydroxyphenylalanine (18F-FDOPA)|"All patients will have their weight and baseline vital signs recorded.
~The study subject will have an intravenous catheter inserted and receive a slow bolus intravenous dose of 185 - 370 MBq (5 -10mCi) 18F-FDOPA.
~The patient will rest in a comfortable reclining chair in a warm, private shielded room for 45 to 60 minutes.
~Patients are positioned supine and centered on the scanner bed for an average total scan time (CT and PET) of approximately 30 minutes.
~Images will be interpreted by qualified and experienced physicians. Findings of significance from the PET/CT scan, and any incidental findings of significance from the CT scan, will be included in the single final report that will be issued to referring physicians."
16063156|NCT02431702|Drug|Aripiprazole|Aripiprazole will be administered in accordance with the label or Investigator's discretion
16063157|NCT02431702|Drug|Haloperidol|Haloperidol will be administered in accordance with the label or Investigator's discretion
16063158|NCT02431702|Drug|Olanzapine|Olanzapine will be administered in accordance with the label or Investigator's discretion
16063159|NCT02431702|Drug|Oral Paliperidone ER|Paliperidone Extended Release (ER) tablets 1.5 to 12 milligram (mg) per day will be administered orally.
16063160|NCT02431702|Drug|Perphenazine|Perphenazine will be administered in accordance with the label or Investigator's discretion
16063161|NCT02431702|Drug|Quetiapine|Quetiapine will be administered in accordance with the label or Investigator's discretion
16063162|NCT02431702|Drug|Oral Risperidone|Risperidone tablets 1-6 mg per day will be administered orally.
16063163|NCT02431702|Drug|Paliperidone Palmitate Injection (PP1M)|Participants will receive 5 doses of PP1M. First dose at a starting dose of 234 mg on Day 1 and a second dose of 156 mg on Day 8 and then 78 to 234 mg (in 3 flexible doses), every month up to Day 92.
16063164|NCT02431702|Drug|Paliperidone Palmitate Injection (PP3M)|Paliperidone Palmitate injection (PP3M) will be administered once every 12 weeks intramuscularly. The initial dose will be calculated as 3.5 fold multiple of the final PP1M dose administered on Day 92 (or Day 176). Dose will be increased based on Investigator's discretion.
16063165|NCT02431689|Procedure|IVF/ICSI|controlled ovarian hyperstimulation with various protocols, follow up till stimulated follicles measure from 18-20 mm, then ovum pickup followed by embryo transfer is done.
16063166|NCT02431676|Drug|Metformin|Participants will receive metformin, an oral medication for type 2 diabetes.Participants randomized to the metformin intervention will receive metformin up to 2,000 mg per day.Dosing can be flexible, two or three times per day with meals as tolerated for 12 months.
16063167|NCT02431676|Behavioral|Coach Directed Behavioral Weight Loss|Behavioral-based telephonic coaching with web-based support to promote healthy lifestyle and weight loss in overweight and obese adults.The goal of this intervention is to achieve at least 5% weight loss in the first six months of the intervention and maintain these improvements through month twelve by meeting dietary and exercise goals
16063168|NCT02431676|Behavioral|Self-control weight loss|
16063169|NCT02431663|Drug|Ketamine|Intravenous administration in continuous
16063170|NCT02431650|Drug|OZ439|
16063171|NCT02431650|Drug|Primaquine|
16063172|NCT02431637|Biological|Administration of the malaria inoculum|Each participant in the cohort will be inoculated on Day 0 with ~2,800 viable parasites of Plasmodium falciparum-infected human erythrocytes (BSPC) administered intravenously. The threshold for commencement of treatment will be when PCR quantification of all participants is ≥ 5,000 parasites/mL.
16063173|NCT02431637|Drug|Piperaquine Phosphate 480 mg|When PCR quantification of all participants is ≥ 5,000 parasites/mL, participants will receive a single dose of 480 mg Piperaquine Phosphate
16063174|NCT02431624|Drug|BTDS|
16063175|NCT02431611|Behavioral|Biomarker feedback (phone based smoking cessation counseling)|Feedback on maternal cotinine and likely infant NNAL Phone based behavioral smoking cessation counseling
16063176|NCT02431611|Behavioral|Control condition (phone based smoking cessation counseling)|phone-based behavioral smoking cessation counseling
16063177|NCT02431598|Drug|gadoxetate disodium|
16063178|NCT02431598|Drug|gadoterate dimeglumine|
16063179|NCT02431598|Drug|Saline|
16063180|NCT02431585|Dietary Supplement|gluten|
16063181|NCT02431585|Dietary Supplement|placebo|
16063182|NCT02431572|Other|PBR PET|
16063183|NCT02431572|Biological|Cancer Immunotherapy|Subjects who are to be treated with immunotherapy for glioblastoma or melanoma brain metastases will be eligible for 2 of the 3 arms.
16063184|NCT02431572|Radiation|Radiation and chemotherapy|Subjects with glioblastoma will receive or will have received treatment with chemotherapy and radiation per the standard of care.
16063185|NCT02431559|Drug|Durvalumab|Durvalumab is administered as an IV infusion over 60 ± 5 minutes.
16063186|NCT02431559|Drug|Pegylated Liposomal Doxorubicin|PLD was administered as an IV infusion in accordance with local prescribing information.
16063187|NCT02431559|Drug|Motolimod|Motolimod was administered as an SC injection. Within 30 minutes prior to each dose of motolimod, subjects were administered 650-1000 mg acetaminophen by mouth to help mitigate potential adverse events (AEs) commonly associated with the administration of motolimod (e.g., fever, myalgia). On days with concurrent motolimod and durvalumab dosing, motolimod administration occurred 30-60 minutes after the end of the durvalumab infusion. After completion of Phase 1, a protocol amendment was implemented to remove motolimod dosing from the study.
16063188|NCT02431546|Behavioral|Mobile Health Application|"Health coaching is an innovative, holistic approach oriented towards one's full health and wellbeing. Coaches provide mentoring and support regarding many areas of life that impact one's health with a focus on skill-building. Health coaches do not provide medical advice, treat any medical conditions, provide mental health therapy, or provide individualized assessments of nutrient needs. Health coaches will not conduct medication counseling activities that would alter the prescribed regimen nor provide medication information/advice that would be considered the practice of medicine or pharmacy.
~A Fitbit activity monitor will be used to track daily physical activity and provide real-time feedback to the participant."
16063189|NCT02431533|Dietary Supplement|PX0612|PX0612 is a probiotic contained in a veggie capsule.
16063190|NCT02431533|Dietary Supplement|Di-Calcium Phosphate|Patients in the 'placebo' group will receive the placebo capsules. The main ingredient in the placebo capsule is Di-Calcium Phosphate
16063191|NCT02431520|Procedure|Self-collection|Women allocated to this arm will be asked to obtain a specimen of vaginal/cervical by self-collection for HCII.
16063192|NCT02431520|Procedure|Gynecologist collection|Women allocated to this arm will be asked to attend to medical office to have their Pap smear obtained by a gynecologist
16063193|NCT02431507|Device|Magnap|This is a non-randomized clinical trial.Patients 21-70 years diagnosed with moderate to severe obstructive sleep apnea will have the Magnap Magnetic Apnea Device surgically implanted on the subject's hyoid bone and used in conjunction with an external neck brace and magnet to open airway during sleep in treatment of Obstructive Sleep Apnea. We will monitor for safety, brace compliance and improvement of symptoms of sleep apnea for a total of 13 months.
16063922|NCT02426307|Procedure|SAVR|SAVR: surgical Aortic Valve Replacement
16063194|NCT02431494|Device|Blue light phototherapy|Blue light phototherapy (BLU-U Blue Light Photodynamic Therapy Illuminator manufactured by DUSA Pharmaceutical Inc. Wilmington, MA) At each session, the affected areas of the participant's face will be exposed to a light source using blue light phototherapy machine between 15 to 20 minutes. The duration of each session will be approximately 20 minutes.
16063195|NCT02431494|Device|Microcurrent therapy|Microcurrent therapy (Micro Current Electro-Device w/gloves and carrying case, SKU:DSE-X1008 Classic Spa Collection) The investigators will place one electrode in one of the regional areas of the lymph nodes or affected area (i.e. the forehead) and move the second electrode systematically from the affected area towards the stationary electrode. Once the entire affected area has been covered, the investigators will move the first electrode to another regional area of the lymph nodes or affected area and the process will be repeated. This will continue until all of the affected areas have been treated. The duration of each session will be approximately 45 minutes.
16063196|NCT02431494|Device|Combination of BLP and Microcurrent|Same devices as described above. At each session, participants will receive MCT portion as described in above followed by BLP portion as described above. These visits will last approximately 65 minutes.
16063197|NCT02431481|Drug|LEE011|400 mg
16063198|NCT02431468|Drug|Bryostatin 1|The investigational drug product, bryostatin, is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution. Placebo is a sterile, pyrogen-free, lyophilized powder intended for IV infusion upon reconstitution and dilution.
16063199|NCT02431468|Other|Placebo|The placebo is a sterile, pyrogen-free, lyophilized powder identical in appearance to the active drug, intended for IV infusion upon reconstitution and dilution.
16063200|NCT02431455|Device|Incentive spirometer|Incentive spirometer is provided to the patient, this is the current standard of care, and is the control arm.
16063201|NCT02431455|Device|No incentive spirometer|No incentive spirometer is provided to the patient, this is the study arm.
16063202|NCT02431442|Drug|RM-493|
16063203|NCT02431442|Drug|Placebo|
16063204|NCT02431429|Drug|Miltefosine|
16063205|NCT02431416|Drug|Gonadotropin releasing hormone (GnRH)|Gonadotropin releasing hormone GnRH (Relefact LHRH) iv injection, single dose, 100 micrograms/square meter body surface, maximum dose: 100 microgram.
16063206|NCT02431416|Drug|Sodium Chloride|Sodium chlorid 9 mg/mL will be given as a single iv injection with the same volume as the volume used for the active substance injection.
16063207|NCT02431403|Drug|ESHAP-Imatinib|After selection of the maximum-tolerated dose of the combination ESHAP with imatinib a phase 2 of the study will be performed in order to evaluate the ORR of ESHAP-imatinib.
16063208|NCT02431390|Device|RAPAELⓇ Smart Glove digital treatment system|The RAPAELⓇ Smart Glove digital treatment system is constituted for stroke rehabilitation. For use, stroke patients wear the gloves and play the games or puzzle for rehabilitation of upper limbs. The system provides biofeedback to user.
16063209|NCT02431390|Behavioral|Additional occupational therapy|30 minutes of additional conventional occupational therapy session composed of hand dexteriy training
16063210|NCT02431377|Other|S-26 Gold|A commercial whey protein dominant, first age formula, containing whey protein concentrate with alpha-lactalbumin
16063211|NCT02431364|Drug|Verdinexor|Participants received verdinexor; Dosage form: coated, immediate release Tablet; Route of administration: oral
16063212|NCT02431364|Other|Placebo|Participants received placebo matched to verdinexor; Dosage form: coated, immediate release Tablet; Route of administration: oral
16063213|NCT02431351|Drug|Selinexor|60 mg on Day 1 of each week for a 4 week cycle, given for ≥6 cycles.
16063214|NCT02431338|Procedure|Remote ischemic conditioning|Intermittent arm ischemia through four cycles of alternating 5-minute inflation followed by 5-minute deflation of a blood pressure cuff placed around the upper arm.
16063215|NCT02431325|Drug|Teduglutide|
16063216|NCT02431325|Drug|Placebo|
16063217|NCT02431312|Biological|INO-1800|INO-1800 delivered by EP
16063218|NCT02431312|Biological|INO-9112|INO-9112 delivered by EP
16063219|NCT02431312|Drug|Nucleos(t)ide Analogue Treatment|Continued treatment with nucleos(t)ide analogue
16063220|NCT02431286|Drug|Aprepitant|aprepitant will be administered in preoperative period; intravenous palonosetron and dexamethasone will be administered intraoperatively
16063221|NCT02431286|Drug|Placebo|Placebo will be administered in the preoperative period; intravenous palonosetron and dexamethasone will be administered intraoperatively
16063222|NCT02431286|Drug|Dexamethasone|Dexamethasone and plonosetron will be administered intraoperatively in both groups, durong surgery
16063223|NCT02431273|Drug|TDF IVR|
16063224|NCT02431273|Drug|TDF-FTC IVR|
16063225|NCT02431273|Drug|TDF-FTC-MVC IVR|
16063226|NCT02431260|Drug|INCB054329 Monotherapy|Initial cohort dose of INCB054329 monotherapy at the protocol-specified starting dose in the treatment group A (TGA), with subsequent cohort escalations in the three treatment groups (TGA, TGB, and TGC) based on protocol-specific criteria
16063227|NCT02431247|Drug|Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide FDC|A tablet containing DRV 800 mg, COBI 150 mg, FTC 200 mg and TAF) 10 mg will be administered once daily.
16063228|NCT02431247|Drug|DRV/COBI FDC|A tablet containing DRV 800 mg and COBI 150 mg will be administered once daily.
16063229|NCT02431247|Drug|FTC/TDF FDC|A tablet containing FTC 200 mg and TDF 300 mg will be administered once daily.
16063230|NCT02431247|Drug|D/C/F/TAF FDC - Matching Placebo|Matching placebo of D/C/F/TAF FDC will be administered once daily.
16063231|NCT02431247|Drug|FTC/TDF FDC Matching Placebo|Matching placebo of FTC/TDF FDC will be administered once daily.
16063232|NCT02431247|Drug|DRV/COBI FDC Matching Placebo|Matching placebo of DRV/COBI FDC will be administered once daily.
16063233|NCT02431234|Other|serum RANKL|
16063234|NCT02431221|Drug|Perhexiline|perhexiline maleate, oral, 25mg or 100mg tablets Whenever initiating PHM therapy, subjects will receive a loading regimen of PHM as indicated in in the Heart Metabolics Dose Justification document. Drug levels will be measured first on Day 4 +/- 1 day, with an initial dose adjustment performed on Day 7 +/- 1 day, as needed. The next sampling will occur on Day 21 +/- 1 day for potential dose adjustment, as advised by the DCC, on or about Day 24. Subsequent dosing will be monitored and advised by a Dose Control Center
16063235|NCT02431221|Drug|Placebo|
16063923|NCT02426294|Drug|Pioglitazone|
16063236|NCT02431208|Drug|Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody|Participants will receive intravenous (IV) atezolizumab until loss of clinical benefit, withdrawal, or study end. Cohorts A to C will receive 1200 milligrams (mg) on Day 1 of each 21-day cycle. Cohorts D to F (combination with daratumumab) will receive 840 mg on Days 2 and 16 of Cycle 1 and on Days 1 and 15 of each 28-day cycle thereafter.
16063237|NCT02431208|Drug|Daratumumab|Participants will receive 16 milligrams per kilogram (mg/kg) IV daratumumab until loss of clinical benefit, withdrawal, or study end. Treatment will be per the U.S. Package Insert and given on Days 1, 8, 15, 22 of Cycles 1 and 2; on Days 1 and 15 of Cycles 3 to 6; and on Day 1 of each 28-day cycle thereafter.
16063238|NCT02431208|Drug|Lenalidomide|Lenalidomide will be administered orally (PO) until loss of clinical benefit, withdrawal, or study end. Cohort B1 will receive 10, 15, or 25 mg, ascending-dose lenalidomide, on Days 1-14 of each 21-day cycle. Cohort C will receive 10 mg on Days 1-14 of each 21-day cycle, beginning in Cycle 4. Cohort E (combination with daratumumab) will receive 10, 15, or 25 mg on Days 1-21 of each 28-day cycle. Participants in Cohort E1 will receive ascending-dose lenalidomide, and those in Cohort E2 will receive lenalidomide at the MTD as determined in Cohort E1.
16063239|NCT02431208|Drug|Pomalidomide|Pomalidomide will be administered PO until loss of clinical benefit, withdrawal, or study end. Cohort F (combination with daratumumab) will receive 2 or 4 mg on Days 1-21 of each 28-day cycle. Participants in Cohort F1 will receive ascending-dose pomalidomide, and those in Cohort F2 will receive pomalidomide at the MTD as determined in Cohort F1.
16063240|NCT02431208|Drug|Dexamethasone|Participants will receive either 20mg or 40mg of dexamethasone PO every 7 days from Day 1 of each cycle.
16063241|NCT02431182|Behavioral|Memory Training Workshop|"Presentation of the workshop: Objectives and Methodology
~Explanation of the different types of memory and its implication in normal life
~Strategies for gathering and codification of the information
~Strategies for selection and storage the information
~Strategies for gathering, codification, selection, storage and recuperation of the information. Importance of the context and the meaning of things. Semantic and episodic memory
~Strategies for gathering, codification, selection, storage and recuperation of the information. Individual differences
~Strategies for recuperation according to the individual profile. Improving self-esteem
~Strategies for recuperation Social skills.
~Personal and social skills
~New contexts and opportunities
~Evaluation of the workshop"
16063242|NCT02431156|Other|Assessment of visual capacity|"Visual capacity (VC) is variable comprised by three sub-variables: a) (DVC) Visual capacity for activities requiring distant vision, b) (IVC) Visual capacity for activities requiring intermediate vision, and c) (NVC) Visual capacity for activities requiring near vision.
~VC will be measured in a scale from 1 to 100 as the sum of the DVC, IVC and NVC"
16063243|NCT02431143|Drug|Miltefosine|
16063244|NCT02431130|Other|low-fidelity instructor driven simulation training|
16063245|NCT02431104|Device|532-nm KTP/1064-nm Nd:YAG Dual-Pulse Duration Laser|Cutera enlighten dual wavelength 532nm KTP/1064nm Nd:YAG laser
16063246|NCT02431091|Other|Optical Coherence Tomography|Optical Coherence Tomography provides a non invasive evaluation of the thickness of different layers of the retina
16063247|NCT02431078|Procedure|Routine comprehensive treatment|Radical gastrectomy for gastric cancer and postoperative adjuvant chemotherapy
16063248|NCT02431065|Procedure|Rectus sheath block|"Local anesthetics (Ropivacaine 0.75% 10ml) or normal saline (10ml) will be injected in the rectus sheath via different methods:
~Control group Normal saline 10mL will be injected under ultrasonography guidance into the right, left rectus sheath at the end of the operation before emergence from general anesthesia.
~Ultrasonography group Local anesthetic (Ropivacaine 0.75% 10 mL) will be injected under ultrasonography guidance into the right left rectus sheath at the end of the operation before emergence from general anesthesia.
~Direct injection group Local anesthetic (Ropivacaine 0.75% 10 mL) will be injected under direct visualization into the right, left rectus sheath at the end of the operation before emergence from general anesthesia."
16063249|NCT02431065|Drug|Ropivacaine|"Local anesthetics (Ropivacaine 0.75% 10ml) or normal saline (10ml) will be injected in the rectus sheath via different methods:
~Control group Normal saline 10mL will be injected under ultrasonography guidance into the right, left rectus sheath at the end of the operation before emergence from general anesthesia.
~Ultrasonography group Local anesthetic (Ropivacaine 0.75% 10 mL) will be injected under ultrasonography guidance into the right left rectus sheath at the end of the operation before emergence from general anesthesia.
~Direct injection group Local anesthetic (Ropivacaine 0.75% 10 mL) will be injected under direct visualization into the right, left rectus sheath at the end of the operation before emergence from general anesthesia."
16063250|NCT02431065|Other|Normal saline|"Local anesthetics (Ropivacaine 0.75% 10ml) or normal saline (10ml) will be injected in the rectus sheath via different methods:
~Control group Normal saline 10mL will be injected under ultrasonography guidance into the right, left rectus sheath at the end of the operation before emergence from general anesthesia.
~Ultrasonography group Local anesthetic (Ropivacaine 0.75% 10 mL) will be injected under ultrasonography guidance into the right left rectus sheath at the end of the operation before emergence from general anesthesia.
~Direct injection group Local anesthetic (Ropivacaine 0.75% 10 mL) will be injected under direct visualization into the right, left rectus sheath at the end of the operation before emergence from general anesthesia."
16063251|NCT02431052|Drug|Olumacostat Glasaretil|
16063252|NCT02431052|Other|Vehicle|
16063253|NCT02431039|Device|NEOSORB PLUS|Fascia and subcutaneous tissue repaired by antibacterial suture materials (Chlorhexidine diacetate coated PGLA910)
16063254|NCT02431039|Device|NEOSORB|Fascia and subcutaneous tissue repaired by non-antibacterial suture materials (PGLA910)
16063255|NCT02431026|Device|Cooling pack activated Excel Cryo Cooling Collar|Cooling pack will be activated before insertion into collar. The first cooling pack will be replaced 20 minutes later with a new, activated cooling pack.
16063256|NCT02431013|Drug|Simvastatin|Simvastatin 40 mg on Day 1 & Day 8.
16063257|NCT02431013|Drug|Pravastatin|Pravastatin 20 mg on Day 1 & Day 8.
16063258|NCT02431013|Drug|Cilostazol|Cilostazol 100 mg twice a day for 6 days & on Day 8 with statin.
16063259|NCT02431000|Procedure|Sperm and blood collected for analysis|Sperm Collection and Freezing (Cryopreservation), Blood Collection for analysis
16063306|NCT02430623|Procedure|Irreversible electroporation (IRE)|Irreversible Electroportion For Unresectable Urinary Bladder Neoplasms guide with ultrasound or/and CT.
16063307|NCT02430623|Device|NanoKnife|
16063924|NCT02426294|Drug|Glimepiride|
16063260|NCT02430987|Diagnostic Test|Female sexual function index questionnaire|"Sexual function was assessed by completion of the Female Sexual Function Index (FSFI), a questionnaire validated for Brazilian Portuguese with 19 items measuring female sexual function. Cut-off points of >23 and > 26.5 were adopted to define a diagnosis of Female Sexual Function based on the Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision (DSM -IV- TR) by the American Psychiatric Association, duration criteria > 24 weeks.
~A score of 5 or less on the combination of items comprising the desire domain of the FSFI questionnaire was used to define the diagnosis of Hypoactive Sexual Desire Disorder (HSDD) in postmenopausal women We consider that a score of 6 or more the woman does not present with HSDD."
16063261|NCT02430987|Diagnostic Test|Evaluation of presence of metabolic syndrome|The MetS diagnosis was determined by following the guidelines defined by the Adult Treatment Panel (ATP III) (8): (1) Abdominal circumference (AC) ?88cm; (2) HDL-cholesterol < 50mg/dL; (3) triglycerides > 150mg/dL; (4) arterial blood pressure (SAH) > 130/85mmHg; and (5) fasting glucose > 110mg/dL. The women considered as carrying MetS were those with at least three of the components described.
16063262|NCT02430987|Diagnostic Test|Evaluation of the body mass index|women were stratified into 3 groups by body mass index (BMI): Group 1: BMI of 18.5 to 24.9kg/m2 (Normal BMI Group), Group 2: BMI of 25 to 29.9kg/m2 (Overweight Group); Group 3: BMI of 30kg/m2 to 34.5kg/m2 or higher) (Obese Group
16063263|NCT02430974|Drug|Icotinib|Patients in experimental group will receive oral Icotinib for 4-8months.
16063264|NCT02430948|Other|Color-coded materials|A summary of treatment recommendations for each cancer screening is color-coded to indicate the strength and direction of the recommendation
16063265|NCT02430948|Other|Academic detailing|Educational outreach to address the rationale and data supporting recommendations for and against screening
16063266|NCT02430948|Other|Standard support|Screening recommendations presented in standard format
16063267|NCT02430948|Other|No academic detailing|Physician receives study orientation for not the academic detailing curriculum
16063268|NCT02430935|Behavioral|Cognitive Adaptation Training|Cognitive Adaptation Training (CAT) is a manual-driven standardized approach that uses environmental supports to improve multiple domains of adaptive functioning including adherence to medication, grooming, and activities of daily living in patients with schizophrenia. Interventions for each functional deficit are based on two dimensions 1) level of impairment in executive functions (determined by neurocognitive tests) and 2) whether the overt behavior of the individual is characterized more by apathy (poverty of speech/movement/inability to initiate and follow through on behavioral sequences), disinhibition (distractibility/behavior which is highly cue-driven) or a combination of these styles (based on the Frontal Lobe Personality Scale (FLOPS).
16063269|NCT02430935|Behavioral|Action Based Cognitive Remediation|ABCR is applied in once weekly 2 hour sessions in small groups (6-8 per group). In these group sessions, simulated bridging activities are done immediately following computerized cognitive activation to increase the chance that participants retain the strategies just developed in a real life environment.
16063270|NCT02430922|Device|iVolution nitinol stent|
16063271|NCT02430909|Biological|Bimekizumab|"Pharmaceutical form: Solution for infusion
~Concentration: Vials at 80 mg/ml will be diluted with 0.9% sodium chloride to a final concentration to achieve the correct dose
~Route of administration: iv infustion"
16063272|NCT02430909|Biological|Certolizumab Pegol|"Pharmaceutical form: Prefilled syringes
~Concentration: 200 mg/ml
~Route of administration: Subcutaneous injection"
16063273|NCT02430909|Other|Placebo|"Pharmaceutical form: Solution for infusion
~Concentration: 0.9% saline
~Route of administration: Intravenous infusion"
16063274|NCT02430896|Drug|Methylphenidate (MPH)|Subjects of ADHD group will be taking methylphenidate or atomoxetine for 52 weeks.
16063275|NCT02430896|Drug|Atomoxetine|Subjects of ADHD group will be taking methylphenidate or atomoxetine for 52 weeks.
16063276|NCT02430883|Procedure|Retrograde Intrarenal Surgery|endoscopic treatment of kidney stones with flexible renoscopy
16063277|NCT02430870|Drug|TAK-648|TAK-648 solution
16063278|NCT02430870|Drug|Placebo|TAK-648 placebo-matching solution
16063279|NCT02430857|Other|OMT|Manuel osteopathic treatment of the spine
16063280|NCT02430831|Dietary Supplement|Nidina|
16063281|NCT02430831|Dietary Supplement|Placebo|
16063282|NCT02430818|Drug|ketamine|
16063283|NCT02430818|Drug|morphine|
16063284|NCT02430805|Other|dna extraction and genotyping|blood and urine sample
16063285|NCT02430792|Behavioral|Football|The football training will consist of sessions of 20 minutes of warm-up exercises. Followed by 20 minutes dribbling, passing, shooting exercises. Ends with 20 minutes of 5-7 a-side games.
16063286|NCT02430779|Procedure|rreversible electroporation (IRE)|Irreversible Electroportion For Unresectable Renal Pelvic and Ureteral Neoplasms guide with ultrasound or/and CT.
16063287|NCT02430779|Device|NanoKnife|
16063288|NCT02430766|Procedure|Irreversible electroporation (IRE)|Irreversible Electroportion For Unresectable Lymph Node Metastases guide with ultrasound or/and CT.
16063289|NCT02430766|Device|NanoKnife|
16063290|NCT02430753|Procedure|Irreversible electroporation (IRE)|Irreversible Electroportion For Lung Neoplasms accompanied by Respiratory Function Insufficiency guide with ultrasound or/and CT.
16063291|NCT02430753|Device|NanoKnife|
16063292|NCT02430740|Drug|recFSH|
16063293|NCT02430714|Drug|Lenvatinib|24mg once daily oral dosing to Unresectable thyroid cancer patients
16063294|NCT02430701|Procedure|Irreversible electroporation (IRE)|Irreversible Electroportion For Unresectable Esophageal Neoplasms guide with ultrasound or/and CT.
16063295|NCT02430701|Device|NanoKnife|
16063296|NCT02430688|Procedure|Irreversible electroporation (IRE)|
16063297|NCT02430688|Device|NanoKnife|
16063298|NCT02430675|Procedure|Irreversible electroporation (IRE)|Irreversible Electroportion For Unresectable Rectal Neoplasms guide with ultrasound or/and CT.
16063299|NCT02430675|Device|NanoKnife|
16063300|NCT02430662|Procedure|Irreversible electroporation (IRE)|Irreversible Electroportion For Unresectable Rectal Neoplasms guide with ultrasound or/and CT.
16063301|NCT02430662|Device|NanoKnife|
16063302|NCT02430649|Procedure|Irreversible electroporation (IRE)|
16063303|NCT02430649|Device|NanoKnife|
16063304|NCT02430636|Procedure|Irreversible electroporation (IRE)|Irreversible Electroportion For Unresectable Stomach Neoplasms guide with ultrasound or/and CT.
16063308|NCT02430610|Procedure|Irreversible electroporation (IRE)|Irreversible Electroportion For Unresectable Uterine Cervical Neoplasms guide with ultrasound or/and CT.
16063309|NCT02430610|Device|NanoKnife|
16063310|NCT02430597|Procedure|Irreversible electroporation (IRE)|Irreversible Electroportion For Unresectable Hilus Pulmonis Neoplasms guide with ultrasound or/and CT.
16063311|NCT02430597|Device|NanoKnife|
16063312|NCT02430584|Other|Observational - no intervention|
16063313|NCT02430558|Biological|OD-PHOENIX|dellelularized, freeze-dried, irradiated osteochondral allograft
16063314|NCT02430545|Drug|Glasdegib|Subjects receive a 100mg oral dose of glasdegib under fasted conditions with washout, then single 100mg oral dose of glasdegib under fasted following dosing to steady state with rifampin
16063315|NCT02430545|Drug|Rifampin|Subjects receive rifampin 600 mg oral dose daily [Day -6 to day 4]
16063316|NCT02430532|Drug|dimethyl fumarate|capsule
16063317|NCT02430532|Other|Placebo|matched placebo capsule
16063318|NCT02430519|Procedure|Furcation treatment with PRF|PRF Placed into the furcation after flap elevation and debridement
16063319|NCT02430519|Procedure|Furcation Treatment with Allograft and GTR|Allograft and GTR placed into furcation after flap elevation and debridement
16063320|NCT02430519|Device|allograft and guided tissue regeneration (GTR) membrane (DFDBM and Healiguide)|
16063321|NCT02430519|Device|autologous platelet-rich fibrin|
16063322|NCT02430506|Biological|Placebo|This is the identical buffer solution in which AERAS-402 is formulated.
16063323|NCT02430506|Biological|AERAS-402|Given to 8 participants that were QFT-G(-) at screening and 8 participants that were GFT-G(+) at screening.
16063324|NCT02430480|Drug|Goserelin|10.8mg administered subcutaneously every 12 weeks (2 doses)
16063325|NCT02430480|Drug|Enzalutamide|160mg orally, daily for 24 weeks
16063326|NCT02430480|Device|mpMRI|Multiparametric MRI - One at baseline and after 6 months of treatment
16063327|NCT02430467|Behavioral|Caregiver-guided pain management training (CG-PMT)|Patient-caregiver dyads in the CG-PM arm of the study will receive 3 50-minute sessions via Skype with a masters-level therapist over a 3-week period. The intervention integrates educational information about cancer pain and its management with a behavioral training program to teach patients and caregivers pain coping skills including relaxation, imagery, and activity pacing, and to teach caregivers how to guide and coach the patient in the practice and application of these pain control techniques.
16063328|NCT02430467|Behavioral|Enhanced treatment-as-usual (TAU)|Patient-caregiver dyads in the Enhanced TAU condition will receive the same educational video and booklet on cancer pain and its management that is used as part of the CG-PMT intervention. They will also receive iPads with icons linked to reputable websites that provide educational information on cancer including cancer pain (e.g., ACS, NCI) and will be encouraged to utilize them for information and support. However, they will not meet with a study interventionist nor receive any training in behavioral pain coping skills.
16063329|NCT02430454|Behavioral|Increased cognitive load|simulated conditions to increase cognitive load: encourage first impression, time-limit, distractions
16063330|NCT02430428|Device|Carl Zeiss Meditec VisuMax Femtosecond Laser|VisuMax femtosecond laser sphere-only or spherocylindrical treatment
16063331|NCT02430415|Device|laryngoscope-assisted lightwand intubation|laryngoscope-assisted lightwand intubation
16063332|NCT02430415|Device|traditional lightwand intubation|traditional lightwand intubation
16063333|NCT02430402|Other|Rehabilitation in warm climate|
16063334|NCT02430389|Drug|Remifentanil|Ninety seconds before pinning, an IV bolus of 10 mL of remifentanil (0.7 µg•kg-1 based on ideal body weight) will be administered from the study syringe and an IV bolus of propofol (0.7 mg•kg-1) will be administered
16063335|NCT02430389|Drug|Normal Saline|Ninety seconds before pinning, an IV bolus of 10 mL of normal saline will be administered from the study syringe and an IV bolus of propofol (0.7 mg•kg-1) will be administered
16063336|NCT02430363|Drug|MK - 3475|Administered Intravenously
16063337|NCT02430363|Biological|Suppressor of the PI3K/Akt pathways|Capsules orally with food
16063338|NCT02430350|Drug|Compound Edaravone Injection|
16063339|NCT02430350|Drug|Edaravone Injection|
16063340|NCT02430337|Behavioral|Technology-Assisted SafeCare|A technology-enhanced version of SafeCare
16063341|NCT02430337|Behavioral|SafeCare|SafeCare, an evidence-based home visiting program
16063342|NCT02430324|Other|posttraumatic cerebral infarction|the difference between groups refers to the developing of cerebral infarction after traumatic brain injury
16063343|NCT02430311|Drug|Olaparib|Tablet-150mg, Oral
16063344|NCT02430311|Drug|Paclitaxel|Injection
16063345|NCT02430311|Drug|Olaparib|Tablet-100mg, Oral
16063346|NCT02430298|Drug|Melatonin|Drug: Melatonin 20 mg/ 10 ml melatonin suspension gargle for 2 minutes before radiation 15 minutes and 20 mg melatonin gelatin capsule taken orally after 21:00 hours each night throughout the study
16063347|NCT02430298|Drug|Matched Placebo|Drug: Melatonin 20 mg/ 10 ml placebo suspension gargle for 2 minutes before radiation 15 minutes and 20 mg placebo gelatin capsule taken orally after 21:00 hours each night throughout the study
16063348|NCT02430285|Procedure|Endoscopic Ultrasound|Endoscopic Ultrasound
16063349|NCT02430285|Device|Olympus 180 series echoendoscope|
16063350|NCT02430272|Drug|Glycopyrrolate|Intravenously administered 0.005mg/Kg of glycopyrrolate in intervention group
16063351|NCT02430259|Drug|Weekly INH / RRT given by DOT|weekly oral Rifapentine 15 mg/kg (up to 900mg) plus Isoniazid 15 mg/kg (up to 900mg) for 12 doses
16063352|NCT02430246|Dietary Supplement|Urex Plus|Probiotic
16063353|NCT02430246|Other|Placebo|capsule without active ingredient
16063354|NCT02430246|Dietary Supplement|Probotic capsule containing L. rhamnosus GR-1and L. reuteri RC-14|
16063355|NCT02430233|Drug|micronized progesterone 400 mg (Utrogestan)|participants receive vaginal micronized progesterone (Utrogestan- 200mg×2 PV(per vagina) per day)
16063356|NCT02430207|Procedure|temporary pacing femoral vein|Temporary pacing via femoral or subclavian vein
16063357|NCT02430207|Procedure|temporary pacing subclavian vein|
16063358|NCT02430194|Drug|lonafarnib|antiviral farnesyl transferase inhibitor
16063359|NCT02430194|Drug|Ritonavir|CYP 3A4 inhibitor, lonafarnib booster
16063360|NCT02430194|Drug|PEG IFN-a|immunomodulator
16063361|NCT02430181|Drug|lonafarnib|antiviral farnesyl transferase inhibitor
16063362|NCT02430181|Drug|PEG IFN-a|immunomodulator
16063363|NCT02430181|Drug|Ritonavir|CYP 3A4 inhibitor, lonafarnib booster
16063364|NCT02430168|Procedure|Percutaneous nephrolithotomy|
16063365|NCT02430168|Procedure|Retrograde intrarenal surgery|
16063366|NCT02430155|Device|Bakri balloon|is a 100% silicone construction, dual channel balloon catheter specifically designed and approved by FDA for intrauterine placement in cases of PPH. The Bakri balloon contains no latex, and therefore can be safely used in patients with latex allergies
16063367|NCT02430155|Device|Condom loaded foley's catheter|Under aseptic precautions a sterile rubber catheter was inserted within the condom and tied near the mouth of the condom by a silk thread.
16063368|NCT02430142|Other|Vasoocclusive testing|Forearm vasoocclusive testing with a laser-doppler spectrophotometry system, transpulmonary thermodilution and blood sampling;
16063369|NCT02430129|Procedure|Total knee arthroplasty|Zimmer Persona posterior cruciate retaining total knee arthroplasty (ZImmer, Warsaw, IN)
16063370|NCT02430129|Procedure|Unicompartment knee arthroplasty|Biomet Oxford mobile-bearing unicompartmental knee arthroplasty (Biomet, Warsaw, IN)
16063371|NCT02430129|Device|Persona|Zimmer Persona posterior cruciate retaining total knee arthroplasty (ZImmer, Warsaw, IN)
16063372|NCT02430129|Device|Oxford|Biomet Oxford mobile-bearing unicompartmental knee arthroplasty (Biomet, Warsaw, IN)
16063373|NCT02430116|Procedure|Ischemic postconditioning|In the Treat group, the procedure involved 5 min before opening the ascending aorta, aortic unclamping for 30 s, and cross-clamping for 30 s for three cycles, after which the ascending aorta was completely opened.
16063374|NCT02430103|Drug|Goserelin 3.6 MG|In goserelin group, goserelin 3.6mg will be administered every 28 days by subcutaneous injection starting at least 7-14 days before the first cycle of chemotherapy and continued throughout chemotherapy duration.
16063375|NCT02430090|Drug|Levobupivacaine|this used in intratechal area and for spinal anesthesia in ceserean section
16063376|NCT02430090|Drug|Fentanyl|this used in intratechal area and for spinal anesthesia in ceserean section
16063377|NCT02430090|Drug|Sufentanil|this used in intratechal area and for spinal anesthesia in ceserean section
16063378|NCT02430090|Drug|Levobupivacaine|this used in intratechal area and for spinal anesthesia in ceserean section
16063379|NCT02430090|Drug|Levobupivacaine|this used in intratechal area and for spinal anesthesia in ceserean section
16063380|NCT02430077|Drug|Obeticholic Acid|Capsules of obeticholic acid (OCA) or an identical placebo in the dose of 25 mg/day for a period of 4 months .
16063381|NCT02430077|Drug|Placebo|Identical to Obeticholic Acid - placebo drug
16063382|NCT02430064|Other|Low PAMP diet|
16063383|NCT02430051|Behavioral|Sensory Adapted Dental Environment|The SADE intervention includes adaptations such as dimmed lighting, moving projections on the ceiling (fish, bubbles), exposure to soothing music, and application of a butterfly vest with wings that wrap around the child to provide calming sensations.
16063384|NCT02430012|Behavioral|Quality improvement strategies|Training with guidelines of secondary preventions; determining improvement goals; tools (workflow posters and cards, checklists to inform the use of secondary prevention medications); periodical quality feedback report.
16063385|NCT02429999|Drug|Letrezole plus FSH|letrozole, 10 mg daily from day 3-7 and FSH 75IU/day from day 5 continuously and GnRH antagonist (orgalutran 0.25) is given when the follicle size equal to 14 mm till hCG injection.
16063386|NCT02429999|Drug|Standard protocol for induction of ovulation|0.1 decapeptyl from day 21 in the previous cycle and continuously stimulated by FSH (150-225IU/day) from day 2.
16063387|NCT02429986|Device|Adaptive Servo-Ventilation|Adaptive Servo-Ventilation proceeds by continually measuring either minute ventilation or airflow and calculates a target ventilation to be applied as needed.
16063388|NCT02429973|Drug|Gemcitabine plus rapamycin|Gemcitabine and rapamycin given in combination
16063389|NCT02429960|Device|Analgesia monitor (PhysioDoloris®)|Comparison of three different analgesia monitoring systems (PhysioDoloris®, SPI® and AlgiScan®).
16063390|NCT02429960|Device|Analgesia monitor (SPI®)|Comparison of three different analgesia monitoring systems (PhysioDoloris®, SPI® and AlgiScan®).
16063391|NCT02429960|Device|Analgesia monitor (AlgiScan®)|Comparison of three different analgesia monitoring systems (PhysioDoloris®, SPI® and AlgiScan®).
16063392|NCT02429960|Drug|Remifentanil|Remifentanil will be increased step-by-step from 0.05 mcg/kg/min to 0.2 mcg/kg/min. After ensuring a steady-state period of remifentanil infusion of at least 5 minutes, the standardized painful stimuli will be applied.
16063393|NCT02429934|Biological|abatacept also known as Orencia also known as CTLA4-Ig|125mg injected subcutaneously weekly for 16 weeks
16063394|NCT02429934|Drug|Placebo|
16063395|NCT02429921|Dietary Supplement|high-selenium lentils|lentils grown on naturally selenium-rich soils in the Canadian Prairies
16063396|NCT02429921|Dietary Supplement|Low-Se lentils|lentils grown on selenium-deficient soils in Idaho, USA.
16063397|NCT02429908|Device|TM-Ardis Interbody|The TM Ardis implant is a single device manufactured wholly from Trabecular Metal™ (porous tantalum) material, a highly porous, three-dimensional biomaterial designed for biologic fixation. is indicated for use with autogenous bone graft as an intervertebral body fusion device at one or two contiguous levels in the lumbosacral region (L2- S1) in the treatment of degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).
16063398|NCT02429895|Drug|ABT-122|Injection
16063399|NCT02429882|Drug|Brodalumab 210 mg|210 mg brodalumab will be administered subcutaneously
16063400|NCT02429882|Drug|Placebo|Placebo will be administered subcutaneously
16063401|NCT02429869|Drug|everolimus|
16063402|NCT02429856|Device|SCORPIO™|subjects randomized at surgery to receive 1 of the 2 specified implants
16063403|NCT02429843|Drug|TRC105|Each patient will be dosed with 6, 8, or 10 mg/kg of TRC105 up to a maximum dose of 850 mg for women and 1,000 mg for men based upon overall body weight.
16063404|NCT02429830|Device|LINX device|The LINX device is a permanent implant placed at the area of the lower esophageal sphincter (LES) and is designed to augment a weak LES and minimize or eliminate GERD-related symptoms.
16063405|NCT02429817|Drug|Technetium-99m - Diethylenetriaminepentaacetic acid|99mTc-DTPA solution placed on the nebulizer reservoir
16063406|NCT02429817|Device|Aeroneb Solo|
16063408|NCT02429817|Other|Single photon emission computed tomography|Imaging technique to investigate lung aerosol distribution
16063409|NCT02429817|Other|Spirometry|FEV1, FVC assessment
16063410|NCT02429804|Procedure|Contrast-enhanced Magnetic Resonance Imaging|Undergo contrast-enhanced MRI
16063411|NCT02429804|Drug|Fludeoxyglucose F-18|Given IV
16063412|NCT02429804|Drug|Fluorine F 18 Sodium Fluoride|Given IV
16063413|NCT02429804|Procedure|Magnetic Resonance Imaging|Undergo PET/MRI
16063414|NCT02429804|Procedure|Positron Emission Tomography|Undergo PET/MRI
16063418|NCT02429778|Behavioral|Diaphragmatic Breathing|Deep or diaphragmatic breathing is taught prior to relaxation.
16063419|NCT02429778|Behavioral|Progressive Muscle Relaxation|Tensing and releasing muscle groups in a specified order to help reduce tension and anxiety.
16063420|NCT02429765|Drug|ACL/FOR|
16063421|NCT02429765|Drug|Placebo|
16063422|NCT02429752|Other|Inspiratory muscle training|Subjects that demonstrate unresolved BPD's upon reassessment after PT treatment, will have the option to participate in the second phase of the study. These subjects will be scheduled twice a week to receive IMT using the RT2 device and software program. The IMT protocol uses biofeedback to train at a specific percentage of MIP and SMIP for each inspiratory effort.
16063423|NCT02429739|Behavioral|Working memory Training|"The child will use the computer program at home under parental supervision for 25 sessions, each lasting 30 - 45 minutes and the family has 6 weeks to complete the training. Each session consist 8 different tasks presented by an animated robot. The tasks all require the child to hold information in working memory and to manipulate the information.
~Other name: Cogmed RoboMemo"
16063424|NCT02429726|Drug|rAdp53|Recombinant adenoviral p53 human gene will be administered by intra chest cavity infusion
16063425|NCT02429726|Drug|Cisplatin|Cisplatin will be administered by intra chest cavity infusion
16063426|NCT02429726|Drug|rAdp53 plus cisplatin|Recombinant adenoviral p53 human gene combined with cisplatin will be administered by intra chest cavity infusion
16063427|NCT02429713|Procedure|Short-duration tourniquet|Short-duration tourniquet group:inflate the tourniquet immediately before cement application and deflated after its hardening
16063428|NCT02429713|Procedure|Long-duration tourniquet|Long-duration tourniquet group: inflate the tourniquet immediately before incision and deflated after the hardening of the cement
16063429|NCT02429700|Drug|Paclitaxel|Patients receive paclitaxel 175mg/㎡ IV over 3 hours on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
16063430|NCT02429700|Drug|Carboplatin|and carboplatin AUC 5-6 IV over 1 hour on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
16063431|NCT02429700|Drug|Bleomycin|Bleomycin 30000IU IM per day for 3 days every 3 weeks for 3-4 cycles.
16063432|NCT02429700|Drug|Etoposide|Etoposide 100mg/㎡ IV per day for 5 days every 3 weeks for 3-4 cycles.
16063433|NCT02429700|Drug|Cisplatin|Cisplatin 20mg/㎡ IV per day for 5 days every 3 weeks for 3-4 cycles in the absence of disease progression or unacceptable toxicity.
16063434|NCT02429687|Drug|Paclitaxel|Patients receive paclitaxel 175mg/㎡ IV over 3 hours on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
16063435|NCT02429687|Drug|Carboplatin|and carboplatin AUC 5-6 IV over 1 hour on day 1. Treatment repeats every 21 days for 4-6 courses in the absence of disease progression or unacceptable toxicity.
16063436|NCT02429687|Drug|Bleomycin|Bleomycin 30000IU IM per day for 3 days every 3 weeks for 3-4 cycles.
16063437|NCT02429687|Drug|Etoposide|Etoposide 100mg/㎡ IV per day for 5 days every 3 weeks for 3-4 cycles.
16063438|NCT02429687|Drug|Cisplatin|Cisplatin 20mg/㎡ IV per day for 5 days every 3 weeks for 3-4 cycles in the absence of disease progression or unacceptable toxicity.
16063439|NCT02429674|Behavioral|TranS-C and IPT-A|The goal of IPT-A is to decrease depressive symptoms by focusing on current interpersonal difficulties and helping the adolescent improve his or her relationships and interpersonal interactions. This is accomplished through psychoeducation about the adolescent's depression and its link to interpersonal relationships, review of the adolescent's significant relationships, identification of interpersonal problem areas on which to focus the treatment, development of interpersonal problem solving and communication skills, and role-playing. The sleep disturbances intervention will include several modules selected because they are successful treatments for insomnia, and/or may help promote adherence to some of the recommendations related to sleep.
16063440|NCT02429661|Behavioral|Peer support groups|
16063441|NCT02429648|Procedure|DCC first then PVI|DCC performed prior to PVI
16063442|NCT02429648|Procedure|PVI then DCC after|DCC performed after PVI, if patient remains in Atrial Fibrillation
16063443|NCT02429635|Behavioral|My exercise|"Health Screening I and II Questionnaires on health and lifestyle, physiological test of fitness, physiological health tests and blood profile - compiled in a health profile report. Individual guidance and advice from professional health advisor.
~Team-workshop I and II A 2 hours' workshop lead and facilitated by a trained and professional health advisor. It consists of short talks on exercise and health, and on health behavior change and motivation in addition to work with self-reflection and discussion tasks. Competence, support and advice during 2. workshop.
~Exercise groups Small groups with similar exercise level and ambitions who support each other in their efforts to establish new exercise habits according to their individual exercise plan"
16063444|NCT02429622|Radiation|IMRT simultaneous integrated boost|To achieve a prophylactic dosage and radical dosage once respectively
16063445|NCT02429622|Drug|Paclitaxel|Paclitaxel from 45 to 60 mg/m2 per week concurrent with radiotherapy for 5weeks
16063446|NCT02429622|Drug|Nedaplatin|Nedaplatin 25mg/m2 per week concurrent with radiotherapy for 5weeks
16063447|NCT02429622|Procedure|Esophagectomy|Radical esophagectomy 4-6 weeks after neoadjuvant therapy
16063450|NCT02429583|Drug|Recombivax|Injection of Recombivax HBV vaccine administered IM, at 0, 1, and 6 months after enrollment
16063451|NCT02429570|Drug|Meclofenamate|
16063452|NCT02429557|Other|Abdominal compression|Abdominal compression of 40 mmHg with a commercial inflatable cuff applied during head up tilt
16063453|NCT02429557|Other|Sham abdominal compression|Sham abdominal compression of 5 mmHg with a commercial inflatable cuff applied during head up tilt
16063454|NCT02429557|Drug|Placebo pill|Placebo pill given 1 hour before the second heat up tilt
16063455|NCT02429557|Drug|midodrine|Midodrine single dose 2.5-10mg PO given 1 hour before the second head up tilt
16063456|NCT02429544|Behavioral|Residential Program|Participants attend a 7-day offsite, residential support program. On Day 5 of the program, participant joined by spouse or caregiver.
16063457|NCT02429544|Behavioral|Questionnaires|Questionnaires completed about mood, sleep, fatigue, how participant has been feeling, and their general quality of life at baseline visit, 1 month after baseline, 7 days after residential program ends, and again about 3 months later.
16063458|NCT02429544|Device|Electroencephalogram (EEG)|EEG performed at baseline with simultaneous computer testing consisting of 3 tests to check attention, short-term memory, and levels of emotions. EEG repeated 7 days after the residential program ends, and then again about 3 months later.
16063459|NCT02429544|Other|Saliva Testing|Day after baseline visit, saliva collected for 3 days at different times to measure cortisol levels. Saliva testing repeated 7 days after the residential program ends, and then again about 3 months later.
16063460|NCT02429544|Behavioral|Study Diary plus Actigraph|For seven days after baseline visit, participants complete study diary describing sleeping habits. An actigraph also worn during this time to record physical activity and sleeping habits.
16063461|NCT02429531|Biological|Pneumovax 23 (Sanofi Pasteur MSD)|Intramuscular injection of Pneumovax 23 vaccine (0.5 ml).
16063462|NCT02429531|Biological|Typhim Vi (Sanofi Pasteur MSD)|Intramuscular injection of Typhim Vi vaccine (0.5 ml).
16063463|NCT02429518|Drug|Miltefosine|
16063464|NCT02429505|Drug|Miltefosine|miltefosine: target 2.5 mg/kg/day for 28 days
16063465|NCT02429492|Device|Electrophysiology|EMG recordings conditioned by electrical peripheral nerve stimulation and/or transcranial magnetic stimulation
16063466|NCT02429479|Behavioral|Making Your Wishes Known|Making Your Wishes Known provides tailored education, values clarification exercises, and a sophisticated decision aid that translates an individual's goals and preferences into a specific medical plan that can be implemented by a healthcare team.
16063467|NCT02429479|Behavioral|Standard advance care planning|This is a online simple living will form.
16063468|NCT02429466|Drug|Guadecitabine (SGI-110)|SGI-110 will be given subcutaneously, daily, 30 mg/m2 on days (1-5) followed by cisplatin 100mg/m2 on day 8 every 4 weeks.
16063469|NCT02429453|Drug|Four Factor Prothrombin Complex Concentrate|A purified, non-activated prothrombin complex concentrate containing factors II, VII, IX and X and proteins C & S
16063470|NCT02429453|Biological|Fresh Frozen Plasma|A pooled collection of plasma from donors
16063471|NCT02429440|Biological|peptide vaccine|subcutaneous
16063472|NCT02429440|Drug|Granulocyte Macrophage Colony Stimulating Factor|intradermal
16063473|NCT02429440|Drug|Montanide ISA-51|subcutaneous
16063474|NCT02429427|Drug|Celecoxib|Patients will receive 400mg of Celecoxib once daily for two years or until disease progression (if before the two years limit) or until development of unacceptable toxicities. In addition ER(+) patients will receive endocrine treatment according to local practice.
16063475|NCT02429427|Other|Placebo|Two capsules once daily with food
16063476|NCT02429414|Device|Non-Video Double Lumen Tube (DLT)|Participant receives non-video double lumen tube (DLT) placement before surgery.
16063477|NCT02429414|Procedure|Fiberoptic Bronchoscopy (FOB)|Fiberoptic bronchoscopy (FOB) performed to check placement of non-video DLT.
16063478|NCT02429414|Device|Video Double Lumen Tube (VDLT)|Participant receives video double lumen tube (VDLT) placement before surgery.
16063479|NCT02429401|Behavioral|Non-adapted brief motivational interview|1) provide personalized feedback based on screening and baseline assessment, 2) explore decisional balance (pros and cons) of alcohol use from the patient's perspective, 3) build motivation for change through the assessment and discuss the patient's self-report of lf levels of importance, confidence, and readiness to change drinking, 4) enhance commitment to change by exploring the patient's options for change, and developing a change plan if indicated, 5) provide formal alcohol treatment referrals and community resources.
16063480|NCT02429401|Behavioral|Culturally adapted brief motivational interview|Addresses impact of acculturative stress and drinking norms based on screening results and 1) provide personalized feedback based on screening and baseline assessment, 2) explore decisional balance (pros and cons) of alcohol use from the patient's perspective, 3) build motivation for change through the assessment and discuss the patient's self-report of lf levels of importance, confidence, and readiness to change drinking, 4) enhance commitment to change by exploring the patient's options for change, and developing a change plan if indicated, 5) provide formal alcohol treatment referrals and community resources.
16063481|NCT02429388|Drug|Spironolactone|Administration of spironolactone 25-50mg orally twice daily for two days and subsequently titrated upto 100mg twice daily with daily serum potassium monitoring. Spironolactone will continue until patient is euvolemic and appropriate for discharge. Titration of loop diuretics in this arm will not be escalated.
16063482|NCT02429375|Drug|Mocetinostat Plus Brentuximab Vedotin|All patients will receive a 1-week lead-in with mocetinostat alone (administered days 1, 3, and 5). Patients with palpable peripheral lymph nodes will undergo FNA before and after this 1 week treatment. Cycle 1 will then begin 15 days (+/-3 days) following initiation of the lead-in.
16063483|NCT02429349|Procedure|surgery|Surgical Procedures- Unilateral oophorectomy will be performed by laparoscopy prior to undergoing chemo-radiation treatment as specified above. Subsequent ovarian cortex autotransplant will be performed by laparoscopy after the patients have been declared cured by their physicians.
16063484|NCT02429323|Drug|Sevoflurane|use of 8% sevoflurane in compared to incremental dose increased each few breaths from 1% to 8%
16063485|NCT02429310|Device|Revitive IX|This is a neuromuscular electrical stimulation device
16063486|NCT02429297|Other|HITCM-only|HITCM-only group: patients receive weekly automated calls with feedback to the clinical team.
16063925|NCT02426281|Drug|nab-paclitaxel|nab- paclitaxel 125mg/m2 D1, 8 15 every 4 weeks.
16063487|NCT02429297|Other|HITCM+CP|HITCM + CP group: patients receive weekly automated calls with feedback to the clinical team and their CarePartner receives updates via phone or email.
16063488|NCT02429271|Drug|Ticagrelor|
16063489|NCT02429271|Drug|Clopidogrel|
16063490|NCT02429271|Procedure|Percutaneous Coronary Intervention (PCI)|
16063491|NCT02429271|Procedure|Coronary Angiography|
16063492|NCT02429258|Drug|Farxiga|Farxiga 10mg/day
16063493|NCT02429258|Drug|Placebo|Placebo
16063494|NCT02429258|Drug|Metformin|Metformin background therapy >/= 1500mg/day
16063495|NCT02429258|Drug|Insulin|Insulin >/= 30 units
16063496|NCT02429245|Other|Retrospective study|
16063497|NCT02429232|Drug|Pioglitazone|Pioglitazone 30mg/tablet once daily
16063498|NCT02429232|Drug|Linagliptin|Linagliptin 5mg/tablet once daily
16063499|NCT02429219|Drug|Saline Irrigation with Ethanol|Saline Irrigation with Ethanol (alcohol)
16063500|NCT02429219|Procedure|transurethral resection of the prostate|transurethral electro-resection of the prostate (TURP)
16063501|NCT02429219|Procedure|photoselective vaporisation of the prostate|photoselective laser-vaporisation of the prostate (PVP)
16063502|NCT02429206|Other|SQIN|Each patient will be asked to self-apply both creams (experimental vs positive control) on the right and left sides of their body (sides will be randomly assigned).
16063503|NCT02429206|Other|standard moisturizing cream (Glaxal Base)|
16063504|NCT02429193|Drug|Abiraterone + prednisone|Abiraterone acetate (1000 mg/day p.o.) + prednisone (5 mg b.i.d., p.o.)
16063505|NCT02429193|Drug|Enzalutamide|Enzalutamide (160 mg/day p.o.)
16063506|NCT02429180|Other|Rehabilitation|"ReTrain: an exercise-based functional training programme comprising two phases: (1) weekly supervised sessions; (2) monthly drop-in sessions, plus home-based exercise in each phase.
~Week 1: one-to-one consultations with trainer to introduce programme, assess individual's concerns and capabilities, introduce and negotiate initial goals
~Weeks 2-11: bi-weekly 90 minute group class with group-based activities and one-to-one coaching, based on ongoing goal negotiation review and progression.
~Week 12: one-to-one consultations with trainer to review goals and plan ongoing unsupervised exercise programme
~Weeks 13-24: monthly drop-in sessions for one-to-one consultation, support and progression."
16063507|NCT02429167|Device|Cranial nerve non-invasive neuromodulation via PoNS device|The PoNS is a medical device worn around the neck. The controller contains the pulse generator and a user interface. The mouthpiece, held to the top of the tongue, contains 143 circular gold electrodes that deliver a mild, controlled electric stimulation to the subject. While the subject is receiving stimulation, they will perform increasingly difficult balance, posture, gait, and movement control tasks designed to challenge existing abilities. Each training session takes approximately one hour to complete, and is separated by an interval of 2-2.5 hours.
16063508|NCT02429167|Device|Sham PoNS device|The PoNS is a medical device worn around the neck. The controller contains the pulse generator and a user interface. The mouthpiece, held to the top of the tongue, contains 143 circular gold electrodes that deliver a mild, controlled electric stimulation to the subject. The sham control device is physically identical but uses a modified stimulus waveform parameter set designed to elicit a mild tactile sensation while minimizing the net energy delivered, minimizing any neuromodulatory effect. While the subject is receiving stimulation, they will perform increasingly difficult balance, posture, gait, and movement control tasks designed to challenge existing abilities. Each training session takes approximately one hour to complete, and is separated by an interval of 2-2.5 hours.
16063509|NCT02429154|Other|Normocapnia|Normoventilation in order to have an end-tidal carbon dioxide (ETCO2) of 5.5 kiloPascal (kPa)
16063510|NCT02429154|Other|Mild Hypercapnia|Decrease in minute ventilation in order to increase ETCO2 to 6.5 kPa
16063511|NCT02429141|Procedure|US-guided periarterial techique|The needle will be inserted in the axillary fossa in-plane (cranial to caudal) close to the intersection of the pectoralis and biceps muscles. Two separate injections of local anesthetic will be made deep and superficial to the axillary artery
16063512|NCT02429141|Procedure|US-guided multi-injection technique|The median, ulnar and radial nerves will be identified by ultrasound. Local anesthetic will be injected adjacent to each nerve
16063513|NCT02429128|Other|14 weeks exercise training|
16063514|NCT02429115|Other|Mentoring|Six months of peer-mentoring.
16063515|NCT02429102|Drug|MT-8554|
16063516|NCT02429102|Drug|Placebo|
16063517|NCT02429089|Drug|LEE011|"The first 12 patients will receive cetuximab associated with LEE011 at doses of 400 mg and 600 mg daily to determine the DLTs and safety.
~In the expansion part, besides safety, objective response rate, progression-free survival and overall survival will be calculated with the inclusion of 14 patients."
16063518|NCT02429076|Drug|IV methylphenidate|IV methylphenidate will be administered to induce emergence from general anesthesia.
16063519|NCT02429076|Drug|Placebo|normal saline
16063520|NCT02429076|Drug|Sevoflurane|Inhaled anesthetic
16063521|NCT02429076|Drug|Propofol|IV anesthetic
16063522|NCT02429063|Other|Bright White Light|The light will be administered via a Litebook Elite or Litebook Advantage (Litebook®, Ltd., Medicine Hat, Canada). The Litebook® is a small (6×5×1 in.) and lightweight (8 oz.) box and will be fitted with adherence monitors to record at what time and for what duration the light box is turned on. The Litebook® is designed to be placed on a table approximately 18 inches from the participant's head and within 45° of the midline of the visual field. The BWL Litebook® looks identical to the DRL and utilizes 24 white light-emitting diode (LED) lights and does not emit ultraviolet light.
16063523|NCT02429063|Other|Dim Red Light|The light will be administered via a Litebook Elite or Litebook Advantage (Litebook®, Ltd., Medicine Hat, Canada). The Litebook® is a small (6×5×1 in.) and lightweight (8 oz.) box and will be fitted with adherence monitors to record at what time and for what duration the light box is turned on. The Litebook® is designed to be placed on a table approximately 18 inches from the participant's head and within 45° of the midline of the visual field. The DRL Litebook looks identical to the BWL box and contains red lights rather than white LED lights.
16063524|NCT02429050|Drug|sustained release morphine|Patients will receive morphine SR 10mg two to three times daily or placebo. Hard gelatin capsules of size AA in Swedish orange containing one morphine SR tablet 10 mg per capsule will be produced. Morphine SR has a marketing authorisation for pain and will be used according to current Dutch and international guidelines for treatment of dyspnea.
16063525|NCT02429050|Drug|placebo|Patients in the control group will receive placebo, consisting of microcrystalline cellulose (FMC BioPolymer). Hard gelatin capsules of size AA in Swedish orange containing microcrystalline cellulose will be produced.
16063526|NCT02429037|Drug|rAd-p53|multi-point injections of rAd-p53 into tumor on day 1, 8 and 15 at a dose of 2 × 10^12 viral particles (VP) in a 21-days cycle.
16063527|NCT02429037|Radiation|radiation|radiation therapy will be given at a total dose of 60 Gy by 2.0 Gy/fraction, daily Monday-Friday for 6 weeks.
16063528|NCT02429037|Drug|Cisplatin|Cisplatin 100 mg/m2 IV on days 1 plus paclitaxel 30 mg/m2 IV on day 1, 8 and 15
16063529|NCT02429024|Device|OneTouch Reveal® Mobile APP|Diabetes management application for use on a mobile phone.
16063530|NCT02429024|Device|OneTouch Verio® Flex BGMS|Blood Glucose Monitoring System (BGMS)
16063531|NCT02428998|Dietary Supplement|Korean Red Ginseng|
16063532|NCT02428998|Dietary Supplement|Placebo|
16063534|NCT02428972|Drug|Propofol|Propofol infusion @100-200 mcg/kg/min Fentanyl 1mcg/kg Vecuronium 0.1mg/kg Mannitol 1 gm/kg
16063535|NCT02428972|Drug|Sevoflurane|MAC of Sevoflurane will be maintained between 0.8-1.2 Fentanyl 1mcg/kg Vecuronium 0.1mg/kg Mannitol 1 gm/kg
16063536|NCT02428959|Drug|Amyl Nitrite|Amyl nitrite is the chemical compound with the formula C5H11ONO. It relaxes vascular smooth muscle; decreases venous ratios and arterial blood pressure; reduces left ventricular work; decreases myocardial oxygen consumption. The method of administration is via inhalation with onset of action within of 30 seconds and ends 2-3mins. In a study by Dodds et al., amyl nitrite is used as part of radiologic esophagram test in order to distinguish patients with pseudoachalasia from those with idiopathic achalasia since amyl nitrite has transient effect on the lower esophageal sphincter (LES). The study revealed that the LES pressure in achalasia patient decreases substantially in response to amyl nitrite with the measurable increase in LES diameter of 3 mm to an average of 4.6m. In contrast, amyl nitrite does not relax the LES segment in pseudoachalasia and has no change in LES diameter. Thus, the investigators anticipate amyl nitrite inhalation will be beneficial at the LES during HREM.
16063537|NCT02428946|Drug|Bromocriptine|Investigating the randomized order for timing of bromocriptine administration
16063538|NCT02428933|Drug|Bromocriptine|The investigators will look at the physiological effect of dopamine on BAT activity rather than on the effect of the drug itself
16063539|NCT02428920|Behavioral|Peer Groups|The intervention group arm will attend biweekly or monthly peer group meetings to discuss health successes and challenges.
16063540|NCT02428907|Behavioral|simulation training|teamtraining of endoscopy staff
16063541|NCT02428894|Device|LVAD|
16063542|NCT02428881|Drug|onabotulinumtoxinA|Patients received 100U onabotulinumtoxinA injection into the external urethral sphincter
16063543|NCT02428868|Drug|tranexamic acid (Exacyl®)|1 gram diluted in 20 mL saline solution, in 30 minutes, five minutes before skin incision and a second 1 gram, 3 hours later
16063544|NCT02428868|Drug|intravenous iron (Ferroven®)|2 vials of 10 mL containing each one 100 mg iron, diluted in 100 mL normal saline over 30 minutes before induction of anesthesia and repeated on day two and three.
16063545|NCT02428868|Other|Saline|20 mL saline in 30 minutes, five minutes before skin incision and 20 ml 3 hours later.
16063546|NCT02428855|Drug|Dasatinib|
16063547|NCT02428842|Procedure|Tumor biopsies|Tumor biopsies will be performed before and after treatment.
16063548|NCT02428842|Procedure|Blood sampling|Blood sampling will be performed before and after treatment.
16063549|NCT02428829|Procedure|Attempt walking from 4 hours post operatively, on the day of their surgery.|Intervention group will be seen by a physiotherapist to attempt walking from 4 hours post operatively, on the day of their surgery.
16063550|NCT02428829|Procedure|Control - standard treatment|standard physiotherapy in line with current hospital protocol including first walking approximately 24 hours post operatively.
16063551|NCT02428816|Other|MRI acquisition|MRI acquisitions
16063552|NCT02428816|Behavioral|behavioral evaluations|Evaluations about motor abilities, sleep, cognition and lifestyle
16063553|NCT02428803|Other|Telemedicine|Patients will be administered the KDQOL-SF and the IIRS and will all start in the standard of care arm. During this time period the patients will receive 6 months of visits as per the usual standard of care. At the end of 6 months the KDQOL-SF and IIRS will again be administered. The patient will then transition to the telemedicine arm of the study for the duration of 6 months. During this time, the patient will come to the dialysis unit on a quarterly basis for a standard visit with labs being drawn in-center and for an in-center Kt/V. For the 2 months following the visit ,however, the patient will not be required to come to the dialysis unit. The monthly face to face and labs will be achieved remotely
16063554|NCT02428777|Drug|Tramadol|Women will receive oral tramadol 100 mg 1 hour before the procedure.
16063555|NCT02428777|Drug|Diclofenac|Women will receive oral diclofenac 100 mg 1 hour before the procedure
16063556|NCT02428777|Drug|Placebo|Women will receive an oral placebo 1 hour before the procedure
16063557|NCT02428764|Drug|Nimotuzumab|Nimotuzumab was given 200 mg i.v. injection over 30 min on days 1 and 8
16063558|NCT02428764|Drug|Gemcitabine|Gemcitabine was given 1000 mg/m2 i.v. injection on days1 and 8.
16063559|NCT02428764|Drug|Carboplatin|carboplatin was given dosed to an area under the serum concentration-time curve (AUC) of 5 i.v. on day 1.
16063560|NCT02428764|Procedure|Surgery|Patients' resectability was assessed by a medical team, including thoracic surgeons, medical oncologists, and radiologists.
16063561|NCT02428751|Drug|Pegylated liposomal doxorubicin|30 mg/m2, IV (in the vein) on day 1 of each 21 day cycle
16063562|NCT02428751|Drug|Doxorubicin|50 mg/m2, IV (in the vein) on day 1 of each 21 day cycle
16063563|NCT02428751|Drug|Rituximab|375 mg/m2, IV (in the vein) on day 0 of each 21 day cycle
16063564|NCT02428751|Drug|Cyclophophamide|750 mg/m2, IV (in the vein) on day 1 of each 21 day cycle
16063565|NCT02428751|Drug|Vincristine|1.4 mg/m2 (2mg in maxium), IV (in the vein) on day 1 of each 21 day cycle
16063566|NCT02428751|Drug|Prednisone|100mg/d, PO on day 1-5 of each 21 day cycle
16063567|NCT02428725|Other|blood sample|Biological samples will be done to determine platelet reactivity testing by VASP-index, will be obtained between 6 and 12 hours after receiving ticagrelor
16063569|NCT02428699|Other|Emulsified cod liver oil product|Participants are required to consume the dose (30 mL) within 1 min, followed by up to 300 mL of apple juice which needs to be consumed within 2 min
16063570|NCT02428699|Other|Non-emulsified cod liver oil product|Participants are required to consume the dose (5.8 mL) within 1 min, followed by up to 300 mL of apple juice which needs to be consumed within 2 min
16063571|NCT02428686|Drug|Epoetin beta (NeoRecormon)|Epoetin beta 60 000 IU/week
16063572|NCT02428673|Other|Assisted Standing Treatment Program|
16063573|NCT02428660|Genetic|Pharmacogenetic testing|Genetic testing for 2D6, 2C9, 2C19, 3A4, 3A5 polymorphisms
16063574|NCT02428660|Other|Software-based drug & gene interaction risk analysis|By assessing a patient's medication list along with the frequencies of variant phenotypes in the population, YouScript is able to identify whether a patient might be at risk for an adverse drug event and suggest when testing might be appropriate.
16063575|NCT02428660|Other|MTM|Medication Therapy Management
16063576|NCT02428647|Dietary Supplement|MNP|MNP containing containing 10 mg zinc and 14 other nutrients, including 6 mg iron, 0.56 mg copper, 17 μg selenium, 90 μg iodine, 400 μg RE vitamin A, 5 μg vitamin D, 5 mg vitamin E, 30 mg ascorbic acid, 0.5 mg vitamin B1, 0.5 mg vitamin B2, 6 mg niacin, 0.5 mg vitamin B6, 0.9 μg vitamin B12, and 150 μg folate
16063577|NCT02428647|Dietary Supplement|preventive zinc supplement|7 mg zinc daily as dispersible tablet
16063578|NCT02428647|Dietary Supplement|therapeutic zinc supplement|20 mg zinc per day for 10 days during diarrhea episodes, as dispersible tablet
16063579|NCT02428647|Dietary Supplement|preventive placebo supplement|dispersible daily placebo tablet
16063580|NCT02428647|Dietary Supplement|therapeutic placebo supplement|dispersible placebo tablet for 10 days during diarrhea episodes
16063581|NCT02428647|Dietary Supplement|placebo powder|placebo powder
16063582|NCT02428634|Behavioral|PSIE13|The Program SI! is implemented from 1st to 3rd grade of Elementary. A total of 40 hours of intervention on 1st and 2nd grade and 30 hours on 3rd grade has been established as the minimum intervention per year.
16063583|NCT02428634|Behavioral|PSIE46|The Program SI! is implemented from 4th to 6th grade of Elementary. A total of 30 hours of intervention has been established as the minimum intervention per year.
16063584|NCT02428621|Device|Twicare® appliance|"Early orthodontic treatment with the Twicare®. The Class II treatment is initiated at the age of 7-12 years and continued as long as the Class I is achieved.
~The Twicare® is adjusted in mandibular protraction based on the 2/3 of the condylar test and was were worn during 12 to 14 hours a day (at least 4 hours during the day and all night)."
16063585|NCT02428621|Device|Removable Herbst appliance|"Early orthodontic treatment with the removable Herbst appliance. The Class II treatment is initiated at the age of 7-12 years and continued as long as the Class I is achieved.
~The Herbst appliance is adjusted in mandibular protraction based on the 2/3 of the condylar test and was were worn during 12 to 14 hours a day (at least 4 hours during the day and all night)."
16063586|NCT02428608|Biological|DWP-450 (Botulinum purified neurotoxin, Type A)|Botulinum toxin, Type A
16063587|NCT02428595|Device|Eclipse™ System|"The Eclipse System is a vaginal bowel control (VBC) therapy intended to provide bowel control for women with fecal incontinence. It is comprised of a non-surgical device placed in the vagina (referred to as the Eclipse Insert) and a pressure-regulated pump which is used to inflate and deflate the Insert. A Sizing Kit, for use during the fitting process, and an evaluation Insert (referred to as the Trial Insert) are also part of the Eclipse System."
16063588|NCT02428582|Device|Covered stent (Atrium Type V12)|An endovascular treatment that consists of inserting a covered stent into the stenosed vessels.
16063589|NCT02428582|Device|Bare stent (Brand Cordis Type Palmaz Blue)|An endovascular treatment that consists of inserting a stent into the stenosed vessels.
16063590|NCT02428569|Behavioral|PREPARED Decision Support|The PREPARED DVD presents patient and health care provider testimonials that characterize the pros and cons of different kidney replacement treatment options, including in-center hemodialysis, home hemodialysis, peritoneal dialysis, kidney transplant, and conservative management (i.e., no dialysis or transplant). The PREPARED book reinforces differences between the treatments by showing (in lay language) summaries of scientific evidence on treatment outcomes associated with each kidney replacement option.
16063591|NCT02428556|Other|Facts only|Communicate basic information about breakthrough drugs provided in FDA press release without using Breakthrough label
16063592|NCT02428556|Other|promising language|"Communicate basic information about breakthrough drugs provided in FDA press release, using language commonly used by FDA in describing breakthrough drugs (promising drug)"
16063593|NCT02428556|Other|breakthrough only|Communicate basic information about breakthrough drugs provided in FDA press release using Breakthrough label (similar to information found in FDA press releases)
16063594|NCT02428556|Other|"breakthrough with may warning"|"Adding a tentative disclaimer (similar to that found on the FDA labels of some breakthrough designation drugs): Continued approval for this indication may be contingent upon verification and description of clinical trial benefit in confirmatory trials"
16063595|NCT02428556|Other|"breakthrough with is warning"|"Adding a more definitive disclaimer to minimize inaccurate inference from Breakthrough terminology: Continued approval for this indication is contingent upon verification and description of clinical trial benefit in confirmatory trials."
16063596|NCT02428543|Drug|Ponatinib and Cytarabine|Prospective, non-randomized, open-label, multicenter, dose-escalation phase I-II trial; an adaptive Bayesian logistic regression dose-escalation model incorporating escalation with overdose control will be used (Babb 1998, Tighiouart 2005). Each cohort will consist of 3 evaluable patients
16063597|NCT02428530|Other|Questionnaires|Norbeck Social Support Questionnaire (NSSQ)
16063598|NCT02428517|Procedure|AlloHCT for Young/MSD|Allogeneic hematopoietic cell transplantation with conditioning as follows; Busulfan 3.2 mg/kg (D-7 to D-4) Cyclophosphamide 60 mg/kg (D-3 to D-2) Thymoglobulin 1.5 mg/kg (D-3 to D-1)
16063599|NCT02428517|Procedure|AlloHCT for Young/MUD&FMD|Allogeneic hematopoietic cell transplantation with conditioning as follows; Busulfan 3.2 mg/kg (D-7 to D-4) Fludarabine 30 mg/m2 (D-7 to D-2) Thymoglobulin 3.0 mg/kg (D-3 to D-1)
16063600|NCT02428517|Procedure|AlloHCT for Old/MSD|Allogeneic hematopoietic cell transplantation with conditioning as follows; Busulfan 3.2 mg/kg (D-7 to D-6) Fludarabine 30 mg/m2 (D-7 to D-2) Thymoglobulin 1.5 mg/kg (D-3 to D-1)
16063926|NCT02426281|Drug|gemcitabine|gemcitabine 1000mg/m2 D1, 8 15 every 4 weeks.
16063601|NCT02428517|Procedure|AlloHCT for Old/MUD&FMD|Allogeneic hematopoietic cell transplantation with conditioning as follows; Busulfan 3.2 mg/kg (D-7 to D-6) Fludarabine 30 mg/m2 (D-7 to D-2) Thymoglobulin 3.0 mg/kg (D-3 to D-1)
16063602|NCT02428491|Biological|Hexaxim®|DTaP-IPV-Hep B-PRP-T combined vaccine, 0.5 mL, Intramuscular
16063603|NCT02428478|Drug|Desipramine|200 mg administered 2 hours before normal sleep time
16063604|NCT02428478|Drug|Placebo|Placebo-matching desipramine administered 2 hours before normal sleep time
16063605|NCT02428465|Behavioral|Purposeful Parenting|Purposeful Parenting reinforces responsive interactions that help promote emerging developmental skills. This information is presented over the course of a child's first 12 months, such that core lessons are the same but specific skills are designed to be developmentally appropriate. This repetitiveness, along with the provision of age-appropriate behavioral guidance, will allow parents to successfully engage in responsive interactions with their children.
16063606|NCT02428452|Behavioral|Social ABCs parent-mediated intervention program|The 6-month Social ABCs parent-mediated intervention consists of 12 weeks of parent training and a 12 week implementation phase. 15 training (parent coaching) sessions are provided by a Research Trainer. Each session with the trainer includes a review of the program manual, practice of the techniques in the child's home, and a 15 min video of the parent-child dyad practicing the intervention. Week 9 and 11 are phone consultations. After the active training is complete, the parent enters the 12-week implementation phase, which includes practicing the techniques on their own, with no trainer instruction or contact. The trainer re-visits the parent and child at Week 24 to collect three 15 min videos; 2 generalization videos are also taken with an untrained examiner.
16063607|NCT02428439|Drug|bupropion or lamotrigine|Participants who take the standardized pharmacotherapy (bupropion or lamotrigine) for depression will be observed for 8 weeks. Drugs using in this study are the standard treatment for depression, and are NOT administered as part of this study.
16063608|NCT02428426|Other|endomicroscopy, targeted biopsy and 16s rRNA gene sequencing|
16063609|NCT02428413|Device|ISO-Gard Mask|to scavenge waste anesthetic gases from patients and provide supplemental oxygen
16063610|NCT02428413|Device|Standard oxygen mask|Provide supplemental oxygen
16063611|NCT02428400|Biological|TG1050|TG1050: adenovirus serotype 5 vector based immunotherapeutic product in adenovirus reference material (ARM) buffer
16063612|NCT02428400|Biological|Placebo|Placebo: adenovirus reference material (ARM) buffer
16063613|NCT02428387|Behavioral|My Tools 4 Care|On-line self-administered (My Tools 4 Care) transition toolkit includes interactive activities and resources to help caregivers deal with their transitions
16063614|NCT02428374|Drug|Rosuvastatin plus clopidogrel|Crestor 40 mg daily plus Plavix 600 mg (initial dosis) and 75 mg daily up to 6-mo
16063615|NCT02428374|Drug|Rosuvastatin plus ticagrelor|Crestor 40 mg plus Brilinta 180 mg (initial dosis) and 90 mg bid up to 6-mo
16063616|NCT02428374|Drug|Simvastatin plus clopidogrel|Zocor 40 mg plus Plavix 600 mg (initial dosis) and 75 mg daily up to 6-mo
16063617|NCT02428374|Drug|Simvastatin plus ticagrelor|Zocor 40 mg plus Brilinta 180 mg (initial dosis) and 90 mg bid up to 6-mo
16063618|NCT02428361|Drug|Biologically active human fecal material, OpenBiome|Fecal microbiota transplant
16063619|NCT02428348|Other|Interview about prototype EEG-cap|
16063620|NCT02428322|Dietary Supplement|Placebo|Soft gel capsules will be identical to the vitamin D intervention but contain no vitamin D.
16063621|NCT02428322|Dietary Supplement|VItamin D3|Soft gel capsules will contain 2,000IU vitamin D.
16063622|NCT02428309|Biological|Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells|
16063623|NCT02428296|Drug|Sirolimus|Low dose sirolimus will be given in daily dosing to achieve trough levels of 2-6 ng/ ml.
16063624|NCT02428283|Drug|Ropivacaine|0.25% ropivacaine 2-3 ml was injected around the scalp nerves that are located on the head.
16063625|NCT02428283|Drug|Remifentanil|Remifentanil 1 μg/kg was injected before skin incision.
16063626|NCT02428283|Drug|Sevoflurane|Anesthesia was titrated with sevoflurane, maintaining mean arterial pressure and heart rate within 20% baseline value.
16063627|NCT02428270|Drug|GSK2256098|Small molecule inhibitor of focal adhesion kinase (FAK)
16063628|NCT02428270|Drug|Trametinib|Allosteric inhibitor of mitogen-activated extracellular signal-regulated kinase (MEK)1 and MEK2 activation and kinase activity.
16063629|NCT02428257|Procedure|continuous spinal anesthesia|Spinal puncture performed with a 19-gauge Tuohy needle at the L4-L5 or L3-L4 interspace using a midline approach. 3 cm of a 22-gauge catheter introduced through the needle, directed to the fractured side.
16063630|NCT02428257|Drug|hypobaric bupivacaine|hypobaric bupivacaine was prepared diluting each 1 ml of 0.5% isobaric bupivacaine with 1 ml of sterile water.
16063631|NCT02428257|Drug|isobaric bupivacaine|0.5% isobaric bupivacaine
16063632|NCT02428257|Drug|ephedrine|
16063633|NCT02428244|Behavioral|Motivational Interviewing|Motivational Interviewing coupled with education will be provided to help participants understand the risks associated with smoking and their fracture care. They will be referred to the quitline.
16063634|NCT02428244|Behavioral|Motivational Interviewing + Follow-up|"Motivational Interviewing coupled with education will be provided to help participants understand the risks associated with smoking and their fracture care. They will be referred to the quitline.
~In this intervention, the participants will receive additional motivational interviewing sessions at 2 weeks, 6 weeks, 3 months and 6 months."
16063635|NCT02428231|Drug|dimethyl fumarate|Participants will be dosed twice daily for 12 weeks.
16063636|NCT02428218|Drug|dimethyl fumarate|enteric-coated microtablets
16063637|NCT02428218|Drug|Placebo|enteric-coated microtablets
16063638|NCT02428205|Drug|Propranolol|Participant will receive Propranolol prior to each EIBI session
16063639|NCT02428205|Drug|Placebo|Participant will receive placebo prior to each EIBI session
16063640|NCT02428192|Biological|Ipilimumab|Given IV
16063641|NCT02428192|Other|Laboratory Biomarker Analysis|Correlative studies
16063642|NCT02428192|Biological|Nivolumab|Given IV
16063643|NCT02428179|Procedure|StOP? - Control group|Control group - Surgical procedure without Study Intervention
16063644|NCT02428179|Procedure|StOP? - Intervention group|Intervention group - Surgical procedure with intraoperative briefings, optional interventions: Transparent drape between anesthesia and sterile team, Controlling noise and potential distractors during wound closure, Nutritional support during the operation
16063645|NCT02428153|Other|stretching exercises|static stretching exercise of 5 repetitions, with a duration of 45 seconds to the right gastrocnemius muscle and dynamic stretching exercise of 5 repetitions, with a duration of 45 seconds to the cases' left gastrocnemius muscles
16063646|NCT02428140|Device|Medtronic Reveal LINQ|
16063647|NCT02428140|Device|Sorin Spiderflash-t|
16063648|NCT02428127|Dietary Supplement|Carbohydrate beverage powder|Carbohydrate beverage powder fortified with multiple micronutrients. 20g of study product will be administered orally twice a day
16063649|NCT02428127|Dietary Supplement|Calorie matched beverage powder|Calorie matched beverage powder with 80% protein.20g of study product will be administered orally twice a day
16063650|NCT02428127|Other|Water|lukewarm water
16063651|NCT02428101|Genetic|polymorphism analysis|
16063652|NCT02428088|Drug|Dasotraline|Dasotraline 2 mg once daily
16063653|NCT02428088|Drug|Dasotraline|Dasotraline 4 mg once daily
16063654|NCT02428088|Drug|Placebo Comparator|Placebo once daily
16063655|NCT02428075|Behavioral|FCHV visit|Female Community Health Volunteer will visit selected households 3 times a year for providing health promotion messages and measure the blood pressure
16063656|NCT02428062|Procedure|Hemodynamic target|"The anaesthesiologist is requested to maintain intraoperative mean arterial blood pressure of the patient within 10% of the baseline mean arterial blood pressure (recorded during the preoperative evaluation) of that patient. In order to reach this hemodynamic target the anesthesiologist can choose between one or more of the following four sub-interventions:
~vasoconstrictor agents (either phenylephrine, ephedrine, epinephrine, norepinephrine or dopamine)
~intravenous fluids
~patient's positioning
~reduction of depth of anesthesia"
16063657|NCT02428062|Drug|Phenylephrine|Phenylephrine 0.1-0.2 mg intravenous bolus
16063658|NCT02428062|Drug|Intravenous fluids|A crystalloid fluid bolus is given intravenously (5-10 ml/kg)
16063659|NCT02428062|Procedure|Patient's positioning|The operating table is positioned so that the patient's head lies below the level of the patient's feet (Trendelenburg position) in order to increase venous return
16063660|NCT02428062|Procedure|Reduction of depth of anesthesia|The halogenated anesthetic vapor's inspiratory fraction is decreased in order to reduce the associated peripheral vasodilation
16063661|NCT02428062|Drug|Ephedrine|Ephedrine 5-25 mg intravenous bolus
16063662|NCT02428062|Drug|Epinephrine|Epinephrine 5-10 mcg intravenous bolus
16063663|NCT02428062|Drug|Norepinephrine|Norepinephrine 0.01 - 0.1 mcg/kg/min intravenous continuous infusion
16063664|NCT02428062|Drug|Dopamine|Dopamine 5 - 10 mcg/kg/min intravenous continuous infusion
16063665|NCT02428049|Radiation|Stereotactic or conventional radiotherapy and chemotherapy in curative intent|
16063666|NCT02428036|Biological|TBI-1401(HF10)|Patients will receive intratumoral administrations of TBI-1401(HF10). The dose is 1 mL of 1x10^6 TCID50/mL.
16063667|NCT02428036|Biological|TBI-1401(HF10)|Patients will receive intratumoral administrations of TBI-1401(HF10). The dose is 1 mL of 1x10^7 TCID50/mL.
16063668|NCT02428010|Device|TMVR Implant|Implantation of the Twelve TMVR System
16063669|NCT02427997|Behavioral|Treadmill training with Virtual Reality|"VR is defined in general as a high-end-computer interface that involves real time simulation and interactions through multiple sensorial channels. The VR system to be used requires subjects to negotiate virtual obstacles while walking on a treadmill, in a safe environment. This dual task activity has large cognitive components such as information processing, planning, and attention while allowing for training in a more stimulating and enriching environment that includes both cognitive and motor components."
16063670|NCT02427997|Behavioral|Treadmill training|The participants will walk on the treadmill, their gait speed over-ground will be measured at the beginning of each week of training. Progression will include increasing the duration of each of the walking bouts and increasing walking speed.
16063671|NCT02427984|Other|Metal ions dosage and evaluation of local/systemic reaction|"Dosage of Chromium and Cobalt on several biological matrices deriving from each patients.
~Determination of local/systemic reaction"
16063672|NCT02427984|Other|Noise registration and metal ions determination|"Dosage of Vanadium and Titanium on several biological matrices deriving from each patients.
~Determination of range of noise"
16063673|NCT02427984|Other|Metal ions dosage, evaluation of local/systemic reaction, noise registration|"Dosage of Chromium, Cobalt, Vanadium and Titanium on several biological matrices deriving from each patients.
~Determination of local/systemic reaction"
16063674|NCT02427958|Drug|Leuprorelin|Suspension for injection.
16063675|NCT02427945|Behavioral|Provision of information on safe water|A promoter from Evidence Action will visit the household and provide information on safe water.
16063676|NCT02427945|Behavioral|Provision of information on safe water and child nutrition|A promoter from Evidence Action will visit the household and provide information on safe water, as well as child nutrition (including hygiene on food preparation and storage). Households will be given a poster to hang in their dwellings with basic nutrition information. The poster might be smaller and in black and white, or larger and in color.
16063677|NCT02427932|Drug|Ampicillin|Pregnant participants will receive Ampicillin 2g IV loading dose followed by 1g IV every 4 hrs until delivery for Group B Strep prophylaxis; non-pregnant participants will receive Ampicillin for qualifying diagnosis
16063678|NCT02427932|Drug|Ampicillin and Gentamicin|Pregnant participants will receive Ampicillin 2g IV every 6hrs along with Gentamicin 5mg/kg IV every 24 hrs for chorioamnionitis; non-pregnant participants will receive for qualifying diagnosis
16063679|NCT02427932|Drug|Gentamicin|Prescribed to non-pregnant participants
16063680|NCT02427919|Drug|G-CSF|Comparison of the effect of G-CSF use
16063681|NCT02427893|Drug|Cobimetinib|A potent and highly selective inhibitor of MEK1 and MEK2, central components of the RAS/RAF pathway.
16063682|NCT02427893|Drug|Vemurafenib|A low molecular weight, orally available inhibitor of the activated form of the BRAF serine-threonine kinase enzyme, which is commonly found in melanoma
16063683|NCT02427880|Drug|Acetazolamide and Hydrochlorothiazide Followed by Furosemide|
16063684|NCT02427880|Drug|Furosemide and Hydrochlorothiazide Followed by Furosemide|
16063685|NCT02427867|Other|Remote ischemic preconditioning|
16063686|NCT02427867|Other|no ischemic preconditioning|
16063687|NCT02427854|Behavioral|Education by animated training video|Training performed by watching an animated educational video.
16063688|NCT02427854|Procedure|Interactive hands-on bedside training|Training performed as a traditional bedside training supported by a trainer in person.
16063689|NCT02427841|Drug|Fluorouracil|Given IV
16063690|NCT02427841|Drug|Gemcitabine|Given IV
16063691|NCT02427841|Radiation|Image Guided Radiation Therapy|Undergo IG-IMRT
16063692|NCT02427841|Radiation|Intensity-Modulated Radiation Therapy|Undergo IG-IMRT
16063693|NCT02427841|Other|Laboratory Biomarker Analysis|Correlative studies
16063694|NCT02427841|Drug|Nab-paclitaxel|Given IV
16063695|NCT02427841|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16063696|NCT02427828|Device|Visensia Respiration Rate Estimation Service (VRES)|Medical device product to provide respiration rate from PPG signal
16063697|NCT02427802|Drug|Gentamicin collagen sponge|Up to 4 topical Gentamicin Collagen Sponges each containing 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)
16063698|NCT02427802|Other|Placebo|Matching collagen sponge
16063699|NCT02427789|Other|Physical Exercise|physical exercise
16063700|NCT02427776|Biological|Autologous CD4+T cells stimulated and expanded ex vivo by a MOG peptide modified by the introduction of a thioreductase motif into the flanking residues of the T cell epitope|1 administration comprising 5 - 50 millions of cells
16063701|NCT02427763|Device|hours of use (Essix)|the patient will use de thermoplastic device during the night or during all day
16063702|NCT02427763|Other|collect saliva|the patient spit during 30 seconds in a small bottle
16063703|NCT02427763|Other|collect biofilm|a sterile swab is rubbed at the buccal surface of the upper teeth
16063704|NCT02427763|Other|collect epithelium|a sterile cytobrush is rubbed at the buccal surface of gingiva at the upper arch
16063705|NCT02427750|Biological|Aggripal®|TIV
16063706|NCT02427737|Behavioral|Comfort Talk® Training|Personnel of MRI units is trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This entails 16 hrs classroom work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training.
16063707|NCT02427724|Drug|lidocaine 2.5%/prilocaine 2.5% topical anesthetic|
16063708|NCT02427724|Drug|lidocaine 7%/tetracaine 7% topical anesthetic|
16063709|NCT02427724|Drug|placebo vehicle|
16063710|NCT02427724|Device|Q-switched 532nm Laser|
16063711|NCT02427711|Device|Bipolar sealer|Prospective trial with Aquamantys for surgical skin and capsula incision w a retrospective control group using a conventional scalpel skin and capsula incision.
16063712|NCT02427698|Procedure|cyrolipolysis (CoolSculpting device)|Treatment will be a cold exposure for up to 120 minutes using the CoolSculpting device with a commercially available treatment setting.
16063713|NCT02427698|Procedure|subcision|The skin will be punctured using a subcision needle to cut the septa responsible for the skin depression after cryolipolysis.
16063714|NCT02427685|Device|Pulse Co-Ox|Comparison of pulse co-oximeter to blood gas analyzer.
16063715|NCT02427672|Device|Transcranial direct current stimulation|
16063716|NCT02427672|Device|Sham transcranial direct current stimulation|
16063717|NCT02427659|Behavioral|Virtual Reality Distraction|The subjects will receive a 20-minute Virtual Reality Distraction (VRD) during their wound care procedure. The nurse will be doing their wound care.
16063718|NCT02427659|Behavioral|Audio (sound of nature)|"The subjects will listen to an audio recording called Sounds of Nature during their wound care."
16063719|NCT02427659|Behavioral|Control standard nurse wound care|The subjects will receive their standard care during wound care. The nurse will be doing the wound care.
16063720|NCT02427646|Drug|BoNT-A|A serotype of botulinum toxins that has specificity for cleavage of SYNAPTOSOMAL-ASSOCIATED PROTEIN 25 (SNAP-25). BoNT-A's pharmacological action is to inhibit the release of acetylcholine from the neuromuscular junction. BoNT-A peripherally applied using optimal parameters by intramuscular injections to treat tremor in the most bothersome upper extremity every 16 weeks over 96 weeks. The study will be extended for those participants who benefited and will receive treatment every 12 weeks over 96 weeks. BoNT-A dose will range from 50-300 U per arm.
16063721|NCT02427633|Other|Educational Intervention UKRC 1997|Educational poster intervention indicating the modified UKRC 1997 recovery position
16063722|NCT02427633|Other|Educational Intervention UKRC 2010|Educational poster intervention indicating the modified UKRC 2010 recovery position
16063723|NCT02427620|Drug|Cyclophosphamide|Given IV
16063724|NCT02427620|Drug|Cytarabine|Given IV
16063725|NCT02427620|Drug|Dexamethasone|Given PO or IV
16063726|NCT02427620|Drug|Doxorubicin|Given IV
16063727|NCT02427620|Drug|Doxorubicin Hydrochloride|Given IV
16063728|NCT02427620|Drug|Ibrutinib|Given PO
16063729|NCT02427620|Other|Laboratory Biomarker Analysis|Correlative studies
16063730|NCT02427620|Drug|Methotrexate|Given IV
16063731|NCT02427620|Biological|Rituximab|Given IV
16063732|NCT02427620|Drug|Vincristine|Given IV
16063733|NCT02427620|Drug|Vincristine Sulfate|Given IV
16063734|NCT02427607|Drug|Perampanel|Perampanel 2 mg tablets. Doses of perampanel can be adjusted based on clinical judgment. A minimum perampanel dose of 2 mg per day is required to continue in the study. The maximum daily dose of perampanel permitted will be 12 mg per day.
16063735|NCT02427594|Drug|Sodium bicarbonate|Drug/dietary supplement is used in a crossover design to lower the nonvolatile acid load of the diet compared to the control period.
16063736|NCT02427594|Other|Controlled diet|Diet without sodium bicarbonate supplementation
16063737|NCT02427581|Biological|Personalized synthetic long peptide vaccine (Poly ICLC)|
16063738|NCT02427581|Drug|Poly ICLC|
16063739|NCT02427568|Drug|MDMA (125 mg)|Two sessions of MDMA (with therapy) lasting six to eight hours, scheduled two to four weeks apart.
16063740|NCT02427568|Drug|Placebo|Two sessions of placebo (with therapy) lasting six to eight hours, scheduled two to four weeks apart.
16063741|NCT02427568|Behavioral|Therapy|Non-directive therapy
16063742|NCT02427555|Other|Barley kernel bread|3 days intervention with barley kernel bread
16063743|NCT02427555|Other|white wheat bread|3 days intervention with white wheat bread
16064013|NCT02425644|Drug|ponesimod|film-coated tablet with 20 mg ponesimod, administered orally once daily in the morning
16063744|NCT02427542|Other|CBT for Depersonalization/Derealization|In addition to treatment as usual, six sessions of Cognitive Behavioural Therapy for Depersonalization/Derealisation covering psychoeducation, formulation, coping strategies.
16063745|NCT02427542|Other|Treatment as usual|Treatment as usual - in most cases case management/care coordination and may include medication
16063746|NCT02427529|Drug|Human Chorionic Gonadotropin|The addition of hormone to a daily low calorie diet to potentially aid in selective fat loss, or muscle-sparing.
16063747|NCT02427529|Drug|Placebo|
16063748|NCT02427529|Other|Low calorie diet|
16063749|NCT02427503|Procedure|Asthma with NP and require surgery|To evaluate the effect on asthma of functional endoscopic sinus surgery of bilateral sinonasal polyposis in patients diagnosed with persistent asthma and grade II or III sinonasal polyposis.
16063752|NCT02427477|Device|senofilcon A|Subjects will wear the contact lenses in both eyes for seven days
16063753|NCT02427477|Device|delefilcon A|Subjects will wear the contact lenses in both eyes for seven days
16063754|NCT02427464|Biological|VM202|gene therapy
16063755|NCT02427464|Other|placebo|
16063756|NCT02427451|Drug|Bcl-2 Inhibitor GDC-0199|Given PO
16063757|NCT02427451|Biological|Obinutuzumab|Given IV
16063758|NCT02427451|Drug|Ibrutinib|Given PO
16063759|NCT02427451|Other|Pharmacological Study|Correlative studies
16063760|NCT02427451|Other|Laboratory Biomarker Analysis|Correlative studies
16063761|NCT02427451|Other|Quality-of-Life Assessment|Ancillary studies
16063762|NCT02427438|Other|Video|A video with moving demonstration and verbal instruction of the exercise to strengthen low back
16063763|NCT02427438|Other|Handout|A handout with a two dimensional picture and written instruction of the exercise to strengthen low back
16063764|NCT02427425|Device|TENS|
16063765|NCT02427412|Drug|Tranexamic Acid|An anti-fibrinolytic drug injected into the knee joint at the end of surgery, 3 g diluted in 30 ml saline water.
16063766|NCT02427412|Drug|Saline water|30 ml of Saline water injected into the knee capsula at the end of surgery.
16063767|NCT02427412|Drug|Tranexamic Acid|An anti-fibrinolytic drug injected intravenous at the beginning of surgery for BOTH groups.
16063768|NCT02427399|Other|Letter and informational sheet|The patients in this group will be mailed a letter at time 0. The letter will inform the patient that she is overdue for a Pap and will also contain an informational sheet about cervical cancer and Pap tests.
16063769|NCT02427399|Other|Email|The same text shared in the letter will be sent as an email to the patients in this intervention group, again at time 0, 1, and 2 months, as necessary for nonresponders.
16063770|NCT02427399|Other|Phone|The patient will be telephoned and informed that they are due for a Pap, and given the opportunity to schedule an appointment over the phone immediately. Patients will be contacted at time 0, 1, and 2 months as necessary for nonresponders.
16063771|NCT02427399|Other|Multimodal|The patient will be sent a letter/informational sheet at time 0. If she does not respond within one month, she will be sent an email. If she does not respond by 2 months after the start of the intervention period, she will be called.
16063772|NCT02427386|Drug|dynamized estrogen|The dosage of the homeopathic medicine or placebo will be of 3 drops, 2 times a day throughout the period of study, and can be reduced in case of finding of homeopathic aggravation of symptoms. 30 ml bottles will be sufficient for the proposed dosage every 8 weeks of treatment (bimensal period).
16063773|NCT02427386|Drug|placebo|The dosage of the placebo (alcohol solution) will be of 3 drops, 2 times a day throughout the period of study.
16063774|NCT02427373|Dietary Supplement|fish oil ethyl ester|
16063775|NCT02427373|Dietary Supplement|fish oil triglyceride|
16063776|NCT02427373|Dietary Supplement|krill oil|
16063777|NCT02427347|Other|Acupuncture|Acupuncture needles of 0.3mm in diameter and 100mm in length are inserted into gallbladder-meridian(GB)26 about 25-65mm deep by an angle of 15°, following the path of Dai Meridian (towards medial and downside) . The other acupoints are inserted with needles of 0.25-0.3mm in diameter and 25-40mm in length approximately 10-30mm deep, with an angle of 90°. Electro-acupuncture is applied to both sides of GB26 and stomach-meridian(ST)25: cathode is connected to GB26; anode to ST25. Dense-disperse wave pattern and a wave frequency of 2/100 Hertz is chosen. The intensity of the electro-acupuncture is adjusted on average 4-8 milliampere. The needles are subsequently retained for 20min. The results of the study are based on 8 weeks, each week consisting of 3 sessions.
16063778|NCT02427347|Other|Healthy education|Healthy knowledge lectures and issuing brochures are given. Education of patients for conditioning and changing bad habits, diet, quit smoking, limit alcohol consumption, salt restriction, appropriate increase in physical activity.
16063779|NCT02427334|Drug|Dienogest|women will receive oral dienogest 2mg for 14 days starting from the 15th day of menstruation
16063780|NCT02427334|Drug|Fluoxetine|women will receive oral fluoxetine 20mg for 14 days starting from the 15th day of menstruation
16063781|NCT02427334|Drug|Placebo|women will receive oral placebo for 14 days starting from the 15th day of menstruation
16063782|NCT02427321|Device|Video recording of flexible cystoscopic examination|The video feed from the flexible cystoscopic examination will be recorded for all participants in the study. Proof-of-concept device will record high-definition video in a lossless format to a computer hard-drive from any existing cystoscopy equipment
16063783|NCT02427308|Drug|Miltefosine|target dose = 2.5 mg/kg/day for 28 days
16063817|NCT02427009|Other|Prone position for 1 hour after blood patch|After performing a blood patch, the patient will be placed in a prone position for 1 hour. This applies to all blood patches required during her hospitalization.
16065127|NCT02418000|Drug|E6201|Single Group Assignment
16063784|NCT02427295|Drug|Sandostatin (Octreotide Acetate)|"For the patients outlined above (refer to 2), subjects who are not able to be treated by surgery alone:
~Dose: Sandostatin LAR® 20mg per 4 weeks for 3 months -> If serum IFG-1 levels fails to normalize, the dose of LAR will be increased to 30 mg.
~Frequency: every 4 weeks.
~Route of administration: IM injection."
16063785|NCT02427282|Device|miniscrew-supported Frog molar distalizing appliance|miniscrew 10mm length and 1.7mm diameter FORESTADENT company
16063786|NCT02427282|Device|Standard Frog molar distalizing appliance|Nance buttons attached to first premolars band
16063787|NCT02427269|Other|Specimen Collection|"1 10mL red tube and 1 8.5mL yellow tube for serum, plasma, and buffy collection
~Up to 10 research-specific biopsies obtained from the esophagus during the routine care EGD.
~Four biopsies will be taken from the midpoint of the current BE (or midpoint of previous BE if the patient has already received ablation for previous BE),
~Two biopsies from normal squamous epithelium, and
~One biopsy from each area of esophageal nodularity seen during the procedure
~Pathology slides from routine care biopsies taken during the enrollment procedure, as well as retrospective pathology slides from routine care biopsies taken prior to enrollment on the study.
~Up to 4 cytology brushes during the procedure."
16063788|NCT02427256|Device|Device: Topcon Specular Microscope SP-1P|Device: Topcon Specular Microscope SP-1P
16063789|NCT02427243|Drug|Crenezumab|
16063790|NCT02427243|Drug|Crenezumab|
16063791|NCT02427230|Behavioral|Pelvic floor muscle training|"The intervention in group 1 consists of three private lessons in PFMT conducted by a physiotherapist every 4th week.
~At each consultation the physiotherapist will use manual palpation of the pelvic floor muscles and Electromyography Biofeedback (EMG). Patients will be instructed to carry out three series of approximately 10 near-maximal pelvic floor muscle contractions held for approximately 6-8 seconds daily during 12 weeks."
16063792|NCT02427230|Behavioral|Pelvic floor muscle training|"The intervention in group 2 consist of three private lessons in PFMT and intravaginal NMES conducted by a physiotherapist every 4th week.
~At each consultation the physiotherapist will use manual palpation of the pelvic floor muscles and Electromyography Biofeedback (EMG). Patients will be instructed to carry out three series of approximately 10 near-maximal pelvic floor muscle contractions held for approximately 6-8 seconds daily during 12 weeks.
~Additionally, patients will be instructed on how to use intravaginal NMES and each patient receives a vaginal electrical stimulator (CefarPeristim Pro). The NMES settings consist of two different frequencies, 40 Hz and 10 Hz, and patients are instructed to use both settings daily for maximum 30 minutes during 12 weeks."
16063793|NCT02427230|Drug|vaginal electrical stimulator (CefarPeristim Pro)|electrical stimulation
16063794|NCT02427217|Biological|FCH|FCH is a heat-treated, lyophilized fibrinogen (coagulation factor I) powder made from pooled human plasma. FCH is administered as an IV infusion.
16063795|NCT02427191|Other|AmnioFix® Injectable|1 mL injection of 40 mg Micronized dehydrated human amnion/chorion membrane (dHACM)
16063796|NCT02427191|Drug|Saline Injection|Injection of 1mL 0.9% Sodium Chloride Injection, USP
16063797|NCT02427178|Biological|Hematopoietic Allogeneic Stem Cells|HLA 10/10 matched allogeneic bone marrow cells will be infused into recipient (patient).
16063798|NCT02427165|Drug|RPL554|A dual PDE3 and PDE4 inhibitor
16063799|NCT02427165|Drug|Salbutamol|a beta-2 receptor agonist
16063800|NCT02427165|Drug|Placebo|RPL554 placebo containing no active ingredients
16063801|NCT02427139|Device|ANSiStim|ANSiStim allows continuous point stimulation over a period of several days while offering the patient a high degree of comfort and mobility at the same time. Use of the ANSiSTIM therapy provides overwhelming advantage over drug therapy minimizing possible side-effects caused by pain medications (i.e. opioid) such as, for example, impaired reactions. In most cases, the patient continues to lead its life as normal, without side effects or any loss of quality of life.
16063802|NCT02427126|Drug|Apixaban|Apixaban is an oral anticoagulant currently approved for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation, for the treatment of deep vein thrombosis and pulmonary embolism, and for the prophylaxis of systemic embolism after orthopedic surgery
16063803|NCT02427126|Drug|Aspirin|Acetylic Salicylic Acid 100mg o.d.; 12 Months
16063804|NCT02427113|Other|Sound Oasis Vibrating Chair|Sound oasis vibroacoustic chair will be used as treatment for managing TMD related pain
16063805|NCT02427113|Other|Self-Select Music|The self-select music of the participants will be applied for managing the painful symptoms of TMD
16063806|NCT02427100|Behavioral|Diet/Physical Activity|Diet/Physical Activity Intervention
16063807|NCT02427087|Behavioral|Continuous Aerobic Training twice|Supervised aerobic exercise program of 60 min/2 days/week at 60-85% of heart rate reserve for 24 weeks and healthy diet
16063808|NCT02427087|Behavioral|Healthy Diet|Diet group (21) Recommendation for healthy diet.
16063809|NCT02427074|Procedure|Balloon Compression Rhizotomy|The balloon compression rhizotomy is performed in a percutaneous fashion where a Fogarty catheter is positioned in the gasserian ganglion and inflated with 0,7 milliliters of radiopaque dye during 120 seconds.
16063810|NCT02427074|Procedure|Radiofrequency Thermal Coagulation Rhizotomy|The gasserian ganglion is submitted to a controlled thermal coagulation with a electrode with 80 Celsius degrees of temperature during 60 seconds on the specific division.
16063811|NCT02427061|Behavioral|Intervention Program (Manhood 2.0)|
16063812|NCT02427061|Behavioral|Control Program (Job Skills Training)|
16063813|NCT02427048|Behavioral|Feedback with Peer Comparison|Email detailing adherence to CAP and SS CPG for every month since start of study. Physicians will be provided individualized feedback and given patient identifiers for each patient that received non-adherent care.
16063814|NCT02427035|Biological|CSL112|CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.
16063815|NCT02427035|Other|Placebo|0.9% weight/volume sodium chloride solution (ie, normal saline)
16063816|NCT02427022|Other|CTI|CTI is an empirically supported, time-limited case management model designed to prevent homelessness and other adverse outcomes in people with mental illness following discharge from hospitals, shelters, prisons and other institutions. CTI was originally developed and tested by researchers and clinicians at Columbia University and New York State Psychiatric Institute with significant support from the National Institute of Mental Health and the New York State Office of Mental Health.
16064668|NCT02420886|Other|Adding LIF, HB-EGF and GM-CSF to Lifeglobal human IVF culture media|
16063818|NCT02427009|Procedure|Blood patch|And indicated in inclusion criteria, patients in this protocol will have at least 1 blood patch. The amount of blood to be injected into the peridural space is fixed at 20 ml, but can be less in case of pain.
16063819|NCT02426996|Procedure|Scan of shoulder|A scan (no injection) of the concerned shoulder will be performed at 3 months post-surgery. Cuts in three planes of space, including all of the glenoid. 3D reconstructions.
16063820|NCT02426983|Device|Direct Current Stimulation|"Comparison between active Direct Current Stimulation (2 mA, 20 minutes) and Sham stimulation (the device is set up, but only turned on for 30 seconds).
~Conductive saline-soaked rubber electrodes super-imposed on sponge plates will be placed on the scalp overlying the left auditory cortex (anodal electrode) and on the contralateral forehead above the orbit (reference/cathode). Stimulation will be applied using a battery-driven constant-current regulator (Oasis Pro, Edmonton). In active tDCS sessions, the DC current will be initially increased in a ramp-like fashion over 10 s until reaching 2 mA and will be similarly decreased at the end of stimulation. In active tDCS, stimulation will be maintained for a total of 20 minutes. This will occur in two separate sessions, occurring within weeks. For 'sham' stimulation, the device will only be turned on for 30 seconds. This will occur in two separate sessions, occurring within weeks."
16063821|NCT02426983|Drug|Dextromethorphan|Comparison between Dextromethorphan and a no-sugar placebo. Dextromethorphan (DMO), a non-competitive NMDA antagonist, will be delivered in the form of generic Life Brand Clear Cough Syrup DM (Trillium Healthcare Products Inc, Brockville, ON), which has high dose of DMO (15 mg/5 ml) with no other major additives. Each subject will receive a dose of 50 ml DM with no-sugar cranberry juice (100 ml) to drink from a mug, while wearing a nose plug. This same dose will be delivered in two separate sessions, occurring within weeks. Each subject will receive a dose of a placebo (150 ml of no-sugar cranberry juice) to drink from a mug, while wearing a nose plug. This same dose will be delivered in two separate sessions, occurring within weeks.
16063822|NCT02426957|Behavioral|motivational enhancement therapy|The intervention consists of the following components: establishing rapport, assessing motivation for change, enhancing motivation for change, envisioning the future, establishing goals, and completing goals, strategies, and change plan worksheets.
16063823|NCT02426944|Drug|NOAC|Medical arm, patients will be treated by NOAC.
16063824|NCT02426944|Device|Left atrial appendage closure|The patients will be treated by interventional closure of the left atrial appendage.
16063825|NCT02426931|Device|the tip-flexible ureterorenoscope|Ureteroscopy will be conducted using the tip-flexible semi-rigid ureterorenoscope to treat renal calculi. Holmium laser and basket can be used to perform the technique.
16063826|NCT02426931|Device|the classic flexible ureteroscope|Ureteroscopy will be conducted using the classic flexible ureteroscope (Flex x2 STORZ, Germany) to treat renal calculi. Holmium laser and basket can be used to perform the technique.
16063827|NCT02426918|Drug|Debio 1450 IV|Intravenous (IV) form of Debio 1450 will be supplied in vials containing 50 mg of active pharmaceutical ingredient (API). Intravenous infusions of Debio 1450 (160 mg and 80 mg) will be administered over a 2-hour period BID every 12 hours within a 2-hour window (12 ± 2 hours).
16063828|NCT02426918|Drug|Debio 1450 Oral|Oral forms of Debio 1450 will be provided as white, opaque, hard gelatin capsules containing 50 mg drug substance (equivalent to 40 mg of Debio 1450).
16063829|NCT02426918|Drug|Linezolid|Linezolid for oral administration will be provided as 600-mg film-coated compressed tablets.
16063830|NCT02426918|Drug|Debio 1450 Oral Placebo|Debio 1450 placebo will be supplied as white, opaque, hard gelatin capsules.
16063831|NCT02426918|Drug|Linezolid Placebo|Linezolid placebo will be supplied as film-coated compressed tablets.
16063832|NCT02426918|Drug|Vancomycin IV|Vancomycin will be administered BID every 12 ± 2 hours at doses of 1 g or 15 mg/kg as specified in local protocols, with the infusion rate adjusted to 2 hours.
16063833|NCT02426905|Drug|trientine dihydrochloride|A retrospective review of patients' medical records
16063834|NCT02426892|Biological|ISA 101|100 mcg administered subcutaneously for a total of 3 doses at 3 to 4 weeks intervals starting on Day 1.
16063835|NCT02426892|Drug|Nivolumab|3 mg/kg administered by vein every 2 weeks beginning on Day 8 after the first vaccine dose.
16063836|NCT02426879|Procedure|esophagectomy with three-field lymphnode dissection|robot assisted thoraco-laparoscopic esophagectomy with three-field lymphnode dissection
16063837|NCT02426866|Drug|Efavirenz|
16063838|NCT02426853|Behavioral|Questionnaires|Participants complete 1 questionnaire at beginning of study, 1 after receiving education about how to protect skin from sun and how to avoid tanning beds, and 1 at about 3 months after receiving skin protection education.
16063839|NCT02426853|Other|Photos|At beginning of study, 2 photos taken of the face. One photo is a standard photo, the other photo is taken with an ultraviolet (UV) filter.
16063840|NCT02426853|Behavioral|Pamphlets|At beginning of study, handouts given that discusses skin cancer prevention, sun protection, and how to avoid tanning beds.
16063841|NCT02426840|Dietary Supplement|High dose vitamin D and calcium|participants will receive a FDC tablet containing 1500 mg of calcium carbonate (equivalent to 600 mg of elemental calcium) and 200 IU of vitamin D3. This drug will be administered as 1 tablet orally twice daily and is to be taken with food. In addition, participants will receive vitamin D2 capsule containing 20,000 IU of ergocalciferol, which will be administered as 1 capsule orally once weekly at any time (not related with meal).
16063842|NCT02426840|Dietary Supplement|Normal dose vitamin D and calcium|participants will receive a FDC tablet containing 1500 mg of calcium carbonate (equivalent to 600 mg of elemental calcium) and 200 IU of vitamin D3. This drug will be administered as 1 tablet orally twice daily and is to be taken with food
16063843|NCT02426827|Device|Spinal Cord Stimulation|
16063844|NCT02426814|Device|Inhaler sensor|Inhaler sensor strap that tracks inhaler use.
16063845|NCT02426814|Behavioral|Mobile application for asthma adherence|Mobile phone application that sends reminders and allows patients to self-manage their medication adherence.
16063846|NCT02426801|Device|Inhaler sensor|Inhaler sensor strap that tracks inhaler use via a pressure sensitive switch.
16063847|NCT02426801|Behavioral|Mobile application for asthma adherence|Mobile phone application that sends reminders, allows patients to see their medication use, and provides points and other incentives for medication use.
16063918|NCT02426333|Other|Abiraterone Acetate|Exclusively determine pharmacokinetics and pharmacodynamics of abiraterone for the indication according to the drug label (CRPC)
16063848|NCT02426788|Behavioral|Cognitive behavioural therapy (CBT)|Behavioral: Cognitive behavioural therapy (CBT) The CBT intervention used in the trial has been adapted for people with PPS and it is based on a model of understanding PPS (Deary et al 2007). The therapy aims to help the patient develop an understanding of the relationship between cognitive, physiological and behavioural aspects of their problem; to understand factors that may be maintaining the problem and to learn how to modify their behavioural and cognitive responses in order to improve quality of life. The approach is transdiagnostic in that it targets processes and underlying mechanisms that affect disorders similarly, rather than focusing on how they are diagnostically different. The approach is personalised during therapy following a detailed assessment.
16063849|NCT02426775|Drug|Carglumic Acid|Carglumic Acid 50 mg/kg/day (twice daily)
16063850|NCT02426762|Procedure|Laparoscopic surgery|"Various laparoscopic operations are performed for participants. Once all surgical procedures are successfully applied, surgical wounds which are associated with laparoscopic surgery would be sealed by a quick sealant. In all, the following surgical wounds would be left:
~4-5 trocar-produced incisions (5/10mm, minor incision)
~1 sample-retrieval incision (4-5cm, small incision)"
16063851|NCT02426762|Device|Skin sealant|After surgery, a quick skin sealant is applied in two layers of each wound to achieve skin closure. The sealant would be smeared twice on the wound area with 30 seconds of dry time required to form a firm seal.
16063852|NCT02426749|Device|Active repetitive Transcranial Magnetic Stimulation (rTMS)|The treatments will be administered daily (five days/week) for two weeks, followed by three days on the third week (total of 13 treatments). Patients of both real and sham treatment groups will undergo rTMS treatment of 1.5-second duration trains of pulses at 20 Hz for a total of 25 trains with intertrain interval of 10 seconds applied to DLPFC bilaterally at 100% of the resting motor threshold. Thus, there will be a total of 1500 pulses per two sides of the brain per day, which is well within the safety limit of the rTMS application. During the intertrain intervals, the patients will be presented a series of objects and actions and asking to name them. The images will be projected on the wall in front of patient with duration of three seconds for each image. The aim is to keep the brain active while we stimulate it with rTMS.
16063853|NCT02426749|Device|Sham repetitive Transcranial Magnetic Stimulation (rTMS)|Sham rTMS is similar to Active rTMS but instead of a real coil, it uses a coil that attenuates the pulses such that no current will be induced in the brain.
16063854|NCT02426736|Drug|Dexamethasone|
16063855|NCT02426736|Drug|Bupivacaine|
16063856|NCT02426736|Procedure|Interscalene brachial plexus block|Performed with real time ultrasound guidance.
16063857|NCT02426723|Drug|Phase 1a: CWP232291|CWP232291 administered alone twice weekly every 4 weeks.
16063858|NCT02426723|Drug|Phase 1b: CWP232291, Lenalidomide, Dexamethasone|CWP232291 administered twice weekly every 4 weeks. Lenalidomide and Dexamethasone administered per standard therapy.
16063859|NCT02426710|Device|Intracardiac echocardiography|Flutter ablation will be done using intracardiac echocardiography.
16063860|NCT02426697|Drug|fentanyl transmucosal|Participation to the trial will be proposed to the patient by the investigator in charge of the analgesic irradiation during preliminary scanner session. When starting the radiotherapy session, investigator will collect the signed inform consent form, deliver the treatment, will collect pain intensity value using VAS (before and after the radiotherapy session).
16063861|NCT02426697|Drug|Placebo|Participation to the trial will be proposed to the patient by the investigator in charge of the analgesic irradiation during preliminary scanner session. When starting the radiotherapy session, investigator will collect the signed inform consent form, deliver the treatment, will collect pain intensity value using VAS (before and after the radiotherapy session).
16063862|NCT02426684|Drug|IdeS®|First ten patients will receive 0.24mg/kg, if no PK/PD/safety/tolerability issues are observed, dose will increased to 0.5mg/kg IdeS on day 0 for final 10 patients. (n=20)
16063863|NCT02426671|Device|MuteButton sensory stimulation device|Participants are asked to use the MuteButton daily for 30-40 minutes. They receive 'pink noise' through headphones and transcutaneous stimulation on the tongue using a 'lollipop' sensor that sits on the anterior section (tip) of the tongue.
16063864|NCT02426658|Other|Laboratory Biomarker Analysis|Correlative studies
16063865|NCT02426658|Drug|Pemetrexed Disodium|Given IV
16063866|NCT02426658|Other|Quality-of-Life Assessment|QOL studies
16063867|NCT02426632|Drug|Formulation A|Reference formulation, 10 milligram/milliliter (mg/mL)oral solution without sweetener/flavor.
16063868|NCT02426632|Drug|Formulation B|10 mg/mL oral solution containing 2 mg/mL sucralose, masking flavor and orange flavor.
16063869|NCT02426632|Drug|Formulation C|10 mg/mL oral solution containing 10 mg/mL sucralose.
16063870|NCT02426632|Drug|Formulation D|10 mg/mL oral solution containing 2 mg/mL sucralose and raspberry flavor.
16063871|NCT02426632|Drug|Formulation E|10 mg/mL oral solution containing 2 mg/mL sucralose and strawberry flavor.
16063872|NCT02426632|Drug|Formulation F|10 mg/mL oral solution containing 2 mg/mL sucralose and orange flavor.
16063873|NCT02426632|Drug|Formulation M1|Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
16063874|NCT02426632|Drug|Formulation M2|Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
16063875|NCT02426632|Drug|Formulation M3|Best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
16063876|NCT02426632|Drug|Formulation N1|Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
16063877|NCT02426632|Drug|Formulation N2|Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
16063878|NCT02426632|Drug|Formulation N3|Second best scoring formulation from Session 1 with a varying concentration of sucralose (maximum 10 mg/mL).
16063879|NCT02426619|Device|SDF solution|around 1 mL of 30% silver diammine fluoride (SDF) solution is placed in a small disposable container and a small brush will be used to apply a very small quantity of the solution onto the surface of the dental caries lesion in the tooth
16063880|NCT02426619|Device|NaF varnish|around 1 mL of 5% NaF (sodium fluoride) varnish is placed in a small disposable container and a small brush will be used to apply a very small quantity of the solution onto the surface of the dental caries lesion in the tooth
16063919|NCT02426320|Other|Sedation Interruption Protocol|
16063920|NCT02426320|Other|Standard Sedation Protocol|
16063881|NCT02426606|Other|Various lentil varieties (varying in slow digested starch content)|"Randomized, cross-over block design.
~Comparison of glycemic and insulinemic responses following meals composed of:
~white rice or white rice combined with 1 of 3 different lentil varieties or
~white potato or white potato combined with 1 of 3 different lentil varieties
~Participants with be assigned to either the white rice or white potato group. Meals will provide 50g available carbohydrate (AC). In meals containing lentils, whole cooked lentils will provide 25g AC either white rice or white potato will provide 25g AC.
~Meals will be randomly consumed across 6 study visits, with 2 white bread control meals (one of which will take place on the first visit)."
16063882|NCT02426593|Device|IMED-4|Non-invasive novel lung hydration status sensor.
16063883|NCT02426580|Behavioral|wechat|The wechat model of dietary education every 1 month by cellphone
16063884|NCT02426567|Other|Exclusive Enteral Nutrition (EEN)|One week course of an isocaloric exclusive milk-based diet
16063885|NCT02426567|Other|Crohn's Disease TReatment-with-EATing diet (CD-TREAT diet)|One week course of an isocaloric, exclusion food-based diet
16063886|NCT02426554|Dietary Supplement|DDU-supplement|DDU: Vitamin D, DHA, Uridine
16063887|NCT02426554|Dietary Supplement|Placebo supplement|
16063888|NCT02426541|Drug|Dapagliflozin|Dapagliflozin 10 mg Tablets, Oral, Once Daily, 8 weeks
16063889|NCT02426541|Drug|Placebo|Matching placebo to Dapagliflozin 10 mg Tablets, Oral, Once Daily, 8 weeks
16063890|NCT02426528|Other|Cultural and Social exposure|"The intervention protocol will consist of 24 months of guided exposure and participation in social and cultural activities undertaken in the Casa del Popolo. The participant will be asked to register for a specific type of event (fine arts, performing arts, and social and volunteering activities), duration and date in order that this information can be supplied for further evaluation. Control group participants will be asked to carry on their lives normally and maintain regular cultural and social activity throughout the duration of the study. At twelve months from the beginning of the observation participants of both groups will be checked (intermediate phase)."
16063891|NCT02426515|Device|Hilotherm® cooling device and face mask|Hilotherm® is an external cooling device and facial mask through which water circulates at a controlled temperature This allows continuous cooling of the face, and is thought to reduce post-operative swelling and pain.
16063892|NCT02426502|Drug|Conversion to Advagraf|Prograf treated patients will convert to Advagraf using a 1: 1 conversion for a period of one week. The dose will then be titrated based on tacrolimus trough levels obtained 7 days after conversion. Cyclosporine (Neoral) treated patients will initiate Advagraf 0.075 mg/kg/day, 24 hours after their last cyclosporine dose. Participants will be provided with Advagraf and instructed how to start this new medication
16063893|NCT02426502|Drug|conversion of non-immunosuppressant drugs to once daily|"Conversion of anti-hypertensive medications: converted to once daily alternatives with the goal of maintaining blood pressure at the same or lower level prior to conversion.
~Conversion of all other medications: changed to once daily formulations of the same medication or a once daily alternative."
16063894|NCT02426502|Drug|Conversion to once daily MPA|"Conversion to once daily MPA: Patients taking mycophenolate mofetil (MMF) will receive 1.0 gram once daily, while patients receiving Myfortic will receive 720 mg once daily.
~Conversion to once daily Myfortic: Patients prescribed proton pump inhibitors (PPIs) and MMF will be switched to equivalent dose Myfortic for a period of one month prior to conversion to once daily MPA.
~Patients taking azathioprine will be maintained on the same dose.
~Patients will be maintained on the same prednisone dose."
16063895|NCT02426489|Device|MRI + PEM image|Effect of positron emission mammography on diagnostic accuracy
16063896|NCT02426476|Behavioral|active heart rate variability biofeedback training|resonant frequency breathing, attention focusing, positive emotional state
16063897|NCT02426476|Behavioral|sham HRVB training|passive relaxation
16063898|NCT02426463|Drug|propofol|
16063899|NCT02426463|Drug|oxycodone|
16063900|NCT02426450|Procedure|RFA|"RFA:
~RFA was performed by using a commercially available system (RF 2000; Radio-Therapeutics Mountain View, CA), and a needle electrode with a 15 Ga insulated cannula with 10 hook-shaped expandable electrode tines with a diameter of 3.5 cm at expansion (LeVeen; RadioTherapeutics)."
16063901|NCT02426450|Drug|Oxaliplatin|4 weeks after RFA; Drug: Oxaliplatin Day 1: Oxaliplatin 85mg/m² 2h IV infusion. Repeated every 2 weeks
16063902|NCT02426450|Drug|5-Fluorouracil/Leucovorin|"4 weeks after RFA; Drug: 5-Fluorouracil/Leucovorin Day 1, after Oxaliplatin 85mg/m² 2h IV infusion: Leucovorin 200mg/m² 2h IV infusion, 5-fluorouracil 400mg/m² IV bolus, 5-fluorouracil 600mg/m2 22h IV infusion.
~Day 2: Leucovorin 200mg/m² 2h IV infusion, 5-fluorouracil 400mg/m² IV bolus, 5-fluorouracil 600mg/m² 22h IV infusion.
~Repeated every 2 weeks"
16063903|NCT02426437|Other|Pulmonary Rehabilitation (PR)|Patients enrolled in PR will undergo a 6-8 week rehabilitation program.
16063904|NCT02426437|Other|Usual Care|Patients enrolled in usual care will be followed-up by their most responsible physician as determined by the admitting team.
16063905|NCT02426424|Device|Watchpat|WatchPAT ™ is an FDA-approved portable diagnostic device that uses the most innovative technology to ensure the accurate screening, detection, and the follow-up treatment of sleep apnea.
16063906|NCT02426424|Device|CPAP|Continuous positive airway pressure (CPAP) is a form of positive airway pressure ventilator, which applies mild air pressure on a continuous basis to keep the airways continuously open in a patient who is able to breathe spontaneously on his or her own.
16063907|NCT02426411|Drug|EMA401 200 mg|
16063908|NCT02426411|Drug|EMA401 600 mg|
16063909|NCT02426411|Drug|Placebo|
16063910|NCT02426385|Device|FineVision Toric|Posterior chamber IOL which consists in a small plastic lens with plastic side struts, called haptics, to hold the lens in place within the capsular bag inside the eye
16063911|NCT02426372|Biological|QBECO SSI|QBECO Site Specific Immunomodulators
16063912|NCT02426359|Drug|Q301 Cream|
16063913|NCT02426359|Drug|Placebo|
16063914|NCT02426346|Behavioral|Behavioral weight control|Prescription of diet & physical activity and behavioral strategies for weight control
16063915|NCT02426346|Behavioral|Group-based physical activity|Teens exercise for 60 minutes with their group
16063916|NCT02426346|Behavioral|Group-based incentives|Adolescents earn reinforcements within group
16063917|NCT02426346|Behavioral|Parent-based incentives|Adolescents earn reinforcements from their parents (outside of group)
16063921|NCT02426307|Procedure|TAVR|TAVR: Transcatheter Aortic Valve Replacement
16063927|NCT02426255|Other|Collection of medical data from ICU patients|A code will be applied to each patient included. Medical data such as demography, Simplified Acute Physiological Score II (SAPS II), Sequential Organ Failure Assessment (SOFA), procedures and complications during ICU stay will be collected.
16063928|NCT02426242|Other|Collection of medical data from ICU patients|A code will be applied to each patient included. Medical data such as demography, ISS, clinical exam at time of extubation, extubation failure, tracheotomy, will be collected during ICU stay.
16063929|NCT02426229|Drug|dabigatran etexilate|dabigatran etexilate 75mg orally twice a day for 6 months
16063930|NCT02426203|Procedure|Pulmonary endarterectomy|Echocardiographic assessment right ventricular function prior to, during, and following Pulmonary Endarterectomy surgery.
16063931|NCT02426190|Other|Anti-gravity treadmill|The intervention is to ask study participants to ambulate using an anti-gravity treadmill that integrates patented, NASA Differential Air Pressure (DAP) technology -- a precise air calibration system -- to uniformly reduce gravitational load and body weight during the warm-up phase of an outpatient physical therapy following a single total knee replacement.
16063932|NCT02426190|Other|PENS - neuro-muscular stimulation|The intervention is to ask study participants to warm up using Patterned Electrical Neuromuscular Stimulation (PENS) - that closely replicates the body's normal muscle and nerve firing patterns -- on his/her surgical leg in conjunction with a recumbent bike or a Nu-step bike during the warm-up phase of an outpatient physical therapy following a single total knee replacement.
16063933|NCT02426190|Other|Anti-gravity treadmill & PENS - neuro-muscular stimulation|The intervention is to ask study participants to ambulate using an anti-gravity treadmill in conjunction with use of Patterned Electrical Neuromuscular Stimulation (PENS) during the warm-up phase of an outpatient physical therapy following a single total knee replacement.
16063934|NCT02426190|Other|Recumbent or Nu-step bike|This is the active comparator of the trial that participants are asked to use either a recumbent or Nu-step bike normally seen in an outpatient physical therapy clinic to warm-up during a physical therapy session following a single total knee replacement.
16063935|NCT02426177|Drug|Labetalol|anti-hypertensive agents
16063936|NCT02426177|Drug|Nifedipine|calcium channel blocker ,for lowering blood pressure
16063937|NCT02426164|Drug|Liposomal bupivacaine|Periarticular infiltration of the liposomal bupivacaine with 20cc of normal saline
16063938|NCT02426164|Drug|bupivacaine HCl, morphine, epinephrine, methylprednisolone|Periarticular infiltration of 24c of bupivacaine HCl, 0.8cc morphine, 0.3cc epinephrine, and 1cc of methylprednisolone
16063939|NCT02426151|Drug|BEPO-A|BEPO-A (Bioreactor manufacturing process)
16063940|NCT02426151|Drug|REPO-A|REPO-A (Roller bottle manufacturing process)
16063941|NCT02426138|Other|Medically Tailored Meal Delivery (MTM)|Patients will receive delivery of medically tailored meals for 12 weeks
16063942|NCT02426138|Other|Usual Care + Choose MyPlate|Patients will receive usual diabetes care + a Choose MyPlate healthy eating brochure for 12 weeks
16063943|NCT02426125|Drug|Ramucirumab|Administered IV
16063944|NCT02426125|Drug|Docetaxel|Administered IV
16063945|NCT02426125|Drug|Placebo|Administered IV
16063946|NCT02426112|Drug|Azithromycin|
16063947|NCT02426112|Drug|Placebo|
16063948|NCT02426099|Drug|Low dose spironolactone|4-week add-on low dose spironolactone in resistant hypertension
16063949|NCT02426099|Other|Routine intensification of antihypertensive treatment|4-week guidelines oriented intensification of antihypertensive treatment
16063950|NCT02426086|Drug|Imetelstat 4.7 mg/kg|Participants received imetelstat 4.7 mg/kg of body weight as intravenous infusion on Day 1 of each 21-day cycle. Study drug was administered intravenously until disease progression, unacceptable toxicity, or study end.
16063951|NCT02426086|Drug|Imetelstat 9.4 mg/kg|Participants received imetelstat 9.4 mg/kg of body weight as intravenous infusion on Day 1 of each 21-day cycle until disease progression, unacceptable toxicity, or study end.
16063952|NCT02426060|Drug|Imrecoxib|
16063953|NCT02426060|Drug|Warfarin|
16063954|NCT02426047|Dietary Supplement|betaquik®|Participants will add betaquik® (a liquid emulsion of medium chain triglycerides) for a 10 day time interval starting 2 days prior to and encompassing the primary catamenial pattern.
16063955|NCT02426034|Drug|ApatinibTablets|Apatinib Tablets, recommended dose of 850mg
16063956|NCT02426021|Drug|MLN1202|Subcutaneous administration of MLN1202
16063957|NCT02426021|Drug|MLN1202 Placebo|Subcutaneous administration of MLN1202 placebo
16063958|NCT02426008|Other|Growth Factors and Cytokine adding to embryo culture media|
16063959|NCT02426008|Other|No Intervention|Nothing to Add
16063960|NCT02425995|Procedure|Arthroscopic intercondylar and posteromedial portal|Diagnosis of lesions of the Posterior Horn of the Medial Meniscus in Arthroscopic intercondylar and posteromedial portal in addition with standard ACL reconstruction, during the same surgery.
16063961|NCT02425982|Procedure|Operative treatment|The exact treatment depends on the surgeon, but the majority are anticipated to be elbow arthroscopy followed by either arthroscopic or open extensor carpi radialis brevis release.
16063962|NCT02425982|Procedure|Conservative treatment|The treatment consists of physiotherapy, activity modification, pain medication and watchful waiting. Injection therapies will be avoided.
16063963|NCT02425969|Procedure|PCI|Patients will have balloon angioplasty and coronary stent insertion for their grey-zone FFR lesion.
16063964|NCT02425969|Drug|Optimal Medical Therapy|Optimal Medical therapy consists of secondary prevention which will include high dose statin and aspirin as well as anti-anginal therapy according to ESC 2013 international treatment guidelines for stable angina as follows; B-Blocker or Calcium channel blocker as first line agents and Nicorandil or Nitrates or Ranolazine as second line treatment titrated against symptoms to maximum tolerated dose. ACE inhibitors or Angiotensin Receptor Blockers will be prescribed if patients also have a diagnosis of hypertension, LVEF ≤40%, diabetes or CKD where appropriate.
16063965|NCT02425956|Device|GE Optima/Discovery® MRI data of the liver|GE Optima 1.5T®/Discovery 3.0T® MRI data scanning data of the liver and surrounding tissues will be acquired using both field strengths for GE IDEAL IQ® and single field strength with FerriScan® (Resondence Health) Specialized Reconstruction Service, according instructions provided by manufacturer
16063966|NCT02425943|Device|injectable poly-L-lactic acid Sculptra Aesthetic|
16064737|NCT02420535|Behavioral|One Month Delay|
16063967|NCT02425930|Procedure|gastrectomy plus D2 lymphadenectomy|A classic total or subtotal gastrectomy plus D2 lymph nodes dissection would be performed for all enrolled patients. Patients in both groups would undergo the identical therapeutic approach for gastric cancer, mainly decided by a multidisciplinary treatment group in our center.
16063968|NCT02425930|Drug|S-1+Oxaliplatin|"A postoperative systemic chemotherapy would be performed for some subjects who have advanced gastric cancer. The concrete chemo regimen for adjuvant chemotherapy is also determined by a MDT group. Generally, SOX chemo regimen is the first-line treatment in our center, as following described:
~S-1: 40~60mg bid，po, Day1~14 （S-1：BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid）
~Oxaliplatin: 130mg/m2，iv drip for 2h，Day1"
16063969|NCT02425917|Device|geko|neuromuscular electrostimulator
16063970|NCT02425917|Device|IPC-Calf|IPC used on calf with or without geko
16063971|NCT02425904|Drug|Clofarabine|Evaluation of response to clofarabine
16063975|NCT02425878|Drug|Ulipristal Acetate|
16063976|NCT02425878|Drug|Placebo|
16063977|NCT02425865|Drug|GOLIMUMAB|Increase/ or Decrease/ Interruption Dose of Golimumab depending on Continuous Clinical Response or Relapse
16063978|NCT02425852|Drug|Azathioprine|Azathioprine alone versus Azathioprine and IFX
16063979|NCT02425852|Drug|Infliximab|
16063980|NCT02425852|Drug|Prednisolone|
16063981|NCT02425852|Drug|Hydrocortisone|
16063982|NCT02425839|Device|Ultrasound exam by Supersonic Shear Imaging® technique|Each of the two observers performs twice ultrasound examination and measures of the masseter thickness and its elastic modulus, at rest and maximal voluntary contraction.
16063983|NCT02425839|Device|EMG examination by electromyograph Keypoint system|Experimented neurologist performs EMG examination.
16063984|NCT02425826|Drug|Apremilast|Apremilast 30 mg tablets orally twice daily (BID) weeks 0 to 52.
16063985|NCT02425826|Drug|Placebo|Participants randomized to the placebo treatment group received placebo tablets (identical in appearance to the apremilast 30 mg tablets) orally BID for from weeks 0-16.
16063986|NCT02425826|Drug|Placebo-Apremilast|At Week 16, those randomized to placebo were switched to apremilast 30mg BID for an additional 36 weeks (52 weeks total)
16063987|NCT02425813|Drug|Budesonide|Given PO
16063988|NCT02425813|Drug|Methylprednisolone Sodium Succinate|Given IA and IV
16063989|NCT02425800|Other|Cytology Specimen Collection Procedure|Undergo collection of tissue samples
16063990|NCT02425800|Other|Laboratory Biomarker Analysis|Correlative studies
16063994|NCT02425774|Procedure|Vagus stimulation|
16063995|NCT02425774|Procedure|Sham stimulation|
16063996|NCT02425774|Drug|Prucalopride|
16063997|NCT02425774|Drug|Placebo|
16063998|NCT02425761|Procedure|Ventriculoperitoneal shunt insertion surgery|The most common treatment for hydrocephalus is the placement of a ventriculoperitoneal shunt in the operating room. A shunt is a flexible tube placed into the ventricular system, fluid filled chambers, of the brain that diverts the flow of CSF into another region of the body, usually the abdomen, also known as the peritoneal cavity, where it can be absorbed.
16063999|NCT02425748|Biological|DC-CIK|DC-CIK cells will be used against tumor cells.
16064000|NCT02425748|Biological|γδ T Cell|γδ T cells will be used against non small lung tumor.
16064001|NCT02425748|Biological|γδ T/DC-CIK cells|γδ T/DC-CIK cells will be used against lung tumor.
16064002|NCT02425735|Biological|DC-CIK cells|DC-CIK cells will be used against tumor cells.
16064003|NCT02425735|Biological|γδ T cells|γδ T cells will be used against breast tumor.
16064004|NCT02425735|Biological|γδ T/DC-CIK cells|γδ T/DC-CIK cells will be used against breast tumor.
16064005|NCT02425722|Drug|ASP0456|oral
16064006|NCT02425722|Drug|Placebo|oral
16064007|NCT02425709|Drug|Diclofenac|Women will receive oral diclofenac 50 mg 1 hour before the procedure
16064008|NCT02425709|Drug|Tramadol|Women will receive oral tramadol 50 mg 1 hour before the procedure
16064009|NCT02425709|Drug|Placebo|Women will receive an oral placebo 1 hour before the procedure
16064010|NCT02425683|Drug|Regorafenib|120 mg or 160 mg by mouth each day for first 21 days of each 28-day cycle, for maximum of 6 cycles
16064011|NCT02425670|Other|BMSCs|30-500 million Autologous BMSCs will be given intravenously to patients with acute ischemic stroke (onset from 7 to less than 30 days).
16064012|NCT02425657|Behavioral|Training of junior doctors|Training program
16064890|NCT02419612|Other|Placebo|
16064014|NCT02425644|Drug|teriflunomide|film-coated tablet with 14 mg teriflunomide, administered orally once daily in the morning
16064015|NCT02425631|Device|SImmetry Sacroiliac Joint Fusion System|Minimally invasive surgery for implantation of the SImmetry System
16064016|NCT02425605|Radiation|CCRT|The subject is treated with a total of 45 Gy of external beam radiotherapy (1.8 Gy per session, 5 sessions a week, for 5 weeks), with hepatic arterial infusion of 5-flourouracil (5-FU) during the first and last 5 days of radiation therapy (5-FU 500 mg infusion for 5 hours) for radiosensitization through the pre-inserted chemoport.
16064017|NCT02425605|Drug|sorafenib|Four weeks after completion of CCRT, the subject is given daily sorafenib treatment and will be followed for survival.
16064018|NCT02425579|Drug|Inhaled Carbon Monoxide at 100ppm (4 participants)|Inhaled Carbon Monoxide at 100ppm for up to 90 minutes daily for 5 days
16064019|NCT02425579|Drug|Placebo for Inhaled Carbon Monoxide at 100ppm (2 participants)|Inhaled Medical Air for up to 90 minutes daily for 5 days
16064020|NCT02425579|Drug|Inhaled Carbon Monoxide at 200ppm (4 participants)|Inhaled Carbon Monoxide at 200ppm for 90 minutes daily for 5 days
16064021|NCT02425579|Drug|Placebo for Inhaled Carbon Monoxide at 200ppm (2 participants)|Inhaled Medical Air for up to 90 minutes daily for 5 days
16064022|NCT02425566|Drug|Trimethaphan|Trimethaphan is a Nn-nicotinic receptor antagonist that blocks sympathetic and parasympathetic transmission at the level of the autonomic ganglia. It will be administered as an acute intravenous infusion with doses ranging from 0.5 to 5.0 mg/min.
16064023|NCT02425566|Drug|Nitroglycerin|Sublingual nitroglycerin (0.3-0.6 mg) will be given after baseline measurements.
16064024|NCT02425553|Other|Diet|High calorie (1200 kcal), high fat (50% energy), 400 ml juice (230 kcal)
16064025|NCT02425553|Other|Diet|High calorie (1200 kcal), low fat (20% energy), 400 ml juice (230 kcal)
16064026|NCT02425553|Other|Diet|Low calorie (600 kcal), low fat (20% energy), 400 ml juice (230 kcal)
16064027|NCT02425553|Other|Diet|High calorie (1200 kcal), high fat (50% energy), 300 ml wine (40 g alcohol, 230 kcal), 100 ml water
16064028|NCT02425540|Device|Pelvic MRI|
16064029|NCT02425527|Behavioral|The rehabilitation gaming|The web-based cognitive training platform CogniFit includes about 33 mini games designed with the purpose of improving the user's cognitive abilities as brain exercises. For the purpose of the research, a selection of CogniFit mini games will be included in the intervention. The mini game tasks will be adapted to players' skills getting more difficult as the players progress. The game tasks are targeting different cognitive abilities such as memory, visual-spatial ability, attention, tracking and fast decision making.
16064030|NCT02425527|Behavioral|The entertaining gaming|The gameplay will consist of these main elements: 1) the player will be playing the main character of the game, 2) the character will be presented for the player from an isometric perspective, 3) the player will control the character by navigating in partly open-ended 3D environments in which the player must decide a direction and move towards it by avoiding obstacles; 4) the player will engage with real-time action events and act quickly by making strategic and tactical decisions; 5) the player must memorize locations, characters, dialogue and tasks; as well as 6) track, follow or aim at several objects simultaneously. Gaming requires also patience as participants can only make progress in games by trial and error.
16064031|NCT02425514|Device|Cervios ChronOs|The ACDF surgery will be carried out with Cervios ChronOs after randomization procedure.
16064032|NCT02425514|Device|NovoMax™|The ACDF surgery will be carried out with NovoMax™ after randomization procedure.
16064033|NCT02425501|Drug|Aflibercept (Eylea, BAY86-5321)|Administration by intravitreal injection
16064034|NCT02425488|Behavioral|Nursing therapeutics education|"Educational intervention will focus on
~Appropriate lifestyles
~Early recognition of signs/prodromal symptoms of HF
~Early recognition of signs of inflammation of the ICD-pocket
~Good management of the device
~1) Therapy, body weight, diet, smoking, alcohol, rest, exercise, job and sex 2) Dyspnea, edema and fovea, rapid weight gain, loss of appetite, fatigue, asthenia, insomnia, mental confusion 3) Signs and symptoms of inflammation: hyperpyrexia, rubor, dolor, calor and tumor 4) Identification tag, vibration, metal detectors, air travel, use of electronic devices, diagnostic PET and MRI"
16064035|NCT02425475|Device|LIMES|All patients will undergo dermoscopic diagnosis and be documented with a video image storing. The diagnosis based on dermoscopy will be immediately documented. Then, as a second diagnostic procedure, fluorescence diagnostics based on the two photon excitation from a dye-laser will be performed. The classification as non-melanoma or malignant melanoma by the medical device LIMES will also be documented immediately. Afterwards, the lesion will be excised and undergo histo-pathologic examination by the respective histopathologist of the participating centers. The histopathologic diagnosis will serve as gold standard for subsequent evaluations of the diagnostic accuracy.
16064036|NCT02425462|Drug|Dienogest (Visanne, BAY86-5258)|Dienogest 2mg daily Oral dose
16064037|NCT02425449|Drug|Succinylcholine|will be administered succinylcholine in a dose of 0.1 mg/kg in Arm 1, 0.15 mg/kg in Arm 2, 0.2 mg/kg in Arm 3, 0.25 mg/kgin Arm 4, 0.3 mg/kg in Arm 5.
16064038|NCT02425436|Drug|Ginkgo Biloba Extract|
16064039|NCT02425436|Other|Placebo|
16064040|NCT02425423|Dietary Supplement|New thickened formula|
16064041|NCT02425410|Other|Collect of data on viral environment of T1D patients|Questionnaires on viral events during mother's pregnancy and patient's childhood, health book copies, addresses' geolocation, quantification of viral exposures using Sentinel Network data
16064042|NCT02425410|Genetic|Collect of blood samples for DNA extraction and genetic characterization (GWAS)|Collect of blood samples for DNA extraction and genetic characterization (GWAS) on Illumina platform (Centre National de Genotypage)
16064043|NCT02425397|Genetic|Genetic study|study of mutations of metabolic enzymes and membrane transport genes, which will be performed by sequencing.
16064044|NCT02425397|Genetic|Genetic study MT-RN1|study of mutations of the mitochondrial gene MT-RN1, which will be performed by sequencing.
16064045|NCT02425384|Behavioral|Intervention Group (motivational website, activity meter)|The activity meter linked to a motivational website is designed to motivate middle school-aged children to increase their rates of physical activity by providing feedback on the amount of activity, and rewards based on the amount and duration of activity.
16064118|NCT02424851|Drug|Bendamustine|60 mg/m2 i.v. days 1 and 8 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
16064046|NCT02425384|Behavioral|Active Control (active video game, activity meter)|The active video game, Dance Dance Revolution, requires physical movement as part of game play and may motivate users to engage in more activity. The same activity meter used in the Intervention Group is provided to this group to track physical activity but does not link to the motivational website nor does it provide any feedback on levels or duration of activity.
16064047|NCT02425384|Other|Passive Control (activity meter)|Participants are provided the same activity meter used in the other study groups to track physical activity but it does not link to the motivational website nor does it provide any feedback on levels or duration of activity. Participants are asked to go about their normal activities.
16064048|NCT02425371|Other|Screening and treatment of comorbidities|Screening and treatment of comorbidities
16064049|NCT02425371|Other|Placebo Comparator|No screening of comorbidities
16064050|NCT02425358|Other|BMC therapy within 24 hours|The BMCs were isolated by Ficoll density gradient centrifugation on Lymphocyte Separation Medium. BMCs were infused into IRA at the site of the previous occlusion. This was accomplished with the use of a microtubular. After positioning of the microtubular into the distal segment vessel of the stent position in the infarct-related artery, 15 milliliter of the whole cell suspension was slowly administered via microtubular. The usual time should be over 10min to prevent back-flow and to prolong cellular contact time for cellular migration into the tissue. Patients in BMC therapy group within 24 hours remained in the cath-lab until the entire procedure, including primary PCI and intracoronary BMC infusion, was completed.
16064051|NCT02425358|Other|BMC therapy within 3-7 days|Patients in this group, who underwent a second procedure, to receive BMC transplantation in the cath-lab during the same hospitalization or returned for a second hospitalization.
16064052|NCT02425358|Other|BMC therapy within 7-30 days|Patients in this group, who underwent a second procedure, to receive BMC transplantation in the cath-lab during the same hospitalization or returned for a second hospitalization.
16064053|NCT02425358|Other|PCI only|The saline was intracoronary infusion with the use of microtubular.
16064054|NCT02425345|Behavioral|Physical Activity|The PA intervention will consist of a multimodal activity program of aerobics, balance, strength, flexibility. The intervention will involve encouraging participants to increase all forms of PA throughout the day and to decrease sedentary time, such as sitting. This may include activities such as leisure sports, gardening, use of stairs instead of escalators, leisurely walks with friends, and less use of remote control devices.The intervention is conducted primarily by mail with website support and resources available.
16064055|NCT02425332|Device|Lokomat gait trainer|
16064056|NCT02425306|Biological|6MHP|6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
16064057|NCT02425306|Drug|Montanide ISA-51|Montanide ISA-51 (Incomplete Freund's Adjuvant), local adjuvant
16064058|NCT02425306|Drug|polyICLC|polyICLC, local adjuvant
16064059|NCT02425306|Drug|Cyclophosphamide|Cyclophosphamide, systemic adjuvant
16064060|NCT02425293|Behavioral|asthma patient education|
16064061|NCT02425280|Behavioral|Narrative Exposure Therapy|
16064062|NCT02425280|Behavioral|Treatment as Usual|
16064063|NCT02425267|Other|Rehabilitation (Physiotherapy)|The training program will be carried out twice a day, and at every day during the eight-week program, either by telerehabilitation or in the clinic or by autonomous unsupervised way. During weeks 1, 3 and 5, the patient will perform his/her exercises twice a week by telerehabilitation/clinic and the other without supervision. During the other weeks (2, 4, 6, 7, 8), the patient will benefit from one exercise session by telerehabilitation/clinic per week and will perform all other without supervision. Supervised sessions allow the therapist and the patient to adjust the program in case of problems and to ensure a smooth implementation of the program.
16064064|NCT02425254|Drug|Intravenous paracetamol|1000mg intravenous solution for infusion
16064065|NCT02425254|Drug|Intravenous saline 0.9%|0.9% sodium chloride in order to ensure double-blinding
16064066|NCT02425241|Biological|pSG2.HIVconsv DNA vaccine|pSG2.HIVconsv DNA 4 mg at weeks 0, 4 and 8.
16064067|NCT02425241|Biological|ChAdV63.HIVconsv booster vaccine|ChAdV63.HIVconsv 5 x 10^10 vp at week 12.
16064068|NCT02425241|Biological|MVA.HIVconsv booster vaccine|MVA.HIVconsv 2 x 10^8 pfu at week 20
16064069|NCT02425241|Drug|CPHPC|40 mg CPHPC IV infusion for 26 hours at weeks 0, 4 and 8 during which pSG2.HIVconsv is administered after 24 hours.
16064070|NCT02425241|Other|Placebo|Placebo IV infusion for 26 hours at weeks 0, 4 and 8 during which pSG2.HIVconsv is administered after 24 hours.
16064071|NCT02425228|Device|Targeted biopsy|conventional/systematic biopsy, targeted fusion biopsy and cognitive biopsy
16064072|NCT02425202|Drug|Ketamine|Post-operative continuous infusion until 0600 the next day
16064073|NCT02425202|Other|Saline infusion|Post-operative continuous infusion until 0600 the next day
16064074|NCT02425176|Drug|Botulinum toxin A (BoNT-A) 50U|"Drug intervention:
~The total dose is divided equally and injected into 4 salivary glands (submandibular and parotid gland bilaterally) via a 25G or 23G needle with ultrasound guidance. One site is injected per gland.
~Drug is only injected once at baseline"
16064075|NCT02425176|Drug|Botulinum toxin A (BoNT-A) 100U|The total dose is divided equally and injected into 4 salivary glands (submandibular and parotid gland bilaterally) via a 25G or 23G needle with ultrasound guidance. One site is injected per gland.
16064076|NCT02425176|Drug|Botulinum toxin A (BoNT-A) 200U|The total dose is divided equally and injected into 4 salivary glands (submandibular and parotid gland bilaterally) via a 25G or 23G needle with ultrasound guidance. One site is injected per gland.
16064077|NCT02425163|Device|Transrectal shear wave elastography of the prostate|Transrectal shear wave elastography of the prostate with SuperSonic Imagine Ultrasound System AIXPLORER and an endocavity sonic head SE12-3 (SuperSonic Imagine, Aix-en-Provence, France)
16064078|NCT02425163|Procedure|Transrectal random biopsy of the prostate|TRUS-SWE-guided random biopsies of the Prostata with 18G-gun
16064079|NCT02425150|Procedure|Corneal reshaping/crosslinking (CRXL)|The keratoconus cornea is treated with epithelial debridement in local anesthesia, is soaked in Riboflavin by repeated topical application during 30 minutes. A flat, rigid contact lens is sutured to the cornea and the cornea and is then irradiated with ultraviolet light 5.4 J/cm2 during 30 minutes.
16064119|NCT02424851|Drug|Dexamethasone|40mg orally days 1-2, 4-5, 8-9 and 11-12 of each cycle
16065793|NCT02413281|Drug|Placebo|Sublingual tablets, single administration
16064080|NCT02425150|Procedure|Corneal Crosslinking (CXL)|The keratoconus cornea is treated with epithelial debridement in local anesthesia, is soaked in Riboflavin by repeated topical application during 30 minutes. The cornea and is then irradiated with ultraviolet light 5.4 J/cm2 during 30 minutes.
16064081|NCT02425137|Drug|S-1/Gemcitabine|Eligible patients will receive gemcitabine 800 mg/m2/day on day 1 and S-1 orally 80-120 mg/day (depending on patient's body surface area (BSA)) on day 1 to 10 in a 2-week cycle.
16064082|NCT02425124|Behavioral|PC101+Mental Health|Facility-based stepped care intervention combining stress and depression case detection and management by non-physician clinicians and referral pathways for anti-depressant medication and/or group/individual counselling delivered by lay-health workers for patients with depression.
16064083|NCT02425111|Drug|Vedolizumab|Vedolizumab intravenous injection
16064084|NCT02425098|Biological|Takeda's Tetravalent Dengue Vaccine Candidate (TDV)|TDV subcutaneous injection
16064085|NCT02425098|Biological|Takeda's High-Dose Tetravalent Dengue Vaccine Candidate (HD-TDV)|High-dose TDV subcutaneous injection
16064086|NCT02425085|Procedure|multi-endodiathermy retinectomy|patients will receive multi-endodiathermy retinectomy; 6 months later, patients will receive the removal of intraocular silicone oil.
16064087|NCT02425085|Procedure|relaxing retinectomy|patients will receive relaxing retinectomy; 6 months later, patients will receive the removal of intraocular silicone oil.
16064088|NCT02425072|Device|NovoTTF-100A plus chemotherapy|NovoTTF-100A System with Physician's Choice Chemotherapy
16064089|NCT02425059|Procedure|Irreversible electroporation (IRE)|Irreversible Electroportion For Unresectable Rectal Neoplasms guide with ultrasound or/and CT.
16064090|NCT02425059|Device|NanoKnife|
16064091|NCT02425046|Behavioral|health coaching|Health coaching using motivational interviewing focus on family diet and exercise change and connection with community resources specific to goals set.
16064092|NCT02425046|Behavioral|community screening|Screening for community resources that families may be eligible for to receive help with basic needs including shelter, food, health insurance etc.
16064093|NCT02425033|Procedure|POEM|Under general anesthesia, patient undergoes upper endoscopy and a small longitudinal submucosal incision is created and a dilating balloon is inserted submucosally via the created incision. The balloon is slightly inflated to allow entrance of the endoscope. The gastroscope is advanced into the submucosal space and the tunnel is created via endoscopic or blunt dissection as appropriate. The tunnel is created distally and is stopped several centimeters beyond the lower esophageal sphincter (LES), which can easily be identified using endoscopic landmarks. Using a dissection knife, the clearly visible circular muscles are divided. The longitudinal layer is left intact and the mucosal entry is closed.
16064094|NCT02425020|Dietary Supplement|Meat Protein|Immediately (<10 min) after completing each training session (resistance training or sport specific workout), participants will consume a beverage containing 20g of meat protein mixed with 250 ml of orange juice and water. On non-training days supplement will be ingested before breakfast.
16064095|NCT02425020|Dietary Supplement|Whey protein|Immediately (<10 min) after completing each training session (resistance training or sport specific workout), participants will consume a beverage containing 20g of whey protein mixed with 250 ml of orange juice and water. On non-training days supplement will be ingested before breakfast.
16064096|NCT02425020|Dietary Supplement|Carbohydrate|Immediately (<10 min) after completing each training session (resistance training or sport specific workout), participants will consume a beverage containing about 20g of maltodextrin mixed with 250 ml of orange juice and water. On non-training days supplement will be ingested before breakfast.
16064097|NCT02425007|Device|Incentive spirometry|
16064098|NCT02424994|Other|No intervention|
16064099|NCT02424981|Device|Threshold inspiratory muscle training|Inspiratory muscle training
16064100|NCT02424968|Biological|Anti-Thymocyte Globulin|Given per standard institutional practice
16064101|NCT02424968|Drug|Cyclosporine|Given PO
16064102|NCT02424968|Drug|Mycophenolate Mofetil|Given PO
16064103|NCT02424968|Procedure|Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplant|Undergo nonmyeloablative allogeneic HSCT
16064104|NCT02424968|Biological|Allogeneic Cluster of Differentiation 8 (CD8)+ Memory T-cells|Receive CD8+ memory T-cells via IV
16064105|NCT02424968|Radiation|Total Nodal Irradiation|Undergo TLI
16064106|NCT02424955|Drug|perflutren lipid microspheres|
16064107|NCT02424955|Diagnostic Test|3D ultrasound|
16064108|NCT02424942|Drug|placebo|"Pharmaceutical form:solvent for parenteral use
~Route of administration: intraarticular"
16064109|NCT02424942|Drug|GZ389988|"Pharmaceutical form:suspension for injection
~Route of administration: intraarticular"
16064110|NCT02424929|Procedure|Sedation|Propofol anesthesia administered during entire surgery.
16064111|NCT02424929|Procedure|Original Surgery|No intervention, surgery will be conducted as usual. With sedation only during the drilling of the burr holes.
16064112|NCT02424916|Biological|Melanoma antigens-specific CD8+ T lymphocytes|The intervention uses an autologous somatic cell therapy medicinal product. It consists in the intravenous injection of melanoma antigens (Melan-A and MELOE-1) - specific CD8+ T lymphocytes followed by subcutaneous injections of Proleukin.
16064113|NCT02424890|Other|MDT simulation sessions of management of life-threatening events over 1 year|9 simulation sessions over 1 year for Repetitive Sim Group and 3 simulation sessions over 1 year for Control Group
16064114|NCT02424877|Procedure|SandRA|SandRA software sends SMS messages to a patient asking questions about the usage and adverse effects of prescribed drugs and about the severity of rheumatoid arthritis. The answer messages are interpreted automatically.
16064115|NCT02424864|Other|4d PET-CT|Patients will be imaged with 4D-CT images in addition to the normal protocol of FDG-CT image acquisition
16064116|NCT02424851|Drug|Bortezomib|"1.3 mg/m2 subcutaneously* days 1, 4, 8 and 11 of each cycle. Number of cycles: Four 21 day cycles (participants not suitable for ASCT (autologous stem cell transplant) will continue up to 6 cycles on the treatment regimen to which they were randomised).
~*intravenous infusion available in case of patient intolerance to subcutaneous bortezomib"
16064117|NCT02424851|Drug|Thalidomide|100 mg daily orally, preferably at night, days 1-21 of each cycle. Four 21 day cycles (participants not suitable for ASCT will continue up to 6 cycles on the treatment regimen to which they were randomised)
16065794|NCT02413268|Drug|Nitroglycerin|
16065795|NCT02413255|Drug|TAK-020|TAK-020 oral solution
16064120|NCT02424838|Procedure|EUS-FNA of pancreatic masses|EUS-FNA of pancreatic masses will be performed using a 22 or a 25 gauge needle with or without applying suction.
16064121|NCT02424838|Device|22 gauge needle|
16064122|NCT02424838|Device|25 gauge needle|
16064123|NCT02424825|Behavioral|Cooking Course|This is a month-long online cooking course, aimed at promoting a low-fat, plant-based diet.
16064124|NCT02424812|Behavioral|Lifebuoy School of Five Handwashing Intervention|
16064125|NCT02424799|Drug|GSK2646264 0.5% topical cream|GSK2646264 0.5% topical cream is supplied as white-to-off-white aqueous cream stored in amber glass jars
16064126|NCT02424799|Drug|GSK2646264 1% topical cream|GSK2646264 1% topical cream is supplied as white-to-off-white aqueous cream stored in amber glass jars
16064127|NCT02424799|Drug|Placebo|Placebo topical cream is supplied as white-to-off-white aqueous cream stored in amber glass jars
16064128|NCT02424786|Other|STOPP/START criteria|Evaluation of medication lists
16064129|NCT02424773|Device|High Flow Nasal Canula (HFNC)|
16064130|NCT02424773|Device|Venturi mask|
16064131|NCT02424773|Drug|Oxygen|
16064132|NCT02424760|Device|Shoulder hemi-arthroplasty|
16064133|NCT02424747|Other|Acute Kidney Injury|"We will identify and observe exposure to Acute Kidney Injury during Intensive Care admission."
16064134|NCT02424734|Drug|Ceftaroline Fosamil|Ceftaroline fosamil will be given at a dose of 6 mg/kg IV over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour).
16064135|NCT02424734|Drug|Ampicillin|Ampicillin IV is required for the first 48 hours if the presence of an organism that requires treatment with ampicillin cannot be excluded. Will be given as per local standard of care.
16064136|NCT02424734|Drug|Aminoglycoside|Optional, will be given as per local standard of care.
16064137|NCT02424708|Drug|Reduced Glutathione 100mg|100mg GSH delivered intranasally, three times a day for 12 weeks, in 1 cc sterile saline using a syringe with a Mucosal Atomization Device (MAD) tip.
16064138|NCT02424708|Drug|Reduced Glutathione 200mg|200mg GSH delivered intranasally, three times a day for 12 weeks, in 1 cc sterile saline using a syringe with a Mucosal Atomization Device (MAD) tip.
16064139|NCT02424708|Drug|Placebo|Saline delivered intranasally, three times a day for 12 weeks, in 1 cc sterile saline using a syringe with a Mucosal Atomization Device (MAD) tip.
16064140|NCT02424695|Drug|Gabapentin Enacarbil (GEn)|"HORIZANT Extended-Release Tablets containing 600 mg of gabapentin enacarbil are white to off-white, with occasional black/grey spots, oval-shaped tablets debossed with GS LFG, supplied as:
~600 mg: NDC 53451-0101-1.The drug will be stored at 25°C (77°F) (excursions permitted 15° to 30°C (59° to 86°F)) Matching placebo will be provided by Xenoport Inc."
16064141|NCT02424695|Drug|Placebo|
16064142|NCT02424682|Other|No intervention|No intervention administered in this study
16064143|NCT02424669|Other|ALS Functional rating Scale-revised (ALS FRS-R)|
16064144|NCT02424669|Other|slow vital capacity|
16064145|NCT02424669|Other|Blood sample|
16064146|NCT02424669|Other|Cerebrospinal Fluid (CSF) sample|
16064147|NCT02424656|Procedure|MRI|EEG-functional MRI, structural MRI, diffusion MRI
16064148|NCT02424656|Procedure|TMS-EEG|Single pulse TMS combined with EEG, resting-state EEG, noise masking (auditory stimulation), electrical stimulation
16064149|NCT02424656|Procedure|FDG-PET|
16064150|NCT02424656|Other|Clinical scales|Evaluation of DOC: Coma recovery scale-Revised (CRS-R) and Rancho Los Amigos Scale (RLAS). Evaluation of function: Functional Independent Measure (FIMTM), and Early Functional Assessment (EFA).
16064151|NCT02424643|Behavioral|Monetary Incentive|$20 Amazon.com gift card
16064152|NCT02424643|Behavioral|Altruistic Incentive|"A preliminary statement of the importance of participation, and periodic inspirational messages throughout the length of the survey emphasizing the value to men's health by completing the survey"
16064153|NCT02424643|Behavioral|Dashboard Incentive|"A sample dashboard will compare data subjects enter in their survey to the data already collected from other men who have taken the survey. For the dashboard, men who complete the survey will be shown how their own reported data about certain topics compared to other men's data."
16064154|NCT02424630|Device|Ultrasound-guided ISB|ISB was performed by one anesthesiologist under ultrasound-guidance. The superior, middle, and inferior trunks of the brachial plexus were identified approximately 2 cm above the clavicle. A 50 mm 22-gauge needle was introduced percutaneously using an out-of-plane technique. The needle was placed beside each trunk in succession, and 2.5 mL ropivacaine was injected into each site. The total volume of ropivacaine used for ISB was 7.5 mL.
16064155|NCT02424630|Device|Arthroscopy-guided SSNB|At the end of the surgery, SSNB was performed under arthroscopic guidance by one shoulder arthroscopist. The suprascapular ligament was found using the lateral portal for visualization. The supraclavicular ligament was visualized at the end of the conoid ligament when the arthroscope was advanced following the coracoclavicular ligament. A 23-gauge spinal needle was introduced in a posteroanterior direction at a 20° angle percutaneously and 7 cm medial to the lateral margin of the acromion. Then, the needle was placed at the upper margin of the suprascapular ligament and advanced slightly under arthroscopy-guidance. After suctioning the saline from the portal, the injection material was administered according to the random assignment.
16064156|NCT02424630|Drug|Placebo|All the regional blocks in this study were performed using ropivacaine, except for arthroscopy-guided SSNB using placebo (10 mL normal saline)
16064157|NCT02424630|Drug|Ropivacaine|All the regional blocks in this study were performed using 10mL ropivacaine.
16064160|NCT02424591|Drug|Ketamine|Infusion at a rate of 10 mcg/kg/min
16064161|NCT02424591|Other|Placebo|Placebo IV
16064162|NCT02424578|Drug|Diclofenac Capsules low dose|
16064163|NCT02424578|Drug|Diclofenac Capsules high dose|
16064164|NCT02424565|Drug|IODEX® balm|2 ± 0.2 g of test balm will be applied topically in a crossover fashion at a gap of 3 days between the two product applications.
16064165|NCT02424565|Other|Placebo balm|2 ± 0.2 g of placebo balm will be applied topically in a crossover fashion at a gap of 3 days between the two product applications.
16064166|NCT02424552|Drug|Vitamin D3|Initial single dose 100000 IU, beginning from the second day 4000 IU/day for 24 weeks.
16064167|NCT02424552|Drug|Placebo|Filling material: lactose monohydrate, cellulose, magnesium stearate
16064168|NCT02424539|Drug|FFNS|FF as a aqueous suspension for intranasal inhalation with unit dose strength of 27.5 mcg per dose administered via a metered side-actuated nasal spray device.
16064169|NCT02424539|Other|Placebo|Placebo as a aqueous suspension to match the other study treatments minus the active component(s) for intranasal inhalation administered via a metered side-actuated nasal spray device.
16064170|NCT02424526|Other|home-based treadmill training|the child will walk on a pediatric treadmill with the help of the parent/caregiver and with weekly supervision of a physical therapist
16064171|NCT02424526|Device|Treadmill|
16064172|NCT02424513|Radiation|[89Zr]Df-IAB2M|A single intravenous infusion of 2.5 mCi of [89Zr]Df-IAB2M in a mass dose of 10 mg.
16064173|NCT02424500|Device|d-Nav|Insulin dosage is adjusted as required
16064174|NCT02424500|Device|Blood Glucose Monitoring System|Insulin dosage is adjusted as required
16064175|NCT02424487|Procedure|Intracuff pressure measurement in one-lung ventilation during thoracic surgery|
16064176|NCT02424474|Device|Genetic NIPT|Both tests are realized in a population of pregnant women (with and without in vitro fertilisation (IVF)) concomitantly at the same time.
16064177|NCT02424474|Biological|Regular serum screening|
16064178|NCT02424461|Drug|Ceftriaxone|1 injection 1 g per day for 2 days
16064179|NCT02424461|Drug|Ofloxacine|400 mg/jour (200 mg/ jour in case of renal failure) for seven days
16064180|NCT02424461|Drug|Ofloxacine|400 mg/jour (200 mg/ jour in case of renal failure) for 14 days
16064181|NCT02424461|Drug|Placebo of ofloxacine|Placebo of ofloxacine for 7 days
16064182|NCT02424448|Procedure|Biopsies, blood and urine samples|"Session 1: Biopsies will be taken from the main study lesion and up to 2 metastatic sites at 1 visit or over 3 visits. Both formalin fixed and snap frozen material will be collected. At the session (i.e. once over the potential maximum of 3 visits in a session) a urine sample, blood samples for circulating tumour cells (CTC) and an exploratory blood sample (processed to plasma) will be taken.
~Session 2: 7 days +/-3 following the last biopsy taken from Session 1, repeat biopsies from the same tumour sites will be obtained. In cases where this is not possible, it is acceptable to biopsy alternative lesions. As in Session 1 biopsies may be taken at 1 visit or over 3 visits and urine, CTC blood samples and an exploratory blood sample (processed to plasma) will be taken."
16064183|NCT02424435|Drug|Methylprednisolone|Oral tablets of methylprednisolone 8 mg. Subjects will receive a monthly prescription bottle of 25 tablets (standard quantity) and will self-administer 21 tablets over a 28-day dosing cycle.
16064184|NCT02424409|Behavioral|2: Intervention|"The corticoid treatment (Prednisolone or Prednisone) given from the ED for the first day if the patient is discharged at nighttime or during the weekend.
~A detailed prescription including 1) A written prescription of the corticosteroid treatment given orally for a total treatment length of 7 days 2) A written prescription describing the adaptation of the inhaled treatment 3) Peak expiratory flowmeter
~A written action plan with formalized recommendations for the patient
~A formal letter and recommendations to the general practitioner including information about the ED visit, and the necessity to program a follow up with regular consultations as well as to program spirometry evaluation for his patient.
~The ED doctor at discharge will explain all these documents orally
~Recommendations for an early contact with the general practitioner;
~Telephone call of the emergency department to the patient at day 7 +/-1 in order to ensure the link with the general practitioner."
16064185|NCT02424409|Behavioral|1: Control|patients without discharge protocol
16064186|NCT02424396|Drug|IL2|Induction period: repeated administration of low-dose IL-2 Maintenance period: treatment with IL-2
16064187|NCT02424396|Drug|Placebo|
16064188|NCT02424383|Device|PTA (Lutonix® 035 DCB Catheter)|"Percutaneous Transluminal Angioplasty (PTA) will involve the insertion of a catheter into one of the femoral arteries. Once the catheter is in place, a tiny balloon on the end of the catheter will be inflated to press against the narrowing (or blockage) in the artery to try to open the blockage, and allow more blood to flow through the artery. The balloon may need to be inflated several times in order for the narrowed area to open up sufficiently to improve the blood flow. The area will be viewed with specialized x-ray or other imaging devices to see if the artery has opened enough.
~The Lutonix® DCB through the blood vessel to the narrowed area to be treated."
16064189|NCT02424370|Procedure|TAVR|Percutaneous aortic valve replacement
16064190|NCT02424357|Drug|5%povidone iodine ophthalmic solution|one drop of 5% povidone iodine instilled into the conjunctival fornix.
16064191|NCT02424357|Drug|routine post-operative ophthalmic ointment|patient received a routine antibiotic/steroid ointment to operated eye at surgery completion
16064192|NCT02424344|Drug|Aclidinium/Formoterol|Aclidinium bromide/Formoterol fumarate FDC 400/12μg dry powder for oral inhalation twice daily via Genuair inhaler
16064193|NCT02424344|Drug|Placebo|Dose-matched placebo dry powder for oral inhalation twice daily via Genuair inhaler
16064194|NCT02424331|Other|Pursed Lips Breathing|Pursed Lips Breathing for six minutes.
16064195|NCT02424331|Other|Quiet Breathing|
16064196|NCT02424318|Drug|Topiramate|topiramate 25mg twice 1 week -> topiramate 50mg twice 7 weeks
16064197|NCT02424305|Drug|LEO 43204 gel 0.018%|
16064198|NCT02424305|Drug|LEO 43204 gel 0.1%|
16064199|NCT02424305|Drug|LEO 43204 gel 0.037%|
16064200|NCT02424292|Other|Physical activity|Physical activity in a personalised program.
16064201|NCT02424279|Procedure|Splanchnicectomy|
16064202|NCT02424266|Device|None invasive imaging of the tear film (AdOM)|White light tomography imaging
16064203|NCT02424253|Drug|ZPL-3893787|ZPL-3893787
16064204|NCT02424253|Drug|Placebo|Matched Placebo
16064205|NCT02424240|Other|IGF-1/IGFBP-3 ratio|IGF-1/IGFBP-3 ratio for the diagnosis of GHD Vs. IGF-1, IGFBP-3 and IGF-1 & IGFBP-3 combination
16064206|NCT02424214|Other|Artificial Oocyte activation|
16064207|NCT02424214|Drug|Ca Ionophore|
16064208|NCT02424214|Drug|Strontium Chloride|
16064209|NCT02424201|Drug|Misoprostol|experimental
16064210|NCT02424201|Drug|vitamin c|control
16064306|NCT02423603|Drug|AZD5363|Patients receive AZD5363/Placebo in an intermittent treatment schedule. Please see study arms for full information.
16064211|NCT02424188|Other|TRIIUMPH Intervention|Group and individual smoking cessation and weight management counseling, pharmacotherapy with varenicline or bupropion and nicotine replacement therapy, group exercise, and text messaging support
16064212|NCT02424175|Biological|Fecal Microbiota Transplantation|
16064213|NCT02424162|Device|+2.75 diopters multifocal intraocular lens|
16064214|NCT02424162|Device|+3.25 diopters multifocal intraocular lens|
16064215|NCT02424149|Drug|Phenazopyridine|
16064216|NCT02424136|Other|Questionnaire|5 minute questionnaire focused on symptoms of allergic disease
16064217|NCT02424136|Other|Peanut Skin prick test|Skin prick testing with peanut antigen, according to ASCIA Skin Prick testing manual
16064218|NCT02424136|Other|Fraction of exhaled nitric oxide|Measurement of exhaled nitric oxide, according to American Thoracic Society/ European Thoracic Society (ATS/ERS) standardised procedures (Not required for those age less than 6 years).
16064219|NCT02424136|Other|Spirometry|Measurement of lung flows/volumes, according to ATS/ERS standardised procedures (Not required for those age less than 6 years).
16064220|NCT02424136|Other|Serum Peanut and Ara h2 specific immunoglobulin E|Peanut and Ara h2 specific IgE antibodies
16064221|NCT02424136|Other|Collection of blood biomarker|Correlation of blood biomarker levels in patients with successful or unsuccessful peanut food challenge
16064222|NCT02424136|Other|Peanut food challenge|Open label peanut challenge conducted according to ASCIA's peanut challenge protocol and PRACTALL consensus report
16064223|NCT02424110|Procedure|argon beam coagulator ablation|The investigators plan to use argon beam coagulator ablation plus bipolar radiofrequency ablation in the argon beam coagulator ablation group.
16064224|NCT02424110|Procedure|bipolar radiofrequency ablation|The investigators only use bipolar radiofrequency ablation in the left and right atrial radiofrequency ablation.
16064225|NCT02424110|Device|argon beam coagulator （American，Valleylab）|Argon beam coagulator（American，Valleylab）will be used in the argon beam coagulator ablation group
16064226|NCT02424110|Device|bipolar radiofrequency (AtricuteTM)|The investigators plan to use bipolar radiofrequency(AtricuteTM) in the bipolar radiofrequency group
16064227|NCT02424097|Drug|CPP-ACP 5% sodium fluoride varnish & 900ppm fluoride paste|"MI Paste & MI Varnish- in-office:
~varnish application once every 3 months; at baseline, at the end of month 3, 6, and 9 (4 applications)
~- at-home: brushing with regular 1,100ppm F-toothpaste, 2x per day and MI Paste Plus, home application after brushing in the evening; 3-5 minutes with in-home application tray"
16064228|NCT02424097|Drug|1,100pm F-toothpaste and 0.5%NaF rinse|"Standard of care at-home:
~Crest tooth brushing 2x per day - (recommendation OTC Fluoride-rinse in the evening at home 1x per day)"
16064229|NCT02424084|Device|Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)|Extracorporeal Shock Wave Therapy
16064230|NCT02424071|Drug|Melatonin|
16064231|NCT02424071|Drug|placebo|
16064232|NCT02424058|Device|Spinal Mouse® measurement|The sagittal thoracic spinal curvature and mobility of all participants were assessed with Spinal Mouse® (Idiag, Fehraltorf, Switzerland) in standing position.
16064233|NCT02424058|Behavioral|Neck pain intensity measurement|The neck pain intensity of the patients was questioned by Visual Analogue Scale
16064234|NCT02424045|Drug|BCD chemotherapy (Bendamustine, Carboplatin, Dexamethasone)|All patients are scheduled to receive 2 cycles of three-weekly BCD. After 2 cycles of BCD, if the patients with complete remission (CR) or partial remission (PR) would be eligible for autologous stem cell transplantation (ASCT), stem cell collection after 3rd cycle of BCD and high dose chemotherapy and ASCT will be conducted. While ineligible patients to ASCT with non-progressive disease after 2 cycles of BCD, will be given 4 additional courses of the BCD regimen.
16064235|NCT02424032|Behavioral|"Exercise and connective tissue massage"|Cervical and scapulothoracic stabilization exercises with connective tissue massage were performed.The program was carried out for 12 sessions, 3 days/week in 4 weeks.
16064236|NCT02424032|Behavioral|"Exercise"|Cervical and scapulothoracic stabilization exercises were performed. The program was carried out for 12 sessions, 3 days/week in 4 weeks.
16064237|NCT02424019|Drug|ILUVIEN 0.19 MG|
16064238|NCT02424006|Device|RHCIII-MPC cornea|Patients will undergo surgery using conventional anterior lamellar keratoplasty technique: diseased cornea will be trephined to 350 um of corneal thickness and then a lamellar dissection will be created. Trephine diameter will be 7.5 mm. Alternatively a femtosecond laser may be used to create the dissection. A RHCIII-MPC cornea 350 um thick and equal or 0.25 mm larger diameter is placed and sutured. The sutures are superimposed and the implant and the sutures covered with a bandage contact lens. The sutures and bandage lens will be removed later after the initial healing period of 4 weeks or as determined by physician depending on the implant epithelial coverage.
16064239|NCT02424006|Device|Donor cornea|Patients will undergo surgery using conventional anterior lamellar keratoplasty technique: diseased cornea will be trephined to 350 um of corneal thickness and then a lamellar dissection will be created. Trephine diameter will be 7.5 mm. Alternatively a femtosecond laser may be used to create the dissection. A human donor cornea graft 350 um thick and 0.25 mm larger diameter is placed and sutured. The sutures will be removed in 3-6 months or as determined by physician.
16064240|NCT02423993|Behavioral|Education by structured programme|"Thе structured programme was developed in Endocrinology Research Centre. It is based on the following principles: education in group setting, using structured program; intensive insulin treatment using insulin pumps; self-adjustment of insulin dose and pump settings; intensive self-monitoring of blood glucose, including continuous glucose monitoring in real-time (CGM-RT); flexible physical activities and meals regimen (liberal diet, based on carbohydrates account using bread units; possible shifts of meals schedule and volume supported by appropriate treatment adjustment). Duration of education course - 8 days (35-37 hours); planned group volume is 7-10 patients."
16064241|NCT02423993|Device|CSII|The intensified insulin therapy by means of continuous subcutaneous insulin infusion will be provide by Medtronic insulin pumps: Paradigm MMT-712/715, Paradigm Real-Time MMT-722, Paradigm VEO MMT-754.
16064242|NCT02423993|Device|CGM-RT|"Continuous glucose monitoring (CGM) will be provide by means of Paradigm Real-Time MMT-722 and Paradigm VEO MMT-754 Medtronic sensor-augmented insulin pumps. For monitoring the Sof-Sensor and MiniLink transmitter (Medtronic) will be use. Each sensor will be use for 6 days. CGM will be use for self-monitoring of blood glucose on permanent basis (more than 6 days per week) within 4 month."
16064348|NCT02423265|Drug|Placebo|Matching placebo: up-titration after 1 week
16064243|NCT02423993|Procedure|Screening for Complications|To assess diabetic retinopathy a fundoscopy will be held. Diabetic nephropathy will be assessed by microalbuminuria screening, serum creatinine evaluation and calculation of CKD-EPI glomerular filtration rate. Diabetic neuropathy will be assessed by all kinds of sensitivity evaluation (vibrating, tactile, temperature).
16064244|NCT02423993|Procedure|Glycaemic control assessment|Glycemic control effectiveness changes will be assessed by measure of glycated hemoglobin (HbA1c). The frequency of blood glucose self-monitoring will be estimated by patient's diaries evaluation, individual glucometer data evaluation and insulin pump reports. Bolus calculator use and hypoglycemia nonsevere frequency will be assessed by reports received from insulin pumps.
16064245|NCT02423993|Procedure|QoL assessment|"For Quality of Life (QoL) assessment will be used the following validated questionnaires (in Russian):
~The Medical Outcomes Study 36-Item Short Form Health Survey - SF-36.
~The Audit of the Diabetes-Dependent Quality of Life - ADDQoL (С. Bradley et al, 1999, adjusted by Starostina E.G., 2003)."
16064246|NCT02423993|Procedure|Knowledge assessment|For the knowledge assessment of disease management the standard Questionnaire for patients with type 1 diabetes will be used. Maximum score equals 37 grades; the satisfactory level of knowledge is scored 27.
16064247|NCT02423980|Drug|Glucagon|
16064248|NCT02423967|Biological|Transplant uses frozen anonymous stool|The intervention is using frozen anonymous donor stool instead of fresh stool from family members for the fecal microbial transplant to treat recurrent CDI.
16064249|NCT02423967|Biological|Transplant uses fresh familial stool|The intervention is using fresh familial donor stool for the fecal microbial transplant to treat recurrent CDI
16064250|NCT02423954|Drug|Temsirolimus|
16064251|NCT02423954|Drug|Irinotecan|
16064252|NCT02423954|Drug|Irinotecan + capecitabine|
16064253|NCT02423954|Drug|nivolumab|
16064254|NCT02423941|Procedure|Retrogade reperfusion|Retrogade caval reperfusion of the donor liver during the transplant procedure with consequent arterial reperfusion.
16064255|NCT02423941|Procedure|Antegrade reperfusion|Antegrade conventional portal reperfusion of the donor liver during the transplant procedure with consequent arterial reperfusion.
16064256|NCT02423928|Biological|Dendritic cell based cryoimmunotherapy|Autologous dendritic cells will be obtained following leukapheresis and cytokine induction and will be injected into cryoablated prostate cancer tissue under ultrasound guidance.
16064257|NCT02423928|Drug|Cyclophosphamide|Low-dose cyclophosphamide will be given metronomically for the purpose of selective inhibition of T regulatory cells for 6 months following start of treatment.
16064258|NCT02423928|Drug|ipilimumab|The antibody and immune checkpoint inhibitor ipilimumab (Yervoy) will be given for the last 10 patients enrolled into the study in addition to cryoimmunotherapy and low-dose cyclophosphamide.
16064259|NCT02423915|Drug|Rituximab|375 mg/m2 by vein on Day -12 for for participants with CD20+ malignancies.
16064260|NCT02423915|Drug|Fludarabine|40 mg/m2 by vein on Days -8 to -5.
16064261|NCT02423915|Drug|Cyclophosphamide|50 mg/kg by vein on Day -8.
16064262|NCT02423915|Radiation|Total Body Radiation|2 Gy delivered on Day -4.
16064263|NCT02423915|Procedure|Fucosylated Regulatory T Cells|"Phase I: Participants treated at cell dose level 1: 1 x 10^6/kg Fucosylated T-reg cells on Day -1.
~Phase II: Participants treated at cell dose level 2: 1 x 10^7/kg Fucosylated T-reg cells on Day -1."
16064264|NCT02423915|Procedure|Cord Blood Infusions|Cord blood transplant, MRD, or MUD infused on Day 0.
16064265|NCT02423915|Drug|Mycophenolate mofetil|15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or mouth from Day -3 to Day +100 in the absence of GVHD.
16064266|NCT02423915|Drug|Sirolimus|12 mg by mouth load followed by 4 mg by mouth daily from Day -3 to Day +180 in the absence of GVHD.
16064267|NCT02423915|Procedure|Bone Marrow Aspiration|Bone marrow aspiration performed at 1, 3, 6, and 12 months after transplant to check status of disease.
16064268|NCT02423915|Drug|G-CSF|5 mcg/kg/day subcutaneously beginning on D+0, and continuing until absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
16064269|NCT02423915|Procedure|Non-Fucosylated Regulatory T Cells|"Phase I: Participants treated at cell dose level 1: 1 x 10^7/kg Non-Fucosylated T-reg cells on Day -1.
~Phase II: Participants treated at cell dose level 2: 1 x 10^7/kg Non-Fucosylated T-reg cells on Day -1."
16064270|NCT02423902|Biological|Ad-RTS-hIL-12|Approximately 1.0x10^12 viral particles (vp) per injection
16064271|NCT02423902|Drug|Veledimex|7 oral doses of veledimex
16064272|NCT02423889|Radiation|Radiotherapy|
16064276|NCT02423863|Biological|Hiltonol|"Wk 1 Days 1, 3 and 5: Poly-ICLC (Hiltonol®) 1 mg (0. 5 ml) IntraTumoral (priming treatment course). Weeks 2-25 Poly-ICLC (Hiltonol®) 1 mg (0.5 ml) IM twice a week with a 48-72 hour interval between the two injections, AND either:
~No additional immunotherapy OR
~ONLY ONE of the Anti-PD1 or anti-PDL-1 regimens will be administered, per manufacturer's dosing and clinical oncologist's discretion as follows: (Not to be Administered on the same day as Poly-ICLC [Hiltonol®]) Either Nivolumab, OR Pembrolizumab, OR Atezolizumab, OR Cemiplimab, OR Durvalumab"
16064277|NCT02423850|Device|3D Wound Assessment Monitor (WAM) camera|Three-dimensional wound measurement (2D area, 3D area, perimeter, volume) using 3D-WAM camera
16064278|NCT02423837|Drug|Rituximab, bendamustine|
16064279|NCT02423824|Biological|Liraglutide|Study participants will received the following study intervention in addition to 'standard of care' treatment: Adjunctive liraglutide will be initiated at 0.6 mg for the first 1 week, then increased to 1.2 mg with the option of increasing to 1.8 mg thereafter based on efficacy/tolerability (n=15 in each group). Liraglutide will be adjunctively administered to a conventional antidepressant, antipsychotic and mood stabilizing agent at guideline-concordant therapeutic plasma levels. Subjects will be randomized to receive liraglutide for a 4 week period. No major change in the pharmacological regimen will be permitted during the 4 week trial unless required for medical reasons.
16064280|NCT02423811|Dietary Supplement|Fursultiamine|Use of Fursultiamine in addition to CCRT
16064281|NCT02423798|Device|Glucose sensor (Enlite)|This is a postmarket, interventional, open-label, non-randomized, single center clinical research trial. The trial will adopt a prospective single-sample design using the Yellow Spring Instruments (YSI) plasma glucose reference sampling procedure in the clinic and selfmonitoring of blood glucose (SMBG) plasma glucose reference sampling procedure at home. The trial will consist of 6 visits to the investigational site: a visit for informed consent procedures (Visit 0), a screening visit (Visit 1), 3 study visits (Visit 2-4) and a final examination (Visit 5).
16064282|NCT02423772|Behavioral|Acceptance and Commitment Therapy + Mindfulness-Based Relapse Prevention + Treatment as Usual (TAU)|
16064283|NCT02423759|Drug|ciprofloxacin|500mg ciprofloxacin twice daily starting the day before biopsy and continued for 3 days after
16064284|NCT02423759|Drug|ciprofloxacin and gentamycine|standard chemoprophylaxis plus gentamicin 160mg intramuscular once just before the biopsy
16064285|NCT02423759|Drug|culture based chemoprophylaxis|Patients will receive antibiotic according to rectal swab culture at time of biopsy and then after for 3 days.
16064286|NCT02423746|Behavioral|Family Check Up Behavioral Parenting Training Program (BPT)|"The Family Check Up is an evidence-based Behavioral Parenting Training (BPT) program focused on harnessing parents' motivation to change and skills training.
~Intervention parents receive the initial assessment session followed by 3 Family Check-up Sessions within one month of baseline assessment followed by a post-intervention assessment. All sessions will be delivered in the patients' usual hearing clinics and will last between 60 and 90 minutes. One month post-intervention, participants will complete post-test measures repeating baseline measures, plus acceptability ratings of intervention."
16064287|NCT02423746|Behavioral|Behavioral Placebo|"The Behavioral Placebo sessions will consist of presentations of information about healthy lifestyles.
~Parents in the control group will receive an initial assessment session followed by three behavioral placebo sessions followed by a post-placebo-intervention assessment. All sessions will be delivered in the patients' usual hearing clinics and will last between 60 and 90 minutes. One month post-intervention, participants will complete post-test measures repeating baseline measures, plus acceptability ratings of intervention."
16064288|NCT02423733|Other|The Journal|"The Journal is a free internet based program for the self-management of depression (www.depression.org.nz) that was developed in New Zealand and capitalizes on the social marketing appeal of Sir John Kirwan, an ex All Black who has described his experiences of depression to help destigmatize mental illness. . The self-help program is based on the cognitive behavioral techniques of behavioral activation and problem solving which teaches patients the skills of problem solving and delivers an evidence based intervention which is personalized for their individual care."
16064289|NCT02423720|Behavioral|Audio-Based Mindfulness|Audio-based mindfulness tracks (MP3 format).
16064290|NCT02423707|Drug|ALK Alutard Birch and/or 5-grasses|"3 intralymphatic injections of 1000 SQ-U birch and/or grass allergen with 4 weeks interval.
~The substance used for the three intralymphatic injections is ALK-alutard SQ Betula verrucosa® and ALK-alutard SQ 5-grasses ® under ATC-code V01AA, V04CL and V07AB which is a depot formulation for subcutaneous use."
16064291|NCT02423707|Drug|ALK Diluent|This placebo group will receive 3 injections of 0.3% human albumin instead of active substance
16064292|NCT02423694|Device|electro-acupuncture|"8 acupoint: Guanyuan, Zigong (bilateral), Tianshu(bilateral), Sanyinjiao(bilateral), Hegu(bilateral), Taichong(bilateral), Baihui, Yintang.
~Every patient is supposed to have 36 times acupuncture treatment. 30 minutes per time. Baihui, Yintang, Zigong (bilateral), Tianshu (bilateral) are applied with electro-acupuncture device with dilatational wave, current frequency: 10/50Hz, intensity: 0.5~1.0 mA"
16064293|NCT02423694|Drug|escitalopram oxalate tablets|escitalopram oxalate tablet, once a day, 0.5 hour after breakfast, oral taken, 10mg, for 12 weeks
16064294|NCT02423681|Device|ThermoSmart|Heated humidification as first intention (HH1st) with ThermoSmart
16064295|NCT02423681|Device|Without ThermoSmart|ThermoSmart is switched off
16064296|NCT02423668|Procedure|50% Partial adjustment|Second eye refinement in the IOL power selection for the second eye using a theoretical 50% partial adjustment of the PE1.
16064297|NCT02423668|Procedure|No adjustment|IOL power selection for the second eye irrespective of first eye prediction error
16064298|NCT02423668|Procedure|Full adjustment|Second eye refinement in the IOL power selection for the second eye using a theoretical 100% partial adjustment of the PE1.
16064299|NCT02423655|Other|Algorithm for deferred dialysis intervention|Use combined indications to guide researchers to defer dialyzing progressive CKD patients. Asymptomatic patient will not start dialysis treatment until his eGFR becomes less than 5 ml/min/1.73m2. Or until 1. Patient's Kraemer index is >6 or with overt fluid overload after trying all conservative means（including appropriate medicines） 2. Patient's Subjective Global Assessment method (SGA) assessment is grade C 3. Patients have indications for emergency dialysis 4. Sever symptoms which cannot be relieved by conservative treatment
16064300|NCT02423655|Other|Algorithm for routine dialysis intervention|"Use combined indications to guide researchers to initiate dialysis in progressive CKD patients routinely. Researchers will start dialysis treatment for a patient when his eGFR reaches 7 ml/min/1.73m2 in asymptomatic patients.
~Or patients have indications below: 1. Patient's Kraemer index is >6 or with overt fluid overload after trying all conservative means（including appropriate medicines） 2. Patient's SGA assessment is grade C 3. Patients have indications for emergency dialysis 4. Sever symptoms which cannot be relieved by conservative treatment"
16064301|NCT02423642|Procedure|Continuous renal replacement therapy with regional citrate anticoagulation|"CRRT with anticoagulant : regional citrate anticoagulation
~Filter : AQUAMAX™ (Edwards Lifesciences)"
16064302|NCT02423642|Procedure|Continuous renal replacement therapy with no anticoagulation or heparin|CRRT with any anticoagulant : no anticoagulation or heparin Filter : AQUAMAX™ (Edwards Lifesciences)
16064303|NCT02423629|Device|Agili-C™ implantation procedure|Candidates for Agili-C™ implantation will be screened for possible inclusion in the trial. Candidates that are approved by the adjudication committee will be considered for study enrollment and then operated. Note: in case intra-operatively a medical condition is observed which is not aligned with the inclusion/exclusion criteria, the Subject will not be implanted with the Agili-C™ device and will not be considered enrolled in the study.
16064304|NCT02423616|Other|Healthy individuals|INSPIRATORY PRESSURE AND HAND GRIP FORCE CORRELATION
16064305|NCT02423603|Drug|Paclitaxel|Patient receive Once a week for three weeks - with one week off treatment
16065796|NCT02413255|Drug|TAK-020 Placebo|TAK-020 placebo-matching oral solution
16064307|NCT02423603|Drug|Placebo|Patients receive AZD5363/Placebo in an intermittent treatment schedule. Please see study arms for full information.
16064308|NCT02423590|Drug|Apatorsen (OGX-427)|Apatorsen (OGX-427) is a second generation antisense oligonucleotide designed to bind to Hsp27 mRNA
16064309|NCT02423590|Drug|Gemcitabine|"Gemcitabine is an anti-cancer (antineoplastic or cytotoxic) chemotherapy drug. Gemcitabine is classified as an antimetabolite"
16064310|NCT02423590|Drug|Carboplatin|"Carboplatin is an anticancer drug (antineoplastic or cytotoxic) chemotherapy drug. Carboplatin is classified as an alkylating agent."
16064311|NCT02423577|Drug|FF-3 dry powder|FF-3 dry powder administered by nasal inhalation
16064312|NCT02423577|Drug|Placebo|Placebo dry powder administered by nasal inhalation
16064313|NCT02423564|Dietary Supplement|Digesta Lac|
16064314|NCT02423564|Other|Placebo|
16064315|NCT02423551|Other|MRE|MRE consumption
16064316|NCT02423538|Drug|SHR0302|Oral tablets (1 mg, 5 mg, 10 mg)
16064317|NCT02423538|Drug|SHR0302 placebo comparator|Oral tablets (1 mg, 5 mg, 10 mg) (matching corresponding study medication)
16064318|NCT02423525|Drug|Afatinib|
16064319|NCT02423486|Device|Electromagnetic stimulation therapy (BIOCON-2000)|
16064320|NCT02423486|Device|Electromagnetic stimulation therapy with biofeedback|
16064321|NCT02423473|Procedure|Connective tissue graft|Periodontal surgical technique to treat gingival recessions
16064322|NCT02423473|Procedure|Composite resin restoration (Filtek Supreme - 3M)|Restorative procedure do treat tooth structure loss
16064323|NCT02423460|Other|Threonine|Threonine will be fed at various intake levels ranging from high to low in order to determine its requirement in healthy males and in patients with Crohn's disease and Ulcerative colitis.
16064324|NCT02423447|Device|Electro-Flo Intervention|An assigned respiratory therapist performed airway clearance on each participant with the Electro-Flo device following the 2012 CFF therapy guidelines
16064325|NCT02423447|Device|G5 Intervention|An assigned respiratory therapist performed airway clearance on each participant with the G5 device following the 2012 CFF therapy guidelines
16064326|NCT02423434|Other|Exposure: Corneal nerve fibre morphology by the CCM Procedure|"CCM is a non-invasive method for direct visualization of corneal nerve fibers. Previous research work has confirmed that corneal nerves status correlates with both small and large fibre damage as assessed by quantitative sensory testing and nerve conduction.
~In the current trial subjects will undergo a bilateral examination of the Bowman's layer of the cornea using the Rostock Cornea Module of the Heidelberg Tomograph III (Heidelberg Engineering, Smithfield RI, USA) to determine their corneal nerve fiber length, corneal nerve fiber density, corneal nerve branch density, and the tortuosity coefficient. Topical anaesthetic and a viscous gel medium will be applied to the eye, which will create a visual gel bridge between the cornea and the sterile single-use cap on the microscope objective lens. After the interface between the corneal epithelium and Bowman's layer is identified, batches of images will be taken and the most technically sound images will be identified and analyzed."
16064327|NCT02423421|Other|Faecal microbiota transplantation|Human Stool.
16064328|NCT02423408|Drug|TNX-201|TNX-201 capsule
16064329|NCT02423408|Drug|Placebo|Placebo capsule
16064330|NCT02423395|Drug|orphenadrine|Orphenadrine in muscle cramps in cirrhotic patients
16064331|NCT02423395|Drug|Placebo|calcium in muscle cramps in cirrhotic patients
16064332|NCT02423382|Procedure|Silicone oil removal|The patients in each group will receive the same procedure of silicone oil removal.
16064333|NCT02423369|Procedure|Cerebral near infrared spectroscopy|At the start of anesthesia on the patient's forehead two electrodes are attached the for continuous measurement of cerebral near infrared spectroscopy during surgery.
16064334|NCT02423369|Other|S-100B protein in serum|0,5-1 ml of blood from periferal site for determination of serum S-100B concentration.
16064335|NCT02423369|Other|NSE protein in serum|0,5-1 ml of blood from periferal site for determination of serum NSE concentration.
16064336|NCT02423356|Procedure|Echocardiogram|An echocardiogram uses sound waves to produce images of the heart. This commonly used test allows doctors to see how your the heart is beating and pumping blood. Doctors can use the images from an echocardiogram to identify various abnormalities in the heart muscle and valves.
16064337|NCT02423343|Drug|Galunisertib|Administered orally
16064338|NCT02423343|Drug|Nivolumab|Administered IV
16064339|NCT02423330|Device|Strattice-LIFT|Patients undergoing surgery for transsphincteric anal fistulas will undergo the Strattice-LIFT procedure. A standard LIFT procedure will be performed with the addition of Strattice placed into the intersphincteric space.
16064340|NCT02423317|Device|Intubation with Miller's blade|Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Miller's blade.
16064341|NCT02423317|Device|Intubation with Airtraq|Intubation is insertion of a hollow tube inside the trachea. It is done after laryngoscopy with Airtraq.
16064342|NCT02423304|Genetic|blood samples collected from all patients|blood samples collected from brachial pluxes
16064343|NCT02423291|Drug|Brentuximab Vedotin|Brentuximab vedotin, 1.8 mg/kg, administered via outpatient IV infusion on Day 1 of each 21-day cycle.
16064344|NCT02423278|Procedure|Radical Gastrectomy Plus D2 Lymphadenectomy|"This surgical procedure is performed by the same high-experienced surgical team as the control arm.
~All lymph nodes around stomach (station 1&2 LNs) must be removed to achieve a radical lymphadenectomy. Para-aortic lymph nodes should not be dissected even if a suspected lymph node metastasis is diagnosed from radiographic exams."
16064345|NCT02423278|Procedure|Radical Gastrectomy Plus D4 Lymphadenectomy|"This surgical procedure is also performed by the same high-experienced surgical team as the control arm.
~Lymph nodes around stomach (station 1&2 LNs) and para-aortic lymph nodes must be removed during the operation."
16064346|NCT02423278|Drug|S-1+Oxaliplatin|"A perioperative chemotherapy, known as SOX regimen, should be performed in each enrolled patient with three-cycle treatments followed after a pathological carcinoma diagnosis. After a radical operation (arm groups), additional five-cycle treatments of adjuvant chemotherapy (SOX regimen) would be performed, followed by follow-up program. The treatment bundles are listed as follows:
~S-1: 40~60mg bid，po, Day1~14 （S-1：BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid）
~Oxaliplatin: 130mg/m2，iv drip for 2h，Day1"
16064347|NCT02423265|Drug|Ranolazine|Ranolazine: 500 mg twice day, up-titrated after 1 week to 1000 mg twice a day
16064349|NCT02423252|Behavioral|Massage, Relaxation, Guided imagery and music listening.|In addition to standard care, patients in the intervention group will receive a 60 minutes individually delivered programme, administered once per day by a nurse (the researcher) for up to 5 days during staying in ICU. This session aims to induce relaxation and involves interpersonal support, touch/massage and through a headphone system relaxation and guided imagery exercises and music listening. Patients are provided a CD of the relaxation instructions, after their discharge, for own use
16064350|NCT02423252|Other|No Intervention|The control group will receive the standard care which includes the routine standard care provided by nurses, physiotherapists and intensivists or specialists (e.g. surgeons)
16064351|NCT02423239|Drug|Dexanabinol|Patients will receive dexanabinol given once a week, as a slow intravenous infusion (i.v.) over a 3 hour period
16064352|NCT02423239|Drug|Sorafenib|Patients will receive Sorafenib at a dose of 400 mg bid (oral administration)
16064353|NCT02423239|Drug|Nab-paclitaxel|Patients will receive Nab-paclitaxel at a dose of 125mg/m2 intravenous infusion
16064354|NCT02423239|Drug|Gemcitabine|Patients will receive Gemcitabine at a dose of 1000mg/m2 intravenous infusion
16064355|NCT02423226|Procedure|Computed tomography guided radioactive seeds implant|Computed tomography guided radioactive seeds implant were performed one week before chemotherapy.
16064356|NCT02423226|Drug|Systemic chemotherapy (FOLFIRI)|irinotecan 180mg/m2 d1,leucovorin 400mg/m2 d1, 5-fluorouracil 400mg/m2 iv, 2.4g/m2 civ 46h, repeated every 2 weeks
16064357|NCT02423200|Drug|VX-745|Orally-active P38 MAP kinase alpha-selective inhibitor
16064358|NCT02423187|Other|No Intervention|
16064359|NCT02423174|Procedure|Total Mesorectal Excision|Surgical intervention with the FMwand Surgical System
16064360|NCT02423174|Device|FMwand Surgical System|
16064361|NCT02423148|Drug|Indocyanine green (ICG)|
16064362|NCT02423148|Device|FluoSCOPE|
16064363|NCT02423135|Biological|Autologous blood transfusion|Volunteers make a blood donation and after 36 days of storage this blood is re-infused in the same volunteers.
16064364|NCT02423122|Drug|VX-745|Orally-Active Selective P45 MAP Kinase inhibitor
16064365|NCT02423109|Device|fanfilcon A|contact lens
16064366|NCT02423109|Device|enfilcon A|contact lens
16064367|NCT02423096|Drug|Risperidone|Patients with schizophrenia will be treated with antipsychotic drugs as routine care.
16064368|NCT02423083|Drug|Guanabenz|
16064370|NCT02423018|Drug|Pregabalin|In replacement of their morning 75mg pregabalin or placebo dose on Days 6 and 8, all participants will receive either a single dose of 300mg of pregabalin or placebo, in a randomized, double-blind, crossover manner. This is when steady state concentrations of pregabalin occur.
16064371|NCT02423018|Drug|Placebo|In replacement of their morning 75mg pregabalin or placebo dose on Days 6 and 8, all participants will receive either a single dose of 300mg of pregabalin or placebo, in a randomized, double-blind, crossover manner. This is when steady state concentrations of pregabalin occur.
16064372|NCT02423005|Device|Neurotech Vital Compact|Neuromuscular electrical stimulation of the pelvic floor via an arrangement of external electrodes held in place by a garment.
16064373|NCT02423005|Device|itouch Sure Pelvic Floor Exerciser|Vaginal probe with electrodes designed to deliver electrical stimulation to the pelvic floor muscles.
16064374|NCT02422979|Combination Product|PIT: 50 J/cm^2 for superficial lesions or 100 J/cm for interstitial lesions and Drug RM-1929: 160 mg/m^2|
16064375|NCT02422979|Combination Product|PIT: 50 J/cm^2 for superficial lesions or 100 J/cm for interstitial lesions and Drug RM-1929: 320 mg/m^2|
16064376|NCT02422979|Combination Product|PIT: 50 J/cm^2 for superficial lesions or 100 J/cm for interstitial lesions and Drug RM-1929: 640 mg/m^2|
16064377|NCT02422979|Combination Product|PIT: 75 J/cm^2 for superficial lesions or 150 J/cm for interstitial lesions and Drug RM-1929: 640mg/m^2|
16064378|NCT02422979|Combination Product|PIT: 100 J/cm^2 for superficial lesions or 200 J/cm for interstitial lesions and Drug RM-1929: 640mg/m^2|
16064379|NCT02422979|Combination Product|PIT: 50 J/cm^2 for superficial lesions or 100 J/cm for interstitial lesions and Drug RM-1929: 640mg/m^2|
16064380|NCT02422966|Drug|Paracetamol|
16064381|NCT02422966|Drug|Ibuprofen|
16064382|NCT02422953|Dietary Supplement|Wheat Soya Blend (WSB)|A monthly ration of 5 Kg of Wheat Soya Blend (WSB) will be given to pregnant women every month during pregnancy and lactating mothers for six months after giving birth
16064383|NCT02422953|Dietary Supplement|Wawa Mum|Children 6-23 months of age will receive a daily ration of 50 gram of Wawa Mum during study period
16064384|NCT02422953|Dietary Supplement|Micronutrient Powders (MNP)|Children 24-59 months of age will receive a sachet of Micronutrient Powders (MNP) in alternate days
16064385|NCT02422953|Behavioral|Behavior change and preventive health massages|Behavior change and preventive health massages will be delivered by lady health workers (LHWs) during monthly visits and in group meetings
16064386|NCT02422940|Drug|dalfampridine-ER 7.5 mg|
16064387|NCT02422940|Drug|dalfampridine-ER 10 mg|
16064388|NCT02422927|Dietary Supplement|Nutraceutical Combination|red yeast rice extract 200 mg (equivalent to 3 mg monacolins), policosanol 10 mg, berberine 500 mg, 0.2 mg folic acid, coenzyme Q10 2 mg, and astaxanthin 0.5 mg once daily
16064389|NCT02422927|Other|Standard of Care|low-cholesterol/low-saturated fat diet and regular aerobic physical activity schedule
16064390|NCT02422927|Other|Placebo|placebo
16064418|NCT02422732|Radiation|morphological and functional MRI (fMRI)|"The fMRI will consider on the acquisition of a 3D anatomical sequence in T1 high resolution in axial slices of 1mm with an acquisition time of 10 min and a T2 sequence and a Flair to allow UBO location."
16065899|NCT02412553|Other|Specific carbohydrate diet|
16064391|NCT02422914|Behavioral|Smoking cessation program TFC and activity tracker|Participants will receive a free TFC device and sufficient nicotine cartridges (8 mg/ml) to last the last of the procedure. Participants will be instructed to use the device ad libitum one week before their quit day (to be decided at the first contact) to familiarise themselves with its operation and on their designated quit day will stop smoking tobacco cigarettes and instead use the TFC exclusively for the next 11 weeks. The nicotine cartridges use will be monitored through the weekly diary and the monthly telephone. Lifestyle change will be monitored by the use of an activity tracker device (FitBit)
16064392|NCT02422914|Behavioral|Smoking cessation program TFC-free and activity tracker|"Participants will receive a free TFC device and a set of 10 ml flacons enough to complete the trial. Participants will be instructed to use the device ad libitum one week before their quit day (to be decided at the first contact) to familiarise themselves with its operation and on their designated quit day will stop smoking tobacco cigarettes and instead use the TFC exclusively for the next 11 weeks.
~The actual use of the device and smoking habits will be monitored through the weekly diary and the monthly telephone. Lifestyle change will be monitored by the use of an activity tracker device (FitBit)."
16064393|NCT02422914|Behavioral|Smoking cessation program and activity tracker|Participants undergo a motivational interview and low-intensity at distance counseling (the same counseling program of other groups) without any device.The actual smoking habits will be monitored through the weekly diary and the monthly telephone. Lifestyle change will be monitored by the use of an activity tracker device (FitBit).
16064394|NCT02422901|Drug|vitamin C|According to the character of an observational study no intervention other than the administration of Pascorbin® 7.5g (which is administered routinely in these cases) is provided.
16064395|NCT02422888|Drug|Ticagrelor|After a standard loading dose of 180 mg ticagrelor in the ambulance (before primary PCI), patients will receive a maintenance dose of ticagrelor 90 mg twice a day for 1 year.
16064396|NCT02422888|Drug|Prasugrel|After a standard loading dose of 180 mg ticagrelor in the ambulance (before primary PCI), patients will receive a single loading dose of prasugrel 60 mg (1 day after standard loading dose ticagrelor),followed by a maintenance dose of prasugrel 10 mg once a day for 1 year.
16064397|NCT02422862|Other|UC-TSM|"Upper cervical translatoric spinal mobilization: a 30 minutes treatment consisting of 30 series of translatoric mobilizations of the upper cervical spine with 10 rest between sets. For that purpose, the patient is positioned in supine, with the cervical spine in neutral position. The therapist place a hand dorsally at the level of the vertebral arch of C1 with the metacarpophalangeal and radial border of the index finger. The other hand is placed posteriorly under the occiput, with the shoulder positioned anteriorly on the patient's forehead. The mobilization force is directed dorsally from the shoulder until the therapist feel a marked resistance and then apply slightly more pressure in order to perform a stretching mobilization."
16064398|NCT02422849|Other|hospital specialist|
16064399|NCT02422849|Other|General Practitioner|
16064400|NCT02422836|Other|Three Product Anti-Aging Treatment Regimen|Cream Skin Cleanser RD04033B, twice daily, 8 weeks; Anti-aging Cream RD04034B, twice daily, 8 weeks; and Sunscreen SPF 50 RD04036, once daily, reapply as needed, 8 weeks
16064401|NCT02422823|Drug|Articaine|Injection of 1.8mL of 4% articaine with 1: 100,000 epinephrine in block the inferior alveolar nerve in patients with irreversible pulpitis of mandibular molar in 40 patients
16064402|NCT02422823|Drug|Articaine|Injection of 3.6mL of 4% articaine with 1: 100,000 epinephrine in block the inferior alveolar nerve in patients with irreversible pulpitis of mandibular molar in 40 patients
16064403|NCT02422823|Drug|Epinephrine|
16064407|NCT02422784|Dietary Supplement|Rooibos Iced-Tea (Control)|Participants will consume 240 mL of Rooibos iced-tea daily for 6 weeks. The iced-tea beverage will not contain any added sugar or artificial sweeteners. Beverages will be prepared fresh weekly and picked up by participants during their weekly study visits.
16064408|NCT02422784|Dietary Supplement|Rooibos Tea - Vitamin D3|Participants will consume 240 mL of Rooibos iced-tea fortified with 1000 IU of water soluable Vitamin D3 daily for 6 weeks. The iced-tea beverage will not contain any added sugar or artificial sweeteners. Beverages will be prepared fresh weekly and picked up by participants during their weekly study visits.
16064409|NCT02422784|Dietary Supplement|Rooibos Tea- Vitamin D3 & Calcium|Participants will consume 240 mL of Rooibos iced-tea fortified with 1000 IU of water soluable Vitamin D3 and 360 mg of Calicum daily for 6 weeks. The iced-tea beverage will not contain any added sugar or artificial sweeteners. Beverages will be prepared fresh weekly and picked up by participants during their weekly study visits.
16064410|NCT02422771|Other|FIFA 11+ warm-up|A sequence of 15 exercises performed before soccer practices and games. The exercises include strength, agility, balance and motor control components and take about 15-20 minutes to perform. The intervention replaces any previous warm-up the athletes may have done.
16064411|NCT02422758|Device|3M™ Bair Hugger™ Preoperative & Outpatient Care Blanket|3M™ Bair Hugger™Preoperative & Outpatient Care Blanket will cover the whole body. Patients will be prewarmed for 20 minutes with forced air warming system. Unit will be at average power.
16064412|NCT02422758|Other|Passive Prewarming|
16064413|NCT02422745|Dietary Supplement|Cocoa extract|2 capsules each day containing a total of 500 mg cocoa flavanols, including 80 mg (-)-epicatechin, and 50 mg theobromine
16064414|NCT02422745|Dietary Supplement|Multivitamin|Multivitamin
16064415|NCT02422745|Dietary Supplement|Cocoa extract placebo|Cocoa extract placebo
16064416|NCT02422745|Dietary Supplement|Multivitamin placebo|Multivitamin placebo
16064417|NCT02422732|Other|Neuropsychological assessments|"IQ (WISC-IV)
~Reading tests (reading accuracy, reading speed, reading comprehension and strategy):
~Alouette, Lobrot, Odedys tests. Visuo-spatial skill (JLO, Thurston, CORSI tests) Attention (CPT 2, CBCL) Receptive oral language (EVIP)"
16064465|NCT02422446|Drug|Icosapent ethyl|icosapent ethyl is eicosapentaenoic acid, an omega-3 fatty acid that naturally occurs in fish
16064419|NCT02422732|Genetic|genetic analysis|Blood collection in 3 tubes (2 PAXgen® and 1 EDTA) and analysis to study the NF1 gene deletion.
16064420|NCT02422719|Drug|Radotinib|Radotinib 400mg bid
16064421|NCT02422706|Drug|Nitazoxanide|Nitazoxanide based treatment regimens as a new treatment regimens for helicobacter pylori infection
16064422|NCT02422706|Drug|Metronidazole(MTZ)|Metronidazole 500 mg twice daily
16064423|NCT02422706|Drug|Omeprazole|Omeprazole 20 twice daily
16064424|NCT02422706|Drug|Clarithromycin|KLacid twice daily
16064425|NCT02422706|Drug|Levofloxacin|Tavanic. Tavacin
16064426|NCT02422706|Drug|Doxicycline|Vibramycin 100 mg twice daily
16064427|NCT02422693|Other|Aquatic Exercises|Exercises performed in the water.
16064428|NCT02422693|Other|Deep-water running|It is a non-impact form of running executed in place in (higher than 2 meters) the water wearing a flotation belt. Heart rate is controlled by heart rate watch
16064429|NCT02422680|Procedure|No intervention, purely observational.|No intervention is made other than following existing guidelines for colonoscopy. Further treatment and/or renewed colonoscopy in case of positive findings follows existing guidelines. The group is used only used to collect quality assurance data.
16064430|NCT02422667|Other|Patient Registry|Orthopedic Data Registry
16064431|NCT02422654|Drug|eliglustat|"Pharmaceutical form:liquid formulation
~Route of administration: oral without ingestion"
16064432|NCT02422641|Drug|High-dose Methotrexate (8 gm/m2; HD-MTX)|Enrolled patients will undergo treatment with HD-MTX (8 g/m2) as per current standard practice on an every 2 week schedule until disease progression or death from any cause. Treatment will be performed according to standard clinical practice. Surveillance imaging with or without cytologic evaluation will be performed as per standard clinical practice after every 2 cycles (~28 days). Treatment will continue until there is unequivocal evidence of clinical or radiographic CNS or systemic disease progression, death from any cause, or intolerance.
16064433|NCT02422615|Drug|Ribociclib|Ribociclib 600mg daily oral (days 1 to 21 in a 28-day Cycle)
16064434|NCT02422615|Drug|fulvestrant|Fulvestrant 500mg i.m. injections every 28 days (Cycle n Day 1) with 1 additional dose on Day 15 of Cycle 1
16064435|NCT02422615|Drug|Ribociclib placebo|Ribociclib placebo 600mg daily oral (days 1 to 21 in a 28-day Cycle)
16064436|NCT02422602|Drug|Xarelto|Taking conventional charge
16064437|NCT02422602|Other|Experimental: Personalized information intervention|
16064438|NCT02422589|Drug|ceritinib|
16064439|NCT02422589|Drug|warfarin|
16064440|NCT02422589|Drug|midazolam|
16064441|NCT02422576|Other|cinnamon extract|acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)
16064442|NCT02422576|Other|lemon extract|acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)
16064443|NCT02422576|Other|lemon extract plus eucalyptus extract|acute exposure to natural ingredient during physiological parameters recording (deglutition or cortical activity)
16064444|NCT02422576|Other|Thicken Up clear: TUC|
16064445|NCT02422563|Procedure|hysterectomy|radical hysterectomy
16064446|NCT02422563|Radiation|Radiation|
16064447|NCT02422563|Drug|Cisplatin|
16064448|NCT02422563|Drug|Paclitaxel|
16064449|NCT02422563|Drug|Carboplatin|
16064450|NCT02422563|Drug|Ifosfamide|
16064452|NCT02422537|Dietary Supplement|Unmodified wheat bran|
16064453|NCT02422537|Dietary Supplement|Wheat bran with reduced particle size|
16064454|NCT02422537|Dietary Supplement|Destarched pericarp-enriched wheat bran|
16064455|NCT02422537|Dietary Supplement|No wheat bran fraction|
16064457|NCT02422511|Genetic|Genomic sequencing|Both sick and healthy infants randomized to receive genomic sequencing will receive a 'Genomic Newborn Sequencing Report' (GNSR) which will include pathogenic or likely pathogenic variants identified in genes associated with childhood-onset disease.
16064458|NCT02422511|Other|Family history report|Participants from all arms of the study will have a family history taken by a study genetic counselor. Information collected through the family history will be summarized in a family history report that will be reviewed with all participants.
16064459|NCT02422498|Radiation|external beam radiation therapy|Radiation therapy to the target tumor will be delivered with external beam radiation therapy. In metastatic cases where the intent is palliative, the dose of radiation will be 3750 cGy delivered in 15 daily fractions, 4-5 days a week. In locoregionally recurrent cases where the intent is to enhance locoregional control, the dose of radiation will be 5000 cGy delivered in 25 fractions, 4-5 days a week plus an optional 10-14 Gy boost to areas of gross tumor.
16064460|NCT02422498|Drug|cisplatin|Cisplatin treatment should be initiated following study registration. The dose of cisplatin is established as 25 mg/m^2 ivpb once a week (+ 3 days) for 1-2 weeks prior to radiation. The length of one cycle of Cisplatin is 21 days.
16064461|NCT02422498|Procedure|Biopsy of Target Tumor|Biopsy of the tumor to be irradiated will be performed. Fresh tissue specimens will be sent to the laboratory for performance of the MSK-HRR Assay.
16064462|NCT02422485|Drug|Salsalate|Salsalate is a non-acetylated dimer of salicylic acid, and is classified as a NSAID. The chemical name of salsalate is 2-hydroxy-benzoic acid, 2-carboxyphenyl ester. Salsalate has a molecular weight (MW) of 258.226 Da and a molecular formula of C14H10O5.
16064463|NCT02422472|Device|Ultrasound guided peripheral IV placement|Accucath™ 20 Gax 5.7cm catheter
16064464|NCT02422459|Behavioral|COMMENCE|ChrOnic pain self-ManageMent support with pain science Education and exerCisE (COMMENCE) consists of two visits with a physiotherapist per week over six weeks. One of the two visits is in a group setting, where the emphasis is on pain neurophysiology education and provision of self-management strategies. The second visit each week is an individualized, one-to-one session in which the focus is on providing support for implementing self-management strategies and developing of an individualized, goal-oriented exercise program.
16064466|NCT02422433|Device|OFDI Capsule Marking|Marking and imaging of the esophagus using the OFDI Capsule and system.
16064467|NCT02422420|Behavioral|Financial Incentives|Use of financial incentives to promote health behaviors.
16064468|NCT02422407|Procedure|Biopsy|Salivary Gland
16064469|NCT02422394|Drug|Eltrombopag|
16064470|NCT02422381|Drug|MK-3475|Investigational drug.
16064471|NCT02422381|Drug|Gemcitabine|Standard care drug.
16064472|NCT02422368|Drug|Methylprednisolone + ASTED|"ASTED tablet: Twice daily for 6 months
~Methylprednisolone:
~Methylprednisolone tablet of 50 and 5 mg, company….) 1mg/kg for the first 2 weeks, 0.8mg/kg for 2 weeks, 0.7 mg/kg for 2 weeks, and then tapering off the methylprednisolone in 6 weeks (total duration of 12 weeks) by 8-10 mg per week. For example, a patient with 75 kg weight will receive 75 mg for 2 weeks, 60 mg for 2 weeks, 52.5 mg for 2 weeks, and then decreasing by 8-10 mg per week for 6 weeks. The dose regiment will be written and handed to the patient on the first visit and will be monitored during the follow ups."
16064473|NCT02422368|Drug|Methylprednisolone +Placebo|"Placebo: twice daily
~Methylprednisolone:
~Methylprednisolone tablet of 50 and 5 mg, company….) 1mg/kg for the first 2 weeks, 0.8mg/kg for 2 weeks, 0.7 mg/kg for 2 weeks, and then tapering off the methylprednisolone in 6 weeks (total duration of 12 weeks) by 8-10 mg per week. For example, a patient with 75 kg weight will receive 75 mg for 2 weeks, 60 mg for 2 weeks, 52.5 mg for 2 weeks, and then decreasing by 8-10 mg per week for 6 weeks. The dose regiment will be written and handed to the patient on the first visit and will be monitored during the follow ups."
16064474|NCT02422355|Device|FNS|Surgical intervention using the FNS
16064475|NCT02422342|Device|Pulse Oximeter CMS50FW (Contec Medical)|"The patients will be wearing the pulse oximeter during the test period (20-30 minutes).
~The data from the oximeter will be sent by Bluetooth to the mobile application"
16064476|NCT02422329|Behavioral|Questionnaires|Participants complete questionnaires at baseline and after intervention.
16064477|NCT02422329|Behavioral|Video|Participants watch a 3-minute educational video describing symptoms of constipation and importance of regular bowel movements.
16064478|NCT02422329|Behavioral|Fact Sheet|Participants read educational material describing symptoms of constipation and importance of regular bowel movements.
16064479|NCT02422316|Other|Non-contrast Cardiac CT scan|
16064480|NCT02422303|Drug|ketamine|Ketamine 0.5mg/kg will be given intravenously to group A at induction of general anesthesia.
16064481|NCT02422290|Drug|Ketamine|Single infusion of IV Ketamine, 0.5mg/kg
16064482|NCT02422277|Device|LI-ESWT group|"The patients in this arm will be subjected to Penile LI-SWT in the following parameters: 6 to 12 sessions with 1500 shocks per session. Each session will comprise the application of 300 shock waves (energy intensity of 0.09 mJ/mm2) to each of five different sites on the penis: three along the penile shaft and two at the crura with Frequency: 4 HZ. Energy level: 8 mJ/mm2. Rate: 120 shocks per minute.
~-Intervals: 2 treatment sessions per week for 3 weeks, then 3-weeks no-treatment interval, then 3-weeks treatment period of 2 treatment sessions per week."
16064483|NCT02422277|Drug|PDE-5 inhibitors group|The patient in this arm will receive 50 mg of phosphodiesterase-5 inhibitors, oral intake once daily for 6 monthes.
16064484|NCT02422264|Biological|Infanrix hexa|• All subjects will receive Infanrix hexa at 2 and 4, at 3 and 5, at 2, 4 and 6 months or at 2, 3 and 4 months, depending on the immunisation schedule of the country. Infanrix hexa is administered intramuscularly to the right thigh.
16064485|NCT02422264|Drug|Prevnar13|• All subjects will receive Infanrix hexa co-administered with Prevenar13* at 2 and 4, at 3 and 5, at 2, 4 and 6 months or at 2, 3 and 4 months, depending on the immunisation schedule of the country. *In some countries/regions with an Infanrix hexa 3-dose vaccination schedule, Prevenar 13 could be administered as 2-doses or 3-doses primary vaccination schedule (according to the routine national immunisation schedule). Prevnar13 is administered intramuscularly to the left thigh.
16064486|NCT02422251|Device|Mobile high congruency bearing (Columbus)|Columbus high congruency bearing on a rotating platform tibia.
16064487|NCT02422251|Device|Fixed high congruency bearing (Columbus)|Columbus high congruency bearing on a fixed platform tibia.
16064488|NCT02422251|Device|Fixed high congruency bearing (Columbus)|Columbus deep dish bearing on a fixed platform tibia.
16064489|NCT02422225|Device|Eldith DC-STIMULATOR|"Transcranical direct current stimulator (Neuroconn GmbH, Ilmenau, Germany) approved by Conformity European as safe treatment device for stroke patients
~tDCS intervention]
~Intensity: 1.5mA for 20min Device: Neuroconn GmbH, Ilmenau, Germany
~Stimulation site <Experimental group>
~Anode-Anode dual stimulation group Anode: affected pharyngeal motor cortex / Cathode: affected supraorbit Anode: non-affected pharyngeal motor cortex / Cathode: non-affected supraorbit
~Anode-Cathode dual stimulation group Anode: affected pharyngeal motor cortex Cathode: non-affected pharyngeal motor cortex
~Single stimulation group Anode: affected pharyngeal motor cortex Cathode: non-affected supraorbit <Control group> Sham stimulation"
16064490|NCT02422225|Device|Sham Eldith DC-STIMULATOR|
16064491|NCT02422212|Other|patients eat a mixed solid meal|The three groups were given an indirect calorimetry examination to measure their resting metabolic rate (RMR), respiratory exchange rate (RER) and DIT. The patients collected urine during 24 hours for urinary nitrogen analysis. Immediately after the RMR measurement, patients received a solid mixed meal (270 kcal, with 62% carbohydrate, 12% protein and 26% lipid). Ten minutes after beginning this food intake, postprandial (PP) energy expenditure measurements were taken in the following sequences (in minutes): 10-20, 20-30, 30-40, 60-70, 70-80, 80-90, 110-120, 120- 130, 130-140, 160-170 and 170-180.The DIT was calculated for each time interval.
16064492|NCT02422199|Drug|pyrotinib|
16064493|NCT02422199|Drug|Lapatinib|
16064494|NCT02422199|Drug|capecitabine|
16064495|NCT02422186|Drug|Esketamine|All participants will start with first dose (Day 1 as 28 milligram [mg]); second dose (Day 4) is either 28 or 56 mg. All subsequent doses may be 28, 56 or 84 mg. After the first dose, all dosing decisions are determined by the investigator based on efficacy and tolerability.
16064496|NCT02422186|Drug|Placebo|Participants will self-administer matching placebo, intranasally, twice per week for 4-weeks as a flexible dose regimen in the Double-Blind Induction Phase.
16064497|NCT02422186|Drug|Duloxetine (Oral Antidepressant)|Duloxetine could be selected as the oral antidepressant medication by the investigator based on review of Massachusetts General Hospital -Antidepressant Treatment Response Questionnaire (MGH-ATRQ) and relevant prior antidepressant medication information. The minimum therapeutic dose is 60 milligram per day (mg/day).
16065900|NCT02412553|Other|Elemental diet|
16064498|NCT02422186|Drug|Escitalopram (Oral Antidepressant)|Escitalopram could be selected as the oral antidepressant medication by the investigator based on review of MGH-ATRQ and relevant prior antidepressant medication information. Escitalopram will be given at a dose of 10 mg/day throughout the Double-Blind Induction Phase. This dose (10 mg/day) is the also the minimum therapeutic dose.
16064499|NCT02422186|Drug|Sertraline (Oral Antidepressant)|Sertraline could be selected as the oral antidepressant medication by the investigator based on review of MGH-ATRQ and relevant prior antidepressant medication information. Sertraline may be titrated up to a dose of 150 mg/day, but if not tolerated the dose can be reduced to the minimum therapeutic dose of 50 mg/day.
16064500|NCT02422186|Drug|Venlafaxine Extended Release (XR) (New Antidepressant)|Venlafaxine Extended Release could be selected as the oral antidepressant medication by the investigator based on review of MGH-ATRQ and relevant prior antidepressant medication information. Venlafaxine Extended Release may be titrated up to a dose of 150 mg/day, but if not tolerated the dose can be reduced to the minimum therapeutic dose of 75 mg/day.
16064501|NCT02422173|Device|Anodal transcranial direct current stimulation|The active electrode is placed on the affected hemisphere
16064502|NCT02422173|Device|Cathodal transcranial direct current stimulation|The active electrode is placed on the unaffected hemisphere
16064503|NCT02422173|Device|Bilateral transcranial direct current stimulation|The cathode and anode is positioned as active electrodes on the unaffected and affected hemisphere,respectively.
16064504|NCT02422173|Device|Sham transcranial direct current stimulation|Placebo stimulation, with emission current by only 30 seconds
16064505|NCT02422160|Other|No interventions are planned|No interventions are planned
16064506|NCT02422147|Procedure|Ablation of PCL|All procedures are standard of care and will be undertaken using a curvilinear echoendoscope. The cyst will be punctured using a 22G needle and after subtotal evacuation of the cyst, injection is performed with a volume of alcohol that is equal to the quantity aspirated, and the cyst will be lavaged for 3 to 5 minutes. The injected ethanol will then be evacuated at the end of lavage, leaving just enough fluid to outline the cavity. A second ablative agent such as paclitaxel is then injected and left in the cyst cavity. At the completion of the procedure, the needle will be removed from the cyst cavity.
16064507|NCT02422134|Other|Cytokine group|Testing the efficacy of adding Cytokine to embryo transfer medium
16064508|NCT02422121|Drug|RNS60|
16064509|NCT02422121|Drug|Placebo|
16064510|NCT02422108|Drug|Denosumab|
16064511|NCT02422095|Procedure|Endoscopy-based (EUS-guided) interventions for pancreatic fluid collections|Data included are patient demographics, symptoms, disease severity, procedural indications, details of the pancreatic fluid collection on cross-sectional imaging/EUS, review of laboratory results/imaging, details of interventions, clinical response to intervention, adverse events from interventions and pancreatitis/pancreatic fluid collections, response to treatment including any recurrent hospital admissions, recurrence of pancreatic fluid collections, need for repeat interventions, details of pancreatic duct integrity (e.g. presence of disconnected pancreatic duct syndrome), and clinical status at follow-up.
16064512|NCT02422095|Procedure|EUS of pancreatic cysts|Data included are patient demographics (age, gender, race), symptoms at presentation, imaging modality performed to detect the cyst, cyst features on EUS, technical details of EUS-guided sampling, results of cyst fluid analysis, final diagnosis, any follow up and repeat examinations and details of any treatment performed.
16064513|NCT02422082|Dietary Supplement|L. reuteri|Dietary supplementation with L. reuteri twice daily for 12 months
16064514|NCT02422082|Dietary Supplement|Placebo|Dietary supplementation with placebo twice daily for 12 months
16064515|NCT02422056|Drug|Tranexamic Acid|Tranexamic acid bolus of 10 mg / kg at the beginning of palatoplasty, followed by infusion of 1 mg / kg / h until the end of the procedure
16064516|NCT02422056|Drug|Saline|Infusion of saline in the same rate used for the intervention group
16064517|NCT02422043|Other|Questionnaires and audio-tape interviews|therapeutic patient education programs (TPE) to type 1 diabetic adolescents are designed to make the teenager to self manage their disease and their treatment. Based on Bandura's social cognitive theory, effects of educational activities for TPE should lead to the strengthening of self-efficacy
16064518|NCT02422030|Drug|Lipitor Tab. 40mg|
16064519|NCT02422030|Drug|Trilipix 135mg|
16064520|NCT02422017|Drug|Timolol|Patients will receive one drop of timolol every 6cm ² every other day for twelve weeks applied on the ulcer of interest
16064521|NCT02422017|Other|Local care treatment|Local care treatment with dressing compression in accordance with standards applied every other day
16064522|NCT02422004|Other|Range of motion|25 range of motion exercises of the ankle, 5 times per day.
16064523|NCT02422004|Other|Delayed weight-bearing|No weight-bearing during the first six weeks, and partial weight-bearing during the two following weeks
16064524|NCT02421991|Behavioral|Telephone Delivered Intervention|
16064525|NCT02421965|Behavioral|FOCUS (Smartphone Application)|Participants in the FOCUS group will be given a study smartphone device with FOCUS application and trained by the mHealth support specialist on how to use the functions of the smartphone (i.e. using a touchscreen, call, text) and different features of the FOCUS intervention.
16064526|NCT02421965|Behavioral|WRAP (Wellness Recovery Action Planning)|Participants allocated to the WRAP group will be provided all other materials (i.e. WRAP binder, handouts) in their first session and will meet weekly in groups with trained facilitators.
16064527|NCT02421939|Drug|gilteritinib|tablet, oral
16064528|NCT02421939|Drug|LoDAC (Low Dose Cytarabine)|subcutaneous (SC) or intravenous (IV) injection
16064529|NCT02421939|Drug|Azacitidine|SC or IV injection
16064530|NCT02421939|Drug|MEC (Mitoxantrone, Etoposide, Cytarabine)|IV injection
16064531|NCT02421939|Drug|FLAG-IDA (Granulocyte-Colony Stimulating Factor (G-CSF), Fludarabine, Cytarabine, Idarubicin)|SC (G-CSF) and IV (Fludarabine, Cytarabine, Idarubicin) injection
16064556|NCT02421666|Behavioral|PNMI|Eligible patients received patient navigator led plus mobile phone text messaging intervention (PNMI) or standard care. Bilingually trained patient navigators were recruited from our existing patient navigator training network, received intensive training on HBV prevention, diagnosis and treatment management, and served as a liaison with respective clinical partners. The PNMI intervention offered three education sessions on HBV management and weekly CHB patient-designed educational phone-based text messages for five weeks.
16066061|NCT02411448|Drug|Ramucirumab|Administered IV.
16064532|NCT02421926|Drug|IDEAL-E observation (investigators choice of imatinib, nilotinib, dasatinib, radotinib)|After the end of follow-up period of IDEAL study, subjects who agree with this extension study (IDEAL-E) will be enrolled and be followed up for additional 4 years to evaluate the duration of treatment response, disease progression, and survival status. Subjects who will be enrolled in this prospective observational study will be treated with drugs - imatinib 300-600mg / nilotinib 600mg / dasatinib 100mg / radotinib 800mg - which has been chosen by the each investigator according to the drug compliance and overall response. The drug choice will be at the discretion of each investigator, and the overall adverse event / molecular response will be monitored every 6 months in this prospective observational study.
16064533|NCT02421913|Drug|S(+)-Ketamine|S(+)-Ketamine 0,3mg/kg/hr intraoperative
16064534|NCT02421900|Other|radio-frequency catheter ablation of atrial fibrillation|radio-frequency catheter ablation of atrial fibrillation
16064535|NCT02421887|Drug|Antioxidant Supplement|An antioxidant combination including Vitamin C, Vitamin E, folic acid, selenium, zinc, and L-carnitine
16064536|NCT02421887|Other|Placebo|Placebo
16064537|NCT02421874|Behavioral|Wraparound Team Monitoring System electronic health record|Wraparound Team Monitoring System (Wrap-TMS) is a web-based, electronic behavioral health information system (EBHIS) for the most widely implemented care coordination model in children's behavioral health, the wraparound process
16064538|NCT02421874|Behavioral|Education about fidelity maintenance and monitoring|As an active comparator, we will educate practitioners randomized to the control condition about the importance of maintaining fidelity and monitoring fidelity and progress via a 3 hour training.
16064539|NCT02421861|Behavioral|Anxiety Management in the ICU|"The AM intervention is based on a Cognitive-Behavioral Therapy (CBT) approach, empirically supported in other settings, though we do not know whether this approach will be effective for ICU patients. It will offer all participants core aspects of CBT including: (1) establish rapport/therapeutic alliance; (2) anxiety psychoeducation; (3) normalization of difficulties; (4) establishment of a sense of hope; (5) reflective listening; (6) supportive statements; (7) exposure to anxious thoughts/feelings; (8) directive statements; and (9) provision of coping strategies. It will consist of modules that include the aforementioned core aspects and optional modules based on each participant's anxiety experience and preference."
16064540|NCT02421861|Other|Usual Care (UC)|The UC group will receive usual care as per the Harborview Medical Center usual care standard. Because this is an effectiveness trial, treatment decisions for UC participants will be left to the discretion of the primary provider and/or primary medical team and may or may not include: (1) referral to rehab psychology C&L service; (2) referral to psychiatry C&L service; or (3) pharmacologic management.
16064541|NCT02421835|Dietary Supplement|Olive leaf extract|132 mg of oleuropein per day suspended in olive leaf extract 700 mg
16064542|NCT02421835|Dietary Supplement|Placebo|700 mg Maltodextrin per day
16064543|NCT02421822|Other|Fitwits office tool and games|Physician-led narration of Fitwits office tool during well child and subsequent visits over one year with distribution of Fitwits games during first visit.
16064544|NCT02421770|Other|Chamaemelum nobile 2%|"Experimental Chamaemelum Nobile 2% gel Active During the 6-week double-blind phase, all patients will be randomly assigned to receive Chamaemelum Nobile 2% gel Active or its vehicle twice daily with occlusion on the affected are"
16064545|NCT02421770|Other|placebo|
16064546|NCT02421757|Device|Fischell Transcutaneous Magnetic Stimulation Pain Treatment Device|Transcutaneous Magnetic Stimulation
16064547|NCT02421757|Device|Placebo|The placebo Transcutaneous device
16064548|NCT02421744|Behavioral|Task Oriented Circuit Training|TOCT includes six different workstations in which subjects exercise for 5 minutes in each one (3 minutes of exercise and 2 minutes of rest). During each session, subjects undergo 2 laps that take about 60 minutes (6 workstation × 5 minutes × 2 laps), with 10 minutes of rest after each lap. In addition, walking endurance is trained by 30 minutes walking on the treadmill including rests if necessary. This is a progressive circuit and subjects while exercising receive feedbacks (visual and auditory) by the physiotherapist. Rests are used to discuss about difficulties and to provide further feedbacks. One session includes up to 3 patients and lasts 120 minutes, 5 days/week for 2 weeks. After this period they will receive a home-exercise maintenance program for 3 months.
16064549|NCT02421744|Behavioral|Delayed Onset TOCT|The control group will not receive any specific rehabilitation treatment for gait performance and mobility improvement. At any case, the control group will be authorized, at will, to exercise in non-rehabilitative contexts (i.e. swimming, walking, yoga) for 14 weeks. After this period they will receive TOCT as treatment plus a home-exercise maintenance program for 3 months.
16064550|NCT02421731|Device|Robot-assisted gait training|Patients will receive 12 training sessions, lasting for an hour with 30 minutes of real walking time, over 4 weeks (3 sessions/week) of RAGT. Subjects will wear a harness attached to a system to provide body weight support and they will walk on a treadmill with the help of a robotic-driven gait orthosis. The legs are guided according to a physiological gait pattern. The torque of the knee and hip drives can be adjusted from 100% to 0% for one or both legs. The speed of the treadmill can be adjusted from 0 km/h to approximately 3 km/h and body weight support from 0% to 100%. During the first session we will set these parameters according to subject characteristics and demand level. As training will progress, adjustments in the three parameters previously described will be performed.
16064551|NCT02421731|Other|Conventional therapy|The control group will receive 12 conventional therapy sessions over 4 weeks (3 sessions/week), that will focus on gait training. Subjects will receive 1 hour of individual conventional physiotherapy for session. During the first 5-10 minutes the subjects will perform lower-limb and core stretching exercises to increase muscles flexibility; then they'll deal with lower-limb muscles strengthening exercises tailored on their baseline characteristics (10 minutes). After that, assisted over-ground walking training will be performed.
16064552|NCT02421718|Radiation|Radiotherapy|
16064553|NCT02421705|Other|Sample collection|Collection of blood, feces samples, sample of nasal mucosa and biopsies (rectum and colon descendens), questionnaires and performance of rectal sensitivity measurement (barostat), MR scan of brain and transit measurement of colon
16064554|NCT02421692|Other|Progressive Rehabilitation|Progressive, high-intensity strengthening and functional interventions to facilitate independence with functional activities.
16064555|NCT02421679|Drug|TNX-102 SL|TNX-102 Sublingual tablets
16064557|NCT02421653|Dietary Supplement|MNP90|90 µg iodine-fortified micronutrient powder sachet (14 micronutrients); oral route; 1 daily
16064558|NCT02421653|Dietary Supplement|MNP45|45 µg iodine-fortified micronutrient powder sachet (14 micronutrients); oral route; 1 daily
16064559|NCT02421653|Dietary Supplement|IODISED OIL|200 mg iodine oil capsule; oral route; once at study start
16064560|NCT02421653|Dietary Supplement|INERT OIL|Non-iodised evening primrose oil capsule; oral route; once at study start
16064561|NCT02421653|Dietary Supplement|INERT MNP|Un-fortified powder sachet (maltodextrin, no micronutrients); oral route; 1 daily
16064562|NCT02421653|Dietary Supplement|NON-IODISED MNP|Un-fortified micronutrient powder sachet (14 micronutrients); oral route; 1 daily
16064563|NCT02421640|Drug|Cisplatin+TIL|cisplatin 100mg/m2(every three weeks),D1,D22,D43 of radiotherapy,then TIL infusing following concurrent chemoradiotherapy
16064564|NCT02421640|Drug|Cisplatin|cisplatin 100mg/m2(every three weeks),D1,D22,D43 of radiotherapy only
16064565|NCT02421627|Device|moxibustion|Acupoints: Tianshu (ST25，bilateral), Zusanli (ST36，bilateral). using mild-warm moxibustion，the surface temperature of acupoints were maintained at 43 ℃ ± 1 ℃, 30min for each acupoint, once every other day, three times a week, a total of six weeks treatment. After the treatment, subjects were followed up at weeks 12, 18 and 24.
16064566|NCT02421627|Device|Sham moxibustion|Acupoints: Tianshu (ST25，bilateral), Zusanli (ST36，bilateral); using sham mild-warm moxibustion，the surface temperature of acupoints were maintained at 37 ℃ ± 1 ℃, 30min for each acupoint, once every other day, three times a week, a total of six weeks treatment. After the treatment, subjects were followed up at weeks 12, 18 and 24.
16064567|NCT02421614|Other|high-protein low-carbohydrate diet with high olive oil|
16064568|NCT02421614|Other|high-protein low-carbohydrate diet with high sunflower oil|
16064569|NCT02421601|Drug|Condoliase|1.25 U, intradiscal injection, one time
16064570|NCT02421588|Drug|Lurbinectedin (PM01183)|
16064571|NCT02421588|Drug|Pegylated liposomal doxorubicin (PLD)|
16064572|NCT02421588|Drug|Topotecan|
16064573|NCT02421575|Drug|Hydroxychloroquine|Given PO
16064574|NCT02421575|Other|Laboratory Biomarker Analysis|Correlative studies
16064575|NCT02421562|Procedure|training in hypnoanalgesia|training nurses in hypnoanalgesia techniques to perform painful procedures in children followed in the outpatient hematology oncology clinic
16064576|NCT02421549|Device|Unpaired remote monitoring transmitter|
16064577|NCT02421536|Other|Vibrogent Smartphone Application|
16064578|NCT02421523|Procedure|Aim 2 Exercise group|The experimental group will participate in an isometric exercise strengthening intervention with a frequency of ~three times/week for 12 weeks. Training will include using a custom-built exercise set-up and a live monitoring system for all of the subjects who participate in the experimental group. Progression of the exercise program will only occur after safety assessments at weeks 3, 6, and 9. The safety assessments to occur at baseline, 1 week, 6 weeks, and 12 weeks include T2 MRI, Spectroscopic relaxometry, pain rating scale, and CK levels. The safety assessments to occur at 3 weeks and 9 weeks include the pain rating scale and CK levels. Participants in this group may also be tested for strength assessments (of the knee flexors and extensors) and time to climb 4 stairs.
16064579|NCT02421523|Procedure|Aim 1 Exercise Dosing|The maximal voluntary contraction (MVC) will be determined for each subject. The first four subjects will exercise at an intensity of ~30% of the subject's MVC. Subjects will be asked to perform ~4 sets of 6 reps of knee extension and knee flexion contractions. 48hs after the exercise is completed a safety assessment will be performed for muscle damage. If none has occurred, four additional subjects will perform the exercise at the next level of intensity (~50% MVC). Similarly, if no damage has occurred at ~50% MVC, four more subjects exercise at ~70% MVC. All safety measures will be performed 48hrs after the exercise has been completed at each of the levels. These safety assessments include T2 MRI, Spectroscopic relaxometry, pain rating scale, and CK levels.
16064580|NCT02421523|Procedure|Aim 2 Control group|This group will receive safety assessments at baseline, 1 week, 6 weeks, and 12 weeks including T2 MRI, Spectroscopic relaxometry, pain rating scale, and CK levels. They will also receive safety assessments at 3 weeks and 9 weeks that will include the pain rating scale and CK levels. Participants in this group may also be tested for strength assessments (of the knee flexors and extensors) and time to climb 4 stairs.
16064581|NCT02421510|Drug|Sotagliflozin|High dose Sotagliflozin, once daily, before the first meal of the day
16064582|NCT02421510|Drug|Sotagliflozin|Low dose Sotagliflozin,once daily, before the first meal of the day
16064583|NCT02421510|Drug|Placebo|Placebo, once daily, before the first meal of the day
16064584|NCT02421484|Biological|Allogeneic mesenchymal stromal cells|The allogeneic mesenchymal stromal cells will be administered intravenously.
16064585|NCT02421471|Drug|Ingenol mebutate 0.015 percent or 0.05 percent gel|Topical treatment with ingenol mebutate gel 0.015 percent or 0.05 percent gel of skin areas affected by AK
16064586|NCT02421458|Radiation|6 x 6 Gy|radiation in 6 fraction of 6 Gy, twice a week during 3 weeks
16064587|NCT02421458|Radiation|16 x 3.125 Gy|radiation in 16 fraction of 3.125 Gy, 4 times a week during 4 weeks
16064588|NCT02421432|Procedure|Transanal total mesorectal excision|Laparoscopy-assisted transanal total mesorectal excision
16064589|NCT02421419|Drug|Dexamethasone Sodium Phosphate|adreno-cortical steroid anti-inflammatory drug
16064590|NCT02421419|Drug|Xylocaine|a local anesthetic agent
16064591|NCT02421419|Drug|Sodium Chloride|Sodium chloride is a sterile, nonpryogenic solution for fluid and electrolyte replenishment
16064592|NCT02421406|Behavioral|Internet Behavioral Intervention|A series of 12 multi-media lessons will be accessible to participants on their own computers. The lessons (each of which takes about 15 minutes to complete) are based on the Diabetes Prevention Program (DPP) and Look AHEAD. Participants will be taught to record their weight, the calories and the fat grams in each food item, and their physical activity (in minutes) on a daily basis. At the end of the week, they will submit their self-monitored information to the study website and receive an automated feedback message about their progress to date. The lessons will also present key behavior change strategies such as cognitive restructuring, problem solving and relapse prevention.
16064627|NCT02421211|Drug|Ledipasvir (LDV)|Participants will receive 90 mg of LDV once daily as FDC tablet with SOF (Treatment B) in Panel 1 and Panel 2.
16064628|NCT02421211|Drug|Sofosbuvir (SOF)|Participants will receive 400 mg of SOF alone (Treatment C) in Panel 1 and as FDC tablet with LDV (Treatment B) once daily in Panel 2.
16066062|NCT02411448|Drug|Placebo|Administered IV.
16064593|NCT02421406|Behavioral|Internet Education Intervention|A series of 12 lessons will be accessible to participants on their own computers. Participants will be given information about normal, overweight and obese categories of body mass index, and provided information on the health problems that are associated with being overweight and the benefits of weight loss for treating and preventing such problems. General information about healthy eating will be provided. Participants will be educated about the benefits of increasing their physical activity, and strategies for increasing activity safely.
16064594|NCT02421393|Other|supervised exercise training|"Two weekly sessions of 75 min each, supervised by an exercise specialist in a dedicated gym facility. Each session will include: 5 min of warm up; 20 min of aerobic training using treadmill; 15 min of resistance training of muscle groups of skeletal sites of fragility fractures; 15 min of weight bearing exercises using weighted vests; 8 min of core stability training; 8 min of balance training; and 4 min of flexibility training. Weighted vest worn also during aerobic training and any occupational, home and leisure-time physical activity."
16064595|NCT02421380|Drug|Hyperpolarized Pyruvate|
16064596|NCT02421367|Biological|TDENV-PIV with AS03B adjuvant. Placebo: 0.9% Sodium Chloride Solution.|Tetravalent dengue virus purified inactivated vaccine (1 µg/virus type)
16064597|NCT02421354|Other|Laboratory Biomarker Analysis|Correlative studies
16064598|NCT02421354|Biological|Nivolumab|Given IV
16064599|NCT02421354|Other|Quality-of-Life Assessment|Ancillary studies
16064600|NCT02421341|Drug|Fentanyl|During study visits 2 and 3 you will receive an intrathecal (fluid filled space surrounding the spinal cord) injection of either fentanyl or placebo (saline). Fentanyl is an opiate (narcotic) drug and a common medication, however the way fentanyl is being used in this study is considered investigational.
16064601|NCT02421341|Procedure|Catheters|A catheter (small plastic tube placed in a blood vessel) will be placed in an artery in your arm and a second catheter will be placed in a vein in your leg. Local anesthetic will be used to minimize discomfort. These catheters will allow us to measure blood pressure, leg blood flow and draw blood.
16064602|NCT02421341|Other|Exercise|You will be asked to exercise, ride a stationary bike, at maximal exertion.
16064603|NCT02421341|Radiation|DEXA|During study visit one you will have a DEXA scan. This procedure requires you to lie on a table while a small x-ray tube passes under your body.
16064604|NCT02421341|Other|Pulmonary Function Tests|During study visit one you will be asked to perform 5 different breathing tests to help us better understand your lung function.
16064605|NCT02421341|Other|Blood Draw|You will have approximately 350 mls (1.25 cups) of blood drawn during the duration of this study.
16064606|NCT02421341|Other|Chemosensitivity Test|Using a bag you breath in and out your own air.
16064607|NCT02421341|Drug|Placebo|
16064608|NCT02421328|Device|CPAP first (Fisher & Paykel Healthcare)|Infants will start on nasal CPAP for 60 minutes and then switched to HHHFNC for anther 60 minutes. Ultrasonographic assessment of diaphragmatic dimensions and excursion will be done at the end of each 60 minute epochs.
16064609|NCT02421328|Device|HHHFNC first (Fisher & Paykel Healthcare)|Infants will start on HHHFNC for 60 minutes and then switched to nasal CPAP for anther 60 minutes. Ultrasonographic assessment of diaphragmatic dimensions and excursion will be done at the end of each 60 minute epochs.
16064610|NCT02421315|Behavioral|Exposure & Response Prevention (EX/RP) and when indicated medication treatment|Cognitive Behavioral Therapy (CBT) for OCD involves gradually exposing patients to anxiety provoking stimuli while having patients refrain from engaging in compulsive rituals and/or avoidance behaviors. There are three major components of CBT treatment for OCD, specifically: (1) exposure to anxiety provoking stimuli, (2) response prevention, and (3) cognitive techniques intended to decrease anxiety during the exposure and response prevention processes.
16064611|NCT02421302|Dietary Supplement|RUTF|This is ready-to-use-therapeutic-food
16064612|NCT02421289|Drug|Efavirenz|There will be adjusted dose of efavirenz in CYP2B6 guide group
16064613|NCT02421289|Drug|Efavirenz|If the patients was diagnosed as hypersensitivity to EFV, they will receive boosted-PI instead.
16064614|NCT02421289|Other|CYP450 2B6|All patients will be monitored drug level which should be in therapeutic level.
16064615|NCT02421276|Other|Phlebotomy|White blood cell analysis: Subtypes of white blood cells will be counted by flow cytometry
16064616|NCT02421263|Drug|Psilocybin|Participants will receive 20 mg/70 kg of psilocybin in the first session and will receive either 20 or 30 mg/70 kg in the second session.
16064617|NCT02421250|Device|Radical-7 Noninvasive Hgb Monitor|
16064618|NCT02421237|Behavioral|Narrative Enhancement and Cognitive Therapy|
16064619|NCT02421237|Behavioral|Supportive Group Therapy|
16064620|NCT02421224|Behavioral|Usual Care|Participants will receive in-person group counseling from a trained smoking cessation counselor. Participants will learn about reasons to quit smoking, strategies for quitting smoking, and additional resources available to support the quit attempt. Participants will also complete a quit plan.
16064621|NCT02421224|Behavioral|Deposits|Participants will have to deposit a certain amount of their own money at enrollment. Participants will be able to make additional voluntary deposits above the minimum amount during the intervention period. The participant will be refunded all deposits if he quits smoking at 3 months, as verified by a urine cotinine test. The participant will forfeit all deposits if he continues to smoke at 3 months, as verified by a urine cotinine test.
16064622|NCT02421224|Behavioral|Small Individual Bonus|Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test.
16064623|NCT02421224|Behavioral|Large Individual Bonus|Each participant will receive a monetary bonus from the study investigators if he or she quit smoking, as verified by a urine cotinine test. The bonus is twice the value of that in the Small Individual Bonus group.
16064624|NCT02421224|Behavioral|Teammate|Each participant will be randomly assigned one teammate to provide social support during the quit attempt. Each participant will be assigned to a participating coworker who speaks the same primary language and works the same work shift as the participant.
16064625|NCT02421224|Behavioral|Team Bonus|If the participant and assigned teammate both quit smoking at 3 months, as verified by a urine cotinine test, then each will receive a monetary bonus. The team bonus is equal in value to that in the Large Individual Bonus group.
16064626|NCT02421211|Drug|Simeprevir (SMV)|Participants will receive 150 milligram (mg) of SMV (Treatment A) once daily in Panel 1 and Panel 2.
16064629|NCT02421198|Behavioral|YMCA Family Diabetes Prevention Program (YFDPP)|12 week, group education to promote behavioral change delivered either face-to-face or via a combination of face-to-face and mobile technologies
16064630|NCT02421185|Drug|JNJ-42756493 (erdafitinib)|"Part 1: Participants will receive 8 mg tablet once daily from Day 1 to 7, and then Day 15 to 21 of 28 days cycle or 8 mg orally once daily of 28 days cycle up to the maximum tolerated dose in order to determine the recommended Phase 2 dose.
~Part 2: Recommended Phase 2 JNJ-42756493 (erdafitinib) dose determined in Part 1."
16064631|NCT02421172|Biological|CJM112|CJM112 Fully human IgG1 monoclonal antibody
16064632|NCT02421172|Drug|Placebo|
16064633|NCT02421159|Behavioral|Seek and Test Phase|The primary endpoint for this phase is the proportion of newly identified HIV infections of the RDS-ASTN intervention. Components for eligible and willing participants are a computerized baseline interview, counseling session, blood draw for HIV testing, HIV pre-test counseling, use of blood samples for clinical lab tests if found to be HIV infected, semi-structured interviews (if selected), the opportunity to recruit peers for the study, and the post-test counseling session.
16064634|NCT02421159|Behavioral|Treat and Retain Phase|The primary endpoints for this phase are: proportion linked to care within three months and time to the HIV care appointment. Participants with HIV infection who are interested in participating will be enrolled in this phase and navigated to HIV primary care over three months. Components are the locator form, patient navigation and support contacts, medical report form, follow-up contacts to update locator information, semi-structured interviews, follow-up interview, and blood draw for clinical lab testing.
16064635|NCT02421146|Device|Transcranial direct current stimulation|Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp.
16064636|NCT02421146|Device|Transcranial direct current stimulation - Sham|Transcranial direct current stimulation (tDCS) is a form of neurostimulation which uses constant, low current (at 2 mA) delivered to the brain area of interest(anode over the left DLPFC while cathode over the right suborbital region) via electrodes on the scalp.
16064637|NCT02421133|Other|Transitional care program.|"During the patient's stay in hospital, the transition nurse creates a transitional care file including information about the patient (inpatient medical and nurse care plan, medications), the discharge plan, and the contact information of the relevant primary care providers. She notifies the patient's primary care physician of the date of the discharge to home, of the potential medical problems and of the discharge care plan; a primary care physician visit is planned the month following the discharge.
~The day of the hospital discharge: meeting with the patient to review the follow-up recommendations. The transition nurse verifies that the medications are prescribed accordingly with the discharge plan, that the patient and his caregiver understand the prescription and are informed with the planned appointments and the biological monitoring.
~During 4 weeks after the hospital discharge: follow-up by the transition nurse once a week, alternately by telephone and home visit."
16064638|NCT02421133|Other|standard care program|The patients will be discharged according to the usual care plan of each participating hospital. The medical team does a medical and geriatric assessment of the patients according to the recommendations. The communication of information to the primary care providers (nurse, primary care physician…) is left to the discretion of the medical teams of the discharging hospitals, according to their habits of work.
16064639|NCT02421120|Drug|Ceftolozane/Tazobactam|1 hour intravenous infusion
16064640|NCT02421107|Other|Glysure CGM|
16064641|NCT02421107|Other|iStat intermittent testing|
16064642|NCT02421094|Drug|GR-MD-02|GM-MD-02 active
16064643|NCT02421094|Drug|Placebo|Placebo
16064644|NCT02421081|Procedure|vessel microsurgery|That is a surgery ro repair artery laceration.
16064645|NCT02421081|Procedure|tendon repair|That is a surgery ro repair tendon cut.
16064646|NCT02421081|Procedure|nerve microsurgery|That is a surgery ro repair median/ ulnar/ radial nerve cut.
16064647|NCT02421055|Procedure|Laparoscopic Roux-en-Y Gastric Bypass|
16064648|NCT02421055|Procedure|Laparoscopic Sleeve Gastrectomy|
16064649|NCT02421042|Drug|Lenvatinib|5- or 10-mg single oral dose of E7080, depending on their hepatic status [Mild (10 mg), Moderate (10 mg), and Severe Hepatic Impairment (5 mg) and Normal Hepatic Function (10 mg)].
16064650|NCT02421029|Drug|edetate calcium disodium|All subjects will receive a 250 mL 5% dextrose intravenous infusion over 1 hour that contains 1 gr of edetate calcium disodium
16064651|NCT02421016|Device|SYNERGY EES|Bioresorbable polymer everolimus-eluting stent
16064652|NCT02421016|Device|ABSORB [BVS]|Everolimus-eluting bioresorbable backbone stent
16064653|NCT02421003|Procedure|heart surgery|
16064654|NCT02420990|Behavioral|Medication Integration Protocol (MIP)|
16064655|NCT02420990|Behavioral|Changing Academic Support in the Home for Adolescents with ADHD (CASH-AA)|
16064656|NCT02420977|Drug|Pelvic DCFPyL PET-MRI fusion or PET/MRI|"Pelvic DCFPyL PET-MRI fusion or PET/MRI compared before and after 2-3 months of ADT
~Pelvic DCFPyL PET-MRI fusion or PET/MRI compared before and after 2-3 months"
16064657|NCT02420964|Other|video instruction|Patient Directed Video Instruction
16064658|NCT02420964|Other|Nurse instruction|Nurse directed instruction
16064659|NCT02420951|Drug|Bupivacaine|Injection of local anesthetic immediately prior to catheter removal, 24 hours postop.
16064660|NCT02420951|Other|No Intervention|No injection of local anesthetic immediately prior to catheter removal, 24 hours postop.
16064661|NCT02420938|Drug|Rituximab|375 mg/m2 by vein weekly for the first 4 weeks (Days 1, 8, 15, 22) then the day prior to each subsequent dose of Urelumab for the 12-week course.
16064662|NCT02420938|Drug|Urelumab|8 mg by vein given every 3 weeks for 4 doses, starting Day 2 of the 12-week course.
16064663|NCT02420925|Procedure|Celiac Plexus Block|Patients will undergo celiac plexus block via upper endoscopy with endoscopic ultrasound guidance. Injections will be performed using 0.75% bupivicaine and 40mg/ml of triamcinolone, ideally 1ml each directly into the celiac ganglia. If no ganglia is identifiable, then the injection will be performed into the celiac space, located at the take off of the celiac artery from the aorta.
16064664|NCT02420912|Drug|Ibrutinib|Given PO
16064665|NCT02420912|Other|Laboratory Biomarker Analysis|Correlative studies
16064666|NCT02420912|Biological|Nivolumab|Given IV
16064667|NCT02420899|Drug|rosuvastatin|10mg/d or 20mg/d,po
16064669|NCT02420873|Drug|Lorvotuzumab Mertansine (IMGN901)|100 mg/m2 by vein on Day 1 and 8 of a 21-day cycle.
16064670|NCT02420860|Biological|Elotuzumab|Given IV
16064671|NCT02420860|Drug|Lenalidomide|Given PO
16064672|NCT02420860|Other|Questionnaire Administration|Ancillary studies
16064673|NCT02420847|Drug|Doxorubicin Hydrochloride|Given IV
16064674|NCT02420847|Drug|Gemcitabine Hydrochloride|Given IV
16064675|NCT02420847|Drug|Ixazomib Citrate|Given PO
16064676|NCT02420834|Other|Hypromellose 0.15%|Tear supplement to be taken as required to relieve symptoms
16064677|NCT02420834|Other|Hypromellose 0.4%|Tear supplement to be taken as required to relieve symptoms
16064678|NCT02420834|Other|Carboxymethylcellulose|Tear supplement to be taken as required to relieve symptoms
16064679|NCT02420834|Other|Liposomal Spray|Tear supplement o be taken as required to relieve symptoms
16064683|NCT02420795|Drug|Akt/ERK Inhibitor ONC201|Given PO
16064684|NCT02420795|Other|Laboratory Biomarker Analysis|Correlative studies
16064685|NCT02420795|Other|Pharmacological Study|Correlative studies
16064686|NCT02420782|Drug|ASP6282|oral
16064687|NCT02420782|Drug|Itraconazole|oral
16064688|NCT02420782|Drug|Pilocarpine|oral
16064689|NCT02420782|Drug|Placebo|oral
16064690|NCT02420782|Drug|Midazolam|oral
16064691|NCT02420756|Device|PET Scan|
16064692|NCT02420743|Procedure|serum ferritin|serum ferritin will be measured serially at 26, 30 and 34 weeks gestation.
16064693|NCT02420743|Procedure|MCA Doppler|MCA peak systolic value will be assessed at 26, 30 and 34 weeks gestation.
16064694|NCT02420730|Drug|AGN-232411|AGN-232411 topical ophthalmic solution
16064695|NCT02420730|Drug|AGN-232411 Vehicle|Vehicle for AGN-232411 topical ophthalmic solution.
16064696|NCT02420717|Drug|Cyclophosphamide|Given IV
16064697|NCT02420717|Drug|Cytarabine|Given IV
16064698|NCT02420717|Drug|Dasatinib|Given PO
16064699|NCT02420717|Drug|Dexamethasone|Given PO or IV
16064700|NCT02420717|Drug|Doxorubicin|Given IV
16064701|NCT02420717|Other|Laboratory Biomarker Analysis|Correlative studies
16064702|NCT02420717|Drug|Leucovorin|Given IV or PO
16064703|NCT02420717|Drug|Mercaptopurine|Given PO
16064704|NCT02420717|Drug|Methotrexate|Given IV and PO
16064705|NCT02420717|Drug|Prednisone|Given PO
16064706|NCT02420717|Biological|Rituximab|Given IV
16064707|NCT02420717|Drug|Ruxolitinib Phosphate|Given PO
16064708|NCT02420717|Drug|Vincristine|Given IV
16064709|NCT02420704|Procedure|Embryo transfer|For fresh cycles, embryos were transferred 3-5 days after oocyte retrieval; For frozen thawed cycles, embryos were transferred 3-5 days after starting to use progesterone based on the stage of cryopreservation.
16064710|NCT02420691|Other|Laboratory Biomarker Analysis|Correlative studies
16064711|NCT02420691|Other|Pharmacological Study|Correlative studies
16064712|NCT02420691|Drug|Ribociclib|Given PO
16064713|NCT02420665|Drug|Proflavine|0.01% Proflavine applied topically to the cervix after colposcopy and HRME cervical images obtained.
16064714|NCT02420665|Device|HRME Imaging|HRME images obtained from one visually normal cervical site, and from up to 3 visually abnormal lesions based on exam and/or colposcopic findings.
16064715|NCT02420665|Behavioral|Phone Call|Study staff follow up with participant by phone one month after procedure.
16064716|NCT02420665|Procedure|Colposcopy|Colposcopy performed after visual inspection of cervix.
16064717|NCT02420665|Drug|Acetic Acid|3 - 5% added to cervix before visual inspection.
16064718|NCT02420652|Drug|Aspirin|Given PO
16064719|NCT02420652|Other|Laboratory Biomarker Analysis|Correlative studies
16064720|NCT02420652|Drug|Metformin Hydrochloride|Given PO
16064721|NCT02420652|Other|Placebo|Given metformin hydrochloride placebo PO
16064722|NCT02420652|Other|Placebo|Given aspirin placebo PO
16064723|NCT02420639|Device|Esophageal Cooling Device (ECD), manufactured by Advanced Cooling Therapy, Inc.|Use of the Esophageal Cooling Device for control of patient temperature.
16064724|NCT02420613|Other|Laboratory Biomarker Analysis|Correlative studies
16064725|NCT02420613|Radiation|Radiation Therapy|Undergo radiation therapy
16064726|NCT02420613|Drug|Temsirolimus|Given IV
16064727|NCT02420613|Drug|Vorinostat|Given PO
16064728|NCT02420587|Drug|AMG 208|Dose of AMG 208 is 400 mg by mouth daily given in 6 weeks cycles.
16064729|NCT02420587|Behavioral|Questionnaire|Questionnaire completion about pain at baseline, Day 22 of Cycle 1, Day 1 of Cycle 2, Day 22 of Cycle 2, every 6 weeks, and at end of study visit.
16064730|NCT02420574|Drug|albendazole BENDEX|randomized clinical trial with 2 parallel arms
16064731|NCT02420574|Drug|albendazole OVIS|
16064732|NCT02420561|Behavioral|Motivational Interviewing|"One in-person motivational interviewing session intervention that lasts for 45-minutes
~Additional two 15-minute telephone booster sessions post in-person 45 minute sessions"
16064733|NCT02420561|Behavioral|Control (brochure)|Participants received a brochure on alcohol and drug use risks.
16064734|NCT02420548|Behavioral|Parent Ed. and Youth Skills Coaching|The experimental intervention will have two components: (1) a caregiver parenting group, including all caregiver types (biological, foster, kinship), that meets weekly for 90-minutes for four months, focused on increasing parenting skills, and (2) a Life Coach component where trained and supported skills coaches meet individually with youth weekly for 60 minutes over the same four-month period to build the girls' social skills and peer/partner relationships skills.
16064735|NCT02420548|Behavioral|Services as Usual|Services as usual as provided by community service organizations from which the sample was drawn.
16064736|NCT02420535|Behavioral|Immediately Receive Tool|
16064738|NCT02420522|Device|Repetitive Transcranial Magnetic Stimulation|A non-invasive method of brain stimulation.
16064739|NCT02420522|Device|Sham Transcranial Magnetic Stimulation|A device designed to look, sound, and feel like a real magnetic stimulation coil without actually stimulating the brain.
16064740|NCT02420509|Drug|systemic chemotherapy|twelve months of 5-FU or capecitabine with bevacizumab starting 4-8 weeks after surgery
16064741|NCT02420496|Drug|Enteral fish oil|
16064742|NCT02420496|Drug|Ursodeoxycholic Acid|
16064743|NCT02420496|Drug|Placebo|
16064744|NCT02420483|Other|Cardiopulmonary resuscitation chest compressions|
16064745|NCT02420457|Procedure|Epidural injection|After evaluation by their pain physician, if the clinician offers an epidural injection for their back pain, they will be followed for this study before and after the injection.
16064746|NCT02420457|Drug|Epidural steroid injection as determined by routine care provider|Betamethasone Triamcinolone Dexamethasone Methylprednisolone Lidocaine Bupivacaine Ropivacaine Normal saline
16064747|NCT02420444|Biological|BCG SSI|The dose volume administered for BCG was 0.1 mL, and the mode of administration was ID injection to the deltoid area.
16064748|NCT02420444|Biological|Placebo|This is the identical buffer solution in which H4:IC31 was formulated. The dose volume administered for Placebo was 0.5mL, and the mode of administration was an IM injection.
16064749|NCT02420444|Biological|AERAS-404|AERAS-404 vaccine was reconstituted on site by adding 0.2 mL H4 antigen solution to 0.8 mL IC31 adjuvant solution. The dose volume administered for AERAS-404 was 0.5mL, and the mode of administration was an IM injection.
16064750|NCT02420431|Behavioral|Metacognitive Therapy|Metacognitive therapy (MCT) helps clients to identify episodes of worry and rumination in response to negative thoughts and bring these responses under control. This process is facilitated by exercises that enhance the flexibility of attention control, challenge unhelpful beliefs about thinking and enable new relationships with thoughts
16064751|NCT02420431|Behavioral|Cardiac Rehabilitation (treatment as usual)|Stress management, relaxation training, exercise and dietary advice.
16064752|NCT02420418|Dietary Supplement|N-acetyl-cysteine (NAC)|Patients will be randomly allocated into two groups, double-blind, to receive NAC or placebo for a period of 12 weeks. All groups remain receiving maintenance treatment in outpatient smokiing cessation. The dosage will be fixed 1800 mg/day of NAC administered in capsules taken 2 before breakfast and 2 before dinner is equal doses.
16064753|NCT02420418|Other|Placebo|Patients will be randomly allocated into two groups, double-blind, to receive NAC or placebo for a period of 12 weeks. All groups remain receiving maintenance treatment in smoking cessation service
16064754|NCT02420405|Procedure|Routine gene testing|For those diagnosed with nonsquamous NSCLC, routine gene testing including EGFR, ROS1 and ALK will be performed.
16064755|NCT02420405|Procedure|Next-generation sequencing|For those diagnosed with nonsquamous NSCLC and have done routine gene testing, NGS will be perform on those that have adequate rest tissues.
16064756|NCT02420392|Drug|Dapagliflozin|8 weeks treatment of dapagliflozin added to the type 2 diabetes patients with unsufficiently controlled with metformin or sulfonylurea
16064757|NCT02420379|Drug|eteplirsen|Eteplirsen 30 mg/kg will be administered as an IV infusion once a week for 96 weeks.
16064758|NCT02420353|Drug|Somatropin|GH dose will be calculated by nomogram estimation of body surface area, and will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin GH treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take GH, but otherwise patients will take GH every day over this 6 week period.
16064759|NCT02420353|Drug|Placebo|A placebo diluent that will be administered via subcutaneous injection in the abdominal area twice per day (BID) at a dose of the equivalent concentration of 0.5mg GH per body surface area (BSA) in m2 (0.5mg/m2). Patients will begin treatment one week prior to surgery and will continue through 5 weeks after surgery. On the day of surgery, patients will not take medication, but otherwise patients will take medication every day over this 6 week period.
16064760|NCT02420340|Behavioral|"HOPES Program (Helping Older People Experience Success)"|Weekly group skills training classes aimed at improving skills and knowledge in areas related to successful living in the community including: independent living, healthy living, social skills, leisure skills, and management of health care.
16064761|NCT02420327|Drug|Placebo patch & placebo capsule|On this test day, cognition is assessed after administration of a placebo patch and a placebo capsule.
16064762|NCT02420327|Drug|Placebo patch & galantamine capsule|On this test day, cognition is assessed after administration of a placebo patch and a galantamine capsule (4 mg p.o.).
16064763|NCT02420327|Drug|Nicotine patch & placebo capsule|On this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a placebo capsule.
16064764|NCT02420327|Drug|Nicotine patch and galantamine capsule|On this test day, cognition is assessed after administration of a nicotine patch (7 mg/24 hrs) and a galantamine capsule (4 mg p.o.).
16064765|NCT02420314|Drug|Paclitaxel|"Administered intravenously (IV)
~Prescribed at 200 mg/m2 (standard dose)
~Given once every 21 days (i.e., one cycle)
~Up to 4 cycles are administered depending on disease response"
16064766|NCT02420314|Drug|Carboplatin|"Administered intravenously (IV)
~Prescribed at AUC = 6 using the Cockcroft-Gault formula (standard dose)
~Given once every 21 days (i.e., one cycle)
~Up to 4 cycles are administered depending on disease response"
16064767|NCT02420314|Drug|Ascorbic Acid|"Administered intravenously (IV)
~75g per infusion
~Two infusions per week
~1 cycle is 3 weeks
~given up to 4 cycles
~may be given while chemotherapy if delayed due to low counts"
16064768|NCT02420301|Other|Tuina exercises|
16064769|NCT02420301|Other|Placebo Tuina exercises|
16064770|NCT02420288|Behavioral|Exercise Group|"Supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (before week 16 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training.
~Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60% of heart rate reserve. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate."
16064771|NCT02420275|Other|placebo|THIS GROUP WILL RECEIVE NO BRIGHT LIGHT
16064772|NCT02420275|Device|"Luminette,Lucimed Belgium"|THIS GROUP WILL RECEIVE BLEU LIGHT ENRICHIDED IN WITHE BRIGHT LIGHT
16064773|NCT02420262|Drug|insulin degludec/liraglutide|Once daily injected s.c./subcutaneously (under the skin) in combination with metformin.
16064774|NCT02420262|Drug|insulin glargine|Once daily injected s.c./subcutaneously (under the skin) in combination with metformin.
16064775|NCT02420262|Drug|insulin aspart|Injected s.c./subcutaneously (under the skin) before each main meal.
16064776|NCT02420249|Behavioral|Qigong training|Participants will learn the 18 Forms of Tai Chi Internal Qigong. Detailed movement and breathing descriptions of the Qigong training protocol can been found in Mak YK. 18 Forms Tai Chi Qigong [in Chinese]. 7th ed. Hong Kong: Wan Li Book Co.; 2012.
16064777|NCT02420236|Behavioral|High-intensity resistance training|
16064778|NCT02420236|Behavioral|General physical activity|
16064779|NCT02420236|Behavioral|Multidisciplinary rehabilitation program|
16064780|NCT02420223|Drug|Propranolol|
16064781|NCT02420210|Drug|Bendamustine Hydrochloride|Given IV
16064782|NCT02420210|Biological|Obinutuzumab|Given IV
16064783|NCT02420210|Drug|Dexamethasone|Given PO
16064784|NCT02420210|Other|Quality-of-Life Assessment|Ancillary studies
16064785|NCT02420210|Other|Laboratory Biomarker Analysis|Correlative studies
16064786|NCT02420197|Behavioral|High-intensity resistance training|
16064787|NCT02420197|Behavioral|General physical activity|
16064788|NCT02420197|Behavioral|Multidisciplinary rehabilitation program|
16064789|NCT02420184|Device|CPAP|Participants randomized into the experimental CPAP therapy arm will receive CPAP in addition to their standard medical therapy for CKD. CPAP will be worn whenever the participant sleeps for the duration of the study.
16064790|NCT02420184|Other|No CPAP|Participants randomized into the placebo comparator no CPAP arm will receive standard medical therapy for CKD.
16064791|NCT02420171|Other|Adding insulin to In Vitro culture media|We will add insulin for in vitro culture of human embryos
16064792|NCT02420158|Device|Trans-cutaneous vagal nerve electrical stimulation|
16064793|NCT02420145|Behavioral|Yoga|12 weeks of yoga, twice weekly for 90 minutes plus a whole-day workshop
16064794|NCT02420132|Other|Ranibizumab|Ranibizumab administered as part of standard-of-care
16064795|NCT02420119|Other|non interventional|
16064796|NCT02420106|Procedure|Osteopathic Manipulative Medicine|Osteopathic manipulative medicine involves manual technique to joints and soft tissue to improve movement.
16064797|NCT02420093|Device|"Pelvis Support Assembly"|"Use of a portable and adjustable Pelvis Support Assembly in the seat of the subject's work or home desk chairs as tolerated during the 3 weeks intervention interval. This pelvic support device supports the user from the pelvis and aids in maintaining a more anatomically neutral lumbar and pelvic position in sitting. This device is not officially named at this time but is as represented in US Patent number is US 8,857,906 B2."
16064798|NCT02420080|Drug|Brincidofovir|Rates of adenovirus progression and mortality in subjects with adenovirus infection and/or disease. Sites participating in the CMX001-304 study will be asked to participate in the CMX001-305 study retrospective data collection study.
16064799|NCT02420054|Behavioral|Intermittent fasting|Alternate day fasting (ADF) (water permitted) for 3 weeks with double energy intake every other day. Followed by ADF for 3 weeks with ad libitum diet on eating days.
16064800|NCT02420054|Other|Time control|Time control period with no change in eating habits.
16064801|NCT02420041|Procedure|Active comparator: Fluoroscopic Guided SIJ injection|"Needle entry point is in the lower one-third of the SIJ
~Sterile preparation (with chlorhexidine) and draping and 3 mL of 1% lidocaine injected subcutaneously at site of needle entry
~Under fluoroscopy guidance, Havel's Inc. EchoStim (facet tip) 21 Gauge 4 needle is inserted in a coaxial fashion into the SIJ
~1 mL of contrast (iohexol 300 mg/mL) is injected to outline the SIJ and to ensure no vascular uptake
~Injection of 20 mg of triamcinolone diluted in 4 mL of 1% lidocaine
~Patient observed in recovery bay for 20 minutes and then discharged home"
16064802|NCT02420041|Procedure|Ultrasound Guided Sacroiliac Joint Injection|"Sterile preparation (with chlorhexidine) and drape
~Using ultrasound guidance (SonoSite S-nerve) with a low frequency (2-5 Hz) curvilinear transducer in a sterile cover, the transducer is placed in a transverse plane over the SIJ and needle entry point is chosen at the medial end of the ultrasound transducer
~3 mL of 1% lidocaine is injected subcutaneously at site of needle entry
~Under ultrasound guidance, a Havel's Inc. EchoStim (facet tip) 21 Gauge 4 needle is inserted in a medial to lateral direction and guided into the SIJ. (0.5-2 mL of normal saline may be injected during needle insertion to locate tip of needle and to ensure solution does not spill out onto sacrum).
~After using the Doppler function to identify any surrounding vessels (to avoid intravascular injection), 20 mg of triamcinolone diluted in 4 mL of 1% lidocaine is injected.
~Patient observed in recovery bay for 20 minutes and then discharged home"
16064803|NCT02420041|Device|"Havel's Inc. EchoStim (facet tip) 21 Gauge 4 needle"|
16064804|NCT02420041|Device|SonoSite S-nerve|
16064805|NCT02420041|Device|iohexol|
16064806|NCT02420041|Drug|triamcinolone/lidocaine|
16064807|NCT02420028|Device|Insertion of OptiVein IV catheter|Placement of OptiVein IV catheter inside the vein allowing for fluid or drug delivery or blood withdrawal.
16064808|NCT02420028|Device|Insertion of Vasofix Certo IV catheter|Placement of Vasofix Certo IV catheter inside the vein allowing for fluid or drug delivery or blood withdrawal.
16064809|NCT02420015|Drug|Nicotine replacement therapy|Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum, nicotine inhaler, or nicotine nasal spray, and will be instructed to use the rescue method as needed to reduce cigarette cravings
16064810|NCT02420015|Drug|Bupropion|All participants who are medically eligible will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 3-month follow-up
16064811|NCT02420015|Behavioral|cognitive-behavioral smoking cessation counseling|Participants will receive four 20-minute smoking cessation counseling sessions and a participant manual. The four sessions are based on standard cognitive-behavioral therapy techniques shown to be efficacious for smoking cessation.
16064891|NCT02419599|Other|HE ONS|High energy density, low volume oral nutritional supplement (HE ONS) in addition to appropriate nutritional management
16064892|NCT02419599|Other|SE ONS|Standard energy density oral nutritional supplement (SE ONS) in addition to appropriate nutritional management
16064812|NCT02420015|Behavioral|Mobile Contingency Management|Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for videos that suggest smoking abstinence.
16064813|NCT02420015|Behavioral|Stay Quit Coach|Stay Quit Coach is a smart phone application that serves as a source of readily available support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment. The app guides user in creating tailored plans that include their personal reasons for quitting, interactive tools to help users cope with urges to smoke, motivational messages, support contacts to help users stay smoke free and how to address lapses. Participants assigned to this condition will be asked to use Stay Quit Coach from Session 2 through the 6-month follow-up.
16064814|NCT02420015|Behavioral|SMS text messaging|Patients assigned to this condition will receive text messages relevant to their current status in their smoking quit attempt, including messages reminding participants to take their smoking cessation medication.
16064815|NCT02420002|Drug|Use of MEOPA during suturing|Patients randomized to this arm will receive usual care, including MEOPA inhalation during local anesthetic injection and suturing of a wound.
16064816|NCT02420002|Other|Use of Hypnosis during suturing|Patients randomized to this arm will receive usual care as in the other arm, but before MEOPA inhalation is started, hypnosis will be tried. The local anesthetic injection and suturing of the wound will therefore take place under hypnosis (and MEOPA if necessary).
16064817|NCT02420002|Procedure|Stitch removal|6 to 15 days after the initial suturing, stitches will be removed according to usual procedures.
16064818|NCT02419976|Other|a breath analysis using the Aeonose|"using the Aeonose per standard acquisition protocol which spans 15 minutes of which the individuals breaths normally through a sterile disposable mouthpiece with sterile disposable air filters for 10 minutes during signal acquisition while wearing a nose plug. This will be completed in the office setting prior to their endoscopic procedure.
~Following their scheduled standard of care endoscopic procedure the patient will be allowed to consume a standardized refreshment (such as juice or soda) prior to discharge from the post procedure area. These refreshments are already provided as standard care. The participant will return to the office setting and repeat the same breath analysis acquisition process that was done prior to the procedure."
16064819|NCT02419976|Device|Aeonose|
16064820|NCT02419963|Procedure|endoscopy for tissue biopsy|endoscopy to obtain tissue biopsy for analysis of biomarker status
16064821|NCT02419963|Other|Blood Sample|Blood draw to evaluate serotonin and Vit D level.
16064822|NCT02419963|Other|Stool Sample|Stool sample to evaluate microbiome fingerprint.
16064823|NCT02419950|Device|Fixation of mesh in TEP|An endoscopic operative technique were mesh for preperitonelal placement in patients with inguinal hernias can be fixated in Place or left without fixation
16064824|NCT02419937|Drug|Tocilizumab|162 mg subcutaneously once (vs. 0.9% normal saline placebo injection once in placebo arm)
16064825|NCT02419937|Drug|Placebo|Saline injection
16064826|NCT02419924|Device|"the Bottom's Up"|A modified toilet seat that supports the perineum, preventing excessive pelvic floor descent and laxity which can cause constipation.
16064827|NCT02419911|Procedure|Laparoscopic surgery|gastrointestinal, gynecologic, urologic or bariatric laparoscopic surgery;
16064828|NCT02419911|Device|FloShield Defogging and Cleaning System|Sterile, single-use in vivo device to clean and defog the laparoscope camera lens
16064829|NCT02419911|Device|Clearify Defogging and Cleaning System|Single-use, ex vivo device to clean and defog the laparoscope camera lens
16064830|NCT02419872|Drug|Marketed antagonists|Medication for each patient is determined by the physician based on the patient's individual clinical profile and in accordance with the approved indication and label of the prescribed drug
16064831|NCT02419859|Device|PaQ® Insulin Delivery Device|PaQ is a 3 day insulin delivery device which delivers U 100 rapid-acting insulin. Provides basal insulin at preset basal doses and bolus insulin (in 2 unit increments) with a push of a button.
16064832|NCT02419859|Drug|Insulin, Asp(B28)-|a fast-acting analog of human insulin
16064833|NCT02419846|Other|Educational Intervention|Attend 10-20 minute PowerPoint presentation that will discuss prostate cancer facts, screening guidelines, risks, benefits, and consequences
16064834|NCT02419846|Procedure|digital rectal examination|Undergo digital rectal exam by a licensed healthcare professional. The results of this exam will be subjective as per clinician; however, will be coded as normal or abnormal. This is considered standard of care for prostate cancer screening
16064835|NCT02419846|Other|Pre-test administration|15 questions which test participants' knowledge of prostate cancer according to ACS guidelines. Questions will be multiple choices and true/false/unsure answers
16064836|NCT02419846|Other|Survey Administration|Survey will be administered at the end of the program for participants to assess their experience
16064837|NCT02419846|Other|Prostate-specific antigen measurement|PSA levels will be drawn and run as per institutional Laboratory standards. Criteria for referral and follow up will be assessed as per National Comprehensive Cancer Network (NCCN) guidelines
16064838|NCT02419846|Other|Post test administration|Post test will include the same 15 questions as on the pretest to assess for improvement in knowledge and understanding
16064839|NCT02419833|Procedure|Immediate invasive intervention|Invasive coronary angiography followed by either percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) surgery as soon as possible and/or within 2 hours of admission
16064840|NCT02419833|Procedure|Delayed invasive intervention|Invasive coronary angiography followed by either percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) surgery during the hospitalization and/or within 2-72 hours of admission
16064841|NCT02419833|Device|Coronary artery stenting|Implantation of coronary stents
16064842|NCT02419820|Drug|APD791|Temanogrel
16064843|NCT02419820|Drug|Clopidogrel|Clopidogrel
16064844|NCT02419820|Drug|Aspirin|Aspirin
16064845|NCT02419820|Drug|Placebo for APD791|Placebo for APD791
16064846|NCT02419807|Drug|Indocyanine Green Solution|Given subdermally
16064847|NCT02419807|Radiation|Technetium Tc-99m Sulfur Colloid|Given via injection
16064893|NCT02419586|Other|bubble gum|Chewing gum group patients performing gum chewing on postoperative day 1 at three times daily for 30 minutes after operation and until discharged.
16064848|NCT02419807|Procedure|Lymphoscintigraphy|This is a method used to check the lymph system for disease. A radioactive substance that flows through the lymph ducts and can be taken up by lymph nodes is injected into the body. A scanner or probe is used to follow the movement of this substance on a computer screen. Lymphoscintigraphy is used to find the sentinel lymph node (the first node to receive lymph from a tumor), which may be removed and checked for tumor cells. Lymphoscintigraphy is also used to diagnose certain diseases or conditions, such as lymphoma or lymphedema.
16064849|NCT02419807|Procedure|Axillary Lymph Node Biopsy|Undergo biopsy
16064850|NCT02419794|Procedure|endovascular treatment|endovascular treatment for acute ischemic stroke patients with large vessel occlusion
16064851|NCT02419781|Procedure|Rescue endovascular therapy|endovascular treatment using any devises for acute ischemic stroke patients with large vessel occlusion and not respond to intravenous recombinant tissue plasminogen activator (rt-PA) therapy
16064852|NCT02419781|Procedure|No endovascular therapy|
16064853|NCT02419768|Other|Physical Exercise|The physical exercise program will include 30 sessions of 60 minutes (twice a week). According to the recent guidelines, the program will include a specific work on balance, posture, gait, fitness, dual tasks and stretching.
16064854|NCT02419755|Drug|Bortezomib|Bortezomib will be given as a 1 mg/mL solution intravenous (IV) push over 3 to 5 seconds. For subcutaneous (SQ) administration, bortezomib will be mixed at 2.5 mg/ml.
16064855|NCT02419755|Drug|Vorinostat|Vorinostat should be taken orally (PO) with food.
16064856|NCT02419755|Drug|Mitoxantrone|Given by intravenous (IV) injection.
16064857|NCT02419755|Drug|Cytarabine|Given by intravenous (IV) injection.
16064858|NCT02419755|Drug|Methotrexate|Methotrexate will be given intrathecally (IT) along with hydrocortisone and cytarabine.
16064859|NCT02419755|Drug|Hydrocortisone|Hydrocortisone will be given intrathecally (IT) along with methotrexate and cytarabine.
16064860|NCT02419755|Drug|Peg-L-Asparaginase|Given by intravenous (IV) or intramuscular (IM) injection.
16064861|NCT02419755|Drug|Erwinia L-Asparaginase|To be used in case of allergy or intolerance to PEG-Asparaginase. Given by intravenous (IV) or intramuscular (IM) injection.
16064862|NCT02419755|Drug|Dexamethasone|Given orally (PO) or intravenously (IV).
16064863|NCT02419755|Drug|Mercaptopurine|Given orally (PO).
16064864|NCT02419755|Drug|Doxorubicin|Given intravenously (IV).
16064865|NCT02419742|Drug|Carboplatin|TCH regimen: Carboplatin dose = Target Area Under Curve (AUC) (6 milligrams*milliliter/minute [mg*mL/min]) multiplied by (Glomerular Filtration Rate [GFR] + 25). Carboplatin will be administered as IV bolus every 3 weeks for 6 cycles (Cycles 1 to 6).
16064866|NCT02419742|Drug|Cyclophosphamide|AC-TH regimen: Cyclophosphamide 600 mg/m^2 IV bolus every 3 weeks for 4 cycles (Cycles 1 to 4).
16064867|NCT02419742|Drug|Docetaxel|AC-TH regimen: Docetaxel 100 mg/m^2 IV infusion every 3 weeks for 4 cycles (Cycles 5 to 8). TCH regimen: Docetaxel 75 mg/m^2 IV bolus every 3 weeks for 6 cycles (Cycles 1 to 6).
16064868|NCT02419742|Drug|Doxorubicin|Participants will receive Doxorubicin 60 mg/m^2 administered as I.V. bolus injection over 5 to 15 minute every 3 weeks for 4 cycles for AC-TH regimen.
16064869|NCT02419742|Drug|Paclitaxel|AC-TH regimen: Paclitaxel 175 mg/m^2 IV infusion every 3 weeks for 4 cycles (Cycles 5 to 8).
16064870|NCT02419742|Drug|Trastuzumab|AC-TH regimen: For weekly administration, 4 milligrams per kilograms (mg/kg) loading dose on Day 1 of Cycle 5, followed by 2 mg/kg on Day 8 of Cycle 5 and 2 mg/kg every week for 4 cycles (up to Cycle 8). For 3 weekly administration, 8 mg/kg loading dose on Day 1 of Cycle 5, followed by 6 mg/kg every 3 for 4 cycles (up to Cycle 8). From Day 1 of Cycle 9, 6 mg/kg will be administered every 3 weeks up to Cycle 22. TCH regimen: For weekly administration, 4 mg/kg loading dose followed by 2 mg/kg weekly from Cycles 1 to Cycle 6. For 3 weekly administration, 8 mg/kg loading dose followed 6 mg/kg every 3 weeks from Cycles 1 to 6. From Cycle 7, 6 mg/kg every 3 weeks up to Cycle 18. All administrations will be intravenous (IV) infusion.
16064871|NCT02419729|Device|CO2 laser|SMARTXIDE2 V2LR (DEKA-Pulse) was used in each application using minimal parameters suggested by the laser's software ( Power of 30 W, 1000us emission time, 1000um spacing and a level of SmartStack 2)
16064872|NCT02419729|Drug|Estrogen|Topical estrogen cream treatment: Estriol 1mg daily.
16064873|NCT02419729|Drug|Placebo of Estrogen|Placebo of topical estrogen cream.
16064874|NCT02419729|Device|Placebo of CO2 laser|SMARTXIDE2 V2LR (DEKA-Pulse) was used in each applications using minimal parameters suggested by the laser's software but power of 0.5 W was stipulated for the placebo intervention and other parameters remained unchanged.
16064875|NCT02419716|Device|Cologuard|Prescription of Cologuard for at-home stool collection
16064876|NCT02419703|Device|STAR™ Tumor Ablation System|Targeted Radiofrequency ablation of painful metastatic tumor in the vertebral body.
16064877|NCT02419690|Behavioral|text message intervention|Subjects will be sent 58 messages (3-5 per week) over 12 weeks, plus reminder messages for follow up interviews. The content of these messages will focus on contraception methods and effectiveness, sexually transmitted infection (STI) transmission, condom use, partner and parental communication, and healthy relationships. There will also be several text messages asking the participant if they would like to have a health educator contact them. The format will include facts, quizzes, true/false and some will have links to videos/pictures and websites, and some will request a response.
16064878|NCT02419677|Procedure|Radiofrequency ablation|Radiofrequency ablation is performed percutaneously under CT/US guidance.
16064879|NCT02419677|Biological|Cytokine-induced killer cells|The patients received autologous cytokine-induced killer cells transfusion one week after RFA treatment.
16064880|NCT02419664|Drug|Gallium-68 DOTATOC PET|The intervention is to administer Ga-68 DOTATOC in pituitary patients doing PET/CT
16064881|NCT02419651|Drug|Tramadol|Women will receive oral tramadol 100 mg 1 hour before the procedure
16064882|NCT02419651|Drug|Diclofenac|Women will receive 100 mg diclofenac 1 hour before the procedure
16064883|NCT02419651|Drug|Placebo|Women will receive a placebo 1 hour before the procedure
16064884|NCT02419638|Drug|Rebif (IFN β-1a subcutaneous three times per week)|
16064885|NCT02419638|Drug|Tecifdera (dimethyl fumarate)|
16064886|NCT02419625|Behavioral|questionnaires|questionnaires , serum samples will be used
16064887|NCT02419612|Drug|Saxagliptin|
16064888|NCT02419612|Drug|Dapagliflozin|
16064889|NCT02419612|Drug|Glimepiride|
16064894|NCT02419573|Device|Endotracheal Intubation|In this traditional model of OHCA airway management, advanced-level Emergency Medical Services (EMS) personnel will use ETI as the primary (initial) airway management intervention. If the EMS agency is assigned to this arm, basic-level EMS personnel will use bag-valve-mask ventilation only even if they would normally use an LT.
16064895|NCT02419573|Device|Laryngeal Tube (King)|In this test model of OHCA airway management, advanced-level Emergency Medical Services (EMS) personnel will use LT as the primary (initial) airway management intervention. Basic-level EMS personnel will use bag-valve-mask ventilation. If trained to use LT, basic-level EMS personnel may perform LT insertion.
16064896|NCT02419560|Drug|ABT-199 and Ibrutinib Combination|Both are administered orally once daily.
16064897|NCT02419547|Drug|Versed|Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia
16064898|NCT02419547|Drug|Fentanyl|Phase 1: Standard induction of controled sedation with intravenous agent then programed stimulation to induce ventricular tachycardia
16064899|NCT02419547|Drug|Propofol|Phase 2: Standard induction of GETA with intravenous agent then programed stimulation to induce ventricular tachycardia
16064900|NCT02419547|Drug|Sevoflurane|Phase 3: Standard induction of GETA with inhalent agent then programed stimulation to induce ventricular tachycardia
16064901|NCT02419534|Drug|Polyethylene glycol|Laxative to treat constipation
16064902|NCT02419534|Drug|Polyethylene glycol with Diltiazem|Laxative and topical calcium channel blocker
16064903|NCT02419521|Device|Resolute Onyx Stent - 2.25 mm - 4.0 mm|
16064904|NCT02419508|Drug|Brinzolamide 1%/brimonidine 0.2% tartrate ophthalmic suspension|
16064905|NCT02419508|Drug|Brinz/brim vehicle|Inactive ingredients used as a placebo for masking purposes
16064906|NCT02419508|Drug|Prostaglandin analogue|
16064907|NCT02419495|Drug|Capecitabine|Given PO
16064908|NCT02419495|Drug|Carboplatin|Given IV
16064909|NCT02419495|Drug|Cyclophosphamide|Given IV
16064910|NCT02419495|Drug|Doxorubicin|Given IV
16064911|NCT02419495|Drug|Eribulin|Given IV
16064912|NCT02419495|Drug|Fluorouracil|Given IV
16064913|NCT02419495|Biological|Ipilimumab|Given IV
16064914|NCT02419495|Drug|Irinotecan Hydrochloride|Given IV
16064915|NCT02419495|Drug|Leucovorin Calcium|Given IV
16064916|NCT02419495|Biological|Nivolumab|Given IV
16064917|NCT02419495|Drug|Olaparib|Given PO
16064918|NCT02419495|Drug|Oxaliplatin|Given IV
16064919|NCT02419495|Drug|Paclitaxel|Given IV
16064920|NCT02419495|Biological|Pembrolizumab|Given IV
16064921|NCT02419495|Drug|Pemetrexed|Given IV
16064922|NCT02419495|Drug|Selinexor|Given PO
16064923|NCT02419495|Drug|Topotecan|Given IV
16064924|NCT02419482|Behavioral|4x4 minutes high intensity interval training|Treadmill running/walking with 10 minutes varm-up at 60-70% of maximum heart rate, 4x4 minute intervals at 90-95% of maximum heart rate separated by 3-minutes active pauses at 60-70% of maximum heart rate, and 3 minutes cool-down.
16064925|NCT02419482|Behavioral|10x1 minute high intensity interval training|Treadmill running/walking with 10 minutes varm-up at 60-70% of maximum heart rate, ten 1-minute intervals at maximal intensity (that can be performed for one minute), separated by 1-minutes active pauses at 60-70% of maximum heart rate, and 3 minutes cool-down.
16064926|NCT02419469|Drug|Cytarabine|"Participants initially receive intrathecal treatment using Cytarabine 100 mg on Day 1. Induction chemotherapy must begin within 3 days of the intrathecal Cytarabine dose.
~Consolidation Therapy 1: Cytarabine 75 mg/m2 subcutaneously Days 1 - 4 and 8 - 11.
~Consolidation Therapy 3B: Cytarabine 75 mg/m2 subcutaneously Days 1 - 4 and Days 8 - 11."
16064927|NCT02419469|Drug|Daunorubicin|Induction Therapy: Daunorubicin 25 mg/m2 by vein weekly for 4 doses.
16064928|NCT02419469|Drug|Vincristine|"Induction Therapy: Vincristine 1.5 mg/m2 by vein weekly for 4 doses.
~Consolidation Therapy 1: Vincristine 1.5 mg/m2 by vein Week 3 and Week 4.
~Consolidation Therapy 2: Vincristine 1.5 mg/m2 by vein every 10 days for 5 doses.
~Consolidation Therapy 3A: Vincristine 1.5 mg/m2 by vein weekly for 3 doses.
~Consolidation Therapy 3B: Vincristine 1.5 mg/m2 by vein Weeks 3 and 4.
~Maintenance Therapy (24 months): Vincristine 1.5 mg/m2 by vein every 28 days."
16064929|NCT02419469|Drug|Prednisone|Induction Therapy: Prednisone 60 mg/m2/day by mouth for 28 days.
16064930|NCT02419469|Drug|PEG asparaginase|"Induction Therapy: PEG asparaginase 2000 IU/m2 by vein on Day 4 of induction.
~Consolidation Therapy 1: PEG-asparaginase 2000 IU/m2 by vein Week 3 and Week 7.
~Consolidation Therapy 2: PEG-asparaginase 2000 IU/m2 by vein Weeks 1 and 4.
~Consolidation Therapy 3A: PEG-asparaginase 2000 IU/m2 by vein in Week 1.
~Consolidation Therapy 3B: PEG-asparaginase 2000 IU/m2 by vein Week 3."
16064931|NCT02419469|Drug|Ofatumumab|"Induction Therapy: Ofatumumab 300 mg by injection or vein on Day 2 and Ofatumumab 2000 mg by injection or vein on Day 15.
~Consolidation Therapy 1: Ofatumumab 2000 mg by injection or vein Week 1 and Week 5.
~Consolidation Therapy 2: Ofatumumab 2000 mg by injection or vein Week 1 and Week 5.
~Consolidation Therapy 3A: Ofatumumab 2000 mg by injection or vein Week 1 and Week 3."
16064932|NCT02419469|Drug|Rituximab|"Induction Therapy: If Ofatumumab not available, Rituximab 375 mg/m2 by vein on Day 1 and on Day 15.
~Consolidation Therapy 1: If Ofatumumab not available, Rituximab 375 mg/m2 by vein Week 1 and Week 5.
~Consolidation Therapy 2: If Ofatumumab not available, Rituximab 375 mg/m2 by vein Week 1 and Week 5.
~Consolidation Therapy 3A: If Ofatumumab not available, Rituximab 375 mg/m2 by vein Week 1 and Week 3."
16064933|NCT02419469|Drug|Methotrexate|"Induction Therapy: Intrathecal methotrexate 12 mg on Day 8 and Day 29.
~Consolidation Therapy 1: Intrathecal methotrexate 12 mg Weekly, Weeks 1 - 4.
~Consolidation Therapy 2: Methotrexate by vein every 10 days starting at 100 mg/m2 and increasing by 50 mg/m2 as tolerated. and Intrathecal methotrexate 12 mg Week 1.
~Consolidation Therapy 3A: Intrathecal methotrexate 12 mg in Week 1.
~Consolidation Therapy 3B: Intrathecal methotrexate 12 mg Week 1 and 2.
~Maintenance Therapy (24 months): Methotrexate 20 mg/m2 by mouth weekly, hold on days of intrathecal methotrexate.
~Maintenance Therapy (24 months): Intrathecal methotrexate 12 mg every 3 months for 4 doses."
16064934|NCT02419469|Drug|Cyclophosphamide|"Consolidation Therapy 1: Cyclophosphamide 1 gram/m2 by vein Week 1 and Week 5.
~Consolidation Therapy 3B: Cyclophosphamide 1 gram/m2 by vein Week 1."
16064935|NCT02419469|Drug|Mercaptopurine|"Consolidation Therapy 1: Mercaptopurine 60 mg/m2/day by mouth Days 1 - 14.
~Maintenance Therapy (24 months): Mercaptopurine 75 mg/m2 by mouth nightly."
16064936|NCT02419469|Drug|Doxorubicin|Consolidation Therapy 3A: Doxorubicin 25 mg/m2 by vein weekly for 3 doses.
16064937|NCT02419469|Drug|Dexamethasone acetate|"Consolidation Therapy 3A: Dexamethasone 10 mg/m2 by mouth on Days 1 - 7 and Days 15 - 21.
~Maintenance Therapy (24 months): Dexamethasone 6 mg/m2/day by mouth Days 1 - 5 every 28 days."
16064938|NCT02419469|Drug|Thioguanine|Consolidation Therapy 3B: Thioguanine 60 mg/m2/day by mouth for 14 days.
16064939|NCT02419456|Drug|MK-2048A IVR (Low Dose)|Contains 91 mg of vicriviroc (MK-4176) and 10 mg of MK-2048.
16064940|NCT02419456|Drug|MK-2048A IVR (Original Dose)|Contains 182 mg of vicriviroc (MK-4176) and 30 mg of MK-2048.
16064941|NCT02419443|Drug|Gabapentin|Gabapentin is a structural analogue of GABA that decreases activation of voltage-activated calcium channels which may decrease release of excitatory neurotransmitters such as glutamate. Its analgesic mechanisms have been utilized effectively for the treatment of chronic pain in several disorders such as cancer, fibromyalgia and diabetic peripheral neuropathy.
16064942|NCT02419443|Drug|Placebo|Control group
16064943|NCT02419430|Behavioral|MBRT ClassRoom and Phone Application|2 hours/week for 6 week, in classroom intervention involving mindfulness based resilience training.focused on mindfulness and self-compassion training, including body awareness, breath awareness, mindful movement, awareness of thoughts, and awareness of emotion. Core concepts included: normalizing experience of stress and changing one's relationship with an experience; learning to be a compassionate observer of self in order to appreciate the moment; recognizing undue efforts to control something that has already happened; shifting attention to felt body sense and away from the narrative; and redirecting attention to a value as a way of evoking positive states that enhance the present moment experience. Participants also use the smartphone to track their sleep and subjective well-being.
16064944|NCT02419430|Behavioral|Phone application only|"Participants will track their sleep and subjective well-being and also choose one of the following weekly challenges, which is completed via smartphone interactions:
~Joys of Life
~Count your blessings
~Think differenc, feel better
~Exercising --> Happier
~+ Exercising --> Sleep
~Pre-Sleep routine
~Eat that frog
~Mindful Meditation"
16064945|NCT02419430|Behavioral|Questionnaires|At baseline, immediately after the last MBRT session (6 weeks) and again at 3 and 6 months, all participants will complete questionnaires, including: 1) WHO-5 Well-Being Index; 2) DASS-21; 3) VAS-Fatigue; 4) MBI-Human Services version; 5) Self-Compassion Scale; 6) Connor-Davidson 2-item resilience scale; 7) Compassion to others scale.
16064946|NCT02419417|Drug|BMS-986158|Specified dose on specified days
16064947|NCT02419417|Biological|Nivolumab|Specified dose on specified days
16064948|NCT02419391|Biological|MVA BN RSV|Liquid frozen suspension of MVA-mBN294B
16064949|NCT02419391|Other|Placebo|Tris Buffered Saline, sterile
16064951|NCT02419352|Drug|Sugammadex|
16064952|NCT02419352|Drug|Neostigmine/atropine|
16064953|NCT02419339|Procedure|Extravesical ureteral reimplantation|Extravesical ureteral reimplantation with or without tapering
16064954|NCT02419326|Behavioral|Psychotherapy treatment|UNITE is a manualized, 22-session CBCT (cognitive behavioral couples therapy) intervention that engages the couple to target the core psychopathology of BED and address the uniquely challenging stress that BED places on intimate relationships.
16064955|NCT02419313|Drug|incobotulinumtoxinA|Subjects randomized to the active drug intervention arm will receive incobotulinumtoxinA (Xeomin). A series of rating scales and examinations will take place prior to treatment and for 24 weeks after treatment. At 12 weeks the subjects will cross over to the placebo (saline) arm.
16064956|NCT02419313|Drug|Saline|same volume as injected for incobotulinum toxin A into forearm muscles under EMG guidance.
16064957|NCT02419300|Device|ultrasoungraphy|pelvic ultrasonography and Doppler
16064958|NCT02419287|Drug|crizotinib|
16064959|NCT02419261|Drug|Analgesic nerve blockade (Ropivacaine)|Analgesic nerve blockade for Arthroscopic surgical repair of the anterior cruciate ligament
16064960|NCT02419261|Procedure|Arthroscopic surgical repair of the anterior cruciate ligament|
16064961|NCT02419235|Other|20% ethanol|Unmedicated 20% ethanol.
16064962|NCT02419235|Other|Homoeopathic complex|20% ethanol medicated with Amylenum nitrosum 6cH, Crataegus oxyacantha 6cH, Natrium muriaticum 6cH and Scutellaria lateriflora 6cH.
16064963|NCT02419222|Behavioral|Prism Adaptation|PAT uses wedged prism lenses to displace the entire visual field horizontally to the left or right (depending on the orientation of the base of the prism). The left-base prism lenses (thicker on the left) shift the entire visual field to the right. The result is a curving reaching trajectory, aiming toward the image location (right to the actual location) and then corrected toward the actual location. After several reaching movement, the coordinates of motor and visual systems are aligned, which in other words, is that the motor output adapts to the visual input, and thus the reaching trajectory is straight ahead to the object. This visually-guided goal-oriented movement is essential in PAT.
16064964|NCT02419209|Other|Sucrose pillules medicated with the Individualised Homeopathic Remedy|Sucrose pillules medicated with the Individualised Homeopathic Remedy and potency as selected by the researcher in accordance with the laws that govern individualised homeopathic prescribing.
16064965|NCT02419196|Other|Perioperative pulmonary function tests|Pulmonary electrical impedance tomography, spirometry, pulse oximetry and query performed preoperatively, at the first and the third postoperative day
16064966|NCT02419183|Other|SAMSTAR|This is a non-interventional study based on computer-administered WLR (SAMSTAR) test and examiner-administered WLR (RAVLT) test to investigate whether the performance of participants is equivalent.
16064967|NCT02419183|Other|RAVLT|This is a non-interventional study based on computer-administered WLR (SAMSTAR) test and examiner-administered WLR (RAVLT) test to investigate whether the performance of participants is equivalent.
16064968|NCT02419170|Procedure|Standard of care surgery|
16064969|NCT02419170|Procedure|Apheresis|
16064970|NCT02419170|Drug|Cyclophosphamide|
16064971|NCT02419170|Biological|Personalized mature dendritic cell vaccine|
16064972|NCT02419157|Drug|Selective enamel etching with 36% phosphoric acid|Etch: selective 36% phosphoric acid enamel etching
16064973|NCT02419157|Drug|No selective enamel etching with 36% phosphoric acid|Non-etch: without phosphoric acid selective enamel etching
16064974|NCT02419157|Device|Clearfil SE Bond|
16064975|NCT02419157|Device|Xeno V|
16064976|NCT02419144|Behavioral|AMI and campaigns|The intervention we are proposing is a tailored bi-level intervention with two components, an individual level component (component A) with tailored messages based on performance on clinical assessment results, ADLs and cognitive domains in the survey delivered through adapted motivational interviewing with practice to mastery (AMI-PM); , and a building level campaign (component B) for those enrolled in the study (but open to all building residents that includes building tailored messages based on cognitive domains and skills reinforcement through Practice to Mastery.
16064977|NCT02419131|Behavioral|Behavioral Headache Therapy|A standard, manualized behavioral intervention for primary headache disorders
16064978|NCT02419131|Behavioral|Cognitive Processing Therapy|A gold-standard treatment for PTSD, called Cognitive Processing Therapy
16064979|NCT02419131|Behavioral|Treatment as Usual|Treatment as usual, receiving standard care for PTHA
16064980|NCT02419118|Drug|Daratumumab|Treatment of myeloma patients with Daratumumab
16064981|NCT02419118|Drug|Lenalidomide|Treatment of myeloma patients
16064982|NCT02419118|Drug|Dexamethasone|Treatment of myeloma patients
16064983|NCT02419105|Drug|Testosterone|transdermal gel, 75 mg daily
16064984|NCT02419105|Drug|Colecalciferol|drink solution, 24000 IU once per month
16064985|NCT02419105|Drug|Placebo drink solution|drink solution, 0 IU Colecalciferol once per month
16064986|NCT02419105|Drug|Placebo transdermal gel|transdermal gel, 0 mg testosterone daily
16064987|NCT02419053|Other|Surgical Safety Checklist|An Ontario hospital-wide introduction of a surgical safety checklist based on the WHO guidelines, as mandated by the Ontario Ministry of Health
16064988|NCT02419040|Procedure|Barbotage|A 18-gauge needle connected to a 5 ml syringe with 4 ml of saline solution will be used to puncture the calcification with freehand technique and under constant sonographic monitoring. With the tip of the needle placed in the center of the deposit, the calcification will be flushed. Finally, a new 21-gauge needle will be introduced into the subacromial-subdeltoid bursa and 9 ml of 1% Lidocain hydrochlorid and 1 ml (20 mg) of Triamcinolon will be injected into the subacromial-subdeltoid bursa. All patients will be instructed by a physioteherapist in home exercises.
16064989|NCT02419040|Procedure|Corticosteroid injection|The tip of the 18-gauge needle will be placed in the soft parts outside of the rotator cuff and movements mimicking the lavage procedure will be performed. A lavage procedure usually takes 5 minutes and the same period of time will have to be used for the mimicking maneuver. Finally, a new 21-gauge needle will be introduced into the subacromial-subdeltoid bursa and 9 ml of 1% Lidocain hydrochlorid and 1 ml (20 mg) of Triamcinolon will be injected into the subacromial-subdeltoid bursa. All patients will be instructed by a physioteherapist in home exercises.
16064990|NCT02419040|Procedure|Lidocain injection (sham)|The tip of the 18-gauge needle will be placed in the soft parts outside of the rotator cuff and movements mimicking the lavage procedure will be performed. A lavage procedure usually takes 5 minutes and the same period of time will have to be used for the mimicking maneuver. Finally, a new 21-gauge needle will be introduced into the subacromial-subdeltoid bursa and 10 ml of 1% Lidocain hydrochlorid will be injected into the subacromial-subdeltoid bursa. All patients will be instructed by a physioteherapist in home exercises.
16064991|NCT02419027|Dietary Supplement|GI Flora|
16064992|NCT02419027|Dietary Supplement|Placebo|
16064993|NCT02419014|Device|Active CES Device Alpha-Stim®|The Alpha-Stim® device is a Class II FDA-approved device for the delivery of cranial electrotherapy using microcurrents that are delivered via two electrodes worn on the earlobes. Active CES devices will be pre-programmed by the manufacturer to deliver a bipolar, asymmetric rectangular waveform at a current of 100 µa, a level that is generally undetectable by the wearer of the device. At these settings, the manufacturer recommends a treatment duration of 60 minutes. Participants will not be able to alter the settings in any way.
16064994|NCT02419014|Device|Sham Device|The inactive (sham) devices look identical to the active device but are inactivated by the manufacturer so as not to deliver any electrical current.
16064995|NCT02419001|Drug|Period 1 - Treatment Sequence AB|Period 1: Ceftriaxone 1 g infused IV over 30 minutes only, no SYN-004
16064996|NCT02419001|Drug|Period 1 - Treatment Sequence AC|Period 1: Ceftriaxone 1 g infused IV over 30 minutes only, no SYN-004
16064997|NCT02419001|Drug|Period 2 - Treatment Sequence AB|Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 75 mg
16064998|NCT02419001|Drug|Period 2 - Treatment Sequence AC|Period 2: Ceftriaxone 1 g infused IV over 30 minutes and SYN-004 150 mg
16064999|NCT02418988|Drug|TACE plus rAd-p53 artery injection|Trans-catheter chemo-embolization (TACE) with rAd-p53 injection will be given every 21 days
16065000|NCT02418988|Drug|TACE|Trans-catheter chemo-embolization (TACE) without rAd-p53 injection will be given every 21 days
16065001|NCT02418975|Other|Very low-calorie protein-based diet|Patients will receive a homemade very low-calorie (~5 kcal/kg of ideal body weight /day) protein-based formula (milk proteins; 1.2 g per kilogram of ideal body weight) for 4 weeks by a polyurethane nasogastric feeding tube.
16065002|NCT02418975|Other|Hypocaloric diet|Patients will receive a commercial balanced enteral formula (~20 kcal/kg of ideal body weight /day; protein content, 1.0 g per kilogram of ideal body weight) for 4 weeks by a polyurethane nasogastric feeding tube.
16065003|NCT02418962|Biological|PfSPZ Vaccine|Aseptic, purified, metabolically active, non-replicating (live, radiation attenuated) cryopreserved Plasmodium falciparum sporozoites vaccine
16065004|NCT02418962|Other|Normal Saline|0.9% Sodium chloride solution for injection
16065005|NCT02418949|Drug|Cyproheptadine|"Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.
~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug"
16065006|NCT02418949|Drug|Placebo for Cyproheptadine|"Cyproheptadine will be titrated up to the chronic dose prior to involvement in hand therapy as well as gradually down to zero in the two weeks following treatment.
~Week 1 dose: 4mg taken twice daily (orally) Week 2 dose: 8mg taken twice daily (orally) Week 3 dose: (chronic dose): 8 mg taken three times daily (orally). Week 4-9: (chronic dose): 8 mg taken three times daily (orally). Week 10: 8 mg taken twice daily (orally). Week 11: 4 mg taken twice daily (orally). Week 12: no drug"
16066063|NCT02411448|Drug|Erlotinib|Administered orally.
16065007|NCT02418949|Other|Active Movement Practice (AMP)|Participants will alternate between active training with a custom video game and a robot active-assistive Voice and EMG-Driven Actuated (VAEDA) glove during active training occupational therapy.
16065008|NCT02418949|Other|Passive Cyclical Stretching|Participants will wear the actuated device/glove for the duration of the training sessions (2 20-min stints followed by 10 min of rest) during which time the actuated glove will cyclically stretch the joints of the digits in the hand between flexion and extension while remaining passive/relaxed.
16065009|NCT02418936|Device|gene diagnostic kit|
16065010|NCT02418923|Other|Procedure: Blood specimen collection|Blood specimen collection
16065011|NCT02418884|Drug|rosuvastatin|CAD patients with diabetes who confirmed CAC will receive rosuvastatin (20mg/d) therapy for 24 months.
16065012|NCT02418871|Device|FluidVision AIOL|Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject. An improved injector system was used.
16065013|NCT02418871|Procedure|Cataract surgery|Performed using standard microsurgical techniques
16065014|NCT02418858|Procedure|Deep Brain Stimulation surgery|Deep Brain Stimulation surgery awake vs. asleep
16065015|NCT02418845|Drug|SYM-1219|
16065016|NCT02418845|Drug|Placebo|
16065017|NCT02418832|Procedure|Sperm cell aspiration and TEFNA|Testicular Fine Needle Aspiration (TEFNA)
16065018|NCT02418819|Drug|PF-06412562 3mg BID|PF-06412562
16065019|NCT02418819|Drug|PF-06412562 9mg BID|PF-06412562
16065020|NCT02418819|Drug|PF-06412562 45mg BID|PF-06412562
16065021|NCT02418819|Other|Placebo|Placebo
16065022|NCT02418806|Behavioral|Psychotherapy groups|
16065023|NCT02418806|Behavioral|Self-help groups|
16065024|NCT02418793|Drug|MOD-5014|Long Acting Factor VIIa
16065025|NCT02418780|Other|Tai Chi|6-month Tai Chi exercise program meeting 2 times per week plus DVD for home practice
16065026|NCT02418767|Drug|MOD-4023|
16065027|NCT02418767|Drug|Placebo|
16065028|NCT02418754|Drug|REGN2176-3|
16065029|NCT02418754|Drug|Intravitreal Aflibercept Injection (IAI)|
16065030|NCT02418741|Other|Neck flexion|Patient's neck was flexed using a 4 cm or 8 cm height of pillow
16065031|NCT02418728|Other|subcutaneous adipose tissue microdialysis under local beta/alpha blockade|adipose tissue lipolysis under local beta/alpha blockade in abdominal subcutaneous adipose tissue, using microdialysis
16065032|NCT02418715|Other|Water Aerobics Training|
16065033|NCT02418702|Drug|0.2 mg/kg ketamine|20 patients will randomly be assigned 0.2 mg/kg of Ketamine
16065034|NCT02418702|Other|placebo|20 patients will randomly be assigned a placebo
16065035|NCT02418689|Drug|NOV120101 (Poziotinib)|NOV120101 (Poziotinib) 12 mg PO once daily for 2 weeks followed by a 1-week drug-free interval between cycles until disease progression or unacceptable toxicity development
16065036|NCT02418676|Drug|Gel with HPβCD-I complex|"Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with hydroxypropyl-beta-cyclodextrin complexed with insulin (HPβCD-I) was placed on the pressure ulcer and covered with sterile gauze and a transparent film.
~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
16065037|NCT02418676|Drug|Gel with insulin|"Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of gel with insulin was placed on the pressure ulcer and covered with sterile gauze and a transparent film.
~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
16065038|NCT02418676|Drug|Control gel|"Initially, the pressure ulcer was cleaned with saline. With the aid of a paper ruler, the ulcer was measured and photographed, as the ruler included the date and the initials of the patient. After measuring, a quantity of 5 grams of control gel was placed on the pressure ulcer and covered with sterile gauze and a transparent film.
~The curative was changed once a day during the treatment period, unless there was leakage of fluid, contamination, or signs of infection. Every three days the pressure ulcers of all patients were measured and photographed again, resulting in a total of six measurements per patient. The photos of pressure ulcers were evaluated for measurement of pressure ulcers and any kind of irritation."
16065039|NCT02418663|Drug|Fluid challenge (250 ml Lactated Ringer's solution)|"When VE is prescribed to a patient, a fluid challenge of 250mL Lactated Ringer's solution will first be administered. The ccNexfin system will be used to predict FR (SV increases by at least 15% in response to a fluid challenge). The remaining amount of fluid ordered by the treating team will then be administered, and SV will again be measured.
~Additionally, a daily fluid challenge with 250mL of Lactated Ringer's will also be administered, with FR recorded as above"
16065040|NCT02418650|Drug|ODM-201 300 mg tablet|
16065041|NCT02418650|Drug|intravenous14C-ODM-201|
16065042|NCT02418650|Drug|300 mg 14C-ODM-201 oral solution|
16065043|NCT02418637|Other|Worksite screening for DM, HTN and hyperlipidemia|Six monthly visits to worksite to perform screenings
16065044|NCT02418624|Drug|carboplatin, olaparib|2 cycles of carboplatin and olaparib combination therapy followed by olaparib monotherapy.
16065045|NCT02418598|Genetic|Cohort1|AAV-hAADC-2 is administered via bilateral intra-putaminal infusion. The number of vector genomes (vg) administered in this cohort is 3x10^11 vg/subject.
16065046|NCT02418598|Genetic|Cohort2|AAV-hAADC-2 is administered via bilateral intra-putaminal infusion. The number of vector genomes (vg) administered in this cohort is 9x10^11 vg/subject.
16065047|NCT02418585|Drug|Esketamine|Participants will self-administer either 56 mg or 84 mg of esketamine, intranasally, twice per week as a flexible dose regimen in the Double-Blind Induction Phase.
16065128|NCT02417987|Other|Placebo|The skin was penetrated with a needle and few drops of saline injected in the soft tissue away from the tendon
16065048|NCT02418585|Drug|Placebo|Participants will self-administer matching placebo, intranasally, twice per week for 4 weeks as a flexible dose regimen in the Double-Blind Induction Phase.
16065049|NCT02418585|Drug|Duloxetine (Oral Antidepressant)|Duloxetine could be selected as the oral antidepressant medication by the investigator based on review of Massachusetts General Hospital - Antidepressant Treatment Response Questionnaire (MGH-ATRQ) and relevant prior antidepressant medication information. The minimum therapeutic dose is 60 milligram per day (mg/day).
16065050|NCT02418585|Drug|Escitalopram (Oral antidepressant)|Escitalopram could be selected as the oral antidepressant medication by the investigator based on review of MGH-ATRQ and relevant prior antidepressant medication information. Escitalopram will be titrated upto a dose of 20 mg/day, but if not tolerated the dose can be reduced to the minimum therapeutic dose of 10 mg/day.
16065051|NCT02418585|Drug|Sertraline (Oral Antidepressant)|Sertraline could be selected as the oral antidepressant medication by the investigator based on review of MGH-ATRQ and relevant prior antidepressant medication information. Sertraline will be titrated upto a dose of 150 mg/day, but if not tolerated the dose can be reduced to the minimum therapeutic dose of 50 mg/day.
16065052|NCT02418585|Drug|Venlafaxine Extended Release (XR) (Oral Antidepressant)|Venlafaxine Extended Release could be selected as the oral antidepressant medication by the investigator based on review of MGH-ATRQ and relevant prior antidepressant medication information. Venlafaxine Extended Release will be titrated upto a dose of 225 mg/day, but if not tolerated the dose can be reduced to the minimum therapeutic dose of 150 mg/day.
16065053|NCT02418572|Drug|Testosterone gel|"Patients will receive once daily application of 0.55 gr testosterone gel-TTG (GROUP A) (Testosterone gel 1%; Laboratories Besins International, Paris, France) with a 5.5 mg/d nominal delivery rate of testosterone starting from day 1 or 2 of the following menstrual cycle, for approximately 65 days.
~The application will be administered in the morning by the patient onto clean dry healthy skin over external surface of the thighs. The gel will be simply spread on the skin gently as a thin layer.
~TTG will start on the day of enrollment and will continue until patients' menstruation (28-30 days). Daily administration of TTG or placebo will continue for 35 days (21days until the initial of downregulation with triptorelin and for 14 more days until the initiation of ovarian stimulation with HP-hMG). Ovarian stimulation will commence the day after last testosterone gel application. (GROUP A)"
16065054|NCT02418572|Drug|Placebo gel|"Patients will receive once daily application of 0.55 gr of placebo gel from day 1 or 2 of the following menstrual cycle, for approximately 65 days.
~The application will be administered in the morning by the patient onto clean dry healthy skin over external surface of the thighs. The gel will be simply spread on the skin gently as a thin layer.
~Placebo gel will start on the day of enrollment and will continue until patients' menstruation (28-30 days). Daily administration of placebo gel will continue for 35 days (21 days until the initial of downregulation with triptorelin and for 14 more days until the initiation of ovarian stimulation with HP-hMG"
16065055|NCT02418559|Drug|JNJ-63623872 (300 mg)|Participants will receive JNJ-63623872 300 mg tablet orally once on Day 1 under fasted conditions.
16065056|NCT02418559|Drug|JNJ-63623872 (600 mg)|Participants will receive JNJ-63623872 600 mg (2*300 mg) tablet orally once on Day 1 under fasted conditions.
16065057|NCT02418559|Drug|JNJ-63623872 (1200 mg)|Participants will receive JNJ-63623872 1200 mg (4*300 mg) tablet orally once on Day 1 under fasted conditions.
16065058|NCT02418559|Drug|Placebo|Participants will receive placebo tablet orally once on Day 1 under fasted conditions.
16065059|NCT02418546|Behavioral|In-Person Nutritional Counseling by a Registered Dietitian|
16065060|NCT02418546|Behavioral|Nutritional counseling using an e-Health Application|
16065061|NCT02418533|Drug|menotropin|Menopur is used for controlled ovarian stimulation (COH)
16065062|NCT02418533|Drug|Recominant Follicle Stimulating Hormone (rFSH)|Gonal-f is used for controlled ovarian stimulation (COH)
16065063|NCT02418520|Device|Miswak|Oral hygiene with Miswak chewing sticks and normal tooth brush
16065064|NCT02418507|Dietary Supplement|Proprietary Probiotic Blend|A proprietary probiotic blend: Lactobacillus acidophilus, Bifidobacterium lactis, Bifidobacterium longum, and Bifidobacterium bifidum at 56.75 mg
16065065|NCT02418507|Other|Placebo|The placebo is administered to randomized healthy participants
16065066|NCT02418494|Other|Concept Elicitation|Complete cognitive interview to elicit relevant HSIL symptoms, compare to study index of symptoms, and rank symptoms in relation to effect on health-related quality of life
16065067|NCT02418494|Other|Comprehension Assessment|Comprehension assessment of draft quality of life assessment
16065068|NCT02418481|Biological|DC-CIK|DC-CIK cells will be used against tumor cells.
16065069|NCT02418481|Biological|γδ T Cell|γδ T cells will be used against breast tumor.
16065070|NCT02418481|Biological|Combination|γδ T/DC-CIK cells will be used against breast tumor.
16065071|NCT02418468|Drug|Indacaterol|Indacaterol 150µg capsules for inhalation daily
16065072|NCT02418468|Drug|Placebo|Matching placebo indacaterol capsules for inhalation daily
16065073|NCT02418455|Drug|UX003|solution for intravenous infusion
16065074|NCT02418429|Other|waxy maize starch|pancake test meal with waxy maize starch only
16065075|NCT02418429|Other|waxy maize starch and Whey Protein|pancake test meal with waxy maize starch and whey protein
16065076|NCT02418429|Other|Resistant Starch|pancake test meal with resistant starch only
16065077|NCT02418429|Other|resistant starch and whey protein|pancake test meal with resistant starch and whey protein
16065078|NCT02418416|Other|Oocyte double chemical activation|Oocyte double chemical activation
16065079|NCT02418403|Behavioral|Financial incentive|Offer of money designed to overcome barriers to advance care planning.
16065080|NCT02418403|Behavioral|Educational website|"Research-verson of the Prepare for your care website (www.prepareforyourcare.org)"
16065081|NCT02418390|Procedure|prophylactic central lymph node dissection|dissection of level VI compartment by AAHNS (American association of head and neck surgeons) classification
16065082|NCT02418364|Other|Placebo reflexology treatment|Placebo reflexology treatment will be done in the same rate as the reflexology treatment itself, but will be superficial in particular,and will be directed to organs and organ systems which are not relevant to the research topic.
16065126|NCT02418013|Other|Placebo group|"A placebo agent is administered through intravenous at CHA clinical trail institute.
~It should be certain that when administered, participants are not aware of which treatments are preformed."
16065083|NCT02418364|Other|Reflexology treatment|Reflexology treatment will be done until the eggs implant. If the patient is not pregnant, she will start another reflexology treatment cycle. There will be minimum 4 and up to 6 reflexology treatments in every IVF cycle (maximum three IVF cycles) . Rate treatment will be two or three times a week.
16065084|NCT02418338|Other|speckle tracking (2D strain) echocardiography|2D echocardiography videos of both ventricles to perform 2D strain post-examination evaluation
16065085|NCT02418325|Biological|Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells|Super selective intravenous administration of 50 million Allogeneic Human Umbilical Cord Tissue-Derived Mesenchymal Stem Cells (UC-MSC) and intrathecal administration of UC-MSCs in dose of 100 million along with liberation therapy (when associated with CCSVI)
16065086|NCT02418325|Other|Liberation therapy|
16065087|NCT02418312|Drug|histamine-2 receptor antagonist|famotidine 40 mg qd plus thienopyridine
16065088|NCT02418312|Drug|Placebo|placebo plus thienopyridine
16065089|NCT02418299|Device|IncontiLase Er:YAG laser treatment|Each patient will receive 2-3 sessions of Er:YAG laser treatment for stress and mixed urinary incontinence (IncontiLase)
16065090|NCT02418286|Other|expose to any drugs or procedures based on traditional Korean medicine theory|There are no specific interventions associated with this registry as it is purely observational study of medical utilization.
16065091|NCT02418273|Drug|denosumab|These subjects will receive two doses of denosumab.
16065092|NCT02418260|Procedure|Bridge Plate osteosynthesis|Trough two anterior skin incisions, the 4.5mm narrow DCP plate will be placed on the anterior surface of the humerus and, after indirect reduction, it will be fixed to the bone with 2 proximal and 2 distal screws.
16065093|NCT02418260|Procedure|Locked intramedullary nail osteosynthesis|Trough an anterolateral approach to the shoulder, the supraspinatus tendon will be longitudinally splited allowing the insertion of the intramedullary nail.
16065094|NCT02418260|Procedure|Open reduction and plate osteosynthesis|Trough an posterior or anterolateral approach, the fracture will be directly reduced and fixed with a broad DCP 4.5mm plate.
16065095|NCT02418247|Drug|I131|
16065096|NCT02418247|Drug|I123|
16065097|NCT02418234|Other|mutation detection|
16065098|NCT02418234|Other|ARMS and ddPCR|
16065099|NCT02418234|Genetic|ctDNA analysis|
16065100|NCT02418221|Dietary Supplement|DAOSiN®/ Placebo & ProvokAmin® Ingestion|Proband is randomly assigned Daosin® or the Placebo before provocation with ProvokAmin®
16065101|NCT02418221|Procedure|Drawing blood, measuring BP & pulse|Taking of a blood sample and recording of blood pressure & pulse
16065102|NCT02418208|Diagnostic Test|Performint EEG tests and BNA analysis|
16065104|NCT02418182|Drug|Acetaminophen|Acetaminophen total dose of 1000mg
16065105|NCT02418182|Drug|placebo|subjects randomized to this group will be given placebo tablets
16065106|NCT02418156|Device|CorMatrix ECM for Vascular Repair|Standard femoral arterial interventional procedure using CorMatrix ECM for vascular repair.
16065107|NCT02418143|Device|CorMatrix CanGaroo ECM Envelope|Subjects who have received CorMatrix CanGaroo ECM Envelope for an implantable electronic device placement following a battery change or upgrade.
16065108|NCT02418130|Drug|Ursodeoxycholic acid, taurine, ginsenoside, thiamine, inositol|
16065109|NCT02418130|Drug|Placebo|
16065110|NCT02418117|Other|Stereolitographic template|Flapless (atraumatic) dental implants insertion with the aid of a stereolitographic template.
16065111|NCT02418104|Drug|CHS-1701|
16065112|NCT02418104|Drug|Pegfilgrastim (Neulasta)|
16065113|NCT02418091|Behavioral|Telehealth|Using Telehealth to slow progression of diabetic kidney disease automated population program identifies patients and engages them to optimize DKD medication adherence and health behaviors using 2-way communication via patient-selected technology (mobile/web-based applications, text messaging, interactive voice response, or e-mail) backed by case management via the phone for suboptimal control or health status. The STOP-DKDAutomated Population Program will deliver a tailored, multi-factorial intervention to address medication self-management and modify multiple risk factors simultaneously through a combination of patient self-monitoring, behavioral therapies and education that optimize adherence and self-efficacy.
16065114|NCT02418078|Procedure|local infiltration anesthesia and sedation|the surgical site is infiltrated with local anesthetic agents and the patients are sedated with intravenous agents
16065115|NCT02418065|Other|training on ergonomic bicycle|
16065116|NCT02418065|Drug|Testosterone|
16065117|NCT02418065|Drug|Oral nutritional supplementation|
16065118|NCT02418065|Drug|n3 polyunsaturated fatty acid|
16065119|NCT02418052|Procedure|neck flexion|After the cervical esophagogastric anastomoses is completed and the skin incision is closed, the patient's occiput will be lifted, and then the neck will be maintained in flexing position by an assistant. The underside of the chin will be fixed to the anterior chest wall with two stout nylon sutures by the surgeon. The neck will be fixed in the neutral flexing position for 7 to 10 days after surgery.
16065120|NCT02418039|Dietary Supplement|High protein diet|It has been suggested that administrating a high protein diet in patients with liver cirrhosis and with minimal hepatic encephalopathy could prevent the development of malnutrition, increase the detoxification of ammonia by the muscle to consequently delay the onset overt hepatic encephalopathy and prolong patient survival. However, information is scarce and inconclusive regarding the potential role of dietary protein in the prevention and treatment of minimal hepatic encephalopathy.
16065121|NCT02418039|Dietary Supplement|Normal protein|A normal protein diet will be administrated in patients with MHE.
16065122|NCT02418026|Other|hypnosis|Conversational hypnotic induction and therapeutic suggestions
16065123|NCT02418013|Other|Fresh cord blood(experimental group A)|"Cord blood is administered through intravenous at CHA clinical trail institute.
~Chlorpheniramine maleate at the concentration of 0.6ml/10kg is administered prior to the treatment."
16065124|NCT02418013|Other|Frozen cord blood(experimental group B)|"Cord blood is administered through intravenous at CHA clinical trail institute.
~Chlorpheniramine maleate at the concentration of 0.6ml/10kg is administered"
16065125|NCT02418013|Other|Frozen plasma(experimental group C)|"Cord blood is administered through intravenous at CHA clinical trail institute.
~Chlorpheniramine maleate at the concentration of 0.6ml/10kg is administered"
16065129|NCT02417987|Drug|High Volume injection|Injection with10 mls 0.5% bupivacaine hydrochloride and 20 mg of Depomedrol 40 mls saline (NaCl) around the tendon
16065130|NCT02417987|Biological|Autologous conditioned plasma (ACP)|Injection with 4 mls of ACP around the tendon
16065131|NCT02417974|Biological|Fecal Microbiota Transplant (FMT)|Fecal Microbiota Transplant (FMT)
16065132|NCT02417961|Biological|Benralizumab|Benralizumab administered subcutaneously every 4 weeks
16065133|NCT02417948|Other|Written Educational Brochure|Receive brochure with skin cancer education and preventative information
16065134|NCT02417948|Other|Online educational video|Watch 30-minute online tutorial video about skin cancer, preventive behaviors, and skin self-examinations
16065135|NCT02417935|Drug|Duloxetine|Administered orally
16065136|NCT02417935|Drug|Pregabalin|Administered orally
16065137|NCT02417935|Drug|Placebo|Administered orally
16065138|NCT02417922|Other|Saline|4 mls of saline is injected 4 times around the injured tendon area every 2nd week during the 8 weeks of conservative treatment.
16065139|NCT02417922|Other|ACP|4 mls of ACP is injected 4 times around the injured tendon area every 2nd week during the 8 weeks of conservative treatment.
16065140|NCT02417909|Other|questionnaires about quality of life|all teenagers included in the trial and their parents must complete the questionnaires given of them the day of enrollment.
16065141|NCT02417896|Drug|Spironolactone|Spironolactone is administered orally to cardiac surgical patients by a study investigator (100 mg 12-24 hrs before surgery); subsequently three further doses of 25 mg are administered orally in the morning of postoperative days 1, 2 and 3. A total 1 x 100 mg and 3 x 25 mg doses of spironolactone in the intervention group will be given. If the patient has not been extubated, spironolactone is administered nasogastrically. Oral drugs will be delayed by up to 4 hours if extubation has just occurred.
16065142|NCT02417883|Drug|Furosemide|Evaluate urinary excretion rate fo furosemide
16065143|NCT02417870|Biological|aldesleukin|
16065144|NCT02417857|Procedure|Laparoscopic Cholecystectomy (Single Incision)|We performed Single Incision Laparoscopic Cholecystectomy (SILC) operation to the group-1
16065145|NCT02417857|Procedure|Laparoscopic Cholecystectomy (Conventional)|We performed Conventional Laparoscopic Cholecystectomy (CLC) to group-2
16065146|NCT02417844|Drug|tamsulosin (Astellas)|
16065147|NCT02417844|Drug|Tamsulosin HCL|
16065148|NCT02417831|Drug|tamsulosin capsules|
16065149|NCT02417831|Drug|tamsulosin HCl|
16065150|NCT02417818|Device|Plasma Therapy (PlasmaDerm)|Plasma Therapy (PlasmaDerm)
16065151|NCT02417818|Device|Repetitive Plasma Therapy (repetitive PlasmaDerm)|Repetitive Plasma Therapy (Repetitive PlasmaDerm)
16065152|NCT02417805|Procedure|Intervention: Remote Ischemic Preconditioning|Remote Ischemik Preconditioning is performed using a Blood Pressure Cuff with a pressure slightly above patients' blood pressure on the upper arm.
16065153|NCT02417779|Device|Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)|Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
16065154|NCT02417779|Device|Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)|Repetitive Extracorporeal Shock Wave Therapy (Device Name: PiezoWave)
16065155|NCT02417753|Drug|AZD9150|AZD9150 IV infusion over 3 hours Cycle 1: days 1, 3, 5, 8, 15 and 22 of a 28 day cycle. Cycle 2 and beyond Days 1, 8, 15 and 22 of a 28 day cycle
16065156|NCT02417701|Other|Laboratory Biomarker Analysis|Correlative studies
16065157|NCT02417701|Other|Pharmacological Study|Correlative studies
16065158|NCT02417701|Drug|Sapanisertib|Given PO
16065159|NCT02417688|Device|Cu[64]-25%-CANF-Comb PET-MR|Single IV injection of a novel radiopharmaceutical for diagnostic imaging of atherosclerosis by PET-MR
16065160|NCT02417675|Other|Community-based Adherence Clubs|"Women in the AC arm are prescribed 2 months of their current ART medication (compared to 1 month in the SOC) and will be advised to go to the AC office immediately, where they will be scheduled for their first session. Women will attend AC meetings every two months. At these meetings, women will receive a 2 month supply of medication, health education and peer-support. A trained Community Health Worker (CHW) will also collect blood samples, weight, and current signs/symptoms from women.
~Each participant has 5 working days after their AC session to come and collect her medication. Those who have defaulted will be followed up by the CHW via phone calls and, possibly, home visits. If reached, women will be told to return immediately to the main ART facility for receipt of ART care."
16065161|NCT02417675|Other|Standard of Care for Mothers|Women will be referred immediately from the maternity ART clinic to their nearest adult ART clinic at their first postpartum clinic visit. At referral, they receive an initial 1-month supply of their current ART medication. At the first appointment after transfer into the general ART service, patients undergo clinical history and examination by a doctor or clinical nurse practitioner. Laboratory investigations are ordered according to standard protocols or based on clinician discretion. For the 1st 4 months in the new service, stable patients are dispensed 1 month of ART; subsequent visits are 2-monthly for medication refill, with clinician review 6-monthly; patients with particular clinical or psychosocial concerns may be reviewed more regularly, or referred to higher levels of care.
16065162|NCT02417675|Other|Standard of Care for Infants|All infants will receive care at their nearest primary care clinic. Following national protocols, all HIV-infected mothers are issued a 6-week supply of nevirapine syrup after delivery and counselled on daily nevirapine prophylaxis. Infant follow-up takes place within 1 week postpartum with the mother (at the MOU) and then at 6 weeks postpartum (at the nearest primary care clinic) when HIV PCR testing of the infant is carried out. Following national protocols, infants who are breastfed beyond 6 weeks receive HIV PCR testing 2-4 weeks after the cessation of breastfeeding, again conducted at the nearest City of Cape Town primary care clinic.
16065163|NCT02417662|Radiation|Radical Radiotherapy (Conventional RT and SABR)|Radical radiotherapy (conventional or SABR) to primary and SABR to the metastases
16065164|NCT02417662|Other|Non-investigational SACT|There is no intervention in the control group, patients will receive SACT. The choice of SACT is determined by the treating clinician and will be supplied from hospital commercial stock, and prepared and administered according to institutional guidelines.
16065232|NCT02417129|Drug|BI 695500|BI 695500 375 mg/M2
16065233|NCT02417116|Other|Tear supplement|Application as required to improve comfort
16065234|NCT02417116|Other|Tear supplement 2|Application as required to improve comfort
16065235|NCT02417116|Dietary Supplement|Omega 3 nutrition supplement|Taken each day
16065165|NCT02417649|Biological|Placebo|"The placebo will be administered for a period of three months. The first ten days of each month, one tablet per day will be given. The tablet will be melted under the tongue. After the ten day therapy, a twenty day of rest will be provided. Then the second and the third month the administration schedule will be identical.
~Three months of rest, according to the indications, will be allowed.
~A second cycle (the same as point 1.) will be performed
~A second three month rest (according to point 2.) will be provided."
16065166|NCT02417649|Biological|Ismigen|"The tablet will be administered for a period of three months. The first ten days of each month, one tablet per day will be given. The tablet will be melted under the tongue. After the ten day therapy, a twenty day of rest will be provided. Then the second and the third month the administration schedule will be identical.
~Three months of rest, according to the indications, will be allowed.
~A second cycle (the same as point 1.) will be performed
~A second three month rest (according to point 2.) will be provided."
16065167|NCT02417636|Other|Task Shifting|Participants will be screened for eligibility for ART and the study and then enrolled initiated on ART by a Nursing Officers and then followed and monitored for ART adherence on a monthly basis for 12months. Quarterly, sexual behavior and quality of life questionnaires will be administered. CBC, CD4, HIV-1 Viral load, renal and liver function test will be done biannually. Nursing Officers will be free to consult with clinicians on the management of patients.
16065168|NCT02417623|Behavioral|Smartphone Application group|Intervention group will receive a 12-month weight loss programmed that implements recommendations of a Clinical Practice Guideline, complemented with a smartphone app
16065169|NCT02417610|Device|Polynucleotide - PNHA - Newart|gel polynucleotides and hyaluronic acid
16065170|NCT02417610|Device|Hyaluronic acid - HA - Ialart|Hyaluronic acid
16065171|NCT02417597|Biological|Recombinant Hepatitis E Vaccine (Escherichia Coli)|Participants would intramuscularly receive 3 doses of Recombinant Hepatitis E Vaccine (Escherichia Coli) at 0, 1, 6 month.
16065172|NCT02417584|Device|positive airway pressure (PAP)|Positive Airway Pressure (PAP) is a non-invasive machine providing air pressure f to prevent the collapse of the oropharyngeal walls and the obstruction of airflow during sleep, which occurs in obstructive sleep apnea hypopnea syndrome.
16065173|NCT02417571|Device|Ambulatory blood pressure monitoring (ABPM)|24-hour ambulatory BP monitoring using TM-2430 device (A&D Company, Tokyo, Japan)
16065174|NCT02417558|Behavioral|Alterniity Augmented Reality (AAR)|AAR is a patent pending exercise and gaming (exergaming) computer platform with a physical training component (PTC) and a cognitive training component (CTC). It fully immerses a user inside a virtual environment where he is practising complex everyday activities, such as going shopping, using the transportation, visiting a foreign city, eating at a restaurant, cooking dinner etc. His motor behaviour is monitored by means of motion capture, while immersed at this full-body immersion. In addition his cognition is monitored in real-time with Personalized Brain Network Activity (PBNA) screening. Both the motor and brain analyses are then used to update the configuration, type and difficulty of the AAR scenarios.
16065175|NCT02417558|Behavioral|VideoGrade|Active cognitive training by use of the VideoGrade software by Aristotle University of Thessaloniki.
16065176|NCT02417532|Device|Rehabilitation using REX|Exercises of wheelchair dependent subjects using REX
16065177|NCT02417519|Other|DAR|Volunteers ingested 300 mL of coffee with a dark roast containing low levels of chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water
16065178|NCT02417519|Other|LIR|Volunteers ingested 300 mL of coffee with a light roast containing high levels of chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water
16065179|NCT02417519|Other|CTR|Volunteers ingested 300 mL of water containing no chlorogenic acids followed 30 min later by by 75g glucose and 300 mL water
16065180|NCT02417506|Other|E-OA-07 (Lanconone)|
16065181|NCT02417506|Drug|Ibuprofen|
16065182|NCT02417493|Behavioral|Simulation of epinephrine self-injection|
16065183|NCT02417480|Behavioral|Vegan diet|Participants in the omnivorous arm will be asked to follow their normal diet for one week and then follow a vegan diet for one week.
16065184|NCT02417480|Behavioral|Follow habitual, usual diet|Participants will be asked to consume their habitual, usual diet.
16065185|NCT02417467|Other|Nicotine E-Cigarette|
16065186|NCT02417467|Other|Non-Nicotine E-Cigarette|
16065187|NCT02417467|Behavioral|Counseling|
16065188|NCT02417454|Dietary Supplement|ProbioStick|"One sachet daily, without or without meals (3 x 10^9 CFU per sachet)
~(Lactobacillus helveticus R0052 and Bifidobacterium longum subsp. longum R0175)"
16065189|NCT02417454|Other|Placebo|One sachet daily, without or without meals (0 CFU per sachet)
16065190|NCT02417441|Device|Eeva|Embryos of subjects randomized in this group were assessed using Eeva System and morphological grading to identify optimal embryos for transfer.
16065191|NCT02417428|Dietary Supplement|Citrulline|Twelve weeks of citrulline oral supplementation will be taken by half of the participants (other are taken a placebo). Citrulline supplementation will be taken orally. Ten grams of citrulline (white powder) will be mixed with a liquid daily. Supplementation will be consumed once at lunch time.
16065192|NCT02417428|Other|Placebo|Twelve weeks of oral placebo will be taken by half of the participants. Ten grams of placebo (maltodextrin white powder) will be mixed with a liquid and will be consumed once daily at lunch time.
16065193|NCT02417428|Behavioral|Exercise|Participants will also take part in twelve weeks of HIIT (30s at 85% and up of maximal heart rate + 1m30sec at 60-75% of maximal heart rate (HR max). 3 times/ week during 30 continuous minutes. Each period are supervised and monitored using borg scale and polar system.
16065194|NCT02417428|Other|without exercise|No exercise program will be assigned to participants.
16065195|NCT02417415|Other|Passive heat stress|Passive heat stress will be applied with a commercial heating pad that covers all the abdomen and part of the torso to provide local heating at ~44ºC continuously for 2 hr.
16065196|NCT02417415|Other|Control (non-heating)|Heating pad will be applied over the abdomen and part of the torso but it will be turned off.
16065197|NCT02417402|Other|Control|The patients allocated to the Control group will be treated by physical therapists who did not carry out the training before treatment. The physical therapists will use their usual care for nonspecific chronic low back pain. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week). Each treatment session has an estimated duration of 50-60 minutes.
16066064|NCT02411448|Drug|Gefitinib|Administered orally.
16065198|NCT02417402|Other|Trained|The patients allocated to the Experimental group will be treated by physical therapists who carried out the training before treatment. The training will be designed to guide the physical therapists beliefs and attitudes to a biopsychosocial model; update knowledge contained in clinical practice guidelines; and enable physical therapists to identify, integrate and address psychosocial factors in patients with nonspecific chronic low back pain. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week). Each treatment session has an estimated duration of 50-60 minutes.
16065199|NCT02417389|Drug|cinacalcet|During Phase 1 (months 1-12): oral administration; 30 mg twice/day (dose to be increased if needed).
16065200|NCT02417389|Drug|Alendronate|During Phase 2 (months 13-24): oral administration; 70 mg once/week (in addition to cinacalcet 30 mg twice/day as during Phase 1).
16065201|NCT02417376|Device|piezoelectric ultrasonic scaler (frequency of 28-36 KHz)|Periodontal treatment in the form of scaling and root planing (SRP) is provided to the patients assigned to the experimental group, after baseline examination. Scaling is performed using piezoelectric ultrasonic scaler (frequency of 28-36 KHz) and root planing is performed using area specific Gracey curettes (set of 7 instruments number #1-14). SRP is completed in two appointments of 45 min to 1 hour, within 24 hours period.
16065202|NCT02417376|Device|Gracey curettes|set of 7 instruments number #1-14
16065203|NCT02417350|Other|Ketogenic diet for four weeks, then a 15 week washout, and finally a NFA recommended diet for four weeks|
16065204|NCT02417350|Other|NFA recommended diet for four weeks, then a 15 week washout, and finally a ketogenic diet for four weeks.|
16065205|NCT02417337|Procedure|Root Canal Treatment|A standardized endodontic procedures performed.
16065206|NCT02417337|Drug|Paracetamol|
16065207|NCT02417337|Drug|Ibuprofen|
16065208|NCT02417337|Drug|Mefenamic acid|
16065209|NCT02417337|Drug|Diclofenac|
16065210|NCT02417311|Other|Skin biopsy, genotyping and disease phenotyping|Major steps of the project are (i) in depths clinical phenotyping and follow-up of the clinical course of probands (ii) genotyping of candidate genes involved in heart disease development and (iii) in vitro functional tests of engineered heart tissue (EHT), miniature beating heart muscles. These EHTs are generated from hiPSC (human induced pluripotent stem cells) lines derived from skin biopsies of each participant.
16065211|NCT02417298|Drug|Normal saline|Normal saline intravenous push (with volume to be administered equivalent to that of ketamine 0.3mg/kg, if the patient was to receive ketamine) followed by a normal saline infusion at the same rate as ketamine arm
16065212|NCT02417298|Drug|Ketamine|0.3mg/kg IVP ketamine followed by 0.1mg/kg/hr of ketamine infusion for 3 hours
16065215|NCT02417272|Device|Surgical treatment of cervical degenerative disc disease (CP ESP®)|
16065216|NCT02417272|Device|Surgical treatment of cervical degenerative disc disease (Axelle®)|Axelle®
16065217|NCT02417246|Drug|brand name metoprolol ER|This medication will be taken for 7 to 28 days
16065218|NCT02417246|Drug|Generic A|This medication will be taken for 7 days
16065219|NCT02417246|Drug|Generic B|This medication will be taken for 7 days
16065220|NCT02417233|Behavioral|SMS text message|bi-weekly behavioral messages and bi-weekly check-in messages
16065221|NCT02417233|Behavioral|SMS text message + Peer Navigation|bi-weekly behavioral messages plus personalized peer navigation
16065222|NCT02417220|Behavioral|Weight Watchers Online 2015 Program|Access to the Weight Watchers Online 2015 program available via the Internet on personal computers, tablet computers, and/or smartphones already owned by participants.
16065223|NCT02417220|Other|Electronic Scale with Feedback|Provision of an electronic scale that automatically transmits body weights to the Weight Watchers Online 2015 program, which generates a weekly feedback message on weight loss progress.
16065224|NCT02417207|Drug|Entecavir combined long-term low-dose HBIG group intramuscular|HBIG scheme is: the use of intraoperative muscle injection of 800 IU HBIG, postoperative week 1 intramuscular injection HBIG 400 IU 1 times a day, 1 week after intramuscular injection HBIG 400 IU 2 times per week, dosage and time interval according to the HBsAb drops in patients with degree of level adjustment, target drops for 3 months or more after 500 IU/mL, 3 ~ 6 months or 300 IU/mL, after six months of 100 IU/mL or more.
16065225|NCT02417207|Drug|Entecavir combined HBIG group short-term high-dose intravenous|Preoperative HBV DNA level is less than 1000 IU/ml, intraoperative intravenous drip of 2500 IU HBIG static note type, postoperative 1 and 15 days respectively to give 2500 IU HBIG static note type, a total of three times, then no longer apply. Preoperative HBV DNA level greater than 1000 IU/ml, the use of HBIG solution for: intraoperative intravenous drip of 5000 IU HBIG static note type, postoperative day 1, 15 days and 30 days respectively to give 2000-2500 IU HBIG static note type, a total of four times, since then no longer apply. Preoperative HBV DNA level of the unknown, preoperative immediate detection of DNA, intraoperative intravenous drip of 5000 iu HBIG static note type, choose according to test results after dosing frequency.
16065226|NCT02417181|Other|Care provided by Physician Assistants|Patients will receive care at the out-of-hours primary care service by a Physician Assistant instead of a General Practitioner (substitution of care from physicians to nurses).
16065227|NCT02417155|Behavioral|Hyper/hypoventilation|"Subjects are asked to hyperventilate for an average of 30 breaths. Subsequently, the subjects exhaled and hold their breath for approximately 2 minutes (retention phase). The duration of breath retention will be entirely at the discretion of the subject himself. Breath retention is followed by a deep inhalation breath, that will be held for 10 s. Subsequently a new cycle of hyper/hypoventilation begins."
16065228|NCT02417155|Behavioral|Strength ventilation|This exercise consists of deep inhalations and exhalations in which every inhalation and exhalation is followed by breath holding for 10 s, during which the subject tightens all his body muscles.
16065229|NCT02417142|Drug|Exenatide|Exenatide SQ 2mg/week for 24 weeks.
16065230|NCT02417142|Drug|Placebo|Placebo SQ 1x/week for 24 weeks.
16065231|NCT02417129|Drug|Rituximab|BI 695500 375 mg/M2
16065236|NCT02417116|Device|Eye bag|Applied following microwave heating to closed eyelids for 5 minutes each day
16065237|NCT02417116|Other|Saline|Application as required to improve comfort
16065238|NCT02417103|Drug|GLP-1 (Liraglutide)|GLP-1 Analogon
16065239|NCT02417103|Drug|Placebo|Placebo
16065240|NCT02417090|Drug|Insulin|Pregnant women who used insulin to treat gestational diabetes
16065241|NCT02417090|Drug|Metformin|Pregnant women who used metformin to treat gestational diabetes
16065242|NCT02417077|Other|Photographic Review|Photographic review of subjects who received treatment with onabotulinumtoxinA for crow's feet lines.
16065243|NCT02417064|Drug|Esketamine|Participants will self-administer either 84 mg or 56 mg of esketamine, intranasally, twice per week for 4 weeks as a fixed dose regimen in Double-Blind Induction Phase.
16065244|NCT02417064|Drug|Placebo|Participants will self-administer matching placebo, intranasally, twice per week for 4 weeks as a fixed dose regimen in Double-Blind Induction Phase.
16065245|NCT02417064|Drug|Duloxetine (Oral Antidepressant)|Duloxetine could be selected as the oral antidepressant medication by the investigator based on review of Massachusetts General Hospital - Antidepressant Treatment Response Questionnaire (MGH-ATRQ) and relevant prior antidepressant medication information. The minimum therapeutic dose is 60 milligram per day (mg/day).
16065246|NCT02417064|Drug|Escitalopram (Oral antidepressant)|Escitalopram could be selected as the oral antidepressant medication by the investigator based on review of MGH-ATRQ and relevant prior antidepressant medication information. Escitalopram will be titrated up to a dose of 20 mg/day, but if not tolerated the dose can be reduced to the minimum therapeutic dose of 10 mg/day.
16065247|NCT02417064|Drug|Sertraline (Oral Antidepressant)|Sertraline could be selected as the oral antidepressant medication by the investigator based on review of MGH-ATRQ and relevant prior antidepressant medication information. Sertraline will be titrated up to a dose of 200 mg/day, but if not tolerated the dose can be reduced to the minimum therapeutic dose of 50 mg/day.
16065248|NCT02417064|Drug|Venlafaxine Extended Release (XR) (Oral Antidepressant)|Venlafaxine Extended Release could be selected as the oral antidepressant medication by the investigator based on review of MGH-ATRQ and relevant prior antidepressant medication information. Venlafaxine Extended Release will be titrated up to a dose of 225 mg/day, but if not tolerated the dose can be reduced to the minimum therapeutic dose of 150 mg/day.
16065249|NCT02417051|Behavioral|Disaster Worker Resiliency Training|The Disaster Worker Resilience Training (DWRT) Program is a 4 hour program which consists of a participant training manual, an instructor-training manual, and a digital presentation. It uses adult training techniques that emphasize active participation in individual and group experiential learning activities. The curriculum is organized into a preface and four chapters, each with action oriented learning objectives. Overall program objectives include a demonstrate an ability to: 1) Recognize signs and symptoms of disaster work-related stress, 2) Obtain support through employer and community resources, and 3) Build resilience by using stress reduction and coping strategies.
16065250|NCT02417038|Device|Capnostream|The Capnostream capnograph (is registered with the FDA) is supplied by Covidien. The Capnostream is a portable CO2 monitor with a pulse oximetry module to measure and record SpO2 (oxygen saturation) and heart rate continuously. The Capnostream provides waveform patterns for respiratory rate and EtCO2 measurement.
16065251|NCT02417025|Behavioral|PE|Prolonged Exposure
16065252|NCT02417012|Behavioral|U-TURN|Participants in this group will receive individual and group based interventions on obtaining and maintaining a healthy lifestyle, while having the pharmacological treatment regulated
16065253|NCT02417012|Behavioral|Standard care|Standard individual diabetes support
16065254|NCT02416999|Drug|Ultra-low dose Bevacizumab|
16065255|NCT02416999|Drug|Temozolomide|
16065256|NCT02416986|Behavioral|6 hour smoking abstinence|
16065257|NCT02416986|Behavioral|Delay to Smoking Task (smoking cues)|Participants will be presented with an unlit cigarette of their brand and an opportunity to initiate ad lib smoking at any time during the 60-minute task. During this period, participants will be allowed to read books or magazines, but will hear a tone alerting them to view cues (standard smoking environments) for the final minute of each 6-minute period. A monetary reinforcer will be provided for each 6-minute period that a participant resists smoking. Once participants stop the task they can choose to smoke as much or a little as they want for the next 30 minutes. Participants will be provided with a smoking tab. Each cigarette they light will cost them from their tab.
16065258|NCT02416986|Behavioral|Delay to Smoking Task (nonsmoking cues)|Participants will be presented with an unlit cigarette of their brand and an opportunity to initiate ad lib smoking at any time during the 60-minute task. During this period, participants will be allowed to read books or magazines, but will hear a tone alerting them to view cues (standard nonsmoking environments) for the final minute of each 6-minute period. A monetary reinforcer will be provided for each 6-minute period that a participant resists smoking. Once participants stop the task they can choose to smoke as much or a little as they want for the next 30 minutes. Participants will be provided with a smoking tab. Each cigarette they light will cost them from their tab.
16065259|NCT02416973|Device|Provant|
16065260|NCT02416960|Other|Low Glycemic Index Diet Group|This diet will be designed as a moderate reduced-energy, moderate-to-high ﬁber, low glycemic index/load diet.
16065261|NCT02416960|Other|Conventional Diet Group|This diet will be designed as a moderate reduced-energy, moderate-to-high ﬁber, high glycemic index/load diet.
16065262|NCT02416947|Dietary Supplement|0 g SCF|0 grams of SCF will be administered daily in two equal doses in the form of a muffin and a drink.
16065263|NCT02416947|Dietary Supplement|10g SCF|10 grams of SCF will be administered daily in two equal doses in the form of a muffin and a drink.
16065264|NCT02416947|Dietary Supplement|20g SCF|20 grams of SCF will be administered daily in two equal doses in the form of a muffin and a drink.
16065265|NCT02416934|Drug|Treatment 1; Dexamethasone|Dexamethasone IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.
16065266|NCT02416934|Drug|Treatment 0; Saline placebo|Saline (placebo) IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.
16065267|NCT02416921|Behavioral|Weight-gain Prevention|A 4-week weight-gain prevention curriculum will be delivered via Facebook. Participants will be provided tips to prevent weight-gain and will be given the opportunity to engage with the peer coaches and other participants in the group.
16065268|NCT02416921|Behavioral|Women's Health|A 4-week women's health curriculum will be delivered via Facebook. Participants will be provided tips for staying healthy and will be given the opportunity to engage with the peer coaches and other participants in the group.
16065269|NCT02416908|Drug|Selinexor|
16065270|NCT02416908|Drug|Cladribine|
16065271|NCT02416908|Drug|G-CSF|
16065272|NCT02416908|Drug|Cytarabine|
16065273|NCT02416908|Procedure|Bone marrow biopsy|
16065274|NCT02416895|Other|In vivo immunity model|A measure of in vivo immune function.
16065275|NCT02416882|Other|Aerobic Exercise|Subjects will sample and rate their liking of three cardiovascular machines (treadmill, cycle ergometer, elliptical step ergometer) to determine which one will be used during the test.
16065276|NCT02416882|Other|Resistance Exercise|Subjects will sample and rate their liking of three different resistance training circuits (upper body, lower body, core) to determine which one will be used during the test.
16065277|NCT02416882|Other|Sedentary Option|Subjects will rate their liking of three sedentary activities (reading magazines, playing puzzles, completing word games) as an alternative to exercise.
16065278|NCT02416869|Procedure|Intramuscular application|Patient receive 4mg of Dexamethasone by intramuscular application
16065279|NCT02416869|Procedure|Submucosal application|Patients receive 4mg of Dexamethasone by submucosal application
16065280|NCT02416869|Drug|4mg Dexamethasone submucosal|Patients receive 4mg of submucosal Dexamethasone
16065281|NCT02416869|Drug|8mg Dexamethasone submucosal|Patients receive 8mg of submucosal Dexamethasone
16065282|NCT02416869|Procedure|4mg Dexamethasone preoperative|Patients receive 4mg of Dexamethasone preoperatively
16065283|NCT02416869|Procedure|4mg Dexamethasone postoperative|Patients receive 4mg of Dexamethasone postoperatively
16065284|NCT02416843|Other|Consumption of a mixed meal|Participants will consume a mixed meal and postprandial responses in blood and adipose tissue will be investigated over 6 hours and compared to baseline.
16065285|NCT02416817|Other|Blood Products only|Based solely on massive transfusion triggers Patients with traumatic hemorrhage that fulfil the inclusion criteria will receive blood products by prescription of the patient's anesthesiologist. The patient will be constantly observed and bleeding triggers will be reassessed hourly.
16065286|NCT02416817|Other|Point of Care guided|Based on massive transfusion triggers and thromboelastometry Patients with traumatic hemorrhage that fulfil the inclusion criteria will receive the drugs guided by the results of the thromboelastometry. The dosis of each drug will be based on the analysis of the thromboelastometry curves (established algorithm).
16065287|NCT02416804|Drug|Buprenorphine|Buprenorphine transdermal patch Initial : 5 μg/hr Sequential increasing of dose : 5 μg/hr -> 10 μg/hr -> 15 (5+10) μg/hr -> 20 μg/hr
16065288|NCT02416804|Drug|Tramadol|Tramadol Initial : 150 mg/d Sequential increasing of dose : 150 mg/d -> 200 mg/d -> 250 mg/d -> 300 mg/d
16065289|NCT02416791|Device|Robotic Therapy|Robotic therapy (MIT - Manus, Interactive Motion Technologies) will be administered for 40 minutes to the paretic upper limb.
16065290|NCT02416791|Device|Active tDCS|Active tDCS will be applied with the cathode positioned over the ipsilesional primary motor cortex and the anode over the contralateral supraorbital region for 20 minutes (1mA).
16065291|NCT02416791|Device|Sham tDCS|In sham tDCS, no current will be delivered through the tDCS device.
16065292|NCT02416791|Other|Physical Therapy|Physical therapy will be administered for 40 minutes.
16065293|NCT02416791|Other|Occupational Therapy|Occupational therapy will be administered for 40 minutes.
16065294|NCT02416778|Drug|Ferric carboxymaltose, Ferinject® 50mg Iron/ml Solution for Injection / Infusion|
16065295|NCT02416765|Other|15-hour intervention|Interventions will be conducted in outpatient settings. Subject's usual insulin will be used. Meals will not be standardized. Subjects will be allowed to eat whatever and when they want and will be allowed to drink alcohol. Subjects will be allowed to exercise, but they will be asked to do the same amount and intensity of exercise on all intervention visits. Subjects will be accompanied all the time by a member from the research team during closed-loop visits to implement hormonal infusions.
16065296|NCT02416765|Drug|Insulin (Lispro, Aspart or guilisine)|Patient's usual insulin (Lispro, Aspart or guilisine) will be used in all interventions.
16065297|NCT02416765|Drug|Glucagon (Eli Lilly)|In the dual-hormone CLS interventions, glucagon (Eli Lilly) will be used.
16065298|NCT02416765|Other|Closed-loop strategy|Every 10 minutes, the glucose level as measured by the real time sensor (Dexcom G4 Platinum, Dexcom) will be entered manually into the computer. The pumps' infusion rate will then be changed manually based on the computer generated recommendation infusion rates. The computer generated recommendations are based on a predictive algorithm.
16065299|NCT02416752|Drug|Remifentanil|The remifentanil infusion was used intra operatively in remifentanil group and intermittent boluses of morphine or fentanyl administered for conventional opioid group
16065300|NCT02416752|Drug|choice of intra-operative opioids were left to the discretion of anesthesiologist|
16065301|NCT02416739|Drug|Nicotinamide|Nicotinamide (1g/day) or placebo treatment is added to the standard drug treatment (gefitinib or erlotinib) to EGFR mutated NSCLC patients
16065302|NCT02416726|Device|Nextseq500 sequencer|The sequencer will be used to detect the gene mutations of the primary tumor, metastatic LN and peripheral blood samples obtained from patients.
16065303|NCT02416713|Device|Cellcontrol DriveID|Technology that blocks incoming and outgoing calls and texts.
16065304|NCT02416713|Other|Education Only|No active intervention, educational materials will be provided
16065305|NCT02416700|Procedure|immediate implant surgery|Surgery of dental implants in one side of the mouth.
16065306|NCT02416700|Device|implant surgery (Straumann®)|Dental implant surgery in one of the sides of the mouth
16065307|NCT02416687|Device|Implanon®|Postpartum women into whom the etonogestrel-releasing contraceptive implant was inserted in the first 48 h postpartum
16065308|NCT02416674|Procedure|abdominal wall transplantation|transfer of abdominal wall tissues from an organ donor to a pacient with a large abdominal wall defect.
16065309|NCT02416674|Drug|Immunosuppressive Agents|Recipients of abdominal wall transplants will need to receive global immunosuppression with tacrolimus, mycophenolate mofetil and prednisone.
16065428|NCT02415881|Drug|Panitumumab IRDye 800|Patients will receive Panitumumab IRDye 800 prior to their scheduled surgery
16065310|NCT02416648|Behavioral|Clinician Client Centered (CCC) Counseling|"Counseling sessions were interactive allowing for listening, questions and answers. They were cultural sensitive and also consider issues related to gender and age. Areas covered during the brief counseling included; HIV transmission and prevention, healthy sexual practices, condom use, reduction in multiple sexual partners, beneficial disclosure, and individual risk assessment and reduction strategies.
~Clinicians evaluated patients' readiness to change risky or maintain safer behaviors. They also assisted the patient to negotiate an individually tailored behavior change or maintenance plan of action."
16065311|NCT02416635|Other|Flow cytometry (FCM)|Use FCM to test PBMCs/CTCs from volunteers/patients.
16065312|NCT02416635|Other|RT-PCR|Use RT-PCR to test PBMCs/CTCs from volunteers/patients.
16065313|NCT02416622|Biological|rAAV2tYF-CB-hRS1|adeno-associated virus vector expressing retinoschisin
16065314|NCT02416609|Radiation|LDR|LDR will be delivered during each cycle of Gem-based doublets
16065315|NCT02416609|Drug|Gem-based doublets|4 cycles of Gem-based doublets
16065316|NCT02416609|Radiation|SBRT|SBRT will be administered after the fourth Gem-based doblet cycle, if no progression; three fractions will be administered
16065317|NCT02416596|Procedure|Hysteroscopy|"Office hysteroscopy will be performed during the Luteal phase of the proceeding menstrual cycle.
~All OH (office hysteroscopy) procedures will be performed with a vaginoscopic approach without utilizing a speculum and applying traction to the cervix with a tenaculum.
~Antibiotic prophylaxis: None OH will be cancelled until after treatment of vaginal infection."
16065318|NCT02416596|Device|Hysteroscope|"The device used is a rigid hysteroscope (continuous flow, 30 degree forward oblique view) assembled in a 4-mm diameter diagnostic sheath with an atraumatic tip (Karl Storz Endoscopy).
~Illumination: High intensity cold light source and fiberoptic cable Distention medium: solution of 0.9% normal saline with pressure at 100-120 mmHg"
16065319|NCT02416583|Drug|Oxytocin|
16065320|NCT02416583|Drug|Dinoprostone|
16065321|NCT02416583|Procedure|Membrane sweeping|
16065322|NCT02416570|Drug|Clarithromycin|
16065323|NCT02416570|Drug|Placebo|
16065324|NCT02416557|Procedure|PEEP|application of 10 cmH2O (centimeter of water) positive end expiratory pressure during mechanical ventilation
16065325|NCT02416544|Other|Lunch which is calorie-restricted and low-salt|Comparison of different duration of feeding lunch which is calorie-restricted and low-salt
16065326|NCT02416531|Drug|Clobetasol propionate|Clobetasol propionate 0.05% ointment applied once daily at a dose of 1 g/application (1 g sachets) for 4 weeks.
16065327|NCT02416531|Radiation|Photodynamic therapy|Methylene blue 0.01% intralesional, λ = 660 ± 10 nm, P = 100 mW, PD = 510 mW/cm2, E = 4 J, ED = 20 J/cm2, t = 40 s, once a week for 4 weeks
16065328|NCT02416531|Radiation|Low level laser therapy|λ = 660 ± 10 nm, P = 100 mW, PD = 510 mW/cm2, E = 4 J, ED = 20 J/cm2, t = 40 s, once a week for 4 weeks
16065329|NCT02416505|Behavioral|Verbal+Anatomic Model|
16065330|NCT02416505|Behavioral|Verbal+Video|
16065331|NCT02416492|Biological|SB623 cells|SB623 cells will be implanted in the peri-infarct area using stereotactic surgery.
16065332|NCT02416492|Procedure|Sham Control|Sham Surgery (Partial burr hole only)
16065333|NCT02416479|Behavioral|SystemCHANGE|SystemCHANGE self-management supports patient-designed, interventionist-guided, small experiments using Deming's Plan-Do-Check-Act cycle26 to: (1) assess individual systems (including important others who shape medication taking), how they influence medication taking and their proposals for improving medication adherence, (2) implement the proposed individual systems' solutions to improve adherence, (3) track adherence data, and (4) evaluate adherence data.
16065334|NCT02416479|Behavioral|Patient-education attention control|The 6-month Patient education attention-control (AC) intervention includes 6 transplant educational materials, covering healthy post-transplant behavior, developed by the International Transplant Nurses Society. The RA calls Pps at 1, 2, 3, 4, 5 and 6 months to review the brochure information and answer any questions about it.
16065335|NCT02416466|Biological|anti-CEA CAR-T cells|Gene modified patient T cells.
16065336|NCT02416466|Device|Sir-Spheres|SIR-Spheres microspheres are a medical device used in Selective Internal Radiation Therapy (SIRT) for liver tumors. SIR-Spheres microspheres are a permanent implant and for single use only. The biocompatible resin microspheres containing yttrium-90 have a median diameter of 32.5 microns (range between 20 and 60 microns).
16065337|NCT02416453|Biological|MVA-BN-Filo|One 0.5 mL intramuscular (IM) injection of 1E8 Infectious Unit [Inf. U.] on Day 29, 57, or 85.
16065338|NCT02416453|Biological|Ad26.ZEBOV|One 0.5 mL IM injection of 5E10 viral particles (vp) on Day 1.
16065339|NCT02416453|Biological|Placebo|One 0.5 mL IM injection of 0.9% saline on Day 1 and Day 29, 57, or 85.
16065340|NCT02416440|Other|blood sample|blood sample
16065341|NCT02416427|Drug|Atorvastatin|Atorvastatin will be administered at 80 mg/day for 3 weeks in the time window between diagnostic biopsy and curative surgery
16065342|NCT02416414|Device|QuantiFERON Monitor Assay|Assay to measure cell-mediated immune function using QuantiFERON Monitor assay.
16065343|NCT02416414|Device|Existing methodology|Assay to measure cell-mediated immune function using existing methodology.
16065344|NCT02416401|Other|Computerized Plasticity-Based Adaptive Cognitive Training|
16065345|NCT02416401|Other|Commercially available computerized training|
16065346|NCT02416388|Drug|Idarubicin|"Induction chemotherapy :
~Idarubicin 9mg/m² /day, from D1 to D5 (IV, 30min)
~+ cytarabine 200mg/m²/day from D1 to D7 (IV 24 h)
~Bone marrow aspirate on D15 : if medullary blasts rate < 5% → G-CSF (5 μg/kg/day) until hematopoietic recovery (PNN ≥ 1 G/L)."
16065347|NCT02416388|Drug|Daunorubicin|"Induction chemotherapy :
~Daunorubicin 90mg/m²/day, from D1 to D3 (IV, 30min)
~+ cytarabine 200mg/m² /day from D1 to D7 (IV 24 h)
~Bone marrow aspirate on D15 : if medullary blasts rate < 5% → G-CSF (5 μg/kg/day) until hematopoietic recovery (PNN ≥ 1 G/L)."
16065348|NCT02416388|Drug|HD Cytarabine|"Consolidation chemotherapy course (s) :
~-High dose cytarabine: 3g/m² /12h on D1, D3 and D5
~For all patients, G-CSF (5 μg/kg/day) : SC or IV (30 min) from D8 until hematopoietic recovery (PNN ≥ 1 G/L)
~Up to 3 consolidation courses, depending on the patient AML risk group"
16065349|NCT02416388|Drug|Cyclosporine|"GvHD prophylaxis post allogeneic SCT :
~-Cyclosporine : 3 mg/kg /day from D-1 (IV) or 6 mg/kg/day from D-3 (PO). Not to be stopped before D100"
16065350|NCT02416388|Drug|Methotrexate|"GvHD prophylaxis post allogeneic SCT :
~-15 mg/m² on D+1 then 10 mg/m² on D+3, D+6 and D+11"
16065351|NCT02416388|Drug|Mycophenolic acid (MPA)|"GvHD prophylaxis post allogeneic SCT :
~720 mg BID from D0 to D+28 for HLA-identical siblings
~720 mg BID from D0 to D+45 for 10/10 HLA allele-matched unrelated donors"
16065352|NCT02416388|Drug|vosaroxin|"Consolidation chemotherapy course (s) :
~-70 mg/m² on D1 and D4"
16065353|NCT02416388|Drug|ID cytarabine|"Consolidation chemotherapy course (s) :
~-Intermediate dose cytarabine: 1.5g/m² /12h on D1, D3 and D5
~For all patients, G-CSF (5 μg/kg/day) : SC or IV (30 min) from D8 until hematopoietic recovery (PNN ≥ 1 G/L)
~Up to 3 consolidation courses, depending on the patient AML risk group"
16065354|NCT02416388|Drug|Dexamethasone|"Consolidation chemotherapy course (s) :
~-10 mg/12h on D1, D3 and D5"
16065355|NCT02416388|Drug|Venetoclax|"Consolidation chemotherapy course (s) :
~Once RP2D has been determined from the results of the dose selection phase (phase 1), the optimal dose level retained for randomized phase 2 will be one of the following:
~100 mg/d on D1 to D8 (selection phase dose level 1)
~or 200 mg/d on D1 to D8 (selection phase dose level 2)
~or 400 mg/d on D1 to D8 (selection phase dose level 3)
~or 400 mg/d on D1 to D14 (selection phase dose level 4)"
16065356|NCT02416362|Other|Vibration at 30 Hz|During the exercise protocol, the vibration platform will be turned on at a vibration frequency of 30 Hz.
16065357|NCT02416362|Other|Vibration at 50 Hz|During the exercise protocol, the vibration platform will be turned on at a vibration frequency of 50 Hz.
16065358|NCT02416349|Other|Respiratory Muscles Stretching|"Respiratory Muscles Stretching The stretching will occur throughout the expiratory phase to allow respiratory muscles to reach their maximal length, and two sets with 10 consecutive incursions will be use for each stretching pattern with an interval of 30 seconds between series.
~Pattern 1: Neck stretching Pattern 2: Upper chest stretching Pattern 3:Pectoralis major stretching Pattern 4:Lateral chest stretching"
16065359|NCT02416349|Other|Control Group|Control Group - all volunteers will be positioned at rest in a comfortable in a chair during 20 minutes.
16065360|NCT02416336|Device|Sentinella Intraoperative imaging protocol|"There is a holding time of 15-20 minutes after the lymph node is removed during which the node is further dissected, examined and prepared for pathological analysis. This occurs before the procedure is completed in case the surgeon determines that further surgical exploration or tissue removal is required.
~In this study, the investigators will use this holding time to collect images of the sentinel lymph node area using the Sentinella camera for this study. Therefore, participation in this study will not increase the subject's overall procedure time. However, if the Sentinella camera detects something that the standard imaging techniques have missed, such as an additional sentinel node, the surgeon will do further exploration and tissue removal as needed."
16065361|NCT02416323|Other|AIM HI Training|
16065362|NCT02416310|Device|TEAS|According to ancient Chinese medical books, acupoints SP6 and ST36 are chosen and identified.The patients in TEAS group received electrical stimulation with the 'disperse-dense' waves. Non-acupoint is located 2cm interior to the ST36 and SP6.For group TEAS and Sham, TEAS will be administered 30 minutes prior to surgery and continued until the end of the surgery.Control patients will receive the same treatment without electrical stimulation.
16065363|NCT02416297|Procedure|Micro-osteoperforation|Flapless cortical perforations will be made 8 months minimum after dental extraction. Surgical protocol will be flapless to preserve periodontal health. After local anesthesia, 3 micro osteoperforations will be done with manual instrument, between apex to the contour of free gum between the canine and second pre-molar. Perforations near each tooth will have 6-8 mm depth
16065364|NCT02416284|Other|NFBDG|"Intervention consists of:
~Lecture presenting the NFBDG, Printed booklet containing the NFBDG, Suggested meal plan for a week, Recipes, Access to a restricted website with further information on the NFBDG, A Facebook-group where Vegetable of the day was presented with a suggested recipe, text-messages with encouragement to follow the guidelines, follow-up phone-calls, common exercise sessions, Free common meals (1 breakfast, 2 lunches, 1 dinner), Free foods (low-fat dairy products, a juice containing grapes, blueberries, chokeberries, and cherries and fruits)"
16065365|NCT02416271|Drug|Teriparatide|Administered SC
16065366|NCT02416271|Drug|Alendronate|Administered orally
16065367|NCT02416271|Dietary Supplement|Calcium|Administered orally
16065368|NCT02416271|Dietary Supplement|Vitamin D|Administered orally
16065369|NCT02416271|Drug|Placebo-Oral|Administered orally
16065370|NCT02416271|Drug|Placebo-SC|Administered SC
16065371|NCT02416258|Drug|LP0113 aerosol spray|
16065372|NCT02416258|Drug|Aerosol spray vehicle|
16065373|NCT02416258|Drug|LEO 90100 aerosol foam|
16065374|NCT02416258|Drug|Betamethasone dipropionate aerosol spray|
16065375|NCT02416258|Drug|Calcipotriol aerosol spray|
16065376|NCT02416258|Drug|Daivobet® gel|
16065377|NCT02416245|Dietary Supplement|Beverage powder fortified with micronutrients and Bacopa monnieri extract|Test beverage powder is fortified with micronutrients and Bacopa monnieri extract. Each sachet contains 32g of treatmemt product and 6g dairy whitener. Entire content of the sachet will be stirred with 180mL of potable lukewarm water, and given orally twice daily
16065378|NCT02416245|Other|Non fortified isocaloric control (without added micronutrients and Bacopa monnieri extract)|Control beverage powder is the non-fortified isocaloric powder i.e. without micronutrients and Bacopa Monnieri extract. Each sachet contains 32g of placebo product and 6g dairy whitener. Entire content of the sachet will be stirred with 180mL of potable lukewarm water, and given orally twice daily
16065379|NCT02416232|Drug|Trametinib|Trametinib will be provided as tablets containing 0.5 milligram (mg) or 2.0 mg of trametinib parent (present as the DMSO solvate). The starting dose of trametinib will be administered orally 2.0 mg, once daily (QD)
16065380|NCT02416232|Drug|Dabrafenib|Dabrafenib is commercially available as capsules containing 50 mg or 75 mg as free base (present as the mesylate salt). Dabrafenib will be administered orally 150 mg, twice daily (BID).
16065381|NCT02416219|Procedure|Cricoid pressure|participants will ask to mark the place where they will apply cricoid pressure if the patients was undergoing rapid sequence induction. US will be used to confirm how accurate they are in their estimation.
16065382|NCT02416219|Device|Ultrasound|
16065383|NCT02416206|Drug|BeEAM|BeEAM
16065384|NCT02416193|Drug|Cholecalciferol|Participants will take randomly assigned high dose cholecalciferol once weekly for three months
16065385|NCT02416193|Drug|Cholecalciferol|Participants will take randomly assigned active comparator cholecalciferol once weekly for three months
16065386|NCT02416180|Device|SERETIDE MDI|Commercially available SERETIDE MDI (EVOHALER) containing fluticasone propionate/salmeterol. Subjects will use MDI as 2 inhalations twice daily at the dose equivalent to their usual maintenance treatment of SERETIDE via DISKUS Inhaler.
16065387|NCT02416180|Device|Placebo DISKUS Inhaler|Placebo dry powder inhaler to be used to demonstrate the use of DISKUS inhaler at Visit 1
16065388|NCT02416180|Device|Placebo MDI|Clear liquid propellant inhaler to be used to demonstrate the use of MDI at Visit 2
16065389|NCT02416167|Drug|FYU-981|
16065390|NCT02416167|Drug|Placebo|
16065391|NCT02416154|Procedure|Reproductive tract and blood sampling|Reproductive tract and blood sampling will be performed at enrollment only in this cross-sectional parallel cohort study.
16065392|NCT02416141|Drug|fast release oro dispersible tramadol 50 mg|idem arm 1
16065393|NCT02416128|Drug|Euphrasia|1 drop in the treated eye QID X 10 days
16065394|NCT02416128|Drug|Prednisolone acetate|1 drop in the treated eye QID X 10 days
16065395|NCT02416115|Drug|Ramosetron|Ramosetron was given iv.
16065396|NCT02416115|Drug|Naloxone|Naloxone added to PCA was given iv.
16065397|NCT02416115|Drug|saline|Saline was given iv.
16065398|NCT02416115|Drug|Morphine|Morphine in the PCA was given iv.
16065399|NCT02416102|Drug|Losartan 50 mg|50 mg Losartan taken orally once daily for 4 consecutive weeks.
16065400|NCT02416102|Drug|Losartan 100 mg|50 mg Losartan taken orally twice daily for 4 consecutive weeks.
16065401|NCT02416089|Device|Tampostat|
16065402|NCT02416089|Device|Condom catheter tamponade|
16065403|NCT02416076|Device|Ulthera Treatment at EL2|Focused ultrasound energy delivered below the surface of the skin.
16065404|NCT02416076|Device|Ulthera Treatment at EL4|Focused ultrasound energy delivered below the surface of the skin.
16065405|NCT02416063|Drug|Caudal Dexmedetomidine|"Drug:Caudal bupivacaine 0.25% 1ml/kg
~Drug: Caudal dexmedetomidine 1µg/kg
~Intravenous: 10 ml normal saline
~sevoflurane Induction and maintenance of anesthesia"
16065406|NCT02416063|Drug|Intravenous dexmedetomidine|"Drug:Caudal bupivacaine 0.25% 1ml/kg.
~Drug:Intravenous dexmedetomidine1 μg /kg in a total volume of 10 ml
~sevoflurane Induction and maintenance of anesthesia"
16065407|NCT02416063|Drug|Placebo|"Drug:Caudal bupivacaine 0.25% 1ml/kg
~Intravenous: Normal saline 10 ml
~sevoflurane Induction and maintenance of anesthesia"
16065408|NCT02416050|Procedure|Brain MRI imagery|Brain MRI performed during the first week of inpatient cocaine cessation
16065409|NCT02416037|Device|level of positive end expiratory pressure (Prone Proseva)|PEEP based on PEEP/FIO2 table vs PEEP based on the value of oesophageal pressure
16065410|NCT02416037|Device|level of positive end expiratory pressure (Prone Talmor)|PEEP based on PEEP/FIO2 table vs PEEP based on the value of oesophageal pressure
16065411|NCT02416024|Device|SphygmoCor system|Carotid-femoral pulse wave velocity (cfPWV) will be determined by applanation tonometry using the Sphygmocor system by sequentially recording ECG-gated carotid and femoral artery waveforms. Pulse wave signals will be recorded by tonometers positioned at the base of the right common carotid artery and over the right femoral artery. The time (t) between the feet of simultaneously recorded waves will be determined as the mean of 10 consecutive cardiac cycles. PWV is calculated by the system software from the distance between measurement points (D) and the measured time delay (t) as follows: cfPWV = D/Δt (m/s) where D is distance in meters and t is the time interval in seconds.
16065412|NCT02416011|Behavioral|GENERIC|The initial Stop Smoking for Good brochure, 10 Stop Smoking for Good booklets and 9 supportive My Story pamphlets delivered over 18 months, as used in our previous cessation study.
16065413|NCT02416011|Behavioral|eTARGET|The product of Study I is expected to include the initial If You Vape brochure, a series of 10 If You Vape: Guide to Quitting Smoking booklets, distributed over 18 months, and 9 supportive My Story pamphlets, delivered in the months between booklets.
16065414|NCT02415998|Procedure|TEE|Epidural catheter will be placed under guidance of transesophageal echography in specific thoracic spinal segment.
16065415|NCT02415985|Drug|Lopinavir/r will be supplied by NHSO/GPO|200/50 mg tablet LPV/rtv
16065416|NCT02415985|Drug|Rifabutin|
16065417|NCT02415972|Other|Ultrasound perfusion imaging|Dynamic perfusion imaging of brain parenchyma with modern ultrasound is possible with the use of ultrasound contrast media that serve as echo signal amplifier.
16065418|NCT02415959|Drug|Creon IR|
16065419|NCT02415959|Drug|Creon® (DR/GR)|
16065420|NCT02415946|Procedure|Sinus floor augmentation (lateral)|
16065421|NCT02415946|Procedure|Sinus floor augmentation (transcrestal)|
16065422|NCT02415933|Behavioral|Trickle Up|"Female caregivers (mothers) receive a package of interventions on economic empowerment and livelihood strengthening:
~Savings group formation and training for a group of 15-25 women which provides a place to save, take out emergency loans and builds community networks and social capital;
~Provision of seed grants to assist in business start-ups through microfinance loans;
~One-on-one mentoring and coaching on livelihood development, which is held on a bi-weekly or monthly basis;
~Trainings on financial planning and household livelihoods."
16065423|NCT02415933|Behavioral|Trickle Up Plus|"In addition to the economic empowerment program for women (Trickle Up), all members of the household assigned to Trickle Up+ arm receive sensitization component on beliefs and knowledge related to protection of children from violence and exploitation. Training sessions are developed and delivered by a local organization, Aide aux Enfants et aux Familles Démunies (ADEFAD).
~Sessions involve all members of the household and focus on knowledge and cultural norms associated with child protective outcomes (e.g. the dangers of child separation such as sending children away for work, the importance of education for girls, risks of child and forced marriage)."
16065424|NCT02415920|Drug|Oxytocin|Participants will be randomly assigned to intra-nasally administer either oxytocin or a placebo on their first visit and then they will receive the other spray during their second visit.
16065425|NCT02415920|Drug|Placebo|Participants will be randomly assigned to intra-nasally administer either oxytocin or a placebo on their first visit and then they will receive the other spray during their second visit.
16065426|NCT02415907|Drug|[ethyl-1-14C]-idalopirdine|120 mg/2.40 MBq Lu AF67708 ([ethyl-1-14C]-idalopirdine) in one capsule for oral administration, single dose
16065427|NCT02415907|Drug|[benzyl-7-14C]-idalopirdine|120 mg/2.40 MBq Lu AF67709 ([benzyl-7-14C]-idalopirdine) in one capsule for oral administration, single dose
16065429|NCT02415881|Device|da Vinci Firefly|Da Vinci surgical robot with build-in fluorescence imaging option (Firefly technology)
16065430|NCT02415881|Device|IMAGE1 + ICG Hopkins telescope and/or VITOM|IMAGE1 + ICG Hopkins telescope and/or VITOM -- Fluorescence camera allowing for imaging of IRDye800. Camera is suitable for open and laparoscopic surgery.
16065431|NCT02415855|Drug|Dabigatran|
16065432|NCT02415842|Other|Serum samples|The archived sera samples collected in previously completed pandemic influenza vaccine clinical trials (H1N1, H5N1, and H9N2 pandemic vaccines in adult trials and H5N1 pandemic vaccine in a pediatric trial) will be tested in this study.
16065433|NCT02415829|Drug|capecitabine plus oxaliplatin|The neoadjuvant chemotherapy consisted of oxaliplatin, 130 mg/m² on day 1, with capecitabine, 1000 mg/m² twice daily for 14 days every 3 weeks (the XELOX regimen)
16065434|NCT02415816|Procedure|Diffusion Weighted Magnetic Resonance Imaging|Diffusion weighted magnetic resonance imaging (DWI MRI) is a method that does not involve radiation and can be used to assess the primary tumor as well as to image the entire patient, from head to toe. Diffusion weighted MRI uses a strong motion probing gradient to detect the movement of water in tissue. Tissues that are composed of tightly packed cells, such as tumors, allow less water movement than tissues with loosely packed cells. As tumors respond to therapy they become necrotic and cells are less tightly packed. This change in water diffusivity can be quantitated using DWI. Therefore, DWI provides a non-invasive, non-ionizing, and quantitative method of assessing tumor response at a cellular level and does not depend on a change in tumor size
16065435|NCT02415803|Drug|low-dose ticagrelor|90 mg loading dose, then 45 mg twice daily for 5 days
16065436|NCT02415803|Drug|conventional-dose ticagrelor|180 mg loading dose, then 90 mg twice daily for 5 days
16065437|NCT02415803|Drug|Clopidogrel|300 mg loading dose, then 75 mg once daily for 5 days
16065438|NCT02415790|Drug|E2027|Part A: E2027 capsules will be administered orally in doses of 10 mg to 1200 mg in Part A and in Part B, C, and D at doses not exceeding the highest dose achieved in Part A.
16065439|NCT02415790|Drug|E2027 matching placebo|E2027 matching placebo capsule will be administered.
16065440|NCT02415777|Drug|Ursodeoxycholic acid, thiamine, riboflavin|
16065441|NCT02415764|Behavioral|Behavioral/Attitudinal OnTrack Role-Playing Game|"The intervention will involve each participant sitting down at a computer for approximately one hour (over the course of one week) to complete the prototype game. Users will take on the role of a person who has experienced first-episode psychosis and moves through animated role-playing scenarios, learn practical tips for engaging in care, play mini-games to develop self-advocacy skills, and view stories of hope and recovery (brief video vignettes).
~While the intervention does not require direct supervision by the research team, technical support will be available for the duration of the study via telephone, instant messaging and email. All participants receive identical baseline surveys and 2-week follow up surveys."
16065442|NCT02415751|Behavioral|heart failure self-care education|It is defined as a naturalistic decision-making process that patients use in the choice of behaviors that maintain physiological stability (symptom monitoring and treatment adherence) and the response to symptoms when they occur (Riegel 2004). This includes following advice regarding medications, sodium and water consumption, alcohol restriction, exercise, preventive behaviors, and monitoring of signs and symptoms.
16065443|NCT02415738|Procedure|Prone positioning|
16065444|NCT02415725|Drug|Indocyanine Green|visualization of the architecture of superficial lymphatic network after Indocyanine Green injection
16065445|NCT02415712|Drug|Fomepizole|The first dose of fomepizole is administered at a dose of 15 mg/kg, followed by the second to fifth doses administered at a dose of 10 mg/kg. The sixth and subsequent doses are administered at a dose of 15 mg/kg. The interval of the intravenous doses is 12 hours with one administration lasting more than 30 minutes.
16065446|NCT02415699|Drug|Fluorouracil|
16065447|NCT02415699|Drug|Oxaliplatin|
16065448|NCT02415699|Drug|Leucovorin|
16065449|NCT02415699|Biological|DC-CIK|
16065450|NCT02415673|Device|Fixed orthodontics appliance and arch wire|Two nickel-titanium alignment and leveling sequences were employed
16065451|NCT02415660|Procedure|Thoracic spinal manipulation|All patients will receive 3 different thrust joint manipulations to the middle and upper thoracic spine region. Each technique will be applied up to 2 times, per the discretion of the treating therapist discretion
16065452|NCT02415660|Procedure|Trigger point dry needling|The TDN treatment will consist of a trained investigator inserting a needle through the participant's skin, into the deep cervical extensor muscles and/or the upper trapezius muscles using FDA approved (FDA regulation # 880.5580) disposable 0.2-0.3 x 40-50 mm stainless steel Seirin J-type needles (Seirin, Japan). Those subjects randomized to TDN will undergo this treatment.
16065453|NCT02415660|Behavioral|Cervical range of motion exercises|The patient will be instructed to place 5 fingers along the manubrium, and to flex the neck down until the chin touches the fingers. The patient will then be instructed to rotate the head as far as comfortably possible to one side, and then to the other side for 10 repetitions to each side, 3-4 times per day. The patient will progress from 5 fingers, to 4, 3, 2 and eventually 1 finger as neck mobility improves.
16065454|NCT02415660|Behavioral|Posterior neck muscle activation exercise|The patient will be instructed to sit upright in a chair, and place 1-2 fingers over the C2 spinous process. Education to localize this landmark will be provided. The patient will then perform an isometric chin tuck exercise against the resistance they will apply at C2. This position will be held x 5 seconds and repeated 10 times, 3-4 times per day.
16065455|NCT02415660|Procedure|Trigger point dry needling sham|The sham group will receive a simulated TDN. Using a toothpick in a needle guide-tube, the investigator will tap, rest, and twist the toothpick for approximately 30 seconds in the same 2 muscles, 2 sites in each muscle. The sham treatment will not penetrate the skin.
16065456|NCT02415660|Device|Seirin J-type stainless steel needles, 0-2-0.3 x 40-50 mm|A trained investigator will insert the needle through the participants skin into the deep cervical extensors and/or the upper trapezius muscles. Needles are FDA approved (#880.5580)
16065486|NCT02415452|Procedure|drug-eluting stent implantation|The DES contains Firebird , sirolimus-eluting stents, paclitaxel-eluting stents , or zotarolimus-eluting stents . Unfractionated heparin was used during percutaneous coronary intervention .A loading dose of 300 mg clopidogrel was given to all patients prior to PCI, followed by a maintenance dose of 75 mg daily for 12 months before it was stopped.
16065487|NCT02415439|Drug|VBP15|
16065488|NCT02415439|Drug|Placebo|
16065457|NCT02415634|Other|RECAP|"Patients will receive an information pack at ICU discharge called the RECAP. This pack will include
~Part 1: A critical care discharge summary (UCCDIP) (Bench and Day, 2012)
~Part 2: A rehabilitation goal setting care plan
~Part 3: A patient communication forum
~Part 4: Useful supports and contact information
~Part 5: Tailored exercise programme
~The patient will have a consultation with the ICU physiotherapist before ICU discharge once weekly thereafter for 3 weeks . The focus of the session will be to discuss goal attainment and associated challenges.
~The ICU therapist will meet once weekly with the patient's primary physiotherapist to provide clinical support if necessary, in determining the patient's needs post critical care."
16065458|NCT02415634|Other|Control|Participants allocated to the control group will receive standard physiotherapy intervention post ICU discharge
16065459|NCT02415621|Drug|Abiraterone Acetate|1000 mg by mouth (PO) every day (QD)
16065460|NCT02415608|Drug|Ibrutinib|Given orally in 28-day cycles
16065461|NCT02415595|Drug|BMS-955176|HIV Maturation Inhibitor
16065462|NCT02415595|Drug|EFV|EFV
16065463|NCT02415595|Drug|TDF/FTC|TDF/FTC
16065464|NCT02415582|Other|Aerobic exercise|Aerobic exercise on treadmill
16065465|NCT02415582|Other|Combined exercises|Combined resistance and aerobic exercise
16065466|NCT02415582|Other|Control|45 minutes resting sitting
16065467|NCT02415569|Drug|Standard Bowel Prep (2L PEG-ELP)|Subjects whose bristol stool forms are type 1 or 2, will be asked to take standard bowel prep (2L PEG-ELP) the same-day of procedure.
16065468|NCT02415569|Drug|2L PEG-ELP and 10mg bisacodyl|Subjects whose bristol stool forms are type 1 or 2, will be asked to take standard bowel prep (2L PEG-ELP) the same-day of procedure and 10mg bisacodyl the day before procedure.
16065469|NCT02415569|Drug|Standard Bowel Prep (2L PEG-ELP)|Subjects whose bristol stool forms are type 3 to 7, will be asked to take standard bowel prep (2L PEG-ELP) the same-day of procedure.
16065470|NCT02415556|Drug|Regular Human Insulin|Regular human insulin 40 IU daily over 24 weeks
16065471|NCT02415556|Drug|Placebo|Intranasal sterile saline 40 IU daily over 24 weeks
16065472|NCT02415543|Procedure|SIL-TEP Inguinal Hernia Repair|perform the laparoscopic total extraperitoneal inguinal hernia repair using a single incision
16065473|NCT02415543|Procedure|TEP Inguinal Hernia Repair|perform the multiport laparoscopic total extraperitoneal inguinal hernia repair
16065474|NCT02415530|Behavioral|Combined home visiting and group intervention|home visit includes pre-discharge meeting with parents; education of appropriate feeding, breastfeeding, sleeping, position of baby, defecation, environment for baby care and resuscitation on emergency situation first visit (5 days after discharge); understanding baby's sign check feeding, sleeping, sanitation, defecation, environment second visit (14 days after discharge); understanding baby's sign and baby's development support parents check feeding, sleeping, sanitation, defecation, environment special situation third visit (4 weeks after discharge) understanding baby's sign and baby's development support parents special situation fourth visit (8 weeks after discharge) same as third visit Group intervention for parental support with baby 12 times during corrected age 3~6 months
16065475|NCT02415530|Other|No intervention|No intervention
16065476|NCT02415517|Behavioral|Cognitive training|"Cognitive training on computer. Six sessions with different tasks: Tiere merken & Räumlich visuelles Training (application BrainTwister) and Taskswitching (programmed with eprime)"
16065477|NCT02415517|Behavioral|Test of general knowledge|Training of general knowledge on computer. Six sessions with different topics.
16065478|NCT02415504|Behavioral|Enhanced care transition|Enhanced care transition discharge package: (1) an integrated behavioural care plan, (2) an in-person discharge meeting including family, post-care transition staff (LTC or another hospital unit) and unit staff, (3) videos of responsive behaviours and non-pharmacological interventions, (4) a briefcase of favoured activities, (5) an in-person care demonstration, and (6) involvement of a transitional care team.
16065479|NCT02415504|Behavioral|Standard care transition|Standard care transition discharge package: The standard care transition varies by unit, and either consists of: (1) a discipline specific care plan, (2) a phone discharge meeting between unit staff and post-care transition staff (LTC or another hospital unit) and (3) a follow-up phone call with social work OR (1) a discipline specific care plan, (2) an in-person meeting between unit staff and (family) caregivers, (3) involvement of a transitional care team, and (4) a follow-up phone call with social work.
16065480|NCT02415491|Other|Correlation Heart Magnetic Resonance Imaging at rest and stress with Cardiopulmonary stress test|"MRI of the heart, coronary arteries and pulmonary artery at rest and stress induced will be performed. Cine pictures are taken for evaluation of pulmonary perfusion.
~Afterwards induced stress MRI will be performed according to standard protocol with elevation of dobutamine levels until the reach of peak HR. If applicable the procedure will be stopped) in case of e.g. arrhythmia.
~Cardiopulmonary exercise stress test will be performed; patient will sit at rest on the ergometer, the subject's gas exchange will be recorded; with the pedal speed constant, the resistance will be increased from 0.5 watt/kg to 3 watt/kg over 10 minutes. Electrocardiography and heart rate will be taken continuously during and until 10 minutes afterwards. Blood pressure will be taken before, during and after the stress test. Respiratory gas exchange parameters will be taken continuously, peak oxygen uptake (VO2) determined as well as Ventilatory Efficiency."
16065481|NCT02415478|Other|endoscopic lung volume reduction by valves|"Independent of the study, subject will get a bronchoscopy with chartis measurement in general anaesthesia. chartis measurement is a Balloon angioplasty. Balloon will be well-positioned in lung and filled by air for occlusion of lobe of the lung. System recognizes collateral ventilation of lobe of the lung via calculation of airflow resistance.
~Negative result allows the endoscopic placement of selfexpandig endobronchial valves in the subject lung. Inhale airflow will be inhibit an enclosed air and liquids can exhaust."
16065482|NCT02415465|Procedure|Continuous Adductor Canal Block|Continuous Adductor Canal Block (0.2% ropivacaine running at 6-8mL/hr)
16065483|NCT02415465|Procedure|General|General Intraoperative Anesthesia
16065484|NCT02415465|Procedure|Epidural|Epidural (0.1% bupivacaine with fentanyl 5 mcg/mL running at 6mL/hr with 1mL q15 bolus)
16065485|NCT02415465|Procedure|Spinal|Spinal Intraoperative Anesthesia
16065534|NCT02415088|Procedure|Interscalene block|block of the plexus brachialis in the interscalene region with local anaesthetics
16065535|NCT02415088|Procedure|Selective shoulder block|selective block of the suprascapular nerve and the axillary nerve with local anaesthetics
16065489|NCT02415426|Behavioral|Metacognitive Training Program during mild to moderate depression|Diagnostic and therapeutical interventions are not part of this study. As part of this study, the change of cognitive and psychosocial achievement/behavior in patients with mild to moderate depression after taking part in the training program is being investigated. The training program seeks to enable group members to recognize and correct the often automatic and unconscious thought patterns that accompany depression, in part by viewing this depressive thought process at a distance (i.e., depersonalizing). In addition, dysfunctional assumptions about one's thought processes, as well as dysfunctional coping-strategies (i.e., thought suppression, rumination as problem-solving) are targeted (Lena Jelinek & Steffen Moritz, http://clinical-neuropsychology.de/metacognitive_training_for_depression.html).
16065490|NCT02415413|Drug|carfilzomib|
16065491|NCT02415413|Drug|Lenalidomide|
16065492|NCT02415413|Drug|Dexamethasone|
16065493|NCT02415413|Drug|Melphalan|
16065494|NCT02415400|Drug|Apixaban|
16065495|NCT02415400|Drug|vitamin K antagonist|
16065496|NCT02415400|Drug|Acetylsalicylic acid|
16065497|NCT02415400|Other|Acetylsalicylic acid placebo|
16065498|NCT02415387|Biological|typhoid vaccine|Given IM
16065499|NCT02415387|Other|Placebo|Given IM
16065500|NCT02415374|Other|Avenanthramides|AVAs are a group of diphenolic acids that are found only in oats (Avena sativa). In this study, each dietary group of subjects will receive three cookies made with oat flour containing high-AVA (H-AVA, 229.56 mg/kg) and low-AVA (L-AVA, 32.69 mg/kg).
16065501|NCT02415361|Other|Cleft lip and palate|Comparison between Arm A who will receive standard care and Arm B who will receive systematic follow up performed by a special trained nurse will be performed.
16065502|NCT02415348|Device|Fibroscan|
16065503|NCT02415335|Drug|dexamethasone phosphate|Intravenously administration minimum of 30 minutes preoperatively.
16065504|NCT02415335|Drug|Isotonic NaCl|Intravenously administration minimum of 30 minutes preoperatively
16065505|NCT02415322|Other|refer to mental health specialists|children who have diagnosed internet and/or smartphone disorder by psychiatrists referred to mental health specialists
16065506|NCT02415309|Drug|2 mg Melatonin|40 patients will randomly receive 2 mg melatonin
16065507|NCT02415309|Drug|10mg Melatonin|40 patients will randomly receive 10 mg melatonin
16065508|NCT02415309|Other|Placebo|40 patients will randomly receive a placebo/sugar pill
16065509|NCT02415296|Other|stage 1|The first stage of the project aims at providing a general description of the behaviour of French online gamblers, especially defining a typology of online gamblers.
16065510|NCT02415296|Other|stage 2|The second stage of the project aims at checking that the criteria selected in the first stage lead to a correct prediction whether the gambler is problematic or not. Particularly, this stage aims at determining the best possible score (calculated from gambling data) for defining the gambler's status.
16065511|NCT02415296|Other|stage 3|The third stage of the project aims at clinically validating the screening model. Result from the screening model will be compared to the diagnostic obtained with a clinical interview.
16065512|NCT02415283|Device|¹³C-Octanoate Breath Test|Breath testing utilizing 13C is a safe, non-invasive means for measuring a certain pathway's metabolic rate. 13C is a stable, non-radioactive isotope which can be incorporated into a specific location within a test substrate so it would be released when the compound is metabolized by the liver. Hepatic metabolism of the compound is assessed by measuring the ratio of 13CO2/12CO2 in exhaled breath.
16065513|NCT02415270|Other|Reduced Nicotine Cigarettes|Human topography data will show if smokers smoke their cigarettes differently from baseline following randomization. Select biosamples of participants will be used to analyze how biomarkers differ among groups
16065514|NCT02415270|Other|Reduced ROS/RNS|Human topography data will show if smokers smoke their cigarettes differently from baseline following randomization. Select biosamples of participants will be used to analyze how biomarkers differ among groups
16065515|NCT02415270|Other|Control|Human topography data will show if smokers change the way they smoke due to being in a research study. Select biosamples of participants will be used to analyze how biomarkers differ among groups
16065516|NCT02415257|Drug|Gentamicin|Intratympanic installation of gentamicin 2-4 times depending on the efficacy of vestibular deafferentation
16065517|NCT02415244|Procedure|TEE|Spinal cord segments will be imaged using the TEE
16065518|NCT02415231|Behavioral|humor|
16065519|NCT02415218|Biological|Mucosal cell sheet transplantation|The subjects will have their oral mucosal tissues retrieved for cell sheet preparation. The mucosal cell sheet will be transplanted over the affected cornea.
16065520|NCT02415192|Drug|Levacalm|
16065521|NCT02415192|Drug|Valsartan/amlodipine|
16065522|NCT02415179|Drug|Inhaled Mometasone/formoterol|Inhaled Mometasone/formoterol (100/5 microgram) 2 puffs twice daily via metered dose inhaler for 6 weeks
16065523|NCT02415179|Drug|Inhaled Fluticasone/Salmeterol|Inhaled Fluticasone/Salmeterol (125/25 microgram) 2 puffs twice daily delivered by using metered dose inhaler for 6 weeks
16065524|NCT02415166|Biological|INFLUENZA VACCINE|THE PURPOSE OF THE STUDY IS TO EVALUATE THE EFFICACY OF THE SEASONAL INFLUENZA VACCINE IN PEOPLE WITH MAJOR DEPRESSIVE DISORDER
16065525|NCT02415166|Other|NaCl-saline placebo|placebo
16065526|NCT02415153|Other|Laboratory Biomarker Analysis|Optional correlative studies
16065527|NCT02415153|Other|Pharmacological Study|Correlative studies
16065528|NCT02415153|Drug|Pomalidomide|Given PO
16065529|NCT02415140|Other|Rate of depression|
16065530|NCT02415127|Drug|Interferon γ-1b|The study drug dose is planned to be escalated on a weekly basis over the first 4 weeks of treatment (from 10 µg/m² to 25, 50, and 100 µg/m²). The dose may be reduced, interrupted, or held based on tolerability. By Week 13, all participants are to be on a stable tolerated dose of study drug in order to continue study participation; the dose may not be further increased after week 13, however, it may be reduced on a case-by-case basis to manage drug-related adverse events (AEs).
16065531|NCT02415127|Drug|Placebo|The volume of placebo is planned to correspond with volume of study drug that would be given to the participant if the participant was randomized to the study drug arm.
16065532|NCT02415114|Dietary Supplement|Omega Q Plus Resveratrol (with 50mg CoQ10)|Omega Q Plus Resveratrol (with 50mg CoQ10)
16065533|NCT02415101|Procedure|Resective surgery|
16065536|NCT02415075|Behavioral|medical rehabilitation|Participants who will take part in the study are asked to fill out a questionnaire when arriving at the rehabilitation clinic and will be invited to participate in two motivational telephone interviews after six and 12 months.
16065537|NCT02415062|Drug|Donepezil|23mg/day for 24 weeks versus 10mg/day for 24 weeks
16065538|NCT02415049|Other|Incremental Feeds|This arm of patients will be fed in the traditional standard of care manner following pyloromyotomy. They start with 15ml of pedialyte and advance by 15ml increments of formula or breastmilk to a goal of 100ml/kg/day
16065539|NCT02415049|Other|Ad lib feeds|This arm of patients will be fed ad lib following pyloromyotomy. They will be allowed to eat as frequently as they desire based on infant cues to a goal of 12.5ml/kg/feed
16065540|NCT02415036|Device|Delcath Hepatic Delivery System|
16065541|NCT02415036|Drug|Melphalan|
16065542|NCT02415023|Drug|fruquintinib+paclitaxel|28-day cycle of fruquintinib qd for 3 weeks followed by 1-week break combined with paclitaxel 80 mg/m2
16065543|NCT02415010|Device|Enterprise 2 Vascular Reconstruction Device|Stenting Assisted coiling procedure
16065544|NCT02414997|Procedure|RIPC|Surround left upper limb with cuff, inflate cuff to 200mmHg and maintain 5 minutes, than deflate to 0mmHg. Change to right upper limb and repeat the procedure described above. Change back to left upper limb and repeat the same procedure. Perform once a day ( Thus 15 minutes a day).
16065545|NCT02414997|Procedure|Sham RIPC|Surround left upper limb with cuff, inflate cuff to 20mmHg and maintain 5 minutes, than deflate to 0mmHg. Change to right upper limb and repeat the procedure described above. Change back to left upper limb and repeat the same procedure. Perform once a day ( Thus 15 minutes a day).
16065546|NCT02414984|Biological|Golimumab|This is an observational study. Participants with rheumatoid arthritis in Colombia will be observed for 24 months.
16065547|NCT02414971|Other|There is no intervention|There is no intervention
16065548|NCT02414958|Drug|Empagliflozin|
16065549|NCT02414958|Drug|Empagliflozin|
16065550|NCT02414958|Drug|Placebo|
16065551|NCT02414945|Drug|Cyclophosphamide|
16065552|NCT02414945|Drug|Fludarabine|
16065553|NCT02414945|Biological|Autologous tumor infiltrating lymphocytes (TILs)|
16065554|NCT02414945|Biological|Interleukin-2|
16065555|NCT02414932|Drug|Ketamine|Ketamine hydrochloride 0.5 mg/kg; Pfizer Healthcare Ireland
16065556|NCT02414932|Drug|Midazolam|Midazolam 0.045 mg/kg; Roche Products Ireland Ltd
16065557|NCT02414919|Drug|Mirena (Levonorgestrel IUS, BAY86-5028)|Levonorgestrel-releasing intrauterine device 20 mcg/day
16065558|NCT02414919|Drug|ParaGard|Copper T380A
16065559|NCT02414919|Drug|Implanon/Nexplanon|Etonorgestrel contraceptive implant
16065560|NCT02414906|Other|Goal-directed therapy|Goal-directed therapy with fluids and dobutamine
16065561|NCT02414893|Procedure|Sleeve gastrectomy|Laparoscopic vertical gastrectomy as a bariatric procedure.
16065562|NCT02414880|Drug|Sugammadex|Rocuronium-induced neuromuscular blockade will be reversed at the end of the operation when two responses to train-of-four ulnar nerve stimulation are detected (T2) by injection of sugammadex 2mg/kg.
16065563|NCT02414880|Drug|Neostigmine|Rocuronium-induced neuromuscular blockade will be reversed at the end of the operation when two responses to train-of-four ulnar nerve stimulation are detected (T2) by injection of neostigmine 50 micro-gram/kg combined with atropine 20 micro-gram/kg.
16065564|NCT02414880|Drug|Rocuronium|An intubating dose of Rocuronium (0.6 mg/kg) will be given with induction of anesthesia and the degree of muscle relaxation will be evaluated through out the operation by recording the response of the hand muscles to train-of-four ulnar nerve stimulator (Mechanosensor Neuromuscular Transmission Module of General Electric AISYS Anaesthesia machine USA) according to the Good Clinical Research Practice (GCRP) guidelines for pharmacodynamic neuromuscular studies. Muscle relaxation will be maintained by additional top-up doses of Rocuronium (0.15mg/kg) which will be administered after detection of the first response to TOF stimulation (T1).
16065565|NCT02414854|Drug|Dupilumab|Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.
16065566|NCT02414854|Drug|Placebo|Solution for injection, Subcutaneous injection in the abdomen, upper thigh or upper arm.
16065567|NCT02414854|Drug|Inhaled corticosteroid (ICS) therapy|Oral inhalation, stable dose (medium or high dose) of ICS in combination with up to 2 other controller medicines (second or third controller therapy)
16065568|NCT02414854|Drug|Albuterol/Salbutamol|Oral inhalation as needed
16065569|NCT02414854|Drug|Levalbuterol/Levosalbutamol|Oral inhalation as needed
16065570|NCT02414841|Drug|Vonapanitase|
16065571|NCT02414841|Drug|Placebo|
16065572|NCT02414828|Biological|Placebo|This is the identical buffer solution in which AERAS-402 is formulated. The placebo (1.0 mL volume) was administered by intramuscular (IM) injection to the deltoid area on Study Day 0 for groups 1 and 2 and Study Day 0 and 42 for group 3.
16065573|NCT02414828|Biological|AERAS-402 3 x 10^8 vp|AERAS-402 was administered by single intramuscular (IM) injection to the deltoid area on Study Day 0
16065574|NCT02414828|Biological|AERAS-402 3 x 10^9 vp|AERAS-402 was administered by single intramuscular (IM) injection to the deltoid area on Study Day 0
16065575|NCT02414828|Biological|AERAS-402 3 x 10^10 vp|AERAS-402 was administered by intramuscular (IM) injection to the deltoid area on Study Days 0 and 42.
16065576|NCT02414815|Device|Monophasic action potential(MAP) catheter|After ordinary procedure for electrophysiologic study or catheter ablation, the investigators will replace conventional catheter to monophasic action potential (MAP) recording catheter through right femoral sheath. MAP recording catheter is introduced to endocardial surface of atrium, and we record atrial MAP at variable pacing cycle lengths: steady state cycle lengths of 600, 400, 300, 240, 220, 240, 260, 300, 400 and 600 ms. At each cycle length, pacing was applied for 20 sec. It takes less than 5 min to acquire MAP recordings.
16065577|NCT02414802|Device|a manual spiral thrombus broken suction device|A manual spiral thrombus broken suction device will be used for thrombectomy before catheter-directed thrombolysis
16065578|NCT02414802|Procedure|catheter-directed thrombolysis|catheter-directed thrombolysis will be used in both arms
16065579|NCT02414802|Drug|low-molecular-weight heparin calcium|anticoagulation therapy will be administered via subcutaneous injection of low-molecular-weight heparin calcium (LMWH-Ca 5,000 U/12 h) in both arms at discharge
16066065|NCT02411448|Drug|Osimertinib|Administered orally.
16065580|NCT02414802|Drug|urokinase|A total of 100,000 units urokinase once every 4-6 hours will be used during catheter-directed thrombolysis therapy
16065581|NCT02414789|Procedure|Skin biopsies|Skin biopsies of patients with Lyme disease (erythema migrans) infected with Borrelia burgdorferi sensu lato will be analyzed by three diagnostic techniques : molecular technique (PCR), biological technique (culture of the bacteria) and proteomics technique (SRM/ MS-MS)
16065582|NCT02414776|Drug|hydroxychloroquine|administration of hydroxychloroquine in combination with the current hormonal therapy
16065583|NCT02414763|Behavioral|Teachable Moment Brief Intervention|functional analysis, collaborative interpersonal style
16065584|NCT02414750|Drug|Vemurafenib plus cobimetinib|Molecular targeted therapy for BRAF mutated advanced melanoma patients
16065585|NCT02414750|Device|Positron Emission Tomography|Patient will need to undergo FDG and FLT PET scanning before and during treatment, and at time of progression
16065586|NCT02414750|Procedure|Tissue sampling|Before and during treatment and at time of progression patients will undergo tissue sampling of a melanoma lesion
16065587|NCT02414750|Procedure|Blood sampling|Before and during treatment and at time of progression patients will undergo blood sampling
16065588|NCT02414737|Drug|corifollitrophin alfa|use of a single dose of corifollitrophin alfa to provide adequate controlled ovarian hyperstimulation during IVF treatment
16065589|NCT02414724|Drug|Gemcitabine Hydrochloride|Given IV
16065590|NCT02414724|Other|Laboratory Biomarker Analysis|Correlative studies
16065591|NCT02414724|Other|Pharmacological Study|Correlative studies
16065592|NCT02414724|Drug|Ribociclib|Given PO
16065593|NCT02414711|Other|HSCL25 scale|The patient must answer to 25 questions of the HSCL25 scale. In function of the results, the patients was diagnosed depressed (≥1.75) or not depressed (<1.75)
16065594|NCT02414711|Other|PSE9 questionary|On the 900 patients recruited, 50 patients who was diagnosed depressed or no depressed have to have a psychological interview with the PSE9 questionary to validate the first diagnosis done by the HSCL25 scale
16065595|NCT02414698|Procedure|Percutaneous Hydrodiscectomy|The HydroD uses a thin supersonic stream of water to cut, ablation, remove disc material percutaneously via a skin puncture.
16065596|NCT02414698|Drug|TESI|Transforaminal epidural steroid injections given in the lumbar spine.
16065597|NCT02414685|Drug|Paclitaxel|paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements
16065598|NCT02414685|Drug|Ifosfamide|paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements
16065599|NCT02414685|Drug|Cisplatin|paclitaxel, ifosfamide, cisplatin until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements
16065600|NCT02414672|Behavioral|CareSTEPS|Caregivers receive a workbook and 6 one-hour telephone sessions with a trained interventionist.
16065601|NCT02414659|Procedure|Umbilical cord blood collection, in-utero|Umbilical cord blood was collected during cesarean, after delivery of the baby and after clamping of the cord. Blood was collected into a standard blood donation bag with (Capacity: 450 mL) a 16 G venipuncture needle. Needle was left in place after umbilical vein is collapsed and no more blood flow happens spontaneously.
16065602|NCT02414620|Device|Generation II Dental Vibe Unit|. The Dental Vibe emits strong pulsed vibration which is transmitted via a silicone mouth piece to mucosal tissue.
16065603|NCT02414607|Biological|Elderberry Juice|
16065604|NCT02414607|Other|Placebo|
16065605|NCT02414594|Drug|IONIS-APO(a)-LRx|Ascending single and multiple doses of IONIS-APO(a)-LRx by subcutaneous (SC) injection
16065606|NCT02414594|Drug|Sterile Normal Saline (0.9% NaCl)|Calculated volume to match active comparator
16065607|NCT02414581|Drug|chlorhexidine 0.12%/Ethyl alcohol 7%|Mouth rinses with chlorhexidine 0.12%-based solution
16065608|NCT02414581|Drug|Ethyl Alcohol 7%|Mouth rinses with Ethyl Alcohol 7%-based solution
16065609|NCT02414581|Drug|Chlorhexidine 2%/Ethyl alcohol 7%|Mouth rinses with chlorhexidine 2%-based solution
16065610|NCT02414568|Drug|Bendamustine|Bendamustine 120 mg/m2 (IV) Day 1
16065611|NCT02414568|Drug|Prednisone|Prednisone 40 mg/m² PO
16065612|NCT02414568|Drug|Vinblastine|Vinblastine 6 mg/m² IV
16065613|NCT02414568|Drug|Doxorubicin|Doxorubicin 40 mg/m² IV
16065614|NCT02414555|Drug|vasopressor|Patients receive oesophageal doppler-based hemodynamic support either with fluid or with vasopressor
16065615|NCT02414555|Drug|fluid bolus|
16065616|NCT02414555|Device|oesophagus doppler (CardioQ)|
16065617|NCT02414555|Drug|Normal Saline|
16065618|NCT02414555|Device|arterial cannulation|
16065619|NCT02414555|Device|intravenous peripheral line insertion (17 gauge)|for fluid bolus administration
16065620|NCT02414555|Drug|Elo-Mel Isoton (balanced acetat-based infusate)|
16065621|NCT02414542|Device|MINIMA stem|
16065622|NCT02414529|Drug|Vitamin D2|Ergocalciferol 5000 units capsules given. 300,000 units PO once.
16065623|NCT02414529|Drug|Placebo|
16065624|NCT02414516|Drug|OBP-801|OBP-801 will be administered IV
16065625|NCT02414503|Drug|8IU intranasal oxytocin|
16065626|NCT02414503|Drug|24IU intranasal oxytocin|
16065627|NCT02414503|Drug|Placebo|
16065628|NCT02414503|Device|OptiNose Breath Powered Bi|
16065629|NCT02414490|Drug|Intravenous Immunoglobulin|The decision to treat with IVIg will be entirely at the discretion of the patient's treating physician.
16065630|NCT02414477|Drug|Deuterated NNN|Smokeless tobacco study product
16065631|NCT02414464|Other|35% hydrogen peroxide|"Prophylaxis was performed with a jet of sodium bicarbonate to remove extrinsic pigments and plaque.
~Each patient underwent two bleaching sessions. A lip retractor (Arc Flex, FGM®) was placed. Cotton roles or gauze compresses were used to achieve relative isolation. A dental dam (Top Dam, FGM®) was placed over the free marginal gingival tissue and the inter-tooth papillae of teeth 14 to 24 in each session. The Whiteness HP 35% gel was applied to the vestibular faces of these teeth.
~In the present study, the Whiteness HP 35% gel was applied without an external auxiliary source. As this is not a self-catalyzed system, the gel was removed after each 15-minute application and reapplied two more times, totaling 45 minutes of contact with the teeth."
16065791|NCT02413281|Drug|ALKS 5461|Sublingual tablets, single administration
16065632|NCT02414464|Other|35% hydrogen peroxide|"Prophylaxis was performed with a jet of sodium bicarbonate to remove extrinsic pigments and plaque.
~Each patient underwent two bleaching sessions. A lip retractor (Arc Flex, FGM®) was placed. Cotton roles or gauze compresses were used to achieve relative isolation. A dental dam (Top Dam, FGM®) was placed over the free marginal gingival tissue and the inter-tooth papillae of teeth 14 to 24 in each session. The Whiteness HP Blue Calcium 35% gel was applied to the vestibular faces of these teeth for 40 minutes in each session."
16065633|NCT02414464|Other|20% hydrogen peroxide|"Prophylaxis was performed with a jet of sodium bicarbonate to remove extrinsic pigments and plaque.
~Each patient underwent two bleaching sessions. A lip retractor (Arc Flex, FGM®) was placed. Cotton roles or gauze compresses were used to achieve relative isolation. A dental dam (Top Dam, FGM®) was placed over the free marginal gingival tissue and the inter-tooth papillae of teeth 14 to 24 in each session. The Whiteness HP Blue Calcium 20% gel was applied to the vestibular faces of these teeth 50 minutes in each session."
16065634|NCT02414451|Drug|Propranolol|Week 1: 40 mg propranolol (1 capsule, nightly) Week 2: 80 mg propranolol (2 40mg capsules, morning & night) Weeks 3 - 8: 100 mg propranolol (3 capsules, 40 mg/morning, 20mg/afternoon, & 40mg/night) Week 9: 60 mg propranolol (2 capsules, 40 mg/morning & 20mg/night) Week 10: 20 mg propranolol (1 capsule, nightly) Week 11: no capsules
16065635|NCT02414451|Drug|Placebo|"Placebo will be administered via lactose-filled oral capsule(s) daily for a period of 10 weeks. The schedule of placebo administration will be as follows:
~Week 1: 1 capsule, nightly Week 2: 2 capsules, morning & night Weeks 3 - 8: 3 capsules, morning, afternoon, & night Week 9: 2 capsules, morning & night Week 10: 1 capsule, nightly Week 11: no capsules"
16065636|NCT02414438|Other|FirstStepDX PLUS and NextStepDX PLUS Webinar|A pre-recorded 20-minute webinar on FirstStepDX PLUS and NextStepDX PLUS
16065637|NCT02414438|Other|FirstStepDX PLUS and NextStepDX PLUS Test Results|Physicians receive a prompt to order and download FirstStepDX PLUS and NextStepDX PLUS Test Results
16065638|NCT02414425|Procedure|Rectoscopy|A rectoscopy will be performed for Botulinum toxin A or physiologic serum injection
16065639|NCT02414425|Procedure|Anorectal manometry|Anorectal manometry will be performed to evaluate efficacy of Botulinum toxin A or physiologic serum rectal injection
16065640|NCT02414425|Drug|Botulinum toxin A or physiologic serum injection|Botulinum toxin A or physiologic serum injection is performed during rectoscopy
16065641|NCT02414412|Dietary Supplement|Ulmus macrocarpa water extract|
16065642|NCT02414399|Drug|Azithromycin|oral administration of Azithromycin
16065643|NCT02414399|Drug|Placebo|5 days of taste/appearance/bottle-matched inactive substance
16065644|NCT02414386|Other|biospecimen retention|biospecimen retention to measure vitamin D, parathormone, calcium, magnesium, phosphate, globulin, albumin plasma levels
16065645|NCT02414373|Drug|Ropivacaine 2mg/ml|local anesthetics, which will epidurally administered
16065646|NCT02414373|Drug|Bupivacaine|local anesthetics, which will epidurally administered
16065647|NCT02414373|Device|6 French transurethral dual channel catheter (Gaeltec, Dunvegan, Scotland)|
16065648|NCT02414373|Device|14 French rectal balloon catheter (Gaeltec, Dunvegan, Scotland)|
16065649|NCT02414360|Other|Shortened Format|Shortened format of a systematic review
16065650|NCT02414360|Other|Full Length|Full length systematic review
16065651|NCT02414347|Drug|F 18 T807|Participants will receive a single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807. For those who cannot tolerate the full exam, participants will receive single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807.
16065652|NCT02414334|Radiation|Stereotactic Ablative Radiotherapy (SABR)|
16065653|NCT02414308|Drug|Adipose tissue stem cell injection|Stem cell will be harvested through adipose tissue by liposuction and isolation occurred Injection will distribute through corpora cavernosa and dorsal penile artery
16065654|NCT02414295|Drug|Mesenchymal stem cell injection|Aspirated bone marrow then separation for Mesenchymal stem cell
16065655|NCT02414282|Drug|F 18 T807|Participants will receive a single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807. For those who cannot tolerate the full exam, participants will receive single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807.
16065656|NCT02414269|Genetic|iCasp9M28z T cell infusions|Administration through the pleural catheter- On day 0 patients will be treated with genetically modified T cells. Thirty to 60 minutes before T cell infusion, patients will be given 650 mg of acetaminophen orally and 25- 50 mg of diphenhydramine orally or intravenously, to prevent infusion-related reactions. The genetically modified T cells will be infused for at least 15 minutes and no more than 2 hours through the indwelling pleural catheter depending on the volume of the T cells. A physician will be available during the infusion. Please note, during formulation of iCasp9M28z T cells, under or over estimation of CAR modified T Cells may occur. Patient may receive an altered fractionation of the total dose or up to 35% over or under total cell dose with approval of the PI. Patients who do not have enough cells to match the current dose cohort will be treated in the cohort in which they have cells available
16065657|NCT02414269|Drug|cyclophosphamide|Patients will receive cyclophosphamide intravenously (at 1.5 g/m^2)
16065658|NCT02414269|Drug|pembrolizumab|Pembrolizumab will be given as 200 mg flat dose infusion intravenously.
16065659|NCT02414256|Other|regional anesthesia in breast surgery|In the Hospitals involved in this study are performed routinely wall blocks (PECS I-II blocks and serratus block) during breast surgery
16065660|NCT02414243|Other|New Amino Acid formula|Ordesa's Amino-Acid based Infant Formula
16065661|NCT02414243|Other|Commercially available Amino Acid Formula|Commercially available Amino Acid Formula
16065662|NCT02414230|Drug|Drug: F 18 T807|Participants will receive a single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807. For those who cannot tolerate the full exam, participants will receive single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807.
16065663|NCT02414217|Behavioral|In-Person Diabetes Numeracy Education|"Participants randomized to the in-person education group attended four group classes, each addressing a specific set of diabetes self-care skills (i.e., understanding and using blood glucose numbers, counting carbohydrates, taking medications at the right dose and time). So that each class included a stable group of 8 and 16 participants, we ran classes in cohorts of 8-16 people. A participant always attended classes with his/her cohort."
16065792|NCT02413281|Drug|Buprenorphine|Sublingual tablets, single administration
16065664|NCT02414217|Behavioral|Online Diabetes Numeracy Education|Participants randomized to the online education group attended a single session, at which he/she completed a computerized education module that addressed understanding blood sugar values and using them to examine the impact of food, exercise, and medicines on blood sugar.
16065665|NCT02414204|Drug|Sildenafil|Sildenafil, a phosphodiesterase 5 inhibitor that enhances the effects of nitric oxide (NO), has been shown in experimental and clinical studies in cardiovascular disease to improve endothelial function and decrease vascular stenosis.
16065666|NCT02414204|Other|Placebo|Placebo will be over encapsulated to identical to drug comparison
16065667|NCT02414191|Behavioral|Benchmarked Feedback|Participants receive data, during the 6 month intervention phase, regarding their monthly temperature management performance in the form of benchmarked feedback, which is the measure of their performance in comparison the standard set by the hospital.
16065668|NCT02414191|Behavioral|Ranked Feedback|Participants receive data, during the 6 month intervention phase, regarding their monthly temperature management performance in the form of ranked feedback, which is the measure of their performance in comparison to their peers.
16065669|NCT02414178|Drug|F 18 T807|Participants will receive a single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807. For those who cannot tolerate the full exam, participants will receive single intravenous bolus injection of approximately 6.5-10mCi (240-370MBq) of F 18 T807.
16065670|NCT02414165|Biological|Toca 511|Toca 511 consists of a purified retroviral replicating vector encoding a modified yeast cytosine deaminase (CD) gene. The CD gene converts the antifungal 5-flurocytosine (5FC) to the anticancer drug 5-FU in cells that have been infected by the Toca 511 vector.
16065671|NCT02414165|Drug|Toca FC|Toca FC is an extended-release formulation of flucytosine and is supplied as 500 mg tablets
16065672|NCT02414165|Drug|Lomustine|
16065673|NCT02414165|Drug|Temozolomide|
16065674|NCT02414165|Biological|Bevacizumab|
16065675|NCT02414152|Drug|anakinra|100mg of anakinra adminstered by a subcutaneous injection for a minimum of 28 days, retreatment with additional 28 day cycle based on clinical response
16065677|NCT02414126|Other|Effect of CPAP on respiratory work and cardiac function indices during wakefulness|"Comparison of three periods of 3 hours
~st period: Spontaneous breathing for 10 minutes
~nd period: CPAP for 10 minutes
~rd period: Spontaneous breathing for 10 minutes to check the return to baseline.
~After each period, the following parameters will be recorded during 5 minutes:
~oesogastric pressures
~air flow
~gas exchange
~right and left cardiac function
~Patients > 6 years old will assess their dyspnea on a visual analogue scale"
16065678|NCT02414126|Other|Effect of CPAP on respiratory work and cardiac function indices during wakefulness|"Comparison of three periods of 3 hours
~st period: Spontaneous breathing for 10 minutes
~nd period: CPAP for 10 minutes
~rd period: Spontaneous breathing for 10 minutes to check the return to baseline.
~After each period, the following parameters will be recorded during 5 minutes:
~oesogastric pressures
~air flow
~gas exchange
~right and left cardiac function
~Patients > 6 years old will assess their dyspnea on a visual analogue scale"
16065679|NCT02414126|Other|Effect of CPAP on respiratory work and cardiac function indices during wakefulness|"Comparison of three periods of 3 hours
~st period: Spontaneous breathing for 10 minutes
~nd period: CPAP for 10 minutes
~rd period: Spontaneous breathing for 10 minutes to check the return to baseline.
~After each period, the following parameters will be recorded during 5 minutes:
~oesogastric pressures
~air flow
~gas exchange
~right and left cardiac function
~Patients > 6 years old will assess their dyspnea on a visual analogue scale"
16065680|NCT02414126|Device|CPAP|
16065681|NCT02414100|Other|Laboratory Biomarker Analysis|Correlative studies
16065682|NCT02414100|Other|Cytology Specimen Collection Procedure|Correlative studies
16065683|NCT02414087|Device|ICB Medical insoles|"Study group:
~Participants in the study group will be prescribed with customized full-length insoles (ICB Medical) to keep the subtalar joint in neutral position, using self chosen comfortable shoes, for 3 months.
~Control group:
~Participants in the control group will not be prescribed with customized full-length insoles (ICB Medical) to keep the subtalar joint in neutral position, using self chosen comfortable shoes, for 3 months"
16065684|NCT02414074|Behavioral|Youth Behavioral Intervention|Teen Intervene is an early intervention program for 12-19 year olds.
16065685|NCT02414074|Behavioral|Parent Education|Everyday Parenting is a parent training curriculum.
16065686|NCT02414061|Dietary Supplement|Whey Protein (Arla Foods Ingredients Group)|20 g whey protein isolate added to breakfast meal
16065687|NCT02414061|Other|Breakfast meal|Carbohydrate breakfast served as a standard portion (1799 kJ, 93/2/9% energy from carbohydrate/fat/protein)
16065688|NCT02414048|Drug|Pimonidazole|Pimonidazole will be administered orally and will serve to demarcate the hypoxic areas in the tumour
16065689|NCT02414009|Drug|Capecitabine|Patients in Arm A will receive capecitabine at the oral dose of 1500 mg/mq/die refracted in two daily doses from day 1 to day 14 every 28 days
16065690|NCT02414009|Drug|Temozolomide|Patients in Arm A will receive temozolomide 150 mg/mq/die refracted in two daily doses starting on day 10 to 14 every 28 days.
16065691|NCT02414009|Drug|Irinotecan|Patients in Arm B will receive FOLFIRI chemotherapy starting Day 1 q2w (every cycle) starting on Day 1 of Cycle 1. FOLFIRI consists of irinotecan (starting dose of 180 mg/m2) on day one only; 5-FU (starting bolus and 22-hour infusional doses of 400 mg/m2 and 600 mg/m2, respectively), and leucovorin (racemic, starting dose of 200 mg/m2 or L-form, starting dose of 100 mg/m2) for two consecutive days.
16065692|NCT02414009|Drug|Fluorouracil|Patients in Arm B will receive FOLFIRI chemotherapy starting Day 1 q2w (every cycle) starting on Day 1 of Cycle 1. FOLFIRI consists of irinotecan (starting dose of 180 mg/m2) on day one only; 5-FU (starting bolus and 22-hour infusional doses of 400 mg/m2 and 600 mg/m2, respectively), and leucovorin (racemic, starting dose of 200 mg/m2 or L-form, starting dose of 100 mg/m2) for two consecutive days.
16065693|NCT02414009|Drug|Leucovorin|Patients in Arm B will receive FOLFIRI chemotherapy starting Day 1 q2w (every cycle) starting on Day 1 of Cycle 1. FOLFIRI consists of irinotecan (starting dose of 180 mg/m2) on day one only; 5-FU (starting bolus and 22-hour infusional doses of 400 mg/m2 and 600 mg/m2, respectively), and leucovorin (racemic, starting dose of 200 mg/m2 or L-form, starting dose of 100 mg/m2) for two consecutive days.
16065694|NCT02413996|Device|Kinetec® knee continuous passive motion (CPM )|CPM of the knee
16065695|NCT02413996|Behavioral|Functional activities|Stairs, walking
16065696|NCT02413996|Other|VRRS rehabilitation|exercise therapy through a virtual reality rehabilitation system (VRRS)
16065697|NCT02413996|Other|traditional rehabilitation|exercise therapy through a traditional rehabilitation training made by physiotherapists
16065698|NCT02413983|Procedure|hepatectomy conventional incision|This study was a single center, nonrandomized, observational comparative analysis of 3 different surgical technique. Three surgical teams operated alternately at our center, and donors undergoing hepatectomy via three different incision
16065699|NCT02413983|Procedure|hepatectomy midline incision|
16065700|NCT02413983|Procedure|hepatectomy transverse incision|
16065701|NCT02413970|Device|Inspire® UAS System|This is a single-arm study; all participants will be implanted with the Inspire® UAS System, which is a permanent, implantable therapy that consists of three implantable components: an IPG, a stimulation lead, and a sensing lead. In addition, the study subject receives a remote control to activate the therapy.
16065702|NCT02413957|Other|Medication Reconciliation|Pharmacist take the best possible medication history (BPMH), comparison of the BPMH with the admission order (AMO), clarify and solve al discrepancies between the BPMH and the AMO.
16065703|NCT02413957|Other|Pharmaceutical Care|Checking medication under safety considerations (medication at admission, during hospital stay, at discharge); recommendations for inappropriate medication (e.g. contraindications or interactions) or medication related problems. Pharmaceutical care includes Medication Reconciliation.
16065704|NCT02413944|Procedure|ACTH stimulation test|ACTH stimulation test
16065705|NCT02413931|Other|Routine management practices applied|all patients will be treated according to routine procedures, no intervention
16065706|NCT02413918|Drug|iloperidone|Qualifying subjects will take iloperidone starting at 2mg and up to a minimum of 12mg, maximum of 24mg, for 20 weeks in conjunction to the subjects current lithium, and or divalproex, and or lamotrigine.
16065707|NCT02413905|Biological|Stool samples|Stool samples
16065708|NCT02413879|Device|CleanCision|Wound protection during colorectal surgery.
16065709|NCT02413866|Behavioral|Calorie restriction only|Participants randomly assigned to this group will be instructed to reduce their daily energy intake to 95% of their resting metabolic rate.
16065710|NCT02413866|Behavioral|Sleep & calorie restriction|Participants randomly assigned to this group will be instructed to reduce their total time in bed by 90 minutes 5 days a week, in addition to restricting their dietary intake to approximately 95% of their resting metabolic rate.
16065711|NCT02413853|Drug|CBP/beta-catenin Antagonist PRI-724|Given IV
16065712|NCT02413853|Biological|Bevacizumab|Given IV
16065713|NCT02413853|Drug|Leucovorin Calcium|Given IV
16065714|NCT02413853|Drug|Oxaliplatin|Given IV
16065715|NCT02413853|Drug|Fluorouracil|Given IV
16065716|NCT02413853|Other|Laboratory Biomarker Analysis|Correlative studies
16065717|NCT02413840|Behavioral|Baduanjin qigong|
16065718|NCT02413827|Drug|Combination of varlilumab and ipilimumab|"Eligible patients will receive assigned treatments once every 3 weeks for a total of 4 treatments.
~Phase l dose: The planned dose of varlilumab will be dependent on the cohort assigned at enrollment. Varlilumab doses are 0.3 mg/kg or 3 mg/kg. Ipilimumab dose is 3 mg/kg."
16065719|NCT02413827|Drug|Cohort A: varlilumab & ipilimumab; Cohort B: varlilumab, ipilimumab, CDX-1401 & poly-ICLC|"Eligible patients will receive assigned treatments once every 3 weeks for a total of 4 treatments.
~Phase ll dose: The planned dose of varlilumab will be established from Phase I. Ipilimumab dose is 3 mg/kg. Patients assigned to receive CDX-1401 will receive a dose of 1 mg along with 2 mg poly-ICLC."
16065720|NCT02413814|Behavioral|Anger Reduction Treatment|Eight 30-minute sessions of interpretation modification to reduce angry interpretation biases.
16065721|NCT02413814|Behavioral|Control Condition|Eight 30-minute sessions of informative videos on healthy living and relaxation videos.
16065722|NCT02413788|Other|aerobic exercise|aerobic training 40 minutes on a treadmill (60-80% of maximum heart rate)
16065723|NCT02413788|Other|combined exercise|aerobic training 40 minutes on a treadmill (60-80% of maximum heart rate); resisted training in equipment and free weights for 10 minutes with a set of 10 repetitions in quadriceps, triceps and biceps of the arms and legs
16065724|NCT02413788|Device|treadmill|
16065725|NCT02413762|Other|No intervention|No intervention
16065726|NCT02413736|Drug|Imatinib|Imatinib 400 mg/day
16065727|NCT02413723|Device|Videolaryngoscope|McGrath Mac videolaryngoscope will be use for first attempt of intratracheal intubation.
16065728|NCT02413723|Device|Standard laryngoscope|Macintosh laryngoscope will be use for first attempt of intratracheal intubation.
16065729|NCT02413710|Other|Soy protein containing foods|Daily consumption of 2 food products, each providing 15g of soy protein per day.
16065730|NCT02413710|Behavioral|Dietary Guidance|Subjects will be instructed on the 2010 Dietary Guidelines for Americans including publically available information from the United States Department of Agricultural (USDA) MyPlate program (www.choosemyplate.gov). Subjects in this intervention group will not receive study provided foods.
16065731|NCT02413697|Device|Two-dimensional ultrasound|Two-dimensional ultrasound guided embryo transfer
16065732|NCT02413697|Device|Three-dimensional ultrasound|Three-dimensional ultrasound guided embryo transfer
16065733|NCT02413684|Behavioral|Patient engagement toolkit|"Pack Health LLC and Duke will develop a patient engagement toolkit known as Packs to help empower and engage patients. These disease-specific, evidence-based kits are scientifically designed to improve patient involvement in their own care"
16065734|NCT02413671|Dietary Supplement|Lupin Protein|Subjects received a standardized test meal rich in carbohydrates and supplemented with lupin protein.
16065735|NCT02413671|Dietary Supplement|Whey Protein|Subjects received a standardized test meal rich in carbohydrates and supplemented with whey protein.
16065736|NCT02413671|Other|Reference|Subjects received a standardized test meal rich in carbohydrates and not supplemented with any protein.
16065737|NCT02413658|Drug|Phenytoin|Topical use of phenytoin solution on dressings of split thickness skin graft sites.
16065738|NCT02413658|Drug|Sugar solution|
16065739|NCT02413645|Biological|TriMix_100|100 μg of TriMix in
16065740|NCT02413645|Biological|TriMix_300|300 μg of TriMix in
16065741|NCT02413645|Biological|600μg mRNA (300 μg HIV mRNA+300 μg TriMix mRNA)|600 μg of mRNA (300 μg TriMix + 300 μg HIVACAT)
16065742|NCT02413645|Biological|900μg mRNA (600 μg HIV mRNA+300 μg TriMix mRNA)|900 μg of mRNA (300 μg TriMix + 600 μg HIVACAT)
16065743|NCT02413645|Biological|1200μg mRNA (900 μg HIV mRNA+300 μg TriMix mRNA)|1200 μg of mRNA (300 μg TriMix + 900 μg HIVACAT)
16065744|NCT02413632|Other|creation of a STIs score risk|4 questionnaires 3 screening test ( syphilis, chlamydia, gonorrhea)
16065745|NCT02413632|Other|validation of a STIs score risk|DRIVER questionnaire (DRIVER STI score risk) 3 screening test ( syphilis, chlamydia, gonorrhea)
16065746|NCT02413619|Procedure|Vitrectomy|Vitrectomy
16065747|NCT02413619|Procedure|Cataract surgery|Cataract surgery
16065748|NCT02413619|Procedure|Combined surgery|Combined vitrectomy and cataract surgery at the same time
16065749|NCT02413606|Other|Reduced follow-up schedule|In the intervention group, the follow-up schedule will be limited to four follow-up visits at 3, 12, 24 and 36 months, under the specific condition that patients have easy and prompt access to care (specialised nurse of gynaecologist) if symptoms or questions occur. The content of the follow-up visits will be similar for both groups.
16065750|NCT02413593|Drug|LDV/SOF|90/400 mg FDC tablet administered orally once daily
16065751|NCT02413593|Drug|RBV|Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16065752|NCT02413580|Biological|IGIV-C|An IV dose of 2 g/kg of IGIV-C was administered over 2 consecutive days at a dose of 1 g/kg per day.
16065753|NCT02413567|Device|DMR Procedure (Fractyl)|Endoscopic procedure
16065754|NCT02413554|Drug|Rivastigmine patch|acetylcholine esterase inhibitor
16065755|NCT02413541|Procedure|Polymyxin-B Hemoperfusion|Endotoxin removal
16065756|NCT02413541|Procedure|Standard treatment|
16065757|NCT02413528|Device|Inhaler sensor|Inhaler sensor strap that tracks inhaler use via a pressure sensitive switch.
16065758|NCT02413528|Behavioral|Mobile application for asthma adherence|Mobile phone application that sends reminders, allows patients to see their medication use, and provides points and other incentives for medication use.
16065759|NCT02413515|Drug|Nifedipine (Adalat GITS, BAY1040)|Nifedipine GITS 60 mg tablet, once daily, oral intake, for 8 weeks treatment
16065760|NCT02413502|Biological|BCG|BCG Vaccine USP attenuated live culture for percutaneous use (Merck) at 1-8 x 10^8 CFUs.
16065761|NCT02413489|Drug|Daratumumab|Daratumumab 16 mg/kg will be administered as intravenous infusion to participants once every week for 8 weeks; then once every other week for 16 weeks; thereafter once every 4 weeks until documented progression, unacceptable toxicity, or study end.
16065762|NCT02413476|Procedure|Robotic-assisted Gastrectomy(RAG)|Surgical procedure will be performed with da vinci Surgical System.The type of reconstruction will be selected according to the surgeon's experience.
16065763|NCT02413476|Procedure|Laparoscopic-assisted Gastrectomy(LAG)|Surgical procedure will be performed with laparoscopic techniques.The type of reconstruction will be selected according to the surgeon's experience.
16065764|NCT02413463|Procedure|augmented recession|medial rectus muscle recession using augmented formula ( average of the distance angle with correction and the near angle without correction)
16065765|NCT02413463|Procedure|Faden|medial rectus muscle recession (using the distance angle with correction) with posterior scleral fixation( Faden)
16065766|NCT02413437|Other|CEUS guided biopsy|Biopsy was operated under contrast-enhanced ultrasound-guided.
16065767|NCT02413437|Other|US guided biopsy|Biopsy was operated under conventional ultrasound-guided.
16065768|NCT02413437|Device|Ultrasound|
16065769|NCT02413424|Dietary Supplement|Sucralose|60 ml of 2mM sucralose
16065770|NCT02413424|Other|Water|60 ml of water
16065771|NCT02413424|Dietary Supplement|glucose load|
16065772|NCT02413411|Behavioral|DA/MI Intervention|Patients randomized to the DA/MI intervention arm will be shown a decision aid video entitled, Treatment Choices for Knee Osteoarthritis. Following the viewing of the decision aid video, the participant will be engaged in a motivational interview by the research study interventionist.
16065773|NCT02413411|Behavioral|an educational program (an NIH-developed booklet)|
16065774|NCT02413398|Drug|Dapagliflozin 10 mg|Tablets administered orally once daily for 24 weeks. Randomization will be stratified by pre-enrolment anti-hyperglycemic therapy
16065775|NCT02413398|Drug|Matching Placebo for Dapagliflozin|Matching Placebo for Dapagliflozin tablets administered orally once daily for 24 weeks
16065776|NCT02413385|Behavioral|HealtheSteps Program|6-month evidence-based lifestyle Rx program: At set time points over the 6-month period, participants have in-person visits with a HeS coach at the clinic setting. At each in-person session, the participant receives an individualized Rx for exercise, physical activity (step count) and healthy eating. The HeS Coach and participant then engage in a coaching/goal setting conversation to set detailed plans and goals to achieve their prescriptions. Participants independently choose which activities they will take part in to achieve their lifestyle Rx's and goals. In between in-person sessions, the participants have access to a suite of free-of-charge health technology support tools to: a) track their exercise, physical activity, and healthy eating; and b) receive virtual coaching and support.
16065777|NCT02413372|Drug|BMS-986036|
16065778|NCT02413372|Drug|BMS-986036|
16065779|NCT02413372|Drug|Placebo|
16065780|NCT02413346|Drug|Sarecycline|Administered based on participant's body weight.
16065781|NCT02413333|Device|Clear Care Plus contact lens solution|3% hydrogen peroxide solution with Hydraglyde Moisture Matrix for cleaning, disinfection and overnight storage of contact lenses
16065782|NCT02413333|Device|PeroxiClear contact lens solution|3% hydrogen peroxide solution for cleaning, disinfection and overnight storage of contact lenses
16065783|NCT02413333|Device|Silicone hydrogel contact lenses|2-week/monthly replacement contact lenses per participant's habitual brand
16065784|NCT02413320|Drug|Paclitaxel|
16065785|NCT02413320|Drug|Carboplatin|
16065786|NCT02413320|Drug|Doxorubicin|
16065787|NCT02413320|Drug|Cyclophosphamide|
16065788|NCT02413320|Drug|Docetaxel|
16065789|NCT02413307|Other|Compassion Focused Therapy (self-practice)|Daily practice of the CFT exercises for a minimum of five minutes per day. This is completed for a period of three weeks.
16065790|NCT02413294|Device|Re-Timer glasses|Participants will wear the Re-timer glasses for 30 minutes a day according to their sleep chronotype in weeks 3 and 4 of the study.
16065797|NCT02413242|Other|Various observed exposure(s) of interest|A risk prediction model will be developed to assess which risk factors are associated with the development of ICU pneumonia during ICU stay
16065798|NCT02413229|Drug|DSXS1411|DSXS (Taro Pharmaceuticals Inc.)
16065799|NCT02413229|Drug|Placebo|Placebo (vehicle) (Taro Pharmaceuticals Inc.)
16065800|NCT02413216|Behavioral|TicHelper|TicHelper.com is an 8-week online program designed to teach tic management skills. Content and activities included in TicHelper.com are based on existing empirically-supported treatments including Habit Reversal Training (HRT) and Comprehensive Behavioral Intervention for Tics (CBIT). TicHelper.com is designed to teach tic management skills including psychoeducation, relaxation training, awareness training, competing response training, and social support. It is also designed to teach patients/parents to recognize and reduce tic-exacerbating reactions and activities.
16065801|NCT02413216|Other|Internet Based Resources|The Internet-Based Resources (IBR) condition is designed to provide patients/parents with access to a wide range of educational materials. These materials contain up-to-date information regarding what is known about tic disorders and their management. Materials covering medical, educational, and behavioral/psychological topics are provided.
16065802|NCT02413203|Drug|Celecoxib|Blood and urine collections before and 3 hours after celecoxib administration.
16065803|NCT02413203|Drug|Placebo|Blood and urine collections before and 3 hours after placebo administration.
16065804|NCT02413177|Behavioral|EEG-no RTNF|All EEG sessions are done on an individual basis. Group 2 will receive EEG (no RTNF) at weeks 3, 4, 6, and 7 of MBSR. At these time points, subjects will take part in a 1-hour EEG-RTNF session., comprised of six 3.5-minute runs. Each run will begin with a 30-second active baseline task in which subjects view adjectives and think about and decide if the word describes them. Following baseline, subjects will meditate for 3 to 7 minutes with EEG-RTNF. All subjects will be instructed to practice meditation during EEG-RTNF training, and to keep their eyes closed.
16065805|NCT02413177|Behavioral|EEG-RTNF|All EEG sessions are done on an individual basis. Group 1 will receive EEG-RTNF training from the PCC at weeks 3, 4, 6, and 7 of MBSR. At these time points, subjects will take part in a 1-hour EEG-RTNF session., comprised of six 3.5-minute runs. Each run will begin with a 30-second active baseline task in which subjects view adjectives and think about and decide if the word describes them. Following baseline, subjects will meditate for 3 to 7 minutes with EEG-RTNF. All subjects will be instructed to practice meditation during EEG-RTNF training, and to keep their eyes closed.
16065806|NCT02413164|Other|A multimodal physiotherapy programme|"Intervention: individualised Multimodal Physiotherapy Programme of therapeutic exercises with education healthy-style-of-life based.
~Groupal sessions two times per week during 12 weeks. Each session 60 minutes: 10 minutes of warm up, 20 minutes of strength and muscular endurance, 20 minuts of aerobic training, 10 minutes of cold-down.
~Intensity aerobic training: The training heart rate will be calculated according to recommendations of the American College of Sport Medicine (ACSM), it must oscillate between 55/65% and 90% of the HRmax. Initial four weeks: moderate intensity (55-69% HRmax); Following weeks according to each response, to higher level of training (70-89% HRmax). Strength training: individualised working with the principal muscular groups. 3 sessions using a weight which can repeat the exercise 10-15 times, increasing to a weight at which they can repeat the exercise 8-12 times."
16065807|NCT02413151|Behavioral|Exercise training program|The exercise sessions will be hospital-based, 3 times a week for 60 minutes each, on non-consecutive days for 6 months. Selected the aerobic interval training (AIT) method for the development of cardiopulmonary system and the inclusion of resistance and sensorimotores exercises. The AIT comprises 4 interval training periods (high intensity) and 3 active pauses (moderate intensity) between interval training periods. The patient will warmup for 10 minutes at 50% to 60% of HRpeak from CPET, before walking to four 4 minutes intervals at 90 to 95% of peak HR. Each interval, including the last one, is separate by 3 minutes active pauses, walking at 60% to 70% of HRpeak. Total aerobic exercise time at this moment will be 28 minutes and will be maintain to the end of ExT intervention period.
16065808|NCT02413151|Device|Cardiac resynchronization therapy (CRT)|Implantation will be performed according to standard techniques of biventricular pacing. The CRT includes a generator and three leads, used to correct ventricular dyssynchrony.
16065809|NCT02413138|Drug|Somavaratan (VRS-317)|Long acting recombinant human growth hormone
16065810|NCT02413125|Device|ChitoRhino irrigation solution|ChitoRhino irrigation solution has been developed with chitosan, a natural polysaccharide demonstrated to have antibacterial and antifungal properties. This polysaccharide has beneficial properties in multiple clinic applications including wound healing and post-operative sinus surgery. Chitosan's antimicrobial function develops from its polycationic structure. Chitosan interacts with the negatively charge bacterial wall, leading to disruption and cell lysis.
16065811|NCT02413125|Drug|Normal saline|Most nasal irrigations use normal saline (0.9% sodium chloride), which approximates the physiological concentration of plasma in the blood. The saline solution is used to flush the nose of mucous and allergens.
16065812|NCT02413112|Behavioral|Resistance training|"Whole-body resistance training in the University gym that is supervised by researchers.
~Training once per week, Training twice per week, Training thrice per week."
16065813|NCT02413099|Drug|KBMSI-2|The KBMSI-2 capsules (6gm/capsule) and placebo were provided by Korean Bio Medical Science Institute (Seoul, Korea). KBMSI-2 was analyzed by high-performance liquid chromatography. KBMSI-2 contained major ginsenoside-Rb1: 260.53ug/g, -Rb2: 543.91ug/g, -Rc: 424.92ug/g, -Re: 377.32ug/g, -Rf: 1160.55ug/g, -Rg1: 703.97ug/g, Curcumin 60.73ug/g, Allantoin 98.66ug.g, and Loganin 744.13ug/g. During the study period, two capsules were taken daily for 8 weeks. The placebo capsules were identical in shape, color, and taste.
16065814|NCT02413086|Procedure|Early-stage amputation|Individuals with DFU were given early-stage amputation.
16065815|NCT02413086|Procedure|Amputation|Individuals with DFU were given amputation.
16065816|NCT02413086|Other|External herbs chitosan|Wound was given external herbs chitosan after amputation.
16065817|NCT02413086|Other|Traditional gauze|Wound was given traditional gauze after amputation.
16065818|NCT02413073|Procedure|Whole Body Vibration|We wil use vibration in patients with kidney disease
16065819|NCT02413060|Other|Resistance training|This training consists 4 exercises and every exercises lasts 5 seconds.
16065820|NCT02413060|Behavioral|Lifestyle counselling|Lifestyle counselling mainly indicates dietary instruction.
16065821|NCT02413047|Drug|Azathioprine|Medication will be given in pill form to patients to take daily as long as the patient has not been intolerant to it in the past.
16065822|NCT02413047|Drug|6 mercaptopurine|Medication will be given in pill form to patients to take daily as long as the patient has not been intolerant to it in the past as an alternative to imuran
16065823|NCT02413047|Drug|Methotrexate|Medication will be given in subcutaneous injection form once a week if the patient cannot take imuran or 6 mercaptopurine.
16065824|NCT02413034|Drug|Cefazolin|Cefazolin (vancomycin in the case of allergy to cefazolin)
16065825|NCT02413034|Other|Control group|no antibiotic prophylaxis
16065826|NCT02413021|Drug|Cytarabine|20 mg/m^2 , SC, two times a day for 10 days every 30 days for 1 cycle
16065827|NCT02413021|Drug|Deferasirox|20 mg/kg ,oral, per day
16065828|NCT02413008|Drug|estriol|0.005% estriol vaginal gel
16065829|NCT02413008|Drug|Placebo|placebo vaginal gel
16065830|NCT02412995|Other|Meal sequence 1-2-3|The subjects were studied in three 2 h meal tests with a subsequent ad libitum meal on separate days, at least two days apart. The subjects were individually randomised to the sequence of the test meals using random permutation. The study included two berry meals based on 150 g of frozen berries; sea buckthorn (Hippophaë rhamnoides) and strawberry (Fragaria x ananassa), respectively, and one control meal which did not contain berries. Each meal contained 35 g of sucrose and was adjusted for protein and fat with whey protein and canola oil, respectively. The meals were served with 120 mL of water.
16065831|NCT02412995|Other|Meal sequence 1-3-2|The subjects were studied in three 2 h meal tests with a subsequent ad libitum meal on separate days, at least two days apart. The subjects were individually randomised to the sequence of the test meals using random permutation. The study included two berry meals based on 150 g of frozen berries; sea buckthorn (Hippophaë rhamnoides) and strawberry (Fragaria x ananassa), respectively, and one control meal which did not contain berries. Each meal contained 35 g of sucrose and was adjusted for protein and fat with whey protein and canola oil, respectively. The meals were served with 120 mL of water.
16065832|NCT02412995|Other|Meal sequence 2-3-1|The subjects were studied in three 2 h meal tests with a subsequent ad libitum meal on separate days, at least two days apart. The subjects were individually randomised to the sequence of the test meals using random permutation. The study included two berry meals based on 150 g of frozen berries; sea buckthorn (Hippophaë rhamnoides) and strawberry (Fragaria x ananassa), respectively, and one control meal which did not contain berries. Each meal contained 35 g of sucrose and was adjusted for protein and fat with whey protein and canola oil, respectively. The meals were served with 120 mL of water.
16065833|NCT02412995|Other|Meal sequence 2-1-3|The subjects were studied in three 2 h meal tests with a subsequent ad libitum meal on separate days, at least two days apart. The subjects were individually randomised to the sequence of the test meals using random permutation. The study included two berry meals based on 150 g of frozen berries; sea buckthorn (Hippophaë rhamnoides) and strawberry (Fragaria x ananassa), respectively, and one control meal which did not contain berries. Each meal contained 35 g of sucrose and was adjusted for protein and fat with whey protein and canola oil, respectively. The meals were served with 120 mL of water.
16065834|NCT02412995|Other|Meal sequence 3-1-2|The subjects were studied in three 2 h meal tests with a subsequent ad libitum meal on separate days, at least two days apart. The subjects were individually randomised to the sequence of the test meals using random permutation. The study included two berry meals based on 150 g of frozen berries; sea buckthorn (Hippophaë rhamnoides) and strawberry (Fragaria x ananassa), respectively, and one control meal which did not contain berries. Each meal contained 35 g of sucrose and was adjusted for protein and fat with whey protein and canola oil, respectively. The meals were served with 120 mL of water.
16065835|NCT02412995|Other|Meal sequence 3-2-1|The subjects were studied in three 2 h meal tests with a subsequent ad libitum meal on separate days, at least two days apart. The subjects were individually randomised to the sequence of the test meals using random permutation. The study included two berry meals based on 150 g of frozen berries; sea buckthorn (Hippophaë rhamnoides) and strawberry (Fragaria x ananassa), respectively, and one control meal which did not contain berries. Each meal contained 35 g of sucrose and was adjusted for protein and fat with whey protein and canola oil, respectively. The meals were served with 120 mL of water.
16065838|NCT02412969|Procedure|Lumbar Epidural|control group will receive lumbar puncture epidural
16065839|NCT02412969|Procedure|Dural Puncture Epidural|intervention group will receive a dural puncture epidural
16065840|NCT02412956|Behavioral|SmokefreeMOM Text|
16065841|NCT02412943|Other|Fresh Frozen Plasma|Liquid portion of human blood that was centrifuged, separated, and frozen solid within 6 hours of collection
16065842|NCT02412930|Procedure|Ultrasound-guided Paravertebral Block|"paravertebral block was performed by ultrasound guidance at T11, T12 and L1 levels, using 0.5% bupivacaine total dose of 15 mL in group P. The injection site was covered with sterile drapes, after cleaning with 10% povidone-iodine solution.
~After, patients in both groups were performed patient controlled analgesia (PCA). The PCA was prepared with 400 mg tramadol into 100 mL of saline. The doses of tramadol in the PCA were bolus dose 0.1 mgkg-1 every 20 minutes without a background infusion."
16065843|NCT02412930|Drug|Group Tramadol|Patients in group T were given intravenously a loading dose of tramadol of 1 mgkg-1, 45 minutes before the end of surgery. After,patients in both groups were performed patient controlled analgesia (PCA). The PCA (CADD Legacy PCA pump, Smiths Medical MD, Inc., St. Paul, MN) was prepared with 400 mg tramadol into 100 mL of saline. The doses of tramadol in the PCA were bolus dose 0.1 mgkg-1 every 20 minutes without a background infusion.
16065844|NCT02412930|Drug|Bupivacaine|
16065845|NCT02412930|Device|Ultrasound|
16065846|NCT02412917|Drug|FV-100|antiviral nucleoside analog
16065847|NCT02412917|Drug|valacyclovir|antiviral nucleoside analog
16065848|NCT02412904|Drug|rFSH|the patients will be asked to schedule an ultrasound in the first three days of the menstrual cycle and starts the ovarian stimulation with the previous randomized selected gonadotropin (rFSH or hMG) using a dose between 150 - 300 IU according with their AMH and antral follicle count (AFC). This dose will be maintained until day 6 of stimulation, when a second ultrasound will be performed and the GnRH antagonist will be initiated and continued until the end of the cycle. Seriated ultrasounds will be performed each two days
16066138|NCT02410863|Drug|Dabrafenib|150 mg twice daily
16065849|NCT02412904|Drug|HMG|the patients will be asked to schedule an ultrasound in the first three days of the menstrual cycle and starts the ovarian stimulation with the previous randomized selected gonadotropin (rFSH or hMG) using a dose between 150 - 300 IU according with their AMH and AFC. This dose will be maintained until day 6 of stimulation, when a second ultrasound will be performed and the GnRH antagonist will be initiated and continued until the end of the cycle. Seriated ultrasounds will be performed each two days
16065850|NCT02412891|Device|UroShield device|The UroShield device is Consists of two units:Actuator and Driver.
16065851|NCT02412891|Device|Sham UroShield device|
16065852|NCT02412878|Drug|Carfilzomib|Carfilzomib was administered as an IV infusion
16065853|NCT02412878|Drug|Dexamethasone|Commercially available dexamethasone was obtained by the investigational site.
16065854|NCT02412865|Behavioral|Quit4Baby|
16065855|NCT02412865|Behavioral|Text4Baby|
16065856|NCT02412852|Drug|Sodium nitrite|Sustained release formulation of sodium nitrite
16065857|NCT02412852|Drug|Placebo|Placebo tablets containing same excipients and coatings used in the active tablets, without sodium nitrite being added.
16065858|NCT02412826|Device|Abstats sensor|The AbStats abdominal biosensor will be applied to the abdomen of patients who are admitted with acute pancreatitis.
16065859|NCT02412813|Device|LEGION OXINIUM|Investigational Group
16065860|NCT02412813|Device|LEGION Cobalt Chrome|Control Group
16065861|NCT02412787|Drug|Idursulfase-IT|Participants will receive 10 mg of idursulfase-IT intrathecally via IDDD or LP once every 28 days. Participants who are younger than 3 years of age will receive an adjusted dose of 7.5 mg (>8 months to 30 months of age) and 10 mg (>30 months to 3 years of age).
16065862|NCT02412787|Drug|Elaprase|Participants will receive intravenous (IV) Elaprase infusions at a minimum of 48 hours after IT administration of idursulfase-IT.
16065863|NCT02412774|Behavioral|DBs at the end of the main meal + Diet|Subjects are asked to have 250 ml DBs at the end of their lunch as the main meal, while they are on a multidisciplinary diet plan for 24 weeks.
16065864|NCT02412774|Behavioral|Water at the end of the main meal+ Diet|Subjects are asked to have 250 ml water at the end of their lunch as the main meal, while they are on a multidisciplinary diet plan for 24 weeks.
16065865|NCT02412761|Drug|Lisinopril|Initial dose: 0.1 mg/kg/dose orally, once daily (maximum initial dose 10 mg/dose). Maximum final dose: 40 mg/dose or 0.6 mg/kg/dose.
16065866|NCT02412761|Drug|Amlodipine|Initial dose: 0.1 mg/kg/dose orally, once daily (maximum initial dose 5 mg/dose). Maximum final dose: 10 mg/dose
16065867|NCT02412761|Drug|Hydrochlorothiazide|Initial dose: 1 mg/kg/dose orally, once daily (maximum initial dose 25 mg/dose). Maximum final dose: 50 mg/dose or 3 mg/kg/dose
16065868|NCT02412748|Behavioral|BBTF Intervention|The Building Bridges to Fatherhood (BBTF) intervention consists of 9 group sessions and 1 booster session as described in the arm/group descriptions.
16065869|NCT02412748|Behavioral|Financial Literacy Program|The Financial Literacy Program (FLP) attention control condition consists of 9 group sessions and 1 booster session as described in the arm/group descriptions.
16065870|NCT02412735|Drug|rexlemestrocel-L|"rexlemestrocel-L alone: 2.0 mL formulation of approximately 6 million rexlemestrocel-L cells - Intervention will be injected into the painful intervertebral disc"
16065871|NCT02412735|Drug|rexlemestrocel-L + HA|"rexlemestrocel-L + HA: 2.0mL 6 million rexlemestrocel-L cells with 1% HA - Intervention will be injected into the painful intervertebral disc"
16065872|NCT02412735|Drug|Placebo|saline control: 2.0 mL saline solution
16065873|NCT02412722|Drug|Sapanisertib|Sapanisertib capsules
16065874|NCT02412722|Drug|Paclitaxel|Paclitaxel injection
16065875|NCT02412709|Device|QTScreen ECG Recorder|Subjects will be randomly assigned to the: Parents Performing ECG (PPE) group or Staff Performing ECG (SPE) group. This will assess whether parents are able to use QTScreen on babies at home.
16065876|NCT02412696|Device|Positive Airway Pressure|Auto-titrating PAP + nasal dilator strips during sleep
16065877|NCT02412696|Other|Nasal Dilator Strips|Nasal dilator strips
16065878|NCT02412683|Other|oxaliplatin|
16065879|NCT02412670|Drug|Methotrexate|Given IV
16065880|NCT02412670|Drug|Vinblastine|Given IV
16065881|NCT02412670|Drug|Doxorubicin|Given IV
16065882|NCT02412670|Drug|Cisplatin|Given IV
16065883|NCT02412670|Drug|Gemcitabine|Given IV
16065884|NCT02412670|Drug|Carboplatin|Given IV
16065885|NCT02412670|Drug|Pegfilgrastim|Administered subcutaneously
16065886|NCT02412670|Procedure|Nephroureterectomy|Undergo nephroureterectomy and lymph node dissection
16065887|NCT02412657|Drug|Dexamethasone|After the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v.
16065888|NCT02412657|Drug|Normal Saline|
16065889|NCT02412644|Drug|apremilast|
16065890|NCT02412631|Drug|lorcaserin|lorcaserin is an FDA-approved weight loss medication for overweight and obese patients
16065891|NCT02412631|Drug|Varenicline|Chantix is an FDA approved medication for smoking cessation
16065892|NCT02412631|Drug|Placebo|Placebo for lorcaserin
16065893|NCT02412618|Drug|Mifepristone|Progesterone antagonist
16065894|NCT02412618|Drug|Misoprostol|Prostaglandin E1
16065895|NCT02412618|Dietary Supplement|Placebo|Tasteless, odorless, sugar based pill
16065896|NCT02412605|Procedure|Trophectoderm embryo biopsy|"Day 5 embryos were incubated in calcium/Magnesium free culture. A laser beam was used to produce a hole in the zona pellucida. Trophectoderm cells were collected by gentle suction using the biopsy pipette.
~Florescent in situ hybridization of the trophectoderm nuclei with probes specific to the X- and Y-chromosomes was performed. the embryos were frozen and the cycles deferred.The embryos were thawed in the following cycle and if possible 2 embryos of the desired sex were transferred."
16065897|NCT02412579|Other|None - Standard of Care|
16065898|NCT02412566|Drug|SMOFlipid|Therapy with SMOFlipid will be provided at a targeted dose of 3 gm/kg/day (by continuous infusion). SMOFlipid will be initiated and advanced according to the following guidelines: Day 1 - provide 1 g/kg; Day 2 - provide 2 g/kg; Day 3 - provide 3 g/kg. SMOFlipid will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition.
16065901|NCT02412540|Behavioral|Comprehensive Lifestyle Intervention|Dietary, behavioral and activity interventions designed to reduce weight.
16065902|NCT02412527|Other|Patch III heart rate sensor|
16065903|NCT02412514|Biological|bOPV (three dose)|bOPV administered at 6, 10, and 14 weeks of age.
16065904|NCT02412514|Biological|bOPV (two dose)|bOPV administered at 10 and 14 weeks of age.
16065905|NCT02412514|Biological|IPV|IPV administered at 6 weeks of age
16065906|NCT02412501|Device|Resolute Onyx Stent - 2.0 mm|Clinical Evaluation of the Medtronic Resolute Onyx Zotarolimus-Eluting 2.0 mm Stent
16065907|NCT02412488|Other|Out of cathlab insertion|"Insertion of the Reveal LINQ device in the out-of-cathlab setting (out of the operating room, cardiac catheterization or electrophysiology laboratory)."
16065908|NCT02412475|Drug|Decitabine|Dosing per protocol starting at hour 0 IV infusion over 1 hour on Days 1-5
16065909|NCT02412475|Drug|Vorinostat|180 mg per meter squared per day for those under age 18, 300mg BID for those age 18 and older. Given after the decitabine infusion by mouth on Days 1-5
16065910|NCT02412475|Drug|Fludarabine|30 mg per meter squared per day starting at hour 0 given immediately after G-CSF by IV infusion over 30 minutes on days 6-10
16065911|NCT02412475|Drug|Cytarabine|2000 mg per meter squared per day starting at hour 4 by IV over 3 hours on days 6-10
16065912|NCT02412475|Drug|Filgrastim|5 μ/kg/dose starting at hour 0 immediately before fludarabine by IV or SQ on days 5-12
16065913|NCT02412475|Drug|Cytarabine|"Patient Age (years) IT Cytarabine Dose > 1 30 mg
~2 and < 3 50 mg
~3 and ≤ 18 70 mg > 18 100 mg
~given IT on day 0 or -1"
16065914|NCT02412475|Drug|Sorafenib|150 mg/m2/dose twice daily by mouth on days 11-28
16065915|NCT02412462|Drug|AB-16B5|
16065916|NCT02412449|Drug|AKB-6548 tablet, reference formulation given in the fasted state|
16065917|NCT02412449|Drug|AKB-6548 tablet, test formulation given in the fasted state.|
16065918|NCT02412449|Drug|AKB-6548 tablet, test formulation given in the fed state|
16065919|NCT02412436|Drug|Depot medroxyprogesterone acetate|Depot medroxyprogesterone acetate intramuscular injection
16065920|NCT02412423|Drug|post-transplantation cyclophosphamide|
16065921|NCT02412410|Behavioral|Fatigue avoidance education|Grand Rounds presentation of consequences of fatigue and fatigue avoidance techniques
16065922|NCT02412397|Procedure|Total Shoulder Arthroplasty|
16065923|NCT02412384|Other|Flow cytometry (FCM)|Use FCM to test PBMCs/CTCs from volunteers/patients.
16065924|NCT02412384|Other|RT-PCR|Use RT-PCR to test PBMCs/CTCs from volunteers/patients.
16065925|NCT02412371|Drug|Paclitaxel|Administered via intravenous infusion on Day 1 of each treatment week (concurrent CRT) / cycle (consolidation)
16065926|NCT02412371|Drug|Placebo for Veliparib|Capsule for oral administration
16065927|NCT02412371|Drug|Carboplatin|Administered via intravenous infusion on Day 1 of each treatment week (concurrent CRT) / cycle (consolidation)
16065928|NCT02412371|Drug|Veliparib|Capsule for oral administration
16065929|NCT02412371|Radiation|Radiotherapy|Radiation treatment with total dose of 60 - 63 Gy administered on Days 1 to 5 of each week for 7 weeks
16065930|NCT02412358|Device|toothbrush|
16065931|NCT02412345|Procedure|Extracorporeal shockwave therapy|
16065932|NCT02412345|Procedure|Extracorporeal shockwave therapy - sham treatment|A probe similar to the treatment group will be used. The noise and appearance is similar. The probe emits zero energy during each treatment. Local application generates noise and a feeling of popping at the application site which will also be experienced by patients in the placebo group being impossible for the patient to discern which treatment group belongs.
16065933|NCT02412345|Other|Penile ultrasound Doppler with intracavernosal injection application 20 mcg alprostadil|Diagnostic test will be performed before treatment and after 3 to 4 months after therapy.
16065934|NCT02412332|Procedure|Bone marrow harvesting|Approximately 200 mL of bone marrow will be surgically collect from the iliac crest (pelvis) of the patient under spinal anesthesia.
16065935|NCT02412332|Procedure|Liposuction|Approximately 50 mL of adipose tissue (fat) will be surgically collected from the abdominal region of the patient under spinal anesthesia.
16065936|NCT02412319|Drug|Anti-HBV placenta transfer factor injection|Anti-HBV Placenta Transfer Factor Injection: 2mg/4ml, intramuscular injection, the 0-24 week, once every other day; week 24-48, 2 times / week; entecavir tablets: 0.5mg/ tablet / time, daily bedtime fasting oral once, treatment course 96 weeks
16065937|NCT02412319|Other|Placebo|Physiological saline injection: 2mg/4ml, intramuscular injection,the 0-24 week, once every other day, week 24-48, 2 times / week; entecavir tablets: 0.5mg/ tablet / time, daily bedtime fasting oral once, treatment course 96 weeks
16065938|NCT02412306|Drug|Blinatumomab|Continuous intravenous infusion over four weeks per treatment cycle
16065939|NCT02412293|Behavioral|Health Education & Promotion|Promotion of antenatal care, adequate nutrition, skilled delivery and healthy newborn care practices at household level.
16065940|NCT02412293|Other|Training of Health Workers|Training of health workers on recognition of danger sign that warrant referral to health care service.
16065941|NCT02412293|Behavioral|Community Mobilization|Community mobilization activities included formation of community health committees and creation of support for the uptake of the interventions.
16065942|NCT02412280|Other|retrospecive observational|
16065943|NCT02412267|Drug|O-ICE (ofatumumab, Ifosfamide, Carboplatin, Etoposide)|Ofatumab in combination with ICE (Ifosfamide, Carboplatin, Etoposide) are given to subjects according to protocol schedule
16065944|NCT02412254|Other|Best practices hearing rehabilitative treatment|Intervention comprises hearing needs assessment, counselling, sensory management with amplification devices, and rehabilitative training.
16065945|NCT02412254|Other|Successful aging intervention|One-on-one education sessions on healthy aging topics (cancer screening, smoking cessation, etc.) between a trainer and participant
16065946|NCT02412241|Other|LEF measures|Patient-reported outcome measure; clinician-reported outcome measures
16065947|NCT02412241|Procedure|Technical measure|Undergo standard CT scan
16065948|NCT02412241|Procedure|Technical measure|Undergo standard ultrasound
16065949|NCT02412228|Drug|Ixazomib|"Cycle 1:
~Ixazomib: 4mg/day 1, 8, 15
~Cycles 2-6:
~Ixazomib: 4mg/day 1, 4, 8, 11, 15, 18,
~Maintenance:
~Ixazomib at 4 mg days 1, 8 and 15 of a 28 day cycle for 1 ½ years"
16066139|NCT02410863|Drug|Trametinib|2 mg daily
16065950|NCT02412228|Drug|Cyclophosphamide|"Cycle 1:
~Cyclophosphamide: 50 mg/day continuous daily
~Cycles 2-6:
~Cyclophosphamide: 50 mg/day continuous daily"
16065951|NCT02412228|Drug|Dexamethasone|"Cycle 1:
~Dexamethasone: 20 mg/day 1, 8, 15
~Cycles 2-6:
~Dexamethasone: 20 mg/day 1, 4, 8, 11, 15, 18"
16065952|NCT02412215|Procedure|Phacoemulsification with toric Nanoflex IOL implantation|A self-sealing incision is made with a 2.2mm knife at 110°. Phacoemulsification is performed. The foldable nanoFlex toric IOL is injected in the capsular bag using the nanoPoint single-use injector system (STAAR) or 1620 sofTip Injector (ASICO). The IOL is rotated to align the cylinder axis with the steep corneal meridian using Z align function by Callisto Eye. Every movement of the IOL axis marks are noted.
16065953|NCT02412215|Device|NanoFlex toric Intraocular Lens|
16065954|NCT02412202|Other|Monitoring of pulmonary oedema induced by weaning from mechanical ventilation|
16065955|NCT02412189|Procedure|Maintained blood pressure|Norepinephrine therapy to maintain preanesthesia blood pressure
16065956|NCT02412189|Drug|Norepinephrine|Norepinephrine therapy to maintain preanesthesia blood pressure
16065957|NCT02412176|Procedure|Pacing site - the implantation in the right ventricular (RV) apex|Pacing site - RV apex. The lead will be implanted in the RV apex.
16065958|NCT02412176|Procedure|Pacing site - the implantation in the septum|Pacing site - septum. The lead will be implanted in the septum.
16065959|NCT02412163|Device|Ellipse IM HTO Nail|
16065960|NCT02412150|Drug|Desflurane|Anesthesia is maintained with desflurane
16065961|NCT02412150|Drug|Remifentanil|Remifentanil is infused for the maintenance of anesthesia during surgery and discontinued 15 min before end of surgery
16065962|NCT02412150|Procedure|Thyroidectomy|The aim of this study is evaluation of effect of dexmedetomidine on emergence response and postoperative outcome after thyroidectomy
16065963|NCT02412150|Other|Vital signs|"Systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate are measured before infusion of testing drugs, after infusion of them (5 min, 10 min, and 15 min), during extubation (0 min and 5 min after extubation), and at recovery room.
~And the complications such as hypotension, hypertension, bradycardia, tachycardia, and desaturation after infusion of testing drugs are observed."
16065964|NCT02412150|Behavioral|Cough reflex|During recovery from anesthesia at operation room, cough reflex is measured and rated. [Grade 0, no cough; Grade 1, single cough with mild severity; Grade 2, cough persistence less than 5 s with moderate severity; Grade 3, severe, persistent cough for more than 5 s (bucking)]
16065965|NCT02412150|Behavioral|Ramsay Sedation Scale|"When the patient has fully awaken and transferred to the recovery room, Ramsay Sedation Scale is measured.
~Awake Patient anxious and agitated or restless or both!
~Patient cooperative, oriented and tranquil!
~Patient responds to commands only!
~Asleep A brisk response to a light glabellar tap or loud auditory stimulus!
~A sluggish response to a light glabellar tap or loud auditory stimulus!
~No response to a light glabellar tap or loud auditory stimulus"
16065966|NCT02412150|Other|Extubation time and Recovery time|"The time from discontinuing anesthetic gas to endotracheal extubation is measured.
~And the time from the discontinuing of anesthetic gas to transferring to the recovery room is also measured."
16065967|NCT02412150|Behavioral|Visual analogue scale|The severity of pain after surgery is measured by VAS (at recovery room, POD 1, POD 2, and POD 3)
16065968|NCT02412150|Other|Postoperative bleeding|The amount of postoperative bleeding which is collected in the barovac is measured.
16065969|NCT02412150|Other|Postoperative complications|Postoperative complications after thyroidectomy such as hoarseness and hematoma, and reoperation due to such complication is observed.
16065970|NCT02412150|Other|Time to remove drainage and duration of hospital staying|The time from the end of surgery to remove drainage is measured. And the duration of hospital staying is measured.
16065971|NCT02412150|Drug|Dexmedetomidine|Dexmedetomidine has started infusion for 15 min (rate of 0.6 ug/kg/hr) before end of surgery as experimental intervention
16065972|NCT02412150|Drug|Normal saline|Normal saline has started infusion for 15 min (as same rate of dexmedetomidine) before end of surgery as control intervention
16065973|NCT02412137|Other|Counseled cohort|This group will be counseled after brace temperature/date/time data is logged at each visit.
16065974|NCT02412124|Procedure|Supportive Care|Complete W2W mentoring program
16065975|NCT02412124|Other|Quality-of-Life Assessment|Complete the FACT-G
16065976|NCT02412124|Other|Questionnaire Administration|Complete the W2W Patient Survey
16065977|NCT02412111|Drug|Ivacaftor|
16065978|NCT02412111|Drug|Tezacaftor/Ivacaftor|
16065979|NCT02412098|Drug|Eleclazine|Eleclazine tablets administered orally
16065980|NCT02412085|Drug|Golimumab|"Subcutaneous golimumab. Induction regimen: 200 mg (week 0), 100 mg (week 2)
~Maintenance regimen:
~body weight < 80kg: 50 mg every 4 weeks
~body weight ≥ 80 kg: 100 mg every 4 weeks"
16065981|NCT02412059|Drug|Prednisolone acetate|
16065982|NCT02412046|Procedure|Muscle biopsy|
16065983|NCT02412033|Drug|Misoprostol|400 µg misoprostol vaginally 3 hours before IUD insertion.
16065984|NCT02412033|Drug|Placebo|This group will receive placebo
16065985|NCT02412020|Drug|PA101|
16065986|NCT02412020|Drug|Placebo|
16065987|NCT02412007|Other|Individualized comprehensive home centred activity based programme|"Simple activities would be advised on the basis of child's individual characteristics and parental expectations. These would include but would not be limited to
~Standing up from squatting position to catch an object of interest.
~Squatting from standing position to pick an object of interest.
~Walking to reach an object of interest.
~Climbing up steps to get an object of interest.
~Climbing down steps to keep the above object of interest.
~Cycling
~Kicking a football
~Dancing"
16065988|NCT02411994|Drug|Pyronaridine-artesunate|
16065989|NCT02411994|Drug|Artemether-lumefantrine combination|
16065990|NCT02411981|Other|Autogenic drainage|
16065991|NCT02411968|Other|111In-Girentuximab DOTA SPECT|
16065992|NCT02411955|Drug|Tazarotene Cream 0.1%|Tazarotene Cream 0.1% applied to lightly cover the entire face once daily for 84 consecutive days.
16065993|NCT02411955|Drug|Tazorac®|Tazorac® applied to lightly cover the entire face once daily for 84 consecutive days.
16065994|NCT02411955|Drug|Placebo|Placebo (vehicle of the test product) applied to lightly cover the entire face once daily for 84 consecutive days.
16066140|NCT02410850|Device|Oral Appliance|Mandibular Advancement Splints
16065995|NCT02411942|Drug|Adapalene Gel 0.3%|Adapalene Gel 0.3% applied to the entire face once daily for 84 consecutive days
16065996|NCT02411942|Drug|Differin®|Differin® applied to the entire face once daily for 84 consecutive days
16065997|NCT02411942|Drug|Placebo|Placebo (vehicle of the test product) applied to the entire face once daily for 84 consecutive days
16065998|NCT02411929|Drug|Unlabeled ertugliflozin for oral use|15 mg oral (3 x 5 mg tablets)
16065999|NCT02411929|Drug|14^C-labeled ertugliflozin for IV use|100 µg (10 µg/mL solution IV) containing approximately 400 nCi 14^C (ie, radiolabeled ertugliflozin)
16066000|NCT02411929|Drug|14^C-labeled ertugliflozin for oral use|100 µg (10 µg/mL solution oral) containing approximately 400 nCi 14^C (ie, radiolabeled ertugliflozin)
16066001|NCT02411916|Biological|misoprostol|rectal insertion
16066002|NCT02411903|Drug|atorvastatin and clopidogrel|Dose: atorvastatin 40mg/d plus clopidogrel 75mg/d for 9 months.
16066003|NCT02411903|Drug|rosuvastatin and clopidogrel|Dose: rosuvastatin 20mg/d plus clopidogrel 75mg/d for 9 months.
16066004|NCT02411890|Procedure|Adductor canal block (active)|adductor canal block: single injection, 0.5% levobupivacaine 15 ml with adrenaline 5 µg/ml, ultrasound guidance with nerve stimulator
16066005|NCT02411890|Procedure|Femoral nerve block (active)|femoral nerve block: single injection, 0.25% levobupivacaine 30 ml with adrenaline 5 µg/ml, ultrasound guidance with nerve stimulator
16066006|NCT02411890|Procedure|Femoral nerve block (sham block)|30 mL of normal saline injected into absorbing cloth through stump needle at the inguinal area but not penetrating skin, ultrasound guidance and nerve stimulator with percutaneous electronic guidance to create quadriceps contraction before injection
16066007|NCT02411890|Procedure|Adductor canal block (sham block)|30 mL of normal saline injected into absorbing cloth through stump needle at the midfemoral area but not penetrating skin, ultrasound guidance and nerve stimulator with percutaneous electronic guidance without muscle contraction
16066008|NCT02411877|Procedure|Normothermia|Device: Trevo Pro Retriever (Stryker Corp.)
16066009|NCT02411877|Procedure|Mild hypothermia|Device: Zoll Thermogard XP technology with the Quattro catheter Device: Trevo Pro Retriever (Stryker Corp.)
16066010|NCT02411877|Device|Trevo Pro Retriever (Stryker Corp.)|Device: Trevo Pro Retriever (Stryker Corp.)
16066011|NCT02411877|Device|Zoll Thermogard XP technology with the Quattro catheter|Device: Zoll Thermogard XP technology with the Quattro catheter
16066012|NCT02411864|Other|different low b-values distribution|
16066013|NCT02411851|Drug|ingenol mebutate 0.015%|one cycle of ingenol mebutate 0.015% on two 25 cm2 treatment areas
16066014|NCT02411851|Other|dermasil lotion|Dermasil lotion has 1% dimethicone as its active ingredient - part of the family of silicone oils, is a hypoallergenic, noncomedogenic, and nonacnegenic agent
16066015|NCT02411838|Other|Calorie restriction|"Calorie restriction will be achieved by alternate day fasting. During the day of fasting the subject will be allowed to eat two salads with light dressing, not to go over approximately 500 calories. The CR group subjects will fast on day 2 (second day of steroids) and then continue to fast on alternate days until day 15. This is the end of the Acute CR phase of the Study, and patients may discontinue the study at this point.
~Chronic CR phase At the end of the Acute CR phase, both groups will be offered to enroll in the alternate day fasting regimen for 6 months (Chronic CR phase). During this phase, patients with a BMI <28 will follow a regimen of fasting for two days per week while patients with BMI>28 will follow a regimen of fasting for three days per week."
16066016|NCT02411825|Drug|SAR425899|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous"
16066017|NCT02411825|Drug|placebo|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous"
16066018|NCT02411825|Drug|metformin|"Pharmaceutical form: tablet
~Route of administration: oral"
16066019|NCT02411812|Device|Herbst appliance with skeletal anchorage|Group treated with the Herbst appliance with indirect skeletal anchorage in mini-implants.
16066020|NCT02411812|Device|Herbst appliance with dental anchorage|Group treated with the conventional Herbst appliance with dental anchorage.
16066021|NCT02411812|Device|Twin-Block appliance|Group treated with Twin-Block appliance
16066022|NCT02411786|Biological|pTVG-AR|Given ID
16066023|NCT02411786|Biological|gm-csf|Given ID
16066024|NCT02411773|Drug|Sodium Bicarbonate|Sodium bicarbonate tablet is 650 mg for one tablet. Oral sodium bicarbonate will be given out as 1300mg-2600mg (2-4 pills) prior to each exercise or stretching session. Serum bicarbonate measurements will be monitored throughout the study (at 2 weeks, then every 2-4 weeks thereafter), and bicarbonate dosages will be adjusted to avoid metabolic alkalosis (serum HCO3 > 30).
16066025|NCT02411773|Drug|Placebo|2-4 placebo pills will be given out prior to each exercise or stretching session
16066026|NCT02411773|Other|Exercise Training|Exercise training consists of riding a stationary bicycle for 20-45 minutes, 3 times per week, supervised by trained exercise specialists, for 6-12 weeks. The exercise program will follow the guidelines provided by the American College of Sports Medicine (ACSM) for optimizing cardiovascular fitness. Exercise intensity will begin at low levels (50 percent of resting heart rate) and increase to no greater than 80 percent of resting heart rate. Exercise time will progress, depending on subject's progress, from 20 minutes per session at first, to a maximum of 45 minutes. Trained staff members will give instructions throughout each exercise session. Before beginning each exercise session, subjects will be instructed on a warm-up focusing on preparing the legs for activity.
16066027|NCT02411773|Other|Stretching|Stretching exercise will consist of muscle stretching and toning for 20-45 minutes, 3 times per week, supervised by trained exercise specialists, for 6-12 weeks. Trained staff members will guide subjects with the stretching exercises, and activities are designed to increase flexibility and range of motion. Before beginning each stretching exercise session, subjects will be instructed to warm-up.
16066028|NCT02411760|Procedure|3 Tesla Magnetic Resonance Imaging|Assessment of the performance of DWI/ADC measurements alone, and as an adjunct to dynamic contrast enhanced (DCE) MRI in diagnosing/characterizing breast cancer.
16066029|NCT02411747|Behavioral|Testing|
16066030|NCT02411747|Behavioral|Directed self-regulated simulation training|
16066031|NCT02411734|Behavioral|Rehabilitation|Rehabilitation after hospitalization
16066060|NCT02411500|Drug|TRV734|Subjects will be randomized to receive the oral TRV734 treatments on Days 1, 3, 5 and 7 in an open-label, 4-period, cross-over fashion. Days 2, 4, 6 and 8 are designated as washout days.
16066032|NCT02411721|Behavioral|Animal Assisted Intervention|"Initial conversation between dog handler and child. The purpose hereof is to let the child express any fear he experiences towards the examination. The presence of the dog allows the child to project his emotions on the dog and to speak more freely about his anxiety.
~The dog handler informs the child on the various stages of the procedure. For this a booklet has been prepared in which a dog is the patient undergoing an MRI-scan. The child can identify with the dog in the story, and at the same time feel comforted by the dog present.
~Procession of emotions. The child will play freely with the dog. The purpose hereof is to create a soothing atmosphere. In stroking the soft, friendly animal the child may feel more relaxed and therefore less anxious towards the examination."
16066033|NCT02411708|Drug|SANGUINATE|Single two-hour infusion of SANGUINATE
16066034|NCT02411708|Drug|Placebo|Single two-hour infusion of placebo
16066035|NCT02411695|Drug|Brexpiprazole (OPC-34712)|Subjects who are deemed eligible for the trial will be assigned to a dosing cohort and will enter a Dose Titration Phase during which they will receive a starting dose of brexpiprazole for 2 to 10 days based on their assigned titration schedule. The Dose Titration Phase may be extended up to a maximum of 14 days, based on the observed safety and tolerability profile of the previous cohort's Dose Titration Phase. Following the Dose Titration Phase, subjects will enter the Fixed Dose Phase and will be administered the assigned dose for that cohort for 14 days.
16066036|NCT02411682|Other|Breakfast eating (YesB)|On YesB day the patients will eat Breakfast at 8:00, Lunch at 13:30 and Dinner at 19:00
16066037|NCT02411682|Other|Breakfast skipping (NoB)|On NoB day the patients will fast until lunch, then will eat Lunch at 13:30 and Dinner at 19:00
16066038|NCT02411669|Other|Operational patient centered care tools|"The FORAP (Fédération des Organismes Régionaux et territoriaux pour l'Amélioration des Pratiques et des organisations) and the la HAS (High Authority of Health) have developed and validated five tools promoting patient centered care at hospital.
~They can be implemented one by one or in association according to hospital situation. Hospitals should identify the association of tools fitting the most to their objectives and the actions already done."
16066039|NCT02411656|Other|Laboratory Biomarker Analysis|Correlative studies
16066040|NCT02411656|Biological|Pembrolizumab|Given IV
16066041|NCT02411643|Drug|topical calcipotriene 0.005% ointment|Affected area will be treated twice daily for 3 months
16066042|NCT02411630|Drug|Emtricitabine/tenofovir disoproxil|"ATN 123 participants will not be administered Emtricitabine /Tenofovir disoproxil fumarate (Truvada®) as part of the ATN 123 study, but as part of the parent studies, ATN 110 or ATN 113. In order to be eligible for ATN 123, all participants must be co-enrolled in ATN 110 or ATN 113.
~The only intervention for ATN 123 is the administration of the Interactive Questionnaire System (iQS), which is a new method to collect data on adherence. It will be utilized to collect adherence data across a variety of devices (i.e., computer/laptop, smartphone, tablet, etc.). Accuracy of this method will be determined; preference for this mode of data collection compared to other methods for adherence reporting used in the parent studies will be assessed."
16066043|NCT02411617|Device|Drain|Post modified radical mastectomy with either one or two drains Intervention is use of single or double drain
16066044|NCT02411604|Drug|Tacrolimus|Open label, multi-center, expanded access study for renal transplant patients with once daily Envarsus XR.
16066045|NCT02411591|Drug|Necitumumab|Administered IV.
16066046|NCT02411591|Drug|Abemaciclib|Administered orally.
16066047|NCT02411578|Drug|G-Pen Mini™ (glucagon injection)|"1st BG check, 1st treatment
~BG is 50-69 mg/dl, treatment is 150 µg of glucagon
~BG is 40-49 mg/dl, treatment is 300 µg of glucagon
~15 min later, 2nd BG check, 2nd treatment
~BG is 60-69 mg/dl, no treatment
~BG is 50-59 mg/dl, treatment is 150 µg of glucagon
~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
~30 minutes later, 3rd BG check, 3rd treatment
~BG is >=70, no treatment
~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
~(150 µg of glucagon per syringe)"
16066048|NCT02411578|Other|Glucose Tablets|"1st BG check, 1st treatment
~BG is 50-69 mg/dl, treatment is 15 grams of carbohydrates
~BG is 40-49 mg/dl, treatment is 30 grams of carbohydrates
~15 min later, 2nd BG check, 2nd treatment
~BG is 60-69 mg/dl, no treatment
~BG is 50-59 mg/dl, treatment is 15 grams of carbohydrates
~BG is <50 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
~30 minutes later, 3rd BG check, 3rd treatment
~BG is >=70, no treatment
~BG is <70 mg/dl, treatment is participant's preferred oral carbohydrate and not mini-dose glucagon
~(5 grams of fast-acting carbohydrates (D-Glucose) per tablet)"
16066049|NCT02411565|Drug|Fermented Wheat Germ Extract (FWGE)|5.53 grams of FWGE combined with natural orange flavor and stevia Reb-A sweetener to create an instant drink mix, dissolved in 150 mL of water, orally once-daily, for 2 to 4 weeks.
16066050|NCT02411565|Drug|Placebo|Dried and pulverized, white and black rice, 5.53 grams, combined with natural orange flavor and stevia Reb-A sweetener, to create an instant drink mix, dissolved in 150 mL of water, orally once-daily, for 2 to 4 weeks.
16066051|NCT02411565|Other|Standard of Care: Planned Surgery|Participants will undergo their planned surgery during the 2nd to 4th week after entry into the study. However, if there are delays, patients can continue to take drug/placebo for a time period no greater than 2 months. If surgery has not occurred after this 2-month period, the patient will be removed from the study. Participants will take the study drug up until the day prior to surgery. The minimum amount of time on study drug is 2 weeks. A separate consent form will be obtained for the surgical procedure.
16066052|NCT02411565|Other|Quality of Life (QoL) Surveys: FACT-O|Quality of life questionnaire (FACT-O) at the time of enrollment, then weekly and the day of surgery.
16066053|NCT02411552|Behavioral|physical activity|4 strategies are: (1) increased activity time during physical education class, (2) active recess, (3) opportunities for activity before and after school, and (4) active classroom breaks
16066054|NCT02411539|Biological|VRC01|40 mg/kg of VRC01 administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
16066055|NCT02411539|Biological|Placebo|Normal saline administered as an intravenous infusion over about 30 to 60 minutes using a volumetric pump
16066056|NCT02411526|Drug|ZX003 (Risperidone-SABER®)|ZX003 administered as a SC injection
16066057|NCT02411526|Drug|Risperdal Consta|Risperdal Consta administered as a IM injection
16066058|NCT02411526|Drug|Oral Risperidone|Oral Risperidone given to ensure adequate therapeutic plasma concentrations from Risperdal Consta
16066059|NCT02411513|Device|CEFALY|
16066066|NCT02411435|Drug|CAB|CAB 30 mg as 1 tablet will be administered orally with 240 mL of water in the fasted state.
16066067|NCT02411435|Drug|RIF|RIF 600 mg as 2 capsules of 300 mg will be administered orally with 240 mL of water in the fasted state.
16066068|NCT02411422|Device|Conventional endotracheal tube|Conventional endotracheal tube
16066069|NCT02411422|Device|Reinforced endotracheal tube|Reinforced endotracheal tube
16066070|NCT02411409|Behavioral|HealtheRx|The HealtheRx is a prescription for community self-care resources. It includes a printed list of self-care resources provided to the patient at an ambulatory visit and tailored based on data from the electronic medical record.
16066071|NCT02411383|Device|NeuRx Diaphragm Pacing System|NeuRx Diaphragm Pacing System electrodes are placed in the diaphragm during lung transplant surgery. The diaphragm will be continually paced until the patient is free from the ventilator or the patient is discharged from the ICU whichever. Diaphragm measurements are taken daily to assess tolerability and pacing success.
16066072|NCT02411370|Behavioral|phonetic tests|
16066073|NCT02411357|Behavioral|Treatment as usual|General information about contraceptive options and referral to contraceptive service providers
16066074|NCT02411357|Behavioral|WHO contraception protocol|World Health Organization's contraception protocol
16066075|NCT02411357|Behavioral|Incentives|Financial incentives contingent on follow-up visit attendance
16066076|NCT02411344|Drug|Pertuzumab|"Pertuzumab 840 mg loading dose iv on day one, followed by 420 mg iv every 3 weeks for 5 cycles
~Trastuzumab 8 mg/kg loading dose iv on day 2, followed by 6 mg/kg iv on day 2 of each subsequent 3 weekly cycle
~Letrozole 2.5 mg daily p.o. for five 21-day cycles (to be continued until surgery)."
16066077|NCT02411331|Drug|Ethanol 40% + Enoxaparine 400UI/ml|
16066078|NCT02411331|Drug|Vancomycine 5 mg/ml + Héparine 2500UI/ml|
16066079|NCT02411318|Behavioral|Exercise|Participants will ride a stationary bike and maintain their target heart rate (according to the American Heart Association guidelines) for 30 minutes.
16066080|NCT02411318|Drug|ProLab 200mg caffeine capsule|Participants will swallow one ProLab caffeine 200mg tablet.
16066081|NCT02411318|Other|Ethanol ingestion|Participants will consume a dose of 80 proof alcohol according to their body weight to reach a breath alcohol concentration of 0.05.
16066082|NCT02411318|Drug|Glucose Tolerance Drink|Participants will consume 100 grams of glucose
16066083|NCT02411292|Drug|Enoxaparin|Enrolled patients will receive real-time monitoring of peak and trough steady state anti-Xa levels. Out-of-range patients will receive real time dose adjustment of Enoxaparin using a clinical protocol developed with our inpatient pharmacists.
16066084|NCT02411279|Other|Equiped group with telemedicine systems|
16066085|NCT02411266|Other|ischemic conditioning group|application of a blood pressure cuff around a leg and inflating the cuff to 200mmHg to induce limb ischemia for 10min followed by 5min reperfusion. this will be done for 3 cycles every 24-48hours during the first 14 days after subarachnoid hemorrhage
16066086|NCT02411253|Drug|rhIL-2|Subcutaneous injections of IL2 according to regimen A Subcutaneous injections of IL2 according to regimen B
16066087|NCT02411253|Drug|Placebo|Subcutaneous injections of Placebo according to regimen A Subcutaneous injections of Placebo according to regimen B
16066088|NCT02411240|Device|Air filtering|The air filter will be placed in the living room of the elderly people. The efficiency of this device has been tested and a drop of ultrafine particles of more then 70 % is achieved.
16066089|NCT02411227|Behavioral|VR Driving|Baseline: Tactical A3 scenario, composite score Post-Assessment: Tactical A4 scenario composite score
16066090|NCT02411214|Other|survey|questionnaire survey sent by regular mail for 3 groups
16066091|NCT02411201|Drug|DOTAREM|Single intravenous injection of 0.1 mmol/kg body weight
16066092|NCT02411188|Behavioral|The STEP Program|Intervention: The 12-week STEP Program will include: initial individual consult/goal setting; weekly 90 minute information/interactive sessions; individualized patient centred care; journaling
16066093|NCT02411175|Other|Individualised Homeopathic Remedy|20% ethanol will be medicated with the Individualised Homeopathic Remedy in the potency determined by the researcher in accordance with the laws that govern individualised homeopathic prescribing. The medicated 20% ethanol will be administered as drops.
16066094|NCT02411175|Drug|20% ethanol|
16066095|NCT02411162|Drug|Combination therapy GSK2894512 Cream A + GSK2894512 Cream B|GSK2894512 Cream A, 1% (10mg/g) will be topically applied daily for 7 days as a thin layer onto an area of the volar region of one forearm (up to 1.5% body surface area) and GSK2894512 Cream B, 1% (10mg/g), will be topically applied daily for 7 days to the opposite forearm from Cream A, onto an area of the volar region of one forearm (up to 1.5% body surface area). Both the creams will be weighed to deliver approximately 3mg drug per 1cm^2 of skin.
16066096|NCT02411162|Drug|Combination therapy Vehicle Cream A + Vehicle Cream B|Vehicle creams A and B will be supplied in individual tubes. Both the creams will be topically applied on Day 1 only to a separate area (at least 1.3 cm from study drug) of the forearm from where drug is applied.
16066097|NCT02411149|Drug|Adductor Canal Block|Use of ropivacaine 0.5% with 1:400,000 epinephrine in the adductor canal along with a spinal anesthesia of 3ml 0.5% preservative-free bupivacaine.
16066098|NCT02411149|Drug|Adductor Canal Block with Morphine|Use of ropivacaine 0.5% with 1:400,000 epinephrine in the adductor canal along with a spinal anesthesia of 3ml 0.5% preservative-free bupivacaine and 100mcg of intrathecal morphine (0.1ml of intrathecal morphine 1mg/ml)
16066099|NCT02411149|Drug|Local Infiltration|30 ml normal saline in the adductor canal along with a spinal anesthesia of 3ml 0.5% preservative-free bupivacaine, in addition to the local infiltration.
16066100|NCT02411136|Drug|AMG 623|Multiple doses of AMG 623 administered as subcutaneous and intravenous doses
16066101|NCT02411136|Drug|Placebo|Multiple doses of AMG 623 administered as subcutaneous and intravenous doses
16066102|NCT02411123|Genetic|IDgenetix Neuropsychiatric Test Panel|The IDgenetix Neuropsychiatric Test Panel is used to make recommendations on the medication therapy that might be impacted by the genetic background of the patient.
16066103|NCT02411110|Combination Product|LiRIS®|LiRIS® is a drug-device combination product which is placed in the bladder during cystoscopy and remains in the bladder, gradually releasing lidocaine until removed from the bladder via cystoscopy.
16066137|NCT02410876|Procedure|Urodynamic study|Assessment of bladder function through intravesical and intrabdominal pressure measurements according to International Continence Society standards.
16066104|NCT02411110|Combination Product|LiRIS Placebo|LiRIS placebo is a drug-device combination product, matching the LiRIS® which is placed in the bladder during cystoscopy, remains in the bladder until removed from the bladder via cystoscopy.
16066105|NCT02411097|Procedure|femoral nerve block|use the nerve stimulator,the femoral nerve block will be administered before or after the surgery
16066106|NCT02411084|Biological|Begelomab|BEGEDINA® (Begelomab) is a murine immunoglobulin G (IgG) 2b monoclonal antibody against CD26 (dipeptidyl peptidase-4; DPP4) and is produced by biotechnological means.
16066107|NCT02411084|Biological|Conventional Second-line Treatment|"There are no approved second-line treatments for aGvHD and due to the life-threatening nature of the disease it was agreed with the FDA and EMA that BEGEDINA® would be compared with best conventional second-line treatments which will be chosen by each center, based on the clinical conditions of the individual subject and according to the standard practice at the study center and which may vary between centers. Treatments are generally biological products and could include anti-thymocyte globulin, monoclonal antibodies, such as anti-CD147, basiliximab, daclizumab and alemtuzumab; mycophenolate mofetil; anti-TNF-alpha; pentostatin; dinileukin diftitox; N-acetyl-cysteine; sirolimus; and visulizumab."
16066108|NCT02411058|Behavioral|Uninformed|Users will receive 20x their usual incentives for two weeks, but will either receive no emails informing them about the incentive program.
16066109|NCT02411058|Behavioral|Informed|Users will receive 20x their usual incentives for two weeks, and they will receive emails informing them about the incentives (one announcement before the incentives begin, and one email every two days reminding them about the overall incentive program). These emails will contain information about the incentives and the purpose of the incentives. The reminder emails sent every two days, however, will include more information about the overall program incentives to maximize the number of participants who learn about the incentive program at some point.
16066110|NCT02411045|Behavioral|Take and send a selfie|Direction to take and send a selfie.
16066111|NCT02411045|Behavioral|Workout gears|Direction to wear workout gears.
16066112|NCT02411045|Behavioral|Exercise|Direction to complete a 30 minute workout.
16066113|NCT02411032|Behavioral|Reminder|Customer gets mailing that reminds them to take their medication.
16066114|NCT02411032|Behavioral|Fresh start|Customers receive a mailing around a fresh start event: New Year's or birthday
16066115|NCT02411032|Behavioral|Fresh start framing|The fresh start event will be highlighted in the mailings.
16066116|NCT02411019|Biological|GX-188E|In phase II study, 72 patients were assigned to two dose groups (1mg and 4mg) and were administered three times with GX-188E by electroporation during an entire period of study. After the final administration, the follow-up will be conducted to investigate safety and efficacy aspects.
16066117|NCT02411006|Behavioral|Prediction mailing|Ask people to predict their upcoming medication adherence
16066118|NCT02411006|Behavioral|Commitment mailing|Ask people to commit to their upcoming medication adherence
16066119|NCT02411006|Behavioral|Reminder|Remind people to take their medicine
16066120|NCT02411006|Behavioral|Anonymity|Keep patient predictions and commitment anonymous
16066121|NCT02411006|Behavioral|Identification|Ask patients to report their predictions and commitments
16066122|NCT02410993|Procedure|CABG surgery|
16066123|NCT02410980|Drug|Tretinoin cream 0.1%|Assessment of the skin change
16066124|NCT02410967|Behavioral|Attention Bias Modification|At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders.
16066125|NCT02410967|Behavioral|Placebo Attention Task|At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability.
16066126|NCT02410954|Device|NeuroConn Direct Current stimulator Multiple Channel -4|(tDCS) will be administered with a multichannel tDCS device that can be programmed so that the operator doesn't know the combination of electrodes being used for stimulation, and, thereby allow double-blinding. The active tDCS electrode configuration to be used will be determined with the 3 round iterative procedure described above; based on electric field modeling and personalized electrical dose titration to find the lowest dose that is well-tolerated and engages the target in terms of inhibiting the AOT pupillary response.
16066127|NCT02410941|Behavioral|Clinical decision support|Establish evidence-based standardized clinical pathways implemented by local communities of practice focused on imaging utilization in ED settings as models of participatory research and integrated knowledge translation.
16066128|NCT02410928|Device|direct laringoscopy|the vocal cords will be visualized after extubation with direct laringoscopy
16066129|NCT02410928|Device|fiberoptic nasal laringoscopy|the vocal cords will be visualized after extubation with fiberoptic nasal laringoscopy
16066130|NCT02410928|Device|ultrasonograph|the vocal cords will be visualized after extubation with fiberoptic ultrasonography
16066131|NCT02410915|Device|Hybrid Assistive Limb (HAL); gait training|Training with HAL is performed in 1 session per day, 4 days per week during 4 weeks. Time for each session is individualised but does not exceed 60 minutes/session (effective time). Training with HAL is performed in combination with body-weight support system and on a treadmill. The training program is performed by 2 physiotherapists, who have been trained in the HAL method.
16066132|NCT02410915|Other|Control Group; Conventional gait training|Conventional gait training is individualized and performed according to current practice (approximately 30-60 minutes/session, 5 days a week) and may include standing, weight shifting, stepping, over ground walking with assistance and/or assistant devices as well as the use of a treadmill and body weight support. Conventional gait training is offered to both study groups.
16066133|NCT02410902|Drug|CM-AT|Single unit dose powder of active substance (CM-AT) administered 3 times per day for 90 days
16066134|NCT02410902|Drug|PLACEBO|Single unit dose powder of non-active substance administered 3 times per day for 90 days
16066135|NCT02410889|Other|EEG-fMRI scanning|Patients undergo EEG-fMRI scanning
16066136|NCT02410876|Procedure|Bladder biopsy|Small biopsy of the bladder is taken with cold-cup tongs.
16066141|NCT02410837|Procedure|Electromagnetic Navigation Bronchoscopy|
16066142|NCT02410824|Device|stenfilcon A toric lens|toric contact lens
16066143|NCT02410824|Device|etafilcon A toric lens|toric contact lens
16066144|NCT02410811|Other|Cardiac magnetic resonance imaging (CMR)|CMR is obtained on all participants in all arms/groups
16066145|NCT02410798|Device|TransLoc electrode|Patients will have 2 electrodes placed in either side of the diaphragm (total 4 electrodes) during their primary surgery.
16066146|NCT02410785|Device|Polyglucosamine|ß-1,4 polymer of D-glucosamine and N-acetyl-D-glucosamine from the shells of crustaceans
16066147|NCT02410785|Other|Placebo|Placebo tablet
16066148|NCT02410772|Drug|rifapentine|Regimen 2: Rifapentine is substituted for rifampin as the basis of 4-month treatment
16066149|NCT02410772|Drug|rifapentine and moxifloxacin|Regimen 3: In addition to the single substitution described for regimen 2, a second substitution is added, of moxifloxacin for ethambutol.
16066150|NCT02410772|Drug|control|standard six-month treatment
16066151|NCT02410759|Drug|Carbetocin|100 women with atonic PPH will receive Carbetocin 100 µgm IM
16066152|NCT02410759|Drug|Ergometrine|100 women with atonic PPH will receive Ergometrine 0.5 µgm IM
16066153|NCT02410746|Other|targeted chirocaine pec block|10ml 0.25% chirocaine in a specifically targeted in a nerve block
16066154|NCT02410746|Other|standard chirocaine infiltration|10ml 0.25% chirocaine is infiltrated into breast pocket in a non targeted fashion
16066155|NCT02410746|Other|standard post-operative analgesia|A dose of morphine 0.1mg/kg will be given intra-operatively. Thereafter morphine 0.1mg/kg will be given for breakthrough pain. Patients will be prescribed regular paracetamol and ibuprofen.
16066156|NCT02410733|Biological|Lipo-MERIT|vaccination
16066157|NCT02410720|Other|Instruction leaflet|Patients will receive the Picoprep solution with an instruction leaflet of how to use it and the dietary modifications needed
16066158|NCT02410720|Other|Mobile App|Patients will receive Picoprep solution with an instruction leaflet + Picoprep Mobile App which will be downloaded to their smartphones that has the same information plus a reminder utility
16066159|NCT02410720|Other|Explanation of paper and application instructions|The research fellow will explain instructions to patients
16066160|NCT02410720|Other|Picoprep solution|
16066161|NCT02410707|Drug|Nitrous Oxide arm|Patients undergoing procedural sedation with propofol will undergo an initial medical assessment including the history, physical examination, and vital signs. The patients will then receive Nitrous Oxide gas via a gas mixer device before receiving propofol. The device will mix and deliver nitrous oxide and oxygen in a 1:1 ratio, at a fixed concentration of 50%/50%. The on demand valve requires patient inspiration to trigger dosing.
16066162|NCT02410707|Drug|Propofol|The loading dose of propofol will be administered immediately after nitrous oxide discontinuation. All sedations in this trial will use propofol 1.0 mg/Kg initial dose, with 0.5 mg/Kg doses titrated to deep sedation. Once the patient is deeply sedated, the procedure will begin.
16066163|NCT02410707|Drug|Oxygen|If pulse oximetry declines to less than 92%, subject will be placed on nasal cannula with administration of 2 liter flow of oxygen and titrated in increments of 1 L flow to maintain pulse oximetry greater than 92%
16066164|NCT02410694|Drug|Ixazomib|
16066165|NCT02410694|Drug|Thalidomide|
16066166|NCT02410694|Drug|Dexamethasone|
16066167|NCT02410681|Device|Electromyographic recording of temporalis muscle activity during sleep|"Electromyographic recording of temporalis muscle activity during sleep. In total, 9 sleep recordings will be done at the home setting of each participant.
~3 recordings after the baseline visit
~3 recordings 6 weeks after the baseline visit
~3 recordings one year after the baseline visit"
16066168|NCT02410681|Radiation|Vertical bitewing radiograph|An intraoral vertical bitewing radiograph will be performed with the assistance of individually modified plate positioning devices at each visit (in total 8 visits during the 2-year follow-up period).
16066169|NCT02410681|Other|Collection of biofilm sample|"Collection of peri-implant intrasulcular biofilm sample for DNA analysis of the biofilm composition. In total, samples will be collected three times:
~At the baseline visit
~Three months after the baseline visit
~One year after the baseline visit"
16066170|NCT02410668|Dietary Supplement|flaxseed|
16066171|NCT02410668|Dietary Supplement|Placebo|
16066172|NCT02410668|Behavioral|Exercise recommendation|
16066173|NCT02410655|Drug|Oxytocin|500 mL bag of oxytocin (30 IU / 500 mL) to be connected to the IV, and controlled at the obstetricians request. Up to two, 50 mL rapid infusion boluses to be given after delivery of anterior shoulder. Upon completing the bolus(es) flow rate should be continued at 100 mL / hour. This should total no more than 4.5 hours.
16066174|NCT02410655|Drug|Oxytocin|A total of two 1000 mL bags of oxytocin (20 IU/ 1000 mL) are to be connected to the IV sequentially, and controlled at the obstetricians request, are each to be administered over 8 hours after delivery of anterior shoulder in vaginal delivery. This will total 16 hours of oxytocin infusion.
16066175|NCT02410642|Procedure|cardiopulmonary bypass|Routine use of cardiopulmonary bypass as needed during cardiac surgery
16066176|NCT02410629|Device|Music Glove|Participants will exercise at home using the music glove for 3 times a week for 3 weeks with a minimal of 3 hours per week.
16066177|NCT02410629|Other|Conventional Hand Exercise Program|Participants will exercise at home using the hand exercise program designed by an occupational therapist for 3 times a week for 3 weeks with a minimal of 3 hours per week.
16066178|NCT02410616|Behavioral|Blended CBT|Internet based blended CBT depression treatment combines individual face-to-face cognitive behavioural therapy (CBT) with CBT delivered through an Internet based treatment platform with mobile phone components. The core components of the CBT treatment are: (1) psychoeducation, (2) behavioural activation, (3) cognitive restructuring, and (4) relapse prevention.
16066179|NCT02410616|Behavioral|Treatment as usual|Treatment as usual (TAU) is defined as the routine care that subjects receive when they are diagnosed with depression in the secondary care system. The investigators will not interfere with treatment as usual but they will monitor carefully which health care services are utilized by usual care patients using patient records and through self-report.
16066180|NCT02410590|Drug|Rocuronium|
16066181|NCT02410590|Drug|Sugammadex|
16066182|NCT02410590|Drug|Cisatracurium|
16066183|NCT02410590|Drug|Neostigmine/Atropine|
16066184|NCT02410590|Drug|Succinylcholine|
16066185|NCT02410577|Drug|89Zr-J591|The intervention is the administration of an injection of 18-19mg of unchelated J591 to reach the total administered dose of antibody followed by 5 mCi (+/- 10%) of 89Zr-J591 (1 to 2 mg) . After administration of the experimental tracer, the patient will undergo a Brain PET/CT scan 24 hours, 48 hours post injection and 3-8 days. The 48 hour scan is strongly suggested, but optional.
16066186|NCT02410577|Device|PET/CT Scan|
16066187|NCT02410577|Device|MRI|
16066188|NCT02410577|Other|Blood draw|Bloods samples will be drawn immediately before and approximately 30 minutes after 89Zr-J591 injection.
16066189|NCT02410564|Behavioral|cognitive behavioral therapy for insomnia (CBTI)|SHUTi program is made up of six, weekly treatment Cores modeled after weekly facetoface(CBTI). Each Core begins by providing a rationale for learning the material, explains main content, homework page with suggestions for improving sleep, and a summarized review of main points. The main content each Core addresses myths about sleep, indepth information about topics, vignettes, and quizzes to evaluate users learning in an interactive. As well as being interactive, SHUTi allows for personalization.Modifications are made to sleep recommendations based in sleep diary data and individually set treatment goals. The cores include Overview, Sleep Behavior Core, Sleep Behavior Core 2, Sleep Education Core, Sleep Thoughts Core, and Problem Prevention Core. Each Core takes approximately 45 to 60 minutes to complete. Cores are presented one at a time; next Core becomes available to users a week after they complete one Core.
16066190|NCT02410564|Behavioral|Waitlist control condition|Phone calls with control participants, no advice regarding sleep will be given and if participants ask, they will be informed that such advice can be provided in a few weeks if they choose to crossover to the treatment condition at the end of the study.
16066191|NCT02410551|Drug|Pacritinib|200 mg by mouth twice a day for 60 days.
16066192|NCT02410551|Drug|Busulfan|Busulfan AUC of 4000 microMol-min per day providing that pharmacokinetic can be done, otherwise Busulfan dose given as a fixed dose of 100 mg/m2 daily for four days.
16066193|NCT02410551|Behavioral|Questionnaires|Questionnaires completed at baseline, 1, 3, 6, and 12 months after transplant.
16066194|NCT02410551|Behavioral|Phone Calls|Phone calls made by study staff to participant on second and third week of each month.
16066195|NCT02410551|Procedure|Allogeneic Stem Cell Transplantation|Allogeneic stem cell transplantation (Allo TP) 60 days after starting Pacritinib but not more than 180 days.
16066196|NCT02410551|Drug|Fludarabine|Fludarabine taken along with Busulfan as per standard of care as preparative regimen for allogeneic stem cell transplantation (Allo TP).
16066197|NCT02410538|Other|"list of FAQ"|
16066198|NCT02410525|Drug|[11C]PF-06427878|Single administration via intravenous infusion of 20 ug [11C]PF-06427878 on Day 1 of all 3 Periods
16066199|NCT02410525|Drug|PF-06427878 10 mg|Single oral administration of 10 mg PF-06427878 on Day 1 of Period 2 or 3, at approximately 2.5 hours prior to [11C]PF-06427878 administration
16066200|NCT02410525|Drug|PF-06427878 600 mg|Single oral administration of 600 mg PF-06427878 on Day 1 of Period 2 or 3, at approximately 2.5 hours prior to [11C]PF-06427878 administration
16066201|NCT02410512|Drug|Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 [PD-L1] antibody|Atezolizumab will be administered intravenously.
16066202|NCT02410512|Drug|MOXR0916, a humanized agonist anti-OX40 monoclonal antibody|MOXR0916 will be administered intravenously.
16066203|NCT02410499|Drug|MLN1202 Placebo|MLN1202 placebo-matching solution for SC injection
16066204|NCT02410499|Drug|MLN1202|MLN1202 solution for SC injection
16066205|NCT02410473|Other|Discarded blood samples|Will utilize the discarded blood from routine clinical blood samples to evaluate the input of the newer technologies that helped for the diagnostic of coagulopathy.
16066206|NCT02410473|Other|Discarded Urine Sample|Will utilized the discarded urine samples from the routinely placed Foley catheter to measure the indices of oxidative stress.
16066207|NCT02410460|Drug|clonidine|
16066208|NCT02410460|Drug|glycopyrrolate|
16066209|NCT02410460|Drug|propofol|
16066210|NCT02410460|Drug|ketamine|
16066211|NCT02410460|Drug|marcaine|
16066212|NCT02410460|Drug|scopolamine|
16066213|NCT02410460|Drug|midazolam|
16066214|NCT02410460|Device|ondansetron|
16066215|NCT02410460|Drug|metoclopramide|
16066216|NCT02410460|Drug|glycopyrrolate|
16066217|NCT02410460|Drug|lidocaine|
16066218|NCT02410460|Drug|famotidine|
16066219|NCT02410460|Drug|desflurane|
16066220|NCT02410460|Drug|sevoflurane|
16066221|NCT02410447|Device|Defocused shock wave therapy (DUOLITH® SD1)|
16066222|NCT02410434|Other|LGBT Stigma Reduction Intervention|Participants will complete a pre-test, followed by a performance ethnography where they will watch theatre performances that illustrate stigma experienced by LGBT persons in Swaziland and Lesotho. They will have the opportunity to participate in these theatre performances to demonstrate reduced stigma and increased acceptance of LGBT persons. They will then complete a post-test, followed by a 6 week follow up survey.
16066223|NCT02410421|Procedure|Functional magnetic resonance imaging used to individualize rTMS protocol using robotic coil positioning|
16066224|NCT02410408|Device|Apps Root Cause Analysis or patient safety ISO certification|Apps for conducting RCA or PSC
16066225|NCT02410408|Other|information package|Information on PSC and RCA
16066226|NCT02410395|Procedure|Conventional|Two-layer technique with the first layer performed as an un-locked, continuous suture without inclusion of the endometrium and the second layer performed as an un-locked, continuous suture with the stitches placed superficially, horizontally along the first layer.
16066227|NCT02410395|Procedure|Modified|The modified mattress suture is performed as a single-suture, double-layer technique with limited inclusion of the myometrium and broad inclusion of the serosal surface and myometrium, interchangeably
16066228|NCT02410382|Drug|Dexamethasone|oral dexamethasone 4 mg bid for 14 days
16066229|NCT02410382|Drug|Placebo|oral placebo
16066230|NCT02410369|Drug|S-588410|Following randomization, subjects with HLA-A*2402 in the investigational arm will receive the subcutaneous administration of S-588410.
16066231|NCT02410369|Drug|Placebo|Following randomization, subjects with HLA-A*2402 in the investigational arm will receive the subcutaneous administration of Placebo.
16066417|NCT02409004|Drug|Rifampin|Capsule 2x3oo mg Oral
16066232|NCT02410356|Drug|TV-1106|The volume necessary to provide the required weekly dose will be calculated by the investigator; dose will be adjusted for IGF-I in the normal range.
16066233|NCT02410356|Drug|dGH|The dose levels of dGH will be the same as the stable rhGH dose taken prior to the study.
16066234|NCT02410343|Drug|TV-1106|A starting dose of 5.0 mg was expected to be appropriate for most patients because the daily recommended starting dose of recombinant human growth hormone (rhGH) treatments (e.g. somatropin) is 0.2 mg/day, and the conversion factor was 28. Dosage could be titrated by an unblinded central reader on weeks 4, 8, 12 and 16 until the participant's insulin-like growth factor 1 (IGF-1) standard deviation score (SDS) was within the range of -0.5 to +1.5.
16066235|NCT02410343|Drug|Placebo|Placebo treatment was administered in a blinded fashion and titrated on weeks 4, 8, 12 and 16 to mimic the active treatment.
16066236|NCT02410330|Procedure|Therapeutic ultrasound with 20 usec|A custom designed high mechanical index (MI) impulses at 4-20 usec and >1.0 mechanical index designed for the 1.7 MHz S5-1 transducer
16066237|NCT02410330|Procedure|Repeated diagnostic high mechanical index|Repeated diagnostic high mechanical index impulses (all <2 usec pulse duration; MI=1.0) whenever very low mechanical index perfusion imaging detected microbubbles within the microvasculature
16066238|NCT02410317|Drug|Ropivacaine|
16066239|NCT02410317|Drug|Morphine|
16066240|NCT02410304|Device|Xrays|Clinical evaluation
16066241|NCT02410304|Device|Ultrasound (B mode )|
16066242|NCT02410304|Device|Ultrasound (D mode)|
16066243|NCT02410291|Other|Educational video|Patients in the control group will receive standard patient education Patients in the experimental group will receive standard education and an educational video
16066244|NCT02410278|Drug|dimethyl fumarate|Starting dose of 120 mg twice daily orally After 7 days, maintenance dose of 240 mg twice daily orally
16066245|NCT02410278|Drug|montelukast|As described in the treatment arm
16066246|NCT02410278|Drug|Placebo|Matched placebo
16066247|NCT02410265|Behavioral|Lantern: Guided self-help program|"Subject assigned to the Lantern intervention will receive 3-month access to a web-based, CBT-based guided self-help intervention for GAD. In the program, they receive psycho-education about GAD and the management of symptoms of GAD along with access to an e-coach who can monitor their progress in the program and provide feedback and encouragement via messaging and one voice call."
16066248|NCT02410265|Behavioral|Mental Health Online: Self-help program|Subject assigned to the Mental Health Online (MHO) intervention will receive 3-month access to a web-based, CBT-based self-help intervention for GAD. In the program, they receive psycho-education about GAD and the management of symptoms of GAD.
16066249|NCT02410252|Device|iThermonitor|The device is a continuous temperature monitoring tool for home monitoring of temperature. Participants are asked to use this device for two weeks.
16066250|NCT02410239|Biological|Mesenchymal Stem Cells|
16066251|NCT02410226|Procedure|Double-space combined spinal-epidural anesthesia|Epidural space identification in Lumbar 2-3 or 3-4 space using loss of resistance to air technique with 18-gauge Tuohy needle, then threading a 20-gauge multi-orifice epidural catheter 4-5 cm into the epidural space. Spinal anesthesia administration in an appropriate lower intervertebral space with intrathecal bupivacaine 12.5 mg and fentanyl 10 mcg through a 27-gauge spinal needle.
16066252|NCT02410226|Radiation|Preprocedure spinal ultrasound|Lumbar spinal ultrasound using the 2-5 MHz curved probe, performed in both the longitudinal and transverse planes for identification of the appropriate intervertebral spce, estimation of the depth to the epidural space, and noting the proper angle for subsequent needle insertion. Then skin markings relying on the ultrasound procedure are made identifying 2 intervertebral spaces.
16066253|NCT02410226|Radiation|Sham ultrasound procedure|Applying the ultrasound probe on the patient's back while the ultrasound machine is on the freeze position.Then skin markings relying on landmark palpation are made identifying 2 intervertebral spaces.
16066254|NCT02410213|Drug|Ferric Carboxymaltose (FCM)|
16066255|NCT02410200|Drug|dimethyl fumarate|
16066256|NCT02410187|Radiation|SBRT|10 Gy x 3 - 20 Gy x 3 (BED 60Gy-180 Gy) or 8 Gy x 4 - 17 Gy x 4 (BED 58-184 Gy)
16066257|NCT02410187|Drug|systemic therapy (chemotherapy, hormon therapy, target therapy etc)|"Physicians can choose all the options available chemotherapy, hormon therapy, target therapy etc.
~Use of chemotherapy schemes containing potent enhancers of radiation damage (e.g. gemcitabine,adriamycin) are discouraged within the first month after SBRT."
16066258|NCT02410187|Radiation|palliative RT|fraction size of RT = < 3 Gy
16066259|NCT02410174|Radiation|Stereotactic Body Radiotherapy (SBRT)|
16066260|NCT02410161|Dietary Supplement|alpha-linolenic acid-rich supplement|each participant consumed one 1000 mg capsule of flaxseed oil four times per day for 4 weeks, providing a total of 2 g/d of ALA. The capsules used were a commercially available flaxseed oil supplement containing ALA at 56% of total fatty acids (Jamieson, Toronto, ON, Canada). The other main fatty acids present in flaxseed oil include linoleic acid (18%), oleic acid (16%), palmitic and stearic acid (10% combined).
16066261|NCT02410148|Device|Non-invasive ICP measurement (Vittamed 305)|The non-invasive method is based on two-depth TCD technique for simultaneously measuring flow velocities in the intracranial and extracranial segments of the ophthalmic artery (OA).
16066262|NCT02410135|Drug|Mirabegron|25 mg PO per day for four weeks. if tolerated then uptitrated to 50 mg PO per day for the remaining 8 weeks
16066263|NCT02410109|Behavioral|SCRIPT integrated model|Perinatal women will be screened for psychosocial risks at time of home visiting enrollment. Women exhibiting elevated depressive symptoms and/or have a history of clinical depression who are not currently clinically depressed will be referred for depression prevention services. Women experiencing a depressive episode will be referred for group CBT. Women who screen positive for elevated anxiety symptoms, PTSD symptoms, intimate partner violence, or substance abuse will be referred to a mental health or social service agencies. If a client is referred for services, the assessment worker will provide written educational materials about the risk factor that is being addressed through the referral. At the first home visit, the home visitor will discuss these educational materials.
16066264|NCT02410096|Other|Exercise challenge in a cold chamber|Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber.
16066265|NCT02410096|Other|Methacholine challenge|Nebulized metacholine administered at following doses: 0,01mg, 0,1mg, 0,4mg, 0,8mg und 1,6mg
16066463|NCT02408614|Device|Treadmill|
16066266|NCT02410096|Dietary Supplement|Oil supplementation verum|Patients and subjects will take double blind an oil supplementation with middle-chain and polyunsaturated fatty acids for four weeks
16066267|NCT02410096|Dietary Supplement|Oil supplementation placebo|Patients and subjects will take double blind sunflower oil for four weeks
16066268|NCT02410083|Drug|Clopirin 1|
16066269|NCT02410083|Drug|Clopidogrel-Aspirin(co-administration) 1|
16066270|NCT02410083|Drug|Clopirin 2|
16066271|NCT02410083|Drug|Clopidogrel-Aspirin(co-administration) 2|
16066272|NCT02410070|Procedure|Incision|The objective of this report is to compare a minimal invasive approach with the conventional flexor carpi radialis approach for volar plating of distal radial fractures.
16066273|NCT02410057|Dietary Supplement|Protein-reduced α-lactalbumin formula|Protein-reduced formula with levels of α-lactalbumin more similar to breast milk and higher than in whey formula and in standard infant formula
16066274|NCT02410057|Dietary Supplement|Protein-reduced whey formula|Protein-reduced whey formula with higher levels of α-lactalbumin than in standard infant formula
16066275|NCT02410057|Dietary Supplement|Standard infant formula|Standard infant formula
16066276|NCT02410031|Drug|Cyproterone acetate 2mg/ethinylestradiol 35 μg (Diane-35)|Cyproterone acetate 2mg/ethinylestradiol 35 μg
16066277|NCT02410018|Device|OCL 503 (uterine artery embolization)|Transcatheter embolization of the uterine artery(ies) using an embolic agent.
16066278|NCT02410005|Dietary Supplement|Calcitriol|
16066279|NCT02410005|Drug|Losartan|
16066280|NCT02409992|Behavioral|Parent Training plus Emotion Coaching|This intervention will combine a parent management training program called Helping the Noncompliant Child with elements of an Emotion Coaching parenting program.
16066281|NCT02409992|Behavioral|Parent Training only|This intervention will consist of a parent management training program called Helping the Noncompliant Child.
16066282|NCT02409979|Other|Carbon dioxide method|Insufflation with CO2 during insertion and withdrawal phases of colonoscopy.
16066283|NCT02409979|Other|Water Exchange-CO2|Insertion using water exchange, withdrawal using CO2 insufflation.
16066284|NCT02409979|Other|Water Exchange-AI|Insertion using water exchange, withdrawal using air insufflation.
16066285|NCT02409966|Procedure|Quadrant-wise scaling|"Patients underwent quadrant scaling under local anesthesia in four weekly sections. Three experienced trained periodontists carried out debridement procedures of both protocols with manual Gracey and McCall curettes and Hirschfield files.
~Oral hygiene instructions were given for all participants and oral supplies were provided for the duration of the study."
16066286|NCT02409966|Procedure|Full-mouth 24-hour scaling|"Patients underwent full-mouth scaling under local anesthesia in two sections within 24 hours. Three experienced trained periodontists carried out debridement procedures of both protocols with manual Gracey and McCall curettes and Hirschfield files.
~Oral hygiene instructions were given for all participants and oral supplies were provided for the duration of the study."
16066287|NCT02409953|Other|Lying in a bath during 2 hours|
16066288|NCT02409953|Other|Lying in a bed during 2 hours|
16066289|NCT02409940|Biological|Mesenchymal Stem Cells|These Mesenchymal stem cells are derived from bone marrow of either renal transplant patients or their donors depending upon the group of study.
16066290|NCT02409927|Dietary Supplement|MCT oil 10g|10 g of pure MCT oil mixed with skim milk in a standardized breakfast
16066291|NCT02409927|Dietary Supplement|MCT homogenate 10g|10g provided by 10% MCT homogenate mixed with skim milk in a standardized breakfast
16066292|NCT02409927|Dietary Supplement|Control|vehicule (skim milk) with a standardized breakfast
16066293|NCT02409927|Dietary Supplement|MCT oil 20g|20g of pure MCT oil mixed with skim milk in a standardized breakfast
16066294|NCT02409927|Dietary Supplement|MCT homogenate 20g|20g provided by 10% MCT homogenate mixed with skim milk in a standardized breakfast
16066295|NCT02409927|Dietary Supplement|MCT oil 30g|30g of 100% pure MCT oil mixed with skim milk in a standardized breakfast
16066296|NCT02409927|Dietary Supplement|MCT homogenate 30g|30g provided by 10% MCT homogenate mixed with skim milk in a standardized breakfast
16066297|NCT02409901|Behavioral|Exercise Rehabilitation|12 month personalized exercise rehabilitation in addition to standard clinical care
16066298|NCT02409888|Behavioral|Motivational Enhancement Therapy|The motivational enhancement therapy will be delivered according to the Project MATCH manual.
16066299|NCT02409888|Behavioral|Cognitive Behavioral Therapy|The cognitive behavioral therapy will be delivered according to the Project MATCH manual.
16066300|NCT02409888|Other|FC Assessment|FC Assessment study participants are exposed to quarterly assessments across broad domains of functioning.
16066301|NCT02409888|Other|IB Assessment|IB Assessment study participants are exposed to semi-annual alcohol specific assessments
16066302|NCT02409862|Drug|Oxytocin Spray|This group will receive the single dose of 24 IU oxytocin, self-administered intranasally (IN). Prior to administration a saliva sampling will be done. Afterwards, they will participate in the Choices Study during EEG and eye tracking recording.
16066303|NCT02409862|Drug|Placebo Spray|This group will receive the single dose of 24 IU placebo, self-administered intranasally (IN). Prior to administration a saliva sampling will be done. Afterwards, they will participate in the Choices Study during EEG and eye tracking recording.
16066304|NCT02409849|Drug|Octreotide lar|
16066305|NCT02409836|Drug|Marketed Dentifrice|Marketed Dentifrice
16066306|NCT02409836|Drug|Marketed Flavored Dentifrice|Hawaiian Punch Flavored
16066307|NCT02409836|Drug|Marketed Flavored Dentifrice|Bubble Gum Flavored
16066308|NCT02409823|Drug|Atypical Antipsychotics|any atypical antipsychotic
16066309|NCT02409810|Drug|Dexmedetomidine|Prior to the burn dressing changes PCA-DEX patients will receive a bolus of dexmedetomidine (Precedex®) 0.25 mcg/kg administered over 10 minutes by nursing staff, followed by a continuous infusion of Precedex® at 0.4 mcg/kg/hr via a standard infusion pump (LifeCare PCA). Patients will self-medicate as needed for anxiety self-management by self-administering a bolus of Precedex® 0.1 mcg/kg. This dosage is within the FDA-approved package insert parameters. Heart rate, blood pressure and oxygen saturation will be closely monitored by a staff RN already trained to provide care in the procedure room. 1 hour prior to- and after completion of the burn dressing change each day using a 100-mm visual analog scale. Patients will both rate their satisfaction with PCA-DEX for anxiety management after each completion of the burn dressing change.
16066310|NCT02409797|Other|Flexion-Distraction (non-thrust) spinal manipulation|Enrolled participants will receive chiropractic care over a 2-week period. Chiropractic care includes standard therapies for back pain. A doctor of chiropractic determines the therapeutic approach and treatment frequency based upon a participant's clinical presentation. If provided, treatments will include low-velocity (non-thrust) spinal manipulation using the Flexion-Distraction procedure. Recommendations for exercise, lifestyle modifications, or other therapies may also be provided.
16066311|NCT02409784|Dietary Supplement|Pre-KD|Before starting 4 days of 4:1 (lipids:protein/carbohydrates) ketogenic diet
16066312|NCT02409784|Dietary Supplement|Post-KD|After 4 days of 4:1 (lipids:protein/carbohydrates) ketogenic diet
16066313|NCT02409771|Device|PRECIZON Presbyopic|Optical correction of aphakia in adults in whom the crystalline lens has been removed and who desire presbyopia correction.
16066314|NCT02409758|Behavioral|Voice therapy|Voice therapy applied during 6 weeks.
16066315|NCT02409745|Procedure|endometrial scratch|local injury to the endometrium by Pipelle
16066316|NCT02409732|Drug|aminolevulinic acid hydrochloride|
16066317|NCT02409732|Procedure|Photodynamic therapy with blue light|
16066318|NCT02409719|Other|Schedule|Illustrative daily planner to point the day that the exercise was performed
16066319|NCT02409719|Other|Verbal Information and Booklet|Verbal information will be provided in order to explain how the patient should perform physical rehabilitation exercises. Furthermore, an illustrative booklet with representative exercises will be given. Also, an illustrative daily schedule to mark on the exact day in which the exercise was performed
16066320|NCT02409693|Procedure|Myringotomy with tube insertion|
16066321|NCT02409680|Drug|Low dose aspirin|Daily administration of low dose (81 mg) aspirin [also known as acetylsalicylic acid (ASA], initiated between 6 0/7 weeks and 13 6/7 weeks GA and continued to 36 0/7 weeks GA compared to an identical appearing placebo. Compliance and outcomes will be assessed biweekly.
16066322|NCT02409680|Drug|Placebo|Placebo
16066323|NCT02409667|Biological|Secukinumab|Secukinumab for s.c. injection was supplied in single boxes each containing 2 pre-filled syringes (PFS) of 150 mg secukinumab in a 1 mL liquid formulation. Each 300 mg dose was administered as 2 PFS injections of 150 mg secukinumab.
16066326|NCT02409641|Drug|Cyclopentolatehydrochloride 0,5% eye drops|1 drop in study eye
16066327|NCT02409628|Device|EktoTherix|The EktoTherix scaffold is applied to the fresh wound resulting from a full thickness excision of non-melanoma skin cancer and then bolstered by the application of a non-adhesive foam dressing (discontinued at the first visit); both scaffold and foam dressing are secured in place using a semi-occlusive film dressing. The EktoTherix-treated wound is assessed weekly as per standard of care.
16066328|NCT02409615|Other|Hypnosis Therapy|A technique called Wakeful Hypnosis that involves suggestions for healing given to a person while in a normal state of consciousness
16066329|NCT02409615|Other|Healing Touch Therapy|Healing Touch An energery based therapy that uses light body or above body touch to help balance the energy field and energy centers of the body to restore harmony within the body for greater healing.
16066330|NCT02409602|Other|Doppler ultrasonographic examination|Dorsal clitoral artery Doppler ultrasonographic examinations will be performed regularly in 3rd and 6th months after delivery, in order to evaluate the possible effects of BIIAL on clitoral blood flow.
16066331|NCT02409589|Device|ECG|The ECG-guided PICC tip detection method will be used to identify catheter tip location during the procedural placement of the catheter. This method involves an ECG monitor which will be connected to the guidewire used for catheter placement. The changes in the ECG p-wave will guide correct PICC placement. An X-ray radiograph will be conducted to confirm the tip location after PICC placement.
16066332|NCT02409589|Procedure|Surface prediction length method|The method will estimate the length of the catheter from puncture site to the junction of superior vena cava / right atrium (SVC-RA) . Tip location is placed according to the estimated length but later on will be determinated by chest X-ray performed after the placement procedure. If the tip location is not at an ideal place, additional procedures and X-ray radiograph would be required in order to ensure proper tip location.
16066333|NCT02409576|Biological|Expanded , Activated NK cells|"Chemotherapy - Each patient will receive immunosuppressive chemotherapy before infusion of NK cells.
~Day -7 Cyclophosphamide at 60mg/kg Day -6 Fludarabine at 25mg/m2 daily for 5 days
~Radiation - Each patient will receive radiation within 48 hr of NK cell infusion to make the tumor cells more sensitive to NK cell killing Radiation 2Gy
~Cytokine support - Each pateint will receive IL-2 to support NK cell activation and expansion in vivo Day -1 alternate day for a total of 6 doses
~NK cells - Expanded activated haploidentical NK cells will be infused on day 0."
16066334|NCT02409563|Drug|Budesonide nasal spray (100 mcg bid)|
16066335|NCT02409563|Drug|Budesonide nasal spray (50 mcg bid|
16066336|NCT02409550|Other|CARATKids Questionnaire|
16066337|NCT02409537|Dietary Supplement|red wine|the individuals were given red wine to consume for 1 month then a wash out period of 1 month
16066338|NCT02409537|Dietary Supplement|resveratrol|the individuals were given resveratrol for 1 month and then 1 month wash out period
16066339|NCT02409537|Other|placebo|the individuals were given placebo for 1 month
16066340|NCT02409524|Biological|AlloVax|Personalized anti-cancer vaccine (injection of AlloStim followed immediately by the injection of CRCL)
16066341|NCT02409524|Biological|AlloStim|AlloStim (ID) injection AlloStim (IV) infusion
16066342|NCT02409524|Biological|CRCL|Autologous tumor-derived chaperone protein mixture
16066343|NCT02409511|Other|non intervention|
16066344|NCT02409498|Drug|pudendal block|preemptive pudendal nerve blockade with 10 ml of 0 .5 % Bupivacaine with epinephrine.
16066345|NCT02409498|Drug|no pudendal block|preemptive pudendal nerve blockade with 10 ml of normal saline to each side
16066593|NCT02407626|Drug|Propofol|Total intravenous anesthesia is a clinical standard procedure
16066346|NCT02409485|Behavioral|Couples Skill-Training (CST)|Patients and partners each receive a workbook and 6 one-hour telephone sessions with a Masters level trained interventionist. Manual content is tailored based on role (patient or partner). Couples participate together via speaker phone for half the sessions and patients and partners receive separate (individual) intervention calls for the other half of the sessions.
16066347|NCT02409472|Other|surveillance program after completion of primary treatment|These are two different surveillance programs for Dukes B2-C colorectal cancer patients who have no evidence of disease at the end of their front line treatment (surgery and adjuvant radio-chemotherapy, if indicated). These programs differ greatly in the frequency of diagnostic imaging. They had similar schedules of physical examinations and carcinoembryonic antigen (CEA) assessments.
16066348|NCT02409459|Drug|Injectafer|
16066349|NCT02409459|Drug|Placebo|Normal saline solution
16066350|NCT02409446|Dietary Supplement|Anthocyanin|Open pilot study. 35 patients will receive anthocyanin 160 mg x 2 p.o for 16 weeks
16066351|NCT02409433|Drug|lacosamide|"Comparison of patients treated with IV lacosamide to those treated with phenytoin in the intensive care unit setting.
~The lacosamide group will receive a loading dose of 400 mg IV, and on maintenance dose of up to 400 mg every 12 hours."
16066352|NCT02409433|Drug|Phenytoin|the phenytoin group will receive a loading dose of 20 mg/K IV, maximum of 2000 mg, given over 60 min. and will be started on a maintenance dose of 5 mg/K/day.
16066353|NCT02409420|Behavioral|Physiotherapy informed by Acceptance and Commitment Therapy|PACT Treatment consists of two 60 minute face-to-face sessions one week apart, of assessment, individualised treatment and exercise prescription, plus one follow-up phone call (lasting 20 minutes), one month after the last treatment session.
16066354|NCT02409407|Drug|Misoprostol , Prostaglandins E1 analogue|
16066355|NCT02409394|Drug|Hetrombopag Olamine|
16066356|NCT02409381|Drug|Motore|250 mg
16066357|NCT02409381|Drug|Alivium|600 mg
16066358|NCT02409368|Drug|Nivolumab|
16066359|NCT02409355|Drug|Atezolizumab|Atezolizumab will be administered at a dose of 1200 milligrams (mg) by IV infusion on Day 1 of each 21-day cycle until loss of clinical benefit.
16066360|NCT02409355|Drug|Carboplatin|Carboplatin will be administered at area under the concentration-time curve (AUC) 5 IV infusion once on Day 1 of each 21-day cycle for 4 or 6 cycles.
16066361|NCT02409355|Drug|Cisplatin|Cisplatin will be administered at 75 milligrams per square meter (mg/m^2) IV infusion once on Day 1 of each 21-day cycle for 4 or 6 cycles.
16066362|NCT02409355|Drug|Gemcitabine|Gemcitabine will be administered at 1000 mg/m^2 (when coadministered with carboplatin) or 1250 mg/m^2 (when coadministered with cisplatin) IV infusion on Days 1 and 8 of each 21-day cycle for 4 or 6 cycles.
16066363|NCT02409342|Drug|Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody|Atezolizumab 1200 milligram (mg) will be administered as intravenous infusion every 21 days until loss of clinical benefit (as assessed by the investigator), unacceptable toxicity, or death (maximum up to approximately 58 months).
16066364|NCT02409342|Drug|Carboplatin|Carboplatin will be administered as intravenous infusion at a dose of area under the concentration-time curve (AUC) 6 when given in combination with pemetrexed or at a dose of AUC 5 when given in combination with gemcitabine, every 21 days for 4 or 6 cycles as per local standard of care.
16066365|NCT02409342|Drug|Cisplatin|Cisplatin will be administered as intravenous infusion at a dose of 75 mg per meter squared (mg/m^2) every 21 days for 4 or 6 cycles as per local standard of care.
16066366|NCT02409342|Drug|Gemcitabine|Gemcitabine will be administered as intravenous infusion at a dose of 1250 mg/m^2 (in combination with cisplatin) or 1000 mg/m^2 (in combination with carboplatin), on Days 1 and 8 of each 21-day cycle for 4 or 6 cycles as per local standard of care.
16066367|NCT02409342|Drug|Pemetrexed|Pemetrexed will be administered as intravenous infusion at a dose of 500 mg/m^2 on Day 1 of each 21-day cycle as per local standard of care until disease progression (per RECIST v1.1), unacceptable toxicity, or death (maximum up to approximately 58 months).
16066368|NCT02409329|Behavioral|REACH|The intervention consists of daily text messaging tailored to user's individual barriers to medication adherence, text messages assessing user's adherence with feedback on progress, plus text messaging targeting other self-care behaviors.
16066369|NCT02409329|Behavioral|Helpline and A1c results|Participants complete study assessments, receive text messages advising how to access study A1c results, receive quarterly newsletters on healthy living with diabetes, and have access to a helpline for study- or diabetes medication-related questions.
16066370|NCT02409329|Behavioral|REACH + FAMS|The intervention consists of REACH individually-focused text messaging, plus family-focused phone coaching session, goal-focused text messaging, and the option to invite a family member/support person to receive text messaging.
16066371|NCT02409316|Drug|[18F]FES|[18F]FES PET/CT scan
16066372|NCT02409303|Behavioral|Screen-Refer-Treat Intervention|This intervention is healthcare system intervention that trains providers on validated screening tools (Online M-CHAT-R/F and STAT) and an evidence-based behavioral intervention (RIT). PCPs receive a 2-hour training workshop on the Online M-CHAT-R/F and EI Providers receive 2 day-long training workshops, one on the STAT/expedited assessment and one RIT.
16066373|NCT02409290|Drug|Regimen A locally-used WHO-approved MDR-TB regimen (2011 guideline)|Drug: Locally-used WHO-approved MDR-TB regimen
16066374|NCT02409290|Drug|Moxifloxacin|Moxifloxacin is an 8-methoxy quinolone, and an anti-bacterial fluoroquinolone
16066375|NCT02409290|Drug|Clofazimine|Clofazimine, is an antileprosy and anti-bacterial agent. Its chemical name is 3-(p-chloroanilino)-10-(p-chlorophenyl)-2, 10-dihydro-2-sopropyliminophenazine.
16066376|NCT02409290|Drug|Ethambutol|Ethambutol is a bacteriostatic that acts against virtually all strains of Mycobacterium tuberculosis and M. bovis and is also active against other mycobacteria such as M. Kansasii.
16066377|NCT02409290|Drug|Pyrazinamide|Pyrazinamide is bactericidal against intracellular mycobacterium tuberculosis. It is a prodrug that is converted into its active form, pyrazinoic acid, by a mycobacterial enzyme, pyrazinamidase, as well as through hepatic metabolism.
16066378|NCT02409290|Drug|Isoniazid|Isoniazid is a bactericidal in vitro and in vivo against actively dividing tubercle bacilli. Its primary action is to inhibit the synthesis of long-chain mycolic acids, which are unique constituents of mycobacterial cell wall.
16066379|NCT02409290|Drug|Prothionamide|Prothionamide has a bacteriostatic action.
16066380|NCT02409290|Drug|Kanamycin|Kanamycin is a bactericidal antibiotic from the group of aminoglycosides.
16066381|NCT02409290|Drug|Levofloxacin|Levofloxacin is a synthetic antibacterial agent of the fluoroquinolone class that acts on the DNA-DNA-gyrase complex and topoisomerase IV. It is the S (-) enantiomer of the racemic active substance ofloxacin.
16066382|NCT02409290|Drug|Bedaquiline|Bedaquiline is a novel diarylquinoline antibiotic with bactericidal activity
16066383|NCT02409277|Other|Experimental: Standard vs Intensive e-AT Intervention|Patients will be self-monitoring their symptoms weekly using the e-AT, either the Standard or Intensive versions of the e-AT, completing the Asthma Control Test. As patients complete their assessments each week, the clinics will be able to see how each patient is doing, and follow-up when a patient is showing high symptoms for that week, potentially avoiding Emergency Room visit, and/or hospitalization.
16066384|NCT02409264|Other|Individualised Homeopathic Remedy|Sucrose pillules will be medicated with the individualised homeopathic remedy as determined by the researcher, in the potency, dosage and repetition determined by the researcher in accordance with the laws governing homeopathic prescribing.
16066385|NCT02409251|Behavioral|Education and feedback|
16066386|NCT02409238|Drug|Metformin|Metformin dosage schedule: 250 mg thrice a day titrated from 250 mg once a day. Patients will first be started on Metformin 250 mg once a day with meals, and the dose increased to 250 mg twice a day at Day 8, to 250 mg three times a day at Day 15, subject to reports of poor tolerance of gastrointestinal symptoms or other side effects.
16066387|NCT02409238|Behavioral|Intensive Lifestyle Intervention|"The intensive lifestyle interventions for the Active Intervention groups will be done at the Lifestyle Intervention Centres. The aim would to achieve and maintain a weight reduction of at least 7 percent of initial body weight through a healthy reduced-calorie, low-fat diet and engagement in physical activity of moderate intensity for at least 150 minutes per week.
~This will be accomplished through a programme of individualized fitness assessment and exercise prescription for cardiovascular, strength and functional training that is standardized across study sites and facilities. The programme comprises an initial 32 sessions (2 times weekly) for supervised gym workout over 16 weeks, followed by maintenance programme of regular unsupervised exercises."
16066388|NCT02409238|Behavioral|Standard LIfestyle Recommendation|The standard lifestyle recommendations for the Control groups are in the form of standard diabetic education pamphlets and a 20-to-30-minute individual session that emphasizes the importance of a healthy lifestyle to reduce their weight and to increase their physical activity. Activity will be monitored using a pedometer.
16066389|NCT02409225|Device|Home Monitoring|Remote monitoring of ICD/CRT-D function and patient condition allow decreasing costs of treatment of patients with ICD/CRT-D (hospitalization, visits in outpatient clinic) and reducing waiting time for medical intervention (remote or in outpatient clinic).
16066390|NCT02409225|Device|no Home Monitoring|Patients with ICD/CRT-D devices provided by St Jude Medical, Biotronik or Medtronic with HM option switched off.
16066391|NCT02409212|Behavioral|Aerobic exercise training|Aerobic exercise training will be undertaken for 12 months, combining supervised and independent exercise sessions. Behaviour change counselling will take place bi-monthly, either via face to face sessions during exercise or via telephone by study clinical exercise specialist according to participant preference.
16066392|NCT02409212|Behavioral|Placebo surveillance and written exercise guidelines|Optimal active surveillance according to NICE guidelines and written exercise guidelines from Macmillan cancer
16066393|NCT02409199|Drug|Docetaxel|
16066394|NCT02409199|Drug|apatinib|
16066395|NCT02409186|Drug|Nimotuzumab|400mg/w，d1, week 1-7
16066396|NCT02409186|Radiation|radiotherapy|Three dimensional conformal RT（3DCRT）/IntensityModulatedRadiationTherapy（IMRT）：1.8 Gy/f/day, T59.4 Gy/33f,week 1-7
16066397|NCT02409186|Drug|chemoradiotherapy Paclitaxel|45 mg/m2, d1, week 1-7
16066398|NCT02409186|Drug|chemoradiotherapy Cisplatin|20 mg/m2, d1, week 1-7
16066399|NCT02409186|Other|placebo|400mg/w，d1, week 1-7
16066400|NCT02409173|Device|Noninvasive positive airway pressure flow generator device|Noninvasive positive airway pressure flow generator device.
16066401|NCT02409173|Procedure|Bariatric Surgery|Standard Roux-en-Y gastric bypass
16066402|NCT02409160|Procedure|Standard Roux-en-Y gastric bypass|
16066403|NCT02409147|Procedure|Uterine Transplant|Surgical implantation of a deceased donor uterus, induction therapy with thymoglobulin or basiliximab, maintenance immunosuppression with Prograf, Cellcept, and Prednisone. Anti-infective treatment with Bactrim and Valcyte and Nystatin. Anti-platelet therapy with aspirin. IVF per standard protocol. At time of birth: ceasarean section. Ultimately, transplant hysterectomy.
16066404|NCT02409121|Behavioral|Education information system|Participants will receive a mobile tablet as an educational intervention during the patient's inpatient hospitalization
16066405|NCT02409108|Device|Exatherm-TBH system|One treatment of Total Body Hyperthermia
16066406|NCT02409095|Biological|DTP-HB-Hib vaccine|Diphtheria, Tetanus, Pertussis, Hepatitis-B and Haemophilus influenzae type-B conjugate vaccine (DTP-HB-Hib) has been developed and manufactured by SIIL. The vaccine is pre-qualified by WHO and licensed by the Indian regulatory authority for immunization in children to protect them against above five diseases.
16066407|NCT02409095|Device|Disposable Syringe Jet Injector (DSJI)|Stratis is a needle free injection device manufactured by Pharamjet Inc. and licensed in USA.
16066408|NCT02409095|Other|Needle & Syringe|The conventional needle syringe that is routinely used for vaccination.
16066409|NCT02409069|Device|Transcutaneous vagus nerve stimulation (Nemos®, Cerbomed GmbH)|
16066410|NCT02409069|Device|Sham stimulation (Nemos®, Cerbomed GmbH)|
16066411|NCT02409056|Behavioral|Workplace-tailored CDSMP|This is the CDSMP program which has been modified to fit the unique characteristics of the workplace and will be offered in worksites.
16066412|NCT02409056|Behavioral|Chronic Disease Self-Management Program|This is the standard CDSMP which has been implemented in community settings.
16066413|NCT02409043|Other|Blood draw|Blood drawn for comparison with other groups
16066414|NCT02409043|Other|Stroke blood draw|Participants presenting at the University of Florida Shands Emergency Department with an ischemic stroke. Blood drawn at day 1, day 3, and at 2-8 weeks after stroke, NIH stroke scale scores, modified Rankin scale scores, blood pressure, MRI infarct volumes, and hospital length of stay taken from the medical records. 3 month modified Rankin scale score collected by phone interview.
16066415|NCT02409017|Procedure|Insulin drip|
16066416|NCT02409004|Drug|Ataluren|Powder for oral suspension (supplied in sachets) 1X 125 mg + 1 x 250 mg + 1000 mg (total of 1375 mg)
16066418|NCT02408991|Drug|Neupogen|Neupogen is given as an injection in your skin every three days for a total of 5 doses.
16066419|NCT02408991|Device|Art-Assist Device|The programmed pneumatic compression device (PPCD) is to be worn for a minimum of three hours daily while patient is sitting down
16066420|NCT02408978|Drug|OXP005|
16066421|NCT02408978|Drug|Naproxen|
16066422|NCT02408965|Drug|Methergine|0.2 mg of methylergonovine maleate
16066423|NCT02408965|Other|placebo|saline placebo to maintain blinding
16066424|NCT02408952|Behavioral|Primary Care Physician|The screening, brief intervention and referral to treatment is delivered by the Primary Care Physician
16066425|NCT02408952|Behavioral|Behavioral Medicine Specialist|The screening, brief intervention and referral to treatment is delivered by the Behavioral Medicine Specialist.
16066426|NCT02408939|Drug|Stress-dose hydrocortisone|Patients with postresuscitation shock received stress-dose (300 mg) of hydrocortisone for 7 days maximum followed by gradual taper and discontinuation over 48 hours after either the resolution of their hemodynamic instability or day 7 of treatment.
16066427|NCT02408926|Biological|Boostrix|Pregnant women will be vaccinated with an acellular pertussis containing vaccine between 27 and 36 weeks of gestation.
16066428|NCT02408926|Biological|Infanrix hexa|Children from group A will be vaccinated with an acellular pertussis containing vaccine according to the official recommendations in Thailand at 2, 4, 6 and 18 months.
16066429|NCT02408926|Biological|Quinvaxem|Children from group B will be vaccinated with a whole cell pertussis containing vaccine according to the official recommendations in Thailand at 2, 4, 6 and 18 months.
16066430|NCT02408926|Biological|OPV|Children from group B will be vaccinated with OPV vaccine according to the official recommendations in Thailand at 2, 4, 6 and 18 months.
16066431|NCT02408913|Biological|VRC-EBOMVA079-00-VP (MVA-EbolaZ)|Ebola Modified Vaccinia Virus Ankara Vaccine
16066432|NCT02408913|Biological|VRC-EBOADC069-00-VP (cAd3-EBO)|Ebola Chimpanzee Adenovirus Vector Vaccine
16066437|NCT02408848|Other|Observational|This is an observational study. There is no intervention.
16066438|NCT02408835|Device|PICO™|Negative pressure wound therapy device for closed surgical wounds.
16066439|NCT02408822|Device|PTA Balloon dilatation catheter Advance® (Cook® Medical)|2-minutes inflation of the plain balloon on pre-dilated stenosis segment, at nominal pressure
16066440|NCT02408822|Device|Drug-eluting PTA Balloon dilatation catheter Advance® 18 PTX®|2-minutes inflation of the drug-eluting balloon on pre-dilated stenosis segment, at nominal pressure
16066441|NCT02408809|Behavioral|General Smoking Cessation Discussion|This group receives the 5 A's of smoking cessation counseling incorporating how cigarette smoking negatively impacts general health (cancer, MI). 10 minutes in length.
16066442|NCT02408809|Behavioral|Orthopaedic Related Smoking Cessation Discussion|The participants in this group receive a discussion including the 5 A's of smoking cessation counseling incorporating an orthopaedic related smoking cessation discussion about the effects of smoking cigarettes on the musculoskeletal system. 10 minutes in length.
16066443|NCT02408796|Drug|OTO-201|
16066444|NCT02408770|Drug|ulipristal acetate|selective progesterone receptor modulator
16066445|NCT02408757|Procedure|Sonographic monitoring|Sonographic monitoring during weaning of cerebrospinal fluid drainage catheters
16066446|NCT02408744|Drug|Pirfenidone|Pirfenidone was supplied orally in the form of prolonged-released tablets according with body surface area (m2 BS) of each patient. The target dosage of PFD was 1200 mg two times a day (b.i.d.) for a full dosage of 2400 mg daily during three years. Therapy was initiated at 600 mg b.i.d. and escalated to full dosage after 3 weeks when symptoms were controlled.
16066447|NCT02408731|Drug|PMZ-2010 (Centhaquin)|As per the randomization schedule, injection of PMZ-2010 or placebo (100 ml normal saline) will be administered to each subject under supervision of investigator as an intravenous infusion over one hour. PMZ-2010 will be dissolved in normal saline (100 ml) before administration.
16066448|NCT02408718|Behavioral|Assistive Device Training|Six-week training program on the proper use of the subject's assistive device (eg. cane, walker, etc).
16066449|NCT02408705|Drug|Liraglutide|They are receiving liraglutide for 3 months. Dose escalation: 0.3 mg - 0.6mg - 0.9mg - 1.2mg (over 4 weeks)
16066450|NCT02408705|Drug|Placebo|They are receiving placebo for 3 months. Dose escalation: 0.3 mg - 0.6mg - 0.9mg - 1.2mg (over 4 weeks)
16066451|NCT02408705|Drug|Mixed Meal Tolerance Test with paracetamol|At the beginning and end of each period (Visit 2a, 8, 9a, 15) a Mixed Meal Tolerance Test enriched paracetamol will be performed.
16066452|NCT02408692|Drug|ECx1|At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). After this visit, women with a BMI of <25 kg/m2 will have completed study participation.
16066453|NCT02408692|Drug|ECx2|At the first treatment visit, all women will be given the study drug (1.5 mg of levonorgestrel) and several blood samples will be taken over 2.5 hours). For women with a BMI of 30kg/m2 and greater, one additional visit will be required and study drug (3 mg of levonorgestrel) will be given and several blood samples will be taken over 2.5 hours)
16066454|NCT02408679|Procedure|Blood sampling|One blood sampling will be performed for a serum vitamin D dosage. The volume of blood collected will not exceed 4 ml.
16066455|NCT02408679|Other|Predictive questionnaire for vitamin D insufficiency|The questionnaire includes 19 questions concerning the following topics : a) sun exposure, b) living situation, c) eating habits and Vitamin D dietary intakes. In addition, two questions will capture demographic data.
16066456|NCT02408666|Other|Interview|
16066457|NCT02408653|Device|EEG|
16066458|NCT02408640|Behavioral|Cannabishjalpen.se|
16066459|NCT02408627|Device|EEG|
16066460|NCT02408614|Other|Slow-paced walking|Subjects will complete 47 minutes of walking on a treadmill at a slow-pace.
16066461|NCT02408614|Other|Moderate-paced walking|Subjects will complete 47 minutes of walking on a treadmill at a moderate pace.
16066462|NCT02408614|Other|Interval Training|Subjects will complete 40 minutes of walking on the treadmill alternating between a moderate and a fast pace.
16066464|NCT02408601|Other|Helioseal - F|"Helioseal -F ( Resin based sealant)
~isolate the tooth surface
~etch the fissure anatomy with 37% phosphoric acid for 20 seconds
~wash the tooth surface and dry it. No salivary contamination is accepeted
~using a syringe based system, apply the sealant onto the fissures, do not overfill the fissures, run an explorer along the fissures to avoid any air entrapment.
~light cure the sealant
~check for high points and the occlusion"
16066465|NCT02408601|Other|ART sealant|"Fuji IX extra strength
~isolate the tooth surface
~condition the fissure anatomy using a GC conditioner for 10 seconds
~wash the conditioner by using a cotton pellet for a couple of times, do not use a three way syringe.
~dry the tooth surface
~mix the GIC according to the standard powder: liquid ratio
~place the mix onto the fissures using a plastic spatula
~apply pressure on the occlusal surface with a gloved index finger( the gloved index finger must be coated with petroleum jelly)
~apply pressure for 10-15 sec and withdraw the finger in a sideways motion
~scrap out the excess material
~check for the high points and the occlusion
~apply petroleum jelly onto the GIC mix
~advice patient not to eat or drink for 30 minutes."
16066466|NCT02408588|Other|Pulse oximeter|Place a pulse oximeter on the subject which will record the pulse oximeter waveform.
16066467|NCT02408575|Device|Notched filtering (verum)|Conventional hearing aid type Carat 7bx with M-Receiver Adjustment by Connexx 7.3 The Hearing aid with notched amplification filters frequences in a specific manner, depending on the individual tinnitus frequency. Through this special filtering the neuronal functional changes of the auditory cortex are supposed to be affected therapeutically.
16066468|NCT02408575|Device|No filtering (placebo)|"Conventional hearing aid type Carat 7bx with M-Receiver Adjustment by Connexx 7.3
~No notched filtering"
16066469|NCT02408562|Other|i.c.v. infusion of sNN0031 by an Implanted infusion system|I.c.v. infusion during 2 12d cycles separated by 3 mo. 6 mo follow-up after 2nd cycle.
16066470|NCT02408562|Other|i.c.v. infusion of aCSF by an Implanted infusion system|I.c.v. infusion during 2 12d cycles separated by 3 mo. 6 mo follow-up after 2nd cycle.
16066471|NCT02408549|Drug|Lacosamide Tablet|"Active substance: Lacosamide
~Pharmaceutical form: Tablet
~Concentration: 50 mg and 100 mg
~Route of Administration: oral administration"
16066472|NCT02408549|Drug|Lacosamide Oral Solution|"Active substance: Lacosamide
~Pharmaceutical form: Oral solution
~Concentration: 10 mg/ml
~Route of Administration: Oral administration"
16066473|NCT02408523|Drug|Lacosamide Tablet|"Active Substance: Lacosamide
~Pharmaceutical Form: Film-coated Tablet
~Concentration: 50 mg
~Route of Administration: Oral use"
16066474|NCT02408523|Drug|Lasosamide Oral Solution|"Active Substance: Lacosamide
~Pharmaceutical Form: Oral Solution
~Concentration: 10 mg/ml
~Route of Administration: Oral use"
16066475|NCT02408523|Other|Placebo Tablet|"Active Substance: Placebo
~Pharmaceutical Form: Film-coated Tablet
~Concentration: 50 mg
~Route of Administration: Oral use"
16066476|NCT02408523|Other|Placebo Oral Solution|"Active Substance: Placebo
~Pharmaceutical Form: Oral Solution
~Concentration: 10 mg/ml
~Route of Administration: Oral use"
16066477|NCT02408484|Biological|Octafibrin|Plasma-derived Fibrinogen concentrate
16066478|NCT02408471|Device|Ascension® MCP Finger Implant|Patients who meet inclusion/ exclusion criteria are treated with the Ascension® MCP.
16066479|NCT02408458|Device|MIROMESH®|
16066480|NCT02408445|Drug|testosterone cypionate 200mg/ml|Subjects in this group will be randomized to receive testosterone cypionate 200 mg/ml to be given intramuscularly every 4 weeks for a total of 3 doses.
16066481|NCT02408432|Biological|Mesenchymal Stem Cell Transplantation|Undergo mesenchymal stem cell infusion Drug: Standard of Care for Heart Failure Both groups will also receive standard of care drugs for heart failure. The study doctor will tell you which drugs you are taking, their risks, and when you should take them.
16066482|NCT02408432|Drug|Standard of Care for Heart Failure|Both groups will also receive standard of care drugs for heart failure. The study doctor will tell you which drugs you are taking, their risks, and when you should take them.
16066483|NCT02408419|Drug|Bupivacaine|Bupivacaine is injected proximally to anesthetize the obturator nerve
16066484|NCT02408419|Drug|Saline|Saline is injected as a placebo
16066485|NCT02408406|Other|Communication Intervention|Use PatientCareAnywhere system
16066486|NCT02408406|Other|Educational Intervention|Use PatientCareAnywhere system
16066487|NCT02408406|Other|Internet-Based Intervention|Use PatientCareAnywhere system
16066488|NCT02408406|Other|Quality-of-Life Assessment|Ancillary studies
16066489|NCT02408406|Other|Questionnaire Administration|Ancillary studies
16066490|NCT02408393|Drug|Saline|
16066491|NCT02408393|Drug|Ropivacaine|
16066492|NCT02408367|Behavioral|Exercise|30 minutes endurance training at 75% of the Maximum heart rate
16066493|NCT02408367|Behavioral|Relaxation|30
16066494|NCT02408354|Drug|Triheptanoin|"Triheptanoin is a triglyceride composed of three heptanoate (C7 fatty acid) esters. Triheptanoin is manufactured by chemical synthesis from glycerol and heptanoic acid. Triheptanoin is a liquid, intended for oral (PO) administration.
~Participants will be given approximately 1g/kg of Triheptanoin divided at least in three doses (at 8 am, 12 noon, and 8 pm). A one-day titration period will be used, using 0.5 g/kg increments before arriving at the full dose."
16066495|NCT02408354|Drug|Placebo|Placebo is a oily liquid, intended for oral (PO) administration. Participants will be given approximately 1g/kg of Placebo divided at least in three doses (at 8 am, 12 noon, and 8 pm). A one-day titration period will be used, using 0.5 g/kg increments before arriving at the full dose.
16066496|NCT02408328|Drug|Caffeine citrate|Loading dose and continues use of caffeine until 44 weeks postmenstrual age
16066497|NCT02408328|Device|Home monitor|Use of home monitor until 44 weeks postmenstrual age
16066498|NCT02408328|Other|Continued inpatient monitoring until apnea resolution|Continued inpatient monitoring until apnea resolution
16066499|NCT02408315|Drug|misoprostol/placebo|buccal or vaginal routes of administration/ placebo to compare methods for efficacy and safety during induction.
16066500|NCT02408302|Drug|Midazolam|comparison between 3 routes of administration of the drug Midazolam used for sedation for minor procedures in pediatric population. the routes are oral intranasal and buccal.
16066501|NCT02408289|Dietary Supplement|Lo-Flav|low-flavonoid cocoa powder with 0 mg of procyanidins and 0 mg epicatechin per kg of body weight will be consumed as a beverage.
16066594|NCT02407626|Drug|Sevoflurane|Volatile anesthesia is a clinical standard procedure
16066996|NCT02404766|Other|C0-C1 dorsal glide manual mobilization|
16066502|NCT02408289|Dietary Supplement|Hi-Flav|High-flavonoid cocoa powder with 3.8 mg procyanidins per kg of body weight and 0.6 mg Epicatechin per kg of body weight will be consumed as a beverage.
16066503|NCT02408289|Dietary Supplement|Epicatechin|Low-flavonoid cocoa powder plus 1 mg epicatechin per kg of body weight will be consumed as a beverage
16066504|NCT02408289|Dietary Supplement|Procyanidins|Low-flavonoid cocoa powder plus 3.7 mg procyanidins per kg of body weight will be consumed as a beverage.
16066505|NCT02408276|Other|dGEMERIC MRI technique|"Patients will be treated surgically (hip arthroscopy) or nonoperatively (physical therapy) and pain medications as needed. For surgical patients, cartilage samples and surgeon operative reports will be a source of research. For both cohorts, MRIs, radiographs and patient reported outcome surveys will be additional research sources.
~All tests and imaging are part of standard of care except follow up MRI, which will be performed in a random group from within the cohort and paid for through this grant."
16066506|NCT02408263|Procedure|Total Hip Replacement (THR) and Total Knee Replacement (TKR)|Total Hip Replacement is a surgical procedure where the cartilage and bone of the hip joint is replaced with artificial materials. Total Knee Replacement involves replacement of all three compartments of the knee the medial, the lateral and patellofemoral compartment.
16066507|NCT02408250|Procedure|Exercise program|Exercise program in intensive care unit established from a decisional algorithm and applied to the critical care unit patients
16066508|NCT02408237|Device|Active tDCS Ambulatory|Procedure begins with the placement of an anode electrode placed on the primary motor cortex (cortex contralateral to the dominant) and the cathode is placed on the contralateral supraorbital region. It is used 1mA direct current transcranial stimulation applied for 20 minutes. Will be held a single session of stimulation. The total time, with initial assessment, tDCS session and final evaluation will be approximately 4 hours.
16066509|NCT02408237|Device|Sham tDCS Ambulatory|In sham group, we follow the same procedure and time as the active tDCS ambulatory protocol, but the device will be in the mode sham (inactive). The current is only applied for 30 seconds, so subjects feel a sense of the initial stimulation, but not the remainder receive current. In this group one session will also be held. The total time, with initial assessment, tDCS session and final evaluation will be approximately 4 hours.
16066510|NCT02408237|Device|Active tDCS Home use|The procedure and stimulation time is exactly the same that Active tDCS - ambulatory use, but will use the apparatus for domestic use. Will be explained to the participant as placement of the cap and the device management. This group will be made 11 sessions of tDCS, the first held in the Hospital, with supervision of the researcher. The remaining 10 will be held in the participant's home. The total time of the first meeting, with initial assessment, tDCS session and final evaluation will be around 4 hours. The time of last evaluation is approximately 1 hour.
16066511|NCT02408237|Device|Sham tDCS Home use|The procedure and stimulation time is exactly the same that Active tDCS - ambulatory use, but will use the apparatus for domestic use. In sham group, we follow the same procedure and time as the active tDCS protocol, but the device will be in the sham mode (inactive). The total time of the first meeting, with initial assessment, tDCS session and final evaluation will be around 4 hours. The time of last evaluation is approximately 1 hour.
16066512|NCT02408198|Behavioral|Anxiety intervention|The intervention is based on a brief CBT for psychosis (CBTp) programme, focusing on understanding and managing anxiety processes that contribute to persecutory threat beliefs when in busy urban environments. The novel aspect of this intervention is that it is delivered in a group format. The intervention consists of six sessions which will be delivered on a weekly basis. Throughout the intervention there is an emphasis on setting tasks to practice applying the new skills outside of sessions, to help the person build confidence in being able to manage paranoia and feel less distressed in their daily life.
16066513|NCT02408185|Drug|Colistin 6 million units + 240mg/8h|240 mg of colistin methanesulfonate (CMS) every 8 hours, 3 million units (MU); 90 mg colistin base activity, (CBA)
16066514|NCT02408185|Drug|Colistin 6 million units + 360mg/12h|360 mg CMS every 12 hours (4.5 MU; 135 mg CBA)
16066515|NCT02408172|Drug|Amlodipine|Amlodipine was given orally in a dose of 5mg/day to treat patients in the OSA-amlodipine group for 12 weeks.
16066516|NCT02408172|Drug|metoprolol|Metoprolol was given orally in a dose of 47.5mg/day to treat patients in the OSA-metoprolol group for 12 weeks.
16066517|NCT02408159|Drug|Varicella Zoster Vaccine|
16066518|NCT02408159|Drug|Placebo|
16066519|NCT02408146|Procedure|conventional intravenous infusion pump|The first group receives conventional intravenous infusion pump of patient-controlled analgesia (fentanyl citrate 20 mg/mL/kg + ondansetron hydrochloride 16 mg/8 mL + normal saline) for three days after surgery. The pump is infused continuously at the basic flow rate of 2 mL/h, 0.5 mL of bolus can be injected if the patients press the button once upon experiencing pain. The lock-out time for each bolus injection is 15 minutes.
16066520|NCT02408146|Drug|parecoxib|The second group has oral celecoxib before surgery, then receives 40 mg parecoxib sodium intravenously guttae twice a day for three days after surgery.
16066521|NCT02408146|Procedure|intravenous infusion pump of patient-controlled analgesia|The third group has oral celecoxib before surgery, and receives 40 mg parecoxib sodium intravenously guttae immediately after surgery, then uses new intravenous infusion pump of patient-controlled analgesia (parecoxib sodium 1 mg/mL + normal saline) for three days after surgery. The pump is infused continuously at the basic flow rate of 2 mL/h, 0.5 mL of bolus can be injected if the patients press the button once upon experiencing pain. The lock-out time for each bolus injection is 15 minutes.
16066522|NCT02408146|Drug|fentanyl citrate+ ondansetron hydrochloride + normal saline|
16066523|NCT02408146|Drug|celecoxib|
16066524|NCT02408133|Other|Home exercise|Will be offered to the group, instructional material (manual exercises) and point you to an exercise routine to be performed independently for range of motion and muscular fitness, using the environmental resources of the same household. A daily frequency in performing this exercise routine is suggested. Also, be given incentives and guidelines for the practice of active commuting (walking) to be accumulated at least 10 to 20 minutes of this activity daily. All control guidelines and training for the use of the exercise manual will be offered through an introductory lecture and subsequent weekly telephone contacts (2 times a week). The participants in this group should fulfill their respective program for a total period of 12 weeks.
16066552|NCT02407977|Other|Novel nano-scintillatorfiber-optic dosimeter ( nanoFOD)|This is an observational study whose purpose is to determine the feasibility of using a novel nano-scintillator fiber-optic dosimeter ( nanoFOD) for real time dosimetric monitoring of external beam radiotherapy.
16066525|NCT02408120|Drug|Insulin glargine|"Half of total daily dose (TDD) will be given as insulin glargine and will be given once daily, at the same time of the day.
~Daily insulin dose will be adjusted as follow:
~If the fasting and pre-dinner BG is between 100 - 140 mg/dL in the absence of hypoglycemia the previous day: no change
~If the fasting and pre-dinner BG is between 140 - 180 mg/dL in the absence of hypoglycemia: increase basal insulin by 10% every day
~If the fasting and pre-dinner BG is >180 mg/dL in the absence of hypoglycemia the previous day: increase basal insulin dose by 20% every day
~If the fasting and pre-dinner BG is between 70 - 99 mg/dL in the absence of hypoglycemia: decrease TDD (basal and prandial) insulin dose by 10% every day
~If a patient develops hypoglycemia (BG <70 mg/dL), the insulin TDD (basal and prandial) should be decreased by 20%."
16066526|NCT02408120|Drug|Insulin aspart|"Half of total daily dose will be given as insulin aspart and in three equally divided doses before each meal. To prevent hypoglycemia, if a subject is not able to eat, the dose of aspart will be held.
~Daily insulin dose will be adjusted as follow:
~If the fasting and pre-dinner BG is between 100 - 140 mg/dL in the absence of hypoglycemia the previous day: no change
~If the fasting and pre-dinner BG is between 140 - 180 mg/dL in the absence of hypoglycemia: increase basal insulin by 10% every day
~If the fasting and pre-dinner BG is >180 mg/dL in the absence of hypoglycemia the previous day: increase basal insulin dose by 20% every day
~If the fasting and pre-dinner BG is between 70 - 99 mg/dL in the absence of hypoglycemia: decrease TDD (basal and prandial) insulin dose by 10% every day
~If a patient develops hypoglycemia (BG <70 mg/dL), the insulin TDD (basal and prandial) should be decreased by 20%."
16066527|NCT02408120|Drug|Supplemental insulin aspart|"Insulin aspart will be administered following the supplemental insulin scale protocol.
~For the arm receiving supplemental insulin aspart at BG levels greater than 140 mg/dL, then supplemental insulin scale is as follows:
~BG >141-180 mg/dL; 2-4 units of insulin aspart
~BG between 181-220 mg/dL; 3-6 units of insulin aspart
~BG between 221-260 mg/dL; 4-8 units of insulin aspart
~BG between 261-300 mg/dL; 5-10 units of insulin aspart
~BG between 301-350 mg/dL; 6-12 units of insulin aspart
~BG between 351-400 mg/dL; 7-14 units of insulin aspart
~BG > 400 mg/dL; 8-16 units of insulin aspart
~For the arm receiving supplemental insulin aspart at BG levels greater than 260 mg/dL, then supplemental insulin scale is as follows:
~BG between 261-300 mg/dL; 5-10 units of insulin aspart
~BG between 301-350 mg/dL; 6-12 units of insulin aspart
~BG between 351-400 mg/dL; 7-14 units of insulin aspart
~BG > 400 mg/dL; 8-16 units of insulin aspart"
16066528|NCT02408107|Behavioral|Physical activity|Physical activity (PA) intervention participants received a 30-45 min face-to-face consultation (1st visit), followed by 15-20 min support telephone calls (end of months 1, 2 and 3). During months 4 and 5 patients received reminder leaflets. Consultations were conducted by the primary researcher after baseline measurements and were based on the four core motivational interviewing principles. The topics covered in the consultation (e.g. goal setting, overcoming barriers, health and safety advice) were similar to other trials that incorporated a PA counselling component. The focus of the follow-up phone calls (end of months 1-3) was to prevent relapse and/or improve maintenance of PA. The intervention participants were encouraged to work towards accumulating at least 30min of moderate-intensity PA on 5-7 days/week.
16066529|NCT02408081|Behavioral|Family Focused Nursing|All patients receive treatment as usual. Additionally, patients in the intervention arm receives family focused nursing consultations which are structured as sessions focusing on change, improvement and/or maintenance of family function within cognitive, affective and behavioral knowledge. Each session is organized and individualized according to the wishes and needs for education and counseling of the families within a period of one months.
16066530|NCT02408068|Drug|Dexamethasone|Dexamethasone used to suppress endogenous cortisol secretion
16066531|NCT02408068|Drug|Chronocort: fasted|single dose of 20mg modified release hydrocortisone in the absence of food
16066532|NCT02408068|Drug|Immediate release hydrocortisone: fasted|single dose of 20mg immediate release hydrocortisone in the absence of food
16066533|NCT02408068|Drug|Chronocort: fed|single dose of 20mg modified release hydrocortisone in the presence of food
16066534|NCT02408055|Drug|TA-8995|
16066535|NCT02408042|Drug|Pembrolizumab|
16066536|NCT02408042|Drug|Etoposide|
16066537|NCT02408042|Drug|Ifosfamide|
16066538|NCT02408042|Drug|Mesna|
16066539|NCT02408042|Drug|Carboplatin|
16066540|NCT02408042|Drug|Brentuximab vedotin|
16066541|NCT02408042|Drug|Rituximab|
16066542|NCT02408029|Other|Observational study - no intervention|
16066543|NCT02408016|Biological|Aldesleukin|Given SC
16066544|NCT02408016|Biological|Autologous WT1-TCRc4 Gene-transduced CD8-positive Tcm/Tn Lymphocytes|Given IV
16066545|NCT02408016|Drug|Cyclophosphamide|Given IV
16066546|NCT02408016|Other|Laboratory Biomarker Analysis|Correlative studies
16066547|NCT02408016|Procedure|Therapeutic Conventional Surgery|Undergo surgical resection
16066548|NCT02408003|Drug|Levosimendan|"Data is collected at baseline as two controls.
~Three physiological interventions follows, and data is collected after each:
~Increasing heart rate in two steps by atrial pacing through a temporary pacemaker.
~Raising cardiac preload by increasing central venous pressure through leg elevation.
~Raising cardiac afterload by increasing systemic vascular resistance through administering of phenylephrine.
~Baseline is restored, and data is collected before drug adminstration as two controls, then after a first (half) dose, and finally after a second (full) dose."
16066549|NCT02408003|Drug|Milrinone|"Data is collected at baseline as two controls.
~Three physiological interventions follows, and data is collected after each:
~Increasing heart rate in two steps by atrial pacing through a temporary pacemaker.
~Raising cardiac preload by increasing central venous pressure through leg elevation.
~Raising cardiac afterload by increasing systemic vascular resistance through administering of phenylephrine.
~Baseline is restored, and data is collected before drug adminstration as two controls, then after a first (half) dose, and finally after a second (full) dose."
16066550|NCT02407990|Biological|BGB-A317|"In the dose escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme. In the schedule exploration part, participants will be assigned to doses and dose schedules. In the fix dose exploration, participants will be assigned to dose group(s) not to exceed the Maximum Tolerated Dose (MTD).
~In the dose expansion part, participants will be assigned to different groups based on their tumor type."
16066551|NCT02407990|Biological|BGB-A317|Participants will be assigned to different groups based on their tumor types
16066590|NCT02407652|Behavioral|Low Cognitive Load Training|10 low cognitive load sessions, 400 trials each
16066553|NCT02407951|Behavioral|CBIT group|"Child group: 8 weekly group sessions lasting 90 mins, additional three monthly booster sessions.
~During sessions, children create a tic hierarchy from most to least distressing, with more distressing tics addressed earlier in the treatment. Awareness training and competing response training is implemented and practiced. Competing response training is added, involving engagement in a voluntary behavior physically incompatible with the tic, contingent on the premonitory urge or other signs of impeding tic occurrence. Relaxation training addresses situations that sustained or worsened tics, training focuses on developing individual behavioral strategies to reduce the influence of these factor.
~Parallel parent-group sessions simultaneously run during first 4 sessions of child-group. parents-group includes psycho-education and use of reward strategies.
~Meetings executed by two trained clinicians."
16066554|NCT02407951|Behavioral|Psycho-Educational group|"Child group: 8 weekly group sessions lasting 90 mins each, as well as additional three monthly booster sessions afterwards.
~During the educational group sessions, each session will focus on educating the participants in regard to a specific subject: Tourette syndrome, Self-esteem, Anger, OCD (obssesive compulsive disorder), School and bullying, Anxiety, Attention, and a final session Quiz.
~Parent group: Parent-group sessions will simultaneously run during the first 4 sessions of the child-group. The parents-group will include psycho-education and the use of reward strategies.
~All group meetings will be executed and managed by two trained clinicians."
16066555|NCT02407938|Other|Rice meal|
16066556|NCT02407925|Behavioral|Feedback|3-monthly or no 3-monthly feedback on results of optical diagnosis
16066557|NCT02407912|Drug|cisplatin|ciplatin in distilled water is injected into the chest for 48 h.
16066558|NCT02407899|Drug|Saxagliptin|Take saxagliptin tablet 5mg p.o. qd. for 104 weeks after randomization.
16066559|NCT02407899|Drug|Vitamin D3|Take vitamin D drops 2000 IU p.o. qd. for 104 weeks after randomization.
16066560|NCT02407899|Drug|Insulin|For optimal control of patients' glucose, researchers can initiate insulin therapy at any time in this trial, choose any brands of insulin after discussion with the patient.
16066561|NCT02407899|Drug|Metformin|Take Metformin tablet 1.5g p.o. per day for 104 weeks (adjust the dose between 1-1.7g per day according to subject's specific situation) before or after randomization.
16066562|NCT02407873|Other|Non|
16066563|NCT02407860|Other|osteopathic treatment|Treatment duration range between 30 to 40 minutes. The infant entire body is evaluated and then manipulative procedures are provided following palpatory results.
16066564|NCT02407860|Other|usual breastfeeding counselling|breastfeeding counselling and support by lactation consultant
16066565|NCT02407847|Other|care provided by Nurse Practitioners|Patients will receive care at the Primary Out of Hours Emergency Service by a Nurse Practitioner instead of a General Practitioner (substitution of care from physicians to nurses).
16066566|NCT02407834|Other|S1|Immersion in 0.25% sodium hypochlorite for 20 minutes, during 7 days.
16066567|NCT02407834|Other|S2|Immersion in 0.5% sodium hypochlorite for 20 minutes, during 7 days.
16066568|NCT02407834|Other|S3|Immersion in 10% Ricinus communis for 20 minutes, during 7 days.
16066569|NCT02407834|Other|S4|Immersion in Saline solution for 20 minutes, during 7 days.
16066570|NCT02407821|Drug|Escitalopram|Dose will be initiated at 5 mg daily. At two weeks, a safety and tolerability assessment will be performed, and if tolerated, the dose will be increased to 10 mg daily. At 24 weeks, the medication will be titrated downwards to 5 mg daily for a further two weeks before discontinuation.
16066571|NCT02407821|Drug|Placebo|The matching placebo will be up-titrated and down-titrated at the same time intervals as the active medication.
16066572|NCT02407808|Drug|THC|Active THC (0.0015-0.03 mg/kg) administered over 20 minutes.
16066573|NCT02407808|Drug|Placebo|Control: small amount of alcohol intravenously (quarter teaspoon), with no THC over 20 minutes.
16066574|NCT02407795|Radiation|conventional radiotherapy|1x8Gy
16066575|NCT02407795|Radiation|stereotactic radiotherapy|1x20Gy or equivalent dose fractionation schedule
16066576|NCT02407782|Drug|Ivermectin|oral ivermectin, 200μg/kg given at baseline and at day 10.
16066577|NCT02407782|Drug|Permethrin|topical permethrin 5% cream applied at baseline and at day 10.
16066578|NCT02407769|Dietary Supplement|Late evening supplementation with branched chain amino acids|The patients will drink a Enterex Hepatic bag (500 Kcal, 18.6g of proteins of which 8.63g are branched chain amino acids, 71.7g of carbohydrates and 15.4g of lipids) during late evening (after 19:00 hours) in comparison with the late evening snack group which will eat a snack based in food with the next nutrimental facts (480 Kcal, 19g of proteins based in casein and vegetables sources, 17g of lipids and 63g of carbohydrates) during the same schedule that intervention group.
16066579|NCT02407756|Drug|Dupilumab|
16066580|NCT02407743|Behavioral|Surgical patients' clinical progression|Study the dynamic nature of pain
16066581|NCT02407743|Genetic|Genetic markers|Research variants in genes related to pain sensitivity, analgesic sensitivity and opioid response
16066582|NCT02407704|Drug|Venlafaxine XR|
16066583|NCT02407704|Other|Aerobic Exercise|
16066584|NCT02407704|Drug|Lorazepam|Lorazepam may be used in the study for patients who either are already on this drug or who need it for sleep and/or anxiety. Patients taking another benzodiazepine will be asked to convert from their current benzodiazepine to an equivalent dose of Lorazepam (2mg or less in 24 hours). This will be administered in pill form.
16066585|NCT02407691|Other|Primary care 101 plus mental health|A facility-based stepped care intervention combining depression case detection by non-physician clinicians with group counselling intervention delivered by lay-health workers.
16066586|NCT02407691|Other|Standard Primary Care 101|Standard Primary Care 101 guideline with standard training
16066587|NCT02407678|Genetic|AAV-mediated REP1 gene replacement|AAV vector carrying human REP1 gene is delivered into the treated eye by subretinal injection
16066588|NCT02407665|Behavioral|Tai Chi|Each Tai Chi session will last 60 minutes and will continue twice a week for 12 weeks. Our instructors, who have extensive experience conducting Tai Chi training programs, will follow the standardized Tai Chi protocol. We will also provide the participants with printed materials on FM and the Tai Chi Mind-Body program, including Tai Chi principles, practicing techniques, and safety precautions for participants with FM
16066589|NCT02407652|Behavioral|Cognitive Control Training|10 adaptive Paced Auditory Serial Addition Task (PASAT) sessions, 400 trials each
16066591|NCT02407639|Other|CO2|gas
16066592|NCT02407639|Other|air|air
16066595|NCT02407613|Device|Philips Sonalleve MR-HIFU Breast Tumor Therapy System|Magnetic Resonance-guided High-Intensity Focused Ultrasound (MR-HIFU) is a completely non-invasive treatment technique. HIFU uses focused ultrasound to achieve temperature rise in the targeted tissue. Real time monitoring of the treatment with MR-thermometry is used to ensure optimal safety.
16066596|NCT02407600|Drug|FOSAPREPITANT (Emend)|Uee of fosprepitant in EITHER first OR 2nd cycle of carboplatin containing combination chemotherapy in patients with advanced NSCLC
16066597|NCT02407600|Drug|Placebo|
16066598|NCT02407587|Device|cochlear implants|"PET scans for the mature patients with unilateral cochlear implants and preserved hearing
~4 states and each state will be repeated 3 times Cochlear implant only Residual hearing only Combination of implant and residual hearing No auditory stimulation"
16066599|NCT02407574|Device|External Pacing Box|Atrial pacing using an external pacing box
16066600|NCT02407548|Dietary Supplement|coenzyme Q10 vitamin E softgel|4 coenzyme Q10 and vitamin E softgels per day for 24 weeks. Keep normal lift style unchanged.
16066601|NCT02407548|Dietary Supplement|coenzyme Q10 softgel|4 coenzyme Q10 softgels per day for 24 weeks. Keep normal lift style unchanged.
16066602|NCT02407548|Dietary Supplement|placebo softgel|4 placebo softgels per day. Keep normal lift style unchanged.
16066603|NCT02407535|Device|Intraoperative ultrasound|Diagnostic intraoperative ultrasound in the uterus after hysterectomy for assessing depth of tumor invasion
16066604|NCT02407522|Dietary Supplement|Black rice|They asked to keep their normal life style during intervention
16066605|NCT02407522|Other|follow-up|They asked not to consume any black rice or excess amount of food rich in anthocyanin compared to their normal life style, such as grapes, blueberry, red wine, black bean during intervention.
16066606|NCT02407509|Drug|RO5126766|
16066607|NCT02407509|Drug|Everolimus|
16066608|NCT02407496|Other|Behavioral assessment and NAT EEG tests|Individuals in both groups are asked to perform standard behavioral tests and an electroencephalography (EEG) test.
16066609|NCT02407483|Device|Laser Visual Guidance|Laparoscopic simulator training, tested with laser visual guidance
16066610|NCT02407483|Device|2 D vision|Laparoscopic simulator training, tested without laser visual guidance
16066611|NCT02407470|Drug|Rabbit antithymoglobulin (ATG)|Rabbit ATG at 3.5 mg/kg/dose IV is given from day -6 to -2.
16066612|NCT02407470|Procedure|Adipose derived mesenchymal stem cells ( AD-MSCs)|Participants will receive rabbit ATG at 3.5 mg/kg/dose IV from day -6 to -2, and then patient's own AD-MSCs at a dose of 3000000 cells/kg/d on day 1-3.
16066613|NCT02407470|Procedure|AD-MSC transdifferentiated HSCs (AD-HSCs)|Participants will receive rabbit anti-thymocyte globulin at 3.5 mg/kg/dose IV from day -6 to -2, and then patient's own AD-HSCs at a dose of 3000000 cells/kg/d from day 1 to 4.
16066614|NCT02407457|Device|AFX EVAR AAA Graft System|Endvovascular Abdominal Aneurysm Repair (EVAR) using commerically available, FDA approved endovascular graft systems implanted via femoral access.
16066615|NCT02407457|Device|FDA Approved EVAR AAA Graft Systems|
16066616|NCT02407444|Other|Physiotherapy treatment & leg cycling|"All patients receive comprehensive care as part of routine rehabilitation program : individual physical therapy treatment, gym's training and balance training in virtual reality, occupational therapy treatment, strengthening and range of motion exercises as a group.
~In addition each patient in this group will train with stationary leg cycle ergometer for 20 minutes under physical therapist's supervision . Cycling exercise intensity subjectively determined by the patient using RPE Borg scale . Maximal intensity level determined as 14 in Borg scale."
16066617|NCT02407444|Other|Physiotherapy treatment & music listening|"All patients receive comprehensive care as part of routine rehabilitation program : individual physical therapy treatment, gym's training and balance training in virtual reality, occupational therapy treatment, strengthening and range of motion exercises as a group.
~In addition each patient in this group will listen to music with earphone for 20 minutes while sitting under physical therapist supervision.
~Overall treatment session will last 50 minutes."
16066618|NCT02407418|Other|Spinal Manipulation|Side-posture, high-velocity low-amplitude spinal manipulation targeting the lumbar spine and sacroiliac joints
16066619|NCT02407418|Other|Sham Manipulation|A simulated lumbar spine manipulation in which no vertebral contact was made
16066620|NCT02407405|Drug|Selumetinib|orally 50 mg/dose, every 12 hours every day continuously (1 cycle = 28 days)
16066621|NCT02407392|Drug|Acetic Acid|During endoscopy Acetic acid will be sprayed onto Barrett's oesophagus and targeted biopsies of taken.
16066622|NCT02407392|Procedure|Non targeted quadrantic biopsies|During endoscopy patients will undergo current standard quadrantic Seattle protocol biopsies of Barrett's oesophagus
16066623|NCT02407379|Procedure|PAPD+SRP|Photoablation of the gingival epithelium was performed with at 810 nm diode laser (1 W output power, continuous wave mode, 66.7 J/cm2, a 0.6 mm optical fiber). SRP was performed using curettes. The periodontal tissues and the dental root were rinsed with the photosensitizer agent methylene blue (0.3% w/v in water). After 5 min., the treated areas were irradiated with at 635 nm diode laser (100 mW output power, continuous wave mode, 0.6 mm optic fiber). The photodynamic treatment was repeated once weekly until normalization of the cytodiagnostic parameters (range: 4-10 applications).
16066624|NCT02407379|Procedure|Sham-laser +SRP|Sham-treatment was similar to the previously described treatment but with switched off laser, followed by scaling and root planing
16066625|NCT02407366|Drug|Icotinib|Icotinib (125 mg ,Three times daily)
16066626|NCT02407366|Drug|Pemetrexed|Pemetrexed(500mg/m2)every 21 days
16066627|NCT02407366|Drug|Carboplatin|Carboplatin (AUC，5) every 21 days
16066628|NCT02407366|Radiation|Thoracic radiotherapy(TRT)|TRT (total dose 66Gy, 2Gy per time, once a day, five times a week, a total of 33 times)
16066629|NCT02407353|Drug|PF-06648671|Experimental Pfizer compound which will be dosed as oral suspension, single dose at 300 mg and/or 1-2 lower doses
16066630|NCT02407353|Drug|Placebo|Placebo which will be dosed as oral suspension, single doses to match PF-06648671
16066631|NCT02407340|Drug|oxytocin|40 international Units (IU) 3xday delivered as 5 sprays (0.1 mL) per nostril
16066632|NCT02407340|Drug|placebo|5 sprays (0.1 mL) per nostril 3xday; bottles are identical to those of active drug
16066633|NCT02407314|Procedure|Percutaneous Peripheral Intervention|Percutaneous peripheral intervention is a common procedure performed by cardiologists to revascularize peripheral arterial lesions in patients (stent placement). This procedure is considered standard of care and is not experimental.
16066634|NCT02407314|Device|Optical Coherence Tomography|This is an established medical imaging technique that uses light to capture micrometer-resolution, three-dimensional images from within optical scattering media. The device used is a cardiac catheter with OCT sensors on the tip of it. It will be used to assess the artery vessels after Percutaneous Peripheral Intervention.
16066635|NCT02407314|Other|Ankle Brachial Index|This a clinical assessment and consists of the calculation of the ratio of the blood pressure in the lower legs to the blood pressure in the arms. The ABI is calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressures in the arm.
16066636|NCT02407314|Other|Six minute walk distance|Assessment of the walking distance in 6 minutes.
16066637|NCT02407314|Drug|Aspirin|Aspirin, also known as acetylsalicylic acid [ASA], is a salicylate drug, often used as an analgesic to relieve minor aches and pains, as an antipyretic to reduce fever, and as an anti-inflammatory medication. Aspirin also has an antiplatelet effect by inhibiting the production of thromboxane, which under normal circumstances binds platelet molecules together to create a patch over damaged walls of blood vessels.
16066638|NCT02407314|Drug|Aspirin + Ticagrelor|This is a combination of drugs (Aspirin + Ticagrelor). Ticagrelor is a platelet aggregation inhibitor due to its properties as an antagonist of the P2Y12 receptor. Ticagrelor is a nucleoside analogue: the cyclopentane ring is similar to the sugar ribose, and the nitrogen rich aromatic ring system resembles the nucleobase purine, giving the molecule an overall similarity to adenosine.
16066639|NCT02407301|Other|cough airflow measure|Participants will produce multiple voluntary coughs for cough airflow assessment.
16066640|NCT02407301|Other|vocal tasks|The assessment of glottal closure will be performed during phonation tasks.
16066641|NCT02407301|Other|true vocal fold movement|The true vocal fold (TVF) movement in cough will be observed and recorded during cough production.
16066642|NCT02407301|Other|spirometry test|The lung function test will require the participant to perform deep inhalations and forceful exhalations into the flow head of the spirometer during spirometry test.
16066643|NCT02407301|Other|maximum expiratory pressure (MEP)|The assessment of maximum expiratory pressure will require forceful exhalations into a mouthpiece of a manometer during maximum expiratory pressure (MEP) assessment.
16066644|NCT02407288|Device|transcranial dirrect current stimulation|The tDCS device will deliver a direct current of 2mA during 20 minutes. Cathode will be localized in front of the left orbito-frontal on the FP3 point according to the EEG international reference. Anode will be localized in front of the right cerebellum 3 cm below the inion and 1 cm right from the midline
16066645|NCT02407288|Device|Sham tDCS|
16066646|NCT02407275|Other|Biological sample|
16066647|NCT02407262|Dietary Supplement|Black seed oil|
16066648|NCT02407262|Other|Placebo|vegetable oil
16066653|NCT02407223|Drug|Group 1: Placebo|Participants will receive placebo SC at Weeks 0, 4, 16, and 20. At Week 24, all participants (except those who early escaped) will crossover to receive ustekinumab 45 or 90 mg SC at Weeks 24 and 28 followed by every 12 weeks up to Week 52. At Week 16, participants in placebo group with < 10% improvement from baseline in both total back pain and morning stiffness measures at Week 12 and 16 will enter early escape to receive ustekinumab 45 mg or 90 mg at Weeks 16, 20, and 28 followed by every 12 weeks up to Week 52. At Week 52, participants who achieved inactive disease by ASDAS (ESR) <1.3 at both Week 40 and 52 will be re-randomized to receive placebo or ustekinumab every 12 weeks up to Week 88. At Week 52, participants who did not achieve inactive disease by ASDAS (ESR) <1.3 at Week 40 or 52 will continue with ustekinumab every 12 weeks up to Week 88.
16066654|NCT02407223|Drug|Group 2: Ustekinumab 45 mg|Participants will receive ustekinumab 45 mg subcutaneously at Weeks 0 and 4, followed by every 12 weeks through Week 52. At Weeks 20 and 24, participants will receive placebo subcutaneously to maintain the blind. At Week 52, participants who achieved inactive disease by ASDAS (ESR) <1.3 at both Week 40 and Week 52 will be re-randomized to receive either placebo or ustekinumab 45 mg every 12 weeks in a blinded fashion. At Week 52, participants who did not achieve inactive disease by ASDAS (ESR) <1.3 at Week 40 or Week 52 will continue receiving ustekinumab 45 mg every 12 weeks through Week 88.
16066655|NCT02407223|Drug|Group 3: Ustekinumab 90 mg|Participants will receive ustekinumab 90 mg subcutaneously at Weeks 0 and 4, followed by every four weeks through Week 52. At Weeks 20 and 24, participants will receive placebo subcutaneously to maintain the blind. At Week 52, participants who achieved inactive disease by ASDAS (ESR) <1.3 at both Week 40 and Week 52 will receive either placebo or ustekinumab 90 mg every 12 weeks in a blinded fashion. At Week 52, participants who did not achieve inactive disease by ASDAS (ESR) <1.3 at Week 40 or Week 52 will continue receiving ustekinumab 90 mg every 12 weeks through Week 88.
16066656|NCT02407210|Drug|azilsartan|
16066657|NCT02407210|Drug|Olmesartan medoxomil|
16066658|NCT02407184|Other|Newborn exposure to mother vaginal microbiota|Babies are swabbed just after delivery with gauze containing their mother's vaginal microbiota.
16066659|NCT02407171|Drug|MK-3475|200 mg every 2 weeks by IV infusion
16066660|NCT02407171|Radiation|Stereotactic Body Radiation Therapy (SBRT)|The starting dose will be 3000 cGy in 5 fractions; there will be one dose escalation cohort (3000 cGy in 3 fractions), and if necessary one dose de-escalation cohort (1000 cGy in a single fraction).
16066661|NCT02407158|Device|SonarMed Airwave Device|Measure the concordance of chest x-ray and the Airwave device for measuring the change of position of an endotracheal tube.
16066662|NCT02407145|Other|24 month follow up of women with validated questionnaire|24 month follow up (clinical and questionnaire based) of women who are already assigned to have a PVDF retropubic midurethral sling (DynaMesh®-SIS soft) as a part of their planned treatment of urodynamic stress incontinence.
16066663|NCT02407132|Behavioral|Adapted DSME|Participants assigned to this arm received an intervention that includes culturally-adapted DSME with their participating family members in a family/home setting.
16066664|NCT02407132|Behavioral|Standard DSME|Active Comparator: Standard DSME Participants assigned to this arm received standard diabetes self-management education classes offered at community locations, taught by Certified Diabetes Educators (CDEs) in a group/classroom setting.
16066665|NCT02407119|Drug|7 day H.pylori eradication Omeprazole or Rabeprazole, Clarithromycin, Amoxicillin|Omeprazole 20 mg or Rabeprazole 10 mg bid for 7 days, Clarithromycin 500 mg bid for 7 days, Amoxicillin 1,000 mg bid for 7 days.
16066666|NCT02407119|Drug|Placebo, Omeprazole or Rabeprazole, Clarithromycin|Omeprazole 20 mg or Rabeprazole 10 mg bid for 7 days, Placebo for clarithromycin 500 mg bid for 7 days, Placebo for amoxicillin 1,000 mg bid for 7 days.
16066667|NCT02407106|Dietary Supplement|Streptococcus Salivarius BLIS K12|Once daily tablet of BLIS K 12 to be slowly dissolved orally every evening.
16066668|NCT02407093|Behavioral|High-Intensity Functional Training|Constantly varied functional movements performed at a high intensity and incorporating monostructural (aerobic), gymnastics (body weight) and/or weightlifting movements. CrossFit is a good model of HIFT for the military because of its emphasis on general physical preparedness and functional movements and because it is open source and programming is available at no cost (see www.crossfit.com). Sixty-minute HIFT sessions will include a warm-up, workout and cool down. Workouts will average 15 minutes in duration (range = 5-45 minutes) for a total of 50-100 minutes per week.
16066669|NCT02407093|Behavioral|Army Physical Readiness Training|Usual physical training program for Army personnel from directive FM 7-22, using the Reset phase. Exercises will address strength, endurance, and mobility training. APRT is designed to be completed in 60-90 minute sessions, 5 days/week for a total dose of 300-450 minutes per week.
16066670|NCT02407080|Drug|RG7388|RG7388 is supplied as film-coated tablets at dosage strengths of 50 mg, 200 mg, 300mg and 400 mg.
16066671|NCT02407080|Drug|Pegasys|PEGASYS is supplied as a clear, sterile solution for subcutaneous (SQ) injection available in prefilled syringes. weekly doses at 45ug subcutaneously
16066672|NCT02407067|Device|ChatterVox|A voice amplifier will be attached to the participant and used for the treatment of low speech intensity (hypophonia) and reduced speech intelligibility in Parkinson's disease.
16066673|NCT02407067|Device|Easy Listener FM system (Phonic Ear Corp.)|"A personal communication (FM) system will be attached to the participant and used for the treatment of low speech intensity (hypophonia) and reduced speech intelligibility in Parkinson's disease.
~Personal Communication System"
16066674|NCT02407054|Drug|LY3023414|Administered orally
16066675|NCT02407054|Drug|Enzalutamide|Administered orally
16066676|NCT02407054|Drug|Placebo|Administered orally
16066677|NCT02407041|Drug|GR-MD-02|IV infusion
16066678|NCT02407028|Drug|Hyperbaric oxygen (1.5 ATA, no NBH)|HBO at 1.5 ATA for 60 minutes without NBH. Treatment will be twice a day for five days or until patient is following commands or brain dead
16066679|NCT02407028|Drug|Hyperbaric oxygen (2.0 ATA, no NBH)|HBO at 2.0 ATA for 60 minutes without NBH. Treatment will be twice a day for five days or until patient is following commands or brain dead
16066680|NCT02407028|Drug|Hyperbaric oxygen (2.5 ATA, no NBH)|HBO at 2.5 ATA for 60 minutes without NBH. Treatment will be twice a day for five days or until patient is following commands or brain dead
16066681|NCT02407028|Drug|Hyperbaric oxygen (1.5 ATA + NBH)|HBO at 1.5 ATA for 60 minutes followed by NBH for 3 hours. Treatment will be twice a day for five days or until patient is following commands or brain dead
16066682|NCT02407028|Drug|Hyperbaric oxygen (2.0 ATA + NBH)|HBO at 2.0 ATA for 60 minutes followed by NBH for 3 hours. Treatment will be twice a day for five days or until patient is following commands or brain dead
16066683|NCT02407028|Drug|Hyperbaric oxygen (2.5 ATA + NBH)|HBO at 2.5 ATA for 60 minutes followed by NBH for 3 hours. Treatment will be twice a day for five days or until patient is following commands or brain dead
16066684|NCT02407028|Drug|Normobaric Hyperoxia (NBH)|100% fraction of inspired oxygen (FiO2) for 4.5 hours twice a day for five days or until patient following commands or brain dead
16066685|NCT02407028|Other|Usual Care|Will be treated with usual and customary care for severe traumatic brain injury
16066686|NCT02407015|Other|Nintendo 3DS gameplay|
16066687|NCT02406989|Drug|MS-553|Study Drug
16066688|NCT02406989|Drug|Placebo|Matching placebo to MS-553
16066689|NCT02406976|Other|G1 -Exercise|"20 minutes of aerobic exercises of low intensity (2-4 on the Borg scale) in the rhythm of different songs that encourage their implementation. After these exercises will be performed five minutes of stretching exercises.
~Furthermore the similar treatment to G3."
16066690|NCT02406976|Behavioral|G2- Exercise and Lifestyle|"Exercise more techniques of cognitive behavioral therapy based on principles of learning, in order to promote and maintain new healthy behaviors and the reduction or elimination of undesirable conduct.
~Furthermore the similar treatment to G3."
16066691|NCT02406976|Other|G3- Control|Routine treatment in outpatient of bariatric surgery. Consists of individual consultations and 05 (five) information meetings organized by the multidisciplinary team composed by the surgeon, endocrinologist, psychologist, psychiatrist, nutritionist, physical education teacher, pulmonologist, cardiologist and nurse. The G1 and G2 will also receive this intervention.
16066692|NCT02406963|Other|Digital Photograph|A digital photograph sent by the family of the surgical site
16066693|NCT02406963|Other|Telephone Call|Standard telephone call with the nurse practitioner
16066694|NCT02406950|Drug|Sitagliptin|The brachial FMD before and after IR injury will be assessed. After randomization, study medication will be treated. In 2 hours later, the brachial FMD before and after IR injury will be assessed again. All volunteers had a wash-out period of 7 days. Seven days later, the subjects returned to crossover study medication (ie, sitagliptin or placebo), and the protocol described above was repeated.
16066695|NCT02406937|Dietary Supplement|Oral intake of Feihe New Formula|Oral intake of Feihe New Formula
16066696|NCT02406937|Dietary Supplement|Oral intake of Feihe Stage 1 Formula|Oral intake of Feihe Stage 1 Formula
16066697|NCT02406937|Dietary Supplement|Breast Feeding|Oral intake of breast milk
16066698|NCT02406924|Procedure|Biopsy|A cylinder of grafted bone will be removed from the location elected for the implant installation with an appropriate trephine
16066699|NCT02406924|Radiation|Computerized Tomography|An initial computerized tomography will be made before the first surgery, and a final computerized tomography will be made after 9 months, previously to the second surgery
16066700|NCT02406924|Other|Standardized periapical radiographs|A device will be adopted for the standardization, and radiographs will be taken at day 0, 3 months, 6 months, 12 months, 18 months, 24 months after implant installation
16066912|NCT02405416|Procedure|Selective hepatic vascular exclusion|Selected major hepatic vein is clamped in hepatectomy.
16066701|NCT02406924|Other|Intraoral scanning|Intraoral scanning will be made before the graft, at implant installation, 3 months, 6 months, 12 months, 18 months, 24 months after implant installation
16066702|NCT02406911|Drug|Ticagrelor|After randomization, each group will be treated as assigned dose of ticagrelor (ticagrelor 90mg once a day or 90mg twice a day) for 14 days. After 1 week wash-out period, cross-over study will be performed
16066703|NCT02406898|Device|morcellator uterine system (MH)Karl Storz, Tuttligen- Germany|
16066704|NCT02406885|Drug|Apixaban|New Oral Anticoagulants (NOACs) are currently available for prophylaxis against venous thromboembolism in patients undergoing total hip or knee replacement surgery.
16066705|NCT02406872|Drug|Remimazolam Tosilate|IV pumping for anesthesia
16066706|NCT02406872|Drug|Propofol|IV bolus for anesthesia
16066707|NCT02406859|Behavioral|Bowel Biofeedback|Subjects will complete 2 sessions twice a week for 6 weeks of bowel biofeedback training. Subjects will be asked to squeeze and bear down for a period of 5 seconds followed by rest for 10seconds. Following the training, each subject will complete similar training at home for 6 weeks.
16066708|NCT02406859|Behavioral|Anorectal Manometry|Subjects will undergo an anorectal manometry to establish baseline pressure characteristics. If subjects qualify for biofeedback training, they will complete two additional manometries to track the changes occuring during training.
16066709|NCT02406846|Other|Flow cytometry (FCM)|Use FCM to test PBMCs/CTCs from volunteers/patients.
16066710|NCT02406846|Other|RT-PCR|Use RT-PCR to test PBMCs/CTCs from volunteers/patients.
16066711|NCT02406833|Drug|TGF-β2 antisense oligonucleotide|intravitreal injection
16066712|NCT02406833|Procedure|Trabeculectomy|Standard trabeculectomy with the use of antimetabolites (mitomycin C) for glaucoma patients with insufficient intraocular pressure (IOP) control
16066713|NCT02406820|Device|Non-invasive hemodynamic monitoring (CVInsight™ [CVI])|
16066714|NCT02406807|Other|HVLA manipulation|participant is laying on the left side, the practitioner stands in front of the participant's abdomen. The practitioner contacts the interspinous space of the L5-S1 level with the caudal; with the cephalic hand, the practitioner rotates the participant's upper body until a sense of tension is palpated at the L5-S1 segment. The practitioner places his cephalic hand at interspinous, brings participant's leg to a flexion and places the foot at the popliteal fossa, places the forearm at the participant's deltopectoral groove and the caudal forearm at the gluteal region. Following the participant's expiration, the practitioner brings the L5-S1 level to the restrictive barrier by rotating the trunk and hips to opposite directions.
16066715|NCT02406807|Other|Sham Spinal lumbar manipulation|Sham manipulation
16066716|NCT02406794|Drug|Neuromuscular taping|The first group will receive a decalogue of healthy tips (general, to lead an active life) based on the best available evidence, and several strips of neuromuscular bandage will be applied on areas that refer pain (cervical, lumbosacral, both or wrist-forearm).
16066717|NCT02406781|Drug|Combination of MK3475 with Metronomic CP|"Combination of MK3475 with Metronomic CP. Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule.
~MK3475 will be administered intraveinously, and given every 3 weeks on day 8. A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation."
16066718|NCT02406781|Drug|Combination of MK3475 with Metronomic CP and G100|"Combination of MK3475 with Metronomic CP and G100. Metronomic CP (cyclophosphamide) will be administered per os bi-daily (50 mg x 2), and given on a week on/ week off schedule.
~MK3475 will be administered intravenously (200 mg), and given every 3 weeks on day 8.
~G100 will be administered by intra-tumoral injection (20µg), one weekly injection for at least 6 weeks and for a maximum of 12 weeks. G100 will start one week before CP administration (impregnation phase).
~A treatment cycle consists of 3 weeks. Treatment may continue until disease progression or study discontinuation."
16066719|NCT02406755|Other|one-sensory self care (Todo Dia®)|daily use of odorless body moisturizer (Todo Dia® - Natura)
16066720|NCT02406755|Other|multisensory self care (Todo Dia®)|daily use of moisturizing body with cotton fragrance (Todo Dia® - Natura) + audiovisual stimulus
16066721|NCT02406755|Other|bi-sensory self care (Todo Dia®)|daily use of moisturizing body with cotton fragrance (Todo Dia® - Natura)
16066722|NCT02406742|Drug|CC-122|CC-122 will be administered daily starting at Cycle 1 Day 1 in 28-day cycles until disease progression, unacceptable toxicity, or discontinuation for any other reason.
16066723|NCT02406742|Drug|Ibrutinib|
16066724|NCT02406742|Drug|Obinutuzumab|Obinutuzumab will be administered as an intravenous (IV) infusion at a dose of 100 mg on Cycle 1 Day 1 and 900 mg on Cycle 1 Day 2 and 1000 mg on Cycle 1 Days 8 and 15. The dose of obinutuzumab on Days 1 and 2 of Cycle 1 may be adjusted per institutional practice as long as the combined dose equals 1000 mg. Obinutuzumab will be administered at a dose of 1000 mg on Day 1 of Cycles 2 through 6.
16066725|NCT02406729|Biological|Dengue 1,2,3,4 (attenuated) vaccine|Dose 1000 PFU per virus (1,2,3,4) Route:subcutaneous
16066726|NCT02406729|Other|Placebo|Route:subcutaneous
16066727|NCT02406716|Other|Biospecimen retention|
16066728|NCT02406703|Drug|Chloroprocaine|
16066729|NCT02406703|Drug|Mepivacaine|
16066730|NCT02406690|Other|Estradiol Valerate, Progesterone in Oil, Leuprolide|Patients will undergo a Leuprolide endometrial preparatory cycle using estradiol valerate, progesterone in oil and once completed will have a uterine aspiration and biopsy performed.
16066731|NCT02406677|Other|Study voucher card|Study voucher card to offset any patient copayments or medication costs for the filling of any prescriptions of clopidogrel or ticagrelor
16066732|NCT02406664|Procedure|Bariatric surgery|Laparoscopic or Robot R-Y gastric bypass
16066733|NCT02406651|Drug|Recombinant Human Interleukin-22 IgG2-Fc (F-652)|IV infusion of reconstitution lyophilized F-652.
16066734|NCT02406651|Drug|Systemic Corticosteroids|Prednisone (or equivalent) at the time of the onset of clinical symptoms consistent with GI and/or liver aGVHD, as per the standard of care. Prednisone (or equivalent) will be given at a dose of 2 mg/kg/day and tapered as needed.
16066735|NCT02406638|Other|3D pelvic floor ultrasound|Pelvic Floor 3D Ultrasound Clinical evaluation with pad-test, stress test and questionnaires of symptoms and quality of life
16066736|NCT02406625|Behavioral|Behavioral Therapy|16 therapeutic group sessions are delivered to both parents and adolescents; according to the assigned group for each family.
16066737|NCT02406612|Device|X-Seal 6F Vascular Closure Device|
16066738|NCT02406599|Device|Margin Probe|The surgeon will use the MarginProbe System to identify cancerous tissue at the margins (≤ 1mm) of the main ex-vivo lumpectomy specimen following primary excision
16066739|NCT02406599|Other|Control: Additional inspection|The surgeon will perform additional inspection and assessment of the margins of the main ex-vivo lumpectomy specimen following primary excision
16066740|NCT02406586|Drug|Salsalate|Salsalate 750 mg
16066741|NCT02406586|Drug|Carvedilol|Carvedilol 3.125 mg
16066742|NCT02406586|Drug|Placebo|One tablet
16066743|NCT02406586|Drug|Intralipid 20%|24-hour infusion of Intralipid 20% solution at 20 mL/h (96 g/24 h)
16066744|NCT02406573|Device|Crest® Sensi-Stop™ Strips|
16066745|NCT02406560|Drug|tafamidis|fasted
16066746|NCT02406560|Drug|tafamidis|high fat meal
16066747|NCT02406560|Drug|tafamidis|
16066748|NCT02406547|Device|NBI|Withdrawal from cecum to sigmoid colon with Narrow Band Imaging (NBI, Evis Exera III, Olympus)
16066749|NCT02406547|Device|WLE|Withdrawal from cecum to sigmoid colon with High Definition White Light Endoscopy (WLE)
16066750|NCT02406534|Behavioral|HRQoL surveys|
16066751|NCT02406521|Drug|Pazopanib|
16066752|NCT02406521|Drug|Sorafenib|
16066753|NCT02406521|Drug|Radium-223|
16066754|NCT02406508|Device|Melphalan/HDS|
16066755|NCT02406508|Drug|Sorafenib|
16066756|NCT02406495|Device|filcon IV 1|contact lens
16066757|NCT02406495|Device|ocufilcon D|contact lens
16066758|NCT02406482|Behavioral|Microfinance intervention (MF)|Six sessions provided three times per week over two weeks by a study team facilitator. The sessions focus on banking services, savings (including how to open an account), budgeting (including development of a household budget), debt management, and financial negotiations, 1:1 matched savings account for women, followed by vocational training: Women assigned to the HIVRR+MF arm decide during their financial literacy sessions which vocational training program in which they would like to be enrolled (24 sessions).
16066759|NCT02406482|Behavioral|HIV risk reduction (HIVRR)|Four sessions delivered twice a week for the first two weeks. Sessions derive from three evidence-based interventions with demonstrated efficacy to reduce drug and sexual HIV-risk behaviors in vulnerable women. Content focuses on basic transmission risk; educating about the risks of alcohol and drug use and how sexual behavior increases HIV risk; male and female condom use; examining the context for sexual risk including male partner sexual risk behavior (e.g. multiple partners) and violence against women; reducing other sexual risks (e.g., mutual masturbation, correct use of lubricants).
16066760|NCT02406469|Dietary Supplement|Oral consumption milk Tetra Pak|Oral consumption of assigned products in the form of Tetra Pak (A1 or A2 milk according to randomization), 250 ml/time, 2 times daily after meal, for a total of 28 days (14 days in each intervention phase).
16066761|NCT02406456|Other|Neurofeedback|
16066762|NCT02406443|Drug|Sitaglitpin|Oral DPP-4 inhibitor, 100 mg tablet administered once daily for 28 days
16066763|NCT02406443|Other|Placebo|Oral tablet (no medicinal ingredients) administered once daily for 28 days
16066764|NCT02406430|Procedure|a combined cataract and ERM surgery|All patients underwent a combined cataract and ERM surgery owing to visual impairment or disabling metamorphopsia. A complete ophthalmological examination was performed before and at 1,6, and 12 months after the surgery, including best corrected visual acuity with Snellen charts converted into the logarithm of the minimum angle of resolution, slit-lamp biomicroscopy, indirect fundus, and macular optical coherence tomography
16066765|NCT02406417|Device|Investigation for pituitary dysfunction by blood tests.|Blood tests for pituitary function (one or more of the following tests: cortisol, LH, FSH, TSH, FT4, testosterone, prolactin) will be added to samples from patients identified as being at high risk from their initial blood results.
16066766|NCT02406417|Device|Dynamic function tests and pituitary imaging|Patients identified as being highly likely to have a pituitary dysfunction from the results of the blood tests for pituitary function added, will be referred to the Endocrine team for further tests in the form of dynamic function tests and pituitary imaging.
16066767|NCT02406404|Behavioral|Incentive spirometer training|The incentive spirometer, a device that can help improve breathing and strengthen inspiratory muscles. First, the subjects exhaled normally, then placed the mouthpiece in their mouth and sealed their lips around the mouthpiece. Then they inhaled slowly and deeply with their lips sealed tightly on the mouthpiece. After they inhaled as deeply as possible, held their breath for at least 3 seconds, and then removed the mouthpiece from their mouth and breathed out normally. Subjects repeated this technique 10-15 times. When they finished 10-15 exercises, they took a deep breath and coughed. The training was performed ten sessions daily, for 4 weeks.
16066768|NCT02406365|Device|Diagnostic imaging aid for one-visit management of cervical lesions|
16066769|NCT02406352|Device|Multispectral Digital Colposcope with probe|"Cervical images will be obtained with the Multispectral Digital Colposcope. Spectroscopic data will be obtained with the probe from eligible patients who provided consent to participate in the study.
~The standard of care for research participants will not change."
16066770|NCT02406339|Device|NMES|Neuromuscular Electrical Stimulation
16066771|NCT02406339|Device|Vascular Occlusion|Restriction of sanguine flow to the lower limbs
16066772|NCT02406313|Other|CTS|Standardized Thermal Cure
16066773|NCT02406313|Other|ETP|Patient Therapeutic Education
16066774|NCT02406300|Procedure|Subarachnoid Anesthesia|
16066775|NCT02406300|Procedure|PNB/GA|
16066776|NCT02406300|Drug|ropivacaine|
16066777|NCT02406300|Drug|sevoflurane or desflurane|
16066778|NCT02406300|Drug|bupivacaine or levobupivacaine|
16066779|NCT02406287|Drug|Netarsudil (AR-13324) Ophthalmic Solution|Topical ophthalmic solution
16066780|NCT02406287|Drug|Netarsudil (AR-13324) Ophthalmic Solution Placebo|Ophthalmic solution once a day
16066825|NCT02406014|Drug|Diclofenac sodium gel 3%|Diclofenac sodium gel 3% Solaraze® applied on the selected treatment area, twice daily for 90 days.
16066826|NCT02406001|Device|Tigran PTG|Open Flap Debridement
16066827|NCT02406001|Procedure|Surgical intervention|Open Flap Debridement
16066828|NCT02405988|Drug|Intravenous naloxone|Administer 2,5 mL, dose intravenous naloxone 1,0 mg
16066913|NCT02405416|Procedure|Portal triad clamping|Portal triad are clamped in hepatectomy.
16066914|NCT02405403|Drug|[18F]DPA-714 PET|[18F]DPA-714 Positron Emission Tomography
16066781|NCT02406274|Other|Contrast Enhanced Spectral Mammography (CESM)|Women presenting to MSKCC with a palpable abnormality within the breast either self palpated & or palpated by their physician will be offered CESM instead of FFDM alone. The breast imager assigned to care for the patient will interpret the low energy images (including any additional views they routinely obtain) & record their findings. They will then interpret the CESM & record those results. As per standard of care, the patient will have a targeted ultrasound as well. Appropriate clinical recommendations will be made. In patients with no specific imaging findings, follow-up will be determined by the degree of suspicion of the palpable finding & will either be called negative & followed clinically if not suspicious, or will go on to MRI , percutaneous biopsy by a surgeon or surgical biopsy if suspicious.
16066782|NCT02406261|Drug|Lanabecestat|50 mg lanabecestat will be administered orally as 1 × 50-mg tablet
16066783|NCT02406261|Drug|Simvastatin|20 mg simvastatin will be administered orally as 1 × 20-mg tablet
16066784|NCT02406261|Drug|Midazolam|500 mcg midazolam will be administered orally as 0.25 mL of 2-mg/mL syrup
16066785|NCT02406261|Drug|Midazolam|250 mcg midazolam will be administered intravenous (IV) as 0.25 mL of 1-mg/mL injection solution
16066786|NCT02406261|Drug|Donepezil|5 mg donepezil will be administered orally as 1 × 5-mg tablet
16066787|NCT02406261|Drug|Lanabecestat|50 mg lanabecestat will be administered orally as 1 × 50-mg tablet
16066788|NCT02406248|Drug|Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)|Ticagrelor 180mg loading dose taken orally, followed by 90mg twice daily (bd)
16066789|NCT02406222|Drug|Pomalidomide|Chemotherapy
16066790|NCT02406222|Drug|Dexamethasone|Chemotherapy
16066791|NCT02406222|Drug|Cyclophosphamide|Chemotherapy
16066792|NCT02406209|Drug|NS2|NS2 ophthalmic drops (0.5%)
16066793|NCT02406209|Drug|Prednisolone acetate ophthalmic suspension (1%)|
16066794|NCT02406183|Radiation|Stereotactic body radiotherapy (SBRT)|The SBRT dose will be escalated in 3 steps as described above and will be given on d39, d41 and d43
16066795|NCT02406183|Drug|Ipilimumab|Ipilimumab 3mg/kg will be given IV on d1, d22, d43 and d64
16066796|NCT02406170|Drug|Regorafenib|The dose of regorafenib will be escalated in fixed increments to establish the maximum tolerated dose (MTD) from day 1-21 against a cytotoxic backbone of paclitaxel 80mg/m2 on days 1, 8 and 15 of a 28 day cycle
16066797|NCT02406170|Drug|Paclitaxel|Paclitaxel will be administered in combination with regorafenib to serve as a cytotoxic backbone, it will be given in a dose of 80mg/m2 on days 1,8 and 15 of a 28 day cycle.
16066798|NCT02406157|Device|577-MPL|Device for 577nm micropulse treatment of the diabetic macular edema with the following parameters:100 microns spot size,5% duty cycle of 0.2 seconds,power is tested on micropulse mode and then reduce power to 50% of visible
16066799|NCT02406157|Device|532-SLP|Device for 532nm subthreshold treatment of the diabetic macular edema, by decomposing a subthreshold short pulse, with 10 milliseconds, 100 microns, and power(100-1000mW) adjusted according to patient's diopter transparency and pigmentation
16066800|NCT02406144|Drug|MLN9708|
16066801|NCT02406144|Drug|Lenalidomide|
16066802|NCT02406144|Drug|Dexamethasone|
16066803|NCT02406131|Other|Remote Ischemic Preconditioning|standard blood pressure cuffs applied to upper limb . The cuff will be inflated to 200 mmHg applied for 5 minutes alternating with 5 minutes rest to the total of 4 cycles
16066804|NCT02406118|Procedure|Transanal total mesorectal excision|Subjects will have their rectal cancer removed using a technique combining surgery through the anus and standard laparoscopy. Transanal visualization will be using endoscopy. At the end of the procedure, the rectum will be removed though the anus or ileostomy formation site, the bowel will be re-connected to the anus, and a temporary diverting stoma will be created, which is standard of care following surgery for this type of cancer.
16066805|NCT02406105|Radiation|Radiosurgical thalamotomy|Cybernetic microradiosurgery based thalamotomy
16066806|NCT02406105|Drug|CyberKnife|
16066807|NCT02406092|Drug|Rituximab|Rituximab SC 1400 mg
16066808|NCT02406092|Drug|Cyclophosphamide|Cyclophosphamide will be administered as per standard local practice.
16066809|NCT02406092|Drug|Doxorubicin|Doxorubicin will be administered as per standard local practice.
16066810|NCT02406092|Drug|Vincristine|Vincristine will be administered as per standard local practice.
16066811|NCT02406092|Drug|Prednisone|Prednisone will be administered as per standard local practice.
16066812|NCT02406092|Drug|Fludarabine|Fludarabine will be administered as per standard local practice.
16066813|NCT02406079|Procedure|tracheotomy|Tracheotomy is one of most performed surgical procedures to assure airway by making a hole in front of the trachea in ICU.
16066814|NCT02406066|Drug|metyrapone & oxazepam|6 subjects will receive active study drug (a low dose combination of metyrapone & oxazepam) and 2 subjects will receive placebo.
16066815|NCT02406066|Drug|metyrapone & oxazepam|6 subjects will receive active study drug (a medium dose combination of metyrapone & oxazepam) and 2 subjects will receive placebo.
16066816|NCT02406066|Drug|metyrapone & oxazepam|6 subjects will receive active study drug (a high dose combination of metyrapone & oxazepam) and 2 subjects will receive placebo.
16066817|NCT02406066|Drug|Placebo|Each cohort will have 2 subjects receiving placebo
16066818|NCT02406053|Genetic|oxidative and antioxidant biomarkers|the oxidative damage in these diseases by evaluating the oxidative and antioxidant biomarkers.
16066819|NCT02406040|Other|Energy Restriction|All meals will be provided for the duration of the energy restriction intervention and the energy deficit will be calculated based on estimated energy requirements by indirect calorimetry to provide 60% of energy requirements. In addition, one leg will be assigned to perform resistance exercise for 5 days during the 10 day energy deficit.
16066820|NCT02406027|Drug|JNJ-54861911, 10 mg|Participants will self-administer JNJ-54861911 tablet, 10 mg (2*5 mg), orally, once daily.
16066821|NCT02406027|Drug|JNJ-54861911, 25 mg|Participants will self-administer 1 tablet of JNJ-54861911, containing 25 mg orally, once daily.
16066822|NCT02406027|Drug|Placebo|Participants will self administer placebo matching to JNJ-54861911 orally once daily.
16066823|NCT02406027|Drug|JNJ-54861911, 5 mg|Participants will self-administer JNJ-54861911 tablet, 5 mg, orally, once daily.
16066824|NCT02406014|Drug|Ingenol Mebutate Gel, 0.015%|Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs.
16066829|NCT02405988|Drug|Remifentanil|Administer remifentanil intravenously by way of Target Control Infusion, Minto's model at a target of 1,3 ng/ml. This to achieve a state of safe and predictable opioid influence to assess pharmacodynamic response to naloxone.
16066830|NCT02405975|Other|SCRIPT|An online tool designed to train doctors in all areas of prescribing
16066831|NCT02405962|Behavioral|ACT|Four sessions of group-based ACT integrated with asthma education. Each session will compose of pediatric asthma education based on guidelines of Global Strategy for Asthma Management and Prevention Revised 2011, plus group-based Acceptance and Commitment Therapy (ACT). The goal of ACT is to enhance the psychological flexibility of the parents, enabling them to (1) become aware of their thoughts and feelings regarding their child's asthma and its management, (2) accept and adapt flexibly to challenging situations, and (3) take actions to achieve valued goals in childhood asthma management.
16066832|NCT02405962|Behavioral|Control|One session of educational talk about pediatric asthma care, as the usual care. To ensure the equivalency of the assigned sessions between groups, after attending the talk in the first week, the parents in the Control group will receive three telephone calls, starting from the second week on a weekly basis. This arrangement can also minimize the interference of the usual care naturalistically available in the study setting.
16066833|NCT02405949|Genetic|Genetic test|Analysis of the main genetic variants associated with obesity are evaluated, mainly those related to the regulation of appetite, energy expenditure, adipogenesis, diabetes, inflammation of adipose tissue and others .
16066834|NCT02405936|Procedure|Gynecologic surgery|The researchers prospectively will collect data on all patients undergoing gynecologic surgery at Kangbuk Samsung Hospital since March, 2015.
16066835|NCT02405923|Other|HRF|The subject will take the formula for a period of 12 months.
16066836|NCT02405923|Other|eHF|The subject will take the formula for a period of 12 months.
16066837|NCT02405910|Drug|Nab-paclitaxel|
16066838|NCT02405910|Drug|Gemcitabine|
16066839|NCT02405897|Device|Cup forceps|In patients with sarcoidosis, flexible bronchoscopy and transbronchial lung biopsy using cup forceps
16066840|NCT02405897|Device|Alligator forceps|In patients with sarcoidosis, flexible bronchoscopy and transbronchial lung biopsy using alligator forceps
16066841|NCT02405884|Other|Kowa HA-2 Perkins applanation tonometer.|Patients were divided into groups according to the days on which they underwent hemodialysis. Intraocular pressure was measured with a Kowa HA-2 Perkins applanation tonometer. The tonometry included three measurements in the central region of the cornea before and after hemodialysis. In all patients, the measurements were performed three times on the days when hemodialysis sessions were performed, with 24 hours between each session, and the means of the measurements were obtained. All parameters were measured under prior corneal anesthesia with 0.1% proparacaine and 0.25% fluorescein eye drops.
16066842|NCT02405858|Drug|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) (four 250 mg tablets) orally once daily up to Cycle 26.
16066843|NCT02405858|Drug|Prednisolone|Oral prednisolone 5 mg will be concomitantly administered twice a day (10 mg/day) up to Cycle 26.
16066844|NCT02405845|Radiation|Computed Tomographic Angiogram|1 additional non-clinical CTA per patient enrolled in the study. The estimated radiation risk from a single CTA of the neck and brain is approximately 3.6 millisieverts (mSv), an exposure similar to a single airplane flight across Canada.
16066845|NCT02405832|Dietary Supplement|Zinc|Oral administration of a 40 mg elemental zinc (in the form of zinc sulfate) lozenge, with sweetener and citrus flavor
16066846|NCT02405832|Dietary Supplement|Placebo|Placebo lozenge, with sweetener and citrus flavor, administered orally
16066847|NCT02405819|Other|'My Care Plan'|'My Care Plan' is a patient-initiated survivorship care planning tool.
16066848|NCT02405819|Other|'Survivorship Care Plan Builder'|'Survivorship Care Plan Builder' is a provider-initiated survivorship care planning tool.
16066849|NCT02405806|Dietary Supplement|low carbohydrate food|low carbohydrate food
16066850|NCT02405806|Dietary Supplement|standard food|standard food
16066851|NCT02405793|Drug|Meloxicam Test Capsules|
16066852|NCT02405793|Drug|Meloxicam Test Capsules|
16066853|NCT02405793|Drug|Meloxicam Tablets|
16066854|NCT02405780|Drug|FKB327|Solution of FKB327 for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 28 weeks. Patients may continue to receive FKB327 40 mg every other week by subcutaneous injection for up to 76 weeks.
16066855|NCT02405780|Drug|Humira®|Solution of Humira® for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 28 weeks. Patients may then receive FKB327 40 mg every other week by subcutaneous injection from week 30 to week 76.
16066856|NCT02405767|Other|Foot ulcer impedance|lmpedence measured using ECG electrodes placed at the periphery of the wound (when the wound dressing is changed as part of standard care).
16066857|NCT02405754|Diagnostic Test|Corus CAD (ASGES)|Age/Sex/Gene Expression Score - ASGES
16066858|NCT02405741|Device|Hyperbaric chamber treatment|
16066859|NCT02405728|Device|Centrally inserted central catheters (CICCs)|Randomization between two well established clinical routine vascular access devices
16066860|NCT02405728|Device|Peripherally inserted central catheters (PICCs)|Randomization between two well established clinical routine vascular access devices
16066861|NCT02405715|Drug|Oxytocin nasal spray or placebo|
16066862|NCT02405702|Other|restrospective study|
16066863|NCT02405689|Drug|Remifentanil|
16066864|NCT02405689|Drug|Dexmedetomidine|
16066865|NCT02405689|Drug|Sevoflurane|
16066866|NCT02405676|Drug|Prednisone,Vincristine, Cyclophosphamide|Prednisone 45mg/m2, D1~7; Vincristine 1.5mg/m2(MAX 2mg), D1; Cyclophosphamide 300mg/m2, D1; Intrathecal injection, D1;
16066867|NCT02405676|Drug|Cyclophosphamide, Vincristine, Cytarabine, Doxorubincin, Prednisone|Cyclophosphamide 800mg/m2, D1, then 200mg/m2, D2~4;Vincristine 1.5mg/m2 (MAX 2mg), D1; Cytarabine 1g/m2/dose, (2 doses, 12-hour interval), D4;Doxorubincin 20mg/m2, D2,3; Prednisone 60mg/m2, D1~7;Intrathecal injection, D1,8;
16066868|NCT02405676|Drug|Ifosphamide, Etoposide, Methotrexate, Vincristine, Prednisone|Ifosphamide 1.2g/m2, D1~5; Etoposide, 60mg/m2, D3~5; Methotrexate, 0.5g/m2, D1;Vincristine 1.5mg/m2 (MAX 2mg), D1; Prednisone 60mg/m2, D1~7;Intrathecal injection, D1;
16066869|NCT02405676|Drug|Cyclophosphamide, Vindelsine, Cytarabine, Doxorubincin, Prednisone|Cyclophosphamide 800mg/m2, D1, then 200mg/m2, D2~4;Vindelsine 3mg/m2 (MAX 5mg), D1; Cytarabine 2g/m2/dose, (2 doses, 12-hour interval), D4;Doxorubincin 20mg/m2, D2,3; Prednisone 60mg/m2, D1~7;Intrathecal injection, D1,8;
16066870|NCT02405676|Drug|Ifosphamide, Etoposide, Methotrexate, Vindelsine, Prednisone|Ifosphamide 1.2g/m2, D1~5; Etoposide, 100mg/m2, D3~5; Methotrexate, 5g/m2, D1;Vindelsine 3mg/m2 (MAX 5mg), D1; Prednisone 60mg/m2, D1~7;Intrathecal injection, D1,8;
16066871|NCT02405676|Drug|Rituximab|375mg/m2, 4 injections for patients in Risk group4; D0 of Protocol AA or BB;
16066872|NCT02405663|Procedure|manual removal|one of the standard procedures for placental delivery during caesarean section the surgeon will introduce his hand into the uterine cavity to cleave the placenta from the decidua basalis as soon as possible after the delivery of the baby
16066873|NCT02405663|Procedure|cord traction|one of the standard procedures for placental delivery during caesarean section the surgeon do external uterine massage and gentle traction on the exposed umbilical cord to facilitate placental delivery
16066874|NCT02405637|Drug|simulated amniotic fluid 20cc/kg/day enterally|simulated amniotic fluid 20cc/kg/day enterally for a maximum of 7 days.
16066875|NCT02405637|Drug|distilled water|distilled water 20 ml/kg/day for maximum of 7 days.
16066876|NCT02405624|Procedure|continuous positive airway pressure|CPAP training for muscle strength
16066877|NCT02405611|Behavioral|behavioral|The intervention package contains behavior change techniques targeting outcome expectancy, self-efficacy, action planning, coping planning, and self-monitoring. The active control group receives an information sheet regarding recommendations on fruit and vegetable intake. There will be 3 assessment points in time, with 1 month and six months in between. All the intervention materials and information sheets will be handed to participants after the baseline assessment. The self-monitoring calendar will be collected at time 2 assessment.
16066878|NCT02405611|Behavioral|behavioral|The intervention package contains behavior change techniques targeting outcome expectancy, self-efficacy, action planning, coping planning, and self-monitoring. The active control group receives an information sheet regarding recommendations on fruit and vegetable intake. There will be 3 assessment points in time, with 1 month and six months in between. All the intervention materials and information sheets will be handed to participants after the baseline assessment. The self-monitoring calendar will be collected at time 2 assessment.
16066879|NCT02405611|Behavioral|primary eduction|The intervention package contains behavior change techniques targeting outcome expectancy, self-efficacy, action planning, coping planning, and self-monitoring. The active control group receives an information sheet regarding recommendations on fruit and vegetable intake. There will be 3 assessment points in time, with 1 1 month and six months in between. All the intervention materials and information sheets will be handed to participants after the baseline assessment. The self-monitoring calendar will be collected at time 2 assessment.
16066880|NCT02405598|Drug|Salbutamol|"Albuterol Syrup (1mL= Salbutamol 0.4mg, 60ml/bot)
~VENTOLIN TABLETS 2MG (SALBUTAMOL SULPHATE)"
16066881|NCT02405585|Drug|mFOLFIRINOX|mFOLFIRINOX consisting of Oxaliplatin 85 mg/m^2 IV over 2 hours; Irinotecan 180 mg/m^2 IV over 90 minutes; Leucovorin 400 mg/m^2 IV over 2 hours; Fluorouracil 2.4 g/m^2 IV over 46 hours - given on days 15, 29, 43, 57, 71 and 85
16066882|NCT02405585|Biological|Algenpantucel-L Immunotherapy|HAPa1 and HAPa2 immunotherapy components Algenpantucel-L Immunotherapy (HAPa) consisting of 300 Million HAPa cells given by intradermal injection for up to 28 doses total.
16066883|NCT02405585|Radiation|SBRT|Subjects that have at least stable disease at evaluation (day 93-100) are eligible to receive SBRT radiation given at 1.8 Gy per fraction for 28 fractions for a total dose of 50.4 Gy.
16066884|NCT02405585|Drug|Gemcitabine|"Gemcitabine 1000 mg/m^2 given intravenously over 30 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest.
~Given as adjuvant treatment (days 1, 8 and 15) with 1 week rest for 6 cycles after surgical resection."
16066885|NCT02405572|Other|infant formula|infant formulas
16066886|NCT02405559|Drug|Indocyanine Green|Intradermal injection of Indocyanine Green in the first interdigital space of the studied leg
16066887|NCT02405546|Other|Pre-Rotated (Group R)|In group R, placement of ETT over the FOS was done with 90° CCR from the beginning so that the bevel of the ETT faced posteriorly before it was advanced through the larynx.
16066888|NCT02405546|Other|No pre-rotation|ETT was not pre-rotated but rotated only if necessary
16066889|NCT02405533|Dietary Supplement|AHCC 3 grams once a day|AHCC supplementation x 6 months with Placebo x 6 months
16066890|NCT02405533|Other|Placebo|Placebo supplementation x 12 months
16066891|NCT02405520|Biological|low dosage HPV Vaccine|Participants would intramuscularly receive low dosage of HPV 6/11 bivalent vaccine at 0, 1, 6 month for 3 doses.
16066892|NCT02405520|Biological|medium dosage HPV Vaccine|Participants would intramuscularly receive medium dosage of HPV 6/11 bivalent vaccine at 0, 1, 6 month for 3 doses.
16066893|NCT02405520|Biological|high dosage HPV Vaccine|Participants would intramuscularly receive high dosage of HPV 6/11 bivalent vaccine at 0, 1, 6 month for 3 doses.
16066894|NCT02405520|Biological|Aluminium Adjuvant|Participants would intramuscularly receive aluminium adjuvant at 0, 1, 6 month for 3 doses.
16066895|NCT02405507|Dietary Supplement|wheat bread with wheat germ|
16066896|NCT02405507|Dietary Supplement|wheat bread without wheat germ|
16066897|NCT02405494|Dietary Supplement|Beverage 1|
16066898|NCT02405494|Dietary Supplement|Beverage 2|
16066899|NCT02405494|Dietary Supplement|Beverage 3|
16066900|NCT02405494|Dietary Supplement|Beverage 4|
16066901|NCT02405494|Dietary Supplement|Beverage 5|
16066902|NCT02405494|Dietary Supplement|Beverage 6|
16066903|NCT02405494|Dietary Supplement|Beverage 7|
16066904|NCT02405494|Dietary Supplement|Beverage 8|
16066905|NCT02405494|Dietary Supplement|Beverage 9|
16066906|NCT02405481|Behavioral|SEPA III|
16066907|NCT02405455|Procedure|Cerclage|Surgical procedure which consists of a strong suture being inserted into and around the cervix to close it.
16066908|NCT02405455|Device|Cervical pessary|The Arabin cervical pessary, which is CE-certified for preventing spontaneous preterm birth (CE 0482 / EN ISO 13485: 2003 annex III of the council directive 93/42 EEC). It is a vaginal device which is used to treat pregnant women for preventing spontaneous preterm birth. This device can be easily placed around the uterine cervix without pain.
16066909|NCT02405442|Drug|Andecaliximab|Andecaliximab administered via subcutaneous (SC) injection
16066910|NCT02405442|Drug|Placebo|Placebo to match andecaliximab administered via SC injection
16066911|NCT02405416|Procedure|Infrahepatic inferior vena cava clamping|Infrahepatic inferior vena cava is clamped in hepatectomy.
16066915|NCT02405390|Procedure|Video Laryngoscopy|Head motion will be measured by using Polhemus Patriot™ electromagnetic tracking system
16066916|NCT02405390|Procedure|Direct Laryngoscopy|Time for intubation will be measured from the laryngoscope entering the mouth to the endotracheal tube passing through the vocal cords
16066917|NCT02405390|Device|Storz C-Mac® laryngoscope|
16066918|NCT02405377|Procedure|hydration|Before the coronary procedures, investigators used the same 0.9% sodium chloride for hydration in all patients. Investigator monitored the central venous pressure (CVP) by placing an 5-French catheter in the jugular vein in the intervention group, and administration fluid rate was adjusted according to the CVP as follows: 3 ml/kg/h for CVP lower than 6 mmHg, 1.5 ml/kg/h for pressure of 6-12 mmHg, and 1ml/kg/h for pressure higher than 12 mmHg. The control group was hydrated with 0.9% sodium chloride at 1 ml/kg/h, continued for the duration of 12 h post-procedure in both groups. Thus, both study groups received intravenous fluids for the same duration but at different rates. All study participants received intra-arterial Visipaque(320 mg I/ml; GE Healthcare) iso-osmolar contrast medium.
16066919|NCT02405377|Drug|Visipaque|All study participants received intra-arterial (320 mg I/ml; GE Healthcare)
16066920|NCT02405377|Drug|0.9% sodium chloride ﬂuid administration|
16066921|NCT02405377|Device|5-French catheter|
16066922|NCT02405364|Drug|Carfilzomib/Lenalidomide/Dexamethasone|Induction:Carfilzomib/Lenalidomide/Dexamethasone (4 cycles every 28 days) Stem Cell harvest: HD Cyclophosphamide Intensification: HD Melphalan Consolidation:Carfilzomib/Lenalidomide/Dexamethasone (4 cycles every 28 days) Maintenance: Lenalidomide (13 cycles)
16066923|NCT02405351|Behavioral|Adaptive Working Memory Training|"The working memory training task will consist of an online adaptive working memory program that will test and extend patients' working memory capacity.
~Adaptive refers to the increase in the number of items that the patient is required to remember."
16066924|NCT02405338|Biological|WT1/PRAME vaccination|
16066925|NCT02405325|Behavioral|Physical Activity|intervention activities will remain at the daily level, including using pedometers, having daily goals, attendance at Peer lead group walks and recognition of efforts through monthly celebrations and bi-weekly goal tracking with peer Health Coaches.
16066926|NCT02405312|Behavioral|advance care planning|patient and family meeting with dialysis social worker and nephrologist with discussion of advance care planning and hospice resources
16066927|NCT02405299|Other|experimental groupe|exercices of cognitive and neuropsychological stimulation of inhibition (paper and pencil exercises and computerized exercises) created for the experience: cognitive stimulation exercises for children in the form of cognitive and metacognitive games with rehabilitation objective disorder of inhibition
16066928|NCT02405286|Other|Upper gastrointestinal endoscopy|Upper gastrointestinal endoscopy, if stigmata of recent hemorrhage are seen, varices are either injected with ethanolamine or banded, depending on the clinical setting and availability .
16066929|NCT02405273|Procedure|Pulmonary Rehabilitation|The Intervention Group (IG) will receive an overall rehabilitation treatment based on 10 sessions of pre-operative outpatient PR, early inpatient post-operative PR, and long-term exercise beginning 1 month after surgery and lasting for 15 sessions
16066930|NCT02405273|Procedure|Standard care|Control Group (CG) will receive Standard Care (SC) based upon physiatrist counselling the day before surgery and early inpatient post-operative PR.
16066931|NCT02405260|Drug|TTP399 400 mg|once daily
16066932|NCT02405260|Drug|TTP399 800 mg|once daily
16066933|NCT02405260|Drug|Sitagliptin 100 mg|once daily
16066934|NCT02405260|Drug|Placebo|once daily
16066935|NCT02405247|Other|Patient Reported Outcome (PRO)|Exposure to Quality of Life Questionnaires (EORTC QLQ-LC13, EORTC QLQ-C30 and EQ-5D-5L) every 3 months during standard of care visits.
16066936|NCT02405234|Device|Carbon Modular Radial Head replacement|'Carbon Modular Radial Head replacement: The Ascension Radial Head is made of pyrocarbon, a material that testing has shown to be both wear resistant and biocompatible and has been used in surgical implants for years. The introduction of the pyrocarbon head should alleviate the problems associated with wear debris and fragmentation experienced with the silicone radial spacer.
16066937|NCT02405234|Device|Metal Radial Head replacement|Metal Radial Head replacement:The Ascension® Modular Radial Head (MRH) is an anatomically designed, single-use, modular prosthesis designed for replacement of the proximal end of the radius. FDA cleared this device for commercial distribution under 510(k) K032686. It is made from medical grade cobalt chromium alloy meeting ASTM F1537. Head components are available in six sizes and stem components are available in four sizes are interchangeable and assembled with a taper connection.
16066938|NCT02405221|Biological|TA-CIN (arm)|TA-CIN vaccine 100µg IM in the arm at Week 1, 5, and 9.
16066939|NCT02405221|Biological|TA-CIN (thigh)|TA-CIN vaccine 100µg IM in the arm at Week 1, 5, and 9.
16066940|NCT02405208|Device|PyroTITAN HRA|Humeral resurfacing using the PyroTITAN HRA device
16066941|NCT02405195|Procedure|cardiopulmonary bypass|During cardiac surgery, the subjects are routinely undergoing cardiopulmonary bypass
16066942|NCT02405182|Other|Magnetic Resonance Imaging|
16066943|NCT02405169|Device|4 vs 6 implant treatment in the maxilla|
16066944|NCT02405156|Drug|Letrozole|
16066945|NCT02405156|Drug|Placebo|
16066946|NCT02405156|Drug|Misoprostol|
16066947|NCT02405143|Device|Active tACS using DC-Stimulator MC|Transcranial alternating current stimulation (tACS) is administered using DC-Stimulator MC (NeuroConn GmbH, Ilmenau Germany). Stimulation is administered through two 5 cm2 saline-soaked electrodes placed in the Fpz position and on the right arm. Stimulation will consist of short blocks, during which stimulation frequency will be ramped up to 30Hz with maximum current of 1.5mA. Stimulation will be administered for 20 minutes on 10 consecutive weekdays.
16066948|NCT02405143|Device|Sham stimulation using DC-Stimulator MC|Patients in the sham group will undergo the same preparations as the treatment group. This includes using an identical electrode placement and session duration as for the experimental arm. In order to create the effect of phosphenes, one 5Hz current burst per minute will be administered using the individual phosphene threshold of the patient. This is not expected to have therapeutic effects.
16066949|NCT02405130|Other|intracoronary epinephrine|after failure of standard therapy patients will treated with epinephrine
16066950|NCT02405130|Other|no intracoronary epinephrine|patients will receive standard therapy only
16066994|NCT02404779|Drug|cisatracurium besilate|
16066995|NCT02404779|Other|Placebo|
16066951|NCT02405117|Behavioral|LiveWell System|For 16 weeks, participants will be asked to carry a mobile phone and wear a wrist-worn device for measuring activity. Participants in this arm will receive the psychosocial intervention via a smartphone and context-dependent feedback based on self-report and behavioral data. Providers whose patients are randomized to this arm will also be asked to enroll in order to receive information and notifications about patient status for the duration of the study
16066952|NCT02405104|Drug|chlorzoxazone|ATC-code: M03BB03
16066953|NCT02405104|Drug|Placebo|Placebo
16066954|NCT02405104|Procedure|THA|Surgical treatment of osteoarthrosis in the hip, by replacement.
16066955|NCT02405104|Procedure|TKA|Surgical treatment of osteoarthrosis in the knee, by replacement.
16066956|NCT02405091|Drug|NBI-98854|
16066957|NCT02405078|Drug|Chemotherapy|Given standard salvage chemotherapy
16066958|NCT02405078|Procedure|Computed Tomography|Undergo FDG-PET/CT scan
16066959|NCT02405078|Drug|Fludeoxyglucose F-18|Undergo FDG-PET/CT scan
16066960|NCT02405078|Procedure|Positron Emission Tomography|Undergo FDG-PET/CT scan
16066961|NCT02405065|Drug|HM95573|BID or QD, PO X 21 day cycle Number of cycles: until progression or unacceptable toxicity develops
16066962|NCT02405052|Other|No intervention|Validation of the Panic Screening Score
16066963|NCT02405039|Drug|EBI-005|EBI-005 is an intervention into one of two (2) study arms; 5 mg/mL topical administered 3 times per day
16066964|NCT02405039|Drug|Placebo|Placebo or Vehicle control comparator is an intervention into one of two (2) study arms; vehicle topical administered 3 times per day
16066965|NCT02405013|Drug|Sofosbuvir|Sofosbuvir 400mg QD (Sovaldi®) in treatment-naïve patients infected with HCV genotype 2 (12-week course)
16066966|NCT02405013|Drug|Ribavirin|Ribavirin weight-adjusted dosing (1000mg BID in patients < 75kg and 1200mg BID in patients ≥ 75kg) in treatment-naïve patients infected with HCV genotype 2 (12-week course)
16066967|NCT02405013|Drug|Sofosbuvir|Sofosbuvir/Ledipasvir 400mg/90mg (Harvoni®) in treatment-naïve patients infected with HCV genotype 1 or genotype 4 (12-week course)
16066968|NCT02405013|Drug|Ledipasvir|Sofosbuvir/Ledipasvir 400mg/90mg (Harvoni®) in treatment-naïve patients infected with HCV genotype 1 or genotype 4 (12-week course)
16066969|NCT02405000|Other|Intraoperative CT imaging|Intraoperative CT scan of the upper aerodigestive tract during laryngoscopy procedure
16066970|NCT02404987|Other|Nutritional Supplement|
16066971|NCT02404974|Behavioral|exercise|Participants will meet with a Certified Fitness Trainer and engage in shared goal setting and selection of a CDC-recommended exercise program for OA that best fits their needs and preferences, specifically addressing any identified barriers. The Trainer will use programs from a vetted list of programs that are appropriate for older adults with knee OA, and modify as needed. This list will be developed with the Certified Fitness Trainer and the PI. The Trainer will be available to answer questions and will contact each participant by phone every two weeks to find out how participants are doing; make adjustments to the program, if needed; and provide motivation and encouragement.
16066972|NCT02404961|Other|Vulvodynia|Comparison of reproductive, gynecological and environmental exposures, psychological trauma and psychiatric morbidity, and biological markers of immuno-inflammation and nerve fiber proliferation between cases and controls to determine potential etiology of vulvodynia.
16066973|NCT02404948|Other|Diagnostic algorithm|Validation of a diagnostic algorithm used to detect coronary artery disease and/or myocardial ischemia based on pulse wave analyses.
16066974|NCT02404935|Drug|Cetuximab|
16066975|NCT02404935|Drug|FOLFIRI and cetuximab|
16066976|NCT02404922|Drug|CTP-730|
16066977|NCT02404922|Drug|Placebo for CTP-730|
16066978|NCT02404909|Other|IVC diameters evaluation by intraoperative ultrasound|Out of consecutive patients who underwent hepatectomy for primary and secondary liver tumors, patients in whom IVC diameters were intraoperatively measured for clinical reasons were retrospectively selected and analyzed
16066979|NCT02404896|Drug|Metreleptin|Metreleptin open-label treatment
16066980|NCT02404883|Other|Online Decision-Aid Tool|
16066981|NCT02404870|Drug|Placebo|Placebo
16066982|NCT02404870|Drug|Canagliflozin|Canagliflozin is a new oral drug for the treatment of type 2 diabetes mellitus (T2DM), and is one of two recently FDA approved sodium glucose co-transporter 2 (SGLT2) inhibitors, which target renal glucose reabsorption and offer promising improvement in HbA1C.
16066983|NCT02404857|Device|EEG based Brain Computer Interface|Using EEG signals to classify brain activity being 'rest' or 'active' to control the attached pneumatic glove and close the sensory-motor loop between intentional/mental movement and physical (though passive) movement.
16066984|NCT02404844|Drug|BKM120|daily oral
16066985|NCT02404844|Drug|Tamoxifen|daily oral
16066986|NCT02404831|Other|Web-based PR|Participants will undertake web-based PR twice/week for 6 weeks in their own home. They will be given individual log-in details to access the website with access to exercises and education pages. Participants will be provided with a standardised exercise programme at the start of the study. The level of intensity of exercises will be progressed as appropriate on an individual basis for all participants in the group. Participant log-ins and diaries will be monitored remotely and participants will be telephone at weeks 2 and 4 by their physiotherapist to discuss their progress and, at this time, exercises may be progressed by changing the level of difficulty/intensity. This is done remotely by physiotherapy staff.
16066987|NCT02404831|Other|Hospital-based PR|Participants allocated to this group will undertake hospital-based PR twice per week for 6 weeks in. Participants attend PR classes and complete a circuit based exercise class. The level of intensity of exercises will be progressed as appropriate on an individual basis for all participants in the group. Following each class they will receive educational information about their condition.
16066988|NCT02404818|Procedure|Cardiac Magnetic Resonance Imaging|A cardiac MRI will be performed.
16066989|NCT02404818|Procedure|Echocardiogram|An echocardiogram will be performed for the following information: M-mode, two-dimensional, Doppler blood flow measurements, and longitudinal strain and strain rate imaging
16066990|NCT02404805|Drug|dolutegravir|dolutegravir tablets 50mg, once daily x 7 days.
16066991|NCT02404805|Drug|simeprevir|simeprevir tablets 150mg, once daily x 7 days.
16066992|NCT02404792|Other|High-intensity cardiovascular and resistance exercise|
16066993|NCT02404792|Other|Moderate-intensity cardiovascular and resistance exercise|
16066997|NCT02404766|Other|C7-T1 ventral cranial glide manual mobilization|
16066998|NCT02404753|Drug|Neoadjuvant Chemotherapy|XELOX: Oxaliplatin 130mg/m2,iv.,d1;Capecitabine 1000mg/m2,po.,Bid,d1-14; Repeat every 21 days for 3 courses.
16066999|NCT02404753|Procedure|Laparoscopic gastrectomy|Laparoscopic distal gastrectomy with D2 lymph node dissection
16067000|NCT02404753|Procedure|Open gastrectomy|Open distal gastrectomy with D2 lymph node dissection
16067001|NCT02404753|Drug|Adjuvant Chemotherapy|XELOX: Oxaliplatin 130mg/m2,iv.,d1;Capecitabine 1000mg/m2,po.,Bid,d1-14; Repeat every 21 days for 5 courses.
16067002|NCT02404740|Device|Pulse oximetry|Pulse oximetry
16067003|NCT02404727|Procedure|cup fixation|All patients will preoperatively, 3 months, 1 year, 2 year and 5 year have the hip DXA scanned, answer PROM, X-ray for RSA analysis and wear measurements, and wear accelerometry chip 14 days prior each outward clinic visit for movement analysis.
16067004|NCT02404727|Device|Avantage® Cup|
16067005|NCT02404714|Device|Iontophoresis sweat test|The intervention is iontophoretic sweat testing which includes the stimulation, collection and analysis of sweat. The standard of care sweat testing used at each institution will be compared to a new iontophoresis sweat test called the CF Quantum.
16067006|NCT02404701|Dietary Supplement|Aloe vera with cactus|Eligible participants who provide consent/authorization will report for an orientation visit (1 of 3 visits), during which participants will: provide a medical history and a 24-hour diet recall, have height and weight measured, learn how to collect 24-hour urine, receive instructions on following a standardized diet for 7 days, learn to use a food scale and provide diet records, and receive a 4-day supply of the supplement they were allocated to take along with instructions. After 3 days on the diet (no supplement), participants will return their first (of 2) diet record and 24-hour urine collection. After 4 days on the diet while taking the supplement, participants will return their second (and final) completed diet record and their second (and final) 24-hour urine collection.
16067007|NCT02404701|Dietary Supplement|Cranberry|Eligible participants who provide consent/authorization will report for an orientation visit (1 of 3 visits), during which participants will: provide a medical history and a 24-hour diet recall, have height and weight measured, learn how to collect 24-hour urine, receive instructions on following a standardized diet for 7 days, learn to use a food scale and provide diet records, and receive a 4-day supply of the supplement they were allocated to take along with instructions. After 3 days on the diet (no supplement), participants will return their first (of 2) diet record and 24-hour urine collection. After 4 days on the diet while taking the supplement, participants will return their second (and final) completed diet record and their second (and final) 24-hour urine collection.
16067008|NCT02404701|Dietary Supplement|Green tea extract|Eligible participants who provide consent/authorization will report for an orientation visit (1 of 3 visits), during which participants will: provide a medical history and a 24-hour diet recall, have height and weight measured, learn how to collect 24-hour urine, receive instructions on following a standardized diet for 7 days, learn to use a food scale and provide diet records, and receive a 4-day supply of the supplement they were allocated to take along with instructions. After 3 days on the diet (no supplement), participants will return their first (of 2) diet record and 24-hour urine collection. After 4 days on the diet while taking the supplement, participants will return their second (and final) completed diet record and their second (and final) 24-hour urine collection.
16067009|NCT02404701|Dietary Supplement|Bilberry|Eligible participants who provide consent/authorization will report for an orientation visit (1 of 3 visits), during which participants will: provide a medical history and a 24-hour diet recall, have height and weight measured, learn how to collect 24-hour urine, receive instructions on following a standardized diet for 7 days, learn to use a food scale and provide diet records, and receive a 4-day supply of the supplement they were allocated to take along with instructions. After 3 days on the diet (no supplement), participants will return their first (of 2) diet record and 24-hour urine collection. After 4 days on the diet while taking the supplement, participants will return their second (and final) completed diet record and their second (and final) 24-hour urine collection.
16067010|NCT02404701|Dietary Supplement|Cinnamon|Eligible participants who provide consent/authorization will report for an orientation visit (1 of 3 visits), during which participants will: provide a medical history and a 24-hour diet recall, have height and weight measured, learn how to collect 24-hour urine, receive instructions on following a standardized diet for 7 days, learn to use a food scale and provide diet records, and receive a 4-day supply of the supplement they were allocated to take along with instructions. After 3 days on the diet (no supplement), participants will return their first (of 2) diet record and 24-hour urine collection. After 4 days on the diet while taking the supplement, participants will return their second (and final) completed diet record and their second (and final) 24-hour urine collection.
16067011|NCT02404701|Dietary Supplement|Milk thistle|Eligible participants who provide consent/authorization will report for an orientation visit (1 of 3 visits), during which participants will: provide a medical history and a 24-hour diet recall, have height and weight measured, learn how to collect 24-hour urine, receive instructions on following a standardized diet for 7 days, learn to use a food scale and provide diet records, and receive a 4-day supply of the supplement they were allocated to take along with instructions. After 3 days on the diet (no supplement), participants will return their first (of 2) diet record and 24-hour urine collection. After 4 days on the diet while taking the supplement, participants will return their second (and final) completed diet record and their second (and final) 24-hour urine collection.
16067012|NCT02404701|Dietary Supplement|Turmeric|Eligible participants who provide consent/authorization will report for an orientation visit (1 of 3 visits), during which participants will: provide a medical history and a 24-hour diet recall, have height and weight measured, learn how to collect 24-hour urine, receive instructions on following a standardized diet for 7 days, learn to use a food scale and provide diet records, and receive a 4-day supply of the supplement they were allocated to take along with instructions. After 3 days on the diet (no supplement), participants will return their first (of 2) diet record and 24-hour urine collection. After 4 days on the diet while taking the supplement, participants will return their second (and final) completed diet record and their second (and final) 24-hour urine collection.
16067039|NCT02404493|Device|EpiCeram Skin Barrier Emulsion|EpiCeram Skin Barrier Emulsion
16067040|NCT02404493|Drug|1% Colloidal Oatmeal Balm|Experimental Product 1% Colloidal Oatmeal Balm
16067041|NCT02404480|Drug|PTC596|PTC 596 will be administered orally twice a day until unmanageable toxicity, disease progression, or withdrawal of consent is noted
16067013|NCT02404701|Dietary Supplement|Aloe vera|Eligible participants who provide consent/authorization will report for an orientation visit (1 of 3 visits), during which participants will: provide a medical history and a 24-hour diet recall, have height and weight measured, learn how to collect 24-hour urine, receive instructions on following a standardized diet for 7 days, learn to use a food scale and provide diet records, and receive a 4-day supply of the supplement they were allocated to take along with instructions. After 3 days on the diet (no supplement), participants will return their first (of 2) diet record and 24-hour urine collection. After 4 days on the diet while taking the supplement, participants will return their second (and final) completed diet record and their second (and final) 24-hour urine collection.
16067014|NCT02404688|Drug|Active delta-9-THC|"Low dose (0.015 mg/kg = 1.05 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately 1/4 of a marijuana cigarette, or joint. Administered over 20 minutes."
16067015|NCT02404688|Drug|Placebo|Control: small amount of alcohol (quarter teaspoon), with no THC. Administered over 20 minutes.
16067016|NCT02404688|Drug|Active Ethanol|Target BrAC of 0.04% reached over 20 minutes and then clamped to maintain this dose for an additional 60 minutes. This dose is equivalent to consuming approximately 2 drinks over 1 hour. Administered over a total of 80 minutes.
16067017|NCT02404688|Drug|Placebo|Control: no alcohol, administered for a total of 80 minutes.
16067018|NCT02404675|Drug|icotinib|
16067019|NCT02404662|Other|Supportive text messages intervention|"The supportive text messages are based on existing aphorisms in the recovery literature. Each day patients will receive one message targeting mood and another message targeting abstinence from alcohol in accordance with the primary aims of our study. An example text message aimed at improving mood is: Monitor changes in your mood; develop a list of personal warning signs. An example message targeting abstinence is: Keep Sobriety as a number one priority and you will reach your goals. None of the messages will be repeated. The messages will be sent in the morning and evening, with the theme (mood/alcohol) of the messages pseudo-randomised according to delivery time, so that no more than three successive days will have the same theme sent at the same time slot."
16067020|NCT02404662|Other|Control group|The control group will receive treatment as usual, as well as fortnightly thank you text messages and calls to ensure that they are still using their phone.
16067021|NCT02404649|Device|Two implant designs in a Sinus Bone Augmentation Procedure|Comparing TMDI (Zimmer Dental- Carlsbad, CA, USA) and Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA) biological behavior after a sinus bone augmentation procedure.
16067022|NCT02404649|Device|Two implant designs in a Sinus Floor Elevation Procedure|Comparing TMDI (Zimmer Dental- Carlsbad, CA, USA) and Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA) biological behavior after a sinus elevation only procedure.
16067023|NCT02404636|Other|Interview|Brief structured interview
16067024|NCT02404623|Dietary Supplement|Vitamin D|also known as Cholecalciferol, is one of the two most important compounds within the group of Vitamin D. It can be ingested from the diet and from supplements. In this study it is pharmacologically acquired and referred to as Vitamin D
16067025|NCT02404610|Procedure|Moderate Procedural Sedation with a sedative medication.|procedural sedation with a target sedation depth of moderate. Moderate sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids.
16067026|NCT02404610|Procedure|Deep Procedural Sedation with a sedative medication.|procedural sedation with a target sedation depth of deep. Deep sedation is not a drug specific intervention, it is achieved with the use of a sedative or a combination of sedations and opioids.
16067027|NCT02404610|Drug|propofol|
16067028|NCT02404597|Device|NICOM (non-invasive cardiac output monitor)|"The non-invasive cardiac output monitor (NICOM) will be used to tailor fluid management to optimize resuscitation if the patient has an episode of hypotension (defined as systolic blood pressure <100 or mean arterial pressure <65). NICOM consists of two electrodes placed on the patient's chest and back and uses bioreactance technology to transduce signals to compute hemodynamic parameters on an associated monitor.
~The electrodes will remain on the patient for twenty minutes. Once the electrodes are in place the patient's leg will be raised to 45 degrees and the monitor to which the electrodes are attached will generate a number that reflects stroke volume of the heart. The electrodes will be removed once this number is determined."
16067029|NCT02404584|Genetic|Blood drawn for genotyping|Blood will be drawn for genotyping (predefined list of genes) just before the start of sunitinib (baseline).
16067030|NCT02404584|Biological|Blood drawn for pharmacokinetic measures|"Blood will be drawn for pharmacokinetic measures between CmD15 and CmD28 of each sunitinib cycle.*
~*Each patient will undergo several cycles of treatment with sunitinib during the monitoring period as part of routine care (= 18 months; the number of cycles per patient can vary, which is normal). Each cycle and each day of the cycle will be annotated with the letters C and D, respectively, followed by a number in chronological order. Thus C1D1 refers to to the first day of the first cycle; CmDn will be the nth day of the mth cycle."
16067031|NCT02404571|Drug|GDP chemotherapy|gemcitabine (1000mg/m2 intravenously over 30 minutes on days 1 and 8), cisplatin (25mg/m2 intravenously over 60 minutes on days 1-3), and dexamethasone (20mg/d orally on days 1-4 and days 11-14), which was administered every 21 days.
16067032|NCT02404558|Drug|sarilumab SAR153191 (REGN88)|Pharmaceutical form:solution Route of administration: Subcutaneous injection
16067033|NCT02404558|Drug|tocilizumab|Pharmaceutical form:solution Route of administration: Subcutaneous injection
16067034|NCT02404545|Device|Ethicon Physiomesh|Ethicon Physiomesh will be paced at the time of radical cystectomy and ileal conduit.
16067035|NCT02404532|Device|MIND1 System|Following placement of the Patch by clinic staff, subjects will ingest one placebo-embedded IEM tablet approximately every other hour, for a total of 4 ingestions. Subjects may eat as they wish over the course of the day. Placebo-embedded IEM tablets are being tested to measure the accuracy of IEM detection by the MIND1 system. Clinic staff will record the time of each ingestion of an IEM. Clinic staff will check the compatible computing device (eg, smartphone) at 30-minute intervals for the presence of a timeline ingestion tile and will record the time it is detected by the MIND1 System compatible computing device (eg, smartphone).
16067036|NCT02404519|Dietary Supplement|Menaquinone-7|1 tablet containing 180 micrograms MK-7 taken orally every day during 1 year
16067037|NCT02404519|Dietary Supplement|Placebo|1 tablet without MK-7 taken orally every day during 1 year
16067038|NCT02404506|Drug|Eribulin mesilate|Eribulin mesiylate 1.1mg/m2 d1, 8 every 3 weeks until Progressive disease PD
16067042|NCT02404467|Device|TF TAVI|Follow-up Observation of patients having received a TF-TAVI
16067043|NCT02404454|Procedure|Hysteroscopic metroplasty|
16067044|NCT02404454|Device|Autocross-linked acid hyaluronic gel|Patients received adhesion barrier with 5 ml of autocross-linked acid hyaluronic gel
16067045|NCT02404454|Procedure|Office second look hysteroscopy|Second-look hysteroscopy after three months
16067046|NCT02404441|Biological|PDR001|anti-PD1 antibody
16067047|NCT02404428|Dietary Supplement|Standard broccoli soup|300g/week of standard broccoli soup consumed for a period of six months delivering standard level of glucoraphanin (sulforaphane precursor)
16067048|NCT02404428|Dietary Supplement|Beneforte extra broccoli soup|300g/week of beneforte extra broccoli soup consumed for a period of six months delivering enriched levels of glucoraphanin (sulforaphane precursor)
16067049|NCT02404402|Other|LED|Low Level Light Therapy
16067050|NCT02404402|Other|sham LED|Inactive (sham) LED treatment
16067051|NCT02404389|Drug|Investigational Treatment|Topical application for two treatment cycles with twice daily applications, separated by a 4 week treatment pause and followed by 8 week treatment free follow-up.
16067052|NCT02404389|Drug|Active comparator|Topical treatment with Aldara 3 times per week. The group will be open-label, but however blinded to the efficacy assessor, and followed by 8 week treatment free follow-up.
16067053|NCT02404376|Drug|Exenatide|Intravenous administration of Exenatide
16067054|NCT02404376|Other|Remote Ischemic Conditioning (RIC)|Remote ischemic conditioning with a cuff in the arm
16067055|NCT02404376|Drug|Placebo|Intrevenous administration of Placebo
16067056|NCT02404363|Drug|Clopidogrel|"Clopidogrel tablets 75 mg for six months:
~In case of treatment with aspirin < or = 75 mg/d or prophylactic LMWH --> clopidogrel 75 mg/d If aspirin = 0 + LMWH = 0 --> clopidogrel 150 mg/d x 7days then 75mg/d"
16067057|NCT02404363|Drug|Placebo|"Placebo tablets 75 mg for six months:
~In case of treatment with aspirin < or = 75 mg/d or prophylactic LMWH --> placebo 75 mg/d If aspirin = 0 + LMWH = 0 --> placebo 150 mg/d x 7days then 75mg/d"
16067058|NCT02404350|Biological|Secukinumab|Anti IL-17a monoclonal antibody
16067059|NCT02404337|Drug|Betaine|
16067060|NCT02404324|Other|Prescription of spectacles|All children are prescribed full optical correction of refractive errors with special attention to astigmatism up to 0.5 Dptr to achieve maximal clear image on the retina of both eyes.If necessary, direct occlusion or penalization are administered to the children.
16067061|NCT02404311|Biological|ALVAC-HIV|a lyophilized vaccine for injection at a viral titer ≥ 1 × 10E6 cell culture infectious dose (CCID)50 and < 1 × 10E8 CCID50 (nominal dose of 10E7 CCID50) and is reconstituted with 1mL of sterile sodium chloride solution (NaCl 0.4%) for intramuscular (IM) injection as a single dose.
16067062|NCT02404311|Biological|Bivalent Subtype C gp120/MF59®|2 recombinant monomeric proteins, each at a dose of 100 mcg, mixed with MF59® adjuvant (an oil-in-water emulsion) delivered as a 0.5 mL IM injection
16067063|NCT02404311|Biological|ALVAC-HIV (vCP2438) Placebo|a sterile, lyophilized product that consists of a mixture of virus stabilizer, and freeze drying medium and is reconstituted with 1mL of sterile sodium chloride solution (NaCl 0.4%) for injection as a single dose IM
16067064|NCT02404311|Biological|Bivalent gp120/MF59® Placebo|Sodium chloride for injection, 0,9% delivered as a 0.5 mL IM injection
16067065|NCT02404298|Drug|IVIg|
16067066|NCT02404285|Drug|Next Science Acne Gel|Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.
16067067|NCT02404285|Drug|Vehicle|Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel.
16067068|NCT02404272|Other|Educational oral feeding nurse program|"A multidisciplinary group composed of childcare assistants, nurse guardians, speech therapist, physiotherapist, psychologist, and pediatricians will develop and implement the educational oral feeding program. They will provide the 2-day theoretical session as well as the three 2-hour practical sessions including reviews of video recording preterm neonates during bottle or breast feedings.
~The program will focus on non-nutritive sucking for all neonates from 24 up to 34 weeks' of gestation, early oral feeding from 29 weeks' of gestation and oral stimulation for all preterm neonates admitted to the unit. Additionally, all preterm neonates presenting feeding difficulties symptoms will be evaluated weekly by a physiotherapist or speech therapist.
~Each program session is composed of 20 nurses or childcare assistants. Six sessions will be organized in total and all nurses and childcare assistants will be trained"
16067069|NCT02404259|Drug|TDF (Tenofovir)|
16067070|NCT02404259|Drug|Efavirenz|
16067071|NCT02404259|Drug|lopinavir/ritonavir, atazanavir/ritonavir|
16067072|NCT02404246|Behavioral|Peer support program|
16067073|NCT02404233|Drug|darunavir/cobicistat|Darunavir/ cobicistat 800/ 150 mg tablet once daily taken with food
16067074|NCT02404233|Drug|rilpivirine|Rilpivirine tablet 25 mg once daily taken with food
16067075|NCT02404220|Drug|Entospletinib|
16067076|NCT02404220|Drug|Vincristine|
16067077|NCT02404220|Drug|Dexamethasone|
16067078|NCT02404220|Drug|CNS Prophylaxis|
16067079|NCT02404207|Other|Soybean oil|Participants will be fed soybean oil as part of a controlled (typical American) diet.
16067080|NCT02404207|Other|High-oleic soybean oil|Participants will be fed high-oleic soybean oil as part of a controlled (typical American) diet.
16067081|NCT02404207|Other|High-oleic soybean oil + fully hydrogenated soybean oil|Participants will be fed a blend of high-oleic soybean oil and fully hydrogenated soybean oil as part of a controlled (typical American) diet.
16067082|NCT02404207|Other|Palm olein + palm stearin|Participants will be fed a blend of palm olein + palm stearin as part of a controlled (typical American) diet.
16067123|NCT02403882|Behavioral|Packaging|In the packaging intervention, the investigator present the targeted product in the original package. In the control, the investigator repackage the targeted product in clear, plastic bags.
16067222|NCT02403284|Drug|Sugar Pill|Subcutaneous injection daily
16067083|NCT02404194|Behavioral|Targeted Cognitive Training|Targeted Cognitive Training is performed on the computer through Posit Science. Games are modern and engaging modifications of classic neuropsychological tests, such as set-shifting games modeled on the Wisconsin Card Sort Test, and cognitive control games modeled on Stroop-like interference tasks. Games will target two sets of skills: Targeted cognitive skills include: processing speed, memory, attention, flexibility/cognitive-control, and problem-solving. After 20 hours of training on these skills, participants will complete 20 hours of training on core social cognitive skills, including facial affect recognition, gaze direction perception, and face identity recognition, and theory of mind.
16067084|NCT02404194|Behavioral|Computer Games|The comparison intervention consists of 40 hours of commercially available and cognitively non-specific computer games. These computer games - such as checkers, solitaire, crossword puzzles - are entertaining and engaging but do not target specific neurocognitive skills.
16067085|NCT02404168|Drug|lamotrigine (brand Lamictal)|an anti-epileptic drug (brand)
16067086|NCT02404168|Drug|lamotrigine (generic Teva)|an anti-epileptic drug (brand)
16067088|NCT02404142|Drug|Curare (Atracurium)|Curare (Atracurium) versus saline isotonic solution for tracheal intubation
16067089|NCT02404142|Drug|saline isotonic solution|
16067090|NCT02404129|Other|Turn 180 test|"The purpose of this study is to explore the TURN180 test ability to evaluate the risk of falling in the elderly population and compare it to the known gold standard clinical tests. The independent elderly subjects will be divided into three groups according to their falls history and undergo four balance tests: Timed Up and Go test (TUG), Tinetti Balance Test (Tinetti), Berg Balance Scale (BBS). The participants will be videotaped while performing the TUG test. Basic temporospatial aspects of turning during walking such as the number of steps taken during the turn and the time taken to accomplish the turn will be measured using both the slow-motion and stop-action capabilities of the VCR system and a time-code processor."
16067091|NCT02404116|Other|Metacognitive Therapy|Participants will receive treatment which focus's on helping reduce excessive thinking about health,
16067092|NCT02404116|Other|Wait List|Individuals are on a waiting list
16067093|NCT02404103|Drug|Flunisolide HFA|
16067094|NCT02404090|Radiation|CT-osteoarbsorptiometry|Conventional CT-scan analyzed by means of a specific tool (Analyze, Mayo Clinic).
16067095|NCT02404077|Drug|Clonidine|
16067096|NCT02404064|Drug|cefamezin 1g IV|perioperative antibiotics (Cefamizin 1g IV; )
16067097|NCT02404064|Drug|metronidazole 500 mg IV|perioperative antibiotics (metronidazole 500 mg IV )
16067098|NCT02404064|Drug|Placebo|No perioperative antibiotics
16067099|NCT02404051|Drug|Everolimus|10 mg daily tablets
16067100|NCT02404051|Drug|Exemestane|25 mg daily tablets
16067101|NCT02404051|Drug|Fulvestrant|500 mg i.m. on Days 1, 15 and 29 and every 28 days thereafter
16067102|NCT02404038|Drug|Nur-Isterate|Nur-Isterate is a progestogen-only injectable contraceptive (POIC) is a long-acting, reversible contraceptive. Nur-Isterate is administered as an intramuscular injection administered bi-monthly (every 8 weeks). Each ampoule of Nur-Isterate contains 1ml/200mg of norethisterone enantate (17alpha-ethinyl-17beta-heptanoyloxy-4-estrene-3-one).
16067103|NCT02404038|Device|Nuvaring|Nuvaring is the trade name for a combined hormonal contraceptive intravaginal ring, inserted once every 28 days, and removed after 21 days. The flexible plastic ring works in a similar way to the oral contraceptive pill to prevent pregnancy. It contains etonogestrel/ethinyl estradion and delivers 0.120mg/0.015mg per day.
16067104|NCT02404038|Drug|Triphasil|"Triphasil is a daily oral contraceptive: 21 active tablets followed by 7 inert tablets, starting initially on first day of menstrual cycle
~Composition:
~The six brown tablets of TRIPHASIL contain 30 µg ethinyl oestradiol and 50 µg levonorgestrel.
~The five white tablets contain 40 µg ethinyl oestradiol and 75 µg levonorgestrel.
~The ten yellow tablets contain 30 µg ethinyl oestradiol and 125 µg levonorgestrel.
~The seven red tablets are inert"
16067105|NCT02404025|Drug|Eltrombopag|Eltrombopag was provided as white round film-coated tablets containing 12.5 mg or 25 mg of eltrombopag free acid (SB-497115-GR, eltrombopag).
16067106|NCT02404025|Drug|Rabbit ATG|Rabbit ATG, as an intravenous drip infusion, diluted by 500 mL of saline or 5% glucose injection was administered at a dose of 2.5 to 3.75 mg per kg per day as a slow intravenous infusion over 6 hours.
16067107|NCT02404025|Drug|CsA|CsA as capsules, oral solution, or fine granule, was administered at a dose of 3 mg per kg twice a day.
16067108|NCT02404012|Dietary Supplement|Oral iron supplementation|Participants will be provided supplementation for 8 weeks
16067109|NCT02403999|Other|Test shampoo|Participants used Oilatum Soothe & Protect Shampoo at home in place of their usual wash product at least twice weekly for a two week period.
16067110|NCT02403999|Other|Test bath foam|Participants used Oilatum Soothe & Protect Bath Foam at home in place of their usual wash product at least twice weekly for a two week period.
16067111|NCT02403999|Other|Test head to toe wash|Participants used Oilatum Soothe & Protect Head to Toe Wash at home in place of their usual wash product at least twice weekly for a two week period.
16067112|NCT02403986|Device|Restylane Vital Skinboosters Lidocaine|
16067113|NCT02403973|Other|IN2005E|IN2005E is a validated questionnaire that measures patient satisfaction
16067114|NCT02403960|Dietary Supplement|probiotic|the patients used probiotic tablets in addition to scaling and root planning
16067115|NCT02403960|Dietary Supplement|placebo|the patients used placebo tablets in addition to scaling and root planning
16067116|NCT02403947|Drug|Mesenchymal stem cells|After the sampling of bone-marrow and culture of MSCs by the French Blood Establishment (Midi-Pyrénées), patients will receive an IV injection of MSCs.
16067117|NCT02403947|Drug|Suspension media|injection suspension media
16067118|NCT02403934|Device|Jaw Elevation Device (JED)|apply JED when End tidal O2 low
16067119|NCT02403908|Device|nMARQ Circular and Crescent catheters|Radiofrequency denervation of right and left pulmonary arteries ostia and of main pulmonary artery <2 mm proximal from both ostia of right and left pulmonary arteries.
16067120|NCT02403895|Drug|Open-label AZD2014|Dual TORC1/TORC2 inhibitor
16067121|NCT02403895|Drug|paclitaxel|Taxane
16067122|NCT02403882|Behavioral|Order|In the order intervention, the investigators place the targeted product at the front of the line for the treatment. For the control, the investigators place the targeted product at the end of the line.
16067124|NCT02403882|Behavioral|Pricing|In the pricing intervention, the investigators price all or targeted products in the treatment. In the control, the investigators do not price the products.
16067125|NCT02403882|Behavioral|Relative Proportions|The investigators adjust the amount of the targeted good available relative to the other products. In the treatment, the targeted good is a larger proportion of the total goods offered in the section, while in the control the shares of the targeted and other goods are equal.
16067126|NCT02403882|Behavioral|Default Option|In an early site, the investigators offer a targeted product without an alternative. The subjects can accept or reject the offer. The subjects are told that an alternative product is available later. At the site where the alternative product is available, investigators offer subjects the opportunity to exchanged the targeted product for the alternative product.
16067127|NCT02403856|Drug|Sodium Chloride 0.9%|Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of sterile physiological Saline (Sodium Chloride 0.9%) in the subacromial bursae.
16067128|NCT02403856|Drug|Methylprednisolone acetate|Needling and lavage of calcific tendinitis of the rotator cuff followed by the injection of methylprednisolone acetate in the subacromial bursae
16067129|NCT02403856|Procedure|Ultrasound-guided Needling and Lavage|
16067130|NCT02403843|Device|RNS System|The RNS System provides closed loop responsive brain stimulation. In response to detection of previously identified electrocorticographic activity, the neurostimulator delivers stimulation to the seizure foci by way of the leads to interrupt the activity before the patient experiences clinical seizures. The typical patient is treated with a cumulative total of 5 minutes of stimulation a day.
16067131|NCT02403830|Drug|Methylnaltrexone|Methylnaltrexone will be administered diluted with 5 ml of normal saline as a single iv bolus
16067132|NCT02403830|Other|Placebo|Placebo will be administered as a 0.9% sodium chloride iv injection
16067133|NCT02403830|Drug|Morphine|After methylnaltrexone, patients will receive 5-mg intravenous morphine
16067134|NCT02403830|Drug|Ticagrelor|After morphine administration, patients will receive a 180-mg ticagrelor loading dose
16067135|NCT02403817|Behavioral|Cognitive Training|A collection of video games that rely on various aspects of visual behavior (i.e. sustained attention, vigilance, rapid discrimination, etc) for successful play.
16067136|NCT02403817|Behavioral|Eye Motor Training|Game play will be controlled by the player's eye movements (via an eye tracking device)
16067137|NCT02403817|Behavioral|Hand Motor Training|Game play will be controlled by the player's hand movements (via a joystick).
16067138|NCT02403804|Dietary Supplement|Phosphatidylcholine|Phosphatidylcholine 3600 mg qam and 2700 mg qpm
16067139|NCT02403804|Dietary Supplement|Betaine (588 mg qam and 412 mg qpm)|Betaine anhydrous 588 mg qam and 412 mg qpm
16067140|NCT02403804|Dietary Supplement|Betaine (1000 mg BID)|Betaine anhydrous 1000 mg BID
16067141|NCT02403791|Device|Linear Ultrasonic Sounder|Lung ultrasound evaluation is performed after clinical assessment and before chest radiography
16067142|NCT02403791|Device|Bedside X-ray Machine|Chest Radiography is performed after clinical evaluation without using ultrasound assessment.
16067143|NCT02403778|Drug|VESANOID|All-trans retinoic acid (ATRA) is a vitamin A derivative that binds the retinoic acid receptor on MDSCs and differentiates immature monocytes into more mature dendritic cells (12). VESANOID is a standard treatment for patients with acute promyelocytic leukemia (APL).
16067144|NCT02403778|Drug|Ipilimumab|Ipilimumab is current standard of care treatment for melanoma.
16067145|NCT02403752|Behavioral|Paired PLIE Program|Integrative exercise as described above
16067146|NCT02403739|Other|No Intervention|No Intervention
16067147|NCT02403726|Procedure|Operation|Analyzation of demographic, medical, gender and socio-economic aspects of osteoporosis associated vertebral fractures treated with operation.
16067148|NCT02403726|Procedure|Non-operative treatment|Analyzation of demographic, medical, gender and socio-economic aspects of osteoporosis associated vertebral fractures treated with non-operative treatment.
16067149|NCT02403713|Drug|Fluticasone/formoterol BAI|Fluticasone/formoterol 125/5 µg breath actuated inhaler (BAI) (250/10 µg total dose)
16067150|NCT02403713|Drug|Formoterol|Formoterol
16067151|NCT02403713|Drug|Fluticasone/formoterol PMDI without spacer|Fluticasone/Formoteral 125/5µg pMDI without spacer
16067152|NCT02403713|Drug|Fluticasone/formoterol PMDI with spacer|Fluticasone/Formoteral 125/5µg pMDI with spacer
16067153|NCT02403713|Drug|Fluticasone/formoterol PMDI without spacer low dose|Fluticasone/Formoteral 125/5µg pMDI without spacer, low dose
16067154|NCT02403700|Device|Cone beam computed tomography (CBCT)|Dimensional changes are documented over a healing period of 8-weeks following single tooth extraction. To document these changes over time, two methods will be applied. Firstly, two cone beam computed tomographies (CBCT) will be obtained, one directly after tooth extraction, the other one at 8 weeks of socket healing prior to implant placement. The two CBCT's will be analyzed with a novel software program (InVivo Dental). Secondly, consecutive impressions will be made at day 0 (day of extraction), day 14, 28, 42, and 56 to digitally produce virtual 3D study models. These models can be analyzed with another software program (Geomagic Studi 10) to document the variations of the soft tissue in the extraction site.
16067155|NCT02403687|Drug|baclofen 2%|compound topical cream
16067156|NCT02403687|Drug|Bupivacaine hydrochloride 1%|compound topical cream
16067157|NCT02403687|Drug|Cyclobenzaprine hydrochloride 2%|compound topical cream
16067158|NCT02403687|Drug|Diclofenac Sodium 3%|compound topical cream
16067159|NCT02403687|Drug|Flurbiprofen 10%|compound topical cream
16067160|NCT02403687|Drug|Gabapentin 6%|compound topical cream
16067161|NCT02403687|Drug|Ketamine 10%|compound topical cream
16067162|NCT02403687|Drug|Lidocaine 2%|compound topical cream
16067163|NCT02403687|Drug|Prilocaine 2.5%|compound topical cream
16067164|NCT02403687|Drug|Meloxicam 0.09%|compound topical cream
16067165|NCT02403687|Drug|Sumatriptan 5%|compound topical cream
16067166|NCT02403687|Drug|Tizanidine 0.1%|compound topical cream
16067167|NCT02403687|Drug|Topiramate 2.5%|compound topical cream
16067168|NCT02403687|Drug|Capsaicin, USP 0.0375%|compound topical cream
16067169|NCT02403687|Drug|Menthol, NF 5.00 %|compound topical cream
16067170|NCT02403674|Drug|Doravirine, Tenofovir, Lamivudine|One doravirine, tenofovir, lamivudine tablet taken q.d. by mouth.
16067171|NCT02403674|Drug|ATRIPLA™|One ATRIPLA™ tablet taken q.d. by mouth
16067172|NCT02403674|Drug|Placebo|Placebo tablets matched to ATRIPLA® or Doravirine, Tenofovir, Lamivudine.
16067173|NCT02403661|Procedure|Post surgical electrical stimulation|Post surgical electrical stimulation immediately after surgical nerve repair
16067174|NCT02403648|Drug|BIOD-961|BIOD-961 is a lyophilized glucagon formulation.
16067175|NCT02403648|Drug|Lilly Glucagon|
16067176|NCT02403648|Drug|Novo Glucagon|
16067177|NCT02403635|Drug|Midazolam|
16067178|NCT02403635|Drug|ASP2151|
16067179|NCT02403622|Drug|Fecal Microbiota Preparation|Frozen processed human fecal material for treating recurrent Clostridium difficile infections.
16067180|NCT02403609|Other|BPT, Computerized Assessment|
16067181|NCT02403596|Drug|Exacyl®|
16067182|NCT02403596|Other|Placebo of Exacyl®|
16067183|NCT02403583|Behavioral|Intervention- Home Visits|If a woman has been randomized to the intervention arm, a lay health worker will obtain detailed locator information (including cell phone contacts) and consult with the woman about optimal times for a home visit. The woman will be given a letter for her male partner to inform him about the study and potential upcoming visits, given that our preliminary research revealed that notifying the male partner beforehand is important. As described above, the intervention arm will consist of three home visits conducted by one female and one male lay health worker.
16067184|NCT02403570|Other|Brain MRI|
16067185|NCT02403557|Behavioral|Waitlist|Weekly check up.
16067186|NCT02403557|Behavioral|Tailored Internet-delivered CBT|Tailored Internet-delivered CBT during 8 weeks.
16067187|NCT02403544|Radiation|IGRT|IGRT: 45 to 54Gy, 1.8-3Gy per fraction.
16067188|NCT02403544|Drug|Capecitabine|Capecitabine: by oral, D1-14, every 21 days, 600mg/m2 bid per day in level 1, and then escalated every another dose level.
16067189|NCT02403544|Drug|Oxaliplatin|Oxaliplatin: intravenously, D1 and D8, every 21 days, 30mg/m2 per day in level 1, and then escalated every another dose level.
16067190|NCT02403531|Drug|Docetaxel|Include brand names, serial numbers and code names to improve search results on the ClinicalTrials.gov web site.
16067191|NCT02403531|Drug|Cisplatin|Include brand names, serial numbers and code names to improve search results on the ClinicalTrials.gov web site.
16067192|NCT02403531|Radiation|Radiotherapy|definitive radiotherapy
16067193|NCT02403518|Device|Freedom Spinal Cord Stimulator System|
16067194|NCT02403505|Drug|ABIRATERONE - Group 1|ZYTIGA - ABIRATERONE ACETATE TABLET plus DELTASONE - PREDNISONE TABLET plus ELIGARD - Leuprolide Acetate Kit
16067195|NCT02403505|Drug|ABIRATERONE - Group 2|ZYTIGA - ABIRATERONE ACETATE TABLET plus DELTASONE - PREDNISONE TABLET plus TRELSTAR - Triptorelin Pamoate Kit
16067196|NCT02403492|Device|cPAP|All participants diagnosed with obstructive sleep apnea will be required to use cPAP for 6 months prior to the RCT component of this trial
16067197|NCT02403492|Device|cPAP, Continuation|Participants will be randomized to continue cPAP for a 2 week period
16067198|NCT02403492|Device|cPAP, Discontinuation|Participants will be randomized to discontinue cPAP for a 2 week period
16067199|NCT02403479|Drug|Silver Colloid|Topical silver colloid will be administered for 6 weeks. This will either occur before topical saline nasal spray. Participants are randomized as to the order of sprays. The commercially available silver colloid product, Sovereign Silver Mineral Supplement, will be used.
16067200|NCT02403479|Other|Saline|Topical saline will be administered for 6 weeks. This will occur before the topical silver colloidal nasal spray. Participants are randomized as to the order of sprays.
16067201|NCT02403466|Behavioral|Resident Handoff Bundle|1) team training, 2) verbal mnemonics, and 3) standardization of written/computerized handoff tools
16067202|NCT02403453|Device|Rhine Cervical Disc|RHINE Cervical Disc
16067203|NCT02403440|Drug|Hetrombopag Olamine|Hetrombopag Olamine 2.5mg, 5mg and 7.5mg
16067204|NCT02403427|Device|VoiceDiab expert system|"Decision support system VoiceDiab this is computer-based system constructed for mobile phone devices working on the server.
~Patients in experimental arm get the mobile phone application for 4 days. Glucose control will be done by two methods SMPG and CGM. Before every study's meal insulin dose with type of bolus will be indicate by VoiceDiab."
16067205|NCT02403414|Device|Fiberoptic|In the event of failed intubation under direct laryngoscopy, fiberoptic intubation will be performed.
16067206|NCT02403401|Drug|Levonorgestrel (BAY98-7196)|Levonorgestrel 40 µg/d intravaginal ring (treatment for 365 days, 28 days wearing period for each ring)
16067207|NCT02403388|Other|PRisM|A risk management program for each professional of care in multiprofessional primary care offices in France.
16067208|NCT02403375|Device|Accu-Chek Insight Pump System|Continuous subcutaneous insulin infusion pump
16067209|NCT02403362|Drug|EPO-018B|
16067210|NCT02403349|Drug|Fimasartan|
16067211|NCT02403349|Drug|Valsartan|
16067212|NCT02403349|Drug|Atenolol|
16067213|NCT02403336|Other|Training health professionals|Intervention on the professionals (3 training sessions for updating the knowledge and learning skills) and
16067214|NCT02403336|Behavioral|Behavioral group intervention|Intervention on patients (educational workshop).
16067215|NCT02403336|Other|Usual clinical practice|Professionals: meeting methodological of 30 minutes duration. Patients: Usual clinical practice. Health education individually on nursing consultation.
16067216|NCT02403323|Drug|Etrolizumab|105 mg etrolizumab subcutaneous administration once every 4 weeks
16067217|NCT02403310|Drug|Selinexor|"Induction: Oral selinexor on days 1, 3, 8, 10, 15 and 17.
~Dose Level 2: 80 mg twice weekly.
~Dose Level 1 (starting dose): 60 mg twice weekly.
~Dose Level -1: 40 mg twice weekly.
~Consolidation: Selinexor same dose as induction (days 1,3,8,10) unless dose limiting toxicity (DLT) dictates a dose reduction.
~Maintenance: Selinexor at the same dose as induction on days 1 and 8 a 21 day cycle. They will continue for a maximum of 12 months."
16067218|NCT02403310|Drug|Daunorubicin|"Induction: Daunorubicin 60 mg/m^2/day (days 1-3).
~Consolidation: Daunorubicin 45 mg/m^2/day (days 1-2)."
16067219|NCT02403310|Drug|Cytarabine|"Induction: Cytarabine 100 mg/m^2/day (days 1-7).
~Consolidation: Cytarabine 100 mg/m^2/day (continuous infusion on days 1-5)."
16067220|NCT02403297|Device|Quik Check PD|The device is not an intervention. It is a device to determine if MMP-8 is present in a subjects saliva.
16067221|NCT02403284|Drug|Liraglutide|Subcutaneous injection by patient
16067223|NCT02403271|Drug|Ibrutinib|BTK Inhibitor
16067224|NCT02403271|Drug|Durvalumab|Anti PDL-1
16067225|NCT02403258|Other|Plum-blossom needle group|Plum-blossom needle is a method of shallow insertion with multiple needles. It is made of five or seven stainless steel needles arranged in a pattern like the shape of plum blossom, thus named as 'plum-blossom needle'. Plum-blossom needle treat diseases by tapping specific skin areas or acupoints according to different illness based on the theory of meridian.
16067226|NCT02403258|Behavioral|HRT group|HRT consisted of (1) self-monitoring, (2) competing responses, (3) relaxation training, (4) contingency management.
16067227|NCT02403245|Other|Psychosocial stimulation|"Intervention consists in a session of social stimulation during about 40 minutes through where the speaker introduced himself to the residents and introduces the residents to each others. The date of the day was done to residents. Social stimulation consists here to an exercise about the four seasons. Residents are asked to mention the 4 seasons and to give all the characteristics they can about each season. Two exercises were proposed: 4 pictures of landscapes and residents were asked to tell which season is represent on the pictures and pictures of some fruits and residents tried to tell in which season we find the fruits. Finally, the psychologist speaks about the four season of the compositor Vivaldi and propose to the residents to listen some extracts of each pieces of music."
16067228|NCT02403232|Procedure|ASCs injection|"In the infiltration step, adrenalin in a saline solution is infiltrated using a 19-cm specially designed disposable blunt cannula.
~The aspiration step is performed by a luer-lock syringe connected to a disposable 19-cm blunt cannula.
~The harvested lipoaspirate can be progressively put into the device using multiple 10-cc syringes.
~Subsequently, in lithotomy position, a seton will be removed and a fistula tract will be thoroughly curetted and irrigated. After a mucosal flap preparing round the internal opening, cells will be injected in the perianal adipose tissue."
16067229|NCT02403232|Device|ASCs injection|In general anesthesia subcutaneous abdominal adipose tissue will be collected by LIPOGEMS system to prepare ASCS.
16067230|NCT02403232|Device|Closure of fistula tract.|A SALVECOLL-E paste will be injected into the fistula tract.
16067231|NCT02403219|Drug|Botulinum toxin type A injection|Injection of botulinum toxin type A
16067232|NCT02403219|Other|Saline solution injection|Injection of saline solution
16067233|NCT02403206|Device|Femtosecond laser|Laser console and a patient interface used to cut tissue during cataract removal of the crystalline lens
16067234|NCT02403206|Procedure|Continuous Curvilinear Capsulorhexis (CCC)|Standard-of care manual procedure (using either needles or forceps) for creating capsulorhexis, ie., opening in capsular bag during anterior segment ophthalmic surgery
16067235|NCT02403193|Drug|PBF-509_80 mg|PBF-509: 80 mg, PO, twice daily (BID)
16067236|NCT02403193|Drug|PBF-509_160 mg|PBF-509: 160 mg, PO, twice daily (BID)
16067237|NCT02403193|Drug|PBF-509_320 mg|PBF-509: 320 mg, PO, twice daily (BID)
16067238|NCT02403193|Drug|PBF-509_640 mg|PBF-509: 640 mg, PO, twice daily (BID)
16067239|NCT02403193|Drug|Combo PBF-509 (160 mg) + PDR001|Drug 1: PDR001 administered intravenously. Drug 2: PBF-509 administered orally
16067240|NCT02403193|Drug|Combo PBF-509 (320 mg) + PDR001|Drug 1: PDR001 administered intravenously. Drug 2: PBF-509 administered orally
16067241|NCT02403193|Drug|Combo PBF-509 (640 mg) + PDR001|Drug 1: PDR001 administered intravenously. Drug 2: PBF-509 administered orally
16067242|NCT02403193|Drug|RP2D (PBF-509+PDR001)_immuno naïve|Drug 1: PDR001 administered intravenously. Drug 2: PBF509 administered orally
16067243|NCT02403193|Drug|Experimental: RP2D (PBF-509+PDR001)_immuno treated|Drug 1: PDR001 administered intravenously. Drug 2: PBF509 administered orally
16067244|NCT02403180|Device|DACP MF|Nelfilcon A multifocal contact lenses
16067245|NCT02403180|Device|PROCLEAR 1D MF|Omafilcon A multifocal contact lenses
16067246|NCT02403154|Procedure|Internal Fixator|Internal fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are inserted under the skin, internally.
16067247|NCT02403154|Procedure|External fixator|External fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are outside of the body.
16067248|NCT02403141|Other|Questionnaire|
16067249|NCT02403128|Drug|aflibercept|Intravitreal injection of 2.0 mg aflibercept at baseline, and repeated no sooner than two months from the previous injection for persistent macular edema as defined in the protocol.
16067250|NCT02403115|Other|Serum collection|Clinical tests (renal function, complete blood count, CRP, ANA, dsDNA, urinalysis) will be performed at fixed time intervals (6, 12, 24 and 36 months) and the surplus of blood sample will form the serum bank used for the study
16067251|NCT02403089|Other|Tubes fund recovery blood count|Tubes fund recovery of blood counts among newborns
16067252|NCT02403089|Other|the rest of the blood test and stool sample|blood samples on the recovery kinetics after transplant. The rest of the blood test and stool sample done as part of a routine examination.
16067253|NCT02403063|Drug|Sugammadex|Administration of sugammadex 2mg/kg for enhanced recovery after neuromuscular blockade with rocuronium
16067254|NCT02403063|Drug|Neostigmine|Administration of neostigmine 50µg/kg for enhanced recovery after neuromuscular blockade with rocuronium
16067255|NCT02403063|Drug|Neostigmine-sugammadex|Administration of neostigmine 50µg/kg followed 3 minutes later by administration of sugammadex 2mg/kg for enhanced recovery after neuromuscular blockade with rocuronium
16067256|NCT02403050|Device|Fiducial markers|2 fiducial markers (Visicoils) to be placed in the tumor area
16067257|NCT02403037|Device|True auricular acupressure|A 5-day auricular acupressure at the specific ear acupoints using vaccaria seeds.
16067258|NCT02403037|Device|Sham auricular acupressure|A 5-day sham auricular acupressure at the same acupoints as in the true auricular acupressure arm using Junci Medulla but no pressure will be applied.
16067259|NCT02403037|Drug|Standard anti-emetic treatment (5-HT3 receptor antagonists and/or Dexamethasone)|5-HT3 receptor antagonists and/or Dexamethasone will be administered to manage chemotherapy-induced nausea and vomiting.
16067260|NCT02403024|Behavioral|InterWalk|Patient allocated to the InterWalk-group will be introduced to the InterWalk app, including instructions on how to down load and use the application. and prescribed to perform Interval Walking for 150 min per week
16067346|NCT02402439|Procedure|Islet transplantation into the gastrointestinal submucosa|Transplantation of islets into the gastrointestinal submucosa
16067261|NCT02403024|Behavioral|Waiting list control|Patients allocated to the waiting-list control group will be prescribed standard guidelines for the patient group, but will be asked not to download and use the InterWalk app (which is freely available) for the first 12 weeks of the study period. After the first 12 weeks (the control period), patients in this group will receive the same instructions for download and use of the InterWalk app in the following 12 weeks
16067262|NCT02403011|Other|soft tissue mobilization|soft tissue mobilization technique has three phases. First phase 'the passive mobilization phase' is applied by gentle but tight gripping of the SKM muscle two or three fingers below the muscle origo and the muscle is mobilized rhythmically in the antero-posterior direction. Secondly, after gently continue to hold the muscle the baby was encouraged to do active repetitive cervical rotation to the affected side by means of catching the babies attention with colored and sonorous toys. Third phase was mobilization with stretching. Caregiver holds the baby on his/ her affected side while the therapist gently grips and withholds the muscle. Therapist mobilizes the muscle in the antero-posterior direction and stretch the muscle
16067263|NCT02403011|Other|home program controlled once six weeks|Home program which consisted of positioning the neck and head, handling strategies, stretching exercises, strengthening exercises according to babies neurodevelopmental level and environmental adaptations
16067264|NCT02402998|Drug|Eltrombopag|Eltrombopag 50 mg/daily.
16067265|NCT02402985|Other|High animal protein diet group|25-30% protein, 40 % carbohydrates, 30-35 % fat over 6 weeks
16067266|NCT02402985|Other|High plant protein diet group|25-30% protein, 40 % carbohydrates, 30-35 % fat over 6 weeks
16067267|NCT02402972|Drug|FUDR +oxaliplatin|IPC: one dose of fluorodeoxyuridine (FUDR) 1000 mg and oxaliplatin 100 mg were administered as a bolus into the regional vein
16067268|NCT02402972|Drug|oxaliplatin+Leucovorin+5-FU|Adjuvant chemotherapy (AC): All patients received mFOLFOX6 adjuvant chemotherapy: oxaliplatin+Leucovorin+5-FU
16067269|NCT02402959|Other|individualized treatment|Individualized treatment includes anything no matter what kind of interventions, like medicine, herbs, acupuncture, massage, behaviour therapy, diet and exercise therapy. The TCM experts should choose the intervention in accordance to the patients' preference, best existed evidence and their empirical knowledge.
16067270|NCT02402946|Behavioral|Biofeedback|
16067271|NCT02402946|Drug|Placebo|
16067272|NCT02402933|Drug|Nasal Glucagon|3 mg nasal glucagon powder
16067273|NCT02402920|Drug|Carboplatin|Given IV
16067274|NCT02402920|Drug|Cisplatin|Given IV
16067275|NCT02402920|Drug|Etoposide|Given IV
16067276|NCT02402920|Other|Laboratory Biomarker Analysis|Correlative studies
16067277|NCT02402920|Biological|Pembrolizumab|Given IV
16067278|NCT02402920|Procedure|Radiation Therapy|Undergo radiation therapy
16067279|NCT02402907|Device|2% chlorhexidine gluconate (CHG) cloth|administration of a 2% CHG cloth at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
16067280|NCT02402907|Device|Placebo cloth|administration of a cloth with the placebo (commercial cleansing cloth) at home on the night before and approximately 3 hours prior to cesarean delivery on the morning of the surgery.
16067281|NCT02402894|Other|no intervention|
16067282|NCT02402881|Behavioral|Patient-centered education bundle|A patient-centered education bundle that will be delivered as an in-person, 1-on-1 discussion session with a nurse educator. Supporting education materials include a 2-page patient education sheet and a patient education video.
16067283|NCT02402868|Drug|Ketamine and saline|Ketamine intravenous and intranasal
16067284|NCT02402855|Other|Delivery of a prepaid payment card|Delivery of a prepaid payment card credited according to consultations attended
16067285|NCT02402855|Other|Interview with a sociologist|For a sub-group of 40 womens
16067286|NCT02402855|Other|No intervention|
16067287|NCT02402842|Drug|Docetaxel, Cisplatin and 5-Fluorouracil|Patients will receive 6 cycles of DCF regimen (docetaxel 75 mg/m2 day, cisplatin 75 mg/m2 and 5 Fluorouracil at 750 mg/m2/day for 5 days) every 3 weeks or 8 cycles of modified-DCF regimen (docetaxel 40 mg/m2 day, cisplatin 40 mg/m2 day and 5-Fluorouracil at 1200 mg/m2/day for 2 days) every 2 weeks, according to their clinical status.
16067288|NCT02402829|Procedure|Peripheral Vein Blood draw|Drawing blood through a peripheral vein in the arm.
16067289|NCT02402816|Device|MultiPoint Pacing ON|MultiPoint Pacing ON
16067290|NCT02402816|Device|Implantable cardioverter-defibrillator (ICD)|Implantable cardioverter-defibrillator (ICD)
16067291|NCT02402803|Other|Dried blood spot testing and phlebotomy|At baseline and 4-6 week follow-up, a phlebotomy serum sample (5 ml) will be collected in one golden-top tube for clinical laboratory measurement of cholesterol (total cholesterol, LDL-C, triglycerides, HDL-C) . During the same phlebotomy, a fingerprick dried blood spot (DBS) sample and two lavender EDTA plasma tubes (5 ml each) will be collected for analysis of CVD protein markers
16067292|NCT02402764|Drug|Selinexor|Participants will receive selinexor twice weekly on Monday/Wednesday, Tuesday/Thursday or Wednesday/Friday of Weeks 1, 2 and 3 of each 4-week cycle. Selinexor will not be taken during Week 4. One cycle is defined as 28 days or 6 doses. The starting dose for this trial is 60 mg (flat dose as long as their dose-based body surface area (BSA) analysis does not exceed 70 mg/m^2).
16067293|NCT02402751|Procedure|acquisition of normative database with ultra high field MRI|characterize non-invasively with an unprecedented resolution and sensitivity (high field MRI), anatomy as well as certain physiological, hemodynamic and metabolic function of brain, spinal cord, musculoskeletal system, and heart
16067294|NCT02402751|Device|MRI|
16067295|NCT02402738|Behavioral|Interpersonal and Social Rhythm Therapy|
16067296|NCT02402738|Behavioral|Enhanced Treatment as Usual|
16067297|NCT02402725|Drug|Dexamethasone|(1 cycle = 28 days) D1: Dexamethasone 100mg IV; Dex 24mg PO every 6 hrs (begin immediately after IV dex) D2: Dex 24mg PO every 6 hrs D3: Dex 24mg PO every 6 hrs
16067298|NCT02402712|Drug|Docetaxel|Intravenous administration according to local label/clinical practice, after Herceptin and Perjeta.
16067299|NCT02402712|Drug|pertuzumab [Perjeta]|Intravenous infusion every 3 weeks. First dose: 840 mg. Subsequent doses: 420 mg
16067300|NCT02402712|Drug|trastuzumab [Herceptin]|Subcutaneous administration of 600 mg/5 mL every 3 weeks
16067347|NCT02402413|Procedure|Ultrasound|The patients will be subjected to ultrasound bi-dimensional or three-dimensional. Will Be calculated the ratio stroma/volume with both methods
16067301|NCT02402686|Drug|Tocilizumab|Dosing and treatment duration of tocilizumab collected as part of this non-interventional study are at the discretion of the physician in accordance with local clinical practice and local labeling. Observation period is 24 weeks from first SC tocilizumab administration.
16067302|NCT02402673|Other|Temporary activity modification and graded exercises|
16067303|NCT02402660|Drug|ALK-001|Daily, oral administration for 24 months
16067304|NCT02402660|Drug|Placebo|Daily, oral administration for 24 months
16067305|NCT02402647|Behavioral|CREST|"Compensatory Cognitive Training is a manualized, low-tech, cognitive training intervention designed to target cognitive impairments common in people with psychiatric illness. The CCT modules specifically selected for CREST map onto known areas of HD neurocognitive deficits or weakness and include training in prospective memory, prioritizing, problem solving, planning, and cognitive flexibility.
~Symptoms of acquiring and saving are themselves avoidance behaviors that are performed to avoid internal distress related to negative thoughts and emotions. Avoidance serves to reduce distress related to the beliefs regarding the necessity and utility of possessions. In the CREST condition, the second part and the majority of treatment is dedicated to exposure therapy (ET) for discarding and not acquiring while in the control condition, the entire treatment will consist of ET."
16067306|NCT02402647|Behavioral|ET|The investigators propose to use a robust control condition, ET, with the same frequency and amount of therapist contact as CREST. Twenty-six weekly, individual ET sessions (6 months) will be delivered. The control group will receive ET for all 26 sessions and no cognitive training. As in CREST, the ET sessions will be manualized and copies utilized during session by both the patient and therapist.
16067307|NCT02402634|Other|Mechanical ventilatory lung care|
16067308|NCT02402621|Drug|fentanyl|fentanyl with antiemetic drug
16067309|NCT02402608|Dietary Supplement|dietary supplement|oral essential amino acid (EAA), whey protein and vitamin D mixture
16067310|NCT02402608|Dietary Supplement|placebo|placebo consisting of an equicaloric amount of maltodextrin with the same flavour and appearance as for the intervention product
16067311|NCT02402595|Drug|AVP-923|
16067312|NCT02402595|Drug|AVP-786|
16067313|NCT02402595|Drug|Itraconazole|
16067314|NCT02402582|Other|Family-centered empowerment model|FCEM and Control groups had similar inpatient care. Patients in the intervention group received care employing the FCEM in four stages. Stage 1: Awareness and cognition. During 3-5 group sessions they were evaluated for their insight into their perceived illness severity and perceived sensitivity, or the degree to which they felt threatened by their illness. Stage 2: Expectations. 3-5 sessions. Stage 3: Acceptance. Assessed using an educational participation method in group discussion. Stage 4: Formative summative evaluations. The formative evaluation encourages patients to internalize their locus of control by seeing his/her self-empowerment (increasing self-responsibility about their health). Summative evaluations were performed to evaluate the influence of the intervention on HRQoL dimensions, perceived stress and anxiety -- assessed at baseline and at 3 months post-intervention. Empowerment was measured at baseline and at 10 days post-intervention by deploying FCEM questionnaires.
16067315|NCT02402582|Other|Control|FCEM and Control groups had similar inpatient care. Upon discharge the Control group underwent routine care and follow-up.
16067316|NCT02402569|Device|32 channels Deep Brain Stimulator|
16067317|NCT02402556|Behavioral|MOCEP|Through parent support and an evidence-based curriculum, MOCEP uses education to reduce risk factors that hinder children's health and wellbeing.
16067318|NCT02402543|Drug|Gabapentin|
16067319|NCT02402543|Drug|Ketamine|Prior to the incision in the operating room, the anesthesiologist administers 0.15 mg/kg of ketamine IV push in patients randomized to the experimental arm, only.
16067320|NCT02402543|Drug|Acetaminophen|
16067321|NCT02402543|Drug|Dexamethasone|Prior to the incision in the operating room, the anesthesiologist administers 8 mg of dexamethasone IV push in patients randomized to the experimental arm, only.
16067322|NCT02402543|Drug|Placebo|
16067323|NCT02402530|Drug|Placebo|Matching placebo administered as intravenous infusion.
16067324|NCT02402530|Drug|Neridronic acid 62.5 mg|Neridronic acid administered as intravenous infusion.
16067325|NCT02402517|Other|Control|Non pulse extruded snack
16067326|NCT02402517|Other|Small particle size pea flour|Pulse extruded snack
16067327|NCT02402517|Other|Large particle size pea flour|Pulse extruded snack
16067328|NCT02402517|Other|Lentil flour|Pulse extruded snack
16067329|NCT02402517|Other|Navy bean flour|Pulse extruded snack
16067330|NCT02402517|Other|Pinto bean flour|Pulse extruded snack
16067331|NCT02402504|Other|Control|Non pulse extruded snack
16067332|NCT02402504|Other|Small particle size pea flour|Pulse extruded snack
16067333|NCT02402504|Other|Large particle size pea flour|Pulse extruded snack
16067334|NCT02402504|Other|Lentil flour|Pulse extruded snack
16067335|NCT02402504|Other|Navy bean flour|Pulse extruded snack
16067336|NCT02402504|Other|Pinto bean flour|Pulse extruded snack
16067337|NCT02402491|Drug|12 months of P2Y12 receptor antagonist|All subjects will be received 12 months of dual antiplatelet therapy with a P2Y12 receptor antagonist (clopidogrel/prasugrel/ticagrelor) in addition to aspirin.
16067338|NCT02402491|Drug|24 months of P2Y12 receptor antagonist|All subjects will be received 24 months of dual antiplatelet therapy with a P2Y12 receptor antagonist (clopidogrel/prasugrel/ticagrelor) in addition to aspirin.
16067339|NCT02402491|Drug|Aspirin|The maintenance dose of aspirin is 100 mg daily, to be taken indefinitely.
16067340|NCT02402465|Drug|Placebo|Patients will be treated by placebo
16067341|NCT02402465|Drug|Fluticasone propionate|Patients will receive fluticasone nasal spray
16067342|NCT02402465|Drug|Fluticasone/Azelastine nasal spray|Patients will receive Dymista nasal spray
16067343|NCT02402465|Procedure|Nasal Allergen Challenge|All subjects will receive a nasal challenge with allergen to mimick an allergic response and allow the investigation of the different drug effects on that response. Allergen extracts will be used as sprays into the nasal cavity. The extracts are approved by FDA for skin testing or desensitization therapy and an IND was obtained to allow intranasal administration
16067344|NCT02402452|Drug|Voxilaprevir|100 mg tablet administered orally
16067345|NCT02402439|Drug|Islet cells|Transplantation of islets into the gastrointestinal submucosa
16067485|NCT02401425|Other|Placebo|
16067348|NCT02402413|Procedure|Determination of concentrations of androgens|Determination of concentrations of serum levels of circulating androgens
16067349|NCT02402413|Device|Three dimensional ultrasound probe|Capture of ovarian three dimensional volumes
16067350|NCT02402400|Drug|Sub Lingual Ticagrelor|180mg sub-lingual ticagrelor
16067351|NCT02402387|Procedure|Neutral head position|
16067352|NCT02402387|Procedure|Flexed head position|
16067353|NCT02402387|Procedure|Extended head position|
16067354|NCT02402387|Procedure|Rotated head position|
16067355|NCT02402387|Device|Air-Q SP Airway|
16067356|NCT02402374|Device|Autologous platelet rich plasma gel|PRP gel application to exuding wounds, such as leg ulcers, pressure ulcers, and diabetic foot ulcers and for the management of mechanically- or surgically-debrided wounds
16067357|NCT02402374|Device|Placebo|Placebo control arm will be receiving commercial formulations of pre-prepared saline gel.
16067358|NCT02402348|Drug|Metformin|
16067359|NCT02402322|Behavioral|Scheduled support|Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone weekly.
16067360|NCT02402322|Behavioral|Non-scheduled support|Participants followed the online self-help program based on cognitive behavioral therapy for 8 weeks. They had the support of a therapist via phone when they required it.
16067361|NCT02402309|Drug|Active topical NS2 1% dermatologic cream|
16067362|NCT02402309|Drug|Vehicle placebo 0.0% NS2 dermatologic cream|
16067363|NCT02402296|Drug|β-1,3/1,6-D-glucan|15 patients (in group II) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of β-1,3/1,6-D-glucan oral supplementation for 40 days.
16067364|NCT02402296|Other|Placebo|15 patients (in group I) suffering from localized aggressive periodontitis followed a strict plaque control program (within two weeks); followed by a systemic course of placebo capsules oral supplementation for 40 days.
16067365|NCT02402283|Drug|Metronidazole benzoate oral granules|Single oral dose of 400 mg
16067366|NCT02402283|Drug|Flagyl 400 mg Tablets|Single oral dose of 400 mg
16067367|NCT02402270|Drug|NuLYTELY® (PEG 3350)|
16067368|NCT02402270|Drug|ECP-019|
16067369|NCT02402270|Drug|MoviPrep® (PEG 3350)|
16067370|NCT02402257|Behavioral|CVC Train the Trainer|Trainees receive a simulation-based mastery learning intervention and train-the-trainer program on central venous catheter insertion
16067373|NCT02402231|Drug|Omalizumab|Omalizumab is the treatment during oral immunotherapy with peanuts as protection
16067374|NCT02402218|Other|Usual care plus peer-mentors|Participants are assigned a peer mentor for support before and after treatment for HCV with Harvoni.
16067375|NCT02402218|Other|Usual care plus incentives|Participants are given incentives after completing treatment goals.
16067376|NCT02402218|Other|Usual Care|Participants receive standard of care in the clinic from their health care team.
16067377|NCT02402205|Behavioral|TF-CBT|Web TF-CBT implementation or Web + Live TF-CBT implementation
16067378|NCT02402192|Drug|Corifollitropin alfa|
16067379|NCT02402179|Other|Tryptophan|Tryptophan will be supplied at 13.2, 26.4, 39.7, or 52.9% of requirement; sourced from crystalline amino acid and white cornmeal maize.
16067380|NCT02402166|Drug|SPD489|All subjects will begin with 5mg of SPD489 daily and will be titrated until optimal dose is reached (5, 10, 15, 20, and 30mg)
16067381|NCT02402153|Device|Hyposafe device|Subcutaneous EEG recorder for EEG measurements
16067382|NCT02402140|Other|Pharmaceutical Intervention|Patients allocated to group 1, with pharmaceutical intervention, received instructions on the proper use of immunosuppressants as doses, frequency, importance, schedules on the following days 3, 5, 7, 10, 14, 21, 28, 60 and 90 after kidney transplant. Teaching materials were designed to assist in the pharmaceutical guidelines that understood the importance of immunosuppressive drugs, the risk of rejection, the schedules and the most appropriate way for the administration. In addition to these guidelines, pharmacists helped patients in filling out the patient diary. This diary contains all the medications that the patient administers and encourages them to write down daily doses in order to remind them. This was a standardized pharmacist intervention.
16067383|NCT02402127|Device|Narafilcon A contact lenses|Silicone hydrogel contact lenses for daily disposable wear
16067384|NCT02402127|Device|Stenfilcon A contact lenses|Silicone hydrogel contact lenses for daily disposable wear
16067385|NCT02402127|Device|Somofilcon A contact lenses|Silicone hydrogel contact lenses for daily disposable wear
16067386|NCT02402114|Drug|Hydrocortisone|120 mg Hydrocortisone given orally one time.
16067387|NCT02402101|Device|Procedure: active tDCS|Intensity 2 mA during 20 minutes
16067388|NCT02402101|Device|Procedure: sham tDCS|sham condition as delivered by the stimulator
16067389|NCT02402088|Behavioral|Stress Imagery|"The stress imagery script will be based on subjects' description of a recent personal stressful event that they had experienced as most stressful. Most stressful is determined by having the subjects rate the perceived stress experienced by them on a 10-point Likert scale where 1=not at all stressful and 10=the most stress they felt recently in their life. Only situations rated as 8 or above on this scale are accepted as appropriate for script development. Examples of acceptable stressful situations include breakup with significant other, a verbal argument with a significant other or family member or unemployment-related stress, such as being fired or laid off from work."
16067390|NCT02402088|Behavioral|Food Cue Imagery|A food cue script will be developed from the subjects' experience of eating their most favorite foods. Examples include ordering pizza, cooking a favorite meal, or going out to a restaurant.
16067391|NCT02402088|Behavioral|Neutral-Relaxing|A neutral-relaxing script will be developed from the subjects' commonly experienced neutral-relaxing situations, such as a trip to the beach or park.
16067392|NCT02402062|Drug|TH-302 + Sunitinib|"Combination of the two drugs in cycles of 28 days, described as follows:
~Sunitinib: 37,5 mg/day Oral everyday of each 28 day cycle.
~TH-302: 340 mg/m2 IV on days 8, 15 and 22 of each cycle."
16067393|NCT02402049|Drug|Natrum muriaticum 30C|3 globules of Natrum muriaticum applied once daily at days 7,8, and 9 after the start of the period.
16067394|NCT02402049|Drug|Lachesis 30C|3 globules of Lachesis applied once daily at days 7,8, and 9 after the start of the period.
16067395|NCT02402049|Drug|Sepia 30C|3 globules of Sepia applied once daily at days 7,8, and 9 after the start of the period.
16067396|NCT02402049|Drug|Nux vomica 30C|3 globules of Nux vomica applied once daily at days 7,8, and 9 after the start of the period.
16067397|NCT02402049|Drug|Pulsatilla 30C|3 globules of Pulsatilla applied once daily at days 7,8, and 9 after the start of the period.
16067398|NCT02402049|Drug|Folliculinum 30C|3 globules of Folliculinum applied once daily at days 7,8, and 9 after the start of the period.
16067399|NCT02402049|Drug|Placebo Natrum muriaticum|3 globules of placebo Natrum muriaticum applied once daily at days 7,8, and 9 after the start of the period.
16067400|NCT02402049|Drug|Placebo Lachesis|3 globules of placebo Lachesis applied once daily at days 7,8, and 9 after the start of the period.
16067401|NCT02402049|Drug|Placebo Sepia|3 globules of placebo Sepia applied once daily at days 7,8, and 9 after the start of the period.
16067402|NCT02402049|Drug|Placebo Nux vomica|3 globules of placebo Nux vomica applied once daily at days 7,8, and 9 after the start of the period.
16067403|NCT02402049|Drug|Placebo pulsatilla|3 globules of placebo Pulsatilla applied once daily at days 7,8, and 9 after the start of the period.
16067404|NCT02402049|Drug|Placebo Folliculinum|3 globules of placebo Folliculinum applied once daily at days 7,8, and 9 after the start of the period.
16067405|NCT02402036|Drug|Regorafenib|Regorafenib orally for 21 days every 28 day cycle
16067406|NCT02402023|Behavioral|Contingency Management (CM)|CM is standard care plus monetary payment delivered contingent on abstinence.
16067407|NCT02402023|Behavioral|Standard of Care (SC)|Standard of care consists of smoking cessation counseling sessions and nicotine patches.
16067408|NCT02402010|Behavioral|Adjunctive Yoga|
16067409|NCT02402010|Behavioral|Enhanced Treatment as Usual|
16067410|NCT02401997|Behavioral|sexual abstinence|The subjects participated in the study are divided into three groups according to the male partners sexual abstinence period during the day of sperm preparation for intrauterine insemination.
16067411|NCT02401984|Other|Screening|Participants will fill out a short screening questionnaire where different aspects of mental health and behavioral problems will be assessed.
16067412|NCT02401971|Drug|Thalidomide|Given orally
16067413|NCT02401971|Drug|CPT-11|Given Ivgtt
16067414|NCT02401958|Other|Resistance training|17 volunteers with RA and 17 without the disease, with a mean age of 54.7 + 6.63 underwent a resistance exercise session with a set of 12 repetitions at 50% of one repetition maximum (1RM ) and a set of 8 repetitions at 75% of 1RM. The exercises performed were: knee extension, knee flexion, hip abduction and hip adduction. Blood samples were obtained 30 minutes before, 5 minutes before, immediately after, 1 hour, 2 hours and 24 hours after the exercise session.
16067415|NCT02401945|Drug|DE-120|
16067416|NCT02401945|Drug|Aflibercept|
16067417|NCT02401932|Other|Hemophagocytosis|Best supportive care and immunosuppressive treatments
16067418|NCT02401919|Behavioral|Tell-us Card|Patients will be invited on a daily basis, during their stay in the hospital, to state what is important for them at that moment or before discharge
16067419|NCT02401906|Other|MRI|
16067420|NCT02401893|Biological|Influenza Vaccine|Everyone immunized as recommended by current guidelines
16067421|NCT02401880|Drug|Linagliptin|22 subjects will receive Linagliptin for 30 days
16067422|NCT02401880|Other|Placebo|22 subjects will receive Placebo for 30 days
16067423|NCT02401880|Drug|Empagliflozin|44 subjects will receive Empagliflozin for 60 days
16067424|NCT02401841|Drug|Two different types of drug for resolution of neuro-muscular blockade|
16067425|NCT02401828|Drug|Dolutegravir|Switch from combination antiretroviral therapy to dolutegravir monotherapy
16067426|NCT02401815|Drug|PLX9486|PLX9486 will be administered per dose and schedule specified in the arm.
16067427|NCT02401815|Drug|Pexidartinib|Pexidartinib capsules will be administered per dose and schedule specified in the arm.
16067428|NCT02401815|Drug|Sunitinib|Sunitinib will be administered per dose and schedule specified in the arm.
16067429|NCT02401802|Dietary Supplement|Low-residue diet|Subjects will be instructed by members of the research team to follow a standardized low residue diet for 4 days
16067430|NCT02401802|Dietary Supplement|Usual care|Subjects will be instructed by members of the research team to follow a low-residue diet for 3 days followed by 24 hours of liquid diet
16067431|NCT02401789|Device|Implants (OsseospeedTM,EV Astra Tech System, DentsplyTM, Mölndal)|
16067432|NCT02401776|Dietary Supplement|Monster Energy Drink|Small Dose of Monster energy drink. This will be given at a dose of 2mg caffeine/kg body weight (equivalent to approximately one 16 ounce can of monster energy drink for a person weighing 75 kg).
16067433|NCT02401776|Dietary Supplement|Monster energy drink|Medium Dose of Monster Energy Drink. This will be given at a dose of 3 mg caffeine/kg body weight (equivalent to approximately one 24 ounce can of monster energy drink for a person weighing 75 kg).
16067434|NCT02401776|Dietary Supplement|Monster Energy Drink|Monster energy drink. This will be given at a dose of 3mg caffeine/kg body weight (equivalent to approximately one 24 ounce can of monster energy drink for a person weighing 75 kg).
16067435|NCT02401776|Dietary Supplement|Coffee|Coffee. This will be given at a dose of 2mg caffeine/kg body weight (equivalent to approximately one 8 ounce cup of coffee drink for a person weighing 75 kg).
16067436|NCT02401750|Drug|Oxycodone Naltrexone (a)|
16067437|NCT02401750|Drug|Oxycodone Naltrexone (b)|
16067438|NCT02401750|Drug|Placebo|Matches both experimental drugs
16067439|NCT02401737|Drug|NVR 3-778|
16067440|NCT02401737|Drug|Placebo for NVR 3-778|Sugar pill manufactured to mimic the NVR 3-778 capsule
16067441|NCT02401737|Drug|Pegasys|
16067442|NCT02401724|Other|Transcranial direct current stimulation|
16067443|NCT02401724|Other|Action Training|
16067486|NCT02401412|Device|Test Ostomy Barrier|
16067487|NCT02401412|Device|Control Ostomy Barrier|
16067488|NCT02401399|Dietary Supplement|Regular diet|The patients receive regular diet 900 Kcal/day during 15 days before surgery
16067489|NCT02401399|Dietary Supplement|High protein formula|The patients receive high protein formula during 15 days before surgery
16067444|NCT02401711|Behavioral|Education - BIPS course|The guiding principles behind the BIPS program include: (1) explaining how complex systems cause human error and how human error can lead to patient harm in complex systems; (2) diagnosing human error and identifying a prevention behavior for each of the three types: skill, rule, and knowledge; and (3) preventing error by promoting safety behaviors, such as having attention to detail, communicating clearly, having a questioning attitude, and speaking up for safety
16067445|NCT02401711|Behavioral|Formal safety curriculum|The educational program is designed to improve patient safety by informing residents about safe operating room behaviors.
16067446|NCT02401711|Behavioral|Ongoing evaluation and feedback|The feedback program is designed to encourage the use of safe behaviors and to discourage unsafe behaviors taught in the workshops.
16067447|NCT02401698|Other|Functional clinical and TMS diagnostic|Functional clinical and TMS diagnostic examination to evaluate corticospinal motor tract activity and corticocerebellar tract activity and its relation with stroke recovery
16067448|NCT02401685|Other|Adjuvant therapy|Adjuvant therapy will include chemotherapy and/or endocrine therapy for all women, and radiotherapy to breast or chest wall if indicated. Human epidermal growth factor receptor 2 (HER2) targeted treatment may also be administered when indicated.
16067449|NCT02401685|Procedure|Axillary treatment|Axillary treatment can be axillary node clearance or axillary radiotherapy as per local guidelines.
16067450|NCT02401672|Device|Transcranial magnetic stimulation|Transcranial magnetic stimulation (TMS) is a noninvasive (and relatively painless) brain stimulation technology that can focally stimulate the brain of an awake individual. A localized pulsed magnetic field transmitted through a TMS coil is able to focally stimulate the cortex by depolarizing superficial neurons inducing electrical currents in the brain. If TMS pulses are delivered repetitively and rhythmically, the process is called repetitive TMS (rTMS).
16067451|NCT02401659|Device|CareLinK|
16067452|NCT02401646|Dietary Supplement|Polygoni Multiflori Radix complex extract|Intervention is manufactured by Chun-Ho food
16067453|NCT02401646|Dietary Supplement|Placebo|The placebo is filled with starch, so does not contain the active ingredient.
16067454|NCT02401633|Procedure|CO-CPR|CPR provided by bystander with chest-compressions only
16067455|NCT02401633|Procedure|S-CPR|CPR with Chest Compressions and Rescue Breaths in a ratio of 30:2
16067456|NCT02401607|Other|Karasek questionnaire and Saliva prelevement|Karasek questionniare and Saliva collection will be assessed on any health care worker working in any emergency department in France at day 1 and at 5 years
16067457|NCT02401594|Drug|Rivaroxaban|10 mg once daily of Rivaroxaban active substance (10 mg tablet) plus a placebo syringe of enoxaparin 4000 UI once daily
16067458|NCT02401594|Drug|Enoxaparin|A syringe of enoxaparin active substance 4000 UI once daily plus a placebo tablet of Rivaroxaban 10 mg.
16067459|NCT02401581|Other|Catheter|The effectiveness of this model of management is defined by absence of a need for re-catheterization in the post -operative period of 24 hours, indications for resondage being cases of acute urinary retention (AUR ) or macroscopic hematuria necessitating a washes with drainage . Patients are followed for a period of 3 months with a post-operative visit at 30 days and a last follow-up visit at 90 days during which the effectiveness is evaluated by conventional means of clinical indicators ( flowmetry , postvoid residue, volumetry of the prostate , IPSS scores , QoL , EVA, IIEF ... ).
16067460|NCT02401568|Device|Dynamic CT|Various low dose CT acquisitions will be successively performed on the wrist to allow a four dimensional evaluation. The same type of acquisition will be performed during various manoeuvers (radio-ulnar deviation, clenching fist, and dart-throwing motion).
16067461|NCT02401568|Procedure|Arthrography|percutaneous intra-articular injection of contrast media in the medio-carpal and radio-carpal joints
16067462|NCT02401555|Device|Geenius HIV1/2 Supplemental Assay|The purpose of this study is to evaluate the performance of the Bio-Rad Geenius HIV1/2 Supplemental Assay test in finger stick whole blood, venous whole blood, serum or plasma (EDTA, heparin, sodium citrate).
16067463|NCT02401542|Drug|Vofatamab|
16067464|NCT02401542|Drug|Docetaxel|
16067465|NCT02401542|Drug|Placebo|
16067466|NCT02401529|Drug|IV dexamethasone|0.15 mg/kg
16067467|NCT02401529|Drug|Oral prednisolone|0.25mg/kg/day for 7 days then tapering for next 7 days
16067468|NCT02401529|Drug|Paracetamol|acetaminophen 15 mg/kg/dose every 6 hours
16067469|NCT02401529|Drug|IV saline|IV saline
16067470|NCT02401516|Device|Reprogramming insoles|1)Answer demographic, lifestyle and health questionnaire; 2)Weight and height evaluation; 3)ABPM (Ambulatory Blood Pressure Monitoring) and diary of activities assessment; 4)Postural Assessment software (SAPO), created by São Paulo's University (USP), which assesses posture through full body images of people with marked bone prominences on the body in all planes of motion. Images are captured by a Sony Cybershot 14 Megapixel camera, supported on a tripod, placed three meters away from the subject and at half its height. 5)Six-Minutes Walk Test in accordance with Britto and Souza25 and American Thoracic Society guidelines43; 6)analog manometer Globalmed® brand to assess respiratory muscle strength; 7)Dynamometer Jamar® brand to measure grip strength; 8)Wells bank to evaluate Flexibility.
16067471|NCT02401503|Drug|Bendamustine|Debulking: Cycles 1-2, d1 & 2: 70mg/m² i.v.
16067472|NCT02401503|Drug|GA101|Induction: Cycle 1: d1: 100mg, d1(or 2): 900mg, d8 & 15: 1000mg; Cycle 2-6: d1: 1000mg Maintenance: Cycles 1-8 (Duration 12 weeks): d1: 1000mg
16067473|NCT02401503|Drug|ABT-199|Induction: Cycle 2: d1-7: 20mg, d8-14: 50mg, d15-21: 100mg, d22-28: 200mg; Cycle 3-6: d1-28: 400mg Maintenance: Cycles 1-8 (Duration 12 weeks): d1-84: 400mg
16067474|NCT02401490|Drug|Human albumin|1.5gr/Kg/day at least in the 24-48 hours after the hospitalization and 1.0 gr/Kg/day at 72 hours after the first dose.
16067475|NCT02401490|Drug|Placebo|
16067476|NCT02401477|Drug|Ilaprazole + Amoxicillin|Ilaprazole 40mg BID, dosage form : delayed release tablet Amoxicillin 750mg QID, dosage form : capsule
16067477|NCT02401464|Drug|TAK-536 Tablet|TAK-536 10 mg tablet
16067478|NCT02401464|Drug|TAK-536 Dry Syrup Formulation|TAK-536 dry syrup formulation
16067479|NCT02401464|Drug|TAK-536 Ganule Formulation|TAK-536 granule formulation
16067480|NCT02401451|Device|RhythmPadGP|ECG acquisition using a novel device RhythmPadGP
16067481|NCT02401438|Other|5D ultrasound|
16067482|NCT02401438|Other|2D ultrasound|
16067483|NCT02401425|Drug|Letrozole|
16067484|NCT02401425|Drug|Misoprostol|
16067490|NCT02401399|Dietary Supplement|Immunonutrition|The patients receive Immunonutrition formula during 15 days before surgery
16067491|NCT02401386|Behavioral|The Eight Brocades|Patients received closely supervised, group-format EB program and practiced EB revised by Chinese Medicine Master Zhi-zheng Lu for one hour, twice weekly for 12 weeksmovements, a review of principles, and breathing techniques in EB. Participants will be asked to practice EB at home for at least 16 minutes each day which is how long it takes to complete an EB exercise, using an instructional Digital Video Disc. The program will be taught by experienced EB masters.
16067492|NCT02401373|Biological|Ad5-EBOV|intramuscular injection
16067493|NCT02401360|Drug|China Crest® Pro-health 7 Complete Toothpaste|Crest® pro-health manual toothbrush Crest® pro-health gum protection rinse
16067494|NCT02401360|Drug|China Crest® Cavity Protection Toothpaste|Crest® meliliangje manual toothbrush
16067495|NCT02401347|Drug|Talazoparib Tosylate|Participants receive Talazoparib tosylate at 1 mg by mouth daily.
16067496|NCT02401334|Device|Cook® Antimicrobial Hernia Repair Device|Device containing an antimicrobial to reinforce soft tissue during ventral or incisional hernia repair in clean-contaminated, contaminated, and dirty-infected
16067497|NCT02401321|Behavioral|Telephone-Based Intervention|Complete Taking Care of Her program
16067498|NCT02401321|Other|Caregiver-Assisted Training|Complete Taking Care of Her program
16067499|NCT02401321|Other|Questionnaire Administration|Ancillary studies
16067500|NCT02401321|Other|Quality-of-Life Assessment|Ancillary studies
16067502|NCT02401295|Drug|ATRA|
16067503|NCT02401295|Drug|Celecoxib|
16067504|NCT02401295|Drug|Itraconazole|
16067505|NCT02401282|Behavioral|Attention Bias Modification|This is a modification of the dot-probe task (placebo task) designed to train attention away from threat
16067506|NCT02401282|Behavioral|Dot-probe task|This is the active control placebo condition that simply measures levels of attention to threat
16067507|NCT02401269|Drug|Aspirin|
16067508|NCT02401269|Drug|Placebo|
16067509|NCT02401256|Drug|Efavirenz|"The study has 4 phases:
~Phase 1 (control)-Subjects will receive simultaneously a single dose of bupropion 100 mg, montelukast 10 mg and rosuvastatin 5 mg (cocktail) by mouth (control).
~Phase 2 (inhibition)- a single 600 mg oral dose of efavirenz (blood draw at 30 min and 1 hour) will be administered with the cocktail drugs.
~Phase 3 (home treatment with efavirenz): Subjects will take efavirenz at home (600 mg/day for 17 days).
~Phase 4 (Induction) - is the same as phase 2. Blood samples (0 to 120 hrs) and urine voided over 48 hrs (Phases 1, 2 and 4) are collected. Blood draws will be made in phase 3 for trough concentration measurements."
16067510|NCT02401256|Drug|Bupropion|"The study has 4 phases:
~Phase 1 (control)-Subjects will receive simultaneously a single dose of bupropion 100 mg, montelukast 10 mg and rosuvastatin 5 mg (cocktail) by mouth (control).
~Phase 2 (inhibition)- a single 600 mg oral dose of efavirenz (blood draw at 30 min and 1 hour) will be administered with the cocktail drugs.
~Phase 3 (home treatment with efavirenz): Subjects will take efavirenz at home (600 mg/day for 17 days).
~Phase 4 (Induction) - is the same as phase 2. Blood samples (0 to 120 hrs) and urine voided over 48 hrs (Phases 1, 2 and 4) are collected. Blood draws will be made in phase 3 for trough concentration measurements."
16067511|NCT02401256|Drug|Rosuvastatin|"The study has 4 phases:
~Phase 1 (control)-Subjects will receive simultaneously a single dose of bupropion 100 mg, montelukast 10 mg and rosuvastatin 5 mg (cocktail) by mouth (control).
~Phase 2 (inhibition)- a single 600 mg oral dose of efavirenz (blood draw at 30 min and 1 hour) will be administered with the cocktail drugs.
~Phase 3 (home treatment with efavirenz): Subjects will take efavirenz at home (600 mg/day for 17 days).
~Phase 4 (Induction) - is the same as phase 2. Blood samples (0 to 120 hrs) and urine voided over 48 hrs (Phases 1, 2 and 4) are collected. Blood draws will be made in phase 3 for trough concentration measurements."
16067512|NCT02401256|Drug|Montelukast|"The study has 4 phases:
~Phase 1 (control)-Subjects will receive simultaneously a single dose of bupropion 100 mg, montelukast 10 mg and rosuvastatin 5 mg (cocktail) by mouth (control).
~Phase 2 (inhibition)- a single 600 mg oral dose of efavirenz (blood draw at 30 min and 1 hour) will be administered with the cocktail drugs.
~Phase 3 (home treatment with efavirenz): Subjects will take efavirenz at home (600 mg/day for 17 days).
~Phase 4 (Induction) - is the same as phase 2. Blood samples (0 to 120 hrs) and urine voided over 48 hrs (Phases 1, 2 and 4) are collected. Blood draws will be made in phase 3 for trough concentration measurements."
16067513|NCT02401243|Drug|INSULIN GLARGINE (U300)|"Pharmaceutical form: pre-filled disposable pen
~Route of administration: subcutaneous"
16067514|NCT02401230|Drug|Truvada|Truvada is a combination of 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate taken orally.
16067515|NCT02401230|Device|Gel lubricant|Five ml of an over the counter sexual lubricant will be dispensed using an applicator.
16067516|NCT02401217|Other|Phase 1- Arm 1 Infant Formula|Powder infant formula
16067517|NCT02401217|Other|Phase 2- Arm 2 Infant Formula|Powder infant formula
16067518|NCT02401217|Other|Phase 2- Arm 3 Infant Formula|Powder infant formula
16067519|NCT02401204|Other|Longitudinal surveillance study|"Regular specimens will be routinely collected as standard of practice.
~A rectal swab and stool specimen will be collected twice a week since first admission on NICU until discharge from NICU.
~If participant is intubated/ventilated, a throat swab will be collected."
16067520|NCT02401191|Drug|FEX60/PE10|Pharmaceutical form:tablet Route of administration: oral
16067521|NCT02401165|Other|Blood test|blood test
16067522|NCT02401152|Other|Sports drink 1|Sports drink with a specific source of CHO.
16067523|NCT02401152|Other|Sports drink 2|Sports drink with a specific source of CHO
16067524|NCT02401152|Other|Placebo|iso-caloric sports drink with maltodextrin as CHO source
16067525|NCT02401139|Drug|Ketamine|
16067526|NCT02401139|Drug|Placebo|
16067527|NCT02401126|Dietary Supplement|Nitrate supplementation|Nitrate supplementation: concentrated nitrate-rich beetroot juice (2 x 70 ml/day; approximately 10 mmol nitrate/day; Beet It, James White Drinks, Ipswich, UK) for 8 consecutive days.
16067528|NCT02401126|Dietary Supplement|Placebo|Placebo: nitrate-depleted beetroot juice (2 x 70 ml/day; approximately 0.01 mmol nitrate/day; Beet It, James White Drinks, Ipswich, UK) for 8 consecutive days. The placebo juice is similar to the concentrated beetroot juice in appearance, texture, smell and taste and is obtained by removing nitrate ions from the latter.
16067529|NCT02401113|Dietary Supplement|UA group|Ursolic Acid of Loquat Extract, 500mg/ day during 12 weeks
16067530|NCT02401087|Procedure|Anaesthesiological procedure|
16067531|NCT02401074|Biological|Segmental Bronchoprovocation with Allergen (SBP-Ag)|Premedication will consist of intramuscular glycopyrolate (0.2 mg), and midazolam (0.5-2.0 mg). Subjects will also be given a short-acting beta agonist, albuterol (2 puffs, 180 mcg) prior to bronchoscopy. Following nasopharyngeal anesthesia (topical lidocaine), the fiberoptic bronchoscope will then be passed into a pulmonary segment or subsegment. During the SBP-Ag challenge, approximately 15% of the Ag-PD20 allergenic extract will be instilled into the segment (5)
16067532|NCT02401061|Drug|PRTX-100|Four weekly infusions of PRTX-100 at a level of 1 (3, 6,12, 18, or 24) microgram of PRTX-100 per kilogram of patient weight, infused over 30 minutes, followed by four hours of observation.
16067533|NCT02401048|Drug|Ibrutinib|
16067534|NCT02401048|Drug|MEDI4736|
16067535|NCT02401035|Drug|IV pantoprazole|Patients will receive 10 mg, 20 mg, or 40 mg IV pantoprazole determined by weight
16067536|NCT02401022|Drug|AZD8529|comparison of different dosages of drug
16067537|NCT02400983|Device|Pacemaker, ICD|
16067538|NCT02400970|Other|malignant cells|
16067539|NCT02400957|Other|Silver nanoparticles|Half of the mouth was applied silver nanoparticles. Allocation was randomized. Evaluate the effectiveness of silver nanoparticles incorporated into the primer orthodontic Transbond XT in preventing enamel demineralization adjacent to brackets.
16067540|NCT02400957|Other|Placebo|Half of the mouth was applied placebo. Allocation was randomized. Evaluate the effectiveness of silver nanoparticles incorporated into the primer orthodontic Transbond XT in preventing enamel demineralization adjacent to brackets.
16067541|NCT02400944|Behavioral|questionnaires|The study questionnaires (baseline and 2 follow-ups) will capture information on how modifiable factors, including the patients' smoking habits and body weight, have changed since last contact. RSA will conduct this interview at a time convenient to the patient either during a scheduled clinic visit or by telephone.
16067542|NCT02400944|Other|Saliva and/or urine sample|Patients will contribute approximately 5 mL of saliva at baseline, and at the time of their follow-up questionnaires. If the patient declines to contribute a saliva specimen, they can contribute approximately 10mL of urine. Urine is routinely collected from bladder cancer patients for clinically-related tests. We will also collect urine from every participant for whom the sample is not depleted by clinical tests at the end of the day. Saliva/urine specimens will be tested for cotinine which is regarded as the gold standard to detect recent smoking exposure and is widely used to identify active smokers in epidemiologic studies.
16067543|NCT02400931|Procedure|mask ventilation|In mask ventilation group, rocuronium of 0.6 mg/kg will be administered after the loss of consciousness. Mask ventilation wil be performed until there is no response on the train-of-four stimulus. No mask ventilation - In no mask ventilation group, rocuronium of 1.2 mg/kg will be administered after the loss of consciousness. Tracheal intubation will be performed after confirmation of no response on the train-of-four stimulus. The mask ventilation will not be performed before the tracheal intubation.
16067544|NCT02400931|Procedure|no mask ventilation|
16067545|NCT02400931|Drug|Rocuronium|
16067546|NCT02400918|Other|The Mindfulness and Acceptance-based Workbook for Social Anxiety and Shyness (Fleming & Kocovski, 2013)|An acceptance and commitment therapy-based self-help workbook for social anxiety and shyness. It includes an 8-week program.
16067547|NCT02400905|Device|BioMimics 3D Vascular Stent System|Femoropopliteal stenting
16067548|NCT02400892|Other|TTE Bubble Study|Bedside transthoracic echocardiogram bubble study to assess for the presence or absence of a PFO
16067549|NCT02400879|Drug|Remifentanil|administering remifentanil infusion 0.7-0.8 mcg/kg/min for anesthesia maintenance
16067550|NCT02400879|Drug|sevoflurane and sufentanil|administering sevoflurane and sufentanil for anesthesia maintenance
16067551|NCT02400866|Drug|Olanzapine|
16067552|NCT02400853|Device|Standard cranial echography|Standard cranial echography will be done at day 5 day 7 post-birth looking for radiological finding of intraventricular hemorrhage
16067553|NCT02400853|Procedure|Cord blood analysis|Cord blood will be collected during deliverance and analysed
16067554|NCT02400840|Procedure|cardiac MRI|Cardiac MRI is done using gadobenic acid intravenous injection 0.2 ml/kg one time
16067555|NCT02400840|Drug|gadobenic acid intravenous injection 0.2 ml/kg|gadobenic acid intravenous injection 0.2 ml/kg is used one time for cardiac MRI assessment
16067556|NCT02400827|Other|malignant cells|
16067557|NCT02400814|Drug|Anti-PD-L1 Monoclonal Antibody MPDL3280A|Given IV
16067558|NCT02400814|Radiation|Stereotactic Body Radiation Therapy|Undergo SAR
16067559|NCT02400801|Drug|triptorelin|gonadotropin-releasing hormone (GnRH) agonist
16067560|NCT02400801|Drug|ethinylestradiol + dienogest|oral oestroprogestogen
16067561|NCT02400788|Drug|Resminostat|
16067562|NCT02400788|Drug|Sorafenib|
16067563|NCT02400775|Drug|Azilsartan|Azilsartan tablets
16067564|NCT02400749|Drug|Apremilast|"Apremilast tablets will be provided to sites in blister cards.
~Patients will be provided a titration blister pack containing apremilast 10 mg, 20 mg and 30 mg at the Day 0 and week 16 visits (refer to section 6.1). Following the 6 day titration period (for Day 0 and week 16) blister packs will contain apremilast 30 mg bid or placebo bid."
16067565|NCT02400749|Drug|Placebo|Placebo tablets will be provided to sites in blister cards.
16067566|NCT02400736|Behavioral|Individual Placement and Support (IPS)|Individual Placement and Support (IPS) is the evidenced based model of supported employment.
16067567|NCT02400736|Other|Treatment as Usual Vocational Rehabilitation/Transitional Work (TUA-VR)|Vocational Rehabilitation Treatment as Usual includes pre-vocational counseling, Community Based Supported Employment, or most commonly Transitional Work assignments (TW).
16067568|NCT02400723|Behavioral|Progressive Muscle Relaxation|Progressive Muscle Relaxation is a treatment in which individuals tense and release their muscle groups in a sequential order. This helps reduce anxiety and tension. It also teaches individuals to differentiate between muscle tension and relaxation.
16067569|NCT02400723|Behavioral|Diaphragmatic Breathing|Diaphragmatic breathing is a way in which people breathe using their diaphragm. This type of breathing has been found to promote relaxation and reduce stress.
16067611|NCT02400424|Radiation|SBRT|54 Gy in 3 fractions D1-D3-D5. SBRT should be started within 3 to 4 weeks after the end of radiochemotheray (RT-CT).
16067570|NCT02400723|Other|Psychoeducation (Placebo)|DVD-delivered psychoeducation. Participants will view videos that contain information about what anxiety is and information about one's well-being. This condition is an attention placebo control.
16067571|NCT02400710|Behavioral|Clinician-Supported PTSD Coach|Brief primary care-based intervention provided by a mental health clinician who is located in primary care.
16067572|NCT02400710|Behavioral|Self-Managed PTSD Coach|One 10 minute session explaining how to use the PTSD Coach mobile app.
16067573|NCT02400697|Other|<30 wks gestation or 1500 grams|Outcomes of preterm infants recorded
16067574|NCT02400684|Biological|blood samples|Evolution of AMH before and after deep endometriosis surgery
16067575|NCT02400671|Behavioral|SMS messaging|
16067576|NCT02400658|Device|IORT with CT-Guided HDR Brachytherapy|This therapy targets the cancer cells directly, reducing the volume of breast tissue exposed to the radiation and the risks involved with the radiation. CT imaging will be used via a multichannel/multi-dwell balloon catheter to better sculpt the cancer away from the heart, skin, and ribs.
16067577|NCT02400645|Procedure|Pre-incisional wound infiltration|Intraoperative: Pre-incisional bupivacaine 0.25% up to 20 cc divided dose for trocar incisions
16067578|NCT02400645|Procedure|Laparoscope to place TAP block with liposomal bupivacaine|Intraoperative: Laparoscopic TAP block with Liposomal bupivacaine and bupivacaine 0.25%
16067579|NCT02400645|Drug|Liposomal bupivacaine|Use of Liposomal bupivacaine in laparoscopic TAP block
16067580|NCT02400645|Drug|Bupivacaine|20 cc Bupivacaine 0.25% plain will be used for either pre-incisional injection or added to laparoscopic TAP block solution.
16067581|NCT02400645|Drug|Ketorolac|Ketorolac 30mg to be given IV at end of surgical procedure unless contraindicated.
16067582|NCT02400632|Device|MAGIC-TOUCH Drug-eluting Balloon|in-stent restenosis treated with drug eluting balloon
16067583|NCT02400619|Device|shock waves|Swiss dolorclast smart EMS Registration: EN-60601-1 Type BF IP40. 93/42 CEE
16067584|NCT02400619|Drug|Botulinum Toxin Type A|Botulinum toxin type A Botox
16067585|NCT02400606|Other|Constructing VP cases|The participants were presented with a short case overview. The control group solved the cases, whereas the intervention group also received the final diagnosis and had to complete the history, physical findings, and lab results. After a week, participants completed a transfer test involving two standardized patients presenting a respiratory case and a cardiology case, respectively. Performances were video-recorded and subsequently assessed by two blinded raters using the Reporter-Interpreter- Manager-Educator (RIME) framework. Knowledge gains were assessed using a pre- and post-test of a 95-item Multiple-Response-Questionnaire (MRQ).
16067586|NCT02400606|Other|Solving VP cases|See above
16067587|NCT02400593|Behavioral|Meditation Workshop|Six weeks of formal instruction in Lovingkindness or Mindfulness meditation.
16067588|NCT02400580|Drug|IV acetaminophen|The patients in the treatment arm will receive 1000mg of IV acetaminophen.
16067589|NCT02400580|Drug|placebo|The patients in the placebo arm will receive normal saline.
16067590|NCT02400567|Drug|Fluorouracile|
16067591|NCT02400567|Drug|Epirubicin|
16067592|NCT02400567|Drug|Cyclophosphamide|
16067593|NCT02400567|Drug|Letrozole|
16067594|NCT02400567|Drug|Palbociclib|
16067595|NCT02400554|Behavioral|Yappalli|"Month 1-3: Up to 8 group sessions on Choctaw history, traditions, cultural systems, & women's roles. Up to 3 individual Motivational Interviewing (MI) sessions to identify community leadership & personal change goals on the main outcome.
~Month 2: Overnight Culture Camp to strengthen group cohesion & synthesize goals.
~Month 3: Walk for a week on the Choctaw Trail of Tears, upon completion make a commitment to conduct a community-wide event based on personal & leadership goals & experience on the Trail.
~Months 3-12: Up to 6 group meetings to plan community leadership events related to ATOD & obesity prevention. Includes: digital storytelling training to create a story related to ATOD & obesity prevention & an individual MI booster session to revise their personal & community leadership goals.
~Month 12: Share digital stories & community event experiences & undergo a ceremony to transition to health leaders within their communities."
16067596|NCT02400541|Behavioral|Cognitive remediation therapy|"Our scheme comprises 10 biweekly sessions ( 5 in group and 5 single) . Each session last about 45 minutes.
~Individual sessions will be held with the patient and a therapist trained in the CRT; group sessions will be led by two therapists trained in CRT and regroup the maximum 5 patients."
16067597|NCT02400541|Other|relaxation therapy|Our scheme comprises 10 biweekly sessions. Each session last about 45 minutes.
16067598|NCT02400528|Behavioral|quality of life questionnaires|
16067599|NCT02400515|Other|Exercise|This is a quasi-experimental study and the same group was evaluated before and after the exercise.
16067600|NCT02400502|Behavioral|I-CAT Therapy|I-CAT is a novel therapeutic intervention combining mindfulness and meditation strategies to improve stress reactivity and increase meaningful coping, as well as a range of possible proximal (e.g. autonomic, endocrine, immune indices of stress reactivity, symptom severity) and distal measures (function, relapse, quality of life). Participants meet weekly with a master's level clinician over the course of 20 weeks.
16067601|NCT02400476|Drug|Neratinib|
16067602|NCT02400476|Drug|Loperamide|
16067603|NCT02400476|Drug|Colestipol|2 g twice daily with or without food for one 28 day cycle
16067604|NCT02400476|Drug|Budesonide|9 mg extended release tablets once daily with or without food for 28 days
16067605|NCT02400463|Drug|Ruxolitinib|
16067606|NCT02400450|Dietary Supplement|Functional Ingredient Group|Participants will be provided with a mix of 6 study products to use over the 12 week trial (2 per day). These will be a) oatmeal, b) pancake mix, c) chocolate crunch bar, d) cranberry nut bar, e) anytime sprinkle, and f) smoothie mix, standardized for the content of functional ingredients.
16067607|NCT02400450|Dietary Supplement|Control Ingredient Group|The control group will receive a comparable set of food items to use over the 12 week trial (2 per day). These food items will contain an equivalent amount of calories per portion but without the additional functional ingredients.
16067608|NCT02400437|Drug|Ixazomib|Doses given on Days 1, 8, and 15 in induction and maintenance cycles.
16067609|NCT02400437|Drug|Dexamethasone|Doses given on Days 1, 8, and 15 in induction and maintenance cycles.
16067610|NCT02400437|Drug|Rituximab|Doses given on Day 1 of induction and maintenance cycles.
16067612|NCT02400411|Other|Wheat bread|
16067613|NCT02400411|Other|margarine|
16067617|NCT02400398|Other|Tube feeding|Jejunal or gastrojejunal tube feeds will be given as continuous feeds via pump with Peptamen (medical food), at the patient's home, for the duration of the protocol and as directed by the nutritionist.
16067618|NCT02400385|Drug|sunitinib|sunitinib 50mg/day po, 4 weeks on 2 weeks off
16067619|NCT02400385|Drug|nivolumab|nivolumab 3mg/kg IV ever 2 weeks
16067620|NCT02400372|Device|medihoney dressing|to evaluate the effect of medihoney dressing on the healing of split thickness skin graft donor site
16067621|NCT02400359|Drug|Lorcaserin HCl|Lorcaserin is a weight-loss drug developed by Arena Pharmaceuticals. It has serotonergic properties and acts as an anorectic.
16067622|NCT02400359|Drug|Placebo|This is a placebo oral pill that is a visual replica of the Lorcaserin medication but with no active ingredients.
16067623|NCT02400346|Drug|Adjunct brexpiprazole|"Weeks 1-4 titration from 0.5 up to 2 mg once daily, in weekly steps. For the rest of the 26 treatment weeks, maintenance with 1-3 mg once daily.
~Tablets for oral use once daily during 26 weeks. Tablet strengths: 0.5 mg, 1 mg, 2 mg and 3 mg."
16067624|NCT02400346|Drug|ADT|Citalopram, ecitalopram, fluoxetine, sertraline, paroxetine IR, paroxetine CR, venlafaxine IR, venlafaxine XR (extended release), desvenlafaxine, duloxetine, mirtazapine, agomelatine, bupropion; dosing according to label
16067625|NCT02400333|Drug|Ticagrelor OD tablet (90 mg single dose) administered with 200 ml of water|90 mg single dose
16067626|NCT02400333|Drug|Ticagrelor OD tablet (90 mg single dose) administered without water|90 mg single dose
16067627|NCT02400333|Drug|Ticagrelor OD tablet (90 mg single dose) suspended in water administered via nasogastric tube|90 mg single dose
16067628|NCT02400333|Drug|Brilique®, Ticagrelor IR tablet (90 mg) administered with 200mL of water|90 mg single dose
16067629|NCT02400320|Drug|Topical Spray|Topical spray containing Diclofenac 1.16%, Linseed Oil 3%, Menthol 5%, Methyl salicylate 10%.
16067630|NCT02400320|Drug|Topical Gel|Topical gel containing Diclofenac 1.16%, Menthol 5%, Methyl salicylate 10%
16067631|NCT02400320|Other|Saline|Saline
16067632|NCT02400307|Drug|Bictegravir|75 mg tablet administered orally
16067633|NCT02400294|Other|Toothbrushing|Toothbrushing associated with standard oral care in mechanically ventilated patients
16067634|NCT02400281|Drug|Crenolanib besylate|
16067635|NCT02400281|Drug|Idarubicin|
16067636|NCT02400281|Drug|Cytarabine|
16067637|NCT02400281|Drug|Azacytidine|
16067638|NCT02400281|Drug|Mitoxantrone|
16067639|NCT02400281|Drug|Etoposide|
16067640|NCT02400281|Drug|Fludarabine|
16067641|NCT02400281|Drug|G-CSF|
16067642|NCT02400268|Other|7 days course of antibiotic treatment|Standard antibiotic treatment approved for enterobacteraciae infections
16067643|NCT02400268|Other|14 days course of antibiotic treatment|Standard antibiotic treatment approved for enterobacteraciae infections
16067644|NCT02400255|Drug|Crenolanib besylate|
16067645|NCT02400242|Drug|ACY-241|Dose escalation up to 480 mg administered orally on Days 1-21 of a 28 day cycle.
16067646|NCT02400242|Drug|Pomalidomide|4 mg qd dosed on days 1-21 of a 28 day cycle
16067647|NCT02400242|Drug|Dexamethasone|40 mg qd on days 1, 8, 15, 22
16067648|NCT02400229|Procedure|Computed tomography angiography (cardiac CT)|Clinical management/treatment decisions based on cardiac computed tomography including coronary calcium scoring and coronary computed tomography angiography
16067649|NCT02400229|Procedure|Invasive coronary angiography (ICA)|Clinical management/treatment decisions based on invasive coronary angiography
16067650|NCT02400203|Other|Control|
16067651|NCT02400203|Other|Hemp foods|
16067652|NCT02400190|Other|endocrine therapy alone without radiotherapy|Patients will not receive radiotherapy, which is the current standard for treatment for their type of breast cancer.
16067653|NCT02400177|Behavioral|emotion regulation training|This is a workshop for parents that help them to understand how to deal with emotions generally and specifically with their ASD children's emotion
16067654|NCT02400164|Device|alfapump system|The Sequana Medical alfapump system is an implanted subcutaneous device with a rechargeable battery that moves ascitic fluid from the peritoneal cavity to the urinary bladder where it is eliminated by spontaneous diuresis.
16067655|NCT02400151|Drug|Vitamin D supplementation|Patients randomized to this group will receive 4000 UI of Vitamin D3 per day for 90 days.
16067656|NCT02400151|Drug|Placebo|Patients randomized to this group will receive placebo for 90 days.
16067657|NCT02400151|Other|3 months lifestyle and dietary management|Lifestyle and dietary management at the Saint Pierre Institute (Palavas-les-Flots, France) occurs for three months. Nutritionally speaking, each child or adolescent receives a controlled and balanced diet, consistent with the recommendations appropriate for his/her age, slightly hypocaloric or normocaloric. This dietary approach is complemented by a nutrition education program and supervision by a doctor and a dietician. Three hours of exercise training per week are scheduled; these sessions include adapted aerobic activities supervised by instructors and educators at the center.
16067658|NCT02400151|Other|Normal control|Patients in this group do not have experimental intervention in order to provide measures of a real-life control group.
16067659|NCT02400138|Other|Respiratory training|Respiratory training will include training of the inspiratory and expiratory muscle seven times per week over eight weeks, during 40 minutes, divided into two 20-min sessions (morning and afternoon). Each 20-min session comprised 4-min sets of respiratory training, followed by 1-min rest between the sets. The training program will be carried-out with the Orygen Dual Valve regulated at 50% of the subjects' maximal inspiratory and expiratory pressure values. Once a week, the treating physiotherapist performed a home visit, measured the current values of inspiratory and expiratory strength, and progressed the load to 50% of the new values.
16067660|NCT02400138|Other|Control|The control/sham group will underwent exactly the same protocol and weekly monitoring at home, but the participants will receive the devices without resistance of the spring.
16067661|NCT02400112|Drug|Vancomycin|Vancomycin powder administered locally, intraoperatively at site of open fracture
16067662|NCT02400099|Dietary Supplement|High-protein low calorie diet|
16067663|NCT02400099|Dietary Supplement|Control low calorie diet|
16067664|NCT02400099|Other|Anthropometrical measurements|
16067665|NCT02400099|Other|Body composition|
16067666|NCT02400099|Other|8-h metabolic profile|
16067668|NCT02400073|Device|AutoSet for Her|3 months nightly usage of the AutoSet for Her device
16067669|NCT02400060|Behavioral|Telephone-Based Intervention|Receive text messaging
16067670|NCT02400060|Other|Survey Administration|Ancillary studies
16067671|NCT02400060|Other|Laboratory Biomarker Analysis|Correlative studies
16067672|NCT02400047|Drug|Dexamethasone 0.2 mg/kg|Single injection of DXM (Mylan Dexamethasone® 20 mg/5 ml or 4 mg/1 ml injection ampoule solution) at 0.2 mg / kg after general anesthesia induction and before surgery incision.
16067673|NCT02400047|Drug|Dexamethasone 0.4 mg/kg|Single injection of DXM (Mylan Dexamethasone® 20 mg/5 ml or 4 mg/1 ml injection ampoule solution) at 0.4 mg / kg after general anesthesia induction and before surgery incision.
16067674|NCT02400047|Drug|Ketoprofen 1 mg/kg|Single injection of ketoprofen (Medac ketoprofen ® 100 mg/4 ml injection ampoule solution) at 1 mg /kg after general anesthesia induction and before surgery incision.
16067675|NCT02400034|Other|Voiding trial|1 of 2 tests to assess bladder function after midurethral sling surgery with and without anterior or posterior colporrhaphy
16067676|NCT02400021|Drug|Prometrium|
16067677|NCT02400008|Procedure|Surgery for bilateral laryngeal reinnervation|Surgery for bilateral laryngeal reinnervation assessed for patient with bilateral vocal fold paralysis
16067678|NCT02399995|Behavioral|HRQoL questionnaires.|"Questionnaires/Forms to be completed preoperatively in clinic with assistance from research study administrator:
~Baseline sociodemographic and clinical variable data sheet (RSA)
~EORTC QLQ-C30, QLQ-LMC21, EuroQoL EQ-5D-5L/VAS
~Baseline disease status and treatment assessment questionnaire Questionnaires/Forms to be completed at first postoperative clinic visit:
~EORTC QLQ-C30, QLQ-LMC21, EuroQoL EQ-5D-5L/VAS
~Questionnaires/Forms to be mailed to patients at ± 2 month window at the following time points 6,12,18,24, and 36 months following hepatectomy:
~EORTC QLQ-C30, QLQ-LMC21, EuroQoL EQ-5D-5L/VAS
~Post surgical follow up disease status and treatment assessment questionnaire
~At 8 weeks following the mailing of the initial questionnaire package if no response has been received, research personnel will attempt to contact participants by phone."
16067679|NCT02399982|Other|CBT-GSH|The treatment will be based on Overcoming Binge Eating. The treatment is divided into a user-friendly section on binge eating and a six-step self-help program. The first session will last 60 min, with each subsequent section lasting 20-25 minutes in length. Sessions are weekly over 3 months. Working with the therapist, participants will use the self-help guide to develop regular and moderate eating using selfmonitoring, problem solving, and other CBT techniques.
16067680|NCT02399982|Other|Noom Monitor|This treatment will be exactly the same as CBT-GSH with the exception that all self-monitoring will be conducted through Noom Monitor and individuals will receive a specialized set of instructions on how to use the monitor. Therapists will also be asked to check feedback report on clients before each session. Therapists will receive weekly letter grades regarding each patient based on weekly level of OBEs/Purging, treatment adherence, and weekly weighing.
16067681|NCT02399969|Other|Battlefield Acupuncture|Patients with low back pain will be randomized to receive Battlefield Acupuncture, ASP indwelling needles in 5 auricular (ear) points plus standard of care, or patients will be randomized to receive standard of care alone.
16067682|NCT02399956|Other|Survey|Those who agree to participate will complete a cross-sectional survey on lactation outcomes (LACOUT). Eligible participants who consent to our study will complete the LACOUT questionnaire. The questionnaire uses the same breastfeeding measures as the CDC's Project First surveys and adds 21 items that are specific to the participant's cancer treatment and current health status.
16067683|NCT02399943|Drug|Trametinib|
16067684|NCT02399943|Drug|Panitumumab|
16067685|NCT02399930|Other|Respiratory & Heart Rate Data Collection|"This is a purely observational study - no intervention is being administered. Data is being collected from the medical record and patient monitoring devices.
~Participants will wear the cableless device on their chest. This is a lightweight, small device that sticks onto the skin. We will record breathing rate and respiratory rate from this device. We will also collect this information from the medical record.
~If a participant is placed on telemetry monitoring during the study period, we will collect information about alarm alerting patterns."
16067686|NCT02399917|Drug|Azacitidine|Given SC or IV
16067687|NCT02399917|Biological|Lirilumab|Given IV
16067688|NCT02399904|Other|california tri-pull taping|To approximate the humeral head into the glenoid cavity participants were instructed to place their affected arm on a wooden table. Three piece of tape was used, firstly we applied cotton undercover pre tape and then we applied the rigid post tape on it. First piece (middle) of tape was applied from 1.5 inches below the deltoid tuberosity up to 2 inches above the glenoid cavity. Second piece (posterior) was applied from 1.5 inches below the deltoid tuberosity upto the 1.5 inches above the mid spine of scapula. Third piece (anterior) was applied from the 1.5 inches below the deltoid tuberosity upto the 1.5 inches above the clavicle.
16067689|NCT02399891|Other|Quality Assurance Implementation|
16067690|NCT02399891|Other|Standard of Care|
16067691|NCT02399878|Drug|Inspiratory oxygen|
16067692|NCT02399865|Other|Youth Social Behaviour and Network Therapy|"The Y-SBNT will be delivered according to the developed purpose-designed therapy manual. Participants randomised to Y-SBNT will be offered six, 50 minute SBNT sessions for over a maximum period of 12 weeks. Where consent is obtained, sessions will audio-recorded and reviewed by the research team to ensure fidelity with the YSBNT manual and principles of practice.
~Using the identification of the social network of the young person conducted in the first session as a platform, subsequent core strategies of the adapted YSBNT approach include motivational techniques, improving communication and coping mechanisms, and crucially given the nature of substance misuse, developing a network-based relapse management plan. Participants will be given the opportunity to invite members of their network to the treatment sessions. The therapeutic approach also has scope to address client-focussed elective areas, for example, educational requirements."
16067693|NCT02399852|Drug|Lomitapide|
16067694|NCT02399839|Drug|lomitapide|As prescribed by Physician.
16067695|NCT02399826|Device|Offloading|"Provision of an offloading cam walker or cast boot, may also convert to total contact cast and add felt or foam to supplement"
16067696|NCT02399826|Procedure|Dressing Application|Application of a non adherent dressing, and a multi-layer compression dressing
16067697|NCT02399813|Drug|ADXS11-001|
16067698|NCT02399800|Procedure|Celiac Block with triamcinolone and bupivicaine|Endosonography of the pancreas performed following by analgesic injection
16067973|NCT02397720|Other|Laboratory Biomarker Analysis|Correlative studies
16067699|NCT02399800|Procedure|No Celiac Block|EUS but no celiac block performed
16067700|NCT02399800|Drug|Intra Plexus Triamcinolone and Bupivicaine Injection|Injection of Triamcinolone and Bupivicaine into celiac plexus for pain relief
16067701|NCT02399787|Other|blastocyst biopsy|Performed on day 5
16067702|NCT02399774|Device|Leboride|"Post-partum primi and multiparous women whom are interested in breastfeeding and have not begun yet. This arm will be randomized into 2 groups
~Intervention group: participants will receive the dental device and be instructed to use it during breastfeeding.
~Control group: participants will not receive any device for breastfeeding pain control
~Post-partum women that have already begun breast feeding, will receive the dental device and each woman will be serve as her own control (breastfeeding before and after the use of the dental device."
16067703|NCT02399735|Biological|Low Dose NK cells ×4 times|Received conventional treatment and NK cells once per two-week for the first two-month, at a dose of 5×10E9 NK cells.
16067704|NCT02399735|Biological|Normal Dose NK cells ×4 times|Received conventional treatment and NK cells once per two-week for the first two-month, at a dose of 1×10E10 NK cells.
16067705|NCT02399735|Biological|Normal Dose NK cells ×8 times|Received conventional treatment and NK cells once per two-week for the first four-month, at a dose of 1×10E10 NK cells.
16067706|NCT02399722|Device|WICVAC|combined wound therapy
16067707|NCT02399722|Device|VAC mono therapy|mono therapy
16067708|NCT02399709|Drug|simvastatin|
16067709|NCT02399709|Drug|Placebo|
16067710|NCT02399696|Behavioral|Primary Care-Brief Mindfulness Program|A 4-week group program adapted from the 8-week Mindfulness Based Stress Reduction (MBSR) curriculum
16067711|NCT02399696|Behavioral|Primary Care-Treatment as Usual|Typical VA primary care treatment, including mental health services delivered by primary care staff.
16067712|NCT02399683|Biological|Trichuris trichiura eggs|Live eggs from human whipworm, Trichuris trichiura
16067713|NCT02399657|Drug|Intravitreal dexamethasone 0.7mg implant|Ozurdex at day 0 (fixed), 5 months (fixed), 10 months pro re nata or 11 months pro re nata
16067714|NCT02399644|Behavioral|ACT|ACT is a type of Cognitive behavioral Therapy (CBT) that focuses on acceptance and mindfulness. The aim is to prevent avoidance and control of negative private events such as anxiety or pain. The treatment consists of 7 weekly group sessions, 2 hours a week. The participants are given homework between sessions.
16067715|NCT02399644|Other|Physical activity|Participants are going to perform a training programme including aerobic exercise as well as endurance and strength training for the neck, shoulders, low back, core and leg muscles. The training is group-based and supervised by a physiotherapist two times a week, one hour a time for eight weeks. Home exercises twice a week are also a part of the intervention. It is possible to individually adjust movements and intensity to the participants' capacity if needed.
16067716|NCT02399631|Other|Enhanced recovery program|Enhanced recovery program day-1: no mechanical bowel preparation, intake permit until 6 hrs before operation day0: operation, postoperative fluid therapy, antibiotics day1: liquid diet, early ambulation, removal of foley catheterization day2-3: soft diet day 4-5: discharge
16067717|NCT02399618|Drug|Fecal Microbiota Transplantation|Fecal microbiota transplant from healthy, unrelated donor via freeze-dried capsule
16067718|NCT02399605|Other|Stimulation|Subcutaneous abdominal electrical stimulation
16067719|NCT02399592|Drug|Bevacizumab|10 mg/kg q3w
16067720|NCT02399592|Drug|Tocotrinol|300 mg tid
16067721|NCT02399579|Other|Provocation test|The participants will perform 8 provocation tests. Every provocation test consists of petting the cat until the participants become symptomatic. The symptoms of cat allergic participants with the cat owner's cat will be recorded before and after petting the cat.
16067722|NCT02399566|Drug|Erlotinib, Pemetrexed|followed classical chemotherapy for 4 cycles, use Erlotinib orally for the maintenance therapy.
16067723|NCT02399553|Other|Soccer boot intervention|
16067724|NCT02399540|Device|Sham|Bihemispheric 1mA Sham protocol: sham - pause - sham
16067725|NCT02399540|Device|Conventional Paired tDCS|Bihemispheric 1mA Sham protocol: sham - pause - sham Conventional Paired tDCS protocol: 20 minutes tDCS - pause - sham
16067726|NCT02399540|Device|Conventional Unpaired tDCS|Bihemispheric 1mA Sham protocol: sham - pause - sham Conventional Unpaired tDCS protocol: 20 minutes tDCS - pause - sham
16067727|NCT02399540|Device|Late LTP-like Plasticity tDCS|Bihemispheric 1mA Sham protocol: sham - pause - sham Late LTP-like Plasticity tDCS protocol: 10 minutes tDCS - 25 minutes pause - 10 minutes tDCS
16067728|NCT02399514|Other|Polysomnographic diagnostic|Polysomnographic diagnostic performed one prior to Coil Treatment, one six months after and one twelve month after Coil Treatment
16067729|NCT02399501|Procedure|hysteroscopy|Hysteroscopy is done under general anesthesia. The hysteroscopy used is rigid continuous flow diagnostic hysteroscopy (Tuttligen, Karl Storz, Germany). It has a 30º panoramic optic which is 4 mm in diameter and the diagnostic continuous flow outer sheath is 6.5 mm in diameter.
16067730|NCT02399501|Device|two dimensional ultrasound|Examination is performed after emptying of the bladder in dorsal lithotomy position .The probe is introduced into the posterior fornix of the vagina, then the following structures are examined, the uterus for site, size and mobility, the myometrium for fibroids and adenomyosis, the endometrium for uniformity, polyps, submucous fibroids and intrauterine adhesions, the cervix for nabothian follicles and polyps, the adenexa and ovaries for site, size, mobility, follicles, cysts and corpus luteum
16067731|NCT02399501|Device|saline sonohysterography|sterile speculum is introduced and the vagina and cervix is cleaned with povidone iodine 10%. Cook ET (embryo transfer) catheter is used. . After introduction of the catheter into the cervix, a twenty milliliter syringe which will be prefilled with the distending media (saline) then fitted to the catheter. The speculum is removed and endovaginal probe is introduced in the posterior vaginal fornix
16067732|NCT02399501|Device|three dimensional ultrasound|The uterus is visualized in the longitudinal plane, the ultrasound probe is kept steady and the patient is asked to lie still on the examination bed. The volume mode is switched on. Three D volume is generated by the automatic rotation of the mechanical transducer through 360º. The acquired volume is in the shape of a transacted cone with a depth of 4.3 - 8.6 cm and a vertical angle α = 90º. Using the medium line density, the typical acquisition time is a round 10 seconds
16067733|NCT02399488|Device|Masimo Radical 7|Simultaneous determination of haemoglobin with the continuous haemoglobin monitor, the central lanboratory coulter and a POC:
16067734|NCT02399475|Drug|Levothyroxine|Oral levothyroxine with a total starting dose of 0.7mcg/kg/day split into three daily doses will be titrated to a target TSH level of 0.5 -1.5mU/L
16067735|NCT02399475|Drug|Liothyronine|Oral liothyronine with a starting dose of 1/3 of the weight-based LT4 dose divided into three daily doses titrated to a target TSH level of 0.5 -1.5mU/L
16067736|NCT02399475|Drug|Thyrotropin-Releasing Hormone|200 µg intravenous TRH will be given at study visit 1 (baseline), study visit 2 (on first thyroid treatment), and study visit 3 (on second thyroid treatment).
16067737|NCT02399462|Drug|Acthar|"Agent Dose Route Schedule H.P. Acthar Gel 40 units SC twice weekly* Weeks 1 and 2
~H.P. Acthar Gel 80 units SC twice weekly* Weeks 3 through 24
~H.P. Acthar Gel 80 units SC once weekly* Weeks 25 through 26
~H.P. Acthar Gel 40 units SC once weekly* Weeks 27 through 28
~*Injections are to be spaced 72-96 hours apart (+/-6 hours)."
16067738|NCT02399449|Drug|sodium ferric gluconate (brand)|brand product
16067739|NCT02399449|Drug|sodium ferric gluconate (generic)|generic product
16067740|NCT02399436|Behavioral|School-Based Healthy Snacking Campaign|"The school-based healthy snacking campaign includes the following activities:
~Sales promotion of snack choices that meet federal Smart Snack guidelines during the school day and at school events, such as snack bars and after-school events;
~The installation of new filtered water fountains outfitted with water-filling stations;
~The distribution of re-usable water bottles to students at participating schools; and
~A social marketing campaign to support adoption of the healthy snacks and water consumption by students."
16067741|NCT02399436|Behavioral|Community Cooking Classes|Cooking classes will be delivered to groups of 8-12 adult participants as a series of 8 weekly classes in community venues. The content of each class is driven by topics and themes identified and prioritized by community members, namely cooking healthy on tight budget.
16067742|NCT02399423|Behavioral|Weight gain|Weight gain of 7% body weight over 4-6 weeks by ingesting an extra 1500-2000 kcal/day
16067743|NCT02399423|Behavioral|Weight loss|Weight loss of 7-15% body weight over 12 weeks by increased exercise and either an alternate day fasting dietary regime or a weight watchers dietary regime
16067744|NCT02399410|Drug|perioperative chemotherapy plus bevacizumab|preoperative and postoperative combination chemotherapy with bevacizumab
16067745|NCT02399410|Procedure|cytoreductive surgery|complete or nearly complete removal of synchronous or metachronous peritoneal carcinomatosis from CRC.
16067746|NCT02399410|Drug|Intraperitoneal Oxaliplatin|Pump-driven intraperitoneal administration of oxaliplatin
16067747|NCT02399397|Procedure|Serial blood sampling|Serial blood samples are being collected at times 0, 2, 5, 10, 15, 20, 30, 60, 120, 180, 240 and 360 minutes after rocuronium administration.
16067748|NCT02399397|Procedure|Train of four monitoring|Neuromuscular blockade is being evaluated at the same time of blood sampling by stimulation of the adductor muscle of the thumb on the ulnar nerve through the train of four monitoring (TOF).
16067749|NCT02399397|Procedure|Blood testing for liver and renal function|Blood testing: urea, creatinine, aspartate aminotransferase, alanine aminotransferase, albumin, glycemia
16067750|NCT02399397|Drug|General anesthesia|All patients were induced with individual intravenous doses of midazolam, rocuronium, fentanyl and propofol.
16067751|NCT02399397|Procedure|Small to medium sized surgery under general anesthesia|Patients classified according American Society of Anesthesiologists (ASA) as ASA I-III and submitted to small-medium sized surgery under general anesthesia were recruited for the present investigation.
16067752|NCT02399371|Biological|Pembrolizumab|Given IV
16067753|NCT02399371|Other|Laboratory Biomarker Analysis|Correlative studies
16067754|NCT02399371|Other|Pharmacogenomic Study|Correlative studies
16067755|NCT02399345|Drug|ombitasvir/paritaprevir/ritonavir, dasabuvir|tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
16067756|NCT02399345|Drug|sofosbuvir (SOF)|tablet
16067757|NCT02399345|Drug|ribavirin (RBV)|tablet
16067758|NCT02399332|Other|Community pharmacist involvement|Collaborative involvement of the community pharmacists in formulating and following complex care plans
16067759|NCT02399319|Procedure|Internal Fixator|Internal fixator refers to pins usually inserted into the iliac bones and then connected together by clamps and bars that are inserted under the skin, internally.
16067760|NCT02399319|Procedure|Symphyseal Plate|A plate that spans across the symphysis to maintain reduction and stability.
16067761|NCT02399306|Drug|Enteral nutrition|Patients in the Trial Group received concurrent chemoradiotherapy and standardized, whole-course enteral nutrition management.
16067762|NCT02399306|Radiation|radiotherapy|"Patients receive intensity modulated radiation therapy(IMRT) from week 1 to week 7,once a day, 5 times per week.
~Radiotherapy dose：95% gross tumor volume（GTV-T） 60-66 Gy /30-33f，GTV-N 60-66 Gy /30-33f，CTV-T 50-54 Gy /25-27f，CTV-N 50-54 Gy /25-27f."
16067763|NCT02399293|Behavioral|N-back|"The N-back task required patients to monitor a continuous sequence of stimuli (in this experiment audio and visual stimuli). Press a button if the current stimulus is the same as that shown N back in the sequence. N increases if performance is good and decreases if performance is poor.
~Subjects train for 20 days, 12 blocks a day, 20+N trials per block. That is 240 blocks in total. A minimum of 10 blocks per day counts as a successfully trained day."
16067764|NCT02399293|Behavioral|Visual Search|"The Visual Search task consists of a NxN array of shapes. Press the button if a certain target stimulus is present in this array. N increases if performance is good and decreases if performance is poor.
~Subjects train for 20 days, 12 blocks a day, 20+N trials per block. That is 240 blocks in total. A minimum of 10 blocks per day counts as a successfully trained day."
16067765|NCT02399280|Behavioral|Lunch as main meal(LM)+ Diet|Subjects are asked to have high caloric intake at lunch and low caloric intake at dinner, while they are on a multidisciplinary weight loss plan for 12 weeks.
16067766|NCT02399280|Behavioral|Dinner as main meal(DM)+ Diet|Subjects are asked to have high caloric intake at dinner and low caloric intake at lunch, while they are on a multidisciplinary weight loss plan for 12 weeks.
16067767|NCT02399267|Procedure|Once daily screening|RTs will screen invasively ventilated patients between approximately 06:00 - 08:00 hours daily. To pass the 'readiness to wean screen' and undergo an SBT, specific criteria must be met.
16067768|NCT02399267|Procedure|Twice daily screening|In the 'at least twice daily' screening arm patients will be screened at a minimum between approximately 6:00-8:00 hours and 13:00-15:00 hours daily. To pass the 'readiness to wean screen' and undergo an SBT, specific criteria must be met.
16067769|NCT02399267|Procedure|PS SBTs|Patients are assigned a SBT technique. All SBTs for these patients must be conducted on PS =< 8 cm H2O with PEEP =< 5 cm H2O.
16067770|NCT02399267|Procedure|T-piece SBTs|Patients are assigned a SBT technique. All SBTs for these patients must be conducted with T-piece.
16067771|NCT02399241|Device|Bluetooth enabled nebuliser device (I-neb)|
16067772|NCT02399228|Drug|0.25% EISO mouth rinse|A mouth rinse to be used three times a day during the course of radiation and/or chemotherapy to prevent or minimize oral mucositis
16067773|NCT02399215|Other|Laboratory Biomarker Analysis|Correlative studies
16067774|NCT02399215|Drug|Nintedanib|Given PO
16067775|NCT02399215|Other|Pharmacological Study|Correlative studies
16067776|NCT02399215|Other|Quality-of-Life Assessment|Ancillary studies
16067777|NCT02399202|Drug|osilodrostat|
16067778|NCT02399189|Drug|R-MT followed by auto-HSCT|Four cycles of Induction therapy: Rituximab 375mg/m2 d1; Methotrexate 3.5g/m2 d2;Temozolomide 100mg/m2 d2-6; for patients who reach a CR, PR, or SD, will proceed to autologous stem cell transplantation: Carmustine 400mg/m2 d1; Thiotepa 5mg/kg q12h, d2-3.
16067779|NCT02399176|Behavioral|Yoga|Subjects assume 10 physical postures for 30 seconds each
16067780|NCT02399163|Drug|Fluoride free toothpaste|Brushing with fluoride free toothpaste
16067781|NCT02399163|Drug|Fluoride toothpaste|Brushing with fluoride containing toothpaste
16067782|NCT02399163|Drug|Fluoride mouthwash|"Fluoride mouth wash to be followed after brushing with fluoride free toothpaste in Placebo dentifrice/Fluoride rinse arm and in Fluoride dentifrice/Fluoride rinse arm"
16067783|NCT02399150|Other|No intervention as observational study|
16067784|NCT02399137|Drug|MM-141|
16067785|NCT02399137|Drug|Placebo|
16067786|NCT02399137|Drug|Gemcitabine|
16067787|NCT02399137|Drug|Nab-Paclitaxel|
16067788|NCT02399124|Device|PROSENSE™|single arm, open label, PROSENSE™ treatment
16067789|NCT02399111|Device|Prevena Incision Management System|The PIMS unit is a single patient use, battery-powered, disposable unit that delivers continuous negative 125 mmHg pressure to the closed surgical incision for a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister. For the purposes of this clinical investigation, canisters can be replaced as often as is needed. A carrying case is also provided with the therapy unit, to allow for patient mobility during the therapy period.
16067790|NCT02399098|Behavioral|Attentional focus|The participants will learn the dart throwing task according to specific instructions. Participants in all groups will be given the same technical instructions on how to throw the dart. The technical instructions will be followed by attentional focus instructions that will differ between the groups.
16067791|NCT02399085|Drug|MOR00208|12 mg/kg
16067792|NCT02399085|Drug|Lenalidomide|25 mg
16067793|NCT02399072|Other|No intervention|No intervention administered in this study
16067794|NCT02399059|Procedure|Antibiotic lavage|Peritoneal irrigation with gentamycin-clindamycin solution
16067795|NCT02399059|Procedure|Normal saline lavage|Peritoneal irrigation with normal saline
16067796|NCT02399046|Device|Total Knee System made in China (Sigama, CoCr, PFC)|SIGAMA PS FEMUR; TIB tray Cem Cocr; SIGAMA STAB XLK INS; PFC SIG ROUND DOME PAT 3PEG
16067797|NCT02399046|Device|Total Knee System made outside of China (Sigama, NP, PFC)|SIGAMA PS CEM FEM; PFC MOD TIB TRAY NP; SIGAMA STAB XLK INS; PFC SIGAMA/RD/DOME PAT
16067798|NCT02399033|Drug|Xihuang Capsules|In two weeks after hepatectomy, Xihuang Capsules group received Xihuang Capsules (2 g, bid), Continuously taking to cancer recurrence or death.
16067799|NCT02399020|Behavioral|Social Cognition and Interaction Training|manualized group treatment providing training in facial emotion recognition, understanding the role of emotion in social situations, training with videoed vignettes to avoid jumping to conclusions in order to avoid attributional biases, tolerating ambiguity and distinguishing facts from guesses, skill consolidation and generalization to everyday life situations.
16067800|NCT02399007|Device|Total Hip System made in China (SUN, CoCr, Duraloc, Marathon)|SUN Hip stem,CoCr Femoral Head,Duraloc Porocoat Sector acetabular shell,Marathon 10D polyethylene liner (ETO)
16067801|NCT02399007|Device|Total Hip System made outside of China (Summit, CoCr, Duraloc, Marathon)|Summit Porocoat STD,CoCr Femoral Head,Duraloc Porocoat Sector acetabular shell,Marathon 10D polyethylene liner (ETO)
16067802|NCT02398994|Drug|Intravenous Methylprednisolone|
16067803|NCT02398994|Drug|Intravenous Immunoglobulin|
16067804|NCT02398981|Other|Clinical decision support tool|
16067805|NCT02398968|Dietary Supplement|iron fumerate|iron fumerate supplementation (6mg/kg/d) for arm 1 iron fumerate supplementation (1mg/kg/d) for arm 2
16067806|NCT02398955|Device|percutaneous coronary intervention|percutaneous coronary angioplasty with implantation of at least one Biomime stent
16067807|NCT02398929|Drug|Bisoprolol 2.5 mg|Bisoprolol 2.5 mg will be given once daily
16067808|NCT02398929|Drug|Placebo|Placebo tablets will be given once daily for 2 weeks during the run-in period.
16067809|NCT02398916|Behavioral|Music listening|
16067810|NCT02398903|Other|Blood samples for measurement of drug Css|Blood samples for measurement of drug Css
16067811|NCT02398903|Other|DXA and impedancemetry|Body composition by DXA and impedancemetry
16067812|NCT02398890|Other|routine care|routine care
16067813|NCT02398877|Other|stress|
16067814|NCT02398864|Procedure|EBUS with TBNA|endobronchial ultrasound (EBUS) with transbronchial needle aspiration (TBNA)
16067815|NCT02398851|Behavioral|TacTic care model|Patients receive care in a trans-disciplinary chronic disease continuity of care model integrated with technology (mobile devices such as tablets, iPads and smartphones
16067816|NCT02398851|Behavioral|Standard of care|Patients receive care in a patient-centered, coordinated care model without the integration of technology
16067817|NCT02398838|Drug|Home administration of 200 mg mifepristone|Home administration of 200 mg mifepristone.
16067818|NCT02398838|Drug|Home or clinic administration of 400 mcg buccal misoprostol|Home or clinic administration of 400 mcg buccal misoprostol
16067965|NCT02397785|Device|Sham Device|Identical to ApexM but will not deliver any electrical stimulation
16067819|NCT02398825|Drug|Ponatinib|Ponatinib is given orally 30 mg daily, with dose adjustment to 15 mg daily once a BCR-ABL1 level minor or equal to 0.1% (MMR) has been achieved and confirmed in the next test, 4 weeks apart. A return to prior, 30 mg, dose is due in case of return of BCR-ABL1 transcripts level to > 1%. Dose adjustments for toxicity are detailed in the protocol.
16067820|NCT02398812|Other|Medication assessment and treatment plan based on it|"Intervention
~Phase I: A medication assessment conducted by an interprofessional team including nurse, pharmacist and physician. The assessment is based on current medication list and basic information cathered by nurse.
~Phase II: This phase is needed if the assessment cannot be conducted safely without physical examination conducted by physician. The comprehensive interprofessional assessment takes place after the clinical examination conducted by home care physician."
16067821|NCT02398799|Behavioral|Psychoeducational support|"The intervention was based on a conceptual model from Stuifbergen. The model has sprung from Pender's model of health promotion and Bandura's self-efficacy theory. Cognitive-behavioral strategies were chosen to assist dyads in recognizing and modifying factors that contribute to physical and emotional distress by changing thoughts and behaviors and assisting dyads in solving problems related to implementing strategies for self-care.
~Shared care is a dyadic process based on the assumption that each participant affects and is affected by the other. Shared goals and a shared commitment provide the essential building blocks of the dyad relationship. The dyad structure presents an opportunity for healthcare professionals to integrate a collaborative patient-partner centered effort."
16067822|NCT02398786|Other|Patient-entered data|This registry provides patient-entered data for future clinical trial and study use.
16067827|NCT02398760|Other|Motor Control Exercises|Subjects performed 8 weeks of motor control exercises intervention, 2 weekly 1 hour per session, instructed by trained physiotherapists to apply this program following a protocol developed in programs previously reported (Costa et al. 2009; Hodges et al. 2009). The first stage aims to improve the activity of muscles that have poor control and reduce overactivity of superficial muscles, previously assessed, through drawing in maneuver with feedback real-time ultrasound and via palpation. The second stage of the treatment involved more functional exercises, first using static and then dynamic tasks.
16067828|NCT02398747|Drug|AZD2014|50mg continuous dosing, 125mg intermittent dosing, 25 mg and 50mg intermittent dosing with weekly Paclitaxel
16067829|NCT02398734|Device|sonolysis|Continual transcranial Doppler monitoring of ipsilateral middle cerebral artery using a transcranial Doppler systems (e.g. DWL Multi-Dop T1, DWL, Sipplingen, Germany) with a diagnostic 2-MHz probe.
16067830|NCT02398721|Other|Fine Needle Aspiration Cytology|
16067831|NCT02398708|Other|Questionnaires|Both groups will have questionnaires collected and compared.
16067832|NCT02398708|Other|Blood Sample|Both groups will have a blood sample collected and compared.
16067833|NCT02398708|Other|Stool Sample|Both groups will have a stool sample collected and compared.
16067834|NCT02398708|Other|Clinical data|Both groups will have clinical data collected and compared.
16067835|NCT02398695|Other|Oral Samples|Oral samples of saliva, dental plaque and DNA will be collected between the two groups.
16067836|NCT02398682|Other|Rapid diagnosis of AKI cause|"The Outreach team will advise on an evidence-based package of care:
~1) Rapidly establish a credible diagnosis of the cause of AKI including:
~Improved assessment of volume status
~Standardised use of urine dipstick .
~Appropriate sepsis investigations.
~Urgent ultrasound with suspected obstruction."
16067837|NCT02398682|Other|Rapid treatment of AKI cause|Rapid, limited treatment of hypovolaemia, with avoidance of iatrogenic fluid overload, recently recognised as a significant cause of mortality in AKI. Rapid sepsis therapy. Urgent relief of urinary tract obstruction.
16067838|NCT02398682|Other|Stopping 'nephrotoxic' drugs|Cessation of all potentially nephrotoxic drugs.
16067839|NCT02398682|Other|Early nephrology followup for stage 3 AKI|A rapid followup at discharge in an AKI clinic for survivors of stage 3 AKI, within 7 days of discharge for those in hospital, or within 7 days of the Alert for those not admitted to hospital.
16067840|NCT02398682|Other|Preventing recurrent AKI|Patients with AKI in the Intervention arm will receive information on preventing AKI during the study.
16067841|NCT02398682|Other|Good standard care|Good standard care will be provided for all patients in non Experimental arms; clinicians will continue to be able to rapidly refer patients for Nephrology advice or review; online guidance will be available for all clinicians and noted in the alerts for all cases of AKI.
16067842|NCT02398669|Drug|Lorcaserin hydrochloride|A single 10 mg dose of oral tablet formulation of lorcaserin hydrochloride will be administered with 240 mL of water.
16067843|NCT02398656|Drug|Tenecteplase|TNK will be administered as a single intravenous bolus over 1-2 minutes within 90 minutes of the CT scan.
16067844|NCT02398656|Drug|Antiplatelet treatment|Low dose aspirin (single agent) will be the choice of most physicians, some Investigators will chose to use the combination of aspirin and clopidogrel.
16067845|NCT02398643|Other|Pulmonary Education (PE)|Patients enrolled in PE will undergo focused education sessions following discharge from hospital.
16067846|NCT02398643|Other|Usual Care|Patients enrolled in usual care will receive general education sessions following discharge from hospital.
16067847|NCT02398630|Radiation|TC Virtual Hysterosalpingography|Virtual hysterosalpingography: a new multidetector CT technique for evaluating the female reproductive system
16067848|NCT02398630|Other|MRI Virtual Hysterosalpingography|Magnetic Resonance Imaging Virtual hysterosalpingography
16067849|NCT02398630|Other|Antimullerian Hormone dosing|Blood Draw for Antimullerian Hormone dosing
16067850|NCT02398630|Other|Transvaginal Echography|Transvaginal Echography for evaluating the female reproductive system
16067966|NCT02397772|Drug|albendazole|Single dose of albendazole (400 mg)
16067967|NCT02397759|Other|Blood draw and cerebrospinal fluid draw|
16067968|NCT02397746|Device|total hip arthroplasty implant|
16067969|NCT02397733|Radiation|Prophylactic cranial irradiation (PCI)|Prophylactic cranial irradiation (PCI): 25 Gy in 10 daily fractions, five times a week
16067970|NCT02397733|Radiation|Hippocampal avoidance PCI|Hippocampal avoidance prophylactic cranial irradiation 25 Gy in 10 daily fractions, five times a week
16067852|NCT02398604|Drug|Allo-hMSCs|Allogeneic Human Mesenchymal Stem Cells
16067853|NCT02398604|Drug|Placebo|Placebo
16067854|NCT02398591|Drug|JNJ 53718678|JNJ 53718678 will be orally administered once in a dose of 250, 500 or 1000 mg on Day 1.
16067855|NCT02398591|Drug|Placebo|Placebo matching to JNJ 53718678 will be orally administered once on Day 1.
16067856|NCT02398578|Device|Amphora OAB Device|Cystoscopic procedure to treat OAB
16067857|NCT02398565|Other|No intervention|
16067858|NCT02398552|Drug|Sunitinib|altenative schedules of sunitinib as first line therapy in metastatic renal cell carcinoma patients.
16067859|NCT02398539|Drug|Silver Nitrate|Silver Nitrate Sticks
16067860|NCT02398539|Drug|Triamcinolone|0.5% cream
16067861|NCT02398526|Drug|Radium-223 dichloride, (Xofigo, BAY88-8223)|Dosage and treatment duration according to the decision of the treating physician
16067862|NCT02398513|Drug|Regorafenib (Stivarga, BAY73-4506)|Regorafenib 160 mg per oral
16067863|NCT02398500|Biological|LMG324|IVT injection
16067864|NCT02398500|Biological|Ranibizumab 0.5 mg|IVT injection
16067865|NCT02398500|Biological|Sham|Fake injection used for masking purposes
16067866|NCT02398487|Device|cigalike with nicotine|cigalike 24 mg nicotine or 16 mg nicotine
16067867|NCT02398487|Device|Personal Vaporizer with nicotine|Personal Vaporizer 16 mg nicotine or 9 mg nicotine
16067868|NCT02398474|Drug|TFP block ropivacaine|
16067869|NCT02398474|Drug|ropivacaine infiltration of the iliac crest bone|
16067870|NCT02398461|Drug|rHIgM22|Administered via IV infusion
16067871|NCT02398461|Drug|Placebo|
16067872|NCT02398448|Drug|Zyloprim® 300 mg|
16067873|NCT02398448|Drug|Allopurinol 300 mg; undergranulated, high hardness condition|There will be a period for interim analysis after administration of Regimen B to determine the formulation within the process design space that provides the desired in vitro dissolution variant for dosing in the subsequent study period
16067874|NCT02398448|Drug|Allopurinol 300 mg; alternative condition 2|There will be a period for interim analysis after administration of Regimen C to determine the formulation within the process design space that provides the desired in vitro dissolution variant for dosing in the subsequent study period
16067875|NCT02398448|Drug|Allopurinol 300 mg; alternative condition 3|
16067876|NCT02398435|Biological|Tadekinig alfa (recombinant human IL-18 binding protein)|Patients received the study treatment three times a week subcutaneously.
16067877|NCT02398422|Behavioral|Listening Project Protocol|"The filtered-music intervention will consist of listening to computer-altered acoustic stimulation, designed to modulate the frequency band of vocal music passed to the participant. The frequency characteristics of the acoustic stimulation are selected to emphasize the relative importance of specific frequencies in conveying the information embedded in human speech. Modulation of the acoustic energy within the frequencies of human voice, similar to an exaggerated vocal prosody, are hypothesized to recruit and modulate the neural regulation of the middle ear muscles and to functionally reduce sound hypersensitivities and improve auditory processing.
~The non-filtered music intervention will consist of the same music as the filtered-music intervention."
16067878|NCT02398409|Behavioral|ANSWERS - Acquiring New Skills While Enhancing Remaining Strengths|"Randomized trial to evaluate the efficacy of the telephone intervention Acquiring New Skills While Enhancing Remaining Strengthsin informal caregivers of Veterans with stroke and TBI."
16067879|NCT02398409|Other|Control|8 week telephone usual care with education with nurse case manager
16067881|NCT02398383|Other|Oral Glucose Tolerance Test|Subjects will be instructed to fast after midnight the night prior to the study. Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling. Patients will drink 1.75 gm/kg glucose (Glucola) to a maximum of 75 gm. Venous samples for glucose and c-peptide will be drawn from the IV at 0, 30, 60, 90 and 120 minutes. Subjects will be instructed to eat at least 75 gm carbohydrates daily in the week prior to this test.
16067882|NCT02398383|Other|Mixed Meal Tolerance Test|Subjects will be instructed to fast after midnight the night prior to the study. Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling. Subjects will consume 6 kcal/kg (6 ml/kg) Boost High Protein Nutritional Energy Drink (Mead-Johnson) over five minutes to a maximum of 360 ml. Venous samples for glucose, glucagon, GLP-1, GIP, and c-peptide will be drawn at -10, 0, 15, 30, 60, 90, 120, 150, 180, 210, and 240 minutes.
16067883|NCT02398383|Other|Hypoglycemic Clamp|All subjects with CF and adult (but not pediatric) controls will undergo one-step hypoglycemic clamp. Subjects will be instructed to fast after midnight the night prior to the study. Subjects will be admitted to the research unit on the morning of the test for placement of blood-drawing IV for frequent sampling and a second IV for infusion of insulin and dextrose.
16067884|NCT02398370|Biological|Placental Matrix-Derived Mesenchymal Stem Cells (PMD-MSCs)|
16067885|NCT02398357|Drug|Nadroparin Calcium and Warfarin|Patients will take warfarin started at a dose of 2.5mg/d and with titration of dose to maintain a target INR of 2-3,alone with Nadroparin Calcium 4100IU／d，subcutaneous, when taking endoscopy therapy .
16067886|NCT02398344|Device|tDCS active|Transcranial direct current stimulation (tDCS) the active tDCS and placebo will be applied to the temporal cortex (T3) associated Cardiac Frequency Variability (HRV).
16067887|NCT02398344|Device|tDCS Sham|Active stimulation application time or placebo 20 minutes. In all sham stimulation, electrode placement procedures will also be performed like the procedures with anodic tDCS, the left and right temporal cortex, however, the stimulator is turned on for 30 seconds only, and the patient will be told that he will feel a slight initial tingling, but it will reduce, disappear or remain during the 20 minutes of application. Thus, individuals will feel it initially, but receive no stimulation in the remaining time. This procedure is a valid form of control in challenge studies transcranial direct current ³³. The equipment itself has a sham configuration.
16067888|NCT02398331|Other|Standardised information and education on sexuality in women with spinal cord injury|"Program of information and education on the physiology of sexual response in women with spinal cord injury 6 months after their first return to home:
~Educational footage
~Clinical neurological examination with educational aim
~Structured consultation providing information on the physiology of sexual response in women with spinal cord injury"
16067889|NCT02398318|Device|Bilateral Nucleus Accumbens DBS (Suzhou Sceneray)|High frequency stimulation applied using Suzhou Sceneray® DBS hardware (1120 electrode, 1180 (S) battery).
16067890|NCT02398318|Device|Sham Bilateral Nucleus Accumbens DBS|DBS system switched off.
16067891|NCT02398305|Device|TR Band standard|Diminishing the air pressure in the TR Band following standard protocol
16067892|NCT02398305|Device|TR Band Quick|Diminishing the air pressure in the TR Band following a faster protocol
16067893|NCT02398292|Other|M3 Program|Participants and their study partners will learn about food, movement, and mindfulness through hands-on curriculum.
16067894|NCT02398292|Other|Control|Participants will not participate in M3 program but will have same outcomes measured at same time points (baseline, 6 weeks, 12 weeks).
16067895|NCT02398279|Dietary Supplement|L-Arginine|Experimental supplement
16067896|NCT02398279|Other|Placebo|Placebo capsules in the same color and shape with the experimental supplement
16067897|NCT02398266|Drug|Contrast ultrasound of leg muscle with Sonazoid (Contrast ultrasound microvascular perfusion imaging)|Skeletal muscle perfusion assessment of the thigh and calf skeletal muscle will be performed with contrast ultrasound of leg muscle with Sonazoid while at rest and during exercise stress
16067898|NCT02398253|Behavioral|CBT + Hypo-energetic Diet|This group will have cognitive behavioral therapy classes + follow the hypo-energetic diet after losing at least 10% of their body weight by using a weight loss program. They will also have monthly follow-up to 6 months by fortnightly dietician visit.
16067899|NCT02398253|Behavioral|Hypo-energetic Diet only|This group will receive the hypo-energetic diet only after losing at least 10% of their body weight by using a weight loss program. They will also have monthly follow-up to 6 months by fortnightly dietician visit.
16067900|NCT02398240|Drug|Brentuximab Vedotin|Day 1 and 15 Dose: 1.2 mg/kg/dose. (Maximum dose is 120 mg)
16067901|NCT02398240|Drug|Doxorubicin|Days: 1 and 15 Dose: 25 mg/m2/dose.
16067902|NCT02398240|Drug|Vincristine|Days: 1 and 15 Dose: 1.5 mg/m2/dose (max: 2 mg/dose).
16067903|NCT02398240|Drug|Rituximab|Days: 2 and 16 Dose: 375 mg/m2/dose.
16067904|NCT02398227|Behavioral|HOPE|Cognitive Behavioral Treatment for PTSD in Battered Women
16067905|NCT02398227|Behavioral|PCT|Present Centered Therapy for PTSD
16067906|NCT02398214|Behavioral|Sleep hygiene|LAST intervention (light, activity, and sleep training) consists of behavioral and educational strategies for increasing light exposure and physical activity, minimizing television viewing and reducing television viewing time to < 2 hours per day, and engaging activities suitable to the child's motor development to minimize sleep disturbance.
16067907|NCT02398201|Drug|Bezafibrate|Bezafibrate 200mg-600mg three times daily for 12 weeks.
16067908|NCT02398188|Drug|LIPO-202|
16067909|NCT02398188|Drug|Placebo|
16067910|NCT02398175|Other|reanimation/intubation|
16067911|NCT02398162|Procedure|Multi Blood Collections|At baseline (the day of presentation to hospital), 2 weeks, 12 weeks and 1 year later.
16067912|NCT02398162|Procedure|Single Blood Collection|On the enrollment day
16067913|NCT02398136|Drug|Ketamine|
16067914|NCT02398136|Drug|Midazolam|
16067915|NCT02398123|Other|Transversus abdominis plane block|Children who received transversus aAbdominis plane block with 0.25% bupivacaine with epinephrine 1 mL/kg guided by ultrasound
16067916|NCT02398123|Other|Caudal block|Children who received caudal 0.25% bupivacaine 1 mL/kg
16067917|NCT02398123|Drug|Bupivacaine|
16067918|NCT02398110|Procedure|transvaginal NOTES nephrectomy|A 5- and 10-mm trocar were placed at the right and left medial margin of umbilicus. A lengthened 10-mm trocar was placed through the vagina into the abdominal cavity
16067919|NCT02398110|Procedure|conventional laparoscopic nephrectomy|One 10-mm trocar was inserted at the midclavicular line 2 cm below the umbilicus, another 10-mm periumbilical trocar was placed for the camera, and a 5- or 10-mm trocar was placed 3 cm below the costal margin
16067920|NCT02398097|Biological|Agripal|2011/2012 influenza season standard dose trivalent subunit inactivated intramuscular vaccine, single dose
16067921|NCT02398097|Biological|IDflu9μg|2011/2012 influenza season reduced-content intradermal split vaccine, single dose
16067922|NCT02398097|Biological|IDflu15μg|2011/2012 influenza season standard-content intradermal split vaccine, single dose
16067923|NCT02398084|Other|Chewing of nuts|The volunteers will be asked to chew and spit 8 portions (4-5 g) of nuts (cashews or walnuts) on two separate visits. They will provide samples for particle sizing. Two portions will be used as practice samples in order to measure the number of chews. Two portions will be sieved. Two portions will be measured by laser diffraction. Two portions will be frozen for later lipid analysis.
16067924|NCT02398071|Device|A water pressure threshold device (BreatheMAX)|BreatheMAX®, the water pressure threshold breathing device contributed in our laboratory will be used. This device is small, simple, easy to use and also inexpensive since the device is developed and manufactured in Thailand. The depth of water in the body of the device provides the flow resistance during exhalation through the inlet tube in a water cylinder.
16067925|NCT02398058|Drug|trabectedin|trabectedin will be administered in a 24-h continuous i.v. infusion every 3 weeks
16067926|NCT02398058|Drug|olaparib|olaparib will be administered in a continuous daily dose every 12 hours
16067927|NCT02398045|Other|Computerised CBT for OCD|Computerised CBT for OCD
16067928|NCT02398032|Device|CPAP nasal|During the night
16067929|NCT02398032|Device|sham CPAP nasal|During the night
16067930|NCT02398019|Device|OXIRIS®|"OXIRIS® membrane set is composed of a 1.5 m2 copolymer of acrylonitrile and sodium methylsulfonate (AN 69) with polyethylenimine treated surface and adhered heparin during set´s fabrication [OXIRIS® (Baxter Gambro)].
~PrismafleX eXeed™ II (Hospal) with OXIRIS® set will then be connected to CPB circuit. Blood flow between 150-200 ml/min will be derivatised from the CPB circuit into the PrismafleX eXeed™ so that it all flows through OXIRIS® membrane. Flow, pressure and alarms will be controlled by PrismafleX eXeed™ independently from CPB circuit.
~OXIRIS® membrane will be only employed for adsorption (neither convection nor diffusion will be performed) during all CPB time."
16067931|NCT02398006|Other|a standard arm sling|Closed reduction (re-aligning the fragments of the fracture) will be not performed because the reduced position is practically impossible to maintain.
16067932|NCT02398006|Other|a figure-of-eight bandage|Closed reduction (re-aligning the fragments of the fracture) will be not performed because the reduced position is practically impossible to maintain.
16067933|NCT02397993|Procedure|blood collection|blood will be taken for assessment of serum lipase, serum amylase and CA 19-9 prior to EUS-FNA
16067934|NCT02397993|Procedure|fine needle aspiration|During endoscopic ultrasonography, fine needle aspiration will be performed for cytological analysis of the pancreas
16067935|NCT02397993|Procedure|blood collection|blood will be taken 4h after EUS-FNA for assessment of serum lipase, serum amylase and CA 19-9
16067936|NCT02397980|Behavioral|Behavioral intervention|"What the dementia is
~How to deal with behavioral problems in patients with dementia
~How to manage caregiver's stress
~How to care dementic patients as well as caregivers themselves"
16067937|NCT02397967|Other|Neuropsychological assessments|"Neuropsychological assessments:
~Intelligence Quotient (WISC-IV)
~Reading tests (reading accuracy, reading speed, reading comprehension and strategy):
~Alouette test, Lobrot test, Odedys test. Visio-spatial skill (JLO, Thurston, Corsi tests) Attention (CPT 2, CBCL) Receptive oral language (EVIP)"
16067938|NCT02397954|Drug|Zimura|Subjects will receive monthly intravitreous injections of Zimura in combination with Lucentis, Avastin or Eylea.
16067939|NCT02397941|Other|Ultrasound|ultrasound measures
16067940|NCT02397928|Device|NovoTTF-100L device|Patients will be treated continuously with the NovoTTF-100L device. NovoTTF-100L treatment will consist of wearing four electrically insulated electrode arrays on the thorax. The treatment enables the patient to maintain regular daily routine.
16067941|NCT02397928|Drug|Pemetrexed|Pemetrexed 500 mg/m2 will be administered by intravenous infusion over 10 minutes or according to institutional administration timing on day 1 of a 21-day cycle.
16067942|NCT02397928|Drug|Cisplatin or Carboplatin|Cisplatin 75 mg/m2 or carboplatin AUC 5 will be administered by infusion after adequate hydration according to institutional practices beginning approximately 30 minutes after the end on the pemetrexed infusion on day 1 of a 21-day cycle.
16067943|NCT02397915|Drug|FF nasal spray|FF as a suspension for intranasal inhalation with unit dose strength of 27.5 mcg per dose x 4 doses (total dose 110 mcg) administered via a metered side-actuated nasal spray device.
16067944|NCT02397915|Drug|MF nasal spray|MF as a suspension for intranasal inhalation with unit dose strength of 50 mcg per dose x 4 doses (total dose 200 mcg) administered via a metered top-actuated nasal spray device.
16067945|NCT02397902|Dietary Supplement|High fat dairy|Add 4 daily servings per day of high fat dairy (yogurt, milk, cheese) for a period of 4 weeks
16067946|NCT02397902|Dietary Supplement|Plant-based|Add 4 daily servings of fruit (fruit cup, apple sauce) and/or plant-based milk, remove all dairy for a period for 4 weeks
16067947|NCT02397889|Drug|Ketamine|This arm will receive 0.5mg/kg repeated dose ketamine (6 intravenous infusions, 3 per week for 2 weeks).
16067948|NCT02397889|Drug|Midazolam|This arm will receive 0.045mg/kg repeated dose intravenous midazolam (6 intravenous infusions, 3 per week for 2 weeks).
16067949|NCT02397876|Other|Partially Hydrolyzed Whey formula|Patients who tolerate partially hydrolyzed whey formula will be continued on this formula for two years. Patients who do not tolerate the formula will be continued on their prior diet of cows milk avoidance.
16067950|NCT02397863|Drug|Cannabidiol (Epidiolex)|Daily dosage up to 25 mg/kg/day with an optional up titration to a maximal daily dosage up to 50 m/kg/day until End of Treatment.
16067951|NCT02397850|Behavioral|phone calls 30 min|Patients receive either seven 30 minutes phone calls over 6 months (psychotherapy/continuation treatment)
16067952|NCT02397850|Behavioral|phone calls 50 min|Patients receive either seven 50 minutes phone calls over 6 months (psychotherapy/continuation treatment)
16067953|NCT02397837|Drug|Pramipexole|Up to 4.5mg, PO, (by mouth) per day of the 12-week study.
16067954|NCT02397837|Drug|Placebo|placebo match study drug
16067955|NCT02397824|Other|Salivary and blood samples|
16067956|NCT02397811|Dietary Supplement|Enteric Coated Softgels|Enteric coated softgel capsule containing 4 mg astaxanthin, 3 softgels per dose
16067957|NCT02397811|Dietary Supplement|Liposomal astaxanthin|Liposomal astaxanthin containing 4.5 mg astaxanthin per gram. 3.66 grams per dose
16067958|NCT02397811|Dietary Supplement|Standard Softgel|Standard softgel containing 4 mg astaxanthin per softgel. 3 softgels per dose
16067959|NCT02397811|Dietary Supplement|Astaxanthin Water Soluble Emulsion|Astaxanthin water soluble emulsion containing 1% astaxanthin. 1.2 grams per dose
16067960|NCT02397811|Dietary Supplement|Astaxanthin Water Dispersible Powder|Astaxanthin water dispersible powder containing 3% astaxanthin. 0.4 grams per dose
16067961|NCT02397811|Dietary Supplement|Standard Softgel with Astaxanthin Gel|Standard softgel with astaxanthin gel containing 4 mg astaxanthin. 3 soft gels per dose
16067962|NCT02397798|Behavioral|Person-centered high-intense training under supervision|A person-centered training program including a person-centered high-intense aerobic / strength training
16067963|NCT02397798|Behavioral|Personalized exercise program to perform at home|Introduction to health-enhancing physical activity, personalized exercise program to perform at home three times a week
16067964|NCT02397785|Device|ApexM|Subjects will apply conductive gel, insert the device to a minimum depth of 4 inches, and inflate until comfortably snug. The intensity is set exclusively by the physician to a tolerated sensory level, avoiding muscle contraction. At the target amplitude, patients will feel a non-painful fluttering or tapping sensation, Subjects will perform this for 6 sessions per week at 12 minutes per session for an additional 12 weeks. At each follow-up visit, investigators will re-evaluate the stimulation level and adjust to avoid muscle contraction.
16067971|NCT02397720|Drug|Azacitidine|Given SC or IV
16067974|NCT02397720|Biological|Nivolumab|Given IV
16067975|NCT02397707|Drug|Voxilaprevir|100 mg tablet administered orally
16067976|NCT02397694|Drug|BIC|75 mg tablet administered orally once daily
16067977|NCT02397694|Drug|F/TAF|200/25 mg FDC tablet administered orally once daily
16067978|NCT02397694|Drug|DTG|50 mg tablet administered orally once daily
16067979|NCT02397694|Drug|BIC Placebo|Tablet administered orally once daily
16067980|NCT02397694|Drug|DTG Placebo|Tablet administered orally once daily
16067981|NCT02397694|Drug|B/F/TAF|50/200/25 mg FDC tablet administered orally once daily
16067982|NCT02397681|Other|Autonomic Function Testing|Autonomic nervous system index assessed with Task Force Monitor (CNSystems Medizintechnik AG, Graz, Austria)
16067983|NCT02397668|Device|CorMatrix Cor TRICUSPID ECM Valve|CorMatrix Cor TRICUSPID ECM Valve to replace a diseased tricuspid valve, including tricuspid valve disease secondary to congenital heart disease.
16067984|NCT02397642|Procedure|IVF/ICSI|
16067985|NCT02397642|Drug|Human Chorionic Gonadotropin|given in different doses and timing to support the luteal phase
16067986|NCT02397629|Other|This study has no intervention|
16067987|NCT02397616|Other|high resolution esophageal manometry|high resolution esophageal manometry using liquid and solid swallows and a test meal.
16067988|NCT02397603|Drug|dexmedetomidine bupivacaine|perineural dexmedetomidine as an adjuvant to bupivacaine induced thoracic paravertebral block
16067989|NCT02397603|Drug|Bupivacaine saline|perineural bupivacaine saline mixture in the thoracic paravertebral catheter
16067990|NCT02397590|Drug|Fimasartan|
16067991|NCT02397590|Drug|Atorvastatin|
16067992|NCT02397577|Other|Solid test meal, liquid test meal on two separate occations|13C labeld solid test meal, 13C labeld liquid test meal on two separate occations
16067993|NCT02397564|Device|Er:YAG laser, traditional and fractional settings|Half the scar will be treated with traditional ablative setting and the other half will be treated with the fractional ablative setting
16067994|NCT02397551|Procedure|IVF/ICSI|
16067995|NCT02397551|Drug|Human Chorionic Gonadotropin|Given in different doses and timing to support the luteal phase
16067996|NCT02397538|Drug|Fimasartan|
16067997|NCT02397538|Drug|Amlodipine|
16067998|NCT02397538|Drug|Rosuvastatin|
16067999|NCT02397525|Drug|LIPO-202|
16068000|NCT02397512|Drug|application of lactulose|Subjects will ingest 50g of lactulose once
16068001|NCT02397512|Other|application of sucrose|Subjects will ingest 50g of sucrose once
16068002|NCT02397499|Drug|LIPO-202|
16068003|NCT02397499|Drug|Placebo|
16068004|NCT02397486|Drug|Pentoxifylline|
16068005|NCT02397486|Drug|Vitamin E|
16068006|NCT02397486|Drug|Cisplatin|
16068007|NCT02397486|Radiation|Radiation therapy|
16068008|NCT02397473|Drug|Galcanezumab|Administered SC
16068009|NCT02397473|Drug|Placebo|Administered SC
16068010|NCT02397460|Drug|Gefapixant|Gefapixant tablets administered orally as a single dose of 50 mg (1 tablet) or 300 mg (6 tablets)
16068011|NCT02397460|Drug|Placebo|
16068012|NCT02397447|Drug|Momordica charantia|Momordica Charantia: 2000 mg per day for three months
16068013|NCT02397447|Drug|Placebo|Placebo: 2000 mg per day for three months
16068014|NCT02397434|Radiation|Adjuvant EBRT|Radiation up to a median dose of 50 Gy in 25 fractions will be delivered with IMAT to the pelvic lymph node regions. If there is a positive surgical margin, the operative bladder bed will be included in the radiation field. A simultaneous integrated boost to positive lymph nodes will be delivered.
16068015|NCT02397421|Drug|Dapagliflozin|Sodium Glucose Linked Transporter Type 2 (SGLT-2) Inhibitor
16068016|NCT02397421|Drug|Placebo|Capsules containing microcrystalline cellulose Ph Eur overencapsulated in a hard gelatine capsule shell to match the active comparator
16068017|NCT02397408|Drug|Carbon C 11 Choline|Given intravenously (IV) prior to imaging
16068018|NCT02397408|Drug|Fluorine F 18 Choline|Given intravenously (IV) prior to imaging
16068019|NCT02397408|Procedure|Positron Emission Tomography (PET) / Magnetic Resonance Imaging (MRI)|Undergo whole-body PET/MR imaging
16068020|NCT02397395|Drug|Simeprevir (SMV) 150 mg|Simeprevir (SMV) 150 milligram (mg) capsule orally, once daily for a duration of 12 weeks.
16068021|NCT02397395|Drug|Daclatasvir (DCV) 60 mg|Daclatasvir (DCV) 60 mg tablet, orally, once daily for a duration of 12 weeks.
16068022|NCT02397382|Drug|Guselkumab|Guselkumab will be administered as a single dose of 200 milligram (mg) by subcutaneous injection (2*100 mg) on Day 8.
16068023|NCT02397382|Drug|Midazolam|Midazolam will be administered orally as probe cocktail containing 0.03 mg per kilogram (kg) once on Day 1, 15 and 36.
16068024|NCT02397382|Drug|Warfarin|Warfarin will be administered orally as probe cocktail containing 10 mg once on Day 1, 15 and 36.
16068025|NCT02397382|Drug|Omeprazole|Omeprazole will be administered orally as probe cocktail containing 20 mg once on Day 1, 15 and 36.
16068026|NCT02397382|Drug|Dextromethorphan|Dextromethorphan will be administered orally as probe cocktail containing 30 mg once on Day 1, 15 and 36.
16068027|NCT02397382|Drug|Caffeine|Caffeine will be administered orally as probe cocktail containing 100 mg once on Day 1, 15 and 36.
16068028|NCT02397369|Other|Tobacco users: Self Help|This group will be given pictorial material and minimal written materials/ pamphlets describing health hazards of smokeless forms of tobacco and tips on tobacco cessation in general. The material will be interactively tailored to individual tobacco consumption characteristics and they will be followed up after 12 months.
16068029|NCT02397369|Behavioral|Tobacco users:Telephonic counseling|This group will be given proactive as well as reactive counseling. Medical social workers will proactively call all participants regularly and offer tobacco cessation counseling. In addition, they will call those participants who have planned their quit dates. Dedicated independent mobile numbers with 12 hours help lines will be made available to the participants to maximise the level of support. It will be scheduled in response to the needs to answer any type of help pertaining to quitting tobacco.
16068071|NCT02397096|Drug|Doravirine, Tenofovir, Lamivudine|Single tablet containing MK-1439 (doravirine) 100 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg
16068212|NCT02396043|Drug|Intrathecal (IT)|methotrexate (15 mg/m 2 ), cytarabine (40 mg/m 2 ) and dexamethasone (4 mg).induction :d1, 15, 29, 45 ;Protocol M:d1, 15, 29, 43;Reinduction:d31,38
16068030|NCT02397369|Behavioral|Tobacco users:Behavioural therapy Only|"Focus Group discussion:
~This tobacco cessation intervention session will involve thirty minutes of focus group discussion with group behavioral therapy in groups of 5-10 individuals for reinforcement of tobacco use prevention and cessation advice. Group discussion is intended to improve understanding by exploring, sharing and reflecting psychosocial, familial, environmental issues which attribute to the problem.
~Individual tobacco cessation counseling sessions:
~Individual counseling is commonly used to help people who are trying to quit tobacco. The counseling adopting an interactive problem-solving approach will be done by trained Medical Social Workers providing face-to-face sessions for 10-15 minutes per participant."
16068031|NCT02397369|Other|Tobacco users:Pharmacologic|"Pharmaco Therapy will consist of:
~Nicotine Chewing Gums:
~Dose: 2 mg/4 mg, 10-15 pieces per day with maximum dose of 24 pieces/day depending on cravings Total Duration: 12 weeks Duration of treatment: Higher dose for 4-6 weeks, with weaning till 2-3 months Side effects: Bad taste, Throat irritation, burning in mouth, nausea, vomiting, hiccups, increased heart beat etc
~Nicotine Transdermal patches:
~Dose: 7 mg/10 mg/14 mg/21 mg -for 24-hours use. Total Duration: 12 weeks Duration of treatment: Higher strength patch for 2 weeks and depending on cravings will be gradually decreased till 4 weeks Side effects: Skin irritation, dizziness, sleep problems, increased heart beat etc"
16068032|NCT02397356|Drug|Ketamine first AB|Nebulised ketamine 1mg/kg
16068033|NCT02397356|Drug|Placebo first BA|Nebulised saline 1-2ml
16068034|NCT02397343|Drug|Hyperbaric oxygen|
16068035|NCT02397330|Drug|bupivacaine|
16068036|NCT02397330|Device|ultrasound|ultrasound guided nerve blocks
16068037|NCT02397330|Drug|morphine|
16068038|NCT02397317|Radiation|Multi-fraction SABR|All participants will receive Multi-Fraction SABR; 36.25 Gy (PTV D95) in 5 Fractions within 2-5 weeks
16068039|NCT02397304|Other|Exercise|Participants will complete two morning exercise sessions. One will be performed in the overnight fasted-state (i.e. no food or drink, except water, from 10pm the evening before) and the other will be performed in the fed-state having received a breakfast by the research team before exercise.
16068040|NCT02397291|Drug|Mannose|A primed constant infusion containing the stable isotopes of mannose and myoinositol is administered through a peripheral IV.
16068041|NCT02397291|Drug|Myoinositol|A primed constant infusion containing the stable isotopes of mannose and myoinositol is administered through a peripheral IV.
16068042|NCT02397291|Drug|Placebo|placebo
16068043|NCT02397278|Drug|Platelet rich plasma (PRP)|Patient will receive 3 intra articular injections with autologous PRP in the affected knee and then follow conventional therapy.
16068044|NCT02397265|Device|Bi-hormonal closed loop pump|Using a bio-inspired artificial pancreas consisting of a bi-hormonal closed loop pump
16068045|NCT02397265|Device|Standard opened loop pump|Using a standard opened loop pump
16068046|NCT02397265|Device|Insulin closed loop|Using a closed loop
16068047|NCT02397252|Device|Eve Medical self-collection system©|The Eve collection system is a plastic device not much bigger than a tampon that is inserted in the vaginal cavity. A silicone brush is then swiped around the vagina to scrape a few vaginal cells for cervical cancer screening.
16068048|NCT02397252|Device|cobas® PCR Female swab self-sampling|Regular polyester swab for collection of vaginal cells.
16068049|NCT02397252|Procedure|Physician-collected sampling|Routine colposcopy sample collected by a physician.
16068050|NCT02397226|Procedure|Radiofrequency ablation|
16068051|NCT02397226|Procedure|High ligation/stripping|
16068052|NCT02397226|Device|Radiofrequency ablation catheter|
16068053|NCT02397226|Procedure|Tumescent anesthesia|
16068054|NCT02397226|Procedure|General anesthesia|
16068055|NCT02397226|Device|Vein stripping catheter|
16068056|NCT02397213|Drug|Ciclosporin|Single dose of CicloMulsion® 5 mg/ml, 2.5 mg/kg (=0.5 ml/kg) as intravenous injection preoperatively after anesthesia induction.
16068057|NCT02397213|Drug|Placebo|All components of the CicloMulsion® emulsion except ciclosporin: soybean oil (refined), triglycerides (medium-chain), egg lecithin, glycerol, oleic acid, sodium hydroxide and water for injection (=0.5 ml/kg).
16068058|NCT02397200|Dietary Supplement|Nutritional supplementation standardized formula|Powder added to water, containing about 25% of recommended Daily Recommended Intake (DRI) for Calories, high protein (25% of calories) and multi vitamin and mineral (25%-100% of DRI for recommended daily allowance (RDA) or adequate intake )
16068059|NCT02397200|Dietary Supplement|Placebo|Low caloric formula (Powder added to water), without added vitamins and minerals
16068060|NCT02397187|Behavioral|LOOP|"The LOOP conceptualizes the psyche by a three-dimension structure: the space (the potential of experiencing, the place where our experiences occur), the content (the experiences themselves; action, thoughts, feelings, experiences and being) and the order (the relationship between the various contents). The LOOP intervene with these three dimensions by a structures scheme, aimed at allowing the patient to quickly reclaim the responsibility on his psyche, stabilize and initiate long-term rehabilitation processes."
16068061|NCT02397174|Other|mediterranean diet, restricted calorie|50 pcos women will be assigned to hypocaloric mediterranean diet for 6 months
16068062|NCT02397174|Other|hypocaloric diet, restricted calorie|50 pcos women will be assigned to standardized hypocaloric diet for 6 months
16068063|NCT02397161|Other|EEG biofeedback mental attention-neuromuscular training|Mental attention training using EEG biofeedback and neuromuscular training using physio-therapeutic exercises
16068064|NCT02397161|Other|Neuromuscular training|Neuromuscular training using physio-therapeutic exercises
16068065|NCT02397161|Other|EEG biofeedback mental attention training|Mental attention training using EEG biofeedback
16068066|NCT02397148|Radiation|Computed Tomography|imagery with ionizing radiation
16068067|NCT02397148|Radiation|Cone Beam Computed Tomography|imagery with ionizing radiation
16068068|NCT02397122|Biological|platelet-rich fibrin|autologous platelet-rich fibrin was isolated from venous blood of each patient by defined centrifugation methods
16068069|NCT02397122|Procedure|connective tissue graft|connective tissue graft was harvested from the palatal region of each patient by single incision method
16068070|NCT02397122|Procedure|coronally advanced flap|buccal gingival flap was raised by sharp-blunt-sharp dissection and positioned coronally to cover connective tissue graft (and platelet-rich fibrin gel)
16068492|NCT02393859|Drug|Vincrisitne|1.5 mg/m^2/day IV on Days 1 and 6
16068072|NCT02397096|Drug|Baseline regimen of ritonavir- or cobicistat-boosted protease inhibitor|Baseline regimen of antiretroviral therapy with a ritonavir- or cobicistat-boosted protease inhibitor (atazanavir, darunavir, or lopinavir) administered according to the product circular
16068073|NCT02397096|Drug|Baseline regimen of cobicistat-boosted elvitegravir|Baseline regimen of antiretroviral therapy with cobicistat-boosted elvitegravir administered according to the product circular
16068074|NCT02397096|Drug|Baseline regimen of a non-nucleoside reverse transcriptase inhibitor|Baseline regimen of antiretroviral therapy with a NNRTI (efavirenz, nevirapine, or rilpivirine) administered according to the product circular
16068075|NCT02397096|Drug|Baseline regimen of two nucleoside reverse transcriptase inhibitors|Baseline regimen of antiretroviral therapy with two NRTIs administered according to the product circular
16068076|NCT02397083|Drug|Everolimus|Given PO
16068077|NCT02397083|Other|Laboratory Biomarker Analysis|Correlative studies
16068078|NCT02397083|Device|Levonorgestrel-Releasing Intrauterine System|Placed in the uterus
16068079|NCT02397070|Procedure|Jaw exercise program|The jaw exercise program will consist of three cycles: 1st CYCLE - simple opening and closing mouth, right and left lateral excursions with mechanisms of proprioceptive neuromuscular facilitation and muscle coordination; 2 ° CYCLE - opening and closing exercises, right and left lateral excursions with a counter-resistance force imposed by the participant, with reciprocal inhibition, stretching, and muscular endurance mechanisms; 3rd CYCLE - specific exercises to disk capture attempt in cases of disk displacement with reduction and acute disk displacement without reduction (mouth opening and closing in protrusion) or chronic disk displacement without reduction (forced mouth opening in order to push the disc), with remodeling articulate mechanisms. The conduct will be individualized according to the need and symptoms of patients, which will be monitored fortnightly. It will be proposed 3 times a day, lasting a minute and a half per turn, in front of the mirror, during three months.
16068080|NCT02397070|Device|Occlusal Splint and counseling|The occlusal splints will be made from obtaining a plaster type IV model of upper arch using alginate and metal stock tray. A 2mm thick polyacetate blade will be adapted to the vacuum device plasticizer, heated and pressed over the previously cut U-shaped plaster model. After cooling, it will be added the self-curing acrylic resin on occlusal surface in order to increase the vertical dimension of occlusion in 2mm (anterior region). After polishing, the splints will be intraorally adjusted using carbon paper and clamp Muller, and installed obtaining maximum tooth contacts in centric relation. The splints will be flat and of full coverage for night use. Patients will be monitored every two weeks for the occlusal adjustment for three months. It will also be done counseling measures through a printed guide in relation to the daily care and the various contributing factors of TMD (diet, stress reduction, elimination of parafunctions and posture correction).
16068081|NCT02397057|Drug|Injectafer|
16068082|NCT02397057|Other|Placebo|
16068083|NCT02397044|Procedure|Implant surgery|Compare surgical protocols
16068084|NCT02397031|Behavioral|Mindfulness|weekly psychotherapy sessions for 10 weeks (120 min each)
16068085|NCT02397031|Behavioral|interpersonal effectiveness|weekly psychotherapy sessions for 10 weeks (120 min each)
16068086|NCT02397018|Biological|allogeneic umbilical cord blood|Umbilical cord blood units will be selected from a public cord blood bank based on ABO/Rh blood type and cell dose, targeting a range of 0.5 to 5 x 10^7 total nucleated cells per kilogram. The cord blood unit will be intravenously infused into the subject over 5-30 minutes at a rate not exceeding 5 mL/kg/hr. Subjects will not receive immunosuppressive medications or any other cytoreduction prior to infusion.
16068087|NCT02397005|Drug|ZL-2102|A selective and reversible inhibitor of Hematopoietic Prostaglandin D Synthase (HPGDS).
16068088|NCT02397005|Drug|Placebo matching ZL-2102|
16068089|NCT02396992|Other|Minimal-Massive Intervention|The intervention will consist in basic recommendations based on the evaluations done at admission and discharge: a) diet adaptation (solids and fluids) based on dysphagia clinical evaluation (V-VST) to avoid efficacy or safety alterations; b) nutritional supplements in case of malnutrition (MNA-sf; bioimpedance and blood analysis) to improve nutritional status;and c) oral health and hygiene recommendations (toothbrushing and antiseptic mouthwashes to decline bacterial colonization).
16068090|NCT02396979|Drug|Methadone|
16068091|NCT02396979|Behavioral|Holistic Health Recovery Program|
16068092|NCT02396953|Drug|Lanreotide PRF|
16068093|NCT02396940|Device|3D HD laparoscopy|Olympus 3D laparoscopy ENDOEYE FLEX in high definition with the use of passive, polarizing glasses.
16068094|NCT02396940|Device|2D HD laparoscopy|Placebo
16068095|NCT02396927|Device|3D HD laparoscopy|Olympus 3D laparoscopy ENDOEYE FLEX in high definition with the use of passive, polarizing glasses.
16068096|NCT02396927|Device|2D HD laparoscopy|Placebo
16068097|NCT02396901|Other|Goal Direct Therapy|Goal Direct Therapy - in this group patients will receive the standard treatment according with institutional protocol.
16068098|NCT02396888|Drug|Insulin|Half of the wound surface was treated daily with 10 units of intermediate insulin.
16068099|NCT02396888|Drug|Placebo|Half of the wound surface was treated daily with 0.1 cc of normal saline.
16068100|NCT02396875|Procedure|Blood sampling and exercise protocol pre and post CRT implant|
16068101|NCT02396875|Procedure|Peripheral blood sampling|
16068102|NCT02396875|Procedure|Central blood sampling pre and post CRT implant|
16068103|NCT02396875|Procedure|Central blood sampling on one occasion and exercise protocol and 6 month peripheral sampling|
16068104|NCT02396862|Drug|Available Recombinant, and Human Factor VIII products incl. Kogenate FS (Recombinant Factor VIII, BAY14-2222)|Recombinant and Human Factor VIII / Used on demand or prophylaxis of bleeds
16068105|NCT02396849|Device|Continuous Positive Airway Pressure (CPAP)|Subjects assigned to this group will be asked to use the CPAP machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks.
16068106|NCT02396849|Device|Continuous Positive Airway Pressure (CPAP) Sham|Subjects assigned to this group will be asked to use the CPAP Sham machine for a minimum of 4 hours/night at least 5 days/week for a total of 4 weeks.
16068107|NCT02396836|Other|6 step technique|Hand decontamination with alcohol hand rub using the World Health Organizations 6 step technique
16068108|NCT02396836|Other|3 step technique|Hand decontamination with alcohol hand rub using the 3 step technique
16068493|NCT02393859|Drug|Daunorubicin|30 mg/m^2 IV over 24 hours on Day 5
16068109|NCT02396823|Behavioral|Respiratory Muscle Training|Standard threshold Positive Expiratory Pressure Device and threshold Inspiratory Muscle Trainer assembled together using a T-shaped connector with flanged mouthpiece will be used. The participants will be instructed to perform inspiratory and expiratory efforts against a resistive load. Training session lasts 45 minutes per day, 5 days per week, for 4 weeks.
16068110|NCT02396810|Other|intra-operative MRI|Intra-operative magnetic resonance imaging under general anesthesia
16068111|NCT02396810|Procedure|Transsphenoidal resection of pituitary macroadenoma|Routine transsphenoidal resection of pituitary macro adenomas
16068112|NCT02396797|Behavioral|The new atWork intervention|"atWork is a cognitive intervention, and uses a nondirective delivery approach. It does not prescribe any change in lifestyle, but aims at establishing an understanding of common complaints and what to do when pain and health complaints occur. All information is based on the non-injury model, where pain and complaints are not signs of injury caused by wrongdoing or inappropriate behavior. The consistent take home message from all parts of the intervention is that keeping up usual activities, including going to work, is beneficial for health and recovery. This group will receive one management course, two workplace courses for all employees targeting mild mental disorders and nonspecific musculoskeletal complaints, and one reflection and review meeting."
16068113|NCT02396797|Behavioral|The original atWork intervention|This group will receive three workplace courses for all employees targeting nonspecific musculoskeletal complaints, and peer support. Peer support involves selecting a peer advisor at the workplace. A peer advisor is a fellow worker without former medical training who as part of the atWork intervention receive more in-depth medical knowledge and training about nonspecific musculoskeletal complaints. The peer advisors role is to give social support and to use their local knowledge of the work place to facilitate staying at work for colleagues with health complaints.
16068114|NCT02396771|Procedure|Uterine Massage|The massage will be performed as follows: palpating the uterine fundus, manually stimulating the fundus and the whole body of the uterus using fingers and palms steadily and repetitively.
16068115|NCT02396771|Procedure|Uterine Compression|The sustained uterine compression will be performed as follows: placing one hand in the vagina and pushing against the body of the uterus while the other hand compresses the fundus from above through the abdominal wall.
16068116|NCT02396758|Device|Ekosonic® Endovascular Device ultrasonic infusion catheter|r-tPA will be administered via EKOS.
16068117|NCT02396758|Biological|Recombinant tissue plasminogen activator|Recombinant tissue plasminogen activator will be administered as per the dose and schedule specified in the arm.
16068118|NCT02396745|Device|Subjects undergoing TECR with ECM placement (ACell MatriStem, Boston Scientific WallFlex))|"TECR will be performed to resect the entire length and area of BE lesion.
~ECM PLACEMENT:
~Following resection, the exposed area will be covered with a 6 ply sheet of ACell MatriStem® Surgical Matrix PSMX ECM (ACell Inc., Columbia, MA). The ECM will be placed and held in position for 14 days (±4 days) using a Boston Scientific WallFlex™ Fully Covered Esophageal Stent (Boston Scientific, Boston, MA)."
16068119|NCT02396732|Drug|Aspirin|Daily dose is 81 mg oral tablet
16068120|NCT02396732|Drug|Enoxaparin|Daily dose is by subcutaneous injection and weight based at the discretion of the treating clinician.
16068121|NCT02396719|Device|LenSx® Laser|Used for cornea incision, capsulotomy and lens fragmentation during cataract surgery
16068122|NCT02396706|Drug|Ivy Leaves Cough Liquid|
16068123|NCT02396706|Drug|Placebo|
16068124|NCT02396693|Device|NIPPV|Ventilation with nasal intermittent positive pressure - Newborns randomized to this group underwent NIPPV, the respirators in TIME mode, set with the following settings : 5-6 centimeters of water (cmH2O) pressure positive end expiratory (PEEP); Flow rate of 6-8 liters per minute (L / min); PIP(positive inspiratory pressure) < 15 centimeters of water (cm H2O) ; respiratory frequency backup (FR) < 16 bpm; inspiratory time (IT) - 0.30 to 0.33 seconds (adjustable time constant according to the weight and baseline disease)
16068125|NCT02396693|Device|Bubble NCPAP|Bubble NCPAP - Newborns randomized to this group bubble NCPAP, adjusted with the following settings: pressure positive end expiratory (PEEP) 5-6 centimeters of water (cm H2O) and Flow 6-8 liters per minute (L / min), provided through oxygen sources and compressed air (15 liters per minute - L / min), which passes through a heated humidifier through a breathing circuit that goes to the newborn, and from him, for a plastic container (250 milliliters (ml) capacity and 14 centimeters) containing sterile distilled water, which is the bubble.
16068126|NCT02396693|Device|Ventilator NCPAP|Ventilator NCPAP - Newborns randomized to this group ventilator NCPAP, of respirators in TIME mode set with the following settings: pressure positive end expiratory (PEEP) 5-6 centimeters of water (cm H2O) and Flow 6-8 liters per minute (L / min).
16068127|NCT02396667|Other|5D ultrasound|Measure the femur length by 5DLB to calculate fetal weight
16068128|NCT02396654|Other|2D and 5D LB ultrasound comparison for fetal weight estimation|2D and 5DUS LB will be done for term pregnant women and fetal weight will be estimated by the hadlock formula. Accuracy of estimated fetal weight by both techniques will be compared to actual birth weight.
16068129|NCT02396641|Other|Best Supportive Care Checklist|
16068130|NCT02396628|Drug|Experimental intervention|Treatment with Ruxolitinib at a dose of 10 mg BID orally addition to BAT according DGHO-Onkopedia guidelines
16068131|NCT02396628|Drug|Standard treatment|Treatment according to DGHO-Onkopedia guidelines for treatment of acute GvHD (as of March 2018). Optional cross over from BAT to Ruxolitinib and BAT in case of lack of response from day 28.
16068132|NCT02396615|Dietary Supplement|SATIN pineapple|Active juice with added fibre and ginseng
16068133|NCT02396615|Dietary Supplement|SATIN pineapple control|Control products without active ingredients
16068134|NCT02396602|Behavioral|miPlan intervention|miPlan mobile contraceptive counseling waiting room app intervention
16068135|NCT02396589|Behavioral|Education Group|Attention will be provided to the control group to ensure they experience the same effects of time and attention but no effect on the outcome of interest.
16068136|NCT02396589|Behavioral|Home Modifications Group|The standardized components include assessment, identification of five problematic activities (and environmental barriers), identification of three solutions (for each problem), implementation of a solution set selected by the participant, training, and active practice of daily activities in one's own home and community.
16068211|NCT02396043|Drug|reinduction phase2|Cyclophosphamide: 1000 mg/m2 iv on days 29,Cytarabine: 75 mg/m2 iv on days 31-34, 38-41,Mercaptopurine: 60 mg/m2 po on days 29-42
16068137|NCT02396576|Behavioral|Telehealth Intervention|The telehealth model will integrate developmental, behavioral, (DB) and mental health services (MH) into pediatric primary care using videoconferencing that will be tested with children in low-income, urban communities.
16068138|NCT02396563|Procedure|epidural analgesia|
16068139|NCT02396563|Drug|Ropivacaine|
16068140|NCT02396550|Behavioral|Positive Expectations|Give positive expectation of the treatment efficacy to patients
16068141|NCT02396550|Procedure|Mobilization with movement|Give neutral expectation of the treatment efficacy to patients
16068142|NCT02396537|Drug|Lidocaine|Administered intranasally prior to Midazolam administration.
16068143|NCT02396537|Drug|Midazolam|Administered to all patients immediately after study drug (Lidocaine or Placebo) administered.
16068144|NCT02396537|Drug|0.9% Saline|Administered intranasally prior to Midazolam administration.
16068145|NCT02396524|Behavioral|Hockey FIT Program|Active phase: a) Classroom-based education on successful weight management strategies and instruction on behaviour change techniques/dietary interventions; promote peer and other forms of social support; and b) Physical activity sessions in aerobic/strength/flexibility exercises. Maintenance phase: Participants independently set new lifestyle prescriptions and goals and track their exercise, physical activity, and healthy eating with the support of a suite of free-of-charge health technology support tools
16068146|NCT02396511|Biological|TRC105|weekly i.v. TRC105 in combination with every 2 weeks i.v.bevacizumab, until progression or unacceptable toxicity develops
16068147|NCT02396511|Biological|Bevacizumab|Every 2 weeks i.v.bevacizumab in combination with weekly i.v. TRC105, until progression or unacceptable toxicity develops
16068148|NCT02396498|Drug|HIPEC|Using cisplatin in HIPEC plus oral S-1
16068149|NCT02396485|Other|Regular diet within 6hrs postoperative|Patients will be randomized to regular diet within 6 hrs postoperative (Early group) versus remaining nothing per os (NPO, i.e nothing per mouth) for 12hrs, and the diet then advanced as tolerated after 12hrs (Routine Group) as standard postoperative protocol in the investigators' institution.
16068150|NCT02396472|Behavioral|Order by time and topic|
16068151|NCT02396472|Behavioral|Order by information relevance|
16068152|NCT02396472|Behavioral|Order by social relationship|
16068153|NCT02396472|Behavioral|Order by help giving|
16068154|NCT02396472|Behavioral|Order by self-disclosure|
16068155|NCT02396459|Drug|Triac|Triac, individually titrated dose
16068156|NCT02396446|Other|Abdominal acoustic measurement|Device meant to listen to the sounds of the gut to determine post op ileus.
16068157|NCT02396433|Drug|Carboplatin|Carboplatin will be given on day 1 of each cycle.
16068158|NCT02396433|Drug|Eribulin|Eribulin will be given on days 1 and 8 of each cycle.
16068159|NCT02396433|Drug|E7449|E7449 will be given daily (days 1-21) during each cycle. Patients will continue to receive treatment until progression of disease or discontinuation due to unacceptable side effects.
16068160|NCT02396420|Device|Embosphere Microspheres|
16068161|NCT02396407|Behavioral|Combined water, sanitation, and hygiene|"Water: Free chlorine tablets (Aquatabs; NaDCC) and safe storage vessel to treat and store drinking water.
~Sanitation: Free child potties, sani-scoop hoes to remove feces from household, and latrine upgrades to a dual pit latrine for all households in study compounds.
~Handwashing: Handwashing stations including soapy water bottles and detergent soap.
~Local promoters visit study compounds at least monthly to deliver behavior change messages that focus on (1) treating drinking water for children < 36 months of age, (2) use of latrines for defecation and the removal of human and animal feces from the compound, and (3) handwashing with soap at critical times around food preparation, defecation, and contact with feces."
16068162|NCT02396394|Behavioral|Two-Step Adherence Feedback|Intervention subjects will use an electronic pill container to hold their antiretroviral medications. Throughout the 6-month intervention (until subjects are 3 months post-partum), whenever an intervention subject fails to open her electronic pill container within 60 minutes of dose time (as indicated by lack of a pill container opening), she will be sent a text message reminder. Each intervention subject will also participate in monthly counseling sessions informed by the subject's most recent adherence data generated by the electronic pill container. The counselor will review the adherence report with the patient and 1) provide positive feedback when adherence is ≥95% in the previous month, or 2) discuss reasons for lapses and strategies for improving adherence when adherence is <95%.
16068163|NCT02396381|Other|THS 2.2|Ad libitum use of THS 2.2 in an ambulatory setting for 26 weeks
16068164|NCT02396381|Other|CC|Ad libitum use of CC in an ambulatory setting for 26 weeks
16068165|NCT02396368|Drug|Tasquinimod|Tasquinimod is a quinoline-3-carboxamide analog that has demonstrated significant improvements in progression-free survival and overall survival in men with CRPC in a phase II trial.Tasquinimod will be administered at three dose levels (dose levels 1, 2, and -1). During dose level 1, tasquinimod will start at 0.25mg/day orally with a goal of 0.5mg/day. Dose level 2 will start at 0.25mg/day with a goal of 1mg/day. Dose level -1 will be 0.25mg/day without dose titration.
16068166|NCT02396368|Radiation|Radium 223|Radium Ra 223 dichloride, an alpha particle-emitting pharmaceutical, is a radiotherapeutic drug. Radium 223 is supplied as a clear, colorless, isotonic, and sterile solution to be administered intravenously with pH between 6 and 8. Each milliliter of solution contains 1,000 kBq radium-223 dichloride (27 microcurie), corresponding to 0.53 ng radium-223, at the reference date. Radium is present in the solution as a free divalent cation.Radium-223 will be administered per FDA-approved dosing (six IV injections at a dose of 50kBq/kg of body weight, administered every 4 weeks).
16068167|NCT02396355|Device|Investigational BD FACSPresto System|Blood samples will be tested on the BD FACSPresto system for CD4 absolute count (CD4Abs), %CD4, and Hb concentration.
16068168|NCT02396355|Device|BD FACSCalibur flow cytometer|Blood samples will be tested on the predicate, currently marketed device. For CD4Abs and %CD4 measurement, the BD FACSCalibur flow cytometer will be used with BD Multiset software version 1.1 or later and BD Tritest CD3/CD4/CD45 reagent with Trucount tubes.
16068169|NCT02396355|Device|Sysmex hematology analyzer KX-21|Blood samples will be tested for hemoglobic concentration on the predicate, currently marketed Sysmex hematology analyzer KX-21
16068170|NCT02396342|Genetic|AAV5-hFIX|AAV5hFIX gene therapy
16068171|NCT02396329|Drug|Chlorhexidine|
16068172|NCT02396329|Drug|Povidone-Iodine|
16068494|NCT02393859|Drug|Methotrexate|1 g/m^2 IV over 36 hours on Day 1
16068173|NCT02396316|Drug|Aflibercept (Eylea, BAY 86-5321)|After the first aflibercept IVT injection on Day 1, subjects may receive sham injection at Week 1, and aflibercept injection at Week 5 and/or Week 9 if the re-treatment criteria are met.
16068174|NCT02396316|Drug|Sham Injection|After the first sham injection on Day 1, subjects may receive aflibercept IVT injection at Week 1, Week 5 and/or Week 9 if re-treatment criteria are met.
16068175|NCT02396303|Drug|Carbetocin|
16068176|NCT02396290|Procedure|fractional carbon dioxide laser with platelet rich plasma|fractional carbon dioxide laser followed by platelet rich plasma injection
16068177|NCT02396290|Procedure|fractional carbon dioxide laser with NS|fractional carbon dioxide laser followed by normal saline injection
16068178|NCT02396277|Procedure|Immobilization|This is not an intervention study; but the patients are subjected to immobilization with a cast as part of a regular clinical treatment for distal radius fracture.
16068179|NCT02396264|Other|mediterranean diet|50 pcos women will be assigned to normocaloric mediterranean diet for 6 months
16068180|NCT02396264|Other|normocaloric diet|50 pcos women will be assigned to standardized normocaloric diet for 6 months
16068181|NCT02396251|Device|HA experimental|
16068182|NCT02396251|Device|HA comparator|
16068183|NCT02396238|Device|Celution Device|ADRCs prepared using the investigational Celution Device
16068184|NCT02396238|Other|Placebo|Placebo
16068185|NCT02396225|Drug|Voriconazole|
16068186|NCT02396212|Biological|Canakinumab|canakinumab was provided as a 150 mg/1 mL solution for subcutaneous injection and administered at 4mg/kg every 4 weeks.
16068187|NCT02396199|Device|Zenith® p-Branch® in combination with the Atrium iCAST™ covered stents|Instead of making a large incision in the abdomen, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
16068188|NCT02396186|Device|PTCA Balloon Angioplasty|
16068189|NCT02396173|Other|Risk Score for non-return to work|"The WORRK tool will be filled in for all patients, even the patients in the control group. However, the probability score will only be accessible for the medical doctors in the intervention group, along with guidelines for interpretation (1. With a probability score over 50% (not to return to work), patient's allocation to the Evaluation Pathway should be considered 2. With a probability score over 70% (not to return to work), the Evaluation Pathway is probably the most suitable choice)."
16068190|NCT02396160|Dietary Supplement|Urox|Active treatment - Proprietary combination of Crateva nurvala, Equisetum arvense and Lindera aggregata herbs
16068191|NCT02396160|Other|Placebo|Placebo - Identical vegetarian capsule containing color-matched cellulose to that of the active treatment
16068192|NCT02396147|Drug|TAK-385 T2 Formulation|TAK-385 T2 Formulation tablets
16068193|NCT02396147|Drug|TAK-385 T4 Formulation B|TAK-385 T4 Formulation B tablets
16068194|NCT02396147|Drug|TAK-385 T4 Formulation C|TAK-385 T4 Formulation C tablets
16068195|NCT02396134|Biological|CMVpp65-A*0201 peptide vaccine|Given SC
16068196|NCT02396134|Other|Placebo|Given SC
16068197|NCT02396134|Other|Laboratory Biomarker Analysis|Correlative studies
16068198|NCT02396121|Dietary Supplement|Oral nutritional supplement : Renutryl® Booster|
16068199|NCT02396108|Drug|Paclitaxel + Carboplatin + ASLAN001|"Phase I
~IV Paclitaxel 80mg/m2, day 1, 8, 15 of a 21-day cycle
~IV Carboplatin AUC of 1.5, day 1, 8, 15 of a 21-day cycle
~PO ASLAN001 daily continuously (starting dose 500mg BID)
~Phase II
~•PO ASLAN 001 daily continuously at the recommended phase II dose x 2 weeks
~Followed by:
~IV Paclitaxel 80mg/m2, day 1, 8, 15 of a 21-day cycle x 4 cycles
~IV Carboplatin AUC of 1.5, day 1, 8, 15 of a 21-day cycle x 4 cycles
~PO ASLAN001 daily continuously at the recommended phase II dose x 12 weeks"
16068200|NCT02396082|Behavioral|MIND-S Intervention|MIND at Home is a home-based, care coordination that focuses on persons with dementia living at home and their family caregivers. Its goal is to help persons age in place safely while increasing quality of life. Delivered over 18 months, MIND systematically assesses and addresses unmet care needs of persons with dementia and their caregivers which are known to be linked to poor health and quality of life outcomes, and that put people at risk for long term care placement. The needs addressed in the MIND program cover a wide range of care domains, ranging from home and medication safety, to cognitive and behavior symptoms management, meaningful activities and legal considerations. The care team made up of a memory care coordinator, nurse, and physician. Patients and families receive care coordination assistance, resource referrals, dementia care education and behavior management skills training, emotional support and problem-solving, and home safety education
16068201|NCT02396082|Other|Augmented Usual Care|Augmented usual care consists of an initial full in-home needs assessment for dementia-related needs and a written report that identifies unmet needs and provides recommendations for care sent to the participant and the primary care physician. Augmented usual care participants also receive an Aging and Caregiver Resource Guide that includes program and contact information for several local and national aging service organizations (e.g., Alzheimer's Association, Administration on Aging, Centers for Medicare and Medicaid). This condition likely exceeds the usual level of intervention in primary care settings
16068202|NCT02396069|Drug|JPI-289|PARP-1 inhibitor
16068203|NCT02396069|Drug|Placebo|Placebo
16068204|NCT02396056|Other|BioMend Extend|Biomend Extend is a resorbable collagen membrane used for guided tissue and bone regeneration.
16068205|NCT02396056|Other|Modified BioMend Extend|Biomend Extend is a resorbable collagen membrane used for guided tissue and bone regeneration. This membrane will be perforated to allow the passage of cells and growth factors that can potentially enhanced bone augmentation.
16068206|NCT02396043|Drug|induction phase1|"Vincristine: 1.5 mg/m2 (max 2 mg) iv on days1, 8, 15, 22,Pirarubicin: 30 mg/m2 iv on days1, 8, 15, 22,Prednisone: 60 mg/m2 po on days 1-28.
~Pegaspargase :3750U/m2 im on days 8,22"
16068207|NCT02396043|Drug|induction phase2|Cyclophosphamide: 1000 mg/m2 iv on days 35, 59,Cytarabine: 75 mg/m2 iv on days 35-38, 42-45, 49-52, 56-59,Mercaptopurine: 60 mg/m2 po on days 35-59
16068208|NCT02396043|Drug|protocol M|Methotrexate: 5 g/m2 d 8, 22, 36, 50;Mercaptopurine:25 mg/m2 1-56
16068209|NCT02396043|Drug|maintenance therapy|6-mercaptopurine , 50 mg/m 2 daily, and Methotrexate, 20 mg/m 2 once a week.The treatment lasted 2.0 years.Note that there were four additional doses of HD-MTX(5 g/m2 ) every 3 months during the maintenance phase
16068210|NCT02396043|Drug|reinduction phase1|"Vincristine: 1.5 mg/m2 (max 2 mg) iv on days1, 8, 15, 22,Pirarubicin: 30 mg/m2 iv on days1, 8, 15, 22,Prednisone: 60 mg/m2 po on days 1-28.
~Pegaspargase :3750U/m2 im on days 8"
16068213|NCT02396030|Drug|Magnesium sulfate 50% - 1g/h|Patients will receive after the loading dose os magnesium sulfate, the maintenance dose of 1g/hour of intravenous of magnesium sulfate for 24 hours after loading dose
16068214|NCT02396030|Drug|Magnesium sulfate 50% - 2g/h|Patients will receive after the loading dose os magnesium sulfate, the maintenance dose of 1g/hour of intravenous of magnesium sulfate for 24 hours after loading dose
16068215|NCT02396017|Device|Capsule endoscopy|Endoscopic device
16068216|NCT02396017|Drug|Polyethylene Glycol|Bowel purgative
16068217|NCT02396004|Device|Near Infrared Red Spectroscopy (NIRS)|NIRS using INVOS cerebral/somatic oximeter
16068218|NCT02395991|Drug|gadoxetic acid|standard dose of gadoxetic acid (0.025mmol/kg) intravenous administration
16068219|NCT02395991|Other|Magnetic resonance imaging (MRI)|"Dynamic T1 weighted sequence consist of precontrast, arterial, portal, transitional and hepatobiliary phases.
~precontrast, arterial and portal phases (prior to contrast media injection to 60 seconds after contrast media injection) are obtained continuously in free-breathing state. Transitional and hepatobiliary phases are obtained in breath-hold state."
16068220|NCT02395978|Drug|PDC-1421 Capsule|PDC-1421 Capsule is a botanical investigational new drug containing the extract of Radix Polygalae (Polygala tenuifolia Willd.) as active ingredient.
16068221|NCT02395978|Drug|placebo|Placebo contained corn starch.
16068222|NCT02395952|Drug|carboxymethylcellulose sodium|frequent topical lubrication with artificial tears
16068223|NCT02395952|Device|Acuvue Oasys Bandage Contact Lens|
16068224|NCT02395952|Device|Ambiodisk|
16068225|NCT02395952|Device|Prokera|
16068226|NCT02395939|Procedure|CT guided core biopsy|CT guided biopsy will be performed by a trained interventional radiologist using core biopsy.
16068227|NCT02395939|Procedure|Cryo-biopsy via Radial EBUS navigation|Cryo-biopsy will be performed via R-EBUS guidance. Cryo biopsy probe will be applied for 4 seconds for each biopsy and a minimum of 3 biopsies will be performed . Each patient will also have 3 forceps biopsies. The order of forceps biopsy or cryo biopsy will be randomly allocated.
16068228|NCT02395926|Drug|Choline CR 600mg|HT-003 600mg, administration 2 times per 1 day 8:00 a.m., 20:00
16068229|NCT02395926|Drug|Gliatilin 400mg|Gliatilin soft capsule 400mg, administration 3 times per 1day 8:00 a.m., 14:00, 20:00
16068230|NCT02395926|Drug|Choline CR 600mg|HT-003 600mg*2tab, administration 1 times per 1 day 8:00 a.m.
16068231|NCT02395913|Drug|Surfolase capsule (100mg)|Surfolase capsule one capsule twice one days fasting administration
16068232|NCT02395913|Drug|Surfolase CR (200mg, T1)|one tablet once one days fasting administration.
16068233|NCT02395913|Drug|Surfolase CR (200mg, T3)|one tablet once one days fasting administration.
16068234|NCT02395913|Drug|Surfolase CR (200mg, T4)|one tablet once one days fasting administration.
16068235|NCT02395900|Dietary Supplement|Flaxseed|
16068236|NCT02395900|Other|control|
16068237|NCT02395874|Procedure|tDCS + speech therapy|Patients either receive 20min of tDCS with 2mA + speech therapy every work for 6 weeks. The anodal electrode will be placed either on the homologous speech area (TACS) in the right hemisphere or on the speech area perilesional in the left hemisphere (PACS). The cathodal electrode will be placed contralateral. Patients in group B will follow the same protocol, except for the stimulation intensity (2 mA versus 0 mA) the speech therapist will apply the tdcs according to the protocol. The tdcs machine is out of sight of the patient, so that she/he does not see, whether the machine is switched on or not. In case of sham stimulation the device will be switched on very slowly for the first 20 s and will than be set back to 0mA within the following 10 s. So that the patient will feel also the characteristic tingling under the electrodes.
16068238|NCT02395861|Other|neuro-electrophysiologic analyses|mismatch negativity (MMN) cognitive evoked potentials (CEP) auditory evoked potentials (AEP)
16068239|NCT02395848|Drug|Fidaxomicin|200mg twice daily for 10 days followed by 200mg once daily for 20 days to prevent future recurrence of CDI
16068240|NCT02395822|Biological|IL-15|"Preparative Regimen:
~Fludarabine 25 mg/m2 x 5 days start day -6 Cyclophosphamide 60 mg/kg x 2 days on day -5 and -4 (if < 4 months from prior transplant, omit day -4 dose)
~IL-15 Activated Donor NK Cells:
~The apheresis product (collected day -1) will be enriched for NK cells with the large-scale CliniMacs® device (Miltenyi) by depletion of CD3+ cells to remove T-lymphocytes and depletion of CD19+ cells to remove B-lymphocytes. The NK cell enriched product will be activated by overnight incubation with10 ng/ml IL-15 under GMP conditions and infused on day 0.
~IL-15 to Facilitate NK Cell Survival and Expansion:
~IL-15 at 2 mcg/kg subcutaneously (SC) beginning day +1, once a day for 5 days followed by a 2 day rest, and then once a day for 5 days for 10 doses total"
16068241|NCT02395809|Procedure|lateral internal sphincterotomy|
16068242|NCT02395809|Procedure|TENS|
16068243|NCT02395796|Procedure|Epidural Pressure Waveform|When loss of resistance occurs, a high-pressure tubing extension will be connected to the needle and the pressure will be transduced and the waveform, recorded. An epidural catheter will then be passed through the needle and connected to a high-pressure tubing extension and the pressure will be transduced and recorded. A test dose of 3 mL of 2% lidocaine with epinephrine 1:200.000 will then be given to exclude potential spinal or intravascular injection. After 3 minutes, a loading dose of 10 mL of 0,125% bupivacaine will be given for labor analgesia and the presence or absence of a bilateral sensorial block at T10 or higher at 30 min will be assessed.
16068244|NCT02395783|Drug|Melatonin 10 µg|Determine the dose of prenatal administration of melatonin in preterm labor to reduce brain damage in the white matter detected by diffusion tensor imaging (DTI) analysis with spatial statistics (TBSS) to the theoretical term 40 weeks
16068245|NCT02395783|Drug|Melatonin 20 µg|Determine the dose of prenatal administration of melatonin in preterm labor to reduce brain damage in the white matter detected by diffusion tensor imaging (DTI) analysis with spatial statistics (TBSS) to the theoretical term 40 weeks
16068246|NCT02395783|Other|Placebo|Determine the dose of prenatal administration of melatonin in preterm labor to reduce brain damage in the white matter detected by diffusion tensor imaging (DTI) analysis with spatial statistics (TBSS) to the theoretical term 40 weeks
16068495|NCT02393859|Drug|Ifosfamide|800 mg/m^2 IV for 1 hour on Days 2-4
16068247|NCT02395770|Other|Rehabilitation program|"Movement training: To re-educate control of movement, exercises of increasing difficulty in terms of movement plane, range of motion, speed and resistance were performed.
~Strengthening: Using extremities weight, free weights or elastic bands, scapulothoracic and scapulohumeral strengthening was performed to increase strength and control of shoulder muscles.
~Stretching & Manual Therapy: These modalities, performed only if needed, were aimed at addressing stiffness of posterior and inferior glenohumeral capsule and pectoralis minor.
~Patient education: Participants received education regarding posture and body mechanics. They were instructed on preferred shoulder positioning during sleep, activities, work and sports"
16068248|NCT02395757|Device|MAIA™ (Centervue, Padova, Italy; distributed in France by EDC Lamy, Carvin, France)|"An automatic microperimetry exam of the 10° central macular coverage expert test (customized grid) will be performed with the MAIA™ device at each semi-annual follow-up visit."
16068249|NCT02395744|Other|Paclitaxel administration using the OPC|
16068250|NCT02395731|Behavioral|MIND at Home-Plus Intervention|MIND at Home-Plus is a home-based, care coordination that focuses on persons with dementia living at home and their family caregivers. Its goal is to help persons age in place safely while increasing quality of life. Delivered over 18 months, MIND-Plus systematically assesses and addresses unmet care needs of persons with dementia and their caregivers which are known to be linked to poor health and quality of life outcomes, and that put people at risk for long term care placement. The needs addressed in the MIND program cover a wide range of care domains, ranging from home and medication safety, to cognitive and behavior symptoms management, meaningful activities and legal considerations. The care team made up of a memory care coordinator, nurse, occupational therapist, and physician.
16068251|NCT02395718|Other|QDU|Treatment in a QDU. Intervention being fast track model for diagnostics and treatment with a goal of accomplishing a short-term hospitalisation (see description QDU arm)
16068252|NCT02395718|Other|DIM|Treatment at a ward at the DIM. Traditional inward hospitalisation
16068253|NCT02395705|Drug|cisplatin and paclitaxel|"Paclitaxel, 175mg/m2, d1, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles.
~Paclitaxel, 87.5mg/m2, d1,d8, Cisplatin, 25mg/m2, d2-d4, 3 week, 2 cycles.
~Paclitaxel, 175mg/m2, d1, Cisplatin, 75mg/m2, d1, 3 week, 2 cycles."
16068254|NCT02395692|Other|Treatment|Correlative studies
16068255|NCT02395692|Drug|Methoxyamine|Given PO
16068256|NCT02395692|Drug|Temozolomide|Given PO
16068257|NCT02395679|Biological|MesoCancerVac|A leukapheresis is performed of which the monocytes are used for differentiation to DCs using specific cytokines. Pulsed autologous DCs (MesoCancerVac) are re-injected 3 times every two weeks. After the third injection with MesoCancerVac, revaccinations to boost the immune system are given after 3 and 6 months.
16068258|NCT02395666|Drug|DFMO|Subjects will receive twenty-seven (27) cycles of oral DFMO at a dose of 500 to 1000 mg/m2 BID on each day of a 28 day cycle.
16068259|NCT02395653|Drug|fentanyl|An opioid that has been administered parenterally as an anesthetic and analgesic for more than 20 years.
16068263|NCT02395627|Drug|Tamoxifen|
16068264|NCT02395627|Drug|Vorinostat|
16068265|NCT02395627|Drug|Pembrolizumab|
16068266|NCT02395614|Drug|Chlorhexidine irrigation|- 0.05% chlorhexidine solution (IrriSept®) commercially prepared in 450 ml bottles will be used to irrigate one breast pocket. Each patient will receive triple antibiotic solution on one breast and the CHG on the other breast.
16068267|NCT02395614|Drug|triple antibiotic irrigation|"-triple antibiotic solution will contain 1 g of cefazolin, 50,000 U of bacitracin, and. Each patient will receive triple antibiotic solution on one breast and the CHG on the other breast.
~80 mg of gentamicin in 500 mL of NS. If the patient is allergic to either component - the allergen will not be used in the solution - to irrigate one breast pocket"
16068268|NCT02395601|Drug|CPI-1205|Small molecule inhibitor of the enzyme EZH2
16068269|NCT02395588|Other|Guideline based care|Patient education using guideline based teaching guides
16068270|NCT02395549|Drug|0.375% (w/w) MTC896 Gel|0.375% (w/w) MTC896 Gel
16068271|NCT02395549|Drug|0.75% (w/w) MTC896 Gel|0.75% (w/w) MTC896 Gel
16068272|NCT02395549|Drug|1.5% (w/w) MTC896 Gel|1.5% (w/w) MTC896 Gel
16068273|NCT02395549|Drug|Vehicle Control Gel|
16068274|NCT02395536|Other|office setting|An office setting was defined as a procedure or office room with controlled entry and hard floors outside the walls of the hospital and not including ambulatory surgical centers
16068275|NCT02395536|Other|hosptial setting|A hospital setting was defined as an operating room or electrophysiology lab inside the walls of a hospital.
16068276|NCT02395523|Radiation|Proton Beam Therapy|"Definition of target volume:
~Gross tumor volume (GTV) = gross tumor defined using a treatment planning CT scan
~Clinical target volume (CTV) = GTV + internal target volume
~Planning target volume (PTV) = CTV + 5 - 7 mm of lateral, craniocaudal, and anteroposterior margins.
~Radiation dose and planning
~Prescription dose to PTV: 70 GyE /10 fx, 7GyE fraction dose, 5 days/week
~Dose prescription : 95% isodose volume of prescribed dose encompassed PTV"
16068277|NCT02395510|Drug|Vortioxetine|Vortioxetine 5-20mg
16068278|NCT02395497|Biological|Monoclonal Antibody (Humanized Anti-CD52)|
16068279|NCT02395497|Drug|Tacrolimus|
16068280|NCT02395497|Procedure|Penile Allotransplantation|
16068281|NCT02395471|Device|Cytosponge™ Cell Collection Device|Cytosponge™ Cell Collection Device is indicated for use in the collection and retrieval of surface cells in the esophagus.
16068282|NCT02395458|Drug|Sequential therapy|Patient receive Omeprazole plus amoxicillin during 5 days and then omeprazole plus clarithromycin and metronidazole during another 5 days
16068283|NCT02395458|Drug|Triple therapy|Patient receive Omeprazole plus amoxicillin and Clarithromycin during 14 days
16068284|NCT02395445|Device|orotracheal intubation|
16068285|NCT02395432|Device|orotracheal intubation|
16068286|NCT02395419|Device|Orotracheal intubation with Totaltrack|
16068287|NCT02395419|Device|Orotracheal intubation with Airtraq|
16068288|NCT02395406|Device|Orotracheal intubation with Totaltrack|
16068289|NCT02395406|Device|Orotracheal intubation with Airtraq|
16068290|NCT02395393|Device|Alveoflex Confocal MiniprobeTM|-Alveolar imaging
16068291|NCT02395380|Other|C-reactive protein dosage|
16068295|NCT02395354|Device|Placing a self-expanding metallic stent|"Income on short stay unit (SSU) post-procedure
~Light sedation by the endoscopist vs anesthetist by center
~Fully covered self-expanding metal stents Tae Woong Medical® type; prosthesis size at the endoscopist discretion
~Clips can be placed at the distal end of the prosthesis according to the endoscopist.
~Prosthesis removal time in 4 weeks."
16068296|NCT02395354|Device|A balloon dilatation|"Income on short stay unit (SSU) post-procedure
~Light sedation by the endoscopist vs anesthetist by center.
~Pneumatic ball type CRE Boston cientific®; balloon diameter at the endoscopist discretion
~Up to 2 expansion will be made with a minimum interval between 15-30 days between each expansion
~It shall be deemed failure to expansion if required> 2 expansions."
16068297|NCT02395328|Behavioral|Care Worker Home Visitation|Primary services include biweekly home visits from Care Workers trained, mobilized and supported by Futures Families, a South African non-government organization working to support OVC in six townships within the greater Tshwane area (also known as Pretoria) of South Africa.
16068298|NCT02395315|Device|Well-controlled diabetic (WC)|Each individual will receive one implant (4.1 Titanium-Zirconia, hydrophilic-Roxolid), that will be placed in the posterior mandible.
16068299|NCT02395315|Device|Poorly controlled diabetics (PC)|Each individual will receive one implant (4.1 Titanium-Zirconia, hydrophilic-Roxolid), that will be placed in the posterior mandible.
16068300|NCT02395302|Device|Dual Action Pneumatic Compression|Wear in sustained mode for 14 hours and pneumatic compression mode for 3 hours during the 4 week treatment period.
16068301|NCT02395289|Behavioral|Cognitive-Based Compassion Training (CBCT)|"Cognitive-Based Compassion Training (CBCT) is composed of secular, didactic instruction and meditation practices. CBCT includes the meditative practices of developing one-pointed concentration and mindfulness. CBCT will be one class per week, 2 hours each, for 8 weeks, for a total of 16 hours during the study. Each meditation class will include a didactic and discussion session that will describe the meditative technique introduced during the week and a practice meditation session. The training protocol is highly iterative and techniques introduced early in training are practiced daily. All participants will be asked to meditate approximately 30 minutes a day at home and will be given a meditation diary to record amount of time spent meditating per week."
16068302|NCT02395289|Behavioral|Health discussion|Health discussion therapy is one class per week, 2 hours each, for 8 weeks. Each class will use interactive teaching methods to present the health material in an engaging and relevant manner. Representative weekly topics that will be covered include healthy diet, the role of exercise in emotional health, and the importance of sleep and relaxation. It is important to note that the material presented in the health discussion group, although intended to be beneficial to participants, does not include a contemplative component and is not iterative in nature.
16068303|NCT02395276|Device|Whole body hypothermia|Treatment will be initiated within 6 hours of the event, the child will be dressed with a cooling suit and their temperature will be monitored. Cooling will be to 33 +/- 1 °C . Treatment period will be 48 hours with 24 hours warming up period.
16068304|NCT02395263|Drug|Yuxintine|
16068305|NCT02395250|Biological|anti-GPC3 CAR T|
16068306|NCT02395237|Drug|: Amaryl® M IR 2/1000|
16068307|NCT02395224|Other|cancer treatment and follow-up according to current regional and national guidelines|
16068308|NCT02395211|Behavioral|Usual Physiotherapy|"Usual physiotherapy consist of active or passive mobilization, extensor digiti and carpi functional electric stimulation, occupational therapy and taping.
~The intervention will last 30 minute a day x 4 weeks"
16068309|NCT02395211|Device|Gloreha device|Proprioceptive stimulation under visual feedback are provided by the Gloreha device. The intervention will last 30 minute a day x 4 weeks
16068310|NCT02395185|Other|Milk bottle administration|Patients are given a bottle of milk during the casting process.
16068311|NCT02395185|Other|Water bottle administration|Patients are given a bottle of water during the casting process.
16068312|NCT02395185|Other|Sucrose bottle administration|Patients are given a bottle of sucrose during the casting process.
16068313|NCT02395172|Drug|Avelumab|Participants received 10 milligrams per kilogram (mg/kg) of avelumab as a 1-hour intravenous infusion once every 2 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled.
16068314|NCT02395172|Drug|Docetaxel|Participants received 75 mg per square meter (m^2) (per label) of docetaxel by intravenous infusion once every 3 weeks until confirmed disease progression, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the study or Investigational Medicinal Product (IMP) as defined in the study protocol was fulfilled.
16068315|NCT02395159|Device|Prevena™ IMS|"Prevena™ IMS is intended for the management of the surgical incision environment and surrounding healthy skin in patients with a risk of postoperative complications such as infections. This entails the maintenance of a closed environment around the incision by applying a negative pressure wound therapy system.
~The corresponding dressing is known under the name Prevena™ Dressing. The layer closest to the skin comprises silver foil, which reduces the microbial colonisation of cells."
16068316|NCT02395159|Other|sterile plaster dressings|standard wound management method of sterile plaster dressings
16068317|NCT02395146|Procedure|Monitoring|intraoperative EBSLN monitoring
16068318|NCT02395133|Drug|Dupilumab|Subcutaneous injection of Dupilumab 300 mg alternatively with placebo (matched to Dupilumab) was administered.
16068319|NCT02395133|Drug|Placebo|Subcutaneous injection of Placebo (for Dupilumab) was administered once weekly (QW).
16068320|NCT02395120|Behavioral|Standard letter|Standard referral letter according to Ohio Department of Health Bureau guidelines. This letter is consistent with others used across the country.
16068321|NCT02395120|Behavioral|Intervention letter|Referral letter based on the Common Sense Model of Self-Regulation (CSM). The letter includes the cognitive dimensions of the CSM (identity, cause, timeline, consequences and control).
16068322|NCT02395120|Behavioral|Reduced intervention letter|"Reduced (removing text corresponding to timeline) CSM theory-based referral letter. The letter includes the remaining cognitive dimensions of the CSM (identity, cause, consequences and control)."
16068438|NCT02394314|Drug|Placebo|Placebo administered subcutaneously
16068323|NCT02395120|Behavioral|DIG|Dental information guide (DIG) to reinforce/change illness perception, knowledge about dental caries, and resources to seek care. DIG is a brochure with illustrations which provides myths and facts about dental caries, hints for getting dental care, making appointments and Medicaid access, transportation and dentist availability resources.
16068324|NCT02395120|Behavioral|Reduced DIG|"Text and illustrations related to the timeline construct of the CSM have been removed in the reduced dental information guide."
16068325|NCT02395094|Behavioral|Child Life|"Child Life preparation in surgical daycare can include:
~role-play using dolls and medical equipment (either toy doctor kits or true medical materials)
~the use of books/storyboards that show pictures of operating room and daycare routines
~teaching & rehearsing coping and relaxation skills such as deep breathing and guided imagery
~age-appropriate explanation of what to expect throughout the day in SDCU"
16068326|NCT02395081|Dietary Supplement|600 IU Vitamin D3 in prenatal vitamin|Women will receive 600 IU 25(OH)D in prenatal vitamin.
16068327|NCT02395081|Dietary Supplement|2000 IU Vitamin D3 in prenatal vitamin|Women will receive 2000 IU 25(OH)D in prenatal vitamin.
16068328|NCT02395081|Dietary Supplement|4000 IU Vitamin D3 in prenatal vitamin|Women will receive 4000 IU 25(OH)D in prenatal vitamin.
16068329|NCT02395068|Drug|Nimotuzumab|single dose of nimotuzumab (100、200、400、600mg), with 3 weeks observation；Set 4 dose groups for Nimotuzumab, namely 100,200,400,600mg. Each group administered once a week for 6 weeks；600mg, administered once every 2 weeks for 8 weeks.
16068330|NCT02395068|Drug|irinotecan|"Single-dose PK：1 week after nimotuzumb administration, irinotecan (CPT-11) will be given at a dose of 180 mg/m2 once every 2 weeks, 2 weeks a cycle.
~Bioweekly fixed dose PK：Nimotuzumab combined with irinotecan (180mg/m2), administering once every 2 weeks and considering 2 weeks as a period. If chemotherapy and Nimotuzumab are administered in the same day, chemotherapy should be infused after Nimotuzumab for at least 1h"
16068331|NCT02395055|Drug|Adalimumab (BCD-057)|Adalimumab is a monoclonal antibody against tumor necrosis factor alpha
16068332|NCT02395055|Drug|Adalimumab (Humira)|Adalimumab is a monoclonal antibody against tumor necrosis factor alpha
16068333|NCT02395042|Drug|LiRIS®|LiRIS® is a drug-device combination product which is placed in the bladder during cystoscopy and remains in the bladder, gradually releasing lidocaine until removed from the bladder via cystoscopy.
16068334|NCT02395042|Drug|LiRIS Placebo|LiRIS placebo is a drug-device combination product, matching the LiRIS® which is placed in the bladder during cystoscopy, remains in the bladder until removed from the bladder via cystoscopy
16068335|NCT02395029|Biological|Placental Matrix-Derived Mesenchymal Stem Cells (PMD-MSCs)|
16068336|NCT02395016|Drug|nimotuzumab|nimotuzumab,400mg/w，Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test.
16068337|NCT02395016|Drug|Gemcitabine|Gemcitabine，1000mg/m2，Intravenous infusion over 30 minutes,Once every three weeks, rest one week (d1,8,15; q28d), Every 4 weeks for a period,Until disease progression or intolerable toxicity or subjects ask to leave the test.
16068338|NCT02395016|Other|Placebo|Placebo，400mg/w，Intravenous infusion over 60 minutes,Until disease progression or intolerable toxicity or subjects ask to leave the test.
16068339|NCT02395003|Other|Palmitate Diet|Subject with high VAT/SAT ratio will be randomized to a high or low palmitate oil diet.
16068340|NCT02394990|Behavioral|Violence Brief Intervention|Strategies for self assessment of consequences of violent behavior and strategies for avoidance of violence
16068341|NCT02394990|Behavioral|ABI|
16068342|NCT02394977|Device|Compression with Feedback|"Patients in the intervention group received CPR in accordance to published guidelines using the CFA device per manufacturer instructions. The Cardio First Angel™ (CFA; INOTECH, Nubberg, Germany) is a lightweight device that consists of three components . Application of400 ± 30 Newtons of force (41 kg or 90 lb of pressure), which correlates toa sternum compression depth of 50-60 mm, is followed by an audible click sound to alert the rescuer to cease compression. The click sound is also audible upon spring decompression alerting the rescuer to resume compression. The device does not require an electrical power supply."
16068343|NCT02394977|Other|Standard chest compression|CPR in accordance with published international guidelines using standard manual chest compression.
16068344|NCT02394964|Other|Sample Collection|Sample collection of blood, stool, and buccal and skin swab samples will be collected at baseline, week 4, and week 8
16068345|NCT02394951|Drug|Pregabalin|Anticonvulsant
16068346|NCT02394951|Drug|Placebo|Identical, matching inactive substance
16068347|NCT02394938|Other|MUSIC|In addition to the standard care,patients assigned to the music group will listen recorded classical music. Music will be delivered with a mp3 Player and headphones Music will be listened by the patient in his home.The music play list will be formed by a classical repertoire.During the intervention patients will be recommended to listen to the music for 3 months. Also patients will be asked to listen to the music once or more than once per day, at any time, for a total of 30 minutes per day.Music will be listen at 50-60 decibels below the threshold of 85 db established for listening to portable media devices such as compact disc and MP3 players.Music in this protocol will have a tempo/rhythm in a range of 60-80 beats per minute (bpm).
16068348|NCT02394925|Device|Multifocal Test Contact lens|Used in a daily wear modality
16068349|NCT02394912|Device|vena cava filter implantation (LUMIFI with Crux VCF System)|
16068350|NCT02394899|Behavioral|Play therapy|Short films that have been developed to deliver a series of child development messages will be shown at the monthly visits. Nine modules of approximate length 3 minutes each have been developed and cover the topics: Love, Comforting baby, Talking to babies and children, Praise, Using bath time to play and learn, Looking at books, Simple toys mothers can make, Drawing and games, and Puzzles. Nurses at the Sickle cell Unit (SCU) will be trained to discuss the video messages with the mothers/caregivers, demonstrate activities they can do with their children and how to make simple toys from household materials. Mothers/caregivers will practice some of the activities and they will be encouraged to make them part of their daily routine.
16068439|NCT02394288|Procedure|Extremity orthopedic or trauma surgery|hip, leg, shoulder, arm
16068441|NCT02394262|Radiation|Coronary CT-angiography|Sequential CCTA after one year follow-up. The first CCTA will be performed in terms of diagnostic work-up (referral outpatient Cardiology department).
16068351|NCT02394899|Other|Problem solving skills|Problem solving therapy (PST) aims to empower patients or caregivers in attending to daily challenges. It is based on cognitive behavioural therapy and can be used in primary care settings. It encourages persons to use existing resources and skills to function better and find solutions to problems. It will be delivered in 6 sessions over the 6-week period and will last for about 30 minutes per session. The stages of PST are: identification of the problems; generating possible solutions; evaluating and implementing preferred solution; and evaluating to see if the solutions were successful. The parent/caregiver will be taught a process of problem solving with reference to general everyday problems as well as specific problems which may arise while parenting a child with SCD.
16068352|NCT02394886|Biological|ALLO-ASC-DFU|
16068353|NCT02394873|Biological|ALLO-ASC-DFU|Dressing for second-degree burn wound.
16068354|NCT02394860|Other|echo Doppler lower limbs|
16068355|NCT02394847|Drug|propofol|
16068356|NCT02394834|Drug|oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab|oxaliplatin (OXA), levofolinate calcium (l-LV), panitumumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion
16068357|NCT02394834|Drug|oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumab|oxaliplatin (OXA), levofolinate calcium (l-LV), bevacizumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion
16068358|NCT02394821|Drug|Polihexanide 2%|
16068359|NCT02394821|Drug|Metronidazole 0.8%|
16068360|NCT02394808|Device|senofilcon A|One fresh pair of contact lenses worn for 11 (+/-2) days, for a minimum of 6 hours per day
16068361|NCT02394808|Device|lotrafilcon B|One fresh pair of contact lenses worn for 11 (+/-2) days, for a minimum of 6 hours per day
16068362|NCT02394795|Drug|oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab|oxaliplatin (OXA), levofolinate calcium (l-LV), panitumumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion
16068363|NCT02394795|Drug|oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, bevacizumab|oxaliplatin (OXA), levofolinate calcium (l-LV), bevacizumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion
16068364|NCT02394782|Device|RebiSmart®2.0|Rebif (interferon beta-1a) will be administered by RebiSmart®2.0 as specified in Summary of Product Characteristics.
16068365|NCT02394782|Device|MSdialog™|Rebif (interferon beta-1a) will be administered by MSdialog™ as specified in Summary of Product Characteristics.
16068366|NCT02394769|Drug|Aspirin|
16068367|NCT02394769|Drug|Placebo for Aspirin|
16068368|NCT02394756|Device|Marketed Soft Contact lens|Replacement schedule every 2 weeks
16068369|NCT02394756|Device|AIR OPTIX® AQUA|Replacement schedule every 4 weeks
16068370|NCT02394756|Device|Biofinity®|Replacement schedule every 4 weeks
16068371|NCT02394743|Radiation|18FDG-PET|
16068372|NCT02394730|Drug|vorapaxar|2.5mg of vorapaxar taken orally once daily for 12 weeks
16068373|NCT02394730|Drug|Placebo|Sugar pill taken orally once daily for 12 weeks
16068374|NCT02394717|Behavioral|Healthy Eating and Physical Activity|Create partnerships with ASPs to help facilitate changes in programming to meet the National Afterschool Alliance's HEPA Standards.
16068375|NCT02394704|Other|Sensory attention training|"Participants will be instructed to attend to sensory stimuli and to press a button as quickly and accurately as possible while ruminating. Stimuli will consist of vibration via a wearable subwoofer or non-painful electrical muscle stimulation (10Hz biphasic current with a pulse width of 200us with rectangular 2 electrodes placed on the back near the shoulders) or vibratory stimulation with a vibroacoustic element placed on the back near the shoulders. Up to four sessions will be approximately 45 minutes, over the course of two weeks."
16068376|NCT02394691|Device|transcranial direct current stimulation|anodal transcranial direct current stimulation on the left dorsolateral prefrontal cortex for the anodal session and sham stimulation (5secondes of tDCS) for the sham session
16068377|NCT02394678|Device|AngioJet Thrombectomy System|Mechanical removal of blood, using a pressurised jet of water, from ventricles of patients suffering from intraventricular haemorrhage
16068378|NCT02394665|Radiation|Intensity Modulated Radiation Therapy|IMRT treatment will consist of 60 Gy in 30 fractions to PTV 60
16068379|NCT02394665|Drug|Temozolomide|"Concurrently during radiation therapy. Adjuvant therapy administered daily on days 1 - 5 for 12 cycles. One cycle = 28 days:
~Concurrent during Radiation Therapy: 75 mg/m^2 orally for 6 weeks;
~Post-radiation, adjuvant therapy: 150 mg/m^2 - 200 mg/m^2 orally daily on days 1 - 5 of each cycle."
16068380|NCT02394665|Behavioral|Functional Assessment of Cancer Therapy-Brain (FACT-Br)|FACT-Br Quality of Life (QOL) questionnaire to be completed by study patients as protocol specific timepoints
16068381|NCT02394665|Radiation|Stereotactic Radiosurgery Boost|"Patients will undergo SRS boost in a single fraction dose prior to IMRT treatment:
~HTV Maximum dimension vs. Prescribed Dose to HTV: ≤ 20 mm = 21 Gy; 21 mm - 30 mm = 18 Gy; 31 mm - 40 mm = 15 Gy."
16068382|NCT02394665|Radiation|Simultaneous Integrated Boost|Treatment shall consist of 60 Gy in 30 fractions to planning target volume (PTV) 60 and 75 Gy in 30 fractions to PTV 75.
16068383|NCT02394665|Device|3D MRSI|Three Dimensional Magnetic Resonance Spectroscopy Imaging (MRSI) during pre-treatment, week 3 during radiation therapy, end of radiation therapy; will include standard gadolinium enhanced MRI prior to cycle 1, 5, 9, and post cycle 12 of adjuvant temozolomide therapy, per protocol.
16068384|NCT02394652|Drug|Metformin|Metformin is an antidiabetic agent given orally.
16068385|NCT02394652|Drug|Cisplatin|Cisplatin is an antineoplastic agent given intravenously.
16068386|NCT02394652|Drug|FAZA|FAZA is an investigational imaging agent for positron emission tomography scans indicated for hypoxia.
16068387|NCT02394639|Other|video-EEG monitoring|
16068442|NCT02394262|Other|Assesment of biomarkers involved in atherothrombosis|Sequential assesment of atherothrombis biomarkers: baseline and at 1 year follow-up.
16068443|NCT02394249|Behavioral|Physical activity regime|Information already included in arm descriptions
16068444|NCT02394236|Other|Aerobic exercise training|"The continuous exercise training was performed on a treadmill with a 50-minutes duration and intensity at ventilatory anaerobic threshold.
~The interval exercise training consisted of 7 sets of 3 minutes at respiratory compensation point and 7 sets of 3 minutes of exercise at moderate intensity corresponding to the ventilatory anaerobic threshold totaling 42 minutes"
16068496|NCT02393859|Drug|PEG-asparaginase|1000 U/m^2 IV for 2 hours or intramuscularly (IM) on Day 6
16068388|NCT02394626|Procedure|Surgery followed by adjuvant second-line therapy|"Surgery:
~Surgery must take place between day 1 and 14 after study inclusion and within 21 days from the MRI on which recurrence was diagnosed. The modalities of surgery and the choice of pre- and intra-operative technical adjuncts is at the treating neurosurgery discretion. Surgery must take place between day 1 and 14 after study inclusion and within 21 days from the MRI on which recurrence was diagnosed. The modalities of surgery and the choice of pre- and intra-operative technical adjuncts is at the treating neurosurgery discretion. However, some form of intra-operative resection control (iMRI or intra-operative fluorescence) and function control (electrophysiology) should be available to the surgeon and used when warranted.
~Adjuvant second-line therapy:
~Patients will be seen after surgery by the treating neurooncologist. Modalities of adjuvant second-line therapy are individually defined according to local guidelines and are not stipulated by study protocol."
16068389|NCT02394626|Procedure|Second-line therapy alone|Patients randomized to the non-surgical cohort receive second-line therapy according to local guidelines. Modalities thereof are not stipulated by study protocol.
16068390|NCT02394613|Drug|ANX776|Single intravenous injection
16068391|NCT02394600|Drug|Grastek®|one tablet daily for four months
16068392|NCT02394600|Drug|Placebo|one tablet daily for four months
16068393|NCT02394587|Behavioral|Mindfulness-based Stress Reduction|A non-pharmacological approach to pain management.
16068394|NCT02394574|Other|Clean Cookstove|Ethanol
16068395|NCT02394574|Other|Traditional Cookstove|Firewood / Kerosene
16068396|NCT02394561|Biological|Secukinumab|Secukinumab was supplied as 150 mg solution in pre-filled syringe for subcutaneous injection
16068397|NCT02394548|Radiation|Contralateral Esophageal Sparing Technique (CEST)|Determine whether CEST decreases rate of severe acute esophagitis
16068398|NCT02394535|Drug|Capecitabine|Given PO
16068399|NCT02394535|Other|Laboratory Biomarker Analysis|Correlative studies
16068400|NCT02394535|Drug|Nab-paclitaxel|Given IV
16068401|NCT02394535|Other|Questionnaire Administration|Ancillary studies
16068402|NCT02394535|Radiation|Radiation Therapy|Undergo radiation therapy
16068403|NCT02394522|Device|Spatial Repellent product with active ingredient (SHIELD)|Spatial Repellent Product - Passive Emanator
16068404|NCT02394522|Device|Active Ingredient|Transfluthrin (Active ingredient)
16068405|NCT02394522|Device|Spatial Repellent product without active ingredient (SHIELD)|Spatial Repellent Product - Passive Emanator. The name of the product is SHIELD from SCJohnson
16068406|NCT02394509|Behavioral|Home Based Self-management and Cognitive Training Changes lives (HOBSCOTCH)|HOBSCOTCH is a home-based self-management program to treat cognitive symptoms and improve quality of life, while minimizing the barriers of access to care. The program is based on Problem Solving Therapy (PST) and teaches problem solving strategies and compensatory mechanisms to help manage cognitive dysfunction and enhance quality of life.
16068407|NCT02394496|Drug|Fulvestrant|Fulvestrant 500mg (2 x 5ml) im injections as a loading dose on Day 0, followed by 500mg (2x5ml) on Day 14 (+/- 3 days) , Day 28 (+/- 3 days) and every 28 Days (+/- 3 days) thereafter.
16068408|NCT02394496|Drug|Lapatinib|1500mg (TBD) O.S. qd
16068409|NCT02394496|Drug|Aromatase Inhibitors|as indicated in the Summary Product Characteristic
16068410|NCT02394496|Drug|Placebo Lapatinib|1500mg (TBD) O.S. qd
16068411|NCT02394483|Drug|F901318 safety|Safety assessments
16068412|NCT02394483|Drug|F901318 tolerability|Tolerability assessments
16068413|NCT02394483|Drug|F901318 pharmacokinetics|Pharmacokinetic assessments
16068414|NCT02394483|Other|Placebo safety|Safety assessments
16068415|NCT02394483|Other|Placebo tolerability|Placebo tolerability
16068416|NCT02394483|Other|Placebo pharmacokinetics|Plaacebo pharmacokinetics
16068417|NCT02394470|Other|Deuterium oxide dilution|Reference standard for total body water: deuterium oxide dilution by mass spectrometry
16068418|NCT02394470|Other|Bioimpedentiometry|Bioimpedentiometry: measurement of whole body and thoracic resistance and reactance
16068419|NCT02394470|Other|Lung and subcutaneous ultrasound|Ultrasound: semiquantitative scoring of lung congestion (B lines) and peripheral edema (subcutaneous echography of the ankle)
16068420|NCT02394457|Drug|Cosyntropin|Intravenous Drug Infusion over 1 hour and a half
16068421|NCT02394457|Procedure|Epidural Blood Patch|Blood drawn from subject and then same Blood placed into Epidural space by anesthesia personnel.
16068422|NCT02394444|Other|Triadic parent-infant Relationship Therapy (TRT)|22 sessions, including home visits twice per month during the first four months, followed by monthly consultations in the neonatology ward, up to corrected age of 18 months.
16068423|NCT02394431|Other|Cardiac echography|Ejection fraction measured by Teicholz and planimetry, diastolic function, tissular doppler, myocardiac performance index, global longitudinal strain measured by speckle tracking, arterial pulmonary hypertension, left ventricular hypertrophy.
16068424|NCT02394431|Other|Biological parameters|Hemoglobin levels, red cells, hematocrit, iron, ferritin
16068425|NCT02394431|Other|Clinical parameters|Blood transfusion number, severity of the sickle cell disease damage, evolution duration of the sickness
16068426|NCT02394418|Drug|Sevoflurane|Treatment of delirium by inhaled sevoflurane
16068427|NCT02394418|Drug|Propofol|Treatment of delirium by propofol i.v. infusion
16068428|NCT02394418|Drug|Dexmedetomidine|Treatment of delirium by dexmedetomidine i.v. infusion
16068429|NCT02394379|Device|Trulign™ Toric IOL|Trulign™ Toric Posterior Chamber IOL is a modified plate haptic lens
16068430|NCT02394366|Other|Original Healing Salve (OHS)|Topical salve (Puremedy, Inc.)
16068431|NCT02394366|Other|OHS base only|Olive and beeswax salve base
16068432|NCT02394353|Device|Transient hepatic elastography|
16068433|NCT02394340|Drug|Omeprazole 40 mg|Oral capsule to be taken as per the instructions regarding proper dosing technique.
16068434|NCT02394340|Drug|Luliconazole Cream 1%|Topical cream to be applied as per the instructions regarding proper study drug application technique.
16068435|NCT02394327|Device|7-Fr Pigtail type naso-cholecystic drainage tube (Liguory nasal biliary drainage set; Wilson-Cook Medical, Salem, NC, USA)|Endoscopic
16068436|NCT02394327|Device|7-Fr double pigtail plastic stent (Zimmon; Wilson-Cook Medical, Salem, NC, USA)|
16068437|NCT02394314|Drug|MEDI0382|MEDI0382 administered subcutaneously
16068445|NCT02394223|Procedure|Full Field Optical Coherence Tomography (FFOCT) procedure|TRUS Prostate biopsy are performed under the care procedure Pathological examination of these prostate biopsy with FFOCT procedure, as compared to standard pathological evaluation
16068446|NCT02394197|Drug|Chloroquine phosphate|use at operational doses by age group according to the Mexican guidelines for vector borne diseases
16068447|NCT02394197|Drug|primaquine|use at operational doses by age group according to the Mexican guidelines for vector borne diseases
16068448|NCT02394184|Procedure|transcatheter aortic valve replacement|
16068449|NCT02394171|Behavioral|Group Cohesion|See description in arm/group above
16068450|NCT02394158|Drug|Metformin|
16068451|NCT02394158|Drug|placebo|
16068452|NCT02394145|Drug|Ticagrelor|Patients with normal kidney function and ESRD on hemodialysis will be treated by ticagrelor 90mg twice a day for 14 days. After then, platelet reactivity will be assessed by light aggregometry and VerifyNow assay.
16068453|NCT02394145|Drug|Clopidogrel|Patients with normal kidney function and ESRD on hemodialysis will be treated by clopidogrel 75mg or 150mg once a day for 14 days. After then, platelet reactivity will be assessed by light aggregometry and VerifyNow assay.
16068454|NCT02394132|Drug|Imiquimod|
16068455|NCT02394132|Radiation|Radiotherapy|
16068456|NCT02394119|Drug|Ofatumumab|1500 mg/1.73m2, administered once diluted in 1000 ml of normal saline
16068457|NCT02394119|Drug|Rituximab|375 mg/m2, administered once diluted in 100/250/500 ml of normal saline for dosage respectively between 100-250 mg, 260-500 mg, 510-1000 mg.
16068458|NCT02394106|Drug|Ofatumumab|Ofatumumab 1500 mg/1.73m2 administered once, diluted in 1000 ml of normal saline
16068459|NCT02394106|Other|Placebo|Normal saline, 1000 ml, administered once
16068460|NCT02394093|Drug|Aspirin (Acetylsalicylic acid, BAYe4465)|One stick pack containing 500 mg acetylsalicylic acid dry powder
16068461|NCT02394093|Drug|Aspirin (Acetylsalicylic acid, BAYe4465)|One tablet containing 500 mg acetylsalicylic acid
16068462|NCT02394093|Drug|Aspirin (Acetylsalicylic acid, BAYe4465)|One effervescent tablet containing 500 mg acetylsalicylic acid
16068463|NCT02394080|Device|Photodynamic Bone Stabilization System|Treatment of acute humerus fractures
16068464|NCT02394067|Other|Radiological Imaging|magnetic resonance imaging and magnetic resonance venography scans
16068465|NCT02394054|Drug|Intranasal vasopressin|Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 20 IU vasopressin (American Regent Pharmaceuticals). 5 puffs per nostril (1 puff = 2 IU vasopressin).
16068466|NCT02394054|Drug|Intranasal placebo|Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 5 puffs per nostril. Placebo consists of: 2 mls Glycerine and 3 mls purified water (methylparaben and propylparaben mixed according to purified water formula) for a total of 5 ml, which will be filtered with a 5mu filter.
16068467|NCT02394041|Device|Acupuncture|Method of acupuncture: check the condition of skin, disinfect if needed, insert sterile needles with special handling for each point, remove the needles after 15 minutes.
16068468|NCT02394041|Device|Sham acupuncture|Sham acupuncture with sham needles
16068469|NCT02394028|Drug|Etrolizumab|Etrolizumab will be administered as per regimen specified in individual arms.
16068470|NCT02394028|Drug|Placebo|Etrolizumab-matching placebo will be administered as per regimen specified in individual arms.
16068471|NCT02394015|Drug|Trabectedin and Pegylated Liposomal Doxorubicin|Trabectedin and Pegylated Liposomal Doxorubicin (PLD ) in the Treatment of Patients With Platinum-sensitive Recurrent Ovarian Cancer (ROC), according to SmPC from October 28, 2009 to October 31, 2014
16068472|NCT02394002|Drug|Propofol|
16068473|NCT02393989|Procedure|posterior restoration|restorations for caries effected teeth
16068474|NCT02393976|Dietary Supplement|IMMUNONUTRITION|IMMUNONUTRITION SUPLEMENTS PERIOPERATIVE
16068475|NCT02393976|Dietary Supplement|STANDART NUTRITION|STANDART NUTRITION PERIOPERATIVE
16068476|NCT02393963|Drug|Tranexamic Acid|0.5g Tranexamic Acid in 0.9% Sodium Chloride (study group) will be injected into the joint after final closure through a temporary catheter that is brought out through the incision.
16068477|NCT02393963|Other|Placebo|0.9% Sodium Chloride (placebo group) will be injected into the joint after final closure through a temporary catheter that is brought out through the incision.
16068478|NCT02393950|Drug|ODM-106|Single oral escalating doses of ODM-106 will be administered. Each subject will participate in 4 study periods and will therefore receive 3 single doses of ODM-106 and one single dose of placebo.
16068479|NCT02393950|Drug|Placebo|Single oral escalating doses of ODM-106 will be administered. Each subject will participate in 4 study periods and will therefore receive 3 single doses of ODM-106 and one single dose of placebo.
16068480|NCT02393937|Drug|Reference: Metronidazole Gel 1%|Participants are assigned to one of three groups in parallel for the duration of the study
16068481|NCT02393937|Drug|Test: Metronidazole Gel 1%|Participants are assigned to one of three groups in parallel for the duration of the study
16068482|NCT02393937|Drug|Placebo Gel|Participants are assigned to one of three groups in parallel for the duration of the study
16068483|NCT02393924|Other|No intervention|
16068484|NCT02393911|Dietary Supplement|Low Oxalate Diet|Low oxalate diet is a diet where products with oxalate will be eliminated, such as: tomatoes, berries, coffee, nuts
16068485|NCT02393898|Drug|Bevacizumab|Bevacizumab will be prescribed by the local clinician according to the SmPC and standard of care for up to 15 months. No treatment will be provided by the Sponsor in this non-interventional study.
16068486|NCT02393898|Drug|Carboplatin|Carboplatin will be prescribed by the local clinician according to local labeling and standard of care for up to 18 weeks. No treatment will be provided by the Sponsor in this non-interventional study.
16068487|NCT02393898|Drug|Paclitaxel|Paclitaxel will be prescribed by the local clinician according to local labeling and standard of care for up to 18 weeks. No treatment will be provided by the Sponsor in this non-interventional study.
16068488|NCT02393885|Device|AtriCure Bipolar System and AtriClip® PRO LAA Exclusion System, Endocardial Ablation|
16068489|NCT02393872|Behavioral|Feel4Diabetes-intervention|Community-based intervention.
16068490|NCT02393859|Drug|Blinatumomab|15 μg/m^2/day as a continuous intravenous infusion (CIVI) for 4 weeks
16068491|NCT02393859|Drug|Dexamethasone|10 mg/m^2/day intravenous (IV) on Days 1-6
16068497|NCT02393859|Drug|Erwinia-asparaginase|In case of allergic reaction to PEG-asparaginase, participants could change to erwinia-asparaginase, 20,000 units/m2 every 48 hours for a total of 6 doses
16068498|NCT02393846|Drug|Ketoprofen gel|Topical ketoprofen as used in gel form.
16068499|NCT02393846|Drug|Placebo|Placebo gel which is identical in colour, form and smell compared to ketoprofen gel.
16068500|NCT02393833|Procedure|Blood samples collection|"Blood samples to be collected at the following time points:
~Baseline, (after the completion of induction chemotherapy and, if randomized to CM maintenance, before start of CM maintenance.)
~Months 12, 18 and 36 after start of induction chemotherapy
~At time of confirmatory evidence of progression"
16068501|NCT02393820|Drug|pazopanib|treatment will be given until progression or unacceptable toxicity .
16068502|NCT02393807|Drug|PF 06260414 solid dose formulation|Single dose of 30 mg PF-06260414 given under fed/fasted conditions
16068503|NCT02393807|Drug|PF-06260414 nanosuspension|Single dose of 30 mg PF-06260414 given under fasted conditions
16068504|NCT02393794|Drug|Romidepsin|Histone deacetylase inhibitor
16068505|NCT02393794|Drug|Cisplatin|Platinum compound
16068506|NCT02393794|Drug|Nivolumab|Monoclonal antibody, checkpoint inhibitor
16068507|NCT02393755|Drug|Capecitabine|Given PO
16068508|NCT02393755|Other|Laboratory Biomarker Analysis|Correlative studies
16068509|NCT02393755|Drug|Nintedanib|Given PO
16068510|NCT02393755|Other|Pharmacological Study|Correlative studies
16068511|NCT02393742|Drug|Sodium nitrite|
16068512|NCT02393742|Drug|Placebo|
16068513|NCT02393729|Behavioral|Neuropsychological assessment|"The neuropsychological assessment will include an assessment of:
~Intellectual ability
~Laterality
~Reading Skills
~Motor skills
~Oral Language
~Attention
~Child's behaviour"
16068514|NCT02393729|Other|MRI Study|"It will include a first session of about an hour outside MRI for familiarization with the environment of the MRI. The MRI will then be made after a break of 15 minutes
~Morphological time: this time include the initial acquisition of a sequence of anatomical 3D T1-weighted high-resolution contiguous axial slices and the imaging of diffusion tensor.
~Functional time: The experimental paradigm is a paradigm as a block with alternating phase of motor and rest conditions. The two motor tasks are: a Learning motor sequence or motor sequence task and Automated motor sequence or AT (automated task)."
16068515|NCT02393716|Device|Endurant Evo AAA Stent Graft System|
16068516|NCT02393716|Procedure|Endovascular aneurysm repair (EVAR)|
16068517|NCT02393690|Radiation|Iodine I-131|Given PO
16068518|NCT02393690|Other|Placebo Administration|Given PO
16068519|NCT02393690|Drug|Selumetinib|Given PO
16068520|NCT02393677|Drug|Ropivacaine|Ropivacaine 0.5% 30 ml was used to block brachial plexus
16068521|NCT02393677|Drug|Ropivacaine with Dexmedetomidine|Dexmedetomidine 1 microgram per kilogram bodyweight was added with 30 ml 0.5% Ropivacaine to block brachial plexus
16068522|NCT02393664|Drug|propofol, bupivacaine|Nonintubated technique for thoracoscopic surgery using propofol infusion, intercostal and vagal blocks with bupivacaine infiltrations.
16068523|NCT02393664|Drug|sevoflurane, rocuronium|Conventional intubated general anesthesia for thoracoscopic surgery using sevoflurane and rocuronium, and tracheal intubation with a double-lumen tube or a endobronchial blocker.
16068524|NCT02393651|Device|tDCS|Late LTP-like plasticity tDCS (2 times per week) for 4 weeks.
16068525|NCT02393638|Other|Simulation and lecture|Endoscopic sphincterotomy on simulator and lecture
16068526|NCT02393638|Other|Lecture|Lecture
16068527|NCT02393625|Drug|Ceritinib (LDK378)|
16068528|NCT02393625|Drug|Nivolumab|
16068529|NCT02393612|Drug|DP-R202|Sarpogrelate HCl SR 300mg is administrated to patients with PAD for 12 weeks
16068530|NCT02393612|Drug|Anplag tab|Anplag tab 100mg is administrated to patients with PAD for 12 weeks
16068531|NCT02393599|Drug|Lorcaserin|10 mg 2 times per day from Day 3 to 9 and one time on Day 10
16068532|NCT02393599|Drug|Placebo|10 mg 2 times per day from Day 3 to 9 and one time on Day 10
16068533|NCT02393599|Drug|Cocaine Infusion|Screening / Session 1, Study Day -2: 20 mg cocaine, followed by a saline infusion, followed by 40 mg cocaine Baseline/ Session 2, Study Day 1: Saline or 20 mg cocaine followed by either 20 mg cocaine or saline Baseline / Session 3, Study Day 2: Saline or 40 mg cocaine followed by either 40 mg cocaine or saline Treatment / Session 4, Study Day 9: Saline or 20 mg cocaine followed by either 20 mg cocaine or saline Treatment / Session 5, Study Day10: Saline or 40 mg cocaine followed by either 40 mg cocaine or saline
16068534|NCT02393586|Drug|Faropenem|Single oral dose
16068535|NCT02393586|Drug|Amoxicillin/clavulanic acid 500mg/125mg|Single oral dose
16068536|NCT02393586|Drug|Rifampicin|Single oral dose
16068537|NCT02393573|Drug|Metformin|Patients will take metformin for two weeks before Surgery and 2 days after the surgery
16068538|NCT02393573|Drug|Placebo|Patients will take Placebo pills for two weeks before Surgery and 2 days after the surgery
16068539|NCT02393560|Procedure|DECT scan|
16068540|NCT02393547|Drug|Varenicline|All subjects receive Varenicline
16068541|NCT02393547|Drug|Lorcaserin|All subjects receive Lorcaserin
16068542|NCT02393534|Other|Telephone Visit|Eligible patients that are randomized to the telephone follow-up arm will have their next medical visit with their primary care provider via a telephone call.
16068543|NCT02393521|Device|Shindo® vibration mattress|vibration therapy was self-administered while the subject was laying in supine in a polyurethane mattress
16068544|NCT02393508|Other|Fresh Human Red Blood Cells|Red cell units for transfusion will be acquired from Canadian Blood Services (CBS), as a part of their usual stock to the Calgary Zone. Blood will be processed and prepared by CBS according to their standard protocol. The red cell units assigned to patients as a part of this trial will not be manipulated in any way prior to participant transfusion.
16068545|NCT02393508|Other|Aged Human Red Blood Cells|Red cell units for transfusion will be acquired from Canadian Blood Services (CBS), as a part of their usual stock to the Calgary Zone. Blood will be processed and prepared by CBS according to their standard protocol. The red cell units assigned to patients as a part of this trial will not be manipulated in any way prior to participant transfusion.
16068546|NCT02393495|Device|intrauterine device TCu 380A|
16068547|NCT02393482|Drug|Estroprogestinic therapy (Etinil-estradiol/levonorgestre)|Etinil-estradiol/levonorgestrel (100 mcg/20 mcg)/die
16068548|NCT02393482|Drug|Gonadotropin-releasing hormone agonist (Leuprorelin acetate)|Leuprorelin acetate (3,75 mg/2 ml)/month
16068549|NCT02393482|Drug|Add back therapy 1 (tibolone)|tibolone 5 mg/die
16068550|NCT02393482|Drug|Add back therapy 2 (calcium carbonate/colecalciferol)|calcium carbonate/colecalciferol (500mg/400UI)/die
16068551|NCT02393469|Other|pulmonary rehabilitation|Exercises breathing exercises are performed on a cycle ergometer for 30 minutes, monitored by 50% of your maximum heart frequency, strengthening exercises for major muscle groups of the upper and lower limbs with charges based on 70% of one repetition maximum, muscle stretching test, and in expiratory pattern
16068552|NCT02393469|Other|Education and self-management for COPD|Two months of continuous and self management for COPD where patients know their disease, pathophysiology, treatment, exacerbation of symptoms, and better ways pharmacological treatment education will be conducted through a system of multidisciplinary lessons with professional Physiotherapists, Psychologists, Dieticians, Pharmacists , Physical Education Professionals and Doctors
16068553|NCT02393456|Drug|Intranasal oxytocin|Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 24 IU oxytocin (Syntocinon, Novartis Pharmaceuticals). 5 puffs per nostril (1 puff = 2.4 IU oxytocin).
16068554|NCT02393456|Drug|Intranasal placebo|Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 5 puffs per nostril. Placebo consists of: 2 mls Glycerine and 3 mls purified water (methylparaben and propylparaben mixed according to purified water formula) for a total of 5 ml, which will be filtered with a 5mu filter.
16068555|NCT02393443|Drug|Intranasal oxytocin|Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 24 IU oxytocin (Syntocinon, Novartis Pharmaceuticals). 5 puffs per nostril (1 puff = 2.4 IU oxytocin).
16068556|NCT02393443|Drug|Intranasal placebo|Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 5 puffs per nostril. Placebo consists of: 2 mls Glycerine and 3 mls purified water (methylparaben and propylparaben mixed according to purified water formula) for a total of 5 ml, which will be filtered with a 5mu filter.
16068557|NCT02393430|Drug|Rebamipide|Rebamipide is a
16068558|NCT02393430|Behavioral|optimization of life style|
16068559|NCT02393417|Biological|CANDIN|Candida albicans Skin Test Antigen for Cellular Hypersensitivity
16068560|NCT02393417|Other|Placebo|0.9% Sodium Chloride Injection USP (non-preserved)
16068561|NCT02393404|Other|PT-FMT|Physiotherapeutic functional movement-power training
16068562|NCT02393404|Other|FMT alone|Physiotherapeutic power training
16068563|NCT02393391|Device|Neuroelectrics STARSTIM|
16068564|NCT02393378|Drug|Namilumab|Namilumab injection
16068565|NCT02393378|Drug|Adalimumab|Adalimumab SC injection
16068566|NCT02393378|Drug|Methotrexate|Methotrexate tablet
16068567|NCT02393378|Drug|Folic Acid|Folic Acid Tablet
16068568|NCT02393365|Other|Questionnaire|All patients admitted to the one day clinic for surgery and gastroenterology will be asked, after signing an informed consent, to fill in a questionnaire about HCV risk factors.
16068569|NCT02393365|Procedure|HCV serology|"In case of a pre-operative blood sample an HCV serology will also be done as part of a routine pre-operative screening.
~In patients where no pre-operative blood sample is done an additional consent will be asked to perform a blood sample for HCV serology. This qualifies the study as 'interventional' according to the Belgian legislation."
16068570|NCT02393352|Other|Dry Needling Therapy|The dry needling therapy will be applied on active trigger points in occipital muscle, splenius capitis, sternocleidomastoid muscle, scalene muscles, trapezius, supraspinatus, infraspinatus muscle, latissimus dorsi, iliocostalis muscle, multifidus muscles, and quadratus lumbourm muscles.
16068571|NCT02393352|Other|Electrical Stimulation Therapy|
16068572|NCT02393339|Drug|paracetamol|Pre-operative administration of Paracetamol syrup
16068573|NCT02393339|Drug|placebo|Pre-operative administration of placebo syrup
16068574|NCT02393326|Procedure|partial pulpotomy with biodentine|After caries removal resulted in a pulp exposure, the pulp at the exposed area is amputated to a depth of 2 mm. The wound surface is irrigated and dried. After homeostasis is obtained, biodentine is gently applied to the wound surface, and then covered with reinforced zinc oxide-eugenol
16068575|NCT02393326|Procedure|Formocresol pulpotomy|Following removal of the coronal pulp and achievement of homeostasis, a cotton pellet moistened with formocresol (1: 5 Buckley's solution) is placed on the amputated pulp for 5 min. The pulp stumps is then covered by IRM.
16068576|NCT02393313|Procedure|Cataract surgery|Rayner T-flex Toric IOLs (573T / 623T; Rayner Intraocular Lenses Ltd,East Sussex, United Kingdom) will be implanted in the lens capsule
16068577|NCT02393313|Device|Rayner T-flex Toric IOLs|
16068578|NCT02393300|Drug|normal saline|The normal saline solution will be prepared under sterile conditions. In the operation room the sterile bag containing the solution will be given to the scrub nurse. The contents (60 ml) will be emptied in a sterile surgical bowl and the nurse will ask the surgeon to apply the solution before wound closure.The dosage and applying route can also be looked up in doctor's order sheet.
16068579|NCT02393300|Drug|Tranexamic Acid|The Tranexamic Acid solution will be prepared under sterile conditions. In the operation room the sterile bag containing the solution will be given to the scrub nurse. The contents (60 ml) will be emptied in a sterile surgical bowl and the nurse will ask the surgeon to apply the solution before wound closure.The dosage and applying route can also be looked up in doctor's order sheet.
16068580|NCT02393300|Drug|Tranexamic Acid|The Tranexamic Acid solution will be prepared under sterile conditions. In the operation room the sterile bag containing the solution will be given to the circuit nurse and the circuit nurse will ask the anesthetist to apply the solution intravenously before tourniquet deflation. The dosage and applying route can also be looked up in doctor's order sheet.
16068581|NCT02393287|Other|Eribulin (ReProLine)|this is an observational trial ; there is no intervention
16068582|NCT02393274|Device|Extra-corporeal membrane oxygenation life support|venoarterial extra-corporeal membrane oxygenation life support
16068583|NCT02393261|Other|2500ml Huaren peritoneal dialysate|use 2-3 bags of 2500ml Huaren dialysate in the daytime and keep 1 bag of 2500ml Huaren dialysate in the night
16068584|NCT02393261|Other|2000ml peritoneal dialysate|use 3-4 bags of normal 2000ml dialysate in the daytime and keep 1 bag of 2000ml dialysate in the night
16068585|NCT02393248|Drug|Pemigatinib|
16068586|NCT02393248|Drug|Gemcitabine + Cisplatin|
16068587|NCT02393248|Drug|Pembrolizumab|
16068588|NCT02393248|Drug|Docetaxel|
16068589|NCT02393248|Drug|Trastuzumab|
16068590|NCT02393248|Drug|INCMGA00012|
16068591|NCT02393235|Other|doppler ultrasonography|Ovarian, uterine and spiral artery pulsatility index and resistance index will measure
16068592|NCT02393222|Other|Observing effect of routine HD|Observing effect of routine HD via transcranial doppler, neurocognitive questionnaires and (in some) brain MRI
16068593|NCT02393209|Drug|Docetaxel|Docetaxel intravenous infusion
16068594|NCT02393209|Drug|TAK-117|TAK-117 Tablets
16068595|NCT02393196|Drug|hydroxyethyl starch (% 6 HES 130/0.4) (Voluven®)|Before spinal anesthesia
16068596|NCT02393196|Drug|hydroxyethyl starch (%6 HES 130/0.4) (Voluven®)|Just after spinal anesthesia
16068597|NCT02393183|Drug|ASTED|A tablet of ASTED will be taken twice a day
16068598|NCT02393183|Dietary Supplement|Selenium|A tablet of 100 microgram of Selenium (same shape and color) will be taken twice a day
16068599|NCT02393183|Other|Placebo|A tablet of Placebo (same shape and color) will be taken twice a day
16068600|NCT02393170|Other|self-training using video-games|"Individuals will receive a video-game console and will be taught how to play the games.
~They will be requested to play 60 minutes a day for 5 weeks."
16068601|NCT02393170|Other|traditional self-training|Individuals will receive a manual and equipment and will be taught how to perform the exercises. They will be requested to perform the exercises 60 minutes a day for 5 weeks.
16068602|NCT02393157|Drug|Obinutuzumab|Drug will be given alone in a pre-phase and in combination with ICE chemotherapy.
16068603|NCT02393157|Drug|Liposomal ARA-C|Will be given intrathecally for both prophylaxis and treatment of CNS disease.
16068604|NCT02393157|Drug|Ifosfamide|Ifosfamide 3000 mg/m2/day as a 2 hour IV infusion daily x 3 days (Days 0,1,2) of Cycle 1 and 2.
16068605|NCT02393157|Drug|Carboplatin|Carboplatin: 635 mg/m2 as 1 hour IV infusion on Day 0 only of Cycle 1 and 2.
16068606|NCT02393157|Drug|Etoposide|Etoposide: 100 mg/m2/day as 1 hour IV infusion daily x 3 days (Days 0,1,2).
16068607|NCT02393144|Device|Transperineal ultrasonography, General Electric Healthcare Voluson Ultrasound System|Assessment of cervical dilatation, angle of progression and head position via transperineal ultrasonography
16068608|NCT02393144|Device|Cardiotocography, Bionet FC1400 Fetal Monitor|Assessment of strength of uterine contractions (Montevideo units) and fetal heart rate (beat per minute) with electronic monitors.
16068609|NCT02393144|Other|Amniotomy|Artificial rupture of membranes to assess meconium staining and induce labor speed.
16068610|NCT02393144|Drug|Analgesics, Opioid, Meperidine|Administration of meperidine for labor analgesia.
16068611|NCT02393144|Drug|Labor augmentation, Oxytocin|Oxytocin infusion for augmentation of labor.
16068612|NCT02393144|Drug|Labor induction, Oxytocin|Oxytocin infusion for induction of labor.
16068613|NCT02393144|Drug|Cervical ripening, labor induction, Dinoprostone|Administration of dinoprostone pessary for cervical ripening and labor induction.
16068614|NCT02393131|Radiation|Hippocampal avoidance WBRT|Conformal Whole Brain Radiotherapy 30 Gy in 10 fractions with Hippocampal Avoidance using Intensity modulated radiotherapy, Volumetric arc therapy, or Tomotherapy
16068615|NCT02393131|Radiation|Conformal WBRT|Conformal Whole Brain Radiotherapy 30 Gy in 10 fractions with Hippocampal Avoidance using Intensity modulated radiotherapy, Volumetric arc therapy, or Tomotherapy
16068616|NCT02393118|Device|BrainPort V200 Device|Training in clinic on use of the device for 2-3 days (10 hours) followed by in-home use for a minimum of 300 minutes per month over 12 months.
16068617|NCT02393092|Behavioral|Brief Violence Awareness|The Brief Violence Awareness (BVA) will consist of a packet of information about violence prevention and local community resources.
16068618|NCT02393092|Behavioral|Brief Violence Prevention|The Brief Violence Prevention (BVP) will be a psycho-educational intervention administered by a case manager that will include an interactive discussion with youth regarding resources for remaining safe and preventing violence. The intervention will address the concerns and questions of youth and youth will be given information on how to access community based resources if needed.
16068619|NCT02393092|Behavioral|Emerging Leaders: East End curriculum|The Emerging Leaders: East End curriculum focuses on positive youth development and education, which includes an emphasis on health careers. The curriculum will be administered at the Boys and Girls Club of Metro Richmond, Martin Luther King Middle School site.
16068620|NCT02393079|Device|Transcranial LED Therapy (TCLT)|Whereas the geometry of the skull and to uniformly distribute the light radiation, the TLTC is applied using as light source a set of LEDs installed in a helmet, emitting radiation in the range between 600nm and 650nm with a peak at 630nm, so in the red region.
16068621|NCT02393079|Device|Sham|A SHAM identical helmet will be used in the control group.
16068622|NCT02393066|Drug|Propofol|Sedation
16068623|NCT02393066|Drug|Dexmedetomidine|Sedation
16068624|NCT02393053|Procedure|Treatment with subepithelial connective tissue graft (SCTG)|Miller Class I or II gingival recessions were treated with subepithelial connective tissue graft (SCTG)
16068625|NCT02393053|Procedure|Treatment with non-pedicled buccal fat pad graft (BFPG)|Miller Class I or II gingival recessions were treated with non-pedicled buccal fat pad graft (BFPG)
16068626|NCT02393040|Other|PRP/Saline|"PRP/Saline: Two groups were defined: group A and group B. Group A received treatment with PRP on the right half-head and placebo on the left half-head while group B received administration of PRP on left half-head and placebo on the right half-head.
~Same patient will be injected with PRP and a saline solution. Each patient will be injected on half-head."
16068627|NCT02393027|Drug|[18F] LBT-999 PET|
16068628|NCT02393014|Procedure|Simple physical exercises|"The participant must stay out of the bed 3 hours. This pre-required level prevents the occurrence of acute postural mismatch which can occur when elderly patients are bedridden and too long increases the risk of falling.
~The participant stands standing in static equilibrium to a chair holding the back of it for 2 minutes. Depending on the patient's abilities, the exercise will be done on both feet or one foot.
~The participant performs a transfer activity of sitting to standing repeated 5 times (FTSS test). According to the patient's abilities, the exercise will be done with physical assistance or not."
16068629|NCT02393001|Other|Dermatology patients|Cleanse an area of unafflicted (control) skin with a cotton 2 x 2 dampened with saline.
16068630|NCT02393001|Other|Dermatology patients|Cleanse a suspicious lesion (potential melanoma) with a saline cotton swab.
16068631|NCT02393001|Other|Dermatology patients|This intervention follows the standard of care for patients with a suspicious skin lesion (potential melanoma) the physician plans to biopsy. The alcohol swab used to prep the site will be stored for testing rather than discarded.
16068632|NCT02393001|Other|Dermatology patients|Cleanse an area of unafflicted (control) skin with an alcohol swab.
16068633|NCT02392988|Other|acupuncture treatment|acupuncture treatment
16068634|NCT02392988|Other|Placebo Comparator|Placebo Comparator
16068635|NCT02392975|Procedure|Fast MR|Enrolled subjects will undergo fast MR within 24 hours of CT completion. Subjects will be scanned using one of 2 Philips Ingenia MR 3T scanners. The estimated duration of the fast MR is less than 5 minutes, even if up to 2 sequences are repeated for motion.
16068636|NCT02392975|Procedure|Computed Tomography|The Investigator will recruit children in whom a head CT is ordered as standard of care for TBI. Consenting subjects will undergo fast MR shortly after CT and results will be compared.
16068637|NCT02392962|Procedure|Static Stretching|To analyze the immediate effects of static stretching on performance of sprinters
16068638|NCT02392962|Procedure|Dynamic Stretching|To analyze the immediate effects of dynamic stretching on performance of sprinters
16068639|NCT02392949|Behavioral|Passive mobilization|An anterior-posterior manual pressure act on the cervical spine of the subject
16068640|NCT02392949|Other|Placebo|The elbows will be put into a 90 deg elevated position and held for 5 secs, then back to resting position
16068641|NCT02392936|Procedure|Sternotomy for coronary artery bypass graft, valvuloplasty, aortic surgery or combined procedures, under extracorporeal circulation or not, in emergency or scheduled.|
16068642|NCT02392910|Drug|Iron Sucrose|At each visit, the patient lay on a stretcher and underwent a vein cannulation in the forearm with a commercial canula no. 16, which was connected to IV tubing that was connected to a bag contained 200 ml isotonic saline solution 0.9% plus 200 mg of Iron Sucrose. Each infusion was administered throughout 60 min. This scheme was followed for 5 consecutive weeks.
16068643|NCT02392910|Drug|Placebo|At each visit, the patient lay on a stretcher and underwent a vein cannulation in the forearm with a commercial canula no. 16, which was connected to IV tubing that was connected to a bag of isotonic saline solution 0.9% (200 ml). Each infusion was administered throughout 60 min. This scheme was followed for 5 consecutive weeks.
16068644|NCT02392897|Behavioral|High Eating Frequency|Free-living participants will complete a 21-day high eating frequency (high EF) Phase in which consume all daily energy at 6 eating occasions.
16068645|NCT02392897|Behavioral|Low Eating Frequency|Free-living participants will complete a 21-day low eating frequency (low EF) Phase
16068646|NCT02392884|Behavioral|Cognitive Rehabilitation|Provide cognitive techniques and teach compensatory strategies that subjects can use to help them remember to attend appointments, take their medications regularly, increase attention (conversational and task) and concentration, increase cognitive flexibility, develop better problem-solving skills.
16068647|NCT02392871|Radiation|Palliative radiotherapy|
16068648|NCT02392871|Drug|Dabrafenib and trametinib (combination)|Patients should be taking dabrafenib and trametinib for at least 2 weeks prior to enrolment into the study.
16068649|NCT02392858|Other|influenza cohort|Influenza is a major cause of morbidity and mortality. The investigators' first goal is to evaluate soluble HLA-G5 isoform serum level as a potential marker of greater risk of death from Influenza respiratory illness in adult and pediatric patients hospitalized in reanimation. Secondly, the investigators collected respiratory samples in order to study the transcriptomic profiles of influenza-infected patients with severe symptoms.
16068650|NCT02392845|Drug|Combination of Docetaxel (DTX) and Epirubicin (EPI)|Six cycles of densified DTX+EPI chemotherapy (2 weeks per cycle) for each patient
16068651|NCT02392832|Biological|Fourstar® granule, 90 day and 180 day briquettes Bti/Bs|"In 2015: Two sites each in Kakamega and Vihiga counties in western Kenya will be randomly selected and treated with larvicides (intervention) and the other two sites will serve as control (no-intervention). Temporary habitats will be treated with FourStar® controlled release granule formulation, semi-permanent habitats will be treated with 90 day briquettes, and permanent habitats with 180 day briquettes. No retreatment.
~Starts from 2016, a total of 34 clusters in the two study sites will be assigned to treatment or control by a block randomization method. The Bti treatment will be the same as in 2015. The retreatment interval will be 4-5 months. After the third treatment, no treatment will be performed for the next 8 months. After this, a cross over will be performed. Previous control sites will receive 3 rounds of the same LLML treatment at appropriate time intervals and previous treatment sites will not receive any LLMLs."
16068652|NCT02392819|Dietary Supplement|Panax ginseng|Pananx ginseng is provided prior to a standardised breakfast, effects on test variables are determined at fasting and repeatedly postprandially the breakfast
16068653|NCT02392819|Dietary Supplement|Placebo|
16068654|NCT02392806|Device|Bubble CPAP- BabiPlus, Respiralogics|Infant will be randomized to BabiPlus Bubbler at time of extubation
16068655|NCT02392806|Device|Bubble CPAP- B&B Bubbler, B&B Medical devices|Infant will be randomized to B&B Bubbler at time of extubation
16068656|NCT02392793|Drug|Talazoparib|Given orally once or twice on day 1 (depending on the dose level), then daily on days 2-6.
16068657|NCT02392793|Drug|Irinotecan|Given intravenously daily, days 2-6 immediately following the talazoparib dose.
16068658|NCT02392793|Drug|Temozolomide|Given orally daily. Dose to be determined after MTD established with talazoparib plus irinotecan.
16068659|NCT02392793|Drug|Filgrastim|Given subcutaneously (SubQ) once per day starting 24-36 hours after last dose of chemotherapy and continuing until post-nadir ANC is >2,000/μL, unless peg-filgrastim is given.
16068660|NCT02392793|Drug|Peg-filgrastim|Given subcutaneously (SubQ) once per day starting 24-36 hours after last dose of chemotherapy and continuing until post-nadir ANC is >2,000/μL, unless filgrastim is given.
16068661|NCT02392780|Drug|Cannabidiol|Oral cannabidiol at a dose of 150 mg BID up to 90 days.
16068662|NCT02392780|Drug|Methylprednisolone|IV methylprednisolone 2 mg/kg/day
16068663|NCT02392780|Drug|Calcineurin inhibitor|cyclosporine with dose adjusted based on drug trough levels (200-400 ng/ml) or tacrolimus with dose adjusted on drug trough levels (5-15 ng/ml)
16068702|NCT02392507|Drug|Nab-Paclitaxel|Administered IV
16068703|NCT02392507|Drug|Carboplatin|Administered IV
16068664|NCT02392767|Dietary Supplement|Verum|2400 mg L-arginine, 80 mg Pycnogenol, 45µg vitamine K2, 10 mg R (+) alpha lipoic acid, 8 mg vitamine B6, 500 µg vitamine B12, and 600 mg folic acid.
16068665|NCT02392767|Dietary Supplement|Placebo|corn starch
16068666|NCT02392754|Device|Screening: Intervention - Atrial fibrillation screening (ZIO XT ECG monitor, Watch-BP)|The intervention group receives AF screening with a 2-week ambulatory ECG patch monitor (ZIO XT Patch) worn at baseline and again at 3 months, in addition to standard care for 6 months. The intervention group also receives a home BP monitor with automatic AF detection capability to be used twice daily for 2 weeks during the ECG monitoring periods.
16068667|NCT02392741|Other|Physical exercise program|The intervention consists to an exercise program composed by a daily post prandial, 10' after breakfast, lunch and dinner, totaling 150' weekly, for eight weeks.
16068668|NCT02392728|Behavioral|Immersive Virtual Reality (VR)|Patients in this group will experience the virtual content (e.g., natural scenes) through a Head-Mounted-Display, simulating movement by manipulating a gesture controller. Following a resting period the patients will then experience the guided imagery session (e.g. visual images of pleasant scenery)
16068669|NCT02392728|Behavioral|Guided Imagery|Patients in this group will experience the guided imagery (e.g. visual images of pleasant scenery). Following a resting period the patients will then experience the virtual content (e.g., natural scenes) through a Head-Mounted-Display, simulating movement by manipulating a gesture controller
16068670|NCT02392715|Device|Inspiratory muscle training with Threshold by respironics|"Inspiratory muscle training
~15 minutes, 3x/weeks, 36 sessions
~Intensity: 15% of PiMax during the first week. Then increment of 5% each session until 60% of PiMax after the first month. The PiMax will be reassessed after 12 and 24 sessions in order to readjust the 60% of PiMax."
16068671|NCT02392715|Device|Sham Inspiratory muscle training|"with Threshold by respironics
~15 minutes, 3x/weeks, 36 sessions
~Intensity: 5 centimeters of water (cmH20)"
16068672|NCT02392702|Drug|C-10355|
16068673|NCT02392702|Drug|C-10358|
16068674|NCT02392702|Drug|Kalydeco|
16068675|NCT02392689|Other|Procalcitonin|Procalcitonin guided antibiotic therapy
16068676|NCT02392676|Drug|OLAPARIB|Patients should continue with therapy until objective radiological disease progression as per RECIST 1.1 despite rises in CA-125. All patients should continue to receive study treatment until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator or the patient experiences unacceptable toxicity or they meet any other discontinuation criteria
16068677|NCT02392676|Drug|PLACEBO|Patients should continue with therapy until objective radiological disease progression as per RECIST 1.1 despite rises in CA-125. All patients should continue to receive study treatment until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator or the patient experiences unacceptable toxicity or they meet any other discontinuation criteria
16068678|NCT02392663|Other|Hypertonic saline solution|All patients will perform 4 sessions during the same week. Each session will be include: inhalation period + bronchial drainage period. 20 minutes will be spent to perform the inhalation period. Moreover, 30 minutes will be spent to complete the bronchial drainage session post-inhalation.
16068679|NCT02392663|Other|Hyaneb solution|All patients will perform 4 sessions during the same week. Each session will be include: inhalation period + bronchial drainage period. 20 minutes will be spent to perform the inhalation period. Moreover, 30 minutes will be spent to complete the bronchial drainage session post-inhalation.
16068680|NCT02392663|Other|Isotonic saline solution|All patients will perform 4 sessions during the same week. Each session will be include: inhalation period + bronchial drainage period. 20 minutes will be spent to perform the inhalation period. Moreover, 30 minutes will be spent to complete the bronchial drainage session post-inhalation.
16068681|NCT02392637|Drug|Cisplatin|Given IV
16068682|NCT02392637|Drug|Gemcitabine Hydrochloride|Given IV
16068683|NCT02392637|Other|Laboratory Biomarker Analysis|Correlative studies
16068684|NCT02392637|Drug|Nab-paclitaxel|Given IV
16068685|NCT02392624|Drug|Omalizumab|Omalizumab 300 mg administered SC Q4W.
16068686|NCT02392624|Drug|Placebo|Placebo matched to omalizumab administered SC Q4W.
16068687|NCT02392611|Drug|Alobresib|Tablet administered orally once daily on Study Day 1 through Cycle 1 Day 28 of 28 days cycle
16068688|NCT02392611|Drug|Exemestane|Tablets administered orally once daily on Cycle 1 Day 1 of 28 days cycle
16068689|NCT02392611|Drug|Fulvestrant|Administered intramuscularly on Cycle 1 Day 1 of 28 days cycle and every 28 days
16068690|NCT02392585|Procedure|Single tourniquet|Single tourniquet is tourniquet applied uterine isthmus to occlude the uterine arteries. For this purpose, a small opening is made in the avascular place of the broad ligament on either side of the uterine isthmus superior to the uterine vessels. A pediatric Foley catheter is threaded through the two holes and tied tightly anteriorly around the cervix at the level of the internal os.
16068691|NCT02392585|Procedure|Triple tourniquet|"Triple tourniquet consist of two tourniquet applied both infundibulopelvic ligaments and one uterine isthmus to occlude the left and right ovarian vessels and to occlude the uterine arteries. For this purpose, a small opening is made in the avascular place of the broad ligament on either side of the uterine isthmus superior to the uterine vessels. A pediatric Foley catheter is threaded through the two holes and tied tightly anteriorly around the cervix at the level of the internal os.
~Through the same openings in the broad ligament each side a Foley catheter looped around the infundibulopelvic ligament lateral to the fallopian tube and ovary."
16068692|NCT02392572|Drug|ONC201|"Phase I Starting dose of ONC201: 125 mg by mouth once every 3 weeks.
~Phase II Starting dose of ONC201: MTD from Phase I."
16068693|NCT02392572|Drug|Cytarabine|20 mg subcutaneous twice daily for 10 days.
16068694|NCT02392559|Drug|Evolocumab|Dose of subcutaneous evolocumab every 4 weeks
16068695|NCT02392559|Drug|Placebo|Dose of subcutaneous placebo treatment every 4 weeks
16068696|NCT02392546|Drug|elobixibat|
16068697|NCT02392546|Drug|placebo|
16068698|NCT02392533|Other|Education|Education
16068699|NCT02392520|Drug|cetrorelix (cetrotide)|0.25 mg GnRH antagonist cetrorelix will be administered once daily for 4 days, starting on the day of severe early OHSS diagnosis
16068700|NCT02392520|Drug|Placebo|intravenous albumin administration, paracentesis of ascitic fluid, correction of electrolyte imbalance and intravascular volume
16068701|NCT02392507|Drug|Necitumumab|Administered IV
16068704|NCT02392494|Drug|MK-1075|MK-1075 supplied as 10 mg or 100 mg tablets for oral administration.
16068705|NCT02392481|Procedure|Biofluid sampling|
16068706|NCT02392468|Drug|BI 409306 matching placebo|placebo
16068707|NCT02392468|Drug|BI 409306 matching placebo|placebo
16068708|NCT02392468|Drug|BI 409306|low dose
16068709|NCT02392468|Drug|BI 409306|high dose
16068710|NCT02392455|Drug|treatment|Docetaxel plus nintedanib until progression or intolerability
16068711|NCT02392442|Other|Saline|Investigate the changes in miRNA signatures found in BAL and lung cells from healthy volunteers at baseline and at 6 hours after 1800 of normal Saline installed in six 30 mL aliquots into the left (lingual) and right (middle lobe) lung segments (360 mL total).
16068712|NCT02392442|Biological|Endotoxin|Investigate the changes in miRNA signatures found in BAL and lung cells from healthy volunteers at baseline and at 6, 24, or 48 hours after endotoxin segmental lung challenge.
16068713|NCT02392429|Drug|Chemotherapy|Given anthracycline IV
16068714|NCT02392429|Procedure|Computed Tomography|Undergo FLT PET/CT
16068715|NCT02392429|Drug|Cytarabine|Given IV
16068716|NCT02392429|Other|Fluorothymidine F-18|Undergo FLT PET/CT
16068717|NCT02392429|Other|Laboratory Biomarker Analysis|Correlative studies
16068718|NCT02392429|Procedure|Positron Emission Tomography|Undergo FLT PET/CT
16068719|NCT02392403|Device|Nucleus CI532 cochlear implant|
16068720|NCT02392390|Procedure|Topical Dynamic Phototherapy (TDP)|Metvixia cream is applied to the lesion (about 1mm thickness) and the treated zone is covered with an opaque dression for 3 hours. Any residual cream is removed an and the lesion immediately rinsed with saline solution when uncovering. One session (8 minutes) of phototherapy is then performed using an Altilite lamp in accordance with HAS (haute authorité de santé) recommendations.
16068721|NCT02392390|Drug|Metvixia cream|
16068722|NCT02392377|Drug|Paclitaxel|Given IV or IVPB
16068723|NCT02392377|Drug|Carboplatin|Given IV or IVPB
16068724|NCT02392377|Drug|Oxaliplatin|Given IV
16068725|NCT02392377|Drug|Leucovorin Calcium|Given IV
16068726|NCT02392377|Drug|Fluorouracil|Given IV
16068727|NCT02392377|Radiation|Radiation Therapy|Undergo radiation therapy
16068728|NCT02392377|Procedure|Therapeutic Conventional Surgery|Undergo esophagectomy
16068729|NCT02392377|Other|Laboratory Biomarker Analysis|Correlative studies
16068730|NCT02392364|Drug|Intravitreal Aflibercept Injection|
16068731|NCT02392351|Device|Renal Denervation (Vessix)|Percutaneous renal denervation using the Vessix Reduce™ Catheter and Vessix™ Generator
16068732|NCT02392351|Device|Renal Angiography|Percutaneous renal angiography
16068733|NCT02392338|Procedure|Hybrid procedure|Eletrophysiologic study via femoral vein approach to confirm pulmonary vein isolation lesion and box lesions in left atrium
16068734|NCT02392325|Biological|rDEN1Δ30|Administered subcutaneously in 0.5 mL containing 10^3.0 plaque-forming units (PFU)
16068735|NCT02392325|Biological|Placebo|Administered subcutaneously in 0.5 mL
16068736|NCT02392325|Biological|rDEN2Δ30-7169|Administered subcutaneously in 0.5 mL containing 10^3.0 PFU
16068737|NCT02392312|Drug|ATF-Fresenius S|intravenous
16068738|NCT02392286|Drug|Corticosteroid|Subjects will receive prednisone orally; if intravenous corticosteroid required initially they will receive methylprednisolone for the first 3-4 days of therapy.
16068739|NCT02392273|Drug|Ausanil|Patients with Primary Headache disorders will receive Ausanil in the context of usual and routine clinical care.
16068740|NCT02392260|Device|Vasculight|Comparative measre of Pulse Wave velocity with both Vasculight prototype and Echocardiographic machine.
16068741|NCT02392247|Device|Coagulation function|Coagulation function assessment tools TEG (standard of practice) vs SEER Quantra (novel coagulation function device)
16068742|NCT02392234|Drug|VX-661/Ivacaftor|Fixed dose combination tablet, oral use
16068743|NCT02392234|Drug|Ivacaftor|Tablet, oral use
16068744|NCT02392234|Drug|Placebo matched to VX-661/ ivacaftor|Fixed dose combination tablet, oral use
16068745|NCT02392234|Drug|Placebo matched to Ivacaftor|Tablet, oral use
16068746|NCT02392208|Drug|Telavancin|A single 5 mg/kg dose of telavancin is administered intravenously (IV).
16068747|NCT02392208|Procedure|Pharmacokinetic Blood Sampling|Blood samples are collected to assess telavancin plasma concentrations.
16068748|NCT02392195|Other|Non-interventional|Observational
16068749|NCT02392182|Other|Fiberoptic bronchoscopy|All subjects will undergo a research fiberoptic bronchoscopy under moderate conscious sedation. There is no randomization
16068750|NCT02392169|Drug|Methylphenidate|Patients used Retina or Concerta twice a day lasting for one year.
16068751|NCT02392156|Biological|rFVIIIFc|As described in the treatment arm
16068752|NCT02392156|Biological|rFIXFc|As described in the treatment arm
16068753|NCT02392156|Drug|non-Fc FVIII replacement products|Standard plasma-derived (pd) or recombinant (r) FVIII concentrate and other traditional treatment options
16068754|NCT02392156|Drug|non-Fc FIX replacement products|Standard plasma-derived (pd) or recombinant (r) FIX concentrate and other traditional treatment options
16068755|NCT02392143|Other|Printed Education Material|The printed education material described the importance of early detection and prevention, risk factors, and the importance of talking to your doctor about CRC screening. The PEM highlighted colonoscopy as being the only test that can identify and prevent CRC and described how to prepare for a colonoscopy beginning seven days prior to the test [18]. The PEM also described other CRC screening tests, including the FOBT, FIT, sigmoidoscopy, barium enema and virtual colonoscopy.
16068756|NCT02392143|Other|Academic Detailing|Academic detailing (AD) involved an in-person visit from a member of the research team who attempted to communicate strategies for improving CRC screening uptake in the practice's patient panel. A brief description of the RCT was followed by a semi-structured interview assessing usual practice regarding CRC screening referral and follow up. The direction of the discussion was guided by PCP responses. A variety of resources were provided. Specific directives were following up to make sure patients had made appointments with a gastroenterologist and offering home stool tests. The detailer attempted to elicit a verbal commitment to do at least one new thing to strengthen the probability that patients would be screened.
16069003|NCT02390375|Drug|Rosuvastatin|5mg F/U study: DW-0929 5/10mg
16068757|NCT02392143|Other|Academic Detailing+Telephone Education|PCPs received AD as described in the Academic Detailing arm. In addition, participants received tailored telephone education (TTE) which focused on identifying and addressing barriers that might impede screening. Verbal commitments were elicited to speak with their PCP and make an appointment for a colonoscopy, or request a home stool test, as appropriate. Follow-up calls assessed progress towards achieving goals.
16068758|NCT02392130|Drug|Clobetasol propionate 0.05% ointment|
16068759|NCT02392130|Drug|LEO 130852A gel 1%|
16068760|NCT02392130|Drug|LEO 130852A placebo gel|
16068761|NCT02392117|Drug|insulin degludec|Tresiba® will be prescribed by the physician under normal clinical practice conditions and will be obtained/ purchased from the chemist based on physician prescription. No treatment given.
16068762|NCT02392104|Drug|Warfarin|If the patient's INRs stay within goal range, their interval of INR follow-up will be extended based on a protocol to a maximum of 12 weeks.
16068763|NCT02392078|Device|NeuroBlate System|
16068764|NCT02392052|Behavioral|Reinvention Protocol Participants|A cognitive behavioral therapy (CBT), to enhance self-efficacy skills for caregivers of family members with SCI, with a focus on changing thinking styles to help people make emotional and behavioral changes.
16068765|NCT02392052|Behavioral|Wait List|This group will include individuals randomized to receive no treatment for the 18 weeks during which the interventional group will receive the active treatment and have their progress tracked.
16068766|NCT02392039|Drug|Pegfilgrastim|6 mg subcutaneously between 24 and 72 hours after completion of chemotherapy once per 21 day cycle.
16068767|NCT02392039|Drug|Loratadine|"Group 1 - Cycles 1 and 3: Loratadine 10 mg by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days.
~Group 2 - Cycle 2 and 4: Loratadine 10 mg by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days."
16068768|NCT02392039|Other|Placebo|"Group 1 - Cycle 2 and 4: Placebo by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days.
~Group 2 - Cycle 1 and 3 : Placebo by mouth daily, starting on the day of Pegfilgrastim administration and continuing for a total of 7 days."
16068769|NCT02392039|Behavioral|Questionnaires|Three questionnaires completed about bone pain and quality of life. These are completed before Pegfilgrastim received during Cycles 1 - 4 (and if participant has pain, during Cycles 6 - 7), on Day 7, and 8 weeks after last dose of study drugs.
16068770|NCT02392026|Drug|Metronidazole Gel|Metronidazole Vaginal Gel 1.3% administered via applicator
16068771|NCT02392013|Other|Home Modification|Removal of home barriers or hazards.
16068772|NCT02392000|Device|WatchPAT sleep monitor|Self-management of insomnia using a mobile sleep device
16068773|NCT02392000|Behavioral|CBT-i Coach mobile app|Self-management of insomnia using a mobile app based on Cognitive Behavioral Therapy for Insomnia
16068774|NCT02391987|Device|Tele-monitoring and health coaching|"Tele-monitoring involves a personal monitoring system used to analyze data to provide relevant health information back to the treating clinician and the user. The monitoring system remotely monitors electrocardiographic (ECG) signals, heart rate, breathing rate, and activity levels. Additional devices will be integrated with the monitoring device to assess blood pressure and weight.
~Health Coaching involves a team of health care professionals including a registered nurse (RN) . The health care team creates a plan specific to the patient and provides guidance on nutrition' medications, and exercise. The data collected by the remote monitoring device will assist the care team in patient management."
16068775|NCT02391974|Device|PERIOSYAL FILL|"Injection 2 weeks after standard periodontal treatment procedure on all teeth that need to be treated.
~Touch-up treatment provided at 3 and 6 weeks."
16068776|NCT02391961|Drug|Dalfampridine|10-week randomized, placebo controlled, double-blind, crossover trial, which includes a period of wash out of two weeks between treatment with dalfampridine and placebo.
16068777|NCT02391961|Drug|Placebo|10-week randomized, placebo controlled, double-blind, crossover trial, which includes a period of wash out of two weeks between treatment with dalfampridine and placebo.
16068778|NCT02391935|Drug|RCS-01|Cultured, autologous hair follicle cells suspended in cryomedium
16068779|NCT02391935|Drug|Placebo|Cryomedium
16068780|NCT02391935|Device|Sham injection|skin penetration of the needle without injection of liquid
16068781|NCT02391922|Behavioral|First aid course|
16068782|NCT02391922|Behavioral|First aid instructions by mobile phone|
16068783|NCT02391909|Biological|Vivotif|
16068784|NCT02391896|Device|Dual energy and tomosynthesis xray|
16068785|NCT02391883|Drug|Clopidogrel|
16068786|NCT02391870|Behavioral|MBCT-PD|Using an iterative process, the investigators modified MBCT to include a focus on perinatal depression (MBCT-PD). The modifications took into account developmental processes associated with the perinatal period, characteristics and correlates of perinatal depression, and the physical aspects of pregnancy.
16068787|NCT02391857|Procedure|Gastric decompression|Insertion the Naso(Oro)-gastric tube for early gastric decompression during CPR
16068788|NCT02391844|Drug|Oxycodone|Oxycodone with Acetaminophen Extended Release
16068789|NCT02391831|Other|Strength, function and activity measurements|
16068790|NCT02391831|Other|Muscle MRI|
16068791|NCT02391831|Other|Electrophysiology measurements|
16068792|NCT02391831|Other|Blood sampling for biomarker analysis|
16068793|NCT02391805|Drug|Entecavir|Entecavir will be administered as per local labeling.
16068794|NCT02391805|Drug|Placebo|Participants will be administered PO placebo capsules matched to RO6864018, either QOD or QWk for 12 weeks of treatment.
16068795|NCT02391805|Drug|RO6864018|Participants will be administered RO6864018 as 200-mg PO capsules at a dose of 800 mg or 1200 mg, either QOD or QWk for 12 weeks of treatment.
16068796|NCT02391805|Drug|Tenofovir|Tenofovir will be administered as per local labeling.
16068797|NCT02391779|Dietary Supplement|BeneFlax®|Daily ingestion of 600 mg SDG/day in 1.6 g SDG-enhanced flax lignan (BeneFlax®) with walking training or flexibility training
16068798|NCT02391779|Behavioral|Walking training|30-60 minutes walking training, 5 days/week.
16068799|NCT02391779|Behavioral|Flexibility training|5 days/week; e.g. stretching training at home
16068800|NCT02391779|Dietary Supplement|Placebo (Whey Protein)|0.6 g/day (an amount equal in volume to BeneFlax®) with walking training or flexibility training
16068801|NCT02391779|Behavioral|Dash Eating Plan|Dietary Approaches to Stop Hypertension (DASH), a balanced eating plan - all participants in all treatment arms will be encouraged to adopt a DASH eating plan.
16068802|NCT02391766|Behavioral|empowerment|"The groups of 10 participants meet once a week for eight weeks. last for four hours
~topics on dementia and prevention of further cognitive decline, active lifestyle and emotional well-being, spousal relationship, future planning kinds of active learning used are working in pairs and brainstorming sessions."
16068803|NCT02391766|Behavioral|usual care|
16068804|NCT02391753|Device|Transperineal 3D Ultrasound|Imaging was performed with women in lithotomy position with empty bladder. The probe was covered with a sterile film and placed on the perineum in the sagittal plane. The field of view angle was set to a maximum of 70° in the sagittal plane and the volume acquisition angle to 85° in the axial plane. Analysis of stored volumes was conducted offline by another experienced investigator blinded to clinical and delivery data.
16068805|NCT02391740|Other|Questionnaire|
16068806|NCT02391727|Biological|SYN004|subjects who have received effective treatment for their cancers are eligible
16068807|NCT02391714|Procedure|IUD insertion|The IUD (Mirena® or ParaGard®) insertion procedure will occur in the usual manner for both arms. A bimanual exam will be performed, the speculum placed and the cervix visualized. The cervix will then by cleaned with iodine solution. If you are allergic to iodine, we will use chlorhexidine instead. A tenaculum will be placed on the cervix and a uterine sound will be used to measure cavity length. The Mirena® or ParaGard® IUD will be inserted with the specific introducer.
16068808|NCT02391714|Drug|Povidone-Iodine|Povidone-Iodine 10% w/w antiseptic swab for the cervix prior to IUD insertion.
16068809|NCT02391714|Drug|Chlorhexidine|For patients with allergy to iodine - 2% w/v chlorhexidine gluconate and 70% v/v isopropyl alcohol antiseptic swab for the cervix prior to IUD insertion.
16068810|NCT02391714|Other|Oxygen|100% oxygen via nasal mask.
16068811|NCT02391714|Other|Nitrous oxide|Given in a fixed dose ratio of 50% nitrous oxide/50% oxygen via nasal mask.
16068812|NCT02391701|Behavioral|Diet|diet program 1 day a month for 3 months in 120-minute diet sessions + freely receive Atlantic Diet food (vegetables, cheese, olive oil, mussels and wine)
16068813|NCT02391688|Drug|Caffeine, omeprazole, flurbiprofen, dextromethorphan, midazolam|
16068814|NCT02391688|Drug|Bupropion|
16068815|NCT02391688|Drug|Fexofenadine|
16068816|NCT02391662|Drug|Nab-paclitaxel 125 mg/m2 weeks 1,2,3/4|Nab-paclitaxel 125 mg/m2 days 1,8 & 15 in a 28 days cycle
16068817|NCT02391662|Drug|Gemcitabine 1000 weeks 1,2,3/4|Gemcitabine 1000 days 1,8 & 15 in a 28 days cycle
16068818|NCT02391649|Behavioral|Self-learning program|The PSBBP in this study consists of 5 modules (Module 1: Caregiver's well-being; Module 2:Getting the best out of support services; Module 3:Well-being of the person with schizophrenia; Module 4:Dealing with the [psychosocial] effects of the illness; and Module 5:Dealing with [physical and mental health] effects of the illness), helping each caregiver from developing a positive attitude to caregiving, identifying caring related problems and obstacles, predicting positive and negative implications of each alternative, to trying out the solution and monitor if it worked.
16068819|NCT02391649|Behavioral|Psycho-education program (in Phase 2)|The program consists of 12 two-hour sessions held weekly/biweekly completed in 5 months, with 4 main components, including 'introduction and goal setting'; 'an education workshop on mental illness, treatment and community services'; 'group exercises/rehearsals and discussion on symptom management, coping and self-care'; and 'review and future plan'.
16068820|NCT02391636|Drug|Carbetocin|at delivery of anterior shoulder
16068821|NCT02391636|Drug|Oxytocin|at delivery of anterior shoulder
16068822|NCT02391623|Drug|PF-06427878|PF-06427878 will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=8).
16068823|NCT02391623|Drug|Placebo|Placebo will be administered as an extemporaneously prepared solution every 8 hours for 14 days (n=2).
16068824|NCT02391623|Drug|PF-06427878|PF-06427878 will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=8).
16068825|NCT02391623|Drug|Placebo|Placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days (n=2).
16068826|NCT02391610|Other|No intervention|
16068827|NCT02391584|Device|XprESS|Balloon dilation of the Eustachian tube
16068828|NCT02391584|Other|Control|Continued medical management
16068829|NCT02391571|Drug|Oxycodone/Naltrexone Capsules|Oxycodone/Naltrexone to be taken with stable dose of Methadone
16068830|NCT02391571|Drug|Oxycodone|Oxycodone to be taken with stable dose of Methadone
16068831|NCT02391571|Drug|Placebo|2 day placebo run in prior to test and active drug phase of study
16068832|NCT02391545|Drug|Duvelisib|PI3K Inhibitor
16068833|NCT02391545|Drug|Rituximab|monoclonal antibody
16068834|NCT02391545|Drug|Obinutuzumab|monoclonal antibody
16068835|NCT02391532|Dietary Supplement|L. reuteri DSM 17938/ATCC PTA|Ingestion of active lozenge twice daily for 12 weeks
16068836|NCT02391532|Dietary Supplement|Placebo|Ingestion of placebo lozenge twice daily for 12 weeks
16068837|NCT02391519|Procedure|Collection of myometrial, cord blood, and placental tissue samples|We propose to collect myometrial, cord blood, and placental tissue samples from women at high altitude (Summit County) and low altitude (Denver) in Colorado in order to determine if residence at altitude during pregnancy changes the vasoreactivity of myometrial arteries (MA).
16068838|NCT02391506|Device|Cartiva|Cartiva Synthetic Cartilage Implant
16068839|NCT02391493|Device|functional magnetic resonance imaging|"Stimuli will be presented in 3 language conditions, French, English and switch in which the participant alternates between English and French every trial. A block design will be used, with 7 line drawings per language condition. Four 9-minute runs will be performed, there being 2 action runs and 2 object runs. In each run, there are 6 blocks of each language condition, presented in a fixed random order. No drawings are repeated. Each stimulus is preceded either by an English or a French prompt word (to or faire for actions and, say or dire for objects) for 450 msec; stimuli are presented for 1.5 seconds and followed by a blank screen for 1 second. Language blocks are separated by a variable duration (from 8 to 10 seconds)."
16068840|NCT02391480|Drug|ABBV-075|ABBV-075 Oral tablets
16068841|NCT02391480|Drug|Venetoclax|Venetoclax tablets, film-coated
16068916|NCT02390921|Drug|Venofer|The patients will continue their usual endovenous administration of Venofer 300mg every 3 month
16068842|NCT02391454|Device|RunKeeper App|Group B will use the RunKeeper app for 12 weeks to self-monitor PA. In the scope of this study, patients merely have to self-monitor PA (e.g. swimming, biking, hiking, running) by GPS or stopwatch function with RunKeeper. Furthermore, patients are requested to activate the 'training reminder' option in the RunKeeper app, which is explained in the user's manual.
16068843|NCT02391454|Other|Usual care|
16068844|NCT02391428|Procedure|blood test|Blood test: Small volume (3 ml) of blood will be taken by venipuncture into ethylenediaminetetraacetic acid (EDTA) tube.
16068845|NCT02391428|Dietary Supplement|omega3 capsules|Only ADHD children will be given a supply of omega3 capsules (containing 400 mg EPA and 200 mg DHA)
16068846|NCT02391415|Biological|VPM1002|Tuberculosis vaccine
16068847|NCT02391415|Biological|BCG|commercially available live vaccine BCG
16068848|NCT02391415|Biological|VPM1002(Hyg+)|Tuberculosis vaccine
16068849|NCT02391402|Behavioral|Cognitively Augmented Behavioral Activation|CABA uses Behavioral Activation (BA) to identify meaningful goals and activities while learning cognitive skills to aid in working toward those goals. Early sessions of CABA focus on learning about mTBI, PTSD, and lifestyle skills that can improve thinking abilities and mood. Cognitive skills taught each week include internal and external skills to help manage problems with memory, attention, and regulation of thinking processes. Investigators and patients will spend a part of each session applying the cognitive skills to managing real life situations and getting patients active in the service of personal goals.
16068850|NCT02391402|Behavioral|Treatment as Usual|"TAU care involves psychotherapy (counseling) provided by a specialist in the treatment of PTSD. Patients will be offered individual appointments with an experienced provider on the PTSD Clinical Team (PCT). Beyond this, the specific approach will be determined by the patient and his/her provider and may include skills for managing PTSD and/or a chance for the patient to process his/her traumatic experiences. Additional treatments may be offered to patients, such as group classes and medications. TAU care may also include additional evaluation and/or treatment of mTBI, provided by the usual care offered in Portland or Seattle's respective neuropsychology clinics. Treatment for mTBI includes individual or group sessions, and is based on clinical need."
16068851|NCT02391389|Procedure|CPAP or PPV during DCC|CPAP or PPV is provided during delayed cord clamping
16068852|NCT02391376|Other|moist heat pack; ;|Three sessions of 15 minutes of superficial heat through a moist heat pack-MHP applied on the lower back.
16068853|NCT02391376|Other|seed pack|Three sessions of 15 minutes of superficial heat through a seed pack-SP applied on the lower back.
16068854|NCT02391376|Other|gel pack|Three sessions of 15 minutes of superficial heat through a gel pack-GP applied on the lower back.
16068855|NCT02391363|Behavioral|Cognitive behavior treatment|Anxiety management skills with the option to included religious/spiritual beliefs and practices
16068856|NCT02391363|Behavioral|Information and referral|Resource counseling and follow-up for mental health and basic needs
16068857|NCT02391350|Behavioral|Education and re-assurance|Patients are provided the Back Book and the contents are reviewed emphasizing the favorable natural history of back pain and sciatica and the importance of remaining active.
16068858|NCT02391350|Procedure|Physical Therapy|Physical therapy will consist of repeated exercises, spinal mobilization and mechanical traction in an effort to maximize centralization of symptoms.
16068859|NCT02391337|Drug|Bisoprolol|Drug intervention
16068860|NCT02391337|Drug|Digoxin|Drug intervention
16068861|NCT02391324|Procedure|Lokomat (LOK)|Physical therapy provided using a robotic gait training system (Lokomat).
16068862|NCT02391324|Procedure|Gait focused physical therapy (fPT)|Overground physical therapy focussed on enhancing gait related motor skills
16068863|NCT02391324|Procedure|LOK + fPT|A combination of robotic gait training and gait focussed functional physical therapy.
16068864|NCT02391311|Device|transcranial direct current stimulation (tDCS)|tDCS is a low level electrical stimulation that will be applied to F10. The sham group will receive 2 mA (milliamps) for 30 seconds, while the experimental group will receive 2 mA for 20 minutes. Both groups will have 10, 1 hour sessions of playing cognitive remediation games, while receiving the respective level of tDCS for sham vs experimental conditions.
16068865|NCT02391298|Behavioral|Mindfulness Meditation|
16068866|NCT02391285|Device|dynamometer (Auckland vaginal elastometer)|"The elastometer is a modified vaginal speculum which captures pelvic muscle tone over 3 minutes and records this on an attached computer. In addition to the elastometer test, there are three further related tests, which patients would be suitable to participate in.
~I. a questionnaire to fill in so as to obtain some feedback from patients regarding what they thought of the test and the device.
~II. The investigators would like to repeat the elastometer measurement within a week of the first test to determine the reliability and accuracy of repeating the measurement after a few days.
~III. The investigator would like to request that the patient have an MRI scan of the pelvic muscles to check whether the elastometer can pick up functional muscle weakness that would not otherwise be recognised except by performing an MRI scan. The investigators will therefore compare elastometer readings to the MRI scan findings."
16068867|NCT02391272|Drug|rhTPO|
16068868|NCT02391259|Drug|AMG 557|AMG 557 is for the treatment of sybjects with systemic lupus erythematosus
16068869|NCT02391259|Drug|Placebo|contains no active drug
16068870|NCT02391246|Other|Positron Emission Tomography Imaging|Participants will receive an intravenous injection of 250 MBq (megabecquerels) of 18F-Fluorodeoxyglucose (18F-FDG). The first Positron Emission Tomography (PET) acquisition of the head will occur one hour post-injection. The second acquisition will take place 3 hours post-injection. Both early and late PET images will be manually co-registered with the participant's most recent magnetic resonance images.
16068871|NCT02391233|Behavioral|E-WORTH|E-WORTH (Empowering African-American Women on the Road to Health) consists of 1 Streamlined HIV Testing session followed by 5 one-and-a-half hour group sessions that will be delivered by a probation provider at the probation site. The main multimedia components used in the E-WORTH: (1) Narrativity; (2) Skill acquisition using simulated video vignettes that provides instruction and demonstration of core skills (e.g., safer sex negotiation and problem-solving skills, technical condom use skills) using culturally congruent role models; (3) Individual interactive exercises and logs that are designed to enhance participant's recall of core knowledge and tracking of their individual progress in reducing risky behaviors and achieving risk reduction goals; and a (4) Facilitator interactive guide.
16069000|NCT02390375|Drug|DW-0929|5/10mg
16068872|NCT02391233|Behavioral|Streamlined HIV Testing|In this intervention Black Women on Probation receive streamlined HIV Testing alone to test primary outcomes of decreasing biologically confirmed STIs and the number and proportion of unprotected sexual acts among Black Drug-involved women on probation.
16068873|NCT02391220|Other|LCA symbiotic fermented milk|LCA symbiotic fermented milk with the probiotic cultures Lactobacillus acidophilus La-5® and Bifidobacterium animalis ssp. lactis BB-12® and the Beneo dietary fibers.
16068874|NCT02391220|Other|heat-treated fermented milk|heat-treated fermented milk without probiotic cultures and dietary fibres
16068875|NCT02391207|Procedure|Hepatic vein-sparing hepatectomy|HV detachment, partial resection and section on the basis of HV-CLM relationship
16068876|NCT02391194|Drug|AVB-620|
16068877|NCT02391181|Drug|Iron Sucrose Azad|Test product Iron Sucrose Azad will be administered intravenously via a 18 gauge (18G) needle. For intravenous injection, a 5 mL single dose of test product (each mL containing 20 mg/mL elemental iron as iron sucrose in water for injection) will be diluted in 0.9% isotonic sterile sodium chloride (NaCl) up to 15 mL. The injection solution will be intravenously administered to the forearm vein, resulting in a total injection volume of 15 mL administered over a period of 5 minutes.
16068878|NCT02391181|Drug|Venofer®|Reference product Venofer® will be administered intravenously via a 18 gauge (18G) needle. For intravenous injection, a 5 mL single dose of reference product (each mL containing 20 mg/mL elemental iron as iron sucrose in water for injection) will be diluted in 0.9% isotonic sterile sodium chloride (NaCl) up to 15 mL. The injection solution will be intravenously administered to the forearm vein, resulting in a total injection volume of 15 mL administered over a period of 5 minutes.
16068879|NCT02391155|Procedure|single lumen needle in oocyte retrieval|single lumen needle use during oocyte retrieval
16068880|NCT02391155|Procedure|double lumen needle in oocyte retrieval|after aspiration of follicles, 3 times flushing will be performed in double lumen needle.
16068881|NCT02391142|Drug|Lidocaine|0.5% lidocaine 5ml epidural injection every 2 hours per day or 0.2% ropivacaine 5ml epidural injection every 4 hours per day, last for 4weeks
16068882|NCT02391129|Procedure|Operation for Periprosthetic fractures of the hip with stem loosening|
16068883|NCT02391116|Drug|Copanlisib (Aliqopa, BAY80-6946)|Participants assigned to receive copanlisib intravenous (IV) infusion at a dose of 60 mg as single agent on Days 1, 8, and 15 of 28-day treatment cycle. Copanlisib treatment was to be continued until disease progression (PD), unacceptable toxicity, or until another criterion was met for withdrawal from the study treatment
16068884|NCT02391103|Device|Compex 3 Professional (CefarCompex Medical AB) stimulator|NMES
16068885|NCT02391103|Device|sham-stimulation|no electricity applied
16068886|NCT02391090|Device|hypoxia in hypoxic chamber|Intervention lasts 4 hours per day for 6 days in a row.
16068887|NCT02391090|Device|sham hypoxia in hypoxic chamber|Intervention lasts 4 hours per day for 6 days in a row.
16068888|NCT02391090|Procedure|Pulse oximetry|Pulse oximetry will be performed hourly during sessions in the hypoxic chamber for safety reasons.
16068889|NCT02391090|Other|Asthma and Quality of Life Questionnaires|Before every session in the hypoxic chamber as well as on the day after the last session will be completed.
16068890|NCT02391090|Procedure|Lung function testing|On the day of the first session in the hypoxic chamber as well as on the day after the last session lung function testing will be performed.
16068891|NCT02391090|Procedure|Blood taking|On the day of the first session in the hypoxic chamber as well as on the day after the last session blood samples will be taken.
16068892|NCT02391090|Procedure|FeNO measurement|Before every session in the hypoxic chamber as well as on the day after the last session FeNO (forced exhaled nitric oxide) measurement will be performed.
16068893|NCT02391077|Other|Povidone-Iodine|Foreskin disinfection with Povidone-Iodine
16068894|NCT02391077|Other|Antibiotic topical cream|Application of 1gr of Antibiotic topical cream / ointment onto the exposed inner foreskin up to the coronal sulcus
16068895|NCT02391077|Other|Chlorhexidine 1%|Daily washes with Chlorhexidine 1% (2-3 times a day), for 6 days
16068896|NCT02391064|Behavioral|Cognitive evaluation|"Questionnaires for assessment of confounding factors
~Cognitive evaluation
~Walking tests and 9 Hole Peg Test"
16068897|NCT02391064|Behavioral|Expanded Disability Status Scale (EDSS) score|- EDSS score
16068898|NCT02391051|Radiation|HDR-Brachytherapy|HDR-Brachytherapy 2x 13,5 Gy
16068899|NCT02391038|Drug|MLN0264|MLN0264 IV.
16068900|NCT02391025|Drug|Gallium-68 citrate PET|Injection of Gallium-68 citrate followed by PET imaging
16068901|NCT02391025|Procedure|Positron Emission Tomography (PET)|
16068902|NCT02391012|Biological|Fecal microbial l transplantation|infusion of preparation of fecal preparation from a healthy donor to a colitis patient
16068903|NCT02390999|Procedure|48 hours of therapeutic hypothermia|
16068904|NCT02390986|Drug|LON002|Extension study to provide continuing access to LON002 medication.
16068905|NCT02390973|Procedure|Sleeve Gastrectomy|
16068906|NCT02390973|Procedure|Roux-en-Y Gastric Bypass|
16068907|NCT02390973|Procedure|Biliopancreatic Diversion with Duodenal Switch|
16068908|NCT02390973|Other|Medical management|
16068909|NCT02390960|Drug|Sildenafil Cream|Patients will be instructed to apply pre-weighed SST-6006 to the non-erect penile skin area at the time of dosing. Patients will then massage the cream into the penile shaft and glans for a maximum of 3 minutes.
16068910|NCT02390960|Drug|Placebo Cream|Patients will be instructed to apply the pre-weighed placebo cream to the non-erect penile skin area at the time of dosing. Patients will then massage the cream into the penile shaft and glans for a maximum of 3 minutes.
16068911|NCT02390960|Device|Penile Plethysmography (RigiScan)|During each dosing period, penile plethysmography will be utilized to evaluate efficacy of SST-6006 verses placebo cream. Each plethysmography session will be approximately 75 minutes.This includes a 15 minute 'baseline' period where patients are told to remain in the flaccid state and 60 minutes during which time patients will watch a series of erotic videos.
16068912|NCT02390947|Drug|Famitinib|25 mg p.o. qd
16068913|NCT02390947|Drug|Placebo|25 mg p.o. qd
16068914|NCT02390934|Radiation|Radium 223|
16068915|NCT02390921|Drug|Fisiogen Ferro Forte|The patients will interrupt the endovenous treatment with iron and will receive liposomated iron 28mg/daily during 3 months.
16069001|NCT02390375|Drug|DW-0929|10/10mg
16068917|NCT02390908|Behavioral|Immediate PLUS intervention|The Positive Living through Understanding and Support (PLUS) intervention consists of six sessions that utilizes motivational interviewing and cognitive behavioral skills training to reduce alcohol use and improve medication adherence.
16068918|NCT02390908|Behavioral|Wait-list PLUS intervention|In addition to treatment as usual, participants will receive handouts with printed information about HIV, the importance of ART adherence, and problematic alcohol use and HIV disease progression. Following their assessment 12 months after their baseline visit, participants will receive the PLUS intervention.
16068919|NCT02390895|Procedure|endoscopic repair of myelomeningocele before 26 SA|prenatal minimally-invasive fetoscopic closure with iii) uterine exteriorization for a minimally-invasive repair under amniotic carbon dioxide insufflation iv) two trocars for the dissection and the cover with one patch or the suture of the skin edges by stitch
16068920|NCT02390882|Drug|Placebo|Placebo
16068921|NCT02390882|Drug|HGP0412 capsule|Tamsulon high dose
16068922|NCT02390882|Drug|HIP1402 capsule|Tamsulon high dose
16068923|NCT02390869|Drug|R2-MANT|A) Rituximab 375 mg/sqm on day 1 every 90 days for 8 cycles B) Lenalidomide (10 mg daily on days 1-21 every 28 days) for 24 cycles
16068924|NCT02390869|Drug|R-MANT|A) Rituximab 375 mg/sqm on day 1 every 90 days for 8 cycles
16068925|NCT02390856|Device|Conventus DRS|The Conventus DRS (TM) is an intramedullary device intended to treat distal radius fractures. The device remains flexible during placement, but is made rigid at the completion of the surgical implant procedure. The implant is made from titanium alloy (Ti-6A1-4V) and Nitinol.
16068926|NCT02390856|Device|Volar Plate|A volar plate is a metallic plate fastened directly to the fractured bone with screws, to hold the fracture fragments in proper position. Volar plate fixation is the traditional surgical method for distal radius fractures.
16068927|NCT02390843|Drug|Simvastatin|The starting dose of simvastatin will be 140 mg/m^2/dose BID for 21 days for the first group. Dose escalation for subsequent groups will be 180 mg/m^2/dose BID, 225 mg/m^2/dose BID, and 290 mg/m^2/dose BID. If the maximum tolerated dose (MTD) has been exceeded at the first dose level, then the subsequent cohort of subjects will be treated at a dose of 100 mg/m2/dose BID (dose level 0). Simvastatin will be administered orally twice daily, approximately 12 hours apart. Feeding tube (nasogastric tube or gastrostomy tube, NOT a jejunum localized tube) administration is allowed. If a subject vomits a dose of simvastatin, it will not be repeated.
16068928|NCT02390843|Drug|Cyclophosphamide|The dose of cyclophosphamide will be fixed at 250 mg/m^2/dose. Cyclophosphamide will be administered intravenously over 30 minutes once daily for 5 days every 21 days.
16068929|NCT02390843|Drug|Topotecan|The dose of topotecan will be fixed at 0.75 mg/m^2/dose. Topotecan will be administered, after cyclophosphamide, intravenously over 30 minutes once daily for 5 days every 21 days.
16068930|NCT02390843|Drug|Myeloid growth factor|Myeloid growth factor (G-CSF or pegylated G-CSF) will be initiated 24-48 hours after the completion of topotecan and cyclophosphamide for all subjects, which would be day 6 or 7. Myeloid growth factor should continue until the absolute neutrophil count is greater than 2,000/mm^3
16068931|NCT02390830|Other|Falls Prevention|
16068932|NCT02390830|Other|Reduction of limitations at body function and activity levels|
16068933|NCT02390817|Drug|Sugammadex|Administration of Sugammadex
16068934|NCT02390817|Drug|Neostigmine|Administration of Neostigmine
16068935|NCT02390804|Device|single-port laparoscopic hysterectomy(single port trochar)|perform laparoscopic hysterectomy via single-port access
16068936|NCT02390804|Device|multi-port laparoscopic hysterectomy(multi port trochar)|perform laparoscopic hysterectomy via multi-port access
16068937|NCT02390791|Other|enhanced myADHDportal.com|Version of the myADHDportal.com web software enhanced with family-management support to enable parents to be active partners in optimizing and maintaining medication continuity for their child
16068938|NCT02390791|Other|treatment as usual standard portal|Standard version of myADHDportal.com web software
16068939|NCT02390778|Behavioral|Group Debriefing|Group Debriefing involves story-telling, identifying emotional responses to these stories, psycho-education and practical information to normalize group member reactions to a distressing event.
16068940|NCT02390778|Behavioral|leisure activity (film showing)|
16068942|NCT02390739|Drug|Aldesleukin|Aldeskeukin 720,000 IU/kg IV over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 3 days (maximum of 9 doses).
16068943|NCT02390739|Drug|Fludarabine|Day -7 to -3:Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
16068944|NCT02390739|Drug|Cyclophosphamide|Days -7 and -6:Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W over 1 hour.
16068945|NCT02390739|Biological|Anti-Thyroglobulin mTCR PBL|On day 0, one to four days after last dose of fludarabine, cells will be infused intravenously (IV) over 20 to 30 minutes.
16068946|NCT02390726|Biological|Fecal Microbiota Transplant|
16068947|NCT02390726|Biological|Placebo|
16068948|NCT02390713|Device|MID-AVR|"Phase A (4 patients): After laparotomy and dissection of hepatic pedicle, feasibility of MID-AVR positioning around the portal vein by hepato-biliary surgeon and visual evaluation of potential spatial conflict with hepatic artery and choledochal. Mid-AVR is removed at the end of surgery. Each procedure will be filmed.
~Phase B (12 patients): Mid-AVR is maintained at the end of surgery, and during 48 hours to evaluate the persistence of an hepatopetal portal flow without portal vein thrombosis upstream MID-AVR during the 48 hours after the liver surgery at bi-daily ultrasonography."
16068949|NCT02390700|Biological|Golimumab Intravenous|This is a non-interventional study. Participants with rheumatoid arthritis in Canada will be observed for 24 months.
16068950|NCT02390687|Drug|Probiotic|Each probiotic lozenge contains not less than 1 billion colony forming unit of Lactobacillus brevis CD2
16068951|NCT02390687|Drug|Placebo|Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)
16068952|NCT02390674|Drug|Ciclosporin|Comparison between ciclosporin and placebo
16068953|NCT02390674|Drug|Saline|
16068954|NCT02390661|Device|Penrose drain placement|A penrose drain will be placed in the lumpectomy cavity after removal of the irradiation catheter
16068955|NCT02390648|Drug|Ginger|Ginger capsule (500 mg) taking twice a day by mouth during the first 5 days of chemotherapy cycle
16069002|NCT02390375|Drug|DW-0929|20/10mg
16068956|NCT02390648|Drug|Placebo|Placebo capsule taking twice a day by mouth during the first 5 days of chemotherapy cycle
16068957|NCT02390635|Procedure|Computed Tomography|Undergo 18F-FDG PET/CT
16068958|NCT02390635|Procedure|Diffusion Weighted Imaging|Undergo whole body PET/MRI
16068959|NCT02390635|Radiation|Fludeoxyglucose F-18|Undergo 18F-FDG PET/CT
16068960|NCT02390635|Drug|Gadolinium|Given IV
16068961|NCT02390635|Procedure|Magnetic Resonance Imaging|Undergo whole body PET/MRI
16068962|NCT02390635|Procedure|Positron Emission Tomography|Undergo 18F-FDG PET/CT and whole body PET/MRI
16068963|NCT02390635|Procedure|Three-Dimensional Spoiled Gradient MRI|Undergo whole body PET/MRI
16068964|NCT02390622|Other|Fecal microbiota transplantation|bacteria liquid from 60g fecal was infusion via nasointestinal tube for three days
16068965|NCT02390609|Drug|Ibrutinib (Treatment A) [Reference]|Participants will receive Ibrutinib 560 milligram (mg) (4*140 mg) capsule as Treatment A under fasted conditions in one of the treatment periods.
16068966|NCT02390609|Drug|Ibrutinib (Treatment B)|Participants will receive Ibrutinib 560 mg suspension as Treatment B under fasted conditions in one of the treatment periods.
16068967|NCT02390609|Drug|Ibrutinib (Treatment C)|Participants will receive Ibrutinib 560 mg suspension as Treatment C under fed (high-fat) conditions in one of the treatment periods.
16068968|NCT02390609|Drug|Ibrutinib (Treatment D)|Participants will receive Ibrutinib 560 mg sprinkle capsule granules as Treatment D under fasted conditions in one of the treatment periods.
16068969|NCT02390609|Drug|Ibrutinib (Treatment E)|Participants will receive Ibrutinib 560 mg sprinkle capsule granules as Treatment E under fed (high-fat) conditions in one of the treatment periods.
16068970|NCT02390609|Drug|Ibrutinib (Treatment F)|Participants will receive Ibrutinib 560 mg sprinkle capsule granules suspended in water as Treatment F under fasted conditions in one of the treatment periods.
16068971|NCT02390596|Drug|Anakinra|The dose of Anakinra will be 2mg/kg (patients <10kg and/or <8 months: 4mg/kg). If the patient remains febrile (fever >38°C), he will receive a double dose of anakinra 4mg/kg (patients <10kg and/or <8 months: 6mg/kg) at day1 instead of 2mg/kg. If the patient does not respond to the 4mg/kg dose at visit 3; d1 within 24 hours, he will receive at visit 4; d2, 6mg/kg of anakinra (patients <10kg and/or <8 months: 8mg/kg). Treatment will be continued until they have achieved complete response as defined in the outcome measurement section, and during a maximum of 15 days.
16068972|NCT02390583|Behavioral|CBT treatment of internet dependence|CBT treatment of internet dependence
16068973|NCT02390583|Behavioral|CBT treatment of sleep disorders|CBT treatment of sleep disorders
16068974|NCT02390570|Other|Patient Capacity Assessment Instrument|The Patient Capacity Assessment instrument is a conversational tool designed to help patients and clinicians discuss capacity in clinicial conversations of primary care.
16068975|NCT02390557|Other|Survey|PDQS survey reports only
16068976|NCT02390557|Other|YESHealth|Arm 3: YESHealth and PDQS survey reports to providers
16068977|NCT02390544|Drug|Melphalan|Melphalan is a bifunctional alkylating agent that inhibits DNA and RNA synthesis, cross-links strands of DNA and acts on both resting and rapidly dividing cells including tumor cells. It is administered intravenously.
16068980|NCT02390505|Drug|Vitamin C|
16068981|NCT02390505|Drug|Placebo|
16068982|NCT02390492|Drug|Period 1 treatment|200 mg oral ipatasertib followed 1 hour later by 80-mcg/800-nCi intravenous [14C]-ipatasertib on Day 1 of study
16068983|NCT02390492|Drug|Period 2 treatment|200-mg/100-mcCi oral [14C]-ipatasertib on Day 15 of study
16068984|NCT02390479|Other|non surgical periodontal treatment|"SRP under local anaesthesia, in a total of four clinical visits
~Oral hygiene instructions including the modified Bass technique, regular toothpaste, and an appropriate interdental cleaning device with dental floss and interdental brush."
16068985|NCT02390466|Biological|VAC-3S|Administered via intra-muscular injection in the arm
16068986|NCT02390453|Behavioral|Combined Cognitive and Physical|Combined modules provide Cognitive training from Posit Science designed to improve information processing speed, learning, memory, and attention, and Physical training focused on seated aerobic and progressive resistance exercises designed to improve aerobic capacity, muscular strength, and endurance consistent with current exercise recommendations for older adults.
16068987|NCT02390453|Behavioral|Cognitive|Cognitive modules from Posit Science are designed to improve information processing speed, learning, memory, and attention.
16068988|NCT02390453|Behavioral|Physical|Physical modules are focused on seated aerobic and progressive resistance training designed to improve aerobic capacity, muscular strength, and endurance consistent with current exercise recommendations for older adults.
16068989|NCT02390453|Behavioral|Control|Control modules provide social contact for group discussion and instruction in health self-management and successful aging.
16068990|NCT02390440|Drug|EXPAREL|
16068991|NCT02390427|Drug|Taselisib|
16068992|NCT02390427|Drug|Trastuzumab emtansine|
16068993|NCT02390427|Drug|Pertuzumab|
16068994|NCT02390427|Drug|Trastuzumab|
16068995|NCT02390427|Drug|Paclitaxel|
16068996|NCT02390401|Device|Vacuum-assisted closure|Prevena (VAC) device at the time of primary closure for a cesarean section, left in place for 5-7 days postoperatively.
16068997|NCT02390401|Device|Standard sterile dressing|Standard sterile dressing at the time of primary closure for a cesarean section, left in place for 1-2 days postoperatively.
16068998|NCT02390388|Procedure|pudendal nerve block|nerve stimulator-guided Pudendal block
16068999|NCT02390388|Procedure|caudal block|caudal block
16069004|NCT02390375|Drug|Rosuvastatin|10mg F/U study: DW-0929 10/10mg
16069005|NCT02390375|Drug|Rosuvastatin|20mg F/U study: DW-0929 20/10mg
16069006|NCT02390362|Drug|Rituximab|We hypothesize that the anti-CD20 monoclonal antibody Rituximab will be more effective in maintaining remission in children who have already had one relapse while receiving MMF
16069007|NCT02390362|Drug|MMF|Subjects randomized to MMF, will continue MMF as scheduled by the investigator
16069008|NCT02390349|Other|Placebo|
16069009|NCT02390349|Dietary Supplement|Curamin|
16069010|NCT02390349|Dietary Supplement|CuraMed|
16069011|NCT02390336|Other|Real mobilization-with-movement (MWM)|For the MWM group, the investigator applied two techniques of mobilization with movement: one for flexion and one for medial rotation of the hip. With the hip in flexion, a stabilizing belt was placed on the medial side of the participant's thigh closest to the joint interline. The belt was placed around the pelvic region of the physical therapist, keeping a perpendicular direction to the participant's thigh. Maintaining a side slip, it was carried out a passive movement of 1) hip flexion (3x10) and 2) medial hip rotation (3x10) by the physiotherapist throughout painless amplitude.
16069012|NCT02390336|Other|Sham mobilization-with-movement (MWM)|In the sham group, the investigators conducted a technical simulation. The positioning of the patient and the physical therapist was the same, however, no accessory mobilization was performed with the help of the belt and did not performed repeated movements of passive flexion or medial rotation.
16069013|NCT02390323|Procedure|Lumbar Sympathetic Block|"A lumbar sympathetic block is an injection in the middle of the lower back, toward the left or right side. The lumbar sympathetic nerves are a small bundle of nerves that carries sympathetic nerve signals from the lower extremities. In some instances, certain injuries to the lower extremities can cause a burning, unusual pain called complex regional pain syndrome or reflex sympathetic dystrophy. Injecting a small amount of local anesthetic on the lumbar sympathetic nerves can identify whether or not this pain is carried by the sympathetic nervous system."
16069014|NCT02390323|Device|Skin conductance algesimeter|The real-time changes in skin conductance indices can be monitored at the skin level, by use of non-invasive electrodes attached to the skin (similar to EKG electrodes) connected to the skin conductance algesimeter. A computer program analyzes the data and produces a real-time graphic and numeric data demonstrating the skin conductance response. The initiation of successful sympathetic blockade can cause rapid cessation of the skin sympathetic activity that leads to a decrease in skin conductance within seconds.
16069015|NCT02390310|Device|Shang Ring|Comparison of healing times at 7 day and more than 7 days after circumcision.
16069016|NCT02390310|Drug|injectable anesthesia (lidocaine 1%)|Comparison of Anesthesia methods for Shang Ring circumcision. Comparison of pain during Shang Ring circumcision when using injectable vs. topical anesthesia.
16069017|NCT02390310|Drug|topical anesthesia (lidocaine 2.5%, prilocaine 2.5% cream)|Comparison of Anesthesia methods for Shang Ring circumcision. Comparison of pain during Shang Ring circumcision when using injectable vs. topical anesthesia.
16069018|NCT02390297|Genetic|Blood tests|Collection of blood samples for general health (complete blood count) and Cal-1 specific analyses
16069019|NCT02390284|Drug|Latanoprost|Lower intraocular pressure (IOP) by increasing outflow of fluid from the eye.
16069020|NCT02390284|Drug|Bimatoprost|Lower intraocular pressure by increasing outflow of fluid from the eye.
16069021|NCT02390284|Drug|Travoprost|Lower intraocular pressure by increasing outflow of fluid from the eye.
16069022|NCT02390284|Drug|Timolol|Lower intraocular pressure by decreasing production of fluid
16069023|NCT02390284|Drug|Dorzolamide|Lowers intraocular pressure by decreasing intraocular fluid production
16069024|NCT02390284|Drug|Brinzolamide|Lowers intraocular pressure by decreasing intraocular fluid production
16069025|NCT02390284|Drug|Acetazolamide|Lowers intraocular pressure by decreasing intraocular fluid production
16069026|NCT02390284|Drug|Methazolamide|Lowers intraocular pressure by decreasing intraocular fluid production
16069027|NCT02390271|Other|emotion focused therapy training|The Cardiac Coherence Training (CCT) incorporates a series of emotion-refocusing and restructuring techniques involving the use of biofeedback to control heart rate variability
16069028|NCT02390258|Drug|10mg XEN-D0103|
16069029|NCT02390258|Drug|Placebo|
16069030|NCT02390258|Drug|30mg XEN-D0103|
16069031|NCT02390258|Drug|60mg XEN-D0103|
16069032|NCT02390258|Drug|120mg XEN-D0103|
16069033|NCT02390258|Drug|200mg XEN-D0103|
16069034|NCT02390258|Drug|150mg XEN-D0103|
16069035|NCT02390245|Other|Use of patient navigation and social worker|This arm will include phoning patients to schedule appointments; confirming appointments by mailings, emails and/or text messaging; arranging transportation through Customized Community Transportation (CCT) and Philadelphia Paratransit Service; and scheduling trained medical interpreters.
16069036|NCT02390232|Biological|liver biopsy|A small needle is inserted into the liver to collect a tissue sample
16069037|NCT02390232|Biological|collection of stools|collection of stools
16069038|NCT02390232|Biological|blood sample|collection of blood sample
16069039|NCT02390219|Drug|Lumacaftor|
16069040|NCT02390219|Drug|Ivacaftor|
16069041|NCT02390193|Procedure|Hemodialysis|"Daytime haemodialysis was standardised. It was performed 3 times per week, with a 4-h session duration, 250-mL/min blood flow, and 500-mL/min dialysate flow, using bicarbonate buffered dialysate with 1.25 mmol/L ionised calcium concentration, dialysate temperature of 36.5°C.
~The ultrafiltration amount for each haemodialysis session was decided by individual dry weight, which was fixed during the trial. In addition, the patients were not permitted to change their medication or start new drugs, especially antiplatelet agents, angiotensin-converting enzyme inhibitors, angiotensin II receptor antagonists, calcium-channel blockers, and β-blockers.
~The patients who required a change in medication for medical reasons were subsequently excluded from the study."
16069042|NCT02390180|Other|Tasting solutions|Participants will taste a variety of food grade compounds including: hexenoic acid, decenoic acid, oleic acid, linoleic acid, glucose, fructose, salt, citric acid, acetic acid, quinine, urea, caffeine, sucrose octaacetate, propylthiouracil, phenylthiocarbamide, monosodium glutamate, and inosine monophosphate.
16069079|NCT02389894|Device|CardioGard Cannula|CardioGard Cannula, per the manufacturer's instructions for use (IFU).
16069080|NCT02389881|Drug|TAK-058|TAK-058 Solution
16069043|NCT02390167|Device|ONYX NEXT BGMS|Untrained Persons WITH Diabetes Use the ONYX NEXT BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX NEXT BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested venous blood from subjects WITH Diabetes and BG results were compared to reference method results obtained from the subjects' venous plasma.
16069044|NCT02390154|Drug|roniciclib (BAY 1000394)|Single dose , 2.5 mg roniciclib spiked with 5.0 MBq of [14C] roniciclib solution
16069045|NCT02390154|Drug|roniciclib (BAY 1000394)|5 mg roniciclib tablet , Multiple dose, twice a day (bid), on a 3-days on/4-days off regimen in cycles of 21 days
16069046|NCT02390141|Drug|ZP4207|
16069047|NCT02390141|Drug|Placebo|
16069048|NCT02390128|Other|observational only|
16069049|NCT02390115|Other|Elastic tape application in shoulder|
16069050|NCT02390102|Drug|Erythropoietin|Combinaison drug of darboepoetin 0.75µg/Kg + 200mg intravenous iron sucrose
16069051|NCT02390102|Drug|Placebo|Saline solution 0.9%
16069052|NCT02390089|Drug|Capsaicin vapor|Single-breath and continuous inhalation paradigm to induce cough.
16069053|NCT02390089|Other|fog|Continuous inhalation of fog until a cough is produced, or up to 60 seconds (whichever is shortest)
16069054|NCT02390089|Radiation|Videofluoroscopic swallow evaluation|Fluoroscopic evaluation of oropharyngeal swallowing function.
16069055|NCT02390089|Device|Nebulizer|A hand-held nebulizer will be used to aerosolize the capsaicin and water solutions. Participants will inhale through the device's mouthpiece, and cough if they need to.
16069056|NCT02390076|Device|Left Low Level Light Therapy|Administration of left LLLT consists of applying light of a specific wavelength (1064 nanometers) using a laser diode, the CG-5000 high density laser (Cell Gen Therapeutics, LLC). Left LLLT will target the left forehead. The diameter parameters of stimulation are the same that showed psychologically beneficial effects in Schiffer et al. (2009). At the power level described, the energy emitted by the CG-5000 at this setting is one quarter of the skin MPE (0.250 W/cm2), exposure to it is not deemed harmful to tissue, and it causes no detectable physical damage and negligible heat.
16069057|NCT02390076|Other|Attention bias modification|The task will consist of a modified dot-probe paradigm. A pair of stimuli depicting a negative word and a neutral word will be presented, randomly located to the right and left side of the computer screen. The words will be presented for 1000 ms. The words will then disappear and a dot-probe will appear in the center of the screen location of one of the words (i.e., O or Q). This probe will appear on the screen until the participant presses one of two response buttons to indicate the identity of the probe. The presentation of the probe will be staggered to maximize attention for the neutral stimulus. Latency and accuracy of the button press responses are recorded by the computer.
16069058|NCT02390076|Device|Right Low Level Light Therapy|Administration of right LLLT consists of applying light of a specific wavelength (1064 nanometers) using a laser diode, the CG-5000 high density laser (Cell Gen Therapeutics, LLC). Right LLLT will target the right forehead. The diameter parameters of stimulation are the same that showed psychologically beneficial effects in Schiffer et al. (2009). At the power level described, the energy emitted by the CG-5000 at this setting is one quarter of the skin MPE (0.250 W/cm2), exposure to it is not deemed harmful to tissue, and it causes no detectable physical damage and negligible heat.
16069059|NCT02390076|Device|Sham Low Level Light Therapy|Administration of sham LLLT is designed to resemble active LLLT from the participant's perspective, but uses a dosage markedly below the minimal necessary threshold to elicit a response.
16069060|NCT02390063|Biological|ChAdOx1.5T4|A recombinant simian adenovirus encoding human tumour-associated antigen 5T4
16069061|NCT02390063|Biological|MVA.5T4|A recombinant replication deficient Modified Vaccinia Ankara virus encoding human tumour-associated antigen 5T4
16069062|NCT02390063|Drug|Cyclophosphamide|Metronomic cyclophosphamide (50mg bd)
16069063|NCT02390050|Drug|Bexagliflozin tablets|Bexagliflozin tablets are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.
16069064|NCT02390050|Drug|Bexagliflozin tablets, placebo|Bexagliflozin tablets, placebo, are blue caplet-shaped, film-coated tablets that are intended for use in investigational studies in humans.
16069065|NCT02390024|Device|Invasive Mechanical Ventilation|"Mechanical ventilation parameters will be monitorized during the ICU stay in all patients Four types of ventilators will be used:
~Servo Dräger Evita XL Dräger Evita 4 Puritan Bennet 840"
16069066|NCT02390011|Procedure|MRI|
16069067|NCT02389998|Other|Placebo Suspension|The study is divided into three phases: 1 one-week baseline assessment followed by 2 three-week study phases (phase A and phase B). Phase A will require subjects to take 1/4 teaspoon placebo suspension 2 times a day (morning and night), and a third dose if necessary. In phase B subjects will not take the placebo. After 3 weeks in initial phase (either Phase A or B), subjects will switch to the alternate phase and continue the study for another 3 weeks. Hyoscyamine is available as a rescue medication during Phase A and Phase B. Half of the subjects will be randomized to begin with Phase A and half will be randomized to begin with Phase B.
16069068|NCT02389998|Drug|Hyoscyamine|While not an intervention of interest to our study, patients will have hyoscyamine available as a rescue medication throughout the study. This can be taken on a PRN basis for breakthrough pain a maximum of 4x daily.
16069069|NCT02389985|Drug|CRLX101|
16069070|NCT02389985|Drug|Paclitaxel|
16069071|NCT02389972|Drug|Dasatinib|
16069072|NCT02389959|Drug|Bevacizumab|Bevacizumab will be mixed by the Stanford Hospital Pharmacy to a total dose of 100mg in 4mL, and 50mg (2mL) will be injected into each side of the nose
16069073|NCT02389959|Drug|Placebo (Saline)|4mL of saline will be mixed by the Stanford Hospital Pharmacy as a control
16069074|NCT02389946|Device|Orsiro DES|Orsiro is a device/drug combination product composed of two components, a device (coronary stent system including a cobalt chromium stent platform), and a drug product (a formulation of sirolimus) contained in a bioabsorbable polymer coating.
16069075|NCT02389946|Device|Xience DES|
16069076|NCT02389933|Drug|LCZ696|immediate release film coated tablet in 50 mg, 100 mg, 200 mg, and 400 mg strengths for oral administration.
16069077|NCT02389920|Drug|Nilotinib|
16069078|NCT02389894|Device|Embol-X Embolic Protection Device|per the manufacturer's instructions for use (IFU).
16069081|NCT02389881|Drug|TAK-058 Placebo|TAK-058 placebo-matching solution
16069083|NCT02389855|Procedure|NeuroBlate® System Therapy|
16069084|NCT02389842|Drug|Palbociclib + Taselisib / Pictilisib|
16069085|NCT02389829|Drug|Hydromorphone|
16069086|NCT02389829|Drug|Prochlorperazine|
16069087|NCT02389829|Drug|Diphenhydramine|
16069088|NCT02389816|Drug|Placebo|Placebo tablets
16069089|NCT02389816|Drug|Vortioxetine|Vortioxetine tablets
16069090|NCT02389803|Dietary Supplement|Nutritional supplementation standardized formula|Powder added to water, containing about 25% of recommended DRI for Calories, high protein (25% of calories) and multi vitamin and mineral (25%-100% of DRI for recommended daily allowance (RDA) or adequate intake )
16069091|NCT02389803|Dietary Supplement|Placebo comparator|Low caloric formula (Powder added to water), without added vitamins and minerals
16069092|NCT02389790|Drug|MT-1303|
16069093|NCT02389777|Biological|ST266 immediate|ST266 will be applied immediately to the UV light burn wound topically by spray twice per day
16069094|NCT02389777|Biological|ST266 delayed|ST266 will be applied to the UV light burn topically by spray twice per day beginning 6-12 hours after the burn
16069095|NCT02389764|Drug|BIBF 1120|Initial dose is 200 mg twice daily orally for a 28 day cycle.
16069096|NCT02389764|Behavioral|Phone Call|Participant called by a member of the study staff every 3 months for up to 1 year after end-of-treatment visit. These calls should last about 2 minutes.
16069097|NCT02389751|Drug|Carboplatin|Given IV
16069098|NCT02389751|Drug|Ganetespib|Given IV
16069099|NCT02389751|Drug|Paclitaxel|Given IV
16069100|NCT02389751|Radiation|Radiation Therapy|Undergo radiation therapy
16069101|NCT02389738|Drug|Regadenoson|Regadenoson administration on post-op day 2 after temozolomide administration. Temozolomide plasma and dialysate concentrations will be obtained over 18 hours post temozolomde administration.
16069102|NCT02389738|Drug|Temozolomide|Temozolomide administration on post-op day 1 and 2. Temozolomide plasma and dialysate concentrations will be obtained over 18 hours post temozolomde administration.
16069103|NCT02389738|Device|Microdialysis catheter|Microdialysis catheter placement post surgical resection and removed at the bedside after completion of obtaining all dialysate collections.
16069104|NCT02389725|Device|disposable elastic tourniquet|Comparison of first time peripheral IV access success rate between the standard elastic tourniquet and a blood pressure cuff.
16069105|NCT02389725|Device|blood pressure cuff|Comparison of first time peripheral IV access success rate between the standard elastic tourniquet and a blood pressure cuff.
16069106|NCT02389712|Drug|Lamotrigine|Lamotrigine dosing: 25 mg daily x 2 weeks, 50 mg daily x 2 weeks, 100 mg daily x 2 weeks, 200 mg (100 mg bid)) x 4 weeks. If patient still has at least mild depressive symptoms, the dose can be increased to 300 mg daily for 2 weeks and 400 mg for 4 weeks. Dose will be held for treatment response and can be reduced for side effects.
16069107|NCT02389712|Drug|Fluoxetine|Fluoxetine dosing: 20mg for month 1, 40mg for month 2, and if still depressed (CGI ≥ 3) 60mg for month 3 and 4. Lower doses of fluoxetine will be prescribed for those with side effects. For known Cytochrome P450 2D6 poor metabolizers, fluoxetine will not be dosed > 40mg.
16069108|NCT02389699|Radiation|Intraoperative Radiotherapy|Boost with 20 Gy during BCS, EBRT with 46-50 Gy
16069109|NCT02389699|Radiation|Whole breast radiation|whole breast radiation after BCS with 46-50 Gy
16069110|NCT02389686|Device|INTRABEAM (Carl Zeiss, Oberkochen, Germany)|Boost with 16 Gy during NSM for nipple-areola complex (NAC)
16069111|NCT02389673|Device|Intraoperative Radiotherapy|Boost with 20 Gy during BCS, EBRT with 46-50 Gy
16069112|NCT02389660|Behavioral|Blended Cognitive Behavioural Therapy (CBT)|
16069113|NCT02389660|Behavioral|Treatment as usual|
16069114|NCT02389621|Drug|Lusutrombopag|Tablets for oral administration
16069115|NCT02389621|Drug|Placebo|Tablets for oral administration
16069116|NCT02389608|Device|Transcranial direct current stimulation (tDCS)|The active tDCS and placebo will be applied to the primary motor cortex (M1) and FES active and placebo will be applied to the anterior tibial muscle (TA).
16069117|NCT02389608|Device|Functional electrical stimulation (FES)|
16069118|NCT02389608|Device|Sham stimulation|
16069119|NCT02389595|Other|HIV positive subjects|This group will provide a blood sample.
16069120|NCT02389595|Other|Non-infected control subjects|This group will be de-identified blood samples from a commercial source.
16069121|NCT02389582|Drug|Dabigatran|Use for 5 days
16069122|NCT02389582|Drug|Enoxaparin|Use for 5 days
16069123|NCT02389569|Procedure|Adhesive system|Etch-and-rinse and Self-etch adhesive system will be applied in volunteers that received different types of restoration protocol.
16069124|NCT02389569|Procedure|Restoration protocol|Volunteers will be treated by two types of protocol restoration : 1) Biosilicate (powder) or 2) Control (without Biosilicate). In sequence, adhesive (self-etch or etch and rinse) and composite resin will be used for restoration.
16069125|NCT02389543|Drug|Selinexor|Two different dosing schedules will be tested, once weekly and twice weekly. If the selinexor 80 mg dose is tolerated, the dose will be increased to 100 mg.
16069126|NCT02389543|Drug|Lenalidomide|In both arms, lenalidomide will be started at 15 mg/day (Dose Level 1) and, if tolerated per DLT criteria, will be escalated to 25 mg/day (Dose Level 2).
16069127|NCT02389543|Drug|Dexamethasone|"Dexamethasone will be given in combination with each dose of selinexor on the once weekly treatment arm.
~For the twice weekly arm dexamethasone will be given in combination with each dose of selinexor and will also be given without selinexor on Days 22 and 24."
16069128|NCT02389530|Drug|Fluorescein|Fluorescein will be administered intravenously at a dose between 250 mg and 400 mg in the experimental arm.
16069129|NCT02389517|Drug|Ixazomib Citrate|Given PO
16069130|NCT02389517|Drug|Lenalidomide|Given PO
16069131|NCT02389517|Drug|Dexamethasone|Given PO
16069132|NCT02389504|Other|Dynamic Exertional Physical Therapy|By contrast, the dynamic exertion protocol includes the treadmill running aspect, but also incorporates other exercises that involve lateral movement (e.g., side lunges, lateral speed training exercises) as well as planar changes (e.g., burpees, squat thrusts) . Recovery on these exercises is measured based on time subjects are able to tolerate the exertion without symptom increase. Across all exertion protocols additional measures of subjective physical effort and objective measurement of heart rate are taken.
16069133|NCT02389504|Other|Standard Exertional Physical Therapy|Standard treadmill running, monitoring heart rate
16069134|NCT02389491|Dietary Supplement|normal density formula (Necocate)|In control group,there are 32 infants
16069135|NCT02389491|Dietary Supplement|high density formula(Infatrini)|In intervention group,there are 32 infants
16069136|NCT02389478|Procedure|Oropharyngeal administration of colostrums|rubbing drops of colostrum inside a baby's cheeks using a sterile syringe
16069137|NCT02389478|Procedure|Oropharyngeal administration of Normal saline|rubbing drops of Normal saline inside a baby's cheeks using a sterile syringe
16069138|NCT02389465|Drug|Escitalopram + Celecoxib|Participants will receive celecoxib in addition to escitalopram
16069139|NCT02389465|Drug|Escitalopram + Placebo|Participants will receive a placebo in addition to escitalopram.
16069140|NCT02389452|Drug|Synvisc-One|intraarticular injection
16069141|NCT02389439|Drug|Pyronaridine-artesunate|
16069142|NCT02389426|Device|TCD baseline|"Measurement of cerebral circulation parameters with transcranial doppler baseline.
~This examination will be performed in patients with multiple sclerosis and in healthy controls."
16069143|NCT02389426|Device|TCD after bosentan administration|"Measurement of cerebral circulation parameters with transcranial doppler after administration of one tablet tracleer (Bosentan) 62,5 mg per oral.
~This examination will only be performed in patients with multiple sclerosis."
16069144|NCT02389426|Device|NIRS baseline|"Measurement of frontal lobe oxygen saturation with near-infrared spectroscopy baseline.
~This examination will be performed in patients with multiple sclerosis and in healthy controls."
16069145|NCT02389426|Device|NIRS after bosentan administration|"Measurement of frontal lobe oxygen saturation with near-infrared spectroscopy after administration of one tablet tracleer (Bosentan) 62,5 mg per oral.
~This examination will only be performed in patients with multiple sclerosis."
16069146|NCT02389413|Drug|PQ912 oral|
16069147|NCT02389413|Other|Placebo|
16069148|NCT02389400|Drug|methotrexate|Single Group Assignment
16069149|NCT02389387|Other|Intensive Intervention|I.A multi-module, secure, web-enabled software application called Transplant Referral EXchange (T-REX):1) real-time communication between staff across healthcare settings, documenting the use of transplant education materials, 2) sending/receiving electronic referrals for transplant specific to a transplant center's requirements and 3) tracking patients' status in the transplant process (e.g., patient interest in transplant, referral for transplant, evaluation start/completion, waitlist status, and transplant) II. Educational webinars/seminars for staff, III. Facility-specific performance feedback reports, IV. Assistance with and review of center-specific action plans to increase transplant referral, V. Scheduled bi-annual phone calls with an SETC member to monitor progress, VI. Patient education on transplant via creation of an Education Station in facility lobby, VII. Development of a Peer Mentor program.
16069150|NCT02389374|Drug|chloroquine|standard dose
16069151|NCT02389374|Drug|Artemether-lumefantrine combination|standard dose
16069152|NCT02389374|Drug|Primaquine|single dose
16069153|NCT02389374|Drug|Primaquine|14 days
16069154|NCT02389361|Drug|Zaldiar|Postoperative analgesia with oral Zaldiar (combination of tramadol and paracetamol)
16069155|NCT02389361|Drug|Paracetamol-Tramadol|Postoperative analgesia with intravenous Paracetamol and Tramadol
16069156|NCT02389348|Drug|DSM265|Single oral doses of DSM265
16069157|NCT02389348|Drug|OZ439|Single oral doses of OZ439
16069158|NCT02389322|Biological|5μg/ml ESAT6-CFP10|The participants are injection intradermally with 0.1 ml 5μg/ml ESAT6-CFP10 12 weeks after BCG immunization or placebo immunization.This biological diagnostic reagents is injection agent .Every subject apply for the 5μg/mlRecombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 only one time after choosing into study population II .
16069159|NCT02389322|Biological|10μg/ml ESAT6-CFP10|The participants are injection intradermally with 0.1 ml 10μg/ml ESAT6-CFP10 12 weeks after BCG immunization or placebo immunization.This biological diagnostic reagents is injection agent .Every subject apply for the 10μg/mlRecombinant Mycobacterium Tuberculosis Allergen ESAT6-CFP10 only one time after choosing into study population II .
16069160|NCT02389322|Biological|BCG|The participants are injected intradermally with 0.1 ml BCG.This BCG is Freeze-dried agent and with five people dose of each bottle,so each bottle of BCG must dissolve by 0.5ml special diluent before administration.Every subject apply for the BCG vaccine only one time after choosing into study population II .
16069161|NCT02389322|Biological|placebo|The participants are injected intradermally with 0.1 ml placebo of Bacillus Calmette-Guerin.This placebo is Freeze-dried agent and with five people dose of each bottle ,so each bottle must dissolve by 0.5ml special diluent before administration.Every subject apply for the BCG vaccine only one time after choosing into study population II .
16069162|NCT02389309|Drug|Cyclophosphamide|Given PO
16069163|NCT02389309|Drug|Dasatinib|Given PO
16069164|NCT02389309|Other|Laboratory Biomarker Analysis|Correlative studies
16069165|NCT02389309|Drug|Temsirolimus|Given IV
16069166|NCT02389296|Other|Questionnaire|Questionnaires will be distributed to nursing staff
16069167|NCT02389257|Device|MINIMAG / MEG|
16069168|NCT02389257|Device|MINIMAG / ECG|
16069169|NCT02389244|Drug|Regorafenib|For adults patients and children with BSA ≥1.70 m² : 4 tablets once daily until progression or unacceptable toxicity For children with BSA ≥1.30 and ≤1.69 m² : 3 tablets once daily until progression or unacceptable toxicity
16069170|NCT02389244|Drug|Placebo|For adults patients and children with BSA ≥1.70 m² : 4 tablets once daily and switch to regorafenib after confirmed progression For children with BSA ≥1.30 and ≤1.69 m² : 3 tablets once daily and switch to regorafenib after confirmed progression
16069171|NCT02389231|Drug|Interleukine-2|"Four courses of IL2 ( [Proleukin, Novartis]) will be administered subcutaneously for 5 days.
~The first course will be limited to a dose of 1.5 million IU per day and followed by a 9 day wash-out.
~The other courses of 3 million IU per day will be initiated after a 16 day wash-out."
16069172|NCT02389218|Device|single ablation (CryoBalloonAblation (CBA)|Cryoablation at entry, after randomization to this group
16069173|NCT02389218|Drug|sequential drug adjustment (propafenone, sotalol or flecainide)|Correct drug dosage at entry, sequential adjustment / titration, in stage 2 amiodarone
16069204|NCT02388945|Other|CAPD|CAPD used in the PD Patients for 8 weeks
16069205|NCT02388932|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
16069174|NCT02389205|Other|kinesio group|"kinesio group, The kinesio Taping® Method is a definitive rehabilitative taping technique that is designed to facilitate the body's natural healing process while providing support and stability to muscles and joints without restricting the body's range of motion as well as providing extended soft tissue manipulation to prolong the benefits of manual therapy administered within the clinical setting.
~The effect of intervention may affected by the varying durations and frequencies of exercise, different state of arthropathy and joint range of motion limitations of ankle , etc."
16069175|NCT02389192|Drug|ZMAPP|ZMappTM, a combination of three mouse/human chimeric monoclonal antibodies (mAbs; c4G6, c2G4, and c13C6-FR1) directed against Ebola virus glycoprotein epitopes
16069176|NCT02389179|Drug|Vitamin D3|The drug/dosage of Vitamin D3 will be given monthly or bi-weekly depending on the type of arm that the subjects are randomised into under direct supervision.
16069177|NCT02389166|Device|Optiflow|"Patients receive high flow oxygen delivery system, Optiflow, conventional clinical management and sequential used of NIV for a period of 36 hours at least.
~High flow oxygen nasal therapy (Optiflow) : The flow will be set at 40l/min to 60l/min The inspired fraction of oxygen (FiO2) is the same as that defined at the end of VNI session and may be adjusted in order to obtain a SaO2 between 94% and 98%."
16069178|NCT02389166|Device|Conventional oxygen therapy|Patients receive conventional oxygen therapy with high concentration mask, conventional clinical management, and sequential use of NIV Conventional oxygen therapy: The inspired fraction of oxygen (FiO2) is the same as that defined at the end of VNI session and may be adjusted in order to obtain a Arterial Oxygen Saturation (SaO2) between 94% and 98%.
16069179|NCT02389153|Behavioral|collaborative care CHD|Over a time span of 6 months participants receive individualized treatment to reduce risk factors and improve quality of life, based on their preferences following a health plan, which they developed with their health coach.
16069180|NCT02389140|Other|Trigger point release|Trigger point therapy
16069181|NCT02389140|Other|Ultrasound|sham ultrasound
16069182|NCT02389127|Device|Continuous glucose monitor (Dexcom, San Diego, CA)|(Group B) patients with known diabetes and cirrhosis with varying degrees of liver dysfunction will wear a continuous glucose monitor (Dexcom, San Diego, CA) for 2 continuous days during week days and week ends, every 4 weeks for 12 consecutive weeks.
16069183|NCT02389114|Other|Soy Protein|Soy protein is commonly consumed in Asian diet.
16069184|NCT02389114|Other|Polydextrose|Polydextrose is a randomly bonded polymer of glucose developed in the 1960s. It is widely recognized as a soluble fiber that is not digested in the upper gastrointestinal tract due to the complex structure and nature of the glycosidic bonds, but is partially fermented by the microbiota in large intestine generating short chain fatty acids.
16069185|NCT02389101|Other|68Ga-DOTANOC PET/CT; Diffusion weighted MRI|PET/CT: Radionuclide imaging using short-lived isotope Ga-68; MRI imaging w/o gadolinium contrast
16069186|NCT02389088|Drug|Letrozole|In Phase II, letrozole, 5 mg/day, will be given for 14 days
16069189|NCT02389062|Other|Administration of gluten( food /wheat protein) capsules or placebo(cornstarch) capsules and tests for novel markers will be done at intervals.|After administering the capsules for 16 weeks during study periods, patients's blood will be tested for novel markers- Intestinal fatty acid binding protein(I-FABP), stool for gluten intestinal peptide (GIP), urine for gluten intestinal peptide(GIP), patient estimated gluten intake(PEGI), celiac severity index(CSI), Celiac dietary adherence test(CDAT) by standard questionnaire provided during the visits. These tests will be done over a period of 16 weeks and at a follow up 3 months later.
16069190|NCT02389036|Drug|SDD Oral Paste|A six-hourly topical application of 0.5g paste, containing colistin 10mg, tobramycin 10mg and nystatin 125,000 IU, to the buccal mucosa and oropharynx
16069191|NCT02389036|Drug|SDD Gastric Suspension|2. A six-hourly administration of 10 mL of a suspension containing 100 mg colistin, 80 mg tobramycin and 2 x 10 ^6 IU nystatin, to the gastrointestinal tract via a gastric/post-pyloric tube
16069192|NCT02389036|Drug|Intravenous Antibiotic|A four-day course of an intravenous antibiotic in patients not already receiving a therapeutic antibiotic
16069193|NCT02389023|Other|standard gauze dressing|Standard gauze dressing with tape will be placed over the surgical incision in the operating room and left on the incision as dictated by standard of care
16069194|NCT02389023|Other|Prevena Incision Management system|The Prevena dressing system over the closed surgical incision. The dressing consists of a sterile sponge that is placed over the incision followed by a plastic adhesive covering that is used to secure it to the skin forming an air-tight seal. The sponge is then connected by tubing to a vacuum that applies negative pressure to the closed system. This allows fluid to drain from the wound and into a container connected to the dressing.
16069195|NCT02389010|Biological|Allogeneic cord blood platelet gel-CBPG|For the medication of patients, one CBPG unit (mean volume 10 mL, range 5-15; mean platelet concentration 1 x 109/L, range 0.8 - 1.2 x 109/L. 10 mL in plasma) will be administered every 3-4 days. CBPG units, cryopreserved and stored in a plastic bag in a -80°C freezer, will be thawed at 37°C in a waterbath and activated with Calcium gluconate and immediately transported to sites of clinical use and applied to the skin ulcer without breaking the sterility chain.
16069196|NCT02389010|Other|Standard Local Medications-SLM|Each clinical center will use their validated standard local medications. Details and specifications of the local standard medication procedures will be collected from each participating centre.
16069197|NCT02388997|Drug|omalizumab|This medication has been approved for clinical use to treat patients with moderate to severe asthma by the FDA in 2003 and for use in this study (BB-IND# 10510)
16069198|NCT02388997|Biological|Rhinovirus (strain 16)|This strain of pooled rhinovirus has been approved for use in experimental challenges (BB-IND# 15162) and for use in this study (BB-IND# 10510) by the FDA.
16069199|NCT02388984|Drug|Compound danshen dripping pills|Dosage form:pill. Dosage:20pills. Frequency:three times per day. Duration:24 weeks.
16069200|NCT02388984|Drug|Placebo|Dosage form:pill. Dosage:20pills. Frequency:three times per day. Duration:24 weeks.
16069201|NCT02388971|Drug|MLN1202|MLN1202 solution
16069202|NCT02388971|Drug|Placebo|MLN1202 placebo-matching solution
16069203|NCT02388945|Other|APD|PDGO APD machines used in the PD patients for 8 weeks
16069206|NCT02388932|Device|Positron Emission Tomography|Undergo PET/CT
16069207|NCT02388932|Device|Computed Tomography|Undergo PET/CT
16069208|NCT02388932|Other|Quality-of-Life Assessment|Ancillary studies
16069209|NCT02388919|Drug|Anlotinib|Basic dosage, take once when limosis in the morning. If patients cannot suffer from AEs, they can get declined dosage.
16069210|NCT02388919|Drug|Placebo|Basic dosage, take once when limosis in the morning.
16069211|NCT02388906|Drug|Ipilimumab|Specified dose on specified days
16069212|NCT02388906|Drug|Nivolumab|Specified dose on specified days
16069213|NCT02388906|Other|Placebo matching Ipilimumab|Specified dose on specified days
16069214|NCT02388906|Other|Placebo matching Nivolumab|Specified dose on specified days
16069215|NCT02388880|Device|ITPR|Single use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the periods of positive pressure ventilations.
16069216|NCT02388867|Procedure|Polytetrafluoroethylene (PTFE) bypass grafting.|Polytetrafluoroethylene (PTFE) bypass grafting. Patients will undergo bypass procedure using PTFE graft : the inflow vessel may be the femoral artery or the iliac artery; the outflow vessel may be the popliteal artery or the anterior tibial artery.
16069217|NCT02388867|Procedure|Autogenous vein bypass grafting|Autogenous vein bypass grafting. Patients will undergo Bypass procedure using autogenous veins (the great saphenous vein or the small saphenous vein or a composite bypass using great and small saphenous vein ). The inflow vessel may be represented by the femoral artery or the popliteal artery; the outflow vessel may be the anterior tibial artery or the posterior tibial artery or the peroneal artery.
16069218|NCT02388854|Genetic|SNPs analysis with Sanger sequencing|Research of frequency of SNPs (WNT4, VEZT, FSHB and SIRT1 genes) in Sardinian women affected by endometriosis and controls
16069219|NCT02388841|Radiation|Pulmonary embolism|the thrombus were assessed with Computed tomographic pulmonary angiography
16069220|NCT02388828|Biological|lentiviral-based CART meso therapy|
16069221|NCT02388815|Device|FreeStyle Libre Flash Glucose Monitoring System|"Subjects will wear the Abbott Sensor Based Glucose Monitoring System masked for 14 days.
~During these 14 days subjects will be asked to perform 4 blood glucose tests (meals time and before bedtime) per day. At the same time as the blood glucose test a sensor scan is performed."
16069222|NCT02388802|Procedure|Oocyte retrieval and freezing|10 Patients will undergo oocyte retrieval and freezing
16069223|NCT02388802|Procedure|Deceased Donor Allograft Excision|Appropriately matched uterine transplant allografts will be excised from deceased donors
16069224|NCT02388802|Procedure|Uterine Transplantation|Following egg freezing the patients will undergo uterine transplant from deceased donors
16069225|NCT02388802|Drug|Immunosuppressive Agents|Patients will be appropriately immunosuppressed, whilst being closely monitored clinically, radiologically and immunologically.
16069226|NCT02388802|Procedure|In-vitro fertilisation|12 months after successful transplantation,the patients will undergo IVF
16069227|NCT02388802|Procedure|Caesarean Section|Following successful conception and antenatal period, the babies will be born by Caesarean Section
16069228|NCT02388789|Other|active movement|same as arm description
16069229|NCT02388776|Device|ROTEM|A blood sample and reagents are placed into a small cup. A pin suspended from a wire is immersed into the sample. The pin rotates back and forth at a fixed angle. The movement of the pin is optically monitored and converted into a real time measurement that is represented graphically. Prior to clot formation, pin rotation is unhindered and is graphically represented as a straight line. As the subject's blood sample starts to clot, strands of clot form between the pin and the cup wall, restricting the movement of the pin depending on the strength of the clot. Graphically, this is represented as a symmetrical widening of the curve.
16069230|NCT02388763|Device|Stenfilcon A contact lenses|Contact lenses worn during Period 1 or 2, as randomized
16069231|NCT02388763|Device|Narafilcon A contact lenses|Contact lenses worn during Period 1 or 2, as randomized
16069232|NCT02388750|Drug|Palonosetron|Palonosetron 0.5 mg every other day until completion of radiation and at least one hour prior on days of RT
16069233|NCT02388750|Radiation|Low or moderate risk radiotherapy|Low or moderately emetogenic radiotherapy will be given to all patients on study.
16069234|NCT02388737|Drug|Vonoprazan|Vonoprazan tablets
16069235|NCT02388737|Drug|Lansoprazole|Lansoprazole capsules or tablets
16069236|NCT02388737|Drug|Vonoprazan Placebo|Vonoprazan placebo-matching tablets
16069237|NCT02388737|Drug|Lansoprazole Placebo|Lansoprazole placebo-matching capsules
16069238|NCT02388724|Drug|Vonoprazan|Vonoprazan tablets
16069239|NCT02388724|Drug|Lansoprazole|Lansoprazole capsules
16069240|NCT02388724|Drug|Vonoprazan Placebo|Vonoprazan placebo-matching tablets
16069241|NCT02388724|Drug|Lansoprazole Placebo|Lansoprazole placebo-matching capsules
16069242|NCT02388711|Other|C-TraC Intervention|C-TraC utilizes a nurse case manager to coordinate the patient's transitional care through active participation in inpatient multidisciplinary discharge rounds, a single brief protocol-driven inpatient encounter, and 1-4 protocol-driven post-hospital telephone calls with the patient/caregiver using spaced retrieval techniques.
16069243|NCT02388698|Procedure|Cervical swab|"Cervical Swab at baseline.
~HPV testing at recurrence, if applicable."
16069244|NCT02388698|Radiation|PET-CT|PET-CT will be completed 3 month post chemoradiation.
16069245|NCT02388698|Biological|Plasma HPV|Plasma HPV will be drawn at baseline, post radiation, 3 month post chemoradiation and at progression (if necessary).
16069246|NCT02388685|Other|Exercise|Home exercise therapy
16069247|NCT02388672|Dietary Supplement|decaffeinated coffee|Decaffeinated coffee with low chlorogenic acid (224mg; low-CGA)
16069248|NCT02388672|Dietary Supplement|chlorogenic acid|Decaffeinated coffee with high chlorogenic acid (560mg; high-CGA)
16069249|NCT02388672|Dietary Supplement|green coffee bean extract supplement|Decaffeinated coffee together with green coffee bean extract supplement (560mg; high-CGA)
16069250|NCT02388672|Dietary Supplement|placebo|Decaffeinated coffee with placebo capsules as control group for green coffee bean extract supplement (224mg; low-CGA)
16069251|NCT02388659|Device|3 Tesla scanning|Approximately 38 brain tumor patients with IDH mutated gliomas and 50 patients with non-glioma disease will be scanned.
16069252|NCT02388646|Other|Exercise Only|This group will be given a set of 2 exercises to complete at home. The exercises are designed to strengthen the quadriceps muscle group.
16069253|NCT02388646|Device|Brace Only|This group will be fitted with a Reaction Web brace and asked to wear it when going about activities of daily living.
16069254|NCT02388646|Other|Bracing + Exercises|This group will be asked to both wear the Reaction Web brace during activities of daily living and complete a set of 2 exercises designed to strengthen the quadriceps muscle group.
16069255|NCT02388633|Procedure|Plasmapharesis|Clinically-indicated LDL apheresis
16069256|NCT02388620|Drug|LEE011|400 mg
16069257|NCT02388607|Other|measurements|performance measurements
16069258|NCT02388594|Drug|ZFN Modified CD4+ T Cells|
16069259|NCT02388594|Drug|Cyclophosphamide|
16069260|NCT02388581|Drug|Lansoprazole, Amoxicillin, Clarithromycin, Metronidazole|Anti-H. pylori Therapy
16069261|NCT02388568|Drug|Lorcaserin|Lorcaserin plus Lifestyle Modification
16069262|NCT02388568|Drug|Placebo|Placebo plus Lifestyle Modification
16069263|NCT02388555|Procedure|Posterior osteotomy correction|The DLS patients underwent osteotomy including pedicle subtraction osteotomy (PSO) or Smith-Petersen osteotomy (SPO)
16069264|NCT02388542|Behavioral|Educational Intervention|Employees above the age of 35 years will be risk stratified into moderate or high risk of developing cardiovascular disease using a simple non-lab based risk scoring system, they will be invited to participate in the pilot intervention study. This is a single arm before-after study.subject education will focus on life style medication and adherence to medication (if applicable).importantly the peer mentor will try to identify barriers to adopting a healthy lifestyle(tobacco, physical acitivity, diet, alcohol and strees) and adherence to cardiovascular disease prevention medication. peer mentors will be trained to interpret blood glucose and lipids, recognize abnormal valves, provide lifestyle counseling and refer to treating physician when appropriate.
16069265|NCT02388529|Drug|MTP-131|MTP-131 (low dose) administered as once-daily 1- hour intravenous infusion for 5 consecutive days
16069266|NCT02388529|Drug|MTP-131|MTP-131 (intermediate dose) administered as once-daily 1- hour intravenous infusion for 5 consecutive days
16069267|NCT02388529|Drug|MTP-131|MTP-131 (high dose) administered as once-daily 1- hour intravenous infusion for 5 consecutive days
16069268|NCT02388529|Drug|Placebo|Placebo Comparator (at each dose cohort) administered as once-daily 1- hour intravenous infusion for 5 consecutive days
16069269|NCT02388516|Dietary Supplement|Vitamin D3|
16069270|NCT02388516|Dietary Supplement|Placebo|
16069271|NCT02388503|Dietary Supplement|no added fruit extract|
16069272|NCT02388503|Dietary Supplement|fruit extract|
16069273|NCT02388503|Dietary Supplement|fruit extract|
16069274|NCT02388503|Dietary Supplement|fruit extract|
16069275|NCT02388503|Dietary Supplement|fruit extract|
16069276|NCT02388490|Drug|brentuximab vedotin|Brentuximab vedotin administered by IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle. The dose of brentuximab vedotin is 1.8 mg/kg q 3 weeks.
16069277|NCT02388477|Drug|Doxycycline|antibiotic used to treat infection
16069278|NCT02388477|Drug|sugar pill|placebo with no pharmacologic effect
16069279|NCT02388464|Drug|MTP-131|MTP-131 (low dose) administered as single intravenous infusion over 4 hours
16069280|NCT02388464|Drug|MTP-131|MTP-131 (intermediate dose) administered as single intravenous infusion over 4 hours
16069281|NCT02388464|Drug|MTP-131|MTP-131 (high dose) administered as single intravenous infusion over 4 hours
16069282|NCT02388464|Drug|Placebo|Placebo Comparator (at each dose cohort) administered as single intravenous infusion over 4 hours
16069283|NCT02388451|Device|Feuerstein Program|The IE activity is administered by instructors in groups of 10 to 15 participants. The intervention comprises 30 twice weekly meetings of 90 minutes duration per group.
16069284|NCT02388438|Device|Bongener|
16069285|NCT02388399|Procedure|Device|Optical coherence tomography to evaluate plaque morphology and vulnerable features (ex> cap thickness, spotty calcification)
16069286|NCT02388399|Procedure|Device|Resting and hyperemic pressure pullback tracing will be done with motorized pullback system.
16069287|NCT02388386|Device|PROTEUS-SENSOR|An edible sensor system, Proteus Digital™ has been developed for electronically confirming medication adherence, gathering physiologic metrics and communicating these data to patients. The system consists of two major components: an edible sensor and a wearable receiver health monitor. An electrical signal is activated upon ingestion of the Proteus Digital micro-sensor with transmission of this signal to a receiving abdominal patch to quantify medication compliance.
16069288|NCT02388373|Drug|Fluticasone 250/formoterol 10|
16069289|NCT02388373|Drug|Fluticasone 250/salmeterol 25|
16069290|NCT02388373|Drug|Fluticasone 125/formoterol 5|
16069291|NCT02388360|Drug|topical prostaglandin analogs|
16069292|NCT02388347|Drug|Placebo SC|Participants will receive a single-dose of Placebo subcutaneous (SC) injection on Day 1.
16069293|NCT02388347|Biological|MEDI7836 Dose 1|Participants will receive a single-dose of MEDI7836 Dose 1 SC injection on Day 1.
16069294|NCT02388347|Biological|MEDI7836 Dose 2|Participants will receive a single-dose of MEDI7836 Dose 2 SC injection on Day 1.
16069295|NCT02388347|Biological|MEDI7836 Dose 3|Participants will receive a single-dose of MEDI7836 Dose 3 SC injection on Day 1.
16069296|NCT02388347|Biological|MEDI7836 Dose 4|Participants will receive a single-dose of MEDI7836 Dose 4 SC injection on Day 1.
16069297|NCT02388334|Other|to develop a standardized questionnaire|"to develop, from the caregivers' point of view, a standardized questionnaire evaluating 1) their quality of life (QOL) as related to the disease of the assisted and 2) their expectations concerning the global quality of professional management (care, coordination, information...).
~The development of this standardized tool will also :
~identify the specific support needs of the caregivers
~study the links between the quality of care as perceived by the professionals, patients and caregivers
~identify the characteristics of the caregivers (status) and patients (disease type, disease-modifying drug (DMD) initiation, disease duration) associated with questionnaire results."
16069298|NCT02388321|Drug|Ketamine|intranasal sub-dissociative dose ketamine for the treatment of moderate to severe pain in pediatric patients in the emergency department.
16069702|NCT02385227|Other|Exclusive blu™ e-cigarette A1|Classic Tobacco rechargeable e cigarette
16069299|NCT02388321|Drug|Fentanyl|intranasal fentanyl for the treatment of moderate to severe pain in pediatric patients in the emergency department.
16069300|NCT02388308|Device|Clarity ultrasound|Ultrasound imaging data will be recorded only. Treatment will not be altered as a result of this study.
16069301|NCT02388295|Drug|AZD3241|Drug: AZD3241 administered for 12 weeks orally as a tablet.
16069302|NCT02388295|Drug|Placebo|Placebo to match AZD3241 administered for 12 weeks orally as a tablet.
16069303|NCT02388282|Device|diaphragm ecography|recording of diaphragm ecography
16069304|NCT02388269|Device|gammaCore®-G|The gammaCore®-G device is a reusable, hand-held, portable device consisting of two 3.0 VDC batteries (not replaceable or user serviceable), signal generating and amplifying electronics, and two buttons for operator control of the signal amplitude. The device provides visible (light display) and audible feedback on device and stimulation status
16069305|NCT02388256|Device|acupuncture|"Points of Stomach 36 (ST36), Stomach 37 (ST37), Liver 3 (LR3), Large Intestine 11 (LI11), Large Intestine 4 (LI4), Spleen 6 (SP6), Spleen 4 (SP4) and Pericardium 6 (PC6) will be used. Electrical stimulation with alternating frequency of 2 to 100 Hz will be applied to the selected points (LI4 to LI11, ST36 to ST37, and bilateral SP6).
~Rationale of acupuncture treatments will include both traditional theory of harmonizing gastrointestinal function and strengthening vital energy as well as modern experimental and clinical evidence of regulating gastrointestinal motility and other symptom managements. Treatments will be provided by qualified hospital staff (Korean medical doctors) with more than 10 years of clinical experience."
16069306|NCT02388256|Other|early recovery program after surgery|An enhanced recovery program after surgery that was designed and is currently implemented by surgeons, anesthetists, dietitians, and nurses will be provided. The program includes preoperative education, early water/food intake, early mobilization, early removal of Foley catheter and drains, structured nursing care, and nutritional support.
16069307|NCT02388243|Behavioral|Brief Intervention in Public Clinic|The ASSIST-linked brief intervention includes a discussion, between the clinician and patient, of problem drinking and its associated adverse effects and how to address risky level of alcohol use, using motivational interviewing techniques, assess and manage any complication or co-morbidity uncovered, and request to the patient to follow-up in one month. Clinicians will also be asked to record their baseline and follow-up clinical assessment and management through clinical follow-up forms. The total brief intervention should be around 15 minutes, with a follow-up visit of about the same length a month later. This intervention in happening in a public clinic.
16069308|NCT02388243|Behavioral|Screening Results in Public Clinic|At each public clinic, a community health worker will ask patients presenting for consultation who are aged 18 years or older to be screened for healthy lifestyle and to receive feedback on their results. The screening will include self-reported weight and height, (for BMI calculation), level of physical activity, and the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). The inclusion of the BMI and level of physical activity is to mask the purpose of the intervention, by decreasing the focus on substance use. The community health worker will provide the results of the BMI, physical activity and the ASSIST and will offer a leaflet with further explanation about how to address problems with those lifestyles
16069309|NCT02388243|Behavioral|Brief Intervention in Private Clinic|The ASSIST-linked brief intervention includes a discussion, between the clinician and patient, of problem drinking and its associated adverse effects and how to address risky level of alcohol use, using motivational interviewing technics, assess and manage any complication or co-morbidity uncovered, and request to the patient to follow-up in one month. Clinicians will also be asked to record their baseline and follow-up clinical assessment and management through clinical follow-up forms. The total brief intervention should be around 15 minutes, with a follow-up visit of about the same length a month later. This intervention in happening in a private clinic.
16069310|NCT02388243|Behavioral|Screening Results in Private Clinic|At each private clinic, a support staff will ask patients presenting for consultation who are aged 18 years or older to be screened for healthy lifestyle and to receive feedback on their results. The screening will include self-reported weight and height, (for BMI calculation), level of physical activity, and the Alcohol, Smoking and Substance Involvement Screening Test (ASSIST). The inclusion of the BMI and level of physical activity is to mask the purpose of the intervention, by decreasing the focus on substance use. The support staff will provide the results of the BMI, physical activity and the ASSIST, and will offer a leaflet with further explanation about how to address problems with those lifestyles.
16069311|NCT02388230|Device|Ultrasound imaging|
16069312|NCT02388204|Procedure|Implantable spinal cord stimulation|Implantation of SCS electrode and pulse generator
16069313|NCT02388204|Procedure|Implantable spinal cord stimulation|Implantation of SCS electrode and pulse generator
16069314|NCT02388191|Drug|Naproxen sodium|550 mg, oral, on day 1. Number of Cycles: 1
16069315|NCT02388191|Other|Placebo tablet|
16069316|NCT02388178|Drug|Control toothpaste containing no anti-cavity ingredients|Brush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait for 1 minute before rinsing with water.
16069317|NCT02388178|Drug|Experimental toothpaste containing fluoride and amino acid (arginine)|Brush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait for 1 minute before rinsing with water.
16069318|NCT02388178|Drug|Fluoride toothpaste containing fluoride as the anti-cavity ingredient|Brush whole mouth with study toothpaste 2x/day for the 2 week test period. Each brushing routine is 1 minute whole mouth brushing with oral retainer in mouth, spit out toothpaste residue and wait for 1 minute before rinsing with water.
16069319|NCT02388165|Biological|Staphylococcus aureus 4-Antigen (SA4Ag) Vaccine|SA4Ag vaccine reconstituted in 0.5mL water for injection. Administered via IM injection, once 10 to 60 days prior to surgery
16069320|NCT02388165|Other|Placebo|Vaccine excipients reconstituted in 0.5mL water for injections. Administered via IM injection given 10 to 60 days prior to surgery
16069321|NCT02388152|Drug|Lu AF20513, low dose|
16069322|NCT02388152|Drug|Lu AF20513, medium dose|
16069323|NCT02388152|Drug|Lu AF20513, high dose|
16069324|NCT02388152|Drug|Lu AF20513, double high dose|
16069378|NCT02387749|Genetic|mesenchymal stem cells|collection of stem cells by bone marrow biopsy from iliac crest, then culture for 1 month , then IV transfusion on 2 sessions to the same patient
16069325|NCT02388139|Procedure|renal artery angiography|preprocedural renal arteriogram is obtained after sterile preparation and draping of the patient, conscious sedation, infiltration of local anesthetic (lidocaine solution) at the femoral access site, placement of an arterial sheath in the femoral artery, and advancement of the renal guide catheter over a 0.035-in guidewire under fluoroscopic guidance. After the tip of the guide catheter is positioned at the ostium of the renal artery, an angiogram is obtained. After the guidewire is removed, the proximal end of the catheter is connected to a manifold, and 4-8 mL of contrast is manually injected during cineangiographic recording. An intravenous antithrombotic agent, usually heparin, is administered before the clinician proceeds with angioplasty.
16069326|NCT02388139|Procedure|coronarography|
16069327|NCT02388139|Procedure|coronary angioplasty|
16069328|NCT02388139|Procedure|pulse wave velocity measurement|is a measure of arterial stiffness with Sphigmocore device.
16069329|NCT02388139|Procedure|body composition monitoring|using Fresenius device
16069330|NCT02388126|Device|3T multiparametric MRI|Magnetom Verio 3T, Erlangen, Germany
16069331|NCT02388126|Device|Transrectal ultrasound|Bk Medical Pro Focus Ultraview 2202 system
16069332|NCT02388113|Behavioral|accumulated exercise|
16069333|NCT02388113|Behavioral|traditional exercise|
16069334|NCT02388100|Procedure|Capillary HbA1c collection|
16069335|NCT02388087|Device|ROX COUPLER|ROX coupler device is inserted to create an Iliacartero-venous anastamosis following right heart catheterisation.
16069336|NCT02388087|Procedure|Right heart catheterisation and routine care|Participants will have right heart catheterisation followed by routine care. Participants will be blinded to ROX coupler insertion.
16069337|NCT02388074|Device|CyPath®|CyPath® diagnostic assay for the early detection of lung cancer using sputum
16069338|NCT02388061|Drug|Tenecteplase|
16069339|NCT02388061|Drug|Tissue Plasminogen Activator|
16069340|NCT02388048|Drug|Ibrutinib + ofatumumab|
16069341|NCT02388035|Drug|Cefotaxime|
16069342|NCT02388022|Device|Degenerative Disc Disease|lumbar interbody with posterior screw and rod instrumentation
16069343|NCT02388009|Biological|Flexyn2a|Intramuscular doses of 0.5 mL
16069344|NCT02388009|Biological|Placebo|Intramuscular doses of 0.5 mL
16069345|NCT02388009|Biological|Flexyn2a plus adjuvant|Intramuscular doses of 0.5 mL
16069346|NCT02387996|Drug|Nivolumab|
16069347|NCT02387983|Drug|Posaconazole|Posaconazole 300 mg solid oral tablet
16069348|NCT02387970|Procedure|Immediate provisionalization|Stage one protocol: Individuals will receive temporary crowns at the same day as implant surgery, and a final restoration at four months after surgery.
16069349|NCT02387970|Procedure|Delayed provisionalization|Stage two protocol: Individuals will receive temporary crowns 3 months after implant surgery, and a final restoration at four months after surgery.
16069350|NCT02387970|Device|NobelParallel CC implant|Supports the comprehensive range of dental prosthetics as well as full range of prefabricated abutments.
16069351|NCT02387970|Device|Dental crown|"A tooth-shaped cap that is placed over a tooth or implant for teeth restoration and improvement in appearance."
16069352|NCT02387957|Drug|Fovista®|
16069353|NCT02387957|Drug|bevacizumab|
16069354|NCT02387957|Drug|ranibizumab|
16069355|NCT02387957|Drug|aflibercept|
16069356|NCT02387931|Dietary Supplement|Vitamin D3|Nature Made Vitamin D 2000IU, 1 softgel taken daily
16069357|NCT02387931|Dietary Supplement|Fish Oil|Nature Made ultra omega-3 mini fish oil 500mg, 2 soft gels taken daily
16069358|NCT02387931|Other|Placebo|Placebo capsule, 2 taken daily
16069359|NCT02387918|Drug|Dexamethasone|Patients will receive Intravenous dexamethasone 0.15 mg/kg immediately after induction of anesthesia.
16069360|NCT02387918|Device|Acupuncture|Acupuncture treatment (just after induction of anaesthesia and for approximately 20 minutes)
16069361|NCT02387905|Procedure|Management of Therapy Complications|Undergo vertebral body cement augmentation
16069362|NCT02387905|Other|Quality-of-Life Assessment|Ancillary studies
16069363|NCT02387905|Other|Questionnaire Administration|Ancillary studies
16069364|NCT02387905|Radiation|Stereotactic Radiosurgery|Undergo standard stereotactic spinal radiosurgery
16069365|NCT02387892|Dietary Supplement|Cheese & yogurt + Vitamin D|cheese & yogurt with added 420 IU cholecalciferol
16069366|NCT02387892|Dietary Supplement|Cheese & yogurt|Cheese & yogurt without added vitamin D
16069367|NCT02387866|Drug|AG-221|
16069368|NCT02387853|Drug|LEO 90100|
16069369|NCT02387840|Device|Magnetic Resonance Imaging|Patients will have a scan of soft tissue using magnetic field and radio frequency pulses.
16069370|NCT02387840|Device|Magnetic Resonance Fingerprinting|Magnetic resonance fingerprinting (MRF) uses pseudo-randomized variation in acquisition parameters to generate a multi-parametric data signal that can be compared to signal patterns calculated from all possible combinations of parameters of interest. The closest match in signal patterns yields the parameters used to calculate the theoretical signal, in each voxel, and thus a map of all parameters of interest for that tissue. This process allows for rapid quantitation of MR relaxometry values (T1 and T2).
16069371|NCT02387827|Behavioral|Diet+ short term versus long -term physical activity|
16069372|NCT02387814|Drug|Abemaciclib|Administered Orally
16069373|NCT02387801|Drug|Ixekizumab|Administered SC
16069374|NCT02387788|Drug|AKB-9778|Phase 2a open-label study to assess the efficacy and safety of subcutaneous 15mg AKB-9778 administered twice daily for 84 days in subjects with macular edema due to RVO.
16069375|NCT02387775|Device|Esophageal temperature control|"Insertion of the Esophageal Cooling Device (ECD) will take place as described in the product monograph. The ECD will be connected to the heat exchange unit Blanketrol Hyper-Hypothermia System® (Cincinnati Sub-Zero, Cincinnati, OH) and will be used for temperature control for a total of 36 hours. A patient target of 35°C will be set on the heat exchange unit. Once target is attained, it will be maintained for 24 hours. Slow rewarming will then be achieved by increasing the input target by 0.2°C per hour, until a target of 36.6°C is reached.
~All temperature data (device, input target, and patient bladder temperature) will be captured automatically using Data Export Software® (Cincinnati Sub-Zero, Cincinnati, OH) on an external laptop connected to the external heat exchange unit."
16069376|NCT02387762|Drug|acalabrutinib|
16069377|NCT02387762|Drug|Placebo|
16069379|NCT02387736|Behavioral|Dialectical Behaviour Therapy-6 months|Modification of behaviours achieved with reframing thoughts and impulses
16069380|NCT02387736|Behavioral|Dialectical Behaviour Therapy-12 months|Modification of behaviours achieved with reframing thoughts and impulses
16069381|NCT02387723|Biological|Allogeneic adipose derived stem cells (CSCC_ASC)|Culture expanded allogeneic adipose derive stem cells (CSCC_ASC)
16069382|NCT02387710|Drug|Tiagabine|GABA reuptake inhibitor
16069383|NCT02387710|Drug|Placebo|Placebo comparator
16069384|NCT02387697|Device|Edwards Sapien XT Valve|The device will be implanted in the present study to prevent abdominal venous congestion and to improve the function of the tricuspid valve which is located in the low pressure system in the right heart.
16069385|NCT02387671|Behavioral|Device: FitBit Flex wrist band|Participants will track their daily steps walked and hours of sleep by wearing the FitBit Flex wrist band during the 8 week study period. The data collected from the wrist band will be synced to participants' FitBit smart phone application and monitored by the study team.
16069386|NCT02387671|Behavioral|Device: FitBit Aria weight scale|Participants will record their daily body weight during the 8 week study period by stepping on the FitBit Aria weight scale. The data collected from the scale will be synced to participants' FitBit smart phone application accounts and monitored by the study team.
16069387|NCT02387671|Behavioral|Diet Intake Messages|The study team will send participants daily text messages regarding their dietary intake. Each message will contain five questions that yield a yes, or no response. Messages will be sent daily during the 8 week study period. Responses from the messages will be recorded and monitored by the study team to enhance the behavioral counseling intervention.
16069388|NCT02387671|Behavioral|Behavioral Counseling|Participants will engage in four phone calls with the study counselor to discuss behavioral several topics (physical activity, sleep, fatigue & dietary patterns) and to reflect on their data recorded by the FitBit devices. The calls will take place on a bi-weekly basis. During the weeks between calls, the counselor will maintain contact with the participants through asynchronous text messages to monitor their progress in the study.
16069389|NCT02387658|Procedure|translesional gradient measurement|Patients will be stratified into two groups based on the final mean translesional pressure gradient obtained in the femoropopliteal arterial bed after revascularization or just after angiography if no revascularization is done.
16069390|NCT02387645|Procedure|Lavage of the Uterus|The lavage will be performed in the operating theatre under general anesthesia. The ALPINE technique includes the following steps. A three way catheter (catheter for uterine and tubal lavage) is inserted into the cervical canal and a balloon is inflated to seal the cervical canal. The patient is put into anti-Trendellenburg positioning. Normal saline is slowly flushed into the uterine cavity and proximal tubes. After the lavage is finished, the balloon is deflated and the catheter is removed. A cap is put on the collection syringe and the syringe is sent to the laboratory.
16069391|NCT02387619|Drug|Rosuvastatin|Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin once daily for 9 days
16069392|NCT02387619|Drug|Telmisartan/Amlodipine|Rosuvastatin and Telmisartan/Amlodipine: Telmisartan/Amlodipine once daily for 9 days
16069393|NCT02387619|Drug|Rosuvastatin and Telmisartan/Amlodipine|Rosuvastatin and Telmisartan/Amlodipine: Rosuvastatin and Telmisartan/Amlodipine once daily for 9days
16069394|NCT02387606|Drug|Placebo|Participants will receive placebo once daily.
16069395|NCT02387606|Drug|JNJ-53718678|Participants will receive JNJ-53718678 as 20 milliliter (mL) (200 mg) or 50 mL (500 mg) oral solution (containing 10 mg JNJ-53718678 per mL) in Cohort 1. JNJ-53718678 dose in Cohort 2 will be decided based on Cohort 1 results. JNJ-53718678 as 7.5 mL (75 mg) oral solution (containing 10 mg JNJ-53718678 per mL) in Cohort 3.
16069396|NCT02387593|Device|ENDOCUFF|One endocuff device is placed at the tip of colonoscope prior to colonoscopy baseline
16069397|NCT02387580|Drug|OZ439 + TPGS|
16069398|NCT02387580|Drug|OZ439 Prototype 1|
16069399|NCT02387580|Drug|OZ439 Prototype 3|
16069400|NCT02387580|Drug|PQP|
16069401|NCT02387567|Drug|Lidocaine|Paraspinal block with 3ml lidocaine injection at 1%.
16069402|NCT02387567|Drug|Sham Lidocaine|Sham injection, without lidocaine.
16069403|NCT02387567|Other|Standard treatment|Standard treatment only, without lidocaine or sham injection.
16069404|NCT02387554|Drug|HGP0904|
16069405|NCT02387554|Drug|HGP0608|
16069406|NCT02387554|Drug|HGP1405|
16069407|NCT02387528|Behavioral|1- Mindfulness Intervention|An intervention program integrating elements of Mindfulness Breathworks Institute Mindfulness based approaches for Pain and illness (MBPI), (Burch , 2009) and Mindfulness Based Stress Reduction (MBSR), (Kabat Zinn, 2003), and Mindfulness based Cognitive Therapy (MBCT) shall be used. All programs are highly structured, lasting eight weeks, with a weekly meeting about two hours , and working with four main techniques during these meetings : mindfulness in breathing, body scan, walking meditation and mindfulness yoga. In order to facilitate the home practice of meditation by participants during and after the intervention protocol, all will receive a CD containing guided meditation sessions, covering the above techniques.
16069408|NCT02387528|Behavioral|2- Relaxation Intervention|Eight meetings where the participants will practice relaxation techniques.
16069409|NCT02387528|Other|3- Wait List Control Group|No intervention
16069410|NCT02387515|Other|intensive rehabilitation program|Patients will follow an intensive rehabilitation program (2x/week for 18 weeks), with emphasis on motor control training that is supported by technology. The technological system consists out of motion tracking sensors that register the movements and position of the lumbar spine.
16069411|NCT02387502|Device|Intubation- Macintosh laryngoscope|Difficult intubation was simulated by using rigid neck collar. Then patients were intubated according to the assigned laryngoscopes. In Macintosh group, tip of the laryngoscope blade was placed in the vallecula and epiglottis was lifted. After visualization of the vocal cord, patients were intubated.
16069412|NCT02387502|Device|Intubation- MacCoy laryngoscope|In MacCoy group, tip of the laryngoscope blade was placed in the vallecula and lever was pressed to flex the tip. After visualization of the vocal cord, patients were intubated.
16069413|NCT02387502|Device|Intubation- Airtraq laryngoscope|In Airtraq group, the laryngoscope was loaded with endotracheal tube. Airtraq laryngoscope was inserted through midline and after visualization of image of vocal cord through its eyepiece, endotracheal tube was passed.
16069493|NCT02386943|Drug|Saxagliptin|5mg po once.
16069494|NCT02386943|Drug|Blank control|No medication is taken.
16069414|NCT02387489|Behavioral|Brief in-person motivational intervention|Brief in-person motivational intervention tailored to participants' risk behaviors, delivered by a nurse.
16069415|NCT02387489|Behavioral|Computerized Brief Intervention|Computer-delivered motivational intervention tailored to participants' risk behaviors.
16069416|NCT02387476|Device|FRESCA mask first night|FRESCA nasal mask first night
16069417|NCT02387476|Device|CPAP Mask first night|CPAP Nasal Mask first night
16069418|NCT02387450|Drug|Sildenafil|100 mg per day
16069419|NCT02387450|Drug|Placebo|Placebo with same presentation as the active drug
16069420|NCT02387437|Behavioral|SI recruitment|SI continuous positive airway pressure (CPAP) held at 40 cm H2O for 40 secs.
16069421|NCT02387437|Behavioral|IP recruitment|Incremental positive end-expiratory pressure (PEEP) with a fixed peak pressure (IP), PEEP increased in 5 cm H2O increments (allowing 30 secs/step) from a baseline PEEP of post-trial to 40 cm H2O while decreasing tidal volume to limit peak inspiratory pressure to 40 cm H2O. After CPAP of 40 cm H2O was held for 30 secs, PEEP was decremented in 5-cm H2O steps to the post-RM PEEP setting, while increasing tidal volume toward the baseline value of 10 mL/kg (as the 40 cm H2O peak pressure limit allowed).
16069422|NCT02387437|Behavioral|PCV recruitment|PCV peak pressure = 40 cm H2O, inspiratory to expiratory ratio = 1:2, and PEEP level = 15cm H2O for 2 min
16069423|NCT02387424|Behavioral|MBCT-PD|The 8-session MBCT protocol, with modifications for use in the context of pregnancy and in anticipation of the postpartum.
16069424|NCT02387424|Behavioral|OAR|Ongoing Assessment and Referral (OAR) consists of routine screening and referral to behavioral health services within obstetric clinical settings within Kaiser Permanente (KP) in Colorado and Georgia.
16069425|NCT02387411|Other|High-intensity interval exercise training|High-intensity interval exercise training [4 reps * (4 min at 80% VO2peak + 3 min at 50% VO2peak)]
16069426|NCT02387411|Other|Combined exercise training|High intensity [2 reps * (4 min at 80% VO2peak + 3 min at 50% VO2peak)] and strength exercise training (2-4 sets, 10-12 reps, 60-65% 1RM, for quadriceps and hamstrings, 14 min in total)
16069427|NCT02387398|Procedure|Early Angiography|Coronary Angiography within 120 minutes of admission for out-of-hospital cardiac arrest with ROSC
16069428|NCT02387385|Device|Whole body cooling (Tecotherm)|Whole body cooling to 33 to 34 C using Tecotherm
16069429|NCT02387372|Drug|Ceftolozane/Tazobactam - Multiple Doses|"4-6 doses of ceftolozane/tazobactam every 8 hours as a 60-minute intravenous infusion as follows:
~Participants with CLCR > 50 mL/min will receive 4-6 doses of 3 g ceftolozane/tazobactam every 8 hours
~Participants with CLCR 30 - 50 mL/min will receive 4-6 doses of 1.5 g ceftolozane/tazobactam every 8 hours
~Participants with CLCR 15 - 29 mL/min will receive 6 doses of 750 mg ceftolozane/tazobactam every 8 hours"
16069430|NCT02387372|Drug|Ceftolozane/Tazobactam - Single Dose|Single dose of ceftolozane/tazobactam, 3 g, as a 60-minute intravenous infusion
16069431|NCT02387359|Drug|Plecanatide|
16069432|NCT02387359|Drug|Placebo|
16069433|NCT02387346|Device|Magstim Rapid 2 Repetitive Transcranial Magnetic Stimulation|
16069434|NCT02387346|Device|Magstim Rapid 2 Sham Stimulation|
16069435|NCT02387333|Procedure|Polypropylene Mesh Stoma reinforcement technique with ileal conduit urinary diversion|"After standard steps of radical cystectomy and sparing of distal 15 cm of ileum as a conduit for diversion.
~A preferred rectal muscle splitting approach is preferred for IC exteriorization.
~Dissection of subcutaneous fat off the rectus sheath will be accomplished to create a potential space for mesh placement.
~Then, 5 x 5 cm polypropylene mesh will be placed and incised at the center to create an orifice to allow IC exteriorization.
~The mesh is then fixed to underlying rectus sheath with 1-0 non-absorbable proline sutures.
~The IC is exteriorized through the central orifice and then fixed to the peritoneum and to the cut-edges of the rectus muscle using 3-0 polyglactin sutures.
~A 12 CH subcutaneous tube drain will be left and the subcutaneous tissue is closed to collapse the dissected space around the mesh.
~The stoma is then everted and fixed to the skin."
16069436|NCT02387333|Procedure|Ileal conduit urinary diversion|In this group, no mesh will be applied with ileal conduit urinary diversion
16069437|NCT02387320|Other|Self-Care Toolkit|The self-care toolkit was designed and created for individuals undergoing surgery and/or invasive medical procedures. It provides individuals with guided instruction to learn several evidence-informed mind-body skills (e.g., breathing, relaxation, meditation, guided imagery) and tools (e.g., acupressure wristbands, journal) in order to regulate their own physiologic and emotional reactions to stressful situations and to lessen symptoms associated with surgery (principally pain, anxiety, nausea, fatigue, sleep disturbance).
16069438|NCT02387307|Drug|rSIFN-co|rSIFN-co is a drug developed by Sichuan Huiyang Life Science and Technology Corporation for the treatment of solid tumors especially in non-small cell lung cancer and other tumor types. The study comprises of 2 stages: the dose-escalation stage and dose expansion stage.
16069439|NCT02387294|Biological|Vaccination with Fluval AB Novo suspension for injection, half dose of a single intramuscular dose (0.25 ml)|vaccination
16069440|NCT02387294|Biological|Vaccination with Fluval AB Novo suspension for injection, single intramuscular dose (0.5 ml)|vaccination
16069441|NCT02387268|Device|CleanC system|Cleansing liquid and fecal matter during a standard colonoscopy procedure
16069442|NCT02387255|Device|Resoundant Driver System|This device is used to generate vibrations at the area of interest. The device has an active driver, a loud speaker sitting outside the scanner area, and a passive driver, which is shaped like a silicone paddle, which is secured with velcro straps to the area being imaged. Sound waves from the active driver travel through a tube attached to the passive driver and generate vibrations, images of which are captured by the MR scanner.
16069443|NCT02387242|Drug|Rifampicin|Single oral dose of rifampicin
16069444|NCT02387229|Drug|Rivaroxaban|15 mg
16069445|NCT02387229|Other|standard of care|
16069446|NCT02387216|Drug|MM-121|Investigational, fully human antibody targeting and inhibiting ErbB3
16069447|NCT02387216|Drug|Docetaxel|approved chemotherapy treatment for NSCLC
16069448|NCT02387203|Drug|PrevPac (Prevacid, Amoxicillin, Clarithromycin)|30mg Prevacid, 1g amoxicillin, 500mg clarithromycin administered together for oral use, twice daily for 14 days preoperatively and twice daily for 14 days at least 4 weeks postoperatively
16069603|NCT02386046|Other|Pulse oxymeter measurements|Pulse oxymeter measurements done at the hospital and upon discharge, weekly until 46 weeks postconceptional age
16069604|NCT02386033|Drug|Atorvastatin (ATV)|After SRP, ATV gel was delivered subgingivally into the pocket
16069449|NCT02387190|Other|Telenursing monitoring|"The telenursing program protocol is based on:
~Contact the patient by telephone, weekly;
~Distribution and explanation of the educational booklet;
~Filling a diary of symptoms and signs; 4) Record, management and markdown visits in case of non-elective visits, hospitalization or fatal episodes. Also, the following aspects shall be observed: help requests associated with illness, adaptations for living with the disease, effects of drugs in daily life, availability of financial resources for disease management, self-image; emotional and social support."
16069450|NCT02387177|Behavioral|Stress Management Group 1|Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.
16069451|NCT02387177|Behavioral|Stress Management Group 2|Subjects will attend group stress management sessions via Skype once weekly for 8 weeks and learn stress/NF symptoms managements techniques.
16069452|NCT02387164|Drug|Alum-GAD|Two doses à 20 microgram 30 days apart subcutaneously administrated
16069453|NCT02387164|Drug|Vitamin D3|2000 Units (IE) (50 microgram) vitamin D3 daily
16069454|NCT02387151|Drug|mesenchymal stromal cells|2 doses of 1-2x10^6 allogeneic bone marrow derives MSCs IV per/kg body weight at weeks 25 and 26 after transplantation
16069455|NCT02387138|Drug|S-1|"S-1: Administered orally twice daily from day 1 for 7 consecutive days followed by a 7-day recovery period in a 14-day cycle.
~The starting dose of S-1 will be two levels below the recommended dose defined in SIRI (20 mg/m² BID minimum) with a cohort dose escalation by 5 mg/m² increments (5 dose levels)."
16069456|NCT02387138|Drug|Irinotecan|Irinotecan : fixed dose of 180 mg/m² IV over 90 minutes on d1 of every cycle
16069457|NCT02387138|Drug|Oxaliplatin|Oxaliplatin : fixed dose of 85 mg/m² over 120 minutes on d1 of every cycle
16069458|NCT02387138|Other|G-csf|G-csf : d8 to d13 systematically
16069459|NCT02387125|Biological|CMB305|
16069460|NCT02387125|Biological|G100|
16069461|NCT02387125|Drug|Metronomic CPA|
16069462|NCT02387112|Device|Early VAD implantation|Implantation of a left ventricular assist device
16069463|NCT02387099|Drug|3 weeks Dose Induction of Everolimus|"Comparing a conventional dosing approach starting with 10 mg at first dose versus a dose-escalating schema over 21 days in patients receiving everolimus in combination with exemestane for treatment of metastatic breast cancer.
~All patients will be treated within the approved indication of everolimus in combination with exemestane.
~Patients will be randomized in a 1:1 ratio"
16069464|NCT02387099|Drug|3 weeks Conventional Everolimus Dosing|"Comparing a conventional dosing approach starting with 10 mg at first dose versus a dose-escalating schema over 21 days in patients receiving everolimus in combination with exemestane for treatment of metastatic breast cancer.
~All patients will be treated within the approved indication of everolimus in combination with exemestane.
~Patients will be randomized in a 1:1 ratio"
16069465|NCT02387099|Drug|Open Label Phase with conventional 10mg Everolimus Dosing week 4-24|All patients will receive open label Everolimus with Exemestane for 21 weeks according to label
16069466|NCT02387099|Drug|Standard Care after 24 weeks|It is up to the discretion of the investigator to continue with Everolimus+Exemestane beyond 24 weeks
16069467|NCT02387086|Drug|Thalidomide|
16069468|NCT02387086|Drug|placebo|
16069469|NCT02387086|Drug|Gefitinib|
16069470|NCT02387086|Drug|Aspirin|
16069471|NCT02387073|Other|Electrical version patient reported outcome questionnaire|"Assess satisfaction of patients with electrical version patient reported outcome questionnaire."
16069472|NCT02387060|Drug|H-Bupivacaine|Intrathecal administration of hyperbaric bupivacaine 1.5 ml 0.75%
16069473|NCT02387060|Drug|Fentanyl|Intrathecal administration of fentanyl 25 mcg
16069474|NCT02387034|Behavioral|Physical activity on prescription|Participants meet a physiotherapist for 60 minutes, get information about osteoarthritis, physical activity and weight control and a patient-centered counselling about physical activity related to the disease. It leads to a Swedish Physical activity on prescription (PAP). It is an individualized written prescription on physical activity and includes specific mode of physical activity. The patient is contacted by telephone or visit the physiotherapist after three weeks, three months and six months.
16069475|NCT02387034|Other|General advice|Participants meet a physiotherapist for 60 minutes, get information about osteoarthritis, physical activity and weight control and receive an intervention with general advice about physical activity
16069476|NCT02387021|Procedure|Continuous femoral nerve block|
16069477|NCT02387021|Procedure|Continuous adductor canal block|
16069478|NCT02387021|Procedure|infragluteal Sciatic nerve block|
16069479|NCT02387021|Drug|Ropivacaine 0.2%|
16069480|NCT02387021|Drug|Saline|
16069481|NCT02387008|Device|GUIDOR® membrane with FDBA|horizontal bone augmentation with synthetic GUIDOR® membrane + FDBA
16069482|NCT02387008|Device|GUIDOR® membrane|horizontal bone augmentation with synthetic GUIDOR® membrane
16069483|NCT02387008|Device|Bio-Gide® membrane with FDBA|xenograft BioGide® membrane + FDBA
16069484|NCT02386995|Device|BIS monitor|Both types of depth of anesthesia monitoring (BIS and entropy- electrodes) are applied on patients together with standard monitoring (heart rate, blood pressure, respiratory rate). The two different types of depth of anesthesia monitoring are then compared.
16069485|NCT02386995|Device|Entropy monitor|Both types of depth of anesthesia monitoring (BIS and entropy- electrodes) are applied on patients together with standard monitoring (heart rate, blood pressure, respiratory rate). The two different types of depth of anesthesia
16069486|NCT02386982|Drug|HMS5552|
16069487|NCT02386969|Device|active rTMS then sham rTMS|A first period during which the patient will have 1 session of active rTMS every 3 weeks for 3 months A 2nd period during which the patient will have 1 session of sham rTMS every 3 weeks for 3 months
16069488|NCT02386969|Device|sham rTMS then active rTMS|A first period during which the patient will have 1 session of sham rTMS every 3 weeks for 3 months A 2nd period during which the patient will have 1 session of active rTMS every 3 weeks for 3 months
16069489|NCT02386956|Other|Active stretching|10 minutes of active stretching of the posterior muscle chain with RPG techniques
16069490|NCT02386956|Other|Dynamic Stretching|10 minutes of dynamic stretching of the sciatic nerve and the posterior muscle chain with manual techniques of mobilization the nerves
16069491|NCT02386956|Other|Control|10 minutes with the patient lying on a machine off of magnetotherapy
16069492|NCT02386943|Drug|Sitagliptin|100mg po once.
16069495|NCT02386930|Behavioral|Behvarioal lifestyle modification|A six months behavioral lifestyle program composed of 8 sessions; 4 individual consultations and 4 telephonic calls. The cognitive behavior theory (CBT) is the underpinning theory for the lifestyle intervention; hence CBT behavioral strategies like self monitoring and goal setting are used to improve compliance to healthy lifestyle practices
16069496|NCT02386917|Procedure|Gastric bypass|Weight loss surgery
16069497|NCT02386917|Behavioral|Very low calorie diet|Non-surgical weight loss procedure
16069498|NCT02386904|Drug|Phosphate Enema (Kleen® Enema)|120ml (single bottle) administered via rectal route before 30min of sigmoidoscopy .
16069499|NCT02386891|Other|Thermal Environment|
16069500|NCT02386878|Behavioral|Interpersonal Psychotherapy for Groups (IPTG)|Interpersonal psychotherapy is a theory- and evidence-based treatment approach for depression developed by clinicians. World Vision has helped to pioneer the use of this model in sub-Saharan Africa including adapting the model for use with OVC within South Africa. Sessions are designed to provide participants with opportunities to learn and practice interpersonal skills for solving problems that bring about depression, and to facilitate the provision of emotional support between members of the group. Groups are implemented by a trained adult facilitator from the community who helps participants to identify people who are important in their lives, understand links between their psychological state and current problems, and practice new ways of problem-solving.
16069501|NCT02386878|Behavioral|Vhutshilo 2|The Vhutshilo 2 model was developed in 2008 by the Centre for the Support of Peer Education (CSPE), a branch of the South African non-profit organization Health and Education Training and Technical Assistance Services. The Vhutshilo program was designed specifically for adolescent OVC in South Africa, and attends to risk factors and pathways considered particularly relevant for this population. Topics include finding and giving emotional support; dealing with grief and loss; alcohol and substance abuse; crime and sexual violence; HIV/AIDS; healthy and safe sexual relationships; and transactional sex. In addition to its knowledge component, the program places heavy emphasis on building relevant skills and efficacy.
16069502|NCT02386852|Drug|Placebo|Study subjects received, in a double blind fashion, placebo pills identical to the drug (drug 1-ginseng, group 1; drug 2-ginkgo biloba-group 2)
16069503|NCT02386852|Drug|Ginseng|The ginseng group received two capsules containing either 1000 mg or 500 mg of Panax Ginseng extract standardized to 3% of ginsenosides (GNC, USA) or similarly looking placebo capsules over a period of three days of testing.
16069504|NCT02386852|Drug|Ginkgo Biloba|The ginkgo group received two capsules containing either 240 mg or 120 mg of ginkgo biloba extract standardized to 24% ginkgo flavone glycosides and 6% terpene lactones (GBE24/6) or similarly looking placebo capsules over a period of three testing days.
16069505|NCT02386839|Drug|rhIGF-1/rhIGFBP-3|"Participants who received rhIGF-1/rhIGFBP-3 in study ROPP-2008-01 (NCT01096784) will be enrolled to this study. No investigational product will be administered in this study."
16069506|NCT02386826|Drug|INC280|"Dose Escalation: INC280 by mouth (PO) twice daily for 28 days according to the following schedule until the maximum tolerated dose (MTD) is determined:
~Dose Level 1 (starting dose): 200 mg (divided dose of 100 mg twice per day) Dose Level 2: 400 mg (divided dose of 200 mg twice per day) Dose Level 3: 800 mg (divided dose of 400 mg twice per day)
~Dose Expansion: INC280 PO twice daily at the MTD determined in the dose escalation phase"
16069507|NCT02386826|Biological|bevacizumab|bevacizumab: 10 mg/kg IV every 2 weeks. Patients with unresectable GBM will be given 15 mg/kg IV every 4 weeks.
16069508|NCT02386800|Drug|ruxolitinib tablets or oral pediatric formulation, panobinostat capsules|ruxolitinib tablets or oral pediatric formulation, panobinostat capsules
16069509|NCT02386800|Drug|ruxolitinib tablets or oral pediatric formulation|ruxolitinib tablets or oral pediatric formulation
16069510|NCT02386787|Device|Ultrasonography|an ultrasonography will be conducted before the anesthesic procedure to provide reliable quantitative information about the volume of gastric content.
16069511|NCT02386774|Device|Handheld IVCM Vivascope 3000 (Caliber/Mavig) anesthesic eyedrop : oxybuprocaïne Thea 1,6 mg/0,4 ml|used anesthesic eyedrop : oxybuprocaïne Thea 1,6 mg/0,4 ml
16069512|NCT02386774|Device|Multifluorescence IVCM vivascope 1500 ML (Caliber/Mavig)|"used for Multifluorescence IVCM
~anesthesic eyedrop : oxybuprocaïne (1,6 mg/0,4 ml)
~Fluorescein 0,5%, Rose Bengal , Infracyanine"
16069513|NCT02386774|Procedure|microangiography|realization of the microangiography with intravenous injection of fluoresceine and indocyanine green.
16069514|NCT02386761|Drug|Single Ascending Dose (SAD)|
16069515|NCT02386761|Drug|Multiple Ascending Dose (MAD)|
16069516|NCT02386748|Dietary Supplement|Chewing gum|Chewing sugarless gum after the discharge from the operating room by two hours for at least half an hour at two hours intervals.
16069517|NCT02386748|Dietary Supplement|Oral fluids|Starting clear oral fluids after operating room discharge by six hours, then hearing intestinal sounds on second day before initiating full regular diet.
16069518|NCT02386748|Other|Intravenous fluids|Women in this group will not receive neither gum nor oral fluids, they will be on intravenous fluids (lactated ringer solution).
16069519|NCT02386735|Drug|Placebo|Three days prednisone 40mg, two days placebo
16069520|NCT02386735|Drug|Prednisone|Five days prednisone 40mg.
16069521|NCT02386722|Device|Smartinhaler/POEMS with audio reminders and additional support calls|Patients assigned to the intervention group will receive a Smartinhaler/POEMS, which will contain an audio reminder function. If the alarm function is on, a ring tone will be generated, after the time predesigned for inhalation. If the use of rescue medication doubles or if the inhaled medication is not inhaled as prescribed for more than two consecutive days, the investigator will call them to see if they need help and to find out the reason for non-adherence.
16069522|NCT02386709|Device|FDG PET|FDG PET1 before neoadjuvant chemotherapy FDG PET2 after one cycle of neoadjuvant chemotherapy
16069523|NCT02386696|Other|Ultrasound|Lung ultrasound examination on healthy volunteers
16069524|NCT02386683|Other|lung-protective ventilation|mechanical ventilated with a tidal volume of 6-8ml/kg ideal body weight (IBW) and 6-8 cm H2O PEEP in anesthesia
16069553|NCT02386475|Drug|citalopram|In all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association.
16069605|NCT02386033|Drug|Placebo Gel|After SRP, placebo gel was delivered subgingivally into the pocket
16069525|NCT02386670|Other|tDCS + CR|"First, the intervention sessions will be administered 5 days/week for 8 weeks (induction phase). Then, for 5 days once every 6 months (consolidation phase).
~tDCS session: anode over Fz & cathode over Iz; direct current: 2 mA (current density=0.57A/m2) for 30 min. at the beginning of each group session.
~Cognitive Remediation (CR) will also be administered. Sessions last 2 hours each day in a group supervised by trained interventionists. Participants will also complete CR exercises online at home. CR will consist of computer-based exercises relevant to attention, processing speed, executive function, and verbal and working memory with titrated difficulty levels. Performance feedback will reinforce progress. Strategic monitoring and bridging discussions will promote transfer of cognitive gains to everyday tasks.
~During COVID-19, booster sessions can be provided either in-person or virtually (except for tDCS that cannot be done remotely)."
16069526|NCT02386670|Other|sham tDCS + sham CR|"First, the intervention sessions will be administered 5 days/week for 8 weeks (induction phase). Then, for 5 days once every 6 months (consolidation phase).
~tDCS session: anode over Fz & cathode over Iz; direct current: 2 mA (current density=0.57A/m2) for 1 minute, then the current will be 0 mA for 29 minutes at the beginning of each group session.
~Cognitive Remediation (CR) will also be administered. Sessions last 2 hours each day in a group supervised by trained interventionists. Participants will also complete CR exercises online at home. CR will consist of computer-based exercises relevant to attention, processing speed, executive function, and verbal and working memory without titrated difficulty levels.
~During COVID-19, booster sessions can be provided either in-person or virtually (except for sham tDCS that cannot be done remotely)."
16069527|NCT02386657|Other|Satisfaction|Satisfaction questionnaire to be filled in
16069528|NCT02386657|Other|Biological parameters|Measure of standard routine biological parameters (Hb, GB, Plaq, LDH, CRP, TCA, INR, D Dimers) and dosage of nitrous albumin (PNA).
16069529|NCT02386657|Other|Pain management|Validated pain scale questionnaire to be filled in
16069530|NCT02386644|Other|PAMG-1 Immunoassay|Immunoassay for presence of placental alfa microglobulin-1(PAMG) in vaginal fluids.
16069531|NCT02386644|Device|Ultrasound transperineal assessment|Transperineal ultrasound assessment of vaginal canal for pooling of amniotic fluid.
16069532|NCT02386644|Device|Ultrasound amniotic fluid index measurement|Calculation of amniotic fluid index in millimetres via ultrasonography by measuring four deepest pockets in four quadrants.
16069533|NCT02386644|Other|Speculum examination|Sterile speculum examination to evaluate vaginal pooling of amniotic fluid pooling.
16069534|NCT02386644|Other|Nitrazine test|To assess acid , alkaline status of pooled fluid in vagina.
16069535|NCT02386631|Device|Custom Made Orthotic|Provides longitudinal arch support
16069536|NCT02386618|Procedure|Standardized endoscopic treatment of local residual neoplasia|Endoscopic treatment will be performed according to the type of local residual neoplasia (LRN): A - endoscopically negative scar and neoplastic tissue found only in biopsy specimens - treatment by argon plasmacoagulation, B - endoscopically aparent LRN < 5 mm - forceps biopsy + argon plasmacoagulation, C - endoscopically evident LRN > 5 mm + lifting during submucosal injection - endoscopic mucosal resectio + argon plasmacoagulation, D - endoscopically evident LRN > 5 mm + non-lifting during submucosal injection - endoscopic submucosal disection (ESD) or surgical resection
16069537|NCT02386605|Behavioral|Motivational Interviewing and Cognitive Behavioral Therapy|group-based recovery-oriented Motivational Interviewing combined with cognitive-behavioral therapy to target the negative symptoms of schizophrenia
16069538|NCT02386605|Behavioral|Relaxation Skills|Relaxation and mindfulness skills training group for comparison condition for negative symptoms of schizophrenia
16069539|NCT02386592|Drug|Chlorhexidine gluconate (CHG)|All enrolled neonates admitted to the NICU during the implementation and intervention periods will undergo CHG bathing (sparing head and face) at the time of admission at and thereafter once weekly.
16069540|NCT02386592|Behavioral|Hand hygiene (HH)|Alcohol hand rub will be produced in the hospital pharmacy and will be readily available in the NICU (via wall-mounted dispensers) throughout the intervention period. Hand hygiene among NICU physicians and nurses will actively be promoted through the intervention period.
16069541|NCT02386592|Behavioral|Infection control training|All NICU healthcare workers will receive infection prevention training which will involve structure training on HH, universal precautions, neonatal skin antisepsis and peripheral IV placement and line care.
16069542|NCT02386592|Other|Infection control reminders via SMS text|Infection control practice reminders will be sent to NICU healthcare workers on a daily basis via SMS messages.
16069543|NCT02386579|Procedure|Blood sample measurements|Blood samples are drawn in the feet and arms (a/v) before and after cooling the feet with ice water
16069544|NCT02386566|Drug|natalizumab|As described in the treatment arm
16069545|NCT02386553|Drug|Nusinersen|Solution for intrathecal injection
16069546|NCT02386540|Behavioral|Health Coaching|The Alameda County Health Coach program pairs patients with a language-concordant health coach for six months following an ED visit. Health coaches are young adults from the local community employed through Alameda County and trained for three months in topics such as self-management support and motivational interviewing. Health coaches work one-on-one with participants in order to develop an action plan in order to achieve patient-identified health goals. Communication between the health coach and participant includes text messages (weekly), phone calls (twice a month), face-to-face visits (at least once), and accompaniment to a primary care visit (at least once). Health coaches may also assist participants in accessing community resources as related to the individualized action plan.
16069547|NCT02386501|Drug|ADXS31-164|
16069548|NCT02386488|Drug|Vortioxetine 10 mg single dose|10 mg tablet for oral use, single dose
16069549|NCT02386488|Drug|Vortioxetine 20 mg single dose|Two 10 mg tablets for oral use, single dose,
16069550|NCT02386488|Drug|Vortioxetine 10 mg multiple dose|10 mg tablet for oral use once, daily for 14 days.
16069551|NCT02386488|Drug|Vortioxetine 20 mg multiple dose|Two 10 mg tablets for oral use, once daily for 14 days.
16069552|NCT02386475|Other|placebo|In all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association.
16069602|NCT02386059|Drug|Dexamethasone + Ondansetron|4 mg dexamethasone, intravenously at the start of surgery and 4 mg ondansetron intravenously 15 minutes before the end of surgery.
16069554|NCT02386475|Drug|sinemet plus|In all cases, regardless of the assigned treatment group, will follow usual physiotherapy program and vascular risk factors, and treatment of stroke will be controlled according to current recommendations of the American Heart Association / American Stroke Association.
16069555|NCT02386462|Drug|Dexmedetomidine|The modified Dixon's up-and-down method was used to determine the bolus dose of dexmedetomidine, starting from 1.0μg/kg (step size; 0.1μg/kg)
16069556|NCT02386462|Drug|Propofol|
16069557|NCT02386449|Drug|sodium picosulfate, magnesium oxide and citric acid (Picoprep®)|
16069558|NCT02386449|Drug|mannitol|
16069559|NCT02386449|Drug|Bisacodyl|
16069560|NCT02386436|Drug|GSK2330811|GSK2330811 will be supplied as clear or opalescent, colourless, yellow to brown liquid administered as single dose s.c.
16069561|NCT02386436|Drug|Placebo|Placebo will be supplied as Normal Saline (0.9% weight by volume [w/v] Sodium Chloride) administered as single dose s.c.
16069562|NCT02386423|Device|RESTIFFIC™ Brand Pressure Application System|The device, RESTIFFIC™, was administered intermittently through the course of the study: one-week baseline period without the device (days 1-7), three weeks of initial testing with the device (days 8-28), a subsequent one-week period without the device (days 29-35), and three weeks of subsequent testing with the device (days 36-56).
16069563|NCT02386410|Behavioral|Group parent training for anxious parents|
16069564|NCT02386410|Behavioral|Internet delivered parent training for anxious parents|
16069565|NCT02386397|Drug|Regorafenib|Regorafenib: X mg/d, PO, from day 1 to day 14; day 15 to day 20: off-treatment
16069566|NCT02386397|Drug|GEMOX|mGEMOX: infusion on days 1 and 8: Gemcitabine 900 mg/m² IV in 30 minutes Oxaliplatin 80 mg/m² IV in 120 minutes immediately after Gemcitabine
16069567|NCT02386371|Procedure|tumorectomy|"Tumorectomy will be performed according to the current standards, obtaining clear margins. The axillary lymph node control will depend on the initial management (clinical and ultrasound) of these N0 patients, chosen by the teams."
16069568|NCT02386371|Radiation|Intra Operative Radiotherapy|After the excision of the tumor, IORT will be delivered. A single dose of 20 Gy by 50 kV photons (Intrabeam™) will be administered in tumor bed. The addition of IORT does not modify the surgical procedure
16069569|NCT02386358|Drug|Benznidazole|Benznidazole at a dose 5 mg/Kg/day until 60 days have been completed or development of non-acceptable toxicity-
16069570|NCT02386358|Drug|Placebo|Placebo at a dose 5 m/Kg/day until 60 days
16069571|NCT02386332|Procedure|transplantation|
16069572|NCT02386319|Drug|Melatonin|Gelatin capsules
16069573|NCT02386319|Drug|Placebo|Placebo capsules
16069574|NCT02386306|Drug|GC021109|
16069575|NCT02386306|Other|Placebo|
16069576|NCT02386293|Drug|Irbesartan|Double blind placebo controlled cross over trial to determine effectiveness of an angiotensin receptor blocker in obese hypertensive African American patients.
16069577|NCT02386293|Other|Placebo|Sugar pill made to look identical to irbesartan intervention.
16069578|NCT02386280|Behavioral|Motivational Interviewing for Change of Parenting Styles|
16069579|NCT02386280|Behavioral|Psicoeducation|
16069580|NCT02386267|Drug|L-leucine|L-leucine pills per os for 6 months
16069581|NCT02386241|Other|saliva or blood sample collection|Single saliva or blood sample measuring 10mL for genomic analysis.
16069582|NCT02386228|Genetic|collection of CSF and blood|collection of CSF and blood
16069583|NCT02386215|Behavioral|HIV self-test|"Two self-test kits will be distributed to women, each containing the following:
~One standard OraQuick ADVANCE I/II test kit
~Written pre-test information including test instructions in written and pictorial form
~A phone number that participants can call to obtain additional information
~Two vouchers with unique identifying numbers which can be redeemed at confirmatory testing"
16069584|NCT02386202|Other|No intervention|No interventions
16069585|NCT02386189|Behavioral|Patient Care Coordination Training|Veterans in this group will share a comprehensive list of all of their providers (VA and non-VA) at future appointments. He/she will also be trained on how to create a VA Health Summary in My HealtheVet to share with their non-VA providers and how to use their community portals (if available) to share information back to VA providers. A VA and non-VA provider visit will be evaluated.
16069586|NCT02386163|Biological|MSC from synovial membrane and infrapatellar Fat Pad|
16069587|NCT02386150|Biological|RVEc|The composition of the final drug product, prior to any dilution, is 0.2 mg recombinant ricin toxin 1-33/44-198 (RVEc) in buffer and 0.2% Alhydrogel® at a final volume of 1 mL per vial
16069588|NCT02386137|Device|Contrast-enhancement ultrasound with Sonovue|
16069589|NCT02386124|Other|frailty evaluation|assessment of mental and physical frailty before discharge from cardiac departement
16069590|NCT02386111|Drug|Combination of varlilumab and sunitinib|"During the treatment phase of the study, eligible patients will receive varlilumab for up to 8 cycles. Treatment cycles are 6 weeks each with varlilumab administered once every 3 weeks and sunitinib administered daily for 4 weeks followed by a 2 week rest. There is no limit on the number of cycles of sunitinib. Patients may be discontinued from receiving study treatment (sunitinib or varlilumab) based on the results of disease assessments or if experiencing side effects that make study therapy intolerable.
~Phase l Dose: The planned dose of varlilumab will be dependent on the cohort assigned at enrollment. Varlilumab doses are 0.3 mg/kg, 1 mg/kg or 3 mg/kg.
~The Study was terminated prior to initiation of Phase II.
~All patients will receive sunitinib at a dose of 50 mg."
16069591|NCT02386098|Drug|BMS-955176|HIV Maturation Inhibitor
16069592|NCT02386098|Drug|Atazanavir (ATV)|Atazanavir
16069593|NCT02386098|Drug|Ritonavir (RTV)|Ritonavir
16069594|NCT02386098|Drug|Dolutegravir (DTG)|Dolutegravir
16069595|NCT02386098|Drug|Tenofovir (TDF)|Tenofovir
16069596|NCT02386085|Procedure|Osteopathic manipulative treatment (OMT)|OMT will be provided as part of the patient's health care, prior to enrollment in the study. All participants would have received the same intervention (OMT) if they had not enrolled in the study.
16069597|NCT02386072|Drug|mirabegron|oral
16069598|NCT02386072|Drug|antimuscarinic medication|oral
16069599|NCT02386059|Drug|PLACEBO|received normal saline, intravenously
16069600|NCT02386059|Drug|Dexamethasone|4 mg, intravenously, at the start of surgery
16069601|NCT02386059|Drug|Ondansetron|4 mg, intravenously, 15 minutes before the end of surgery.
16069606|NCT02386020|Drug|aloe vera|After SRP, aloe vera gel was delivered subgingivally into periodontal pockets.
16069607|NCT02386020|Drug|placebo gel|After SRP, placebo gel was delivered subgingivally into periodontal pockets.
16069608|NCT02386007|Drug|DW-3101_150mg|
16069609|NCT02386007|Drug|DW-3101_300mg|
16069610|NCT02386007|Drug|DW-3101_600mg|
16069611|NCT02386007|Drug|Placebo|
16069612|NCT02385994|Device|enLighten Laser|enLighten Laser treatment with dual-pulse width and dual-wavelength
16069613|NCT02385981|Device|Stivax|
16069614|NCT02385955|Procedure|Myeloablative double unit cord blood transplantation|Two myeloablative conditioning regimens will be used in this study: (1) total body irradation (TBI, 12Gy), followed by cyclophosphamide (60 mg/kg/day on day -3 and -2) and cytarabine (3 g/m2 every 12 hours on day -5 and -4), or (2) thiotepa (5 mg/kg/day on day -7 and -6), busulfan (3.2 mg/kg/day on day -5, -4, and -3), and fludarabine (50 mg/m2/day on day -5, -4, and -3).
16069615|NCT02385942|Device|Smart phone|"measure the Live assessed wound size and the transmitted Smart phone-based wound size
~determine dressing materials using Smart phone-based tele-consultation"
16069616|NCT02385929|Behavioral|Swallowing therapy & resistance training|"i) Individual instructions in swallowing and mouth opening exercises 3 days per week by occupational therapist throughout radiotherapy, ii) Progressive resistance training twice weekly by physiotherapist, either individually or group based, throughout radiotherapy, iii) Daily home-based swallowing and mouth opening exercises from beginning of treatment until 2 months after end-of-treatment.
~iv) Weekly follow-up phone contacts with occupational therapists from end-of-treatment and 2 months onwards."
16069617|NCT02385916|Other|EstroSense®/MD|A natural product already approved by Health Canada
16069618|NCT02385916|Other|Placebo|Placebo
16069619|NCT02385903|Other|Flammacerium|
16069620|NCT02385903|Other|Standard dressing procedure|
16069621|NCT02385890|Other|Control|Non pulse ingredient bagel
16069622|NCT02385890|Other|Pea flour|Pulse ingredient bagel
16069623|NCT02385890|Other|Pea fibre|Pulse ingredient bagel
16069624|NCT02385890|Other|Pea protein|Pulse ingredient bagel
16069625|NCT02385890|Other|Pea flour + pea protein|Pulse ingredient bagel
16069626|NCT02385890|Other|Pea fibre + pea protein|Pulse ingredient bagel
16069627|NCT02385877|Drug|[18F]4F-MHPG|IV injection of [18F]4F-MHPG
16069628|NCT02385877|Drug|[18F]3F-PHPG|IV injection of [18F]3F-PHPG
16069629|NCT02385851|Drug|CHS-1701|
16069630|NCT02385851|Drug|Pegfilgrastim|
16069631|NCT02385838|Behavioral|5-CNL|The 5-CNL front-of-pack nutrition label is introduced on foodstuffs in a controlled shopping environment
16069632|NCT02385838|Behavioral|MTL|The MTL front-of-pack nutrition label is introduced on foodstuffs in a controlled shopping environment
16069633|NCT02385838|Behavioral|GDA|The GDA front-of-pack nutrition label is introduced on foodstuffs in a controlled shopping environment
16069634|NCT02385838|Behavioral|Tick|The Tick front-of-pack nutrition label is introduced on foodstuffs in a controlled shopping environment
16069635|NCT02385825|Biological|RVEc|The composition of the final drug product, prior to any dilution, is 0.2 mg recombinant ricin toxin A-chain 1-33/44-198 (RVEc) in buffer and 0.2% Alhydrogel® at a final volume of 1 mL per vial.
16069636|NCT02385812|Procedure|Low-dose computed tomography Annual scan x3|Annual scan x3
16069637|NCT02385812|Procedure|Low-dose computed tomography Baseline scan only|Baseline scan only
16069638|NCT02385799|Drug|Sertraline Liquid Placebo|Liquid placebo given in parallel to active medication
16069639|NCT02385799|Drug|Sertraline|Active medication
16069640|NCT02385786|Behavioral|Mindfulness-Based Cognitive Therapy|Eight week course in mindfulness meditation training with elements of cognitive behavioral therapy
16069641|NCT02385773|Dietary Supplement|PTM202|Administration of study nutritional product once per day for 3 days starting immediately after enrollment
16069642|NCT02385773|Dietary Supplement|Enfamil Puramino|Administration of 30 ml of Enfamil Puramino as placebo once per day for 3 days starting immediately after enrollment
16069643|NCT02385760|Drug|CTX-4430|
16069644|NCT02385760|Drug|Placebo|
16069645|NCT02385747|Procedure|hystroscopy|Detailed hysteroscopic examination under general anesthesia Once the cavity entered, a panoramic view of the uterine cavity then systematic; first the fundus, then anterior, posterior and lateral walls of the uterus consecutively, ending by visualization of the uterine -tubal junctions, The thickness, colour, aspect and vasculature of the mucous membrane lining the uterine cavity was observed and recorded. If there is any intrauterine pathology detected; the shape, size and site were estimated.
16069646|NCT02385734|Other|Concentrated Growth Factor Membrane|Concentrated growth factor membrane is produced by the centrifugation of venous blood and platelets are concentrated in a gel layer containing fibrin matrix
16069647|NCT02385734|Procedure|Coronally Advanced Flap|Periodontal plastic surgery technique
16069648|NCT02385708|Drug|2% Chlorohexidine Gluconate Standard of Care|Patients will perform the current standard of care treatment using 2% Chlorohexidine Gluconate Cloths on the abdomen and buttocks prior to colorectal surgery night before surgery and morning of surgery.
16069649|NCT02385708|Drug|2% Chlorohexidine Gluconate Chin to Toe|Patients will perform treatment with 2% Chlorohexidine Gluconate cloths chin to toe night before and morning of surgery then daily post operative until post op day 4 or discharge
16069650|NCT02385695|Procedure|Posterior Dynamic Stabilization|
16069651|NCT02385695|Procedure|Internal Fixation and Fusion|
16069652|NCT02385682|Device|Percutaneous coronary intervention|Percutaneous coronary intervention
16069653|NCT02385682|Device|Percutaneous coronary intervention|Percutaneous coronary intervention
16069654|NCT02385669|Drug|Ipilimumab|Checkpoint blockade inhibitor
16069655|NCT02385669|Biological|6MHP|6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
16069656|NCT02385656|Drug|Modafinil|200mg of modafinil daily for 4 weeks
16069657|NCT02385643|Behavioral|SmartPhone Support System|
16069658|NCT02385630|Other|Standardized 400kcal semi-liquid meal|Used to assess post-prandial gut hormone response pre-operatively and at 10 days, 4 weeks, 6 months and 12 months post-operatively.
16069659|NCT02385617|Drug|Octreotide|Octreotide 100mcg (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating
16069660|NCT02385617|Drug|Placebo|0.9% saline (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating
16069661|NCT02385591|Behavioral|Telephone Support|telephone-based physical activity advice and support delivered by a trained professional facilitator.
16069662|NCT02385591|Behavioral|SMS Support|Telephone-based physical activity advice and support delivered by SMS.
16069663|NCT02385578|Other|an educational intervention|"the first step of the train the trainer plan(TTT) ,which including the diagnosis and operation hand in hand teach by Professor Yano Takeshiin,and the case discussion,and so on"
16069664|NCT02385565|Other|high fat diet|high fat diet as 10 % proteins, 30 % lipids, 60 % carbohydrates
16069665|NCT02385565|Other|normal fat diet|high fat diet as 10 % proteins, 45 % lipids,45 % carbohydrates
16069666|NCT02385552|Behavioral|Feedback|Experienced endoscopists will receive feedbacks from investigators about their own adenoma detection rates.
16069667|NCT02385539|Drug|The impact of 10 independent variables on the likelihood of not developing hypotension after intrathecal injection.|The study will be conducted to assess the impact of a 10 independent variables (dose and combination of Levobupivacaine with Fentanyl or Sufentanil, age, basal systolic blood pressure (SBP), basal mean arterial pressure (MAP), time to lowest spinal SBP, upper limit of sensory block (dermatoma level), time intervals of sensory recovery for two consecutive dermatoma level (two-segment regression), time intervals of sensory recovery to the twelfth thoracic dermatoma (T12 regression), time intervals of sensory recovery to the first sacral dermatoma (S1 regression) and Body Mass Index) on the likelihood of not developing hypotension after intrathecal injection.
16069668|NCT02385526|Device|Vagus Nerve Stimulation Therapy|Stimulation of the left tenth cranial nerve via VNS Therapy
16069669|NCT02385513|Biological|10-valent pneumococcal conjugate vaccine|
16069670|NCT02385500|Drug|Fesoterodine|"For each phase of the study, the participants will receive a total of 84 pills of fesoterodine 4 mg. The study medication will be provided by Pfizer.
~For blinded distribution, each bottle of medications will be labeled with a random number for identification. The participant will indicate in a journal the dose taken each day.
~The study participants will be monitored every 2 weeks with phone calls to assess tolerance or side-effects to the medication."
16069671|NCT02385500|Drug|Placebo|"For each phase of the study, the participants will receive a total of 84 placebo pills. The study medication will be provided by Pfizer.
~For blinded distribution, each bottle of medications will be labeled with a random number for identification. The participant will indicate in a journal the dose taken each day.
~The study participants will be monitored every 2 weeks with phone calls to assess tolerance or side-effects to the medication."
16069672|NCT02385474|Drug|12% SDF|12% silver diamine fluoride solution, of which the capability of arresting dental caries is not sure
16069673|NCT02385474|Drug|38% SDF|38% silver diamine fluoride solution, of which the capability of arresting dental caries is known
16069674|NCT02385461|Drug|Low Molecular Weight Heparins (LMWHs)|
16069675|NCT02385448|Drug|Dienogest|The dienogest group will receive dienogest 2mg daily for 24 months postoperatively
16069676|NCT02385448|Drug|Microgynon|The combined oral contraceptive pills group will be given cyclical Microgynon for 24 months.
16069677|NCT02385435|Drug|Bupivacaine|Caudal Bupivacaine 2 mg/kg single shot
16069678|NCT02385435|Drug|dexmedetomidine 1μg.kg-1|Caudal dexmedetomidine 1μg.kg-1, single shot
16069679|NCT02385435|Drug|dexmedetomidine 2μg.kg-1|Caudal dexmedetomidine 2μg.kg-1, single shot
16069680|NCT02385422|Drug|Carvedilol|Carvedilol is started at a dose of 6.25mg/d, and titrated to a maximum dose of 25mg/d. Doses are increased every 2-3 days until ABPsys is not less than 90 mm Hg and HR is not less than 55 bpm.
16069681|NCT02385422|Drug|Propranolol|Patients receiving propranolol start at a dose of 30 mg/d and the dose will be increased to a maximum dose of 160 mg/d.Doses are increased every 2-3 days until ABPsys is not less than 90 mm Hg and HR is not less than 55 bpm.
16069682|NCT02385396|Dietary Supplement|Inofolic: myo-inositol and folic acid|4000 mg of myo-inositol and 0,4 mg of folic acid for 3 months preceding the ICSI procedure
16069683|NCT02385383|Drug|Iron-III Isomaltoside 1000|Protocol for optimizing preoperative Hb using IV Iron-III Isomaltoside 1000
16069684|NCT02385383|Other|Standard Care|Standard Care in a historical control cohort
16069685|NCT02385370|Drug|MMC|using 0.02 MMC soaked sponged under the conjunctiva for 1 to 3 minutes
16069686|NCT02385370|Drug|MMC|0.1 cc of 0.01% MMC is injected into the tenon.
16069687|NCT02385357|Dietary Supplement|Protein-enriched drink|Participants will drink 330 ml of a protein-enriched drink (6 g/ml of protein) after a high intensity exercise that induce muscle damage (30 min running downhill with a slope of -10º)
16069688|NCT02385344|Device|Medistim device|This registry is intended to document surgical findings, procedural changes, and adverse events occurring prior to discharge
16069689|NCT02385318|Drug|Ingenol Mebutate (Perrigo)|
16069690|NCT02385318|Drug|Ingenol Mebutate (Reference)|
16069691|NCT02385318|Drug|Placebo gel|
16069692|NCT02385305|Device|Pressure support ventilation by anesthesia machine (Apollo, Dräger)|Pressure support ventilation will be applied by anesthesia machine (Apollo, Dräger) with pressure support (PS) of 3, 8, 13 and 18 cmH2O in this order, with slope of 1.0 second and no PEEP. The fraction of inspired oxygen will be titrated to achieve SpO2 over 98%. Five minutes will be allowed to achieve equilibrium at each PS level after which an additional recording of one minute of data will be obtained. Once the Pressure support ventilation is completed at 18 cmH2O, ventilation will be carried out in reverse order of PS; 13, 8 and 3 cmH2O of PS.
16069694|NCT02385279|Device|MiStent|Percutaneous Coronary Intervention
16069695|NCT02385279|Device|XIENCE EES|Percutaneous Coronary Intervention
16069696|NCT02385266|Drug|D-Cycloserine|Pharmaceutical intervention aimed at altering central nervous system function takes place over 4.5 months with daily use of d-Cycloserine.
16069697|NCT02385266|Drug|Placebo (for D-cycloserine)|Lactose filled capsules to mimic DCS 200mg capsules
16069698|NCT02385253|Behavioral|Educational training program|"The educational training program (intervention) consists of four sequential phases:
~Knowledge Acquisition
~Skills Assessment
~Deliberate Practice
~Clinical Proficiency"
16069703|NCT02385227|Other|Exclusive blu™ e-cigarette A2|Magnificent Menthol rechargeable e cigarette
16069704|NCT02385227|Other|Exclusive blu™ e-cigarette A3|Cherry Crush rechargeable e cigarette
16069705|NCT02385227|Other|Dual blu™ e-cigarette and usual brand B1|Classic Tobacco rechargeable e cigarette and a usual brand combustible cigarette
16069706|NCT02385227|Other|Dual blu™ e-cigarette and usual brand B2|Magnificent Menthol rechargeable e cigarette and a usual brand combustible cigarette
16069707|NCT02385227|Other|Dual blu™ e-cigarette and usual brand B3|Cherry Crush rechargeable e cigarette and a usual brand combustible cigarette
16069708|NCT02385227|Other|Nicotine product cessation C|Nicotine cessation
16069709|NCT02385214|Procedure|Wide Local Excision = 1cm Margin|"A wide local excision involves removing an extra safety margin of healthy skin surrounding the original melanoma site to ensure that any remaining scattered melanoma tumour cells are removed that may have been left behind after the first initial biopsy/surgery."
16069710|NCT02385214|Procedure|Wide Local Excision = 2cm Margin|"A wide local excision involves removing an extra safety margin of healthy skin surrounding the original melanoma site to ensure that any remaining scattered melanoma tumour cells are removed that may have been left behind after the first initial biopsy/surgery."
16069711|NCT02385201|Device|Senza|Spinal Cord Stimulation
16069712|NCT02385188|Drug|Imiquimod|topical 5% imiquimod cream 3 times a week for 16 weeks.
16069713|NCT02385188|Drug|paracetamol|
16069714|NCT02385188|Drug|lidocaine in Vaseline ointment|
16069715|NCT02385175|Other|Different objective clinical tests of Eustachian tube function|
16069716|NCT02385175|Other|Different patient-completed questionnaires relating to Eustachian tube dysfunction|
16069717|NCT02385149|Other|whole grain wheat|A twelve week intervention of 98g whole grain wheat in the form of 4 slices of bread (is in total 100g bread) and 2 servings of ready to eat cereals (RTEC, is in total 33.4g RTEC).
16069718|NCT02385149|Other|refined wheat|A twelve week control intervention of refined wheat in the form of 4 slices of bread (is in total 100g bread) and 2 servings of ready to eat cereals (RTEC, is in total 33.4g RTEC).
16069719|NCT02385136|Drug|Temozolomide|
16069720|NCT02385123|Biological|Influenza Virus Vaccine Inactivated|A synthetic vaccine consisting of three inactivated influenza viruses: two different influenza type A strains and one influenza type B strain. Trivalent influenza vaccine is formulated annually, based on influenza strains projected to be prevalent in the upcoming flu season.
16069721|NCT02385110|Drug|Alemtuzumab|"Group 1 and 2 Induction Phase: Alemtuzumab total dose of 1.0 mg/kg subcutaneously or by vein over 4 days (days 1-4) during the 8 week induction phase. Day 1 0.1 mg/kg, Day 2 0.3 mg/kg, Day 3 0.3 mg/kg, Day 4 0.3 mg/kg.
~Group 1 Maintenance Phase: 0.2 mg/kg once every 4 weeks for 6 weeks."
16069722|NCT02385110|Drug|Etoposide|"Induction Phase: 150 mg/m2 given by vein once a week for 8 weeks.
~Maintenance Phase: Participants who have evidence of refractory disease or budding relapse during the maintenance phase may revert back to receiving Etoposide."
16069723|NCT02385110|Drug|Dexamethasone|"Induction Phase: 10 mg/m2 for 1 week followed by Dexamethasone 5 mg/m2 for 2 weeks followed by Dexamethasone 2.5 mg/m2 for 2 weeks followed by Dexamethasone 1.25 mg/m2 for 2 weeks.
~Maintenance Phase: 1.25 mg/m2 by mouth three times a week for 16 weeks."
16069724|NCT02385110|Drug|Methotrexate|Participants with central nervous system involvement receive intrathecal methotrexate 12 mg once a week for 5 weeks during the Induction Phase.
16069725|NCT02385110|Behavioral|Phone Call|If participant responds to study drugs, they will receive a phone call by study staff every 3 - 6 months for up to 5 years after completion of treatment. Each call will last about 5-10 minutes.
16069726|NCT02385110|Drug|Tocilizumab|Induction Phase: Tocilizumab at 4 to 8 mg/kg by vein. Day 1 0.1 mg/kg,Day 2 0.3 mg/kg, Day 3 0.3 mg/kg, Day 4 0.3 mg/kg.
16069727|NCT02385097|Drug|Chloroprocaine HCl 2%|Single Administration (20mL) by Axillary Nerve Route
16069728|NCT02385097|Drug|Ropivacaine 0.75%|Single Administration (20mL) by Axillary Nerve Route
16069729|NCT02385084|Drug|LY2409021|Administered orally
16069730|NCT02385071|Drug|Treatment A|150 milligram (mg) SMV capsule with water under fed conditions.
16069731|NCT02385071|Drug|Treatment B|Treatment B (3*50 mg capsules of SMV (including 50 mini-tablets of 1 mg each) with water under fed conditions.
16069732|NCT02385071|Drug|Treatment C|Treatment C (3*50 mg dispersible SMV tablets dispersed in water under fed conditions).
16069733|NCT02385071|Drug|Treatment D|*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with water or 3*50 mg dispersible SMV tablets dispersed in water under fed conditions.
16069734|NCT02385071|Drug|Treatment E|3*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with water or 3*50 mg dispersible SMV tablets dispersed in water under fasted conditions.
16069735|NCT02385071|Drug|Treatment F|3*50 mg SMV capsules (including 50 mini-tablets of 1 mg each) with yoghurt or 3*50 mg dispersible SMV tablets dispersed in apple juice under fed conditions.
16069736|NCT02385058|Drug|Mebendazole|Mebendazole 600 milligram (mg) tablet orally once starting on Day 1 and 21.
16069737|NCT02385058|Drug|Quinfamide|Quinfamide 200 mg tablet orally once starting on Day 1 and 21.
16069738|NCT02385058|Drug|Placebo|Placebo tablet orally once starting on Day 21.
16069739|NCT02385045|Device|i-scan|i-scan function is located on the head of the Pentax endoscopes
16069740|NCT02385045|Device|narrow band imaging|narrow band imaging function is located on the head of Olympus endoscopes
16069741|NCT02385032|Drug|Ursodiol|
16069742|NCT02385032|Drug|URSO Forte|
16069743|NCT02385019|Biological|Donor regulatory T cell adoptive immunotherapy in chronic graft versus host disease|"Regulatory T cells selected by a sequential 2 step procedure:
~- Negative selection of CD8 and CD19 cells
~- Positive selection of CD25 cells"
16069744|NCT02385006|Biological|Blood sample|
16069775|NCT02384811|Radiation|radiation|"A total dose of 40Gy will be delivered in 20 fractions at 2.0Gy/fraction, 5 fractions per week in 4 weeks.
~The CTV encompassed the bilateral supraclavicular region, all mediastinal lymph nodes, the anastomosis site, and the left gastric and Celiac nodes."
16069776|NCT02384798|Other|noninvasive ventilatory support|noninvasive ventilatory support with 5-minute ramp and positive end expiratory pressure (PEEP) of 5 cm H2O for 30 minutes, then there will be the interval aerobic training on a treadmill added to resistance exercises
16069777|NCT02384798|Other|interval training|interval training
16069745|NCT02384993|Behavioral|Enhanced Physical Activity|This is a 26-week aerobic exercise intervention. The primary mode of training is treadmill walking, with the initial speed and duration calibrated to each participant's baseline aerobic capacity. Participants will train 3-4 days per week with the goal of attaining 150+ minutes of exercise per week by the seventh week. Exercise will be set between 50-60% of maximum heart rate reserve for weeks 1-4, 60-70% for weeks 5-8, and 70-80% for weeks 9-26. Exercise duration will be approximately 15-20 minutes per session during the first week and then increase by 5 minutes each week until a duration of approximately 38-50 minutes per session is reached. Each training session will begin with a 5-minute warm-up and end with a 5-minute recovery period.
16069746|NCT02384980|Device|FES (Gait MyoElectric Stimulator)|Functional Electrical Stimulation (FES) will be tested in a group of peripheral arterial disease patients using the Gait MyoElectric Stimulator. The FES device will be applied to the calf and shin muscles on both of the patients legs.
16069747|NCT02384967|Drug|Darunavir|to assess efficacy of a reduced dose strategy of darunavir to 400 mg/d in HIV-1 infected patients virologically suppressed under a once daily regimen including darunavir 800 mg/d and two nucleoside reverse transcriptase inhibitors (NRTI), to maintain the viral load lower than 50 copies / mL at 48 weeks of treatment.
16069748|NCT02384954|Biological|Rituximab|Intravenous infusion; Patients will receive a 4-week induction cycle consisting of Rituximab given on Day 1, 8, 15, 22. Eligible patients will receive a consolidation treatment consisting of Rituximab given on Day 78, 134, 190, 246.
16069749|NCT02384954|Biological|ALT-803|Intravenous infusion for cohort 1, 2 and 3; subcutaneous injection for cohort 4, 5, 6 and 7; Patients will receive a 4-week induction cycle consisting of ALT-803 given on Day 2, 8, 15, 22 for patients in cohort 1, 2, 3, 4 and Day 1, 8, 15 and 22 for patients in cohort 5, 6, 7. Eligible patients will receive a consolidation treatment consisting of ALT-803 given on Day 78, 134, 190, 246.
16069750|NCT02384941|Drug|Placebo|Placebo once daily, before first meal of the day.
16069751|NCT02384941|Drug|Sotagliflozin|Sotagliflozin once daily, before first meal of the day.
16069752|NCT02384928|Procedure|Shinbaro pharmacopuncture|Pharmacopuncture is a treatment that combines 2 of the most frequented Korean medicine treatment methods - traditional acupuncture and herbal medicine - by injecting herbal medicine extract at acupoints. One Hyeopcheok (Huatuo Jiaji, EX B2) acupoint most relevant to patient symptoms with reference to MRI will be administered Shinbaro pharmacopuncture.
16069753|NCT02384928|Device|Acupuncture|Five acupoints will be needled to about 1cm depth assisted by an acupuncture guide tube with no manual stimulation such as twirling or lifting and thrusting.
16069754|NCT02384928|Drug|Conventional medicine|Conventional drugs will be prescribed in an individually-tailored, pragmatic method with reference to most frequently used treatments in patients with a primary diagnosis of LDH (KCD disease classification: M51, M541) according to Korean Health Insurance Review and Assessment (HIRA) 2011 statistics. The most frequently prescribed conventional drugs for LDH include aceclofenac (Drug class: nonsteroidal antiinflammatoy drugs (NSAIDs)), tramadol hydrochloride (Drug class: Opioids), talniflumate (Drug class: NSAIDs), diclofenac sodium (Drug class: NSAIDs), and loxoprofen sodium (Drug class: NSAIDs).
16069755|NCT02384928|Procedure|Physical therapy|Physical therapy will be prescribed with reference to most frequently used treatments in patients with a primary diagnosis of LDH (KCD disease classification: M51, M541) according to Korean Health Insurance Review and Assessment (HIRA) 2011 statistics.
16069756|NCT02384928|Behavioral|Educational program|Educational program sessions supervised by physicians will be provided once a week for 4 weeks.The education program will inform the patient of the favorable prognosis of LDH, and instructions for everyday activities and self-management. The education program will consist of handbooks handed out to each participant, and weekly reminders and encouragement from the physician.
16069757|NCT02384915|Drug|prilocaine|
16069758|NCT02384915|Drug|mepivacaine|
16069759|NCT02384915|Procedure|Sciatic-femoral Nerve Block|ultrasound-guided 25 ml 2% mepivacaine injection on both femoral and sciatic nerve
16069760|NCT02384915|Procedure|Spinal anesthesia|intrathecal injection of 40 mg hyperbaric prilocaine
16069761|NCT02384915|Device|Sonoplex, Pajunk|
16069762|NCT02384902|Other|low GI|All diets were designed with similar macronutrients content (30% fat, 0.8 g/kg/d protein and remained calorie requirement by carbohydrate). Additionally, we controlled phosphorus, sodium and potassium content of diets for three intervention groups. All dietary menus had less than 1500 mg phosphor and less than 2400 mg sodium and 2000 mg potassium.
16069763|NCT02384902|Other|low GI|All diets were designed with similar macronutrients content (30% fat, 0.8 g/kg/d protein and remained calorie requirement by carbohydrate). Additionally, we controlled phosphorus, sodium and potassium content of diets for three intervention groups. All dietary menus had less than 1500 mg phosphor and less than 2400 mg sodium and 2000 mg potassium.
16069764|NCT02384902|Other|conventional diet|All diets were designed with similar macronutrients content (30% fat, 0.8 g/kg/d protein and remained calorie requirement by carbohydrate). Additionally, we controlled phosphorus, sodium and potassium content of diets for three intervention groups. All dietary menus had less than 1500 mg phosphor and less than 2400 mg sodium and 2000 mg potassium.
16069765|NCT02384889|Drug|Difluoromethylornithine|Active Therapy with DFMO
16069766|NCT02384889|Drug|Placebo|Placebo Comparitor
16069767|NCT02384876|Drug|Ephedrine 30mg/10mL injectable solution, single administration, dose : 0.6, 0.8, 1.0, 1.2 and 1.4 mg/kG|
16069768|NCT02384876|Drug|Ephedrine 30mg/10mL injectable solution, single administration, dose : 0.1 mg/kG.|
16069769|NCT02384850|Drug|Selinexor|Dose Level 1: 40 mg on day 1, 3 and 8 in a two-weeks cycle. Dose Level 2: 60 mg on day 1, 3 and 8 in a two-weeks cycle. Dose Level 3: 80 mg on day 1, 3 and 8 in a two-weeks cycle. Dose Level -1: 20 mg on day 1, 3 and 8 in a two-weeks cycle.
16069770|NCT02384850|Drug|Oxaliplatin|85 mg/m² IV over 2 hours, Day 1 of a two-weeks cycle
16069771|NCT02384850|Drug|5-FU|400 mg/m² IV bolus, Day 1 of a two-weeks cycle 2,400 mg/m² continuous infusion IV, Days 1-3
16069772|NCT02384850|Drug|Folinic Acid|400 mg/m2 IV over 2 hours, Day 1 of a two-weeks cycle
16069773|NCT02384837|Device|EXCEL biodegradable polymer-coated sirolimus-eluting stent|
16069774|NCT02384824|Procedure|Primary Percutaneous Intervention|angiography, manual aspiration thrombectomy and antiplatelet therapy
16069810|NCT02384538|Biological|ABT-981|ABT-981 administered by subcutaneous injection
16069811|NCT02384538|Biological|Placebo for ABT-981|Placebo for ABT-981 administered by subcutaneous injection
16069778|NCT02384785|Device|Transcutaneous Electric Nerve Stimulation|Electric currents: 'Transcutaneous Electric Nerve Stimulation' and Transcranial Direct Current Stimulation will be applied on the back of the patients in parallel to the implanted electrodes. Implanted electrode will measure voltages that generated near the spinal cord tissue.
16069779|NCT02384772|Other|Survey|
16069780|NCT02384759|Drug|aflibercept|
16069781|NCT02384759|Drug|LV5FU2|
16069782|NCT02384746|Drug|Fulvestrant|500 mg intramuscular every 28 days
16069783|NCT02384746|Drug|MLN9708|Subjects will be treated in 3 dose cohorts of MLN9708, at 2.3, 3, and 4 mg orally on days 1, 4, 8, and 11 every 21 days.
16069784|NCT02384733|Radiation|Loco-regional RT|
16069785|NCT02384720|Other|Age: 20-40years|
16069786|NCT02384720|Other|Age: 41-64years|
16069787|NCT02384720|Other|Age: ≥65years|
16069788|NCT02384707|Other|allegic food|"Reintroduction procedure for small doses :
~Administration of the first dose
~Clinical monitoring for 45 minutes
~Administration of the second dose"
16069789|NCT02384707|Other|Placebo|
16069790|NCT02384694|Other|Zumba dance|Twelve weeks, 3 times weekly 1 hour training
16069791|NCT02384681|Other|Exposure to auditory fatigue|12-hour auditory exposure
16069792|NCT02384668|Dietary Supplement|Cholecalciferol|One tablet per day. The duration of the intervention period is between 24-36 months. This is defined by the time of ATD treatment withdrawal, which is scheduled between approximately 12-18(-24) months after randomisation. Vitamin D supplementation will continue 12 months after withdrawal of ATD treatment or until relapse of Graves' Disease if this occurs prior.
16069793|NCT02384668|Dietary Supplement|Placebo|One tablet per day. Placebo tablet identical in appearance to cholecalciferol tablet. Duration and cessation of treatment identical to intervention with cholecalciferol.
16069794|NCT02384655|Drug|Fenugreek seed meal|3x3 capsules of fenugreek seeds per day for 14 days
16069795|NCT02384642|Behavioral|COMPASS|COMPASS (Creating Opportunities through Mentoring, Parental involvement and Safe Spaces) is a program for 10-14 year old girls in Eastern DRC. The program is a structured intervention that is intended to engage adolescent girls, through life skills training and establishing or supporting community-supported safe spaces for girls where they can come and gather among themselves and participate in a structured life-skills curriculum.
16069796|NCT02384642|Behavioral|COMPASS plus parenting|The COMPASS plus parenting intervention is the core COMPASS intervention, plus activities for the parents and caregivers of participants.
16069797|NCT02384629|Device|OCT-guided PCI with AXXESS stent|The AXXESS stent (Biosensors Europe SA, Morges, Switzerland) is a dedicated self-expanding bifurcation stent eluting the sirolimus analog Biolimus A9 emulsed in a biodegradable polymer. It has the advantage to preserve the ostium of both distal branches and allows additional stent implantation in the distal branches for complete lesion coverage, while reducing large stent overlap and eliminating deformation. Optical coherence tomography (OCT), has enabled the evaluation of strut coverage and arterial healing after DES implantation with a superior resolution and delineation over other imaging modalities. With using these superiorities of OCT, there have been many studies assessing the neointimal coverage following various types of DES implantation in various periods.
16069798|NCT02384629|Device|OCT-guided PCI with conventional DES (Biomatrix flex stent)|BioMatrix Flex is abluminal biodegradable polymer DES. Its abluminal coating is absorbed after 6 to 9months and turns the DES into a BMS. It combines the proven safety of a DES with an abluminal biodegradable polymer, the prove efficacy of BA9 and an advanced stent design. Optical coherence tomography (OCT), has enabled the evaluation of strut coverage and arterial healing after DES implantation with a superior resolution and delineation over other imaging modalities. With using these superiorities of OCT, there have been many studies assessing the neointimal coverage following various types of DES implantation in various periods.
16069799|NCT02384629|Device|Angio-guided PCI with AXXESS stent|The AXXESS stent (Biosensors Europe SA, Morges, Switzerland) is a dedicated self-expanding bifurcation stent eluting the sirolimus analog Biolimus A9 emulsed in a biodegradable polymer. It has the advantage to preserve the ostium of both distal branches and allows additional stent implantation in the distal branches for complete lesion coverage, while reducing large stent overlap and eliminating deformation. We use the conventional coronary angiography.
16069800|NCT02384629|Device|Angio-guided PCI with PCI with conventional DES (Biomatrix flex stent)|BioMatrix Flex is abluminal biodegradable polymer DES. Its abluminal coating is absorbed after 6 to 9months and turns the DES into a BMS. It combines the proven safety of a DES with an abluminal biodegradable polymer, the prove efficacy of BA9 and an advanced stent design. We use the conventional coronary angiography.
16069801|NCT02384616|Other|Oxygen|Delivery of high concentration of oxygen at induction, maintenance and extubation of children under general anesthesia.
16069802|NCT02384603|Other|Global postural reeducation|
16069803|NCT02384603|Other|Segmental muscle stretching exercises|
16069804|NCT02384603|Other|Cognitive behavioral therapy|
16069805|NCT02384590|Behavioral|Computerized cognitive behavioral therapy|"The Beating the Blues computerized cognitive behavioral therapy (CCBT) program is eight 50-minute online sessions that teach the participant how to better manage stress using cognitive behavioral therapy techniques. Cognitive behavioral therapy involves helping people change their thoughts and behaviors so they can limit the negative impact stress will have on their mood and pain experience."
16069806|NCT02384577|Drug|Budesonide, Formoterol Fumarate Dihydrate|
16069807|NCT02384564|Device|Ambu King Vision Video Laryngoscope aBlade|At time of tracheal intubation, the subject will be intubated using the Ambu King Vision Video Laryngoscope with the appropriately sized Ambu aBlade System based on manufacturer guidelines and clinical judgement. The first attempt to successful intubation will be assessed. The Cormack Lehane and Percentage of Glottic Opening scores will be recorded via direct vision. Information on subsequent attempts, time to successful intubation, and ease of tracheal tube insertion will be assessed.
16069808|NCT02384564|Device|Direct Laryngoscopy via Miller Straight Blade|At time of tracheal intubation, the subject will be intubated via direct laryngoscopy using a straight laryngoscope blade, based on manufacturer guidelines and clinical judgement. The first attempt to successful intubation will be assessed. The Cormack Lehane and Percentage of Glottic Opening scores will be recorded via direct vision. Information on subsequent attempts, time to successful intubation, and ease of tracheal tube insertion will be assessed.
16069812|NCT02384525|Procedure|Fluid management by the value of over hydration in Bioelectrical impedance|In this study, investigator measure the fluid status of the patients by bioelectrical impedance analysis and lung ultrasound. The patients are assigned into two groups, BIA and Lung Ultrasound based versus clinical-based assessment group. Ultrafiltration of BIA and Lung Ultrasound based group is adjusted to be equal to the value of over hydration measured only by BIA, not by Lung Ultrasound, because Lung Ultrasound cannot determine exact amount of the patient's fluid excess. Total amount of ultrafiltration will be removed from the patient for three days evenly. On the other hand, Ultrafiltration amount will be decided by the physician in the clinical based group. Amount of fluid removal for a day will be adjusted not to exceed 2000ml, so that total fluid removed from the patient will not exceed 6000ml for three days.
16069813|NCT02384525|Procedure|Fluid management by clinical-based ultrafiltration|In this study, investigator measure the fluid status of the patients by bioelectrical impedance analysis and lung ultrasound. The patients are assigned into two groups, BIA and Lung Ultrasound based versus clinical-based assessment group. Ultrafiltration of BIA and Lung Ultrasound based group is adjusted to be equal to the value of over hydration measured only by BIA, not by Lung Ultrasound, because Lung Ultrasound cannot determine exact amount of the patient's fluid excess. Total amount of ultrafiltration will be removed from the patient for three days evenly. On the other hand, Ultrafiltration amount will be decided by the physician in the clinical based group. Amount of fluid removal for a day will be adjusted not to exceed 2000ml, so that total fluid removed from the patient will not exceed 6000ml for three days.
16069814|NCT02384512|Drug|Azilect®|AZILECT® 1mg Tablets
16069815|NCT02384499|Biological|ALLO-ASC injection|Allogenic-adipose-derived mesenchymal stem cells (ALLO-ASC) injection to the anal sphincter of patients with fecal incontinence
16069816|NCT02384499|Drug|Placebo|0.9% normal saline with fibrin glue injection to the anal sphincter of patients with fecal incontinence
16069817|NCT02384486|Behavioral|Training to Reduce Stress in Mothers of Children with (ASD)|The main objective of the proposed study is to examine the effect of implementing the proposed intervention on stress in mothers of children with ASD in SA
16069818|NCT02384486|Other|Nothing (treatment as usual)|Mothers in the control group will continue to receive treatment as usual during the trial
16069819|NCT02384473|Procedure|Real-Time CEUS|Undergo real-time CEUS
16069820|NCT02384473|Procedure|SWE|Undergo SWE
16069821|NCT02384473|Drug|Definity Suspension for Injection|Participant will receive contrast agent by intravenous administration
16069822|NCT02384473|Device|Philips Shear Wave Elastography|Type of equipment used for SWE
16069823|NCT02384460|Drug|SD-101-6.0 cream|applied topically once a day for 90 days
16069824|NCT02384460|Drug|Placebo (SD-101-0.0) cream|applied topically once a day for 90 days
16069825|NCT02384434|Device|Low Level Laser Therapy|Red Light Therapy
16069826|NCT02384421|Device|Adaptive DBS (Activa PC+S Neurostimulator)|
16069827|NCT02384421|Device|Continuous DBS (Activa PC+S Neurostimulator)|
16069828|NCT02384408|Procedure|Endometrial Biopsy|Histological assessment
16069829|NCT02384408|Device|Transvaginal Ultrasound|Endometrial Thickness made by ultrasound
16069830|NCT02384408|Procedure|Endometrial Immunohistochemical|Immunoexpression of estrogen (ER) and progesterone receptors (PR) and Bcl-2 protein
16069831|NCT02384395|Drug|DTG/3TC/ABC FDC|DTG/3TC/ABC FDC as initial therapy for AHI
16069832|NCT02384382|Drug|Enzalutamide|
16069833|NCT02384369|Drug|SNC-102 sustained release tablet|Sustained release oral tablet of SNC-102
16069834|NCT02384343|Drug|Dexmedetomidine|An intravenous bolus of dexmedetomidine 30 mcg (7,5 mL) administered at least five minutes after birth, in participants with shivering grade 3 or 4 on a scale described by Crossley and Mahajan.
16069835|NCT02384343|Drug|Normal saline|An intravenous bolus of normal saline (7,5 mL) administered at least five minutes after birth, in participants with shivering grade 3 or 4 on a scale described by Crossley and Mahajan.
16069836|NCT02384317|Drug|CCX168|BID for 84 days
16069837|NCT02384304|Behavioral|Choice|A self help program consisting of 8 modules and access to therapist guidance either through messages or through chat sessions
16069838|NCT02384304|Behavioral|Messages|A self help program consisting of 8 modules and access to therapist guidance through messages
16069839|NCT02384304|Behavioral|Self help|A self help program consisting of 8 modules
16069840|NCT02384291|Device|Alpha-Bio GRAFT Natural Bovine Bone|Pure Hydroxyapatite ceramic mineral with high similarity to the human bone
16069841|NCT02384291|Device|natural bone substitute|natural bone substitute material derived from the mineral portion of bovine bone
16069842|NCT02384278|Behavioral|Internet-based CBT for alcohol problems|A 12-week internet-based program based on cognitive behavior treatment (CBT) and relapse prevention
16069843|NCT02384265|Behavioral|IM/SMS + Incentive Condition|See description of Intervention arm protocols above.
16069844|NCT02384252|Other|functional tissu atrial analysis|
16069845|NCT02384239|Drug|Palbociclib|
16069846|NCT02384200|Drug|nitrofurantoin monohydrate/macrocrystalline capsules|1 week course of preoperative nitrofurantoin monohydrate/macrocrystalline capsules 100 milligrams twice daily
16069847|NCT02384200|Drug|ampicillin|IV (2 g)
16069848|NCT02384200|Drug|gentamicin|IV (5 mg/kg)
16069849|NCT02384200|Drug|vancomycin|IV (1 g)
16069850|NCT02384200|Drug|ceftriaxone|IV (2 g)
16069851|NCT02384187|Drug|Gabapentin as premedication|Patients will receive 0.3 ml/kg (16 mg/kg) oral gabapentin solution (Neurontin 50 mg/ml, Pfizer Pharmaceutical) as premedication two hours before the induction of anesthesia
16069852|NCT02384187|Drug|placebo|Patients will receive 0.3 ml/kg of a placebo solution identical in taste, shape and color to the study medication two hours before the induction of anesthesia.
16069853|NCT02384174|Dietary Supplement|Resistant starch|
16069854|NCT02384174|Dietary Supplement|Dietary fibre (arabinogalactan, gum guar, pectin)|
16069855|NCT02384161|Other|Isometric exercise Intermittent|Intermittent isometric exercise is characterized by an interval muscle contraction (one period and another relaxed contracted period) in which there is no generation of voltage change in the length of the muscle fiber.
16069856|NCT02384148|Other|Circadian rhythm measurement|
16069857|NCT02384148|Procedure|Skin biopsy|A 2mm diameter skin biopsy is performed by a physician using standard procedure.
16069896|NCT02383810|Drug|Elsiglutide|
16069858|NCT02384135|Other|Three-month thromboembolic risk in patient with D-dimer levels between the usual cut-off and the age-adjusted cut-off|
16069859|NCT02384122|Drug|Octreotide|Two injections of 20 mg will be given monthly.
16069860|NCT02384109|Behavioral|Shared decision-making with pharmacists|Pharmacist will engage patient using Healthwise (TM) Decision Tool to help match their personal preferences and values with treatment options, specifically lifestyle change with a goal of 7% weight loss or metformin. Patients interested in lifestyle change will be referred to a CDC (Center for Disease Control and Prevention)-approved diabetes prevention program, and pharmacists will coordinate with primary care providers to prescribe metformin for patients interested in this treatment.
16069861|NCT02384109|Other|Standard care from primary care providers|Primary care providers address pre-diabetes as part of usual care, which may involve no action, referrals, or treatment with medications.
16069862|NCT02384096|Device|Conventional single source programming|Precision Spectra SCS System using conventional single source programming.
16069863|NCT02384096|Device|Precision Spectra SCS System advanced programming|Precision Spectra SCS System using advanced programming
16069864|NCT02384083|Drug|Filanesib, pomalidomide and dexamethasone|Patients will be treated with 28-day cycles of Filanesib administered iv as a 1-hour (± 10-minute) infusion at escalating doses on days 1, 2, 15 & 16, + pomalidomide administered p.o. at escalating doses during 21 days with 7 days rest period + dexamethasone at a fixed dose of 40 mg po days 1, 8, 15 & 22. G-CSF prophylaxis is mandatory in all patients after Filanesib, starting from Day 3 and Day 17 (for a total of 7 days each). Treatment will be continued until progression or unacceptable toxicity.
16069865|NCT02384070|Procedure|FFR|Fractional flow reserve tracings were calculated using a Volcano pressure wire intra-coronary system after ensuring proper calibration of the aortic pressure transducer and the guidewire, using 6 Fr-guide catheters. Before crossing the stenosis, baseline pressure was measured by the guide catheter and the pressure guidewire were equalized according to the manufacturer's specifications. After advancing the pressure sensor across the stenosis, coronary hyperemia was induced using intravenous adenosine (140μg/kg/min until a steady state was reached for at least 3 minutes). Fractional flow reserve was considered positive if it was less than 0.80.
16069866|NCT02384070|Drug|Aspirin|All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure
16069867|NCT02384070|Drug|Clopidogrel|All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure
16069868|NCT02384070|Drug|Bivalirudin|Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure
16069869|NCT02384057|Other|Computerized cognitive training program|1000 minutes of computerized cognitive rehabilitation with C8 sciences program
16069870|NCT02384057|Other|Conventional cognitive rehabilitation|Same amount of conventional cognitive rehabilitation
16069871|NCT02384044|Device|Crest® Sensi-Stop™ Strips|
16069872|NCT02384044|Device|Colgate® Sensitivity Relief Pen|
16069873|NCT02384031|Device|Traumatic needle|Lumbar puncture is performed with a traumatic needle
16069874|NCT02384031|Device|Atraumatic needle|Lumbar puncture is performed with an atraumatic needle
16069875|NCT02384018|Biological|autologous mesenchymal stromal cell|Islet transplantation patients will receive autologous MSCs following islets infusion
16069876|NCT02384005|Other|Self-anal exam arm|After a short pre-test the clinician will use a model to show a normal and diseased anal canal and then use pictures to show a self-DAE. The clinician will describe how to do a self-DAE for single men and partners. Next, the clinician will ask the participant to lower his pants for collection of anal human papillomavirus (HPV) DNA and cytology. The clinician will conduct a DAE and then participants will do self-DAE done in private. Then the research assistant will demonstrate the computer-assisted self-interview. When participants return to the clinician to receive the DAE results, the clinician will conduct a safety-related interview. The clinician will treat external anal disease, triage internal anal disease, and ask to be notified if a participant has any anus-related concerns in the following week. A complete appointment will require 70 minutes for singles and 105 minutes for couples. The PI will later conduct 3 focus groups.
16069877|NCT02383992|Drug|3% H2O2 solution|
16069878|NCT02383992|Drug|0.9% normal saline|
16069879|NCT02383979|Device|Sham (Comparator) Plasma Ball|"will consist of undergoing a sham therapy with a 22 plasma globe involving contralateral limb interaction with the sphere."
16069880|NCT02383979|Device|Mirror|will undergo 14 days of daily mirror therapy sessions preoperatively which will consist of observing the unaffected limb reflected for 30 minutes in a mirror positioned in the midline to block the view of the affected limb
16069881|NCT02383966|Drug|Cetuximab|Participants received Cetuximab as an intravenous infusion at an initial dose of 400 milligrams per square meter (mg/m^2) on Day 1 and a subsequent dose of 250 mg/m^2 on Day 8 and Day 15 of each 21-day treatment cycle.
16069882|NCT02383966|Drug|Cisplatin/Carboplatin|Cisplatin or Carboplatin (at an equivalent dose in case of intolerability of cisplatin) was administered at a dose of 75 mg/m^2 as an intravenous infusion on Day 1 of each 21-day treatment cycle.
16069883|NCT02383966|Drug|5-fluorouracil|Participants received 5-fluorouracil (FU) at a dose of 750 mg/m^2/day as a continuous intravenous infusion over 24 hours a day from Day 1 to Day 5 of each 21-day treatment cycle.
16069884|NCT02383940|Drug|Sotagliflozin|Sotagliflozin 400 mg, once daily before the first meal of the day
16069885|NCT02383940|Drug|Placebo|Placebo, once daily before the first meal of the day
16069886|NCT02383927|Drug|Tipifarnib|FTase inhibitor
16069887|NCT02383901|Drug|Methotrexate|The study includes osteosarcoma patients who have received MAP treatment, MAP treatment contains 12 courses of Methotrexate
16069888|NCT02383888|Drug|BI 425809|
16069889|NCT02383888|Drug|BI 425809|
16069890|NCT02383888|Drug|Placebo|
16069891|NCT02383888|Drug|BI 425809|
16069892|NCT02383875|Behavioral|Opticourses|An intervention session consisted of five two-hour educative workshops which aimed to help people to improve the nutritional quality of food purchases under budgetary constraints.
16069893|NCT02383862|Other|Feedback Group|The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores
16069894|NCT02383823|Drug|Estrogens|Crossover study of estrogen or placebo in random order in menopausal women
16069895|NCT02383823|Other|Placebo|Crossover study of placebo or estrogen in random order in menopausal women
16069898|NCT02383797|Biological|Varilrix|Vaccination against varicella in selected cartilage-hair hypoplasia patients
16069899|NCT02383784|Dietary Supplement|Low GI index diet|Low glycemic index diet
16069900|NCT02383784|Dietary Supplement|High GI diet|High glycemic index diet
16069901|NCT02383771|Drug|Ticagrelor|(Ticagrelor 90mg Bid) x 7days
16069902|NCT02383771|Drug|Aspirin + Ticagrelor|(Aspirin 100mg daily + Ticagrelor 90mg Bid) x 7days
16069903|NCT02383771|Drug|Control|No Anti-platelet Therapy
16069904|NCT02383771|Drug|Aspirin + Ticagrelor|Dual anti-platelet therapy (Aspirin 100mg daily + Ticagrelor 90mg Bid) after percutaneous coronary intervention (PCI)
16069905|NCT02383758|Drug|Glycerin Suppository|Nursing staff will administer one glycerin suppository in the bathroom if there is no continent bowl movement in the first 30 minutes. Subjects will be taken to the bathroom 5 minutes after the suppository is administered for a 30 minute sit or until a continent void occurs. If continent bowel movements maintain on two subsequent days (after bisacodyl suppositories are discontinued) the glycerin suppository will be discontinued. At least one primary caregiver will be trained on all components of intervention still in use on the last day their child's admission. Four weekly follow-up appointments will be used to support them as they continue to implement the protocol at home, including continuing to fade out the use of medications for participants who are at least partially continent but not fully independent at the time of discharge.
16069906|NCT02383758|Drug|Bisacodyl suppository|If a subject does not have a bowel movement during the 30 minute sit following administration of the glycerin suppository, they will be given a 1 hour break, after which a bisacodyl suppository will be administered. The participant will then sit for an additional 30 minutes.If continent bowel movements maintain for two subsequent days (after senna is discontinued) bisacodyl suppositories will be discontinued if it was required. At least one primary caregiver will be trained on all components of intervention still in use on the last day their child's admission. Four weekly follow-up appointments will be used to support them as they continue to implement the protocol at home, including continuing to fade out the use of medications for participants who are at least partially continent but not fully independent at the time of discharge.
16069907|NCT02383758|Drug|Senna|If no continent bowel movements occur for two consecutive treatment days, caregivers will be asked to administer senna each evening thereafter until medication tapering begins. Once there have been two successive days with continent bowel movements, senna will be removed from the intervention if it was required.
16069908|NCT02383745|Other|Acute EEG with fast EEG electrode|
16069909|NCT02383732|Behavioral|Universal Safety Measures Module (All participants)|During the first session, the therapist conducts a home safety evaluation. During the second visit the therapist provides the caregiver with an individualized Elopement Prevention & Safety Plan (EPSP) based upon the results of the evaluation. The remainder of the session is spent helping caregivers make plans to implement the EPSP to reduce the risk of elopement or lessen the risk of harm to the child if they do successfully elope.
16069910|NCT02383732|Behavioral|Proximity Training Module (Bolting Prevention Participants)|During the first session a functional behavioral assessment (FBA) of bolting is conducted to identify the motivator(s) that evoke bolting. Caregivers identify a setting that is most problematic because it contains the item/activity that most frequently serves as a motivator for elopement. In the next session, caregivers are taught to identify effective alternative reinforcers. In subsequent sessions, antecedent and consequence based strategies are employed to reduce motivation for elopement and reinforce remaining within the designated proximity of a caregiver for increasing durations.
16069911|NCT02383732|Behavioral|Check-In Training Module (Wandering Prevention Participants)|This module employs behavioral strategies to teach a child to check in with a caregiver at frequent fixed intervals during periods of low supervision. Delivering potent reinforcement for checking in counteracts any motivation to wander. Furthermore, if the child does wander caregivers become aware of it immediately because they failed to check in. During the first session caregivers are taught to identify effective reinforcers. A vibrating alarm that can be carried in a participating child's pocket serves as a prompt to seek out a caregiver and check-in. Participants receive access to a previously identified and individualized reinforcer for checking-in with the caregiver.
16069912|NCT02383719|Device|Oro-nasal Mask|
16069913|NCT02383706|Device|ApneaLink Air|Overnight, home polysomnography device
16069914|NCT02383706|Behavioral|Berlin Quesionnaire|OSA screening questionnaire
16069915|NCT02383706|Behavioral|Epworth Sleepiness Scale|OSA screening questionnaire
16069916|NCT02383706|Behavioral|STOP-BANG questionnaire|OSA screening questionnaire
16069917|NCT02383706|Other|Physical exam|Physical exam of neck, mouth and upper airway
16069918|NCT02383693|Device|Repetitive Transcranial Magnetic Stimulation|Repetitive Transcranial Magnetic Stimulation
16069919|NCT02383680|Biological|Yellow Fever Vaccination|The Yellow Fever vaccination is actually not part of the study. Only individuals who have an indication for yellow fever vaccination according to Swiss vaccination recommendations will be enrolled. Study procedures will include blood collection to measure antibody development and viremia as well as data collection on possible side effects.
16069920|NCT02383667|Device|Electrocardiogram holter|
16069921|NCT02383654|Procedure|Autologous Adipose-Tissue Derived Stem Cells|"Intravenous and Intracerebral implantation of Autologous Adipose-Tissue Derived Stem Cells
~Patient will receive brain implantation of approximately 100 -400million Autologous Adipose-Tissue Derived Stem Cells.
~Patient will receive Intravenous of approximately 100-400 million Autologous Adipose-Tissue Derived Stem Cells twice , before brain implantation, and will receive Intravenous of approximately 100-400 million Autologous Adipose-Tissue Derived Stem Cells twice, after brain implantation ."
16069922|NCT02383615|Procedure|Saphenous nerve block|Ultrasound guided saphenous nerve blocks with 0.5% Ropivacaine for patients undergoing elective foot and ankle surgery for post-operative pain relief.
16069923|NCT02383589|Drug|Mycophenolate Mofetil Placebo|MMF matching placebo will be administered orally Q12H.
16069924|NCT02383589|Drug|Mycophenolate Mofetil|MMF will be administered at a starting dose of 500 milligrams (mg) Q12H and the dose will be titrated to achieve a goal of 1 gram (gm) Q12H.
16069925|NCT02383589|Drug|Rituximab|Rituximab will be administered at a dose of 1000 mg via IV infusion.
16069926|NCT02383589|Drug|Rituximab Placebo|Rituximab matching placebo will be administered via IV infusion.
16069927|NCT02383576|Other|No Intervention|No intervention administered in this study.
16069928|NCT02383563|Drug|metformin extended release|
16069929|NCT02383550|Other|Observational Cognitive assessments|Observational
16069930|NCT02383537|Other|Diabetes|the trial is observational with no intervention
16069931|NCT02383524|Procedure|Lumbar Radiofrequency Medial Branch Neurolysis|Numerous studies have concluded that facet joint pain can be accurately diagnosed if a significant (but temporary) reduction in pain is achieved with a procedure called a Medial Branch Block (MBB). The clinician delivers a targeted injection of local anesthetic to the joint itself, or in close proximity to the medial branch of the posterior rami of the dorsal root. A significant decrease in pain confirms that the pain originates from the facet joint. If or when the pain returns after successful MBB treatment the patient may be considered for radiofrequency denervation (neurotomy) which selectively disrupts the joint's nerve supply and provides longer-term sustained relief
16069932|NCT02383511|Drug|SMT C1100|Period 1, SMT C1100 1250 mg BID; Period 2, Placebo BID; Period 3, SMT C1100 2500 mg BID
16069933|NCT02383511|Drug|SMT C1100|Period 1, SMT C1100 1250 mg BID; Period 2, SMT C1100 2500 mg BID; Period 3, Placebo BID
16069934|NCT02383511|Drug|SMT C1100|Period 1, Placebo BID; Period 2, SMT C1100 1250 mg BID; Period 3, SMT C1100 2500 mg BID
16069935|NCT02383498|Other|GI-6301 Placebo|GI-6301 Placebo will consist of USP-grade or equivalent 0.9% Sodium Chloride for Injection. Doses of GI-6301 placebo will be drawn into labeled syringes by an independent, unblinded pharmacist or designee.
16069936|NCT02383498|Biological|GI-6301 Vaccine (Yeast- Brachyury)|GI-6301 Vaccine is a heat-killed, recombinant yeast-based vaccine engineered to express the transcription factor, Brachyury. The Brachyury gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wildtype yeast) to produce the final recombinant vaccine product.
16069937|NCT02383498|Radiation|Radiotherapy|Standard of care
16069938|NCT02383498|Device|wGT3X-BT Actigraph|wGT3X-BT is small, non-invasive, portable watch accelerometer worn on the subject's wrist for Cycle 1 through Cycle 9
16069939|NCT02383485|Behavioral|Exercise|Heart rate monitors worn by each child at each session
16069940|NCT02383485|Behavioral|After-school program|Supervised recreational program with token economy
16069941|NCT02383472|Device|MedX Health Console model 1100|"All treatments will be administered using the MedX Health Console model 1100. These units were cleared by the FDA as non-significant risk in 2003 and approved for home treatment use in 2005 for temporary increase in local blood flow circulation . . . for temporary relief of minor muscle and joint aches. Cluster heads are 2 inches in diameter. Each contains 9 red (633nm wavelength) diodes and 52 near infrared (870 nm wavelength) diodes. LED cluster heads would be applied to the frontal, parietal and temporal areas, as well as the mid sagittal suture line"
16069942|NCT02383472|Device|MedX Health Console model 1100-placebo|The placebo machine is identical in appearance as the treatment machine; It vibrates, warms, and does everything the treatment machine does except it does not have LED lights on the marker, therefore it cannot emit light. Subjects enrolled in the placebo group will be on the same schedule as the treatment group. They will have two, 10 minute treatments, three times a week totaling 18 visits. The placebo allows the researchers to isolate the effect of the study treatment. If patient's in the LED treatment group fare significantly better than those in the placebo treatment group, the study helps support the conclusion that the LED therapy is effective.
16069943|NCT02383446|Device|Elan foot prosthesis|The research group will perform a gait analysis test (on a computerized treadmill) using their own non-computerized hydraulic foot, while in-socket pressures are measured. The prosthetic foot will then be replaced by a computerized prosthetic foot for one month, following which, the measurements will be repeated. Gait factors will be examined (spatio-temporal data, center of pressure movement) and internal loads inside the residuum will be evaluated. Comparison will also include patient's satisfaction and his ability to move around, evaluated by dedicated questionnaire.
16069944|NCT02383433|Drug|Regorafenib|Given PO
16069945|NCT02383433|Drug|Gemcitabine Hydrochloride|Given IV
16069946|NCT02383420|Radiation|Radiation|Live subjects will receive two x-rays, one with predicate detector and one using the GOS or CsI investigational detector. Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detector.
16069947|NCT02383407|Device|Medtronic Deep Brain Stimulation|
16069948|NCT02383394|Other|follow up antenatal care|ultrasound follow up of pregnancy
16069949|NCT02383381|Procedure|lateral rectus recession|typical surgery for correcting intermittent exotropia
16069950|NCT02383368|Drug|ASP4132|oral
16069951|NCT02383355|Drug|Raltegravir|Raltegravir 400mg tablets administered twice daily together with continuation of their own backbone therapy
16069952|NCT02383355|Drug|Continuation of own regimen|Continuation of own antiretroviral medication during the 10 weeks follow-up
16069953|NCT02383329|Dietary Supplement|The ONS provided to the children intervention group will be a ready to drink age adapted oral nutrition supplement providing 1,5 kcal/ml|The ONS provided to the children intervention group will be a ready to drink age adapted oral nutrition supplement providing 1,5 kcal/ml
16069954|NCT02383316|Other|Oral Glucose tolerance test|Oral glucose tolerance test (OGTT): glucose and insulin levels will be measured at time points 0, 90 and 120 min or 30, 60, 90 and 120 after 1.75 g/Kg (max 75 g) glucose administration depending of the patient weight.
16069955|NCT02383303|Behavioral|Individual Development Account and financial education|The Program intervention includes a matched savings account (Individual Development Account) and financial education.
16069956|NCT02383290|Other|Decision support|Saliva samples will be collected from each participant for genetic testing. A genetic report will be fed back to the research server, and into the Family Physicians/pharmacist's electronic record. The electronic record is linked to the UBC TreatGx computer; the next time the participant is seen by the Family Physician / Pharmacist personalized prescribing recommendations will be available for use.
16069957|NCT02383277|Other|Stretching|Stretching of the rib cage muscles
16069958|NCT02383277|Other|Control|Rest without stretching (sham)
16069959|NCT02383277|Other|Exercise|Constant load exercise on a bike
16069960|NCT02383251|Drug|Pazopanib|Pazopanib 600mg during the fist cycle. Then, if there is not heptic triuyble, the dose could be increased to 800mg
16069961|NCT02383251|Drug|Paclitaxel|Arm 1 : Paclitaxel 65mg/m² Arm 2: Paclitaxel 80mg/m²
16069962|NCT02383238|Drug|Dapagliflozin|10 mg, oral for 6 weeks
16069963|NCT02383238|Drug|Placebo|oral for 6 weeks
16069964|NCT02383225|Behavioral|Lakota Language enhancement|This intervention component includes more extensive adaptation for Lakota families, focusing on use of Lakota language specifically around relationship/kinship terms. Study arms without this component will include the same adapted intervention but with use of English language rather than Lakota.
16069965|NCT02383225|Behavioral|Facebook Supplement|This intervention component includes a social media supplement to engage families outside of weekly intervention sessions and will include postings and polls for participating parents/other caregivers to complete between sessions.
16069966|NCT02383225|Behavioral|Substance Use Resistance Skills|This intervention component consists of the original substance use resistance skills training from the Iowa Strengthening Families Program for Parents and Youth 10-14; arms without this component will include a session on healthy eating and exercise (attention control).
16069967|NCT02383212|Drug|Cemiplimab|
16069968|NCT02383212|Radiation|Hypofractionated radiotherapy|
16069969|NCT02383212|Drug|Cyclophosphamide|
16069970|NCT02383212|Drug|Docetaxel|
16069971|NCT02383212|Drug|Carboplatin|
16069972|NCT02383212|Drug|GM-CSF|
16069973|NCT02383212|Drug|Paclitaxel|
16069974|NCT02383212|Drug|Pemetrexed|
16069975|NCT02383186|Procedure|Dermal Suturing Only Wound Closure|The side assigned to dermal suturing only will be closed with a single layer of deep absorbable sutures. The method will be buried vertical mattress or set-back suturing at the surgeons discretion.
16069976|NCT02383186|Procedure|Layered Cutaneous Wound Closure|The side assigned to layered closure is closed with 5-0 fast acting gut.
16069977|NCT02383173|Other|Basic Implementation Approach|Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams, using a Basic Implementation Approach with a teleconference to review educational materials and activate PCCTs to educate other providers.
16069978|NCT02383173|Other|Enhanced Implementation Approach|"Comfort Care Education Intervention utilizing the established infrastructure of Palliative Care Consult Teams, using an Enhanced Implementation Approach with in-person, train-the-champion workshops to prepare PCCT members to be leaders and trainers at their home sites"
16069979|NCT02383160|Device|Bioventus Exogen 4000: Low-intensity pulsed ultrasound|Active low-intensity pulsed ultrasound
16069980|NCT02383160|Device|Sham device|Placebo device with no active therapy
16069981|NCT02383147|Device|Tomographic Neurofeedback|EEG-Electrodes are placed on the patients head to record the brain activity, EEG-recordings are processed by the standardized Low Resolution Brain Electromagnetic Tomography algorithm (sLORETA) to calculate the frequency spectrum in the auditory cortex and deliver feedback for the patient
16069982|NCT02383147|Device|Non Tomographic Neurofeedback|EEG-electrodes are placed on the patients head, but only 4 electrodes (Fc1, Fc2, F3 and F4 of a 10-10 EEG-system) record the surface activity and generate the feedback for the patient.
16069983|NCT02383121|Drug|Midodrine|Not appliciable
16069984|NCT02383108|Drug|DTG +DRV/r|NRTI-sparing regimen: Once daily integrase inhibitor (INSTI) + darunavir/ritonavir (DRV/r)
16069985|NCT02383108|Drug|SOC|Standard of care (continuing triple anti-retroviral therapy including 2 NRTIs + boosted PI/NNRTI)
16069986|NCT02383095|Behavioral|Art therapy|
16069987|NCT02383095|Behavioral|metacognitive therapy|
16069988|NCT02383069|Other|Intervention Group|Aerobic training
16069989|NCT02383069|Other|Control Group|Chest physiotherapy: Flutter and muscle stretching
16069990|NCT02383056|Device|Omnilux|Photomodulation irradiated with a 633 +/- 3 mm light source for 20 minutes (105 mW/cm, 126 J/cm)
16069991|NCT02383056|Device|Omnilux Sham|Sham light instead of phototherapy from the same light device
16069992|NCT02383043|Drug|Cocaine|
16069993|NCT02383043|Drug|Sustained Release d-Amphetamine|
16069994|NCT02383030|Drug|Fulvestrant|After randomization patients will receive (Arm A, experimental Arm) fulvestrant as the following schedule: 500 mg i.m. on Days 0, 14, 28 followed by fulvestrant 500 mg im given every 28 days until progression disease. Study will start after 42 days from the last cycle of chemotherapy
16069995|NCT02383017|Dietary Supplement|Shroom Tech Sport|STS will be given every day in accordance to company guidelines for 12 weeks.
16069996|NCT02383017|Dietary Supplement|Placebo|Placebo will be given in the same fashion as the STS pills guidelines for 12 weeks.
16069997|NCT02383004|Other|Acupuncture|If the child is to receive acupuncture, the sites will be cleaned with an alcohol wipe and acupuncture will be performed using a Seirin pionex press needles. A needle will be placed in the Shen Men points of each ear. Needles will also be placed at the left and right Heart 7 (HT-7) point. This acupuncture point is located on the ulnar side of the anterior carpal region, on the palmer crease of the wrist and radial to pisiform bone. The needles will be inserted bilaterally to a depth of 1.8 mm. Needles will not be inserted at a site of active infection or skin breakdown. Needles will remain for the duration of the operation. The needles will be removed before leaving the operating room.
16069998|NCT02382991|Device|3C60-NMPK|3 months with 3C60 - 10 days wash out - 1 month with NMPK
16069999|NCT02382991|Device|NMPK-3C60|1 month with NMPK - 3 months with 3C60
16070000|NCT02382978|Other|nurse-provided well child visit|
16070001|NCT02382965|Device|transcranial focused ultrasound|
16070002|NCT02382952|Device|Differential Dissector|
16070003|NCT02382952|Other|Standard Dissection Method|
16070004|NCT02382939|Drug|somapacitan|Administered subcutaneously (s.c., under the skin) with an investigational pen once weekly for a 26 week period (8 weeks' dose titration, 18 weeks' fixed dose treatment) followed by 1 week washout.
16070005|NCT02382939|Drug|somatropin|Administered subcutaneously (s.c., under the skin) with a prefilled pen (Norditropin® FlexPro®) daily for a 26 week period (8 weeks' dose titration, 18 weeks' fixed dose treatment) followed by 1 week washout.
16070006|NCT02382926|Other|Capacitive ECG and contactless heart and breathing rate measurements via camera|During a 30 minute driving simulation cardiologic patients in rehabilitation undergo capacitive ECG measurements via sensors in the car seat as well as heart and breathing rate measurements via camera according to the Eulerian Magnification Method.
16070040|NCT02382614|Device|Spiration Valve System|
16070041|NCT02382601|Radiation|Ultrasound|With 3-D and 4-D high-resolution color Doppler methods it is possible to map out the placental circulation, fetal circulation, fetal brain, and fetal cardiac function. Investigators will collect these data points prenatally.
16070007|NCT02382913|Biological|aP booster|"Acellular pertussis vaccine:
~Acellular pertussis (aP) vaccine was administered with different antigen doses intramuscularly in the upper deltoid region of the subject's non-dominant arm.
~Biological: Diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany) To ensure all subjects receive a tetanus and diphtheria booster vaccination, an injection was administered on Study Day 30, one month after the administration of the investigational vaccine."
16070008|NCT02382913|Biological|TdaP booster|"Tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed) Tetanus, reduced diphtheria, and acellular pertussis (TdaP) vaccine was administered with different antigen doses intramuscularly in the upper deltoid region of the subject's non-dominant arm.
~Other: Saline solution Subjects received one injection of saline solution at one month after vaccination."
16070009|NCT02382913|Biological|Licensed TdaP booster (Boostrix®)|"Licensed TdaP booster vaccine Licenced TdaP booster vaccine was administered intramuscularly in the upper deltoid region of the subject's non-dominant arm.
~Other: Saline solution Subjects received one injection of saline solution at one month after vaccination."
16070010|NCT02382900|Biological|quadrivalent human papillomavirus (types 6, 11, 16,18) recombinant vaccine|dose scheme (0 and 6 month)
16070011|NCT02382887|Procedure|tracheal intubation|tracheal intubation with the Airtraq
16070012|NCT02382887|Device|Airtraq|
16070013|NCT02382887|Device|fiberscope|
16070014|NCT02382874|Biological|Intravenous injection|Intravenous injection of AD-MSC to the patients with FSGS
16070015|NCT02382861|Device|Neurally adjusted ventilatory assist|In the NAVA group, the level of NAVA is daily adjusted to obtain Eadimax corresponding to 60 % of Eadimax of the patient during the SBT to obtain a good clinical and biologic tolerance, with a respiratory frequency between 15 and 30/min and a tidal volume at 6ml/kg.
16070016|NCT02382861|Device|Noninvasive pressure support ventilation|In the control group, the PSV is decreased of 2cmH2O daily or several times a day to obtain a good clinical and biologic tolerance, with a respiratory frequency between 15 and 30/min and a tidal volume at 6ml/kg.
16070017|NCT02382848|Drug|Prazosin|A starting dose of Prazosin (1mg capsule) will be given at Week # 1 of this arm. Symptoms will be reassessed and medication will be adjusted by 1-2 mg increments every 7 days for 3 weeks based on clinical response and severity of night mares, to achieve maximum therapeutic benefit while monitoring adverse effects using side effects scale on weekly basis (psychiatrist will be using the scale at every visit). The end point for capping the Prazosin dose will be 6 mg daily.
16070018|NCT02382848|Drug|Placebo|Prazosin-matched placebo pill
16070019|NCT02382848|Drug|Prazosin|A starting dose of Prazosin (1mg capsule) will be given at Week # 5 of this arm. Symptoms will be reassessed and medication will be adjusted by 1-2 mg increments every 7 days for 3 weeks based on clinical response and severity of night mares, to achieve maximum therapeutic benefit while monitoring adverse effects using side effects scale on weekly basis (psychiatrist will be using the scale at every visit). The end point for capping the Prazosin dose will be 6 mg daily.
16070020|NCT02382848|Drug|Placebo|Prazosin-matched placebo pill
16070021|NCT02382822|Other|No intervention.|
16070022|NCT02382809|Drug|DC071|Mouthwash, twice daily
16070023|NCT02382809|Drug|Placebo|Mouthwash, twice daily
16070024|NCT02382796|Drug|Dacomitinib|Starting at the current dose level in the prior study. Dose reductions and re-escalations are allowed based on tolerability. Patients may continue to be treated with dacomitinib on this protocol as long as there is evidence of clinical benefit in the judgment of the investigator.
16070025|NCT02382783|Other|FLARE Intervention Group|"Everything being completed in this group is also being completed in the Standard of Care (SOC) Group except for the following...
~The participants randomized to this group will be asked to complete FLARE Questionnaires on a monthly basis and will call us each month with their results. The last question on the questionnaire asks if the patient feels he/she is having a flare. If the patient says yes to this question, then the study coordinator will arrange for an appointment to be scheduled with a rheumatology health care provider at Mayo Clinic Rochester. The goal will be to have this appointment take place within seven days of the FLARE Questionnaire results being reported."
16070026|NCT02382770|Procedure|Open abdomen procedure|Patients who may need at the end of surgical procedure will be left with open abdomen dressed with different devices or dressing according to the institutional indications.
16070027|NCT02382757|Drug|insulin human|Children will receive conventional treatment with human insulin according to standard medical practice.
16070028|NCT02382744|Device|Ultrasound Guidance|Ultrasound guidance will be used to place a saphenous nerve block
16070029|NCT02382744|Device|Ultrasound guidance + nerve stimulation|Ultrasound guidance and nerve stimulation will be used to place a saphenous nerve block
16070030|NCT02382731|Behavioral|Usual care + letters|A series of five postal educational reminders sent on behalf of each hospital's interventional cardiology team to the patient approximately 4, 8, 20, 32, and 44 weeks post-MI procedure, with an insert for the family physician and pharmacist at approximately 4 and 8 weeks post-MI procedure.
16070031|NCT02382731|Behavioral|Usual care + letters + automated calls|A series of five postal educational reminders as per the usual care + letters arm plus interactive voice response phone calls to the patient delivered approximately 2 weeks after the letters, as well as personalized telephone follow up by trained lay health workers for patients identified by the interactive voice response system as non-adherent. The automated algorithm is designed to identify patients who are non-adherent and who may benefit from personalized educational phone call and/or system navigation support by the lay health worker. Lay health workers will not provide clinical advice.
16070032|NCT02382718|Biological|FAST fish mCyp c 1|Subcutaneous immunotherapy
16070033|NCT02382718|Biological|Placebo|Subcutaneous immunotherapy
16070034|NCT02382679|Dietary Supplement|Experimental: Vitamin Mixture|Vitamins: B2 (riboflavin), magnesium, co-enzyme Q10, Omega 3 fatty acids
16070035|NCT02382679|Dietary Supplement|Placebo|Non-nutritional non-immunogenic non-allergic oil-based capsule with same appearance, weight and density of active experimental vitamin.
16070036|NCT02382666|Drug|Rolapitant|
16070037|NCT02382653|Drug|oral perixicam|Oral adminstration of buccal perixicam
16070038|NCT02382640|Drug|Febuxostat XR|Febuxostat extended-release (XR) capsules
16070039|NCT02382640|Drug|Maalox Advance Regular Strength liquid|Maalox Advance Regular Strength liquid containing Aluminum Hydroxide 200 mg, Magnesium Hydroxide 200 mg, and Simethicone 20 mg/5 mL or equivalent
16070042|NCT02382601|Radiation|MRI|Similar to the Ultrasound data, investigators will collect MRI images of the fetal brain and the placenta. MRI will allow investigators to collect more detailed images of both the fetal brain and placenta, and investigators will be utilizing this technique both prenatally and postnatally.
16070043|NCT02382601|Procedure|Blood collection|The maternal and cord blood will be collected for the processing of plasma and serum. There may be early biomarkers of IUGR in the maternal circulation that investigators can use to better determine the appropriate strategy for clinical management of care. Collection and subsequent analysis of molecular markers in the umbilical cord blood will be used to further confirm physiological dysfunction as detected by ultrasound and MRI techniques.
16070044|NCT02382601|Behavioral|Neurological Function Assessment|Neurological development tests called a Bayley exam and Pediatric Stroke Outcome Measure (PSOM) will be performed.
16070045|NCT02382601|Procedure|Placental Analysis|Placentas will undergo pathological evaluation for placental function.
16070046|NCT02382601|Procedure|Measurement of body fat|The baby's body fat will be measured in a special incubator called a PEAPOD or BODPOD when an infant.
16070047|NCT02382588|Drug|gancyclovir gel|0.15% gancyclovir gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days or until the healing of the dendrite, whichever is earlier.
16070048|NCT02382588|Drug|Hypromellose gel|0.3% hypromellose gel to be applied in the affected eye 5 times per day for a week, followed by 3 times per day for an additional 7 days.
16070049|NCT02382575|Drug|Rituximab|Two to four rituximab infusions (over 2-4 weeks) will be administered once every week at standard dose (Intravenous infusion of rituximab 375mg/mt2)depending on circulating B cells level.
16070050|NCT02382575|Drug|Tacrolimus|Standard dose with oral Tacrolimus 0.2 mg/kg/day in two divided doses till 6 month of relapse free survival.
16070051|NCT02382562|Behavioral|Brief Behavioral Activation Intervention|Clinical psychologists (investigators) will instruct the participant in ways to become more active in life, particularly with regards to activities that the participant finds pleasurable and meaningful. The intervention will take one hour to complete. Following the intervention, the participant will receive brief, weekly text or email reminders for the next 4 weeks (total of 4) to engage in pleasurable and meaningful activities during the week.
16070052|NCT02382549|Drug|dabrafenib|Braf inhibitor
16070053|NCT02382549|Biological|6MHP|6 melanoma helper vaccine comprised of 6 class II MHC-restricted helper peptides
16070054|NCT02382549|Drug|Trametinib|MEK1 AND MEK2 inhibitor
16070055|NCT02382536|Device|BD Scarlett Infusion set|Each subject will receive subcutaneous infusion from two investigational BD Scarlet infusion sets simultaneously, using a commercially available insulin pump to deliver insulin diluent (placebo) into the abdomen. Each infusion will run for approximately 4 1/2 hours.
16070056|NCT02382536|Device|Medtronic QuickSet Infusion Set|Each subject will receive subcutaneous infusion from two Medtronic infusion sets simultaneously, using a commercially available insulin pump to deliver insulin diluent (placebo) into the abdomen. Each infusion will run for approximately 4 1/2 hours.
16070057|NCT02382523|Drug|Acthar 80 unit injection|"Subjects not responding after 3 months of therapy (increasing creatinine; proteinuria not lower by 30%), will continue therapy at a dose 120 U SC x2/wk. Treatment will be discontinued if improvement is not observed 6 months after initiation of therapy.
~If partial remission is achieved with Acthar 80 U SC x2/wk or x3/wk then Acthar will be increased to 120 U SCx2/wk; if remission is achieved, treatment will be continued at this dose for a total of 12 months; otherwise, if response is not observed after 3 months of treatment with the higher dose, we will resume therapy with the original dose/schedule. We will check anti-ACTH antibodies in non-responders.
~If relapse occurs during the follow-up period, a 6 month treatment with Acthar at 120 U SC x2/wk will be started (not for partial responders), and the response will be assessed."
16070058|NCT02382510|Drug|TRN-157|
16070059|NCT02382510|Other|Placebo|
16070060|NCT02382510|Drug|Tiotropium|
16070061|NCT02382497|Device|AN Active tDCS|"The tDCS active stimulations will be directed to PFC regions for six weeks delivered for three times a week.
~tDCS will be delivered by a battery driven, constant current stimulator through a pair of saline-soaked sponge electrodes kept firm by elastic bands.
~The anode will be placed on the left PFC, F3 position according to the 10-20 international EEG system for electrode placement, while the cathode will be placed on the right PFC, F4 position according to the 10-20 international EEG system for electrode placement.
~Stimulation intensity will be set at 1 milliampere (mA), the duration of stimulation will be 20 min."
16070062|NCT02382497|Device|AN Sham tDCS|The same electrode placement will be used as in the stimulation conditions (left anodal/right cathodal), but the current will be applied for 30 s and will be ramped down without the participants awareness, and will be held three times a week for six weeks.
16070063|NCT02382497|Device|BED Active tDCS|"The tDCS active stimulations will be directed to PFC regions for six weeks delivered for three times a week.
~tDCS will be delivered by a battery driven, constant current stimulator through a pair of saline-soaked sponge electrodes kept firm by elastic bands.
~For the OW/OB with diagnosis of BE, or food craving, the anode will be placed on the right PFC, F4 position according to the 10-20 international EEG system for electrode placement, while the cathode will be placed on the left PFC, F3 position according to the 10-20 international EEG system for electrode placement.
~Stimulation intensity will be set at 1 milliampere (mA), the duration of stimulation will be 20 min."
16070064|NCT02382497|Device|BED Sham tDCS|The same electrode placement will be used as in the stimulation conditions (right anodal/left cathodal), but the current will be applied for 30 s and will be ramped down without the participants awareness, and will be held three times a week for six weeks.
16070065|NCT02382484|Device|A dual chamber pacing system (BackBeat Medical)|For each patient, one pacing electrode was placed in the right atrium and the second electrode was placed in the right ventricle. With a dual chamber pacing system (BackBeat Medical) it was possible to pace the heart with a wide variety of pacing settings.
16070066|NCT02382471|Dietary Supplement|Omega-3|4 cap 1 g Omega-3 per day for 2 months
16070067|NCT02382471|Dietary Supplement|Placebo|4 cap 1 g Placebo(paraffin) per day for 2 months
16070068|NCT02382458|Behavioral|Newsletters on cancer prevention and control|E-mailed or mailed newsletters that provide information on how to prevent cancer
16070069|NCT02382458|Behavioral|Behavioral program to reduce inflammation|Group classes which will provide participants with information on achieving a healthy diet, increase physical activity, and manage stress
16070070|NCT02382445|Device|Anesthesia depth monitor|
16070071|NCT02382445|Device|Sham control|Standard care as usual. Bis m Standard care as usual. Bispectral index monitor is not visible for anesthesia provider.
16070072|NCT02382445|Drug|propofol and sevoflurane|
16070073|NCT02382432|Drug|Pethidine 0.4mg/kg|2ml intravenous bolus slowly injected in 2minutes.
16070074|NCT02382432|Drug|Dexmedetomidine|2ml intravenous bolus slowly injected in 2minutes
16070075|NCT02382419|Drug|carrageenan-containing gel|Applied vaginally
16070076|NCT02382419|Other|Placebo|Applied vaginally
16070077|NCT02382419|Other|Laboratory Biomarker Analysis|Correlative studies
16070078|NCT02382419|Other|Questionnaire Administration|Ancillary studies
16070079|NCT02382406|Drug|Carboplatin|Carboplatin AUC 6 IV, D1 for 4 cycles (cycle = 21 days)
16070080|NCT02382406|Drug|Nab-paclitaxel|Nab-paclitaxel 100 mg/m2 IV, D1, D8, D15 for 4 cycles (cycle = 21 days)
16070081|NCT02382406|Drug|MK-3475 (Phase I)|"MK-3475 2 mg/kg IV, D1 for 4 cycles (Cohort 1) or 3 cycles (Cohort 2) (cycle = 21 days)
~Maintenance MK-3475 2 mg/kg IV continues every 21 days after Cycle 4 for up to 2 years."
16070082|NCT02382406|Drug|MK-3475 (Phase II)|"MK-3475 200 mg IV Day 1 of each cycle (cycle = 21 days)
~Maintenance MK-3475 2 mg/kg IV continues every 21 days after Cycle 4 for up to 2 years."
16070083|NCT02382393|Other|Brain Performance Test (BPT, Lumos Labs, Inc)|A brief, repeatable, online battery of cognitive assessments used to measure functioning in five cognitive domains across time.
16070084|NCT02382393|Other|Computerized Assessment|a validated, computerized cognitive assessment tool
16070085|NCT02382380|Drug|Gadoterate|Patients who choose to receive Gadoterate will receive an MRI exam with standard pre-contrast and Gadoterate-enhanced acquisitions (0.2 mL/kg). The MRI protocol utilized in the study will be comprised of the standard Body protocols (routine abdomen, liver-pancreas, renal, prostate, angiography) as well as the standard Neurologic exam protocols (routine brain, orbital, brainstem, neck, angiography).
16070086|NCT02382380|Other|No Gadoterate|Patients who choose not to receive Gadoterate will receive an MRI exam with no Gadolinium contrast. The MRI protocol utilized in the study will be comprised of the standard Body protocols (routine abdomen, liver-pancreas, renal, prostate, angiography) as well as the standard Neurologic exam protocols (routine brain, orbital, brainstem, neck, angiography).
16070087|NCT02382367|Other|Blood sampling|Blood tests (Alpha-1 antitrypsin protein measurement, elastase-inhibitory capacity of plasma measurement, phenotypic and genotypic studies)
16070088|NCT02382354|Drug|remifentanil|The predetermined effect-site concentration of remifentanil was started using modified Dixon's up-and-down method
16070089|NCT02382354|Device|i-gel|I-gel insertion was inserted 5 min after anesthesia induction
16070090|NCT02382354|Device|laryngeal mask airway|laryngeal mask airway insertion was inserted 5 min after anesthesia induction
16070091|NCT02382354|Drug|propofol|Anesthesia was induced with propofol target-controlled infusion at the effect-site concentration of 5 μg/ml
16070092|NCT02382341|Device|BIOSURE™ HEALICOIL™ PK Interference Screw|Subjects will receive the appropriate sized BIOSURE™ HEALICOIL™ PK Interference Screw
16070093|NCT02382328|Drug|alpha lipoic acid|comparison of 600mg/24h oral, alpha lipoid acid, 28 days before and 120 days after surgery (carpal tunnel release) versus placebo in carpal tunnel syndrome patients.
16070094|NCT02382328|Drug|Placebo|Placebo oral pills, 28 days before and 120 days after surgery (carpal tunnel release) versus placebo in carpal tunnel syndrome patients.
16070095|NCT02382315|Behavioral|Fear of Cancer Recurrence Intervention|A 6-week individual therapy intervention to address fear of cancer recurrence in male and female cancer survivors. Patients will learn tools and techniques to help manage their fears, and learn to tolerate the uncertainty associated with the possibility of their cancer recurring.
16070096|NCT02382302|Device|Telemedicine system|The data such as photographs can be collected simply using built-in cameras installed in smart-phones that used the standard touch-screen user interface (UI) and camera installed in the iPhone3GS and iPhone4 using iOS 3.0 and iOS 5.0, respectively. Subjects were instructed to transmit the photographs of the wounds then investigator performed the photography in such a manner that the size of pressure ulcer should be automatically measured based on a 1 cm x 1 cm-sized indicator on the screen.
16070097|NCT02382289|Procedure|radiofrequency ablation for sacroiliac joint arthropathy|comparing bipolar RF at 6 points with monopolar RF at 3 and 6 points for the treatment of SI arthropathy
16070098|NCT02382276|Drug|Nalmefene hydrochloride|
16070099|NCT02382263|Drug|Nab-paclitaxel 150 mg/m2 + Gemcitabine 1000 weeks 1,3/4|Nab-paclitaxel 150 mg/m2 + Gemcitabine 1000 days 1 & 15 in a 28 days cycle
16070100|NCT02382263|Drug|Nab-paclitaxel 100 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4|Nab-paclitaxel 100 mg/m2 + Gemcitabine 1000 days 1,8 & 15 in a 28 days cycle
16070101|NCT02382263|Drug|Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,3/4|Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 days 1 & 15 in a 28 days cycle
16070102|NCT02382263|Drug|Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 weeks 1,2,3/4|Nab-paclitaxel 125 mg/m2 + Gemcitabine 1000 days 1,8 & 15 in a 28 days cycle
16070103|NCT02382250|Behavioral|Survey|Survey will be given to all participants
16070104|NCT02382237|Device|PET/TDM|Evaluation of nutrition absorption by TEP/TDM
16070105|NCT02382224|Behavioral|Worry Exposure for GAD|WE is an optimized protocol that incorporates elements of CBT, without the addition of other miscellaneous methods of treatment. A therapist manual will be used and followed at all times to ensure standardized delivery of the program. Interventions that uniquely focus on addressing GAD symptoms will include confronting physical or imagined stimuli through in vivo exposure and WE respectively. Avoidance behaviors will be monitored and reduced systematically, an outcomes will be assessed at baseline, during the 12-week intervention, and at 6-month follow-up.
16070106|NCT02382224|Behavioral|12-week Waitlist|Those who are randomized to the waitlist condition will wait for 12 weeks before beginning the worry exposure.
16070107|NCT02382198|Drug|Glycopyrrolate|Drug to reduce drooling in patients with Parkinson's Decease.
16070108|NCT02382198|Drug|Placebo|
16070109|NCT02382185|Other|Fluid optimisation|The intervention will consist of optimising stroke volume with 250ml of Hartmanns solution
16070110|NCT02382185|Drug|Optimisation of blood pressure|Phenylephrine infusion will be used to target a mean arterial blood pressure to within 30% of baseline (preoperative) value
16070201|NCT02381496|Drug|ACT-453859 800 mg|Capsule
16070111|NCT02382185|Device|Application of clearsight monitor|The clear sight monitor will be applied to measure stroke volume.
16070112|NCT02382172|Behavioral|Social Cognition and Interaction Training for Autism (SCIT-A)|The group therapy program is aimed at improving social cognitions and skills of individuals who find social situations difficult, stressful and/or uncomfortable and with a desire to enhance skills required for social interactions.
16070113|NCT02382172|Other|Treatment as Usual (TAU)|Participants in the treatment as usual (TAU) group will continue to receive other interventions (e.g., individual therapy, job skills coaching) during the Social Skills Clinic. No participants in either group will participate in other group-based interventions concurrently with their participation in this study.
16070114|NCT02382146|Drug|dexamethasone ondansetron|dexamethasone 8 mg intravenous ondansetron 4 mg intravenous dimenhydrinate 1mg/kg intravenous
16070115|NCT02382146|Drug|Dexamethasone dimenhidrinate|dexamethasone 8 mg intravenous dimenhydrinate 1mg/kg intravenous
16070116|NCT02382133|Device|Nasal alar oxygen sensor|Application of a nasal alar oxygen sensor
16070117|NCT02382107|Other|Observational|TB suspects, who present themselves to the pulmonary ambulance at the Marius Nasta Instiute
16070118|NCT02382094|Drug|Bicalutamide|
16070119|NCT02382081|Procedure|Patient-initiated shared care|
16070120|NCT02382068|Drug|Dexamethasone|Given via intratympanic injection
16070121|NCT02382068|Other|Placebo|Given via intratympanic injection
16070122|NCT02382068|Drug|Cisplatin|"Standard of care treatment with the following treatment course criteria:
~Dose: > 50 mg/m2
~Frequency: q3 -q4 weeks
~Cycles: 7 maximum"
16070123|NCT02382055|Behavioral|REACH|REACH is a 12-session intervention, delivered 2-3 times per week for 45 minutes. The treatment focuses on identifying and changing behaviors and routines that have become entrenched and help perpetuate the illness.
16070124|NCT02382055|Behavioral|Supportive Psychotherapy|The Supportive Psychotherapy is based on the Specialist Supportive Care (McIntosh et al, 2005), and modified for the current research procedures. Supportive Psychotherapy is a 12-session intervention, delivered 2-3 times per week as 45 minute sessions, focusing on symptoms of anorexia nervosa during the transition to the inpatient unit.
16070125|NCT02382055|Behavioral|Inpatient Behavioral Treatment|Inpatient treatment at the NYSPI is a behaviorally-based treatment program for anorexia nervosa. This is a non-research, clinical intervention for individuals with anorexia nervosa.
16070126|NCT02382042|Behavioral|Intensive Referral Intervention|
16070127|NCT02382029|Drug|Clonazepam|Active medical treatment for burning mouth syndrome
16070128|NCT02382029|Other|acupuncture|Traditional chinese acupuncture
16070129|NCT02382016|Drug|Macitentan|Macitentan film-coated tablet 10 mg once daily.
16070130|NCT02382016|Other|Placebo|Matching placebo tablet once daily.
16070131|NCT02382003|Behavioral|Positive Cognitive Bias Modification - Interpretation|Training involves presenting participants with brief scenarios that introduce an ambiguous potential threat. Critically, the ambiguity regarding how the situation is resolved remains until the last word of the scenario, which is presented as a word fragment that the participant must solve, which will then assign a benign (rather than threatening) meaning to the scenario.
16070132|NCT02382003|Behavioral|50/50 Cognitive Bias Modification - Interpretation|This condition follows the same design and content as the Positive Training conditions, except the word fragments differ; rather than consistently resolving the scenario in a positive direction, half of the scenarios will end with a negative (anxiety-congruent) word fragment, and half will end with a positive word fragment.
16070133|NCT02382003|Behavioral|Anxious Imagery Prime|We will test whether priming anxious concerns and feared negative outcomes on the web via the addition of a guided anxious imagery prime at the start of each session will enhance effects.
16070134|NCT02382003|Behavioral|Neutral Imagery Prime|At the start of each session, participants will complete a neutral control imagery exercise where they do a guided imagery exercise imagining upcoming mundane tasks, like brushing one's teeth.
16070135|NCT02381990|Procedure|FUSE IMAGE MRI GUIDED PROSTATE CRYOTHERAPY|"Biopsy proven Prostate Cancer is delimited and defined by MP-MRI. The MRI study is fused with transrectal ultrasound in realtime. The cryogenic cryoprobes/devices are employed to freeze and all circuled or noted cancer lesions. Two freeze 8 min/ thaw 10 min clycles are performed. Thermocouples are used to monitor treatment areas and safety margins"
16070136|NCT02381977|Other|No intervention|
16070137|NCT02381964|Dietary Supplement|Supradyn® (1RDA+CoQ10)|
16070138|NCT02381964|Dietary Supplement|Supradyn® (3RDA)|
16070139|NCT02381964|Dietary Supplement|Placebo|
16070140|NCT02381951|Device|spinal cord stimulation (St Jude Medical)|implantation of a spinal cord neurostimulation system : St Jude Medical Octrode 3183 (R) peridural lead connected to a St Jude Medical EonC (R) primary cell IPG
16070141|NCT02381938|Behavioral|Healthy Lifestyles|6-month intervention to increase physical activity and improve other health related behaviors
16070142|NCT02381938|Other|Healthy Finances|6-month intervention to educate and improve financial health
16070143|NCT02381912|Other|EORTC QLQ-C30 and EORTC BLS-24 questionnaire|Questionnaires answered at baseline and 4 months follow up.
16070144|NCT02381899|Drug|Bendamustine and Rituximab|Patients receive bendamustine and rituximab. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
16070145|NCT02381886|Drug|IDH305|
16070146|NCT02381860|Other|Placebo|One bolus of less than 5% fruit cordial mixed with water, maltodextrin and whey protein isolate to match for carbohydrate and calorie content of the juice.
16070147|NCT02381860|Dietary Supplement|60mL tart Montmorency cherry juice|One bolus of 60mL of tart Montmorency concentrate mixed with 100mL of water.
16070148|NCT02381847|Procedure|intraperitoneal chemoperfusion|HIPEC with cisplatin at the time of D2 radical surgery
16070149|NCT02381834|Procedure|Bladder stimulation technique|
16070202|NCT02381496|Other|Placebo|Matching ACT-453859 placebo capsule
16070203|NCT02381496|Drug|Setipiprant 500 mg|Capsule
16070204|NCT02381496|Drug|Setipiprant 1000 mg|Capsule
16070205|NCT02381483|Other|Cold exposure|
16070206|NCT02381470|Drug|Faropenem|Faropenem 600mg
16070207|NCT02381470|Drug|Amoxicillin/clavulanic acid|Amoxicillin 500mg/ clavulanic acid 125mg
16070208|NCT02381470|Drug|Cefadroxil|Cefadroxil 1g
16070209|NCT02381470|Drug|Rifampicin|Rifampicin 10mg/kg
16070150|NCT02381821|Other|3 D ultrasound and Doppler examination|Endometrial thickness was measured in the longitudinal plane at the widest anteroposterior diameter with a trans-vaginal 2D ultrasound, and then 3D mode was then activated with power Doppler setting for this study standardized using a frequency at 4-9 MHZ pulse repetition frequency at 0.5KHz gain at-3.0 and wall motion filter at 1. The sub-endometrial region was considered to be within 3 mm of the originally defined myometrial-endometrial contour. The endometrial volume (EV) and 3D power Doppler indices below the endometrium were measured using the automated VOCAL™ for the 3D power Doppler histogram analysis
16070151|NCT02381821|Drug|GnRH agonist|All women received daily subcutaneous 0.1 mg triptorelin injection started from day 21) of the cycle preceding stimulation. Downregulation of the pituitary gonadotropins was confirmed after 12 days , gonadotropin (Gn) induction was started using Human menopausal gonadotropins for ovarian stimulation. The starting dose was 225 to 300 IU . Ultrasound Folliculometry was done every other day . When two or more follicles reached a minimum mean diameter of 18 mm, triggering of ovulation trigger was done using Human chorionic gonadotropin (hCG) 10,000 IU and ovum pick up was scheduled 36 hours later
16070152|NCT02381795|Drug|Nasal Carbon Dioxide|
16070153|NCT02381769|Dietary Supplement|Soybean based lipid emulsion|
16070154|NCT02381756|Device|Ultrasound|Cardiac echocardiography to determin the left ventricular ejection fraction by the biplane modified Simpson rule and by the calculation of the Strain Longitudinal Global by 2-D speckle tracking strain echocardiography
16070155|NCT02381743|Behavioral|Group 2 intervention daily SMS bullet point|Group 2 subjects receive a daily SMS bullet point, summarizing a key clinical point pertinent to the CBPA's daily work.
16070156|NCT02381743|Behavioral|Group 3 intervention daily SMS bullet point|Group 3 subjects receive a c phrased as a multiple choice question. The content mirrors that of group 2, but is presented as a question to render it interactive
16070157|NCT02381730|Drug|Intravitreal aflibercept|Patient receive one intravitreal injection of 2mg aflibercept (as currently recommended in the treatment of AMD)
16070158|NCT02381717|Other|ultra-sound guide|Patients randomized to this arm will have the femoral nerve block with the guidance of a bedside ultrasound
16070159|NCT02381717|Drug|bupivacaine|
16070160|NCT02381717|Drug|morphine|
16070161|NCT02381691|Other|maternal breast milk odor|
16070162|NCT02381691|Other|no odor|
16070163|NCT02381678|Device|Perimount 2900/6900 Heart Valve|This is a retrospective study which ask the subjects implanted with Perimount Heart Valve during 2001 to 2007 back hospital for follow up visit.
16070164|NCT02381665|Device|Flexstim IF|Patient enrolled will receive a device for effective interferential current stimulation
16070165|NCT02381665|Device|Flexstim IF faked|Patient enrolled will receive a sham device.
16070166|NCT02381652|Combination Product|Cingal|Injection into the knee
16070167|NCT02381652|Combination Product|Cingal|Injection into the knee
16070168|NCT02381652|Combination Product|Cingal|Injection into the knee
16070169|NCT02381639|Behavioral|One interview of 90 minutes with a part of cognitive assessment and a part of self-assessment|The content of the assessment will be the same for all subjects and will consist of a part of cognitive assessment (National Reading Test, Rey Osterreich Complex Figure, Hayling Sentence Completion Task, verbal memory, digit sequencing, token motor task, verbal fluencies, symbol coding, tower of London) and self-assessment (Mini International Neuropsychiatric Interview, Beck Depression Inventory, State Trait Anxiety Inventory, Wender Utah Rating Scale, Adult Self-Report Scale Symptom Checklist, UPPS Impulsive Behavior Scale)
16070170|NCT02381626|Device|HEPA air purifier|air purifiers to remove PM and volatile organic compounds will be placed in drivers cars
16070171|NCT02381626|Behavioral|questionnaires|
16070172|NCT02381626|Other|Log-book|PM and biological measurements
16070173|NCT02381626|Other|Urine sample|PAH (Polycyclic Aromatic Hydrocarbon) will be assessed via urine sample collection of Urinary 1 hydroxy pyrene and particulate matter collected via Polyurethane Foam Filter (PUF) sampler
16070174|NCT02381613|Other|Baked beef|A meal based on baked beef
16070175|NCT02381613|Other|Baked herring|A meal based on baked herring
16070176|NCT02381613|Other|Pickled herring|A meal based on pickled herring
16070177|NCT02381600|Drug|Vitamin D|"Experimental :
~Patients will undergo clinical and functional assessment as well as evaluation using the Montreal Cognitive Assessment (MoCA) screening test, the modified 15-item Geriatric Depression Scale, and the Neurotrax (®Mindstreams) computerised cognitive assessment battery.
~Patients will receive a supplemental monthly oral dose of 60000 units Vitamin D administered by a nurse for a period of 3 months Patients will undergo a repeat blood test to examine the level of vitamin D at the end of 3 months of follow-up.
~At 3-month follow-up atients will be asked to complete the 15-item GDS and the Neurotrax (®Mindstreams) computerised cognitive assessment battery."
16070178|NCT02381587|Other|Retrospective study|no interventional study - Retrospective study that valuate The effect of HCQ treatment in cardiovascular AVENTS IN patients with primary sjogren syndrome
16070179|NCT02381561|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16070180|NCT02381561|Other|Laboratory Biomarker Analysis|Correlative studies
16070181|NCT02381561|Other|Pharmacological Study|Correlative studies
16070182|NCT02381561|Drug|Ropidoxuridine|Given PO
16070183|NCT02381548|Drug|Adavosertib|Given PO
16070184|NCT02381548|Drug|Belinostat|Given IV
16070185|NCT02381548|Other|Laboratory Biomarker Analysis|Correlative studies
16070186|NCT02381548|Other|Pharmacological Study|Correlative studies
16070194|NCT02381509|Device|IVC Filter|
16070195|NCT02381496|Drug|ACT-453859 1 mg|Capsule
16070196|NCT02381496|Drug|ACT-453859 3 mg|Capsule
16070197|NCT02381496|Drug|ACT-453859 10 mg|Capsule
16070198|NCT02381496|Drug|ACT-453859 30mg|Capsule
16070199|NCT02381496|Drug|ACT-453859 100 mg|Capsule
16070200|NCT02381496|Drug|ACT-453859 300 mg|Capsule
16070211|NCT02381418|Biological|Trivalent influenza subunit vaccine Influvac|"3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1 "
16070212|NCT02381405|Dietary Supplement|Enterade beverage|
16070213|NCT02381392|Device|Accuvein AV400|This device is FDA approved for assistance with intravenous access. It has been shown to cause no harm to patients. The device utilizes infrared technology to provide a visible map of the subject's blood vessels where the light is shone.
16070214|NCT02381379|Drug|Peginterferon-α-2a|Subcutaneous peginterferon-α-2a (PEGASYS®) starting at 180µg weekly for one year.
16070215|NCT02381366|Biological|Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells|"Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells:
~Dose A: 10 million cells per kg / Dose B: 20 million cells per kg"
16070216|NCT02381353|Drug|Bupivacaine|Intraoperative orbital injection of local pain medication
16070217|NCT02381340|Device|ACE stapling procedure|Endoscopic trans-oral gastroplication
16070218|NCT02381327|Device|Mandometer|Mandometer is an eating disorder conditioning tool, class 2 device cleared by the FDA for the treatment of eating disorders. Mandometer offers on-line, real-time feedback on how much food to eat and how quickly to eat during a meal.
16070219|NCT02381314|Biological|enoblituzumab plus ipilimumab|enoblituzumab is administered by IV infusion once per week. Ipilimumab is administered by IV infusion every 3 weeks for up to 4 doses.
16070220|NCT02381301|Biological|Venous blood sampling prior to CCTA.|
16070221|NCT02381288|Drug|TAK-448|TAK-448 solution for subcutaneous injection
16070222|NCT02381288|Drug|TAK-448 Placebo|TAK-448 placebo-matching solution for subcutaneous injection
16070223|NCT02381275|Drug|Tenofovir Disoproxil Fumarate|Observe long-term outcomes of patients using Tenofovir based antiretroviral therapy at the Lighthouse Clinics
16070224|NCT02381262|Behavioral|Fitbit|The Fitbit is a wrist based wearable technology device designed to monitor physical activity by tracking steps, distance and calories burned as well as sleep patterns and heart rate. It has wireless capabilities to sync with smart devices and summarize data for the user or export for synchronize with electronic health records.
16070225|NCT02381249|Drug|Octreotide|Single dose 100mcg octreotide acetate (1mL), subcutaneously to the lower abdomen
16070226|NCT02381249|Drug|Placebo|Single dose 0.9% saline (1mL), subcutaneously to the lower abdomen
16070227|NCT02381236|Drug|G-202|G-202 administered by intravenous infusion on Days 1, 2 and 3 of each 28-day cycle for up to 3 cycles
16070228|NCT02381210|Device|Congo Red Dot Test|The Congo Red Dot test is a simple test has been developed to detect unfolded or misfolded proteins in urine.
16070229|NCT02381197|Device|Congo Red Dot test|The Congo Red Dot test is a simple dye test that detects unfolded or misfolded proteins
16070230|NCT02381184|Drug|clomiphene citrate|receive100 mg of clomiphene citrate (Clomid®; Hoechst Marion Russel, Cairo, Egypt) daily starting on day 3 of spontaneous or progestin induced cycle for 10 days.
16070231|NCT02381184|Procedure|laparoscopic ovarian drilling (LOD)|Laparoscopy was performed under general anesthesia, using three-puncture technique
16070232|NCT02381171|Device|Active rTMS|Repetitive Transcranial Magnetic Stimulation (rTMS) 10Hz (1600 pulses)
16070233|NCT02381171|Device|Sham rTMS|Repetitive Transcranial Magnetic Stimulation (rTMS) with Placebo coil
16070234|NCT02381171|Device|Active Neuroacupuncture|Neurofunctional electrical acupuncture 1Hz, continuous, 10mA current for 20 minutes.
16070235|NCT02381171|Device|Sham Neuroacupuncture|Neurofunctional electrical acupuncture without needles
16070236|NCT02381158|Drug|Nebulized beclomethasone dipropionate|Nebulized beclomethasone dipropionate applied for 12 weeks with a dose of 400 µg twice a day (total dose 800 µg)
16070237|NCT02381145|Dietary Supplement|EGCG+RSV-supplementation|Teavigo (~300mg/d) Resveratrol (~80mg/d)
16070238|NCT02381145|Dietary Supplement|Placebo|
16070239|NCT02381132|Drug|Norco 7.5mg/325|
16070240|NCT02381132|Drug|MNK155|
16070241|NCT02381119|Behavioral|Personalized Dietary Advice Services|"This Personalized Dietary Advice is based on markers for nutrition status and SNPs (single nucleotide polymorphisms).
~This advice is given via Personalized Dietary Advice Services, in which health data of the client can be entered and will be translated into advice on intake of specific nutrients or food categories."
16070242|NCT02381119|Behavioral|Regular care|The control group will receive usual advice for diabetes type 2 from the dietician. However, after the end of the study participants in the control group will be offered the opportunity to receive the Personalized Dietary Advice from their dietician, as based on the parameters measured during the study.
16070243|NCT02381093|Other|Modified BLS course|BLS using CI
16070244|NCT02381093|Other|Standard BLS Course|Usual BLS teaching
16070245|NCT02381080|Drug|Ibrutinib|Ibrutinib capsule (at dose level of 140 or 420 or 560 mg) will be taken orally QD up to six, 28-days cycles.
16070246|NCT02381080|Drug|Erythromycin|Erythromycin 500 mg tablet will be taken orally TID (Part1 Cycle 1: on Days 5-10 and morning dose on Day 11; Part2 Cycle 1: on Days 5-17 and morning dose on Day 18).
16070247|NCT02381080|Drug|Voriconazole|Voriconazole 200 mg tablet will be taken orally BD (Part1 Cycle 1: on Days 19-25; Part2 Cycle 1: on Days 5-17).
16070248|NCT02381067|Other|NuCel with Allograft Bone|NuCel is a minimally manipulated allograft product derived from amniotic membrane along with cells from amniotic fluid. Allograft bone is bone that comes another patient. NuCel and Allograft bone will be combined for this treatment.
16070249|NCT02381028|Other|Human milk and emollient: Apobase creme® (Actavis Norway AS)|Topical application of human milk followed by emollient
16070250|NCT02381028|Other|Emollient: Apobase creme® (Actavis Norway AS)|Topical application of emollient
16070251|NCT02381015|Genetic|Genetic Risk Score: Number Format|Genetic Risk Score: Number + Pictograph Genetic risk score based on validated panel of 46 single nucleotide polymorphisms previously identified to be associated with Prostate Cancer risk by Genome Wide Association Studies, presented to subjects as a number.
16070252|NCT02381015|Genetic|Genetic Risk Score: Number + Pictograph|Genetic Risk Score: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
16070253|NCT02381015|Behavioral|Family History: Number Format|Family History: Number Format Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
16070321|NCT02380547|Other|Sonographic diaphragmatic measurements|
16071147|NCT02374567|Drug|Amitriptyline oxide|
16070254|NCT02381015|Behavioral|Family History: Number + Pictograph|Family History: Number + Pictograph Risk information conveyed as either a number or a number + pictograph, depending on randomization group.
16070255|NCT02381002|Other|Weight reduction program|Overweight and obese children (6-12 years old) from patient group accepting enrollment were assigned to weight reduction program for 6 months with monthly follow up. The program comprise: 1) Diet regimen: Healthy balanced diet was prescribed. The amount of calories was determined according to 24-hour recall then 250-500 calories were subtracted from total intake which decrease weight by 0.25-0.5 kg/week. 2) Exercise:were instructed to practice walking for at least 30 minutes 3-4 times per week.
16070256|NCT02380989|Device|Ayurveda|Ayurveda combinations in the form of gel and patches were applied on acute pain site.
16070257|NCT02380989|Device|Placebo|
16070258|NCT02380976|Drug|combination drug: DW330SR, DW1030|
16070259|NCT02380976|Drug|DW340|
16070260|NCT02380963|Dietary Supplement|Colorado Diet with soy protein foods.|"Phase 1 (week 1-2): Participants will be given soy protein powder and asked to consume 3 protein shakes per day.
~Phase 2 (week 3-8): Participants will be given both protein powder and soy patties designed to be similar to other phase 2 acceptable foods and will be asked to consume 2 soy protein shakes and 1 soy patty per day.
~Phase 3 (week 9-16): Participants will be given protein powder, soy patties, and protein bars designed to be similar to other phase 3 acceptable foods and will be asked to consume 1 soy protein shake, 1 soy patty and 1 soy protein bar per day.
~Maintenance Phase (month 5-12): Participants will continue to receive study food products (protein powder, patties and protein bars)"
16070261|NCT02380963|Behavioral|Colorado Diet with monetary payments|"Phase 1 (week 1-2): Participants will be given monetary stipend and asked to consume 3 non-soy protein shakes per day.
~Phase 2 (week 3-8): Participants will be given monetary stipends and asked to consume 2 non-soy protein shakes per day.
~Phase 3 (week 9-16): Participants will be given monetary stipend and asked to consume 1 non-soy protein shake and 1 non-soy protein bar per day.
~Maintenance Phase (month 5-12): Participants will continue to receive monetary stipend."
16070262|NCT02380950|Behavioral|250 ml alcohol consumption|"Each participant had to drink 250 ml white wine. Directly before, 10-30 min after and 45-65 min after wine consumption cognitive functions were tested by test battery for attentional performance (TAP) from Zimmermann and Fimm. During the whole examination breath-alcohol-contents (BACs) were measured every 5 minutes with breathalyser Dräger Alcotest 7510."
16070263|NCT02380937|Procedure|ablation for typical atrial flutter|ablation for typical atrial flutter
16070264|NCT02380937|Device|Vision Ablation Catheter|
16070265|NCT02380924|Drug|DSP loaded RBC using EryDex System|Intravenous infusion of 10 mg DSP encapsulated in autologous erythrocytes. Peripheral blood samples are taken over 49 days to determine the 24-hour recovery and survival (T50) of the infused RBC.
16070266|NCT02380924|Drug|Sham treated RBC using the EryDex System|Intravenous infusion of sham treated autologous erythrocytes. Peripheral blood samples are taken over 49 days to determine the 24-hour recovery and survival (T50) of the infused RBC.
16070267|NCT02380911|Other|Educational Intervention|"Physicians belonging to the PCC randomized to the intervention group receive a 3-component intervention: education workshop, Educational Outreach Visits and a mHealth application uploaded to their smartphones.
~In addition, 2 intervention support tools are used at the intervention clinics:
~A web-based platform that is tailored to send SMS messages for lifestyle modification, and prompts and reminders for clinic appointments are used to improve medication adherence for patients.
~On-site training to pharmacist assistants at the first EOV is given by physician trainers focused on counseling to improve medication adherence among patients initiating statin therapy and at each patient visit to the clinic to refill drug prescriptions."
16070268|NCT02380898|Drug|Ketorolac|30 mg ketorolac immediately before induction of anesthesia
16070269|NCT02380898|Drug|Normal saline|4 mL normal saline 0.9% immediately before induction of anesthesia
16070270|NCT02380885|Behavioral|SCIT|psychosocial group intervention
16070271|NCT02380885|Behavioral|TAFT|psychosocial group intervention
16070272|NCT02380872|Procedure|Connective tissue graft|gingival recession treated with connective tissue graft
16070273|NCT02380872|Procedure|Platelet Rich Fibrin|gingival recession treated with platelet rich fibrin
16070274|NCT02380859|Behavioral|Prism adaptation|Prism adaptation is one type of sensorimotor adaptation. Prism adaptation described any adaptation to a prismatic shift in vision (i.e. any magnitude or direction of shift). In this study we are using adaptation to upward-shifting prisms, which induces a downward sensorimotor after-effect.
16070275|NCT02380846|Other|White rice|Control - white rice
16070276|NCT02380846|Other|Rice with chicken breast|Treatment 1 - steamed white rice with steamed chicken breast
16070277|NCT02380846|Other|Rice with fish|Treatment 2 - steamed white rice with steamed fish
16070278|NCT02380846|Other|Rice with egg white|Treatment 3 - steamed white rice with egg white
16070279|NCT02380846|Other|Rice with beancurd|Treatment 4 - steamed white rice with steamed beancurd
16070280|NCT02380833|Behavioral|MyPlate|To consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations for eight weeks.
16070281|NCT02380833|Behavioral|MyPlate + Exercise|To consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations and aerobic and resistance training four days per week for eight weeks.
16070282|NCT02380833|Behavioral|Paleolithic|To consume a weight maintenance diet based on alternative (Paleolithic based) nutrition recommendations for eight weeks.
16070283|NCT02380833|Behavioral|Paleolithic + Exercise|To consume a weight maintenance diet based on alternative (Paleolithic based) nutrition recommendations and aerobic and resistance training four days per week for eight weeks.
16070284|NCT02380820|Device|Airsoft Duo mattress|A multi-layer mattress for pressure sore prevention. Made by NAUER FOAMPARTNER AG et OBA AG (Germany).
16070285|NCT02380820|Device|Softform Premier mattress (in static mode)|A multi-layer mattress for pressure sore prevention. Made by INVACARE MSS (United Kingdom).
16070286|NCT02380807|Device|Dry Needling|"Dry needling is the use of either solid filiform needles or hollow-core hypodermic needles for therapy of muscle pain, sometimes also known as intramuscular stimulation (IMS). Although dry needling originally utilized only hypodermic needles due to the concern that solid filiform needles had neither the strength or tactile feedback that hypodermic needles provided and that the solid filiform needle could be deflected by dense contraction knots."
16070287|NCT02380807|Other|Cross Tape Therapy|The tape consists of cross bands or strips mesh cross, nonelastic and without any medication, forming a grid-shaped patch. The cross tape will be applied on trigger points.
16070288|NCT02380794|Drug|Danshen Gegen Capsule|"Danshen can dilate blood vessels, reduce the number of angina attacks and significantly improve endothelial function in patients with Coronary Angina Pectoris.
~Gegen is also effective in dilating cardiovascular and cerebrovascular of the brain, and improving blood circulation. The main active ingredient of Gegen isoflavones is effective in dilating the coronary arteries, improving metabolism in normal and ischemic myocardium and reducing blood pressure, heart rate and myocardial oxygen consumption."
16070289|NCT02380794|Drug|Placebo|
16070290|NCT02380781|Behavioral|Information in the form of a video|see intervention description
16070291|NCT02380768|Device|Ambu AuraGain (size 1.5 or size 2.0)|The device will be inserted and timed. A leak pressure test will be performed after successful insertion and after 10 minutes. The larynx will be visualized by placing a fiberoptic bronchoscope through the device. A gastric tube will be inserted through the device and timed.
16070292|NCT02380768|Device|LMA Supreme (size 1.5 or size 2.0)|The device will be inserted and timed. A leak pressure test will be performed after successful insertion and after 10 minutes. The larynx will be visualized by placing a fiberoptic bronchoscope through the device. A gastric tube will be inserted through the device and timed.
16070293|NCT02380755|Drug|Clomiphene Citrate|50 mg orally daily during 12 weeks
16070294|NCT02380755|Drug|Placebo|1 pill orally daily during 12 weeks
16070295|NCT02380742|Drug|lidocaine-prilocaine cream|The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of EMLA cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
16070296|NCT02380742|Drug|Placebo cream|The patient will then be positioned in dorsal lithotomy position with the use of stirrups. Two mL of placebo cream will be placed into the vagina and 2 mL will be spread on the perineum. The cream placed into the vagina will be introduced to the level of the pessary with the practitioners' finger. Once application is completed, a timer will be set for five minutes. After five minutes, the patient will again be placed into dorsal lithotomy position with the use of stirrups. The pessary will be removed per practitioners' usual practice. The patient will be asked to mark her pain score for at this point
16070297|NCT02380729|Genetic|Gene Panel Sequencing|Enrichment for and panel sequencing of 2942 disease genes listed in the Online Mendelian Inheritance of Man (OMIM) database.
16070298|NCT02380729|Genetic|Whole Genome Sequencing (WGS)|Whole Genome Sequencing of the index case and of both parents in the event that Gene Panel Sequencing did not identify a disease-causing mutation.
16070299|NCT02380703|Behavioral|Aggression Prevention Training (APT)|
16070300|NCT02380703|Other|Enhanced Usual Primary Care (EU-PC)|
16070301|NCT02380690|Behavioral|Peer Coach Assignment|Veterans will be assigned a peer coach to meet with for 6 months to discuss pain self-management.
16070302|NCT02380677|Drug|CRLX301|
16070303|NCT02380664|Device|Whole-body vibration (Powerplate®)|Swimmers will perform a 15 minute whole-body vibration training 3 times per week. This intervention will be performed with a Powerplate®. The vibration protocol will be progressive starting with 30 Hz and an amplitude op 4 mm reaching at the end of the protocol 38 Hz and 4 mm amplitude.
16070304|NCT02380664|Behavioral|Jumping intervention|Swimmers will perform a jumping intervention, 15 minutes 3 times per week. Jumps will include drop jumps, one leg jumps, squat jumps and countermovement jumps.
16070305|NCT02380651|Procedure|Limb salvage|Local or free flaps
16070306|NCT02380638|Device|Whole-body vibration training (Power Plate®) on bone mass and bone metabolism in adolescents with and without Down syndrome.|
16070307|NCT02380625|Drug|Azithromycin|Adults (>18 yrs): 3 x 500mg tablets daily for 5 days; Children (6 months to <18 yrs): 30mg/kg (oral suspension) daily for 5 days
16070308|NCT02380625|Drug|Sunitinib and Erlotinib|Sunitinib - Adults (>18 yrs): 1 x 50mg tablet daily for 7 days; Children (6 months to <18 yrs): 0.83 mg/kg (oral suspension) daily for 7 days. Erlotinib - Adults (>18 yrs): 1 x 150mg tablet daily for 7 days; Children (8kg to <20kg): 3.5 mg/kg daily for 7 days; Children (>20kg to <30kg): 3.0 mg/kg daily for 7 days; Children (>30kg to < 18 yrs): 25 mg/kg daily for 7 days
16070309|NCT02380625|Drug|Atorvastatin and Irbesartan|Atorvastatin - Adults (>18 yrs): 1 x 40mg tablet daily until discharge; Children (6 years to <18 yrs): 1 x 40mg tablet daily until discharge; Irbesartan - Adults (>18 yrs): 1 x 150mg tablets daily until discharge; Children (6 years to <18 yrs): 1 x 75mg tablet daily until discharge.
16070310|NCT02380625|Other|IV fluids and laboratory testing|All arms will receive aggressive IV fluid rehydration and frequent laboratory tests to assist with medical management as indicated.
16070311|NCT02380612|Device|ReCell Treatment|
16070312|NCT02380612|Procedure|Skin Graft|
16070313|NCT02380599|Other|Spinal Manipulation|Mid-thoracic spinal manipulation to T3-5 region
16070314|NCT02380599|Other|Spinal Mobilization|Mid-thoracic spinal mobilization to T3-5 region
16070315|NCT02380599|Other|Sham Ultrasound|Sham ultrasound to T3-5 region
16070316|NCT02380586|Procedure|Obstetric anesthesia and analgesia|All anesthesia procedures during labor: labor analgesia, anesthesia for Cesarean section, anesthesia for procedures in third stage of labor
16070317|NCT02380573|Drug|Methylene Blue|
16070318|NCT02380573|Drug|FD&C Blue # 2|
16070319|NCT02380573|Drug|Phenazopyridine hydrochloride|
16070320|NCT02380560|Device|Ultrasonographic examination|"An abdominal ultrasound for: Estimation of gestational age, biophysical profile (BPP), Detection of any fetal gross anomalies, Assessment of fetal growth measurement of the Amniotic Fluid Index (AFI), Detection of any abnormal placental insertion and/or uterine structural abnormalities as septate or bicornuate uterus, measuring The myometrial thickness at 4 different sites:
~a) The lower uterine segment (LUS): 2cm above the reflection of the full urinary bladder (b)The anterior wall: 1cm above the maternal umbilicus. (c)Fundus: by placing the scan probe perpendicularly above the uterine fundus so that the entire curvature of the uterus is visualized.
~(d)The posterior wall: through using the maternal abdominal aortic pulsation as an anatomic marker."
16070322|NCT02380534|Procedure|H.E.L.P. apheresis|High cardiovascular risk patients will undergo H.E.L.P. apheresis procedure every 3 weeks for 1 year.
16070323|NCT02380521|Drug|Exenatide once weekly (BYDUREON™)|"Exenatide is considered investigational medicinal product (IMP) and will be prescribed to enrolled patients in accordance with local requirements.
~Exenatide will be available at a fixed dose of 2 mg and supplied as a kit. Exenatide should be injected subcutaneously (SC) in the thigh, upper arm (deltoid region) or abdomen. The injection site does not have to be consistent throughout the study. Injection can be done at any time of the day irrespective of meals. It is recommended that the time of injection is consistent throughout the study. Subjects will be instructed to perform an air shot before the first injection.
~Subjects will follow a fixed dose of 2 mg"
16070324|NCT02380508|Drug|BCG SSI|Intradermal injection
16070325|NCT02380508|Other|No vaccination|
16070326|NCT02380508|Drug|BCG Sii|intradermal injection
16070327|NCT02380495|Other|Data Collection|
16070328|NCT02380482|Other|Transthoracic echocardiography on TBI patients|Two Dimensional and speckle trackingTransthoracic echocardiography on TBI patients within 24 hours of trauma
16070329|NCT02380482|Other|Transthoracic echocardiography on control patients|Two Dimensional and speckle trackingTransthoracic echocardiography on control patients while intubated-ventilated
16070330|NCT02380469|Behavioral|Identification and provision of lacking information|The intervention consists of an interview about the caregiver's responses (baseline measurement) to a list about 'lack of information' within 13 areas. For each area, the patient's nurse will enquire about what information is requested by the caregiver and the patient. Subsequently, the nurse provides the requested information. She may involve the doctor and arrange follow-up visits or phone calls until the need is covered
16070331|NCT02380443|Biological|AlloStim|AlloStim is an activated living CD4+ Th1 memory cell derived from the blood of normal blood donors and intentionally mismatched to the recipient. AlloStim is bioengineered to express high levels of Type 1 inflammatory cytokines (such as interferon-gamma, TNF-alpha, GM-CSF) and immunomodulatory molecules such as CD40L. AlloStim has CD3/CD28-coated microbeads attached to assure activation upon infusion.
16070332|NCT02380443|Procedure|Cryoablation|Percutaneous partial cryoablation of a single metastatic tumor lesion in the liver. The procedure is conducted under CT or ultrasound image-guidance
16070333|NCT02380430|Other|ambulatory surgery description|Medical questionnaire. Nausea and vomiting, pain, thromboprophylaxis description
16070334|NCT02380417|Procedure|paravertebral catheter placement|a thoracic paravertebral catheter was placed and connected to an elastomeric pump with a continuous infusion of 0.2% ropivacaine
16070335|NCT02380417|Drug|0.2% ropivacaine|0.2% ropivacaine was infused through the elastomeric device
16070336|NCT02380417|Device|Elastomeric pump|An elastomeric pump was connected to the paravertebral catheter
16070337|NCT02380404|Procedure|Implants-supported locators placement|Antibiotics will be prescribed 1 day before surgery and continued for 5 days. Three calibrated surgeons will place 4 NN or RN Roxolid tissue level implants. Two implants have to be placed in the ANT region (lateral or canine) and 2 implants in the POST region (as distal as possible). Angulated implant and placement of implant in the tuberosity region can be considered.
16070338|NCT02380365|Device|Electrocardiography|"Duration of intervention per patient/subject:
~5 min, observation 6 months"
16070339|NCT02380352|Drug|Amoxicillin|
16070340|NCT02380352|Drug|Placebo|Experimental arm must receive 5 days placebo after 5 days amoxicillin to preserve blinding.
16070341|NCT02380339|Behavioral|Psych-Educational session and virtual reality|Psych-Educational session and virtual reality
16070342|NCT02380339|Behavioral|Psych-Educational and BF sessions|Psych-Educational and BF sessions
16070343|NCT02380326|Procedure|Advanced endoscopic imaging modalities|Virtual bronchoscopic navigation, confocal laser endomicroscopy, micro CT
16070344|NCT02380313|Drug|Afuresertib|White of off-white round immediate release tablet for oral administration with unit dose strength of 50 mg and 75 mg to achieve the dosage level of 100 mg, 125 mg, 150 mg or 200 mg once daily.
16070345|NCT02380313|Drug|Enzalutamide|Opaque white to off-white capsule for oral administration with unit dose strength of 40mg to achieve dose level of 160 mg once daily.
16070346|NCT02380313|Drug|Abiraterone|White to off-white tablet for oral administration with unit dose strength 250 mg to achieve dose level of 1000 mg once daily.
16070347|NCT02380313|Drug|Prednisone|Continuous twice daily co administration of prednisone 5 mg as per labelled recommendation from United State Prescribing Information.
16070348|NCT02380287|Drug|humanized monoclonal antibody against human IL-17|
16070349|NCT02380261|Other|Systane® Lid Wipes|Commercially-marketed, individually-packaged, pre-moistened eyelid wipe for daily cleaning
16070350|NCT02380248|Other|Polyethylene Glycol, 0.4%, Propylene Glycol, 0.3% eye drops|
16070351|NCT02380235|Biological|PEG-somatropin|0.20mg/kg/w
16070352|NCT02380235|Biological|PEG-somatropin|0.12mg/kg/w
16070353|NCT02380222|Other|Interview|Single interview lasting approximately one hour
16070354|NCT02380209|Other|CEST MRI|CEST MRI will be performed on patients prior to surgical resection of their tumor
16070355|NCT02380183|Device|Civco Needle Guidance Device|Needle guidance device will be used while nerve block is performed.
16070356|NCT02380157|Drug|Kaleorid, 750mg (trade name), Potassium chloride (active substance)|4 weeks treatment with Kaleorid, 750mg, 3 tablets 3 times daily.
16070357|NCT02380157|Drug|Placebo|4 weeks treatment with Placebo tablets, 3 tablets 3 times daily.
16070358|NCT02380144|Other|Fresh orange fruit and pasteurized fruit juice|
16070359|NCT02380131|Drug|Oxaliplatin plus Capecitabine|A cycle: Oxaliplatin 130 mg/m2 D1 q3wk.E Capecitabine 2000mg/m2 D1-D14 q3wk、valuation for every two cycles.
16070360|NCT02380131|Drug|Herceptin|Herceptin 8mg/kg D1 q3wk for the first time,after Herceptin 6mg/kg D1 q3wk.Evaluation for every two cycles.Each of preoperative and postoperative chemotherapy was 3 cycles.
16070361|NCT02380118|Drug|Olanzapine|Intramuscular injection
16070362|NCT02380118|Drug|Haloperidol|Intramuscular injection
16070363|NCT02380118|Drug|Midazolam|Intramuscular injection
16070402|NCT02379767|Other|Structural magnetic resonance imaging|
16070403|NCT02379754|Drug|Gentamicins|Intratympanic installation of gentamicin 2-4 times depending on the efficacy of vestibular deafferentation
16070404|NCT02379741|Biological|ADC-1013|Agonistic human monoclonal IgG1 anti-CD40 antibody
16070364|NCT02380105|Behavioral|Counseling|Patients were informed of their condition and possible etiological factors contributing to the pathology. They were also educated about the postural rest position of the mandible and instructed to perform bilateral chewing and not overload the temporomandibular joint and masticatory muscles. Techniques to relieve pain and tension were taught to correct postural habits, food and sleep irregularities. The patients received written instructions for future reference, as a way of reinforcing the information provided during the initial consultation.
16070365|NCT02380105|Device|Interocclusal Appliances|Patients were treated using interocclusal appliances
16070366|NCT02380092|Device|LEGION™ Primary TKS with VERILAST™ Bearing Surface|All study subjects will be treated with LEGION™ Primary TKS with VERILAST™ Bearing Surface as per standard clinical practice.
16070367|NCT02380079|Drug|SCD-101|Administered as gelatin capsules
16070368|NCT02380066|Drug|Anyu Peibo|Placebo
16070369|NCT02380053|Drug|Bisoprolol|2 weeks of Bisoprolol 2.5mg daily then 2 weeks Bisoprolol 5mg daily
16070370|NCT02380053|Drug|Celiprolol|2 weeks of Celiprolol 200mg daily then 2 weeks Celiprolol 400mg daily
16070371|NCT02380040|Device|PPG|A PPG device will be applied to subjects in the right hand, left hand and one of the legs. Data will be recorded into a computer software
16070372|NCT02380027|Device|MRI|This will be a multi-parametric MRI of the prostate
16070373|NCT02380027|Procedure|MRI-targeted biopsy|This will be a biopsy targeted to suspicious areas on the MRI
16070374|NCT02380027|Procedure|TRUS-biopsy|This will be a standard 12 core trans-rectal prostate biopsy
16070375|NCT02380001|Drug|Dexketoprofen trometamol|White round pill containing 25mg of Dexketoprofen will be administered either prior/after to third molar surgery.
16070376|NCT02380001|Drug|Preoperative control|white round pill containing 25mg of placebo will be administered prior/after to third molar surgery. The placebo pill is identical to active dexketoprofen, in size and color
16070377|NCT02379988|Radiation|Verify radiation dose to heart and lung|This is a pilot study to determine whether the addition of inspiratory hold (breath holding) can decrease the radiation dose that the heart and lung receives for patients being treated for left sided breast cancer.
16070378|NCT02379975|Procedure|Non-surgical Periodontal Therapy|
16070379|NCT02379962|Other|no intervention|
16070380|NCT02379949|Behavioral|Virtual Reality Exposure Therapy|During virtual reality exposure therapy, a person encounters a feared stimulus (public speaking) in a computer-generated environment.
16070381|NCT02379949|Behavioral|Exposure Group Therapy|Exposure Group Therapy a behavioral treatment for social phobia. Participants face their fears by giving speeches to other group members.
16070382|NCT02379936|Device|The Neo Hilda|"This is a procedure that measures Lactate dehydrogenase in a fast and reliable way from only 10 microliter of blood. Using a small point of care card and a Smartphone for analysis.
~Point of care method"
16070383|NCT02379936|Procedure|Traditional evaluation|Traditional way of evaluation
16070384|NCT02379936|Device|iPhone 4S|
16070385|NCT02379923|Device|Crossing of Coronary Artery CTO|"Standard angiographic procedures will be followed for this study. The primary objective of this trial is to evaluate confirmation of placement of any guidewire beyond the chronic total occlusion (CTO) in the true vessel lumen in patients in which at least one Asahi series of guidewires and/or Corsair microcatheter were used.
~Procedure success will be defined as angiographic visualization of any guidewire in a position either distal or proximal to the occlusion depending on the route of access and the absence of in-hospital MACE.
~Other Name: ASAHI Corsair Microcatheter, ASAHI PTCA Guide Wires"
16070386|NCT02379910|Drug|AM1030-CREAM or placebo|
16070387|NCT02379897|Other|Diet|
16070388|NCT02379871|Other|Experimental Group|Supine mid-thoracic spinal manipulation to the T4/5 region
16070389|NCT02379871|Other|Sham Group|Subject will be positioned in supine identical to the experimental group, but no spinal manipulation will be delivered.
16070390|NCT02379858|Drug|Alvimopan|Alvimopan, 12mg, capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 after NGT removal until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal.
16070391|NCT02379858|Drug|Placebo|Placebo (sugar pill-will be the same size and color as the Alvimopan capsule), 12mg capsule. One 30 to 90 minutes before the scheduled start of surgery on Day 0, and twice daily beginning on POD 1 until hospital discharge or for a maximum of 7 days (up to 15 doses) of postoperative treatment. First post-operative dose begins after NGT removal.
16070392|NCT02379845|Device|NBTXR3|One intratumor implantation by injection
16070393|NCT02379845|Device|Radiation therapy|5 weeks/50 Gy (5 x 2 Gy by week)
16070394|NCT02379819|Device|Nucleus Hybrid L24 Implant|
16070395|NCT02379806|Drug|Enoxaparin|
16070396|NCT02379806|Drug|Placebo|
16070397|NCT02379793|Drug|LEO 80185 gel, vehicle, liquid paraffin|Each subject has all 3 treatments applied at the same time. Each treatment is applied once to 2 locations on the subject.
16070398|NCT02379780|Procedure|USG guided Subcostal TAP block|"Ultrasonography Assisted Subcostal TAP blockage: In plane technique was applied and 22 G needle (BRAUN Stimuplex D Plus 0,71*50 mm 22G*2) was used. Intravascular injection was eliminated after the passage of rectus sheath by negative aspiration. 0,5-1 ml local anesthetic was applied directly to confirm the right place. 10 cc bupivacain ( 0,5 % Marcain flacon, Astra Zeneca, Sweeden) and 5 cc lidocaine was injected to the site. The same procedure was applied to the opposite site.
~we investigated amount of TIVA during the operation, postoperative Visual Analog Scores and the time that the pain free time."
16070399|NCT02379780|Procedure|USG guided Paravertebral Block|"Ultrasonoraphy assisted Thoracic Paravertebral blockage application: In-plane or out-of-plane technique was used with stimuplex needle (BRAUN Stimuplec D Plus 0,71*50 mm 22 G* 2'', 15°). Popping sensation that was felt by the penetration of the internal intercostal membrane, guided to paravertebral space. Intravascular injection was eliminated by negative aspiration. 0,5 - 1 ml local anesthetic injection was administered to show the displacement of pleura downward that confirmed the place of the needle in the right place. Then 10 cc bupivacain (% 0.5 Marcaine® flacon, Astra Zeneca, Sweeden) and 5 cc lidocaine was injected to the site.
~we investigated amount of TIVA during the operation, postoperative Visual Analog Scores and the time that the pain free time."
16070400|NCT02379767|Device|Electroconvulsive therapy|
16070401|NCT02379767|Other|Positron emission tomography of the brain using [11C]harmine|
16070405|NCT02379728|Device|PrenaBelt|"The PrenaBelt (PB) is a belt-like, positional therapy (PT) device designed for pregnant women. While the PB does not prevent the user from lying on her back during sleep, it is expected to significantly decrease the amount of time a user spends supine via the mechanism of PT. PT is a simple, non-invasive, inexpensive, long-established, safe, and effective intervention for preventing people with positional-dependent snoring or obstructive sleep apnea from sleeping on their back - a position that exacerbates their condition.
~The PB is worn at the level of the waist or thorax. By design, the PB affects subtle pressure points on the user's back while supine, activating her body's natural mechanism to reposition itself to relieve discomfort, thereby reducing the amount of time spent supine."
16070406|NCT02379728|Device|Body Position Sensor|The Body Position Sensor (BPS) is for research purposes only. The BPS can be securely integrated into a pocket on the PrenaBelt (PrenaBelt with BPS Arm) or sham-PrenaBelt (Control with BPS Arm). The BPS is a small, electronic data acquisition device. The BPS uses a three axes accelerometer to detect orientation of the PrenaBelt, and thus the user (right, left, prone, supine), in three-dimensional space. The accelerometer data is collected continually with time stamping and stored on the BPS hard drive and can be accessed via connecting it to a computer. The BPS is not expected to affect the body position of the user.
16070407|NCT02379728|Device|sham-PrenaBelt|The PrenaBelt can be easily converted into a sham-PrenaBelt for research purposes by removing the hard balls from its pockets or exchanging these hard balls for soft balls so it cannot provide pressure points, i.e., positional therapy function. The sham-PrenaBelt looks, fits, and feels like the PrenaBelt but cannot provide positional therapy.
16070408|NCT02379715|Drug|Remifentanil|
16070409|NCT02379715|Drug|Desflurane|
16070410|NCT02379702|Other|Metabolic Syndrome|This study will provide important information on the social and economic dimensions of metabolic syndrome
16070411|NCT02379689|Drug|Injectable placental tissue extract called BioDGenesis (Active Product)|
16070412|NCT02379689|Drug|Placebo|
16070413|NCT02379676|Drug|Ticagrelor|Ticagrelor 90mg twice daily for 30 days
16070414|NCT02379676|Drug|Clopidogrel|Clopidogrel 75mg once daily for 30 days
16070415|NCT02379663|Drug|Rivaroxaban|Rivaroxaban was taken orally in a dosage of 10mg once daily
16070416|NCT02379663|Drug|Enoxaparin|Enoxaparin was injected subcutaneously in a dosage of 40mg once daily
16070417|NCT02379663|Other|Normal saline|subcutaneous injection of 1 cc of normal saline once daily
16070418|NCT02379650|Drug|Hydroxychloroquine (HCQ)|
16070419|NCT02379650|Drug|Placebo|
16070420|NCT02379637|Drug|N-acetylcysteine|
16070421|NCT02379637|Drug|Placebo|
16070422|NCT02379624|Drug|pectin|Pectin, a representative diety fibre, is a gelatinous substance derived from the cell walls of fruits and some plants and contains galacturonan, consisting of mostly long-chain D-galacturonic acids combined into units by α-1,4 linkages. As a kind of soluble dietary fiber, pectin has been proved of controlling glucose and blood lipids. It slows rapid infusion of the liquid meal into the gut by delaying gastric emptying.
16070424|NCT02379598|Dietary Supplement|Aminoacid based formula|Formula based on aminoacid
16070425|NCT02379598|Dietary Supplement|Hydrolyzed whey formula|Formula based on hydrolyzed whey protein
16070426|NCT02379585|Drug|Doxorubicin|doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 2 weeks for four cycles followed by paclitaxel (T) 75 mg/m2 every 2 weeks for four cycles (dose-dense AC + T).20
16070427|NCT02379585|Drug|cyclophosphamide|doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 2 weeks for four cycles followed by paclitaxel (T) 75 mg/m2 every 2 weeks for four cycles (dose-dense AC + T).20
16070428|NCT02379585|Drug|paclitaxel|For patients with HER2 negative breast cancer: doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 2 weeks for four cycles followed by paclitaxel (T) 75 mg/m2 every 2 weeks for four cycles (dose-dense AC + T).20
16070429|NCT02379585|Drug|docetaxel|For patients with HER2 positive breast cancer: docetaxel (T) 75 mg/m2 every 3 weeks for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent 3 cycles), Pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery. For patients who do not achieve pCR, adjuvant chemotherapy with doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 3 weeks for four cycles will be given, followed by trastuzumab 6 mg/kg every 3 weeks to complete 1 year of treatment. For patients with pCR, only trastuzumab 6 mg/kg every 3 weeks will be given adjuvantly to complete 1 year of treatment (TPH + AC).21
16070430|NCT02379585|Drug|Trastuzumab|docetaxel (T) 75 mg/m2 every 3 weeks for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent 3 cycles), Pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery. For patients who do not achieve pCR, adjuvant chemotherapy with doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 3 weeks for four cycles will be given, followed by trastuzumab 6 mg/kg every 3 weeks to complete 1 year of treatment. For patients with pCR, only trastuzumab 6 mg/kg every 3 weeks will be given adjuvantly to complete 1 year of treatment (TPH + AC).21
16070431|NCT02379585|Drug|Pertuzumab|docetaxel (T) 75 mg/m2 every 3 weeks for four cycles. Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent 3 cycles), Pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery. For patients who do not achieve pCR, adjuvant chemotherapy with doxorubicin (A) 60 mg/m2 plus cyclophosphamide (C) 600 mg/m2 every 3 weeks for four cycles will be given, followed by trastuzumab 6 mg/kg every 3 weeks to complete 1 year of treatment. For patients with pCR, only trastuzumab 6 mg/kg every 3 weeks will be given adjuvantly to complete 1 year of treatment (TPH + AC).21
16070434|NCT02379559|Behavioral|Exercise|For the first 12-weeks, participants will come to our community based research office for up to 50 min/session, 3-days/week of supervised exercise. Exercise duration will increase from 75 min/wk at week 1 to 150 min/wk by week 4. Thereafter, men will maintain 150 min/wk of moderate-intensity physical activity.
16070435|NCT02379559|Behavioral|Attention Control|We will provide weekly healthy lifestyle tips via text messages, and will include tips such as managing stressors in life and getting better sleep.
16070436|NCT02379546|Drug|Desflurane|Desflurane will be used to maintain the anesthesia and the dose of desflurane will be adjusted according to the Bispectral İndex Monitoring
16070437|NCT02379546|Device|Bispectral index monitoring|Bispectral index monitoring (BIS XP, A-2000, VERSİON 3.31, Aspect Medical Systems, Newton, Mass, USA)will be used to determine the depth of anesthesia
16070438|NCT02379533|Other|Aerobic exercise|
16070439|NCT02379520|Genetic|HPV Specific T Cells|"Dose escalation study with 5 dose levels: DL1-1×10^7 cells/m2, DL2-3×10^7 cells/m2, and DL3-1×10^8 cells/m2, DL4- 2 to 3×10^8 cells/m2, DL5- 0.8 to 1×10^9 cells/m2
~Group A -HPVST cells Group B -lymphodepletion & nivolumab & HPVST cells.
~First, treatment in Group A will be completed for DL1 and DL2. Only if DL2 in Group A proves safe, Group B will be treated on DL2, DL3, DL4, and DL5.
~Group A will be treated at DL3, DL4, and DL5 only if there is excessive toxicity in cohorts treated with lymphodepletion.
~HPVSTs will be given by IV injection over 1-10 minutes through a peripheral or a central line on day 0.
~If patients have clinical benefit (as determined by symptoms, physical exam or radiological studies) & no significant toxicities, they may get up to 5 repeat infusions (for max total of 6 infusions) of HPVSTs at or below the same dose level."
16070440|NCT02379520|Drug|Cytoxan|500mg/m^2/day x 3 days (on days -4, -3 and -2)
16070441|NCT02379520|Drug|Fludarabine|30mg/m^2/day x 3 days (on days -4, -3, and -2)
16070442|NCT02379520|Biological|Nivolumab|240mg every 2 weeks (+/- 3 days) starting on day -1
16070443|NCT02379507|Other|DEC033 Study Product|Apply twice daily
16070444|NCT02379481|Dietary Supplement|NS 550mg|
16070445|NCT02379481|Dietary Supplement|NS 1100mg|
16070446|NCT02379481|Dietary Supplement|placebo|
16070447|NCT02379468|Drug|Pedyphar Ointment|
16070448|NCT02379468|Drug|Panthenol|Ointment
16070449|NCT02379455|Other|Comprehensive drug review|1) Geriatric assessment including medical history, physical examination, supplementary tests. The geriatric work-up will be aimed at evaluating whether current medications are indicated, whether the relevant conditions are satisfactorily compensated, whether the dosages are appropriate, whether the patient has symptoms that may in reality be adverse drug effects, and whether drug-drug interactions or drug-disease interactions are likely to occur. 2) Conference with common drug review. The project physician and the family physician will discuss the patient's drug list systematically. 3) Individualized clinical follow-up depending on the medication changes that have been done.
16070450|NCT02379442|Biological|MSC|MSC are an adherent, fibroblast-like cell population found in the bone marrow. Allogeneic MSC for treatment can be grown from bone marrow aspirates or biopsies of normal donors.
16070451|NCT02379416|Drug|Nilotinib + Paclitaxel|The BCR-Abl kinase inhibitor nilotinib demonstrated greater than additive activity in combination with the anti-tubulin agent paclitaxel in preclinical xenograft models, justifying the clinical evaluation of this combination for its antitumor activity
16070452|NCT02379390|Drug|Cabazitaxel XRP6258|
16070453|NCT02379390|Drug|Ezalutamide|
16070454|NCT02379390|Drug|Abiraterone acetate|
16070455|NCT02379390|Drug|Prednisone|
16070456|NCT02379377|Biological|Fluorine F 18 L-glutamate Derivative 18F-FSPG|Undergo 18F-FSPG PET scan
16070457|NCT02379377|Biological|Carbon C 11 Acetate|Undergo 11C-acetate PET scan
16070458|NCT02379377|Procedure|Positron Emission Tomography|Undergo 18F-FSPG, 11C-acetate, or 18F-FDG PET
16070459|NCT02379377|Other|Laboratory Biomarker Analysis|Correlative studies
16070460|NCT02379377|Biological|Fluorine F 18 2-deoxy-2-(18F)fluoro-D-glucose|Undergo 18F-FDG PET scan
16070461|NCT02379364|Device|Diacutaneous Fibrolysis|Diacutaneous Fibrolysis is a non invasive physiotherapeutic technique applied by means a set of metallic hooks having the advantage of allowing a deeper and more precise application, which could not be achieved manually
16070462|NCT02379351|Device|In-Home Non-Stress Test Device|Airstrip® Sense4Baby™
16070463|NCT02379338|Drug|[18F]Fluortriopride|All subjects will receive a [18F]Fluortriopride PET/CT scan
16070464|NCT02379325|Behavioral|Lets Quit|"Five tracks were created including Not Ready, Beginner, Advance, Relapse, and Distraction. The Distraction track was combined with all of the other remaining 4 tracks. It was aimed as a distraction (as the name indicated) method to lighten the participants mood. It consisted of general information such as sports, fashion, dining, movies, and travelling."
16070465|NCT02379325|Behavioral|pamphlets material|Given pamphlets material on smoking and complication
16070466|NCT02379312|Dietary Supplement|Very low energy aerated beverage|
16070467|NCT02379312|Dietary Supplement|Normal energy aerated beverage 1|
16070468|NCT02379312|Dietary Supplement|Normal energy aerated beverage 2|
16070469|NCT02379312|Dietary Supplement|Normal energy aerated beverage 3|
16070470|NCT02379299|Device|DiaCon dual-hormone closed-loop glucose control algorithm|Dual-hormone closed-loop glucose control
16070471|NCT02379299|Device|DiaCon single-hormone closed-loop glucose control algorithm|Single-hormone closed-loop glucose control
16070472|NCT02379286|Other|Investigation|Investigation of relationships between French teenagers' attitudes and beliefs towards alcohol and tobacco products and the degree to which they watch and relate to television series and music videos
16070473|NCT02379273|Device|Nucleus Hybrid L24 Implant|Subjects have already been implanted with the Nucleus Hybrid L24 implant.
16070474|NCT02379260|Other|Interview with a sociologist|
16070475|NCT02379247|Drug|BYL-719 (alpelisib)|Oral PI3K inhibitor
16070476|NCT02379247|Drug|Nab-paclitaxel|IV taxane
16070728|NCT02377271|Drug|bosentan|treatment by bosentan or placebo is randomized , 125 mg twice a day
16070477|NCT02379234|Other|simulation|Nurses received, in addition to the conventional formation (as in the control arm), a set of 3 high-fidelity simulation sessions. Each session lasted 1 to 2 hours, used high fidelity mannequin and CVVH generator and took place in an ICU room environment. For each session, a specific scenario was designed, the session began with a briefing and ended with a debriefing, based on video recording.
16070478|NCT02379221|Drug|Injectable|20% benzocaine gel, 2% lidocaine, 1:100k epinephrine nerve block injection
16070479|NCT02379221|Drug|Topical|4% Topicaine gel
16070480|NCT02379195|Drug|Cyclophosphamide|Cyclophosphamide 60 mg/kg are administered i.v on day -7 and -6
16070481|NCT02379195|Drug|Fludarabine|Fludarabine 25 mg/m2 are administered i.v on day -5 to -1
16070482|NCT02379195|Biological|TIL infusion|The maximum number of expanded TILs are infused over 30-45 min on day 0
16070483|NCT02379195|Drug|Interleukin-2|Interleukin-2 are administered as a continuous i.v. infusion in a decrescendo regimen (18 MIU/m2 IL-2 over 6 hours, 18 MIU/m2 IL-2 over 12 hours, 18 MIU IL-2 over 24 hours followed by 4.5 MIU/m2 IL-2 over another 24 hours for three days)
16070484|NCT02379195|Drug|Peginterferon alfa-2b|Peginterferon alpha-2b, 3 microgram/kg are administered as subcutaneous injection on day -2, day 7 and day 14.
16070485|NCT02379182|Behavioral|standard clinical care|adaptation of fluids, diet and oral hygiene recommendations, and postural and swallowing maneuvers training if necessary
16070486|NCT02379182|Device|transcutaneous electrical stimulation at sensory level|The treatment procedure will consist of the application, at rest, of 80 Hz of transcutaneous electrical stimulus (biphasic, 700 µs) using VitalStim device (Chattanooga Group, Hixson, TN, USA), 2 sessions of 1 hour per day the first week, and 1 hour per day the next week. Sessions will be applied from Monday to Friday for two weeks. Treatment intensity will be set to 75% of motor threshold and electrode placement, thyro-hyoid (placement 3a described in the VitalStim Certification Program). The motor threshold will be determined by triplicate, as the intensity level at which the patient reports a grabbing or pulling sensation and confirmed by the clinician. Every 10 min, the patient will be asked if the initial sensation is maintained and, if necessary, treatment intensity will be re-adjusted.
16070487|NCT02379182|Device|transcutaneous electrical stimulation at motor level|The treatment procedure will consist of the application, at rest, of 80 Hz of transcutaneous electrical stimulus (biphasic, 700 µs) using VitalStim device (Chattanooga Group, Hixson, TN, USA), 2 sessions of 1 hour per day the first week, and 1 hour per day the next week. Sessions will be applied from Monday to Friday for two weeks. Treatment intensity will be set to the motor threshold and electrode placement, supra-hyoid. The motor threshold will be determined by triplicate, as the intensity level at which the patient reports a grabbing or pulling sensation and confirmed by the clinician. Every 10 min, the patient will be asked if the initial sensation is maintained and, if necessary, treatment intensity will be re-adjusted.
16070488|NCT02379169|Dietary Supplement|Sea buckthorn oil & lutein|Standardised sea buckthorn seed and pulp oil complemented with lutein
16070489|NCT02379169|Dietary Supplement|Placebo|Triglycerides of medium chain fatty acids
16070490|NCT02379156|Drug|Midodrine Hydrochloride|Midodrine hydrochloride is an approved medication used to treat low blood pressure. We are using a standard dose of 10 mg (tablet) only one time to determine if the vascular-constricting effects of this drug will help keep warm blood closer to the body's core and improve the ability to maintain Tcore in a cool environment (off-label use). A physician will administer the drug once before the cool thermal challenge in subjects with tetraplegia only (Visit 2).
16070491|NCT02379156|Other|Cool Temperature|Subjects will be exposed to a routinely encountered cool temperature (64° F) for up to to 2 hours depending on the vital signs (BP, HR, Tcore) and tolerance (comfort).
16070492|NCT02379143|Other|interview method: self report form|the responses about participants perception, behavior pattern and attitude were recorded on the self report form
16070493|NCT02379130|Behavioral|Family Nurture Intervention|The intervention begins with Block play. The child will be asked to play blocks with the mother during a eight minute video acquisition which will be coded for mother child interaction analysis. At the end of the video period the child will sit on the mother's lap. The pair will be asked to talk and play with each other as they customarily do. If the child becomes restless the mother will be coached by the nurture specialist to further engage the child with soothing and calming; the mother will be helped to bring the child back into a calm state through sustained physical contact, comfort touch, soothing words, and eye contact. The mother will also be helped to verbally express her feelings toward her child and to tolerate her child's full range of feeling.
16070494|NCT02379130|Behavioral|Play and Nutrition Intervention|The intervention begins with Block play. The child will be asked to play blocks with the mother during a eight minute video acquisition which will be coded for mother child interaction analysis. At the end of the video period, the child and mother will play nutrition-focused games using the Healthy Habits for Life program designed by Michelle Obama.
16070495|NCT02379104|Device|ROTEM sigma|Group Healthy Volunteers: a blood sample is tested with ROTEM sigma Group Patients with expected coagulopathy: a blood sample is tested with ROTEM sigma and ROTEM delta in parallel
16070496|NCT02379091|Drug|Namilumab|Namilumab subcutaneous injection
16070497|NCT02379091|Drug|Placebo|Namilumab placebo-matching subcutaneous injection
16070498|NCT02379091|Drug|Methotrexate|Methotrexate tablets
16070499|NCT02379091|Drug|Folic/folinic acid|Folic/folinic acid tablets
16070500|NCT02379078|Other|Shared decision-making aid|The IP-SDM toolkit consists of an online shared decision-making aid, 1-page provider enabler, a provider training video,1-page patient enabler, and a patient training video.
16070501|NCT02379078|Other|Generic hard copy diabetes resources|A hard copy of the executive summary of the CDA CPG and postcard outlining online resources, CDA patient education pamphlet
16070502|NCT02379078|Other|Generic online diabetes resources|Provider- and patient-directed guideline dissemination tools (not incorporating SDM) publicly accessible from the CDA website
16070503|NCT02379065|Device|The Aerogen Aeroneb Solo©|
16070504|NCT02379065|Device|Phillips Respironic© mask|
16070505|NCT02379052|Drug|Dupilumab|
16070506|NCT02379052|Drug|Placebo|
16070548|NCT02378753|Biological|rVSVΔG-ZEBOV|The rVSVΔG-ZEBOV vaccine is comprised of a single recombinant VSV isolate (11481 nontypeable) modified to replace the gene encoding the G envelope GP with the gene encoding the envelope GP from ZEBOV (Kikwit, 1995 strain).
16070729|NCT02377271|Drug|placebo|treatment by bosentan or placebo is randomized
16070507|NCT02379026|Dietary Supplement|Protein Drink/Diet|1.2 - 1.5 g of protein per kilogram bodyweight will be consumed per day. One milk-based beverage high in dairy protein (50g of protein per 500ml bottle) will be consumed every day (post-workout on exercise days, before bed on non-exercise days). A 500kcal deficit diet will be prescribed based on the individual characteristics (eg weight, age, physical activity levels) of each participant.
16070508|NCT02379026|Behavioral|Exercise|Participants will enrol in a multimodal exercise program (with balance, flexibility, resistance and aerobic elements) 3 times a week, each lasting 1 hour.
16070509|NCT02379026|Dietary Supplement|Vitamin D3|1 tablet of Vitamin D3 (25 micrograms) will be taken on 3 non-consecutive days/ week to achieve a weekly intake of 75 micrograms.
16070510|NCT02379013|Procedure|Volunteer with MRI|functional MRI
16070511|NCT02379000|Drug|Triamcinolone Acetonide|Under sterile conditions an intravitreal injection of trimcinolone acetonide 4 mg was performed.
16070512|NCT02379000|Procedure|Transpupillary thermotherapy|We delivered TTT with an infrared diode laser adapted to a slit-lamp biomicroscope at a wavelength of 810 nm and beam diameters of 0.5, 0.8, 1.2, 2.0, or 3.0 mm using a contact lens and through a dilated pupil. Each TTT spot was applied for a duration of about 1 minute to achieve a grayish-white color on the surface of the tumor.
16070513|NCT02378974|Biological|Cordstem-ST|
16070514|NCT02378974|Biological|Placebo|
16070515|NCT02378961|Drug|VOX|100 mg tablet(s) administered orally once daily with food
16070516|NCT02378961|Drug|SOF/VEL|400/100 mg FDC tablet administered orally once daily with food
16070517|NCT02378948|Dietary Supplement|Liquid oral feeding|Liquid oral feeding (water, soup, porridge, nutritional supplements etc.)
16070518|NCT02378935|Drug|VOX|100 mg tablet(s) administered orally once daily with food
16070519|NCT02378935|Drug|SOF/VEL|400/100 mg FDC tablet administered orally once daily with food
16070520|NCT02378935|Drug|RBV|Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16070521|NCT02378922|Biological|Gene-Modified HIV-Protected Hematopoietic Stem Cells|Receive LVsh5/C46 (Cal-1) transduced CD34+ HSPC IV
16070522|NCT02378922|Other|Laboratory Biomarker Analysis|Correlative studies
16070523|NCT02378922|Other|Transplant Conditioning|Undergo high-dose chemotherapy or chemoradiotherapy
16070524|NCT02378909|Device|Electrical stimulation device.|In the intervention group, all participants will receive Geko device which will produce electrical stimulation to enhance wound healing. This is the non- invasive device, self adhesive, light and does not restrict the patient's movement. Wound will be measured at the beginning of the study (before the device is applied) and after the study is complete. Blood and wound tissue samples will also be taken pre and post electrical stimulation to observe the effect of electrical stimulation on wound healing in people with diabetes.
16070525|NCT02378896|Behavioral|Personalized Computer Program|Training with a personalized computerized inhibitory training program
16070526|NCT02378896|Behavioral|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT), consisting of Exposure and Ritual Prevention Therapy
16070527|NCT02378883|Device|Apollo™ Onyx™ Delivery Micro Catheter|
16070528|NCT02378870|Drug|Osteodex|Osteodex 3.0 mg/kg given every two week, maximum 13 times.
16070529|NCT02378870|Drug|Placebo|
16070530|NCT02378844|Device|gammaCore®-R|Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).
16070531|NCT02378844|Device|gammaCore®-R Sham|Subjects will be instructed to treat three times per day, 2 consecutive bilateral stimulations, upon waking, six to eight hours following the first daily treatment, and six to eight hours following the second daily treatment (one stimulation on the right side immediately followed by a second stimulation on the left side).
16070532|NCT02378818|Behavioral|Force task, preference task, discount task, learning task.|Force task, preference task, discount task, learning task.
16070533|NCT02378805|Drug|ACE-inhibitor|observational study!
16070534|NCT02378805|Drug|AT1-inhibitor|observational study!
16070535|NCT02378805|Drug|HMG-Coenzyme inhibitor (statin)|observational study!
16070536|NCT02378805|Drug|Spironolactone|observational study!
16070537|NCT02378805|Drug|Paricalcitol|observational study!
16070538|NCT02378792|Device|Vagus Nerve Stimulation|Vagus Nerve Stimulator
16070539|NCT02378779|Other|Questionary SF12 and PEDT (Premature Ejaculation Diagnostic Tool)|The SF-12 was designed to measure general health status from the patient's point of view (12 questions are asking to the patients) and the PEDT questionnaire is a self-assessment questionnaire to diagnose premature ejaculation (5 questions are asking to the patients).
16070540|NCT02378779|Other|Total attention|Total attention of the GP to approach the subject of premature ejaculation during all the consultation
16070541|NCT02378779|Other|Humour|Use the humour to approach the subject of premature ejaculation
16070542|NCT02378779|Other|Take the drama out|Take the drama out to approach the subject of premature ejaculation
16070543|NCT02378779|Other|Question about premature ejaculation|Question about premature ejaculation during the GP consultation
16070544|NCT02378779|Other|Symptoms of premature ejaculation|GP's observation about signs of premature ejaculation
16070545|NCT02378779|Other|Help to verbalize|Help for the patient to speak about premature ejaculation
16070546|NCT02378766|Behavioral|Website A|"Patients assigned to this arm will be invited to complete a web-based tailored intervention called TAVIE en santé (TAVIE : Traitement, Assistance Virtuelle Infirmière et Enseignement).
~TAVIE en santé is a web-based tailored multicomponent intervention addressing smoking cessation, physical activity and healthy eating. Each component consists of seven interactive computer sessions lasting 5-10 minutes. The sessions, hosted by a virtual nurse, aims to develop and strengthen skills required for behavior change."
16070547|NCT02378766|Other|Website B|Patients assigned to this arm will be invited to consult a validated list of five predetermined websites offering information about the health behavior they chose: being physically active, following a healthy diet or quitting smoking. These websites offers reliable information and their content were validated by experts.
16070608|NCT02378246|Dietary Supplement|Placebo|multivitamin tablets without iodine
16070549|NCT02378740|Drug|Saline|"The study drug (either ketamine or saline) will be administered from the beginning of anesthesia through the commencement of wound closure to provide the following dose of ketamine:
~0.5 mg/kg loading dose 8.3 mcg/kg/min (0.5 mg/kg/hr) infusion"
16070550|NCT02378740|Drug|Ketamine|"The study drug (either ketamine or saline) will be administered from the beginning of anesthesia through the commencement of wound closure to provide the following dose of ketamine:
~0.5 mg/kg loading dose 8.3 mcg/kg/min (0.5 mg/kg/hr) infusion"
16070551|NCT02378727|Device|Active: Comparator Loss Of Resistance Syringe|Lumbar epidural procedure utilizing Loss of Resistance Syringe
16070552|NCT02378727|Device|Experimental: CompuFlo® Epidural System|CompuFlo® Epidural is intended for use with an epidural needle for the verification of needle tip placement in the lumbar epidural space
16070553|NCT02378714|Drug|Varenicline|Participants will be randomly assigned to 12 weeks of either placebo or varenicline medication (1mg twice daily). Participants and research personnel will be blind to treatment assignment.
16070554|NCT02378714|Behavioral|BASC|"The goal of behavioral activation therapy is to increase engagement in rewarding activities, a problem for smokers with depression who find smoking especially rewarding and prefer it over many other traditionally rewarding activities, by reducing patterns of behavioral avoidance, withdrawal, and inactivity. In this study, behavioral activation will be integrated with standard behavioral smoking cessation treatment.
~Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions."
16070555|NCT02378714|Behavioral|Standard treatment|Standard behavioral smoking cessation treatment is an effective treatment for nicotine dependence. Treatment focuses on self-monitoring of smoking behavior, identifying smoking triggers and alternative trigger management strategies, relaxation, social support for non-smoking, and relapse prevention. Treatment will be delivered in eight 45-minute sessions over 12 weeks occurring weekly for the first four sessions and biweekly for the final four sessions.
16070556|NCT02378701|Behavioral|QUALMS-1 Questionnaire|Participants complete the QUALMS-1 during first treatment visit, and after 4th cycle of treatment or when treatment stops.
16070557|NCT02378701|Behavioral|FACT-An Questionnaire|Participants complete the FACT-An during first treatment visit, and after 4th cycle of treatment or when treatment stops.
16070558|NCT02378688|Drug|MT-1303|
16070559|NCT02378688|Drug|Placebo|
16070560|NCT02378675|Other|Blood draw|During the routine blood sampling, a 10ml plasma sample as well as a 10ml serum sample will be obtained, spinned and stored at -80°C until the final assessment of adipocytokines.
16070561|NCT02378662|Biological|MDGN201 TARGTEPO|MDGN201 TARGTEPO secreting EPO
16070562|NCT02378649|Drug|Sildenafil|Sildenafil administration in the cardiac ICU following Mitral Valve Surgery concomitant with best practice usual care
16070563|NCT02378649|Drug|Placebo|Placebo comparator concomitant with best practice usual care
16070564|NCT02378636|Device|600S|Monofocal Aspheric Intraocular Lens (IOL)
16070565|NCT02378623|Drug|Apixaban|Patients who meet the study eligibility criteria and consent for enrollment will be randomized in a 1:1 ratio to intervention with apixaban or control group with placebo. The randomization will be performed by a computer generated block randomization protocol. Randomization will be stratified according to pre-existing CIED (≥6 months) vs. new implantation (<6 months from date of implant), in order to ensure at least 25% of patients have longstanding lead placement.
16070566|NCT02378623|Drug|Placebo|Patients who meet the study eligibility criteria and consent for enrollment will be randomized in a 1:1 ratio to intervention with apixaban or control group with placebo. The randomization will be performed by a computer generated block randomization protocol. Randomization will be stratified according to pre-existing CIED (≥6 months) vs. new implantation (<6 months from date of implant), in order to ensure at least 25% of patients have longstanding lead placement.
16070567|NCT02378610|Other|Observation|Observation of the gut bacterial flora in high- and low-stressed individuals
16070568|NCT02378597|Behavioral|Behavioral: Resiliency Intervention|4 hour behavioral session including education in the relaxation response, education about stress and allostatic load, cognitive skills building, review of difficult encounters with patients.
16070569|NCT02378584|Other|embryo transfer|healthy blastocyst transfer in natural and hormonal cycle
16070570|NCT02378571|Behavioral|Medication adherence telemonitoring|The member of the study team will respond to adherence data using clinical judgment as they would if the information was obtained during clinical care. Specifically, when contacting nonadherent participants, the member of the study team will provide participants with feedback on their electronic adherence; will inquire about potential consequences of missed doses; and will assess and respond to reasons for missed doses.
16070571|NCT02378558|Device|MagneMarker|The MagneMarker system includes a magnetic clip the MagneMarker, a clip placement device the MagneJector, and a magnetic field detecting probe the MagneProbe. The MagneMarker and MagneJector are used by a radiologist during a breast localization procedure. The MagneProbe is used by a surgeon to locate the MagneMarker during breast excision.
16070572|NCT02378545|Drug|Oxygen|"On the Hyperoxia arm: Oxygen will be administered using a non-re-breathe oxygen mask applied over the face and nose.
~On the Normoxia arm: In many cases oxygen will not be administered. If required the minimum percentage required to reach the target saturations will be administered. In a majority of cases this will be via a venturi mask."
16070573|NCT02378532|Drug|Chloroquine|Three cohorts of 3 patients will receive chloroquine in escalating doses (3 dose levels: 200 mg up to 600 mg daily) during standard treatment (radiotherapy and temozolomide) for newly diagnosed GBM. Extra patients can be added to a cohort in case of dose limiting toxicity, resulting in a maximum of 6 patients per dose level. Based on the results of the DSMB an additional leven of 300mg was added.
16070574|NCT02378532|Radiation|Radiotherapy|Patients will receive megavoltage radiotherapy in a conventionally fractionated regimen of 59.4 Gy in 33 fractions in 6.5 weeks, using modern computer-based treatment planning and delivery techniques. Treatment should start within 6 weeks of surgery.
16070575|NCT02378532|Drug|Temozolomide|Patients will take TMZ 75 mg/m² po qd during the course of radiotherapy six adjuvant cycles of TMZ. After a 4 week break, patients will receive up to six cycles of adjuvant oral TMZ 150 - 200 mg/m² po qd for 5 days every 28 days. The starting dose is 150 mg/m² po qd. At the start of cycle 2 the dose will be escalated to 200mg/m2, if the CTC non-hematologic toxicity for cycle 1 is grade ≤2 (except for alopecia, nausea, and vomiting), absolute neutrophil count is ≥1.5 x 109/L and the platelet count ≥ 100 x 109/L.
16070576|NCT02378519|Behavioral|Web-prog, followed by CBT + PT|This arm of the single system experimental design starts with a baseline phase of 8 weeks where the subjects are introduced into to the interactive web-based self-help program. The baseline-period is followed by the intervention period which consists of a continued use of the interactive web-based self-help program, now with with cognitive behavioral therapy coaching in combination with individually tailored physiotherapy according to the person's needs for 16 weeks.
16070577|NCT02378519|Behavioral|Base, followed by Web + CBT + PT|The intervention consists of a interactive web-based selfadministrated program with cognitive behavioral therapy coaching in combination with tailored physiotherapy according to the person's needs for 16 weeks.
16070578|NCT02378506|Biological|etanercept|50mg subcutaneous, once weekly, 24 weeks
16070579|NCT02378493|Biological|Antibiofilmogramme|An Antibiofilmogramme (BioFilm Control) evaluates the capacity of a series of antibiotics to inhibit the growth of bacterial biofilms for a given bacterial isolate.
16070580|NCT02378480|Drug|Omadacycline|Injection for IV dosing; Tablets for oral dosing
16070581|NCT02378480|Drug|Linezolid|Infusion solution for IV dosing; Tablets for oral dosing
16070582|NCT02378467|Drug|7% Hypertonic Saline (HS)|Administered via inhalation twice daily for 48 weeks. The delivery system is a PARI Sprint Junior nebulizer with a PARI Baby face mask or mouthpiece driven by a PARI Vios® compressor.
16070583|NCT02378467|Drug|0.9% Isotonic Saline (IS)|Administered via inhalation twice daily for 48 weeks. The delivery system is a PARI Sprint Junior nebulizer with a PARI Baby face mask or mouthpiece driven by a PARI Vios® compressor.
16070584|NCT02378454|Device|"Comparison of two MBWN2 devices : EasyOne Pro Lab versus Exhalyzer D"|Healthy and Cystic Fibrosis participants will perform the same day MBWN2 tests in duplicate with each device.
16070585|NCT02378441|Drug|Atorvastatin 20mg and Metformin SR 750mg|co-administration of Atorvastatin 20mg and Metformin SR 750mg
16070586|NCT02378441|Drug|CJ-30056 20/750mg|fixed-dosed combination of Atorvastatin 20mg and Metformin SR 750mg
16070587|NCT02378428|Drug|MIBG|
16070588|NCT02378415|Drug|Ketamine|IV Bolus dose of ketamine dosed at 0.2mg/kg infused over 1-2 minutes.
16070589|NCT02378415|Drug|Placebo|Normal Saline Infusion
16070590|NCT02378402|Other|Proton (1H-) magnetic resonance (MR) spectroscopy|PRESS localized 1D MRS sequence was used on a 3-T MR system. The lipid resonances will be analyzed using the LC-Model algorithm, and a Cramer-Rao lower bound (CRLB) threshold of 50% was used as quality control. Resonances of fatty acid (FA, lipid resonances δ 0.9, 1.3 and 1.6 ppm) and polyunsaturated fatty acid (PUFA, lipid resonance δ 2.1 and 2.3, 2.8, 5.3 ppm) will be evaluated on MRS, with ratios normalized with total TG value.
16070591|NCT02378389|Drug|Pyrotinib/Pyrotinib with Docetaxel|Pyrotinib oral daily, 240 mg, 320 mg, 400 mg.... Docetaxel i.v. once every 21 days.
16070592|NCT02378376|Dietary Supplement|Arabinoxylan oligosaccharides|
16070593|NCT02378376|Dietary Supplement|Dietary fiber enriched bran|
16070594|NCT02378363|Other|Write, draw and interview|Child should write, draw cancer signifiance and after, they were interview by a school nurse about cancer signifiance.
16070595|NCT02378350|Device|Hemodialysis treatment (no specific device is defined)|
16070596|NCT02378350|Drug|Peritoneal Dialysis treatment (no specific drug is defined)|
16070597|NCT02378337|Other|Image quantify|Will be observed all patients who perform PET / CT examinations, independent of clinical indication, in nuclear medicine at Hospital Sao Rafael. Those who show interest in participating in the study, will be provided free and informed consent form (ICF) for your appreciation. This evaluation will serve for analysis and quantification of PET-CT images.
16070598|NCT02378324|Other|Screening without fee|All women in three districts in Gothenburg, Sweden, that were eligible for invitation in the regular screening program were individually randomized by computer program in two parallel arms 1:1.
16070599|NCT02378298|Drug|Rituximab|Rituximab (RTX) is a mouse-human chimeric antibody designed towards (CD20) pre B and mature B lymphocytes and that blocks B-cells activation without affecting the regenerating of B cells from stem cells or the plasma cells immunoglobulin production. Rituximab is used in the treatment of hematologic malignancies (B cells lymphoma, chronic lymphatic leukaemia, Waldenströms macroglobulinemia) and autoimmune diseases with B-cell involvement such as rheumatoid arthritis, thrombocytopenic purpura, SLE).
16070600|NCT02378298|Drug|Iv Methylprednisolone|Solumedrol is an intravenous glucocorticoid that are the gold standard in TAO. All patients start with 500 mg/weeks for 4 weeks. The response is evaluated and patients are randomised to non-responders or responders. The responders continues with the gold standard treatment that is another 500 mg solumedrol/ week in 2 weeks and then 250 mg/ week in 6 weeks.
16070601|NCT02378298|Drug|peroral methylprednisolone and Methotrexate|Peroral GC (starting with 30 mg and tapering down) is combined with 15-20 mg MTX /week to reduce the needed dose of steroids
16070602|NCT02378285|Device|ACP|ACP is prepared using the Autologous Conditioned Plasma (ACP®) device from Arthrex (Naples, Florida, USA), following the supplier instructions. 2 mL of ACP are transferred in a standard 2 mL injection syringe by a nurse. The standard 2 mL injection syringe is then given to the physician.The patient is installed on a table with his arm in supine position. A local subcutaneous anesthesia (2 ml of 1% lidocaine) is done just before the infiltration by the physician. The infiltration is then done guided by ultrasound.
16070603|NCT02378285|Other|Saline solution|2 mL of saline solution are placed in a standard injection syringe by a nurse. The syringe is then given to the physician. The patient is installed on a table with his arm in supine position. A local subcutaneous anesthesia (2 ml of 1% lidocaine) is done just before the infiltration by the physician. The infiltration is then done guided by ultrasound.
16070604|NCT02378272|Other|care manager for depression|District nurse (care manager for depression) providing clinical services ( in cooperation with GP) as patient information and education on patient's preferred treatment, development of care plan, assessment of patient's depressive symptoms and regular telephone contacts.
16070605|NCT02378259|Procedure|Laparoscopic Roux-en-Y gastric bypass|Bariatric surgery with Roux-en-Y gastric bypass as preferred option, possible laparoscopic Vertical Sleeve Gastrectomy
16070606|NCT02378259|Procedure|Intense conservative treatment|Intense medical treatment for obesity (behavioral treatment, dietary intervention, exercise, medication etc) 8 week period of Low Calorie Diet. Treatment intensity about 1 visit a month over 2 years
16070607|NCT02378246|Dietary Supplement|Iodine|We use multivitamin tablets one with 150 microgram iodine for Active comparator and one without iodine as placebo
16070609|NCT02378233|Dietary Supplement|iodine|The intervention is to give a multivitamin pill including 150 microgram iodine and compare with a multivitamin pill that is not including iodine.
16070610|NCT02378233|Dietary Supplement|Placebo|Patients are given a non-iodine containing multivitamin tablet
16070611|NCT02378220|Genetic|Pharmacogenetic testing|Pharmacogenetic testing via YouScript® Personalized Prescribing System
16070612|NCT02378207|Biological|H4:IC31|H4 contains Mtb antigens Ag85B and TB10.4
16070613|NCT02378207|Biological|H56:IC31|H56 contains Mtb antigens ESAT-6, and Rv2660c
16070614|NCT02378207|Biological|BCG|
16070615|NCT02378207|Biological|Control Sodium Chloride 0.9%|
16070616|NCT02378194|Drug|Placebo|24 weeks, once daily oral administration
16070617|NCT02378194|Drug|HD-003 (800mg/day)|24 weeks, once daily oral administration
16070618|NCT02378194|Drug|HD-003 (1600mg/day)|24 weeks, once daily oral administration
16070619|NCT02378181|Behavioral|Health Education Toolkit|An existing evidence-based toolkit intervention will be adapted and redesigned by a patient and provider team into an engaging, narrative graphic novel curriculum. The proven behavioral interventions will be augmented with health education material focused on MAT and HIV risk reduction. Together, these materials will comprise the Health Education Toolkit. The Health Education Toolkit (TK) will employ a shared decision making model to encourage 1) increased recovery engagement by patients, and 2) patient engagement in deciding whether to initiate and adhere to MAT.
16070620|NCT02378181|Behavioral|Treatment-as-usual|Treatment-as-usual will consist of the same number of counseling sessions as the experimental TK condition, but the counselors working with patients in this condition will not be equipped with the TK materials.
16070621|NCT02378168|Other|no intervention; retrospective study|
16070622|NCT02378155|Device|SenSmart Model X-100, Nonin Medical|Device to measure cerebral tissue oxygen saturation
16070623|NCT02378142|Drug|Pazopanib|
16070624|NCT02378129|Drug|Resin-modified glass ionomer cement Clinpro XT|Clinpro XT (3M ESPE, Minnesota, USA)
16070625|NCT02378129|Drug|Glass Ionomer cement Vidrion R|Vidrion R (SS White, Gloucester, UK)
16070626|NCT02378116|Procedure|Surgical closure of the left atrial appendage|When patients are randomized to surgical closure, the surgeon is informed to close the left appendage. Closure is documented by a member of the research group at the site.
16070627|NCT02378077|Procedure|Fat biopsy during scheduled abdominal surgery|Physical exam including blood work, an EKG and bioimpedance testing. An oral glucose tolerance test. Insulin infusion. Fat tissue biopsy during a scheduled abdominal surgery.
16070628|NCT02378077|Procedure|Fat Aspiration|Physical exam including blood work, an EKG and bioimpedance testing. An oral glucose tolerance test. Insulin infusion. Subcutaneous fat tissue biopsy.
16070629|NCT02378077|Dietary Supplement|Fish Oil Supplement|Fish Oil supplementation for three months.
16070630|NCT02378064|Drug|6-month treatment|
16070631|NCT02378051|Behavioral|Staying Strong with Schools Intervention|"On-Site Training to Raise Awareness about the Stress of Parental Deployment and Review Resources Helpful in Promoting military-connected children (MCC)'s Resilience. A 60-minute training will be delivered by our Liaison Trainer on-site to school professionals at the beginning of the school year.
~Training and supervision of the Resilience Support Liaison (RSL). In each school receiving the Staying Strong with Schools intervention, we will train the guidance counselor to take on the role of a RSL. The RSL will develop for each MCC an individual resilience support plan that will outline the specific intervention components that will be applied for him/her."
16070632|NCT02378051|Other|Waitlist Control|Receipt of an educational pamphlet outlining resources useful to support military-connected children distributed to all educators at the beginning of the school year.
16070633|NCT02378038|Drug|PNT2258|
16070634|NCT02378025|Behavioral|Yoga Group|A 10-week yoga course designed to treat pain.
16070635|NCT02378025|Behavioral|Pain Management Wellness Group|A 10-week behavioral therapy course designed to treat pain.
16070636|NCT02378012|Other|Computer-Assisted Intervention|Receive access to Netflix, Spotify, and Skype applications
16070637|NCT02378012|Other|Computer-Assisted Intervention|Receive iPad and instruction manuals.
16070638|NCT02378012|Other|Questionnaire Administration|Ancillary studies
16070639|NCT02377999|Drug|Picato|
16070640|NCT02377986|Behavioral|BIT+in-home decluterring|BIT Workshop + In-home decluttering practice
16070641|NCT02377986|Behavioral|In-Home Decluttering|In-home decluttering practice
16070642|NCT02377960|Behavioral|IMB model-based initiation of antihypertensive medication|1.An IMB model-based initiation of medication i.e. a nine-point check list to be fulfilled by physician and patient together when ordering the antihypertensive medication for the first time
16070643|NCT02377960|Behavioral|Tailored SMS-text message support|2.Tailored SMS-text message support for the first 12 months of medication. At the beginning (2 weeks), text messages are send on daily basis and focused on medications-reminders and coping with potential side-effects of medication. After that, text messages will be sent less often and the focus will change to keeping up with medication and reminding of importance of performing adequate home BP self-monitoring, achieving the BP target and attending clinical appointments.
16070644|NCT02377960|Behavioral|Usual care|Usual care
16070645|NCT02377934|Radiation|Cardiac Magnetic Resonance Imaging (MRI)|
16070646|NCT02377921|Drug|aceneuramic acid extended-release (Ace-ER)|tablets for oral use
16070647|NCT02377921|Drug|Placebo|tablets for oral use
16070648|NCT02377908|Other|Online Survey|Online questionaire submitted to experts in geriatrics in different European countries. 12-item survey.
16070649|NCT02377895|Drug|Nasapaque Nasal Solution|
16070650|NCT02377895|Drug|Placebo Saline Nasal Solution|
16070651|NCT02377869|Other|No intervantion|
16070652|NCT02377856|Drug|pegylated interferon alpha 2a, ribavirin|pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks
16070678|NCT02377661|Drug|Olmesartan medoxomil, amlodipine, hydrochlorothiazide|Up-titration of antihypertensive therapy with single pill combinations (comprising an angiotensin receptor blocker, calcium channel blocker and hydrochlorothiazide) in 4-week intervals if the target blood pressure of < 140/90 mmHg is not reached at the respective follow-up
16070730|NCT02377258|Other|Non Interventional|
16071148|NCT02374567|Drug|Fluoxetine|
16071149|NCT02374567|Drug|Citalopram|
16070653|NCT02377843|Behavioral|Participatory|"The participatory intervention is a 1-hour training to help clinicians improve their ability to make strong and effective recommendations for HPV vaccine, and address parental concerns regarding HPV vaccination. The training includes four components:
~Review of information on HPV vaccine, including effectiveness, safety, rationale for targeting adolescents ages 11-12, and low HPV vaccine coverage rates compared to Tdap and meningococcal vaccine
~Skills building on how to recommend HPV vaccine using a participatory communication strategy based in shared decision making
~Practice using the communication strategy via role play
~Discussion on applying the communication strategy to medical practice"
16070654|NCT02377843|Behavioral|Efficient|"The efficient intervention is a 1-hour training to help clinicians improve their ability to make strong and effective recommendations for HPV vaccine, and address parental concerns regarding HPV vaccination. The training includes four components:
~Review of information on HPV vaccine, including effectiveness, safety, rationale for targeting adolescents ages 11-12, and low HPV vaccine coverage rates compared to Tdap and meningococcal vaccine
~Skills building on how to recommend HPV vaccine using an efficient communication strategy based on first announcing the child is due for 3 vaccines
~Practice using the communication strategy via role play
~Discussion on applying the communication strategy to medical practice"
16070655|NCT02377830|Device|In-bed cycle ergometer (Restorative Therapies RT300 Supine)|
16070656|NCT02377830|Other|Routine physiotherapy|activities to assist with optimizing airway clearance and respiratory function, and, based on the patient's alertness and medical stability, activities to maintain or increase limb range of motion and strength, in- and out of bed mobility, and ambulation
16070657|NCT02377817|Device|PrenaBelt|"The PrenaBelt is a belt-like, positional therapy (PT) device designed specifically for pregnant women. While the PrenaBelt does not prevent the user from lying on her back or right side during sleep, it is expected to significantly decrease the amount of time she spends in these two positions via the mechanism of PT. PT is a simple, non-invasive, inexpensive, long-established, safe, and effective intervention for preventing people with positional-dependent snoring or obstructive sleep apnea from sleeping on their back - a position that exacerbates their condition.
~The PrenaBelt is worn at the level of the waist. By virtue of its design and position on the user's body, the PrenaBelt affects subtle pressure points on the back and right side of the user when she lies on her back or right side, respectively, activating her body's natural mechanism to spontaneously reposition itself to relieve discomfort, thereby reducing the amount of time she remains on her back or right side."
16070658|NCT02377817|Device|Sham PrenaBelt|The Sham PrenaBelt and PrenaBelt are the same device except the plastic balls are removed from the Sham PrenaBelt so it cannot provide pressure points.
16070659|NCT02377804|Other|Dry needling|Patients will receive deep dry needling with disposable stainless steel needles (0.3mm x 50mm) that will be inserted into the skin over taut bands of the spastic musculature of the shoulder area: upper trapezius, subscapularis, infraspinatus, and pect
16070660|NCT02377804|Other|Physical Therapy|Patients will receive 3 sessions, one per week, of 45min of physical therapy including mobilizations of the scapular region, manual therapies targeted to decrease muscle tone, neuromodulatory techniques for spasticity and proprioceptive exercises for the upper extremity
16070661|NCT02377804|Device|stainless steel needles (0.3mm x 50mm)|
16070662|NCT02377791|Genetic|SNP: CYP3A5 gene polymorphisms|Evaluate impact of CYP3A5*1/*1 vs CYP3A5*1/*3 or CYP3A5*3/*3
16070663|NCT02377778|Drug|Propofol|Propofol intravenous infusion for introduction and maintance of anaesthesia at doses 3-5mg depending on the total time needed for completion of oocyte retrieval
16070664|NCT02377778|Drug|Thiopental|Patients will receive thiopental in addition to fentanyl for introduction and maintanance of anaesthesia at doses 7mg. IF required patients will receive a repeat dose of 1-3mg of thiopental depending on the totla time needed to complete oocyte retrieval
16070665|NCT02377765|Device|Transcutaneous Stimulation|TPTNS through a TENS unit is a non-invasive technique, easily manageable by patients, which lacks some adverse side effects reported with the use of PTNS, such as bleeding and/or pain at the site of needle insertion. As the technique is self-administered, the associated costs might be substantially lower when compared to PTNS, which involves repeated Hospital appointments for maintenance therapy.
16070666|NCT02377765|Procedure|Percutaneus Stimulation|PTNS aims to stimulate the sacral nerve plexus (origin to the parasympathetic innervations to the bladder) through the afferent fibres of the posterior tibial nerve, a mixed nerve containing L5-S3 fibres (Slovak, Chapple and Barker, 2014). This is achieved by a needle electrode inserted above the medial malleolus. Interestingly, this anatomical area is known as acupuncture point Spleen6 (Sp6).
16070667|NCT02377752|Biological|Olaratumab|Administered IV
16070668|NCT02377752|Drug|Doxorubicin|Administered IV
16070669|NCT02377739|Other|non-invasive ventilation|patients will undergo a nocturnal non-invasive ventilation
16070670|NCT02377726|Behavioral|Alkoholhjälpen counselor support|Users will have access to counselor support through secure comments at the end of every module they complete in the self help program.
16070671|NCT02377726|Behavioral|eChange Alkoholhjälpen|An internet based intervention program (iCBT) consisting of 5 modules. Fully automated self-help
16070672|NCT02377726|Behavioral|Alkoholhjälpen|A swedish, open access website that includes information on alcohol, on how to find treatment and an internet discussion forum
16070673|NCT02377713|Drug|KHK6640|Single ascending dose administration
16070674|NCT02377713|Drug|Placebo|Single ascending dose administration
16070675|NCT02377700|Device|Xeltis Vascular Patch, Model COR-VP-001|The intended use of the Xeltis Vascular Patch, Model COR-VP-001 is to augment pulmonary artery and thereby improve hemodynamics by increasing blood flow to the lungs in patients with congenital pulmonary artery obstructions as an initial part of the staged procedure of a bidirectional cava-pulmonary anastomosis
16070676|NCT02377687|Other|observational study|
16070677|NCT02377674|Device|Vascular Graft, Model COR-VG-001|The intended use of the Xeltis Vascular Graft, Model COR-VG-001 is to create an extracardiac total cavopulmonary connection (EC-TCPC) connection to divert the venous blood from the inferior vena cava to the pulmonary arteries without passing through the morphologic right ventricle reducing the volume load on the functional single ventricle and thereby improving hemodynamics by minimizing the deleterious effects of ventricular hypertrophy.
16070726|NCT02377297|Procedure|Restoration with Maxxion R|The cavities will be restored with Maxxion R (FGM, Rio de Janeiro, BR).
16070727|NCT02377284|Other|Photograph|Add a photograph to a chef card.
16070679|NCT02377648|Device|Everolimus-Eluting Bioresorbable Vascular Scaffold (ABSORB)|Placement of bioresorbable vascular scaffold in presence of at least one critical angiographic de novo lesion (DS ≥70%) or a non-critical angiographic de novo lesion (50% ≤ DS <70%) associated with concomitant signs or symptoms of myocardial ischemia.
16070680|NCT02377635|Dietary Supplement|Anhydrous selenite|40 volunteer sufferers will be housed in a local private in-patient clinic where they will follow a fixed, communal diet consisting of drinking water and meals from their village. On a 6th day we will give a single dose of placebo (sodium chloride) or anhydrous sodium selenite (0.8mg selenium) labelled with a non-radioactive naturally occurring isotope (77Se), to distinguish it from selenium already in the body.
16070681|NCT02377635|Dietary Supplement|Sodium chloride|40 volunteer sufferers will be housed in a local private in-patient clinic where they will follow a fixed, communal diet consisting of drinking water and meals from their village. On a 6th day we will give a single dose of placebo (sodium chloride) or anhydrous sodium selenite (0.8mg selenium) labelled with a non-radioactive naturally occurring isotope (77Se), to distinguish it from selenium already in the body.
16070682|NCT02377622|Device|THERANOVA 400 dialyzer prototype AA|
16070683|NCT02377622|Device|THERANOVA 400 dialyzer prototype BB|
16070684|NCT02377622|Device|FX CorDiax 80 Dialyzer|
16070685|NCT02377622|Device|FX CorDiax 800 Dialyzer|
16070686|NCT02377609|Drug|Tacrolimus|oral
16070687|NCT02377570|Device|THERANOVA 400 dialyzer prototype AA|Hemodialysis
16070688|NCT02377570|Device|THERANOVA 400 dialyzer prototype BB|Hemodialysis
16070689|NCT02377570|Device|THERNOVA 400 dialyzer prototype CC|Hemodialysis
16070690|NCT02377570|Device|FX CorDiax 80 dialyzer|Hemodialysis
16070691|NCT02377557|Drug|Topical Steroids|
16070692|NCT02377544|Dietary Supplement|Probiotic|
16070693|NCT02377544|Other|Placebo|
16070694|NCT02377531|Other|Early glucose screen group|Main intervention is randomization: half of the participants will be randomized to undergo a 50 gram oral glucose load with a 1 hour serum glucose measurement as a screen for Gestational Diabetes mellitus at 12 to 18 weeks of pregnancy instead of standard 24 to 28 weeks of pregnancy
16070695|NCT02377531|Other|Standard glucose screen group|Main intervention is randomization: half of the participants will be randomized to undergo a 50 gram oral glucose load with a 1 hour serum glucose measurement as a screen for Gestational Diabetes mellitus at 24 to 28 weeks of pregnancy
16070696|NCT02377518|Radiation|Single source dual energy compted tomography (CT750HD, General Electric, USA) with Krypton as a gaseous contrast media|
16070697|NCT02377505|Device|On-Stimulation|"The surgical electrode implanted in target 1 (mPFC) or target 2 (NAcc) by a pulse generating device (Kinetra, Medtronic Inc) is on"
16070698|NCT02377505|Device|Off-Stimulation|"The surgical electrode implanted in target 1 (mPFC) or target 2 (NAcc) by a pulse generating device (Kinetra, Medtronic Inc) is off"
16070699|NCT02377492|Drug|Vasopressins|Either paracervical and intramyometrial or intramyometrial alone at time of abdominal myomectomy.
16070700|NCT02377479|Drug|Clomiphene|Taken for controlled ovarian hyperstimulation.
16070701|NCT02377479|Drug|Letrozole|Taken for controlled ovarian hyperstimulation
16070702|NCT02377466|Drug|Retosiban IV infusion|Retosiban for IV administration will be supplied as solution for infusion, consisting of a clear colorless solution of retosiban at a concentration of 15 milligram per milliliter (mg/mL).
16070703|NCT02377466|Drug|Placebo IV infusion|0.9% NaCl matched for the retosiban loading dose and continuous infusion rates
16070704|NCT02377427|Drug|Mepolizumab|Mepolizumab is supplied as 100 mg lyophilised cake in sterile vials for subcutaneous administration in upper arm or thigh. The vial will be reconstituted with sterile water for injection prior to individual use.
16070705|NCT02377414|Drug|Retosiban solution for Infusion|Retosiban will be supplied as clear, colorless IV solution for infusion in 5 mL vial with a unit dose strength of 15 milligrams per milliliter (mg/mL) (each 5 mL vial contains 75 mg retosiban), dosed at up to 300 mg over 48 h infusion
16070706|NCT02377414|Drug|Placebo|Placebo will be supplied as a clear, colorless IV solution for infusion with a unit dose strength of 0.9% sodium chloride (NaCl) normal saline
16070707|NCT02377401|Drug|Zanamivir|Zanamivir will be supplied as 10 mg/mL sterile clear, colorless, aqueous solution in 20 mL clear glass vials, each containing 200 mg zanamivir. Intravenous solutions will be prepared with normal saline.
16070708|NCT02377388|Drug|sitagliptin OR saxagliptin|sitagliptin OR saxagliptin tablets, 48(+-24) hours after the beginning of an AMI,and both arms in use of dual anti-platelet therapy (DAPT) .
16070709|NCT02377388|Drug|placebo|placebo tablets, 48(+-24) hours after the beginning of an AMI,and both arms in use of dual anti-platelet therapy (DAPT) .
16070710|NCT02377375|Procedure|Micro-assisted technique|Medtronic DBS lead 3391-28cm Medtronic electrode array microrecording 22670
16070711|NCT02377375|Procedure|Standard technique|Medtronic DBS lead 3391-28cm
16070712|NCT02377362|Drug|GLWL-01, Part A|Capsules administered orally, in 2 out of 3 periods
16070713|NCT02377362|Drug|Placebo, Part A|Capsules administered orally in 1 out of 3 periods
16070714|NCT02377362|Drug|GLWL-01, Part B|Capsules administered orally either once or twice daily for 27 days, with a single dose on Day 28
16070715|NCT02377362|Drug|Placebo, Part B|Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28
16070716|NCT02377362|Drug|GLWL-01, Part C|Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28
16070717|NCT02377362|Drug|Placebo, Part C|Capsules administered orally either once or twice daily for 27 days with a single dose on Day 28
16070718|NCT02377349|Biological|Boostrix™|One dose administered intramuscularly in the deltoid muscle of the non-dominant arm.
16070719|NCT02377349|Drug|Saline placebo|One dose administered intramuscularly in the deltoid muscle of the non-dominant arm.
16070720|NCT02377336|Drug|GS-6615|GS-6615 tablets administered orally
16070721|NCT02377336|Drug|Placebo|Placebo to match GS-6615 tablets administered orally
16070722|NCT02377323|Other|MACFIMS|Cognitive evaluation of 50 participants
16070723|NCT02377323|Other|MSQoL-54|Quality of life questionnaires
16070724|NCT02377297|Procedure|Restoration with Fuji IX|The cavities will be restored with Fuji IX (GC Europe, Leuven, BE).
16070725|NCT02377297|Procedure|Restoration with Vitro Molar|The cavities will be restored with Vitro Molar (DHL, Rio de Janeiro, BR).
16070731|NCT02377232|Behavioral|Decision Aid for Colon Cancer Screening|Paper decision aid describing different screening options for colon cancer
16070732|NCT02377232|Behavioral|Usual Care Outreach for Colon Cancer Screening|Patients overdue for colon cancer screening are contacted and outreach is performed in an effort to schedule colonoscopy
16070733|NCT02377219|Other|hormonal and blood analysis|
16070734|NCT02377206|Other|ADAS-Cog evaluation|[18F]DPA-714 PET imaging
16070735|NCT02377193|Drug|Simulect|"Simulect IV 40 mg/day D0 and D4
~and oral use Tacrolimus 0.1 mg/ kg/ day + Myfortic 720 to 1440mg + Corticosteroids 5mg"
16070736|NCT02377193|Drug|ATG Fresenius|Simulect IV 40 mg/day D0 and D4 and oral use Tacrolimus 0.1 mg/ kg/ day + Myfortic 720 to 1440mg + Corticosteroids 5mg
16070737|NCT02377180|Procedure|Intramuscular capsaicin injection|Intramuscular injection of capsaicin: 50 mcg/0.5 ml
16070738|NCT02377180|Procedure|Suprascapular nerve block|"Injection of capsaicin 50 mcg/0.5 ml into the supraspinatus or trapezius muscle in randomized order, followed by suprascapular nerve block (ultrasound-guided) using Lidocaine 1%; nerve block is expected to be effective only in pain arising from the supraspinatus muscle. Trapezius pain serves as control condition.
~Evaluates the diagnostic validity of suprascapular nerve block for muscle pain."
16070739|NCT02377180|Procedure|Local anesthetic infiltration|Injection of capsaicin 50 mcg/0.5 ml into the supraspinatus muscle in two different sessions; suprascapular nerve block in one session and intramuscular local anesthetic infiltration in one session (in randomized order) using Lidocaine 1%; the aim is to investigate which procedure provides faster and more efficient pain relief. Compares effectivity of suprascapular nerve block vs. intramuscular local anesthetic infiltration.
16070740|NCT02377167|Procedure|Tracheostomy|Tracheostomy is performed as percutaneous dilatative tracheostomy with tracheostomy kit by neurointensivists whenever possible. If anatomically or otherwise indicated, surgical tracheostomy is applied.
16070741|NCT02377154|Device|Slit lamp|Examination of cornea
16070742|NCT02377154|Device|Autorefractor|Measurement of refraction
16070743|NCT02377154|Device|IOLMaster 500|Measurement of axial length and white-to-white distance; Keratometry; IOL calculation
16070744|NCT02377154|Device|Pentacam HR|Measurement of white-to-white distance; Keratometry
16070745|NCT02377154|Device|LenStar LS900|Measurement of axial length and white-to-white distance; Keratometry; IOL calculation
16070746|NCT02377154|Device|VERION Image Guided System|Measurement of white-to-white distance; Keratometry; IOL calculation with axial length value of IOLMaster 500
16070747|NCT02377141|Procedure|Endoscopic Variceal Band Ligation|Standard care: Endoscopic application of rubber bands to varices (swollen veins) in the oesophagus this is repeated on 4-5 occasions until the varices are eradicated.
16070748|NCT02377141|Procedure|Transjugular Intrahepatic Porto-Systemic Stent Shunt|Within 72 hours of the initial endoscopy to apply bands to the bleeding varices the patient undergoes a Transjugular Intrahepatic Porto-Systemic Stent Shunt (TIPSS) procedure. Under x-ray guidance a shunt is created in the liver between the hepatic vein and portal vein via a catheter introduced via the jugular vein. It may require a check once or twice per year to ensure it remains patent.
16070749|NCT02377128|Procedure|Bilateral salpingectomy|Surgical bilateral removal of fallopian tubes (not involving ovaries)
16070750|NCT02377128|Procedure|Tubal ligation|Bilateral ligation of fallopian tubes (not involving ovaries)
16070751|NCT02377115|Other|Tablet computer application|Preoperatively, all study participants (entire cohort) will perform in the self-administered tablet computer-based tool to assess the risk of developing POD.
16070752|NCT02377102|Procedure|Physical Therapy|12 weeks of supervised physical therapy.
16070753|NCT02377089|Device|Trigeminal Nerve Stimulation|Subjects will be randomized to treatment with either active or sham TNS for a period of eight weeks. The programming will be set by an individual who has no contact with subjects to deliver TNS in a double-blind manner (n=37 in each group) at the active frequency of 120 Hz. TNS will be performed for approximately 8 hours each night, a protocol that subjects found acceptable in the pilot work.
16070754|NCT02377089|Device|Placebo|Subjects will be randomized to treatment with either active or sham TNS for a period of eight weeks. The programming will be set by an individual who has no contact with subjects to deliver TNS in a double-blind manner (n=37 in each group) at the sham frequency of 0 Hz. TNS will be performed for approximately 8 hours each night, a protocol that subjects found acceptable in the pilot work.
16070755|NCT02377076|Dietary Supplement|Dietary calcium supplementation|Dietary calcium supplementation as milk powder
16070756|NCT02377076|Dietary Supplement|Control|Control (Whey protein, vitamin D, sugar and salt)
16070757|NCT02377063|Dietary Supplement|Pressed Juice|Subjects will be taking vegetable/fruit juice supplementation for 3 days. Blood, urine and stool samples will be collected at baseline, day 4 and day 17.
16070758|NCT02377050|Other|Higher Volume Feeding Goal|feeding volume goal of 180-200 ml/kg/day
16070759|NCT02377037|Other|Metabolic cost and HR associated with distinct postural behaviors|The order of the three conditions will be randomly assigned and all will be undertaken in laboratory settings. Before engaging in the experimental conditions participants will perform anthropometric and body composition assessments and also the resting EE evaluation. All evaluations will be performed at one time only, starting at 7:00 am in the morning after an overnight fast
16070760|NCT02377024|Dietary Supplement|TF 600mg|
16070761|NCT02377024|Dietary Supplement|TF 1200mg|
16070762|NCT02377024|Dietary Supplement|placebo|
16070763|NCT02377011|Behavioral|Problem solving cognitive behaviour therapy (PS CBT)|
16070764|NCT02376998|Device|Valiant™ endoluminal procedure|"Thoracic endovascular aortic repair with Endoluminal stent-graft placement (Valiant™ endoluminal stent-graft systems (Medtronic Inc., Santa Rosa, CA, USA) will be performed as follows:
~The diameter of the stent graft will be calculated from the largest diameter of the proximal/distal neck with an oversizing factor of 10-20%. The procedures will be done with local or general anaesthesia in case of unstable pre-operative hemodynamic conditions.
~After the procedure will be completed, a digital subtraction angiography and echocardiography with color-flow mapping were performed to verify the correct positioning of the stent and to detect any primary endoleak."
16070765|NCT02376985|Procedure|Oral management|
16070766|NCT02376985|Drug|Everolimus|
16070767|NCT02376972|Drug|RIFAXIMIN VAGINAL TABLET 25 MG|RIFAXIMIN VAGINAL TABLET 25 MG O.D./5 DAYS INTRAVAGINALLY
16070768|NCT02376972|Drug|RIFAXIMIN VAGINAL TABLET 100 MG|RIFAXIMIN VAGINAL TABLET 100 MG O.D./5 DAYS INTRAVAGINALLY
16070769|NCT02376972|Drug|PLACEBO VAGINAL TABLET|PLACEBO VAGINAL TABLET O.D./5 DAYS INTRAVAGINALLY
16070770|NCT02376972|Drug|METROGEL VAGINAL|METROGEL VAGINAL O.D./5 DAYS INTRAVAGINALLY
16070771|NCT02376959|Behavioral|"Spiritist passe"|"For a period of 5 min per week, the volunteers will remain in the supine position with their eyes closed, in a quiet environment with controlled light and temperature.
~The applied intervention will consist of placing both hands in the classic Spiritist passe position for the stipulated 5-min period. Spiritist passe will be applied by volunteers with training and experience of more than two years with the technique."
16070772|NCT02376946|Device|ActiPatch(TM)|Assigned by randomization, this study group will be comprised of subjects that receive the PEMF ActiPatch(TM) treatment for postoperative management of pain and edema.
16070773|NCT02376946|Device|Placebo|Assigned by randomization, this control group will be comprised of the subjects that receive a placebo patch as treatment for postoperative management of pain and edema.
16070774|NCT02376933|Procedure|Vertebroplasty|Under imaging guidance, a fractured vertebral body is stabilized with injected bone cement.
16070775|NCT02376933|Radiation|Radiotherapy|Radiotherapy of metastatic lesions to the spine.
16070776|NCT02376907|Procedure|Biliary drainage|EUS-BD or ERCP
16070777|NCT02376881|Drug|Erythropoietin|20,000 IU epo IV infusion in 100 ml normal saline in 2 hr for 3 successive days
16070778|NCT02376881|Other|placebo|100 ml normal saline in 2 hr for 3 successive days
16070779|NCT02376868|Device|3D OCT-1 Maestro|OCT machines used for diagnostic purposes
16070780|NCT02376868|Device|iVue|OCT machines used for diagnostic purposes
16070781|NCT02376855|Other|eConsult|"An electronic consultation or eConsult is a secure message consult that allows specialists to provide advice on cases without seeing a patient face to face. They contain a reason for consult, any relevant tests, procedures or reports. The responsibility lies with the primary care provider to act, or not act on the advice as they deem fit."
16070782|NCT02376842|Behavioral|Severe sepsis early warning best practice alert|
16070783|NCT02376842|Behavioral|Standard care|
16070784|NCT02376829|Device|Invisalign System|The Invisalign® System is indicated for the alignment of teeth during orthodontic treatment of malocclusion
16070785|NCT02376816|Biological|rAAVrh74.MCK.micro-Dystrophin|"Recombinant adeno-associated virus carrying a truncated micro dystrophin transgene under control of a muscle specific MCK promoter."
16070786|NCT02376803|Drug|Warfarin|Morning vs Evening administration
16070787|NCT02376790|Drug|Etanercept|Etanercept was administered by subcutaneous injection once a week
16070788|NCT02376790|Drug|Methotrexate|Methotrexate capsules taken orally once a week. Dosing was initiated at 10 mg weekly and titrated up to a final dose of 20 mg weekly over a 4-week period.
16070789|NCT02376790|Drug|Placebo to Etanercept|Placebo to etanercept was administered by subcutaneous injection once a week.
16070790|NCT02376790|Drug|Placebo to Methotrexate|Placebo to methotrexate capsules taken orally once a week.
16070791|NCT02376777|Other|Follow up|each three months during one year of follow up, general practioners will entered health data in database (hemorrhagic events, changes of medication, biological data...)
16070792|NCT02376764|Procedure|Blood drawing (venipuncture)|Patients with Deep Vein Thrombosis will undergo blood drawing in order to collect plasma samples.
16070793|NCT02376751|Drug|sebelipase alfa|
16070794|NCT02376725|Procedure|Phaco/IOL|Phaco/IOL refers to extracapsular cataract extraction (using phacoemulsification) and intraocular lens implantation
16070795|NCT02376725|Procedure|Phaco/IOL + goniosynechialysis|Phaco/IOL refers to extracapsular cataract ectraction (using phacoemulsification) and intraocular lens implantation. Goniosynechialysis refers to mechanical breaking of peripheral anterior synechiae using a spatula and goniolens to view the drainage angle structures.
16070796|NCT02376699|Drug|Intravenous (IV) SEA-CD40|Given intravenously; schedule is cohort-specific.
16070797|NCT02376699|Drug|Pembrolizumab|Given intravenously; schedule is cohort-specific.
16070798|NCT02376699|Drug|Subcutaneous (SC) SEA-CD40|Given subcutaneously on Day 1 every 3 weeks
16070799|NCT02376699|Drug|Gemcitabine|1000 mg/m^2 given intravenously on Day 1, 8, and 15 of each 28-day cycle
16070800|NCT02376699|Drug|Nab-paclitaxel|125 mg/m^2 given intravenously on Day 1, 8, and 15 of each 28-day cycle
16070801|NCT02376686|Other|Music intervention|Patient receives Music Intervention before going to sleep. It is composed Music which the Patient hear with maysound Music player.
16070802|NCT02376673|Other|Children's Book|A specially-designed, illustrated (full color) children's book written at a first-grade level, conveying American Academy of Pediatrics safe sleep guidelines through the story. Expanded guidelines are listed on the back cover, at a 4th grade reading level. This book will be exclusively used for safe sleep education at 3 study home visits: prenatal between 32 weeks and term, 1 week postnatal, and 2 months postnatal. The mother will be encouraged to share the book with her baby.
16070803|NCT02376673|Other|Standard Brochures|An assortment of standard safe sleep educational brochures provided by home visitors during prescribed home visits, covering various recommendations for safe sleep.
16070804|NCT02376660|Other|Oats|
16070805|NCT02376647|Other|Driving pressure limited ventilation|"Investigators will use volume controlled (or pressure support ventilation) and adjust tidal volume between 3 and 8 mL/Kg of predicted body weight in order to achieve a driving pressure of 13 cmH2O. The respiratory rate will be titrated to achieve a pH between 7.30 and 7.45 (maximum respiratory rate is 50 breathings per minute). Investigators will not limit plateau pressure in this arm.
~Once a daily the investigators will assess the target tidal volume that generates a driving pressure of 13cmH2O. The patient should be sedated and without spontaneous efforts during this assessment."
16070806|NCT02376647|Other|Conventional ventilation|Investigators will use volume controlled or pressure support ventilation, tidal volume ≤8 mL/kg of predicted body weight and plateau pressure limited to 30 cmH2O.The respiratory rate will be titrated to achieve a pH between 7.30 and 7.45 (maximum respiratory rate is 35 breathings per minute).
16070807|NCT02376634|Behavioral|Hypnosis|Patients will be taught self-hypnosis.
16070845|NCT02376400|Biological|Ad26.ZEBOV|One 0.5 mL IM injection of 5*10^10 viral particles (vp) on Day 1, 29 or 57.
16070846|NCT02376400|Biological|Placebo|One 0.5 mL IM injection of 0.9% saline on Day 1 and 29 or on Day 1 and 57.
16071150|NCT02374567|Drug|Paroxetine|
16071151|NCT02374567|Drug|Sertraline|
16070808|NCT02376621|Dietary Supplement|PronovaPure 150:500 triglycerides|Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period. The order of treatments will be in accordance with the randomisation schedule. Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
16070809|NCT02376621|Dietary Supplement|Pronovum PRF-048|Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period. The order of treatments will be in accordance with the randomisation schedule. Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
16070810|NCT02376621|Dietary Supplement|Pronovum PRF-037|Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period. The order of treatments will be in accordance with the randomisation schedule. Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
16070811|NCT02376621|Dietary Supplement|PronovaPure 500:200 TG|Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period. The order of treatments will be in accordance with the randomisation schedule. Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
16070812|NCT02376621|Dietary Supplement|Pronovum PRF-047|Subjects will receive 5 single doses with at least 4 treatment-free days between each treatment period. The order of treatments will be in accordance with the randomisation schedule. Using a Williams design, 2 subjects will be randomly assigned to receive 1 of the following 10 treatment sequences:ABECD,BCADE, CDBEA, DECAB, EADBC, DCEBA, EDACB, AEBDC, BACED, CBDAE
16070813|NCT02376608|Dietary Supplement|Pronova Pure 150:500 EE EU|Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period
16070814|NCT02376608|Dietary Supplement|Pronovum PRF-037|Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period
16070815|NCT02376608|Dietary Supplement|Pronovum PRF-041|Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period
16070816|NCT02376608|Dietary Supplement|Eskimo-3|Each subject will participate in 4 treatment periods. The subjects are randomized to one of the following treatment sequences ABCD, BDAC, CADB, DCBA. 4 treatment free days between each treatment period
16070817|NCT02376595|Drug|Rocuronium Bromide|Rocuronium 0,3 mg/kg in less than five seconds, followed by a saline bolus.
16070818|NCT02376582|Biological|DNA|DNA co-administered with protein at month 0, 1 and 6
16070819|NCT02376582|Biological|AIDSVAX B/E|Protein co-administered with DNA at month 0,1 and 6
16070820|NCT02376543|Device|19 Gauge EUS FNA BNX|There will be fiducials placed in the pancreas according to facility policy and procedure utilizing the 19 gauge needle.
16070821|NCT02376543|Device|22 Gauge EUS FNA BNX|There will be fiducials placed in the pancreas according to facility policy and procedure utilizing the 22 gauge needle.
16070822|NCT02376530|Behavioral|Nutrient profiling|Nutrient profiling system will be present during shopping session.
16070823|NCT02376530|Behavioral|Price Changes|Price changes will be present during shopping session.
16070824|NCT02376517|Behavioral|Educational program|The educational program consists of a short (13 pages) read-along book in English and Spanish. This book presents sun protective practices at an appropriate level for 2-6 year old children to read with their parent or caregiver. A sun protective swim shirt, which provides a sun-protection factor (SPF) of over 50, for the child will be provided. Additionally, the parent will receive weekly text message reminders to practice sun protection.
16070825|NCT02376504|Behavioral|Active workplace|This is a 12-month, cluster-randomized trial with an intent-to-treat design to determine the effects of using treadmill and sit-to-stand workstations at the workplace on health variables in overweight office workers (N=66) with seated desk jobs and (2) to compare the efficacies of treadmill and sit-to-stand workstations in decreasing workplace sedentary behavior. The intervention will examine the effects of using these workstations on weight, cardiovascular and metabolic health variables , musculoskeletal discomfort, psychological affect and job stress. The study will also measure change in time spent sitting, standing and walking will be measured using wearable non-invasive acceleration sensors.
16070826|NCT02376491|Device|Transcranial magnetic stimulation|
16070827|NCT02376478|Drug|TNF-alpha inhibitors|therapy for at least 6 months
16070828|NCT02376478|Drug|Alternative/no medication|therapy for at least 6 months or no therapy
16070829|NCT02376478|Other|Alternative/no medication|phototherapy for at least 6 months
16070830|NCT02376478|Drug|Purine/folic acid analogues|therapy for at least 6 months
16070831|NCT02376465|Drug|BLI4600 bowel preparation|Oral bowel preparation for colonoscopy
16070832|NCT02376465|Drug|PEG based bowel preparation|Oral bowel preparation for colonoscopy
16070833|NCT02376452|Drug|Raltitrexed|2mg/m2 iv gtt, d1
16070834|NCT02376452|Drug|Irinotecan|180 mg/m2 iv gtt, d1
16070835|NCT02376452|Drug|5-fluorouracil|5-FU 400mg/m2 iv, 2400mg/m2 civ 46h
16070836|NCT02376452|Drug|Leucovorin|400mg/m2 iv gtt,d1
16070837|NCT02376439|Other|Kool-aid|Participant drank two different types of kool-aid (sugar free and regular)
16070838|NCT02376426|Biological|MVA-BN-Filo|One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]) on Day 1, 29, 57.
16070839|NCT02376426|Biological|Ad26.ZEBOV|One 0.5 mL IM injection of 5*10^10 viral particles (vp) on Day 1, 29, 57.
16070840|NCT02376426|Biological|Placebo|One 0.5 mL IM injection of 0.9% saline on Day 1 and 29 or on Day 1 and 57.
16070841|NCT02376413|Procedure|Breast surgery|Traditional breast-conserving surgery, oncoplastic breast-conserving surgery or modified radical mastectomy
16070842|NCT02376413|Drug|Chemotherapy or endocrine therapy or Trastuzumab therapy|
16070843|NCT02376413|Radiation|Radiation therapy|
16070844|NCT02376400|Biological|MVA-BN-Filo|One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]) on Day 1, 29 or 57.
16070847|NCT02376374|Other|Controlling vaccination rates in communities|Three communities will be in three arms, one per arm. From 150 randomly-selected households, 10% will receive OPV in one community, 30% in the second community, and 70% in the third community.
16070848|NCT02376361|Device|Transonic|"Access recirculation, access flow would be determined using the ultrasound dilution technique (Transonic system).
~Within 90 min of the beginning of HD session HD03 sensors are clamped HD tubing lines
~Recirculation, access flow will be performed according to HD03 Manual.
~Post intervention evaluation is as per each arm follow up unless other follow up deemed necessary by the interventionalist."
16070849|NCT02376348|Behavioral|A targeted demand creation Activities|Sites randomized to the intervention arm will receive all activities in the control arm, plus additional demand-creation communication messages that focus on the non-HIV benefits of VMMC and the voluntary nature of HIV testing prior to VMMC ii) use of already circumcised men from the community as auxiliary peer promoters, iii) separate waiting and group education areas for men aged 20 years and above during service delivery, iv) engagement of female partners in community-based demand creation and education and counselling about wound healing and post-circumcision abstinence.
16070850|NCT02376335|Biological|Rituximab|The Rituximab dosing regimen identified is that used in the proof of concept study, which is also the established treatment regimen for Rituximab use in rheumatoid arthritis. All interventions will be administered with a clinician present throughout the infusion in participants who have been encouraged to have adequate oral hydration in the 24 hours prior to attendance. Resuscitation equipment will be immediately available during the infusion period. Blood pressure, heart rate and temperature will be monitored during the infusion. Participants will continue to be observed in the Clinical Research Facility for at least 1 hour after the infusion.
16070851|NCT02376335|Other|Placebo|Participants will be randomised to Rituximab therapy (1000 mg IV on day 1 and 15) or placebo (0.9% Sodium Chloride 250 mls) control
16070852|NCT02376322|Radiation|Radiotherapy|Hypofractionated radiotherapy regimen, 16 Gy in 2 fractions in complicated bone metastases in patients with poor performance status
16070853|NCT02376309|Behavioral|Inactivity|Inactivity
16070854|NCT02376309|Drug|ND|1 nandrolone decanoate injection
16070855|NCT02376309|Dietary Supplement|Leu|Leucine supplements
16070856|NCT02376296|Drug|docetaxel|3-weekly docetaxel therapy (starting dose of 75 mg/m2)
16070857|NCT02376296|Other|Blood draws|Blood draws for determination of docetaxel plasma levels and exposure (AUC)
16070858|NCT02376283|Drug|Prasugrel|
16070859|NCT02376283|Drug|Clopidogrel|
16070860|NCT02376283|Drug|ticagrelor|
16070861|NCT02376270|Dietary Supplement|Pectin|This group will receive 7.5 grams of pectin supplements twice daily for four weeks.
16070862|NCT02376270|Dietary Supplement|Maltodextrin|This group will receive 7.5 grams of maltodextrin supplements twice daily for four weeks.
16070863|NCT02376257|Drug|250 mg DCS|Drug
16070864|NCT02376257|Drug|100 mg Modafinil|Drug
16070865|NCT02376257|Drug|Placebo|Drug
16070866|NCT02376244|Other|High intensity interval training (HIIT)|Standard care cardiac rehabilitation classes, delivered at a higher exercise intensity
16070867|NCT02376244|Other|Standard care|Standard care cardiac rehabilitation according to current guidelines
16070868|NCT02376231|Device|Surgery for EOC with trial (PJ) device (PlasmaJet)|Debulking surgery for EOC using PJ device
16070869|NCT02376218|Drug|Hypertonic 50% dextrose pleurodesis|Intrapleural administration of 180ml of hypertonic dextrose solution.
16070870|NCT02376205|Drug|bupivacaine hydrochloride 0.5% solution|10mL will be poured into the retropharyngeal space intraoperatively during anterior cervical discectomy and fusion procedure
16070871|NCT02376205|Drug|0.9% NaCl solution|10mL will be poured into the retropharyngeal space intraoperatively during anterior cervical discectomy and fusion procedure
16070872|NCT02376192|Device|Initial MicroScan® (Microvision Medical) SDF Measurement|Initial SDF measurements are recorded in the obstetric preoperative area within two hours prior to administration of spinal anesthesia.
16070873|NCT02376192|Drug|Spinal Anesthesia- Bupivacaine|The spinal anesthetic technique is standardized. In the operating room spinal anesthesia will be administered with the L2-L5 interspaces in the sitting position using 12 mg of hyperbaric bupivacaine with 15 mcg of fentanyl and 150 mcg of preservative free morphine.
16070874|NCT02376192|Device|Comparative MicroScan® (Microvision Medical) SDF Measurement|A second comparative SDF measurement be recorded within 10 minutes after induction of spinal anesthesia.
16070875|NCT02376192|Drug|Bolus Phenylephrine/Ephedrine Treatment|Participants who experience hypotension following induction of spinal anesthesia will be treated with a bolus of phenylephrine and/or ephedrine as needed.
16070876|NCT02376192|Drug|Phenylephrine Infusion|Participants will have an infusion of phenylephrine started immediately following the induction of spinal anesthesia for prevention of hypotension.
16070877|NCT02376179|Device|Cuffed ETT|
16070878|NCT02376166|Drug|Metformin|850 mg PO twice daily for the remainder of the study period (the dose of metformin will be increased to the 850 mg PO twice daily dose in the absence of grade > 1 toxicities)
16070879|NCT02376153|Device|ABS deployed and active|ABS is deployed onto surgical field and is turned on.
16070880|NCT02376153|Device|ABS deployed and NOT active|ABS is deployed onto surgical field and is NOT turned on.
16070881|NCT02376127|Procedure|Dynamic contrast enhancement MRI|
16070882|NCT02376114|Drug|Ginkgo biloba|The Ginkgo biloba extract that was used contained 24% ginkgo flavone glycosides and 6% terpene lactones (Vitamin Research Products, Carson City, Nevada). Patients took 60 mg of Ginkgo or a placebo twice daily by mouth for two weeks. The placebo consisted of 40 mg of corn starch. Ginkgo and the placebo were encapsulated to ensure identical appearance.
16070883|NCT02376114|Drug|Placebo to Ginkgo biloba|
16070884|NCT02376101|Procedure|Surgery less than 60 minutes|
16070885|NCT02376088|Drug|Methimazole|All enrolled subjects with GD were treated with methimazole. The initial dose for the GA1 and GB1 sungroups were 30 mg/d (10 mg, tid), TH levels were tested every month, and the dose was titrated accordingly over a period of 2-3 months, the dose was then decreased to 15-20 mg/d and thyroid function was monitored periodically until it eventually reached the maintenance dose of 2.5 mg-5.0 mg/d. The dose and adjustment method for GA2 and GB2 were the same with GA1 and GB1, while the dose for GA3 and GB3 was gradually decreased to 2.5-5.0 mg/d. All subjects underwent a treatment course over a period of 6 months.
16070886|NCT02376075|Drug|Linagliptin|Intake of tablets containing 5 mg Linagliptin, administered once daily as add on to pre-existing antihypertensive treatment for 6 weeks
16070887|NCT02376075|Drug|Placebo|Intake of Placebo, administered once daily as add on to pre-existing antihypertensive treatment for 6 weeks
16070888|NCT02376062|Other|Bundled Intervention|"The authors have designed continuing medical education curriculum to improve clinical capacity and competency about mental health for Nepali Primary Care Providers. Specifically:
~On-site care coordinator and off-site psychiatric supervisors based in Nepal's capital, Kathmandu
~Weekly case conferences
~Surveys of clinicians and clinical supervisors in accordance with CME curriculum"
16070889|NCT02376049|Drug|Pimecrolimus cream|
16070890|NCT02376049|Drug|Betamethasone dipropionate cream|
16070891|NCT02376049|Drug|Clobetasol propionate cream|
16070892|NCT02376049|Drug|Glaxal Base cream vehicle|
16070893|NCT02376036|Drug|MGD010|MGD010 is a CD32B x CD79B bi-specific antibody-based molecular construct referred to as a Dual Affinity Re-Targeting (DART) molecule. MGD010 will be administered as a single agent.
16070894|NCT02376036|Drug|Placebo|Placebo comparator.
16070895|NCT02376036|Biological|Hepatitis A vaccine|Hepatitis A vaccine, inactivated
16070896|NCT02376023|Other|mHealth|Text and voice messages sent to study participants reminding them to schedule a PAP smear.
16070897|NCT02376010|Drug|rivaroxaban|
16070898|NCT02376010|Drug|Warfarin|
16070899|NCT02375997|Other|Palliative care|Early nutrition intervention and psychological intervention
16070900|NCT02375984|Biological|Tumor Infiltrating Lymphocytes (TIL)|Patients will receive an IV adoptive transfer of at least 10^9 tumor-reactive lymphocytes. An IV catheter in the patient's arm or upper chest will be used for cell infusion. The TIL will be administered over 20-30 minutes at room temperature using a standard infusion protocol or by hanging the infusion bag from a stand and allowing gravity to pull the cells down.
16070901|NCT02375971|Drug|Ranibizumab|Administered as an intravitreal injection
16070902|NCT02375971|Procedure|Laser therapy|Transpupillary diode or frequency-doubled yttrium aluminum garnet (YAG) laser ablative therapy, following anesthesia or sedation
16070903|NCT02375958|Drug|PCA062|
16070904|NCT02375945|Device|New non-elastic compression kit|Comparison of new non-elastic bandage kit with the currently accepted method
16070905|NCT02375945|Device|current compression stocking Comprinet®|Comparison of new non-elastic bandage kit with the currently accepted method
16070906|NCT02375932|Behavioral|Pre-Visit Tool|Patients receive a secure electronic message from their primary providers asking them to prepare for their visit by reviewing important areas of care and identifying their top priorities for discussion at a scheduled visit
16070907|NCT02375932|Behavioral|Usual Care Control|Patients continue to receive usual care from their primary care provider
16070908|NCT02375919|Other|PERC based Strategy|work up for diagnosis of PE includes calculation of PERC
16070909|NCT02375893|Other|No intervention|Collecting blood and feces samples
16070910|NCT02375893|Other|Healthy subject|Collecting blood and feces samples
16070911|NCT02375880|Drug|DKN-01|Administration by intravenous (IV) infusion.
16070912|NCT02375880|Drug|gemcitabine|Administered by IV infusion.
16070913|NCT02375880|Drug|cisplatin|Administered by IV infusion
16070914|NCT02375867|Drug|prednisolone|Oral administration of 1 mg/Kg/day
16070915|NCT02375867|Drug|methylprednisolone|Intravenous injection of 0.8 mg/kg/day
16070916|NCT02375854|Other|Observation|
16070917|NCT02375841|Behavioral|psychometric tests, questionnaires and neurocognitive assessments|
16070918|NCT02375828|Drug|Glibenclamide|Glibenclamide pills will be administrated during one month at the previously used dosage. During the first month of the study we wwil record pharmacokinetic data, number of hypoglycaemia and the administration problems associated to this galenic form. At the end of the first month of enrolment, patients will be given oral solution of glibenclamide for the 4 remaining months. Pharmacocinetic data, number of hypoglycaemia and parents and children feeling about pratictability of administration will be then recorded.
16070919|NCT02375815|Other|Statin Choice Implementation|
16070920|NCT02375802|Biological|Adipose-derived stromal cells|Adipose-derived stromal cells contain stem cells which have been successful in enhancing wound healing. The product used as the carrier is a fibrin sealant called TISSEEL. Pre-pilot testing was done to verify viability of the stromal cells for up to 72 hours in the fibrin sealant.
16070921|NCT02375802|Drug|Adipose-derived stromal cells|
16070922|NCT02375789|Device|Active RhinoChill|"The device is intended for use for the reduction of temperature via the nasal cavity.
~The RhinoChill® System is a British Standards Institution Kite-Marked device that is currently commercially available in Europe. The RhinoChill® device is intended for temperature reduction in patients via the nasal cavity."
16070923|NCT02375789|Device|Placebo RhinoChill|The placebo RhinoChill device looks and functions in an identical way to the active RhinoChill. All components are used, however through some minor changes in the design of the device it now provides a sufficient placebo treatment to the patient.
16070924|NCT02375776|Other|"CORA- Device:smartphones"|Participants will download and use Multi - modal mobile smartphone application (CORA -Device:smarthpones) designed for renal cell and prostate cancer patients taking anti-cancer medications
16070925|NCT02375763|Other|Software instruction|
16070926|NCT02375750|Device|GBO and GBG|Application of GBO and GBG to the defect fill after removal of chronic inflammatory tissue and decontamination of the surface of implant
16070927|NCT02375750|Other|Standard treatment|Removal of chronic inflammatory tissue using titanium curettes and a rotary titanium brush; Implant Surface decontamination and closure by suturing
16070928|NCT02375737|Behavioral|m-health|Patients will receive e-reminders via text message and email. A message library that allows us to disseminate constant and reliable information has been created. Messages will contain not only medication reminders, but information about issues related to self-management and medication adherence for CVD risk including messages on side-effects, risks/benefits of medication treatment, and barriers to medication adherence. In addition to these messages, patients will also receive tailored information via telephone by trained research staff.
16070929|NCT02375724|Drug|Aclidinium Bromide|Inhaled Aclidinium 400 μg twice per day by Eklira Genuair Inhaler
16071045|NCT02374853|Drug|Vancomycin|Topical prophylactic antibiotic
16070930|NCT02375724|Drug|Placebo|Inhaled dose-matched placebo, twice per day by Eklira Genuair Inhaler
16070931|NCT02375711|Biological|Blood sample|A blood sample of 35 ml is achieved at 1 month to evaluate the anti-HBV cell response. Two other blood samples of 10 ml are scheduled 3 and 6 months after vaccination to assess humoral response to HBV vaccination.
16070932|NCT02375698|Biological|H56:IC31|H56:IC31 contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c).
16070933|NCT02375698|Biological|Placebo|The placebo consists of 10mM Tris and 169 mM NaCl pH 7.4.
16070934|NCT02375685|Biological|Gevokizumab|
16070935|NCT02375672|Drug|Pembrolizumab|Pembrolizumab (MK-3475) 200mg IV over 30 minutes every 3 weeks
16070936|NCT02375672|Drug|mFOLFOX6|"mFOLFOX6 Treatment D1 and D15 (Cycle = 28 days)
~Oxaliplatin 85 mg/m^2 IV with
~Leucovorin 400 mg/m^2 IV followed by
~5FU 400 mg/m^2 bolus and then 2400 mg/m^2 via continuous infusion"
16070937|NCT02375646|Drug|Warfarin|
16070938|NCT02375646|Drug|LMW Heparin|
16070939|NCT02375633|Drug|DW-330SR2|
16070940|NCT02375633|Drug|Pelubiprofen|
16070941|NCT02375620|Biological|PEG-somatropin|
16070942|NCT02375607|Device|Algometer|Algometer performed patients
16070943|NCT02375594|Other|Exercise in park equipment|
16070944|NCT02375581|Drug|Icotinib|125mg, Po, TID during RT
16070945|NCT02375581|Radiation|Thoracic radiotherapy|involved-Field irradiaton without elective nodal irradiation
16070946|NCT02375568|Other|103024-F|mesenchymal stem cell isolation
16070947|NCT02375555|Drug|Lenalidomide|
16070948|NCT02375555|Drug|Elotuzumab|
16070949|NCT02375555|Drug|Bortezomib|
16070950|NCT02375555|Drug|Dexamethasone|
16070951|NCT02375555|Procedure|Stem Cell Mobilization|
16070952|NCT02375529|Procedure|Single Incision Laparoscopic Cholecystectomy (SILC)|A 2.5-cm incision is made through the everted umbilicus down to the midline fascia, and through the fascia and the peritoneum. The multichannel port (Olympus) is introduced. Carbon dioxide is insufflated (12 mmHg) and a 30 degree 10-mm laparoscope is introduced. The operating table is put in the reverse Trendelenburg position (20 degrees), left side down. A pre-curved grasper and the monopolar electrocautery are introduced through the other 2 ports of the trocar and the dissection of the gallbladder starts in a retrograde manner. The triangle of Calot is exposed, the cystic duct and artery are separately dissected and ligated with 5 mm clips. The monopolar electrocautery is used to remove the gallbladder from the liver bed. The gallbladder is removed along with the port system from the abdominal cavity. The fascia at the port site is closed and the umbilicus is inverted.
16070953|NCT02375529|Procedure|Four Ports Laparoscopic Cholecystectomy (4PLC)|"An 11-mm periumbilical port, a 10-mm left upper quadrant port , 5mm subxyphoid port, and 5-mm right lower quadrant port were used in 4-port LC. We adopted the single surgeon technique in the 4-port LC using 30-degree operating telescopes that was inserted into the umbilical port. Retraction of the gallbladder was done by the long grasping forceps through the 5-mm right lower quadrant port, whereas dissection was accomplished through the 10-mm left upper quadrant port. The cystic duct and cystic artery were clipped by a 5-mm multiple clip applicator. The gallbladder was retrieved through the umbilical port after the position of the operating telescope was changed.
~Nontransparent surgical adhesive tape was applied to the standard 4-port sites at the end of the operation ."
16070954|NCT02375516|Behavioral|Prevention Program|Youths in the intervention-arm will interact online with the initial intervention program between pretest and posttest measurement occasions and will interact with booster sessions subsequent to 1- and 2-year follow-up measurement occasions. Owing to the expense associated with developing a treatment-as-usual intervention for computer delivery in the control arm, youths assigned to the control arm will receive no intervention.
16070955|NCT02375503|Dietary Supplement|Calcium/Vitamin D|Daily, calcium and vitamin D fortified snack bar
16070956|NCT02375503|Dietary Supplement|Placebo|
16070957|NCT02375490|Behavioral|Healthy Start|Healthy Start was designed to promote physical activity and healthy eating among 3-5 year old children. Specifically, Healthy Start attempts to influence factors at the intrapersonal, interpersonal, organizational, community and physical environment and political levels. These levels of influence are targeted such that from an operational stand point, Healthy Start is composed of six interlinked components: 1) intersectoral partnerships that leads to promoting healthy weights in communities and ECC; 2) The Healthy Start guide for educators; 3) customized training, role modelling and monitoring; 4) an evidence-based resource for both families and educators; 5) supplementary resources from governmental partners; and 6) a knowledge development and exchange, and communication strategy.
16070958|NCT02375477|Other|Educational Intervention|Given educational presentation
16070959|NCT02375464|Drug|Gallium-68 DOTATOC|Imaging with Gallium-68 DOTATOC
16070960|NCT02375451|Other|Radioiodine|We will determine if prior radioiodine treatment in childhood impacts salivary function or symptoms. Radioiodine treatment will have been determined by the patient's medical condition and care (NOT assigned by this research study).
16070961|NCT02375425|Other|no intervention|no intervention-specimen collection study only
16070962|NCT02375412|Procedure|Pre-operative measurement of heart rate variability|Pre-operative measurement of heart rate variability in patients undergoing elective major abdominal surgery
16070963|NCT02375386|Procedure|Spinal manipulation|Participants will receive a lumbar SMT technique previously described in the literature and commonly utilized for the treatment of low back pain . The SMT will be performed four times (two times on each side) in a 5-minute period. In addition, the following will be performed: Functional MRI, Behavioral: Pain Sensitivity Testing, Questionnaires,Behavioral: Physical Impairment.
16070964|NCT02375386|Procedure|Therapeutic touch|"Participants in this group will lie prone. The therapist will place both hands in contact with the participants' pelvis across the top of the posterior aspect of the sacrum and ilia and apply a downward force to keep the pelvis in contact with the table. This group accounts for effects of time and personal contact. The amount of hands-on contact will be equivalent between groups. Both groups will be given the same verbal instructions regarding the techniques performed. In addition, the following will be performed: Functional MRI, Behavioral: Pain Sensitivity Testing, Questionnaires,Behavioral: Physical Impairment."
16070965|NCT02375386|Procedure|fMRI|Both groups will receive an fMRI.
16070966|NCT02375386|Behavioral|Pain Sensitivity Testing|Both groups will receive an Pain Sensitivity Testing
16070967|NCT02375386|Other|Questionnaires|Both groups will receive Questionnaires
16070968|NCT02375386|Behavioral|Physical Impairment|Both groups will receive testing on physical impairment.
16070969|NCT02375373|Other|Observational Chickpea Diet|"Individuals encouraged to maintain increased legume intake and explore new recipes that allow them to maintain a diverse menu of legume based foods.
~Fecal samples collected monthly."
16070970|NCT02375360|Other|Oral immunotherapy|
16070971|NCT02375347|Other|Chickpea Enhanced Diet (Short term)|"Dry Roasted Chickpeas, 21.26 gram serving size bags, by mouth five times per week.
~Stool Samples collected at Day 1, Day 9, and Day 14."
16070972|NCT02375334|Other|Medical Chart Review|Medical chart review by the Cancer Center ORIS and EPIC based systems
16070973|NCT02375321|Behavioral|CPAP and Psychological support|Six sessions of psychological support with cognitive behavioural orientation lasting 1 hour every two weeks for 3 months
16070974|NCT02375308|Behavioral|HDT|20 sessions, individual psychotherapy
16070975|NCT02375308|Behavioral|ACDT|20 sessions, individual psychotherapy
16070976|NCT02375295|Drug|ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin|Approved antibiotics used routinely will be given at the physician's discretion with the patient: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin
16070977|NCT02375282|Procedure|Ambulation orderly|The responsibility of the ambulation orderly is to walk patients after having a cardiac surgery, such as a coronary artery bypass surgery or a valve surgery. Baystate Medical Center hired an ambulation orderly May 8, 2013. The ambulation orderly is generally a high school graduate with some training in safe lifting and exercise, but extensive training is not required. In general, the goal is to have 1 ambulation orderly present 7 days a week for 8 hr per day. When available, ambulation orderlies are responsible for walking the patients who have been cleared by the clinical exercise physiologist or nurse up to 4 times per day. The walking of the patients occurs through the halls of the 6th floor of the Mass Mutual wing of Baystate Medical Center.
16070978|NCT02375269|Device|RIPC with a tourniquet|
16070979|NCT02375256|Biological|AERAS-402|Live recombinant serotype 35 replication deficient adenovirus vector expressing a fusion protein of 3 Mycobacterium tuberculosis antigens (Ag85A, Ag85B, and TB10.4).
16070980|NCT02375256|Biological|Placebo|Identical buffer solution in which AERAS-402 is formulated.
16070981|NCT02375256|Biological|BCG (1-8 x105 cfu ID)|BCG given to all participants at day -84 prior to a boost with either Aeras-402 or placebo.
16070982|NCT02375243|Drug|dexmedetomidine|dexmedetomidine continous infusion 0.5 mcg/kg/h
16070983|NCT02375230|Procedure|Control group|Health care provider randomized to the control group will receive a copy of the NRP text pages discussing MR SOPA at every shift for self-study. They will be encouraged by the educator to study these pages for five minutes at every shift. The educator will be there to answer questions if they arise.
16070984|NCT02375230|Procedure|MR SOPA|"Health care provider randomized to the MR SOPA group will receive MR SOPA training provided by a qualified educator on every shift. This training will be five minutes long and will consist of each MR SOPA step. These corrective steps will be demonstrated and practiced on a low-fidelity neonatal mannequin. The alternative airway practice will be performed on an intubation mannequin in the DR also placed on the DR resuscitation unit. Each participant will receive five minutes of training at the start of each shift."
16070985|NCT02375217|Drug|Sugammadex|half dose
16070986|NCT02375217|Drug|Sugammadex|full dose
16070987|NCT02375217|Drug|Neostigmine|IV = 50mcg/kg
16070988|NCT02375217|Drug|glycopyrrolate|
16070989|NCT02375204|Drug|paclitaxel|IV
16070990|NCT02375204|Drug|ifosfamide|IV
16070991|NCT02375204|Drug|cisplatin|IV
16070992|NCT02375204|Drug|pegylated G-CSF|IV
16070993|NCT02375204|Drug|G-CSF|IV
16070994|NCT02375204|Drug|carboplatin|IV
16070995|NCT02375204|Drug|etoposide phosphate|IV
16070996|NCT02375204|Procedure|stem cell reinfusion|surgical procedure
16070997|NCT02375191|Drug|fentanyl|
16070998|NCT02375191|Drug|dexmedetomidine|
16070999|NCT02375191|Drug|Ropivacaine|
16071000|NCT02375178|Drug|chlorhexidine|The volunteers will be instructed to mouthwash with 10ml of a sterile saline solution for 30 seconds and than make the mouthwash with 10ml of an 0.12% chlorhexidine solution. Samples of saliva will be collected immediately before the mouth wash and after 30, 60 and 180 minutes.
16071001|NCT02375178|Drug|Polyhexamethylene biguanide|The volunteers will be instructed to mouthwash with 10ml of a sterile saline solution for 30 seconds and than make the mouthwash with 10ml of an 0,07% solution Polyhexamethylene biguanide. Samples of saliva will be collected before the mouth wash and after 30, 60 and 180 minutes.
16071002|NCT02375178|Drug|Sterile saline solution|The volunteers will be instructed to mouthwash with 10ml of a sterile saline solution for 30 seconds and than make the mouthwash with 10ml of a sterile saline solution. Samples of saliva will be collected before the mouth wash and after 30, 60 and 180 minutes.
16071003|NCT02375165|Procedure|phlebotomy|phlebotomy for collection of plasma and serum, ~30 cc
16071004|NCT02375152|Procedure|Anterior Capsulotomy|
16071005|NCT02375139|Drug|DA-1229_01|complex single administration
16071006|NCT02375139|Drug|E+M|co-administration of 2 drugs
16071007|NCT02375126|Procedure|Electroencephalography|Electroencephalography (EEG) is a relatively inexpensive measurement of basic brain activity. Traditional EEG techniques rely on the clinician to visually examine the electrical current waveforms to identify abnormal signal patterns and slowing. Abnormalities on EEG have been reported following CO poisoning, though the literature is scarce. While current EEG technologies record EEG signals digitally, rather than writing directly to paper, computer-assisted analysis of the data (quantitative EEG, or qEEG) has not been widely embraced, in part because clinicians are unsure what patterns revealed by computer-assisted analysis represent abnormal activity.
16071046|NCT02374853|Other|No Vancomycin|Placebo: Sterile water. No Vancomycin.
16071047|NCT02374827|Procedure|Standard postpartum tubal ligation|Patients will undergo a standard postpartum tubal ligation by accepted documented surgical procedural methods (Modified Pomeroy or Parkland method)
16071048|NCT02374827|Procedure|Complete Salpingectomy|Patients will undergo a complete salpingectomy by a documented surgical protocol established by accepted surgical procedural methods.
16071049|NCT02374814|Drug|Rabies vaccine|Compare dose schedule and route of administration
16071050|NCT02374814|Drug|Placebo|Placebo
16071008|NCT02375113|Dietary Supplement|soy supplementation|"Isoflavones will be in the form of capsule (80 mg /capsule). Placebo capsule will be filled with cellulose. These capsules will be identical in size and color. Soy protein will be prepared in the form of powder, containing 25 g of soy protein per package. Placebo powder will contain 25 g whole milk protein. Both powders will be available in vanilla and chocolate flavors, and look and taste similar. They could be mixed with water, milk and other beverages. Subjects will be asked to consume 2 capsules and 1 powder packet daily, preferably at breakfast for 6 months.
~Subjects failing to show up at the monthly visit for refilling supplement will be contacted by research staff via email or phone."
16071009|NCT02375100|Procedure|Spinal Anesthesia|All patients will be administered 3ml of %0.5 bupivacaine through L3-L4 interspace to acquire motor and sensory blockade
16071010|NCT02375100|Procedure|Transversus Abdominis Plane Block|Analgesic intervention which will be performed only to Transversus Abdominis Plane Block arm. It requires 20ml of %0.25 bupivacaine administration through a 22 G. x 4 in. (100 mm) Insulated Echogenic Needle with 30° Bevel from midaxillary line between costal margin and anterior superior iliac spine with ultrasound guidance
16071011|NCT02375100|Procedure|Ilioinguinal Nerve Block|Analgesic intervention which will be performed only to Ilioinguinal Nerve Block arm. It requires 10ml of %0.25 bupivacaine administration through a 22 G. x 3-1/8 in. (80 mm) Insulated Echogenic Needle with 30° Bevel between umbilicus and iliac crest where the nerve is detected with ultrasound guidance
16071012|NCT02375100|Drug|Bupivacaine %0.5 (hyperbaric)|
16071013|NCT02375100|Drug|Bupivacaine %0.25 (isobaric)|
16071014|NCT02375100|Device|25G Quincke needle|
16071015|NCT02375100|Device|Echogenic Needle with 30° bevel|
16071016|NCT02375100|Drug|Acetaminophen|Analgesic drug administration through iv and im route postoperatively. Patients are administered iv acetaminophen 1g twice a day routinely
16071017|NCT02375100|Drug|Tramadol|Patients will be administered tramadol in postoperative period when their pain score exceeds 4 points (moderate pain)
16071018|NCT02375074|Behavioral|Supported Employment|Supported Employment (SE), focusing on competitive employment in real-life settings without long-lasting preceding training.
16071019|NCT02375074|Behavioral|Traditional Vocational Rehabilitation|Traditional Vocational Rehabilitation (TVR), offering training and preparation for the labor market in a sheltered environment
16071020|NCT02375061|Behavioral|e-BPS|
16071021|NCT02375061|Behavioral|Daily Activities|
16071022|NCT02375048|Radiation|Hypofractionated WBI|Dose prescription was 40.5 Gy to PTVWB and 48.0 Gy to PTVboost in 15 fractions over 3 weeks, with simultaneous integrated boost delivering 2.7 and 3.2Gy/fraction for each PTV respectively. Daily image guided radiotherapy (IGRT) were generated before each treatment session in each patient to verify the set-up.
16071023|NCT02375048|Radiation|Accelerated Partial Breast Irradiation|APBI was delivered at a dose of 30 Gy in five 6-Gy/day fractions over 10 days (every other day) with IGRT at each treatment.
16071024|NCT02375035|Device|CAMPROBE|To assess patient's experience and complications of the CAMPROBE biopsy needle and compare the results with known published outcomes from standard transrectal biopsies
16071025|NCT02375022|Drug|Endostar and icotinib|Endostar and icotinib are used as combination therapy.
16071026|NCT02375009|Procedure|Selective laser trabeculoplasty|laser therapy to trabecular outflow pathway of the eye to lower intraocular pressure, delivered to 360 degrees of both eyes in a single session
16071027|NCT02374983|Other|Gamma knife radiosurgery re-planning with convolution algorithm|"The convolution algorithm, which uses the correlation between CT imaging density in Hounsfield units (HU) and electron density (ρe) of the tissues as input to predict dose distribution, can provide a better simulation of real delivered dose for GKR. By more accurately predicting the dose delivered, a better prediction of clinical effects can be made, increasing the potential clinical efficacy of treatment.
~Convolution algorithm is now available in Leksell GammaPlan® 10 but there is not enough clinical data to support its use over TMR 10, which is the current clinical standard. Using convolution algorithm to recalculate the dose for the otherwise unaltered TMR 10 plan will provide valuable insight and understanding of the dosimetric differences between these planning algorithms."
16071028|NCT02374970|Other|Lumbar stability exercises|Four individualized learning sessions will be held during the same period of protocolized physiotherapy. Biofeedback training using the ultrasound machine will be performed in the first session, in order to show the specific contraction of the abdominal muscles with the stability exercises. The other three learning sessions will be performed without feedback, for the patient learn the exercises to make at home during the follow-up period.
16071029|NCT02374970|Other|Protocolized Physiotherapy|Therapeutic exercises and thermotherapy during 12 daily sessions
16071030|NCT02374957|Drug|Cilostazol|100 mg twice daily for 90 days
16071031|NCT02374944|Procedure|Hardware removal|
16071032|NCT02374931|Drug|F-18 16 Alpha-Fluoroestradiol|Undergo 18F-FES PET/CT
16071033|NCT02374931|Procedure|Positron Emission Tomography|Undergo 18F-FES PET/CT
16071034|NCT02374931|Procedure|Computed Tomography|Undergo 18F-FES PET/CT
16071035|NCT02374931|Other|Laboratory Biomarker Analysis|Correlative studies
16071036|NCT02374918|Device|mTBI wavelength-1 bright light|6 weeks of daily light exposure, 30 minutes per morning
16071037|NCT02374918|Device|mTBI wavelength-2 bright light|6 weeks of daily light exposure, 30 minutes per morning
16071038|NCT02374918|Device|HC wavelength-1 bright light|30 minutes of light exposure
16071039|NCT02374918|Device|HC wavelength-2 bright light|30 minutes of light exposure
16071040|NCT02374905|Device|Drinksmeter|Web-based application delivering Identification and Brief Advice of Alcohol Use
16071041|NCT02374905|Behavioral|Brief Advice of Alcohol Use|Lifestyle counseling regarding alcohol intake and completion of Audit-10 questionnaire done chair-side with clinician
16071042|NCT02374892|Behavioral|CHAPTER III Study Intervention|This will involve a 60 minute interaction between the adolescent and a cardiology nurse. A MyHealth passport will be created covering the name of the adolescents' cardiac condition, previous cardiac interventions, and name and purpose of the teen's medications. Potential late cardiac complications will be discussed. The adolescent and nurse will watch videos on talking to various health professionals. The adolescent will be given a study email address and encouraged to contact the nurse by email or text messaging with follow-up
16071043|NCT02374879|Device|Blood Glucose Monitoring Systems.|In vitro diagnostic medical device.
16071044|NCT02374866|Other|closer monitoring|
16071051|NCT02374801|Device|"SonR automatic optimization feature turned ON (AV+VV)."|
16071052|NCT02374788|Behavioral|Pedometer intervention|Intensive intervention with pedometer. The participants are instructed to set daily step goal and to record their daily steps on a website.
16071053|NCT02374788|Behavioral|Group meetings|Participants receive 12 group meetings over two years' time.
16071054|NCT02374788|Behavioral|Individual consultations|Participants receive 10 individual meetings with a diabetes specialist nurse. Physical activity on prescription is used to set individual goals and to highlight the importance of physical activity.
16071055|NCT02374749|Behavioral|self-assessment/self-management|Nurse led-program of self-assessment/ self-management of spondyloarthritis
16071056|NCT02374749|Behavioral|Comorbidities (detection/prevention)|Standardized assessment of comorbidities by nurses
16071057|NCT02374736|Drug|Privigen (Human normal immunoglobulin G (IgG > 98 % purity))|"Privigen (CSL Behring AG, Bern, Switzerland) 10% liquid human IgG for intravenous administration, 2 g/kg, given as 2 g/kg for 2 days/month for 6 months (maximum dose: 80 g/day).
~Privigen will be provided in vials containing 10 g IgG in 100 mL."
16071058|NCT02374723|Device|NuCornea|Deep anterior lamellar corneal transplantation where the NuCornea is substituting a donor cornea
16071059|NCT02374723|Device|donated human corneas|Deep anterior lamellar corneal transplantation with a donated cornea as graft material.
16071060|NCT02374710|Procedure|ACL Reconstruction: Anterior Tunnel|ACL reconstruction with anterior tibial tunnel placement in reference to a point measuring 35% of the anterior-posterior distance of the proximal tibia.
16071061|NCT02374710|Procedure|ACL Reconstruction: Posterior Tunnel|ACL reconstruction with posterior tibial tunnel placement in reference to a point measuring 35% of the anterior-posterior distance of the proximal tibia.
16071062|NCT02374697|Device|During tele-expertise|
16071063|NCT02374684|Drug|Methosulide|"Tolerability Study:
~Period I:Single oral administration,dose-escalation of Methosulide(six dose groups:25mg-250mg) Period II:Repeated oral administration of Methosulide(group 1:MTD（maximum tolerated dose）/250mg ,group 2:depending on the adverse drug reaction,150mg/250mg)
~Pharmacokinetic Study:
~Period I:Single oral administration,dose-escalation of Methosulide(three dose groups:50mg,100mg,200mg/250mg) Period II:Repeated oral administration of Methosulide(group 1:MTD（maximum tolerated dose）/250mg
~,group 2:depending on the adverse drug reaction,150mg/250mg)
~Food Effect on the Pharmacokinetics:
~single dose(100mg),two status(Feeding and fasting), washout period(7 days)"
16071064|NCT02374684|Drug|Placebo|Placebo to match with experimental groups
16071065|NCT02374671|Device|VisAbility Micro Insert|Subjects are implanted with the VisAbility Micro Insert (Model SGP-046) and followed for 24 months.
16071066|NCT02374658|Behavioral|Living Through the Arts Intervetion|A weekly one-hour creative arts program that will engage participants in several different creative processes, including visual art, music, dance, drama, and creative writing.
16071067|NCT02374645|Drug|Volitinib|600mg or 800mg QD: Patients may continue to receive the treatment as long as they are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
16071068|NCT02374645|Drug|gefitinib|250mg QD: Patients may continue to receive the treatment as long as they are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
16071069|NCT02374632|Other|Meal tests after saline injection|Fixed breakfast meal and ad libitum lunch meal
16071070|NCT02374632|Other|Meal tests after octreotide injection|Fixed breakfast meal and ad libitum lunch meal
16071071|NCT02374632|Other|Sham feeding|
16071072|NCT02374619|Dietary Supplement|Iron supplement Resoferon Ferrous Sulfate|Oral supplementation with one tablet of iron supplement [Resoferon Ferrous Sulfate 125 (37) mg]
16071073|NCT02374619|Dietary Supplement|Placebo|
16071074|NCT02374593|Drug|Levothyroxine|Levothyroxine dose will be adjusted at the first clinic visit based on thyroid anatomy on ultrasound.
16071075|NCT02374593|Device|Ultrasound|
16071076|NCT02374567|Drug|Phenobarbital|
16071077|NCT02374567|Drug|Phenytoin|
16071078|NCT02374567|Drug|Carbamazepine|
16071079|NCT02374567|Drug|Oxcarbazepine|
16071080|NCT02374567|Drug|Valproic Acid|
16071081|NCT02374567|Drug|Lamotrigine|
16071082|NCT02374567|Drug|Topiramate|
16071083|NCT02374567|Drug|Gabapentin|
16071084|NCT02374567|Drug|Levetiracetam|
16071085|NCT02374567|Drug|Pregabalin|
16071086|NCT02374567|Drug|Lacosamide|
16071087|NCT02374567|Drug|Clonazepam|
16071088|NCT02374567|Drug|Biperiden|
16071089|NCT02374567|Drug|Levomepromazine|
16071090|NCT02374567|Drug|Fluphenazine|
16071091|NCT02374567|Drug|Perphenazine|
16071092|NCT02374567|Drug|Perazine|
16071093|NCT02374567|Drug|Thioridazine|
16071094|NCT02374567|Drug|Haloperidol|
16071095|NCT02374567|Drug|Melperone|
16071096|NCT02374567|Drug|Pipamperone|
16071097|NCT02374567|Drug|Bromperidol|
16071098|NCT02374567|Drug|Benperidol|
16071099|NCT02374567|Drug|Sertindole|
16071100|NCT02374567|Drug|Ziprasidone|
16071101|NCT02374567|Drug|Flupentixol|
16071102|NCT02374567|Drug|Chlorprothixene|
16071103|NCT02374567|Drug|Zuclopenthixol|
16071104|NCT02374567|Drug|Fluspirilene|
16071105|NCT02374567|Drug|Pimozide|
16071106|NCT02374567|Drug|Clozapine|
16071107|NCT02374567|Drug|Olanzapine|
16071108|NCT02374567|Drug|Quetiapine|
16071109|NCT02374567|Drug|Sulpiride|
16071110|NCT02374567|Drug|Tiapride|
16071111|NCT02374567|Drug|Amisulpride|
16071112|NCT02374567|Drug|Prothipendyl|
16071113|NCT02374567|Drug|Risperidone|
16071114|NCT02374567|Drug|Aripiprazole|
16071115|NCT02374567|Drug|Paliperidone|
16071116|NCT02374567|Drug|Diazepam|
16071117|NCT02374567|Drug|Oxazepam|
16071118|NCT02374567|Drug|Lorazepam|
16071119|NCT02374567|Drug|Bromazepam|
16071120|NCT02374567|Drug|Clobazam|
16071121|NCT02374567|Drug|Alprazolam|
16071122|NCT02374567|Drug|Hydroxyzine|
16071123|NCT02374567|Drug|Buspirone|
16071173|NCT02374554|Device|Structured Light Plethysmography (Thora-3Di)|Respiratory Rate measured by Structured Light Plethysmography Thora-3Di and Clinician Over-scored End Tidal C02 (COSC) during 1 randomised minute of a 5 minute measurement period
16071174|NCT02374554|Device|BCI Capnograph 9004 (Smiths Medical)|Respiratory Rate measured by Structured Light Plethysmography Thora-3Di and Clinician Over-scored End Tidal C02 (COSC) during 1 randomised minute of a 5 minute measurement period
16071175|NCT02374541|Behavioral|Patient Navigation|The Autism Patient Navigator (APN) will interview families to determine system and individual barriers facing the family at each stage of the care process. The APN will help families to overcome any identified barriers through education, coaching, social support, interpretation or translation, linkage to resources (e.g., for obtaining insurance) or logistical support (e.g., scheduling appointments, providing reminders, arranging transportation), in order to ensure timely diagnostic evaluation / eligibility determination; educate the family about autism, tests and treatments; and offer psychosocial support.
16071176|NCT02374528|Procedure|Negative pressure wound therapy|Negative pressure wound therapy (NPWT) is the application of suction (negative pressure) to wounds with skin grafting.
16071177|NCT02374528|Procedure|standard pressure bolster dressing|This method is traditional used in skin grafting wound.
16071178|NCT02374515|Device|EndoCuff-assisted colonoscopy|Adenoma detection rate
16071179|NCT02374515|Device|Standard Colonoscopy|
16071180|NCT02374502|Behavioral|Brief Intervention|'Brief Intervention' is the term used to mean verbal advice, discussion, negotiation or encouragement, with or without written or other support or follow-up. 'Brief Interventions' provide a structured way to deliver advice and involve the provision of formal help and follow-up. They aim to equip people with tools to change attitudes and handle underlying problems.
16071181|NCT02374489|Drug|LDK378|LDK378 750 mg ( p.o.) daily, with 3 week as a treatment cycle.
16071182|NCT02374476|Device|Bipolar Ablation|Patients will undergo bipolar ablation if unipolar ablation unsuccessful
16071183|NCT02374463|Behavioral|MMBI|Multimodality Balance Intervention (MMBI): Our MMBI will be held 3-times a week for an hour and will consist of a group dynamic balance class (30 minutes), a supervised obstacle course (10 minutes), and lower extremity and core strengthening (20 minutes). The group exercise classes will focus on dynamic weight shifts with an emphasis on the lateral and diagonal directions. Over the 6 months of class, the exercises will gradually increase in difficulty to challenge balance. A skilled instructor will lead each class and 1-2 assistants will be present to assist with fall risk prevention. The supervised obstacle course will focus on obstacle negotiation, gait over challenging surfaces, and moving in lateral, diagonal, and backward directions. Finally, strength training of the lower extremities and core will focus on strengthening major muscles of the lower extremity and core utilizing commonly available gym equipment, ankle weights and body weight.
16071184|NCT02374463|Behavioral|Tai Chi|Tai Chi Intervention: The supervised Tai Chi class will be held 3-times a week for one hour. All Tai Chi classes will be taught in a group setting by an experienced instructor. The emphasis during the class will be on standing movements, body alignment, weight shift and changes of direction. Movements will be adapted as the class progresses to increase the difficulty of weight shift and change in direction over time so that participants balance is continually challenged throughout the 6 months. Chairs or hand rails will be available for the participants to use as needed for balance recovery.
16071186|NCT02374437|Drug|Aramchol|PART A: Subjects will receive single dose of 200 or 400 mg Aramchol PART B: Subjects will receive single dose of 600 mg Aramchol under fasting or fed conditions ( following a crossover between the groups) PART C: subjects will be equally randomized to receive either 200 mg, 400 mg, 600 mg or placebo tablets for ten consecutive days.
16071187|NCT02374437|Drug|Placebo|PART C: subjects will be equally randomized to receive either 200 mg, 400 mg, 600 mg or placebo tablets for ten consecutive days.
16071188|NCT02374424|Drug|GA101_DHAP|"Aim of the study is to assess whether the addition of GA101 to DHAP is more promising than standard R-DHAP, as induction therapy before high dose chemotherapy BEAM with ASCT with respect to response.
~Scheme of treatment:
~GA101 1000 mg iv day 1, 8, 15 on first cycle (starting from cycle 2, GA101 1000 mg day 1)
~Cisplatin 100 mg/sqm iv day 1 of every cycles in 24-hours infusion
~Cytarabine 2000 mg/sqm in 3-hours infusion every 12 hours iv day 2 of every cycles
~Dexamethasone 40 mg day 1-4 of every cycles
~Pegfilgrastim 6 mg sc single dose 24 hours after the end of chemotherapy or G-CSF from day 4 till stem cell harvest during mobilization's course (II o III cycle GA101-DHAP)
~GA101 1000 mg iv 24 hours before apheresis as purging in vivo during second courses of therapy"
16071189|NCT02374398|Drug|Tranexamic Acid|see arm/group descriptions
16071190|NCT02374398|Device|Aquamantys System|see arm/group descriptions
16071191|NCT02374398|Other|Control|Standard Electro-cautery and Saline
16071192|NCT02374385|Biological|BPSC-1001 (VSVΔG-ZEBOV)|Ebola vaccine candidate
16071193|NCT02374385|Other|Placebo|Normal saline
16071194|NCT02374372|Device|conventional hemodialysis|
16071195|NCT02374372|Device|hemodiafiltration On-line|
16071196|NCT02374359|Other|follow-up|
16071197|NCT02374333|Biological|huCART19|
16071198|NCT02374320|Drug|liposomal bupivacaine|injected as an axillary block
16071199|NCT02374307|Other|Exercise and education|Exercise according to the falls prevention programme. Information on motivation, the effectiveness of falls prevention and the importance of adherence.
16071200|NCT02374294|Device|Epiflo|"EPIFLO: Small, silent disposable, battery-operated oxygen concentrator capable of delivering 98% to 100% oxygen (balance moisture) for seven days at a rate of ~3.0 ml/hour; and 60 long sterile cannula (tube) that conveys the oxygen concentrator to the area beneath the bandage overlying the wound."
16071201|NCT02374281|Drug|Glucose sucking|
16071202|NCT02374281|Drug|Water sucking|
16071203|NCT02374281|Other|No sucking|
16071204|NCT02374268|Behavioral|Exercise program alone|
16071205|NCT02374268|Dietary Supplement|Combined exercise program and nutrition supplement|
16071206|NCT02374268|Other|Waitlist control group|
16071207|NCT02374255|Behavioral|GoC intervention|Training of oncologists using OncoTalk to conduct Goals of Care discussions and measure impact on patient satisfaction.
16071357|NCT02373241|Drug|Losartan|Standard dosing
16071208|NCT02374242|Drug|Nivolumab|Nivolumab is a fully human monoclonal antibody directed against the negative immunoregulatory human cell surface receptor PD-1 (programmed death-1 or programmed cell death-1/PCD-1) with immunopotentiation activity.
16071209|NCT02374242|Drug|Ipilimumab|Ipilimumab is a recombinant, human monoclonal antibody that binds to the cytotoxic T lymphocyte-associated antigen 4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activation. Ipilimumab binds to CTLA-4 and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation. The mechanism of action of ipilimumab's effect in patients with melanoma is indirect, possibly through T-cell mediated anti-tumour immune responses.
16071210|NCT02374229|Procedure|Surgical ablation of ganglion plexus pulmonary artery.|Performed ablation zone pulmonary artery bifurcation, at 2mm proximal direction and a distal direction in the left and right branches of the pulmonary artery using the electrophysiological device Atricure.
16071211|NCT02374229|Procedure|mitral valve surgery|The standard procedure for mitral regurgitation or stenosis, the procedures will be a valve repair or mitral valve replacement, depending upon the particular morphological condition of the mitral valve.
16071212|NCT02374216|Procedure|Insertion of dental implants|Evaluation of the failure rate of all dental implants, of any brand, inserted between September 1st 2014 to August 31st 2017
16071213|NCT02374203|Dietary Supplement|high protein enteral nutrition|supply protein over 1.5 gm/kg body weight
16071214|NCT02374190|Other|Standard Hospital Care|We described patient characteristics using percentages for categorical data, means and SD or medians and IQRs for normally and non-normally distributed continuous variables, respectively. Statistical comparisons for differences in baseline characteristics among patients admitted during regular hours and off-hours were performed using χ2 tests for categorical variables, t-tests and Wilcoxon rank sum tests for normally and non-normally distributed continuous variables, respectively. DTB times were described using median and IQR based on time of admission. All p values were calculated as two-tailed analyses, using a significance level of 5%.
16071215|NCT02374164|Drug|Febuxostat XR|Febuxostat XR capsules
16071216|NCT02374151|Device|Electrohysterography|The EHG uses a Graphium electrode patch that is applied to the abdomen and records electrical activity non-invasively
16071217|NCT02374138|Behavioral|Parental stress management|"The intervention for this study is a multi-dimensional stress management program designed to be responsive to parent and other stakeholder preferences. The intervention will have two separate yet coordinated components: one-on-one stress management sessions and peer group sessions led by community wellness coaches."
16071218|NCT02374138|Other|Usual Care|IMPACT DC Asthma Clinic intervention of guideline-based clinical care, education, and short-term care coordination
16071219|NCT02374125|Device|Diacutaneous Fibrolysis|Applied only around teres major muscle.
16071220|NCT02374125|Other|Trigger Point Pressure Release|Applied only in teres major muscle trigger points.
16071221|NCT02374125|Other|Protocolized physiotherapy|Exercises, TENS and cryotherapy
16071222|NCT02374112|Dietary Supplement|Creatine|Creatine supplementation
16071223|NCT02374112|Other|Placebo|Placebo supplementation
16071224|NCT02374099|Drug|CC-486|Each cycle will be 28 days. CC-486 will be administered orally at a dose of 300 mg daily on days 1-21 of each 28-day cycle
16071225|NCT02374099|Drug|Fulvestrant|Fulvestrant will be administered by intramuscular (IM) injection at a dose of 500 mg on days 1 and 15 of cycle 1 and day 1 of subsequent cycles.
16071226|NCT02374086|Behavioral|Exercise training|
16071227|NCT02374073|Other|Functional Massage|The functional massage is a manual therapy technique, indicated in cases of painful muscle tightness that combines a rhythmical and non painful passive joint mobilization in the direction of muscle stretching together with compression/decompression of the muscle to be treated.
16071228|NCT02374073|Other|Protocolized physiotherapy|therapeutic exercises, analgesic electrotherapy and cryotherapy
16071229|NCT02374060|Drug|Periocular triamcinolone 40 mg|Periocular triamcinolone acetonide, 40 mg injection may be given either by posterior sub-Tenon's approach or by the orbital floor approach, as both appear to have similar efficacy; the approach to the periocular injection will be recorded for analysis if needed.
16071230|NCT02374060|Drug|Intravitreal triamcinolone 4 mg|Intravitreal triamcinolone acetonide, 4 mg injection procedures should be carried out under controlled aseptic conditions which include the use of sterile gloves and a sterile eyelid speculum (or equivalent). Adequate anesthesia and a broad-spectrum microbicide such as betadine, applied to the periocular skin, eyelid and ocular surface are required prior to an intravitreal injection.
16071231|NCT02374060|Drug|Dexamethasone intravitreal implant|• Standard preparation as described for intravitreal injections.
16071232|NCT02374047|Drug|CAT-2054|
16071233|NCT02374047|Drug|Placebo|
16071234|NCT02374047|Drug|CAT-2054-C|
16071235|NCT02374047|Drug|Atorvastatin|
16071236|NCT02374034|Other|Corrective exercise|Participants were assigned to either the exercise group, which performed Egoscue corrective exercises for two weeks, or the control group, which did not receive any treatment for two weeks.
16071237|NCT02374021|Drug|Methotrexate|Subjects entering trial will continue on MTX dose of at least 15mg MTX/week. At the discretion of the treating rheumatologist, may be switched to SQ route.
16071238|NCT02374021|Drug|Sulfasalazine|1 gm bid
16071239|NCT02374021|Drug|Hydroxychloroquine|200 mg twice daily, not to exceed 6.5mg/kg
16071240|NCT02374021|Drug|Etanercept|50 mg SC weekly
16071241|NCT02374021|Drug|Adalimumab|40 mg SQ every other week
16071242|NCT02374008|Drug|Ropivacaine|
16071243|NCT02373995|Biological|LAB4|Additional treatment with the specific LAB4 probiotic preparation
16071244|NCT02373956|Device|MELECTIS G|The experimental medical device (MELECTIS G) is an association of selected honey and pharmaceutical grade hyaluronic acid.
16071245|NCT02373956|Procedure|Usual care|Patients will receive usual care according to the current procedures at the Nîmes University Hospital (ICMD010 concerning pressure sore care and SCMD002 concerning referenced anti-pressure sore dressings).
16071246|NCT02373943|Other|β-carotene biofortified maize|Determination of all-trans retinol AUC values after the ingestion of 200 g porridge made with 50 g of flour of β-carotene fortified maize
16071247|NCT02373943|Other|β-carotene supplemented maize|Determination of all-trans retinol AUC values after the ingestion of 200 g porridge made with 50 g of flour of β-carotene supplemented maize
16071248|NCT02373943|Other|Normal (non biofortified) maize without added β-carotene|Determination of all-trans retinol AUC values after the ingestion of 200 g porridge made with 50 g of flour of normal maize
16071249|NCT02373930|Drug|DTG 50 mg|Dolutegravir will be supplied as a white, film-coated, round tablet with a unit dose strength of 50 mg to be administered orally
16071250|NCT02373930|Drug|RPV 25 mg|Rilpivirine will be supplied as a white to off-white, film-coated, round biconvex tablet with a unit dose strength of 25 mg to be administered orally
16071251|NCT02373930|Drug|DTG/RPV 50 mg/25 mg: Product Code AS|DTG/RPV will be supplied as a pink, film coated, round biconvex tablet with a unit dose strength of 50 mg DTG and 25 mg RPV to be administered orally
16071252|NCT02373930|Drug|DTG/RPV 50 mg/25 mg: Product Code AM|DTG/RPV will be supplied as a pink, film coated, oval, biconvex tablet with a unit dose strength of 50 mg DTG and 25 mg RPV to be administered orally
16071253|NCT02373930|Drug|DTG/RPV 50 mg/25 mg: Product Code AQ|DTG/RPV will be supplied as a pink, film coated, round, biconvex tablet with a unit dose strength of 50 mg DTG and 25 mg RPV to be administered orally
16071254|NCT02373930|Drug|DTG/RPV 50 mg/25 mg: Product Code AK|DTG/RPV will be supplied as pink, film coated, oval, biconvex tablet with a unit dose strength of 50 mg DTG and 25 mg RPV to be administered orally
16071255|NCT02373930|Drug|DTG/RPV 50 mg/25 mg: Product Code AR|DTG/RPV will be supplied as a pink, film coated, round, biconvex tablet with a unit dose strength of 50 mg DTG and 25 mg RPV to be administered orally
16071256|NCT02373904|Device|Photodynamic Bone Stabilization System|Treatment of impending and actual pathological fractures of the humerus
16071257|NCT02373891|Drug|Surfolase CR|T1: Surfolase CR (Acebrophylline 200mg) administration after fat intake Surfolase CR(Acebrophylline 200mg) administrated fasting or fat intake at D1 and D8 a.m. 8:00
16071258|NCT02373891|Drug|Surfolase CR|T0: Surfolase CR(Acebrophylline 200mg) fasting administration Surfolase CR(Acebrophylline 200mg) administrated fasting or fat intake at D1 and D8 a.m. 8:00
16071259|NCT02373878|Behavioral|Telecoaching plus Plate|A wellness coach proactively contacted the participants every two weeks during treatment, using motivational interviewing. In addition, she provided a portion control plate.
16071260|NCT02373878|Behavioral|Usual Care|Subjects were provided with institutional pamphlets on healthy eating and exercise habits
16071261|NCT02373865|Drug|Sitagliptin|Sitagliptin will be given in a daily dosage of 100 mg
16071262|NCT02373865|Drug|Glimepiride|Glimepiride will be given in a starting daily dosage of 1 mg which will be adapted up to 6 mg
16071263|NCT02373865|Drug|Sitagliptin-Placebo|Sitagliptin-Placebo will be given additional to Glimepiride (blinded). It will be given in a daily dosage of 100 mg
16071264|NCT02373865|Drug|Glimepiride-Placebo|Glimepiride-Placebo will be given additional to Sitagliptin (blinded). It will be given in a starting daily dosage of 1 mg which will be adapted up to 6 mg
16071265|NCT02373852|Device|Saphenous vein graft (SVG) stenting|Opening and stenting of blocked SVG with the use of the WIRION embolic protection filter
16071266|NCT02373839|Other|Measurement of PlGF|If lower than 100 pg/mL labour will be inducted at the moment of diagnosis. Otherwise standard monitoring will be done with labour induction at 37 weeks
16071267|NCT02373813|Drug|etanercept pre-filled syringe subcutaneous injection|etanercept for injection in pre-filled syringes
16071268|NCT02373813|Drug|Oral methotrexate|"During the open-label run-in period, methotrexate will be provided as 2.5 mg tablets.
~During the double-blind treatment period, methotrexate will be provided as 2.5 mg capsules."
16071269|NCT02373813|Drug|Placebo for etanercept subcutaneous injection|etanercept placebo for injection in pre-filled syringes
16071270|NCT02373813|Drug|Placebo for methotrexate|methotrexate placebo capsules
16071271|NCT02373813|Dietary Supplement|Folic acid (non-investigational product)|Folic acid 5 to 7 mg per week as per investigator judgment or according to local standard of care.
16071272|NCT02373800|Device|Cervical ultrasound with elastography|Following routine vaginal exam with determination of Bishop's score, cervical ultrasound with elastography will be used to determine a cervical hardness score varying from 1 to 10. Patients are then hospitalized and labor induced 12 to 48 hours after the elastography.
16071273|NCT02373787|Device|creos xenoprotect|Implant placement with simultaneous bone augmentation
16071274|NCT02373787|Device|Bio-Gide|resorbable collagen membrane
16071275|NCT02373774|Device|Ultrasound|Patients will receive an ultrasound prior to lumbar puncture procedure to help visualize and select spinal interspace.
16071276|NCT02373761|Device|Stryker Triathlon Tritanium primary knee|
16071277|NCT02373748|Device|BioGaming YuGo System|Subjects will perform a customized training program predefined in the BioGaming YuGo system.
16071278|NCT02373735|Other|crystalloid|Group A (SVV <10%): infuse crystalloid 6-10 ml/kg/hr during surgery. Group B (SVV 10-20%): infuse crystalloid 2-4 ml/kg/hr until cystectomy, 6-10 ml/kg/hr after cystectomy
16071279|NCT02373735|Other|colloid|Group A (SVV <10%): infuse colloid 200 ml if SVV is ≥ 10%. Group B (SVV 10-20%): infuse colloid 200 ml if SVV is > 20%
16071280|NCT02373735|Other|mannitol|Group B (SVV 10-20%): infuse mannitol 0.5 g/kg if SVV is < 10%
16071281|NCT02373735|Other|lasix|Group B (SVV 10-20%): infuse lasix 5 mg if SVV is < 10%
16071282|NCT02373722|Procedure|Mohs Surgery|Undergo Mohs surgery
16071283|NCT02373722|Other|Internet-Based Intervention|Watch website application based educational video
16071284|NCT02373722|Behavioral|Telephone-Based Intervention|Receive text messages
16071285|NCT02373722|Other|Educational Intervention|Watch website application based educational video
16071286|NCT02373722|Behavioral|Exercise Intervention|Use Fitbit
16071287|NCT02373722|Other|Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment|Applied to the wound area
16071288|NCT02373722|Other|Questionnaire Administration|Ancillary studies
16071289|NCT02373722|Other|Survey Administration|Ancillary studies
16071290|NCT02373683|Device|Vapotherm-Heliox|Following separation from mechanical ventilation, patient is placed on heliox (70% oxygen-30% helium) delivered with Vapotherm, a proprietary heated, humidified, high-flow nasal cannula delivery system.
16071291|NCT02373670|Behavioral|Promotion of positive deviance behaviors|Using locally derived positive deviance findings to inform a behavioral intervention
16071292|NCT02373670|Behavioral|Promotion of healthy behaviors|Using standardized healthy behavior education (EatPlayGrow curriculum from NHLBI)
16071293|NCT02373657|Behavioral|instruction in soap-making and hygiene education|
16071294|NCT02373644|Other|HVLA Thrust Manipulation and DN|HVLA thrust manipulation targeting primarily the lumbar articulations and sacroiliac joint. Up to 10 sessions over 6 weeks. At least one session of dry needling to the lumbo-pelvic muscles and peri-articular ligaments of the SI joint.
16071295|NCT02373644|Other|Conventional Physical Therapy|Therapeutic exercise and manual therapy, up to 10 sessions over 6 weeks. Patients may receive interferential current and moist heat.
16071296|NCT02373631|Other|Dry Needling, Conventional PT|Dry needling to the knee and conventional physical therapy (stretching, ROM, strengthening), 1-2 treatments per week X6 weeks (up to 10 sessions total)
16071297|NCT02373631|Other|Conventional PT|Conventional physical therapy to include knee stretching, range of motion, and strengthening exercises,1-2 treatments per week X6 weeks (up to 10 sessions total)
16071298|NCT02373618|Other|DN and conventional PT|Dry needling to the foot and lower leg. Up to 8 sessions over 4 weeks. Also conventional PT including: ultrasound, stretching, strengthening, cryotherapy and manual therapy to the foot and lower leg.
16071299|NCT02373618|Other|Conventional PT|Conventional physical therapy includes ultrasound, strengthening, cryotherapy, and manual therapy up to 8 sessions over 4 weeks.
16071300|NCT02373605|Other|Dry Needling,Thrust Manipulation|HVLA thrust manipulation to upper cervical and upper thoracic regions. Dry needling to cervicothoracic and craniofacial regions. Up to 8 treatment sessions over 4 weeks.
16071301|NCT02373605|Other|Exercise,Non-thrust Mobilization|Non-thrust mobilization and exercise to upper cervical and upper thoracic regions. Up to 8 treatment sessions over 4 weeks.
16071302|NCT02373592|Behavioral|SMS and voice messaging|"This group will receive reminders to use the TempStat (two messages) and promote foot care (six messages). The content of these eight messages have been developed and validated their delivery through both, SMS and voice messaging.
~During the first two weeks of the intervention, only reminders to use the TempStat will be sent, daily, Monday to Friday, both via SMS and voice messaging.
~Hereafter, for the remaining 76 weeks, patients will only receive two messages per week, one SMS and one voice message, alternating content (reminders to use TempStat and promotion of foot care)."
16071303|NCT02373592|Device|Thermometry|Subjects will be provided with a TempStat (foot thermometer), a device that captures a thermal image of feet. (See Detailed description)
16071304|NCT02373579|Drug|Omega-3 Fatty Acids|"study group, included standard risk ALL pediatric patients who were supplemented with oral omega-3 capsule (one capsule / day) .
~Omega-3 was supplied as soft gelatin capsules in a dose of 1000 mg of omega-3 fatty acids/day ."
16071305|NCT02373579|Drug|Methotrexate|control group, included pediatric patients with standard risk acute lymphoblastic leukemia in maintenance phase day 0 and receiving oral Methotrexate (20 mg / m2) weekly without any supplementation .
16071306|NCT02373566|Device|Novomaix dermal substitute in combination with STSG|Novomaix dermal substitute in combination with STSG
16071307|NCT02373553|Other|EXERCISES|The postural reeducation in a sitting position, in ventral and dorsal recumbency, including manual techniques, stretching the sternocleidomastoid and scalene muscles. Exercises for pelvic girdle positioning and stretching the hamstrings muscles tibial and sural triceps are associated with respiratory exercise. Twice a week during 3 months
16071308|NCT02373553|Other|HEALTH EDUCATION|Booklet contain many pictures demonstrating some exercises and an importance to do it.
16071309|NCT02373540|Device|Algovita Spinal Cord Stimulation system|
16071310|NCT02373527|Other|No Fasting prior to catheterization|No restriction for oral intake
16071311|NCT02373514|Drug|Paracetamol|1 gr paracetamol in 100 ml saline with rapid infusion
16071312|NCT02373514|Drug|Dexketoprofen|50 mg dexketoprofen in 100 ml saline with rapid infusion
16071313|NCT02373501|Procedure|Intra-abdominal repair|Intra abdominal repair of uterine incision
16071314|NCT02373501|Procedure|Extra-abdominal repair|Extra abdominal repair of uterine incision
16071315|NCT02373488|Other|lifestyle advice|lifestyle advices such as increasing fluid and fibre intake, improving physical activity level, and taking the ideal posture for defecation (squatting position) with a two-pages document.
16071316|NCT02373488|Other|connective tissue manipulation|CTM wil be applied five days per week, a total of 20 sessions for 4 weeks. Each session lasted around 15-20 minutes. While patients are in a sitting position, starting from the lumbosacral region, lower thoracic, scapular, inter-scapular and cervical regions will be included in the treatment, respectively.
16071317|NCT02373488|Other|abdominal massage|Abdominal massage will be applied five days a week for four weeks. Each session will last around 15-20 minutes.
16071318|NCT02373475|Other|Conventional ventilation|Conventional ventilation with TV of 10 mL/kg predicted body weight (PBW) without positive end-expiratory pressure (PEEP) during the surgery under general anesthesia
16071319|NCT02373475|Other|Protective lung ventilation|Protective lung ventilation with TV of 6 mL/kg PBW, PEEP of 6 cmH2O and recruitment maneuver during the surgery under general anesthesia
16071320|NCT02373462|Drug|Olmesartan|
16071321|NCT02373462|Drug|other anti-hypertensive drug|CCB, diuretics, alpha blocker, direct vasodilator, beta blocker
16071322|NCT02373449|Other|RS-fMRI|Resting State-functional Magnetic Resonance Imaging. Protocols involving BOLD (blood oxygen level-dependent) and non-BOLD techniques will be used.
16071323|NCT02373449|Drug|Ketamine|Part of standard care. To be performed over five consecutive days (Monday to Friday) for six hours per day. A therapeutic range of 0.5 to 2.0 mg/kg/hour is targeted.
16071324|NCT02373436|Other|Constraint Induced Therapy|"They will be instructed to remain with the mitt in UL less affected by 90% of the hours in which to stay awake beyond the training period.
~The training will consist of 30 minutes for the transfer package, interview by items of MAL, and 2 hours and 30 minutes with four tasks of Shaping, and Task Practice.
~The Transfer Package consists of a compromise agreement, held at the end of the first day of practice, in which the individual undertakes to complete:
~The Shaping is a training method that makes it difficult gradually according to the motor capacity of each individual. It will be taken care of including tasks using all joints (shoulder, elbow, wrist and fingers), giving priority to the individual in need.
~The individual will be instructed not to remove the trunk of the chair, and each task is repeated 10 times in no more than 45s.
~The Task Practice promotes increased motor function during functional activities. For all individuals will be held the same function: meal."
16071358|NCT02373241|Drug|Losartan|Experimental dosing
16071726|NCT02370589|Biological|Matrix-M Adjuvant|
16071325|NCT02373436|Other|Control|This group has no intervention. They will wear a mitt that don't limit the use of the fingers and wrist. This is only to ensure blinding of the measurer
16071326|NCT02373423|Other|Advocacy|See above for description
16071327|NCT02373410|Procedure|Umbilicus|"Depending on the height of the operating table, the insertion angle of the spinal needles would be vary. The investigators intend to find the optimal angle and the height of the table to provide that.
~The height of the operating table which set at the needle insertion point of anesthetists; the level of umbilicus"
16071328|NCT02373410|Procedure|Lowest rib margin|The height of the operating table which set at the needle insertion point of anesthetists; the level of lowest rib margin
16071329|NCT02373410|Procedure|Xiphoid|The height of the operating table which set at the needle insertion point of anesthetists; the level of xiphoid
16071330|NCT02373410|Procedure|Nipple|The height of the operating table which set at the needle insertion point of anesthetists; the level of nipple
16071331|NCT02373410|Drug|Umbilicus Bupivacaine|If freely flowing of CSF is detected, appropriate dose of MARCAINE was injected in all interventional groups.
16071332|NCT02373410|Drug|Lowest rib margin Bupivacaine|If freely flowing of CSF is detected, appropriate dose of MARCAINE was injected in all interventional groups.
16071333|NCT02373410|Drug|Xiphoid Bupivacaine|If freely flowing of CSF is detected, appropriate dose of MARCAINE was injected in all interventional groups.
16071334|NCT02373410|Drug|Nipple Bupivacaine|If freely flowing of CSF is detected, appropriate dose of MARCAINE was injected in all interventional groups.
16071335|NCT02373397|Device|Cacicol20|Investigational device, regenerating agent, single-use doses, topical eye drops. Indicated for corneal wound healing.
16071336|NCT02373397|Device|Placebo|Vehicle only in identical packaging, with identical dosage and administration route.
16071337|NCT02373384|Drug|Oral alkalinization (Potassium citrate, Allopurinol)|"Eligible patients, who fulfilled the study criteria, will be instructed For; Oral alkalinization therapy
~Potassium citrate 20 mEq three times daily
~Hyperuricosuric patients (24-hours urine uric acid more than 750 mg/day in male and more than 650mg/day in females) will receive:
~Allopurinol, a competitive inhibitor of xanthine oxidase, in a dose of 300 mg daily."
16071338|NCT02373384|Behavioral|Life style modification|"Eligible patients, who fulfilled the study criteria, will be also instructed for;
~Adequate fluid intake in order to maintain urine volume between 2-3 L per day."
16071339|NCT02373384|Dietary Supplement|Dietary recommendations (decrease purine rich diet as red meat and fish, increase vegetables)|Eligible patients, who fulfilled the study criteria and they are hyperuricosuric (24-hours urine uric acid more than 750 mg/day in male and more than 650mg/day in females) will be also instructed for; Dietary modification will be advised in the form of decrease purine rich diet as red meat and fish, increase vegetables.
16071340|NCT02373371|Drug|Metvix®|
16071341|NCT02373371|Procedure|Photodynamic Therapy Blue light|Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a blue light source to activate the applied drug
16071342|NCT02373371|Procedure|Photodynamic Therapy Daylight|Photodynamic therapy (PDT) is a medical treatment that utilizes a photosensitizing molecule (Metvix) and a the day light to activate the applied drug
16071343|NCT02373358|Behavioral|Group yoga intervention|Participants will participate in 6 90-minute yoga groups designed to promote themes related to trauma recovery (safety & boundaries, strength & power, assertiveness, intuition, trust, & community) using mindfulness, breath work, and physical yoga poses.
16071344|NCT02373332|Other|omega-3 and -6 fatty acids and their 12-LOX oxylipins|platelets from healthy subjects and T2DM patients will be isolated from their blood and treated with omega-3 and -6 fatty acids and their 12-LOX oxylipins of those fatty acids followed by assessment of protection from agonist-induced platelet activation and thrombosis
16071345|NCT02373319|Behavioral|CV-screening-1 plus personalized|Cardiovascular risk screening supervised by health professional - 15 minutes wash-out - Self-screening of cardiovascular risk; Communication of personalized recommendations according to the health exam results for the control of cardiovascular risk factors
16071346|NCT02373319|Behavioral|CV-screening-2 plus personalized|Self-screening of cardiovascular risk - 15 minutes wash-out - Cardiovascular risk screening supervised by health professional; Communication of personalized recommendations according to the health exam results for the control of cardiovascular risk factors
16071347|NCT02373319|Behavioral|CV-screening-1 plus standard|Cardiovascular risk screening supervised by health professional - 15 minutes wash-out - Self-screening of cardiovascular risk; Standard communication of the health exam results
16071348|NCT02373319|Behavioral|CV-screening-2 plus standard|Self-screening of cardiovascular risk - 15 minutes wash-out - Cardiovascular risk screening supervised by health professional; Standard communication of the health exam results
16071349|NCT02373306|Procedure|Sustained or hemodynamically unstable arrhythmia induction during non-invasive programmed stimulation|
16071350|NCT02373280|Drug|10 day sequential therapy (Esomeprazole, amoxicillin, clarithromycin, metronidazole)|In this group, patients will receive the 10 day sequential regimen for eradication of H. pylori. 10 day sequential regimen is like follows; Esomeprazole 40 mg bid 10 days (D1-D10)+amoxicillin 1 g bid 5 days (D1-D5)+clarithromycin 500 mg bid 5 days (D6-D10)+metronidazole 500 mg tid 5 days (D6-D10).
16071351|NCT02373280|Drug|7 day tailored PPI triple therapy (clarithromycin-containing triple therapy)|the participants received PPI based triple therapy[Esomeprazole 40 mg bid 7 days (D1-D7)+amoxicillin 1000mg bid 7 days (D1-D7)+clarithromycin 500mg bid 7 days (D1-D7)]
16071352|NCT02373280|Drug|7 day moxifloxacin based triple therapy [Esomeprazole, Moxifloxacin, Amoxicillin]|moxifloxacin triple therapy [Esomeprazole, 40 mg bid 7 days (D1-D7)+Moxifloxacin, 400 mg qd 7 days (D1-D7)+Amoxicillin 1 g bid 7 days (D1-D7)].
16071353|NCT02373280|Drug|7 or 14 days tailored EBMT therapy group (bismuth quadruple therapy)|bismuth quadruple therapy [Esomeprazole, 40 mg bid 7 days (D1-D7)+amoxicillin 1 g bid 7 days (D1-D7)+clarithromycin 500mg bid 7 days (D1-D7)], bismuth quadruple therapy [Esomeprazole, 40 mg bid 7 days (D1-D7)+Tri potassium dicitrate bismuthate, 300 mg qid 7 days (D1-D7)+Metronidazole, 500 mg tid 7 days (D1-D7)+Tetracycline 500 mg qid 7 days (D1-D7)] If there was no metronidazole resistance, the treatment was 7 days in duration. If metronidazole resistance was evident, treatment duration was 14 days.
16071354|NCT02373267|Biological|Technozyme|determination of ADAMTS13 activity
16071355|NCT02373254|Drug|Ibuprofen|Ibuprofen 400 mg and 800 mg
16071356|NCT02373254|Drug|Acetaminophen/hydrocodone|Norco 5/325 mg and 10/325 mg
16071359|NCT02373228|Other|Audio signal processing (applied offline before playback)|
16071360|NCT02373215|Drug|Nalbuphine HCL ER|Nalbuphine HCL extended release tablet
16071361|NCT02373202|Drug|Sarilumab|Pharmaceutical form:solution
16071362|NCT02373202|Drug|Sulfasalazine|Pharmaceutical form: Tablet Route of administration: Oral
16071363|NCT02373202|Drug|Leflunomide|Pharmaceutical form: Tablet Route of administration: Oral
16071364|NCT02373202|Drug|Bucillamine|Pharmaceutical form: Tablet Route of administration: Oral
16071365|NCT02373202|Drug|Tacrolimus|Pharmaceutical form: Capsule Route of administration: Oral
16071366|NCT02373202|Drug|Mizoribine|Pharmaceutical form: Tablet Route of administration: Oral
16071367|NCT02373189|Device|Bright light|The purpose of this R34 Pilot and Feasibility study is to develop a morning bright light treatment to help manage chronic pain and improve PTSD symptoms, mood, and sleep in US veterans. Veterans will have 7 baseline days at home, followed by a baseline pain sensitivity assessment and baseline home circadian phase assessment (dim light melatonin onset). Following an instructional home visit, patients will then self-administer morning bright light treatment for 6 days, followed by reassessments of pain sensitivity and home circadian phase. This will be repeated after a further 7 days of morning bright light treatment. The Patient Reported Outcomes Measurement Information System (PROMIS) will also be administered at every lab visit. Additionally, pain and mood (electronic diaries) and sleep (wrist actigraphy) will be assessed daily throughout baseline and treatment. Pain, mood and sleep will also be self-reported daily during a 1 month follow up after cessation of light treatment.
16071368|NCT02373176|Drug|[14C]PRC 4016 (Icosabutate)|Single oral dose
16071369|NCT02373163|Drug|Hydrochlorothiazide|Arm: Active Comparator: Diuretic Therapy with hydrochlorothiazide (25 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Calcium-channel blocker Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM Arm: Active Comparator: Angiotensin Receptor Blocker Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
16071370|NCT02373163|Drug|Amlodipine|Therapy with amlodipine (10 mg daily) taken once daily between 6 and 8 AM
16071371|NCT02373163|Drug|Telmisartan|Therapy with Telmisartan (80 mg daily) taken once daily between 6 and 8 AM
16071372|NCT02373150|Drug|Imeglimin|
16071373|NCT02373150|Drug|Placebo|
16071374|NCT02373137|Procedure|DSAEK|
16071375|NCT02373137|Procedure|DMEK|
16071376|NCT02373137|Device|Endoserter|The Endoserter, a corneal endothelium device, is an approved FDA device. This will be used to insert and position the graft into the anterior chamber during endothelial replacement surgery. It is a sterile, single-use instrument.
16071377|NCT02373137|Drug|Prednisolone|Prednisolone is a corticosteroid used to alleviate swelling post-surgery.
16071378|NCT02373137|Drug|Ofloxacin|Ofloxacin is an antibiotic used to treat bacterial infections of the eye.
16071379|NCT02373137|Drug|Tropicamide|Tropicamide is a prescription drug used to dilate pupils during an eye exam.
16071380|NCT02373137|Drug|Phenylephrine|Phenylephrine is a prescription drug used to dilate pupils during an eye exam.
16071381|NCT02373137|Device|Jones Tube|The Jones Tube will be used to insert the graft into a 3.5 mm corneal incision during endothelial replacement surgery.
16071382|NCT02373124|Drug|infusion of NMDA antagonist|52 minute infusion
16071383|NCT02373111|Dietary Supplement|Isoflavone|
16071384|NCT02373111|Dietary Supplement|Astaxanthin|
16071385|NCT02373111|Dietary Supplement|Placebo|
16071386|NCT02373098|Drug|Fingolimod 0.5 mg|66 relapsing remitting MS (RRMS) patients were recruited. Patients who met all inclusion and none of the exclusion criteria were treated by Fingolimod 0.5 mg.
16071387|NCT02373085|Other|Antibiotic adjusted to antibiogram|A course of 3-14 days of antimicrobial treatment, according to the antibiogram results, will be prescribed for every episode of asymptomatic bacteriuria during the first 2 years after transplantation.
16071388|NCT02373072|Drug|PF-06649751|Subjects completing all three treatment periods will be administered two doses. Doses: 0.75mg, 1.5mg, 3mg, 6mg, 9mg. Tablets in the form of 0.25mg or 1 mg.
16071389|NCT02373072|Drug|Trimethobenzamide Hydrochloride|300mg TID, Capsules. Optional in both Cohorts.
16071390|NCT02373072|Drug|Placebo|Subjects completing all three treatment periods will be receiving placebo once.
16071391|NCT02373059|Other|Diabetes Issue Cards Decision Aids|
16071392|NCT02373059|Other|Usual Pharmaceutical Care|
16071393|NCT02373046|Drug|LX4211|Single dose of LX4211 400 mg as 1 × 400-mg tablet Day 1 or Day 9
16071394|NCT02373046|Drug|LX4211|Single dose of LX4211 400 mg as 2 × 200-mg tablets on Day 1 or Day 9
16071395|NCT02373033|Other|Natural food folate|Consumed folate-rich foods (providing additional 250 μg/d folate).
16071396|NCT02373033|Other|Folic acid|Received a folic acid supplement (providing additional 500 μg/d folic acid).
16071397|NCT02373033|Other|Apple juice|Received apple juice containing no folate or folic acid.
16071398|NCT02373020|Other|colonoscopic biopsies|
16071399|NCT02373007|Procedure|Scopinaro Surgery|Classic Scopinaro Technique is a bariactric surgery that proposes the stomach will be divide in two parts: a proximal part and a distal part for performing horizontal gastrectomy. Differently what will happen in the Modified Scopinaro Surgery that will divide the stomach in two parts: a proximal part and a distal part for performing gastroplasty.
16071400|NCT02372994|Other|Loop|Loop is a secure online communication system centered on the patient that assembles the patient's actual healthcare team for ongoing collaborative care. The patient and caregiver are integral members of the team. Loop is cross-organizational, cross-setting and interprofessional. It is for ongoing, interactive, contextual, team-based communication. Loop is explicitly for asynchronous communication, not instant messaging. The stream of messages is stored and can be sorted for ease of viewing. The tool was developed with user-centred design and requires no prior training.
16071401|NCT02372981|Device|mucopexy +/- Doppler-guided haemorrhoidal artery ligation|Mucopexy with or without DG-HAL is performed using a specific device consisting of a proctoscope equipped with a Doppler probe and a light source. The proctoscope model in our study has a sliding part comprising the operating window and Doppler probe for better proximal and distal movement without repositioning the proctoscope during mucopexy.
16071402|NCT02372968|Other|Full body composition and of plasma and urine metabolites|"Full body composition in lean, fat and bone mass will be assessed from DXA scans.
~Plasma and urine metabolites will be measured using metabolomics"
16071403|NCT02372955|Drug|dapagliflozin|subjects will be randomly assigned to receive dapagliflozin 10 mg daily
16071404|NCT02372955|Drug|glimpiride|subjects will be randomly assigned to receive glimpiride 4 mg daily
16071405|NCT02372942|Drug|Lattoferrin|515 pregnant women using lattoferrin to prevent preterm delivery
16071406|NCT02372942|Drug|Progesterone|515 pregnant women using lattofferrin to preventf preterm delivery lattoferrin or progesterone
16071407|NCT02372929|Procedure|Endoscopic Ultrasound|Esophageal cancer patients will be staged by endoscopic ultrasound. All patients will undergo upper endoscopy prior to endoscopic ultrasound.
16071408|NCT02372916|Drug|Ranibizumab|The medication Ranibizumab is routine standard of care for patients with wet AMD, and this is not an aspect of the study that is considered novel intervention
16071409|NCT02372903|Drug|Administration of micronized Palmitoylethanolamide (PEA)- Transpolydatin|Palmitoylethanolamide 600 mg twice daily for 10 days sublingually and oral palmitoylethanolamide 400 mg and polydatin 40 mg, twice daily for 90 days
16071410|NCT02372877|Device|Amicus Red Cell Exchange in SCD patients|Each patient will be treated with one RBCx procedure using the AMICUS RBCx System
16071411|NCT02372864|Behavioral|Mindfulness based stress reduction (MBSR)|Mindfulness based stress reduction (MBSR) is a standardized eight-week psychosocial intervention delivered by certified trainers. The programme consists of a weekly class of two and half hours for a period of eight weeks and a full retreat day. Furthermore participants are asked to practice exercises at home for 45 minutes, six days a week. The MBSR class will consist of ten to twelve persons, starting at different weekdays and moments of the day. If during the inclusion process it becomes apparent that a group of participants (provided a sufficient group size) comes from a region (e.g. Friesland or Overijssel) with a considerable amount of traveling time to the UMCG, efforts will be made to start a MBSR training in the region with trainers from the UMCG.
16071412|NCT02372851|Device|Pureit As+ Filter|The Pureit As+ water filter has been developed to effectively remove arsenic (both arsenite and arsenate) from over 300 µg/L to less than 10 µg/L in addition to removing microbial contamination (Institution of Public Health Engineers, 2011). It has an end-of-life indicator and consumables that do not re-contaminate the environment when disposed (Institution of Public Health Engineers, 2011). The technology requires no electricity, but only the replacement of the battery after 1000 L of water filtered (approximately 100 days based on a family of five drinking 2 L/day).
16071413|NCT02372838|Procedure|Microvascular fibula bone transfer|Reconstructive surgery with a microvascular bone flap
16071414|NCT02372825|Procedure|Reconstructive surgery|Reconstructive surgery with the free iliac crest flap
16071415|NCT02372812|Drug|dexamethasone|12 mg of dexamethasone
16071416|NCT02372812|Drug|Placebo|
16071417|NCT02372799|Drug|Vilazodone|
16071418|NCT02372799|Drug|Placebo|
16071419|NCT02372799|Drug|Fluoxetine|
16071420|NCT02372786|Drug|2,5% lidocaine / 2,5% prilocaine cream|The treatment area will be divided in two equal parts with white markings. Between these two areas an area of 1 cm will be marked. This area will be left untreated, to avoid possible spill-over effects of the two anaesthetic creams. A thick layer of 2,5% lidocaine / 2,5% prilocaine cream will be applied on one side to the intact skin under plastic occlusion (average of 1,5-2g per 10 cm2) 60 minutes before laser treatment.
16071421|NCT02372786|Drug|7% lidocaine / 7% tetracaine cream|The treatment area will be divided in two equal parts with white markings. Between these two areas an area of 1 cm will be marked. This area will be left untreated, to avoid possible spill-over effects of the two anaesthetic creams. A thin layer of 7% lidocaine / 7% tetracaine cream (1mm) will be applied on the other side to the intact skin (average of 1,3g Pliaglis per 10 cm2) 60 minutes before laser treatment.
16071422|NCT02372786|Device|Neodymium-doped yttrium aluminium garnet (Nd:Yag) laser|Acne keloidalis nuchae: during this study a 1064 nm Nd:yag laser with a spot size of 7-10 mm, and a fluence of 35-60J/cm2, (depending on the effective and safe clinical response), a pulse duration of 20-35 ms and 2 passes will be used.
16071423|NCT02372786|Device|Q-switched nd Yag laser|Tattoo removal: we will use a 3 mm spotsize and a fluence depending on the absorption of the laser light, which is visible as skin whitening.
16071424|NCT02372760|Device|BA by spray catheter (Olympus PW-205V)|This group will be having the bronchoscopic anesthesia (lidocaine) injected through the spray catheter (Olympus PW-205V)
16071425|NCT02372760|Other|BA classic anesthesia|This group will have the bronchoscopic anesthesia (lidocaine) injected through the bronchoscope's working channel.
16071426|NCT02372760|Drug|Anesthesia|Both groups will receive lidocaine as the anesthesia for bronchoscopy
16071427|NCT02372747|Procedure|Delta-shaped anastomosis|The patients in DS group underwent Delta-shaped anastomosis after TLDG.
16071428|NCT02372747|Procedure|Billroth II anastomosis|The patients in B-II group underwent Billroth-II anastomosis after TLDG.
16071429|NCT02372734|Other|Pediatric Quality of Life (Peds QL) Survey|The subjects will be administered the Peds QL survey. Children will also have a parental section for parental response. This is NOT an interventional study.
16071430|NCT02372708|Drug|dinitrophenyl(DNP)|
16071431|NCT02372708|Radiation|Radiation|laser irradiation was carried out for 10 min, the power density of laser irradiation was 1W/cm2
16071432|NCT02372695|Drug|Paricalcitol|
16071433|NCT02372682|Device|Shear wave sonoelastography|Sonoelastography is to be performed on the liver.
16071434|NCT02372669|Device|Chitosan nerve tube in addition to gold standard therapy|Primary microsurgical repair of traumatic lesion of sensory nerves of the hand with use of an chitosan nerve tube in addition. Clinical Follow-up will be performed after 3,6,12 and 24 months.
16071435|NCT02372669|Procedure|Gold standard Primary microsurgical repair|Primary microsurgical repair of traumatic lesion of sensory nerves of the hand. Clinical Follow-up will be performed after 3,6,12 and 24 months.
16071436|NCT02372656|Drug|Placebo gel|Placebo gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.
16071437|NCT02372656|Drug|1% Metformin|1% Metformin gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.
16071438|NCT02372656|Drug|1.2% Simvastatin|1.2% Simvastatin gel to be delivered in intrabony sites of chronic periodontitis subjects at baseline, 3,6 and 9 months.
16071519|NCT02372123|Other|connective tissue manipulation|Investigators will apply connective tissue manipulation on lumbosacral, lower thoracic, and anterior pelvic regions starting from the estimated time of ovulation until the next period begins
16071439|NCT02372643|Other|clitoral, transvaginal and transrectal ultrasound|Doppler Ultrasound assessment of clitoral hemodynamics will be performed in all subjects. Transvaginal and transrectal ultrasound will be performed in subjects giving their consent to these procedures.
16071440|NCT02372630|Drug|Linagliptin|
16071441|NCT02372630|Drug|Placebo|
16071442|NCT02372617|Procedure|periacetabular osteotomy|
16071443|NCT02372604|Drug|Levocetirizine (as levocetirizine dihydrochloride), 5mg ( then 20 mg) per day . Oral administration.|"Week 1 to week 5, every day : - the morning : 5 mg of levocetirizine (capsule)
~the evening : placebo capsule
~Week 6 to week 10, every day : - the morning : 10 mg of levocetirizine (capsule)
~the evening : 10 mg of levocetirizine (capsule))"
16071444|NCT02372604|Drug|Levocetirizine, (as levocetirizine dihydrochloride) 20 mg ( then 5 mg) per day. Oral administration.|"Week 1 to week 5, every day : - the morning : 10 mg of levocetirizine (tablet)
~the evening : 10 mg of levocetirizine(tablet)
~Week 6 to week 10, every day : - the morning : 5 mg of levocetirizine (tablet)
~the evening : placebo tablet"
16071445|NCT02372591|Drug|Buprenorphine|Intravenous injection of approximately 10 mL administered via slow push over 5 minutes. Given 4 injections during the session with each injection separated by 1.5 hours.
16071446|NCT02372591|Drug|Hydromorphone|Intravenous injection of approximately 10 mL administered via slow push over 5 minutes. Given 4 injections during the session with each injection separated by 1.5 hours.
16071447|NCT02372591|Drug|Placebo|Intravenous injection of approximately 10 mL administered via slow push over 5 minutes. Given 4 injections during the session with each injection separated by 1.5 hours.
16071448|NCT02372578|Drug|ASP3662|oral
16071449|NCT02372578|Drug|pregabalin|oral
16071450|NCT02372578|Drug|ASP3662 placebo|oral
16071451|NCT02372578|Drug|pregabalin placebo|oral
16071452|NCT02372565|Behavioral|Facebook and text Message|Culturally-relevant physical activity promotion program
16071453|NCT02372565|Behavioral|Standard Print-based Intervention|Non-culturally relevant physical activity promotion program
16071454|NCT02372552|Device|CROMA|Microwave coagulation of small blood vessels
16071455|NCT02372539|Other|Diabetes|All patients enrolled in study will be given dexamethasone for prophylaxis of chemotherapy-induced nausea and vomiting. This will already be a part of their chemotherapy regimen and will not be prescribed by study investigators
16071456|NCT02372539|Other|Control Group|All patients enrolled in study will be given dexamethasone for prophylaxis of chemotherapy-induced nausea and vomiting. This will already be a part of their chemotherapy regimen and will not be prescribed by study investigators
16071457|NCT02372526|Other|Mealtest: High protein 200 kcal 200 ml liquid meal consumed during 10 minutes|
16071458|NCT02372526|Other|Mealtest: High fat 200 kcal 200 ml liquid meal consumed during 10 minutes|
16071459|NCT02372526|Other|Mealtest: High carbohydrate 200 kcal 200 ml liquid meal consumed during 10 minutes|
16071460|NCT02372526|Other|Mealtest: High fat 200 kcal 200 ml liquid meal with pancreatic lipase inhibitor consumed during 10 minutes|
16071461|NCT02372500|Dietary Supplement|Chewing gum|Sugar free chewing gum
16071462|NCT02372487|Drug|sildenafil citrate|sildenafil citrate 25 mg every 8 hours
16071463|NCT02372487|Dietary Supplement|fluid therapy|2 liters of fluid per day
16071464|NCT02372474|Biological|Stem cell|Out of 112 high risk patients for POF diagnosis was established in 10 cases. Endometrial fractional biopsy was taken, stained with H&E stain and by Immunohistochemical (IH) staining by stem cell marker OCT4. IH expression of stem cell was evaluated before and after transplantation according to Edessy Stem Cell Scoring (ESS). After laparoscopic injection of stem cell sample in the ovaries, participants were followed up monthly for a period of one year by hormonal (FSH, LH and E2), clinical (resuming menstruation and pregnancy), US (folliculometry), histopathological (HP), and IH expression of stem cell (stem cell positivity and scoring according to ESS).
16071465|NCT02372461|Drug|Placebo|This is an non inferiority trial, the intervention is a placebo
16071466|NCT02372461|Drug|Amoxicillin|Amoxicillin Liquid
16071467|NCT02372448|Other|ALK analysis on CTCs detected by ISET|
16071468|NCT02372435|Procedure|Shortening of the interval of two-stage prosthesis exchange|The Intervention consist in shortening of the interval between Explantation and re-implantation in patients undergoing a two-stage prosthesis Exchange. Comparison between arms is performed between short and long interval before re-implantation.
16071469|NCT02372422|Other|Transvaginal ultrasound determination of cervical length|Transvaginal ultrasound was used to measure the length of the cervix from the internal to external os relying on a standard approach and clinicians caring for the patients were made aware of the results.
16071470|NCT02372422|Other|Routine care|Routine prenatal care of twins. Digital exams were permitted, but transvaginal ultrasound assessment of cervical length was not.
16071471|NCT02372409|Device|MRI-guided laser ablation|
16071472|NCT02372409|Drug|Doxorubicin|
16071473|NCT02372409|Drug|Etoposide|
16071474|NCT02372409|Device|Dynamic contrast-enhanced (DCE) MRI|
16071475|NCT02372409|Device|Dynamic susceptibility contrast (DSC) MRI|
16071476|NCT02372396|Behavioral|Compassion Meditation (CM)|Compassion meditation is a meditative practice focused on the wish that others and the self may be free of suffering. Because this particular form of meditation has been shown to elicit positive emotion and feelings of connection with other people, it is uniquely well suited to addressing PTSD, which is characterized by strong negative affect, deficits in positive emotion and social connectedness.
16071477|NCT02372396|Behavioral|Relaxation|Relaxation Training is selected as the control condition because it is a good match for nonspecific aspects of the meditative practice (e.g., attention, support, contact with a mental health provider) and it is structurally similar to meditation (e.g., restful, in session and at home exercises).
16071478|NCT02372383|Drug|Ethambutol|Anti-mycobacterial oral drug
16071479|NCT02372383|Drug|Rifampin|Anti-mycobacterial oral drug
16071480|NCT02372383|Drug|Azithromycin|Anti-mycobacterial oral drug
16071481|NCT02372383|Drug|Pancrelipase|Pancreatic enzyme replacement therapy
16071482|NCT02372370|Procedure|Microneedle pretreatment + MAL-PDT|Interventions: microneedling of the skin using dermarollers prior to topical application of 125 microliter methyl aminolevulinate (MAL) cream followed by red light illumination after 3 hours incubation (i.e. photodynamic therapy (PDT)). Three settings are applied: mild, moderate and strong.
16071483|NCT02372370|Procedure|Sandpaper pretreatment + MAL-PDT|Interventions: abrasion of the skin using Abrasive Pads for Skin Preparation prior to topical application of 125 microliter methyl aminolevulinate (MAL) cream followed by red light illumination after 3 hours incubation (i.e. photodynamic therapy (PDT)). Three settings are applied: mild, moderate and strong.
16071484|NCT02372370|Procedure|Curettage pretreatment + MAL-PDT|Interventions: curettage of the skin using a curette prior to topical application of 125 microliter methyl aminolevulinate (MAL) cream followed by red light illumination after 3 hours incubation (i.e. photodynamic therapy (PDT)). Three settings are applied: mild, moderate and strong.
16071485|NCT02372370|Procedure|Ablative Fractional Laser (AFXL) pretreatment + MAL-PDT|Interventions: Ablative Fractional Laser (AFXL) resurfacing of the skin prior to topical application of 125 microliter methyl aminolevulinate (MAL) cream followed by red light illumination after 3 hours incubation (i.e. photodynamic therapy (PDT)). Three settings are applied: mild, moderate and strong.
16071486|NCT02372370|Procedure|Non-Ablative Fractional Laser (NAFXL) pretreatment + MAL-PDT|Interventions: Non-Ablative Fractional Laser (NAFXL) resurfacing of the skin prior to topical application of 125 microliter methyl aminolevulinate (MAL) cream followed by red light illumination after 3 hours incubation (i.e. photodynamic therapy (PDT)). Three settings are applied: mild, moderate and strong.
16071487|NCT02372370|Drug|MAL Control.|Intervention: Topical application of 125 microliter methyl aminolevulinate (MAL) cream followed by red light illumination after 3 hours incubation (i.e. photodynamic therapy (PDT)).
16071488|NCT02372370|Other|Untreated Control|Untreated control. No interventions.
16071489|NCT02372357|Drug|Posaconazole prophylaxis 120 mg/m² tid|Patients are receiving posaconazole to prevent invasive fungal infections in a dose of 120 mg/m² tid
16071490|NCT02372357|Procedure|Blood sampling|During steady state treatment with posaconazole (at least 7 days), 9 blood samples are taken via a central venous catheter to evaluate the pharmacokinetics of posaconazole.
16071491|NCT02372344|Drug|AZD0585|Following an overnight fast of at least 10 hours, a single dose of 4 g AZD0585 will be administered on 3 separate occasions (fasting, before meal, and after meal) in a randomized crossover fashion with different food restrictions.
16071492|NCT02372331|Other|ERAS perioperative management|"Preop Counseling
~Preop biliary drainage (X) when Serum Total bilirubin < 14.62mg/dl and cholangitis (-)
~Preop enteral nutrition
~Oral bowel preparation (mechanical bowel preparation ) (X)
~Preop fasting < 6 hours
~Prevention of postoperative nausea and vomiting (PONV) (O)
~Nasogastric intubation (X)
~Near-zero fluid balance
~Somatostatin analogues (X)
~Postop routine artificial nutrition (X), soft diet at POD #2
~Audit
~Other items are same as conventional"
16071493|NCT02372318|Drug|Nalmefene|18mg of Nalmefen will be administered orally
16071494|NCT02372318|Drug|Placebo|Placebo tablet
16071495|NCT02372305|Biological|FlexHD|Patients will be randomized to receive FlexHD.
16071496|NCT02372305|Biological|Alloderm|Patient will be randomized to receive Alloderm.
16071497|NCT02372292|Drug|intravenous furosemide|Decongestant therapy for decompensated heart failure which may be administrated as intravenous bolus or infusion
16071498|NCT02372279|Other|Embryo observation|In EO group, conventional observations will be made.
16071499|NCT02372266|Other|Early Maternal-Newborn Infant Discharge|Discharge from the hospital between 12-24 hours of life
16071500|NCT02372266|Other|Routine discharge|Discharge of the mother and newborn 2 to 3 days after delivery
16071501|NCT02372253|Drug|Verapamil|
16071502|NCT02372253|Drug|Placebo|
16071503|NCT02372240|Drug|VLX1570 and dexamethasone|
16071504|NCT02372227|Drug|VS-5584 and VS-6063|Starting dose of VS-5584 will be 20mg taken once daily, 3x/week of each 21 day cycle. All subjects will also receive 2x/day treatment with 400mg VS-6063 in 21 day cycles. Number of Cycles: until progression or unacceptable toxicity develops.
16071505|NCT02372214|Procedure|Training|Patients will have their aneurysm impressed by a 3D printing. The senior vascular surgeon and the residents of this group will be able to practice the procedure in the model as many times as they wish before the surgery. After the training, the EVAR will be performed according to the routine of the hospital.
16071506|NCT02372201|Other|Hydro Colon Therapy plus probiotic|Probiotic intervention was done after 2-5 cycles of hydro colon therapy.
16071507|NCT02372188|Other|water|Control
16071508|NCT02372188|Dietary Supplement|caffeine|
16071509|NCT02372188|Dietary Supplement|caffein + homoeriodictyol sodium salt|
16071510|NCT02372188|Dietary Supplement|homoeriodictyol sodium salt|
16071511|NCT02372175|Biological|Dengue-1 Virus-Live Virus Human Challenge (DENV-1-LVHC)|Dengue subtype 1 Challenge Virus (DENV-1) strain 45AZ5 administered as a single injection.
16071512|NCT02372162|Other|Image Fingerprint|This is an observational study that uses in depth diagnostic procedures to characterize patients with a comprehensive Image Fingerprint that includes CT, MRI and PET diagnostics
16071513|NCT02372162|Other|Molecular Fingerprint|This is an observational study that uses in depth diagnostic procedures to characterize patients with a Molecular Fingerprint that includes next-generation sequencing
16071514|NCT02372149|Drug|10% intravenous immunoglobulin (IVIg)|
16071515|NCT02372149|Drug|0.9% sodium chloride|
16071516|NCT02372136|Dietary Supplement|Individualized Nutrition|"Intake of macronutrients (protein, fat, and carbohydrate) will be individualized every day by adding one or more macronutrients to human milk based on daily measurements using near-infrared analysis.
~In patients receiving less milk than 140 ml x kg-1 x day-1 fortification of human milk will be adjusted to reach at least the average concentrations of protein, fat, and carbohydrate in donor's milk (Wojcik. J Am Diet Assoc. 2009 Jan;109:137-40) and 20 cal/oz as provided by the Mother's Milk Bank of North Texas.
~In those receiving at least 140 ml x kg-1 x day-1 of milk at 24 cal/oz fortification will be adjusted to meet recent guidelines from the the European Society of Paediatric Gastroenterology, Hepatology and Nutrition Committee on Nutrition (ESPGHAN) (Agostoni et al. J Pediatr Gastroenterol Nutr. 2010 Jan;50:85-91)."
16071517|NCT02372136|Dietary Supplement|Optimized nutrition|Milk fortification will be based on current recommendations and optimized by adjustment of nutrients once a week based on blood levels of urea nitrogen (corrected for serum creatinine level) and albumin and velocity of growth (weight and length).
16071518|NCT02372123|Other|lifestyle advice|Investigators will give lifestyle advice to patients such as exercising regularly, limiting caffeine, sugar and alcohol intake, reduction or cessation of smoking
16071520|NCT02372110|Drug|HPA, ANS stimulation|Oral administration of Hydrocortisone will increase HPA axis activity. Oral administration of Caffeine will boost ANS activity
16071521|NCT02372110|Drug|Placebo|Two cellulose placebo capsules filled with acidophilus powder will be administered to subjects who are randomly assigned to the placebo condition
16071522|NCT02372097|Drug|SYR-472|SYR-472 25mg, 50mg
16071523|NCT02372084|Drug|osilodrostat|
16071524|NCT02372071|Device|BiliCare|Two measurements with the BiliCare device
16071525|NCT02372058|Device|BiliCare|"Three non invasive measurements of TcB:
~Two measurements with the BiliCare device and one measurement with a competitive FDA approved device"
16071526|NCT02372032|Procedure|percutaneous lumbar discectomy|process percutaneous lumbar discectomy
16071527|NCT02372032|Procedure|ozone therapy|percutaneous intradiscal ozone injection
16071528|NCT02372019|Behavioral|CBM With Active Fear Reactivation|"Participants will undergo a fear reactivation trial, which involves giving a one-minute impromptu speech after only 30 seconds of preparation time. 10 minutes afterwards, they will be given CBM for interpretation bias. Training will involve 84 social scenario vignettes, with 70 resolving positively, 7 resolving negatively, and 7 resolving neutrally. This training takes places during the memory reconsolidation window that opens after fear reactivation, during which time the fear memory is in a labile state and thus more amenable to rewriting."
16071529|NCT02372019|Behavioral|CBM With Inert Fear Reactivation|"Participants will undergo a fear reactivation trial, which involves giving a one-minute impromptu speech after only 30 seconds of preparation time. 12 to 36 hours afterwards, they will be given CBM for interpretation bias. Training will involve 84 social scenario vignettes, with 70 resolving positively, 7 resolving negatively, and 7 resolving neutrally. Because this training takes places well outside of the memory reconsolidation window that opens shortly after fear reactivation, the reactivation is not expected to have any effect, and only serves as a control."
16071530|NCT02372019|Behavioral|Inert CBM With Inert Fear Reactivation|"Participants will undergo a fear reactivation trial, which involves giving a one-minute impromptu speech after only 30 seconds of preparation time. 12 to 36 hours afterwards, they will be given an inert form of CBM, which should not influence the direction of interpretation bias. Training will involve 84 social scenario vignettes, with 70 resolving neutrally, 7 resolving positively, and 7 resolving negatively. Because the CBM training takes places well outside of the memory reconsolidation window that opens after fear reactivation, the reactivation is not expected to have any effect, and the inert CBM training is not expected to have any effect either. This condition only serves as a control for the other two conditions."
16071531|NCT02372006|Drug|afatinib|
16071532|NCT02371993|Dietary Supplement|Choline|
16071533|NCT02371993|Other|Placebo|
16071534|NCT02371980|Drug|Vortioxetine|Vortioxetine capsules
16071535|NCT02371980|Drug|Placebo|Vortioxetine placebo-matching capsules
16071536|NCT02371967|Drug|Vismodegib|Vismodegib therapy will be given in compliance with the physician's standard practice as per local label.
16071537|NCT02371954|Behavioral|Happy Older Latinos are Active|Health promotion intervention desgined to prevent anxiety and depression in at risk older Hispanics
16071538|NCT02371954|Other|Fotonovela|Comic book style informational booklet designed for people with low literacy to educate them on mental illness.
16071539|NCT02371941|Drug|oral cromolyn sodium|Oral cromolyn sodium
16071540|NCT02371941|Drug|Placebo|Saline
16071541|NCT02371928|Other|Neuromuscular exercise program|"Exercises can be individually progressed from basic to elite level.
~Low load exercises are performed every day with 2 sets of 20-25 repetitions whereas high load exercises are performed three times per week with 2 sets of 8-12 repetitions.
~Exercises are progressed using the following components: arm-position, load, speed, open/closed eyes, stable/unstable surfaces.
~Patients have online access to instructions and video recordings of all exercises and progression levels. Patients are trained to continuously evaluate their own shoulder function and to adjust the exercise levels themselves at home.
~Supervision will be given two times a week for the first two weeks and then once a week for the remaining period."
16071542|NCT02371928|Other|Standard home exercise program|"Strengthening of the rotator cuff muscles are performed with the use of elastic bands (shoulder internal and external rotation besides abduction in scapular plane) whereas mobility/strengthening exercise for the scapular muscles are performed through weight-bearing positions and movements of the upper extremity.
~All exercises are performed three times a week with 2 sets of 10 repetitions."
16071543|NCT02371915|Other|Videoconference follow-up|Rheumatology visits to take place video videoconference with a physiotherapist present
16071544|NCT02371902|Device|MODULITH® SLK, STORZ MEDICAL AG, Switzerland|Three sessions were carried out, with the time interval between sessions spanning between 48 and 72 hours. In each session, 2400 pulses were administered with energy flux density (EDF) ranging from 0.14 and 0.20 mJ/mm2, depending on the maximum tolerated pain of each patient. Analgesics or local anaesthetics were not administered before, during or after treatment.
16071545|NCT02371902|Device|Cryoultrasound™, Medisport S.r.l., Italy|Cryo-US therapy was performed in a continuous emission modality, using an ultrasound emission power rating of 1,8 Watt/cm2, and a temperature of -2˚C, for a total of 12 sessions lasting 20 minutes each. The treatment was performed in 3 weeks (4 daily sessions per week).
16071546|NCT02371889|Drug|Topiramate|Max therapeutic dose of 200mg/day
16071547|NCT02371889|Behavioral|Medical Management|Medical Management (MM; Pettinati, 2004) will support subjects' efforts to reduce or stop their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The subject is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the subject's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 3 drinks 4 times per week; women will be advised to consume no more than 2 drinks 4 times per week.
16071548|NCT02371889|Drug|Inactive Placebo|In capsules indistinguishable from topiramate capsules and gradually increased to a maximum equivalent of 200 mg of topiramate/day
16071590|NCT02371590|Drug|Obinutuzumab|Obinutuzumab is administered as follows: Cycle 1: 100mg IV on day 1, 900 mg IV on day 2, 1000mg day 8, 1000 mg on day 15. Cycles 2-6: 1000mg IV on day 1.
16071549|NCT02371876|Device|ONYX PLUS Investigational Blood Glucose Monitoring System|Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood (and study staff tested subject fingerstick blood) using the ONYX PLUS Investigational Blood Glucose Monitoring System. All BG results were compared to reference method results obtained from subject capillary blood. Study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma.
16071550|NCT02371850|Drug|Nicoderm patch first, then Aveva patch|This is a single group assignment where each of 10 adult smokers completes 4 procedure days using a Nicoderm CQ nicotine patch (2 days) followed by the application of a generic Aveva patch (2 days). For each patch, heating is applied for one hour at hour 4 on the first procedure day and at hour 8 in the second procedure day (2 days per patch, or a total of 4 days per subject).
16071551|NCT02371837|Other|Pilates and fall prevention|A 2 days per week during 6 week Pilates practice will be performed in experimental group in order to check the effectiveness in fall prevention
16071552|NCT02371824|Other|MRI sequence|One supplementary MRI sequence Dynamic Contrast Enhancement (DCE) was added to the clinical protocol.
16071553|NCT02371811|Device|uterine manipulator (v care)|
16071554|NCT02371798|Drug|Gadopentetate dimeglumine|IV administration of 0.2 mmol/kg of Gd-DTPA
16071555|NCT02371785|Device|CorPath 200 System|Remote delivery of guide wires and balloon catheters for use in percutaneous vascular interventions (PVI).
16071556|NCT02371772|Other|Training|Patients were trained to monitor INR and dose warfarin
16071557|NCT02371759|Drug|L+C maxillary anesthesia|Maxillary anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
16071558|NCT02371759|Drug|L+C mandibular anesthesia|Mandibular anesthesia obtained by 2% lidocaine + clonidine (15 mcg/ml)
16071559|NCT02371759|Drug|L+E maxillary anesthesia|Maxillary anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
16071560|NCT02371759|Drug|L+E mandibular anesthesia|Mandibular anesthesia obtained by 2% lidocaine + epinephrine (1:80 000)
16071561|NCT02371746|Drug|ENV515-3 Travoprost XR|
16071562|NCT02371746|Drug|ENV515-1 Travoprost XR|
16071563|NCT02371746|Drug|ENV515-3-2 Travoprost XR|
16071564|NCT02371733|Other|Upper extremity aerobic exercise training|"Training group will receive upper extremity aerobic exercise training using arm ergometer at 50-80% of maximal heart rate and breathing exercises.
~Training will exercise with arm ergometer 3days/week, for 6 weeks with the assistance of a physiotherapist. Training workload will be undercontrol both using target heart rate and Modified Borg dyspnea scale. Training group will also perform breathing exercises 120 times/day, 7 days/week, for 6 weeks."
16071565|NCT02371733|Other|Alternative upper extremity exercises|"Control group will receive alternative upper extremity exercises and breathing exercises. Control group will perform alternative upper extremity exercises 3days/week, for 6 weeks and also breathing exercises 120 times/day, 7 days/week, for 6 weeks.
~Control group will be followed-up by telephone once a week."
16071566|NCT02371720|Behavioral|Mobile DOT|Daily reminders via text or email to send a video of themselves taking their Hydroxyurea, positive feedback, and be encouraged to contact the research coordinator with any questions, concerns, etc.
16071567|NCT02371707|Drug|Idalopirdine 60 mg formulation A (test)|Tablet for oral use, single dose
16071568|NCT02371707|Drug|Idalopirdine 60 mg formulation B (reference)|Tablet for oral use, single dose
16071569|NCT02371694|Other|Test drink|"The intervention is a drink taken 4 hours after the evening meal insulin injection, or 10PM, whichever is later. All drinks are 116-120g in weight and similar volume.
~All drinks are served in a double blind fashion, apart from the 20g carbohydrate which is visibly different from other drinks in colour, texture and flavour."
16071573|NCT02371668|Biological|CR6261|50 mg/kg administered as a single 2-hour intravenous infusion on Day 1 (24 hours after virus administration).
16071574|NCT02371668|Biological|Placebo|Administered as a single 2-hour intravenous infusion on Day 1 (24 hours after virus administration).
16071575|NCT02371655|Procedure|Diet|A low-fibre diet for three days before the examination
16071576|NCT02371655|Drug|Faecal Tagging|Oral ingestion of iodinated contrast media (Gastrografin 60 ml) 3h before the examination
16071577|NCT02371655|Drug|Bowel cleansing|Oral ingestion of water solution (macrogol 100 mg, Sanipeg) the day before the examination
16071578|NCT02371655|Procedure|CT colonography|CT Examination of the colon aimed to detect polyps and cancer
16071579|NCT02371629|Drug|NVA237|NVA237 capsules for inhalation, delivered via a Single Dose Dry Powder Inhaler (SDDPI) called Concept1
16071580|NCT02371629|Drug|Placebo|Placebo to NVA237
16071581|NCT02371629|Drug|Salbutamol|All patients received salbutamol (100 μg) as only rescue medication
16071582|NCT02371616|Device|Calcium sodium phosphosilicate|5% w/w calcium sodium phosphosilicate
16071583|NCT02371616|Other|Sodium fluoride|1426 ppm fluoride as sodium fluoride
16071584|NCT02371616|Other|Sodium monofluorophosphate|1426 ppm fluoride as sodium monofluorophosphate
16071585|NCT02371603|Drug|GSK1278863 25 mg Tablet|A round, biconvex, white film coated tablet to be taken orally in the fasted state in the morning
16071586|NCT02371603|Drug|Pioglitazone 15 mg Tablet|"White to off-white, round, convex, non scored tablet with ACTOS on one side, and 15 on the other, to be taken orally in the fasted state in the morning"
16071587|NCT02371603|Drug|Rosuvastatin 10 mg Tablet|"Pink, round, biconvex, coated tablets. Debossed CRESTOR and 10 on one side, to be taken orally in the fasted state in the morning"
16071588|NCT02371603|Drug|Trimethoprim 100 mg Tablet|"White, round, scored, convex tablet, debossed 93 above the score and debossed 2159 below the score on one side and plain on the other, to be taken orally as two tablets once in the morning and once in the evening"
16071589|NCT02371590|Drug|Lenalidomide|"Lenalidomide is administered orally once daily on Days 8-28 of each 28 day cycle. The starting dose for all patients is 5 mg PO daily. At the start of each cycle, there is intra-patient dose-escalation to a maximum of 25mg daily, as tolerated.
~The study consists of a 6 month treatment period with obinutuzumab and lenalidomide, and an indefinite period of treatment with lenalidomide for as long as it is helpful and tolerated by subject."
16071770|NCT02370277|Other|Laboratory Biomarker Analysis|Correlative studies
16071591|NCT02371577|Drug|Lenalidomide|Lenalidomide is administered orally once daily on Days 8-28 of each 28 day cycle. The typical starting dose is 2.5mg PO daily. At the start of each cycle, there is intra-patient dose-escalation to a maximum of 25mg daily, in the absence of grade 2 or higher adverse events Duration of lenalidomide on the clinical trial is for up to 6 cycles, each of 28 day duration.
16071592|NCT02371564|Device|High flow humidified oxygen|
16071593|NCT02371564|Device|Standard flow humidified oxygen|
16071594|NCT02371551|Other|Blood/urine sampling|Routine chemistry profile
16071595|NCT02371551|Other|Conventional routine CT examination|Standard diagnostic examination
16071596|NCT02371551|Other|Contrast-enhanced renal ultrasonography (CEUS)|Study-specific diagnostic examination
16071597|NCT02371551|Other|Functional MRI|Study-specific diagnostic examination
16071598|NCT02371538|Dietary Supplement|Donor Breastmilk|Donor breastmilk will be obtained from the Mother's Milk Bank of New England.
16071599|NCT02371525|Behavioral|Prepmate|A novel multi-modal, technology-based intervention for pre-exposure prophylaxis (PrEP) adherence support .
16071600|NCT02371512|Device|MitraClip system (Abbott Vascular, Menlo Park, USA)|Valve repair with the MitraClip system (Abbott Vascular, Menlo Park, USA) consists of a steerable guide through which a Clip Delivery System is advanced to the left atrium.
16071601|NCT02371512|Procedure|Mitral valve surgery|Mitral valve surgery or mitral valve replacement (technique and access at the discretion of the participating surgical center, MACE procedure and tricuspid annuloplasty possible)
16071602|NCT02371499|Dietary Supplement|Lactobacillus casei DG|the patients will receive 1 capsule of Lactobacillus casei DG (Enterolactis plus®) twice daily for 4 weeks
16071603|NCT02371499|Dietary Supplement|Placebo|the patients will receive 1 capsule of product without bacteria (Enterolactis placebo) twice daily for 4 weeks
16071604|NCT02371486|Procedure|hysteroscopic repair of cesarean section defect|Operative hysteroscopy for the repair of cesarean section defect is performed under general anesthesia. the cervix is dilated and the cesarean section defect opened. polypoid tissue is ablated
16071605|NCT02371486|Procedure|Diagnostic Hysteroscopy|Betthochi's method for diagnostic hysteroscopy: No anesthesia will be used. vaginoscopy will be performed, followed by diagnostic hysteroscopy. saline will be used as a distension media. 4.2 mm Storz hysteroscope will be used.
16071606|NCT02371486|Procedure|Ultrasound Scan|"Scanning the uterus with the ultrasound probe . Transvaginal ultrasound usually produces better and clearer images of the female pelvic organs, because the ultrasound probe lies closer to these structures.
~The transvaginal ultrasound probe is thin, about 2cm diameter. The probe is covered with a disposable protective sheath. A small amount of ultrasound gel is placed on the end of this probe. The probe is then gently inserted a short distance into the vagina."
16071607|NCT02371486|Procedure|IVF Cycle|Controlled ovarian hyperstimulation, followed by Human chorionic Gonadotropin ( hCG) administration, Ovum Pickup and Embryo transfer
16071608|NCT02371473|Drug|Acetazolamide-placebo|The patients in this arm are given Acetazolamide mg for six days and after 2 weeks washout they are given placebo for six days.
16071609|NCT02371473|Drug|Placebo-acetazolamide|The patients in this arm are given placebo for six days and after 2 weeks washout they are given Acetazolamide for six days.
16071610|NCT02371460|Dietary Supplement|DHA-rich algal oil|Mothers will receive a DHA-rich algal oil treatment (400 mg DHA per capsule) three times a day before meals from randomization (<72 hours post-delivery) until the infant reaches 36 weeks PMA.
16071611|NCT02371460|Dietary Supplement|Placebo|Mothers will receive a placebo capsule three times a day before meals from randomization (<72 hours post-delivery) until the infant reaches 36 weeks PMA.
16071612|NCT02371447|Drug|VPM1002BC|"Phase 1:
~Induction: 6 intravesical instillations of VPM1002BC in 6-12 weeks (dose de-escalation in cohorts of 3-6 patients)
~Phase 2:
~Induction: VPM1002BC at RP2D established in phase I, 6 intravesical instillations in 6-12 weeks (n=39 including patients treated at RPD2 in phase I)"
16071613|NCT02371434|Biological|autologous CD4+CD25+FoxP3+ natural regulat. T cells (nTregs)|autologous CD4+CD25+FoxP3+ natural regulatory T cells (nTregs). nTregs will be infused at escalating doses of 0.5 x 10^6, 1 x 10^6, and 2.5-3 x 10^6 cells/kg body weight in cohorts of three patients each.
16071614|NCT02371421|Drug|Allopurinol|
16071615|NCT02371408|Drug|ravidasvir hydrochloride|200 mg
16071616|NCT02371408|Drug|sofosbuvir|400 mg
16071617|NCT02371408|Drug|ribavirin|1000 mg - 1200 mg per day, weight-based dosing
16071618|NCT02371395|Other|Realtime amplification (RealAmp)|Molecular assay for the diagnosis of malaria.
16071619|NCT02371382|Device|Arthroplasty hip|Hip replacement
16071620|NCT02371369|Drug|Pexidartinib|Each capsule contains 200 mg of pexidartinib for oral administration
16071621|NCT02371369|Drug|Placebo|Placebo capsule matching pexidartinib capsule for oral administration
16071622|NCT02371343|Dietary Supplement|Fish oil, Ocean plus|Ocean Plus, 1200 mg, EPA 384 mg DHA 252 mg, total omega-3 782 mg, 50 soft gel, Ocean®, Germany
16071623|NCT02371343|Dietary Supplement|Sunflower Oil|
16071624|NCT02371317|Behavioral|Mindfulness-Based Stress Reduction|Patients are randomized to an intervention
16071625|NCT02371317|Behavioral|Stress Management Education|Patients are randomized to an intervention
16071626|NCT02371317|Other|American Heart Association Recommended Self-Care|All Patients receive AHA Recommended Self-Care
16071627|NCT02371304|Radiation|Adjuvant chemoradiotherapy|Patients will receive capecitabine 825 mg/m2 twice a day for 5 weeks only on weekdays. This will be combined with 1.8 Gy in 25 fractions with a limited dose only on the mesorectum
16071628|NCT02371304|Procedure|Additional TME surgery|
16071629|NCT02371304|Drug|capecitabine|
16071630|NCT02371291|Behavioral|Memory Flexibility Training|As in experimental arm description.
16071631|NCT02371291|Behavioral|Psychoeducation|As in experimental arm description.
16071632|NCT02371278|Dietary Supplement|Leucine|5 g leucine with sucrose and maltodextrin
16071633|NCT02371278|Dietary Supplement|Placebo|5 g glycine with sucrose and maltodextrin
16071727|NCT02370576|Other|rating scale application|"Administration of validated PTSD, MDD and anxiety disorders rating scales immediately after birth and 1 month postpartum.
~rating scale application"
16071634|NCT02371265|Other|Adherence and retention package|"Based on formative research findings, the following core components of the B+ study intervention have been designed and will be stepped in at the study sites to improve early retention in care and adherence:
~Workflow modification: 1) Redefinition of key roles of MCH nurses and task shifting to community health workers (CHW's), and 2) enhanced patient tracking via improved management of registries/charts;
~Adherence and retention package: 1) Creation of Adherence Committees at each site to coordinate and systematize patient follow-up, 2) active patient follow-up and home visits by community health workers (CHWs or activistas), 3) use of text messaging to patients by MCH nurses, 4) improved and intensified counseling coordinated with active CHW and text follow-up, and 5) intensified and improved Option B+ training and supportive supervision."
16071635|NCT02371252|Drug|Generic alendronate|The patients will be given the generic alendronate 1 tablet per week for approximately 1 year after enrollment.
16071636|NCT02371239|Behavioral|Physical activity intervention|
16071637|NCT02371226|Drug|AGT-181 (HIRMAb-IDUA)|intravenous infusion over 3-4 hours
16071638|NCT02371213|Other|social networking on mobile phone|Audio-video media about serious complications such as labor pain, vaginal bleeding, water breaking and fewer fetal movement via social networking application on mobile phone to antenatal women from the first ANC visit four times every month and four times biweekly
16071639|NCT02371200|Device|Brain Sentinel Seizure Detection and Warning System|The detection device is worn on the bicep brachii muscles and is intended to alert a remote caregiver of a GTC seizure and provide a record of GTC seizure activity.
16071640|NCT02371187|Drug|Dapagliflozin|Dapagliflozin tablets, 5 mg, one per day for the first 14 days, increase to two per day for 70 days.
16071641|NCT02371187|Drug|Placebo|Matching placebo for Dapagliflozin 5 mg, one per day for the first 14 days, increase to two per day for 70 days.
16071642|NCT02371161|Drug|R-DHAP/R-ICE|"R-DHAP/R-ICE 3 cycles every 21 days:
~R-DHAP
~Rituximab 375 mg/m2, e.v. day 1
~Desamethasone 40 mg days 1-4
~cis-Platino100 mg/m2, day 2 (if ≥70 years 75 mg/m2)
~Aracytin 2000 mg/m2, e.v. day 3 (if ≥70 years 1500 mg/m2)
~R-ICE
~Rituximab 375 mg/m2, e.v. day 1
~Etoposide 100 mg/mq, e.v. days 1,2,3 (if ≥70 years 75 mg/mq)
~Ifosfamide with Mesna equidone 5000 mg/mq, day 2 (if ≥70 years 3750 mg/mq)
~Carboplatino AUC=5, e.v. (max 800 mg/mq), day 2 (if ≥70 years AUC=4)
~Conditioning BEAM or FEAM"
16071643|NCT02371148|Drug|Bortezomib-Rituximab-Bendamustine|"Bortezomib-Rituximab-Bendamustine Bortezomib: 1.3 mg/mq sc days 1, 8, 15, 22* Rituximab: 375 mg/sqm i.v. day 1** Bendamustine: 90 mg/sqm iv days 1-2 or days 2-3 according to institutional/physician choice Repeat cycles every 28 days for a total of 6 cycles *In case of toxicity is omitted
~**In cycles 1, in order to avoid tumor lysis syndrome, Rituximab will be given on day 8"
16071644|NCT02371135|Genetic|colonic biopsies|
16071645|NCT02371135|Genetic|questionnaires|
16071646|NCT02371122|Device|Therapy Setting 1 (Medtronic)|RestoreSensor or RestoreUltra Setting 1
16071647|NCT02371122|Device|Therapy Setting 2 (Medtronic)|Medtronic RestoreSensor or RestoreUltra Setting 2
16071648|NCT02371122|Device|Therapy Setting 3 (Medtronic)|Medtronic RestoreSensor or RestoreUltra Setting 3
16071649|NCT02371122|Device|Therapy Setting 4 (Medtronic)|Medtronic RestoreSensor or RestoreUltra Setting 4
16071650|NCT02371109|Other|selftaken versus clinically taken swabs|
16071651|NCT02371096|Drug|MabThera (rituximab)|
16071652|NCT02371096|Drug|RGB-03|
16071653|NCT02371083|Other|Extended timing of pessary care|
16071654|NCT02371031|Drug|6-[F-18]-Fluoro-L-3,4,-dihydroxyphenylalanine|
16071655|NCT02371031|Device|PET/MRI|
16071656|NCT02371031|Procedure|Surgical resection (standard of care)|
16071657|NCT02371018|Dietary Supplement|Nepro|Patients will be asked to consume a single 8 oz can of Nepro
16071658|NCT02371005|Radiation|Cone Beam Computed Tomography (CBCT)|
16071659|NCT02370992|Radiation|I125 brachytherapy|I125 brachytherapy is a standard treatment and will be delivered using routine techniques involving a preimplant volume study followed by implantation of the I125 sources. This is undertaken as an inpatient or day case under general or spinal anaesthetic according to local practice
16071660|NCT02370979|Biological|Blood samples|
16071661|NCT02370966|Dietary Supplement|Berry powder|Berry and gingivitis trial
16071662|NCT02370953|Device|VERION for toric IOL alignment|The VERION Measurement Module is a diagnostic device which can make high resolution colour reference images of the patient's eye for position reference. The VERION Digital Marker is a medical device that assists the surgeon in planning and performing surgical procedures on the eye. The VERION tools use several reference points on the conjunctiva and limbus, and make an overlay between the preoperative achieved and live-surgery image. During surgery, this device projects the horizontal axis and the estimated placement axis of the toric IOL on the patient's eye, and therefore, the surgeon can accurately place the toric IOL to its preoperatively calculated angle.
16071663|NCT02370953|Procedure|Conventional, manual ink-marking for toric IOL alignment|Several manually performed methods are used to align the toric IOL at the intended axis. Most of them use a 3-step procedure. First, the horizontal axis of the eye is temporarily marked with ink in a seated position to correct for cyclotorsion when changing into supine position. Three spots on the conjunctiva, close to the edge of the cornea, are applied at 0°, 90° and 180°, which may be done by using a bubblemarker or gravity marker with a calibrated horizontal position. Next, the desired alignment axis for the toric IOL is marked intra-operatively. The last step is to rotate the implanted toric IOL until the IOL markings agree with the alignment marks. After surgery is performed, the ink marks will disappear within a few hours.
16071664|NCT02370940|Other|High phytate intake|
16071665|NCT02370940|Other|Low phytate intake|
16071666|NCT02370927|Other|Control|Non pulse extruded cereal
16071667|NCT02370927|Other|Pea protein|Pulse extruded cereal
16071668|NCT02370927|Other|Pea Starch|Pulse extruded cereal
16071669|NCT02370927|Other|Pea fibre + pea starch|Pulse extruded cereal
16071670|NCT02370927|Other|Pea protein + pea starch|Pulse extruded cereal
16071671|NCT02370927|Other|Pea fibre + pea starch + pea protein|Pulse extruded cereal
16071672|NCT02370914|Device|Nautilus NeuroWaveTM System|Recording of subjects with Nautilus NeuroWave diagnostic device
16071673|NCT02370914|Behavioral|SCAT|A Neurocognitive evaluation of the patients to assess for concussion.
16071725|NCT02370589|Biological|Placebo|
16071676|NCT02370888|Drug|Lenalidomide|Subjects will be enrolled in cohorts of three (3). Lenalidomide will be administered for 21 consecutive days in a 28 day cycle X 2 cycles. The starting dose will be 2.5 mg given orally every other day for 21 days.
16071677|NCT02370875|Device|Magstim RapidStim2|Application of repetitious transcranial magnetic stimulation (TMS) pulses using Magstim RapidStim2 to a specific brain target at predefined stimulation parameters.
16071678|NCT02370875|Device|Sham Magstim RapidStim2|Same procedure as real rTMS without stimulating the cerebral cortex.
16071679|NCT02370862|Drug|Neostigmine and Glycopyrrolate|
16071680|NCT02370849|Drug|nimotuzumab|nimotuzumab 200mg infusion on day 1,8,15 every 3 weeks
16071681|NCT02370849|Drug|cisplatin|cisplatin: 30 mg/m2 iv. infusion on day 1, 2 every 3 weeks
16071682|NCT02370849|Drug|S-1|S-1: 40 mg/m2 bid , 2 weeks on, 1 week off ；
16071683|NCT02370836|Other|Education|One 60 minute psycho-oncological educational session on stress management, late effects and fatigue.
16071684|NCT02370823|Procedure|Regenexx SD|stem cell treatment
16071685|NCT02370810|Behavioral|CBT-based internet-intervention for tinnitus|The intervention offered is a CTB-based internet intervention, providing an opportunity to learn about new ways of coping with tinnitus during everyday life. It is 8 week long e-learning intervention, with new modules introduced weekly and assignments given to practice techniques learnt.
16071686|NCT02370797|Radiation|Single Fraction IOeRT|A single dose of 21 Gy calculated such that the 90% isodose line encompasses the posterior of the tumor bed will be administered.
16071687|NCT02370784|Drug|atorvastatin|Atorvastatin is an oral cholesterol-lowering medication commonly referred to as statin therapy.
16071688|NCT02370784|Drug|Placebo|oral drug of similar appearance to atorvastatin
16071689|NCT02370771|Procedure|Biological sampling|Biological sampling to identify by label-free proteomic analysis of a combination of serum biomarkers in patients with Erosive and non erosive hand Osteoarthritis
16071690|NCT02370771|Device|Radiographic evaluation|Radiographic assessments using Bone Mineral Analyser and Hand MRI will be done in patients with Erosive and non erosive hand Osteoarthritis
16071691|NCT02370758|Drug|Valganciclovir or Ganciclovir|
16071692|NCT02370745|Drug|GLP-1|GLP-1 effects on skeletal muscle glucose and amino acid metabolism and microvascular blood flow will be scrutinised under the specified insulin concentrations. It will also be used to test the effect of intravenous feed on insulin secretion.
16071693|NCT02370745|Drug|Insulin Actrapid|Skeletal muscle metabolic and microvascular parameters will be tested under specified insulin concentrations with or without GLP-1
16071694|NCT02370745|Dietary Supplement|Oral amino acids|Oral amino acids containing 15 g of amino acids
16071695|NCT02370745|Drug|GIP|This will be co infused with GLP-1 and intravenous amino acids
16071696|NCT02370745|Drug|Intravenous amino acids|This will aim to deliver iso equivalent amount to the amino acids administered orally
16071697|NCT02370732|Other|Alcohol|A weight based dose of alcohol will be administered during each study day.
16071698|NCT02370719|Behavioral|Mobile application for diabetes self-management|
16071699|NCT02370706|Drug|PIM447|pan-pim inhibitor
16071700|NCT02370706|Drug|Ruxolitinib|JAK1/JAK2 inhibitor
16071701|NCT02370706|Drug|LEE011|CDK4/6 inhibitor
16071702|NCT02370693|Drug|Bortezomib|Bortezomib 1.3 mg/m² subcutaneously (or IV push if unable to tolerate subcutaneous injection) once per week for the first two weeks per month for 24 weeks
16071703|NCT02370693|Drug|Placebo|Placebo (normal saline) 1.3 mg/m² subcutaneously (or IV push if unable to tolerate subcutaneous injection) once per week for the first two weeks per month for 24 weeks
16071704|NCT02370693|Drug|Mycophenolate mofetil|Mycophenolate mofetil 1.5 g twice a day orally for 24 weeks
16071705|NCT02370680|Drug|Aspirin|steady-state run-in prior to Durlaza treatment
16071706|NCT02370680|Drug|Durlaza™|comparison of different numbers of capsules
16071707|NCT02370667|Other|Biomechanical Exercise (BE)|A biomechanical exercise program shown to decrease joint loading will be administered 3 times a week for 12 weeks. Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis.
16071708|NCT02370667|Other|Traditional Exercise (TE)|A traditional exercise program for people with knee OA will be administered 3 times a week for 12 weeks. Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis.
16071709|NCT02370667|Other|Meditation Control (M)|A meditation program acting as a control will be administered 3 times a week for 12 weeks. Outcomes will include mobility performance; pain; muscle and fat volumes, and cartilage morphology using MRI; strength; cardiovascular fitness; and gait analysis.
16071710|NCT02370654|Behavioral|Tai chi|
16071711|NCT02370654|Behavioral|Conventional exercise|
16071712|NCT02370641|Dietary Supplement|PomX|1000 mg POMx daily for 4 weeks
16071713|NCT02370628|Procedure|Percutaneous vertebroplasty|"The procedure involves percutaneous application of bone cement (polymethylmethacrylate) into collapsed vertebrae, and has been used for treatment of patients with osteoporosis who have severe or prolonged pain following vertebral compression fracture, as well as those with painful, aggressive hemangiomas and osteolytic neoplasms.
~In our trial, vertebroplasty shall be performed in two steps:
~Step 1: facet block
~Step 2: cement infusion
~Therefore, patients in both arms will undergo Step 1 since our control intervention serves as a routine first part of our active intervention."
16071714|NCT02370628|Procedure|Facet block|"A long-acting local anesthetic agent and corticosteroids are injected in the spinal articular facets at the affected level.
~All patients will undergo facet block since it serves as a routine first part to percutaneous vertebroplasty."
16071715|NCT02370615|Drug|TAK-272|TAK-272 tablet.
16071716|NCT02370615|Drug|Digoxin|Digoxin tablet.
16071717|NCT02370615|Drug|Itraconazole|Itraconazole oral solution
16071718|NCT02370615|Drug|Midazolam|Midazolam syrup.
16071719|NCT02370602|Drug|TAK-063|TAK-063 tablets
16071720|NCT02370602|Drug|[^11C]T-773|[^11C]T-773 IV solution
16071721|NCT02370589|Biological|Base Dose EBOV GP Vaccine|
16071722|NCT02370589|Biological|2x Base Dose EBOV GP Vaccine|
16071723|NCT02370589|Biological|4x Base Dose EBOV GP Vaccine|
16071724|NCT02370589|Biological|8x Base Dose EBOV GP Vaccine|
16071728|NCT02370563|Drug|18F-FSPG|18F-FSPG is a novel F18-labelled, radiopharmaceutical agent for PET imaging. It is administered intravenously at a dose of 300 MBq (8.1mCi ± 10%).
16071729|NCT02370550|Drug|Cyclosporin A|CsA 2-3 mg/kg/d, BID PO
16071730|NCT02370550|Drug|Prednisone|Prednisone 0.5mg/kg/d QD PO starting at Week 0. After 2-4 weeks, the initial dose is gradually tapered by 2.5 mg each week until a maintenance dosage of 5-7.5 mg/d through week 52 (visit 6). The initial and maintenance doses are determined by the investigators of each center depending on the patients.
16071731|NCT02370550|Drug|Placebo|Placebo tablet 2-3 mg/kg/d, BID PO
16071732|NCT02370550|Drug|Calcium carbonate D|Calcium carbonate D 600 mg, QD PO
16071733|NCT02370537|Drug|Epanova® (omega-3 carboxylic acids)|4 g (administered orally as 4 x 1 g capsules)
16071734|NCT02370537|Drug|Omacor® (omega-3-acid ethyl esters)|4 g (administered orally as 4 x 1 g capsules)
16071735|NCT02370524|Drug|[18F]T807|All enrolled subjects will undergo an [18F]T807 PET imaging visit. In addition, subjects with AD and aged volunteers will have one PET scan with Amyvid (florbetapir F 18 injection) as part of the screening activities to measure Aβ in the brain.
16071736|NCT02370511|Device|Transcatheter Mitral Valve Replacement|Implantation of a balloon expandable Edwards SAPIEN XT or SAPIEN 3 transcatheter heart valve in the mitral position.
16071737|NCT02370498|Biological|pembroliziumab|200 mg administered as IV infusion on Day 1 of each 21-day cycle.
16071738|NCT02370498|Drug|paclitaxel|80 mg/m^2 administered as IV infusion on Days 1, 8, and 15 of each 28-day cycle.
16071739|NCT02370485|Drug|LY2801653|Administered orally
16071740|NCT02370472|Other|tool developed using cameras and a computer|cameras allowing subject to be able to visualize hand and needle movements as well s the position of the transducers along with the image from the ultrasound on a computer screen
16071741|NCT02370459|Other|AFIX in-person consultation|The adolescent AFIX (Assessment, Feedback, Incentives, and eXchange) Program is a quality improvement strategy developed by the CDC to improve the immunization practices and vaccination coverage levels of public and private health care providers. It has four main components: 1) Assessment of a provider's current immunization practices and vaccination levels, 2) Feedback of the assessment results and strategies to improve coverage levels, 3) Incentives to improve coverage levels, and 4) eXchange of information and resources necessary to facilitate improvement. Relevant AFIX information will be communicated to vaccine providers using several intervention and quality improvement components.
16071742|NCT02370459|Other|AFIX webinar consultation|The adolescent AFIX (Assessment, Feedback, Incentives, and eXchange) Program is a quality improvement strategy developed by the CDC to improve the immunization practices and vaccination coverage levels of public and private health care providers. It has four main components: 1) Assessment of a provider's current immunization practices and vaccination levels, 2) Feedback of the assessment results and strategies to improve coverage levels, 3) Incentives to improve coverage levels, and 4) eXchange of information and resources necessary to facilitate improvement. Relevant AFIX information will be communicated to vaccine providers using several intervention and quality improvement components.
16071743|NCT02370446|Other|personalized medication log|
16071744|NCT02370446|Other|standard of care|
16071745|NCT02370446|Behavioral|questionnaires|
16071746|NCT02370446|Behavioral|Cognitive Interview|
16071747|NCT02370433|Drug|Intravenous Neostigmine and Glycopyrrolate|
16071748|NCT02370433|Drug|Transdermal Neostigmine and Glycopyrrolate|
16071749|NCT02370420|Biological|Platelet-Rich Plasma|Autologous Platelet-Rich Plasma will be applied by a intra-articular injections
16071750|NCT02370420|Behavioral|rehabilitation exercises|Patients would been shown rehabilitation exercises, to perform them at home
16071751|NCT02370407|Device|a laparoscopic simulator (Fundamentals of Laparoscopic Surgery (FLS), VT Medical Inc, Waltham, MA)|10 repetitions of practice on laparoscopic simulator.
16071752|NCT02370407|Device|Mimic da Vinci robotic simulator|10 repetitions of practice on Mimic da Vinci robotic simulator.
16071753|NCT02370394|Behavioral|ROSE Program|The ROSE Program was specifically tailored, innovative and relevant to diverse, racial and ethnic perinatal women in a number of ways including the images and content used in the intervention and coordinating study appointments with treatment visits. It was tailored to the current IPV risk assessment, pregnancy or postpartum status of each participant, was designed to reach participants across levels of motivation for change. The content of ROSE was theory-driven, consistent with the Motivational Interviewing model of behavior, and consistent with the literature on effective interventions that address IPV.
16071754|NCT02370368|Device|XBOX Kinect Just Dance 2014|The XBOX Kinect Just dance 2014 is videogame based interactive dance programme designed to encourage activity while gaming.
16071755|NCT02370368|Other|Agility Ladder Drills|Types of ladder drill exercises including single leg hop right and left leg, bunny hop, slalom jumps, bunny twist, lateral runs right and left, high knees with forward progression, backward run, bunny hop backward, single leg lateral hops, lateral bunny hops and snake carrioca moguls.
16071756|NCT02370355|Other|Cytology Specimen Collection Procedure|Undergo collection of blood samples
16071757|NCT02370355|Other|Laboratory Biomarker Analysis|Correlative studies
16071758|NCT02370342|Procedure|Robot-Assisted Laparoscopic Surgery|Undergo robot-assisted laparoscopic HIFU ablation
16071759|NCT02370342|Procedure|High-Intensity Focused Ultrasound Ablation|Undergo robot-assisted laparoscopic HIFU ablation
16071760|NCT02370342|Procedure|Therapeutic Laparoscopic Surgery|Undergo laparoscopic partial nephrectomy
16071761|NCT02370342|Device|Sonatherm 600i Ultrasonic Lesion Generating System|Device used for high-intensity focused ultrasound ablation
16071762|NCT02370329|Other|Laboratory Biomarker Analysis|Correlative studies
16071763|NCT02370329|Other|Quality-of-Life Assessment|Ancillary studies
16071764|NCT02370329|Biological|Ropeginterferon Alfa-2B|Given SC
16071765|NCT02370316|Behavioral|Metacognitive Interpersonal Therapy (MIT-SA)|MIT-SA consists of weekly individual therapy (1 year) and weekly group sessions (six months)
16071766|NCT02370316|Behavioral|Clinical Structured Treatment|structured case management and symptom-targeted medication
16071767|NCT02370290|Other|Medical Chart Review|Clinical and imaging information collected
16071768|NCT02370290|Other|Informational Intervention|Clinical and imaging data collected
16071769|NCT02370277|Other|Cytology Specimen Collection Procedure|Undergo collection of stool samples
16071771|NCT02370277|Other|Questionnaire Administration|Ancillary studies
16071772|NCT02370264|Procedure|Quality-of-Life Assessment|Ancillary studies
16071773|NCT02370264|Other|Questionnaire Administration|Ancillary studies
16071774|NCT02370264|Other|Medical Chart Review|Ancillary studies
16071775|NCT02370251|Drug|Omegaven|Once the direct bilirubin is 2 mg/dL or more x 2 weeks, Intralipid will be switched to Omegaven at 1 g/kg/day. The bilirubin level will be monitored to determine when resolution of cholestasis (DB <2 mg/dL) occurs.
16071776|NCT02370238|Drug|paclitaxel|paclitaxel 80 mg/m2 i.v. (Days 1, 8, and 15)
16071777|NCT02370238|Drug|Reparixin|reparixin oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle
16071778|NCT02370238|Drug|placebo|placebo oral tablets 1200 mg t.i.d. continuing from D 1 to Day 21 of 28-day cycle
16071779|NCT02370225|Other|aerobic exercise|"Each training session was preceded by a warm-up period, where patients were instructed to walk freely and slowly for 5 minutes, followed by 20 to 50 minutes of effective walking when they were instructed to maintain their paces to achieve the target heart rate and ending by a cold-up period for 5 minutes (similar to warm-up period).
~The exercise prescription was based on the heart rate at the anaerobic threshold determined at the initial assessment. The increment of intensity exercise was based on time: 30 in the first 2 weeks, adding 5 minutes per week until eighth week, completing 60 minutes, which remains until the end."
16071780|NCT02370212|Dietary Supplement|Creatine|
16071781|NCT02370212|Dietary Supplement|Placebo|
16071782|NCT02370212|Other|High intensity interval training|
16071783|NCT02370199|Device|670 nm light|670 nm light emitting diode will be placed 1 cm above the gastrocnemius muscle. The diode will not be in direct contact with the skin. Subjects will be exposed to 75 mW/cm2.
16071784|NCT02370199|Drug|octafluropropane|Octofluoropropane will be administered as a continuous infusion prior to the initiation of 670 nm light in order to measure skeletal muscle blood flow.
16071785|NCT02370173|Device|PTSD wavelength-1 bright light|6 weeks of daily light exposure, 30 minutes per morning.
16071786|NCT02370173|Device|PTSD wavelength-2 bright light|6 weeks daily light exposure, 30 minutes per morning.
16071787|NCT02370160|Biological|DT2219ARL|DT2219ARL at assigned dose IV on day 1, 3, 5, 8 and day 15, 17, 19, and 22. Up to 2 additional courses of DT2219ARL may be given until disease progression and/or unacceptable toxicity.
16071788|NCT02370147|Behavioral|Smoking reduction intervention|Smokers was informed that many harmful effects were proved to be related with smoking, such as cancer, coronary heart disease, respiratory disease and many other health problems, and one out of two smokers will be killed by smoking. Smokers will be advised to reduce smoking consumption for at least half of their total consumption in the next month. Finally, all smokers were warned to keep in mind that the current attempt to reduce smoking is an intermediate step before the complete cessation.
16071789|NCT02370147|Behavioral|Exercise and diet advice control|Smokers will be asked to do regular activities for three or four times per week, and to have a healthy and balanced diet, having more fruit and vegetables which are rich in vitamins, high in nutrition yet low in calories. In the whole process, advises will not refer to smoking cessation or smoking reduction.
16071790|NCT02370134|Device|Parkinson's glove|Parkinson's glove had module for detection tremor by gyroscope/acceleroscope and suppression rest hand tremor with electrical muscle stimulation
16071791|NCT02370134|Device|sham glove|
16071792|NCT02370121|Drug|Placebo|Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
16071793|NCT02370121|Drug|Gymnema Sylvestre|Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.
16071794|NCT02370108|Device|electrical muscle stimulation|electrical muscle stimulation at hand muscle for reduction tremor
16071795|NCT02370095|Drug|Treprostinil Inhalation Solution|Treprostinil inhalation solution administered as blinded marketed product
16071796|NCT02370095|Drug|Placebo|Supplied by the manufacturer and similar to the active drug but containing no Treprostinil
16071797|NCT02370082|Device|Localization of breast lesion|localization of breast lesion for removal
16071798|NCT02370069|Biological|Prevnar 13|One dose of 0.5 mL Prevnar 13 injected intramuscularly into the deltoid muscle on Day 0.
16071799|NCT02370056|Diagnostic Test|3-dimensional visualization|Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 3D mode
16071800|NCT02370056|Diagnostic Test|2-dimensional visualization|Subjects are receiving Standard of Care Colectomy for Ulcerative Colitis visualized in 2D mode
16071801|NCT02370043|Drug|KQ-791|Capsules administered orally while fasting, in up to 3 periods
16071802|NCT02370043|Drug|KQ-791 (after meal)|Single dose of KQ-791 in capsules, after a meal, in 1 period
16071803|NCT02370043|Drug|Placebo|Capsules, administered orally, in 1 period
16071804|NCT02370030|Dietary Supplement|Citrulline malate|Active comparator: 10 g/day citrulline malate during 7 days
16071805|NCT02370017|Biological|ANKL(Ex vivo-expanded NK cell enriched lymphocytes)|add ANKL in 3rd and 4th course in case of stable response after two initial courses
16071806|NCT02370004|Procedure|Resistive Flexibility and Strength Training|"RFST is a physical therapy technique where a certified practitioner extends or flexes a joint with the subject actively resists the motion applied by the practitioner.
~During the RFST treatment a subject will lie on a massage table while the practitioner holds the subject's arm or leg and flexes or extends the limb, instructing the patient to resist the flexion or extension produced by the practitioner. The process is repeated a number of times for each muscle while varying joint positions."
16071807|NCT02369991|Procedure|Reconstructive surgery|Patients were treated with free latissimus dorsi flap and bone transport technique
16071808|NCT02369978|Drug|Nifurtimox|Full dose: 8 mg/Kg/day, assuming an average weight of 60 Kg: 240 mg B.I.D Half-dose: 120 mg B.I.D
16071809|NCT02369978|Drug|Benznidazole|Full dose: 5 mg/Kg/day, assuming an average weight of 60 Kg: 150 mg B.I.D Half dose: 75 mg B.I.D
16071810|NCT02369978|Drug|Placebo|Two capsules of matching placebo (contaning Magnesium stearate and cellulose) B.I.D
16071811|NCT02369965|Drug|albuvirtide|albuvirtide 320mg administered intravenously once a week
16071812|NCT02369965|Drug|lopinavir-ritonavir|lopinavir-ritonavir 400/100mg administered orally twice daily
16071813|NCT02369965|Drug|tenofovir|tenofovir 300mg administered orally once daily
16071814|NCT02369965|Drug|lamivudine|lamivudine 300mg administered orally once daily
16071815|NCT02369939|Radiation|Irradiation|Radiotherapy 55,8 Gy - 59,4 Gy
16071816|NCT02369939|Drug|Mitomycin C|MMC w1, w5
16071817|NCT02369939|Drug|5-Fluorouracil|5-FU w1, w5
16071818|NCT02369939|Procedure|Hyperthermia|6x deep regional hyperthermia
16071819|NCT02369926|Procedure|Multiple Sclerosis Functional Composite|The MSFC is a diagnostic test that measures multiple sclerosis symptoms. It includes a timed walk test, 9-hole peg test, and paced auditory serial addition test. The MSFC is administered in-person at the study site.
16071820|NCT02369926|Procedure|Mobile Multiple Sclerosis Functional Composite|The mMSFC is a diagnostic test that measures multiple sclerosis symptoms from. It includes a timed walk test, 9-hole peg test, and paced auditory serial addition test. All aspects of this exam are completed from a participant's home using remote sensing technology and video conferencing.
16071821|NCT02369913|Other|Blood Drawn|Both groups will have 1 teaspoon of blood drawn for analysis.
16071822|NCT02369900|Drug|Esmolol|
16071823|NCT02369900|Other|Saline|
16071824|NCT02369874|Drug|MEDI4736|MEDI4736 Monotherapy
16071825|NCT02369874|Drug|MEDI4736 + Tremelimumab|MEDI4736 + Tremelimumab combination therapy
16071826|NCT02369874|Drug|Standard of Care|Standard of Care
16071827|NCT02369861|Drug|ST266|Topical ocular application 4 times per day
16071828|NCT02369861|Drug|Refresh Lubricant Eye Drops|Topical ocular application 4 timer per day
16071829|NCT02369848|Device|Shockwave Lithoplasty System|
16071830|NCT02369835|Drug|Dakin's solution|Apply modified Dakin's solution (0.005 to 0.01%) topically
16071831|NCT02369835|Other|Placebo|Applied topically
16071832|NCT02369822|Dietary Supplement|Vitamin C|those who are 2-3 years will receive 400 mg/day, 4-8 years will receive 500 mg/day, those who are 9-13 years will receive 1000 mg/day, and from 14-16 years will receive 1500 mg/day
16071833|NCT02369809|Drug|Neovasculgen®|Treatment according to routine clinical practice at the discretion of the treating physician. Patients receive two local intramuscular injections of Neovasculgen® at a course dose of 2.4 mg according to the summary of product characteristics (SmPC).
16071834|NCT02369796|Drug|TAK-448|TAK-448 solution for subcutaneous injection
16071835|NCT02369783|Other|Questionnaire and interview|The aim is to detect social fragility.
16071836|NCT02369770|Device|stretching and active movement training|A portable rehabilitation robot will be used to strongly or gently move the impaired ankle joint back and forth. Then subjects will be asked to use muscles to move the ankle with or without the robotic guidance depending on which group the subjects are in.
16071837|NCT02369757|Behavioral|Navigator intervention|peers sharing common characteristics with the target population whose mission is to accompany towards OCCS
16071838|NCT02369744|Drug|Silodosin|8mg tablet, 1 tab PO daily for 2 weeks
16071839|NCT02369744|Drug|Tamsulosin|0.4 mg Tab, 1 tab PO daily for 2 weeks
16071840|NCT02369718|Other|Listening to 12 Fournier's lists of words|Patients will listen to words from Fournier's lists of words in presence of noise presented at different Signal to Noise Ratio (SNR). 6 disyllable words Fournier's lists are presented to the implantees: SNRs ranged from 0 to 15 decibels (dBs) (0; 3; 6; 9; 12; 15) ; the subjects repeat orally the words. Then microphone is cleaned and, again, 6 Fournier's lists are presented.
16071841|NCT02369718|Other|Listening to 48 Fournier's lists of words|48 disyllable Fournier's lists of words are presented to the subjects (6 SNR*2 coding strategies*4 dirtying levels) and the subjects repeat orally the words. Dirtying levels will be simulated by sounds effects.
16071842|NCT02369692|Device|Magellan Robotic 6 Fr Catheter|The Hansen Medical Magellan™ Robotic Catheter 6 Fr (Magellan™)
16071843|NCT02369679|Device|Precast Adjustable Compression Wrap (Circaid)|"A physiotherapist well trained in lymphedema treatment will apply a lymphatic drainage to the affected upper limb. Then the physiotherapist will apply the precast adjustable compression wrap to the patient. The patient would maintain the precast adjustable compression wrap until the next session of treatment. The first 10 sessions will be daily from Monday to Friday.
~After the 10 first sessions, the treatment will be applied on alternate days (3 per week) until the patient receive a tailored compression garment (7-14 days)."
16071844|NCT02369679|Device|Multilayer Compression Bandages|"A physiotherapist well trained in lymphedema treatment will apply a lymphatic drainage to the affected upper limb. Then the physiotherapist will apply the multilayer bandage to the patient. The patient would maintain the multilayer compression bandage until the next session of treatment. The first 10 sessions will be daily from Monday to Friday.
~After the 10 first sessions, the treatment will be applied on alternate days (3 per week) until the patient receive a tailored compression garment (7-14 days)."
16071845|NCT02369666|Dietary Supplement|LycoRed (code 40051) product|Mixture of tomato lycopene and carotenoids.
16071846|NCT02369666|Dietary Supplement|Placebo|Contains MCT oil.
16071847|NCT02369653|Drug|Apixaban|
16071848|NCT02369653|Other|No systemic anticoagulant prophylaxis|
16071849|NCT02369640|Procedure|Error-management training vs error-avoidance training. Defined by training instructions.|". Error-avoidance training: The participants are instructed to follow the simulator program step-by-step, to achieve the highest possible simulator metric scores by making as few errors as possible, and only to follow the task required in the training program.
~Study group 2. Error-management training: The participants are required to complete the same training program as study group 1. The participants are instructed to experiment and explore on their own and to deliberately make errors during the task that they are instructed to perform. Participants are instructed to reflect on their errors based on the simulator metrics that they do not pass. Errors are framed as positive events and instructor comments may include statements such as the more errors you make, the more you learn! or you have made an error? Great! Because now you can learn something new!"
16071850|NCT02369627|Device|Rapid HIV Self-Test (OraQuick® In-home HIV Test)|The participant will utilize materials and directions contained within the OraQuick In-Home HIV Test kit to properly perform a rapid HIV self-test. The participant will first swab his upper and lower gums using an Oral Swab Test Stick. The participant will then place this device in a test tube, and the results will be displayed in the Test Window within 20 minutes. Test results expire after 40 minutes.
16071929|NCT02368925|Device|Ultherapy™ System|The Investigator will apply to the eligible subject the Study Device Ultherapy™ System with 200~260 lines of 3.0 and 4.5 probe respectively on the subject's neck.
16071851|NCT02369627|Device|Conventional Home-Based HIV Test (Home Access Express)|The participant will utilize materials and directions contained within the Home Access Express HIV-1 Test System to properly perform a conventional home-based HIV test. The participant is required to gather a blood sample by lancing his finger. Blood samples are collected by placing drops of blood on a packaged specimen card. The participant will then mail his blood sample to the Home Access laboratory using a self-addressed, pre-paid shipping envelope. The Home Access laboratory will process the blood sample, and the participant is required to call the facility to learn his HIV test result.
16071852|NCT02369627|Other|Community/Medical-Based HIV Test|The participant will receive a link to a CDC website (https://gettested.cdc.gov) to search for HIV testing locations in his surroudning community. This resource website will provide the participant with places that offer HIV testing for free or at a low cost. The participant also has the option of going to places that can use his insurance or charge for testing. The pariticant is responsible to pay for any testing costs.
16071853|NCT02369614|Other|Active Comparator: 1 Hz rTMS|1 Hz rTMS
16071854|NCT02369614|Other|Active Comparator: 10 Hz rTMS|10 Hz rTMS
16071855|NCT02369614|Other|Sham Comparator:|Sham rTMS
16071856|NCT02369601|Other|non- intervention study|Study design is non-interventional. Patient therapy will not be affected by study participation.
16071857|NCT02369588|Other|Food portion size|
16071859|NCT02369562|Procedure|Evaluation of the failure rate of dental implants|Evaluation of the failure rate of dental implants, from the time of implant insertion (any time between 1980 and August 31st 2014) until September 2015
16071860|NCT02369549|Drug|Micro-particle Curcumin|as described in Arm
16071861|NCT02369549|Drug|Placebo|Looks, smells, tastes and feels exactly like the Curcumin capsules.
16071862|NCT02369536|Dietary Supplement|nutraceutical mixture|Lifestyle counseling, administration of a nutraceutical mixture: fish oil 70% DHA (docosahexaenoic acid), phosphatidylcholine concentrated in sunflower oil, silymarin, choline bitartrate, curcumin, D-α-tocopherol; choline (82,5 mg, corresponding to 15% of the average intake of 550 mg per day in an adult man)
16071863|NCT02369536|Dietary Supplement|placebo|Lifestyle counseling, administration of a placebo, containing only choline, at the same low concentration of the active mixture
16071864|NCT02369523|Drug|Exparel|Mixture of 50 mL of 0.25% Bupivacaine with epinephrine, 40 mL of sterile saline and 20 mL of Exparel®.
16071865|NCT02369523|Drug|Ropivacaine cocktail (PIC)|400 mg Ropivacaine, 5 mg morphine, and 0.4 mg epinephrine in 100 cc solution
16071866|NCT02369523|Drug|Bupivacaine|"Continuous Femoral Nerve Block- 0.25% Bupivacaine at a rate of 5 ml/hour for 48 Hours.
~Sciatic nerve block - 0.125% bupivacaine"
16071867|NCT02369510|Drug|Low-dose epinephrine|0.1ml of preservative-free saline and 0.1ml of 1:1000 epinephrine will be added to the standard spinal medications
16071868|NCT02369510|Drug|High-dose epinephrine|0.2ml of 1:1000 epinephrine will be added to the standard spinal medications
16071869|NCT02369510|Drug|No epinephrine|0.2ml of preservative-free saline will be added to the standard spinal medications
16071870|NCT02369497|Device|HRA|Humeral head resurfacing with the HRA device
16071871|NCT02369484|Drug|Afatinib|40mg p.o./ day until documented progression or unacceptable toxicity
16071872|NCT02369471|Drug|GWP42006|
16071873|NCT02369471|Drug|Placebo|
16071876|NCT02369445|Behavioral|Moisture Pager Intervention for Toilet Training|
16071877|NCT02369445|Behavioral|Standard of Care|
16071878|NCT02369432|Drug|Biodegradable and biocompatible polymeric microparticles containing a fluorochrome applied to the skin followed by a skin biopsy|
16071879|NCT02369419|Other|Frailty|CRT device is implanted in all patients selected for the study. Frailty is evaluated before implant and defined as <14/17 points using the ONCODAGE score
16071880|NCT02369406|Drug|Nevirapine|
16071881|NCT02369406|Drug|Kaletra|
16071882|NCT02369406|Drug|Lamivudine|
16071883|NCT02369406|Drug|Zidovudine|
16071884|NCT02369393|Behavioral|Behavioral Activation|Behavioral Activation intervention promotes the involvement in meaningful activities close to personal values.
16071885|NCT02369393|Behavioral|Physical Activity|Physical Activity intervention promotes the gradual increase of the frequency and intensity of PA levels, with special attention to motivational strategies.
16071886|NCT02369380|Device|Hyaluronic acid|Injections of Hyaluronic acid under the metatarsal heads
16071887|NCT02369354|Behavioral|TALKS Social Worker Intervention|TALKS includes a video and book that describe patient and family experiences with talking about and considering live kidney transplantation. TALKS also includes a social worker meeting. Potential recipients meet with a transplant social worker for up to 60 minutes to identify potential barriers to considering or pursuing live donor kidney transplantation. They also are invited to have a second meeting with family and/or friends with the social worker for up to 60 minutes.
16071888|NCT02369354|Other|Financial Assistance Intervention|"The financial assistance intervention offers potential donors the ability to draw from a bank of $2100 to reimburse their costs related to being evaluated for live kidney donation or for donating a kidney. Costs include, but are not limited to: child care, travel, time off work, and other out of pocket expenses related to being evaluated to become a live kidney donor or to donating."
16071889|NCT02369341|Biological|Fluarix Tetra|One dose of the Fluarix™ Tetra vaccine was administered to all subjects on Day 0 (Visit 1) intramuscularly into the deltoid of the non-dominant arm.
16071890|NCT02369328|Device|MULTIMODAL MRI|Multimodal MRI (including perfusion MRI, sodium MRI, resting-state functional MRI, high resolution anatomical MRI) will be carried on at the inclusion, after 24 hours, at 3 months and at 12 months and neurological clinical exam , rankin score, NIHSS
16071891|NCT02369315|Behavioral|Treatment (Invited entry 2012)|Entry to music program offered in September 2012
16071892|NCT02369315|Behavioral|Control (Invited entry 2013)|Entry to music program offered in September 2013
16071893|NCT02369302|Drug|DWC20141|Tablet
16071894|NCT02369302|Drug|DWC20142|Tablet
16071895|NCT02369302|Drug|DWC20141, DWC20142|Tablet
16071896|NCT02369289|Other|bone mineral density test|
16072908|NCT02361645|Drug|Bromfenac 0.09% eyedrops|
16071897|NCT02369276|Other|ultrasonography and elastography|Evaluate the soft tissue of shoulder girdle with musculoskeletal ultrasonography and elastography, compare the finding in each group and the range of motion of their shoulder, the severity of wing scapula, visual pain analog scale and the score of The Disability of Arm, Shoulder and Hand
16071898|NCT02369250|Drug|Rosuvastatin|Rosuvastatin, is a statin group of drug.
16071899|NCT02369250|Biological|platelet rich fibrin|AUTOLOGUS PLATELET GROWTH FACTOR
16071900|NCT02369211|Drug|Acetaminophen (Ofirmev)|The patient was administered IV Ofirmev during anesthesia and then 3 more IV doses (1g each) every 6 hours up to 24 hrs.
16071901|NCT02369211|Other|Placebo|The patient was administered IV Placebo during anesthesia and then 3 more doses of IV Placebo every 6 hours up to 24 hrs.
16071902|NCT02369198|Drug|TargomiRs|"TargomiRs are targeted minicells containing a microRNA mimic. They consist of three components: 1. A miR-16-based microRNA mimic. The miR-16 family has been implicated as a tumour suppressor in a range of cancer types. The mimic is a double-stranded, 23 base pair, synthetic RNA molecule. 2. Drug delivery vehicle - EDVs. EDVs are nonliving bacterial minicells (nanoparticles). They function as leak resistant micro-reservoir carriers that allow efficient packaging of a range of different drugs, proteins or nucleic acids. 3. Targeting moiety. The EDVs are targeted to EGFR-expressing cancer cells with an anti-EGFR bispecific antibody.
~TargomiRs are IV injected."
16071903|NCT02369172|Drug|Bupropion|
16071904|NCT02369172|Drug|ASP2151|
16071905|NCT02369159|Drug|Peramivir|
16071906|NCT02369159|Drug|Oseltamivir|
16071907|NCT02369146|Drug|UB-421|The UB-421 (dB4C7 mAb) will be supplied at a concentration of 10 mg/mL (100 mg in 10 mL vial). Subjects will receive 8 doses of the UB-421 by intravenous infusion at 10 mg/kg weekly (Cohort 1, 8 weeks) or 25 mg/kg bi-weekly (Cohort 2, 16 weeks).
16071908|NCT02369133|Drug|paracetamol|Drugs were given intravenously by a nurse unaware of the study 15 min before surgery. Patients in group P (n = 30) received 1 g iv paracetamol, patients in group S (n = 30) received 100 ml iv %0.9 NaCl
16071909|NCT02369133|Drug|Placebo|
16071910|NCT02369120|Other|Educational intervention|The internet platform will provide patients with customized tasks that allow them to use the metaphor of the journey (the narrative as a dynamic of the game) to feel that they manage their own path, which will change negative perceptions into positive perceptions about certain actions. At all times, the patients will be able to choose among different information sources, such as videos about the origin of chronic pain, 3D representations of different neurophysiological processes, and FAQs. Additionally, the patients will be able to contact a specialist in the neurophysiology of pain by email or videoconference. Furthermore, to reinforce patients' motivation and participation, gamification techniques will be implemented.
16071911|NCT02369120|Other|Normal care by GP|Patients will follow GP advice including NSAID medication if needed
16071912|NCT02369107|Other|Verum acupuncture and medicine|Participants will receive acupuncture therapy 1 hour prior to chemotherapy administration ，6 hours after chemotherapy administration，and once acupuncture therapy on the following day2,3,4,5. The stimulation points are RN12,LR13(bilaterally), RN6, ST25(bilaterally), PC6(bilaterally), ST36(bilaterally). The acupuncture needle in ST36 and auxiliary point will be connected to form a circuit containing a SDZ-V stimulator for 30 min with a frequency of 2/100 Hz. They will receive 8mg Ondansetron Intravenously twice a day during the chemotherapy administration period (5 days in total).
16071913|NCT02369107|Other|Sham acupuncture and medicine|Participants will receive minimal acupuncture therapy at the same time as the intervention group .The stimulation points are not belong to traditional Chinese medicine.They will receive 8mg Ondansetron Intravenously twice a day during the chemotherapy administration period (5 days in total).
16071914|NCT02369094|Other|acupressure|A 15 minutes structured acupressure protocol with specific acupoints and applications technique will be performed on the elderly participants twice a week by the research team in YCHSS centers. The caregiver of the elderly will be trained and perform the same acupressure protocol on the elderly at 2 additional occasions during the week. The total trial period is 12 weeks.
16071915|NCT02369081|Drug|Spironolactone|Spironolactone 25mg tablet orally once daily for 6 weeks, followed by Spironolactone 50mg tablet orally once daily for a further 6 weeks.
16071916|NCT02369081|Drug|Bisoprolol|Bisoprolol 5mg tablet orally once each day for 6 weeks, followed by Bisoprolol 10mg tablet orally once each day for a further 6 weeks.
16071917|NCT02369081|Drug|Doxazosin|Doxazosin 4mg tablet orally once daily for 6 weeks, followed by Doxazosin 8mg tablet orally once daily for a further 6 weeks.
16071918|NCT02369081|Drug|Placebo|Placebo treatment for 12 weeks.
16071919|NCT02369068|Drug|Onabotulinumtoxin A|Intravaginal pelvic floor injection one series
16071920|NCT02369068|Drug|Kenalog|Intravaginal pelvic floor injection one series
16071921|NCT02369042|Device|Kyma Device u-Cor System|The Kyma uCor system externally measures thoracic fluid content, heart rate, respiratory rate, posture and movement. The system includes a flat antenna that is attached to the patient's torso with a bandage-like sticker. The antenna transmits radio waves and receives their reflections from the body for several seconds every few hours throughout the day.The data is recorded and collected then compared to traditional clinical parameters.
16071922|NCT02369029|Drug|BAY 1238097|Oral administration twice weekly. Starting dose will be 10 mg per week and dose will be escalated dependent on any dose limiting toxicities.
16071923|NCT02369016|Drug|Copanlisib (BAY 80-6946)|60 mg of experimental drug in solution administered intravenously on Days 1, 8 and 15 of each 28-day treatment cycle
16071924|NCT02369003|Procedure|Autologous Peripheral Nerve Graft|Implantation of Autologous Peripheral Nerve Graft into the substantia nigra, basal forebrain, putamen, and/or STN of participants with PD undergoing deep brain stimulation (DBS) surgery.
16071925|NCT02368977|Device|Third Eye Panoramic device|A Third Eye Panoramic device will be attached to the tip of the colonoscope and will provide two additional views from laterally-oriented video cameras during the colonoscopy procedure.
16071926|NCT02368964|Drug|GnRH agonist 0.2 mg + hCG 250 mcg|Treatment for triggering
16071927|NCT02368964|Drug|high dose hCG 500 mcg|Treatment for triggering
16071928|NCT02368951|Drug|BAY1187982|A dose of 0.1 mg BAY 1187982 per kilogram (kg) body weight (BW) was chosen as the starting dose based on toxicology data. The investigational drug will be administered as a 1-hour IV infusion once every 21 days at the trial site (Day 1 of each 21-day Cycle). The maximum possible dose escalation will be 2-fold and not more than 0.5 mg/kg BW until maximum tolerated dose is selected
16071930|NCT02368912|Drug|ASP1707 single dose of dose levels 1 -7|Oral, dose escalation
16071931|NCT02368912|Drug|Placebo single dose of dose levels 1-7|Oral, dose escalation, healthy young male
16071932|NCT02368912|Drug|ASP1707 single dose fasted|Oral, healthy young male
16071933|NCT02368912|Drug|ASP1707 single dose fed|Oral, healthy young male
16071934|NCT02368912|Drug|ASP1707 multiple dose of dose levels 1-4|Oral, multiple dose escalation, healthy elderly male
16071935|NCT02368912|Drug|Placebo multiple dose of dose levels 1-4|Oral, multiple dose escalation, healthy elderly male
16071936|NCT02368912|Drug|ASP1707 multiple dose of dose levels 1-2|Oral, multiple dose escalation, healthy pre-menopausal female
16071937|NCT02368912|Drug|Placebo multiple dose of dose levels 1-2|Oral, multiple dose escalation, healthy pre-menopausal female
16071938|NCT02368912|Drug|ASP1707 parallel multiple dose of dose levels 1-3|Oral, multiple dose, healthy pre-menopausal female
16071939|NCT02368912|Drug|Placebo parallel multiple dose|Oral, dose escalation, healthy pre-menopausal female
16071940|NCT02368899|Other|Computerized Alcohol Misuse Intervention|Interventionaire© is a computerized alcohol misuse intervention that includes a normative feedback component unique in its micro-targeting of alcohol use feedback based on participant demographic characteristics (race/ethnicity, gender, and age), drawing population normative data from the National Surveys on Drug Use and Health. This represents a novel use of epidemiological data to inform clinical services.
16071941|NCT02368899|Other|Attention Control (AC)|These products are designed for entertainment and educational purposes only. No medical claims are made for them and, the participant's interaction with them should be conceptually unrelated to alcohol use behavior.In order to avoid any carryover effect from comparing two active treatments, we have chosen to use a simple attention control condition that is not expected to exert any real intervention effect. In that way, the effect size estimate of the intervention can be readily calculated. No research data will be collected as part of the AC, beyond the amount of time spent on the program.
16071942|NCT02368886|Drug|Clobetasol Propionate|Given topically
16071943|NCT02368886|Other|Pharmacological Study|Correlative studies
16071944|NCT02368886|Other|Quality-of-Life Assessment|Ancillary studies
16071945|NCT02368886|Drug|Regorafenib|Given PO
16071946|NCT02368873|Procedure|Application of IPOM mesh|
16071947|NCT02368860|Drug|oxaliplatin, irinotecan, capecitabine|fixed doses of intravenous oxaliplatin 50 mg/m2, and intravenous irinotecan administered on days 1 and 8 in a 21 day-cycle while xeloda will be administered daily at around midnight from day 1 to day 14
16071948|NCT02368847|Device|Diagnostic tests|C Reactive Protein (CRP) measurement on capillary blood using a point-of-care test to determine C Reactive Protein level in the blood
16071949|NCT02368847|Device|Diagnostic tests|Uricult dipslide: Easy-to-perform bacterial culture test for dectecting urinary tract infections in point of care settings
16071950|NCT02368834|Behavioral|psychoeducation|The intervention included a presentation by a psychiatrist, with parent manual provided, and then two group sessions at the 2nd and 4th weeks to address further concerns of the parents
16071951|NCT02368808|Behavioral|Abangane Support Group|The Abangane support group program consists of 8 sessions for bereaved adolescents with standardized activities and discussion content based the Khululeka Grief Support Program in Cape Town, South Africa. The materials include a resource book that provides training and referral agencies for grief group facilitators as well as exercises and creative activities designed to stimulate group discussions that will help adolescents to deal with loss and grief.
16071952|NCT02368795|Device|Pancreatic Stent|A 5-Fr, 4-cm-long stent (Endoflex) with a single duodenal pigtail is used for pancreatic duct stenting
16071953|NCT02368795|Drug|Indomethacin|Indomethacin 100 mg suppository ten minutes before ERCP
16071954|NCT02368795|Drug|Isosorbide Dinitrate|Sublingual Isosorbide dinitrate 5 mg before ERCP
16071955|NCT02368795|Drug|Ringer's lactate|IV Ringer's lactate serum with a dose of 6 cc/kg/h during the procedure and 20 cc/kg after ERCP as a bolus dose and 3 cc/kg/h for the next 8 hours.
16071956|NCT02368769|Device|During Tele-expertise|
16071957|NCT02368743|Drug|mesalazine|
16071958|NCT02368730|Drug|desmopressin|
16071959|NCT02368717|Drug|Mesalazine Enema|
16071960|NCT02368717|Drug|Placebo Enema|
16071961|NCT02368704|Other|No intervention|
16071962|NCT02368691|Drug|GTx-024|GTx-024 softgel capsules will be administered once-daily to a total dose of 18 mg
16071963|NCT02368678|Procedure|Scaling and Root Planning (SRP)|"Scaling and Root Planing (n=15): quadrant-wise scaling and root planing performed within four weekly session (30 min. per quadrant).
~Oral malodor was measured by organoleptic test and Oral Chroma (Abilit, Osaka Japan) prior to the oral examination, at Baseline and also at 90 days after treatment. Clinical monitoring and tongue coating index were taken at these same times.
~Oral hygiene instructions were given to all participants."
16071964|NCT02368678|Procedure|Full Mouth Scaling (FMS)|"Full Mouth Scaling (n=15): scaling and root planning was performed in a single stage (within 24 hours); two sessions (60 min. per session) in two consecutive days.
~Oral malodor was measured by organoleptic test and Oral Chroma (Abilit, Osaka Japan) prior to the oral examination, at Baseline and also at 90 days after treatment. Clinical monitoring and tongue coating index were taken at these same times.
~Oral hygiene instructions were given to all participants."
16071965|NCT02368665|Drug|Amlodipine 5mg|- Daily oral administration for 8 weeks
16071966|NCT02368665|Drug|Amlodipine 5mg, Candesartan cilexetil 16mg|- Daily oral administration Amlodipine 5mg for 8 weeks
16071967|NCT02368665|Drug|Amlodipine 10mg, Candesartan cilexetil 16mg|- After 8 weeks of administration, Amlodipine 10mg and Candesartan cilexetil 16mg once a day for 8 weeks
16071968|NCT02368652|Drug|Candesartan cilexetil 16mg|Daily oral administration for 8 weeks
16071969|NCT02368652|Drug|Amlodipine 10mg, Candesartan cilexetil 16mg|Daily oral administration for 8 weeks
16071970|NCT02368639|Device|Fisher & Paykel Healthcare PAP Device|The device is a modified version of the Fisher & Paykel Icon continuous positive airway pressure (CPAP) device, which is a fully released product in New Zealand.
16071971|NCT02368626|Device|EndyMed Pro™ RF Micro-Needles|RF Micro-needles ablation treatments
16071972|NCT02368613|Drug|DW-3102|
16072004|NCT02368340|Other|Sample collection|Blood and urine sample collections
16072005|NCT02368327|Biological|Fluad|
16071973|NCT02368600|Behavioral|Lifestyle modification program|On top of the usual care, subjects in the intervention will receive a lifestyle intervention that will be delivered by experienced registered dietitian and exercise specialist. There will be 5 face-to-face dietitian consultations, 2 telephone dietitian consultations and at least one face-to-face exercise specialist consultation. The exercise consultation will be normally scheduled on the same day of the face-to-face dietitian consultation.
16071974|NCT02368587|Biological|WJMSCs Vs. placebo|WJMSCs Vs. placebo
16071975|NCT02368587|Biological|Placebo|WJMSCs Vs. placebo
16071976|NCT02368574|Procedure|Class II hysterectomy|Class II hysterectomy
16071977|NCT02368561|Drug|"Injection of Hyaluronic Acid - SYNVISC (hylan G-F 20)"|US guided weekly injection of sodium hyaluronate administered for 3 week in adult subjects with insertional achilles tendinopathy
16071978|NCT02368548|Other|Pharmaceutical Care Program|Intensive pharmaceutical care program, initiated in the emergency department, as described in its corresponding arm intervention description.
16071979|NCT02368548|Other|Standard Care|Standard pharmaceutical care process, initiated at the hospital admission, as described in its corresponding arm intervention description.
16071980|NCT02368535|Other|Survey|25-item questionnaire on pereception of interdisciplinary rounds
16071981|NCT02368509|Other|Perform sensory tests|
16071982|NCT02368496|Device|HR-pQCT|
16071983|NCT02368483|Other|Neuromuscular training|Neuromuscular training for the hip and lower limb muscles.The training program is divided into 3 phases, and includes specific exercises for improving the hip range of motion, muscle strength of the hip and lower limb muscles, as well as the trunk stability and coordination. The intervention lasts 12 weeks. Patients will train 2 times/week with a physical therapist and 2 times/weeks alone at home.
16071984|NCT02368470|Drug|Gemifloxacin-based triple therapy|Rabeprazole (Rabiet®, ildong pharmaceutical Co. Ltd., Seoul, Korea) 20 mg twice daily, amoxicillin (Pamoxin®, Dongwha Co. Ltd., Seoul, Korea) 1 g twice daily, and gemifloxacin (Factive®, LG Life Sciences, Ltd, Seoul, Korea) 320 mg once daily for 7 days
16071985|NCT02368470|Drug|Standard triple therapy|Rabeprazole (Rabiet®, ildong pharmaceutical Co. Ltd., Seoul, Korea) 20 mg twice daily, amoxicillin (Pamoxin®, Dongwha Co. Ltd., Seoul, Korea) 1 g twice daily, and clarithromycin (Klaricid®, Abbot Korea Co. Ltd., Seoul, Korea) 500 mg twice daily for 7 days
16071986|NCT02368457|Drug|Pentoxifylline and Tocopherol|pentoxifylline with tocopherol Pentoxifylline 800 mg/day, oral (1cp 400 mg twice a day) + Vitamin E (alfa-tocopherol) 1000 UI/day, oral (1cp 400UI twice a day + 1cp200UI once a day) during 24 months (maximum).
16071987|NCT02368444|Behavioral|Cognitive Behavioral Therapy and Yoga|Group Cognitive Behavioral Therapy Treatment and Yoga Program
16071988|NCT02368431|Drug|Zonisamide|Titration of dose to 500mg oral, daily, over 8 weeks, then 7 weeks of treatment at that dose
16071989|NCT02368431|Drug|Placebo|Placebo
16071990|NCT02368418|Procedure|PCP|PCP is short for the standard disease management program of individuals at high risk of cardiovascular disease delivered by Primary Care Providers (village doctors).
16071991|NCT02368418|Procedure|SRS|SRS is short for a community-based Salt Reduction program delivered by community health educators.
16071992|NCT02368405|Behavioral|Control|Participants in the control group will receive the standard nutrition lecture currently given at Carolinas Rehabilitation to all inpatients with spinal cord injuries. This one lecture is what is required by Commission on Accreditation for Rehabilitation Facilities (CARF)
16071993|NCT02368405|Behavioral|Eat Smart, Live Better|Intervention participants will participate in a series of six, 60-minute small group sessions of interactive nutrition education discussions led by a Registered Dietitian delivered over 3 weeks. They will also have one follow-up comprehensive nutrition education session approximately 3 months after receipt of the Eat Smart, Live Better curriculum. In order to help us assess the effectiveness of the nutrition education program, we will assess nutrition behavior and knowledge at this time as well. Community participants in the treatment group will attend the sessions at Carolinas Rehabilitation (CR). The control participants from the community will come to CR for the one standard nutrition lecture. Caregivers and spouses of all of the participants will be encouraged to attend the sessions.
16071994|NCT02368392|Other|Exposure for cardiac arrests|There is no particular intervention. This study merely observes the occurrence of cardiac arrests
16071995|NCT02368379|Other|Low dose (1 mcg) ACTH stimulation test|Subjects will have baseline cortisol and ACTH drawn followed by administration of 1 mcg/m2 (max 1 mcg) of cortrosyn. Blood will be drawn at 20 and 40 minutes post cortrosyn for peak cortisol assessment of central adrenal insufficiency.
16071996|NCT02368379|Other|Overnight metyrapone test|Subjects will receive metyrapone 30 mg/kg (max 3 grams) by mouth at midnight. Blood will be drawn at 0800 AM the following morning for ACTH, cortisol and 11 deoxycortisol for assessment of central adrenal insufficiency.
16071997|NCT02368366|Behavioral|Therapist Guided Face to Face Family Problem Solving|Families assigned to this arm will meet with the therapist in person at the medical center TBI clinic. Sessions will last approximately 60 minutes and cover didactic content using printed handouts provided as part of a family workbook.
16071998|NCT02368366|Behavioral|Therapist Guided Online Family Problem Solving|Families assigned to this arm will receive a password enabling them to access the online intervention materials throughout the course of the intervention. Each session of online F-PST consists of a self-guided online portion providing didactic content regarding the desired skill (i.e., problem-solving), video clips showing individuals and families modeling the skill, and exercises and assignments giving the family an opportunity to practice the skill. During synchronous, videoconference sessions with the therapist, the family will review the online materials and practice the problem-solving process.
16071999|NCT02368366|Behavioral|Self-Guided Online Family Problem Solving|Families in the self-guided, online F-PST arm will receive a password enabling them to access the online intervention materials throughout the course of the intervention. They will receive access to the same web-modules as the therapist-guided group, but will review them on their own without therapist support. Participants in this group will be encouraged to complete web modules at the same schedule as participants in the other groups. If the family fails to log on or complete web modules, they will receive reminders via phone, text, or e-mail.
16072000|NCT02368353|Other|Cognitive behavioral therapy|
16072001|NCT02368353|Other|Supportive therapy|
16072002|NCT02368340|Other|Pulmonary function test|Pulmonary function testing performed
16072003|NCT02368340|Other|Chest CT|Chest CT scan to evaluate for pulmonary fibrosis
16072008|NCT02368314|Drug|Sodium Enoxaparine|30 mg (0,3 ml), subcutaneously, twice a day (every 12 h).
16072009|NCT02368301|Drug|Elotuzumab in combination with Lenalidomide and Dexamethasone|
16072010|NCT02368288|Drug|entecavir|in this group, entecavir will added, and patients will receive treatment of PEG-IFN a-2a combine with entecavir for 48 week.
16072011|NCT02368262|Other|Questionnaire and micturition and drinking diaries|"Questionnaire: ICCS parental questionnaire + extended history taking document, ROME III criteria, demographic information and/or PIN-Q.
~Diaries: 24-hour voiding chart"
16072012|NCT02368262|Procedure|Uroflowmetry, pelvic floor EMG and bladderscan|Voiding variables, pelvic floor activity during micturition and postmictional residue.
16072013|NCT02368249|Drug|Terlipressin|Patients are receiving a post-operative intravenous terlipressin treatment in association with human albumin to preserve the renal function
16072014|NCT02368249|Drug|Placebo|Patients are receiving a post-operative intravenous Ringer's lactate solution
16072015|NCT02368236|Behavioral|Tailored Printout|The Cancer Risk Intake System (CRIS) is a tablet-based program through which patients answer detailed questions about their colorectal cancer risk prior to an appointment. Tailoring algorithms in CRIS generate printed information for patients and their physicians summarizing their risk factors and matching them with guideline-based screening options.
16072016|NCT02368223|Device|YouGrabber|2 weeks of home-based therapy with a virtual-reality enhanced upper limb training system
16072017|NCT02368210|Drug|122-0551 Foam|Topical Foam
16072018|NCT02368210|Drug|Vehicle Foam|Topical Foam
16072019|NCT02368197|Drug|paclitaxel (Cardionovum Legflow drug eluting balloon)|Elution of paclitaxel from inflated balloon catheter into vessel wall
16072020|NCT02368197|Device|Balloon angioplasty (Bard Dorado)|Dilatation of cephalic arch venous stenosis by radial force applied by a balloon catheter
16072021|NCT02368171|Other|measure exhaled carbon monoxide and nitric oxide|
16072022|NCT02368158|Other|Driving simulation with elevation of medical data in comparison to Lane Change Test plus automotive monitoring via contactless sensors|During a driving simulation medical data are elevated such as electrocardiography (ECG), heart rate breathing rate and oxygen saturation and compared to data of the performed Lane Change Test as a measurement for the quality of driving. Hereby the deviation of the lane from baseline during driving and ordered lane change via signs are determined also when performing cognitive and visual tasks. Also the simulation is simultaneously accompanied by monitoring via contactless camera usage in regard to possible determination of heart and breathing rate according to Eulerian Magnification Method
16072023|NCT02368132|Behavioral|Group Delivered TEP|All TEP modules will be in a group format. Each call will take 1.5-2 hours. Each group will be comprised of 5-8 CGs who will call into a teleconference line at a pre-specified time. Groups will include spouse/partner-only or adult child-only CGs. The content of the calls will mirror those in the individual TEP delivered program. In addition to the group calls, they will receive individual care management.
16072024|NCT02368132|Behavioral|Individual Delivered TEP|Two mandatory modules that cover the stages of dementia and provide a brief introduction to problem solving techniques, action plan development, and coping skills, plus a menu of additional modules covering various content areas evaluated during the course of the monthly assessments (e.g., communication skills, behavioral management techniques, stress management and coping skills, longterm planning, etc.). Each individual TEP session will begin with reviewing education related to the selected module. The remainder of each session will involve coaching the caregiver on emotion-focused and problem focused coping strategies. The care manager will also discuss problem solving with the CG to reinforce the action plan and the educational component of the intervention.
16072025|NCT02368119|Biological|VRC-EBOADC069-00-vp|IM Injection of cAd3-EBO bivalent (Zaire plus Sudan) vaccine (2 x 10(10) vp)
16072026|NCT02368119|Biological|VRC-EBOADC069-00-vp|IM Injection of cAd3-EBO bivalent (Zaire plus Sudan) vaccine (2 x 10(11) vp)
16072027|NCT02368119|Biological|MVA-EbolaZ|IM injection of MVA-EbolaZ vaccine
16072028|NCT02368119|Other|Placebo|IM injection injection of Phosphate Buffered Saline
16072029|NCT02368106|Radiation|Radiation Therapy|targeted radiation treatment
16072030|NCT02368093|Drug|Dextromethorphan hydrobromide|120mg per day with once daily dose taken after breakfast for 6 months
16072031|NCT02368080|Device|"Comparison of two MBWN2 devices : EasyOne Pro Lab versus Exhalyzer D"|Healthy and Cystic Fibrosis participants will perform the same day MBWN2 tests in duplicate with each device.
16072032|NCT02368067|Procedure|Standard of Care Sentinal Node Dye|Delivery of sentinal node dye by different routes
16072033|NCT02368067|Procedure|Study Sentinal Node Dye|Patients will receive different types of dye by different routes of administration
16072034|NCT02368054|Drug|Bupivacaine|Infiltration anesthesia
16072035|NCT02368054|Drug|Adrenaline|Infiltration anesthesia
16072036|NCT02368041|Device|InSpectraTM StO2 monitor|InSpectraTM StO2 monitor manufactured by Hutchinson Technology Inc. to measure the baseline StO2 level after applying the noninvasive probe to the thenar eminence. After a stable reading is obtained a blood pressure cuff will be inflated 40 mmHg above the obtained systolic pressure and the rate of desaturation (Rdes; % × sec-1) will be recorded. After 3 minutes or once the StO2 level comes to zero, whichever is earlier the cuff pressure will be released instantaneously and the rate of reperfusion (Rres; % × sec-1) will be measured. The measurement will be continued until the StO2 returns to the baseline value.
16072037|NCT02368028|Other|Oral Samples|Oral samples of saliva, dental plaque and DNA will be collected between the two groups.
16072038|NCT02368015|Other|Peripheral intravenous cannula (IVC)|Blood samples will be withdrawn prior, during and after the procedure using an additional peripheral intravenous cannula (IVC).
16072039|NCT02368015|Drug|cefazolin|
16072040|NCT02368002|Behavioral|Behavioral weight loss therapy|All participants start with behavioral weight loss therapy which consists of 20 weekly meetings wtih a weight loss coach. Session components will include weekly weigh-in, discussion of progress and challenges and discussion of scheduled session topic. Dietary goals and physical activity goals are set. After their first session, participants are randomized to have their weight assessed at either their 3rd session or their 7th session. Both the participant and their coach are blinded to the randomization. If the participant has lost the expected amount of weight, they continue with behavioral weight loss therapy for the full 20 session.
16072173|NCT02367027|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Single dose of 10 mg oral suspension in fasted conditions.
16072041|NCT02368002|Behavioral|Meal replacements|"Participants continue with behavioral weight loss therapy, but this is augmented with meal replacements (MR). Adherence to energy intake goals is facilitated by consuming pre-prepared meals specifically designed to meet caloric intake guidelines. MRs reduce individuals' motivationally- and self-regulatory-dependent planning and decision making around eating. MRs also serve as a teaching tool regarding the amount and type of food people should eat in order to produce weight loss."
16072042|NCT02368002|Behavioral|Enhanced behavioral weight loss therapy|Switching the therapeutic approach to an enhanced behavioral weight loss therapy teaching acceptance based behavioral skills theoretically addresses the root problem of many weight loss challenges and boosts long-term capacity for self-regulation. Acceptance based strategies are designed to help participants identify and internalize values and lasting commitment to behavior consistent with these values. The strategies focus on increasing people's ability to forgo more pleasurable options (e.g., hedonic pleasure of food) in favor of behavior that is distinctly less pleasurable or even aversive (remaining hungry, anxious, bored). The inability to tolerate such distress is directly associated with failure of self-regulation.
16072043|NCT02367989|Dietary Supplement|0g barley β-glucan no fibre|Food containing no barley β-glucan and no additional fibre
16072044|NCT02367989|Dietary Supplement|2g barley β-glucan|Food containing low amounts of barley β-glucan
16072045|NCT02367989|Dietary Supplement|4g barley β-glucan|Food containing medium amounts of barley β-glucan
16072046|NCT02367989|Dietary Supplement|6g barley β-glucan|Food containing high amounts of barley β-glucan
16072047|NCT02367989|Dietary Supplement|0g barley β-glucan with fibre|Food containing no barley β-glucan, but matches fibre content in β-glucan treatments
16072048|NCT02367976|Drug|rhprouk|rh-prouk will be administrated within 60 minutes after the patients eligibility confirmed
16072049|NCT02367963|Behavioral|Training period|Six workshops in which education on health habits and encouragement to reduce risk factors was promoted. Workshops addressed rigorous, accurate and effective technical information but were tailored to general public to ensure that subjects became aware of the importance of change in their overall health. Workshops led by experts dealt with the following relevant subjects: Motivation to Change; Physical Activity, Healthy Diet, Smoking Cessation; Stress Management and Self-control of Blood Pressure.
16072050|NCT02367963|Behavioral|Peer-group|The ultimate goal is to reinforce the self-accountability in the subjects and nurture their self-care. It is designed to make the subjects participate actively in their healthcare. Through the different activities subjects will begin to successfully make various changes that increase their confidence in the ability to manage risk factors and problems arising from unhealthy habits. Along the twelve sessions (60-90 minutes) subjects propose assumable health goals; learn to manage their emotions, to resolve problems, to control their diet, to increase their physical activity, to control their state of mind and how the acquisition or not of healthy habits influences their relationships.
16072051|NCT02367950|Behavioral|Exercise|10 exercise sessions with a personal trainer
16072052|NCT02367937|Drug|PRC-4016 (icosabutate)|"Midazolam, omeprazole, flurbiprofen and simvastatin interaction with PRC-4016. Detailed description under Study description"
16072053|NCT02367924|Drug|trabectedin|The administration of chemotherapy regimen with trabectedin (according to Summary of Product Characteristics (SmPC)) will be determined by the Investigator's discretion depending on the patients' conditions and previous chemotherapy.
16072054|NCT02367911|Drug|122-0551 Foam|122-0551 Foam applied twice daily to treat psoriasis
16072055|NCT02367911|Drug|Vehicle Foam|Vehicle Foam applied twice daily to treat psoriasis
16072056|NCT02367898|Other|Lumosity Cognitive Training|adaptive online cognitive training
16072057|NCT02367898|Other|Crossword Puzzles|timed online crossword puzzles
16072058|NCT02367885|Drug|TAK-850 0.5 mL injection|TAK-850 injection
16072059|NCT02367885|Drug|TAK-850 0.25 mL injection|TAK-850 intramuscular injection
16072060|NCT02367872|Drug|TAK-272|TAK-272 tablet
16072061|NCT02367859|Drug|Dabrafenib|Given PO
16072062|NCT02367859|Drug|Trametinib|Given PO
16072063|NCT02367846|Drug|Combined Oral Contraceptive (COC)|The proposed study is a preclinical, multi-site trial comparing the short-term effects of oral vs. non-oral ethinyl estradiol on net bone calcium balance. A prospective crossover study with repeated measures and a simple random assignment will be used to test the effects of 49 days of COC use on bone metabolism using 41Ca to determine net bone calcium balance. Subjects will be randomized to receive COC during either the first or second intervention period.
16072064|NCT02367846|Drug|Contraceptive Vaginal Ring (CVR)|The proposed study is a preclinical, multi-site trial comparing the short-term effects of oral vs. non-oral ethinyl estradiol on net bone calcium balance. A prospective crossover study with repeated measures and a simple random assignment will be used to test the effects of 49 days of CVR use on bone metabolism using 41Ca to determine net bone calcium balance. Subjects will be randomized to receive CVR during either the first or second intervention period.
16072065|NCT02367833|Drug|Combined Oral Contraceptive|The proposed study is a preclinical, multi-site trial comparing the short-term effects of oral and non-oral ethinyl estradiol on the GH/IGF-1 axis and bone metabolism. Using a prospective repeated measures design, we will test the effects of 2 cycles of combined oral contraceptive (Apri or Reclipsen) on the GH/IGF-1 axis.
16072066|NCT02367833|Drug|Transdermal Contraceptive|The proposed study is a preclinical, multi-site trial comparing the short-term effects of oral and non-oral ethinyl estradiol on the GH/IGF-1 axis and bone metabolism. Using a prospective repeated measures design, we will test the effects of 2 cycles of a transdermal contraceptive (Xulane) on the GH/IGF-1 axis.
16072067|NCT02367833|Drug|Contraceptive Vaginal Ring|The proposed study is a preclinical, multi-site trial comparing the short-term effects of oral and non-oral ethinyl estradiol on the GH/IGF-1 axis and bone metabolism. Using a prospective repeated measures design, we will test the effects of 2 cycles of vaginal ring contraceptive (Nuva Ring) on the GH/IGF-1 axis.
16072068|NCT02367820|Drug|NKTR-181 BID tablets|NKTR-181 tablets 100-600 mg twice daily (BID)
16072069|NCT02367807|Drug|Emtricitabine and tenofovir disoproxil fumarate|This study will enroll 50 subjects who are offered TDF/FTC for 48 weeks as part of a combined biomedical/behavioral intervention offered in a community-based setting serving high-risk youth in an urban setting.
16072070|NCT02367794|Drug|Atezolizumab (MPDL3280A), an engineered anti-programmed death-ligand 1 (anti-PD-L1) antibody|Atezolizumab 1200 milligrams (mg) intravenous infusion (IV) on day 1 of each 21-day cycle.
16072071|NCT02367794|Drug|Carboplatin|Carboplatin area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles.
16072072|NCT02367794|Drug|Nab-Paclitaxel|Nab-paclitaxel 100 milligrams per meter squared (mg/m^2) IV on Day 1, 8, and 15 of each 21-day cycle for 4 or 6 cycles.
16072073|NCT02367794|Drug|Paclitaxel|Paclitaxel 200 mg/m^2 IV on Day 1 of each 21-day cycle for 4 or 6 cycles. Participants of Asian race/ethnicity will be administered paclitaxel 175 mg/m^2 IV.
16072074|NCT02367781|Drug|Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody|"Atezolizumab was administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle. Atezolizumab was administered to participants who were randomized to Arm A (Atezolizumab + Nab-Paclitaxel + Carboplatin) and to participants in Arm B (Nab-Paclitaxel + Carboplatin) who cross over at progression."
16072075|NCT02367781|Drug|Carboplatin|Carboplatin was administered at area under the concentration curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle.
16072076|NCT02367781|Drug|Nab-Paclitaxel|Nab-paclitaxel was administered as IV infusion at a dose of 100 milligrams per square meter (mg/m^2) on Days 1, 8, and 15 of each 21-day cycle.
16072077|NCT02367781|Drug|Pemetrexed|Switch maintenance to pemetrexed can be administered within 6 weeks of Day 1 of the last induction cycle.
16072078|NCT02367755|Drug|Propofol|Propofol use during therapeutic hypothermia
16072079|NCT02367755|Drug|Lorazepam|Lorazepam use during therapeutic hypothermia
16072080|NCT02367742|Behavioral|Endurance Activity (EA)|Subjects have followed a program of endurance activity consisting in a 30 minute walk, 5 times/week. Exercise intensity started from the 60% of the maximum heart rate and raised up to the 75%.
16072081|NCT02367742|Behavioral|EA + Resistance Training (RT)|"Subjects have followed a program combining endurance activity (EA) and resistance training (RT) consisting in a 60 minute work session, 3 times/week consisting in:
~Walk (30 minutes): exercise intensity started from the 60% of the maximum heart rate and raised up to the 75%.
~Musculation (30 minutes): training of the bigger muscle groups (chest, shoulders, arms, abdomen, back, glutei and legs). Exercise intensity started from the 65% of the maximum rated load and raised up to the 75%."
16072082|NCT02367729|Device|Neurostimulator|Non-invasive, battery operated neurostimulator of the external ear worn for 5 days each week x 4 weeks.
16072083|NCT02367729|Device|Sham|Inactive neurostimulator device pre-programmed to be inactive. To be worn for 5 days each week x 4 weeks.
16072084|NCT02367716|Device|CRT|The study will include the Quartet™ family of left heart leads or any newer St. Jude Medical quadripolar CRT systems, including CRT-P systems, that China Food and Drug Administration (CFDA) might approve in the future
16072085|NCT02367703|Procedure|laparoscopic hysterectomy|
16072086|NCT02367690|Drug|Selinexor|Topical gel
16072087|NCT02367690|Other|Standard-of-Care|Surgical debridement, sterile saline rinses, and dressing changes.
16072088|NCT02367690|Other|Vehicle Gel|Topical vehicle gel with no active ingredients.
16072089|NCT02367677|Other|Method comparison|
16072090|NCT02367664|Biological|0.5ml experimental vaccine on day 0,7 Vero cell-derived inactivated Japanese Encephalitis vaccine|Vero cell-derived inactivated Japanese Encephalitis vaccine produced by Shandong Hengye Biotech Co., Ltd./0.5ml, two doses with 7 days interval, a booster dose 12 months after the first dose
16072091|NCT02367664|Biological|0.5ml experimental vaccine on day 0,28 Vero cell-derived inactivated Japanese Encephalitis vaccine|Vero cell-derived inactivated Japanese Encephalitis vaccine produced by Shandong Hengye Biotech Co., Ltd./0.5ml, two doses with 28 days interval, a booster dose 12 months after the first dose
16072092|NCT02367664|Biological|0.5ml active comparator vaccine on day 0,7 inactivated freeze-dried Japanese Encephalitis vaccine(Vero cell)|inactivated freeze-dried Japanese Encephalitis vaccine(Vero cell) produced by Beijing Tiantan Biological Products Co., Ltd. /0.5ml, two doses with 7 days interval, a booster dose 12 months after the first dose
16072093|NCT02367651|Drug|Pazopanib 800 mg|Aqueous film-coated, oval-shaped, white tablets containing either 200 mg or 400 mg pazopanib
16072094|NCT02367651|Drug|Placebo|Tablets matching the 200 mg and 400 mg pazopanib tablets
16072095|NCT02367638|Biological|MG1111|Low, Medium, High Plaque-Forming Unit (PFU) of MG1111 in 0.5 mL dose is administered by subcutaneous injection
16072096|NCT02367638|Biological|VARIVAX|VARIVAX is administered by subcutaneous injection
16072097|NCT02367625|Device|CryoPop|The new CryoPop device will be compared to standard cryotherapy
16072098|NCT02367625|Device|MedGyn MGC 200|Standard cryotherapy
16072099|NCT02367612|Dietary Supplement|Fermented milk|Fermented milk with Lactobacillus paracasei CBA L74
16072100|NCT02367612|Dietary Supplement|Placebo|Maltodextrin
16072101|NCT02367599|Drug|Vitamin D Supplement|Subjects enrolled into this sub-study will be provided Vitamin D 4000IU/day for 24 Weeks.
16072102|NCT02367573|Procedure|2D laparoscopic TAPP inguinal hernia repair|
16072103|NCT02367573|Procedure|3D laparoscopic TAPP inguinal hernia repair|
16072104|NCT02367560|Procedure|Needle decompression|Direct manipulation of calcium deposits in the shoulder with a needle to fragment the deposit performed by a radiologist.
16072105|NCT02367560|Procedure|Shockwave therapy|A physiotherapist performs the shockwave therapy procedure. Treatment is completed in 4 weekly sessions. Treatment involves applying soundwaves directly to the affected shoulder area using an ultrasound device.
16072106|NCT02367560|Drug|Depo medrol|Subacromial steroid injection (40 mg depo medrol) is given to the patient to limit irritation following needle decompression.
16072107|NCT02367560|Device|Ultrasound device|Ultrasound device is applied directly to the shoulder at 0.2 mJ/mm2.
16072108|NCT02367547|Drug|Hexylaminolevulinate cream|The cream is mixed up by the Pharmacy Yliopiston Apteekki for the study and every set is analysed by mass spectrometry.
16072109|NCT02367547|Drug|Aminolevulinic Acid Nano Emulsion|In the study we use Ameluz.
16072110|NCT02367547|Drug|Methylaminolevulinate cream|In the study we use Metvix.
16072174|NCT02367027|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Single dose of 10 mg tablet in fasted conditions.
16072175|NCT02367014|Drug|elamipretide (low dose)|elamipretide (0.01 mg/kg/hr) administered as single day intravenous infusion over 2 hours for 5 days
16072176|NCT02367014|Drug|elamipretide (intermediate dose)|elamipretide (0.10 mg/kg/hr) administered as single day intravenous infusion over 2 hours for 5 days
16072111|NCT02367534|Procedure|umbilical vein catheterization|A 7 cm incision was made in the middle-right of upper abdominal. The umbilical vein was identified located 4cm beyond umbilicus, which was then half dissected transversely and the atresic venous lumen was recanalized with a common duct probe (3mm-5mm, BAKES). A breakthrough feeling would be sensed after approaching forward for 10-14cm and the umbilical vein was successfully recanalized. The common duct probe was pulled out. A catheter (single lumen central venous catheter, 16-20G, TUOREN, China) was then cannulated for 15cm into left branch of portal vein through umbilical vein. The procedure was observed with Doppler ultrasound (LOGIQ S6, GE).
16072112|NCT02367521|Combination Product|Low Frequency Right sided repetitive transcranial magnetic stimulation (LFR rTMS)|"LFR rTMS will be delivered at the Brain Stimulation Program at The Johns Hopkins Hospital with a Magstim Super Rapid 2 stimulator with a focal double 70-mm air cooled coil. LFR rTMS will be administered to the Experimental Group.
~Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength."
16072113|NCT02367521|Device|Sham Comparator: Sham Treatment|Control patients will receive treatment using an identically appearing coil that produces the same sound and is the same weight as the active coil, but has negligible magnetic field strength
16072114|NCT02367508|Behavioral|MODEL Care|The Mindfully Optimizing Delivery of End-of-Life Care (MODEL Care) intervention is two-pronged and mutually interactive with: (1) a patient and family caregiver group, and (2) an oncology provider group. Patients and family caregivers meet as a group for 6 weekly sessions of 2 hours each, for a total of 12 hours of class time. Oncology providers will have 5 class sessions for a total of 16 hours of class time. One class is held conjointly with patients, family caregivers, and providers to practice newly-learned skills. The course curriculum is generally based on mindfulness practices, group discussion, and didactic teaching with an emphasis on embodying interpersonal mindfulness in dialogue in daily life.
16072115|NCT02367495|Device|PCB|PCB with Citrate-based excipient
16072118|NCT02367443|Radiation|Radiation|Radiation: Accelerated Hypofractionated radiotherapy with full dose Chemotherapy
16072119|NCT02367430|Behavioral|Critical Time Intervention With Buried in Treasures included|Critical Time Intervention and BIT Workshop
16072120|NCT02367404|Drug|Duloxetine|Duloxetine 60mg OD for 3 months
16072121|NCT02367404|Behavioral|Pelvic Floor Muscle Training|PMFT weekly for 3 months
16072122|NCT02367391|Behavioral|Motivational Text Messages|Usual care plus motivational text messages sent via Mobile Phone. All participants receive the active medication, Varenicline.
16072123|NCT02367391|Behavioral|Control|Usual Care. All participants receive the active medication, Varenicline.
16072124|NCT02367365|Other|No Intervention|No intervention
16072125|NCT02367365|Other|No Intervention|No intervention
16072126|NCT02367352|Drug|Alisertib|Alisertib tablets
16072127|NCT02367352|Drug|Paclitaxel|Paclitaxel intravenous solution
16072128|NCT02367339|Other|ESBL|Evaluation of the prevalence of ESBL-Enterobacteriaceae colonization among ICU staff
16072129|NCT02367326|Other|data collection|data collection will be carried out by the investigator during a standard hospitalization of the patient
16072130|NCT02367313|Drug|Vapendavir|Vapendavir 264 mg twice daily
16072131|NCT02367313|Drug|Vapendavir|Vapendavir 528 mg twice daily
16072132|NCT02367313|Drug|Placebo|Placebo twice daily
16072133|NCT02367300|Device|BrainScope Ahead 200|A single-use, proprietary headset containing pre-gelled electrodes will be placed on the subject's forehead according to the standard locations of the modified International 10/20 system. Subjects will undergo approximately 5 minutes of eyes closed brain electrical activity recording.
16072134|NCT02367274|Device|BrainScope Ahead 200|A single-use, proprietary headset containing pre-gelled electrodes will be placed on the subject's forehead according to the standard locations of the modified International 10/20 system. Subjects will undergo approximately 5 minutes of eyes closed brain electrical activity recording.
16072135|NCT02367261|Device|SPI implant|SPI implant - the original spiral implant
16072136|NCT02367248|Drug|deferoxamine|Deferoxamine mesylate(40 mg/kg/day up to a maximum daily dose of 6000 mg/day) given by a continuous IV infusion for 5 consecutive days beginning within 12 hours of ICH symptom onset.
16072137|NCT02367248|Drug|Xingnaojing injection|Xingnaojing injection (20 ml/day) given by a continuous IV infusion for 5 consecutive days beginning within 12 hours of ICH symptom onset.
16072138|NCT02367248|Drug|Normal saline|This is a placebo. Normal saline will be given by a continuous IV infusion for 5 consecutive days beginning within 12 hours of ICH symptom onset.
16072139|NCT02367235|Procedure|Traditional vaginal positioning device|A vaginally placed endo-anal sizer will be used to position the vagina during surgery.
16072140|NCT02367235|Procedure|Colpassist vaginal positioning device|A vaginally placed Colpassist will be used to position the vagina during surgery.
16072141|NCT02367222|Other|Exposed to Arepanrix™ Cohort|Demographic characteristics such as age, sex, area of residence, socio-economic status; medical history such as comorbidities, immune status, vaccine indication, receipt of other vaccines or medications and frequency of healthcare contacts, as well as information on pregnancy status and pre-existing conditions will be collected..
16072142|NCT02367222|Other|Unexposed to Arepanrix™ Cohort|Demographic characteristics such as age, sex, area of residence, socio-economic status; medical history such as comorbidities, immune status, vaccine indication, receipt of other vaccines or medications and frequency of healthcare contacts, as well as information on pregnancy status and pre-existing conditions will be collected.
16072143|NCT02367196|Drug|CC-90002|
16072144|NCT02367196|Drug|Rituximab|
16072145|NCT02367183|Drug|GED-0301|
16072146|NCT02367183|Drug|Placebo|
16072177|NCT02367014|Drug|elamipretide (high dose)|elamipretide (0.25 mg/kg/hr) administered as single day intravenous infusion over 2 hours for 5 days
16072178|NCT02367014|Drug|Placebo|placebo (at each dose cohort) administered as single day intravenous infusion over 2 hours for 5 days
16072179|NCT02367001|Other|Normal invitation|No modification and signed by the coordinating doctor as usual
16072352|NCT02365857|Drug|Bupivacaine Only.|Intrathecal injection of Bupivacaine only.
16072147|NCT02367170|Procedure|Bilateral phrenic nerve stimulation and measurement of transdiaphragmatic pressure|Pressure changes are recorded. The phrenic nerves are stimulated with bilateral magnetic stimulators over the neck. Measurements will be performed on day 1, every 7 days after and on last day of participation. The FiO2 will be increased (at least 20%) for at least 2 min. prior to measurement to maintain oxygen saturation >92%. Prior to activating the stimulator, the artificial airway will be occluded with a pneumatic valve to create a quasi-isometric diaphragm contraction. The airway will be occluded for 3 seconds or less for each stimulation. The procedure will be repeated up to a maximum of 5 times per testing day.
16072148|NCT02367170|Drug|Midazolam|In the event a subject shows signs of distress during the Bilateral phrenic nerve stimulation and measurement of transdiaphragmatic pressures, a dose of Midazolam is available. IV (in the vein) dose from 0.5 mg to 2 mg.
16072149|NCT02367170|Procedure|Volitional Measurement of Maximal Inspiratory Pressure (MIP)|MIP is tested on all subjects on day 1, every 7 days after and on the last day of participation. To measure MIP, a subject will be suctioned, disconnected from the ventilator, and instructed to take a few spontaneous breaths. A 1-way exhalation valve connected to a NICO respiratory monitor will be placed on the ET/tracheotomy tube. The subject will be instructed to inhale and exhale as forcefully as possible for 20 seconds, followed by at least 2 minutes of rest on full mechanical ventilation support. MIP trials will be repeated 3 times, and the greatest negative pressure recorded with a NICO respiratory monitor connected to a laptop computer, which will digitize airway pressure, flow and volume signals at 100Hz. This allows for analysis of the individual pressure waves, facilitating pre-post comparisons of MIP at specific time points during inspiration.
16072150|NCT02367170|Device|Inspiratory Muscle Strength Training (IMST)|"Occurs 5 days/wk using threshold IMST device-Respironics model 735. Prior to training, cuff pressure is assessed, FiO2 increased for 2 min. to keep O2 sats ≥92%. The ventilator circuit is disconnected, IMST device is attached to endotracheal or tracheotomy tube and subject is instructed to exhale then forcefully inhale for 10 breaths. The initial setting of device is set to -5cmH2O, subject must generate a negative inspiratory pressure more negative than -5cmH2O to open spring-loaded valve and receive inspiratory airflow. Pressure setting is made more negative/difficult to open by 2-5cm every few breaths until a setting is found where the patient has difficulty fully opening valve, resulting in valve flutter noise. Training pressure is then made more positive /easier by 2-4cm of H2O, so subject can fully open valve, and 4 sets of 6-10 breaths are completed. Training pressures advanced as rapidly as possible, provided the patient is able to open the valve withoutvalve flutternoise."
16072151|NCT02367170|Device|SHAM Inspiratory Muscle Strength Training (IMST)|Training will also be conducted 5 days/wk with an identical IMST device that has been modified by removing the valve leaflet, which essentially removes all inspiratory loading by the device. The modified SHAM IMST device makes a whistling sound during inspiration, which enhances the sham effect. For SHAM treatment, supplemental oxygen FiO2 will be increased for two minute prior to each bout. The ventilator will be disconnected and a SHAM device will be attached to the endotracheal or tracheostomy tube. The subject will be instructed to take 6-10 breaths with a normal tidal volume through the SHAM device and will be reconnected to the ventilator for a 2-minute rest period. The process will be repeated 3 more times for a total of 4 sets of 6-10 breaths.
16072152|NCT02367170|Procedure|Diaphragm thickness measurement|Ultrasound will be used to obtain measurements of the thickness of the right hemidiaphragm. Ultrasonography of the diaphragm will be performed upon enrollment, every 2-4 days during hospitalization and as long as the patient is hospitalized or up to 28 days of participation.
16072153|NCT02367170|Other|Blood and Urine samples|Peripheral blood and urine samples will be collected once upon study entry day (+/- 2 days), once every 2-4 days and once on final day of study participation (+/- 2days).
16072154|NCT02367157|Procedure|Kenzo Kase Method|
16072155|NCT02367157|Device|Kinesio Taping|
16072156|NCT02367131|Drug|Jardiance|Empagliflozin
16072157|NCT02367118|Drug|Prednisone|
16072158|NCT02367118|Drug|Placebo|
16072159|NCT02367105|Drug|Testosterone|Daily testosterone gel applied once daily in the morning to intact skin
16072160|NCT02367105|Other|Lifestyle Therapy|Weekly behavioral diet to induce ~10% weight loss in combination with supervised aerobic and exercise training three times a week
16072161|NCT02367105|Drug|Placebo|Placebo gel for testosterone
16072162|NCT02367092|Behavioral|Exercise Program|They will perform low-intensity, low-resistance exercise facilitated by a DVD video in their home. This exercise program lasts for 30 minutes at a time. Patients will be instructed to engage in this exercise program 3-4 times per week but not more often than 4 times per week. Pre-transplant patients will be asked to do the exercises from enrollment to transplant. Post-transplant patients will be asked to do the exercises for 6 months.
16072163|NCT02367079|Device|Diathermy|Sham diathermy vs switched on diathermy effect on pain where assessed
16072164|NCT02367066|Drug|AR-C165395XX|Oral dose of AR-C165395XX (tablets)
16072165|NCT02367066|Other|Placebo|Oral dose of placebo for AR-C165395XX (tablets)
16072166|NCT02367053|Drug|ZP4207|
16072167|NCT02367053|Drug|Glucagon|
16072168|NCT02367040|Drug|Copanlisib (BAY 80-6946)|Copanlisib is supplied as lyophilized preparation in a 6 mL injection vial. The total amount of copanlisib per vial is 60 mg. The solution for IV infusions is obtained after reconstitution with normal saline solution. Dosing will be administered on Days 1, 8 and 15 of each 28-day cycle. Copanlisib will be administered before rituximab.
16072169|NCT02367040|Drug|Placebo|Placebo is supplied as lyophilized preparation in a 6 mL injection vial. The developed placebo lyophilisate is equivalent to the 60 mg copanlisib formulation, with regard to the composition of excipients and the instructions for reconstitution and dose preparation. Placebo dosing will be administered on Days 1, 8 and 15 of each 28-day cycle. Placebo will be administered before rituximab.
16072170|NCT02367040|Drug|Rituximab|Rituximab dose 375 mg/m2 body surface weekly during Cycle 1 on Days 1, 8, 15 and 22, and then on Day 1 of Cycles 3, 5, 7 and 9.The solution for IV infusions is obtained after reconstitution of a calculated concentration of 1 to 4 mg/ml rituximab into an infusion bag containing sterile, pyrogen-free sodium chloride 9 mg/ml (0.9%) solution for injection or 5% D-Glucose in water.
16072171|NCT02367027|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Single dose of 10 mg oral suspension (dry powder) in fasted conditions.
16072172|NCT02367027|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Single dose of 20 mg oral suspension (dry powder) in fed conditions.
16072254|NCT02366572|Other|Pea fibre + pea starch + pea protein|Pulse extruded cereal
16072180|NCT02367001|Other|revised invitation signed by the coordinating doctor|Invitation with revised text and layout and signed by the coordinating doctor as usual
16072181|NCT02367001|Other|Revised invitation signed by the attending physician|signature typed or typed + handwritten
16072182|NCT02366988|Device|Endoscopic Biliary Stenting|Endoscopic probe self-expandable metallic covered stent Biliary stent will be left in place for 6 months
16072183|NCT02366988|Procedure|Surgical treatment Bilio-enteric anastomosis|Bilio-enteric anastomosis including Whipple, Frey or Beger procedure, double or triple derivation
16072184|NCT02366975|Drug|Testosterone gel 2%|testosterone gel 2% (50mg/die).
16072185|NCT02366975|Other|Placebo|placebo gel
16072186|NCT02366962|Biological|ASP7374|subcutaneous
16072187|NCT02366949|Drug|BAY1217389|"BAY1217389 will be given orally, with a starting dose of 0.25 mg twice daily, on D1, D2, D8, D9, D15 and D16 of a 28 day cycle. BAY1217389 will be dosed in combination with paclitaxel in Arm 1 (Experimental Treatment) and from Cycle 2 onwards in Arm 2 (Standard Treatment).
~After Maximum tolerated dose (MTD) has been defined, expansion cohorts will be conducted at the MTD dose of BAY1217389 and paclitaxel following an intermittent dosing schedule as defined in the dose escalation phase. Up to 12 to 15 breast cancer (triple negative) subjects are planned to be enrolled in the expansion cohort.
~In a higher dose level Cohort 4 > (or equal to) a relative bioavailability assessment of BAY1217389 liquid capsule formulation compared to BAY1217389 oral solution will be performed."
16072188|NCT02366949|Drug|Paclitaxel|Paclitaxel will be given once per week IV at 90 mg/m^2 on D1, D8, and D15 of a 28 day cycle. Paclitaxel will be dosed as a single-agent in Cycle 1 of Arm 2 (Standard Treatment Arm), and in combination with BAY1217389 in Arm 1 (Experimental Treatment Arm) and from Cycle 2 onwards in Arm 2 (Standard Treatment Arm). After Maximum tolerated dose (MTD) has been defined, expansion cohorts will be conducted at the MTD dose of BAY1217389 and paclitaxel following an intermittent dosing schedule as defined in the dose escalation phase. Up to 12 to 15 breast cancer (triple negative) subjects are planned to be enrolled in the expansion cohort.
16072189|NCT02366936|Device|Tortle Midliner|The Tortle Midliner is a breathable, knit beanie with two support rolls to help position the infant's head in midline while supine. It can also be worn sidelying or prone. The design includes Velcro adjustments and tabs for nasal cannula and feeding tubes. It is compatible with some ventilation devices, nasal CPAP, X-ray, and bilirubin shades. The beanie is designed to prevent dolichocephaly and provide passive stretch to cervical rotators if head preference has developed. It comes in three sizes and can fit preemies weighing 500 to 2500 g.
16072190|NCT02366923|Device|stenfilcon A|Each subject randomized to wear either the test or control in either the left of right eye.
16072191|NCT02366923|Device|delefilcon A|Each subject randomized to wear either the test or control in either the left of right eye.
16072192|NCT02366910|Device|omafilcon A|Each subject randomized to wear either the test or control in either the left of right eye.
16072193|NCT02366910|Device|delefilcon A|Each subject randomized to wear either the test or control in either the left of right eye.
16072194|NCT02366897|Device|Manus Sensor Pen|Manus Sensor Pen as made by Manus Neurodynamica Ltd
16072195|NCT02366884|Drug|Anti-Bacterial Agents|Doxycycline, Paramomycin, Clarithromycin, Clindamycin, Dapsone, Miltefosine
16072196|NCT02366884|Drug|Anti-Fungal Agents|Itraconazole, Amphotericin B liposomal, Fluconazole, Terbinafine, Voriconazole
16072197|NCT02366884|Drug|Anti-Protozoal Agents|Nitazoxanide, Chloroquine, Albendazole, Ivermectin, Mebendazole, Metronidazole, Praziquantel, Levamisole
16072198|NCT02366871|Drug|Oral apixaban|To evaluate the incidence of major bleeding (including CRNM bleeding) events in women undergoing surgery for gynecologic cancer with apixaban 2.5 mg BID compared to current standard of care, subcutaneous enoxaparin 40 mg QD for 28 days post surgery.
16072199|NCT02366871|Drug|Subcutaneous enoxaparin|To evaluate the incidence of major bleeding (including CRNM bleeding) events in women undergoing surgery for gynecologic cancer with apixaban 2.5 mg BID compared to current standard of care, subcutaneous enoxaparin 40 mg QD for 28 days post surgery.
16072200|NCT02366858|Procedure|19 gauge|Evaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 19 gauge needle
16072201|NCT02366858|Procedure|22 gauge|Evaluate the ability to perform molecular marker or immunohistochemistry studies on tissue procured with a 22 gauge needle
16072202|NCT02366845|Biological|Fresh Frozen Plasma|An INR dose-response curve with associated transfusion algorithm was generated for plasma in bleeding patients with chronic liver disease. In the intervention arm we will determine the plasma transfusion dose using the algorithm dosing table based on the pre-transfusion INR and the clinician chosen INR target. In the usual care group the dosing will be determined by the clinician.
16072203|NCT02366845|Diagnostic Test|Pre-Transfusion International Normalized Ratio (INR)|INR result prior to Fresh Frozen Plasma (FFP) transfusion determined by clinical lab testing performed within 6 hours to 1 day before transfusion start time.
16072204|NCT02366845|Diagnostic Test|Post-Transfusion International Normalized Ratio (INR)|INR result after Fresh Frozen Plasma (FFP) transfusion completed, determined by clinical lab testing performed within 1 hour after transfusion completed.
16072205|NCT02366832|Procedure|Cryoablation|Subjects who respond to lidocaine nerve block will undergo CT guided cryoablation of the affected nerve stump with a 17g Galil Medical Ice Sphere cryoablation needle.
16072206|NCT02366832|Device|17g Galil Medical Ice Sphere cryoablation needle|Under CT guidance, the corresponding nerve will be targeted with a 17g probe. Two freeze-thaw cycles will be undertaken. The probe will be removed and a final scan obtained.
16072207|NCT02366819|Drug|Oxaliplatin|Given IV
16072208|NCT02366819|Drug|Leucovorin Calcium|Given IV
16072209|NCT02366819|Drug|Irinotecan Hydrochloride|Given IV
16072210|NCT02366819|Drug|Fluorouracil|Given IV
16072211|NCT02366819|Procedure|Conventional Surgery|Undergo surgery
16072212|NCT02366793|Other|Accessory joint mobilization|Three kinds of humeral head slides: anterior, posterior and caudal slides. Subjects remained in supine position during the whole treatment. The techniques were applied in a rhythmical way, with 2 seconds of slide/traction and then a 2-second break. Each technique was carried out for 2 minutes.
16072255|NCT02366559|Device|Hyfrecator|
16072256|NCT02366559|Device|532 nm Q-switched Nd:YAG laser|
16072257|NCT02366546|Drug|TBI-1301|TBI-1301(5*10^8 or 5*10^9) is administered.
16072353|NCT02365831|Other|Observation of treatment management|Group/cohort
16072213|NCT02366793|Other|Nerve mobilization|Neural tissue longitudinal slide using the median neurodynamic test 1 (MNT1) that was described by Butler. The proximal parameters (scapular depression, abduction and humeral external rotation) were introduced with maximum neural tension. On the other hand, the distal parameters (supination, elbow extension, wrist and fingers extension) received the remaining tension that the neural tissue allowed. The parameters were introduced sequentially in the order exposed
16072214|NCT02366780|Procedure|Pump|Breast milk expression using manually or using an electric pump
16072215|NCT02366767|Device|Automatic closed-loop insulin delivery|Sensor transmit glucose data every 5 minutes to the control algorithm which adjusts insulin delivery every 5 minutes.
16072216|NCT02366767|Device|Control|Threshold suspend
16072217|NCT02366754|Device|rTMS|Repetitive TMS is a non-invasive neural stimulation technique achieved via electromagnetic induction. An insulated metal coil is placed on the scalp and short discharges of electric current are directed through the coil producing a magnetic field. This magnetic field is accompanied by an electric field that passes through the skull inducing currents in the tissue beneath the coil. If a cell beneath the coil is viable, then rTMS initiates or inhibits an action potential affecting ongoing neural activity. 30 sessions of active rTMS are provided.
16072218|NCT02366754|Device|Placebo rTMS|The placebo coil simulates magnetic stimulation, but does not actually emit a pulse. The placebo coil looks, sounds and feels like an active rTMS coil. The placebo coil, visually identical to the active coil, provides a slight sensory sensation and discharge noise (i.e., clicking) nearly identical to that of the active coil.
16072219|NCT02366741|Radiation|Whole brain radiotherapy with reduced dose to the hippocampi|VMAT plan to treat the whole brain while reducing the dose to the hippocampi.
16072220|NCT02366728|Biological|Unpulsed DCs|Patients in Group I will receive 1 x 10^6 autologous unpulsed DCs in saline administered to a single side of the groin intradermally 1 day before the fourth vaccine.
16072221|NCT02366728|Biological|Td|Patients in Groups II and III will receive a single dose of Td toxoid (1 flocculation unit, Lf, in 0.4 mLs) administered to a single side of the groin given intradermally 1 day before the fourth vaccine.
16072222|NCT02366728|Biological|Human CMV pp65-LAMP mRNA-pulsed autologous DCs|2x10^7 human CMV pp65-LAMP mRNA-pulsed autologous DCs are given intradermally and bilaterally at the groin site (divided equally to both inguinal regions). Patients will receive up to a total of 10 DC vaccines.
16072223|NCT02366728|Biological|111In-labeled DCs|111In-labeled DCs are 2 x 10^7 pp65-LAMP mRNA loaded mature DCs will be labeled with 111In (50 μCi / 5 x 10^7 DCs) and given i.d. as fourth vaccine for Groups I and II only.
16072224|NCT02366728|Drug|Temozolomide|Temozolomide is a standard chemotherapy given to all enrolled patients at a targeted dose of 150-200mg/m2/d for 5 days every 5 (± 1) weeks for a total of 6 to 12 cycles at the discretion of the treating oncologist.
16072225|NCT02366728|Drug|Saline|0.4mL of saline given in the opposite groin 1 day before the fourth vaccine in all groups
16072226|NCT02366728|Drug|Basiliximab|Group III will receive basiliximab infusions (20 mg I.V) 1 week before the first vaccine and 1 week before the second vaccine.
16072227|NCT02366715|Device|HeatedHumidifiedHighFlowNasalCannula|"We will enroll children 0-2 years old, diagnosed with Bronchiolitis in our ward (Pediatrics C) during the months of November-March 2014-2016. Children will be evaluated according to a Bronchiolitis Severity Score devised by Wang and Co. [3] which was successfully used in previous research. Children answering criteria for moderate or severe Bronchiolitis according to Wang and Co. will be enrolled pending written consent by both parents.
~Our prediction is to enroll a total of 200 children during the 2 winter seasons during 2014-2016."
16072228|NCT02366702|Device|Lower Limb Powered Knee-Ankle Prosthesis|
16072229|NCT02366689|Drug|Triclosan/fluoride toothpaste|Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration).
16072230|NCT02366689|Drug|stannous fluoride toothpaste|Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).
16072231|NCT02366689|Drug|fluoride only toothpaste|Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.
16072232|NCT02366689|Drug|Cetylpyridinium chloride mouthwash|Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds.
16072233|NCT02366689|Drug|Fluoride only mouthwash|Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds.
16072234|NCT02366676|Drug|hyaluronic acid and chondroitin sulphate|IALURIL Intravesical instillation with cystoscope ( 1st month: once a week, 2nd~5th month:once a month)
16072235|NCT02366663|Radiation|90-Yttrium Ibritumomab tiuxetan|0.4 mCi/kg given IV
16072236|NCT02366663|Drug|Carmustine|Given IV
16072237|NCT02366663|Drug|Etoposide|Given IV
16072238|NCT02366663|Drug|Cytarabine|Given IV
16072239|NCT02366663|Drug|Melphalan|Given IV
16072240|NCT02366663|Procedure|Autologous Hematopoietic Stem Cell Transplant|Autologous Hematopoietic Stem Cell Transplantation (ASCT)
16072241|NCT02366663|Biological|Rituximab|Given IV
16072242|NCT02366637|Drug|Placebo|Orally inhaled placebo twice a day (BID) for 4 weeks
16072243|NCT02366637|Drug|PF-03715455|680 micrograms BID, Orally inhaled PF-03715455 for 4 weeks
16072244|NCT02366611|Device|Transcranial Direct Current Stimulation (tDCS)|tDCS is a non-invasive brain neuromodulatory method that involves sending a weak electrical current to the brain. 2mA of tDCS will be applied for 20 minutes at each session and participants will undergo a total of 20 sessions over a 7-week period.
16072245|NCT02366598|Other|Hemp shake|Hemp protein shake
16072246|NCT02366598|Other|Soybean shake|Soybean protein shake
16072247|NCT02366598|Other|Control|Non-protein shake
16072248|NCT02366585|Drug|Ciclosporin|Ciclosporin gel applied to two periodontal pockets
16072249|NCT02366572|Other|Control|Non pulse extruded cereal
16072250|NCT02366572|Other|Pea protein|Pulse extruded cereal
16072251|NCT02366572|Other|Pea starch|Pulse extruded cereal
16072252|NCT02366572|Other|Pea fibre + pea starch|Pulse extruded cereal
16072253|NCT02366572|Other|Pea protein + pea starch|Pulse extruded cereal
16072258|NCT02366546|Drug|Cyclophosphamide|Cyclophosphamide (750mg/m2/day x 2 days Intravenous (IV)) is administered as pre-treatment medication of TBI-1301.
16072259|NCT02366546|Drug|Fludarabine|Fludarabine (20mg/m2 x 5 days Intravenous(IV)) is administered as pre-treatment medication of TBI-1301 in combination with cyclophosphamide.
16072260|NCT02366520|Device|handheld mirror|The child may see the dental treatments that are conducted in his or her mouth by a handheld mirror.
16072261|NCT02366494|Drug|Bicalutamide|ANDROGEN BLOCKADE
16072262|NCT02366494|Drug|Leuprolide|ANDROGEN BLOCKADE
16072263|NCT02366494|Drug|Goserelin|ANDROGEN BLOCKADE
16072264|NCT02366494|Drug|Triptorelin|ANDROGEN BLOCKADE
16072265|NCT02366494|Drug|Docetaxel|Chemo hormonal therapy
16072266|NCT02366494|Drug|Abiraterone|Chemo hormonal therapy
16072267|NCT02366494|Drug|Apalutamide|Nonsteroidal antiandrogen medication
16072268|NCT02366494|Drug|Enzalutamide|Nonsteroidal antiandrogen medication
16072269|NCT02366481|Dietary Supplement|Placebo|Two placebo softgel capsules (containing no vitamin K2) every day for 8 weeks.
16072270|NCT02366481|Dietary Supplement|Low-Dose Vitamin K2 Supplement (menaquinone-7; 90-mcg/d)|One 90-mcg vitamin K2 softgel capsules (containing no vitamin K2) and one placebo softgel capsule everyday for 8 weeks.
16072271|NCT02366481|Dietary Supplement|High-Dose Vitamin K2 Supplement (menaquinone-7; 180-mcg/d)|Two 90-mcg vitamin K2 softgel capsules every day for 8 weeks.
16072272|NCT02366468|Drug|ranibizumab 0.5 mg|intravitreal injection
16072273|NCT02366455|Procedure|Measurement of the length of the right main stem bronchus|Measurement of the length of the right main stem bronchus on CT-Scan
16072274|NCT02366455|Procedure|Measurement of the right upper lobe bronchus antero-posterior angulation|Measurement of the right upper lobe bronchus antero-posterior angulation on CT-Scan
16072275|NCT02366442|Other|Exploring relationships among balance performance, cognitive dysfunction, affective dysregulation, and community integration in Veterans with Traumatic Brain Injury (TBI).|
16072276|NCT02366429|Behavioral|ICBT for antenatal depression|Participants receives active therapist support via the internet to go through a 10-week self-help treatment on a secure web platform
16072277|NCT02366429|Other|TAU|Treatment as usual provided at antenatal clinics and other health care instances
16072278|NCT02366416|Behavioral|Exercise training|Physical activity
16072279|NCT02366403|Behavioral|SKY meditation|SKY (Sudarshan Kriya Yoga) meditation is a standardized, manual-based and replicable program that includes relaxation techniques as well as periods of discussion. The format is a 7-day intensive group class (2 1/2 hours/day intensive format) followed by five weeks of sessions twice per week (1hr/session). SKY meditation incorporates several types of breathing exercises involving arousal and attentional control. Initial breathing exercises are calming and focusing. Subsequent breathing exercises are more fully engaging energizing, allowing the practitioner to focus more fully in each moment.
16072280|NCT02366403|Behavioral|CPT-C|CPT-C (Cognitive Processing Therapy-cognitive only) is a standardized, manual-based treatment consisting of 12, 60-minute sessions which will be given twice per week. Sessions will focusing on specific issues, learning new therapeutic techniques and setting up homework for the following session including real-life application of learned CPT techniques.
16072281|NCT02366390|Behavioral|Psychoeducative intervention|Patient-education about feelings, cognitions, behaviors and bodily sensations related to management of dyspnea and associated anxiety
16072282|NCT02366377|Drug|SHR3824|
16072283|NCT02366377|Drug|Placebo|
16072284|NCT02366377|Drug|Metformin|
16072285|NCT02366364|Drug|Placebo|Single oral administration of placebo consumption on Day 1
16072286|NCT02366364|Drug|NRX-1074 375 mg|Single oral administration of 375 mg consumption on Day 1
16072287|NCT02366364|Drug|NRX-1074 500 mg|Single oral administration of 500 mg consumption on Day 1
16072288|NCT02366364|Drug|NRX-1074 750 mg|Single oral administration of 750 mg consumption on Day 1
16072289|NCT02366351|Drug|SHR3824|Once daily, 12 weeks
16072290|NCT02366351|Drug|Placebo|Once daily, 12 weeks
16072291|NCT02366325|Drug|EPO-018B|
16072292|NCT02366312|Drug|vismodegib|vismodegib is a synthetic, small molecule inhibitor of the sonic Hh pathway, which is involved in tumorigenesis, thus providing a strong rationale for its use in the treatment of a variety of cancers.
16072293|NCT02366299|Drug|Dexmedetomidine|Treatment of delirium by dexmedetomidine i.v. infusion
16072294|NCT02366299|Drug|Propofol|Treatment of delirium by Propofol i.v. infusion
16072295|NCT02366273|Other|PASI and HOMA index|
16072296|NCT02366247|Drug|PEG-Tα1|3.2mg/ml, once a week, taken subcutaneously
16072297|NCT02366247|Drug|Placebo to match PEG-Tα1|1ml, once a week, taken subcutaneously
16072298|NCT02366247|Drug|Adefovir|10 mg, once daily, taken orally for 48 weeks
16072299|NCT02366221|Other|60-minute visit to the outpatient clinic|An interview, an injury-specific physical exam and/or a set of xrays.
16072300|NCT02366221|Other|Phone Interview|If subject cannot return to office in Boston, researcher may conduct interview over the phone.
16072301|NCT02366208|Drug|PEG-Tα1|1.6 mg/ml, once a week, taken subcutaneously
16072302|NCT02366208|Drug|Placebo to match PEG-Tα1|1ml, once a week, taken subcutaneously
16072303|NCT02366208|Drug|Adefovir|10 mg, once daily, taken orally for 48 weeks
16072305|NCT02366169|Device|Medigus Ultrasonic Surgical Endostapler (MUSE) Procedure|The procedure is performed transorally under general anesthesia. The physicians staples the fundus of the stomach to the esophagus approximately 3cm superior to the Z-line in 2 or more locations. The procedural result is anatomically and functionally similar to standard anterior fundoplication (Dor-Thal operation). The staples are standard, 4.8mm titanium surgical staples. Each application of the device fires a quintuplet of staples (5) in three staggered rows. Anti-retching medications at the time of the procedure are essential.
16072306|NCT02366156|Dietary Supplement|Placebo|Three placebo capsules consumed prior to breakfast each day for 4 weeks
16072307|NCT02366156|Dietary Supplement|Low Dose Grape Blend|Three low dose grape blend capsules consumed prior to breakfast each day for 4 weeks.
16072354|NCT02365818|Biological|CG0070|
16072308|NCT02366156|Dietary Supplement|High Dose Grape Blend|Three high dose grape blend capsules consumed prior to breakfast each day for 4 weeks.
16072309|NCT02366143|Drug|Atezolizumab (MPDL3280A), an engineered anti-PD-L1 antibody|Atezolizumab was administered as IV infusion at a dose of 1200 milligrams (mg) on Day 1 of each 21-day cycle until loss of clinical benefit.
16072310|NCT02366143|Drug|Bevacizumab|Bevacizumab was administered as IV infusion at a dose of 15 milligrams per kilogram (mg/kg) on Day 1 of each 21-day cycle until progressive disease, unacceptable toxicity, or death.
16072311|NCT02366143|Drug|Carboplatin|Carboplatin was administered at area under the concentration-time curve (AUC) 6 milligrams per milliliter per minute (mg/mL/min) on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first.
16072312|NCT02366143|Drug|Paclitaxel|Paclitaxel was administered as IV infusion at a dose of 200 milligrams per square meter (mg/m^2) on Day 1 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit whichever occurs first.
16072313|NCT02366130|Drug|Ra-223 dichloride|55 kBq/kg by vein on Day 1 of each 28 day cycle, and then every four weeks thereafter for 6 cycles.
16072314|NCT02366130|Drug|Denosumab|120 mg by subcutaneous (SC) injections on Day 1 of Cycles 2-5.
16072315|NCT02366130|Drug|Hormone Therapy|A single hormonal agent administered daily while on study. Physician to decide what type of hormone therapy participant will receive.
16072316|NCT02366117|Behavioral|Training|Adapted training on the patients active participation, rehabilitation, independence, rights and wellbeing.
16072320|NCT02366078|Behavioral|SMART|Paced breathing meditation with cognitive training
16072321|NCT02366065|Drug|Acetaminophen|Before treatment, study subjects will have their intraocular pressure measured at 8 am, 10 am, 12 pm and 4 pm. They will then take acetaminophen 650 mg qid for 7 days and the intraocular pressures again measured at 8 am, 10 am, 12 pm, and 4 pm. Subjects will then stop the acetaminophen and return one week later for one more set of intraocular pressure measurements at 8 am, 10 am, 12 pm, and 4 pm.
16072322|NCT02366052|Behavioral|Nutritional Counseling|Nutritional counseling by a trained nutritionist for 12 weeks.
16072323|NCT02366052|Dietary Supplement|Lactobacillus casei shirota (LCS)|The dietary supplement LCS (Yakult plus) will be given 2 times a day for 12 weeks in addition to dietary counseling every 3 weeks.
16072324|NCT02366052|Other|Nutritional Counseling and LCS|Nutritional counseling by a trained nutritionist in addition to the dietary supplement LCS (2 times a day) for 12 weeks.
16072325|NCT02366026|Biological|IR103|REMUNE HIV/AIDS Vaccine with two adjuvants IFA + Amplivax
16072326|NCT02366013|Biological|rcAd26.MOS1.HIV-Env 1x10^8 vp|1 oral capsule, 1x10^8 vp/capsule or 1 placebo capsule; 5:1 vaccine:placebo
16072327|NCT02366013|Biological|rcAd26.MOS1.HIV-Env 1x10^9 vp|10 oral capsules, 1x10^8 vp/capsule or 10 placebo capsules; 5:1 vaccine:placebo
16072328|NCT02366013|Biological|rcAd26.MOS1.HIV-Env 1x10^10 vp|1 oral capsule, 1x10^10 vp/capsule or 1 placebo capsule; 5:1 vaccine:placebo
16072329|NCT02366013|Biological|rcAd26.MOS1.HIV-Env 1x10^11 vp|10 oral capsules, 1x10^10 vp/capsule or 10 placebo capsules; 5:1 vaccine:placebo
16072330|NCT02366000|Other|Brief Parental Training Intervention|The workshop was designed to assist parents to communicate with their children about issues in the prevention of health risk behaviours- alcohol, tobacco and other drug use (ATOD), by equipping them with the appropriate interaction skills and encouraging them to build relationships with their children.
16072331|NCT02365987|Dietary Supplement|Interesterified blend of palm kernal and plam stearin|50g fat provided as interesterified palm kernal and palm sterin blend in a single meal
16072332|NCT02365987|Dietary Supplement|Un-interesterified blend of palm kernal and plam stearin|50g fat provided as un-interesterified palm kernal and palm sterin blend in a single meal
16072333|NCT02365974|Device|Transcutaneous Electrical Stimulation|TENS will be applied in the cervicothoracic ganglion region located between the C7 and T4 vertebral processes for 40 minutes three times weekly for a total of four weeks. The intensity in milliamps will be adjusted depending on the sensitivity of each individual patient.
16072334|NCT02365974|Device|No Transcutaneous Electrical Stimulation|The sham group will be submitted to the procedure to fit the stimulation equipment. without be submitted to stimulation.
16072335|NCT02365961|Drug|ropivicaine|
16072336|NCT02365961|Drug|clonidine|
16072337|NCT02365961|Drug|Epinephrine|
16072338|NCT02365961|Drug|Noropin|
16072339|NCT02365948|Biological|Certolizumab Pegol|"Active Substance: Certolizumab Pegol
~Pharmaceutical Form: Prefilled syringes
~Concentration: 200 mg/mL
~Route of Administration: Subcutaneous injection"
16072340|NCT02365948|Other|Placebo|"Active Substance: Placebo
~Pharmaceutical Form: Prefilled syringes
~Concentration: 0.9 % Saline
~Route of Administration: Subcutaneous injection"
16072341|NCT02365935|Procedure|Group A adjuvant chemotherapy|In Group A, all patients received 4 cycles of adjuvant chemotherapy every three weeks according to the scheme Cisplatin 100 mg/mq and Paclitaxel 175 mg/mq.
16072342|NCT02365935|Procedure|Group B adjuvant chemotherapy|In Group B, all patients received 6 cycles of adjuvant chemotherapy every three weeks according to the scheme Cisplatin 100 mg/mq and Paclitaxel 175 mg/mq.
16072343|NCT02365935|Drug|Cisplatin|
16072344|NCT02365935|Drug|Paclitaxel|
16072345|NCT02365909|Drug|0.5% bupivacaine|This group will receive 0.3 ml of 0.5% bupivacaine per nare, applied with the Tx360®
16072346|NCT02365909|Drug|normal saline|This group will receive 0.3 ml of normal saline per nare, applied with the Tx360®
16072347|NCT02365896|Procedure|TLDG or LADG|
16072348|NCT02365883|Device|Photoacoustic Imaging System|manufactured by Endra
16072349|NCT02365870|Drug|rotigotine transdermal patch|Participants will receive the dopamine agonist rotigotine in the form of a transdermal patch to be worn daily
16072350|NCT02365870|Drug|placebo|Participants will receive a placebo transdermal patch to be worn daily
16072351|NCT02365857|Drug|Dexmedetomidine & Bupivacaine.|Intrathecal injection of Dexmedetomidine & Bupivacaine.
16072355|NCT02365805|Drug|Epirubicin + Ciclofosfamide + Fluorouracil + Paclitaxel|Epirubicin 90 mg/m2 + Ciclofosfamide 600 mg/m2 + 5-Fluorouracil 600 mg/m2 intravenous infusion on day 1 every three weeks, for four cycles; followed by Paclitaxel 100 mg/m2 weekly for eight weeks.
16072356|NCT02365805|Drug|Epirubicin + Cisplatin + Fluorouracil|Epirubicin 60 mg/m2 + Cisplatin 60 mg/m2 intravenous infusion on day 1 every three weeks and 5-Fluorouracil 200 mg/m2/day for eight cycles.
16072357|NCT02365805|Drug|Docetaxel + Ciclofosfamide|Docetaxel 75 mg/m2 + Ciclofosfamide 600 mg/m2, intravenous infusion on day 1 every three weeks, for eight cycles.
16072358|NCT02365792|Procedure|Clinical Decision Support Tool for Prehospital Care|"A clinical decision support system (CDSS) is a health information technology system that is designed to assist physicians and other health professionals with clinical decision-making tasks. A working definition of the Centre for Health Evidence: Clinical Decision Support systems link health observations with health knowledge to influence health choices by clinicians for improved health care."
16072359|NCT02365779|Procedure|bilateral laparoscopic salpingectomy|Use of the confocal laser endomicroscopy Cellvizio® system during laparoscopy salpingectomy
16072360|NCT02365779|Device|endomicroscopy Cellvizio® system|
16072361|NCT02365766|Drug|Pembrolizumab|In this dose-finding cohort, pembrolizumab (MK-3475) will be administered (cisplatin-eligible patients only) at starting dose 200mg IV every 21 days for 4 cycles to determine RP2D. Once MTD is established in phase Ib, pembrolizumab will be administered on phase II cohorts I and II at RP2D every 21 days for 5 cycles.
16072362|NCT02365766|Drug|Gemcitabine|For cisplatin-eligible patients on phase Ib and phase II cohort 1, gemcitabine 1000mg/m2 IV, D1 and D8 every 21 days for 4 cycles. For cisplatin-ineligible patients on phase II cohort II, gemcitabine 1000mg/m2 will be administered D1, D8 and D15 every 28 days for 3 cycles.
16072363|NCT02365766|Drug|Cisplatin|For cisplatin-eligible patients, cisplatin 70mg/m2 IV will be administered D1 every 21 days for 4 cycles.
16072364|NCT02365766|Procedure|Consolidative Surgery|Following completion of treatment, subjects will then have surgery to remove their primary tumor within 2-7 weeks after their last dose of neoadjuvant therapy.
16072365|NCT02365753|Device|SofPulse|Pulsed Electomagnetic Field Therapy Device placed over incision and turned on and kept in place with tape.
16072366|NCT02365740|Other|gastric emptying test|gastric emptying rate for solid will be determined using the 13C-OBT. Breath samples will be taken before the meal and then at 15-min intervals for a period of 240 min postprandially. The 13C content will be determined by on-line gas chromatographic purification-isotope ratio mass spectrometry (ABCA; Europe Scientific, Crewe, UK). The 13CO2 excretion curves will be analyzed and the half-emptying time (t½) and lag phase (tlag) calculated.
16072367|NCT02365740|Other|gut hormones determination|blood sampling at 0, 15, 30, 60, 90, 120, 180 min for determination of plasma, glucagon and GI hormones (Ghrelin, GLP-1, GIP)
16072368|NCT02365740|Other|Continuous Glucose Monitoring|7 days Continuous Glucose Monitoring
16072369|NCT02365740|Drug|Insulin single bolus|pre-prandial insulin administered as single bolus calculated on the basis of carbohydrate counting and each patient's insulin/glycaemic load
16072370|NCT02365740|Drug|Insulin double-wave bolus|pre-prandial insulin fractioned into a double-wave bolus
16072371|NCT02365727|Drug|Liposomal bupivacaine|
16072372|NCT02365727|Drug|Ropivacaine|
16072373|NCT02365727|Drug|Epinephrine|
16072374|NCT02365727|Drug|Clonidine|
16072375|NCT02365727|Drug|Saline|
16072376|NCT02365714|Radiation|CK Stereotactic Accelerated Partial Breast Irradiation|Adjuvant radiation therapy will be delivered to the region of the lumpectomy cavity once daily for 5 treatments over 5-10 days.
16072377|NCT02365701|Drug|Motilitone 30mg|30mg of Motilitone in tablet form, to be taken 3 times daily for 4 weeks
16072378|NCT02365701|Drug|Placebo|Placebo, in tablet form, to be taken 3 times daily for 4 weeks. The placebo is the same formulation as Motilitone except that it does not contain the active pharmaceutical ingredient.
16072379|NCT02365688|Procedure|Initial bolus pre-incision|Measured hemodynamic response to pre-incision bolus
16072380|NCT02365675|Device|Cotton gauze with petrolatum|
16072381|NCT02365675|Device|Cellulose acetate with petrolatum|
16072382|NCT02365675|Device|Nanocrystalline silver (Acticoat)|
16072383|NCT02365675|Device|Carboxymethylcellulose with ionic silver (Aquacel Ag)|
16072384|NCT02365662|Drug|ABBV-221|ABBV-221 will be given either every 3 weeks or 2 weeks on, 1 week off or weekly dosing by intravenous infusion approximately over 30 minutes to 3 hours. This is a dose escalation study, therefore the dose of ABBV-221 will change throughout the study.
16072385|NCT02365649|Drug|Placebo|Oral Dosing
16072386|NCT02365649|Drug|ABT-494|Oral Dosing
16072387|NCT02365636|Drug|TV-45070|TV-45070 is an ointment applied topically twice daily to area of pain.
16072388|NCT02365636|Drug|Placebo|The matching placebo ointment contained only the excipients of the active treatment; also applied topically twice daily to area of pain.
16072389|NCT02365623|Drug|TMC207 (bedaquiline)|TMC207 (bedaquiline): Participants will receive TMC207 (bedaquiline) 400 milligram (mg) as 4*100 mg tablets once daily 2 weeks (14 days) followed by 200 mg (2 tablets) 3 times a week up to Week 24 along with background regimen (BR). Based on the discussion with the Pharmaceuticals and Medical Devices Agency (PMDA), the extension of 24-week TMC207 treatment with BR drugs may occur up to Week 48, under certain circumstances, such that many BR drugs which are susceptible at the beginning of the Treatment Phase show resistance during the Treatment Phase.
16072390|NCT02365623|Drug|Background Regimen (BR)|Participants will receive anti-bacterial tuberculosis drugs (pyrazinamide [PZA], ethambutol [EB, EMB], streptomycin [SM], kanamycin [KM, KAN], enviomycin [EVM], ethionamide [TH], cycloserine [CS], para-aminosalicylic acid [PAS], amikacin [AMK], levofloxacin [LVFX] and other fluoroquinolone. Other drugs are used less commonly, such as amoxicillin-clavulanate, linezolid and clofazimine based on Investigator's decision twice a week from Day 1 up to 78 weeks after conversion or 102 weeks after day 1 (what happens first).
16072391|NCT02365610|Drug|GWP42006|
16072392|NCT02365610|Drug|Placebo Control|
16072393|NCT02365597|Drug|Erdafitinib|8 mg orally once daily for 28 days on a 28 day cycle.
16072394|NCT02365597|Drug|Midazolam|Participants who enrolled in DDI substudy will receive pretreatment with single dose of midazolam on Day -2 and single dose of midazolam on Day 13.
16072909|NCT02361645|Drug|Nepafenac 0.1% eyedrops|
16072395|NCT02365597|Drug|Metformin|Participants who enrolled in DDI substudy will receive pretreatment with single dose of metformin on Day -1 and single dose of metformin on Day 14.
16072396|NCT02365584|Drug|lanreotide (Autogel formulation)|Lanreotide Autogel 120 mg by deep subcutaneous route, at the maximal scheduled standard dose of 120 mg/28 days, just for 1 administration.
16072397|NCT02365571|Drug|LY3154207|Administered orally
16072398|NCT02365571|Drug|Placebo|Administered orally
16072399|NCT02365571|Drug|Itraconazole|Administered orally (twice daily on Day 3 and then once daily to Day 12) as a 10 mg/mL solution
16072400|NCT02365558|Drug|Evacetrapib|Administered orally
16072401|NCT02365558|Drug|Omeprazole|Administered orally
16072402|NCT02365532|Drug|GS-6615|GS-6615 tablets administered orally
16072403|NCT02365532|Drug|Placebo to match GS-6615|Placebo to match GS-6615 tablets administered orally
16072404|NCT02365532|Drug|Placebo to match dofetilide|Placebo to match dofetilide capsules administered orally
16072405|NCT02365532|Drug|Dofetilide|Dofetilide 500 μg capsules administered orally according to the current prescribing information
16072406|NCT02365519|Biological|LME636 ophthalmic solution|
16072407|NCT02365519|Biological|LME636 Vehicle|Inactive ingredients used as a placebo comparator
16072408|NCT02365506|Drug|Eleclazine|Tablets administered orally in a single dose
16072409|NCT02365506|Drug|Placebo|Placebo to match tablets administered orally in a single dose
16072410|NCT02365493|Drug|Beta-Lactam|
16072411|NCT02365480|Drug|Berberine Chloride|Given PO
16072412|NCT02365480|Other|Laboratory Biomarker Analysis|Correlative studies
16072413|NCT02365480|Other|Placebo Administration|Given PO
16072414|NCT02365454|Device|Stent Graft Placement (Nexus)|"The Nexus stent graft is introduced through a groin to the diseased location at the Aortic Arch. Depending on the patients anatomy and other medical considerations the physician may decide that blood flow to the sub-clavian artery and possibly also to the left carotid artery is required to be maintained via surgical bypass grafting, either immediately, or a few days, before the implantation. In addition to the incision for introducing the investigational stent graft, two smaller access sites are required, one at the groin on the opposite side and on into the Right Arm to the Brachial Artery.
~This endovascular procedure will likely require full anesthesia. The entire procedure is assisted by an angiography imaging system."
16072415|NCT02365441|Drug|Regorafenib|
16072416|NCT02365441|Drug|imatinib|
16072417|NCT02365428|Behavioral|Physical activity text messages|
16072418|NCT02365415|Drug|Sirolimus|8 weeks oral sirolimus, following drug levels
16072419|NCT02365402|Drug|Entecavir|After enrolled, entecavir will added, and patients will receive treatment of PEG-IFN a-2a combine with entecavir for 48 weeks and 24 weeks of follow-up after treatment.
16072420|NCT02365389|Drug|MTZ vaginal gel|MTZ vaginal gel once daily for 5 days
16072421|NCT02365389|Drug|Conventional MTZ vaginal gel|Conventional MTZ vaginal gel (Tricho gel 0.8%, Sedico, Egypt) twice daily for 5 days
16072422|NCT02365363|Other|Control|Non pulse ingredient bagel
16072423|NCT02365363|Other|Pea flour|Pulse ingredient bagel
16072424|NCT02365363|Other|Pea fibre|Pulse ingredient bagel
16072425|NCT02365363|Other|Pea flour and pea fibre|Pulse ingredient bagel
16072426|NCT02365363|Other|Pea flour and pea protein|Pulse ingredient bagel
16072427|NCT02365363|Other|Pea flour + pea fibre + pea protein|Pulse ingredient bagel
16072428|NCT02365350|Procedure|STEINER-TAN Needle®|A purpose built new double lumen needle with little dead space.
16072429|NCT02365350|Procedure|17 G single lumen needle|A conventional single lumen IVF aspiration needle.
16072430|NCT02365324|Behavioral|Peer-Education Family Fitness Program (PE-FFP)|The proposed integrated project will be implemented by peers and will evaluate the effects of an evidence-based extension education program, grounded in Stages of Change Learning Theory and guided by Social Cognitive Theory (SCT), having 2 arms for the study (with and without a peer-education mode of delivery) on balancing calories to manage body weight (BW), reducing certain foods and food components, increasing selected foods and nutrients, building healthy eating patterns [i.e., fundamental principles of the Dietary Guidelines for Americans (DGAs), 2010] and SCT variables.
16072431|NCT02365324|Behavioral|Family Fitness Program (FFP)|The proposed integrated project will be implemented by adults and will evaluate the effects of an evidence-based extension education program, grounded in Stages of Change Learning Theory and guided by Social Cognitive Theory (SCT), having 2 arms for the study (with and without a peer-education mode of delivery) on balancing calories to manage body weight (BW), reducing certain foods and food components, increasing selected foods and nutrients, building healthy eating patterns [i.e., fundamental principles of the Dietary Guidelines for Americans (DGAs), 2010] and SCT variables.
16072432|NCT02365311|Procedure|transesophageal echocardiography(TEE)|Transesophageal echocardiography examination will be performed TLV in supine and lateral position, 10, 20 and 30 min during OLV in left lateral decubitus position. By using the transesophageal echocardiography, we will evaluate the changes of pulmonary blood flow and cardiac function.
16072433|NCT02365298|Device|etafilcon A|etafilcon A soft contact lens
16072434|NCT02365298|Device|nelfilcon A|nelfilcon A
16072435|NCT02365285|Drug|Galantamine|16 mg po prior to the infusion of intralipid
16072436|NCT02365285|Drug|Placebo Oral Capsule|Placebo oral capsule prior to the infusion of intralipid/heparin
16072437|NCT02365285|Drug|Intralipid|Intralipid 20% will be infused at 0.8 mL/m2/min for 4h after oral placebo or Galantamine
16072438|NCT02365285|Drug|Heparin|heparin bolus of 1000 U will be followed by 200 U/h infusion for 4h after oral placebo or Galantamine
16072439|NCT02365272|Drug|Amikacin|Amikacin administered in a single dose for critical care patients
16072440|NCT02365259|Device|Phototherapy|Participants will be exposed to phototherapy according to the 2014 Guidelines issued by the American Academy of Dermatology 3 days per week over an 8-week period.
16072441|NCT02365246|Device|immunoadsorptions with an IgE-specific adsorption column|immunoadsorptions
16072442|NCT02365233|Drug|DPP4 inhibitor|Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.
16072552|NCT02364557|Radiation|Stereotactic Radiosurgery|Undergo stereotactic radiosurgery
16072443|NCT02365233|Drug|Pioglitazone|Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.
16072444|NCT02365233|Drug|Lantus insulin|Comparison between three common alternative therapeutic strategies to improve glycemic control in patients with type 2 diabetes who are not controlled with metformin alone.
16072445|NCT02365220|Behavioral|No expectancy (control)|No expectancy instruction with regard to the efficacy of the daily smartphone-based training (exposition to either mock sound or color)
16072446|NCT02365220|Behavioral|Prospective expectancy|"Prospective expectancy instruction (Training will have an effect on...) with regard to the efficacy of the daily smartphone-based training (exposition to either mock sound or color)"
16072447|NCT02365220|Behavioral|Retrospective expectancy|"Retrospective expectancy instruction (Training already had an effect on...) with regard to the efficacy of the daily smartphone-based training (exposition to either mock sound or color)"
16072448|NCT02365220|Behavioral|Prospective and retrospective expectancy|"Prospective (Training will have an effect on...) and retrospective (Training already had an effect on...) expectancy instruction with regard to the efficacy of the daily smartphone-based training (exposition to either mock sound or color)"
16072449|NCT02365207|Drug|BCG strain of Mycobacterium bovis|Invasive bladder cancer treated with 3-6 weeks of intravesical BCG
16072450|NCT02365194|Behavioral|Prehabilitation|information included in arm description
16072451|NCT02365194|Behavioral|Standard counseling|information included in arm description
16072452|NCT02365181|Procedure|intra-articular local anesthetic infiltration|intra-articular local anesthetic infiltration with 20 ml of Ropivacaine 2 % and catheter
16072453|NCT02365181|Procedure|inter-scalene block|inter-scalene block with 20 ml of Ropivacaine 2 % and catheter
16072454|NCT02365181|Drug|Ropivacaine 2 %|20 ml of Ropivacaine 2 %
16072455|NCT02365168|Other|Cod_Double Blind Placebo Controlled Food Challenge|DBPCFC Food Challenge with cod in the following doses: 3µg, 600µg, 12 mg, 120 mg, and 1g covered in chocholate dessert over one day
16072456|NCT02365168|Other|Salmon_Double Blind Placebo Controlled Food Challenge|DBPCFC Food Challenge with salmon in the following doses: 3µg, 600µg, 12 mg, 120 mg, and 1g covered in chocholate dessert over one day
16072457|NCT02365168|Other|Mackerel_Double Blind Placebo Controlled Food Challenge|DBPCFC Food Challenge with mackerel in the following doses: 3µg, 600µg, 12 mg, 120 mg, and 1g covered in chocholate dessert over one day
16072458|NCT02365168|Other|Placebo_Double Blind Placebo Controlled Food Challenge|DBPCFC Food Challenge with placebo covered in chocholate dessert over one day
16072459|NCT02365155|Other|Multicomponent training intervention.|The intervention group will be included in a program specifically developed for this study based on the multidimensional continuous care of patients with heart failure and frailty diagnosis or prefrailty. A joint interdisciplinary nursing intervention including a physical part (endurance, strength, flexibility and balance).
16072460|NCT02365155|Other|Nutrition intervention|Both groups will be included in a program of quarterly monitoring receiving nutritional support: nutritional advice plus enteral supplementation should specify.
16072461|NCT02365155|Other|Cognitive intervention|Both groups will be included in a program of quarterly monitoring receiving cognitive support: detection and treatment of depression and delirium in medical consultation.
16072462|NCT02365155|Other|D-vitamin intervention|Both groups will be included in a program of quarterly monitoring receiving hormonal support: supplementation of vitamin D if required with adjustment for guides.
16072463|NCT02365155|Other|Occupational intervention|The intervention group will be included in a program specifically developed for this study based on the multidimensional continuous care of patients with heart failure and frailty diagnosis or prefrailty. A joint interdisciplinary nursing intervention including occupational support.
16072464|NCT02365155|Other|Heart failure follow up.|Both groups will be included in a program specifically developed for this study based on the multidimensional continuous care of patients with heart failure and frailty diagnosis or prefrailty. A joint interdisciplinary medical intervention including and pharmacological treatment of heart failure and comorbidities adjusted according to recent clinical guidelines requirements.
16072465|NCT02365142|Biological|100 million Bone marrow mesenchimal stem cells|100 million Bone marrow mesenchimal stem cells with PRGF
16072466|NCT02365142|Biological|Platelet Rich plasma (PRGF)|3 injections of PRGF
16072467|NCT02365129|Other|Exercise training based on recommendations for adults (WHO)|The length of the trial will be 6 months. the total time of aerobic exercise in both moderate-intensity and vigorous-intensity groups will be 150 minutes/week, whereas the time needed to complete the resistance training exercises will be ≈15-30 minutes for both groups.
16072468|NCT02365116|Behavioral|Peer mentorship|Patients who are working with a peer specialist will have their sessions audio taped and reviewed by research staff for training purposes and to ensure that peer specialists are following protocol.
16072469|NCT02365116|Behavioral|Enhanced Usual Care|The enhancement to usual care will occur at the 3 and 6 month follow-up assessments, where participants will be assessed to determine whether they require any additional referral information for follow-up care. If referral information is indicated, the patient will be provided a list of mental health treatment providers in their area.
16072470|NCT02365103|Other|Test meal I (given with water)|4 mg of the iron stable isotope, in a form of ferrous sulphate solution, extrinsically labelled in the test meal administered in the study, enrichment in the system will take approximately 14 days post dosing
16072471|NCT02365103|Other|Test meal II (simultaneously with tea)|4 mg of the iron stable isotope, in a form of ferrous sulphate solution, extrinsically labelled in the test meal administered in the study, enrichment in the system will take approximately 14 days post dosing
16072472|NCT02365103|Other|Test meal III (1 hour after test meal)|4 mg of the iron stable isotope, in a form of ferrous sulphate solution, extrinsically labelled in the test meal administered in the study, enrichment in the system will take approximately 14 days post dosing
16072473|NCT02365103|Other|Reference iron dose|3 mg of the iron stable isotope, in a form of ferrous sulphate solution, extrinsically labelled and administered in the study, enrichment in the system will take approximately 14 days post dosing
16072474|NCT02365090|Other|patching|covering the sound eye with a patch to force use of the amblyopic eye
16072553|NCT02364557|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16072475|NCT02365090|Other|binocular games|playing iPad games 1 hour per day 5 days per week to allow the child to use the amblyopic eye and the sound eye together
16072476|NCT02365064|Device|AirCurve 10 ASV|Device is able to provide both ASV therapy and CPAP therapy modes.
16072477|NCT02365051|Behavioral|Care of Persons with Dementia in their Environments|In-home visits by occupational therapist and advanced practice nurse.
16072478|NCT02365038|Other|Driving pressure limited ventilation|We will use volume controlled ventilation or pressure support in the weaning phase. We will adjust tidal volume between 3 and 8 mL/Kg of predicted body weight in order to achieve a driving pressure of 13 cmH2O. The respiratory rate will be titrated to achieve a pH between 7.30 and 7.45 (maximum respiratory rate is 50 breathings per minute). We will not limit plateau pressure in this arm.
16072479|NCT02365038|Other|Conventional ventilation|ARDSNet Strategy: conventional mechanical ventilation strategy with tidal volume between 4 and 6 mL/kg of predicted body weight and plateau pressure limited to 30 cmH2O.
16072480|NCT02365025|Other|Meetings guides by experts in sleeping disorders.|meetings guides by experts in sleeping disorders. In those meeting the parents will be exposed to sleep disturbances, the importance of sleep habits and the influence of electronic media on sleep and learning.
16072481|NCT02365012|Drug|Midodrine|Crossover intervention comparing midodrine to placebo for subjects with orthostatic intolerance
16072482|NCT02364999|Drug|Bevacizumab-Pfizer|Bevacizumab-Pfizer: 15 mg/kg IV on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles, followed by the assigned blinded bevacizumab monotherapy.
16072483|NCT02364999|Drug|Bevacizumab-EU|bevacizumab-EU: 15 mg/kg IV on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles followed by the assigned blinded bevacizumab monotherapy.
16072484|NCT02364999|Drug|Paclitaxel|Paclitaxel 200 mg/m2 via IV infusions on Day 1 of a 21-day cycle for each of at least 4 and no more than six (6) 21-day cycles.
16072485|NCT02364999|Drug|Carboplatin|carboplatin AUC =6.0 via IV infusions on Day 1 of a 21-day cyclefor each of at least 4 and no more than six (6) 21-day cycles.
16072486|NCT02364986|Drug|Rebif®|Rebif® 44µg (day 1, 3, 5 and 8) s.c.
16072487|NCT02364986|Drug|Avonex|Avonex 30µg (day 1 and 8) i.m.
16072488|NCT02364973|Other|PET-MRI|The study patients undergo positron emission tomography (PET) after informed consent is obtained
16072489|NCT02364947|Drug|Nalmefene hydrochloride|As-needed; tablets, orally
16072490|NCT02364947|Drug|Placebo|As-needed; tablets, orally
16072491|NCT02364934|Drug|Propofol|This study was designed to determine the dose requirements for rocuronium, administered by continuous infusion to maintain a stable 90-99% T1 depression (depression of the first twitch in the train-of-four, TOF) in adult, elderly and different sex patients under sufentanil and propoful anaesthesia.
16072492|NCT02364934|Drug|Sevoflurane|This study was designed to determine the dose requirements for rocuronium, administered by continuous infusion to maintain a stable 90-99% T1 depression (depression of the first twitch in the train-of-four, TOF) in adult, elderly and different sex patients under sufentanil and sevoflurane anaesthesia.
16072493|NCT02364921|Device|Two multilayer compression bandage|"Usual clinical practice in venous ulcer in wound care in assessing, cleaning, desinfection, debridement and topical treatment.
~Compression therapy: a multilayer compression bandage with two layers, suitable for the treatment of venous leg ulcers and to reduce edema chronic venous be used. Apply one two seven days"
16072494|NCT02364921|Device|Crepe bandage|Crepe bandage: Usual clinical practice in venous ulcer in wound care. crepe bandage apply one to seven days
16072495|NCT02364908|Other|therapeutic education|This is the group sessions aimed to convey additional information to patients about their disease. The main objective is to learn how to better anticipate any medical problems and better manage daily life with the disease.
16072496|NCT02364895|Other|Males control group: Deferred letter|This letter will be sent 6 months after index (mailing) date
16072497|NCT02364895|Other|Males Group 1: Current CCC invitation letter|This letter is currently used by the program in 50-54 year olds
16072498|NCT02364895|Other|Males Group 2: New letter with neutral gender content|Unisex letter
16072499|NCT02364895|Other|Males Group 3: New letter with male-specific content|New letter tailored for men
16072500|NCT02364895|Other|Females control group: Deferred letter|This letter will be sent 6 months after index (mailing) date
16072501|NCT02364895|Other|Females Group 1: Current CCC invitation letter|This letter is currently used by the program in 50-54 year olds
16072502|NCT02364895|Other|Females Group 2: New letter with neutral gender content|Unisex letter
16072503|NCT02364882|Drug|Sildenafil|
16072504|NCT02364869|Dietary Supplement|Fructooligosaccharide|Patients will be evaluated at baseline, week 6 and 12.
16072505|NCT02364869|Dietary Supplement|Maltodextrin|Placebo Comparator. Patients will be evaluated at baseline, week 6 and 12.
16072506|NCT02364856|Device|Analgesia Nociception Index|"The Analgesia Nociception Index (ANI, MDoloris Medical Systems, Lille, France), based on Heart Rate Variability analysis, measures continuously and non-invasively the influence of Respiratory Sinus Arrhythmia on the heart rate. This 0-100 index indicates the proportion of paraS over sympathetic activity. In adults during surgery under general anesthesia, ANI decreases after painful stimulation and has been related to the balance between analgesia and nociception.
~ANI is calculated from heart rate recording."
16072507|NCT02364843|Dietary Supplement|Amino Acid: Threonine|Each of the 18 infants will have a different intake of dietary amino acid threonine for a 24 period and by cross-over regression analysis a break-point or requirement will be established
16072508|NCT02364830|Drug|Anise-oil EC Capsule|Anise-oil EC Capsule,One Cap(187mg)/day for 4 Weeks
16072509|NCT02364830|Other|Placebo|One Placebo Capsule/Day for 4 Weeks
16072510|NCT02364830|Drug|Colpermin®|Colpermin® Capsule/Day for 4 Weeks
16072554|NCT02364544|Behavioral|Relapse Prevention Plan|brief, in-person, relapse prevention counseling with supplemental web-based learning modules,
16072555|NCT02364544|Behavioral|Daily Support Website|web-based program for patients and families that provides psychoeducation about schizophrenia and its treatments to improve knowledge, increase problem-solving skills and offer social support through the use of web-based therapist facilitated sessions
16072598|NCT02364232|Behavioral|bilateral training with and without mirror feedback|
16072706|NCT02363335|Drug|Roflumilast/Sitagliptin|Both Roflumilast and Sitagliptin together
16072511|NCT02364817|Behavioral|cognitive and psychiatric assessment|"Administered at baseline:
~Clinical Institute Withdrawal Assessment for Alcohol (CIWA-Ar)
~hyperactivity : Adult ADHD Self-Report Scale (ASRS), Wenders-Utah Rating Scale (WURS), Diagnostic Interview for Adult ADHD 2nd edition (DIVA 2.0)
~psychiatric history : Mini International Neuropsychiatric Interview 5th edition (MINI 5.0), Personality Disorder Questionnaire for the DSM-IV (PDQ-4)
~cognitive functions : Frontal Assessment Battery (FAB), Montreal Cognitive Assessment (MoCA)
~impulsivity : Barratt's Impulsiveness scale 11th edition (BIS-11)
~alcohol consumption: alcohol - timeline follow-back (A-TLFB) ,administered at baseline (month before hospitalization), week 4 visit, week 6 visit, and week 12 visit.
~administered at week 12: ASRS"
16072512|NCT02364804|Drug|Aprepitant|The incidence and grade of chemotherapy-induced nausea and vomit (CINV) will be assessed in patients receiving Aprepitant for the prevention of CINV upon the combination chemotherapy of nedaplatin and docetaxel for NSCLC. These data will be compared with those surveyed retrospectively in patients who had received the combination chemotherapy with anti-emetic agents but Aprepitant.
16072513|NCT02364791|Device|standard techniques used to achieve air leak control|
16072514|NCT02364791|Device|Hemopatch|
16072515|NCT02364765|Drug|Remifentanil|Elective bimaxillary orthognathic surgery consisting of a unsegmented LeFort I osteotomy combined with a bilateral sagittal split osteotomy, under the influence of mean remifentanil administration of 0.3 mg/kg/hour
16072516|NCT02364752|Procedure|Blood Draw|
16072517|NCT02364752|Procedure|Loop Diuretic Withdrawal/Salt Load|
16072518|NCT02364739|Other|Written information|Brochure
16072519|NCT02364739|Other|Written and oral information|Written information consists in a brochure with information about fertility, while oral information consists in a tailored oral explanation about the wrong answers to the pre-test (that is related to the brochure).
16072520|NCT02364726|Procedure|Acupuncture|Each treatment session will be approximately 40 minutes in duration, 10 minutes to insert needles, 30 minutes to leave needles in. Patients will receive one acupuncture treatment each week until the end of chemotherapy. Adverse effects related to the administration of acupuncture will be collected each week before and after each treatment by the acupuncturist or research study assistant. All Integrative Medicine Service acupuncturists are licensed, credentialed employees of MSK.
16072521|NCT02364726|Behavioral|Neuropathic Pain Scale (NPS) questionnaire|It will be collected weekly throughout the screening phase, as well as, at the time of intervention consent, weekly during the intervention, and then once again after the last acupuncture session before the last chemotherapy session.
16072522|NCT02364726|Behavioral|FACT/GOG-Ntx questionnaire|It will be collected weekly throughout the screening phase, as well as, at the time of intervention consent, weekly during the intervention, and then once again after the last acupuncture session but before the as the last chemotherapy session, and then once again 3 months (+/-2 weeks) after chemotherapy completion.
16072523|NCT02364713|Biological|Bevacizumab|Given IV
16072524|NCT02364713|Drug|Gemcitabine Hydrochloride|Given IV
16072525|NCT02364713|Other|Laboratory Biomarker Analysis|Correlative studies
16072526|NCT02364713|Biological|Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter|Given IP
16072527|NCT02364713|Drug|Paclitaxel|Given IV
16072528|NCT02364713|Drug|Pegylated Liposomal Doxorubicin Hydrochloride|Given IV
16072529|NCT02364713|Other|Quality-of-Life Assessment|Ancillary studies
16072530|NCT02364713|Drug|Topotecan Hydrochloride|Given IV
16072531|NCT02364700|Device|Hand of Hope (HOH)|"Subjects will receive arm training 3x/week for 6 weeks, each session is anticipated to last approximately 60 minutes. Sessions will be scheduled for Monday, Wednesday, and Friday whenever possible to provide a rest period between sessions. Each session will consist of the following:
~warm up-passive stretch of hand in flexion and extension (5 minutes);
~setting the EMG threshold parameters for the device;
~active practicing of opening the hand (Desperate Bee, Hungry Bird, Sun Archer games; 10 min)
~active practice of closing then hand (UFO Catcher game; 10 min)
~open and closing the hand (Ball and Basket game; 10 min)
~open and closing the hand while incorporating reach ( for subjects with adequate ability to reach with shoulder/elbow; 10 min)
~cool down-passive stretch of hand in flexion and extension (5 minutes)"
16072532|NCT02364687|Radiation|Computed tomography late enhancement imaging|
16072533|NCT02364674|Radiation|High Resolution Computed Tomography scan|"a HRCT scan at Functional Residual Capacity (FRC) and Total Lung Capacity (TLC) will be taken on visit 1, visit 2, visit 3, visit 4 and visit 5.
~An Upper Airway (UA) scan will be taken on visit 1."
16072534|NCT02364661|Behavioral|Over night starvation (fasting)|HBV viral load will be analyzed after over-night starvation versus following a morning meal
16072535|NCT02364648|Dietary Supplement|MitoQ|Mitochondria targeted antioxidant
16072536|NCT02364648|Dietary Supplement|Placebo|Placebo
16072537|NCT02364635|Drug|icosabutate|Single dose at each dose levet
16072538|NCT02364622|Device|Tranditional fiberoptic bronchoscopy|The accurate placement of left-sided DLT into the left main bronchus was facilitated by tranditional fiberoptic bronchoscopy.
16072539|NCT02364622|Device|Modified fiberoptic bronchoscopy|The accurate placement of left-sided DLT into the left main bronchus was facilitated by modified fiberoptic bronchoscopy
16072540|NCT02364622|Device|Flexible Trachway intubating stylet|The accurate placement of left-sided DLT into the left main bronchus was faciliated by using flexible Trachway intubating stylet.
16072541|NCT02364609|Drug|Afatinib Dimaleate|Given PO
16072542|NCT02364609|Biological|Pembrolizumab|Given IV
16072543|NCT02364596|Biological|SA4Ag vaccine|Subjects receive 1 intramuscular injection (0.5 mL) of the SA4Ag vaccine.
16072544|NCT02364596|Procedure|Blood sample|Blood for immunogenicity will be collected from all subjects at various timepoints.
16072545|NCT02364583|Drug|Primaquine|Primaquine treatment given in a step-wise manner; (a) 0.5 mg/kg total dose daily for 14 days (n=40), (b) 1.0 mg/kg total dose daily for 7 days (n=40), (c) 1.0 mg/kg twice daily for 3.5 days (n=40)
16072546|NCT02364570|Other|Glucose (100g)|Ingestion of glucose (100g)
16072547|NCT02364570|Other|Glucose (75g)|Ingestion of glucose (75g)
16072548|NCT02364570|Other|Whole Eggs|Ingestion of 1.5 whole eggs
16072549|NCT02364570|Other|Egg Whites|Ingestion of 7 egg whites
16072550|NCT02364570|Other|Egg Yolks|Ingestion of 2 egg yolks
16072551|NCT02364557|Other|Laboratory Biomarker Analysis|Correlative studies
16072784|NCT02362646|Drug|Control Solution|
16072556|NCT02364544|Behavioral|Computer CBT for voices and paranoia|A ten-session CBT programs, one to address voices and the other for paranoia. The web-based programs incorporate the essential elements of CBT for psychosis such as normalizing behavior and offering behavioral coping strategies
16072557|NCT02364544|Behavioral|FOCUS|an interactive smart phone text-messaging application to support medication adherence, facilitate coping with symptoms and improve daily functioning in individuals with schizophrenia
16072558|NCT02364544|Other|Prescriber Decision Assistant|is a web-based prescriber decision support system that includes a brief patient-completed assessment describing symptoms and adverse events which prompts the prescriber to conduct a detailed clinical assessment. Embedded in the program are decision supports for medication choices based on best evidence-based practices regarding symptoms, side effects, information from laboratory tests and history of prior treatment response
16072559|NCT02364531|Other|Abiraterone Acetate (ZYTIGA): Prostate Cancer Registry|Participants will not receive any intervention in this study. The chemotherapy-naive metastatic castrate-resistant prostate cancer (mCRPC) participants who, on failing conventional androgen deprivation therapy (ADT), are prescribed to initiate Abiraterone Acetate (ZYTIGA) therapy as part of their physician's treatment approach for their asymptomatic or mildly symptomatic disease, will be observed in this study. Participants will receive standard of care therapy.
16072560|NCT02364518|Procedure|Snoreplasty|The procedure will be performed under local anesthesia in the examination chair. The subject's throat will be anesthetized with benzocaine spray followed by infiltration of the soft palate with 4-5 milliliters of 1% lidocaine with 1:100,000 epinephrine. The TranQuill suture will be inserted into the soft palate tissues using a predescribed pattern.
16072561|NCT02364505|Behavioral|Telemedicine mindfulness-based intervention|Comparison of telemedicine mindfulness intervention with telemedicine psycho-education control group
16072562|NCT02364505|Behavioral|Psycho-education intervention|Psycho-education control group, provided with a telemedicine approach. Subject in this group will use a similar software than the experimental intervention, with identical time efforts required. Software contents will be psycho-educative.
16072563|NCT02364492|Drug|MAG-TN3 + AS15|
16072564|NCT02364479|Drug|50mg Yisaipu|Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injection, 50mg per week
16072565|NCT02364479|Drug|25mg etanercept|Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein Injection, 25mg per week
16072566|NCT02364479|Drug|Placebo|The injection method and frequency of placebo is the same as the other arms.
16072567|NCT02364453|Drug|PACAP38|Giving doses of 4, 6 or 8 pg/kg/min on three separate trial days.
16072568|NCT02364440|Device|Ultherapy™ System|Subjects will receive 20 lines Ultherapy™ System Treatment over their right and left hand with 1.5 and 3.0 probe respectively
16072569|NCT02364427|Device|Arterial stiffness - Vicorder to measure pulse wave velocity|Pulse wave velocity (PWV)measures the stiffness of the arteries. This provides a simple and quick noninvasive method of obtaining the PWV for an arterial segment.
16072570|NCT02364414|Device|3Shape TRIOS (R)|Direct intra-oral scan of teeth and dentition
16072571|NCT02364401|Device|Ablation|Catheter ablation for atrial fibrillation
16072572|NCT02364388|Device|Imagio IUS|Imagio diagnostic gray-scale ultrasound
16072573|NCT02364388|Device|Imagio OA/US|Diagnostic opto-acoustic +gray-scale ultrasound
16072574|NCT02364375|Device|Menai mask (full face)|Prototype mask system (full face variant) with novel vent and humidification system
16072575|NCT02364375|Device|Menai Standard mask (full face)|Prototype mask system (full face variant) with conventional vent and humidification system
16072576|NCT02364375|Device|Menai mask (nasal)|Prototype mask system (nasal variant) with novel vent and humidification system
16072577|NCT02364375|Device|Menai Standard mask (nasal)|Prototype mask system (nasal variant) with conventional vent and humidification system
16072578|NCT02364375|Device|Menai mask (pillows)|Prototype mask system (pillows variant) with conventional vent and humidification system
16072579|NCT02364375|Device|Menai Standard mask (pillows)|Prototype mask system (pillows variant) with conventional vent and humidification system
16072580|NCT02364362|Drug|famitinib L + docetaxel|famitinib 15mg qd + docetaxel 60 mg/m^2
16072581|NCT02364362|Drug|famitinib M + docetaxel|famitinib 20mg qd + docetaxel 60 mg/m^2
16072582|NCT02364362|Drug|famitinib H + docetaxel|famitinib 25mg qd + docetaxel 60 mg/m^2
16072583|NCT02364349|Drug|Bee Venom (BV)|Raw Bee Venom
16072584|NCT02364349|Drug|Essential Bee Venom (e-BV)|Bee venom without Hyaluronidase, Lysophospholipase, α-D-glucosidase, PLA2, Adolapin
16072585|NCT02364336|Drug|Peginterferon alfa-2a|
16072586|NCT02364323|Behavioral|Personalized Risk Counselling|Motivational message- towards lifestyle change, improved compliance and risk factors control Review overall control of clinical risk factors based on lab test results
16072587|NCT02364323|Other|Normal usual care|General education on diabetes and diabetic complications
16072588|NCT02364310|Device|Baroreceptor stimulation with Barostim Neo TM|
16072589|NCT02364297|Device|Early TIPS|TIPS (first 5 days)
16072590|NCT02364271|Other|Thrombolysis in myocardial infarction score|An English- and Cantonese-speaking research nurse obtained the TIMI scores which consists of seven variables from each eligible patient.
16072591|NCT02364271|Biological|routine blood test for hs-cTnT|Patient had routine venipuncture blood taking for hs-cTnT measurement in the central laboratory of the hospital. Normal level of hs-cTnT is below 14ng/L.
16072592|NCT02364271|Other|HEART score|The modified HEART score of each patient was determined retrospectively by a research assistant.
16072593|NCT02364258|Drug|Rosuvastatin|Rosuvastatin 10mg tablet (ages 8-21 years); 1 time dose given per oral at the start of the study day.
16072594|NCT02364258|Drug|Atorvastatin|Atorvastatin 10mg tablet (ages 8-21 years); 1 time dose given per oral at the start of the study day.
16072595|NCT02364245|Device|Kinect|Receive computer games training for 30 minutes. There are 3 sections for 1 week; the intervention period will be 8 weeks.
16072596|NCT02364245|Other|Traditional OT(30 Mins)|Receive Traditional Occupational Therapy training for 30 minutes. There are 3 sections for 1 week; the intervention period will be 8 weeks.
16072597|NCT02364245|Other|Traditional OT(60 Mins)|Receive Traditional Occupational Therapy training for 60 minutes. There are 3 sections for 1 week; the intervention period will be 8 weeks.
16072599|NCT02364219|Other|Prewarming|Patients are treated according to standard operating procedures plus prewarming period of at least 30 minutes during induction of combined general and epidural anesthesia.
16072600|NCT02364219|Device|Microdialysis|71 High Cut-Off Brain MD Catheter Membrane cut-off: 100 kDa Membrane length 30 mm Shaft length: 60 mm Dialysis AB, Stockholm, Sweden
16072601|NCT02364206|Drug|LY2228820|
16072602|NCT02364206|Drug|Temozolomide|
16072603|NCT02364206|Radiation|radiotherapy|
16072604|NCT02364193|Device|MRI|"Cardiac MRI for LVEF and segmentation.
~Phase-contrast MRI for CO in aorta and each pulmonary vein.
~DCE-MRI for bolus kinetic parameter analysis."
16072605|NCT02364193|Drug|Gd-CA|Bolus kinetic parameter analysis, different doses of Gd-CA (Dotarem by Guerbet) ranging between 0.1 and 0.5 mmol will be injected intravenously after dilution in 5 milliliter saline by an injector at a speed of 5 ml/s.
16072606|NCT02364193|Device|BIS ImpediMed™ SFB7|"BIS will be measured by Bio-impedance spectroscopy will be performed using ImpediMed™ SFB7 (ImpediMed Limited 2008).
~Impedance will be measured continuously during the fluid challenge and for maximum 600 seconds before and after the fluid challenge.
~Currents of different frequencies will be applied; the resulting voltage will be recorded, with a time resolution for the complete frequency span not lower than 2 seconds."
16072607|NCT02364193|Device|Autotransfusion Lympamat Digital Gradient system|Lympamat Digital Gradient system (Bosl, Aachen) inflatable leg compression trousers will induce an autotransfusion by compressing the legs with a maximum of 90 mmHg for a maximum of 300 seconds
16072608|NCT02364180|Diagnostic Test|Electromyography (EMG)|
16072609|NCT02364167|Drug|Standard therapy|Standard therapy includes pharmacologic treatment of postoperative pain according to the standards of our University hospital
16072610|NCT02364167|Device|Verum acupuncture|"Verum acupuncture will be performed using indwelling permanent acupuncture needles New Pyonex with 1,5 mm length, manufactured by Seirin Corp. Japan"
16072611|NCT02364167|Other|Placebo acupuncture|"Placebo acupuncture will be performed using the placebo New Pyonex adhesive tapes, mimicking the needles, manufactured by Seirin Corp. Japan"
16072612|NCT02364154|Other|Control group-Blood sampling|Determine the metabolic phenotype of blood plasma by NMR spectroscopy
16072613|NCT02364154|Other|Blood sampling|determine amount and type of free circulating miRNA in blood plasma
16072614|NCT02364141|Other|Trunk restraint therapy|"Reaching training with trunk restraint by a harness that limited the trunk movements.
~Forty-five training minutes, twice a week, totaling twenty sessions, were performed. The training was based in the motor learning concepts including repetitive and task-specific practice. The training task consisted of grasping a cone (3.5 cm diameter base, 13 cm high) and fitting random targets as requested by the therapist in a training platform (54 cm length, 64 cm extent, 1.5 cm high) with 9 targets (6.5 cm diameter) placed 10-13 cm apart, along 3 lines. The targets that were ordered in a way that stimulated the complete range of motion of shoulder and elbow, had pictures, colors, letters and numbers on them yielding variability and feedback to the performing tasks."
16072615|NCT02364141|Other|Trunk unrestraint therapy|"Unrestraint reaching training, only with verbal feedback to maintain the trunk right position.
~Forty-five training minutes, twice a week, totaling twenty sessions, were performed. The training was based in the motor learning concepts including repetitive and task-specific practice. The training task consisted of grasping a cone (3.5 cm diameter base, 13 cm high) and fitting random targets as requested by the therapist in a training platform (54 cm length, 64 cm extent, 1.5 cm high) with 9 targets (6.5 cm diameter) placed 10-13 cm apart, along 3 lines. The targets that were ordered in a way that stimulated the complete range of motion of shoulder and elbow, had pictures, colors, letters and numbers on them yielding variability and feedback to the performing tasks"
16072616|NCT02364128|Behavioral|Decider Guider: Weight Loss|Decision aid tool about weight loss treatment
16072617|NCT02364115|Radiation|Stereotactic Body Radiotherapy|
16072618|NCT02364089|Procedure|Laparoscopic surgical removal of the adrenal tumor|
16072619|NCT02364089|Drug|Standardized medical treatment of hypertension by SAHR|"Standardized anti-hypertensive drug regimen has been established according to international recommendations and includes the following steps:
~step 1: Angiotensin converting enzyme inhibitor (ACE-I) or angiotensin II receptor antagonist (ARBs) at half-dose (Ranipril 5mg or Ibesartan 150 mg )
~step 2: CEI or ARA2 at full dose (Ranipril 10 mg or Ibesartan 300 mg)
~step 3: Add-on of Amlodipine 10 mg or Diltiazem LP 300 mg
~step 4: Add-on of Indapamide LP 1.5 mg
~step 5: Add-on of Spironolactone 25 mg
~step 6: Add-on of Bisoprolol 10 mg
~step 7: Add-on of Prazosine LP 5mg/day."
16072620|NCT02364076|Drug|Pembrolizumab|Administration of 200 mg MK-3475 once every 3 weeks
16072621|NCT02364076|Drug|Epacadostat|100mg taken by mouth twice daily
16072622|NCT02364063|Other|urotherapy with or without pharmacotherapy|Individualized
16072623|NCT02364037|Behavioral|CHOICE Project Structured Contraceptive Counseling|Women in both phases of the study will receive the structured contraceptive counseling developed by the Contraceptive CHOICE Project.
16072624|NCT02364037|Behavioral|Contraceptive Education Session|Prior to Phase 2, health care providers at the recruitment sites will undergo a contraceptive education session with a focus on evidence-based provision of contraception including LARC (IUDs and implant) and same-day insertion.
16072625|NCT02364037|Device|Cost Support for IUDs and implants|Women in Phase 2 of the study who desire an IUD or implant can receive one through the study at no cost if they do not have insurance coverage. If women have insurance that covers the device, her insurance will be billed for the cost of the device.
16072626|NCT02363998|Drug|Lofexidine|All enrolled subjects will take lofexidine orally for 7 days, starting on Day 1 at a dose of 3.2 mg per day (0.8 mg QID), with lowering of the dose allowed to 2.4 mg daily (0.6 mg QID) if required for tolerability based on the subject's individual treatment goal and response per clinical judgment of the Principal Investigator.
16072627|NCT02363985|Dietary Supplement|Mega-dose of vitamin A supplement|vitamin A supplementation normally given every six months for under five children in Ethiopia. In addition, there is also dietary intervention like orange flash sweet potato and promotion of other vitamin A rich foods to tackle vitamin A deficiency in Ethiopia.
16072628|NCT02363972|Device|Ellipsys Vascular Access Catheter|A one-time use vascular catheter used as a less invasive means of creating an AV fistula. Screening and follow-up assessments are standard of care for surgical AV fistulae.
16072702|NCT02363361|Drug|Imatinib|Day 1. 800 mg, Day 2-14: 2 * 400 mg per day
16072629|NCT02363959|Drug|Hyperbaric Oxygen Therapy|2 hours of breathing >99% medical grade oxygen inside an air-pressurized chamber at 2 ATA once a day for 20 sessions. These sessions will be scheduled 3-5 times per week, depending on the availability of the patient and the hyperbaric medicine physician.
16072630|NCT02363959|Procedure|Endobronchial Biopsy of Airway Epithelium|During standard post-transplantation bronchoscopies, participants in this study will undergo an endobronchial biopsy of the airway epithelium for each donor lung.
16072631|NCT02363946|Drug|ARC-AAT Injection|RNA interference-based, liver-targeted therapeutic
16072632|NCT02363946|Other|Placebo|0.9 % normal saline
16072633|NCT02363946|Drug|Diphenhydramine|Diphenhydramine 50 mg p.o. was administered 2 hours (±30 minutes) pre-dose as antihistamine pre-treatment.
16072634|NCT02363933|Drug|Perampanel|Perampanel is a highly selective non-competitive alpha-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid (AMPA) type glutamate receptor antagonist that has shown efficacy in a randomized phase III study for refractory partial-onset seizures
16072635|NCT02363920|Device|HOF|the addition of high oxygen flow to patients breathing spontaneously
16072636|NCT02363920|Device|noninvasive mechanical ventilation (NIV)|the addition of a ventilatory support delivered with a oro-nasal interface
16072637|NCT02363855|Drug|BAY 1841788(ODM-201)|Cohort 1: Single dose 300 mg BAY 1841788, followed by twice daily administration of the same dose for 12 weeks Cohort 2: Single dose 2x300 mg BAY 1841788, followed by twice daily administration of the same dose for 12 weeks.
16072638|NCT02363842|Device|Skin IQ™ MCM Coverlet|Test article is the Skin IQ™ MCM, a Class II 510k exempt product. It is an overlay coverlet indicated to be used in conjunction with a pressure redistribution surface in order to aid in the prevention and treatment of skin breakdown and pressure ulcers for patients who require microclimate management of the skin.
16072639|NCT02363842|Other|Pressure redistribution surface|Standard of Care (SOC): pressure redistribution surface already in use at the participating institution to manage patients at risk for tissue breakdown
16072640|NCT02363829|Drug|Nelfinavir|
16072641|NCT02363829|Biological|Cisplatin|
16072642|NCT02363803|Drug|lidocaine|lidocaine is a sodium channel blocker/analgesic. It is approved for intravenous administration for cardiac arrhythmias.
16072643|NCT02363803|Drug|Placebo|Normal saline, approved for hypovolemia, and homeostasis.
16072644|NCT02363790|Procedure|LVHR PFC|Information included in arm description
16072645|NCT02363790|Procedure|Bridging LVHR|Information included in arm description
16072646|NCT02363777|Procedure|Epidural|A mid thoracic epidural is placed preoperatively and a local anesthetic and opioid infusion is run postoperatively
16072647|NCT02363777|Procedure|Paravertebral catheters|Bilateral paravertebral catheters are placed and a local anesthetic infusion via an elastomeric pump is run postoperatively
16072648|NCT02363764|Procedure|Nasal swab|"Will be obtained by the physiotherapist in:
~Expectorating CF patients
~Non-expectorating CF patients
~Bronchoscopy CF patients"
16072649|NCT02363764|Procedure|Cough swab|"Will be obtained by the physiotherapist in:
~Expectorating CF patients
~Non-expectorating CF patients
~Bronchoscopy CF patients"
16072650|NCT02363764|Procedure|Spontaneous expectorated sputum|"Will be obtained by the physiotherapist in:
~- Expectorating CF patients"
16072651|NCT02363764|Procedure|Induced sputum|"Will be obtained by the physiotherapist in:
~Non-expectorating CF patients
~Bronchoscopy CF patients"
16072652|NCT02363764|Procedure|Bronchoalveolar lavage|"Will be obtained by the pulmonologist in:
~- Bronchoscopy CF patients"
16072653|NCT02363764|Other|Questionnaire|Completing questionnaire on acceptability of different sampling methods by patients >6 years of age
16072654|NCT02363751|Drug|Bevacizumab|"Patients will be treated for a maximum of 6 (21days) chemotherapy cycles (Gemcitabine+platinum salt+bevacizumab).
~In case of disease control (complete, partial or stable disease) treatment with bevacizumab 15 mg/Kg monotherapy every 21 days will be continued until disease progression or until the end of the 24 months of follow-up."
16072655|NCT02363738|Drug|Infliximab|Intravenous infliximab (5mg/kg) at baseline, week 2 and 6 under clinical observation. Infliximab will be prescribed adjunctively to a conventional mood stabilizer or atypical antipsychotic agent.
16072656|NCT02363738|Other|Saline|Intravenous placebo (saline solution) at baseline, week 2 and 6 under clinical observation. Placebo will be matched to infliximab in color and consistency and will be administered adjunctively to conventional mood stabilizer or atypical antipsychotic agent.
16072657|NCT02363725|Drug|Colchimax®|
16072658|NCT02363725|Drug|Conventional treatment|
16072659|NCT02363712|Device|APOS shoe|"It consists of two shoes each with two large convex rubber balls called Pertupods screwed into the plantar surface of the sole so that a person walks on these balls."
16072660|NCT02363712|Device|Sham-APOS shoe|It has the same appearance as the APOS shoe, but without the rubber ball attachment on the plantar surface.
16072661|NCT02363699|Drug|Lidocaine|Lidocaine was administered in bolus of 1.5 mg.kg-1 at the start of the procedure and maintained at a dose of 3 mg.kg-1.h-1 until one hour after the end of the procedure. Solution of 0,3% lidocaine was used, so that the infusion rate was equal to the weight of the patient.
16072662|NCT02363699|Drug|Saline solution|Saline solution was administered in bolus of 1.5 mg.kg-1 at the start of the procedure and maintained at a dose of 3 mg.kg-1.h-1 until one hour after the end of the procedure.
16072663|NCT02363686|Procedure|FEES|A thin, flexible endoscope designed for assessment of laryngeal structures is passed through the nose to the oropharynx, visualizing the laryngeal structures, and the base of tongue and the pharynx. If needed 4% topical lidocaine and/or oxymetazoline (Afrin) will be administered. Swallowing will then be evaluated directly with six food boluses of 5 ml each. All patients will be allowed to swallow spontaneously without a verbal command to swallow. Video of the examinations will be recorded and presence of dysphagia will be designated independently by 3 different observers (one pulmonary physician and two speech language pathologists (SLPs)). This procedure will take 5-10 minutes. The camera will then be removed.
16072664|NCT02363686|Procedure|BSE|Following the FEES, a speech language pathologist (SLP) will perform a noninvasive bedside swallow evaluation (BSE). The SLP will be blinded to the results of the FEES, and the name of the SLP performing the BSE will not be recorded. No other identifying information will be collected regarding the SLP performing the test.
16072703|NCT02363348|Dietary Supplement|L arginine|L arginine is a basic amino-acid precursor of nitric oxide main vasodilator.
16072704|NCT02363348|Other|Placebo|calcined magnesia
16072665|NCT02363673|Other|Individualised homoeopathic remedy in aqua distilla|Each participant is to receive an individualised homoeopathic remedy according to their symptoms and characteristic manifestations of their disorder.
16072666|NCT02363660|Biological|GINI|
16072667|NCT02363647|Other|Tumor Genomic Analysis|"Tumor mutations identified by deep DNA and RNA sequencing of individual tumors are screened for tumor drivers, which are then incorporated into the personal Drosophila model and tested against a library of FDA approved drugs. Fly mortality is used as a surrogate for toxicity and increased survival to adulthood; improvements in tumor mutation-linked eye and/or wing abnormalities serve to quantify efficacy. This allows rapid and parallel screening of FDA approved drugs and subsequent drug combinations. The most efficacious and least toxic combinations are tested in xenograft models and a multidisciplinary tumor board of experts select the best therapeutic option. The objective is to demonstrate that the personalized drosophila model approach is superior to the current standard. Patient will be offered an unique personalized single drug or combination of drugs, all FDA approved, based on the Drosophila drug screening process."
16072668|NCT02363634|Dietary Supplement|magnesium threonate|nutritional product
16072669|NCT02363621|Drug|Ranibizumab 0.3 mg|Ranibizumab 0.3 mg Patient will receive intravitreal injection of Ranibizumab 0.3 mg
16072670|NCT02363621|Drug|Aflibercept 2.0 mg|Patient will receive intravitreal injection of Aflibercept 2.0 mg
16072671|NCT02363608|Other|standard post surgery care|
16072672|NCT02363608|Behavioral|Caring Canine program|The therapy dogs who visit at MSKCC. A visit by a therapy dog typically lasts about 10-15 minutes with the patient interacting with the therapy dog while the dog is supervised by the handler.
16072673|NCT02363608|Behavioral|baseline and post assessment|The baseline and post assessment will include the Professional Quality of Life Scale (ProQOL R-IV) (Stamm, 1997-2005) and qualitative questions.
16072674|NCT02363582|Other|formula|An infant formula contains prebiotics and lactoferrin
16072675|NCT02363556|Procedure|Misoprostol administered vaginally|
16072676|NCT02363556|Procedure|Misoprostol administered buccally|
16072677|NCT02363556|Procedure|Misoprostol administered vaginally with Dilapan|
16072678|NCT02363556|Procedure|Misoprostol administered buccally with Dilapan|
16072679|NCT02363543|Device|Hyalomatrix|
16072680|NCT02363543|Device|Integra|
16072681|NCT02363530|Device|Hydroxypropyl ethylcellulose (HPMC) 2% gel|We use the hydroxypropyl ethylcellulose (HPMC) 2% gel instead of the traditional balanced salt solution during the cataract surgery.
16072682|NCT02363530|Device|BSS|Balanced Salt Solution including normal saline and glucose
16072683|NCT02363517|Drug|Sofosbuvir/ledispasvir fixed dose combination (SOF + LDP)|SOF + LDV tablets contain 400mg of SOF and 90mg of LDV.
16072684|NCT02363504|Other|7 Tesla MRI with memory task and non-invasive neurostimulation|This is not an intervention, we investigate the neural mechanisms
16072685|NCT02363491|Drug|OPN-305|For the dose confirming part of the study, patients will receive a starting dose of 5 mg/kg OPN-305.
16072686|NCT02363478|Drug|buspirone|buspirone 10 mg X2 for 4 weeks
16072687|NCT02363465|Other|Echographic measurement of skin thickness|"(Epi)Dermal thickness at the proximal forearm and the deltoid region will be measured using imaging technology, more specifically high-frequency ultrasound (20-40 MHz) in B-mode (VEVO 2100®, Visual Sonics). This non-invasive measuring technique has already been proven to be accurate.
~The echographic measurement will be performed on the left and right deltoid region and on two sides of the proximal forearm. Both the dorsal part and the volar/palmar part of the proximal forearm will be investigated. Ultrasound will be executed using gel (Aquasonic®) to optimize imaging."
16072688|NCT02363452|Drug|Reverse transcriptase inhibitors: Zidovudine, Lamivudine, Abacavir|Oral Solution (syrup) or Tablets
16072689|NCT02363439|Drug|IMO-8400 0.6 mg/kg/wk or 1.2 mg/kg twice weekly|IMO-8400 at 0.6 mg/kg/wk or 1.2 mg/kg twice weekly as defined per Protocol 8400-401
16072690|NCT02363426|Device|INVOcell Culture Device|INVOcell is a vaginal culture device
16072691|NCT02363426|Device|IVF Incubation|IVF Incubator
16072692|NCT02363413|Other|IniVAH|Initiation of the NIV during a 3 days hospitalization as usual.
16072693|NCT02363413|Other|IniVAD|Initiation of the NIV at home. The first day, the kinesiologist and the technician start-up the NIV at home with the patient. The investigator will validate the adjustment settings proposed by the kinesiologist. No procedure during the second day as described by the HAS. The third day, the kinesiologist and the technician come back to the patient home so as to adjust the settings if needed and if validated by the investigator.
16072694|NCT02363400|Drug|MEP|Adjuvant Chemotherapy
16072695|NCT02363387|Behavioral|Incentives for Viral Suppression|Incentive group participants will receive incentives for maintaining suppressed and undetectable viral loads. The incentive program will employ high magnitude incentives, provide incentives for decreases in viral load early in treatment before a patient's viral load has reached undetectable levels, arrange frequent incentives early in treatment and reduce the frequency of incentives as participants achieve progressively longer periods of viral load suppression, arrange a schedule of escalating incentives for sustained suppression of viral load, and the intervention will be maintained for two years.
16072696|NCT02363387|Behavioral|Standard HIV Medical Care|The best HIV medical care available in each participant's medical clinic.
16072697|NCT02363374|Drug|Induction Chemotherapy arm A|"Patients receive three induction chemotherapy cycles, starting on day 1, 15 and 29, consisting of:
~Folinic acid: 400 mg/sqm, 2h-iv; Oxaliplatin: 100 mg/sqm, 2h-iv; 5-FU: 2400 mg/sqm, 46h-iv
~After a break of two weeks, radiotherapy starts combined with:
~5-FU: 250 mg/sqm per day, iv, on day 43-57, day 64-77 Oxaliplatin: 50 mg/sqm, day 43, 50, 64, and 71"
16072698|NCT02363374|Radiation|Radiation arm A|Radiotherapy: 28 x 1.8 Gy (total: 50.4 Gy), 5 fractions per week on day 43 -80
16072699|NCT02363374|Radiation|Radiation arm B|Radiotherapy: 28 x 1.8 Gy (total: 50.4 Gy), 5 fractions per week on day 1- 38
16072700|NCT02363374|Drug|Chemotherapy arm B|"chemoradiotherapy is started according to the following schedule: 5-FU: 250 mg/sqm per day, iv, on day 1-14, day 22-35; Oxaliplatin: 50 mg/sqm, day 1, 8, 22, and 29.
~After a break of two and a half weeks, patients receive three chemotherapy cycles, starting on day 57, 71 and 85, consisting of:
~Folinic acid: 400 mg/sqm, 2h-iv; Oxaliplatin: 100 mg/sqm, 2h-iv; 5-FU: 2400 mg/sqm, 46h-iv"
16072701|NCT02363374|Procedure|Surgery|Surgery should be performed about 5 (arm B) or 6 (arm A) weeks after the last radiation or chemotherapy, i.e. around day 123
16072707|NCT02363335|Drug|Sitagliptin|This is already known to increase GLP-1 &amp; GIP secretion.
16072708|NCT02363335|Drug|Roflumilast|This is already known to increase GLP-1 &amp; GIP secretion
16072709|NCT02363322|Drug|B/Current Standard of Care Plus ZMapp|Triple monoclonal cocktail of antibodies against Zaire species of Ebola virus
16072710|NCT02363322|Other|A/Current Standard of Care Alone|Optimized standard of care for Ebola virus infection
16072712|NCT02363283|Drug|Glembatumumab Vedotin|Given IV
16072713|NCT02363283|Other|Laboratory Biomarker Analysis|Correlative studies
16072714|NCT02363283|Other|Pharmacological Study|Correlative studies
16072715|NCT02363270|Procedure|Ketamine|IV Push or or IV Drip
16072716|NCT02363218|Radiation|CyberKnife|Patients will undergo a CT scan with and without contrast and MRI scan for radiation treatment planning and target delineation.SBRT will be delivered on the CyberKnife with Synchrony Respiratory Tracking capabilities. The tumor will be tracked with 3 implanted fiducial seeds for targeting. Treatment will be delivered in 3 fractions within a 7 day window at the discretion of the investigator.
16072717|NCT02363205|Behavioral|Tailored Internet-administrated CBT-Treatment|Guided internet-delivered CBT with chat sessions
16072718|NCT02363192|Behavioral|Pharmacist intervention and pharmacist support|Patients randomised to this group will undergo an asthma assessment to assess asthma control, adherence and inhaler technique, by an Advanced Clinical Pharmacist specialising in Respiratory Medicine.
16072719|NCT02363179|Behavioral|Live preferential music|Live preferential music will be performed for patients in the emergency department.
16072720|NCT02363166|Other|Acute Abscess Group|Samples collected for culture and sensitivity testing depending on acute abscess, or skin/soft tissue infection.
16072721|NCT02363153|Other|Diet and Exercise|"Exercise will consist of 2x/week aerobic exercise, 2x/week strength training and 1x/week core-stabilizing exercise.
~Diet will be constructed so that 30% of the daily caloric goal will be protein, 35% fat, and 35% carbohydrates."
16072722|NCT02363140|Other|Will undergo a single MRI assessment with intravenous dye|
16072723|NCT02363140|Other|pre and post surgery MRI scan|
16072724|NCT02363127|Drug|subcutaneous progesterone|subcutaneous progesterone 25 mg/day
16072725|NCT02363127|Drug|vaginal progesterone|vaginal progesterone in capsules 200 mg/3 times a day
16072726|NCT02363088|Other|Neutral text message reminder|"Your cervical smear test is due. To book please call <xxxxxxxxxxx>"
16072727|NCT02363088|Other|Messenger text message reminder|"<GP NAME>: Your cervical smear test is due. To book please call <xxxxxxxxxxx>"
16072728|NCT02363088|Other|Social Norms A reminder|"Last year in Hillingdon 7 out of 10 women took part in cervical screening. Your cervical smear test is due. To book please call <xxxxxxxxxxx>"
16072729|NCT02363088|Other|Social Norms B reminder|"Last year 12000 women in Hillingdon took part in cervical screening. Your cervical smear test is due. To book please call <xxxxxxxxxxx>"
16072730|NCT02363088|Other|Framed Gain text reminder|"Cervical cancer screening saves 4500 lives in England every year. Your cervical smear test is due. To book please call <xxxxxxxxxxx>"
16072731|NCT02363088|Other|Framed Loss text reminder|"Failing to attend cervical screening could lead to 4500 avoidable deaths in England each year. Your cervical smear test is due. To book please call <xxxxxxxxxxx>"
16072732|NCT02363075|Drug|Dexamfetamine sulphate|10mg/day per os for the first ten days, 20mg/day for the ten following days, 30mg/day until D90.
16072733|NCT02363075|Drug|placebo|10mg/day per os for the first ten days, 20mg/day for the ten following days, 30mg/day until D90.
16072734|NCT02363049|Procedure|Colectomy|
16072735|NCT02363049|Drug|Chemotherapy|
16072736|NCT02363023|Procedure|Collect tracheal and pulmonary secretions|Collect tracheal and pulmonary secretions (endotracheal aspirate, bronchoscopic and non-bronchoscopic bronchoalveolar lavage)
16072737|NCT02363010|Behavioral|Gold Standard Behavior Therapy for Weight Loss|Group- based behavioral treatment for weight loss and weight loss maintenance, with a standard emphasis on diet (65% of session) and physical activity goals (25% of session). Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session).
16072738|NCT02363010|Behavioral|Behavior Therapy for Weight Loss with Physical Activity Emphasis|Group-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session).
16072739|NCT02363010|Behavioral|Acceptance-based Behavior Therapy for Weight Loss with PA emphasis|Group-based, acceptance-based behavioral treatment for weight loss and weight loss maintenance, with a larger emphasis on physical activity goals (65% of session) than eating-related goals (25% of session).Other weight loss behaviors such as self monitoring will be covered in the remaining time (10% of session).
16072740|NCT02362997|Drug|Pembrolizumab|Anti-PD-1 monoclonal antibody
16072741|NCT02362984|Drug|Placebo|Placebo of DLBS1033 will be given in addition to the standard therapy consisting of: aspirin enteric-coated tablet 1 x 80 mg daily, simvastatin film-coated tablet 1 x 20 mg daily, vitamin B complex 1 x 1 tablet daily, and citicholine injection 250 mg/2 mL twice daily
16072742|NCT02362984|Drug|DLBS1033|DLBS1033 enteric-coated tablets will be given in addition to the standard therapy consisting of: aspirin enteric-coated tablet 1 x 80 mg daily, simvastatin film-coated tablet 1 x 20 mg daily, vitamin B complex 1 x 1 tablet daily, and citicholine injection 250 mg/2 mL twice daily
16072743|NCT02362958|Drug|lapatinib and capecitabine or vinorelbine|lapatinib 1250 mg qd and Capecitabine 1000 mg/m2 bid or Vinorelbine 25mg/m2(d1,d8)
16072744|NCT02362945|Drug|Intervention group:|Treatment with 1 gr hexakapron Intra-Venous (IV) after delivery of the fetus in addition to accepted treatment with oxytocin (10 units in 100ml NaCl 0.9% solution IV).
16072745|NCT02362932|Other|Sanitation|Shared sanitation
16072746|NCT02362906|Drug|Xiyanping injection|ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection
16072747|NCT02362906|Drug|wind-heat formula granules|children aged 6 months to 3-year old: 1/2 packet，orally taken two times daily or frequency; children aged 3 to 5-year old: 2/3 packet，orally taken two times daily or frequency; children aged 5 to 14-year old: 1 packet， orally taken two times daily or frequency
16072907|NCT02361645|Drug|Indomethacin 0.5% eyedrops|
16072748|NCT02362906|Drug|phlegm-heat formula granules|children aged 6 months to 3-year old: 1/2 packet，orally taken two times daily or frequency; children aged 3 to 5-year old: 2/3 packet，orally taken two times daily or frequency; children aged 5 to 14-year old: 1 packet， orally taken two times daily or frequency
16072749|NCT02362906|Drug|Fu-xiong San|external application; 8-10 cm wide, 0.3-0.5 cm thick;10 mins for patient aged 1 to 3-year old; 15 mins for those aged 3 to 5-year old; once daily
16072750|NCT02362906|Drug|second generation cephalosporin|
16072751|NCT02362906|Drug|Erythromycin|ivd. 30 mg/(kg•d), plus 5% Glucose Injection, 80 to 500 ml, ivd. Once a day injection
16072752|NCT02362906|Drug|Azithromycin|ivd. 10 mg/(kg•d), plus 5% Glucose Injection, 100 to 500 ml, ivd. Once a day injection
16072753|NCT02362893|Other|Direct Observed Therapy|Patients allocated to the intervention group take their medication (from original blister packaged) in front of the invistigator who observe the patient swallowing the medication. To secure the principals of Direct Observed Therapy, the patient do not leave the clinic for two hours.
16072754|NCT02362880|Radiation|Florbetaben|single dose of Florbetaben followed by PET scan
16072755|NCT02362867|Device|Balanced Knee System|A multi-compartmental total knee replacement providing a system of components for primary posterior cruciate ligament substituting procedures. The system consists of femoral, tibial, and patellar components that allow the surgeon to select the most appropriate component combination to meet specific patient needs.
16072756|NCT02362854|Procedure|Conventional peri-implantitis treatment|Elimination of the bacterial plaque. Establishing optimal healing conditions. Detoxification of the affected environment.
16072757|NCT02362854|Device|DL application in peri-implantitis|Diode laser application in the diseased implants.
16072758|NCT02362815|Other|Apple juice|Intervention consists in allowing drinks during labour
16072759|NCT02362802|Device|Implantable Cardioverter Defibrillator|
16072760|NCT02362789|Biological|Secukinumab|150 mg secukinumab in 1 ml solution for subcutaneous injection (pre-filled syringe)
16072761|NCT02362789|Biological|Placebo|Matching placebo in 1 ml solution for subcutaneous injection (pre-filled syringe)
16072762|NCT02362776|Other|Venous blood sample|Collection of a venous blood sample to investigate metabolic changes in blood
16072763|NCT02362763|Procedure|Acupuncture|Patients randomized to the study group received five sessions of acupuncture in a series of points in the lower abdomen, lower back, hands, and feet. This combination of acupoints is believed to impact on the genital area, raise the pain threshold, and counteract inflammation. Control group patients received five sessions of acupuncture at acupoints that are believed to have no influence on the genital area, but are believed to have a general sedative effect.
16072764|NCT02362750|Other|Organizational Interview|Survivorship program leaders will participate in a phone-based organizational interview regarding the organization of the clinical survivorship care program.
16072765|NCT02362750|Other|Organizational Survey|Survivorship program leaders will participate in a brief web-based organizational survey regarding the organization of the clinical survivorship care program.
16072766|NCT02362750|Other|Survivor Survey (1): Pre-Visit Baseline|Survivors will participate in a baseline survey regarding their satisfaction, health-related quality of life, ability to manage their cancer post-treatment and appropriate health care utilization.
16072767|NCT02362750|Other|Survivor Survey (2): Post-Visit|Survivors will participate in a survey within one week after their survivorship visit regarding their satisfaction, health-related quality of life, ability to manage their cancer post-treatment and appropriate health care utilization.
16072768|NCT02362750|Other|Survivor Survey (3): 3 Month Post-Visit|Survivors will participate in a survey three months after their survivorship visit regarding their satisfaction, health-related quality of life, ability to manage their cancer post-treatment and appropriate health care utilization.
16072769|NCT02362750|Other|Survivor Survey (4): 6 Month Post-Visit|Survivors will participate in a survey six months after their survivorship visit regarding their satisfaction, health-related quality of life, ability to manage their cancer post-treatment and appropriate health care utilization.
16072770|NCT02362750|Other|Clinician Survey|Survivorship program clinicians will complete a survey for each survivor who enrolls in the study indicating services provided through the survivorship visit.
16072771|NCT02362737|Behavioral|Active and Healthy Brotherhood (AHB)|Participants will attend group sessions led by trained group facilitators. The group sessions will be ~16 weekly meetings of ~90 minutes duration for 4 months. AHB participants will also engage in experiential learning opportunities. Following the intensive intervention phase, during months 5 and 6, participants will receive three structured, individual phone calls with the group facilitator.
16072772|NCT02362724|Device|Sapphire|silicone hydrogel contact lens
16072773|NCT02362724|Device|Pearl|silicone hydrogel contact lens
16072774|NCT02362711|Drug|NPC-16 Standard Dosing Regimen Group|
16072775|NCT02362711|Drug|NPC-16 Continuous Dosing Regimen Group|
16072776|NCT02362711|Drug|Placebo Group|
16072777|NCT02362698|Other|electro-acupuncture|"13points were selected including he-gu(LI4), nei-guan(PC6), tai-chong(LR3) and san-yin-jiao(SP6) from both sides, bai-hui(GV20) and si-shen-cong(EX-HN1) from head.
~HANS-200A acupoints stimulator, which had two output channels, was connected to some selected points. Dilatational wave was adopted in this research, the frequency of rarefaction wave was 2 hertz and condensation wave was 100 hertz, with a waviness width of 0.3ms. Switched the stimulator on after connected the poles to the needles, adjusted the intensity of output gradually from 0 milliampere to the extent of subject's maximum tolerance. Then needles would be remained on the body for half an hour."
16072778|NCT02362698|Other|psychological intervention|Cognitive behavioral therapy was adopted by national accredited professional psychologist, in the form of team work and individual counseling, aim to help IA participants to understand their deviant behaviors, correct unhealthy cognitive states and eventually retrieve normal life style.
16072779|NCT02362685|Device|functional test|subjects perform a metabolic exercise testing
16072780|NCT02362685|Genetic|matching genotype with phenotype|
16072781|NCT02362672|Drug|NKTR-181 BID tablets|NKTR-181 tablets 100-400 mg twice daily (BID)
16072782|NCT02362672|Drug|Placebo to match NKTR-181 BID tablets|Placebo to match NKTR-181 tablets 100-400 mg twice daily (BID)
16072783|NCT02362646|Biological|MPC Intramyocardial Injection|Intramyocardial injection of 150 million mesenchymal precursor cells at the time of LVAD implantation
16072785|NCT02362633|Device|real tDCS|For active tDCS, a 2 mA current will be delivered for 20 minutes with 20 second up and down ramp times. The anodal electrode will be placed on the right DLPFC (F4; 10-20 EEG system), and the cathode electrode will be placed on the left DLPFC (F4;10-20 EEG system), which is known to be related to cognitive function. The electrodes used for tDCS are saline-soaked sponges (25 cm2).
16072786|NCT02362633|Device|sham tDCS|Sham tDCS will be delivered for 20 minutes. The anodal electrode will be placed on the right DLPFC (F4; 10-20 EEG system), and the cathode electrode will be placed on the left DLPFC (F4;10-20 EEG system), which is known to be related to cognitive function. The electrodes used for tDCS are saline-soaked sponges (25 cm2).
16072787|NCT02362607|Behavioral|Integrated Diabetes Management Protocol|
16072788|NCT02362607|Behavioral|Standard Diabetes Management Protocol|
16072789|NCT02362594|Biological|pembrolizumab|Pembrolizumab 200 mg administered intravenously (IV) on Day 1 of each 21-day cycle
16072790|NCT02362594|Drug|placebo|Normal saline solution administered IV on Day 1 of each 21-day cycle
16072791|NCT02362581|Other|prophylaxis treatment, on demand treatment|
16072792|NCT02362568|Procedure|Ultrasound cervical exploration|The cervical ultrasound exploration will consist in the ultrasound measurement of the length between the hyoid bone and the skin and the length between the thyroid cartilage and the skin. The ultrasound cervical exploration will be performed in all patients admitted in the postoperative room after a planned surgery performed under general anesthesia.
16072793|NCT02362555|Other|no intervention was used in this observational study|
16072794|NCT02362542|Device|tDCS|For active tDCS, a 2 mA current will be delivered for 20 minutes with 20 second up and down ramp times. The anodal electrode will be placed on the right DLPFC (F4; 10-20 EEG system), and the cathode electrode will be placed on the left DLPFC (F4;10-20 EEG system), which is known to be related to cognitive function. The electrodes used for tDCS are saline-soaked sponges (25 cm2).
16072795|NCT02362529|Drug|Minocycline|50 mg and 100 mg capsule, oral administration
16072796|NCT02362529|Drug|Placebo|Lactose monohydrate in identical gel capsules to minocycline, oral administration.
16072797|NCT02362529|Drug|Celecoxib|100 mg and 200 mg capsules, oral administration.
16072798|NCT02362516|Drug|BI 425809|
16072799|NCT02362503|Drug|BMS-663068|BMS-663068
16072800|NCT02362503|Other|Placebo|Placebo
16072801|NCT02362490|Drug|peginterferon alpha 2a|in this group,patients will receive 180 ug of peginterferon alpha 2a injection weekly for 72 weeks
16072802|NCT02362477|Behavioral|Cognitive Processing Therapy in-person|Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, in-person.
16072803|NCT02362477|Behavioral|Cognitive Processing Therapy through videoteleconference|Cognitive Processing Therapy is delivered to female veterans and civilians, who have been diagnosed with PTSD, through videoteleconference.
16072804|NCT02362464|Biological|ME TARP vaccine|dose of 20 x 10^6 viable cells multiepitope TARP dendritic cell vaccine given intradermally at weeks 3, 6, 9, 12, 15 and 24.
16072805|NCT02362451|Biological|Autologus elutriated monocyte placebo vaccine|20x10^6 viable cells/dose at weeks 3, 6, 9, 12, 15 and 24
16072806|NCT02362451|Biological|ME TARP vaccine|20x10^6 viable cells/dose at weeks 3, 6, 9, 12, 15 and 24
16072808|NCT02362425|Drug|N-acetylcysteine|
16072809|NCT02362425|Drug|Placebo|
16072810|NCT02362412|Drug|FK949E|A tablet containing 50 mg or 150 mg of quetiapine taken orally.
16072811|NCT02362399|Drug|sildenafil citrate|single oral dose of 50 mg
16072812|NCT02362399|Other|placebo|single oral dose of placebo tablet
16072813|NCT02362386|Device|Celution Device|Non-interventional evaluation of Celution Device preparation of ADRCs from thermal burn eschar tissue that would normally be discarded.
16072814|NCT02362373|Drug|levonorgestrel IUS|placement of levonorgestrel intrauterine system
16072815|NCT02362360|Device|Coloplast Test Product|A new 2-piece ostomy appliance developed by Coloplast A/S
16072816|NCT02362360|Device|Comparator (Hollister)|Comparator is a Hollister FlexWear baseplate (ileostomy) or a Hollister SoftFlex baseplate (colostomy) both used with a Hollister open bag.
16072817|NCT02362347|Device|London Health Sciences Centre - Compression Vest|London Health Sciences Centre - Compression Vest
16072818|NCT02362347|Other|exercise|exercise
16072819|NCT02362321|Drug|Dexamethasone|Patients received a daily dosage of 12mg (4mg three times a day) of dexamethasone for three weeks. Corticosteroid treatment was then tapered off over the next week (8mg for 48 hrs, 4mg for 48 hrs, 2mg for 48 hrs and 1mg for 24 hrs).
16072820|NCT02362321|Other|Placebo|Identical oral capsules filled with lactose were administered to the control (placebo) group for 28 days.
16072821|NCT02362308|Other|Adrenalectomy|Adrenalectomy for treatment of primary aldosteronism, according to standard of care
16072822|NCT02362308|Drug|mineralocorticoid receptor antagonist|Subjects will be treated with a mineralocorticoid receptor antagonist according to standard of care
16072823|NCT02362295|Other|qualitative interview|some patient are interviewed.
16072824|NCT02362282|Behavioral|Gait training|Treatment will include coordination exercises and over ground gait training for impaired muscle groups and related gait deficits. The therapy will be provided by a clinical physical therapist specializing in rehabilitation for stroke patients, according to established, conventional guidelines. The protocol was used in the investigators' prior studies, and is designed to restore voluntary control of ankle dorsiflexion during swing phase; hip flexion during swing phase, knee flexion at toe-off, knee flexion during swing phase; knee extension before heel strike; knee control during stance phase; pelvic control during stance phase; and whole body balance control during weight shifting. Newly-learned coordinated movements will be integrated into practice of coordinated gait components. Cognitive rehabilitation will begin with the least difficult aspects of attention control, and progress to the more difficult. Home practice and generalization exercises will be assigned.
16072825|NCT02362282|Behavioral|cognitive training|Cognitive training is designed to enhance attention, intention, executive function, decision making and reaction time. Commercially available computer software will be used, as well as custom cognitive training.
16072826|NCT02362282|Behavioral|Arm training|Treatment will include coordination exercises for reaching and grasping. Activities will include movement of shoulder, elbow, wrist and fingers.
16072827|NCT02362269|Dietary Supplement|Vitamin D|Gelcaps containing 1000, 2500, and 4000 IU of vitamin D3 will be obtained from Tischon corporation (Westbury, NY). The gelcaps will be protected from light and not stored above 25° C. Participants will be instructed to take their vitamin D3 gelcaps with supper daily. Compliance with study supplementation will be documented by pill count at the time of each study visits.
16072828|NCT02362256|Drug|Naltrexone|
16072829|NCT02362256|Drug|Clonidine|
16072830|NCT02362256|Drug|Lorazepam|
16072831|NCT02362243|Other|Experimental Intervention|Participants will perform the back and core exercises that were tested in our previous firefighter study (Mayer, 2015), in addition to their usual physical fitness routine. All participants at a given fire station will receive the same intervention and all interventions will be completed at the fire station. Participants will perform 2 exercise sessions each week (each time they are on duty) throughout the study's 12-month duration. The back and core exercise program consists of 1 set of 5 exercises - 4 core exercises on a floor mat and 1 back extension exercise on a variable angle Roman chair - which will take approximately 10 minutes to complete for each session (Mayer, 2015).
16072832|NCT02362243|Other|Placebo Comparator|Participants will receive a 45-60 minute, one-time educational session, which will be delivered to delivered by an exercise specialist in a 1-on-1 format while the participant is on-duty at the fire station, in addition to their usual physical fitness routine. Content for the educational session on evidence-based guidelines for exercise, physical fitness, and general physical activity will be derived from the American College of Sports Medicine (ACSM) Position Stand - Quantity and Quality of Exercise for Developing and Maintaining Cardiorespiratory, Musculoskeletal, and Neuromotor Fitness in Apparently Healthy Adults: Guidance for Prescribing Exercise (Garber, 2011).
16072833|NCT02362230|Drug|Icotinib|Icotinib 125 mg BID
16072834|NCT02362217|Biological|AdCh3NSmut1|Genetic vaccine against Hepatitis C virus infection
16072835|NCT02362217|Biological|MVA-NSmut|Genetic vaccine against Hepatitis C virus infection
16072836|NCT02362217|Biological|ChAdV63.HIVconsv|Genetic vaccine against HIV-1 infection
16072837|NCT02362217|Biological|MVA.HIVconsv|Genetic vaccine against HIV-1 infection
16072838|NCT02362204|Behavioral|therapeutic education and psychological support|Intervention consists of alternate face-to-face consultations (anticipated duration: 60-90 minutes) and telephone consultations (anticipated duration: 15-30 minutes). All interventions will include: i) a focused assessment of physical and psychological symptoms, ii) information about lung cancer (disease) and its treatment, iii) a review of disease-related and treatment-related side effects and strategies to manage these symptoms, and iv) printed listing and review of available support resources.
16072839|NCT02362191|Device|Alternating Current Stimulator|Transcranial alternating current stimulation (tACS) is a method of noninvasive brain stimulation in which weak electrical current are applied to the scalp in a sine wave pattern to induce cortical oscillations at the frequency at which they are applied.
16072840|NCT02362178|Procedure|Thromboelastography to guide blood products infusion|A TEG has been performed before invasive procedure and blood products infusion has been decided according to TEG parameters as follow: fresh frozen plasma (FFP 10 ml/kg) in case of r time>40 mm and/or platelets (PLTs 10 units/Kg) for MA<30 mm
16072841|NCT02362178|Procedure|Standard of care coagulation tests to guide blood products infusion|Patients received FFP (10 ml/kg) if INR>1.8 and/or PLTS (10 units/Kg) If PLTs count < 50000/μl
16072842|NCT02362165|Drug|Cyclophosphamide|500mg/d,once-weekly,per oral.
16072843|NCT02362165|Drug|Bortezomib|1.3mg/㎡,once-weekly,subcutaneous injection
16072844|NCT02362165|Drug|Dexamethasone|40mg/d,once-weekly,per oral
16072845|NCT02362165|Drug|Doxorubicin|9mg/㎡,d1-4
16072846|NCT02362152|Drug|Ingenol mebutate|Topical field treatment as prescribed by dermatologist
16072847|NCT02362152|Drug|5-fluorouracil|Topical field treatment as prescribed by dermatologist
16072848|NCT02362152|Drug|Imiquimod|Topical field treatment as prescribed by dermatologist
16072849|NCT02362152|Drug|Diclofenac|Topical field treatment as prescribed by dermatologist
16072850|NCT02362139|Drug|The study group|200 pregnant women, 18-45 years old, 37-41 weeks of gestation, in spontaneous labor, which were treated with 80 mg of Intra-muscular (IM) Papverine during the latent phase of labor (cervical dilatation<4cm).
16072851|NCT02362126|Device|Endoscopic full thickness resection (EFTR)|Patients undergo EFTR using the FTRD
16072852|NCT02362113|Other|GI/GL|GI and GL would be categorized as tertile. due to cross-sectional design of this study, intervention would not be applicable.
16072853|NCT02362100|Other|Non operative|non operative treatment
16072854|NCT02362100|Procedure|locking plate surgical fixation|
16072855|NCT02362087|Other|Quality of life and brief pain inventory|blood collection and quality of life questionnaires and a pain medication diary
16072856|NCT02362061|Radiation|3D ultrasound|ultrasound to measure the thickness of the junctional zone at day 21 of the cycle
16072857|NCT02362048|Drug|ACP-196|
16072858|NCT02362048|Drug|ACP-196 in combination with pembrolizumab|
16072859|NCT02362035|Drug|ACP-196|oral
16072860|NCT02362035|Drug|Pembrolizumab|intravenous
16072861|NCT02362022|Drug|Morphine|Group Saline (Group S): Received i.v saline 0.9 % in 10 ml volume (n=30) Group Morphine 1 (Group M1): Received i.v morphine 0.1 mg kg-1 in 10 ml volume (n=30) Group Morphine 2 (Group M2): Received i.v morphine 0.2 mg kg-1 in 10 ml volume (n=30)
16072862|NCT02361983|Device|DLT versus bronchial blockers|Safety and efficacy of the double-lumen tubes (DLT) and bronchial blockers (BB) for lung isolation in patients undergoing thoracic surgery have been extensively studied and most of the results show similar rates of successful placement and lung collapse. DLT and BB are more frequently inserted by anesthetists who are expert in thoracic anesthesia, with dedicated but different training.
16072863|NCT02361957|Dietary Supplement|Ecologic 825|Multispecies probiotic product, 2.5 x10E9 colony forming units per gram, 6 grams a day
16072864|NCT02361957|Dietary Supplement|Placebo|Placebo
16072865|NCT02361944|Drug|Oxygen (normoxia vs. hyperoxia)|
16072866|NCT02361931|Drug|A hydrogel containing erythropoietin|Standard of wound care, which includes initial debridement, wound cleansing, pressure relief, and infection control. RMD-G1 applied daily onto a clean wound at 0.25g per sq.cm. of wound surface. After its application, the wound is covered with a dressing in order to prevent leakage of the gel and contamination of the wound area.
16072867|NCT02361931|Drug|Hydrogel (as a part of SOC)|Standard of wound care, which includes initial debridement, wound cleansing, pressure relief, and infection control. Hydrogel applied daily onto a clean wound at 0.25g per sq.cm. of wound surface. After its application, the wound is covered with a dressing in order to prevent leakage of the gel and contamination of the wound area.
16072868|NCT02361918|Procedure|Colon surgery|
16072869|NCT02361905|Drug|ulipristal acetate|5 mg/day will be administered starting from day 1 of the cycle and up to three months later
16072870|NCT02361905|Drug|Leuprolide acetate|One dose of 11.25 GnRH analogue depot will be administered in the luteal phase of the menstrual cycle (days 21-24)
16072871|NCT02361892|Drug|ulipristal acetate|5 mg/day will be administered starting from day 1 of the cycle for two courses of 3 months each
16072872|NCT02361879|Drug|ulipristal acetate|5 mg/day will be administered starting from day 1 of the cycle and up to three months later
16072873|NCT02361879|Drug|Leuprolide acetate|One dose of 11.25 GnRH analogue depot will be administered in the luteal phase of the menstrual cycle (days 21-24)
16072874|NCT02361866|Biological|GC1107|0.5 ml, Intramuscular, single dose(day0)
16072875|NCT02361866|Biological|Tetanus and Diphtheria(Td vaccine)|0.5ml, Intramuscular, single dose(day0) only applicable step1
16072876|NCT02361853|Other|Exposure: abundance of Immature Myeloid Cells counts in blood samples|
16072877|NCT02361853|Other|Exposure: abundance of Immature Dentritic Cells counts in blood samples|
16072878|NCT02361853|Other|Exposure: abundance of Immature monocytes counts in blood samples|
16072879|NCT02361853|Other|Exposure: abundance of Immature neutrophils counts in blood samples|
16072880|NCT02361827|Procedure|Embryo transfer|For patients in each group, they will have embryo transferred 3 or 5 days after oocyte retrieval.
16072881|NCT02361814|Procedure|The use of amnionic membrane allograft|After the conventional flexor tendon repair, the amniotic membrane will be wrapped around the tendons and its borders will be fixed to the remaining tendon sheath.
16072882|NCT02361801|Drug|Liberal dobutamine protocol|All patients will receive dobutamine at the cardiopulmonary bypass weaning.
16072883|NCT02361801|Drug|Restrictive dobutamine protocol|Patients will receive dobutamine during the first 8 hours after cardiopulmonary bypass weaning only if they have a cardiac index of ≤ 2.5L/min/m2 and at least one sign of tissue hypoperfusion: ScvO2 ≤ 70% and / or urine output < 2 mL/Kg/h despite adequate fluid replacement.
16072884|NCT02361775|Device|Paravertebral catheter|A catheter is placed ultrasound guided at the T5 paravertebral level
16072885|NCT02361775|Device|opioid iv pca|opioid pca consisting of hydromorphone
16072886|NCT02361775|Drug|Ropivacaine|0.2% ropivacaine infused through paravertebral catheter
16072887|NCT02361775|Device|Elastomeric Pump|Elastomeric pump connected to paravertebral catheter
16072888|NCT02361762|Behavioral|Computerized executive control training|"Children will play computerized training games designed to improve executive control skills. Each training activity is structured to achieve a particular type of training related to executive control and/or attention shifting.
~Sessions last for 1 hour each and the intensity of intervention ranges from 5-10 hours. Children will receive training until all levels of all tasks have been passed or 10 hours, whichever happens first. All training exercises have a number of levels, and children progress to the next level by meeting specific criteria for accuracy and/or speed.
~A trainer will be present during all sessions to help children comply with the training demands and to teach skills involved in completing challenging tasks."
16072889|NCT02361749|Drug|Botulinum Toxin|Injection of Botulinum toxin under general anesthesia. Four injections will be given into the anal sphincter into the four quadrants in one session.
16072890|NCT02361749|Procedure|Anal Myectomy|Longitudinal anal myectomy will be performed under general anesthesia as a day case.
16072891|NCT02361736|Drug|Hydroxyethyl Starch|6% Hydroxyethyl Starch(HES) is intravenously given 7.5ml/kg for the first hour of surgery
16072892|NCT02361736|Drug|Lactate Ringers|Lactate Ringers is intravenously administrated at a dose of 7.5ml/kg during the surgery
16072893|NCT02361723|Drug|BGB-290|
16072894|NCT02361723|Drug|BGB-290|
16072895|NCT02361723|Drug|BGB-290|
16072896|NCT02361723|Drug|BGB-290|
16072897|NCT02361723|Drug|BGB-290|
16072898|NCT02361710|Procedure|frozen embryo transfer|comparison of groups according to their serum vitamin D levels on frozen embryo transfer day
16072899|NCT02361697|Other|DTI-MRI|MRI of the brain with special DTI-sequences are performed in each child with multiple sclerosis or clinically isolated syndrome at timepoint of first manifestation and every 6 months in a longterm follow-up of 3 years
16072900|NCT02361684|Behavioral|Blended CBT treatment|Internet based blended CBT depression treatment combines individual face-to-face cognitive behavioural therapy (CBT) with CBT delivered through an Internet based treatment platform with mobile phone components (either integrated in the treatment platform or as a separate system). The core components of the CBT treatment are: (1) psycho-education, (2) cognitive restructuring, (3) behavioural activation, (4) positive psychology, and (5) relapse prevention. These will be delivered over 10 sessions. For this study, the ratio between the number of face-to-face sessions and the number of online module will be 1/3 face-to-face and 2/3 online.
16072901|NCT02361684|Other|Treatment as usual|Treatment as usual (TAU) is defined as the routine care that subjects receive when they are diagnosed with depression in the primary care system. In practice, this means that treatment as usual may vary between patients. We will not interfere with treatment as usual but we will monitor carefully which health care services are utilized by usual care patients using patient records and through self-report
16072902|NCT02361671|Other|Optic Nerve Sheath Diameter using an ultrasound|Optic nerve sheath diameter will be measured by ultrasound preoperatively on the day of surgery, Immediate postoperative period (within 24 hours) or 6-8 weeks after surgery on the follow-up visit.
16072903|NCT02361658|Other|Ultrasonographic of the optic nerve sheath diameter|On both eyes of all subjects in supine position by two investigators.
16072904|NCT02361658|Other|RespirAct™|Carbon dioxide Manipulation by RespirAct™ sequential gas delivery breathing circuit at each CO2 levels (normocapnia, Hypercapnia I and II and hypocapnia).
16072905|NCT02361658|Other|Neck collar|Internal jugular compression using a Neck collar will be applied at each CO2 levels (normocapnia, Hypercapnia I and II and hypocapnia) and ONSD measurements will be done before and after the collar.
16072906|NCT02361645|Drug|Ketorolac 0.5% eyedrops|
16072910|NCT02361632|Dietary Supplement|Coffee with or without milk|Intervention :30 participants were randomized to 3 Groups, 10 persons in each group. All participants fasted 6 hours for solid food before gastric volume was measured by Magnetic Resonance Imagining ( MRI). 2 hours before MRI examination, each participant ingested either 175 ml black coffee, 175 ml coffee with 20% milk or 175 ml coffee with 50% milk in the order defined for the group (arm).
16072911|NCT02361619|Drug|Caffeine|probe
16072912|NCT02361619|Drug|Diclofenac|probe
16072913|NCT02361619|Drug|Esomeprazole|probe
16072914|NCT02361619|Drug|Metoprolol|probe
16072915|NCT02361619|Drug|Midazolam|probe
16072916|NCT02361619|Drug|Dabigatran|probe
16072917|NCT02361619|Drug|Clarithromycin|perpetrator
16072918|NCT02361606|Behavioral|An Internet Cognitive-Behavioral Intervention|We developed a cognitive behavioral program for adolescents with type 1 Diabetes and their parents, that consists of six virtual sessions at https://minustress.com/diabetes/gate.asp.
16072919|NCT02361593|Procedure|assistance of a transparent cap|Patients will receive endoscopic injection of lauromacrogol with assistance of a transparent cap.
16072920|NCT02361593|Procedure|without a transparent cap|Patients will receive routine endoscopic injection of lauromacrogol without use of transparent cap.
16072921|NCT02361580|Other|Diary|Subject keeps diary of recovery
16072922|NCT02361567|Drug|Tramacet|Pain medication commonly used post-operatively
16072923|NCT02361567|Drug|Percocet|Pain medication commonly used post-operatively
16072924|NCT02361554|Device|Medtronic Activa Deep Brain Stimulation System|
16072925|NCT02361541|Procedure|HCV screening|HCV antibody screening, liver function tests, full blood count and HbsAg will performed. Additional blood samples will be taken for further HCV diagnostic work-out (polymerase chain reaction (PCR) and genotyping). For patients with current HCV infection, liver ultrasound, transient elastography - Firbroscan and further lab analysis will be performed.
16072926|NCT02361528|Drug|Sargramostim: Leukine (Genzyme USA)|Leukine: 125 µg/m² daily, subcutaneously, for 5 days.
16072927|NCT02361528|Drug|Placebo|placebo subcutaneously, for 5 days
16072928|NCT02361515|Radiation|Moderate hypofractionated radiotherapy|Moderate hypofractionated radiotherapy of 62Gy in 20 fraction of 3.1Gy.
16072929|NCT02361515|Radiation|Stereotactic radiotherapy|Stereotactic radiotherapy of 37.5Gy in 5 fraction of 7.5Gy.
16072930|NCT02361502|Drug|mirabegron|
16072931|NCT02361502|Drug|placebo|
16072932|NCT02361489|Device|V-Go|Initiation and titration of V-Go® using one of two dose titration algorithms to achieve improved A1C at 4 months.
16072933|NCT02361476|Drug|Clonidine|Injection - during surgery
16072934|NCT02361476|Drug|Placebo|Injection - during surgery
16072935|NCT02361463|Device|3D vision|Laparoscopic simulator training to proficiency under 3D conditions
16072936|NCT02361463|Device|2D vision|Laparoscopic simulator training to proficiency under 2D conditions
16072937|NCT02361450|Device|Retrograde Colonic Irrigation|
16072938|NCT02361450|Other|Usual Care|
16072939|NCT02361437|Dietary Supplement|Vasculera|Vasculera 630 mg b.i.d.
16072940|NCT02361424|Drug|PXT00864|PXT00864 is a fixed-dose combination of baclofen and acamprosate
16072941|NCT02361424|Drug|placebo|
16072942|NCT02361398|Other|the EIT guide the individualized PEEP Setting|the EIT guide the individualized PEEP Setting in the EIT group
16072943|NCT02361385|Other|this is not an interventional study|this is not an interventional study; this is a pilot feasibility study to see whether or not 11CPR28 will be taken up in joints of those known to have active arthritis clinically
16072944|NCT02361372|Other|Placebo|Placebo daily for 6 months
16072945|NCT02361372|Other|CaCO3|CaCO3 daily for 6 months
16072946|NCT02361372|Other|Kefir|Kefir daily for 6 months
16072947|NCT02361359|Other|Psychological questionnaires|
16072948|NCT02361346|Drug|MT-3724 Phase 1|Intravenous dosing M-W-F X 2 weeks; MT-3724 infusion over 2 hours on each dosing day over 28 day initial cycle and then 21 week repeat cycles for up to 5 total cycles.
16072949|NCT02361346|Drug|MT-3724 Phase 2|Intravenous dosing on M-W-F x 2 weeks; MT-3724 infusion over 1 hour on each dosing day over 21 day cycle up to 6 cycles and then can be continued for 6 additional cycles.
16072950|NCT02361333|Behavioral|Teaching Intervention|Patients will be taught how to install and use a remote monitor
16072951|NCT02361320|Procedure|Computed Tomography (CT)|Participants to receive 2 CT scans. One scan performed before the start of chemotherapy, and the other at first restaging visit with oncologist.
16072952|NCT02361320|Behavioral|Questionnaire|Participant to complete the MD Anderson Symptom Inventory for Gastrointestinal cancer (MDASI-GI) questionnaire at baseline visit, and follow up visit. Questionnaires should take about 10 minutes to complete.
16072953|NCT02361307|Procedure|Seamless ADL training|The experimental group receive the seamless ADL training which occupational therapist and nurse work with effective communication and cooperate in dressing and bathing training
16072954|NCT02361307|Procedure|Conventional ADL training|The control group receive the conventional ADL training programme
16072955|NCT02361294|Other|Blood samples|
16072956|NCT02361268|Behavioral|Intradialysis-yoga|The experimental intervention in this study is intra-dialysis yoga. The intra-dialysis yoga protocol consists of yoga instruction and practice being offered three times a week for 12 weeks. Subjects will have the opportunity to participate in 15 to 60 minutes of yoga during dialysis.
16072957|NCT02361268|Behavioral|Educational program|The educational intervention in this study consists of 12 modules of an educational course, Kidney School, developed and maintained by the Medical Education Institute, Inc. Kidney School is a comprehensive, free, educational curriculum for people with kid
16072958|NCT02361255|Other|no intervention|
16072959|NCT02361242|Drug|PXT00864|PXT00864 is a fixed-dose combination of baclofen and acamprosate
16072960|NCT02361216|Drug|Ingenol Mebutate|
16072961|NCT02361216|Other|Vehicle|Vehicle gel
16072962|NCT02361203|Behavioral|Exercise|30 minutes of aerobic exercise on a treadmill at 80% of participant's heart rate reserve.
16072963|NCT02361190|Drug|Testosterone|Administration of 1ml aqueous nasal spray containing 7mg testosterone propionate
16072964|NCT02361190|Drug|Placebo|Administration of 1ml aqueous saline spray
16073278|NCT02358915|Device|FastStart neuromuscular electrical stimulator|
16072965|NCT02361177|Drug|Oxytocin|Intranasal oxytocin is hypothesized to amplify the influence of social norms on unethical behavior.
16072966|NCT02361151|Behavioral|TECH|Weekly newsletter with health information, mobile apps, and self-monitoring materials
16072967|NCT02361151|Behavioral|TECH+|Weekly newsletter with health information, mobile apps, and self-monitoring materials along with theory-based mobile web intervention
16072968|NCT02361138|Drug|SHR3824|
16072969|NCT02361138|Drug|Placebo|
16072970|NCT02361125|Drug|Methylphenidate|5 mg tablet by mouth as needed every 2 hours for participant described significant fatigue. Participants to take a maximum of 20 mg/day, for total of 28 tablets for 7 days.
16072971|NCT02361125|Behavioral|Fatigue Evaluations|Participants to have evaluation of their fatigue, ability to sleep, and will answer a set of general symptom questions at baseline visit, daily while on study drug, and on seventh day of treatment.
16072972|NCT02361112|Drug|pyrotinib combined with capecitabine|
16072973|NCT02361099|Other|Monitoring by SENTINEL application|Patients will connect once a week to SENTINEL application to do a self-evaluation of several symptoms. A CT- scan will be scheduled only when there is an alert of the application
16072974|NCT02361086|Drug|VT-464: given orally once daily in 28 day cycles|VT-464: given orally once daily in 28 day cycles either 5 days or 7 days a week.
16072975|NCT02361060|Drug|Neostigmine|40mcg/kg
16072976|NCT02361060|Drug|Sugammadex|4mg/kg
16072977|NCT02361060|Drug|Atropine|10 mcg/kg
16072978|NCT02361047|Behavioral|Phone Coaching Program|Participants in this group will receive a 10-session nutrition and physical activity program delivered via phone by a health behavior coach to promote healthy lifestyle changes. Participants will also receive standard-of-care physician counseling regarding lifestyle recommendations to achieve/maintain a healthy weight trajectory after cancer treatment.
16072979|NCT02361034|Drug|GRC 27864|
16072980|NCT02361034|Drug|Placebo|
16072981|NCT02361021|Other|- Weaning from mechanical ventilation|
16072982|NCT02361008|Device|TEE-guided perventricular device closure without CBP|Perventricular device closure through minithoracotomy under the TEE-guidance without CBP.The device is an eccentric occluder made by Shanghai Shape Memory Alloy Co.,Ltd in Shanghai,China
16072983|NCT02361008|Procedure|Surgery repair with CBP|Traditional surgery repair under the CBP.
16072984|NCT02360995|Drug|Triclosan/fluoride toothpaste|Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration).
16072985|NCT02360995|Drug|stannous fluoride toothpaste|Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration).
16072986|NCT02360995|Drug|fluoride toothpaste|Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration).
16072987|NCT02360995|Drug|Fluoride Mouthwash|Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time.
16072988|NCT02360995|Drug|cetylpyridinium chloride Mouthwash|Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time.
16072989|NCT02360982|Behavioral|propofol and esmeron(rokuronyum)|All patients were evaluated at postoperative 24th and 72th hours with laboratory tests including hemoglobin, sodium, potassium, BUN, creatinine, total protein, albumin and glucose values in blood samples and delirium tests (CAM and DRS-R-98).
16072990|NCT02360982|Behavioral|marcaine and fentanyl|All patients were evaluated at postoperative 24th and 72th hours with laboratory tests including hemoglobin, sodium, potassium, BUN, creatinine, total protein, albumin and glucose values in blood samples and delirium tests (CAM and DRS-R-98).
16072991|NCT02360969|Other|Examination of the eye|"Before planed surgery, an ophthalmologist measures the patient's visual acuity and realise an oculomotor examination. Measurement the refraction and the axial length of the eye is performed. Photographs wakefulness are performed.
~During surgery, participation in this study does not involve any change in the course of anesthesia and surgery.
~Pictures of the eye will be performed under general anesthesia.
~Timing photos will be dictated by the values of BIS and train-of-four (TOF). Photos will be conducted at different times, with the top given by the anesthetist under the following conditions:
~Deep anesthesia: BIS <50 Deep anesthesia and muscle relaxation: BIS <50 and TOF 0/4"
16072992|NCT02360956|Drug|Olmesartan medoxomil tablets|Dosage must be individualized. The usual recommended starting dose of Benicar is 20mg once daily when used as monotherapy in patients who are not volume-contracted.For patients requiring further reduction in blood pressure after 2 weeks of therapy, the dose of Benicar may be increased to 40 mg. Doses above 40 mg do not appear to have greater effect. Twice-daily dosing offers no advantage over the same total dose given once daily.
16072993|NCT02360956|Drug|Antihypertensive medication (per doctor suggestion)|Any antihypertensive medication alone or in combination.Calcium channel blockers (CCBs),diuretics, beta-blockers, or other antihypertensive medication except ACE inhibitors or ARBs.The drug dose must be individualed.Dosage must be individualized.The patients should take the antihypertensive drugs according to doctors'suggestion.
16072994|NCT02360943|Other|4 blood samples|PK and / or PD measurements during hospitalization
16072995|NCT02360917|Other|Emerging from the Haze|A 6 week psycho-educational class
16072996|NCT02360904|Other|Yoga|The intervention will consist of 12 weekly 60-minute yoga classes taught by a certified yoga instructor with cancer-specific yoga training. Classes will be conducted at the Beth Israel Comprehensive Cancer Center in a closed-group format, and will be offered twice a week. Yoga mats will be provided for each patient. The maximum number of patients attending each class will be 12. The classes will combine physical postures (asanas), breathing (pranayama), and deep relaxation (savasana). We would also encourage patient to practice yoga at home and keep a diary.
16072997|NCT02360891|Other|biomarkers (composite analysis)|biological, imaging, electrophysiological and anatomopathological examinations
16072998|NCT02360878|Device|EndoBarrier Gastrointestinal Liner|Implantation with the EndoBarrier
16072999|NCT02360865|Other|Exercise|
16073000|NCT02360852|Drug|A4250|A4250 once daily
16073001|NCT02360839|Device|EUS-guided fine needle biopsy sampling (EUS-FNB)|Dual sampling with EUS-FNA and EUS-FNB in a randomized order.
16073002|NCT02360826|Drug|Pravastatin|
16073003|NCT02360826|Drug|Simvastatin|
16073004|NCT02360813|Behavioral|Cognitive Remediation Therapy|Fifty-six sessions of principle driven cognitive remediation therapy. Three individual sessions and one group session each week for approximately fourteen weeks.
16073005|NCT02360813|Other|Treatment as usual|Keep getting usual care.
16073006|NCT02360800|Procedure|Spray Fibrin Sealant|Baxter Tisseel (Fibrin Sealant) is sprayed in the mediastinum at the end of the operation afetr routine chest hemostasis protocol has been completed, right before closing the chest.
16073007|NCT02360800|Procedure|Traditional Hemostasis and chest Closure Routine|Routine chest hemostasis and closure protocol (gauzes and inspection till satisfactory according to the surgeon)
16073008|NCT02360787|Behavioral|Energy restriction|
16073009|NCT02360787|Behavioral|Almonds (15% kcal/day)|
16073010|NCT02360774|Drug|Canagliflozin|Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks.
16073011|NCT02360774|Drug|Placebo|Subjects will take one 300mg capsule of canagliflozin or identically dispensed placebo by mouth once daily, for 18 weeks.
16073012|NCT02360761|Procedure|VATS|Patients undergo lobectomy,wedge resection, or anatomical segmentectomy by thoracoscopic surgery or video assisted thoracoscopic surgery.
16073013|NCT02360761|Procedure|Thoracotomy|Patients undergo lobectomy, wedge resection, or anatomic segmentectomy by thoracotomy.
16073014|NCT02360748|Dietary Supplement|Plant based high protein food items|Patients will add high protein plant based food items to their diet
16073015|NCT02360735|Other|Manual Lymphatic Drainage|Manual Lymphatic Drainage (MLD) is a specialized massage technique utilized to decrease various forms of edema. This technique promotes reuptake of interstitial fluid along the pathways of the lymphatic system. This technique promotes healing, decrease swelling, and decrease pain.
16073016|NCT02360735|Other|Physical Therapy|All patients will participate in joint physical therapy classes during their inpatient stay.
16073017|NCT02360722|Other|Oral Nutritional Supplement|Will receive ONS twice a day for 6 months and two nutritional education at baseline and 3 months after intervention
16073018|NCT02360722|Other|Nutritional Education|Two nutritional education courses at baseline and 3 months after intervention
16073019|NCT02360709|Device|CRE8 sirolimus-eluting stent|The CRE8 stent system consists of a sirolimus eluting coronary stent firmly held on the distal end of a semicompliant balloon catheter. This stent is made of cobalt chromium alloy and is coated with a thin carbon film.The outer surface of the stent has dedicated grooves for containing the pharmaceutical formulation, which is composed of the drug sirolimus and a mixture of long chain fatty acids.
16073020|NCT02360683|Other|patients with Parkinson's disease|
16073021|NCT02360670|Other|control imaging|
16073022|NCT02360670|Other|additional multimodal imaging|
16073023|NCT02360657|Drug|JNJ-54861911, 10 mg|JNJ-54861911, 10 mg (2*5 mg tablet) orally once daily for 4 weeks.
16073024|NCT02360657|Drug|JNJ-54861911, 50 mg|JNJ-54861911, 50 mg (2*25 mg tablet) orally once daily for 4 weeks.
16073025|NCT02360657|Drug|Placebo|Placebo matching to JNJ-54861911 tablet orally once daily for 4 weeks.
16073026|NCT02360644|Dietary Supplement|Cholecalciferol|Vitamin D deficient patients, in both Arms, will be administered Cholecalciferol 5,000 IU daily.
16073027|NCT02360631|Drug|Chantix|A drug used to treat nicotine addiction.Chantix is approved by the FDA to be given to help people quit smoking.
16073028|NCT02360631|Drug|Placebo|Health education counseling will be provided to all participants.
16073029|NCT02360618|Drug|Metformin|See Group Description
16073030|NCT02360618|Drug|Simvastatin|See Group Description
16073031|NCT02360605|Behavioral|automated telephone reminder|The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT. ATR will remind the patient of the importance of completing and returning the FIT results and encourage screening completion. There will also be an option where the patient can request another FIT kit be mailed to them, one to hear information on common problems with FIT completion or how to call the clinic if they have questions. Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a friendly letter to remind them that it is time for their annual CRC screening and that a FIT kit will be mailed the following week. During the following week the patients will be mailed the FIT kit with addressed stamped envelope and the educational pamphlet they received at enrollment. For follow-up ATR calls, we will use the same protocol as described for the initial screening. Same procedure for year 3.
16073032|NCT02360605|Behavioral|prevention coordinator|The patients will be contacted at 4 weeks and again at 8 weeks if they have not returned the FIT by a prevention coordinator (PC). PC will call to encourage completion and ascertain any barriers to completion. The PCs will use Health Literacy and motivational interviewing techniques described in the training section to enhance understanding and confidence and reduce ambivalence to completing and returning the FIT. Years 2 and 3: 12 months after patients returned their initial FIT (or if they did not return the FIT, 12 months after enrollment) they will be mailed a friendly letter to remind them that it is time for their annual CRC screening and that a FIT kit will be mailed the following week. During the following week the patients will be mailed the FIT kit with addressed stamped envelope and the educational pamphlet they received at enrollment. For follow-up PC calls, we will use the same protocol as described for the initial screening. Same procedure for year 3.
16073033|NCT02360605|Behavioral|Health literacy appropriate education and demonstration|The Research Assistant (RA) will employ health literacy communication principles in providing a CRC recommendation and brief screening information using the CRC pamphlet and a FIT kit with simplified instructions and accompanying self-addressed, stamped envelope. A scripted message and illustrations will model what the patient needs to do to complete the FIT. The RA will appropriately demonstrate, using the kit, and will suggest patients show the pamphlet and FIT kit to their provider that day and talk to them about screening. Annual screening will be further emphasized at enrollment by giving patients an empowering message about the benefits of completing a FIT annually and telling them they will be mailed a reminder letter and FIT kit and receive outreach phone calls in 12 and 24 months for the next two years as well as a post survey and satisfaction interview over the phone at 6 months.
16073034|NCT02360592|Drug|Entecavir|In arm 1, Entecavir is used for 48 weeks and the follow up 24 weeks as conventional control, In arm 2 and 3, Entecavir is used for 8 weeks.
16073035|NCT02360592|Drug|Interferon alfa-2b|In arm 2 and 3, interferon alfa-2b is used for 48 weeks
16073279|NCT02358902|Device|tDCS|tDCS - DC stimulator, Neurocom, Germany
16073036|NCT02360592|Drug|Interleukin 2|In arm 3, Interleukin 2 is used for 12 weeks
16073037|NCT02360592|Drug|Hepatitis B Vaccine|In arm 3, Hepatitis B Vaccine is used for 48 weeks
16073038|NCT02360579|Biological|Lifileucel|A tumor sample is resected from each patient and cultured ex vivo to expand the population of tumor infiltrating lymphocytes. After lymphodepletion, patients are infused with Lifileucel followed by IL-2.
16073039|NCT02360566|Behavioral|Participatory Video Intervention for Early Psychosis|The Participatory Video intervention consists of 12 semi-structured, 2 hour group workshops over the course of a 6-month time period. Through facilitated discussion, participants will learn how to effectively work collaboratively as a member of the video production team. Together, they will choose what story of their shared experience with psychosis they would like to tell through documentary-video and how they plan to share it. Participants will be trained to operate all equipment required to bring their vision to life. Individuals will also have the opportunity, during the Participatory Video process, to create and share their own video clips, independent of the group, allowing participants to share their own video-narrative with others (friends, family members, public) as a means of engaging in dialogue around their personal experience with psychosis.
16073040|NCT02360553|Behavioral|ObeseGO!|The intervention group were received the obeseGO! intervention which is an internet-based intervention. The participants and the parents who are randomly chosen to enroll in this intervention group were provided with the ObeseGO! website. The website was accessed at www.obesego.com. The website consists of various informations on healthy lifestyle, diet and ways to overcome obesity.
16073041|NCT02360553|Behavioral|Pamphlets material|The control group will be given pamphlets material on diet and physical activity.
16073042|NCT02360540|Other|Gestalt estimation|
16073043|NCT02360514|Drug|Hantavax injection|Intramuscular or hypodermic injection of 0.5ml per time twice at interval of 1 month for adults. For more immune, inoculate muscle or subcutaneous once mor 12 months after the completion of the initial immune
16073044|NCT02360501|Drug|Docetaxel|75mg/㎡,d1
16073045|NCT02360501|Drug|Cisplatin|25mg/㎡,d1-3
16073046|NCT02360501|Drug|Capecitabine|2000mg/㎡,d1-14
16073047|NCT02360488|Device|Telerehabilitation Therapy|18 days of supervised sessions via videoconference and 18 days of unsupervised sessions.
16073048|NCT02360488|Behavioral|In-Clinic Therapy|18 days of therapist supervised sessions and 18 days of unsupervised in home sessions.
16073049|NCT02360475|Biological|RSV vaccine GSK3003895A (formulation 1)|Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
16073050|NCT02360475|Biological|RSV vaccine GSK3003898A (formulation 2)|Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
16073051|NCT02360475|Biological|RSV vaccine GSK3003899A (formulation 3)|Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
16073052|NCT02360475|Biological|Boostrix|Single dose administered intramuscularly at Day 0 in the deltoid region of the non-dominant arm
16073053|NCT02360462|Device|Active tDCS|The stimulation will be administered with a pair of surface electrodes, sponge coated, soaked in saline. A battery-powered constant current stimulator will be used for this purpose (tDCS device). The stimulation is performed by placing the anodal electrode in the primary motor cortex (M1) and the cathodal one in the contralateral supraorbital area and it will use a 2 mA (milliampere) current.
16073054|NCT02360462|Device|Sham tDCS|The sham tDCS consists in the same montage of the active tDCS, but the device is turned off 30 seconds after stimulation starts (without letting the patient notice it). The rest of the montage is kept identical to the active one during the 20 minutes session
16073055|NCT02360449|Behavioral|Social Initiation Motivation Intervention|The SIMI approach under investigation uses behavioral strategies based in Applied Behavior Analysis and Pivotal Response Treatment to motivate children with ASD to initiate to peers. The adult arranges the play environment in order to promote cooperation and facilitates frequent prompting and reinforcement from peers, thereby enhancing the reward value of peer interactions.
16073056|NCT02360423|Device|CRE8 sirolimus-eluting stent|The CRE8 stent is a flexible implantable device that can be expanded using a PTCA catheter. The stent is made of Cobalt chromium alloy and is coated with i-carbofilm.The outer surface of the stent has dedicated grooves for containing the pharmaceutical formulation, which is composed of the drug sirolimus and a mixture of long chain fatty acids.
16073057|NCT02360423|Device|RESOLUTE zotarolimus-eluting stent|The RESOLUTE stent is a flexible implantable device that can be expanded using a PTCA catheter. The stent is made of Cobalt chromium tungsten alloy. It has been approved by CFDA in 2009 and commercially available in Chinese market
16073058|NCT02360410|Behavioral|Check Yourself App with Feedback|
16073059|NCT02360397|Drug|ranolazine|Ranolazine 1000 mg tablet twice daily for 30 days
16073060|NCT02360384|Drug|Linaclotide|Linaclotide 290mcg po od in all patients with irritable bowel syndrome with constipation.
16073061|NCT02360384|Dietary Supplement|FODMAP diet|Patients with irritable bowel syndrome with alternating bowel habit will be commenced on the either the low FODMAP diet or a control healthy eating diet.
16073062|NCT02360371|Drug|Within-subject test of blinded study medication|Within-subject double-blind, randomized, placebo-controlled, residential human abuse potential study. All participants received 4mg oral hydromorphone on study day 2 and a subset continued into the randomized portion for study days 3-5 wherein they received placebo, 2mg hydromorphone, and 8mg hydromorphone in randomized order. Only one dose was administered per day and following randomized all participants received each dose in random order. Outcomes were collected during 8-hour residential-based sessions and included metrics of FDA human abuse potential testing as well as secondary outcomes of laboratory pain testing, subjective reports of drug effects, and cognitive performance, evaluated as a function of study medication condition. Participants were genotyped for rs-1799971 status and results were analyzed as between-group comparisons based upon genotype.
16073063|NCT02360358|Drug|Tiscover|two step procedure, week 0 and week1. Dosage depends on wound size.
16073064|NCT02360358|Other|AS210|two step procedure, week 0 and week1. Dosage depends on wound size.
16073065|NCT02360345|Drug|ONX-0801|
16073136|NCT02359695|Drug|Growth Hormone|A dose of 0.5 IU of growth hormone will be administered daily from the first day of the agonist until the day of hCG administration
16073137|NCT02359682|Other|No intervention|No Intervention
16073138|NCT02359669|Behavioral|StimuLearn Intervention|"StimuLearn apps
~Cognitive questionnaires"
16073066|NCT02360332|Behavioral|Project SEARCH plus ASD Supports|Project SEARCH program (Rutkowski, Daston, Kuiken, and Riehle, 2006) is a work based learning model for high school transition that was developed at Cincinnati Children's Hospital Medical Center. The model provides complete immersion in the workplace. Students spend their entire school day at the workplace for a full school year. Consistent with principles of work based learning, Project SEARCH facilitates the development of a broad range of high-quality jobs within the employer organization and provides over 700 of supervised work experience. The model also relies on the intensive application of supported employments strategies (task analysis and customization, systematic instruction, ongoing support, etc.) to allow the participation of individuals with extensive support needs.
16073067|NCT02360319|Drug|Any FDA approved antipsychotic agent|Investigators are free to choose the most appropriate treatment for their clients
16073068|NCT02360319|Drug|aripiprazole long acting injectable formulation|
16073069|NCT02360306|Procedure|Endobronchial Ultrasound|Endobronchial ultrasound bronchoscopy with potential transbronchial needle aspiration, transbronchial forcep biopsy, brushing, or radial endobronchial ultrasound
16073070|NCT02360293|Behavioral|Stay Strong w/coaching|Pts randomly placed in the Stay Strong w/coaching group receive an app-mediated physical activity intervention. Pts are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly and will receive tailored push notifications. Each week the pt will receive a new automatically calculated personalized physical activity goal. Stay Strong coaches will call pts up to 3 times in the first 6-8 weeks of the study to help pts meet physical activity goals including problem solving support. Pts will also be reminded to follow-up with their healthcare provider as needed for the remainder of the 12-month program.
16073071|NCT02360293|Behavioral|Stay Strong|Pts randomly placed in the Stay Strong arm are asked to wear a physical activity monitoring device and weigh regularly using a Bluetooth scale while participating in the study. Pts will be asked to upload the device data at least weekly. Pts will have access to a standard app-mediated intervention that is linked to the wearable device.
16073072|NCT02360280|Drug|ketamine|sedative
16073073|NCT02360280|Drug|midazolam|sedative
16073074|NCT02360254|Drug|Insulin degludec|Once daily injection of insulin degludec
16073075|NCT02360241|Device|Robot|Use of the robot to locate the fictional needle
16073076|NCT02360228|Device|tACS (alpha)|
16073077|NCT02360228|Device|tDCS|
16073078|NCT02360215|Radiation|Whole brain radiation therapy with hippocampal avoidance|Intensity modulated radiation therapy (IMRT) 30 Gy in 10 fractions once per day, 5 days per week for approximately two week; starting within 21 calendar days after randomization.
16073079|NCT02360215|Drug|Memantine|Given PO daily during and after radiation therapy for a total of 24 weeks. Week 1: 5 mg in the AM, none in the PM; Week 2: 5 mg in the AM, 5 mg in the PM; Week 3: 10 mg in the AM, 5 mg in the PM; Weeks 4-24: 10 mg in the AM, 10 mg in the PM. Should start the same day as radiation therapy, at latest before the fourth radiation treatment.
16073080|NCT02360215|Radiation|Whole brain radiation therapy|Whole brain radiation therapy (WBRT) 30 Gy in 10 fractions once per day, 5 days per week for approximately 2 weeks
16073081|NCT02360202|Procedure|Impedance analysis|"Impedance analysis in patient with Bullous pemphigoid disease treated with clobetasol propionate.
~impedance analysis includes : fat measures, lean body mass, total body water, extracellular water phase angle"
16073082|NCT02360202|Drug|Clobetasol Propionate cream treatment|clobetasol propionate treatment initiated following French recommendations
16073083|NCT02360176|Procedure|Sleeve gastrectomy single port|Bariatric surgery: one incision of 2.5 to 3 cm
16073084|NCT02360176|Procedure|Sleeve gastrectomy multi trocar|Bariatric surgery: 4 to 7 incisions of 1 to 2 cm
16073085|NCT02360163|Procedure|Traditional Landmark Technique (TLT)|
16073086|NCT02360163|Device|ultrasound guided peripheral intravenous access (USGPIVA)|
16073087|NCT02360150|Radiation|second propeller arm scanner|The experimental procedure is to conduct a second helical scanner strictly centered on the heart, 10 minutes after the first helix without inject contrast medium, to assess late enhancement.
16073088|NCT02360124|Drug|silver diammine fluoride|topical application of the SDF solution onto tooth root surfaces
16073089|NCT02360124|Other|Water as placebo|topical application of water as a placebo in the control arm
16073090|NCT02360124|Other|saturated potassium iodide solution|topical application of SDF solution followed by KI solution onto tooth root surfaces
16073091|NCT02360111|Drug|Cyclophosphamide|
16073092|NCT02360098|Other|Emergence from Anesthesia|There are no study related interventions in this study and perioperative care of these patients will be as per our standard practice The only study related protocol would be collecting the data on the emergence from anesthesia. The data will be collected from the time of turning off the anesthetic agents till the discharge from recovery room. Data collected include, vital signs, Glasgow coma scale( GCS), and Riker agitation- sedation score.. The patients will be assessed every 5 minutes for the first 30 minutes and every 10 minutes for the next 60 minutes.
16073093|NCT02360059|Drug|Metformin|Metformin dose starts at 500 mg daily for 5 days, followed by 500 mg twice daily for 5 days, followed by 1,000 mg twice daily for 2 days. Participants reach required study medication dose of 2,000 mg daily 2 days prior to commencement of Paclitaxel therapy and continue this dose for remainder of intervention.
16073094|NCT02360059|Other|Placebo|Participants take placebo by mouth twice daily starting 12 days before, and 12 weeks during Paclitaxel treatment.
16073095|NCT02360059|Behavioral|Questionnaires|Questionnaires completed about numbness and/or symptoms about 2 weeks before start of Paclitaxel, 1 -2 days before Paclitaxel, every week while taking Paclitaxel, and at end of study visit. At week 12, questionnaire completed regarding satisfaction with Paclitaxel.
16073096|NCT02360059|Other|Sensory and Fine-Motor Tests|Three sensory and fine-motor tests completed 2 weeks before Paclitaxel, every 3 weeks while taking Paclitaxel, and at end of study visit.
16073097|NCT02360046|Drug|Hydrocortisone|Established Hydrocortisone replacement therapy plus Hydrocortisone (10mg/day)
16073098|NCT02360046|Drug|Placebo|Established Hydrocortisone replacement therapy plus Placebo (0mg Hydrocortisone)
16073099|NCT02360033|Behavioral|Systemic Therapy for Social Anxiety Disorder|
16073100|NCT02360033|Behavioral|Cognitive Behavioral Therapy for Social Anxiety Disorder|
16073139|NCT02359669|Behavioral|Without StimuLearn intervention|Cognitive Questionnaires
16073101|NCT02360020|Device|XLimus|Techniques attempted for facilitating stent delivery in such a complex lesions are: maximize guide catheter support, optimize predilatation of the stenosis, use of a stiffer guidewire. Specific tricks include: a) buddy-wire; anchoring balloon; GuideLiner catheter. In case of severe calcification, rotational atherectomy was electively performed with the Rotablator® system (Boston Scientific Corporation, Natick, MA, U.S.A.). Following stent implantation, postdilatation is performed in all instances with a non-compliant balloon
16073102|NCT02360007|Drug|Interim Buprenorphine Treatment (IBT)|"The Interim Buprenorphine Treatment (IBT) includes:
~Buprenorphine (BUP)
~Computerized adherence monitoring (CAM): BUP will be dispensed via a portable device that makes each day's dose available only at a predetermined time.
~Mobile health clinical support: An Interactive Voice Response (IVR) system to deliver clinical support
~Urinalysis and adherence monitoring with participants contacted via IVR for random call-backs
~HIV+Hepatitis Education delivered via iPad"
16073103|NCT02359994|Device|PerClot Polysaccharide Hemostatic System|During the intraoperative period, the subject will be evaluated for bleeding; only those who meet the intraoperative inclusion criterion will be enrolled into the study. After confirmation of the intraoperative eligibility criteria, the subject will be randomized to receive an adjunct application of PerClot or the control device. The prescribed hemostatic agent will be applied according to its Instructions for Use.
16073104|NCT02359994|Device|Arista AH|During the intraoperative period, the subject will be evaluated for bleeding; only those who meet the intraoperative inclusion criterion will be enrolled into the study. After confirmation of the intraoperative eligibility criteria, the subject will be randomized to receive an adjunct application of PerClot or the control device. The prescribed hemostatic agent will be applied according to its Instructions for Use.
16073105|NCT02359981|Behavioral|MyBehavior|The intervention automatically provides personalized suggestions based on users behavior and user context. Suggestions relates to users life and how often they have done them in the past. Since the suggestions relate to users' lives, they are easy to follow.
16073106|NCT02359981|Behavioral|Generic suggestions|A nutritionist and an exercise trainer jointly created 45 food and exercise suggestions based on guidelines posted by the NIH. These suggestions ask users to walk for 30 minutes or eat healthier foods. These suggestions however doesn't personalize to users daily behavior into account.
16073107|NCT02359981|Device|Smartphone|An Android Smartphone with operating system version higher than 2.2
16073110|NCT02359955|Device|zero degree teeth|zero degree teeth complete denture was first prescribed to patients in group 1 while patients in group 2 were treated with anatomic teeth complete denture
16073111|NCT02359955|Device|anatomic teeth|when anatomic teeth complete denture was prescribed to patients in group 1, patients in group 2 were treated with zero degree teeth complete denture
16073112|NCT02359942|Drug|Citric acid|Giving the citric acid (4g) solving in 200 ml of water before UBT
16073113|NCT02359929|Biological|Autologous mesenchymal stromal cells (MSCs)|Infusion of MSCs delivered to each patient will depend on their weight and assigned dose level. The maximal individual dose of MSCs any patient will receive is 2 x 1000000 cells/kg.
16073114|NCT02359916|Other|Time delays on delivery of less healthy snacks|
16073115|NCT02359916|Other|25%/$0.25 discount on healthy snacks|
16073116|NCT02359916|Other|25%/$0.25 tax on less healthy snacks|
16073117|NCT02359903|Drug|Infliximab (BCD-055)|infliximab is a chimeric monoclonal antibody against tumor necrosis factor alpha
16073118|NCT02359903|Drug|Infliximab (Remicade)|
16073119|NCT02359890|Device|THERMOCOOL® SMARTTOUCH® (RF ablation treatment)|Radiofrequency Ablation Treatment
16073120|NCT02359877|Drug|BCD-054|
16073121|NCT02359877|Drug|Rebif|
16073122|NCT02359877|Drug|Avonex|
16073125|NCT02359851|Biological|Pembrolizumab|Given IV
16073126|NCT02359851|Other|Laboratory Biomarker Analysis|Correlative studies
16073127|NCT02359838|Other|Baseline Geriatric Screening/Assessment|All patients receive baseline geriatric screening/assessment by a research assistant to determine frailty status.
16073128|NCT02359838|Other|Geriatrician Co-Management|A board-certified geriatrician embedded in the oncology clinic will co-manage patients randomized to this arm.
16073130|NCT02359799|Device|IntelliStretch|The impaired ankle of the participants are trained 3 times a week for 6 weeks in the lab or at home. The participants use the portable robotic device to stretch the ankle and increase range of motion (ROM). Then subjects use their gained ROM immediately in the active movement training to play video games and improve motor control.
16073131|NCT02359760|Procedure|Piezocision|Flapless corticotomies
16073132|NCT02359747|Genetic|Polymerase Chain Reaction and Whole Genome Amplification|Polymerase Chain Reaction and Whole Genome Amplification
16073133|NCT02359734|Other|Smart pump safety Intervention bundle for improving IV medication administration process with smart pump|Smart pump safety intervention bundle includes three components--1) eliminating unauthorized medications; implement standardized discontinuation policy of medications, implement standardized keep vein open rates and keep vein open rate order sets, and implement standardized verbal order practice. 2) Implement standardized intravenous(IV) labeling and IV tubing labels. 3) Implement standardized drug library lists and drug library use policies
16073134|NCT02359721|Drug|tablet clarithromycin 500 mg (Clarino-500) orally|orally
16073135|NCT02359708|Procedure|Surgical hand disinfection.|Bacterial recolonization
16073140|NCT02359656|Procedure|surgical treatment|C1-C1 arthrodesis
16073141|NCT02359656|Other|non operative treatment for odontoid non unions|specific non operative treatment protocol
16073142|NCT02359643|Drug|Aspirin|"This study was conduct to investigate the role of high dose aspirin in acute stage of KD via a multi-center randomized control trail, and we plan to achieve the followings in the coming 4 years:
~Enroll 300 KD patients from multiple medical centers of Taiwan and China in 4 years. Randomize group patients as group 1: with high dose aspirin (more than 30/mg/kd/day) until fever subsided and shift to low dose aspirin (3-5mg/kg/day, N=150); and group 2: without high dose aspirin during acute febrile stage, only use low dose aspirin (N=150).
~Compare data including fever days, admission duration, laboratory data (CBC/DC, GOT/GPT, BUN/Cr, Alb, ESR, CRP, 2D echo), IVIG treatment response and CAL formation rate (followed at least 1 year)."
16073143|NCT02359630|Device|EasyTube|Insertion for ventilation
16073144|NCT02359630|Device|Endotracheal tube|Insertion for ventilation
16073145|NCT02359617|Drug|insulin delivery|Subcutaneous insulin (100 U/ml, NovoRapid®; Novo Nordisk, Bagsvaerd, Denmark) delivery with an insulin pump (Vibe-TM; Animas Corp., West Chester, PA, USA) and an insulin infusion cannula (SOF-SET MICRO QR 6mm; Medtronic MiniMed, USA) placed at the same site as the continuous glucose sensor.
16073146|NCT02359617|Device|glucose sensing|Glucose sensing with a continuous glucose sensor (Dexcom G4 Platinum Sensor; Dexcom Inc., San Diego, USA) placed at the site of subcutaneous insulin delivery.
16073147|NCT02359604|Drug|PPI therapy|"PPI therapy (medication has FDA approval) for 8 weeks in children with proven GERD.
~The medication used (esomeprazole) in this trial is approved by the FDA"
16073148|NCT02359604|Procedure|Stool sample|Stool sample will be obtained before initiation of PPI (before PPI therapy)
16073149|NCT02359604|Procedure|Stool sample|Stool sample will be obtained 4 weeks after initiation of PPI (under PPI therapy)
16073150|NCT02359604|Procedure|Stool sample|Stool sample will be obtained 8 weeks after termination of PPI therapy (after PPI therapy).
16073151|NCT02359591|Other|text-based or multimedia|subjects fills in a questionnaire regarding whether the child meets the developmental milestones for his/her developmental age.
16073152|NCT02359578|Drug|Indocyanine Green|Subcutaneous injection of Indocyanine Green in the first interdigital space of the studied arm
16073161|NCT02359552|Drug|Rasagiline|
16073162|NCT02359552|Drug|Placebo|
16073163|NCT02359539|Procedure|Regenerative therapy|Periosteal pedicle, Platelets rich fibrin
16073164|NCT02359526|Drug|IlUVIEN|All patients will receive ILUVIEN 190 micrograms intravitreal implant in applicator with an initial release rate of 0.2 microgram per day. The implant will be administered by injection according to the method of administration defined in the SmPC (ILUVIEN SmPC). Only one eye of each patient will be treated with ILUVIEN.
16073165|NCT02359513|Drug|Antidepressants|bulimic patients are treated during 3 months
16073166|NCT02359513|Drug|Positron Emission Tomography (PET)|PET scan using [18F]MPPF is performed before and after (3 months)antidepressant treatment
16073167|NCT02359500|Drug|68Ga-DOTATOC PET|68Ga-DOTATOC as a diagnostic PET/CT imaging agent for the detection of NETs, mainly carcinoid tumors.
16073168|NCT02359487|Behavioral|Alcohol-HIV Risk Reduction Counseling|The intervention consists of a 1-hour individual counseling session relating to alcohol consumption and HIV sexual risk behaviors. Intervention counselors will assess alcohol-related sexual risk behaviors through the use of job aids that include a flip chart, guided scripts, activities, role plays, and a take home booklet. Counselors use motivational interviewing and interactive activities to discuss alcohol and HIV myths and facts, participants personal risk behaviors, and a decision-making activity that assists participants in weighing the pros and cons of engaging in risky behavior. Counselors also facilitate role plays to improve communication skills in risky situations, as well as a condom demonstration and skills session, and goal setting. In addition, men in the intervention arm will also receive two cell phone text messages 1-month and 4-months following enrollment to reiterate risk reduction messages.
16073169|NCT02359487|Behavioral|Placebo Intervention|Participants assigned to the control arm will be given a general alcohol information booklet and an alcohol abuse support services brochure. The alcohol information booklet contains information about responsible drinking, signs and symptoms of alcohol abuse, advice and guidance to reduce alcohol intake, and resources for assistance. The alcohol support services brochure contains times, dates, and locations of peer support and counseling services in the Windhoek region.
16073170|NCT02359474|Drug|Trabectedin|
16073171|NCT02359474|Genetic|DNA double-strand breaks|"The rationale for combining Tr and RHT is based on immune mechanisms induced by local heating of which are independent of the anti-tumor effects of Tr. Recent results demonstrate that an acute inflammation at the site of the heated tumor area and danger signals are responsible for immune reactions against tumor and metastases (Frey 2012). Abscopal effects after local radiation of tumors with response of distant metastases are induced by similar mechanisms like heat stress (Formenti 2013, Golden 2015). The long-term results for soft-tissue sarcoma are consistent with abscopal effects induced by RHT in a randomized trial compared to chemotherapy alone (Issels 2018)."
16073172|NCT02359461|Device|Combination pulsatile Stendo3|
16073173|NCT02359448|Drug|Melatonin|An open label clinical trial of sustained-release Melatonin 2mg once daily for 6 weeks.
16073174|NCT02359435|Drug|Reverse hybrid therapy|pantoprazole 40 mg b.d., amoxicillin 1 g b.d., clarithromycin 500 mg b.d. and metronidazole 500 mg b.d. for the first 7 days, followed by pantoprazole 40 mg b.d. and amoxicillin 1 g b.d. for another 5 days
16073175|NCT02359435|Drug|Standard triple therapy|pantoprazole 40 mg b.d., clarithromycin 500 mg b.d., and amoxicillin 1 g b.d. for 12 days
16073218|NCT02359175|Drug|Bupivacaine in epidural catheter|Bupivacain to be given in epidural catheter
16073219|NCT02359175|Drug|Fentanyl in epidural catheter|Fentanyl to be given in epidural catheter
16073176|NCT02359422|Behavioral|Media Aware-Sexual Health|10-lesson middle school, comprehensive sexual health media literacy education program. Each lesson take approximately 50 minutes to teach and will be taught every school day for 2 weeks.
16073177|NCT02359409|Device|goggle balloon|Colonoscopy will be performed using the water immersion technique.
16073178|NCT02359409|Other|water immersion only|Colonoscopy will be performed using a goggle balloon at the tip of the scope with water immersion technique.
16073179|NCT02359396|Drug|MZRW|MZRWs is composed of Fructus Cannabis (HuoMaRen), Radix et Rhizoma Rhei (DaHuang), Radix Paeoniae Alba (BaiShao), Semen Armeniacae Amarum (KuXingRen), Fructus Aurantii Immaturus (ZhiShi) and Cortex Magnoliae Officinalis (HouPo). All MZRW granules will be prepared by PuraPharm International (H.K.) Limited. The entire manufacturing process, from authenticating the raw materials to the final products, is in strict compliance with the standards of Good Manufactory Practice (GMP) and Chinese Pharmacopoeia.
16073180|NCT02359383|Other|Chest physiotherapy|Depending on the location of the pleural effusion different techniques are performed: 1. Postural control techniques; 2. Secretions drainage techniques; 3. Thoracic expansion techniques; 4. Diaphragmatic mobility techniques.
16073181|NCT02359370|Drug|Lidocaine|Lidocaine 2 mg/kg was administered through continuous infusion, immediately before induction of anesthesia
16073182|NCT02359370|Drug|Magnesium Sulphate|Magnesium Sulphate 30 mg/kg was administered through continuous infusion, immediately before induction of anesthesia
16073183|NCT02359357|Drug|FDL169|
16073184|NCT02359357|Drug|Placebo|
16073185|NCT02359344|Drug|CNV1014802|
16073186|NCT02359344|Drug|Placebo|
16073187|NCT02359331|Procedure|H. pylori culture and antimicrobial susceptibility testing|"This intervention will be performed in 7 days tailored therapy group.
~All the patients who enrolled in this arm, they will be received endoscopy guided biopsy procedure. Minimum inhibitory concentrations (MICs) were determined by the agar dilution method. Amoxicillin, clarithromycin, metronidazo, tetracycline and moxifloxacin for the H. pylori isolates were examined by use of the serial two fold agar dilution method"
16073188|NCT02359331|Drug|14 days empirical bismuth quadruple therapy (Proton pump inhibitor)|"Giving the 14 days PBMT regimen as 2nd rescue therapy
~Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d."
16073189|NCT02359331|Drug|Metronidazole|
16073190|NCT02359331|Drug|Tetracycline|
16073191|NCT02359331|Drug|tripotassium dicitrate bismuthate|
16073192|NCT02359331|Drug|7 days tailored therapy Proton Pump Inhibitor|
16073193|NCT02359331|Drug|Moxifloxacin|
16073194|NCT02359331|Drug|Amoxicillin|
16073195|NCT02359318|Procedure|Resin infiltration|Resin infiltration is done according to manufactures´ instructions after de-bonding of old brackets and prior bonding of new brackets.
16073196|NCT02359318|Procedure|Bonding and debonding of brackets.|Brackets (Gemini metal brackets (3M Unitek) are bonded and de-bonded by one clinician (Roberto Vogel) and using the same bonding and de-bonding techniques and materials for all patients. All brackets were finally de-bonded at the end of the treatment, with silicon impressions taken before adhesive removal.
16073197|NCT02359305|Drug|Acetaminophen|Acetaminophen given by IV
16073198|NCT02359305|Drug|Acetaminophen|Acetaminophen suppository given rectally
16073199|NCT02359292|Drug|CHF 5993 HS 200/6/25 pMDI|
16073200|NCT02359292|Drug|CHF 5993 MS 100/6/25 pMDI|
16073201|NCT02359292|Drug|CHF 5993 HS 200/6/25 pMDI + Charcoal Block|
16073202|NCT02359292|Drug|CHF 5993 MS 100/6/25 pMDI + Charcoal Block|
16073203|NCT02359292|Drug|Placebo pMDI|
16073204|NCT02359279|Device|Sodium iodide|Comparison of control radiographs made before application of sodium iodide and test radiograph after application.
16073205|NCT02359266|Dietary Supplement|Vitamin D|Given to patients with existing vitamin D deficiency
16073206|NCT02359253|Other|Passive stretching|Prior to active training, subjects will be passively move their arm or hand by IntelliArm or the hand robot within preset ranges of motion.
16073207|NCT02359253|Other|Passive movement|Prior to active training, subjects will be passively move their arm or hand by IntelliArm or the hand robot only within ranges that produce no to very minimal forces.
16073208|NCT02359253|Other|IntelliArm|During the active training, subjects will be asked to actively move their arm while supported with IntelliArm robot to interact with virtual targets and objects. The IntelliArm may provide resistance or assistance.
16073209|NCT02359253|Other|Hand robot|During the active training, subjects will be asked to actively open and close their hand with the hand robot on while participating in task oriented occupational therapy focused on grasp and release tasks. The hand robot may provide resistance or assistance.
16073210|NCT02359240|Procedure|therapy according to SSC guidelines and muscle biopsy|Septic patients will be treated according to the international guidelines for management of severe sepsis and septic shock 2012. Skeletal muscle biopsies, blotted free from blood, are frozen within 30 seconds in liquid nitrogen, and stored in liquid nitrogen until processing.150-300 mg muscle (wet weight) was routinely obtained , which is more than sufficient for the analyses proposed, with some muscle remaining for any additional validation assays that may arise during the course of the research. Muscle will be processed either for isolation of mRNA/microRNA or protein
16073211|NCT02359240|Procedure|standard surgery for femoral fracture and muscle biopsy|Patients with femoral fracture will under standard surgery for fracture fixation. Percutaneous needle muscle biopsies will be performed. Skeletal muscle biopsies, blotted free from blood, are frozen within 30 seconds in liquid nitrogen, and stored in liquid nitrogen until processing.150-300 mg muscle (wet weight) was routinely obtained , which is more than sufficient for the analyses proposed, with some muscle remaining for any additional validation assays that may arise during the course of the research. Muscle will be processed either for isolation of mRNA/microRNA or protein
16073212|NCT02359227|Drug|Cenderitide|Cenderitide is a dual receptor natriuretic peptide.
16073213|NCT02359214|Dietary Supplement|Vitamin D3|5000IU (125mcg) vitamin D3 tablet daily over 8 weeks (56 days).
16073214|NCT02359214|Other|Placebo|100% Lactose tablet daily over 8 weeks (56 days).
16073215|NCT02359201|Drug|V0018|Oromucosal - Single dose
16073216|NCT02359201|Drug|Placebo|Oromucosal - Single dose
16073217|NCT02359188|Device|Transcutaneous vagal nerve stimulation|4 hours of transcutaneous vagal nerve stimulation
16073220|NCT02359175|Drug|Placebo (for Bupivacain and Fentanyl i epidural catheter)|Saline to be given in epidural catheter
16073221|NCT02359175|Drug|Oral Paracetamol|Paracetamol to be given orally
16073222|NCT02359175|Drug|Oral NSAID|NSAID to be given orally
16073223|NCT02359175|Drug|Oral opioids|Opioids to be given orally
16073224|NCT02359175|Drug|Placebo (for oral opioids)|Placebo tablets to be given instead of oral opioids
16073225|NCT02359162|Drug|Gemcitabine|gemcitabine :1250mg/m2 (ivdrip) on days 1
16073226|NCT02359162|Drug|Oxaliplatin|oxaliplatin :85 mg/m2 (ivdrip) on day 1
16073227|NCT02359162|Drug|Pegaspargase|pegaspargase : 2500 IU/m2 (intramuscular injection)
16073228|NCT02359162|Drug|Etoposide|50 mg/m 2 /day 24 h continuous infusion on days 1-4
16073229|NCT02359162|Drug|Vincristine|0.4 mg/m 2 /day 24 h continuous infusion on days 1-4
16073230|NCT02359162|Drug|Doxorubicin|10 mg/m 2 /day 24 h continuous infusion on days 1-4
16073231|NCT02359162|Drug|Cyclophosphamide|cyclophosphamide 750 mg/m2 /day over 15 min intravenously on day 5
16073232|NCT02359162|Drug|Prednisone|60 mg/m 2 /day 60 mg/m 2 /day on days 1-5
16073233|NCT02359162|Radiation|IMRT|IMRT is delivered using 6-8 MeV linear accelerator using intensity-modulated radiation treatment planning. The radiation dose is 50 grays (Gy) in 25 fractions.
16073234|NCT02359149|Procedure|intravitreal injections given by a nurse|
16073235|NCT02359149|Procedure|intravitreal injections given by a physician|
16073236|NCT02359149|Procedure|Intravitreal injections|
16073237|NCT02359149|Drug|Anti-VEGF agents|
16073238|NCT02359136|Procedure|local infiltration anesthesia using Ropivacaine and Epinephrine|150 ml Ropivacaine 2mg/ml + 0,5 ml Epinephrine 1 mg/ml: The first 50 ml will be injected in the periacetabular tissue after insertion of the acetabular component. After insertion of the femoral component, 50 ml will be inserted in the gluteus muscles and the proximal part of the iliotibial tract. The last 50 ml will be inserted in the subcutaneous layer.
16073239|NCT02359136|Procedure|local infiltration anesthesia using saline|150 ml 0,9% saline: The first 50 ml will be injected in the periacetabular tissue after insertion of the acetabular component. After insertion of the femoral component, 50 ml will be inserted in the gluteus muscles and the proximal part of the iliotibial tract. The last 50 ml will be inserted in the subcutaneous layer.
16073240|NCT02359136|Procedure|Multimodal analgesic regimen|All patients will be operated under spinal anaesthesia with 2.0-3.0 ml Bupivacaine 0.5 % plain, preferably at the L2/L3 alternatively the L3/L4 vertebral interspace. Propofol infusion will be administrated for sedation if needed. Postoperative morphine will be given as needed intravenously when needed. After transfer to a specialized hip arthroplasty unit with a well-defined and experienced program for multimodal rehabilitation, multimodal oral opioid-sparing analgesia will be given to all patients; NSAIDS and Acetaminophen will be given at regular intervals and Oxycodone as needed.
16073241|NCT02359123|Other|Cannabics capsules|Cannabis extract in an oil formulation
16073242|NCT02359110|Drug|Gabapentin|Patients will receive Gabapentin 300mg tab less than 1 hour before surgery.
16073243|NCT02359110|Other|Placebo|Patient will receive placebo tab less than 1 hour before surgery
16073244|NCT02359097|Procedure|Dynamic Susceptibility Contrast-Enhanced Magnetic Resonance Imaging|Undergo MRI including DSC or DCE-CBV mapping
16073245|NCT02359097|Drug|Ferumoxytol|Given IV
16073246|NCT02359097|Drug|Gadoteridol|Given IV
16073247|NCT02359097|Procedure|Magnetic Resonance Imaging|Undergo MRI including SS-CBV
16073248|NCT02359084|Behavioral|Family Navigation|
16073249|NCT02359084|Behavioral|Conventional Care Management|
16073250|NCT02359071|Other|handover duration, handover rate|To better analyze independent variables, we dichotomized the data. First, we dichotomized handover duration into two groups according to the median handoff time of 20 minutes. Second, we divided handover rates into two groups using the median rate of handovers per shift, which was 3.87%.
16073251|NCT02359058|Drug|Ramucirumab|Administered IV
16073252|NCT02359058|Drug|Capecitabine|Administered orally
16073253|NCT02359058|Drug|Cisplatin|Administered IV
16073254|NCT02359058|Drug|S-1|Administered orally
16073255|NCT02359058|Drug|Oxaliplatin|Administered IV
16073256|NCT02359045|Drug|D1400147|Treatment A
16073257|NCT02359045|Drug|D14000136|Treatment B
16073258|NCT02359045|Drug|D14000137|Treatment C
16073259|NCT02359045|Drug|Epanova®|Treatment D
16073260|NCT02359032|Drug|ASP6858|Oral tablets
16073261|NCT02359032|Drug|Placebo|Oral tablets
16073262|NCT02359019|Biological|Pembrolizumab|Given IV
16073263|NCT02359019|Other|Laboratory Biomarker Analysis|Correlative studies
16073264|NCT02359006|Drug|Minocycline|Minocycline will be compared with placebo
16073265|NCT02359006|Drug|Placebo|Placebo will be compared with minocycline
16073266|NCT02358993|Drug|methenamine hippurate|A urinary antiseptic used for prevention of UTI
16073267|NCT02358993|Drug|Ciprofloxacin|An antibiotic used for treatment and prevention of UTI
16073268|NCT02358980|Device|KIDNEY therapy|
16073269|NCT02358967|Dietary Supplement|TRF (Tocotrienol-rich-fraction)|2 x 150 mg capsules
16073270|NCT02358967|Dietary Supplement|Placebo|2 x 150 mg capsules
16073271|NCT02358954|Procedure|Quantitative sensory testing|Measurement of warm and cold detection and pain thresholds
16073272|NCT02358954|Procedure|CHEPS|Measurement of amplitude and latency of cortically evoked potentials
16073273|NCT02358954|Procedure|3D Turntable|
16073274|NCT02358954|Procedure|Vection stimulation|
16073275|NCT02358941|Behavioral|Neurofeedback training|In neurofeedback training, EEG-activity is visualized and fed back to the participant online on a computer screen. Successful regulation is rewarded by bonus points. The aim is to gain control over one's brain activity and to be able to switch to or to maintain a more wakeful, alert or focussed state.
16073276|NCT02358941|Behavioral|Computerized cognitive training|In computerized cognitive training, impaired neuropsychological functions, such as inhibition, working memory, distractibility, are directly trained by adaptive computerized software programs. We use training programs from a scientifically based training system for patients presenting problems with sustained, focussed or selective attention, working memory, inhibition, processing speed. Good performance / improvements are rewarded with bonus points.
16073280|NCT02358902|Procedure|active intervention of aerobic exercise|different types of aerobic exercise
16073281|NCT02358902|Device|placebo tDCS|only 30 seconds of cortical stimulaion , with the power turned off for the remaining time (tDCS - DC stimulator, Neurocom, Germany)
16073282|NCT02358902|Procedure|placebo AE|the procedure was a training on the treadmill, but heart rate was maintained within 5% of the resting heart rate at the minimum speed on the treadmill
16073283|NCT02358889|Biological|hI-con1|Intravitreal injection of hI-con1 0.3 mg
16073284|NCT02358889|Biological|ranibizumab|Intravitreal injection of ranibizumab 0.5 mg
16073285|NCT02358889|Other|Sham injection|No injection is given, a needleless syringe is used to mimic an injection.
16073286|NCT02358863|Drug|Modified FOLFOX6|Oxaliplatin 85 mg/m2 IV Day 1 every 14 days Leucovorin 400 mg/m2 IV over 2 hours Day 1 5-FU 400 mg/m2 IV over 2 hours Day 1 5-FU 2400 mg/m2 IV over 46 hours Day 1
16073287|NCT02358863|Drug|Docetaxel/Capecitabine|Docetaxel 30 mg/m2 IV Days 1 and 8 Capecitabine 825 mg/m2 PO BID Days 1-14
16073288|NCT02358863|Drug|Cisplatin/Irinotecan|Cisplatin 30 mg/m2 IV Days 1 and 8 every 21 days Irinotecan 65 mg/m2 IV days 1 and 8 every 21 days
16073289|NCT02358863|Drug|Cisplatin/Docetaxel|Cisplatin 75 mg/m2 IV Day 1 every 21 days Docetaxel 75 mg/m2 IV Day 1
16073290|NCT02358863|Drug|IRI/EPI|Irinotecan IV over 90 minutes Days 1 and 8 every 28 days Epirubicin IV over 10-15 minutes Days 1 and 8 every 28 days
16073291|NCT02358863|Drug|EPI/Docetaxel|Docetaxel 75 mg/m2 Day 1 every 21 days Epirubicin 50 mg/m2 IV Day 2
16073292|NCT02358863|Drug|Irinotecan/Docetaxel|Irinotecan 120 mg/m2 Day 1 every 21 days Docetaxel 50 mg/m2 IV Day 1
16073293|NCT02358863|Drug|Docetaxel|Docetaxel 60-100 mg/m2 IV day 1 every 21 days
16073294|NCT02358850|Drug|Norco (Hydrocodone and Acetaminophen)|Norco (Hydrocodone and Acetaminophen) 5/325 mg tab Take 1-2 tabs by mouth every 4-6 hours PRN (as needed) pain following Tonsillectomy for 14 days
16073295|NCT02358850|Drug|Percocet (Oxycodone and Acetaminophen)|Percocet (Oxycodone and Acetaminophen) 5/325 mg tab Take 1-2 tabs by mouth every 4-6 hours PRN pain following Tonsillectomy for 14 days
16073296|NCT02358850|Drug|Dilaudid (hydromorphone)|Dilaudid (hydromorphone) 2 mg tab Take 1-2 tabs by mouth every 4-6 hours PRN pain following Tonsillectomy for 14 days
16073297|NCT02358850|Drug|Tylenol (Acetaminophen)|Tylenol (Acetaminophen) 325 mg tab Take 1-2 tabs by mouth every 4-6 hours PRN pain following Tonsillectomy for 14 days
16073298|NCT02358824|Drug|CKD-828|"Telmisartan 80mg /S-Amlodipine 5mg(FDC) Tablet, Oral, Once Daily
~(1arm:2period and 4period, 2arm:1period and 3period)"
16073299|NCT02358824|Drug|Telmisartan|"- Telmisartan 80mg tablet, Oral, Once Daily (Combination Therapy with S-amlodipine)
~(1arm:1period and 3period, 2arm: 2period and 4period)"
16073300|NCT02358824|Drug|S-amlodipine|"- S-amlodipine 5mg tablet, Oral, Once Daily (combination Therapy with Telmisartan)
~(1arm:1period and 3period, 2arm: 2period and 4period)"
16073301|NCT02358811|Device|Magnetic resonance imaging (MRI)|"The acquisition of the image will last 45 minutes with 6 sequences.
~Before any examination, the manipulator will check the absence of contraindication to MRI.
~During the fifth sequence, Gadolinium (Gadovist®) will be injected intravenously to the concentration 0.1 mmol / kg. For this, a venous catheter will be placed before the first sequence and then removed after the examination. This injection will be carried out according to the usual practice of MRI.
~Throughout the examination, a physician will always be present."
16073302|NCT02358811|Behavioral|Cognitive assessment|"This cognitive assessment will include the following executive tests :
~test of Stroop
~left Trail Making Test A and B
~verbal fluence test
~test of memory of figures direct and inverse in order
~completion of matrices
~Paced Auditory Serial Addition Test (PASAT)"
16073303|NCT02358798|Other|3 years-assessment of respiratory function|
16073304|NCT02358785|Device|ECHELON FLEX™ Powered Plus Stapler|ECHELON FLEX™ Powered Plus Stapler using ENDOPATH ECHELON™ Reloads with Gripping Surface Technology (GST). The combination of stapler plus reload is referred to as the ECHELON FLEX™ GST System.
16073305|NCT02358772|Other|thrombolysis in a pre-hospital setting (STEMO concept)|
16073306|NCT02358759|Procedure|Correction of abnormally fertilized oocytes|Removing of extra developed nucleus from fertilized oocyte.
16073307|NCT02358746|Other|combined endo/epicardial approach|
16073308|NCT02358746|Other|stepwise approach|endocardial scar homogenization only at the first VT ablation procedure
16073309|NCT02358733|Procedure|Intra-cytoplasmic Sperm Injection|Selection of sperm at 400x for sperm injection
16073310|NCT02358733|Procedure|Intra-cytoplasmic Morphologically-selected Sperm Injection|Selection of sperm at 6000x for sperm injection
16073311|NCT02358720|Radiation|Arm A|1x24Gy high dose IMRT on spinal bone metastasis
16073312|NCT02358720|Radiation|Arm B|fractionated conformal RT 10 x 3 Gy on spinal bone metastasis
16073313|NCT02358707|Other|Ibuprofen phonophoresis|
16073314|NCT02358694|Dietary Supplement|Serum-Derived Bovine Immunoglobulin|Patients who weigh less than 40 Kg will receive Serum Derived Bovine Immunoglobulin -5 g daily (2.5 g PO BID) and patients who weigh 40 Kg or more will receive Serum Derived Bovine Immunoglobulin- 10 g daily (5 g PO BID)
16073315|NCT02358694|Other|Placebo|"Matching placebo packets will be supplied and will appear identical to SBI with respect to volume, appearance and taste.
~Patients who weigh less than 40 Kg will take one-half packet BID (2.5 g BID) Patients who weigh 40 Kg or more will take one packet BID (5 g PO BID)."
16073316|NCT02358681|Drug|Ketorolac, intranasal|Ketorolac 1 mg/kg, maximum dose 30 mg. To be administered by intranasal route.
16073317|NCT02358681|Drug|Ketorolac, intravenous|Ketorolac 0.5 mg/kg, maximum dose 30 mg. To be administered by intravenous route.
16073318|NCT02358681|Drug|Placebo, intravenous|Placebo of equal volume to IV ketorolac, to be administered by intravenous route.
16073319|NCT02358681|Drug|Placebo, intranasal|Placebo of equal volume to IN ketorolac, to be administered by intranasal route.
16073320|NCT02358668|Drug|BTI320|BTI320, also known as SUGARDOWN®, is derived from galactomanan which blocks key enzymes that break down carbohydrate in the gut. BTI320 therefore helps to slow down the absorption of carbohydrates to lower post-meal blood sugar.
16073321|NCT02358668|Drug|BTI320 matching placebo|Placebo
16073322|NCT02358655|Other|Retrospective review of OAC prescription|
16073323|NCT02358655|Other|Prescription of OAC in ED|
16073324|NCT02358655|Other|Community AF clinic|
16073325|NCT02358642|Drug|Angiotensin converting enzyme inhibitor (Lisinopril)|
16073327|NCT02358629|Device|NovaCross™ microcatheter|successful delivery, crossing, and retrieval of the investigational device as identified by confirmation of guidewire placement in the distal true lumen confirmed by angiography
16073328|NCT02358603|Diagnostic Test|Chronotropic Incompetence Diagnostic Algorithm|
16073329|NCT02358590|Behavioral|HAPA menu-based mini-video|The intervention will be a multi-target menu-based mini-videos designed to deliver information about vitamin D adherence and its effect on osteoporosis
16073330|NCT02358590|Behavioral|Standard care|The treating physician will advice participants to take vitamin D
16073331|NCT02358577|Device|In-bed cycling|In-bed cycling will be applied using a cycle ergometer (RT300 Supine Cycle Ergometer) for 30 minutes per day in addition to Usual Care, until the physiotherapist deems that the patient is mobilizing well, or a maximum of 7 days (whichever comes first). This cycle ergometer is specifically designed for pediatric use, and can be applied to facilitate lower or upper limb cycling. The intervention will be applied by a trained physiotherapist and/or clinician. Pre-defined Safety Criteria for interrupting or aborting the intervention will be observed. Qualitative interviews will be conducted with a health care provider, the patient where possible, and a family caregiver following the intervention period.
16073332|NCT02358577|Other|Usual Care|Usual care physiotherapy will be applied to patients in the control arm, according to the unit specific guidelines for early mobilization. Qualitative interviews will be conducted with a health care provider, the patient where possible, and a family caregiver following the intervention period.
16073333|NCT02358564|Procedure|Gastrointestinal Permeability Test|This test will involve ingesting a solution followed by urinalysis
16073334|NCT02358564|Procedure|Upper Endoscopy|
16073335|NCT02358564|Procedure|Rectal Barostat and Infusion of Fats|Feeding tube will be placed, as well as a small balloon in the rectum.
16073336|NCT02358551|Device|Placement of electrode lead through axillary vein puncture|
16073337|NCT02358551|Device|Placement of electrode lead through subclavian vein puncture|
16073338|NCT02358538|Drug|Ganaxolone|oral suspension or capsules
16073339|NCT02358525|Behavioral|multi-modality rehabilitation program for heart failure|rehabilitation consists of supervised exercise training, both endurance and strength, as well as gymnastics, diet and psychosocial education around living with heart failure
16073340|NCT02358512|Other|Enteral feeding|Bolus feeds or continuous feeds during a 10-day ICU stay
16073341|NCT02358499|Drug|Posaconazole|Posaconazole will be given as a one time intravenous (IV) dose. The dose will take ninety (90) minutes to be infused and will be based on weight at the time of the visit.
16073342|NCT02358486|Device|Acupuncture|"Acupuncture rationale 1a) Style of acupuncture: body acupuncture (in accordance with meridian theory)
~Needling details 2a) Number of needle insertions per subject per session: 13 2b) Acupoints: Basic points - Large Intestine(LI)4, Stomach(ST)36, Liver(LR)3, Pericardium(PC)3, Spleen(SP)4, Stomach(ST)34, Conception Vessel(CV)12, 2c) Depth: 5 ~ 30mm 2d) Response sought: 'De qi' sensation; 2e) Needle stimulation: Manipulation 2f) Retention time: 15 minutes 2g) Needle type: 0.2 X 40 mm, sterilized stainless steel needle, Dongbang Inc., Korea"
16073343|NCT02358486|Device|Sham acupuncture|The participants in sham acupuncture group are given sham acupuncture treatment at the same acupoints in the same times and method as acupuncture arm. The sham device would be a Streitberger device.
16073344|NCT02358473|Biological|mogamulizumab|Mogamulizumab will be administered by IV infusion.
16073345|NCT02358473|Drug|Docetaxel|Docetaxel will be administered by IV infusion.
16073346|NCT02358460|Device|Ventilation delivered by SLE5000 ventilator|"In pressure-limited ventilation arm, ventilator settings as required to maintain appropriate oxygenation and carbon-dioxide elimination.
~In volume-targeted ventilation arm, set target volume at 5ml/kg and wean rate. In both arms, aim to keep blood gases within normal limits."
16073347|NCT02358447|Procedure|TKR|non-navigated versus computer-navigated total knee replacement
16073348|NCT02358434|Radiation|Observational use of fluoroscopy|
16073349|NCT02358408|Device|Blood glucose monitoring systems for self-testing|
16073350|NCT02358395|Drug|BBI608|Administered continuously twice daily with doses separated by 9-15 hours.
16073351|NCT02358395|Drug|Sorafenib|Sorafenib 400 mg twice daily (800 mg total daily dose).
16073352|NCT02358382|Drug|pH Stat|pH stat blood gas management - increased carbon dioxide content of administered gas mixture.
16073353|NCT02358369|Drug|Bimatoprost|Bimatoprost sustained release Ocular Insert
16073354|NCT02358369|Drug|Timolol 0.5%|BID drops OU, 0.5% ophthalmic solution
16073355|NCT02358369|Device|Placebo Ocular Insert|Placebo ocular insert OU.
16073356|NCT02358369|Drug|Placebo Eye Drops|Placebo eye drops BID OU.
16073357|NCT02358356|Drug|octreotate|7.8GBq 177Lu Octreotate (Lutate) given intravenously (IV)
16073358|NCT02358356|Drug|Capecitabine|oral capecitabine 750mg/m2 b.i.d.
16073359|NCT02358356|Drug|Temozolomide|temozolomide 75mg/m2 b.i.d.
16073360|NCT02358343|Behavioral|Engagement Interview|An Engagement Interview will comprise a one-on-one session with the patient, during which the health-care provider will use reflective statements and non-judgmental listening techniques, will explore barriers to treatment, and will help patient articulate ambivalence about engaging in treatment. This session will be enhanced with a 40-minute DVD that the subject will watch with the therapist in the dialysis facility. The subject will be encouraged to take the DVD home with them and watch it with their family members as well.
16073361|NCT02358343|Behavioral|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) is a short-term psychotherapy that will focus on how the individual is thinking, behaving, and communicating today rather than on their childhood experience. The therapist will assist the patient in identifying specific distortions (cognitive assessment) and biases in thinking and will provide guidance on how to change this thinking. During the course of intervention, study subjects will undergo assessment of severity of depressive symptoms using Quick Inventory of Depressive Symptoms - Self-Report (QIDS-SR) every two weeks for the first six weeks (weeks 0, 2, 4, and 6) and every three weeks for the next six weeks (weeks 9 and 12).
16073430|NCT02357823|Other|Evaluation of immunological response|Study of short and long term immunological response after different schedule of PCV13 or PPV23
16073431|NCT02357823|Other|Nasopharyngeal swabs analysis|Evaluation of pneumococcal nasopharyngeal colonization
16073432|NCT02357810|Drug|Pazopanib Hydrochloride|Given PO
16073433|NCT02357810|Drug|Oral Topotecan Hydrochloride|Given PO
16073362|NCT02358343|Drug|Antidepressant Drug Therapy|The site investigators will prescribe sertraline drug at a starting dose of 25 mg oral tablets. Dose titration will be implemented using standardized assessments of depressive symptoms and drug side effects; and the research team and the patient make joint decisions to maintain, increase, or decrease the dose. This will help establish the highest effective but tolerable dose tailored for each patient. The QIDS-SR scale will be used to assess the clinical response for dose titration. The FIBSER scale will be used to assess side effects and the degree to which they interfere with day-to-day functions. The participant-specific dose at week 6, up to a maximum of 200 mg/d, will be continued for the remaining 6 weeks.
16073363|NCT02358330|Other|EHR Enhanced Clinic Intervention|The clinics assigned to the experimental condition will have EHR enhancements introduced.
16073364|NCT02358317|Behavioral|Video Game Motor Training|
16073365|NCT02358317|Behavioral|Sedentary Video Game Training|
16073366|NCT02358304|Drug|nasal spray calcitonin|recurrence rate of aggressive CGCG will be recorded after the use of nasal spray calcitonin
16073367|NCT02358304|Drug|Placebo|
16073368|NCT02358291|Procedure|open discectomy|The open discectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision.
16073369|NCT02358291|Procedure|microendoscopic discectomy|Microendoscopic discectomy combines standard lumbar microsurgical techniques with endoscope, enabling surgeons to successfully address free-fragment disc pathologic factors and lateral recess stenosis.
16073370|NCT02358291|Procedure|transforaminal endoscopic lumbar discectomy|transforaminal endoscopic lumbar discectomy removes the intervertebral disc portion through the intervertebral foramen
16073371|NCT02358265|Drug|10 mg Rupatadine on demand|Group A1 (dose administered: 10 mg rupatadine on demand): one tablet of placebo once daily- one on-demand tablet of rupatadine 10 mg intake only if needed.
16073372|NCT02358265|Drug|10 mg Rupatadine|Group B1 (dose administered: 10 mg rupatadine continuously): one tablet of rupatadine 10 mg once daily, one on-demand tablet of placebo, intake only if needed.
16073373|NCT02358265|Drug|20 mg Rupatadine|Group B2 (dose administered: 10 mg rupatadine continuously): two tablets of rupatadine 10 mg daily- one on-demand tablet of placebo , intake only if needed.
16073374|NCT02358265|Drug|10 mg Rupatadine on demand (sham updosing to 20 mg)|Group A2 (dose administered: 10 mg rupatadine on demand): two tablets of placebo daily- one on-demand tablet of rupatadine 10 mg ,intake only if needed.
16073375|NCT02358239|Procedure|acupuncture|Experiment group received acupuncture at Zusanli (ST36) and Neiguan (PC6) acupuncture points
16073376|NCT02358226|Behavioral|Soccer League (SL)|Participants will be invited to attend soccer practice in the late afternoons, roughly 2-3 times per week. Competitive games will be held on Saturdays so that friends and family may attend. Using a mobile phone application, coaches will regularly record information on participants' arrival and departure times, sportsmanship, volunteering in the community, the results of saliva tests for drugs and alcohol. The SL intervention arm will last for one year.
16073377|NCT02358226|Behavioral|Soccer League/Vocational Training (SL-V)|In addition to the SL intervention, participants will gain access to vocational training. The Vocational Training will take place through the Silulo or Zenzele programs based in Khayelitsha for a period of 6 months. These programs offer practical and market-related training in computer skills, woodwork, or welding. The SL-V intervention arm will last for one year; with six months dedicated to soccer and six months dedicated to vocational training.
16073378|NCT02358213|Procedure|Ultrasound|Ultrasound examinations are done 5 times
16073379|NCT02358200|Drug|BMN-673|
16073380|NCT02358200|Drug|Carboplatin|
16073381|NCT02358200|Drug|Paclitaxel|
16073382|NCT02358187|Biological|Experimental: HLA-A2 Restricted Glioma Antigen-Peptides with Poly-ICLC|Poly-ICLC is administered intramuscularly (i.m.) using sterile technique, as supplied from the vial, and in the amount prescribed for the participant's weight. Patients should receive a dose of acetaminophen (15 mg/kg up to a max of 1000 mg) 30-60 minutes before each poly-ICLC administration. The poly-ICLC treatments will be administered immediately following the vaccine. Patients/parents will be asked to report any temperature elevations and side effects after each treatment.
16073383|NCT02358174|Procedure|Hemorrhoidectomy|"Grade III and IV patients were treated with surgery according to Milligan-Morgan (Milligan-Morgan laser optical fibers variant) procedure.
~All patients will perform blood sampling for MMPs and NGAL plasma levels evaluation"
16073384|NCT02358174|Other|blood sampling|blood sampling for MMPs and NGAL plasma levels evaluation (ELISA test)
16073385|NCT02358174|Other|tissue sampling|tissue sampling for MMPs and NGAL tissue levels evaluation (Western Blot)
16073386|NCT02358161|Drug|gemcitabine and nab paclitaxel|DLT adn MTD of LED225 co-administered with fixed doses of gemcitabine and nab-paclitaxel in patients with advanced or metastasized pancreatic cancer
16073387|NCT02358135|Other|Collaborative Connected health, (CCH)|CCH is an asynchronous, secure online platform where patients can upload images of psoriasis lesions and submit assessments. Likewise, practitioners can request and/or initiate dermatology consultations, assume longitudinal care or communicate with patients directly.
16073388|NCT02358135|Other|Control|In-person care is the control group because it is currently considered the standard of care in delivering dermatologic services. The intervention includes regular visits to a physician, and may include such treatments as ointments, steroids or UV therapy at the discretion of a physician. In-person care is the major healthcare-delivery model for managing chronic skin diseases and a realistic, primary option that patients face. The patients in the in-person arm can seek psoriasis care from PCPs or dermatologists, just as they would in the real world.
16073389|NCT02358122|Other|Wholegrain rye|A variety of cereal foods providing >100g/day wholegrain from rye
16073390|NCT02358122|Other|Wholegrain wheat|A variety of cereal foods providing >100g/day wholegrain from wheat
16073391|NCT02358122|Other|Refined wheat|A variety of cereal foods providing 0g/day wholegrain
16073434|NCT02357810|Other|Laboratory Biomarker Analysis|Correlative studies
16073435|NCT02357797|Drug|Vortioxetine|
16073436|NCT02357797|Other|Placebo|
16073487|NCT02357342|Drug|Standard of Care intravitreal injections of anti-VEGF|intravitreal injections of anti-VEGF
16073392|NCT02358109|Behavioral|exercise|The exercise intervention will be performed in groups of 20 participants which will train 3 days/week (60 min per session) for a 16-week period. Sessions will be designed and carefully supervised by exercise monitors, including a 15 minute warm-up period followed by 35 minute focused on aerobic exercises, developed progressively at intensity sufficient to achieve 50% (at the beginning of the intervention) and 80% (the last month of the intervention) of predicted maximum heart rate (209-0.73 × age) and resistance strength training.Monday sessions will involve resistance strength exercises. Wednesday sessions will include balance oriented activities and dancing aerobic exercises. Fridays will include aerobic, resistance strength and coordination using a circuit of different exercises.Sessions finish with a 10 minute cool-down period of stretching and relaxation exercises.
16073393|NCT02358096|Drug|ASP8232|oral capsule
16073394|NCT02358096|Drug|Placebo|oral capsule
16073395|NCT02358083|Behavioral|Provider Communication about Vaccination|There are 12 pairs of messages varying in target vaccination, discussion of relative safety of vaccination, and strength of provider recommendation for vaccination.
16073396|NCT02358057|Drug|Dexmedetomidine|
16073397|NCT02358057|Drug|Alfentanil|
16073398|NCT02358044|Drug|Sofosbuvir|400 mg tablets, taken orally (PO) every day (QD) for 12 weeks.
16073399|NCT02358044|Biological|PegIntron|PegIntron administered subcutaneously every week (QW) at 1.5 mcg/kg for 12 weeks.
16073400|NCT02358044|Drug|Ribavirin|Capsule and/or tablet administered PO twice daily (BID) based on weight (1000 - 1200 mg) for 12 weeks.
16073401|NCT02358044|Drug|Grazoprevir/Elbasvir (100 mg/50 mg) FDC|Grazoprevir/Elbasvir (100 mg/50 mg) FDC, taken PO QD for 12 weeks.
16073402|NCT02358031|Biological|Pembrolizumab|Pembrolizumab 200 mg IV on Day 1 of each 3-week cycle for up to 24 months.
16073403|NCT02358031|Drug|Cisplatin|Cisplatin 100 mg/m^2 IV on Day 1 of each 3-week cycle (6 cycle maximum).
16073404|NCT02358031|Drug|Carboplatin|Carboplatin at a target AUC 5 IV on Day 1 of each 3-week cycle (6 cycle maximum).
16073405|NCT02358031|Drug|5-FU|5-FU 1000 mg/m^2/day IV continuous from Day 1-4 of each 3-week cycle (6 cycle maximum).
16073406|NCT02358031|Biological|Cetuximab|Cetuximab on Day 1 at a dose of 400 mg/m^2 IV, and then 250 mg/m^2 IV on Day 1 of each subsequent week until disease progression or unacceptable toxicity
16073407|NCT02358018|Drug|68Ga-DOTATOC PET/CT Scan|Study participants will undergo the 68Ga-DOTATOC PET/CT after informed consent. The nominal injected dose will be up 3-5.5 mCi containing approximately 10 - 50 microgram of 68Ga-DOTATOC and will be injected via IV access lines. CT scans will be performed with our standard oral contrast agent (typically Omnipaque and/or barium) in accordance with our standard FDG practice unless some contraindication is present. Uptake period following injection will be 0.75-1hour. Acquisition time will be approximately ~1 hour. In patients who may not be able to lie still, anesthesia will be provided as per routine standard clinical practice.
16073408|NCT02358005|Procedure|Extracorporeal shock wave therapy 60mj|
16073409|NCT02358005|Procedure|Extracorporeal shock wave therapy 120mj|
16073410|NCT02358005|Procedure|non extracorporeal shock wave therapy|
16073411|NCT02357992|Radiation|Stereotactic Body Radiotherapy (SABR)|SABR once a day for 3-4 days in a row, 50Gy in 4 fractions for central tumor, or 54Gy in 3 fractions for peripheral tumor.
16073412|NCT02357979|Device|Laser|CO2 - 9.3μm short-pulsed laser irradiation will occur on the occlusal enamel surface. This results in changes in crystal composition and structure, which increase the resistance of dental mineral to dissolution by acid and will work to better prevent dental caries in the occlusal surface of vital teeth when compared to fluoride therapy alone over 12 months.
16073413|NCT02357979|Other|Fluoride|The Fluoride varnish is painted on the occlusal surface of the tooth. Fluoride varnish makes enamel more acid resistant.
16073414|NCT02357966|Biological|514G3|True Human Monoclonal Antibody
16073415|NCT02357966|Drug|Placebo|Buffered saline solution
16073416|NCT02357966|Drug|Standard IV antibiotic therapy|standard antibiotic therapy will be determined by the attending physician and will be guided by the results of cultures with sensitivities.
16073417|NCT02357953|Other|Measurement of cardiac index|
16073418|NCT02357940|Drug|Experimental Product|1% Colloidal Oatmeal Balm
16073419|NCT02357927|Behavioral|Mini-AFTERc|20-30 minute structured conversation following guidelines and instruction within the Mini-AFTERc 20 page manual
16073420|NCT02357927|Behavioral|telephone call|this consists of a 20-30 minute conversation about the general well-being of the patient with no specific reference to recurrence fears unless raised by the patient explicitly themselves
16073421|NCT02357901|Drug|SUBOXONE|SUBOXONE (buprenorphine sublingual film) is used for induction therapy. Participants take sublingual film for 3 days according to the sublingual film prescribing information; they then complete a 4-to-11 day sublingual film dose adjustment at doses ranging from 8 mg to 24 mg sublingual film prior to randomization. Following randomization, SUBOXONE use is tapered from 6 mg to 2 mg from Days 1-5 and then discontinued.
16073422|NCT02357901|Drug|RBP-6000|Six injections administered subcutaneously every 28 days on alternate sides of participant's abdomen at either 300 mg or 100 mg dose.
16073423|NCT02357901|Drug|Placebo|Six injections of placebo administered subcutaneously every 28 days on alternate sides of participant's abdomen at volumes matching the experimental drug.
16073424|NCT02357888|Drug|V0018|Oromucosal - Single dose
16073425|NCT02357888|Drug|Placebo|Oromucosal - Single dose
16073426|NCT02357862|Procedure|Mitral Valve Annuloplasty|Mitral valve annuloplasty by a rigid mitral ring, a semi-rigid ring, or a fully flexible band, at the surgeon's discretion
16073427|NCT02357849|Drug|Aripiprazole|see arm description
16073428|NCT02357849|Drug|Fluoxetine|see arm description
16073429|NCT02357836|Drug|Itraconazole|"Once on study, itraconazole will be taken twice daily for a total of 10-14 days. After being on itraconazole for 7-10 days, Post-treatment assessments will include a skin biopsy, blood draw for the PK (pharmacokinetics) analyses and the cytokine panel, and also MRI evaluations (anticipated to last 45-50 minutes). Toxicity assessments and laboratory checks will also be conducted during that time. Following these assessments, itraconazole will be continued until the day of surgery. At the time of surgical resection, a tissue sample (with adjacent normal tissue as per standard resection technique) will be obtained to complete the analysis. Following resection, subjects will be followed per standard post-operative procedure."
16073563|NCT02356705|Drug|Midazolam|midazolam 0.2 mg/kg given intranasally
16073437|NCT02357784|Device|Neurometer|The purpose of Current Perception Threshold (CPT) testing is to help physicians better understand how Sacral Neuromodulation affects the nerves of patients with dual incontinence. CPT Testing involves the use of a portable battery-operated machine which will stimulate the subject's nerves via an electrical stimulation. Electrodes will be placed via a catheter in to the subject's urethra and rectum, and the electrical current will be increased gradually until the subject feels the onset of tingling, buzzing, or warmth at the site of the electrode. The electrical current will then gradually decrease until no sensation of stimulation is felt. The procedure will then be repeated where the subject will be asked to hold the test button to increase the stimulus intensity above their sensory threshold (above the point where they can feel it) until the device automatically shuts off.
16073438|NCT02357771|Drug|Probiotic (L. brevis CD2 lozenges)|Each Lactobacillus brevis CD2 lozenge contains not less than 1 billion Colony Forming Unit of L. brevis CD2
16073439|NCT02357771|Drug|Placebo|Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)
16073440|NCT02357758|Drug|Antibiotic Prophylaxis|Approved clinical dosage or antibiotics
16073441|NCT02357745|Procedure|Non surgical periodontal therapy|scaling and root planing
16073442|NCT02357732|Drug|Nivolumab|
16073443|NCT02357732|Drug|Trametinib|
16073444|NCT02357732|Drug|Dabrafenib|
16073445|NCT02357719|Device|VistaO2 FLUX device|Full night VistaO2 FLUX device monitoring synchronized with the gold standard polysomnography.
16073446|NCT02357706|Device|APAP A (ResMed AirSense AutoSet)|Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events
16073447|NCT02357706|Device|APAP B (Apex iCH Auto)|Commercially available device used to treat obstructive sleep apnea. The device automatically senses breathing and adjusts delivered pressure based on obstructive events
16073448|NCT02357693|Drug|Aprepitant|Aprepitant or placebo will be administered to the patient before surgery
16073449|NCT02357680|Other|Diary|"The intervention is a notebook in which the relative will be asked to keep a diary of the time when the patient is critically ill in the ICU. At least two photos of the patient will be added to the diary upon full consent from the patient.
~The diary contains a written description on how to use the diary during and after the patients stay in the ICU."
16073450|NCT02357654|Drug|GnRH|single shot of GnRH agonist
16073451|NCT02357654|Drug|placebo|placebo
16073452|NCT02357641|Other|retrospective echographic myocardial strain analysis refering to acute coronary syndrome|retrospective evaluation for cut off value of circumferential and radial echographic strain parameters corresponding to acute coronary disease
16073453|NCT02357628|Device|Wound treatment with RO-NPT|
16073454|NCT02357628|Device|Wound Irrigation|
16073455|NCT02357615|Drug|nifedipine CR tablets (Xin Ran)|
16073456|NCT02357615|Drug|Adalat|
16073457|NCT02357602|Drug|GS-7340|Medication is supplied in 10 or 25mg tablets, so subjects will receive either 1/2 or one tablet in a single dose.
16073458|NCT02357589|Procedure|2D laparoscopic cholecystectomy|
16073459|NCT02357589|Procedure|3D laparoscopic cholecystectomy|
16073460|NCT02357576|Drug|Intralipid 20% I.V. Fat Emulsion|
16073461|NCT02357563|Drug|ulipristal acetate|5 mg/day will be administered starting from day 1 of the cycle and up to three months later for two courses, with an interval between the courses of 1 month
16073462|NCT02357563|Drug|Leuprolide acetate|One dose of 11.25 GnRH analogue depot will be administered in the luteal phase of the menstrual cycle (days 21-24) and repeated 3 months later
16073463|NCT02357550|Drug|ketone|3-OHB is infused intravenously.
16073464|NCT02357550|Drug|placebo|Saline infusion.
16073465|NCT02357537|Behavioral|Combined Anti-inflammatory Diet (CAID)|The CAID requires participants to modify their diet to include certain types of foods that may have anti-inflammatory properties. Participants on the CAID will be required to abstain from red meat and alcoholic beverages.
16073466|NCT02357524|Drug|Oritavancin|
16073467|NCT02357511|Device|Study Monitor used|
16073468|NCT02357498|Procedure|transsphenoidal surgery|
16073469|NCT02357485|Biological|ADSC|Single injection of ADSC
16073470|NCT02357472|Drug|dehydroepiandrosterone|high dose group treatment represent for 50mg t.i.d and standard dose group represents for normal treatment with 25mg t.i.d. Each patients in these two group will take one capsule each time and three times a day for three months before entering into IVF cycles.
16073471|NCT02357459|Drug|FX006|Single 5 mL IA injection
16073472|NCT02357459|Drug|Placebo|Single 5 mL IA injection
16073473|NCT02357459|Drug|TCA IR 40|Single 1 mL IA injection
16073474|NCT02357433|Device|High Doses CPFA|
16073475|NCT02357420|Drug|Relamorelin|Double blind relamorelin was given subcutaneously BID for 12 weeks.
16073476|NCT02357420|Drug|Placebo|Placebo given subcutaneously for 12 weeks.
16073477|NCT02357407|Drug|Patients in intensive care : infection treated with ciprofloxacin IV|8-10 samples per patients on day-4 of their treatment
16073478|NCT02357407|Drug|Osteoarticular infected patients : infection treated with oral ofloxacin|8-10 samples per patients on day-4 of their treatment
16073479|NCT02357394|Device|Arabin Pessary|Arabin pessary is a ring manufactured from medical grade silicone. It comes in 13 different sizes. Participants will be fitted to the appropriate size by the study team.
16073480|NCT02357381|Device|eNeura SpringTMS|Single pulse magnetic stimulation for prevention and/or treatment of migraine headache with or without aura.
16073481|NCT02357368|Drug|Depot medroxyprogesterone acetate (DMPA)|DMPA will be administered every 12 weeks at the standard dose of 150 mg IM, beginning from week 3 of study enrollment and repeated at week 15.
16073482|NCT02357368|Device|Etonogestrel implant (Eng-Implant)|A standard nexplanon rod implant will be placed at study week 3 by a trained clinician.
16073483|NCT02357368|Device|Levonorgestrel intrauterine device (Lng-IUD)|A standard Mirena IUD will be placed at study week 3 by a trained clinician.
16073484|NCT02357368|Device|ParaGard® T 380A Intrauterine Copper Contraceptive|A standard ParaGuard IUD will be placed at study week 3 by a trained clinician.
16073485|NCT02357355|Device|UIHC Driving Simulator|This is a driving simulator located in the basement of the hospital. A car will be facing a large video screen of a driving simulation.
16073486|NCT02357342|Drug|Sirolimus|intravitreal injection
16073488|NCT02357303|Drug|Simethicone|100mL of water plus 100mg Simethicone by mouth, 15 to 30 minutes before endoscopy
16073489|NCT02357303|Drug|Acetylcysteine|100mL of water plus 100mg Simethicone plus 600mg N-acetylcysteine by mouth, 15 to 30 minutes before endoscopy
16073490|NCT02357303|Other|Placebo|100mL of water
16073491|NCT02357290|Drug|Open-label Treatment with N-Acetylcysteine|
16073492|NCT02357277|Drug|Budesonide|inhaled glucocorticoid budesonide as dry powder inhaler
16073493|NCT02357277|Other|Placebo Inhaler|inhaled placebo
16073494|NCT02357264|Device|Ultrasound|Ultrasound of the chest for the detection of fluid in the lung
16073495|NCT02357251|Other|Enhanced recovery protocol|
16073496|NCT02357225|Drug|Pyridostigmine Bromide|Pyridostigmine is an acetylcholinesterase inhibitor, which increases the amount of acetylcholine at the neuromuscular junction. It will be taken orally, either as a tablet or as a syrup.
16073497|NCT02357212|Procedure|coronary angiography|invasive procedure performed to determine coronary anatomy
16073498|NCT02357212|Procedure|adenosine stress test|non-invasive procedure to determine area of cardiac ischemia
16073499|NCT02357199|Other|Intensive oral care & didactic training|Professional (dental hygienist) intensive oral care intervention and individual patient training/didactic instruction to promote patient compliance and patient capability of oral preventive measures in a long-term perspective.
16073500|NCT02357173|Other|electronic cigarette|
16073501|NCT02357173|Other|cigarette group|
16073502|NCT02357160|Behavioral|Artwork|Prints by local artists that are hung on the walls of patient rooms.
16073503|NCT02357147|Drug|Placebo|"Combination Phase - Placebo will be administered IV (intravenous infusion) once weekly for six 21-day cycles.
~Maintenance Phase - Placebo will be administered IV (intravenous infusion) once weekly until disease progression."
16073504|NCT02357147|Drug|Amatuximab|"Combination Phase - Amatuximab 5mg/kg will be administered IV (intravenous infusion) once weekly for six 21-day cycles.
~Maintenance Phase - Amatuximab 5mg/kg will be administered IV (intravenous infusion) once weekly until disease progression."
16073505|NCT02357147|Drug|Pemetrexed|Combination Phase - Pemetrexed 500 mg/m^2 will be administered IV on Day 1 of each 21-day cycle for 6 cycles.
16073506|NCT02357147|Drug|Cisplatin|Combination Phase - Cisplatin 75 mg/m^2 will be administered IV on Day 1 of each 21-day cycle for 6 cycles.
16073507|NCT02357134|Procedure|Oxygen Therapy|Receive high-flow oxygen
16073508|NCT02357134|Procedure|Oxygen Therapy|Receive high-flow air
16073509|NCT02357134|Other|Quality-of-Life Assessment|Ancillary studies
16073510|NCT02357134|Other|Questionnaire Administration|Ancillary studies
16073511|NCT02357134|Procedure|Respiratory Therapy|Receive low-flow oxygen
16073512|NCT02357134|Procedure|Respiratory Therapy|Receive low-flow air
16073513|NCT02357121|Device|Focal Laser Ablation|Focal laser ablation of prostate tissue using laser interstitial thermal therapy (LITT) under MR/ultrasound fusion guidance
16073514|NCT02357108|Other|Video|Watch two short videos with a 4-minute interval between the two of them, estimate 8 minutes to watch both the videos.
16073515|NCT02357108|Behavioral|Survey|One set of surveys before first video and one set after each video played, estimate total of 30 minutes for all surveys.
16073516|NCT02357095|Procedure|monitoring|uterine artery chemo-embolization combined with suction curettage under different monitoring methods,such as hysteroscopic monitoring,ultrasonography monitoring and no monitoring
16073517|NCT02357082|Radiation|MRI Scan|MRI scan with Specific Absorption Rate (SAR) limit of 1.5 watts per kilogram of body weight
16073518|NCT02357069|Drug|Enbrel|Etanercept
16073519|NCT02357069|Drug|LBEC0101|Etanercept
16073520|NCT02357056|Other|Wet Lab|ITA dissection and Annuloplasty Sutures in porcine model.
16073521|NCT02357056|Other|Dry Lab|Camera and clutching, peg transferring, intracorporeal knot tying
16073522|NCT02357056|Other|Virtual Reality|daVinci Surgical Skills simulation
16073523|NCT02357043|Device|Dario Blood Glucose Monitoring System|Finger-stick obtained with BGMS
16073524|NCT02357043|Device|YSI|Finger-stick sample obtained by nurse/technician to be tested with YSI
16073525|NCT02357030|Drug|Methyl-P plus GWI Nutrient Formula|"Week 1:
~One tablet of Methyl-P (5mg) twice daily
~Four tablets of GWI Nutrient Formula twice daily
~Week 2 to Week 12 :
~Two tablets of Methyl-P (10mg) twice daily
~Four tablets of GWI Nutrient Formula twice daily"
16073526|NCT02357017|Dietary Supplement|NaCl tablets|
16073527|NCT02357004|Drug|Carvedilol|CR 40 mg daily in addition to normal BP medications
16073528|NCT02357004|Drug|Chlorthalidone|12.5 mg daily in addition to normal BP medications
16073529|NCT02356991|Drug|Famitinib|
16073530|NCT02356991|Drug|Placebo|
16073531|NCT02356978|Device|Arm1 homemade phototherapy treatment|"session of 10 or 12 hours phototherapy treatment using the homemade device during the first night and then the DRAP device during the next nights."
16073532|NCT02356978|Device|DRAP|
16073533|NCT02356965|Drug|Ketamine|Single dose of sublingual investigational medication administered when subjects develop moderate to severe pain after third molar extraction.
16073534|NCT02356965|Drug|Placebo (for Ketamine)|Sublingual sugar pill developed to mimic ketamine sublingual dose.
16073535|NCT02356952|Behavioral|Mediterranean Diet|A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods).
16073536|NCT02356952|Behavioral|Low Glycemic Index Diet|A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods).
16073537|NCT02356952|Behavioral|Low Glycemic Index Mediterranean Diet|A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods).
16074007|NCT02353299|Drug|Placebo|placebo single nighttime dose-4 hours
16073540|NCT02356913|Drug|Nicotine gum|
16073541|NCT02356900|Procedure|Hyperoxic hyperbaric interval exercise training|Six 30-min high-intensity interval training sessions completed 3-times a week while at 1.4 ATA of oxygen in a hyperbaric chamber.
16073542|NCT02356900|Procedure|Normoxic, normobaric, interval exercise training|Six 30-min high-intensity interval training sessions completed 3-times a week.
16073543|NCT02356900|Drug|Oxygen|Used in Hyperoxic hyperbaric interval exercise training intervention
16073544|NCT02356887|Diagnostic Test|Jugular venous ultrasound|All volunteers will be fully awake throughout the study and be kept comfortable. A cross will be marked where the left and right IJV cross the level of C6. This is where all the measurements will be taken in 3 different conditions at rest, jugular occlusion and valsalva maneuver. At each conditions, the left and right IJV will be scanned with an ultrasound measuring the cross sectional area and Doppler velocity of the IJV. The least amount of pressure will be used to press on the ultrasound probe and the measurements will be obtained at end inspiration. The IJV flow is then calculated.
16073545|NCT02356874|Behavioral|Exercise|An exercise program for 40-60 minutes three times a week in 3 months. Twice a week the exercise sessions will be supervised by a physiotherapist and these sessions will consist of endurance and strength training. The endurance training will be high intensity interval training on a treadmill. And strength training with external load for the major muscle groups (individually adapted: six exercises, eight to ten repetitions maximum, two to three sets). Once a week the participants will exercise individually for a minimum of 40 minutes of endurance exercise.
16073546|NCT02356861|Device|Photomedex Sham Helmet with Red/Near-Infrared Light-Emitting Diodes (LEDs) that are not turned on|"The LED helmet from Photomedex, Montgomeryville, PA will be used.
~18 LED pods are in the helmet. Each LED pod:
~Pod size: 19 cm2 Power output: 692.5 mW Power density: 36.5 mW/cm2
~20 NIR diodes, 830 nm and 4 red diodes, 633 nm.
~1 J/cm2 = 30.4 sec"
16073547|NCT02356848|Behavioral|Tailored Intervention (TI)|Participants in this arm will receive a comprehensive intervention based on the Transtheoretical Model and Prospect Theory with the counseling being delivered by health counselors using MI principles.
16073548|NCT02356848|Behavioral|Current Practice (CP)|this group will receive calls and mailings focusing on providing education and prevention strategies for health conditions such as colorectal cancer, influenza, insomnia, vision, dementia, and oral disease.
16073549|NCT02356835|Device|APT001|APT001, is a portable device that uses plasma energy to deliver nitric oxide to the tissues.
16073550|NCT02356835|Device|SHAM|Portable device that uses warmed room air to mimic delivery of the APT001 treatment.
16073551|NCT02356822|Other|Patient registry|Oncology data registry
16073552|NCT02356809|Drug|Neovasculgen|Neovasculgen is an original gene construction that contains supercoiled plasmid DNA (1.2 mg) that encodes pCMV-vegf165 as the active substance. The drug will be supplied to the study centre as a sterile lyophilisate that will be then dissolved in 2 ml of water for injections immediately prior to administration. The drug will be administered intramuscularly (interosseous muscles of hand) at 4-5 injection sites in the dorsal surface of the hand.
16073553|NCT02356796|Other|Multidisciplinary group treatment|"Multidisciplinary group intervention at the University Hospital of North Norway. The group intervention is led by physiotherapists, with contributions from a gynecologist, nutritionist and a peer patient. The treatment consists of active exercises and theory lessons. The focus is to enhance the participants body awareness and to recognize the integration of mental and physical processes. The aim is to create change in patterns that influence the participants health negatively.
~The treatment lasts one year. The first meeting has a duration of 10 days, then follow-up after 3, 6 and 12 months."
16073554|NCT02356796|Other|Standard physiotherapy treatment|Standard treatment in primary or secondary health care physiotherapy. Patients are referred to a physiotherapist with appropriate training/competence, as close to their home as possible.
16073555|NCT02356783|Device|Pedometer|Wireless pedometer
16073556|NCT02356770|Device|Collagen Matrix 10808|At the day of the Intervention (day 0) sulcular incisions will be made around the neighbouring teeth and a straight incision from the lingual/palatal line angle of the distal tooth to the lingual/palatal line angle of the mesial tooth. A full thickness flap will be elevated on the lingual side, whereas a split flap will be made at the buccal aspect preparing a soft tissue pouch without the preparation of horizontal release incisions. The Collagen Matrix 10808 will then be positioned in the pouch under the elevated buccal flap. A horizontal mattress suture will be made to immobilize graft to the flap followed by four to five single sutures to close the wound.
16073557|NCT02356770|Procedure|Connective tissue graft|At the day of the Intervention (day 0) sulcular incisions will be made around the neighbouring teeth and a straight incision from the lingual/palatal line angle of the distal tooth to the lingual/palatal line angle of the mesial tooth. A full thickness flap will be elevated on the lingual side, whereas a split flap will be made at the buccal aspect preparing a soft tissue pouch without the preparation of horizontal release incisions. The Connective tissue graft (Gold Standard) will then be positioned in the pouch under the elevated buccal flap. A horizontal mattress suture will be made to immobilize graft to the flap followed by four to five single sutures to close the wound.
16073560|NCT02356744|Other|Ultrasound|Ultrasound assessment of fetal growth, anomalies , liqour and placenta
16073561|NCT02356718|Behavioral|Cognitive training activities|Training activities consist of computer tasks designed to improve memory and cognition. The intervention consists of 45-minute training sessions delivered regularly during inpatient treatment.
16073562|NCT02356718|Behavioral|Inpatient psychosocial therapy|Group psychosocial therapy delivered in an inpatient setting.
16073564|NCT02356705|Drug|xylocaine|intransal xylocaine given in conjunction with intranasal midazolam
16073565|NCT02356705|Drug|saline placebo|intranasal saline given as placebo
16073566|NCT02356692|Device|enfilcon A|Test lens
16073567|NCT02356692|Device|senofilcon A|Control lens
16073568|NCT02356679|Drug|Eupasidin-s Tab|three times per day, 1 tab for each time, PO, during 2weeks
16073569|NCT02356679|Drug|Stillen Tab.|three times per day, 1 tab for each time, PO, during 2weeks
16073570|NCT02356653|Device|Transplant of stem cells with CD3+/CD19+ depletion (CliniMACs)|Processing of stem cells using the CliniMACs device to selectively deplete specific T cells to decrease risk of graft versus host disease when using donor stem cells which are not fully matched.
16073571|NCT02356640|Procedure|EUS-guided celiac ganglion neurolysis|EUS-CGN would be performed with a linear video echoendoscope (Olympus UM 2000; Olympus Co Ltd, Japan). The celiac ganglia are visualized under linear EUS and the injection would be applied directly into the ganglia. It is represented by small 2 to 3 mm hypoechoic nodules with hyperechoic foci in the center or a single elongated hypoechoic structure. IIf the ganglia are not identified by EUS, then injection would be performed as bilateral injections at the celiac vessel trunk. All procedures would be performed by a two experienced endosonographer.
16073572|NCT02356640|Procedure|Percutaneous celiac plexus neurolysis|Percutaneous fluoroscopy-guided CPN would be performed in the operation theatre with the transcural technique. A 22-gauge, 17 cm-long spinal needle (B-D Quincke Type Point, Becton Dickinson &Co., NJ 07417, USA) would be inserted and advanced just caudal to the margin of 12th rib and cephalad to the transverse process of L1 toward the anterolateral surface of the L1 vertebral body. Final needle position would be confirmed by radiographic contrast, layering over anterior surface of aorta. 10mL of levobupivacaine (0.25%), followed by 10mL of absolute alcohol would be injected on both sides using separate punctures.
16073573|NCT02356640|Device|Olympus UM 2000|
16073574|NCT02356640|Device|B-D Quincke Type Point|
16073575|NCT02356640|Drug|Levobupivacaine|
16073576|NCT02356627|Other|The Cancer Home Life Intervention|Adaptive interventions aiming at compensating for functional limitations.
16073577|NCT02356588|Drug|Sufentanil Tablet 30 mcg|
16073578|NCT02356588|Drug|Placebo Tablet|
16073579|NCT02356575|Other|Acupuncture|
16073580|NCT02356575|Other|Cognitive Behavior Therapy|
16073581|NCT02356562|Drug|ombitasvir/paritaprevir/ritonavir and dasabuvir|tablet, ombitasvir coformulated with paritaprevir and ritonavir; tablet, dasabuvir
16073582|NCT02356562|Drug|Sofosbuvir|tablet
16073583|NCT02356562|Drug|Ribavirin|tablet
16073584|NCT02356549|Behavioral|EMR Tailoring|Electronic Medical Records (EMR) data alone will be entered into the Michigan Tailoring System (MTS system) and their brochures will be prepared.
16073585|NCT02356549|Behavioral|Survey Tailoring|Survey that will use standardized, psycho-metrically sound measures to gather information about patients, including their levels of trust in medical research and preferences for information and decision involvement. The survey augmented by their EMR data will be used to develop a level of tailored messages.
16073586|NCT02356549|Behavioral|Physician Involvement|Prior to the consultation, physicians of patients will receive a summary of patients' tailored message brochure from the Research Assistant (RA) and included in the patient's notes. At the conclusion of the consultation, the RA will ask the oncologist whether or not a clinical trial was discussed and whether or not they read the patients brochure.
16073587|NCT02356536|Device|Agilitas|WCD trial
16073588|NCT02356510|Procedure|Primary PCI|
16073589|NCT02356471|Device|Management of Therapy Complications Fitbit Zip (portable pedometer device)|Use pedometer to monitor physical activity
16073590|NCT02356471|Other|Questionnaire Administration|Ancillary studies
16073591|NCT02356471|Other|Quality-of-Life Assessment|Ancillary studies
16073592|NCT02356458|Drug|Ibrutinib|"Combination therapy:
~Trial treatment of ibrutinib in combination with bortezomib Cycles 1-6 (1 cycle = 21 days) Ibrutinib: p.o daily; Phase I: according to DL; Phase II: RP2D established in phase I
~Maintenance therapy:
~p.o daily: 560 mg"
16073593|NCT02356458|Drug|bortezomib|"Combination therapy:
~Trial treatment of ibrutinib in combination with bortezomib Cycles 1-6 (1 cycle = 21 days) Injection of Bortezomib (s.c.), dose of 1.3 mg/m2 on day 1, 4, 8, 11"
16073594|NCT02356445|Other|Cytotoxic drug|Observe patients versus treatment type
16073595|NCT02356419|Drug|Recombinant erythropoietin stimulating protein|Recombinant erythropoietin stimulating protein is a high glucose medium and long-acting recombinant protein products, containing 165 amino acids by adding 3 glycosylation sites
16073596|NCT02356406|Radiation|Celiac Plexus Radiosurgery|"5 fractions of SBRT (Stereotactic body radiation therapy). The target will always include the anterior-medial aspect aorta at T12-L2 (surrogate for celiac plexus). If there is adjacent tumor (e.g. pancreatic tumor that infiltrates the celiac plexus) this will be irradiated in addition.
~It is expected that patients will be treated with a rapid-arc IMRT (Intensity modulation radiation therapy) dose-painting technique. Details of beam arrangement and energy used will be determined on an individual basis."
16073597|NCT02356380|Other|Mobilization Type|"Group One: Mobilization Group: this group will receive grade 1,2,3,or 4 mobilization in prone based on the PT's clinical judgement. The treatment parameters will be recorded.
~Group Two: Grade 3-4 mobilization group: this group will receive a grade 3-4 mobilization, for 30 seconds form the first through sixth thoracic vertebrae."
16073598|NCT02356367|Other|telemonitoring|
16073599|NCT02356354|Procedure|Skin biopsy|2 biopsies are done on the same patient : 20 cutaneous biopsies from post-burn scar and from healthy skin
16073600|NCT02356341|Device|NovaTears® Eye Drops|Topical eye drops for lubrication of the ocular surface
16073601|NCT02356328|Device|NovaTears® Eye Drops|Topical eye drops for lubrication of the ocular surface
16073602|NCT02356315|Other|Functional Magnetic Resonance Imaging|Functional magnetic resonance imaging will be performed to measure brain, brainstem, and spinal cord activity.
16073607|NCT02356289|Drug|Placebo|
16073608|NCT02356289|Drug|MYK-461|
16073609|NCT02356276|Procedure|D2 lymphadenectomy|
16073610|NCT02356276|Procedure|Hyperthermic Intraperitoneal Chemotherapy|The first HIPEC is conducted within 48 h after surgery: Normal saline 3000 -4000ml, Paclitaxel 75mg/m^2, 43°C, 60min. The second HIPEC is performed after 24 hours of the first HIPEC. The regimens are Paclitaxel 100 mg/m^2, 43°C, 60min.
16073611|NCT02356276|Drug|Systemic chemotherapy (XELOX or SOX regimens)|"XELOX regimen: Oxaliplatin: 130 mg/m^2, IV, d1; Capecitabine: 1 g/m^2 bid, days 1-14, every 3 weeks for a total of 6-8 cycles.
~SOX regimen: Oxaliplatin: 130 mg/m^2, IV, d1; S-1, 40 mg/m^2 bid, po, day 1-14 (S-1: BSA <1.25m^2, 40mg bid, 1.25m^2≤ BSA ≤1.5m^2, 50mg bid, BSA>1.5m^2, 60 mg bid) bid, d1-14, po, every 3 weeks for a total of 6-8 cycles."
16073612|NCT02356237|Other|No episiotomy|Avoidance of episiotomy
16073613|NCT02356224|Drug|SHR3824|A tablet of 2.5 mg, 5 mg, 10 mg, 25 mg, 50mg, 100mg, 200 of SHR3824 taken for single dose.
16073614|NCT02356224|Drug|Placebo|A tablet of 2.5 mg, 5 mg, 10 mg, 25 mg, 50mg, 100mg, 200 of Placebo taken for single dose.
16073615|NCT02356211|Other|Multifactorial Falls Assessment|The Geriatric Multifactorial Falls Assessment Clinic is a component of GERIATRIC-PACT, a frail-elderly primary care patient-centered medical home with care provided by an inter-professional teamlet consisting of a geriatrician, geriatric nurse practitioner, clinical pharmacist, licensed practical nurse, nurse care manager, social worker, and dietitian. GERIATRIC-PACT operates with increased ancillary support compared to Primary Care PACT. Falls assessment patients were referred by primary care providers and were evaluated and treated by the GERIATRIC-PACT teamlet, including ordering of tests and medication adjustment, with an average of two visits and active follow-up for one year.
16073616|NCT02356198|Drug|EXPAREL|transversus abdominis plane injection
16073617|NCT02356198|Drug|Intrathecal hydromorphone|Intrathecal opioid administration
16073625|NCT02356146|Drug|Tacrolimus C12|
16073626|NCT02356120|Other|Echocardiogram|Tricuspid annular plane systolic excursion will by measured by emergency physician performed echocardiogram
16073627|NCT02356107|Drug|5-hydroxytryptophan and Creatine monohydrate|
16073628|NCT02356094|Procedure|Pentacam|Corneal topography using Scheimpflug Pentacam examination
16073629|NCT02356081|Other|ASyMS intervention Group|ASyMS is a mobile phone-based remote-monitoring system that enables the 'real-time' monitoring of patients' symptoms through use of a patient-reported outcome measure (PROM)
16073630|NCT02356068|Other|ROTEM analysis|3 blood samples for ROTEM analysis
16073631|NCT02356055|Behavioral|STOMP (Skill-building through Task-Oriented Motor Practice)|The STOMP intervention is a package including family-centered goals, task-specific training delivered through motor learning and errorless learning principles. It is unique in the use of massed practice (high-dosage) therapy.
16073632|NCT02356042|Other|Geriatric inclusive art (GIA) activity|The frequency of GIA sessions in this study was from 1 to 2 per month. The time of a session was around 1 hour 30 minutes. Participants of intervention group benefited GIA activity during a 6-month follow-up period.
16073633|NCT02356016|Behavioral|WB-EMS Intervention|Supervised WB-EMS Intervention 18 min/session (one session/week) and monthly dietary counseling for 6 months
16073634|NCT02356016|Behavioral|WB-EMS-Intervention and dietary supplementation|Supervised WB-EMS Intervention and dietary supplementation and monthly dietary counseling for 6 months
16073635|NCT02356016|Other|control (dietary counseling)|Monthly dietary counseling only
16073636|NCT02356003|Device|Low frequency repetitive transcranial magnetic stimulation|Baseline high-resolution anatomical magnetic resonance images will allow individualized neuronavigation (Brainsight 2, Rogue Research, Montreal QC) to co-register the transcranial magnetic stimulation Airfilm coil (Magistim, UK) precisely to the supplementary motor area as defined by functional magnetic resonance imaging. Interventional low frequency repetitive transcranial magnetic stimulation parameters will be: intensity 100% resting motor threshold, frequency 1 Hz, duration = 20 minutes (1200 stimulations). Treatments will occur on each weekday at the same time of day for three weeks (15 total). These are standard parameters for low frequency repetitive transcranial magnetic stimulation and are well tolerated in children.
16073637|NCT02355990|Procedure|Minimally Invasive Micro Sclerostomy|Creation of a drainage channel of 50 - 100 microns (diameter) at the sclera-corneal junction and extending from the anterior chamber to the interface between the sclera and the conjunctiva (subconjuctival space).
16073638|NCT02355977|Drug|minocycline|Periocline dental ointment
16073639|NCT02355977|Procedure|surface and root planning|surface and root planning
16073640|NCT02355964|Behavioral|Exercise|Aerobe exercise 3 times a week in 8 weeks
16073641|NCT02355964|Behavioral|Diet|Diet (a diet with an overall high protein content and a low glycemic index) in 8 weeks
16073642|NCT02355951|Other|blood draw|
16073643|NCT02355938|Drug|Fidaxomicin 200 mg|Fidaxomicin 200 mg every 12 hours
16073644|NCT02355938|Drug|Placebo|1 dose of placebo every 6 hours x 2 doses
16073645|NCT02355938|Drug|Vancomycin|Vancomycin 125 mg every 6 hours
16073646|NCT02355925|Drug|intrauterine injection of uhCG|40 μL of tissue culture medium (G.2plus ref. 10132, Vitrolife) containing either 500 IU of hCG (Choriomon®, IBSA SA, Switzerland) is injected intrauterine, approximately 7 minutes before embryo transfer.
16073647|NCT02355925|Drug|Placebo|only 40 μL of tissue culture medium (G.2plus ref. 10132, Vitrolife) is injected intrauterine, approximately 7 minutes before embryo transfer.
16073648|NCT02355925|Other|control|the embryonic transfer is done without the intrauterine hCG injection. The ET procedure is performed just like in the other two groups.
16073649|NCT02355912|Device|Powered knee and ankle prosthesis|A powered knee and ankle prosthesis developed by Vanderbilt University.
16073650|NCT02355899|Drug|PD P 506 A|PD P 506 A is a dermal patch of 4 cm² in size loaded with 2 mg 5-ALA (as 5-ALA HCl) per cm².
16073651|NCT02355886|Drug|Gabapentin|Given PO
16073652|NCT02355886|Other|Placebo|Given PO
16073653|NCT02355886|Other|Questionnaire Administration|Ancillary studies
16073654|NCT02355873|Device|AN69ST hemofilter|
16073655|NCT02355873|Device|AN69 hemofilter|
16073656|NCT02355860|Behavioral|assessment|assessment
16073657|NCT02355847|Other|Lectures|Lectures
16073658|NCT02355834|Other|IBD nurse intervention|Two IBD nurse specialists at each centre (8 in total) will deliver the IBD nurse intervention
16073659|NCT02355821|Drug|Moxonidine|0.4 mg moxonidine QD titration up to 0.6 mg moxonidine BID Other Names:perindopril 10 mg/day (optional); losartan 50 mg/day (optional); calcium carbonate; vitamin D
16073660|NCT02355821|Drug|Bisoprolol|5 mg Bisoprolol QD titration up to 7.5 mg Bisoprolol BID Other Names: perindopril 10 mg/day (optional); losartan 50 mg/day (optional); calcium carbonate; vitamin D
16073661|NCT02355808|Behavioral|Tailored Leaflet|
16073662|NCT02355808|Behavioral|GP visit|
16073663|NCT02355795|Behavioral|low-fat diet|Energy from total fat, protein and carbohydrates are 20%, 14% and 66%, respectively
16073664|NCT02355795|Behavioral|moderate-fat diet|Energy from total fat, protein and carbohydrates are 30%, 14% and 56%, respectively
16073665|NCT02355795|Behavioral|high-fat diet|Energy from total fat, protein and carbohydrates are 40%, 14% and 46%, respectively
16073666|NCT02355782|Biological|OMS721|Human IgG4 MASP-2 Monoclonal Antibody
16073667|NCT02355756|Drug|Maxadilan|
16073668|NCT02355756|Drug|Placebo|
16073669|NCT02355743|Drug|rtPA lock therapy|"rtPA 2 mg/2 ml, or 110% of the volume of the catheter lumen if less than 2 mL, administered locally in a volume to fill the lumen (dead space) of the CVAD, once weekly for a total of 24 weeks. rtPA will be given as research intervention as lock therapy in that it will dwell within the catheter of the CVAD for a specified duration of time and then be removed (aspirated); in this setting the medication is not given to the patient as a flush, i.e. in systemic fashion."
16073670|NCT02355730|Procedure|Venepuncture|Venepuncture to collect blood samples from Patients undergoing Warfarin Therapy.
16073671|NCT02355717|Other|Observational Study|
16073672|NCT02355704|Drug|Atorvastatin|Patients were assigned to two groups, one of them received oral atorvastatin (study group) and the other, homologated placebo (control group) for 4 weeks before a kidney transplantation. Previous surgical procedure controls were performed
16073673|NCT02355704|Drug|Placebo|Patients were assigned to two groups, one of them received oral atorvastatin (study group) and the other, homologated placebo (control group) for 4 weeks before a kidney transplantation. Previous surgical procedure were performed
16073674|NCT02355691|Device|PREVENA|The device is a sealed negative pressure wound therapy tool. The device will be placed on the skin during surgery and left in place until their followup at 7 days.
16073675|NCT02355678|Drug|dexamethasone|IV 0.5 mg/kg
16073676|NCT02355678|Drug|Local anesthetic infiltration|Using 25 G-3.5 cm curved needle
16073677|NCT02355678|Drug|General anesthesia|"Induction by intravenous fentanyl (1.5 µg kg-1) and propofol (2.5 mg kg-1) followed by endotracheal intubation facilitated by atracurium (0.5 mg kg-1).
~Maintenance with sevoflurane 1-3%, fentanyl (1-2 µg kg-1), nitrous oxide 70% and oxygen 30%."
16073678|NCT02355678|Procedure|Tonsillectomy|Mono-polar electrocautery or cold dissection
16073679|NCT02355678|Procedure|gastric content suction|By orogastric tube
16073680|NCT02355678|Drug|Tramadol hydrochloride|If Visual Analogue Scale was greater than 5
16073681|NCT02355678|Drug|Propacetamol hydrochloride|If Visual Analogue Scale was between 4 and 5
16073682|NCT02355678|Drug|Paracetamol Suppository|If Visual Analogue Scale was less than 4
16073683|NCT02355665|Drug|Nicotine Spray|Nicotine Spray
16073684|NCT02355665|Drug|Placebo|Placebo to match nicotine spray
16073685|NCT02355652|Device|Surgical total knee replacement using cemented components|Each patient of this arm will go under a surgical procedure of total knee replacement (or total knee arthroplasty) using cemented femoral and tibial prosthetic components.
16073686|NCT02355652|Device|Surgical total knee replacement using uncemented components|Each patient of this arm will go under a surgical procedure of total knee replacement (or total knee arthroplasty) using uncemented femoral and tibial prosthetic components.
16073687|NCT02355639|Drug|Clobetasol propionate 0.05 % ointment|
16073688|NCT02355639|Drug|Betamethasone dipropionate 0.064 % ointment|
16073689|NCT02355639|Drug|Petrolatum ointment|
16073690|NCT02355613|Radiation|Radiosurgery with Gamma Knife Perfexion|Gamma Knife Radiosurgery is a very precise form of therapeutic radiology. Even though it is called surgery, a Gamma Knife procedure does not involve actual surgery but it uses 192 isocentric beams of highly-focused gamma rays (60-Co) to treat small to medium size lesions. Minimum beam size is 4 mm. This procedure is frame based.
16073691|NCT02355613|Radiation|Linac-based Radiosurgery with EDGE|EDGE linear accelerator from Varian (Varian, Palo Alto, USA) is a C-arm machine specifically developed for radiosurgery frameless treatment. The characteristics of this linac are a high level of precision and the possibility to include multiple positioning systems for stereotactical treatments, among which Cone Beam CT (CBCT), the Optical Surface Monitoring System (OSMS), and Calypso.
16073692|NCT02355600|Other|Oocyte retrieval|Tamoxifen given at a fixed dose for invasive breast cancer adjuvant hormonotherapy or for breast cancer prophylaxis.
16073693|NCT02355561|Drug|JNJ-54861911 (Treatment A)|Participants will receive a single oral 25 mg formulation 1 of JNJ-54861911 tablet as Treatment A under fasted conditions in one of the treatment periods.
16073694|NCT02355561|Drug|JNJ-54861911 (Treatment B)|Participants will receive a single oral 25 mg formulation 2 of JNJ-54861911 tablet as Treatment B under fasted conditions in one of the treatment periods.
16073695|NCT02355561|Drug|JNJ-54861911 (Treatment C)|Participants will receive a single oral 25 mg formulation 2 of JNJ-54861911 tablet as Treatment C under fed conditions in one of the treatment periods.
16073696|NCT02355548|Other|Outpatient Treatment of Pulmonary Embolism|Patients who participate in the study will be treated for their pulmonary embolism in an outpatient setting instead of being hospitalized.
16073697|NCT02355535|Drug|PAC-1|PAC-1 is taken orally on days 1-21 of a 28-day cycle.
16073698|NCT02355522|Drug|Intrauterine lidocaine|
16073699|NCT02355522|Drug|Lidocaine gel|
16073700|NCT02355522|Drug|KY jelly|
16073701|NCT02355522|Drug|Intrauterine normal saline|
16073702|NCT02355509|Drug|Acarbose|"Acarbose dose was progressively titrated (50 mg/day per week up to 150 mg/day) to reduce the known adverse effects of acarbose such as flatulence, bloating, diarrhea, abdominal pain.
~The treatment for three months"
16073703|NCT02355509|Drug|Placebo|Placebo pills are given instead of acarbose in this group
16073704|NCT02355496|Other|Displaying medicare fee data|Using the computerized order entry system to make medicare fee data for a randomly selected inpatient laboratory tests transparent to providers at the time of order entry.
16073705|NCT02355483|Device|Unenhanced abdominal Computed Tomography|Systematic Unenhanced abdominal Computed tomography
16073706|NCT02355470|Behavioral|GIFTSS|Universal education and brief counseling regarding sexual violence
16073707|NCT02355470|Behavioral|Brief alcohol use intervention|Brief education and counseling intervention to promote safer alcohol use, reduce binge drinking
16073708|NCT02355444|Dietary Supplement|blackberry polyphenol enriched beverage|Double-blind intervention study, cross-over design with one 250 mL bottle of high-dose blackberry polyphenol beverage per day or placebo (blackberry beverage with minimal polyphenol) in Phase one followed by cross-over in Phase two.
16073709|NCT02355444|Dietary Supplement|blackberry beverage with minimal polyphenol concentrations|Double-blind intervention study, cross-over design with one 250 mL bottle of high-dose blackberry polyphenol beverage per day or placebo (blackberry beverage with minimal polyphenol) in Phase one followed by cross-over in Phase two.
16073710|NCT02355431|Drug|Itacitinib|tablets to be administered by mouth once daily at dose selected from safety run-in phase
16073711|NCT02355431|Drug|erlotinib|150 mg tablets administered by mouth once daily at total daily dose of 150 mg
16073712|NCT02355431|Drug|placebo|matching placebo tablets to be administered by mouth at dose selected from safety run-in phase
16073713|NCT02355418|Procedure|Mitral valve repair|Standard mitral valve repair surgery
16073714|NCT02355405|Device|lung ultrasound|lung ultrasound investigations were performed right before and after the surgical procedure.
16073715|NCT02355405|Radiation|thoracic computed tomography|thoracic CT were performed within one hour after the LUS investigation
16073716|NCT02355392|Other|Telemedical home blood pressure measurements|
16073717|NCT02355379|Drug|LV5FU2 or capectitabine|
16073718|NCT02355379|Drug|FOLFOX4 or XELOX|
16073719|NCT02355379|Other|Observation|
16073720|NCT02355379|Drug|LV5FU2 or capecitabine|
16073721|NCT02355366|Behavioral|Family-Focused Therapy|Family Focused Therapy is a manual-based, psycho-educational intervention which is designed to reduce intra-familial stress, conflict, and affective arousal by enhancing communication and problem solving skills among families who are affected by bipolar disorder (Miklowitz et al., 2013). It concentrates on skills relevant to managing the prodromal stages of bipolar disorder, such as mood monitoring, reducing family conflict, improving problem solving, stabilizing daily routines and regulating sleep/wake cycles (Miklowitz, 2012).
16073722|NCT02355366|Behavioral|Brief Educational Treatment|Brief Educational Treatment will consist of 1 - 2 sessions involving both parents and adolescents; it will consist of diagnostic feedback following the adolescent's baseline assessment. It will provide families with information and strategies on tracking and managing adolescent mood disorders. Additionally, ongoing medication management and crisis family sessions will be available if required.
16073723|NCT02355353|Other|Experimental: imaging arm|DWI-MRI scans at baseline, at 14 days after first administration of chemotherapy and after up to 6 cycles of chemotherapy
16073724|NCT02355340|Other|Dual energy x-ray absorptiometry (DXA)|Subjects will undergo DXA scan to assess total body (less head) and lumbar spine bone mineral density.
16073725|NCT02355340|Other|Peripheral quantitative computed tomography (pQCT)|Subjects will undergo pQCT assessment of radius and tibia.
16073726|NCT02355327|Device|Laselle Kegel Exerciser|Participants use a vibrating pelvic floor muscle training ball for 12 weeks. The ball is inserted into the vagina and left for 15 minutes daily in the first week, and if well tolerated 30 minutes daily from the second week onwards. To achieve the vibrating effect, the balls are worn while moving - performing everyday tasks or going for a walk.
16073727|NCT02355327|Behavioral|Pelvic floor muscle exercises|Participants get standard care after childbirth, which is the routine recommendation of pelvic floor muscle exercises. Participants will be asked to continue/start the pelvic floor muscle exercises they routinely were recommended by customary written instructions from their health professionals after birth. Intervention duration for this study is 12 weeks.
16073728|NCT02355314|Other|Doppler-based renal|Doppler-based renal : day 0 and day 3
16073729|NCT02355314|Biological|blood sample and urine sample|blood sample and urine sample : day 0 and day 3
16073730|NCT02355301|Procedure|orthopedic|Compare the type of treatment chosen by the orthopedist with a functional assessment (ICF-WHO model)
16073731|NCT02355288|Procedure|Minimally Invasive Coronary Bypass|Bypass graft of the Left Anterior Descending (LAD) artery using minimally invasive cardiac surgery. MICS is a bypass surgery done with a small (4-6 cm) incision under the left breast, instead of the usual incision down the middle the chest.
16073732|NCT02355288|Procedure|Percutenous Coronary Intervention|Stenting of the Left Anterior Descending (LAD) artery using a drug-eluting stent.
16073733|NCT02355275|Procedure|Home Exercise Program|All patients will be provided with a Thera-Band® Loop and Band and handout describing home exercises to be performed 3 times a week for 4 weeks.
16073734|NCT02355262|Other|Informational Intervention|Receive CATCH-UP intervention
16073807|NCT02354703|Drug|Ondansetron|Ondansetron (0.33 mg) bid+ BBCET counseling
16073735|NCT02355249|Procedure|MIE|Minimally invasive thoracol-laparoscopic esophagectomy will be performed in this group.
16073736|NCT02355249|Procedure|OE|Patients will be treated with traditional three incisions esophagectomy.
16073737|NCT02355236|Drug|Naproxen/Esomeprazol 500/20mg|Tablet, b.i.d.
16073738|NCT02355236|Drug|Celecoxib 200mg|Capsule, o.d.
16073739|NCT02355236|Drug|Naxozol-Placebo|Tablet (which is identical to Naxozol), b.i.d.
16073740|NCT02355236|Drug|Comparator-Placebo|Capsule (which is identical to Celebrex), o.d.
16073741|NCT02355223|Other|FAST|See information in arm description
16073742|NCT02355210|Dietary Supplement|Bifidobacteria adolescentis BD1|packet containing 10^9 cells of Bifidobacteria adolescentis BD1
16073743|NCT02355210|Dietary Supplement|Bifidobacteria animalis subsp. lactis BB-12|packet containing 10^9 cells of Bifidobacteria animalis subsp. lactis BB-12
16073744|NCT02355210|Dietary Supplement|Bifidobacteria adolescentis BD1 and galactooligosaccharide|packet containing 10^9 cells Bifidobacteria adolescentis BD1 and 5 g galactooligosaccharide
16073745|NCT02355210|Dietary Supplement|Bifidobacteria animalis subsp. lactis BB-12 and galactooligosaccharide|packet containing 10^9 cells B animalis subsp. lactis BB-12 and 5 g galactooligosaccharide
16073746|NCT02355210|Dietary Supplement|galactooligosaccharide|5 g galactooligosaccharide
16073747|NCT02355210|Dietary Supplement|Placebo|lactose powder, 5 grams
16073748|NCT02355197|Drug|L-ascorbic acid|1 gram L-ascorbic acid (vitamin C …..) per day from the time of diagnosis until the time of delivery
16073749|NCT02355184|Drug|PRO 140 350mg weekly SQ injection.|CCR5 Antagonist
16073750|NCT02355158|Drug|clonidine hydrochloride topical gel, 0.1%|
16073751|NCT02355132|Other|Insurance Intervention|Random selection to apply for Medicaid coverage through Oregon Experiment drawings held between March and October 2008
16073752|NCT02355119|Drug|FOLFOXIRI|Combination of 5-Fluorouracil/Folinic Acid, Irinotecan, Oxaliplatin
16073753|NCT02355119|Drug|Gemcitabine|
16073754|NCT02355106|Device|PolarStart System|Atrial flutter Ablation
16073755|NCT02355093|Procedure|adductor canal block (ACB)|We performed an ultrasound survey at the medial part of the thigh，the needle is introduced in-plane and 2 to 3 mL of saline is used to ensure correct placement of the needle in the vicinity of the saphenous nerve in the adductor canal,the catheter is introduced and advanced 1 to 2 cm beyond the tip of the needle.The study medication is administered as an infusion of 0.2% ropivacaine at a rate of 5mL/h during the next 48 hours.
16073756|NCT02355093|Procedure|Femoral nerve block (FNB)|the catheter is inserted in-plane with the probe parallel to the inguinal crease, to obtain a short-axis view of the nerve. The correct needle placement is confirmed by injecting 2 to 3 mL of saline to cause tissue expansion below the iliac fascia, lateral to the femoral artery, and in the vicinity of the femoral nerve. The catheter is introduced 1 to 2 cm beyond the tip of the needle，an infusion of 0.2% ropivacaine at a rate of 5mL/h is administered during the next 48 hours.
16073757|NCT02355093|Drug|ropivacaine|
16073758|NCT02355080|Behavioral|On-site bundled rapid HIV/HCV testing|Participants will be offered bundled on-site rapid HIV and HCV testing with post-test counseling that addresses both sexual and drug use risk reduction, and linkage to care.
16073759|NCT02355080|Behavioral|Standard of care (SOC)|Participants will receive the SOC for HIV and HCV testing at the study sites.
16073760|NCT02355067|Behavioral|Social Media Intervention|These women will participate in the intervention through the online Facebook group.
16073761|NCT02355067|Behavioral|Traditional In-Person Intervention|These women will participate in the intervention through a traditional weekly meeting of a group in-person.
16073762|NCT02355054|Drug|C-11 Choline PET Imaging|Patients will receive IV injection of C-11 Choline followed by imaging from the base of the brain to the upper thigh on a PET/CT or a PET/MRI scanner
16073763|NCT02355041|Behavioral|Meal Replacement-based Weight Loss Diet|
16073764|NCT02355041|Behavioral|Educational Video|Via information presented by medical professionals and lifestyle experts, this film delves into issues related to preventing and combating obesity through healthy lifestyle changes. Major topics include the importance of healthy eating and exercise behaviors and the changes that can be made by communities to reshape our lifestyles. Potential community changes are further addressed with respect to schools by presenting particularly successful programs that have been implemented in some schools. Participants will stream it free on the web.
16073765|NCT02355028|Drug|LHA510 ophthalmic suspension|
16073766|NCT02355028|Drug|LHA510 vehicle|Inactive ingredients used as a placebo comparator
16073767|NCT02355028|Drug|Ranibizumab ophthalmic solution|For intravitreal (IVT) injection
16073768|NCT02355002|Device|Transcranial Magnetic Stimulation|Transcranial magnetic stimulation uses a rapidly changing magnetic field to induce current in brain tissue non-invasively. It is common procedure in both clinical and research settings, and it has well established guidelines for safe an ethical use which maximize safety for all subjects. See attached Rossi et. al. 2009 as a reference to safety guidelines for TMS.
16073769|NCT02354989|Device|Rate Response on first (VVI biventricular pacing)|Rate Response function is turned on in the device. The patients performs a 6 minute walking test. After a week Rate Response function is turned off and the patient performs a second 6 minute walking test.
16073770|NCT02354989|Device|Rate Response off first (VVI biventricular pacing)|Rate Response function is turned off in the device. The patients performs a 6 minute walking test. After a week Rate Response function is turned on and the patient performs a second 6 minute walking test.
16073771|NCT02354976|Drug|Placebo|Placebo matching to Omega-3 carboxylic acids (olive oil)
16073772|NCT02354976|Drug|Omega-3 carboxylic acid|4 g administered as 4 x 1 g capsules
16073773|NCT02354976|Drug|Fenofibrate 200mg|200mg capsule administered once daily
16073774|NCT02354976|Drug|Placebo|Placebo matching to fenofibrate 200mg
16073775|NCT02354963|Procedure|In vitro fragmentation of the ovarian tissue|Unilateral ovarian cortex extraction, in vitro fragmentation and reimplantation.
16073776|NCT02354950|Drug|GSK1265744 30mg|GSK1265744 30mg tablets are white to almost white coated oval tablets. All subjects will receive GSK1265744 30mg as a single oral dose in the fasted state followed by PK sampling.
16073777|NCT02354937|Drug|GSK1265744 30 mg|White to almost white coated oval tablets with unit dose strength of 30 mg for oral administrations.
16073808|NCT02354703|Drug|Placebo|Placebo + BBCET counseling
16073778|NCT02354924|Device|Biofinity soft contact lens|Biofinity soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.
16073779|NCT02354924|Device|Visco soft contact lens|Viso soft contact lens on two eyes and follow up for 3 months (90 days). It is necessary to remove contact lenses every day and replace after 30 days.
16073780|NCT02354911|Biological|Immunoregulatory Dendritic Cells|Autologous dendritic cells harvested by leukapheresis and engineered ex vivo via incubation with antisense DNA oligonucleotides targeting the primary transcripts of CD40, CD80 and CD86. The ex vivo engineered product is then administered via blinded intradermal injection in the peri-umbilical region of the abdomen given as 4 separate injections at 2-week intervals (~10 million cells/injection).
16073781|NCT02354911|Other|Placebo Comparator: Placebo Control|Blinded intradermal injections in the peri-umbical region of the abdomen given as 4 separate injections at 2-week intervals
16073782|NCT02354898|Drug|BBI503|
16073783|NCT02354898|Drug|Sorafenib|Sorafenib 400mg twice daily (800mg total daily dose)
16073784|NCT02354885|Drug|Tranexamic Acid|Coagulation Management / Efficiency
16073785|NCT02354872|Drug|Nicotine Mini-Lozenge|If randomized to only the Nicotine Mini-Lozenge condition: Participants randomized to this condition will receive up to a 12 month supply of 2 mg or 4 mg nicotine mini-lozenges. Mini-Lozenges will be given at the initial visit and over the course of the whole study. Participants will be instructed to use 9 pieces daily for the 12 months.
16073786|NCT02354872|Behavioral|Behavioral Reduction Counseling|We will deliver BR in 10 (10-15 minute) sessions over a 52-week period, with an in-person session at Visit 1 followed by nine phone counseling sessions. Sessions are front-loaded to enhance acquisition of new behaviors. BR Counseling will emphasize the development of smoking control skills via feasible, specific, and graded assignments of smoking reduction activities that will be tracked over time. BR will also emphasize competence and self-efficacy, both which will be directly linked to the practice of smoking reduction skills and success in smoking control. The health counselor will provide rationales for the reduction intervention, why reduction (e.g., eliminating smoking contexts) should help the smoker, and provide the participant with specific exercises and goals. The health counselor will explicitly address pragmatic issues such as work contexts, smoking policies, and habits that interfere with smoking reduction efforts.
16073787|NCT02354872|Behavioral|5Rs Motivation Counseling|"The 5Rs Motivation Counseling will be delivered in four (10-15 min) sessions over a 52-week period. Participants in the on condition will receive three brief phone sessions over the year to prompt processing of motives for smoking reduction or cessation. The health counselor and smoker will discuss: 1) Relevance of smoking to the individual; 2) Risks of continued heavy smoking; 3) Rewards of quitting and significant reduction; and 4) Roadblocks to success; and will do so on a 5) Repeated basis. The discussion will follow the general principles of MI: counselors will use strategies that are nonauthoritarian, nonconfrontational, supportive, and use open-ended questions."
16073788|NCT02354872|Behavioral|Behavioral Activation Counseling|The BA treatment will be delivered in 10 (10-15 minute) sessions over a 52-week period starting with Visit 1 followed by nine phone counseling sessions. This BA treatment will be modeled after Behavioral Activation for quitting smoking, but made relevant for smoking reduction. Treatment goals focus on helping participants engage in positively reinforcing activities while not smoking. The treatment includes: 1) a rationale for the BA exercises as they relate to smoking (e.g., engaging in non-smoking reinforcers will provide other sources of pleasure and assist with cutting down); 2) assessment of the participant's goals, values, and reinforcing value of current nonsmoking activities; 3) training in self-monitoring using an activity log; 4) ongoing assignments of activities that should significantly increase the participant's nonsmoking reinforcement and create broader lifestyle and cue exposure changes; and 5) problem-solving to address obstacles to goal attainment.
16073789|NCT02354872|Other|No Treatment|No Treatment
16073790|NCT02354859|Drug|Gallium nitrate|Study subjects will receive an infusion of either placebo or gallium nitrate.
16073791|NCT02354859|Drug|Normal Saline|Study subjects will receive an infusion of either placebo (normal saline) or gallium nitrate.
16073792|NCT02354833|Drug|Phenylephrine|
16073793|NCT02354833|Drug|Norepinephrine|
16073794|NCT02354820|Other|Evidence Based Constipation Reminders|
16073795|NCT02354807|Drug|Mirabegron|One-time dose of 100mg of Mirabegron
16073796|NCT02354807|Other|Cold exposure|Exposure of subjects to cold temperature to induce non-shivering thermogenesis
16073797|NCT02354794|Dietary Supplement|One form of arginine|3 capsules containing 0.5g of one form of L-arginine (1.5g) 3 times daily (4.5g per day) for 1 month
16073798|NCT02354794|Dietary Supplement|placebo|3 capsules containing 0.5g cellulose (non active product) 3 times daily (4.5g per day) for 1 month
16073799|NCT02354781|Biological|rAAV1.CMV.huFollistin344|Six DMD patients will receive rAAV1.CMV.huFollistatin344 to both limbs by multiple injections to gluteal muscles, quadriceps and tibialis anterior muscles.
16073800|NCT02354768|Drug|Effects of lanreotide with current anti-diarrheal treatments (diosmectite and loperamide)|
16073801|NCT02354768|Drug|Effects of current anti-diarrheal treatments (diosmectite and loperamide) alone|
16073802|NCT02354755|Device|Psychomotor vigilance test (PVT|The Psychomotor Vigilance Task Monitor is a hand-held, self-contained system used for repetitive reaction time measurements. The device measures the speed with which subject responds to visual stimulus (by pressing a response button).
16073803|NCT02354742|Other|Echo guided fluid resuscitation|Patients will have their fluid resuscitation care guided by measurements obtained during an echo.
16073804|NCT02354742|Other|EGDT fluid resuscitation|Patients will have their fluid resuscitation care guided by an EGDT protocol, which is currently used as standard of care.
16073805|NCT02354729|Other|Behavioral Economics|Use financial incentives to promote epinephrine-carrying.
16073806|NCT02354716|Device|EndoFLIP|The Endolumenal Functional Lumenal Imaging Probe Imaging System is a technology developed to measure the dimensions & function of a variety of hollow organs throughout the body. Since receiving FDA clearance for sale in the United States EndoFLIP has been used in a variety of clinical applications. We intend to investigate the potential clinical applications of EndoFLIP in the upper GI tract in patients with esophageal stenoses who require endoscopic therapy for benign esophageal strictures. The use of EndoFLIP to characterize a stricture pre- & post- dilation may offer insight in to the clinical and endoscopic predictors of successful stricture dilation, & what characteristics determine & predict refractory & recurrent strictures.
16073809|NCT02354690|Drug|Vemurafenib|Vemurafenib is used to treat patients with BRAF mutated metastatic melanoma. Patients will start treatment in a dose of 960 BID 7 days before tumor harvest and ends at the day of admission (day -8).
16073810|NCT02354690|Drug|Lymphodepleting chemotherapy|First patients undergo lymphodepleting chemotherapy regimen consisting of cyclophosphamide 60 mg/kg for 2 days and fludarabine 25 mg/m2 for 5 days (constitutes day -7 to -1 of admission).
16073811|NCT02354690|Drug|TIL infusion|"7 days after start of vemurafenib treatment, patients undergo surgery to removal of a tumor in order to isolate, activate and expand tumor infiltrating lymphocytes (TIL) to high numbers. In vitro preparation usually takes 4-6 weeks using the young TIL method.
~On day 0 patients receive an infusion of TIL (1x10e9-2x10e11 cells)."
16073812|NCT02354690|Drug|Interleukin-2|After infusion of TILs, patients will receive interleukin-2 infusions according to the decrescendo regimen (18 MIU/m2 for 6 hours, 18 MIU/m2 for 12 hours, 18 MIU/m2 for 24 hours followed by 4,5 MIU/m2 for another 3 x 24 hours)
16073813|NCT02354677|Other|In vitro experiments on bronchial epithelial cells|
16073814|NCT02354664|Other|Thoracic MRI|Imaging of the diaphragm will be completed during resting breathing, and then during a maximal voluntary ventilation maneuver.
16073815|NCT02354664|Other|Spirometry|Upright forced vital capacity (FVC)
16073816|NCT02354664|Other|Inspiratory Load Compensation|A spring-loaded pressure device will resist inspiration. The patient must generate the threshold inspiratory pressure to receive airflow. The changes in breathing timing, flow and volume will be recorded.
16073817|NCT02354664|Other|Maximal Inspiratory Pressure|Measure the maximal airflow on inhalation
16073818|NCT02354664|Other|Resting Breathing Pattern|The breathing pattern will be assessed when the subject is seated and in a relaxed state.
16073819|NCT02354664|Other|Respiratory Muscle Endurance Test|Evaluates the time limit that a participant can maintain ventilation while breathing with a submaximal inspiratory threshold load.
16073820|NCT02354651|Other|Resting breathing pattern|Record resting ventilatory flow and timing
16073821|NCT02354651|Other|Phrenic nerve stimulation|
16073822|NCT02354651|Other|Maximal inspiratory pressure|Measure the maximal airflow on inhalation
16073823|NCT02354651|Other|Forced expiratory testing|Measure the maximal airflow and volume of gas that can be exhaled with the subject breathing or coughing forcefully
16073824|NCT02354651|Other|EMG|Evaluate electrical activity of diaphragm via pacer
16073825|NCT02354638|Behavioral|Tobacco users|Various tobacco cessation interventions in the form of one to one counseling, focus group discussions, role plays, games etc. will be used in the tobacco users.
16073826|NCT02354638|Drug|Pharmacotherapy|"Pharmacotherapy will also be prescribed as per the need assessment consisting of:
~Nicotine Chewing Gums:
~Dose: 2 mg/4 mg, 10-15 pieces per day with maximum dose of 24 pieces/day depending on cravings.Total Duration: 12 weeks Duration of treatment: Higher dose for 4-6 weeks, with weaning till 2-3 months
~Nicotine Transdermal patches:
~Dose: 7 mg/10 mg/14 mg/21 mg -for 24-hours use. Total Duration: 12 weeks Duration of treatment: Higher strength patch for 2 weeks and depending on cravings will be gradually decreased till 4 weeks"
16073827|NCT02354625|Biological|Autologous human Schwann cells|Schwann cells harvested from the sural nerve of the participant will be autologously transplanted into the epicenter of the participant's spinal cord injury.
16073828|NCT02354612|Drug|TRC105|
16073829|NCT02354612|Drug|Bevacizumab|companion therapy selection depends on companion therapy used in the parent study
16073830|NCT02354612|Drug|Axitinib|companion therapy selection depends on companion therapy used in the parent study
16073831|NCT02354612|Drug|Pazopanib|companion therapy selection depends on companion therapy used in the parent study
16073832|NCT02354612|Drug|Capecitabine|companion therapy selection depends on companion therapy used in the parent study
16073833|NCT02354599|Drug|MT203 80 mg or matching Placebo|MT203 80 mg or matching placebo injection
16073834|NCT02354599|Drug|MT203 150mg or matching Placebo|MT203 150mg or matching placebo injection
16073835|NCT02354599|Drug|MT203 300 mg or matching placebo|MT203 300 mg or matching placebo injection
16073837|NCT02354573|Drug|Ivabradine|All subjects will receive Ivabradine 7.5mg twice daily for 2 weeks in a double-blind randomized crossover design.
16073838|NCT02354560|Drug|Erythromycin|Oral Treatment with Erythromycin 250-500mg, twice daily, for 16 weeks.Exact dose is subjected to body weight and will be determined by the study's pediatrician.
16073839|NCT02354547|Genetic|SGT-53|The starting dose of SGT-53 will be 1.4 mg DNA/m² (dose level 1). If MTD is reached at dose level 1, subsequent cohort will be treated at 0.7 mg DNA/m² (dose level -1). If MTD is not reached at 2.1 mg DNA/m² (dose level 2), additional dose level(s) may be added. Intra-patient escalation is not allowed. Topotecan/cyclophosphamide will not be administered in cycle 1. In cycle 2, SGT-53 will be administered in combination with 0.6 mg/m² topotecan and 200 mg/m² cyclophosphamide IV daily for 5 days. Beginning in cycle 3, if no DLTs in cycle 2, topotecan and cyclophosphamide will be escalated to 0.75 mg/m² and 250 mg/m², respectively. No further dose escalation is permitted. If DLT develops at the higher doses, the doses should be decreased back to those in cycle 2.
16073840|NCT02354547|Drug|Topotecan|Topotecan/cyclophosphamide will not be administered in cycle 1. In cycle 2, 0.6 mg/m² topotecan will be administered in combination with SGT-53 and cyclophosphamide IV daily for 5 days. Beginning in cycle 3, if no DLTs in cycle 2, topotecan will be escalated to 0.75 mg/m². No further dose escalation is permitted. If DLT develops at the higher doses, the dose should be decreased back to those in cycle 2.
16073841|NCT02354547|Drug|Cyclophosphamide|Topotecan/cyclophosphamide will not be administered in cycle 1. In cycle 2, 200 mg/m² cyclophosphamide will be administered in combination with topotecan and SGT-53 IV daily for 5 days. Beginning in cycle 3, if no DLTs in cycle 2, cyclophosphamide will be escalated to 250 mg/m². No further dose escalation is permitted. If DLT develops at the higher doses, the dose should be decreased back to those in cycle 2.
16073842|NCT02354534|Drug|Artesunate Suppositories|
16073843|NCT02354521|Other|NO INTERVENTIONS|
16073844|NCT02354508|Drug|Pasireotide LAR|Pasireotide 40 mg and 60 mg. Pasireotide 20 mg which was allowed for dose decrease in case of adverse event.
16073845|NCT02354495|Dietary Supplement|Changes in energy and protein intake|Energy intake will be based on accurate measurements of energy expenditure. Protein intake will be matched to age-based recommended values if necessary.
16073846|NCT02354482|Behavioral|Patient Communication and Care Management|"Received the following Transitional Care strategies:
~Helpful Health Care Contact OR Symptom Management
~Post-discharge Care Consultation
~Patient Goal/Preference Assessment
~Plain Language Communication in Hospital
~Plain Language Communication at Home
~Transition Summary for Patients and Family Caregivers"
16073847|NCT02354482|Behavioral|Home-Based Trust, Plain Language, and Coordination|"Received the following Transitional Care Strategies:
~Transition Team
~Home visits
~Plain Language Communication at Home
~Promote Trust at Home
~Referral to Community Services
~Follow-up Appointment"
16073848|NCT02354482|Behavioral|Hospital-Based Trust, Plain Language, and Coordination|"Received the following Transitional Care Strategies:
~Post-discharge care consultation
~Identify High-Risk Patients and Intervene
~Medication Reconciliation
~Plain Language Communication in Hospital
~Promote Trust in the Hospital
~Transition Summary for Patients and Family Caregivers"
16073849|NCT02354482|Behavioral|Patient/Caregiver Assessment and Provider Information Exchange|"Received the following Transitional Care Strategies:
~Patient Goal/Preference Assessment
~Identify High-Risk Patients and Intervene
~Timely Exchange of Critical Patient Information among Providers
~Patient/Family Caregiver Transitional Care Needs Assessment"
16073850|NCT02354482|Behavioral|Assessment and Teach Back|"Received the following Transitional Care Strategies:
~Post-discharge care consultation
~Language Assessment
~Teach Back for Information and Skills"
16073851|NCT02354482|Other|Standard of Care (Reference)|No specific Transitional Care Strategy
16073852|NCT02354443|Biological|ProHema-CB Transplant|ProHema-CB, the cellular product, represents the cell populations contained within a human UCB unit after modulation on the day of transplantation by an ex vivo incubation process with the prostaglandin derivative, 16,16-dimethyl prostaglandin E2 (also referred to as FT1050). The cell populations include hematopoietic stem and progenitor cells.
16073853|NCT02354430|Behavioral|Water-exercise|"An instruction session at an indoor swimming pool, led by the research midwives and a specially trained coach. Participants is shown short movie clips of the six Aqua-Mama water-exercises and practical instructions by the coach while performing the exercises in water. The participants are encouraged to keep a training logbook during the project.
~One training session consists of: eight laps (200 m) of swimming and AquaMama exercises. Each exercise is illustrated on a board and are performed twice
~Unsupervised water-exercises (The six AquaMama exercises)
~Motivating weekly emails during the 12 week training period.
~Brush up sessions is held once every month for guidance in performing the exercises."
16073854|NCT02354417|Biological|Biological: ProHema-CB|Each subject will receive one administration of ProHema-CB unit transplant.
16073855|NCT02354404|Biological|cAd3-EBOZ|cAd3 vaccine vector expressing Ebola glycoprotein from the Zaire strain in single dose vials at 1x10(11) PU/mL.
16073856|NCT02354404|Biological|cAd3-EBO|1:1 ratio of cAd3 vaccine vectors expressing Ebola glycoprotein from the Zaire and Sudan strains filled into single dose vials at 1x10(11) PU/mL of each [2x10(11) PU/mL total].
16073857|NCT02354404|Biological|MVA-EbolaZ|MVA vaccine vector that expresses Ebola glycoprotein from the Zaire strain in single dose vials at 3.2 x 10(8) PFU/mL
16073858|NCT02354391|Drug|Ingenol mebutate Picato® and MAL PDT day 1, day 5|Treatment of ingenol mebutate, Picato® 0.015% topical gel applied on day 1 followed by MAL PDT on day 5
16073859|NCT02354391|Drug|Ingenol mebutate Picato® day 2, 3, 4|Full treatment course with Ingenol mebutate (Picato®) 0.015% topical gel, apply day 2,3 and 4
16073860|NCT02354391|Procedure|MAL PDT day 5|Methyl aminolevulate combined with Photodynamic therapy at day 5
16073861|NCT02354378|Drug|Dexmedetomidine|
16073862|NCT02354378|Other|Memory Test|
16073863|NCT02354365|Device|Transpulmonary Pressure measurement|Transpulmonary pressure measurements are done by placing a catheter (often combined with a feeding tube) into the esophagus of a patient. Intermittently, the esophageal pressure is measured by inflating a small balloon on this catheter. The resulting esophageal pressure is accepted as representing the pleural pressure. The difference between this pressure and the airway pressure is the transpulmonary pressure and PEEP is raised or lowered to make this value zero so that the forces distending the alveoli are just balanced with the natural elasticity of the lung which wants to collapse the alveoli.
16073864|NCT02354352|Drug|Eplerenone|26 Subjects will take Eplerenone, one 50mg capsule by mouth once daily for 12 months.
16073865|NCT02354352|Drug|Spironolactone|26 Subjects will take Spironolactone, one 50mg capsule by mouth once daily for 12 months.
16073866|NCT02354339|Dietary Supplement|Irvingia gabonensis|Intervention will be administered 30 minutes before meals
16073867|NCT02354339|Other|Placebo|Intervention will be administered 30 minutes before meals
16073868|NCT02354326|Radiation|virtual non-calcium dual-energy computed tomography|Undergo VNC DECT
16073869|NCT02354326|Radiation|computed tomography|Undergo CT without VNC
16073870|NCT02354313|Drug|Lenalidomide|"Treatment Phase: consisting in an induction phase (3 cycles of RCHOP, given every 21 days); consolidation phase: (high-dose cyclophosphamide (CTX), 2 cycles of high dose Ara-C, BEAM and ASCT).
~Randomization and maintenance phase: Patients who have achieved complete or partial response will be randomized between maintenance with lenalidomide or observation."
16073871|NCT02354300|Device|TCD Ultrasound|Transcranial doppler ultrasound monitoring will occur during flow diverter placement.
16073872|NCT02354287|Procedure|Cold forceps polypectomy with pre lift|"Polyps ≤7mm will be included in the study if deemed appropriate by the colonoscopist..
~These polyps will be resected with cold forceps after pre injection into the submucosa with a few millilitres of pre injection solution (19 ml gelofusine, 1ml 1:10000 adrenaline and 1ml indigo carmine). Polyps are grasped with the cold forceps and pulled away from the rest of the colonic mucosa. Attempt will be made to remove polyps with single attempt with the forceps however several grasps may be required for complete visual resection of the polyp.
~The polypectomy site and a 5mm rim of normal appearing tissue will then be resected with endomucosal resection (EMR) using conventional snare method. This is to ascertain if there is any residual polyp tissue."
16073873|NCT02354274|Radiation|Escalated: Inhomogeneous dose plan|
16073874|NCT02354274|Radiation|Standard: Homogeneous dose plan|
16073875|NCT02354261|Drug|SUBA-Itraconazole|Subjects will receive an oral dose of 300 mg SUBA-Itraconazole daily.
16073948|NCT02353689|Dietary Supplement|moderate FODMAP|consumed EN formula containing moderate FODMAPs (0.753g/can) during 14-day intervention
16073949|NCT02353689|Dietary Supplement|high FODMAP|consumed EN formula containing high FODMAPs (1.222g/can) during 14-day intervention
16073876|NCT02354248|Procedure|Triple stimulation technique|Evoked motor potentials obtained by magnetic transcranial stimulation are usually used, in standard practice, to evaluate the corticospinal tract. This procedure combines two techniques: the magnetic stimulation and the electroneuromyography. It is based on the double collision principle between the descending central stimulation (magnetic) and the ascending peripheric stimulation, hereby suppressing the issue of desynchronisation of evoked motor potentials. The Triple stimulation technique allows a better quantification of the proportion of motor units activated by the transcranial stimulation.
16073877|NCT02354235|Drug|Teneligliptin|
16073878|NCT02354235|Drug|Canagliflozin|
16073879|NCT02354235|Drug|Placebo|
16073880|NCT02354222|Drug|Canagliflozin|
16073881|NCT02354222|Drug|Teneligliptin|
16073882|NCT02354222|Drug|Placebo|
16073883|NCT02354196|Procedure|CCTA|CT of heart to assess coronary disease
16073884|NCT02354183|Behavioral|DBT Skills Training|Based on Linehan's (1993) manualized DBT approach, the brief DBT skills training group covers will cover five skills: wise mind, TIP skills, distraction, mindfulness of the current emotion, and opposite to emotion action.
16073885|NCT02354170|Drug|Mifepristone|
16073886|NCT02354170|Drug|Placebo|
16073887|NCT02354157|Other|no intervention|no intervention
16073888|NCT02354144|Other|Carrageenan-based gel|Carrageenan is a non-toxic gelling agent safe in animals and humans as a potent HPV inhibitor. An anionic polymer derived from red algae, carrageenan has a long history of human use as a stabilizer and emulsifier in many industries. All three major classes of carrageenan act as extremely potent HPV inhibitors and block HPV infection by binding to the viral capsid, thus preventing attachment to the appropriate cell-surface heparan sulfate proteoglycans (HSPG) receptors.
16073889|NCT02354144|Other|Control gel|A gel not containing carrageenan
16073890|NCT02354131|Drug|Niraparib|Niraparib versus Bevacizumab-Niraparib combo
16073891|NCT02354131|Drug|Bevacizumab|
16073892|NCT02354118|Other|Heparinized saline catheter flush|The control group will have their port catheters flushed with 20mL saline + 5mL heparin 100 units/mL; q 3 months
16073893|NCT02354118|Other|Saline-only catheter flush|The intervention group will have their port catheters flushed with saline only.
16073894|NCT02354092|Procedure|Local anesthetic for tenaculum placement|2 mL of buffered Lidocaine injected superficially at anterior lip of cervix in 12 o'clock position Drug: 1% Lidocaine Hydrochloride, 8.4% Sodium Bicarbonate
16073895|NCT02354092|Procedure|Sham|Over 60 seconds, without moving the tenaculum, a capped needle gently touches the vaginal sidewall at the level of the external os at 4 and 8 o'clock positions
16073896|NCT02354092|Procedure|Paracervical Block|18 mL of buffered Lidocaine is slowly injected into the vaginal fornices and equally distributed at 4 and 8 o'clock. The injection is continuous from superficial to deep (3cm) to superficial (injecting with insertion and withdrawal) Drug: 1% Lidocaine Hydrochloride, 8.4% Sodium Bicarbonate
16073897|NCT02354092|Procedure|Dilator Placement|"Osmotic dilators will be placed in the usual fashion with a combination of Dilapan-S and laminaria per clinician preference
~Drugs:
~Dilapan-S is a hygroscopic cervical dilator made of a patented hydrogel called AQUACRYL. It is a rigid hydrophilic stick that increases in volume by absorbing fluids and comfortably dilating the cervix.
~Laminaria is an herbal medicine used to induce labor and abortion. The dried stem of Laminaria mechanically dilates the cervical opening by absorbing water and swelling to several times its original diameter."
16073898|NCT02354092|Behavioral|Post-procedural assessment|15 minutes after procedure, subjects will complete a questionnaire that collects information about pain, negative symptoms, and assessment of how effective their pain management was.
16073899|NCT02354092|Drug|Preprocedural pain control|800 mg Ibuprofen taken before dilator placement
16073900|NCT02354079|Genetic|hypobetalipoproteinemia genetic and genotypic screening|
16073901|NCT02354066|Device|Hallux valgus Shoe|Brake response measurement after surgery with this foot orthosis
16073902|NCT02354066|Device|Forefoot relief shoe|Brake response measurement after surgery with this foot orthosis
16073903|NCT02354066|Device|Retail Shoe|Brake response time measurement before surgery (control run)
16073904|NCT02354053|Drug|Switch to Triumeq|
16073905|NCT02354053|Behavioral|Adherence support + current ART|
16073906|NCT02354040|Behavioral|Talking Rx|For patients in the intervention group, the physician written prescription for anti-platelet and statin will be transferred on an OMR sheet and will be scanned. The information on the prescription (dose, name of the medication, duration, route or any other special instruction) will be sent to the patients via a text and a voice SMS (in Urdu language). The patients also receive an individualized code that helps them request for repeated reminders for their medication timings. However, a weekly medication reminder SMS will be sent to the patients in the intervention arm.
16073907|NCT02354027|Drug|SHR3824 metformin|"Two 500-mg tablets of metformin on Day 1 followed by 25 mg of SHR3824 once daily on Days 4 through 8 followed by two 500-mg tablets of metformin and 25 mg of SHR3824 on Day 8.
~Drug: SHR3824 + Metformin"
16073910|NCT02354001|Drug|Raloxifene hydrochloride|120mg daily- 1 capsule for 12 week trial
16073911|NCT02354001|Drug|Placebo|1 capsule daily for 12 week trial - lactose
16073950|NCT02353676|Drug|Bupivacaine|1.5 ml of 0.55 bupivacaine solution to be used as postoperative anesthetic agent for prolonged analgesia
16075047|NCT02345746|Drug|Folinic Acid|as a 2-hour infusion via HAI on day 2
16073912|NCT02353988|Drug|Bicalutamide|"Patients in experimental group are designated to take bicalutamide orally, 150mg on a continuous schedule. The investigator should pay attention to the patients' adverse event. Every month, the patients will be evaluated for the adverse event by the criterion National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 3.0. Every 2 months, the patients will be evaluated for the clinical effects. If disease progressed, the patients would be ruled out.
~Treatment continued until disease progression, unacceptable toxic effects, patient or physician request to discontinue, or serious protocol non-compliance. A maximum of 2 dose reductions for grade >= 3 toxicity were allowed (100 and 50 mg). A maximum of 2 weeks was permitted for treatment delays due to toxicity."
16073913|NCT02353988|Other|Physician's Choice|"The comparator group, treatment of physician's choice (TPC), represented a mix of agents (both approved and non-approved for metastatic breast cancer) to mirror clinical practice at the time in this setting.
~The 60 patients are enrolled in the study, before randomized to the two arms, each of them will be assessed for eligibility and then their proposed TPC.
~Treatment continued until disease progression, unacceptable toxic effects, patient or physician request to discontinue, or serious protocol non-compliance."
16073914|NCT02353975|Drug|SHR3824|SHR3824 tablet,10mg, fasting conditions and high fat, high calorie breakfast.
16073915|NCT02353962|Other|Neglect Exergames|Exergames for rehabilitation of hemineglected stroke patients played with a haptic device on a computer. The intervention duration is three weeks. During this week the patients play daily a half hour on workdays. The treatening therapist will adjust the intensity according to the progress of the patient.
16073916|NCT02353949|Drug|Flutemetamol (Vizamyl)|PET-MR Scan using the radiotracer Flutemetamol (Vizamyl) for diagnostic purpose
16073917|NCT02353936|Drug|BIBW2992|"International Nonproprietary Name (INN): BIBW 2992 Pharmacological dosage form: Film-coated tablet Supplier: Boehringer Ingelheim Pharma GmbH & Co. KG Unit content: 40 mg, 30 mg, 20 mg film-coated tablet (BIBW 2992 content in film-coated tablet is related with equivalent free base BIBW 2992.) Daily dose: 40 mg Dosing period: To be successively administered once daily until a disease will develop, an unacceptable adverse event will occur, or another reason requiring discontinuation of the study will occur; For administration, study treatment consists of periods(each 4 weeks(28 days)).
~Route of administration: Orally (Take by swallowing) Dosage: Once daily"
16073918|NCT02353923|Dietary Supplement|OcuStem Supplementation|2800 mg daily dosage of OcuStem, 2 capsules BID.
16073919|NCT02353910|Procedure|Ultrasound|
16073920|NCT02353871|Biological|Botulinum toxin type A|A solution containing 50 U in 0.25 mL (200 U/mL). Each vial contained 0.625 mL of deliverable volume of solution. A volume of 0.25 mL, containing 50 U of BTX-A-HAC NG (i.e. 10 U/0.05 mL) was withdrawn from the vial into a syringe for administration. The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection), each of which was to be administered into predefined sites across the glabellar region (two injections into each corrugator muscle and one injection into the procerus muscle).
16073921|NCT02353871|Drug|Placebo|A solution containing only the excipients of BTX-A-HAC NG (identical in appearance to the active product). Each vial contained 0.625 mL of deliverable volume of solution. A volume of 0.25 mL was withdrawn from the vial into a syringe for administration. The total treatment volume (0.25 mL) was divided into five injections (0.05 mL per injection), each of which was to be administered into predefined sites across the glabellar region (two injections into each corrugator muscle and one injection into the procerus muscle).
16073922|NCT02353858|Other|Deep regional hyperthermia|Deep regional hyperthermia of the pelvis, Total time 90 min, Target temperature 41-42°C.
16073923|NCT02353858|Radiation|Radiotherapy|Radiotherapy of the primary tumor and pelvis, 5 x 1,8 Gy per week, total Dose: 50,4 Gy.
16073924|NCT02353858|Drug|Chemotherapy (5-Fluorouracil)|5-Fluorouracil, continuous venous infusion week 1 and 5. 1000 mg per square meter of body-surface area per day.
16073925|NCT02353832|Device|Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent)|Injectable Rectal Spacer (SpaceOAR, Duraseal or equivalent PEG based product
16073926|NCT02353819|Radiation|Stereotactic Ablative Radiotherapy|SABR x5 fractions CBCT based image-guidance prior to each fraction: localize based on prostate/seeds positions SCORE system
16073927|NCT02353806|Drug|Amlodipine besylate|Pregnant and postpartum women will continue taking amlodipine besylate 5 mg for treatment of chronic hypertension as prescribed by their clinician.
16073928|NCT02353793|Device|ReadyHeat® blanket|Using ReadyHeat® blanket for patient warming
16073929|NCT02353793|Device|Cotton wool blanket|Using cotton wool blanket for patient warming
16073930|NCT02353780|Drug|TNF Antagonist (enbrel, humire, remicade, cimzia, symponi)|TNF Antagonist; treating rheumatologist selects specifics for the therapy chosen.
16073931|NCT02353780|Drug|Abatacept|Abatacept; SQ; specifics to be determined by the treating rheumatologist.
16073932|NCT02353780|Drug|Tocilizumab|Tocilizumab; SQ; specifics determined by the treating rheumatologist.
16073933|NCT02353767|Procedure|Noninvasive evaluation of liver fibrosis and steatosis|Transient elastography (using the Fibroscan, CAP Fibroscan) and biomarker panels (FibroTest, Fibromètre, Hepascore, Steatotest, Nashtest)
16073934|NCT02353754|Drug|Intrathecal morphine injection|0.2 mg
16073935|NCT02353754|Drug|EXPAREL|266 mg
16073936|NCT02353741|Drug|EGFR-TKIs|Beginning on day 2 of treatment, receive oral erlotinib 150mg per day.
16073937|NCT02353741|Radiation|thoracic radiotherapy|From the beginning of EGFR-TKIs, within 2 weeks, receive concurrent thoracic radiotherapy, pGTV54～60Gy/27～30f/5.5～6w.
16073938|NCT02353728|Drug|Nilotinib|
16073939|NCT02353715|Drug|Enzalutamide|
16073940|NCT02353715|Drug|Abiraterone acetate|
16073941|NCT02353715|Drug|Sipuleucel-T|
16073942|NCT02353702|Procedure|Sniff test|Evaluation of diaphragmatic function by sniff test after continuous parietal infusion of ropivacaine or placebo
16073943|NCT02353702|Drug|Infusion of Ropivacaine during 48 hours|"20 ml Bolus (7,5 mg/ml) then continuous administration of 10 ml per hour (2 mg/ml) during 48 hours of Ropivacaine.
~20 ml Bolus (NaCl 0.9 %) then continuous administration of 10 ml per hour, during 48 hours of NaCl 0.9 %."
16073944|NCT02353702|Device|Continuous parietal infusion with parietal catheter|Continuous parietal infiltration of Ropivacaine or placebo
16073945|NCT02353702|Drug|Infusion of placebo during 48 hours|
16073946|NCT02353702|Drug|NaCl|
16073947|NCT02353689|Dietary Supplement|low FODMAP|consumed EN formula containing low FODMAPs (0.320g/can) during 14-day intervention
16073951|NCT02353676|Other|SALINE|1.5 ml of placebo (saline solution) to be injected into the opposite site postoperatively.
16073952|NCT02353663|Other|Echocardiography|Echocardiography examination
16073953|NCT02353650|Dietary Supplement|Q10|
16073954|NCT02353650|Dietary Supplement|placebo|
16073955|NCT02353637|Dietary Supplement|Partial Meal Replacements|The use of partial meal replacements will be utilized in conjunction with a high protein, restricted carbohydrate diet
16073956|NCT02353624|Behavioral|Cycling|Cycling distance of 2880 km in 14 days
16073957|NCT02353611|Other|6% hydrogen peroxide|
16073958|NCT02353611|Other|35% hydrogen peroxide|conventional peroxide whitening compound acted like control
16073959|NCT02353598|Drug|Crenezumab dose level 1|Participants will receive crenezumb dose level 1 IV infusion once every 4 weeks up to Week 13 in double-blind treatment window or up to Week 61 in optional OLE window.
16073960|NCT02353598|Drug|Crenezumab dose level 2|Participants will receive crenezumb dose level 2 IV infusion once every 4 weeks up to Week 13 in double-blind treatment window or up to Week 61 in optional OLE window.
16073961|NCT02353598|Drug|Crenezumb dose level 3|Participants will receive crenezumb dose level 3 IV infusion once every 4 weeks upto Week 13 in double-blind treatment window or up to Week 61 in optional OLE window.
16073962|NCT02353598|Drug|Placebo|Participants will receive placebo matched to crenezumab IV infusion once every 4 weeks upto Week 13 in double-blind treatment window.
16073963|NCT02353572|Drug|Melphalan|Given IV
16073964|NCT02353572|Drug|Bortezomib|Given IV
16073965|NCT02353572|Drug|Dexamethasone|Given IV
16073966|NCT02353572|Procedure|Autologous Transplant|Undergo autologous hematopoietic stem cell transplant
16073967|NCT02353559|Behavioral|EASE|EASE includes psychotherapeutic (EASE-psy) and physical symptom control (EASE-phys) components.
16073968|NCT02353546|Behavioral|CALM|
16073969|NCT02353533|Device|over- the- scope full- thickness resection device (FTRD)|Endoscopic resection of adenomatous lesions of the colon using the over- the- scope full- thickness resection device
16073970|NCT02353533|Device|EMR|Standard endoscopic mucosal resection using a resection snare
16073971|NCT02353520|Other|motricity index strength assessment|
16073972|NCT02353507|Device|Opticell Ag+|
16073973|NCT02353507|Device|Aquacel Ag+|
16073974|NCT02353494|Drug|Dihydroartemisinin-Piperaquine|Treatment according to national guidelines with follow up.
16073975|NCT02353481|Other|Heart Failure Management|
16073976|NCT02353468|Drug|Bortezomib|Given IV
16073977|NCT02353468|Drug|Lenalidomide|Given PO
16073978|NCT02353468|Drug|Dexamethasone|Given PO or IV
16073979|NCT02353455|Procedure|Blood sampling|In each group a blood sample of approximately 50 mL will be obtained upon study inclusion.
16073980|NCT02353442|Other|Posterior shoulder mobilizations|A second investigator performed 5min of posterior capsule shoulder mobilization for the experimental group, 3times/week during 4 weeks.
16073981|NCT02353442|Other|External rotators strengthening|Individuals performed 3x10 repetitions of external rotators strengthening in sidelying position 3times/week during 4 weeks.
16073982|NCT02353442|Other|Placebo ultrasound|A second investigator performed 5min of placebo ultrassound for the control group, 3times/week during 4 weeks.
16073983|NCT02353442|Other|Scapular squeezing|Individuals performed 3x10 repetitions scapular squeezing exercise 3times/week during 4 weeks.
16073984|NCT02353442|Other|Upper trapezius stretching|Individuals performed 3x30s of upper trapezius stretching, 3times/week during 4 weeks.
16073985|NCT02353442|Other|Posterior Capsule Stretching|Individuals performed 3x30s of posterior capsule stretching, 3times/week during 4 weeks.
16073986|NCT02353429|Drug|Toremifene|Patients will receive 60 mg daily and then 180 daily in case of progression
16073987|NCT02353416|Behavioral|Low Glycemic Index Mediterranean Diet|Prescription of a Low Glycemic Index (less than 50) Mediterranean Diet with no more than 10% of total daily calories coming from saturated fats, high in monounsaturated fatty acids (MUFA) from olive oil and omega-3 polyunsaturated fatty acids (ω3PUFA), from both plant and marine sources
16073988|NCT02353416|Other|INRAM Guidelines' diet|Prescription of INRAM guidelines' diet
16073989|NCT02353403|Other|Sugar|A 210g chocolate dairy dessert made with 35g of dextrose.
16073990|NCT02353403|Other|FOS|A 210g chocolate dairy dessert made with 24g of dextrose and 11.2g of FOS.
16073991|NCT02353390|Other|Oral Water Hydration|Subjects in the hydration group will be allowed up to 15 minutes to drink up to 500 milliliters (mL) of water prior to the vaccines. Subjects will be encouraged to drink the entire 500 mL; however, they are free to drink as much as they want and can finish before the end of the 15-minute period. Subjects will be instructed not to share the water and to not otherwise empty the bottle. As with the control group, subjects will be instructed not to eat or drink anything else for the duration of the study, unless clinically indicated (e.g., as part of management of presyncope or syncope).
16073992|NCT02353364|Other|PGS|Embryos screened by the validated NGS technology CNV-Seq
16073993|NCT02353351|Device|atrial septal occluder|Single arm atrial septal defect closure with the AMPLATZER Septal Occluder
16073994|NCT02353338|Procedure|Surgical intervention|Surgical management of radial fracture
16073995|NCT02353338|Procedure|Conservative management|Immobilized/cast for 6 weeks
16073996|NCT02353338|Device|cast|
16073997|NCT02353325|Dietary Supplement|non-encapsulated FeSO4|
16073998|NCT02353325|Dietary Supplement|encapsulated FeSO4, before cooking|
16073999|NCT02353325|Dietary Supplement|encapsulated FeSO4, after cooking|
16074000|NCT02353325|Dietary Supplement|non-encapsulated FeSO4 + ascorbic acid|
16074001|NCT02353325|Dietary Supplement|encapsulated FeSO4 + ascorbic acid, before cooking|
16074002|NCT02353325|Dietary Supplement|encapsulated FeSO4 + ascorbic acid, after cooking|
16074003|NCT02353312|Drug|Kuvan|Kuvan® (sapropterin dihydrochloride) will be initiated at 10mg/kg/day with meals for one week. After telephone contact on day 7, assuming no adverse effects are noted, the patient will be instructed to increase their daily dose to 20mg/kg/day with meals for the remainder of the 3 months.
16074004|NCT02353299|Drug|Silenor 6 mg|Silenor 6 mg single nighttime dose.
16074005|NCT02353299|Drug|zolpidem 10 mg|Zolpidem 10 mg single nighttime dose
16074006|NCT02353299|Drug|Placebo|placebo single nighttime dose-1.5 hours
16074008|NCT02353286|Device|Endoscopic insertion of biodegradable biliary stent|Endoscopic insertion of biodegradable biliary stent
16074009|NCT02353273|Drug|WH-1 ointment|Each subject will be applied the one dose of WH-1 ointment on Day 1, and twice a day of WH-1 application from Day 2 to Day 13, then one dose for Day 14.
16074010|NCT02353260|Device|Ultrasound Hyperthermia|treated with Therapeutic Ultrasound device on the 1st,3rd,5th,7th,9th day of each 21 day cycle
16074011|NCT02353260|Drug|Docetaxel,Cisplatin,Fluorouracil|Squamous cell carcinoma of head and neck: Docetaxel(75mg/m²,d1/21d,2 cycles);Cisplatin(75mg/m²,d1/21d,2 cycles);Fluorouracil(750mg/m²/d,d1-5/21d, 2 cycles)
16074012|NCT02353247|Drug|Norethindrone acetate|
16074013|NCT02353234|Other|Bread|In each arm subjects consume bread
16074014|NCT02353208|Other|Sham Feeding of Bacon Bits|Bacon bits will be a commercially available produce which has been deemed safe for sale in Canada.
16074015|NCT02353208|Other|Placebo|Participants will not be asked to chew bacon bits
16074016|NCT02353195|Other|Radiofrequency|The equipment used, 35-mm diameter CAP and 30-mm diameter RES movable electrode was used on the affected site, and a planar electrode was used as a return electrode on the abdomen. The electricity was administered in the following manner: cream was applied to the site with the severest pain and its adjacent area, and the electrical output was increased by moving the movable electrode within the patient´s tolerance level, while monitoring the skin temperature tolerable to the patient.
16074017|NCT02353182|Drug|Dexmedetomidine|Loading dose:1 mcg/kg over 10 minutes. Infusion: Start 1-1.5 mcg/kg/hr. Titrate up or down within 50% of starting doses as needed.
16074018|NCT02353182|Drug|Remifentanil|Loading dose: 1 mcg/kg over 1-2 minutes. Infusion: Start at 0.2-0.5 mcg/kg/min. Titrate up or down (max 0.5 mcg/kg/min) as needed.
16074019|NCT02353182|Drug|Bupivacaine|Administered in caudal/epidural/field block: 0.175%-0.25% (dose at discretion of anaesthetist)
16074020|NCT02353182|Drug|Ropivacaine|Administered in caudal/epidural/field block: 0.2% (dose at discretion of anaesthetist)
16074021|NCT02353169|Drug|Dexmedetomidine|
16074022|NCT02353169|Drug|Saline|
16074023|NCT02353156|Other|Electronic bidet|electronic bidet after hemorrhoidectomy for relieving pain and inducing wound healing
16074024|NCT02353156|Other|Sitz bath|sitz bath after hemorrhoidectomy for relieving pain and inducing wound healing
16074025|NCT02353143|Drug|MEN1112|"Intravenous infusion of MEN1112 pro/Kg body weight dose will be administered for two 21-day cycles; MEN1112 dose is administered as' one shot infusion' (first group of patients) and as a dose to be infused in 3 days for the first two doses in Cycle 1 (second group of patients).
~Two treatment cycles will be followed by a 4-week End of Treatment Period and a Follow-up period. The individual treatment/observation period is six months (except for female patients of childbearing potential that will undergo monthly pregnancy test until 6 months from the last study drug administration)."
16074026|NCT02353130|Drug|Memantine-XR|Participants will begin with 7mg Memantine XR® daily for a minimum of one week before increasing to an optimal dose of 14 mg daily. It is suggested that participants be titrated to the optimal dose by week 2 so that they may remain on 14mg for at least 6 weeks. Morning dosing is suggested, but can be flexible.
16074027|NCT02353117|Behavioral|Congenital Syphilis Intervention Group|
16074028|NCT02353104|Dietary Supplement|Onion-Pumpkin Extract|
16074029|NCT02353091|Device|Remote Microphone Hearing Aids|The ear receivers connect wirelessly with the microphone being worn by the teacher within a range of 25m.
16074030|NCT02353078|Drug|Sucralfate|Sucralfate slurry 1 gram four times daily for four weeks
16074031|NCT02353078|Procedure|Intraluminal Impedance|During the initial endoscopy, esophageal mucosal impedance will also be measured. This procedure involves passing a mucosal impedance probe through the endoscope and gently placing the tip of the probe on the esophageal mucosa. Measurements will be made at 2,5,10 and 15 cm above the gastroesophageal junction. There is no increased risk to the procedure and it adds approximately 2 minutes to the procedure.
16074032|NCT02353078|Device|Intraluminal Impedance|The mucosal impedance probe is a 2.13 mm catheter (tiny tube), called an Intraluminal Impedance, will be passed through the channel of the standard endoscope. There is no increased risk to the procedure and it adds approximately 2 minutes to the procedure.
16074033|NCT02353065|Procedure|Ultrasound imaging|Point of care ultrasound of fracture site during and post-reduction
16074034|NCT02353065|Radiation|Bedside x-ray|Portable x-ray of fracture post-reduction
16074035|NCT02353052|Other|follow up|The patients were followed up for 3 years about their survival conditions and tumor status (eg. recurrence and metastasis).
16074036|NCT02353039|Drug|GC6101A 37.5mg|Administer 12.5mg of GC6101A t.i.d for 2 weeks.
16074037|NCT02353039|Drug|GC6101A 75mg|Administer 25mg of GC6101A t.i.d for 2 weeks.
16074038|NCT02353039|Drug|GC6101A 150mg|Administer 50mg of GC6101A t.i.d for 2 weeks.
16074039|NCT02353039|Drug|Placebo|Administer placebo t.i.d for 2 weeks
16074040|NCT02353026|Drug|Intravenous Artesunate|Intravenous Artesunate in escalating doses: 8, 12, 18, 25, 34, 45 mg/kg on days 1 and 8 of every 3 week cycles
16074041|NCT02353013|Dietary Supplement|Protein supplementation|Standard fortification of human milk may not have enough protein for optimal growth of premature infants. The investigators will add extra protein to this group to increase the protein consumed.
16074042|NCT02353013|Dietary Supplement|Standard fortification|Standard fortification of human milk involves adding a commercially available human milk fortifier to human milk in order to increase several nutrients.
16074043|NCT02353000|Radiation|Stereotactic Radiosurgery|Stereotactic Radiosurgery for patients with 4 up to 10 brain metastases
16074044|NCT02353000|Radiation|Whole Brain Radiotherapy|Whole Brain Radiotherapy for patients with 4 up to 10 brain metastases
16074045|NCT02352987|Drug|Neem plus propylene glycol plus salicylic acid|Leaf extract of neem plus propylene glycol (40%) plus salicylic acid (10%) will be applied on palmar keratotic lesion once daily at bedtime for 12 weeks
16074046|NCT02352987|Drug|Salicylic acid|salicylic acid (10%) will be applied on palmar keratotic lesion once daily at bedtime for 12 weeks
16074047|NCT02352974|Drug|GAD-Alum|
16074048|NCT02352974|Drug|Vitamin D|
16074049|NCT02352961|Other|Exclusive Intervention Strategy|"The Exclusive Intervention Strategy aimed at men aged 25 - 49 years and Active Follow-up strategy"
16074050|NCT02352948|Drug|MEDI4736 (durvalumab)|MEDI4736 (durvalumab) treatment by intravenous infusion
16074051|NCT02352948|Drug|Vinorelbine|Vinorelbine by intravenous infusion. Administered at a dose of 30 mg/m2 iv on Days 1, 8, 15 and 22 of a 28-day cycle.
16074052|NCT02352948|Drug|Gemcitabine|Gemcitabine by intravenous infusion. Administered at a dose of 1000 mg/m2 iv over 30 minutes on Days 1, 8, and 15 of a 28-day cycle.
16074053|NCT02352948|Drug|Erlotinib|Erlotinib administered at a dose of 150 mg once daily as a tablet for oral administration
16074054|NCT02352948|Drug|MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4)|MEDI4736 (durvalumab) in combination with tremelimumab (anti-CTLA4) treatment by intravenous infusion
16074055|NCT02352948|Drug|tremelimumab (anti-CTLA4)|tremelimumab (anti-CTLA4) treatment by intravenous infusion
16074056|NCT02352935|Device|NanoKnife LEDC System|90 pulses of 70 microseconds each in duration will be administered per electrode pair
16074057|NCT02352922|Drug|Liposomal Bupivacaine|pre-incision infiltration with liposomal bupivacaine
16074058|NCT02352922|Drug|Bupivacaine HCl|pre-incision infiltration with bupivacaine HCl
16074059|NCT02352909|Other|Education|Education on running training modifications depending on symptoms (decrease running speed, spread running volume throughout the week, run/walk intervals, avoid downhill and stairs running). Education about symptoms will also be provided.
16074060|NCT02352909|Other|Exercise program|A home-based program including strengthening and motor control exercises will be prescribed. The program will include 4 different phases of 2 weeks.
16074061|NCT02352909|Other|Gait retraining|Running gait will be modified to reduce knee loading while running (step frequency, impact, foot strike pattern).
16074063|NCT02352883|Procedure|Magnetic Resonance Imaging|Undergo MRI
16074064|NCT02352883|Procedure|Therapeutic Conventional Surgery|Undergo mastectomy
16074065|NCT02352883|Procedure|Therapeutic Surgical Procedure|Undergo wide local excision
16074066|NCT02352883|Radiation|Radiation Therapy|Undergo radiation therapy
16074067|NCT02352883|Drug|Endocrine Therapy|Undergo endocrine therapy
16074068|NCT02352883|Other|Quality-of-Life Assessment|Ancillary studies
16074069|NCT02352883|Other|Laboratory Biomarker Analysis|Correlative studies
16074070|NCT02352883|Other|Cytology Specimen Collection Procedure|Correlative studies
16074071|NCT02352870|Behavioral|Computerised Cognitive Behavioural Therapy|Online treatment sessions are scheduled to last approximately one hour, completed independently by the participant on a weekly basis
16074072|NCT02352870|Behavioral|Telephone support|Telephone support calls are scheduled to last 30 minutes and and are received fortnightly at weeks: 2, 4 and 6.
16074073|NCT02352857|Other|Sugar|100g of sponge cakes made with 24g of dextrose.
16074074|NCT02352857|Other|FOS|100g of sponge cakes made with 19.4g of dextrose and 9.1g of FOS.
16074075|NCT02352844|Drug|Everolimus|
16074076|NCT02352831|Drug|Tosedostat|
16074077|NCT02352831|Drug|Capecitabine|
16074078|NCT02352831|Procedure|Fresh tissue biopsy|Patients who have a partial response at the end of cycle 2 will be required to undergo biopsy if deemed safe for the patient and tissue is feasible to obtain.
16074079|NCT02352818|Other|no study intervention|
16074080|NCT02352805|Device|ECLS/ECC|Extracorporeal circulation and mechanical circulatory support for heart or lung or renal failure during intensive care therapy or cardiac surgery
16074081|NCT02352792|Radiation|radiochemotherapy with 70 Gy|
16074082|NCT02352792|Radiation|radiochemotherapy with 77 Gy|
16074083|NCT02352779|Dietary Supplement|Omega-3 Fatty Acid|Given PO
16074084|NCT02352779|Other|Placebo|Given PO
16074085|NCT02352779|Other|Questionnaire Administration|Ancillary studies
16074086|NCT02352779|Other|Laboratory Biomarker Analysis|Correlative studies
16074087|NCT02352753|Drug|Denosumab|All subjects who remain on-study (have not previously completed Month 36/End of Study (EOS) under the 6-Month Dosing Regimen) will be eligible to transition to the 3-Month Dosing Regimen.Approximately 150 subjects will be enrolled. Approximately 120 subjects will transition to the 3-Month Dosing Regimen. No additional subjects will be enrolled into this study. All subjects will receive denosumab 1 mg/kg (up to a maximum of 60 mg) subcutaneously every 3 months for a minimum of 12 months, and all subjects will receive appropriate calcium and vitamin D.
16074088|NCT02352740|Dietary Supplement|A form Arginine|3 capsules containing 0.5g of A form of L-arginine (1.5g) 3 times daily (4.5g per day) for 1 week
16074089|NCT02352740|Dietary Supplement|B form Arginine|3 capsules containing 0.5g of B form of L-arginine (1.5g) 3 times daily (4.5g per day) for 1 week
16074090|NCT02352714|Drug|Paracervical Nerve Block|Block randomization to receive lidocaine paracervical nerve block vs sham cervical block
16074091|NCT02352714|Drug|Sham Paracervical Block|Block randomization to receive lidocaine paracervical nerve block vs sham cervical block
16074092|NCT02352701|Drug|Noltec tab. 10mg|Ilaprazole 10mg BID dosage form : delayed release tablet
16074093|NCT02352701|Drug|Chongkundang Amoxicillin Cap. 500mg|Amoxicillin 1000mg, BID dosage form : capsule
16074094|NCT02352701|Drug|Cravit Tab. 500mg|Levofloxacin 500mg, BID dosage form : film coated tablet
16074095|NCT02352688|Procedure|Enhanced Colorectal Geriatric Care|
16074096|NCT02352675|Other|Intraoperative Blood Sample|Blood sample will be run using rotational thromboelastometry to determine the minimal concentration of TXA and EACA need to inhibit fibrinolysis
16074097|NCT02352662|Other|Perioperative blood samples collection|Collect blood samples at 3 different points intra-operatively. Each blood sample will be run using rotational thromboelastometry to assess intraoperative coagulation
16074098|NCT02352649|Drug|Neovasculgen|
16074099|NCT02352636|Other|magnetotherapy|The magnetic pellets will contain an average of ~200 gauss/pellet magnetic flux densities, with a diameter of 1.76 mm
16074100|NCT02352636|Device|laser auriculotherapy|A laser device (pointer pulse) will be used in this study. This device has a wavelength of 650 nm, an average output power of 2.5 mW, energy density of 1 minute with 0.54 J/cm2, and a pulse of 10 Hz, which is a common acceptable dosage for clinical use. This application belongs to a low-energy laser therapy (LLLT), in which the energy level emitted from the device is approximately comparable to a teaching pointer.
16074167|NCT02352168|Drug|Budesonide nasal spray|64mcg/1putt, 1 putt/nostril,b.i.d
16074168|NCT02352168|Drug|Placebo|1 putt/nostril,b.i.d
16074101|NCT02352636|Other|Placebo|"Subjects will serve as a placebo control, and will receive LAT at power off mode (i.e. deactivated laser) for acupoint stimulation before the application of plaster without magnetic pellets that mimic MAT treatment."
16074102|NCT02352623|Radiation|DXA scan|DXA scan
16074103|NCT02352623|Procedure|Clinical examination|Clinical examination
16074104|NCT02352610|Procedure|LRTI|
16074105|NCT02352610|Device|Biotenodesis Screw|
16074106|NCT02352597|Drug|phytoestrogen|20mg of cimifuga racemosa from day 1- 12
16074107|NCT02352597|Drug|estradiol valerate|2mg from cycle day 7 to day 11
16074108|NCT02352597|Drug|clomiphene citrate|50 mg orally every 8 hours started from cycle day 3 for 5 days
16074109|NCT02352584|Biological|GC3110A(Quadrivalent)|GC3110A(Quadrivalent), 0.5ml, intramuscular, a single dosing at Day 1
16074110|NCT02352584|Biological|GC Flu(Trivalent)|GC Flu Pre-filled Syringe Inj.(Trivalent), 0.5ml, intramuscular, a single dosing at Day 1
16074111|NCT02352584|Biological|GC3110A(Trivalent)|GC3110A(Trivalent), 0.5ml, intramuscular, a single dosing at Day 1
16074112|NCT02352571|Biological|GC1118|"For Part A, GC1118 will be administered by IV infusion once per week for 4 weeks (28-day cycles) in the dose escalation cohorts, starting 0.3mg/kg until Maximum Tolerated Dose is defined.
~For Part B, the defined MTD/RP2D of GC1118 will be administered by IV infusion once per week for 4 weeks (28-day cycles) in patients with stage IV of gastric cancer, colorectal cancer or other cancers.
~For Part C, GC1118 will be administered by IV infusion once every 2 weeks for 4 weeks (28-day cycles) in patients with all stage IV advanced solid cancers.
~Part A, Part B and Part C participants who qualify for subsequent cycles will receive continued GC1118 until evidence of progression of disease."
16074113|NCT02352558|Drug|BBI608|Patients will receive BBI608 orally twice daily, with doses separated by approximately 12 hours. The starting dose for all cohorts will be 240 mg twice daily. Subsequently, cohorts at alternate dose-levels (480 mg twice daily) may be enrolled as determined by the criteria for dose-escalation.
16074114|NCT02352558|Drug|Dexamethasone|Dexamethasone will be taken orally at a dose level of 40 mg once weekly, on Days 1, 8, 15, and 22 of each Cycle. Patients over the age of 75 years are allowed to begin dexamethasone at a dose of 20 mg once weekly, on Days 1, 8, 15, and 22 of each Cycle. Dexamethasone should be taken with food or milk, and a minimum of 2 hours should separate a dose of dexamethasone from a dose of BBI608.
16074115|NCT02352558|Drug|Bortezomib|Bortezomib will be administered at 1.3 mg/m2/dose as a 3-5 second bolus intravenous (IV) injection or subcutaneous injection twice weekly for 2 weeks (Day 1, 4, 8, and 11) followed by a 10-day rest period (Day 12-21).
16074116|NCT02352558|Drug|Imatinib|Imatinib will be taken orally once daily with a meal and a large glass of water. For patients having difficulty swallowing, imatinib can be dissolved in water or apple juice for intake. The dose of imatinib is 400 mg for CML patients in the chronic phase and 600 mg for CML patients in the accelerated phase or in blast crisis. A minimum of 2 hours should separate a dose of imatinib from a dose of BBI608.
16074117|NCT02352558|Drug|Ibrutinib|Ibrutinib will be taken orally once daily with water. Do not open, break, or chew the capsules. The dose of ibrutinib is 420 mg for patients with normal liver function and is 140 mg for patients with mild liver impairment (Child-Pugh class A). A minimum of 2 hours should separate a dose of ibrutinib from a dose of BBI608.
16074118|NCT02352545|Drug|Montelukast|Patients in experimental treatment arm were given Montelukast Sodium Tablets (p.o., 10mg, q.d.) .
16074119|NCT02352532|Other|Dry Needling|"The dry-needling treatment will consist of inserting a sterile needle into needling the prone participant's lumbar multifidus and paraspinal muscles, 1-2 times each, in regions of local tenderness to palpation and/or regions with palpable trigger points. All needling treatment will be performed with FDA approved (FDA regulation # 880.5580) disposable 0.30 x 50-60 mm stainless steel Seirin J-type needles (Seirin, Japan). Each needle insertion will last approximately 5 seconds using a pistoning (in and out) technique."
16074120|NCT02352532|Other|Sham Needling|The sham dry-needling procedure will mimic the dry needling procedures by placing a sharp object in a needling guide tube against the skin (see figure). The sharp object will be rocked and twisted to simulate treatment, but will not pierce the skin. We have used this sham dry-needling technique in a previous study performed at AMEDDC&S and have found it to be indistinguishable from real dry needling by the great majority of participants.
16074121|NCT02352519|Procedure|UGBRSB|Under sterile conditions,the posterior rectus sheath will be identified by ultrasound, and an insulated 22 gauge 50 mm needle inserted till the tip is seen to be directly between the rectus abdominis muscle and the posterior rectus sheath. Bupivacaine 0.25% (0.2 ml/kg with maximum 5 ml in each side) will be injected observing the spread on the ultrasound image.
16074122|NCT02352519|Procedure|Local Infiltration|In those patients randomized to the LAI group, the surgeon will perform infiltration of 0.5 ml/kg of 0.25% bupivacaine (maximum, 10 ml) around the incision
16074123|NCT02352506|Other|Blood draw for measurement of MIF|Observational study, no intervention
16074124|NCT02352493|Drug|ALN-CC5|Single or multiple doses of ALN-CC5 by subcutaneous (sc) injection
16074125|NCT02352493|Drug|Sterile Normal Saline (0.9% NaCl)|calculated volume to match active comparator
16074126|NCT02352480|Device|Aurix|Aurix is a platelet-rich plasma (PRP) gel used in the treatment of non-healing chronic wounds. It will be administered twice weekly for 2 weeks then weekly.
16074127|NCT02352467|Device|Aurix|Aurix is a platelet-rich plasma gel used in the treatment of non-healing wounds. It will be administered twice weekly for 2 weeks then weekly.
16074128|NCT02352454|Device|Aurix|Aurix is a platelet-rich plasma gel used in the treatment of non-healing wounds. It will be administered twice weekly for 2 weeks then weekly.
16074129|NCT02352441|Other|Implementation Intentions(II)|"Implementation Intention training will include:
~Demonstration and practice using examples and personal goals identified at first session. Worksheets will be provided to practice IF-THEN statements to set Implementation Intentions. Additionally, at the end of each session, the participant will be instructed to perform and event based or time based task. The objective is to see if those receiving II training are more likely to carry out the assigned task than those who do not receive II training. They will also be expected to practice II at least 5 days/week using personal goals."
16074169|NCT02352155|Procedure|epinephrine injection or heater probe or hemoclips|Elective Second look endoscopy in the following morning with re-treatment to the bleeding vessel using epinephrine injection or heater probe or hemoclips
16075232|NCT02344550|Drug|Letrozole|Letrozole 2.5 mg p.o. daily
16074130|NCT02352428|Other|Skin Cancer Screening Training|Topics of the 5.5-hour in-class course include: the screening test, types of skin cancer (signs and symptoms), case history taking, epidemiology of skin cancer, etiology, risk factors and risk groups, communicative aspects of primary and secondary preventive measures, and benefits and harms of cancer screenings.
16074131|NCT02352402|Drug|Ticagrelor|
16074132|NCT02352402|Drug|Placebo|
16074133|NCT02352389|Other|Blood sample|Blood samples will be drawn and analyzed at Day 0, 7, 14, 21, and 28
16074134|NCT02352389|Other|Nasal swab|Obtained on Day 0, 7, 14, 21 and 28.
16074135|NCT02352389|Other|Oropharyngeal swab|Obtained on Day 0, 7, 14, 21 and 28.
16074136|NCT02352389|Other|Stool sample|Obtained on Day 0, 7, 14, 21 and 28.
16074137|NCT02352389|Other|Symptom checklist|Obtained on Day 0, 7, 14, 21 and 28.
16074138|NCT02352376|Other|Conventional ventilator|A ventilator designed for invasive ventilation was used has mode non-invasive ventilation with leakage compensation (50% of the predetermined tidal volume).
16074139|NCT02352376|Other|Specific ventilator|A ventilator was used designed for non-invasive ventilation has an algorithm that calculates the loss of pressure and automatically compensates for leak
16074140|NCT02352363|Drug|CVT-301|
16074141|NCT02352363|Other|Observational cohort|
16074142|NCT02352350|Other|Blood Lactate Levels|Blood lactate levels will be performed on all participants.
16074143|NCT02352350|Other|Neurological Outcomes|Neurological outcomes will be performed on all participants based on the Cerebral Performance Categories (CPC) Scale.
16074144|NCT02352337|Drug|FOLFIRINOX|Perfusion :oxaliplatine, Irinotecan ,folinic acid, 5FU bolus and continue
16074145|NCT02352337|Drug|LV5FU2|Perfusion: Folinic Acid,5FU Bolus,5FU continue
16074146|NCT02352337|Drug|FOLFIRI.3|Perfusion :Irinotecan,Acide folinique ,5FU continue
16074147|NCT02352337|Drug|Gemcitabine|Gemcitabine perfusion
16074148|NCT02352324|Other|Fluid responsiveness tests|After the end of surgery in ICU the positive end-expiratory pressure (PEEP) test of 15 cm H2O for 300 seconds will be performed. Following PEEP test, the two-step fluid load test of 6 ml/kg balanced crystalloid solution will be performed sharing in two portions: Initial mini FLT (mFLT) of 1.5 ml/kg within 1 min (approximately 100 mL) followed by the registration of continuous CI and traditional fluid responsiveness parameters and the rest of standard FLT (4.5 mL/kg) within 5 minutes (approximately 350 mL) followed by transpulmonary thermodilution, registration of continuous cardiac index (CI) and classic fluid responsiveness parameters.
16074149|NCT02352311|Drug|DKF-313|Combination of dutasteride 0.5 mg and tadalafil 5 mg
16074150|NCT02352311|Drug|AVODART|Dutasteride 0.5 mg
16074151|NCT02352311|Drug|CIALIS|Tadalafil 5 mg
16074152|NCT02352298|Device|Dario Blood Glucose Monitoring System|Fingerstick to obtain blood sample for analysis with the Dario BGMS
16074153|NCT02352298|Device|YSI Analyzer|Fingerstick to obtain blood sample for analysis with YSI
16074154|NCT02352285|Drug|Tolvaptan|Start with 15mg to titrate upwards to 30mg to 60mg, once a daily
16074155|NCT02352285|Drug|Placebo|Start with 15mg to titrate upwards to 30mg to 60mg, once a daily
16074156|NCT02352272|Other|Total Sleep deprivation|Subject are submitted to 39 hours of continuous awaking in laboratory and a recovery night
16074157|NCT02352259|Procedure|Electrochemotherapy|Treatment procedure: anesthesia, positioning of electrodes, intravenous in bolus administration of bleomycin, within 8-30 min after administration of bleomycin application of electric pulses, removal of electrodes.
16074158|NCT02352259|Device|Cliniporator Vitae®|Positioning of electrodes, within 8-30 min after administration of bleomycin application of electric pulses (8 pulses, duration 100 microseconds, frequency 4 Hz with amplitude adequate to cover the whole treated lesion with electric field necessary for reversible plasma membrane permeabilization), removal of electrodes.
16074159|NCT02352259|Drug|Bleomycin PHC 15 e. (United States Pharmacopeia - USP)|Intravenous in bolus administration of bleomycin (15 mg/m2), 8 minutes before application of electric pulses
16074160|NCT02352246|Procedure|Physical activity programs steady-state exercise (SSE) program|The aim of our study was to compare the effects of 16-week steady-state exercise (SSE) program with high intensity intermittent exercise (HIIE) program on total abdominal and visceral fat mass in T2D postmenopausal women.
16074161|NCT02352246|Procedure|Physical activity programs high intensity intermittent exercise (HIIE)|
16074162|NCT02352233|Procedure|RETROVIEW colonoscope|withdrawal in retro vision and forward vision was performed by segments (right, transverse, left, sigmoid colon and rectum). Retroflexed therapeutics procedures were executed when needed.
16074163|NCT02352207|Other|identification of a pulmonary malformation in the fetus|
16074164|NCT02352194|Other|Rehabilitation|Physiotherapy and physical activity
16074165|NCT02352181|Procedure|Conventional coagulation profile Analysis|"Transfusional protocol for Standard group Red Blood cells concentrate if Hemoglobin <9 gram per liter Fibrinogen 3 gram, if fibrinogen <1gram per liter
~Platelet concentrate :
~if platelets <50gram per liter before transfusion, at anhepatic phase, or in case of bleeding.
~if platelets <30gram per liter at vascular unclamping time at the end of intervention or without bleeding 2 Fresh frozen plasma if :
~if prothrombin<40% before transfusion at anhepatic phase or in case of bleeding.
~if prothrombin<30% at vascular unclamping time at the end of intervention or without bleeding Bolus Tranexamic acid 1g and 3g every 24 hours in case of fibrin degradation products.
~Analyses common to both groups: NFS, chemistry panel with ionized serum calcium, blood gas with lactates, HemoCue ®, capillary blood glucose.
~Analyses in S Group only: coagulation profile (PT, APTT, INR, fibrinogen, platelet count, soluble complexes, PDF)."
16074166|NCT02352181|Procedure|Rotem analysis|"Transfusional protocol for Rotem group. Red Blood cells concentrate if Hemoglobin <9 gram per liter Fibrinogen 3 gram, if A10 FIBTEM <8 mm
~Platelet concentrate :
~If MCF EXTEM <40mm or A10<35 mm and MCF or A10 FIBTEM >8mm.
~If platelets <30gram per liter at vascular unclamping time at the end of intervention or without bleeding.
~2 Fresh frozen plasma if CT EXTEM >100s.
~Bolus Tranexamic acid 1g and 3g every 24 hours :
~if fibrinolysis in EXTEM
~Reduction of 15 % of clotting time or clot formation time and increase of maximum clot firmness in APTEM compared to EXTEM, or maximal lysis at 60 minutes >15%.
~Analyses in R group only: blood sampling on citrated tube for ROTEM analysis (EXTEM, INTEM, FIBTEM, APTEM +/- HEPTEM), coagulation profile (same as that of the S Group, for emergency procedure).
~Analyses common to both groups: NFS, chemistry panel with ionized serum calcium, blood gas with lactates, HemoCue ®, capillary blood glucose."
16074170|NCT02352155|Other|Observation only|Observation for rebleeding, unscheduled endoscopy only when rebleeding criteria fulfilled
16074171|NCT02352142|Other|Full Term EEG|Full-term infants assigned to this arm of the study will receive one sleep EEG (one hour in duration). These EEGs will be used as healthy control comparisons to those of premature infants at 40 weeks.
16074172|NCT02352142|Behavioral|Facilitated Infant Care|Family Nurture Intervention is facilitated by specially trained Nurture Specialists. The intervention involves calming interactions between mother and infant in the isolette via odor exchange, firm sustained touch and vocal soothing, through calming interactions during holding and feeding via the Calming Cycle and through family sessions designed to engage the help and support of family members for the mother.
16074173|NCT02352129|Other|CMR using T1 mapping technique|the level of myocardial fibrosis for patient suffering of cardiomyopathy dilated will be quantified using CMR T1 mapping technique
16074174|NCT02352116|Other|Additional face-to-face education|Additional teaching regarding what to expect in terms of postoperative pain, how to properly identify pain in children, and instruction on the proper administration of analgesic medications
16074175|NCT02352116|Other|Standard of care management|Current standard of care at a major U.S. teaching hospital.
16074176|NCT02352103|Procedure|Retzius sparing radical prostatectomy|Robotic assisted laparoscopic radical prostatectomy based on Retzius sparing technique
16074177|NCT02352103|Procedure|Vattikuti Urology Institute radical prostatectomy|Robotic assisted laparoscopic radical prostatectomy based on Vattikuti Urology Institute technique
16074178|NCT02352103|Device|da Vinci Surgical System|The da Vinci Surgical System is a sophisticated robotic platform designed to expand the surgeon's capabilities and offer a state-of-the-art minimally invasive option for major surgery.
16074179|NCT02352090|Drug|Ethinyl estradiol / dienogest|One tablet orally for 9 weeks, continuous use
16074180|NCT02352090|Drug|Estradiol valerate / dienogest|One tablet orally for 9 weeks, continuous use
16074181|NCT02352090|Drug|Dienogest|One tablet orally for 9 weeks, continuous use
16074182|NCT02352077|Biological|NeuroRegen scaffold with BMMCs or MSCs transplantation|Patients with chronic SCI (ASIA grade A) will receive NeuroRegen Scaffold with bone marrow mononuclear cells (BMMCs) or mesenchymal stem cells (MSCs) transplantation after localized scars cleared and after surgery patients will undergo a comprehensive rehabilitation, psychological and nutritional measures.
16074183|NCT02352064|Procedure|PET (18-FDG)|Every patient will have a PET
16074184|NCT02352051|Drug|Atomoxetine|the drug was initiated at a dose of 0.5 mg/kg/day which was then gradually increased at 2-week intervals and it was attempted to titrate the dose to 1.2 mg/kg/day.
16074185|NCT02352051|Drug|methylphenidate|the drug was initiated at the lowest commercially available dose this was then increased at one-month intervals and it was attempted to titrate the dose to 1 mg/kg/day using daily doses of 36-54 mg
16074186|NCT02352038|Device|low-level laser therapy|The test teeth will receive LLLT using a 940 nanometer diode laser (EZLASE; BIOLASE Technology Inc., Irvine, CA, USA) with output power of 330 milliwatt. The experimental side was irradiated for 30 s in two sessions, delivering an energy density of 7 Joules per square centimeter.
16074187|NCT02352038|Other|orthodontic treatment|Orthodontic treatment will be carried out using preadjusted appliances with bonded 0.022×0.028-square inch brackets/buccal tubes and 0.014-inch NiTi archwires as the first archwires. The treatment or the major part of the treatment will be completed in 12 months.
16074188|NCT02352025|Drug|S-equol|S-equol should be administered orally, twice daily (12 hours apart), preferably on an empty stomach with a glass of water. Tablets should be swallowed whole.
16074189|NCT02352012|Other|Autologous blood|Autologous blood was perfused to the target pulmonary segment
16074190|NCT02352012|Device|Bronchial plug|Bronchial plug was placed to the target pulmonary segment
16074191|NCT02351999|Device|TSP Crosser Transseptal Access System|for transseptal puncture, left atrial access and catheter navigation.
16074192|NCT02351986|Procedure|physical therapy|A 20 minutes ice pack cryotherapy applied for 4 consecutive days
16074193|NCT02351986|Other|ice pack|
16074194|NCT02351973|Drug|Hydrochlorthiazide|"HCTZ 25mg to 50mg All drugs will be provided in an acceptable container where the active agent is not identified on the drug label.
~In Phase 1 (weeks 0-12) patients will have 1 tablet from each of 2 bottles. These will contain either a) HCTZ 12.5mg in both bottles; b) amiloride 5mg in both bottles; OR c) one bottle of each.
~In Phase 2 (weeks13-24) patients will take 2 tablets from each of 2 bottles. These bottles will have the same contents as in Phase 1, except that the number of tablets will be twice as many."
16074195|NCT02351973|Drug|Amiloride|"Amiloride 10mg to 20mg All drugs will be provided in an acceptable container where the active agent is not identified on the drug label.
~In Phase 1 (weeks 0-12) patients will have 1 tablet from each of 2 bottles. These will contain either a) HCTZ 12.5mg in both bottles; b) amiloride 5mg in both bottles; OR c) one bottle of each.
~In Phase 2 (weeks13-24) patients will take 2 tablets from each of 2 bottles. These bottles will have the same contents as in Phase 1, except that the number of tablets will be twice as many."
16074196|NCT02351973|Drug|Hydrochlorthiazide and Amiloride|"HCTZ 12.5 to 25mg & + Amiloride 5mg to 10mg All drugs will be provided in an acceptable container where the active agent is not identified on the drug label.
~In Phase 1 (weeks 0-12) patients will have 1 tablet from each of 2 bottles. These will contain either a) HCTZ 12.5mg in both bottles; b) amiloride 5mg in both bottles; OR c) one bottle of each.
~In Phase 2 (weeks13-24) patients will take 2 tablets from each of 2 bottles. These bottles will have the same contents as in Phase 1, except that the number of tablets will be twice as many."
16074197|NCT02351960|Drug|Dexlansoprazole|Dexlansoprazole capsules
16074198|NCT02351947|Other|upper limb rehabilitation for chronic stroke|subjects in this group will receive upper limb motor learning rehabilitation and undergo fMRI/EEG testing as well as testing of motor function (AMAT and FM).
16074199|NCT02351934|Drug|Furosemide|
16074200|NCT02351934|Drug|Celecoxib|Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain or inflammation.
16074201|NCT02351934|Drug|Gabapentin|Gabapentin is a oral drug used to treat seizures, postherpetic neuralgia, and restless legs syndrome.
16074202|NCT02351921|Device|Transcranial magnetic stimulation|Intermittent theta-burst stimulation is a form of repetitive Transcranial magnetic stimulation. ITBS is a non-invasive, non-painful procedure being used worldwide to study brain function and promote short-term changes (~1 hour) in neural activity in the brain. The delivery of cTBS requires ~ 40 seconds in total.
16074203|NCT02351908|Drug|Stribild® (Tenofovir Disoproxil Fumarate, Elvitegravir, Cobicistat)|
16074204|NCT02351908|Drug|Isentress® (Raltegravir 400 mg)1 tablet twice a day + Truvada® (FTC & Tenofovir) 1 tablet|
16074205|NCT02351908|Drug|Tivicay® (Dolutegravir 50 mg) 1 tablet once a day + Truvada® (FTC & Tenofovir)|
16074206|NCT02351895|Other|Copper impregnated linen|Copper impregnated linen was used in place of regular linen on one ward (out of two) for each period of the study. Each study period lasted for 23 weeks. After the washout period (3 weeks) the wards were switched.
16074207|NCT02351882|Drug|Nabilone|Participants randomized to nabilone treatment arm, will undergo a one-week placebo washout, followed by 6 weeks of nabilone treatment (weeks 1-6). Participants will then receive a one-week placebo washout (week 7), before receiving 6 weeks of placebo treatment (weeks 8-14).
16074208|NCT02351882|Drug|Placebo|Participants randomized to placebo arm, will undergo a one-week placebo washout, followed by 6 weeks of drug matched placebo (weeks 1-6). Participants will then receive a one-week placebo washout (week 7), before receiving 6 weeks of nabilone treatment (weeks 8-14).
16074209|NCT02351869|Drug|Nitrous Oxide|
16074210|NCT02351869|Drug|Midazolam|
16074211|NCT02351856|Drug|ARRY-371797, p38 inhibitor, oral|multiple dose, single schedule
16074212|NCT02351843|Device|MECTA Spectrum 5000Q|
16074213|NCT02351830|Other|Birch Pollen|Participants will be exposed to birch pollen to activate their allergy symptoms therefore validating the unit.
16074214|NCT02351830|Procedure|Nasal Brushing|To assess allergic biomarkers participants will provide a nasal sample which will be collected using a cytobrush. This procedure will be performed twice; once at screening and once following pollen exposure in the EEU.
16074215|NCT02351817|Device|Test A|Ostomy appliance
16074216|NCT02351817|Device|Test B|Ostomy appliance
16074217|NCT02351817|Device|Baseline|Ostomy appliance
16074218|NCT02351804|Drug|Ropivacaine + dexamethasone|Adductor canal block, single bolus
16074219|NCT02351804|Drug|Ropivacaine + placebo|Adductor canal block, single bolus
16074220|NCT02351791|Other|Patch 1, Center|
16074221|NCT02351791|Other|Patch 1, Leakage pocket|
16074222|NCT02351791|Other|Patch 1, Adhesive|
16074223|NCT02351791|Other|Patch 2, Center|
16074224|NCT02351791|Other|Patch 2, Leakage pocket|
16074225|NCT02351791|Other|Patch 2, Adhesive|
16074226|NCT02351791|Other|Patch 3, Center|
16074227|NCT02351791|Other|Patch 3, Leakage pocket|
16074228|NCT02351791|Other|Patch 3, Adhesive|
16074229|NCT02351791|Other|Patch 4, Center|
16074230|NCT02351791|Other|Patch 4, Leakage pocket|
16074231|NCT02351791|Other|Patch 4, Adhesive|
16074232|NCT02351791|Other|Patch 5, Center|
16074233|NCT02351791|Other|Patch 5, Leakage pocket|
16074234|NCT02351791|Other|Patch 5, Adhesive|
16074235|NCT02351791|Other|Patch 6, Center|
16074236|NCT02351791|Other|Patch 6, Leakage pocket|
16074237|NCT02351791|Other|Patch 6, Adhesive|
16074238|NCT02351765|Drug|Acelarin|First-in-class nucleotide analogue
16074239|NCT02351765|Drug|Cisplatin|Platinum-compound chemotherapy drug
16074240|NCT02351752|Drug|Hydroxychloroquine Sulfate|Hydroxychloroquine Sulfate: 0.1 Tid(eGFR 30-59);0.2 Bid (eGFR>60)
16074241|NCT02351739|Drug|pembrolizumab|
16074242|NCT02351739|Drug|ACP-196 in combination with pembrolizumab|
16074243|NCT02351726|Device|Mitroflow DL|Treatment with Mitroflow Pericardial Aortic Heart Valve with Phospholipid Reduction Therapy (Model DL)
16074244|NCT02351713|Other|Exercise|Continuous aerobic exercise prescribed according to two exercise intensity methods: threshold based method (i.e., ventilatory threshold) and relative percent method (i.e., heart rate reserve).
16074247|NCT02351687|Dietary Supplement|Lipid Nutrient Supplement|
16074248|NCT02351687|Drug|Sulfadoxine-pyrimethamine|
16074249|NCT02351687|Drug|Albendazole|
16074250|NCT02351687|Drug|Zinc|
16074251|NCT02351687|Other|Insecticide-treated bednet|
16074252|NCT02351661|Other|There was no intervention|observational study, no intervention
16074253|NCT02351648|Other|a transitional care model|"Intervention extend from transfer of care to the study team from the initial admission medical team through 90 days after discharge
~Intervention in hospital includes the following. Comprehensive discharge planning based on the 6 principles. Discharge planning initially within 24 hours of recruitment Daily ward review of patients Weekly multi-disciplinary meeting Consolidation of medication and follow-up appointment before discharge Assessment of needs before discharge Comprehensive discharge summary and medication record at discharge
~Intervention after discharge:
~Work done mainly by integrated care nurse Review of patients within 48 hours after discharge via home visit or phone call Subsequent home visit as needed based on patient's needs At least weekly contact with pt or caregiver via telephone Telephone availability working weekday 8 AM to 5 PM Multi-disciplinary meeting for problematic cases Use chronic disease pathway for suitable patients"
16074254|NCT02351648|Other|Control|Patients receive usual standard of care from the internal medicine team
16074255|NCT02351635|Other|fecal calprotectin level|Stool sample collected by the subject, sent study laboratories where fecal calprotectin levels are quantified.
16074256|NCT02351622|Drug|Caffeic acid|Oral administration of caffeic acid tablet 0.3g three times per day for 1 year
16074257|NCT02351622|Drug|Dexamethasone|Oral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later, 3 cycles in total.
16074258|NCT02351622|Drug|Placebo|Sugar pills manufactured to mimic caffeic acid tablet. Oral administration of placebo tablet 0.3g three times per day for 1 year.
16074303|NCT02351271|Device|Femto LDV Z8|Femtosecond laser-assisted cataract pre-treatment: Capsulotomy and lens fragmentation, followed by ultrasound phacoemulsification
16074259|NCT02351609|Behavioral|Intervention|"Intervention patients will be introduced to the patient navigator either in person or by telephone. The intervention patients will receive navigation from one of two trained navigators, based centrally in the Section of General Internal Medicine. The purpose of the patient navigation interactions is to 1) connect patients to existing yet underutilized smoking cessation resources and 2) increase patient commitment to follow through with existing treatment services.
~Financial incentives: $250 for biochemically confirmed abstinence within six months after study enrollment, and $500 for biochemically confirmed abstinence for an additional six months after the initial cessation."
16074260|NCT02351609|Other|Enhanced Traditional Care control|List of smoking cessation resources and educational brochure.
16074261|NCT02351596|Other|Physiotherapy Core Stability Group Programme|"The aim of the intervention is to teach the participants active alignment and core stability, in order to influence their balance strategies. The exercises carried out will teach participants how and when to activate deep core stabilizing muscles. These exercises will be taught in a child-friendly way using imagery appropriate for the age of the participants. They will carry out activities like wall squats, 4-point kneeling, Transverses abdominis activation and gym ball sitting.
~Participants will also be supplied with a Home Exercise Programme (HEP) sheet with explanations for exercises that they will be asked to carry out on their 'off' days over the 4 week period. They will be asked to keep a record of their compliance with this."
16074262|NCT02351596|Other|Control Group|The control group will partake in their usual physiotherapy care during the 4 week control period. They will not include core stability or balance specific exercises in their physiotherapy programme for the duration of the control period. If they are receiving active physiotherapy treatment during this time, the duration and frequency of this intervention is recorded
16074263|NCT02351583|Device|CytoCam|The side-stream darkfield camera ( CytoCam) will be put under the subjects tongue for 5-10 minutes. Multiple pictures of the small blood vessels will be taken.
16074264|NCT02351583|Device|NIRS Artinis PortaLite with OxySoft softwear|. The NIRS probe will be applied to one of the patient's thenar muscle and over the patient forehead and tissue oxygenation (TOI) will be recorded for 5 minutes.
16074265|NCT02351544|Drug|Botulinum Toxin Type A|
16074266|NCT02351544|Procedure|Surgery|
16074267|NCT02351544|Other|Daily headache diary|
16074268|NCT02351544|Other|Migraine Disability Assessment Test (MIDAS)|
16074269|NCT02351544|Other|Migraine Work and Productivity Loss Questionnaire (MWPLQ)|
16074270|NCT02351544|Other|Migraine-Specific Quality of Life Questionnaire (MSQ)|
16074271|NCT02351531|Dietary Supplement|Extensively Hydrolyzed formula|
16074272|NCT02351518|Other|No intervention|There will be no interventions in this study
16074273|NCT02351505|Drug|Selinexor|Given PO
16074274|NCT02351505|Other|Laboratory Biomarker Analysis|Correlative studies
16074275|NCT02351505|Other|Pharmacological Study|Correlative studies
16074276|NCT02351492|Procedure|Cholecystectomy and intraoperative cholangiography|Patients with suspected bile duct obstruction intraoperative cholangiography IOC to investigate bile ducts.
16074277|NCT02351492|Procedure|Magnet resonance cholangio-pancreaticography|Patients get Magnet resonance cholangio-pancreaticography MRCP first. In case of detected gallstones, removal of the stones by endoscopic retrograde cholangiopancreaticography will be performed before gallbladder removal.
16074278|NCT02351492|Device|magnet resonance imaging|Patients get Magnet resonance cholangio-pancreaticography MRCP first. In case of detected gallstones, removal of the stones by endoscopic retrograde cholangiopancreaticography will be performed before gallbladder removal.
16074279|NCT02351492|Device|catheter|Patients with suspected bile duct obstruction intraoperative cholangiography IOC to investigate bile ducts.
16074280|NCT02351479|Behavioral|Hula|
16074281|NCT02351466|Other|Observational|
16074282|NCT02351440|Drug|duloxetine|patients will be randomized to receive either duloxetine or placebo
16074283|NCT02351440|Drug|placebo|placebo
16074284|NCT02351427|Drug|Bortezomib|In one group, investigators administer bortezomib and steroid to manage acute cellular rejection in kidney transplantation, and compare the results with another group in which only steroid was administered.
16074285|NCT02351427|Drug|Steroid|Investigators administer steroid in both groups for conventional treatment of acute cellular rejection.
16074286|NCT02351414|Device|Total Knee Arthroplasty (EVOLUTION®)|
16074287|NCT02351401|Behavioral|Education using ultrasonography as feedback tool|Education using ultrasonography as feedback tool
16074288|NCT02351388|Device|Transcranial Direct Current Stimulation|
16074289|NCT02351388|Other|Sham Stimulation|
16074290|NCT02351375|Other|diet|A controlled diet will be provided to participants which consists of either high protein/low carbohydrate, or of low protein/high carbohydrate.
16074291|NCT02351375|Device|IntelliCap® system|
16074292|NCT02351362|Behavioral|Incentive Group|A one-time supermarket voucher of R50 (about $5.00) for participants who return for at least one postpartum visit at the study clinic within 10 weeks of delivery
16074293|NCT02351349|Other|multidisciplinary intervention|multidisciplinary intervention
16074294|NCT02351336|Device|Ultrasound imaging|"- Fetal adrenal gland volume calculation using 3D ultrasound ( in mm3)
~- corrected adrenal gland volume calculation ( adrenal gland volume (mm3)/ estimated fetal weight (kg) )
~- CL measurement using 2D ultrasound ( in cm)"
16074295|NCT02351323|Drug|Glutamine (Pharmacological doses)|30 grams/day of glutamine for 12-14 months
16074296|NCT02351323|Behavioral|Lifestyle change|Lifestyle change as recommended by Registered Dietitian
16074297|NCT02351310|Drug|Betamethasone|Course of ACS given intramuscularly (2 doses of 12 mg, 24 hours apart)
16074298|NCT02351310|Genetic|Placebo|Course of placebo drug given intramuscularly (2 doses of normal saline (of equal quantity) 24 hours apart).
16074299|NCT02351297|Dietary Supplement|casein supplementation|After the run-in period, volunteers will receive casein supplementation (15 % of energy intake) for 3 weeks.
16074300|NCT02351297|Dietary Supplement|soy protein supplementation|After the run-in period, volunteers will receive soy protein supplementation (15 % of energy intake) for 3 weeks.
16074301|NCT02351297|Dietary Supplement|maltodextrin supplementation|After the run-in period, volunteers will receive maltodextrin supplementation (15 % of energy intake) for 3 weeks.
16075521|NCT02342678|Behavioral|Physical Conditioning|
16074304|NCT02351271|Device|Manual capsulorhexis&lens fragmentation|Control treatment where the capsulorhexis is performed manually and the lens fragmentation is performed by the stop and chop technique with the phaco emulsification device
16074305|NCT02351258|Device|70% Isopropyl alcohol embedded caps|Protective cap on central lines
16074306|NCT02351258|Other|Usual Care|"This involves the Best Practice Central Line Maintenance Care Bundle which includes;
~Daily assessment whether central line is needed
~Central line Site Care
~Central line Hub/Cap/Tubing Care"
16074307|NCT02351245|Other|observation|
16074308|NCT02351232|Drug|Liraglutide|
16074309|NCT02351232|Drug|Placebo|
16074310|NCT02351219|Drug|FOLFOXIRI|
16074311|NCT02351206|Radiation|x-ray, MRI|
16074312|NCT02351193|Other|transvaginal Ultrasound|
16074313|NCT02351180|Drug|Inhaled beclomethasone|Inhaled steroid that may decrease airway inflammation and the risk of chronic rejection
16074314|NCT02351180|Drug|Placebo|Placebo will serve as a control treatment
16074315|NCT02351167|Drug|Combination NRT (Nicotine patch, Nicotine lozenge)|
16074316|NCT02351167|Drug|Varenicline|
16074317|NCT02351167|Drug|Placebo|
16074318|NCT02351167|Behavioral|Intensive smoking counseling|
16074319|NCT02351154|Other|Cellvizio Viewer software|permets to perform analysis of diameters in micrometers
16074320|NCT02351141|Other|Hyperpolarized Noble Gas MRI|"Hyperpolarized Helium-3 and/or Xenon-129. Noble gas magnetic resonance imaging (MRI) has recently emerged as another research approach for the non-invasive measurement of lung structure and function, including conduction of gas through airways and into airspaces.
~Noble gas MRI provides a complimentary and alternative method for evaluating lung disease and may be superior to CT because it allows simultaneous visualization of both airway and airspace structure and function."
16074321|NCT02351128|Drug|Lanreotide|
16074322|NCT02351115|Drug|A=Placebo|
16074323|NCT02351115|Drug|B=Inhaled Alprazolam 0.5 mg|
16074324|NCT02351115|Drug|C=Inhaled Alprazolam 1 m|
16074325|NCT02351115|Drug|D= Inhaled Alprazolam 2 mg|
16074326|NCT02351115|Drug|E=Placebo|
16074327|NCT02351102|Drug|Valacyclovir|
16074328|NCT02351102|Drug|Placebo|
16074329|NCT02351089|Dietary Supplement|Capsules placebo|Capsules
16074330|NCT02351089|Dietary Supplement|Capsules probiotic powder and corn starch|
16074331|NCT02351063|Drug|Changes of heart failure medications|Changes in dosage of existing medications or introduction of new medications to improve heart failure condition.
16074332|NCT02351050|Device|Sonolysis|continual transcranial Doppler monitoring of middle cerebral artery
16074333|NCT02351050|Other|Sham procedure|sham transcranial Doppler monitoring of middle cerebral artery
16074334|NCT02351037|Drug|Ibrutinib|Subjects will receive ibrutinib 560 mg once daily on a continuing basis.
16074335|NCT02351037|Drug|Ibrutinib + LD-AraC|Subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 2 days prior to first cytarabine dose (20 mg BID sc) for 10 days of a 28-day cycle.
16074336|NCT02351037|Drug|Ibrutinib+Azacitidine|Subjects will receive ibrutinib 560 mg once daily on a continuous basis starting 1 day prior to first azacitidine dose + azacitidine 75 mg/m2 IV once daily on Days 1-7 of a 28-day cycle (with an option to increase to 100 mg/m2 after 2 cycles).
16074337|NCT02351024|Drug|OXP005|
16074338|NCT02351024|Drug|Naprosyn®|
16074339|NCT02351011|Biological|1 x 10^6 MSCs|Autologous, bone-marrow derived MSCs
16074340|NCT02351011|Biological|10 x 10^6 MSCs|Autologous, bone-marrow derived MSCs
16074341|NCT02351011|Biological|50 x 10^6 MSCs|Autologous, bone-marrow derived MSCs
16074342|NCT02350998|Drug|OTO-201|
16074343|NCT02350985|Drug|Propranolol|Propranolol was given in a flexible dose between 40 mg to 160 mg with an escalating fashion starting at 40 mg PO AM for one week and followed by 40 mg AM and 40 mg PM for a total dose up to 160 mg daily
16074344|NCT02350985|Drug|Venlafaxine|Venlafaxine treatment was followed as: 37.5 mg qhs for two weeks and followed 75 mg qhs with an escalating dose with 2 weeks periods up to 150 mg daily
16074345|NCT02350972|Biological|Autologous cytokines|Sterile autologous cytokines were injected weekly into multiple metastatic nodules while other nodules in the patient were never injected and were monitored for the development of dense lymphocytic infiltrates as evidence of an induced immune response.
16074346|NCT02350959|Drug|Atorvastatin|in moderate dosea statin group, atorvastatin 10mg will be used and maintained until follow up angiography
16074347|NCT02350959|Drug|Atorvastatin|in high dose statin group, atorvastatin 40mg will be used and maintained until follow up angiography
16074348|NCT02350946|Drug|Oxytocin|
16074349|NCT02350946|Drug|Placebo|
16074350|NCT02350933|Procedure|Endoscopy|A rigid endoscopy of the larynx and the trachea until the carina is performed using a rigid 0° endoscope.
16074351|NCT02350920|Behavioral|Acceptance and Committment Therapy (ACT)|This intervention will run with 12-15 participants in each group for a duration of 8 weeks. Each group session will last 1-1.5 hours.
16074352|NCT02350894|Behavioral|Graded and behavevial theraphy|Graded and behavevial theraphy
16074353|NCT02350881|Device|Primus FGTI (Flexible Great toe Implant)|Great toe arthroplasty consists of replacing the first Meta-Tarso-Phalangeal (MTP1) joint by a two hinged prosthesis made of silicone : the Primus FGT implant (FGTI). The Primus is designed with an axially offset hinge to align with the anatomy of the MTP joint. This results in less implant stresses and improved toe function.
16074354|NCT02350868|Drug|MPT0E028|The starting dose in the Dose Escalation Phase will be 50 mg/day.Dose escalation from the first cohort to the second cohort will be doubled; and from the second cohort to the fourth cohort will proceed at no more than 50% increments.
16074355|NCT02350855|Dietary Supplement|Improved Atta|Improved Atta is a multi macro- micronutrient bread mix. Patients were given 100 grams of Improved Atta (in the from of unleavened bread) everyday for consumption for six months.
16074356|NCT02350855|Other|Nutritional counseling|Dietary counseling for 30 minutes was imparted to all patients on every hospital visits by the researcher. Consumption of cereals, roots and tubers, vegetables, legumes, nuts, energy dense fruits, milk products (and eggs for non-vegetarians) was encouraged in their daily diets.
16074357|NCT02350855|Behavioral|Physical activity counseling|Depending on the physical status of the patients, low level of physical activity (walking and/or stairs), was encouraged daily during counseling sessions.
16074358|NCT02350842|Device|triple-site biventricular pacing with peri-operative echo guidance|placement of the third lead by peri-operative echo guidance.
16074359|NCT02350842|Device|standard biventricular pacing|standard biventricular pacing without optimization by echo guidance
16074360|NCT02350829|Other|Cardiac magnetic resonance sequence T1 mapping|Adding T1 mapping sequence to the clinical cardiac magnetic resonance scan Obtaining bloodwork for assessment of hematocrit and collagen biomarkers
16074361|NCT02350816|Drug|HGT-1410|HGT-1410 administered according to Patient Group assignment.
16074362|NCT02350803|Device|mini plate|in the intervention group, 4 L shaped titanium mini plates with 16 screws were fixed immediately after distraction phase and removal of distraction ossteogenesis to prevent the relapse after distraction
16074363|NCT02350790|Procedure|Robotic ablation|Robotic laparoscopic ablation of endometriosis with the argon beam coagulator (ABC)
16074364|NCT02350790|Procedure|Robotic excision|Robotic excision of endometriosis
16074365|NCT02350777|Procedure|Donor peripheral blood progenitor cells: stimulation, harvesting, isolation and T-cell depletion|For related donors, beginning 5-6 days before the day of HPC(A) or HPC (M) TCD boost infusion, the normal donor will receive GCSF per institutional guidelines. On the fifth and sixth days of this course of G-CSF, the donor will undergo daily leukapheresis designed to provide a minimum of 5x10^6 CD34+ cells/kg of the transplant recipient's weight. For unrelated donors, the G-CSF will be administered and the leukapheresis obtained according to the National Marrow Donor Program protocol IND, and institutional guidelines. Mononuclear cell fractions (i.e., CD34+ cells) collected on the fourth and fifth days will be pooled.
16074366|NCT02350777|Device|CliniMACS Cell Selection System|
16074367|NCT02350764|Drug|nivolumab|
16074368|NCT02350764|Drug|pilimumab|
16074369|NCT02350751|Drug|MEDI8852|
16074370|NCT02350751|Drug|Placebo|
16074371|NCT02350738|Other|Period I MCET (8 wks)|MCET_Mock group: Multimodal Cognitive Enhancement Therapy (MCET) (3 sessions/wk) Mock_MCET group: mock-therapy (3 sessions/wk)
16074372|NCT02350738|Other|Washout (4 wks)|4 weeks wash-out period in both arms and cross-over
16074373|NCT02350738|Other|Period II MCET (8 wks)|MCET_Mock group: mock therapy (MCET) (3 sessions/wk) Mock_MCET group: Multimodal Cognitive Enhancement Therapy (MCET) (3 sessions/wk)
16074374|NCT02350725|Drug|Furosemide injection solution for subcutaneous administration (80 mg)|
16074375|NCT02350725|Drug|Oral Furosemide tablets (80 mg)|
16074376|NCT02350712|Drug|Patritumab|Patritumab initial loading dose is 18 mg/kg IV over 60 minutes, followed in Cycle 2 and beyond with a maintenance dose of 9 mg/kg IV over 60 minutes (+/- 10 minutes) every 3 weeks. Infusion time can be extended to a maximum of 120 minutes for participants unable to tolerate the 60-minute infusion.
16074377|NCT02350712|Drug|Cetuximab|Cetuximab initial dose at 400 mg/m2 IV as a 2-hour infusion, followed by 250 mg/m2 IV over 60 minutes weekly.
16074378|NCT02350712|Drug|Cisplatin|Cisplatin is given as an IV infusion, over 1 hour, 1 hour after the cetuximab infusion, every 3 weeks up to a maximum of 6 cycles (with standard pre- or post-treatment therapies at the investigator's discretion).
16074379|NCT02350712|Drug|Carboplatin|Carboplatin is given as an IV-bolus, over 30-60 minutes, every 3 weeks, for a maximum of 6 cycles (with standard pre- or post-treatment therapies at the investigator's discretion).
16074380|NCT02350699|Device|Nautilus BrainPulse|A noninvasive device to detect concussion utilizing headset and sensors
16074381|NCT02350686|Drug|capecitabine|XELOX every 3 weeks will be continued until disease progression, patients' refusal or upto 8 cycles
16074382|NCT02350686|Drug|oxaliplatin|XELOX every 3 weeks will be continued until disease progression, patients' refusal or upto 8 cycles
16074383|NCT02350673|Drug|Atezolizumab|Participants will receive atezolizumab IV infusion at doses of 800 mg q2w or 1200 mg q3w.
16074384|NCT02350673|Drug|Cergutuzumab Amunaleukin|Participants will receive cergutuzumab amunaleukin IV infusion at escalated doses and at different dosing schedules in Part I and at MTD (or recommended dose) in Part II.
16074385|NCT02350660|Dietary Supplement|cow's milk|daily consumption of cow's milk
16074386|NCT02350660|Dietary Supplement|peanut powder|peanut oral immunotherapy
16074387|NCT02350647|Device|Suture Anchor HEALOCOIL|Rotator cuff tears will be repaired intraoperatively using suture anchors
16074388|NCT02350647|Device|Suture anchor Twinfix Ultra HA|
16074389|NCT02350634|Drug|18F-AV-1451|Subjects will receive a single IV bolus injection of 370 megabecquerel (MBq)(10 millicurie [mCi]) of 18F-AV-1451.
16074390|NCT02350621|Procedure|ACDF|
16074391|NCT02350621|Procedure|minimal invasive Posterior Cervical Foraminotomy|
16074392|NCT02350608|Device|Noninvasive monitor|A novel technique on noninvasive blood pressure monitoring.
16074393|NCT02350595|Other|Lean fish|
16074394|NCT02350595|Other|Fatty fish|
16074395|NCT02350582|Device|Telerehabilitation eCUIDATE system|Resistence and endurance exercise adapted to individual requeriment during chemotherapy
16074396|NCT02350569|Drug|LDV/SOF|90/400 mg FDC tablet administered orally
16074397|NCT02350556|Other|Dynamic Avoidance Task|
16074398|NCT02350556|Procedure|physical therapy|
16074399|NCT02350556|Device|3D motion on optoelectronic device|
16074400|NCT02350543|Drug|Aspirin|
16074401|NCT02350530|Drug|FOLFOXIRI + Bevacizumab|Bevacizumab 5mg/kg + irinotecan* 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle until PD or resectability or to max. 12 cycles
16074402|NCT02350530|Drug|FOLFOXIRI|Irinotecan* 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle until PD or resectability or to max. 12 cycles
16074403|NCT02350517|Drug|Paclitaxel+Nedaplatin+Endostar|Patients will receive chemotherapy every 3 weeks: Paclitaxel 175mg/m2 IV over 3 hours on Day 4; Nedaplatin 80mg/m2 IV over 1 hours on Day 4; Endostar 3mg/day for 14 days continuous infusion from Day 1 to Day 14
16074404|NCT02350504|Behavioral|Full interactive instruction|This is a prospective randomized controlled trial in which the level of the child's exposure to instruction is controlled according to the group he is attributed to. The children are divided randomly, each Sunday (the day there is an available anesthesia staff) we change the extent of the instruction. In the intervention group, we use Full interactive instruction- which include an instructional booklet, a movie and a simulator's practice.
16074405|NCT02350491|Other|Collection of biological samples|collection of biologic samples ( blood and urine) befor and after woman pregnacy
16074406|NCT02350478|Drug|Linagliptin|The subject will receive Linagliptin 5mg orally once daily for 12 weeks.
16074407|NCT02350478|Drug|Placebo|The subject will receive placebo orally once daily for 12 weeks.
16074408|NCT02350465|Behavioral|Eccentric Exercise|Submaximal progressive resistance exercise (PRE) using eccentric muscle actions for the knee extensors/flexors will be performed for 10 repetitions, 3 to 4 sets, twice per week for 12 weeks.
16074409|NCT02350465|Behavioral|Concentric Exercise|Submaximal progressive resistance exercise (PRE) using concentric muscle actions for the knee extensors/flexors will be performed for 10 repetitions, 3 to 4 sets, twice per week for 12 weeks.
16074410|NCT02350452|Procedure|Diode laser coagulation|Diode laser coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy
16074411|NCT02350452|Procedure|Bipolar coagulation|Bipolar coagulation of inner lining of ovarian endometrioma after laparoscopic cystectomy
16074412|NCT02350439|Drug|Adenosine infusion at 200μg/Kg/min|Assessment of fractional flow reserve (FFR) under high adenosine intravenous infusion dose (200mg/kg/min)
16074413|NCT02350426|Other|Gadobutrol|Gadobutrol is a solution for intravenous (IV) injection in prefilled syringe/cartridge with a unit dose strength of 1.0 millimole (mmol)/mL solution, and will be administered at up to 0.1mmol/kg.
16074414|NCT02350426|Other|18F-FDG|18F-FDG is a solution for IV injection in multidose vial, maximum 10 mL with unit dose strength of 160 megabecquerel (MBq) at maximum.
16074415|NCT02350426|Other|18F-GE-180|18F-GE-180 solution for IV injection in 10mL glass vial. Patients will receive a maximum activity of 195 MBq in a maximum volume of 10 mL (bolus) of 18F-GE-180, containing not more than 2 microgram (mcg)/mL 18F-GE-180 (20 mcg for a 10 mL dose).
16074416|NCT02350413|Other|The Endometriosis Health Profile EPH-30|Self-reported questionnaires
16074417|NCT02350400|Device|DEBIRI|DEBIRI TACE
16074418|NCT02350387|Procedure|High Intensity Short Duration Exercise|Participants randomized to this group will perform 4 sets of 8-15 repetitions of eccentric exercise using the Eccentron set at 50-80% of the participant's one repetition maximum.
16074419|NCT02350387|Procedure|Low intensity Long Duration Exercise|Participants randomized to this group will perform 5-20 minutes of continuous eccentric exercise using the Eccentron set at 50% of the participant's one repetition maximum.
16074420|NCT02350374|Other|carbohydrate counting|"patients must fill their logbook with the following data:
~cho amount at breakfast, lunch, snack and dinner
~insulin amount at breakfast, lunch, snack and dinner"
16074421|NCT02350361|Drug|Recombinant human endostatin|Recombinant human endostatin 7.5mg/m2
16074422|NCT02350361|Drug|Placebo|Placebo
16074423|NCT02350335|Drug|Nicotine (transdermal)|Application of transdermal nicotine replacement in smokers with acute aneurysmal hemorrhage
16074424|NCT02350322|Other|Schoolmeal with fatty fish|Schoolmeal with fatty fish three times a week for 12 weeks
16074425|NCT02350322|Other|Schoolmeal without fish|Schoolmeal with meat/cheese three times a week for 12 weeks
16074426|NCT02350322|Dietary Supplement|Supplement|Omega-3 capsules three times a week for 12 weeks
16074427|NCT02350309|Drug|Lemborexant 5 mg|Lemborexant 5 mg tablet.
16074428|NCT02350309|Drug|Lemborexant 10 mg|Lemborexant 10 mg tablet.
16074429|NCT02350309|Drug|Lemborexant-matched placebo.|Lemborexant-matched placebo tablet.
16074430|NCT02350309|Drug|Flurazepam 30 mg|Flurazepam 30 mg capsule.
16074431|NCT02350296|Drug|KSL 40 mg|Ketoprofen lysine salt oral immediate release tablets 40 mg
16074432|NCT02350296|Drug|OKi® 80 mg|Ketoprofen lysine salt granules for oral solution 40 mg (half of a bipartite sachet)
16074433|NCT02350283|Device|Interventional treatment with Solitaire|Patients will be treated for mechanical recanalization with Solitaire within 12 hours after stroke onset plus standard medical management.
16074434|NCT02350270|Other|gait and cognitive testing|
16074435|NCT02350257|Behavioral|Internet-based CBT|12 weeks of internet-based CBT
16074436|NCT02350244|Behavioral|Computer program|Intervention consists in a computer program suggesting workers to take active breaks at given times of their working day, during one month.
16074437|NCT02350231|Drug|The progesterone vaginal pessary|Those patients will receive progesterone vaginal pessary for prevention of preterm delivery in twins pregnancy
16074438|NCT02350231|Drug|Tonics group|Those patients will receive only tonics
16074439|NCT02350218|Drug|Eglandin|Inject Eglandin 360㎍ or 720㎍ for 14 days in living donor liver transplanted patient
16074440|NCT02350205|Biological|Self assembled skin substitute (SASS)|Two site A / B, an area of about 50-100 cm2 are selected. The two sites are side by side and subjected to similar stresses. The type of graft (split thickness autograft or SASS) for the site A or B has been determined in advance.
16074441|NCT02350205|Procedure|Split-thickness autograft|Two site A / B, an area of about 50-100 cm2 are selected. The two sites are side by side and subjected to similar stresses. The type of graft (split thickness autograft or SASS) for the site A or B has been determined in advance.
16074442|NCT02350192|Behavioral|e-health educational intervention (eHEI)|The e-HEI link (e-health link http://ehealth.nur.cuhk.edu.hk) provides the content of culture-specific cognitive knowledge related to CVD and measures to modify risk factors. The member area and interactive platform of the e-HEI website allows the self-monitoring of individual health and exercise records. Members can view and retrieve their own exercise records daily, and health measures trend regularly.
16074443|NCT02350179|Drug|Tranexamic Acid|"This will be a prospective, randomized controlled trial that will be carried at Obstetrics and Gynecology Department, Ain Shams Maternity Hospital.
~The study will include 100 pregnant women with singleton fetus 38 or more weeks gestation who will be divided in to two groups.
~Study group will include 50 women and control group will include 50 women. Women assigned to the study group will receive 1 gr of TXA injection (Kapron, AMOUN Pharmaceutical co.) given slowly I.V over 10 minutes before the operation.
~The control group will receive 30ml of 5% glucose. Both provider and patient will be double-blinded until the conclusion of the study."
16074444|NCT02350179|Drug|Glucose|The control group will receive 30ml of 5% glucose. Both provider and patient will be double-blinded until the conclusion of the study.
16074445|NCT02350166|Procedure|laparoscopic surgery|laparoscopic-assisted small-incision surgery
16074566|NCT02349204|Behavioral|Music - Mozart's sonata for 2 pianos in D-440|
16074446|NCT02350140|Other|Text messaging from beginning|"Registered women will then receive up to 14 text messages as follows: weeks 28, 30, 32, 34, 36, 38, 39, and 40 during the third trimester of pregnancy; weeks 1, 2, 3, 4, 5, and 6 after delivery.Participants at facilities receiving TextIT will have the option to call or send text messages to a designated clinic phone, to which a clinic nurse will respond. Participants will also have an option to request a call from the clinic by sending a free call back text message to the designated clinic phone at any time."
16074447|NCT02350140|Other|Text messaging after 6 months of control|After six months of standard care, women at control clinics will be registered to receive the text messaging intervention with up to 14 text messages as follows: weeks 28, 30, 32, 34, 36, 38, 39, and 40 during the third trimester of pregnancy; weeks 1, 2, 3, 4, 5, and 6 after delivery.
16074448|NCT02350127|Behavioral|Preventing Loss of Independence through Exercise (PLIE)|PLIE is an integrative group movement program that focuses on training procedural memory for the ability to perform the movements that are most needed for daily function (e.g., transitioning safely between sitting and standing) while increasing mindful body awareness and encouraging social connection. It combines elements from a wide range of Eastern and Western exercise modalities, including occupational therapy, physical therapy, yoga, tai chi, Feldenkrais, Rosen Method, dance movement therapy and mindfulness meditation.
16074449|NCT02350127|Behavioral|Usual Care|Usual care activities will vary between participants. Some will be attending the adult day center and may be engaging in structured physical, mental and/or social activities. Other participants will be living in the community and may engage in physical, mental, and/or social activities on their own or with a caregiver.
16074450|NCT02350114|Procedure|6 Minute Walk Test|Evaluation of walking distance on standardized 6 minute walk test
16074451|NCT02350101|Device|Rotational thromboelastometry|In bleeding patients point of care measurements are performed, in this case Rotational Thromboelastometry (ROTEM) to guide the use of blood products and coagulation factors.
16074452|NCT02350088|Drug|probiotics|probiotics
16074453|NCT02350088|Drug|placebo|placebo
16074454|NCT02350075|Procedure|Dental implants installation|Dental implants installation is a procedure to insert dental implants into alveolar bone.
16074455|NCT02350075|Device|Osteotome Sinus floor elevation|Osteotomes with different diameters are specially-designed device to vertically increase the bone volume in atrophic maxilla.
16074456|NCT02350036|Other|ultrasound monitoring|Uterine artery Doppler assessment
16074457|NCT02350023|Drug|Topical latanoprost 0.005%|Local application of the drug on affected skin/scalp
16074458|NCT02350023|Drug|Topical betamethasone 0.05%|Local application of the drug on affected skin/scalp
16074459|NCT02350010|Device|CT Angiography|"CTA Scan with the specified sequences below:
~120 kVp, 360 mAs, 0.5 second/rotation, 0.75 mm thick with a pitch of 0.65. Coronal and sagittal multiplanar reconstructed images with 10.0-mm-thick images spaced by 3 mm.
~Axial reformed images were 4 mm thick with 2-mm spacing. 90 mL of nonionic iodinated contrast (OPTIRAY 350) at 5 mL/s."
16074460|NCT02349997|Other|no interventions|This is an observational study and no intervention applied.
16074461|NCT02349971|Device|MR-HIFU|Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU) provides precise and controlled delivery of focused ultrasound energy inside a lesion using an external applicator, without the need for a scalpel or needle
16074462|NCT02349958|Device|HIPEC: MMC 30mg @ T0, 10mg @ T45min|MMC 30mg @ T0, 10mg @ T45min for Appendix, Psuedomyxoma, colorectal, small bowel
16074463|NCT02349958|Device|HIPEC: MMC + CDDP 30mg @ T0, 10mg @ T45min 50 mg/m2 @T0|Gastric and Pancreato-biliary HIPEC: MMC + CDDP 30mg @ T0, 10mg @ T45min
16074464|NCT02349958|Device|HIPEC: CDDP 75 mg/m2 @T0|Ovarian/peritoneal/fallopian tube, Uterine CDDP 75 mg/m2 @T0
16074465|NCT02349958|Device|HIPEC: CDDP+ Doxorubicin 50 mg/m2 @T0 15 mg/m2 @T0|CDDP+ Doxorubicin 50 mg/m2 @T0 15 mg/m2 @T0 Mesothelioma and Sarcoma
16074466|NCT02349945|Drug|follitropin alpha|"All subjects included in the study will receive recombinant FSH therapy (follitropin alpha: Gonal-f 150 I.U. s.c. every other day for 12 weeks). Follow up: 12 further weeks after end of treatment.
~Previous studies included in the Cochrane meta-analysis used: hMG/hCG, 150 IU three times a week for 13 weeks; purified FSH, 150 IU/day for 12 weeks; rec hFSH, 150 IU/day for 12 weeks; rec hFSH, 100 IU on alternate days for 3 months. Therefore any dosage > 100 IU on alternate days is eligible. The duration of treatment is based on the duration of one spermatogenetic cycle."
16074467|NCT02349932|Other|Healthy Adults|The following samples will be collected: fecal, blood, and saliva. The samples will be tested for HBGA-reactive antigens using an immunoaffinity assay.
16074468|NCT02349919|Drug|Procaterol|Procaterol 25 micrograms/tablet, 1 tablet twice daily for 4 weeks
16074469|NCT02349919|Drug|Placebo|Placebo twice daily for 4 weeks
16074470|NCT02349906|Drug|Treosulfan|
16074471|NCT02349906|Drug|Busilvex|
16074472|NCT02349893|Device|RFA treatment|RFA treatment using CelonProSleep plus system
16074473|NCT02349880|Behavioral|shared decision making training|
16074567|NCT02349191|Procedure|Omental transposition for mild Alzheimers disease|An omental pedicle is brought from the abdomen underneath the skin and sewn to the dura matter of the brain via a craniotomy.
16074568|NCT02349178|Drug|Clofarabine|Days 1-5 receive Clofarabine 20 mg/m2 IV over 2 hours
16074481|NCT02349854|Procedure|Biopsy|1 scalp biopsy will be done at the site of central sensitization testing, according to standard of care practices. First, the site will be anesthetized and within this area, 2 immediately adjacent (ie contiguous) punch biopsies will be taken-2mm & 3mm. Both will be closed simultaneously using either (i) non fast-absorbing gut sutures, requiring a 10-14 day follow-up visit for suture removal; (ii) fast absorbing gut sutures that will not require a subsequent suture removal visit, or (iii) gel foam without stitches that also does not require a suture removal visit. Wound care instruction will be discussed with patient. The patient will be instructed to apply petroleum jelly at least 3 times per day to the biopsy site, reflecting standard of care clinical care at BMC.
16074482|NCT02349841|Drug|Meropenem|To administer 2g daily 8 hourly for 14 days
16074483|NCT02349841|Drug|Faropenem|To adminster 600mg 8 hourly daily for 14 days
16074484|NCT02349841|Drug|Amoxycillin/clavulanic acid|To administer 625mg 8 hourly daily for 14 days together with the faropenem and meropenem
16074485|NCT02349841|Drug|Rifafour e275|To be taken as per the National TB treatment programme for 14 days
16074486|NCT02349828|Drug|Acyclovir|
16074487|NCT02349815|Drug|Levonorgestrel (Jaydess, Skyla, BAY86-5028)|Women use Levonorgestrel (Jaydess, BAY86-5028) .
16074488|NCT02349802|Drug|Auto-injector with exenatide suspension|A flexible study design to accommodate multiple cohorts.
16074489|NCT02349802|Drug|Syringe with exenatide suspension|A flexible study design to accommodate multiple cohorts.
16074490|NCT02349776|Other|Providing testimonies from survivors of transplants to patients|"Patients will be asked to complete one mood measure (the HADS), the Life Orientation Test (LOT), and a questionnaire about expectations of treatment in clinic once a decision to proceed to transplant has been made.
~Patients will receive the testimonies upon admittance to the transplant unit and then receive the HADS and a structured interview within the first week of being admitted to the transplant ward (just prior to receiving the transplant) and within the first two weeks following the transplant."
16074491|NCT02349763|Drug|Intravenous Dexamethasone|Lactose (Placebo) 5 tablets given orally at 12 and 6 hours before paclitaxel infusion and dexamethasone 20 mg (5mg/ml) given intravenously at 30 minutes before paclitaxel infusion
16074492|NCT02349763|Drug|Oral Dexamethasone|Dexamethasone 20 mg (4 mg/tablet) or 5 tablets given orally at 12 and 6 hours before paclitaxel infusion and 0.9% NaCL (Placebo) 4 ml given intravenously at 30 minutes before paclitaxel infusion
16074493|NCT02349750|Procedure|endometrial scratch injury|ESI using No.8 neonatal feeding tube
16074494|NCT02349737|Other|Exposure to BIA interference with the ICD|Exposure to BIA interference with the ICD
16074495|NCT02349724|Biological|Anti-CEA-CAR T|T cells modified with CEA targeted chimeric antigen receptor.
16074496|NCT02349711|Dietary Supplement|Probiotic mixture|A 350 mg capsule containing a mixture of Lactobacillus gasseri, Bifidobacterium bifidum, and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration) will be taken twice daily for 8 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). Inactive ingredients include gelatin, potato starch, and silica.
16074497|NCT02349711|Dietary Supplement|Placebo|Placebo will be taken as a capsule twice daily for 8 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded). Supplement contains 348.25 mg of potato starch.
16074498|NCT02349698|Biological|Chimeric Antigen Receptor Modified T cells Targeting CD19|T cells modified with CD19 targeted chimeric antigen receptor.
16074499|NCT02349685|Procedure|H. pylori culture and antimicrobial susceptibility test|Antral and body biopsy specimens were evaluated separately. Organisms were identified as H. pylori by Gram staining, colony morphology, and positive oxidase, catalase, and urease reactions. Minimum inhibitory concentrations (MICs) were determined by the agar dilution method. Amoxicillin (Sigma Chemical Co., St. Louis, Mo.), clarithromycin (Abbott Laboratories, Abbott Park, Ill.), metronidazole (Sigma), tetracycline (Sigma) and moxifloxacin (Sigma) for the H. pylori isolates were examined by use of the serial twofold agar dilution method and the reference of susceptibility testing was according to the recommendations of the Clinical and Laboratory Standards Institute [amoxicillin (AMC), MIC ≥ 0.5 μg / ml; clarithromycin (CLA), MIC > 1.0 μ g / ml; metronidazole (MET), MIC > 8 μ g / ml; tetracycline (TC), MIC > 4 μ g / ml; and moxifloxacin (MOX), MIC > 1 μ g / ml).
16074500|NCT02349685|Drug|14 day PBMT group|Rescue therapy using 14 day PBMT regimen [Proton pump inhibitor (PPI) regular dose b.i.d., tripotassium dicitrate bismuthate 300 mg q.i.d. (three tablets at 30 min before meals and one tablet at 2 hours after dinner), metronidazole 500 mg t.i.d., and tetracycline 500 mg q.i.d]
16074501|NCT02349685|Drug|14 day MEA group|Rescue therapy using 14 day MEA regimen (PPI regular dose b.i.d., moxifloxacin 400 mg q.d., and amoxicillin 1g b.i.d.)
16074502|NCT02349672|Procedure|blood sample|Blood will be collected to test for concentrations of UCH-L1 and GFAP.
16074503|NCT02349659|Device|Implantation with the commercially available Axium neurostimulator|
16074504|NCT02349646|Device|Implantation with the commercially available Axium neurostimulator|
16074505|NCT02349633|Drug|PF-06747775|
16074506|NCT02349633|Drug|Palbociclib|
16074507|NCT02349633|Drug|Avelumab|
16074508|NCT02349620|Biological|PRF|implant stability was measured by RFA and implant resorption was measured by IOPA after surface treatment by PRF
16074509|NCT02349607|Drug|PF-05089771 300mg|PF-05089771 300 mg
16074510|NCT02349607|Drug|PF-05089771 300 mg + pregabalin 300 mg|PF-05089771 300 mg + pregabalin 300 mg
16074511|NCT02349607|Drug|Placebo|Placeco
16074512|NCT02349607|Drug|pregabalin 300 mg|pregabalin 300 mg
16074513|NCT02349607|Drug|ibuprofen 600 mg|ibuprofen 600 mg
16074514|NCT02349594|Drug|Omegaven 10%|intravenous administration 10% (w/v) fish oil emulsion (Omegaven) for 1 hour on three consecutive days at a dose of 0.2 g/kg bodyweight/hr.
16074515|NCT02349594|Drug|Intralipid 20%|intravenous administration of 20% (w/v) lipid-control (Intralipid®), for 1 hour on three consecutive days at a dose of 0.2 g/kg bodyweight/hr.
16074516|NCT02349581|Procedure|PECS block|Ultrasound guided delivery of local anesthetic between the pectoral muscles
16074517|NCT02349581|Drug|Bupivacaine|
16074569|NCT02349178|Drug|Cyclophosphamide|Days 1-5 receive Cyclophosphamide 300 mg/m2 IV as a 30-60 minute infusion
16074570|NCT02349178|Drug|Etoposide|Days 1-5 receive Etoposide 100 mg/m2 IV over 2 hours
16074571|NCT02349165|Procedure|Transepithelial versus epithelium-off CXL|A comparison of the CXL procedure with and without epithelium removal
16074518|NCT02349568|Procedure|High risk group|Patients with high risk underwent EUS examination under conscious sedation. EUS was examined from second part of duodenum up to duodenal bulb. All patients even if negative EUS examination of CBD stone were underwent ERCP in the same session. The ERCPs were performed in standard manner. All patients were contacted by phone on day 1, 3 and 30 after the procedure.
16074519|NCT02349568|Procedure|Intermediate risk group|Patients with intermediate risk underwent EUS examination under conscious sedation. EUS was examined from second part of duodenum up to duodenal bulb. ERCPs were done at the discretion of the attending physicians. The ERCPs were performed in standard manner. The patients without ERCP done were contacted at 3 months interval to assess symptoms and LFT for 12 months.
16074520|NCT02349555|Dietary Supplement|Nutritional Supplement Blend|It is to be taken orally at a dose of 4 capsules per day, 2 capsules with breakfast and 2 capsules with dinner.
16074521|NCT02349542|Drug|Liposomal bupivacaine|One (1) 20 mL vial of 266 mg liposomal bupivacaine (3% (~8mg free bupivacaine)) will be injected into each surgical (knee) site following simultaneous bilateral total knee arthroplasty. In addition, 30 mL of 0.25% bupivacaine (75 mg free bupivacaine) will be injected into each surgical (knee) site for a total of 83 mg free bupivacaine injected into each surgical (knee) site.
16074522|NCT02349529|Behavioral|Psychosocial Intervention Group|6 group sessions
16074523|NCT02349529|Other|Waiting list control|Treatment as usual
16074524|NCT02349516|Drug|Squalamine Lactate Ophthalmic Solution 0.2%|Squalamine Lactate Ophthalmic Solution 0.2% eye drop to be administered to study eye either BID or QID for 52 weeks
16074525|NCT02349503|Drug|NBI-77860|
16074526|NCT02349503|Drug|NBI-77860|
16074527|NCT02349503|Drug|NBI-77860|
16074528|NCT02349490|Device|Seraseal / Fastact Hemostatic agent (combined activated factors IIa, VIIa, IXa, Xa )|Following endoscopic confirmation of a bleeding, 2,5-5ml of liquid Seraseal / Fastact, is topically applied to the bleeding site via catheter
16074529|NCT02349477|Drug|Gabapentin|gaba potentiating medication
16074530|NCT02349477|Drug|Placebo|a pill that looks exactly like the active medication but does not contain medication
16074531|NCT02349464|Other|Specialized Preterm Infant/Mother Dyad Lactation Support|Mother will receive home equipment and pediatric clinic lactation support.
16074532|NCT02349451|Biological|adalimumab|
16074533|NCT02349451|Biological|ABT-122|
16074534|NCT02349438|Device|senofilcon A|A soft spherical contact lens
16074535|NCT02349438|Device|lotrafilcon B|
16074536|NCT02349425|Drug|Gefapixant|Gefapixant 7.5 and 50mg tablets administered orally
16074537|NCT02349425|Drug|Placebo (for gefapixant)|Placebo to gefapixant 7.5 and 50mg tablets administered orally
16074538|NCT02349412|Other|Early palliative care|
16074539|NCT02349399|Drug|Cyproterone / Ethinylestradiol (Diane-35, BAY86-5264) and its Generics|Hormonal Contraceptive: Cyproterone Acetate 2 mg / Ethinylestradiol 35 μg
16074540|NCT02349386|Drug|BHR-200 (0.36% transdermal 17β-estradiol gel)|An absorptive hydroalcoholic gel preparation containing 17β-estradiol.
16074541|NCT02349386|Drug|Placebo|An absorptive hydroalcoholic gel preparation gel of the same ingredients as BHR-200, but without 17β-estradiol.
16074542|NCT02349373|Behavioral|An 8 week preconditioning period|Receipt of a weekly running schedule through an online training diary.
16074543|NCT02349373|Behavioral|16 week training period|Receipt of a weekly running schedule through an online training diary.
16074544|NCT02349360|Biological|L. johnsonii N6.2|L. johnsonii N6.2 10^10 CFU in capsule form administered for 8 weeks
16074545|NCT02349360|Biological|Placebo|Encapsulated starch placebo administered for 8 weeks
16074546|NCT02349334|Device|Percutaneous Tibial Nerve Stimulation|
16074547|NCT02349321|Behavioral|Skhokho Supporting Success for Schools|All information describing each facet of the intervention are included in the arm/group descriptions.
16074548|NCT02349321|Behavioral|Skhokho Supporting Success for Families|All information describing each facet of the intervention are included in the arm/group descriptions.
16074549|NCT02349308|Device|CentrosFLO Long Term Hemodialysis Catheter|
16074550|NCT02349295|Drug|Placebo|Administered SC
16074551|NCT02349295|Drug|Ixekizumab 80 mg Q4W|Administered SC
16074552|NCT02349295|Drug|Ixekizumab 80 mg Q2W|Administered SC
16074553|NCT02349282|Dietary Supplement|Calcifediol 10ug/day|
16074554|NCT02349282|Dietary Supplement|Vitamin D3 20ug/day|
16074555|NCT02349282|Dietary Supplement|Placebo|
16074556|NCT02349243|Drug|Entacapone|200 mg entacapone, oral intake, 4 times per day (after breakfast, lunch, supper and before sleep at night), for 6 six months
16074557|NCT02349243|Drug|Placebo|200 mg placebo, oral intake, 4 times per day (after breakfast, lunch, supper and before sleep at night), for 6 six months
16074558|NCT02349230|Other|Astym treatment|Astym is a manual therapy technique applied by a certified therapist with advanced training in the technique. The technique is applied to a limb or body segment with specialized instruments in a specific sequential protocol that incorporates the muscle groups and joints of the entire kinetic chain.
16074559|NCT02349217|Behavioral|Mindfulness-Based Relationship Enhancement (MBRE)|Participant and partner take part in an 8-week Mindfulness-Based Relationship Enhancement (MBRE) intervention course. MBRE course consists of meditation and yoga techniques and handouts.
16074560|NCT02349217|Behavioral|Self-Help Materials|Participants and partner receive self-help materials.
16074561|NCT02349217|Behavioral|Pain Assessment|Pain assessment administered at baseline and at follow up visit. Pain assessment involves submerging hand in cold water.
16074562|NCT02349217|Behavioral|Questionnaires|Questionnaires completed at baseline and at follow up visit. Questionnaires ask about fatigue, mood, stress, social support, marital satisfaction, depression, and general demographics (age, race and so on). It should take about 1½ hours total to complete the questionnaires.
16074563|NCT02349217|Behavioral|Neurocognitive Tests|Neurocognitive tests administered at baseline and at follow up visit. Tests to check memory and thinking abilities.
16074564|NCT02349217|Procedure|Cortisol Tests|Cortisol testing performed after baseline visit and at follow up visit. Participants asked to collect saliva samples for cortisol assays immediately, 30, 45, and 60 minutes after awakening (representing the cortisol awakening response) and at noon, 4 P.M. and 8 P.M.
16074565|NCT02349217|Behavioral|Interviews|Interviews conducted after follow up visit. These interviews are audio-taped and transcribed.
16074572|NCT02349165|Drug|Ricrolin TE|Ricrolin TE was instilled during 30 minutes before ultraviolet-A irradiation
16074573|NCT02349165|Drug|Isotonic riboflavin|After epithelium removal, isotonic riboflavin was instilled during 30 minutes before ultraviolet-A irradiation
16074574|NCT02349152|Drug|Remifentanil|Subjects in the experimental group will receive remifentanil infusion 0.1-0.4ug/kg/minute before induction of anesthesia and continued until skin closure. During cardiopulmonary bypass, remifentanil infusion will be increased to 0.5-1 ug/kg/min as hemodynamically tolerated.
16074575|NCT02349152|Drug|Fentanyl|Subjects in the control group will initially receive intermittent boluses of Fentanyl in the range of 50-250 ug. Additional fentanyl can be given titrated to hemodynamic parameters throughout surgery.
16074576|NCT02349139|Drug|ASN001: Escalating dose Part A|Androgen inhibitor
16074577|NCT02349126|Drug|ARC-520 Injection|ARC-520 Injection is a liver-targeted antiviral therapeutic designed to treat chronic hepatitis B virus (HBV) infection via an RNA interference (RNAi) mechanism.
16074578|NCT02349113|Drug|Estrogens (Climara)|Treatment with estrogens: Estradiol dermal patch 0.1mg/d transdermally
16074579|NCT02349100|Device|Nellix Endoprosthesis|Implantation of Nellix
16074580|NCT02349087|Device|Acute EEG with fast applicable EEG electrode|
16074581|NCT02349074|Procedure|Digestive endoscopy|Performed a systematic œsophago-gastro-duodenoscopy between 2 and 4 days after out-of-hospital cardiac arrest
16074582|NCT02349061|Drug|Ustekinumab IV|Weight-range based dosing of approximately 6 mg/kg of ustekinumab intravenously at Week 0.
16074583|NCT02349061|Drug|Placebo Infusion|Placebo intravenously at Week 0.
16074584|NCT02349061|Drug|Placebo SC|Placebo subcutaneously at Weeks 8 and 16.
16074585|NCT02349061|Drug|Ustekinumab SC|Ustekinumab 90 mg subcutaneously every 8 weeks up to Week 40 and up to Week 104 in study extension (for eligible participants)
16074586|NCT02349061|Other|Concomitant Medication|Concomitant treatment (mycophenolate, azathioprine/6-mercaptopurine, methotrexate, hydroxychloroquine and/or chloroquine, oral corticosteroids, NSAIDs, antihypertensive medications, and topical medications) through Week 48, as well as through the study extension although tapering of corticosteroids is encouraged beyond Week 48.
16074587|NCT02349048|Drug|Simeprevir 150 mg|Simeprevir 150 mg capsule orally once daily.
16074588|NCT02349048|Drug|Daclatasvir 60 mg|Daclatasvir 60 mg tablet orally once daily.
16074589|NCT02349048|Drug|Sofosbuvir 400 mg|Sofosbuvir 400 mg tablet orally once daily.
16074590|NCT02349035|Device|Compare control of multifunction transradial prosthesis|Subjects practice control methods using a VR system. EMG data and virtual games are used and provide data to assess control methods without prosthesis. Subjects are fit with commercially available multifunctional hand system. They receive 1-3 days of training for conventional or pattern recognition control. They return home for an 8 week trial. They use the prosthesis for 2 hours a day across the 8 week trial. They keep a log of use and check with a therapist about usage and performance. After the 8 week trial, data from the prosthesis is downloaded. The subject will complete 1-3 days of outcomes testing. They perform a series of tests and data is recorded. The subject will repeat the 1-3 days of training, 8 week home trial, and 1-3 days of outcomes testing with either type of control.
16074591|NCT02349035|Procedure|Perform TMR surgery and evaluate transradial TMR pattern recognition control of multifunctional prostheses.|Subject has Targeted Muscle Reinnervation surgery. The surgery transfers median nerve to flexor digitorum superficialis muscle and ulnar nerve to flexor carpi ulnaris muscle. Two weeks after surgery, exercises start for muscle recovery. Then return to prosthesis from Phase 1 for 6 months. If they have pattern recognition control, usage and performance will be tracked for 6 months. If they return to conventional control, they will not complete tests, track usage, or performance. Six months after surgery, they return to pattern recognition control. Receive 1-3 days of training. Take prosthesis home for 8 week trial. Log use of device, note issues, and follow up with therapist. After home trial, 1-3 days of outcomes testing are completed and usage data downloaded. Continue using their prostheses for an additional 3-4 months. At 12 months after surgery, a final round of 1-3 days of testing and data are downloaded.
16074592|NCT02349022|Radiation|[89Zr]Df-IAB2M|
16074593|NCT02349009|Drug|C-82 Topical Gel, 1%|active
16074594|NCT02349009|Drug|C-82 Topical Gel, Placebo|placebo
16074595|NCT02348996|Other|Bioimpedance|status of overhydration determine by BCM once a week to determine dry weight
16074596|NCT02348996|Other|Clinical evaluation|Doctors or nurses will evaluate patients on a daily basis and determine dry weight
16074597|NCT02348983|Behavioral|Health Coaching via Telephone|Health coaching arm to assess feasibility of intervention among truck driving population. Coaching will be weekly with emphasis on both diet and physical activity. No medication or treatment devices are administered.
16074598|NCT02348970|Device|ONIRIS®|sleeping test
16074599|NCT02348970|Device|TALI|sleeping test
16074600|NCT02348944|Other|serum and urine sample|Serum and urine samples will be collected at baseline, weeks2, 16, 52 and 68 to assess intra-individual biological variability of cartilage-specific biomarkers Coll2-1/Coll2-1NO2 / FIB3-1 and FIB3-2.
16074601|NCT02348931|Device|Use of customized nasal brace (Nasella) for nose deformities|
16074602|NCT02348931|Procedure|corrective surgery|
16074603|NCT02348918|Drug|Luminate 1.0mg|
16074604|NCT02348918|Drug|Luminate 2.0mg|
16074605|NCT02348918|Drug|Luminate 3.0mg|
16074606|NCT02348918|Drug|Avastin|
16074607|NCT02348918|Drug|Luminate 0.5mg|
16074608|NCT02348905|Drug|ACTHAR Gel 40 units twice weekly|ACTHAR Gel (adrenocorticotropic hormone) 40 units twice weekly between Baseline and week 12.
16074609|NCT02348905|Drug|ACTHAR Gel 80 units twice weekly.|ACTHAR Gel (adrenocorticotropic hormone) 80 units twice weekly between Baseline and week 12.
16074610|NCT02348892|Other|Coordinator|Patients in complex situation taken care by coordinator
16074611|NCT02348892|Other|Classic plan|Patients in complex situation taken care by classic plan
16074612|NCT02348879|Drug|AMG 403|AMG 403 is for treatment of subjects with chronic pain
16074613|NCT02348879|Drug|Placebo|contains no active drug
16074614|NCT02348866|Other|method of laundering and donning scrubs|
16074615|NCT02348853|Behavioral|Healthy Weight for Living (HWL)|
16074616|NCT02348853|Behavioral|Current Best Practice (CBP)|
16074659|NCT02348489|Drug|SGI-110 (guadecitabine)|Investigational medicinal product
16074617|NCT02348840|Device|mHealth|A cell phone that can capture data measurements from devices on blood pressure, oxygen level, the heart rate of pregnant women, and the heart rate of the baby.
16074618|NCT02348827|Behavioral|Family psychoeducation|
16074619|NCT02348827|Behavioral|Social support group|
16074620|NCT02348801|Behavioral|Weight loss and Exercise|"Group behavior therapy sessions designed to acquire positive weight-control skills and attitudes, and practice weight-maintenance skills. A balanced diet will be prescribed to provide a deficit of 500-750 kcal/day from daily energy requirement.
~Exercise sessions of ~90 min duration 15 min warm-up of flexibility exercise, followed by ~30 min of aerobic exercise, and, after a brief rest period, ~30 min of resistance training, and finally ~15 min balance exercise) conducted three times weekly supervised at our exercise facility for first six months, and regular exercises continued at community-fitness centers and at home for the following six months."
16074621|NCT02348801|Behavioral|Healthy lifestyle|Diabetes support and education
16074622|NCT02348788|Drug|Artemether-lumefantrine + Primaquine|
16074623|NCT02348788|Drug|Chloroquine + Primaquine|
16074624|NCT02348775|Dietary Supplement|GlyNAC (combination of glycine and n-acetylcysteine)|HIV patients will be studied before and after receiving GlyNAC
16074625|NCT02348762|Dietary Supplement|Cysteine (as n-acetylcysteine) and Glycine|Older subjects will be studied before and after receiving cysteine and glycine
16074626|NCT02348749|Radiation|18F-MFBG (meta-fluoro benzylguanidine)|About 8mCi of 18F-MFBG will be administered to adult patients. Pediatric dose will be based upon adjustment using BSA to the dose of 8 mCi for 1.7m2 BSA ± 10% with maximum activity of 8 mCi. The tracer will be given intravenously.
16074627|NCT02348749|Device|Positron emission tomography (PET) imaging|Dynamic imaging for the first 30 min over the chest and Whole body (WB) PET-CT scan. Imaging 2 (~1.0 - 2 hours post dose): Whole body (vertex to feet) PET-CT scan. Imaging 3 (~3-4 hours post dose): Whole body (vertex to feet) PET-CT scan.
16074628|NCT02348749|Other|Blood draws|Blood samples to be collected: at baseline, 5, 15, 30, 60, 90, 120 and 180 mins post injection on the day of administration. (Phase I only)
16074629|NCT02348736|Device|Time for tracheal intubation|In a randomised trial we measure the time for ventilation by means of endtidale CO2 Curve
16074630|NCT02348723|Drug|Warfarin|Patients receiving Warfarin to keep International Normalized Ratio (INR)between 2.0 - 3.0
16074631|NCT02348723|Drug|Dabigatran Etexilate 150mg|Patients receiving Dabigatran Etexilate 150mg twice daily dosing (BID)
16074632|NCT02348710|Behavioral|Exercise OE workbook|The workbook will aim to make participants aware of the breadth and depth of OEs by first providing a global overview of the many and diverse positive outcomes breast cancer survivors may experience. Participants will then be asked to focus on the three OEs they would most like to experience. Each section of the OE guide contains activities to target specific OE dimensions. Importance will be increased through elaboration of why outcomes are important to the participant; and certainty will be increased by narrative messages from other breast cancer survivors and an oncologist. Accessibility will be increased by having the participant think about the association between exercise and its outcomes
16074633|NCT02348710|Behavioral|Diet workbook|The workbook will contain the same activities as the intervention workbook but be focused on diet instead of exercise.
16074634|NCT02348697|Biological|NOVOCART 3D|Autologous Chondrocyte Implantation
16074635|NCT02348684|Radiation|Radiation therapy groups|Radiation Therapy treatment between 2000 and 2007.
16074636|NCT02348671|Other|shear- force|19 Newton shear- force and 3,9 kPa pressure for half an hour
16074637|NCT02348658|Drug|TAK-536TCH|TAK-536TCH tablets
16074638|NCT02348645|Procedure|Spinal fusion|
16074639|NCT02348645|Procedure|Spinal decompression|
16074640|NCT02348632|Drug|JZP-110|
16074641|NCT02348619|Drug|JZP-110|
16074642|NCT02348606|Drug|JZP-110|
16074643|NCT02348606|Drug|Placebo oral tablet|
16074644|NCT02348593|Drug|JZP-110|
16074645|NCT02348593|Drug|Placebo oral tablet|
16074646|NCT02348580|Behavioral|Child centered teaching of life-skills|The intervention includes five core components: (1) personal understanding and exploration, (2) rights and responsibilities, (3) savings and spending, (4) planning and budgeting, and (5) social and financial enterprise. The training and curriculum are both manualized. The curriculum is in English and is regionally specific (for Anglophone Africa) and has been contextualized for Rwanda. The minimum hours required by Aflatoun's fidelity guide is 20 hours which includes 10 hours of curriculum lesson and 10 hours of learning activities (savings groups, social and financial projects, club activities etc).
16074647|NCT02348567|Other|Unannounced hospital surveys|This is a cluster-randomised controlled trial performed at hospital level. We hypothesise that unannounced surveys produce less successful assessments of patient safety compared to announced surveys (conventional/control). This study defines less successful as less compliance with the included standards and performance indicators.
16074648|NCT02348567|Other|announced hospital surveys|
16074649|NCT02348554|Behavioral|Controlled conditions|The 13 volunteers in controlled conditions performed each of the nine activities several times according to the activity scenario: sitting, slow, normal and brisk walking, climbing and descending stairs (eight floors), standing, slow running and taking public transportation (tramway). The duration of each activity varied from 2 to 20 minutes.
16074650|NCT02348554|Behavioral|Free-living conditions|The spontaneous activities of 30 volunteers were recorded in the free-living conditions for a full day selected either during the week or the weekend.
16074651|NCT02348541|Device|CollaGUARD|
16074652|NCT02348528|Drug|Lenalidomide|
16074653|NCT02348528|Drug|Dexamethasone|
16074654|NCT02348515|Procedure|Heart failure or coronary disease|Small samples collected from the apex core in the heart. In addition, blood samples will be taken.
16074655|NCT02348515|Procedure|Heart transplant patients|Heart samples collected including, excess myocardial biopsy samples. In addition, blood samples will be taken.
16074656|NCT02348515|Procedure|Orthotopic Heart Transplant Patients|Myocardial tissue samples collected from the diseased heart. In addition, blood samples will be taken.
16074657|NCT02348515|Procedure|Heart Surgery Patients|Heart samples will be collected from the left atrial appendages. In addition, blood samples will be taken.
16074658|NCT02348515|Procedure|Blood Draw|All subjects will have 20 ml of blood drawn for further analysis.
16075917|NCT02339740|Other|Quality-of-Life Assessment|Ancillary studies
16074660|NCT02348489|Drug|Treatment Choice|Choice of one: cytarabine, decitabine, or azacitidine
16074661|NCT02348476|Other|No Intervention|No study drug is administered in this study.
16074662|NCT02348463|Drug|Clindamycin-2-phosphate|how many women will deliver before the 37th week of gestation
16074663|NCT02348450|Drug|Irinotecan|40mg
16074664|NCT02348450|Drug|Etoposide|5ml：0.1g
16074665|NCT02348450|Drug|Cisplatin|6ml：30mg
16074666|NCT02348437|Procedure|Repair|An on-going suture technique with minimum four stitches.
16074667|NCT02348437|Procedure|Non-repair|The PQ muscle will be placed so it covers the volar plate. No suture.
16074668|NCT02348424|Drug|Solithromycin|Cohorts 1 and 2 will receive a single 1000mg dose of solithromycin after a 12 hour overnight fast (water permitted). Solithromycin is a fluoroketolide antibiotic under investigation for oral and parenteral use and will be administered orally.
16074669|NCT02348411|Device|ExAblate|
16074670|NCT02348398|Drug|Pazopanib|600 mg by mouth daily in a 28 day cycle.
16074671|NCT02348398|Drug|Topotecan|0.25 mg by mouth daily for 21 days of a 28 day cycle.
16074672|NCT02348398|Behavioral|Phone Call|During follow up if disease gets worse, participant called by study staff every 3 months. Each call should last about 5 minutes.
16074673|NCT02348385|Drug|Amphetamine|Subjects will have 2 PET scans on the same day. Up to 3 hours before the second PET Scan, amphetamine (0.4mg/kg, orally) will be administered.
16074674|NCT02348372|Drug|GSK1278863A Placebo|Matching size, shape and color
16074675|NCT02348372|Drug|GSK1278863A|A round, biconvex, white film coated tablet
16074676|NCT02348359|Drug|X-82|
16074677|NCT02348359|Drug|Anti-VEGF|
16074678|NCT02348359|Drug|Placebo|
16074679|NCT02348346|Other|MVX (titanium dioxide)|The investigators have designed a prospective pre-post evaluation time-based pilot study addressing the microbial colonization of surfaces in four rooms of the ICU before and after coating with titanium dioxide (MVX). During a pre-intervention period cultures will be taken every 7 days from 10 prespecified and marked sites per room for a total duration of 4 weeks (sink, wall, floor, bed rail, door handle, ceiling, keyboard patient room, nurse call button, bedside table and monitor arm). After coating of the rooms with MVX another 4 weeks observation period will be used to gather samples in the post-intervention period.
16074680|NCT02348333|Drug|FYU-981, (Oral daily dosing for 7 days)|Subjects randomized to the FYU-981 arm receive active drug, FYU-981.
16074681|NCT02348333|Drug|Placebo, (Oral daily dosing for 7 days)|Subjects randomized to the placebo arm receive placebo.
16074682|NCT02348320|Biological|Personalized polyepitope DNA vaccine|
16074683|NCT02348307|Drug|FYU-981, (Oral single dosing)|Subjects randomized to the FYU-981 arm receive active drug, FYU-981.
16074684|NCT02348307|Drug|Placebo, (Oral single dosing)|Subjects randomized to the placebo arm receive placebo.
16074685|NCT02348294|Other|Shear- force 19 newton and 3,9 kpa pressure for half an hour|
16074686|NCT02348281|Drug|Bicalutamide|150mg, po, qd, d1-28
16074687|NCT02348268|Other|Manual Therapy|The manual therapy techniques included: (i) anterior-posterior and side-shift of the cervical spine; (ii) muscle energy technique involving side-bending of cervical spine; (iii) neuromuscular technique for restricted C1-C2 rotation; (iv) inhibitive occipital distraction; and (v) cervical stretching: post-isometric relaxation for the upper trapezius, scalene and sternocleidomastoid muscles.
16074688|NCT02348268|Other|Myofascial Release Therapy|The myofascial release therapy techniques included: (i) cranial base release, adjusting the relation of the rectus capitis posterior muscles to the dura mater; (ii) gross release of the sternocleidomastoid muscle; (iii) release of the suprahyoid and infrahyoid muscles; and (iv) release of the retrohyoid fascia.
16074689|NCT02348268|Device|Analgesic therapy|Analgesic therapy consisted of superficial thermotherapy by an infrared lamp (Infra 2000, Enraf Nonius) and TENS (TENSMED 911, Enraf Nonius). The 250-watts infrared lamp was focused at a distance of 50 cm on the cervical area for 15 minutes. TENS employed 80 Hz frequency, 150 µs pulse duration, with 50x50 mm electrodes (Gel-Trode, Enraf Nonius) placed on the painful or metamers areas for 20 minutes.
16074690|NCT02348255|Procedure|Electric Field Therapy|Undergo NovoTTF-100A
16074691|NCT02348255|Biological|Bevacizumab|Given IV
16074692|NCT02348255|Drug|Carmustine|Given IV
16074693|NCT02348255|Other|Quality-of-Life Assessment|Ancillary studies
16074694|NCT02348242|Device|Aqueous Gel|1 drop of Dexpanthenol® 0.2% aqueous gel in the eye every 6 hours
16074695|NCT02348242|Device|Eyelid Occlusion Dressing|Eyelid occlusion using pro-ophta® eyelid occlusion dressing, dressing to be verified every 6 hours and replaced daily
16074696|NCT02348242|Device|Artificial Tears|1 drop of Phylarm® artificial tears in the eye every 6 hours
16074697|NCT02348229|Procedure|ERAS protocols|Normal meal allowed until 6 h before surgery and Carbohydrate drink until 2 h before surgery
16074698|NCT02348229|Procedure|ERAS protocols|No bowel preparation
16074699|NCT02348229|Procedure|ERAS protocols|No nasogastric placement; if used, remove on the 1st postoperative day
16074700|NCT02348229|Procedure|ERAS protocols|Vasoactive drugs used if need be
16074701|NCT02348229|Procedure|ERAS protocols|Temperature management
16074702|NCT02348229|Procedure|ERAS protocols|Intra-abdominal drains not to be used
16074703|NCT02348229|Procedure|ERAS protocols|Intraperitoneal Ropivicaine infusion
16074704|NCT02348229|Procedure|ERAS protocols|"On the 1st postoperative day Nasogastric catheter removed /Urinary catheter removed.
~Oral non-opioid analgesia/Drinking 0.5L liquid. Active mobilisation"
16074705|NCT02348229|Procedure|ERAS protocols|On the 2nd postoperative day：Drains removed Oral diet was initiated
16074706|NCT02348229|Procedure|ERAS protocols|3-4th postoperative day： Stop oral non opioid analgesia
16074707|NCT02348229|Procedure|ERAS protocols|On the5-6th postoperative day Check discharge criteria
16074708|NCT02348229|Procedure|conventional pathway group|No solid foods at dinner before surgery and no liquids 12 h before surgery. Routine bowel preparation Nasogastric placement on the morning of surgery
16074709|NCT02348229|Procedure|conventional pathway group|Routine use of anesthesia medicine. Standard 5-trocar laparoscopy-assisted procedure. I.V. fluids not restricted (Ringer's lactate 20 ml/kg in the first hour, then at the rate of 10-12 ml/kg/h) Routine use of abdominal drainage tubes and placement of catheters.
16075918|NCT02339740|Other|Questionnaire Administration|Ancillary studies
16074710|NCT02348229|Procedure|conventional pathway group|1st postoperative day: Keep Nasogastric catheter Removal of urinary catheter Opioid analgesic by intramuscular injection Parenteral nutrition until flatus. I.V. fluids not restricted Mobilization in bed
16074711|NCT02348229|Procedure|conventional pathway group|2nd postoperative day Patient is advised to get out of bed until 24-48h after surgery
16074712|NCT02348229|Procedure|conventional pathway group|3-4th postoperative day： Remove nasogastric tube after flatus Oral liquids started. Encouraged to walk in the ward.
16074713|NCT02348229|Procedure|conventional pathway group|"5-6th postoperative day：Oral diet was changed from liquids to semi-fluids and normal food.
~Drains removed"
16074714|NCT02348216|Biological|Axicabtagene Ciloleucel|A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells administered intravenously at a target dose of 2 x 10^6 anti-CD19 CAR T cells/kg.
16074715|NCT02348216|Drug|Fludarabine|Administered according to package insert
16074716|NCT02348216|Drug|Cyclophosphamide|Administered according to package insert
16074717|NCT02348203|Drug|Aspirin|Given PO
16074718|NCT02348203|Other|Laboratory Biomarker Analysis|Correlative studies
16074719|NCT02348203|Other|Placebo Administration|Given aspirin placebo PO
16074720|NCT02348203|Other|Placebo Administration|Given zileuton placebo PO
16074721|NCT02348203|Drug|Zileuton|Given PO
16074722|NCT02348190|Other|Lipid/heparin|"32 healthy volunteers will undergo euglycemic - hyperinsulinemic clamping without radioactive isotopes and with (n=16) and without (n=16) lipid/heparin co-infusion for 8 hours.
~Serial (at 0, 1, 2 and 4 h) muscle and fat biopsies and serial blood samples (q' 1 h) will be obtained. The following measurements will be obtained in muscle biopsies and T-cell extracts: PKC-βI and II and PKC-δ, IKK, IκB-α, NFκB, IRS-1 tyrosine phosphorylation, IRS-1 associated PI3- kinase, ICAM, VCAM and e-selectin mRNAs."
16074723|NCT02348177|Drug|lopinavir with ritonavir in 1:1 ratio|During co-treatment of rifampicin containing tuberculosis treatment and lopinavir/ritonavir (4:1) based therapy, additional ritonavir is given to make lopinavir/ritonavir 1:1 ratio
16074724|NCT02348177|Drug|Lopinavir/ritonavir 4:1|This is the conventional dosing of LPV/r 4:1 for HIV when TB treatment has not been started or has been stopped
16074725|NCT02348164|Other|Pink grapefruit first followed by tangerines two weeks later|A 504 gram serving of pink grapefruit was fed as a single meal followed by 234 grams tangerines two weeks later
16074726|NCT02348164|Other|Tangerines first followed by pink grapefruit two weeks later|A 234 gram serving of tangerines was fed as a single meal followed by 504 grams pink grapefruit two weeks later
16074727|NCT02348151|Other|Treadmill|The volunteers will perform the shuttle walk test on the treadmill
16074728|NCT02348151|Other|Corridor|The volunteers will perform the shuttle walk test on the corridor
16074729|NCT02348138|Other|Isometric handgrip training|The two experimental groups (HBT and ST) will receive intervention with isometric handgrip exercise for 12 weeks, and the HBT group without daily supervision.
16074730|NCT02348125|Drug|Mitochondrial Cocktail|
16074731|NCT02348112|Device|Altis Sling|Altis is a minimally invasive, adjustable incontinence sling that is placed through a single incision in the vaginal wall and anchored inside the body. The sling has an integrated tensioning system eliminating the need for additional skin exits.
16074732|NCT02348112|Device|Transobturator or Retropubic Sling|Both transobturator and retropubic slings are a hammock-like mesh placed underneath the urethra to provide support. A single incision is made in the vaginal wall and two incisions in the abdomen. Tensioning of the sling is achieved by pulling the sling through the abdominal incisions.
16074733|NCT02348099|Other|Ultrasound|Abdomen scanned with portable ultrasound to determine presence of subclinical lipohypertrophy.
16074734|NCT02348073|Drug|Vayarin®, supplementation of n-3 PUFA|"Two capsules will be swallowed twice daily, 20 to 30 minutes prior to breakfast and dinner, during 12 weeks, between visit 1 and visit 2.
~At the end of this period, active product will be continued, at the same dose, for a 12 week-open label period. All patients will be administered the active product."
16074735|NCT02348073|Drug|PLACEBO|Two capsules will be swallowed twice daily, 20 to 30 minutes prior to breakfast and dinner, during 12 weeks, between visit 1 and visit 2.
16074736|NCT02348047|Device|Hamilton T1|
16074737|NCT02348034|Device|Prevena Dressing|Prevena dressing will be applied to the closed surgical wound after the elective colorectal surgery to evaluate its ability to reduce surgical site infections.
16074738|NCT02348021|Procedure|Percutaneous coronary intervention (PCI)|
16074739|NCT02348021|Drug|Dual Anti Platelet Therapy|All patients will receive Dual Anti Platelet Therapy for one month
16074740|NCT02348008|Drug|MK-3475|Arm A: Phase 1b Cohort 1: 200mg IV; Arm A: Phase 1b Cohort 2: 200mg IV
16074741|NCT02348008|Drug|Bevacizumab|Arm A: Phase 1b Cohort 1: 10mg IV; Arm A: Phase 1b Cohort 2: 15mg IV
16074742|NCT02348008|Drug|MK-3475|Arm B: Phase II Treatment: 200mg IV
16074743|NCT02348008|Drug|Bevacizumab|Arm B: Phase II Treatment: administered at the maximum safe dose of 5mg or 10mg as established in the Phase 1b dose escalation cohort study.
16074744|NCT02347995|Other|Protein|This training is designed to target the major muscle groups of the leg. Resistance training will be completed through a combination of lower extremity machines and complemented by whole body exercises such as squatting. The lower extremity machines include leg press, leg extension, and leg curl. This group will drink a beverage containing protein after each training session.
16074745|NCT02347995|Other|Placebo|This training is designed to target the major muscle groups of the leg. Resistance training will be completed through a combination of lower extremity machines and complemented by whole body exercises such as squatting. The lower extremity machines include leg press, leg extension, and leg curl.This group will drink a placebo beverage after each training session.
16074746|NCT02347969|Dietary Supplement|X34|Dietary supplement named X34
16074747|NCT02347956|Procedure|Reduced port robotic distal gastrectomy|
16074748|NCT02347930|Other|kidney ultrasound|kidney ultrasound
16074749|NCT02347917|Drug|BBI608|480 mg orally twice daily (960 mg total daily dose)
16074750|NCT02347917|Drug|Pemetrexed|500 mg/m2 I.V. infusion on Day 1 of each treatment cycle (except for cycle 1, in which Pemetrexed will be given on Day 3).
16074751|NCT02347917|Drug|Cisplatin|75 mg/m2 I.V. infusion on Day 1 of each treatment cycle (except for Cycle 1, in which Cisplatin will be given on Day 3).
16075919|NCT02339740|Drug|Tretinoin|Given PO
16074752|NCT02347904|Drug|S-1 and Oxaliplatin|Six courses of oxaliplatin (130 mg/m2) intravenously on day 1 and S-1 (25 mg/m2 b.i.d.) orally from day 1 to 14 every 3 weeks, starting within 12 weeks after esophagectomy
16074753|NCT02347891|Drug|Belimumab|Randomized phase: Week 0 - Week 36
16074754|NCT02347891|Drug|Placebo|Randomized phase: Week 0 - Week 36
16074755|NCT02347878|Drug|Aprepitant|use aprepitant 1 hour before lumbar puncture and intrathecal treatment
16074756|NCT02347865|Drug|AMG 162 - Prolia|500 patients
16074757|NCT02347865|Drug|AMG 162 - Prolia|250 patients, one year later
16074758|NCT02347852|Drug|Regorafenib (Stivarga, BAY73-4506)|Stivarga is available as tablets (40 mg). It is taken in four-week treatment cycles at a recommended starting dose of 160 mg once every day for three weeks, followed by a week off.
16074759|NCT02347839|Procedure|Gefitinib-surgery-gefitinib|neoadjuvant gefitinib followed by surgery, followed by adjuvant gefitinib
16074760|NCT02347813|Drug|Pioglitazone|15 mg of pioglitazone orally for 2 weeks, and if well tolerated, 30 mg pioglitazone orally for 5 1/2 months.
16074761|NCT02347787|Behavioral|IMPaCT|"The IMPaCT intervention has three stages:
~Goal-setting: CHWs will help patients to deconstruct the chronic disease management goal they set with their PCP into patient-driven short-term goals and action plans.
~Tailored Support: CHWs will conduct weekly follow-up for 6 months through either telephone or home visit in order to support the achievement of patients' short-term goals.
~Connection with longitudinal support: IMPaCT CHWs will also facilitate a weekly patient support group."
16074762|NCT02347787|Other|Usual care|
16074763|NCT02347774|Drug|SUN-101 50 mcg BID eFlow (CS) nebulizer|SUN-101 50 mcg twice daily (BID) eFlow (R) Closed System (CS) nebulizer
16074764|NCT02347774|Drug|SUN-101 25 mcg BID eFlow (CS) nebulizer|SUN-101 25 mcg BID eFlow (R) Closed System (CS) nebulizer
16074765|NCT02347774|Drug|Placebo eFlow (CS) nebulizer|Placebo BID eFlow (R) Closed System (CS) nebulizer
16074766|NCT02347761|Drug|SUN-101 50 mcg BID eFlow (CS) nebulizer|SUN-101 50 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
16074767|NCT02347761|Drug|SUN-101 25 mcg BID eFlow (CS) nebulizer|SUN-101 25 mcg twice daily (BID) eFlow Closed System (CS) nebulizer
16074768|NCT02347761|Drug|Placebo BID eFlow Closed System (CS) nebulizer|Placebo twice daily (BID) eFlow Closed System (CS) nebulizer
16074769|NCT02347748|Behavioral|Reading pre-procedure script|Patients will be read a pre-procedure comfort talk script in the pre-procedure work-up area
16074770|NCT02347748|Behavioral|Reading pre-extubation script|Patients will be read a comfort talk script before extubation
16074771|NCT02347748|Behavioral|Reading 2 scripts|"Patients will be read a pre-procedure comfort talk script in the pre-procedure work-up area.
~Patients will be read a comfort talk script before extubation"
16074772|NCT02347735|Other|No interventions, only data collection|Only data is collected from the subjects in both groups.
16074773|NCT02347709|Procedure|Diabetic Foot Ulcer Biopsy|Specimens from both the wound edge and a distal area of skin of patients will be obtained via 3 mm punch biopsy in the Winthrop University Hospital Wound Care Center. Biopsies will be collected from the wound edge prior to routine debridement using the following standard procedures, including the use of anesthetic if needed.
16074774|NCT02347709|Other|Survey|Study subjects from all three groups will be asked to complete a one-page Focused Neuropathy Evaluation. Providers will complete a one-page Focused Neuropathy Evaluation and a complete neurological examination and sensation assessment.
16074775|NCT02347709|Other|Comprehensive Neuropathy Assessment|Standard Monofilament Exam, Vibration Assessment, and Temperature Assessment will be performed on all patients in all study groups.
16074776|NCT02347709|Other|Wound Photography|Digital photographs and wound measurements for patients in Study Group 1 will be obtained per standard protocol at baseline and all subsequent visits.
16074777|NCT02347696|Behavioral|Control|Subjects will follow a diet based on INRAN guidelines without doing any physical activity.
16074778|NCT02347696|Behavioral|LGIMD|Subjects will follow a Low Glycemic Index Mediterranean Diet (LGIMD) without doing any physical activity.
16074779|NCT02347696|Behavioral|Endurance Activity (EA)|"Subject will follow a program of endurance activity as follows:
~Frequency: 3 times/week Duration: 60 minutes
~Intensity:
~weeks 1-4: 14.2 kcal*kg-1*week-1;
~weeks 5-8: 18.9 kcal*kg-1*week-1;
~weeks 9-12: 23.6 kcal*kg-1*week-1."
16074780|NCT02347696|Behavioral|EA+Resistance Training (RT)|"Subject will follow a program of endurance activity as follows:
~Frequency: 3 times/week Duration: 60 minutes
~Intensity (for Endurance activity):
~weeks 1-4: 14.2 kcal*kg-1*week-1;
~weeks 5-8: 18.9 kcal*kg-1*week-1;
~weeks 9-12: 23.6 kcal*kg-1*week-1.
~Resistance activity:
~Muscolation: Training of the bigger muscle groups (chest, shoulders, arms, abdomen, back, glutes and legs);
~Progression: increase of 1-2.5 kg*week-1
~Training of all muscle groups in the same session"
16074781|NCT02347696|Behavioral|LGIMD+EA|Subjects will follow a Low Glycemic Index Mediterranean Diet together with a program of endurance activity.
16074782|NCT02347696|Behavioral|LGIMD+EA/RT|Subjects will follow a Low Glycemic Index Mediterranean Diet together with a program of both endurance activity and resistance training.
16074783|NCT02347670|Behavioral|Efficacy-patient navigator to improve follow-up adherence|Over the course of 1 year, a 6-person team comprised of one attending physician ; ophthalmic technicians, project managers/community health educators , and patient navigators will complete a baseline eye examination visit, baseline assessment, and 2-3 follow-up visits. The equipment will occupy a designated location at each site for 1 to 2 days, from 9 a.m. to 3 p.m., with at least 15 eye examinations performed each day. With assistance from the patient navigator, participants will receive assistance with scheduling appointments, arranging transportation, reminder letters, and referral s for ocular care.
16074784|NCT02347670|Behavioral|Office-Based Usual Care|"Over the course of 1 year, a 6-person team comprised of one attending physician ; ophthalmic technicians, project managers/community health educators , and patient navigators will complete a baseline eye examination visit, baseline assessment, and 2-3 follow-up visits. The equipment will occupy a designated location at each site for 1 to 2 days, from 9 a.m. to 3 p.m., with at least 15 eye examinations performed each day.
~This intervention group will receive a phone number to schedule an appointment. Participants in the usual-care group who have scheduled an appointment will receive an automated phone call similar to the standard appointment-reminding procedure used at the Wills Eye Hospital."
16074785|NCT02347657|Drug|VX-661 Plus Ivacaftor Combination|FDC tablet, oral use
16074786|NCT02347657|Drug|Ivacaftor|Tablet, oral use
16074787|NCT02347657|Drug|VX-661 Plus Ivacaftor Combination Placebo|FDC tablet, oral use
16074788|NCT02347657|Drug|Ivacaftor placebo|Tablet, oral use
16074789|NCT02347644|Behavioral|Brief Motivational Interview|"Motivational interviewing is a technique which aims to be both non-judgmental and non-confrontational. Its success depends largely on the presentation of objective feedback based on information provided by an individual. The technique involves acknowledgement that individuals who attend a counselling session, assessment or prevention program may be at different levels of readiness to change their alcohol consumption patterns, including:
~No perception of any alcohol consumption problem
~Realization of alcohol consumption problem with no corresponding action"
16074790|NCT02347631|Device|Soft Contact Lens - Daily Disposable Alcon Dailies Total 1 and ACUVUE TruEye|"Soft contact lens - Daily wear disposable lens to correct myopia in subjects who are nearsighted. Comparison of Alcon Dailies Total 1 versus Acuvue TruEye when worn as daily disposables over a two month period. This is a cross-over study where both brands of lenses will be worn by each participant over the course of the trial. Participants will be randomized for the order in which the two brands of lenses will be worn. There is a washout period of one month in between each 2 month contact lens wearing period.
~In this experimental arm, Alcon Dailies Total 1 lenses will be worn first."
16074791|NCT02347631|Device|Soft Contact Lens - Acuvue TruEye and Alcon DAILIES TOTAL 1.|"Soft contact lens - Daily wear disposable lens to correct myopia in subjects who are nearsighted. Comparison of Alcon Dailies Total 1 versus Acuvue TruEye when worn as daily disposables over a two month period. This is a cross-over study where both brands of lenses will be worn by each participant over the course of the study. Participants will be randomized for the order in which the two brands of lenses will be worn. There is a washout period of one month in between each 2 month contact lens wearing period.
~In this active comparator arm, Acuvue TruEye lenses will be worn first."
16074792|NCT02347618|Radiation|Preoperative SBRT|This will be a Phase 2, single center, prospective, single arm feasibility study of the use of stereotactic body radiotherapy (SBRT) for the preoperative treatment of surgically resectable pancreatic adenocarcinoma.
16074793|NCT02347605|Drug|Nicotine lozenge 4 mg|
16074794|NCT02347605|Drug|Placebo lozenge|
16074795|NCT02347592|Device|Self-locating Catheter|Procedure/Surgery necessary if obstruction occurs
16074796|NCT02347592|Device|straight Tenckhoff|Procedure/Surgery necessary if obstruction occurs
16074797|NCT02347566|Behavioral|Physical activity enhancing programme|COPD patients performing pulmonary rehabilitation will wear the DirectLife activity monitor with set targets and feedback. They will have access to a web coaching programme. Their physical activity targets will be updated on a weekly basis in order to enhance their physical activity.
16074798|NCT02347566|Other|Usual care|COPD patients performing pulmonary rehabilitation will wear the DirectLife activity monitor without set targets and/or feedback. They will not have access to a web coaching programme.
16074799|NCT02347553|Other|This is not an interventional study|Participants will act as their own controls and will undergo the study procedure once in a hypoglycaemic state and once in a euglycaemic state. Therefore there is no intervention being studied as such.
16074800|NCT02347527|Behavioral|Active Implicit Priming|A 10-minute implicit priming intervention, associating food images with images of positive or negative valence.
16074801|NCT02347527|Behavioral|Control Implicit Priming|A 10-minute implicit priming intervention, associating food images with images of neutral valence.
16074802|NCT02347514|Behavioral|Diabetes group visit|
16074803|NCT02347501|Drug|Sitagliptin (Januvia)|Sitagliptin 100mg tablet once daily (or 50mg once daily for participants with moderate kidney disease) for twenty four weeks in patients due to undergo NBUVB light therapy.
16074804|NCT02347488|Device|Haider ETT Tube Holder and Bite Guard|Surgery patients will have endotracheal tubes secured with a novel combined endotracheal tube holder and bite guard change in ETT tip position caused by traction up to 15N was measured prior to surgery.
16074805|NCT02347488|Procedure|Tape|Surgery patients will have endotracheal tubes secured with adhesive tape, as the current clinical procedure; change in ETT tip position caused by traction up to 15N measured prior to re-securing the ETT with the Haider device.
16074806|NCT02347475|Other|Observational Study|Ultrasound and NIRS
16074807|NCT02347462|Device|Bilevel Positive Airway Pressure (BiPAP) (Trilogy BiPAP, Philips Respironics)|Children in the intervention group will receive BiPAP (Trilogy, Philips Respironics; spontaneous trigger mode) via a nasal or full face mask. End expiratory positive airway pressure (EPAP) will be set at 5cm H20. Inspiratory positive airway pressure (IPAP) will be titrated to achieve a tidal volume of 6 - 9 ml/kg. These settings will remain unchanged throughout the study period.
16074808|NCT02347462|Other|Standard care|Standard care according to the hospital severe asthma protocol
16074809|NCT02347449|Other|Questionnaires, Oncotype Dx Assay|"Physician pre-assay questionnaire
~Patient pre-assay questionnaire
~Oncotype DX® Assay
~Physician post- assay questionnaire
~Patient post-assay questionnaire"
16074810|NCT02347436|Procedure|24-hr ambulatory blood pressure measurement|
16074811|NCT02347423|Biological|Primary series of immunisation comprised by 3 vaccinations IPV-Al SSI|
16074812|NCT02347423|Biological|IPV Vaccine SSI|
16074814|NCT02347397|Device|SS Bipolar Head + SL-TWIN Stem|Subject will undergo hemiarthroplasty surgery with SS Bipolar Head & SL-TWIN Stem
16074815|NCT02347397|Device|Bipolar Head + SL-PLUS Stem|Subject will undergo hemiarthroplasty surgery with Bipolar Head & SL-PLUS Stem
16074816|NCT02347384|Device|Delta PLUS Femoral Head + SL-TWIN Stem|Subject will undergo total hip arthroplasty with Delta PLUS Femoral Head & SL-TWIN Stem
16074817|NCT02347384|Device|BIOLOX forte ball head + SL-PLUS Stem|Subject will undergo total hip arthroplasty with BIOLOX forte ball head & SL-PLUS Stem
16074818|NCT02347358|Device|JRecanTM blood FR device|JRecanTM blood flow recanalisation device
16074819|NCT02347358|Drug|IV r-tPA|intravenous recombinant human tissue plasminogen activator
16074820|NCT02347345|Drug|Harvoni (Fixed dose combination ledipasvir/sofosbuvir)|Harvoni (Fixed dose combination ledipasvir/sofosbuvir), one pill daily x 12 weeks
16074821|NCT02347332|Drug|Vinflunine|
16074822|NCT02347332|Drug|Methotrexate|
16074823|NCT02347319|Drug|Pennel|Pennel 2 Tablet, Legalon Placebo 1 tablet, Tid
16074824|NCT02347319|Drug|Legalon|Pennel Placebo 2 Tablet, Legalon 1 tablet, Tid
16074825|NCT02347319|Drug|Placebo|Pennel Placebo 2 Tablet, Legalon Placebo 1 tablet, Tid
16074826|NCT02347306|Other|Telephone interview|
16074827|NCT02347293|Other|High levels of indigestible carbohydrates|
16074828|NCT02347293|Other|Low levels of indigestible carbohydrates|
16074829|NCT02347280|Procedure|Loop Ileostomy with colonic lavage|creation of a loop ileostomy, intraoperative colonic lavage with warmed polyethylene glycol via the ileostomy and postoperative antegrade instillation of vancomycin flushes into the diseased colon via the ileostomy
16074830|NCT02347280|Procedure|Total Abdominal Colectomy with end ileostomy|Removal of entire colon with preservation of rectal stump and construction of end ileostomy
16074831|NCT02347267|Behavioral|Caloric and non-caloric SSBS reduction|Isocaloric individualized diet and sweetened caloric and non-caloric beverages restriction
16074832|NCT02347267|Behavioral|Caloric SSBS reduction|Isocaloric individualized diet and caloric SSBS restriction
16074833|NCT02347254|Device|Transcranial ExAblate|Transcranial ExAblate MRgFUS
16074834|NCT02347241|Other|Educational intervention|Educational Debriefings and High frequency training and team reflection
16074835|NCT02347228|Drug|OB318 capsule|Oral qd, at least 30 minutes before breakfast
16074836|NCT02347215|Other|Quality of Life assessment|Seattle Angina Questionnaire and other questionnaires.
16074837|NCT02347215|Procedure|Stress imaging|Stress imaging
16074838|NCT02347202|Other|Online counseling via Zoom teleconferencing|
16074839|NCT02347202|Other|Telephone support as needed|
16074840|NCT02347189|Device|Melody Transcatheter Pulmonary Valve PB1016|
16074841|NCT02347176|Other|Placebo|Subcutaneous injection with placebo
16074842|NCT02347176|Biological|Tralokinumab Dose 1|Subcutaneous injection with tralokinumab
16074843|NCT02347176|Biological|Tralokinumab Dose 2|Subcutaneous injection with tralokinumab
16074844|NCT02347176|Biological|Tralokinumab Dose 3|Subcutaneous injection with tralokinumab
16074845|NCT02347163|Drug|Zoledronate|Patients fulfilling the eligibility criteria will be registered using a centralized system and will receive a pre-operative, single administration of zol (4mg i.v.), 7 days before definitive breast surgery .
16074846|NCT02347137|Other|step-reduction|reduce daily physical activity to less than 1500 steps per day
16074847|NCT02347137|Other|step-reduction plus resistance exercise|reduce physical activity to less than 1500 steps per day with thrice weekly low-load, high effort resistance exercise
16074848|NCT02347124|Behavioral|Usual Care Control|Standard quitline counseling and other treatment materials provided through each participating state quitline program + a series of text messages with general health promotion tips.
16074849|NCT02347124|Behavioral|Enhanced Intervention|Standard quitline counseling and other materials provided through each participating state quitline program + oral health-focused counseling + oral health focused text messages + access to additional oral health educational content (website and written materials) + oral health tools (toothbrush, dental floss)
16074850|NCT02347111|Drug|Flecainide|flecainide up to 150mg twice daily for the control of atrial fibrillation
16074851|NCT02347111|Drug|Sotalol|sotalol up to 120mg twice daily for the control of atrial fibrillation
16074852|NCT02347098|Device|intensive LDL-lowering therapy|The intensive LDL-lowering therapy uses LDL-apheresis in addition to the standard statin therapy. The device used in this study is the LIPOSORBER LA-15 System, manufactured by Kaneka Pharma America LLC. A filter separates plasma from whole blood, the Liposorber -columns remove LDL from the plasma. The system recombines plasma and blood cells and returns them into the patient's body. This procedure typically takes about 3 hours. The procedure provides an immediate reduction in a patient's lipid levels. A single apheresis treatment can lower LDL by more than 80%, but levels return to baseline within 3 weeks.
16074853|NCT02347098|Drug|standard statin monotherapy|The standard statin therapy of 40-80mg oral daily dose of Atorvastatin or other equivalent types of statin to lower LDL in blood for both randomized groups.
16074854|NCT02347085|Drug|GFF MDI (PT003)|
16074855|NCT02347085|Drug|Placebo MDI|
16074856|NCT02347072|Drug|GFF MDI (PT003)|
16074857|NCT02347072|Drug|Placebo MDI|
16074858|NCT02347072|Drug|Spiriva® Respimat® (Tiotropium Bromide)|Tiotropium Bromide Inhalation Solution; Spiriva® Respimat® (Spiriva)
16074859|NCT02347059|Drug|L-dopa|Antiparkinsonian medication
16074860|NCT02347059|Drug|Dopamine Agonists (pramipexole, ropirinole)|Antiparkinsonian medication
16074861|NCT02347046|Drug|FYU-981, (Oral single dosing)|FYU-981, (Oral single dosing)
16074862|NCT02347033|Drug|Sertraline|"Sertraline will be prescribed by the patients' GP, starting at 25mg daily for 1-2 weeks and increasing to 50mg daily if tolerated. The GP should review the patient within the first 2 weeks, checking for acceptability, concordance and any side-effects, with further reviews at 6 and 12 weeks. We expect the usual treatment dose to be 50 to 100mg daily, although some may require 150mg.
~We will suggest that the GPs use their usual procedures to review the patient's progress, asking about and noting functional change as well as clinical improvement. Minimal improvement after 12 weeks at a maximal tolerated dose should prompt consideration of change of treatment. If there has been an adequate therapeutic benefit there should be further review at 26 and 52 weeks."
16074863|NCT02347033|Behavioral|Cognitive Behavioural Therapy|"CBT will consist of 14 (+ / - 2) weekly 50-minute sessions and will cover 6 treatment modules: psychoeducation and worry awareness training; re-evaluation of the usefulness of worry; uncertainty recognition and behavioural exposure; problem-solving training; written exposure; and relapse prevention.
~Sessions will be digitally recorded and a random 10% assessed for quality (fidelity to the manual and therapist competence) by an independent external assessor according to pre-specified criteria. Patient consent for this will be obtained as part of obtaining informed consent."
16074882|NCT02346864|Behavioral|Three-stair-position|Infants in the TSP group received three-stair-prone position. Implementation steps were as following: 1) produced pad of three-stair-prone position the total height of which should be the same height as the head elevated 15 °. 2) Placed the infants on the pad with head on the highest ladder, chest on the second step and leg on the third step, bending the knees to the chest
16074928|NCT02346526|Procedure|CT scan|Standard CT scans will be carried out prior to treatment, week 9, and week 25.
16074864|NCT02347020|Behavioral|Normal Sleep/ Normal Meal|The subject will be inpatient for 5 days, and sleep between the hours of 0000-0800 h, with meals at 1, 5, 11, and 12.5 (snack) h after awakening every day for 5 days. On night 3, we will insert a catheter in the participant's arm to facilitate multiple blood sampling overnight and the next day. On d 4, a frequently sampled i.v. glucose tolerance test (FSIVGTT) will be performed. A MTT will be performed at the scheduled lunch. At 1 h before dinner, participants will undergo fMRI scanning to assess neuronal responses to food stimuli and to examine functional connectivity with reward circuitry. On d 5, participants will be allowed to determine their own food intake at the scheduled meal and snack times. Participants will be discharged upon awakening on day 6.
16074865|NCT02347020|Behavioral|Normal Sleep/ Late Meal|The subject will be inpatient for 5 days and sleep between the hours of 0000-0800 h,with controlled meals at 4.5, 8.5, 14.5, and 16 (snack) h after awakening. On night 3, we will insert a catheter in the participant's arm to facilitate multiple blood sampling overnight and the next day. On d 4, at the scheduled breakfast time, a frequently sampled i.v. glucose tolerance test (FSIVGTT) will be performed. A MTT will be performed at the scheduled lunch. At 1 h before dinner, participants will undergo fMRI scanning to assess neuronal responses to food stimuli and to examine functional connectivity with reward circuitry. On d 5, participants will be allowed to determine their own food intake at the scheduled meal and snack times. Participants will be discharged upon awakening on day 6.
16074866|NCT02347020|Behavioral|Late Sleep/ Normal Meal|The subject will be inpatient for 5 days, and sleep between the hours of 0330-1130 h, with controlled meals at 1, 5, 11, and 12.5 (snack) h after awakening. On night 3, we will insert a catheter in the participant's arm to facilitate multiple blood sampling overnight and the next day. On d 4, at the scheduled breakfast time, a frequently sampled i.v. glucose tolerance test (FSIVGTT) will be performed. A MTT will be performed at the scheduled lunch. At 1 h before dinner, participants will undergo fMRI scanning to assess neuronal responses to food stimuli and to examine functional connectivity with reward circuitry. On d 5, participants will be allowed to determine their own food intake at the scheduled meal and snack times. Participants will be discharged upon awakening on day 6.
16074867|NCT02347020|Behavioral|Late Sleep/ Late Meal|The subject will be inpatient for 5 days, and sleep between the hours o 0330-1130 h, with controlled meals at 4.5, 8.5, 14.5, and 16 (snack) h after awakening. On night 3, we will insert a catheter in the participant's arm to facilitate multiple blood sampling overnight and the next day. On d 4, at the scheduled breakfast time, a frequently sampled i.v. glucose tolerance test (FSIVGTT) will be performed. A MTT will be performed at the scheduled lunch. At 1 h before dinner, participants will undergo fMRI scanning to assess neuronal responses to food stimuli and to examine functional connectivity with reward circuitry. On d 5, participants will be allowed to determine their own food intake at the scheduled meal and snack times. Participants will be discharged upon awakening on day 6.
16074868|NCT02347007|Dietary Supplement|Almond|Participants will be randomized to consume approximately 17.5% of their estimated energy requirements from almonds daily for 24 weeks. Prescribed energy requirements will be determined for each participant individually using the Mifflin St Jeor Equation equation with an activity factor of 1.3. Participants will be asked to consume half of their daily almond supplement as a mid-afternoon snack and the rest at a meal of their choice.
16074869|NCT02347007|Dietary Supplement|Cereal Bar|Participants will be randomized to consume approximately 17.5% of their estimated energy requirements from cereal bars daily for 24 weeks. Prescribed energy requirements will be determined for each participant individually using the Mifflin St Jeor Equation equation with an activity factor of 1.3. Participants will be asked to consume half of their daily cereal bar supplement as a mid-afternoon snack and the rest at a meal of their choice.
16074870|NCT02346994|Dietary Supplement|Melt Test Blend 3.2|Participant will be given a standard breakfast (containing 20 g of fat from test blend 3.2) to consume over a 10-min period. Test blend 3.2 will be provided in test muffins. The test breakfast will provide 35% of the participant's daily energy requirements, estimated using the Schofield equation. The muffin will provide 450 kcal, and the rest of the energy will be in the form of fat free yogurt, up to 140 kcal, and applesauce.
16074871|NCT02346994|Dietary Supplement|Corn Oil|Participant will be given a standard breakfast (containing 20 g of fat from corn oil) to consume over a 10-min period. Corn oil will be provided in test muffins. The test breakfast will provide 35% of the participant's daily energy requirements, estimated using the Schofield equation. The muffin will provide 450 kcal, and the rest of the energy will be in the form of fat free yogurt, up to 140 kcal, and applesauce.
16074872|NCT02346981|Behavioral|Resistance training|Supervised resistance training program was performed on three nonconsecutive days per week at morning period for 12 weeks. The resistance training program included eight exercises in two consecutive sets of 10-15 repetitions until moderate fatigue, except for crunch exercise which was performed on 20 to 30 repetitions without overload. The participants were instructed to perform repetitions at a ratio of 1:2 (concentric and eccentric phases, respectively). Subjects rested for 60- to 90-s between each set and for 2- to 3-min between each exercise. Each subject was individually supervised. Increases of 2-5 % for the upper limb exercises and 5-10 % for the lower limb exercises every time that subjects were able to complete 15 repetitions in both sets.
16074873|NCT02346968|Other|Blood and urine sampling|Blood and urine sampling (in the context of routine sampling)
16074874|NCT02346955|Biological|CM-24 (MK-6018)|humanized IgG4 (kappa) isotype monoclonal antibody against CEACAM1 by intravenous (IV) infusion
16074875|NCT02346955|Biological|Pembrolizumab (MK-3475)|200 mg of Pembrolizumab by IV infusion
16074876|NCT02346929|Other|ultrasound guide|Patients randomized to this arm will have the hematoma block of the distal radial fracture with the guidance of a bedside ultrasound
16074877|NCT02346916|Drug|Capsaicin|1 inch ribbon of Capzasin-HP 0.1% will be applied to the forearm for 30 minutes
16074878|NCT02346903|Drug|Capsaicin|one inch ribbon of Capzasin -HP applied to forearm for 30 minutes
16074879|NCT02346890|Drug|AZD1722|
16074880|NCT02346890|Drug|Renvela|
16074881|NCT02346877|Behavioral|Personalized Patient Counselling|In the interventional cohort participants enrolled on the study will receive personalized patient counselling using the IMS-model based on the baseline BMQ results through a patient assistance program for patients on Enbrel (Etanercept) therapy.
16074883|NCT02346864|Behavioral|Head elevated tilt position group|Infants in the HETP group were allowed head up 15 ° prone position using a protractor with head to one side, arms against the sides of the body naturally bending, knees bent to the chest.
16074979|NCT02346188|Dietary Supplement|Placebo|
16074884|NCT02346851|Procedure|Functional Electrical Stimulation (FES) treatment|This study is randomized controlled trial performed by Random permuted blocks. This study has 2 experimental groups and 1 control group. Both experimental group receive FES treatment of their posterior deltoid and supraspinatus. Experimental group 1(Acceleration group) uses Novastim CU FS1 once a day for 30 minutes during 3 weeks. During treatment patient give a maximal effort for shoulder abduction. Experimental group 2 (Convention group) receive cyclic FES treatment for reducing shoulder subluxation. All patients have evaluation pre-intervention, post-intervention, 3 weeks after intervention and 9 weeks after intervention including physical examination and x-ray.
16074885|NCT02346838|Dietary Supplement|Inulin|The treatment will be mixed in orange juice or other beverage and will be consumed at breakfast each day in our metabolic kitchen.
16074886|NCT02346838|Dietary Supplement|Placebo|The placebo will be mixed in orange juice or other beverage and will be consumed at breakfast each day in our metabolic kitchen.
16074887|NCT02346825|Behavioral|Neurorehabilitation therapy with cast|Children in this group will have 3 hours of daily therapy each weekday for 4 weeks while wearing a full-arm cast on their stronger arm and hand. Parents will be required to do 45 minutes of daily therapy for which they will be trained.
16074888|NCT02346825|Behavioral|Neurorehabilitation therapy with splint|Children in this group will have 3 hours of daily therapy each weekday for 4 weeks while wearing part-time splint on their stronger arm and hand. Parents will be required to do 45 minutes of daily therapy for which they will be trained.
16074889|NCT02346825|Behavioral|Neurorehabilitation bimanual|Children in this group will have 3 hours of daily therapy each weekday for 4 weeks will not wear a constraint. Parents will be required to do 45 minutes of daily therapy for which they will be trained.
16074890|NCT02346812|Other|Controlled diet without brassica vegetables|Participants will be fed a controlled diet containing foods of a typical American diet.
16074891|NCT02346812|Other|Controlled diet with brassica vegetables|Participants will be fed a controlled diet containing foods of a typical American diet.
16074892|NCT02346799|Behavioral|Workout Window Reminders|Participants will receive emails at prespecified times reminding them to exercise, either during a specific two hour window or at any time during the day.
16074893|NCT02346799|Behavioral|Individual Workout Incentive Payment|Participants will be paid $3 or $7 for each workout completed during the appropriate times.
16074894|NCT02346799|Behavioral|Lump Incentive Payments|Participants will receive $20 payments for completing post treatment survey.
16074895|NCT02346799|Behavioral|Partner Assignment|"Participants will be required to have same workout window as partners."
16074896|NCT02346786|Dietary Supplement|eau minérale d'Aix-Les-Bains|Sodium 0.44 mg Magnésium 2.25 mg Phosphore 0.003 mg Potassium 0.08 mg Calcium 8.23 mg Manganèse 0.0001 mg Fer 0.001 mg Cuivre 0.0005 mg Zinc 0.0005 mg Sélénium 1 µg Iode 0 µg
16074897|NCT02346786|Dietary Supplement|tap water|
16074898|NCT02346773|Dietary Supplement|ω-3 LC-PUFA|The intervention product was a full fat (80%) margarine.Participants were provided with one-month supply of the intervention product (including reserve products) at the onset of the intervention and received a new supply monthly. The intervention products were provided in neutral serving-sized cups, each containing 10 grams of margarine.The child's parents were instructed to have their child consume one complete portion pack (10 g) of margarine per day. The margarine had to be consumed as spread on sandwiches, crackers or bread rolls.The intervention product could be consumed on various periods over the day or all at one occasion. Every day a new portion pack had to be used, even if there was margarine left in the package of the previous day.
16074899|NCT02346773|Other|Placebo|The placebo product was a similar margarine with the same sensory properties, but with monounsaturated fatty acids (MUFA; refined plant oils) replacing EPA and DHA; total saturated fatty acids (SAFA) and ω-6 long chain polyunsaturated fatty acids (LC-PUFA) content were similar between the active and placebo products.
16074900|NCT02346760|Drug|UB-621|100 mg/ml, subcutaneous injection
16074903|NCT02346734|Device|Multiple Sclerosis Home Automated Telemanagement (MS HAT) system|
16074904|NCT02346721|Drug|SOF/VEL|400/100 mg tablet administered orally once daily
16074905|NCT02346708|Device|Real TMS|real treatment
16074906|NCT02346708|Device|Sham TMS|placebo treatment
16074907|NCT02346682|Drug|venlafaxine|Venlafaxine dose was initiated at 75 mg/day and escalated to an optimal dose (150-225 mg/day in most cases) within 2 week, depending upon individual patient response, but the maximum dose could not exceed 300 mg/day during the next 4 weeks. Patients were prescribed a combination of venlafaxine and Benzodiazepines for sleep disturbance.
16074908|NCT02346669|Procedure|gastroscopy|as detailed in arm description
16074909|NCT02346669|Drug|Fecal Microbiota Transplantation|as detailed in arm description
16074910|NCT02346669|Other|high fat low fiber diet|as detailed in arm description
16074911|NCT02346669|Other|sham diet|as detailed in arm description
16074912|NCT02346669|Other|low fat high fiber diet|as detailed in arm description
16074913|NCT02346656|Device|Implantation with the commercially available Axium neurostimulator|
16074914|NCT02346643|Device|Implantation with the commercially available Axium Neurostimulator|
16074915|NCT02346630|Drug|Placebo|Placebo capsules daily for 3 weeks.
16074916|NCT02346630|Drug|Levodopa / Carbidopa|Levodopa / Carbidopa drug 100/25 mg once a day for 3 weeks.
16074917|NCT02346630|Device|Armeo|Armeo Robotic Assisted Intensive Upper Extremity Therapy every weekday for 3 weeks.
16074918|NCT02346617|Biological|IFN-γ positive selected T-cells|No intervention
16074919|NCT02346591|Behavioral|Jauntly|Mobile app designed to encourage positive emotion-enhancing and stress reduction activities.
16074920|NCT02346591|Behavioral|Online stress management information|Online educational information about stress management
16074921|NCT02346578|Drug|Enzalutamide|
16074922|NCT02346578|Drug|Flutamide|
16074923|NCT02346565|Procedure|Exercise ECG|
16074924|NCT02346565|Procedure|Stress Echocardiography|
16074925|NCT02346552|Device|AutoLap|
16074926|NCT02346539|Drug|Nicotine polacrilex|Single Acute dose
16074927|NCT02346526|Procedure|Blood Tests|Blood will be drawn for standard and nonstandard testing on day one, day 4, and weeks 5, 9, 13, 17, 21, 25, 37, and 93.
16074929|NCT02346526|Procedure|FACBC PET/MRI in a subset of participants|Approximately half of the study patients (n=10) will undergo experimental FACBC PET/MRI testing at 2 time points each: (1) prior to therapy, and (2) week 9.
16074930|NCT02346526|Drug|Radium-223 dichloride|Ra-223- Each treatment cycle lasts 4 weeks during which the patient receives Ra-223 at a dose of 50 kBq/kg body weight by intravenous infusion on day 1 only. Treatments are given every 4 weeks for a total of 6 treatments.
16074931|NCT02346526|Procedure|bone scan|Standard bone scans will be carried out prior to treatment, week 9, and week 25.
16074932|NCT02346513|Device|Ceramic on Metal Articulation|Patients have THA with ceramic on metal articulation
16074933|NCT02346513|Device|Non-Ceramic on Metal Articulation|Patients have THA with non-ceramic on metal articulation
16074934|NCT02346500|Device|Transrectal Ultrasound|The TRUS and TRUS-Robot will be used to record ultrasound images during PVP. The PVP procedure will be conducted as usual, without using the ultrasound for guiding the intervention.
16074935|NCT02346487|Drug|LPV/RTV pellets and AZT/3TC or ABC/3TC|"Drug: LPV/r pellets 40/10 mg: orally taken twice a day. Dosage according to patient's weight:
~Between 3 and 5.9kg: 2 capsules twice a day
~Between 6 and 9.9kg: 3 capsules twice a day
~Between 10 and 13.9kg: 4 capsules twice a day
~Between 14 and 19.9kg: 5 capsules twice a day
~Between 20 and 24.9kg: 6 capsules twice a day
~Drug: NRTIs (AZT/3TC 60/30mg tablet or ABC/3TC 60/30mg tablet). Dosage according to patient's weight:
~Between 3 and 5.9kg: 1 tablet twice a day
~Between 6 and 9.9kg: 1.5 tablets twice a day
~Between 10 and 13.9kg: 2 tablets twice a day
~Between 14 and 19.9kg: 2.5 tablets twice a day
~Between 20 and 24.9kg: 3 tablets twice a day"
16074936|NCT02346461|Drug|ManNAc|At doses of 3 g and 6 g twice daily for a total dose of 6 and 12 g per day.
16074937|NCT02346461|Drug|ManNAc|At doses of 6 g twice daily (12 g per day).
16074938|NCT02346448|Procedure|endoscopic sphincterotomy|sphincterotomy during ERCP
16074939|NCT02346448|Procedure|balloon dilatation for 3 minutes|balloon dilatation during ERCP using 10mm balloon
16074940|NCT02346448|Procedure|balloon dilatation for 6 minutes|balloon dilatation during ERCP using 10mm balloon
16074941|NCT02346422|Genetic|MYDICAR Phase 1|Single dose of MYDICAR
16074942|NCT02346422|Genetic|MYDICAR Phase 2|Single dose of MYDICAR
16074943|NCT02346422|Genetic|Placebo Phase 2 only|Single dose of placebo
16074944|NCT02346409|Device|tACS of the cerebellum|tACS of the cerebellum
16074945|NCT02346396|Device|tDCS (use at home)|During 4 weeks (every week : 20 minutes / day during 5 days)
16074946|NCT02346383|Device|preset program|Change to different present program using epidural and peripheral lead to cover pain
16074947|NCT02346370|Drug|PEGylated recombinant human hyaluronidase PH20|
16074948|NCT02346370|Drug|Docetaxel|
16074949|NCT02346357|Procedure|Obturator Nerve Block|Ultrasound-guided obturator nerve block with 20 mL of treatment drug (Ropivacaine 0.5% [local anesthetic]) 30 minutes prior to induction of anesthesia.
16074950|NCT02346357|Drug|Ropivacaine|
16074951|NCT02346357|Drug|Placebo Saline|
16074952|NCT02346331|Other|WHO algorithm of fluid boluses guided by physical examination|
16074953|NCT02346331|Other|Frequent patient monitoring|Vital signs and physical exam every 30-60 minutes
16074954|NCT02346331|Other|Early administration of empiric antibiotics|Clinician will be prompted to administer antibiotics within 60 minutes
16074955|NCT02346331|Other|Oxygen delivery|
16074956|NCT02346331|Other|Correction of hypoglycemia|If blood glucose is less than 3.0 mmol/L, IV dextrose will be administered
16074957|NCT02346331|Other|Correction of severe anemia|If hemoglobin is less than 7 mg/dL, clinician will be prompted to offer blood transfusion
16074958|NCT02346318|Drug|Compound Kushen Injection|Compound Kushen Injection 20ml i.v.drip qd, synchronize with radiotherapy, total dosage is 400ml.
16074959|NCT02346305|Device|Non-invasive ventilation|Home NIV installation
16074960|NCT02346279|Other|Questionnaires, EDSS, physical test|6 Meter timed walking test, Nine Hole Peg Test, Berg balance Scale, MSQPT, HAQUAMS, Transition Questionnaire for Patients, Transition Questionnaire for Therapists, EDSS, 6 Minute Walking Test
16074961|NCT02346266|Other|SMART Education|
16074962|NCT02346253|Radiation|Internal Radiation Therapy|Undergo high-dose-rate brachytherapy
16074963|NCT02346253|Drug|Bicalutamide|Given PO
16074964|NCT02346253|Drug|Leuprolide Acetate|Given IM or SC
16074965|NCT02346253|Drug|Goserelin Acetate|Given SC
16074966|NCT02346253|Drug|Triptorelin Pamoate|Given IM
16074967|NCT02346253|Drug|Degarelix|Given SC
16074968|NCT02346253|Other|Laboratory Biomarker Analysis|Correlative studies
16074969|NCT02346253|Other|Quality-of-Life Assessment|Ancillary studies
16074970|NCT02346240|Biological|Certolizumab Pegol|"Active Substance: Certolizumab Pegol
~Pharmaceutical Form: Solution for injection in pre-filled syringe
~Concentration: 200 mg/ mL
~Route of Administration: Subcutaneous use"
16074971|NCT02346240|Biological|Etanercept|"Active Substance: Etanercept
~Pharmaceutical Form: Solution for injection in pre-filled syringe
~Concentration: 50 mg / mL
~Route of Administration: Subcutaneous use"
16074972|NCT02346240|Other|Placebo|"Active Substance: Placebo
~Pharmaceutical Form: Solution for injection in pre-filled syringe
~Concentration: 0.9 % saline
~Route of Administration: Subcutaneous use"
16074973|NCT02346227|Drug|AV2|"The virucide AV2 consists of a spray. It is a mixture of natural essential oil components (Carvone, Eugenol, Geraniol, Nerolidol) in equal volumes diluted 50% in olive oil (Olea europaea).
~It is administered as a topical spray to the cervix while the subject is in the lithotomic position and fitted with a speculum. The manual spray applicator is positioned inside the anterior of the vagina and two pumps are applied. Each pump delivers 100 microliters of the solution."
16074974|NCT02346227|Drug|Placebo|"The placebo consists of 10% lemon (citrus limon) and 10% lime (citrus aurantifolia) in 80% olive oil.
~It is administered as a one time (2 puffs) topical spray of 100 microliters on the cervix."
16074975|NCT02346201|Drug|Methylphenidate|Two 5mg methylphenidate over-encapsulated drug taken twice a day for 6 months (total of 20 mg methylphenidate per day), and psychosocial intervention
16074976|NCT02346201|Drug|Placebo|Two over-encapsulated placebo taken twice a day for 6 months and psychosocial intervention
16074977|NCT02346188|Dietary Supplement|Ferrous fumarate|Tablet formulated from 30 mg ferrous fumarate.
16074978|NCT02346188|Dietary Supplement|Zinc oxide|Tablet formulated from 30 mg zinc oxide
16074982|NCT02346162|Behavioral|Weight management|Phone counseling for pre-pregnancy weight loss and weight maintenance when BMI </=25, and when pregnant, weight gain within IOM guidelines.
16074983|NCT02346162|Other|Usual Care Control|Usual care control participants receive general dietary advice as it relates to planning for a healthy pregnancy (e.g. folate requirements, prenatal vitamins, smoking cessation, alcohol cessation, and prenatal food safety).
16074984|NCT02346149|Other|glucose 20%|Intravenous infusion (0.75 ml / kg) over 1 min
16074985|NCT02346136|Behavioral|Tai Chi training|
16074986|NCT02346136|Behavioral|Educational Control|
16074987|NCT02346123|Genetic|Gathering of samples of genetic material|The samples will be obtained from peripheral blood mononuclear cells and the genotyping of the polymorphisms will be done by real time PCR.
16074988|NCT02346110|Drug|Bupivacaine-adrenaline|50 mg bupivacaine and 50 μg adrenalin
16074989|NCT02346110|Drug|Dexamethasone|4 mg
16074990|NCT02346110|Other|Sodium chloride|1 mL of sodium chloride solution as placebo
16074991|NCT02346097|Device|Cardiac Resynchronization Therapy (St. Jude Qaudripolar LV lead)|"Optimal electrical resynchronization vs. routine CRT strategy, imaging guided. For more details refer to Arm descriptions"
16074992|NCT02346084|Drug|Maraviroc 300 mg tablet (PO) and Maraviroc 1% gel (PR and PV)|"Tablets: daily 300 mg oral maraviroc, Selzentry®,(MVC) for 8 consecutive days Gel: daily rectally administered 1% MVC gel for 8 daily consecutive days Female Participants - will receive an additional third regimen of daily vaginally administered MVC 1% gel for 8 consecutive days.
~Each treatment regimen will be followed by a washout period of 14 to 21 days.
~Participants will also be randomized to a biopsy sampling schedule (i.e., D8, D9, or D10 sampling)."
16074993|NCT02346071|Behavioral|Acceptance and Commitment Therapy|"All patients will have a thorough clinical psychiatric and somatic assessment in order to determine eligibility and a psychiatric consultation (SPC) of 1-1½ hrs. duration approx. 2 weeks after randomization.
~The ACT treatment is manualized and given in groups of 7-8 patients with 9 3-hour sessions (i.e. 27 hours in total) over a period of 3 months and one follow up meeting (3 hours) three months after end of treatment. The parents and other relevant close relatives (e.g. siblings, boy/girlfriends) to the patient participate in a workshop where ACT principles are applied. One individual consultation with the adolescent and parents will be offered at the end of 8 sessions of group therapy."
16074994|NCT02346071|Other|Enhanced Usual Care (EUC)|"All patients will have a thorough clinical psychiatric and somatic assessment in order to determine eligibility and a psychiatric consultation (SPC) of 1-1½ hrs. duration approx. 2 weeks after randomization.
~The consultation is according to a manual and includes psycho-education related to the diagnosis of multiorgan BDS, health promoting recommendations and counselling regarding existing medicine or other treatment. An individualized treatment plan will be sent to the patient's general practitioner, to optimize management in primary care and support by social services."
16074995|NCT02346058|Drug|Esarin Gel|
16074996|NCT02346045|Procedure|Renal sympathetic denervation|"In the experimental arm, Intervention is renal sympathetic denervation using Symplicity® system (Medtronic Ardian Inc, Mountain View, CA, USA) and antihypertensive medications previously prescribed
~After femoral puncture guiding catheter is engaged in renal artery
~Symplicity radiofrequency ablation catheter is inserted into renal artery and by circular sequence, from distal to proximal portion, ablation energy is applied to the wall of renal artery
~4-5 ablations are applied in each renal artery.
~In the sham comparator, intervention is renal angiogram and continue antihypertensive medications previuosly decribed"
16074997|NCT02346032|Drug|refametinib|Refametinib will be administered orally at the starting dose of 50 mg twice daily on a continuous daily dosing schedule.
16074998|NCT02346019|Procedure|Medial thighplasty with or without thigh liposuction|Perform a standard medial thighplasty with or without additional thigh liposuction on up to three obese transfemoral amputee subjects. The subjects will be transfemoral amputees who are successful ambulators and have a body mass index (BMI) of 30 or greater with excessive adipose tissue in their residual limb. The surgery will consist of medial excision of excess adipose and cutaneous tissue with circumferential liposuction.
16074999|NCT02346006|Behavioral|More physical activity.|Subjects receiving more physical activity in school.
16075000|NCT02345993|Drug|Extra fine Formoterol/Beclomethasone|"standard treatment consisting in: Albuterol 2.5 mg via nebulizer at baseline (0), 20, 40 minutes + Systemic steroid (methylprednisolone 60 mg) at the moment of evaluation
~+ formoterol/beclomethasone, 3 puffs administered via aerochamber at baseline (0), 20, 40, 60 minutes"
16075001|NCT02345980|Drug|Sildenafil|
16075002|NCT02345980|Drug|Placebo|
16075003|NCT02345967|Device|Model 100 Sensor|One Model 100 Sensor to be implanted per subject.
16075004|NCT02345954|Procedure|Laparoscopic Supracervical Hysterectomy and Sacropexy|Laparoscopic supracervical hysterectomy and laparoscopic sacrocolpopexy
16075005|NCT02345954|Procedure|Laparoscopic Hysteropexy|Laparoscopic hysteropexy
16075006|NCT02345941|Other|Parent Action Report|Parent Action Report will be displayed after the baseline assessment and contain educational safety messages.
16075007|NCT02345941|Other|Parent Portal|Parents will have access to the Parent Portal, and they will be encouraged to visit it at any time.
16075008|NCT02345928|Drug|Part 1: CNTO 7160|Participants will receive Drug CNTO7160 administered IV infusion at escalating doses (with a starting dose of 0.001 mg/kg).
16075009|NCT02345928|Drug|Part 2 (Asthma): CNTO 7160|Participants will receive Drug CNTO 7160 administered IV infusions (3 dose administrations over 4 weeks).
16075010|NCT02345928|Drug|Part 2 (Atopic Dermatitis): CNTO 7160|Participants will receive Drug CNTO 7160 administered IV infusions (3 dose administrations over 4 weeks).
16075011|NCT02345928|Drug|Part 1 and Part 2: Placebo|Participants will receive single IV infusion of placebo matched to CNTO 7160.
16075012|NCT02345915|Other|Blood sample|
16075013|NCT02345915|Other|Electrocardiogram|
16075014|NCT02345902|Drug|Haloperidol|haloperidol 1.25 mg P.O q.d
16075015|NCT02345902|Other|Placebo|placebo 1.25 mg P.O q.d
16075048|NCT02345746|Drug|5-Fluorouracil|Following Folinic Acid as a continuous infusion over 48 hours on days 2, 3
16075049|NCT02345733|Other|Ulcerative Colitis Diet|we have postulated that a diet that we developed that reduces exposure to dietary ingredients that allow sulfide reducing bacteria to thrive, or that impair the mucous layer, coupled with dietary products that enhance butyrate production, could induce remission in UC without involving additional immune suppression.
16075016|NCT02345902|Other|non-pharmacologic measures|A. Reorientation (i.e., calendar, clocks, familiar objects) B. Glasses and hearing devices for the particular patients needing such aids C. Avoidance of physical restraints D. Limitation of excessive personnel shifts or hospital room E. A tranquil and comfortable environment, especially at night, to avoid interruptions (i.e., dim light, low levels of noise) F. Adequate schedules for medication administration and to take vital signs or medical procedures G. Sleep hygiene (light in the room and movement during the day) H. Avoidance of dehydration I. Avoidance of medications use which are associated with delirium (e.g., psychoactive medications)
16075017|NCT02345889|Device|Colonoscopy with EndoCuff™|colonoscopy performed with an EndoCuff™ device at the tip of a standard colonoscope
16075018|NCT02345889|Device|FUSE® Colonoscopy|colonoscopy performed with the FUSE® (full spectrum endoscopy) system
16075019|NCT02345889|Device|Colonoscopy with EndoRings™|colonoscopy performed with an EndoRings™ device at the tip of a standard colonoscope
16075020|NCT02345889|Device|Standard Colonoscopy|Current standard of care colonoscopy
16075021|NCT02345876|Other|no intervention|
16075022|NCT02345863|Drug|Bendamustine|"Debulking:
~2 cycles of Bendamustine (70 mg/m² iv) will be administered before induction unless a contraindication is existing or it is not clinically indicated."
16075023|NCT02345863|Drug|GA101|"Induction
~GA101 iv infusion:
~Cycle 1: Day 1 100 mg Day 1 (or 2) 900 mg Day 8 1000 mg Day 15 1000 mg Cycle 2-6: Day 1 1000 mg
~Maintenance After the induction ibrutinib po 420 mg daily and GA101 iv 1000 mg every three months will be continued.
~GA101: Cycle 1-8 Day 1 1000 mg"
16075024|NCT02345863|Drug|Ibrutinib|"Ibrutinib will be administered as a daily oral dosage of 420 mg starting on cycle 2 day 1.
~Cycle 2-6: Day 1 420 mg daily
~Maintenance After the induction ibrutinib po 420 mg daily and GA101 iv 1000 mg every three months will be continued.
~Ibrutinib: Cycle 1-8 420 mg daily"
16075025|NCT02345850|Procedure|Unmanipulated Bone Marrow Graft with Tacrolimus/Methotrexate|Unmanipulated BM grafts will be administered on Day 0 to all patients according to individual institutional guidelines after appropriate processing and quantification has been performed by the local laboratory. Stem cells are administered through an indwelling central venous catheter. If infusion occurs over two days, Day 0 is the first day the infusion is initiated.
16075026|NCT02345850|Procedure|Mobilized CD34-selected Peripheral Blood Stem Cell graft|Mobilized CD34-selected PBSC grafts will be administered on Day 0 to all patients according to individual institutional guidelines after appropriate processing and quantification has been performed by the local laboratory. Stem cells are administered through an indwelling central venous catheter. If infusion occurs over two days, Day 0 is the first day the infusion is initiated.
16075027|NCT02345850|Procedure|Unmanipulated Bone Marrow Graft with Cyclophosphamide|Unmanipulated BM grafts will be administered on Day 0 to all patients according to individual institutional guidelines after appropriate processing and quantification has been performed by the local laboratory. Stem cells are administered through an indwelling central venous catheter. If infusion occurs over two days, Day 0 is the first day the infusion is initiated.
16075028|NCT02345850|Drug|Cyclophosphamide|"Mesna will be given in divided doses IV 30 min pre- and at 3, 6, and 8 hours post-cyclophosphamide or administered per institutional standards. Mesna dose will be based on the cyclophosphamide dose being given. The total daily dose of Mesna is equal to 80% of the total daily dose of cyclophosphamide.
~Cyclophosphamide 50 mg/kg will be given on Day 3 post-transplant (between 60 and 72 hours after marrow infusion) and on Day 4 post-transplant (approximately 24 hours after Day 3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours (depending on volume)."
16075029|NCT02345850|Drug|Tacrolimus|Tacrolimus will be given orally or intravenously per institutional standards starting Day -3. The dose of tacrolimus may be rounded to the nearest 0.5 mg for oral formulations. Subsequent dosing will be based on blood levels, with a target of 5-15 ng/ml. If patients are on medications which alter the metabolism of tacrolimus (e.g. azoles), the initial starting dose and subsequent doses should be altered as per institutional practices. Tacrolimus taper can be initiated at a minimum of 90 days post HSCT if there is no evidence of active GVHD. The rate of tapering will be done according institutional practices but patients should be off tacrolimus by Day 180 post HSCT if there is no evidence of active GVHD.
16075030|NCT02345850|Drug|Methotrexate|Methotrexate will be administered at the doses of 15 mg/m^2 IV bolus on Day +1, and 10 mg/m^2 IV bolus on Days +3, +6 and +11 after hematopoietic stem cell infusion. The Day +1 dose of methotrexate should be given at least 24 hours after the hematopoietic stem cell infusion. Dose reduction of MTX due to worsening creatinine clearance after initiation of conditioning regimen, high serum levels or development of oral mucositis is allowed according to institutional practices. Leucovorin rescue is allowed according to institutional practices.
16075031|NCT02345837|Device|endometrial sampling|injury to the endometrium
16075032|NCT02345837|Drug|clomiphene citrate|ovulation induction by 100mg clomiphene citrate
16075033|NCT02345824|Drug|Ribociclib|CDK4/6 INHIBITOR
16075034|NCT02345811|Device|Sapphire|silicone-hydrogel contact lens
16075035|NCT02345811|Device|senofilcon A|contact lens
16075036|NCT02345798|Procedure|Standard Follow-Up Care|Undergo usual care
16075037|NCT02345798|Other|Caregiver-Related Intervention or Procedure|Undergo video-assisted intervention
16075038|NCT02345798|Other|Educational Intervention|Undergo video-assisted intervention
16075039|NCT02345798|Other|Quality-of-Life Assessment|Undergo quality of life assessment
16075040|NCT02345798|Other|Questionnaire Administration|Undergo questionnaire administration
16075041|NCT02345785|Other|urologic surgery and caudal block|
16075042|NCT02345772|Drug|fulvestrant 500 mg|Hormonal therapy with fulvestrant 500 mg will be administered intramuscularly on days 1, 15 of the first cycle, and thereafter on day 1 of every 28-day cycle for up to 5 cycles before surgery.
16075043|NCT02345772|Drug|Docetaxel|Docetaxel (T) 75 mg/m2 every 3 weeks will be given for four cycles.
16075044|NCT02345772|Drug|Trastuzumab (H, 8mg/kg|Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent cycles before and after surgery), pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery.
16075045|NCT02345772|Drug|Pertuzumab (P, 840 mg|Trastuzumab (H, 8mg/kg for 1st cycle, then 6 mg/kg in subsequent cycles before and after surgery), pertuzumab (P, 840 mg for 1st cycle, then 420 mg in subsequent 3 cycles) will be given concurrently with docetaxel for a total of 4 cycles before surgery.
16075046|NCT02345746|Drug|Oxaliplatin|infusion over 12 hours via HAI
16075050|NCT02345733|Drug|Antibiotic cocktail|We have postulating that antibiotic therapy can alter the microbiota clinically. Controlling the microbiota by antibiotics may allow for control of the disease without immune suppression
16075051|NCT02345720|Device|etafilcon - PVP (multi-focal)|The investigational contact lens must be worn at least six hours daily.
16075052|NCT02345707|Drug|Cabotegravir 30 mg current formulation|Cabotegravir 30 mg current formulation (Treatment A) is a film coated tablet with a weight of 824 mg
16075053|NCT02345707|Drug|Cabotegravir 30 mg micronized new formulation 500 M|Cabotegravir 30 mg micronized new formulation 500 M (Treatment B) is a film coated tablet with a weight of 515 mg
16075054|NCT02345707|Drug|Cabotegravir 30 mg unmicronized new formulation 500 U|Cabotegravir 30 mg unmicronized new formulation 500 U (Treatment C) is a film coated tablet with a weight of 515 mg
16075055|NCT02345707|Drug|Cabotegravir 30 mg micronized new formulation 650 M|Cabotegravir 30 mg micronized new formulation 650 M (Treatment D) is a film coated tablet with a weight of 670 mg
16075056|NCT02345707|Drug|Cabotegravir 30 mg unmicronized new formulation 650 U|Cabotegravir 30 mg unmicronized new formulation 650 U (Treatment E) is a film coated tablet with a weight of 670 mg
16075057|NCT02345694|Device|Effective CPAP|Effective Continuous Positive Airway Pressure auto-regulated, worn all night long during 8 weeks
16075058|NCT02345694|Device|Sub-therapeutic CPAP|Sub-therapeutic Continuous Positive Airway Pressure (Sham-CPAP) worn all night long during 8 weeks
16075059|NCT02345681|Drug|Furosemide|
16075060|NCT02345668|Behavioral|Emotion Regulation Protocol|Emotion Regulation Protocol is an Internet-based Self-administered Protocol for emotional disorders, which will allow the individual to learn and practice adaptive ways to regulate their emotions from a transdiagnostic perspective. The protocol contains the following components: present-focused emotional awareness, cognitive flexibility, emotional avoidance and emotion-driven behaviors, interoceptive and situation-based emotion exposure, psychoeducation about emotions, motivational enhancement and relapse prevention, which are organized in twelve modules: Emotional disorders and emotion regulation; Motivation for change; Understanding the role of emotions; The acceptance of emotional experiences; Practicing the acceptance; Learning to be flexible; Practicing the cognitive flexibility; The emotional avoidance; Emotion driven behaviors; Accepting and facing physical sensations; Facing emotions in the contexts in which they occur; and Relapse Prevention.
16075061|NCT02345668|Drug|Treatment as Usual (Pharmacological Treatment)|The Pharmacological Treatment provided by a psychiatrist in the mental health unit.
16075062|NCT02345668|Behavioral|Treatment as Usual (Psychological Treatment)|The Psychological Treatment provided by a clinical psychologist in the mental health unit.
16075063|NCT02345655|Procedure|urine drug testing|Performed a OS-UDT test in general practice on patients starting buprenorphine
16075064|NCT02345655|Other|no test|normal procedure decided by the general practitioner
16075065|NCT02345642|Device|ActiveCare+SFT Supine|
16075066|NCT02345642|Device|VenaFlow Elite Supine|
16075067|NCT02345642|Device|ActiveCare+SFT Standing|
16075068|NCT02345642|Device|VenaFlow Elite Standing|
16075069|NCT02345629|Procedure|Cordotomy|Radiologist performs a spinal tap to inject a contrast drug into the spinal fluid. A 20G spinal needle guided by real-time CT scan to the C1-C2 level opposite to participant's pain. A radiofrequency electrode inserted through the spinal needle into the spinal cord, to the anatomic location of the spinothalamic tract. Once ideal position of the electrode is confirmed, 1 or 2 radiofrequency ablations performed at 70C-80C for 60 seconds. The procedure will take 1-2 hours.
16075070|NCT02345629|Behavioral|Pain/Symptom Questionnaire|Pain and symptom questionnaire completed at baseline, by phone during first week of study, and once each month by phone during 6 month follow up.
16075071|NCT02345629|Procedure|Sharpness Sensory Testing|Sharpness detection determined using 8, 10, 16, 20, 32, 64, and 128g weighted needle devices. Each stimulus applied for about 1 second in ascending order. Participants asked to rate each stimulus as producing the sensation of touch, pressure, sharp, or pain. The sharpness detection threshold defined as the mean force of the stimuli deemed ''sharp'' or ''painful'' from 3 trials separated by an average interval of 30 to 90 seconds.
16075072|NCT02345629|Procedure|Heat Pain Sensory Testing|Thermal ramps will applied using a 3.6 x 3.6 cm Peltier thermode (Medoc Inc.) from a baseline temperature set at 32C. Skin heated at a rate of 0.30C/s, and participants asked to signal when the stimulus is perceived as first becoming warmer and then painfully hot.
16075073|NCT02345616|Drug|Nitric oxide|
16075074|NCT02345603|Procedure|Cryo-therapy|Cryo-therapy for about 60 seconds applied circumpherentially to each renal artery
16075075|NCT02345590|Drug|Eplerenone|25mg of eplerenone
16075076|NCT02345577|Other|Stochastic whole body vibration (WBV) therapy - Physiotherapeutical intervention|Physiotherapeutical intervention
16075077|NCT02345577|Other|Stochastic whole body vibration (WBV) therapy - Sham physiotherapeutical intervention|Sham physiotherapeutical intervention
16075078|NCT02345564|Device|implantation of MaioRegen fleece into osteochondral lesion|arthroscopic localization of lesion, arthroscopic guided mini-arthrotomy and implantation of defect sized MaioRegen fleece
16075079|NCT02345551|Behavioral|Exercise|Moderate-vigorous aerobic activity in line with published guidelines for cancer prevention
16075080|NCT02345525|Behavioral|mCIMT|"This intervention is based on 3 main aspects:
~intensive training of functional tasks with the affected arm (massed practice)
~constraint of the un-affected hand through a mitt
~shaping techniques designed to transfer gains to the real world activities
~The 2 hours massed practice will be performed in a outpatient clinic with a supervision of PT."
16075081|NCT02345525|Behavioral|hCIMT|"This intervention is based on 3 main aspects:
~intensive training of functional tasks with the affected arm (massed practice)
~constraint of the un-affected hand through a mitt
~shaping techniques designed to transfer gains to the real world activities
~In this group, a comprehensive set of the material necessary to perform the training at home and a booklet containing an explanation of the exercises that can be done will be provided to subjects.
~In addition, 2 hospital visits will be scheduled to instruct subjects and caregivers on the training and to update activities (1 visit at the beginning + 1 visit after 1 week)."
16075082|NCT02345512|Device|Lycra Splinting Garment|Wearing of lycra splinting garment for 6 weeks
16075083|NCT02345499|Procedure|Laparoscopic radical cystectomy with open urinary diversion|Laparoscopic surgical procedure in which the bladder is removed because of bladder cancer and a urinary diversion is performed
16075084|NCT02345499|Procedure|Open radical cystectomy with open urinary diversion|Open surgical procedure in which the bladder is removed because of bladder cancer and a urinary diversion is performed
16075085|NCT02345486|Other|0.9% sodium chloride|
16075086|NCT02345486|Other|Physiologically balanced fluid|
16075087|NCT02345473|Genetic|Detection of circulating tumor cells in blood samples|Ficoll based isolation of mononuclear cells from the peripheral blood of patients undergoing radical cystectomy, nucleic acids extraction and, finally, PCR based detection of sequences specific to cytokeratins.
16075088|NCT02345460|Drug|Irinotecan Hydrochloride|Given IV
16075089|NCT02345460|Drug|Oxaliplatin|Given IV
16075090|NCT02345460|Drug|Leucovorin Calcium|Given IV
16075091|NCT02345460|Drug|Fluorouracil|Given IV
16075092|NCT02345460|Other|Laboratory Biomarker Analysis|Correlative studies
16075093|NCT02345447|Drug|Herbal-based medication|Aconitum napellus, Capsicum annuum; Chamomilla recutita; Echinacea purpurea; Hydrargyrum bicyanatum; Hydrastis canadensis; Iodum; Natrium tetraboracicum; Sambucus nigra; Sanguinaria canadensis
16075094|NCT02345447|Drug|Placebo|Aqueous ethanol solution non-distinguishable from verum
16075095|NCT02345434|Other|Informative letter|The intervention is a letter that describes the Schedule II prescribing activity of the individual in comparison to a peer group of similar prescribers. It highlights the fact that the prescriber's activity is highly unlike her peers.
16075096|NCT02345408|Drug|CCX872-B|Tablets (oral administration)
16075097|NCT02345395|Procedure|Aneurysm Clipping|All Patients will be submitted to a surgical intervention in order to clip their unruptured brain aneurysm
16075098|NCT02345382|Drug|Atuveciclib, BAY1143572|The starting dose was 20 mg BAY 1143572 once daily from Cycle 1 Day 1. Each cycle was defined as a period of 28 days. Dosing cycles continued until evidence of progression, unacceptable toxicity, consent withdrawal, or withdrawal from the study at the discretion of the investigator.
16075099|NCT02345369|Device|Locked Set Screw|Fixation of hip fracture with intramedullary hip screw with locking of the set screw
16075100|NCT02345369|Device|Unlocked Set Screw|Fixation of hip fracture with intramedullary hip screw without locking of the set screw
16075101|NCT02345356|Genetic|Genotype-guided|Individual warfarin dose adjustments by using a pharmacogenetically driven algorithm
16075102|NCT02345356|Other|Standard-of-Care|Individual warfarin dose adjustments by using a clinically driven algorithm (standard care)
16075103|NCT02345343|Drug|Apixaban|
16075104|NCT02345330|Biological|Tavokinogene Telseplasmid (tavo)|Patients received intratumoral injection(s) of tavo.
16075105|NCT02345330|Device|OncoSec Medical System (OMS)|Electroporation via OMS was performed immediately following intratumoral injection of tavo. A sterile applicator containing 6 stainless steel electrodes arranged in a circle were placed around the tumor. The applicator was connected to the OMS power supply and six pulses were administered to each tumor lesion at the approximate point of tavo injection.
16075106|NCT02345304|Drug|Omeprazole|
16075107|NCT02345304|Drug|Warfarin|
16075108|NCT02345304|Drug|BI 1181181|
16075109|NCT02345304|Drug|Midazolam|
16075110|NCT02345304|Drug|Omeprazole|
16075111|NCT02345304|Drug|BI 1181181|
16075112|NCT02345304|Drug|Midazolam|
16075113|NCT02345304|Drug|Midazolam|
16075114|NCT02345304|Drug|Warfarin|
16075115|NCT02345304|Drug|BI 1181181|
16075116|NCT02345304|Drug|Digoxin|
16075117|NCT02345304|Drug|Digoxin|
16075118|NCT02345291|Drug|NRD135S.E1|A small chemical entity for treatment of neuropathic pain NRD135S.E1
16075119|NCT02345291|Drug|Placebo to match NRD135S.E1|Placebo capsule to match NRD135S.E1 capsules
16075120|NCT02345278|Drug|SUBLIVAC FIX Mite mixture|Study medication will be taken sublingually once a day. Patients will start with one drop and increase the dose by one drop each consecutive day until the maintenance dose (5 drops/day) is reached. Drops should be kept under the tongue for 2-3 minutes before swallowing. After reaching the maintenance dose patients will be treated up to 1 month.
16075121|NCT02345278|Other|Placebo|Study medication will be taken sublingually once a day. Patients will start with one drop and increase the dose by one drop each consecutive day until the maintenance dose (5 drops/day) is reached. Drops should be kept under the tongue for 2-3 minutes before swallowing. After reaching the maintenance dose patients will be treated up to 1 month.
16075122|NCT02345265|Drug|Cediranib Maleate|Given PO
16075123|NCT02345265|Drug|Olaparib|Given PO
16075124|NCT02345265|Other|Questionnaire Administration|Ancillary studies
16075125|NCT02345252|Drug|FTC/RPV/TAF|200/25/25 mg FDC tablets administered orally once daily
16075126|NCT02345252|Drug|FTC/RPV/TDF Placebo|Tablets administered orally once daily
16075127|NCT02345252|Drug|FTC/RPV/TDF|200/25/300 mg FDC tablets administered orally once daily
16075128|NCT02345252|Drug|FTC/RPV/TAF Placebo|Tablets administered orally once daily
16075129|NCT02345239|Drug|Pantoprazole|proton pump inhibitor
16075130|NCT02345226|Drug|FTC/RPV/TAF|200/25/25 mg FDC tablets administered orally once daily
16075131|NCT02345226|Drug|EFV/FTC/TDF Placebo|Tablets administered orally once daily
16075132|NCT02345226|Drug|EFV/FTC/TDF|600/200/300 mg FDC tablets administered orally once daily
16075133|NCT02345226|Drug|FTC/RPV/TAF Placebo|Tablets administered orally once daily
16075134|NCT02345213|Drug|E2020|E2020 tablets will be orally administered once daily after breakfast
16075135|NCT02345213|Drug|Placebo|Matching placebo tablets will be orally administered once daily after breakfast
16075136|NCT02345200|Procedure|bioelectrical impedance analysis|electrophysical measurement that allows to determine the exact composition of single body compartments by producing a magnetic field and detecting the potential difference through the body
16075137|NCT02345200|Procedure|blood draw|blood samples are taken at 8 am in order to pay attention to the circadian rhythmicity to get a detailed hormonal status
16075138|NCT02345187|Dietary Supplement|Beverage powder fortified with Bacopa Monnieri Extract and Multiple Micronutrient supplementation|The study product (fortified beverage powder reconstituted with 180 mL lukewarm water) will be administered twice daily for 17 weeks
16075139|NCT02345187|Dietary Supplement|Non-fortified isocaloric beverage powder|The study product (non-fortified isocaloric beverage powder reconstituted with 180 mL lukewarm water) will be administered twice daily for 17 weeks
16075140|NCT02345174|Drug|GSK2849330|GSK2849330 solution (100 mg/mL) for infusion diluted in 0.9% sodium chloride to the appropriate concentration for the dose.
16075141|NCT02345174|Drug|89Zr-GSK2849330|89Zr-GSK2849330 solution for intravenous administration diluted with GSK2849330 Solution for Infusion (unlabelled GSK2849330) with a target radioactivity of 37MBq and a total antibody concentration of 0.4 mg/mL or 1.2 mg/mL.
16075142|NCT02345161|Drug|Triple FF/UMEC/VI|The combination will be provided as inhalation via an ELLIPTA DPI having 30 doses (2 strips with 30 blisters per strip). It will have 100 mcg of FF (blended with lactose) per blister, 62.5 mcg of UMEC (blended with lactose and magnesium stearate) per blister and 25 mcg of VI (blended with lactose) per blister.
16075143|NCT02345161|Drug|Placebo to match FF/UMEC/VI|The placebo (Lactose) will be provided as inhalation via an ELLIPTA DPI having 30 doses (2 strips with 30 blisters per strip).
16075144|NCT02345161|Drug|Budesonide/Formoterol|The combination (400 mcg Budesonide/12 mcg Formoterol) will be provided as inhalation via TURBOHALER with 60 doses.
16075145|NCT02345161|Drug|Placebo to match Budesonide/Formoterol combination|The placebo (Lactose) will be provided as inhalation via TURBOHALER with 60 doses.
16075146|NCT02345161|Drug|Albuterol/salbutamol|Albuterol/salbutamol will be available as an inhalation via metered-dose inhaler (MDI) with a spacer and will be issued for reversibility testing at Visit 1 Albuterol/salbutamol MDI or NEBULES™ for as needed (prn) use throughout the study will be provided starting at Visit 1.
16075147|NCT02345148|Drug|Esketamine|Esketamine 84 mg will be self-administered by participants as intranasal spray at 0, 5 and 10 minutes on Day 1.
16075148|NCT02345135|Procedure|Blood collection|In all patients with Ataxia telangiectasia blood was collected at each visit date to determine blood count, lymphocyte subpopulation count and immunoglobulin levels in serum (IgA, IgG, IgM, IgE), as well as alpha feto protein (AFP).
16075149|NCT02345135|Procedure|Lung function measurement|In all patients - Ataxia telangiectasia and healthy controls - a lung function measurement was done to determine vital capacity (VC), forced expiratory volume in 1 second (FEV1), peak expiratory flow (PEF) and Tiffenau index.
16075150|NCT02345135|Behavioral|Symptom diary|All patients - Ataxia telangiectasia and healthy controls - were requested to keep a symptom diary for the months September to March of the years 2012/2013 and 2013/2014 to determine days with symptoms as coughing during day and night, cold and fever, as well missing days at kindergarten/school/work, intake of medication (especially antibiotic treatment) and hospitalisations.
16075151|NCT02345122|Behavioral|Intervention: Mental Health Technician|In addition to structured assessments at baseline, four, eight and twelve months (the results will be shared with their Primary Care Provider), subjects will receive psychoeducation regarding their depression, anxiety, and alcohol use disorder or at-risk drinking; symptom monitoring; and medication adherence support. Their Primary Care Provider will also be provided evidence-based recommendations regarding their treatment.
16075152|NCT02345122|Other|Enhanced Usual Care|Subjects will receive structured, quantitative assessments at baseline, four, eight and twelve months. The results will be shared with their Primary Care Provider.
16075153|NCT02345109|Device|Transtek DUT|"Measuring weight, total body water, body fat, muscle mass, bone mass, BMI, visceral fat, and calorie.
~Measure each participants by Transtek DUT."
16075154|NCT02345109|Device|Reference|Measuring weight, total body water, body fat, muscle mass, bone mass, BMI, visceral fat, and calorie. Measure each participants by Reference.
16075155|NCT02345096|Dietary Supplement|Saccharomyces cerevisiae|
16075156|NCT02345096|Dietary Supplement|Placebo|
16075157|NCT02345070|Drug|SAR156597|Pharmaceutical form: solution for injection Route of administration: subcutaneous
16075158|NCT02345070|Drug|placebo|Pharmaceutical form: solution for injection Route of administration: subcutaneous
16075159|NCT02345057|Drug|CS-3150|
16075160|NCT02345057|Drug|placebo|
16075161|NCT02345044|Drug|CS-3150|
16075162|NCT02345044|Drug|placebo|
16075163|NCT02345044|Drug|eplerenone|
16075164|NCT02345031|Drug|AUT00063|600 mg, orally, once a day, for 4 weeks
16075165|NCT02345031|Drug|Placebo|orally, once a day, for 4 weeks
16075166|NCT02345018|Procedure|Mechano-chemical ablation|Treatment with mechano-chemical ablation
16075167|NCT02345005|Device|The Gore® EXCLUDER® ILIAC BRANCH Endoprosthesis.|The Gore IBE device is a newly designed iliac branched device, that is used in combination with the widely accepted C3 Excluder endograft, for the exclusion of common iliac aneurysms and aorto-iliac aneurysms.
16075168|NCT02344992|Drug|BioChaperone insulin lispro|Single dose of 0.2 U/kg body weight injected subcutaneously
16075169|NCT02344992|Drug|Humalog®|Single dose of 0.2 U/kg body weight injected subcutaneously
16075170|NCT02344940|Drug|Toremifene|patients will take toremifene 60 mg qd.
16075171|NCT02344940|Drug|Tamoxifen|patients will take tamoxifen 10 mg bid.
16075172|NCT02344927|Other|Non-Clinically Assisted Hydration arm|Best supportive care. Continuance of oral intake (if appropriate) and regular mouth care
16075173|NCT02344927|Other|Clinically Assisted Hydration arm|Best supportive care. Continuance of oral intake (if appropriate) and regular mouth care, and clinically assisted hydration.
16075174|NCT02344914|Device|receive Laboraide|"After giving consent, randomization will be carried out using sealed envelopes. After randomization women will be offered to withdraw consent. Women assigned to the study group will receive a sealed Laboraide™ package.
~Labor follow up will be documented regularly including outcome. The use of the DSD will not affect the regular management of labor according to the routine standards of the delivery suite. Following delivery, patients will be asked to complete a satisfaction questionnaire."
16075175|NCT02344888|Drug|Clomiphene citrate and Prednisolone|Women will receive clomiphene citrate (150 mg/day for 5 consecutive days from day 2 of the cycle) and prednisolone (5 mg/day for 10 consecutive days from day 2 of the cycle)
16075176|NCT02344888|Drug|Clomiphene citrate and folic acid|Women will receive clomiphene citrate alone (150 mg/day for 5 consecutive days from day 2 of the cycle) and folic acid (0.5 mg/day for 10 consecutive days from day 2 of the cycle)
16075177|NCT02344875|Drug|FYU-981, (Oral single dosing)|
16075178|NCT02344862|Drug|FYU-981 High dose, (Oral daily dosing for 8 weeks)|Subjects randomized to the FYU-981 High dose arm receive active drug, FYU-981 High dose.
16075179|NCT02344862|Drug|FYU-981 Middle dose, (Oral daily dosing for 8 weeks)|Subjects randomized to the FYU-981 Middle dose arm receive active drug, FYU-981 Middle dose.
16075180|NCT02344862|Drug|FYU-981 Low dose, (Oral daily dosing for 8 weeks)|Subjects randomized to the FYU-981 Low dose arm receive active drug, FYU-981 Low dose.
16075181|NCT02344862|Drug|Placebo, (Oral daily dosing for 8 weeks)|Subjects randomized to the placebo arm receive placebo.
16075182|NCT02344849|Drug|mesenchymal stem cell|Patients will receive single injection of Cellgram-ED( 30,000,000 mesenchymal stem cell) intracavernously.
16075183|NCT02344836|Behavioral|Podcast + mobile diet app|Use of a mobile app to track behaviors related to weight loss as well as receive study-related weight loss information via podcast.
16075184|NCT02344836|Behavioral|Podcast + theory-based mobile diet app|Use of a theory-based mobile app to track behaviors related to weight loss as well as receive study-related weight loss information via podcast.
16075185|NCT02344823|Drug|Vardenafil|per oral intake of 10mg Vardenafil once daily
16075186|NCT02344823|Procedure|HVPG (Hepatic venous pressure measurement) baseline|HVPG measurement day 1
16075187|NCT02344823|Procedure|HVPG (Hepatic venous pressure measurement) day 7|HVPG measurement day 7
16075188|NCT02344823|Behavioral|IIEF 5 (International Index of Erectile Function) questionaire baseline|IIEF 5 questionaire to define level of erectile dysfunction at baseline
16075189|NCT02344823|Behavioral|IIEF 5 (International Index of Erectile Function) questionnaire at study phase end|IIEF 5 questionaire to define level of erectile dysfunction at end of study phase
16075190|NCT02344823|Drug|Placebo intake once daily|
16075191|NCT02344810|Drug|c-Met inhibitor AMG 337|Given PO
16075192|NCT02344810|Other|placebo|Given PO
16075193|NCT02344810|Drug|oxaliplatin|Given IV
16075194|NCT02344810|Drug|leucovorin calcium|Given IV
16075195|NCT02344810|Drug|fluorouracil|Given IV
16075196|NCT02344810|Other|pharmacological study|Correlative studies
16075197|NCT02344810|Other|laboratory biomarker analysis|Correlative studies
16075198|NCT02344797|Procedure|Remote ischemic preconditioning|The remote ischemic preconditioning procedure is carried out immediately after the induction of regional or general anesthesia. The blood pressure cuff is placed on the upper limb. The cuff is inflated to 200 mmHg resulting in a total occlusion of the blood flow to the limb. After 5 minutes of ischemia the cuff is deflated and the limb is reperfused for 5 minutes. The procedure is carried out 4 times in a row. For patients with systolic blood pressures >185 mmHg, the cuff will be inflated to at least 15 mmHg above the patient's systolic blood pressure.
16075199|NCT02344784|Device|SR-HLAB EMG|Prepulse inhibition test using SR-HLAB EMG device will record the acoustic startle response for each participant: with and without Methylphenidate treatment
16075200|NCT02344784|Drug|Methylphenidate|The regular daily dose of P.O methylphenidate of each participant will be given directly after the first prepulse inhibition test
16075201|NCT02344771|Procedure|Elective colon cancer surgery|
16075202|NCT02344758|Device|Non-invasive lateral flow test for monitoring gluten intake|
16075203|NCT02344758|Behavioral|gluten-free diet (GFD)|
16075204|NCT02344758|Behavioral|gluten-containing diet|
16075205|NCT02344745|Other|Lavandula angustifolia essential oil (Aura Cacia)|The participants will be instructed to take a deep breath while holding the towel with two drops of essential oil 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.
16075206|NCT02344745|Other|Distilled water|The participants will be instructed to take a deep breath while holding the towel with two drops of distilled water 3 inches from her face before the start of the procedure and will be instructed to continue to take normal breaths subsequently during the procedure.
16075207|NCT02344732|Drug|Dexamethasone 0.1%, Neomycin Sulfate and Polymyxin B Sulfate topical eye drops four times daily|
16075208|NCT02344732|Drug|Homatropine 2% eye drops thrice daily|
16075209|NCT02344732|Drug|Oxygen gas|
16075210|NCT02344719|Drug|Taurin 6g per day per oral for 28 days|Taurin 6g per day per oral for 28 days
16075211|NCT02344719|Procedure|HVPG Measurement baseline|On day 1 (baseline) and day 28 HVPG measurement will be performed
16075212|NCT02344719|Procedure|HVPG Measurement day 28|On day 1 (baseline) and day 28 HVPG measurement will be performed
16075213|NCT02344719|Drug|Placebo 6g per day per oral for 28 days|Placebo to Taurin 6g per day per oral for 28 days
16075214|NCT02344706|Device|Registration of EEG|EEG is registered for study purposes. No interventions to patient care is done at this stage. Acquisition is done without harming the patient.
16075215|NCT02344680|Drug|Anti-HIV Agents|
16075216|NCT02344667|Radiation|Stereotactic Body Radiotherapy|
16075217|NCT02344654|Drug|Indocyanine green|
16075218|NCT02344654|Device|Near-infrared illumination|To see the fluorescence from indocyanine green
16075219|NCT02344654|Drug|Urografin|
16075220|NCT02344654|Radiation|X-ray|
16075221|NCT02344641|Drug|Exenatide|
16075222|NCT02344628|Drug|Azithromycin|Comparison of two different dosing strategies for the treatment of yaws
16075223|NCT02344615|Procedure|NS-guided infraclavicular block|Patients received a standard single injection infraclavicular block using the lateral sagittal approach of Klaastad. The infraclavicular brachial plexus is identified using an insulated needle connected to a nerve stimulator. Placement of the needle is considered adequate if motor response of radial nerve in the hand or wrist is still present at 0.2 - 0.5mA. Ropivacaine 0.5% 35ml is used.
16075224|NCT02344615|Procedure|US-guided infraclavicular block|Infraclavicular block is performed under ultrasound guidance. Linear probe is placed in a parasagittal positon below the clavicle medial to the coracoid process and adjusted to achieve a cross-sectional image of the axillary artery. Using in-plane technique, an 22-gauge insulated needle is advanced caudally and posteriorly to the axillary artery. Subsequently, 35 ml of 0.5% ropivacaine is incrementally injected.
16075225|NCT02344602|Drug|Febuxostat|Oral tablet, 80mg, OD, 8 weeks
16075226|NCT02344589|Drug|Lidocaine|used for the active blocks
16075227|NCT02344589|Drug|Saline|used for the placebo-block
16075228|NCT02344576|Behavioral|DT LVAD Decision Support Intervention|Decision coaching and training of staff prior to intervention, to allow for additional decision support to patients and caregivers considering DT LVAD. Decision aid materials will be used with patients and caregivers.
16075229|NCT02344563|Drug|Meropem|
16075230|NCT02344563|Drug|Mepem|
16075231|NCT02344550|Drug|Everolimus(afinitor)|Everolimus 10mg p.o. daily
16075233|NCT02344550|Drug|Leuprolide(Lorelin Depot)|Leuprorelin (Lorelin Depot)3.75 mg SC in every 4 weeks
16075234|NCT02344537|Behavioral|Kundalini Yoga|Kundalini Yoga incorporates mindfulness practice with a triad of stretching, breathing, and meditation. The three components of treatment consist of muscular relaxation/stretching exercises, a meditation period characterized by a directed breathing exercise, and then a guided meditation.
16075235|NCT02344524|Device|Intercostal drainage|Small bore chest drains are inserted by modified Seldinger's technique. Large bore chest drains are inserted by blunt dissection technique.
16075236|NCT02344511|Drug|Dalbavancin|Drug
16075237|NCT02344511|Drug|cefazolin, nafcillin, oxacillin or vancomycin|Standard of Care
16075238|NCT02344498|Drug|Tenofovir disoproxil|
16075239|NCT02344485|Procedure|OMM treatment|OMM is a gentle hands-on treatment that helps to reduce myofascial restrictions and improve joint range of motion. In doing so, it can address the mechanical, neurologic, and respiratory functions of the body
16075240|NCT02344472|Drug|pertuzumab|HER2 targeted Therapy
16075241|NCT02344472|Drug|Trastuzumab|HER2 targeted Therapy
16075242|NCT02344472|Drug|Capecitabine|Chemotherapy
16075243|NCT02344472|Drug|Paclitaxel|Chemotherapy
16075244|NCT02344472|Drug|Vinorelbine|Chemotherapy
16075245|NCT02344472|Drug|Docetaxel|Chemotherapy
16075246|NCT02344472|Drug|Exemestane|endocrine therapy
16075247|NCT02344472|Drug|Letrozole|endocrine therapy
16075248|NCT02344472|Drug|Anastrozole|endocrine therapy
16075249|NCT02344472|Drug|Fulvestrant|endocrine therapy
16075250|NCT02344472|Drug|Ribociclib|CDK 4/6 inhibitor
16075251|NCT02344472|Drug|nab-Paclitaxel|chemotherapy
16075252|NCT02344472|Drug|eribulin|chemotherapy
16075253|NCT02344472|Drug|leuprorelin|endocrine therapy
16075254|NCT02344472|Drug|goserelin|endocrine therapy
16075255|NCT02344459|Device|mechanical pre-induction cervical ripening|The balloon catheters have been used to provide mechanical dilation to the cervix as a method of pre-induction cervical ripening.
16075256|NCT02344446|Other|Skilled Therapy|Active physical therapy treatment
16075257|NCT02344433|Behavioral|VICKY|Relational agent/virtual counselor
16075258|NCT02344433|Behavioral|MFHP|US Surgeon General's family history tool
16075263|NCT02344407|Biological|VSVG-ZEBOV|The VSVdeltaG-ZEBOV vaccine is comprised of a single recombinant (vesicular stomatitis virus) VSV isolate (11481 nt) modified to replace the gene encoding the G envelope glycoprotein with the gene encoding the envelope glycoprotein from the Ebola virus Zaire strain (ZEBOV)
16075264|NCT02344407|Biological|ChAd3-EBO Z|The ChAd3-EBO Z vaccine is comprised of a ChAd3 vector with a DNA fragment insert that encodes the Ebola virus glycoprotein, which is expressed on the virion surface and is critical for attachment to host cells and catalysis of membrane fusion.
16075265|NCT02344407|Biological|Placebo|
16075266|NCT02344394|Device|Medtronic Cryoballoon|For endocardial pulmonary vein Isolation, an Arctic Front Advance Cardiac CryoAblation catheter (Medtronic, Mounds view, MN, USA) will be used.
16075267|NCT02344394|Device|Thermocool Catheter|For mapping and ablation from endocardium a 3.5 mm irrigated tip catheter (Navistar Thermocool SmartTouch Unidirectional Navigation Catheter, Biosense Webster, Diamond Bar, CA, USA) will be used.
16075268|NCT02344394|Device|nContact|For Epicardial Ablation (the surgical portion of the Hybrid procedure), we will use the VisiTrax cardiac ablation device (nContact, Morrisville, NC, USA).
16075269|NCT02344381|Dietary Supplement|Sucrose|
16075270|NCT02344381|Dietary Supplement|Glucose|
16075271|NCT02344368|Other|0.2 ml sucrose 25%|Administered on the tongue by a syringe, a half dose two minutes before blood sampling and the other half dose immediately before sampling
16075272|NCT02344368|Other|0.5 ml sucrose 25%|Administered on the tongue by a syringe, a half dose two minutes before blood sampling and the other half dose immediately before sampling
16075273|NCT02344355|Drug|Temozolomide|"oral temozolomide (75 mg/m2), given 7 days per week, for a maximum of 49 days during radiation therapy.
~Starting 1 month after radiation therapy, additional temozolomide will be given as chemotherapy cycles. Each cycle is 28 days.
~For the first cycle, temozolomide will be administered (150 mg/m2) once per day for 5 days.
~If the subject tolerates the first cycle well, temozolomide will be prescribed at 200 mg/m2 for cycles 2 through 6. Each cycle is 28 days."
16075274|NCT02344355|Radiation|radiation therapy|Conformal radiation administered daily, M-F, to a total dose of 61.2 Gray in 34 fractions.
16075275|NCT02344355|Drug|Ascorbic Acid|"Intravenous infusions of 87.5g of ascorbate administered three times weekly during radiation.
~After radiation, ascorbate is administered twice weekly through the end of cycle 6 of temozolomide."
16075276|NCT02344342|Device|Telemonitoring|The Health Buddy web management system allows the patient to enter self-care data through a study provided tablet computer.
16075277|NCT02344342|Other|Flexible Diuretic Regimen|Patients will have a prescribed diuretic regimen specified by specific weight ranges.
16075278|NCT02344329|Device|Topical wound dressing|Topical Wound Dressing
16075279|NCT02344329|Biological|Human Amnion Allograft|Change dressing every two to three weeks and TCC-EZ is changed weekly for 12 or until healed.
16075280|NCT02344329|Other|usual wound care|assessment, wound cleansing, debridement, moist wound environment, and off-loading
16075281|NCT02344316|Drug|Melatonin|Taken at 9 PM or 1 hour before bedtime, whichever is earlier
16075282|NCT02344316|Other|Placebo|Matching placebo taken at 9 PM or 1 hour before bedtime, whichever is earlier
16075283|NCT02344303|Drug|TRV130|
16075284|NCT02344303|Drug|Moxifloxacin|
16075285|NCT02344303|Drug|Placebo|
16075288|NCT02344277|Device|S-ICD System (implantable defibrillator)|"The subjects will be symptomatic or asymptomatic Brugada patients with Indication for ICD replacement. Patients should be follow first at 1 month and then every 6 months according to the recent ACC/AHA/HRS guidelines60, for a period of 5 years until remote monitoring became available for S-ICD.
~Visit to 4 week post-implantation: Vital status, Clinical assessment data: weight; height; blood pressure; NYHA class, Exercise test will be performed to control sensing vectors during exercise, Electrocardiogram, Current cardiac medication, Device interrogation, Device programming, Save to USB pen drive data + Printouts Adverse events, Life quality evaluation form. Visit every 6 months post-implantation to 5 years follow-up visit: Vital status, Clinical status (e.g.NYHA) , Electrocardiogram , Current cardiac medication, Device interrogation, Device programming, Save to USB pen drive data + Printouts Adverse events, Life quality evaluation form, Current status of S-ICD system."
16075289|NCT02344264|Drug|Ropivacaine|"Arm RP is receiving 8 ml of ropivacaine 7,5 mg/ml at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with placebo (saline 8ml).
~Arm PR is receiving 8 ml of placebo (saline) at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with ropivacaine 8 ml."
16075290|NCT02344264|Drug|Saline|"Arm RP is receiving 8 ml of ropivacaine 7,5 mg/ml at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with placebo (saline 8ml).
~Arm PR is receiving 8 ml of placebo (saline) at first blockade (NCFL) and after 45 minutes another blockade (NCFL) with ropivacaine 8 ml."
16075291|NCT02344251|Device|MEMS Cap|MEMS Track Cap records when the medication bottle is opened and closed
16075292|NCT02344251|Device|ID-Cap|ID-Cap Tag is an ingestible medical device for detecting the presence of an ingested capsule inside the gastrointestinal (GI) tract.
16075293|NCT02344238|Other|ID Capsule|Capsule containing ingestible sensor
16075294|NCT02344238|Dietary Supplement|Riboflavin|50mg
16075295|NCT02344238|Behavioral|Prompts|Reminder calls and/or text messages to ingest the study medication if a signal is not sent to the study team within one hour of the scheduled medication administration time.
16075296|NCT02344225|Drug|Caffeine citrate|Caffeine citrate IV (20 mg/kg loading dose, 5 mg/kg/day maintenance dose)
16075297|NCT02344225|Drug|Ibuprofen|Ibuprofen (10 mg/kg loading dose followed by low dose ibuprofen 2.5 mg/kg/day) for 5 days
16075298|NCT02344225|Drug|Ketorolac|Ketorolac (Acuvail) eye drops (one drop two times a day) for 14 days
16075299|NCT02344212|Behavioral|ESENCIAL Para Vivir: a weight loss program for Latinas|Overweight or obese Latina immigrant women were recruited to participate an 8-week weight loss program to reduce or delay their risk of developing diabetes. Data was collected at baseline, program completion, and six months.
16075300|NCT02344186|Drug|Liraglutide|Crossover design - 24 weeks on active drug and 12 weeks daily placebo
16075301|NCT02344160|Other|Phlebotomy|Phlebotomy will be performed at study follow up visits to obtain blood for metal ion analysis which will monitor levels for safety outcome measures
16075302|NCT02344134|Biological|NBP607|0.5 mL, intramuscular, a single dose
16075303|NCT02344134|Biological|Agrippal S1|0.5 mL, intramuscular, a single dose
16075304|NCT02344121|Radiation|Radiation Therapy|Radiation therapy plans for cancer patients who have completed treatment.
16075305|NCT02344108|Device|Inspire® Upper Airway Simulation System (Model 3028 IPG )|Subjects will be implanted with a hypoglossal nerve stimulator. Safety and efficacy of implantation will be evaluated.
16075306|NCT02344095|Drug|weekly paclitaxel|Patients are treated with weekly paclitaxel 70mg/m2 (IV) on day 1, 8, and 15 at an intervals of 4 weeks
16075307|NCT02344095|Drug|weekly cisplatin|Patients are treated with weekly cisplatin 40mg/m2 (IV) on day 1, 8, and 15 at an intervals of 4 weeks.
16075308|NCT02344095|Device|oncothermia|"Thermotherapy is performed by applying oncothermia (EHY 2000) probe on the part of body where tumor is located and delivering energy. It is performed on day 1, 4, 8, 11, 15, 18, 21, and 24 (8 times in total every cycle). Oncothermia can be performed a day earlier than scheduled day or a day later than scheduled day. With tumors at multiple sites, oncothermia is performed several times changing sites that apply probe and type of probes.
~- It takes 60 minutes to treat a site for oncothermia. Energy is gradually increased from 60W to 140W."
16075309|NCT02344082|Other|Telemedicine|The intervention arm will receive pharmacy clinic visits plus additional telephone follow-up.
16075310|NCT02344069|Drug|Fibrinogen|Human fibrinogen concentrate as a injection
16075311|NCT02344069|Drug|Placebo|Saline 0.9% as a injection
16075312|NCT02344056|Other|Having lunch/skipping lunch|Lunch ad libitum on test day 1 and no lunch on test day 2. Water at libitum was constantly available on both days.
16075313|NCT02344056|Other|Skipping lunch/having lunch|No lunch on test day 1 and lunch ad libitum on test day 2. Water at libitum was constantly available on both days.
16075314|NCT02344043|Device|Near infrared spectroscopy|This device uses near infrared spectroscopy to measure tissue oxygen levels (0-100%). The sensors are placed on the subjects' forehead to measure brain tissue oxygenation
16075315|NCT02344030|Device|channeled blade|In a randomised trial we measure the time for ventilation by means of endtidale CO2 Curve
16075316|NCT02344030|Device|standard blade|In a randomised trial we measure the time for ventilation by means of endtidale CO2 Curve
16075317|NCT02344017|Drug|ODM-204|co-administered with prednisone, orally daily
16075318|NCT02344017|Drug|Prednisone|ODM-204 is co-administered with oral prednisone
16075319|NCT02344004|Drug|LAI (Liposomal Amikacin for Inhalation) 590 mg|LAI 590 mg QD, administered by inhaling drug product that had been aerosolized in an eFlow nebulizer over approximately 14 minutes.
16075320|NCT02343991|Device|Transcranial ExABlate|MR Guided Focused Ultrasound
16075321|NCT02343978|Drug|KWA-0711|
16075322|NCT02343965|Other|Touch-massage|
16075323|NCT02343952|Drug|Pembrolizumab|Pembrolizumab, 200 mg IV every 3 weeks (until PD, unacceptable toxicity, or after 12 months of therapy with pembrolizumab.
16075324|NCT02343939|Drug|Entospletinib|Tablet(s) administered orally every 12 hours
16075325|NCT02343939|Drug|Daunorubicin|60 mg/m^2 administered intravenously daily on Days 1 to 3 for up to two 14-day induction cycles
16075326|NCT02343939|Drug|Cytarabine|100 mg/m^2 administered intravenously daily on Days 1 to 7 for up to two 14-day cycles
16075327|NCT02343939|Drug|Decitabine|20 mg/m^2 administered intravenously
16075328|NCT02343939|Drug|Azacitidine|75 mg/m^2 administered intravenously or subcutaneously
16075329|NCT02343926|Drug|GEMIGLIPTIN LS15-0444|"Pharmaceutical form:tablet
~Route of administration: oral"
16075330|NCT02343926|Drug|vildagliptin|"Pharmaceutical form:tablet
~Route of administration: oral"
16075331|NCT02343926|Drug|metformin|"Pharmaceutical form:tablet
~Route of administration: oral"
16075332|NCT02343913|Device|PAC checklist|
16075333|NCT02343887|Other|neuropsychological tests|
16075334|NCT02343887|Other|STAI-Y scale for anxiety|
16075335|NCT02343887|Other|Beck scale for depression|
16075336|NCT02343887|Other|without intervention|
16075337|NCT02343874|Other|No intervention|No intervention will be done. The exposure of interest in this study is alcohol consumption in patients attended in primary health.
16075338|NCT02343861|Behavioral|Tailored leaflet group|Parents in intervention group will receive an patient education leaflet and watch an educational video about lifestyle recommendations, and the use of emollients. In addition to general information, parents in intervention group will also receive the tailored leaflet including the estimated amount of emollients based on the body surface area.
16075339|NCT02343861|Behavioral|Control group|Participants (parents of children with atopic dermatitis) in control group will receive an patient education leaflet and watch an educational video about lifestyle recommendations, and the use of emollients.
16075340|NCT02343848|Device|smart bracelet.|Physical activity will be evaluated using smart bracelet.
16075341|NCT02343835|Device|NanoKnife LEDC System|Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels and bile ducts. With IRE, multiple electrical pulses are applied to tumorous tissue. These pulses alter the existing transmembrane potential of the cell membranes, and create 'nanopores', after which the cell dies through loss of homeostasis.
16075342|NCT02343822|Other|Platelet Rich Plasma Injection|"Plasma component of blood rich in growth factors
~-during the injection, 5 needle fenestrations will be done to help stimulate blood flow to the area for healing"
16075343|NCT02343822|Other|Saline Injection|"Saline
~-during the injection, 5 needle fenestrations will be done to help stimulate blood flow to the area for healing"
16075344|NCT02343809|Other|Actual Diacutaneous Fibrolysis|Diacutaneous Fibrolysis is a non-invasive physiotherapeutic technique applied by means of a set of metallic hooks ending in a spatula with bevelled edges that allow a deeper and more precise application, which could not be achieved manually. The hook is deeply applied following the intermuscular septum between the muscles with an anatomical of functional relationship with the painful structure in order to release adherences between musculoskeletal structures.
16075345|NCT02343809|Other|Sham Diacutaneous Fibrolysis|Sham Diacutaneous Fibrolysis is applied at a superficial level. A pinch of skin was held with the thumb of the palpatory hand and the tip of the spatula, without any action taking place on the deep tissular levels.
16075346|NCT02343809|Other|Protocolized Physiotherapy|Protocolized physiotherapeutic treatment: Three weeks fo daily stretching exercises, ultrasound and analgesic electrotherapy
16075347|NCT02343796|Other|Fibreglass reinforced composite restoration-everStick|For those subjects with space availability on interocclusal distance, composite resin restorations with fibreglass reinforcement will be applied without any tooth preparation by using adhesive techniques.
16075348|NCT02343796|Device|everStick|GC, Belgium
16075349|NCT02343783|Other|Allergic Skin Reaction (ASR) Testing and Skin Blister Induction|Participants will not receive any intervention in this study. Healthy participants will be enrolled in order to allow for training on the overall skin blister induction and fluid aspiration process. The cell populations and inflammatory mediator responses in suction skin blister fluid after allergic skin reaction (ASR) in participants with atopic dermatitis (AD) or allergic asthma (AA) will be observed.
16075350|NCT02343770|Other|blood sample for identifying biomarkers|
16075351|NCT02343757|Device|PET/MRI|
16075352|NCT02343744|Drug|Guselkumab|"Participants will receive 50 milligram (mg) guselkumab subcutaneously at Weeks 0, 4 and 12. At Week 16 through the study end (Week 52) participants who are defined Very much improved or Much improved in Clinical Global Impression (CGI) will continue to receive guselkumab 50 mg every 8 weeks from Week 20 to the study end (Week 52). At each visit timing from Week 20, participants who are defined No change or Worsened in CGI will receive guselkumab 100 mg and continue 100 mg every 8 weeks dosing until the study end (Week 52). Participants who are defined Minimally improved in CGI will also receive guselkumab 100 mg only if the investigator considers that it is necessary."
16075353|NCT02343731|Other|Introduction of a dog into the home|Participants will foster dogs from the HSSA for three months while they are in the study.
16075354|NCT02343718|Drug|Vinblastine|
16075355|NCT02343718|Drug|Temsirolimus|
16075356|NCT02343705|Device|Latella Knee Implant System|
16075357|NCT02343692|Procedure|EUS guided RFA of cystic tumours of the pancreas|Endoscopic ultrasound guided radiofrequency ablation of pancreatic cysts
16075358|NCT02343679|Drug|ceritinib|Ceritinib will be administered to ALK + hematologic malignancies orally at the 750mg/day dose that has been calculated as the maximum tolerated dose in prior phase I trials in lung cancer patients. Intra patient dose reductions will be allowed for toxicities. Subjects with stable disease or better will be allowed to continue study drug until disease progression or until intolerable adverse events or patient or physician choice.
16075359|NCT02343666|Biological|C46/CCR5/P140K Lentiviral Vector-transduced Autologous HSPCs|Given IV
16075360|NCT02343666|Drug|Carmustine|Given IV
16075361|NCT02343666|Biological|Filgrastim|Given SC
16075362|NCT02343666|Other|Laboratory Biomarker Analysis|Correlative studies
16075363|NCT02343666|Drug|O6-Benzylguanine|Given IV
16075364|NCT02343666|Drug|Plerixafor|Given SC
16075365|NCT02343653|Behavioral|Nutrition and strength training|"All participants will receive professional dietary guidance and a protein supplement. At the beginning and end of the intervention every participant will be part of a program consisting of:
~Test of muscle strength, blood samples, assessment of nutritional status, MRi scan, test of Quality of life by questionnaire and test of the ammonium metabolism. After one year readmissions will by registered.
~The intervention group will receive supervised training."
16075366|NCT02343653|Behavioral|Nutrition|"All participants will receive professional dietary guidance and a protein supplement. At the beginning and end of the intervention every participant will be part of a program consisting of:
~Test of muscle strength, blood samples, assessment of nutritional status, MRi scan, test of Quality of life by questionnaire and test of the ammonium metabolism. After one year readmissions will by registered."
16075367|NCT02343627|Drug|NVXT Solution|NVXT Solution, applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.
16075368|NCT02343627|Drug|Vehicle of test product|Vehicle of test product applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.
16075369|NCT02343614|Drug|Celecoxib|
16075370|NCT02343601|Device|Photoplethysmography|Use Photoplethysmography for hemodynamic optimization during colorectal perioperative period
16075371|NCT02343588|Behavioral|The Health Lifestyles Interventions|"Creating supportive school and family environment, whole intervention periods;
~Health lifestyles educational strategies, 30min/week for education lessons and six times education activities;
~Instruct and promote school physical education, whole intervention periods;
~The monitoring and instruction of obesity related behaviors, once a week for physical activity and dietary behavioral log and once a month for parental monitor"
16075372|NCT02343575|Drug|Valproic Acid|"1.
~Start:
~VPA PO/NGT 500 mg BID
~2.
~If need to increase in 24 or more hours:
~VPA 500 mg PO/NGT q am, 1000 mg PO/NGT QHS
~3.
~If need to increase in 24 or more hours:
~VPA 500 mg PO/NGT q am, 1500 mg PO/NGT QHS
~4.If need to increase in 24 or more hours:
~VPA 500 mg PO/NGT Q am, 2000 mg PO/NGT QHS"
16075373|NCT02343575|Drug|Placebo|Placebo 500 mg matched to VPA BID PO/NGT
16075374|NCT02343575|Drug|Haloperidol|Both arms (intervention VPA and placebo) will receive flexible as needed haloperidol: Rescue: HAL IV 2-5 mg Q4hr PRN
16075375|NCT02343562|Dietary Supplement|Probiotics|Probiotics in the form of sachet will be given twice daily for a period of at least 6 months during the trial period.
16075376|NCT02343562|Dietary Supplement|Placebo|Multivitamin off-the-counter.
16075380|NCT02343536|Drug|Oral Azacitidine|
16075381|NCT02343536|Drug|Rituximab|
16075382|NCT02343536|Drug|cyclophosphamide|
16075383|NCT02343536|Drug|Vincristine|
16075384|NCT02343536|Drug|Prednisone|
16075385|NCT02343510|Other|PCR for chlamydia DNA in primary tubal cancer|PCR for presence of chlamydia DNA in paraffin blocks retrieved for tubal and ovarian tissues in all groups
16075386|NCT02343497|Dietary Supplement|Astaxanthin|
16075387|NCT02343497|Dietary Supplement|Placebo|
16075388|NCT02343484|Drug|Gelified ethanol combined to pulsed radiofrequency|Gelified ethanol (Discogel) is a sterile, implantable medical solution which is administered within the affected intervertebral disc nucleus pulposus, via a fine needle which is guided into the center of the disc, transdermally. Pulsed radiofrequency treatment is performed intradiscally for the management of chronic discogenic low back pain. The intradiscal pulsed radiofrequency is first applied and then combined to gelified ethanol injection via the same radiofrequency needle.
16075389|NCT02343484|Drug|Gelified ethanol|Gelified ethanol is a sterile, implantable medical solution which is administered within the affected intervertebral disc nucleus pulposus, via a fine needle which is guided into the center of the disc, transdermally.
16075390|NCT02343471|Dietary Supplement|20 g whey protein|
16075391|NCT02343458|Drug|GFF MDI (PT003)|Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI; PT003); Glycopyrronium and Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
16075392|NCT02343458|Drug|FF MDI (PT005)|Formoterol Fumarate Metered Dose Inhaler (FF MDI; PT005); Formoterol Fumarate Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
16075393|NCT02343458|Drug|GP MDI (PT001)|Glycopyrronium Metered Dose Inhaler (GP MDI; PT001); Glycopyrronium Inhalation Aerosol administered as 2 inhalations twice-daily (BID)
16075394|NCT02343458|Drug|Placebo MDI|Placebo (matching) for GFF MDI, FF MDI, and GP MDI administered as 2 inhalations twice-daily (BID)
16075395|NCT02343445|Drug|P-1037|P-1037 is a novel ENaC inhibitor
16075396|NCT02343445|Drug|Hypertonic Saline|4.2% saline solution
16075397|NCT02343445|Drug|Saline|0.17% saline solution
16075398|NCT02343432|Drug|Triamcinolone|Triamcinolone
16075399|NCT02343432|Drug|Epidural Volume|Epidural Volume
16075400|NCT02343432|Drug|Bupivacaine|Bupivacaine
16075401|NCT02343419|Other|Methacholine Challenge Test|"Forced oscillation technique test, plethysmography, interrupter technique test and spirometry will be performed in a row before any intervention and after inhalation of aerosols - normal saline, followed by increasing concentrations of methacholine: 0.03 mg/ml; 0.06 mg/ml; 0.125 mg/ml; 0.25 mg/ml, 0.5 mg/ml, 1 mg/ml, 2 mg/ml, 4 mg/ml, 8 mg/ml, 16 mg/ml.
~In case of FEV1 decrease of ≥ 20% of the initial value methacholine challenge test will be ceased and patient will be administered 200 µg of salbutamol in inhalation. Then, pulmonary function tests will be performed after 15 minutes."
16075402|NCT02343406|Drug|Depatuxizumab mafodotin|Adults: intravenous administration (1.25 mg/kg or 1.0 mg/kg body weight) over 30 to 40 minutes once every 2 weeks until one of the treatment withdrawal criteria was met. The dose was 1.25 mg/kg in the original protocol (Version 1) and Version 2, Amendment 1, and was lowered to 1.0 mg/kg in protocol Version 3, Amendment 2. Pediatric participants: Intravenous administration (1.0 mg/kg body weight for those who were 6 to 17 years old at the date of first dose, or 1.3 mg/kg for those who were 0 to 5 years old) over 30 to 40 minutes or as directed by the guidelines once every 2 weeks until one of the treatment withdrawal criteria was met, for a maximum of one year. If used in combination with temozolomide, depatuxizumab mafodotin was dosed on Day 1 and Day 15 of the TMZ cycle (assuming a standard regimen of 200 mg/m^2/day for 5 days of each 28-day cycle; for other TMZ schedules, timing of the depatuxizumab mafodotin dosing schedule were to be discussed with the medical monitor).
16076249|NCT02337400|Behavioral|15 minute counseling interview|
16075403|NCT02343406|Drug|Temozolomide|Capsules administered orally, 150 mg/m^2 on Days 1-5 for the first 28-day cycle, with dose escalation to 200 mg/m^2 in subsequent cycles in case of adequate tolerance until one of the treatment withdrawal criteria was met.
16075404|NCT02343406|Drug|Lomustine|Capsules administered orally, 110 mg/m^2 on Day 1 of every 42-day treatment period. Treatment continued until one of the treatment withdrawal criteria was met, for a maximum of one year.
16075405|NCT02343393|Drug|Hydralazine|
16075406|NCT02343393|Drug|Isosorbide Dinitrate|
16075407|NCT02343380|Other|calorimetric exam after a standard meal|The calorimetric and metabolic responses to identical meals (a high-protein, low-carbohydrates meal) consumed in the morning (8:00 am) and in the evening (8:00 pm) are measured in healthy volunteers, after standardizing diet, physical activity level, duration of fast and resting
16075408|NCT02343367|Behavioral|behavioral counseling|Pediatrician trained in motivational interviewing techniques provides brief lifestyle behavioral counseling to child and parent using a Healthy Lifestyle Prescription
16075409|NCT02343367|Other|Education Materials|Health education materials about healthy eating and physical activity and a community resource guide
16075410|NCT02343367|Behavioral|Face to face counseling session|30 minute face-to-face family-centered behavioral counseling session delivered by a health educator
16075411|NCT02343367|Behavioral|Text messages|regularly scheduled cell phone text messages for 12 months
16075412|NCT02343367|Behavioral|Telephone Counseling|14 telephone counseling sessions delivered by a health educator using motivational interviewing techniques. Two sessions per month for the first two months followed by one session per month for 10 months
16075413|NCT02343367|Behavioral|Newsletters|12 monthly newsletters mailed to participant homes
16075414|NCT02343354|Behavioral|Nutrition/physical activity intervention|Please see arm description
16075415|NCT02343341|Behavioral|Preschool Health Promotion Education Program|
16075416|NCT02343328|Biological|Fecal Microbiota Transplant|
16075417|NCT02343328|Biological|Placebo|
16075418|NCT02343315|Device|TENS|"Six treatment sessions will be given over two weeks. Total duration of the treatment session may last from 40 - 60 minutes.
~Equipment- TENS (CEFAR Basic TENS Machine)
~Electrodes- Four channel electrode to cover the site of pain
~Site of electrode placement- will be decided by the physical therapist to best suit or cover the area of pain based on complaints of patient based on the body chart.
~Intensity- the intensity will be increased progressively until maximum tolerable intensity is reached. This stimulation may cause visible muscle contraction. This type of current is also referred to as Motor-level TENS, which is effective for chronic pain. The intensity will not be increased beyond 25 milli Amperes if no sensation is perceived by the patient.
~Frequency- 5 Hertz
~Duration- 30 minutes"
16075419|NCT02343315|Other|SMCE|"Six sessions of supervised Motor control exercises will be provided over the period of two weeks. Exercises will be provided in order to target the function of core muscles of the spine. Each participant in the SMCE group will be trained by a physical therapist to recruit the deep muscles of the spine and reduce the activity of superficial muscles.
~Initially participants will be taught how to contract the transversus abdominis and multiﬁdus muscles in isolation from the more superﬁcial trunk muscles, but in conjunction with the pelvic ﬂoor muscles. Pressure biofeedback will be used in order to provide feedback about muscle recruitment to the participant. Exercises will be provided to the participants in the progressive manner. Later, movement of limbs will be incorporated with the contraction of the core muscles. Finally, these core muscle activation will be emphasized during the functional activities."
16075420|NCT02343315|Other|UHEP|"All the participants will receive the following treatments:
~Unsupervised home exercise program- which includes series of motor control exercises along with specific exercises including stretching exercises based on impairments.
~Education in terms of body mechanics, ergonomics advises and educational leaflet in the form of Nepali version of Back book which includes, evidence based advises about back pain self-management, advice to remain active. Treating physical therapist will educate all the participants in the first intervention session.
~Participants will not be asked to not take the over the counter analgesics including Acetaminophen or Non-inflammatory anti-inflammatory drugs (ibuprofen)."
16075421|NCT02343302|Device|Jackson-Pratt Drain|"A closed suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled suction drain"
16075422|NCT02343302|Device|Non-suctioning drainage|"A closed non-suctioning drain will be placed at the time of surgery. Patients in both arm A and arm B will receive this intervention. The patients that receive this treatment will be the ones whose envelope, selected on the basis of the texture of the gland, contains a card labelled gravity drain"
16075423|NCT02343289|Drug|Esketamine|28 mg of esketamine as a single, 40-minute, intravenous infusion on Day 1 of Period 1, 84 mg of esketamine solution as a single, oral dose on Day 1 of Period 2, 84 mg of intranasal esketamine on Day 1 of Period 3 and on Day 1 of Period 4.
16075424|NCT02343289|Drug|Clarithromycin|500 mg of clarithromycin twice daily on Days -3, -2, -1, 1, and 2 of Period 4.
16075425|NCT02343276|Drug|Nitroglycerin|Nitroglycerin (200 micrograms) + saline solution 10 ml in radial artery after sheath insertion
16075426|NCT02343276|Other|Placebo|Placebo (saline solution 10 ml) in radial artery after sheath insertion
16075427|NCT02343263|Drug|Bupivacaine|1 milliliter (mL) of 0.75% Bupivacaine Hydrochloride will be infused into 4mL of fibrin sealant (diluting the Bupivacaine HCl to 0.15%). The bupivacaine-infused fibrin sealant will then be applied to the tonsillectomy (or adenotonsillectomy) wound bed.
16075428|NCT02343263|Biological|Fibrin Sealant|Fibrin sealant will be applied to the wound bed topically as per product instructions.
16075429|NCT02343250|Drug|Cilnidipine/Valsartan|Cilnidipine 10mg/Valsartan 160mg oral on day1 of 14day cycle
16075430|NCT02343250|Drug|Cilnidipine+Valsartan|Cinidipine 10mg+Valsartan 160mg oral on day1 of 14day cycle
16075431|NCT02343250|Drug|Cilnidipine/Valsartan|Cilnidipine 10mg/Valsartan 160mg oral on day1 of 14day cycle
16075432|NCT02343250|Drug|Cilnidipine+Valsartan|Cinidipine 10mg+Valsartan 160mg oral on day1 of 14day cycle
16075433|NCT02343237|Procedure|Osteopathic treatment|osteopathic sessions of 20 minutes
16075434|NCT02343237|Procedure|Factitious osteopathic treatment|6 factitious osteopathic sessions of 20 minutes
16075648|NCT02341716|Procedure|HET|Walk advice with Nordic Poles, best medical treatment and home-based supervised exercise therapy
16075435|NCT02343224|Drug|Pegylated interferon alpha-2b|PEG-Intron 1mcg/kg/dose weekly through an injection under the skin on the same day each week
16075436|NCT02343211|Drug|Immunoglobulin|
16075437|NCT02343198|Device|Custom-built research muscle stimulator|Muscle stimulator
16075438|NCT02343185|Other|manual therapy with diaphragmatic treatment|Subjects receive five sesions of manual therapy for low back pain combined with diaphragmatic treatment.
16075439|NCT02343185|Other|Placebo treatment|Subjects receive five sesions of manual therapy for low back pain combined with a sham diaphragmatic treatment.
16075440|NCT02343172|Drug|HDM201|
16075441|NCT02343172|Drug|LEE011|
16075442|NCT02343159|Drug|dimethyl fumarate|120 mg and 240 mg delayed release capsules
16075443|NCT02343159|Device|Medication Event Monitoring System (MEMS)|The MEMS automatically compiles drug dosing history data by electronically recording the date and time of each opening of the medication container
16075444|NCT02343159|Behavioral|Adherence counseling|A telephone call to discuss adherence and individualized strategies based on data collected via smart device (i.e., LCD reader)
16075445|NCT02343146|Behavioral|Type One Training (TOT)|The intervention is comprised of a number of modes of delivery including in person, use of parent peer consultant, telephone intervention, and text messaging. The intervention is based on Social Cognitive Theory and previous work of the investigators.The focus of the intervention is on working with parents to improve child eating and physical activity behaviors as a means of improving glycemic control in very young children with type 1 diabetes.
16075446|NCT02343133|Biological|HemaMax|
16075447|NCT02343133|Drug|Placebo|
16075448|NCT02343120|Drug|BGB-3111|"In the dose-escalation part, the dose levels will be escalated following a modified 3+3 dose escalation scheme.
~In the safety, schedule and efficacy expansion part, patients will be assigned to different cohorts based on histology type."
16075449|NCT02343107|Behavioral|e-coaching|connexion to a website and interaction with an automatizes system which delivers tailored recommendations over a 4 month period.
16075450|NCT02343094|Drug|PBA 7,5g/d|Treatment for 14 days with PBA
16075451|NCT02343094|Drug|PBA 15g/d|Treatment for 14 days with PBA
16075452|NCT02343081|Drug|Temozolomide|
16075453|NCT02343081|Drug|Temozolomide|
16075454|NCT02343055|Other|Case Management and Self-Management Education|A Certified Respiratory Educator (CRE) will obtain a detailed COPD history, provide general and self-management education, and confirm a management plan with the primary care physician. Specific elements of evidence-based management are targetted for intervention. Subjects will return for a follow-up visit in-person with the interdisciplinary care team including a CRE to review their health status including COPD symptoms, exacerbation diary, symptoms, MRC scale, etc as a minimum at 3 and 12 months. Telephone follow up will occur at a minimum at 6 and 9 months.
16075455|NCT02343042|Drug|Selinexor|Oral tablets
16075456|NCT02343042|Drug|Dexamethasone|Oral tablets
16075457|NCT02343042|Drug|Lenalidomide|Oral capsule
16075458|NCT02343042|Drug|Pomalidomide|Oral tablets
16075459|NCT02343042|Drug|Bortezomib|Subcutaneous Injection (single use vial)
16075460|NCT02343042|Drug|Daratumumab|Intravenous Infusion
16075461|NCT02343042|Drug|Carfilzomib|Intravenous infusion
16075462|NCT02343042|Drug|Ixazomib|Oral capsule
16075463|NCT02343042|Drug|Elotuzumab|Intravenous infusion
16075464|NCT02343042|Drug|Clarithromycin|Tablets
16075465|NCT02343042|Drug|Belantamab Mafodotin|Intravenous infusion
16075466|NCT02343029|Other|Individualised aerobic exercise training|During the first 4 weeks of intervention two of the three weekly training sessions are offered as group training supervised by the respective qualified exercise physiologist of the Department of Sports Medicine. After 4 weeks, participants' physical performance is reassessed at the Department of Sports Medicine. If necessary, workload is readjusted to achieve the initially defined exercise intensity.
16075467|NCT02343029|Other|Waiting Control|After waiting for 12 weeks with normal daily activity, patients are allocated to a individualised aerobic exercise training, too.
16075468|NCT02343016|Device|Near-InfraRed Spectroscopy (NIRS)|NIRS is a non invasive monitoring system that enables assessment of tissue oxygenation through a quantitative estimation of haemoglobin oxygen-saturation within tissues.
16075469|NCT02343003|Device|Cooled Radiofrequency|Delivery of energy to ablate sensory nerves via cooled radiofrequency probe
16075470|NCT02343003|Drug|Corticosteroid injection|Delivery of corticosteroid into knee by injection with needle to reduce knee pain
16075471|NCT02342990|Other|Cluster B CogMed: an home-based and computer-based solution to improve working memory deficit|CogMed: an home-based and computer-based solution to improve working memory deficit
16075472|NCT02342990|Other|Cluster A No training. Delay start of CogMed|No training will be provided after T1 time point. Cluster A will start the CogMed training after the assessment at the T2 time point
16075473|NCT02342977|Drug|Placebo|Patients will randomly receive placebo
16075474|NCT02342977|Drug|Lacosamide|Patients will randomly receive lacosamide
16075475|NCT02342964|Other|Measure of hepatic elasticity|"Measure of hepatic elasticity by four non-invasive methods:
~Fibroscan, Fibrotest, SWE, MRE."
16075476|NCT02342951|Other|Lung clearance index determination|Lung clearance index determination
16075477|NCT02342938|Procedure|MEG or fMRI And INtracranial EEG|
16075478|NCT02342938|Procedure|fMRI|
16075479|NCT02342925|Other|Omnipaque 300|647 mg/mL of iohexol, equivalent to 300 mg/mL of iodine, used for assessment of glomerular function and other measure of renal function
16075480|NCT02342925|Drug|RG1662|Oral administration twice daily
16075481|NCT02342925|Drug|metformin|Single 850 mg dose of metformin
16075482|NCT02342912|Behavioral|Social Media Treatments|Each of the three intervention groups offers information that has been shown to be important for college students to have a healthy body weight. All three groups provide information on topics that we know are related to having a healthy body weight, like managing stress, keeping track of how you spend your time, and increasing self-awareness of certain health behaviors. Two of the three programs are focused on weight loss for a healthy body. The third group focuses on having a healthy mind, body and having energy during college.
16075519|NCT02342691|Drug|Placebo oral rinse|The placebo preparation will consist of formulated oral rinse without BLXA4-ME and will be identical to the test rinse in color, appearance and taste
16075483|NCT02342899|Device|Outpatient NIV Set Up using AVAPS AE (Manufactured by Philips-Respironics)|Intervention set ups will follow a standard protocol for the automated device (A40 AVAPS-AE machine;Manufactured by Philips-Respironics, Murraysville, Pittsburgh, US) and patients will be discharged with the machine and a full face mask or nasal interface. Patients will then undergo a 1-2 night home oximetry study to ensure adequate control of overnight oxygenation. Patients will be reviewed clinically as an outpatient at 6 weeks and adherence to non-invasive ventilation will be evaluated and an arterial blood gas measurement will be undertaken. A full clinical review and optimisation of NIV and interface will be performed at this visit. Patients will be reviewed at 3 months as an inpatient where overnight transcutaneous carbon dioxide level and SpO2 studies will be performed. All other patient-centred, physician-centred and healthcare utilisation measurements will be assessed at baseline, 6 weeks and 3 months.
16075484|NCT02342899|Device|Inpatient NIV Set Up using spontaneous/timed (S/T) mode pressure support ventilation (Manufactured by Philips-Respironics)|The patient will follow a specialist nurse-led protocolised set up of spontaneous/timed (S/T) mode pressure support ventilation (A40 AVAPS-AE machine; Manufactured by Philips-Respironics, Murraysville, Pittsburgh, US) using limited respiratory polygraphy, including overnight TcCO2 (Trascutaneous Carbon Dioxide) and SpO2 (Oxygen Saturation) studies. Following the inpatient set-up, patients will be reviewed as an outpatient at 6 weeks and adherence with non-invasive ventilation will be evaluated and arterial blood gas measurements will be performed. Patients will then be reviewed at 3 months as an inpatient where overnight respiratory polygraphy, TcCO2 and SpO2 studies will be repeated. All other patient-centred, physician-centred measurements and healthcare utilisation measurements will be assessed at baseline, 6 weeks and 3 months.
16075485|NCT02342886|Drug|Moxifloxacin|Oral
16075486|NCT02342886|Drug|PA-824|Oral
16075487|NCT02342886|Drug|Pyrazinamide|Oral
16075488|NCT02342886|Drug|HRZE (Rifampicin, Isoniazid, Pyrazinamide, Ethambutol combination)|Oral
16075489|NCT02342886|Drug|HR (rifampicin plus isoniazid combination tablets)|Oral
16075490|NCT02342873|Procedure|NS-guided interscalene block|Patients received a standard single injection interscalene block using the modified lateral approach of Borgeat. The interscalene brachial plexus was identified using an insulated needle connected to a nerve stimulator. An insulated needle attached to a nerve stimulator was used to identify the brachial plexus. Placement of the needle was considered adequate if the deltoid, triceps, pectoralis, or biceps muscle motor response was still present at 0.2 - 0.5mA. Ropivacine 0.75% 20ml was used.
16075491|NCT02342873|Procedure|US-guided interscalene block|Interscalene block is performed under ultrasound guidance. Linear probe is placed on the ipsilateral interscalene groove visualizing the brachial plexus located between anterior and middle scalene muscles. Using in-plane technique, an insulated needle is advanced into the brachial plexus sheath, into which 20 ml of 0.75% ropivacaine is injected
16075492|NCT02342860|Other|WASH in Schools (WinS) programme|"The intervention group will receive the UNICEF/DFAT-supported WinS programme, which consists of the following intervention package:
~Hardware: water supply system, handwashing station for group handwashing, and gender-segregated toilets with one facility accessible to students with physical disabilities;
~Software: operations and maintenance (O&M) training for teachers, hygiene training, and basic hygiene package."
16075493|NCT02342847|Other|N/A (non-interventional study)|
16075494|NCT02342834|Dietary Supplement|Small mixed protein and lipid meal|Ingestion of a small mixed protein and lipid meal 30 minutes before glucose
16075495|NCT02342808|Behavioral|Structured center-based lifestyle intervention|Participants will meet with interventionists weekly for 16 weeks and receive instruction on the DASH diet with caloric and sodium restriction and will exercise three times per week at one of the designated CR facilities, under the supervision of medically trained staff, 3 times per week for 16 weeks.
16075496|NCT02342808|Behavioral|Standard education and physician advice|Participants will receive routine medical care provided by the participants' primary care physician(s) supplemented by an educational session on hypertension management. Participants will receive a dietary consultation from the study nutritionist and an individualized exercise prescription from an exercise physiologist, but not participate in a structured program. Participants will be free to engage in diet and exercise for the 16-week intervention.
16075497|NCT02342795|Other|e-cigarette|
16075498|NCT02342795|Other|cigarette substitute|
16075499|NCT02342782|Biological|Yttrium Y 90 Basiliximab|Given IV
16075500|NCT02342782|Drug|Carmustine|Given IV
16075501|NCT02342782|Drug|Etoposide|Given IV
16075502|NCT02342782|Drug|Cytarabine|Given IV
16075503|NCT02342782|Drug|Melphalan|Given IV
16075504|NCT02342782|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo AHCT
16075505|NCT02342782|Other|Laboratory Biomarker Analysis|Correlative studies
16075506|NCT02342782|Other|Pharmacological Study|Correlative studies
16075507|NCT02342769|Drug|Dolutegravir/Abacavir/Lamivudin|Prospective, non-interventional observational study on the use of TRIUMEQ and the respective monitoring measures in the practice of HIV care in Germany. No drug will be provided. No study visits or procedures are mandated per protocol.
16075508|NCT02342756|Device|Targeting transpulmonary pressure to avoid VILI|Set different values of PEEP (CMV) and mPaw (HFOV) to obtain determined values of transpulmonary pressure (0 and 15 centimeters of water) and to determine the impact of ventilation on VILI
16075509|NCT02342743|Device|CEFALY|
16075510|NCT02342730|Behavioral|Weight Loss Specialist|Referred to a weight loss specialist
16075511|NCT02342730|Other|Quality-of-Life Assessment|Complete EORTC-QLQ questionnaires
16075512|NCT02342730|Other|Medical Chart Review|Chart reviews are performed
16075513|NCT02342717|Drug|BI 425809|single dose BI 425809 tablet
16075514|NCT02342717|Drug|Itraconazole|multiple doses of Itraconazole capsules
16075515|NCT02342717|Drug|BI 425809|single dose BI 425809 tablet
16075516|NCT02342704|Drug|natalizumab|Administered as specified in the treatment arm
16075517|NCT02342704|Drug|fingolimod|Administered as specified in the treatment arm
16075518|NCT02342691|Drug|BLXA4|BLXA4-ME is a member of a new class of chemically and metabolically stable lipoxin analogs featuring a replacement of the tetraene unit of native lipoxin-A4 (LXA4) with a substituted benzo-fused ring system. The full chemical name of the BLXA4-ME drug substance is (5S, 6R, E)-methyl 5,6-dihydroxy-8-(2-((R,E)-3-hydroxyoct-1-enyl) phenyl) oct-7-enoate.
16075520|NCT02342678|Behavioral|Yoga Therapy|
16075522|NCT02342665|Drug|Copanlisib (BAY80-6946)|Dosing is weekly for the first 3 weeks (on Days 1, 8, and 15) of a 28-day cycle, followed by a 1-week break (i.e., no infusion on Day 22).
16075523|NCT02342652|Drug|ASLAN003|Healthy subject will be randomised to receive either ASLAN003 (N-aryl substituted aminoaryloic acid derivative), which is a DHODH inhibitor developed with the aim of improving several features of teriflunomide or the matching placebo as a negative control for each dose of ASLAN003 administered.
16075524|NCT02342652|Drug|Matched Placebo|Healthy subject will be randomised to receive either ASLAN003 (N-aryl substituted aminoaryloic acid derivative), which is a DHODH inhibitor developed with the aim of improving several features of teriflunomide or the matching placebo as a negative control for each dose of ASLAN003 administered.
16075525|NCT02342639|Drug|Rifaximin|550mg pills
16075526|NCT02342639|Drug|Placebo|Placebo pill
16075527|NCT02342626|Behavioral|Dashboard|With the health care provider, subjects will use the decision dashboard to augment the discussion of treatment options.
16075528|NCT02342613|Biological|Activated PTCy-MILs|The activated PTCy-MILs will be infused through standard blood tubing containing a 170-260 micron filter without an additional leukoreduction filter into a central IV site. Each of the bags will be infused at a rate of approximately 10 ml per minute. The IV line will be flushed with normal saline immediately after completion of PTCy-MILs infusion to ensure that all product has been infused into the patient.
16075529|NCT02342600|Drug|Pazopanib|A kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma and advanced soft tissue sarcoma who have receive prior chemotherapy.
16075530|NCT02342600|Drug|Trametinib|A kinase inhibitor indicated for the treatment of patients with unresectable or metastatic melanoma with BRAF V600E or V600K mutations as detected by an FDA-approved test.
16075531|NCT02342587|Drug|Lapatinib|Patients will be treated with oral lapatinib 1250mg once daily for 21 days.
16075532|NCT02342574|Drug|F901318|Administration of active compound
16075533|NCT02342574|Drug|Placebo|Administration of placebo
16075534|NCT02342561|Device|Ioban 2 incision drape, 3M|The anterior knee of the patient is covered with an Ioban 2 drape for 75 minutes. The drape is applied and removed in accordance with product instructions.
16075535|NCT02342548|Drug|20 mg BID of PF-02545920|All subject who completed A8241021 will receive 20 mg BID (with or without titration)
16075536|NCT02342535|Behavioral|Physical Activity|Culturally tailored physical activity intervention for South Asian women and their children.
16075537|NCT02342522|Device|Remote ischemic conditioning|An automated autoRIC™ cuff will be placed on the upper arm and inflated to 200mmHg for 5 minutes and then deflated for 5 minutes, a cycle which will be undertaken 4 times in total.
16075538|NCT02342522|Device|Control|An automated autoRIC™ cuff will be placed on the upper arm and a simulated inflation and deflation protocol will be applied.
16075539|NCT02342509|Drug|Desflurane|Group A: Desflurane 5.0-6.0 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)
16075540|NCT02342509|Drug|Sevoflurane|Group B: Sevoflurane 1.4-2.1 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)
16075541|NCT02342509|Drug|Isoflurane|Group C: Isoflurane 0.9-1.2 Vol% (1.0 MAC) in Oxygen (FiO2 0.8-0.95)
16075542|NCT02342496|Dietary Supplement|Placebo|Powder
16075543|NCT02342496|Dietary Supplement|Active, only probiotics|Powder
16075544|NCT02342496|Dietary Supplement|Active, blend of berries and probiotics|Powder
16075545|NCT02342483|Dietary Supplement|MSM|
16075546|NCT02342470|Drug|Placebo|Drug : Placebo
16075547|NCT02342470|Drug|PMK-S005 1|Drug : PMK-S005 1 (50mg)
16075548|NCT02342470|Drug|PMK-S005 2|Drug : PMK-S005 2 (100mg)
16075549|NCT02342470|Drug|PMK-S005 3|Drug : PMK-S005 3 (150mg)
16075550|NCT02342457|Device|Child suspected of Hirschsprung disease|Children admitted for rectal biopsy, due to chronic constipation and suspected of Hirschsprungs disease, will undergo electrophysiological reading from the rectal inner wall, at thechosen site for biopsy before biopsy is performed. Histopathology and readings will be analyzed for corelation
16075551|NCT02342444|Drug|Enoxaparin Sodium Injection 30 mg BID|
16075552|NCT02342444|Drug|Enoxaparin Sodium Injection 40 mg QD|
16075553|NCT02342431|Device|Forced air warming compressible|Warming with a compressible forced air mattress
16075554|NCT02342431|Device|Forced air non-compressible|Warming with a non-compressible forced air mattress
16075555|NCT02342418|Drug|Tedizolid phosphate|Each group will receive a single dose of tedizolid phosphate 200 mg through a peripheral intravenous catheter.
16075556|NCT02342405|Other|80% oxygen|
16075557|NCT02342405|Other|30% oxygen|
16075558|NCT02342392|Drug|ranibizumab|Intralesional ranibizumab 0.3 mg/0.03mL injected 1 week before pterygium excision surgery.
16075559|NCT02342379|Drug|Bevacizumab|10mg/kg
16075560|NCT02342379|Drug|TH-302|670mg/m2
16075561|NCT02342366|Drug|GHB 35 mg/kg p.o.|GHB 35 mg/kg p.o.
16075562|NCT02342366|Drug|GHB 20 mg/kg p.o.|GHB 20 mg/kg p.o.
16075563|NCT02342353|Drug|Pacritinib|
16075564|NCT02342353|Drug|Erlotinib|
16075565|NCT02342340|Other|Navy Beans (cooked)|One time consumption of 3/4 cup of cooked navy beans.
16075566|NCT02342340|Other|Red Kidney Beans (cooked)|One time consumption of 3/4 cup of cooked red kidney beans.
16075567|NCT02342340|Other|Pinto Beans (cooked|One time consumption of 3/4 cup of cooked pinto beans.
16075568|NCT02342340|Other|Black Beans (cooked)|One time consumption of 3/4 cup of cooked black beans.
16075569|NCT02342340|Other|Lentils (cooked)|One time consumption of 3/4 cup of cooked lentils.
16075570|NCT02342340|Other|White Rice|One time consumption of 3/4 cup of cooked white rice.
16075571|NCT02342327|Other|switch to non-menthol cigarettes prior to cessation attempt|
16075572|NCT02342327|Other|continue smoking menthol cigarettes prior to cessation attempt|
16075573|NCT02342314|Drug|LY3143753 (Part A)|Administered via SC injection
16075574|NCT02342314|Drug|LY3185643 (Part B)|Administered via SC injection
16075575|NCT02342314|Drug|Placebo (Part A and Part B)|Administered via SC injection
16075576|NCT02342314|Drug|rGlucagon (Part B)|Administered via SC injection
16075577|NCT02342301|Behavioral|Standing Desk|Participants will be provided with a standing desk for 3 months
16075578|NCT02342301|Behavioral|Traditional Desk|Participants will use a traditional seated desk for 3 months
16075579|NCT02342288|Procedure|Head raised 10 degrees|Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. Head was raised to 10 degrees. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration.
16075580|NCT02342288|Procedure|Head in neutral position|Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration.
16075581|NCT02342275|Drug|Propranolol|Initiated at a dosage of 1 mg/kg per day divided 3 times daily for 1 week, and then increased to 2 mg/kg per day divided 3 times daily from weeks 2 to 24.
16075582|NCT02342275|Drug|Atenolol|Initiated at a dosage of 0.5 mg/kg per day in a single dose for 1 week, and then increased to 1 mg/kg per day in a single dose from weeks 2 to 24.
16075583|NCT02342262|Dietary Supplement|EcologicBarrier|multispecies probiotic product, 2x10-9 cfu/gram
16075584|NCT02342262|Other|Placebo|similar appearance as the probiotic product, but without bacteria
16075585|NCT02342249|Drug|VX-787 300 mg|A oral dose of 300 mg VX-787 tablet will be administered over 5-6 days.
16075586|NCT02342249|Drug|VX-787 600 mg|A oral dose of VX-787 600 mg (formulated as 2*300 mg tablets) will be administered over 5-6 days.
16075587|NCT02342249|Drug|Oseltamivir 75 mg|A oral dose of 75 mg Oseltamivir capsule will be administered over 5-6 days.
16075588|NCT02342249|Drug|Placebo|Subjects will receive matching placebo of Oseltamivir
16075589|NCT02342236|Device|cemented or cementless type of hip prothesis|
16075590|NCT02342223|Device|Voluma|
16075591|NCT02342210|Behavioral|Mindfulness Ambassador Council for Early Psychosis (MAC-EP)|MAC is a 12-week facilitated group mindfulness intervention promoting the development of social-emotional competence in youth created by Mindfulness Without Borders (MWB; www.mwb.org). A meditative practice, mindfulness focuses one's awareness on the present, acknowledging and accepting without judging one's feelings, thoughts, or bodily sensations. Each session has a unique focus (e.g., paying attention, practicing gratitude) and consists of facilitated group learning, discussion and mindfulness skills practice. Home assignments to help reinforce specific lesson are also assigned. Although MAC has demonstrated acceptability, feasibility, and promising beneficial effects in schools, it has yet to be implemented and/or evaluated in a clinical population. Its youth-focus and emphasis on building social and emotional competencies through mindfulness, in addition to teaching core mindfulness skills make it a promising intervention for youth recovering from their first episode of psychosis.
16075592|NCT02342197|Drug|Decapeptyl|half the dose of Gn agonist
16075593|NCT02342184|Drug|GB-0998|
16075594|NCT02342171|Other|Convalescent Plasma|Patients will be treated with plasma from recovered EVD patients.
16075595|NCT02342158|Procedure|biopsy or surgical sampling|
16075596|NCT02342158|Other|blood sampling|
16075597|NCT02342145|Drug|Basiliximab,|Basiliximab was used 10mg each time on 0d(after transplantation) and +4 d .
16075598|NCT02342145|Drug|cyclosporine A|Specifically cyclosporine A was used by intravenous drip infusion on 2mg/kg dosage from -1d and change to 5mg/kg twice oral when gastrointestinal function recovers. The blood concentrations of cyclosporine A was maintained 150-250ng/ml.
16075599|NCT02342145|Drug|Methotrexate|Methotrexate was used 15mg/m2 on +1d and 10mg/m2 on +3,+6,+11d by intravenous for prevention of graft-versus-host-disease.
16075600|NCT02342145|Drug|Mycophenolate mofetil|Mycophenolate mofetil was used 0.25g qd from 0d to 3 months for prevention of graft-versus-host-disease.
16075601|NCT02342132|Device|Non-invasive bipap ventilator|The non-invasive bipap ventilator will be used in the following respiratory treatment: bipap assisted inspiratory breaths (BAIB). The patient will be encouraged to take deep breaths at least 1.5 times greater than resting tidal volume. The pressure assistance provided by the bipap starts at 10cm H2O. Patients already on bipap will use their home settings. Starting pressure is then increased as necessary to meet the maximal inspiratory goal volume in steps of 2 up to a maximum 20cm H2O. Once the ideal pressure of support levels are established, the child will perform 3 cycles of 5 deep breaths. After each cycle the patient will pause and perform huffing and assisted coughing. The patient will be suctioned as necessary.
16075602|NCT02342132|Device|Mechanical insufflator-exsufflator|A commercial mechanical insufflator-exsufflator will be used in the following treatment: Mechanical insufflation-exsufflation (MI-E). The pressure will be administered by a face mask. The optimal pressure for the test will start at 10 cm H2O and will in crease in steps of 5 to a maximum of 25 cm H2O. The insufflation phase will take 3 seconds followed by a 2 second exsufflation phase. Three cycles of treatment will be used. Between each cycle the subject will pause and perform huffing and assisted coughing. The patient will be suctioned as necessary.
16075603|NCT02342132|Device|High frequency percussive oscillator|A commercial high frequency percussive oscillator will be used in the following treatment: combined oscillation and nebulisation. Pressures will be delivered by a face mask. At higher oscillation frequencies it is usually necessary to support the cheeks. Pressure will be gradually be increased to accustom the child to a maximum of 25cm H2O. This standard maximal pressure will ideally be used for every child. A treatment cycle will consist of 3 minutes at a frequency of 2 Hz and pressure of 15cm H2O followed by 3 minutes of 4 Hz at 20cm H2O, then 3 minutes of 5 Hz at 25cm H2O. Throughout each cycle, the patient will receive nebulized saline through the machine. After each cycle the patient will pause and perform huffing and assisted coughing. The patient will be suctioned as necessary.
16075649|NCT02341703|Drug|letrozole-metformin|letrozole 2.5 mg will be given daily from day 3 of the cycle for 5 days + metformin 500 mg three times daily continuously for 3 months unless pregnancy occurred
16075650|NCT02341703|Drug|letrozole-metformin-pioglitazone|letrozole will be given daily from day 3 of the cycle for 5 days + (metformin 850 mg + pioglitazone 15 mg) from the first day of the cycle for 10 days.
16076250|NCT02337387|Biological|Blosozumab|Administered SC
16075604|NCT02342119|Other|Talking About Living Kidney Donation|TALK participants receive a culturally sensitive educational booklet and video. A study interventionist encourages participants to share the materials with their family members or friends. Materials provide information to encourage patient and families shared and informed consideration of LDKT, including: 1) information about eligibility for LDKT, 2) the clinical evaluation required for LDKT, 3) the donor selection process, 4) surgical procedures for transplantation and donation, 5), and concerns brought forth about these factors, identified through structured group interviews.
16075605|NCT02342119|Other|Kidney Transplant Fast Track|KTFT is a one-day streamlined transplant evaluation process. Every patient who is evaluated at the University of Pittsburgh Starzl Transplant Center receives the KTFT. This approach involves completion of most or all testing on the same day that patients arrive for their first pre-transplant clinic appointment, rather than providing them with a list of tests they complete on their own with their referring physician. If patients are unable to be scheduled the same day, the transplant clinic scheduler secures appointment times and preparatory material for all testing to be completed within a 2 week period.
16075606|NCT02342093|Drug|30EE+DRSP|Combined oral contraceptive containing 30 mcg of ethinylestradiol + 3 mg of drospirenone (30EE+DRSP), 1 pill once a day with a pause of seven days between the blisters for 6 months
16075607|NCT02342093|Drug|20EE+DRSP|Combined oral contraceptive containing 30 mcg of ethinylestradiol + 3 mg of drospirenone (20EE+DRSP), 1 pill once a day with a pause of four days between the blisters for 6 months
16075608|NCT02342080|Other|Training sessions|A group with spinal cord injury will be trained in a 30-minute session 5 times weekly for 6 weeks. Each session will be supervised by qualified staff. Patients will undergo training with gradual increase in load and speed, according to the tolerance of each patient. The body weight support progression will start at 50 % of the patient body weight. It will be changed every 2 weeks and the load will decrease 10%. The progression of speed may be accompanied during the training period.
16075609|NCT02342080|Device|Lokomat system (Hocoma AG Switzerland)|For the robot locomotion therapy, the Lokomat system (Hocoma AG Switzerland) will be used.
16075610|NCT02342067|Drug|Cenicriviroc|CVC 150 mg QD on Days 1-10, washout on Days 11-20, PGZ 45 mg QD on Days 21-30, and CVC 150 mg QD + PGZ 45 mg QD on Days 31-40
16075611|NCT02342067|Drug|Pioglitazone|PGZ 45 mg QD on Days 1-10, washout on Days 11-20, CVC 150 mg QD on Days 21-30, and CVC 150 mg QD + PGZ 45 mg QD on Days 31-40
16075612|NCT02342054|Radiation|MRI-TRUS fusion guided Single Frac HDR|
16075613|NCT02342041|Drug|SUVN-G3031|
16075614|NCT02342041|Drug|Placebo|
16075615|NCT02342028|Biological|OSA|This study aims to compare the difference in the number and function of regulatory T cells between OSA patients and controls. The investigators will draw peripheral venous blood samples from both groups and measure the number and function of their regulatory T cells. However, some, NOT ALL, of OSA patients may receive continuous positive airway pressure (CPAP) treatment-the standard therapy for severe-to-moderate OSA. Use of CPAP is based on physician's suggestion and patients' decision, but not for this study. The devices are provided by patients themselves and its type/brand is not limited or prespecified. For those with CPAP therapy, their blood sample will be re-collected 26 weeks later to repeat measurement for subgroup analysis.
16075616|NCT02342015|Drug|Atorvastatin|Atorvastatin 40mg/day for three months
16075617|NCT02342002|Drug|Mifepristone|Mifepristone for treatment of missed abortion
16075618|NCT02342002|Drug|Misoprostol|Misoprostol for treatment of missed abortion
16075619|NCT02341989|Drug|Bleomycin Etoposide and Cisplatin|
16075620|NCT02341989|Drug|Carboplatin|
16075621|NCT02341976|Other|Vibratory platform exercises|Different positions on vibratory platform with different frequencies
16075622|NCT02341963|Drug|Oral Ketamine|Oral ketamine (Ketamine HCL injection, 100 mg/ml, USP, Hospira)
16075623|NCT02341950|Behavioral|SCI Hard|The game SCI Hard is designed to enhance self-management skills in individuals with spinal cord injury
16075624|NCT02341937|Other|Diagnostic tests for suspected deep vein thrombosis|Pre-test clinical probability (Wells score), D-dimer, compression ultrasonography
16075625|NCT02341924|Other|Portfolio of functional foods|
16075626|NCT02341924|Other|Control foods|
16075627|NCT02341911|Drug|Gemcitabine,cisplatin|Gemcitabine 1250 mg/m2, IV drip 30 minutes, D1, D8 Cisplatin 75 mg/m2, IV drip 120 minutes, D1
16075628|NCT02341911|Drug|Gemcitabine,carboplatin|Gemcitabine 1000 mg/m2, IV drip 30 minutes, D1, D8 Carboplatin AUC 2, IV drip 120 minutes, D1
16075629|NCT02341898|Other|Educational programme for all nurses|
16075630|NCT02341898|Other|Training and structured support for nominated key nurses|
16075631|NCT02341898|Other|Facultative train-the-trainer module for key nurses|
16075632|NCT02341898|Other|Printed study material|
16075633|NCT02341898|Other|Supportive material (poster, mugs etc.)|
16075634|NCT02341872|Other|Clinpro White Varnish (fluoride + calcium varnish)|Clinpro White Varnish will be applied to the teeth with brush.
16075635|NCT02341872|Other|Curodont Repair|Curodont Repair solution be applied to the teeth in the form of drops
16075636|NCT02341859|Device|stenfilcon A|contact lens
16075637|NCT02341859|Device|delefilcon A|contact lens
16075638|NCT02341859|Device|narafilcon A|contact lens
16075639|NCT02341846|Other|Qualitative interviews|
16075640|NCT02341833|Drug|Sevoflurane|In the sevoflurane group, the anesthetic agent has to be administered immediately after arrival in the operating room to reach an end-expiratory target concentration of 2%. This concentration of sevoflurane should be maintained until the procedural cardiac arrest and for at least 15 min.
16075641|NCT02341807|Biological|AAV2-hCHM|Comparison of different dosages of AAV2-hCHM
16075642|NCT02341794|Drug|Rosuvastatin|Rosuvastatin (5mg) will be orally administrated once daily. Dose of rosuvastatin will be adjusted to control serum LDL-c level under 1.8 mmol/L.
16075643|NCT02341768|Device|ICD|ICD single, dual or triple chamber, upgrade, replacement or primo implant
16075644|NCT02341742|Device|multiple examinations|biological,clinical, X-ray, DXA, accelerometry assessment
16075645|NCT02341729|Drug|ticagrelor|crushed tablets and non-crushed tablets
16075646|NCT02341716|Procedure|WA|Walk advice with Nordic Poles and best medical treatment
16075647|NCT02341716|Procedure|SET|Walk advice with Nordic Poles, best medical treatment and hospital-based supervised exercise therapy
16075651|NCT02341703|Radiation|transvaginal ultrasound|transvaginal ultrasound will be done from day 10 of the cycle and every other day for monitoring of follicular enlargement.
16075652|NCT02341703|Other|laboratory investigations|day 3: FSH, LH, TSH, and total testosterone day 12 serum E2 day 21 serum progesterone
16075653|NCT02341690|Other|Interval walking training|"Interval Walking Training with the InterWalk Application An Interval-walking bout will consist of repeated cycles of 3 minutes of fast and 3 minutes of slow walking at 70% and 40% of the smart-phone assessed peak VO2-rate, respectively.
~IWT is conducted for at least 60 minutes per day, three days per week. Compliance is monitored continuously using the on-board accelerometer logger"
16075654|NCT02341690|Other|control|Standard care at the promotion centre in the municipality
16075655|NCT02341677|Procedure|SmartTarget - Biopsy|MRI to ultrasound fusion guided prostate biopsy
16075656|NCT02341651|Other|Multicomponent intervention|Multicomponent intervention is a combination of the following 1) community health worker (CHW)- led blood pressure (BP) screening and referral to provider, plus 2) home health education (HHE) adapted to the local diet by trained CHW plus 3) trained primary health center mid-level providers (MLP) and physicians using evidence-based treatment algorithm of BP lowering in all and lipid lowering for high risk, plus 4) process-based incentives
16075657|NCT02341638|Drug|BMS-986141|
16075658|NCT02341638|Drug|Placebo|
16075659|NCT02341638|Drug|Aspirin|
16075660|NCT02341638|Drug|Itraconazole|
16075661|NCT02341625|Drug|BMS-986148|
16075662|NCT02341625|Biological|Nivolumab|
16075663|NCT02341612|Other|single exposure at 5°C in CWI|The subjects of this group performed cold water immersion immediately after exercise-induced muscle damage (EIMD) a single exposure at 5°C for 20 minutes.
16075664|NCT02341612|Other|single exposure at 15°C in CWI|The subjects of this group performed CWI immediately after EIMD a single exposure at 15°C for 20 minutes.
16075665|NCT02341612|Other|multiple exposures at 10°C in CWI|The subjects of this group performed CWI immediately, 24h, 48h and 72h after EIMD (once a day) for 20 minutes.
16075666|NCT02341612|Other|whole body cryotherapy (WBC)|The whole body criotherapy (WBC) group remained in the cabin immediately after EIMD for 3 minutes.
16075667|NCT02341612|Other|passive recovery|The control group was exposed to treatment after the EIMD protocol.
16075668|NCT02341599|Drug|MK-6183|MK-6183 (CB-238,614) is supplied as lyophilized powder 500 mg vial and mixed into solution for 100 mL intravenous (IV) administration over 1 hour.
16075669|NCT02341586|Other|Lucky Iron Fish - home fortification system|The Lucky Iron Fish (LIF) is an ingot used during cooking as an in-home fortification system of iron. The LIF works on the same principle as cast iron pots and pans by increasing dietary intake of iron but is small and lightweight. The LIF was designed in collaboration with village elders and community members to ensure it would be accepted in Cambodia. The iron ingot resembles a local fish believed to be lucky among villages in Cambodia, contributing to the acceptability of the ingot.
16075670|NCT02341586|Dietary Supplement|18 mg elemental iron|This dose of iron is the recommend dietary allowance (RDA) for iron for this cohort. Women will receive one-on-one instructions on how best to consume their tablet (for example, with food).
16075671|NCT02341586|Other|Nutrition Education|This group will receive education containing key messages around anemia, malaria, iron intake, and dietary diversity.
16075672|NCT02341573|Drug|experienced chinese herbal formulas|At the acute stage of asthma :Shegan mixture ; At the remission stage:Huangqi Bushen mixture; 10-30 mL , 2 times a day, for 3 months.
16075673|NCT02341573|Drug|leukotriene receptor antagonist and bronchial relaxant|At the acute stage of asthma : etinoline,twice a day for 7 days; At the remission stage: Singulair, once daily for 3 months.
16075674|NCT02341560|Drug|QPI-1007 Injection - 1.5 mg|
16075675|NCT02341560|Drug|QPI-1007 Injection - 3.0 mg|
16075676|NCT02341560|Other|Sham Injection Procedure|Sham Procedure
16075677|NCT02341547|Drug|a Biosimilar Epoetin Alfa|End Stage Renal Failure patients stable on Eprex switched to Binocrit
16075678|NCT02341534|Device|BioMonitor|Patients will be implanted with the BioMonitor + standard of care
16075679|NCT02341521|Drug|OC000459|Taken orally for 8 days
16075680|NCT02341508|Biological|0.5 mg/kg Lpathomab|
16075681|NCT02341508|Biological|1.0 mg/kg Lpathomab|
16075682|NCT02341508|Biological|3.0 mg/kg Lpathomab|
16075683|NCT02341508|Biological|10 mg/kg Lpathomab|
16075684|NCT02341508|Biological|20 mg/kg Lpathomab|
16075685|NCT02341508|Other|Saline solution for intravenous infusion|
16075686|NCT02341495|Drug|Deferasirox|Deferasirox (20mg/kg/day)on days 1-7 of protocol every 4 wks for 8 cycles PO
16075687|NCT02341495|Drug|Cholecalciferol|Cholecalciferol(4,000 units/day) on days 1-7 of protocol every 4 wks for 8 cycles PO
16075688|NCT02341495|Drug|Azacitidine|Azacitidine (75mg/m2 subcutaneous or IV administration) on days 1-7 of protocol 28 days for 32 wks
16075689|NCT02341482|Drug|PF-04958242|Administered as specified in the treatment arm
16075690|NCT02341482|Drug|Itraconazole|Administered as specified in the treatment arm
16075691|NCT02341469|Other|integrated ediagnostic approach (IeDA)|"IeDA is a package of several interventions with the objective of improving the quality of child health care in health centres to ultimately decrease child morbidity and mortality. The components of IedA are described as follows:
~REC: the IMCI protocol translated into a computer-based tool that aims to guide nurses during consultations.
~The training of nurses on IMCI and REC.
~A quality assurance mechanism through which each district and health centre is encouraged to find appropriate solutions in response to their local needs.
~A supervision system conducted implemented by district managers to provide support and guidance to health centres.
~A health information system based on data collected through the REC and fed back to the district managers and Heads of health centres."
16075692|NCT02341456|Drug|AZD1775|AZD1775 is a highly selective, adenosine-triphosphate (ATP) competitive, small-molecule inhibitor of the WEE1 kinase that sensitizes tumour cells to cytotoxic agents and is being developed for the treatment of advanced solid tumours and p53 pathway deficient malignancies. Gemcitabine is a nucleoside analog used as chemotherapy.
16075693|NCT02341456|Drug|Paclitaxel|Paclitaxel is a mitotic inhibitor used in cancer chemotherapy ; it and docetaxel represent the taxane family of drugs.
16075795|NCT02340598|Other|cold vest|The lowering of body temperature increases basal metabolic rate
16076251|NCT02337387|Other|Placebo|Administered SC
16075694|NCT02341456|Drug|carboplatin|Carboplatin is a chemotherapy drug used against some forms of cancer (mainly ovarian carcinoma, lung, head and neck cancers as well as endometrial, esophageal, bladder, breast and cervical; central nervous system or germ cell tumors; osteogenic sarcoma, and as preparation for a stem cell or bone marrow transplant.).
16075695|NCT02341443|Procedure|Implants|"Experimental arm: Rigid
~Surgical treatment using arch bars and according to the following fixation:
~Rigid fixation on one side (most anterior fracture) and non-rigid fixation on the other (most posterior fracture).
~Active comparator: Non-rigid
~Surgical treatment using arch bars and according to the following fixation:
~Non-rigid fixation on both fracture sides.
~Whereas non-rigid fixation is defined as a single miniplate of ≤1.00 mm thickness, and rigid fixation is defined as a single plate of ≥1.25 mm thickness, a combination of 2 plates or a 3D geometric plate."
16075696|NCT02341430|Device|Symbotex™ Composite Mesh|Repair of a Grade I or II ventral hernia according to VHWG classification system with Symbotex™ Composite Mesh
16075697|NCT02341417|Drug|Cinacalcet|Cinacalcet was provided as 5 mg capsules for sprinkling or as 30 mg film-coated tablets for swallowing. The protocol-specified doses were: 1, 2.5, 5, 7.5, 10, 15, 30, 60, 90, 120, and 180 mg.
16075698|NCT02341404|Drug|2-hydroxyflutamide (2-HOF)|Two components are mixed, transferred to a syringe and administered with injection into the prostate
16075699|NCT02341391|Biological|TissueGene-C(Low dose)|3.0 x 10^6 cells
16075700|NCT02341391|Biological|TissueGene-C(Medium dose)|1.0 x 10^7 cells
16075701|NCT02341391|Biological|TissueGene-C(High dose)|3.0 x 10^7 cells
16075702|NCT02341378|Biological|TissueGene-C(Low dose)|TissueGene-C at 6.0x10^6 cells
16075703|NCT02341378|Biological|TissueGene-C(High dose)|TissueGene-C at 1.8x10^7 cells
16075704|NCT02341365|Other|vitamin D,AMH, AFC, reproductive outcome egg recipients|observational study of 269 donnors
16075705|NCT02341352|Drug|fluoride varnish|Sodium fluoride 50mg/ml
16075706|NCT02341352|Biological|Immunoglobulin Yolk|anti-Streptococcus mutans IgY
16075707|NCT02341352|Dietary Supplement|Probiotics|2g/day，Lactobacillus rhamnosus HN001, Bifidobacterium lactis Bi-07, Bifidobacterium lactis HN019, maltodextrin, fructose, skimmed milk powder
16075708|NCT02341339|Procedure|Laparoscopic Surgery (Biopsies of fallopian tube lumen) using a laparoscopic brush/biopsy device|
16075709|NCT02341300|Device|Cast Iron Pot|Cast iron pot
16075710|NCT02341300|Device|Alumnium Pot|Aluminum Skillet
16075711|NCT02341287|Device|Warming hydrogel device|Patients will wear a warming hydrogel glove in the second two week period. Also a actigraph to monitor sleep latency.
16075712|NCT02341287|Device|Non thermal hydrogel device|Patients will wear a hydrogel glove in the second two week period. Also a actigraph to monitor sleep latency.
16075713|NCT02341274|Drug|Tacrolimus|Bioequivalence study
16075714|NCT02341261|Behavioral|Standard Care Counseling|
16075715|NCT02341261|Behavioral|Supervised Exercise and Counseling|
16075716|NCT02341248|Other|Exclusive Enteral Nutrition (EEN)|8 week standard course of treatment with EEN
16075717|NCT02341235|Behavioral|Game intervention|The game will target motivation via narrative and game mechanics. It will also encourage self-regulation by providing monitoring and feedback of activity. Counseling will be adapted to specifically reference concepts related to narrative and games.
16075718|NCT02341235|Behavioral|Standard intervention|The electronic activity monitor will monitor steps, and the mobile device will provide basic feedback on progress toward goals. Counseling will be standard and concentrate on self-regulatory skill-building.
16075719|NCT02341222|Device|BP self-standing felt device|BP device will be implanted under fascia group-A, operated subjects. A lumbar 4-5 cm incision will be performed, splaying of the skin and subcutaneous layers, then will be incised the fascia plane, with a blunt dissection the fascia will be separated from muscles. Fifteen rats will receive 2x2cm2 samples of BP (Buckypaper) in a pocket created between muscular fascia and large muscles. The rough opaque surface will face the muscle surface and the smooth brilliant surface will face the lower muscular fascia surface, without fixation with stitches. Then the scar will be sutured with absorbable stitches on the fascia incision edge and not absorbable stitches on the skin.
16075720|NCT02341222|Device|PR Parietene mesh device|Fifteen rats (hereafter defined as BPR16-BPR30 B-group control subjects) will receive 2x2cm2 samples of PP (polypropylene) in a pocket created between muscular fascia and large muscles. A lumbar 4-5 cm incision will be performed, splaying of the skin and subcutaneous layers, then will be incised the fascia plane, with a blunt dissection the fascia will be separated from muscles. Fifteen rats (hereafter defined as BPR16-BPR30) will receive 2x2cm2 samples of PP (polypropylene) in a pocket created between muscular fascia and large muscles. The polypropylene prosthesis will be fixed to the muscle with absorbable sutures surface and then the muscular fascia will be sutured over the prosthesis, with absorbable stitches on the fascia. Not absorbable stitches will be sutured on the skin.
16075721|NCT02341209|Drug|Doxycycline monohydrate|Doxycycline will be administered in either tablets or capsules for either five months or a year depending on response.
16075722|NCT02341196|Procedure|CEA|Patients in both groups received an intra-operative angiography
16075723|NCT02341183|Device|tPAD|7% NaCl administered continuously for 8 hours, overnight, via the tPAD device
16075724|NCT02341183|Device|7% hypertonic saline (510K approved as a device)|Subjects will receive overnight treatments of 7% HS via the tPAD device in both comparators, but in a randomly assigned order as described.
16075725|NCT02341170|Radiation|HS-PCI|Hippocampal-sparing prophylactic cranial irradiation with 25 Gy in 10 fractions
16075726|NCT02341144|Procedure|Pre-op percutaneous rectus sheath block|After induction of anesthesia, the attending anesthesiologist will use a portable ultrasound probe to locate the rectus sheath. A 22 gauge needle will be used to inject a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10cc, divided into equal doses bilaterally). The analgesic will be injected percutaneously using ultrasound guidance between the rectus abdominis muscle and the posterior rectus sheath at the lateral border bilaterally.
16075727|NCT02341144|Procedure|Intra-operative rectus sheath block|After the completion of the umbilical hernia repair, after fascial closure, but prior to skin closure, a predetermined volume of 0.2% ropivacaine (1cc/kg, max dose 10c, divided into equal doses bilaterally) will be administered under direct visualization into the rectus sheath bilaterally by the attending surgeon.
16075728|NCT02341144|Drug|Ropivacaine|
16076252|NCT02337374|Device|Midurethral sling mesh|
16075729|NCT02341131|Behavioral|Cognitive Remediation Therapy|The program has a duration of 40 sessions (one hour of duration), with two sessions for week during four months. It is carried out individually and utilizes paper and pencil tasks. The main technique utilized is the scaffolding (to provide strategies when the patient cannot carry out the task and to withdraw him when he is yet able of doing it alone) in a context of learning without errors.
16075730|NCT02341131|Behavioral|Psychoeducation|The program has a duration of 40 sessions (one hour of duration), with two sessions for week during four months. It is carried out individually and utilizes teaching information and coping skills and neuropsychological issues are not addressed.
16075731|NCT02341118|Genetic|BRCA genetic data|Two blood samples will be taken which is part of the standard of care. Tumor samples will be obtained from previous biopsy or surgery prior to this study for DNA testing
16075732|NCT02341105|Procedure|Catheter ablation|Pulmonary vein isolation by catheter ablation
16075733|NCT02341105|Drug|Amiodarone|antiarrhythmic therapy using Amiodarone
16075734|NCT02341092|Behavioral|Traumatic brain injury|Collection of the use of expertise relatives of victims of traumatic brain injury
16075735|NCT02341079|Drug|Bupivacaine Liposome Injection|Intraoperative intracapsular injection of 266mg of bupivacaine liposome injection diluted to 60mL with 0.9% normal saline.
16075736|NCT02341079|Drug|Indwelling femoral nerve block|Femoral nerve block delivered via indwelling femoral nerve catheter with 0.125% bupivacaine.
16075737|NCT02341066|Device|Endothelial Dysfunction evaluation by EndoPAT|Endothelial dysfunction will be measured assessing reactive hyperemia of digital arteries by using Endo-PAT2000 (Itamar, Israel).
16075738|NCT02341053|Other|Assisted Standing Treatment Program|Assisted Standing Treatment Program - Assisted standing treatment program will be gradually increase duration of standing by up to 75% after baseline.
16075739|NCT02341027|Device|Jadelle|within 5 days of delivery and before discharge from hospital
16075740|NCT02341027|Device|Jadelle|6-8 weeks (42-56 days) postpartum
16075741|NCT02341014|Drug|Carfilzomib|The initial dose of carfilzomib (cycle 1, day 1) given to any patient regardless of dose level must be 20mg/m2 . All subsequent doses of carfilzomib will be based on the patient's dose level.
16075742|NCT02341014|Drug|Romidepsin|
16075743|NCT02341014|Drug|Lenalidomide|
16075744|NCT02341001|Other|Daily text message of support|
16075745|NCT02340988|Drug|Single-Dose IV Oritavancin Diphosphate and Warfarin|Oritavancin will be administered as a single IV infusion simultaneously with Warfarin. The infusion will last approximately 3 hours.
16075746|NCT02340988|Drug|Single-Dose IV Oritavancin Diphosphate and Warfarin 24 hour post dose|Oritavancin will be administered as a single IV infusion and 24 hours post dose subjects will receive 25mg of Warfarin. The infusion will last approximately 3 hours.
16075747|NCT02340975|Biological|MEDI4736 + tremelimumab|MEDI4736 will be administered by IV infusion in combination with tremelimumab.
16075748|NCT02340975|Biological|MEDI4736 + tremelimumab|MEDI4736 will be administered by IV infusion in combination with tremelimumab.
16075749|NCT02340975|Biological|MEDI4736|MEDI4736 will be administered by IV infusion.
16075750|NCT02340975|Biological|Tremelimumab|Tremelimumab will be administered by IV infusion.
16075751|NCT02340975|Biological|MEDI4736+tremelimumab|MEDI4736 will be administered by IV infusion in combination with tremelimumab.
16075752|NCT02340975|Biological|MEDI4736 + tremelimumab|MEDI4736 will be administered by IV infusion in combination with tremelimumab.
16075753|NCT02340962|Drug|TG-2349|TG-2349 (Furaprevir) is available as a Swedish orange capsule (size 0) for oral administration. Each capsule contains an equivalent of 100 mg of TG-2349 spray dried solid (SDD) and the following inactive ingredients: microcrystalline cellulose, croscarmellose sodium, sodium lauryl sulfate, magnesium stearate, and colloidal silicon oxide.
16075754|NCT02340962|Drug|Ribavirin|RBV (Ribavirin or COPEGUS®) is available as a light pink to pink colored, flat, oval-shaped, film-coated tablet for oral administration. Each tablet contains 200 mg of ribavirin and the following inactive ingredients: pregelatinized starch, microcrystalline cellulose, sodium starch glycolate, cornstarch, and magnesium stearate. The coating of the tablet contains Chromatone-P® or Opadry® Pink (made by using hydroxypropyl methyl cellulose, talc, titanium dioxide, synthetic yellow iron oxide, and synthetic red iron oxide), ethyl cellulose (ECD-30), and triacetin.
16075755|NCT02340962|Drug|Interferon Alfa-2a|"IFN (Interferon, Peg-interferon alpha-2a or PEGASYS®) is available as a sterile, preservative-free, colorless to light yellow injectable solution administered subcutaneously.
~Each prefilled syringe of 180 μg/0.5 mL IFN (expressed as the amount of interferon alfa-2a) also contains acetic acid (0.0231 mg), benzyl alcohol (5 mg), polysorbate 80 (0.025 mg), sodium acetate trihydrate (1.3085 mg), and sodium chloride (4 mg) at pH 6 ± 0.5."
16075756|NCT02340949|Drug|Aflibercept|Administered I.V. at doses of 4 mg/Kg on Day 1 every 14 days. It will be supplied to sites by Sponsor as 4 ml vials at a concentration of 25 mg/ml
16075757|NCT02340949|Drug|5-Fluoruracil|Once every 14 days. Day 1: 400 mg/m2 I.V. bolus and a 46 h infusion of 5-FU 2400 mg/m2
16075758|NCT02340949|Drug|Oxaliplatin|Once every 14 days. Day 1: 85 mg/m2 I.V. infusion in 250-500 mL, over two hours, followed by 5-FU
16075759|NCT02340949|Drug|Leucovorin|Once every 14 days. Day 1: 200 mg/m2 I.V., over two hours, followed by 5-FU
16075760|NCT02340936|Drug|LR-ESHAP (lenalidomide 5 mg)|3 cycles of lenalidomide 5mg, etoposide, methylprednisolone, cisplatin, cytarabine and rituximab every 3 weeks.
16075761|NCT02340936|Drug|LR-ESHAP (lenalidomide 10 mg)|3 cycles of lenalidomide 10mg, etoposide, methylprednisolone, cisplatin, cytarabine and rituximab every 3 weeks.
16075762|NCT02340936|Drug|LR-ESHAP (lenalidomide 15 mg)|3 cycles of lenalidomide 15mg, etoposide, methylprednisolone, cisplatin, cytarabine and rituximab every 3 weeks.
16075763|NCT02340936|Drug|LR-ESHAP (lenalidomide 20 mg)|3 cycles of lenalidomide 20mg, etoposide, methylprednisolone, cisplatin, cytarabine and rituximab every 3 weeks.
16075764|NCT02340910|Procedure|Short Duration|During each WBV repetition, subjects will stand on the vibration platform of the WBV device with knees slightly bent (approximately 30 degrees flexion). The subject will hold the handrails for balance and the WBV device will be turned on. The subject will receive a total of 6 minutes of WBV at a frequency of 50 Hz.
16075874|NCT02340052|Drug|Pain treatment|Registration af actual analgesic treatment and outcomes
16075765|NCT02340910|Procedure|Long Duration|"During each WBV repetition, subjects will stand on the vibration platform of the WBV device with knees slightly bent (approximately 30 degrees flexion). The subject will hold the handrails for balance and the WBV device will be turned on. The subject will receive a total of 12 minutes of WBV at a frequency of 50 Hz.
~Interventions will occur for a total of 20 sessions over 4 consecutive weeks ."
16075766|NCT02340884|Behavioral|Promoting Resilience In Stress Management (PRISM)|"The brief format of the PRISM intervention involves 4, 50-minute, one-on-one sessions approximately 2 weeks apart, plus a 5th parent-inclusive session 2-4 weeks following session #4. These are complimented with age-specific handouts describing the skills and opportunities to practice them, as well as weekly (text- or email based) check-ins from study staff and in-person booster sessions once monthly. Specifically, the intervention incorporates four primary skills: 1) stress management/mindfulness; 2) goal-setting; 3) cognitive restructuring; and, 4) meaning-making/benefit finding."
16075767|NCT02340871|Genetic|Genetic testing|Patients suspected of harboring a genetic neurological disease will be summoned to take a blood test. DNA will be extracted from the blood and sent to the collaborating hospital labs for next generation sequencing.
16075768|NCT02340858|Device|NanoKnife LEDC System|Irreversible electroporation (IRE) is a method to induce irreversible disruption of cell membrane integrity (loss of cell homeostasis) resulting in cell death without the need for additional pharmacological injury. Because IRE is a non-thermal technique, changes associated with perfusion-mediated tissue cooling (or heating) are not relevant. While cells in the ablation region are destroyed, the underlying extracellular matrix is not damaged thus allowing tissues in the ablation zone to heal normally.
16075769|NCT02340845|Biological|Bromelain and Comosain|Treatment of solid tumors in advanced stage of lung, breast, colon, ovary, cervix, uterus, prostatic, and liver
16075770|NCT02340819|Drug|Teduglutide|0.05 mg/kg/day administered by subcutaneous injection over a 24-week period.
16075771|NCT02340806|Device|CADD-Solis pump (Smiths Medical)|The maintenance epidural solution for both groups will be bupivacaine 0.625 mg/mL with fentanyl 1.95 mcg/mL. The intermittent bolus volume will be 10 mL administered every 60 minutes. The first bolus will be given 30 minutes after intrathecal injection. In addition to the programmed boluses, patients will be able to administer patient-controlled epidural analgesia (PCEA) boluses of 5 mL every 10 minutes to a maximum of 15 mL (three PCEA boluses in a one hour period).
16075772|NCT02340793|Dietary Supplement|Counterweight Plus|A non-surgical, nutritionally replete weight management programme comprising a Total Diet Replacement Plan (TDR) of 800+ calories/day to produce a weight loss of >15kg over 12-20 weeks; followed by a structured Food Reintroduction phase for 6-8 weeks and a Weight Loss Maintenance phase; total intervention period 2 years.
16075773|NCT02340780|Drug|Buparlisib|
16075774|NCT02340767|Device|Spectra Device|Spectra Caries detection device is used for study data collection recording the results of the dental examination and recording results of dental treatment.
16075775|NCT02340767|Device|DIAGNOdent|DIAGNOdent Caries detection device is used for study data collection recording the results of the dental examination and recording results of dental treatment.
16075776|NCT02340754|Behavioral|Mindfulness-based Stress Reduction|
16075777|NCT02340754|Behavioral|MS Education Control|
16075778|NCT02340741|Procedure|conventional prophylaxis of aeroembolism|167 patients will be enrolled. Will perform standard way of aeroembolism prevention
16075779|NCT02340741|Procedure|conventional prophylaxis plus CO2 insufflation|167 patients will be enrolled. Will perform standard way of aeroembolism prevention and insufflation of carbon dioxide
16075780|NCT02340741|Procedure|cardiac surgery with opening of heart chambers|Patients with different clinical diagnoses, which is planned to cardiac surgery with the opening heart cavities
16075781|NCT02340728|Device|ERCP with SEMS plus radiofrequency ablation|
16075782|NCT02340728|Device|ERCP with SEMS alone (standard of care)|
16075783|NCT02340702|Other|COPD|COPD as diagnosed clinically or based on pulmonary function test showing post-bronchodilator forced expiratory volume in one second to forced vital capacity ratio of <0.7.
16075784|NCT02340689|Other|Genetic Analysis|We will draw one tube of blood from your arm to obtain white blood cells. These white blood cells will be used as a source of DNA for genetic analysis.
16075785|NCT02340676|Procedure|Extracorporeal Photopheresis (ECP)|Participants receive ECP treatment twice a week for 16 weeks
16075786|NCT02340676|Drug|Interleukin-2|Participants receive daily IL-2 injections starting Week 8 of study and ending at Week 16
16075787|NCT02340663|Device|SOVA Bite Splint|Over-the-counter thermoplastic bite splint blank, heated, molded to fit.
16075788|NCT02340663|Device|Michigan Bite Splint|Heat-cured acrylic bite splint fabricated by dentist/dental technician to fit
16075789|NCT02340650|Device|Standard High Resolution Microendoscope and/or Line-Scanning Confocal High Resolution Microendoscope|
16075790|NCT02340637|Behavioral|Coping Kids|The first half (10 sessions) of Coping Kids focuses on building skills that are common to both anxiety and depression. The children practice strategies to regulate their mood, learn problem-solving, and behavioral activation is used to break the cycle of withdrawal. The second half of Coping Kids (10 sessions) is focused on the youth's specific problem; for depressive symptoms, building a positive self-schema and behavioral activation; for anxiety problems, gradual exposure to fear-inducing situations. Cognitive restructuring directed at different maladaptive thoughts is also emphasized.
16075791|NCT02340637|Behavioral|TAU|Treatment as usual
16075792|NCT02340624|Behavioral|Referral to SmokeFreeMoms, Quitline or Brief intervention|"SmokeFreeMom is a mobile text messaging service designed for pregnant women across the United States to help them quit smoking. The program provides 24/7 encouragement, advice, and tips to help pregnant women and mothers quit smoking and stay quit.
~The 1-800 QuitLine provides smoking cessation services to Michigan residents who want to quit using tobacco. The Quit Line offers a personal health coach and participant toolkits to help tobacco users gain confidence and motivation they need to quit for good.
~Computer-delivered 5As (CD-5As) brief intervention The software platform to be used for this study features an interactive three-dimensional narrator, clear and relevant graphics, and aura;Participants use headphones for privacy while working with the computer."
16075793|NCT02340611|Drug|Olaparib|Polyadenosine 5'diphosphoribose polymerase (PARP) Inhibitor
16075794|NCT02340611|Drug|Cediranib|Vascular endothelial growth factor (VEGF) receptor tyrosine kinase inhibitor that is a potent inhibitor of all three VEGF receptors (VEGFR-1, -2 and -3)
16075796|NCT02340585|Device|Next Generation Neuroform Stent System|The Next Generation Neuroform Stent System is pre-loaded on a stent delivery wire and protected by a transfer sheath. An accessory pouch containing an optional stabilizer may be attached to the proximal end of the stent delivery wire to facilitate handling and stabilization.
16075797|NCT02340572|Drug|PRS-080#022-DP|hepcidin antagonist
16075798|NCT02340572|Drug|PRS-080-Placebo#001|Placebo treatment
16075799|NCT02340559|Behavioral|Meta-cognitive Training|
16075800|NCT02340559|Behavioral|Psychoeducational group|
16075801|NCT02340546|Device|cardiac resynchronization therapy|cardiac resynchronization by means of biventricular pacing via left ventricular pace from coronary sinus veins combined with conventional any-site right ventricular pace
16075802|NCT02340533|Procedure|hysteroscopic endo-myometrial biopsy|
16075803|NCT02340533|Device|ultrasound|two dimensional trans-vaginal ultrasonography
16075804|NCT02340520|Drug|Theophylline|Oral
16075805|NCT02340520|Drug|Roflumilast|Oral
16075806|NCT02340507|Other|Rice and bread (high GI)|Rice is a high glycaemic index glutinous rice. Bread is a high glycaemic index white bread.
16075807|NCT02340507|Other|Rice and bread (low GI)|Rice is a low glycaemic index parboiled basmati rice. Bread is a low glycaemic index multigrain bread.
16075808|NCT02340494|Behavioral|Online Enhanced Education Tool|The website resource will be credible, comprehensive, relevant and engaging information that young women with breast cancer will use intensively for self-management and education.
16075809|NCT02340481|Drug|Loperamide hydrochloride + simethicone chewable tablet|Each tablet contains 2 milligram (mg) of loperamide hydrochloride and 125 mg of simethicone.
16075810|NCT02340481|Drug|Loperamide hydrochloride|Each capsule contains 2 mg of loperamide hydrochloride
16075811|NCT02340481|Drug|Loperamide hydrochloride + simethicone chewable placebo tablet|Placebo matched to loperamide hydrochloride and simethicone chewable tablet.
16075812|NCT02340481|Drug|Loperamide hydrochloride placebo capsule|Placebo matched to loperamide hydrochloride capsule.
16075813|NCT02340468|Device|diffuse optical spectroscopy|diffuse optical spectroscopy
16075814|NCT02340455|Drug|Pregabalin_male|Pregabalin 150mg bid 1day Men
16075815|NCT02340455|Drug|Pregabalin_female|Pregabalin 150mg bid 1day Women
16075816|NCT02340455|Drug|Placebo_Men|Placebo durg
16075817|NCT02340455|Drug|Placebo_Women|Placebo_Women
16075818|NCT02340442|Other|Obstetrical care parameters|
16075819|NCT02340442|Other|DVA measurements|
16075820|NCT02340442|Other|Fundus photographs|
16075821|NCT02340429|Device|DE500 Digital Video Otoscope|
16075822|NCT02340416|Device|Transcranial Doppler Ultrasound, DWL Doppler BoxX|
16075823|NCT02340403|Procedure|NMR Spectroscopy|
16075824|NCT02340390|Device|G7|The Biomet G7™ Acetabular System has been designed to provide more options to surgeons for treatment of patients needing total hip arthroplasty, while concurrently simplifying the surgical process with well-designed, modular components and corresponding instruments. The G7™ Acetabular System includes three liner types; ArComXL highly-crosslinked or E-1 Vitamin E-infused polyethylnene and a Biolox Delta (Ceramtec, Plochingen, Germany) ceramic liner.
16075825|NCT02340390|Device|Exceed ABT|The Exceed ABT Acetabular System has been designed for cementless fixation and consists of an acetabular shell and an acetabular insert. The acetabular insert/bearing includes a tapered outer geometry that matches the inner geometry of the acetabular shell and an inner hemispherical geometry to suit the varying modular head diameters. Inserts/bearings are inserted into the acetabular shell intra-operatively and are available in varying sizes to match the acetabular shell diameters. The insert/bearings are available in Biolox Delta ceramic (CeramTec AG).
16075826|NCT02340377|Device|ELITE 3 HQ|The pill is about the size of a multivitamin, is coated with special medical plastic, and is easy to swallow. The pill sends radio signals to a small recording device that participants wear that send a signal to a monitor and records the participant's internal body temperature. The pill will exit the participant's body in one of his/her bowel movements approximately 1-5 days after ingestion. Pills are not reused.
16075827|NCT02340364|Behavioral|Education + Patient Navigation|208 patients randomized to self-care Education+ Patient Navigation-delivered self-care plan.
16075828|NCT02340364|Behavioral|Self-care Education|208 patients randomized to self-care education alone.
16075829|NCT02340351|Device|Auricular acupuncture|Auricular acupuncture according to the the NADA protocol includes the needling of five specific acupuncture points on both ears: point 51 (= Sympathetic point), point 55 (= Shen Men), point 95 (= Kidney point), point 97 (= Liver point) and point 101 (= Lung point). All points were acupunctured with fine sterile single use steel needles with the size of 0.25 x 20 millimetres. The needles were inserted about 2-3 millimetres, so that the needle point pierces the skin and is just positioned in the cartilage of the ear. They remained in position for 30 minutes.
16075830|NCT02340351|Procedure|Progressive muscle relaxation|Progressive muscle relaxation was carried out by the method of Bernstein and Borkovec. All participants were asked to close eyes while sitting comfortably. Each group session included 16 main exercises of consciously tensing and relaxing specific groups of muscles.
16075831|NCT02340338|Biological|rTSST-1 Variant Candidate Vaccine|"In the absence of adverse events classified as clinically relevant, interval between dose escalations 1 week. Immunization to be repeated at the same dose level 1 - 2 months later. If immunogenicity can be shown after the second administration of 1 µg, the sample size will be increased from 3 + 1 to 9 + 3. Otherwise, the sample size of 3 + 1 will continue until immunogenicity is seen at a higher dose level. If there is no immune response in any dose group after the second immunization, a third injection will be given 4 -8 weeks thereafter in dose groups of 1 µg and above.
~Immunogenicity is defined by seroconversion from a TSST-1 Ab titer of < 20 to > 40 or a 4-fold increase in TSST-1 Ab titer .
~Patients 3 µg or more will be randomized."
16075875|NCT02340039|Dietary Supplement|Polyphenols|Drinks will be delivered in random order at 3 separate study visits immediately before a high-carbohydrate meal. Seven days wash-out period will be required between study days.
16075910|NCT02339753|Drug|Carboplatin|Blood sampling will be done at the time before administration (0hr pre-dose), 1hr, 2hr, 5hr for pharmacokinetic study.
16075911|NCT02339740|Drug|Arsenic Trioxide|Given IV
16075912|NCT02339740|Drug|Cytarabine|Given IV
16075913|NCT02339740|Drug|Dexamethasone|Given PO or IV
16075914|NCT02339740|Drug|Idarubicin|Given IV
16075832|NCT02340325|Drug|Acute Application of kynurenic acid cream|Pouches containing 0.00% (placebo), 0.15%, 0.25%, 0.4% and 0.5% of FS2 will be randomly applied to an occlusive, transparent dressing (Tegaderm) and applied to each test area. The pouch order will be random, generated by the www.random.org list generator each application. The study team member applying the cream will randomly choose the application sites of different concentrations of the FS2 creams and mark the corresponding cream code name on a separate sheet. This study member will not be evaluating the results and the evaluating study member will be blinded to the randomization. Patients will be evaluated at 24 hours post application for skin reactions and adverse reactions by a blinded observer recorded. Before and after photographs will be taken.
16075833|NCT02340325|Drug|Chronic application of kynurenic acid cream|Volunteers will be educated how to apply a pouch of cream to an occlusive, transparent dressing (Tegaderm) and place it on the test site every 24 hours for 30 days. The date and time of first application will be recorded. Baseline urine and serum measurements of drug concentration (presumed absent), as well as complete blood count, liver enzymes, blood urea nitrogen, and creatinine will be taken on Day 0 (the initial enrollment of each part). The volunteers will be seen in follow-up at day 1, day 5, day 15, and day 30
16075834|NCT02340312|Procedure|EGD|In this study patients are being scoped(EGD) as standard of care and being asked to allow .5 aggregate of tissue biopsy to be taken for research purposes.
16075835|NCT02340312|Other|Collection of Stool Specimens|We will be collecting stool samples from each participant for research purposes. Within two weeks after EGD tissue collection.
16075836|NCT02340299|Device|nHFOV|Extubation to ventilator-derived nHFOV using binasal prongs
16075837|NCT02340299|Device|nCPAP|Extubation to ventilator-derived nCPAP using binasal prongs
16075838|NCT02340273|Device|Therapeutic ultrasound|Patients receive therapeutic ultrasound daily for 4 hours of continuous therapy at 3 megahertz (MHz) frequency and 0.132 Watts/cm2.
16075839|NCT02340273|Device|Placebo therapeutic ultrasound|"Patients receive sham therapeutic ultrasound daily for 4 hours."
16075840|NCT02340260|Behavioral|High intensity interval training|High intensity exercise during 12 weeks with three weekly training sessions
16075841|NCT02340260|Behavioral|Sprint interval training|Sprint interval exercise during 12 weeks with three weekly training sessions
16075842|NCT02340247|Other|Water|
16075843|NCT02340247|Drug|Ursodeoxycholic Acid|
16075844|NCT02340247|Drug|Chenodeoxycholic Acid|
16075845|NCT02340234|Drug|Lebrikizumab|Lebrikizumab will be administered SC as per the schedule specified in the respective arms.
16075846|NCT02340234|Drug|Placebo|Placebo matching to lebrikizumab will be administered as per the schedule specified in the respective arms.
16075847|NCT02340234|Drug|TCS Cream|TCS cream (triamcenolone acetonide 0.1% or hydrocortisone 2.5% cream) twice daily
16075848|NCT02340221|Drug|Taselisib|Taselisib 4 mg was administered as two tablets of 2 mg each as per the schedule specified in the respective arm.
16075849|NCT02340221|Drug|Placebo|Placebo matching to taselisib was administered as per the schedule specified in the respective arm.
16075850|NCT02340221|Drug|Fulvestrant|Fulvestrant 500 mg was administered as two IM injections of 250 mg each as per the schedule specified in the respective arms.
16075851|NCT02340208|Drug|L-DOS47|A treatment cycle will be 21 days with patients receiving L-DOS47 on cycle Days 1 and 8.
16075852|NCT02340195|Drug|Idalopirdine (Lu AE58054) 60 mg|encapsulated film-coated tablets for oral use once daily for 10 days
16075853|NCT02340182|Drug|Vancomycin|250mg 3dd2
16075854|NCT02340182|Drug|Ciprofloxacin|500mg 2dd1
16075855|NCT02340182|Drug|Metronidazole|500mg 3dd1
16075856|NCT02340169|Drug|Topicort® (desoximetasone) Topical Spray, 0.25%|Topicort® (desoximetasone) Topical Spray, 0.25% applied to affected areas twice a day for 28 days
16075857|NCT02340156|Genetic|SGT-53|SGT-53, at 3.6 mg DNA per infusion, will be administered twice per week for 3 weeks (on Day 1, 4, 8, 11, 15 and 18 of each cycle) for 3 cycles. If SGT-53-related toxicity occurs, the dose of SGT-53 will be de-escalated to 2.4 or 1.2 mg DNA/infusion when appropriate.
16075858|NCT02340156|Drug|Temozolomide|TMZ will be administered orally on days 9-13 of each cycle. In cycle 1, the dose of TMZ will be 150 mg/m². If the TMZ-related toxicities are tolerated in cycle 1, the dose of TMZ will be escalated to 200 mg/m² for cycle 2 and beyond. If TMZ-related toxicity occurs, the dose if TMZ will be de-escalated to 125 mg/m² (dose level -1), 100 mg/m² (dose level -2) or 75 mg/m² (dose level -3) when appropriate.
16075859|NCT02340143|Other|Control|Marketed partially hydrolyzed cow's milk protein infant formula
16075860|NCT02340143|Other|Investigational|Partially hydrolyzed cow's milk protein infant formula with a probiotic
16075861|NCT02340130|Biological|DP/MG/14-1|The administration regimen will consist of a rush build-up régimen and a follow up period
16075862|NCT02340130|Biological|DP/MG/14-2|The administration regimen will consist of a rush build-up régimen and a follow up period
16075863|NCT02340117|Genetic|SGT-53|The dose of SGT-53 will be 3.6 mg DNA/infusion. If necessary, the dose of SGT-53 can be de-escalated to 2.4 mg, 1.2 mg or 0.6 mg DNA per infusion in the event that increased toxicity probably or definitely related to SGT-53 is observed with the combination.
16075864|NCT02340117|Drug|nab-paclitaxel|The dose of nab-paclitaxel will be 125 mg/m² and will be administered once weekly (day 3) in weeks 1, 2, 3, 5, 6 and 7. If increased toxicities related to administration of nab-paclitaxel is observed, the dose of nab-paclitaxel can be reduced to 100 or 75 mg/m² when appropriate.
16075865|NCT02340117|Drug|Gemcitabine|The dose of gemcitabine will be 1000 mg/m² and will be administered once weekly (day 3) in weeks 1, 2, 3, 5, 6 and 7, after the administration of nab-paclitaxel. If increased toxicities related to administration of gemcitabine is observed, the dose of gemcitabine can be reduced to 800 or 600 mg/m² when appropriate.
16075866|NCT02340104|Drug|Baricitinib|4 milligrams (mg) administered orally
16075867|NCT02340104|Drug|[^13C4D3^15N]-baricitinib|4 micrograms (μg) administered intravenously (IV)
16075868|NCT02340091|Device|HA IDF plus|
16075869|NCT02340091|Device|HA IDF|
16075870|NCT02340078|Device|HA IDF II plus|
16075871|NCT02340078|Device|HA IDF II|
16075872|NCT02340065|Procedure|standard colonoscopy|examination of the colon with a conventional colonoscope
16075873|NCT02340065|Procedure|Endocuff-assisted colonoscopy|examination of the colon with Endocuff-assisted colonoscopy
16075915|NCT02339740|Other|Laboratory Biomarker Analysis|Correlative studies
16075876|NCT02340026|Other|Dynamic Supported Mobility|Dynamic weight support; Child-directed; No assistive devices, limited use of orthoses, no treadmill; Encourage high degree of error with reduced physical assistance; Encourage frequent variability in motor tasks (no redirection when moving from one activity to another); Physical therapist expertise is focused on designing a salient and challenging environment for the child's specific interests and ability level to encourage engagement, variability, challenge, and error experience, and on determining the appropriate amount of weight assistance
16075877|NCT02340026|Other|Conventional Therapy|"No or static weight support; Therapist-directed (therapist initiates); Traditional early gait training methods: use of assistive devices/orthoses and may use treadmill; Focus on producing typical movement patterns with extensive manual guidance/correction from therapist, prevention of falls; Therapy activities grouped into blocks of practice (i.e. repeated floor to stand practice followed by gait training); Physical therapist expertise is focused on designing and directing the specific practice activities each session, tailored to the individual child"
16075878|NCT02340013|Drug|Medroxyprogesterone acetate|Women in this arm of the study will be assigned to start medroxyprogesterone acetate 10mg per os x 10 days. This will be followed by vaginal bleeding. On the 3rd day of vaginal bleeding, women will start clomiphene citrate 50mg per os x 5 days for ovulation induction.
16075879|NCT02340000|Drug|standard dose amoxicillin/clavulanate|amoxicillin/clavulanate 875/125 + placebo bid x 7 days
16075880|NCT02340000|Drug|high dose amoxicillin/clavulanate|Time Period I: extended-release amoxicillin/clavulanate 1000/62.5 two tablets bid x 7 days Time Period 2: immediate-release amoxicillin/clavulanate 875/125 plus amoxicllin 875 bid x 7 days
16075881|NCT02339974|Device|Heterotopic Implantation Of the Edwards-Sapien XT Transcatheter Valve in the Inferior VEna Cava|
16075882|NCT02339961|Radiation|Ultrasound radiation|Recording Doppler ultrasound noninvasively from the right chest wall
16075883|NCT02339948|Radiation|SBRT|8.0 Gy per fraction for 5 fractions for a total of 40 Gy
16075884|NCT02339935|Behavioral|Brief Analogue Functional Analysis|The Brief AFA seeks to identify the function of the challenging behavior by creating controlled test conditions in which specific responses are provided for challenging behavior (e.g., attention, escape from task demands, access to tangible - including variants of each as needed), as well as a control condition in which continual access to attention and preferred items is provided. It consists of a 30-90-minute abbreviated analysis comprised of a single exposure to 2-5-minute test and control conditions, along with replication of applicable test conditions and a treatment probe, which provides evidence of challenging behavior function faster than other methods.
16075885|NCT02339935|Other|No Brief AFA|These participants will receive typical standard of care procedures while hospitalized, but will not receive the additional behavioral intervention
16075889|NCT02339909|Behavioral|Fixed financial incentive|"Participants receiving the fixed financial incentive intervention will be sent a screening appointment letter offering them a fixed amount of £10 if they attend their screening appointment."
16075890|NCT02339909|Behavioral|Probabilistic financial incentive|"Participants receiving the probabilistic financial incentive intervention will be sent a screening appointment letter offering them an entry into a lottery with at least a 1 in 100 chance of winning £1000 if they attend their screening appointment."
16075891|NCT02339909|Behavioral|Control|"Participants receiving the active comparator, (i.e. control) intervention, will be sent the standard diabetic retinopathy screening appointment letter."
16075892|NCT02339896|Biological|rabies vaccine|rabies vaccine 0.1 ml intradermal two site for 4 times
16075893|NCT02339870|Other|Psychosocial Support for Caregiver|Complete expressive disclosure writing
16075894|NCT02339870|Other|Psychosocial Support for Caregiver|Complete benefit finding writing
16075895|NCT02339870|Other|Questionnaire Administration|Ancillary studies
16075896|NCT02339870|Other|Sham Intervention|Complete writing on an emotionally neutral topic
16075897|NCT02339857|Procedure|No-touch harvesting technique|The saphenous vein is harvested with a pedicle of surrounding tissue.
16075898|NCT02339844|Drug|Aripiprazole|6 weeks of individual doses of aripiprazole
16075899|NCT02339831|Device|CAMOPED|Camoped given after surgery
16075900|NCT02339831|Device|CPM passive motion device|passive motion device given after surgery
16075901|NCT02339805|Other|next generation sequencing|DNA from plasma, peripheral blood mononuclear cell and bone marrow will be sequenced by NGS for a panel of 34 genes.
16075902|NCT02339805|Device|Fluorine-18 fluorodeoxyglucose positron emission tomography (18F-FDG-PET)|tumor Assessment tool during the study
16075903|NCT02339792|Other|E-learning|e-learning program of medical education, focused on teaching and implementing Comprehensive Geriatric Assessment (CGA) added to geriatric pharmacological notions (GPNs)
16075904|NCT02339779|Procedure|autologous fat transfer|"Each procedure consists of the transfer of syringe-aspirated fat (form the abdomen, thighs, flanks) to the breast by injection in the subcutaneous planes.
~Typically three separate procedures are needed for a complete breast reconstruction:
~First session comprises of sub- and intrapectoral fat transfer during the primary mastectomy surgery, providing volume to the deep tissue planes.
~Second session is preceeded by wearing an external pre-expansion device to prepare the recipient site for grafting. It aims to give the breast its shape and initial volume.
~Third session is also preceded by external pre-expansion and aims to provide extra volume of the breast to achieve symmetry with the healthy breast."
16075905|NCT02339779|Procedure|breast implant|"Implant-based reconstruction typically will occur as follows:
~During the primary mastectomy surgery, a tissue expander will be implanted subpectorally.
~The tissue expander will be gradually filled with sterile saline during outpatient clinic visits.
~When the desired volume is achieved, a second operation will be planned, to exchange the tissue expanded with the definite breast implant.
~(Note: in patients who are receiving encapsulectomy and implant exchange, the first 2 steps are skipped.)"
16075916|NCT02339740|Drug|Mitoxantrone Hydrochloride|Given IV
16075920|NCT02339727|Dietary Supplement|Preterm infants formula|The group 1 of children will receive a preterm infants formula supplemented with DHA and ARA with a relationship omega 6/omega 3 = 2/1 during the first 3 months of life. And group 2 will receive other Preterm infants formula very similar, but with a ratio of DHA and AA=1/1 also during the first 3 months of life.
16075921|NCT02339714|Other|acupuncture combined moxibustion|"Points: Hegu(LI4),Yingxiang(LI20),Chize(LU5),Sibai(ST2), Yintang(EX-HN3),Shangyingxiang(EX-HN8),Shangxing(GV23),Dazhui(Du14).
~Pierced the skin, needles are inserted 0.5 to 2cm into the acupoints. Each needle are roated until the participants and the practitioner felt de-qi sensation. After that, moxibustion is applied to Dazhui(Du14). A 1cm long moxa cone is putted on the top of the needle at the acupoint, then ignite moxa cone until the cone is burn. The needles are left in place for 30 minutes. once every two days, 3 times in a week for consecutive 4 weeks, 12 times altogether."
16075922|NCT02339714|Drug|Loratadine|Loratadine will be taken orally at the dose of 10mg/day in the morning. Each treatment cycle will be given for continuous 4 weeks.
16075923|NCT02339701|Radiation|IMRT|
16075924|NCT02339701|Radiation|SBRT|
16075925|NCT02339688|Other|conventional MS rehabilitation|assessment pre and post conventional MS rehabilitation
16075926|NCT02339675|Other|conventional MS rehabilitation|assessment pre and post conventional MS rehabilitation
16075927|NCT02339662|Drug|Gabapentin|muscles pain treatment
16075928|NCT02339662|Drug|Amitriptyline|muscles pain treatment
16075929|NCT02339649|Procedure|Blood Sample|Blood Sample
16075930|NCT02339649|Behavioral|Neurocognitive Assessment|Neurocognitive Assessment
16075931|NCT02339649|Other|Resting State EEG|10-20 Minutes of Resting State EEG
16075932|NCT02339649|Procedure|Lumbar Puncture|Lumbar Puncture
16075933|NCT02339649|Other|MRI|60 Minutes MRI
16075934|NCT02339636|Other|PDUS examination|
16075935|NCT02339623|Device|Ultrasound imaging|"- Fetal adrenal gland volume calculation using 3D ultrasound
~- Assessment of the fetal central adrenal zone enlargement by 3D ultrasound
~- CL measurement using 2D ultrasound"
16075936|NCT02339610|Device|ATTUNE Primary, Cemented Total Knee Replacement|Patients will undergo a primary total knee replacement using one of the four implant configurations of the ATTUNE knee ( CR FB, CR RP, PS FB, PS RP).
16075937|NCT02339597|Procedure|Automatic Positive Airway Pressure (APAP) initiation|
16075938|NCT02339584|Drug|Brinzolamide 10 mg/mL / Brimonidine 2 mg/mL fixed combination eye drops, suspension|
16075939|NCT02339584|Drug|Brinzolamide 10 mg/mL eye drops, suspension|
16075940|NCT02339584|Drug|Brimonidine 2 mg/mL eye drops, solution|
16075941|NCT02339584|Drug|Vehicle|Inactive ingredients used as a placebo for masking purposes
16075945|NCT02339558|Other|Laboratory Biomarker Analysis|Correlative studies
16075946|NCT02339558|Biological|Nivolumab|Given IV
16075947|NCT02339545|Device|Coronary Orbital Atherectomy plus Stenting|
16075948|NCT02339532|Drug|FEC100|"3 cycles of FEC 100 administered IV q3w
~5-Fluorouracil (5-FU) 500 mg/m²
~Epirubicin 100 mg/m²
~Cyclophosphamide 500 mg/m²"
16075949|NCT02339532|Drug|Docetaxel|TOP2A amplified : DOCETAXEL 75 mg/m² IV escalating at 100 mg/m² IV as tolerated q3w TOP2A not amplified : DOCETAXEL 75 mg/m² IV
16075950|NCT02339532|Drug|Trastuzumab|Trastuzumab 8 mg/kg loading dose administered intravenously (IV) followed by 6 mg/kg IV q3w in subsequent cycles.
16075951|NCT02339532|Drug|Pertuzumab|Pertuzumab 840 mg loading dose administered IV followed by 420 mg IV q3w in subsequent cycles.
16075952|NCT02339532|Drug|Carboplatin|CARBOPLATIN AUC 6 IV q3w
16075953|NCT02339519|Device|LMA CLASSIC|Classic LMA consists of a mask with a surrounding inflatable bag compatible to the shape of the hypopharynx and a tube that has a 30° angle with a mask.
16075954|NCT02339519|Device|LMA FASTRACH|Fastrach LMA has similar features to the LMA Classic, but it is designed to provide upper airway during intubation via blind intubation or fiberoptic assistance. It has a rigid handle that allows one-handed insertion, removal or adjustment.
16075955|NCT02339519|Device|LMA SUPREME|Supreme LMA is a novel, sterile, single use, new generation supraglottic airway device which provides more rapid and higher volume gas passage through airway and can be inserted in a rapid and safe manner.
16075956|NCT02339506|Drug|Cosyntropin|Subjects will receive cosyntropin at 70 mcg/hr for two sessions of 2.5 hours each on day 2 of a three day admission to our research center.
16075957|NCT02339506|Drug|Placebo|Subjects will receive placebo (normal saline infusion) for two sessions of 2.5 hours each on day 2 of a three day admission to our research center.
16075958|NCT02339493|Other|Computer Electronic Alert|A computer program that will issue an on-screen electronic alert notifying the responsible provider that his or her patient is high-risk for stroke due to AF or atrial flutter and that the patient is not ordered to receive anticoagulant therapy. The alert will provide options for anticoagulation for stroke prevention in AF as well as additional information in the form of suggested reading.
16075959|NCT02339480|Other|Massage therapy|Healthy volunteers do not accept treatment, just to be a control group to compare with obesity group
16075960|NCT02339467|Other|GO-OUT program|Participants attend the walking workshop followed by a 3-month outdoor walking group intervention, twice weekly for 60-minutes. Each session includes a 10-minute warm-up and cool down, and a planned walk in an outdoor community environment. Continuous walking exercise will gradually increase from 10 to 60 minutes, as well increase difficulty. Balance exercises will be included in the warmup and walk. There will be a variety of surfaces and environmental factors to challenge the participants, e.g., carrying objects, diverting the walker's attention, crossing at a light, walking up and down curbs, slopes, and level or uneven surfaces. Supervision will be on a 1:3 facilitator-to-participant ratio to allow for assistance and individualization of the intervention where necessary.
16075995|NCT02339220|Behavioral|enhanced Transfer Package (eTP)|This intervention will take, on average, 30 minutes out of the 3.5 hour daily planned for treatment. It is an enhanced form of the sTP. The enhancements include a computerized version of the daily diary, cues to be placed in patients' homes to prompt engagement in desired activities, and additional follow-up phone calls.
16075996|NCT02339207|Drug|AL-335 matching placebo|
16075997|NCT02339207|Drug|AL-335|
16075961|NCT02339467|Other|Task-oriented outdoor walking workshop|The 1-day workshop will be 5 hours with breaks. Participants will complete a series of stations learning information, strategies and skills related to safely walking outdoors. Stations include: pedometer use; walking pole use; footwear; footcare; fall prevention; balance exercises; proper use of walking aids; correct posture; self-management of exercise intensity; goal setting; and walking safely outdoors. Participants will receive a workbook with Canadian Physical Activity Guidelines, benefits of outdoor walking, information for each workshop station and a pedometer. Participants will use the workbook as an information resource and to record their community ambulation goals, planning routes, and walking time. All participants will be encouraged to walk outside with a partner, for safety.
16075962|NCT02339454|Device|Active treatment group|Energy Density - 0.09 mJ/mm2 Device: Active Applicator
16075963|NCT02339454|Device|Placebo group|Placebo Applicator
16075964|NCT02339441|Drug|Methotrexate|Immunosuppressant agent. Patients treated with Methotrexate at the entry of the study, either oral or subcutaneous with a target dose of 20-25mg weekly.
16075965|NCT02339441|Drug|Mycophenolate mofetil|Immunosuppressant agent. Patients treated with Methotrexate at the entry of the study,recommended dose 500 mg twice daily for 2 weeks increasing to 1gm twice daily.
16075966|NCT02339441|Drug|Cyclophosphamide|Immunosuppressant agent. Patients treated with Methotrexate at the entry of the study, recommend use (i) IV. Minimum monthly dose 500mg/m2 with a recommended duration of 6-12 months. (ii) Oral. 1-2mg/day with a recommended duration of 12 months.
16075967|NCT02339428|Drug|diclophenac sodium|Patients will be given 100mg p.o. diclophenac sodium tablets
16075968|NCT02339428|Drug|Placebo|Inactive pill manufactured to mimic diclofenac tablet
16075969|NCT02339415|Drug|Edoxaban 30mg daily|
16075970|NCT02339415|Drug|Matching placebo|
16075971|NCT02339389|Other|Labor analgesia|Measuring maternal ventilation after placement of epidural analgesia compared to baseline
16075972|NCT02339376|Device|Low-frequency repetitive transcranial magnetic stimulation|
16075973|NCT02339376|Device|High-frequency repetitive transcranial magnetic stimulation|
16075974|NCT02339376|Device|Sham repetitive transcranial magnetic stimulation|
16075975|NCT02339363|Behavioral|Sitting Meditation|4 weeks Sitting Meditation
16075976|NCT02339363|Behavioral|Hatha yoga|4 weeks of Hatha yoga
16075977|NCT02339350|Drug|high dose methotrexate|HD-MTX IV 5,000 mg/m2 I.V. over 4hr on day 0, 14, 28, 42 of SER interim maintenance schedule
16075978|NCT02339350|Drug|Intrathecal triple chemotherapy|Intrathecal triple chemotherapy for SEG group instead of radiotherapy
16075979|NCT02339337|Other|Abbreviation of treatment duration|
16075980|NCT02339324|Drug|Pembrolizumab and high dose interferon alfa-2b (HDI)|Pembrolizumab and HDI will be given concurrently during the induction phase of the study for up to 6 weeks from treatment initiation. This is followed by surgery. After recovery from surgery, pembrolizumab and HDI will be reinitiated as maintenance therapy during the maintenance phase of the study.
16075981|NCT02339311|Other|Educational intervention of Lifestyle and patient activation in diabetics|Participants underwent a one hour group didactic session led by Community Health Representatives (CHRs) who subsequently carried out monthly home-based educational interventions to encourage healthy lifestyles, including diet, exercise, and alcohol and cigarette avoidance until follow up at 6 months, when clinical phenotyping and the PAM survey were repeated.
16075982|NCT02339298|Other|music application|music is applied during anaesthesia using headphones
16075983|NCT02339298|Other|only headphones|music is not applied, only headphones are placed
16075984|NCT02339298|Drug|a caudal block|
16075985|NCT02339285|Device|tACS (alpha)|
16075986|NCT02339285|Device|tACS (gamma)|
16075987|NCT02339272|Other|non interventional|
16075988|NCT02339259|Other|Observation|
16075989|NCT02339246|Drug|Prograf vs Envarsus XR vs Astagraf XL|prograf vs Envarsus XR vs Astagraf XL
16075990|NCT02339246|Drug|Prograf vs Astagraf XL vs Envarsus XR|Prograf vs Astagraf XL vs Envarsus XR
16075991|NCT02339233|Device|Standing and Stepping with spinal cord Epidural Stimulation|Standing and Stepping with support from trainers as needed, overground or in a harness with body weight support on a treadmill. Epidural stimulation with specific configurations will be administered to generate standing and stepping.
16075992|NCT02339220|Behavioral|Constraint-Induced Movement Therapy (CIMT)|Constraint-Induced Movement Therapy (CIMT) is a form of physical rehabilitation based on basic research in behavioral psychology and behavioral neuroscience. The therapy will be given on an outpatient basis for 3.5 hours/day for 10 consecutive weekdays. This treatment has four components: 1. intensive training in use of the more-affected arm; 2. organization of this training following shaping principles, which involve frequent positive feedback and progressively increasing the demand of the task in small increments; 3. discouraging use of the less-affected arm by placing the hand in a padded safety mitt, and 4. a set of behavioral procedures, known as the Transfer Package, for transferring gains from the treatment to real-world setting. In this study, two forms of the Transfer Package, standard and enhanced, will be used and form a separate factor (see below).
16075993|NCT02339220|Behavioral|Lakeshore Enriched Fitness Training (LEFT)|This treatment will given on an outpatient basis for 3.5 hours per day for 10 consecutive weekdays. It will consist of the following components: general fitness exercises (largely lower extremity), sports and recreation (land and water-based); adapted Yoga; breathing exercises and postural control, movement to music, massage therapy, meditation and Progressive Muscle Relaxation (PMR).
16075994|NCT02339220|Behavioral|standard Transfer Package (sTP)|This intervention will take, on average, 30 minutes out of the 3.5 hour daily planned for treatment. The sTP is a set of behavioral procedures for transferring gains from the treatment setting to real-world. The procedures when the sTP is applied to CIMT include negotiating a behavioral contract with the patient and caregiver, when available, about use of each arm during the treatment period, keeping a daily diary on arm use, completing a structured interview about use of the more-affected arm in daily, problem solving about perceived barriers to use of the more-affected arm outside the treatment setting during treatment, and four weekly follow-up phone calls to assess use of the more-affected arm and problem solve about any remaining barriers perceived to its use. The sTP when applied to the LEFT intervention will have parallel components that target engagement in fitness activities and overcoming perceived barriers to fitness in the home.
16076873|NCT02332824|Drug|TAK-272|TAK-272 tablets
16075998|NCT02339194|Procedure|Denture fabrication technique|"Both arm groups are composed by patients present severely resorbed mandibular alveolar bones who will receive complete dentures fabricated by means of a simpler techinique previously proved to be effective. Although for the traditional protocol group a second more complex impression step will be performed in order to evaluate if the simpler approach for this anatomical condition could be safely applied."
16075999|NCT02339168|Drug|Enzalutamide|Given PO
16076000|NCT02339168|Drug|Metformin Hydrochloride|Given PO
16076001|NCT02339155|Biological|AVA|Sterile, milky-white suspension with dosage level of 0.5 mL for SC administration
16076002|NCT02339155|Biological|Raxibacumab|Sterile, liquid formulation with unit dose strength of 40 mg/ kg for IV administration
16076003|NCT02339155|Drug|Diphenhydramine|Depending upon the labelling of the specific product chosen, 25 - 50 mg will be administered orally or IV
16076004|NCT02339142|Radiation|External beam radiotherapy|100 Rads to each lateral orbit x 10 doses
16076005|NCT02339142|Drug|intravenous corticosteroids (methylprednisolone)|Intravenous methylprednisolone (iv MP) 500 mg weekly x 6 weeks, then iv MP 250 mg x 6 weeks
16076006|NCT02339129|Drug|SST-0225|SST-0225 is a cream formulation for topical application. Each 5.4 g dose is formulated to topically deliver 400 mg of ibuprofen. The cream contains sodium ibuprofen and various salts.
16076007|NCT02339129|Drug|Placebo|Placebo IP will be the same vehicle as SST-0225 vehicle without the active ingredient, ibuprofen. It will be matched in appearance, smell, consistency, and color to SST-0225 topical ibuprofen cream.
16076008|NCT02339116|Drug|fluoruracil|
16076009|NCT02339116|Drug|Oxaliplatin|
16076010|NCT02339116|Drug|Irinotecan|
16076011|NCT02339116|Drug|Bevacizumab|
16076012|NCT02339103|Other|Warmed IV fluids|1 Liter of warmed IV fluids at 42 degrees celsius
16076013|NCT02339103|Other|Warmed perfusion pads|Neoprene perfusion pads placed on the palms and soles to rewarm through focusing on the arteriovenous anastomoses
16076014|NCT02339090|Drug|somavaratan|long acting growth hormone therapy
16076015|NCT02339090|Drug|Daily rhGH|daily growth hormone therapy
16076016|NCT02339064|Drug|apomorphine infusion|Treatment with apomorphine provided by continuous subcutaneous infusion using a portable external electronic pump device
16076017|NCT02339051|Behavioral|Jumping on one leg|
16076018|NCT02339038|Drug|Ledipasvir 90 mg and Sofosbuvir 400 mg|Ledipasvir 90 mg and Sofosbuvir 400 mg fixed dose combination as per standard of care treatment guidelines
16076019|NCT02338999|Radiation|PET/CT|The combined PET/CT scans provide images that pinpoint the anatomic location of abnormal metabolic activity within the body.
16076020|NCT02338999|Drug|Pioglitazone|Increases insulin sensitivity in muscle and adipose tissue, and inhibits hepatic gluconeogenesis.
16076021|NCT02338999|Drug|Placebo|
16076022|NCT02338973|Drug|Interferon gamma-1b|
16076023|NCT02338960|Drug|Bremelanotide|A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)
16076024|NCT02338960|Drug|Placebo|Placebo
16076025|NCT02338947|Procedure|Off-pump coronary-artery bypass grafting|Surgical access to the heart will be gained through a median sternotomy in all of the patients. In order to reduce the risk of bleeding and transfusions, an absorbable hemostat will be used in the sternal bone marrow. An automatic autotransfusion system will be used to recovery of red blood cells in all patients. Off-pump surgery will be performed with the use of heart stabilizers. Patients will be heparinized with 250 IU/kg intravenously to achieve activated clotting time >200s. The proximal anastomosis will be performed according to our guidelines. The distal anastomosis will be constructed with the help of mechanical stabilizers and cardiac positioner. Intracoronary shunts will be used routinely.
16076026|NCT02338947|Procedure|On-pump coronary-artery bypass grafting|Surgical access to the heart will be gained through a median sternotomy in all of the patients. On-pump surgery will be performed in normothermia, with the use of aortic cross-clamping and cold cardioplegic arrest. Patients will be heparinized with 500 IU/kg to achieve an activated clotting time >480 s. Heparin will be neutralized with 1:1 protamine sulfate. The automatic autotransfusion system will be used just in massive blood loss to recovery the red blood cells. Surgical techniques will be performed according to our guidelines.
16076027|NCT02338934|Drug|Combination Cinacalcet with Vitamin D analogue|Depending on the iPTH level and the serum calcium level they will be started on Cinacalcet 25mg OD and active Vitamin D will be adjusted. If Serum Cal <2.4 mmol/L - Start Cinacalcet 25mg OD & Increase active Vit D by 1 mcg/dose 3x/week Increase active Vit D by 1 mcg/dose 3x/week or Serum Ca 2.4-2.54 mmol/L- Start Cinacalcet 25mg OD and Maintain active Vit D dose OR if >2.54 mmol/L - Start Cinacalcet 25mg OD & Maintain active Vit D dose. Then they will go to maintenance phase.
16076028|NCT02338921|Drug|Sitagliptin|"100mg qd per oral during 24months
~compared with other treatment groups"
16076029|NCT02338921|Drug|Dapagliflozin|"10mg qd per oral during 24months
~compared with other treatment groups"
16076030|NCT02338921|Drug|Lobeglitazone|"0.5mg qd per oral during 24months
~compared with other treatment groups"
16076031|NCT02338921|Drug|Glimepirde|
16076032|NCT02338921|Drug|Metformin|
16076033|NCT02338908|Other|exercise program|Patients will be asked to perform an eccentric loading exercise program for the shoulder musculature, particularly the supraspinatus and infraspinatus muscles, to be performed on an individual basis twice every day. The therapeutic protocol will be applied for 5 weeks.
16076034|NCT02338908|Other|TrP-DN|In addition, within the second and fourth sessions, they will receive TrP-DN over active TrPs in the shoulder muscles
16076035|NCT02338895|Device|Ultrasound|Ultrasound of inferior vena cava and kidneys
16076036|NCT02338882|Device|Bi flex M multifocal intraocular lens|Multifocal intraocular lens
16076037|NCT02338882|Device|Bi flex 1.8 monofocal intraocular lens|Standard monofocal intraocular lens
16076038|NCT02338869|Behavioral|Dialogue-based psychosocial rehabilitation|
16076039|NCT02338856|Drug|MB12066 200mg|100mg bid (multiple dose, day 8)
16076040|NCT02338856|Drug|Placebo|100mg bid (multiple dose, day 8)
16076041|NCT02338843|Drug|LJPC-501|Treatment arm
16076042|NCT02338843|Drug|Placebo|PBO
16076043|NCT02338830|Drug|Progesterone|Women received vaginal progesterone suppositories (Cyclogest®, Actavis, Barnstaple, EX32 8NS, United Kingdom) in a dose of 400 mg daily beginning at 20-24 weeks gestational age
16076044|NCT02338817|Device|Diabetes Sentry|The Diabetes Sentry device will be monitored for alarms for possible hypoglycemic. A blood sample will be taken to confirm blood glucose levels, lactate, and ketone values.
16076045|NCT02338804|Biological|MV|MV is an intravenous intralipid suspension with 5 various vaccines, including DPT (diphtheria, pertussis, and tetanus ), typhoid, Staphylococcus aureus, paratyphoid A and B. Accessories include microbial A, lecithin, Twain-80, span 20 and soy-bean oil for injection. Inject 0.5 ml of the mixture subcutaneously every week. Best reaction after injection was defined as showing regional red and swollen at the injection point and mild fever and to achieve this, dose increasing or reduction is acceptable.
16076046|NCT02338804|Other|standard treatment|Patient will receive a comprehensive histological and imaging check up to evaluate the histological type, stage of the disease and performance status. Then the patient will receive standard treatment, in brief, surgical resection for early stage patients and systemic treatment including chemotherapy for advanced stage patients, according to NCCN guide line.
16076047|NCT02338791|Device|Manual Mobilization|Stabilization of the glenoid fossa with movement of the humerus using varying degrees of force as applied by a physical therapist. Subject is positioned with the shoulder in 55 degrees of abduction and 30 degrees of horizontal adduction. Manual force is applied by a physical therapist on the proximal humeral head moving the humeral head posterior, inferior or lateral (distraction). An ultrasound transducer placed over the anterior shoulder joint provides imaging of the humeral head and the glenoid fossa. This manual intervention is repeated three times in each direction on each arm.
16076048|NCT02338778|Biological|MV|MV is an intravenous intralipid suspension with 5 various vaccines, including DPT (diphtheria, pertussis, and tetanus ), typhoid, Staphylococcus aureus, paratyphoid A and B. Accessories include microbial A, lecithin, Twain-80, span 20 and soy-bean oil for injection. Inject 0.5 ml of the mixture subcutaneously every week. Best reaction after injection was defined as showing regional red and swollen at the injection point and mild fever and to achieve this, dose increasing or reduction is acceptable.
16076049|NCT02338778|Other|Standard Treatment|Patient will receive a comprehensive histological and imaging check up to evaluate the histological type, stage of the disease and performance status. Then the patient will receive standard treatment, in brief, surgical resection for early stage patients and systemic treatment including chemotherapy for advanced stage patients, according to NCCN guide line.
16076050|NCT02338765|Behavioral|mHealth Physical Activity|
16076051|NCT02338765|Behavioral|Buddy-partnered exercise|
16076052|NCT02338752|Biological|MV|MV is an intravenous intralipid suspension with 5 various vaccines, including DPT (diphtheria, pertussis, and tetanus ), typhoid, Staphylococcus aureus, paratyphoid A and B. Accessories include microbial A, lecithin, Twain-80, span 20 and soy-bean oil for injection. Inject 0.5 ml of the mixture subcutaneously every week. Best reaction after injection was defined as showing regional red and swollen at the injection point and mild fever and to achieve this, dose increasing or reduction is acceptable.
16076053|NCT02338752|Other|Standard Treatment|Patient will receive a comprehensive histological and imaging check up to evaluate the histological type, stage of the disease and performance status. Then the patient will receive standard treatment, in brief, surgical resection for early stage patients and systemic treatment including chemotherapy for advanced stage patients, according to NCCN guide line.
16076054|NCT02338739|Behavioral|REC; Outreach if Failure|Routine education and counseling (REC) services, delivered per Kenya Ministry of Health Guidelines; followed by standard of care (SOC) outreach to encourage return to clinic for patients 14 days late for a scheduled visit in year 1.
16076055|NCT02338739|Behavioral|REC; SMS + Voucher if Failure|Routine education and counseling services, delivered per Kenya Ministry of Health (MOH) Guidelines; followed by SMS text messages for patients and reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients 14 days late for a scheduled visit in year 1.
16076056|NCT02338739|Behavioral|REC; Navigator if Failure|REC services, delivered per Kenya MOH Guidelines; followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit
16076057|NCT02338739|Behavioral|SMS; Outreach if Failure|SMS text messages for patients; followed by SOC outreach for patients 14 days late for a scheduled visit
16076058|NCT02338739|Behavioral|SMS; Outreach if Failure; Stop SMS if Success|SMS text messages for patients, followed by SOC outreach for patients 14 days late for a scheduled visit, and discontinuation of SMS text messages if never 14 days late
16076059|NCT02338739|Behavioral|SMS; SMS+Voucher if Failure|SMS text messages for patients, followed by reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients 14 days late for a scheduled visit in year 1.
16076060|NCT02338739|Behavioral|SMS; SMS+Voucher if Failure; Stop SMS if Success|SMS text messages for patients, followed by reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients 14 days late for a scheduled visit in year 1, and discontinuation of SMS text messages if never 14 days late
16076061|NCT02338739|Behavioral|SMS; Navigator if Failure|SMS text messages for patents, followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit
16076062|NCT02338739|Behavioral|SMS; Navigator if Failure; Stop SMS if Success|SMS text messages for patents, followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit, and discontinuation of SMS text messages if never 14 days late
16076063|NCT02338739|Behavioral|Voucher; Outreach if Failure|Reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients, followed by SOC outreach for patients 14 days late for a scheduled visit
16076064|NCT02338739|Behavioral|Voucher; Outreach if Failure; Stop Voucher if Success|Reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients, followed by SOC outreach for patients 14 days late for a scheduled visit, and discontinuation of voucher for patients if never 14 days late
16076065|NCT02338739|Behavioral|Voucher; SMS+Voucher if Failure|Reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients, followed by SMS text message and reimbursement (KSH 400) for transport to the clinic for patients 14 days late for a scheduled visit
16076066|NCT02338739|Behavioral|Voucher; SMS+Voucher if Failure; Stop Voucher if Success|Reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients, followed by SMS text message and reimbursement (KSH 400) for transport to the clinic for patients 14 days late for a scheduled visit, and discontinuation of voucher for patients if never 14 days late
16076334|NCT02336737|Drug|Isosulfan blue dye|Injection of a single dose of isosulfan blue dye
16076335|NCT02336724|Drug|Famitinib|
16076067|NCT02338739|Behavioral|Voucher; Navigator if Failure|Reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients, followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit
16076068|NCT02338739|Behavioral|Voucher; Navigator if Failure; Stop Voucher if Success|Reimbursement at a fixed amount (KSH 400) for transport to the clinic for patients, followed by Peer Navigator (tailored outreach and support) for patients 14 days late for a scheduled visit, and discontinuation of voucher for patients if never 14 days late
16076069|NCT02338726|Other|Gynecological examination|Comparison of questionnaires and gynecological examination
16076070|NCT02338713|Drug|Calcichew D3|Calcium 500 mg and vitamin D3 1000 IU chewable tablets
16076071|NCT02338713|Drug|Noncarbonated Water|Noncarbonated water 200 mL
16076072|NCT02338700|Biological|MV|MV is an intravenous intralipid suspension with 5 various vaccines, including DPT (diphtheria, pertussis, and tetanus ), typhoid, Staphylococcus aureus, paratyphoid A and B. Accessories include microbial A, lecithin, Twain-80, span 20 and soy-bean oil for
16076073|NCT02338700|Other|standard treatment|Patient will receive a comprehensive histological and imaging check up to evaluate the histological type, stage of the disease and performance status. Then the patient will receive standard treatment, in brief, surgical resection for early stage patients and systemic treatment including chemotherapy for advanced stage patients, according to NCCN guide line.
16076074|NCT02338687|Dietary Supplement|calcium|one chewable tablet daily, at bedtime, containing 500 mg elemental calcium (1250 mg calcium carbonate)
16076075|NCT02338687|Behavioral|Educational sessions|Women will participate in at least 2 interactive group educational sessions lasting 30 minutes each. Session content: importance of calcium during pregnancy and how to modify their diets to include calcium-rich foods that are available locally
16076076|NCT02338674|Drug|Tenofovir and telbivudine|tenofovir and telbivudine administered at least 48 weeks
16076077|NCT02338674|Drug|Tenofovir|tenofovir administered at least 48 weeks
16076078|NCT02338661|Device|SBG hip stem|
16076079|NCT02338648|Drug|SUN-131 1.5% TDS|Active transdermal patch
16076080|NCT02338648|Drug|Placebo TDS|Placebo transdermal patch for blinding
16076081|NCT02338635|Drug|Ursodeoxycholic Acid|Inhibition of ER stress (Ursodeoxycholic Acid)
16076082|NCT02338622|Drug|olaparib|olaparib BD
16076083|NCT02338622|Drug|AZD5363|AZD5363 BD
16076084|NCT02338609|Drug|Everolimus|Blood sample and Tanner Stage assessment
16076085|NCT02338609|Drug|Envirolimus drug class as prescribed by Physician|At the discretion of the investigator, patients may be treated with commercially available everolimus, as per local product information/ standard of care.
16076086|NCT02338596|Procedure|Total hip replacement|"Simultaneous bilateral sequential total hip arthroplasties under the same anesthetic.
~Randomization to treatment with an ultra-short or a convnetional cementless stem was accomplished with use of study numbers in sealed envelope, which were opened in the operating room before the skin incision was made.
~The pore size was 250㎛. A 28-mm-diameter Biolox forte ceramic femoral head (CeramTec AG, Polchingen, Germany) ) was used in all hips. A cementless cup and a 28mm internal-diameter Biolox forte ceramic liner was used in all hips in both groups."
16076087|NCT02338583|Device|Echelon Flex™ 45 and 60 Powered ENDOPATH® Stapler Articulating Endoscopic Linear Cutter|
16076088|NCT02338570|Drug|Everolimus|Patients will start study treatment on day 1 and will be treated with daily doses of everolimus (10 mg daily tablets).
16076089|NCT02338557|Device|motor relearning programme|MRP exercises for training of Wrist Extensors, Extension of wrist and holding objects, training of supination of forearm, opposition of thumb, cupping of hand and training of manipulation of the objects
16076090|NCT02338557|Device|MIRROR THERAPY|Mirror therapy in which patient was seated close to the table in front of mirror (35x35 cm). The involved hand was placed behind the mirror. : the practice consisted of intransitive exercises as Hand opening, Wrist extension and flexion, Forearm pronation and supination, Hand sliding on a flat surface. During the session patient were asked to try to do the same movement with the paretic hand while they were moving the non-paretic hand.In both the groups total treatment was given for 1 hour/day for 6 days/week
16076091|NCT02338544|Drug|0.1% Adapalene / 2.5% Benzoyl peroxide|Epiduo® gel containing 0.1% adapalene + 2.5% benzoyl peroxide dispensed from a pump.
16076092|NCT02338531|Drug|PF-03084014|
16076093|NCT02338531|Procedure|Breast cancer surgery|
16076094|NCT02338518|Drug|oxaliplatin|"oxaliplatin 100 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group and SOX group.
~Intravenous oxaliplatin 130 mg/m2 was administered on day 1 of every cycle in SOX group."
16076095|NCT02338518|Drug|etoposide|etoposide 80 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group.
16076096|NCT02338518|Drug|pharmorubicin|pharmorubicin 30 mg/m2 was administered from the celiac artery on day 1 of every cycle in SEEOX group.
16076097|NCT02338518|Drug|S-1|80 mg of oral S-1 per square meter of body-surface area per day was given for 2 weeks in both SEEOX and SOX groups.
16076098|NCT02338505|Device|Telelap ALF-X|"Patients placed in the dorsal lithotomic position with both legs supported in Allen stirrups with a Trendelenburg tilt. After achieving pneumoperitoneum (12mmHg) through a trans umbilical open access technique, intra-abdominal visualization was obtained with a 10mm 0° HD 3D telescope. During the trocar placement the operative room nurses supported the surgeon in the docking procedures approaching the robotic arms to the operative table, in places established for pelvic surgery. The cockpit is located in one corner of our square shape room; the operative table is surrounded by the three robotic arms unit.
~Through the teleassisted operative ports we could make use of several type of instruments. Movements of both instruments and optic were completely carried out by the surgeon from the cockpit according to the needs of the procedure."
16076099|NCT02338492|Device|Photodynamic Bone Stabilization System|Treatment of impending and actual pathological fractures of the humerus
16076100|NCT02338466|Drug|rt-PA|0,9 mg/kg of rt-PA is infused intravenously 60 minutes, with 10% of the total dose administered as an initial intravenous bolus.
16076101|NCT02338466|Drug|tenecteplase|"Tenecteplase is under the form of powder and solvent for solution for injection.
~The maximum duration of this treatment is 15 seconds by a single bolus intravenous injection (0, 25 mg/kg)."
16076336|NCT02336711|Radiation|dose escalation|molecular imaging based radiotherapy dose escalation
16076874|NCT02332824|Drug|TAK-272 Placebo|TAK-272 placebo-matching tablets
16076102|NCT02338453|Behavioral|Active Attention Bias Modification Treatment|Attention bias is modified using a dot-probe task. Each trial begins with a fixation cross presented in the center of the screen for 500 ms. Next, participants are presented with two stimuli depicting two faces of the same individual for 500 ms, either of two neutral faces or with one neutral face and one disgust face (i.e., the socially-threatening stimulus). Then, one of two optional probes appears in the location former occupied by one of the faces. Participants are instructed to discriminate as fast as possible between the two variants of the probe, without compromising accuracy, by pressing on two corresponding keys. The probe remains on the screen until the participant responds, after which the next trial commences. This protocol is designed to divert attention away from socially-threatening stimuli as in 80% of trials the probe appears in the location formerly occupied by the neutral face. The remaining 20% of trials include two neutral faces, with no predictive value
16076103|NCT02338453|Behavioral|Placebo Attention Bias Modification Treatment|the Placebo ABMT is similar to the active ABMT except that this protocol is not designed to divert attention away from or toward socially-threatening stimuli as in 40% of trials the probe appears in the location formerly occupied by the neutral face and in 40% it appears in the location formally occupied by the threatening face. The remaining 20% of trials include two neutral faces
16076104|NCT02338440|Drug|lipoprostaglandin E1|Blood sampling before administration (baseline), between 1 hour to 72 hours from administration (plateau 1), 72 hours after engraftment (plateau 2), when the clinician determine to do blood sampling because of change of kidney/liver function change (optional 1), 72 hours from the change of lipoprostaglandin E1 concentration change (optional 2)
16076105|NCT02338427|Other|Immunohistochemistry|
16076106|NCT02338427|Other|Proteomic analysis|
16076107|NCT02338414|Drug|Romiplostim|Subcutaneous Romiplostim (weekly injection) -> if titrated with maintaining PLT count between 50-200 x 10^9/L -> Subcutaneous Romiplostim (biweekly injection)
16076108|NCT02338401|Dietary Supplement|Omega-3 Complete|Fish Oil Capsules
16076109|NCT02338401|Dietary Supplement|Placebo Pill|Olive Oil Capsules
16076110|NCT02338388|Procedure|cesarean section technique|Comparing three different types of suturing the uterus at Cesarea section
16076111|NCT02338375|Biological|Cartistem|Cartistem is allogenic umbilical cord blood-derived stem cell product. Cartistem is 500uL/cm2 applied according to the lesion.
16076112|NCT02338362|Drug|Fluticasone propionate inhaler|fluticasone propionate 250 µg metered-dose inhaler
16076113|NCT02338362|Drug|Saline placebo inhaler|saline metered dose inhaler
16076114|NCT02338349|Drug|Elacestrant|
16076115|NCT02338336|Drug|Nowarta110|Nowarta110 contains fig extract as the main drug substance, and colloidal silver is used as a medium for penetration of fig extract into the wart lesion. Liquid for topical administration.
16076116|NCT02338336|Drug|Placebo|Matching placebo liquid for topic administration.
16076117|NCT02338323|Drug|Febuxostat|It acts as an inhibitor of xanthine oxidase, thus lowering urate concentrations in the body
16076118|NCT02338323|Drug|Benzbromarone|It is structurally related to the antiarrhythmic amiodarone, and it is a uricosuric agent and non-competitive inhibitor of xanthine oxidase
16076119|NCT02338310|Drug|Aromatase Inhibitors|Choice of AI is according to centre policy; any brand can be used
16076120|NCT02338297|Procedure|TACE|Transarterial chemoembolisation (TACE)
16076121|NCT02338297|Drug|EGM|Occlude arterioportal shunts(APS) with ethanol/gelfoam mixture(EGM)
16076122|NCT02338297|Drug|PVA|Occlude arterioportal shunts(APS) with PVA
16076123|NCT02338284|Other|ultrasound of globe|"A high resolution 7.5 -10 MHz linear array ultrasound transducer probe will be used. A large amount of standard water-soluble ultrasound transmission gel will be applied to the patient's closed eyelid. The globe will be scanned in the transverse plane.• The ONSD will be measured at a predefined point 3 mm posterior to the globe in both eyes. • Measurement of the ONSD for both eyes will be done and the average the two measurements will be taken.
~A value > 58mm (from reference 1) will be considered as indicative of increased ICP and the primary ICU team will be informed for rapid measures to decrease ICP or urgent imaging of the CNS."
16076124|NCT02338271|Other|autologous adipose derived mesenchymal stem cell|autologous adipose derived mesenchymal stem cell (2 x 10^7 cells/mL /vial or 4 x 10^7 cells/mL /vial) and Tissuefill (hyaluronic acid derivatives) 1mL/syringe
16076125|NCT02338258|Device|Anti-rotational plate|
16076126|NCT02338258|Device|Exchanged Intramedullary nailing|
16076127|NCT02338245|Drug|ASLAN001|ASLAN001 400mg BID
16076128|NCT02338245|Drug|Lapatinib|Lapatinib 1250mg QD
16076129|NCT02338245|Drug|Capecitabine|Capecitabine 1000mg/kg BID days 1-14 of a 21-day cycle
16076130|NCT02338232|Drug|Telmisartan|
16076131|NCT02338219|Other|postpartum female pelvic floor muscle affection|"transperineal pelvic floor ultrasound applied for the submitted 120 women primiparae (40 women after normal vaginal delivery), (40 women after urgent cesarean section), (40 women after elective cesarean section), in early postpartum period (48 to 72) hours postpartum, to evaluate levator ani morphology."
16076132|NCT02338219|Other|postpartum sexual function in Egyptian women.|answering of the validated female sexual function index (F.S.F.I) three months postpartum period for same cases submitted to ultrasound.
16076133|NCT02338206|Drug|Growth hormone|
16076134|NCT02338193|Drug|DAPA/MET XR|final dose- 5 mg dapagliflozin/1000 mg glucophage XR BID for 20-24 weeks
16076135|NCT02338193|Drug|DAPA|10 mg dapagliflozin QD for 20-24 weeks
16076136|NCT02338193|Drug|MET XR|1000 mg Metformin XR BID for 20-24 weeks
16076137|NCT02338180|Other|proximal preventive sealants|On sound mesial surfaces of first permanent molars adjacent to a caries active lesion of second primary molar, after 4-6 days with an orthodontic separating rubber ring around the approximal contact area. The test site was isolated with cotton rolls or a rubber dam. The surface of 6m was etched with 35% phosphoric acid for 20 sec, washed with water and then air-dried. The sealant (Concise Sealant; 3M ESPE) was applied and light-cured for 20 sec each on the occlusal, buccal and lingual sides. After polymerization, the sealant was inspected for complete coverage.
16076184|NCT02337855|Biological|Sm-TSP-2/Alhydrogel/GLA-AF|Sm-TSP-2/Alhydrogel/GLA-AF. Group B: single dose intramuscular (IM) 10mcg Sm-TSP-2/Alhydrogel®/GLA-AF on Day 1, 57 and 113. Group E: single dose intramuscular (IM) 30mcg Sm-TSP-2/Alhydrogel®/GLA-AF on Day 1, 57 and 113. Group H: single dose intramuscular (IM) 100mcg Sm-TSP-2/Alhydrogel®/GLA-AF on Day 1, 57 and 113.
16077132|NCT02330926|Other|standard care|
16076138|NCT02338180|Other|proximal therapeutic sealant|On mesial surfaces of first permanent molars with caries active lesion adjacent to a caries active lesion of second primary molar , after 4-6 days with an orthodontic separating rubber ring around the approximal contact area. The test site was isolated with cotton rolls or a rubber dam. The surface of 6m was etched with 35% phosphoric acid for 20 sec, washed with water and then air-dried. The sealant (Concise Sealant; 3M ESPE) was applied and light-cured for 20 sec each on the occlusal, buccal and lingual sides. After polymerization, the sealant was inspected for complete coverage.
16076139|NCT02338167|Procedure|Blood sampling|A blood sample will be taken during a routine blood draw
16076140|NCT02338141|Device|Portable colposcopy (Cerviscope)|HPV-positive women will be evaluated with portable colposcopy (with a novel portable colposcope known as the Cerviscope) after visual inspection with acetic acid and prior to biopsy in the experimental group.
16076141|NCT02338141|Device|Conventional colposcopy (Wallach Zoomscope)|HPV-positive women will be evaluated with conventional colposcopy (with the Wallach Zoomscope) after visual inspection with acetic acid and prior to biopsy per usual standard of care.
16076142|NCT02338115|Drug|Paclitaxel 80mg/m2 weekly x 12 weeks|
16076143|NCT02338102|Other|Saline mixture|premeasured salt packets mixed with distilled water
16076144|NCT02338089|Drug|Oxytocin|Oxytocin, 100 micromolar solution
16076145|NCT02338076|Drug|Petrolatum application under occlusion|"Day 0 study patients will have 1 patch applied to either back or thighs ( containing 2 wells)
~1 well will be empty and the other well will contain petrolatum
~Day 3 patches will be removed and 3 skin biopsies will be performed 1 biopsy from normal skin at a distance from the patch
~1 biopsy each from under the 2 wells of the patch ( so 1 biopsy from skin that was occluded with petrolatum and 1 biopsy from skin that was occluded without petrolatum)"
16076146|NCT02338063|Behavioral|Virtual Reality|4-session group intervention including affect management training as well as sexual health skills training to prevent the transmission of HIV. Group will practice skills using 3-D goggles for some activities.
16076147|NCT02338063|Behavioral|Health Promotion|4-session group intervention including affect management training as well as sexual health skills training to prevent the transmission of HIV. Group will practice skills using traditional role-plays for some activities.
16076148|NCT02338050|Biological|Moxetumomab Pasudotox|
16076149|NCT02338037|Procedure|Therapeutic Conventional Surgery|Undergo tumor resection
16076150|NCT02338037|Procedure|Biopsy|Undergo biopsy
16076151|NCT02338037|Drug|Eribulin Mesylate|Given IV
16076152|NCT02338037|Procedure|Microdialysis|Undergo intracerebral microdialysis
16076153|NCT02338037|Other|Pharmacological Study|Correlative studies
16076154|NCT02338024|Behavioral|Modified Antiretroviral Treatment Access Study intervention|
16076155|NCT02338011|Drug|Gefitinib|Gefitinib was given 250mg per day. Dose reduction was allowed for intolerable adverse effects such as rash(grade 4)、diarrhea(grade 3-4) or non hematological toxicity(grade 3-4) from 250mg per day to 250mg every other day then to 250mg every three days if needed.
16076156|NCT02338011|Radiation|WBRT|WBRT was delivered in 3.0 Gy fractions once per day 5 days per week to a total dose of 30Gy (10 fractions).
16076157|NCT02337998|Other|load carriage|
16076158|NCT02337985|Drug|Prednisone|Given PO
16076159|NCT02337985|Biological|Rituximab|Given IV
16076160|NCT02337985|Drug|Etoposide|Given IV
16076161|NCT02337985|Drug|Doxorubicin Hydrochloride|Given IV
16076162|NCT02337985|Drug|Vincristine Sulfate|Given IV
16076163|NCT02337985|Drug|Cyclophosphamide|Given IV
16076164|NCT02337985|Biological|Filgrastim|Given SC
16076165|NCT02337985|Biological|Lentivirus Vector rHIV7-shI-TAR-CCR5RZ-transduced Hematopoietic Stem/Progenitor Cells|Given IV
16076166|NCT02337972|Drug|povidone-iodine 4%|Prior to each injection and before the use of povidone-iodine drops, a conjunctival culture will be taken
16076167|NCT02337959|Radiation|Radiation|Live subjects will receive two x-rays, one with predicate detector and one using the GOS or CsI investigational detector. Multiple exams (head, chest, legs, etc) were made on the cadavers. Each exam area received one x-ray using the predicate detector and two x-rays using both the GoS and the CsI investigational detectors.
16076168|NCT02337946|Drug|oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab|oxaliplatin (OXA), levofolinate calcium (l-LV), panitumumab: intra-venous infusion 5-FU: bolus and continuous intra-venous infusion
16076169|NCT02337946|Drug|oxaliplatin (OXA), levofolinate calcium (l-LV), 5-FU, panitumumab|
16076170|NCT02337933|Drug|Ursolic acid|Ursolic acid capsules of 150 mg extracted from rosemary, once a day before breakfast
16076171|NCT02337933|Drug|Placebo|Calcined magnesia capsules of 150 mg, once a day before breakfast
16076172|NCT02337907|Drug|Placebo|for blinding purposes
16076173|NCT02337907|Drug|Placebo|
16076174|NCT02337907|Drug|BI 409306|
16076175|NCT02337907|Drug|Donepezil|
16076176|NCT02337894|Dietary Supplement|Essential amino acids plus arginine|Flavored drink containing essential amino acids plus arginine.
16076177|NCT02337894|Dietary Supplement|Placebo|Flavored drink without essential amino acids plus arginine.
16076178|NCT02337881|Drug|nifedipen|The protocol for nifedipen in our units consists of 20 mg orally stat, followed by 10 mg orally every 6-8 hours for 48 to 72 hours as needed
16076179|NCT02337881|Drug|Sildenafil|sildenafil citrate will be administered vaginally in a dose of 25mg at 8 hourly intervals and both medications will be continued for 48-72 hours as indicated.
16076180|NCT02337868|Biological|HydroVax-001|HydroVax-001 West Nile Virus inactivated vaccine, alum-adsorbed given at doses of 1 mcg (low dose) and 4 mcg (high dose) IM on days 1 and 29
16076181|NCT02337868|Other|Placebo|0.9% Sodium Chloride Injection diluent will be given IM on days 1 and 29
16076182|NCT02337855|Other|Placebo|Placebo: normal saline for parenteral administration. Group C. Group F, and Group I: single dose intramuscular (IM) Placebo (normal saline (0.9% NaCl) on Day 1, 57 and 113.
16076183|NCT02337855|Biological|Sm-TSP-2/Alhydrogel|Sm-TSP-2/Alhydrogel. Group A: single dose IM 10mcg Sm-TSP-2/Alhydrogel® on Day1, 57 and 113. Group D: single dose intramuscular (IM) 30mcg Sm-TSP-2/Alhydrogel® on Day 1, 57 and 113. Group G: single dose intramuscular (IM) 100mcg Sm-TSP-2/Alhydrogel® on Day 1, 57 and 113.
16076248|NCT02337400|Behavioral|"Cognitive behavioral smoking reduction program Smoke_less"|Duration: 5 weeks, 4 sessions over 2,5 hours and 2 phone calls
16076185|NCT02337842|Biological|Norovirus GII.4 Challenge Pool CIN-1|Norovirus Challenge GII.4 Strain 031693. Cohort 1: receive single oral dose of GII.4 CIN-1 at 10^3 RT-PCR units. Cohort 2: single oral dose of GII.4 CIN-1 either at 10^2 or 5x10^3 RT-PCR units. Cohort 3: single oral dose of GII.4 CIN-1 at either 10^4, 10^3, 5x10^2 or 5x10^1 RT-PCR units. Cohort 4: single oral dose of GII.4 CIN-1 at either 5x10^4 or 5x10^3 or 10^3 or 10^2 or 10^4 or 5x10^2 or 5x10^1RT-PCR units.
16076186|NCT02337842|Other|Placebo|Placebo: 80 ml of sterile water for oral administration
16076189|NCT02337816|Procedure|laparoscopic surgery, obtainment of biological samples|
16076190|NCT02337803|Behavioral|Strength Training Program|The strength training program consists of 6 exercises using resistance bands three times a week
16076191|NCT02337803|Behavioral|Usual Care|Will continue daily physical activity and complete surveys online
16076192|NCT02337764|Drug|TVP-1012 1mg|TVP-1012 1mg Tablets
16076193|NCT02337751|Drug|TVP-1012 1mg|TVP-1012 1mg Tablets
16076194|NCT02337738|Drug|TVP-1012 1mg|TVP-1012 1mg Tablets
16076195|NCT02337738|Drug|TVP-1012 0.5mg|TVP-1012 0.5mg Tablets
16076196|NCT02337738|Drug|Placebo|Placebo Tablets
16076197|NCT02337725|Drug|TVP-1012|TVP-1012 1mg Tablets
16076198|NCT02337725|Drug|Placebo|Placebo tablets
16076199|NCT02337712|Radiation|q.d. RT|65 Gy in 26 fractions
16076200|NCT02337712|Radiation|b.i.d.RT|45 Gy in 30 fractions
16076201|NCT02337712|Drug|etoposide and cisplatin|etoposide and cisplatin concurrent with radiotherapy
16076202|NCT02337699|Device|Implantation with the commercially available Axium neurostimulator|
16076203|NCT02337699|Procedure|QST Testing|
16076204|NCT02337686|Other|Laboratory Biomarker Analysis|Correlative studies
16076205|NCT02337686|Biological|Pembrolizumab|Given IV
16076206|NCT02337686|Other|Pharmacological Study|Correlative studies
16076207|NCT02337686|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16076208|NCT02337660|Procedure|Liver biopsy|One ultrasound guided liver biopsy
16076209|NCT02337660|Other|Pancreatic clamp|I.v. infusions of somatostatin and insulin (basal rate) for will be adminstered for 3 hours. Glucagon will administered for 3 hours in total with infusion rates at a basal and a high physiological rate for 1.5 hours each.
16076210|NCT02337647|Other|DCDC App|The DCDC app is an experimental software that allows users to map their visual distortions on a tablet computer.
16076211|NCT02337634|Drug|Placebo|Taken as two 150mg capsules BID for 2 weeks, then 300mg BID for remainder of the study.
16076212|NCT02337634|Drug|Milk Thistle|Taken as two 150mg capsules BID for 2 weeks, then 300mg BID for remainder of the study.
16076213|NCT02337621|Other|No intervention|
16076214|NCT02337608|Drug|GLPG1205|GLPG1205 daily dosing in the morning for 12 weeks
16076215|NCT02337608|Drug|Placebo|placebo daily dosing in the morning daily for 12 weeks
16076216|NCT02337595|Biological|CD45RA-depleted peripheral blood mononuclear cells|Infusion of escalating doses of CD45RA-depleted donor-derived allogeneic peripheral blood mononuclear cells
16076217|NCT02337582|Other|Opportunistic Breast cancer screening|Opportunistic breast screening offered to women attending clinics for non-breast health issues
16076218|NCT02337582|Other|Usual Care|No breast screening was explicitly offered to women attending clinics for non-breast health issues, unless the health care provider felt that it was appropriate
16076219|NCT02337569|Drug|NPC-02|
16076220|NCT02337569|Drug|Placebos|
16076221|NCT02337556|Other|Peptamen Bariatric|Commercially available enteral diet
16076222|NCT02337556|Other|Replete|Commercially available enteral diet
16076223|NCT02337543|Drug|NEO6860|NEO6860 is an NCE acting as a TRPV1 antagonist
16076224|NCT02337543|Drug|Placebo|Placebo
16076225|NCT02337530|Drug|Selumetinib|
16076226|NCT02337530|Drug|Pemetrexed|
16076227|NCT02337530|Drug|Cisplatin|
16076228|NCT02337530|Drug|Carboplatin|
16076229|NCT02337517|Other|Laboratory Biomarker Analysis|Correlative studies
16076230|NCT02337517|Drug|Vismodegib|Given PO
16076231|NCT02337504|Other|community-based care|Will receive HIV care in the community and not in the clinic which is the normal standard of care
16076232|NCT02337491|Drug|Pembrolizumab|
16076233|NCT02337491|Drug|Bevacizumab|
16076234|NCT02337478|Drug|Vincristine Sulfate Liposome|Given via injection
16076235|NCT02337478|Other|Laboratory Biomarker Analysis|Correlative studies
16076236|NCT02337465|Device|Cone-Beam Computed Tomography|Undergo kilo-voltage cone beam computed tomography
16076237|NCT02337465|Radiation|3-Dimensional Ultrasound-Guided Radiation Therapy|Undergo ultrasound-guided radiation therapy
16076238|NCT02337452|Other|Questionnaire Administration|Ancillary studies
16076239|NCT02337452|Behavioral|Web Site|Communicate via family outreach program website
16076240|NCT02337439|Behavioral|Sensory Information Processing Training|Computer exercises requiring identification of visual stimuli on computer screen and response with keyboard
16076241|NCT02337439|Behavioral|Active Control Training|Commercially available educational software
16076242|NCT02337426|Drug|Dimethyl Fumarate|Given PO
16076243|NCT02337426|Drug|Temozolomide|Given PO
16076244|NCT02337426|Radiation|Radiation Therapy|Undergo radiation therapy
16076245|NCT02337413|Drug|Polyethylene glycol 3350|Patients will initially receive three days of high dose PEG3350 treatment (1.5gr/kg up to 100gr maximum) and then will be stepped down to 0.8gr/kg subsequently and tapered accoriding to stool consistency and frequency.
16076246|NCT02337413|Behavioral|Constipation behavioral therapy|Patients in the active group will receive dietary instruction as to fiber content, as well as behavioral therapy including active sitting on the toilet to attempt defaction following meals.
16076247|NCT02337413|Behavioral|Urotherapy|Patients will be guided for appropriate drinking and toilet habits, and will start with timed voiding.
16076253|NCT02337361|Behavioral|Electronic SBI|"Bilingual (English and Spanish) e-SBI with four key components:
~1) Beverage-specific drink size assessment; 2) Individualized feedback on the woman's drink sizes and on discrepancies between her drink size and the standard size for each beverage; 3) A personalized plan for reducing consumption which includes goal setting; and 4) an analysis of high risk situations for drinking alcohol, and suggested coping strategies."
16076254|NCT02337348|Other|Optical coherence tomography|Preintervention imaging
16076255|NCT02337348|Radiation|Coronary angiography|Conventional coronary intervention
16076256|NCT02337322|Drug|Dolutegravir|
16076257|NCT02337322|Drug|Darunavir/r|
16076258|NCT02337309|Drug|SF1126|SF1126 in IV form with be given to patients on this study.
16076259|NCT02337296|Behavioral|ADHERE|"ADHERE entails a face-to-face 30 minute session during week 1 while in the clinic/office and three subsequent ADHERE phone calls for 10 minutes each, weekly during weeks 2-4 to promote symptom management and adherence to their oral agent regimen. The face-to-face intervention and phone interactions will consist of Motivational Interviewing and Cognitive Behavioral Therapy interaction strategies. Each patient will be given a Medication Management and Symptoms Management Toolkit, to assist with symptom management at home.
~All patients (intervention and control) receive weekly assessments of symptom severity and oral agent adherence (weeks 2-7). At exit (week 8), all patients receive an assessment of depressive symptoms, self-efficacy, beliefs, motivation, symptom severity, and adherence."
16076260|NCT02337283|Drug|BI 425809|Tablets
16076261|NCT02337283|Drug|Placebo|Tablets
16076262|NCT02337270|Biological|Ad5Ag85A|Aerosol administration of Ad5Ag85A
16076263|NCT02337257|Drug|Cholecalciferol|subjects will receive one pill per day which contains 4000 IU/d for 16 weeks
16076264|NCT02337257|Drug|Placebo|subjects will receive placebo one pill per day for 16 weeks
16076265|NCT02337244|Device|Zimmer Persona Total Knee System|No Intervention
16076266|NCT02337231|Dietary Supplement|soybean oil and borage oil|Compare the capacity of humans with GG, GT and TT genotypes at rs174537 taking soybean and borage oils to metabolize medium chain PUFAs.
16076267|NCT02337218|Device|SENSUS Pain Management System|An electrical stimulation device worn on a band around the leg. This device was determined to be non-significant risk by the FDA.
16076268|NCT02337205|Drug|KX2-391 Ointment|KX2-391 Ointment will be applied at a predetermined concentration to the treatment area for a predetermined time period.
16076269|NCT02337192|Drug|Curcumin|
16076270|NCT02337192|Device|LED|
16076271|NCT02337192|Drug|Surfactant|
16076272|NCT02337192|Drug|DMSO + water|
16076273|NCT02337192|Drug|Chlorhexidine gluconate|
16076274|NCT02337179|Procedure|Voluntary medical male circumcision|Male Circumcision Under Local Anesthesia using the Forceps Guided Method
16076275|NCT02337166|Device|a gel containing 4mg/ml rhFGF-2 in sodium hyaluronate|0.2ml of a gel containing 4mg/ml rhFGF-2 in sodium hyaluronate MW 1.3 x 106
16076276|NCT02337166|Procedure|Periodontal flap surgery|
16076277|NCT02337140|Device|Pacemaker SORIN Group KORA DR|
16076278|NCT02337140|Procedure|transcatheter aortic valve implantation (TAVI)|
16076279|NCT02337127|Drug|Lamivudine|Lamivudine, 100mg/day, per os
16076280|NCT02337114|Behavioral|Acceptance and Commitment Therapy|A psychotherapeutic intervention that aims to enhance individuals' willingness to have difficult experiences but persist with behaviours that reflect what is important to them.
16076281|NCT02337114|Behavioral|Treatment as Usual|A client-centred goal planning system linked to community reintegration and based on a holistic rehabilitation model including counselling, medical management, cognitive behavioural therapy and pharmacotherapy.
16076282|NCT02337101|Other|Enhanced Usual Care (EUC)|All patients will have a brief clinical psychiatric and neurological assessment in order to determine eligibility, and will be provided with information and advice about typical post-concussional symptoms, the typical recovery process and the use of pain medication.
16076283|NCT02337101|Behavioral|EUC + Early intervention programme|"All patients will have a brief clinical psychiatric and neurological assessment in order to determine eligibility, and will be provided with information and advice about typical post-concussional symptoms, the typical recovery process and the use of pain medication.
~The early intervention programme will be interdisciplinary and will mainly be provided by an occupational therapist and a physiotherapist under supervision of a neuropsychologist. It will be based on psychoeducation and principles from Cognitive Behavioral Therapy and Graded Exercise Therapy and targeted to patients' individual goals.
~Patients will receive 8 weekly treatment sessions (3 group based and 5 individual sessions). Intervention will start approximately 4-5 months after the concussion."
16076284|NCT02337088|Procedure|Delayed cord clamping at 30 seconds|For subjects enrolled in the 30 second arm, the umbilical cord will be clamped at exactly 30 seconds after delivery
16076285|NCT02337088|Procedure|Delayed cord clamping at 60 seconds|For subjects enrolled in the 60 second arm, the umbilical cord will be clamped at exactly 60 seconds after delivery
16076286|NCT02337075|Behavioral|PATH program|A brief education session, use of a wearable physical activity tracker, and physical activity mentoring by an Activity Mentor every 2 weeks.
16076287|NCT02337075|Device|Activity Mentor|
16076288|NCT02337062|Drug|APD421|
16076289|NCT02337062|Drug|Placebo|
16076290|NCT02337036|Other|Pharmacokinetic|Taking blood samples for an Pharmacokinetic of tacrolimus in Paediatric Liver Transplant Patients treated with tacrolimus
16076291|NCT02337036|Other|Pharmacogenetic|Pharmacogenetic study
16076292|NCT02337036|Drug|Tacrolimus|These Patients are treated with tacrolimus after the Liver Transplantation
16076293|NCT02337023|Radiation|Brain scintigraphy with injection of Neurolite® (ECD)|Brain scintigraphy with injection of Neurolite® (ECD) 1 injection
16076294|NCT02337010|Device|CeVOX|Central venous saturation was continuously monitored by using a CeVOX monitor (Pulsion Medical Systems, Munich, Germany). The CeVOX probe (PV2022-37; Pulsion Medical Systems, Munich, Germany) was inserted into the internal jugular central venous catheter as described in the user's manual.
16076295|NCT02337010|Device|CVP|Central venous pressure was continuously monitored by using a central venous catheter. The probe was inserted into the internal jugular central vein as described in the user's manual.
16076409|NCT02336217|Other|Placebo Comparator general instructions|The Placebo Comparator Group receives general instructions but not the complete management algorithm
16076296|NCT02337010|Drug|Fluid bolus|If hypovolaemia was suspected fluid bolus was given in the form of 250 ml hydroxyethyl starch solution (HES, 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride, Voluven, Fresenius Kabi, Germany) over 15 minutes.
16076297|NCT02337010|Drug|Vasopressor|If hypotension was present it was treated with vasopressor as 10 mcg bolus or continuous infusion of norepinephrine (Arterenol® Sanofi, Germany).
16076298|NCT02336997|Procedure|FAT-GRAFT|Liposuction will be performed and autologous fat graft will be harvest after washing with saline. Patients will receive autologous fat graft transplantation subdermally to expanded skin at the density of 0.1 ml/cm2.
16076299|NCT02336997|Procedure|SVF-TRANSPLANTATION|Liposuction will be performed. SVF will be separated from autologous fat graft by collagenase digestion. Patients will receive resuspended SVF transplantation subdermally to expanded skin at the density of 1*10e6 cells/cm2.
16076300|NCT02336997|Procedure|PLACEBO|Saline will be injected into expanded skin.
16076301|NCT02336984|Biological|HER-2 pulsed DC1|Vaccine administered weekly, with no more than 4 weeks delay over the course of 6 vaccines.
16076302|NCT02336984|Drug|trastuzumab|The loading dose of Trastuzumab will be 8 mg/kg and the maintenance dose given week 4 will be 6 mg/kg, both standard doses of trastuzumab.
16076303|NCT02336984|Drug|pertuzumab|Pertuzumab 420 mg IV will be given at the same time as trastuzumab.
16076304|NCT02336971|Behavioral|CBCT for PTSD|CBCT consists of three phases of treatment: Phase 1: treatment orientation and education about PTSD and its related intimate relationship problems Phase 2: behavioral communication skills training Phase 3: cognitive interventions based on Cognitive Processing Therapy (CPT)
16076305|NCT02336971|Behavioral|Prolonged Exposure|PE consists of: psychoeducation and some limited distress management training, but emphasizes the role of imaginal and in vivo exposure in treating PTSD.
16076306|NCT02336958|Drug|intermediate cervical plexus block ropivacaine|20ml ultrasound guided intermediate cervical plexus block.
16076307|NCT02336958|Drug|pericarotidal infiltration (active comparator) ropivacaine|5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration.
16076308|NCT02336958|Drug|jugular infiltration prilocaine|5ml prilocaine 1% jugular infiltration for wound drainage.
16076309|NCT02336958|Drug|pericarotidal infiltration (placebo comparator) saline|5ml saline 0.9% (placebo comparator): pericarotidal infiltration.
16076310|NCT02336945|Device|Abbott Sensor Based Glucose Monitoring System-Professional|Subjects will wear 2 glucose sensors while going about daily activities and adhering to establish diabetes treatment plan. This is not a treatment study.
16076311|NCT02336919|Behavioral|Txt2Prevent|A 60-day text messaging program called Txt2Prevent (see description in the arm description).
16076312|NCT02336906|Drug|polyethylene glycol 3350|Patients will initially receive three days of high dose PEG3350 treatment (1.5gr/kg up to 100gr maximum) and the stepped down to 0.8gr/kg subsequently tapered according to stool consistency and frequency.
16076313|NCT02336906|Behavioral|Constipation behavioral therapy|Patients in the active group will receive dietary instruction as to fiber content, as well as behavior therapy including active sitting on the toilet to attempt defacation following meals.
16076314|NCT02336906|Behavioral|Urotherapy|The children will be guided for appropriate drinking and toilet habits, and will start with timed voiding.
16076315|NCT02336893|Behavioral|Training|The final training was provided to a group of 34 residents --from internal medicine, anesthesiology, gynecology, and intensive care-- in charge of giving information to the patient's family members in the ICU. They were trained in the semi-structured interview PACIENTE (Present oneself and greet, Attend and listen, Call diagnosis, Inform treatment, Expose prognosis, Name introductory phrases to bad news, Take time to provide empathetic comfort, Explain an action plan involving the family) conjointly while participating in simulated difficult clinical cases with family members-actors. Four training programs were performed from February to September 2014.
16076316|NCT02336880|Behavioral|Internet-delivered cognitive behavioural therapy|
16076317|NCT02336867|Device|Closure clip (OTSC® Proctology)|
16076318|NCT02336854|Drug|Tacrobell tab. 2mg|
16076319|NCT02336854|Drug|Prograf cap. 2mg|
16076320|NCT02336841|Other|Treatment as usual + Recovery MANTRA|Participants in this group will receive the guided self-help intervention including video-clips, a workbook, and guidance from peer mentors, and treatment as usual.
16076321|NCT02336841|Other|Treatment as usual + feedback|Participants in this group will receive treatment as usual and feedback on their eating disorder symptoms.
16076322|NCT02336815|Drug|Selinexor|Fixed oral dose of 80 mg twice weekly (e.g., Monday and Wednesday or Tuesday and Thursday, etc.)
16076323|NCT02336815|Drug|Dexamethasone|20 mg was given with each dose of Selinexor.
16076324|NCT02336802|Behavioral|Avoidance experiment|Participants complete an avoidance task
16076325|NCT02336789|Other|fecal material|. All patients will undergo a screening colonoscopy and will be allocated to receive either 250 ml of diluted fecal material prepared from a screened donor, or an equivalent volume of normal saline (sham transplantation).
16076326|NCT02336789|Other|normal saline|All patients will undergo a screening colonoscopy and will be allocated to receive either 250 ml of diluted fecal material prepared from a screened donor, or an equivalent volume of normal saline (sham transplantation).
16076327|NCT02336776|Other|Functional electrical stimulation|"Functional electrical stimulation will be applied through self adhesive electrodes on the quadriceps muscle of both thighs, and these will be positioned at 60° of flexion and contained by a band for that exercise happen isometric form.
~Parameter settings in the electrical stimulator are as follows: 80 Hz frequency, 0.4 ms pulse, 10 s time on, 50-20 s time off, intensity according to the patient's tolerance but enough to cause visible muscle contraction. The total time of each session starts at twenty minutes and is increased every week a total thirty-four minutes at the end of the eighth week. Intervention will be held three times a week for eight weeks and during hemodialysis session."
16076328|NCT02336763|Radiation|External Beam Radiation Therapy|Undergo external beam radiation therapy
16076329|NCT02336763|Other|Laboratory Biomarker Analysis|Correlative studies
16076330|NCT02336750|Drug|Aprepitant|125mg D1, 80mg D2-3
16076331|NCT02336750|Drug|Mirtazapine|15mg D2-4
16076332|NCT02336737|Device|SiennaXP|Sub-cutaneous injection of SiennaXP magnetic marker, followed by lymph node localization using the SentiMag handheld magnetic probe
16076333|NCT02336737|Drug|Technetium Tc99m Sulfur Colloid|Injection of a single dose of radioisotope (Technetium Tc99m Sulfur Colloid)
16076337|NCT02336698|Drug|Placebo|Placebo will be administered once every 4 weeks for 16 weeks by subcutaneous (SC) injection (injection under the skin) into the thigh or abdomen.
16076338|NCT02336698|Drug|Fulranumab 1 mg|Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen.
16076339|NCT02336698|Drug|Fulranumab 3 mg|Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen.
16076340|NCT02336685|Drug|Placebo|Placebo will be administered once every 4 weeks for 16 weeks by subcutaneous (SC) injection (injection under the skin) into the thigh or abdomen.
16076341|NCT02336685|Drug|Fulranumab 1 mg|Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen.
16076342|NCT02336685|Drug|Fulranumab 3 mg|Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen.
16076343|NCT02336685|Drug|Opioid|Opioids will be administered as standard of care for osteoarthritis (OA) pain therapy during the double-blind treatment phase as per investigator discretion.
16076344|NCT02336672|Device|Cryothermal ablation|Procedures are performed with patients sedated by anaesthesiologists. Device setting and application time are set and recorded on a computer, that analyzes the changes of the tissue's properties. The setting of the maximal application time is based on the results of our previously described ex-vivo and in-vivo studies and is adjusted to the tumour's size, thus ensuring a reduction of procedure-related complications. Application of Power Doppler makes the procedure safer. The HybridTherm probe is guided under real-time EUS into the tumour, and the success of its placement is an index of the treatment's feasibility. The system analyzes the effects on the tissue and EUS records the changes of the tissue, the growing edema around the treated area, and the tissue devitalization.
16076345|NCT02336659|Drug|exendin 9-39|Exendin 9-39 is a specific GLP-1 receptor antagonist
16076346|NCT02336659|Drug|sitagliptin|DPP-4 Inhibition
16076347|NCT02336659|Other|Placebo|Saline
16076348|NCT02336646|Drug|Allogenic MSC|Hypoxia-cultured human bone marrow derived mesenchymal stem cells
16076349|NCT02336646|Drug|Normal saline|
16076350|NCT02336633|Dietary Supplement|Resveratrol|2 capsules of 20mg in the morning and in the evening (4 capsules in total/day = 80mg/day) every day during 1 year
16076351|NCT02336633|Other|Placebo|
16076352|NCT02336620|Drug|Ringer acetate|Ringer acetate 10-20 ml/kg IV bolus in 15-30 min,repeat bolus as needed by patient status
16076353|NCT02336620|Drug|Normal saline|NSS 10-20 ml/kg IV bolus in 15-30 min,repeat bolus as needed by patient status
16076354|NCT02336607|Drug|Felodipine tablet (Plendil) alone|Felodipine sustained release tablet single drug therapy (1st week- 2nd week) Eligible subjects will first take felodipine tablet 5mg, once daily, orally for 2 weeks. If blood pressure is controlled after 2 weeks, then the subjects will continue the treatment until the end of primary therapy stage (14th week).
16076355|NCT02336607|Drug|Felodipine tablet (Plendil)+Hydrochlorothiazide|"Step 1: Eligible subjects will first take felodipine tablet 5mg, once daily, orally for 2 weeks.
~If blood pressure is not controlled after 2 weeks, then the subjects will go to Step 2: Felodipine sustained release tablet 5mg once daily combined with hydrochlorothiazide 12.5mg, once daily. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 3: The dosage of felodipine sustained release tablet will be escalated to 10mg, once daily, while the dosage of the combined drug remains the same. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 4: The dosage of felodipine sustained release tablet keeps 10mg, once daily, while the dosage of different combined drug is doubled."
16076356|NCT02336607|Drug|Felodipine tablet (Plendil)+Metoprolol tablet (Betaloc ZOK)|"Step 1: Eligible subjects will first take felodipine tablet 5mg, once daily, orally for 2 weeks.
~If blood pressure is not controlled after 2 weeks, then the subjects will go to Step 2: Felodipine sustained release tablet 5mg once daily combined with metoprolol succinate prolonged-release tablet (Betaloc ZOK) 47.5mg , once daily. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 3: The dosage of felodipine sustained release tablet will be escalated to 10mg, once daily, while the dosage of the combined drug remains the same. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 4: The dosage of felodipine sustained release tablet keeps 10mg, once daily, while the dosage of different combined drug is doubled."
16076357|NCT02336607|Drug|Felodipine tablets (Plendil)+Lisinopril (Zestril)|"Step 1: Eligible subjects will first take felodipine tablet 5mg, once daily, orally for 2 weeks.
~If blood pressure is not controlled after 2 weeks, then the subjects will go to Step 2: Felodipine sustained release tablet 5mg once daily combined with Lisinopril (Zestril) 10mg, once daily. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 3: The dosage of felodipine sustained release tablet will be escalated to 10mg, once daily, while the dosage of the combined drug remains the same. If blood pressure is not controlled after 4 weeks, then the subjects will go to Step 4: The dosage of felodipine sustained release tablet keeps 10mg, once daily, while the dosage of different combined drug is doubled."
16076358|NCT02336594|Drug|RDEA3170 10 mg|
16076359|NCT02336594|Drug|RDEA3170 2.5 mg|
16076360|NCT02336581|Behavioral|Acceptance and Commitment Therapy (ACT)|individual + group + follow-up phone contacts
16076361|NCT02336581|Behavioral|Enhanced Treatment as Usual (eTAU)|individual + group + follow-up phone contacts
16076362|NCT02336568|Drug|Oxytoine|In the first week 24 IU * 2/day. in the 2nd & 3rd 40 IU * 2/day
16076363|NCT02336568|Drug|PLACEBO|In the first week 24 IU * 2/day. in the 2nd & 3rd 40 IU * 2/day
16076364|NCT02336555|Drug|MK-8291|MK-8291 oral tablets
16076365|NCT02336555|Drug|Placebo|Placebo oral tablets
16076366|NCT02336542|Biological|5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm|TB subjects and non-TB subjects with lung disease inject 5μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm respectively. Two drug must use at the same person and different arm.
16076367|NCT02336542|Biological|5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm|TB subjects and non-TB subjects with lung disease inject 5μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm respectively. Two drug must use at the same person and different arm.
16076368|NCT02336542|Biological|10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm|TB subjects and non-TB subjects with lung disease inject 10μg/ml ESAT6-CFP10 in left arm and TB-PPD in right arm respectively. Two drug must use at the same person and different arm.
16076410|NCT02336191|Procedure|living donor liver transplantation|living donor liver transplantation
16076369|NCT02336542|Biological|10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm|TB subjects and non-TB subjects with lung disease inject 10μg/ml ESAT6-CFP10 in right arm and TB-PPD in left arm respectively. Two drug must use at the same person and different arm.
16076370|NCT02336529|Drug|Bupivacaine|
16076371|NCT02336529|Drug|NaCl|
16076372|NCT02336516|Drug|Azithromycin|ZITHROMAX ® 40mg/ml solution. DCI : Azithromycin . Pfizer ® 20mg/kg dose with a maximum dose of 500mg per day for three days
16076373|NCT02336516|Drug|Placebo (glucose solution 10%)|
16076374|NCT02336503|Drug|BBI-4000 Low Concentration|BBI-4000 Low Dose
16076375|NCT02336503|Drug|BBI-4000 Middle Concentration|BBI-4000 Middle Dose
16076376|NCT02336503|Drug|BBI-4000 High Concentration|BBI-4000 High Dose
16076377|NCT02336503|Drug|Placebo|Vehicle
16076378|NCT02336490|Other|Discharge Medication Delivery Service|hospital-owned outpatient pharmacy fills and delivers discharge medications to patients in their rooms prior to discharge
16076379|NCT02336477|Drug|Mexiletine|"Blisters of 10 capsules of 200 mg mexiletine hydrochloride.
~Patients will receive gradual dose of the treatment as it would be done in clinical practice.
~Mexiletine will be started at 200 mg / day (1 capsule to be taken at the beginning of the meal) and will be increased by 200mg every 3 days to reach a maximum of 600mg / day in 3 taken in 1 week.
~The duration of each treatment period is 18 days minimum (maximum 22 days)."
16076380|NCT02336477|Drug|placebo|
16076381|NCT02336451|Drug|Ceritinib|LDK378 is a gelatin capsule, administered orally once daily at a dose of 750 mg (five 150 mg capsules) on a continuous dosing schedule on an empty stomach.
16076382|NCT02336438|Dietary Supplement|glucomannan|Glucomannan is a natural, odorless soluble fiber that is found in the konjac plant. It will be given during the Intervention Phase in conjunction with the MMTT and then for 5 days at home with meals.
16076383|NCT02336425|Drug|QGE031|QGE031 120 mg per 1 mL liquid in vial
16076384|NCT02336425|Drug|Placebo|Placebo to QGE031 0 mg per 1 mL liquid in vial
16076385|NCT02336412|Other|SMS reminder|Daily SMS medication reminder
16076386|NCT02336386|Drug|CDD|Chemotherapy
16076387|NCT02336386|Drug|CDD Plus Bortezomib|Chemotherapy plus Proteasome Inhibitors
16076388|NCT02336373|Drug|hydroxyurea|Treat symptomatic HbSC patients to MTD on hydroxyurea, and assess for clinical improvement using the PedsQL™ Sickle Cell Disease Module version 3.0 after 6 months at MTD, compared to entrance scores
16076389|NCT02336360|Drug|Flortaucipir F18|No flortaucipir administered in this study. Subjects received flortaucipir in an Avid-sponsored study.
16076390|NCT02336347|Drug|AVP-786|
16076391|NCT02336347|Drug|AVP-923|
16076392|NCT02336334|Device|Positioning measurement|Logging of posturing informations
16076393|NCT02336334|Device|Patient feedback|Evaluation of patients questionary
16076394|NCT02336334|Procedure|Usefulness of a sketch|Helping the patients to understand posturing positions by randomized allocation of sketches
16076395|NCT02336334|Device|Closure rate of macular holes|closure rates of macular holes in the group with macular holes. Measurement using SD-OCT (spectral domain optical coherence tomography=
16076396|NCT02336321|Device|BNCI controlled hand exoskeleton|The BNCI system fuses and translates bio-signals related to user intention into control signals of an assistive device performing grasping motions
16076397|NCT02336308|Drug|Ketamine|
16076398|NCT02336308|Drug|Placebo, Normal Saline|
16076399|NCT02336295|Other|Food Frequency Questionnaires|filling a Food Frequency Questionnaires
16076400|NCT02336282|Device|transcranial Direct Current Stimulation (tDCS)|transcranial Direct Current Stimulation (tDCS) involves modulation of cerebral cortex excitability by the application of weak direct current to the scalp. tDCS is a technique that applies safe, low level direct current through large pads on the scalp to stimulate the underlying brain region, with current level < 0.10 C/cm2. Direct current is transferred by a pair of saline-soaked sponges from the anode to the cathode.
16076401|NCT02336282|Device|Sham|The sham intervention will be used in both arms with one arm receiving the sham intervention on day 1 and the other receiving the sham intervention on day 2. The sham procedure provides the same small current during ramp up to imitate the intervention, but the current is discontinued after ramp up and no intervention is provided. Direct current is transferred by a pair of saline-soaked sponges from the anode to the cathode.
16076402|NCT02336282|Other|Cognitive Assessment|"Three tests will be used to evaluate cognitive function: Dimensional Change Card Sort Test, Flanker Inhibitory Control and Attention Test, and List Sorting Working Memory Test. These measures have a computerized format and are nationally standardized.
~The Gray Oral Reading Test measures reading comprehension. Participants are asked to read a set of passages and recall specific details from the stories.
~The Woodcock Johnson Understanding Directions measures listening comprehension. Participants listen to a series of complex instructions, then follow the directions by pointing to various objects in a colored picture."
16076403|NCT02336282|Other|Brain Games Stimulation|Cognitive exercises using the Lumosity Brain Games program will be used simultaneously with the tDCS intervention. Participants will be asked to engage in training for 20 minutes a day, two days per week over 5 weeks. This program involves cognitive exercises designed to enhance executive function and processing speed.
16076404|NCT02336256|Procedure|Procedures of hernia repair.|We use two procedure: single incision laparoscopic surgery (SILS) and totally extra-peritoneal repair (TEP). SILS procedure used one approche - 10mm (experimental). TEP procedure used three approaches 2x5mm and 1x10mm (active comparator).
16076405|NCT02336243|Dietary Supplement|Docosahexaenoic acid (DHA)|Docosahexaenoic acid (DHA), 600 mg per day. Each woman will take three DHA capsules per day (200 mg each), as early in gestation as possible and until the end of pregnancy.
16076406|NCT02336243|Dietary Supplement|Placebo (for Docosahexaenoic acid (DHA))|Each women allocated to the placebo group, will receive three placebo capsules per day. The placebo capsules will have same size, aspect and flavor than the DHA capsules.
16076407|NCT02336230|Drug|remestemcel-L|Subjects will be treated with intravenous (IV) remestemcel-L at a dose of 2 x 10e6 MSC/kg (actual body weight at screening) twice per week for each of 4 consecutive weeks. Infusions will be administered at least 3 days apart and no more than 5 days apart for any infusion.
16076408|NCT02336217|Other|Experimental Group instructions for glucose management via App|The Experimental Group receives individually calculated instructions for glucose management management via the App.
16076411|NCT02336178|Drug|Benefix|"Subjects will be treated by the investigator according to usual care in China and in accord with the China BeneFIX Package Insert.
~The treatment duration is approximately 6 months (±7 days) or approximately 50 Exposure Days (EDs) (±5 EDs) (see protocol definition on EDs) whichever occurs first."
16076412|NCT02336165|Drug|Durvalumab|Durvalumab is administered as an IV infusion over 60 ± 5 minutes Q2W.
16076413|NCT02336165|Radiation|Standard radiotherapy|Focal radiotherapy is administered at 2 Gy given daily 5 days per week for a total of 60 Gy over 30 fractions per local institutional guidelines or local prescribing information. On days when radiotherapy and durvalumab overlap, radiotherapy is administered first followed by durvalumab.
16076414|NCT02336165|Biological|Bevacizumab|Bevacizumab is administered as an IV infusion (per local prescribing information) Q2W. When durvalumab and bevacizumab are administered together (i.e., Cohorts B2, B3, and C), durvalumab is administered first followed by a 1-hour observation period, after which, bevacizumab is infused.
16076415|NCT02336152|Device|Anaesthesia, Teles Pro, Body suit|
16076416|NCT02336139|Drug|Sofosbuvir (SOF)/GS-5816|12 weeks of Sofosbuvir (SOF)/GS-5816 (400mg/100mg) in an oral once-daily fixed dose
16076417|NCT02336126|Behavioral|Biopsychological intervention|
16076418|NCT02336113|Behavioral|multidisciplinary treatment|The pharmacist will conduct medication reconciliation at admission, perform medication reviews during the hospital stay and provide drug information (written and oral) to the patient before discharge, as well as written drug information to the next level of care
16076419|NCT02336100|Device|Endoscopy (FICE and pCLE)|FICE is Flexible Spectral Imaging Color Enhancement and pCLE is probe-based Confocal Lase Endomicroscopy
16076420|NCT02336087|Drug|Gemcitabine Hydrochloride|Given IV
16076421|NCT02336087|Drug|Paclitaxel Albumin-Stabilized Nanoparticle Formulation|Given IV
16076422|NCT02336087|Drug|Metformin Hydrochloride|Given PO
16076423|NCT02336087|Dietary Supplement|Therapeutic Dietary Intervention|Given PO
16076424|NCT02336087|Other|Laboratory Biomarker Analysis|Correlative studies
16076425|NCT02336087|Other|Quality-of-Life Assessment|Ancillary studies
16076426|NCT02336074|Drug|Combination Antiretroviral Therapy (cART)|Likely consisting of an Nucleoside reverse-transcriptase inhibitor (NRTI) backbone i.e. Truvada plus a ritonavir-boosted protease inhibitor (PI) e.g. Darunavir + ritonavir. Prescribed at week 0 for the duration of the study.
16076427|NCT02336074|Drug|Raltegravir|All participants will be dispensed sufficient supplies of Raltegravir to ensure they have sufficient medication to last to the next study visit. Raltegravir is supplied in marketed pack with 30 tablets per bottle.
16076428|NCT02336074|Drug|Vorinostat|"Vorinostat (suberoylanilide hydroxamic acid abbreviated to SAHA) inhibits the histone deacetylases HDAC1, HDAC2, HDAC3 (Class I) and HDAC6 (Class II).
~Vorinostat is supplied as capsules containing 100mg vorinostat and the following inactive ingredients: microcrystalline cellulose, sodium croscarmellose and magnesium stearate."
16076429|NCT02336074|Biological|ChAdV63.HIVconsv (ChAd)|Dosage: 5x1010vp .This dose is obtained by injecting 0.37ml of the vaccine at 1.35x1011vp/ml without dilution. This prime vaccination is administered intramuscularly (IM) into the deltoid muscle of the non-dominant arm at post-randomisation week 00.
16076430|NCT02336074|Biological|MVA.HIVconsv (MVA)|Dosage: 2x108pfu Administration: This dose is obtained by injecting 0.23 ml of the vaccine IM at 8.6x108pfu/ml without dilution. This boost vaccination is administered intramuscularly (IM) into the deltoid muscle of the non-dominant arm at post-randomisation week 08 Day 1 (2 prior to start of vorinostat)
16076431|NCT02336061|Behavioral|Evaluation of gender differences on the psychosocial and economic impact.|
16076432|NCT02336048|Drug|Chlorambucil|Chlorambucil at a dose of 0.5 milligrams per kilogram (mg/kg) will be administered orally per local prescribing information, on Days 1 and 15 of Cycles 1 to 6.
16076433|NCT02336048|Drug|Obinutuzumab|Obinutuzumab at a dose of 100 milligrams (mg) as an intravenous (IV) infusion will be administered on Cycle 1 Day 1; 900 mg as IV infusion on Cycle 1 Day 2; 1000 mg as IV infusion on Cycle 1 Days 8 and 15; and 1000 mg as IV infusion on Day 1 of each subsequent cycle for up to 6 cycles.
16076434|NCT02336048|Drug|Placebo|Placebo matching to tocilizumab will be administered as IV infusion on Cycle 1 Day 1 (prior to the first dose of obinutuzumab).
16076435|NCT02336048|Other|Standard Premedication|Standard-of-care premedication consisting of antipyretic, antihistamine, and corticosteroid will be administered as per United States Package Insert/ Summary of Product Characteristics on Cycle 1 Days 1 and 2 (prior to the first and second dose of obinutuzumab, respectively).
16076436|NCT02336048|Drug|Tocilizumab|Tocilizumab at a dose of 8 mg/kg or adjusted dose (up to a maximum threshold of 20 mg/kg) will be administered as IV infusion on Cycle 1 Day 1 (prior to the first dose of obinutuzumab).
16076437|NCT02336035|Procedure|Volar plate|Flexor carpi radialis (FCR)-approach. Standard surgical procedure with a volar locking plate
16076438|NCT02336022|Device|Respiratory Motion Inc|
16076439|NCT02336009|Device|total wrist arthroplasty, Trimed|A new total wrist arthroplasty design. A pilot study.
16076440|NCT02335996|Biological|Blood samples for measuring adiponectin, leptin and omentin plasma|
16076441|NCT02335996|Device|MRI at 3 Tesla|Evaluation by MRI at 3 Tesla of the amount of ectopic fat heart, liver and pancréas and bone marrow.
16076442|NCT02335983|Drug|Carfilzomib|Administered once weekly by 30-minute intravenous (IV) infusion on days 1, 8, and 15 of each 28-day cycle.
16076443|NCT02335983|Drug|Lenalidomide|Administered orally once daily on days 1-21 of each 28-day cycle.
16076444|NCT02335983|Drug|Dexamethasone|Administered by mouth or IV at 40 mg on days 1, 8, and 15 of each 28-day cycle and on day 22 of cycles 1 to 8.
16076445|NCT02335970|Other|Training group|"After 1 week
~Chest expansions
~Static thoracic extension in prone
~Lateral flexion of the spine in standing
~Bilateral shoulder flexion
~Shoulder external rotation of shoulders
~Rotation of the thoracic spine in sitting
~Static back extensor strength in prone
~After 1 month
~Thoracic extension, rotation and flexion abduction
~Hand in neck and in back
~Bilateral active flexion abduction
~Strength training of leg muscles
~Static back extensor strength
~After 2 months
~Strength training of legs and back muscles
~Push-ups against a wall
~Thoracic extension in sitting and standing
~Thoracic rotation in lying
~Stretching of mm. pectoralis Training was performed daily with 10 rep of each exercise"
16076480|NCT02335593|Drug|Iron Hydroxide Saccharate Complex Solution for injection|Iron Hydroxide Saccharate Complex Solution for injection
16076446|NCT02335957|Radiation|Irradiation|Intentional versus incidental irradiation of lymphatic node areas, administered using a lineal accelerator, after 3D delimitation of the supraclavicular and axillary levels I, II and III. In both treatment arms, further tumoral bed boost will be allowed according to the investigator criteria, whether dose contribution to the nodal areas can be calculated. Due to its nature, interventions cannot be asked.
16076447|NCT02335944|Drug|INC280|cMET inhibitor
16076448|NCT02335944|Drug|EGF816|EGFR-TKI
16076449|NCT02335918|Drug|Combination of varlilumab and nivolumab|"Phase I: Varlilumab dosing will be dependent on the cohort assigned in combination with 3 mg/kg of nivolumab every two weeks.
~Phase II: Patients with CRC, RCC or GBM enrolled in Phase ll will receive 3.0 mg/kg of varlilumab in combination with 240 mg of nivolumab every 2 weeks. Patients with SCCHN or ovarian cancer will receive varlilumab at a dose of either 3 mg/kg every 2 weeks, 3 mg/kg every 12 weeks, or 0.3 mg/kg every 4 weeks, in combination with 240 mg of nivolumab every 2 weeks.
~Patients may be discontinued from receiving study treatment based on the results of disease assessments or if experiencing intolerable side effects."
16076450|NCT02335905|Drug|Ceftaroline Fosamil|IV Ceftaroline fosamil 15 mg/kg (or 600 mg if > 40 kg) infused over 120 (± 10) minutes q8h (± 1 hour) for children 2 years of age - 17 years of age (inclusive). IV Ceftarloine Fosamil 10 mg/kg infused 120 (± 10) minutes q8h (± 1 hour) for children 1 years of age - less than 2 years of age (inclusive).
16076451|NCT02335879|Biological|Gonal-F|
16076452|NCT02335866|Procedure|test groups|At the test sites, the previously prepared PRF was positioned over the recession defects, the coronal margin of the PRF was placed at the CEJ
16076453|NCT02335866|Procedure|Control groups|Split-full-split thickness flap incisions were performed in a coronal-apical direction. The papillae adjacent to the involved tooth were de-epithelialized to create a connective tissue bed. The gingival flap was repositioned without tension, with its margin located on the enamel, on the test and control sides. It was held in that position with 5-0 resoble sutures
16076454|NCT02335840|Other|CAF-1|In this intervention the volunteers ingested one dose of caffeinated coffee containing 144 mg of caffeine
16076455|NCT02335840|Other|CAF-2|In this intervention the volunteers ingested two doses of caffeinated coffee containing 288 mg of caffeine
16076456|NCT02335840|Other|CAF-3|In this intervention the volunteers ingested three doses of caffeinated coffee containing 432mg of caffeine
16076457|NCT02335840|Other|DESC|In this intervention the volunteers ingested one dose of decaffeinated coffee containing 108 mg of caffeine
16076458|NCT02335827|Procedure|irreversible electroporation|Percutaneous (CT-guided and/or US-guided) or open IRE with voltage in level B for renal tumors
16076459|NCT02335814|Drug|FLX925|
16076460|NCT02335788|Device|The EMBA Peripheral Embolization Device|arterial and venous embolization in the peripheral vasculature
16076461|NCT02335749|Device|The ZELTIQ System|The CoolSculpting machine will be used to perform the treatments.
16076462|NCT02335736|Drug|Gonadotropins releasing hormone antagonist|
16076463|NCT02335723|Device|Alteco LPS Adsorber|"Alteco® LPS Adsorber is a Class IIa medical device developed in accordance with existing international standards. Alteco® LPS Adsorber does not contain any pharmaceutical or toxic components.
~Alteco® LPS Adsorber is used for the adsorption of LPS as endotoxins. The capturing component is a specially designed synthetic peptide developed for adsorption of endotoxin. The capturing component has high affinity to Lipid A, i.e. a constant component in the endotoxin molecule, which ensures efficient reduction of endotoxins from different bacterial species."
16076464|NCT02335723|Device|Placebo|Exactly the same as Alteco LPS Adsorber but no peptide component has been attached to the matrix (i.e. there is no adsorber functionality)
16076465|NCT02335710|Device|Journey II BCS TKA|
16076466|NCT02335697|Behavioral|Attitude change towards female circumcision|The intervention comprises of a series of meetings between newly arrived Somalis and established Somalis. At each meeting, a pre-determined topic relating to FC will be discussed. The topics include culture, religion, health, children's rights, and Swedish laws. Different experts, chosen to match the specific topic of the meeting will be invited to each meeting to facilitate the interactive discussions between the participants. Somalis who are both familiar with the Swedish and Somali culture will facilitate the meetings. The intervention spans over a time period of six months. The intervention meetings will be held during the first five months of the intervention period; one meeting scheduled per month. Thereafter, there will be a 'wash-out' period of one month to allow for reflections and to minimize the risk of courtesy bias.
16076467|NCT02335697|Other|No intervention|
16076468|NCT02335684|Other|CF-LVAD pump speed baseline.|Submaximal exercise test with baseline pump speed.
16076469|NCT02335684|Other|CF-LVAD pump speed increased.|Submaximal exercise test with increased pump speed (+800RPM).
16076470|NCT02335671|Procedure|Intra-operative Magnetic Resonance Imaging (MRI)|
16076471|NCT02335671|Other|Mass Spectrometer Analysis of Tissue Sample|Analysis of Tissue Sample
16076472|NCT02335658|Drug|DSP-5423P|40-80mg/day
16076473|NCT02335645|Other|Body Weight Supported Treadmill Use of Patients with ACL Reconstruction|"Standard ACL protocol will be followed throughout the treatment of each patient. The only variance from treatment will be using body weight supported treadmill and video gait analysis to help guide treatment.
~The first analysis will be performed at week 6 after surgery. Motion capture sensors will be placed on the patient at different anatomical positions. The patient will then run in a body weight supported treadmill. During this run, video capture will be performed and later analyzed to determine biomechanical kinematics.
~Based on findings of video gait analysis, exercise progression will be altered to improve deficits found. This process will be repeated at week 8 of rehabilitation in the body weight supported treadmill.
~At week 10 and 12, the patient will shift treatment from the body weight supported treadmill, to a standard treadmill. The process will be repeated using the same anatomical landmarks and video capture."
16076474|NCT02335632|Drug|Probiotics (Lacidofil®)|7 days of cultured Lactobacillus rhamnosus R0011/acidophilus R0052 (120 mg/day)
16076475|NCT02335632|Drug|Placebo|For probiotics
16076476|NCT02335619|Behavioral|Early palliative care|
16076477|NCT02335593|Dietary Supplement|Zinc Sulphate|Zinc Sulphate Hard Gel capsules 110mg
16076478|NCT02335593|Other|Corn Starch filled Hard Gel Capsules|Corn Starch filled Hard Gel Capsules
16076479|NCT02335593|Drug|Epoetin alfa 2000-4000 IU solution for injection|Epoetin alfa 2000-4000 IU solution for injection
16077133|NCT02330926|Other|nutritional supplements and advice|
16076481|NCT02335580|Drug|Somatostatin and its analogs|Somatostatin and/or octreotide will be intravenously infused.
16076482|NCT02335580|Procedure|Endoscopic sclerotherapy, endoscopic variceal ligation, endoscopic tissue glue injection|Endoscopic sclerotherapy, endoscopic variceal ligation, and/or endoscopic tissue glue injection will be performed based on the endoscopists' choice.
16076483|NCT02335567|Other|there is no intervention|
16076484|NCT02335554|Behavioral|MoodHacker|Mobile-web app to educate users about depression and promote daily mood and positive activity monitoring.
16076485|NCT02335554|Behavioral|Alternative Care|Online information about depression from government and other trusted sources to educate users about depression.
16076486|NCT02335528|Behavioral|SimCoach|
16076487|NCT02335515|Device|Soctec|Gastroretentive Drug Delivery System
16076488|NCT02335502|Device|Implantation with the commercially available Axium neurostimulator|
16076489|NCT02335489|Device|Implantation with the commercially available Axium neurostimulator|
16076490|NCT02335450|Behavioral|Motivational Interviewing|The participant will describe their unique physical activity challenges and their physical activity goals with the physical therapist. Using the technique of motivational interviewing, the physical therapist will work with the participant to help identify potential solutions to challenges and set realistic activity goals for the next week. Each week, the participant and the physical therapist will review the previous week's activity data, and the participant's reports of any challenges or problems they encountered in meeting their physical activity goals the previous week. The participant will identify new activity goals for the next week.
16076491|NCT02335450|Device|Wristband physical activity monitor|The participant will wear a Fitbit wristband which will track the participant's daily steps and minutes of physical activity.
16076492|NCT02335424|Biological|pembrolizumab|IV infusion
16076493|NCT02335411|Biological|pembrolizumab|IV infusion
16076494|NCT02335411|Drug|cisplatin|IV infusion
16076495|NCT02335411|Drug|5-FU|IV infusion
16076496|NCT02335411|Drug|capecitabine|oral tablets
16076497|NCT02335398|Drug|Methadone|The starting methadone dose for naïve-opioid patients was 2.5-5 mg every 8-12 hours. In patients who required opioid rotation, the conversion ratios, morphine:methadone, were 4:1, 8:1, and 12:1 for patients receiving less than 90 mg of morphine, receiving 90-300 mg of morphine, and receiving more than 300 mg of morphine , respectively. A fixed dose ratio of 1:20 was applied for changing from transdermal fentanyl to oral methadone. Then, the daily calculated methadone dose was divided into 8-12 hourly dosing. Calculated rescue dose was estimated to be 10-15% of total daily dose of methadone which there was switched to be morphine syrup in the ratio of 1:4.
16076498|NCT02335385|Procedure|single incision laparoscopic varicocelectomy|bilateral and unilateral varicocelectomy was performed through a single transumbilical flexible SILS port.
16076499|NCT02335385|Procedure|conventional transperitoneal laparoscopic varicocelectomy|bilateral and unilateral varicocelectomy was performed through a conventional 3-ports transperitoneal varicoceletomy
16076500|NCT02335372|Procedure|Wide-Field White Light Imaging|Initial wide-field white light images acquired of cervix in unpolarized and cross-polarized modes during cervical colposcopy.
16076501|NCT02335372|Drug|Acetic Acid|3-6% acetic acid applied to cervix after wide-field while light imaging during colposcopy.
16076502|NCT02335372|Drug|Proflavine Solution|Topical application of 0.01% proflavine solution applied for 1 minute to cervix after sites for biopsy have been identified during colposcopy.
16076503|NCT02335372|Procedure|Wide-Field Fluorescence Imaging|Wide-field imaging in fluorescence mode performed during cervical colposcopy after topical proflavine solution applied.
16076504|NCT02335359|Drug|tranexamic acid diluted in 100 ml of saline solution (loading dose)|
16076505|NCT02335359|Drug|tranexamic acid undiluted (continous infusion)|
16076506|NCT02335359|Drug|Placebo|Saline
16076507|NCT02335346|Drug|Duloxetine|Administered orally
16076508|NCT02335333|Other|No treatment|
16076509|NCT02335307|Genetic|CYP2D6 genotyping|CYP2D6 genotype results and an interpretive report will be placed in the electronic medical record to assist the physician with prescribing medication for pain management.
16076510|NCT02335307|Other|Pain assessment questionnaire|A pain assessment questionnaire will be administered at baseline and 3 months.
16076511|NCT02335307|Other|Physician assessment|20-item survey administered to physicians treating patients enrolled in the study
16076512|NCT02335294|Drug|TRV130|Rescue: Ibuprofen, oxycodone
16076513|NCT02335294|Drug|Morphine|Rescue: Ibuprofen, oxycodone
16076514|NCT02335294|Drug|Placebo|Rescue: Ibuprofen, oxycodone
16076515|NCT02335281|Procedure|FMT|Standardized FMT once
16076516|NCT02335281|Drug|Mesalazine|2g Po perday
16076517|NCT02335268|Drug|N-Plate / romiplostim|medical intervention in 3 patient groups (MDS patients with IPSS Low/Int-1) that are stratified according to their baseline TPO-Level and previous transfusions
16076518|NCT02335255|Drug|Naftifine Hydrochloride Gel 2%|Naftifine Hydrochloride Gel 2% applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.
16076519|NCT02335255|Drug|Naftin® Gel 2%|Naftin® Gel 2% applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.
16076520|NCT02335255|Drug|Placebo Topical Gel|Placebo Topical Gel applied once daily for fourteen consecutive days to affected areas plus a 1/2 inch margin of healthy surrounding skin.
16076521|NCT02335242|Drug|Sildenafil 20 mg tablets|
16076522|NCT02335242|Other|Placebo tablets (resembling Revatio)|
16076523|NCT02335229|Device|Axium DRG Neurostimulator|Implantation with Axium DRG Neurostimulator
16076524|NCT02335216|Device|Implantation with the commercially available Axium neurostimulator|
16076525|NCT02335203|Drug|Depot medroxyprogesterone acetate|One injection intragluteally of 400mg depot medroxyprogesterone acetate at the time of the patient's first visit with the Program in Womens' Oncology
16076526|NCT02335203|Other|Placebo|One injection intragluteally of 1mL Normal Saline (0.9% Sodium Chloride) at the time of the patient's first visit with the Program in Womens' Oncology
16076700|NCT02333929|Device|STA- Rivaroxaban Calibrator&Control|One sample blood collected per patient the day of the treatment (drawn soon after the the drug intake)
16076701|NCT02333916|Other|overfeeding + exercise pre-training|
16076527|NCT02335190|Procedure|Radiofrequency ablation|RF ablation will be performed using 2 Nimbus multitined electrodes in a bipolar configuration. The electrodes will be placed along the lateral crest using a leap-frogging technique from the inferomedial aspect of the PSIS to the third transverse sacral tubercle at 1.5-2 cm intervals at the skin surface. A radiofrequency current will be passed for 120 seconds per site resulting in thermal coagulation of the plexus. Prior to performing the thermal lesion, electrical stimulation at 2 Hz and 2.0 V will be administered.
16076528|NCT02335190|Procedure|Sensory block|Participants will undergo a lidocaine block of the PSN at the lateral crest under ultrasound guidance. 0.5 mL of 2% lidocaine will be injected from the inferomedial border of the PSIS to the third transverse sacral tubercle at approximately 1.5 cm intervals along the skin surface.
16076529|NCT02335190|Drug|Lidocaine|
16076530|NCT02335177|Behavioral|Interventional arm|At home patients have both technologies for autonomy (walkers, treadmill) and tailored physical activity program performed with the help of the home carer. Intervention takes 3 months. Assessment at hospital discharge et at 3 months.
16076531|NCT02335164|Biological|recombinant influenza hemagglutinin|recombinant influenza hemagglutinin
16076532|NCT02335164|Biological|Advax1|Delta inulin adjuvant formulation 1
16076533|NCT02335164|Biological|Advax2|Delta inulin adjuvant formulation 2
16076534|NCT02335151|Drug|Desflurane|Apply desflurane as anesthetic
16076535|NCT02335138|Behavioral|Couples HIV Testing and Counseling (CHTC, CVCT)|Male couples randomized to the experimental group (Couples HIV Testing and Counseling, CHTC/CVCT) will receive HIV counseling and testing as a couple via an online, HIPPA-compliant videoconferencing service. The dyad-centered session will last less than one hour and focus on couples agreement, prevention strategies, and/or linkage to HIV care, depending on each couple's test results. Participants will complete follow-up surveys at 3 and 6 months post-testing.
16076536|NCT02335138|Behavioral|at-home test kit|Male couples in the control group will receive test kits, but will not receive any testing intervention. Once individual results are reported,participants will be contacted via phone by study staff with options for referrals to services for the reactive partner(s). Participants will complete follow-up surveys at 3 and 6 months post-testing.
16076537|NCT02335125|Behavioral|Motivational Interviewing|
16076538|NCT02335125|Behavioral|Cognitive Behavioral Therapy Elements|
16076539|NCT02335125|Drug|Psychotropic Drugs|
16076540|NCT02335125|Other|Care Management|
16076541|NCT02335112|Procedure|Irreversible electroporation (IRE)|Irreversible Electroportion For Unresectable Head and Neck Neoplasms guide with ultrasound or/and CT.
16076542|NCT02335112|Device|NanoKnife|
16076543|NCT02335099|Drug|ticagrelor|ticagrelor 90 mg twice a day for 6 months
16076544|NCT02335099|Drug|Placebo|1 pill twice a day for 6 months
16076545|NCT02335073|Other|Venous blood|
16076546|NCT02335060|Drug|Delta-9-THC|Active Delta-9-THC (0.036mg/Kg) given intravenously.
16076547|NCT02335060|Drug|N-acetylcysteine|A pill given orally.
16076548|NCT02335060|Drug|Placebo|Placebo (about a quarter spoon of alcohol with no THC) given intravenously.
16076549|NCT02335060|Drug|Placebo|"Placebo sugar pill given orally with no N-acetylcysteine."
16076550|NCT02335047|Other|Impaired passivity test|Description of the test: the subject lies in the supine position on an exercise mat with his/her feet together. The subject is told to let his/her arms rest loosely by his/her side (as if they were ropes) and to keep the head aligned with the back. The examiner pulls the subject into the sitting position by pulling on the subject's wrists, with passive flexion of the trunk until the hip joint is fully flexed..
16076551|NCT02335034|Behavioral|Study Group Educational courses, DVD, print material of lectures|2 Educational courses (two months apart). Receive DVD and printed material of the lectures.
16076552|NCT02335034|Behavioral|Control Group only make evaluations / consultations with all professional teams|"Evaluations and consultations with all professional teams without classes for 2 years.
~At two years: two days of lectures two months apart with DVD and printed material of the lectures. Will be followed by two more years."
16076553|NCT02335021|Dietary Supplement|Sucralose|2 packets per 12 fl oz
16076554|NCT02335021|Dietary Supplement|Sucrose|equisweet to sucralose
16076555|NCT02335021|Dietary Supplement|Sucralose + maltodextrin|sucralose plus equicaloric (to sucrose) maltodextrin
16076556|NCT02335021|Dietary Supplement|Sucralose + Sucrose|half the amount of sucralose plus equicaloric sucrose
16076557|NCT02335008|Dietary Supplement|Sucralose|2 packets per 12 fl oz
16076558|NCT02335008|Dietary Supplement|Sucrose|equisweet to sucralose
16076559|NCT02334982|Drug|TAK-137|TAK-137 tablets
16076560|NCT02334982|Drug|Placebo|TAK-137 placebo-matching tablets
16076561|NCT02334969|Drug|Naoxintong Capsule|This is Naoxintong capsule,which is composed of Huangqi,Chishao,Danshen,Danggui, Chuanxiong,Taoren,Honghua,Ruxiang,Moyao,Jixueteng,Niuxi,Guizhi,Sangzhi,Dilong,Quanxie,etal.
16076562|NCT02334969|Drug|Placebo|placebo capsule has the same as Naoxintong capsule in the appearance, shape,colour and content tinct.
16076563|NCT02334956|Other|Brain MRI|
16076564|NCT02334943|Biological|Blood test|Blood test
16076565|NCT02334930|Other|Biopsy|
16076566|NCT02334917|Procedure|Surgical wound closure with superficial absorbable sutures|Different superficial absorbable sutures will be used in the closure of skin wounds after Mohs surgery. No drugs or devices are being compared, only the two different absorbable sutures (Vicryl Rapide and Fast Absorbing Gut).
16076567|NCT02334904|Drug|Aripiprazole|To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study)
16076568|NCT02334904|Drug|Risperidone|To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study).
16076569|NCT02334891|Other|Standard|Standard management
16076570|NCT02334878|Biological|Stem Cells,Mesenchymal|The patient will be placed in lithotomy position. A Foley's catheter (size 18) will be inserted in the urethra, then under local anaesthesia; retrieved cells (total 20- 30 million cells per patient in 10cc syringe) will be injected into the submucosal tissue at the level of the proximal urethra just distal to the bladder neck (guided by stretch on the Foley's catheter), at 3,9,12 o'clock, injecting around 3.5 cc in each site.
16076702|NCT02333916|Behavioral|fitness training|
16076703|NCT02333916|Other|overfeeding + exercise post-training|
16076571|NCT02334878|Procedure|surgery (TVT)|A small midurethral incision will be made in the vaginal mucosa, then a polypropylene 40*1cm mesh tape attached to two curved trocars will be passed lateral to the urethra & through the endopelvic fascia into the retropubic space. The trocar will then be passed along the back of the pubic bone, through the rectus fascia, in two small suprapubic skin incisions, then the tension on the tape adjusted & the remaining tape cut off at the level of the skin.
16076572|NCT02334865|Biological|Incomplete Freund's Adjuvant|Given SC
16076573|NCT02334865|Other|Laboratory Biomarker Analysis|Correlative studies
16076574|NCT02334865|Drug|Lenalidomide|Given PO
16076575|NCT02334865|Biological|Sargramostim|Given SC
16076576|NCT02334865|Biological|SVN53-67/M57-KLH Peptide Vaccine|Given SC
16076577|NCT02334839|Other|Observational only|Endothelial function will be assessed using ENDO-PAT (Itamar medical LTD, Caesarea, Israel) device, which evaluates the change in peripheral vascular tone in reaction to temporal ischemia in a process called Reactive Hyperemia (RH) .The RH-PAT is a blood pressure measurement-like cuff which is placed on the non-dominant arm. A pneumatic probe is placed on the index finger bilaterally (one serves as a control). After a baseline assessment for a 5 minutes period, the cuff is inflated to a 60mm Hg pressure above the systolic pressure in order to occlude the arterial flow distal to the brachial artery. After 5 minutes of occlusion, a prompt deflation of the cuff results in a RH response and vasodilatation in the distal arteries including those monitored in the index finger. The sensor translates the change in vascular tone and the ENDO-PAT V3.0.4 device analyzes the data automatically. The results are given in a RH index scale that reflects the level of reactive hyperemia.
16076578|NCT02334826|Procedure|PCI -BVS|All patients in the PCI arm will be treated with bioresorbable scaffolds (Absorb). Lesions in native coronary arteries ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate) will be treated after confirmation of functional significance with iFR/FFR.
16076579|NCT02334826|Procedure|CABG|In the CABG arm the surgery will be carried out according to the routine practice, with the intention of complete revascularization and frequent use of arterial grafts.
16076580|NCT02334813|Drug|Prednisone|Continuous daily therapy
16076581|NCT02334813|Drug|Dexamethasone|4-day pulses every 3 weeks
16076582|NCT02334800|Drug|Palbociclib 75 mg Capsule|Single oral 75 mg dose of palbociclib followed by serial PK sampling up to 192 hours post-dose (up to 120 hours post-dose for the healthy volunteer cohort).
16076583|NCT02334787|Drug|0.3% OPA-15406 Ointment|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 0.3 % OPA-15406 ointment assessed until 48 hours postdose. In the multiple administration period, same subjects were treated with assigned 0.3% OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
16076584|NCT02334787|Drug|1% OPA-15406 Ointment|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 1 % OPA-15406 ointment assessed until 48 hours postdose. In the multiple administration period, same subjects were treated with assigned 1% OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose
16076585|NCT02334787|Drug|3% OPA-15406 Ointment|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration period, subjects were treated with assigned 3 % OPA-15406 ointment assessed until 48 hours postdose. In the multiple administration period, same subjects were treated with assigned 3% OPA-15406 ointment twice daily for 14 days and assessed until 48 hours post dose.
16076586|NCT02334787|Drug|Placebo Ointment|32 subjects were randomly allocated to 4 treatment groups (8 subjects per dose). In a single administration periodriod, subjects were treated with assigned placebo ointment assessed until 48 hours postdose. In the multiple administration period, same subjects were treated with assigned placebo ointment twice daily for 14 days and assessed until 48 hours post dose.
16076587|NCT02334774|Procedure|Swallowing and Oral Care Program|An Swallowing and Oral Care Program involves moisturizing and cleansing oral cavity, massaging salivary gland, oral motor exercise daily, and intake education as needed.
16076588|NCT02334748|Drug|canakinumab|canakinumab
16076589|NCT02334735|Biological|DC Vaccine|"DCs pulsed with 100µg/mL peptide (NY-ESO-1 and Melan-A/MART-1)
~10 to 15 x 106 DCs per peptide antigen (NY-ESO-1 and Melan-A/MART-1) (total not to exceed 50 x 10^6 cells)"
16076590|NCT02334735|Biological|Montanide Vaccine|250 µg peptide (NY-ESO-1 and Melan-A/MART-1) and 1.1 mL Montanide ISA-51 VG
16076591|NCT02334735|Biological|Poly-ICLC|1.4 mg
16076592|NCT02334722|Drug|Levetiracetam|
16076593|NCT02334709|Radiation|Stereotactic body radiotherapy|A first line TKI will be administered according to the standard dosing of the drug for metastatic RCC during a 1-week run-in period after which SBRT will be delivered to the largest metastatic lesion concurrently with the TKI. The SBRT dose will be escalated in 3 dose levels, starting at 24Gy (8 Gy per fraction), followed by 30 Gy (10 Gy per fraction) and 36 Gy (12 Gy per fraction).
16076594|NCT02334683|Device|Electrical stimulation|The purpose of this study is to investigate the use of two ways of locating the muscle for botulinum toxin (BoNT) injection for the treatment of focal hand dystonia and upper limb spasticity located by either electrical stimulation using a needle or ultrasound using sound waves.
16076595|NCT02334683|Device|Ultrasound|The purpose of this study is to compare how the muscle is located by either electrical stimulation using a needle or ultrasound using sound waves.
16076596|NCT02334670|Drug|Fluconazole|HIV-infected patients with CD4 ≤100 cells/μL who present for HIV care at outpatient clinics (OPCs) in Vietnam where CrAg screening is offered will be recruited into the study. Study participants will be screened for cryptococcal antigen using the Lateral Flow Assay (LFA). Those who are CrAg-positive, but have no features of central nervous system (CNS) disease, will be treated with high-dose fluconazole.
16076597|NCT02334657|Other|SF-36|postal questionnaire consisting a short-form health survey with 36 simple questions (SF-36)
16076598|NCT02334644|Dietary Supplement|Probiotic Formula (Lactobacillus helveticus R0052 and Bifidobacterium longum R0175)|2 sachets/day x 12 weeks
16076599|NCT02334644|Dietary Supplement|Placebo|2 sachets/day x 12 weeks
16076600|NCT02334631|Drug|High Volume Simethicone|High volume simethicone is defined as 1125 mg simethicone in 750 ml of water (1.5 mg/ml).
16076601|NCT02334631|Drug|Standard Volume Simethicone|Standard volume simethicone is defined as 300 mg simethicone in 200 ml of water (1.5 mg/ml).
16076827|NCT02333162|Drug|Mycophenolate Mofetil|Given IV or PO
16076602|NCT02334605|Other|cold dry air|"Patients will be asked to acclimatize to room temperature for 20 minutes prior to exposure to cold dry air.
~Through a nasal cannula, compressed dry air for medical use will be delivered for 15 minutes (25L/minute). Patients will be instructed to breathe through the nose only. The temperature of the air reaching the nose will be approximately -10°C and the relative humidity less than 10-15%."
16076603|NCT02334605|Device|hyperosmolar discs|A small paper disc (5-6mm of diameter) previously loaded with 50µl NaCl 5,13M will be applied on the right nasal septum for 1 minute and then be discarded.
16076604|NCT02334605|Device|capsaicin nasal spray|1 puff of a nasal spray with a solution of capsaicin 0,0001mM will be sprayed in each nostril of the subject and subjects will be asked to score visual analogue scale for irritation of the nasal mucosa immediately after the adminitration.
16076605|NCT02334592|Radiation|Sunbed tanning|Invention groups undergo a 12-week tanning protocol that follows Health Canada's RED Act
16076606|NCT02334579|Radiation|CyberKnife Stereotactic Radiosurgery|Five treatments given over about one week.
16076607|NCT02334566|Behavioral|NET TX|Intervention procedures are a behavioral intervention (NET & KIDNET) with 8-12 sessions administered on a weekly basis.
16076608|NCT02334553|Drug|S1226(8%)|The drug S1226(8%), consists of Perflubron (PFOB) and 8% CO2 delivered as an aerosol/vapour/gas mixture with a Circulaire nebulizer. The drug is administered as a single dose during the early phase asthmatic response for 2 minutes.
16076609|NCT02334553|Drug|Placebo|Normal saline nebulized with compressed medical air for 2 minutes during the early phase asthmatic response
16076610|NCT02334540|Dietary Supplement|purses|food intake
16076611|NCT02334540|Dietary Supplement|a calorie/protein matched smoothie|
16076612|NCT02334527|Drug|Palbociclib|125 mg capsule will be taken once per day orally and continuously for 3 weeks followed by 1 week off.
16076613|NCT02334501|Drug|Lansoprazole|
16076614|NCT02334501|Drug|Neratinib|
16076615|NCT02334488|Drug|Everolimus|Active Comparator
16076616|NCT02334488|Drug|Tacrolimus|Active Comparator
16076617|NCT02334488|Drug|Mycophenolate sodium|Experimental Arm
16076618|NCT02334475|Biological|Platelet Rich Plasma|single intraarticular injection of 3 ml of leukocyte free platelet rich plasma with 0.5 ml of calcium chloride(total volume 3.5 ml)
16076619|NCT02334475|Biological|methylprednisolone|single injection 1.5 ml of methylprednisolone (40mg/ml) and 1.5 ml of 2% lidocaine (20mg/ml) with 0.5 ml of saline (total volume 3.5 ml)
16076620|NCT02334462|Biological|Pfs230D1M-EPA/Alhydrogel|
16076621|NCT02334462|Biological|Pfs25M-EPA/Alhydrogel|
16076622|NCT02334462|Drug|TWINRIX|
16076623|NCT02334462|Drug|Menactra|
16076624|NCT02334449|Drug|LML134|LML134 will be administered first as single doses and then as multiple doses
16076625|NCT02334449|Drug|Placebo|All study cohorts (except food effect cohort) are placebo controlled
16076626|NCT02334436|Biological|Botulinum toxin, Type A|Botulinum toxin, Type A
16076627|NCT02334436|Other|0.9% sterile, unpreserved saline|Placebo Comparator Arm
16076628|NCT02334423|Biological|Botulinum toxin, Type A|Botulinum toxin, Type A
16076629|NCT02334423|Other|0.9% sterile, unpreserved saline|Placebo
16076630|NCT02334410|Device|Whole body vibration (WBV)|Side-alternating WBV
16076631|NCT02334397|Behavioral|Total Control Program|Women will be enrolled in Total Control, which is a fitness and education program.
16076632|NCT02334384|Biological|Antimicrobial TheraGauze|"In the intervention arm: Antimicrobial TheraGauze, tobramycin impregnated TheraGauze, will be used to pack the wound cavity after incision and drainage of the skin abscess.
~In the comparator arm: Standard wound packing, plain cotton wick or iodoform gauze - at the discretion of the provider will be used to pack the wound cavity after incision and drainage of the skin abscess."
16076633|NCT02334371|Radiation|MR-PET|The MR-PET will be performed with the Biograph mMR system (Siemens Healthcare, Erlangen, Germany). This system integrates a 3Tesla MRI and PET scan which makes simultaneous acquisition of whole-body MRI and PET images possible. The Biograph mMR holds the CE mark and was FDA approved in June 2011. The Biograph mMR is intended to be used in the Academical hospita! Maastricht for standard patient care. The radiotracer that will be used is 18F-Iabeled fluorodeoxyglucose (18F-FDG), according to standard PET -protocol.
16076634|NCT02334358|Device|YVOIRE Classic s|
16076635|NCT02334345|Drug|Evoskin|Evoskin is Trixiera is a topical agent recommended to help patients in the management of radiation skin reactions
16076636|NCT02334345|Drug|Trixiera|Trixiera is a topical agent recommended to help patients in the management of radiation skin reactions
16076637|NCT02334332|Other|Educational Intervention|Receive educational brochure
16076638|NCT02334332|Procedure|Standard Follow-Up Care|Receive standard post-operative care
16076639|NCT02334332|Procedure|Quality-of-Life Assessment|Ancillary studies
16076640|NCT02334319|Drug|Ganetespib|Given IV
16076641|NCT02334319|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16076642|NCT02334319|Other|Laboratory Biomarker Analysis|Correlative studies
16076643|NCT02334306|Biological|AMG 557/MEDI5872|Participants will receive a fixed SC dose of 210 mg MEDI5872 (AMG 557/MEDI5872) QW for 3 weeks (Days 1 to 15) and then Q2W for 9 weeks (Days 29 to 85) in double-blind period of the study. In open-label period, all participants from double-blind period will receive a fixed SC dose of 210 mg MEDI5872 from Day 99 to Day 183 (QW from Days 99 to 113 for participants from Placebo arm and on Days 99 and 113 for participants from MEDI5872 210 mg arm; and Q2W from Days 127 to 183 for participants from both arms).
16076644|NCT02334306|Other|Placebo|The SC dose of placebo every week for 3 weeks (Days 1 to 15) and then every 2 weeks for 9 weeks (Days 29 to 85) in double-blind period of the study. In open-label period, an additional dose of blinded placebo will be administered on Day 106 for participants who will receive MEDI5872 210mg in double-blinded period.
16076645|NCT02334293|Drug|Omegaven|Omegaven® fat emulsion will be used as a Compassionate Use treatment for critically ill infants with PN associated liver injury.
16076646|NCT02334280|Behavioral|In SHAPE|In SHAPE is a health promotion intervention consisting of a fitness club membership and a health promotion coach with basic certification as a fitness trainer, instruction on principles of healthy eating and nutrition, and training in tailoring individual wellness plans to the needs of persons with serious mental illness.
16076828|NCT02333162|Other|Laboratory Biomarker Analysis|Correlative studies
16076647|NCT02334267|Device|Group 1: GranuFlo|Study subjects will be randomized to undergo dialysis treatments using GranuFlo, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using NaturaLyte, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: blood and dialysate samples will be obtained at specific time points during the dialysis treatments.
16076648|NCT02334267|Device|Group 2: NaturaLyte|Study subjects will be randomized to undergo dialysis treatments using NaturaLyte, a commercially available acid dialysate concentrations for one weekly hemodialysis treatment. This will be followed by dialysis treatments using GranuFlo, a commercially available acid dialysate concentration for a second weekly hemodialysis treatment. Intervention: blood and dialysate samples will be obtained at specific time points during the dialysis treatments.
16076649|NCT02334254|Drug|rivaroxaban and ticagrel therapy|Antiplatelet therapy are mandatory at least 1 month after bare metal stent implantation, and 6 months after drug-eluting stent implantation.
16076650|NCT02334254|Drug|triple antithrombotic regimen with warfarin, asipirin and clopidogrel|
16076651|NCT02334241|Device|Sorbact®|Sorbact® is available in many types and sizes. These different presentations are available allowing management of quite all types of wounds of various anatomical locations, sizes or depths. Application of any of these presentations is allowed and may change during study course according to wound evolution.
16076652|NCT02334241|Device|Best local cares|Participating centers will provide a list of dressings they planned to use in the best local cares arm. This list must be validated by the study Steering Committee members
16076653|NCT02334228|Behavioral|In SHAPE Lifestyles|In SHAPE Lifestyles is a health promotion intervention consisting of a fitness club membership and a health promotion coach with basic certification as a fitness trainer, instruction on principles of healthy eating and nutrition, and training in tailoring individual wellness plans to the needs of persons with serious mental illness.
16076654|NCT02334228|Behavioral|Health Club Membership and Education|Fitness club membership with education in using the exercise equipment.
16076655|NCT02334215|Drug|Methadone|Interim methadone treatment (methadone without routine counseling) will be provided in jail. Methadone treatment with counseling will be continued in the community.
16076656|NCT02334215|Behavioral|Patient Navigation|A patient navigator will assist the participant for the first three months after release from jail to enter and remain in methadone treatment in the community.
16076657|NCT02334215|Behavioral|Enhanced Treatment as Usual (ETAU)|Participants will receive methadone detoxification, drug abuse and overdose prevention information, drug treatment and overdose prevention referral in the community.
16076658|NCT02334202|Behavioral|Interpersonal Psychotherapy-Weight Gain|Participants will have 1 individual pre-group session when each participant meets with the group leaders so that they can learn about each girl's significant relationships, set goals for the program, and so each girl can learn about group participation and format. Participants then will begin IPT-WG which is designed to decrease excessive weight gain among adolescents ages 12-17 years who are at risk for adult obesity. The IPT-WG program has been adapted to be appropriate for military dependents. The IPT-WG group meets for 12 consecutive, weekly group meetings and involves developing strategies for dealing with the problems girls struggle with that may lead to increased eating. At the 6th week of the group, the group leaders meet with each participant to review their progress and goals.
16076659|NCT02334202|Other|Health Education|"The health education group will follow the HEY-Durham health program designed by researchers at Duke University. This program, designed to be delivered to youth attending community high schools, was adapted to a 12-week program (each with a 90 minute session). Girls will come in for a 1.5-hour group meeting once a week for 12 weeks (12 times total). Before beginning the group, girls will meet with group leaders to review each adolescent's family health history. The curriculum includes focus on various health topics, including avoiding alcohol, drug and tobacco use, nutrition and body image, nonviolent conflict resolution, sun safety, exercise, and domestic violence."
16076660|NCT02334189|Behavioral|Letter|Patients receive an information letter following an avoidable visit to the Emergency Department.
16076661|NCT02334176|Procedure|Ultrasound guided axillary plexus block with 1 injection|The needle will be advanced until the tip is positioned just dorsal to the artery and 35ml of (lidocaine 1.5% with epinephrine 5µg/ml) is deposited in this location.
16076662|NCT02334176|Procedure|Ultrasound guided axillary plexus block with 2 injections|The needle will be initially advanced toward musculocutaneous nerve and 7 ml of LA (lidocaine 1.5% with epinephrine 5µg/ml) is deposited around the nerve. The needle will be then advanced until the tip is positioned just dorsal to the artery and 28 ml of (lidocaine 1.5% with epinephrine 5µg/ml) is deposited in this location.
16076663|NCT02334176|Drug|lidocaine 1.5% with epinephrine 5µg/ml|35 ml of lidocaine 1.5% with epinephrine 5µg/ml will be used to perform the axillary plexus block
16076664|NCT02334163|Drug|Nitazoxanide|500 mg nitazoxanide tablets twice daily
16076665|NCT02334163|Drug|Oral lactulose|Oral lactulose (65%)
16076666|NCT02334163|Drug|Metronidazole|250 mg metronidazole tablets every 8 hours
16076667|NCT02334163|Drug|Rifaximine|Two 200 mg rifaximine tablets every 8 hours
16076668|NCT02334150|Drug|CSEA (ropivocaine and sufentanil)|Women in the CSEA group received CSEA during labor. An intravenous line was established when the uterine opening measured 1-2 cm. Then sufentanil (5-7 μg) was injected intrathecally. When the visual analogue pain score was 3 or higher, a mixture of ropivocaine (0.143%) and sufentanil (0.3 μg/ml) was continuously infused into the epidural space using an analgesia pump until the cervix was fully dilated. Load capacity was 5 ml. The analgesic plane was controlled under T10.
16076669|NCT02334137|Behavioral|iPad app|"Provided by the Patient Education Institute, the X-plain iPad app includes modules on healthy eating for diabetics, eye complications, foot care, and others."
16076670|NCT02334137|Behavioral|Educator sessions|A certified diabetes educator and/or registered dietitian will meet with patients for 30-60 minutes prior to their ophthalmology visits, when scheduling permits.
16076671|NCT02334137|Behavioral|Retinal photos|A resident ophthalmologist will spend approximately 5 minutes showing patient their own retinal photos, compared to a normal retina, and explaining the pathology present (if applicable).
16076829|NCT02333149|Dietary Supplement|Melatonin|"Children <40 kg will take one tablet, melatonin 3 mg, oral, 30 - 60 minutes prior to bedtime.
~Children ≥40 kg will take two tablets, melatonin 3 mg, oral, 30-60 minutes prior to bedtime."
16076672|NCT02334124|Other|Home|The main intervention is for children with uncomplicated cellulitis to remain at home throughout the period of intravenous treatment but as it is not feasible to administer flucloxacillin four times a day by the Hospital-In-The-Home team, once daily ceftriaxone is the most ideal antibiotic to be given to this group
16076673|NCT02334124|Other|Ward|Admission to a hospital based ward
16076674|NCT02334124|Drug|ceftriaxone|50mg/kg once daily
16076675|NCT02334124|Drug|flucloxacillin|50mg/kg 6 hourly
16076676|NCT02334111|Behavioral|RESPECT-Plus|A RESPECT-Plus family specialist (FS) will deliver the intervention to subjects (mothers in treatment for opiate use disorder) recruited during their third trimester of pregnancy and randomized into the study's intervention arm post-delivery. During their infant's hospital stay, the FS will schedule a convenient time to meet the subjects (mothers) to educate them on infant soothing techniques. With permission from the mother, the FS will join the subjects during their infant's routine well-child visits at the pediatric primary site. Optional home visiting provides another meeting opportunity between the subjects and FS.
16076677|NCT02334098|Dietary Supplement|Omega-3 supplemented drink|"The drink has apple/ pear/ pomegranate taste which is well accepted by children and adolescents, is rich in natural antioxidants to help prevent oxidation of omega-3. The drink can be taken at any time during the day.
~1/3 of the participants will be assigned to the omega-3 group after randomization. They are going to take the treatment for 6 months. They will be assessed at baseline, end of treatment and 6 months post-treatment."
16076678|NCT02334098|Dietary Supplement|Smartfish|Treatment duration is 6 months. They will be assessed at baseline (0 months), end of treatment (6 months) and 6 months post-treatment (12 months).
16076679|NCT02334072|Device|Laryngeal mask classical application|Laryngeal mask classical application will be done following induction of anesthesia and anesthesia will be conducted by this device.
16076680|NCT02334072|Device|I-gel laryngeal mask application|I-gel laryngeal mask application will be done following induction of anesthesia and anesthesia will be conducted by this device.
16076681|NCT02334072|Device|Cobra laryngeal mask application|Cobra laryngeal mask application will be done following induction of anesthesia and anesthesia will be conducted by this device.
16076682|NCT02334072|Device|Supreme laryngeal mask application|Supreme laryngeal mask application will be done following induction of anesthesia and anesthesia will be conducted by this device.
16076683|NCT02334072|Device|Proseal laryngeal mask application|Proseal laryngeal mask application will be done following induction of anesthesia and anesthesia will be conducted by this device.
16076684|NCT02334059|Drug|Ketamine|Ketamine infusion plus placebo infusion of normal saline
16076685|NCT02334059|Drug|Ketamine plus magnesium|Ketamine plus magnesium infusion
16076686|NCT02334059|Other|Placebo|2 placebo infusions
16076687|NCT02334046|Drug|Remifentanil|Remifentanil was maintained at predetermined effect-site concentration during the periextubation period (initial concentration: 1.8 ng/ml) in elderly patients (65-80 years) .
16076688|NCT02334046|Drug|Remifentanil|Remifentanil was maintained at predetermined effect-site concentration during the periextubation period (initial concentration: 1.8 ng/ml) in adult patients (20-60 years) .
16076689|NCT02334046|Drug|Sevoflurane|Anesthesia was maintained with sevoflurane with 1.5-2.0 vol% in air/50%oxygen mixture, and sevoflurane was adjusted to about 1.0 vol% 10 min before end of surgery.
16076690|NCT02334033|Other|other|
16076691|NCT02334020|Other|Mental Health First-aid|2 days training course providing information on severe mental illness, in order to make people able to support in situations of crisis
16076692|NCT02334007|Drug|LMWH: Dalteparin|Dalteparin is a low-molecular weight heparin. The dosage used will be 5000 units once daily (administered as a subcutaneous injection). This is an established prophylactic dose used to prevent the incidence of VTE after surgery.
16076693|NCT02334007|Other|Placebo|Upon hospital discharge, half of the patients will be assigned to receive saline placebo injections for up to 35 days after surgery. These injections will have no effect.
16076694|NCT02333994|Device|GROUP A education programme as well as balance training exercises|Group A received education programme as well as balance training exercises.The intervention group attended one-hour training classes once a week for 6 consecutive weeks. The classes involved both lectures and discussions and were guided through with handouts and worksheets. Each session began by giving a summary of the previous session and continued with the main topic of the session. The intervention program also engaged the participants in discussions about their concerns regarding falling and on topics pertaining to identifying and reducing the risk factors of falls, including environmental hazards in and out of the house
16076695|NCT02333994|Other|GROUP B on-platform training|on-platform training was performed while standing and while sitting on a 22-inch therapeutic ball, 1 eyes open or closed 2 normal or reduced area of foot support 3 on foam or floor 4 with or without manual p
16076696|NCT02333981|Device|passive oral motor therapy for drooling|7 subjects aged 7-19 yrs were taken . All subjects received passive treatment which included light touch, stroking, vibration with (mechanical vibrator), tapping, pressure and stretch. All the techniques have been proved to be effective in treating drooling. Relative sterility and hygiene was maintained throughout the procedure as sterilized gloves and napkins were used. The measurement protocol was designed to check effectiveness on drooling in children. The protocol was given for 4 weeks with treatment sessions given 3 times per week and the treatment duration was 30min.12 sessions of oral motor stimulation therapy given during the 4 weeks..
16076697|NCT02333968|Behavioral|Self-management support|The 12-week intervention consists of an iPad application for patients that is connected to a web application for nurses. Every morning and evening patients register pain and related symptoms by use of a pain diary. Patients are also requested to register medication intake. Graphical feedback is provided based on registered pain scores and medication intakes. Patients receive education on causes and treatment of pain, symptoms that require action, and methods to better control pain. Patients communicate with nurses via text message functionality within the application. Specialized nurses remotely monitor and analyze the patients' situation once every workday. Nurses have the opportunity to collaborate with the treating physician, pain specialist or multidisciplinary team.
16076698|NCT02333955|Drug|GCS-100|3 mg GCS-100 IV push. All doses of study drug will be administered least once monthly for a total of 1 year with a follow-up 4 weeks after the last dose is administered.
16076699|NCT02333942|Device|Nautilus NeuroWaveTM System|A noninvasive device to detect dementia utilizing headset and sensors
16076704|NCT02333903|Other|Personalized Physical Activity|"1.5 hours physical training sessions, twice a week for 1 year, under the supervision of a dedicated coach specialized in supporting overweighted patients.
~Typical training session organized for small groups (5 patients) will consist of aerobic exercises, muscular strengthening (4 peripheral members and abdominal muscular belt), followed by stretching exercises."
16076705|NCT02333890|Drug|Chloroquine|chloroquine 500 mg daily as an oral capsule during the wait time to surgery.
16076706|NCT02333890|Drug|Placebo|
16076707|NCT02333877|Other|Skinlink|suture using Skinlink
16076708|NCT02333877|Other|Nylon|conventional suture using nylon
16076709|NCT02333864|Device|POGO® BGMS|SMBG
16076710|NCT02333851|Drug|Mixtard 30:70 Novonordisk® twice daily|Premixed insulin twice daily before breakfast and before dinner
16076711|NCT02333851|Drug|Lantus® once daily and Apidra® before meals|Injection of Lantus® insulin once daily and rapid insulin Apidra® before breakfast, lunch and dinner
16076712|NCT02333838|Drug|IV Thiotepa|IV Thiotepa (5 mg/Kg/day for 2 days) (Day -7 and -6) or IV Thiotepa (5 mg/Kg/day for 2 days) (Day -6)
16076713|NCT02333838|Drug|IV Fludarabine|IV fludarabine (40 mg/m²/day for 4 days) (from Day-5 to day -2)
16076714|NCT02333838|Drug|IV Busulfan|(Busilvex 130 mg/m2/day for 3 days) (Day-5, -4 and -3) or (Busilvex 100 mg/m2/day for 3 days) (Day-5, -4 and -3)
16076715|NCT02333838|Drug|IV Anti-thymocyte globuline|(Thymogobuline®, 2.5 mg/kg/day for 2 days) (Day-3 and -2)
16076716|NCT02333825|Procedure|Medial patellofemoral ligament reconstruction surgery|Medial patellofemoral ligament reconstruction surgery using hamstring autograft
16076717|NCT02333825|Other|Physical therapy and rehabilitation|A standardized physical therapy and rehabilitation program to be administered and guided by rehab specialists
16076718|NCT02333812|Other|Stroboscopic nasopharyngeal laryngoscopy|
16076719|NCT02333812|Other|Stroboscopic nasopharyngeal laryngoscopy|
16076720|NCT02333812|Other|Stroboscopic nasopharyngeal laryngoscopy|
16076721|NCT02333799|Drug|Bedaquiline|100mg tablets
16076722|NCT02333799|Drug|PA-824|200mg tablets
16076723|NCT02333799|Drug|Linezolid|Scored 600mg tablets
16076724|NCT02333786|Other|Long-axis/in-plane US-guided arterial catheterization|Cannulate the radial artery or posterior tibial artery of an infant of a preschool child putting the 24 gauge needle parallel to the ultrasound transducer.
16076725|NCT02333786|Other|Short-axis/out-of-plane US-guided arterial catheterization|Cannulate the radial artery or posterior tibial artery of an infant or a preschool child putting the 24 gauge needle perpendicular to the ultrasound transducer.
16076726|NCT02333773|Procedure|Irreversible electroporation (IRE)|Irreversible Electroportion For Unresectable Portal venous tumor emboli guide with ultrasound or/and CT.
16076727|NCT02333760|Genetic|Autologous CD34+ cells transduced with WASP lentiviral vector|Follow up of ex vivo gene therapy transplantation of patient's autologous CD34+ cells transduced with lentiviral vector containing human WASP gene
16076728|NCT02333747|Device|the Hans electronic acupuncture apparatus|TEAS was performed with a dense-disperse frequency of 2/10 Hz and an intensity of 6-9 mA for 30 min using the Hans electronic acupuncture apparatus (HANS-100A, Nanjing Jisheng Medical Technology Company, Nanjing, China).
16076729|NCT02333734|Other|Physical training|Performed supervised high intensity interval training 3 times a week over 8 weeks on a bicycle ergometer (with watt meter). During the training period, the trainee individually established program, each time with 10 × 60 sec. workout (interspersed with 60 sec. break) corresponding to a force which during the test cycle induces ~ 90% of the maximum heart rate. The time spent per session is expected to last ~ 25 minutes.
16076730|NCT02333721|Procedure|D2 lymphadenectomy including No. 10|After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic total gastrectomy with D2 lymphadenectomy including spleen-Preserving No. 10 Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy
16076731|NCT02333721|Procedure|D2 lymphadenectomy excluding No. 10|After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, Laparoscopic total gastrectomy with D2 lymphadenectomy excluding spleen-Preserving No. 10 Lymph Node Dissection will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy
16076732|NCT02333708|Other|Blood sample|
16076733|NCT02333695|Device|Spinal Magnetic Stimulation|Spinal Magnetic Stimulation (SMS) is a relatively new way to use magnetism to affect the spinal cord. It is non-invasive, meaning that the procedure does not require any type of surgery; rather, it is conducted by transmitting magnetic pulses through the Spinal Cord by pressing a machine against the back.
16076734|NCT02333682|Dietary Supplement|25(OH)D3 (Calcifediol Hy.D) 10 mcg|25(OH)D3 (Calcifediol Hy.D)
16076735|NCT02333682|Dietary Supplement|25(OH)D3 (Calcifediol Hy.D) 15 mcg|25(OH)D3 (Calcifediol Hy.D)
16076736|NCT02333682|Dietary Supplement|25(OH)D3 (Calcifediol Hy.D) 20 mcg|25(OH)D3 (Calcifediol Hy.D)
16076737|NCT02333682|Dietary Supplement|Vitamin D3 (Cholecalciferol) 20 mcg|Vitamin D3 (Cholecalciferol)
16076738|NCT02333669|Other|no intervention|no intervention
16076739|NCT02333656|Other|New OA model|"The general practitioners and the physiotherapists will attend an inter-active workshop and deliver osteoarthritis care in line with international recommendations for osteoarthritis treatment. The general practitioner will refer eligible patients to treatment by physiotherapists at Healthy Living Center or by physiotherapists in private practice. This treatment will include a standardized patient education program followed by structured exercise program with individual adjustments. The general practitioner will schedule a follow-up after the 12-week treatment and will receive a treatment report from the physiotherapist."
16076740|NCT02333643|Drug|CLS003|
16076741|NCT02333643|Drug|Furosemide|
16076742|NCT02333643|Drug|Digoxin|
16076743|NCT02333643|Drug|Vehicle topical|
16076744|NCT02333630|Other|AsthmaCare mobile health application|Personalized, interactive mobile health application designed to send daily medication reminders and assist with self management
16076745|NCT02333630|Other|Asthma education|A website with links to written asthma education and videos
16076830|NCT02333149|Drug|Placebo|Placebo frequency and volume are identical to the experimental arm
16076746|NCT02333617|Other|Dry Needling|Dry Needling will be performed on the patient's ipsilateral gluteus medius muscle with the patient in sidelying. The treating therapist will use the appropriate needle based upon patient's size and location of trigger point [No. 5 (0.25 x 40mm), No. 8 (0.30 x 50mm), or No. 11 (0.30 x 75mm)]. They will target trigger points identified in the ipsilateral gluteus medius. Once the needling is inserted into the trigger point the needle will be moved in multiple directions until the first local twitch response is noted. Once the first local twitch response is obtained, the needling will be performed in an up-and-down fashion, performing 2- to 3-mm vertical motions with no rotations (fast-in and fast-out technique), at approximately 1 Hz for 25 to 30 seconds, with the aim of eliciting local twitch responses. The treating therapist can dry needle each trigger point identified in the gluteus medius with a maximum treatment time of 5 minutes.
16076747|NCT02333617|Other|Soft Tissue Mobilization|Soft tissue mobilization will be performed on the patient's ipsilateral gluteus medius muscle with the patient in sidelying. The treating therapist will apply firm pressure with the palm and side of their hand. The treating therapist will mobilize the gluteus medius muscle in 4 separate directions (Proximal-Distal, Distal-Proximal, Medial-Lateral, and Lateral-Medial). The treating therapist will apply the pressure to reach the upper limit of the patient's tolerable discomfort. At any point in time the patient can request for the therapist to decrease the pressure applied. The treating therapist will perform soft tissue mobilization for 20 mobilizing strokes in each of the 4 directions.
16076748|NCT02333617|Other|Placebo Control|Treating therapist will place hands on the patient's gluteus medius muscle and gently rub, but not apply enough pressure to treat the muscles trigger point. This placebo control is designed to account for hands on time from therapist in the 2 other treatment groups, as well as blinding patient to treatment group.
16076749|NCT02333617|Other|Hip and core strengthening exercises|Patient will perform standardized hip and core exercises using body weight, and elastic bands for resistance. Exercises will take approximately 40 minutes to complete.
16076750|NCT02333591|Drug|GlucagonLikePeptide-1 (7-36)|Diluted in saline and human serum albumin, then infused intravenously for 2,5 hours.
16076751|NCT02333591|Drug|GlucagonLikePeptide-1 (9-36)|Diluted in saline and human serum albumin, then infused intravenously for 2,5 hours.
16076752|NCT02333591|Drug|Saline|Infused intravenously for 2,5 hours.
16076753|NCT02333578|Procedure|Convalescent Plasma Treatment|This pilot trial will treat subjects in the ECP Group with ECP derived from two donors. ECP will be provided as ECPSDU each comprising 90 - 110mL of plasma from two individual ABO-compatible donors. Two ECPSDU will be administered as immediately sequential infusions. Subjects may receive up to three doses of ECP not less than 48 hours apart. ECP will be provided as Plasma Frozen Within 24 Hours After Phlebotomy (PF24).
16076754|NCT02333565|Drug|Everolimus|
16076755|NCT02333565|Drug|Octreotide|
16076756|NCT02333539|Behavioral|Adherence behaviors and recommendations for improvement.|
16076757|NCT02333539|Behavioral|Adherence behavior that needs improvement is targeted|
16076758|NCT02333513|Drug|Lomustine/Vincristine/Procarbazine|
16076759|NCT02333500|Other|olfactory workshop|olfactory workshop
16076760|NCT02333500|Other|other workshop|other workshop: discussion group, dance and body Expression
16076761|NCT02333500|Other|No intervention|control group
16076762|NCT02333487|Drug|Lu AF35700|5 mg tablets for oral administration
16076763|NCT02333474|Biological|MV mix vaccine|MV is an intravenous intralipid suspension with 5 various vaccines, including DPT (diphtheria, pertussis, and tetanus ), BCG (Bacille Calmette-Guerin vaccine), measles, Serratia and pneumococcus. Inject 0.5 ml of the mixture subcutaneously every week. Best reaction after injection was defined as showing regional red and swollen at the injection point and mild fever and to achieve this, dose increasing or reduction is acceptable.
16076764|NCT02333474|Other|standard treatment|Patient will receive a comprehensive histological and imaging check up to evaluate the histological type, stage of the disease and performance status. Then the patient will receive standard treatment, in brief, surgical resection for early stage patients and systemic treatment including chemotherapy for advanced stage patients, according to NCCN guide line.
16076765|NCT02333461|Dietary Supplement|Placebo|Participants were randomly assigned to receive one of four botanical interventions or placebo.
16076766|NCT02333461|Dietary Supplement|Apple|Participants were randomly assigned to receive one of four botanical interventions or placebo.
16076767|NCT02333461|Dietary Supplement|Grape|Participants were randomly assigned to receive one of four botanical interventions or placebo.
16076768|NCT02333461|Dietary Supplement|Raspberry|Participants were randomly assigned to receive one of four botanical interventions or placebo.
16076769|NCT02333461|Dietary Supplement|Apricot/Nectarine|Participants were randomly assigned to receive one of four botanical interventions or placebo.
16076770|NCT02333448|Biological|Blood sample taken on the day the treatment is initiated|
16076771|NCT02333448|Biological|Blood sample taken on day 3 after initiation of treatment|
16076772|NCT02333448|Biological|Blood sample taken on day 5 after initiation of|
16076773|NCT02333448|Biological|Blood sample taken on day 7 after initiation of treatment|
16076774|NCT02333448|Biological|Blood sample taken on day 10 after initiation of treatment|
16076775|NCT02333435|Dietary Supplement|EPA|3g/day of purified EPA , capsules, taken once daily, for 14 months
16076776|NCT02333435|Dietary Supplement|Placebo|3g/day of placebo (high oleic sunflower oil) , capsules, taken once daily, for 14 months
16076777|NCT02333422|Other|NIRS Neurofeedback|The sensor will be placed on 4 specific regions defined by the International 10/20 System for Electrode Placement. F7, Fp1, Fp2 and F8. Each region will be initially trained for 4 minutes, with the eyes open, gradually increasing training time throughout the sessions to a maximum of 10 minutes. Training will amount to 24 sessions, occurring 2 times per week over a period of 3 moths. The procedure will be interrupted at any time, should the subject demonstrate the desire to stop.
16076778|NCT02333409|Procedure|Electroacupuncture|Electroacupuncture (EA) has been used as a part of Traditional Chinese Medicine (TCM) and the benefits and success of EA as a viable treatment option for acute and chronic pain of various origins have been well-recognised.electro-acupuncture (EA) is taken place as to give out the stimulation with fixed frequency, pulse width and current to acupuncture needle for further promotion of analgesics effects.
16076872|NCT02332837|Behavioral|Intervention C: Questionnaire Completion rate|Number of participants who complete the questionnaire
16076779|NCT02333396|Other|PICU Supports|The PICU Supports intervention includes navigator activities and ancillary tools. The Navigator activities include: initial visits with the healthcare team members (HTMs) and parents; weekday visits with the parents and feedback to the HTMs as needed; coordination of weekly family meetings between the parents and HTMs; and support during transitions out of the unit. The ancillary tools include: a PICU handbook; a place for parents to keep track of events and their goals; a provider sheet to inform PICU HTMs about important parental issues, concerns or goals; a bedside communication log so parents know which non-PICU HTMs have visited; an end-of-life checklist; a bereavement packet for those whose child dies; and informational resources.
16076780|NCT02333396|Other|Educational Brochure|Parents will receive a short educational brochure with information about the pediatric intensive care unit.
16076781|NCT02333383|Drug|Adalimumab|Adalimumab pre-filled syringe, administered by subcutaneous injection
16076782|NCT02333370|Drug|LEE011|LEE011 as 50 mg and 200 mg hard gelatin oral capsules as individual patient supply packaged in bottles. LEE011 will be taken QD - days 1-21 of each 28 days cycle.
16076783|NCT02333370|Drug|Letrozole|25mg
16076784|NCT02333370|Drug|Tamoxifen|20 mg
16076785|NCT02333370|Drug|Fulvestrant|500 mg
16076786|NCT02333370|Drug|goserelin|
16076787|NCT02333357|Behavioral|Multimedia 12-Step Toolkit|The Multimedia 12-Step Toolkit includes counselor written guides, posters, client worksheets, engagement activities, and videos designed to be shown during group treatment sessions to explain and encourage 12-step participation.
16076788|NCT02333357|Behavioral|Treatment as Usual|Treatment as Usual is defined as five standard 12-step facilitation group sessions as counselors would normally conduct with their clients.
16076789|NCT02333344|Drug|Zoledronic acid 5mg|two-year Zoledronic acid 5mg infusion treatment
16076790|NCT02333331|Drug|bimagrumab|Bimagrumab will be administered as an intravenous infusion starting on Day 1 until week 21.
16076791|NCT02333331|Other|placebo|Placebo will be administered as an intravenous infusion starting on Day 1 until week 21.
16076792|NCT02333318|Drug|VVZ-149 injection|Colorless, transparent liquid in water for injection
16076793|NCT02333318|Other|Placebo|water for injection
16076794|NCT02333305|Dietary Supplement|CoQ10|• 2 dosages according to patient weight: Weight < 50kg : 20 drops 3 times a day (150 mg / d) Weight ≥ 50 kg : 40 drops 3 times a day (300 mg / d)
16076795|NCT02333305|Other|Sanomit Placebo|• according to patient weight: Weight < 50kg : 20 drops 3 times a day Weight ≥ 50 kg : 40 drops 3 times a day
16076796|NCT02333292|Drug|Telaprevir|Initiation of a regimen containing TVR
16076797|NCT02333292|Drug|Boceprevir|Initiation of a regimen containing BOC
16076798|NCT02333292|Drug|Sofosbuvir|Initiation of a regimen containing SOF
16076799|NCT02333292|Drug|Simeprevir|Initiation of a regimen containing SMV
16076800|NCT02333292|Drug|Daclatasvir|Initiation of a regimen containing DCV
16076801|NCT02333292|Drug|Ledipasvir|Initiation of a regimen containing LDV
16076802|NCT02333292|Drug|ritonavir-boosted Paritaprevir/ Ombitasvir|Initiation of a drug combination of PTV/OTV
16076803|NCT02333292|Drug|Dasabuvir|Initiation of a regimen containing DBV
16076804|NCT02333292|Drug|Velpatasvir|Initiation of a regimen containing VPV
16076805|NCT02333292|Drug|Elbasvir|Initiation of a regimen containing EBV
16076806|NCT02333292|Drug|Grazoprevir|Initiation of a regimen containing GZR
16076807|NCT02333266|Other|Candidemia|
16076808|NCT02333253|Drug|cetrotide|0.25 cetrotide S.c was added on when leading follicle reach >12 mm
16076809|NCT02333240|Other|Self-management of postnatal anti-hypertensive treatment|Daily use of a validated home blood pressure monitor in conjunction with an individualised medication adjustment schedule to adjust anti-hypertensive medications in line with blood pressure readings.
16076810|NCT02333227|Dietary Supplement|Xylitol gum|This is a cluster randomized trial, whereby 4 sites will receive the intervention of xylitol gum in the prepregnancy and early pregnancy interval.
16076811|NCT02333214|Other|Exergames and conventional physiotherapy|The protocol of conventional physiotherapy will be customized and will include exercises to improve strength and muscle power, flexibility, mobility, balance, and aerobic conditioning exercises. In particular cases, when necessary analgesia will be used to relive pain. The progression of the exercises will be individualized according to the treatment plan established in the initial functional assessment and will be target to meet patient's improvement during treatment. Conventional physiotherapy will be conducted in pairs. In this group exercises that are best accomplished using virtual scenarios, such as dual task exercises, anticipatory adjustments exercises and inter limb coordination exercises will be performed using video games.
16076812|NCT02333214|Other|Conventional physiotherapy|The protocol of conventional physiotherapy will be customized and will include exercises to improve strength and muscle power, flexibility, mobility, balance, and aerobic conditioning exercises. In particular cases, when necessary analgesia will be used to relive pain. The progression of the exercises will be individualized according to the treatment plan established in the initial functional assessment and will be target to meet patient's improvement during treatment. Conventional physiotherapy will be conducted in pairs. In this group dual task exercises, anticipatory adjustments exercises and inter limb coordination exercises will be performed without the virtual environment.
16076813|NCT02333188|Drug|Paclitaxel Albumin-Stabilized Nanoparticle Formulation|Given IV
16076814|NCT02333188|Drug|Leucovorin Calcium|Given IV
16076815|NCT02333188|Drug|Irinotecan Hydrochloride|Given IV
16076816|NCT02333188|Drug|Fluorouracil|Given IV
16076817|NCT02333188|Other|Laboratory Biomarker Analysis|Correlative studies
16076818|NCT02333175|Other|Specialist review|Specialist review with individually tailored treatment strategies suggested by specialist
16076819|NCT02333162|Drug|Fludarabine Phosphate|Given IV
16076820|NCT02333162|Drug|Melphalan|Given IV
16076821|NCT02333162|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMTMI
16076822|NCT02333162|Radiation|Total Marrow Irradiation|Undergo IMTMI
16076823|NCT02333162|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic PBSCT
16076824|NCT02333162|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo allogeneic PBSCT
16076825|NCT02333162|Procedure|Allogeneic Bone Marrow Transplantation|Undergo allogeneic BMT
16076826|NCT02333162|Drug|Tacrolimus|Given IV or PO
16076831|NCT02333136|Device|raman spectroscopy (LighTouch)|near infrared light will be shone upon a fingerbed capillary and light scatter measured using in vivo raman spectroscpy
16076832|NCT02333123|Drug|Aspirin|Each 300mg aspirin capsule will contain over-encapsulated 4 x Aspirin 75mg tablets.
16076833|NCT02333123|Drug|Placebo (for Aspirin)|Each placebo capsule will contain a lactose and magnesium stearate blend, and will appear identical in weight, colour and size to the matched aspirin capsules.
16076834|NCT02333110|Radiation|spatially fractionated radiation therapy|A single dose of 15-20Gys of spatially fractionated radiation therapy
16076835|NCT02333084|Dietary Supplement|PRN Joint Health Formula|
16076836|NCT02333084|Dietary Supplement|placebo|
16076837|NCT02333084|Dietary Supplement|PRN Flex Omega Benefits® combination|
16076838|NCT02333071|Drug|Bremelanotide|A melanocortin agonist and synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone)
16076839|NCT02333071|Other|Placebo|Placebo
16076840|NCT02333058|Drug|Treosulfan|"Treosulfan dose per day is to be calculated by using BSA:
~One dose of Treosulfan per day on three consecutive days (day -6, day -5 and day -4) as intravenous (i.v.) infusion, given over 2 hours.
~Two background conditioning regimens with Treosulfan are allowed: One regimen consists of a standardised Fludarabine-containing regimen (regimen A) and the other consists of an intensified regimen with Fludarabine and ThioTEPA (regimen B). The investigator decides for each individual patient whether to treat the patient with regimen A or with regimen B.
~Treosulfan: i.v., BSA adapted: 10, 12 or 14 g/m²/day within 120 min to be administered prior to Fludarabine; Fludarabine: i.v., 30 mg/m2/day on days from -7 to -3 prior to HSCT; ThioTEPA (Regimen B): i.v., 2 x 5mg/kg/day on day -2."
16076841|NCT02333045|Drug|Truvada qd|Truvada 1 tablet PO daily for 7 days
16076842|NCT02333045|Drug|Maraviroc 300 qd|Maraviroc 300 mg PO daily for 7 days
16076843|NCT02333032|Other|Inclined treadmill training|
16076844|NCT02333019|Behavioral|Let's Talk About Sex|Multimedia web site to build parental skills in communicating with their pre-adolescnet child sex and relationships, pregnancy prevention, and risk of sexually transmitted infections.
16076845|NCT02333019|Behavioral|Websites; preventing teen pregnancy|Two general web sites with information about preventing teen pregnancy
16076846|NCT02333006|Other|Questionnaires|Traumatic brain injury patients and participant without neurological deficits will answer to questionnaires about Anosognosia
16076847|NCT02332993|Dietary Supplement|FPP|Made from Carica papaya and represents a sweet and granular substance available over the counter. FPP possesses antioxidant properties that can provide benefit against age-related complications..
16076848|NCT02332980|Drug|Ibrutinib|Given PO
16076849|NCT02332980|Drug|Idelalisib|Given PO
16076850|NCT02332980|Other|Laboratory Biomarker Analysis|Correlative studies
16076851|NCT02332980|Biological|Pembrolizumab|Given IV
16076852|NCT02332967|Other|Whey predominant starter formula|Milk powder product given to babies between 1 week and 4 months
16076853|NCT02332967|Other|Whey predominant starter formula + 40% palmitic acid|Milk powder product containing 40% of palmitic acid
16076854|NCT02332967|Other|Whey predominant starter formula + 50% palmitic acid|Milk powder product containing 50% of palmitic acid
16076855|NCT02332954|Drug|vortioxetine|The starting and recommended dose of vortioxetine is 10 mg once daily; film-coated 10 mg tablets for oral use once daily for 52 weeks.Depending on individual patient response, the dose may be increased to a maximum of 20 mg daily.
16076856|NCT02332941|Drug|Rituximab|The purpose of this study is to determine if treatment of Age Related Macular Degeneration (AMD) with a new medication,rituximab is effective.
16076859|NCT02332915|Behavioral|Sound Production Treatment (SPT)|SPT is a behavioral treatment for acquired apraxia of speech. It involves verbal modeling of target words by the clinician, simultaneous productions, articulatory placement instructions, and repeated practice. Treatment is administered in the context of an hierarchy.
16076860|NCT02332902|Drug|Everolimus|Everyone in the study will receive Everolimus at a starting dose of 10 mg daily and will be adjusted up or down by 2.5 mg at 2 week intervals to attain a trough concentration of 5-15 ng/ml
16076861|NCT02332889|Biological|Vaccine (autologous dendritic cells)|Prior to vaccination, DC will be thawed, washed once with normal saline containing 1% human serum albumin, and viability will be checked (must be > 70%). Peptide pulsed DC will be placed in 1 ml tuberculin syringe(s) and transferred to the study physician for vaccination
16076862|NCT02332889|Drug|Decitabine and Hiltonol|Patients will receive DAC at a dose of 10 mg/m2/d intravenously (IV) over one hour on days 1-5 of week 1. Hiltonol will be given intramuscularly at the same site immediately following vaccine
16076863|NCT02332876|Behavioral|Exercise|
16076864|NCT02332876|Behavioral|Control|
16076865|NCT02332863|Device|Back-loaded Needle (Device)|"Fiducial marker placement via a traditional 22G back-loaded needle will be performed with multiple endpoints recorded:
~total length of procedure
~how many markers are successfully deployed
~technical success
~Fiducial marker location will be confirmed via fluoroscopy at time of placement and on 4D treatment planning CT ordered by the radiation oncologist for simulation."
16076866|NCT02332863|Device|Preloaded Needle (Device)|"Fiducial marker placement via a novel 22G preloaded needle will be performed with multiple endpoints recorded:
~total length of procedure
~how many markers are successfully deployed
~technical success
~Fiducial marker location will be confirmed via fluoroscopy at time of placement and on 4D treatment planning CT ordered by the radiation oncologist for simulation."
16076867|NCT02332850|Biological|Isatuximab|Given IV
16076868|NCT02332850|Drug|Carfilzomib|Given IV
16076869|NCT02332850|Drug|Dexamethasone|Given IV or PO
16076870|NCT02332837|Behavioral|Intervention A: Questionnaire accuracy|Participants will be tested by questionnaire to measure how well consent is understood
16076871|NCT02332837|Behavioral|Intervention B: Questionnaire speed of completion|Time to complete questionnaire from time of presentation
16076875|NCT02332824|Drug|Candesartan cilexetil|Candesartan cilexetil tablets
16076876|NCT02332824|Drug|Candesartan cilexetil Placebo|Candesartan cilexetil placebo-matching tablets
16076877|NCT02332811|Drug|sevelamer carbonate 800mg|"Pharmaceutical form:tablet
~Route of administration: oral"
16076878|NCT02332811|Drug|sevelamer carbonate 2.4 g|"Pharmaceutical form:powder
~Route of administration: oral"
16076881|NCT02332785|Other|Data Collection|Data collection of endoscopy procedure reports of participants with serrated polyps at MD Anderson Cancer Center in Houston, Texas.
16076882|NCT02332772|Other|Data Collection|Data collected from endoscopy procedures.
16076883|NCT02332759|Device|Materna Medical|
16076884|NCT02332733|Biological|TV003|10^3 plaque forming units (PFU) of rDEN1 delta 30, 10^3 PFU of rDEN2/4 delta 30(ME), 10^3 PFU of rDEN3 delta 30/31-7164, and 10^3 PFU of rDEN4 delta 30 to be administered as 0.5 mL by subcutaneous injection in the deltoid region of the upper arm or the thigh in pediatric participants
16076885|NCT02332733|Biological|Placebo for TV003|To be administered as 0.5 mL by subcutaneous injection in the deltoid region of the upper arm or the thigh in pediatric participants
16076886|NCT02332720|Drug|Grazoprevir|Part A: one grazoprevir 100 mg tablet taken q.d. by mouth.
16076887|NCT02332720|Drug|Uprifosbuvir|Part A: two or three uprifosbuvir 150 mg (300 or 450 mg total daily dose) tablets taken q.d. by mouth.
16076888|NCT02332720|Drug|Elbasvir|Part A: one elbasvir 50 mg tablet taken q.d. by mouth.
16076889|NCT02332720|Drug|Ruzasvir|Part A: six ruzasvir 10 mg (60 mg total daily dose) capsules taken q.d. by mouth.
16076890|NCT02332720|Drug|MK-3682B|Part B and Part C: two FDC tablets, each containing grazoprevir 50 mg + elbasvir 225 mg + ruzasvir 30 mg, taken q.d. by mouth.
16076891|NCT02332720|Drug|Ribavirin (RBV)|Part B and Part C: RBV 200 mg capsules taken b.i.d. by mouth at a total daily dose of 800 mg - 1400 mg based on participant body weight.
16076892|NCT02332707|Drug|Grazoprevir|One GZR 100 mg tablet (Part A), or 2 FDC tablets containing GZR 50 mg per tablet (Part B), taken q.d.by mouth.
16076893|NCT02332707|Drug|Uprifosbuvir|Two or 3 UPR 150 mg (300 mg and 450 mg total daily dose) tablets (Part A), or 2 FDC tablets containing UPR 225 mg (Part B), taken q.d. by mouth.
16076894|NCT02332707|Drug|Elbasvir|One EBR 50 mg tablet (Part A), taken q.d. by mouth.
16076895|NCT02332707|Drug|Ruzasvir|Six RZR 10 mg (60 mg total daily dose) capsules (Part A), or 2 FDC tablets containing RZR 30 mg per tablet (Part B), taken q.d. by mouth.
16076896|NCT02332707|Drug|Uprifosbuvir (+) Grazoprevir (+) Ruzasvir|Two FDC tablets, each containing GZR 50 mg + UPR 225 mg + RZR 30 mg (Part B), taken q.d. by mouth.
16076897|NCT02332707|Drug|Ribavirin|RBV 200 mg capsules taken b.i.d. at a total daily dose of 800-1400 mg based on participant body weight.
16076898|NCT02332694|Device|The Whole Body Hyperthermia system uses water-filtered infrared-A (wIRA) heat radiation|The Whole Body Hyperthermia system uses water-filtered infrared-A (wIRA) heat radiation. The rise in the body's core temperature is correspondingly rapid and well-tolerated. There are two phases of the thermal challenge, 1) Irradiation phase during which the patient lies recumbent with his/her head positioned outside the tent. The wIRA irradiators are arranged above the exposed upper part of the body; and 2) Heat retention phase during which the patient lies in the chamber with the walls of the tent positioned to retain heat. Core body temperatures will be raised to those comparable to a mild fever 37.8-38.5°C.
16076899|NCT02332668|Biological|Pembrolizumab|IV infusion
16076900|NCT02332655|Drug|Cannabidiol|"Initiation of treatment will begin with 2mg/kg/day. The dose will be increased by 3 mg/kg/day after seven days and then by 5 mg/kg/day every seven days up to a maximum dose of 25 mg/kg/day given.
~The dose of concomitant antiepileptic drugs will remain unchanged during the first 12 weeks of CBD treatment (or until 8 weeks after steady state at final dose), unless symptoms of toxicity and/or significant changes in blood levels are observed."
16076901|NCT02332642|Other|Immuno-monitoring|
16076902|NCT02332629|Drug|Methylprednisolone|Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride
16076903|NCT02332629|Drug|Isotonic Sodium Chloride|Placebo
16076904|NCT02332616|Drug|Methylprednisolone|Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride
16076905|NCT02332616|Drug|Isotonic Sodium Chloride|Placebo
16076906|NCT02332603|Drug|Methylprednisolone|Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride
16076907|NCT02332603|Drug|Isotonic Sodium Chloride|Placebo
16076908|NCT02332590|Drug|Sarilumab|Pharmaceutical form: solution for injection in pre-filled syringe; Route of administration: SC
16076909|NCT02332590|Drug|Adalimumab|Pharmaceutical form:solution for injection in pre-filled syringe; Route of administration: SC
16076910|NCT02332590|Drug|Placebo (for sarilumab)|Pharmaceutical form: solution for injection in pre-filled syringe; Route of administration: SC
16076911|NCT02332590|Drug|Placebo (for adalimumab)|Pharmaceutical form:solution for injection in pre-filled syringe; Route of administration: SC
16076916|NCT02332564|Other|Coronary Artery Balloon Occlusion for Determination of Collateral Flow Index|Coronary Artery Balloon Occlusion for Determination of Collateral Flow Index
16076917|NCT02332551|Device|NanoKnife|Irreversible electroporation (IRE) is a new, minima-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels,bile ducts and the gallbladder .
16076918|NCT02332538|Procedure|532nm-laser photoselective vapo-enucleation of the prostate)|using Greenlight (532nm-laser) modified vaporization technique, PVEP (photoselective vapo-enucleation of the prostate)
16076919|NCT02332538|Procedure|Holmium laser enucleation of prostate|Holmium-Yag laser enucleation of the prsotate
16076920|NCT02332538|Procedure|Bipolar TURP|Bipolar transurethral resection of the prostate in saline
16076921|NCT02332525|Device|Oral Vibrational Stimulation|"Oral application of vibratory stimulus
~: With the oral equipment, which is similar to the device generally used to prevent teeth grinding in dental clinics, 15-second vibratory and 15-second non-vibratory stimulus are given repeatedly for about 5 minutes using a vibrator that has a strength less than or equal to the vibratory stimulus of a smartphone (3.3V, 166Hz, maximum 180Hz). A stimulus of two times for 5 minutes, a total of at least 10 minutes is conducted for 10 days in a hospital or designated place."
16076922|NCT02332512|Drug|Apatinib|
16076923|NCT02332512|Drug|Placebo|
16076924|NCT02332499|Drug|Anlotinib|Anlotinib p.o. qd
16076925|NCT02332499|Drug|Placebo|Placebo p.o. qd
16076926|NCT02332486|Drug|Qingxuan Decoction|In Qingxuan Decoction, there are a bag of Chinese honeylocust spine，Glehnia littoralis and Smilax china L,and two bags of Silktree albizia bark, Kadsura interior,Cortex dictamni, Lilium brownii var, Silkworm larva,Forsythia suspensa and Rhizoma polygonati preparata, and three bags of viridulumArisaema erubescens and Poria cocos Wolf. All drugs are made by Jiangyin Tianjiang company in China.
16076927|NCT02332473|Drug|Ypeginterferon alfa-2b|
16076928|NCT02332473|Drug|Granulocyte-macrophage colony stimulating factor|
16076929|NCT02332447|Drug|naloxone|"A single dose of 1 ml of naloxone (i.e 0.4 mg) or placebo will be administered by the supervising nurse or physician, using direct intravenous injection with a 5 ml syringe through peripheral venous catheter of which all patients will be equipped throughout the video-EEG.
~The evolution from a partial seizure to a GTCS being gradual, and the total duration of the seizure ranging from 2 to 3 minutes, the injection will be prepared during the course of the seizure. Given the assumptions about the role of endogenous opioids release in the spontaneous termination of seizures, naloxone will be administrated immediately after the end of the GTCS and not before. Specifically, treatment administration will be performed within the 2 minutes following the end of the GTCS."
16076930|NCT02332447|Drug|Placebo|"Placebo will be isotonic sodium chloride which preparation in 1 ml vials will be centralized by the pharmaceutical department of Edouard Herriot Hospital to ensure its indistinguishability from naloxone A single dose of 1 ml of naloxone (i.e 0.4 mg) or placebo will be administered by the supervising nurse or physician, using direct intravenous injection with a 5 ml syringe through peripheral venous catheter of which all patients will be equipped throughout the video-EEG.
~The evolution from a partial seizure to a GTCS being gradual, and the total duration of the seizure ranging from 2 to 3 minutes, the injection will be prepared during the course of the seizure. Given the assumptions about the role of endogenous opioids release in the spontaneous termination of seizures, naloxone will be administrated immediately after the end of the GTCS and not before. Specifically, treatment administration will be performed within the 2 minutes following the end of the GTCS."
16076931|NCT02332434|Other|stable isotope enrichment methodology (5,5,5-D3-L-Leucine)|
16076932|NCT02332421|Device|modified dentoalveolar distractor|Here, the modified distractor is going to be used when retracting the canine.
16076933|NCT02332408|Radiation|Cybernetic microradiosurgery|Cybernetic microradiosurgery (6MV) using tracking to TD 25Gy given in five fraction (5Gy p fr) two or three days a week, during 2 weeks
16076934|NCT02332408|Radiation|Conventional radiotherapy|Conventionally fractionated linac based external beam radiation therapy - EBRT, (conformal or dynamic) to the TD of 36 Gy, in 2.0 Gy per fraction 5 days a week over the period of 3.5 weeks)
16076935|NCT02332369|Device|Capsular Tension Ring|
16076936|NCT02332356|Drug|azathioprine or adalimumab and infliximab|
16076937|NCT02332343|Other|No intervention - Natural history study|
16076938|NCT02332330|Device|VEST|
16076939|NCT02332317|Behavioral|Palliative rehabilitation|12-week individually customized, specialized palliative rehabilitation program
16076940|NCT02332304|Procedure|Preterm fetus|A sample of amniotic fluid was taken before the birth of fetus between 26 and 36 6/7 weeks of pregnancy.
16076941|NCT02332291|Drug|Escitalopram|Escitalopram 10-20mg daily
16076942|NCT02332291|Drug|Bupropion XL|Bupropion XL 150-450mg daily
16076943|NCT02332278|Procedure|Early feeding|Fluid diet four hours after cesarean section
16076944|NCT02332278|Procedure|Late feeding|Fluid diet 12 hours after cesarean section
16076945|NCT02332265|Other|Support to Able-Bodied Vulnerable groups to Achieve Food Security (SAFE)|The SAFE program was developed & implemented from Jan. 2008-Dec. 2010 by CARE-Malawi, a country office of CARE International, a large NGO. SAFE participants were selected by CARE-Malawi. SAFE was designed to address intertwined structural issues contributing to HIV susceptibility: food insecurity, poverty, gender inequity and ineffective governance. SAFE was implemented in 3 geographic subdivisions (Njombwa, Kaomba, & Mwase) of Kasungu District, located in west-central Malawi. It was funded primarily by the European Commission & partially by the Austrian Development Cooperation. SAFE had 4 main components: 1) improving farming practices & sustainable agriculture through Farmer Field Schools, 2) increasing access to savings and investment through Village Savings & Loans Groups, 3) building capacity of local governance structures & 4) integrating HIV education & gender empowerment into programs through training & education. Details: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4082534/.
16076946|NCT02332252|Device|Scalpel|Skin incision performed with a scalpel during cesarean section.
16076947|NCT02332252|Device|Electrocautery|Skin incision performed with an electrocautery during cesarean section.
16076948|NCT02332252|Procedure|Skin incision|
16076949|NCT02332239|Behavioral|iDOVE Intervention (ED+text)|"In-ED brief session, introducing basic principles of cognitive behavioral theory and the structure of the text-message portion of the intervention
~Eight-week longitudinal tailored text-message program"
16076950|NCT02332239|Behavioral|Control (EUC)|"In-ED brief session, discussing home safety & nutrition
~Eight-week longitudinal home safety & nutrition text-message program"
16076951|NCT02332226|Behavioral|Representational approach|Representational approach to patient education
16076952|NCT02332213|Procedure|Breath sampling for volatile marker detection|Acquisition of two exhaled breath samples of alveolar air to be analysed by GCMS and nanosensor technology
16076953|NCT02332213|Procedure|Upper endoscopy with biopsies|Upper endoscopy with proper biopsy work-up will be used for identification and stratification of gastric lesions as well as acquisition of biopsies for microbiota testing
16076954|NCT02332213|Procedure|Colonoscopy with biopsies or lesion removal when required|Colonoscopy with proper biopsy or polypectomy material work-up will be used for identification and stratification of colorectal lesions as well as acquisition of biopsies for microbiota testing
16076955|NCT02332213|Procedure|Plasma/serum sampling|Plasma/serum sampling will be used to obtain information for group stratification, e.g. H.pylori status determination
16076956|NCT02332213|Procedure|Faecal sample acquisition|Faecal samples will be obtained for faecal occult blood testing as well as microbiota analysis
16076957|NCT02332213|Procedure|Histological evaluation of the surgery material|The material obtained during surgery (stomach or colorectal) will be used for confirmation of the diagnosis in cancer groups. Surgery itself will be performed according to the clinical indications, and will not be extended (i.e. cannot be considered a study intervention)
16076958|NCT02332200|Other|Physical Therapy|Physical therapy will consist of standard physical therapy care for spondylolysis or spondylolisthesis.
16076959|NCT02332187|Device|Active electrical stimulation using an All Stim stimulator|This is an FDA approved stimulator that is used for strengthening the quadriceps muscle.
16076960|NCT02332187|Device|Sham electrical stimulation using an All Stim stimulator|With this intervention the All Stim unit is turned off and no electrical stimulation is provided.
16076961|NCT02332174|Drug|rufinamide|comparison of different doses, sex and medication conditions
16076962|NCT02332161|Other|surveys, evaluative tests for leg function|See outcome measures
16076963|NCT02332148|Drug|3VM1001|3VM1001 topical cream for treatment of osteoarthritis of the knee
16076964|NCT02332148|Drug|Placebo for 3VM1001|Topical cream placebo for 3VM1001; cream without 3VM1001
16076965|NCT02332135|Procedure|microwave ablation|First, the investigators detect the iPTH levels of all the patients in the investigators' blood purification center. The patients whose iPTH are between 300pg/ml and 800pg/ml and who have parathyroid nodular or diffuse hyperplasia demonstrated on ultrasound imaging or radioisotope scan are chosen to involve in this study. Patients are divided into 2 groups at random, the control group and the microwave ablation group. In the microwave ablation group, patients will accept microwave ablation. Oral medicines, if needed, will be taken according to the the suggestions in K/DOQI guideline.
16076966|NCT02332135|Drug|active vitamin D|The control group will be treated by active vitamin D and other general treatment,such as dietary phosphate restriction and phosphate binders,according to the suggestions in K/DOQI guideline.
16076967|NCT02332122|Procedure|Sputum induction|Patients will have to puff 200µg of salbutamol (metered-dose inhaler with spacer device). After 10 minutes FEV1 will be measured with MIR spirobank. If FEV1 is >= 30% we can safely proceed with sputum induction. An ultrasonic nebulizer will be used to induce sputum. 4% sodiumchloride will be inhaled. Induction will be performed at 5-min intervals until a sample of good quality is obtained. Sodiumchloride of 5% will be used if no good sample is obtained after two intervals with the 4% solution. Maximal time of induction will be 20 minutes. Subjects will spit saliva into one container and rinse the mouth thoroughly with water before coughing sputum into another sterile container. Samples will be refrigerated at 4°C and processed within 24 hours of collection.
16076968|NCT02332122|Procedure|Skin prick test|Skin Prick Test is a reliable method to diagnose IgE-mediated allergic disease. It is minimally invasive and results are immediately available. Interpretation utilizes the presence and degree of cutaneous reactivity as a surrogate marker for sensitization. A positive control, a negative control and Aspergillus fumigatus will be tested. Location will be Protocol version 1 3/11/2014 marked on the volar aspect of the forearm and drops of each solution will be placed (>= 2cm between drops). A single-head metal lancet will be pressed through the drop of allergen extract and held against the skin for at least 1 second. A new lancet will be utilized for each drop. A wheal diameter of >= 3mm is a positive result.
16076969|NCT02332122|Other|Questionnaires|MRC: Medical Research Council Scale CAT: COPD Assessment Test SGRQ: Saint George's respiratory questionnaire
16076970|NCT02332109|Device|ODM 5|ODM 5 is a CE-certified, preservative-free, hyperosmolar ophthalmological solution containing 5% sodium chloride and 0.15% sodium hyaluronate recommended for the reduction of corneal edema. The patient will use ODM 5 on a daily basis in accordance with the instructions for use and as recommended by the investigator over a period of 8 weeks.
16076971|NCT02332096|Device|Home Sleep Testing Device|Patients will undergo obstructive sleep apnea screening with a FDA approved home sleep testing device.
16076972|NCT02332083|Device|SR-WBV|Participants will undergo a training program set over eight weeks, three times a week with 3 to 6 Hz, Noise 4.
16076973|NCT02332083|Device|Exergame|Participants will undergo a training program set from week 5 to 8, three times a week over 20 minutes.
16076974|NCT02332083|Other|SR-WBV|Participants will undergo a training program set over eight weeks three times a week with 1 Hz, Noise 1
16076975|NCT02332083|Device|Aktiv Tramp|Participants will undergo a training program set from the 5 to 8 week, three times a week over 4 minutes.
16076976|NCT02332070|Procedure|cardiac surgery|coronary artery bypass surgery and or cardiac valve surgery with cardiopulmonary bypass
16076977|NCT02332057|Drug|Diclofenac plus lidocaine|The study nurse will instruct the patients to swallow diclofenac tablets (100 mg) 1 hour before IUD insertion. Three millilitres of the lidocaine gel will be placed on the anterior lip of the cervix . A cotton swab socked in 3 ml of the lidocaine gel will be introduced in the cervical canal till the level of internal os. The cotton swab will be left in place for three minutes. The IUD will be inserted by experienced gynecologists according to the recommendations of manufacture.
16076978|NCT02332057|Drug|Placebo|The study nurse will instruct the patients to swallow placebo tablets 1 hour before IUD insertion. Three millilitres of the placebo gel will be placed on the anterior lip of the cervix . A cotton swab socked in 3 ml of the placebo gel will be introduced in the cervical canal till the level of internal os. The cotton swab will be left in place for three minutes. The IUD will be inserted by experienced gynecologists according to the recommendations of manufacture.
16076979|NCT02332044|Drug|Erdos|capsule, 300mg
16076980|NCT02332044|Drug|Talion|tablet, 10mg
16076981|NCT02332044|Drug|Erdos, Talion|capsule 300mg and tablet 10mg
16076982|NCT02332031|Drug|Sorafenib (Nexavar, BAY43-9006)|Single dose of 400 mg orally on Period 1 Day 1 and Period 2 Day 11
16076983|NCT02332031|Drug|Levothyroxine|Single dose of 300 mcq orally from Period 2 Day 1 to Period 2 Day 14
16076984|NCT02332018|Radiation|Biplanar x-ray images|biplanar x-ray images with microdose and low-dose protocol
16076985|NCT02332005|Drug|diepalrestat choline|aldose reductase inhibitor
16076986|NCT02332005|Drug|Placebo|Placebo
16076987|NCT02331992|Behavioral|Adherence program|Participants will receive supportive messages while enrolled in the program.
16076988|NCT02331979|Device|Electromagnetic Neuromodulation|Electromagnetic stimulation to neuromodulate the spinal cord in the context of spinal cord injury.
16076989|NCT02331940|Drug|tiotropium|Comparison of the effect of tiotropium delivered by the Respimat Soft Mist Inhaler versus the HandiHaler on sleeping oxygen saturation and sleep quality in patients with COPD.
16076990|NCT02331940|Device|Handihaler|Inhalation via the HandiHaler once daily
16076991|NCT02331940|Device|Respimat|Inhalation via the Respimat once daily
16076992|NCT02331927|Biological|Aflibercept|"Early marker-driven switch of antiangiogenic treatment (bevacizumab to aflibercept) maintaining the chemotherapy backbone until definite radiological progression.
~compared to a conventional treatment approach of changing chemotherapy and antiangiogenic agent at time of radiologic progression."
16076993|NCT02331914|Procedure|Vena puncture for blood collection|GIST patients will be asked to provide 40ml blood that will be collected in four Na-EDTA 10ml blood collection tubes at every routine outpatient visit.
16076994|NCT02331914|Procedure|Tumor biopsy|Tumor biopsy after disease progression
16076995|NCT02331888|Device|Scalp electrode, fetal doppler and EUM|the parturient will be connected to the routine fetal Doppler and to the EUM. and When necessary to the scalp electrode will be connected. Tracings will be recorded simultaneously from all three devices until delivery. three separate outputs will be processed Output of the scalp electrode recording. Output of the fetal doppler. Output of the EUM. Three noncontinuous segments of 30 minutes each with two segments occurring during the first stage of labor and the third occurring during the second stage of labor, will be randomly picked from the scalp electrode recording with 3 matching segments in time from the EUM100pro and the fetal doppler.
16076996|NCT02331875|Drug|IPH2201|The first 6 patients will receive IPH2201, IV, at a dose of 4 mg/kg q2w x 4. Subsequent patients will be treated at a dose of 10 mg/kg q2w x 4.
16076997|NCT02331875|Procedure|Standard Surgery|After the end of treatment with IPH2201, according to standard recommendations in the relevant country .
16076998|NCT02331875|Radiation|Postsurgical Adjuvant Therapy|After the standard surgery, according to standard recommendations in the relevant country
16076999|NCT02331862|Drug|Methylprednisolone|Add methylprednisolone in addition to the experience antibiotics in children with urinary tract infection to see if the frequency of the renal scar formation could be decreased
16077000|NCT02331849|Device|High resolution manometry (HRM)|High resolution manometry of the esophagus
16077001|NCT02331836|Device|Arc Endocuff (AEC 110, 120, 130, 140)|
16077002|NCT02331836|Device|Cap|Olympus Disposable distal attachment 15mm diameter, 4mm depth
16077003|NCT02331836|Device|Standard colonoscope|
16077004|NCT02331823|Drug|Isoniazid Aminosalicylate Tablets|a regimen consists of 5 anti-TB drugs (Isoniazid Aminosalicylate Tablets+pyrazinamide tablets+ethambutol tablets+rifabutin capsules+moxifloxacin tablets)to treat retreatment pulmonary tuberculosis patients. The total treatment course is 5 months.
16077005|NCT02331823|Drug|Streptomycin injectable|standardized regimen 2 months of streptomycin injectable + isoniazid tablets + ethambutol tablets + rifampicin capsules + pyrazinamide tablets and 6 months of isoniazid tablets + ethambutol tablets + rifampicin capsules or 3 months of isoniazid tablets + ethambutol tablets + rifampicin capsules + pyrazinamide tablets and 6 months of isoniazid tablets + ethambutol tablets + rifampicin capsules to treat Arm B patients as a control to arm A.The treatment course is 8-9 months.
16077006|NCT02331810|Drug|SAR113244|Pharmaceutical form:solution for injection Route of administration: subcutaneous
16077007|NCT02331810|Drug|placebo|Pharmaceutical form:solution for injection Route of administration: subcutaneous
16077008|NCT02331797|Device|Endoscopic Technique|Endoscopic Technique; endoscopic transcanal lateral graft tympanoplasty using An endoscope (Karl Storz, Tuttlingen, Germany) and A microdrill (Skeeter Otologic Drill System; Medtronic Xom ed Surgical Products, Inc., Jacksonville, FL, USA)
16077009|NCT02331797|Device|Microscopic Technique|Microsopic surgical approach using a Zeiss Opmi 111 (Carl Zeiss, Jena, Germany) operating microscope
16077010|NCT02331784|Behavioral|Computerized Plasticity-based Software|Participants will be asked to use their assigned training program for forty minutes per session, up to five sessions per week, over 10 weeks (50 total sessions).
16077011|NCT02331784|Behavioral|Commercially available Video Game|Participants will be asked to use their assigned video games for forty minutes per session, up to five sessions per week, over 10 weeks (50 total sessions).
16077012|NCT02331771|Drug|Donepezil|Donepezil 5 mg once daily 2 days before ECT and continuing through the last ECT procedure.
16077013|NCT02331771|Drug|Placebo|Placebo capsule once daily 2 days before ECT and continuing through the last ECT procedure.
16077014|NCT02331758|Behavioral|Lifestyle Counseling|The investigators do lifestyle counseling for PCOS patients and monitor the factors to normal level, like BMI, serum index etc.
16077015|NCT02331745|Drug|Granulocyte colony-stimulating factor|Granulocyte colony-stimulating factor(G-CSF) was given 5 ug/kg subcutaneously qd for 6 doses,then qod for other 6 doses(total 12 doses).
16077016|NCT02331745|Drug|standard treatment|Standard treatment includes reduced glutathione, glycyrrhizin, ademetionine,polyene phosphatidylcholine, alprostadil, and human serum albumin) on the day of admission. HBV associated ACLF patients receive entecavir at the same time
16077017|NCT02331732|Behavioral|Virtually Observed Treatment|
16077018|NCT02331732|Other|Directly Observed Treatment|
16077019|NCT02331706|Drug|Interferon alpha-2B (IFN-α) 3 million units (MU) subcutaneous daily|
16077020|NCT02331693|Biological|anti-EGFR CAR T|
16077021|NCT02331680|Drug|OPC-41061|
16077022|NCT02331680|Drug|OPC-41061|
16077023|NCT02331680|Drug|Placebo|
16077024|NCT02331667|Other|Seafood|The aim is to investigate the effect of meals consisting of mackrel and herring on learning abilities by using a two-armed individually randomized non-blinded intervention trial.
16077025|NCT02331667|Other|Non-seafood|The aim is to investigate the effect of meals consisting of meat on learning abilities by using a two-armed individually randomized non-blinded intervention trial.
16077026|NCT02331654|Other|Experimental treatment|Anodal DC stimulation (2 mA, 20 min) will be delivered by a constant direct current electrical stimulator connected to a pair of electrodes
16077027|NCT02331654|Other|Placebo treatment|Electrodes will be placed as for active stimulation, but the stimulator will automatically turn off after 10 s
16077028|NCT02331641|Procedure|Hepatectomy|Removal of a part of the liver
16077029|NCT02331628|Device|ESWT - Extracorporeal Shockwave Therapy|"Patients will receive:
~Four applications of EWST to be delivered to the affected hip and /or knee over a period of eight weeks : starting week 8\52 from baseline until and including week 14\52, one dose every two weeks ± 3 days), administered by the principal investigator.
~Dosage will be calculated for each participant, by the manufacturer, according to the size of NHO as recorded on X-ray.
~The energy flux density (EFD) will be 'high level'
~All participants will be supplied with headphones to reduce the noise level emitted by the machine."
16077030|NCT02331615|Device|neuroConn_CE_DC-STIMULATOR|right frontal anodal stimulation
16077031|NCT02331615|Device|neuroConn_CE_DC-STIMULATOR|left frontal anodal stimulation
16077032|NCT02331615|Device|SHAM|no meaningful stimulation will be given
16077033|NCT02331602|Drug|Rivaroxaban|Patients are assigned to receive rivaroxaban 15mg once daily for 12 months. Patients with creatinine clearance 30-49 mL/min receive rivaroxaban 10mg once daily.
16077034|NCT02331602|Drug|Dabigatran|Patients are assigned to receive dabigatran 150mg twice daily for 12 months. Patients at a high risk of bleeding receive dabigatran 110mg twice daily.
16077035|NCT02331589|Drug|KRG (Korea Red ginseng)|3 weeks of KRG capsule (3,000 mg/day)
16077036|NCT02331589|Drug|Placebo (for KRG)|Placebos with same shape and size were manufactured and at Korea Ginseng Corporation
16077037|NCT02331576|Drug|rocaine|
16077038|NCT02331576|Drug|Fentanyl|
16077039|NCT02331563|Drug|Dexmedetomidine|ultrasound guided transvers abdominis plane block
16077040|NCT02331563|Drug|0.25 % bupivacaine|ultrasound guided transvers abdominis plane block
16077041|NCT02331550|Procedure|Ablative treatment|Use of an ablative treatment (cryotherapy) for the management of Low-Grade Squamous Intraepithelial Lesions of the cervix.
16077042|NCT02331550|Procedure|Expectant management|Patients diagnosed with Low-Grade Squamous Intraepithelial Lesions were managed with observation and evaluation at 6 and 12 months after diagnosis.
16077043|NCT02331537|Behavioral|Internet-based cognitive-behavior therapy|Internet-based cognitive-behavior therapy on a safe internet platform. Treatment is divided into seven modules, each containing homework assignments . The participants will be assigned a therapist that they can contact through a message system in the platform and expect answer within 24 hours.
16077044|NCT02331524|Behavioral|Activity Feedback and Encouragement|"The Daily Activity Feedback/ Encouragement group will receive weekly feedback and encouragement regarding daily activity using the Fitbit Zip® for 3 months. Visual feedback and verbal encouragement will be provided. Visual feedback will provide graphics showing current and historical daily activity trends since the start of the intervention period. Subjects in the Feedback group will also receive standardized verbal feedback based upon the Fitbit Zip data. For example, subjects demonstrating a trend of increasing daily activity will be encouraged to Continue what you are doing. You are doing great!"
16077045|NCT02331524|Other|Health Coaching/Home Exercise|The Health Coaching/Home Exercise group will receive 12 weekly health coaching and physical therapy visits for 3 months. Health coaching will be provided by a trained, highly experienced health and wellness coach. In-home health coaching sessions will be provided monthly (total of 3) with the remaining 9 sessions provided telephonically. Initial health coaching sessions will include the utilization of motivational interviewing to establish individualized, three-month goals related to symptoms, function, and/or daily activity, with subsequent sessions celebrating successes in and/or identifying barriers to achieving these goals.
16077046|NCT02331511|Drug|placebo|placebo administration for 3 months after device(PPM,ICD,CRT) implantation
16077047|NCT02331511|Drug|Aspirin 80 mg daily|Aspirin 80 mg daily administration for 3 months after device(PPM,ICD,CRT) implantation
16077048|NCT02331511|Drug|Clopidogrel 75 mg daily|Clopidogrel administration for 3 months after device(PPM,ICD,CRT) implantation
16077049|NCT02331498|Drug|Pazopanib|Study drug Pazopanib will be administered once tumoral evaluation has been performed and after Stupp Protocol (TMZ + Radiation) realisation.
16077050|NCT02331485|Device|PICO + Acticoat group|Comparison between Pico and Acticoat dressing change after 3 and 7 days with standard Mepor dressing change on daily basis.
16077051|NCT02331459|Other|Multicomponent training intervention|"Intervention characteristics: 24weeks, 5days/week, 60min/session Day 1, 3 and 5 15 min (a) 40 min (b) 5 min (d) Day 2 and 4 15 min (a) 40 min (c) 5 min (d)
~Legend:
~min. =minutes a = Proprioception exercises, postural sway and dynamic balance, coordination and flexibility of the lumbo-pelvic area b = Aerobic training 65% maximal Heart rate c = Strength training arms and legs d = Stretching"
16077052|NCT02331459|Other|Nutritional intervention|"Enrolled patients will receive nutritional information on optimal daily energy intake, ensuring at least a daily protein intake of 1 g. of by kg of weight.
~Calcium plus vitamin D (total amount 1200 mg calcium plus 800 IU of vitamin D) Vitamin D will be provided if calcidiol (Cldl) blood levels are lower than 30 ng/ml.
~Cldl 20-29 ng/dl it will provide calciferol 20.000 IU every 15 days (3 months) Cldl 10-19 ng/dl it will provide calciferol 20.000 IU every 10 days (3 months) Cldl 1-9 ng/dl it will provide calciferol 20.000 IU every 7 days (3 months)"
16077053|NCT02331446|Behavioral|Physical exercise intervention|
16077054|NCT02331433|Drug|APN1125|APN1125 orally at ascending doses
16077055|NCT02331433|Drug|Placebo|Matching Placebo
16077056|NCT02331420|Procedure|Gastric bypass|A subcardial gastric pouch with a 30±10 ml capacity will be created by sectioning the stomach with a linear stapler 3-4 cm horizontally on the lesser curve, 4 cm distal to the e-g junction, and then vertically until attainment of the angle of Hiss. After identification of the Treitz ligament, the jejunum will be transected at 100 cm from the ligament of Treitz and the two stumps will be closed. The distal stump will be anastomosed to the distal end of the gastric pouch. The preferred gastro-jejunal anastomosis is the totally hand-sewn one, but it can be performed using any other the technique the surgeon is more familiar with. Finally, the proximal stump of the transacted bowel will be joined end-to-side to the jejunum 150 cm distal to the gastro-enterostomy.
16077134|NCT02330926|Other|home-based self-assisted exercise program|
16077135|NCT02330926|Drug|Ibuprofen|
16077136|NCT02330913|Procedure|Intracorporeal esophagojejunostomy|Under laparoscopic view, esophagojejunostomy was pereformed with 60mm linear stapler on right side of distal esophagus like as functional end-to-end fashion before esophageal and jejunal resection. Then, three procedures of esophageal resection, common entry hole closure and jejunal resection was performed with a single use of 60mm stapler. Also, jejunojejunostomy was also performed via already made staple entry hole.
16077057|NCT02331420|Behavioral|Medical therapy|"Assessment and treatment by a multidisciplinary team (diabetologist, dietitian, nurse);
~Planned visits at baseline and at 1, 3, 6, 9, 12, and 24 months after study entry;
~Oral hypoglycemic agents and insulin doses optimized on an individual basis with the aim of reaching a glycated hemoglobin level of less than 7%;
~Programs for diet and lifestyle modification, including reduced overall energy and fat intake (<30% total fat, <10% saturated fat, and high fiber content) and increased physical exercise (≥30 minutes of brisk walking every day, possibly associated with moderate-intensity aerobic activity twice a week);
~low-calorie diet (every day: 50% carbohydrate, 30% protein and 20% lipids)."
16077058|NCT02331407|Device|Robotic arm therapy|Training with the ReoGo device
16077059|NCT02331394|Dietary Supplement|Chinese herbs formula: Shu Yu Wan|The patients will be offered the choice of taking the CH formula in capsules or sachets and given instructions about recommendations to improve palatability. The formula should be taken with meals 3 times a day (each dose is either 1 sachet or 4 capsules) for six-weeks.
16077060|NCT02331381|Device|Magnetic resonance imaging|
16077061|NCT02331368|Procedure|Autologous Stem Cell Transplant|
16077062|NCT02331368|Drug|Melphalan|140-200 mg/m^2
16077063|NCT02331368|Drug|Lenalidomide|5-15 mg/day starting 45-90 days post-transplant
16077064|NCT02331368|Drug|MK-3475|200 mg/day every 3 weeks starting day +14 post-transplant for a total of 9 doses.
16077065|NCT02331342|Device|NICOM cardiac output measurement|
16077066|NCT02331342|Device|Innocor cardiac output measurement|
16077067|NCT02331329|Device|NICOM cardiac output measurement|
16077068|NCT02331329|Device|Cardiac MRT cardiac output measurement|
16077069|NCT02331316|Other|Daily extra water intake|"Intervention-A: Timing of assigned daily extra water intake specified
~Intervention-B: Daily extra water assigned at any time during 24 hour period"
16077070|NCT02331303|Other|Radium-223 dichloride (Xofigo, BAY88-8223)|Xofigo was approved in the US and EU for the following indication: Xofigo is indicated for the treatment of adults with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastases. Xofigo is contraindicated in women who are or may become pregnant.
16077071|NCT02331277|Drug|BI 655064|subcutaneous injection
16077072|NCT02331277|Drug|Placebo|Placebo
16077073|NCT02331264|Other|Exposure to metal debris|The 3 groups are defined by the patients exposure to metal debris from a hip implant. This is either elevated metal ions in those with poorly functioning metal on metal hip implants, or low metal ion levels in those with well functioning metal hip implants, and a second control group of patients with non melt bearing hip implants.
16077074|NCT02331251|Drug|Pembrolizumab|
16077075|NCT02331251|Drug|Gemcitabine|
16077076|NCT02331251|Drug|Docetaxel|
16077077|NCT02331251|Drug|Nab-paclitaxel|
16077078|NCT02331251|Drug|Vinorelbine|
16077079|NCT02331251|Drug|Irinotecan|
16077080|NCT02331251|Drug|Liposomal Doxorubicin|
16077081|NCT02331238|Behavioral|"Coaching Boys into Men program"|"Coaching Boys into Men program consists of 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rational for Coaching Boys into Men and the Coaching Boys into Men Coaches Kit. The coaches use this Coaching Boys into Men toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth."
16077082|NCT02331225|Other|No intervention given|There is no intervention for this study
16077083|NCT02331212|Other|Cytology Specimen Collection Procedure|Correlative studies
16077084|NCT02331212|Other|Laboratory Biomarker Analysis|Correlative studies
16077085|NCT02331199|Device|Amniotic fluid lamellar body count|The LBC (the unit of measurement is number of lamellar bodies counted per microliter of amniotic fluid) will be determined using the platelet channels on the Hematology Flow Cytometer.
16077086|NCT02331199|Device|Fetal pulmonary artery Doppler|A fetal pulmonary artery Doppler will be performed using color Doppler ultrasound. Doppler flow velocity measurements, including systolic/diastolic ratio, pulsatility index, resistance index, and acceleration-time/ejection-time ratio using spectral Doppler ultrasound.
16077087|NCT02331186|Procedure|bariatric surgery|bariatric surgery for obese women
16077088|NCT02331173|Drug|Dorzolamide 2% TID or brinzolamide 1% TID|"Dosing of all medications will be based upon standard of care. Standard dosing for the treatment of pediatric and adult patients with XLRS is as follows:
~Topical dorzolamide 2% three times per day
~Topical brinzolamide 1% three times per day"
16077089|NCT02331160|Behavioral|Rebozo|Shaking of the maternal pelvis by the midwife to increase the spontaneous cephalic version rate in breech presentation.
16077090|NCT02331147|Other|Offloading|Patient will be offloaded in a diabetic camboot after treatment
16077091|NCT02331147|Other|Dressing Application|Application of a non-adherent dressing, a moisture retentive dressing, and a multi-layer compression dressing.
16077092|NCT02331134|Drug|Filgrastim|Patients will receive 10 μg/kg/day of filgrastim subcutaneously in a 4-day mobilization schedule
16077093|NCT02331121|Behavioral|Family First Aid Online Training|Web-based interactive multimedia program comprised of videos, interactive animations and text information designed to teach parents of children aged birth to 12 years old basic first-aid and CPR skills, including the option to practice skills as needed.
16077094|NCT02331121|Behavioral|Text-only Online Training|Online text created from the American Heart Association's 2010 guidelines for CPR training via a computer, depicting infant, child and adult CPR skills and choking relief.
16077095|NCT02331108|Drug|Selection of anesthetic induction technique|Standard anesthesia care will be provided after induction based on randomization. Temperatures will be monitored every 15 minutes
16077096|NCT02331095|Drug|Atorvastatin|"Atorvastatin belongs to the statin class of drugs, and is routinely used for prevention of cardiovascular diseases and/or reduction of cholesterol levels. It has been shown to decrease the risk of first venous thromboembolism in an otherwise healthy population with elevated high-sensitivity C-reactive protein (hs-CRP)."
16077097|NCT02331095|Drug|Anticoagulation Therapy|Warfarin is a standard anticoagulation in the treatment for venous thromboembolism. The dose will be adjusted to goal INR of 2-3.
16077137|NCT02330900|Other|Study group|Exposure to cell phone interference of the ICD
16077098|NCT02331082|Other|Structured Quality Improvement|For structured quality improvement, trained healthcare providers (primarily doctors from referral hospital) will serve as mentors to mid-level providers. The mentors will facilitate on-site trainings of primary care with mid-level providers at the district hospital. Mentors will also travel monthly to the healthcare facilities themselves to provide training both in the direct context of clinical care and to provide feedback based upon surveillance and monitoring data. The focus will be on the techniques from the Institute for Healthcare Improvement's Model for Improvement, including Plan-Do-Study-Act cycles, run charts, and root cause analyses. Finally, they will work with the clinical healthcare staff to identify resource needs from the local government for maintenance, water, electricity, and supplies. These resource needs will be addressed through an integrated supply chain management system across the tiers of the healthcare system.
16077099|NCT02331082|Other|Chronic Care Model|Senior physicians trained in mentorship of non-physician mid-level providers will provide decision support for mid-level providers in the current district healthcare system with specific protocols for target conditions. We will add the following elements: focus on mid-level, non-physician providers as the primary clinicians within the intervention; intensive Community Health Worker (CHW) outreach for detection, screening, follow-up of patients, and encouragement of patient self-care and behavior change; and focused effort on the seamless care coordination of patients across the tiers of the system. Through trainings of CHWs, much of patient self-management comes in the form of home visits that reinforce clinic and hospital counseling, including risk management and prevention. CHWs will be trained in the counseling of each target condition, with counseling largely occurring in the patients' homes, where much of the challenges of chronic disease management and behavior change lie.
16077100|NCT02331082|Device|Integrated Electronic Medical Record|Clinical information systems. We are developing a system for tracking patients that integrates across each of the tiers using an electronic medical record. This is a key technology in supporting each of the above delivery system design elements.
16077101|NCT02331082|Device|Solar-powered electrical supply|As a component of our comprehensive healthcare systems strengthening intervention, we are installing solar panels at community-level clinics to ensure continuous electrical supply for medical devices and technology.
16077102|NCT02331082|Behavioral|Performance-based financing|As part of our healthcare systems strengthening intervention, we have established a performance-based financing agreement with the Government of Nepal that conditionally funds healthcare delivery based on population-level health outcomes and quality healthcare service delivery. In this arrangement, the Government serves as a regulator of healthcare delivery rather than a primary provider of healthcare services.
16077103|NCT02331082|Other|Existing healthcare system|This is the current rural, district-level public sector healthcare infrastructure of rural Nepal that is not strengthened during the study.
16077104|NCT02331069|Drug|Dextrose 5% (D5W)|0,1,2, and 3 week injection sessions consisting of injection of 2 ml of D5W into the D-T groove at the point of maximal pain at 1-2 cm depth, followed by subcutaneous injection of D5W at 4 cm intervals along the course of the PACN if tenderness is present.
16077105|NCT02331069|Other|Physical therapy|Three times weekly X 3 week sessions to include myofascial release, exercise, and one modality.
16077106|NCT02331056|Other|fluid loading|"Fluid loading at defined period
~500ml colloid solution infusion at 20min after thorax open for 30min. 500ml colloid administration is a kind of routine procedure during pulmonary lobectomy in our hospital. We just control the fluid loading timing for hemodynamic parameter records."
16077107|NCT02331056|Procedure|thoracoscopic pulmonary lobectomy|the patient group for scheduled thoracoscopic pulmonary lobectomy
16077108|NCT02331056|Procedure|thoracotomy|the patient group for scheduled open pulmonary lobectomy
16077109|NCT02331043|Dietary Supplement|Plant stanol ester|
16077110|NCT02331043|Dietary Supplement|Placebo|
16077111|NCT02331030|Procedure|Supraclavicular|Ultrasound-guided supraclavicular brachial plexus block
16077112|NCT02331030|Procedure|Pecs II block|Ultrasound guided interfascial plane block between pectoralis minor and serratus anterior
16077113|NCT02331030|Procedure|Sham block (Grade 1)|Sham block -- with skin preparation, ultrasound scanning of pecs II block area, but no actual needle injection
16077114|NCT02331030|Drug|Ropivacaine 0.5% 20ml|Local anaesthetic solution administered for supraclavicular block
16077115|NCT02331030|Drug|Ropivacaine 0.5% 10ml|Local anaesthetic solution administered for pecs II block
16077116|NCT02331017|Behavioral|Speech perception tests and self-rating questionnaire|Speech perception test results and self-rating questionnaire scores will be analyzed by means of non-parametric statistical tests. The statistical tests will be chosen in accordance with the number and type of variables in each test. Correlation between audiological variables (aided and unaided hearing thresholds in the non implanted ear, aided speech perception abilities in the HA-alone condition) and the bilateral-bimodal benefit will be examined. Moreover, possible relationship between self-rating questionnaire scores and speech perception test results will be assessed.
16077117|NCT02331004|Other|Intervention for fine motor skills|Implementation of an well known activity to improve the function of upper extremities
16077118|NCT02331004|Other|Support to activities of daily living|Participants are supported and orientated when they are performing some activity of daily living scheduled by the institution
16077119|NCT02330991|Drug|Temozolomide|
16077120|NCT02330978|Procedure|Intravitreal transplantation of mesenchymal stem cell|
16077121|NCT02330978|Biological|Culture and isolation of autologous bone-marrow mesenchymal stem cells|
16077122|NCT02330965|Procedure|Blood Draw|Blood draws (65 mLs [~4 tablespoons] per blood draw) at 4 time points: Prior to study medication initiation, and at +6, +12 and+24 months post treatment initiation.
16077123|NCT02330965|Procedure|CSF collection by lumbar puncture (Optional)|For participants who volunteer to donate CSF samples: up to 25 mLs (<2 tablespoons): prior to study medication initiation, and at month 24 post treatment initiation.
16077124|NCT02330952|Drug|Prednisone|40mg/day per os for 5 days
16077125|NCT02330952|Drug|Placebo|40mg/day per os for 5 days
16077126|NCT02330939|Other|Low fat- Low glycemic index meal|
16077127|NCT02330939|Other|MUFA- Low glycemic index meal|
16077128|NCT02330939|Other|SAFA- Low glycemic index meal|
16077129|NCT02330939|Other|Low fat- High glycemic index meal|
16077130|NCT02330939|Other|MUFA- High glycemic index meal|
16077131|NCT02330939|Other|SAFA- High glycemic index meal|
16077138|NCT02330887|Other|Group Antenatal Care|The group antenatal care intervention will match pregnant women by gestational age in the intervention village clusters and assign them to peer group sessions facilitated by local healthcare clinic staff.
16077139|NCT02330887|Other|Individual Antenatal Care|Pregnant women in control village clusters will have individual antenatal care sessions with their healthcare provider.
16077140|NCT02330861|Device|combowire and IVUS|
16077141|NCT02330848|Dietary Supplement|Walnut Ad libitum diet|Participants will be provided 392 grams of walnuts per week (56g or 2 oz/day) to include in their diet. Their calorie intake will not be subsequently monitored or regulated, and thus will be allowed to float ad libitum
16077142|NCT02330848|Dietary Supplement|Walnut Calorie controlled|The intervention group participants will meet with a registered dietitian and receive instructions and recipes for inclusion of 392 grams of walnuts per week (56g or 2 oz/day) in their meal plan for 6 months.
16077143|NCT02330835|Behavioral|In the Drivers Seat|Multimedia student behavior management program for school bus drivers and school administrators
16077144|NCT02330835|Behavioral|School bus driver training videos|Basic bus driving safety videos
16077145|NCT02330822|Drug|Hyaluronic Acid|This material is going to be injected into the extraction socket in order to promote bone healing.
16077146|NCT02330809|Other|Daily extra water intake|Amount of extra daily water intake to consume
16077147|NCT02330809|Other|Timing of daily extra water intake|Intervention-A: Timing of daily extra water intake specified Intervention-B: at any time during 24 hour period
16077148|NCT02330796|Drug|Bucillamine|Bucillamine Tablets
16077149|NCT02330796|Drug|Colchicine|
16077150|NCT02330783|Drug|Bevacizumab|5mg/kg by intravenous (IV) infusion every two weeks of each 4-week cycle (dose was based on patient's weight at screening and remained the same throughout study)
16077151|NCT02330783|Drug|Sorafenib|400mg twice daily by oral of each 4-week cycle
16077152|NCT02330770|Drug|GnRHa and HCG|Final oocyte maturation will be triggered by dual administration of 0.2 mg of GnRHa preparation (Triptorelin) SC and 1500 IU of HCG preparation IM
16077153|NCT02330770|Drug|GnRHa then HCG (single low-dose)|Final oocyte maturation will be triggered by administration of 0.2 mg Triptorelin SC then a single IM bolus of 1500 IU HCG will be administered 35-37 hours after GnRHa trigger (1 hour after oocyte retrieval)
16077154|NCT02330770|Drug|GnRHa then HCG (multiple low-doses)|Final oocyte maturation will be triggered by administration of 0.2 mg Triptorelin SC then 3 IM boluses of 500 IU HCG will be administered day 1, day 4 and day 7 after oocyte retrieval
16077155|NCT02330757|Drug|Estradiol valerate|Women will be given estradiol valerate 4 mg daily from day 2 to day 12 of the cycle then the endometrial thickness will be assessed on day 13 by transvaginal sonography (TVS). If the endometrium is ≥ 8 mm and of moderate echogenicity, luteal phase support (using progesterone supplements) will be started but if the endometrium is < 8 mm, estradiol valerate will be continued until reaching appropriate endometrial thickness and echogenicity then the luteal phase support will be started.
16077156|NCT02330757|Drug|Sequential Clomiphene citrate and Gonadotropin|Women will be given clomiphene citrate in dose of 100-150 mg daily for 5 days (from day 2 to day 6 of the cycle) then switched to low dose gonadotropin (75-150 IU daily) followed by monitoring of the follicular growth (folliculometry) ); starting from day 10 of the stimulation cycle and repeated every 2 days. Final oocyte maturation will be induced by administration of human chorionic gonadotropin (HCG) when there will be at least one leading follicle > 18 mm in diameter followed by luteal phase support (using progesterone supplements) after 48 hours.
16077157|NCT02330744|Behavioral|Approach-positive AAT|One session of approach-positive AAT (Aim 1 and 2) followed by 4 sessions of approach-positive AAT over 2 weeks concurrent with a brief computer-delivered behavioral activation treatment for depression (Aim 3).
16077158|NCT02330744|Behavioral|Control AAT|One session of control-AAT (Aim 1 and 2) followed by 4 sessions of control-AAT over 2 weeks concurrent with a brief computer-delivered behavioral activation treatment for depression (Aim 3).
16077159|NCT02330731|Procedure|injection sclerotherapy for gastric varices|The intravariceal technique of injection
16077160|NCT02330718|Other|No intervention|
16077161|NCT02330705|Drug|HCG|Women will be given HCG before IUI
16077162|NCT02330692|Other|No intervention|
16077163|NCT02330679|Drug|Desvenlafaxine|The intervention will consist of a 2-week single-blind placebo run-in phase followed by a 12-week open-label trial with desvenlafaxine (a SNRI medication)
16077164|NCT02330679|Drug|Placebo|
16077165|NCT02330666|Behavioral|Mission Possible: Parents & Kids Who Listen|MP is a 12-hour, 6-session, manualized skills training program with 2 boosters. Behavioral strategies teach adults and youth to communicate with one another emphasizing youth's need for flexible family boundaries, emotional closeness, and adults as resources. Dyads attend together. Sessions begin with relaxation exercises, review of the prior week's lessons and homework, and examination of success and failure in trying communication techniques. New concepts are introduced using didactic videotaped presentations. Lively, interactive, developmentally appropriate group exercises follow reflective of ethnic diversity that are reinforced with handouts and encouragement to try them at home. Week-by-week content covers: Developmental Changes; Self-Esteem; Communicating What You Want; Listening to What the Other Wants; Solving Conflicts; and Letting Go. The booster sessions are 2 hours in length and update developmental concepts; 5 basic listening skills; and 6 conflict resolution steps.
16077166|NCT02330653|Biological|Fecal Microbiota Transplant (FMT)|The study intervention consists of frozen, bottled or encapsulated fecal microbiota preparations that have been screened and prepared to a uniform and rigorous standard by OpenBiome. FMT is performed by patients receiving a retention enema and swallowing capsules, introducing stool from a healthy donor into their intestinal tract.
16077167|NCT02330653|Biological|Placebo|Placebo administration will consist of both a placebo retention enema and placebo capsules.
16077168|NCT02330640|Drug|ticagrelor|After the operation, the subjects will be randomized into two groups according to the proportion of 1:1; and receive the treatment of aspirin 100mg qd+ticagrelor 90mg bid or the treatment of aspirin 100mg qd+ clopidogrel 75mg qd. The study will plan to enroll 140 subjects in 12 months and the treatment will last for 30 days.
16077169|NCT02330640|Drug|clopidogrel|After the operation, the subjects will be randomized into two groups according to the proportion of 1:1; and receive the treatment of aspirin 100mg qd+ticagrelor 90mg bid or the treatment of aspirin 100mg qd+ clopidogrel 75mg qd. The study will plan to enroll 140 subjects in 12 months and the treatment will last for 30 days.
16077170|NCT02330640|Drug|asprin|All patients will be given asprin 100mg Qd within 24hours after operation,and will continue taking aspirin at the end of the study
16077171|NCT02330627|Behavioral|Positive Valence System Treatment|Clinician-administered one-hour treatment sessions focused on presenting rationale and instructions for completing positive activity exercises (e.g., gratitude, acts of kindness) between sessions.
16077172|NCT02330614|Other|Bleaching by peroxide carbamide 10%|bleaching were treated with 10% carbamide peroxide (CP) gel (Whiteness Perfect, FGM) to each subject With verbal instructions for 3 weeks with daily applications of 1 hour according to manufacturers indications
16077173|NCT02330614|Other|Nothing - control group|Only NEO-FFI test , data used as control
16077174|NCT02330601|Procedure|endoscopic papillary large balloon dilation|For the patients in EPLBD group, a CRE balloon (diameter 10, 11, 12, 13.5, 15 mm; Boston Scientific) was chosen according to the diameter of bile duct. It was placed across the papilla orifice and then gradually filled with diluted contrast. When the waist disappeared, the balloon was kept inflated for 120s. The stones were then retrieved by a basket or a retrieval balloon.Mechanical lithotripsy was used if necessary
16077175|NCT02330588|Behavioral|Eat It|"The SBIRT (Screening, Brief Intervention, Referral to Treatment), called RIPPLE (Resource Information Program for Parents on Lifestyle Education) was delivered on a study-designated tablet and designed to (1) screen children's weight status, (2) deliver a brief intervention*, and (3) provide parents with the opportunity select resources and services to help prevent obesity in children.
~*Two brief questions about children's grain portion sizes and sugar sweetened beverage intake were presented."
16077176|NCT02330588|Behavioral|Move It|"The SBIRT (Screening, Brief Intervention, Referral to Treatment), called RIPPLE (Resource Information Program for Parents on Lifestyle Education) was delivered on a study-designated tablet and designed to (1) screen children's weight status, (2) deliver a brief intervention*, and (3) provide parents with the opportunity select resources and services to help prevent obesity in children.
~*Two brief questions about children's moderate-to-vigorous physical activity (MVPA) and screen time were presented."
16077177|NCT02330588|Behavioral|eHealth Control|The eHealth Control group (1) screened children's weight status, and (2) provided parents with the opportunity select resources and services to help prevent obesity in children.
16077178|NCT02330575|Behavioral|Exercise|The participant exercise sessions will be conducted in small groups of 5 to 10 participants under the direct supervision of the community-based exercise specialist. Participants will have the choice between taking part in a bridging exercise class (e.g., Beauty program and Bridging to Fitness - Cancer) or group-based supervised fitness centre exercise training.
16077179|NCT02330575|Behavioral|Education|Participants allocated to the standard care group will receive standard advice and counseling on physical activity and will serve as the 'control group' for a 16-week period.
16077180|NCT02330562|Drug|MRZ|"MRZ dosing in Phase 1 to range from 0.55 to 0.8 mg/m2. Dose Escalation: MRZ dose-escalation will occur using a standard 3+3 study design.
~The RP2D of MRZ (0.8.mg/m2) will be used in a two stage design, with fifteen response-evaluable patients entered in the first stage. If 1 or more responses are observed at the MRZ RP2D, then the second stage will be implemented with an additional 15 response-evaluable patients treated."
16077181|NCT02330562|Drug|BEV|BEV 10 mg/kg IV infusion administered for all cohorts in Phase 1 only.
16077182|NCT02330549|Drug|Cenicriviroc 150 mg|Cenicriviroc (CVC) 150 mg, administered orally once daily and taken every morning with food.
16077183|NCT02330549|Drug|Placebo|Placebo-matching CVC administered orally once daily and taken every morning with food.
16077184|NCT02330536|Device|Insufflation of carbon dioxide (CO2)|After patients were positioned, CO2 was insufflated into right pleural cavity at eight or twenty L/min. during video-assisted thoracoscopic surgery, thoracic pressure, hemodynamic and respiratory parameters were recorded.
16077185|NCT02330523|Device|allograft + x-link collagen membrane|Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Allograft will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. X-link collagen membrane will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0.
16077186|NCT02330523|Device|xenograft + non-x-link collagen|Following resolution of any periodontal issues in the region of study and administration of pre-surgical antibiotic, minimally traumatic extraction with periotomes and flap reflection will be performed. Xenograft will be placed according to randomization schedule and in quantity to fill the extraction socket and mimic surrounding ridge dimension. Non-x-link collagen membrane will be trimmed to extend at least 2 mm beyond the margins of the defect, and soft tissue flaps will be re-approximated using resorbable Vicryl® 6-0.
16077187|NCT02330497|Procedure|Radiofrequency Ablation under EUS|Pancreatic radiofrequency ablation under endoscopic ultrasonography guidance Procedure under general anesthesia Punction of the pancreatic lesion and aspiration of the liquid if present / then thermal ablation with a 18G needle (50 W during 10 secondes) - only one session
16077188|NCT02330484|Behavioral|Give incentives to patients based on their own HbA1c improvement|Give incentives to patients based on their own HbA1c improvement
16077189|NCT02330484|Behavioral|Give incentives to physician based on their patient's HbA1c improvement|Give incentives to physician based on their patient's HbA1c improvement
16077190|NCT02330471|Procedure|Spray|surgical method to achieve intraoperative hemostasis by a superficial electrocoagulation of 80 Watt voltage
16077191|NCT02330471|Procedure|Forced|surgical method to achieve intraoperative hemostasis by a deep tissue electrocoagulation of 80 Watt voltage
16077192|NCT02330458|Procedure|Small bowel ultrasound|Small Bowel Ultrasound will be performed by a single radiologist using an Acuson S2000 machine with 6 MHz convex and 9 MHz linear array transducers (Siemens, Germany). Participants will be asked to not eat for at least 8 hours prior to the ultrasound, and to drink 500ml of a fluid of their choice just prior to the SBUS, for bowel distension and better visualization. Bowel wall thickness (BWT), the length of any segment of thickened bowel wall >3mm, hyperemia using doppler, and the presence of free fluid, stricture, intestinal dilation, or enlarged lymph nodes will be documented
16077193|NCT02330445|Drug|PRTX-100|6 micrograms PRTX-100 per kilogram of body weight administered via infusion
16077194|NCT02330432|Biological|Mycobacterium w|Single daily dose of 0.3 mL of Mw (heat-inactivated Mw [0.5 × 10^9]; Immuvac, Cadila Pharma, Ahmedabad, India) in the deltoid region for 3 consecutive days
16077195|NCT02330432|Other|Best standard care|Antibiotics as early as possible; Norepinephrine > vasopressin > epinephrine for hypotension; Blood glucose 140-180 mg/dL; DVT and stress ulcer prophylaxis; Low tidal volume mechanical ventilation; Standard VAP, CLABSI prevention bundles
16077196|NCT02330419|Drug|Placebo|
16077197|NCT02330419|Drug|Naltrexone|
16077198|NCT02330406|Drug|Anagliptin|Suiny 100 mg
16077199|NCT02330406|Drug|Sitagliptin|Januvia 50 mg Glactiv 50 mg
16077200|NCT02330380|Drug|Methotrexate|"Subjects will receive Methotrexate as detailed in the Group description."
16077201|NCT02330380|Drug|Ustekinumab|"Subjects will receive Ustekinumab as detailed in the Group description."
16077202|NCT02330380|Drug|Etanercept|"Subjects will receive Etanercept as detailed in the Group description."
16077203|NCT02330380|Drug|Adalimumab|"Subjects will receive Adalimumab as detailed in the Group description."
16077204|NCT02330380|Drug|Acitretin|"Subjects will receive Acitretin as detailed in the Group description."
16077205|NCT02330380|Other|UVB Excimer Laser|"Subjects will receive UVB Excimer Laser therapy as detailed in the Group description."
16077206|NCT02330380|Other|Narrowband UVB|"Subjects will receive Narrowband UVB as detailed in the Group description."
16077207|NCT02330367|Drug|AC0010|"Phase 1: AC0010 will be administered in escalating dosages in a period of 28-day cycles.
~Phase 2: AC0010 will be administered twice-daily at RP2D."
16077208|NCT02330354|Behavioral|Healthy Me, Healthy We|The intervention - Healthy Me, Healthy We - is a 7-month social marketing campaign designed to improve preschool children's (3-4 years) diet and physical activity behaviors.
16077209|NCT02330341|Dietary Supplement|Artemisia dracunculus|
16077210|NCT02330341|Other|Placebo|
16077211|NCT02330328|Other|No Telemetry Monitoring|
16077212|NCT02330328|Device|Telemetry Monitoring|
16077213|NCT02330315|Device|transcranial direct current stimulation (tDCS)|Subjects will receive 20 minutes of either active or sham tDCS at intensity of 2mA. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. In the sham group, the tDCS device will not be active for the full 20 minutes.
16077214|NCT02330315|Device|transcranial ultrasound (TUS)|Subjects will receive 20 minutes of either active or sham TUS. During active stimulation the ultrasound will be active for the full 20 minutes- however, during sham stimulation the ultrasound will not be active for the full 20 minutes.
16077215|NCT02330302|Drug|Ropivacaine|Ultrasound-guided femoral nerve block with Ropivacaine 0.5% 30mls
16077216|NCT02330302|Drug|Ropivacaine|Ultrasound-guided suprainguinal approach to fascia iliaca block with Ropivacaine 0.5% 30mls
16077217|NCT02330289|Behavioral|Normative report card|Personalized visual report card describing physician's laboratory ordering pattern for prior week relative to peers as well as a link to a website tracking lab ordering for the team in real time compared to peer teams.
16077218|NCT02330276|Drug|(+)-Epicatechin|The drug to be tested is (+)-epicatechin, synthesized under GMP standards. Subjects will be given a single oral dose of (+)- epicatechin and followed on an inpatient basis over 24 hours. Three (3) different dose levels will be tested in a randomized, double-blind design: (+)- epicatechin 10 mg, 30 mg, or 100 mg. As this is a pilot study, a placebo arm will not be included.
16077219|NCT02330263|Dietary Supplement|carbohydrate beverage|400ml of 12.8 g/100 ml carbohydrate beverage
16077220|NCT02330250|Other|Pharmaceutical Care|"The patients assigned for the intervention group will receive guidance from a pharmacist (pharmaceutical consultation) in addition to the medical care habitually delivered by the hospital.
~The pharmacist will review the drug therapy, identifying current and potential problems related to the drug prescription, making a systematic assessment of the need, effectiveness and safety of all medications and their adequacy to the patient's life routine. A care plan will then be designed along with the patient that may include interventions and/or referral to other practitioners."
16077221|NCT02330250|Other|Control|The patients assigned to the control group will receive the medical care habitually provided by the hospital and will be attended by a non-pharmacist professional, who will provide hygiene/nutritional counseling and risk reduction, such as smoking cessation advice; use of estrogen-based contraceptive drugs; exposure to sunlight, proper use of sunscreen and clothes; nutritional guidance on the intake of low saturated-fat food. As usual, information about the use of medication will be provided by the attending physician.
16077222|NCT02330237|Drug|natural gels|whole fruits and vegetables
16077223|NCT02330237|Drug|Placebo|
16077224|NCT02330224|Other|Hypertension Management Intervention|"The multifaceted intervention consists of three main components:
~Structured treatment algorithm with fixed dose antihypertensives for high cardiovascular disease risk patients
~Motivational conversation by nurses and nurse practitioners for high risk patients at baseline
~Telephone based follow-up for all patients by nurses"
16077225|NCT02330185|Device|ultrasonography|spinal anesthesia guided with ultrasonography
16077226|NCT02330172|Other|Injection of neostigmine or sugammadex|"At anesthetic induction, rocuronium 0.45 to rocuronium 0.45 - neostigmine group or rocuronium 0.9 mg/kg to rocuronium 0.9 - sugammadex group will be injected for muscle relaxation.
~During surgical procedure, we will monitor train of four (TOF) using nerve stimulator. After operation, neostigmine 50 mcg/kg or sugammadex 4 mg/kgl be injected."
16077227|NCT02330159|Procedure|Novel Wound Healing Protocol|All patients will undergo surgical excision of the pilonidal disease and application of the novel wound healing protocol. After excision, MatriStem MicroMatrix powder will be applied to the wound bed. A MatriStem Multilayer Wound Matrix sheet will then be placed over the MatriStem MicroMatrix, secured in place, then covered with surface dressings. The wound should be left undisturbed for 10-14 days (until the 1st follow-up visit). At the 1st postoperative visit, the wound will reassessed, and a second application of the MicroMatrix to the wound bed may be performed. At subsequent follow-up visits at 1, 3, and 6 months, the wound bed will be measured, photo documentation will be captured, and patients will complete a survey to assess quality of life.
16077228|NCT02330146|Drug|RCT-01|
16077229|NCT02330146|Drug|Placebo|
16077230|NCT02330133|Behavioral|Women's Reproductive Health|Targeted text and video information on website for women aged 25-55 to avoid unplanned pregnancy and sexually transmitted infections
16077231|NCT02330133|Behavioral|Online sexual health content|Online general text-based information about reproductive health issues and strategies for preventing sexually transmitted infections
16077234|NCT02330107|Other|MAT & LAT|"For MAT, the magnetic pellets will have ~200 gauss/pellet magnetic flux densities on average, with a diameter of 1.76 mm, to be put on the 6 selected acupoints of the ear.
~For LAT, a laser device (Pointer Pulse™) will be used in this study. This device has a wavelength of 650 nm, an average output power of 2.5 mW, an energy density of 1 minute with 0.54 J/cm2, and a pulse of 10 Hz. A 1-minute treatment using the continuous mode of the device will be directly applied to the reactive region of each of the six selected acupoints on the ear."
16077235|NCT02330094|Drug|Gabapentin|"Gabapentin capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.
~Both groups will receive other standard of care pain medications."
16077236|NCT02330094|Drug|Placebo|"Placebo capsules will be administered orally and titrated from 100 mg - 900 mg TID based on the patient's numeric pain score and creatinine clearance.
~Both groups will receive other standard of care pain medications."
16077237|NCT02330081|Device|Mirasol treatment of whole blood|"Subject will be infused with two products at the same time:
~radio-labeled platelets derived from subject's stored whole blood which has been treated with Mirasol.
~radio-labeled platelets derived from subject's untreated fresh whole blood."
16077238|NCT02330068|Drug|citalopram|Cases
16077239|NCT02330055|Procedure|Forty-five degrees elevated upper body position|
16077240|NCT02330055|Procedure|non-elevated upper body position|
16077241|NCT02330055|Device|Noninvasive wrist pulse oximeter (WristOx Model 3150)|The noninvasive wrist pulse oximeter (WristOx Model 3150) is used to measure the SpO2 and the pulse rate of the patient in the first night after delivery.
16077242|NCT02330055|Other|Stop-Bang questionnaire|"The Stop-Bang questionnaire is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient. The STOP Bang questionnaire includes snoring, tiredness, observed apneas, blood pressure, Body Mass Index, age, neck circumference and gender.
~The investigators will ask the patient to answer the questionnaire and measure the neck circumference."
16077243|NCT02330055|Other|Epworth Sleepiness Scale|"The Epworth Sleepiness Scale is a well-established clinical tool to quantify daytime sleepiness. It is clinically used for the diagnosis of sleep disorders.
~The investigators will ask the patient to complete the questionnaire and will specify that the questionnaire pertains to the patient's pre-admission condition."
16077244|NCT02330055|Other|P-SAP Score|"The P-SAP Score is a well-established clinical tool to quantify the risk factors of Obstructive Sleep Apnea, which can lead to desaturation in the patient.
~The investigators will ask the patient to answer the questionnaire and will assess the Mallampati Score. The investigators will also measure the neck circumference and the Thyromental distance."
16077245|NCT02330055|Other|self-reported pain|A verbal numerical rating scale is used to asses the pain during the study-night.
16077246|NCT02330029|Drug|Pinaverium|To test the effectiveness and safety of the formula for pain and diarrhea, we will randomly assign patients into one 3 groups: Pinaverium, TCM (Formula for pain and diarrhea) group, and placebo group, and treat them accordingly.
16077247|NCT02330029|Device|Atractylodes|Atractylodes (~10-15g)
16077248|NCT02330029|Device|Paeonia Lactiflora|Paeonia Lactiflora (~15-30g)
16077249|NCT02330029|Device|Tangerine Peel|Tangerine Peel (~10g)
16077250|NCT02330029|Drug|Ledebouriella Root|Ledebouriella Root (~10g)
16077251|NCT02330029|Drug|Radix codonopsitis|Radix codonopsitis (~10-15g)
16077252|NCT02330029|Drug|Radix curcumae|Radix curcumae (~10g)
16077253|NCT02330029|Drug|Fingered citron|Fingered citron (~10g)
16077254|NCT02330029|Drug|Tuckahoe|Tuckahoe (15g)
16077255|NCT02330029|Drug|Placebo|Placebo is blindly given to patients.
16077256|NCT02330016|Device|Voluma XC|Voluma XC
16077257|NCT02330003|Biological|IL-YANG FLU Vaccine Prefilled Syringe INJ.|Second vaccination (only for the test group) of IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL
16077258|NCT02330003|Biological|Fluarix Prefilled Syringe|Fluarix Prefilled Syringe 0.5mL
16077259|NCT02329990|Dietary Supplement|phosphorus|phosphorus supplement
16077260|NCT02329977|Other|standard barium meal examination|All eligible patients received standard barium meal examination, MRCP and enhanced abdominal CT.
16077261|NCT02329964|Drug|Sugammadex|Sugammadex 2mg/kg was injected to patients to R-S group, as reversal of neuromuscular blockade.
16077262|NCT02329964|Drug|Neostigmine|Neostigmine (pyridostigmine) 0.2 mg/kg mg was injected to patients to S-C-N group, as reversal of neuromuscular blockade.
16077263|NCT02329951|Procedure|Facet intervention|Diagnostic block of the nerves innervation the lumbar facet joint. If this block is positive (greater or equal to 50% relief), the participant will proceed to radiofrequency nerve ablation when the pain returns
16077264|NCT02329951|Procedure|Sacroiliac joint injection|Injection of steroid and local anesthetic into SI joint
16077265|NCT02329951|Procedure|Epidural steroid injection|Transforaminal or interlaminar injection of steroid epidurally
16077266|NCT02329938|Procedure|Lichtenstein tension free reair|a mesh is apllied on the posterior wall of the inguinal canal and sutured to the inguinal ligament below, to the internal oblique muscle above , and to rectus sheath medially.
16077267|NCT02329938|Procedure|Desarda's repair|the repair is done using a flap of the external oblique aponeurosis sutured to the inguinal ligament below and to the aponeurotic part of the internal oblique muscle above.
16077268|NCT02329925|Device|Tongue Stabilizing Device (TSD)|Tongue Stabilizing Device (TSD) is a preformed appliance for OSA that protrudes the tongue and improves upper airway structure and function during sleep.
16077269|NCT02329912|Device|SmartPill|Application of the SmartPill at the end of surgery
16077270|NCT02329899|Other|Second step of investigations|"Second step according to results of the first step:
~exploration of coagulation factors;
~factor XIII and fibrinolysis investigations;
~investigation of platelet function;
~investigation of thrombocytopenia."
16077271|NCT02329873|Behavioral|Respiratory rehabilitation exercise training|The respiratory rehabilitation exercise training package was conducted twice a day and 10-30 minutes per session for 4 days: (a) disease awareness, (b) sputum clearance treatments, (c) pursed lip breathing training, (d) upper-limb exercise with breathing pranayama, (e) walking training with breathing pranayama, and (f) assign a pulmonary rehabilitation program coordinator.
16077272|NCT02329860|Drug|Apatinib|
16077273|NCT02329860|Drug|Placebo|
16077411|NCT02328755|Procedure|Hematopoietic Cell Transplant (HCT)|
16077274|NCT02329847|Drug|Ibrutinib|Participants will receive oral capsule of ibrutinib once daily as either 420 mg or 560 mg or at recommended Phase 2 dose in any of the cohort.
16077275|NCT02329847|Drug|Nivolumab|Participants will receive nivolumab intravenously as 3 mg/kg on Day 1 every cycle of 14 days.
16077276|NCT02329834|Drug|Fursemide Injection Solution for subcutaneous administration (80 mg)|Furosemide Injection Solution, 10mL of undiluted buffered furosemide solution (8mg/mL)
16077277|NCT02329834|Drug|Furosemide Injection, USP|Furosemide Injection, USP (10mg/mL), 80 mg by intravenous administration.
16077278|NCT02329821|Other|hartmann solution|hartmann solution infusion in patients for hepatic resection
16077279|NCT02329808|Procedure|blood drawing|The association between conventional venous sampling and finger prick dried blood spot (DBS) will be associated by drawing blood in both ways.
16077280|NCT02329795|Radiation|Radiotherapy|60 Gy in 30 fractions, 5 days a week, modulated arc therapy.
16077281|NCT02329795|Drug|Temozolomide|Concomitant: 75 mg/m2 5 days a week from start of radiotherapy. Adjuvant: 150/200 mg/m2 in 5 days per 28 days in 6 months.
16077282|NCT02329782|Behavioral|Adherence Readiness Program|The ARP consists of pre-treatment (including practice trials to determine readiness for and timing of ART initiation), early-treatment, and ongoing maintenance training (using a performance-based, dose regulation mechanism to tailor the amount and intensity) phases
16077283|NCT02329769|Drug|PRO044 SC 6 mg/kg|
16077284|NCT02329769|Drug|PRO044 IV 6 mg/kg|
16077285|NCT02329769|Drug|PRO044 IV 9 mg/kg|
16077286|NCT02329756|Drug|Tranexamic Acid (TXA)|1g Tranexamic Acid (TXA) will be given at the time of delivery. If in 30 minutes, heavy bleeding continues, a 2nd dose will be administered.
16077287|NCT02329756|Drug|Sodium Chloride 0.9%|"Dose 1: 1 gram - to be administered by intravenous injection at an approximate rate of 1 mL/minute to all randomized women approximately 10 minutes prior to induction of anesthesia
~Dose 2: 1 gram - If 30 minutes after beginning the cesarean section there is significant bleeding as defined by the need for the transfusion of 4 or more units of blood products, or if there is a rebleed within the 24 hours after the first dose, a second dose may be given. To be administered by intravenous injection at an approximate rate of 1 mL/minute.
~The trial treatment injections should not be mixed with blood for transfusion, or infusion solutions containing penicillin or mannitol."
16077288|NCT02329743|Drug|RX-10045|topical therapy
16077289|NCT02329730|Biological|1μg/ml ESAT6-CFP10 and tuberculin purified protein derivative|Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 1μg/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 Allergen and TB-PPD only one time in the healthy subjects and the first part of tuberculosis subjects respectively.
16077290|NCT02329730|Biological|5μg/ml ESAT6-CFP10 and tuberculin purified protein derivative|Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 5g/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 Allergen and TB-PPD only one time in the healthy subjects and the first part of tuberculosis subjects respectively.
16077291|NCT02329730|Biological|10μg/ml ESAT6-CFP10 and tuberculin purified protein derivative|Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 10g/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 Allergen and TB-PPD only one time in the healthy subjects and the first part of tuberculosis subjects respectively.
16077292|NCT02329730|Biological|20μg/ml ESAT6-CFP10 and tuberculin purified protein derivative|Left arm intradermal injection of 0.1ml TB-PPD(50IU/ml) by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 20/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 Allergen and TB-PPD only one time in the healthy subjects and the first part of tuberculosis subjects respectively.
16077293|NCT02329730|Biological|1μg/ml ESAT6-CFP10 and placebo|Left arm intradermal injection of the placebo of 1μg/ml ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 1μg/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in the second part of tuberculosis subjects.
16077294|NCT02329730|Biological|5μg/ml ESAT6-CFP10 and placebo|Left arm intradermal injection of the placebo of 5μg/ml ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 5μg/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in the second part of tuberculosis subjects.
16077295|NCT02329730|Biological|10μg/ml ESAT6-CFP10 and placebo|Left arm intradermal injection of the placebo of 10μg/ml ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 10μg/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in the second part of tuberculosis subjects.
16077296|NCT02329730|Biological|20μg/ml ESAT6-CFP10 and placebo|Left arm intradermal injection of the placebo of 20μg/ml ESAT6-CFP10 by a syringe(1ml).Observe 30 minutes , if without obvious adverse reaction then right arm intradermal injection 20μg/ml ESAT6-CFP10 by a syringe(1ml). Inject ESAT6-CFP10 and placebo only one time in the second part of tuberculosis subjects.
16077297|NCT02329717|Drug|PBI 05204|PBI 05204 daily dosing
16077298|NCT02329704|Procedure|Diff-Quik staining for morphology evaluation|"Papanicolaou stain (haematoxylin, orange G6, and EA50) gives a clear difference between basophilic and acidophilic cell constituents and thereby enables a detailed examination of chromatin pattern, which is useful in the evaluation of sperm morphology and assessment of presence of immature spermatozoa. Cytoplasmic staining can vary between red and green dependent on ionic strength, pH, and composition of the cell department and the stain (OG6 and EA50).
~Morphological assessment for processed portions of semen. As separation process has to minimize the morphological abnormal sperm."
16077299|NCT02329704|Procedure|Motility Evaluation for grade A and B|"The better separation method will insure more progressive sperms after processing.
~Grading using A and B scale scored by (WHO 2010) references."
16077300|NCT02329704|Procedure|Concentration (mil/ml)|count of isolated sperms Using Makler chamber for count of sperm for each portion post processing.
16077301|NCT02329704|Procedure|24 H half life|"percentage of active motile to non motile sperms.
~Microscopic examination for each sample after 24 hours incubation, to evaluate the progressively motile sperm and those non progressive or non motile."
16077375|NCT02329041|Device|McGrath Series 5|one kind of videolaryngoscopes, which are widely used in airway management.
16077302|NCT02329704|Procedure|48 H half life|"percentage of active motile to non motile sperms.
~Microscopic examination for each sample after 48 hours incubation, to evaluate the progressively motile sperm and those non progressive or non motile."
16077303|NCT02329704|Procedure|HBA Testing|"The Hyaluronic Binding Assay (HBA®) is an important diagnostic tool for suspected male infertility in the analysis of semen. In a matter of minutes the HBA® slide provides an answer to the proportion of mature binding spermatozoa in the sample (The HBA® score %).
~By using HBA slide we can count the physiologically active sperms at each sample and calculate percentage of active sperms with reference to post processing count from 3rd investigating arm."
16077304|NCT02329704|Biological|Bacterial contamination|Routine bacterial culture using Blood Agar culture plates for 10 micron finally washed samples, to confirm presence of any bacteria contamination caused by carry over during processing.
16077305|NCT02329678|Procedure|Peripical surgery|Thirty patients meeting inclusion criteria were selected and allocated randomly into two groups: collagen membrane group and control group. Clinical and radiographic measurements were recorded during follow up at regular intervals of 0, 3, 6, 9, and 12 months after surgery. The criteria for success included the absence of clinical signs and symptoms, and complete or incomplete radiographic healing.
16077306|NCT02329665|Device|NeedleWays™ System|A total of 50 consecutive subjects scheduled for clinically indicated CT guided needle intervention procedure will be invited to enroll in the study.
16077307|NCT02329652|Device|Networked Neuroprosthetic System for Grasp and Trunk|Receive implanted networked neuroprosthesis
16077308|NCT02329639|Genetic|genetic interaction analysis|VEGFR-2 rs11133360/IL-8 rs4073 genetic interaction analysis
16077309|NCT02329626|Device|PET CT 18 FDG|"Positron emission tomography with 2-deoxy-2-[fluorine-18]fluoro- D-glucose integrated with computed tomography.
~This intervention is required for the observational needs of the study."
16077310|NCT02329613|Other|Standard evening meals.|Patients will receive usual evening meals.
16077311|NCT02329613|Other|Improved evening meal|Patients will receive improved evening meals. Improved meals will include enriched soup (with starches, butter, cheese or sour cream), a semi-liquid dairy dessert, fruit or a fruit dessert.
16077312|NCT02329600|Drug|green tea tablets (Green tea extract 5:1) 200 mg|Green tea is a product made from the Camellia sinensis plant. The fresh leaves are used to make medicine. the green tea extract is presented in a form of tablets 200 mg and is taken orally.
16077313|NCT02329600|Drug|Triamcinolone Acetonide|topical corticosteroids (Kenalog in orabase: Bristol-Myers, Squibb, Spain) applied topically 4 times a day i.e. following each meal and at bed time for one month
16077314|NCT02329587|Other|ERP plus tDCS|Participants in the ERP plus tDCS arm will receive an 11-session program, including 10 sessions which include both tDCS and ERP. During these sessions, 20 minutes of anodal tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise.
16077315|NCT02329587|Other|ERP plus sham tDCS|Participants in the ERP plus sham tDCS arm will receive an 11-session program, including 10 sessions which include both sham tDCS and ERP. During these sessions, 20 minutes of sham tDCS will be delivered over right inferior frontal gyrus prior to the ERP exercise.
16077316|NCT02329561|Drug|Tramadol extended release 200 mg|Tramadol extended release 200 mg: Administration of a single 200mg tramadol extended-release tablet
16077317|NCT02329561|Behavioral|CP/T|Subjects were evaluated for perception and tolerance of electrical current. An experimentally induced pain model utilizing electrical stimulation from the FDA approved Neurometer, as the painful stimulus was used to assess Current Perception Threshold and Pain Tolerance Threshold (CP/T) in young and elderly subjects following administration of tramadol and of placebo.
16077318|NCT02329561|Drug|Placebo|Administration of a single placebo tablet identical in appearance to a 200mg tramadol extended-release tablet
16077319|NCT02329548|Other|Alizarin Red|An Alizarin Red mixture will be applied to all exposed skin below the angle of the mandible. Once applied the patient will be tilted to 70 degrees. Serial photos will be taken once sweat begins and until conclusion of the test.
16077320|NCT02329535|Drug|Micronized progesterone|vaginal caps 400 mg daily up to 36 weeks of gestation
16077321|NCT02329522|Device|Ultrasonic Cardiac Output Monitor|"An Ultrasonic Cardiac Output Monitor (USCOM; USCOM Pty Ltd, NSW, Australia) is a non-invasive Doppler ultrasonography. It is capable of measuring haemodynamic parameters non-invasively and appears to be simple and rapid to use, portable, relatively inexpensive and has less potential complications compared with the standard technique, pulmonary artery thermodilution (PATD).
~USCOM scans will be performed on patients to measure direct and derived haemodynamic variables, which will be performed in the supine position wherever possible. A transducer will be placed on the chest in either the suprasternal position to measure trans-aortic blood flow, or the left parasternal position to measure transpulmonary blood flow."
16077322|NCT02329522|Device|Spirometry|Spirometry assesses lung function through measuring the amount (volume) and/or speed (flow) of air that can be inhaled and exhaled. Patients are regarded as COPD if their Forced expiratory volume in 1 second (FEV1) to Forced vital capacity (FVC) ratio are smaller than 70%. Patients were required to perform three blowing manoeuvres, and post-bronchodilator test results were obtained within 20 minutes to 4 hours after inhaling 400 mg of salbultamol.
16077323|NCT02329509|Procedure|two stage palate surgical repair|two stage palate surgical repair with a hard palate closure at 3 to 4 years old
16077324|NCT02329509|Procedure|One stage Palate Surgical repair|One stage palate repair at the age of 9 to 24 months old
16077325|NCT02329496|Device|Lotus Valve and LOTUS Edge Valve System|Transcatheter aortic valve replacement (TAVR) with the Lotus Valve System with the Next Generation Delivery System and LOTUS Edge Valve System, with either the Lotus Introducer or iSleeve Introducer Sets
16077326|NCT02329470|Procedure|Withdrawal of continuous positive airway pressure treatment|Withdrawal of continuous positive airway pressure treatment
16077327|NCT02329457|Biological|Zostavax|varicella zoster vaccine
16077328|NCT02329457|Biological|Normal Saline|normal saline placebo vaccine
16077329|NCT02329444|Procedure|Remote ischemic preconditioning|Appropriately sized sphygmomanometer cuff placed around right upper arm; where contraindicated, left arm, with inflation of the cuff up to 200mmHg for 5 minutes, followed by deflation of 5 minutes to allow reperfusion with cycle repeated 3 times.
16077376|NCT02329041|Device|Airtraq|another kind of videolaryngoscopes, which are also widely used in airway management.
16077377|NCT02329028|Device|Prehospital mini-EEG|Observational
16077330|NCT02329444|Procedure|Sham ischemic preconditioning|Appropriately sized sphygmomanometer cuff placed around right upper arm; where contraindicated, left arm, with inflation of the cuff up to 50mmHg for 5 minutes, followed by deflation of 5 minutes to allow reperfusion with cycle repeated 3 times.
16077331|NCT02329431|Behavioral|activation curriculum|psychosocial activation curriculum
16077332|NCT02329431|Behavioral|support group|parent directed support group
16077333|NCT02329418|Other|Explaining withholding and withdrawing life-sustaining therapies along with a written document|The document describes the law and the role of family members and medical team in the decision.
16077334|NCT02329418|Other|Explaining withholding and withdrawing life-sustaining therapies following standard procedure|
16077335|NCT02329405|Drug|Rifampicin|
16077336|NCT02329405|Drug|Placebo|
16077337|NCT02329379|Drug|Levothyroxine|
16077338|NCT02329366|Other|Specimen Collection|. In this study, diabetic patients undergoing DFU debridement under the standard of care will be asked for their permission to collect the debrided tissue for use in scientific research.
16077339|NCT02329353|Drug|Lactobacillus brevis CD2 Lozenges|Each lozenge contains not less than 1 billion Colony forming unit of Lactobacillus brevis CD2
16077340|NCT02329340|Behavioral|Am Academy of Pediatrics print materials|Print materials of injury prevention content.
16077341|NCT02329340|Behavioral|Family safety 1-2-3|Theoretically based school-aged childhood injury prevention videos for families
16077342|NCT02329327|Biological|Andexanet|There were 2 possible dosing regimens: Low dose = 400 milligram (mg) bolus plus 4 mg/minute continuous infusion for 120 minutes; High dose = 800 mg bolus plus 8 mg/minute continuous infusion for 120 minutes.
16077343|NCT02329301|Drug|MDA with DHAp (Eurartesim)|Eurartesim is the brand name.
16077344|NCT02329301|Drug|Focal MDA with DHAp (Eurartesim)|Eurartesim is the brand name.
16077345|NCT02329288|Drug|Triamcinolone Acetonide|
16077346|NCT02329288|Drug|placebo|
16077347|NCT02329275|Procedure|Testicular biopsy|
16077348|NCT02329262|Behavioral|Mentoring to be Active with Accelerometers|Trained high school mentors will deliver a 10 session curriculum targeting physical activity to younger teens.
16077349|NCT02329262|Behavioral|Planning to be Active with Accelerometers|Health education teachers will deliver the 10 session curriculum targeting physical activity to high school students enrolled in health courses.
16077350|NCT02329249|Behavioral|Smokefree Partners: 21 Days to Freedom|Treatment subjects, who chose a quit date, were given 21 sessions to be viewed one session (i..e, one day) at a time, and an in-person smoking cessation coach to support them through their quit process via tailored email or phone coaching messages. Treatment users were encouraged to use pharmacological aids in their quit attempt, but smoking cessation aids were not provided.
16077351|NCT02329249|Other|Wait-List Control|Subjects randomized to the control condition were placed on a wait-list and given access to the smoking cessation program after 120 days and completion of the 120-day follow-up assessment.
16077352|NCT02329223|Biological|Omalizumab|Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.
16077353|NCT02329223|Other|Placebo|Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug.
16077354|NCT02329197|Drug|Human Chorionic Gonadotropin (HCG)|intrauterine injection of HCG prior to embryo transfer in an IVF cycle
16077355|NCT02329184|Drug|MYK-461|
16077356|NCT02329171|Drug|Imiquimod|Imiquimod 5% cream will be administered in a vaginal applicator, containing 12,5 mg of imiquimod (one sachet). The cream will be self-administered three times per week, by use of a vaginal applicator.
16077357|NCT02329171|Procedure|LLETZ|Standard treatment consists of a LLETZ procedure, in which excision of the transformation zone and macroscopic lesions is performed by a monopolar loop electrode, under local anaesthesia. The excision is usually performed in two or three steps, depending on the size of the lesions.
16077358|NCT02329158|Drug|6% hydroxyethyl starch|
16077359|NCT02329145|Procedure|renal denervation|
16077360|NCT02329132|Drug|Ranibizumab|Each eye will be treated with three initial monthly injections of intravitreal ranibizumab 0.5 mg (Lucentis), followed by retreatment as needed, guided by monthly clinical examinations including biomicroscopy, VA measurement, and optical coherence tomography (OCT) examination.
16077361|NCT02329119|Other|electrophysiological recordings|
16077362|NCT02329106|Device|Irreversible electroporation (IRE)|Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels,bile ducts and diaphragmatic dome.
16077363|NCT02329093|Procedure|To MRI-detecting bone signal changes in radiographic hip OA|To examine whether or not non-weight bearing reduced OA progression
16077364|NCT02329080|Drug|Methotrexate|methotrexate 3.5 g/m2 on day 1 courses 1, 2,3 of MATRIX regimen
16077365|NCT02329080|Drug|Rituximab|Rituximab 375 mg/m2 as conventional IV infusion on day 0 courses 1, 2,3 (MATRIX regimen) and on day 1 courses 4,5,6 (R-ICE)
16077366|NCT02329080|Drug|Cytarabine|Cytarabine 2 g/m2 every 12 hours, in 3-hr infusion on days 2,3 courses 1, 2,3 (MATRIX regimen)
16077367|NCT02329080|Drug|Thiotepa|Thiotepa 30 mg/m2 in 30 minutes infusion on day 4 courses 1, 2,3 (MATRIX regimen) and 5 mg/kg in 250 ml of saline sol. in 2-hrs infusion every 12 hours on day -5 and -4 of conditioning and ASCT
16077368|NCT02329080|Drug|liposomial cytarabine|Intrathecal liposomial cytarabine 50 mg on day 5 courses 1, 2,3 (MATRIX regimen) and on day 4 courses 4,5,6 (R-ICE)
16077369|NCT02329080|Drug|Etoposide|Etoposide 100 mg/m2/d in 500 mL saline sol. in 30 minutes on day 1-2-3 courses 4,5,6 (R-ICE)
16077370|NCT02329080|Drug|Ifosfamide|Ifosfamide 5 g/m2 in 1.000 mL saline sol. in 24-hour infusion on day 2 courses 4,5,6 (R-ICE)
16077371|NCT02329080|Drug|Carmustine|BCNU (carmustine) 400 mg/m2 in 500 mL glucose 5% sol. in 1-hr infusion on day-6 of conditioning and ASCT
16077372|NCT02329080|Radiation|whole brain radiotherapy|whole-brain irradiation 36 Gy + tumor- bed boost 10 Gy in patients with residual disease in the parenchymal brain/cerebellum.
16077373|NCT02329067|Other|walnuts|consumption of 43 g walnuts per day
16077374|NCT02329054|Drug|Favipiravir|"Group A1: Day-0 (inclusion), h0: 2400 mg; h8: 2400 mg; h16: 1200 mg. Day-1 to Day-9: 1200 mg bid.
~Group A2: Day-0 (inclusion), h0: 2400 mg; h8: 2400 mg; h16: 1200 mg. Day-1 to Day-9: 1200 mg bid.
~Group C: daily dosages will be adapted to their body weight."
16077378|NCT02329015|Behavioral|Yoga-informed Health and Wellness Program|The HWP will be comprised of physical postures, breathing exercises, a period of sitting in stillness (meditation) and relaxation provided two times per week, 45 minutes per session, for the entire school year (Sept. - June).
16077379|NCT02329015|Behavioral|Physical Education Class|Standard physical education
16077380|NCT02329002|Device|Magnetic resonance imaging|MR imaging protocol should include a thin-slice (3-4 mm) short TI inversion recovery (STIR) sequence or fat-saturated T2-weighted images in axial direction. Furthermore, a 3D-T1 weighted sequence with isotropic voxels will be obtained, with reconstruction in 3 directions. If suspicious lesions are detected, additional MR imaging has to be performed, including contrast-enhanced images.
16077381|NCT02328989|Device|Pessary|The device will be placed in the vagina during the consultation. It is rinsed in sterile water for lubrification and left in place until delivery or remove at 36 weeks in case of no delivery before. There is no need to use any analgesia. The good position of the pessary is checking in the same time than the placement with digital examination.
16077382|NCT02328976|Other|functional Magnetic Resonance Imaging (fMRI)|both chronic and episodic patients with migraine have a specific functional Magnetic Resonance Imaging (fMRI)
16077383|NCT02328963|Drug|Everolimus|"Everolimus : 0.75 bid, targeted to 3-8 ng/ml
~Cyclosporin A :
~CsA target ranges for Arm 1 will be 100-200 ng/mL from Day 3 to Month 2, decreasing to 75-150 ng/mL from Month 2 to Month 4 and 25-50 ng/mL from Months 6 to 12.
~Corticosteroids :
~Méthylprednisolone: 500 mg at Day 0, 120 mg à Day 1. Prednisone or equivalent: 20 mg/d from Day 3. Corticosteroid dosing will be tapered according to center standard practice but to not less than 5 mg per day for the duration of the 12-month study
~Basiliximab :Day 0: 20 mg ; Day 4: 20 mg"
16077384|NCT02328963|Drug|mycophenolic acid|"Mycophenolic acid :
~1080 mg bid for one month, then 720 mg bid
~Cyclosporin A :
~CsA target ranges for Arm 1 will be 100-200 ng/mL from Day 3 to Month 2, decreasing to 75-150 ng/mL from Month 2 to Month 4 and 25-50 ng/mL from Months 6 to 12.
~Corticosteroids :
~Méthylprednisolone: 500 mg at Day 0, 120 mg à Day 1. Prednisone or equivalent: 20 mg/d from Day 3. Corticosteroid dosing will be tapered according to center standard practice but to not less than 5 mg per day for the duration of the 12-month study
~Basiliximab :Day 0: 20 mg ; Day 4: 20 mg"
16077385|NCT02328950|Drug|Fludarabine and Cytarabine followed by IV busulfan and cyclophosphamide|Fludarabine (F) 30 mg/m²/day for 5 days (day -12 to day-8) Cytarabine (A) 2g/m²/day for 5 days (day -12 to day-8) Bulsufan (Bu) 0.8mg/kg/day for 3 days (day -7 to day-5) Cyclophosphamide(Cy) 1.8g/m²/day for 3 days (day -4 to day-3)
16077386|NCT02328937|Device|etafilcon A|spherical hydrophilic soft contact lens worn in a daily wear modality
16077387|NCT02328937|Device|lotrafilcon B|
16077388|NCT02328937|Device|comfilcon A|
16077389|NCT02328924|Other|LH value|analyzed LH value in the the arms of the study, fixed and flexible protocols
16077390|NCT02328911|Device|Laser treatment|Laser energy will be applied to the skin of the back and feet manually by physician though a device with a movable head, in contact with the skin, that emits therapeutic dual-wavelength infrared laser energy as well as red visible light.
16077391|NCT02328911|Device|Sham treatment|A sham treatment will be applied to the skin of the back and feet manually by physician though a device with a movable head, in contact with the skin, that emits only red visible light.
16077392|NCT02328898|Device|Cre8 Stent|Comparison of the Resolute Integrity stent with the Cre8 stent.
16077393|NCT02328898|Device|Resolute Integrity stent|
16077394|NCT02328885|Other|DLI of the 20 fraction of the UCBT|Administration of 20 fraction of the UCBT
16077395|NCT02328872|Device|Molecular testing for HPV|Molecular testing for HPV with a test allowing partial genotyping for separate identification of types 16/18 from cervical samples. The technology used in this trial will be approved by the Therapeutic Goods Administration (TGA) Australia. It will identify the major HPV oncogenic genotypes in a pool and separately identify HPV 16 and 18. It will also satisfy performance criteria for relative sensitivity and specificity compared to Hybrid Capture 2 (HC2 ) as articulated by Meijer et al, 2009, Guidelines for human papillomavirus DNA test requirements for primary cervical cancer screening in women 30 years and older.
16077396|NCT02328872|Device|Liquid Based Cytology|The liquid based cytology (LBC) used in this trial will be will be approved by the Therapeutic Goods Administration (TGA) Australia for LBC and appropriately validated and (TGA approved) to perform human papillomavirus testing from a cytology sample.
16077397|NCT02328859|Other|Virtual Reality Gait Training|A Virtual Gait Retraining System (VGRS) will be used to train amputees for six weeks. the system consists of an actuated treadmill, a virtual environment and an avatar
16077398|NCT02328859|Other|Treadmill Gait Training|A conventional treadmill with no visual display will be used to gait train amputees for a period of six weeks.
16077399|NCT02328833|Other|Experimental strategies of guidelines implementation|Experimental strategies of Depression Guidelines implementation in Primary Care Centers. The active process includes the establishment of local implementation teams, seminars, regular feedback and follow-up visits for four months.
16077400|NCT02328820|Other|Percutaneous coronary intervention (PCI)|For lesions with both FFR<=0.8 and CFR<2.0
16077401|NCT02328820|Other|Optimal medical therapy (OMT)|For lesions with FFR>0.8 or CFR>=2.0 or both
16077402|NCT02328807|Procedure|Radio-Frequency Ablation (RFA)|RFA is a minimally invasive procedure. It is an image-guided technique that heats and destroys cancer cells. In RFA, imaging techniques such as ultrasound or magnetic resonance imaging (MRI) are used to help guide a needle electrode into a cancerous tumor. High-frequency electrical currents are then passed through the electrode, destroying the cancer cells.
16077403|NCT02328794|Behavioral|E-cigarette free access|Participants in this arn will be given free access to e-cigarettes to help quit smoking
16077404|NCT02328794|Behavioral|E-cigarette/NRT/Zyban/Chantix Choice|Participants in this arn will be given free access to cessation aids to help quit smoking
16077405|NCT02328794|Behavioral|Outcome Incentive arm|Participants in this arm will be earn incentives across 6 months for verified abstinence.
16077406|NCT02328794|Behavioral|Loss framing incentive arm|Participants in this arm will be told they have a pre-funded account with money that is theirs if they quit smoking.
16077407|NCT02328794|Behavioral|Control|Participants will have access to information and advice on quitting smoking. This is a control and no actual intervention will be applied.
16077408|NCT02328781|Device|Drug-eluting stent|
16077409|NCT02328768|Drug|Omegaven|
16077410|NCT02328755|Drug|peg-IFN-α|
16077412|NCT02328755|Drug|Tacrolimus|Calcineurin inhibitor administered along with HCT for Graft Versus Host Disease (GVHD) prophylaxis. Cyclosporine may be substituted if patients cannot tolerate tacrolimus.
16077413|NCT02328755|Drug|Methotrexate|Administered along with HCT for Graft Versus Host Disease (GVHD) prophylaxis.
16077414|NCT02328742|Biological|Hysteroscopy + endometrial biopsy|"The day of the first diagnostic hysteroscopy an endometrial biopsy is performed (biopsy A1). These biopsies will be used for the evaluation of TGFbeta, Activin A and inhibin.
~This intervention is required for the observational needs of this study."
16077415|NCT02328742|Other|Telephone call|"Patients will be contacted via telephone 6 months after first hysteroscopy.
~This intervention is required for the observational needs of this study."
16077416|NCT02328742|Biological|Resection + endometrial biopsy|"If patients are found to have synechia or another intracavitary pathology, resection is scheduled 1-2 months later. A second endometrial biopsy is performed at this time.
~This intervention is required for the observational needs of this study."
16077417|NCT02328742|Biological|Follow-up hysteroscopy + endometrial biopsy|"For patients having had resection, a follow-up hysteroscopy is performed 1 to 3 months later. An endometrial biopsy will be performed at this time.
~This intervention is required for the observational needs of this study."
16077418|NCT02328729|Procedure|mandibular block with Epinephrine|Delivery of mandibular block anesthesia for dental treatment with Lidocaine HCl 2% with 1:100,000 Epineprine
16077419|NCT02328729|Procedure|C-CLAD-IL with Epinephrine|Delivery of C-CLAD-ILanesthesia for dental treatment with Lidocaine HCl 2% with 1:100,000 Epineprine
16077420|NCT02328729|Procedure|Infiltration with Epinephrine|Delivery of infiltration anesthesia for dental treatment with Lidocaine HCl 2% with 1:100,000 Epineprine
16077421|NCT02328729|Procedure|Mandibular block without Epinephrine|Delivery of mandibular block anesthesia for dental treatment with Mepivacaine 3% without Epineprine
16077422|NCT02328729|Procedure|C-CLAD-IL without Epinephrine|Delivery of C-CLAD-ILanesthesia for dental treatment with Mepivacaine 3% without Epineprine
16077423|NCT02328729|Procedure|nfiltration without Epinephrine|Delivery of infiltration anesthesia for dental treatment with Mepivacaine 3% without Epineprine
16077424|NCT02328716|Procedure|Cytoreduction|Cytoreduction
16077425|NCT02328716|Drug|Hipec with Cisplatin|Intraoperative Intraperitoneal Hyperthermic Chemotherapy (Hipec)+Cisplatin
16077426|NCT02328703|Other|Reiki Therapy|Reiki is a biofield energy therapy that is based on the idea that there is a universal energy that supports the body's innate healing abilities. A trained Reiki Master uses their hands as a conduit of the energy that goes naturally to any area of the recipient's body where it is needed. This provides a means for life force energy to recharge and rebalance the human energy fields, creating optimal conditions needed by the body's natural healing system.
16077427|NCT02328690|Other|Binaural Beat Technology|A phenomenon when two nearly similar frequencies (between 30-1000 hertz [Hz]) are presented to each ear and the brain detects the difference between the two sounds. These two sounds are processed in the superior olivary nucleus of each hemisphere of the brain. This integration of brain hemispheres produces a frequency that in turn affects the reticular activating system which alters the electrical potentials of the thalamus and cerebral cortex changing brainwave frequency.
16077428|NCT02328664|Procedure|Flexible sigmoidoscopy or colonoscopy|Depending on the localization of the scar of the malignant polyp, either a flexible sigmoidoscopy or colonoscopy will be done to take biopsies from the polypectomy scar.
16077429|NCT02328651|Drug|Ribavirin plus Xiao'er jiebiao oral liquid|"For mild (Phase I) patients: recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d（ diluted in 100ml 5%GS），qd, ivgg, in combination using of Xiaoer jiebiao oral liquid 5 ml, bid for children aged 1-2 years, tid for children aged 3-5 years.
~For moderate (Phase II) patients:
~recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d（ diluted in 100ml 5%GS），qd, intravenous drip, in combination using of Xiaoer jiebiao oral liquid 5 ml, bid for children aged 1-2 years, tid for children aged 3-5 years.③anti-intracranial pressure treatment: mannitol 2~5ml/kg,iv, Bid~tid）"
16077430|NCT02328651|Drug|Ribavirin|"For mild (PhaseI) patients : recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d（ diluted in 100ml 5%GS），qd, intravenous drip.
~For moderate (PhaseII) patients: recommended treatment according to naitonal guildeline for treatment of mouth-foot-hand diseases 2010, including ①treatment for control symptoms ② ribavirin 15mg/kg/d（ diluted in 100ml 5%GS），qd, intravenous drip, in combination using of Xiaoer jiebiao oral liquid 5 ml, bid for children aged 1-2 years, tid for children aged 3-5 years.③anti-intracranial pressure treatment: mannitol 2~5ml/kg, iv, Bid~tid）"
16077431|NCT02328638|Behavioral|Parent Education Program|The PEP intervention consists of didactic sessions regarding basic information about Autism Spectrum Disorders.
16077432|NCT02328638|Behavioral|Manual-based Behavioral Treatment|The Manual-based Interdisciplinary Behavioral Treatment consists of nutritional and behavioral interventions to improve dietary intake (increase water, decrease sweetened beverages and snack foods, improve balanced diet), increase exercise, and teach behavioral strategies to address barriers to these goals.
16077433|NCT02328612|Other|Intravenous infusion of cells|"The treatment administration will be infused intravenously to the subjects after randomization:
~An hour after the end of the eASCs administration, all subjects will be given an intravenous dose of LPS. Subjects will be allowed to leave in the evening once deemed clinically stable by the investigator."
16077434|NCT02328599|Procedure|Bariatric surgery involving Roux-en-Y gastric bypass|Subjects previously underwent Bariatric surgery involving Roux-en-Y gastric bypass (RYGB) surgery at one of the 4 participating sites and will be followed prospectively.
16077435|NCT02328599|Procedure|Bariatric surgery involving Laparoscopic adjustable gastric banding|Subjects previously underwent Bariatric surgery involving laparoscopic adjustable gastric banding (LAGB) surgery at one of the 4 participating sites and will be followed prospectively.
16077436|NCT02328599|Procedure|Bariatric surgery involving Laparoscopic sleeve gastrectomy|Subjects previously underwent Bariatric surgery involving laparoscopic sleeve gastrectomy (LSG) surgery at one of the 4 participating sites and will be followed prospectively.
16077437|NCT02328586|Other|Group Acupuncture|
16077438|NCT02328573|Behavioral|Communal singing|
16077439|NCT02328547|Drug|Fecal microbiota transplantation capsules|Fecal microbiota transplantation capsules contain extensively screened donor stool and are prepared by OpenBiome, Medford, MA.
16077440|NCT02328547|Drug|Placebo capsules|Placebo capsules prepared by OpenBiome, Medford, MA
16077441|NCT02328534|Behavioral|Blastocyst Formation Rate|"Embryos developed at Day3 cultures, are continued for Day5 culture tho reach blastocyst stage. The percentage of blastocyst produced from cleaved embryos to be evaluated ar rate.
~The evaluation with doe one time using Density Gradient semen one time and Swimming down semen another time."
16077442|NCT02328534|Procedure|Blastocyst Rate|"Day 5 embryo transfer achieved pregnancy are compared with total embryo transfer cases at Day5.
~The evaluation with doe one time using Density Gradient semen one time and Swimming down semen another time.
~Pregnancy confirmed with day 12 after Et and repeated with 48 hours after 1st exam."
16077443|NCT02328534|Procedure|Pregnancy Rate|"All pregnancy achieved from all ET. Pregnancy confirmed with day 12 after Et and repeated with 48 hours after 1st exam.
~The evaluation with doe one time using Density Gradient semen one time and Swimming down semen another time."
16077444|NCT02328521|Drug|Nicorandil|Nicorandil is given once before PCI and given 3 times daily for 30 days after PCI.
16077445|NCT02328521|Drug|nicorandil placebo|Nicorandil placebo is given once before PCI and given 3 times daily for 30 days after PCI.
16077446|NCT02328508|Device|Hyperbaric oxygen therapy|HBOT was carried out in a hyperbaric chamber for 120-min per session, five days a week for four consecutive weeks (20 treatment sessions).
16077447|NCT02328495|Drug|Misoprostol|"Misoprostol (400µg) will be administered vaginally 12 hours before office hysteroscopy. A rigid 2.9 mm hysteroscope with 30° forward oblique lens and outer sheath diameter of 5 mm will be used in the procedure. The uterine cavity will be distended by warm saline at a pressure between 60-80 mmHg. All the procedures will be performed during the proliferative phase using the vaginoscopic approach as described by Betocchi and Selvaggi in 1997 . All the procedures will be diagnostic.
~Pain intensity will be assessed by visual analogue scale during the examination and 30 minutes after the procedure. A visual analogue scale ranging from 0 to 10 will be used (zero indicates no pain and 10 indicates the worst possible experienced pain)."
16077448|NCT02328495|Other|Bladder Filling|"Patients in bladder filling group will be instructed to drink one liter of water and to avoid urination during the one and half hour period before office hysteroscopy procedure..A rigid 2.9 mm hysteroscope with 30° forward oblique lens and outer sheath diameter of 5 mm will be used in the procedure. The uterine cavity will be distended by warm saline at a pressure between 60-80 mmHg. All the procedures will be performed during the proliferative phase using the vaginoscopic approach . All the procedures will be diagnostic.
~Pain intensity will be assessed by visual analogue scale during the examination and 30 minutes after the procedure. A visual analogue scale ranging from 0 to 10 will be used."
16077449|NCT02328482|Drug|Tehalose 30gr|Trehalose 30 g for IV infusion administered every week over an additional 52 weeks
16077450|NCT02328469|Drug|symptomatic therapy|patients will receive symptomatic therapy with antipyretics, analgetics, antiemetics and parenteral hydration: metamizole, paracetamol, thiethylperazine, saline
16077451|NCT02328469|Drug|Ceftriaxone or Doxycycline|beside symptomatic therapy (metamizole, paracetamol, thiethylperazine, saline), patients with proven or probable Lyme neuroborreliosis will be treated with ceftriaxone 2 g intravenously once daily for 14 days OR doxycycline 100 mg orally twice daily for 14 days
16077452|NCT02328469|Other|questionnaire|Control subjects will be asked to answer a questionnaire asking about the presence and frequency of nonspecific symptoms.
16077453|NCT02328469|Drug|Acyclovir|Patients will be treated with intravenous acyclovir 10 mg per kg three times daily for 14 to 21 days.
16077454|NCT02328456|Other|SMS and free eye drops|The SMS reminder message will sent to the SMS associated with free eye drops group patients 1 week and 1 day before there appointment to remind them the exact time and address of the revisit appointment.The eye drops will be offered free to the the SMS associated with free eye drops group patients when they revisit on time.
16077455|NCT02328443|Drug|Midazolam|
16077456|NCT02328443|Drug|itraconazole|
16077457|NCT02328443|Drug|rifampicin|
16077458|NCT02328430|Device|Kinnect 3 camera|comparison of Kinnect 3 measures of chest wall movement during standard spirometry
16077459|NCT02328417|Other|Consecutive radical cystectomies|Pre-, intra- and post-operative clinical measures during radical cystectomy clinical process
16077460|NCT02328404|Drug|50,000 IU vitamin D3|Film-coated tablet Biodal 50,000 IU containing cholecalciferol 50,000 IU
16077461|NCT02328404|Drug|Placebo|Placebo film-coated tablet of Biodal 50,000 IU
16077462|NCT02328378|Procedure|Quadratus Lumborum block|Patients will receive a bilateral Quadratus Lumborum block using 0.125% Bupivacaine in a dose of 0.2ml/kg body weight, after the end of surgery.
16077463|NCT02328365|Other|Structured medical follow-up after operation|Patients in the intervention arm are seen by a physician on the 4th or 5th postoperative day before discharge to pick up and manage any medical problems, and are furthermore seen in the cardiology clinic 1 month after operation, and in the pulmonary medicine clinic 1 and 3 months after operation
16077464|NCT02328352|Procedure|BP selfstanding felt|intervention of laparotomy with the incision of 10 cm navel-pubis will be performed, splaying of the skin and subcutaneous layers, then will be incised the fascia plane, and muscles. Ten rabbits (hereafter defined as BPR1-BPR10) will receive 2x2cm2 samples of BP selfstanding felt in a pocket created between muscular fascia and large muscles of the abdominal wall.
16077465|NCT02328352|Procedure|PP mesh|intervention of laparotomy with the incision of 10 cm navel-pubis will be performed, splaying of the skin and subcutaneous layers, then will be incised the fascia plane, and muscles. A 2x2cm2 sample of PR (polypropylene) prosthesis was implanted without stitches into a pocket between large abdominal muscle and abdominal fascia
16077466|NCT02328352|Procedure|BP intraperitoneal mesh|Laparotomy on the linea alba carried out deeply for entering into the abdominal cavity, a 2x2cm2 BP sample implantation with the rough side facing the parietal peritoneum surface and the smooth and brilliant surface facing to the visceral peritoneum and gut
16077467|NCT02328352|Procedure|control group|observational intervention in 5 rabbits with the same body weight and the same age will be observed and will be feeded in the same way of the BP device intraperitoneal implanted group
16077468|NCT02328339|Other|Tea|Black tea infusion equivalent to approximately 530 mg total polyphenols expressed as gallic acid equivalents
16078243|NCT02322216|Drug|Olopatadine Hydrochloride Ophthalmic Solution 0.2%|
16077469|NCT02328339|Other|Placebo|Placebo matched to tea with respect to taste and appearance
16077470|NCT02328326|Other|CO-IMPACT|Primary care-integrated activation and social support intervention that provides tools and training in patient activation and effective support techniques for patients and their family supporter
16077471|NCT02328326|Other|PACT|participants will receive PACT care for high-risk diabetes, which includes (at primary care team discretion): nurse care manager visits, diabetes education classes, chronic disease self-management groups, telehealth, clinical pharmacist visits
16077472|NCT02328313|Behavioral|Walk with Ease Program|The Walk With Ease Program sets a goal for participants to walk 30 minutes a day five times a week and gives helpful hints on how to achieve this goal.
16077473|NCT02328300|Drug|FLT PET/MR|Each participant will be injected with FLT, a common PET radiotracer for brain tumors and lesions, and then will complete one (1) PET/MR scan.
16077474|NCT02328287|Drug|ALLOB®|Each patient will undergo a single administration of ALLOB® into the failed fusion lumbar level under anesthesia.
16077475|NCT02328274|Procedure|A Modified Technique for Laparoscopic Subtotal Hysterectomy|incorporation of two methods of vessels ligation and laparoscopic in situ morcellation
16077476|NCT02328261|Drug|Icotinib|Icotinib (125 mg tablet) is orally administered three times daily until disease progression or unaccepted toxicity.
16077477|NCT02328248|Procedure|Biological patch|Use biological patch as opposed to plastic patch to repair hiatal hernia laparoscopically
16077478|NCT02328235|Other|High Saturated Fat Diet|"Prior to the high fat diet and after baseline testing, subjects will be asked to eat a standard diet to lead-in to the high fat diet condition. The diet will contain 55% of calories as carbohydrate, 30% as fat, and 15% as protein. The high fat diet will contain 50-60% of calories as fat, 20-30% as carbohydrate, and 10-20% as protein. Subjects will be provided with all of their meals throughout the study."
16077479|NCT02328222|Drug|ESW group|CORTICOSTEDORID TREATMENT WAS AS FOLLOWS: day zero post-transplantation (DP 0), 500 mg/day of MPD; (DP 1), 250 mg MPD; (DP 2), 125 mg MPD; (DP 3), 60 mg MPD; (DP 4), 30 mg MPD; and (DP 5), PREDNISONE AS DOSES 1 MG/KG (1 MONTH) AND A REDUCTION TO ACHIEVE 0.1 MG/KG IN THE 3rd MONTH.
16077480|NCT02328209|Drug|ranibizumab|0.5mg/0.05ml, intravitreal injection, frequency: each 8 or 12 weeks
16077481|NCT02328196|Behavioral|The Danish McGill Ingestive Skills Assessment (MISA-DK)|The MISA measures the performance of dysphagic patients during the patient's usual mealtime routine.
16077482|NCT02328183|Drug|Polymyxin B|administrate drug by 0.75-1.25 mg/kg/dose intravenously q 12 hrs both saline and dextrose solution can be dissolved duration 7-14 days
16077483|NCT02328170|Other|EUROIMMUN Allergy|Immunoblot assay
16077484|NCT02328170|Other|ImmunoCap|Fluoroallergosorbent test
16077485|NCT02328157|Device|Vitrectomy with cataract surgery and toric IOL|
16077486|NCT02328157|Device|Vitrectomy with cataract surgery and common IOL|
16077487|NCT02328144|Drug|Metronidazole|Patients were assigned to two groups, one of them received oral metronidazole (study group) and the other, homologated placebo (control group) after hemorrhoidectomy. Then, postoperative pain was assessed by visual analog scale at 6 and 12hrs, 1, 4, 7 and 14 days
16077488|NCT02328144|Drug|Placebo|Patients were assigned to two groups, one of them received oral metronidazole (study group) and the other, homologated placebo (control group) after hemorrhoidectomy. Then, postoperative pain was assessed by visual analog scale at 6 and 12hrs, 1, 4, 7 and 14 days.
16077489|NCT02328118|Drug|Ranibizumab|A week before 25-gauge vitrectomy, all subjects in Ranibizumab group will receive Ranibizumab 0.5mg/0.05 ml intravitreal injection. All patients in this group will receive Triamcinolone Acetonide(4mg/0.1ml) during operation.
16077490|NCT02328118|Drug|Triamcinolone Acetonide|A week before 25-gauge vitrectomy, all subjects in Triamcinolone Acetone group will receive Triamcinolone Acetone 4mg/0.1 ml intravitreal injection. All patients in this group will receive Triamcinolone Acetonide(4mg/0.1ml) during operation.
16077491|NCT02328105|Drug|Carboplatin|Dosing: AUC = 6; on Day 1
16077492|NCT02328105|Drug|Abraxane|100 mg/m^2; Days 1, 8, 15
16077493|NCT02328092|Device|rSMS in treatment of Nocturnal Enuresis|Real rSMS (15 Hz at 50% of maximum stimulator output (10 seconds on and 30 seconds off) with a total of 1500 pulses and the hand of the coil upword. The stimulation was repeated for 10 sessions, 5 sessions per week and 2 days off. Sham rSMS received stimulation using the same coil, the same session frequency, in the same setting, but the coil was tilted 90.
16077494|NCT02328079|Drug|Steroids (Prednisolone) and Steroids plus Antiviral (Prednisolone + acyclovir)|Group allocations: Steroid group (prednisolone 60 mg /day IM /IV), Steroid plus Antiviral group (Prednisolone IM/ IV 60 mg /day + IV acyclovir 500 mg three time /day for 6 consecutive days) then reduced by 10 mg /day (for a total treatment time for 12 days) were placed in serially-numbered opaque closed envelopes. Each patient was placed in the appropriate group after opening the corresponding sealed envelope.
16077495|NCT02328066|Device|NBI used by trained endoscopists|Examination of colon lesions, using NBI and NICE classification, by endoscopists who previously performed an easy learning program. The learning program consists on the reading of two reference articles and a tutorial explaining the NICE classification. This tutorial shows several lesions and describes the characteristic features in which the classifications focus on.
16077496|NCT02328053|Procedure|collagen crosslinking group|collagen crosslinking with riboflavin and Ultraviolet A
16077497|NCT02328053|Drug|Topical anti-fungal therapy|topical antifungal medications like natamycin eye drops and voriconazole eye drops
16077498|NCT02328040|Drug|Placebo and Insulin monotherapy via CL|In the control arm patient receives a placebo pill with the closed loop with insulin/novolog (placebo and insulin/novolog via CL)
16077499|NCT02328040|Drug|Sitagliptin and insulin/novolog via CL|In the treatment arm the participant receives a single dose of sitagliptin with closed loop with insulin/novolog (Sitagliptin and insulin/novolog via CL), Part B
16077500|NCT02328027|Drug|99mTc-rhAnnexin V-128|1 single intravenous bolus administration of 250 MBq, at Day 1 and at Day 42.
16077501|NCT02328014|Drug|Acalabrutinib|Oral
16077502|NCT02328014|Drug|ACP-319|Oral
16077503|NCT02328001|Behavioral|Debriefing endoscopists of the procedure accessory costs|Informing endoscopists of the number of accessories used and the dollar value of the accessories
16077504|NCT02327988|Other|Cryotherapy|
16077505|NCT02327988|Device|Laser therapy|
16077555|NCT02327650|Procedure|The examinations for bones in joints of OA and RA patients|
16077506|NCT02327975|Other|Training group|"The main part of the session included a whole-body strength training, which incorporated chest press, shoulder press, lateral pull-down, seated row, shoulder flexion, chest pulley, hammer curl, biceps curl, triceps curl, triceps pushdown, leg extension, leg curl, lunge, squat, abdominal crunch. To control and equate the intensity between the TG and MG, a method based on the combined use of the prescribed number of repetitions and the OMNI Resistance Scale for the active muscles was used. Previous studies have described the method used for controlling exercise intensity (Colado et al., 2012; Colado et al., 2014).
~During 1-3 weeks subjects performed 25 min of exercise at 60% maximum heart rate (HRmax), during weeks 4-6 subjects performed 30 min of exercise at 70% HRmax and during weeks 7-10 subjects performed 35 min of exercise at 80% HRmax."
16077507|NCT02327975|Other|Mobile group|The subjects in this group received the same intervention that trainning group but through a mobile application (whatsapp).
16077508|NCT02327975|Other|Control group|No received intervention.
16077509|NCT02327949|Device|W-Shaped Angular Plate|Treatment of posterior wall fracture of the acetabulum with a W-Shaped Angular Plate
16077510|NCT02327949|Device|Reconstruction Plate|Treatment of posterior wall fracture of the acetabulum with a Reconstruction Plate
16077511|NCT02327936|Drug|Fesoterodine|Administer medication to patients with overactive bladder
16077512|NCT02327936|Drug|Oxybutynin XL|Administer medication to patients with overactive bladder
16077513|NCT02327923|Drug|Lidocaine|Lidocaine intravenous 1.5mg/kg IV bolus at the time of induction followed by IV infusion @ 1.5 mg/kg/hr till the last suture.
16077514|NCT02327923|Drug|Esmolol|Esmolol intravenous bolus 0.5 mg/kg at the time of induction followed by infusion @ 5-15 microgram/kg/min till the last suture.
16077515|NCT02327923|Drug|Paracetamol|Inj. Paracetamol 1 gm IV at the time of induction
16077516|NCT02327923|Drug|Lidocaine|Inj. Xylocaine 2% 3 ml will be infiltrated in skin in all port sites prior to incision.
16077517|NCT02327923|Drug|Propofol|Inj. Propofol 2- 2.5 mg/kg will be given for induction
16077518|NCT02327923|Drug|Fentanyl|Inj fentanyl 1.5mg/kg will be given at the time of induction.
16077519|NCT02327923|Drug|Vecuronium|Inj Vecuronium 0.1mg/kg will be given at induction and for maintenance.
16077520|NCT02327923|Drug|Atropine|Inj Atropine 0.4 mg IV will be given for bradycardia (HR < 50/min)
16077521|NCT02327923|Drug|Ephedrine|
16077522|NCT02327923|Drug|Morphine|
16077523|NCT02327923|Drug|Ketorolac|
16077524|NCT02327923|Drug|Ondansetron|
16077525|NCT02327923|Drug|Bupivacaine|Inj. Bupivacaine 0.25% 10 ml will be infiltrated at incision site after closure.
16077526|NCT02327923|Drug|Tramadol|Inj tramadol 50 mg IV will be given on SOS basis in ward.
16077527|NCT02327923|Drug|Neostigmine|50 mcg/kg for reversal of residual neuromuscular blockade
16077528|NCT02327923|Drug|Glycopyrrolate|10 mcg/kg with neostigmine
16077529|NCT02327910|Other|TOF unit TcPCO2 group|The patients of U group were extubated when TOF ratio greater than 0.9 and TcPCO2 recovery to preoprative(±5mmHg)
16077530|NCT02327910|Other|TOF group|The patients of T group were extubated when TOF ratio greater than 0.9.
16077531|NCT02327871|Device|Esophageal cooling device (and usual standard procedure)|Standard treatments for resuscitation after CA will follow local, national, and international guidelines. Core temperature is measured using urinary Foley catheters and/or arterial temperature monitoring if available. During TH, sedation and analgesia is performed in routine. Neuromuscular blockade is induced to favor cooling and prevent shivering if necessary. Circulatory function is monitored by arterial catheter if necessary and blood pressure is maintained as usually. Hypotension is treated with dobutamine catecholamines titrated according cardiac output monitored using echocardiogram, or PiCCO® systems. Fluid management is left at the discretion of the attending physician. Prognostication after CA uses serial clinical examinations, biomarkers, transcranial Doppler, Electro-Encephalo-Gram, cerebral CT-scan or MRI, and/or Somato-Sensory-Evoked-Potential.
16077532|NCT02327858|Other|Supportive text messages|Patients in all the intervention groups will receive twice daily supportive SMS text messages for 3 months. The messages will be tailored towards improving mood, compliance with medication or targeting abstinence from alcohol in accordance with the primary aims of our study. As far as possible, the majority of the text messages will reflect lessons patients usually learn during CBT and addiction counselling sessions.
16077533|NCT02327832|Procedure|Autologous BMSCs|Cultured autologous bone marrow-derived mesenchymal stem cells
16077534|NCT02327832|Drug|bone marrow-derived mesenchymal stem cells|
16077535|NCT02327819|Dietary Supplement|Branched-chain amoni acids (BCAA)|
16077536|NCT02327819|Dietary Supplement|non-BCAA protein supplement|
16077537|NCT02327806|Device|pulsed electromagnetic field therapy|
16077538|NCT02327793|Drug|Nitroglycerin|
16077539|NCT02327793|Drug|Labetalol|
16077540|NCT02327780|Other|FODMAP diet|
16077541|NCT02327767|Device|Resonating Arm Exerciser|Participants in the exercise group will exercise using the device for 8 exercise sessions for 45 minutes per session for 3 consecutive weeks.
16077542|NCT02327754|Drug|Topiroxostat BID, (Oral daily dosing for 28 weeks)|The dose of topiroxostat is increased up to 160 mg/day in a stepwise manner.
16077543|NCT02327754|Drug|Placebo BID, (Oral daily dosing for 28 weeks)|Subjects randomized to the placebo arm will receive placebo.
16077544|NCT02327741|Drug|plavix|taking plavix more than 12 months
16077545|NCT02327741|Drug|plavix|taking plavix less than 12 months
16077546|NCT02327728|Procedure|Botulinum toxin A injection (5 sites: 12.5U)|
16077547|NCT02327728|Procedure|Botulinum toxin A injection (4 sites: 10U)|
16077548|NCT02327728|Drug|Botulinum toxin A 12.5U|
16077549|NCT02327728|Drug|Botulinum toxin A 10U|
16077550|NCT02327715|Drug|Emtricitabine|emtricitabine were given to each patients from week 28 pregnancy to 24 weeks after delivery
16077551|NCT02327702|Drug|Emtricitabine|emtricitabine were given to each patients at baseline till 48 weeks after delivery
16077552|NCT02327689|Drug|Emtricitabine plus adefovir dipivoxil|emtricitabine plus adefovir dipivoxil were given to each patients for 96 weeks
16077553|NCT02327676|Drug|Emtricitabine|emtricitabine were given to each patients for 48 weeks
16077554|NCT02327663|Drug|Emtricitabine|emtricitabine were given to each patients at baseline and respoonse guided therapy was adopted according HBV DNA level at week 24
16077556|NCT02327637|Behavioral|Moderate Activity|Ambulation 150 feet, two times per day
16077557|NCT02327624|Drug|Clopidogrel|Compare Clopidogrel to two doses of Ticagrelor 60 and 90
16077558|NCT02327624|Drug|Ticagrelor 60|Compare Clopidogrel to two doses of Ticagrelor 60 and 90
16077559|NCT02327624|Drug|Ticagrelor 90|Compare Clopidogrel to two doses of Ticagrelor 60 and 90
16077560|NCT02327611|Drug|Custodiol|
16077561|NCT02327611|Drug|Enriched Ringer's lactate solution|
16077562|NCT02327585|Behavioral|A randomized controlled study of Executive Function training for children with ADHD|Children diagnosis of ADHD are randomized to the experimental condition(Executive Function therapy) or waiting group experimental:participants will receive 12 sessions of executive function therapy weekly no intervention :waiting participants will not be treated with executive function therapy and keep waiting for 12 weeks for comparison
16077563|NCT02327559|Behavioral|Mind in Labor (MIL): Working with Pain in Childbirth|The Mind in Labor (MIL) mindfulness intervention for pregnant women and their partners integrates mindfulness strategies for coping with labor pain and fear and formal mindfulness meditation with traditional childbirth education. The MIL intervention is held over 3 consecutive weekend days (Friday - Sunday) for a total of 16 hours of mindfulness skills training for childbirth preparation and labor pain management. Mindfulness strategies for coping with labor-related pain and fear are taught in an interactive, experiential format, with periods of didactic instruction.
16077564|NCT02327559|Behavioral|Treatment as usual (TAU)|"The treatment as usual TAU active comparison condition includes participation in a standard care childbirth education course, chosen by participants in the TAU arm from a pre-approved list of hospital- and community-based childbirth education courses comparable in length and quality to MIL, but without any mindfulness meditation, mindful movement/yoga, or other core mind/body component (e.g., hypnosis)."
16077565|NCT02327546|Drug|AKB-6548|
16077566|NCT02327546|Drug|Ferrous Sulfate|
16077567|NCT02327520|Other|Colitis with CDI treatment|All patients will be treated with standard treatment
16077568|NCT02327507|Behavioral|Toothpaste & Telephone Support|Mailed toothpaste, messages and telephone support.
16077569|NCT02327494|Drug|neuromuscular blockade|to determine the influence on oxygantion saturation parameters of the administration of neuromuscular blockade drug, rocuronio, to provide intense neuromuscular blockade during laparoscopic colorectal surgery
16077570|NCT02327481|Procedure|3D Laparoscopic Surgery|After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy,3D laparoscopic gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.
16077571|NCT02327481|Procedure|2D Laparoscopic Surgery|After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy,2D laparoscopic gastrectomy will be performed with curative treated intent. The type of reconstruction will be selected according to the surgeon's experience.
16077572|NCT02327455|Procedure|Stress Dobutamine Echocardiographic using 4DE System|Subjects will undergo their clinically indicated stress dobutamine echocardiographic studies using our standard clinical graded dobutamine stress imaging protcol, employing the iE33 4DE system.
16077573|NCT02327442|Radiation|68Ga-NOTA-NFB|In this investigation, 68Ga-NOTA-NFB is employed to a preclinical trial, including radiation dosimetry study in healthy volunteers and the first application in glioma patients, to assess the safety, dosimetry property and evaluate the CXCR4 expression in glioma patients and breast cancer patients.
16077574|NCT02327429|Behavioral|A Chinese menu plan for type 2 diabetes|The intervention is a menu plan, recipes and tips on healthy eating delivered one-on-one between the participant and the facilitator. There will be 4 such one-on-one meetings. The goal is to facilitate behaviour change that results in a healthier diet.
16077575|NCT02327416|Drug|Y peginterferon alfa-2b|In arm 2 and 3, Y peginterferon alfa-2b is used for 96 weeks
16077576|NCT02327416|Drug|Granulocyte-macrophage colony stimulating factor|In arm 3, Granulocyte-macrophage colony stimulating factor is used for 48 weeks intermittently
16077577|NCT02327416|Drug|Entecavir and or adefovir dipivoxil|In arm 1, Entecavir and or adefovir dipivoxil are used for 96 weeks and the follow up 24 weeks as conventional control, In arm 2 and 3, Entecavir and or adefovir dipivoxil are used for 48 weeks.
16077578|NCT02327403|Drug|Belatacept|Conversion from calcineurin-inhibitor to Belatacept maintenance immunosuppression.
16077579|NCT02327390|Procedure|lymph node|Undergo surgery to remove a melanoma-draining lymph node for generation of X-ACT cells in the laboratory
16077580|NCT02327390|Biological|X-ACT|Administered as an IV infusion
16077581|NCT02327377|Behavioral|Online Cognitive Behavior Therapy|
16077582|NCT02327377|Behavioral|Online Education|
16077583|NCT02327351|Other|Biological: TCR alfa beta T cell depletion|
16077584|NCT02327338|Device|thermacare heat wraps|off the shelf thermacare continuous heat wraps made by thermacare to produce low level heat on the neck
16077585|NCT02327338|Drug|Ibuprofen|1200 mg ibuprofen administered 400mg at 4 hour intervals
16077586|NCT02327325|Behavioral|Physical Activity|12-week home-based physical activity program with telephone support. Delivered by a physical therapist and exercise counselor. Comprehensive program including stretching, strengthening and aerobic activity.
16077587|NCT02327325|Behavioral|Cognitive Behavioral Therapy|Telephone-based training in multiple skills for managing low back pain.
16077588|NCT02327312|Device|Stents|Two Trabecular meshwork Micro-Bypass stents into the study eye
16077589|NCT02327312|Procedure|Laser|Laser Trabeculoplasty
16077590|NCT02327312|Device|Laser Trabeculoplasty|
16077591|NCT02327299|Dietary Supplement|Bouillon fortified with FePP|
16077592|NCT02327299|Dietary Supplement|Bouillon fortified with FePP + Stabilizer|
16077593|NCT02327299|Dietary Supplement|Bouillon fortified with FeSO4|
16077594|NCT02327299|Dietary Supplement|Bouillon fortified with FeSO4 + Stabilizer|
16077649|NCT02326961|Device|Celution Device|ADRCs Prepared using the Celution Device
16077650|NCT02326961|Other|Placebo|Inactive Placebo
16077651|NCT02326935|Biological|Autologous adipose derived mesenchymal cells|Autologous adipose derived mesenchymal cells, 150M cells deployed via two (2) treatments via intravenous injection.
16077652|NCT02326922|Device|Metraplant-E levonorgestrel-releasing intrauterine device|Metraplant-E insertion and follow up for 6 months
16078123|NCT02323204|Behavioral|Link for Injured Kids|Psychological First Aid
16077595|NCT02327286|Behavioral|Promote and support healthy behaviors|"Exclusive breastfeeding for 6 months and partial breastfeeding for at least 3 additional months.
~Personally monitored weight loss and maintenance with goal: return to pre-pregnancy weight and, if overweight pre-pregnancy, loss of an additional 5% of body weight.
~Healthy eating: avoidance of ultra-processed foods, limited intake of oils, sugars and processed foods, increased intake of foodstuffs in their natural state, regular intake of water, dairy products, unsweetened coffee and tea.
~A progressive increase in physical activity of at least 150 minutes of moderate or vigorous physical activity/week (7500 steps/day) and reduction of sedentary behavior with monitoring by personally worn devices."
16077596|NCT02327273|Drug|BMS-963272|
16077597|NCT02327273|Drug|Placebo|
16077598|NCT02327260|Behavioral|Video + Motivational interview for CR participation|Patients will be shown a 9 minute video that highlights actual CR patients discussing barriers they overcame to participate in CR, and introductions to the CR staff. The brief, phone-based motivational interview will focus on increasing motivation to participate in CR.
16077599|NCT02327260|Behavioral|Motivational interview for medication adherence|The brief, phone-based motivational interview will focus on increasing motivation to adhere to prescribed cardioprotective medications.
16077600|NCT02327247|Drug|Felodipine|Extended Release Tablets, 10mg
16077601|NCT02327247|Drug|PLENDIL®|Extended Release Tablets, 10mg
16077602|NCT02327234|Drug|ibuprofen|2x 200mg ibuprofen, single dose, blinded in 00 capsules
16077603|NCT02327234|Drug|Placebo|lactose filled 00 capsules to match appearance of ibuprofen intervention
16077604|NCT02327221|Drug|Ovasave|During CATS29-Double blind phase, two intravenous administrations of study drug will be administered, one at week 0 and another one at week 8.
16077605|NCT02327221|Drug|Placebo|During CATS29-Double blind phase, two intravenous administrations of study drug will be administered, one at week 0 and another one at week 8.
16077606|NCT02327208|Dietary Supplement|Control|
16077607|NCT02327208|Dietary Supplement|Protein|
16077608|NCT02327208|Dietary Supplement|Carbohydrate|
16077609|NCT02327195|Drug|Methylphenidate HCl|Subjects will be randomly assigned to either the Methylphenidate or the Placebo arm, and be given a 20 mg dose (of Methylphenidate or Placebo) in liquid form (4 mL)
16077610|NCT02327195|Drug|Placebo|20 mg of placebo (PO) will be given 2 hours prior to surgery
16077611|NCT02327182|Drug|MT-4666|
16077612|NCT02327169|Drug|MLN2480|MLN2480 tablets.
16077613|NCT02327169|Drug|MLN0128|MLN0128 capsules.
16077614|NCT02327169|Drug|Alisertib|Alisertib tablets.
16077615|NCT02327169|Drug|Paclitaxel|Paclitaxel IV infusion.
16077616|NCT02327169|Drug|Cetuximab|Cetuximab IV infusion.
16077617|NCT02327169|Drug|Irinotecan|Irinotecan IV infusion.
16077618|NCT02327156|Drug|dexmedetomidine|adding dexmedetomidine to the local anesthetic
16077619|NCT02327143|Drug|LY2835219|Administered orally
16077620|NCT02327143|Drug|¹³C₈-LY2835219|Administered IV
16077621|NCT02327130|Device|Isomark Canary™|Isomark, LLC is a Madison, Wisconsin-based company that has developed an investigational device, the Isomark Canary™, that is intended to determine the breath delta value of breath samples collected from critically ill patients.
16077622|NCT02327117|Drug|Tranexamic Acid|
16077623|NCT02327117|Drug|Normal saline|
16077624|NCT02327104|Behavioral|Mindfulness Based Relapse Prevention|The MBRP is an adjuvant treatment for people that have been treated for drug use related problems, and to prevent relapses.
16077625|NCT02327104|Other|Brazilian Ministry of Health Protocol|The control group will receive maintenance sessions based on the Ministry of Health protocol after the four sessions of cognitive-behavioral approach.
16077626|NCT02327091|Drug|alfacalcidol|One group of 47 subjects received alfacalcidol 0.5 mcg/day and the other group received placebo
16077627|NCT02327078|Drug|Nivolumab (Phase 1)|specified dose and dosing schedule
16077628|NCT02327078|Drug|Epacadostat (Phase 1)|oral twice daily continuous at the protocol-defined dose
16077629|NCT02327078|Drug|Chemotherapy (Phase 1)|Specified dose on specified days
16077630|NCT02327078|Drug|Nivolumab (Phase 2)|specified dose and dosing schedule
16077631|NCT02327078|Drug|Epacadostat (Phase 2)|oral twice daily continuous at the protocol-defined dose
16077632|NCT02327065|Device|EUS-FNA (EchoTip Ultra)|FNA,Fine needle aspiration
16077633|NCT02327065|Device|EUS-FNB (EchoTip ProCore)|FNB,Fine needle biopsy
16077634|NCT02327052|Other|No intervention was performed.|No intervention was performed.
16077635|NCT02327039|Drug|Dapagliflozin|Sodium glucose cotransporter-2 inhibitor
16077636|NCT02327039|Drug|Placebo|Tables of Dapagliflozin placebo
16077637|NCT02327026|Procedure|bag-valve-mask ventilation|Airway management including initial bag-valve-mask ventilation by the medical team during OHCA. When standard bag-valve-mask ventilation is possible, the patient will be intubated in case of a return of spontaneous circulation. When standard bag-valve-mask ventilation is impossible or in case of massive regurgitation of gastric content (after randomisation), intubation of patient is the preferred alternative.
16077638|NCT02327026|Procedure|tracheal intubation|Tracheal intubation during OHCA by the medical team: The standard intubation procedure is to use a non-styletted tube and no sedation. When standard laryngoscopy-assisted intubation is not possible, an alternate procedure will be used based on the French consensus conference guidelines on difficult airway management
16077639|NCT02327013|Drug|vortioxetine 10 mg tablet|Oral tablets, once daily
16077640|NCT02327013|Drug|vortioxetine 20 mg tablet|Oral tablets, once daily
16077641|NCT02327013|Other|Placebo tablet|Oral tablets, once daily
16077642|NCT02327000|Drug|Pregabalin 150mg|GLA5PR GLARS-NF1 tablet 150mg/day(Pregabalin 150mg once a day)
16077643|NCT02327000|Drug|Pregabalin 300mg|GLA5PR GLARS-NF1 tablet 300mg/day(Pregabalin 300mg once a day)
16077644|NCT02326987|Drug|Pregabalin 150mg|GLA5PR GLARS-NF1 tablet 150mg/day(Pregabalin 150mg once a day)
16077645|NCT02326987|Drug|Pregabalin 75mg|Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day)
16077646|NCT02326974|Drug|T-DM1|Neoadjuvant treatment is for a total of 18 weeks.
16077647|NCT02326974|Drug|Pertuzumab|Neoadjuvant treatment is for a total of 18 weeks.
16077648|NCT02326974|Procedure|Excision of tumor/mastectomy|Definitive breast cancer surgery (excision or mastectomy) marks the end of protocol mandated therapy.
16077653|NCT02326909|Device|Optical Coherence Tomography|Single Optical Coherence Tomography measurement of upper urinary tract tumour taken during ureterorenoscopy
16077654|NCT02326909|Device|Optical Coherence Tomography|A single 1300 nm OCT measurement will be performed during ureterorenoscopy in patients with upper urinary tract tumour(s)
16077658|NCT02326870|Device|AutoLap|
16077659|NCT02326844|Drug|BMN 673 (talazoparib)|1 mg by mouth (p.o.) once daily on 28-day cycles until disease progression
16077660|NCT02326805|Other|Laboratory Biomarker Analysis|Correlative studies
16077661|NCT02326805|Other|Placebo Administration|Given SC
16077662|NCT02326805|Biological|Rilimogene Galvacirepvec|Given SC
16077663|NCT02326792|Other|Exercise|The groups will perform the trunk extensor exercise on a roman chair by 2 x week, for a total of 10 weeks of training (20 sessions). The load will be progressive and tested to each 14 days with regard to the number of repetition reached by the participant. The exercise is safe and will be supervised by a health sport professional.
16077664|NCT02326779|Drug|Acetylsalicylic acid|Acetylsalicylic acid (Aspirin) 100 mg OD for 3 years
16077665|NCT02326766|Dietary Supplement|KRG|5g Korea red ginseng (KRG)
16077666|NCT02326766|Dietary Supplement|Placebo|5g placebo
16077667|NCT02326753|Device|No. 7 oral airway|the use of 7 cm sized-oropharyngeal airway (Guedel-type color coded oropharyngeal airway, Hudson RCI, Teleflex Medical, Research Triangle Park, NC)
16077668|NCT02326753|Device|No. 8 oral airway|the use of 8 cm sized-oropharyngeal airway (Guedel-type color coded oropharyngeal airway, Hudson RCI, Teleflex Medical, Research Triangle Park, NC)
16077669|NCT02326753|Device|No. 9 oral airway|the use of 9 cm sized-oropharyngeal airway (Guedel-type color coded oropharyngeal airway, Hudson RCI, Teleflex Medical, Research Triangle Park, NC)
16077670|NCT02326740|Drug|gevokizumab|
16077671|NCT02326740|Drug|Placebo|
16077672|NCT02326740|Drug|gevokizumab open-label|
16077673|NCT02326727|Drug|Ropivacaine|Epidural analgesia
16077674|NCT02326727|Drug|Fentanyl|General Anesthesia
16077675|NCT02326727|Drug|Propofol|General Anesthesia
16077676|NCT02326727|Drug|Isoflurane|General Anesthesia
16077677|NCT02326727|Drug|Nitrous Oxide|General Anesthesia
16077678|NCT02326714|Other|Auricular acupressure|The magnetic beads were taped to the auricular acupressure points, by the same acupuncture specialist on one ear approximately after skin sterilization, and the subjects were asked to massage the points for 5 minutes, 30 minutes before three meals and sleep.The magnetic beads were left in situ, but replaced with new ones once every week in the other ear.
16077679|NCT02326714|Other|Placebo auricular acupressure|The magnetic beads were taped to the auricular acupressure points, by the same acupuncture specialist on one ear approximately after skin sterilization, and the subjects were not asked to massage the points.The magnetic beads were left in situ, but replaced with new ones once every week in the other ear.
16077680|NCT02326688|Other|Kinematic analysis of trunk compensation|
16077681|NCT02326675|Other|Ice|This group will receive cryotherapy, saline rinses, an oral care diary will be completed by the subject, and a daily oral assessment will be performed by the investigators as part of their participation.
16077682|NCT02326675|Other|Normal Saline Solution|This group will receive saline rinses, an oral care diary will be completed by the subject, and a daily oral assessment will be performed by the investigators as part of their participation.
16077683|NCT02326662|Biological|Autologous Stem Cell Transplantation|Autologous neural stem cell transplantation Stem Cell Transplantation by intraspinal and intrathecal injection with 3D matrix as needed
16077684|NCT02326649|Device|Physioflow|impedance cardiography instrument that measures cardiac output non-invasively
16077685|NCT02326636|Biological|Fecal Microbial Transplantation|Participants with refractory Clostridium difficile infection will be given healthy donor stool administered by colonoscopy or enema.
16077686|NCT02326623|Other|distraction|distraction using an iPad with a selection of child-appropriate games
16077687|NCT02326623|Other|topical anesthetic cream|standard care is to use a topical anesthetic cream at the site of planning IV access
16077688|NCT02326610|Drug|Human growth hormone,ZOMACTON® (somatropin)|The initial dose will be 30µg/kg/day. The maximal dose will be 40µg/kg/day. The dose will be adjusted by monitoring the serum IGF-I level. Growth hormone will be delivered by injection.
16077689|NCT02326597|Other|Decision Aid Tool|The tool is a web based decision aid that provides information about the risks and benefits associated with sickle cell disease therapies. Participants will be provided a unique access ID and password to access the information.
16077690|NCT02326597|Other|Standard Practice|Standard of care teaching and discussion regarding treatment options given by patient's healthcare provider.
16077691|NCT02326584|Drug|Standard dose cytarabine for induction|100 mg/m2/day Days 1-7
16077692|NCT02326584|Drug|SGN-CD33A|Given intravenously Day 1 or Days 1 and 4 of each cycle
16077693|NCT02326584|Drug|Daunorubicin|60 mg/m2/day Days 1-3
16077694|NCT02326584|Drug|High dose cytarabine for consolidation|3g/m2 on Days 1, 3, and 5 of each cycle
16077695|NCT02326558|Procedure|laparoscopic microwave ablation-assisted enucleation|
16077696|NCT02326558|Procedure|conventional laparoscopic partial nephrectomy|
16077697|NCT02326545|Behavioral|MindLight|MindLight is a video game that uses neurofeedback as part of game mechanics. Participants play for 5 hours total over 3 weeks. Measures taken pre, post, and 3-month follow-up.
16077698|NCT02326545|Behavioral|Online CBT|Five sessions of power point slides that cover primary concepts and homework of cognitive behavioral therapy. Adapted for children. Measures taken pre, post, and 3-month follow-up.
16077699|NCT02326532|Other|PRO data utilized|Data collected from a patient-completed MDHAQ/RAPID3 questionnaire is provided to the treating physician.
16077700|NCT02326532|Other|PRO data not utilized|Data collected from a patient-completed MDHAQ/RAPID3 questionnaire is not provided to the treating physician.
16077701|NCT02326519|Other|Intracardiac electrode catheter|All patient in the study will have the same data collected using the Steerable intracardiac electrode catheter
16077702|NCT02326506|Device|VA-ELS pump speed variations|Small variations in the pump speed of the veno-arterial extracorporeal life support (VA-ELS) pump
16077703|NCT02326493|Device|Cardiac Resynchronization Therapy|A CRT device will be implanted while performing extra hemodynamic (LV dP/dtmax) and electrical (LVLED, VCG, and D-VCG) measurements. Devices and leads from various vendors will be used.
16077704|NCT02326480|Other|Identification of genetic causes of obesity|A blood test will be performed to the child and his/her parents with the aim of identifying genetic causes of obesity. Different analysis will be as follows: caryotypes, Raindance, whole exome, in order to find potential mutations or new genes associated to this condition
16077705|NCT02326467|Drug|Chlorhexidine gluconate|Bi-weekly chlorhexidine baths
16077706|NCT02326454|Drug|talaporfin sodium|1 mg/kg
16077707|NCT02326454|Drug|Saline|
16077708|NCT02326454|Device|Drug Activator 100 J/cm|Light Dose: 100 J/cm
16077709|NCT02326454|Device|Drug Activator 200 J/cm|Light Dose: 200 J/cm
16077710|NCT02326441|Drug|KX2-361|
16077711|NCT02326428|Device|Stent retriever endovascular device for thrombectomy|Thrombectomy by selected stent retrievers (TREVO, Solitaire, pREset, in special cases all stent retrievers) as additional therapy in major artery occlusion in patients fulfilling criteria for and receiving intravenous thrombolysis
16077712|NCT02326428|Drug|Intravenous thrombolysis by alteplase (Actilyse) (optional)|Stroke thrombolysis with Alteplase (Boeringer-Ingelheim, ATC-code B01AD02; a fibrinolytic drug) according to conventional guidelines (0.9 mg/kg, not exceeding 90 mg, given intravenously)
16077713|NCT02326415|Other|"Clinical Pathway with Fast-Track"|Care described in the critical pathway during postoperative like the moment when the patients can eat, can move or are discharged.
16077714|NCT02326415|Other|Postoperative Usual Protocol|Cares step by step as sugery responsable thinks are the best for patients until discharge.
16077715|NCT02326402|Device|TandemHeart or LifeSPARC System|Percutaneous insertion of TandemHeart or LifeSPARC System
16077716|NCT02326389|Behavioral|Exercise|The exercise intervention is a 10-week program involving 40 minutes of aerobic exercise targeting 60-75% of maximum heart rate on 3 days each week, with an additional 5-minute stretching warm up and cool down.
16077717|NCT02326389|Behavioral|Cognitive Remediation|Participants will be engaged in 30 hours of computer-based cognitive exercises with a standardized, widely used software package (Cogpack, Version 7.0, Marker Software), shown to improve cognitive functioning in multiple studies. One-hour sessions will be conducted 3 times per week for 10 weeks.
16077718|NCT02326376|Drug|anakinra (Kineret)|
16077719|NCT02326363|Behavioral|Mindfulness Based Relapse Prevention (MBRP)|Each session has a central theme/topic and consists of in-session experiential practice, discussions and homework assignments. Sessions begin with a check-in followed by a 20-30 minute meditation (i.e. body scan). The therapist reviews homework assignments, discusses challenges and participants are taught a variety of MM practices such as breath meditation, urge surfing, walking or movement meditation.
16077720|NCT02326363|Behavioral|Twelve-Step Facilitation Intervention (TSF)|"The primary goal is to promote abstinence by facilitating the patient's acceptance and surrender of addiction. Sessions begin with a check-in during which participants introduce themselves, report on meeting attendance and participation in related activities, any alcohol/drug use or craving to use. The remainder of the session focuses on discussion of the topic content followed by a take home summary and homework assignment."
16077721|NCT02326350|Drug|Aspirin 75mg|Active treatment
16077722|NCT02326350|Drug|Lactose powder|Placebo
16077723|NCT02326337|Device|TWO2 Device|Application of the Topical Wound Oxygen (TWO2) device that supplies cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
16077724|NCT02326337|Device|Placebo Device|Application of placebo device that does not supply cyclical oxygen pressure directly to the wound site within a sealed and humidified environment for 90 minutes, 5 times a week with AMWT dressings.
16077725|NCT02326311|Drug|imatinib|Tyrosin kinase inhibitor
16077726|NCT02326311|Drug|nilotinib|Tyrosin kinase inhibitor
16077727|NCT02326311|Drug|dasatinib|Tyrosin kinase inhibitor
16077728|NCT02326298|Biological|Certolizumab Pegol|"Active Substance: Certolizumab Pegol
~Pharmaceutical Form: Solution for injection in pre-filled syringe
~Concentration: 200 mg/mL
~Route of Administration: Subcutaneous use"
16077729|NCT02326298|Other|Placebo|"Active Substance: Placebo
~Pharmaceutical Form: Solution for injection in pre-filled syringe
~Concentration: 0.9 % saline
~Route of Administration: Subcutaneous use"
16077730|NCT02326285|Drug|Gefitinib|Patients will be treated for 12 days with gefitinib 250 mg/day p.o. (d -12 to -1) and induced with chemotherapy docetaxel 75 mg/m2 and cisplatin 50 mg/m2 d1+2 and intercalated gefitinib 250 mg/day d4-20 (cycle 1 and 2) and d4-17 (for cycle3). Surgery is planned in the 4th week after d1 of the last cycle.
16077731|NCT02326285|Drug|docetaxel|chemotherapy docetaxel 75 mg/m2 and cisplatin 50 mg/m2 d1+2 and intercalated gefitinib 250 mg/day d4-20 (cycle 1 and 2) and d4-17 (for cycle3).
16077732|NCT02326285|Drug|cisplatin|chemotherapy docetaxel 75 mg/m2 and cisplatin 50 mg/m2 d1+2 and intercalated gefitinib 250 mg/day d4-20 (cycle 1 and 2) and d4-17 (for cycle3).
16077733|NCT02326285|Procedure|Surgery|Surgery should be performed in the 4th or at the latest 5th week after d1 of the last cycle of chemotherapy (d64 to 78).
16077734|NCT02326272|Biological|Certolizumab Pegol|"Active Substance: Certolizumab Pegol
~Pharmaceutical Form: Solution for injection in pre-filled syringe
~Concentration: 200 mg/mL
~Route of Administration: Subcutaneous use"
16077735|NCT02326272|Other|Placebo|"Active Substance: Placebo
~Pharmaceutical Form: Solution for injection in pre-filled syringe
~Concentration: 0.9 % saline
~Route of Administration: Subcutaneous use"
16078002|NCT02324114|Device|Hsp90|Detect plasma Hsp90α concentration
16077736|NCT02326259|Other|Initiation of treatment of diabetes|Treatment of diabetes according to the standard of care.
16077737|NCT02326246|Other|multi-parametic MRI|
16077738|NCT02326233|Biological|Pen of SB5|
16077739|NCT02326233|Biological|PFS of SB5|
16077740|NCT02326220|Drug|Placebo|
16077741|NCT02326220|Drug|Alirocumab|
16077742|NCT02326207|Device|Infant Ventilator Circuit Dual Heated with Autofeed Chamber|
16077743|NCT02326194|Biological|Low dose Ebola Zaire vaccine (Ad5-EBOV)|one dose, Low dose Ebola Zaire vaccine (Ad5-EBOV)
16077744|NCT02326194|Biological|High dose Ebola Zaire vaccine (Ad5-EBOV)|two doses, High dose Ebola Zaire vaccine (Ad5-EBOV), with one dose to each arm at a same time.
16077745|NCT02326194|Biological|placebo (one dose)|placebo, one doses
16077746|NCT02326194|Biological|placebo (two doses)|placebo, two doses, with one dose to each arm at a same time.
16077747|NCT02326181|Device|inspiratory pressure training group|The respiratory pressure load device can be provided different loads to perform inspiratory and expiratory pressure training.In the study,pressure-threshold respiratory trainers were calibrated to provide different loads against inspiration (IMST) .
16077748|NCT02326181|Device|mixed training group|The respiratory pressure load device can be provided different loads to perform inspiratory and expiratory pressure training.In the study,pressure-threshold respiratory trainers were calibrated to provide different loads against inspiration (IMST) and expiration(EMST).
16077749|NCT02326168|Drug|Bacillus Calmette-Guerin (BCG)|Intravesical instillation for non-muscle invasive bladder cancer
16077750|NCT02326142|Drug|OBE001|OBE001 dispersible tablets for a single oral dose a day for up to 7 days.
16077751|NCT02326142|Drug|Placebo|Placebo dispersible tablets for a single oral dose a day for up to 7 days.
16077752|NCT02326116|Other|Trachael Preparation Education|
16077753|NCT02326103|Drug|Ciprofloxacin|Comparison of ciprofloxacin with placebo in alcoholic hepatitis
16077754|NCT02326103|Drug|Placebo|
16077755|NCT02326090|Drug|cis-UCA ophthalmic solution 1.0%|
16077756|NCT02326090|Drug|cis-UCA ophthalmic solution 2.5%|
16077757|NCT02326090|Drug|Placebo ophthalmic solution|
16077758|NCT02326077|Other|Ultrasound|Monitoring of the mechanism of labor
16077759|NCT02326077|Other|Acceptability of ultrasound monitoring of labor|Evaluation of the acceptability of intrapartum ultrasound monitoring - the rate of uptake ultrasound protocol during labor
16077760|NCT02326077|Other|Patients' experience regarding intrapartum ultrasound|The day after birth, consenting women are invited to take part in a questionnaire survey. Questionnaires contained no identifying information other than a code number and contains features regarding the patient's impression about the ultrasound monitoring scans during labor. The final questions concerned the willingness of having again another such protocol for labor monitoring in the future.
16077761|NCT02326051|Drug|Enoxaparin|Women will start Enoxaparin therapy in a dose of 40 mg/day subcutaneously once positive pregnancy test is established and the therapy will continue until termination of pregnancy
16077762|NCT02326051|Drug|Enoxaparin|Women will start Enoxaparin therapy in a dose of 40 mg/day subcutaneously after sonographic confirmation of fetal cardiac pulsation and the therapy will continue until termination of pregnancy
16077763|NCT02326038|Drug|Methylphenidate|single oral administration of 20 mg tablet
16077764|NCT02326025|Drug|Olaratumab|Administered IV
16077765|NCT02326025|Drug|Doxorubicin|Administered IV
16077766|NCT02326012|Behavioral|Emotion Regulation Individual Therapy for Adolescents|
16077767|NCT02325999|Procedure|ESD AND LRLD|A new therapy for gastric cancer : Endoscopic Submucosal Dissection combine with Laparoscopic Regional Lymph node Dissection.
16077768|NCT02325986|Drug|fluorouracil|cisplatin 25mg/m2 on day 1, fluorouracil 1176mg/m2 on day 1-3，repeated weekly for 4 weeks concurrently with IMRT radiotherapy (60Gy/28fr)
16077769|NCT02325986|Drug|Cisplatin|cisplatin 25mg/m2 on day 1, fluorouracil 1176mg/m2 on day 1-3，repeated weekly for 4 weeks concurrently with IMRT radiotherapy (60Gy/28fr)
16077770|NCT02325986|Radiation|Intensity-modulated radiation therapy|cisplatin 25mg/m2 on day 1, fluorouracil 1176mg/m2 on day 1-3，repeated weekly for 4 weeks concurrently with IMRT radiotherapy (60Gy/28fr)
16077771|NCT02325973|Device|PressureWire Certus guidewire|Assessment of IMR index in coronaries through PressureWire Certus guidewire
16077772|NCT02325960|Drug|exenatide|5 μg BID for the first 4 weeks of treatment and 10 μg thereafter.
16077773|NCT02325960|Drug|Insulin glargine|≥8 IU QD, and titrate based on a dosing algorithm targeting FPG <6.1 mmol/L. Titration is only allowed in first 4 weeks.
16077774|NCT02325947|Device|hand exoskeleton, brain-computer interface (BCI),|Hand exoskeleton, brain-computer interface (BCI) 10 sessions of 45-minutes
16077775|NCT02325947|Device|hand exoskeleton, sham BCI|Hand exoskeleton, sham BCI 10 sessions of 45-minutes (BCI imitation)
16077776|NCT02325934|Drug|Stribild|Elvitegravir, cobicistat, emtricitabine, tenofovir disoproxil
16077777|NCT02325934|Drug|Stribild, crushed|Crushed Stribild tablet
16077778|NCT02325921|Device|Magnetic Resonance Imaging|One MRI examination, diagnostic scanning protocol as used for renal tumours with additional diffusion weighted sequences, but without contrast enhancement.
16077779|NCT02325895|Other|Dried Plum|Three doses of dried plum (0 g, 50 g and 100g) were used as intervention.
16077780|NCT02325882|Drug|Dexmedetomidine|Dexmedetomidine mixed fentanyl based intravenous PCA
16077781|NCT02325882|Drug|Fentanyl 1|conventional fentanyl-based epidural PCA
16077782|NCT02325882|Drug|Fentanyl 2|conventional fentanyl based intravenous PCA
16077783|NCT02325869|Device|Bell Balloon Catheter|An angioplasty procedure to open the blockage in blood vessels will be performed. Standard angioplasty procedure includes local analgesia of the groin area and a small cut through which the procedure will be performed. An introducer sheath (thin tube) will be inserted. The Bell Balloon dilatation will then be inserted. The Bell Balloon works in fashion similar to standard balloon with the same physical and behavioral characteristics. Upon deflation, debris from the blockage is withdrawn into the cavity formed between the deflated balloon and its outer capsule. Then balloon is retracted and retrieved through the guiding catheter, together with the captured debris and trap it between the outer surface of the balloon and the inner surface of the membrane.
16078003|NCT02324101|Device|Hsp90|Detect plasma Hsp90α concentration
16078004|NCT02324088|Drug|Docetaxel|
16077784|NCT02325856|Device|Bioimpedance Spectroscopy|Bioimpedance Spectroscopy is a safe tool to evaluate the fluid status in hemodialysis patients.
16077785|NCT02325856|Behavioral|Clinical judgement|
16077786|NCT02325843|Other|human bone marrow MSC|The arms of active comparator :human bone marrow MSC subconjunctival injection once time. If persistent epithelial defect was noted thereafter, a second MSC injection was performed.
16077787|NCT02325830|Device|CARILLON Mitral Contour System|Percutaneous mitral valve repair
16077788|NCT02325817|Device|Drug-eluting balloon|Treat the side branch of bifurcation lesion with drug-eluting balloon
16077789|NCT02325817|Device|Uncoated ballloon|Treat the side branch of bifurcation lesion with uncoated balloon
16077790|NCT02325804|Behavioral|Lifestyle Counseling|In both arms life style counseling: Low calorie diet- 30% reduction of weight maintenance calories (TDEE); and recommended moderate exercise 3 times per week 45 minutes.
16077791|NCT02325791|Drug|Suptavumab 30 mg/kg|Participants received single dose of suptavumab 30 milligram per kilogram (mg/kg) intramuscularly (IM) on Day 1.
16077792|NCT02325791|Drug|Placebo Matched to Suptavumab|Participants received 2 IM doses of placebo matched to suptavumab: the first dose on Day 1 and the second dose on Day 57.
16077793|NCT02325791|Drug|Suptavumab 30 mg/kg- 1 Dose|Participants received single dose of suptavumab 30 mg/kg IM on Day 1 and single dose of placebo matched to suptavumab on Day 57.
16077794|NCT02325791|Drug|Suptavumab 30 mg/kg - 2 Doses|Participants received 2 doses of suptavumab 30 mg/kg IM: the first dose on Day 1 and the second dose on Day 57.
16077795|NCT02325778|Procedure|CTI ablation Timing|The timing of when the CTI ablation is performed. There are no other relevant interventions used in the procedure.
16077796|NCT02325752|Other|Intervention|"A multidisciplinary team delivered the transitional care program.
~Our transitional care program focused on four key areas:
~Post discharge surveillance of the patient to ensure adherence to care plans.
~Coordination of follow-up visits with specialist care providers.
~Patent education and care giver training.
~Activation of community and social services.
~Upon recruitment, the patients were interviewed and assessed by the team nurse prior to their discharge. Intervention starts upon discharge from the hospital. The duration of the intervention program was 3 months. A follow-up by telephone was made within 72 hours after discharge to assess patient's condition and adherence to treatment plan. Home visits were made within 2 weeks after discharge."
16077797|NCT02325739|Drug|FGF401|FGF401 is a FGFR4 inhibitor.
16077798|NCT02325739|Biological|PDR001|PDR001 is a humanized anti-PD1 IgG4 antibody that blocks the binding of PD-L1 and PD-L2
16077799|NCT02325726|Procedure|Renal Resistive Index compared with NephroCheckTM|
16077800|NCT02325713|Drug|Oral dispersible tablet of praziquantel (ODT-PZQ)|Treatment A (test): ODT-PZQ (MSC1028703A) at a single dose of 40 milligram per kilogram (mg/kg) orally dispersed in water after meal.
16077801|NCT02325713|Drug|Cysticide|Treatment B (reference): Cysticide tablet at a single dose of 40 mg/kg will be given with water orally after a meal.
16077802|NCT02325713|Drug|ODT-PZQ|Treatment C1 (test): ODT-PZQ (MSC1028703A) at a single dose of 20 mg/kg orally dispersed in water after a meal.
16077803|NCT02325713|Drug|ODT-PZQ|Treatment C2 (test): ODT-PZQ (MSC1028703A) at a single dose of 60 mg/kg orally dispersed in water after a meal.
16077804|NCT02325713|Drug|ODT-PZQ|Treatment D1 (test): ODT-PZQ (MSC1028703A) at a single dose of 40 mg/kg orally dispersed in water without a meal.
16077805|NCT02325713|Drug|Cysticide|Treatment D2 (reference): Cysticide crushed tablets at a single dose of 40 mg/kg will be given with water orally after a meal.
16077806|NCT02325700|Procedure|Aortic repair|Aortic bypass
16077807|NCT02325687|Procedure|Lumbar Puncture (Standard-of-Care)|All study patients will have previously consented to undergo either spinal or spinal-epidural anesthesia. Patients will undergo their planned spinal or combined spinal-epidural placement in the OR. At the time of confirmation of placement of the spinal needle (positive CSF flow), 5 mL CSF will be collected and stored. CSF will be drawn using a standard 25g or 27g needle commonly used for anesthesia. The volume of CSF removed will be replaced with 4 cc local anesthetic (1.5% mepivacaine for spinal anesthesia).
16077808|NCT02325661|Other|cognitive interviewing|"For the individual cognitive interviews we are using the two techniques to think aloud and the verbal probing. To think aloud means, that the patients are asked to express precisely what comes to their mind when reading the single questions. This means, the interviewer is interested in the line of thoughts, which arise when reading the question. Thereby, the problems which appear in the usually covert process of answering a question should be revealed. In a second step, we are using the verbal probing technique to identify possible misunderstandings of the questions or difficulties with single phrases. The interviewer asks further questions that target the patients' interpretation."
16077809|NCT02325648|Drug|HIPEC cytoreductive surgery|At least 30 minutes prior to the prospective conclusion of the surgery, 1 μg/kg of fentanyl is administered for postoperative analgesia and 0.075mg of palonosetron is IV-infused for the prevention of nausea and vomiting. Desflurane and remifentanil administration is ceased after the surgery is concluded, muscle relaxation is evaluated by train of four (TOP) monitoring using a nerve stimulator, and the neuromuscular blockade is reversed with 0.2 mg of glycopyrrolate and 1 mg of neostigmine. When the patient recovers consciousness and begins spontaneous respiration, extubation is performed and the patient is transferred to the ICU with monitoring of their vital signs.
16077810|NCT02325635|Other|Educational Training|Intervention/Training offered to endoscopists only.
16077811|NCT02325596|Genetic|miRNA mimics or inhibitors|DCs are transfected by the miRNA mimics or inhibitors after they are separated from peripheral blood mononuclear cells in CRS patients
16077812|NCT02325583|Drug|30% Glucose|ORAL 30% GLUCOSE 0,5-2 ML
16077813|NCT02325583|Drug|Midazolam|INTRAVENOUS 0.1 MG/KG MIDAZOLAM
16077814|NCT02325570|Device|KLOX BioPhotonic OraLum Gel|Klox BioPhotonic OraLum Gel will be used with a LED curing lamp as an adjunct to conventional non-surgical periodontal treatment (SRP).
16077815|NCT02325570|Procedure|Scaling and Root Planing (SRP)|Scaling and Root Planing (SRP) is the conventional non-surgical treatment of chronic periodontitis.
16077816|NCT02325557|Drug|ADXS31-142|starting at 1x10^9 cfu IV
16077817|NCT02325557|Drug|ADXS31-142 + Pembrolizumab (MK-3475)|starting at dose from Part A + 200mg of Pembrolizumab
16078005|NCT02324088|Drug|Cyclophosphamide|
16078006|NCT02324088|Drug|Epirubicin|
16078124|NCT02323204|Other|So you've been in an accident|Educational materials
16077818|NCT02325544|Behavioral|Cognitive Behavioral Therapy|"12 sessions of CBT (over 4-5 months) +1 booster session. Guided by a therapy manual and patient handouts; will involve setting homework tasks. Although treatment is manualised, it allows treatment to be formulation-based i.e. tailored to the person.
~Standardised medical as described in other intervention."
16077819|NCT02325544|Behavioral|Standardized Medical Care|Delivered by neurologists/ psychiatrists - both will be involved in discussing diagnosis. It will Include an information sheet about dissociative seizures and direction to self-help websites, general information provision about management of DS and support, consideration of psychiatric comorbidities / associated drug treatment and general review but no CBT techniques.
16077820|NCT02325531|Other|Low support|"EHR-based tools, built by OCHIN, activated during Year 1 TOOLKIT, paper and electronic form, includes documents to help support ALL implementation, and
~BASIC WEBINAR, Annual, 1-hour, topics such as:
~Talking to Clinicians About ALL, Using The Monthly Feedback Report and Integrating the Toolkit into Workflows"
16077821|NCT02325531|Other|Medium support|"Same as provided to the low support arm, PLUS
~STAFF TRAINING (2-day meeting in Portland, Oregon, Led by Implementation Specialists (IS), How to use the toolkit and how to train others to use it, Content guided by previous research, baseline survey results, study team and the S-N advisory group
~ADAPTIVE WEBINARS, Quarterly 1-hr webinars, Content from basic webinars, tailored to topics requested by study clinics. Forum for group discussion and best practice sharing. Open any interested clinics in Arm 2 & 3."
16077822|NCT02325531|Other|High support|"Same as provided to the low and medium support arms, PLUS
~- PRACTICE FACILITATION: Site visits with support as needed, Staff presentations, Coaching on tools (how to present to clinic staff and how to use in the clinic workflow), Tailored problem-solving support to address identified barriers, Clinical questions fielded by RN practice facilitator and site clinician champion."
16077823|NCT02325518|Drug|Brinzolamide 1%/Timolol maleate 0.5% fixed combination ophthalmic suspension|
16077824|NCT02325518|Drug|Dorzolamide hydrochloride 1%/Timolol maleate 0.5% ophthalmic solution|
16077825|NCT02325518|Drug|Subject's habitual PGA monotherapy|
16077826|NCT02325492|Drug|Aramchol|
16077827|NCT02325492|Drug|Placebo|
16077828|NCT02325492|Device|Ultrasound|
16077829|NCT02325479|Drug|Enaoxaprin sodium|intrauterine administration after oocyte pickup as the main experimental intervention
16077830|NCT02325479|Drug|tissue culture media|intrauterine administration after oocyte pickup as placebo
16077831|NCT02325466|Drug|Aspirin|Aspirin 81mg
16077832|NCT02325466|Drug|Ticagrelor|ticagrelor 90 mg
16077833|NCT02325466|Drug|Aspirin Placebo|
16077834|NCT02325466|Drug|Ticagrelor Placebo|
16077835|NCT02325453|Procedure|Robotic Surgery|Surgical procedure performed with a robotic system.
16077836|NCT02325453|Procedure|Laparoscopic Surgery|Surgical procedure performed with laparoscopic techniques.
16077837|NCT02325453|Procedure|Open Surgery|Traditional approach for gastric cancer.
16077838|NCT02325440|Drug|Fingolimod|Fingolimod: 0.5 mg p.o. (o.i.d)
16077839|NCT02325440|Drug|Natalizumab|Natalizumab: 300 mg i.v. (once at baseline);
16077840|NCT02325427|Device|tDCS|tDCS could deliver either real or sham stimulation.
16077841|NCT02325414|Drug|Zoledronic acid|Intravenous infusion of zoledronic acid 5 mg.
16077842|NCT02325414|Drug|Placebo|Placebo (saline) infusion to match zoledronic acid
16077843|NCT02325401|Drug|Metformin|Escalating doses of 2000mg, 2550 mg and 3000mg. Starting 1 week prior to the initiation of chemoradiation and ending the final day of chemo or radiation.
16077844|NCT02325401|Drug|Cisplatin|Dosed at 100mg/m2 on days 1, 22, and 43
16077845|NCT02325401|Radiation|Radiation Therapy|70 Gy in 2 Gy once daily fractions of 35 fractions
16077846|NCT02325388|Device|ForeSite PT™ system|"XSENSOR Technology Corporation's ForeSite PT™ Patient Turn System (referred to as the ForeSite PT™ system) continuously monitors interface pressure and provides CPI that quantifies real-time interface pressure information. It also provides patient turn tracking to assist with management of the patient turn schedule by alerting healthcare providers and/or caregivers to the location of body areas that have experienced the greatest exposure, and when the next turn/repositioning is due as per pre-set alerts."
16077847|NCT02325375|Procedure|lumbar puncture for spinal fluid and blood sample|lumbar puncture for spinal fluid and blood sample
16077848|NCT02325362|Drug|Miglustat ; placebo|For this 2 x 2 (2 periods /2 treatments) crossover design each patient will receive Miglustat during the first period (2 weeks), following by a wash out period(14 days (up to 4 weeks)), then Placebo during the second period (2 weeks). 30 days follow-up will be carried out after end-of-treatment of the second period.
16077849|NCT02325362|Drug|Placebo ; Miglustat|For this 2 x 2 (2 periods /2 treatments) crossover design each patient will receive Placebo during the first period (2 weeks), following by wash out period (14 days (up to 4 weeks)), then Miglustat during the second period (2 weeks). 30 days follow-up will be carried out after end of treatment of the second period.
16077850|NCT02325349|Drug|radiopharmaceutical (Flotegatide (18F) or RGD (68Ga)|PET/CT after intravenous administration of 2-4MBq/kg of body weight of Flotegatide (18F) or RGD (68Ga) performed prior and after 2 cycles of chemotherapy including an agent with antiangiogenic effect (two examinations in each patient)
16077851|NCT02325336|Device|BCMA (bar-code-assisted medication administration)|"Implementation of ADIM system (Aide a la Distribution Informatisee des Medicaments) which consists of 2 machines with photographic reconnaissance and readers: one for preparation assistance that can be placed at the pharmacy or in the clinical service and one to assist the administration by the nurse in the clinical service.
~In case of discrepancy with the prescription, there is a visual alert. However, the alert can be override by the nurse if she/he gives a justification."
16077852|NCT02325310|Biological|Combined measles-mumps-rubella (MMR) vaccine - PRIORIX®|One dose of 0.5 mL vaccine will be administered (intra-muscularly or subcutaneous) in post-partum (before the exit of the maternity) during visit V0. A second dose will be administered at week 8(+/-15 days) during visit V1.
16077853|NCT02325297|Other|Letter of condolence|
16077854|NCT02325284|Device|Pressure Algometer Testing|
16077855|NCT02325271|Other|Frequent blood and urine sampling and blood pressure measurement|Blood and urine sampling for the determination of VEGF and biomarkers
16078007|NCT02324075|Behavioral|Behavior change|Non governmental organization delivers communication intervention with facilitating hardware, a waste bin and bucket
16077856|NCT02325258|Other|Telephone call|Aug-Dec 2012. Prospective study in patients who had blood cultures drawn and sent to the Microbiology Lab during the morning shift (9 am to 3 pm, Mon- Fri) to evaluate sepsis recognition. The investigators allocated 300 patients to 2 groups of 150 patients each, by opportunity sampling: patients whose clinical history number ended in odd numbers were assigned to group A (intervention) and those whose clinical history number ended in even numbers were assigned to group B (no intervention, control group). For patients in group A, the investigators attempted a telephone contact with the physician and/or nurse in charge and an interview, issuing recommendations regarding the convenience of further biochemical, microbiological or extra radiologic tests, and management and antimicrobial therapy.
16077857|NCT02325245|Drug|Metformin|Metformin tablet 500 mg three times a day for 16 weeks. If there is no significant outcome obtained between two arms in 16 weeks, metformin will continue until 24 weeks.
16077858|NCT02325245|Drug|Placebo|Placebo three times a day for 16 weeks. If there is no significant outcome obtained between two arms in 16 weeks, placebo will continue until 24 weeks.
16077859|NCT02325232|Device|Capsule endoscopy, double balloon enteroscopy sequential use|Small bowel capsule endoscopy followed by double-balloon enteroscopy with histological sampling in case of mucosal alterations
16077860|NCT02325219|Drug|CNTO 1959 50 mg|Participants will receive subcutaneous injection of CNTO 1959 50 mg.
16077861|NCT02325219|Drug|CTNO 1959 100 mg|Participants will receive subcutaneous injection of CNTO 1959 100 mg.
16077862|NCT02325219|Drug|Placebo 50 mg|Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 50 mg.
16077863|NCT02325219|Drug|Placebo 100 mg|Participants will receive subcutaneous injection of Placebo matched to CNTO 1959 100 mg.
16077864|NCT02325206|Drug|dapagliflozin|one administration in the morning
16077865|NCT02325206|Drug|Placebo|one administration in the morning
16077866|NCT02325193|Device|Minimed®640G system|Sensor augmented insulin therapy with and without use of Predictive low glucose management (PLGM)
16077867|NCT02325180|Drug|Dihydroartemisinin-Piperaquine|
16077868|NCT02325180|Drug|Artemether-lumefantrine|
16077869|NCT02325167|Behavioral|EBT|participants assigned to the intervention arm will receive 2 manualised therapy sessions with focus on mindfulness and activating resources delivered by trained therapists at the Clinic of Palliative Care
16077870|NCT02325167|Behavioral|treatment-as-usual|participants assigned to the treatment-as-usual arm will receive 2 supportive sessions delivered by trained therapists at the Clinic of Palliative Care
16077871|NCT02325154|Device|Cerebral Oximeter|Use of cerebral oximeter to monitor cerebral oxygenation for occurence of desaturation events.
16077872|NCT02325141|Procedure|laparoscopic sleeve gastrectomy|creation of a gastric tube of 100cc using a stapler.
16077873|NCT02325128|Behavioral|Sleep-enhancement of extinction memory|Recent reports show that sleep promotes memory consolidation. The investigators' preliminary findings suggest sleep may enhance the therapeutic extinction memories acquired during exposure therapy. For sleep-enhancement of extinction memory, the current intervention uses post-exposure naps as a means to provide sleep in close temporal proximity to the encoding of memory for the extinction social exposure fears in individuals with severe social anxiety symptoms.
16077874|NCT02325102|Other|No intervention|As this is an observational study, no intervention was conducted.
16077875|NCT02325089|Device|Mandibular advancement device|Use of a mandibular advancement device every night during one year. Device will be titrated to reduce or - if possible - eliminate snoring and sleep apnea.
16077876|NCT02325089|Device|Placebo|Placebo oral appliance will be identical to the mandibular advancement device without, however, the attachemnt to allow mandibular advancement. It will be used every night during one year.
16077877|NCT02325076|Device|Spirodoc|A device to detect the physical condition of the lungs
16077878|NCT02325063|Drug|PRP-L Injection|Patients will be treated with an injection of leukocyte and platelet rich plasma.
16077879|NCT02325063|Drug|Botox injection|Patients will be treated with an injection of Type A Botulinum toxin.
16077880|NCT02325063|Drug|Corticoid injection|Patients will be treated with an injection of Corticoids.
16077881|NCT02325050|Biological|MVA-BN-Filo|One 0.5 milliliter (ml) intramuscular (IM) injection of 1*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
16077882|NCT02325050|Biological|Ad26. ZEBOV|One 0.5 mL IM injection of 5*10^10 viral particles (vp).
16077883|NCT02325050|Biological|MVA-BN-Filo|One 0.5 milliliter (ml) intramuscular (IM) injection of 4.4*10^8, (50%Tissue Culture Infectious Dose [TCID50]).
16077884|NCT02325050|Biological|Ad26. ZEBOV|One 0.5 mL IM injection of 1*10^11 viral particles (vp).
16077885|NCT02325050|Other|Placebo|One 0.5 mL IM injection of 0.9% saline.
16077886|NCT02325037|Drug|GLPG1837 single ascending doses|Single dose, oral suspension
16077887|NCT02325037|Drug|Placebo single dose|Single dose, oral suspension matching placebo
16077888|NCT02325037|Drug|GLPG1837 multiple ascending doses|Multiple doses, daily for 14 days, oral suspension
16077889|NCT02325037|Drug|Placebo multiple doses|Multiple doses, daily for 14 days, oral suspension, matching placebo
16077890|NCT02325024|Drug|Sativex|Each 100 uL actuation (spray) of Sativex contains 27 mg/mL THC and 25 mg/mL CBD plus peppermint flavouring. The study dosage of 10.8 mg THC and 10 mg CBD is delivered as four sprays to the oral mucosa.
16077891|NCT02325011|Drug|Sativex® (Treatment A)|Each 100 uL actuation (spray) of Sativex contains 27 mg/mL THC and 25 mg/mL CBD plus peppermint flavouring. The study dosage of 10.8 mg THC and 10 mg CBD is delivered as four sprays to the oral mucosa.
16077892|NCT02325011|Drug|Sativex® and fluconazole concomitantly (Treatment B)|"Each 100 uL actuation (spray) of Sativex contains 27 mg/mL THC and 25 mg/mL CBD plus peppermint flavouring. The study dosage of 10.8 mg THC and 10 mg CBD is delivered as four sprays to the oral mucosa.
~Fluconazole 200 mg twice daily (BID) for two days, will be administered at the following time points relative to the Day 1 Sativex dose: 1 hour pre-dose, and approximately 11, 24, and 36 hours post-dose."
16077893|NCT02324998|Drug|Olaparib|PARP Inhibitor
16077894|NCT02324998|Drug|Degarelix|Gonadotrophin releasing hormone blocker
16077895|NCT02324985|Drug|S-Ibuprofen Topical Gel 5%|S-Ibuprofen Topical Gel 5% applied every 6 hours
16077896|NCT02324985|Drug|Vehicle Topical Gel|Vehicle Topical Gel applied every 6 hours
16077897|NCT02324972|Drug|AQX-1125|Synthetic SHIP1 activator
16077898|NCT02324972|Drug|Placebo|
16077899|NCT02324959|Device|RehaCom|The computer-based neurorehabilitation program is intended for patients with acquired cognitive deficits after brain damage, e.g. after stroke. The RehaCom software has five different therapeutic groups aimed at restoration of attention, memory, executive functions, and visual field, respectively. Each group has one to four different modules to choose from for each therapy session. Only attention will be trained in this study.
16077900|NCT02324959|Device|Acupuncture|"The affected meridian group is treated by needling on Baihui (GV20|DU20) and Shenting (GV24|DU24) - both acupoints of the Governor Vessel. Baihui is 5 cun (1cun=3.33 cm) superior to the anterior hairline on the anterior median line (midpoint of the connecting line between the auricular apices)."
16077901|NCT02324946|Other|Mass Screening|Preoperative screening with STOP-BANG and DES-OSA scores and postoperative comparison with difficult intubation / ventilation scores.
16077902|NCT02324933|Drug|Fentanyl|Fentanyl Patient Controlled Analgesia for post-operative pain management
16077903|NCT02324920|Device|DDD-CLS|
16077904|NCT02324920|Device|ODO|
16077905|NCT02324907|Device|Procedure/Surgery|Tibiotalocalcaneal (TTC) arthrodesis with a novel dynamic compression intramedullary nail. The assignment of the device is at the discretion of the standard of care provider, not the study investigator.
16077906|NCT02324894|Procedure|MRI screening|Diagnostic screening. The normal eligible screening population will first undergo a mammography, then an echography screening followed by a fast MRI screening.
16077907|NCT02324881|Behavioral|Telephone-Based Intervention|Use PSMA
16077908|NCT02324881|Other|Questionnaire Administration|Ancillary studies
16077909|NCT02324868|Device|Shower patch IV catheter protection|Shower patch will be available for the patient for bathing activities
16077910|NCT02324868|Device|Conventional IV catheter protection|No Shower patch will be provided during study period
16077911|NCT02324855|Other|Chest physiotherapy plus usual care|Subjects will perform daily chest physiotherapy during at least 30 minutes. Patients will perform a slow expiratory airway clearance technique combined with positive expiratory pressure device (Acapella device, Murray et al.) Each patient will receive 12 supervised professional sessions (once a month).
16077912|NCT02324842|Drug|Canagliflozin|Canagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus (1)
16077913|NCT02324842|Drug|Liraglutide|Liraglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
16077914|NCT02324816|Device|The Zeltiq CoolSculpting System|The CoolSculpting System delivers non-invasive cooling for the reduction of subcutaneous fat.
16077915|NCT02324803|Drug|pazopanib|continuous treatment of 800 mg pazopanib once daily until disease progression
16077916|NCT02324790|Device|iNAP® Sleep Therapy System|The iNAP® Sleep Therapy System provides pressure gradient within the oral cavity to pull the tongue toward upper palate and the soft palate forward, which aims to maintain better upper airway patency near the pharynx to prevent sleep-disordered breathing.
16077917|NCT02324777|Drug|Cannabis|Cannabis sativa L. subsp. indica, variety indica blends of flowering heads that have been air-dried, milled, destemmed and fine ground, stored in glass vials with aluminum caps in 100 mg dose size.
16077918|NCT02324777|Device|Volcano® Medic Vapourizer|"Volcano® Medic vapourizer is licensed for medical administration of cannabis in Canada March 2010 (Licence No. 82405).
~The contents of a vial of drug product formulation will be transferred to the Volcano® Medic's filling chamber (sample-holder) equipped top and bottom with fine wire mesh to retain the finely ground material. The filling chamber will be placed atop the main body of the unit and then have a, 12.5 L, heat-resistant Medic Valve balloon affixed. Active components are vapourized at 190 °C. The ensuing vapour is captured in the balloon and inhaled by the study subject using a standardized inhalation technique."
16077919|NCT02324764|Device|Glidesheath Slender|testing the efficacy and safety of the new transradial sheath in comparison to the standard 6 french sheath.
16077920|NCT02324764|Device|standard 6- French radial sheath|
16077921|NCT02324751|Biological|Vi-TCV|Each 0.5mL vaccine dose contains 25μg of purified Vi capsular polysaccharide (S. Typhi Ty2 strain) conjugated to non-toxic tetanus toxoid. The vaccine will be administered 28 days prior to typhoid challenge
16077922|NCT02324751|Biological|Vi-PS Vaccine|Each 0.5 mL vaccine dose contains 25 μg of purified Vi capsular polysaccharide (S. Typhi Ty2 strain). The vaccine will be administered 28 days prior to typhoid challenge
16077923|NCT02324751|Biological|Control (Men ACWY)|Each vaccine dose contains N. meningitidis oligosaccharides (10μg MenA oligosaccharide, 5μg of each of MenC, Men Y and MenW-135 oligosaccharides) conjugated to 32.7 μg to 64.1μg Diphtheria CRM197 protein with residual formaldehyde dose less than 0.30μg. The vaccine will be administered 28 days prior to typhoid challenge
16077924|NCT02324738|Drug|Mefloquine and Dihydroartemisinin-piperaquine|2 tablets of mefloquine and 3 tablets of dihydroartemisinin-piperaquine single dose
16077925|NCT02324738|Other|Wash-out period|
16077926|NCT02324738|Drug|Mefloquine|2 tablets of Mefloquine single dose
16077927|NCT02324725|Drug|Naltrexone|Up to three monthly injections of 380 mg of naltrexone suspended in dissolvable polymer microspheres and administered intramuscularly
16077928|NCT02324712|Device|Acupuncture|Acupuncture using standard stainless steel acupuncture needles inserted into intramuscular tissue for 20 minutes
16077929|NCT02324712|Device|Sham Acupuncture|Acupuncture using non-penetrating Park Sham Needles for 20 minutes
16077930|NCT02324699|Drug|Prednisone|
16077931|NCT02324699|Drug|Placebo|
16077932|NCT02324699|Drug|Vedolizumab|300mg IV over 30 minutes. Both arms will receive vedolizumab at weeks 0, 2, and 6.
16077933|NCT02324686|Drug|vitamin K1|Vitamin K1 400 mcg orally three times a week on dialysis days for four months
16077934|NCT02324673|Drug|Cannabidiol Oral Solution|An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
16077935|NCT02324660|Other|screening test|screening test with peak expiratory flow and respiratory health screening questionnaire to discriminate patients at risk for COPD
16078008|NCT02324062|Other|Questionnaires|These participants will be asked to complete questionnaires for the duration of the study (up to 60 months after enrollment) at 3 months, 6 months, 12 months, 24 months, 36 months, 48 months, and 60 months.
16078203|NCT02322567|Other|medical records|review of medical records
16077936|NCT02324634|Device|NeuroTrac Rehab dual channel device|ES intervention twice a day, 5 days a week, for 3 months applied to the wrist extensors and wrist flexors. The therapist will identify the motor points for the forearm flexors and the extensors, and will place an electrode on these motor points using sticky pads. They will then connect the electrodes to the respective channels in the electrical stimulator. The ES will be set to deliver a 450μs pulse at a frequency of 40-60Hz (as per patient convenience). The intensity of the current will be increased to produce an alternating contraction of the flexors and extensors using a flex-hold-extend-hold pattern. A single stimulation and hold cycle will last 20 seconds and this will be cyclically repeated for 30 minutes after which the device can be removed.
16077937|NCT02324621|Drug|Oral ONC201|Given PO
16077938|NCT02324621|Other|pharmacological study|Correlative studies
16077939|NCT02324621|Other|laboratory biomarker analysis|Correlative studies
16077940|NCT02324608|Biological|cetuximab|Given IV
16077941|NCT02324608|Other|laboratory biomarker analysis|Correlative studies
16077942|NCT02324595|Procedure|Laparoscopic interval debulking surgery|"Diagnostic laparoscopy with a careful exploration of peritoneal cavity: if available a 5 mm flexible tip videolaparoscope will be used to explore all peritoneal recesses.For eligible patients,will be placed 3 5mm trocar in standard position for pelvic surgery:cytoreduction will consist in total/radical hysterectomy,bilateral salpingo-oophorectomy,radical omentectomy.If needed pelvic/upper peritonectomy will be performed:in these cases additional trocar can be placed in right or left subcostal spaces. All surgical procedure requested will have be carried out by laparoscopy/robotic or by laparotomy,in case of increased surgical risk or technical impossibility:the case will be registered as laparotomic conversion.At the end of surgical procedures residual tumor will be registered"
16077943|NCT02324582|Drug|Intravenous MK-3475/ Intravesical BCG|6 cycles (each cycle is 21 days) of pembrolizumab will be given over 9 weeks in combination with BCG. BCG treatment will begin on Day 1 of cycle 3 of pembrolizumab.
16077944|NCT02324569|Drug|SYR-472|SYR-472 tablets
16077945|NCT02324569|Drug|Placebo|Placebo tablets
16077946|NCT02324543|Drug|Gemcitabine|IV on days 4 and 11 of a 21 day cycle
16077947|NCT02324543|Drug|Taxotere|IV on days 4 and 11 of a 21 day cycle
16077948|NCT02324543|Drug|Xeloda|Twice a day orally on days 1 through 14 of a 21 day cycle
16077949|NCT02324543|Drug|Cisplatin|IV on days 4 and 11 of a 21 day cycle
16077950|NCT02324543|Drug|Irinotecan|IV on days 4 and 11 of a 21 day cycle
16077951|NCT02324530|Device|Continuous positive airway pressure (CPAP)|CT simulation with and without CPAP
16077952|NCT02324504|Device|C3 Wave ECG-based PICC Tip Confirmation System|The C3 Wave PICC tip detection system will be used to identify catheter tip location during the procedural placement of the catheter. This system includes an ECG monitor that will be connected to the guidewire used for catheter placement. The changes in the ECG tracing will guide correct catheter placement.
16077953|NCT02324491|Drug|ZGN-440 for Injectable Suspension|Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 52 weeks.
16077954|NCT02324491|Drug|ZGN-440 Placebo for Injectable Suspension|Subjects will receive placebo twice weekly subcutaneous injections for up to 52 weeks.
16077955|NCT02324478|Procedure|autonomic nervous system analysis|electrocardiographic and pulse-photoplethysmographic waves of patients under general anesthesia for laparoscopic cholecystectomy will be recorded on a laptop pc for offline analysis of autonomic nervous system modulation a three main time point: 1) at baseline, before general anesthesia induction, 2) five min after tracheal tube placement, 3) five min after pneumoperitoneum insufflation.
16077956|NCT02324465|Device|King Vision Video Laryngoscope|Intubation via King Vision Video Laryngoscope
16077957|NCT02324465|Device|Glidescope Video Laryngoscope|Intubation via Glidescope Video Laryngoscope
16077958|NCT02324452|Drug|Fluoropyrimidine (capecitabine or 5-fluorouracil)|Patient that are a heterozygous carrier of a DPYD variant will receive a reduced dosage of capecitabine or 5-fluorouracil (25-50% reduction, depending on which SNP is identified). The dose will be titrated in subsequent cycles, to achieve maximal safe exposure. Patients that are wild type (not carrying any of the for DPYD variants) will receive a normal (full) dose.
16077959|NCT02324439|Drug|Omega Nutrition cold-milled flaxseeds|Patients who are currently in clinical remission will receive a daily 20g dose of cold milled flaxseed as a dietary supplement to determine if this intervention prolongs clinical remission.
16077960|NCT02324426|Drug|Reduced Glutathione|200 mg GSH delivered in 1 cc sterile saline using a syringe with a Mucosal Atomization Device (MAD) tip.
16077961|NCT02324413|Drug|Clonidine|Comparison between placebo and 2 different concentrations of clonidine
16077962|NCT02324413|Drug|Placebo|
16077963|NCT02324400|Device|RenaSense Stimulation|RenaSense Catheter, Electrical Stimulation of the Urinary Bladder Wall
16077964|NCT02324400|Device|RenaSense Sham Control|RenaSense Catheter,no delivery of stimulation
16077965|NCT02324387|Procedure|Molecular Breast Imaging (MBI)|Participants undergo 3 MBI scans with injections of injection of Tc99m sestamibi before each scan. First scan is 7 days before scheduled neoadjuvant chemotherapy (NAC) treatment, after 2 cycles of chemotherapy, and after completion of chemotherapy treatment.
16077966|NCT02324387|Drug|Tc99m sestamibi|8 mCi of 99mTc sestamibi by vein before each molecular breast imaging (MBI).
16077967|NCT02324374|Device|Endocystoscopy During Colonoscopy|Colonoscopies will be performed as per routine practice. When a colorectal lesion is found that would normally require biopsy or polypectomy; the lesion will be evaluated by chromoendoscopy with the application of 10 ml 1% methylene blue followed by the inspection with the endocytoscope at both magnifications (450X and 1100X). The endocytoscopic images of the abnormal area will be recorded prior to biopsy or removal of the suspicious tissue. For each lesion, a matching endocytoscopy image from normal adjacent tissue will also be obtained, at least 5cm away from the suspect site, but within the same segment of intestine (e.g. ascending colon). No biopsy will be obtained from normal tissue, and this will be assumed to be normal. Following image acquisition, the lesion will be biopsied or removed as per standard clinical care.
16078009|NCT02324062|Other|Blood Draw and Baseline Questionnaire|Participants will have their blood drawn for the study and complete a baseline questionnaire about their current cancer screening practices and concern regarding cancer.
16078010|NCT02324049|Drug|SBC-103|
16078011|NCT02324036|Device|EMPATHy Toolkit|Software-based toolkit to help patients identify and prioritize barriers to medication adherence; community health worker provides participation training to patient
16077968|NCT02324374|Device|Endocytoscope|The endocytoscopes, prototype I and prototype II will be used during the study along with the standard colonoscopes. The endocytoscope is a soft catheter type endoscope, with an outside diameter of 3.4 mm at the distal end and 3.2 at the shaft, and total length of 380 cm (working length of 250 cm) which uses a lens system for magnification. The Prototype 1 endocytoscope (low resolution type) has a magnification capability of x 450, depth of field of 50 um, field of view of 300X 300 um with a spatial resolution of 1.7 um. The Prototype 2 (high resolution) has a magnification capability of x1125, depth of field of 5um, field of view of 120X 120 um, and a spatial resolution of 4.2 um, The ECS system can be passed through the working channel of a standard colonoscope.
16077969|NCT02324361|Other|Physical Activity|The Fitbit Zip is a wireless physical activity monitor that will be worn by the index child during waking hours, and will be used to assess daily active time for the duration of the study.
16077970|NCT02324361|Behavioral|Evidence-based information on healthy family routines|Educational dimensions include nutrition, frequency of family meals, child's screen time, bedtime routines, physical activity, and sleep hours.
16077971|NCT02324348|Procedure|Deferred coronary stenting|Abciximab (0.25㎎/㎏) intracoronary injection will be performed to all possible patients after guidewire has passed culprit lesion. Additional manual thrombus aspiration or balloon angioplasty can be performed by operator to achieve TIMI Ⅲ flow. When TIMI Ⅲ flow is achieved after these procedures, patient will be randomized to immediate stenting or deferred stenting group. In deferred stenting group, second stage procedure (stent implantation) will be done at 5 to 7 days after TIMI Ⅲ flow has achieved.
16077972|NCT02324348|Procedure|Immediate coronary stenting|Abciximab (0.25㎎/㎏) intracoronary injection will be performed to all possible patients after guidewire has passed culprit lesion. Additional manual thrombus aspiration or balloon angioplasty can be performed by operator to achieve TIMI Ⅲ flow. When TIMI Ⅲ flow is achieved after these procedures, patient will be randomized to immediate stenting or deferred stenting group. In immediate stenting group, stenting will be done immediate after achieving TIMI III flow during initial procedure.
16077973|NCT02324335|Drug|Brilacidin|Oral Rinse used 3 times daily for 7 weeks
16077974|NCT02324335|Other|Placebo|
16077975|NCT02324322|Device|Exoskeleton Training|Exoskeleton Training (100 sessions - 1 hour, 4 - 5 sessions per week for 20 weeks) to enhance functional ambulation for persons with a spinal cord injury. To examine the effectiveness of exoskeleton assisted overground walking to induce positive changes in muscle volume and structure of the lower limbs for non-ambulatory persons with SCI.
16077976|NCT02324322|Other|Muscle Biopsies|"Needle Biopsies for Quadricep Muscles will be performed to define changes in BMD and Bone structure with intensive exoskeleton assisted walking. This procedure includes having a trained physician make a small skin incision, after numbing the area over the muscle, and then removing a tiny sliver of muscle to study under the microscope. Three separate biopsies for one incision will be obtained. The biopsies will be performed at baseline, 7 days, and after the intervention.
~To define changes in biochemical markers of bone metabolism with intensive exoskeleton-assisted walking."
16077977|NCT02324322|Other|MRI|MRI's will provide accurate assessments of muscle CSA of each lower limb (from above the origin of the iliopsoas to the insertion of the achilles tendon) to determine individual's muscle thigh and shank volume.
16077978|NCT02324309|Drug|BIOD-531|
16077979|NCT02324309|Drug|Humalog Mix 75/25|
16077980|NCT02324309|Drug|Humulin R U-500|
16077981|NCT02324309|Drug|BIOD-531|
16077982|NCT02324296|Drug|ifosfamide|PEI regimen may be a possible therapeutic option, with high activity and an acceptable toxicity profile.
16077983|NCT02324283|Drug|desflurane|"Desflurane group: this group of patients receives desflurane as the main anesthetic agent during one-lung anesthesia.
~Propofol group: this group of patients receives propofol as the main anesthetic agnet during on-lung anesthesia."
16077984|NCT02324283|Drug|propofol|Propofol group:this group of patients receives propofol as the main anesthetic agent during one-lung anesthesia.
16077985|NCT02324270|Drug|Diclofenac epolamine|Diclofenac epolamine in a topical patch formulation; applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain
16077986|NCT02324270|Other|Placebo|Topical patch not containing diclofenac epolamine applied to the area of sprained ankle; to treat pain associated with a mild ankle sprain
16077987|NCT02324257|Drug|RO6958688|RO6958688 is given as an intravenous (IV) infusion as a single administration in Part I, and QW, Q3W, or as a combined QW/Q3W step up dosing regimen (cycle = 7 days in the QW regimen and cycle = 21 days in the Q3W regimen) in Part II of the study.
16077988|NCT02324257|Drug|Obinutuzumab|Obinutuzumab is given as an IV infusion at a dose level of 2000 mg on Day -13 or 1000 mg on Days -13 and -12 prior to the treatment start with RO6958688 on Cycle 1 Day 1.
16077989|NCT02324257|Drug|Tocilizumab|Tocilizumab will be administered as an IV infusion as necessary to treat adverse events.
16077990|NCT02324231|Other|39.0°C temperature limit defining fever|Diagnosis of FN, correspondingly hospitalization and start of empirical intravenous broad-spectrum antimicrobial therapy. Further treatment according to treating physician.
16077991|NCT02324231|Other|38.5°C temperature limit defining fever|Diagnosis of FN, correspondingly hospitalization and start of empirical intravenous broad-spectrum antimicrobial therapy. Further treatment according to treating physician.
16077992|NCT02324218|Other|Data collection|Data extraction from CPRD database of UK.
16077993|NCT02324205|Device|DBT and FFDM|Subjects underwent breast imaging using each device: DBT and FFDM.
16077994|NCT02324192|Other|Ultrasonography|imaging findings
16077995|NCT02324166|Drug|Cefazolin|cephalosporin antibiotic
16077996|NCT02324166|Drug|Lidocaine|local anesthetic
16077997|NCT02324153|Drug|Ramelteon|1 pre-operative and 2 nightly postoperative doses of Ramelteon/placebo will be administered
16077998|NCT02324153|Drug|Microcrystalline Cellulose|Placebo Comparator
16077999|NCT02324153|Drug|Riboflavin 100 mg|Riboflavin will be added to both placebo and active intervention capsules in order to track adherence to dose while taken as an outpatient (i.e. only the first preoperative dose)
16078000|NCT02324140|Other|Whole blood analysis|In all fours groups of patients we investigate inflammatory and antiinflammatory response to the surgical and interventional treatment by analyzing changes in the concentration of interleukins, C-reactive protein, soluble CD62L and HLA-DR.
16078001|NCT02324127|Device|hsp90|Detect plasma Hsp90α concentration of lung cancer patients
16078012|NCT02324036|Behavioral|Coached Care|Community health worker provides participation training to patient
16078013|NCT02324023|Device|Endoscopic ultrasound|All patients will be evaluated by EUS and CE-EUS, using radial EUS instruments. The EUS scope will be inserted under direct vision, passed by the tumour and examination should begin during withdrawal at 7.5 MHz. The tumour will be characterized describing its echogenicity, echo structure, size, extent into the bowel wall and surrounding structures, and it will be staged using the modification of the TNM classification, based on a five-layer intestinal wall model. The presence/absence of power Doppler signals will be noted. For CE-EUS parameters for objective measurement of tumour perfusion will include maximum intensity of enhancement, mean transit time, time to peak (wash-in time), wash-in slope, area under the curve, representing indirectly blood flow or blood volume in CRC patients.
16078014|NCT02324010|Drug|Sitagliptin|100mg mane for 2 days
16078015|NCT02324010|Drug|Placebo|Inactive drug (Placebo)
16078016|NCT02323984|Other|miRNA Testing, Microemboli Monitoring, Delirium Assessment|Delirium assessment questionnaire and blood testing for miRNA will be done for all patients postoperatively, as well as BIS monitoring during surgery. The three arms of the study indicate the allocation of each patient based on their delirium presentation (hypoactive, hyperactive, or none).
16078017|NCT02323971|Drug|Ticagrelor|
16078018|NCT02323958|Other|acupoint stimulation|stimulation is given at acupoints
16078019|NCT02323958|Other|non-acupoint stimulation|stimulation is given at acupoints
16078020|NCT02323958|Other|electrode attached|electrodes are attached to skin
16078021|NCT02323958|Device|electrical stimulation|electrical stimulation is given through electrodes attached to th skin
16078022|NCT02323945|Other|AIH|Participants will breathe intermittent low oxygen via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of fraction of inspired oxygen (FiO2) = 0.10±0.02 (hypoxia). Participants will receive treatment on 5 consecutive days.
16078023|NCT02323945|Other|Walk|30 minutes of walking practice consisting of 5 repetitions of 6-minute walks
16078024|NCT02323945|Other|Strength|30 minutes of isometric ankle plantar flexion torque practice broken into 3 sets of 10 repetitions
16078025|NCT02323932|Behavioral|Perception of correct intonation identification|The amount of change in the fundamental frequency that was required in order to identify a question
16078026|NCT02323919|Behavioral|SystemCHANGE|consists of a series of five small-group (six to eight people) education sessions provided in three 1.5 -hour sessions once a week during the last three weeks of the CRP and in two sessions held at one and two months following completion of their CRP. An experienced cardiac nurse or exercise physiologist trained in the intervention protocol taught each of the sessions. In a series of structured activities, participants were taught to use behavior change strategies consistent with the respective intervention models. A series of three monthly booster calls were made during months four, five and six following the last intervention class and individuals were coached in the use of strategies consistent with the respective interventions.
16078027|NCT02323919|Behavioral|CHANGE+|consists of a series of five small-group (six to eight people) education sessions provided in three 1.5 -hour sessions once a week during the last three weeks of the CRP and in two sessions held at one and two months following completion of their CRP. An experienced cardiac nurse or exercise physiologist trained in the intervention protocol taught each of the sessions. In a series of structured activities, participants were taught to use behavior change strategies consistent with the respective intervention models. A series of three monthly booster calls were made during months four, five and six following the last intervention class and individuals were coached in the use of strategies consistent with the respective interventions.
16078028|NCT02323919|Behavioral|Usual Care|Participants will receive only the routine care provided to CRP patients. This care consists of assessment of exercise capacity, graduated exercise training (consisting of exercising three times a week at the cardiac rehabilitation center on treadmill or cycle, counseling about safe exercise {warm-up procedures, pulse taking, attending to body cues for exertion levels} and advisement to exercise on days between CRP sessions). At the end of the CRP, individuals are given an exercise prescription that includes their target heart rate and they are counseled to exercise at least 5 times a week for 30 minutes. This information is provided by the CRP personnel, usually in the form of individual informal conversations during exercise at the CRP.
16078029|NCT02323906|Drug|CC-122|Investigational new drug
16078030|NCT02323906|Drug|Sorafenib|Kinase inhibitor
16078031|NCT02323893|Drug|[18F]F-AraG|
16078032|NCT02323880|Other|Pharmacological Study|Correlative studies
16078033|NCT02323880|Drug|Selinexor|Given PO
16078034|NCT02323867|Device|Alpha Beta T cell depletion|
16078035|NCT02323854|Device|Ablation|Percutaneous antenna will be placed into the target tumor under CT image guidance. Target tumor will be ablated and the antenna will be removed.
16078036|NCT02323854|Procedure|Surgical Resection|The planned surgical resection of the lung tumor will be conducted as scheduled post ablation procedure.
16078037|NCT02323841|Procedure|conservative treatment|we performed pelvic lymphadenectomy before neoadjuvant chemotherapy and conization as conservative treatments
16078038|NCT02323828|Dietary Supplement|High RS cookies|High RS cookies ingestion in healthy young adults
16078039|NCT02323828|Dietary Supplement|Placebo|Placebo cookies ingestion in healthy young adults
16078040|NCT02323815|Dietary Supplement|Small-Quantity Lipid-based nutrient supplement|A monthly dose of SQ-LNS (31 sachets of 20g) will be distributed to mothers attending counselling sessions
16078041|NCT02323815|Behavioral|Child's health and nutrition topics|Monthly group counselling meetings organized at village level. Caregivers of participating children are invited to attend monthly counselling meetings that treat topics on child nutrition, health, hygiene and good sanitary practices. During these visits children are also screened for acute malnutrition measuring arm circumference.
16078042|NCT02323802|Behavioral|educational group intervention|
16078043|NCT02323802|Behavioral|prescriptive diet|
16078044|NCT02323789|Drug|Mesenchymal stromal cells|TC-MSC: a cell product containing mesenchymal stromal cells. Mesenchymal stromal cells are adherent non-haematopoietic multipotent cells that are expanded from bone marrow from healthy donors, using platelet lysate as source of growth factor.
16078045|NCT02323776|Other|Trimodality protocol|neoadjuvant chemoradiotherapy followed by surgery
16078122|NCT02323217|Drug|Isocarboxazid|Isocarboxazid block of [11C]BU99008
16078046|NCT02323763|Other|fMRI Scanning|Imaging will be performed on a 3T Siemens Trio scanner. Each MRI scanning session will last no more than 90 minutes. fMRI will be used to determine brain activation and differences in intertemporal discounting.
16078047|NCT02323737|Drug|Irinotecan and cisplatin|
16078048|NCT02323737|Drug|Etoposide and cisplatin|
16078049|NCT02323724|Genetic|BRAF V600E mutation by pyrosequencing technique|
16078050|NCT02323711|Device|2-octyl cyanoacrylate|If the subject is allocated to the experimental group, they would receive 2-octyl cyanoacrylate in place of a primary dressing consisting of their non-adherent composite dressing (Tefla) and a secondary dressing of Army Battle Dressing (ABD).
16078051|NCT02323698|Drug|Caffeine|Subjects will ingest capsules containing caffeine (up to 6mg/kg). Experiments will begin 30min after consumption to approximately coincide with peak plasma concentrations.Throughout the 30min wait time and experimentation, blood pressure and heart rate will be monitored.
16078052|NCT02323698|Other|AIH|Participants will breathe intermittent low oxygen via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of FIO2 (fraction of inspired oxygen) = 0.10±0.02 (hypoxia). Throughout experimentation, blood pressure and heart rate will be monitored.
16078053|NCT02323698|Other|Placebo|This is a placebo counterpart to the caffeine drug. Subjects will ingest capsules containing dextrose. Experiments will begin 30min after consumption to mimic the caffeine drug protocol. Throughout experimentation, blood oxygenation, blood pressure and heart rate will be monitored.
16078054|NCT02323698|Other|SHAM|This is a placebo counterpart to breathing intermittent low oxygen. Participants will breathe intermittent room air via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of FIO2 (fraction of inspired oxygen) = 0.21±0.02 (normoxia). Throughout experimentation, blood pressure and heart rate will be monitored.
16078055|NCT02323685|Biological|SANGUINATE™|Single infusion of SANGUINATE (pegylated carboxyhemogloblin)
16078056|NCT02323659|Drug|Methotrexate|Methotrexate 20mg per dose, administered orally, once every week
16078057|NCT02323659|Drug|Interferon Alfa-2b|Interferon Alfa-2b 3 million international units (MIU), administered 3 times per week
16078058|NCT02323646|Drug|Placebo|Matching placebo, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
16078059|NCT02323646|Drug|Telapristone Acetate|Telapristone acetate, vaginally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
16078060|NCT02323633|Device|Braingear Brainbuds Pulsed Current stimulation device|Transcranial Pulsed Current stimulation (tPCS) at random noise oscillating frequencies for a duration of 20 minutues
16078061|NCT02323633|Device|Sham|No transcranial Pulsed Current Stimulation (tPCS)
16078062|NCT02323620|Procedure|Intracoronary infusion of BM-MC|Bone marrow-derived progenitor cells are obtained from 60ml bone marrow aspirated from the iliac crest. Intracoronary infusion of the autologous cells is performed via conventional percutaneous intracoronary intervention techniques using an over-the-wire balloon technique.
16078063|NCT02323607|Drug|Pacritinib|Given PO
16078064|NCT02323607|Drug|Cytarabine|Given IV
16078065|NCT02323607|Drug|Daunorubicin Hydrochloride|Given IV
16078066|NCT02323607|Drug|Decitabine|Given IV
16078067|NCT02323607|Other|Laboratory Biomarker Analysis|Correlative studies
16078068|NCT02323607|Other|Pharmacological Study|Correlative studies
16078069|NCT02323594|Drug|Daclatasvir|Treatment A= single oral dose of Daclatasvir (DCV) tablet and Treatment B= single oral dose of DCV pediatric chewable tablet
16078070|NCT02323594|Drug|Daclatasvir|Treatment C= single oral dose of Daclatasvir (DCV) pediatric chewable tablet and Treatment D= single oral dose of DCV pediatric chewable tablet
16078071|NCT02323594|Drug|Asunaprevir|Treatment E= single oral dose of Asunaprevir (ASV) tablet and Treatment F= single oral dose of ASV pediatric chewable tablet and Treatment G= single oral dose of of ASV pediatric chewable tablet
16078072|NCT02323594|Drug|Daclatasvir|Treatment H= single oral dose of Daclatasvir (DCV) tablet and Treatment I= single oral dose of DCV tablets
16078073|NCT02323581|Device|Endovascular treatment of Thoracoabdominal Aortic Aneurysm|"A TAAA is an abnormal enlargement (ballooning out) of the main artery (the aorta) and involves all or part of the aorta in your chest as well as all or part of the aorta in the abdomen. It also involves the part of the aorta where the arteries that bring blood to the liver, stomach and intestines and kidneys are attached.
~This investigational procedure that is being studied uses stent-grafts (cylindrical fabric tubes (grafts), with metal springs (stents) attached). The stent-grafts are placed inside the aneurysmal (weakened) area of the aorta to re-line it. These customized stent-grafts have special branches attached to them or openings (called fenestrations) that are used to keep blood flowing to the arteries that supply the liver, stomach, intestines and kidneys. The investigational stent graft will be designed and custom-made specifically for your aneurysm."
16078074|NCT02323581|Device|Endovascular treatment of Aortic Arch Aneurysms|"An aortic arch aneurysm is an abnormal enlargement (ballooning out) of the main artery (the aorta). The ascending aorta and aortic arch is the first part of the vessel as it exits the heart and makes a turn around the area of the collar bone. This part of the aorta gives branches that supply the head, brain and arms.
~The arch branch endovascular graft includes the main aortic arch portion and one to three cuffs (side branches) that allow the graft to be located in the aortic arch. The number of cuffs is decided based on the anatomy of your aneurysm. The arteries in the aortic arch are the innominate artery (Zone 0), left common carotid artery (Zone 1) and the left subclavian artery (Zone 2). These arteries supply the right arm and right side of the brain, the left side of the brain and the left arm, respectively."
16078075|NCT02323568|Other|Gynecological consultation|
16078076|NCT02323555|Other|Paramedic telephone consultation|
16078077|NCT02323542|Other|Nutrition intervention with cereal products|acute evaluation of the effect of ingestion of cereal products differing by their Slowly Digestible Starch content
16078078|NCT02323529|Drug|Nitisinone|All patients in the study will first be put on twice daily dosing of nitisinone for 4 weeks. This will then be followed by once daily dosing of nitisinone for 4 weeks. The dose of nitisinone in the study will be the same as the one prescribed at completed screening visit. Dose will be 1-2 mg/kg body weight.
16078244|NCT02322216|Drug|Olopatadine Hydrochloride Ophthalmic Solution 0.1%|
16078079|NCT02323516|Drug|Acetylsalicylic acid + loperamide|In case of inefficiency in one month, according to predefined criteria, acetylsalicylic acid will be stopped and replaced by diosmectite.
16078080|NCT02323516|Drug|diosmectite + loperamide|In case of inefficiency in one month, according to predefined criteria, diosmectite will be stopped and replaced by acetylsalicylic acid.
16078081|NCT02323503|Device|CRT-D device replacement|
16078082|NCT02323490|Procedure|with microfractures|following meniscal repair, microfractures will be created on the intercondylar and outer part of femoral condyle (outside of joint surface), lateral or medial, respectively
16078083|NCT02323490|Procedure|without microfractures|standard procedure meniscal repair without augmentation.
16078084|NCT02323477|Biological|stem cell transplantation|Human allogeneic umbilical cord MSC or autologous BM-MNC transplantation
16078085|NCT02323464|Procedure|Open surgery for colorectal cancer|
16078086|NCT02323464|Procedure|Laparoscopic or robotic surgery|
16078087|NCT02323451|Device|Medical Chitosan|intra-articular injection
16078088|NCT02323451|Drug|Sodium Hyaluronate Injection|intra-articular injection
16078089|NCT02323438|Other|Usual Brand Cigarette|Combustible cigarette brand style smoked most frequently by subject
16078090|NCT02323438|Other|Electronic Cigarette #1|Electronic cigarette
16078091|NCT02323438|Other|Electronic Cigarette #2|Electronic cigarette
16078092|NCT02323438|Other|Leading U.S. Nicotine Gum|4 mg nicotine polacrilex gum
16078093|NCT02323425|Device|Remote ischemic postconditioning|Remote ischemic postconditioning（RIPC）treatment was performed by the inflating a cuff around bilateral arms to 180 mmHg with 5 cycles of 3 min inflation and 5 min relax alternation automatically.
16078094|NCT02323412|Drug|Amoxicillin (Amoksicillintrihydrat)|Amoxicillin tablets 750 mg 1x3 for 100 days (oral intake).
16078095|NCT02323412|Drug|Placebo|Placebo tablets 1x3 for 100 days (oral intake).
16078096|NCT02323399|Drug|Phenylephrine|one of six initial treatments Phenylephrine Hydrochloride Injection (PHI) will be initially administered to approximately 50 subjects as an intravenous bolus (IV-B) at Low (1 μg/kg), Med (3 μg/kg), or High (5 μg/kg) level; PHI will be initially administered to approximately 50 subjects as a continuous intravenous infusion (IV-I) at Low (0.25 μg/kg/min), Med (0.75 μg/kg/min), or High (1.25 μg/kg/min) level]; each initial treatment group will have two PK sampling schedules.
16078097|NCT02323386|Device|Primary Total Knee Arthroplasty (ATTUNE Knee System)|"The patient will undergo primary Total Knee ArthroplastY use ATTUNE Knee System. During surgery a navigation system will be used to record preoperative joint kinematics under different tests. During the test the 6 degrees of freedom (DOF) of the joint will be computed and shown to the surgeon; these are the femoral rotation and translation pattern against flexion ranges. Navigation system will be also used to monitor the implant positioning and possible surgical bias. Dynamic RSA will be used to analyze the in vivo kinematics of the prosthesis at 6 months follow-up.
~The above mentioned motion tests will be performed 3 times. The first 2 will be executed to gain comfort with the experimental set-up with no X-ray exposure. During the last data is collected."
16078098|NCT02323373|Drug|Tranexamic Acid - topical|Tranexamic acid is an antifibrinolytic agent that decreases perioperative blood loss, because it inhibits fibrinolysis by competing with lysine molecule in coupling sites in fibrinogen. In this study arm, the drug is administered topically on the wound.
16078099|NCT02323373|Drug|Placebo|100 ml of saline solution administered with anesthesia during 10 minutes
16078100|NCT02323373|Drug|Tranexamic Acid - intravenous|Tranexamic acid is an antifibrinolytic agent that decreases perioperative blood loss, because it inhibits fibrinolysis by competing with lysine molecule in coupling sites in fibrinogen. In this arm, the drug is administered intravenously.
16078101|NCT02323360|Radiation|SBRT|Patients with single nodule no more 5 cm or 1- 3 nodules no more 3 cm in diameter after incomplete TAE or TACE, are randomized to stereotactic radiotherapy in 3 or 6 daily fractions
16078102|NCT02323360|Procedure|TACE|Patients with single nodule no more 5 cm or 1- 3 nodules no more 3 cm in diameter after incomplete TAE or TACE, are randomized to a new cycle of TAE or TACE
16078103|NCT02323347|Other|Progesterone|Progesterone level
16078104|NCT02323334|Drug|LY3202626|administered orally
16078105|NCT02323334|Drug|Placebo (Part A, B, C)|administered orally
16078106|NCT02323334|Drug|Itraconazole|administered orally
16078107|NCT02323321|Device|Preservation of Hearts for Transplantation|Preserving and Assessing Expanded Criteria Donor Hearts for Transplantation
16078108|NCT02323308|Other|blood sampling|
16078109|NCT02323295|Radiation|Radiation|For surgical candidates, the standard treatment includes pre-operative radiation of 50.4 Gy, followed by a recovery period of approximately 4 to 5 weeks. After this surgery will take place. After approximately 6 weeks of recovery, to allow the surgical incision to heal, the patient is treated with another 19.8 Gy up to 27 Gy of radiation postoperatively depending on the final margin status (higher for gross residual disease) Non-surgical candidates receive 72 up to 77.14 Gy of radiation depending on the histology (72 Gy for osteosarcoma and chondrosarcoma and 77.4 Gy for chordoma)
16078110|NCT02323295|Procedure|Malignant Tumor Surgery|Surgery involves removing the malignant tumor in the sacrum in one piece, preferably with a cuff of normal tissue around the tumor
16078111|NCT02323282|Drug|ropivacaine|
16078112|NCT02323269|Drug|dimethyl fumarate|administered according to the local product label (i.e., Canadian Product Monograph).
16078113|NCT02323256|Other|Auditory steady-state response ASSR|comparison of ASSR amplitudes in response to amplitude-modulated sounds delivered at different intensities
16078114|NCT02323256|Other|Speech-ABR|
16078115|NCT02323256|Other|Acoustic Change Complex ACC|comparison of ACC complex in response to changes within speech stimulation
16078116|NCT02323256|Other|P1-N1-P2 complex and Mismatch Negativity MMN|comparison of amplitudes and latencies of P1-N1-P2 complex and MMN generated in response to the detection of changes in a series of auditory stimulation
16078117|NCT02323243|Device|"Allium  Bulbar Urethral Stent  (BUS) system"|
16078118|NCT02323230|Biological|DPX-Survivac|Immunotherapeutic vaccine targeting survivin antigen will be administered subcutaneously
16078119|NCT02323230|Drug|Cyclophosphamide|Low dose cyclophosphamide will be taken by mouth
16078120|NCT02323217|Radiation|[11C]BU99008|Baseline Scan, Test-ReTest or Dosimetry
16078121|NCT02323217|Drug|Idazoxan|Idazoxan block of [11C]BU99008
16078125|NCT02323191|Drug|Atezolizumab|Participants will receive atezolizumab intravenously at a fixed dose of 1200 milligram (mg) q3w.
16078126|NCT02323191|Drug|Emactuzumab|Participants will receive emactuzumab intravenously in ascending dose levels with a starting dose of 500 mg.
16078127|NCT02323178|Drug|eltrombopag|initial dose of 50 mg once daily, then the dose can be sequentially increased every 2 weeks up to a maximum dose of 300mg/day
16078128|NCT02323165|Other|Molecular Detection of Bacteria in the Bloodstream|Extracted nucleic acid will be tested by Polymerase Chain Reaction (PCR) with universal bacterial 16 S amplifiers from known 16 S sequences that routinely contaminate reagents. Polymerase Chain Reaction (PCR) will be performed with both TaqMan assays to provide quantitative copy numbers, as well as traditional PCR that can produce products that can be sequenced to confirm bacterial species identification.
16078129|NCT02323152|Behavioral|psychoeducation|Usual treatment + psychoteraphy focused on problem solving (6 sessions). The psychoeducational programme consists of 6 sessions of 60 minutes, one per week.
16078130|NCT02323152|Other|Standard care|Puerperal control with their doctor. This group will also be interviewed with the same frecuency of the experimental group but will not receive a psichologycal treatment
16078131|NCT02323139|Drug|Azacitidine and LDE255|Azacitidine at maximum tolerated dose. LDE255 at dose escalation (200, 400 or 800 mg)
16078132|NCT02323126|Drug|EGF816|
16078133|NCT02323126|Drug|INC280|
16078134|NCT02323126|Drug|Nivolumab|
16078135|NCT02323113|Drug|TAK-659|TAK-659 tablets.
16078136|NCT02323100|Drug|Ravicti low dose|8 am, 4pm and midnight
16078137|NCT02323100|Drug|Ravicti high dose|8 am, 4pm and midnight
16078138|NCT02323100|Drug|Placebo|8 am, 4pm and midnight
16078139|NCT02323087|Device|FLEXICULT™ SSI-Urinary Kit|Urine culture and sensitivity testing will be performed on the intervention group by means of a POCT, the FLEXICULT™ SSI-Urinary Kit. The kit is designed as an ordinary Petri dish but with higher sides. The Petri dish is divided into 6 compartments: 1 large one for quantitative analysis and 5 smaller ones for susceptibility testing (Fig. 1). The agar in each of the smaller compartments contains 1 of 5 antimicrobials: trimethoprim, sulfamethoxazole, ampicillin, nitrofurantoin and mecillinam. The agar plate is flooded with the urine specimen for a couple of seconds and then incubated at 35°C over night. The following day the plate is read. When reading the compartment for quantitative analysis the lower limit is:103 colony-forming units (cfu) per milliliter.
16078140|NCT02323087|Device|ID FlexicultTM|Point of care culture will be performed using ID FlexicultTM,which is a chromogenic agar plate for identification and quantitation of urinary tract pathogens. The agar plate is for cultivation of urine, which makes it possible to identify the bacteria and quantitate the amount of bacteria. Based on bacterial colony color and size can be determined which bacteria are involved. For example, an E. coli bacteria will grow with big red colonies, and Enterobacter sp. will grow with large dark blue / purple colonies. The sample is seeded with a 10 uL inoculation needle, the lid is applied and the agar plate incubated with the lid down at 35 0C overnight. The plate is read the next day
16078141|NCT02323074|Procedure|Brain Computer Interface|
16078142|NCT02323061|Procedure|BCI using EEG signals|A robot hand will be used and controlled by the system in real time based on EEG pattern for identification of motion intention for hand movements in the cortex.
16078143|NCT02323048|Drug|methamphetamine|: Twenty milligrams of MA (Desoxyn; Lundbeck Inc) tablets will be crushed and placed in 10 ml of Ora-Sweet syrup. Placebo drinks will consist of 10 ml of Ora-Sweet alone.
16078144|NCT02323048|Drug|placebo|Placebo (sugar pill)
16078145|NCT02323035|Device|Headgear|Investigative Headgear with CPAP Mask.
16078146|NCT02323022|Drug|IAC regimen|Induction treatment for initially diagnosed AML with IAC regimen, including Cladribine 5mg/msq/d (d1-5), Ara-C 100mg/msq/d(d1-7) and IDA 8mg/msq/d (d1-3)
16078147|NCT02323022|Drug|High-dose IA regimen|Induction treatment for initially diagnosed AML with IAC regimen, including Ara-C 100mg/msq/d (d1-7) and IDA 12mg/msq/d (d1-3)
16078148|NCT02323022|Drug|Intermediate-dose IA regimen|Induction treatment for initially diagnosed AML with IAC regimen, including Ara-C 100mg/msq/d (d1-7) and IDA 10mg/msq/d (d1-3)
16078149|NCT02323009|Device|Esophageal Balloon|Esophageal balloon was used to measure esophageal pressure (Paux) which was used as an estimate of pleural pressure. Transpulmonary pressure (Ptp) was calculated as the difference between airway pressure (Pao) and Paux. Applied PEEP was then adjusted to overcome negative Ptp which we maintained between 0 to 10 cm H20. All measurements were made at end-expiration.
16078150|NCT02323009|Other|Cstat|PEEP was adjusted to achieve the best CStat in this group of patients
16078151|NCT02322996|Other|questionnaires|The deep phenotyping of acute pain will be conducted using the oral surgery model. Before surgery, subjects will undergo QST and answer short-form questionnaires related to pain and activities of daily living.
16078152|NCT02322983|Behavioral|Control of Stress|To control stress were measured (at different times: T1, T2, T3 and T4) Venham's Score, Heart Rate, Respiratory Rate, and the titration of gases.
16078153|NCT02322970|Device|transcranial Doppler|Comparison of non invasive intracranial pressure (through use of transcranial Doppler ) vs invasive monitoring (through insertion of intracerebral catheters) with the purpose of comparing these two techniques in terms of specificity and sensitivity.
16078154|NCT02322957|Drug|FV-100|Subjects will be randomized to one of two treatment sequences: AB or BA.
16078155|NCT02322944|Behavioral|Quality improvement strategies and tools|Training in standardized treatment pattern; building quality management team and determining improvement goals; tools (a wristband in order to remind all medical staff involved in the treatment process; workflow posters and cards; a CRF including a flowchart to inform the management steps); periodical quality feedback report and regular quality meeting; study website serving as the communication platform.
16078156|NCT02322944|Behavioral|Process optimization|Examining local hospitals' workflow to determine the key link affecting the rate of reperfusion therapy and its timeliness (such as thrombolytic drug preparation, cardiac catheterization laboratory preparation, transferring from the ER to the cath lab, interventional medical team gathering, etc.) and systems (such as pre-paid policy for thrombolysis or PPCI)
16078204|NCT02322554|Biological|Cellular and tissue based products|Procedure: Application of device or biological to wounds
16078241|NCT02322242|Drug|Perineural dexamethasone|Perinerual administration of dexamethasone (4mg)
16078242|NCT02322229|Drug|Ocriplasmin 0.125 mg in a 0.1 mL volume|
16078157|NCT02322931|Procedure|Intra-operative C-arm CT imaging|"Two intra-operative C-arm 3D reconstruction scans with the Ziehm Vision FD Vario 3D immediately after treatment implantation, once with the TRUS probe inserted and once with the TRUS probe removed. This involves approximately 10 fluoroscopy snapshots of the prostate.
~Two TRUS Sagittal B-mode sweeps and two TRUS axial B-mode sweeps, once mid-way, i.e. after implanting a sub-set of the seeds, and once at the end of the implantation procedure.
~One Cine loop C-arm scan in the sagittal plane while retracting the probe.
~One 3D C-arm scan immediately after the treatment, with the TRUS probe removed and the patient in the supine position (i.e. legs down)."
16078158|NCT02322918|Genetic|Blood samples for whole genomic/transcriptomic sequencing|Participant will receive one blood draw whereby two samples will be extracted. If the participant wishes to participate in the study but is fearful of needles, they may be given the option to provide a saliva sample. A retrospective medical chart review will be performed after participant is discharged from BCPP in order to obtain a full phenotype. Genotyping of BDNF and COMT will be performed. Protein levels of BDNF will be determined. The remaining blood or saliva samples will be stored over the long-term in a biorepository at the BC Mental Health and Addictions Research Institute. A retrospective medical chart review will be completed after the participant is discharged.
16078159|NCT02322905|Behavioral|Emotion Regulation Therapy|8 sessions of ERT
16078160|NCT02322892|Drug|Thiamine|200 mg thiamine in 50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)
16078161|NCT02322892|Drug|Normal saline solution|50 mL normal saline once immediately before surgery and once immediately after (at arrival in the intensive care unit)
16078162|NCT02322879|Drug|First Treatment Period|(duration: 14 days) Subjects will be randomized to receive either of the 2 interventions (4 grams of solid acetaminophen formulation for two weeks vs. 4 grams of solid acetaminophen formulation + 70 mg/kg/day of liquid propylene glycol)
16078163|NCT02322879|Other|Washout|(duration: 14 days) At the end of the First intervention period all participants will enter a washout period.
16078164|NCT02322879|Drug|Second Treatment Period|(duration: 14 days) At the end of the washout period, participants will receive the alternative intervention.
16078165|NCT02322866|Drug|Sarecycline|1.5 mg/kg/day taken orally at the same time each day.
16078166|NCT02322866|Drug|Placebo|Placebo-matching sarecycline tablets, taken orally at the same time each day.
16078167|NCT02322853|Drug|Tamoxifen|hormonotherapy
16078168|NCT02322853|Drug|Ralimetinib (LY2228820 dimesylate)|
16078169|NCT02322814|Drug|Cobimetinib|Cobimetinib will be administered orally at a dose of 60 milligrams (mg) per day, once a day, on Day 3 through Day 23 of each 28-day treatment cycle.
16078170|NCT02322814|Drug|Paclitaxel|Paclitaxel will be administered at a dose of 80 milligrams per square meter (mg/m^2) by intravenous (IV) infusion on Day 1, Day 8, and Day 15 of each 28-day cycle according to prescribing information.
16078171|NCT02322814|Drug|Placebo|Placebo matching to cobimetinib will be administered orally, once a day, on Day 3 through Day 23 of each 28 day treatment cycle.
16078172|NCT02322814|Drug|Atezolizumab|Atezolizumab will be administered to Cohorts II and III at a dose of 840 mg IV every 2 weeks on Days 1 and 15 of each 28-day treatment cycle.
16078173|NCT02322814|Drug|Nab-Paclitaxel|Nab-Paclitaxel will be administered to Cohort III according to the local prescribing information at a starting dose of 100 mg/m^2 by IV infusion on Days 1, 8, and 15 of each 28 day cycle.
16078174|NCT02322788|Drug|Terbutaline sulphate|Bricanyl Turbuhaler M2
16078175|NCT02322788|Drug|Terbutaline sulphate|Bricanyl Turbuhaler M3
16078176|NCT02322788|Drug|Placebo for terbutaline sulphate|Placebo Turbuhaler M2
16078177|NCT02322788|Drug|Placebo for terbutaline sulphate|Placebo Turbuhaler M3
16078178|NCT02322775|Biological|Benralizumab|Benralizumab administered subcutaneously every 4 weeks
16078179|NCT02322775|Biological|Placebo|Placebo administered subcutaneously every 4 weeks
16078180|NCT02322749|Drug|selumetinib 75mg single dose|3 blue capsules of 25 mg given as a single dose
16078181|NCT02322749|Drug|selumetinib 75mg single dose|3 capsules of 25 mg given as a single dose
16078182|NCT02322749|Drug|selumetinib 75mg single dose|3 capsules of 25 mg given as a single dose
16078183|NCT02322710|Device|Urgotul: Low-adherent dressing|
16078184|NCT02322710|Device|TulleGras M.S.: Vaseline gauze|
16078185|NCT02322697|Drug|Intravenous administration of L-carnitine|Chronic intravenous administration of L-carnitine (1000mg on each dialysis session) for 1 year in hemodialysis patients
16078186|NCT02322684|Device|Air-Q|Air-Q/Intubating Laryngeal Airway (air-Q/ILA, Cookgas LLC, St. Louis, MO, USA) is an extra glottis airway (EGA) used as a primary airway device or as an adjunct to tracheal intubation. The air-Q/ILA is available as a disposable (air-Q) or nondisposable (ILA) device
16078187|NCT02322671|Drug|Reference Montelukast|It is available as pink, round, bi-convex-shaped chewable tablet of reference 5 mg montelukast sodium (innovator product). that has to be placed on the tongue and chewed immediately.
16078188|NCT02322671|Drug|Test 1 Montelukast|It will be provided as pink, round, bi-convex-shaped chewable tablet of test formulation 1: 5mg montelukast sodium (GW483100) that has to be placed on the tongue and chewed immediately.
16078189|NCT02322671|Drug|Test 2 Montelukast|It will be provided as pink, round, bi-convex-shaped chewable tablet of test formulation 2: 5mg montelukast sodium (GW483100) that has to be placed on the tongue and chewed immediately.
16078190|NCT02322658|Drug|Eszopiclone Tablets 3 mg|
16078191|NCT02322645|Drug|Eszopiclone Tablets 3 mg|
16078192|NCT02322632|Drug|Paricalcitol Capsules, 4 mcg|Paricalcitol Capsules, 4 mcg of Dr. Reddy's Laboratories Limited
16078193|NCT02322619|Drug|Moxifloxacin Tablets 400 mg|Moxifloxacin Tablets 400 mg of Dr. Reddy's Laboratories Limited
16078194|NCT02322606|Drug|TAK-137 5 mg tablet, TAK-137 placebo tablet|
16078195|NCT02322606|Drug|TAK-137 5 mg tablet, TAK-137 placebo tablet|
16078196|NCT02322606|Drug|TAK-137 5 mg tablet, TAK-137 placebo tablet or TAK-137 0.5 mg tablet, TAK-137 placebo tablet|
16078197|NCT02322606|Drug|TAK-137 5mg tablet, TAK-137 placebo tablet|
16078198|NCT02322606|Drug|TAK-137 5 mg tablet, TAK-137 placebo tablet|
16078199|NCT02322606|Drug|TAK-137 5mg tablet, TAK-137 placebo tablet|
16078200|NCT02322593|Drug|TAS-118 plus Oxaliplatin|
16078201|NCT02322593|Drug|S-1 plus Cisplatin|
16078202|NCT02322580|Drug|etanercept|
16078205|NCT02322541|Other|Garlic Intervention|Participants will consume an Allium-free controlled diet for 3 days. On the 4th day, they will consume a test meal containing garlic followed by blood and urine collections for 10 hours. On the 5th day, participants will have a fasting blood and urine collection.
16078206|NCT02322528|Drug|Administration of Lotemax|An FDA approved drug (Lotemax) will be administered to induce an inflammatory mediated response in both eyes.
16078207|NCT02322515|Other|Intervention taping|A rigid patellar taping will be used for the correction in lateralization of the patella and more stabilization of the knee.
16078208|NCT02322515|Other|Placebo Taping|A rigid patellar taping will be used in the vertical position and without no correction in lateralization of the patella and/or stabilization of the knee.
16078209|NCT02322502|Drug|Desflurane|inhalation with laryngeal mask to maintain anaesthesia
16078210|NCT02322502|Drug|Sevoflurane|inhalation with laryngeal mask to maintain anaesthesia
16078211|NCT02322502|Drug|propofol|intravenous injection to maintain anaesthesia
16078212|NCT02322489|Device|Microcurrent Therapy|Several electrodes are placed over the muscles involved in the provocative task. The microcurrent therapy is then started and lasts for one hour.
16078213|NCT02322489|Device|Sham microcurrent therapy|Several electrodes are placed over the muscles involved in the provocative task. The microcurrent therapy is then started but lasts only for five seconds.
16078214|NCT02322476|Other|No intervention will be performed|No intervention will be performed
16078215|NCT02322463|Drug|Arab children|Treatment with Oxycodone
16078216|NCT02322450|Drug|QGC001|
16078217|NCT02322450|Drug|Placebo|
16078218|NCT02322437|Other|Home treatment|Patients are treated at home whenever possible and appropriate
16078219|NCT02322437|Other|Treatment As Usual|Patients are treated at a mental hospital
16078220|NCT02322424|Procedure|pancreaticoduodenectomy|
16078221|NCT02322411|Device|Isometric Progressive Resistance Oropharyngeal Therapy|Isometric Progressive Resistance Oropharyngeal Therapy is an approach to oropharyngeal strengthening. This particular use of I-PRO therapy will be facilitated by the Swallow Strong device.
16078222|NCT02322411|Behavioral|Compensatory approaches|
16078223|NCT02322398|Drug|rFSH plus rLH|150-300 IU/d rFSH plus 75-150 IU/d rLH in 2:1 ratio
16078224|NCT02322398|Drug|hMG|150-300 IU/d hMG
16078225|NCT02322372|Drug|Femoral blockade|Spinal anesthesia with heavy bupivacaine combined with femoral blockade with bupivacaine
16078226|NCT02322372|Drug|Intrathecal anesthesia|Spinal anesthesia with heavy bupivacaine
16078227|NCT02322346|Other|Group S|"Peritonsillar infiltration with saline Additional remifentanil 1 µgr kg-1 IV was administered to the patients if HR was increased by 25 % of the basal value.
~During postoperative period, symptoms such as pain, fever and dysphagia, adverse affects such as nausea and vomiting and hemorrhage were evaluated. Pain was evaluated by FLACC (Faces, leg, activity, cry, consolability), FPRS (Faces pain rating scale) ve Wong-Baker facies scales at postoperative 0, 30 and 60 minutes and 2, 6, 12 and 24 hours. Total analgesic consumption during the postoperative period were recorded. If the patients had no complication, they were discharged at the postoperative 24th hour."
16078228|NCT02322346|Drug|Group LL|"Peritonsillar infiltration with low-dose of levobupivacaine 0.25%. Additional remifentanil 1 µgr kg-1 IV was administered to the patients if HR was increased by 25 % of the basal value.
~During postoperative period, symptoms such as pain, fever and dysphagia, adverse affects such as nausea and vomiting and hemorrhage were evaluated. Pain was evaluated by FLACC (Faces, leg, activity, cry, consolability), FPRS (Faces pain rating scale) ve Wong-Baker facies scales at postoperative 0, 30 and 60 minutes and 2, 6, 12 and 24 hours. Total analgesic consumption during the postoperative period were recorded. If the patients had no complication, they were discharged at the postoperative 24th hour."
16078229|NCT02322346|Drug|Group HL|"Peritonsillar infiltration with high dose of levobupivacaine 0.5%. Additional remifentanil 1 µgr kg-1 IV was administered to the patients if HR was increased by 25 % of the basal value.
~During postoperative period, symptoms such as pain, fever and dysphagia, adverse affects such as nausea and vomiting and hemorrhage were evaluated. Pain was evaluated by FLACC (Faces, leg, activity, cry, consolability), FPRS (Faces pain rating scale) ve Wong-Baker facies scales at postoperative 0, 30 and 60 minutes and 2, 6, 12 and 24 hours. Total analgesic consumption during the postoperative period were recorded. If the patients had no complication, they were discharged at the postoperative 24th hour."
16078230|NCT02322333|Drug|MLD10|
16078231|NCT02322333|Drug|Placebo|
16078232|NCT02322320|Drug|Lenalidomide|In BMT CTN 0702, maintenance therapy with lenalidomide started at 10 mg daily for three months and increased to 15 mg daily. The duration of maintenance was three years in all treatment arms. Lenalidomide will be administered initially at the patient's last documented dose prior to discontinuation of BMT CTN 0702 lenalidomide maintenance therapy. Cycle duration is 28 days. Patients will continue lenalidomide until disease progression, or discontinuation due to toxicity, death, or withdrawal from the study.
16078233|NCT02322307|Other|HealthPROMISE users|"Patients using HealthPROMISE will be asked to use the application once every two weeks at a minimum to provide updates on health information. Providers can use the data entered by patients in real time. Patients will get alerts requesting them to contact their providers if their quality of life scores fall below a certain threshold or their symptoms scores are worrisome. Both patients and physicians are also sent regular notifications with data about their own health or health of their patient panel respectively. Both patients and providers are encouraged to use existing communication tools (phone, office visits, personal health records) since direct patient-physician messaging is not provided in the HealthPROMISE platform. Reminders through app, email and SMS will be used to facilitate patient engagement.
~Physicians will also be encouraged to check the physician panel to see how patients are doing through weekly updates and monthly quality improvement meetings."
16078234|NCT02322307|Other|Control Group|In order to eliminate a placebo effect, patients in both groups will get an app customized for IBD. Physician and rest of care team will not be blinded since they will use HealthPROMISE dashboard to get alerts and notifications.
16078235|NCT02322294|Dietary Supplement|Glucodia™|
16078236|NCT02322294|Other|Placebo|
16078237|NCT02322281|Drug|Rociletinib|
16078238|NCT02322281|Drug|Pemetrexed or gemcitabine or paclitaxel or docetaxel|
16078239|NCT02322268|Dietary Supplement|Cosmos Caudatus|15g of Cosmos caudatus consumed with lunch or dinner
16078240|NCT02322242|Drug|Systemic Dexamethasone|Intravenous infusion of dexamethasone (4mg)
16078245|NCT02322216|Drug|Olopatadine 0.2% Vehicle|Inactive ingredients used as placebo comparator
16078246|NCT02322203|Dietary Supplement|Niacin Extended Release|Subjects will receive a 2 week supply of the dietary supplement Rugby Extended Release Niacin (250 mg/tablet) Niacin and will be instructed to take 2 tablets per day (500 mg/day) for the first seven days and then increase to 4 tablets per day (1000 mg/day) during the following 7 days. Subjects will then be escalated to 2000 mg/day for 14 weeks.
16078247|NCT02322190|Procedure|Extracorporeal Photopheresis (ECP)|Twice weekly for 1 month or Twice every other week for 2 months or Twice during one week per month for 4 months for a total of up to 7 months of treatment.
16078248|NCT02322190|Drug|Methoxsalen|Sterile solution used in conjunction with photopheresis procedure.
16078249|NCT02322138|Other|Experimental 1 Infant Formula|Ready to feed infant formula to be fed ad-libitum
16078250|NCT02322138|Other|Experimental 2 Infant Formula|Ready to feed infant formula to be fed ad-libitum
16078251|NCT02322138|Other|Reference Group|Breast fed ad libitum
16078252|NCT02322125|Device|ReWalk|Intensive training with the ReWalk to negotiate smooth ground, rough terrain indoors and outdoors, ascending and descending slopes and steps, in a home setting and in the community.
16078253|NCT02322112|Other|Microcrystalline Cellulose Supplementation|Fifty overweight and mildly obese subjects will supplement their normal dietary intake with a significant yet tolerable amount of MCC (Females: 25 g; Males: 35 g) daily for six consecutive weeks.
16078254|NCT02322112|Other|Acacia Gum Supplementation|Seventy five overweight and mildly obese subjects will supplement their normal dietary intake with a significant yet tolerable amount of AG (Females: 25 g; Males: 35 g) daily for six consecutive weeks.
16078255|NCT02322112|Other|Resistant Starch Type 4 Supplementation|Seventy five overweight and mildly obese subjects will supplement their normal dietary intake with a significant yet tolerable amount of RS4 (Females: 25 g; Males: 35 g) daily for six consecutive weeks.
16078256|NCT02322099|Drug|Alendronate|alendronate 70 mg tablets to be administered weekly for a total of 14 weeks, commencing 2 weeks prior to ART initiation
16078257|NCT02322099|Drug|Placebo|Sugar pill manufactured to mimic alendronate 70 mg tablet administered weekly for a total of 14 weeks, commencing 2 weeks prior to ART
16078258|NCT02322099|Dietary Supplement|calcium carbonate and colecalciferol|Calcium carbonate 1250 mg (equivalent to 500 mg of elemental calcium) and colecalciferol 400 iu (equivalent to 10 micrograms of vitamin D3) tablets administered twice daily for a total of 14 weeks, commencing 2 weeks prior to ART initiation
16078259|NCT02322099|Drug|Tenofovir disoproxil|Emtricitabine / tenofovir disoproxil fumarate 200 / 300 mg tablet administered once-daily with food (open-label) commencing 2 weeks after alendronate initiation and continuing for 48 weeks
16078260|NCT02322086|Drug|Topical Rose Bengal, 0.005%|Subjects will apply PH-10 vehicle daily for 28 consecutive days followed by active PH-10 daily for 28 consecutive days to their plaque psoriasis areas on the trunk or extremities (excluding palms, soles, scalp, facial and intertriginous sites).
16078262|NCT02322060|Procedure|Ovariotomy|Remove one ovary (maybe both ovaries depending on the condition) by laparoscopic surgery or by laparotomy in some cases.
16078263|NCT02322060|Procedure|Activate dormant follicles|Cut ovary into small cubes, which are then cultured with medium containing BPV(pic), a PTEN inhibitor, and 740YP, an activator of phosphoinositol 3 kinase, to activate dormant follicles for 2 days before transplantation.
16078264|NCT02322060|Procedure|Ovary tissue transplantation|After extensive washing to remove drugs, the ovary cubes are transplanted beneath the membrane of both Fallopian tubes and the remaining ovary under laparoscopic surgery.
16078265|NCT02322060|Procedure|Ovarian superficial cut|Superficial cut of the ovarian cortex by laparoscopy or laparotomy
16078266|NCT02322047|Drug|Prazosin|Prazosin Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
16078267|NCT02322047|Drug|Naltrexone|Naltrexone Dosing Days 1-42: 50mg @ 9PM
16078268|NCT02322047|Drug|Placebo (Prazosin)|Placebo Dosing Days 1-2: 1 mg @ 9PM Days 3-4: 1 mg @ 9AM, 3PM, 9PM Days 5-7: 2 mg @ 9AM, 3PM, 9PM Days 8-10: 2mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 11-14: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM Days 15-42: 4mg @ 9 AM, 3 PM; 8mg @ 9 PM
16078269|NCT02322047|Drug|Placebo (Naltrexone)|Placebo Dosing Days 1-42: 50mg @ 9PM
16078270|NCT02322034|Other|Interval Training|Exercise training protocol (high intensity, interval training) is followed by the enrolled patients on hospital outpatient-based regimen 3 times/week for 24 weeks. The high intensity group will perform interval cycling for 4 minutes with 1-minute rest between intervals. High intensity exercise will be 90-95% peak heart rate. The exercise intensity will be established, and maintained throughout the 24-week exercise training period, by calculating the heart rate range as a percentage of maximum (90-95%) as obtained from the most recent cardiopulmonary exercise test. Every 4 weeks during the training program, the exercise intensity will be titrated to the same relative percentage of maximum (90-95%) as it is assumed most patients will become fitter over the training period.
16078271|NCT02322021|Drug|E2609|Each participant will receive 2 tablets, which when combined will make up the required doses of E2609 or placebo, to be administered orally once per day (QD) with food.
16078272|NCT02322021|Drug|Placebo|Each participant will receive 2 tablets, which when combined will make up the required doses of E2609 or placebo, to be administered orally once per day (QD) with food.
16078273|NCT02322008|Biological|infliximab and adalimumab|In this retrospective, observational study, no interventions were undertaken by the researchers.
16078274|NCT02321982|Other|Same-day preoperative consultation|Preoperative consultation occurs on the same day as Mohs surgery
16078275|NCT02321969|Dietary Supplement|GTE (green tea extract)|6 GTE tablets per day. Daily dose is equivalent of 9 cup-of-green tea per day (0.9 g/day GTE, 0.6 g/day epigallocatechin gallate [EGCG]).
16078276|NCT02321956|Diagnostic Test|Ultrasound|Using ultrasound to determine the size of endotracheal tube
16078277|NCT02321930|Drug|tofacitinib 5mg po bid|
16078278|NCT02321917|Device|MECC system with rheoparin coating|MECC system for extracorporeal circulation equipped with rheoparin coating.
16078279|NCT02321904|Procedure|Corneal Confocal Microscopy|Close-up pictures of the front part of the eye (the cornea)
16078945|NCT02316964|Other|laboratory biomarker analysis|Correlative studies
16078280|NCT02321904|Procedure|Nerve Conduction Studies|The following assessments will be made: a) amplitude of nerve action potential (μV) and conduction velocity (m/s) of the sural sensory nerve by antidromic stimulation; b) motor nerve conduction velocity (m/s), maximum M-wave amplitude (mV) and motor nerve distal latency (ms) of the peroneal motor nerve; and c) tibial nerve conduction study will also be obtained if tolerated.
16078281|NCT02321904|Procedure|Quantitative sensory testing|Standardized vibratory and thermal stimulation levels applied to the subject's non-dominant big toe.
16078282|NCT02321904|Procedure|Neuropathy Symptom Score|A list of 18 motor, sensory and autonomic symptoms encountered in a diabetic patients with neuropathy obtained by interview.
16078283|NCT02321904|Procedure|Clinical nerve examination|Summated score of the lower extremities. Neurological examination assessing muscle strength, knee and ankle reflexes, sensation in the great toes will be evaluated for light touch-pressure, temperature, pin-prick, vibratory sense and joint position sense.
16078284|NCT02321891|Device|NeuroConn DC Stimulator Plus, tDCS|transcranial electrical stimulation intervention with two experimental protocols
16078285|NCT02321878|Drug|liraglutide|"Liraglutide (Victoza®) will be prescribed by the physician under normal clinical practice conditions.
~No treatment given."
16078286|NCT02321865|Drug|NPC-02|
16078287|NCT02321852|Drug|Triflusal|Once daily oral administration of 600 mg triflusal Disgren® for 7 days.
16078288|NCT02321852|Drug|Placebo|Once daily oral administration of placebo mannitol for 7 days
16078289|NCT02321839|Drug|Intraviteal Ranibizumab 0.5mg|Intraviteal Ranibizumab 0.5mg
16078290|NCT02321826|Behavioral|Music|Participants choice among 4 genres of music matched on music characteristics
16078291|NCT02321826|Behavioral|Audiobook|Participants choice among 4 types of audiobooks
16078292|NCT02321813|Behavioral|quality of life pathway|Quality of life measurement, diagnosis and tailored therapy (pain therapy, psychotherapy, social support, nutrition, stoma care, physiotherapy, fitness)
16078293|NCT02321813|Other|placebo control|Quality of life measurement
16078294|NCT02321800|Drug|Cefiderocol|2000 mg intravenously every 8 hours for 7 to 14 days; dose adjustments for participants with reduced renal function (estimated CrCl ≤ 70 mL/minute) and/or body weight (< 70 kg) included every 6-hour dosing intervals and/or reduced doses.
16078295|NCT02321800|Drug|Imipenem/cilastatin|1000 mg of each intravenously every 8 hours for 7 to 14 days; dose adjustments for participants with reduced renal function (estimated CrCl ≤ 70 mL/minute) and/or body weight (< 70 kg) included every 6-hour dosing intervals and/or reduced doses.
16078296|NCT02321787|Procedure|Ultrasound for confirmation of successful caudal block|Use of ultrasound for confirmation of successful caudal block
16078297|NCT02321761|Drug|Amantadine hydrochloride|Drug dosages: day 0-14 no drug will be given Days 15-21 100 mg Days 22-28 200 mg Days 29-42 400 mg Days 43-56 200 day 57-70 no drug will be given
16078298|NCT02321748|Drug|Montelukast|
16078299|NCT02321748|Drug|ASP2151|
16078300|NCT02321735|Behavioral|Quality of life questionaire|Patients will participate in a QOL questionaire followed by a phone interview
16078301|NCT02321709|Drug|SAR113244|Pharmaceutical form:solution for injection Route of administration: subcutaneous
16078302|NCT02321709|Drug|placebo|Pharmaceutical form:solution for injection Route of administration: subcutaneous
16078303|NCT02321696|Device|Acupuncture|
16078304|NCT02321696|Other|Physiotherapy and eccentric exercise|
16078305|NCT02321696|Other|Watchful waiting and eccentric exercise|
16078306|NCT02321696|Other|eccentric exercise|
16078307|NCT02321683|Device|Taperloc|Femoral stem with electrochemical deposition of hydroxyapatite
16078308|NCT02321670|Procedure|End-to-end|Excision of the stricture and end-to-end anastomosis of the urethra.
16078309|NCT02321670|Procedure|Graft|Incision of stricture and grafting procedure with buccal mucosa where the corpus spongiosum is not divided
16078310|NCT02321657|Other|iPad app containing art, music and games|An iPad app that takes demographic information on a child and suggests suitable art, music and games for use by the anaesthetist and nurse to distract them during anaesthetics
16078311|NCT02321657|Other|Toys, books and games|Games, books and toys used to distract
16078312|NCT02321644|Drug|CC-90001|CC-90001 Active-ingredient-in-capsule and formulated tablet
16078313|NCT02321631|Dietary Supplement|EPA-enriched supplement|EPA-enriched supplement is given to the patients for 3 weeks (1 week prior to surgery and 2 weeks post surgery). The supplement composes of 2.2 gm of EPA and 630 kcal daily.
16078314|NCT02321631|Dietary Supplement|standard formula supplement|The standard formula supplement is given to the patients for 3 weeks (1 week prior to surgery and 2 weeks post surgery). The supplement is 630 kcal daily without EPA.
16078315|NCT02321618|Behavioral|BP measurement & pharmacy|Blood pressure monitoring by barber, blood pressure medication management by pharmacist, role model posters encouraging program participation
16078316|NCT02321618|Behavioral|BP educational materials|Exposure to hypertension educational materials
16078317|NCT02321605|Behavioral|e-BPS|"Participants are asked to write and imagine about a future in which they have reached all their goals and they have developed all their potentialities in four different domains: personal, professional, social and health domain.
~They carry out the exercise in a Positive Technology System called the Book of Life, which has shown efficacy in the enhancement of positive mood (Baños, Etchemendy, Farfallini, García-Palacios, Quero & Botella, 2014). This application looks like a personal diary, where participants can write all that they want and these essays are supported by multimedia content (pictures, songs and videos). Additionally, they can continue doing the exercise in a web platform in which they can visualize all the content they had developed previously."
16078318|NCT02321605|Behavioral|Daily Activities|Participants are asked to think and write about all that they have done the last 24 hours. They carry out the exercise in a powerpoint document, where they can record all the activities, situations and thoughts.
16078319|NCT02321592|Drug|AFM13|
16078320|NCT02321579|Dietary Supplement|vitamin B-6|50 mg/d
16078321|NCT02321579|Dietary Supplement|Glutathione|500 mg/d
16078322|NCT02321579|Dietary Supplement|Dextrins|50 mg/d
16078323|NCT02321566|Device|Epidural Motor Cortex Stimulation|
16078324|NCT02321553|Other|Brown rice|brown rice cake
16078325|NCT02321553|Other|White rice|white rice cake
16078326|NCT02321540|Drug|Ibrutinib|"Part 1 Starting level of Ibrutinib: 560 mg by mouth daily in a 28 day cycle.
~Part 2 Starting level of Ibrutinib: Maximum tolerated dose from Part 1 or 840 mg daily."
16078327|NCT02321527|Drug|Perflutren Protein-Type A Microspheres Injectable Suspension|Participants receive a subdermal periareolar injection of 0.2 - 0.5 cc of microbubble contrast Perflutren Protein-Type A Microspheres Injectable Suspension (OPTISON™) before breast ultrasound.
16078328|NCT02321527|Device|Contrast-Enhanced Ultrasound (CEUS)|Ultrasound images of breast and videos of tumor and lymph nodes in underarm area taken after Perflutren Protein-Type A Microspheres Injectable Suspension injection.
16078329|NCT02321527|Procedure|Biopsy + Radioactive Seed Placement|Biopsy of sentinel lymph node that was identified in ultrasound performed, and a titanium clip marker inserted into the node. After biopsy, a radioactive seed may be inserted into the node to allow surgeon to find and remove it during surgery.
16078330|NCT02321527|Behavioral|Phone Call|Participant called by phone 30 days after seed is removed to check for any side effects. This phone call should take about 10 minutes.
16078331|NCT02321514|Device|Tendyne Mitral Valve System|Patients will undergo transcatheter mitral valve replacement using Tendyne Mitral Valve system
16078332|NCT02321501|Drug|Ceritinib|Given PO
16078333|NCT02321501|Drug|Everolimus|Given PO
16078334|NCT02321501|Other|Laboratory Biomarker Analysis|Correlative studies
16078335|NCT02321501|Other|Pharmacological Study|Correlative studies
16078336|NCT02321475|Drug|EGb761®|
16078337|NCT02321462|Drug|Eziclen|Eziclen solution administered orally as split-dose the day before and on the day of colonoscopy.
16078338|NCT02321462|Drug|Fortrans®|Fortrans® solution administered orally as split-dose the day before and on the day of colonoscopy.
16078339|NCT02321436|Biological|Botulinum toxin type A|Subjects to receive Dysport® 500U administered intramuscularly in the targeted upper limb.
16078340|NCT02321436|Drug|Placebo|Placebo administered intramuscularly in the targeted upper limb.
16078341|NCT02321410|Other|Contrast enhanced ultrasound of the carotid plaque|visual grading of neovessel
16078342|NCT02321410|Other|Dynamic contrast-enhanced carotid plaque MRI|quantitative analysis of gadolinium enchantment in a region of interest
16078343|NCT02321397|Drug|Oxycodone|
16078344|NCT02321397|Drug|Naloxone|Prolonged Release Tablets
16078345|NCT02321384|Drug|Placebo|Placebo matched to RO6889678 will be administered orally as a single dose on Day 1 in SAD cohorts and multiple doses BID from Day 1 to Day 14 (no second BID dose on Day 14) in MAD cohorts.
16078346|NCT02321384|Drug|RO6889678|RO6889678 will be administered orally as a single dose on Day 1 in SAD cohorts and multiple doses BID from Day 1 to Day 14 (no second BID dose on Day 14) in MAD cohorts.
16078347|NCT02321384|Drug|Midazolam|Single dose of 100 mcg midazolam solution will be administered orally, before (Day -1) and after (Day 14) the treatment with RO6889678 or matching placebo.
16078348|NCT02321384|Drug|Ritonavir|RTV will be administered orally as a single dose on Day 1 in RTV-boosted SAD cohorts and multiple doses BID from Day 1 to Day 14 (no second BID dose on Day 14) in RTV-boosted MAD cohorts.
16078349|NCT02321371|Drug|Lactulose + Rifaximin|Lactulose + addition of Rifaximin 400 mg 8th hourly through enteral route
16078350|NCT02321371|Drug|Lactulose|Continuation of Lactulose therapy for further 48 hours.
16078351|NCT02321358|Behavioral|Two-time implementation intention|Will be given intervention and booster at six weeks
16078352|NCT02321358|Behavioral|One-time implementation intention|Will only be given the intervention once
16078353|NCT02321358|Behavioral|Sham Comparator|Canada's Food Guide for Healthy Eating will be provided. This contains a small amount of physical activity information.
16078354|NCT02321358|Behavioral|Physical Activity Materials|Thera-Bands, instructional DVD and exercise handout, instructional stretching handout, CSEP Physical activity guidelines.
16078355|NCT02321345|Other|Palliative Care Support|Palliative care meetings Quality of Life Assessments
16078356|NCT02321332|Procedure|bilateral simultaneous endoscopic thoracic symapthectomy|Patients underwent bilateral simultaneous T2-T3 ganglionectomy using thoracoscopic approach.
16078357|NCT02321332|Procedure|unilateral sequential endoscopic thoracic symapthectomy.|Patients underwent unilateral T2-T3 ganglionectomy of the dominant side followed by T2-T3 ganglionectomy of the other side after 2 months interval.
16078358|NCT02321319|Drug|Hydromorphone HCl ER Tablets|Hydromorphone hydrochloride (HCl) extended release tablet
16078359|NCT02321306|Drug|LUM001|LUM001 administered orally once each day.
16078360|NCT02321293|Dietary Supplement|CurcuVIVA™|80 mg PO daily for 8 weeks with an option to reduce the dose based on individual tolerability
16078361|NCT02321293|Drug|Tyrosine Kinase Inhibitor gefitinib (Iressa)|250 mg PO daily until progression
16078362|NCT02321293|Drug|Tyrosine Kinase Inhibitor erlotinib (Tarceva)|150 mg PO daily until progression
16078363|NCT02321280|Drug|Denosumab|Single dose subcutaneous administration
16078364|NCT02321267|Drug|ranibizumab, aflibercept, pegaptanib, verteporphin|ranibizumab, intravitreal injections, 0.5mg, monthly or less aflibercept,intravitreal injections, 2.0mg, monthly or less pegaptanib, intravitreal injections, 0.3mg, every 6-week pars plana vitrectomy, once verteporphin, iv, 6mg/㎡
16078365|NCT02321254|Device|The RehaARM-Robot|Robot therapy by using a 3-Degrees-Of-Freedom (3DOFs) robot to train the shoulder.
16078366|NCT02321254|Behavioral|Standard rehabilitation therapy|Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities.
16078367|NCT02321241|Drug|Aflibercept (EYLEA, BAY-86-5321)|"st year: 3 monthly injections followed by 1 injection every two months
~nd year and following: injection according the visual and anatomical results observed the 1st year"
16078368|NCT02321228|Procedure|Salpingectomy with delayed oophorectomy|Early salpingectomy upon completions of childbearing with postponement of oophorectomy until between 40 and 45 in BRCA1 mutation carriers and between age 45 and 50 in BRCA2 mutation carriers.
16078369|NCT02321228|Procedure|Risk-reducing salpingo-oophorectomy|This is the current guideline procedure, usually performed between age 35 and 40 in BRCA1 mutation carriers and between age 40 and 45 in BRCA2 mutation carriers.
16078370|NCT02321215|Other|Introductory Disease Education|This intervention will consist of two one-on-one education sessions, each lasting 30 minutes.
16078763|NCT02318329|Drug|FPA144|FPA144 will be administered by IV infusion over approximately 30 minutes every 2 weeks.
16078371|NCT02321202|Drug|Omega-3 Fatty Acid-Based Parenteral Nutrition|"Glucose, lipid emulsion, amino acids, fat-and water-soluble vitamins as well as electrolytes were compounded in an All-In-One manner. 20% Structolipid and 10% Omegaven (ω-3 fatty acid [FA] mainly; Fresenius-Kabi, Germany) were applied to the trial group, but only Structolipid (ω-6 FA mainly) to the control group for 5 consecutive days postoperatively."
16078372|NCT02321202|Drug|Structolipid|"Glucose, lipid emulsion, amino acids, fat-and water-soluble vitamins as well as electrolytes were compounded in an All-In-One manner. 20% Structolipid and 10% Omegaven (ω-3 FA mainly; Fresenius-Kabi, Germany) were applied to the trial group, but only Structolipid (ω-6 FA mainly) to the control group for 5 consecutive days postoperatively."
16078373|NCT02321189|Drug|LONGEVINEX|let everyone of the participants oral 1 capsule containing 100 mg LONGEVINEX
16078374|NCT02321189|Drug|placebo|let everyone of the participants oral 1 capsule containing 100 mg placebo
16078375|NCT02321176|Drug|trans-resveratrol|"patients received 100mg Longevinex everyday,total of three days
~1 capsule daily for one day containing 100 mg of trans resveratrol active ingredient"
16078376|NCT02321163|Device|NMES new paradigm|stimulation frequency: 2 Hz; intensity: low amplitude; duration: 3 hours, 2 times per day for 8 weeks
16078377|NCT02321163|Device|NMES conventional|stimulation frequency: 50 Hz; intensity: maximally tolerated; duration: 30 min per day for 8 weeks
16078378|NCT02321163|Device|NMES no stimulation|Placebo, electrode pad on, no stimulation
16078379|NCT02321150|Procedure|Cautery|"Pterygium dissected off, corneal bed burred smooth and autograft harvested as per usual technique.
~Conjunctiva undermined at the recipient site.
~Relaxing incisions placed at the corners of the recipient site.
~Graft is slid into place
~Graft / host interface is gently dried with a Qtip
~Bipolar cautery is applied after grasping the graft and host conjunctiva gently between cautery forceps.
~Power setting: 25.
~Duration of cautery: 4 -5 seconds; the tissue should whiten and contract as desiccation and coagulation take place. Some charring may occur.
~Counter traction is applied to the conjunctiva as the cautery forceps are gently teased off
~Cautery is applied at the 4 apices of the graft then in between these points."
16078380|NCT02321150|Procedure|Sutures|"Pterygium dissected off, corneal bed burred smooth and autograft harvested as per usual technique.
~Conjunctiva undermined at the recipient site.
~Graft is slid into place The graft is secured to host conjunctiva using 7 interrupted sutures"
16078381|NCT02321137|Procedure|Surgical closure of left atrial appendage|aortic valve replacement with bioprosthesis according to indications in the current guidelines for the management of valvular heart disease. The operation as well as the pre and post-operative care will be performed according to local surgical policies.
16078382|NCT02321137|Procedure|No closure of left atrial appendage|aortic valve replacement with bioprosthesis according to indications in the current guidelines for the management of valvular heart disease.
16078383|NCT02321124|Other|connective tissue manipulation|We will apply connective tissue manipulation 5 days a week for four weeks.
16078384|NCT02321124|Behavioral|life style advice|We will apply life style advice for four weeks.
16078385|NCT02321111|Drug|Eritoran|Eritoran = E5564 Eritoran is a pharmacologic inhibitor of TLR4.
16078386|NCT02321111|Drug|D5W (5% Dextrose in water)|D5W = 5% Dextrose Water Vehicle
16078387|NCT02321098|Drug|Loceryl NL + Cosmetic varnish|Loceryl NL + Cosmetic varnish once/week for 12 weeks
16078388|NCT02321098|Drug|Loceryl NL 12 weeks|Loceryl NL once/week for 12 weeks
16078389|NCT02321098|Drug|Loceryl NL 15 months|Loceryl once/week for additional 15 months
16078390|NCT02321085|Procedure|Sinus Rhythm control|
16078391|NCT02321085|Procedure|Pulse Rate control|
16078392|NCT02321072|Drug|Oxygen|
16078393|NCT02321059|Device|Measurement of abdominal wall strength|Test-retest examination of the reliability of the Goodstrength trunk dynamometer
16078394|NCT02321033|Dietary Supplement|soft drinks|soft drinks with palatinose and maltodextrin
16078395|NCT02321020|Procedure|Radiofrequency maze procedure|Radiofrequency energy was used to create continous endocardial and epicardial lesions mimicking most of the left atrial incisions set as described in the Cox Maze III procedure. In the first 70 patients a monopolar technology was employed (Cardioblate Surgical Ablation Pen, Medtronic Inc, Minneapolis, MN, USA - cooled tip cardioblate pen, power ranging from 25 to 35 W), while in the subset of patients who underwent surgery after July 2005 a bipolar device was used (Cardioblate BP2 Irrigated RF Surgical Ablation System, Medtronic Inc, Minneapolis, MN, USA). The tip of both types of RF probe was irrigated with saline at room temperature at a flow rate of 4-6 ml/min.
16078396|NCT02321020|Procedure|Transthoracic echocardiography|Contemporary to clinical follow up, all patients were evaluated with 2-dimensional transthoracic echocardiography by the same cardiologist at 3,6,12 and 24 months in order to specifically monitor left atrial contractility presence.
16078397|NCT02320981|Diagnostic Test|Standard of Care esophagogastroduodenoscopy (EGD) with measurement of mucosal impedance|
16078398|NCT02320968|Other|MedclineTM Sleep Assist Pillow|The pillow is designed so that the sleeper can have proper upper-body elevation while sleeping on his or her left side without the need for placing blocks under the head of the bed and bothering anyone else who may be sleeping in the bed. The pillow supports the patient's head, back and body to provide comfort while reducing or relieving acid reflux symptoms during sleep.
16078399|NCT02320955|Procedure|Reimplantation of cryoconserved bone flap|A bone flap, which was explanted for decompression of a swollen brain or following severe head trauma and which was cryoconserved in the meantime is reimplanted. This procedure is the gold-standard therapy after decompressive hemicraniectomy and is routinely performed.
16078400|NCT02320942|Other|Exercise Intervention|The semi-supervised intervention is a progressive program with a goal of three aerobic and two resistance exercise sessions per week. Aerobic exercise will consist of 20-40 minutes of bicycling using a stationary bike located on CP6 (supervised or un-supervised) or brisk walking at home. Resistance exercise will include exercise for the upper and lower extremities with stretch bands. Patients will complete at least one supervised aerobic and resistance session per week with the exercise trainer and complete a daily log of their exercise, including adherence, adverse events and symptoms.
16078401|NCT02320929|Procedure|Intraoperative flexor tendon sheath irrigation|
16078402|NCT02320929|Procedure|Postoperative flexor tendon sheath irrigation|
16078403|NCT02320916|Procedure|23Gauge|Arterial puncture will be made using a 23Gauge needle
16078404|NCT02320916|Procedure|25Gauge|Arterial puncture will be made using a 25Gauge needle
16078405|NCT02320903|Device|VillageWhere App|
16078406|NCT02320890|Device|YBand (YDT-201N)|transcranial Direct Current Stimulation (tDCS) 2mA for 30 min; 20 sec of ramp-up and -down; left(anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)
16078407|NCT02320890|Device|sham-YBand (YDT-201N)|transcranial Direct Current Stimulation (tDCS) 2mA for 20 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)
16078408|NCT02320877|Device|Mandibular Advancement Device (Somnomed Flex)|The SomnoDent Flex™ MAS is a custom-made, titratable MAS that is validated in randomized controlled trials described in literature
16078409|NCT02320864|Procedure|Total knee replacement surgery|The surgeon removes damaged cartilage and bone from the surface of the knee joint and replaces them with a man-made surface of metal and plastic.
16078410|NCT02320851|Behavioral|SVD-tailored Integrative Psychotherapy (IPT)|(see description of corresponding study arm)
16078411|NCT02320851|Behavioral|Self-help group (SHG)|(see description of corresponding study arm)
16078412|NCT02320838|Device|5 KHz|5 KHz transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
16078413|NCT02320838|Device|TENS|TENS transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
16078414|NCT02320838|Device|Sham stimulation|Sham transcutaneous electrical stimulation over superficial radial nerve through the electrotherapy device Myomed 932. (Enraf-Nonius, Delft, Netherlands)
16078415|NCT02320825|Radiation|single-fraction SRS|
16078416|NCT02320825|Radiation|high-dose hypofractionated SRS|
16078417|NCT02320825|Behavioral|Quality of Life Measures|
16078418|NCT02320812|Biological|human retinal progenitor cells|single intravitreal injection of 0.5 - 3.0 million human retinal progenitor cells (hRPC)
16078419|NCT02320799|Behavioral|interpersonal psychotherapy|Interpersonal psychotherapy is an evidence based, structured, brief psychotherapy which improves relationships in order to improve mood and reduce anxiety
16078420|NCT02320799|Behavioral|treatment as usual|Clinic psychosocial treatment as usual
16078421|NCT02320786|Behavioral|CoPILOT|Participants in both groups will receive twelve hours of training in a standard powered wheelchair however the CoPILOT groups will use remote control technology we have developed. The technology provides the trainer with remote control of wheelchair speed and direction allowing the trainer to override the participant's actions as needed to ensure safe error-free shared controlled wheelchair training. The CoPILOT approach will accommodate varied learning needs, as per adult learning principles, while decreasing trainer input until the participant can complete tasks independently.
16078422|NCT02320773|Drug|Betmiga®|Oral
16078423|NCT02320760|Behavioral|Physical activity on prescription|
16078424|NCT02320747|Other|Tai Chi|
16078425|NCT02320734|Drug|Rocuronium|Rocuronium given continuously to reach deep neuromuscular block
16078426|NCT02320721|Drug|Insulin Glargine (HOE901 - U300)|Self-administered by subcutaneous (SC) injection in the evening using a pre-filled pen. Dose titration to achieve fasting self-monitored plasma glucose (SMPG) from 90 to 130 mg/dL (5.0 to 7.2 mmol/L).
16078427|NCT02320721|Drug|Insulin Glargine (HOE901 - U100)|Self-administered by SC injection in the evening using a pre-filled pen. Dose titration to achieve fasting SMPG from 90 to 130 mg/dL (5.0 to 7.2 mmol/L).
16078428|NCT02320721|Drug|Background therapy|Non-insulin anti-diabetic drugs with the exception of thiazolidinediones.
16078429|NCT02320708|Drug|Acetaminophen (ACE) (1000 mg)|2 Test ACE 500 mg tablets taken orally one time
16078430|NCT02320708|Drug|Commercial ACE (1000 mg)|2 ACE 500 mg caplets taken orally one time
16078431|NCT02320708|Drug|Commercial Ibuprofen (IBU) (400 mg)|2 IBU 200 mg soft-gels taken orally one time
16078432|NCT02320708|Drug|Placebo|2 placebo caplets for acetaminophen taken orally one time
16078433|NCT02320708|Drug|Placebo|2 placebo soft-gels for ibuprofen taken orally one time
16078434|NCT02320708|Drug|Placebo|2 placebo tablets for Test acetaminophen taken orally one time
16078435|NCT02320695|Drug|Saline|
16078436|NCT02320695|Drug|Isopropyl Alcohol|
16078437|NCT02320695|Drug|Pain Relieving Cream|
16078438|NCT02320695|Drug|Antibiotic/Pain Relieving Ointment|
16078439|NCT02320695|Drug|Original Ointment|
16078440|NCT02320695|Drug|Pain Relief Ointment|
16078441|NCT02320682|Device|Surgery for Total Hip Arthroplasty (THA)|THA surgery where four prosthetic components will randomly be inserted. Randomly an Exeter or SP-CL femur component will be combined with randomly a Delta TT or Delta PF acetabular component.
16078442|NCT02320669|Drug|Triostat|Bolus of Triiodothyronine followed by infusion for 48 hours
16078443|NCT02320669|Drug|Placebo|Bolus of Placebo followed by infusion for 48 hours
16078444|NCT02320656|Other|Blood sampling|Longitudinal (3 stages of the disease)
16078445|NCT02320656|Other|Bone marrow aspirate|Longitudinal (3 stages of the disease)
16078446|NCT02320656|Other|Skin biopsy|Single biopsy (optional)
16078447|NCT02320656|Other|Buccal swab|Single sampling.
16078448|NCT02320643|Device|Seratom® PA mesh|Partially absorbable mesh
16078449|NCT02320630|Drug|Entanercept|Both Entanercept and MTX were given to patients for 60weeks (Week0-Week60).
16078450|NCT02320630|Drug|HCQ|Combination of HCQ+SSZ+MTX were given to patients for 60weeks (Week0-Week60).Entanercept was given to patients for 12 weeks (Week0-Week12).
16078451|NCT02320630|Drug|MTX|MTX was given to patients for 60weeks (Week0-Week60). Entanercept was given to patients for 12 weeks (Week0-Week12).
16078452|NCT02320617|Procedure|Diffusion Magnetic Resonance Imaging|Diffusion weighted imaging (DWI) is a form of magnetic resonance imaging based upon measuring the random Brownian motion of water molecules within a voxel of tissue. The relationship between histology and diffusion is complex, however generally densely cellular tissues or those with cellular swelling exhibit lower diffusion coefficients, and thus diffusion is particularly useful in tumour characterisation
16078453|NCT02320604|Drug|Administration of study drug|i.v. administration of Ambisome in two different dossages
16078454|NCT02320591|Other|care management fee|for each Medicare beneficiary attributed to the practice, the practice received a monthly care management fee
16078532|NCT02319967|Behavioral|CAPE|Decision support and communication tool to promote guideline-recommended care by providers and use of such care by children/caregivers
16078455|NCT02320591|Other|feedback reports|Each participating practice received quarterly reports showing the practice's trend in key outcomes during the pre-intervention and intervention periods. The risk adjusted average Medicare expenditures of their patients were also shown in relation to all of the other CPC practices in their region, and to those with a similar average risk profile. Unadjusted hospitalization rates and emergency room visits were also plotted over time and compared to those of other CPC practices in the region
16078456|NCT02320591|Other|technical assistance|CPC practices could ask for technical assistance on transformation activities from a regional learning faculty (RLF). The RLF also provided seminars and other learning activities, as well as provided a forum for participating practices to share lessons they had learned.
16078457|NCT02320578|Procedure|3D Laparoscopy|3D Laparoscopy approach
16078458|NCT02320578|Procedure|Standard Laparoscopy|Standard laparoscopy approach
16078459|NCT02320565|Procedure|3D Laparoscopy|3D Laparoscopy approach
16078460|NCT02320565|Procedure|Standard Laparoscopy|Standard laparoscopy approach
16078461|NCT02320552|Other|No intervention|no intervention
16078462|NCT02320526|Behavioral|Control|
16078463|NCT02320526|Behavioral|Continuous walking|
16078464|NCT02320526|Behavioral|Interval walking|
16078465|NCT02320513|Other|Wearing activty monitoring device (Fitbit Flex)|
16078466|NCT02320513|Device|Fitbit Flex|
16078467|NCT02320500|Behavioral|Standard Physiotherapy|standard of care physiotherapy once every 2 weeks for 8 weeks
16078468|NCT02320500|Other|Myofascial-specific therapy|Once every 2 weeks for 8 weeks (includes trigger point injections if deemed 'necessary' by chronic pain physician)
16078469|NCT02320487|Drug|Bendamustine|Bendamustine was administered as an intravenous infusion at a dose of 90 milligrams per square meter (mg/m^2) on Days 2 and 3 Cycle 1; and on Days 1 and 2 Cycles 2-6.
16078470|NCT02320487|Drug|Obinutuzumab|Obinutuzumab was administered as an intravenous infusion at a dose of 100 milligrams (mg) on Day 1 Cycle 1; at a dose of 900 mg on Day 2 Cycle 1; at a dose of 1000 mg on Days 8 and 15 Cycle 1, and Day 1 Cycles 2-6.
16078471|NCT02320474|Drug|Aflibercept|
16078472|NCT02320448|Drug|PIPAC|
16078473|NCT02320435|Drug|Pertuzumab|In general, patients will continue to receive 420 milligrams (mg) of pertuzumab administered as an intravenous infusion every 3 weeks following the guidance of the Parent protocol.
16078474|NCT02320435|Drug|Trastuzumab|If trastuzumab intravenous infusions were given in combination with pertuzumab as part of the Parent study, patients will continue to receive treatment at the same dose, schedule and under the same administration guidelines which were in effect at the time of Parent study closure.
16078475|NCT02320435|Drug|Other Combination Anti-Cancer Therapies|If other anti-cancer therapies were given in combination with pertuzumab as part of the Parent study, patients will receive all treatments at the same dose, schedule and under the same administration guidelines which were in effect at the time of Parent study closure.
16078476|NCT02320422|Behavioral|Behavioral Telehealth|The telemetric intervention (administered via telephone, or interactive video chat applications such as FaceTime ® or Skype ®) will enable the intervention team (IT) to address non-adherence from a remote location, using a structured, tailored approach
16078477|NCT02320409|Drug|Sulfatinib|250mg Sulfatinib ,single dose,oral
16078478|NCT02320396|Drug|Desloratadine 5 mg|Desloratadine 5 mg tablets
16078479|NCT02320396|Drug|Placebo|Placebo tablets
16078480|NCT02320383|Biological|GA101 (Obinutuzumab)|"Induction
~Cycle 1: d1 - 100 mg, (d1 or) d2 - 900 mg, d8+15 - 1000 mg i.v., q28d
~Cycle 2 - 6: d1 - 1000 mg i.v., q28d
~Maintenance
~GA101 iv 1000 mg (flat dose): every 84 days"
16078481|NCT02320383|Drug|Bendamustine|"Induction
~Cycle 1: d3+4 (or d2+3) - 70 mg/m² i.v., q28d
~Cycle 2 - 6: d2+3 - 70 mg/m i.v., q28d"
16078482|NCT02320370|Device|NeuroConn DC Stimulator Plus tDCS|transcranial electrical stimulation intervention with two experimental protocols
16078483|NCT02320357|Drug|Treatment by clopidogrel|Peripheral blood will be obtained during the study
16078484|NCT02320344|Behavioral|Partners in Care|"The diabetes self-management intervention is titled, Partners in Care, emphasizing that there are many individuals and groups that one can call upon to assist with managing one's diabetes. The content includes practical behavioral strategies to improve diabetes self-management practices. The 12 week curriculum provides a basic overview of diabetes and self-management activities, standards of care recommended by the American Diabetes Association, strategies to improve patient-provider communication, support needed for diabetes self-management, information about diabetes medications, and ways to avoid diabetes-related complications."
16078485|NCT02320331|Behavioral|PILI Lifestyle Program|A 12-week Individual-focused Behavioral Weight Loss Intervention. Our 12-week intervention is modeled after the Diabetes Prevention Program's (DPP) Lifestyle Intervention. Each of the 8 lessons of this 12-week intervention will be done in a group classroom setting via trained community peer educators for a total of 8 group meetings as outlined above. Lesson 1 through 4 will be done every week, once a week, for 4 weeks followed by every other week for the remaining 4 lessons (lessons 5 through 8). Each group meeting will have between 12 to 15 people and take 1 to 1 ½ hours to complete. After completing the 12-week behavioral weight loss intervention, participants will participate in an additional 6 lessons. A lesson will be done once-a-month. These 6 lessons will teach participants how to involve their family and friends in their healthy lifestyle changes.
16078486|NCT02320318|Drug|Ibodutant 10 mg|Oral tablet, once daily.
16078487|NCT02320318|Drug|Placebo|Oral tablet (identical in appearance and weight to ibodutant tablet), once daily.
16078488|NCT02320305|Biological|MART-1 Antigen|Given IM
16078489|NCT02320305|Drug|TLR4 Agonist GLA-SE|Given IM
16078490|NCT02320305|Other|Laboratory Biomarker Analysis|Correlative studies
16078491|NCT02320292|Other|Quality-of-Life Assessment|Ancillary studies
16078492|NCT02320292|Biological|Rituximab|Given IV
16078493|NCT02320292|Radiation|Yttrium Y-90 Ibritumomab Tiuxetan|Given IV
16078494|NCT02320279|Device|Fetal Heart Rate Monitor|Use of a system that monitors fetal heart rate through use of fetal EKG read using abdominal electrodes
16078531|NCT02319980|Procedure|Extracranial-intracranial bypass surgery|All participants in this group will undergo combined cerebral revascularization surgery,namely superficial temporal to middle cerebral artery bypass (STA-MCA) and encephalo-duro-myo-synangiosis(EDMS)
16078654|NCT02319135|Drug|Fludarabine|
16078655|NCT02319135|Drug|Cytarabine|
16078495|NCT02320253|Behavioral|In Person Group (IP)|The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via in-person groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success.
16078496|NCT02320253|Behavioral|Telephone Conference Call Group (TCC)|The goals of the diabetes lifestyle intervention program are weight loss of 5-10% of initial body weight and increased activity levels to 175 minutes/week of moderate intensity physical activity. Dietitians will deliver the adapted Look AHEAD lifestyle intervention via telephone conference call groups combined with 2-3 individual sessions per year. The program curriculum focuses on nutrition, activity, and behavioral topics and incorporates the use of meal replacements for the first 4-16 weeks to enhance weight loss success. Dietitians will deliver the adapted Look AHEAD lifestyle intervention.
16078497|NCT02320253|Behavioral|Medical Nutrition Therapy (MNT)|Participants are referred to meet with a registered dietitian for individual medical nutrition therapy sessions up to 3-4 times per year.
16078498|NCT02320240|Drug|Duloxetine|Current exposure to Duloxetine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.
16078499|NCT02320240|Drug|Venlafaxine|Current exposure to Venlafaxine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.
16078500|NCT02320240|Drug|Desvenlafaxine|Current exposure to Desvenlafaxine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.
16078501|NCT02320240|Drug|Citalopram|Current exposure to Citalopram will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.
16078502|NCT02320240|Drug|Escitalopram|Current exposure to Escitalopram will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.
16078503|NCT02320240|Drug|Fluoxetine|Current exposure to Fluoxetine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.
16078504|NCT02320240|Drug|Fluvoxamine|Current exposure to Fluvoxamine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.
16078505|NCT02320240|Drug|Paroxetine|Current exposure to Paroxetine will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.
16078506|NCT02320240|Drug|Sertraline|Current exposure to Sertraline will be defined as a prescription lasting until the index date or dispensed in the 60 days before the index date.
16078507|NCT02320227|Device|Miami w/o frag Personal lubricant|
16078508|NCT02320214|Device|Miami w/ frag Personal lubricant|
16078509|NCT02320201|Device|Transcutaneous Electrical Nerve Stimulator (TENS)|Electrical stimulation will be applied to the foot via skin surface electrodes for a minimum of 2 hours per day for 1 week to 20 subjects.
16078510|NCT02320188|Other|Eccentric exercise|This study aimed to determine the muscle effects of ECC training, with the primary outcome being the knee extensor strength gain at 3 months.
16078511|NCT02320188|Other|Concentric exercise|The purpose of the study is to determine in a randomized controlled trial (RCT), the efficacy of eccentric exercise training in restoring muscle mass and function in patients with rheumatoid cachexia.
16078512|NCT02320175|Behavioral|Patient and Family Centered I-PASS|Patient and Family-Centered I-PASS is a bundle of communication interventions to improve the quality of information exchange between physicians, nurses, and families, and to better integrate families into all aspects of daily decision making in hospitals. The intervention included a health literacy-informed, structured communication framework for family-centered rounds; written rounds summaries for families; a training and learning program; and strategies to support teamwork and implementation.
16078513|NCT02320162|Behavioral|Experiential learning oral health education|
16078514|NCT02320149|Drug|Sarecycline|1.5 mg/kg/day taken orally at the same time each day,
16078515|NCT02320149|Drug|Placebo|Placebo-matching sarecycline tablets taken orally at the same time each day.
16078516|NCT02320136|Behavioral|cognitive testing|patients perform simple tasks like watching a video or memorizing items
16078517|NCT02320123|Behavioral|Educational DVD|African American patients and their primary non-professional caregivers will watch a DVD created to introduce end-of-life care planning to African Americans receiving palliative care.
16078518|NCT02320097|Other|Foot pressure measurement|"Description of the foot pressure measurement:
~The subject stands on the platform, with the heels and buttocks touching a vertical plane and the head held freely. The subject then moves his/her head backwards so that it touches the vertical plane. Next, he/she turns the head to the right and then towards the left. Each of these positions is maintained for 2 minutes.
~The platform's sensors measure the anteroposterior foot pressure distribution during the various acquisitions."
16078519|NCT02320084|Drug|Nitisinone|Nitisinone according to prescription
16078520|NCT02320071|Other|Examination of abdominal wall strength changes over time|
16078521|NCT02320058|Drug|Ipilimumab|
16078522|NCT02320058|Drug|Nivolumab|
16078523|NCT02320045|Drug|ITCA 650 (Exenatide in osmotic mini pump)|
16078524|NCT02320032|Drug|Aripiprazole Lauroxil|Gluteal IM injection, given once every 4 to 8 weeks
16078525|NCT02320019|Drug|Placebo|Placebo matching YH14618
16078526|NCT02320019|Drug|YH14618|
16078527|NCT02320006|Other|acupuncture|For RN4、CV6 CV3 and EX-CA1, needles will be inserted vertically to the abdominal muscles. The acupuncturist can feel resistance from the tip of the needle when touching the muscles and continues to insert it to a depth of 2-3 mm and stops. For ST36 and SP6, needles will be inserted vertically to a depth of 25 mm. The needles will be manipulated with an even lifting and twisting method three times to achieve the sensation of deqi.
16078528|NCT02319993|Drug|TIAN WANG BU XIN DAN|assigned to TWBXD (n =48) and were instructed to take 6 gm 2 times per day of TWBXD for a period of 4 weeks.
16078529|NCT02319993|Drug|Suan Tzao Ren Tang|assigned to SZRT (n = 48) and were instructed to take 6 gm 2 times per day of SZRT for a period of 4 weeks.
16078530|NCT02319993|Drug|Placebo|1/10 TIAN WANG BU XIN DAN assigned to placebo (n =32) and were instructed to take 6 gm 2 times per day of placebo for a period of 4 weeks.
16078656|NCT02319135|Drug|Lenograstim|
16078533|NCT02319967|Behavioral|CHW home visits|Home visits by community health workers (CHW) to assist children and their caregivers to implement the CAPE and other guideline-recommended competencies.
16078534|NCT02319954|Procedure|Direct compression|Direct compression by the surgeon with their hands on the nasal sidewall
16078535|NCT02319941|Drug|ticagrelor|
16078536|NCT02319941|Drug|clopidogrel|
16078537|NCT02319928|Procedure|Colonoscopy|
16078538|NCT02319915|Drug|Tranexamic Acid|
16078539|NCT02319915|Drug|Adrenalin|
16078540|NCT02319902|Device|Standard cold carbon dioxide gas|Use of standard cold carbon dioxide gas in laparoscopic gynaecological surgery.
16078541|NCT02319902|Device|Heated humidified carbon dioxide gas|Use of the Fischer and Paykel heated humidification system for laparoscopic gynaecological surgery.
16078542|NCT02319889|Radiation|Stereotactic Body Radiotherapy|Undergo SBRT
16078543|NCT02319889|Drug|Carboplatin|Given IV
16078544|NCT02319889|Drug|Paclitaxel Albumin-Stabilized Nanoparticle Formulation|Given IV
16078545|NCT02319863|Procedure|hepatectomy (conventional method)|A Simple Technique of Rapid Ligating the Corresponding Inflow and Outflow Vessels Without Hilus Dissection During Hepatectomy
16078546|NCT02319863|Procedure|hepatectomy (rapid ligating)|
16078547|NCT02319850|Radiation|DXA scanning|Exposure: Participants will undergo DXA scanning in the supine position per manufacturer guidelines to estimate absolute and percentage of total lean body mass (LBM) and body fat (BF).
16078548|NCT02319837|Drug|Enzalutamide|
16078549|NCT02319837|Drug|Placebo|Sugar pill to mimic enzalutamide
16078550|NCT02319837|Drug|Leuprolide|
16078551|NCT02319824|Biological|Autologous NY-ESO-1-specific CD8-positive T Lymphocytes|Given IV
16078552|NCT02319824|Other|Laboratory Biomarker Analysis|Correlative studies
16078553|NCT02319824|Radiation|Palliative Radiation Therapy|Undergo palliative radiation therapy
16078554|NCT02319811|Procedure|Cryopreserved meniscus transplants|Lateral or medial cryopreserved meniscus transplants implanted into appropriately indicated patients.
16078555|NCT02319798|Other|telephone consultations|Those randomized to telephone consultation will be told to expect a call from the gastroenterology doctor at the time of their appointment.
16078556|NCT02319798|Other|face-to-face consultations|Those randomized to face-to-face follow up will attend their appointments in hospital
16078557|NCT02319785|Behavioral|RAT-NMES|This combined RAT- treatment involves the same protocol as the RAT regimen except that patients receive neuromuscular electrical stimulation (NMES) concurrently with RAT.
16078558|NCT02319785|Behavioral|RAT-MT|This combined RAT- treatment involves the same protocol as the RAT regimen except that patients receive mirror therapy instead of functional activities training after RAT.
16078559|NCT02319785|Behavioral|Mirror therapy|This protocol includes mirror therapy and functional training in a session. The treatment intensity is 1.5 hours/day, 5 days/week, for 4 weeks. MT focuses on symmetrical bimanual movements and simultaneously observing the mirror visual feedback reflected by the unaffected upper extremity.
16078560|NCT02319785|Behavioral|Unilateral RAT|"This protocol includes warm-up, unilateral RAT, and functional activities training. The treatment intensity is 1.5 hours/day, 5days/week for 4 consecutive weeks.
~The unilateral RAT session uses the robot-assisted arm trainer, InMotion Isokinetic Testing and Evaluation System."
16078561|NCT02319785|Behavioral|Bilateral RAT|"This protocol includes warm-up, bilateral RAT, and functional activities training. The treatment intensity is 1.5 hours/day, 5days/week for 4 consecutive weeks.
~The unilateral RAT session uses the robot-assisted arm trainer, Bi-Manu-Track (Reha-Stim Co., Berlin, Germany)."
16078562|NCT02319785|Behavioral|Conventional rehabilitation|Participants in this group receive a structured protocol based on occupational therapy such as neuro-developmental techniques and task-oriented approach. The treatment dose is matched to RAT and MT groups.
16078563|NCT02319772|Drug|BCX4430|
16078564|NCT02319772|Drug|Placebo|
16078565|NCT02319759|Drug|Guselkumab|In the guselkumab group, Guselkumab 100 mg subcutaneous injection will be administered at Weeks 0, 4, 12, 20, 28, 36 and 44. In the placebo group, guselkumab 100 mg subcutaneous injection will be administered at Weeks 24, 28, 36 and 44 for participants remaining on placebo at Week 24.
16078566|NCT02319759|Drug|Ustekinumab|In both placebo and guselkumab groups, if the participants qualify for early escape, they will switch to receive ustekinumab 45 mg or 90 mg subcutaneous injection at Weeks 16, 20, 32, and 44 based on the approved dosage in the particular country of the study.
16078567|NCT02319759|Drug|Placebo|In placebo group, Placebo subcutaneous injection will be administered at Weeks 0, 4, 12, and 20. In guselkumab group, placebo subcutaneous injection will be administered at Week 24 to maintain the blind.
16078568|NCT02319746|Behavioral|Cognitive-behavioral therapy program to first-episode psychosis patients and cannabis abuse|The intervention program is focused on reducing the cannabis use, improving awareness of illness, adherence to treatment, identification of prodromes, psychosocial functioning improvement and relapse prevention.
16078569|NCT02319746|Behavioral|Psychoeducation|The aim of psychoeducation is that the patient understands and be able to manage the disease providing the tools and skills to symptoms management, to avoid relapse and contribute to their wellbeing.
16078570|NCT02319733|Device|Bioresorbable vascular scaffold|Implantation of Bioresorbable vascular scaffold in vulnerable plaques
16078571|NCT02319720|Biological|Bone Marrow Aspirate|Fresh bone marrow aspirate administered to the wound at the time the bone marrow is taken.
16078572|NCT02319720|Biological|Cultured Bone Marrow Cells|The bone marrow aspirate will be sent to the laboratory to be grown in tissue culture. Once the cell cultures have matured (within 8 weeks) they will be checked for sterility and frozen until applied to the subject's wound.
16078573|NCT02319720|Procedure|Control|The subjects in this group will receive currently approved treatments for their wound. These treatments will include debridement and dressing changes. Wound dressings allowed will include gauze, foam dressings, occlusive films, and non-stick pads. More advanced dressing materials such as Hydrocolloids, alginates, silver containing dressings, and biomaterials can also be used. Compression will be utilized for lower extremity wounds.
16078657|NCT02319135|Drug|Filgastrim|
16078658|NCT02319122|Other|High Intensity Interval Training|See arm description
16078659|NCT02319122|Other|Progressive Resistance Training|See arm description
16078574|NCT02319707|Drug|Oxytocin|"The study group: divided into two groups:
~• Intramuscular treatment: pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IM Oxytocin during the third stage of labor.
~• Combined treatment: pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IM Oxytocin together with 10 IU of IV Oxytocin in 100 ml NaCl 0.9% during the third stage of labor."
16078575|NCT02319707|Drug|Oxytocin in 100 ml NaCl 0.9%|"The control group:
~pregnant women, 34-41 weeks of gestation, which were treated with 10 IU of IV Oxytocin in 100 ml NaCl 0.9% during the third stage of labor. (this is the routine practice in our department)."
16078576|NCT02319681|Behavioral|Simple Reminiscence (SR)|SR is a 30-minute psychoeducational activity administered by a trained RA at 4 home visits (week 2, week 3, week 7, and week 19). SR has a didactic component using the SR manual that the couple retains, viewing one of the brief video-vignettes illustrating the application of reminiscence techniques (a different video-vignette will be viewed at each visit), and facilitation of caregiver practice in applying the techniques, using a recent example of anxiety-linked experience of the person with EAD.
16078577|NCT02319681|Behavioral|Attention Control (AC)|AC is a 30-minute in which the person with EAD, the caregiver and the RA review and discuss the day's newspaper headlines. The RA will use communication techniques specifically designed to keep the conversation present focused at 4 home visits (week 2, week 3, week 7, and week 19).
16078578|NCT02319668|Drug|0.2% w/v Chlorhexidine digluconate|Participants will brush their teeth with the reference product (toothpaste) and thoroughly rinse their mouth with water and wait 5 timed minutes before using 10 ml of the 0.2% w/v Chlorhexidine digluconate mouthwash, except when using at site, where no brushing will take place prior to using the mouthrinse.
16078579|NCT02319668|Drug|Sodium fluoride toothpaste (Aquafresh Mild & Minty)|Participants will apply a strip of toothpaste to cover the head of the toothbrush and will brush in their usual manner for two timed minutes twice daily. They will then rinse their mouth thoroughly with water after brushing
16078580|NCT02319655|Procedure|Air tamponade|Air tamponade
16078581|NCT02319655|Procedure|Balanced salt solution filling|BSS filling
16078582|NCT02319642|Drug|Certolizumab Pegol|Active Substance: Certolizumab Pegol Pharmaceutical form: Prefilled syringes Concentration: 200 mg/ ml Route of Administration: Subcutaneous injection
16078583|NCT02319629|Drug|URSODIOL|preventive treatment with Ursolit to reduce the incidence of gallstones formation after bariatric surgery
16078584|NCT02319629|Drug|Placebo|
16078585|NCT02319616|Drug|Clobetasol 0.05% ointment|Blinded, daily application to one arm for a period of fourteen (14) days
16078586|NCT02319616|Drug|Placebo|Blinded, daily application to one arm for a period of fourteen (14) days
16078587|NCT02319603|Drug|Low dose WenXin keli|Low dose WenXin keli (the original quantity Wenxin keli): specification 10g /bag, Wenxin keli (no sugar) 5 g+ Wenxin keli simulation agent 5g.
16078588|NCT02319603|Drug|High dose WenXin keli|High dose WenXin keli(2 times the amount of Wenxin keli): specification 10g /bag, Wenxin keli (no sugar) 10 g.
16078589|NCT02319577|Drug|oral vinorelbine|Anti-neoplastic drug (PO chemotherapeutical agent, vinka alkaloid)
16078590|NCT02319577|Drug|Gefitinib|EGFR tyrosine kinase inhibitor
16078591|NCT02319564|Drug|Beclomethasone|
16078592|NCT02319564|Drug|Beclomethasone and Salbutamol|
16078593|NCT02319564|Drug|Placebo|
16078594|NCT02319564|Device|Aerochamber Max®|
16078595|NCT02319538|Procedure|Total thyroidectomy performed|Surgery combined with standard thyroxine treatment
16078596|NCT02319525|Other|Computerized patient decision-aid|The decision-aid contained information regarding lupus and lupus nephritis, its impact on patient lives and benefits and harms of lupus nephritis treatments, focused on immunosuppressive medications compared to each other. The content of the decision-aid allowed individualization based on patient preference for details on certain aspects, as well as the desire to view additional, optional sections of the decision-aid.
16078597|NCT02319525|Other|Usual care (lupus pamphlet)|Patient received the standard handout/pamphlet from a non-profit organization (American College of Rheumatology [ACR]) regarding lupus and its treatments, that explained risks and benefits of various treatments
16078598|NCT02319512|Other|Chewing gum|ChiczaTM organic chewing gum 6 pieces a day
16078599|NCT02319512|Other|Glucose|12ml glucose solution (13,6g) per day
16078600|NCT02319499|Dietary Supplement|Zinc Alone|Zn-alone group received 10 mg/day of elemental zinc (as zinc sulphate)
16078601|NCT02319499|Dietary Supplement|Iron and Zinc|Zn+Fe group received 10 mg/day of elemental zinc (as zinc sulphate) and 10 mg/day of elemental iron (as ferrous sulphate)
16078602|NCT02319499|Dietary Supplement|Iron, Zinc and Vitamin A|Zn+Fe+vit.A group received 10 mg/day of elemental zinc (as zinc sulphate) and 10 mg/day of elemental iron (as ferrous sulphate), plus 1,000 IU/day of vitamin A
16078603|NCT02319499|Other|Placebo|Placebo group received no minerals/vitamin
16078604|NCT02319486|Drug|carboplatin periocular injection|chemotherapy together with/without 20mg/2ml carboplatin periocular injection
16078605|NCT02319486|Drug|CEV chemotherapy|vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2
16078606|NCT02319473|Other|JAC Registry|patients who received acute reperfusion therapy
16078607|NCT02319460|Biological|Kcentra®|Kcentra®, Prothrombin Complex Concentrate (Human), is a blood coagulation factor replacement product that contains coagulation Factors II, VII, IX and X, and antithrombotic Proteins C and S as a lyophilized concentrate.
16078608|NCT02319460|Biological|Plasma|
16078609|NCT02319447|Behavioral|Additional education|"Our Intervention includes a 60-90 minute educational seminar, entitled Destination: Transplant, featuring live speakers, delivered to small groups of Black kidney transplant candidates and their family and friends. Topics include: 1) basic facts about Chronic Kidney Disease (CKD), transplant, and the waiting list; 2) the experience of receiving a LDKT transplant (by a Black LDKT recipient); 3) the experience of serving as a living kidney donor (by a Black living kidney donor); and 4) strategies to increase the chances of getting a transplant sooner. Participants receive monthly mailed, written information for 9 months and a follow-up phone call from a transplant educator, 3 months after attending the seminar."
16078610|NCT02319434|Device|Ostom-i Alert Sensor|Sensor on ostomy bag.
16078660|NCT02319096|Other|Whole body vibration therapy|Whole body vibration therapy using the Galileo machine as therapy for pelvic floor muscle training
16078661|NCT02319083|Procedure|Coronary artery bypass surgery|Patients will undergo coronary artery bypass grafting
16078611|NCT02319421|Other|Alarm Reduction Script|The intervention will consist of a script to facilitate the discussion of the alarm data that will take place on weekday mornings. The script will be used by huddle participants as a structured outline to rapidly discuss the high alarm low acuity patients eligible for intervention. The patients who are identified will have further discussion on rounds to determine if there are appropriate ways to reduce the alarm rates of individual patients through the safe adjustment of physiologic monitor parameters.
16078612|NCT02319408|Radiation|Preoperative radiation|Lobectomy for lung cancer following preoperative radiation
16078613|NCT02319395|Genetic|Blood Sampling and DNA collection|"One blood sampling during the study. A small number (1 to 5) of markers type tag SNPs or coding SNP  (single nucleotide polymorphism, SNP) will be selected for each of the selected genes, for a total of 50 markers (representing 20 to 25 genes). Non-silent coding SNP, that may have a functional effect, will be included as a priority. Genotyping is carried out by the method of genotyping VeraCode Goldengate."
16078614|NCT02319382|Radiation|PET with the tracer 18F-DPA-714|
16078615|NCT02319382|Radiation|PET with the tracer 11C-PE2I|
16078616|NCT02319382|Other|MRI|Magnetic field
16078617|NCT02319369|Drug|Milademetan|Milademetan will be administered daily as oral capsules or as a combination of multiple oral capsules containing 5 mg, 20 mg, 80 mg, and/or 200 mg
16078618|NCT02319369|Drug|AZA|AZA will be administered at 75 mg/m^2 subcutaneously or intravenously
16078619|NCT02319369|Drug|Milademetan|Milademetan will be administered daily as oral capsules or as a combination of multiple oral capsules containing 5, 20, 80, and/or 200 mg. An alternate combination of 30 mg, 80 mg, and/or 100 mg milademetan may be utilized.
16078620|NCT02319356|Dietary Supplement|Beetroot juice|(BRJ, containing NO3-, 6.2 mmol/day, administered as 500ml Beet it Sport Shots, James White drinks, Ipswich uk)
16078621|NCT02319356|Dietary Supplement|Placebo beetroot juice|(PL, NO3-depleted beetroot juice, administered as 500ml Placebo Beet it Sport Shots, James White drinks, Ipswich uk)
16078622|NCT02319343|Drug|Methylprednisolone|Comparison of preoperative single high dose of Methylprednisolone 125 mg iv. and isotonic Sodium Chloride (placebo)
16078623|NCT02319343|Drug|Isotonic Sodium Chloride|Placebo
16078624|NCT02319330|Behavioral|Nurse-delivered mobile phone counseling intervention|Multi-dimensional, patient-centered counseling approach used to build patient-provider rapport, establish sources of support, and enable and empower problem solving to address inter-related, multi-tiered barriers to care.
16078625|NCT02319330|Behavioral|Treatment as Usual|Routine HIV clinic-based counseling
16078626|NCT02319317|Behavioral|Risky driving prevention|The web-based intervention to prevent risky driving targets knowledge, attitudes, perceived control and norms about driver inattention, with strategies to keep attention on the roadway.
16078627|NCT02319317|Behavioral|Control group general health promotion|The control group will receive a web-based intervention for general health promotion and is designed to enhance participants' knowledge and ability to reduce their risk of adverse health conditions including, obesity and heart disease.
16078628|NCT02319304|Drug|FOLFOX {5-fluorouracil (5-FU), leucovorin, and oxaliplatin}|see arm description
16078629|NCT02319304|Radiation|Low dose fractionated radiation therapy (LDFRT)|see arm description
16078630|NCT02319291|Device|P.F.C. Sigma PS150 RP Total Knee System|Total Knee Arthroplasty - surgical procedure to replace knee with metal implant
16078631|NCT02319278|Drug|Ferumoxytol|Infusion following between paired MRI scans
16078632|NCT02319265|Drug|Melatonin|Oral liquid
16078633|NCT02319252|Device|Gastric tube (Nutricia Flocare® Pur Tube Enlock)|Nutricia Flocare® Pur Tube Enlock, Ch. 12
16078634|NCT02319252|Device|Jejunal tube (Nutricia Flocare® Bengmark®)|Nutricia Flocare® Bengmark®, Ch. 10
16078635|NCT02319239|Radiation|Fractionation|During a radiotherapy period the prostate movement will be monitored by temporary implanted electromagnetic detector. Rectum fixation at 15/39 fractions. DW-MRI at baseline, 3 months and 12 months.
16078636|NCT02319239|Radiation|hypofractionated|During a radiotherapy period the prostate movement will be monitored by temporary implanted electromagnetic detector. Rectum fixation at 10/20 fractions. DW-MRI at baseline, 3 months and 12 months
16078637|NCT02319239|Radiation|stereotactic fractionation|During a radiotherapy period the prostate movement will be monitored by temporary implanted electromagnetic detector. Rectum fixation at 5/5 fractions. DW-MRI at baseline, 3 months and 12 months
16078638|NCT02319226|Other|Transplantation from an HLA-identical sibling donor|The study will include a cohort of 60 patients transplanted from an HLA-identical sibling donor.
16078639|NCT02319213|Other|Intraocular pressure measurement with 9 mmHg insufflation|Comparison of intraocular pressure levels at different abdominal pressure
16078640|NCT02319213|Other|Intraocular pressure measurement with 12 mmHg insufflation|Comparison of intraocular pressure levels at different abdominal pressure
16078641|NCT02319213|Other|Intraocular pressure measurement with 15 mmHg insufflation|Comparison of intraocular pressure levels at different abdominal pressure
16078642|NCT02319200|Drug|Metformin|"1000 mg (2x500 mg) at morning and 1000 mg (2x500 mg) at afternoon (2000 mg per day)
~Metformin daily during 36 months"
16078643|NCT02319200|Drug|placebo tablet|4 tablets per day for 36 months
16078644|NCT02319187|Drug|S1|S1 80mg to 120 mg per day on Days 1-14, every 21 days
16078645|NCT02319187|Drug|S-1|S1 80mg to 120 mg per day on Days 1-10, every 14 days;
16078646|NCT02319187|Drug|irinotecan|irinotecan 160mg/m2 d1, every 14 days
16078647|NCT02319174|Device|Sphygmo|A team of engineers from Rice University has recently developed Sphygmo, an ambulatory, low-cost blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals
16078648|NCT02319161|Drug|Calcium channel blocker and beta blocker|The patients in which systolic blood pressure increased to 150 mmHg and above following tourniquet inflation and in which a bolus dose of calcium channel blocker 10 mg (Diltizem, Mustafa Nevzat İlaç Sanayi Aş) (Group I) or beta blocker 0.5mg/kg (Brevibloc, Eczacıbaşı İlaç Sanayi Aş) (Group II) were administered intravenously constituted the study groups.
16078649|NCT02319148|Drug|itraconazole|itraconazole dosed at 200 mg
16078650|NCT02319148|Drug|diltiazem|diltiazem dosed at 240 mg
16078651|NCT02319148|Drug|SR verapamil|SR verapamil dosed at 240 mg
16078652|NCT02319148|Drug|PF-00489791|PF-00489791 20 mg single dose administration
16078653|NCT02319135|Drug|Azacitadine|
16078662|NCT02319070|Other|Survey|Recombinant antihemophilic factor VIII (FVIII) on Secondary Prophylaxis treatment scheduled according to daily routine
16078663|NCT02319070|Other|Survey|Recombinant antihemophilic factor VIII (FVIII) On Demand treatment scheduled according to daily routine
16078664|NCT02319057|Drug|ORM-12741 MR A|Modified release formulation of ORM-12741
16078665|NCT02319057|Drug|ORM-12741 IR|Immediate release formulation of ORM-12741
16078666|NCT02319057|Drug|ORM-12741 MR B|Modified release formulation of ORM-12741
16078667|NCT02319044|Drug|MEDI4736|MEDI4736 monotherapy
16078668|NCT02319044|Drug|Tremelimumab|Tremelimumab monotherapy
16078669|NCT02319044|Drug|MEDI4736 + Tremelimumab|MEDI4736 + Tremelimumab combination therapy
16078670|NCT02319031|Drug|Daclatasvir|
16078671|NCT02319031|Drug|Sofosbuvir|
16078672|NCT02319031|Drug|Ribavirin|
16078673|NCT02319018|Drug|Alisertib|Given PO
16078674|NCT02319018|Drug|Fluorouracil|Given IV
16078675|NCT02319018|Other|Laboratory Biomarker Analysis|Correlative studies
16078676|NCT02319018|Drug|Leucovorin Calcium|Given IV
16078677|NCT02319018|Drug|Oxaliplatin|Given IV
16078678|NCT02319005|Drug|Revusiran (ALN-TTRSC)|
16078679|NCT02319005|Drug|Sterile Normal Saline (0.9% NaCl)|
16078680|NCT02318992|Biological|Fecal Microbiota|Fecal Microbiota will be delivered via colonoscopy.
16078681|NCT02318979|Device|Otto Bock prosthesis|Participants will run using the Otto Bock prosthesis at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.
16078682|NCT02318979|Device|Ossur prosthesis|Participants will run using the Ossur prosthesis at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.
16078683|NCT02318979|Device|Freedom Innovations prosthesis|Participants will run using the Freedom Innovations prosthesis at a recommended stiffness and height, one category stiffer than recommended at the recommended height, one category softter than recommended at the recommended height, at the optimal stiffness and 2 cm taller, and at the optimal stiffness and 2 cm shorter.
16078684|NCT02318966|Dietary Supplement|Medical Food - Glycosade|double blind randomised crossover of 2 starches - glycosade and UCCS
16078685|NCT02318953|Device|Mobile app follow-up care|The mobile app follow-up care is an application that can be loaded on to a smartphone. It allows the patient to submit photos of their surgical site, VAS pain scores, and QoR9 scores. The information collected is transmitted to members of the surgical team (i.e. the primary surgeon) and used to monitor recovery over the first 30-days following surgery.
16078686|NCT02318953|Other|Conventional, in-person follow-up care|This includes a typical in-person visit with the operating surgeon at one- and four-weeks after surgery.
16078687|NCT02318940|Device|central venous catheter|installation of Central venous catheter ultrasound guided
16078688|NCT02318940|Device|central venous catheter|installation of Central venous catheter landmark guided
16078689|NCT02318927|Device|Deep Brain Stimulation|Deep Brain Stimulation (DBS) of Globus Pallidum plus Pedunculopontine Nucleus, including lead implant and battery placement. Magnetic Resonance Imaging and Computed Tomography (CT) scan will be obtained prior to implant. Measurement of number of Freezing of Gait (FoG) episodes during a FoG test at a lab. Other measures include freezing of gait questionnaire, gait and falls questionnaire, activities/balance confidence scale, Parkinson's disease quality of life questionnaire, Unified Parkinson's Disease Rating Scale physiology collection and sensor testing, adverse event recording, falls diaries, tracking use of assistive devices, gait and balance testing, and neuropsychological, neurosurgical, neurological, and physical exams.
16078690|NCT02318914|Drug|gevokizumab|
16078691|NCT02318901|Drug|Pembrolizumab|
16078692|NCT02318901|Drug|Trastuzumab|
16078693|NCT02318901|Drug|ado-trastuzumab emtansine|
16078694|NCT02318901|Drug|Cetuximab|
16078695|NCT02318888|Procedure|Surgery|
16078696|NCT02318888|Drug|Icodextrin|
16078697|NCT02318875|Dietary Supplement|Kritech administration|300mg/day (1 capsule) during 12 weeks; oral ingestion
16078698|NCT02318875|Other|Placebo adminstration|1 placebo capsule per day during 12 weeks; oral ingestion
16078699|NCT02318862|Procedure|Standard of Care esophagogastroduodenoscopy (EGD) with mucosal impedance testing|
16078700|NCT02318849|Behavioral|Web intervention|interactive website using social media and gamification
16078701|NCT02318836|Drug|Lofexidine Hydrochloride (HCl) tablets|Lofexidine HCl tablets (two 200 µg tablets) will be administered orally with 240 mL room temperature tap water as a single 400 µg dose in the morning on Day 1 after a 10 hour overnight fast.
16078702|NCT02318823|Other|Beer (alcoholic)|Beer (individually calculated amount aiming to achieve a blood-alcohol-centration of 0.4g/kg)
16078703|NCT02318823|Other|Placebo (non-alcoholic beer)|Non-alcoholic beer serves as Placebo.
16078704|NCT02318810|Drug|Rocuronium 0.3 mg/kg|Patients receive rocuronium 0.3 mg/kg
16078705|NCT02318810|Drug|Rocuronium 0.6 mg/kg|Patients receive rocuronium 0.6 mg/kg
16078706|NCT02318810|Drug|Rocuronium 0.9 mg/kg|Patients receive rocuronium 0.9 mg/kg
16078707|NCT02318810|Drug|Placebo|Patients receive saline
16078708|NCT02318797|Behavioral|Patient Self-Directed Care|Patient self-management toolkits, web portal with information on health conditions, personal health care use data, health tracking tools and wellness programs
16078709|NCT02318797|Behavioral|Provider-Supported Integrated Care|Registered nurse on staff at community mental health centers with access to patient-level physical health information to: 1) work with patients on coordinating their care, 2) enhance communication between providers and payer, and 3) provide patient wellness support and education
16078710|NCT02318784|Drug|Carfilzomib|
16078711|NCT02318771|Radiation|Radiation Therapy (RT)|Undergo RT
16078712|NCT02318771|Drug|MK-3475|Given IV
16078713|NCT02318758|Drug|UT-15C|sustained release oral treprostinil
16078714|NCT02318758|Other|ethanol|Absolut 100 vodka
16078715|NCT02318745|Behavioral|Culturally Informed Family Treatment for Adolescents|Family Therapy, Psycho-educational Modules, Individual therapy sessions
16078716|NCT02318745|Behavioral|Individual Treatment|Cognitive Behavior Therapy, Interpersonal psychotherapy, social skills training, anger control training, problem solving skills, assertiveness training, and the Empty chair technique from Gestalt therapy
16078717|NCT02318732|Behavioral|APPS intervention|Contact with and recovery of firearms from individuals who are prohibited from possessing them
16078718|NCT02318719|Drug|Placebo|Placebo
16078719|NCT02318719|Drug|DS-5565|
16078720|NCT02318706|Drug|DS-5565|
16078721|NCT02318706|Drug|placebo|
16078722|NCT02318693|Drug|Sitagliptin|Sitagliptin 50 mg orally once a day before breakfast for 14 days
16078723|NCT02318693|Drug|Glibenclamide|Glibenclamide 1.25 mg orally twice a day (2.5 mg/day) before breakfast and dinner for 14 days
16078724|NCT02318680|Other|Review of follow home visits after discharge from Nykøbing Falster Hospital|The intervention is follow home visits which is randomized and is an intervention that is assigned by the investigator.
16078725|NCT02318667|Biological|Golimumab|Golimumab 50mg/0.5 mL in a single-use, ready-to-use autoinjector. Golimumab is a fully human anti-TNF (tumor necrosis factor) alpha monoclonal antibody that will be administered SC.
16078726|NCT02318654|Other|Ice Pack|Subjects will have 600 grams of ice in clear plastic bag size 18 x 23 cm applied to the randomized axilla for 10 minutes. After 10 minutes, the ice pack will be removed and laser hair treatment will be performed.
16078727|NCT02318654|Drug|Topical EMLA cream|Topical EMLA will be applied approximately 2 mm thick to the randomized axilla with a wooden tongue depressor wrapped with impermeable plastic occlusion dressing for 60 minutes. After 60 minutes, the drug will be removed with regular gauze and saline and laser hair treatment will be performed.
16078728|NCT02318641|Device|oximetry|Retinal oximetry will be performed with Oxymap.
16078729|NCT02318628|Device|Cardio Ankle Vascular Index (CAVI) of the Vasera system VS1500N|"CAVI will be measured using the Vasera device (VS1500 n - Fukuda Denshi co, Japan). This device is easy to use and calculates automatically the CAVI.
~CAVI measurements will be performed according to the manufacturer Measurements will be performed after five to ten minute - period of rest in order to obtain a steady hemodynamic state and to limit measurements variability."
16078730|NCT02318615|Procedure|Immediate Axillary Plasty|Immediate Axillary Plasty would be performed to reduce the formation of scar in the axilla.
16078731|NCT02318602|Drug|Cannabidiol Oral Solution|An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
16078732|NCT02318576|Other|Cognitive Training|Computerized Cognitive Training: The online computer training program will be administered on the participants' home computer. The training program will consist of a total of 36 sessions (3 times/week for 12 weeks). Each session will last no more than 60 minutes and consist of five different cognitive exercises designed to improve cognitive processing speed, memory and executive function. All exercises will involve visual stimuli and a motor response (key or button press). Exercises will be adaptive to participants' individual ability and start with minimal difficulty.
16078733|NCT02318563|Drug|Cannabidiol Oral Solution|An oral solution containing pharmaceutical grade cannabidiol (nonplant-based)
16078734|NCT02318563|Drug|Placebo Solution|A matching oral solution containing no cannabidiol
16078735|NCT02318550|Other|MRI Scan|"The MRI will be performed with a 1.5 T scanner utilizing institutional protocols and the following settings:
~Normal operating mode
~SAR ≤ 2.0 W/kg per patient."
16078736|NCT02318537|Drug|Cannabidiol Oral Solution|An oral solution containing pharmaceutical grade cannabidiol (nonplant-based).
16078737|NCT02318537|Drug|Placebo Solution|A matching oral solution containing no cannabidiol.
16078738|NCT02318511|Procedure|Knee injection|Injection into knee for the treatment of Osteoarthritis
16078739|NCT02318511|Other|ReNu amniotic allograft|
16078740|NCT02318511|Device|placebo saline|
16078741|NCT02318511|Device|Hyaluronic Acid|
16078742|NCT02318498|Procedure|CMR|Intervention performed 2-4 days after admission to hospital with the latest CMR technique including sensitive oedema sequences using T1 mapping
16078743|NCT02318485|Biological|Limbal epithelial stem cell graft|
16078744|NCT02318472|Device|VACOped orthosis|Weight-bearing orthosis with adjustable range of motion of the ankle
16078745|NCT02318472|Device|Plaster cast|Lower limb plaster cast
16078746|NCT02318459|Other|high intensity interval training-HIIT|HIIT 4 times a week, 30 minutes duration
16078747|NCT02318459|Other|Traditionnal group rehabilitation|Traditionnal group rehabilitation, 3 times a week, 1 hour duration
16078748|NCT02318446|Drug|Folic Acid|Test group(n= 24) Existing Anti-epileptic Drugs + Oral Folic acid 1mg tablet daily for 1month
16078749|NCT02318446|Drug|Saccharine|Placebo group(n=12) Existing Anti-epileptic Drugs + Oral saccharine 10 mg tablet daily for 1month
16078750|NCT02318433|Drug|Dexamethasone|Data demonstrates that low doses of dexamethasone preserves chondrocyte viability, protects collagen, and maintains proteoglycan synthesis in cartilage subjected to injurious compression.
16078751|NCT02318433|Drug|Saline|
16078752|NCT02318420|Other|The PartoMa intervention|WHO partogram, locally developed and achievable labour management guidelines (PartoMa guidelines), continual in-house training
16078753|NCT02318407|Drug|AMG 403|AMG 403 for the treatment of subjects with osteoarthritis
16078754|NCT02318407|Drug|Placebo|contains no active drug
16078755|NCT02318394|Biological|MEDI0562|Subjects will receive MEDI0562 until unacceptable toxicity, confirmed disease progression or other reason for treatment discontinuation develops.
16078756|NCT02318381|Procedure|Dissection of the superior transverse scapular ligament|After treatment of the rotator cuff tear, the arthroscopic procedure will also proceed with the dissection of the superior transverse scapular ligament, in order to release pressure from the suprascapular nerve.
16078757|NCT02318368|Drug|Ficlatuzumab|
16078758|NCT02318368|Drug|Erlotinib|
16078759|NCT02318368|Drug|placebo|
16078760|NCT02318355|Other|normal saline|Crystalloid intravenous solution
16078761|NCT02318355|Other|lactated ringers|Crystalloid intravenous solution
16078762|NCT02318342|Drug|Warfarin|Patients with prosthetic valve abnormalities suggestive of thrombus will be administered anticoagulation therapy with Vitamin K antagonists (Warfarin) for 3 months with goal INR 2-3, followed by repeat contrast CT of the chest and transthoracic imaging. Repeat imaging following 3 months of anticoagulation therapy is performed to evaluate the response to anticoagulation therapy.
16078764|NCT02318316|Other|Exhaled breath condensate|Breath condensate samples will be collected with a commercially available condenser (EcoScreen®, Erich Jaeger, Germany). Subjects will breathe through a mouthpiece and a two-way non-rebreathing value in which inspiratory and expiratory air were separated, and saliva was trapped. They will be asked to breathe at a normal frequency and tidal volume for 15 minutes while wearing nose clips, allowing collection of 1.5-2.5 mL of condensate. After collecting this, pH will be measured and the waste collection will be stored at -80 degrees. Then 8 isoprostane and nitrotyrosine will be measured collectively
16078765|NCT02318303|Drug|GSP 301-1 NS (QD)|GSP 301-1 NS (665 μg olopatadine hydrochloride/50 μg mometasone furoate) administered as 2 sprays/nostril
16078766|NCT02318303|Drug|GSP 301-2 NS (BID)|GSP 301-2 NS (665 μg olopatadine hydrochloride/25 μg mometasone furoate) administered as 2 sprays/nostril
16078767|NCT02318303|Drug|GSP 301 Placebo NS|GSP 301 placebo NS administered as 2 sprays/nostril
16078768|NCT02318303|Drug|Olopatadine HCl-1 NS (QD)|Olopatadine HCl-1 NS (665 μg) administered as 2 sprays/nostril
16078769|NCT02318303|Drug|Olopatadine HCl-2 NS (BID)|Olopatadine HCl-2 NS (665 μg) administered as 2 sprays/nostril
16078770|NCT02318303|Drug|Mometasone Furoate-1 NS (QD)|Mometasone furoate -1 NS (50 μg) administered as 2 sprays/nostril
16078771|NCT02318303|Drug|Mometasone Furoate-2 NS (BID)|Mometasone furoate-2 NS (25 μg) administered as 2 sprays/nostril
16078772|NCT02318290|Drug|Opiates|Mechanically ventilated patients receiving opiates for more than 96 hours will be evaluated for withdrawal symptoms upon weaning of the opiates
16078773|NCT02318277|Drug|MEDI4736|MEDI4736 administered intravenously (IV) every two weeks (q2w)
16078774|NCT02318277|Drug|INCB024360|INCB024360: Oral daily dosing
16078775|NCT02318264|Device|Kinesio Tape|Elastic tape placed over the skin
16078776|NCT02318251|Other|Involuntary muscle contractions|Physiotherapy program focusing on involuntary pelvic floor muscle fast contractions: 9 individual physiotherapies taking place within 16 weeks. During these 16 weeks the participants will perform a home program 3x/week (3x/day) during week 1-5 and 3x/week (1x/day) in week 6-16. In the following 6 months they will perform the home program 3x/week (1x/day). This program includes the standard physiotherapy.
16078777|NCT02318251|Other|Voluntary muscle contractions|Physiotherapy program (physiotherapy standard program) focusing on voluntary fast contractions: 9 individual physiotherapies taking place within 16 weeks. During these 16 weeks the participants will perform a home program 3x/week (3x/day) during week 1-5 and 3x/week (1x/day) in week 6-16. In the following 6 months they will perform the home program 3x/week (1x/day).
16078778|NCT02318238|Other|6 minutes walking test|
16078779|NCT02318238|Other|6 minutes step test|
16078780|NCT02318238|Other|4 meters gait speed|
16078781|NCT02318225|Drug|Misoprostol|"Misoprostol (400µg) will be administered vaginally 12 hours before office hysteroscopy. A rigid 2.9 mm hysteroscope with 30° forward oblique lens will be used in the procedure. The uterine cavity will be distended by warm saline at a pressure between 60-80 mmHg. All the procedures will be performed during the proliferative phase using the vaginoscopic approach as described by Betocchi and Selvaggi in 1997 . All the procedures will be diagnostic.
~Pain intensity will be assessed by visual analogue scale during the examination and 30 minutes after the procedure. A visual analogue scale ranging from 0 to 10 will be used (zero indicates no pain and 10 indicates the worst possible experienced pain)."
16078782|NCT02318225|Drug|Placebo|"Placebo will be administered vaginally 12 hours before office hysteroscopy. A rigid 2.9 mm hysteroscope with 30° forward oblique lens will be used in the procedure. The uterine cavity will be distended by warm saline at a pressure between 60-80 mmHg. All the procedures will be performed during the proliferative phase using the vaginoscopic approach as described by Betocchi and Selvaggi in 1997 . All the procedures will be diagnostic.
~Pain intensity will be assessed by visual analogue scale during the examination and 30 minutes after the procedure. A visual analogue scale ranging from 0 to 10 will be used (zero indicates no pain and 10 indicates the worst possible experienced pain)."
16078783|NCT02318212|Device|Dilapan-S|Synthetic osmotic dilators Dilapan-S or Dilasoft for cervical priming prior to induced abortion
16078784|NCT02318199|Procedure|Anesthesia recovery after intracranial surgery|Intracranial surgery for brain tumor, traumatic brain injury, intracranial hemorrhage, subarachnoid hemorrhage and infection.
16078785|NCT02318173|Device|Dilapan-S|Synthetic osmotic dilators Dilapan-S, Dilasoft for cervical ripening prior to induction of labor in women with unfavourable cervix
16078786|NCT02318160|Other|measurement of oxidant status in AIT|measurement of thyroid-stimulating hormone (TSH) and free thyroxin (FT4), as well as anti-thyroid peroxidase antibodies (TPOAb) and anti-thyroglobulin antibody (TgAb) were done in addition to assessment of malondialdehyde (MDA) and total antioxidant capacity (TAC) levels as an oxidative stress markers
16078787|NCT02318147|Procedure|Fecal Microbiota Transplantation|FMT by retention enema with fresh bacteria from healthy donor
16078788|NCT02318147|Drug|The traditional treatment|the traditional treatments according to associated guidelines
16078789|NCT02318134|Procedure|Fecal Microbiota Transplantation|FMT via a nasoduodenal tube with fresh bacteria from healthy donor
16078790|NCT02318134|Drug|normal saline|Normal saline via a nasoduodenal tube.
16078791|NCT02318121|Procedure|Amniotomy first|rupture of membranes to augment labor
16078792|NCT02318121|Procedure|Oxytocin first|Administration of oxytocin to augment labor
16078793|NCT02318121|Procedure|Amniotomy and oxytocin|Rupture of membranes and administration of oxytocin to augment labor
16078794|NCT02318121|Drug|Oxytocin|
16078795|NCT02318108|Other|Mentored organizational change|Practices are given basic education related to population-based care and are supported by physician peer mentors and given feedback on performance.
16078796|NCT02318108|Other|Education only|Practices are given basic education related to population-based care and are given feedback on performance.
16078797|NCT02318095|Drug|Gemcitabine/nab-Paclitaxel|Prospective, single arm study ; eligible subjects will recieve 2 cycles of neoadjuvant Gemcitabine/nab-Paclitaxel. All chemotherapy administered to study subjects is standard of care. The chemotherapy combination, gemcitabine/nab-paclitaxel, is considered to be a standard-of-care, non-investigational chemotherapy combination; chemotherapy dosing and treatment schedule will be managed by the treating medical oncologist. Restaging will be completed post chemotherapy.
16078885|NCT02317419|Drug|RO6927005|RO6927005 administered intravenously on Days 1, 3, and 5 of each 28-day treatment cycle (QOD x 3).
16078798|NCT02318095|Radiation|Radiation therapy|5 fractions of hypofractionated IGRT or IMRT at 5Gy per fraction will be delivered before surgery. Restaging will be completed post radiation therapy.
16078799|NCT02318095|Other|Sugical resection|Surgical resection of the pancreas post radiation therapy
16078800|NCT02318095|Drug|Adjuvant chemotheapy|Adjuvant chemotherapy may be given after surgery at the clinical discretion of the medical oncologist
16078801|NCT02318082|Drug|Interleukin-2|
16078802|NCT02318069|Biological|FSME-immune|0.5 ml im as scheduled in the 5 arms
16078803|NCT02318056|Other|Aquacel® Ag Burn Glove|burn dressing
16078804|NCT02318056|Other|Mepilex® Transfer Ag|burn dressing
16078805|NCT02318056|Drug|antibiotic|antibiotic burn dressing
16078806|NCT02318043|Drug|inhaled corticosteroids (usually budesonide/fomorterol 160/4.5mcg; fluticasone/salmeterol 250/50mcg)|Patients with uncontrolled and partly controlled asthma, following accomplishment of study 1, were invited to participate in observational study (study 2), which sought to determine usefulness of both BPTs in reflecting improvement of asthmatic symptoms following 3 and 6 months of moderate-dose ICSs treatment (400~800μg budesonide or equivalent). Patient continued to administer their original ICS during follow-up. During two follow-up visits (3 months apart), AMP-BPT, His-BPT and Hogg's symptom scores were reassessed.
16078807|NCT02318017|Drug|Methylphenidate|Before neurocognitive testing, Methylphenidate/Placebo will be given
16078808|NCT02318017|Drug|Placebo|
16078809|NCT02318004|Other|Home Monitoring|Non invasive nocturnal monitoring of heart and respiratory rate and subjects movement out of bed.
16078810|NCT02317991|Drug|nab-paclitaxel|nab-paclitaxel 125 mg/m^2 IV
16078811|NCT02317991|Biological|ramucirumab|Ramucirumab 8 mg/kg IV
16078812|NCT02317978|Procedure|ICSI|records of women who had ICSI will be reviewed and analysed for determining FSI
16078813|NCT02317965|Other|Maternal Blood Draw|Maternal Blood Draw
16078814|NCT02317952|Other|Experimental Extensively Hydrolyzed Formula|
16078815|NCT02317952|Other|Active Comparator Formula|
16078816|NCT02317939|Other|instruction|online instruction tutorials at followup visits
16078817|NCT02317939|Other|standard baseline instruction|self-guidance at followup visits
16078818|NCT02317926|Drug|Levothyroxine|
16078819|NCT02317926|Drug|Levothyroxine Plus Liothyronine|
16078820|NCT02317926|Drug|Desiccated Thyroid Extract|
16078821|NCT02317900|Biological|TV005|TV005 is a live attenuated recombinant tetravalent dengue virus vaccine. It will be administered as a 0.5 mL dose containing 10^3 plaque forming units (PFUs) of each component (10^3.3 PFUs/mL of rDEN1∆30, 10^4.3 PFU/mL of rDEN2/4∆30(ME), 10^3.3 PFU/mL of rDEN3∆30/31-7164 and 10^3.3 PFU/mL of rDEN4∆30). It will be delivered by subcutaneous injection in the deltoid region of the upper arm.
16078822|NCT02317900|Biological|Placebo|The placebo vaccine will be administered as a 0.5 mL dose delivered by subcutaneous injection in the deltoid region of the upper arm.
16078823|NCT02317900|Biological|rDEN2∆30-7169|rDEN2∆30-7169 is a live recombinant attenuated DENV-2 candidate vaccine virus. It will be administered as a 0.5 mL dose containing 10^3 PFUs of rDEN2∆30-7169. It will be delivered by subcutaneous injection in the deltoid region of the upper arm.
16078824|NCT02317887|Biological|RS1 AAV Vector|Gene transfer by intravitreal injection of the RS1 AAV vector (AAV8-scRS/IRBPhRS)
16078825|NCT02317874|Drug|Carboplatin|Given IV
16078826|NCT02317874|Drug|Paclitaxel|Given IV
16078827|NCT02317874|Drug|Talazoparib|Given PO
16078828|NCT02317861|Drug|RDEA3170|Oral Treatment
16078829|NCT02317861|Drug|Febuxostat|Oral Treatment
16078830|NCT02317861|Drug|Benzbromarone|Oral Treatment
16078831|NCT02317848|Other|polygraphy and ECG|polygraphy and ECG during hospitalisation for acute heart failure to see Persistence of the severity of SAS after 2 months
16078832|NCT02317835|Device|DFUPS|The DFUPS device is a two-camera instrument for capturing images of feet
16078833|NCT02317809|Drug|Liquid pergoveris|All subjects will be administered with 900 IU of r-hFSH and 450 IU of r-hLH solution (Liquid Pergoveris) as subcutaneous injection using a disposable pen-injector on Day 1 in either first intervention period or second intervention period.
16078834|NCT02317809|Drug|Freeze-dried pergoveris|All subjects will be administered with 900 IU of r-hFSH and 450 IU of r-hLH freeze-dried powder (Freeze-dried Pergoveris) as subcutaneous injection on Day 1 in either first intervention period or second intervention period.
16078835|NCT02317796|Drug|MLR-1023|Each subject will receive an oral dose of placebo or MLR-1023 once before breakfast and either placebo (placebo and q.d. dose groups) or a second dose of MLR-1023 (b.i.d. dose groups) before dinner for 4 weeks.
16078836|NCT02317783|Drug|[18F]Flutemetamol|Brain scan with imaging tracer that binds to amyloid plaques
16078837|NCT02317783|Drug|[18F]fluoro-2-deoxy-D-glucose (FDG)|Brain scan with imaging tracer used for measuring glucose metabolism in the assessment, diagnosis, and staging of patients with cancer
16078838|NCT02317783|Diagnostic Test|Functional Magnetic Resonance Imaging (fMRI)|Brain scan to assess regions of abnormal volume and density
16078839|NCT02317770|Drug|Lidocaine Spray|5 puffs of 10% Lidocaine spray is administered every 5 minutes for 4 times. Then the patient is undergone procedure 5 minutes later.
16078840|NCT02317770|Drug|Nebulized Lidocaine|The patient receives 2.5 mL of 10% lidocaine is used by nebulizer under oxygen flow 6-7 LPM for 15 minutes prior the procedure.
16078841|NCT02317744|Drug|Naltrexone and bupropion combination|
16078842|NCT02317744|Other|Pill Placebo|
16078843|NCT02317731|Other|Straw|Bowel preparation ingestion with a straw
16078844|NCT02317718|Other|monitor reproductive outcome|
16078845|NCT02317705|Drug|OTL38|
16078846|NCT02317705|Device|Near infrared camera imaging system|Near infrared camera imaging system
16078847|NCT02317705|Procedure|Laparotomy|primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery
16078848|NCT02317692|Behavioral|Parent training|
16078886|NCT02317419|Drug|gemcitabine|gemcitabine administered according to local label on Days 1, 8, and 15 of each 28-day cycle.
16078887|NCT02317419|Drug|nab-paclitaxel|nab-paclitaxel administered according to the local label on Days 1, 8, and 15 of each 28-day cycle.
16078888|NCT02317406|Drug|Biostime probiotics sachet children's formula|Biostime probiotics sachet children's formula,1.5g Oral Single dose
16078849|NCT02317679|Drug|Bosentan|Patients with PWS resistant to PDL treatment will be included. The treatment by Bosentan (twice daily :2 mg/kg and maximum 62,5 mg) will be given 1 day before the PDL irradiation (maximum area treated 100 cm2) and continued for 14 days. The clinical improvement of the lesions will be evaluated by comparing standardized pictures, 14 days after the end of the treatment by Bosentan which corresponds to 1 month after the laser PDL irradiation. The evaluation will be realized by 2 independent physicians blinded to the area treated or not. Hemoglobin and SGOT/SGPT will be controlled before and after the treatment by Bosentan.
16078850|NCT02317679|Device|Pulsed dye laser (PDL)|A test area of the PWS will be treated by pulsed dye laser (PDL) (λ= 595 nm, 7 mm spot diameter, τp= 1.5 ms, same energy density used at the last session for each subject).
16078851|NCT02317666|Procedure|Medication Review|A structured 5-step multidisciplinary medication review (STRIP method) as described in the multidisciplinary guidelines by the Nederlands Huisartsen Genootschap (2013) including the objective to reduce the DBI, performed by the pharmacist in collaboration with the general practitioner
16078852|NCT02317640|Drug|Testosterone Gel applied by a pump|After being diagnosed with low testosterone levels the participant will be given a 30-day supply of the Testosterone/placebo gel (40.5 mg/day). The gel is to be applied every morning on clean and dry area of skin of the upper arms and shoulders.
16078853|NCT02317640|Other|Stand Training|Stand training with BWST with manual assistance. Participant is placed on treadmill in an upright position and suspended in a harness by an overhead cable. A trainer will aid the participant in pelvis and trunk stabilization, by applying anterior forces at the pelvis and/or posterior forces at the shoulders and ensure that the trunk and pelvis are not flexed or hyper-extended.
16078854|NCT02317640|Device|Electrical Stimulation|Electrical Stimulation (ES) will be applied via bifurcated leads and self-adhesive reusable surface electrodes. The electrodes will be applied over the motor points of both legs. Two electrodes will be used for contracting each muscle.
16078855|NCT02317627|Drug|KD025|
16078856|NCT02317614|Behavioral|SteadyRx|The proposed intervention consists of four core elements. The intervention will include a Smartphone application that allows direct interaction with the SteadyRx system, as well as automatic events controlled via a central server. The CONSULT element will facilitate patient-provider communication with links to care providers and other care resources. The REMIND element will provide telephonic reminders for late doses. The OBSERVE element will feature electronically observed dosing through time-stamped video recordings made on the Smartphone and sent securely to a central server. The REWARD element will feature monetary incentives designed to reinforce short- and long-term medication adherence and promote reductions in viral load.
16078857|NCT02317601|Drug|methylprednisolone sodium succinate|Single dose Intravenous
16078858|NCT02317601|Drug|placebo saline|
16078859|NCT02317588|Dietary Supplement|Flax Oil|Participants will consume capsules containing flax oil at a dose of 4 grams of ALA per day (8 capsules a day) with a meal for 28 days (4 weeks).
16078860|NCT02317588|Dietary Supplement|Fish Oil|Participants will consume capsules containing fish oil at a dose of 4 grams DHA + 0.8 grams EPA per day (8 capsules) for 28 days (4 weeks).
16078861|NCT02317575|Biological|LY900014|Administered SC
16078862|NCT02317575|Biological|Insulin Lispro|Administered SC
16078863|NCT02317562|Drug|I10E|Patients who met all eligibility criteria will receive 0.5 g/kg of IMP every 3 weeks during 45 weeks.
16078864|NCT02317549|Drug|LB1148|
16078865|NCT02317549|Drug|Placebo|
16078866|NCT02317536|Dietary Supplement|Carnipure Product 1|
16078867|NCT02317536|Dietary Supplement|Carnipure Product 2|
16078868|NCT02317536|Other|Placebo|Placebo
16078869|NCT02317523|Behavioral|Behavioral Activation|Six face-to-face sessions (60 minutes each) of Behavioral Activation (BA) therapy
16078870|NCT02317523|Behavioral|Information and Support|Six face-to-face sessions (60 minutes each) of Supportive Therapy
16078871|NCT02317510|Procedure|combined anesthesia|Combined Spinal Epidural Anesthesia for laparoscopic cholecystectomy
16078872|NCT02317510|Procedure|general anesthesia|General anesthesia for laparoscopic cholecystectomy
16078873|NCT02317497|Other|Intensive Care Sedation (depth, level)|As far as sedation is concerned, this will be adapted to all patients before randomization in the first 3 days according to what the diagnosis and acute treatment of the underlying disease demands. This will be deep sedation or even general anesthesia (for operative procedures) in most cases. After 72h at the sedation level of the respective randomization result, both groups will tried to be weaned from sedation with the goal of awakening, weaning from ventilation, overall de-escalation and transfer to rehabilitation as far as the course of the disease and the occurrence of complications allows. This reduction of sedation will follow individual regimes at he discretion of the treating physician. However, if cessation of sedation violates safety-limits (see below, Tab. 2) or is not feasible for other reasons, return to the level the patient was initially randomized for (or even below that) is mandatory with a re-assessment of safety for sedation weaning after 12h aimed for.
16078874|NCT02317497|Drug|Vasopressors to maintain normal blood pressure values, if needed|
16078875|NCT02317497|Drug|Osmotherapeutics to lowr intracranial pressure, if needed|
16078876|NCT02317497|Procedure|Endovascular stroke care to treat brain vessel occlusions, if needed|
16078877|NCT02317497|Procedure|Decompressive neurosurgery, if needed|
16078878|NCT02317484|Drug|Ipragliflozin (SGLT2 inhibitor)|
16078879|NCT02317471|Biological|autologous gp96 vaccination|"Vaccination of gp96 derived from autologous tumor tissue. Treatment will be started between 3-6 weeks after the surgery.
~gp96 of 25ug in 1mL normal saline s.c. on days 1 of each cycle, up to a maximum of 10 doses (1 cycle= 7 days). 200-400mg cyclophosphamide i.v. 1-3 days before each gp96 infusion."
16078880|NCT02317471|Drug|Oxaliplatin+S-1|"Treatment will be start at the 5th week after the surgery.
~S-1: 40~60mg bid，d1~14 q3W; oxaliplatin:130mg/m2，iv drip for 2h，d1,q3W 6 cycles."
16078881|NCT02317458|Biological|Experimental|One active arm with standard of car and treatment with C3BR-CQR-1 using intramyocardial injection
16078882|NCT02317458|Biological|Sham comparator|One arm with standard of care undergoing a sham procedure
16078883|NCT02317432|Behavioral|Comparison of a combined CBT + exercise intervention and enhanced usual care|
16078884|NCT02317419|Drug|RO6927005|RO6927005 administered intravenously on Days 1, 3, and 5 of each 21-day treatment cycle (QOD x 3).
16078944|NCT02316964|Biological|aldesleukin|Given SC
16078889|NCT02317406|Drug|Biostime probiotics sachet children's formula（placebo）|Biostime probiotics sachet children's formula（placebo）,1.5g Oral Single dose
16078890|NCT02317393|Other|K5-RGD PET|Both PET examinations will be performed within 4-6 weeks after the end of chemotherapy
16078891|NCT02317393|Other|FDG|Both PET examinations will be performed within 4-6 weeks after the end of chemotherapy
16078892|NCT02317341|Drug|Ketamine|Single intravenous dose
16078893|NCT02317341|Drug|Placebo (saline)|Given intravenously over 40 minutes
16078894|NCT02317341|Drug|Ketamine|Single intravenous dose given over 40 minutes
16078895|NCT02317341|Drug|Midazolam|Given intravenously over 40 minutes
16078896|NCT02317341|Drug|Midazolam(placebo)|Given intravenously over 40 minutes
16078897|NCT02317302|Device|FDG-PET/MR|
16078898|NCT02317302|Device|FDG-PET/CT|
16078899|NCT02317289|Device|Detection of freezing|single wireless inertial sensor placed on the patients's lower limbs to detect freezing of gaitin Parkinsonian patients
16078900|NCT02317276|Drug|Triamcinolone 0.1%|Topical ointment
16078901|NCT02317263|Drug|testosterone|
16078902|NCT02317263|Drug|placebo gel|
16078903|NCT02317250|Procedure|Amyloid imaging|Amyloid imaging brain scans are administered once to all arms.
16078904|NCT02317250|Procedure|FDG-PET|[F-18] FDG-PET brain scans are administered once to all arms.
16078905|NCT02317237|Procedure|Local anesthesia|Conscious sedation
16078906|NCT02317224|Procedure|"3-Hole subxiphorid and subcostal approach"|"3-Hole subxiphorid and subcostal approach anterior mediastinum tumor resection"
16078907|NCT02317224|Procedure|Trans sternal approach|Trans sternal approach anterior mediastinum tumor resection
16078908|NCT02317224|Procedure|VATS approach|Video-assisted thoracoscope anterior mediastinum tumor resection
16078909|NCT02317211|Dietary Supplement|Anthocyanin|Extract of blueberry and huckleberry （MEDOX，http://www.medox.no/english）
16078910|NCT02317211|Dietary Supplement|placebo|starch
16078911|NCT02317198|Drug|Clopidogrel|
16078912|NCT02317198|Drug|Ticagrelor or Prasugrel|
16078913|NCT02317185|Device|genex bone graft with bone graft|
16078914|NCT02317185|Other|autogenous bone graft|
16078915|NCT02317172|Other|Gel-based artificial saliva|Gel-based artificial saliva is a novel gel-like, edible moisturizing gel designed to relieve dry mouth.
16078916|NCT02317159|Drug|Imatinib|400mg imatinib qd PO
16078917|NCT02317146|Drug|Magnesium Sulfate|Magnesium sulfate is the drug used as prophylaxis to eclampsia in women with severe preeclampsia
16078918|NCT02317133|Biological|Blood samples|Compared to routine practice, 3 additional tubes of blood will be drawn for the observational needs of this study.
16078919|NCT02317133|Biological|Stool samples|Stool samples will be collected for the observational needs of this study (and are not part of routine practice).
16078920|NCT02317120|Genetic|NGS BRCA 1 and BRCA 2 full sequencing|
16078921|NCT02317120|Genetic|Multiplex ligation-dependent probe amplification (MPLA) BRCA1 BRCA2|Firstly many pairs of probes, containing: a universal primer sequence, a specific hybridisation target sequence and a stuffer DNA region to vary the size of the resulting product, are hybridised adjacent to each other on the target DNA strand .The two adjacent probe sequences are ligated to form a continuous section of DNA.The ligated probes are then amplified using PCR. The amplified fragments are analysed by capillary electrophoresis to detect the different fragment lengths. These data can be analysed to show the relative copy number of each fragment that is present in the sample.
16078922|NCT02317094|Other|Blood-flow restricted training|The intervention consists of low-intensity blood-flow restricted training involving 5 lower extremity exercises performed uni lateral in four sets to concentric failure with an intensity of approximately 25 repetition maximum (25RM).
16078923|NCT02317094|Drug|Care as usual|The intervention consists of various DMARDs, which are given to the patients depending on their physical state and the disease activity.
16078924|NCT02317081|Device|Axetis Inert Coronary Stents|de novo coronary artery stenosis in native vessels
16078925|NCT02317068|Device|HBR|
16078926|NCT02317068|Device|DD|
16078927|NCT02317055|Other|imaging|
16078928|NCT02317042|Device|Juno|Juno device set to ST mode with participant's current therapy settings.
16078929|NCT02317042|Device|Juno|Juno device set to AutoEPAP iVAPS mode.
16078930|NCT02317042|Device|Juno|Juno device set to Fixed EPAP iVAPS mode.
16078931|NCT02317029|Device|Cardioversion with a pulsed biphasic waveform|Cardioversion will be performed by a pulsed biphasic (Multipulse Biowave®) waveform (Schiller Defigard 5000) with an energy setting of 90J, 120J, 150J, 200J. Primary endpoint: The proportion of patients in sinus rhythm four hours post cardioversion.
16078932|NCT02317029|Procedure|Normoxia during cardioversion|Patients will be treated with room air with a flow of 10-15 L/minute for 3 minutes prior to cardioversion and nasal room air with a flow of 3 L/minute for 30 minutes following cardioversion
16078933|NCT02317029|Device|Cardioversion with a biphasic truncated exponential waveform|Cardioversion will be performed by a biphasic truncated exponential waveform (LIFEPAK 20), with a energy setting of 100J, 150J, 200J, 250J. Primary endpoint: The proportion of patients in sinus rhythm four hours post cardioversion.
16078934|NCT02317029|Procedure|Hyperoxia during cardioversion|Patients will be treated with 100% oxygen with a flow of 10-15 L/minute for 3 minutes prior to cardioversion and nasal 100% oxygen with a flow of 3 L/minute for 30 minutes following cardioversion
16078935|NCT02317016|Procedure|Pharmacokinetic sampling - AZD9291|Blood sampling to measure AZD9291
16078936|NCT02317016|Drug|AZD9291 tablet dosing|Part A: AZD9291 80mg tablet taken from Days 4 to 35. Part B: AZD9291 80mg tablet taken daily for 12 months.
16078937|NCT02317016|Drug|Rosuvastatin|Rosuvastatin (BCRP substrate) 20mg taken once daily on Days 1 and 32 (Part A) .
16078938|NCT02317016|Procedure|Pharmacokinetic sampling - rosuvastatin|Blood sampling to measure rosuvastatin levels
16078939|NCT02317016|Procedure|Pharmacokinetic sampling - AZ5140 and AZ7550|Blood samples to measure levels of AZ5140 and AZ7550
16078940|NCT02317003|Behavioral|Intervention PPIL|
16078941|NCT02317003|Behavioral|Control OR|
16078942|NCT02316964|Drug|decitabine|20 mg/m2 Given IV (intravenous) for 5 days over 60 minutes
16078943|NCT02316964|Biological|natural killer cell therapy|Undergo infusion of allogeneic NK cells on day 0
16078946|NCT02316951|Device|single-arm study group|Study participants will wear a small motion detection device and a regular Webcam will be placed near the wall facing the bed in each patient's hospital room. Study participants will be questioned about their sociodemographic, pain, and health history.
16078947|NCT02316925|Dietary Supplement|Setria glutathione supplement|500 mg/day capsule taken in the morning
16078948|NCT02316925|Dietary Supplement|Crystalline Cellulose|500 mg/day capsule taken in the morning
16078949|NCT02316912|Drug|ATX2417|Randomised double blind parallel group ascending dose assessment
16078950|NCT02316912|Drug|Placebo|Randomised double blind parallel group ascending dose assessment
16078951|NCT02316899|Drug|linaclotide|Oral administration once daily
16078952|NCT02316899|Drug|Placebo|Oral administration once daily
16078953|NCT02316886|Device|Coronary intervention|Bioresorbable Vascular Scaffold or Everolimus Eluting stent (EES) +Optimal Medical Treatment
16078954|NCT02316886|Drug|Optimal Medical treatment|
16078955|NCT02316873|Behavioral|Music training|This program was based on the Kodaly and Orff pedagogy and adapted to focus on rhythm and temporal processing.
16078956|NCT02316873|Behavioral|Visual arts|This program emphasized visual-spatial and hand skills as well as creativity.
16078957|NCT02316860|Other|Passive tilt test|Passive tilt test (without pharmacological provocation). After a horizontal supine rest period of 5 min, the tilt table was inclined at 60° head-up position for 30 min. A positive response was defined according to the European Society of Cardiology guidelines for the diagnosis and management of syncope
16078958|NCT02316847|Drug|diazepam nasal spray|
16078959|NCT02316834|Other|Laboratory Biomarker Analysis|Correlative studies
16078960|NCT02316834|Drug|BMN 673|"BMN673 given at a dose of 1 mg orally once daily.
~Participants begin taking BMN 673 tablets by mouth every day, starting on the day of scheduled laparoscopy. Participants take the study drug for at least 7 days before scheduled tumor reduction surgery."
16078961|NCT02316821|Drug|RTA 402|
16078962|NCT02316821|Drug|Placebo|
16078963|NCT02316808|Dietary Supplement|Plant stanol ester|Smoothie that contains plant stanol ester
16078964|NCT02316808|Dietary Supplement|placebo|Smoothie that contains placebo
16078965|NCT02316795|Procedure|Sentinel lymph node biopsy|
16078966|NCT02316795|Device|Goggle-based device with light-emitting diodes (LED)|
16078967|NCT02316795|Drug|Indocynanine Green|This is a infrared fluorescence imaging contrast agent
16078968|NCT02316782|Device|Blinded IVUS assessment|Only the angiogram is used for stent placement
16078969|NCT02316782|Device|Nonblinded IVUS|Angiogram, Grayscale IVUS and VH IVUS used for stent placement pre and post intervention
16078970|NCT02316769|Procedure|King Vision video laryngoscope|Patient intubated with the King Vision Video Laryngoscope
16078971|NCT02316769|Procedure|McGrath MAC video laryngoscope|Intubation with the McGrath MAC video laryngoscope
16078972|NCT02316756|Drug|PF-06648671|Experimental Pfizer compound which will be dosed as oral suspension
16078973|NCT02316756|Drug|Placebo|Placebo which will be given as oral suspension
16078974|NCT02316743|Drug|Levothyroxine supplementation|T4 supplementation for heart failure patients with subclinical hypothyroidism.
16078975|NCT02316730|Drug|Sanchi-Tongshu Capsule (Enteric coated pellets)|Take 0.7g (2 Capsules) of test preparation orally.
16078976|NCT02316730|Drug|Sanchi-Tongshu Capsule|Take 0.4g (2 Capsules) of reference preparation orally.
16078977|NCT02316717|Biological|IMM-124E|IMM-124E
16078978|NCT02316717|Other|Placebo|Matched placebo
16078979|NCT02316704|Device|THA with G7 PPS coted acetabular component|
16078980|NCT02316704|Device|THA with G7 OsseoTi coted acetabular component|
16078981|NCT02316678|Other|No intervention|There is no intervention
16078982|NCT02316665|Device|continuous positive airway pressure|continuous positive airway pressure treatment during three months with adherence recording
16078983|NCT02316665|Device|Sham-continuous positive airway pressure|Sham-continuous positive airway pressure during three months with adherence recording
16078984|NCT02316652|Procedure|Scaling and root planing|Mechanical instrumentation
16078985|NCT02316652|Procedure|Scaling and root planing with solution|Mechanical instrumentation with sodium hypochlorite disinfective solution
16078986|NCT02316639|Other|Neuromuscular Training|The established Neuromuscular Training (NMT) protocol is supervised, progressive program in which the patient maintains balance on three different support surfaces while a clinician administers purposeful manipulations of the support system.1 The patient maintains a single-leg stance on the rollerboard and tiltboard surfaces, and a two-leg stance with one foot on a roller board while the other is on a platform. Participants will complete two training sessions per week, for five weeks for a total of 10 training sessions.
16078987|NCT02316626|Drug|Subcutaneous progesterone|25 mg daily for 14 days
16078988|NCT02316626|Drug|Vaginal progesterone|90 mg daily for 14 days
16078989|NCT02316613|Drug|Rituximab|
16078990|NCT02316600|Device|smart insole|smart insole to encourage the frail elderly person's physical activity and to monitor key parameters of frailty
16078991|NCT02316574|Behavioral|Cognitive Behavioral Coping Skills Therapy|"Cognitive Behavioral Coping Skills Therapy (CBCST) is an individual psychotherapy for alcohol dependence that helps individuals to reduce drinking by addressing the ability to regulate, or cope with alcohol cravings and other emotions that promote alcohol use."
16078992|NCT02316561|Radiation|Single dose ablative radiotherapy|A single dose ablative radiotherapy will be delivered prior to surgery
16078993|NCT02316548|Radiation|Intensity-Modulated Radiation Therapy|Postoperative adjuvant IMRT radiotherapy 50.4 Gy in 28 fractions. In patients not getting postoperative adjuvant chemotherapy the radiation treatment must begin within 140 days after cystectomy. For patients getting adjuvant chemotherapy radiation treatment must start within 49 days of completing chemotherapy.
16078994|NCT02316535|Drug|Capecitabine|adjuvant chemotherapy;
16078995|NCT02316509|Drug|GDC-0927|GDC-0927 will be administered as per schedule specified in the respective arm.
16078996|NCT02316496|Drug|cetuximab|cetuximab 500mg/m²/ IV infusion, (q2w)
16078997|NCT02316496|Drug|Irinotecan|Irinotecan 180mg/m², in 500ml NaCl 0.9% solution, 90 min IV infusion (q2w)
16078998|NCT02316470|Biological|VLA84|a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B
16078999|NCT02316470|Biological|Placebo|phosphate buffered saline (PBS) solution
16079000|NCT02316457|Biological|IVAC_W_bre1_uID|vaccination
16079001|NCT02316457|Biological|IVAC_W_bre1_uID/IVAC_M_uID|vaccination
16079002|NCT02316444|Biological|Hepatitis B vaccine|An eligible participant will receive 3 doses of hepatitis B vaccine ( 20mcg in the deltoid intramuscular). Then their immune response will be assessed. Non responders will receive 3 additional vaccine doses off protocol
16079003|NCT02316418|Device|Hairstetics™ anchoring system|"Overall, up to 360 prosthetic hair implants will be set in the scalp. The procedure will be performed in accordance with the instructions in the device Instructions for Use. Training and certification of operators by the Sponsor is a prerequisite for use of the study device by the former.
~Hair extensions will be attached to the fibers four weeks after the implantation."
16079004|NCT02316405|Other|Arm and Leg Cycling Exercise for Walking after Stroke|
16079005|NCT02316392|Drug|Hyperpolarized Helium-3 MRI|Subjects will inhale Hyperpolarized Helium-3 gas during the MRI. This gas enhances images and the data collected will be used to determine if it can be used to detect BOS earlier than current standard of care.
16079006|NCT02316379|Drug|Hyperpolarized 129 Xenon|During the scans, subject will inhale hyperpolarized Xenon gas for up to 16 seconds per scan, for up to 4 separate MR scans
16079007|NCT02316379|Device|MRI|
16079008|NCT02316366|Device|Astoflo Plus fluid warmer|A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius
16079009|NCT02316353|Biological|C1-esterase inhibitor|
16079010|NCT02316340|Drug|Vorinostat|400mg by mouth daily
16079011|NCT02316340|Drug|Hydroxychloroquine|600mg by mouth daily
16079012|NCT02316340|Drug|Regorafenib|160 mg by mouth daily
16079013|NCT02316327|Drug|gemcitabine, cisplatin and bevacizumab|Therapeutic
16079014|NCT02316314|Procedure|Cardiac magnetic resonance imaging (CMR)|"CMR is a non-invasive way to take a high-resolution image of the heart and vessels. CMR uses powerful magnets and radio waves to obtain the image. During the CMR, you will have a substance injected into your vein called contrast to get a better picture of the heart."
16079015|NCT02316314|Procedure|Exercise-stress test|You will be asked to pedal on a bicycle with your arms to see how much work you can do and how far you can go.
16079016|NCT02316314|Procedure|Echocardiogram (ECHO)|An echocardiogram is an ultrasound of the heart done at rest.
16079017|NCT02316314|Procedure|Cardiac-related blood studies|The blood test involves drawing blood from a vein in the arm by placing a needle in it. The total amount of blood to be drawn for a single visit will be up to 57 mL (12 teaspoons).
16079018|NCT02316301|Drug|Long interval misoprostol|A rigid 2.9 mm hysteroscope with 30° forward oblique lens and outer sheath diameter of 5 mm will be used in the procedure. The uterine cavity will be distended by warm saline at a pressure between 60-80 mmHg. All the procedures will be performed during the proliferative phase using the vaginoscopic approach as described by Betocchi and Selvaggi in 1997. All the procedures will be diagnostic.Pain intensity will be assessed by visual analogue scale during the examination and 30 minutes after the procedure. A visual analogue scale ranging from 0 to 10 will be used (zero indicates no pain and 10 indicates the worst possible experienced pain).
16079019|NCT02316301|Drug|Short interval misoprostol|A rigid 2.9 mm hysteroscope with 30° forward oblique lens and outer sheath diameter of 5 mm will be used in the procedure. The uterine cavity will be distended by warm saline at a pressure between 60-80 mmHg. All the procedures will be performed during the proliferative phase using the vaginoscopic approach as described by Betocchi and Selvaggi in 1997. All the procedures will be diagnostic.Pain intensity will be assessed by visual analogue scale during the examination and 30 minutes after the procedure. A visual analogue scale ranging from 0 to 10 will be used (zero indicates no pain and 10 indicates the worst possible experienced pain).
16079020|NCT02316288|Behavioral|Mindfulness and Acceptance Therapy|Couples will learn psychological flexibility skills including mindfulness, acceptance, and values-based action as well as relational flexibility skills including empathic listening and responding during weekly 1.5-hour long sessions over the course of this 6-week intervention.
16079021|NCT02316288|Behavioral|Health Education|Couples will learn about chronic pain including causes, consequences, and how to talk with their health care professionals about their pain during weekly 1.5-hour long sessions over the course of this 6-week program.
16079022|NCT02316275|Other|No post-operative activity restrictions|Patients are to resume regular activity immediately after mid-urethral sling surgery. The investigators will determine the impact of unrestricted post-operative activity on continence outcomes of mid-urethral sling surgery in women with stress urinary incontinence (SUI). Investigators will measure the effect of unrestricted post-operative activity on early health-related quality of life (HRQOL). A Productivity Loss form for cost-effective analysis will be asked of the patient.
16079023|NCT02316275|Other|Standard post-operative activity restriction|
16079024|NCT02316262|Procedure|Targeted Muscle Reinnervation|Targeted reinnervation (TR) is a surgical procedure originally designed to provide intuitive control of upper limb prostheses through transfers of residual nerves to otherwise redundant target muscle. Native motor innervation of the target muscle is cut, and the residual nerves-after excision of end-neuromas-are coapted to the motor end point of the motor nerve, close to its point of entry into the muscle. The central principle underlying the nerve transfers in TR surgery is to reestablish the function of the amputated nerve and allow intuitive, seamless prosthesis control.
16079025|NCT02316249|Drug|Estradiol|Patients will be instructed to digitally apply 0.5mg of cream inside vagina every night for 2 weeks. After 2 weeks they will switch to 2 nights weekly.
16079026|NCT02316249|Other|placebo|Patients will be instructed to digitally apply 0.5mg of cream inside vagina every night for 2 weeks. After 2 weeks they will switch to 2 nights weekly.
16079027|NCT02316236|Drug|dexmedetomidine|an alpha-2 receptor agonist
16079028|NCT02316236|Other|loading dose|0.8ug/kg of dexmedetomidine is given in 10 minutes
16079029|NCT02316236|Other|sustaining dose|0.4ug/kg/min of dexmedetomidine is given
16079060|NCT02315924|Other|staged coronary and cerebral intervention|Staged strategy was intended that coronary or cerebral intervention will be performed within 7 days from the first procedure.
16079061|NCT02315911|Procedure|ATE|surgical removal of adenoids and tonsils
16079062|NCT02315911|Procedure|APP|surgical removal of adenoids and tonsils and suturing of palatal pillars
16079230|NCT02314650|Other|electrodes attached|electrode were attached to skin
16079030|NCT02316223|Behavioral|Supporting Asthma Management Behaviors in Aging Adults (SAMBA)|The SAMBA program will be led by an asthma care coach (ACC) and the home program by a community health worker (CHW). All interventions, including usual care, will include EMR-based asthma self-management and decision support tools for clinicians in all practice sites. The ACC and CHW will provide education, goal setting, and general self-management support with assigned patients and coordinate with PCPs through in-person and phone contacts over 12 months. Outcomes will be measured through interviews, EMR chart abstractions, and from the Statewide Planning and Research Cooperative System (SPARCS) dataset to identify all ED visits and hospitalizations to any New York State facility.
16079031|NCT02316210|Device|electrical stimulation|
16079032|NCT02316197|Drug|MSC2490484A (M3814)|Participants received MSC2490484A capsules at escalated dose from 100 mg to 400 mg orally from Day 1 to Day 21 of each treatment cycle until disease progression, unacceptable toxicity, withdrawal of consent, and/or occurrence of any criterion for withdrawal from study or M3814.
16079033|NCT02316184|Behavioral|Motivational Interviewing|Motivational Interviewing is a client-centered method of exploring individual's interest in making behavioral changes. In this study, the targeted behavior is alcohol use.
16079034|NCT02316184|Behavioral|Brief Advice|
16079035|NCT02316171|Biological|CVA21|CAVATAK is a purified preparation of CVA21
16079036|NCT02316171|Drug|Mitomycin C|Chemotherapy
16079037|NCT02316158|Other|Web-based support|Comparison between the efficacy between webb-based support and informational support
16079038|NCT02316145|Behavioral|Habilitation (Internet-based support and coaching)|Support and coaching with therapist (psychologist or educational therapist) by using chat and e-mail
16079039|NCT02316132|Drug|Stress|Corticotropin-Releasing Hormone
16079040|NCT02316132|Drug|Control|Saline 0.9%
16079041|NCT02316106|Drug|daratumumab|16 mg/kg administered by intravenous (IV) infusion once every week in Cycle 1, every other week in Cycle 2 and Cycle 3, every 4 weeks in Cycle 4 to Cycle 7, and from Cycle 8 to Cycle 20 on Day 1 of each cycle. If, as per investigator discretion, there is a positive benefit/risk ratio, absence of Grade greater than or equal to (>=) 3 treatment related toxicity, and at least stable disease has been achieved, treatment can be extended and given every 8 weeks after Cycle 20. For participants participating in treatment extension, the duration of infusion may be shortened to a 90-minute infusion or can switch to daratumumab 1800mg subcutaneous (Q8w).
16079042|NCT02316106|Drug|daratumumab|16 mg/kg administered by IV infusion once every week in Cycle 1, and then on Day 1 of each cycle from Cycle 2 to Cycle 20, and every 8 weeks after Cycle 20. If, as per investigator discretion, there is a positive benefit/risk ratio, absence of Grade greater than or equal to (>=) 3 treatment related toxicity, and at least stable disease has been achieved, treatment can be extended and given every 8 weeks after Cycle 20. For participants participating in treatment extension, the duration of infusion may be shortened to a 90-minute infusion or can switch to daratumumab 1800mg subcutaneous (Q8w).
16079043|NCT02316106|Drug|daratumumab|16 mg/kg administered by IV infusion once every week in Cycle 1 only. Treatment cycles are 8 weeks in length.
16079044|NCT02316093|Other|Procedure: Gingival Crevicular Fluid, Saliva and Blood Sampling|
16079045|NCT02316080|Other|Dental bleaching|Home-use or in-office dental bleaching was performed in patients that received different types od desensitizing therapy
16079046|NCT02316080|Other|Desensitizing therapy|Participants (in T1 and T2) used domestic-use (DU) or in office (IO) desensitizers (D): Control Group; (DU)- experimental dentifrice with 7,5% of Biosilicate micro-particles-(D1); Sensodyne® dentifrice-(D2); (DU)-Odontis RX Sensiblock® dentifrice-(D3); (IO)-Biosilicate micro-particles paste, 1:1-(D4); (IO)-bioglass type 45S5 paste, 1:1 (D6); (IO)-Desensebilize Nano P-(D6).
16079047|NCT02316067|Other|Rehabilitation|The CHORDATA® Method (16 sessions; 50 minutes each; twice a week) consisted of three exercises: (1) anterior pendulum, with the patient seated on a chair, upper limb suspended by springs and straps, and actively moving the trunk forward; (2) posterior pendulum exercise, on a similar position as exercise (1) but now moving the trunk backwards and recruiting the abdominal wall muscles during a posterior pelvic tilt motion; and (3) stand-up and sit-down exercise, patient with knees fixed anteriorly, initiating the standing-up movement by pulling back and down the springs, trying to maintain the standing position for as long as possible, balancing the trunk and transferring the supporting force from the upper limbs to the lower limbs.
16079048|NCT02316054|Device|MPHI|addictive value of MPHI to management of high risk cardiovascular type 2 diabetes
16079049|NCT02316041|Procedure|Small incision lenticule extraction|The VisuMax femtosecond laser is used to create two interfaces that define a refractive lenticule of stromal tissue and a 2mm wide tunnel to connect the upper layer to the corneal surface. The lenticule is manually dissected and removed through the small 2mm incision without the need to create a flap as in LASIK.
16079050|NCT02316041|Device|ReLEx® (SMILE)|
16079051|NCT02316028|Drug|Decitabine|"administration of decitabine by hepatic arterial infusion
~Accrual of patients and dosing of decitabine will be guided by a traditional 3+3 design using an accelerated titration for the first three dose levels.
~Proposed dose levels:
~10 mg/m2 per course
~15 mg/m2 per course
~20 mg/m2 per course"
16079052|NCT02316015|Dietary Supplement|Infatrini® or Infatrini Peptisorb®|
16079053|NCT02316002|Drug|Pembrolizumab|
16079054|NCT02315989|Radiation|proton therapy|proton therapy
16079055|NCT02315976|Drug|Propatyl Nitrate|Propatyl nitrate 10mg administered orally, three times daily
16079056|NCT02315963|Other|Performance Feedback|Performance Feedback regarding the patients efforts and accomplishments during the patients stay in the rehabilitation clinic, an expected average of 6 weeks. The data available about the patients progress will be analysed and processed to create a visual illustration shown to the patient on a daily bases.
16079057|NCT02315950|Other|Botulinum toxin and cineMRI-UDS|The investigators will be testing the capability of cineMRI combined with simultaneous urodynamics in the context of OAB in this proposal and expect to reveal a new understanding of diseased lower urinary tract physiology. Participants will receive an injection of intravesical botulinum toxin after filling out validated questionnaires and receiving a pre-treatment cineMRI-UDS.
16079058|NCT02315937|Procedure|transthoracic echocardiography|measurement of inferior vena cava diameter during inspiration and expiration using transthoracic echocardiography
16079059|NCT02315924|Other|simultaneous coronary and cerebral intervention|Simultaneous strategy is considered that coronary and cerebral intervention will be performed via the same access and within the same day.
16079064|NCT02315885|Other|Alcohol administration|
16079065|NCT02315872|Drug|ACTH|ACTH injections twice weekly for 28 weeks.
16079066|NCT02315872|Drug|Placebo|Placebo injections twice weekly for 28 weeks.
16079067|NCT02315833|Drug|Acetium|Capsule for oral administration contains L-cysteine 100mg
16079068|NCT02315833|Drug|Placebo|A placebo capsule matching Acetium for oral administration.
16079069|NCT02315820|Procedure|Induction of labor group (Group I)|Women at 38-40+3 weeks with estimated fetal weight 3800-4500 will be offered ripening and IOL.
16079070|NCT02315807|Device|transcranial direct current stimulation|
16079071|NCT02315794|Device|SPI®ART|implant prothetic restoration using a yttrium oxide stabilized zirconia abutment
16079072|NCT02315794|Device|SPI®EASY|implant prosthetic restoration using a commercially pure titanium grade 4 abutment
16079073|NCT02315781|Device|active tDCS|transcranial direct current stimulation (tDCS), is a type of electrical stimulation for the brain
16079074|NCT02315781|Device|Sham tDCS|Sham tDCS will appear exactly the same as active tDCS, but no stimulation will be administered.
16079075|NCT02315768|Drug|GA101|
16079076|NCT02315768|Drug|ibrutinib|
16079077|NCT02315742|Behavioral|Let's Move Program|Patients will walk 5 times per week for 12 weeks for a minimum of 30 minutes while using a heart rate monitor. After the first two weeks of walking, patients will attend four consecutive group meetings which a research team member will look at walking logs and download data from heart rate monitor to focus on progress. Patient will receive weekly phone calls to monitor progress and to change walking duration or intensity level.
16079078|NCT02315716|Procedure|Autologous Stem Cell Transplant (ASCT)|Randomisation to melphalan conditioned autologous stem cell transplant
16079079|NCT02315716|Drug|Consolidation with 4 cycles of CarCyDex|Randomisation to 4 further cycles of Carfilzomib, Cyclophosphamide and Dexamethasone for responding patients following 4 cycles of induction chemotherapy
16079085|NCT02315690|Drug|dihydroartemisinin-piperaquine (DHAp)|In the fMDA arm, all individuals in the target area will receive dihydroartemisinin-piperaquine (DHAp) once daily for 3 days with the first dose taken no later than 5 weeks from the index case presentation (goal within one week).
16079086|NCT02315690|Procedure|reactive case detection|Individuals in RACD target areas will be tested by RDT and if positive will be taken to the nearest health facility for treatment as per program operating procedures.
16079087|NCT02315677|Device|Nasal Intubation with nasal RAE endotracheal tube|A single experienced operator with at least 5 years of clinical anesthetic experience will intubate using the standard nasal RAE endotracheal tube with bevel facing leftward.
16079088|NCT02315677|Device|Nasal Intubation with Parker Flex-Tip endotracheal tube|A single experienced operator with at least 5 years of clinical anesthetic experience will intubate using the Parker Flex-Tip endotracheal tube with the bevel facing posteriorly.
16079089|NCT02315664|Behavioral|Education session, Fitbit Flex, and remote coaching by a PT|Participants will receive a brief education session, use of a commercially available physical activity tracker called Fitbit Flex, and remote counseling by a PT. Intervention will be received immediately.
16079090|NCT02315664|Behavioral|Same intervention with a 2 month delay|The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 2 month delay.
16079091|NCT02315651|Dietary Supplement|Coenzyme Q10|A snack containing 60 mg of Coenzyme Q10. The snack contains also dried fruits and nuts, and their content are identical to this of placebo.
16079092|NCT02315651|Dietary Supplement|Placebo|A snack identical to the trial snack, but without Coenzyme Q10. The snack contains also dried fruits and nuts.
16079093|NCT02315625|Drug|Sunitinib|37.5 mg once daily will continue until progression or unacceptable treatment-related toxicity
16079094|NCT02315625|Drug|Everolimus|10 mg daily will continue until progression or unacceptable treatment-related toxicity
16079096|NCT02315573|Procedure|Wrist block anesthesia|The carpal tunnel release surgery will be performed under wrist block anesthesia. Group 1 will have the wrist block performed with Lidocaine and epinephrine, while Group 2 with Bupivacaine and epinephrine.
16079097|NCT02315560|Device|TRANSCUTANEOUS ELECTRICAL NERVE STIMULATOR (TENS|electrical stimulation of the nerves in the foot on the incidence of nocturnal enuresis (bedwetting) in children
16079132|NCT02315326|Drug|procarbazine|Arm D: THIS IS THE ONLY ARM RECRUITING: : Oral procarbazine (100mg/m2/day) will be given on Day 1 through 7 during each cycle. Patients will be maintained on a tyramine-free diet during procarbazine administration.
16079133|NCT02315300|Device|medilog® DARWIN FD12|
16079134|NCT02315300|Device|Continuous Glucose Monitoring|
16079135|NCT02315287|Drug|Pioglitazone|Comparison of two different thiazolidinediones
16079136|NCT02315287|Drug|Lobeglitazone|Comparison of two different thiazolidinediones
16079137|NCT02315274|Other|Frequent remote contact between clinic visits.|Subjects will upload diabetes device data onto websites. Website data will be reviewed by study team who will provide feedback to patients without clinic visits.
16079098|NCT02315547|Drug|Antibiotics|Patients will be given antibiotics based on sputum microbiology during steady-state bronchiectasis. The methodology has been described in the British Thoracic Society guideline [16]. Briefly, for first-line therapy, patients isolated with Hemophilus influenzae, Hemophilus parainfluenzae, Streptoccus pneumoniae and Moraxella catarrhalis at baseline will be treated with amoxicillin clavulanate potassium (625mg bid); patients isolated with Klebsela pneumonae or Pseudomonas aeruginosa at baseline will be treated with fluoroquinolones. Levofloxacin (500mg qd) will be empirically employed for antibiotic treatment in those who tested negative to sputum microbiology. Severe BEs could be prescribed with intravenous antibiotics therapy at the discretion of study investigators, either in the out-patient department or hospitalized for intensive systemic treatment. Hospitalized patients will not be included in the exacerbation cohort.
16079099|NCT02315534|Drug|BBI608|"In arm A, BBI608 will be administered at the recommended Phase 2 dose (RP2D) twice daily for 7(±2) days prior to planned surgical resection or biopsy of recurrent GBM. Upon the clinical recovery of the patient and at a time between 15-28 days after surgery, BBI608 will be administered orally, daily, each day of a 28 day cycle in combination with temozolomide.
~In arm B, patients who are not candidates for surgical resection will receive BBI608 administered orally, daily, each day of a 28 day cycle at the RP2D in combination with temozolomide."
16079100|NCT02315534|Drug|Temozolomide|Temozolomide (TMZ) will be administered orally, once daily, at a dose of 150 mg/m^2 daily on days 1 through 5 of each 28-day study cycle. The dose of temozolomide can be increased to 200 mg/m^2 as per standard TMZ dosing guidelines for patients who complete at least one cycle at 150 mg/m^2.
16079101|NCT02315521|Procedure|Fetal Intervention for LUTO|"Fetal vesico-amniotic shunting placement consists in placing a shunt (stent) percutaneously from fetal bladder to the amniotic cavity under ultrasound guidance.
~Fetal cystoscopy will be performed using a thin scope that will be introduced to the fetal bladder for evaluation of the cause of the obstruction and ablation of the posterior urethral valves."
16079102|NCT02315508|Drug|AUT00063|800 mg orally, once a day, for 4 weeks
16079103|NCT02315508|Drug|Placebo|orally, once a day, for 4 weeks
16079104|NCT02315495|Drug|Saxagliptin|
16079105|NCT02315495|Drug|Acarbose|
16079106|NCT02315482|Procedure|pneumoperitoneum insufflation and steep trendelenburg|the sequence of pneumoperitoneum insufflation and steep trendelenburg positioning is randomized
16079107|NCT02315469|Other|Comprehensive Geriatric Assessment|Complete pre-operative geriatric assessment
16079108|NCT02315469|Other|Questionnaire Administration|Ancillary studies
16079109|NCT02315456|Procedure|capsulorhexis|
16079110|NCT02315443|Drug|NA-1|
16079111|NCT02315443|Drug|Placebo|
16079112|NCT02315430|Drug|Cabozantinib S-malate|Given PO
16079113|NCT02315430|Other|Laboratory Biomarker Analysis|Optional correlative studies
16079114|NCT02315417|Drug|gevokizumab|
16079115|NCT02315417|Drug|Placebo|
16079116|NCT02315417|Drug|gevokizumab open-label|
16079117|NCT02315404|Procedure|CAP|CAP fitted to the end of the endoscope
16079118|NCT02315391|Dietary Supplement|isolated whey protein|isolated whey protein
16079119|NCT02315391|Dietary Supplement|micellar whey protein|micellar whey protein
16079120|NCT02315391|Dietary Supplement|glycine|glycine
16079121|NCT02315391|Dietary Supplement|citrulline|citrulline
16079122|NCT02315378|Behavioral|TAU|Treatment as Usual for patients presenting after accidents and assaults as it pertains to mental health, is a brief intervention that varies in length depending on the patient's needs. If the patient is highly distressed, the social worked will provide brief crisis management support. The social worker also performs case management functions such as attempting to get in touch with family, contacting shelter or hotel if the patient is homeless, contacting other social service agencies if needed, and providing the patient referrals for mental health services in the community. A psychiatrist will also be called to assess the patient only if he or she appears to be a threat to self (suicidal) or others, and exclusion criteria for this study.
16079123|NCT02315378|Behavioral|ARTAT|A one-session intervention targeting at-risk individuals (those continuing to experience peritraumatic panic following a trauma) and designed to reduce peritraumatic anxiety and enhance self-efficacy.
16079124|NCT02315352|Drug|L-PZQ ODT|L-PZQ ODT (MSC2499550A) tablet at a dose of 150 milligram (mg) put and disintegrated in the mouth without water
16079125|NCT02315352|Drug|Rac-PZQ ODT|Rac-PZQ ODT (MSC1028703A) tablet at a dose of 150 mg put and disintegrated in the mouth without water
16079126|NCT02315352|Drug|L-PZQ ODT|L-PZQ (MSC2499550A) tablet at a dose of 150 mg dispersed in water
16079127|NCT02315352|Drug|Rac-PZQ ODT|Rac-PZQ ODT (MSC1028703A) tablet at a dose of 150 mg dispersed in water
16079128|NCT02315352|Drug|Cesol®|Cesol® tablet at a dose of 150 mg crushed in water
16079129|NCT02315326|Drug|Ibrutinib|"Arm A: Ibrutinib will be given once daily. The starting dose cohort (level 1) will receive 560 mg/day (4 x 140 mg capsules). During the dose escalation period of the study, the 3+3 design will be applied (see Table 3). Participants will be assigned to cohorts of increasing oral daily doses of ibrutinib (560mg, 840mg) until disease progression, intolerable toxicity or death. Three patients with recurrent/refractory PCNSL or recurrent/refractory SCNSL will be treated with daily oral ibrutinib for a 28-day cycle starting at dose level 1 and observed for toxicities during cycle 1. Arm B: Ibrutinib will be given at the MTD defined in Arm A."
16079130|NCT02315326|Drug|HD- Methotrexate (MTX)|Arm C1: HD-MTX at 3.5g/m2 (standard hydration/leucovorin support) will be given on day 1 and 15 of each 28-day cycle for a total of 4 cycles totaling 8 HD-MTX administrations. Ibrutinib will be given between days 5 and 14 as well as days 19 and 28 of each cycle and continued daily after completion of HD-MTX treatments.The starting dose of ibrutinib is 560 mg/day (4x140mg capsules)
16079131|NCT02315326|Drug|Rituximab + HD- Methotrexate (MTX)|Arm C2: Intravenous rituximab (500mg/m2) will be given on day 0, 14, and 28 of cycle 1 and day 14 and 28 of all following cycles. HD-MTX at 3.5g/m2 (standard hydration/leucovorin support) will be given on day 1 and 15 of each 28-day cycle for a maximum of 4 cycles totaling 8 HD-MTX administrations. Ibrutinib will be given between days 5 and 14 as well as days 19 and 28 of each cycle and continued daily after completion of HD-MTX treatments. The starting dose of ibrutinib is 560 mg/day (4x140mg capsules; dose level 1) (see Table 4). Filgrastim will be given at days 7-11 and 22-26.
16079181|NCT02315001|Other|Placebo|Volume-matched normal saline placebo administered via subcutaneous injection
16079231|NCT02314637|Drug|Teneligliptin|Teneligliptin for 52 weeks
16079138|NCT02315261|Procedure|Elective Thoracic and Abdominal Surgery Patients|This is an observational audit, reviewing the implementation of a standard care practice and requiring de-identified data collection in Elective Thoracic and Abdominal Surgery Patients only. All collected data will be that which is routinely part of normal clinical practice. The Research staff will systematically collect data on each patient. Some information can be obtained from the medical record, intraoperative anesthetic record, acute pain service record, etc whereas other information has to be obtained from direct observation at the bedside.
16079139|NCT02315248|Radiation|Quantitative computed tomography scan for bone density analysis|A low radiation dose quantitative computed tomography (QCT) of the spine (L1 and L2) and the hips will be performed to measure bone density in the spine and hips.
16079140|NCT02315235|Biological|Normal saline|Normal saline is injected in one leg of patient.
16079141|NCT02315235|Biological|stem-cell|"Granulocyte colony-stimulating factor (G-CSF) is injected into subcutaneous for three days prior to the blood collection (D-3 to D-1). Peripheral mononuclear stem-cell is collected by Cobe spectra apheresis system in D-day.
~The stem-cell (mononuclear cell) is injected into the muscle in the other side leg of patient."
16079142|NCT02315222|Dietary Supplement|Regenium|
16079143|NCT02315222|Dietary Supplement|Placebo|
16079144|NCT02315222|Procedure|Full Mouth Disinfection|
16079145|NCT02315209|Device|UHS, UPP, Comfort Plug|only Repairs with 3D Devices (UPP,UHS,Comfort Plug)
16079146|NCT02315196|Drug|pegylated liposomal doxorubicin hydrochloride|Given IV
16079147|NCT02315196|Drug|epirubicin hydrochloride|Given IV
16079148|NCT02315196|Drug|carboplatin|Given IV
16079149|NCT02315196|Procedure|therapeutic conventional surgery|Undergo definitive surgery
16079150|NCT02315196|Drug|paclitaxel|Given IV
16079151|NCT02315196|Other|laboratory biomarker analysis|Correlative studies
16079152|NCT02315196|Other|quality-of-life assessment|Ancillary studies
16079153|NCT02315183|Other|This is an observational Study|THis study has no intervention
16079154|NCT02315170|Device|intraocular injection guide|The device is 35mm long with tapered edges for an easy grip and it aligns with the curvature of the cornea to ensure that needle entry takes place at the optimal distance for injection
16079155|NCT02315170|Device|standard lid speculum|standard wire lid speculum
16079156|NCT02315157|Drug|Bendamustine|Given IV
16079157|NCT02315144|Drug|TV48108|TV48108 15, 60, 120 μg
16079158|NCT02315144|Drug|Placebo|Placebo Comparator
16079159|NCT02315131|Drug|TV46017|TV46017 15, 60, 120, and 240 μg; 4 ascending doses of inhaled TV46017 with an ipratropium bromide reference to evaluate the single administration of 4 ascending doses of inhaled TV46017 in COPD patients.
16079160|NCT02315131|Drug|Placebo|Placebo Comparator
16079161|NCT02315118|Drug|T-cell therapy + Rituximab + IL-2|"T cells collection
~T cells expansion and modification in the laboratory
~T cells infusion back to the patients"
16079162|NCT02315105|Procedure|Laparoscopic Greater Curvature Plication|LGCP is a procedure in which the stomach is folded inwards to that its capacity to hold amount of food is decreased dramatically. This is done under general anesthesia. The operation takes about 1 hour and is done laparoscopically. The attachments of the stomach to the spleen are feed up and the outside is folded inside and stitched up to keep it from folding in. To ensure that the surgeon has not obstructed the passage in or out of the stomach, a tube ( Bougie) is placed in the stomach at the time of the creation of the fold and checked again at the end of the procedure with a camera in the stomach which is placed through the mouth (EGD- upper endoscopy) to ensure the desired outcome is achieved.
16079163|NCT02315092|Device|Fluorescence Imaging|Wounds will be imaged using violet light (405 nm) illumination to locate areas with bacterial presence to guide swabbing.
16079164|NCT02315079|Other|Eye inflammation|This group will have a regular eye exam with the collection of tears. In addition, a the Ocular Surface Disability Index Survey of National Eye Institute Visual Functioning Questionnaire- 25 may be administered.
16079165|NCT02315079|Other|Without eye inflammation|This group will have a regular eye exam with the collection of tears.
16079166|NCT02315066|Drug|PF-04518600|Part A1 - PF-04518600 will be administered intravenously every 14 days in cohorts of 2 or more patients starting at a dose of 0.01 mg/kg. Increases in dose will continue until MTD is determined
16079167|NCT02315066|Drug|PF-04518600|Part A2 - patients with hepatocellular carcinoma will be randomized to receive treatment with PF-04518600 at various doses administered intravenously
16079168|NCT02315066|Drug|PF-04518600 plus PF-05082566|Part B1 -In cohorts of 2 or more patients, PF-04518600 will be administered intravenously every 2 weeks starting at a dose of 0.1 mg/kg and PF-05082566 will be administered intravenously 4 weeks starting at a dose of 20 mg. Increases in dose will continue until MTD is determined.
16079169|NCT02315066|Drug|PF-04518600 plus PF-05082566|Part B2 - patients with select tumor types (ocular melanoma, cutaneous/acral melanoma or non-small cell lung cancer) will be treated at dose levels based on the OBD selected in Part 1.
16079170|NCT02315053|Other|Low dose FDG PET/CT 5 x.|Multiple FDG PET/CT studies will be added to the normal diagnostic procedures as a part of this study, with the number of scans depending on the study stage, to a maximum of 6 per patient.
16079171|NCT02315040|Device|EVIE|EVIE is a small, mechanical, single use pump that mimics natural fertilization by introducing sperm into the uterus over a period of 4 hours, rather than all at once as in conventional IUI
16079172|NCT02315040|Other|Standard Intrauterine Insemination|standard intrauterine insemination procedure
16079173|NCT02315027|Biological|Autologous Mesenchymal Stem Cells|single dose of 1 × 10(7) cells intrathecally
16079174|NCT02315027|Biological|Autologous Mesenchymal Stem Cells|2 doses of 5 × 10(7) cells intrathecally each 1 month (±4 days) apart
16079175|NCT02315027|Biological|Autologous Mesenchymal Stem Cells|2 doses of 1 × 10(8) cells intrathecally each 1 month apart
16079176|NCT02315027|Biological|Autologous Mesenchymal Stem Cells|Ten doses of 5 x 10(7) (±20%) cells intrathecally six months (±1 month) apart
16079177|NCT02315027|Biological|Autologous Mesenchymal Stem Cells|Ten doses of 2.5 x 10(7) (±20%) cells intrathecally six months (±1 month) apart
16079178|NCT02315014|Other|whey protein|whey protein.
16079179|NCT02315014|Other|placebo|placebo.
16079180|NCT02315001|Drug|Liraglutide|GLP-1 receptor agonist administered via subcutaneous injection
16079271|NCT02314364|Radiation|SBRT with protons or photons|
16079182|NCT02314988|Drug|Tranexamic Acid|"3.0 grams of tranexamic acid will be poured in the surgical field and left in contact for five minutes. Subsequently, excess study solution will be suctioned away without touching the surrounding tissue surfaces and then the would closed without irrigation or manipulation.
~TXA solution will be prepared using a dose of 3 grams of tranexamic acid combined with 70 mL of sterile normal saline, for a total volume of 100 mL."
16079183|NCT02314988|Drug|Placebo|"Placebo will be poured in the surgical field and left in contact for five minutes. Subsequently, excess solution will be suctioned away without touching the surrounding tissue surfaces and then the would closed without irrigation or manipulation.
~The placebo solution will be 100 mL of sterile normal saline."
16079184|NCT02314975|Device|AcceleDent vibrational device|Supplementary vibrational force with fixed appliances
16079185|NCT02314975|Device|Sham AcceleDent device|Supplementary sham-vibrational device with fixed appliances
16079186|NCT02314975|Other|Fixed appliance only|Fixed appliance treatment only
16079187|NCT02314949|Procedure|intestinal transplantation|
16079188|NCT02314936|Dietary Supplement|Litesse powder containing 12 g polydextrose|12 g polydextrose
16079189|NCT02314936|Dietary Supplement|Litesse powder containing 8 g polydextrose|8 g polydextrose, 4 g maltodextrin
16079190|NCT02314936|Dietary Supplement|Litesse powder containing 4 g polydextrose|4 g polydextrose, 8 g maltodextrin
16079191|NCT02314936|Dietary Supplement|Placebo|12 g Maltodextrin
16079192|NCT02314923|Biological|V920 Vaccine|Vesicular Stomatitis Virus (VSV)-based vaccine 1-mL injection containing 3x10^3, 3x10^4, 3x10^5, 3x10^6, 9x10^6, 2x10^7, or 1x10^8 pfu.
16079193|NCT02314923|Other|Placebo|0.9% Saline
16079194|NCT02314910|Other|Sample histology|
16079195|NCT02314897|Device|LV pacing|Left ventricular pacing lead implanted via the coronary sinus.
16079196|NCT02314897|Device|RV pacing|Conventional right ventricular pacing.
16079197|NCT02314884|Drug|Cafusertib Hydrochloride|
16079198|NCT02314871|Other|Epidural analgesia|see Arm/group description
16079199|NCT02314871|Drug|Piritramide|see Arm/group description
16079200|NCT02314871|Drug|Morphine|see Arm/group description
16079201|NCT02314858|Behavioral|Brief Personalized Video (BPV)|The BPV group will view a portion of their own sleep study that took place during their overnight sleep study.
16079202|NCT02314858|Behavioral|Non-Personalized Video (NPV)|The NPV group will see a stock video of someone with OSA.
16079203|NCT02314858|Behavioral|Treatment as Usual (TAU)|The TAU group will not watch a video.
16079204|NCT02314845|Other|Optimal PEEP|"Optimal PEEP determined by EIT during a PEEP titration procedure."
16079205|NCT02314845|Other|Low PEEP|Use of PEEP of 4 cmH2O during intraoperative period
16079206|NCT02314832|Procedure|adductor canal block|ultrasound guided saphenous nerve block in the adductor canal
16079207|NCT02314832|Procedure|femoral nerve block|ultrasound guided femoral nerve block
16079208|NCT02314819|Drug|fruquintinib|fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off
16079209|NCT02314819|Drug|placebo|fruquintinib placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off
16079210|NCT02314806|Drug|Irrigation with gentamicin solution|The surgical bed is irrigated with a gentamicin solution
16079211|NCT02314806|Drug|Irrigation with Clindamycin solution|The surgical bed is irrigated with a clindamycin solution
16079212|NCT02314806|Drug|Irrigation with Normal saline|The surgical bed is irrigated with normal saline
16079213|NCT02314793|Drug|ASP2205|oral
16079214|NCT02314793|Drug|Placebo|oral
16079215|NCT02314780|Drug|Heme arginate 3mg/kg|
16079216|NCT02314780|Drug|Heme arginate 1mg/kg|
16079217|NCT02314780|Drug|Placebo|
16079218|NCT02314767|Behavioral|Interpersonal Psychotherapy|Patients were treated with IPT method, which was an active comparator vs treatment as usual
16079219|NCT02314767|Behavioral|Psychoeducational Group Therapy|Patients were treated with PeGt method which was an active comparatos vs treatment as usual
16079220|NCT02314754|Drug|Mifepristone followed by misoprostol 24-48 hours later|200mg oral mifepristone and 800mcg buccal misoprostol 24-48 hours after mifepristone
16079221|NCT02314741|Procedure|POEM Procedure|The procedure is performed under anesthesia.The procedure involves endoscopic electrosurgical dissection with an Olympus triangular tip knife.The myotomy is usually ~6cm long & averages 8-10cm. After the myotomy is performed the scope is withdrawn & inserted into the lumen to inspect the mucosa, ensure mucosal integrity & confirm easy passage of the endoscope through the LES consistent with an adequate myotomy. The mucosal entry site is usually 2-3cm long, & is closed with 5-10 endoscopic clips. Patients are hospitalized after procedure for observation.The patient is given IV-nutrition until post-operative day 1. An esophagram is obtained. If no loss of mucosal integrity or leak is noted, a liquid diet is started, which is continued for several days before initiating a solid diet.
16079222|NCT02314728|Drug|Misoprostol|Patients who are randomized to receive misoprostol will have 25mcg placed vaginally. Repeated dosing of misoprostol is based on clinical exam and clinical judgment of the provider.
16079223|NCT02314728|Drug|Oxytocin|Patients who are randomized to receive oxytocin alone will receive intravenous administration of oxytocin as designated by the hospital protocol. Protocol begins with 2 milliunits of oxytocin that is then titrated over time. Titration is based on clinical exam and clinical judgment of the provider and is continued until there are adequate uterine contractions.
16079224|NCT02314702|Device|PROFEMUR® L Revision Femoral Stem|Revision Total Hip Arthroplasty
16079225|NCT02314689|Drug|Intravenous (IV) citrulline|
16079226|NCT02314676|Biological|PEG-somatropin|
16079227|NCT02314663|Device|"COMBINED STRATEGY"|"Participants in the intervention group will be supplied with: a) printed matter containing information on the disease and its management (this will be handed out at each of the follow-up visits); b) mobile-telephone text messages containing guideline summaries, reminders of forthcoming appointments and/or arrangements for making new appointments in the event of non-attendance (in the periods between visits); and, c) self-report cards to check compliance with recommendations (across the entire follow-up)."
16079228|NCT02314650|Other|acupoint stimulation|stimulation was given at acupoints
16079229|NCT02314650|Other|non-acupoint stimulation|stimulation was given at non-acupoints
16079232|NCT02314637|Drug|Teneligliptin + Sulfonylurea|Teneligliptin for 52 weeks in combination with sulfonylurea
16079233|NCT02314624|Behavioral|Behavioral Activation for Depression, Cognitive Behavior Therapy for Insomnia, Collaborative Assessment and Management of Suicidality|Evidence-based interventions for treating depression and concurrent problems
16079234|NCT02314624|Behavioral|Care-as-Usual Psychotherapy|Usual care psychotherapy for depression and concurrent problems
16079235|NCT02314611|Device|PROFEMUR® Gladiator HA Coated Modular Femoral Stem|Total Hip Arthroplasty (THA) using PROFEMUR® Gladiator HA Coated Modular Femoral Stem
16079236|NCT02314598|Other|No treatment|
16079237|NCT02314585|Other|Exercise|Participants will partake in three, six month phases. In the second phase, either an education or exercise program will be implemented. Assessments will follow each phase with the addition of an initial assessment for baseline data.
16079238|NCT02314585|Other|Education|Participants will partake in three, six month phases. In the second phase, either an education or exercise program will be implemented. Assessments will follow each phase with the addition of an initial assessment for baseline data.
16079239|NCT02314572|Device|Binocular cataract surgery with phacoemulsification and implantation of multifocal intraocular lenses|Binocular implantation of the combination of AcrySof® IQ ReSTOR® multifocal intraocular lenses with an addition of +2.5 D in the distance-dominant eye and +3.0 D in the fellow eye.
16079240|NCT02314559|Drug|Manual titration of propofol|One group will be sedated with a manual titration technique: here the titration of propofol is done manually by the anesthetist. Dosages may range between 50 and 400mg, given by boluses of 20-50mg.
16079241|NCT02314559|Drug|Target controlled infusion of propofol|The other group will be sedated with a target controlled infusion technique (pump, marsh or Schneider). The anesthetist can titrate indirectly by adjusting the target controlled infusion to achieve adequate sedation. The concentrations of propofol may vary between 2 and 6 µg/ml, achieved by increments of 0.5-1.5 µg/ml.
16079242|NCT02314546|Drug|Midazolam|"Study participants will be randomly assigned to one of three treatment groups:
~Group 1 - Placebo - Control patients will receive intranasal saline.
~Group 2 - Nasal Midazolam Only - Patients will receive 0.2 mg/kg of intranasal midazolam.
~Group 3 - Midazolam Plus Xylocaine - Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam."
16079243|NCT02314546|Drug|xylocaine|Midazolam Plus Xylocaine - Patients will receive 0.2 mg/kg intranasal midazolam plus xylocaine 4% in a dose based on 25% of the volume of the midazolam.
16079244|NCT02314546|Drug|saline placebo|Placebo - Control patients will receive intranasal saline.
16079245|NCT02314533|Drug|fenofibrate|Fenofibrate (Lipanthyl®) 200mg capsule will be administered orally with breakfast once daily
16079246|NCT02314520|Device|peripherally inserted central catheter|Any complication associated with central access
16079247|NCT02314520|Device|centrally inserted central catheter|Central access not associated with any complication
16079248|NCT02314507|Other|Gua sha|A smooth, rounded-edged Gua sha tool will be press-stroked into the flesh enough to contact the fascial layer start at the midline of the subject's back. A stroke line is typically 4 to 6 inches long. Press-stroking will be repeated in one direction until the petechiae raises on that stroke line, typically 8 to 12 strokes. Gua sha will then be continued at the next stroke line directly adjacent to the one before, until the area covered the lower one third of the back.
16079249|NCT02314507|Other|Hot pack|A hydrocollator pack will be used and it will be stored at 42-43oC in the hydrocollator. 6 layers of towel will be used to cover the hydrocollator pack when applying to the back of the subjects.
16079250|NCT02314494|Behavioral|ProAsk|The intervention is a computer programme ProActive Assessment of Overweight Risk to identify infants at risk of developing childhood overweight and obesity. Parents of infants identified as at risk will be offered strategies for prevention by UK health visitors (public health nurses)
16079251|NCT02314481|Drug|MPDL3280A|Intravenous (IV) infusion, as monotherapy of in combination with chemotherapy
16079252|NCT02314481|Drug|Vemurafenib|Film coated tablet
16079253|NCT02314481|Drug|Alectinib|capsule
16079254|NCT02314481|Drug|Trastuzumab emtansine|Powder for concentrate for solution for infusion
16079255|NCT02314468|Procedure|Negative pressure wound therapy|NPWT changed twice a week.
16079256|NCT02314468|Procedure|Glycerol Preserved Allografts (GPA)|GPA changed every 7 to 10 days.
16079257|NCT02314455|Other|D-xylose|There will be four patient groups analyzed. Ten patients each, 10 with active eosinophilic esophagitis defined by consensus guidelines, 20 patients in histologic remission (10 by steroids and 10 by diet) and 10 control volunteers will be studied. Patients who have consented to the trial will be scheduled at the Clinical Research Unit (CRU) Patients will report to Charlton 7 the CRU, having their height, weight, blood pressure and temperature recorded. Subjects can choose to either have a saline lock IV placed or have their bloods drawn 3 separate times. They will receive 25 grams of D-xylose orally. The D-xylose will be mixed in 10 cc of water with 2 teaspoons of honey. D-xylose serum levels will be drawn at 5 and 10 and 60 minutes.
16079258|NCT02314442|Drug|ALN-PCSSC|Single or multiple doses of ALN-PCSSC by subcutaneous (sc) injection
16079259|NCT02314442|Drug|Sterile Normal Saline (0.9% NaCl)|calculated volume to match active comparator
16079260|NCT02314429|Device|Vaginal ring releasing lactic acid (racemic mixture)|
16079261|NCT02314416|Biological|Amniotic Stem Cells and Collagen Matrix|Nucel will be applied in between two pieces of collagen matrix'. The NuCel-impregnated collagen matrix will be placed over a clean, debrided wound.
16079268|NCT02314390|Behavioral|Group-Mindfulness-Based Cognitive Therapy|The intervention consists of 8 weekly sessions of MBCT. Each session will be administered in a group and will last 2 1/2 hours.
16079269|NCT02314390|Behavioral|Individual-Mindfulness-Based Cognitive Therapy|The intervention consists of 8 weekly sessions of MBCT. Each session will be administered individually and will last 45 to 60 minutes.
16079270|NCT02314377|Drug|Bevacizumab|Bevacizumab dosing of 5mg/kg q 2 weeks for 12 weeks (2.5 mg/week).
16079272|NCT02314351|Drug|Metoclopramide 10 mg|Intravenous form of metoclopramide is in the same appearance with placebo
16079273|NCT02314351|Drug|Placebo|Intravenous form of metoclopramide is in the same appearance with placebo
16079274|NCT02314351|Drug|Fentanyl|Intravenous fentanyl (1 mcg/kg), if pain persists at 30th minute
16079275|NCT02314338|Other|Pulmonary rehabilitation|In-patient pulmonary rehabilitation including individualized exercise prescription, group based exercise training, education, individual sessions with a multi professional health care team
16079276|NCT02314325|Drug|ADVATE [Antihemophilic Factor (Recombinant)]|In Arm 1 prior patients will be dosed as per body weight 20-40 IU/kg 5-7 infusions per fortnight
16079277|NCT02314325|Drug|ADVATE [Antihemophilic Factor (Recombinant)]|In Arm 2 patients who have completed arm 1 will cross over onto an individualised PK tailored alternate day dosing regimen
16079278|NCT02314312|Drug|Everolimus + low dose cyclosporin A + prednisolone|
16079279|NCT02314312|Drug|Standard immunosupressive regimen|
16079280|NCT02314299|Drug|MTP-131|
16079281|NCT02314286|Drug|Rosuvastatin|Rosuvastatin is a hydrophilic statin, short treatment (hours to days) with this type of statin improved the outcome of patients during acute myocardial infarction, sepsis, contrast-induced nephropathy, hepatic ischemia/reperfusion injury, emphasizing its preferential pleiotropic effects. Currently, the FDA classiﬁes all statins as pregnancy category X and discourages their use during pregnancy due to higher abortion rate and teratogenicity that were observed in animals exposed to hydrophobic statins during pregnancy. Since the use of statins after delivery is allowed, the present study will aim to evaluate whether Rosuvastatin may accelerates preeclampsia resolution following delivery and potentially reduce postpartum preeclampsia complications.
16079282|NCT02314286|Drug|Placebo|
16079283|NCT02314273|Drug|rhIL-11|patients receive rhIL-11(50 mcg/kg，subcutaneously)after standard chemotherapy，once a day for 10 days or until platelet count ≥80000/mL
16079284|NCT02314260|Other|bishop score calculation|Assessment of bishop score by vaginal examination
16079285|NCT02314260|Other|Trans-vaginal ultrasound|trans-vaginal ultrasound assessment of cervical length.
16079286|NCT02314260|Other|Modified bishop score calculation|using the cervical length and the original bishop score to calculate modified bishop score
16079287|NCT02314260|Procedure|labour induction|Induction of labor was carried out as per our hospital's standard protocol.
16079288|NCT02314247|Drug|Selinexor|"20 mg oral tablets: 60 mg dose on Days 1 and 3 of Weeks 1-4 of each 4-week cycle (Protocol V.3.0).
~20 mg oral tablets: 60 mg dose on Days 1 and 3 of Weeks 1-3 of each 4-week cycle (Protocol V.<3.0).
~Number of Cycles: up to 12 but there is no maximal duration for treatment."
16079289|NCT02314234|Drug|sugammadex (Bridion)|single dose of sugammadex at skin incision
16079290|NCT02314221|Device|Exoskeletal-assisted walking (ReWalk, Ekso)|The WALK arm will consist of supervised exoskeletal-assisted walking training, three sessions per week (4-6 h/week) for 36 sessions (12 weeks) and usual activities for their second 12-week period.
16079291|NCT02314208|Drug|Xenbilox|
16079292|NCT02314208|Dietary Supplement|Resveratrol|
16079293|NCT02314208|Drug|Tahor|
16079294|NCT02314195|Drug|Selective serotonin re-uptake inhibitor|A medication of selective serotonin re-uptake inhibitor (SSRI) family, Behavioral. The type and dosage of the medication was decided by the treating psychiatrist.
16079295|NCT02314195|Behavioral|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy for obsessive compulsive disorder carried out by a psychologist.
16079296|NCT02314195|Other|Music therapy|12 sessions of 30-minute individual-based receptive music therapy, supervised by the treating psychiatrist.
16079297|NCT02314182|Procedure|Primary tumor resection + chemotherapy|"Step 1: Primary Tumor (PT) resection
~Within 3 weeks after randomization
~Immunonutrition given 7 days prior to PT resection
~Mechanical bowel preparation performed before surgery according to the local practices
~Performed by laparoscopy (recommended) or by laparotomy (at the investigator's discretion)
~Step 2: postoperative CT-scan
~Must be performed within 4 weeks after surgery
~CT-scan/MRI with the same criteria as pre-treatment evaluation
~Step 3: Chemotherapy +/- target therapy
~Within 4 weeks after the surgery
~Chemotherapy administered according to the usual scheme for the chosen protocol
~All validated and/or registered perioperative rectal cancer treatments authorized
~The duration of one treatment cycle depending on the type of treatment administered
~Radiotherapy is allowed after randomization if indicated"
16079298|NCT02314182|Drug|Oxaliplatin/irinotecan + capecitabine, 5-FUI ± bevacizumab|"Treatment will start within 3 weeks after randomization; Chemotherapy will be administered according to the regimen in the chosen protocol and validated by the MDOC of each center.
~If complications occur, emergency surgery can be performed according to the local practices of each investigator center.
~Radiotherapy is allowed after randomization if indicated (MDOC)."
16079301|NCT02314156|Drug|Telapristone Acetate|Given transdermally
16079302|NCT02314156|Other|Placebo|Given PO
16079303|NCT02314156|Drug|Telapristone Acetate|Given PO
16079304|NCT02314156|Other|Placebo|Given transdermally
16079305|NCT02314156|Other|Laboratory Biomarker Analysis|Correlative studies
16079306|NCT02314156|Other|Questionnaire Administration|Ancillary studies
16079307|NCT02314143|Drug|Dabrafenib|Dabrafenib will be provided as 50 mg and 75 mg capsules.
16079308|NCT02314143|Drug|Trametinib|Trametinib study medication will be provided as 0.5 mg and 2.0 mg tablets.
16079309|NCT02314130|Dietary Supplement|Dietary therapy|A enteral diet formulation was developed to meet dietary requirements of adult patients. The formulation was standarized in household measures so that caregivers would prepare it and delivered it at the patients' home. Anthropometric measurements and blood samples were taken at baseline and at the end of the intervention which lasted four months.
16079310|NCT02314117|Drug|Ramucirumab|Administered IV
16079311|NCT02314117|Drug|Capecitabine|Administered orally
16079312|NCT02314117|Drug|Cisplatin|Administered IV
16079313|NCT02314117|Drug|Placebo|Administered IV
16079314|NCT02314117|Drug|Fluorouracil|Administered IV
16079315|NCT02314104|Drug|ropivacaine|Treatment local injection was 2 mL of 0.5% ropivacaine at each port site. Treatment TAP was 30 mL of 0.5% ropivacaine bilaterally.
16079316|NCT02314091|Procedure|onlay mesh hernioplasty|
16079412|NCT02313220|Drug|Placebo|Oral and Subcutaneous use.
16079317|NCT02314065|Behavioral|CBT, exposure and response prevention (Face-to-face)|"This intervention entails different exercises aimed at exposure to health anxiety stimuli.
~Treatment is delivered in a conventional manner. Participants are physically meeting with a therapist once a week."
16079318|NCT02314065|Behavioral|CBT, exposure and response prevention (Internet-based)|"This intervention entails different exercises aimed at exposure to health anxiety stimuli.
~Treatment is delivered via the Internet. Participants are guided by a therapist using an email-like communication system."
16079319|NCT02314052|Drug|DCR-MYC|"Dosing: 2 hour IV infusion on Day 1 and 8 of each 21 day cycle.
~Starting dose: 0.125mg/kg/dose
~Number of cycles: until progression or unacceptable toxicity develops.
~PHASE 1b Dose escalation: 50% or 25% increase in subsequent cohorts depending upon toxicity until maximum tolerated dose (MTD) is identified.
~PHASE 2 Cohort expansion at the MTD: Additional patients to be treated at the highest dose tolerated to assess efficacy and further assess safety"
16079320|NCT02314026|Device|Suspected NASH BreathID test with 13C-Octanoate|Subject will have breath measured before and after ingestion of solution of 100 mg 13C Octanoate dissolved in 150 cc of water
16079321|NCT02314026|Device|Suspected NASH Breath test with 13C Methacetin|Subject will have breath measured before and after ingestion of solution of 75 mg 13C Methacetin dissolved in 150 cc of water
16079322|NCT02314013|Drug|Cephalosporin + Metronidazole|intravenous antibiotics injection (3rd generation cephalosporin + metronidazole)and then change to oral antibiotics (3rd generation cephalosporin+ metronidazole) (an expected average 10 days)
16079323|NCT02314000|Device|Precision or Precision Spectra Spinal Cord Stimulator System|
16079324|NCT02313974|Procedure|Renal Biopsy|
16079325|NCT02313961|Other|Remote ischaemic conditioning|Remote ischaemic conditioning is induced by 3 cycles of manual inflation of a blood pressure cuff placed on the left lower limb to 200 mmHg for 5 minutes and then deflation to 0 mmHg for another 5 minutes.
16079326|NCT02313935|Other|LLM|LLM training Participants use the FitForAll exergaming computer platform as the physical training component (PTC); Participants use the language adapted Version of the BrainFitness Program as the cognitive training component (CTC)
16079327|NCT02313935|Other|FFA|PTC training Participants use the FitForAll exergaming computer platform as the physical training component (PTC)
16079328|NCT02313935|Other|Brain Fitness|CTC training Participants use the language adapted Version of the BrainFitness Program as the cognitive training component (CTC)
16079329|NCT02313935|Other|VideoGrade|Active cognitive training by use of the VideoGrade software by AUTH.
16079330|NCT02313922|Drug|etanercept combined with methotrexate or etanercept combined with placebo|
16079331|NCT02313909|Drug|Rivaroxaban (Xarelto, BAY59-7939)|15 mg, once daily, orally, tablet
16079332|NCT02313909|Drug|Acetylsalicylic acid (Aspirin, BAY1019036)|100 mg, once daily, orally, tablet
16079333|NCT02313909|Other|Rivaroxaban-Placebo|Matching placebo, once daily, orally, tablet
16079334|NCT02313909|Other|Aspirin-Placebo|Matching placebo, once daily, orally, tablet
16079335|NCT02313896|Behavioral|Phone calls|Phone calls from medical staff assess confusion of the patient, and recommend immediate changes to dosage of lactulose.
16079336|NCT02313883|Drug|PerioSept(r)|Taurolidine is derived from the amino acid taurine and has antimicrobial and immune modulating properties
16079337|NCT02313870|Drug|clobetasol propionate + Methotrexate|daily applications of topical clobetasol propionate at a dose of 10 to 30 g / day depending on the patient's weight and the initial number of new blisters per day, associated with methotrexate (MTX) received either orally or subcutaneously at a dose of 12.5 mg / week in patients weighing less than 60 kg and with creatinine clearance greater than 50 ml / min (planned dose reduction to 10 mg / week in patients less than 60 kg or with a creatinine clearance less than 50 ml / min) for four weeks followed by oral or subcutaneous methotrexate alone at the same dose during following 8 months
16079338|NCT02313870|Drug|clobetasol propionate alone|daily applications of topical clobetasol propionate at a dose of 10 to 30 g / day depending on the patient's weight and the initial number of new blisters per day, up to 14 days after control of the disease followed by 1 application every 2 days at the same dose for 4 weeks then an application twice a week for 4 weeks then once application a week until the end of the 9th month of treatment
16079339|NCT02313857|Biological|Viralym-C|"Follow-up Assessments: The timing of follow-up visits is based on the date of Viralym-C infusion. If a patient has multiple Viralym-C infusions the schedule resets again at the beginning so follow up relates to the last Viralym-C infusion.
~Follow up will occur at 7 days, 14 days, 21 days, 28 days, 35 days, 42 days, 90 days, 180 days, and 365 days post enrollment."
16079340|NCT02313844|Biological|Viralym-B|"Follow-up Assessments: The timing of follow-up visits is based on the date of Viralym-B infusion. If a patient has multiple Viralym-B infusions the schedule resets again at the beginning so follow up relates to the last Viralym-B infusion.
~Follow up will occur at 7 days, 14 days, 21 days, 28 days, 42 days, 90 days, 180 days, and 365 days post enrollment."
16079341|NCT02313831|Other|Interval training|Patients of this group will be submitted to an interval training program
16079342|NCT02313818|Behavioral|Cognitive Processing Therapy-Cognitive Only|Cognitive Processing Therapy-Cognitive Only (CPT-C) is an evidence-based form of Cognitive Behavioral Therapy (CBT) used to treat PTSD. CPT is a manualized program that focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. Individual sessions will be conducted twice weekly for 4-24 sessions; each session is 60 minutes.
16079343|NCT02313805|Other|Checklist|The checklist is a simple A4 size, two sided, document. Eleven checklist items covering twenty-one key educational points are on the front. Images illustrating the process of using a syringe to draw up insulin from a vial as well as injection sites (for children, adults and pregnant women) are on the back.
16079344|NCT02313792|Drug|Palifermin|
16079345|NCT02313779|Behavioral|Lovingkindness Meditation (LKM)|Compassionate behavior training (REVISE)
16079346|NCT02313779|Behavioral|Mindfulness Meditation|
16079347|NCT02313766|Other|PPV : positive pressure ventilation|Inspiratory pressure support ventilation (12 cmH2O) without PEEP
16079348|NCT02313766|Other|PEEP : PPV + PEEP|Inspiratory pressure support ventilation (12 cmH2O) with PEEP (6 cmH2O)
16079349|NCT02313753|Behavioral|CLASP|
16079350|NCT02313753|Behavioral|SAFE|
16079386|NCT02313389|Drug|Rituximab, Methotrexate, Temozolomide|Seven monthly R-MT cycles including high dose MTX (3.5g/m2, D1), TMZ, rituximab.
16079717|NCT02310789|Device|Macroduct sweat stimulator|
16079351|NCT02313740|Biological|Butantan Fragmented Inactivated Trivalent Influenza Vaccine|Subjects participating in the study are exposed to Butantan´s Fragmented Inactivated Trivalent Influenza Vaccine during vaccination campaign, and will have immunogenicity and safety related to the vaccine evaluated (observational study).
16079352|NCT02313727|Drug|Pamidronate|intravenous infusion of pamidronate 60 mg
16079353|NCT02313727|Other|Placebo (NaCl 0.9%)|intravenous infusion of NaCl 0.9% 500 ml
16079354|NCT02313714|Device|stimulation wave (2.5 kHz, burst at 50Hz, on/off: 3/9 sec),|All patients in the treatment arm will receive electric muscular stimulation with a Russian current protocol twice a week for 7 weeks.
16079355|NCT02313714|Device|Sham|very low electric muscular stimulation
16079356|NCT02313701|Other|Standardized visual presentation|Visual presentations will address what type of procedure they will undergo, the risks and benefits of the procedure (i.e. injury to nearby organs, risks of infection and bleeding, risk of re-operation), alternative treatments to the procedure, what to expect during the pre-operative period, and what to expect in the post-operative period (i.e. urinary catheter, constipation, pain management, hospital stay).
16079357|NCT02313688|Procedure|gastrectomy|Transabdominal (include transhiatal) D2 gastrectomy according JGCA gastric cancer treatment guidelines (2010, ver.3) and with 3±0.5 cm lengthen proximal resection margin.
16079358|NCT02313688|Procedure|gastrectomy|Transabdominal (include transhiatal) D2 gastrectomy according JGCA gastric cancer treatment guidelines (2010, ver.3) and with 5±0.5 cm lengthen proximal resection margin.
16079359|NCT02313675|Drug|Acetaminophen|
16079360|NCT02313675|Drug|Ketorolac Tromethamine|
16079361|NCT02313675|Drug|Saline|
16079362|NCT02313662|Device|NBI and PDD|
16079363|NCT02313623|Procedure|Prostate Fusion Biopsy|For subjects with scheduled fusion biopsies, we propose a research plan to acquire additional biopsy cores for research purposes without impacting clinical protocol. After acquiring clinically-necessary biopsies, we propose taking an additional research biopsy to establish a matched-pair of clinical and research samples.
16079364|NCT02313610|Drug|Qinbudan|Contains three kinds of traditional Chinese medicine radix scutellariae, radix stemona, liquorice
16079365|NCT02313610|Drug|Qinbudan Placebo|Qinbudan Placebo was the same as therapeutic drug in package,shape,size.
16079366|NCT02313597|Procedure|SETON|In seton treatment, initially Hydrogen peroxide will be applied to the external opening with a 10-cc syringe, and the internal opening will be located by direct visualization of the anal canal via proctoscope. A probe will be inserted into the external opening and carefully maneuvered through the internal opening. Silk 1/0 suture will be then tied to the tip of the probe, which will be then squeezed out of the external opening. The suture will be then tied around the sphincter and through fistula tract. Later, the seton will be tightened at four-week intervals under local anesthesia until the suture cut through the sphincter.
16079367|NCT02313597|Procedure|VAAFT|Patients assigned to the VAAFT group will receive the following procedure. The external opening will be widened with a probe, and a fistulascope will be inserted to delineate the primary and secondary tracts and locate the internal opening. The internal opening will be then stitched with Vicryl™ (Polyglactin 910) 2-0 suture through the anal route with the help of a proctoscope. The tract of the fistula will be washed and debrided through the scope and cauterized. Finally, the external opening will be excised and will be sent for biopsy.
16079368|NCT02313584|Drug|dabigatran|
16079369|NCT02313584|Drug|placebo|
16079370|NCT02313558|Drug|Dentifrice Containing Ilex Rotunda Thunb|Use the dentifrice to brush teeth twice a day for 12 weeks
16079371|NCT02313558|Drug|Control dentifrice|Use the dentifrice to brush teeth twice a day for 12 weeks
16079372|NCT02313545|Drug|IZN-6NVS Cream|"IZN-6NVS, a hydrocream containing three herbal extracts, is a polymolecular agent derived from botanical sources. It is composed of a blend of three herbal extracts, Centella asiatica, Echinacea purpurea, and Sambucus nigra.
~Cream concentration: 5%"
16079373|NCT02313519|Dietary Supplement|Probiotics|Probiotics are prepared in capsule form
16079374|NCT02313519|Dietary Supplement|Placebo|Glucose powder
16079375|NCT02313506|Behavioral|Education session, Fitbit Flex, and remote coaching by a PT|Participants will receive a brief education session, use of a commercially available physical activity tracker (Fitbit Flex), and remote counselling by a PT. Intervention will be received immediately.
16079376|NCT02313506|Behavioral|Same intervention with a 1 month delay|The Delayed Intervention Group will receive the same intervention as the Immediate Intervention Group, but with a 1 Month delay.
16079377|NCT02313493|Behavioral|Baby Triple P|
16079378|NCT02313480|Other|massage|Swedish massage was included in one arm of the study and not the other. Administered by a trained therapist as part of the usual 30 minute treatment time. Amount of massage administered dependant on Therapist's clinical reasoning
16079379|NCT02313467|Drug|Topical application of 1.5% Butenyl ALA|
16079380|NCT02313467|Drug|Topical application of sham control|
16079381|NCT02313454|Device|Intranasal Tear Neurostimulator|Neurostimulation applied intranasally and extranasally.
16079382|NCT02313441|Other|Remote Ischemic Pre-Conditioning|The blood pressure cuff was inflated to a pressure of 200 mm Hg for 5 minutes, followed by 5 minutes of deflation to allow reperfusion. This procedure was repeated 3 times by the resident doctors in the pre-cath room
16079383|NCT02313428|Device|Topical Oxygen Chamber for Extremities|Surrounds a limb and applies oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers
16079384|NCT02313415|Procedure|UC-MSCs therapy|Before considering whether patients meet the inclusion criteria, they are diagnosed as intrauterine adhesions with at least one unsuccessful hysteroscopic surgery. And after that there will be history taking, physical examination, ultrasound examination and hysteroscopy examination. If they agree to participate, they will receive separation of adhesions by hysteroscopy surgery and endometrial biopsies, then a collagen scaffold loaded with UC-MSCs will be transplanted into the uterine cavity. The procedure was performed after taking 6 mg/day × 10 days Progynova, continuous administration of the same dosage Progynova for 30 days and 60mg of progesterone were injected on the 30th day post-operation. Postoperative observation including ultrasound examination once a month for 3 times and hysteroscopy after 3 months. The doctor will select an appropriate time for pregnancy and follow-up including requiring patients to do some unscheduled visits.
16079385|NCT02313402|Device|EOL (Eye On Line)|the intervention consists in training program allowing a gradual acquisition of the eye-writing
16079387|NCT02313376|Biological|GAP3KO|GAP3KO administered via the bite of 150-200 GAP3KO-infected A. stephensi mosquitoes under controlled conditions.
16079388|NCT02313363|Device|patient-centered smartphone-based diabetes care system|patient-centered smartphone-based diabetes care system (PSDCS) is composed of 4 modules such as glucose module, diet module, physical activity module, and SNS module. Participants were instructed to use the PSDCS and to measure blood glucose levels with a Bluetooth glucometer, input daily food intake, and wear an activity tracker.
16079389|NCT02313350|Device|Chemonucleolysis with Discogel|Discogel® is provided in a kit containing a 2 ml solution for injection with two disposable 1ml syringes, each for single use which is stored at room temperature. Discogel® chemonucleolysis for herniated disc-related sciatica is performed under local anesthesia .
16079390|NCT02313350|Procedure|open discectomy|The comparator is open surgical discectomy. The procedure will be performed under general anesthesia. It will consist in removing the disc herniation after exposition and examination of the nerve root.
16079391|NCT02313337|Other|Oral administration|Premedicate--Oral administration of a mixture at preoperative 30 minutes: ketamine 3 mg/kg, midazolam 0.5 mg/kg and atropine 0.02 mg/kg, plus 50% glucose solution to 0.5ml /kg.
16079392|NCT02313337|Other|Intramuscular injection|Premedicate--At preoperative 30 minutes intramuscular injection of atropine 0.02 mg/kg, 5 minutes before entering the operation room, intramuscular injection of ketamine 5 mg/kg.
16079393|NCT02313337|Other|Rectal perfusion|Premedicate--At preoperative 30 minutes rectal infusion of midazolam 0.5mg/kg
16079394|NCT02313337|Other|Dripping nose|Premedicate--At preoperative 30 minutes dripping nose of Imidazole valium 0.2 mg/kg
16079395|NCT02313337|Drug|Anesthesia induction(midazolam,fentanyl,propofol,atracurium)|After entering the operation room ,all cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .
16079396|NCT02313337|Procedure|Intubation|Intubation when the trachea-oesophageal fistula（TOF） value fell 15%, BIS value dropped to 40.
16079397|NCT02313337|Drug|Anesthesia maintenance(midazolam,fentanyl,propofol,atracurium)|All cases intravenous midazolam 0.05 mg/kg, fentanyl 3μg/kg, closed-loop target controlled infusion propofol and atracurium .
16079398|NCT02313324|Device|Extracorporeal shock wave therapy (ESWT)|The patients received 2000 shots of extracorporeal shock wave therapy in the coccyx area per session for four sessions (one session a week for 4 consecutive weeks). The frequency used was 5 Hz and the pressure was 3-4 bar.
16079399|NCT02313324|Device|SWD combined IFC|The shortwave diathermy (SWD) was the inductive mode with a coil at a frequency of approximately 27.12 MHz. The shortwave diathermy applicator was placed over the sacrococcygeal area. The treatment duration was 20 minutes. After completing the SWD treatments, the patients received the interferential current (IFC) treatment. IFC provides deeper electrical stimulation. The electrical current was applied to the gluteal area using four electrodes from 2 channels of the stimulator. The four electrodes were set on the gluteal area. The carrier frequency, typically 4000 Hz and 4100 Hz and designed to interfere with each other, resulted in a beat frequency of 100 Hz within the treated area. The treatment duration was 20 minutes. The protocol was set as 3 times per week for a period of 4 weeks.
16079400|NCT02313311|Other|time-lapse imaging|Embryos are observed using time-lapse imaging (Primo Vision®). It is an incubator with a compact, sealed, and digitally inverted camera unit which can automatically acquire images.The system can record the actual developmental stage of the embryos, all the recorded images can be saved to be analyzed later using a special software program.
16079401|NCT02313298|Radiation|Stereotactic Body Radiotherapy|IMRT or similar techniques that use inverse treatment planning
16079402|NCT02313272|Radiation|Hypofractionated Stereotactic Irradiation (HFSRT)|Radiation therapy treatment (FSRT) which will be given to participants over 5 days.
16079403|NCT02313272|Drug|Pembrolizumab|"Dose Escalation: The dose of pembrolizumab will be escalated per schema in a 3+3 fashion. The starting dose (i.e., dose level 1) will be 100 mg.
~Dose Expansion: The pembrolizumab dose used in the dose expansion cohort will be maximum tolerated dose (MTD) determined from the dose escalation phase."
16079404|NCT02313272|Drug|Bevacizumab|Initial cycle of bevacizumab must start within 10 days of registering to the trial. It will be given concurrent with radiation therapy. Bevacizumab will be administered intravenously at a dose of 10 mg/kg every 2 weeks. Doses will be adjusted if there is a > 10% change in weight.
16079405|NCT02313259|Other|Speed discrimination test|"The participant has to stare in the middle of two screens, i.e the reference screen and the test screen. Dots are moving from the center to the edge of the screens at different speeds. The participant is forced to determine if the dots of the test screen are moving faster or slower than the reference screen.
~The test is designed in Psychtoolbox3. Data analyses performed using MATLAB. Two-alternative forced choice paradigm."
16079406|NCT02313259|Behavioral|Driving simulation|"25 km simulated car driving session. The participant is seated in the driver compartment of a real car featuring all the actual components (steering wheel, pedals regulating speed and brakes). He is instructed to respect road regulations as well as safety rules and must perform some driving manoeuvres, such has turning at intersections, stopping when necessary, passing another car, etc.
~Software Drive 3.0 by Systems Technology Inc., Hawthorne, California, USA. Magnetic head tracker (Flock of Birds, Ascension Technology Corporation, Burlington, Vermont, USA).
~A fixed-base driving simulator. 2 driving scenarios: a practice (10 minutes) and a main scenario including rural and urban sections (35 minutes)."
16079407|NCT02313246|Behavioral|Group Cognitive Behaviour Therapy|This 11-week group treatment will cover the following topics: psychoeducation about IBS and the role of stress in exacerbating IBS symptoms, progressive muscle relaxation, stress management, problem solving, identifying and modifying maladaptive thinking patterns, decreasing behavioural avoidance, and exposure to feared physical sensations.
16079408|NCT02313233|Dietary Supplement|Umooze|Umooze is consisted of Astragalus radix extracts and soy extracts. Astragalus radix (AR) is the dried root of Astragalus membranaceus Bge. Var. mongholicus and is used as a tonic in the traditional Chinese medicine. According to the reports submitted by the National Cancer institute of American, people who eat soybean products can reduce the incidence rate for prostate cancer. The composition of Umooze is invented by Golden Biotechnology Corp. against prostatic hyperplasia.
16079409|NCT02313233|Dietary Supplement|Placebo|Placebo is consisted of cornstarch and is provided by by Golden Biotechnology Corp.
16079410|NCT02313220|Drug|Dapagliflozin|Oral use
16079411|NCT02313220|Drug|Exenatide|Powder and solvent for suspension for injection, prolonged release suspension. Subcutaneous use.
16079413|NCT02313207|Dietary Supplement|FODMAP|patients will undergo a specific FODMAP diet for a period of 2 weeks.
16079414|NCT02313194|Device|Epidural Stimulation|Determine if epidural stimulation can improve motor function
16079415|NCT02313194|Drug|Buspirone|Determine if the pharmacological agent in combination with the stimulator can improve motor function.
16079416|NCT02313181|Other|Early Limited Formula|10 milliliters (mL) Nutramigen fed to baby by syringe after each breastfeeding and discontinued at the start of mature milk production
16079417|NCT02313181|Other|Standard Care|Continue exclusive breastfeeding unless otherwise directed by a health care provider
16079418|NCT02313168|Other|observation, inspection|
16079419|NCT02313155|Drug|Subcutaneous injection of TAK-850|TAK-850 0.5 mL, Subcutaneous injection
16079420|NCT02313155|Drug|Intramuscular injection of TAK-850|TAK-850 0.5 mL, Intramuscular injection
16079421|NCT02313142|Behavioral|Leg exercises|
16079422|NCT02313116|Device|Interferometric Synthetic Aperture Microscopy|Optical coherence tomography with interferometric synthetic aperture microscopy will be used to image ex vivo breast tissue specimens.
16079423|NCT02313103|Drug|lofexidine HCl|400 micrograms
16079424|NCT02313090|Other|Welltang|The intervention group installed Welltang (downloaded from www.welltang.com for free) designed by Shanghai Geping Information and Technique Company Ltd (Shanghai, China) on their cell phones. Welltang is a cell phone- based diabetes management application that consists of three main parts: knowledge, self-management, communication between patients and clinicians
16079425|NCT02313077|Biological|MVA-BN-filo|One 0.5 mL intramuscular (IM) injection of 1E8 (50%Tissue Culture Infectious Dose [TCID50]) on Day 1 (Groups 1 and 2), or on Day 29 (Group 3), or on Day 57 (Group 4), or on Day 15 (Group 5).
16079426|NCT02313077|Biological|Ad26. ZEBOV|One 0.5 mL IM injection of 5E10 viral particles (vp) on Day 1 (Groups 3, 4 and 5), or on Day 29 (Group 1), or on Day 57 (Group 2).
16079427|NCT02313077|Other|Placebo|One 0.5 mL IM injection of 0.9% saline on Day 1 and 29 (Groups 1 and 3), or on Day 1 and 57 (Groups 2 and 4).
16079428|NCT02313064|Drug|CXA-10|Part A has sequential single ascending doses will be administered in up to 5 cohorts of subjects. Each cohort of subjects will be randomized to receive a single dose of CXA-10 or placebo in, a fasted state. Part B has 2 periods and subjects will receive two doses of the selected dose of CXA-10.
16079429|NCT02313064|Drug|CXA-10 placebo|
16079430|NCT02313051|Drug|Everolimus|mTOR inhibitor
16079431|NCT02313051|Drug|Goserelin|
16079432|NCT02313051|Drug|Letrozole|
16079433|NCT02313025|Other|speech sound intervention|"An intervention that stimulates speech sound perception and production in four-year-olds.
~Each day at preschool the children receive a 15 to 20 minutes intervention, for 12 weeks"
16079434|NCT02313025|Other|World-project|An intervention that stimulates vocabulary development in four-year-olds. Each day at preschool the children receive a 120 minutes intervention, for 10 weeks
16079435|NCT02313012|Drug|CC-90003|CC-90003 PO once daily
16079436|NCT02312999|Drug|Plasmalyte|
16079437|NCT02312999|Drug|Volulyte|
16079438|NCT02312986|Biological|Fecal microbiota transplantation (FMT)|Prospective pilot study to examine whether fecal microbiota transplantation (FMT) is able to suppress or reverse gastrointestinal carriage of multi-drug resistant organisms.
16079439|NCT02312973|Drug|Molidustat(BAY85-3934)|Two single oral doses of 75 mg molidustat tablet in subjects on hemodialysis and peritoneal dialysis
16079440|NCT02312973|Drug|Molidustat(BAY85-3934)|One single oral dose of 75 mg molidustat in healthy subjects
16079442|NCT02312947|Device|coblation (COBLATION II surgery system ,CE8001-01)|comparison of two methods of operation : coblation and cold dissection
16079443|NCT02312947|Device|cold dissection adenoidectomy|comparison of two methods of operation : coblation and cold dissectionby currete
16079444|NCT02312934|Drug|Transdermal nicotine|Nicotine patches are currently FDA approved for smoking cessation. Nicotine has effects that have been well studied for many years. Studies have shown that nicotine by itself does not appear by itself to be cancer causing. The use of the nicotine patch is not expected to increase risk of breast cancer recurrence.
16079445|NCT02312934|Other|Placebo Transdermal Patch|Matching transdermal placebo patches will be used. Participants will follow the same titration schedule as the transdermal nicotine arm.
16079446|NCT02312921|Other|PREDICT|Allied dental personnel provide screening and preventive services in community settings and case managers serve as patient navigators to arrange referrals of children who need dentist services. The intervention is paired with a compensation system for high performance (pay-for-performance) with efficient performance monitoring. PREDICT focuses on: 1) identifying eligible children and gaining caregiver consent for services in community settings (e.g., schools); 2) providing risk-based preventive and caries stabilization services efficiently at these settings; 3) providing curative care in dental clinics; and 4) incentivizing local delivery teams to meet performance benchmarks.
16079447|NCT02312908|Drug|Clonazepam|For experimental treatment of RBD
16079448|NCT02312908|Drug|Placebo|Placebo pill manufactured to mask clonazepam 0.5mg tablet
16079449|NCT02312895|Other|Manual therapy|The therapist will locate the involved segment using passive accessory intervertebral movements. The segment will be localized to the level, which provokes the patient's symptoms most easily, and this segment will be determined to be the involved level. Once this level has been identified, the therapist will compare central glides over the spinous process or a unilateral glide over the facet joint to determine which is more provocative. Whichever is most provocative will be the location of the treatment. The therapist will provide 3 bouts lasting 45 seconds just easing into the patient's symptoms at the most provocative level with approximately 45 seconds rest between each bout.
16079478|NCT02312661|Drug|Carboplatin|Intravenous carboplatin chemotherapy in three-weekly cycles, for a maximum of 6 cycles
16079479|NCT02312661|Drug|Paclitaxel|Intravenous paclitaxel chemotherapy in three-weekly cycles, for a maximum of 6 cycles
16079508|NCT02312440|Drug|tranexamic acid|"The Tranexamic Acid solution will be prepared under sterile conditions. In the operation room the sterile bag containing the solution will be given to the circuit nurse and the circuit nurse will ask the anesthetist to apply the solution intravenously before tourniquet deflation. The dosage and applying route can also be looked up in doctor's order sheet.
~60 Milliliters（ml） by irrigation for 3 minutes before wound closure."
16079450|NCT02312895|Other|Dry needling|Dry needling involves inserting a dry, mono-filament needle through the skin and into an area of symptomatic soft tissue. The two-inch needles will be placed segmentally and into the lower extremities following peripheral nerve patterning by the treating physical therapist. Following initial penetration into the skin over the tender area, the therapist carefully advances the needle into the tissue below the skin. After the needle has reached the desired depth, the therapist will insert the subsequent needles. Needles will be placed along the segmental levels of the lumbar spine above and below the tender area identified and into the lower extremity in areas that correlate with a peripheral nerve map. Needles will remain in the tissue for up to 5 minutes, removed, and appropriately disposed of.
16079451|NCT02312895|Other|Home Exercise Program|A home exercise program will be given to each subject to be completed in the clinic and at home 1x/day. The exercises will consist of active range of motion exercises and core stabilization exercises. The program is standardized for all subjects.
16079452|NCT02312882|Drug|Tofacitinib|Tofacitinib 5 mg tablet taken by mouth twice a day.
16079453|NCT02312869|Other|No intervention|not applicable, observational study
16079454|NCT02312856|Device|PulseRider|Adjunctive device for endovascular embolization of intracranial aneurysms
16079455|NCT02312843|Behavioral|Exercise/Aerobic|
16079456|NCT02312843|Behavioral|Exercise/Stretching|
16079457|NCT02312817|Other|Mailed Outreach Invitation|"Individuals randomized to Group 2 will receive:
~Mailed outreach invitation to complete HCC screening ultrasound and alpha-fetoprotein (AFP) blood test.
~Live phone calls 2 to 4 weeks after the mailed invitation to facilitate HCC screening completion. Up to three attempts will be made. All communications will use standard English or Spanish scripts.
~Centralized process to promote guideline-appropriate follow up testing with CT or MRI or referral to GI Clinic."
16079458|NCT02312817|Other|Mailed Outreach Invitation and Patient Navigation|"Individuals randomized to Group 3 will receive:
~Mailed outreach invitation to complete HCC screening ultrasound and alpha-fetoprotein (AFP) blood test.
~Live phone calls 2 to 4 weeks after the mailed invitation to facilitate HCC screening completion and address patients' self-reported barriers to HCC screening (e.g., it does not apply to me). Up to three attempts will be made. All communications will use standard English or Spanish scripts.
~Centralized navigation to promote screening completion (i.e., appointment reminder phone calls from patient navigator) and guideline-appropriate follow up testing with CT or MRI or referral to GI Clinic."
16079459|NCT02312804|Drug|BGJ398|BGJ398 will be administered orally once daily on each day of the 21 day cycle.
16079460|NCT02312804|Drug|Carboplatin|Carboplatin will be administered in combination with paclitaxel intravenously on the first day of each 21-day cycle.
16079461|NCT02312804|Drug|Paclitaxel|Paclitaxel will be administered in combination with carboplatin intravenously on the first day of each 21-day cycle.
16079462|NCT02312778|Other|HVLA Manipulation|Intervention Group who receives a high velocity and low amplitude (HVLA) lumbar manipulation. A manual procedure also known as high velocity and low amplitude lumbar spinal manipulation are delivered for the subjects in the side lying position. The lumbar segment more restrict (mobility restriction) will be the target region for the manipulative procedure.
16079463|NCT02312765|Behavioral|AirCare App|Tablet software to encourage adherence and support
16079464|NCT02312752|Device|Intra-epidermal stimulation electrode|"A small piece of plastic with a tiny sharp protruding tip (the intra-epidermal stimulation electrode) will be applied to the foot and hand. Small sticker electrodes will be placed over nerves on the forearm or ankle. A stimulus will be applied to the electrode for intra-epidermal stimulation. The stimulus will be gradually increased from no stimulus to a stimulus that is barely felt as a pin-prick type of sensation. Thereafter, the stimulus will be applied 5-15 times per second for 10 periods of 40-60 seconds."
16079465|NCT02312739|Procedure|In-office Transcervical Sterilization (Essure®)|The standard transcervical sterilization procedure is not being evaluated in this study, and will be performed in the same manner in the two study arms. The procedure includes a standardized paracervical block with 1% lidocaine. A 5mm operative hysteroscope is passed through the cervix and into the uterine cavity using normal saline for uterine distention. Each tubal ostium is identified, followed by deployment of the device into each fallopian tube. A confirmatory test, hysterosalpingogram, is required at 90 days post procedure to demonstrate successful sterilization.
16079466|NCT02312739|Drug|Standard Oral pain medications|one 5/325mg hydrocodone/acetaminophen (Vicodin) tablet and one 1mg Lorazepam tablet given to patients randomized to the active comparator arm at least 30 minutes before the procedure
16079467|NCT02312739|Drug|Intramuscular Ketorolac|30mg of intramuscular ketorolac given to all patients at least 30 minutes before the procedure
16079468|NCT02312739|Drug|Placebo pills|Two placebo bills given to patients randomized to the experimental arm at least 30 minutes prior to the procedure
16079469|NCT02312739|Other|Oxygen|Oxygen at 5L/min given to patients randomized to the active comparator arm
16079470|NCT02312739|Other|Nitrous Oxide|Nitrous oxide with a maximum titration of up to 70% given to patients randomized to the experimental arm
16079471|NCT02312726|Procedure|Postplacental IUD insertion|Postplacental IUD insertion using the standardized ring forceps technique (Speroff and Mishell 2008) under ultrasound guidance, within 10-30 minutes of vaginal delivery.
16079472|NCT02312713|Behavioral|Internet Based Exercise Training|"Participants assigned to the PT arm will receive 3-8 individual visits with a physical therapist. The content of these visits will be semi-standardized, meaning that they will include some common core components (e.g., evaluation, prescription of home exercise program), but the therapists will have flexibility in terms of how many visits are appropriate and the details of the visit content."
16079473|NCT02312713|Behavioral|Physical Therapy|Participants assigned to the internet-based exercise training arm will be given access to a program that aims to tailor exercises based on individuals' functional levels. The program assigns specific exercises, progresses these exercises as appropriate over time, and shows individual video clips to demonstrate appropriate performance of exercises.
16079474|NCT02312700|Behavioral|Interactive empowerment tool|
16079475|NCT02312687|Biological|KRN23|solution for SC injection
16079476|NCT02312674|Dietary Supplement|Oral nutritional supplement|Beginning with the start of palliative therapy, depending on the nutritional status, one, two, or three cans per day are ingested during a period of three months.
16079477|NCT02312661|Drug|Metformin|Metformin in increasing doses will be added to carboplatin/paclitaxel chemotherapy
16079480|NCT02312648|Other|Interventional Group|Respiratory exercises will be performed and subsequently active upper limb exercises will be conducted (flexion-extension and adduction-abduction) of large joints (shoulder, elbow and wrist) Associated with upper limb exercises, patients will undergo a series of exercises ergometer with lower limb (LL). The mobilization will be conducted on a cycle ergometer in an active, lasting 20 minutes, divided into three steps: heat 5 minutes; 10 minutes of low intensity exercise, with a speed of 30 revolutions per minute (rpm); and 5 minutes recovery. The patient remains in the supine position with the head of the bed elevated to 45 degrees, while the lower limbs will remain planned. After positioning the patient, the ergometer is adjusted.
16079481|NCT02312648|Other|Control group|The patients will oriented to maintain sitting position and perform deep breaths (3 sets of 10 repetitions) in each session. They will receive the intervention once a day, for 30 minutes until 7th postoperative day. In addition, non invasive ventilation will be installed after orotracheal extubation for 30 to 60 minutes.
16079482|NCT02312635|Drug|D-Cycloserine|Half of the participants will be randomly chosen to receive the medication D-cycloserine in addition to the working memory program, while the other group will receive an inactive pill (placebo).
16079483|NCT02312635|Behavioral|Cogmed Working Memory Training|Both arms of the study will receive Cogmed working memory training for 6 weeks, M-F.
16079484|NCT02312622|Drug|Pegylated Irinotecan|Administered intravenously (IV) at 145 mg/m² as monotherapy once every 21 days (1 cycle)
16079485|NCT02312609|Drug|Minocycline hydrochloride|extended release tablets 135 mg
16079486|NCT02312596|Device|PRP Concepts Fibrin Bio-Matrix|Application of PRP Concepts Fibrin Bio-Matrix in addition to usual and customary practice
16079487|NCT02312596|Other|Usual and Customary Practice|Usual and customary care for non-healing wounds
16079488|NCT02312583|Behavioral|Psychoeducational online information|Psychoeducational online information. During 7 weeks as a complement to the usual treatment. Participants will have access to online psychoeducational material for depression.
16079489|NCT02312583|Behavioral|iFightDepression online programme|"iFightDepression online programme. During 7 weeks as a complement to the usual treatment.
~Participants will complete the modules of a structured online programme for depression"
16079490|NCT02312570|Device|PRP Concepts Fibrin Bio-Matrix|Administration of PRP Concepts Fibrin Bio-Matrix to wound in addition to usual and customary care
16079491|NCT02312570|Other|Usual and Customary Practice|Ussual and customary care of non-healing pressure wounds
16079492|NCT02312557|Drug|Enzalutamide|Given PO
16079493|NCT02312557|Other|Laboratory Biomarker Analysis|Correlative studies
16079494|NCT02312557|Biological|Pembrolizumab|Given IV
16079495|NCT02312544|Drug|OTX-TP|OTX-TP and placebo drops
16079496|NCT02312544|Drug|Timolol|Timolol drops and placebo punctum plug
16079497|NCT02312531|Drug|Hepatitis B immunoglobulin|Hepatitis B immunoglobulin 200 IU injection at gestational week 20, 24, 28, 32, 34, 36, 38, 39, and 40 in HBIG group mothers.
16079498|NCT02312518|Device|PRP Concepts Fibrin Bio-Matrix|PRP Concepts Fibrin Bio-Matrix in addition to usual and customary practice
16079499|NCT02312518|Other|Usual and Customary Practice|Usual and Customary Practice for non-healing venous leg ulcers
16079500|NCT02312505|Device|COPFX|cardiac Output by semi-invasive pulse contour analysis
16079501|NCT02312492|Other|Oleic Diet|The 18:1 (oleic) diet will contain 55%E carbohydrate, 15%E protein, 30%E fat, 100 mg cholesterol/1000 kcal and 15 g fiber/1000 kcal. The vegetable oils and/or fats (henceforth collectively referred to as experimental oils) that will be used to formulate the diets were selected not only take into account the fatty acid of interest but also the fatty acid displaced within the context of an unchanged total fat content. This was accomplished by formulating a diet containing 10%E fat and then adding the experimental oils (oleic) to 30%E total fat by incorporating them into various food items intended for consumption throughout the day. The actual food items comprising the 3 diets will be similar, only differing in the experimental oils.
16079502|NCT02312492|Other|Palmitic Diet|The 16:0 (palmitic) diet will contain 55%E carbohydrate, 15%E protein, 30%E fat, 100 mg cholesterol/1000 kcal and 15 g fiber/1000 kcal. The vegetable oils and/or fats (henceforth collectively referred to as experimental oils) that will be used to formulate the diets were selected not only take into account the fatty acid of interest but also the fatty acid displaced within the context of an unchanged total fat content. This was accomplished by formulating a diet containing 10%E fat and then adding the experimental oils (palmitic) to 30%E total fat by incorporating them into various food items intended for consumption throughout the day. The actual food items comprising the 3 diets will be similar, only differing in the experimental oils.
16079503|NCT02312492|Other|Stearic Diet|The 18:0 diet (stearic) will contain 55%E carbohydrate, 15%E protein, 30%E fat, 100 mg cholesterol/1000 kcal and 15 g fiber/1000 kcal. The vegetable oils and/or fats (henceforth collectively referred to as experimental oils) that will be used to formulate the diets were selected not only take into account the fatty acid of interest but also the fatty acid displaced within the context of an unchanged total fat content. This was accomplished by formulating a diet containing 10%E fat and then adding the experimental oil (stearic) to 30%E total fat by incorporating them into various food items intended for consumption throughout the day. The actual food items comprising the 3 diets will be similar, only differing in the experimental oils.
16079504|NCT02312479|Device|Nyxoah SAT system|The Nyxoah SAT system is comprised of an implantable nerve stimulator implanted over one of the tongue muscles via a minimally invasive procedure. Stimulation of the Hypoglossal nerves causes the tongue muscles to contract, thus maintaining an open airway during sleep.
16079505|NCT02312453|Procedure|Posterior approach|We adopted the technique as described by Hebbard et al.
16079506|NCT02312440|Drug|0.9% sodium chloride|The normal saline solution will be prepared under sterile conditions. In the operation room the sterile bag containing the solution will be given to the scrub nurse. The contents (60 ml) will be emptied in a sterile surgical bowl and the nurse will ask the surgeon to apply the solution before wound closure.The dosage and applying route can also be looked up in doctor's order sheet.
16079507|NCT02312440|Drug|tranexamic acid|The Tranexamic Acid solution will be prepared under sterile conditions. In the operation room the sterile bag containing the solution will be given to the scrub nurse. The contents (60 ml) will be emptied in a sterile surgical bowl and the nurse will ask the surgeon to apply the solution before wound closure.The dosage and applying route can also be looked up in doctor's order sheet.
16079757|NCT02310477|Drug|regorafenib|regorafenib for all groups
16079509|NCT02312427|Drug|Suspending DPP-4 inhibitor, in outpatient service|After baseline data collection, DPP-4 inhibitor (sitagliptin, vildagliptin, alogliptin, linagliptin, teneligliptin, anagliptin or saxagliptin) will be suspended for one month and serum BNP will be measured. The DPP-4 inhibitor will be resumed and after another month, serum BNP will be measured again.
16079510|NCT02312427|Drug|Starting DPP-4 inhibitor after treatment of heart failure|After hospitalization, medication for diabetes will be suspended. During the treatment for heart failure, drugs other than DPP-4 inhibitor will be resumed when required. After the stabilization of heart failure, DPP-4 inhibitor will be resumed (or administered if it was not prescribed before hospitalization) and serum BNP before and after the initiation of DPP-4 inhibitor will be measured.
16079511|NCT02312427|Drug|Suspending DPP-4 inhibitor after treatment of heart failure|After hospitalization, medication for diabetes may be suspended or continued. During the treatment for heart failure, drugs including DPP-4 inhibitor will be resumed when required. After the stabilization of heart failure, DPP-4 inhibitor will be suspended and serum BNP before and after the suspension of DPP-4 inhibitor will be measured.
16079512|NCT02312414|Drug|L-Canitine|Carnitine is a quaternary ammonium compound biosynthesized from the amino acids lysine and methionine, it is essential for the transport of fatty acids from the intermembraneous space in the mitochondria, into the mitochondrial matrix during the breakdown of lipids (fats) for the generation of metabolic energy
16079513|NCT02312401|Device|multi-parametric MRI(MP-MRI)|
16079514|NCT02312401|Device|dynamic contrast-enhanced MRI (DCE)|
16079515|NCT02312401|Procedure|biopsy|
16079516|NCT02312388|Other|catheter-over-the-needle technique|using a 22 G Angiocath Plus™ catheter
16079517|NCT02312388|Other|Thin-wall needle technique|using 18 - 21 G introducer needle
16079518|NCT02312375|Drug|Fimasartan|16 weeks of fimasartan vs. amlodipine followed by 2 weeks of wash-out period, then crossover
16079519|NCT02312375|Drug|Amlodipine|16 weeks of fimasartan vs. amlodipine followed by 2 weeks of wash-out period, then crossover
16079520|NCT02312362|Procedure|Combined sclerotomy ab interno and phaco|
16079521|NCT02312362|Procedure|Phacoemulsification with IOL implantation|
16079522|NCT02312336|Other|Cohort A - Room temperature coronary perfusate|Patients recruited into the study will receive standard PPCI and in addition a transcoronary infusion of Hartmans solution at room temperature (Cohort A). The research intervention is the infusion of room temperature Hartmans solution.
16079523|NCT02312336|Other|Cohort B - Cooled coronary perfusate|"Patients recruited into the study will receive standard PPCI and in addition a transcoronary infusion of Hartmans solution cooled at 15 degrees (Cohort B).
~The research intervention is the infusion of Hartmans solution cooled to 15 degrees."
16079524|NCT02312323|Device|Definitive 65 HPT contact lenses|
16079525|NCT02312323|Device|Definitive 65 contact lenses|
16079526|NCT02312310|Dietary Supplement|Cocoa Flavanol|12 weeks administration of cocoa flavanol
16079527|NCT02312297|Drug|Minocycline hydrochloride|extended release tablets 135 mg
16079528|NCT02312271|Other|enteral formula|standard tube feeding formulas
16079529|NCT02312258|Drug|Placebo|Ixazomib placebo-matching capsules.
16079530|NCT02312258|Drug|Ixazomib|Ixazomib capsules.
16079531|NCT02312245|Biological|Bevacizumab|Given IV
16079532|NCT02312245|Drug|Gemcitabine Hydrochloride|Given IV
16079533|NCT02312245|Drug|Paclitaxel|Given IV
16079534|NCT02312245|Drug|Pegylated Liposomal Doxorubicin Hydrochloride|Given IV
16079535|NCT02312245|Drug|Topotecan Hydrochloride|Given IV
16079536|NCT02312232|Drug|levodopa, carbidopa, ODM-104|
16079537|NCT02312219|Drug|Folic Acid|1 mg folic acid once daily
16079538|NCT02312219|Drug|Placebo|placebo once weekly
16079539|NCT02312219|Drug|Low Dose Methotrexate|An anti-inflammatory drug
16079540|NCT02312206|Drug|NEOD001|NEOD001, is a humanized immunoglobulin G1 monoclonal antibody, which specifically targets misfolded light chain aggregates and amyloid deposits. NEOD001 is proposed for use to target the misfolded light chain protein in subjects with AL amyloidosis.
16079541|NCT02312206|Other|Placebo|Placebo
16079542|NCT02312180|Biological|Plasminogen (Human) Intravenous|Plasma-derived purified plasminogen formulated for intravenous administration
16079543|NCT02312167|Device|confocal laser endomicroscopy|probe-based and needle-based confocal laser endomicroscopy
16079544|NCT02312154|Device|Restylane Vital|stabilized hyaluronic acid (HA)-based gel of nonanimal origin
16079545|NCT02312128|Other|Questionnaire|DASH Score, PRWE Score, Mayo Wrist Score
16079546|NCT02312128|Radiation|X- Ray|X-ray exposures in two planes 6., 9., 12. postoperative week, half and one year after surgery
16079547|NCT02312128|Other|Grip Strength|Grip strength measurement
16079548|NCT02312128|Other|VAS Score|Measurement pain according to the visual analogue scale (VAS)
16079549|NCT02312128|Other|Range of Motion measurement|Angle measurement of the active range of motion in the wrist
16079550|NCT02312115|Drug|Furosemide|Diuretic
16079551|NCT02312115|Drug|Placebo|Saline
16079552|NCT02312102|Drug|Lenalidomide|Chemotherapy
16079553|NCT02312102|Drug|Velcade|Chemotherapy
16079554|NCT02312089|Drug|Triptorelin|Luteal phase support will be continued by the same regimen started on the day of oocytes retrieval until 2 weeks after embryo transfer (ET) with subcutaneous administration of a single dose (0.2 mg) of GnRHa (Triptorelin) 6 days after oocyte retrieval
16079555|NCT02312076|Drug|Triptorelin|Luteal phase support will be continued by the same regimen started on the day of oocytes retrieval until 2 weeks after embryo transfer (ET) with subcutaneous administration of a single dose (0.2 mg) of GnRHa (Triptorelin) 6 days after oocyte retrieval
16079556|NCT02312063|Drug|Sitagliptin|
16079557|NCT02312063|Drug|Glimepiride|
16079558|NCT02312050|Drug|GCS-100|1 mg, 3 mg, or 9 mg IV push injections
16079559|NCT02312050|Drug|Placebo|
16079560|NCT02312037|Biological|Antibody Drug Conjugate Chemotherapeutic|"Three Treatment Regimens:
~Mylotarg <=9 mg/m2 as a single agent on Day 1 & 14 of a 28-day cycle for a total of two cycles
~Mylotarg in combination with a recognized anthracycline and/or nucleoside-antagonist containing regimen
~Mylotarg as monotherapy or in tested combinations with ATRA and/or arsenic trioxide for APL"
16079758|NCT02310464|Drug|OBI-833/OBI-821|
16079561|NCT02312024|Device|Use of CytoSorb adsorber|Use of CytoSorb adsorber either in patients with severe sepsis/septic shock or with cardiac surgery with CPB or in other patients.
16079562|NCT02312011|Drug|IONIS-DMPKRx|Drug
16079563|NCT02312011|Drug|Placebo|Placebo
16079564|NCT02311998|Drug|Bosutinib|Given PO
16079565|NCT02311998|Biological|Inotuzumab Ozogamicin|Given IV
16079566|NCT02311998|Other|Laboratory Biomarker Analysis|Correlative studies
16079567|NCT02311985|Other|Coagulogram-based protocol|The interventions for this protocol include transfusion of fresh frozen plasma, platelets (random or aphaeresis) and/or cryoprecipitate, based on international normalised ratio (INR), partial thromboplastin time (PTT), platelet count and/or fibrinogen. If INR >1.5 or PTT >50 sec., fresh frozen plasma is administered (dose: 10 mL/Kg); and/or platelets <50,000/microliter, random or aphaeresis platelets are administered (01 unit/Kg or 01 aphaeresis); and/or fibrinogen <150 mg/dL, cryoprecipitate is administered (dose: 01 unit/Kg).
16079568|NCT02311985|Other|Thromboelastometry-based protocol|The interventions for this protocol include transfusion of fresh frozen plasma, platelets (random or aphaeresis) and/or cryoprecipitate, based on rotational thromboelastometry (ROTEM(R)). If CTex <80 sec. and A10ex >40 mm, then no blood transfusion is performed; when CTex >80s, then fresh frozen plasma is administered (dose: 10 mL/Kg); and/or A10ex <40 mm or A10fib >10 mm, random or aphaeresis platelets are administered (01 unit/Kg or 01 aphaeresis); and/or A10ex <40 mm or A10fib <10 mm, cryoprecipitate is administered (dose: 01 unit/Kg).
16079569|NCT02311985|Other|Restrictive strategy|The interventions for this protocol include transfusion of fresh frozen plasma and/or platelets (random or aphaeresis), based on INR and platelet count. If INR >5, fresh frozen plasma is administered (dose: 10 mL/Kg); and/or platelets <25,000/microliter, random or aphaeresis platelets are administered (01 unit/Kg or 01 aphaeresis).
16079570|NCT02311972|Device|Philips InnerSense Esophageal Temperature Sensor/Feeding Tube|
16079571|NCT02311972|Device|Standard of care feeding tube|
16079572|NCT02311959|Procedure|Nipple sparing mastectomy|"Standardized surgical procedure by :
~Nipple sparing mastectomy with nipple core histopathology.
~Immediate breast reconstruction (flap and/or implant).
~+/- lymph node evaluation (sentinel node procedure or axillary dissection)."
16079573|NCT02311946|Drug|Palbociclib Alone|In Period 1 of each Cohort, a single 125 mg dose of palbociclib will be administered alone in a fasted state, and subjects will undergo serial pharmacokinetic blood sampling for up to 120 hours post-dose.
16079574|NCT02311946|Drug|Palbociclib + Rabeprazole|In Period 2 of each Cohort, subjects will receive daily 40 mg oral doses of the proton pump inhibitor rabeprazole on 7 consecutive days. Approximately 4 hours after the last rabeprazole dose a single 125 mg dose of palbociclib will be administered alone in a fasted state, and subjects will undergo serial pharmacokinetic blood sampling for up to 120 hours post-dose.
16079575|NCT02311933|Drug|Endoxifen Hydrochloride|Given PO
16079576|NCT02311933|Other|Laboratory Biomarker Analysis|Correlative studies
16079577|NCT02311933|Other|Pharmacological Study|Correlative studies
16079578|NCT02311933|Drug|Tamoxifen Citrate|Given PO
16079579|NCT02311920|Biological|Ipilimumab|Given IV
16079580|NCT02311920|Other|Laboratory Biomarker Analysis|Correlative studies
16079581|NCT02311920|Biological|Nivolumab|Given IV
16079582|NCT02311920|Drug|Temozolomide|Given PO
16079583|NCT02311907|Drug|Carboplatin|Given IV, over 30 minutes per planned chemotherapy regimen
16079584|NCT02311907|Drug|Glutathione|Given IV, over 15 minutes, immediately before chemotherapy administration
16079585|NCT02311907|Other|Laboratory Biomarker Analysis|Correlative studies
16079586|NCT02311907|Drug|Paclitaxel|Given IV, over 1 or 3 hours, per planned chemotherapy regimen
16079587|NCT02311907|Other|Placebo|Given IV
16079588|NCT02311907|Other|Quality-of-Life Assessment|Ancillary studies
16079589|NCT02311894|Drug|Somatropin|Somatropin will be administered as SC injections at a dose of up to 0.043 mg/kg/day. The dose may be adjusted for a change in body weight of at least (plus [+]/minus [-]) 2 kilograms (kg) from baseline at the Month 6 study visit or for a change in insulin-growth factor-1 (IGF-1), as per investigator assessment.
16079590|NCT02311881|Drug|Paracetamol 1000 mg SR tablets|Two paracetamol 1000 mg SR tablets administered orally two times a day plus two placebo-matched paracetamol 665 mg SR tablets administered orally three times a day for 12 weeks.
16079591|NCT02311881|Drug|Paracetamol 665 mg SR tablets|Two paracetamol 665 mg SR tablets administered orally three times a day plus two placebo-matched paracetamol 1000 mg SR tablets administered orally two times a day for 12 weeks.
16079592|NCT02311881|Drug|Placebo|Two placebo-matched paracetamol 665 mg SR tablets administered orally three times a day plus two placebo-matched paracetamol 1000 mg SR tablets administered orally two times a day for 12 weeks.
16079593|NCT02311868|Dietary Supplement|SYNBIOTIC (Probinul neutro®)|Probinul neutro® assumed three times a day far from meals as 5 g powder packets dissolved in water. Probinul neutro® contains 5×109 Lactobacillus plantarum, 2×109 Lactobacillus casei subp. rhamnosus and 2×109 Lactobacillus gasseri, 1×109 Bifidobacterium infantis and 1×109 Bifidobacterium longum, 1×109 Lactobacillus acidophilus, 1×109 Lactobacillus salivarus and 1×109 Lactobacillus sporogenes and 5×109 Streptococcus termophilus, prebiotic inulin (2.2 g; VB Beneo Synergy 1) and 1.3 g of tapioca-resistant starch.
16079594|NCT02311868|Dietary Supplement|PLACEBO|Tapioca-resistant starch powder similar in colour, texture and taste to the symbiotic mixture, assumed three times a day far from meals as 5 g powder packets dissolved in water.
16079595|NCT02311855|Biological|Influenza vaccine|"Each participant will have a blood draw to measure the antibody titres influenza strains covered by the 2014-2015 influenza vaccine at three different time points:
~Visit 1- Baseline/prior to vaccination Visit 2- 4-6 weeks post-vaccination Visit 3- end of influenza season (April-May)
~At Visit 1, after the baseline blood draw, all participants will be vaccinated by Research staff in order to standardize the time from Baseline blood draw to vaccination. Participants aged 65 and older will be offered the extra strength version of the vaccine, which is usual care. Participants under the age of 65 will be given the usual strength vaccine. All patients will be given the intramuscular (IM) vaccine."
16079596|NCT02311829|Other|Telephone follow-up device|For patients in the DST group only: Phone calls by clinical psychologist at J 15 at 2, then every 2 months until M12.
16079597|NCT02311803|Procedure|Preservation of Denonvilliers Fascia|In this group, patients accepte L-PANP surgery without excision of Denonvilliers Fascia
16079598|NCT02311803|Procedure|Excision of Denonvilliers Fascia|In this group, patients accepte L-PANP surgery with excision of Denonvilliers Fascia
16079599|NCT02311790|Dietary Supplement|Trans-C16:1 supplement|Each volunteer will consume 3 escalating doses (120 mg/day, 240 mg/day and 480 mg/day) of trans-C16:1 enriched vegetable oil for 3 weeks each (3 doses x 3 weeks each [9 weeks total]
16079600|NCT02311790|Dietary Supplement|Cis-C16:1 supplement|Each volunteer will consume 3 escalating doses (380 mg/day, 760 mg/day and 1520 mg/day) of cis-C16:1 enriched vegetable oil for 3 weeks each (3 doses x 3 weeks each [9 weeks total]
16079601|NCT02311777|Drug|Pregabalin|Pregabalin will be given orally during preoperative period
16079602|NCT02311777|Drug|Ketamine|Ketamine will be given on the surgery day before the anesthesia induction
16079603|NCT02311777|Drug|Placebo|Placebo will be given orally during preoperative period
16079604|NCT02311764|Drug|Carboplatin|Carboplatin will be administered weekly
16079605|NCT02311751|Device|Repetitive Transcranial Magnetic Stimulation|rTMS is a non-invasive procedure involving the use of magnetic fields to stimulate nerve cells.
16079606|NCT02311738|Other|Training intensity intervention|High intensity training group describes the group performing high intensity exercise intervention. Moderate intensity training group describes the the group performing moderate exercise intervention
16079607|NCT02311725|Behavioral|aTAU + sTVi|Antidepressant treatment as usual provided by participants' primary care physician plus narrative communication, video-based intervention for improving depression in primary care patients.
16079608|NCT02311725|Behavioral|aTAU + Attention Control Videos|Antidepressant treatment as usual provided by participants' primary care physician plus videos about general mental health and well-being on the same dose and frequency as the experimental intervention.
16079609|NCT02311712|Device|Capsule sponge|Capsule sponge cytology examination coupled with H&E staining analysed for the presence of atypia and p53 immunohistochemistry
16079610|NCT02311699|Behavioral|Intervention to reduce IPV and HIV|The Ethiopian traditional coffee ceremony will be used as an entry point for a community based intervention to provide information, change behaviour around IPV and improve gender equity and intra-couple relations. The coffee ceremony is a culturally established forum for community discussion and conflict resolution and an integral part of Ethiopian life. The intervention will involve regular coffee ceremonies, during which approximately 20 members of the community will participate in education and discussions centred on gender issues, sexuality, communication and conflict resolution, HIV/AIDS and its link with violence, as well as HIV/AIDS prevention. Each coffee ceremony will be moderated by a female or male facilitator trained in participatory learning, moderation, HIV/AIDS prevention, counselling, and gender issues. The intervention will involve 14 two-hour session per group of participants.
16079611|NCT02311686|Dietary Supplement|10 g ethanol|Alcohol single oral dose
16079612|NCT02311686|Dietary Supplement|20 g ethanol|Alcohol single oral dose
16079613|NCT02311686|Dietary Supplement|40 g ethanol|Alcohol single oral dose
16079614|NCT02311686|Dietary Supplement|60 g ethanol|Alcohol single oral dose
16079615|NCT02311686|Dietary Supplement|80 g ethanol|Alcohol single oral dose
16079616|NCT02311673|Drug|RM-493|subcutaneous injection
16079617|NCT02311673|Drug|Placebo|subcutaneous injection
16079618|NCT02311660|Device|Vagus Nerve Stimulation Device|Cyberonics VNS System
16079619|NCT02311634|Device|Electrical pudendal nerve stimulation|Four sacral points are selected. The two upper points are located about 1 cm bilateral to the sacrococcygeal joint. On the upper points, a needle of 0.40 Х 100 mm is inserted perpendicularly to a depth of 80 to 90 mm to produce a sensation referred to the urethra or the anus. The locations of the two lower points are about 1 cm bilateral to the tip of the coccyx. On the lower points, a needle of 0.40 Х 100 or 125 mm is inserted obliquely towards the ischiorectal fossa to a depth of 90 to 110 mm to produce a sensation referred to the urethra. After the sensation referred to the above regions is produced, each of two pairs of electrodes from a G6805-2 Multi-Purpose Health Device is connected with the two ipsilaterally inserted needles.
16079620|NCT02311634|Device|Transvaginal ES|A neuromuscular stimulation therapy system (PHENIX USB 4，Electronic Concept Lignon Innovation, France) is used for TES
16079621|NCT02311621|Biological|Patient Derived CD171 specific CAR T cells expressing EGFRt (2nd generation T cells)|Intravenous infusion of autologous T cells transduced to express 4-1BB:zeta CD171CAR and EGFRt (2nd generation T cells)
16079622|NCT02311621|Biological|Patient Derived CD171 specific CAR T cells expressing EGFRt (3rd generation T cells)|Intravenous infusion of autologous T cells transduced to express CD28:4-1BB:zeta CD171CAR and EGFRt
16079623|NCT02311621|Biological|Patient Derived CD171 specific CAR T cells expressing EGFRt (long spacer 2nd generation T cells)|Intravenous infusion of autologous T cells transduced to express 4-1BB:zeta CD171CAR and EGFRt (long spacer 2nd generation T cells)
16079624|NCT02311608|Drug|Terlipressin|administered as a first-line medicine or as salvage
16079625|NCT02311608|Drug|Usual Dose Somatostatin/Octreotide|administered as a first-line medicine or as salvage
16079626|NCT02311608|Drug|High Dose Somatostatin/Octreotide|administered as salvage
16079627|NCT02311595|Procedure|reduced port laparoscopic distal gastrectomy|
16079759|NCT02310451|Biological|blood test|blood test to J0-M3-M6-M12
16079634|NCT02311569|Drug|Mirabegron|25 mg daily during the first week followed by 50 mg Mirabegron daily during the remaining treatment period.
16079635|NCT02311556|Device|dynamic susceptibility-weighted contrast-enhanced perfusion magnetic resonance imaging|
16079636|NCT02311543|Drug|TachoSil® patches|TachoSil® is a sterile, ready-to-use, absorbable surgical patch and consists of an equine collagen sponge coated with human fibrinogen and human thrombin.
16079637|NCT02311530|Drug|Felodipine|Extended Release Tablets, 10mg
16079638|NCT02311530|Drug|Felodipine (Plendil®)|
16079639|NCT02311517|Drug|Ropivacaine|90 patients are randomly allocated into two groups: ropivacaine group (n=45), saline group (n=40). In the ropivacaine group, ultrasound-guided serratus anterior plane block is performed with 0.4 ml/kg of 0.375% ropivacaine after induction of anesthesia. In the saline group, ultrasound-guided serratus anterior plane block is performed with 0.4 ml/kg saline after induction of anesthesia.
16079640|NCT02311517|Drug|Normal Saline|
16079641|NCT02311504|Device|OCT examination|
16079642|NCT02311491|Device|Ceramic coated orthodontic archwire|Hard ceramic coatings will reduce the sliding resistance of archwires in their brackets during orthodontic treatment procedures. The new coated archwire is expected to reduce treatment time.
16079643|NCT02311478|Device|T380A Intrauterine Copper Contraceptive|The T380A is intrauterine device (IUD) that used to prevent pregnancy. It is a soft, flexible T-shaped device made primarily of plastic and copper that is inserted into the uterus.
16079644|NCT02311465|Other|Palliative Care|"Components of the palliative care service intervention are expected to include:
~Establishment of a palliative care plan
~Care coordination by palliative care team
~Informational, patient friendly materials supporting Palliative Care
~Communication by palliative care team to all providers and teams involved in patient's care
~Systematic collection of information, including identification of surrogate or health care proxy and advance care planning
~Questionnaires capturing health related quality of life at regular intervals throughout the intervention period"
16079645|NCT02311452|Device|Peripherally Inserted Central Catheter (PICC)|Post-discharge antibiotics delivered via a PICC line.
16079646|NCT02311439|Drug|FOLFIRINOX + CRT|"Induction 4 times chemotherapy, FOLFIRINOX regimen, consisted of Oxaliplatin at a dose of 85 mg/m2 D1, 2-hour I.V + Irinotecan 180 mg/m2 D1 90-minute I.V. + Leucovorin 200 mg/m2 2- hour I.V, D1,2 + (5-FU) dosed at 400 mg/m2, administered as an intravenous bolus on day 1 and day 2, followed by a continuous intravenous infusion of 600 /m2 over a 20- hours period on day 1 and day 2. Treatment will be administered every 2 weeks. G-CSF will be administrated according to the need.
~In non-progressed cases, will be followed by consolidation concurrent radiotherapy with capecitabine 625 mg/m2 BID.
~Radiotherapy :
~A fractionated dose of 50.4Gy /28 fractions/15 MeV photon energy generated by Dual-energetic Linear Accelerator."
16079647|NCT02311426|Other|Observational study|
16079648|NCT02311413|Drug|Cat-PAD|The assigned study intervention will be administered by intradermal injection into the flexor surface of the forearm.
16079649|NCT02311413|Drug|Placebo|The assigned study intervention will be administered by intradermal injection into the flexor surface of the forearm.
16079652|NCT02311361|Biological|Durvalumab|10 mg/kg, mg intravenous (IV), every two weeks, or 1500 mg, IV, every four weeks.
16079653|NCT02311361|Biological|Tremelimumab|75 mg IV, every 4 weeks for 16 weeks
16079654|NCT02311361|Radiation|Sterostatic body radiation therapy (SBRT)|8 Gray (Gy) x 1; 5Gy x 5
16079655|NCT02311309|Other|Control|Control patients were defined as either transfusion using only pre ordered packed red blood cells or peroperative hemoglobin concentration >8 g/dL.
16079656|NCT02311309|Other|Unanticipated bleeding|Unanticipated bleeding was defined as either transfusion above the pre ordered packed red blood cells or peroperative hemoglobin concentration < 8 g/dL.
16079657|NCT02311231|Drug|bivalirudin|Will be administered as an intravenous bolus of 0.75 mg per kilogram, followed by an infusion of 1.75 mg per kilogram per hour). Bivalirudin will be administered alone or with a low dose of heparin up to 3000U heparin in lab or up to 5000 U given pre-hospital according to local practice.
16079658|NCT02311231|Drug|Heparin|Treatment with unfractionated Heparin 5000 IU/ml i.v. ,Leo Pharma, Sweden, (the control group). Heparin in the control group is administered as an intravenous or intra-arterial bolus according to local practice. A dose of 70-100 U/kg is recommended
16079659|NCT02311218|Dietary Supplement|Lactobacillus reuteri DSM 17938 and PTA 5289|Subjects in the test group are given one lozenges with Lactobacillus reuteri DSM 17938 and PTA 5289 in the morning and one in the evening
16079660|NCT02311218|Dietary Supplement|Placebo|Placebo lozenges with no Lactobacillus reuteri DSM 17938 and PTA 5289
16079661|NCT02311205|Procedure|Conventional Transarterial Chemoembolization (TACE)|On demand conventional TACE will be performed in all the patients after enrollment and can be continued until intrahepatic CR, TACE failure or consent withdrawal. Sorafenib will be started 3-7 days after the first and each subsequent TACE and stopped one day before next TACE and will be continued until sorafenib failure, consent withdrawal or condition worsening by clinical decision.
16079662|NCT02311205|Drug|sorafenib|Sorafenib will be started 3-7 days after the first and each subsequent TACE and stopped one day before next TACE and will be continued until sorafenib failure, consent withdrawal or condition worsening by clinical decision.
16079663|NCT02311192|Device|Ultrasonography B-scan|The patient's eye will be anesthetized. The ultrasound probe will then be used to obtain images by keeping the probe in light contact with the eye.
16079716|NCT02310789|Drug|Pilocarpine Nitrate 5%|Administered subcutaneously using Macroduct sweat stimulator device.
16079664|NCT02311179|Device|Prosthesis, BoneMaster-Exceed cup (Biomet)|Patients will be randomized preoperatively to 1) Exceed cup coated with hydroxyapatite deposited electrochemically (BoneMaster) or 2) Exceed cup coated without hydroxyapatite coating.
16079665|NCT02311179|Device|Prosthesis Exceed cup without HA (Biomet)|Patients will be randomized preoperatively to 1) Exceed cup coated with hydroxyapatite deposited electrochemically (BoneMaster) or 2) Exceed cup coated without hydroxyapatite coating.
16079666|NCT02311153|Device|Mallinckrodt Endotracheal Tube (ETT)|Patient is intubated for airway protection and ventilation with the Mallinckrodt ETT.
16079667|NCT02311153|Device|Laryseal Laryngeal mask airway (LMA)|Laryseal Laryngeal mask airway is used to provide airway protection and ventilation.
16079668|NCT02311140|Other|nasal lavage (routine diagnostic procedure in our centre), assessment of symptoms|
16079669|NCT02311127|Device|SecurAcath|Devices secures PICC subcutaneously and remains in place during the complete dwell time of the PICC
16079670|NCT02311127|Device|StatLock|Device secures PICC however, device has to be changed weekly
16079671|NCT02311114|Other|In Depth interview|In Depth interview will be conducted for 30-60 min using semi-structured questionnaire to assess participants experience with telehomecare program.
16079672|NCT02311114|Other|Observational fieldwork|Observational fieldwork will conducted to observe everyday routine activities related to telehomecare. May last up to 1h per observation.
16079673|NCT02311114|Other|Survey|Surveys with participants will be conducted using validated survey tools.
16079674|NCT02311101|Drug|Mitomycin C|Given intravesically
16079675|NCT02311088|Drug|Caffeine|
16079676|NCT02311088|Drug|Placebo|
16079677|NCT02311075|Biological|Blood samples|Blood samples will be performed at baseline and during endothelial stimulation by hand skin heating to quantify metabolites of NO, EETs, ET-1 and ROS
16079678|NCT02311062|Other|Eccentric hamstring exercises|Three exercises: 3 sets of 8 repetitions with 1 minute of rest between sets and 2 minutes of rest between exercises
16079679|NCT02311062|Other|Unistable exercises|Three exercises: 3 sets of 8 repetitions with 1 minute of rest between sets and 2 minutes of rest between exercises
16079680|NCT02311062|Other|Control|Only soccer training
16079681|NCT02311049|Radiation|Hypofractionation|
16079682|NCT02311036|Other|Comprehensive Rehabilitation|Comprehensive rehabilitation programs including PT, OT or ST will be done for two hour each every day and 5 days per week for 6-12 weeks. Initial assessment will be done within 3 days and the following assessment will be done 6 weeks or 12 weeks after rehabilitation intervention by physician and well-trained therapists.
16079683|NCT02311023|Other|Intermittent fasting|
16079684|NCT02311010|Drug|Advagraf|daily dose adapted according to Cyp 3A5 polymorphism
16079685|NCT02310997|Other|Umbilical Cord Blood Transplant|
16079686|NCT02310997|Drug|Cyclophosphamide|
16079687|NCT02310997|Radiation|Total body irradiation|
16079688|NCT02310997|Drug|Busulfan|
16079689|NCT02310997|Drug|Melphalan|
16079690|NCT02310997|Drug|Fludarabine|
16079691|NCT02310971|Biological|CVac|Cvac will be administered via intradermal injection, every 4 weeks for the first 3 doses and thereafter every 12 weeks for 3 additional doses for a total of 6
16079692|NCT02310958|Procedure|Laparoscopic surgical hernia repair|Laparoscopic surgical hernia repair in children
16079693|NCT02310945|Other|Physiotherapy|Individualised programme for each patient in line with current clinical guidelines. May include education, exercise (strengthening, range of motion exercise, aerobic), lifestyle advice and manual therapy
16079694|NCT02310932|Behavioral|Healthy Living Intervention|"Patients in the intervention groups will receive integrated collaborative clinic care by their physicians, a nurse case manager and consulting psychiatrists. They will also participate in 12-month community-based Healthy Living groups, in which cognitive and behavioral strategies are used to target health promoting behaviors, such as increased activity, improved diet, adherence to medical regimens, as well as problem-solving skills, coping skills, and social support."
16079695|NCT02310919|Drug|Low dose hCG plus FSH co-trigger|Low dose hCG (1,500 IU) plus FSH (450 IU) co-trigger
16079696|NCT02310919|Drug|Standard dose of hCG|Standard dose of hCG (10,000 or 5,000 IU) trigger
16079697|NCT02310906|Drug|Placebo|SRP-4053 placebo-matching solution for IV infusion.
16079698|NCT02310906|Drug|SRP-4053|SRP-4053 (golodirsen) solution for IV infusion.
16079699|NCT02310893|Behavioral|Combined Contingency Management and Peer Navigation|
16079700|NCT02310893|Behavioral|Contingency Management|
16079701|NCT02310893|Behavioral|Peer Navigation|
16079702|NCT02310867|Drug|Belatacept|This study will also test a new immunosuppressant drug called Nulojix® (belatacept) to see if it is able to prevent rejection in a hand transplant. Nulojix® (belatacept) is approved by the FDA for use in kidney transplants; however, it is investigational in this study.
16079703|NCT02310867|Procedure|Hand transplant|The purpose of this study is to see if a surgical procedure for transplantation of a hand from a deceased donor can help subjects perform daily living activities better than they are currently able to do.
16079704|NCT02310854|Procedure|ACL Repair|augmented suture of acute ACL rupture (<3 weeks after injury)
16079705|NCT02310854|Procedure|ACL reconstruction|reconstruction hamstring autograft
16079706|NCT02310841|Device|ANGELAA|Different control strategies with transfemoral prosthesis prototype ANGELAA, developed at the Sensory-Motor Systems Lab, ETH Zurich, not commercially available, only 1 device exists
16079707|NCT02310828|Drug|Acetium|Capsule for oral administration contains L-cysteine 100mg
16079708|NCT02310828|Drug|Placebo|A placebo capsule matching Acetium for oral administration.
16079709|NCT02310815|Device|ReSure Sealant|
16079710|NCT02310802|Drug|OBE001 dose 1|OBE001 dispersible tablets for single oral administration
16079711|NCT02310802|Drug|OBE001 dose 2|OBE001 dispersible tablets for single oral administration
16079712|NCT02310802|Drug|OBE001 dose 3|OBE001 dispersible tablets for single oral administration
16079713|NCT02310802|Drug|Placebo|Placebo dispersible tablets for single oral administration
16079714|NCT02310789|Drug|Ivacaftor|150mg administered orally twice daily.
16079715|NCT02310789|Drug|β-Adrenergic cocktail|Administered subcutaneously to induce sweating. Cocktail composed of atropine (280µM), isoproterenol (160µM), and aminophylline (20 mM).
16079718|NCT02310776|Device|Supine automated breast ultrasound scanner|Automated wide-field-of-view breast ultrasound volume scan performed by a sonographer and interpreted by a breast imaging radiologist.
16079719|NCT02310776|Device|High-resolution handheld breast ultrasound|Standard of care, small field-of-view 2D breast ultrasound performed and interpreted by a breast imaging radiologist
16079720|NCT02310763|Biological|PF-06252616|PF-06252616 IV Infusion, 3 dose levels (5mg/kg, 20 mg/kg and 40 mg/kg) will be investigated within each subject
16079721|NCT02310763|Drug|Placebo|
16079722|NCT02310750|Drug|PF-06700841 oral solution/suspension|Oral solution or suspension of study drug PF-06700841 (once daily or twice daily during multiple dosing periods)
16079723|NCT02310750|Other|Placebo|Matching placebo given during the single ascending and multiple dose periods
16079724|NCT02310750|Drug|PF-06700841 tablet|PF-06700841 tablet formulation administered during the bioavailability / food effect investigation
16079725|NCT02310737|Procedure|sharp incision|The fascia will be opened with a sharp scissors in cesarean section
16079726|NCT02310737|Procedure|blunt incision|Fascia distracted from the muscle tissue with a blunt maneuver in cesarean section
16079727|NCT02310724|Other|TODAY cohort|This protocol is observation only and involves no intervention, care, treatment, or management.
16079728|NCT02310711|Other|Standard of Care|"Standard of care for early stage breast cancer is breast conserving therapy at this center.
~Other concomitant standard of care treatment • Radiation therapy to the whole breast
~o 45-50 Gy delivered over 25-28 fractions with a boost to the tumor bed of 10-16 Gy delivered over 5-8 fractions"
16079729|NCT02310698|Device|contrast enhanced digital mammography (CEDM)|
16079730|NCT02310698|Device|whole breast screening ultrasound (WBUS)|
16079731|NCT02310685|Other|Comprehensive e-health wellness program|"Participants randomized to this arm will have complete access to the myhealthcheckup website equipped with online tools including health assessments with coaching modules, educational material with quizzes, exercise challenges and motivational tips. The subject will meet with the pharmacist on 4 occasions (initial, 3, 6, 12 months) to update the cardiovascular risk profile, BP, weight, waist circumference and lipid profile. All interventions that were prespecified to be administered as part of the protocol, even if a particular intervention is not of interest."
16079732|NCT02310672|Drug|Macitentan|All patients take open-label macitentan 10mg o.d.
16079733|NCT02310659|Other|No intervention|No intervention
16079734|NCT02310646|Drug|LEO 90100 Aerosol Foam|Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Aerosol Foam 60 g per can, applied once daily for one week
16079735|NCT02310646|Drug|Daivobet® gel|Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) Gel 60 g per bottle, applied once daily for one week.
16079736|NCT02310633|Behavioral|Memory Strategy Training|This intervention involves intervention that teaches participants to use active encoding strategies to learn and remember new information. The intervention will be implemented using verbal and face-name paired associate learning.
16079737|NCT02310633|Behavioral|Errorless Learning|This intervention enhances consolidation of correct target information by preventing false recall of incorrect information during the acquisition phase. Participants are encouraged to recall target information only if they are sure it is correct, thus eliminating errors. The intervention will be implemented using verbal and face-name paired associate learning.
16079738|NCT02310633|Behavioral|Retrieval Practice|This intervention enhances retrieval of correct target information by actively practicing retrieval in the presence of a cue. The intervention will be implemented using verbal and face-name paired associate learning.
16079739|NCT02310620|Behavioral|Cognitive training|regular playing with the logic games developed in the framework of the M3W (Mental Wellness Toolset) project (https://m3w-project.eu/)
16079740|NCT02310607|Other|Not an interventional study|Not an interventional study
16079741|NCT02310594|Other|cytology specimen collection procedure|Undergo blood sample collection
16079742|NCT02310594|Other|laboratory biomarker analysis|Correlative studies
16079743|NCT02310581|Drug|Buprenorphine Sublingual Spray|Buprenorphine sublingual spray delivered via single 100 μL spray
16079744|NCT02310581|Drug|Placebo|Placebo-matching buprenorphine sublingual spray delivered via single 100 μL spray
16079745|NCT02310568|Drug|PF-06372865.|Blinded PF 06372865 and matching placebo will be provided as tablets for oral administration.
16079746|NCT02310555|Procedure|Gastric bypass|
16079747|NCT02310555|Procedure|Modified gastric bypass.|
16079748|NCT02310555|Procedure|Slevee Gastrectomy|
16079749|NCT02310542|Device|MARS albumin dialysis system|
16079750|NCT02310542|Device|SPAD albumin dialysis system|
16079751|NCT02310529|Behavioral|Interpersonal Psychotherapy|"Interpersonal Psychotherapy will be delivered to Intervention group. The intervention group will be further divided into 3 groups (8 depressed mothers in each group).IPT is 12-16 week treatment, contains a supportive element, an educational element, parenting element and an interpersonal relationship element. Its goals include helping mothers feel supportive, empowered and confident about their parenting abilities, which will directly influence in reducing their depressive symptoms as well as resolution of interpersonal conflicts. Groups will assist people who have become withdrawn, isolated and disconnected.
~Intervention will be delivered by trained clinical psychologists."
16079752|NCT02310516|Device|preoperative adequate explanations about awake surgery|
16079753|NCT02310516|Other|no preoperative explanation|
16079754|NCT02310503|Procedure|Mohs surgery|A surgical technique used primarily in the treatment of skin neoplasms, especially basal cell or squamous cell carcinoma of the skin. This procedure is a microscopically controlled excision of cutaneous tumors either after fixation in vivo or after freezing the tissue. Serial examinations of fresh tissue specimens are most frequently done.
16079755|NCT02310490|Device|DermaVeil right with left side Sculptra left side|The treatment phase will consist of one to three visits at 3 week intervals during which eligible subjects will receive bilateral injections of study material in the left and right nasolabial fold wrinkles, including visits at weeks 3 and 6 for touch ups if needed
16079756|NCT02310490|Device|DermaVeil left with left side Sculptra right side|The treatment phase will consist of one to three visits at 3 week intervals during which eligible subjects will receive bilateral injections of study material in the left and right nasolabial fold wrinkles, including visits at weeks 3 and 6 for touch ups if needed
16079760|NCT02310438|Other|Therapeutic Instrumental Music Performance|The same instruments are selected and used with each participant. They are spatially arranged for them to play in their home in a way that addresses the target movement, for example elbow flexion and extension. The music therapist plays specific musical patterns live on a guitar for each exercise whilst the participant plays specific patterns on the instruments.
16079761|NCT02310425|Drug|S. boulardii|50 mg/kg twice daily
16079762|NCT02310425|Drug|Placebo|he control group (group C) did not receive S. boulardii (nor other probiotics)
16079763|NCT02310412|Biological|INTERCEPT treated platelets|
16079764|NCT02310399|Device|Nucleus ABI541 Auditory Brainstem Implant|Surgical implantation of the Nucleus ABI541 Auditory Brainstem Implant device
16079765|NCT02310386|Device|BEMER electromagnetic field therapy|To study the effects of three months electromagnetic field therapy on pain in women with fibromyalgia.
16079766|NCT02310373|Other|Nicotine free hookah smoking|Subjects will smoke waterpipe in a controlled research environment
16079767|NCT02310360|Radiation|Fallypride|
16079768|NCT02310347|Drug|dronabinol|
16079769|NCT02310347|Drug|Placebo|
16079770|NCT02310334|Other|Guided Exercise Session|Participants will be provided a pace based upon their current (estimated) physiological strain index (PSI) - a measure of thermal work strain, the time, and the distance completed already.
16079771|NCT02310334|Other|Unguided Exercise Session|Participants will be instructed to complete 5 miles within 60 minutes and finish in as cool (lower body temperature) a state as possible.
16079775|NCT02310308|Dietary Supplement|Chewing gum administration|Intervention chewing gum Each subject will be instructed to chew 1 or 2 pellets for 5 min 3 times a day (2 in the morning, 2 after the midday meal and 1 in the afternoon). Thus, the total daily intake of magnolol and honokiol in MX group will be 11.9 mg/day. The daily use of the two different chewing gums will be carried out for 12 months.
16079776|NCT02310295|Device|Laser|focal macular laser therapy
16079777|NCT02310295|Drug|Bevacizumab|Intravitreal injection of Bevacizumab
16079778|NCT02310295|Drug|Triamcinolone Acetonide|Intravitreal injection of Triamcinolone Acetonide
16079779|NCT02310282|Device|Telemedicine|In-hospital telemedicine
16079780|NCT02310269|Drug|SOM230|
16079781|NCT02310256|Other|Five plus exercise training|calf raise exercise
16079782|NCT02310243|Drug|Palbociclib|oral, once daily (125mg, 100mg or 75mg) for 21 days
16079783|NCT02310230|Device|ExSpiron Respiratory Variation Monitor|Non-invasive monitoring of minute ventilation, tidal volume, and respiratory rate.
16079784|NCT02310204|Behavioral|multidisciplinary education program|both individual and group education sessions over a 6-month period in addition to standard psoriasis care
16079785|NCT02310204|Other|standard psoriasis care alone|
16079786|NCT02310191|Procedure|Carotid stenting|Procedures will be carried out via the femoral approach following a Seldinger technique. All patients will be on long-term aspirin (100 mg/day) and a 525-mg loading dose of clopidogrel. A dose of 10 000 units unfractionated heparin will be administered at the beginning of the intervention. A cerebral protection device (FilterWire EZ™; Boston Scientific, Natick, Massachusetts, USA) will be use in all patients if possible. The type of covered stent and other specific intervention strategies will be left to the discretion of the interventional radiologists. After predilatation of the stenosis (if needed), an appropriate stent for each stenosis will be implanted and then dilated using a balloon catheter.
16079787|NCT02310178|Procedure|Bariatric surgery|all of the current bariatric surgeries are allowed in this prospective cohort study
16079788|NCT02310165|Procedure|Z-tract Insertion Technique|
16079789|NCT02310165|Procedure|Coaxial Insertion Technique|
16079790|NCT02310152|Behavioral|Parent-Based Treatment of Child and Adolescent Anxiety Disorders|Supportive Parenting for Anxious Childhood Emotions
16079791|NCT02310152|Behavioral|CBT|Cognitive Behavioral Therapy
16079792|NCT02310139|Procedure|Colonoscopy|
16079793|NCT02310126|Device|etafilcon A (multi-focal)|Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.
16079794|NCT02310126|Device|etafilcon A (sphere)|Each subject will wear the soft contact lenses for 15 minutes then remove the lenses.
16079795|NCT02310113|Other|NIRS|Measurment of skeletal muscle oxygenation by near-infrared spectroscopy
16079796|NCT02310100|Device|TactiCath Quartz treatment|
16079797|NCT02310087|Dietary Supplement|astaxanthin with vitamin E|Four tablets of 4 mg astaxanthin with 10 mg vitamin E daily, taken at once. Daily dose is 16 mg astaxanthin with 40 mg vitamin E. Continuously for three months.
16079798|NCT02310087|Other|Placebo|Four tablets of placebo daily, taken at once. Continuously for three months.
16079799|NCT02310074|Drug|Pulsatile Gonadotropin Releasing Hormone|
16079800|NCT02310074|Drug|Human chorionic gonadotropin|Human chorionic gonadotropin (hCG)
16079801|NCT02310074|Drug|Urinary Follicle-Stimulating Hormone|Urinary Follicle-Stimulating Hormone (uFSH)
16079802|NCT02310061|Procedure|Extra-vascular lung water measurements by ultrasound (LW-US)|It is widely agreed that the high prevalence of patients with LV dysfunction and heart failure and the lack of simple, non-expensive, bedside techniques that may serve to estimate and monitor parameters of central hemodynamics for guiding the prescription of ultrafiltration (UF) and drug treatment is a factor of major clinical relevance. So,in patients allocated to the active arm, nephrologists register pre- and post-dialysis US-B lines whenever considered useful for volume monitoring.
16079803|NCT02310061|Other|Standard protocol of fluid management in hemodialysis|The intervention consists in applying a standard clinical approach for monitoring/tailoring fluid excess in HD patients.
16079804|NCT02310048|Drug|MT-1303-FormA|
16079805|NCT02310048|Drug|MT-1303-FormB|
16079806|NCT02310022|Drug|Drug Omega 3|4 g (4 capsules) once a day, administered with food
16079807|NCT02310022|Drug|Drug Omega-3 Comparator|4 g (4 capsules) once a day, administered with food
16079808|NCT02310009|Drug|Anakinra (AN)|
16079809|NCT02310009|Behavioral|Exercise (EX)|
16079810|NCT02310009|Behavioral|Control (CON)|
16079811|NCT02309996|Behavioral|Supervisor Training Program|
16079812|NCT02309983|Other|Electrical Stimulation|Electrical stimulation is a rehabilitative approach that generates muscle activity by alternating leg extension and flexion even in individuals who are unable to stand or step independently. Electrical stimulation will be applied to multiple muscles of the lower limb.
16079813|NCT02309983|Other|Stand Retraining with Body Weight Support (BWS)|Locomotor training consists of (step training and stand retraining) on the treadmill, over ground training, and community ambulation. BWS will be given when a subject can not maintain his/her body weight while executing limb locomotion.
16079814|NCT02309970|Drug|acetylsalicylic acid, clopidogrel bisulfate and/or warfarin, Apixaban, Rivaroxaban, Dabigatran|subject in this group will receive oral treatment with anti platelet drug
16079815|NCT02309970|Drug|alteplase|subject in this group will receive intravenous tPA
16079816|NCT02309970|Procedure|endovascular|
16079817|NCT02309957|Device|BioMatrix CRD|
16079818|NCT02309944|Procedure|Standard Wound Closure|The standard surgical closure consists of closure of the fascia with a looped polydioxanone (PDS) suture in a running fashion either in with the use of a mass closure technique or a Smead Jones closure at the discretion of the operating surgeon, closure of the subcutaneous space if >2 cm deep, followed by staple or suture closure of the skin.
16079819|NCT02309944|Device|Prevena™ Incision Management System|At the close of surgery, the Prevena™ Incision Management System will be placed over the closed incision. It will be removed on post-operative day 2 or 3 as clinically indicated and prior to the patient's discharge from the hospital.
16079820|NCT02309931|Procedure|antiperistaltic side-to-side ileocecal anastomosis|Right laparoscopic hemicolectomy + antiperistaltic side-to-side ileocecal anastomosis
16079821|NCT02309931|Procedure|isoperistaltic side-to-side ileocecal anastomosis|Right laparoscopic hemicolectomy+isoperistaltic side-to-side ileocecal anastomosis
16079822|NCT02309918|Drug|LDV/SOF FDC|Ledipasvir/Sofosbuvir fixed dose combination (FDC) tablet (LDV 90 mg/SOF 400 mg) once daily
16079823|NCT02309905|Device|Telemedicine|Inmates of prisons having telemedicine after implementation of telemedicine
16079824|NCT02309892|Drug|L-DOS47|A treatment cycle will be 21 days, with patients receiving L DOS47 on cycle Days 1, 8, and 15 and pemetrexed/carboplatin on Day 1 of each treatment cycle.
16079825|NCT02309879|Drug|Remifentanil infusion|Patients in Remifentanil group received an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous remifentanil infusion of 0,1 mcg/kg/min.
16079826|NCT02309879|Drug|Lidocaine infusion|Patients in Lidocaine group received an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous lidocaine infusion of 3 mg/kg/hr.
16079827|NCT02309879|Drug|Magnesium sulphate infusion|Patients in Magnesium group received an intravenous bolus injection of 50 mg/kg magnesium sulphate plus an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous magnesium sulphate infusion of 15 mg/kg/hr.
16079828|NCT02309879|Drug|Magnesium sulphate and Lidocaine infusion|Patients in Magnesium and Lidocaine group received an intravenous bolus injection of 2 mg/kg lidocaine plus 50 mg/kg magnesium sulphate followed by a continuous lidocaine infusion of 3 mg/kg/hr plus 15 mg/kg/hr magnesium sulphate
16079829|NCT02309866|Genetic|Genetic testing|Genetic testing for mutations in known and novel genes underlying RP and allied diseases
16079830|NCT02309853|Other|Visual and tactile scanning training|"20 Sessions of 30 minutes with a visual and tactile scanning training in the personal, peripersonal and extrapersonal space and trunk rotation. The intervention includes visual or tactile scanning training in three different spaces and will be individually adapted to the needs of the patients.
~Visual or tactile scanning in the personal space
~Visual or tactile scanning and trunk rotation in the peripersonal space
~Visual scanning and trunk rotation in the extrapersonal space"
16079831|NCT02309853|Other|Uni-modal visual scanning training|20 sessions of 30 minutes with traditional uni-modal visual scanning training in the peripersonal space.
16079832|NCT02309840|Behavioral|choice architecture|"Place vegetables at the beginning of the lunch line.
~Place fruits in attractive bowls or trays lined with appealing fabric, and place other fruit options next to the cash registers.
~Promote fruits and vegetables with prominently displayed signage and images.
~Place white milk selection in front of sugar-sweetened milk (e.g. chocolate milk) or at eye-level."
16079833|NCT02309840|Other|Chef-enhanced meals|meals prepared by a professional chef with enhanced palatability
16079834|NCT02309827|Drug|PF-06651600 or Placebo|PF-06651600 or placebo will be administered as an extemporaneously prepared solution in each cohort.
16079835|NCT02309814|Device|eyelid motion sensor device (Hall-probe)|all volunteers will wear the eyelid motion sensor device (Hall-probe) (including the tiny magnets on the upper eyelid). a 10 minutes movie will be screened on 40 inch television screen in a 3 meters distance
16079836|NCT02309801|Dietary Supplement|Daidzin|Super-Absorbable Soy Isoflavones, LifeExtension, USA. Single oral dose of 4 capsules (containing 80 mg of daidzin-daidzein).
16079837|NCT02309801|Dietary Supplement|Alcohol|Alcohol single oral dose
16079838|NCT02309775|Other|Auriculotherapy|First cleaning of the ear is made with 70% alcohol. The seed will be stuck in the ear with an adhesive (Micropore 3M) tape. The placement, points according to Souza (1997), were: Shen Men, Sympathetic, Kidney, Subcortex, Adrenal and Cerebral. As sessions will held twice a week for a total of 10 sessions.
16079839|NCT02309762|Drug|FB825|FB825 will be supplied at a concentration of 20 mg/mL for a single dose IV injection
16079840|NCT02309762|Drug|Placebo|Solution containing no active ingredients
16079841|NCT02309749|Other|CAP|
16079842|NCT02309736|Device|ReSure Sealant|
16079843|NCT02309723|Device|Beta amyloid imaging|
16079844|NCT02309710|Device|ShangRing|ShangRing administered to males seeking medical male circumcision
16079845|NCT02309671|Drug|FE 999049|
16079846|NCT02309671|Drug|follitropin beta|
16079847|NCT02309658|Drug|gemcitabine|Patients received intravenous 500-1000 ml normal saline and antiemetic medication before chemotherapy. Treatment consisted of intravenous gemcitabine at a dose of 1000 mg/m2 diluted in 500 ml of normal saline administered over 30 minutes mg/m2 diluted in 500 ml of normal saline administered over 30 minutes on days 1 and 8, followed by cisplatin 35 mg/m2 administered over 2 hours on day 1 and 8.
16079848|NCT02309658|Drug|cisplatin|35 mg/m2 administered over 2 hours on day 1 and 8.
16079849|NCT02309658|Radiation|chemoradiation|external beam radiotherapy concomitant with weekly cisplatin 40mg/m2
16079850|NCT02309645|Biological|EVICEL® Fibrin Sealant|Subjects randomized to receive EVICEL® Fibrin Sealant (Human), a thin layer will be applied to the entire length of the suture line and the adjacent area to at least 5mm away, including all suture holes.
16079851|NCT02309645|Other|Sutures Only|Subjects randomized to Control (Additional Sutures) will receive additional dural repair sutures applied immediately to the dural suture line after randomization as deemed necessary by the surgeon.
16079852|NCT02309632|Other|Pancreatic Cancer Screening Pathway 1|Screening with imaging and biomarker testing
16079853|NCT02309632|Other|Pancreatic Cancer Screening Pathway 2|Screening with biomarker testing only
16079854|NCT02309619|Procedure|lifting of the gastric tube to the neck for gastro-esophageal anastomosis through trans-substernal or trans-esophageal bed path.|Patients with esophageal cancer (EC) will undergo minimally invasive esophagectomy and be classified into two groups according to the last step of the procedure. The gastric tube will be lifted to the neck for gastro-esophageal anastomosis through trans-substernal path in the trans-substernal group, and through trans-esophageal bed path in the trans-esophageal bed group.
16079855|NCT02309606|Other|PET scan with 5-HT receptor ligands|Interictal episodic migraine patients and healthy controls will be scanned with a 5-HT1B and a 5-HT4 receptor radioligand. Episodic migraine patients will further be scanned during a cilostazol induced migraine attack and after treatment with sumatriptan. Chronic migraine patients will be scanned with only the 5-HT4 receptor radioligand.
16079856|NCT02309593|Device|PROFEMUR® Xm Femoral Stems|THA using PROFEMUR® Xm Femoral Stems
16079857|NCT02309580|Drug|Ibrutinib|Ibrutinib will be administered once daily continuously until disease progression (confirmed by two assessments for CTCL patients only) or intolerance. The dose levels for the Phase 1 portion of the study. Either 560 mg (4 X 140 mg capsules) or 840 mg (6 X 140 mg capsules) doses will be administered. After the recommended expansion dose is established, an expansion cohort of 12 additional patients will be treated at the recommended expansion dose to further characterize the safety at that dose and to further assess preliminary efficacy
16079858|NCT02309567|Other|Blood Collection|
16079859|NCT02309554|Other|SILCS diaphragm used with ContraGel|SILCS Diaphragm (branded as CAYA countoured diaphragm) is a single-size vaginal barrier method of contraception used with each sex act, made of silicone membrane with a nylon spring. ContraGel is a clear, water soluble greaseless gel packed in a metal tube.
16079860|NCT02309554|Other|SILCS diaphragm used with 3% Nonoxynol-9|SILCS Diaphragm (branded as CAYA countoured diaphragm) is a single-size vaginal barrier method of contraception used with each sex act, made of silicone membrane with a nylon spring. 3% Nonoxynol-9 (branded as Gynol II) is clear, unscented water soluble greaseless gel packed in plastic tubes with a vaginal applicator.
16079861|NCT02309554|Other|SILCS diaphragm|SILCS Diaphragm (branded as CAYA countoured diaphragm) is a single-size vaginal barrier method of contraception used with each sex act, made of silicone membrane with a nylon spring
16079862|NCT02309541|Device|feedback canceller algorithm (Firmware)|The study consists of two phases. Phase 1: optimization of parameters of new feedback canceller algorithm. Phase 2: comparison of new and reference feedback canceller algorithms.
16079863|NCT02309528|Other|Educational computerized digital stories|computerized digital stories made by American Indians
16079864|NCT02309515|Other|Laboratory Biomarker Analysis|Correlative studies
16079865|NCT02309515|Drug|Lenalidomide|Given PO
16079866|NCT02309515|Biological|Pneumococcal 13-valent Conjugate Vaccine|Given IM
16079867|NCT02309502|Device|Green Pascal|"Single-session Barely Visible Pascal 532nm 3,000 burns 20ms Multi-spot, single session
~Number of burns: 3,000 Spot size: 400micron Duration: 0.02seconds Exposure: 100%
~Average power: 100 to 1000 mW Spot spacing: 1 burn-width apart Total number of burns: 3,000 Distribution: From the vascular arcades towards the periphery and in the four quadrants"
16079868|NCT02309502|Device|Yellow Pascal|": Single-session P-RPhS; Pascal 577nm 3000 burns 20ms Endpoint Management: 70% Number of burns: 3,000 Spot size: 400micron Duration: 0.02seconds Exposure: A barely visible burn will be aimed at for the pattern landmark burns and EndPoint Management will be set at 70% to achieve non-visible burns Average power: 100 to 1000 mW Spot spacing: 1 burn-width apart Total number of burns: 3,000 Distribution: From the vascular arcades towards the periphery and in the four quadrants"
16079869|NCT02309489|Behavioral|Partner involvement|Partner is involved in maternity care
16079870|NCT02309476|Device|PASCAL Laser, Green Laser 0.75|"Barely Visible Pascal laser grid using 532nm green wavelength, 0.75 burn-widths-apart. Intervention: macular laser grid Number of burns: Full grid 112 burns Spot size: 100micron Duration: 10 ms Exposure: barely visible burn Average power: 100 to 1000 mW Spot spacing: 0.75 burn-widths-apart Distribution: Grid"
16079871|NCT02309476|Device|PASCAL Laser, Green Laser 1|"Barely Visible Pascal laser grid using 532nm green wavelength, 1 burn-widths-apart. Intervention: macular laser grid Number of burns: Full grid 112 burns Spot size: 100micron Duration: 10 ms Exposure: barely visible burn Average power: 100 to 1000 mW Spot spacing: 0.75 burn-widths-apart Distribution: Grid"
16079872|NCT02309476|Device|PASCAL Laser, 70% Yellow Laser 0.75|"Pascal EM at 70% 577nm yellow laser grid, 0.75 burn-widths-apart Intervention: macular laser grid Number of burns: Full grid 112 burns Spot size: 100micron Duration: 10 ms Exposure: A barely visible burn will be aimed at for the Landmark burn and EndPoint Management will be set at 70% to achieve non-visible burns Average power: 100 to 1000 mW Spot spacing: 0.75 burn-widths-apart Distribution: Grid"
16079873|NCT02309476|Device|PASCAL Laser, 70% Yellow Laser 1|"Pascal EM at 70% 577nm yellow laser grid, 0.75 burn-widths-apart Intervention: macular laser grid Number of burns: Full grid 112 burns Spot size: 100micron Duration: 10 ms Exposure: A barely visible burn will be aimed at for the Landmark burn and EndPoint Management will be set at 70% to achieve non-visible burns Average power: 100 to 1000 mW Spot spacing: 1 burn-widths-apart Distribution: Grid"
16079874|NCT02309476|Device|PASCAL Laser, 40% Yellow Laser 0.75|"Pascal EM at 40% 577nm yellow laser grid, 0.75 burn-widths-apart Intervention: macular laser grid Number of burns: Full grid 112 burns Spot size: 100micron Duration: 10 ms Exposure: A barely visible burn will be aimed at for the Landmark burn and EndPoint Management will be set at 740% to achieve non-visible burns Average power: 100 to 1000 mW Spot spacing: 0.75 burn-widths-apart Distribution: Grid"
16079925|NCT02309008|Other|Vehicle|Participants will receive vehicle cream applied topically once a day for 9 days
16079875|NCT02309476|Device|PASCAL Laser, 40% Yellow Laser 1|"Pascal EM at 40% 577nm yellow laser grid, 0.75 burn-widths-apart Intervention: macular laser grid Number of burns: Full grid 112 burns Spot size: 100micron Duration: 10 ms Exposure: A barely visible burn will be aimed at for the Landmark burn and EndPoint Management will be set at 740% to achieve non-visible burns Average power: 100 to 1000 mW Spot spacing: 0.75 burn-widths-apart Distribution: Grid"
16079876|NCT02309463|Drug|Endothelin receptor antagonist therapy|
16079877|NCT02309450|Drug|.Asunaprevir, Daclatasvir and BMS - 791325|All patients will receive an all-oral HCV tritherapy with Asunaprevir (200mg), Daclatasvir (30mg) and BMS-791325 (75mg) in a fixed-dose combination (FDC) tablet, twice a day (1 tablet in the morning and 1 tablet in the evening) for 12 weeks.
16079878|NCT02309437|Drug|Oxycodone|Use oxycodone to treat patients with mild pain caused by radiation mucositis.
16079879|NCT02309437|Drug|Oxycodone|Use oxycodone to treat patients with moderate/severe pain caused by radiation mucositis.
16079880|NCT02309424|Dietary Supplement|Vinegar|0,50mmol vinegar (6% acetic acid)
16079881|NCT02309424|Other|Placebo|50 ml water
16079882|NCT02309411|Drug|Rivaroxaban (Xarelto, BAY59-7939)|With age and body-weight adjusted twice daily dosing of rivaroxaban as Oral Suspension to achieve a similar exposure as that observed in adults treated with 20 mg rivaroxaban once daily, and no other anticoagulant
16079883|NCT02309385|Drug|8% Dexamethasone Sodium Phosphate - Visulex|
16079884|NCT02309385|Drug|15% Dexamethasone Sodium Phosphate - Visulex|
16079885|NCT02309385|Drug|Prednisolone Acetate (1%) Eye Drops|
16079886|NCT02309372|Behavioral|Beating the Blues|Computerized depression treatment intervention
16079887|NCT02309359|Biological|ALX-0061|
16079888|NCT02309359|Other|Placebo|
16079889|NCT02309359|Drug|Methotrexate|Stable background dose of commercially available methotrexate (not provided by the Sponsor).
16079890|NCT02309346|Drug|Clindamycin|Use of Clindamycin 2700mg+gentamicin 240mg+ 250ml sterile saline solution i.v. once a day or Gentamcin 240mg i.v once a day, plus clindamycin 900mg i.v. 8/8 h diluted in 250ml of sterile saline solution
16079891|NCT02309320|Biological|ALX-0171|
16079892|NCT02309320|Other|Placebo|
16079893|NCT02309307|Device|Tissue Repair Device (VergenixTM STR)|Administration of Soft Tissue Repair Device
16079894|NCT02309294|Device|Novel lubricant Miami w/ fragrance|0.2 ml aliquot on occlusive patch
16079895|NCT02309294|Device|Novel lubricant Miami no fragrance|0.2 ml aliquot on occlusive patch
16079896|NCT02309294|Device|KY Liquid lubricant|0.2 ml aliquot on occlusive patch
16079897|NCT02309294|Device|Astroglide Gel lubricant|0.2 ml aliquot on occlusive patch
16079898|NCT02309294|Device|Wet Platinum lubricant|0.2 ml aliquot on occlusive patch
16079899|NCT02309281|Drug|aflibercept 2mg|Aflibercept 2mg (Eylea) is intravitreally applied. The first treatment interval with aflibercept will be 4 weeks and corresponding to the treat and extend regime intervals will be increased in 2-weeks-steps.
16079900|NCT02309255|Other|no intervention|
16079901|NCT02309242|Behavioral|Neuropsychological assessment, MRI|All subjects will be imaged (MRI) on the same 3T Philips scanner with a 32-channel phased-array head coil, located in the radiology department at UZ Leuven. For the neuropsychological assessment we will implement an extended neuropsychological assessment battery: ANT, CMS, Rey, BRIEF, WISC III, PedsQL, STAI, BDi, achenbach questionnaires
16079902|NCT02309216|Other|Whol-Body MRI scan|
16079903|NCT02309203|Device|FRED|Flow Re-Direction Endoluminal Device
16079904|NCT02309177|Drug|nab-Paclitaxel|
16079905|NCT02309177|Drug|Nivolumab|
16079906|NCT02309177|Drug|Gemcitabine|
16079907|NCT02309177|Drug|Carboplatin|
16079908|NCT02309164|Procedure|Acupuncture|10 acupuncture sessions of 30 minutes each, twice a week
16079909|NCT02309164|Behavioral|Orientation group|medical management guidelines for foot / hands care, sensory desensitization, risk prevention guidelines, proper ergonomics and orthoses when necessary.
16079910|NCT02309151|Procedure|Immediate coronary angiography|Immediate coronary angiography for out of hospital cardiac arrest patients with no signs of ST elevation on their first ECG after ROSC
16079911|NCT02309138|Diagnostic Test|Gestational diabetes screening with fasting 3 hour 100 gm|Participants receive fasting 3 hour 100 gm oral glucose tolerance test
16079912|NCT02309138|Diagnostic Test|Gestational diabetes screening with fasting 2 hour 75g|Participants receive fasting 2 hour 75 gm oral glucose tolerance test
16079913|NCT02309125|Procedure|immediate progressive loading using gingival formers|"Implant placement will be 1 mm subcrestally, and it will receive transmucosal healing using gingival former.
~The gingival former will be replaced every 2 weeks by consequent larger size gingival former (at surgery time group A will receive 2 mm height gingival former which will be swapped by,3 mm, 4 mm and the last is 5 mm)."
16079914|NCT02309125|Procedure|submerged healing|the implant placement will be 1 mm subcrestally, and it will receive unloaded healing.(submerged healing)
16079915|NCT02309112|Other|Yoga|A mind-body therapy that includes specified breathing, meditation and physical postures.
16079916|NCT02309099|Device|Cochlear Implant|Cochlear implantation used a treatment for single-sided deafness resultant of labyrinthectomy or a translabyrinthine surgical approach
16079917|NCT02309086|Biological|Autologous dendritic cells transduced with Ad encoding NS3|Patients will receive 3 different dosis of the vaccine via subcutaneous injection
16079918|NCT02309060|Behavioral|Storytelling Video Intervention (sTVi)|Narrative communication, video-based intervention for depressed primary care patients.
16079919|NCT02309034|Behavioral|Jump exercise|Land Group / Jump (LG): Will hold weekly classes of nutritional guidance and three weekly sessions of jump, for 12 weeks, divided into warm up, main aerobics and relaxation.
16079920|NCT02309034|Behavioral|Aquatic exercise|Group Water / Water aerobics (WG): Will hold weekly classes of nutritional guidance and three weekly sessions of water, for 12 weeks, divided into warm up, main aerobics and relaxation.
16079921|NCT02309034|Other|Nutritional guidance|Control Group (CG): take part only of weekly classes of nutritional guidance, in addition to a closed group on Facebook in order to encourage them and increase attention to the group.
16079922|NCT02309021|Other|Sport|
16079923|NCT02309021|Other|Non-sport activities|
16079924|NCT02309008|Drug|PAC-14028|Participants will receive PAC-14028 cream applied topically once a day for 9 days
16079926|NCT02308995|Procedure|Cystectomy using barbed sutures|A sharp transverse cortical incision was made over the endometroma using unipolar hook and a cleavage plane was developed by sharp dissection. After the identification of the cleavage plane, the entire cyst will be enucleated by means of adequate traction with a strong grasper and counter-traction maneuvers with another grasping forceps . The ovarian edges will be re-approximated by using V-Loc (Covidien, Mansfield, MA).
16079927|NCT02308995|Procedure|Cystectomy using conventional sutures|A sharp transverse cortical incision was made over the endometroma using unipolar hook and a cleavage plane was developed by sharp dissection. After the identification of the cleavage plane, the entire cyst will be enucleated by means of adequate traction with a strong grasper and counter-traction maneuvers with another grasping forceps . The ovarian edges will be re-approximated by using polyglactin 910 suture(VICRYL™.; Ethicon Inc, Sommerville, NJ) .
16079928|NCT02308995|Device|V-Loc (Covidien, Mansfield, MA)|
16079929|NCT02308995|Device|polyglactin 910 suture(VICRYL™, Ethicon Inc, Sommerville, NJ)|
16079930|NCT02308982|Drug|Immunoglobulins, Intravenous (Privigen)|
16079931|NCT02308982|Drug|Placebo|
16079932|NCT02308969|Drug|LSD|100ug per os, single dose
16079933|NCT02308969|Drug|Placebo|Capsules containing mannitol looking identical to LSD
16079934|NCT02308956|Behavioral|Integrated mental health in primary care|A task-shared model of collaborative mental health care integrated into the primary care setting.
16079935|NCT02308956|Behavioral|Psychiatric nurse-led specialist care|A centralised, psychiatric nurse-led, hospital out-patient service with outreach from project outreach workers
16079936|NCT02308930|Dietary Supplement|Vitamins + DHA supplement (Vitamins A,D, E and algal oil)|
16079937|NCT02308930|Dietary Supplement|Vitamins supplement (Vitamins A,D, E and corn oil)|
16079938|NCT02308904|Other|Blood Draw/Semen Exam|"Females:
~1. Obtain levels of LH/FSH, Estradiol, and AMH in all enrolled women. Males: We expect to enroll approximately 15 males ages 12 years and older.
~Levels of FSH/LH and testosterone will be obtained. In addition, we will examine the association of the hormone inhibin B with mean fertility measures. Inhibin B levels were shown to correlate with azospermia and could demonstrate better prediction of reproductive potential.
~Semen exam for determination of volume, sperm count, motility and sperm DNA integrity will be determined for interested adult thalassemia males (age ≥18 years and older)."
16079939|NCT02308904|Other|Retrospective data/Chart Review/Relevant Clinical Results|"1. Documentation of liver iron from SQUID or MRI. 2. Transfusion data on age at onset of regular transfusions, transfusion frequency over the previous five years, and years of chronic transfusion therapy (defined as 8 or more per year). 3. Data on cardiac iron as indicated by T2* MRI. 4. Ferritin levels.
~NTBI will be accessed using a mobilizer ligand to collect NTBI from all pools as Fe-NTA which is then measured by HPLC.
~1. Age at onset of chelation 2. Estimated periods of known or recalled non-compliance with regular chelation. 3. Listing of all chelation drugs previously used including dose and time period.
~1. Vitamins E and C, at time closest to obtaining reproductive hormone levels. 2. Measuring the ratio of reduced gluthatione (GSH) to oxidized gluthatione (GSSG).
~Assessment of time for pubertal development, assessment of menstrual history and need for treatment with gonadal hormone replacement."
16079940|NCT02308904|Other|Pituitary MRI|"MRI has been shown to demonstrate well the changes related to iron toxicity in the pituitary gland. An MRI protocol was optimized at Children's Hospital and Research Center Oakland (CHRCO) and Texas Children's Hospital. Utilizing 1.5 T clinical scanner to evaluate the iron accumulation in the anterior pituitary. The total data acquisition time is approximately 32 minutes. No sedation will be given.
~MRI data will be sent to Dr. Wang, department of Radiology, Children's Medical Center, University of Texas Southwestern Medical Center, Dallas, Texas. Quantification of R2, pituitary height and volume will be conducted."
16079941|NCT02308891|Drug|lactated Ringer's solution (vigorous hydration arm)|"Initial bolus of lactated Ringer's solution at 10mL/kg over 1 hour prior to ERCP
~Intravenous lactated Ringer's solution at a rate of 3mL/kg/h during the procedure and continued for 8 hours.
~At the end of ERCP, post-procedure bolus of lactated Ringer's solution at 10mL/Kg over 1hour"
16079942|NCT02308891|Drug|lactated Ringer's solution (standard hydration arm)|- Patients will receive lactated Ringer's solution at the start of the ERCP and the fluids will be administered at a rate of 1.5ml/kg/h during the procedure and for 8hours after ERCP.
16079943|NCT02308891|Device|endoscopic retrograde cholangiopancreatography (ERCP)|endoscopic retrograde cholangiopancreatography
16079944|NCT02308878|Behavioral|Mobile health cognitive stimulation|
16079945|NCT02308865|Other|multi disciplinary palliative care monthly consultations|multi disciplinary palliative care consultations with a doctor, a nurse, a psychologist and posibility of a physical therapist and a worship person.The primary consultation within 3 weeks inclusion and then every month at the same time that consultations onco-respiratory
16079946|NCT02308852|Device|tDCS|
16079947|NCT02308839|Device|GORE® EXCLUDER® Endoprosthesis|Endovascular therapy to treat abdominal aortic aneurysms
16079948|NCT02308826|Behavioral|Turtle Program|
16079949|NCT02308826|Behavioral|Cool Little Kids|
16079950|NCT02308813|Other|Braking and functionality|
16079951|NCT02308800|Device|Quantum™ Therapy - NPWT with Prontosan|Negative pressure wound therapy with Prontosan irrigation.
16079952|NCT02308800|Device|Quantum™ Therapy|Negative pressure wound therapy without irrigation.
16079953|NCT02308787|Device|Spectra Optia Apheresis System|Platelet Depletion
16079954|NCT02308761|Drug|RO6870810|Participants will receive RO6870810 once daily (at escalated doses) via subcutaneous injection in either 28-day cycles (continuous 28 days dosing or 21 days dosing followed by 7 days off drug) or in 21-day cycle (14 days dosing followed by 7 days off drug), until MTD is identified.
16079955|NCT02308748|Drug|Dofetilide|"8 am: Placebo
~12 pm (noon): 250 µg
~5:30 pm: 250 µg"
16079956|NCT02308748|Drug|Mexiletine|"8 am: weight x 4 mg/kg
~12 pm (noon): Same as at 8 am
~5:30 pm: Same as at 8 am"
16079957|NCT02308748|Drug|Lidocaine|"9 am : 30 µg/min per kg (loading) for 60 minutes and 10 µg/min per kg (maintenance) for 30 minutes
~2 pm: 55 µg/min per kg (loading) for 60 minutes and 20 µg/min per kg (maintenance) for 30 minutes
~7:30 pm: 52 µg/min per kg (loading) for 60 minutes and 20 µg/min per kg (maintenance) for 30 minutes"
16079958|NCT02308748|Drug|Moxifloxacin|"9 am: 5.63 mg/h per kg (loading) for 1 hour and 0.26 mg/h per kg (maintenance for 30 minutes)
~2 pm: 6.14 mg/h per kg (loading) for 1 hour and 0.49 mg/h per kg (maintenance for 30 minutes)
~7:30 pm: 2.23 mg/h per kg (loading) for 1 hour and 0.49 mg/h per kg (maintenance for 30 minutes)"
16079959|NCT02308748|Drug|Diltiazem|• 7:30 pm: 330 µg/h per kg (loading) for 60 minutes and 61 µg/h per kg (maintenance) for 30 minutes
16079960|NCT02308748|Drug|Placebo|Placebo (#2 Gelcap or IV saline)
16079961|NCT02308735|Other|N/A - No intervention|
16079962|NCT02308722|Radiation|5-fraction stereotactic body radiation therapy|"The investigators expect to need a maximum of 3 dose levels investigating dose to the area at risk of involved resection lines and to the tumour bed to assess the tolerability of SBRT in this setting.
~Patient entry will commence at level 1. There is the option to de-escalate to Level -1 should 2 or more DLTs be observed at the starting level. SBRT will not be escalated above level 3.
~Level -1:
~Tumour (PTV) 6Gy/# (total dose 30Gy). Area at risk of R1 (PTV_R) 8Gy/# (total dose 40Gy)
~Level 1:
~Tumour (PTV) 6Gy/# (total dose 30Gy). Area at risk of R1 (PTV_R) 9Gy/# (total dose 45Gy)
~Level 2:
~Tumour (PTV) 6.5Gy/# (total dose 32.5Gy). Area at risk of R1 (PTV_R) 9.5Gy/# (total dose 47.5Gy)
~Level 3:
~Tumour (PTV) 7Gy/# (total dose 35Gy). Area at risk of R1 (PTV_R) 10Gy/# (total dose 50Gy)"
16079963|NCT02308709|Radiation|Ventilation image-guided radiotherapy|Patient's treatment plan will be created and optimized to minimize the dose to highly-functional lung regions
16079964|NCT02308696|Behavioral|Peer-to-Peer Support|All three data collection sites run peer-to-peer community support programs. Core program elements include the same program objective, standard definition of who qualifies for peer-to-peer support, the mechanism by which older adults are referred for consideration for peer-support, core elements of training programs for the older adults who volunteer to provide the peer support, and monthly in-service trainings for all volunteers once trained, weekly hours that volunteers spend providing support, and provision of small stipends for volunteers.As they find their role very rewarding, there is very little peer turn-over; the vast majority of peers volunteer for years in this role, until they themselves start requiring services.
16079965|NCT02308696|Behavioral|Standard Community Services|All three data collection sites will continue to provide standard community services to the older adults that are not enrolled in the peer-to-peer support program
16079966|NCT02308683|Dietary Supplement|Moringa oleifera|12 weeks supplementation
16079967|NCT02308644|Drug|intravitreal bevacizumab injection(1.25mg)|intravitreal bevacizumab injection(1.25mg) / Sham injection
16079968|NCT02308631|Procedure|ENDOSCOPICALLY ASSISTED COLOSTOMY WITH COLOPEXY|The endoscope was manipulated until the light approached the pre-set for the use of transillumination site and puncture with the Loop Fixture II gastropexy kit
16079969|NCT02308618|Other|Traditional Immobilization|"After surgery subjects were immobilized in a plaster cast, with the ankle positioned in gravitational equinus; weight bearing was not allowed. Two weeks post-operatively, the cast was removed and the patient was immobilized with a new plaster cast, with the ankle in the same position. Four weeks post-operatively, the ankle was plastered in neutral position (i.e. with the sole of the foot perpendicular to the shank), and weight bearing was encouraged. Six weeks post-operatively, the plaster cast was removed
~The home exercise program consisted of active exercises and stretches to improve ankle range of motion, and resistance and balance exercises"
16079970|NCT02308618|Other|Early Mobilization|The physical therapy started two weeks after the surgery and lasted six weeks, during which a removable brace was used. Therapy sessions, three times per week in the six-week period, included one to two hours of exercises for regaining range of motion and muscular endurance.
16079971|NCT02308605|Device|SMARTCap|The Sarissa Biomedical SMARTCap biosensor array. This is an array of biosensors and electrodes in a simple moulded device that will fit into a vacutainer blood tube and will enable the rapid measurement of purines in freshly drawn blood. Therefore, this is not an intervention as such as the device is an In-Vitro Diagnostic Medical Device.
16079972|NCT02308592|Behavioral|Electronic Patient Decision Aid|"The electronic Patient Decision Aid (PDA) is an interactive website with 3 main sections:
~Evidence-based information on (a) depression in pregnancy, (b) each treatment option and procedure;
~(a) Evidence-based information on the risks and benefits of both untreated depression and antidepressant treatment, (b) exercises to help women determine which risks and benefits are most important to them; and
~A summary section that outlines the information reviewed and which benefits and risks they deemed most important."
16079973|NCT02308592|Behavioral|Standard Resource Sheet|"Women allocated to the control intervention will login to the study website and receive a printable PDF containing references to standard published information on antidepressant use in pregnancy. This ensures women have access to accurate information on the benefits and risks of antidepressant medication in pregnancy (even though they will not receive the PDA).
~Women who are assigned the control condition AND who are not receiving care from Women's College Hospital Reproductive Life Stages Program will receive waitlisted access to the intervention after data collected at 4 weeks post-randomization."
16079974|NCT02308566|Procedure|Minimized Extracorporeal Circulation (MECC)|This group of patients receives surgical aortic valve replacement using MECC.
16079975|NCT02308566|Procedure|Conventional Extracorporeal Circulation (CECC)|This group of patients receives surgical aortic valve replacement using CECC.
16079976|NCT02308553|Drug|Nintedanib|Nintedanib (150 mg or 200 mg BID)
16079977|NCT02308553|Drug|Nintedanib-Placebo|Placebo (150 mg or 200 mg BID)
16079978|NCT02308553|Drug|Paclitaxel|Paclitaxel as 90mg/mw infusion day 1, 8, 15 q28 (6 cycles)
16079979|NCT02308540|Biological|SIILPCV10|10-valent Pneumococcal Conjugate Vaccine (SIILPCV10) at a dosage of 2 µg for each serotype polysaccharide, except 4 µg for 6B serotype, conjugated to a carrier protein (CRM197), with adjuvant (aluminum phosphate [alum]) and preservative (thiomersal).
16079980|NCT02308540|Biological|Pneumovax 23|23-valent Pneumococcal Polysaccharide Vaccine (Pneumovax 23; MSD Pharmaceuticals) for the adult cohort.
16079981|NCT02308540|Biological|Prevenar 13|13-valent Pneumococcal Conjugate Vaccine (Prevenar 13; Pfizer-Wyeth) for the toddler and infant cohorts
16079982|NCT02308527|Drug|Bevacizumab|10mg/kg IV (in the vein) on Days 1 and 15 of a 4 week cycle, for 6 cycles or until progression
16079983|NCT02308527|Drug|Temozolomide|200mg/m2/d PO (capsule taken orally) on Days 1 to 5 of a 4 week cycle, for 6 cycles or until progression
16079984|NCT02308527|Drug|Temozolomide|100mg/m2/d PO (capsule taken orally) on Days 1 to 5 of a 3 week cycle, for 6 cycles or until progression
16079985|NCT02308527|Drug|Irinotecan|50mg/m2/d IV (in the vein) on Days 1 to 5 of a 3 week cycle, for 6 cycles or until progression
16079986|NCT02308527|Drug|Bevacizumab|15mg/kg IV (in the vein) on Day 1 of a 3 week cycle, for 6 cycles or until progression
16079987|NCT02308527|Drug|Topotecan|0.75mg/m2/d IV (in the vein) on Days 1-5 of a 4 week cycle, for 6 cycles or until progression
16079988|NCT02308527|Drug|Temozolomide|150mg/m2/d PO (capsule taken orally) on Days 1 to 5 of a 4 week cycle, for 6 cycles or until progression
16079989|NCT02308527|Drug|Dinutuximab Beta|10mg/m2/d IV (in the vein) on Days 1 to 7 of a 4 week cycle, for 6 cycles or until progression
16079990|NCT02308527|Drug|Cyclophosphamide|250mg/m2/d IV (in the vein) on Days 1 to 5 of a 4 week cycle, for 6 cycles or until progression
16079991|NCT02308514|Device|cryostimulation|pressurized cold air (-70 celsius degree) is blown on the skin surface surrounding the lateral epicondyle, creating a rapid decrease in ski temperature. In a 30-40 sec exposition, skin temperature can drop to 4 celsius degree. this rapid decrease is presumed to have a positive healing effect.
16079992|NCT02308514|Other|conservative care|manual treatment of localized tender and painful myofascial areas in the muscles surrounding the forearm and mobilization of the radial head.
16079993|NCT02308501|Drug|Lastacaft ®|
16079994|NCT02308501|Drug|Tears Naturale ® (Placebo)|
16079995|NCT02308488|Drug|Radiation|Whole breast/chest wall, level 1- III (includes Cohort A) and SCV nodes IMRT at 2.7 Gy x 15 fractions. The treatment will consist of 15 fractions, with one fraction daily for five days a week, for 3 consecutive weeks.
16079996|NCT02308475|Device|Somatom Force CT Scanner|Dynamic CT perfusion of the heart
16079997|NCT02308462|Behavioral|CHIMPS intervention|"CHIMPs intervention (Family-Intervention composed of 8 Topic-related sessions over a period of 6 month, based on the evaluated manual: a preliminary talk with the family, two sessions with the parents, one session with each child, three sessions with the family).
~The sessions are semi-structured and cover the topics illness and coping, education, family relationships and trusting attachement figures, social network and support of the Family. A detailed description of the procedure is found in the Manual (Wiegand-Grefe, Halverscheid & Plass, 2011)."
16079998|NCT02308449|Drug|Ferric carboxymaltose|Infusion of 15 mg/kg (up to maximum 1000 mg) ferric carboxymaltose in 250 mL 0.9% sodium chloride
16079999|NCT02308449|Drug|Sodium chloride (placebo)|Infusion of 250 mL 0.9% sodium chloride
16080000|NCT02308436|Device|Candida Mouthwash with Curolox™ Peptide|Prophylaxis - protection and care of teeth against caries & acidic challenges
16080001|NCT02308423|Radiation|XR of shoulder|Radiologic examination: Axial view, Axillary view and Anterior posterior view- to evaluate the level of osteoarthritis by Kellgren Lawrence score and Samilson score.
16080002|NCT02308410|Procedure|Tourniquet application during surgery|Both groups received usual care according to the orthopedic surgeons surgical preferences. One group received no tourniquet during surgery (non-tourniquet group) and the other group received a pneumatic tourniquet during surgery (tourniquet-group).
16080003|NCT02308397|Other|Normal gluten containing bread|Group 1 will begin with Normal gluten containing bread(A) and then move to bread B,C and D
16080004|NCT02308397|Other|Bread with reduced gliadins content|Group 2 will begin with Bread with reduced gliadins content (B) and then move to bread A, C and D
16080005|NCT02308397|Other|Bread with reduced ATIs content|Group 3 will begin with Bread with reduced ATIs content (C) and then move to bread A, B and D
16080006|NCT02308397|Other|Bread with reduced overall protein content|Group 4 will begin with Bread with reduced overall protein content (D) d then move to bread A, B and C
16080007|NCT02308384|Behavioral|Intervention|CME, Start-package and status mail
16080008|NCT02308371|Device|Automated Pulse Pressure Variation|Based on standard of care, the physician will give fluid as needed based on standard clinical data (heart rate, central venous pressure if available, blood pressure, urine output, physical exam, lactate level) and pulse pressure variation. PPV should be elevated consistently greater than 15 minutes before giving fluid without other symptoms of patient instability (low blood pressure, elevated lactate, tachycardia). Pulse pressure variation will be followed for 48 hours.
16080009|NCT02308345|Other|Pre-chemotherapy visit summary Video|
16080010|NCT02308332|Drug|Eviplera|switch from Atripla to emtricitabine/rilpivirine/tenofovir (Eviplera)
16080011|NCT02308319|Drug|Tenofovir disoproxil fumarate|300mg q.d. per oral
16080012|NCT02308293|Behavioral|High intensity exercise|3x30 seconds 'all out' sprints
16080013|NCT02308293|Behavioral|Lay down comfortably|rest
16080014|NCT02308280|Drug|Bortezomib following nonmyeloablative allogeneic transplant|Bortezomib 1,3 mg/m2 subcutaneously every 2 weeks for 1 year (26 injections) starting on day +120 from a non myeloablative sibling or 10/10 unrelated allogeneic transplantation
16080015|NCT02308267|Other|Lung explants|Lung explants from end-stage CF, which were obtained for a reason independent from the study in the Paris (Prof Burgel) and Leuven (Prof Dupont) centres will be analysed for pIgR and IgA expression as well as for Pseudomonas aeruginosa colonization. Some lung explants from control patients will also be obtained from the Leuven centre.
16080016|NCT02308267|Other|Sputum, nasal fluid and serum|Sputum, nasal (fluid) and serum samples from CF patients and controls patients will be collected (Leuven, Paris, Torino, Verona and Saint-Luc Brussels) for S-IgA and microbiological assays. Spontaneous sputum will be collected, while nasal fluid will be sampled through nasal lavage. Control subjects will consist of COPD patients and healthy subjects (smokers or not).
16080017|NCT02308267|Procedure|Bronchoscopy|Endobronchial biopsies (EBB) and broncho-alveolar lavage (BAL) will be sampled at the KULeuven centre (Prof Dupont) in some CF patients (homozygous for the DF508 mutation) and colonized or not with Pseudomonas aeruginosa and who must have a general anaesthesia for a reason independent from the study. In these patients, a bronchial endoscopy will be performed during narcosis to take EBB (n=8) and BAL (2x50mL). If possible, nasal and rectal biopsies will also be performed in some patients. Samples will be assessed for pIgR and IgA expression and for primary broncho-epithelial cultures (carried out at the UCL centre, Pr Pilette). Control subjects will be patients without CF and without evidence of lung disease and who are undergoing narcosis for an independent reason at the KULeuven centre.
16080018|NCT02308254|Drug|Lixisenatide|Abdominal administration
16080019|NCT02308254|Drug|Placebo|Abdominal administration
16080020|NCT02308241|Drug|Ribavirin|self-administer ribavirin 1400 mg PO BID (total dose, 2800 mg/day)
16080021|NCT02308228|Behavioral|Progressive Resistance Training|Participants will complete 14 weeks (42 sessions, 3x/week) of progressive resistance training which will consist of 8 constant load movements to train all major muscle groups bilaterally.
16080022|NCT02308228|Drug|Metformin|Participants will be randomized to receive metformin in conjunction with their strength training program.
16080023|NCT02308202|Drug|doxazosin|
16080026|NCT02308189|Behavioral|Exercise with blood flow restriction|Low load resistance exercise performed with an external pressure cuff applied over both legs or both arms during respective leg and arm exercises.
16080027|NCT02308189|Behavioral|Exercise|Low load resistance exercise performed with no external pressure cuff applied to the appendicular limbs.
16080028|NCT02308176|Behavioral|APP + health advice|health advice and reinforcement to it
16080029|NCT02308176|Behavioral|health advice|health advice
16080030|NCT02308163|Drug|Peficitinib|oral
16080031|NCT02308163|Drug|Placebo|oral
16080032|NCT02308163|Biological|Etanercept|subcutaneous injection
16080033|NCT02308150|Device|transcatheter aortic valve replacement|
16080034|NCT02308137|Drug|Domperidone|Simon-2-stage design for domperidone futility
16080038|NCT02308111|Drug|Obeticholic Acid (OCA)|"Non-cirrhotic and classified as Child-Pugh Class A: 5 mg tablet of OCA once daily titrating up to a maximum of 10 mg OCA once daily based on tolerability at 3 months for the duration of the study (majority of patients).
~Cirrhotic and classified as Child-Pugh Class B and C: 5 mg tablet of OCA once weekly for at least 3 months, subsequently titrating up to a maximum dose and frequency of 10 mg OCA twice weekly based on tolerability and biochemical response for the duration of the study."
16080039|NCT02308111|Drug|Placebo|One tablet daily (or a lower frequency depending on Child Pugh score) for the remainder of the study
16080040|NCT02308098|Drug|Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh|
16080041|NCT02308098|Drug|Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh|
16080042|NCT02308098|Drug|Symbicort Turbuhaler 320/9 ug/inhalation 4 inh|
16080043|NCT02308098|Drug|Symbicort Turbuhaler 320/9 ug/inhalation 1inh|
16080044|NCT02308098|Drug|Placebo Symbicort Turbuhaler 320/9 ug/inhalation 4 inh|
16080045|NCT02308098|Drug|Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 4 inh|
16080046|NCT02308098|Drug|Placebo Budesonide/Formoterol Easyhaler 320/9 ug/inhalation 1 inh|
16080047|NCT02308098|Drug|Placebo Symbicort Turbuhaler 320/9 ug/inhalation 1 inh|
16080048|NCT02308085|Other|Endocrine therapy interruption|"3 months wash-out between treatment interruption and pregnancy attempt. Up to 2 years interruption to allow pregnancy, delivery, breastfeeding or failure to conceive.
~Endocrine therapy resumption. Completion of full duration of endocrine therapy according to individual risk, institutional policy or patient's preference."
16080049|NCT02308072|Drug|Olaparib|50 mg, 100 mg, 150 mg or 200 mg taken twice daily (depending on dose under investigation at time of registration) on days 1-3, 1-4 or 1-5 (depending on allocation of treatment schedule) of each week of treatment.
16080050|NCT02308072|Drug|Cisplatin|35 mg/m^2 IV on day 1 of each week of treatment during radiotherapy for a total of 7 weeks (total overall dose 245 mg/m^2)
16080051|NCT02308072|Radiation|IMRT|2 Gy delivered in 35 fractions, on days 1-3, 1-4 or 1-5 each week for up to 7 weeks (total overall dose delivered 70 Gy)
16080052|NCT02308059|Other|Ultrasonographic evaluation of nerves in diabetic patients|Ultrasonographic evaluation of peripheral nerves in patients with diabetes mellitus which have peripheral neuropathy
16080053|NCT02308059|Other|Ultrasonographic evaluation of nerves of healthy volunteers|evaluation of peripheral nerves and correlated with group I
16080054|NCT02308046|Drug|Terconazole|
16080055|NCT02308046|Drug|Placebo|
16080056|NCT02308033|Drug|Metronidazole|
16080057|NCT02308033|Drug|Gel vehicle|
16080058|NCT02308020|Drug|Abemaciclib|Administered orally
16080059|NCT02308007|Drug|Terconazole|
16080060|NCT02308007|Drug|Metronidazole|
16080061|NCT02308007|Drug|Terconazole/metronidazole|
16080062|NCT02307994|Drug|75IU uFSH|
16080063|NCT02307981|Other|Training with vision teacher (visual rehabilitation)|Individually adapted training With vision teacher
16080064|NCT02307968|Other|insulin injection site|insulin injected site between inner thigh and out thigh
16080065|NCT02307955|Device|firefly|
16080066|NCT02307955|Other|Standard of care|
16080068|NCT02307916|Drug|FGF-2|The FGF-2 method of use comprises a pledget of gelatin foam with human fibroblast growth factor-2 (FGF-2) added to the pledget just before topical application to the tympanic membrane, and the use of Tisseel, a fibrin glue used for applications in ear surgery.
16080069|NCT02307916|Other|Placebo|Placebo comparator using a sterile saline solution.
16080070|NCT02307864|Drug|Tramadol HCl|Tramadol HCl 50 mg immediate release (IR) tablet administered orally.
16080071|NCT02307864|Drug|Moxifloxacin 400 mg|Moxifloxacin 400 mg tablet administered orally.
16080072|NCT02307864|Drug|Tramadol HCl Placebo|Placebo matched to tramadol HCl IR tablet administered orally.
16080073|NCT02307864|Drug|Moxifloxacin Placebo|Placebo matched to Moxifloxacin 400 mg tablet administered orally.
16080074|NCT02307851|Biological|Quadrivalent VLP Vaccine|
16080075|NCT02307851|Biological|Comparator TIV|
16080076|NCT02307838|Other|Assessments arm|Protocol required assessments not provided in standard of care
16080077|NCT02307825|Drug|Azithromycin|The drug will be taken three times a week for four months.
16080078|NCT02307825|Drug|Placebo|The placebo will be taken three times a week for four months.
16080081|NCT02307773|Drug|Case Group|Consecutively, all the participants were assigned to case group with additional 2 puffs of the 10% lidocaine spray on the tip of endoscope, same medication which was used for prior pharyngeal anesthesia, or to control group with conventional pharyngeal anesthesia without further treatment. Then we compared the primary outcome measures, such as, frequency of belching and retching of two groups.
16080082|NCT02307760|Other|Human Milk Fortifier A|Acidified concentrated liquid human milk fortifier
16080083|NCT02307760|Other|Human Milk Fortifier B|Non-acidified concentrated liquid human milk fortifier
16080084|NCT02307747|Other|blood samples|Blood samples will be collected every 4 hours during 24 h
16080085|NCT02307734|Behavioral|Quit Smoking for a Healthy Family|The experimental/intervention study arm focuses on providing smoking cessation education and support through 2 LHW outreach small group educational sessions (4-5 weeks apart) and 2 individual follow-up telephone calls to smoker and family participants separately at 2-3 weeks after each group session for a total of 4 intervention contacts over 2 months. The LHW and dyads will choose the site of sessions, such as the LHW's or a participant's home, or LHW Agency's office. Each small group session will last 90 minutes, be interactive, and involve sharing personal stories, learning using a flip chart, and setting individual goals. Each telephone call will be 15- 20 minutes to reinforce progress and provide support.
16080086|NCT02307734|Behavioral|Healthy Living|"In this comparison arm, participants will receive the same number of contacts on the same schedule and in the same format (2 small group sessions and 2 telephone calls). The comparison LHWs will receive training about Healthy Living focusing on nutrition and physical activity education. Participants will also receive the Smoking Cessation Resource Handout."
16080087|NCT02307721|Drug|Intranasal naloxone|Administer 0,1 ml 8 mg/ml naloxone intranasally, dose = 0,8 mg naloxone
16080088|NCT02307721|Drug|Intramuscular naloxone|Administer 2 mL, dose intramuscular naloxone 0,8 mg
16080089|NCT02307721|Drug|Remifentanil|Administer remifentanil intravenously by way of Target Control Infusion, Minto model at a target of 2,5 ng/ml. This to achieve a state of safe and predictable opioid influence to assess pharmacodynamic response to naloxone. After treatment of 4 participants protocol amended 22. january 2015 to reduce remifentanil target to 1,25 ng/ml in the next 4. In the last 4 participants the dose will be decided later, but not exceed 2,5 ng/ml.
16080090|NCT02307721|Device|Aptar Unidose|This is the spray device chosen, and its function in this setting (spray up side down) will be assessed by weighing the device before and after administration.
16080091|NCT02307708|Device|8° incline shoe|"Wearing inclined shoes for 6 weeks, walking 15 minutes (2 times/day).
~The shoe is inclined from front to back and from top to bottom of 8 °. This causes a controlled and an eccentric contraction during the passage.
~During the walk we will have:
~In support tardigrade : an ankle dorsiflexion with a stretching the Achilles tendon (eccentric contractions).
~In support digitigrade: plantar flexion of ankle with a muscle contraction of triceps surae (concentric contraction)."
16080092|NCT02307708|Other|kinesitherapy|Daily eccentric contraction at home and once per week for 6 weeks with the physiotherapist
16080093|NCT02307695|Drug|Saxagliptin|saxagliptin 5 mg p.o. qd, 24 week
16080094|NCT02307695|Drug|Insulin|Patients will be treated according to routine clinical practice at the discretion of the treating physician.
16080095|NCT02307682|Drug|Brolucizumab ophthalmic solution|Ophthalmic solution for IVT injection
16080096|NCT02307682|Drug|Aflibercept ophthalmic solution|Ophthalmic solution for IVT injection
16080097|NCT02307669|Behavioral|INCA feedback|The study team have developed a device which is attached to inhalers that makes an audio recording of the inhaler being used. Analysis of this audio data provides objective evidence of the time of inhaler use, technique of use and the peak inspiratory flow the patient makes each time they use their inhaler. Our preliminary experiences with the information obtained from this device indicate that adherence is poor in patients with severe asthma due to any one the following issues poor time of use, errors in handling and low peak inspiratory flow rates.
16080098|NCT02307669|Behavioral|Usual Care|"The core features of the usual care group are:
~The patient's inhaler technique will be checked using a checklist, at each visit. If there are errors these will be corrected using teach-to-goal principals.
~Adherence will be discussed and barriers to adherence addressed, using motivational interview techniques.
~Written action plans for managing asthma, based on changes in PEF and symptoms will be given.
~In follow up, medication changes in response to the above will be directed by these, as suggested by Guidelines."
16080099|NCT02307656|Drug|Atazanavir|
16080100|NCT02307656|Drug|Cobicistat|
16080101|NCT02307656|Drug|Active Pharmaceutical Ingredient|
16080102|NCT02307643|Drug|MT-1303 Low dose|
16080103|NCT02307643|Drug|MT-1303 High dose|
16080104|NCT02307630|Biological|124I-Humanized 3F8|
16080105|NCT02307604|Genetic|Tumour markers testing|
16080106|NCT02307591|Drug|Best Supportive Care|Dehydration Ringer's lactate solution or normal saline intravenously Electrolytes should be monitored at regular intervals and corrected as long as vomiting and/or diarrhoea persist Fever intravenous Paracetamol Antimicrobial treatment Prophylactic 5-days course with Ampicillin should be used Pain Paracetamol,Tramadol or Pentazocine Central nervous system disturbances If a patient is restless or confused, prescribe a light sedation utilizing Midazolam, Propofol or Ketamine, preferably in association with Diazepam or Midazolam Seizures Diazepam Vomiting antiemetic medications may provide some relief and facilitate the rehydration Dyspepsia in adults, Omeprazole Diarrhoea in adults, Loperamide Acute bleeding leading to signs of haemorrhagic shock should be treated with whole blood transfusion and supportive care. Patients haemodynamically stable should not be transfused if the Hb level is >7 mg% Septic shock intensive support care Malaria in case of positive initial test, Artesunate
16080107|NCT02307591|Drug|Best Supportive Care + Amiodarone|"This treatment will be provided to patients in the experimental arm only in addition to best supportive care scheme .
~During the first 3 days of treatment, the drug must be administered in Glucose 5% solution. Deliver through the largest possible vein inserting a long catheter (if possible a CVP line).
~Day 1. Dose: 20 mg/kg/die i.v. deliver a loading dose of 5mg/kg in the 1st hour, followed by continuous infusion during the remaining 23 hours.
~Example: 20 mg /kg of Amiodarone in 500 cc of Glucose 5%. Deliver 125 ml during the 1st hour followed by 16 ml/hour for the remaining 23 hours.
~Day 2 - Day 3. Dose: 20 mg/kg/die i.v. Continuous infusion over 24 hrs. Example: Glucose 5% 500 ml containing 20 mg/kg of Amiodarone (infusion speed = 21 ml/hour).
~Day 4 to Day 10. If no significant diarrhea and/or vomiting, shift to oral intake of Amiodarone as follows:
~Adults: 200 mg tablets, 3 times a day, according to the body weight (30mg/Kg)
~Children < 29 kg: 5 mg/kg 3 times a day"
16080158|NCT02307370|Device|Turbo-Elite Laser Catheter|Application of laser energy to remove blockage
16080159|NCT02307357|Behavioral|physical fitness tests|the subjects will perform 6 different tests to evaluate their physical fitness
16080160|NCT02307344|Dietary Supplement|Nigella Sativa|
16080108|NCT02307578|Drug|Perampanel|Perampanel will be available in 2-milligrams (mg), 4-mg and 8-mg tablets and as 0.5 milligram per milliliter (mg/mL) oral suspension. Participants will start this EAP with the dose that they were receiving at the end of their participation in Study E2007-G000-332, Study E2007-G000-311, E2007-G000-238, E2007-G000-338 or EAP E2007-G000-401. Doses of perampanel can be adjusted based on clinical judgment.
16080109|NCT02307565|Drug|Midodrine|Each arm (2) will last 30 days with a 14 day washout in between each arm. Subjects nor the investigators will know which drug (midodrine or placebo) is administered to the subject for the first arm (30 days) and the second arm (30 days). The subjects will take a pill three times a day. Each subject will return home with a blood pressure monitor and will be asked to report his/her blood pressure at least 3 times a day and complete questionnaires based on how he/she is feeling.
16080110|NCT02307565|Drug|Placebo|Each arm (2) will last 30 days with a 14 day washout in between each arm. Subjects nor the investigators will know which drug (midodrine or placebo) is administered to the subject for the first arm (30 days) and the second arm (30 days). The subjects will take a pill three times a day. Each subject will return home with a blood pressure monitor and will be asked to report his/her blood pressure at least 3 times a day and complete questionnaires based on how he/she is feeling.
16080111|NCT02307552|Device|UreScan|The TUUS Foley/catheter will be inserted into the urethra via the ultrasound visualization onto the apex prostate, and the ultrasound extended through the urethra until the bladder neck and stopped. This is recorded twice automatically, and this should take 5-10 minutes for completion, and the prostate ultrasound data stored in memory. The ultrasound/subject interaction is now complete, and the study should add 30-60 minutes to the preoperative visit. No local or general anesthesia is used. The subject will be given 500 mg of Ciprofloxacin as a preventative measure against a urinary tract infection.
16080112|NCT02307539|Procedure|Psychosocial Assessment and Care|Undergo PCPI
16080113|NCT02307539|Other|Palliative Therapy|Undergo PCPI
16080114|NCT02307539|Other|Quality-of-Life Assessment|Undergo QOL assessment
16080115|NCT02307539|Other|Questionnaire Administration|Undergo questionnaire administration
16080116|NCT02307526|Drug|Pyridostigmine Bromide|After being transferred onto a tilt table, subject will lie in a rested, supine position in which the study drug, pyridostigmine bromide will be administered at the 30 minute time point. Following the administration of the study drug, the subject will remain in the supine position for an additional 30 minutes until the tilting protocol commences.
16080117|NCT02307526|Device|Tilt table test|After 60 minutes in supine resting position, a progressive head-up tilt will be utilized in which the table will be adjusted to 15°, 25°, 35° for 5 minutes at each angle and then maintained at 45° for 45 minutes or until the subjects experiences symptoms of compromised cerebral blood flow, which include, but are not limited to, light headedness, blurry vision, dizziness and nausea.
16080118|NCT02307513|Drug|Apremilast|Tablets for oral administration
16080119|NCT02307513|Drug|Placebo|Tablets for oral administration
16080120|NCT02307500|Drug|Regorafenib|oral therapy
16080121|NCT02307487|Drug|120 mg MMC in 90ml gel|120 mg of Mitomycin C mixed with 90 ml UroGen's TC-3 gel
16080122|NCT02307487|Drug|140 mg MMC in 90ml gel|140 mg of Mitomycin C mixed with 90 ml UroGen's TC-3 gel
16080123|NCT02307487|Drug|160 mg MMC in 90ml gel|160 mg of Mitomycin C mixed with 90 ml UroGen's TC-3 gel
16080124|NCT02307487|Drug|120 mg MMC in 60ml gel|120 mg of Mitomycin C mixed with 60 ml UroGen's TC-3 gel
16080125|NCT02307487|Drug|140 mg MMC in 60ml gel|140 mg of Mitomycin C mixed with 60 ml UroGen's TC-3 gel
16080126|NCT02307487|Drug|160 mg MMC in 60ml gel|160 mg of Mitomycin C mixed with 60 ml UroGen's TC-3 gel
16080127|NCT02307474|Radiation|Stereotactic Radiosurgery|3 fractions of 16 Gy per fraction to a total dose of 48 Gy on non-consecutive day within a 10 day time span
16080128|NCT02307474|Drug|Pazopanib Hydrochloride|Given PO starting at 800mg to be systematically altered following drug related toxicities.
16080129|NCT02307461|Drug|IPI-145 (duvelisib)|High single oral dose capsule IPI-145 test formulation and IPI-145 reference formulation (capsule) high single oral dose
16080130|NCT02307461|Drug|IPI-145|Low single oral dose capsule IPI-145 test formulation and IPI-145 reference formulation (capsule) low single oral dose
16080131|NCT02307461|Drug|IPI-145|High single oral dose IPI-145 test formulation (capsule) with a high-fat meal and without food
16080132|NCT02307448|Procedure|Platelet Rich Plasma|Patients will receive weekly PRP treatments with standard of care.
16080133|NCT02307448|Procedure|Standard of Care|Patients will receive weekly standard of care.
16080134|NCT02307435|Biological|MSC|subjects are implanted with allogenic mesenchymal stem cells from umbilical cord/ bone marrow/ adipose
16080135|NCT02307422|Genetic|IL-1 Genotypes, other SNPs associated with CAD|Genotyping will be carried out by a CLIA-certified genotyping facility at ILI, Waltham MA. DNA concentrations will be adjusted to a range compatible with multiple PCR conditions. Genotyping will be accomplished by performing multiplex polymerase chain reactions (PCR) specifically targeting the surrounding sequences for the SNPs being studied. A single base extension assay will be hybridized to a 48-plex microarray plate and read on a SNPstream Genotyping System (Beckman-Coulter).
16080136|NCT02307409|Other|Sonoclot/TEG test|The Sonoclot/TEG test will be done at the study time points. Within 12 hours of presentation in the emergency department, at 72 hours, and at 7 days, or when the patient meets the study criteria for suspected or proven sepsis
16080137|NCT02307396|Drug|Olanzapine|
16080138|NCT02307396|Drug|Amisulpride|
16080139|NCT02307396|Drug|Risperidone|
16080140|NCT02307396|Drug|Haloperidol|
16080141|NCT02307396|Drug|Quetiapine|
16080142|NCT02307396|Drug|Perphenazine|
16080143|NCT02307396|Drug|Sulpiride|
16080144|NCT02307396|Drug|bromperidol|
16080145|NCT02307396|Drug|Zuclopenthixol|
16080146|NCT02307396|Drug|Thioridazine|
16080147|NCT02307396|Drug|Paliperidone|
16080148|NCT02307396|Drug|Ziprasidone|
16080149|NCT02307396|Drug|Benperidol|
16080150|NCT02307396|Drug|Fluspirilene|
16080151|NCT02307396|Drug|Pimozide|
16080152|NCT02307396|Drug|Perazine|
16080153|NCT02307396|Drug|Fluphenazine|
16080154|NCT02307396|Drug|Flupentixole|
16080155|NCT02307396|Drug|Sertindole|
16080156|NCT02307383|Drug|Lactitol|
16080157|NCT02307383|Drug|Lactobacillus|
16080161|NCT02307344|Dietary Supplement|Placebo|Capsules that contain a placebo but look like the Nigella Sativa capsules
16080162|NCT02307331|Device|Optivac|A vacuum mixing system for cement with mixing and collection under vacuum but open initial mixture of powder and monomer. Has been used since 1993 with excellent results
16080163|NCT02307331|Device|Optipac|A vacuum mixing system for cement with mixing and collection under vacuum but with a pre-packed mixing system allowing for an all closed system minimizing exposure for monomer fumes. This is a relatively new mixing system
16080164|NCT02307331|Device|Arcom (Exceed cup)|The Exceed cup is available in two type of advanced bearing polyethylene material: The first is the 'classic', long term proven ArCom, a conventional polyethylene
16080165|NCT02307331|Device|E1 (Exceed cup)|The Exceed cup is available in two type of advanced bearing polyethylene material: The new is a highly cross linked polyethylene with infusion of vitamin E1 to remove free radicals in order to reduce wear.
16080166|NCT02307331|Device|Sirius stem|A polished tapered stem
16080167|NCT02307318|Device|SoftSeal Hemostatic Pad|Use of SoftSeal hemostatic device at a transradial access site with a 4 French system with with manual pressure by compression of the ulnar artery.
16080168|NCT02307305|Drug|Duloxetine|"Phase I (preemptive): 2 hour before surgery (30mg for 1 day)
~Phase II (titration): POD#1~6 (30mg for another 6 days)
~Phase III (maintenance): POD#7~13(60mg for 7 days)
~Phase IV (tapering-1): POD#14~20 (30mg for 7 days)
~Phase V (tapering-2): POD#21~27 (30mg another every day for 7 days)"
16080169|NCT02307305|Drug|celecoxib, naproxen/esomeprazole, acetaminophen/tramadol, oxycodone/naloxone|Preemptive analgesia : celebrex, Patient controlled analgesia (postop. 28 hours), During admission : celebrex BP or vimovo BP +ultracet ER BP, targin HS, Discharge medication: celebrex BP or vimovo BP, ultracet ER BP(PRN)
16080170|NCT02307292|Device|POLARIS Peripheral Vascular Self Expanding Stent System|
16080171|NCT02307279|Device|Gelesis100|
16080172|NCT02307279|Device|placebo|
16080173|NCT02307266|Behavioral|Standard of care + supplementary education|
16080174|NCT02307266|Behavioral|Standard of care + additional visits|
16080175|NCT02307266|Behavioral|Standard of care|
16080176|NCT02307253|Device|Expect™19Flex needle (Boston Scientific Corp.,Natick,MA,USA)|EUS-guided fine needle biopsy performed through the duodenum with the Expect™ 19 Flex needle
16080177|NCT02307240|Drug|CUDC-907|CUDC-907 oral with meals.
16080178|NCT02307227|Drug|Trastuzumab|
16080179|NCT02307227|Drug|Paclitaxel|
16080180|NCT02307227|Drug|Epirubicin|
16080181|NCT02307227|Drug|Docetaxel|
16080182|NCT02307214|Other|BaroReflex Sensitivity, endothelial function measurement|no other
16080183|NCT02307201|Drug|Magnesium Sulfate|The patient will receive magnesium sulfate for 24 hours postpartum
16080184|NCT02307188|Device|Constellation Full Contact Mapping Catheter|64-electrode intracardiac mapping catheter.
16080185|NCT02307162|Drug|RPL554|Phosphodiesterase 3 and 4 Inhibitor
16080186|NCT02307162|Drug|Placebo|Dummy solution
16080187|NCT02307149|Biological|CAVATAK|CAVATAK is a preparation of CVA21
16080188|NCT02307149|Drug|Ipilimumab|Ipilimumab is a human cytotoxic T-lymphocyte antigen (CTLA-4)-blocking antibody indicated for the treatment of unresectable or metastatic melanoma
16080189|NCT02307123|Procedure|Intubation|HEMS physician prehospital intubation
16080190|NCT02307110|Other|cross-sectional observation|cross-sectional opthalmic examination
16080191|NCT02307097|Procedure|Cognitive-Behavioural Bibliotherapy|
16080192|NCT02307097|Procedure|Cognitive-Behavioural Therapy|
16080193|NCT02307097|Other|WAIT|
16080194|NCT02307084|Procedure|Ultrasound imaging of the long saphenous vein|Ultrasound imaging of the long saphenous vein from the ankle to the saphenofemoral junction. This will allow assessment of vein calibre, branches and bifurcations, presence of thrombophlebitis and distribution. The presence of a proximal deep vein thrombosis will also be assessed.
16080195|NCT02307071|Device|Cefaly Kit Arnold|Occipital neurostimulation can have a therapeutic effect in chronic migraine treatment, thus representing a possible therapeutic option in patients that do not respond to any medication.
16080196|NCT02307058|Radiation|LEAD RT|The multiparametric-MRI (MP-MRI) defined Gross Tumor Volume (GTV) will receive 12-14 Gy on the first day of treatment and then the prostate plus proximal seminal vesicles (SV), the Clinical Target Volume (CTV)1, will receive 76 Gy in 38 fractions (Fxs) at 2.0 Gy per Fx. For High Risk patients, the distal SVs may be treated to 56 Gy in 38 Fxs or full dose (CTV2), and the pelvic lymph nodes may be treated to 56 Gy in 38 Fxs (CTV3).
16080197|NCT02307058|Radiation|HEIGHT RT|The MRI defined GTV(s) will receive a higher dose per day than the CTV by dose painting. The GTV(s) will receive an absolute dose of 91.2 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 98.5 Gy in 2.0 Gy fractions. The prostate plus proximal seminal vesicles (CTV1) will receive 76 Gy in 38 fractions (Fxs) at 2.0 Gy per Fx. For High Risk patients, the distal SVs (CTV2) may be treated to 56 Gy in 38 Fxs or full dose, and the pelvic lymph nodes (CTV3) may be treated to 56 Gy in 38 Fxs.
16080198|NCT02307045|Drug|Varenicline|Stimulation of nicotinic receptors by varenicline (Champix) 1,0 mg po
16080199|NCT02307045|Drug|nicotine|Nicotine replacement therapy with transdermal patches and/or chewing gums
16080200|NCT02307019|Other|Program on specific prevention of health|The intervention will be centered in provide effective tools to manage each situation presented while a caregiver cares for patients poststroke with upper limb apraxia. Moreover, the workshops will be focused on the balance between the assistance provided by the caregiver and the improvement and the increase the autonomy and independence of the patients. Finally, we will provide skills and strategies to the caregiver for enhancing the environment adaptation of the patients.
16080201|NCT02307019|Other|Program on general prevention of health|The general health educative program will consist in an educational workshop for caregivers where they are taught the habitual guidelines to caring for patients in situation of dependency.
16080202|NCT02307006|Drug|Ceftaroline|Surgical prophylaxis
16080203|NCT02307006|Drug|Cefazolin / Vancomycin|Standard of care surgical prophylaxis
16080204|NCT02306993|Other|Healthy volunteers without SCT|Subjects will undergo bone density evaluation via dual energy x-ray absorptiometry (DEXA) scanning. Subjects will provide a sample of for testing of bone turnover markers, complete blood count, and hemoglobin electrophoresis. Subjects will provide information about their dietary calcium intake and pain burden.
16080977|NCT02301143|Drug|nab-Paclitaxel|
16080205|NCT02306993|Other|Healthy volunteers with SCT|Subjects will undergo bone density evaluation via dual energy x-ray absorptiometry (DEXA) scanning. Subjects will provide a sample of for testing of bone turnover markers, complete blood count, and hemoglobin electrophoresis. Subjects will provide information about their dietary calcium intake and pain burden.
16080206|NCT02306993|Other|Volunteers with SCD|Subjects will undergo bone density evaluation via dual energy x-ray absorptiometry (DEXA) scanning. Subjects will provide a sample of for testing of bone turnover markers, complete blood count, and hemoglobin electrophoresis. Subjects will provide information about their dietary calcium intake and pain burden.
16080207|NCT02306980|Other|Colostrum|Mother's own colostrum (0.2 ml) will be administered into the mouth of the infant every 2 hours for 48 hours.
16080208|NCT02306967|Procedure|resection of oral cancer|Oral cancer will be resected.
16080209|NCT02306967|Procedure|resection of oral cancer|Oral cancer will be resected
16080210|NCT02306954|Biological|High Dose IL-2|High Dose IL-2 is approved by the FDA for the treatment of renal cell cancer.
16080211|NCT02306954|Radiation|SBRT|Patients assigned to SBRT arm will receive two doses of SBRT at 20 Gy on the Wednesday and Friday before the Monday on which IL-2 starts.
16080212|NCT02306941|Behavioral|Internet-delivered CBT|The Internet-delivered exposure treatment is based on the well-established internet-delivered CBT-treatment for IBS in adults, adapted for adolescents with FAP/FD and their parents. Main component in the treatment is exposure for symptoms. The purpose of the treatment is to reduce fearful and anxious responses to symptoms and lessen avoidance of symptoms in the adolescents, and to teach the parents how parental behavior can influence symptoms in children as well as how to support exposure. Detailed behaviour analysis is made for each individual and instruction is given on how to gradually expose to symptoms to lessen fear for symptoms and widen the behavioral repertoire.
16080213|NCT02306928|Other|Blood draw|
16080214|NCT02306915|Drug|lipegfilgrastim|lipegfilgrastim 30 μg/kg, 60 μg/kg, 100 μg/kg
16080215|NCT02306902|Drug|fenofibrate|130mg, Capsules
16080216|NCT02306902|Drug|ANTARA® (fenofibrate)|130mg, Capsules
16080217|NCT02306889|Drug|Fenofibrate|130mg Capsules
16080218|NCT02306889|Drug|ANTARA® (fenofibrate)|130mg Capsules
16080219|NCT02306876|Drug|PF-06412562 3mg BID|PF-06412562
16080220|NCT02306876|Drug|PF-06412562 15mg BID|PF-06412562
16080221|NCT02306876|Other|Placebo|Placebo
16080222|NCT02306863|Device|vibrating chair|vibration provided via physioacoustic method
16080223|NCT02306863|Device|sham treatment|simulated whole-body vibration
16080224|NCT02306850|Drug|Pembrolizumab|At the Treatment Initiation Visit (Baseline/Day 1), subjects will begin treatment with IV pembrolizumab 200 mg infusions every 3 weeks. As in previous pembrolizumab trials, eligible subjects will receive at least 24 weeks of therapy and may receive up to 2 years of pembrolizumab therapy depending on response to treatment.
16080225|NCT02306837|Drug|Bu-CY-E|mini Bu-Cy-E as consolidation chemotherapy after autologous HSCT
16080226|NCT02306811|Drug|Vatelizumab|"Pharmaceutical form:solution for infusion
~Route of administration: intravenous"
16080227|NCT02306798|Drug|TP05|One radio-labelled tablet given to subject after a high fat and a rich in calories breakfast
16080228|NCT02306785|Drug|TP05 Coating D|One radio-labelled tablet given to subjects
16080229|NCT02306785|Drug|TP05 Coating E|One radio-labelled tablet given to subjects
16080230|NCT02306785|Drug|TP05 Coating H|One radio-labelled tablet given to subjects
16080231|NCT02306772|Drug|TP05 Coating A|One radio-labelled tablet given to subjects
16080232|NCT02306772|Drug|TP05 Coating B|One radio-labelled tablet given to subjects
16080233|NCT02306759|Drug|Ketamine|Ketamine 0.3mg/kg in 50ml normal saline, administered over 15 minutes
16080234|NCT02306759|Drug|Placebo|Normal saline 50ml, administered over 15 minutes
16080235|NCT02306746|Dietary Supplement|TARGET protocol EN 1.5 kcal/mL|Enteral feed 1.5 kcal/mL
16080236|NCT02306746|Dietary Supplement|TARGET protocol EN 1.0 kcal/mL|Enteral feed 1.0 kcal/mL
16080237|NCT02306733|Drug|Ergometrine|100 women with atonic PPH will receive Ergometrine 400µgm (Methergin® Novartis, Switzerland) slowly intravenous (iv).
16080238|NCT02306733|Drug|Oxytocin|100 women with atonic PPH will receive Oxytocin 10 IU(Syntocinon® Novartis, Switzerland) slowly intravenous. iv and group 2 will receive oxytocin
16080239|NCT02306707|Procedure|Endoscopic Mucosal Resection|
16080240|NCT02306694|Drug|Advate|Patients who are currently taking Advate as their factor replacement will be eligible for the 5-day study.
16080241|NCT02306681|Other|No treatment given|This study comprises of a two-part SAQ (Self-Assessment Questionnaire). Paired responses to SAQ1 and SAQ2 will be used to estimate the differences in the frequency of hypoglycaemic episodes between the retrospective and prospective periods.
16080242|NCT02306629|Biological|Epratuzumab sc|Active substance: Epratuzumab, Pharmaceutical form: Solution for injection, Route of Administration: Subcutaneous,
16080243|NCT02306629|Biological|Epratuzumab iv|Active substance: Epratuzumab, Pharmaceutical form: Solution for Infusion, Route of Administration: Intravenous,
16080244|NCT02306603|Procedure|Endoscopic Mucosal Resection|
16080245|NCT02306590|Dietary Supplement|Calogen|
16080246|NCT02306590|Dietary Supplement|Placebo|
16080247|NCT02306577|Drug|STRIBILD|Taking oral 1 STRIBILD tablet once a day for 48 weeks
16080248|NCT02306564|Drug|Cabergoline|given to patients at high risk for OHSS
16080249|NCT02306551|Other|Biological and psycho-social risk and resilience factors|Naturalistic study, no active intervention or exposure is administered
16080250|NCT02306525|Procedure|Arthroscopic surgery of the hip joint|Arthroscopic treatment of Femoroacetabular Impingement
16080251|NCT02306512|Procedure|H&E|Sample will be stained with H&E according to standard procedures
16080252|NCT02306512|Procedure|IHC MART-1|Samples will be stained with immunohistochemistry antibody: MART-1 according to standard procedures.
16080253|NCT02306512|Procedure|IF MART-1|Samples will be stained with immunofluorescence antibody: MART-1 according to standard procedures.
16080324|NCT02305992|Procedure|Axillary Block with 0.5% Ropivicaine|Axillary blocks are regional anesthesia techniques that are sometimes employed as an alternative to general anesthesia for surgery of the shoulder, arm, forearm, wrist and hand. In this case, ultra-sound technique will be used.
16080978|NCT02301143|Drug|Gemcitabine|
16080979|NCT02301143|Drug|Chemoradiation|
16080254|NCT02306512|Procedure|IF cocktail|The fluorescent primary antibodies may include HMB-45, SOX10, Ki-67 and MART-1. However other markers will be considered to make the most visually remarkable cocktail; these may include S-100, MiTF, lamin and nestin. Primary antibodies will be tagged with secondary antibodies labeled with fluorescent signals. A fluorescent organelle stain and/or 4',6-diamidine-2-phenylindol (DAPI) may also be used to enhance cellular architecture.
16080255|NCT02306499|Procedure|ICSI|Intracytoplasmic Sperm Injection
16080256|NCT02306486|Other|with 0,5% oxalic acid (Desenssiv SSWhite)|with 0,5% oxalic acid (Desenssiv SSWhite) , desensitizer for sensivity cervical lesions on tooth
16080257|NCT02306473|Drug|Mannitol|Subjects will be challenged with inhaled mannitol according to already approved protocols.
16080258|NCT02306447|Device|rPMS and rTMS|"rPMS Stimulation of the neck muscles in five medial-lateral movements starting from the neck: left and right trapezius and deltoid muscle, trapezius and lattissimus dorsi muslce, and over the backbone. 20 stimuli per movement with 2s inter-train interval; four repetitions for each of the five movements; the first 20 trains with a frequency of 5Hz, the second 20 trains at 20Hz; stimulation at individual comfortable level (20-30% stimulator output); round coil.
~rTMS 20Hz stimulation with 2000 stimuli over the left dorso-lateral prefrontal cortex at 110% motor threshold; followed by 1Hz stimulation with 2000 stimuli over the left temporo-parietal cortex; stimulation intensity 110% motor threshold; butterfly coil.
~For stimulation we use MagPro X100 (Medtronic, Denmark)."
16080259|NCT02306434|Behavioral|Therapy by iCBT|Internet Cognitive behavioral therapy (iCBT) is given by a psychologist in the U-CARE platform. The intervention will focus on management of childbirth related fear. This means that the participants read texts and do homework assignments instructed from an internet page. Additional resources such as pictures, animations, videos and sounds will be a part of the treatment program. A psychologist will communicate with the participants through internal text-messages and will give feed back on their home work assignments. The content of the intervention will be standard components from CBT, for example relaxation training, behavioral activation, exposure for fear related stimuli, cognitive restructuring, behavioral sleep treatment.
16080260|NCT02306434|Other|Standard care-counselling|Standard care (Counselling by midwives)
16080261|NCT02306421|Procedure|RPH with the simplified Milligan-Morgan|RPH is a new therapy for hemorrhoid following the improvement of rubber band ligation. The treatment principle is: shrinkage of mucous membrane after the ligation, lift of anal cushion, the local inflammatory response resulting in adhesion of mucosa and submucosa and shallow muscle layer, anal cushion fixing to a higher position, at the same time by using the elastic contraction of automatic elastic line partly blocking blood supply of Internal hemorrhoids or reducing venous stasis, decreasing congestion hypertrophy of hemorrhoids. Simplified Milligan-Morgan is a surgical option which was improved and developed by Professor He,well-known traditional Chinese doctor from Hunan province, based on Milligan-Morgan in 1971.The operation method is simple, the operation time is shortened.
16080262|NCT02306421|Procedure|PPH with the simplified Milligan-Morgan|According to anal cushion down theory of the formation of hemorrhoids, the Italy scholar Longo pioneered a new method for the treatment of circular prolapsed internal hemorrhoids In 1998.Its principle is resection of lower rectal mucosa and submucosa of the intestinal wall tissue in the ring above the hemorrhoids through surgical staples,anastomosis of the proximal and distal mucosa , lifting and fixing down anal cushion, recovering to the normal anatomical position.Simplified Milligan-Morgan is a surgical option which was improved and developed by Professor He,well-known traditional Chinese doctor from Hunan province, based on Milligan-Morgan in 1971.The operation method is simple, the operation time is shortened.
16080263|NCT02306421|Procedure|RPH|RPH is a new therapy for hemorrhoid following the improvement of rubber band ligation.The treatment principle is: shrinkage of mucous membrane after the ligation, lift of anal cushion, the local inflammatory response resulting in adhesion of mucosa and submucosa and shallow muscle layer , anal cushion fixing to a higher position, at the same time by using the elastic contraction of automatic elastic line partly blocking blood supply of Internal hemorrhoids or reducing venous stasis, decreasing congestion hypertrophy of hemorrhoids , making hemorrhoidal lump shrink, thus eliminating bleeding and prolapse symptoms of hemorrhoid.It is suitable for internal hemorrhoids in every period and internal hemorrhoids part of mixed hemorrhoid.
16080264|NCT02306421|Procedure|PPH|According to anal cushion down theory of the formation of hemorrhoids, the Italy scholar Longo pioneered a new method for the treatment of circular prolapsed internal hemorrhoids In 1998.Its principle is resection of lower rectal mucosa and submucosa of the intestinal wall tissue in the ring above the hemorrhoids through surgical staples,anastomosis of the proximal and distal mucosa , lifting and fixing down anal cushion, recovering to the normal anatomical position
16080265|NCT02306421|Procedure|Milligan-Morgan|Milligan-Morgan surgery ,created in 1937 by Milligan etc,whose essence is to excise hemorrhoids of increasing prolapse in anatomy has good curative effect, low recurrence.It is currently the most common clinical surgery.
16080266|NCT02306395|Procedure|Endometrial local injury|The way of intervention is to scratch the uterine cavity two cycles by a small spatula in the first 3-5 days after menstrual period.
16080267|NCT02306382|Procedure|Perianal abscess drainage|The patientens will be randomly selected and after they have taken part and said yes to the study, half the group will undergo examination with ultrasound and half without. After this random selection all the patients abscess will be drained.
16080268|NCT02306382|Device|3D ultrasonography|The patientens will be randomly selected and after they have taken part and said yes to the study, half the group will undergo examination with ultrasound and half without. After this random selection all the patients abscess will be drained.
16080269|NCT02306369|Behavioral|Internetdelivered exposure-based CBT|The Internet-delivered exposure treatment is based on the well-established internet-delivered CBT-treatment for IBS in adults, and adapted for adolescents and their parents. The feasibility of the treatment were tested in a pilot study during 2012. Components in the treatment are exposure for symptoms and parent training. The purpose of the treatment is to reduce fearful and anxious responses to symptoms and lessen avoidance of symptoms in the adolescents, and to teach the parents how parental behavior can influence symptoms in children. Detailed behaviour analysis is made for each individual and instruction is given on how to gradually expose to symptoms to lessen fear for symptoms and widen the behavioral repertoire.
16080270|NCT02306356|Behavioral|Internet-delivered Cognitive Behavior Therapy|
16080372|NCT02305654|Drug|Cisplatin|Dose 15mg/m2 as part of TIP regimen (neoadjuvant chemotherapy arm) Dose 40mg/m2 for use concurrently with raditotherapy (chemoradiotherapy arm)
16080271|NCT02306343|Device|InsuPad|The InsuPad device is composed of a disposable heating pad and a reusable control unit. The heating pad is intended for one day use. The user would attach the InsuPad device to a site where insulin can be injected. When there is a need for insulin bolus injection the user would inject the insulin to a location designate for that. The device would start heating the area around the injection site without over heating the insulin. At the end of the day the subject would remove the device, dispose of the disposable unit and put the reusable unit for recharging.
16080272|NCT02306330|Device|Malditof|Malditof MS system is applied for Malditof group for identifying pathogens. It takes 20 minutes to give the results.
16080273|NCT02306330|Other|Routine clinical microbiology|Pathogens will be identified by the routine clinical microbiology of the hospital.
16080274|NCT02306317|Other|Standard procedure|FiO2 manually controlled by nursing
16080275|NCT02306317|Other|Experimental procedure|FiO2 manually controlled by parents, after training.
16080276|NCT02306304|Other|Duplex ultra sound screening for abdominal aortic aneurysms|Duplex ultra sound screening for abdominal aortic aneurysms in Israeli Arab men, smokers or past smokers at the age of 60-80 years.
16080277|NCT02306291|Drug|GMI-1271|E-selectin antagonist
16080278|NCT02306291|Drug|Mitoxantrone|induction chemotherapy
16080279|NCT02306291|Drug|Etoposide|induction chemotherapy
16080280|NCT02306291|Drug|Cytarabine|induction chemotherapy
16080281|NCT02306291|Drug|Idarubicin|induction chemotherapy
16080282|NCT02306278|Drug|gabapentin|gabapentin capsules 0.3g
16080283|NCT02306278|Drug|vitamin capsules|vitamin B
16080284|NCT02306265|Device|FFDM|2D imaging of the breast using Full-Field Digital Mammography (FFDM) device
16080285|NCT02306265|Device|DBT|3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device
16080286|NCT02306252|Other|Occupational and Physical Therapy|OT and PT will be arranged for the subject and conducted in a manner as determined by the therapist.
16080287|NCT02306239|Drug|Terlipressin|
16080288|NCT02306239|Drug|Norepinephrine|
16080289|NCT02306213|Drug|Hydroxyethylstarch 6% 130/0.4|Use of Hydroxyethylstarch intraoperatively, for cardiopulmonary bypass use and postoperatively in the intensive care unit
16080290|NCT02306213|Other|standard volume therapy|
16080291|NCT02306187|Drug|Edirol|Edirol 0.5 or 0.75ug once every day oral treatment for at least 1 year after initial visit.
16080292|NCT02306174|Behavioral|Cognitive Rehabilitation and Exposure-based Class for Compulsive Hoarding|"The group sessions consists of 20 classes, each lasting approximately 90 minutes and may consist of some or all of the following:
~A group agreement and a confidentiality contract
~Homework assignments
~Viewing informational videos about hoarding
~Behavioral experiments including sorting and discarding exercises
~Non-acquisition exposures
~This course is based on the Manual Cognitive Rehabilitation and Exposure/Sorting Therapy for Compulsive Hoarding (Ayers et al., 2014)."
16080305|NCT02306148|Other|Foot and ankle strengthening|Group will be trained during 2 months at the university by a physiotherapist and at home with a training software for foot and ankle strengthening.
16080306|NCT02306135|Other|n/a- this is an observational study|
16080307|NCT02306122|Behavioral|Pharmacist calls patient unless physician cancels call|
16080308|NCT02306122|Behavioral|Patient nonadherence information sent to physician|
16080309|NCT02306122|Behavioral|Pharmacist calls patient if physician requests call|
16080310|NCT02306122|Behavioral|Patient HMO/PPO status revealed to physician|
16080311|NCT02306109|Procedure|Standard motor rehabilitation treatment|Standard treatment: 2 sessions/week of motor rehabilitation treatment (45 minutes each one) for 10 weeks for a total of 20 sessions, including exercises for aerobic endurance, reinforcement at low load and stretching. At the end of the 20 sessions, patient and caregiver are going to continue motor activity with therapist supervision through regular follow up
16080312|NCT02306109|Procedure|Intensive motor rehabilitation treatment|Intensive treatment is characterized by an increased exercises volume: 5 sessions/week)(45 minutes each one) for 10 weeks for a total of 50 sessions, including exercises for aerobic endurance, reinforcement at low load and stretching. At the end of the 50 sessions, patient and caregiver are going to continue motor activity with therapist supervision through regular follow up
16080313|NCT02306083|Drug|Placebo three times a day|
16080314|NCT02306083|Drug|glucosamine sulfate 1500 mg three times a day|
16080315|NCT02306070|Drug|Metformin|metformin treatment + standard of care dietary and exercise advice
16080316|NCT02306070|Drug|No metformin treatment|no metformin treatment + standard of care dietary and exercise advice
16080317|NCT02306057|Procedure|Pre BCPC|Routine catheterization before surgical procedure Bidirectional CavoPulmonary Connection
16080318|NCT02306057|Procedure|Pre TCPC|Routine catheterization before surgical procedure Total CavoPulmonary Connection
16080319|NCT02306057|Procedure|BCPC surgery|Surgical procedure Bidirectional CavoPulmonary Connection
16080320|NCT02306057|Procedure|TCPC|Surgical procedure Total CavoPulmonary Connection
16080321|NCT02306031|Drug|Prescribe ARTIFICIAL TEAR|From one week before surgery, and control group received artificial tear (Sina Darou Laboratories Company, Tehran, Iran) as a placebo every 6 hours. Theses drops continued up to 6 weeks with the same dose after operations
16080322|NCT02306031|Drug|Prescribe diclofenac sodium drop 0.1%|From one week before surgery, case group received diclofenac sodium drop 0.1% (Sina Darou Laboratories Company, Tehran, Iran) every 6 hours.Theses drops continued up to 6 weeks with the same dose after operations
16080323|NCT02306018|Device|EV1000™/volumeView™|
16080980|NCT02301143|Drug|Capecitabine|
16080325|NCT02305992|Procedure|Stellate ganglion block with 0.2% Ropivicaine|A stellate ganglion block is an injection of local anesthetic in the sympathetic nerve tissue of the neck. These nerves are a part of the sympathetic nervous system. The nerves are located on either side of the voice box, in the neck
16080326|NCT02305992|Procedure|Local anesthetic infiltration with 0.25% Bupivicaine|Patients will receive local anesthetic infiltration of 0.25% Bupivicaine at the surgical site which will last approximately 6 hours.
16080327|NCT02305979|Drug|Loratadine|
16080328|NCT02305966|Procedure|surgery|All patients will receive a Delta XTEND reverse shoulder implant
16080329|NCT02305966|Device|0.8 mm diameter Tantalum marker beads|At the time of surgery, 0.8 mm diameter Tantalum marker beads will be injected into the bone surrounding the implant,
16080330|NCT02305940|Drug|Doxycycline|An oral dose of 100 mg of Doxycycline once daily, for a total duration of 52 weeks.
16080331|NCT02305940|Drug|Placebo|An oral dose of one capsule of placebo once daily, for a total duration of 52 weeks
16080332|NCT02305927|Dietary Supplement|Vitamin D3 (cholecalciferol)|Supplements containing 3,000 IU vitamin D3 taken orally once per day by the mother starting from the second trimester until 12 months postpartum
16080333|NCT02305927|Other|Placebo|Placebo supplements taken orally once per day by the mother starting from the second trimester until 12 months postpartum
16080334|NCT02305901|Drug|repaglinide|single dose on day 1 of visits 2 and 3
16080335|NCT02305901|Drug|BI 187004 tablet|multiple doses on days 8-13 of visit 2 and days 1-7 of visit 3
16080336|NCT02305901|Drug|bupropion extended release tablet|single dose on day 3 of visits 2 and 3
16080337|NCT02305888|Drug|LEO 43204|Treatment of actinic keratosis
16080338|NCT02305875|Other|MCN scoring|Mcn's distance from top of the humeral head. Mcn's distance to the catheters insertion point. Mcn's distance and position in relationship to the axillary artery.
16080339|NCT02305862|Drug|Rosuvastatin 5mg|drug intervention
16080340|NCT02305862|Drug|Rosuvastatin 20mg|drug intervention
16080341|NCT02305849|Drug|Peficitinib|oral tablet
16080342|NCT02305849|Drug|Placebo|oral tablet
16080343|NCT02305849|Drug|Methotrexate|Oral tablet/capsule
16080344|NCT02305836|Procedure|acupuncture|"For GV16, the needle in length of 25mm will be inserted obliquely and downward towards mandibular direction slowly to a depth of 0.5. And the needle will be pulled out after de qi without being retained. For Shang Yintang, GV20 and GV24, the needle will be inserted with a 30°angle to a depth of about 0.5 cun to the subperiosteum until the patients have a strong sense that the needle is being heavily pressed. For EX-HN5 and KI 4 in both sides, the needle will be outward and obliquely inserted to the same depth of 1 cun and the needle will be manipulated with an even lifting and thrusting method to make the patients feel soreness and distention. The electric stimulator will be put on GV20, GV24 and EX-HN5 in both sides with a spare-dense wave, 10/50 Hz, 0.5-5.0 mA. The current intensity will be increased until the patients can not stand."
16080345|NCT02305836|Drug|donepezil|cholinesterase inhibitors (ChE-Is)
16080346|NCT02305823|Drug|Aripiprazole|
16080347|NCT02305823|Drug|Quetiapine|
16080348|NCT02305823|Drug|Ziprasidone|
16080349|NCT02305810|Drug|Everolimus 10 mg daily|everolimus is a recently approved mTOR inhibitor in advanced progressing well/moderately differentiated pancreatic neuroendocrine tumors
16080350|NCT02305797|Drug|Extended-release lorazepam|Extended-release lorazepam capsules
16080351|NCT02305797|Drug|Placebo|Placebo capsules
16080352|NCT02305771|Device|Electroencephalography|
16080353|NCT02305771|Device|MRI|
16080354|NCT02305758|Drug|Veliparib|200 mg oral dose beginning 2 days prior to the start of FOLFIRI and continuing twice a day (BID) for a total of 7 consecutive days
16080355|NCT02305758|Drug|Placebo|200 mg oral dose beginning 2 days prior to the start of FOLFIRI and continuing twice a day (BID) for a total of 7 consecutive days
16080356|NCT02305758|Drug|Modified FOLFIRI|Irinotecan 180 mg/m^2 (90-minute infusion ± 30 minutes); leucovorin 400 mg/m^2 (90-minute infusion ± 30 minutes); and saline bolus (up to 15-minute infusion) on Day 1 of each 14-day cycle
16080357|NCT02305758|Drug|FOLFIRI|Irinotecan 180 mg/m^2 (90-minute infusion ± 30 minutes); leucovorin 400 mg/m^2 (90-minute infusion ± 30 minutes); and fluorouracil bolus 400 mg/m^2 (up to 15-minute infusion) on Day 1 of each 14-day cycle
16080358|NCT02305758|Drug|Bevacizumab|At the discretion of the Investigator, 5 mg/kg may be administered intravenously immediately preceding FOLFIRI dosing
16080359|NCT02305758|Drug|Fluorouracil infusion|2400 mg/m^2 (46-hour continuous infusion ± 4 hours) starting on Day 1 of each 14-day cycle
16080360|NCT02305745|Other|Observational|
16080361|NCT02305732|Biological|INTERCEPT Platelets|INTERCEPT platelet components (PC). Leukocyte reduced apheresis platelet components collected in Platelet Additive Solution (PAS) or 100% plasma without gamma irradiation, bacterial detection, and Cytomegalovirus (CMV) serology testing.
16080362|NCT02305706|Procedure|starting position in colonoscopy|
16080363|NCT02305693|Drug|Letrozole|
16080364|NCT02305693|Procedure|Laparoscopic ovarian drilling|
16080365|NCT02305667|Device|Macintosh|double lumen tube intubation using the Macintosh laryngoscope
16080366|NCT02305667|Device|Glidescope®|double lumen tube intubation using the Glidescope® videolaryngoscope. The distal portion of a left-sided DLT will be angulated to the right concealing the distal orifice of the tracheal lumen. The DLT will be advanced directly through the vocal cords after initial 90° clockwise rotation, the stylet will be removed, and then the DLT will be advanced gently while rotating in a 180° couterclockwise direction
16080367|NCT02305667|Device|Airtraq®|double lumen tube intubation using the Airtraq® videolaryngoscope.
16080368|NCT02305667|Device|King Vision™|double lumen tube intubation using the King Vision™ videolaryngoscope. the distal 21 cm of the left-sided DLT will be bended to replicate the curve of the non-channeled blade and the proximal curve of the DLT remains directed to the right side. Then, after initial 90° clockwise rotation, the bronchial cuff passes through the vocal cords, the stylet of the DLT will be withdrawn and the DLT will be rotated 180°counterclockwise while advancing the DLT to the desired depth.
16080369|NCT02305654|Procedure|ILND - Inguinal Lymph Node Dissection|Surgery to remove the lymph nodes in the groin near to where the cancer first appeared.
16080370|NCT02305654|Drug|Paclitaxel|Dose 175mg/m2 as part of TIP regimen.
16080371|NCT02305654|Drug|Ifosfamide|Dose 900mg/m2 as part of TIP regimen.
16080373|NCT02305654|Radiation|Intensity modulated radiation treatment (IMRT)|Treatment with very high energy X-rays (radiotherapy).
16080374|NCT02305654|Procedure|Prophylactic PLND - pelvic lymph node dissection|Surgery to remove the lymph nodes deeper in the pelvis, further away from where the cancer first appeared, that are at high risk of harbouring cancer.
16080375|NCT02305615|Other|Bevacizumab|Bevacizumab at a dose and schedule according to approved label and SmPC. The recommended dose of bevacizumab, administered as an intravenous infusion, is either 5 milligrams per kilogram (mg/kg) or 10 mg/kg of body weight given once every 2 weeks or 7.5 mg/kg or 15 mg/kg of body weight given once every 3 weeks. Bevacizumab is always used in combination with chemotherapy for the treatment of participants with metastatic CRC. It is recommended that treatment be continued until progression of the underlying disease or until unacceptable toxicity.
16080376|NCT02305615|Combination Product|Chemotherapy|Fluoropyrimidine-based doublet chemotherapy (5-Fluorouracil [5-FU] or capecitabine plus oxaliplatin or irinotecan) as first-line treatment; and continued fluoropyrimidine treatment with or without treatment modification for oxaliplatin or irinotecan, as per treating physician discretion.
16080377|NCT02305602|Biological|VentriGel|VentriGel will be injected via MyoStar catheter after NOGA mapping
16080378|NCT02305589|Drug|Sugammadex|Muscle relax reversing agent
16080379|NCT02305563|Drug|BMS-936564|
16080380|NCT02305563|Drug|Cytarabine|
16080381|NCT02305550|Device|electrical pulsed plasma discharge synthesis of nitric oxide|An NO generator was designed and developed by electrical pulsed plasma discharge nitric oxide from atmospheric nitrogen and oxygen. This generator has been fabricated by the investigators and it is not commercially available.
16080382|NCT02305537|Behavioral|McLean Anxiety Mastery Program|Cognitive-Behavioral Therapy with Exposure and Response Prevention
16080383|NCT02305524|Device|ETView VivaSight SL|Intubation using ETView VivaSight SL
16080384|NCT02305524|Device|Macintosh laryngoscope|intubation with macintosh laryngoscope with conventional tube
16080385|NCT02305511|Device|Peripheral venous catheterization|Cannulation using standard method
16080386|NCT02305511|Device|Jamshidi|intraosseous access using the Jamshidi device
16080387|NCT02305511|Device|BIG|intraosseous access using the BIG device
16080388|NCT02305511|Device|Cook|intraosseous access using the Cook device
16080389|NCT02305511|Device|EZIO|intraosseous access using the EZIO device
16080390|NCT02305498|Other|Vigorous yoga practice|
16080391|NCT02305498|Other|Restorative (gentle) yoga practice|
16080392|NCT02305485|Device|NeoVas BCS|Subjects receiving NeoVas BCS
16080393|NCT02305485|Device|XIENCE PRIME EECSS|Subjects receiving XIENCE PRIME EECSS
16080394|NCT02305472|Device|NeoVas BCS|Subjects receiving NeoVas BCS
16080395|NCT02305459|Device|Yttrium-90 loaded SIR-Spheres microspheres|Selective internal radiation therapy (SIRT), also called radioembolisation (RE), with SIR-Spheres microspheres is an endovascular procedure, included within the interventional oncologic technologies to treat primary and secondary liver tumours. Using a microcatheter, a precise dose of resin microspheres is released in the hepatic artery, where they are carried into the arterioles and selectively lodge in the tumour microvasculature. The microspheres are loaded with the radioactive yttrium-90, a high-energy beta-emitting isotope with a half-life of 64.1 hours. SIR-Spheres microspheres are manufactured by Sirtex Medical.
16080396|NCT02305459|Behavioral|QLQ-C30 with HCC module|In order to measure the palliative aspect of RE with SIR-Spheres microspheres, CIRT will incorporate a quality-of-life questionnaire. CIRT will be using EORTC's QLQ-C30 with HCC Module to measure changes in the quality of life of the patient. The quality-of-life questionnaire will be offered to the patient before the treatment, shortly after the treatment (as soon as possible) and at every follow-up. Filling out the quality-of-life questionnaire is entirely voluntary for the patient.
16080397|NCT02305446|Biological|Meningococcal (group B) multicomponent recombinant adsorbed vaccine|One dose (0.5 mL) vaccine administered by intramuscular (IM) injection in the deltoid area of the non-dominant arm.
16080398|NCT02305433|Other|Home-based physiotherapy (physical exercise)|Each physiotherapy (physical exercise) session includes muscle strength and endurance training (especially for lower limbs), balance and coordination training and functional training. Functional training includes walking exercises and ADL (activities of daily living) exercises. In addition the physiotherapist gives counseling on nutrition.
16080399|NCT02305420|Device|EmbryoGen/ BlastGen media|Embryos will be cultured in media containing Gm-CSF (EmbryoGen/ BlastGen media)
16080400|NCT02305420|Device|Standard Cook sequential media|Standard Cook IVF media will be used in the control arm
16080401|NCT02305407|Procedure|Surgical Revascularization|Most patients in this group will be performed combined procedures of superficial temporal to middle cerebral artery bypass (STA-MCA) and encephalo-duro-myo-synangiosis (EDMS). Patients not suitable for combined procedures will be performed EDMS.
16080402|NCT02305407|Other|Conservative treatment|Patients will be medically treated with antiplatelets, antiepileptics, antihypertensives and vasodilators depending on the presentation.
16080403|NCT02305394|Drug|ketamine and propofol|propofol 1.5 mg/kg and ketamine 0.3 mg/kg will be administered to participants separately by intravenous infusion.
16080404|NCT02305394|Drug|propofol and normal saline|propofol 1.5 mg/kg and normal saline [weight(kg)×0.3÷10]ml will be administered to participants separately by intravenous infusion.
16080405|NCT02305381|Drug|semaglutide|Injected subcutaneously (s.c. under the skin) once-weekly. As add-on to the pre-trial background medication.
16080406|NCT02305381|Drug|placebo|Injected subcutaneously (s.c. under the skin) once-weekly. As add-on to the pre-trial background medication.
16080407|NCT02305368|Other|Chimio-oncogramme|Cells fragment are cultured for 7 days. The effects of chemotherapy are studied on these cells through chimio-oncogramme.
16080408|NCT02305355|Drug|Omega-3-acids ethylesters 90 4g|
16080409|NCT02305355|Drug|Pravastatin, Simvastatin, Atorvastatin, Rosuvastatin|
16080410|NCT02305329|Drug|BIA 9-1067|
16080411|NCT02305316|Drug|BIA 9-1067 non-micronized|
16080412|NCT02305316|Drug|BIA 9-1067 micronized|
16080414|NCT02305290|Procedure|Endoscopic Mucosal Resection|
16080415|NCT02305277|Drug|BIA 9-1067 (clinical micronized, CM)|
16080416|NCT02305277|Drug|BIA 9-1067 (to-be-marketed, TBM)|
16080417|NCT02305264|Drug|18F-DPA-714 and 18F-FDG|"Positron emission tomography (PET) imaging following the injection of 2 radiotracers (here considered as the drugs): 1) 18F-DPA-714 ii) 18F-FDG. PET -18F-DPA-714, dose 5mCi (185MBq), will be injected via an arm intravenous catheter.
~18F-FDG , dose 5mci(185MBq), will be injected via an arm intravenous catheter."
16080418|NCT02305251|Other|Survey|Standard Gamble Survey
16080419|NCT02305238|Drug|Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)|Aflibercept 2mg is intravitreally injected.
16080420|NCT02305225|Behavioral|Sleep Deprivation|
16080421|NCT02305212|Behavioral|Cogmed|
16080422|NCT02305199|Drug|Hartmann's solution|Hartmann's solution containing 200 mg/L of calcium chloride, 300 mg/L of potassium chloride, 6 g/L of Sodium chloride, 3.1 g/L of Sodium lactate.
16080423|NCT02305199|Drug|Normal saline|Fluid containing Sodium chloride 9 g/L
16080424|NCT02305186|Drug|Pembrolizumab|Pembrolizumab administered at a dose of 200 mg IV every 3 weeks on days 1, 22, and 43 during concurrent neoadjuvant chemoradiation treatment
16080425|NCT02305186|Radiation|Neoadjuvant Chemoradiation|Chemoradiation with capecitabine (825 mg/m2 orally twice daily, Monday through Friday, on days of radiation only) and radiation (50.4 Gy in 28 fractions over 28 days)
16080426|NCT02305173|Drug|Intravenous Dexamethasone|One dose of intravenous dexamethasone (8 mg) 60 minutes before surgery.
16080427|NCT02305173|Drug|intravenous salin water|Patients of the control group received homologated placebo 60 minutes before surgery.
16080428|NCT02305160|Drug|Butantan|Use of Butantan surfactant 100 mg/kg, IT, maximum of 3 doses
16080429|NCT02305160|Drug|Control|The pulmonary surfactants commercially available in Brazil Survanta or Curosurf: 100 mg/kg, IT, maximum of 3 doses.
16080430|NCT02305147|Other|Clinical, biological and imaging followup|Assessment of motor and non motor signs every 12 months. Imaging and blood, cerebral fluid, stools and skin samples for identification of biomarkers of disease phenotype and progression.
16080431|NCT02305134|Drug|Tipepidine Hibenzate|
16080432|NCT02305134|Drug|Placebo|
16080433|NCT02305121|Device|TFNA|All investigated procedures are part of the standard of care treatment. Only the parker mobility score is study-specific. All patients included are followed up from the time point of enrollment until three months after surgery
16080434|NCT02305108|Other|fascial manipulation|"Recruited patients in study's group will be treated with the standard treatment and fascial manipulation.
~Specific points of fascial tissue will be treated with a deep friction to improve elasticity.
~The number of point treated will be refered to a specific evaluation for each patient.
~Fascial manipulation provide 3 session treatment (one treatment for week)."
16080435|NCT02305108|Other|standard treatment|"Before surgery, standard physiotherapy treatment provides an education session about the rehabilitation program tha is going to be execute after surgery.
~After surgery 2 daily physiotherapy treatment are implemented: bed exercise as active and passive flex-extension of lower limb, movements for postural change to reach sitting and standing position, walking training."
16080436|NCT02305095|Drug|FDC I/H|All subjects in both groups will be initiated on drug, FDC I/H with dose titrated up to target doses based on clinical guidelines
16080437|NCT02305082|Other|Fast-track group|Enhanced recovery after surgery pathway. Postoperatively, a set of well-defined discharge criteria will be assessed daily at 9:00 and 15:00, as well as pain, nausea, time to flatus, saturation and drain production.
16080438|NCT02305069|Drug|Pioglitazone|Described elsewhere
16080439|NCT02305069|Drug|Insulin|Administered to simulate the feeding response in study visits. Description of amount administered provided elsewhere.
16080440|NCT02305069|Drug|Octreotide|Administered to simulate the feeding response in study visits. Description of amount administered provided elsewhere.
16080441|NCT02305069|Drug|Glucose|Administered to simulate the feeding response in study visits. Description of amount administered provided elsewhere.
16080442|NCT02305069|Drug|Mixed Amino Acids|Administered to simulate the feeding response in study visits. Description of amount administered provided elsewhere.
16080443|NCT02305069|Other|[2H5]phenylalanine|Administered to allow the determination of leg protein breakdown rates in study visits. Description of amount administered provided elsewhere.
16080444|NCT02305069|Other|[1-13C]leucine|Administered to allow the determination of muscle protein synthesis rates in study visits. Description of amount administered provided elsewhere.
16080445|NCT02305056|Drug|C13 N15 Valine|C13 N15 Valine administration
16080446|NCT02305043|Other|non-interventional|non-interventional
16080447|NCT02305030|Drug|BIA 9-1067|
16080448|NCT02305030|Drug|Warfarin|
16080449|NCT02305017|Drug|BIA 9-1067|BIA 9-1067 50 mg
16080450|NCT02305017|Drug|Paracetamol|Paracetamol 1g
16080451|NCT02304991|Drug|Liquid Peanut Extract|5000mcg/ml peanut protein
16080452|NCT02304991|Drug|Placebo Glycerin SLIT|pure glycerinated saline solution with caramel coloring to match color
16080453|NCT02304978|Biological|Group CRC|blood samples
16080454|NCT02304978|Biological|Group control|Blood samples
16080455|NCT02304965|Behavioral|Daily physical activity|A combination of walking (> 10.000 steps per day) and cycling on a stationary bicycle at home at an individual intensity. For the activity walking patients need to walk at a certain speed (e.g. 3 km/h) in order to be in the range of pulsatility as obtained from their pre-training treadmill test. For cycling a defined power in watt and duration will be given to each patient as defined from the pre-training cycling test.
16080456|NCT02304952|Procedure|Radiofrequency microtenotomy|For the minimally invasive surgery will Arthrocare Topaz MicroDebrider device be used. A small incision will be made and the tip of the device is placed on surface of the tendon to structure and activated for 0.5 second, at 5 mm distance intervals on the tendon creating a grid-like pattern.
16080457|NCT02304952|Other|Eccentric exercise|Eccentric exercise for 3 months. The exercise will be performed once a day with 3 set and 5 reps, women start with 0.5 and men 1.0 kilo with a 10 % increase every week.
16080458|NCT02304952|Device|Arthrocare Topaz MicroDebrider|
16080459|NCT02304939|Procedure|changeover|
16080460|NCT02304939|Device|use of automatic infusion pump|
16080461|NCT02304939|Behavioral|datas collection|
16080462|NCT02304926|Drug|Simvastatin|simvastatin (40 mg/day) for 4 weeks
16080463|NCT02304926|Drug|Ezetimibe|ezetimibe (10 mg/day) for 4 weeks
16080981|NCT02301143|Procedure|Surgery|Surgical intervention
16080464|NCT02304926|Drug|Simvastatin + Ezetimibe|combined therapy simvastatin (40 mg/day) + ezetimibe (10 mg/day) for 4-week period
16080465|NCT02304913|Other|Hypoglossal acupuncture|
16080466|NCT02304913|Other|Sham acupuncture|
16080467|NCT02304913|Behavioral|Dietary recommendations|
16080468|NCT02304900|Other|white implant|"st intervention (in the month following the inclusion): Randomization of the color of the implant
~nd operation (1 to 3 months after the first surgery): Installation of a same color as the first implant operated eye"
16080469|NCT02304900|Other|yellow implant|"st intervention (in the month following the inclusion): Randomization of the color of the implant
~nd operation (1 to 3 months after the first surgery): Installation of a same color as the first implant operated eye"
16080470|NCT02304887|Drug|Bis, SERM Teriparatide, Denosumab|Osteoporotic drugs are assigned according to the disease severity, gender, age and so on.
16080471|NCT02304874|Other|Phlebotomy|
16080472|NCT02304861|Procedure|Viscoat|Cataract extraction surgery performed with the Alcon Infiniti VisionSystem platform. Pupils were dilated with Tropicamide 0.5% (Tropixal, Demo, Greece) and Phenylephrine Hydrochloride 5% (Phenylephrine, Cooper, Greece). Periorbital skin and the lids were cleaned and the conjuctival cul-de-sac was irrigated with povidone iodine (Betadine). Patients received topical anesthesia with propacaine hydrochloride 0.5% drops (3 drops prior to surgery). By means of a 2.75mm, superior-temporal (eleven o'clock), self-sealing, clear-cornea incision 3% Sodium Hyaluronate, 4% Chondroitin Sulfate (Viscoat, Alcon, Greece) was injected in the anterior chamber
16080473|NCT02304861|Procedure|Visthesia|Cataract extraction surgery performed with the Alcon Infiniti VisionSystem platform. Pupils were dilated with Tropicamide 0.5% (Tropixal, Demo, Greece) and Phenylephrine Hydrochloride 5% (Phenylephrine, Cooper, Greece). Periorbital skin and the lids were cleaned and the conjuctival cul-de-sac was irrigated with povidone iodine (Betadine). Patients received topical anesthesia with propacaine hydrochloride 0.5% drops (3 drops prior to surgery). By means of a 2.75mm, superior-temporal (eleven o'clock), self-sealing, clear-cornea incision sodium hyaluronate 1.5% and lidocaine hydrochloride 1% ophthalmic viscosurgical device (OVD) (Visthesia, Carl Zeiss, Germany) was injected in the anterior chamber
16080474|NCT02304848|Other|DBS (Deep Brain Stimulation)|Applying low frequency and high frequency deep brain stimulation to subthalamic nucleus.
16080475|NCT02304822|Drug|Multiple-dose of Ciprofloxacin prophylaxis|Multiple-dose prophylactic antibiotic of 200mg intravenous ciprofloxacin, 30 minutes before surgery and within 12 hours after surgery additionally
16080476|NCT02304822|Drug|Single-dose of Ciprofloxacin prophylaxis|Single-dose prophylactic antibiotic of 200mg intravenous ciprofloxacin, 30 minutes before surgery only.
16080477|NCT02304822|Drug|Zero-dose of Ciprofloxacin prophylaxis|Zero-dose of ciprofloxacin prophylaxis with none intravenous ciprofloxacin either preoperatively or postoperatively
16080478|NCT02304809|Drug|Vemurafenib|Vemurafenib is a low molecular weight, orally available, inhibitor of BRAF serine-threonine kinase. Mutations in the BRAF gene which substitute the valine at amino acid position 600 result in constitutively activated BRAF proteins, which can cause cell proliferation in the absence of growth factors that would normally be required for proliferation
16080479|NCT02304796|Behavioral|Unified Cognitive-Behavioral Therapy|"20 weekly sessions (1.5-2 hours each), based on the principles of the Unified Protocol for Trans-diagnostic Treatment of Emotional Disorders (Barlow et al., 2011) adapted for a group format.
~The treatment will include 8 different modules of varying length: motivation enhancement, understanding emotions, identifying and monitoring emotions, emotional awareness training, cognitive appraisal and reappraisal, emotional avoidance, emotion driven behaviors, awareness and tolerance of bodily sensations, relapse prevention."
16080480|NCT02304796|Behavioral|Combined Cognitive-Behavioral and Dance/Movement Therapy|20 weekly sessions (1.5-2 hours each), based on combined cognitive-behavioral techniques (psychoeducation, awareness and tolerance of emotions, interoceptive exposures, in-vivo exposures, cognitive flexibility) and dance/movement techniques.
16080481|NCT02304783|Drug|Piroxicam|Patients allocated to this arm received, as a second line treatment of renal colics, a five days treatment with 20 mg piroxicam per day and were contacted at the seventh day by telephone call to investigate the efficacity and the side effects of the treatment.
16080482|NCT02304783|Drug|Placebo|Patients allocated to this arm received a five days treatment with Placebo and were contacted at the seventh day by telephone call to investigate the efficacity and the side effects of the treatment.
16080483|NCT02304783|Drug|paracetamol|Patients allocated to this arm received a five days treatment with Paracetamol and were contacted at the seventh day by telephone call to investigate the efficacity and the side effects of the treatment.
16080484|NCT02304770|Drug|Aminolaevulinic acid photodynamic therapy|Aminolaevulinic acid mediated photodynamic therapy
16080488|NCT02304744|Other|Observational study, no intervention.|Observational study, no intervention.
16080489|NCT02304731|Other|Physical Exercise|Incremental running
16080490|NCT02304718|Behavioral|Stationary bike|
16080491|NCT02304705|Drug|Sildenafil|20 mg three times daily by mouth for 90 days
16080492|NCT02304705|Drug|Placebo|One capsule three times daily by mouth for 90 days
16080493|NCT02304692|Device|Bone anchored hearing aid|
16080494|NCT02304679|Other|Pre-inclusion questionnaires|"(Month -2)
~During this visit, the investigator will:
~Validate the patient's inclusion and exclusion criteria;
~Obtain informed consent from the patient;
~Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope in order to respect patient confidentiality.
~Prescribe 1 month of PDE5i treatment.
~The next visit will be scheduled"
16080495|NCT02304679|Drug|1 month of PDE5i treatment|5 mg Tadalafil per day for 1 month
16080496|NCT02304679|Other|PDE5i follow-up questionnaires|"(Month -1)
~During this visit the investigator will:
~Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope in order to respect patient confidentiality.
~Perform a clinical exam; particular attention is given to the recording of complications / adverse events.
~Remind the patient that over the next 4 weeks he is not to take any treatments for his condition (wash-out period).
~The next visit will be scheduled"
16080754|NCT02302807|Drug|Docetaxel|Docetaxel 75 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle.
16080497|NCT02304679|Other|Inclusion questionnaires|"(Day 0)
~During this visit the investigator will:
~Verify inclusion and exclusion criteria, and proceed with final inclusion
~Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope in order to respect patient confidentiality.
~Perform a clinical exam; particular attention is given to the recording of complications / adverse events.
~Randomize the patient at the end of the visit
~The patient will go home with a calendar specifying the time and place of the various visits. The patient should have four weekly LIESWT or sham sessions within the next month. The first session may take place the same day and immediately after the present visit."
16080498|NCT02304679|Device|4 weekly LIESWT (Wave 1) with the RENOVA device|Following final inclusion, patients will have weekly LIESWT sessions (one session per week for four weeks). Particular attention is given to the recording of complications/adverse events. At the end of each session, the patient is asked to evaluate the level of pain that occurred during the session using a visual analog scale.
16080499|NCT02304679|Device|4 weekly sham LIESWT (Wave 1) with the RENOVA device|Following final inclusion, patients will have weekly sham LIESWT sessions (one session per week for four weeks). Particular attention is given to the recording of complications/adverse events. At the end of each session, the patient is asked to evaluate the level of pain that occurred during the session using a visual analog scale.
16080500|NCT02304679|Other|Follow-up questionnaires 1 month after Wave 1|"(Month 2)
~During this visit the investigator will:
~Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope.
~Perform a clinical exam; particular attention is given to the recording of complications / adverse events."
16080501|NCT02304679|Other|Follow-up questionnaires 3 months after Wave 1|"(Month 4)
~During this visit the investigator will:
~Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope.
~Perform a clinical exam; particular attention is given to the recording of complications / adverse events.
~The patient should have four weekly LIESWT sessions within the next month. The first session may take place the same day and immediately after the present visit."
16080502|NCT02304679|Device|8 bi-weekly LIESWT (Wave 2) with the RENOVA device|During the 5th month following final inclusion, all patients will have bi-weekly LIESWT sessions. These will occur twice per week for four consecutive weeks. Particular attention is given to the recording of complications/adverse events. At the end of each session, the patient is asked to evaluate the level of pain that occurred during the session using a visual analog scale.
16080503|NCT02304679|Other|Follow-up questionnaires 1 month after Wave 2|"(Month 6)
~During this visit the investigator will:
~Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope.
~Perform a clinical exam; particular attention is given to the recording of complications / adverse events."
16080504|NCT02304679|Other|Questionnaires via postal mail|Eight, 11, and 14 months after final inclusion, corresponding to 3, 6 and 9 months following Wave 2, the IIEF, SEP2, SEP3, GAQ and EHS questionnaires will be sent to patients via postal mail.
16080505|NCT02304679|Other|Final follow-up questionnaires 12 months after Wave 2|"(Month 17)
~During this visit the investigator will:
~Have the patient fill out the IIEF, SEP-2, SEP-3, EHS and GAQ questionnaires. Responses are place and sealed in a specifically provided envelope.
~Perform a clinical exam; particular attention is given to the recording of complications / adverse events."
16080506|NCT02304666|Procedure|Colonoscopy for biopsies samples|
16080507|NCT02304653|Other|Clinical descision making|Chage in diagnosis before and after the presentation of the reults of CRP and Leucocytes
16080508|NCT02304627|Drug|insulin 338 (GIPET I)|Each subject will be randomly allocated to a fixed treatment sequence of four single-dose administrations of oral insulin 338 in a GIPET® I tablet, administered on four separate dosing visits. The subjects will be dosed in the morning in the fasting state prior to four different post-dose fasting periods.
16080509|NCT02304614|Other|3D surface imaging using a non portable and portable camera|The participant will have 3D surface imaging taken of their breasts (the face will not be shown)
16080510|NCT02304614|Other|Patient reported outcome measure (PROM): BREAST-Q|The participant will answer the BREAST-Q questionnaire. This is a patient reported outcome measurement of satisfaction and quality of life after BCT
16080511|NCT02304614|Other|2D photography|The participant will have standard medical photography of their breasts (the face will not be shown)
16080512|NCT02304614|Other|Applanation Tonometry|A small 300g disc is placed on the breast to measure the surface area of contact with the breast to measure compressibility
16080513|NCT02304588|Biological|Mesenchymal stem cells|10-20 x 10^6 cells/20mL
16080514|NCT02304575|Other|Questionnaires|"Questionnaires:
~For examinee: European Organization for Research and Treatment of Cancer quality of life questionnaire of 30 items and testicular cancer module of 26 items (EORTC QLQ-30 + QLQ-TC-26), Multidimensional Coping Inventory, The Meaning Test for cognitive function, cognitive orientation questionnaires.
~For partner: Multidimensional Inventory of quality of life (QoL) for Adults, Multidimensional Coping Inventory."
16080515|NCT02304575|Other|Hormonal Function measurement|Plasma levels of: follicular stimulating hormone (FSH), luteinizing hormone (LH), thyroid-stimulating hormone (TSH), prolactin, free androgen index.
16080516|NCT02304562|Biological|UCB Mesenchymal Stem Cells treatment|reduce skin injury
16080517|NCT02304536|Drug|FSH|70 women will receive urinary purified FSH (Fostimon® IBSA, Switzerland) 75IU daily for 7 days starting from the 3rd day of menstruation or progesterone withdrawal bleeding. If the follicle does not exceed 9mm the dose will be increased by 37.5IU every 7 days. The cycle will be cancelled if no follicles exceed 9mm 4 weeks after starting FSH. This was combined with oral metformin (Cidophage® CID, Egypt) 500 mg three times per day
16080518|NCT02304536|Procedure|Laparoscopic ovarian drilling|70 women will have LOD in which the ovaries will be stabilised by grasping the ovarian ligament and monopolar diathermy will be used to do 4-10 punctures in each ovary. The number of punctures will be individualised according to the size of the ovary. Serial vaginal ultrasound scans were done starting from the 10th day of menstruation, the frequency of monitoring will be individualized according to the women's response.
16080519|NCT02304523|Drug|CDFR0612|Preparation 500mL is a mixture of CDFR0612 150mL and water 350mL. A total of 2L (Preparation 1L and additional water 1L) will be administrated divided into two in evening before and in early morning at that day of colonoscopy.
16081145|NCT02299999|Drug|Methotrexate|DNA intercalators
16080520|NCT02304523|Drug|CDFR0613|Preparation 500mL is a mixture of CDFR0613 150mL and water 350mL. A total of 2L (Preparation 1L and additional water 1L) will be administrated divided into two in evening before and in early morning at that day of colonoscopy.
16080521|NCT02304523|Drug|Coolprep Powder|Preparation 500mL is a water solution of Coolprep Powder A and B. A total of 3L (Preparation 2L and additional water 1L) will be administrated divided into two in evening before and in early morning at that day of colonoscopy.
16080522|NCT02304497|Other|Platelet Rich Fibrin|Procedure: Platelet Rich Fibrin obtained
16080523|NCT02304484|Biological|Evolocumab|Administered by subcutaneous injection once a month
16080524|NCT02304458|Biological|Ipilimumab|Given IV
16080525|NCT02304458|Other|Laboratory Biomarker Analysis|Correlative studies
16080526|NCT02304458|Biological|Nivolumab|Given IV
16080527|NCT02304458|Other|Pharmacological Study|Correlative studies
16080528|NCT02304445|Procedure|Transarterial Chemoembolization (TACE)|TACE is a treatment modality where local delivery of an anti-neoplastic agent is performed through the feeding artery of the tumor followed by end embolization of the artery. The goal of TACE is to cause tumor necrosis and tumor control via acute arterial occlusion while preserving as much functional liver tissue as possible.
16080529|NCT02304445|Radiation|TACE+Stereotactic Body Radiotherapy|This intervention adds Stereotactic Body Radiation (SBRT) to TACE therapy. SBRT is the precise administration of large doses of radiotherapy delivered over 1-5 treatments to extra-cranial tumors.
16080530|NCT02304432|Drug|D-cycloserine|Both participants received open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks.
16080531|NCT02304432|Drug|DCS or placebo|Double-blind placebo-controlled exposures to DCS or placebo x 6 weeks. One participant received exposure to DCS x 6 weeks and then received placebo dosing x 6 weeks. The other participant received exposure to placebo dosing x 6 weeks and then DCS x 6 weeks.
16080532|NCT02304432|Drug|D-cycloserine|Both participants received second open label D-cycloserine (seromycin), 50 mg/d capsule, x 8 weeks.
16080533|NCT02304419|Drug|Galunisertib|Administered orally.
16080534|NCT02304393|Drug|Atezolizumab|Atezolizumab will be administered as per the dosage regimen mentioned in respective arm descriptions.
16080535|NCT02304393|Drug|Selicrelumab|Selicrelumab will be administered as per the dosage regimen mentioned in respective arm descriptions.
16080536|NCT02304367|Biological|Burosumab|Solution for subcutaneous injection
16080537|NCT02304354|Drug|Rituximab|For rheumatoid arthritis, MabThera is given as two intravenous infusions of 1000 mg with a two-week interval between them. Patients usually respond to treatment within 16 to 24 weeks of initial treatment. After 24 weeks, treatment can be repeated depending on the patient's response.
16080538|NCT02304328|Other|Clinical assessment|Patients will be clinically assessed whether they present clinical signs of brain herniation syndromes
16080539|NCT02304315|Biological|GC1102 50,000 IU|a recombinant hepatitis B immunoglobulin
16080540|NCT02304315|Biological|GC1102 80,000 IU|a recombinant hepatitis B immunoglobulin
16080541|NCT02304302|Drug|Memantine|Encapsulated Namenda 10 mg bid (after four week dose escalation protocol)
16080542|NCT02304302|Drug|Placebo|Identically looking placebo capsules bid (after a four-week regimen designed to mimic dose escalation protocol)
16080544|NCT02304276|Radiation|18F-Fluoride PET-CT|Injection of 18F-Fluoride with target activity 125MBq giving an anticipated radiation exposure of 3mSv CT scanning protocol giving an anticipated radiation exposure of 13mSv
16080545|NCT02304276|Radiation|CT calcium score of aortic valve|CT associated with an anticipated radiation exposure of 3mSv (Cohorts 2 and 3 only)
16080546|NCT02304263|Drug|iohexol|5mL bolus of 300 mg/ml iohexol (Omnipaque) over 2 minutes
16080547|NCT02304250|Drug|Dexamethasone|dexamethasone 1ml (5mg)
16080548|NCT02304250|Drug|saline|saline 1ml
16080549|NCT02304237|Drug|Vaginal progesterone|micronized progesterone 200mg/day till 36 weeks 6 days of gestation or premature rupture of membranes
16080550|NCT02304237|Drug|Intramuscular progesterone|hydroxyprogesterone caproate 250mg/ml/week till 36 weeks 6 days of gestation or premature rupture of membranes
16080551|NCT02304224|Other|eye masks|eye masks from 21:00 to 6:00 each night during admission
16080552|NCT02304211|Drug|Insulin|Insulin will be administered either into the radial artery (microdose intervention) or IV (systemic intervention).
16080553|NCT02304198|Drug|Udenafil|Udenafil 50mg tablet
16080554|NCT02304185|Biological|gp140, 50 mcg|Glycoprotein 140 (gp140) vaccine containing 50 microgram (mcg) total protein will be administered intramuscularly on Day 1 and Day 29.
16080555|NCT02304185|Biological|gp140, 50 mcg + Adjuvant|The gp140 vaccine containing 50 mcg total protein mixed with 0.425 milligram (mg) aluminum phosphate adjuvant will be administered intramuscularly on Day 1 and Day 29.
16080556|NCT02304185|Biological|gp140, 250 mcg|The gp140 vaccine containing 250 mcg total protein will be administered intramuscularly on Day 1 and Day 29.
16080557|NCT02304185|Biological|gp140, 250 mcg + Adjuvant|The gp140 vaccine containing 250 mcg total protein mixed with 0.425 mg aluminum phosphate adjuvant will be administered intramuscularly on Day 1 and Day 29.
16080558|NCT02304185|Drug|Placebo|Placebo matched to gp 140 vaccine drug product will be administered intramuscularly on Day 1 and Day 29.
16080559|NCT02304172|Device|Thunderbeat (Group A)|hemostatic device utilized intraoperatively
16080560|NCT02304172|Device|Harmonic (Group B)|hemostatic device utilized intraoperatively
16080561|NCT02304159|Drug|daclatasvir|
16080562|NCT02304159|Drug|Sofosbuvir, Sovaldi|
16080563|NCT02304159|Drug|Ribavirin|
16080564|NCT02304133|Other|Education|
16080565|NCT02304120|Other|Proprioceptive postural training|
16080566|NCT02304120|Other|Treadmill training|
16080567|NCT02304120|Other|Conventional physiotherapy|All participating patients will attend usual care according to their treatment plan (taking part in the study does not affect the treatment plan). A physiotherapy referral requests 9 treatments, each of which takes 30 minutes. These will take place twice a week for 4.5 weeks. The study protocol does not dictate the content of the physiotherapy sessions themselves, but detailed documentation of provided treatments is required (therapy documentation sheet). Additionally, the aim of the physiotherapy sessions should always include reduction of muscular imbalances and optimisation of posture.
16080568|NCT02304107|Drug|FSH|75IU daily for 7 days starting from the 3rd day of menstruation or progesterone withdrawal bleeding. If the follicle does not exceed 9mm the dose will be increased by 37.5IU every 7 days
16080569|NCT02304107|Drug|Letrozole|70 women will receive Letrozole (Femara®, Novartis, Switzerland) 2.5mg twice daily for 5 days starting from the 3rd day of menstruation or progesterone withdrawal bleeding.
16080570|NCT02304094|Drug|methylprednisolone|the steroid group shall receive a single injection of 1 mL methylprednisolone [40 mg] and 1 mL 2% lignocaine
16080571|NCT02304094|Other|Manual manipulation|the manipulation group shall have the lesser MTPJs of the affected foot manually manipulated using a high velocity, low amplitude thrust technique
16080572|NCT02304081|Drug|Saxagliptin|competitive inhibitor of human dipepitdylpeptidase (DPP)-IV
16080573|NCT02304081|Drug|Placebo for Saxagliptin|
16080574|NCT02304068|Other|Home monitoring|
16080575|NCT02304068|Other|Hospital assessment|
16080576|NCT02304055|Drug|Carbetocin|100 women with atonic PPH will receive Carbetocin 100 µgm slowly iv.
16080577|NCT02304055|Drug|Oxytocin|100 women with atonic PPH will receive Oxytocin 5IU slowly iv.
16080578|NCT02304042|Drug|Carbetocin|Carbetocin will be given slowly iv after delivery of the anterior shoulder.
16080579|NCT02304042|Drug|Oxytocin|Oxytocin will be given slowly iv after delivery of the anterior shoulder.
16080580|NCT02304029|Device|MRI|
16080581|NCT02304016|Behavioral|Pelvic floor physical therapy|Patients in this arm will be receiving pelvic floor physical therapy
16080582|NCT02304003|Other|Structured Physiotherapy Regimen|Experimental group will be treated with heavy-slow resistance exercises targeted at the rotator cuff tendons, and exercises to improve scapular stability and strength. Glenohumeral mobilisation techniques and and stretching of glenohumeral capsule and pectoralis minor. Rotator cuff tendons and glenohumeral synovia will be irradiated with low level laser according to WALT dosage recommendations . Intervention period is 12 weeks. Three weekly treatment sessions at 0-3 weeks. 4-12 weeks one treatment session weekly , and two days of home-exercise per week.
16080583|NCT02304003|Other|Standard Care|Standard follow up in primary care.
16080584|NCT02303990|Drug|Pembrolizumab|
16080585|NCT02303990|Radiation|Radiotherapy|
16080586|NCT02303977|Drug|Abraxane|
16080587|NCT02303977|Drug|Gemcitabine|
16080588|NCT02303964|Biological|Plasma|Type A thawed plasma (up to 2 units) will be administered to polytrauma subjects randomized to plasma arm of study
16080589|NCT02303964|Drug|Normal saline|Normal saline will be administered to polytrauma subjects randomized to normal saline arm of study
16080590|NCT02303951|Drug|Vemurafenib|Run-In: Day 1-21 960 mg bid orally, Day 22-28 720 mg bid orally Triple-Treatment (week 5 ongoing): 720 mg bid orally
16080591|NCT02303951|Drug|Cobimetinib|Run-In: Day 1-21 60 mg od orally Triple-Treatment (week 5 ongoing): 60 mg od 21/7 orally (3 weeks on drug, 1 week off)
16080592|NCT02303951|Drug|Atezolizumab|Triple-Treatment (week 5 ongoing): 840 mg Q2W i.v
16080593|NCT02303938|Behavioral|physical exercise|Patients in the intervention group will undergo a 6-month home-based exercise intervention. Patients will exercise (e.g., running, biking, swimming) three times per week for 6 months. Session duration will vary between 20 minutes and 45 minutes.
16080594|NCT02303925|Device|NESTER COILS|
16080595|NCT02303912|Drug|Nuc-1031 and Carboplatin|Nuc-1031 IV injection on day 1 and day 8 repeated every 21 days Carboplatin IV infusion on day 1 repeated every 21 days (Total 6 cycles)
16080596|NCT02303899|Drug|Gemcitabine|infusion drug
16080597|NCT02303899|Drug|Imatinib mesylate|oral drug
16080598|NCT02303886|Drug|Methylene blue|In NaCL0.9% 100 ml
16080599|NCT02303886|Drug|Methylene blue|in NaCl 0.9% 100 ml
16080600|NCT02303873|Drug|Alendronate|Alendronate was administrated as 70 mg/week orally (Fosamax, Merck Sharp & Dohme．LTD.).
16080601|NCT02303860|Drug|ORM-12741 MR A|Modified release formulation of ORM-12741
16080602|NCT02303860|Drug|ORM-12741 MR B|Modified release formulation of ORM-12741
16080603|NCT02303860|Drug|ORM-12741 IR|Immediately release formulation of ORM-12741
16080604|NCT02303847|Drug|Ketamine|ultra-low dose oral ketamine twice daily in two different doses over a 2 week period.
16080605|NCT02303834|Device|Continuous Positive Airway Pressure Ventilation (CPAP)|A mask worn over the nose that delivers air under slight pressure.
16080606|NCT02303821|Drug|Carfilzomib|
16080607|NCT02303821|Drug|Dexamethasone|
16080608|NCT02303821|Drug|Mitoxantrone|
16080609|NCT02303821|Drug|PEG-asparaginase|
16080610|NCT02303821|Drug|Vincristine|
16080611|NCT02303821|Drug|Intrathecal (IT) Methotrexate|
16080612|NCT02303821|Drug|Intrathecal Triple Therapy (Intrathecal Cytarabine, Hydrocortisone, and Methotrexate)|
16080613|NCT02303821|Drug|6-Mercaptopurine|
16080614|NCT02303821|Drug|Cyclophosphamide|
16080615|NCT02303821|Drug|Cytarabine|
16080616|NCT02303821|Drug|Daunorubicin|
16080617|NCT02303808|Device|INHALATION WITH PEP DEVICE (Acapella Duet)|Intervention will be performed during 5 consecutive days. The performance order of both arms will be randomized.
16080618|NCT02303795|Drug|Rivaroxaban|Patients assigned to rivaroxaban will receive oral rivaroxaban, 20 mg od. Patients with a calculated creatinine clearance of 30 to 49 mL/min per 1.73 m2 received a reduced dose of rivaroxaban of 15 mg od.
16080619|NCT02303795|Drug|Warfarin|"Patients will take the warfarin once daily (q.d.). The individual doses will be titrated as needed to maintain a target INR of 2.0-3.0.
~Patients with 65 > years old, should take warfarin (2,5mg/day) and all others patients should take 5mg/day."
16080620|NCT02303782|Drug|OTX015|
16080621|NCT02303782|Drug|Vidaza (azacitidine)|
16080622|NCT02303769|Drug|Tamsulosin HCL 0.4mg|Tamsulosin HCL 0.4mg once a day
16080623|NCT02303769|Drug|Tamsulosin HCL 0.2mg|Tamsulosin HCL 0.2mg once a day
16080624|NCT02303756|Device|Pillcam® COLON Capsule|colonoscopy
16080625|NCT02303743|Device|Smart Phone Application|Bowel preparation was evaluated using the Harefield Cleansing Scale (HCS). The scale was the primary outcome measure
16080626|NCT02303743|Device|Written instructions with visual aids|written instructions with visual aids explaining the procedure and when to begin self-administration of the bowel solution (control group).
16080627|NCT02303730|Drug|Exenatide|The starting dose of exenatide is 5 ug bid, subcutaneously, for 4 weeks, followed by 10 ug bid, subcutaneously, for 20 weeks. If hypoglycaemia (blood glucose<2.9 mmol/l or < 3.9 mmol/l at least 2 times) or serious intolerance occurs, the dose will be adjusted to 5 ug bid, subcutaneously.
16080628|NCT02303730|Drug|insulin glargine|"The starting dose of insulin glargine will depend upon the HbA1c level at screening(HbA1c <8% use 0.1 -0.2 U/kg per day;HbA1c >8% use 0.2 -0.3 U/kg per day).
~Dose adjustment protocol for insulin glargine (at least 3 determinations of fasting blood glucose per week):
~fasting blood glucose(FBG) > 180 mg/dL(10 mmol/l): add 4 U; FBG 140-180 mg/dL(7.8-10 mmol/l): add 2 U; FBG 126-139 mg/dL(7.0-7.8 mmol/l): add 1 U.
~If hypoglycemia, reduce insulin glargine by:
~blood glucose <70mg/dl（3.9mmol/l）: 10%-20%; blood glucose <40mg/dl（2.2mmol/l）: 20%-40%."
16080629|NCT02303717|Device|Percutaneous coronary intervention|Percutaneous coronary stent implantation
16080630|NCT02303717|Drug|Dual antiplatelet therapy|Dual antiplatelet therapy with aspirin and either clopidogrel, prasugrel or ticagrelor will be recommended for 12 months duration in the Xience stent arm but only 4 months duration in the Synergy stent arm.
16080631|NCT02303704|Procedure|multiport antegrade cardioplegia|Cold blood cardioplegia was used for myocardial protection and just before the removal of the aortic cross-clamp, warm blood shot (normo-kalemic) was started through multi-perfusion set attached to cardioplegia cannula in the aortic root and vein grafts.As contraction of heart started the multiport limb attached to cardioplegia cannula was off and cross clamp was removed .The warm perfusion through the vein grafts was continued at controlled pressures of about 50-70 mmHg, flow rate of 10-30ml/min/graft and temperature of 35-37 oC
16080632|NCT02303704|Procedure|Aortic root antegrade cardioplegia|only cold blood cardioplegia was used for myocardial protection without hotshot.
16080633|NCT02303691|Behavioral|Attention Bias Modification|Excessive attention to threat is theorized to be a critical contributor to chronic anxiety symptoms and related negative health consequences. Attention Bias Modification, which directly targets this mechanism, is a highly cost-effective intervention with growing empirical support for its potential efficacy in clinically anxious populations.
16080634|NCT02303691|Behavioral|Neutral Training|A control version of computerized attention training.
16080635|NCT02303678|Drug|D2C7-IT|D2C7-IT is a single-chain fragment variable (scFv) monoclonal antibody (Mab) fragment immunotoxin with high binding affinity for both EGFRwt- and EGFRvIII-expressing glioblastoma multiforme (GBM) cells.
16080636|NCT02303665|Other|The dual therapy|TCM prescriptionⅡof cultivated emotion and assisted reproduction +auricular acupoint therapy
16080637|NCT02303665|Other|The triple therapy|TCM prescriptionⅡof cultivated emotion and assisted reproduction + auricular acupoint therapy+ retention enema of TCM
16080638|NCT02303652|Procedure|Radiofrequency maze procedure|RF energy was used to create continous endocardial and epicardial lesions mimicking most of the left atrial incisions set as described in the Cox Maze III procedure. In all patients a bipolar device was used (Cardioblate BP2 Irrigated RF Surgical Ablation System®, Medtronic Inc, Minneapolis, MN, USA).
16080639|NCT02303652|Procedure|Transthoracic echocardiography|Contemporary to clinical follow up, all patients were evaluated with 2-dimensional transthoracic echocardiography (Philips ultrasound system (iE33®, Andover, MA, USA)) at 3,6,12,24 months in order to specifically monitor the evolution of cardiac chambers dimensions and systolic performance and to record left and right atrial contractility presence.
16080640|NCT02303639|Procedure|Radiofrequency catheter ablation|Catheter ablation with an open-irrigated tip ablation catheter and 3D electroanatomical mapping
16080641|NCT02303639|Drug|Antiarrhythmic drug therapy|Amiodarone (or sotalol) for prevention of VT/VF relapses
16080642|NCT02303626|Drug|BCX4161|
16080643|NCT02303626|Drug|Placebo|
16080644|NCT02303613|Other|Mapping|Mapping of current triage situation regarding 30 days mortality
16080645|NCT02303600|Drug|Montelukast|Patients in biomarker guided positive treatment arm were given Montelukast Sodium Tablets (p.o., 10mg, q.d.). Patients in biomarker guided negative treatment arm were given placebo tablets . Patients in standard treatment arm were given Montelukast Sodium Tablets (p.o., 10mg, q.d.) . All treatment regimens lasted for 10 days and no other antitussive/decongestant or bronchodilators are given to any patients.
16080646|NCT02303600|Other|Placebo|Patients in biomarker guided negative treatment arm were given placebo tablets (main excipient lactose monohydrate) (p.o., 10mg, q.d.) .
16080647|NCT02303587|Drug|methylprednisolone|
16080648|NCT02303574|Drug|AZD7986, oral solution, 1 to 50 mg/mL|Starting dose in single ascending dose part: 5 mg
16080649|NCT02303574|Drug|Placebo, oral solution|Matching placebo
16080650|NCT02303561|Behavioral|CHAMP|Families assigned to this arm will receive tailored asthma education and behavioral skills focused on improving asthma and weight management.
16080651|NCT02303561|Behavioral|Health education|Families assigned to this arm will receive tailored asthma education and general health education on a variety of topics.
16080652|NCT02303548|Drug|Sodium bicarbonate|Administer Sodium bicarbonate 50 mEq IV over 2 minutes
16080653|NCT02303548|Drug|Normal saline|Placebo
16080654|NCT02303535|Procedure|Cardiac Surgery|All patients with congential and acquired heart disease treated by cardiac surgery procedures.
16080655|NCT02303535|Procedure|Therapeutic cardiac catheterisations procedures|All patients with congential and acquired heart disease treated by therapeutic cardiac catheterisations procedures .
16080656|NCT02303522|Other|Other: not applicable - observational study|No intervention exists as this is a retrospective observational study
16080657|NCT02303509|Drug|UCB5857 Part 1|"Active substance: UCB5857
~Pharmaceutical form: Capsule
~Concentration: 1 mg, 5 mg, 10 mg or 15 mg
~Route of administration: Oral"
16080658|NCT02303509|Drug|UCB5857 Part 2|"Active substance: UCB5857
~Pharmaceutical form: Capsule
~Concentration: 5 mg, 8 mg, 15 mg
~Route of administration: Oral"
16080659|NCT02303509|Other|Placebo|"Active substance: Placebo
~Pharmaceutical form: Capsule
~Concentration: Avicel PH 102, 50 mg
~Route of administration: Oral"
16080660|NCT02303496|Biological|Platelet Rich Plasma Cream|Cream Containing Platelet Rich Plasma and Oleaginous Base
16080661|NCT02303496|Biological|Placebo - Sterile Water Cream|Cream Containing Sterile Water and Oleaginous Base
16080662|NCT02303483|Dietary Supplement|Nicotinamide riboside (NIAGEN TM, ChromaDex, CA, USA )|
16080663|NCT02303483|Dietary Supplement|Placebo|
16080982|NCT02301130|Biological|mogamulizumab|Mogamulizumab will be administered intravenously (IV).
16080664|NCT02303470|Behavioral|Vigorous Exercise|High-intensity interval training alternates 30 seconds of vigorous exercise with 30 seconds of low-intensity recovery for a total of 15 minutes.
16080665|NCT02303470|Behavioral|Moderate Exercise|
16080666|NCT02303457|Procedure|CO2 Laser surgery|Patients were randomly assigned to CO2 laser surgery group and open Surgery group.
16080667|NCT02303457|Procedure|Open Surgery|Patients were randomly assigned to CO2 laser surgery group and open Surgery group.
16080668|NCT02303444|Drug|Sorafenib (Nexavar, BAY43-9006)|Patients can get sorafenib at any time during study.
16080669|NCT02303444|Drug|Other Multikinase inhibitors|Patients can get MKIs at any time during study.
16080670|NCT02303431|Drug|Edoxaban low dose|Edoxaban low dose
16080671|NCT02303431|Drug|Edoxaban high dose|Edoxaban high dose
16080672|NCT02303418|Drug|Carbetocin|Carbetocin will be given slowly iv after delivery of the baby
16080673|NCT02303418|Drug|Oxytocin|Oxytocin will be given slowly iv after delivery of the baby
16080674|NCT02303405|Drug|Hydroxychloroquine|Anti-inflammatory and anti-malarial agent
16080675|NCT02303405|Drug|Pioglitazone|Anti-hyperglycemic agent
16080676|NCT02303392|Drug|Selinexor|Given PO
16080677|NCT02303392|Drug|Ibrutinib|Given PO
16080678|NCT02303392|Other|Pharmacological Study|Correlative studies
16080679|NCT02303392|Other|Laboratory Biomarker Analysis|Correlative studies
16080680|NCT02303379|Other|Continuous Endurance Training|Endurance training with constant work load 31min at 65-75% Hrmax
16080681|NCT02303379|Other|Pyramid Training|One pyramid consists of 8 one-minute blocks. Those are grouped starting with one block of 70-75% HRmax, followed by one block at 75-80% HRmax and another one at 80-85% HRmax. The top of the pyramid are 2 blocks of 85-90% HRmax. Intensity is lowered afterwards with one block of 80-85% HRmax, followed by one block at 75-80% HRmax and last one at 70-75% HRmax. Two more pyramids follow, each divided by 2min of active recovery at 65-70% HRmax, making it a total of 28min.
16080682|NCT02303379|Other|High-intensity interval training|HIT: 4x4 min intervals at85-95% HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25min.
16080683|NCT02303366|Radiation|Stereotactic Ablative Body Radiosurgery (SABR)|Stereotactic Ablative Body Radiosurgery (SABR) - a single 20Gy in 1 fraction.
16080684|NCT02303366|Drug|MK-3475|MK-3475 (200mg IV) on day 1 every 3 weeks for a total of 8 cycles.
16080685|NCT02303340|Radiation|Dual Energy X-ray Absorptiometry|
16080686|NCT02303327|Radiation|EBRT + HDR brachytherapy boost|Standard radiotherapy (EBRT, 23 fractions) with the addition of High Dose-Rate (HDR) brachytherapy boost within 3 weeks of beginning or finishing the EBRT.
16080687|NCT02303327|Radiation|Hypofractionated Dose Escalation Radiotherapy|Radiation therapy (higher radiation dose per treatment) will be given once a day, five days a week, over approximately 5 weeks.
16080688|NCT02303327|Drug|Androgen deprivation therapy|28 months of androgen deprivation therapy (injections every 4 months for a total of 28 months)
16080689|NCT02303314|Drug|Trigonella Foenum-graecum Seed Extract|
16080690|NCT02303314|Drug|Drug: Placebo|
16080691|NCT02303301|Dietary Supplement|Probiotics|Cultures from the oropharynx
16080692|NCT02303301|Dietary Supplement|Placebo|Cultures from the oropharynx
16080693|NCT02303288|Device|Argus II Retinal Prosthesis System|The Argus II System is designed to provide visual function to individuals with severe to profound vision loss due to outer retinal degeneration. It consists of implanted and external components. The implant is an epiretinal prosthesis that is surgically implanted in and around the eye. The external equipment includes glasses and a video processing unit (VPU). The glasses include a miniature video camera, which captures video images, and a coil that sends data and stimulation commands to the implant. The VPU converts the video images into stimulation commands and is body-worn. The Argus II System operates by converting video images into electrical energy that activates retinal cells, delivering the signal through the optic nerve to the brain where it is perceived as light.
16080694|NCT02303275|Behavioral|Lifestyle Change|"Intervention: Lifestyles Change Program (LCP)
~The LCP is a 12-week multi-disciplinary program that incorporates a holistic approach to chronic disease management, which will be tailored to our study population, patients with chronic heart failure. The core of the LCP includes:
~Clinician, Dietician, Exercise physiologist, Counselor, Nurse Case Manager Medical oversight by board-certified Cardiologist, Exercise prescription, Stress management classes (yoga, meditation, guided imagery), Group support, lifestyle change lectures, body composition analyses, grocery store tour, cooking classes, Music Wellness, and resiliency classes."
16080695|NCT02303275|Behavioral|Lifestyle Change|The lifestyle change program consists of classes conducted three times a week for 12 weeks at the Scripps Center for Integrative Medicine. Each day participants will spend about four to five hours in a variety of classes such as monitored exercise, group support, mindful-yoga and meditation, vegetarian cooking classes, music-centered wellness, mind-body lectures, and resiliency training.
16080696|NCT02303262|Drug|Mocetinostat|Mocetinostat is taken orally at 70 mg/dose, 3 days per week, during cycle 1. Dose is increased to 90 mg starting at cycle 2.
16080697|NCT02303262|Drug|Gemcitabine|Gemcitabine is administered via intravenous infusion at 1,000 mg/m2 at a rate of approximately 10 mg/m2/minute, on days 5 and 12 of every cycle.
16080698|NCT02303249|Other|Review of discharges and cross-sectoral video conferencing immediately after discharge|The intervention is video conference which is randomized and is an intervention that is assigned by the investigator.
16080699|NCT02303223|Drug|Propofol|
16080700|NCT02303210|Device|hearing aid NaidaUP|Standard Power Hearing instruments including different frequency lowering techniques
16080701|NCT02303210|Device|hearing aid NaidaSP|Standard Power Hearing instruments including different frequency lowering techniques
16080702|NCT02303197|Drug|ChiNing decoction|ChiNing decotion was reformed by Liangge San that was stemed from Prescriptions of the Bureau of Taiping People.
16080703|NCT02303184|Drug|4 mg CLS-TA|40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
16080704|NCT02303184|Drug|Sham|suprachoroidal sham procedure
16080705|NCT02303184|Drug|IVT aflibercept|2 mg intravitreal injection of aflibercept
16080706|NCT02303171|Drug|Enoxaparin|Women will be given Enoxaparin throughout pregnancy in a dose of 40 mg/day subcutaneously (SC)
16080755|NCT02302807|Drug|Paclitaxel|Paclitaxel 175 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle.
16080707|NCT02303171|Drug|Warfarin|Women will be given Enoxaparin (40 mg/day SC) in the first trimester then Warfarin (3-5 mg/day) after the first trimester until termination of pregnancy
16080708|NCT02303132|Other|Ussing experiment|fresh colon mucosa (biopsy) of all participants will be mounted in an Ussing chamber and exposed to NSAIDs / PPI / control.
16080709|NCT02303119|Drug|Rituximab IV|intra-venous, 375 mg/m²
16080710|NCT02303119|Drug|Rituximab SC|sub-cutaneous, 1400 mg
16080711|NCT02303106|Drug|Lamotrigine|
16080712|NCT02303093|Biological|Octagam IVIG 5% or 10%|Octagam IVIG 5% or 10%
16080713|NCT02303093|Biological|Panzyga|Panzyga
16080714|NCT02303080|Other|Control (WPM 0)|85.0 % maltodextrin,15.0% fat, 0% WPM
16080715|NCT02303080|Other|WPM 30|43.7% maltodextrin, 15.2% fat, 41.1% (30 g) WPM
16080716|NCT02303080|Other|WPM 50|16.3% maltodextrin, 15.2% fat, 68.5% (50 g) WPM
16080717|NCT02303080|Other|MC 50|16.7% maltodextrin, 15.0% fat, 68.2% (50 g) MC
16080718|NCT02303054|Procedure|Bipolar Radiofrequency Focal Ablation|Men identified as having suspicious regions on a pre-biopsy mpMRI will be considered for enrollment. Following an MRI-US targeted biopsy of the prostate, men testing positive will be eligible for enrollment. All men enrolled in the study will undergo focal radiofrequency ablation and evaluated in follow-up.
16080719|NCT02303041|Drug|Buparlisib|Administered orally at starting dose of 80 mg/day
16080720|NCT02303041|Drug|Sonidegib|Administered orally at starting dose of 200 mg/day
16080721|NCT02303028|Drug|Topotecan and Pazopanib|Low-dose metronomic Topotecan and Pazopanib will be escalated as per the dose escalation schema.
16080722|NCT02303002|Biological|Botulinum Toxin Type A|Intramuscular injection (IM)
16080723|NCT02303002|Biological|Active Comparator botulinum toxin|IM injection
16080724|NCT02303002|Biological|Placebo Comparator|IM injection
16080725|NCT02302989|Drug|Ranibizumab 0.5mg|
16080726|NCT02302976|Drug|cocaine hydrochloride|
16080727|NCT02302976|Drug|exenatide|
16080728|NCT02302976|Drug|placebo|
16080729|NCT02302963|Device|AP System (DiAs or inControl) with USS Virginia|Subject will participate in two 24-hour study insulin pump and AP System training sessions. At the conclusion of each training session, subject will wear the equipment at home for a total of 5 weeks.
16080730|NCT02302963|Device|Sensor-Augmented Pump Therapy (placebo)|Subject will participate in 5 weeks use of CGM and personal insulin pump at home.
16080731|NCT02302950|Drug|raltegravir|HIV therapy component
16080732|NCT02302937|Procedure|Group A will undergo laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm )|laparoscopic TEP inguinal hernia repair with 3 ports (10 mm , and 2 ports of 5 mm ).
16080733|NCT02302937|Procedure|Group B will undergo laparoscopic TEP inguinal hernia repair with a single port|Group B will undergo laparoscopic TEP inguinal hernia repair with a single port LESS (12 to 15 mm transumbilical).
16080734|NCT02302911|Behavioral|Early intensive behavioral intervention|at least 10 hours a week of early intensive behavioral intervention
16080735|NCT02302911|Behavioral|Early intensive eclectic intervention|at least 10 hours a week of early intensive eclectic intervention
16080736|NCT02302911|Other|Treatment as usual|receipt of any Intervention that is less intensive than 10 hours a week
16080737|NCT02302898|Behavioral|Eating Behavior Evaluation|Scores will be measured on binge eating behaviors and an increased craving for sweets.
16080738|NCT02302898|Other|Measurement of Functional gastric volume|The functional gastric volume is the amount of food or liquid that can be consumed to a feeling of comfortably full in one meal.
16080739|NCT02302898|Other|Measurement of gastric pouch and GJ size|Anatomical dimensions of the gastric pouch and GJ will be determined by using an articulated measuring tool during upper GI tract endoscopy.
16080740|NCT02302885|Other|Blood collection|Blood Collection
16080741|NCT02302872|Device|ARTO System|
16080742|NCT02302859|Drug|Nicotine Patch|Participants receive an 8 week supply of Nicotine patches.
16080743|NCT02302859|Behavioral|Questionnaires|Questionnaire completion at baseline on laptop, then weekly for 8 weeks on smartphone, then 3 months after smartphone intervention.
16080744|NCT02302859|Other|Pamphlet|Pamphlet given to participant describing health and financial reasons to quit smoking.
16080745|NCT02302859|Behavioral|Phone Counseling Sessions|"Standard Treatment (ST) Group: Participants receive 8 phone counseling sessions (one session per week) for support in quitting smoking. The calls should last about 15 minutes.
~Automated Treatment (AT) Group: Participants receive brief video clips with advice on how to quit smoking over smartphone, as well as interactive text and picture messages once a week for 8 weeks. The video clips will be about 5 minutes long.
~Participants also have access to additional counseling content on the smart phone, which can be used at any time."
16080746|NCT02302859|Other|Saliva Test|Participants complete saliva cotinine test 3 months after intervention.
16080747|NCT02302859|Device|Smart phone|"Standard Treatment (ST) Group: Participants receive proactive phone counseling (8 sessions) over the 8-week period for support in quitting smoking. The call will last about 15 minutes.
~Automated Treatment (AT) Group: Participants receive brief advice to quit smoking (tailored video clips) and an 8-week automated intervention (interactive text messages and graphical messages) for support in quitting smoking via smartphone."
16080748|NCT02302846|Drug|Ixazomib|4 mg by mouth on Days 1, 8 and 15 of each 28-day cycle.
16080749|NCT02302833|Drug|Cabozantinib S-malate|Given PO
16080750|NCT02302833|Other|Laboratory Biomarker Analysis|Correlative studies
16080751|NCT02302833|Other|Questionnaire Administration|Ancillary studies
16080752|NCT02302820|Other|Advance Care Planning Intervention|"ACP Intervention The ACP intervention involves structured discussions between patients and NCCs using 1 of 4 decision aids in order to clarify patient's values, goals and preferences for living well and sharing goals with family, SDM/HCA, and the health care team. Because the time needed for reflective thinking, decision making and discussions with family are important components of the ACP process, the intervention is designed to occur in at least 3 NCC/patient visits over approximately 4 weeks. The NCC will assist patients in the ACP process following scripts specific to each of the decision aids."
16080753|NCT02302807|Drug|Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody|Atezolizumab will be administered intravenously at a fixed dose of 1200 mg on Day 1 of each 21-day cycle.
16080756|NCT02302807|Drug|Vinflunine|Vinflunine 320 mg/m^2 will be administered intravenously on Day 1 of each 21-day cycle.
16080757|NCT02302794|Procedure|open surgery|Patients in this arm undergo radical resection of gastric cancer in open surgery.Open surgery is a conventional technique for gastric cancer patients.
16080758|NCT02302794|Procedure|laparoscopic surgery|Patients in this arm undergo radical resection of gastric cancer in laparoscopic surgery.Laparoscopic surgery is a new and minimum invasive technique for gastric cancer patients.
16080759|NCT02302781|Other|Questionnaires|Several validated questionnaires, depending on moment in fertility work up or treatment.
16080760|NCT02302768|Dietary Supplement|Selenomethionine|
16080761|NCT02302768|Other|Placebo|
16080762|NCT02302755|Drug|TP10|All patients will be enrolled through the University of Iowa. This study will follow a patient-specific dose-escalation scheme during the Induction Period and subsequent TP10 dose adjustments based on complement levels during the Maintenance Period.
16080763|NCT02302729|Dietary Supplement|Micronutrients|Nutrient Quantity Nutrient Quantity Zinc 9 mg Copper 0.3 mg Iron 12.5 mg Vitamin D3 5 mg Folic Acid 160 mcg Vitamin E 5 mg Iodine 90 mcg Calcium 200 mg Vitamin A 250 mg Phosphorus 150 mg Vitamin C 40 mg Magnesium 40 mg Vitamin B12 0.9 mcg Selenium 17 mcg Thiamine 0.5 mg Manganese 0.17 mg Niacin 0.5 mg Biotin 8 mg Riboflavin 6 mg Vitamin B5 1.8 mg Vitamin B6 0.5 mg
16080764|NCT02302729|Behavioral|Responsive feeding|"Strategy
~Mother ensures that feeding area is set up with infant and mother able to see one another.
~Mother mirrors the infant's facial expressions to attract the infant's attention.
~Mother interprets infant's behavior with a positive voice, Oh, you like the spinach. Mother extends infant's behavior by saying, Oh the cereal is all gone and doing a consistent hand signal Mother models eating, makes positive comments in a nurturing tone. Mother offers finger food or use of utensil"
16080765|NCT02302729|Dietary Supplement|Placebo|Riboflavin Vitamin B2
16080766|NCT02302716|Drug|LY2963016|Administered SC
16080767|NCT02302716|Drug|LANTUS®|Administered SC
16080768|NCT02302716|Drug|Oral Antihyperglycemic Medication|Administered as per standard-of-care.
16080769|NCT02302703|Other|low FODMAP diet vs Gluten free diet|
16080770|NCT02302690|Biological|Blood sample for immunology|
16080771|NCT02302664|Procedure|PRP Injection into Achilles tendon rupture gap|PRP injection delivered into the tendon rupture gap Intervention - PRP Injection: The injection is the intervention. A blood sample is withdrawn from patient. Away from patient part of sample is spun down in centrifuge to produce 'Platelet Rich Plasma' (PRP). Patient returns to treatment area and their own PRP is then injected into tendon rupture gap. This is carried out by a surgeon or extended scope physiotherapist, generally in the outpatient clinic, after a local anaesthetic has been applied. Patient is lying face down during procedure, unaware of treatment given to tendon at back of leg. Remaining blood sample sent for analysis.
16080772|NCT02302664|Procedure|Imitation Injection into Achilles tendon rupture gap|Imitation injection delivered into the tendon rupture gap Sham - Imitation Injection: The injection is the intervention. A blood sample is withdrawn from patient. Treatment is prepared. Patient returns to treatment area and a needle (no syringe) is inserted and held into tendon rupture gap to mimic injection (after local anaesthetic has been applied). No active ingredient given. Carried out by surgeon or extended scope physiotherapist, generally in the outpatient clinic. Patient is lying face down during procedure, unaware of treatment given to tendon at back of leg. Blood sample sent for analysis.
16080773|NCT02302651|Device|MR guided High Intensity focused ultrasound|High Intensity Focused Ultrasound is a totally non-invasive procedure that can destroy tumors transcutaneously; safety and efficacy profile are dramatically increased by the MRI guidance
16080774|NCT02302638|Other|embryo culture in different single-step media|Half of each patient's oocytes will be randomly allocated to be cultured either in Sage 1-step medium (Origio) or in CSC medium (Irvine Scientific) for up to six days following oocyte retrieval.
16080775|NCT02302625|Behavioral|Cognitive behavior therapy|Cognitive behavior therapy based on exposure and response prevention. The treatment also incorporates mindfulness training as a means to increasing tolerance for aversive thoughts and emotions associated with AD. The treatment is delivered by a licensed psychologist and comprises 10 individual weekly sessions.
16080776|NCT02302612|Behavioral|CREATE Wellness|Patients allocated to the intervention arm will receive three group sessions with between visit contacts designed to increase activation and engagement with their care plans. They will also continue to be enrolled in the KP PHASE program
16080777|NCT02302612|Other|Usual Care Control|Patients allocated to the control arm will continue to receive usual care, including disease management within the KP PHASE program.
16080778|NCT02302599|Biological|Umbilical cord mesenchymal stem cells|Infusion treatment
16080779|NCT02302599|Biological|Controlled suspension liquid|Infusion treatment
16080780|NCT02302586|Drug|Thoracic paravertebral block (TPVB)|Thoracic paravertebral block (TPVB) is being performed by injecting 5 mL of Bupivacaine 0.5% to 4 consecutive level of paravertebral spaces between T4 and T8 by using landmark technique
16080781|NCT02302586|Drug|Patient Controlled Analgesia (IV PCA)|IV morphine patient controlled analgesia (PCA) is being used in the postoperative period for 48 hours. Basal infusion: 0.3 mg/kg/h, Bolus: 1 mg, Lock-out time: 20 min, 4-h limit: 10-12,5 mg
16080782|NCT02302573|Drug|contast-enhanced ultrasound with sonovue|contast-enhanced ultrasound with sonovue
16080783|NCT02302547|Drug|triple therapy|Dosage treatment and usual prescription
16080784|NCT02302547|Drug|dual therapy|1 tablet (200mg/245mg) daily for 48 weeks
16080785|NCT02302534|Device|MRI|MRI
16080786|NCT02302521|Device|Multiplex Sensitivity Encoding (MUSE)|It is an algorithm for MRI post-processing/image reconstruction (see reference: Chen).
16080787|NCT02302508|Drug|Clopidogrel, Prasugrel, Ticagrelor|PK and PD parameters will be compared between groups and comparison will be performed between antiplatelet agents
16080788|NCT02302495|Drug|Carfilzomib|"DOSING REGIMEN.
~The regimen will have 2 parts:
~Part 1. Induction. Nine 5 weeks cycles (35-days each) of weekly Carfilzomib Melphalan Prednisone are planned Carfilzomib. 36, 45, 56 or 70 mg/m² on days 1, 8, 15, 22 IV route followed by a 13-day rest period per 35-days cycle. Patients will start the first cycle day 1 with 20mg/m².
~In combination with oral Melphalan 0.25mg/kg/j and oral prednisone 60mg/m², both on days 1 to 4.
~Part 2. Maintenance. Carfilzomib. 36 mg/m² weekly, every two weeks IV route for 1 year. Melphalan and Prednisone is not pursued at this phase of the study."
16080789|NCT02302482|Other|The Lawton Instrumental Activities of Daily Living score (IADL), and the disability assessment of dementia score (DAD-6|
16080790|NCT02302469|Drug|Revlimid|Three cohorts of subjects will be successively exposed to escalating doses of Lenalidomide (15, 20 and 25mg once daily on days 1-21 of a 28 day cycle).
16080791|NCT02302456|Drug|Tranexamic Acid|Intravenous administration of a 10 mL solution containing 1g of tranexamic acid within 2 minutes of birth and routine prophylactic IV injection of oxytocin
16080792|NCT02302456|Drug|Placebo|Intravenous administration of 10 mL of 0.9% sodium chloride solution within 2 minutes of birth and routine prophylactic IV injection of oxytocin
16080793|NCT02302443|Biological|HM12470|Single dose subcutaneous administration ranging from a very low dose to high dose
16080794|NCT02302443|Biological|Active comparator|Single dose subcutaneous administration of active comparator
16080795|NCT02302430|Drug|Oxytocin|20 International Units Intranasal Oxytocin
16080796|NCT02302430|Other|Placebo comparator|Saline nasal spray
16080797|NCT02302417|Procedure|Spirometry|Classification of respiratory diseases by Spirometry will be performed to differentiate subjects between Asthma only, ACOS, and COPD only. Spirometry obtained from measurements in the past 6 months is acceptable for purposes of this study. For subjects without spirometry in the past 6 months, spirometry will be performed to obtain pre- and post-bronchodilator Forced Expiratory Volume in one second (FEV1), Forced Vital Capacity (FVC) and reversibility
16080798|NCT02302417|Other|ACOS clinical questionnaire|The 41-question questionnaire includes questions concerning the following: a) response to bronchodilator, b) disease progression, c) variations in symptom, d) atopic history, e) symptom triggers, f) vagal bias, g) burden of disease, h) symptom presentation, i) emotional aspects, and j) age of onset. In addition, two questions will capture patient perception of his/her respiratory disease and the physician's diagnosis
16080799|NCT02302404|Drug|GSK2982772 solution|Clear, colorless solution containing GSK2982772 in water with 5% ethanol (0.1mg/mL). Administered orally in required volumes for dosing less than 5mg
16080800|NCT02302404|Drug|GSK2982772 capsule|Size 00 White Opaque capsule containing GSK2982772 as white to almost white solid. Administered orally with water for dosing from 5 to 120 mg
16080801|NCT02302404|Drug|Placebo solution|Clear, colorless solution containing placebo in water with 5% ethanol (0.1mg/mL). Administered orally in required volumes for dosing less than 5mg
16080802|NCT02302404|Drug|Placebo capsule|Size 00 White Opaque capsule containing Placebo as white to almost white solid
16080803|NCT02302391|Other|PK analysis|Quantification of Serum Levels and subsequent pharmacokinetic (PK) modelling.
16080804|NCT02302378|Procedure|Lumbar paramedian approach at L3-L4 interspace|Spinal anesthesia will be performed via a lumbar paramedian approach at L3-L4 interspace using 12.5mg 0.5% Bupivacaine (preservative free)
16080805|NCT02302378|Procedure|Taylor's approach (paramedian approach at L5-S1 interspace)|Spinal anesthesia will be performed via Taylor's approach (paramedian approach at L5-61 interspace) using 12.5mg 0.5% Bupivacaine (preservative free)
16080806|NCT02302365|Device|Spectra Optia® Apheresis System|White Blood Cell Depletion
16080807|NCT02302352|Other|Probiotic|Probiotic 1g once a day by mouth for 8 weeks
16080808|NCT02302352|Other|Placebo|Maltodextrin 1g, manufactured to mimic the probiotic, once a day by mounth for 8 weeks
16080809|NCT02302339|Drug|glembatumumab vedotin|
16080810|NCT02302339|Drug|glembatumumab vedotin and varlilumab|
16080811|NCT02302339|Drug|glembatumumab vedotin and PD-1 targeted checkpoint inhibitor (nivolumab OR pembrolizumab)|
16080812|NCT02302339|Drug|glembatumumab vedotin and CDX-301|
16080813|NCT02302326|Drug|Metformin|Dose: metformin (1700 mg / day) for 12 weeks
16080814|NCT02302326|Dietary Supplement|Myo-inositol + folic acid|Dose: Ovusitol® (4 g myo-inositol plus 400 micrograms of folic acid/day) for 12 weeks
16080815|NCT02302313|Device|CO2 laser and ANI monitor|Painful skin stimuli of variable intensity will be delivered by a CO2 laser used at the power of 0.3 W for each stimulation (6/phases) and this for each of the 3 phases (critical consciousness or hypnosis). During each stimulation, ANI values will be identified by the Physiodoloris ® monitor, through 3 standard ECG electrodes placed on the thorax of the subject.
16080816|NCT02302300|Device|Manufacturer STELLAR 150|5 days of non-invasive ventilation at two levels of pressure from it pre-operative, followed by 5 days in post-operative.
16080817|NCT02302287|Dietary Supplement|Ketoacids diet|Ketoacids diet for 6 months: protein 0,3-0,5 g/bw/day (animal protein 0 g/day, plant protein 30-40 g/day); energy 30-35 kcal/bw/day; Calcium 1,1-1,3 g, phosphate 0,6-0,8 g/day; sodium 6 g/day, potassium 2-4 g/day; mixture of essential aminoacids and ketoacids 0,05 g/kg ideal bw/day
16080818|NCT02302287|Other|Mediterranean diet|Mediterranean diet for 6 months: protein 0,7-0,8 g/bw/day (animal protein 30-40 g/day, plant protein 40-50 g/day); energy 30-35 kcal/bw/day; Calcium 1,1-1,3 g, phosphate 1,2-1,5 g/day; sodium 2,5-3 g/day, potassium 2-4 g/day
16080819|NCT02302287|Other|Free diet|Free diet for 3 months: protein 1 g/body weight/day (animal protein 50-70 g/day, plant protein 15-20 g/day); energy 30-35 kcal/bw/day; Calcium 1,1-1,3 g, phosphate 1,2-1,5 g/day; sodium 6 g/day, potassium 2-4 g/day;
16080820|NCT02302274|Drug|flecainide iv|infusion over 10 min
16080821|NCT02302248|Behavioral|Crowdsourcing reappraisal intervention|3 week access to a web-based crowdsourcing reappraisal platform.
16080822|NCT02302248|Behavioral|Expressive writing intervention|3 week access to a web-based expressive writing platform.
16080823|NCT02302235|Other|Ketogenic Diet|Treatment will consist of ketogenic diet. KD will consist of 4:1 [fat] : [protein+carbohydrate] weight ratio with 1600 kcal restriction.
16080824|NCT02302235|Other|Standardized Diet|Participants with GBM treated with radiation and temozolomide after surgical debulking treatment. The subjects will be taken standard diet in a 1:1 ratio. Diet will be started at the time of initiation of radiation treatment.
16080825|NCT02302222|Device|Customizable Dressing with ActiV.A.C. Therapy Unit|
16080826|NCT02302222|Device|Standard of Care Dressing|
16080827|NCT02302209|Drug|Oxytocin|
16080828|NCT02302209|Other|Placebo Comparator|
16080867|NCT02301910|Drug|Recombinant staphylokinase|15 mg of drug reconstituted in 15 ml of 0.9% solution of NaCl given as single i.v. bolus over 5 - 10 seconds
16080974|NCT02301169|Drug|Administration of placebo capsules|This treatment is given as add on therapy to patients' regular analgesic
16080829|NCT02302196|Procedure|Autologous Fat Grafting of the Breast|In fat grafting, fat tissue is removed from other parts of the body; usually thighs, belly, and buttocks by liposuction. The tissue is then processed and injected into the breast area to reconstruct or recreate the breast. The fat will be removed from by a narrow surgical instrument (cannula) through a small incision. Then the fat will be prepared in a specific way before being replaced back in the body. This preparation may include washing, filtering, and centrifugation (spinning) of the fat. The fat is then placed into the desired area of the breast using either a smaller cannula or needle.
16080830|NCT02302196|Other|Control Arm|Retrospective chart review for women who have undergone standard breast reconstruction for lumpectomy.
16080831|NCT02302183|Device|FreeO2 v2.0 automatic adjustment|
16080832|NCT02302183|Device|FreeO2 v2.0 data collecting|
16080833|NCT02302170|Biological|H. pylori vaccine|
16080834|NCT02302170|Biological|placebo|
16080835|NCT02302157|Biological|AST-OPC1|One injection of 2 million or 10 million AST-OPC1 cells, or 2 injections of 10 million AST-OPC1 cells for a total of 20 million cells; cohort dependent
16080836|NCT02302144|Behavioral|Balance & Strengthening Exercises|Progressive balance and strengthening exercises conducted in a group format yet tailored to each individual
16080837|NCT02302131|Other|SAPIEN XT|Patients that have undergone percutaneous implantation of an Edwards SAPIEN XT Transcatheter Heart Valve in the pulmonic position at the time of data collection
16080838|NCT02302118|Procedure|Esophagogastrectomy|Esophagogastrectomy
16080839|NCT02302105|Radiation|IGRT|Image Guided RT to the prostate
16080840|NCT02302092|Drug|Flomoxef|Flomoxef intravenous infusion
16080841|NCT02302092|Drug|Cefepime|Cefepime intravenous infusion
16080842|NCT02302079|Drug|ASP8232|oral capsule
16080843|NCT02302079|Drug|ranibizumab|intravitreal (IVT) injection
16080844|NCT02302079|Drug|Placebo|oral capsule
16080845|NCT02302079|Other|Sham intravitreal (IVT) injection|intravitreal (IVT) injection
16080846|NCT02302066|Biological|Takeda's Tetravalent Dengue Vaccine Candidate (TDV)|TDV subcutaneous injection
16080847|NCT02302066|Biological|TDV Placebo|Placebo-matching vaccine
16080848|NCT02302053|Dietary Supplement|New Viviscal Professional Supplement|The key ingredient is AminoMar C™ marine complex, an organic form of silica derived from Equisetum sp. (horsetail), vitamin C derived from Malpighia emarginata (acerola cherry), microcrystalline cellulose (E460), natural orange flavor, magnesium stearate, hypromellose, and glycerol. The AminoMar C ™ is an active ingredient which has been trademarked and comprises of a proprietary blend of shark powder and mollusc powder. It is derived from sustainable marine sources. Viviscal provides essential nutrients to nourish hair naturally from within. The Viviscal supplement is compared to the placebo tablet which contains no active ingredients. One tablet is taken by mouth in the morning and evening with food.
16080849|NCT02302053|Dietary Supplement|Placebo tablets|The placebo tablet contains no active ingredients. One tablet is taken by mouth in the morning and evening with food.
16080850|NCT02302040|Behavioral|AIM2ACT|AIM2ACT is a mobile health tool that is designed to facilitate collaborative asthma management between early adolescents and their caregivers.
16080851|NCT02302040|Behavioral|Self-guided|Paper feedback and collaborative asthma management strategies are provided to early adolescents and caregivers.
16080852|NCT02302027|Device|platinium IRC9LXO2AWQ|high flow concentrator delivering normobaric oxygen after extraction, 9 liter per minute dimensions: 46 * 67 * 36 cm
16080853|NCT02302014|Other|Palliative Care Intervention|Baseline interview with trial cardiologist and trial nurse lasting for up to 1 hour Creation of a Future Care Plan (FCP) document following this baseline interview Sharing of FCP document with primary care and unscheduled care organisations 6 week interview with trial nurse lasting for up to 1 hour to review FCP 12 week interview with trial nurse lasting for up to 1 hour to review FCP Continuous access to trial nurse by mobile telephone 9am - 5pm Monday-Friday for 12 weeks Trial nurse will - ensure FCP is appropriately shared with primary and secondary care, patient is registered on primary care palliative care register and will liaise with specialist PC services and the general practitioner as needed.
16080854|NCT02302001|Device|Silicone Implant|
16080855|NCT02301988|Drug|Ipatasertib|Ipatasertib will be administered at a dose of 400 milligrams (mg) orally daily on Days 1-21 of each 28-day cycle for 3 cycles.
16080856|NCT02301988|Drug|Paclitaxel|Paclitaxel will be administered at a dose of 80 milligrams per square meter (mg/m^2) as IV infusion QW for 3 cycles.
16080857|NCT02301988|Drug|Placebo|Participants will receive placebo (matching to ipatasertib) orally daily on Days 1-21 of each 28-day cycle for 3 cycles.
16080858|NCT02301975|Drug|Fluticasone Furoate/Vilanterol 100/25 mcg via ELLIPTA inhaler|FF/Vilanterol 100/25 mcg inhalation powders administered once daily via ELLIPTA inhaler. 30 doses per device and 100/25 mcg per actuation.
16080859|NCT02301975|Drug|Placebo inhalation powders via ELLIPTA inhaler|Placebo inhalation powders administered once daily via ELLIPTA inhaler. 30 doses per device.
16080860|NCT02301975|Drug|Fluticasone Propionate/Salmeterol 250/50 mcg via ACCUHALER/DISKUS inhaler|FP/Salmeterol 250/50 mcg inhalation powder administered twice daily via ACCUHALER/DISKUS inhaler. 60 doses per device and 250/50 mcg per actuation.
16080861|NCT02301975|Drug|Placebo inhalation powder via ACCUHALER/DISKUS inhaler|Placebo inhalation powder administered twice daily via ACCUHALER/DISKUS inhaler. 60 doses per device.
16080862|NCT02301975|Drug|Fluticasone Propionate 250 mcg via ACCUHALER/DISKUS inhaler|FP 250 mcg inhalation powder administered twice daily via ACCUHALER/DISKUS inhaler. 60 doses per device and 250 mcg per actuation.
16080863|NCT02301962|Drug|Panitumumab|Panitumumab is available as a concentrate for solution for infusion (sterile concentrate). It is a colorless solution that may contain, translucent to white, visible amorphous, proteinaceous panitumumab particles. Each milliliter (mL) of concentrate contains 20 mg panitumumab. Each vial contains 100 mg of panitumumab in 5 mL.
16080864|NCT02301949|Drug|Thalidomide|Patients are randomly assigned to receive a second course of four-month treatment of thalidomide (Pharmaceutical Co., Ltd. of ChangZhou, China). Medications are taken orally 25mg four times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m.
16080865|NCT02301949|Other|Placebo|Patients are randomly assigned to receive placebo tablets (Pharmaceutical Co., Ltd. of ChangZhou, China) four times daily at 6 a.m., 12 noon, 6 p.m., and 10 p.m.
16080866|NCT02301936|Drug|LDV/SOF|90/400 mg fixed dose combination (FDC) tablet administered orally once daily
16080868|NCT02301910|Drug|Tenecteplase|"50 mg of drug reconstituted in 10 ml sterile water for injection given as single weight-adjusted i.v. bolus over 5 - 10 seconds Weight (kg) Dose (mg) Dose (ml)
~55 to <60 30 mg 6 ml
~60 to <70 35 mg 7 ml
~70 to <80 40 mg 8 ml"
16080869|NCT02301897|Drug|Telapristone Acetate|Telapristone acetate, orally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
16080870|NCT02301897|Drug|Placebo|Matching placebo, orally, once daily for 18 weeks (Course 1) and repeated for an additional 18 weeks (Course 2) following the ODI.
16080871|NCT02301884|Biological|Allergen extract|Causal allergen extract such as D. farinae, D. pteronyssinus, cat hair, dog hair/dander, or combination of those
16080872|NCT02301871|Device|Dr. Gene's Health and Wellness|The device is used to perfom deep neck flexors muscles traning. These low load craniocervical flexion exercise are even in early stages of rehabilitation when pain or pathology might preclude high load exercises and thus gradually reduces the symptoms.
16080873|NCT02301871|Procedure|Muscle Energy Technique|MET was applied to Upper trapezius, Levator scapulae and Scalene Following the 7-10 seconds isometric contraction and complete relaxation of all elements, the stretch is maintained for 30 seconds. The effort and the counter-pressure should be modest (20% of available strength) and painless. The process is repeated 3-5 times.
16080874|NCT02301871|Procedure|Static stretching and Cervical non thrust manipulation|conventional treatment for 5 days per week for 2 weeks such as MHP (Moist Heat Pack) for 20 minutes, Static Stretching exercises for upper trapezius, levator scapulae and scalene muscle which is held for 10-30 seconds- repeated 3-5 times, Cervical spine non-thrust mobilization (Grade 3) was given to each segment from C2-C7 was oscillated for 10 repetitions, followed by a 10 seconds rest between segments, Cervical spine active ROM (Range of Motion) exercises with 10 repetitions- 2-3 times a day and Postural exercises were given as home programme.
16080875|NCT02301858|Genetic|Genome analysis of tissue samples.|Genome analysis of tissue samples.
16080876|NCT02301845|Drug|Diatoms Shells|Instillation of suspended diatom shells - 10 mg q12h
16080877|NCT02301819|Device|Veno-arterial extracorporeal membrane oxygenation (ECMO)|Veno-arterial extracorporeal membrane oxygenation (ECMO) will be ineserted as soon as possible and set to achieve adequate organ and tissue perfusion.
16080878|NCT02301819|Other|Early conservative therapy according to standard practice|Standard therapy including inotropes and vasopressors will be used to achieve hemodynamic stabilization and adequate tissue perfusion.
16080879|NCT02301806|Other|dieting|
16080880|NCT02301806|Drug|Sitagliptin|sitagliptin 50 mg tablet by mouth 12 weeks
16080881|NCT02301806|Drug|Glimepiride|glimepiride 1 mg tablet by mouth 12 weeks
16080882|NCT02301793|Behavioral|Nurse education in contemporary format|Education about VTE was delivered through a web-based contemporary interactive format
16080883|NCT02301793|Behavioral|Nurse education in traditional format|Education about VTE was delivered through a web-based traditional linear Powerpoint format with voice over.
16080884|NCT02301780|Drug|Aspirin|"Participants who are screened with a high-risk of developing PET will be randomised into one of 2 arms of the trial (on the same day as screening or within 1 week of the screening visit). Randomised participants will be advised to start 150mg of Aspirin/Placebo once per night within 24 hours of randomisation until 36 weeks' gestation or when signs of labour commence.
~The maximum duration for aspirin or placebo intake will be 180 days."
16080885|NCT02301780|Drug|Placebo|"Participants who are screened with a high-risk of developing PET will be randomised into one of 2 arms of the trial (on the same day as screening or within 1 week of the screening visit). Randomised participants will be advised to start 150mg of Aspirin/Placebo once per night within 24 hours of randomisation until 36 weeks' gestation or when signs of labour commence.
~The maximum duration for aspirin or placebo intake will be 180 days."
16080886|NCT02301754|Biological|INVAC-1|intradermal injection combined with electroporation
16080887|NCT02301741|Behavioral|Game|We will assess the influence of participation in a computer game of virtual dodge ball that requires whole-body reaching movements to manipulate an on-screen avatar. We will gradually reduce the gain of lumbar spine motion of the participant's on-screen avatar across the three game sessions such that participants will need to produce progressively larger excursions of the lumbar spine to manipulate their avatar's spinal motion. Specifically, in game session 1, the spine motion of the avatar is equal to that of the participant (gain=1); in session 2 spine motion of the avatar is 5% less than the participant (gain=0.95); in session 3 spine motion of the avatar is 10% less than the participant (gain=0.90).
16080888|NCT02301728|Other|sampling of breast milk, obtaining information about the maternal diet|take samples of 3 ml breast milk and 3-days diet diaries
16080889|NCT02301715|Drug|Oxytocin|OT spray will be performed by the research pharmacy at the University Regional Hospital Pharmacy of Besançon. The placebo contained all inactive ingredients except for the neuropeptide. Placebo and OT spray containers will be prepared to look identical and will be counterbalance to be randomly assigned by the pharmacy as well. Double blinding and randomization of patients in the two groups will also be carried out by the pharmacy service. Researchers, as well as participants, will be blinded to the content of the spray. Participants will be instructed to sit and take one puff every 30 seconds, alternating nostrils. Participant will take each dose in front of the clinician to assure correct administration and tolerability.
16080890|NCT02301715|Drug|Placebo|The placebo contained all inactive ingredients except for the neuropeptide. Participants will be instructed to sit and take one puff every 30 seconds, alternating nostrils. Participant will take each dose in front of the clinician to assure correct administration and tolerability.
16080891|NCT02301702|Biological|Tdap|Commercially available, U.S. and Guatemala licensed, 0.5mL intramuscular injection combination tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine
16080892|NCT02301702|Biological|Td|The tetanus toxoid and reduced diphtheria toxoid vaccine (Td) used for this study will be the same preparation used by the National Immunization Program of Guatemala
16080893|NCT02301676|Behavioral|Korean version of telephone interview for cognitive status|The telephone interview for cognitive status (TICS), developed by Brandt et al. (1988), is one of the most popular telephone interview-based screening instruments. Especially, the Korean version of TICS is translated more suitable for Korean culture with the permission of the authors of the original version. The Korean version of TICS consists of 11 items, total score is 41.
16080971|NCT02301169|Drug|Administration of T4P1001 capsules|This treatment is given as add on therapy to patients' regular analgesic
16080894|NCT02301676|Drug|Sevoflurane|Sevoflurane is one of the most commonly used volatile anesthetic agents, particularly for outpatient anesthesia, and including in anesthesia of children and infants, and in veterinary medicine.
16080895|NCT02301676|Drug|propofol|Propofol is highly protein-bound in vivo and is metabolized by conjugation in the liver. The half-life of elimination of propofol has been estimated to be between 2 and 24 hours.
16080896|NCT02301676|Device|dexmedetomidine|Dexmedetomidine is a sedative medication used by intensive care units and anesthesiologists. It is relatively unusual in its ability to provide sedation without causing respiratory depression.
16080897|NCT02301663|Other|Handgrip|Subjects will be asked to squeeze and handgrip dynamometer to increase cardiac metabolic demand
16080898|NCT02301663|Other|Altitude simulation|Subjects will breathe a lower concentration of oxygen to simulate the effects of altitude.
16080899|NCT02301663|Other|Leg exercise|Subjects will perform leg exercise to increase metabolic demand.
16080900|NCT02301650|Drug|Lamivudine|mothers use Lamivudine in late pregnancy
16080901|NCT02301650|Drug|Telbivudine|mothers use Telbivudine in late pregnancy
16080902|NCT02301650|Drug|Tenofovir|mothers use Tenofovir in late pregnancy
16080903|NCT02301637|Device|Eeva™ Test|The Eeva System is indicated to provide adjunctive information on events occurring during the first two days of development that may predict further development to the blastocyst stage on Day 5 of development. This adjunctive information aids in the selection of embryo(s) for transfer on Day 3 when, following morphological assessment on Day 3, there are multiple embryos deemed suitable for transfer or freezing.
16080904|NCT02301624|Biological|Eculizumab|Intravenous administration of eculizumab.
16080905|NCT02301624|Drug|Placebo|Intravenous administration of matching placebo. Participants received placebo only during the Blind Induction Phase.
16080906|NCT02301611|Drug|TLPLDC|Autologous tumor lysate, particle-loaded dendritic cell vaccine
16080907|NCT02301611|Drug|Placebo|
16080908|NCT02301598|Procedure|FS-ALK (Femtolaser-assisted anterior lamellar keratoplasty)|The procedure was a non-penetrating transplantation of 80% thickness corneal graft
16080909|NCT02301585|Procedure|Passive Leg Raising Test|Before decision on fluid administration a passive leg raising test is performed. The results are interpreted according to a treatment protocol. If the test indicates fluid irresponsiveness optimization of circulation will be done with vasopressors or inotropes.
16080910|NCT02301585|Procedure|Standard of care|Patients are treated according to Surviving Sepsis Guidelines
16080911|NCT02301559|Behavioral|Pilates exercises|Pilates exercises with emphasis on pelvic region
16080912|NCT02301546|Behavioral|computerized cognitive exercises|Each group will perform computerized cognitive exercises, 1 hour per day, 3 - 5 days per week, for 13 weeks. The experimental group will use exercises shown to improve cognition, whereas the comparator group will use exercises without clear beneficial findings.
16080913|NCT02301533|Behavioral|Shikamana Intervention|See arm description
16080914|NCT02301533|Behavioral|Standard Care|See arm description
16080915|NCT02301507|Behavioral|cell phone SMS text messaging|This study will utilize mobile texting services to send text messages to enrolled subjects on a weekly basis. The text would convey messages that promote better awareness and knowledge on HIV and its treatment, reminders for medication adherence and clinic appointments. The text content would also be customized based on individual subject requirements. English will be used in texting. We would also assess the subjects for traditional demographic items (e.g., age, marital status, education, number/age of other children, employment, and religion), and potential environmental barriers (e.g., transportation and childcare).
16080916|NCT02301494|Drug|3.75% Imiquimod Cream|CTCL specific assessments to measure response in lesions will be done at each visit. Therapy initiates at day 1 followed by a visit at day 15. Visits will then be once a month for four months with a follow up at 6 and 12 months.
16080917|NCT02301494|Drug|0.1% Fluocinonide Cream|CTCL specific assessments to measure response in lesions will be done at each visit. Therapy initiates at day 1 followed by a visit at day 15. Visits will then be once a month for four months with a follow up at 6 and 12 months.
16080918|NCT02301481|Radiation|SIB-IMRT|45.1Gy and 40.04Gy in 22 fractions using intensity-modulated radiotherapy with a simultaneous integrated boost (SIB-IMRT) to primary tumor
16080919|NCT02301481|Drug|S-1|40mg/m2, orally twice daily every weekday concurrently with radiotherapy treatment
16080920|NCT02301481|Procedure|Surgery|Surgery, preferred D2 lymphadenectomy
16080921|NCT02301481|Drug|SOX|SOX (S-1: 40~60mg, orally twice daily on days 1 to 14, oxaliplatin 130mg/m2 intravenously on day 1, 21 days per cycle)
16080922|NCT02301468|Other|Dry Needling|(experimental- physiotherapy intervention) - will be performed during 4 weeks (1 treatment/week) on the 4 most painful trigger points (determined/selected at the first session - see above). The same 4 trigger points will be treated during the 4 weeks. DN will be performed by locating the taut band and the trigger point. Once the trigger point is located, the overlying skin will be cleaned with alcohol. A certified and experienced therapist will penetrate the needle through the skin 10-15mm. into the TrP until the local twitch response will be obtained.
16080923|NCT02301468|Other|Ischemic Compression|(experimental - physiotherapy intervention) will be performed during 4 weeks (1 treatment/week) on the 4 most painful trigger points (determined/selected at the first session - see above). IC will be performed by applying a pressure with a wooden stick on the 4 individually determined most painful trigger points. The duration of the pressure will be about 60s, (increase of pressure 10N/s) until the highest tolerable pressure will be reached and this pressure will be held even when the pain is decreasing during the intervention. The subject will always be treated by the same clinician.
16080924|NCT02301455|Behavioral|Text messaging|persistently hypertensive participants will be randomized to receive these tailored, motivational text messages
16080925|NCT02301442|Behavioral|Exercise + behaviour change intervention|In addition to the same exercise intervention as the control group, this group will receive a behaviour change intervention. This will be delivered after each exercise session and will incorporate the elements: self-efficacy, outcome expectations, impediments and goal-setting. On the weeks when the participants do not attend group sessions, they will receive telephone calls from physiotherapists. This will consist of guided conversations that consider content delivered in previous sessions.
16080972|NCT02301169|Behavioral|Heat pain stimuli B|
16080973|NCT02301169|Behavioral|Video B|
16080926|NCT02301442|Behavioral|Exercise + control education|The control group will receive exercise and education components. The exercise intervention includes aerobic & strengthening components and are in line with MS exercise guidelines (Latimer-Cheung et al 2013). The aerobic activity is walking, measured using pedometers & exercise logs. The strengthening programme consists of 10 exercises targeting major muscle groups for the upper and lower extremities using elastic resistance band. Over the 10-week programme participants will attend 6 group exercise class, supplemented with telephone calls in the weeks without classes. After each group exercise class this group will receive an education session about the following: diet, vitamin D, sleep, temperature and hydration, and immunisations and vaccinations.
16080927|NCT02301429|Device|Model 20105|implant and follow-up of study device
16080928|NCT02301416|Drug|Phentermine/topiramate|Minimum of 3 months on Qsymia (7.5/46 mg) prior to scheduled weight loss surgery and continuance of up to 24 months of Qsymia after scheduled weight loss surgery.
16080929|NCT02301416|Other|low calorie diet|The low-calorie diet will be individually tailored based on initial resting metabolic rate measurement and co-morbid conditions.
16080930|NCT02301403|Drug|Nicotine patch|8 weeks of nicotine patch
16080931|NCT02301403|Behavioral|in-person counseling and quitline counseling|a single brief, in-person counseling session plus a faxed referral to the Wisconsin Tobacco Quit Line (WTQL), for counseling, including the QUITNOW app and the Website
16080932|NCT02301403|Drug|Preparation Nicotine Mini-Lozenges|Nicotine lozenge prior to attempting to quit smoking
16080933|NCT02301403|Drug|Combination NRT (nicotine patch + nicotine mini-lozenges)|26 weeks of combination NRT as part of a quit smoking attempt
16080934|NCT02301403|Behavioral|Intensive In-Person Cessation Counseling|three 20-min In-person Cessation Counseling sessions
16080935|NCT02301403|Behavioral|Extended Maintenance Counseling Calls|8 Maintenance-phase smoking cessation counseling sessions
16080936|NCT02301403|Behavioral|Automated Adherence Calls|11 brief, automated calls reminding them to use their medications properly
16080937|NCT02301390|Drug|Amiodarone|Amiodarone is a Class III antiarrhythmic agent.
16080938|NCT02301390|Device|Catheter Ablation|The ablation procedure uses radiofrequency energy to destroy cardiac tissue at the origin of the arrhythmia.
16080939|NCT02301377|Device|Spiro PD personal spirometer|
16080940|NCT02301364|Drug|Buparlisib (BKM120)|Buparlisib 100 mg once daily.
16080941|NCT02301351|Other|Graphic Warning Label|All packs provided will include FDA-approved graphic warning labels
16080942|NCT02301351|Other|Text Warning Label|All packs provided will include standard text warning labels
16080943|NCT02301338|Other|Usual care|
16080944|NCT02301338|Other|Phone Calls|
16080945|NCT02301325|Behavioral|Smoking research cigarettes with or without NRT|
16080946|NCT02301312|Device|POSS-PCU vascular graft|New vascular access graft
16080947|NCT02301299|Behavioral|Community-based Stroke Awareness Program|A culturally-adapted stroke awareness and action program will be delivered by trained Stroke Promoters in the targeted neighborhoods in the south side of Chicago. Community Stroke Promoters will be trained on 1) the benefits of early recognition and EMS utilization for stroke (i.e. stroke centers, tPA), 2) culturally-adapted solutions to current barriers (i.e. misperceptions about vulnerability, severity, mistrust, costs), and 3) cues to aid in stroke recognition and immediate action. The intervention will take place at community settings throughout a 1-year period.
16080948|NCT02301286|Drug|Acetylsalicylic acid|
16080949|NCT02301286|Drug|Placebo Acetylsalicylic acid|
16080950|NCT02301273|Other|Usual Physiotherapy|o Patients will receive the usual physiotherapy treatment in ICU in Iceland from day 5 after intubation, which adheres to international standards of practice, including the potential for no treatment. Usual physiotherapy once daily for 20 minutes.
16080951|NCT02301273|Other|Enhanced Physiotherapy|o Patients will receive the intervention physiotherapy treatment consisting of exercises and a progressive upright positioning and mobilization (20 minutes) twice daily from day 3 (>48 hours) after intubation including the potential for no treatment, if they are stable, even though they are not completely alert, Total treatment time of 40 minutes.
16080952|NCT02301260|Behavioral|Speed of Processing Training (SPT)|
16080953|NCT02301260|Behavioral|Placebo Control|Placebo control exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).
16080954|NCT02301247|Behavioral|Memory retraining exercises|Memory retraining exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).
16080955|NCT02301247|Behavioral|Placebo control memory exercises|Placebo control memory exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).
16080956|NCT02301234|Drug|Placebo|Placebo will be administered once every 4 weeks with or without adjunctive therapy for 16 weeks by subcutaneous (SC) injection (injection under the skin) into the thigh or abdomen.
16080957|NCT02301234|Drug|Fulranumab 1 mg|Fulranumab will be administered once every 4 weeks with or without adjunctive therapy for up to 16 weeks by SC injection into the thigh or abdomen.
16080958|NCT02301234|Drug|Fulranumab 3 mg|Fulranumab will be administered once every 4 weeks with or without adjunctive therapy for up to 16 weeks by SC injection into the thigh or abdomen.
16080959|NCT02301234|Drug|Celecoxib 100 mg|Double-blind capsules taken twice daily for up to 16 weeks.
16080960|NCT02301234|Drug|Celecoxib 100 mg Matching Placebo|Double-blind capsules taken twice daily for up to 16 weeks.
16080961|NCT02301221|Procedure|Fecal microbiota transplantation (FMT)|Standardized Frozen Fecal Microbiota will be infused via nasointestinal tube.
16080962|NCT02301221|Drug|Vancomycin and bowel lavage|An initial vancomycin regimen (500 mg orally two times per day for 3 days), followed by bowel lavage before the infusion of a solution of donor fecal microbiota.
16080963|NCT02301208|Drug|Nedaplatin|Nedaplatin combine with IMRT
16080964|NCT02301208|Drug|Cisplatin|Cisplatin combine with IMRT
16080965|NCT02301195|Other|Therapeutic horseback riding|Inclusion of horses as part of the therapeutic experience
16080966|NCT02301195|Other|Barn Activity Intervention|Equine-focused educational activities in small group setting without horses
16080967|NCT02301182|Device|ADM X3-MoP Cup|
16080968|NCT02301182|Device|CoC Cup|
16080969|NCT02301169|Behavioral|Heat pain stimuli A|
16080970|NCT02301169|Behavioral|Video A|
16080983|NCT02301130|Biological|MEDI4736 (Durvalumab)|MEDI4736 will be administered intravenously (IV).
16080984|NCT02301130|Biological|tremelimumab|Tremelimumab will be administered intravenously (IV).
16080985|NCT02301117|Drug|TAS-102|
16080986|NCT02301104|Drug|TAS-102|
16080987|NCT02301091|Procedure|TACE|TACE will be done according to the current method in our center. We use intra-injection of lipiodol mixed with pirarubicin,mitomycin and lobaplatin when the catheter was placed in the superselective location very close to the tumor. Gelfoam sponge was then injected to temporarily occlude the arterial blood flow.
16080988|NCT02301091|Procedure|RFA|For RFA, we used two commercially available system (Cool-Tip, Valleylab，USA) and (Octopus RF Systema，Starmed,Korea）with needle electrode with a 17-gauge internally cooled electrode.
16080989|NCT02301091|Drug|pirarubicin,mitomycin and lobaplatin|They were cytotoxic drugs used in the TACE procedure.
16080990|NCT02301078|Procedure|Percutaneous Needle Aponeurotomy|single procedure (day 0)
16080991|NCT02301078|Drug|Collagenase clostridium histolyticum|Xiaflex injection into palpable cords (day 0), physical manipulation (day 7)
16080992|NCT02301052|Drug|Leek topical cream|Leek (Allium Ampeloprasum Spp.Iranicum) topical cream 2 cc twice daily for 3 weeks
16080993|NCT02301052|Drug|placebo topical cream|placebo topical cream 2 cc twice daily for 3 weeks
16080994|NCT02301052|Drug|Anti-hemorrhoid topical cream|Anti hemorrhoid topical cream 2 cc twice daily for 3 weeks(This cream consists of lidocaine (5% w/w), hydrocortisone acetate (7.5% w/w), aluminium sub-acetate (3.5% w/w), and zinc oxide (18% w/w). 30 g )
16080995|NCT02301039|Drug|Pembrolizumab|
16080996|NCT02301026|Drug|5% Iron Isomaltoside 1000|Administered according to local routines and product labeling in doses at the doctors discretion
16080997|NCT02301013|Procedure|Urinary incontience surgery|Surgery for stress or mixed urinary incontience
16080998|NCT02301013|Drug|300 cc saline|
16080999|NCT02301000|Biological|Intestinal microbiota therapy|60 ml of ACHIM suspension will be administered through a rectal tube
16081000|NCT02301000|Drug|Metronidazole|Peroral metronidazole 400 mg t.i.d. for ten days
16081001|NCT02300987|Drug|LEE011|
16081002|NCT02300987|Drug|LEE011 Placebo|
16081003|NCT02300961|Behavioral|Cognitive rehabilitation program|
16081004|NCT02300948|Drug|PregVit® contains 1.1 mg of folic acid|Participants are randomly allocated to one of two groups: PregVit-Folic 5® (group1) contains 5 mg folic acid or PregVit® (group 2) contains 1.1 mg folic acid.Both supplements are taken as 2 tablets daily, one tablet in the morning (am) and one tablet in the evening (pm). Both multivitamins are appropriate for periconceptional, prenatal, and post-partum supplementation. The total volume of blood that will be taken is approximately 20 mL (4 teaspoons). Each appointment will be scheduled according to when participants are available. To monitor adherence, the PregVit-Folic 5® blister packs should be returned among with a diary of pill intake (will be provided). To document dietary folate, telephone interviews regarding the diet will be conducted.
16081005|NCT02300948|Drug|PregVit-folic 5® contains 5 mg of folic acid|Participants are randomly allocated to one of two groups: PregVit-Folic 5® (group1) contains 5 mg folic acid or PregVit® (group 2) contains 1.1 mg folic acid.Both supplements are taken as 2 tablets daily, one tablet in the morning (am) and one tablet in the evening (pm). Both multivitamins are appropriate for periconceptional, prenatal, and post-partum supplementation. The total volume of blood that will be taken is approximately 20 mL (4 teaspoons). Each appointment will be scheduled according to when participants are available. To monitor adherence, the PregVit-Folic 5® blister packs should be returned among with a diary of pill intake (will be provided). To document dietary folate, telephone interviews regarding the diet will be conducted.
16081006|NCT02300935|Drug|trametinib|
16081007|NCT02300935|Drug|nab-paclitaxel|
16081008|NCT02300922|Drug|Antibody TF2|injection of a recombinant antibody CEA specific. Three injections. Each injection are separate by one week
16081009|NCT02300922|Drug|90-Y-IMP-288|Injection of the peptide 90-Y-IMP-288, 24 Hours after injection of TF2. 2 injections by patients separated by one week (week 2 and week 3)
16081010|NCT02300922|Drug|111-In-IMP-288|Injection of the peptide 111-In-IMP-288, 24 Hours after the first injection of TF2 (week 1)
16081011|NCT02300909|Procedure|Lumbar Decompression Surgery|Lumbar Decompression Surgery
16081012|NCT02300909|Procedure|Microdiscectomy Surgery|Microdiscectomy Surgery
16081013|NCT02300909|Other|Dehydrated Human Amnion/Chorion Membrane (dHACM)|Application of Dehydrated Human Amnion/Chorion Membrane (dHACM)
16081014|NCT02300896|Other|Group-based exercise training during hospitalization|Exercise training. Individual program training 5 days a week during hospitalization
16081015|NCT02300870|Drug|Optison|Echocardiogram with IV contrast
16081016|NCT02300857|Behavioral|Low carbohydrate diet|Feeding study. Composition (by proportion of calories): 20% carbohydrate, 60% fat, 20% protein
16081017|NCT02300857|Behavioral|Moderate carbohydrate diet|Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
16081018|NCT02300857|Behavioral|High carbohydrate diet|Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
16081019|NCT02300844|Drug|NNC0174-0833|"Subjects will receive a single s.c. (subcutaneous/under the skin) dose of NNC0174-0833.
~Up to nine dose levels of single s.c. doses of NNC0174-0833 are planned to be investigated."
16081020|NCT02300844|Drug|placebo|Subjects will receive a single s.c. (subcutaneousl/under the skin) dose.
16081021|NCT02300831|Other|Data Collection|Non interventional prospective data collection
16081022|NCT02300818|Device|Pulsed Electromagnetic Field Therapy|Pulsed Electromagnetic Field Therapy widely termed as (PEMF) is a reparative technique used for treatment of eye therapy has proved to be a beneficial treatment for those suffering from glaucoma. This therapy helps in increased blood flow and show positive results on latent, initial and advanced glaucoma with ten sessions of seven minutes' each.
16081023|NCT02300818|Drug|Seawater eyedrops|Eye-drops daily 1 time a day for 12 weeks
16081024|NCT02300792|Dietary Supplement|honey|Each patient in the intervention group (group 1) took oral honey in a dose of 5 ml/kg/day (with a maximum dose of 150 ml/day) for four weeks.
16081025|NCT02300792|Dietary Supplement|molasses|Each patient in the molasses (placebo) group took 5 ml molasses/kg/day for four weeks, with a maximum of 150 ml/day
16081140|NCT02299999|Drug|Olaparib|Target: PARP
16081141|NCT02299999|Drug|Anthracyclines|DNA intercalation
16081026|NCT02300779|Dietary Supplement|Low-residue diet|"Subjects will be instructed by members of the research team to follow a low-residue diet for 4 days.
~Bowel cleansing will begin at 9:00 pm on the evening before the colonoscopy is scheduled. Participants will take 8 sachets of the investigational product and take their contents diluted in 2 liters of water. Eight other sachets, also diluted in 2 liters of water will be taken 4 to 5 hours before the procedure.
~Fasting will be required from 2 hours after the bowel cleansing is complete. Their usual treatment for diabetes (whether insulin or an oral agent) will be adjusted."
16081027|NCT02300779|Dietary Supplement|Usual care|"Subjects will be instructed by members of the research team to follow a low-residue diet for 3 days followed by a liquid-only diet for an additional day.
~Bowel cleansing will begin at 9:00 pm on the evening before the colonoscopy is scheduled. Participants will take 8 sachets of the investigational product and take their contents diluted in 2 liters of water. Eight other sachets, also diluted in 2 liters of water will be taken 4 to 5 hours before the procedure.
~Fasting will be required from 2 hours after the bowel cleansing is complete. No modifications in their usual treatment will be made."
16081028|NCT02300753|Drug|EPI-743|EPI-743 is a quinone oxidation product of alpha-tocotrienol
16081029|NCT02300740|Dietary Supplement|Nicotinamide riboside|NIAGEN, ChromaDex
16081030|NCT02300727|Drug|Curcumin-MTD|0.33g-3g by ingested mouth wash three times per day for 4-6 weeks until unacceptable toxicity develops- to determine the maximum tolerated does (MTD).
16081031|NCT02300727|Drug|Mouthwash-standard pharmacy preparation|"Standard mouth wash preparation administered by ingested mouth rinse three times per day.
~The standard mouth rinse contains 40% Benadryl, 40% Maalox, and 20% of 1% Viscous Lidocaine."
16081032|NCT02300727|Drug|Curcumin|After maximum tolerated dose (MTD) is determined, MTD by ingested mouth wash three times per day for 4-6 weeks until mucositis is resolved, disease progression, or unacceptable toxicity develops.
16081033|NCT02300714|Procedure|oblique view approach|
16081034|NCT02300701|Drug|Xolair|According to manufacturer's instructions
16081035|NCT02300701|Drug|Placebo|Placebo
16081036|NCT02300688|Drug|Treatment A|administration of 1 time administration of the test drug (Treatment A)
16081037|NCT02300688|Drug|Treatment B|administration of 1 time administration of the reference drug (Treatment B)
16081038|NCT02300675|Behavioral|therapeutic education program|
16081039|NCT02300662|Device|Cycle Ergometer|Passive movement of the cycle ergometer will execute alternate flexions and extensions of the patients' knee and hips bilaterally for 20 minutes consecutively.
16081040|NCT02300662|Other|Conventional physiotherapy|Manual bronchial hygiene exercises: vibrocompression, manoeuvres with a manual resuscitator (bag squeezing) and aspiration of secretions where necessary.
16081041|NCT02300649|Drug|Dexmedetomidine, Transesophageal echocardiography(TEE)|Dexmedetomidine will be infused at a rate of 6 mcg/kg/hr for 10 minutes; resulting in a loading dose of 1 mcg/kg, followed by an infusion of 0.5 μg/kg/hr for 50 minutes.
16081042|NCT02300649|Drug|Saline will be infused for 60 minutes at the same rates as dexmedetomidine group.|
16081043|NCT02300636|Other|Training|Co-contraction training at 60 knee flexion angle by using isokinetic dynamometer
16081044|NCT02300636|Other|Training|Co-contraction training at 60 knee flexion angle by using leg press machine
16081045|NCT02300636|Other|Training|Standard ACL rehabilitation
16081046|NCT02300623|Drug|Antiretroviral therapy plus Interleukin-2|Daily s.c. IL-2: 750,000 UI/m2/day for 6 months
16081047|NCT02300623|Drug|Antiretroviral therapy alone|Standard antiretroviral therapy
16081048|NCT02300610|Drug|Enzalutamide|Enzalutamide orally once a day. Dose Escalation Level 1: 80 mg; Level 2: 160 mg. Dose Expansion at recommended dose level, after dose escalation.
16081049|NCT02300610|Drug|Cisplatin|Cisplatin at 70 mg/m^2 IV on day 1, repeated every 21 days for total of 6 cycles.
16081050|NCT02300610|Drug|Gemcitabine|Gemcitabine at 1000 mg/m^2 IV on days 1, 8, repeated every 21 days for total of 6 cycles.
16081051|NCT02300597|Other|Internet based support and coaching|Young people between age 15 and 25 with ADHD and/or autism spectrum disorders are offered internet-based support and coaching during eight weeks (chat and e-mail). Data is collected before and after the intervention and six months after end of treatment using self-report questionnaires pertaining to sense of coherence, self-esteem, quality of life, depressive and anxiety symptoms and socioeconomic status. Parents complete an assessment scale for the next of kin. After treatment the young people are interviewed regarding the quality of the intervention.
16081052|NCT02300584|Behavioral|Tele-Savvy|as a program delivered on an iPad with daily instructional video segments (8-12 minutes each)
16081053|NCT02300584|Behavioral|Tele-Savvy|as a program delivered on an iPad with daily instructional video segments (8-12 minutes each). Videos may be modified after feedback from Prototype arm.
16081054|NCT02300584|Other|iPad|a tablet computer with an internet connection
16081055|NCT02300558|Drug|Eleclazine|Tablets administered orally
16081056|NCT02300558|Drug|Eleclazine placebo|Tablets administered orally
16081057|NCT02300545|Drug|Pazopanib|
16081058|NCT02300532|Other|No intervention|
16081059|NCT02300519|Other|blood sampling|Samplings will be taken on 4 citrated S-monovette tubes, 3 citrated tubes and 1 EDTA tube, namely 36.5 ml for each volunteer
16081060|NCT02300506|Other|No intervention|
16081061|NCT02300493|Behavioral|Experimental|Asked to weigh themselves
16081062|NCT02300480|Procedure|CTB group|CTB: A single injection of 1.0% 10ml ropivacaine by bile duct needle in calot's triangle when before surgical dissection.After surgery,participants in this group will also receive PCIA.
16081063|NCT02300480|Procedure|PCIA group|The formula of the PCIA included tramadol 800 mg, flurbiprofen axetil 100mg with saline added up to a volume of 80 ml in total. The PCIA pump was set up with a 5 ml loading dose, a 2 ml bolus dose, a 15 min lockout interval and background infusion at a rate of 1 ml/h.
16081064|NCT02300467|Drug|NOV120401|5 to 45 mg/day PO for 5 consecutive days and 2 days off
16081065|NCT02300454|Device|Non-slip element balloon (NSE)|Lacrosse® NSE and SeQuent® Please drug coated balloon (DCB)
16081066|NCT02300454|Device|Balloon|Non-compliant balloon and SeQuent® Please drug coated balloon (DCB)
16081067|NCT02300441|Other|ECG, blood pressure and oximetry|
16081068|NCT02300428|Dietary Supplement|oral iron|BNF code for section 9.1.1.1 (Oral iron preparations for iron-deficiency anaemias)
16081069|NCT02300415|Biological|blood sample|Dosage of presepsine
16081070|NCT02300389|Radiation|Hypofractionated IMRT boost radiotherapy|All patients included into this arm are irradiated to 46 Gy a 2 Gy fraction to the whole pelvis and seminal vesicles and prostate gland (I phase) and than the boost dose is limited to the prostate gland with some part of seminal vesicles with hypofractionated dose of 7.5 Gy in two fractions (II phase) to the total dose of 61 Gy. Additionally all patients received neoadjuvant Androgen Deprivation Therapy (3-4 months prior starting radiotherapy) and during radiotherapy and during the follow-up up to 24 months.
16081071|NCT02300389|Radiation|Conventional Fractionated IMRT boost radiotherapy|All patients included into this arm are irradiated to 46 Gy a 2 Gy fraction to the whole pelvis and seminal vesicles and prostate gland (I phase) and than the boost dose is limited to the prostate gland with some part of seminal vesicles with conventional fractionated dose of 2 Gy in 15 fractions (II phase) to the total dose of 76 Gy. Additionally all patients received neoadjuvant Androgen Deprivation Therapy (3-4 months prior starting radiotherapy) and during radiotherapy and during the follow-up up to 24 months.
16081072|NCT02300376|Drug|Dosage of Calcium edetate de sodium|There is no medical data for the use of Calcium edetate de sodium as a tracer to assess GFR. Calcium edetate de sodium is a treatment for lead intoxication. The extension of use as a tracer comes from its exclusive elimination by glomerular filtration. Plasma and renal clearance of Calcium edetate de sodium and Inulin will be measured for every included patient during a hospital day care (V1). For transplanted patients, plasma clearance of Calcium edetate de sodium will be repeated within one week (more or less 48hours) during annual medical check-up of renal transplantation.
16081073|NCT02300363|Drug|Treatment A (rosuvastatin)|10 mg rosuvastatin administered on Day 1 and Day 13
16081074|NCT02300363|Drug|Treatment B (LX4211)|400 mg LX4211 administered on Day 7 through Day 13
16081075|NCT02300363|Drug|Treatment C (rosuvastatin + 400 mg LX4211 administered concomitantly)|10 mg rosuvastatin + 400 mg LX4211 administered concomitantly on Day 13
16081076|NCT02300350|Drug|Treatment A digoxin|0.5 mg digoxin administered on Day 1 and Day 20
16081077|NCT02300350|Drug|Treatment B LX4211|400 mg LX4211 administered daily on Day 14 through Day 25
16081078|NCT02300350|Drug|Treatment C Digoxin + 400 mg LX4211 administered concomitantly|0.5 mg Digoxin + 400 mg LX4211 administered concomitantly on Day 20
16081079|NCT02300337|Device|Reduce Cuff pressure|We reduce the Cuff Pressure from the LTS-D (Laryngeal Tube suction) from 60 to 50 to 40 to 30cmH2O and measure the Delta from Inspiration to Expiration Tidalvolume (Delta Vt). The Delta Vt shows the actual leakage.
16081080|NCT02300324|Dietary Supplement|Standard broccoli and stilton soup|Participants will be randomised to eat one portion (300g) of broccoli soup for each phase.
16081081|NCT02300324|Dietary Supplement|Beneforte broccoli and stilton soup|Participants will be randomised to eat one portion (300g) of broccoli soup for each phase.
16081082|NCT02300324|Dietary Supplement|Beneforte Extra broccoli and stilton soup|Participants will be randomised to eat one portion (300g) of broccoli soup for each phase.
16081083|NCT02300311|Drug|nonivamide + nicoboxil (Finalgon cream)|2 cm cream line for a skin area approximately 20 x 20 cm2 up to 3 times in a 24 hour period
16081084|NCT02300311|Drug|placebo matching nonivamide + nicoboxil (Finalgon cream)|2 cm cream line for a skin area of approximately 20 x 20 cm2 up to 3 times in a 24h period
16081085|NCT02300298|Drug|Nintedanib|Nintedanib
16081086|NCT02300298|Drug|Docetaxel|Docetaxel
16081087|NCT02300285|Device|Continuous Glucose Monitoring|Continuous glucose monitors (CGM) will be used to monitor blood sugar levels in enrolled subjects. CGMs measure blood sugar in the tissue just under the skin every few seconds and report average blood sugar every 5 minutes. In our study, the CGMs will function as monitoring systems. In the CGM protocol group the CGM will let the medical team know if there is a concerning blood sugar level, so that the medical team can then check a blood sugar level by the standard way (usually in a small drop of blood) and then decide if they need to give any medical treatment. In the Standard of Care group the CGM data will not be visible to the medical team but the medical team will be informed by the researchers if there are multiple unrecognized episodes of severe hypoglycemia.
16081088|NCT02300272|Device|Polysomnograph|Participants will be screened for sleep disorders other than chronic insomnia with an in-home overnight sleep monitoring. Monitoring will consist of six electroencephalography (EEG) measures, two electrooculography (EOG), and chin electromyography (EMG) according to standard placements. Other channels will include oxygen saturation level, bilateral anterior tibialis EMG, heart rate (EKG), thoracic strain gauge, and a nasal/oral thermistor. A single night of polysomnography will be collected during the 2 weeks of assessment.
16081089|NCT02300272|Device|Actiwatch|This device will be worn on the wrist for 14 continuous days to measure limb movements and ambient light.
16081090|NCT02300259|Drug|LY2623091|Administered orally
16081091|NCT02300259|Drug|Itraconazole|Administered orally
16081092|NCT02300259|Drug|Simvastatin|Administered orally
16081093|NCT02300259|Drug|Tadalafil|Administered orally
16081094|NCT02300259|Drug|Diltiazem|Administered orally
16081095|NCT02300246|Procedure|Platelet-Rich Fibrin|Alveolar socket preservation with Platelet-Rich Plasma
16081096|NCT02300233|Drug|volanesorsen|300 mg volanesorsen administered subcutaneously once-weekly for 26 weeks
16081097|NCT02300233|Drug|Placebo|Placebo administered subcutaneously once-weekly for 26 weeks
16081098|NCT02300220|Drug|Ciprofloxacin|500 mg, twice daily for 1 week (oral)
16081099|NCT02300220|Drug|Placebo|One capsule, twice daily for 1 week
16081100|NCT02300207|Device|electronic acupuncture treatment instrument|Electroacupuncture was performed using small-sized (1.5 cm) cutaneous electrode pads placed bilaterally at the PC-6 points of the forearms (Supplementary Figure 1). The intensity of the electrical stimulation was adjusted to produce the most intense tolerable electrical sensation without muscle contractions or uncomfortable feelings at a frequency of 50 Hz using the Hwato electronic acupuncture treatment instrument (Model No. SDZ-II; Suzhou Medical Appliances Co, Ltd, Suzhou, China).
16081101|NCT02300194|Drug|Topic Morphine|Topical application of a 0.1% morphine gel in patients undergo a procedure. It will be applied 30 minutes before the procedure and the first day every 4 hours. General basic sedation and systemic analgesia will give for all the patients. Efficacy of treatment will be measured with FLACC scale.
16081142|NCT02299999|Drug|Taxanes|Target: mitotic tubulin and microtubules
16081143|NCT02299999|Drug|cyclophosphamide|Alkylating agents
16081144|NCT02299999|Drug|DNA intercalators|DNA intercalators
16081102|NCT02300194|Drug|Placebo|Topical application of a placebo hydrogel in patients undergo a procedure. It will be applied 30 minutes before the procedure and the first day every 4 hours. General basic sedation and systemic analgesia will give for all the patients. Efficacy of treatment will be measured with FLACC scale.
16081103|NCT02300181|Dietary Supplement|Placebo|
16081104|NCT02300181|Dietary Supplement|Bacillus subtilis var natto DC-15|
16081105|NCT02300168|Procedure|Sleeve gastrectomy|Laparoscopic sleeve gastrectomy (LSG) is a restrictive procedure which consists in creating a narrow tube-like stomach, designed to decrease appetite by reducing the ability of the stomach to distend.
16081106|NCT02300155|Drug|Pregvit®|Women were randomized to one of two groups. An information package was mailed to each woman, instructing her to commence supplementation with her assigned prenatal multivitamin, according to the product's standard dosing -twice daily for '35 mg' group
16081107|NCT02300155|Drug|Orifer F®|Women were randomized to one of two groups. An information package was mailed to each woman, instructing her to commence supplementation with her assigned prenatal multivitamin, according to the product's standard dosing-once daily for '60 mg' group
16081108|NCT02300142|Biological|GEN-003 Vaccine (30μg of each antigen)|HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
16081109|NCT02300142|Biological|GEN-003 Vaccine (60μg of each antigen)|HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
16081110|NCT02300142|Biological|Matrix-M2 Adjuvant (25μg)|Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
16081111|NCT02300142|Biological|Matrix-M2 Adjuvant (50μg)|Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
16081112|NCT02300142|Biological|Matrix-M2 Adjuvant (75μg)|Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
16081113|NCT02300129|Drug|CD07805/47, CD07805/47+Placebo, Placebo, CD07805/47, Placebo|"Period 1:
~1g of CD07805/47 0.5% Gel on full face on Day 1 and 500mg on a half-face on Day 3.
~500mg of Placebo Gel on a half-face on Day 3 and 1g on full face on Day 5.
~Period 2:
~1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks.
~1g of Placebo Gel on full face once daily 7 days per week the 2 following weeks."
16081114|NCT02300129|Drug|Placebo, CD07805/47+Placebo, CD07805/47, CD07805/47, Placebo|"Period 1:
~1g of Placebo Gel on full face on Day 1 and 500mg on a half-face on Day 3.
~500mg of CD07805/47 0.5% Gel on a half-face on Day 3 and 1g on full face on Day 5.
~Period 2:
~1g of CD07805/47 0.5% Gel on full face once daily 7 days per week for 2 weeks.
~1g of Placebo Gel on full face once daily 7 days per week the 2 following weeks."
16081115|NCT02300129|Drug|CD07805/47, CD07805/47+Placebo, Placebo, Placebo, CD07805/47|"Period 1:
~1g of CD07805/47 0.5% Gel on full face on Day 1 and 500mg on a half-face on Day 3.
~500mg of Placebo Gel on a half-face on Day 3 and 1g on full face on Day 5.
~Period 2:
~1g of Placebo on full face once daily 7 days per week for 2 weeks.
~1g of CD07805/47 0.5% Gel on full face once daily 7 days per week the 2 following weeks."
16081116|NCT02300129|Drug|Placebo, CD07805/47+Placebo, CD07805/47, Placebo, CD07805/47|"Period 1:
~1g of Placebo Gel on full face on Day 1 and 500mg on a half-face on Day 3.
~500mg of CD07805/47 0.5% Gel on a half-face on Day 3 and 1g on full face on Day 5.
~Period 2:
~1g of Placebo on full face once daily 7 days per week for 2 weeks.
~1g of CD07805/47 0.5% Gel on full face once daily 7 days per week the 2 following weeks."
16081117|NCT02300103|Drug|SOF/VEL|400/100 mg FDC tablet administered orally once daily
16081118|NCT02300103|Drug|RBV|Tablet (s) administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16081119|NCT02300090|Device|Test Group|Patients receive a mobile phone with the Me & My COPD app installed. Patients also receive a bluetooth inhaler device that is fitted to their usual reliever inhaler.
16081120|NCT02300090|Other|Control Group|Patients in the control group receive only standard care; there are no interventions within this group of patients
16081121|NCT02300077|Drug|methadone|Escalating dose of methadone up to .3mg/kg.
16081122|NCT02300077|Drug|Control (Intra-operative administration of opioids, other than methadone)|Intra-operative administration of opioids, other than methadone
16081123|NCT02300064|Other|Knee-extensor exercise test|Steady-state, single leg knee-extensor exercise at 20 Watts for 10 minutes
16081124|NCT02300064|Other|Exercise test with restricting/releasing blood flow|10 minute submaximal (20 Watts) single leg knee-extensor exercise with blood flow clamped 10-15% lower by arterial infustion of phenylephrine; 10 minute passive single leg knee-extensor exercise with blood flow matched to the 20 Watt work rate level by arterial adenosine infusion; 10 minute seated rest with blood flow matched to the 20 Watt work rate level by adenosine infusion. Each test separated by at least 30 minutes rest.
16081125|NCT02300064|Other|Exercise test with variable oxygen concentration and MRI|Two bouts of single leg knee-extensor exercise to maximal effort breathing regular air (21% oxygen) or 100% oxygen through a mouthpiece, with a 90 minute rest period between each bout. The same experiment performed again on a separate day in an magnetic resonance imaging (MRI) machine
16081126|NCT02300064|Other|Exercise test with oral antioxidant or placebo cocktail|Antioxidants (Vitamin E - 400 international units, Vitamin C - 1000 milligrams and Alpha lipoic acid - 600 milligrams) or matching placebo capsules administered orally followed by femoral nerve stimulation and single leg knee-extensor exercise for 30 minutes at 50% maximum effort
16081127|NCT02300051|Behavioral|STPGP and RPGT|
16081128|NCT02300051|Drug|TAU|
16081129|NCT02300038|Drug|Lidocaine (Xylocaine)|perineuromally administration of 1 ml lidocaine
16081130|NCT02300038|Dietary Supplement|NaCl|perineuromally administration of NaCL
16081131|NCT02300025|Drug|cobimetinib|single oral 10-mg dose of cobimetinib
16081132|NCT02300012|Procedure|Surgeons knowledge of pre-operative PBIs|Surgeon performing ACL repair will have prior knowledge of patients pre-operative PBIs to inform surgical practice
16081133|NCT02299999|Drug|AZD2014|Target: m-TOR
16081134|NCT02299999|Drug|AZD4547|Target: EGFR
16081135|NCT02299999|Drug|AZD5363|Target: AKT
16081136|NCT02299999|Drug|AZD8931|Target: HER2, EGFR
16081137|NCT02299999|Drug|Selumetinib|Target: MEK
16081138|NCT02299999|Drug|Vandetanib|Target: VEGF, EGFR
16081139|NCT02299999|Drug|Bicalutamide|target: Androgen receptor
16081146|NCT02299999|Drug|vinca alkaloids|Target: mitotic tubulin and microtubules
16081147|NCT02299999|Drug|Platinum based chemotherapies|Platinum based chemotherapies
16081148|NCT02299999|Drug|Bevacizumab|Target: VEGF
16081149|NCT02299999|Drug|Mitomycin C|Alkylating agents
16081150|NCT02299999|Drug|Eribulin|Microtubule modulator
16081151|NCT02299999|Drug|MEDI4736|Target: PD-L1
16081152|NCT02299986|Other|Ultrasound measurement|Thickness measurement through ultrasound. The investigators will perform daily ultrasound measurements to assess the evolution in thickness during mechanical ventilation
16081153|NCT02299973|Procedure|FMT with donor stool|fecal microbiota transplantation by means of colonoscopy with deliverance of the transplant in the right colon and terminal ileum. Transplants will be collected prior to the start of the study from a healthy pool of donors and will be frozen at -80 degrees celsius after thorough screening for infectious diseases. At the time of transplantation samples will be frozen and administrated to the patients in the treatment group
16081154|NCT02299973|Procedure|FMT with own stool|fecal microbiota transplantation by means of colonoscopy with deliverance of the transplant in the right colon and terminal ileum. Transplants will be collected prior to the start of the study from the patients and will be frozen at -80 degrees celsius after thorough screening for infectious diseases. At the time of transplantation samples will be frozen and administrated to the patients in the control group
16081155|NCT02299960|Device|Endo-PAT|Analysis of endothelial function through pulse-amplitude-tonometry
16081156|NCT02299960|Device|NICOM|Non-invasive measurement of cardiac output
16081157|NCT02299947|Drug|Haemocomplettan P|
16081158|NCT02299947|Drug|Placebo|
16081159|NCT02299934|Diagnostic Test|Magnetic Resonance Imaging (MRI)|MRI sequences for visualisation of the blood supply of liver without contrast agent.
16081160|NCT02299934|Diagnostic Test|Compurtized Tomgraphy (CT)|CT including CT Angiography (CTA) for the evaluation of hepatic vasculature.
16081161|NCT02299921|Other|Characterize alcohol and drug use|Characterize alcohol and drug use in patients newly admitted to the medical ICU service, who are expected to stay in the ICU for greater than 48 hours. The investigators will collect blood, exhaled breath condensate, urine and hair samples over the first 10 days of hospitalization. A select subset of subjects will have bronchoalveolar lavage (BAL) obtained.
16081162|NCT02299908|Drug|TAP block with Bupivacaine at 0.25%|Application of 20 mL of local anesthetic bupivacaine at 0.25% in the transverse abdominis plane (TAP) under ultrasound guidance. This area (TAP) is between the anterior fascia of the transverse abdominal muscle and the posterior fascia of the internal oblique muscle, through which the thoracic nerve fibers and a portion of the first lumbar pass. This intervention will be done 10 minutes before conducting the ipsilateral inguinal herniorrhaphy in a single application.
16081163|NCT02299908|Drug|Placebo saline solution|Application of 20 mL of saline solution in the transverse abdominis plane (TAP).
16081164|NCT02299882|Drug|Vancomycin|Patient will be randomized to either vancomycin or no vancomycin. This treatment will take place prior to the closure of the incision from back surgery.
16081165|NCT02299869|Device|Verde (Competitor-control)|contact lens
16081166|NCT02299869|Device|Green (CVI-test)|contact lens
16081167|NCT02299869|Device|Cinza (Competitor-control)|contact lens
16081168|NCT02299869|Device|Grey (CVI-test)|contact lens
16081169|NCT02299869|Device|Esmeralda (Competitor-control)|contact lens
16081170|NCT02299869|Device|Jade (CVI-test)|contact lens
16081171|NCT02299869|Device|Azul (Competitor-control)|contact lens
16081172|NCT02299869|Device|Blue (CVI-test)|contact lens
16081173|NCT02299856|Other|Cardiac magnetic resonance scan|
16081174|NCT02299843|Procedure|RALPPS|Using radiofrequency ablation assisted ALPPS（RALPPS）instead of in-situ split of liver to form a coagulation band in stage I.Habib 4X was used in RFA.
16081175|NCT02299843|Procedure|ALPPS|Treat the hepatocellular carcinoma with ALPPS.
16081176|NCT02299830|Procedure|cryotherapy|use cryotherapy to delete soft neoplasm tissue in the airway
16081177|NCT02299830|Procedure|argon plasma coagulation|use argon plasma coagulation to delete hard neoplasm tissue in the airway
16081178|NCT02299830|Procedure|stent placement|use stent placement to open the airway compressed by out neoplasm
16081179|NCT02299830|Procedure|deletion tumor tissue by snare|use snare to delete polypoid neoplasm tissue in the airway
16081180|NCT02299817|Drug|Denosumab|"Prolia is used to treat osteoporosis (a disease that makes bones fragile) in women who have been through the menopause and in men who have an increased risk of fracture (broken bones). In women who have been through the menopause Prolia reduces the risk of fractures in the spine and elsewhere in the body, including in the hip.
~Prolia is also used to treat bone loss in men receiving treatment for prostate cancer that increases their risk of fracture. Prolia reduces the risk of fractures in the spine.
~Recently denosumab was found to be effective in preventing osteoporosis related fractures in post-menopausal women by blocking RANKL and thereby inhibiting the development and activity of osteoclast."
16081181|NCT02299817|Drug|Placebo|Placebo
16081182|NCT02299804|Drug|Levophencynonate Hydrochloric|this drug is M receptor inhibitor
16081183|NCT02299804|Drug|Placebo|No active ingredient
16081184|NCT02299791|Other|ALL|"This clinic-level intervention involves a toolkit of decision support tools. These tools are listed below.
~EHR tools to expedite identification
~a. EHR automated point-of-care alerts (Best Practice Alerts)
~EHR tools to expedite prescribing
~EHR order sets
~EHR text shortcuts for notation
~patient education materials (handout, poster)
~EHR-based outreach support tools a. EHR registries"
16081185|NCT02299791|Other|ALL|These clinics got the same exact intervention, but one year later, as this was a staggered randomized trial.
16081186|NCT02299778|Dietary Supplement|13C6-p-aminobenzoic acid|
16081187|NCT02299765|Drug|Gefitinib|patients in arm A will be given gefitinib as target therapy
16081188|NCT02299765|Drug|gemcitabine|patients in arm A will be given gemcitabine chemotherapy
16081189|NCT02299765|Drug|carboplatin|patients in arm A will be given carboplatin chemotherapy
16081190|NCT02299752|Procedure|single-gloving system|single-gloving system was used during Catheterization
16081191|NCT02299752|Procedure|double-gloving system|double-gloving system was used during Catheterization. inner and outer gloves were the same size
16081566|NCT02296775|Biological|Rituxan|Two 1000 mg intravenous infusions, one each on Day 1 and Day 15
16081192|NCT02299739|Drug|Herbal medicine|Herbal medicine was taken 3 times daily in dried powder (2g) and water-base decoction form (120ml) (Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes bidentata, Psoralea corylifolia, Peucedanum japonicum, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, and Atractylodes japonica).
16081193|NCT02299739|Procedure|Acupuncture|Acupuncture treatment was administered 1-2 times daily using mainly Ah-shi points and local acupuncture points.
16081194|NCT02299739|Procedure|Pharmacopuncture|Select ingredients similar to those included in the oral herbal medicine (Ostericum koreanum, Eucommia ulmoides, Acanthopanax Sessiliflorus, Achyranthes bidentata, Psoralea corylifolia, Peucedanum japonicum, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, and Atractylodes japonica) were freeze dried into powder form after decoction, then diluted in normal saline and adjusted for acidity and pH to be used in injections. The pharmacopuncture injections were injected once daily to the amount of 1 cc and Ah-shi points and local acupuncture points (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
16081195|NCT02299739|Procedure|Bee venom pharmacopuncture|Bee venom pharmacopuncture was applied after confirming a negative reaction to the hypersensitivity skin test. Diluted bee venom (saline:bee venom ratio, 10,000:1) was injected at 4-5 acupoints at the physician's discretion. Each acupuncture point was injected with approximately 0.2 cc to a total of 0.5-1 cc using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
16081196|NCT02299739|Procedure|Chuna manipulation|Chuna was administered 3-5 times a week. Chuna is a Korean version of spinal manipulation that incorporates conventional spinal manipulation techniques for mobilization involving high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement.
16081197|NCT02299726|Drug|Spironolactone|
16081198|NCT02299726|Other|Placebo|Matching placebo
16081199|NCT02299713|Device|Electroacupuncture|Electro acupuncture is a relatively new method of treatment in Chinese Medicine. Just as in a regular acupuncture treatment, needles are inserted into acupuncture points but small crocodile clips are then attached to the ends of needles to connect them to an electro-acupuncture device. In traditional acupuncture the inserted needles are manually vibrated to induce a response whilst in electro-acupuncture the bi-phasic current results in a constant (controlled) vibration of the needles and a direct electrical stimulation. The device allows the practitioner to adjust the frequency and intensity of the electric stimulation in a consistent manner which is not operator dependant.
16081200|NCT02299700|Other|No Intervention|The usability of the Janssen Autism Knowledge Engine (JAKE) as a system to monitor clinical outcomes in Autism Spectrum Disorder (ASD) will be observed.
16081201|NCT02299687|Drug|Omeprazole|
16081202|NCT02299674|Other|Level overground ambulation|
16081203|NCT02299661|Drug|DS-1093a|DS-1093a, single oral doses up to 50 mg
16081204|NCT02299648|Other|Molecular profiling|molecular profiling, patient derived cells, fresh or FFPE
16081205|NCT02299635|Drug|PF-03084014|Tablet, 10 mg, twice a day.
16081206|NCT02299635|Drug|PF-03084014|Tablet, 50 mg, twice a day
16081207|NCT02299635|Drug|PF-03084014|Tablet, 100 mg, twice a day
16081208|NCT02299622|Genetic|Genetic test|Next-generation sequencing (AmpliSeq) & fusion analysis
16081209|NCT02299609|Other|Ultrasound beams Philips HD11 XE®|Ultrasound beams used during standard echocardiography
16081210|NCT02299596|Other|Physical activity|The intervention will take place both pre- and postoperatively. During the hospital stay both groups will be treated in the same manner.
16081211|NCT02299583|Other|Preventive intervention trauma-informed early intervention|Every department appoints 2-4 health care professionals as child welfare officers (CWOs) who will be responsible for carrying out the intervention at the department. Whenever a child or adolescent is present in the department a CWO will be send for. The intervention consists of four distinct elements: 1) A standardized plan of action for the appointed health care CWOs on how to conduct trauma-informed health care for children and their families shortly after exposure to a PTE, 2) a training program for CWOs on trauma-informed support and communication with children and their families, 3) a supervision program for the CWOs, and 4) three psychoeducational booklets for young children, older children, and parents. The booklets will be given to the families by the CWOs.
16081212|NCT02299570|Biological|RBX2660 (microbiota suspension)|A suspension of intestinal microbes
16081213|NCT02299570|Other|Placebo|A suspension of saline and cryoprotectant
16081214|NCT02299557|Drug|Oxymetazoline gel|Oxymetazoline gel applied intra-anally once daily
16081215|NCT02299557|Drug|Placebo gel|Placebo gel applied intra-anally once daily
16081216|NCT02299544|Device|BlueWind Medical system|The BlueWind Medical System is intended for the treatment of patients with overactive bladder (OAB) including urinary urgency frequency and urge incontinence.
16081217|NCT02299531|Other|Varying meal energy density and portion size|
16081218|NCT02299518|Drug|mitoxantrone hydrochloride|Given IV
16081219|NCT02299518|Drug|etoposide|Given IV and PO
16081220|NCT02299518|Drug|cytarabine|Given IV
16081221|NCT02299518|Drug|selinexor|Given PO
16081222|NCT02299518|Other|laboratory biomarker analysis|Correlative studies
16081223|NCT02299518|Other|pharmacological study|Correlative studies
16081224|NCT02299505|Drug|ceritinib|The investigational drug ceritinib was supplied to the Investigators as 150 mg capsules, for oral administration.
16081225|NCT02299492|Other|Person Centered Care Planning|PCCP is a manualized provider-based intervention that maximizes consumer choice for adults receiving mental health services. PCCP focuses on engagement and individualized care, thereby enhancing the impact of existing evidence based practices.
16081226|NCT02299479|Device|Dexcom G4 Platinum CGM|Blood glucose levels will be monitored using continuous glucose monitors (CGMs). Participants will be asked to verify CGM low blood sugars using their home glucometer. Insulin dose adjustments will be made if there is concern that nocturnal hypoglycemia is occurring in relation to high daytime activity.
16081227|NCT02299479|Device|Activity monitor|Participants will be asked to wear an activity monitor so that we may assess their daily activity level. Insulin dose adjustments will be made if there is concern that nocturnal hypoglycemia is occurring in relation to high daytime activity.
16081228|NCT02299453|Behavioral|IPT|Nine sessions of telephone-administered interpersonal psychotherapy (IPT)
16082319|NCT02291536|Drug|tetrahydrocannabinol|
16081229|NCT02299440|Other|Baseline evaluation|Before perfusions begin, each patient will have a baseline evaluation including the following: the Columbia Suicide Severity Rating Scale (CSSRS), the Beck Scale for Suicide Ideation (BSSI), a physical pain VAS (visual analog scale), a mental pain VAS, the Clinical Global Impressions Scale (CGI-S), Beck's Hopeless scale (BHS), the Inventory of Depressive Symptomatology for the Clinician (IDS-C30), the Patient Rated Inventory of Side Effects (PRISE), the Young Mania Rating Scale (YMRS) and the Brief Psychiatric Rating Scale (BPRS).
16081230|NCT02299440|Drug|1st perfusion of ketamine|A 1st perfusion of ketamine is performed: 0.5 mg/kg diluted in saline, administered over 40 minutes by intravenous (IV) pump and cardiorespiratory monitoring. (Day 0)
16081231|NCT02299440|Drug|1st perfusion of saline|A 1st perfusion of saline is performed: the same volume of saline as in the ketamine arm, administered over 40 minutes by IV pump and cardiorespiratory monitoring. (Day 0)
16081232|NCT02299440|Other|Follow-up between perfusions|Patients will be re-evaluated with a selection of questionnaires at 40 minutes, 120 minutes, 4 hours, and 24 hours after the end of the first perfusion, and then again at 48 hours after the end of the first perfusion and right before the second perfusion and then again Day 3, Day 4, Week 2, Week 4 and Week 6.
16081233|NCT02299440|Drug|2nd perfusion of ketamine|A 2nd perfusion of ketamine is performed: 0.5 mg/kg diluted in saline, administered over 40 minutes by intravenous (IV) pump and cardiorespiratory monitoring. (Day 2)
16081234|NCT02299440|Drug|2nd perfusion of saline|A 2nd perfusion of saline is performed: the same volume of saline as in the ketamine arm, administered over 40 minutes by IV pump and cardiorespiratory monitoring. (Day 2)
16081235|NCT02299427|Behavioral|dog safety|use of dog safety website at home for about 2 weeks
16081236|NCT02299427|Behavioral|transportation safety|use of transportation safety website at home for about 2 weeks
16081237|NCT02299414|Drug|Anti-hypertensive therapy|1st line anti-hypertensive (Labetalol or Nifedipine ER) started; escalate to maximum dose and a preferred 2nd line medication if needed (nifedipine ER or Labetalol)
16081238|NCT02299414|Other|No anti-hypertensive therapy (unless BP is severe)|Treatment will not be started if blood pressure remains <160/105; for blood pressure ≥160/105, treatment with labetalol or Nifedipine ER will be initiated and maintained at lowest dose needed to keep blood pressure under 160/105.
16081239|NCT02299401|Drug|Misoprostol|Women will receive three 800 mcg doses of misoprostol.
16081240|NCT02299401|Device|Semi-quantitative pregnancy test|All women will be given a semi-quantitative pregnancy test (SQPT) for at-home follow-up.
16081241|NCT02299388|Drug|Liraglutide or Placebo|All subjects will be advised a low sodium diet. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval.
16081242|NCT02299375|Drug|Losmapimod tablets|Losmapimod tablets will be provided as 15 mg strength in a formulation containing lactose. Administered orally, twice daily approximately 12 hours apart and with food and water for the duration of the treatment period. Participants will be instructed to take their medication with a full glass of water twice-daily within 30 minutes after meals for the duration of their treatment period.
16081243|NCT02299375|Drug|Placebo tablets|Placebo tablets will be provided in a formulation containing lactose and visually matching the losmapimod tablets. Administered orally, twice daily approximately 12 hours apart and with food and water for the duration of the treatment period. Participants will be instructed to take their medication with a full glass of water twice-daily within 30 minutes after meals for the duration of their treatment period
16081244|NCT02299375|Drug|Salbutamol MDI|Salbutamol MDI will be provided as a rescue medication.
16081245|NCT02299349|Drug|bupivacaine liposome suspension|bupivacaine liposome suspension periarticular injection
16081246|NCT02299349|Drug|concentrated multi drug Ketorlac, Morphine PF, Epinephrine, Ropivicaine, 0.9% NaCL|Ketorolac 30 mg, Morphine PF 5 mg, Epinephrine 0.6 mg, Ropivacaine 400 mg, QS to 100ml with 0.9% NaCl
16081247|NCT02299336|Drug|Aflibercept|pro re nata (PRN)
16081248|NCT02299336|Procedure|Focal Laser|Focal laser administered based on pre-specified criteria
16081249|NCT02299323|Device|INDEPENDENCE|Lumbar Integrated plate and spacer, with percutaneous screws and rods.
16081250|NCT02299310|Drug|Valsartan|Valsartan 80mg/tablet, 1 tablet once daily (crossover)
16081251|NCT02299310|Drug|Perindopril|Perindopril 4mg/tablet, 1 tablet once daily (crossover)
16081252|NCT02299297|Drug|Tofacitinib|Dosage/Frequency: 5mg - 10mg, oral, twice daily
16081253|NCT02299284|Other|Intensive Home-based Bimanual and Lower-limb Training in Young Children With Hemiplegia|
16081254|NCT02299271|Drug|Ropivacaine|0.375% ropivacaine as a one-time, 60 milliliter injection
16081255|NCT02299271|Drug|Saline|Saline as a one-time, 60 milliliter injection.
16081256|NCT02299258|Device|Standard stents MTN-CG-s-20/100|The ends of the stents were semi-spherical with diameters of 28 mm and length of 20 mm. The length of the stents was 100 mm
16081257|NCT02299258|Device|Tailored stents MTN-WE-20/100-A|cup-shaped or funnel-shaped, according to the shapes of the proximal GOOs.
16081258|NCT02299245|Drug|rosuvastatin|different dose of rosuvastatin treatment
16081259|NCT02299232|Drug|Dexmedetomidine|Drug: dexmedetomidine 100 mcg/mL was applied in 3 mcg/kg and 4 mcg/kg doses in 1 mL preperates, 0.5 mL for each nostril
16081260|NCT02299219|Behavioral|Taking Charge: Managing Cancer Online|"n addition to standard medical care, adolescents in the experimental group will receive the Taking Charge: Managing Cancer Online Internet self-management program. The intervention is a 12-module interactive multi-component treatment protocol that consists of Cancer-specific education, self-management strategies, and social support that is available in English and French."
16081261|NCT02299219|Behavioral|Standard Medical Care and Cancer Resource Center|"The control group is designed to control for the potential effects on outcomes of time, attention and computer use during the intervention. In addition to standard medical care, adolescents in the attention control group will be provided with access to a self-guided patient education study website, which will have two components: basic patient educational materials about Cancer (Cancer Resource Centre) and online assessments."
16081332|NCT02298426|Behavioral|Health Management|We provide large scales of weight management information included recipes according to people's constitution. Information is provide through both face to face meeting and telephones. Materials are also given to participants.
16082320|NCT02291536|Drug|cannabidiol|
16081262|NCT02299206|Drug|CeraVe Baby Diaper Rash Cream|Parents/caregivers of subjects will administer CeraVe Baby Diaper Rash Cream (ingredients: Zinc oxide 10mg in 1g (1%) and dimethicone 10mg in 1g) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period.
16081263|NCT02299206|Drug|Desitin Maximum Strength Original Paste|Parents/caregivers of subjects will administer Desitin Maximum Strength Original Paste (ingredients: Zinc Oxide 40%) with each diaper change throughout the course of the study period. The product can be applied liberally as needed. Diapers and skin cleansing interventions will stay constant throughout the treatment period.
16081264|NCT02299193|Behavioral|Cognitive Behavioral Therapy|6 weekly, 20 minute online sessions about how thoughts and behaviors can affect sleep
16081265|NCT02299193|Behavioral|Healthy Sleep Habits|6 weekly, 20 minute online sessions about healthy sleep practices
16081266|NCT02299180|Behavioral|ACP|
16081267|NCT02299167|Drug|Dixon's up-and-down method|using a modified Dixon's up-and-down method (using 0.5 mg as a step size) (16). The first patient was tested at a dose 1.5 mg bupivacaine, if patient responded with failed block then the next patient received an increment of 0.5mg bupivacaine, if patient responded with successful block, then the next patient received a decrement of 0.5mg bupivacaine. The research continued until we obtained seven crossover midpoints.
16081268|NCT02299154|Behavioral|Psychological questionnaires|Psychological questionnaires about memory problems perceptions, anxiety, depression, quality of life and coping
16081269|NCT02299141|Drug|Nintedanib|
16081270|NCT02299128|Other|Physical Therapy Treatment|
16081271|NCT02299115|Drug|Prednisolone|Corticosteroid
16081272|NCT02299115|Drug|Vigabatrin|Antiepileptic
16081273|NCT02299102|Device|Jamshidi Manual Standard Device|Jamshidi Manual Standard Device
16081274|NCT02299102|Device|OnControl Powered Ported Device|OnControl Powered Ported Device
16081275|NCT02299089|Drug|octreotide FluidCrystal® injection depot|
16081276|NCT02299076|Behavioral|Behavioral economics incentives|Behavioral economics-informed incentives to promote engagement and outcomes in a smoking cessation intervention.
16081277|NCT02299076|Other|Minimal incentives|Minimal financial incentives to promote engagement and outcomes in a smoking cessation intervention.
16081278|NCT02299063|Drug|Dexmedetomidine|A bolus dose of 0.5 mcg/kg infused over 10 minutes will be administered, followed by a continuous infusion for the duration of the surgery at 0.6 mcg/kg/hr.
16081279|NCT02299063|Drug|0.9% NaCl|
16081280|NCT02299050|Drug|Cycloset|Bromocriptine QR 0.8 mg tablet 0.8 mg/day with dose increased to a maximum of 3.2 mg/day or as tolerated to a minimum of 2.4 mg/day Other names: Cycloset, B-QR
16081281|NCT02299024|Behavioral|Additional Opioid Information|Patients receiving this intervention are given additional information about the opioid pain medication that they are receiving in the form of a one page handout. The hand out was written in a health-literacy appropriate manner. A research assistant read the handout to them out loud, and they were given a copy to take home with them.
16081282|NCT02299011|Device|Orsiro drug eluting stent|Orsiro Hybrid drug eluting stent
16081283|NCT02299011|Drug|Biomatrix drug eluting stent|Biomatrix Flex drug eluting stent
16081284|NCT02298998|Other|Intervention|Patients randomized into the intervention group will follow the European Urologic Association (EAU) surveillance guidelines for cystoscopy follow-ups during bladder cancer surveillance.
16081285|NCT02298998|Other|Control|Patients randomized into the control group will follow the American Urologic Association (AUA) surveillance guidelines using cystoscopy ever 3 months for the first two years, and then every 6 months for 2 years.
16081286|NCT02298985|Drug|Curcumin|3 g/day (3 capsules/day) for 6 months
16081287|NCT02298985|Drug|placebo|3 g/day (3 capsules/day) for 6 months
16081288|NCT02298972|Behavioral|Nurse support and selfmanagement intervention|
16081289|NCT02298959|Biological|Pembrolizumab|Given IV
16081290|NCT02298959|Biological|Ziv-Aflibercept|Given IV
16081291|NCT02298946|Drug|AMP-224|10mg/kg on day 1 then every 14 days for a total of 6 doses.
16081292|NCT02298946|Radiation|Stereotactic Body Radiation Therapy(SBRT)|Dose Level 1: 8Gy x 1 day. Dose Level 2: 8Gy x 3 days
16081293|NCT02298946|Drug|Cyclophosphamide|200mg/m(2) IV on day 0.
16081294|NCT02298933|Drug|Eculizumab|300 mg single-use vials
16081295|NCT02298920|Drug|AZD0914|Radiolabelled AZD0914 for study of absorption, disposition, metabolism, and excretion in healthy volunteers.
16081296|NCT02298868|Drug|Baclofen|
16081297|NCT02298855|Behavioral|Individualised follow-up|Patients allocated to gynaecological cancer nurse specialist at the end of primary treatment. Follow-up is negotiated to suit their individual situation. Type of contact is flexible, primarily by telephone although some women may opt for face-to-face appointments. Patients will be assessed using a holistic guide to identify signs of disease progression, symptoms warranting intervention, and psychological issues. The nurses delivering the intervention are expert in the management of ovarian cancer and will work to a model of health promoting interactions oriented towards improving self-efficacy. The nurses will provide information and support to assist patients to manage troublesome symptoms and live with psychological discomfort.
16081298|NCT02298842|Device|Platelets stored in InterSol|A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. Following each blood collection, Platelet Additive Solution (PAS), InterSol, will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
16081333|NCT02298426|Behavioral|General Management|We provide general information about health. Information is provided through telephones and materials.
16081334|NCT02298426|Other|Placebo|We use placebo to replace the health product.
16081371|NCT02298205|Other|Asthma controller medication (Beclomethasone) adjustment strategy|The participant will adjust the dose of Beclomethasone based on symptoms
16081372|NCT02298205|Other|Provider-based adjustment|The provider will adjust the dose of Beclomethasone based on the participant's asthma control at their encounter with them
16081299|NCT02298842|Device|Platelets stored in Plasma|A platelet apheresis procedure involves connecting the blood in the donor's vein through tubing to a machine that separates the blood components. After the separation, the desired component of the blood is removed (platelets and plasma), while the remainder of the blood components are reinfused back into the patient. To prevent clotting, an anticoagulant (ACDA) is used throughout the procedure. During the collection, plasma collected from the donor will be added to the platelet product to prepare the final product for 7 day storage. The entire procedure is painless and should take 90 to 120 minutes and the subjects will have two collections within 6-8 days of each other.
16081300|NCT02298829|Drug|Subjects Previously Treated with AA4500|no treatment to be administered - observational only
16081301|NCT02298803|Device|Holter and Glucose monitoring|"(i) Continuous Glucose Monitoring A sterile disposable glucose-sensing sensor will be inserted into the subcutaneous tissues in either the abdomen or the upper outer quadrant of the patient's buttock. This sensor automatically measures the change in glucose in interstitial fluid every 5 minutes. The monitor will be worn for two days.
~(ii)Holter Monitoring The Holter monitor to capture cardiac conduction, specifically QT interval, will be worn for the same period as the continuous glucoe monitor with study participants encouraged to perform regular daily activities."
16081302|NCT02298790|Behavioral|Meal schedule|
16081303|NCT02298777|Procedure|- Skin biopsy - Urine sample - Blood sample|
16081304|NCT02298764|Other|Standard back pain treatment|Standard back pain treatment
16081305|NCT02298764|Other|Standard back pain treatment + 10 psychotherapeutic sessions|"Standard back pain treatment plus 10 psychotherapeutic session, that will include the shock-trauma method somatic experiencing."
16081307|NCT02298725|Other|DGA Diet Plan|A nutrient-adequate, balanced diet providing energy to maintain body weight, and macronutrient composition falling within the acceptable range, as recommended by the Institute of Medicine. The foods provided in this diet will be closely aligned with food group recommendations set in the 2010 Dietary Guidelines for Americans.
16081308|NCT02298725|Other|NHANES Diet Plan|"A nutrient-adequate, balanced diet providing energy to maintain body weight, and macronutrient composition falling within the acceptable range, as recommended by the Institute of Medicine. The foods provided in this diet will be closely aligned with the NHANES What we eat in America report."
16081309|NCT02298660|Drug|BOTOX|"BOTOX® Total dose per patient: 200U Number of cycles:1 cycle
~200 units of BOTOX® will be injected per procedure. BOTOX® will be diluted in 15mL saline to 20U/mL. BOTOX® injections will be performed with a normal 22 FF rigid cystoscopy or flexible 6Fr injection needle. BOTOX® will be injected into the detrusor muscle at 20 sites (10U per site), sparing the trigone. A local anaesthesia with instillation of 50 ml lidocaine 2% into the bladder will be done prior to the procedure to avoid autonomic dysreflexia."
16081310|NCT02298621|Other|pomegranate juice|Randomized clinical trial or RCT
16081311|NCT02298621|Other|placebo|Randomized clinical trial or RCT
16081312|NCT02298608|Device|Nano Knife|Percutaneous, CT guided, ablation of renal mass
16081313|NCT02298595|Drug|cisplatin|75 mg/m2 IV day 1 of each cycle
16081314|NCT02298595|Drug|Cetuximab|XXXX day 1, 8, and 15 of each cycle
16081315|NCT02298595|Drug|BYL719|200, 250, 300, or 350 mg/day by mouth every day
16081316|NCT02298582|Drug|intranasal fentanyl|During the two first sessions of care or rehabilitation, patients do not receive Pecfent® in order to assess their basal pain. During the following four sessions, patients will receive transmucosal fentanyl, 10 minutes before care. A titration of PecFent will be done at each session
16081317|NCT02298569|Behavioral|multi-pronged program to improve early postpartum discharge|"Better team integration and changes to promote interprofessional collaboration and communication between healthcare providers involved in pre- and post-natal care in a perinatal network.
~Transition optimization: all involved healthcare professionals will complete a specific form during pregnancy and hospitalization to coordinate support safe process, and to improve quality transitions to outpatient midwives and pediatrician. A check-list will be completed by the mother to assess whether she agrees to early discharge and that she is aware of its conditions Implementation of best practices about early discharge after delivery to improve safety of early discharge particularly for neonates at risk (jaundice and dehydration)."
16081318|NCT02298543|Other|coronary spasm|
16081319|NCT02298530|Other|Combination of caffeine and theanine|Beverage containing caffeine and theanine
16081320|NCT02298530|Other|Caffeine|Beverage containing caffeine
16081321|NCT02298517|Procedure|incentive spirometry|Incentive spirometry to flow and incentive spirometry to volume
16081322|NCT02298517|Procedure|inspiratory load equipment|Threshold and Power breathe
16081323|NCT02298504|Drug|Mineral Trioxide Aggregate|Vital pulp therapy
16081324|NCT02298504|Drug|Biodentin|Vital pulp therapy
16081325|NCT02298504|Device|Vitrebond|Vital pulp therapy
16081326|NCT02298491|Drug|H.P. Acthar Gel|80 IU subcutaneously daily for 10 days then followed by 80 IU subcutaneously three times per week through Month 12
16081327|NCT02298478|Behavioral|NO-FEAR Airlines|"NO-FEAR Airlines is a computer program that allows people who are afraid to fly to be exposed to images and sounds related to their phobic fears on a standard personal computer. The treatment can be totally self-applied.
~NO-FEAR Airlines divides the flight process into six sequential stages: (1) flight preparation, (2) a series of activities immediately prior to flying on the day of the flight, (3) boarding and taking off, (4) the central part of the flight, (5) the airplane's descent, approach to the runway and landing, (6) sequence with images and auditory stimuli related to plane crashes."
16081328|NCT02298465|Procedure|Supine ESWL|ESWL to distal ureteric stone is performed in the supine position with the shockwave generator placed in the patient's buttock area. The aim is to direct the shockwaves through the greater and lesser sciatic foramina to reach the distal ureter.
16081329|NCT02298465|Procedure|Prone ESWL|ESWL to the distal ureteric stone is performed in the traditional prone position. The shockwave generator is placed on the patient's abdomen
16081330|NCT02298465|Device|Extracorporeal Shockwave Lithotripsy (ESWL)|The ESWL machine we use is the Dornier S2 lithotriptor. ESWL is performed without any sedation or anesthesia under fluoroscopy. Painkillers are given upon request.
16081331|NCT02298452|Device|Hearing aid.|The hearing aid will be fitted to the individual hearing loss of the subject.
16081567|NCT02296775|Biological|MabThera|Two 1000 mg intravenous infusions, one each on Day 1 and Day 15
16081335|NCT02298426|Dietary Supplement|SCHSANDRA PLUS, YI RUI CAPSULE, Gest Aid Plus: INFINITUS®|We use dietary supplement products to help balance the constitution of participants. Each participant got one of the three dietary supplement products. SCHSANDRA PLUS, INFINITUS® is a health product made of Schisandra, ginseng, Ginseng, Radix and other plant materials which can help enhance the body's antioxidant capacity. YI RUI CAPSULE , INFINITUS® is a health product made of salvia, hawthorn, alisma, perilla oil microcapsules, panax powder, ginkgo biloba and other plant materials which can assist lower the blood lipid level. Gest Aid Plus, INFINITUS® is a health product made of yam, codonopsis, poria, white beans, dried tangerine peel and other plant materials which can help regulate intestinal flora.
16081336|NCT02298413|Device|PCI with Absorb scaffold|Implantation of biovascular scaffold during PCI
16081337|NCT02298400|Device|Acuvue® Oasys® Lenses (senofilcon A)|Contact lenses placed in each eye during the day for about 8 hours
16081338|NCT02298400|Device|30-Day Bausch + Lomb PureVision (balafilcon A)|Contact lenses placed in each eye during the day for about 8 hours
16081339|NCT02298400|Device|Clariti® 1-Day (Somofilcon A)|Contact lenses placed in each eye during the day for about 8 hours
16081340|NCT02298387|Drug|OMP-305B83|intravenous (in the vein) infusions
16081341|NCT02298374|Other|Homecare reablement|
16081342|NCT02298374|Other|usual care|
16081343|NCT02298361|Other|Health insurance outreach IT tools|"IT tools that support Community Health Centers in children's health insurance outreach efforts (insurance outreach IT tools), adapted from tools proven to support chronic disease management."
16081344|NCT02298348|Drug|Sorafenib|Sorafenib -100-200mg/m2/dose (dose escalation), Orally BID continuously Days 1 thru 28 Cyclophosphamide - 250 mg/m2/day IV x 5 days - day 1 thru day 5 Topotecan - 0.75 mg/m2/day IV x 5 days - day 1 thru day 5
16081345|NCT02298348|Drug|Cyclophosphamide|250mg/m2/day IV x5 days (Day 1 through Day 5 of each course)
16081346|NCT02298348|Drug|Topotecan|0.75mg/m2.day IV x5 days (Day 1 through Day 5 of each course)
16081347|NCT02298335|Drug|prednisone|Full-dose induction period: Prednisone 1mg/kg.day, maximum 60mg/day, orally, divided into 3 times; Protracted tapering period: orally, no ask for fract. dos.
16081348|NCT02298322|Device|CoolSculpting System|
16081349|NCT02298309|Other|Test-and-Treat TB|
16081350|NCT02298283|Drug|brentuximab vedotin|is 1.8 mg/kg administrated by IV infusion
16081351|NCT02298283|Drug|Cyclophosphamide|1250 mg/m², IV, part of the BEACOPP chemiotherapy, D1 of 2 BEACOPP cycles, every 3 weeks
16081352|NCT02298283|Drug|Adriamycin|35mg/m², IV, part of the BEACOPP chemiotherapy, D1 of 2 BEACOPP cycles, every 3 weeks
16081353|NCT02298283|Drug|Oncovin|1.4 mg/m², IV, part of the BEACOPP chemiotherapy, D8 of 2 BEACOPP cycles, every 3 weeks
16081354|NCT02298283|Drug|Bleomycin|10 mg/m², IV, part of the BEACOPP chemiotherapy, D8 of 2 BEACOPP cycles, every 3 weeks
16081355|NCT02298283|Drug|Etoposide|200 mg/m², IV, part of the BEACOPP chemiotherapy, D1 to D3 of 2 BEACOPP cycles, every 3 weeks
16081356|NCT02298283|Drug|Procarbazine|100 mg/m², IV, part of the BEACOPP chemiotherapy, D1 to D7 of 2 BEACOPP cycles, every 3 weeks
16081357|NCT02298283|Drug|Prednisone|40 mg/m², IV, part of the BEACOPP chemiotherapy, D1 to D7 of 2 BEACOPP cycles, every 3 weeks
16081358|NCT02298283|Drug|G-CSF|5 µg/kg/j, SC, D9 until GB 1.0x109/L
16081359|NCT02298283|Radiation|30 Grays|30 Gy radiation of sites initially diagnoses + 6Gy for residual sites, 3 to 4 weeks after D1 of BEACOPP cycle 2.
16081360|NCT02298270|Behavioral|The Relaxation Response Resiliency Program (3RP) via Skype|8-week group intervention, delivered via Skype, teaching relaxation and psychological resiliency enhancing skills. Topics include the relaxation response, meditation, and yoga.
16081361|NCT02298257|Drug|brentuximab vedotin|given IV
16081362|NCT02298257|Drug|Doxorubicin Hydrochloride|Given IV
16081363|NCT02298257|Drug|Vinblastine|Given IV
16081364|NCT02298257|Drug|Dacarbazine|Given IV
16081365|NCT02298244|Procedure|PV isolation + GP Ablation|In real time builds the 3D card LA using nonfluoroscopic navigation system.Left and right PVs encircle in 1 lesion line by circumferential PV isolation.Radiofrequency energy delivered at 43◦C,35 W,0.5 cm away from the PV ostia at the anterior wall,and reduced to 43◦C,30 W,1 cm away from the PV ostia at the posterior wall,with a saline irrigation speed of 17 ml/min.Each lesion of ablation continuously until the local potential amplitude decreased by >80% or RF energy deliveries exceeded 40 seconds.The endpoint of circumferential PV isolation is PV isolation;this confirm when Lasso mapping show the disappearance of all PV potentials or the dissociation of PV potentials from left atrial activity.To accomplish ganglionated plexi ablation,LA target sites were identified as the anatomic locations where vagal reflexes were evoked by transcatheter HFS.Rectangular electrical stimuli were delivered at a frequency of 50 Hz,output amplitude 15V and pulse duration of 10 ms,for 5 sec
16081366|NCT02298244|Procedure|PV isolation + GP ablation + Pulmonary GP ablation|"The procedure of AF ablation is the same like in the circumferential PV isolation + GP Ablation.
~8-Fr sheath is carried through the right heart into the pulmonary artery trunk. Using ablation electrode constructed 3D map of the pulmonary artery trunk and the right and left main branches. Further HFS performed with the tip ablation electrode at the bifurcation of the pulmonary artery and in the ostium of the left and right pulmonary arteries (less than 2 mm distal to the bifurcation) 20 Hz, duration of each stimulus 10 ms. A positive response would be considered an increase in the RR interval of more than 50% of baseline within 10 seconds. In areas with a positive response to HFS, will be performed RFA Efficiency criterion: no previously described responses to HFS in the ablation area. Parameters RFA: 8-10 watts for 60 seconds duration at one point, the irrigation speed of 5 ml / min."
16081367|NCT02298231|Other|Standard of Care Balance Intervention|Standard balance therapy as performed by a physical therapist
16081368|NCT02298231|Other|Mystic Isle Balance Intervention|Balance therapy using virtual reality
16081369|NCT02298231|Other|Mystic Isle Balance Intervention with Dual Task|Balance therapy using virtual reality and performing cognitive tasks
16081370|NCT02298218|Drug|Meloxicam|The intervention drug, meloxicam is safe medicine which is used to treat pain or inflammation caused by osteoarthritis or rheumatoid arthritis in adults and children who are at least 2 years old. It may also be used for purposes not listed in the medication guide. It will be taken once a daily with a dose of 0.125 mg/kg/day (high-dose group) or 0.06 mg/kg/day (low-dose group). After 6 months of medication, the maintenance will be decided by the comparison of liver stiffness score before and after the intervention.
16081373|NCT02298192|Drug|insulin degludec/liraglutide|For subcutaneous (s.c., under the skin) injection, once daily. Subjects will be instructed to continue with the same dose of OADs (metformin alone or in combination with pioglitazone), as prior to the trial.
16081374|NCT02298179|Biological|RSV F subunit 45 μg No adjuvant|2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
16081375|NCT02298179|Biological|RSV F subunit 45 μg Aluminum hydroxide adjuvant|2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
16081376|NCT02298179|Biological|RSV F subunit 45 μg MF59 adjuvant|2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
16081377|NCT02298179|Biological|RSV F subunit 90 μg No adjuvant|2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
16081378|NCT02298179|Biological|RSV F subunit 90 μg Aluminum hydroxide adjuvant|2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
16081379|NCT02298179|Biological|RSV F subunit 90 μg MF59 adjuvant|2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
16081380|NCT02298179|Biological|RSV F subunit 135 μg No adjuvant|2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
16081381|NCT02298179|Biological|RSV F subunit 135 μg Aluminum hydroxide adjuvant|2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
16081382|NCT02298179|Biological|RSV F subunit 135 μg MF59 adjuvant|2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
16081383|NCT02298179|Drug|Placebo|2 doses of 0.5 milliliters (mL) each of injectable solution administered intramuscularly, in the deltoid muscle, preferably in the non-dominant arm.
16081384|NCT02298166|Drug|chemotherapy (Mitoxantrone, Cytarabine)|"Induction therapy:
~Mitoxantrone 10 mg/m² IV, push (8 mg/m² for patients > 60 years of age and/or previous allogeneic HCT) d 1-3
~Cytarabine 1000 mg/m² IV (500 mg/m² for patients > 60 years of age and/or previous allogeneic HCT), over 3 hours, d 1-6
~Consolidation therapy:
~Younger adult patients (18 to 60 yrs):
~Cytarabine 1500 mg/m² by i.v infusion over 3 hours BID on days 1-3 (total dose 9000 mg/m²).
~Older patients (> 60 yrs) and or previous allogeneic HCT:
~Cytarabine 1000 mg/m² by i.v. infusion over 3 hours BID on days 1-3 (total dose 6000 mg/m²)."
16081385|NCT02298166|Drug|Placebo|"Induction therapy:
~Placebo to be given as p.o. TID starting d 7+, given continuously thereafter until 48 hours prior to the next chemotherapy.
~Consolidation therapy:
~Placebo will start on day 4, thereafter with continuous dosing until 48h before start of subsequent consolidation chemotherapy.
~Maintenance therapy with placebo is intended in all patients after allogeneic HCT or intermediate-dose cytarabine consolidation therapy. Maintenance therapy will be given for 364 days (equivalent to 13 cycles à 28 days) after recovery from allogeneic HCT or IDAC.
~Maintenance with placebo will be given at the same dose tolerated during induction therapy."
16081386|NCT02298166|Drug|Crenolanib|"Induction therapy:
~Crenolanib to be given as p.o. TID starting d 7+, given continuously until 48 hours prior to the next chemotherapy.
~Consolidation therapy:
~Crenolanib will start on day 4, thereafter with continuous dosing until 48h before start of subsequent consolidation chemotherapy.
~Maintenance therapy with Crenolanib is intended in all patients after allogeneic HCT or intermediate-dose cytarabine consolidation therapy. Maintenance therapy will be given for 364 days (equivalent to 13 cycles à 28 days) after recovery from allogeneic HCT or IDAC.
~Maintenance with Crenolanib will be given at the same dose tolerated during induction therapy."
16081387|NCT02298166|Other|Allogeneic stem cell transplantation|"In patients achieving a CR or CRi after salvage-reinduction chemotherapy allogeneic HCT from a matched related or unrelated donor is the preferred form of consolidation. Preferred source of allogeneic HSC are mobilized peripheral blood stem cells. Other forms of allogeneic transplantation (haploidentical donor; cord blood) are allowed.
~Allogeneic HCT should be conducted at the earliest time point after the start of the last chemotherapy but no later than after 56 days. A delay of transplant beyond this time window need to be discussed with the Coordinating Investigator. Patients can receive allogeneic HCT directly after salvage re-induction chemotherapy with MC, but also later on following consolidation with IDAC."
16081388|NCT02298153|Drug|atezolizumab|atezolizumab: administered intravenously (IV) every three weeks (q3w)
16081389|NCT02298153|Drug|epacadostat|epacadostat: Oral daily dosing
16081390|NCT02298140|Other|SMS reminders|Text-message reminders about malaria case management will be prepared and distributed to all health workers seeing outpatients in the selected health facilities through their personal mobile phones and facility phones. These messages will reflect ACT recommendations from Tanzania's national guidelines for the diagnosis and treatment of malaria and training manuals. The intervention will run for three months, two text message a day will be send to all identified health workers during regular working hours (i.e. between 8 am to 3 pm), three times a week. To avoid health worker's fatigue of receiving these messages, the messages will also contain some non-malaria humorous, inspirational, motivational and educative contents.
16081391|NCT02298127|Other|Auricular acupressure|For each auricular acupressure weekly session, magnetic ears tacks will be will be applied by certified traditional Chinese medicine practitioners according to the allocated group assignment, for a duration of one month.
16081392|NCT02298114|Device|NEUROMUSCULAR ELECTRICAL STIMULATION|Neuromuscular electrical stimulation will be applied Functional Electrical Stimulation (FES) machine.
16081393|NCT02298114|Other|Conventional physiotherapy|The control group will receive conventional physiotherapy associated the placebo electrical stimulation
16081394|NCT02298101|Drug|Technetium-99m - Diethylenetriaminepentaacetic acid|Solution placed on the nebulizer reservoir
16081395|NCT02298101|Device|Aeroneb Solo Adapter|Nebulizer
16081396|NCT02298101|Device|Opti-Mist Plus Nebulizer|Standard jet nebulizer
16081397|NCT02298101|Other|Planar scintigraphy|Imaging technique to investigate whole lung deposition
16081398|NCT02298101|Other|Single photon emission computed tomography|Imaging technique to investigate regional pulmonary deposition
16081399|NCT02298101|Other|Spirometry|FEV1, FVC assessment
16082321|NCT02291536|Other|placebo|
16081400|NCT02298088|Drug|Ticagrelor 180 mg|Ticagrelor, 180 mg as early as possible after the index event and not >24 h post event followed by 90 mg twice daily for 12 months.
16081401|NCT02298088|Drug|Clopidogrel|"300 mg clopidogrel as early as possible after the index event and not > 24h post event, followed by 75mg/day for 12 months.
~For patients with > 75 years the recommended load dose is 75 mg instead 300 mg."
16081402|NCT02298075|Drug|Eltrombopag|Investigation of the impact of TPO-RAs on the achievement of sustained and persistent response after discontinuation in adult patients affected by pITP.
16081403|NCT02298075|Drug|Romiplostin|Investigation of the impact of TPO-RAs on the achievement of sustained and persistent response after discontinuation in adult patients affected by pITP.
16081404|NCT02298062|Drug|Infliximab|The treatment-resistant children will be randomly assigned to either the infliximab or IVIG group in a 1:1 ratio and receive either infliximab (5 mg/kg at 1 mg/mL intravenously over 2 h) or IVIG (2g/kg). The primary outcome measure is change in absolute cell counts, concentrations of C-reactive protein, alanine transaminase,IL-1,IL-6,TNF-a,STNFR-I,STNFR-2; number of fever days (24 h period with a temperature of at least 38•0°C) from enrolment; duration and cost of hospital stay.The secondary 0utcome Measure is the incidence of coronary artery abnormalities
16081405|NCT02298062|Drug|IVIG|The treatment-resistant children will be randomly assigned to either the infliximab or IVIG group in a 1:1 ratio and receive either infliximab (5 mg/kg at 1 mg/mL intravenously over 2 h) or IVIG (2g/kg). The primary outcome measure is change in absolute cell counts, concentrations of C-reactive protein, alanine transaminase,IL-1,IL-6,TNF-a,STNFR-I,STNFR-2; number of fever days (24 h period with a temperature of at least 38•0°C) from enrolment; duration and cost of hospital stay.The secondary 0utcome Measure is the incidence of coronary artery abnormalities
16081406|NCT02298049|Other|Satiated / Pre-meal|All participants were scanned before and after not being fed (pre-meal), and before and after being given a satiating lunch (satiated).
16081407|NCT02298049|Device|MRI|
16081408|NCT02298036|Behavioral|(Remote) Cognitive Behaviour Therapy|Randomised controlled trial of 6-10 sessions of CBT for health anxiety delivered remotely via video calling or the telephone versus treatment as usual. Treatment as usual will be that decided by the patient with their general practitioner and other health providers they consult for unscheduled/urgent care.
16081412|NCT02298010|Drug|Capecitabine, oxaliplatin|
16081413|NCT02297997|Drug|cetylpyridinium chloride|Four study groups take cetylpyridinium chloride of 1.5mg, 3mg, 4.5mg and 6mg daily for two weeks.
16081414|NCT02297997|Drug|Placebo|Control group takes the placebo for the same period.
16081415|NCT02297945|Drug|metyrapone|Single arm study
16081416|NCT02297932|Behavioral|Strength training|Participants will engage in a home-based strength training program.
16081417|NCT02297932|Behavioral|Stretching|Participants will engage in a home-based stretching training program
16081418|NCT02297919|Behavioral|Effectiveness of Internet Based Obesity Control Programme|
16081419|NCT02297906|Drug|Ketorolac|Non-steroidal anti-inflammatory drug
16081420|NCT02297893|Behavioral|Dexterity training program (HOMEDEXT)|The dexterity training program contains 7 exercises which focus on improving fine motor skills.
16081421|NCT02297893|Behavioral|Theraband training program|The Theraband training program contains 7 exercises which focus on improving upper limb strength
16081422|NCT02297880|Other|Beverage containing low calorie sweeteners|Beverage containing low calorie sweeteners
16081423|NCT02297880|Other|Still water|Still water (no flavour)
16081424|NCT02297867|Drug|ADSCs|autologous ADSCs
16081425|NCT02297854|Drug|Valganciclovir Hydrochloride|Valganciclovir Hydrochloride Tablets 450 mg
16081426|NCT02297841|Device|Experimental: Novel lubricant Miami Fragrance|
16081427|NCT02297841|Device|Experimental: Novel lubricant Miami no Fragrance|
16081428|NCT02297841|Device|KY Liquid lubricant|
16081429|NCT02297841|Device|Astroglide Gel lubricant|
16081430|NCT02297828|Device|Boussignac CPAP|Boussignac CPAP with a 50% FiO2 (adjusted in a piece adapted to the system) and a pressure of 5cmH2O (measured with a manometer) is applied immediately after extubation and mantained for two hours after extubation in the post anesthesia care unit (PACU).
16081431|NCT02297828|Device|Venturi face mask|Venturi mask with a 50% FiO2 is used immediately after extubation and mantained for two hours in the post anesthesia care unit (PACU).
16081432|NCT02297815|Drug|Broad-spectrum antibiotics|Amoxicillin-clavulanate, azithromycin, cefdinir, cefprozil, cefuroxime axetil, cefadroxil, cephalexin
16081433|NCT02297815|Drug|Narrow-spectrum antibiotics|Amoxicillin, Penicillin
16081434|NCT02297802|Drug|PD-0325901|
16081435|NCT02297789|Device|Investigative Full Face Mask with Headgear|
16081436|NCT02297763|Drug|quetiapine|"patient body weight <50kg : quetiapine 12.5mg patient body weight >=50kg : quetiapine 25mg
~quetiapine 12.5mg (bwt <50kg ) or 25mg (bwt>= 50kg) study medicine is pulverized to power and melted in 10cc tepid water. The study medicine(quetiapine) will be provided as liquid form.
~The study medicine(quetiapine) was provided as liquid form (medicine was pulverized and melted in 10cc water)."
16081437|NCT02297763|Drug|placebo|The placebo is made of 100mg of corn starch which is melted in 10cc water.
16081438|NCT02297750|Procedure|double-wire technique in patients undergoing ERCP with biliary cannulation|
16081439|NCT02297750|Procedure|single-wire technique in patients undergoing ERCP with biliary cannulation|
16081440|NCT02297737|Behavioral|Tai Chi|
16081441|NCT02297737|Other|Health Education|
16081442|NCT02297724|Other|Oxygen|Administration of oxygen will last for no more than 10 min, with flow rate 15L/min via non-rebreather facial mask. Each subject will have once of the administration per scan.
16081476|NCT02297464|Other|Eggs - 2 per day for breakfast|11-week crossover study in which participants consumed 2 eggs or 1 packet of oatmeal per day daily for 4 weeks, separated by a 3-week washout period.
16081568|NCT02296762|Drug|Sirolimus|Sirolimus tablets 2 mg
16081443|NCT02297711|Procedure|Total ExtraPeritoneal|This is a keyhole operation which will use one small incision at the 'belly button' followed by two small incisions of approximately 5mm in diameter below the 'belly button' . A lightweight mesh is then placed over the inguinal ligament to reinforce the weakness. This approach is keyhole in nature with visualisation of the inguinal canal from behind - posteriorly.
16081444|NCT02297711|Procedure|Open minimal suture repair|This is best described as open minimal repair and involves a small incision into the groin of the affected side. Once the inguinal canal is exposed the back wall is repaired using a simple suture to reinforce the weakness. This approach is open surgery in nature with visualisation of the inguinal canal from in front - anteriorly.
16081445|NCT02297698|Biological|NeuVax vaccine|At the time of vaccine administration, a frozen solution of E75 acetate (1.5 mg/mL) is thawed and 1000mcg E75 peptide mixed thoroughly with 250mcg GM-CSF. This constitutes the NeuVax vaccine. Patients randomized to this arm will receive vaccinations of nelipepimut-S/GM-CSF administered intradermally every three weeks for six total vaccinations, 30-120 minutes after completion of trastuzumab infusion. The first vaccination will be given with the third dose of maintenance trastuzumab administered as monotherapy optimally, but may be given with later maintenance doses of trastuzumab, provided there are at least six remaining doses of trastuzumab to overlap with the primary vaccine series.
16081446|NCT02297698|Drug|Trastuzumab|Herceptin will be administered to patients every three weeks as monotherapy for one year, to be given upon completion of standard of care chemotherapy/radiotherapy. The first trastuzumab infusion will be given no sooner than three weeks and no later than 12 weeks after completion of chemotherapy/radiotherapy. Trastuzumab will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk.
16081447|NCT02297698|Drug|GM-CSF|For patients randomized to the GM-CSF alone arm, they will receive inoculations of GM-CSF (250mcg) administered intradermally every three weeks for six total vaccinations, 30-120 minutes after completion of trastuzumab infusion. The first injection will be given with the third dose of maintenance trastuzumab administered as monotherapy optimally, but may be given with later maintenance doses of trastuzumab, provided there are at least six remaining doses of trastuzumab to overlap with the primary vaccine series.
16081448|NCT02297685|Device|Sham Transcutaneous nerve stimulation|The group with sham transcutaneous nerve stimulation (TENS) did not receive any electrical treatment. We placed 4 surface electrodes (5x5 cm Prim-Trode, Spain) over the L1 and L5 transverse processes with respect to the spine but we did not delivery any current. The patients were informed that they may or may not feel any sensation at the application site of the electrodes.
16081449|NCT02297685|Device|Transcutaneous nerve stimulation|The group with transcutaneous nerve stimulation (TENS) received electrical stimulation for 12 sessions at a frequency of 80 Hz and with a pulse width of 150 ns. The TENS was delivered by using 4 surface electrodes (5x5 cm Prim-Trode, Spain) placed over the L1 and L5 transverse processes with respect to the spine. The current intensity was set 3 times during each session according to each patient's sensitivity.
16081450|NCT02297685|Device|Interferential currents|The group with IC received a base frequency of 4000 Hz with AMF = 65 Hz, sweep = 95 Hz and slope of 1/1 in tetrapolar mode (Endomed 492 Enraf-nonius, Netherlands). The current was applied by using 4 surface electrodes (5x5 cm Prim-Trode, Spain) into two channels: were symmetrically placed over the L1 and L5 transverse processes with respect to the spine; the current intensity was set 3 times during each session according to each patient's sensitivity.
16081451|NCT02297672|Radiation|Stranded palladium seed interstitial implant|Interstitial implantation of stranded palladium 103 seeds in seroma with a margin
16081452|NCT02297672|Device|3 dimensional breast ultrasound|guidance of placement of interstitial needles in breast
16081453|NCT02297672|Device|Computerized tomography (CT)|Breast CT for planning and assessing interstitial implantation of radioactive seeds
16081454|NCT02297659|Procedure|Primary Fascial Closure|Abdominal wall closure following damage control laparotomy.
16081455|NCT02297659|Device|wound vac dressing application|temporary abdominal wall closure with this device after damage control laparotomy
16081456|NCT02297646|Behavioral|Endurance Training|
16081457|NCT02297620|Drug|Suglat®|oral
16081458|NCT02297607|Dietary Supplement|Tube Feeding|
16081459|NCT02297594|Drug|AK0529|AK0529 capsule for oral administration
16081460|NCT02297594|Drug|Placebo|Sugar placebo capsule for oral administration
16081461|NCT02297568|Drug|Calciferol|Comparison 25OHD levels between calciferol and placebo
16081462|NCT02297568|Drug|placebo|
16081463|NCT02297555|Device|ENDOBARRIER®|This medical device consists of a tube (impermeable fluoropolymer) inserted endoscopically and secured by hooks in the wall of the duodenal bulb. From the anchor site, this duodeno-jejunal sheath covers 60 cm in the small intestine. It thus limits the contact of nutrients with digestive juices (bile and pancreatic juice) and initial absorption, at least in part mimicking duodenal exclusion of the gastric bypass, one of the techniques of bariatric surgery.
16081464|NCT02297542|Biological|Flu Vaccine|
16081465|NCT02297529|Drug|Talimogene Laherparepvec|Open label single arm study. The initial dose of talimogene laherparepvec is up to 4.0 mL of 106 PFU/mL. Subsequent doses of talimogene laherparepvec are up to 4.0 mL of 108 PFU/mL.
16081466|NCT02297516|Drug|Azzalure or Dysport|Glabellar lines
16081467|NCT02297516|Device|Restylane or Emervel filler|Facial tissue augmentation
16081468|NCT02297516|Device|Restylane Skinbooster|Facial skin rejuvenation
16081469|NCT02297503|Drug|Azzalure|Glabellar lines
16081470|NCT02297503|Device|Restylane/Emervel filler|Facial tissue augmentation
16081471|NCT02297503|Device|Restylane Skinbooster|Facial skin rejuvenation
16081472|NCT02297490|Drug|Placebo|Placebo treatment is identical to the active treatment schedule. The placebo-preparation used is identical to the active solution but without any allergen substance in it.
16081473|NCT02297490|Biological|Allergovit 6-grasses|Immunotherapy will be performed for approx. 5 months. 7 injections will be administered at weekly intervals to reach the maintenance dose. However, dosing must be individualised.
16081474|NCT02297477|Drug|atovaquone-proguanil|A daily fixed dose combination of 4 tablets containing atovaquone 250mg and proguanil hydrochloride 100mg (total 1000mg/400mg respectively)
16081475|NCT02297477|Drug|artesunate-atovaquone-proguanil|A daily fixed dose combination of 4 tablets containing atovaquone 250mg and proguanil hydrochloride 100mg (total 1000mg/400mg daily respectively) in addition to 4 tablets containing 50mg artesunate (200mg daily)
16081477|NCT02297464|Other|1 packet of oatmeal per day|11-week crossover study in which participants consumed 2 eggs or 1 packet of oatmeal per day daily for 4 weeks, separated by a 3-week washout period.
16081478|NCT02297451|Procedure|Proximal radial/ulnar artery as inflow|Proximal radial/ulnar artery used as inflow
16081479|NCT02297438|Drug|Palbociclib|Palbociclib, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
16081480|NCT02297438|Drug|Letrozole|Letrozole, 2.5mg, orally once daily (continuously)
16081481|NCT02297438|Drug|Placebo|Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
16081482|NCT02297438|Drug|Letrozole|Letrozole, 2.5mg, orally once daily (continuously)
16081483|NCT02297425|Drug|PF-06459988|The study will evaluate PF-06459988 PO (tablets) continuous daily dosing in 21 day cycles. The starting dose for PF-06459988 will be 50 mg PO daily. The escalation/de-escalation rules will follow the modified toxicity probability interval method with adjustments using the DLT rate and maximum size per dose level of 10 patients
16081484|NCT02297412|Drug|Minocycline Hydrochloride|Given PO
16081485|NCT02297412|Other|Placebo|Given PO
16081486|NCT02297412|Other|Quality-of-Life Assessment|Ancillary studies
16081487|NCT02297412|Other|Questionnaire Administration|Ancillary studies
16081488|NCT02297399|Drug|PEG-ascorbate 2L|"Subjects will be asked to proceed to colonic cleansing with the interventional agents as per summary of product characteristics and specific instructions from members of the research team.
~Participants will be required to be on a low residue diet for 4 days before the procedure. The preparation will begin at 9:00 pm on the evening before the colonoscopy is scheduled. Participants will take 2 sachets (labelled A and B) of the investigational product and take their contents diluted in 1 liter of water. Two other sachets, also labelled A and B, will be taken diluted in 1 liter of water 4 to 5 hours before the procedure. Fasting will be required from 2 hours after the investigational product has been taken."
16081489|NCT02297399|Drug|PEG 4L|"Subjects will be asked to proceed to colonic cleansing with the interventional agents as per summary of product characteristics and specific instructions from members of the research team.
~Participants will be required to be on a low residue diet for 4 days before the procedure. The preparation will begin at 9:00 pm on the evening before the colonoscopy is scheduled. Participants will take 8 sachets of the investigational product and take their contents diluted in 2 liters of water. Eight other sachets, also diluted in 2 liters of water will be taken 4 to 5 hours before the procedure. Fasting will be required from 2 hours after the investigational product has been taken."
16081490|NCT02297386|Drug|[18F] DIHYDRO-TESTOSTERONE|
16081491|NCT02297386|Device|PET scan|
16081492|NCT02297386|Device|MRI|
16081493|NCT02297386|Other|Blood draw|
16081494|NCT02297360|Dietary Supplement|Viviscal Extra-Strength Supplement|The key ingredient of Viviscal Extra-Strength Supplement is AminoMar C™ marine complex, Equisetum arvense sp. (horsetail), containing a naturally occurring form of silica), Malpighia glabra (acerola cherry) which contains Vitamin C, Biotin and Zinc. The AminoMar C™ is an active ingredient which has been trademarked and comprises of a proprietary blend of shark powder and mollusc powder. It is derived from sustainable marine sources. Viviscal provides essential nutrients to nourish hair naturally from within. The Viviscal supplement is compared to the placebo tablet which contains no active ingredients. One tablet is taken by mouth in the morning and evening with food.
16081495|NCT02297360|Other|Placebo tablet|The placebo tablet contains no active ingredients. One tablet is taken by mouth in the morning and evening with food.
16081496|NCT02297334|Device|CytoSorb device|In 20 patients the CytoSorb device will be installed into the extra corporeal circuit. A blood flow of 400ml/min is provided by an roller pump of the heart lung machine in a parallel stream to the main circulation.
16081497|NCT02297321|Device|Describe patch|Application of Describe patch over tattoo for approximately 5 minutes during Q-switched laser treatment
16081498|NCT02297295|Other|Physiotherapy|Physiotherapy three times a week for 8 weeks according to a well-defined protocol
16081499|NCT02297282|Behavioral|Behavioural Activation (BA)|Behavioural activation is a therapy, which has been shown to be quite effective in the treatment of depression. Originally a component of cognitive therapy, behavioural activation is the use of strategies such as activity scheduling, master/pleasure ratings, and graded task assignments to change one's perception of specific situations. It involves the use of activities to improve life situations or depressed mood.
16081500|NCT02297269|Device|laparoscopic surgery|the method of surgery is conducted by laparoscope with proper pressure of pneumoperitoneum instead of opening the abdomen.
16081501|NCT02297269|Device|open surgery|the method of surgery is conducted by surgical instruments to open the abdomen.
16081502|NCT02297256|Procedure|BMAC & Allograft|Use of Allograft infused with adult stem cells from the bone marrow aspirate harvested from the iliac crest during posterior lumbar/lumbosacral spinal fusion.
16081503|NCT02297256|Procedure|Iliac Crest Bone Graft|Use of iliac crest bone grafts (ICBG) during posterior lumbar/lumbosacral spinal fusion.
16081504|NCT02297243|Device|Sinopsys Lacrimal Stent|The Sinopsys Lacrimal Stent is indicated for use to create a transcaruncular ethmoid sinus access.
16081505|NCT02297230|Radiation|Radiation Therapy (RT)|Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, axillary fields, 45 Gy @ 1.8 Gy/fraction, + 14 Gy @ 2 Gy/fraction to the primary tumor. At the end of chemo-radiation, Trastuzumab will be continued weekly until surgery and as per standard of care after surgery for up to 1 year total.
16081506|NCT02297230|Drug|Capecitabine|Capecitabine (Xeloda®) 750 mg/m2 twice/daily given orally. Treatment should begin on day 1 of radiation therapy. The two doses should be taken about 30 minutes after eating (eg. after breakfast and after dinner). Treatment will be given for 10 weeks (for 6 weeks during radiation and for 4 weeks after radiation).
16081507|NCT02297230|Drug|Trastuzumab|Trastuzumab (Herceptin®) treatment will be administered weekly, together with one of the two weekly doses of Paclitaxel. The first dose will be 4mg/kg given IV over 90 minutes. Subsequent weekly doses will be given at a dose of 2 mg/kg/week IV over 30 minutes. The treatment with Trastuzumab will continue weekly after the completion of the radiation treatment until surgery and thereafter as per standard of care up to 1 year post surgery.
16081569|NCT02296749|Drug|Sirolimus|Sirolimus tablets 2 mg
16081570|NCT02296736|Radiation|Computerised tomography (CT) scan|Retrospective review of CT scans
16081508|NCT02297230|Drug|Paclitaxel|Paclitaxel 30 mg/m2 twice per week given IV over 1 hour. Treatment will be administered on a Monday/Thursday or Tuesday/Friday schedule.The radiation treatment will start within 1 week from the first dose of paclitaxel and trastuzumab. Pre-meds for paclitaxel should be based on the institutional standards; it is suggested that dexamethasone (Decadron®), 20 mg IV, be given with the first paclitaxel dose. If the patient tolerates the treatment, the dexamethasone may be tapered and/or discontinued for subsequent doses. Treatment will be given for 10 weeks (for 6 weeks during radiation and for 4 weeks following radiation).
16081509|NCT02297217|Drug|Carboplatin and Taxol (paclitaxel)|Patients will receive carboplatin (AUC 2) and paclitaxel (50 mg/m2) intravenously on Days 1 and 8. Patients are seen for 2 weekly Treatment Visits during concurrent chemo-radiation then every 28 days until the End of Study Visit, approximately 6 months after Treatment Visit 1. Preparation and administration of chemotherapy will be according to local site standard of care.
16081510|NCT02297217|Radiation|External Beam Radiation|Patients will receive external beam radiation therapy of 30Gy/10 fractions over two weeks (or reduced to 25 Gy/10 fractions if acute toxicity parameters are met during the run-in) and receive carboplatin (AUC 2) and paclitaxel (50 mg/m2) intravenously on Days 1 and 8. Treatment will be planned, prescribed and delivered using standard 3D radiotherapy planning techniques to encompass the primary tumor and surrounding clinical target volume. Patients are seen for 2 weekly Treatment Visits during concurrent chemo-radiation then every 28 days until the End of Study Visit, approximately 6 months after Treatment Visit 1.
16081511|NCT02297204|Procedure|Focal Laser Treatment|All subjects receiving PRN IVT aflibercept injections will be evaluated for focal laser treatment beginning at week 12 through the end of the study. If the subject meets any of the criteria for focal laser treatment (FLT), fluorescein angiography (FA) will be performed to guide the focal laser treatment. Focal laser treatment and focal laser re-treatment will be administered no more than once every 90 days.
16081512|NCT02297204|Drug|aflibercept 2.0 mg|If a subject has recurrent CR-DME they will receive an IVT aflibercept injection
16081513|NCT02297191|Procedure|Thoracolumbar Interfascial Plane Block|"All participants will have two injections at the same vertebral level on each side of the back. Each injection will consist of four 5cc incremental injections with aspiration prior to each 5cc of injectate of 0.5% Ropivicaine. . Each side of the back will be injected with 20cc of .05% Ropivicaine. Ultrasound will be used in real time to guide the needle.
~Ultrasound images will be saved using the nomenclature TLIP Anatomy
~Photos will only include surface anatomy of the low-to-mid back.
~Participants will be assessed for evidence of adverse reaction to local anesthesia (tinnitus, disorientation, or perioral numbness) with each 5cc dose of local anesthetic. If any adverse reactions are noted the dosing will be stopped."
16081514|NCT02297191|Drug|Ropivicaine|
16081515|NCT02297178|Procedure|Cystoscopy only|Cystoscopy performed for investigation and treatment of OAB and voiding dysfunction
16081516|NCT02297178|Procedure|Cystoscopy and Urethral dilatation|Cystoscopy and urethral dilatation performed for investigation and treatment of OAB and voiding dysfunction
16081517|NCT02297165|Behavioral|olfactory stimulation program|"8 individual sessions of olfactory stimulation at the rate of 2 sessions per week. 3 semi-directed interviews will be help (one at the beginning of the trial, the second 5 weeks later and the third at 6 month).
~For each session, patients have to smell two different odors (previously selected from a panel presented to the patient during first visits) and then they are invited to evoke memories and feelings related to each odor."
16081518|NCT02297152|Device|FLIP HOLE|The subjects had to use the masturbator aid at least five times per week for six weeks, during a minimum of five minutes without never overcoming half daily hour and during intercourse. The device Flip Hole is a masturbation aid made from Thermoplastic Elastomer (a silicone like substance) that the user inserts their penis in to for stimulation.
16081519|NCT02297139|Drug|Dasatinib|
16081520|NCT02297126|Other|Pharmacogenetic Intervention Arm (pharmacogenetic testing)|In the design of this trial, pharmacogenetic testing will be triggered by the incident prescription of one or more of the targeted medications listed in the control arm. The pharmacogenetic array to be used incorporates 51 genetic variants for the following 16 genes/transporters: ATP-binding cassette sub-family C member 2, ATP-binding cassette, sub-family C, member 4, Cytochrome P450 2B6, Cytochrome P450 2C19, Cytochrome P450 2C9, Cytochrome P450 2D6, Cytochrome P450 3A4/3A5, Cytochrome P450 4F2, Dihydropyrimidine dehydrogenase, Glucose-6-Phosphate Dehydrogenase, Human Leukocyte antigen-B, I interleukin-28B, Inosine Triphosphatase, Solute Carrier Organic Anion Transporter Family, Member 1B, Thiopurine methyltransferase and V vitamin K epoxide reductase complex, subunit 1.
16081521|NCT02297113|Device|Macintosh blade|conventional endotracheal intubation
16081522|NCT02297113|Device|C-MAC videolaryngoscope|
16081523|NCT02297100|Drug|Onabotulinumtoxin A|100 units of botox spread out among 10 separate injections
16081524|NCT02297100|Procedure|injections upper aspect of trigone of urinary bladder|We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.
16081525|NCT02297100|Procedure|injections on posterior bladder wall excluding the trigone|We hypothesize that injections into the trigone should be more effective in the treatment of IC than injections elsewhere in the bladder.
16081526|NCT02297087|Genetic|Standard of care based on target(s) identified via GWS.|
16081527|NCT02297074|Other|Ordinary white bread|"The evening before the test day, subjects consumed a standardised dinner. Volunteers arrived in a 12-h fasting state. A fasting blood sample was acquired after the resting time, and appetite feelings were assessed by using visual analogue The subjects were instructed to consume the tested bread or 50 g of glucose. The subjects immediately completed two VAS, one on appetite feelings and another on bread palatability. The appetite feeling VAS were repeated every 30 min until a total of 180 min had passed. The subjects were not allowed to eat or drink anything else during the 180 min of the intervention.
~After the last blood extraction (3 h), an ad libitum lunch and 300 ml of water was provided. Volunteers ate until comfortably satisfied and the amount of food intake was registered"
16081564|NCT02296788|Behavioral|Aerobic Exercise|The exercise expenditure goals were calculated by multiplying the participants' body weight by the exercise dose (8 or 20 KKW) divided by the number of sessions (3-5 sessions/wk). The speed and grade were monitored and documented to keep participant heart rate at 65-85% of tested VO2 peak and entered into ACSM equations for energy expenditure.
16081565|NCT02296775|Biological|DRL_RI|Two 1000 mg intravenous infusions, one each on Day 1 and Day 15
16081730|NCT02295722|Drug|Melphalan|200 mg/m2
16081528|NCT02297074|Other|Precooked-Frozen White Bread|"The evening before the test day, subjects consumed a standardised dinner. Volunteers arrived in a 12-h fasting state. A fasting blood sample was acquired after the resting time, and appetite feelings were assessed by using visual analogue The subjects were instructed to consume the tested bread or 50 g of glucose. The subjects immediately completed two VAS, one on appetite feelings and another on bread palatability. The appetite feeling VAS were repeated every 30 min until a total of 180 min had passed. The subjects were not allowed to eat or drink anything else during the 180 min of the intervention.
~After the last blood extraction (3 h), an ad libitum lunch and 300 ml of water was provided. Volunteers ate until comfortably satisfied and the amount of food intake was registered"
16081529|NCT02297074|Other|Candeal-flour White Bread|"The evening before the test day, subjects consumed a standardised dinner. Volunteers arrived in a 12-h fasting state. A fasting blood sample was acquired after the resting time, and appetite feelings were assessed by using visual analogue The subjects were instructed to consume the tested bread or 50 g of glucose. The subjects immediately completed two VAS, one on appetite feelings and another on bread palatability. The appetite feeling VAS were repeated every 30 min until a total of 180 min had passed. The subjects were not allowed to eat or drink anything else during the 180 min of the intervention.
~After the last blood extraction (3 h), an ad libitum lunch and 300 ml of water was provided. Volunteers ate until comfortably satisfied and the amount of food intake was registered"
16081530|NCT02297074|Other|Alfacar White Bread|"The evening before the test day, subjects consumed a standardised dinner. Volunteers arrived in a 12-h fasting state. A fasting blood sample was acquired after the resting time, and appetite feelings were assessed by using visual analogue The subjects were instructed to consume the tested bread or 50 g of glucose. The subjects immediately completed two VAS, one on appetite feelings and another on bread palatability. The appetite feeling VAS were repeated every 30 min until a total of 180 min had passed. The subjects were not allowed to eat or drink anything else during the 180 min of the intervention.
~After the last blood extraction (3 h), an ad libitum lunch and 300 ml of water was provided. Volunteers ate until comfortably satisfied and the amount of food intake was registered"
16081531|NCT02297074|Other|Wholemeal Bread|"The evening before the test day, subjects consumed a standardised dinner. Volunteers arrived in a 12-h fasting state. A fasting blood sample was acquired after the resting time, and appetite feelings were assessed by using visual analogue The subjects were instructed to consume the tested bread or 50 g of glucose. The subjects immediately completed two VAS, one on appetite feelings and another on bread palatability. The appetite feeling VAS were repeated every 30 min until a total of 180 min had passed. The subjects were not allowed to eat or drink anything else during the 180 min of the intervention.
~After the last blood extraction (3 h), an ad libitum lunch and 300 ml of water was provided. Volunteers ate until comfortably satisfied and the amount of food intake was registered"
16081532|NCT02297074|Other|Glucose|50 g of glucose were administered as a reference
16081533|NCT02297061|Biological|Thrombelastography analysis (TEG)|TEG analysis is performed on admission
16081534|NCT02297048|Dietary Supplement|Potassium depletion|Healthy subjects will be submitted twice at 15-30 day interval, to a low potassium diet (20mmol/day)
16081535|NCT02297035|Behavioral|Behavioural testing|
16081536|NCT02297035|Other|Brain imaging|MRI, PET
16081537|NCT02297035|Genetic|Genetic screening|APOE, Progranulin
16081538|NCT02297022|Device|Deep Brain Stimulation|Deep Brain Stimulation hypothalamic surgery in patients with Prader-Willi syndrome
16081539|NCT02297009|Procedure|Buccal swab|Buccal swabs will be taken from the volunteers
16081540|NCT02296996|Drug|Dabrafenib + Trametinib|
16081541|NCT02296983|Biological|VSV-ZEBOV|VSV-ZEBOV
16081542|NCT02296970|Procedure|Deep shave removal using a blue surgical blade|Removal of a skin lesion with 2mm margins and an adequate amount of tissue deeper than the clinical appearance of the lesion using a blue surgical blade
16081543|NCT02296957|Procedure|Hypnosedative discontinuation|Intervention towards hospital physicians to promote hypnosedative discontinuation in patients initiated during the hospital stay, intervention towards patients and their general practitioners to heighten awareness about the hypnosedative-related risks.
16081544|NCT02296944|Other|Collection of anatomical and functional results in the appearance of the tympanic membrane after surgery|
16081545|NCT02296931|Other|Saline|Standard IV Saline Fluids
16081546|NCT02296931|Drug|Magnesium Sulfate|The standard drug used to prevent and treat convulsions for women with pre-eclampsia and eclampsia is magnesium sulfate (MgSO4)
16081547|NCT02296918|Drug|acalabrutinib|100 mg twice daily continuous
16081548|NCT02296918|Drug|Obinutuzumab|Cycle 2 Day 1, 100 mg IV will be administered. Then on Cycle 2 Day 2, 900 mg administered. On Cycle 2 Days 8 and 15, 1000 mg IV will be administered. On Cycles 3-7, 1000 mg on Day 1 of each cycle will be administered.
16081549|NCT02296918|Drug|Venetoclax|20 mg daily for 1 week, 50 mg daily for 1 week, 100 mg daily for 1 week, 200 mg daily for 1 week, then 400 mg daily for duration of treatment.
16081550|NCT02296918|Drug|Rituximab|Rituximab will be given at a starting dose of 375 mg/m2 on Day 1 of Cycle 2, followed by 375 mg/m2 every week for 3 doses and then every 4 weeks for 5 doses for a total of 9 infusions
16081551|NCT02296905|Drug|ABT-493|Up to 2 single doses of ABT-493 will be given orally in combination with ABT-530.
16081552|NCT02296905|Drug|ABT-530|Up to 3 single doses of ABT-530 will be given orally alone or in combination with ABT-493.
16081553|NCT02296892|Drug|Remimazolam|For induction and maintenance of sedation
16081554|NCT02296892|Drug|Placebo|Inactive control arm
16081555|NCT02296892|Drug|Midazolam|For induction and maintenance of sedation
16081556|NCT02296879|Genetic|SAIT301|The treatment period will consist of 21-day cycles. On Day 1 of each cycle, SAIT301 will be administered as an intravenous (IV) infusion.
16081557|NCT02296853|Drug|TAF|25 mg tablet administered orally
16081558|NCT02296840|Drug|Ibuprofen|Ibuprofen 10mg/kg/day every 6-8 hours
16081559|NCT02296840|Drug|Hydrocodone-Acetaminophen|Hydrocodone-Acetaminophen 0.15mg/kg/day every 4-6 hours
16081560|NCT02296814|Drug|Sinusitis Hevert SL Tablet|1st week: 6 times daily 2 tablets and 2nd week: 4 times daily 2 tablets
16081561|NCT02296814|Drug|Placebo for Sinusitis Hevert SL Tablet|1st week: 6 times daily 2 tablets and 2nd week: 4 times daily 2 tablets
16081562|NCT02296801|Drug|Letrozole|
16081563|NCT02296801|Drug|palbociclib|
16081731|NCT02295722|Other|ASCT|Day 0 - Stem cell infusion
16081571|NCT02296723|Drug|Valganciclovir Hydrochloride|Valganciclovir Hydrochloride Tablets 450 mg
16081572|NCT02296710|Procedure|Echocardiographic and sleep apnea test|Echocardiographic evaluation (Vivid 7, GE) of systolic and diastolic function of both ventricles as well as evaluation of apnea-hypopnea index and type of apnea (ApneaLink®)
16081573|NCT02296697|Device|Low-level laser therapy AlGaInP|Pressure ulcers will be treated with AlGaInP 660 nm laser, wich will be used once a day, five days per week, dosed with 6 J/cm2. Laser therapy is applied punctually in each 1cm2 of the ulcer.
16081574|NCT02296697|Device|High-frequency therapy with O3 formation|High-frequency laser therapy will be applied with spherical electrode, wich contains neon gas inside, from a short distance from the pressure ulcer. The application will last 15 minutes, with increasing intensity from 80 to 100% for ozone formation, once a day, five days per week.
16081575|NCT02296697|Other|Wound dressing with saline solution|Wound dressing will be done daily on patients from the three groups during the study period. On patients who will receive laser therapy and high frequency, the pressure ulcer will be sanitized with worm saline solution in order to clean the wound. This cleaning will be done before and after the interventions.
16081576|NCT02296684|Biological|MK-3475 (neoadjuvant)|
16081577|NCT02296684|Procedure|Surgery|Standard of care
16081578|NCT02296684|Radiation|Intensity modulated radiation therapy|Recommended, standard of care
16081579|NCT02296684|Radiation|Image-guided radiation therapy|Recommended, standard of care
16081580|NCT02296684|Drug|Cisplatin|Standard of care
16081581|NCT02296684|Biological|MK-3475 (adjuvant)|
16081582|NCT02296684|Procedure|Peripheral blood|-Baseline, time of surgery (between day 14-24 inclusive), 3 months post surgery, 6 months post surgery, 9 months post surgery, 12 months post surgery
16081583|NCT02296671|Drug|Pemetrexed|
16081584|NCT02296671|Drug|Oxaliplatin|
16081585|NCT02296671|Drug|Leucovorin|
16081586|NCT02296671|Drug|Fluorouracil|
16081587|NCT02296671|Genetic|Germline genotyping analyses for TSER|
16081588|NCT02296658|Radiation|intensity-modulated radiotherapy|A total irradiation dose of 45 Gy was delivered in daily 1.8-Gy fractions (5 days a week over 5 weeks) to all patients.
16081589|NCT02296658|Drug|S-1|S-1,80mg/m2/d,peroral BID,in treatment days concurrently with intensity-modulated radiotherapy.
16081590|NCT02296645|Drug|ZuraPrep|Apply topically.
16081591|NCT02296645|Drug|ChloraPrep|Apply topically.
16081592|NCT02296632|Behavioral|Motion sensors and daily online assessments|Patients will be asked to wear motion sensors during their waking hours and complete daily Patient Reported Outcomes online assessments.
16081593|NCT02296619|Procedure|TAP block|Using real time ultrasound imaging, bilateral, 20 ml 0,25% bupivacaine inject into the area between the internal oblique and transverse abdominis muscle
16081594|NCT02296619|Procedure|Control|A sham band-aid will be applied to the abdomen of subjects
16081595|NCT02296593|Device|comparison of blood lactate and glucose levels|comparison of blood lactate and glucose levels with the reference method (co oxymetry) and a new central veinous catheter microdialysis system provided by MAQUET. (Critical Care AB, Solna, Sweden.)
16081596|NCT02296580|Device|Nativis Voyager RFE Therapy|Nativis Voyager Radiofrequency Energy Therapy
16081597|NCT02296567|Drug|Ranibizumab|Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care.
16081598|NCT02296567|Drug|Bevacizumab|Drug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care.
16081599|NCT02296567|Drug|Aflibercept|Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care.
16081600|NCT02296567|Drug|Ranibizumab|Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care.
16081601|NCT02296567|Drug|Bevacizumab|Drug: Bevacizumab Subjects will receive intravitreal Bevacizumab as part of their routine medical care
16081602|NCT02296567|Drug|Aflibercept|Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care
16081603|NCT02296567|Drug|Ranibizumab|Drug: Ranibizumab Subjects will receive intravitreal Ranibizumab as part of their routine medical care
16081604|NCT02296567|Drug|Bevacizumab|Drug: Bevacizumab Subjects will receive intravitreal bevacizumab as part of their routine medical care
16081605|NCT02296567|Drug|Aflibercept|Drug: Aflibercept Subjects will receive intravitreal Aflibercept as part of their routine medical care
16081606|NCT02296567|Other|Control Group|Control group Subjects will no previous anti-VEGF treatment
16081607|NCT02296554|Procedure|SLAP Repair|SLAP repair for SLAP tear
16081608|NCT02296554|Procedure|Biceps Tenodesis|Biceps tenodesis for SLAP tear
16081609|NCT02296541|Biological|DNA Nat-B env|4 mg to be administered as 1 mL intramuscularly (IM) by Biojector 2000® or with a needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated)
16081610|NCT02296541|Biological|DNA CON-S env|4 mg to be administered as 1 mL IM by Biojector 2000® or with a needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated)
16081611|NCT02296541|Biological|DNA Mosaic env|4 mg to be administered as 1 mL IM by Biojector 2000® or with a needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated)
16081612|NCT02296541|Biological|MVA-CMDR|1×10^8 plaque forming units (pfu) to be administered as 1 mL IM in the deltoid muscle of the non-dominant arm (unless medically contraindicated)
16081613|NCT02296541|Biological|Placebo for DNA Nat-B env|Sodium Chloride for Injection, 0.9% to be administered as 1 mL IM by Biojector 2000® or with a needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated)
16081614|NCT02296541|Biological|Placebo for DNA CON-S env|Sodium Chloride for Injection, 0.9% to be administered as 1 mL IM by Biojector 2000® or with a needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated)
16081615|NCT02296541|Biological|Placebo for DNA Mosaic env|Sodium Chloride for Injection, 0.9% to be administered as 1 mL IM by Biojector 2000® or with a needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated)
16081616|NCT02296541|Biological|Placebo for MVA-CMDR|Sodium Chloride for Injection, 0.9% to be administered as 1 mL IM in the deltoid muscle of the non-dominant arm (unless medically contraindicated)
16083577|NCT02282488|Other|Low protein formula|
16081617|NCT02296528|Device|Swallowing Expansion Device|"SED looks like the letter T and has a plate and a post. The plate is like the top part of the T or smooth part of the tack. The plate is attached to the cartilage or flexible connective tissue of the throat. The SED post is like the bottom part of the T with a small ring. The post permanently sticks out from the throat, like a skin piercing. The SED is made out of titanium because this metal is extremely strong and commonly used in medical devices put into the body, such as hip joints or bone plates."
16081618|NCT02296515|Procedure|Intrathecal pump refill:|Two different experienced clinicians will perform one time the blind technique andTwo different experienced clinicians will perform one time the blind technique andtwo times the ultrasound-guided technique on all patients.
16081619|NCT02296502|Other|DSM|Comparing use of DSM-IV versus DSM-5 criteria for autism spectrum disorder
16081620|NCT02296489|Device|Capnostream20p|The device will be used to monitor respiratory co2 values during the methacholine challenge, a well known diagnostic procedure
16081621|NCT02296476|Drug|Birabresib|Administered orally in a fasted state once daily.
16081622|NCT02296463|Biological|RSV F Vaccine with adjuvant (0.5mL injection)|
16081623|NCT02296463|Biological|RSV F Vaccine (0.5mL injection)|
16081624|NCT02296463|Biological|Hepatitis A Vaccine (0.5mL injection)|
16081625|NCT02296463|Biological|Placebo (0.5mL injection)|
16081626|NCT02296450|Behavioral|Quality of Life (QoL) Assessment|Per physician's discretion, the patient (or, if applicable, patient's family member/ spouse/ caregiver for FDLQI) will complete one or more of the following dermatology-specific QoL instruments: Skindex-16, Skindex-29 DLQI (Dermatology Life Quality Index), FDLQI (Family DLQI) - for patient's family member/spouse/caregiver ONLY, CDLQI (Children's DLQI;Cartoon version) - for patient's under the age of 18 ONLY-written, CDLQI (Children's DLQI; Cartoon version) - for patients under the age of 18 ONLY - cartoon version, FACT-G (Functional Assessment of Cancer Thearpy-General), FACT-Melanoma (Functional Assessment of Cancer Therapy-Melanoma), SCI (Skin Cancer Index) FACT-EGFRI-18 (Functional Assessment of Cancer Therapy-Epidermal Growth Factor Receptor Inhibitor-18), HFS-14 (Hand-Foot Syndrome) OMWQ (Oral Mucositis Weekly Questionnaire), ESTEEM, Hairdex , Skindex-29 modified for hair loss, Itchy QoL,CADS (Chemotherapy-induced alopecia distress scale)
16081627|NCT02296437|Other|Transcranial direct current stimulation combined with cognitive training|
16081628|NCT02296424|Drug|ACZ885 150 mg (Canakinumab)|Active canakinumab in individual 2 mL glass vials, each containing 150 mg canakinumab liquid in vial.
16081629|NCT02296411|Drug|CHF 5259 12.5 µg|comparison of CHF5259 versus placebo over 2 treatment periods of 6 weeks
16081630|NCT02296411|Drug|CHF 5259 placebo|comparison of CHF5259 versus placebo over 2 treatment periods of 6 weeks
16081631|NCT02296398|Drug|Romidepsin|Received romidepsin per standard of care or through a clinical trial for more than one cycle
16081632|NCT02296385|Dietary Supplement|Triple Strength Fish Oil|Triple Strength Fish Oil
16081633|NCT02296372|Device|Continuous glucose monitoring|"Continuous glucose monitoring by subcutaneous or intravasal device for 72 hours.
~In use MEDTRONIC SENTRINO® and Edwards GlucoClear® systems."
16081634|NCT02296359|Biological|Influenza Vaccination|The individuals will be followed to observe their immune system activation, following their vaccination with the standard influenza vaccine approved for the year by the FDA.
16081635|NCT02296346|Drug|SoluMedrol|Infusion of drug subcutaneously, once a month.
16081636|NCT02296346|Device|Extracorporeal Photopheresis|This intervention is the placement of up to two IV's to extract your blood as a set volume, separate out the white cells and return the red cells to your body. Then the white cells are treated with a drug called UVADEX (methoxsalen), excited by a UV light and returned to your body. Once IV is to withdraw your blood and the other is to return your blood to your body.
16081637|NCT02296333|Drug|ondansetron|8 mg intravenous in the skin closure
16081638|NCT02296333|Drug|isotonic|8 mg intravenous in the skin closure
16081639|NCT02296320|Drug|MEDI4893|Participants will receive a single IV dose of MEDI4893 2000 or 5000 mg on Day 1 of the study.
16081640|NCT02296320|Other|Placebo|Participants will receive a single IV dose of placebo matched to MEDI4893 on Day 1 of the study.
16081644|NCT02296294|Drug|Elo-mel® (Fresenius Kabi Austria)|an iv isotonic crystalloid fluid therapy at a rate of 0,50ml/kg/min for one hour.
16081645|NCT02296294|Device|Body Composition Monitoring|BCM measurements every 10 minutes for 6 hours.
16081646|NCT02296281|Drug|Pirfenidone|
16081647|NCT02296268|Behavioral|Aerobic Exercise Screening and Prescription Clinic|Patients will be referred to the Clinic by their physiotherapist to be assessed regarding their safety and readiness to participate in aerobic training. If they are deemed to be safe and ready, an aerobic exercise prescription will be written to guide the implementation of a safe and effective training protocol. Patients deemed to be at moderate to high risk will need to be cleared for testing by a physician on the stroke service. A cardiologist will be consulted about specific concerns re cardiac status.
16081648|NCT02296255|Biological|Cervarix®, GlaxoSmithKline|3 doses (0,1,6 months) of Cervarix®, GlaxoSmithKline
16081649|NCT02296242|Drug|BVD-523|Oral, multiple escalating doses, twice daily, for 21 days in each treatment cycle
16081650|NCT02296229|Radiation|stereotactic body radiation therapy|Undergo SBRT
16081651|NCT02296229|Other|quality-of-life assessment|Ancillary studies
16081652|NCT02296229|Other|laboratory biomarker analysis|Correlative studies
16081653|NCT02296229|Drug|androgen deprivation therapy|up to 9 months at the discretion of the treating physician
16081654|NCT02296216|Device|Gamma Knife radiosurgery|To determine potential long-term (superior to 10 years) extra-pituitary side-effects of Gamma Knife radiosurgery in patients treated for Acromegaly
16081655|NCT02296203|Drug|cetuximab|
16081656|NCT02296203|Drug|irinotecan|
16081657|NCT02296190|Drug|Etripamil|intranasal administration via 4 prefilled Aptar Pharma Unit-Dose Spray devices
16081658|NCT02296190|Drug|Placebo|intranasal administration via 4 prefilled Aptar Pharma Unit-Dose Spray devices
16081782|NCT02295293|Drug|Placebo|Placebo capsule: 1 capsule twice daily for 6 weeks
16081659|NCT02296177|Behavioral|Peace of Mind Program|The Peace of Mind Program (PMP) is a telephone counseling program based on the Transtheoretical Model of Change, with messages matched to readiness (assessed with a stage of change question)and barriers identified by women who are non-adherent to mammography. The program telephone protocol guides counselors to assess a woman's readiness to be screened and counsel her through barriers to increase appointment keeping.
16081660|NCT02296164|Drug|Valchlor|Valchlor gel 0.016%
16081661|NCT02296151|Other|Gluteus medius strengthening|Hip abductor, gluteus medius strengthening
16081662|NCT02296151|Other|iliotibial band stretches|Iliotibial band stretches
16081663|NCT02296138|Drug|olodaterol|fixed dose combination
16081664|NCT02296138|Drug|tiotropium|fixed dose combination
16081665|NCT02296138|Drug|tiotropium|
16081666|NCT02296125|Drug|AZD9291 80 mg/40 mg + placebo|"The initial dose of AZD9291 80 mg once daily can be reduced to 40 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment.
~Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria."
16081667|NCT02296125|Drug|Placebo Erlotinib 150/100mg|The initial dose of Placebo Erlotinib 150 mg once daily can be reduced to Placebo 100 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
16081668|NCT02296125|Drug|Placebo Gefitinib 250 mg|The initial dose of Placebo Gefitinib 250 mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
16081669|NCT02296125|Drug|Erlotinib 150/100 mg|"The initial dose of Erlotinib 150mg once daily can be reduced to 10 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment.
~Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
~Following objective disease progression according to RECIST 1.1, as per investigator assessment, patients who were randomized to Standard of Care arm may have the option to receive open-label AZD9291 (crossover to active AZD9291)."
16081670|NCT02296125|Drug|Gefitinib 250 mg|"The initial dose of Gefitinib 250mg once daily cannot be reduced. A cycle of treatment is defined as 21 days of once daily treatment.
~Number of Cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
~Following objective disease progression according to RECIST 1.1, as per investigator assessment, patients who were randomized to Standard of Care arm may have the option to receive open-label AZD9291 (crossover to active AZD9291)."
16081671|NCT02296125|Drug|Placebo AZD9291 80 mg/ 40 mg|The initial dose of Placebo AZD9291 80 mg once daily can be reduced to Placebo AZD9291 40 mg once daily under specific circumstances. A cycle of treatment is defined as 21 days of once daily treatment. Number of cycles: as long as patients are continuing to show clinical benefit, as judged by the Investigator, and in the absence of discontinuation criteria.
16081672|NCT02296112|Drug|trametinib|Given PO
16081673|NCT02296112|Other|laboratory biomarker analysis|Correlative studies
16081674|NCT02296112|Other|pharmacological study|Correlative studies
16081675|NCT02296099|Drug|liposomal bupivacaine|Liposomal bupivacaine 20 mL diluted with 10 mL normal saline. Ten mL of solution to be injected into the vaginal epithelium in the mid-urethral area and 10 mL injected into each of the trocar paths through the suprapubic incisions bilaterally.
16081676|NCT02296099|Drug|Placebo|Normal saline 30 mL total injected. Ten mL injected into the vaginal epithelium in the mid-urethral area and 10 mL will be injected into each of the trocar paths through the suprapubic incisions bilaterally.
16081677|NCT02296073|Drug|Midazolam|midazolam 3～5μg/kg•min for maintenance of sedation.
16081678|NCT02296073|Drug|Dexmedetomidine|Dexmedetomidine 0.5μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation；
16081679|NCT02296073|Drug|Dexmedetomidine|Dexmedetomidine 0.25μg/kg intravenous bump for 15 min，then 0.2～1.4μg/(kg.h) for maintenance of sedation；
16081680|NCT02296073|Drug|Dexmedetomidine|Dexmedetomidine 0.2～1.4μg/(kg.h) for maintenance of sedation；
16081681|NCT02296073|Drug|Fentanyl|Fentanyl 0.5～4 μg/(kg.h) for maintenance of analgesia
16081682|NCT02296073|Other|assessment|Ramsay score for sedation assessment, Facial expression, leg movement, activity, cry, and consolability score (FLACC) for analgesia assessment.
16081683|NCT02296060|Procedure|6 minutes walking test|
16081684|NCT02296047|Drug|Placebo|physiological saline
16081685|NCT02296047|Drug|ipratropium bromide|80 µg inhalation once
16081686|NCT02296047|Drug|salbutamol|400 µg inhalation once
16081687|NCT02296021|Drug|Berberine|Berberine-containing quadruple therapy group: given for 14 days at a dose of berberine 100 mg 5 tablets BID, esomeprazole 20 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.
16081688|NCT02296021|Drug|Bismuth|Bismuth-containing quadruple therapy group: given for 14 days at a dose of colloidal bismuth tartrate capsule 55 mg 4 capsules BID, esomeprazole 20 mg BID, amoxicillin 500 mg 2 capsules BID, and clarithromycin 500 mg 1 tablet BID.
16081689|NCT02296021|Drug|esomeprazole|Esmeprazole 20mg 1tablet BID plus amoxicillin 500 mg 2 capsules BID, clarithromycin 500 mg 1 tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or berberine 100 mg 5 tablets BID as a dose given for bismuth-containing quadruple therapy or berberine-containing quadruple therapy.
16081690|NCT02296021|Drug|amoxicillin|Amoxicillin 500 mg 2 capsules BID plus esmeprazole 20mg 1tablet BID, clarithromycin 500 mg 1 tablet BID, and colloidal bismuth tartrate capsule 55 mg 4 capsules BID or berberine 100 mg 5 tablets BID as a dose given for bismuth-containing quadruple therapy or berberine-containing quadruple therapy.
16081691|NCT02296021|Drug|clarithromycin|Clarithromycin 500 mg 1 tablet BID plus amoxicillin 500 mg 2 capsules BID, esmeprazole 20mg 1tablet BID, and colloidal bismuth tartrate capsule55 mg 4 capsules BID or berberine 100 mg 5 tablets BID as a dose given for bismuth-containing quadruple therapy or berberine-containing quadruple therapy.
16081692|NCT02296008|Device|3D high resolution anorectal manometry|"Procedure will take about 15 minutes. During procedure resting, squeeze, bear down maneuver, cough, ano-anal and rectoanal inhibitory reflex will be obtained, if possible.
~3D picture of pressures of anorectal will be recorded."
16081693|NCT02295995|Behavioral|Exercise as an Adjuvant Therapy for Veterans with PTSD|Methods: Approximately 50 Veterans 60 years and older with PTSD will be recruited to participate in a 12-week physical activity program consisting of aerobic and strength-training activities. Participants will be randomized to an intervention arm or usual care wait-list control. Outcomes: Changes in physical function, PTSD symptom severity, and aerobic endurance will be assessed between the two study arms. Secondary outcomes include compliance with the intervention, pain, sleep, and psychological well-being.
16081694|NCT02295982|Procedure|Hand assisted laparoscopic nephrectomy|patients with renal cancer will undergo hans assisted laparoscopic nephrectomy
16081695|NCT02295969|Drug|Oralair|Observational study, Oralair is used as prescribed by the prescriber phycisian.
16081696|NCT02295956|Behavioral|Questionnaires|Series of physical and quality of life assessments administered to participants, taking about 20 minutes to complete.
16081697|NCT02295956|Other|Exercise|Participants instructed to perform resistance/strengthening exercises for 30 minutes two times each week. Participants to walk 20-30 minutes at least 3 times a week. Participants issued a set of 3 resistance exercise bands with which the exercises can be performed.
16081698|NCT02295956|Other|Nutrition Counseling|Within 7 days after being enrolled on study, participant meets with a dietitian to discuss nutrition.
16081699|NCT02295956|Behavioral|Phone Calls|Participants receive phone calls from study staff every 2 weeks for 6 weeks to check for adherence, and if they are having any side effects from the exercise.
16081700|NCT02295956|Other|Booklet|Exercise instructional booklet given to all participants describing all exercises.
16081701|NCT02295943|Other|Positioning measuring device|Vitrectomy, intraocular gas fill. The supine time during the first postoperative day is measured
16081702|NCT02295930|Other|folfoxiri+cetuximab+surgery+cetuximab|"Induction FOLFOXIRI plus cetuximab will consist of:
~CETUXIMAB 500 mg/sqm IV over 1-h* , day 1 followed by
~IRINOTECAN 130 mg/sqm IV over 1-h, day 1 followed by
~OXALIPLATIN 85 mg/sqm IV over 2-h, day 1 concomitantly with
~l-LV 200 mg/sqm IV over 2-h, day 1 followed by
~5-FLUOROURACIL 2400 mg/sqm IV 48-h continuous infusion, starting on day 1 repeated every 2 weeks for 8 cycles.
~Surgical revaluation will be performed after the induction phase (8 cycles).
~Patients deemed unsuitable for surgery will received maintenance treatment as follows:
~•CETUXIMAB 500 mg/sqm IV over 60-min, day 1 repeated every 2 weeks until PD, patient's refusal, unacceptable toxicity or consent withdrawal."
16081703|NCT02295930|Other|folfoxiri+cetuximab+surgery+bevacizumab|"Induction FOLFOXIRI plus cetuximab will consist of:
~CETUXIMAB 500 mg/sqm IV over 1-h* , day 1 followed by
~IRINOTECAN 130 mg/sqm IV over 1-h, day 1 followed by
~OXALIPLATIN 85 mg/sqm IV over 2-h, day 1 concomitantly with
~l-LV 200 mg/sqm IV over 2-h, day 1 followed by
~5-FLUOROURACIL 2400 mg/sqm IV 48-h continuous infusion, starting on day 1 repeated every 2 weeks for 8 cycles.
~Surgical revaluation will be performed after the induction phase (8 cycles).
~Patients deemed unsuitable for surgery will received maintenance treatment as follows:
~•BEVACIZUMAB 5 mg/kg IV over 30-min, day 1 repeated every 2 weeks until PD, patient's refusal, unacceptable toxicity or consent withdrawal."
16081704|NCT02295917|Device|Transvaginal sonography|Transvaginal sonography
16081705|NCT02295891|Device|MiraDry ®|Non-invasive thermolytic technology which utilizes a microwave energy-based mechanism targeted for eccrine gland reduction at the dermal-fat interface
16081706|NCT02295878|Dietary Supplement|Treatment capsule containing seaweed extract (treatment)|400mg capsule containing seaweed extract (treatment)
16081707|NCT02295878|Dietary Supplement|Placebo|
16081708|NCT02295865|Drug|JNJ-38518168 60 mg|Two tablets of JNJ-38518168, 30 milligram (mg) each for a total of 60 mg, orally, once daily.
16081709|NCT02295865|Drug|JNJ-38518168 30 mg|One tablet of JNJ-38518168, 30 mg, orally, once daily.
16081710|NCT02295865|Drug|JNJ-38518168 3 mg|One tablet of JNJ-38518168, 3 mg, orally, once daily.
16081711|NCT02295865|Drug|Placebo|Matching Placebo either 30 mg tablet or 3 mg tablet will be administered orally.
16081712|NCT02295852|Dietary Supplement|LOW-SODIUM LOW LIPID CALCIUM RICH DIET|1.Composition of the diet: Proteins 17%, Total lipids 28%, Saturated Fatty Acids 7%, Carbohydrates 54%, Fibers 42 g, Sodium 1377 mg, potassium 4067mg, Calcium 1211 mg
16081713|NCT02295852|Dietary Supplement|LOW-SODIUM LOW LIPID DIET|2. Composition of the diet: Proteins 17%, Total lipids 27%, Saturated Fatty Acids 7%, Carbohydrates 56%, Fibers 39 g, Sodium 1397 mg, potassium 3973 mg, Calcium 650 mg
16081714|NCT02295839|Behavioral|Sleep Hygiene and Relaxation Education|Intervention group participants receive a nurse-led, one-hour 1:1 educational session including education about sleep in children and a description of what is known about sleep and fatigue issues in children with cancer. The session also includes strategies to improve sleep hygiene in children. Information about relaxation to promote sleep is outlined and two children's books designed to promote relaxation using the principles of deep breathing are given to the parent(s). A handout containing all the information covered is given to the parent(s).
16081715|NCT02295826|Drug|Dabigatran|Dabigatran will be taken bid for 30 days post enrolment. The dose of dabigatran will be based on patient age and renal function.
16081716|NCT02295826|Drug|Acetylsalicylic acid|participants randomized to ASA therapy will be loaded with 325 mg of ASA, followed by 81 mg/day
16081717|NCT02295813|Biological|FBF001|
16081718|NCT02295813|Drug|Placebo|
16081719|NCT02295800|Other|Standard of care|
16081720|NCT02295800|Other|Semi-structured interviews|
16081721|NCT02295787|Drug|Ketamine|Intranasal ketamine for late-life depression and suicidal ideation.
16081722|NCT02295787|Drug|Placebo|
16081723|NCT02295774|Procedure|standard white light colonoscopy-equivalent to placebo|standard white light colonoscopy
16081724|NCT02295774|Drug|Methylene Blue MMX tablets|8x25mg methylene blue MMX tablets administered before a colonoscopy
16081725|NCT02295761|Behavioral|Lifestyle counseling (Fb)|Facebook-delivered lifestyle counseling
16081726|NCT02295761|Behavioral|Lifestyle counseling + activity monitor (Fb+Act)|Facebook-delivered lifestyle counseling and self-monitoring physical activity using Polar activity monitor
16081727|NCT02295748|Drug|Deflazacort|Deflazacort, a glucocorticoid with anti-inflammatory and immunosuppressive effects, is used in treating a variety of diseases. Pharmacologically it is an inactive pro-drug which is metabolized rapidly to the active drug 21-desacetyldeflazacort.
16081728|NCT02295735|Device|Mepilex® Border Sacrum and Mepilex® Border Heel|
16081729|NCT02295722|Drug|Gemcitabine|gemcitabine 1.5 g/m2 INFUSED
16081783|NCT02295280|Drug|Metoclopramide|IV
16081732|NCT02295709|Procedure|SNR steroid (dexamethasone) injection|"deliver steroids (dexamethasone) into spinal nerve root with the guidance of ultrasound.
~Device: Ultrasound (S-Nerve; SonoSite, Bothell, Wash), Probe 9L (6 MHz, SonoSite, Bothell, Wash)"
16081733|NCT02295709|Procedure|CTF steroid (dexamethasone) injection|"deliver steroids (dexamethasone) into spinal epidural space with the guidance of ultrasound.
~Device: Ultrasound (S-Nerve; SonoSite, Bothell, Wash), Probe 9L (6 MHz, SonoSite, Bothell, Wash)"
16081734|NCT02295709|Drug|Dexamethasone|One of the most efficient steroids
16081735|NCT02295709|Device|Ultrasound|Ultrasound (S-Nerve; SonoSite, Bothell, Wash), Probe 9L (6 MHz, SonoSite, Bothell, Wash)
16081736|NCT02295709|Radiation|C arm|the needle position will be re-confirmed by C arm C arm (Philips Healthcare, Best, the Netherlands）
16081737|NCT02295696|Behavioral|EMMA|Consultations using dialogue tools
16081738|NCT02295683|Device|Renal Denervation|
16081739|NCT02295670|Device|Vividtrac|video-laryngoscopy
16081740|NCT02295670|Device|MIL|direct-laryngoscopy
16081741|NCT02295657|Device|standard double-lumen tube|intubation using standard double-lumen tube
16081742|NCT02295657|Device|VivaSight Double Lumen Tube|intubation using VivaSight Double Lumen Tube
16081743|NCT02295644|Device|Ultrasound Sonicator 740|Therapeutic ultrasound (Ultrasound Sonicator 740) used on masseter muscle, 1MHz, 5 minutes
16081744|NCT02295631|Device|Standard tracheal tube|ETI with standard tracheal tube and Macintosh laryngoscope
16081745|NCT02295631|Device|ETView VivaSight SL|ETI with ETView VivaSight SL
16081746|NCT02295618|Device|Standard tracheal tube|Intubation using Macintosh laryngoscope and standard tracheal tube
16081747|NCT02295618|Device|ETView VivaSight SL|Intubation using ETView VivaSight SL
16081748|NCT02295605|Other|water-based exercises|water-based exercise strengthening protocol for lower limb muscles
16081749|NCT02295605|Other|land-based exercises|land-based exercise strengthening protocol for lower limb muscles
16081750|NCT02295592|Procedure|TSTstarr+|"TSTstarr+ : a kind of modified STARR（stapled transanal rectal resection ） operation, compared to the traditional STARR operation, it does not need two staplers but with a larger diameter stapler,  + means better . Patients in group A with severe prolapsed hemorrhoids will undergo TSTstarr+ operation ."
16081751|NCT02295592|Procedure|PPH|PPH is short fo procedure for prolapsed hemorrhoids .Patients in group B with severe prolapsed hemorrhoids will undergo PPH operation.
16081752|NCT02295579|Other|lactobacillus (EcoVag)|Probiotic human lactobacillus (L. gasseri and L rahmnosus)
16081753|NCT02295566|Drug|Nitric Oxide|Not required
16081754|NCT02295566|Drug|Control|Not required
16081755|NCT02295553|Drug|Ketamine|
16081756|NCT02295553|Drug|Propofol|
16081757|NCT02295540|Radiation|hypofractionated radiation therapy|Undergo hypofractionated IMRT
16081758|NCT02295540|Radiation|intensity-modulated radiation therapy|Undergo hypofractionated IMRT
16081759|NCT02295540|Procedure|therapeutic conventional surgery|Undergo surgery
16081760|NCT02295540|Other|laboratory biomarker analysis|Correlative studies
16081761|NCT02295527|Other|Home-based physical exercise intervention|Progressive strengthening of muscle groups ankle dorsi flexors, knee extensors and hip abductors and progressive balance training according to individual capacity:weight-bearing, limits of stability, change of position/direction, maintenance of static and dynamic stability, anticipatory adjustments using different bases of support and different sensory conditions. Dynamic exercises involving spin on its own axis, sitting and standing, up and down stairs, functional reach, steps in different directions and walk training. In the first session the physiotherapist will choose two exercises that best address the participant function goals and will add more exercises each week according to the level of participants' ability and motivation. Participants will receive a detailed booklet, containing photos and instructions of the12 exercises.Visits to follow up exercises will be conducted by the physiotherapists to progress the exercises.
16081762|NCT02295527|Other|Control Group Usual Care|This group will receive usual care and will not have any disadvantage in participating in the study. We understand that usual care is what participant receives based on the network of health care in which he/she is inserted. The participants will receive at baseline assessment a diary falls logbook and a guidance booklet containing information about prevention of falls, fractures and bone health that will be explained at the moment.
16081763|NCT02295514|Biological|PTP1B dosage|PTP1B sampled and dosed during sepsis
16081764|NCT02295501|Biological|INTERCEPT Plasma|Plasma will be collected from eligible volunteer donors who have recovered from acute EVD (see EBOV convalescent donor inclusion criteria). This donor plasma will be collected by apheresis donation (approximately 650-1300 mL per donation at physician discretion) and treated with the IBS for plasma.
16081765|NCT02295488|Procedure|biological sampling|blood intake for biological sampling during validated desensitization protocol (Alyostall®)
16081766|NCT02295488|Biological|Desensitization protocol (Alyostall®)|Validated desensitization protocol using Alyostall® performed
16081767|NCT02295475|Drug|Apixaban|
16081768|NCT02295475|Drug|Warfarin|
16081769|NCT02295462|Other|Person-centered Care|Medication Review + Person-centered Care
16081770|NCT02295462|Other|Optimised Treatment|Medication Review only
16081771|NCT02295449|Device|biopsy sample performed after the SonoVue® injection|
16081772|NCT02295436|Drug|minodronic acid|comparison of different doses, ages and medication conditions
16081773|NCT02295410|Behavioral|CPT|
16081774|NCT02295397|Other|food|food provocation, skin testing, blood sampling
16081775|NCT02295384|Other|Retrospective Audit|Retrospective Audit
16081776|NCT02295345|Other|Cognitive Behavioural Therapy for Insomnia|
16081777|NCT02295332|Drug|Placebo|Matching oral placebo capsules to RG7625, according to treatment schedule
16081778|NCT02295332|Drug|RG7625|oral administration, capsules, single ascending dose according to treatment schedule
16081779|NCT02295319|Other|Individual discharge|"See previous description in Arms"
16081780|NCT02295306|Device|Respiratory Volume Monitor (RVM, ExSpiron)|Connecting patient to the ExSpiron monitor and continuous ExSpiron data collection during the patient's polysomnography (PSG)
16081781|NCT02295293|Drug|Rhus Coriaria L. (Rhus)|500 mg of Rhus Coriaria L. (Rhus) powder in capsule: 1 capsule twice daily for 6 weeks
16081784|NCT02295280|Drug|Diphenhydramine|iv
16081786|NCT02295267|Other|walnut allergy provocation|double blind placebo controlled food challenge
16081787|NCT02295254|Other|feces sample|The travelers will give feces sample before and after the travel. The sample microorganisms will be analyzed.
16081788|NCT02295241|Other|No intervention|This is an observational trial, no interventions are being used.
16081789|NCT02295228|Other|No intervention|There are no interventions. This is an observational trial.
16081790|NCT02295215|Other|Exercise|Exercise Training for 4 months
16081791|NCT02295202|Device|CPAP (REMstar System One Plus - Philips Medical Systems)|Standard device for treating obstructive sleep apnea.
16081792|NCT02295202|Device|Nasal strips|
16081793|NCT02295189|Drug|Ketorolac Tromethamine|anti-inflammatory injection
16081794|NCT02295189|Drug|Triamcinolone Acetonide|corticosteroid injection
16081795|NCT02295176|Dietary Supplement|Armolipid Plus|
16081796|NCT02295176|Dietary Supplement|Placebo|
16081797|NCT02295163|Procedure|Stellate ganglion block|7 ml of 0.5% bupivacaine will subsequently be injected next to the stellate ganglion to produce a sympathetic block.
16081798|NCT02295163|Procedure|Sham procedure|7 ml of 0.9 % sodium chloride will subsequently be injected next to the stellate ganglion
16081799|NCT02295150|Drug|Nadroparin|Patients receive before surgery 3 days 2850 IU nadroparin. anti-Xa levels will be measured. After surgery they receive 5700 IU for 4 weeks as standard care in our hospital. 3 days and 4 weeks after surgery anti-Xa levels will be measured again.
16081800|NCT02295137|Procedure|Using pre-procedural CTA to guide advanced EVAR procedure|
16081801|NCT02295124|Drug|Oxycodone|Patients will receive oxycodone 10mg (5mg if > 65) every 2 hours based on an equianalgesic dose calculation. As per routine practice, the dose will be titrated according to the patient's pain at the discretion of the Acute Pain Service physician who will not be blinded to group allocation.
16081802|NCT02295124|Drug|Hydromorphone|Patients will receive an initial dose of hydromorphone 2mg (1mg if > 65) every 2 hours as needed based on an equianalgesic dose calculation. As per routine practice, the dose will be titrated according to the patient's pain at the discretion of the Acute Pain Service physician who will not be blinded to group allocation.
16081803|NCT02295111|Device|EA treatment|Electro acupuncture and traditional Chinese Medicine Health consult
16081804|NCT02295111|Behavioral|TCM health consult|Traditional Chinese Medicine Health Consult without needling
16081805|NCT02295111|Other|Usual Care|Standard NHS care
16081806|NCT02295098|Other|Thoracic epidural catheter placement|Thoracic epidurals work by delivering local anesthetics and narcotics to the epidural space, which then diffuse into the spinal nerve roots and block the transmission of pain from the chest wall to the spinal cord and brain.
16081807|NCT02295098|Other|Paracostal catheter placement|Paracostal catheters run along the outer surface of the chest wall and act by delivering local anesthetics to the intercostal nerves as traverse the lower border of the ribs.
16081808|NCT02295072|Behavioral|A 5-months physical exercise-based program|"The physical exercise program consists of 3-5 after-school sessions/week of 90 min plus exercise homework in the weekends, and will focus on high-intensity aerobic exercise mainly."
16081809|NCT02295059|Dietary Supplement|omega 3 fatty acids|supplied as soft gelatin capsules for oral administration
16081810|NCT02295046|Drug|Amlodipine besylate/Atorvastatin calcium|Amlodipine besylate/Atorvastatin calcium 10/80 mg
16081811|NCT02295033|Radiation|Boost irradiation|
16081812|NCT02295020|Drug|Standard treatment only|Standard treatment such as NSAIDs and injections
16081813|NCT02295020|Device|Standard treatment plus Bioskin Ten-7 knee brace|Standard treatment such as NSAIDs and injections plus Bioskin Ten-7 knee brace.
16081814|NCT02295007|Behavioral|text message|
16081815|NCT02294994|Drug|tirofiban|
16081816|NCT02294981|Device|Excimer laser phototherapy|Excimer laser phototherapy is a type of ultraviolet light that is applied to psoriatic plaques. It is administered using a laser in a targeted way so that only the plaques are treated (normal skin is not treated).
16081817|NCT02294968|Other|Family Startup (in Danish: Familieiværksætterne)|Manualized parenting support program; see Center for Socialt Ansvar (2013)
16081818|NCT02294955|Device|Catheterablation|Pulmonary vein isolation using either Arctic Front™ Cardiac CryoAblation or irrigated radiofrequency catheter ablation. A linear lesion, a left atrial roof line, is optional for patients with AF recurrence after a first procedure or primarily for patients with persistent AF.
16081819|NCT02294955|Drug|Amiodarone|Dosage orally 600 mg once daily for 7-10 days, and 100-200 mg once daily thereafter.
16081820|NCT02294955|Drug|Sotalol|Dosage orally 80-160 mg twice daily
16081821|NCT02294955|Drug|Flecainide|Dosage orally 100 to 150 mg twice daily or the entire dose as slow-release formula once daily
16081822|NCT02294955|Drug|Propafenone|Dosage orally 300 mg twice daily
16081823|NCT02294955|Drug|Disopyramide|Dosage orally 250-375 mg twice Daily
16081824|NCT02294955|Drug|Dronedarone|Dosage orally 400 mg twice daily
16081825|NCT02294942|Drug|RANCAD|Extended-Release RANCAD
16081826|NCT02294929|Procedure|Atrial fibrillation ablation|Atrial fibrillation ablation using the Arctic Front™ Advance Cardiac CryoAblation Catheter in two balloon sizes (23mm and 28mm) for pulmonary vein isolation
16081827|NCT02294916|Device|AWS|Video-laryngoscopy 1
16081828|NCT02294916|Device|Intubrite|Video-laryngoscopy 2
16081829|NCT02294916|Device|AirTraq|Optical-laryngoscopy
16081830|NCT02294916|Device|MIL|Direct-laryngoscopy
16081831|NCT02294903|Procedure|Coiled Bipolar Radiofrequency Ablation|Radiofrequency ablation by use of bipolar electrodes
16081832|NCT02294890|Procedure|Total knee arthroplasty|
16081833|NCT02294877|Drug|Vimizim® (elosulfase alfa)|Recombinant human N acetylgalactosamine 6 sulfatase (rhGALNS)
16081834|NCT02294864|Device|Percutaneous Pulsed Radiofrequency|Pulsed Radiofrequency
16081835|NCT02294864|Procedure|Physical Therapy|
16081836|NCT02294851|Drug|BMS-986168|
16081837|NCT02294851|Drug|BMS-986168 Placebo|
16081838|NCT02294838|Device|MRI|Participants will undergo MR imaging of the parotid gland pre and post stimulation. Perfusion images will be acquired using a time-resolved, spoiled GE sequence with 1×1×2 mm spatial resolution, approximately one second 3D temporal resolution, and image technique/contrast parameters TR = 2.8 ms and TE = 0.9 ms.
16083578|NCT02282488|Other|High protein formula|
16081839|NCT02294838|Other|Citric acid|5 mls of 2% citric Acid will be delivered to the oral cavity via a syringe and Tygon tubing at two separate time intervals in order to stimulate the parotid gland during the MRI scanning process.
16081840|NCT02294838|Other|Gadovist|Upon commencement of the scan, 0.05 ml/kg of Gadovist (at 4 ml/s) and 20 ml of saline flush (also at 4 ml/s) will be administered.
16081841|NCT02294825|Procedure|various surgical procedures in endometriosis|Shaving, disc excision and colorectal resection; ureterolysis or ureter resection; bladder resection; ablation of endometriomas using plasma energy; excision and ablation of deep and superficial lesions
16081842|NCT02294812|Behavioral|Cognitive training|"Participants will engage in eight weeks of training that focuses on improving various cognitive abilities. For example, short term memory.
~Cognitive training will take place 30 minutes per day, five days per week, for eight weeks. Training will be done in the participant's own home using web-based software. Participants will be randomly assigned to either the active control group, the control cognitive training group, or the experimental cognitive training group following the second study visit.
~After eight weeks, participants will no longer partake in training."
16081843|NCT02294799|Procedure|Intervention Group|Grade 1, Nonspecific Mandibular Mobilization. 3 times a week during 4 weeks.
16081844|NCT02294786|Drug|Lapatinib|Lapatinib was supplied as 250mg tablets that are oval, biconvex, and orange film-coated with one side plain and the opposite side debossed, or as 250mg tablets that are oval, biconvex, and yellow film-coated with one side plain and the opposite side debossed. Each tablet contained 405mg of Lapatinib ditosylate monohydrate, equivalent to 250mg Lapatinib free base
16081845|NCT02294786|Drug|Capecitabine|Capecitabine (Xeloda™) was supplied as a biconvex, oblong, light peach or peach colored film-coated tablet for oral administration. Each light peach colored tablet contained 150mg Capecitabine and each peach colored tablet contained 500mg Capecitabine. Generic versions of capecitabine may have been used within the study if Xeloda cannot be provided. XELODA™ is a trademark of Hoffmann-La Roche AG.
16081846|NCT02294786|Drug|Octreotide|Octreotide (Sandostatin LAR™) was supplied as sterile 5milliliter (mL) vials delivering 20mg Octreotide as the free peptide. When mixed with diluent (approximately 2mL or 2.5 mL) it becomes a suspension that is given as an intramuscular injection. Two 20mg intramuscular injections were given to deliver a total dose of 40mg. The Octreotide is uniformly distributed within the microspheres which are made of a biodegradable glucose star polymer, D,L-lactic and glycolic acids copolymer. Sterile mannitol was added to the microspheres to improve suspendability
16081847|NCT02294773|Procedure|Intrauterine Insemination|Intrauterine insemination is either performed on the day the home ovulation predictor kit first turns positive or the day after the first positive.
16081848|NCT02294773|Drug|Clomiphene|Patient is to take clomiphene citrate during cycle days 3-7.
16081849|NCT02294773|Drug|Letrozole|Patient is to take letrozole during cycle days 3-7.
16081850|NCT02294760|Device|Subsensory|The stimulation is set to 90% of the sensory threshold.
16081851|NCT02294760|Device|OFF|The stimulation is turned OFF.
16081852|NCT02294747|Device|Sliding Hip Screw with Trochanteric Stabilization Plate|
16081853|NCT02294747|Device|Sliding Hip Screw without Trochanteric Stabilization Plate|
16081854|NCT02294734|Drug|GSK2269557|Dry powder for inhalation via DISKUS 'device' with unit dose strength of 500 micrograms (mcg) per actuation with total dose of 1000 mcg daily
16081855|NCT02294734|Drug|Placebo|Dry powder for inhalation via DISKUS 'device'
16081856|NCT02294721|Device|Standard BLS|Resuscitation without feedback devices, standard manual standard basic life support
16081857|NCT02294721|Device|The CPREazy|feedback device-1
16081858|NCT02294721|Device|TrueCPR|feedback device -2
16081859|NCT02294721|Device|The CPR PRO APP|feedback device -3
16081860|NCT02294721|Device|The CardioPump|feedback device- 4
16081861|NCT02294708|Behavioral|postoperative postures|two postoperative postures: supine and temporal-lateral
16081862|NCT02294682|Drug|GSK2140944|Immediate release capsules (pink hard gelatin size 00 capsule, with no external marking, filled with slightly agglomerated pale yellowish to grayish yellow powder) containing GSK2140944 500 mg and inactive formulation excipients. GSK2140944 will be administered orally once 1500 mg (3 capsules) or 3000 mg (6 capsules).
16081863|NCT02294669|Device|Turris Facet Fuser|Study participants will have a Turris Facet Fuser inserted into the contralateral facet joint, instead of a state of the art contralateral pedicle screw system.
16081864|NCT02294656|Drug|Ranibizumab,|Intravitreal injection of Ranibizumab as treatment for acute pseudophakic cystoid macular edema. Ranibizumab patients will receive three monthly Ranibizumab 0.5 mg/0.05 mL injections, followed by PRN dosing, as treatment for acute pseudophakic cystoid macular edema.
16081865|NCT02294656|Drug|Triamcinolone acetonide|Intravitreal injection of Triamcinolone acetonide as treatment for acute pseudophakic cystoid macular edema. Triamcinolone acetonide patients will receive PRN Triamcinolone acetonide 4 mg/0.1 mL injections, every 3 months, as treatment for acute pseudophakic cystoid macular edema.
16081866|NCT02294643|Drug|Sarpogrelate|
16081867|NCT02294643|Drug|Aspirin|
16081868|NCT02294643|Drug|Clopidogrel|
16081869|NCT02294643|Drug|Placebo (for Sarpogrelate)|
16081870|NCT02294630|Drug|Surfactant|Two doses of surfactant to be administered as aerosol will be tested - 100 mg phospholipid/kg and 200 mg phospholipid/kg. Each dose will be tested at two dilutions and with two nebulizers. Each enrolled infant may receive a maximum of two aerosol treatments of a single dilution with a single nebulizer.
16081871|NCT02294617|Other|Electronic Cigarette|Subject will use electronic cigarette for 3 days.
16081872|NCT02294617|Other|Nicotrol Inhaler|Subjects will use the Nicotrol Inhaler for 3 days.
16081873|NCT02294604|Device|ethyl alcochol, chlorhexidine and moisturizers|
16081874|NCT02294604|Device|chlorhexidine|
16081875|NCT02294604|Device|povidone-iodine|
16081876|NCT02294591|Drug|N-acetylcysteine|Add-on treatment of NAC
16081877|NCT02294591|Drug|Placebo|Add-on treatment of placebo
16081878|NCT02294565|Drug|VST-1001|Single-dose injection (peritumoral, periareolar, and/or intradermal) of VST-1001 administered pre-SLNB procedure; VST-1001 is used with medical devices (blue-light LED illuminator and blue-light filtering eyewear) for lymphatic mapping and localization of lymph nodes during a SLNB procedure.
16081954|NCT02294084|Drug|Sitagliptin|Each subject in this arm will receive Sitagliptin (100mg/day) for a duration of 12 weeks.
16081879|NCT02294565|Drug|99mTc-labeled sulfur colloid|Single-dose injection (peritumoral, periareolar, intradermal, and/or subdermal) of 99mTc-labeled sulfur colloid administered per standard of care; the radioactivity of the radioactive colloid is detected with a gamma probe per standard of care.
16081880|NCT02294552|Drug|Cyclophosphamide|
16081881|NCT02294552|Drug|Busulfan|
16081882|NCT02294552|Drug|Fludarabine monophosphate|
16081883|NCT02294552|Drug|Tacrolimus|
16081884|NCT02294552|Drug|Mycophenolate mofetil|
16081885|NCT02294552|Procedure|Allogeneic hematopoietic stem cell transplantation|
16081886|NCT02294539|Drug|Losartan 50mg/amlodipine 5mg|once daily, 1T, PO medication
16081887|NCT02294539|Drug|Losartan 100mg/amlodipine 5mg|once daily, 1T, PO medication
16081888|NCT02294539|Drug|Losartan 50mg/Hydrochlorothiazide 12.5mg|once daily, 1T, PO medication
16081889|NCT02294539|Drug|Losartan 100mg/Hydrochlorothiazide 25mg|once daily, 1T, PO medication
16081890|NCT02294526|Other|Sardine diet|Diet rich in sardine: 100g/day of sardine 5 times a week
16081891|NCT02294513|Device|Standard audiologic rehabilitation (incl. HI)|The intervention consists of standard audiologic rehabilitation in which participants are fit with at least one hearing instrument (HI).
16081892|NCT02294474|Drug|SAR342434|SAR342434 100 U/mL (dose range of 1 Unit to 80 Units) self-administered by subcutaneous (SC) injection, immediately (within 5 -10 minutes) before meals intake. Dose adjusted to achieve 2 hour post prandial glucose (PPG) in range of 6.7 to 8.9 mmol/L (120 to 160 mg/dL) while avoiding hypoglycemia.
16081893|NCT02294474|Drug|Humalog|Humalog 100 U/ml (dose range of 1 unit to 60 units) self-administered by SC injection, immediately (within 5-10 minutes) before meals intake. Dose adjusted to achieve a 2 hour PPG in range of 6.7 to 8.9 mmol/L (120 to 160 mg/dL) while avoiding hypoglycemia.
16081894|NCT02294474|Drug|insulin glargine HOE901|Insulin glargine 100 U/mL injected QD subcutaneously consistent with the local label. Doses adjusted to achieve glycemic target for fasting, preprandial plasma glucose (SMPG) between 4.4 to 7.2 mmol/L (80 to 130 mg/dL) without hypoglycemia.
16081897|NCT02294448|Drug|Qishe Pill|Qishe Pill is a thin 0.15 g film-coated pill, composed of processed Radix Astragali, Muscone, Szechuan Lovage Rhizome, Radix Stephaniae Tetrandrae, Ovientvine, and Calculus Bovis Artifactus, which should be taken orally with water (240mL) after a minimum 10-hour fast
16081898|NCT02294435|Device|Visceral Manifold and Thoracic Bifurcation|Visceral Manifold and Thoracic Bifurcation Endovascular stent graft system
16081899|NCT02294435|Device|Unitary Manifold|Unitary Manifold Endovascular stent graft system
16081900|NCT02294422|Device|PBP|the pilot balloon is continuously palpated o felt for adequate pressure as its being inflated.
16081901|NCT02294422|Device|LOR|
16081902|NCT02294422|Device|Aneroid manometer|The pilot balloon is attached onto the manometer and cuff pressures are raed off from the gauge.
16081903|NCT02294409|Behavioral|Manualized group Cognitive-behavioral therapy (CBT) for social anxiety in first episode psychosis|All CBT sessions will be conducted in English or French by trained clinicians with the aid of a group CBT script that we have developed over the last two years. The script will provide a general outline for each session, remind the therapist about relevant CBT principles, and provide examples of topics and homework that may be useful in each session. This intervention will include: i) Psychoeducation on social anxiety disorder; ii) Cognitive Restructuring; iii) Exposure component; iv) Use of Thought Records to identify, explore and dispute negative thoughts about dysfunctional self-identity and core beliefs related to the onset and presence of diagnosis of schizophrenia. The latter module specifically examines stigmatization and self-stigmatization that are contributing factors to social anxiety. Each of the 13 group sessions consisting of 6-8 participants on average, will last for 1.5 hour each. One session per week will be provided for the 13-week period.
16081904|NCT02294409|Behavioral|Group Computer assisted cognitive remediation therapy|This group intervention has been developed by Dr. Bowie a co-applicant on the current proposal. This intervention involves completing cognitive training activities on a computer, documenting and attempting new strategies for solving problems, and doing 'bridging activities'. The target domains of cognition to be trained are processing speed, attention, memory and executive functions. The investigators will perform 13 weekly sessions of 1.5 hours. The software Brain Training Pro (http://www.scientificbraintrainingpro.fr), which has been used extensively in the field of schizophrenia, will be used. Each 1.5 hour session will be conducted with groups of 6-8 participants. The therapist's interventions, while minimal, are meant to emphasize the link between activities in the CACRT sessions and day-to-day activities that people do.
16081905|NCT02294396|Drug|Mirabegron tablet|orally administered at a dose of 1 tablet once daily after breakfast
16081906|NCT02294396|Drug|Solifenacin tablet|orally administered at a dose of 1 tablet once daily after breakfast (could be increased to 2 tablets)
16081907|NCT02294396|Drug|Propiverine tablet|orally administered at a dose of 1 tablet once daily after breakfast (could be increased to 1 tablet twice daily after breakfast and after dinner)
16081908|NCT02294396|Drug|Imidafenacin tablet|orally administered at a dose of 1 tablet (0.1 mg tablet) twice daily after breakfast and after dinner (could be increased to 2 tablets twice daily after breakfast and after dinner)
16081909|NCT02294396|Drug|Tolterodine capsule|orally administered at a dose of 1 capsule once daily after breakfast (could not be increased)
16081910|NCT02294357|Drug|Carfilzomib|
16081911|NCT02294357|Drug|Dexamethasone|If the patient was receiving steroids at the equivalent of > 8 mg of dexamethasone weekly either intravenously (IV) or Per Orem (PO) in combination with carfilzomib, the same drug(s), dose(s) and schedule(s) of steroids will be continued. If the patient was not receiving steroids or was receiving less than the equivalent of 8 mg of dexamethasone weekly, then he/she will be given 8 mg of dexamethasone (IV or PO) prior to each carfilzomib administration.
16081912|NCT02294357|Drug|Prednisone|f the patient was receiving prednisone, at the equivalent of > 8 mg of dexamethasone weekly PO in combination with carfilzomib, he/she will continue to receive prednisone at the same dose and schedule.
16081913|NCT02294357|Drug|Methylprednisolone|If the patient was receiving methylprednisolone at the equivalent of > 8 mg of dexamethasone weekly either IV or PO in combination with carfilzomib, he/she will continue to receive methylprednisolone at the same dose and schedule.
16081955|NCT02294084|Drug|placebo|Each subject will receive a placebo (once a day) for 12 weeks.
16081914|NCT02294357|Drug|Lenalidomide|given at same dose and schedule as patient was receiving while being treated with twice weekly carfilzomib at 27 mg/m2
16081915|NCT02294357|Drug|Pomalidomide|administered PO at 4mg daily on days 1-21 of a 28 day cycle
16081916|NCT02294344|Other|DFPP&CTX|"First,patients received methylprednisolone pulse therapy followed by oral prednisone and intravenous cyclophosphamide (IV-CTX) pulse therapy.
~Then double volume of plasma was processed during each DFPP session every two day. A fraction plasma separator(Asahi Kasei Medical, surface area 2.0 m2,pore size 0.03 mm)and another fraction plasma separator (Asahi Kasei Medical, surface area 2.0 m2, pore size 0.01 mm)were used as first and second filter for plasma fractionation, respectively. 1.5 volume of plasma was processed, and 35~45g human albumin and blood plasma was supplemented during each session. The patients were treated with DFPP every two days for at least 3 times. After DFPP, 300-500ml blood plasma was supplemented."
16081917|NCT02294344|Drug|CTX|"First,patients received methylprednisolone pulse therapy followed by oral prednisone and intravenous cyclophosphamide (IV-CTX) pulse therapy.
~After three months therapy, if the renal function was not recover, the patient would be withdrawn from the study. The other patients after CTX pulse therapy for 6 months and achieve remission to receive oral maintenance therapy with azathioprine (AZA).
~The dosage of AZA was 1.0-2.0mg/kg/d(more than 50mg/d) and adjusted by white cell count and liver enzyme. If white cell count <3×109/L or an increase in liver enzyme to more than twice the normal upper limit, the dosage of AZA should be reduced. If white cell count <3×109/L or liver enzyme increased repeatedly, the patient would be withdrawn from the study."
16081918|NCT02294318|Behavioral|HealthCall+Motivational Interviewing|HealthCall is a technology-based enhancement to brief MI to improve behavior outcomes. It is introduced to patients by the study counselor at the end of the MI session.
16081919|NCT02294318|Behavioral|Motivational Interviewing|Motivational Interviewing is a client-centered counseling approach for eliciting behavior change.
16081920|NCT02294305|Drug|Vortioxetine|
16081921|NCT02294305|Drug|Placebo|
16081922|NCT02294292|Drug|Carvedilol|Carvedilol started to achieve target HR (heart rate) reduction to 60/min, to a lowest permissible 50-55/ min ; provided Systolic Blood Pressure> 90 mmHg.
16081923|NCT02294292|Drug|Ivabradine|"Carvedilol started to achieve target HR (heart rate) reduction to 60/min, to a lowest permissible 50-55/ min ; provided Systolic Blood Pressure> 90 mmHg.
~If carvedilol is not tolerated,Ivabradine is added in a dose starting 2.5 mg BD to a maximum of 15 mg/day to ensure targeted heart rate reduction"
16081924|NCT02294292|Procedure|Endoscopic Variceal Ligation|
16081925|NCT02294279|Drug|Qvar (100 mcg)|2 puffs twice daily; 400 mcg daily over 4 weeks treatment period
16081926|NCT02294266|Drug|Mephedrone and alcohol|"Single oral dose mephedrone
~Single oral dose alcohol"
16081927|NCT02294266|Drug|Mephedrone|Single oral dose mephedrone
16081928|NCT02294266|Drug|Alcohol|Single oral dose alcohol
16081929|NCT02294266|Drug|Placebo|Single oral dose placebo
16081930|NCT02294253|Drug|Buprenorphine/naloxone|30 day oral Buprenorphine/naloxone
16081931|NCT02294240|Dietary Supplement|Energy dense biscuits|Energy dense biscuits will be provided
16081932|NCT02294240|Other|Wheat Flour, oil, iron & Folic acid|Wheat flour, oil, iron and folic acid will be provided
16081933|NCT02294227|Biological|Secukinumab|Secukinumab 150 mg (1 mL liquid formulation) in pre-filled syringes were supplied by Novartis. Each secukinumab 300 mg dose was given as two sc injections of secukinumab 150 mg.
16081934|NCT02294227|Other|Placebo|Placebo to secukinumab was also available in 1.0 mL liquid formulation in prefilled syringe to match the active drug.
16081935|NCT02294214|Device|Spatial Repellent product with active ingredient|Spatial Repellent Product - Passive Emanator. The name of the product is SHIELD from SCJohnson
16081936|NCT02294214|Device|Active ingredient|Transfluthrin (Active ingredient)
16081937|NCT02294214|Device|Spatial Repellent product without active ingredient (SHIELD)|Spatial Repellent Product - Passive Emanator. The name of the product is SHIELD from SCJohnson
16081938|NCT02294201|Device|Spatial Repellent product with active ingredient|Spatial Repellent product
16081939|NCT02294201|Device|Active ingredient|Transfluthrin (Active ingredient)
16081940|NCT02294201|Device|Spatial Repellent product without active ingredient (SHIELD)|Spatial Repellent Product - Passive Emanator. The name of the product is SHIELD from SCJohnson
16081941|NCT02294188|Device|Spatial Repellent product with active ingredient (SHIELD)|Spatial Repellent Product
16081942|NCT02294188|Device|Active ingredient|Transfluthrin (Active ingredient)
16081943|NCT02294188|Device|Spatial Repellent product without active ingredient (SHIELD)|Spatial Repellent Product - Passive Emanator. The name of the product is SHIELD from SCJohnson
16081944|NCT02294175|Device|Larval Debridement Therapy|small sterile mesh bags containing live maggots placed into an open chronic wound to remove necrotic tissue and bacterial biofilm
16081945|NCT02294175|Procedure|Bedside Sharp Debridement|The use of a sharp clinical instrument (currette, scalpel, scissors, forceps) by a qualified clinician to remove necrotic tissue and bacterial biofilm from an open chronic wound
16081946|NCT02294162|Drug|Ketamine i.v|
16081947|NCT02294149|Drug|mammalian Omega 3 Fatty acids|A mammalian oil derived Omega 3 FA that is a further concentrated and purified supplement as compared to the regular fish oil derived Omega 3 FA supplement.
16081948|NCT02294149|Drug|placebo|
16081949|NCT02294136|Behavioral|Prep-C|PREP-C is a web-based structured clinical interview that healthcare providers of diverse disciplines can be trained to administer. It provides an assessment of a client's psychosocial readiness to begin HCV treatment and identifies domains of functioning which require tailored intervention to improve treatment readiness.
16081950|NCT02294136|Behavioral|Educational Control|Attention Control
16081951|NCT02294123|Other|3 tortillas and white bread|Type crossover clinical trial in adults 20-69 years. Three groups of participants were included for each category (n = 27 in each group): 1) adults with diabetes, b) adults with overweight c) clinically healthy adults. The glycemic and insulinemic index was measured for each group of participants given in random order the 3 types of Tortilla and white bread
16081952|NCT02294110|Other|spinal anesthesia|non diabetes mellitus
16081953|NCT02294097|Procedure|Surveillance protocol kidney allograft biopsy|Surveillance protocol biopsy under ultrasound-guided will perform at post-operative day 7, month 3, month 6, month 12, and month 24
16084421|NCT02276378|Drug|Hydrochlorothiazide (HCTZ)|
16081956|NCT02294071|Drug|Ibuprofen|oral liquid ibuprofen 10mg/kg (maximum 600 mg)
16081957|NCT02294071|Drug|Acetaminophen|oral liquid acetaminophen 15mg/kg (max 975mg)
16081958|NCT02294058|Drug|Ozanimod|Capsules for oral administration once a day
16081959|NCT02294058|Drug|Interferon beta-1a|Administered by intramuscular injection once a week
16081960|NCT02294058|Drug|Placebo to ozanimod|Matching placebo capsules administered orally once a day
16081961|NCT02294058|Drug|Placebo to interferon beta-1a|Placebo intramuscular injection once a week
16081962|NCT02294032|Drug|Immunosuppressive Agents|standard of care for patients post-transplant
16081963|NCT02294019|Drug|Ibuprofen 400 mg caplet|400 milligram (mg) caplet according to Drug Facts label
16081964|NCT02294006|Drug|Everolimus plus Octreotide LAR plus Metformin|Everolimus plus Octreotide LAR plus Metformin
16081965|NCT02293993|Drug|SGI-110|
16081966|NCT02293980|Drug|PART 1: PT2385 Tablets|PT2385 inhibits HIF-2α and is a novel approach to treatment for this patient population.
16081967|NCT02293980|Drug|PART 2: PT2385 Tablets in combination with nivolumab|PT2385 inhibits HIF-2α and in combination with nivolumab is a novel approach to treatment for this patient population.
16081968|NCT02293980|Drug|PART 3: PT2385 Tablets in combination with cabozantinib|PT2385 inhibits HIF-2α an upstream regulator of VEGF activation. In combination with the VEGF inhibitor cabozantinib tablets, this is a novel approach to treatment for this patient population.
16081969|NCT02293967|Drug|MT-1303|
16081970|NCT02293954|Procedure|radionuclide imaging|Given copper Cu 64 anti-CEA monoclonal antibody M5A IV
16081971|NCT02293954|Procedure|positron emission tomography|Undergo PET
16081972|NCT02293954|Other|laboratory biomarker analysis|Correlative studies
16081973|NCT02293954|Other|pharmacological study|Correlative studies
16081974|NCT02293954|Drug|Cu 64 anti-CEA monoclonal antibody M5A IV|Cu 64 anti-CEA monoclonal antibody M5A IV
16081975|NCT02293941|Drug|JKB-122 5mg|Participants were randomized to receive JKB-122 5mg for 12 weeks
16081976|NCT02293941|Drug|JKB-122 15mg|Participants were randomized to receive JKB-122 15mg for 12 weeks
16081977|NCT02293941|Drug|JKB-122 35mg|Participants were randomized to receive JKB-122 35mg for 12 weeks
16081978|NCT02293941|Drug|Placebo|Participants were randomized to receive comparable placebo for 12 weeks
16081979|NCT02293928|Procedure|Hybrid coronary revascularization|Hybrid coronary revascularization with standard double antiplatelet therapy
16081980|NCT02293915|Drug|Sodium oligo-mannurarate 900mg|sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
16081981|NCT02293915|Drug|Placebo|simulant of sodium oligo-mannurarate capsule
16081982|NCT02293902|Drug|Sarilumab SAR153191 (REGN88)|Pharmaceutical form: solution for injection Route of administration: subcutaneous
16081983|NCT02293902|Other|Placebo (for sarilumab)|Pharmaceutical form: solution for injection Route of administration: subcutaneous
16081984|NCT02293902|Drug|Methotrexate|Dispensed according to local practice.
16081985|NCT02293902|Drug|Folic acid|Dispensed according to local practice.
16081986|NCT02293889|Dietary Supplement|Vitamin D3 2000IU/daily 3 months|Vitamin D will be provided in the form of a daily capsule over 3 months containing 2000IU of Vitamin D3 suspended in oil (manufactured and provided by DSM) with the aim of raising 25OHD levels to sufficiency (>50nmol/L) by 3 months.
16081987|NCT02293889|Behavioral|PA intervention People with Osteoarthritis Walking Programme|The PA intervention will aim to increase levels of PA safely in our defined population. Participant are given a pedometer at the start of the intervention and encouraged to record their daily step counts and set step goals using the online system provided (POW: People with osteoarthritis walking programme).
16081988|NCT02293889|Other|Placebo capsule (Vitamin D): edible oil|Placebo capsules will be administered over 3 months, as daily capsules (identical to Vitamin D capsules) containing edible oil (manufactured and provided by DSM)
16081989|NCT02293876|Device|LACRIBELL®|Hypromellose and dextran based eyedrop, used in the treatment of dry eye.
16081990|NCT02293876|Device|LIPOSIC®|Carbomer and Sorbitol based gel, used in the treatment of dry eye.
16081991|NCT02293876|Device|Glad wrap|A clear plastic wrap occluding eye and orbital area, turning the space into a moisture chamber.
16081992|NCT02293863|Drug|MHAA4549A|Participants will receive a single dose of MHAA4549A by IV infusion on Day 1
16081993|NCT02293863|Drug|Oseltamivir|Participants will receive oseltamivir capsule either 75 mg or 150 mg BID orally for minimum of 5 days. Dosage and administration should follow local prescribing information for oseltamivir.
16081994|NCT02293863|Drug|Placebo|Participants will receive a single IV dose of placebo matched to MHAA4549A on Day 1
16081995|NCT02293850|Biological|OBP-301|A range of dose levels is investigated and the starting dose is 1x1010 VP/tumor. Dose administration will be conducted through a dose-escalating scheme from 1x1010 VP/tumor to 1x1011 VP/tumor, 1x1012 VP/tumor, 3x1011 VP/tumor and 3x1012 VP/tumor.
16081996|NCT02293837|Drug|Tocilizumab (TCZ)|Subjects assigned to this group will receive tocilizumab intravenous (IV) infusions of either 8.0 mg/kg (body weight ≥ 30kg) or 10.0 mg/kg (body weight <30kg) every 4 weeks for 24 weeks.
16081997|NCT02293837|Drug|Placebo|Subjects assigned to this group will receive placebo intravenous (IV) infusions of either 8.0 mg/kg (body weight ≥ 30kg) or 10.0 mg/kg (body weight <30kg) every 4 weeks for 24 weeks.
16081998|NCT02293837|Other|Standard of Care|Participants will also receive standard intensive diabetes management (in accordance with the American Diabetes Association guidelines [Standard of Care, SOC])
16081999|NCT02293824|Drug|Caffeine|Given per standard of care.
16082000|NCT02293811|Other|Analysis|"An additional blood sample (10ml) will be taken on the day of hospitalization to achieve the genomic studies in search of mutations in constitutional DNA of circulating lymphocytes and acquired mutations of DNA circulating.
~We will use the technique of tissue-microarray to analyze the expression level of P2RX7 both in epithelial cells than in stromal cells inflammatory.
~Genotyping will be conducted partly on colonic biopsies and also on blood samples (to demonstrate the feasibility of this technique much less debilitating)."
16082001|NCT02293798|Device|silk surgical scaffold|surgical implant
16082002|NCT02293785|Drug|Oxycodone-Naloxone|
16082003|NCT02293772|Other|Hypoxic ambulatory|21 days confinement in normobaric hypoxic (FiO2 = 14%) environment
16082049|NCT02293395|Drug|Acetylsalicylic acid|ASA 100 mg enteric-coated tablet once daily orally.
16082004|NCT02293772|Other|Hypoxic Bedrest|21 days supine bedrest in normobaric hypoxic (FiO2 = 14%) environment
16082005|NCT02293772|Other|Normoxic Bedrest|21 days supine bedrest in normobaric normoxic (FiO2 = 21%) environment
16082006|NCT02293759|Procedure|HoLEP|Holmium laser enucleation of the prsotate
16082007|NCT02293759|Procedure|Greenlight laser PVP|Greenlight laser (532nm) Photoslective vaporization of the prostate
16082008|NCT02293746|Device|Inspire® Upper Airway Stimulation (UAS) System|This is a single-arm study; all participants will be implanted with the Inspire® Upper Airway Stimulation (UAS) System is a permanent, implantable therapy device, which consists of three implantable components: an IPG, a stimulation lead, and a sensing lead. In addition, the patient receives a remove to activate the therapy.
16082009|NCT02293720|Device|EndoBarrier|The EndoBarrier is indicated as an adjunct to diet and exercise to achieve weight loss and improve glycemic control in obese adults with type 2 diabetes whose anti-diabetes medications have not achieved adequate glycemic control.
16082010|NCT02293707|Biological|GX301|"GX301 therapy consists of four human telomerase reverse transcriptase (hTERT) peptides and two adjuvants.
~Peptides are hTERT (540-548) Acetate, hTERT (611-626) Acetate, hTERT (672-686) Acetate and hTERT (766-780) Acetate. Adjuvants are Montanide ISA 51 VG and imiquimod 5% cream (Aldara).
~Each GX301 administration will consist of four intradermal injections - one injection for each hTERT peptide - given at the same time and followed by topical application of imiquimod. Each intradermal injection will consist of a fixed hTERT peptide dose, 500 µg, reconstituted as a solution and mixed with Montanide ISA 51 VG."
16082011|NCT02293694|Drug|Sayana Press|Sayana® Press is a subcutaneous formulation of depot medroxyprogesterone acetate (DMPA) in a prefilled, auto-disabled injection system called Uniject
16082012|NCT02293681|Drug|Infliximab|This is an observational study. Participants receiving intravenous infusion of infliximab will be observed.
16082013|NCT02293681|Drug|NSAIDs|This is an observational study. Participants receiving aspirin, ibuprofen and naproxen as NSAIDs will be observed.
16082014|NCT02293681|Drug|DMARDs|This is an observational study. Participants receiving methotrexate (MTX), sulfasalazine, and thalidomide as DMRADs will be observed.
16082015|NCT02293668|Drug|FSH 225IU and hMG 225IU|
16082016|NCT02293668|Drug|FSH 150IU and hMG 150IU|
16082017|NCT02293668|Drug|Letrozole 5mg and hMG 150IU|
16082018|NCT02293655|Drug|OROS-Methylphenidate (MPH)|OROS-methylphenidate will be taken orally once daily at doses that have been approved for the study age group by the U.S. FDA.
16082019|NCT02293629|Drug|BMS-986147|
16082020|NCT02293629|Drug|Placebo matching BMS-986147|
16082021|NCT02293616|Dietary Supplement|Nitrate Rich Beetroot Juice|Nitrate rich beetroot juice diet supplement will be consumed by subjects.
16082022|NCT02293616|Dietary Supplement|Placebo|
16082023|NCT02293603|Biological|Allogeneic Cardiosphere-Derived Cells (CDCs)|Intracoronary delivery of CAP-1002 or placebo
16082024|NCT02293590|Drug|Certolizumab Pegol|
16082025|NCT02293577|Device|continuous glucose monitor|In this study all subjects will wear a continuous glucose monitor for 5 days.
16082026|NCT02293564|Drug|gevokizumab|Solution for subcutaneous injection
16082027|NCT02293551|Drug|Lispro|Administered SC
16082028|NCT02293538|Drug|FID 114657 eye drops (10 ml)|Lubricating eye drop for temporary relief of burning and irritation due to dryness of the eye
16082029|NCT02293538|Drug|Saline control eye drops (15 ml)|Saline eye drops (15 ml)
16082030|NCT02293538|Device|Habitual contact lenses|Commercially marketed biweekly or monthly replacement soft contact lenses as prescribed by eye care practitioner, brand and power
16082031|NCT02293525|Device|ReLeaf catheter|Continuous infusion rate 10ml/hr (5ml/side)
16082032|NCT02293525|Drug|Ropivacaine|
16082033|NCT02293525|Drug|Saline|
16082034|NCT02293525|Drug|Morphine|Patient-controlled analgesia (PCA) at 1mg every 6 minutes with a 4 hour lock out after 30mg
16082035|NCT02293525|Drug|Oxycodone|10mg every 4-6 hours
16082036|NCT02293512|Behavioral|Coping Effectiveness Training|A CET psychoeducational intervention is provided to increase understanding of stress and coping with tinnitus, and to better learn how to match appropriate coping strategies, based on whether the stressful situation is changeable or not.
16082037|NCT02293512|Behavioral|Cognitive-behavioral therapy|CBT treatments for tinnitus target the reduction of psychopathology by altering cognitive distortions, automatic thoughts, and core beliefs, as well as behavioral techniques to reduce physiological arousal.
16082038|NCT02293512|Behavioral|Acceptance and Commitment Therapy|An ACT psycho-educational intervention to reduce distress and resistance about having tinnitus and to increase committed actions based on one's values.
16082039|NCT02293499|Behavioral|PLASMA|"A structured asthma self-management manual (Let's Talk about Asthma [LTAA],developed by the study team will be utilized in a camp like setting and administered by either peers or adults medical professionals. The manual adheres to the 2007 NAEPP Guidelines Training strategies will involve didactic sessions, discussion, demonstrations, and role-play. Group learning activities will closely align with the program manual (LTAA) that consists of three sessions. Participants will also learn and practice skills in using the peak flow meter, spacer and inhaler, daily symptom diary and asthma action plan. Besides instructional activities, participants will engage in recreational activities that each camp site."
16082040|NCT02293486|Dietary Supplement|Pomegranate juice|Intake of 200 ml of pomegranate juice or pomegranate juice dilution during 21 days after exercise.
16082041|NCT02293473|Device|LiDCO Rapid|LiDCO Rapid haemodynamic monitor
16082042|NCT02293473|Device|BIS-Bispectral Index Monitor|Depth of anaesthesia
16082043|NCT02293473|Device|INVOS-Cerebral Oxygenation Monitor|regional brain tissue oxygenation
16082044|NCT02293473|Other|Standard of care|Using standard of care
16082045|NCT02293460|Drug|I10E|"Patients who meet all eligibility criteria will receive one dose of IMP at 2g/kg over 2-5 days followed by 7 doses of IMP at 1g/kg over 1-2 day(s), every 3 weeks.
~Duration of treatment period: 21 weeks +/- 7 days."
16082046|NCT02293447|Drug|Lidocaine per-embolization|10mL of 1% lidocaine will be mixed with the embolization particles. Lidocaine will therefore be injected during the embolization.
16082047|NCT02293447|Drug|Lidocaine post-embolization|10mL of 1% lidocaine will be injected in both uterine arteries after the embolization endpoint is achieved.
16082048|NCT02293421|Other|Obstructive sleep apnea|
16084422|NCT02276378|Other|Japanese meal|
16082050|NCT02293395|Drug|Rivaroxaban|Rivaroxaban 2.5 mg tablet twice daily orally.
16082051|NCT02293395|Drug|Clopidogrel|Clopidogrel 75 mg once daily orally.
16082052|NCT02293395|Drug|Ticagrelor|Ticagrelor 90 mg twice daily orally.
16082053|NCT02293369|Procedure|Cuff closure via vaginal route|Vaginal cuff will be closed via vaginal route during total laparoscopic hysterectomy.
16082054|NCT02293369|Procedure|Cuff closure via laparoscopic route|Vaginal cuff will be closed via laparoscopic route during total laparoscopic hysterectomy.
16082055|NCT02293356|Drug|Nimotuzumab Injection|patients receive nimotuzumab injection for 200mg/w,intravenous infusion over 60 minutes.Doctor adjust the dosage of nimotuzumab and choose other treatment options according to the actual situation of patients.
16082056|NCT02293343|Other|blood profile|
16082057|NCT02293330|Drug|continuous infusion of levobupivacaine|continuous infusion of levobupivacaine 0,125% at 5 ml/h , bolus dose 6 ml, lock out 30 minutes 4 hours limit: 60 ml/h
16082058|NCT02293330|Drug|Intermittent bolus infusion of levobupivacaine|Intermittent bolus of levobupivacaine 0,125%: 0.1 ml /h and 9,8 ml bolus every two hours. Optional patient controlled bolus dose 6 ml, lock out 30 minutes, 4 hours limit: 60 ml/h
16082059|NCT02293317|Biological|M-001|A recombinant epitope based universal vaccine against seasonal and pandemic influenza
16082060|NCT02293317|Drug|TIV|HA based seasonal influenza vaccine, for 2014/15 seson
16082061|NCT02293317|Other|Saline|Placebo
16082062|NCT02293304|Other|Self-etch approach|The adhesive will be vigorously agitated on the entire enamel and dentin surfaces for 20 seconds, according to the manufacturer's recommendations.The brush will be scrubbed on the dentin surface under manual pressure followed by gentle air thinning for five seconds and finally light curing for 10 seconds.
16082063|NCT02293304|Other|Etch-and-rinse approach|After acid etching for 15 seconds, the sound and caries-affected dentin will be kept moist.The adhesive will be vigorously agitated on the entire enamel and dentin surfaces for 20 seconds, according to the manufacturer's recommendations.The brush will be scrubbed on the dentin surface under manual pressure followed by gentle air thinning for five seconds and finally light curing for 10 seconds.
16082064|NCT02293291|Dietary Supplement|Lithium Water|"To empirically test the effects of Lithium water in violence prevention program on rates of violent attitudes and behavioral inclinations in populations whose drinking water supplies contain little or no lithium.
~To utilize an experimental design to establish statistical support for the impact of community habits related variables (protective factors) on violent attitudes and behavioral inclinations among at-risk communities To demonstrate the effect of drinking water variables (protective factors) to existing evidence-based factors (risk factors) that have proven effective in GWI"
16082065|NCT02293278|Behavioral|Physical Activity Intervention|The intervention consists of 2, 3-hour workshops conducted by a master trainer with experience in promoting PA in preschoolers. The workshops focus on the importance of PA and movement skills for preschool-aged children, understanding structured and unstructured play, practical activities related to movement skills, how to overcome barriers in facilitating PA, and using everyday materials to facilitate PA and active play. Each provider in the intervention group is given the Healthy Opportunities for Preschoolers resource training manual, suggested implementation, and a starter kit of equipment. Master Trainers facilitated biweekly PA sessions throughout the intervention. The intervention is based on NASPE (2002) guidelines of not having children sedentary more than 60 mins at a time, having children accumulate 60 mins in structured and unstructured PA (active play) each day at MVPA, as well as 180 mins of total PA as recommended by the Canadian PA Guidelines for preschoolers.
16082066|NCT02293265|Drug|Short Acting Beta Agonist (SABA)|Participants requiring a spirometry measurement will be administered a SABA in a metered dose inhaler (MDI) during the reversibility assessments
16082067|NCT02293252|Device|Remote patient monitoring (Motiva)|interactive bi-directional home telemonitoring system that provides remote monitoring
16082068|NCT02293239|Other|Whole-Body Electromyostimulation (WB-EMS)|WB-EMS training is performed 2x/week for 12 weeks; Stimulation protocol: Frequency of 85 Hz, pulse duration of 0.35 ms, stimulation period of 6 sec, resting period of 4 sec; supervised by certified training instructors/physiotherapists participants perform simple exercises during the stimulation period following a video tutorial
16082069|NCT02293226|Device|CoopDech|Video-laryngoscopy 1
16082070|NCT02293226|Device|CoPilot|video-laryngoscopy 2
16082071|NCT02293226|Device|Intubrite|Video-laryngoscopy 3
16082072|NCT02293226|Device|Vividtrack|video-laryngoscopy 4
16082073|NCT02293213|Behavioral|EMR Referral|EMR referral to California Teratogen Information Services (CTIS) for use of category D or X medication.
16082074|NCT02293213|Behavioral|CTIS Counseling|Counseling from MotherToBaby teratogen information specialist.
16082075|NCT02293213|Behavioral|Baseline Questionnaire|Baseline Questionnaire capturing contraceptive use immediately after counseling with MotherToBaby
16082076|NCT02293213|Behavioral|Contraception Provision Appointment|Appointment with contraception provider to discuss contraception options.
16082077|NCT02293213|Behavioral|3 Month Follow Up Questionnaire|Questionnaire 3 months after CTIS counseling to assess contraception use and plans
16082078|NCT02293213|Behavioral|6 Month Follow Up Questionnaire|Questionnaire 6 months after CTIS counseling to assess contraception use and plans
16082079|NCT02293200|Device|Standard BLS|basic life support without any feedback device
16082080|NCT02293200|Device|TrueCPR|CPR with feedback device
16082081|NCT02293187|Dietary Supplement|vitamin D3|Dose for intervention arm is 800 IU/day for first 4 months. At 4 months, if vitamin D level <70 nmol/L, a second 800 IU capsule will be added to regimen (total of 1600 IU/d) for remainder of study.
16082082|NCT02293187|Other|Placebo|Those in the placebo group will receive 1 capsule for first 4 months. At 4 month visit, one capsule will be added to regimen to be taken throughout the remainder of the study.
16082083|NCT02293174|Device|Topcon TRC-NW400|Retinal Fundus Camera
16082084|NCT02293174|Device|TRC-NW8|Retinal Fundus Camera
16082085|NCT02293174|Device|TRC-NW400|Retinal Fundus Camera
16082086|NCT02293174|Device|Canon-CR2|Retinal Fundus Camera
16082087|NCT02293174|Device|Zeiss Visucam PRO|Retinal Fundus Camera
16082088|NCT02293161|Drug|GSK2618960|GSK2618960 will be provided as 100 mg/mL solution for injection to be administered as single dose IV infusion that has to be diluted at the study site with placebo
16082089|NCT02293161|Drug|Placebo|It is Sodium Chloride Intravenous Infusion
16082090|NCT02293148|Drug|GSK1278863 75 mg|A round, biconvex, white film coated tablet available in two doses (25 and 100 mg)
16082091|NCT02293148|Drug|GSK1278863 500 mg|A round, biconvex, white film coated tablet available in two doses (25 and 100 mg)
16082092|NCT02293148|Drug|Moxifloxacin 400 mg|Oblong, dull red, film-coated, convex tablets with M400 on one side
16082093|NCT02293148|Drug|Placebo matching GSK1278863|A round, biconvex, white film coated tablet as matching placebo for GSK1278863
16082094|NCT02293148|Drug|Placebo matching Moxifloxacin|Capsule shaped white film coated tablet as matching placebo for Moxifloxacin
16082095|NCT02293135|Device|Verum Stendo session on V1 and Phantom Stendo session on V2|On the firt V1 visit, the patient will receive the verum Stendo session ; then on V2 visit ((V1 + 13 days +/- 2), the patient will receive the verum Stendo session On the firt visit, V1 the patient will have a phantom Stendo session (no pressure will be applied)
16082096|NCT02293135|Device|Phantom Stendo session on V1 and Verum Stendo session on V2|On the firt V1 visit, the patient will have a phantom Stendo session (no pressure will be applied) ; then on V2 visit ((V1 + 13 dayx +/- 2), the patient will receive the verum Stendo session
16082097|NCT02293122|Other|Observational|Intervention is observational to two different diagnostic devices for which comparative readings of the corneal endothelium are being measured; the test device- the EM-3000 Specular Microscope against the Konan Robo-pachy F&A Specular Microscope.
16082098|NCT02293109|Drug|carfilzomib|Given IV
16082099|NCT02293109|Drug|cyclophosphamide|Given IV
16082100|NCT02293109|Drug|vincristine sulfate|Given IV
16082101|NCT02293109|Drug|doxorubicin hydrochloride|Given IV
16082102|NCT02293109|Drug|dexamethasone|Given PO
16082103|NCT02293109|Drug|methotrexate|Given IV
16082104|NCT02293109|Drug|cytarabine|Given IV
16082105|NCT02293109|Drug|leucovorin calcium|Given IV or PO
16082106|NCT02293109|Drug|methylprednisolone|Given IV
16082107|NCT02293109|Biological|rituximab|
16082108|NCT02293109|Other|laboratory biomarker analysis|Correlative studies
16082109|NCT02293096|Drug|metoprolol succinate|
16082110|NCT02293096|Genetic|Genotyping|CYP2D6 only clinically pertinent pathway of metoprolol metabolism and polymorphisms have been associated with altered levels of metoprolol. ADRB1 is the drug target and polymorphism in this receptor has been associated with variable drug response. Genotyping will occur after the treatment phase is complete. Thus the investigator, the subject, and the outcomes investigator will be blind to the intervention.
16082111|NCT02293096|Procedure|CYP2D6 Phenotyping|Phenotype can be discordant from what is predicted by genotype due to variability in absorption, hepatic blood flow, drug interaction and drug elimination. These factors can be accounted for by utilizing a phenotyping assay that determines area under the curve of the probe since the probe is affected by the same variables dictating metabolism phenotype of the therapeutic drug. Investigators will be blind to the patient blood pressure outcome for this intervention.
16082112|NCT02293083|Drug|trigger point injection|
16082113|NCT02293070|Other|Delayed Enhanced Cardiac Magnetic Resonance Imaging|Subjects in this study get a Delayed Enhanced Cardiac Magnetic Resonance Imaging 2-6 weeks after they undergo cryoablation for atrial fibrillation. This MRI is compared to the pre-procedure cardiac MRI to determine if it possible to visualize the cryoablation lesions.
16082114|NCT02293070|Procedure|Cryoablation|All subjects in this study undergo a cryoballoon ablation procedure to achieve pulmonary vein isolation for the purposes of treatment of atrial fibrillation
16082115|NCT02293057|Behavioral|VOICES Group|VOICES: A program of self-discovery and empowerment includes four modules: Self (A), Connecting with others (B), Healthy living (C), and the Journey Ahead (D). All sessions are 60 minutes long and include required and optional activities.
16082116|NCT02293057|Behavioral|Girl Health Group|The Girl Health group comparison condition includes adolescent groups matched for time and attention to VOICES groups. Intervention take a psychoeducational/didactic approach and content focuses on a range of health behaviors, including substance use, exercise, nutrition and sleep.
16082117|NCT02293044|Device|Crest® Sensi-Stop™ Strips|
16082118|NCT02293031|Device|"Gene-activated matrix Nucleostim"|"Gene-activated matrix Nucleostim is bone graft substitute consisting of collagen-hydroxyapatite composite scaffold and DNA plasmids with gene encoding vascular endothelial grothw factor (VEGF-A165) in concentration 100-120 ng/mg which is an active substance of gene-therapeutic drug Neovasculgen®."
16082119|NCT02293018|Drug|0.75% (w/w) MTC896 Gel Once Daily|
16082120|NCT02293018|Drug|0.75% (w/w) MTC896 Gel Twice Daily|
16082121|NCT02293018|Drug|1.5% (w/w) MTC896 Gel Once Daily|
16082122|NCT02293005|Drug|Alisertib|50 mg twice a day on Days 1-7 of each 21-day study cycle.
16082123|NCT02292992|Device|Nasal Pillow CPAP|Nasal Pillow CPAP in extubated patients
16082124|NCT02292979|Drug|Doxorubicin|25mg/m2
16082125|NCT02292979|Drug|Bleomycin|10mg/m2
16082126|NCT02292979|Drug|Vinblastine|6mg/m2
16082127|NCT02292979|Drug|Dacarbazine|375mg/m2
16082128|NCT02292979|Drug|Brentuximab Vedotin|1.2 mg/kg
16082129|NCT02292966|Drug|DCV/ASV/BCV|Each participant will each receive daclatasvir (30mg), asunaprevir (200mg) and beclabuvir (75mg) in a fixed-dose combination oral tablet for twice daily administration with food.
16082130|NCT02292953|Other|Serum Prolactin levels|blood samples will be drawn from patients undergoing ICSI to analyse serum prolactin levels
16082131|NCT02292927|Behavioral|Post-intervention arm = Prehabilitation|Introduction of a physical exercise training programme, psychological counselling and smoking cessation advice
16082132|NCT02292914|Procedure|Robot-assisted surgery|Robot-assisted esophagectomy; Robot-assisted subtotal gastrectomy; Robot-assisted pancreatectomy;Robot-assisted rectal resection; Robot-assisted radical cistectomy;Robot-assisted prostatectomy;Robot-assisted Partial Nephrectomy; Robot-assisted hysterectomy;Robot-assisted Resection of malignant tumors of the mouth and orofaringolaringe; Robot-assisted lung lobectomy
16082133|NCT02292914|Procedure|Conventional Surgery|Thoracoscopic Esophagectomy; Open rectal resection and rectal laparoscopy resection; Open radical cistectomy; Open prostatectomy; Open Partial Nephrectomy; Laparoscopic hysterectomy; Laparoscopic lung lobectomy
16082134|NCT02292901|Device|Macintosh laryngoscope|
16082135|NCT02292901|Device|McGrath Mac videolaryngoscope|
16082136|NCT02292888|Other|Passive Leg Raising (PLR) test|Passive Leg Raising (PLR) test
16082137|NCT02292862|Procedure|Lymph node and blood sampling|"By bipolar dissection 1 portal and 1 mesenteric lymph node are removed from the infant.
~Blood (1ml) is taken from mother and infant."
16082138|NCT02292849|Behavioral|Peer to Peer|12 weekly sessions of peer-delivered behavioral activation
16082139|NCT02292849|Other|Standard Mental Health Referral|Standard mental health referral to a community agency
16082140|NCT02292836|Other|Questionnaire testing|Questionnaire testing on rosacea and non-rosacea dermatology outpatients
16082141|NCT02292823|Device|MGuard™ Prime Embolic Protection Stent System|
16082142|NCT02292810|Device|Inspiratory muscle exercise|For inspiratory muscle exercise patients will breathe with a high load of 60% of MIP using a respiratory frequency of 15 breaths min and a prolonged duty cycle (TI/TTOT =0.7) until task failure. The blood flow, conductance and resistance arterial will be measured in the calf using plethysmography device. Arterial blood pressure and heart rate will be monitored continuously at the finger on a beat-by-beat basis by biopac equipment and the glucose levels will be captured by continuous glucose monitoring system.
16082143|NCT02292810|Device|Inspiratory muscle exercise placebo|For inspiratory muscle exercise patients will breathe with a very low load of 2% of MIP using a respiratory frequency of 15 breaths min and a prolonged duty cycle (TI/TTOT =0.7) for 10 minute. The blood flow, conductance and resistance arterial will be measured in the calf using plethysmography device. Arterial blood pressure and heart rate will be monitored continuously at the finger on a beat-by-beat basis by biopac equipment and the glucose levels will be captured by using the continuous glucose monitoring system.
16082144|NCT02292797|Other|Prevalence assessment|Assessment of the prevalence of rosacea in the general population per country using subject questionnaire and dermatologist diagnosis
16082145|NCT02292784|Drug|Retosiban|This is a safety follow-up study of infants and children exposed to retosiban during their mother's participation in a Phase III treatment study for SPTL. Infants enrolled in this study will not be administered any investigational product.
16082146|NCT02292784|Drug|Atosiban|This is a safety follow-up study of infants and children exposed to atosiban comparator during their mother's participation in a Phase III treatment study for SPTL. Infants enrolled in this study will not be administered any investigational product.
16082147|NCT02292784|Drug|Placebo|This is a safety follow-up study of infants and children exposed to matching placebo for retosiban/ atosiban during their mother's participation in a Phase III treatment study for SPTL. Infants enrolled in this study will not be administered any investigational product
16082148|NCT02292771|Drug|Retosiban|Solution for infusion, consisting of a clear colorless solution of retosiban at a concentration of 15 milligram/milliliter (mg/mL) in 56% volume/volume ethanol/acetate buffer concentrate supplied in 5 mL vial containing 75mg retosiban.
16082149|NCT02292771|Drug|Atosiban|Clear, colorless solution for injection in a 0.9-mL vial containing 6.75 mg of atosiban. Clear, colorless concentrate for solution for infusion in a 5-mL vial containing 37.5 mg atosiban.
16082150|NCT02292771|Drug|Placebo matching retosiban|A placebo infusion containing 0.9% sodium chloride (NaCl) matched for retosiban loading (bolus) dose and continuous infusion.
16082151|NCT02292771|Drug|Placebo matching atosiban|A placebo infusion containing 0.9% NaCl matched for the atosiban loading (bolus) dose and continuous infusion.
16082152|NCT02292758|Biological|Bevacizumab|Given IV
16082153|NCT02292758|Biological|Cetuximab|Given IV
16082154|NCT02292758|Drug|Irinotecan|Given IV
16082155|NCT02292758|Other|Laboratory Biomarker Analysis|Correlative studies
16082156|NCT02292758|Other|Placebo|Given IV
16082157|NCT02292745|Radiation|stereotactic radiotherapy|
16082158|NCT02292732|Drug|Trametinib 0.5 mg|Each tablet will contain GSK1120212B equivalent to 0.5 mg of Trametinib. Tablets are yellow, oval, biconvex, film-coated (4.85 x 8.86 millimeter [mm]) to be taken orally and once daily
16082159|NCT02292732|Drug|Trametinib 2 mg|Each tablet will contain GSK1120212B equivalent to 2 mg Trametinib. Tablets are pink, round, biconvex and film-coated tablets (7.5 mm in diameter) to be taken orally and once daily.
16082160|NCT02292732|Drug|ORTHO-NOVUM® tablet 1/35|Each peach tablet will contain 1 mg of NE and 0.035 mg of EE. Other inactive ingredients will include lactose, magnesium stearate and pregelatinized corn starch
16082161|NCT02292732|Drug|Placebo|Each green tablet will contain only inert ingredients: D&C yellow No. 10 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, lactose, magnesium stearate, microcrystalline cellulose, and pregelatinized cornstarch. The tablets are to be taken orally and once daily
16082162|NCT02292719|Drug|OBV/PTV/r|Tablet
16082163|NCT02292719|Drug|Sofosbuvir|Tablet
16082164|NCT02292719|Drug|Ribavirin (RBV)|Tablet
16082165|NCT02292706|Drug|Sofosbuvir|Exposure of interest for participants who received a sofosbuvir-based regimen in a previous Gilead study for chronic hepatitis C virus infection.
16082166|NCT02292693|Device|MIL|Direct laryngoscopy. Laryngoscopy with Miller blade
16082167|NCT02292693|Device|MAC|Direct laryngoscopy. Laryngoscopy with Macintosh blade
16082168|NCT02292693|Device|McCoy|Direct laryngoscopy. Laryngoscopy with McCoy blade
16082169|NCT02292667|Procedure|TAP block|The aim of the Transversus Abdominis Plane (TAP) Block is to deposit local anesthetic in the plane between the internal oblique and the transversus abdominis muscles targeting the spinal nerves in this plane. The local anesthetic used in the ETAP study is Ropivacaine 0.375%. 2 ultrasound-guided injections of 10 ml will be performed on each side of the abdominal wall: 1 subcostal injection and 1 supra-iliac injection.
16082170|NCT02292667|Drug|PCA with Chlorhydrate of Morphine|Doses of 1 mg of Chlorhydrate of Morphine will be delivered intravenously by the Patient Controlled Analgesia (PCA) pump. The PCA pump is a computerized pump which contains a syringe of 1 mg/ml of Chlorhydrate of Morphine as prescribed by the physician in charge of the patient, and connected directly to a patient's intravenous line. Doses of Chlorhydrate of Morphine can be self-administered by the patient as needed by the having the patient press a button.
16082171|NCT02292667|Drug|Acetaminophen|1 g of Acetaminophen will be given intravenously each 6 h during 48 hours after the surgical procedure.
16082172|NCT02292654|Drug|Olipudase alfa|Pharmaceutical form: powder for concentrate for solution for infusion Route of administration: intravenous infusion
16082219|NCT02292303|Dietary Supplement|Zinc references|
16082220|NCT02292290|Drug|Liraglutide|4 week lead-in 0.6mg Liraglutide OD up to 1.2mg OD after 2 weeks if poor response
16084423|NCT02276365|Drug|BI 10773|
16084424|NCT02276365|Drug|Pioglitazone|
16082173|NCT02292641|Procedure|New Radiological Staging Classification system for patients with advanced and recurrent colorectal cancer undergoing pelvic exenterative surgery|Currently there are no validated criteria or guidelines for judging whether advanced primary or recurrent colorectal cancer can be successfully removed and for selecting which patients should undergo this form of more radical surgery as is exenterative surgery. We are proposing that by validating the detailed evaluation of imaging of the tumour distribution within the pelvis using a new radiological staging classification, this will enable clear selection criteria to be established and will improve surgical planning.
16082174|NCT02292628|Drug|Infusion of mesenchymal stem cells from adipose tissue|
16082175|NCT02292628|Other|Infusion of placebo|
16082176|NCT02292615|Other|Medical Imaging|
16082177|NCT02292602|Behavioral|Family-Based Weight Control|Families randomized to the intervention condition will receive a 4-month, 14-session behavioral weight control intervention targeting obesity reduction in preschoolers and caregivers. Within the program, 9 sessions will be group-based and held at WIC and 5 sessions will be individual visits (4 home-based and 1 at a food market where the family shops). The intervention includes teaching behavioral weight loss, child behavior management, and life skills (e.g., budgeting and time management ) via experiential learning to assist families with implementing diet and activity recommendations for pediatric and adult weight management.
16082178|NCT02292589|Device|Frontal Stimulation|The patient will receive anodal tDCS on left dorsolateral prefrontal cortex with an intensity of 1.5 mA for 20 minutes.
16082179|NCT02292589|Device|Temporal Stimulation|The patient will receive anodal tDCS on left temporal cortex with an intensity of 1.5 mA for 20 minutes.
16082180|NCT02292589|Device|Sham Stimulation|The patient will receive anodal tDCS over the occipital area for 30 seconds only and then it will be turned off without the patient's knowledge.
16082181|NCT02292576|Other|Cocoa Pure|Cocoa Pure.
16082182|NCT02292576|Other|Placebo|Placebo.
16082183|NCT02292563|Procedure|Colonoscopist only|Only Colonosopist Observe during Colonoscopy (single observer)
16082184|NCT02292563|Procedure|Experienced Endoscopy Nurse Participation|Experienced Endoscopy Nurse Participation Observation during Colonoscopy (Both endoscopist and endoscopic nurse observe)
16082185|NCT02292550|Drug|Ribociclib|CDK 4/6 inhibitor
16082186|NCT02292550|Drug|Ceritinib|ALK inhibitor
16082187|NCT02292537|Drug|Nusinersen|Administered by intrathecal (IT) lumbar puncture (LP) injection
16082188|NCT02292537|Procedure|Sham procedure|Small needle prick on the lower back at the location where the IT injection is normally made
16082189|NCT02292524|Other|Commercially-available tomato food product|Each of the three tomato food products (juice, soup, sauce) provided 25-35 mg lycopene/day.
16082190|NCT02292511|Behavioral|Square-stepping exercise|In a group setting, an instructor will demonstrate walking patterns on a gridded mat to the participants and the participants must memorize and repeat the patterns on their own. This program has over 200 patterns that increase in difficulty from beginner to advanced. Eighty percent of the group must successfully complete the patterns to move onto the next pattern. Social engagement is encouraged.
16082191|NCT02292498|Device|FLIR ONE|
16082192|NCT02292485|Behavioral|Survey|Physicians complete survey to better understand their readiness to implement lung cancer screening programs in their practice settings. Surveys administered to physicians attending the TAFP education events in Houston, Texas, October 17-19, 2014 and in Dallas, Texas, November 7-9, 2014.
16082193|NCT02292472|Drug|Botulinum Toxin Type A|Inject intramuscularly once in visit 2
16082194|NCT02292472|Drug|Placebos|Inject intramuscularly once in visit 2
16082195|NCT02292459|Drug|Polyethylene Glycol 3350 Powder for Solution (PEG 3350)|
16082196|NCT02292459|Drug|Polyethylene Glycol 4000 Powder for Solution (PEG 4000)|
16082197|NCT02292446|Drug|Ruxolitinib|supplied as 5 mg, 10 mg and 20 mg tablets to be taken orally
16082198|NCT02292433|Drug|PF-04937319 high dose|tablets, 150 mg with breakfast plus 100 mg with lunch, 7 days
16082199|NCT02292433|Drug|PF-04937319 low dose|tablets, 50 mg with breakfast plus 50 mg with lunch, 7 days
16082200|NCT02292433|Drug|Placebo|tablets, breakfast plus lunch, 7 days
16082201|NCT02292407|Device|LigaSure Precise instrument|LigaSure Precise instrument is used during Axillary Lymph Node Dissection Technique: Dead space closure Technique: Omission of postoperative drain
16082202|NCT02292394|Behavioral|Multicomponent Cognitive Behavioral Telephone Intervention|
16082203|NCT02292394|Behavioral|Telephone Intervention Pleasant Activities|
16082204|NCT02292381|Other|Isometric exercise|
16082205|NCT02292368|Behavioral|Questionnaires|At each acupuncture session, 3 questionnaires completed before each session that ask about dry mouth, any other symptoms, and treatment expectations. It should take about 5 minutes total to complete these questionnaires. Participants also complete another brief questionnaire about dry mouth after each session. It should take about 1 minute to complete this questionnaire.
16082206|NCT02292368|Procedure|Acupuncture|Acupuncture treatments given within 3 to 7 days of each other during Weeks 3-5 of regularly scheduled radiotherapy visits. It should take about 20 minutes to complete the acupuncture session each time.
16082207|NCT02292368|Procedure|Electroencephalogram (EEG)|Participants have an EEG at each acupuncture treatment. EEG recorded 5 minutes before acupuncture, during acupuncture, and for 5 minutes after acupuncture. Total visit time will last about 45-60 minutes.
16082208|NCT02292355|Other|Pilates|The intervention group will perform Pilates exercises for 15 weeks with frequency of twice weekly
16082209|NCT02292342|Dietary Supplement|Water|Control
16082210|NCT02292342|Dietary Supplement|Epicatechin 0.1 mg/kg|EC 0.1 mg/kg
16082211|NCT02292342|Dietary Supplement|Epicatechin 0.5 mg/kg|EC 0.5
16082212|NCT02292342|Dietary Supplement|Epicatechin 1.0 mg/kg|EC 1.0
16082213|NCT02292329|Dietary Supplement|Acai puree, frozen blended it with banana|150g of acai fruit, frozen blended it with banana.
16082214|NCT02292329|Dietary Supplement|Control Macronutrient matched|Macronutrient matched control in water and also prepared with banana.
16082215|NCT02292316|Behavioral|gait and cognitive assessments|several tests are given in each domain
16082216|NCT02292316|Biological|blood sample|routine analyses in rheumatology such blood count and 25OH-D
16082217|NCT02292316|Other|osteodensitometry|Looking for osteoporosis
16082218|NCT02292303|Dietary Supplement|zinc-enriched yeast|
16082221|NCT02292290|Drug|Liraglutide|4 week lead-in 0.6mg Liraglutide OD up to 1.2mg after two weeks if poor response.
16082222|NCT02292290|Drug|Sulfonylurea or Pioglitazone|Addition to Metformin
16082223|NCT02292290|Drug|Maintain dual therapy (Sulf/Pio) as comparator to Liraglutide|As per clinical guidelines for prescription
16082224|NCT02292277|Drug|Ticagrelor|Oral loading dose of 180 mg ticagrelor.
16082225|NCT02292251|Behavioral|Device-assisted therapy|
16082226|NCT02292251|Behavioral|Therapy-based occupational therapy|
16082227|NCT02292238|Drug|Benfotiamine|"To test whether increasing brain thiamine by administering 600 mg per day (300 mg/morning and 300 mg/evening) of benfotiamine for one year can slow cognitive decline in these patients as measured with the Alzheimer's Disease Assessment Scale (ADAS-COG).
~To determine whether increasing brain thiamine availability with 600 mg (300 mg/morning and 300 mg/evening) per day of benfotiamine for one year can slow the decline in brain glucose metabolism in these patients as measured with Fluorodeoxyglucose Positron Emission Tomography(FGPET) in the posterior cingulate."
16082228|NCT02292225|Drug|IPI-145 (duvelisib)|25mg and/or 5mg oral capsule
16082229|NCT02292225|Drug|Obinutuzumab|1000mg/40mL single-use vials
16082230|NCT02292212|Device|ViE-21|The subjects will be undergone three times KUF measurement sessions and three times blood sampling sessions during study period.
16082231|NCT02292199|Device|TENS High Frequency|TENS high frequency (100 Hz / 200μs) was applied in bilateral paravertebral region of the T1 segment of the thoracic spine at L2 lumbar spine. The intensity of the current was delivered at sensory-level intensity, adjusted every 5 minutes by the sensory threshold, during the 30 minutes as tolerated by each subject, but without motor contraction or pain reported by the subject.
16082232|NCT02292199|Device|TENS Low Frequency|TENS low frequency (4 Hz / 200μs) was applied in bilateral paravertebral region of the T1 segment of the thoracic spine at L2 lumbar spine. The intensity of the current was delivered at sensory-level intensity, adjusted every 5 minutes by the sensory threshold, during the 30 minutes as tolerated by each subject, but without motor contraction or pain reported by the subject.
16082233|NCT02292199|Device|TENS Placebo|TENS was applied in bilateral paravertebral region of the T1 segment of the thoracic spine at L2 lumbar spine. The placebo group received an active current for 30 seconds, and then gradually decreased for 15 seconds to not pass any current. This approach aims at masking the investigator and subject (RAKEL et al., 2010).
16082234|NCT02292186|Drug|Revusiran (ALN-TTRSC)|
16082235|NCT02292173|Drug|Trametinib|"Dose Escalation:
~Level 1: 1 mg daily. Level 2: 1.5 mg daily. Level 3: 1.5 mg daily. Level 4: 2 mg daily.
~Dose Expansion:
~Maximum Tolerated Dose (MTD)"
16082236|NCT02292173|Drug|Sorafenib|"Dose Escalation:
~Level 1: 200 mg twice daily. Level 2: 200 mg twice daily. Level 3: 400 mg twice daily. Level 4: 400 mg twice daily.
~Dose Expansion:
~Maximum Tolerated Dose (MTD)"
16082237|NCT02292134|Device|earplug and sleep mask|Individual protection against light and noise using earplugs and a sleep mask from 2 hrs to 8 hrs
16082238|NCT02292121|Procedure|Intestinal permeability|5h-intestinal permeability test 10-hour overnight fasting subject who first emptied his bladder drinks a solution of mannitol and lactitol. 2 hours after, the subject drinks 500mL of water in less than 30 minutes. All urine samples are collected during the 5h-test for measurement of lactitol and mannitol.
16082239|NCT02292121|Other|a solution of mannitol and lactitol|
16082240|NCT02292108|Behavioral|dietetic counselling|
16082241|NCT02292108|Behavioral|Hypnosis and self-hypnosis|Erickson's hypnosis and self-hypnosis
16082242|NCT02292095|Procedure|TAPB group|transverse abdominis plane block will be conducted by ultrasound and a single-injection of 20ml 0.75% ropivacaine will be conducted for nerve block at the end of surgery.After surgery,participants in this group will also receive patient controlled intravenous analgesia.
16082243|NCT02292095|Procedure|PCIA group|The formula of patient controlled intravenous analgesia included tramadol 800 mg, flurbiprofenaxetil 100 mg, and dexamethasone 5 mg with saline added up to a volume of 80 ml in total, they received a loading dose of 2 ml followed by an infusion rate of 1 ml/h with bolus of 2 ml, the lock time was set at 15 min
16082244|NCT02292082|Drug|Bupivacaine|
16082245|NCT02292082|Drug|Morphine|
16082246|NCT02292082|Drug|Methylprednisolone|
16082247|NCT02292082|Drug|Cefazolin|
16082248|NCT02292082|Drug|Normal saline|
16082249|NCT02292082|Drug|Midazolam|
16082250|NCT02292082|Drug|Propofol|
16082251|NCT02292082|Drug|Dexamethasone|
16082252|NCT02292082|Device|8 MHz. Chiba needle, 22 G / 4 inches|
16082253|NCT02292069|Drug|Amlodipine besylate/Atorvastatin calcium|Amlodipine besylate/Atorvastatin calcium 10/80 mg
16082254|NCT02292056|Behavioral|1-on-1 counseling|"Precounseling questionnaire collecting demographic information, contraception information, and reasons for choosing contraceptive method
~Precounseling quiz: assess baseline level of knowledge regarding medication safety and contraceptive option.
~Counseling: completed by MotherToBaby counselor about the safety of their medications for use in pregnancy.
~10 minute video entitled The Contraceptive Choice Project: Which Birth Control Method is Right for You? by Washington University in St. Louis.
~Post-Counseling Quiz to assess whether specialized training impacted their understanding of medication safety and contraceptive options.
~Post-Counseling Questionnaire: assess contraceptive plans and satisfaction with counseling"
16082255|NCT02292043|Drug|HTEA|HTEA
16082256|NCT02292030|Drug|HTEA|usually high thoracic epidural anesthesia
16082257|NCT02292017|Device|Embolization of intracranial aneurysm|Cerebral angiogram will be performed, target aneurysm measurements are performed including dome height, width, and depth as well as the neck length. Aneurysm volume will be calculated. During the embolization, framing, filling, and finishing should be done with Target Coils. In the event of aneurysms with a wide neck a Neuroform Stent may be used to ensure the best clinical and angiographic outcome. Immediate post procedure angiography is performed using the same pre-treatment views to assess results and complications.
16082258|NCT02292004|Device|ACL Repair with MIACH Scaffold|Surgical insertion of the MIACH scaffold to promote ACL healing/repair
16082259|NCT02292004|Procedure|Standard ACL Reconstruction|Standard surgical reconstruction of the ACL with autograft hamstring tendon
16082260|NCT02291991|Drug|GX-E2|Investigational drug(GX-E2 or Placebo) will be administered to healthy volunteers by the intravenous route.
16082261|NCT02291991|Drug|GX-E2|Investigational drug(GX-E2 or Placebo) will be administered to healthy volunteers by the intravenous route.
16082262|NCT02291978|Device|ExAblate 2100|The InSightec ExAblate 2100 MRgHIFU system is a non-invasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue and bone.
16082263|NCT02291952|Behavioral|Meal schedule|
16082264|NCT02291939|Procedure|Parotidectomy|Surgical Intervention with the FMwand Surgical System
16082265|NCT02291926|Biological|Human umbilical cord mesenchymal stem cells|A single dose of 2×107 hUC-MSC will be implanted to patients by intra-articular injection, and repeated every month for four times.
16082266|NCT02291913|Drug|Everolimus|
16082267|NCT02291913|Drug|Exemestane|Anti-estrogen therapy
16082268|NCT02291913|Drug|Tamoxifen|Anti-estrogen therapy
16082269|NCT02291913|Drug|Fulvestrant|Anti-estrogen therapy
16082270|NCT02291913|Drug|Anastrozole|Anti-estrogen therapy
16082271|NCT02291913|Drug|Letrozole|Anti-estrogen therapy
16082272|NCT02291913|Drug|Toremifine|Anti-estrogen therapy
16082273|NCT02291900|Procedure|core decompression|retrograd drilling of the avascular talar necrosis, followed by osseous autograft
16082274|NCT02291887|Drug|Ranibizumab|Intravitreal injection of Ranibizumab
16082275|NCT02291887|Drug|Aflibercept|Intravitreal injection of Aflibercept
16082276|NCT02291874|Drug|Ipragliflozin|oral
16082277|NCT02291861|Drug|SD-809|SD-809 tablets dose titrated for 4 weeks until target randomized dose is reached. The dose is maintained for an additional 8 weeks. Tablets were swallowed whole with water and taken with food.
16082278|NCT02291861|Drug|Placebo|Placebo tablets taken twice daily for 12 weeks. Tablets were swallowed whole with water and taken with food.
16082279|NCT02291848|Biological|TAA-specific CTLs|"Each patient will receive 2 infusions at the same dose, 14 days apart, according to the following dosing schedules:
~Dose Level One:
~Day 0: 5 x 10^6 cells/m2 and Day 14: 5 x 10^6 cells/m2
~Dose Level Two:
~Day 0: 1 x 10^7 cells/m2 and Day 14: 1 x 10^7 cells/m2
~Dose Level Three:
~Day 0 2 x 10^7 cells/m2 and Day 14 2 x 10^7 cells/m2
~If patients without measurable disease remain in complete remission or those patients with measurable active disease at the time of infusion have stable disease or a partial response at their 8 week or subsequent evaluations, they are eligible to receive up to 6 additional doses of CTLs at monthly intervals-each of which will consist of the same cell number or less (if there is not enough product) than their second infusion."
16082280|NCT02291822|Drug|Gadobenate Dimeglumine|gadolinium contrast agent
16082281|NCT02291809|Biological|REMUNE|Inoculation of HIV-1 Virus via Vaccination of Whole Killed GP120 Depleted P24 Antigen Vaccine
16082282|NCT02291796|Drug|Bezafibrate|Patients with ST elevation acute myocardial infarction (STEAMI) and with fibrinogen concentration >500 mg/dl at 72 h of evolution, were randomly assigned to bezafibrate 400 mg/day or just conventional therapy
16082283|NCT02291783|Drug|HTL0009936|Single dose
16082284|NCT02291783|Drug|HTL0009936 placebo|Placebo single dose
16082285|NCT02291770|Biological|Mesenchymal Stromal Cells|Mesenchymal stem cell(MSC). Patients with newly diagnosed cGvHD: prednisone 1mg/kg + cyclosporine or tacrolimus and MSC 2×1,000,000 MSC/kg, IV twice a week for the first two weeks and weekly for the following two weeks(6 doses totally).
16082286|NCT02291757|Dietary Supplement|NEM brand eggshell membrane|NEM 500 mg, once daily, p.o.
16082287|NCT02291757|Dietary Supplement|Placebo|Placebo, 500 mg, once daily, p.o.
16082288|NCT02291744|Procedure|resection of primary lesion|Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle, and resection of primary lesion with metastatic colon cancer
16082289|NCT02291744|Drug|XELOX|Oxaliplatin 130mg/m2 ivgtt d1 and capecitabine 1000mg/m2,bid,po,d1-d14,every three weeks for a cycle,
16082290|NCT02291731|Drug|Continuous use of topical autologous serum|Silicone-hydrogel SCLs combined with 20% (v/v) autologous serum eye drops were used until complete re-epithelialization. SCLs were removed after total re-epithelialization and patients were subsequently randomized divided into two groups: (1) with and (2) without continuous use of topical autologous serum for an additional 2 weeks after SCLs removal.
16082291|NCT02291718|Drug|Isovue|iodine contrast
16082292|NCT02291705|Procedure|rectus sheath block|ultrasound-guided rectus sheath block with 0.25% 0.2 ml/kg levobupivacaine
16082293|NCT02291705|Drug|Tramadol|tramadol 1 mg/kg iv
16082294|NCT02291692|Procedure|paravertebral blockade|ultrasound guided thoracic paravertebral block with 0.5 ml/kg bupivacaine %0.5
16082295|NCT02291679|Drug|Linaclotide|
16082296|NCT02291679|Drug|Matching Placebo|
16082297|NCT02291666|Drug|CRCHUM-MT cocktail|
16082298|NCT02291653|Device|McGrath|video-laryngoscopy
16082299|NCT02291653|Device|MIL|direct-laryngoscopy
16082300|NCT02291640|Device|MIL|direct laryngoscopy
16082301|NCT02291640|Device|CoPilot|video laryngoscopy
16082302|NCT02291627|Device|MAC|direct laryngoscopy
16082303|NCT02291627|Device|Coopdech|Video laryngoscopy
16082304|NCT02291627|Device|AirTraq|optical laryngoscopy
16082305|NCT02291614|Drug|AMG 211|continuous intravenous infusion (cIV) infusion in cycles from 7 to 28 days
16082306|NCT02291601|Drug|Chlorhexidine Gluconate|comparison with other CHG products
16082307|NCT02291601|Other|Vehicle|Excipients of CHG product only.
16082308|NCT02291601|Drug|DynaHex-2|2% CHG solution
16082309|NCT02291588|Drug|AMG 811|A single dose of AMG 811 or placebo will be adminstered.
16082310|NCT02291588|Drug|Placebo|contains no active drug
16082311|NCT02291575|Other|Training|(please see Arm Description)
16082312|NCT02291575|Other|Control|This group will not receive any training from the Liver Foundation; they will simply be evaluated at baseline and endline.
16082313|NCT02291562|Drug|Tetrahydrocannabinol|10 mg Tetrahydrocannabinol (capsule, once) oral intake
16082314|NCT02291562|Drug|Cannabidiol|600 mg Cannabidiol (capsule, once) oral intake
16082315|NCT02291562|Drug|placebo|placebo (capsule, once) oral intake
16082316|NCT02291549|Drug|S8 Sinus Implant|In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
16082317|NCT02291549|Drug|Mometasone furoate nasal spray|Mometasone furoate nasal spray (200mcg) once daily
16082318|NCT02291549|Procedure|Sham|In-office bilateral sham procedure, consisting of advancement of a delivery system with the S8 Sinus Implant into the ethmoid sinuses followed by removal without deployment.
16084425|NCT02276352|Drug|Treatment 1|
16082322|NCT02291523|Biological|Fecal Microbial Transplant|Fecal Transplant via Colonoscopy.
16082323|NCT02291510|Drug|Met DR|metformin delayed-release tablets
16082324|NCT02291510|Drug|Met XR|metformin extended-release tablets
16082325|NCT02291510|Drug|Met IR|metformin immediate-release tablets
16082326|NCT02291484|Device|Cardiac CT scan|CT-guided management
16082327|NCT02291471|Drug|T0001，10mg|
16082328|NCT02291471|Drug|T0001，20mg|
16082329|NCT02291471|Drug|T0001，35mg|
16082330|NCT02291471|Drug|T0001，50mg|
16082331|NCT02291471|Drug|T0001，65mg|
16082332|NCT02291471|Drug|T0001，75mg|
16082333|NCT02291458|Drug|L-arginine|9 gram L-arginine / day for 6 weeks
16082334|NCT02291458|Drug|Placebo|9 gram placebo / day for 6 weeks
16082335|NCT02291445|Drug|Menthae piperitae aetheroleum/peppermint oil (enteric coated capsule)|Peppermint oil capsule available as an over the counter prescription drug on the Dutch market.
16082336|NCT02291445|Drug|Menthae piperitae aetheroleum/peppermint oil (colon-targeted-delivery capsule)|Peppermint oil capsule with a coating developed according to the ColoPulse® technology, ensuring a pulsatile and therefore slower release in a lower part of the intestinal tract compared to Tempocol, namely in the (ileo-)colonic region.
16082338|NCT02291419|Drug|ticagrelor|ticagrelor 90 mg bid
16082339|NCT02291419|Drug|aspirin|aspirin 81 mg daily
16082340|NCT02291406|Procedure|Abdominal hysterectomy|Standard extrafascial abdominal total hysterectomy through a low transverse abdominal wall incision.
16082341|NCT02291406|Procedure|Robot assisted laparoscopic hysterectomy|Robotic assisted total laparoscopic hysterectomy.
16082342|NCT02291393|Device|80 lead ECG|
16082343|NCT02291380|Drug|Botulinum Toxin Type A for Injection|In these studies ,patients received a minimum intramuscular (IM) dose of 155 U of Botulinum Toxin Type A（HengLi®）administered to 31 injection sites across 7 head and neck muscles using a fixed-site, fixed-dose injection paradigm (each injection was 5 U in 0.1 mL). In addition, up to 40 U Botulinum Toxin Type A,administered IM to 8 additional injection sites across 3 head and neck muscles, was allowed, using a follow-the-pain approach. Thus, the minimum dose was 155 U and the maximum dose was 195 U. In the core phase, two doses of HengLi® will be injected.In the extension phase, three doses of HengLi® will be injected.
16082344|NCT02291380|Drug|Placebo|In these studies, patients received placebo administered to 31 injection sites across 7 head and neck muscles using a fixed-site, fixed-dose injection paradigm (each injection was 0.1 mL). In addition, up to 0.8 mL placebo, administered IM to 8 additional injection sites across 3 head and neck muscles, was allowed, using a follow-the-pain approach. In the core phase, two doses of placebo will be injected.
16082345|NCT02291367|Drug|Duloxetine|Duloxetine Delayed-Release Capsules 60 mg
16082346|NCT02291367|Drug|Cymbalta®|60 mg capsule of Eli Lilly and Company
16082347|NCT02291354|Drug|Pectin|Patients allocated to experiment group will receive 12 g pectin each day for 12 weeks.
16082348|NCT02291354|Other|Placebo|Patients allocated to experiment group will receive 12 g maltodextrin each day for 12 weeks.
16082349|NCT02291354|Procedure|Fecal microbiota transplantation (FMT)|Standardized Frozen Fecal Microbiota will be infused via nasointestinal tube.
16082350|NCT02291341|Drug|Duloxetine|Duloxetine Delayed-Release Capsules 60 mg
16082351|NCT02291341|Drug|Cymbalta®|60 mg capsule of Eli Lilly and Company
16082352|NCT02291328|Other|High Brassica|Participants consume a minimum of one portion of a Brassica food (84g frozen broccoli, 84g frozen cauliflower, or 300g frozen broccoli and sweet potato soup) each day for 14 consecutive days at their homes.
16082353|NCT02291328|Other|Low Brassica|Participants consume one portion of a Brassica vegetable (84g frozen broccoli, or 84g frozen cauliflower) each week for two weeks at their homes.
16082354|NCT02291302|Other|integrated pest management|integrated pest management and environmental strategy
16082355|NCT02291302|Other|air purifier|air purifiers
16082356|NCT02291302|Other|No intervention (control)|no integrated pest management and sham air purifier
16082357|NCT02291289|Drug|Cetuximab|500 mg/m^2 via IV infusion on Day 1 of every 2-week cycle
16082358|NCT02291289|Drug|FOLFOX induction regimen|Administered per the Investigator's discretion in accordance with locally approved prescribing information.
16082359|NCT02291289|Drug|Fluoropyrimidine (5-FU/LV or capecitabine)|Per Investigator's discretion: 1600-2400 mg/m^2 administered via 46-hour IV infusion on Day 1 of every 2-week cycle and LV 400 mg/m^2 administered via a 2-hour infusion on Day 1 every 2 weeks or 1000 mg/m^2 twice-daily capecitabine (BID) by mouth given days 1-14 every 2 weeks. The chosen fluoropyrimidine should be administered in accordance with local prescribing information.
16082360|NCT02291289|Drug|Atezolizumab|800 mg atezolizumab via 60-minute IV infusion on Day 1 of every 2-week cycle, or a fixed dose of 840 mg
16082361|NCT02291289|Drug|Vemurafenib|960 mg vermurafenib BID by mouth
16082362|NCT02291289|Drug|Bevacizumab|5 mg/kg bevacizumab via 15-30 minute IV infusion on Day 1 of every 2-week cycle per local prescribing information
16082363|NCT02291289|Drug|Trastuzumab|Initial loading dose of 8 mg/kg followed by 6 mg/kg for subsequent doses by IV infusion on Day 1 of every 3-week treatment cycle
16082364|NCT02291289|Drug|Pertuzumab|Initial fixed loading dose of 840 mg followed by 420 mg for subsequent doses by IV infusion on Day 1 of each 3-week treatment cycle
16082365|NCT02291289|Drug|Cobimetinib|60 mg orally once daily for 3 weeks followed by a 1-week treatment break
16082366|NCT02291289|Drug|5-FU/LV|1600-2400 mg/m^2 5-FU via 46-hour IV infusion in combination with 400 mg/m^2 LV via 2-hour infusion on Day 1 of every 2-week cycle until disease progression per the Investigator's assessment using modified Response Evaluation Criteria in Solid Tumors or death from any cause, whichever occurs first.
16082367|NCT02291263|Biological|bOPV/IPV (6 weeks)|bOPV at 6, 10 and 14 weeks of age IPV at 6 weeks of age
16082368|NCT02291263|Biological|bOPV/IPV (14 weeks)|bOPV at 6, 10 and 14 weeks of age IPV at 14 weeks of age
16082369|NCT02291263|Biological|bOPV/IPV (6 & 14 weeks)|bOPV at 6, 10 and 14 weeks of age IPV at 6 and14 weeks of age
16082392|NCT02291094|Drug|Remifentanil|Patients in remifentanil group received an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous remifentanil infusion of 0,1 mcg/kg/min.
16084426|NCT02276352|Drug|Treatment 2|
16082370|NCT02291250|Dietary Supplement|Blackcurrants with polycal OGTT|"Sixteen overweight/obese volunteers from the Aberdeen area will be recruited into a randomised controlled study. Volunteers will be randomised into four groups matched for BMI and age and given 200 grams of blackcurrants (which contain anthocyanins) or greencurrants (which naturally contain no anthocyanins), followed by an OGTT.
~The consumption of the currants will be followed by an oral glucose tolerance test (OGTT) with Polycal (complex carbohydrate) or glucose (simple carbohydrate) as the carbohydrate load.
~The equivalent carbohydrate load will be standardised across the groups"
16082371|NCT02291250|Dietary Supplement|Greencurrants with polycal OGTT|"Sixteen overweight/obese volunteers from the Aberdeen area will be recruited into a randomised controlled study. Volunteers will be randomised into four groups matched for BMI and age and given 200 grams of blackcurrants (which contain anthocyanins) or greencurrants (which naturally contain no anthocyanins), followed by an OGTT.
~The consumption of the currants will be followed by an oral glucose tolerance test (OGTT) with Polycal (complex carbohydrate) or glucose (simple carbohydrate) as the carbohydrate load.
~The equivalent carbohydrate load will be standardised across the groups"
16082372|NCT02291250|Dietary Supplement|Blackcurrants with glucose OGTT|"Sixteen overweight/obese volunteers from the Aberdeen area will be recruited into a randomised controlled study. Volunteers will be randomised into four groups matched for BMI and age and given 200 grams of blackcurrants (which contain anthocyanins) or greencurrants (which naturally contain no anthocyanins), followed by an OGTT.
~The consumption of the currants will be followed by an oral glucose tolerance test (OGTT) with Polycal (complex carbohydrate) or glucose (simple carbohydrate) as the carbohydrate load.
~The equivalent carbohydrate load will be standardised across the groups"
16082373|NCT02291250|Dietary Supplement|Sugar matched water with polycal OGTT|"Sixteen overweight/obese volunteers from the Aberdeen area will be recruited into a randomised controlled study. Volunteers will be randomised into four groups matched for BMI and age and given 200 grams of blackcurrants (which contain anthocyanins) or greencurrants (which naturally contain no anthocyanins), followed by an OGTT.
~The consumption of the currants will be followed by an oral glucose tolerance test (OGTT) with Polycal (complex carbohydrate) or glucose (simple carbohydrate) as the carbohydrate load.
~The equivalent carbohydrate load will be standardised across the groups"
16082374|NCT02291237|Drug|Eleclazine|Tablet (s) administered orally once daily
16082375|NCT02291237|Drug|Placebo|Placebo to match eleclazine administered orally once daily
16082376|NCT02291224|Behavioral|Interactive multimedia platform|An interactive platform that includes video vignettes of young women who are choosing dual protection strategies (based on a synthesis of focus group data from members of the TSC patient population), as well as true/false questions to build knowledge about dual protection and dispel common myths about contraceptive strategies. There will also be reflection questions that encourage participants to consider values and priorities in their own lives that may influence their dual protection strategy selection.
16082377|NCT02291224|Behavioral|Intervention arm counseling|Counseling for the intervention group will follow carefully developed guides and incorporate the participants' answers to the reflection questions in the interactive multi-media component. This counseling has a set structure (set forth in separate counseling guides for health care providers and nurse educators), incorporates motivational interviewing techniques, includes multiple opportunities for role play, and is designed to be patient-centered.
16082378|NCT02291224|Behavioral|Standard of care counseling|Standard of care counseling is provided by health care providers and health educators at TSC. It incorporates extensive counseling on methods to prevent both unintended pregnancy and sexually transmitted infections, however the structure of the counseling and techniques used are dependent on the standard practice of each provider or educator. This counseling does not incorporate answers to reflection questions from the multi-media platform because control arm participants will not view this content.
16082379|NCT02291211|Drug|S-1 plus cisplatin HIPEC|Using cisplatin in HIPEC plus oral S-1
16082380|NCT02291198|Device|NK Vue: NK cell activity in stimulated whole blood|One mL of blood is collected from each subject, on the day of colonoscopy, using NK Vue Promoca Tubes blood collection tubes containing a proprietary stimulating cytokine. After incubation, NK cell activity is measured in the collected plasma using an ELISA.
16082381|NCT02291172|Behavioral|Intervention JEP|A blend of JASP-EMT using SGDs with parent training intervention with the addition of individualized DTT to teach receptive language, imitation, and joint attention when children lack these skills at entry.
16082382|NCT02291159|Device|DNHS ® (Dry Needling for Hypertonia and Spasticity)|Dry needling of Myofascial Trigger Points. 2 sessions, one per week, in biceps brachii, brachialis, flexor digitorum superficialis nad profundus, adductor pollicis and first dorsal interossei
16082383|NCT02291159|Device|Sham Dry Needling|Sham dry needling of Myofascial Trigger Points. 2 sessions, one per week, in biceps brachii, brachialis, flexor digitorum superficialis nad profundus, adductor pollicis and first dorsal interossei
16082384|NCT02291146|Behavioral|LA Sprouts intervention|see arm 1 description
16082385|NCT02291133|Procedure|Electrochemotherapy|Exploration, anesthesia, adhesiolysis, mobilization of liver, intra-operative US or CT, bleomycin administration, electroporation
16082386|NCT02291133|Device|Cliniporator Vitae®|"Positioning of electrodes, 8-28 min after administration of bleomycin application of electric pulses (8 pulses, duration 100 microseconds, frequency 8 Hz with amplitude adequate to cover the whole treated lesion with electric field necessary for reversible plasma membrane permeabilization), removal of electrodes.
~The maximum duration of procedure is 90 minutes, after liver mobilization."
16082387|NCT02291133|Drug|Bleomycin PHC 15 e. (United States Pharmacopeia - USP)|Intravenous in bolus administration of bleomycin (15 mg/m2)
16082388|NCT02291120|Procedure|Pulpotomy|
16082389|NCT02291107|Device|Lokomat (Hocoma, Zurich, Switzerland)|Patients allocated to the Experimental group performed a Robotic Assisted Gait Training by means of the Lokomat. The Lokomat is robotic device set up as an exoskeleton on the lower limbs of the patient. The system uses a dynamic body weight-support system to support he participant above a motorized treadmill synchronized with the Lokomat.
16082390|NCT02291107|Other|Conventional Physiotherapy|Patients allocated to the Control Group performed a general exercise program and a conventional gait training. The same trained therapist treated all the patients in this group and standardized the duration of each part of the treatment.
16082391|NCT02291094|Drug|Lidocaine|Patients in intravenous lidocaine group received an intravenous bolus injection of 2 mg/kg lidocaine followed by a continuous lidocaine infusion of 3 mg/kg/hr.
16084427|NCT02276352|Drug|Treatment 3|
16082393|NCT02291081|Other|Comprehensive non invasive cardiovascular examination|"Comprehensive non invasive cardiovascular examination
~Anamnesis with the participants
~File recherche,Physical examination
~Documentation of the cardiovascular and antiretroviral medical therapy
~Electrocardiogram
~Transthoracic echocardiography
~Exercise electrocardiogram
~Exercise Montreal Cognitive Assessment test
~Exercise the Grooved Pegboard test
~Blood collection
~Questionnaire to quality of life and health economics"
16082394|NCT02291068|Behavioral|psychotherapy treatment|3 months long (12 sessions) dynamic psychotherapy. The dynamic psychotherapeutic technique which will be applied in the current research is derived from Malan's focused, brief psychodynamic psychotherapy (Malan 1976) and from the literature specifying psychodynamic psychotherapies distinctive techniques (Shedler 2010). The principle of this treatment is a time limited intervention in which the primary objective is to enhance the patient's insights regarding repetitive conflicts. As psychodynamic psychotherapy is suitable for all kinds of adjustment disorders, no special adjustment in the course of therapy was made for the different subtypes (Cabaniss et al. 2011).
16082395|NCT02291055|Drug|ADXS11-001|
16082396|NCT02291055|Drug|Medi4736|
16082397|NCT02291042|Drug|B+O Suppository|
16082398|NCT02291029|Drug|CFZ533 active - Cohort 1|multiple doses of CFZ533 s.c. injection
16082399|NCT02291029|Drug|CFZ533 placebo- Cohort 1|multiple doses of placebo s.c. injection
16082400|NCT02291029|Drug|CFZ533 active - Cohort 2|multiple doses of CFZ533 intravenous infusion
16082401|NCT02291029|Drug|CFZ533 placebo - Cohort 2|multiple doses of placebo intravenous infusion
16082402|NCT02291029|Drug|CFZ533 active -Cohort 3|multiple doses of CFZ533 s.c. injection
16082403|NCT02291029|Drug|CFZ533 active - Cohort 3|Single dose of CFZ533 i.v. infusion and multiple doses of CFZ533 s.c. injection
16082404|NCT02291016|Drug|Formoterol|Comparison of dosage administered via a nebulizer versus dosage administered via a dry powder inhaler. 12 µg Formoterol with the dry powder inhaler and 20 µg (solution form) of Formoterol with the nebulizer. Patients will receive formoterol and placebo at both study visit #1 and visit #2.
16082405|NCT02291016|Other|Placebo|Comparison of drug administered via a nebulizer versus a dry powder inhaler. The placebo used will be sterile, preservative free, normal saline for inhalation for the nebulizer and a matched capsule without active drug for the dry powder inhaler. All patients will receive 2 ml of normal saline with the nebulizer to match the volume of nebulized formoterol solution. Patients will receive formoterol and placebo at both study visit #1 and visit #2.
16082406|NCT02290990|Behavioral|"Imaginative Distention technique"|ID is an Imaginative relaxation technique which combines physical and mental relaxation. ID technique reaches physical relaxation through planned alternated movements taken from Jacobson PMRT which consist of specific muscle contractions and subsequent relaxations, with a precise temporal scanning. Psychological relaxation is achieved thanks to mental imagery (motor imagery, body scan, imagination).
16082407|NCT02290977|Radiation|Scheduled interval TACE - RT|RT will be administered at 2 weeks after TACE in HCC combined PVTT
16082408|NCT02290964|Procedure|ANH|After general anesthesia is applied, blood was taken through the cubital vein and collected into standard blood bags containing CPDA anti-coagulant. The blood obtained is then stored at temperature of 23 - 25 Celsius degree and given back to patients in the operating room after the bleeding stopped and as soon as there are indications of transfusion.
16082410|NCT02290938|Behavioral|MICUNAY|MICUNAY is a three session workshop focused on discussions about how to make healthy choices using motivational interviewing, and providing a cultural activity.
16082411|NCT02290938|Other|Community Wellness Gathering|a monthly gathering focused on making healthy choices and learning about Native American culture
16082412|NCT02290925|Drug|Kothala Himbutu Biscuit|Kothala Himbutu biscuit (containing Salacia reticulata extract) as a snack. This herb has been used by traditional physicians to control blood sugar.
16082413|NCT02290925|Dietary Supplement|Placebo Biscuit|Placebo biscuit without the herbal extract of Kothala Himbutu (Salacia reticulate)
16082414|NCT02290912|Behavioral|Health education program|"The intervention is a health education program including: informational website, experiential classes, custom smart phone or smart table application, wearable activity monitor, and informal coaching by student researchers to provide moral support for lifestyle behavioral change goals. Participants are not placed on any specific behavioral regimen but instead are encouraged to adopt healthier lifestyle behaviors per the evidence-based health education program, and to attend the experiential classes cafeteria style (i.e. based on their individual preferences)."
16082415|NCT02290886|Other|Intravenous administration of placebo|
16082416|NCT02290886|Drug|Intravenous administration of 1 million of MSC|
16082417|NCT02290886|Drug|Intravenous administration of 2 million of MSC|
16082418|NCT02290886|Drug|Intravenous administration of 4 million of MSC|
16082419|NCT02290873|Drug|Remimazolam|For induction and maintenance of sedation
16082420|NCT02290873|Drug|Midazolam|For induction of maintenance and sedation
16082421|NCT02290873|Drug|Placebo|Inactive control arm
16082422|NCT02290860|Procedure|Type 2 diabetes diagnosis test|Participants will perform type 2 diabetes diagnosis test the day of hospital discharge after delivery and the same test around 8 weeks later.
16082423|NCT02290847|Behavioral|Cognitive Processing Therapy (cognitive only version; CPT-C)|CPT is a cognitive behavioral treatment for PTSD consisting of 12 one-hour sessions (Resick, Monson, & Chard, 2008; Resick & Schnicke, 1993). CPT is delivered in three phases: education, processing, and challenging. The manualized treatment focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world.
16082424|NCT02290834|Other|Cognitive, functional and subjective assessments|Cognitive and functional assessments
16082425|NCT02290834|Device|MRI|Magnetic Resonance Imaging (MRI) Scan
16082426|NCT02290834|Radiation|PET Scan|Positron Emission Tomography (PET) Scan
16082427|NCT02290821|Drug|placebo|
16082428|NCT02290821|Drug|Placebos|
16082429|NCT02290808|Behavioral|Theory-based group|Workbooks and mini-counselling sessions will be provided to participants in this group.
16082430|NCT02290795|Other|OCT imaging/HRT imaging|Standard follow up protocol with Optical coherence Tomography (OCT) imaging and Heidelberg Retinal Tomograph (HRT) imaging for glaucoma patients and patients scheduled for Ocriplasmin treatment In case of healthy controls the same investigations will be performed.
16082431|NCT02290782|Radiation|Intraoperative radiotherapy (IORT)|"The surgeon and radiation oncologist should choose the largest possible suitable applicator in order to ensure that the highest possible dose is delivered to the tumor bed tissue. A dose of 20 Gy at the surface of the applicator (in water) is prescribed by the radiation oncologist and delivered to the breast tissue. This takes approximately 20-50 minutes, depending on the size of the applicator.
~To minimize radiation dependent side effects the skin-applicator surface distance should be more than 5 mm."
16082432|NCT02290769|Device|Short guide wire rapid exchange|Use of short guide wire rapid exchange to guide the cannulation during primary ERCP
16082433|NCT02290769|Device|Long guide wire|Use of long wire to guide the cannulation during primary ERCP
16082434|NCT02290756|Behavioral|Parenting Program|The parenting program is an early childhood stimulation program aimed at newborns from their neonatal period till infancy. The implementation of the parenting program will be conducted through the link workers and parents of the newborns.
16082435|NCT02290756|Behavioral|Low cost evidence based toolkit|"The aim of providing the toolkit is to ensure that all pregnant women in the project are provided the requisite care needed from the antenatal period till delivery to limit complications and insults (both mother and especially the neonate) that can occur during pregnancy, delivery and post partum in both the mother and child. The contents of the toolkit will include:
~Clean delivery kit, aspiration bulb, bag and mask, Chlorhexidine, Misoprostol, Nutritional supplements (Iron and folic acid, awareness about breastfeeding) and IEC materials
~Trainings for Birth Attendants and Link workers on aspiration and hypothermia management techniques, use of bag and mask APGAR (also to parents), cord care, basic pregnancy and newborn care information"
16082436|NCT02290743|Other|Kinesio tape|Application of one Kinesio tape with 0-30 % tension over the muscle fibers of the quadriceps femoris in a stretched position. The tape can be divided into several tails to cover the whole muscle from origin to insertion.
16082437|NCT02290730|Other|Kinesio tape|Application of one Kinesio tape with 0-30 % tension over the muscle fibers of the lower trapezius in a stretched position. The tape can be divided into one, two or three tails to cover the whole muscle from origin to insertion
16082438|NCT02290717|Device|Fractional CO2 laser|
16082439|NCT02290717|Other|NB-UVB therapy|NB-UVB therapy (according to the standard treatment protocol of the SNIP, which the patient is already been treated with) will be continued for both treated and control sites during 6 months.
16082440|NCT02290717|Drug|Fluticasone Propionate Cream 0.05%|4 times a week (standard IPD protocol)
16082441|NCT02290691|Biological|Influenza Vaccine|Influenza Vaccine
16082442|NCT02290678|Behavioral|Adventure-based Programming|
16082443|NCT02290665|Other|Thermosensitive gel rectal formulation|
16082444|NCT02290665|Other|Saline enema|
16082445|NCT02290652|Other|Prospective - Factors affecting sexual function pre-THR|"A prospective assessment of factors affecting sexual function in patients whom are awaiting a total hip replacement.
~Patients will carry out a prospective 23 question questionnaire: 'Arthroplasty & Sexual Function Questionnaire (ASFQ) - Pre-operative' with validated questionnaire Female Sexual Function Index (FSFI), before their operation.
~Then at 6 months and 12 months post-operatively they will fill out a retrospective 30 question questionnaire: 'Arthroplasty & Sexual Function Questionnaire (ASFQ) - Post-operative', again with FSFI."
16082446|NCT02290652|Other|Retrospective- Factors affecting sexual function post-THR|"A retrospective assessment of factors affecting sexual function in patients whom have undergone a total hip replacement (THR) in the preceding year.
~Patients will carry out a retrospective 30 question questionnaire: 'Arthroplasty & Sexual Function Questionnaire (ASFQ) - Post-operative' with validated questionnaire Female Sexual Function Index (FSFI), at 6 months and/or 12 months (wherever possible).
~Maximum retrospective collection of data 12 months."
16082447|NCT02290639|Behavioral|Brief Cognitive Behavioral Treatment|Cognitive-behavioral therapy (CBT) protocol designed specifically for use by behavioral health consultants (BHC) working in an integrated primary care setting. The treatment will be provided by a BHC in four 30-minute appointments scheduled approximately once a week in primary care over a one month period. Treatment content was largely drawn from a Prolonged Exposure model, but also includes elements of Cognitive Processing Therapy.
16082448|NCT02290639|Behavioral|Minimal Contact|Participants assigned to minimal contact (MC) will be asked to not work with another therapist or seek additional treatment for trauma-related difficulties during the 6-week MC period. They will be called once per week by the Behavioral Health Consultant (BHC) in order to monitor their status and to provide support as needed. The calls will be limited to 5-10 minutes.
16082449|NCT02290626|Drug|Elmental diet|elemental diet is administered using PEG.
16082450|NCT02290626|Drug|Semi-solid diet|Semi-solid diet is administered using PEG.
16082451|NCT02290613|Drug|Ambrisentan|"Titration:
~As common practice of the clinic, the patient will adapt the dose from 5 mg to 10 mg after 1 to 4 weeks according to tolerability and after consultation (by phone or personally) with one of the investigators.
~Additionally, at each study visit the investigator needs to decide, based on the patient's well-being, patients´ assessment, safety parameters, and tolerance of ambrisentan, if the study medication should be modified. The respective decision (increase, maintain or decrease dose) must be documented.
~Maximum dose allowed: not to exceed 10 mg/day.
~Administration:
~Ambrisentan and placebo will be administered orally with or without food intake."
16082452|NCT02290613|Drug|Placebo|Placebo tablet (one to two tablets corresponding to one to two verum tablets)
16082453|NCT02290600|Device|Continuous Glucose Monitor|CGM sensor calibration individualization
16082454|NCT02290587|Other|Brain MRI - Clinical and cognitive evaluation|"Neuropsychological evaluation :
~Questionnaire for depression and anxiety
~Evaluation of executive functions
~Evaluation of attention, information processing speed, verbal memory and working memory
~Theory of mind evaluation
~Clinical Evaluation
~MRI Evaluation :
~morphological MRI
~functional MRI with two tasks of theory of mind : eyes test and test of attribution of intention"
16082455|NCT02290587|Device|MRI|
16082456|NCT02290574|Radiation|Hyperthermia with concurrent chemo-radiation therapy|
16082457|NCT02290561|Procedure|SmartTarget Therapy|MRI to Ultrasound fusion directed HIFU
16082458|NCT02290561|Device|MRI|
16082459|NCT02290561|Device|high intensity focused ultrasound (HIFU)|
16082460|NCT02290548|Device|high flow nasal cannula|High flow nasal cannula used in postextubation patients
16082486|NCT02290340|Drug|MEDI8897 10 mg|Participants will receive a single dose of MEDI8897 10 milligram (mg) intramuscularly.
16082461|NCT02290535|Procedure|patients|The 16-electrode belt will be applied to patient's chest. Following vital signs will be recorded: respiratory rate at rest breathing, heart rate, transcutaneous oxygen saturation. Then impulse oscillometry (IOS) will be performed in a sitting position. After that, subjects with cooperation willingness will get a body plethysmography. A spirometry / forced breathing maneuvers will be performed. All patients will receive 2 strokes salbutamol inhaler for bronchospasmolysis. Please note that inhalation of salbutamol is not study related. It is used in the clinical routine to examine the reversibility of the bronchial obstruction in patients with obstructive lung disease in course of the lung function test. Ten minutes later measurements described above will be repeated.
16082462|NCT02290535|Procedure|probands|Probands will receive the same treatment as patients, but without bronchospasmolysis.
16082463|NCT02290522|Procedure|Tumor biopsy|Biopsy of lesion for molecular characterization
16082464|NCT02290509|Biological|Flublok Quadrivalent|Intramuscular injection of study vaccine
16082465|NCT02290509|Biological|Inactivated Influenza Vaccine (IIV4)|Intramuscular injection of study vaccine
16082466|NCT02290496|Behavioral|CBT for Insomnia (CBT-I)|Cognitive behavior therapy for insomnia (CBT-I) comprising stimulus control, sleep restriction, and sleep-focused cognitive therapy. The CBT-I consists of in-person sessions and homework assignments and includes stimulus control and sleep restriction to regularize the sleep-wake cycle; cognitive therapy to address dysfunctional sleep beliefs and bedtime rumination; motivational interviewing to help youth make important health changes; and parental involvement. In addition, participants will continue treatment as usual (TAU) SSRI antidepressants delivered by a usual care provider.
16082467|NCT02290496|Behavioral|Sleep Hygiene (SH)|Attention placebo control focusing on sleep hygiene, consisting of in-person sessions and homework assignments. The sleep hygiene sessions address sleep-related topics such as limiting pre-sleep caffeine intake, sleep-promoting activities, and the impacts of insufficient sleep. In addition, participants will continue treatment as usual (TAU) SSRI antidepressants delivered by a usual care provider.
16082468|NCT02290470|Drug|Olanzapine|"Drug: Olanzapine 10 mg oral
~Drug: Chemotherapy (carboplatin and paclitaxel). Patients will receive carboplatin and paclitaxel.
~Drug: Anti-emetic treatment (palonosetron; plus dexamethasone). Palonosetron (0.25 mg IV) on the day of chemotherapy plus dexamethasone (16 mg IV on the day of chemotherapy and 8 or 4 mg (depending on the experimental arm) oral on days 2 and 3 post-chemotherapy)."
16082469|NCT02290470|Drug|Palonosetron, Dexamethasone, Carboplatin, Paclitaxel, Olanzapine|all patients enrolled in the study will receive Palonosetron, Dexamethasone, Carboplatin, Paclitaxel and olanzapine On day 1
16082470|NCT02290457|Behavioral|core strength training|"Both training programs will last 6 weeks and comprise 2 training sessions per week with a total of 12 training sessions for each intervention group. Each training session will last 30 min, starting with a brief warm-up program mainly consisting of core strength exercises at moderate intensities and ending with a cool-down program (i.e., dynamic stretching). During the main part of training, both groups mainly conduct the big 3 exercises as described by McGill. These will include the curl-up, side bridge, and quadruped position. In other words, every single training session will consist of frontal, dorsal, and lateral core exercises. The only difference between the 2 intervention groups is that the CSTU protocol comprise core exercises that will be conducted on unstable elements (e.g., TOGU© DYNAIR PRO, THERA-BAND© STABILITY TRAINER), whereas the CSTS program will contain the same exercises on stable surface only."
16082471|NCT02290444|Drug|Adrenocorticotropic Hormone|Acthar Gel will be administered in accordance with the recommendations set forth in the package insert. The dosage may be individualized according to the medical condition of each patient. Frequency and dose of the drug may be determined by considering the severity of the disease and the initial response of the patient.
16082472|NCT02290431|Drug|LBH589 (panobinostat)|Panobinostat (PAN) capsules were supplied at dose strengths of 10 mg and 15 mg. and dosed at 20mg during treatment phase 1 (21 days) and treatment phase 2 (42 days)
16082473|NCT02290431|Drug|bortezomib|Bortezomib (BTZ) s.c: 1.3 mg/m2 was administered during both treatment phase 1 (21 days) & treatment phase 2 (42 days).
16082474|NCT02290431|Drug|dexamethasone|Dexamethasone (Dex): 20mg tablets taken during both treatment phase 1 (21 days & treatment phase 2 (42 days)
16082475|NCT02290418|Procedure|Roux-en-Y Gastric Bypass|Laparoscopic Gastric Bypass performed with two anastomoses (gastro-enteral and entero- enteral), two limbs (Alimentary limb of length 150cm and Biliary limb of length 75-100cm) and sewing of mesenteric defect.
16082476|NCT02290418|Procedure|Omega-Loop Gastric Bypass|Laparoscopic Gastric Bypass performed with single anastomosis (gastro-enteral) connecting a long gastric pouch to small bowel with Afferent limb of length 200cm.
16082477|NCT02290405|Behavioral|Multiple Sleep Latency Test (MSLT)|The daytime protocol will include a 4-trial Multiple Sleep Latency Test (MSLT) along with 4-trials of a computer -administered battery of reaction time tasks. The assessment protocol will start two to three hours after participants' respective morning rising times and will begin with a battery of the neuro-cognitive testing followed by an MSLT nap. Per standard MSLT procedures, the daytime testing will be scheduled so the four performance testing and sleepiness assessment trials occur two hours apart. All daytime testing will be conducted under the supervision of trained laboratory technologists.
16082478|NCT02290379|Drug|TNX-201 35 mg|Drug: TNX-201 35 mg
16082479|NCT02290379|Drug|TNX-201 70 mg|Drug: TNX-201 70 mg
16082480|NCT02290379|Drug|TNX-201 140 mg|Drug: TNX-201 140 mg
16082481|NCT02290379|Drug|Racemic isometheptene 70 mg|Active Comparator: Racemic isometheptene 70 mg
16082482|NCT02290379|Drug|Placebo|Drug: Placebo
16082483|NCT02290366|Radiation|Focal prostate brachytherapy with Cesium-131|
16082484|NCT02290353|Device|FEATHERS|"FEATHERS Device includes a camera (PS3 Eye), 2 modified PS3 Move controllers, and a computer [2]. A software is designed to search through the camera feed to find the glowing balls attached to PS3 Move controllers, and changes the position of the computer's mouse cursor based on the balls' position. The participants play simple Facebook games that involve point-and-click by using the Move controllers and moving their arms in space to control the cursor and play games.
~During the 8 weeks of intervention, we ask the participants to use the FEATHERS device to play online games (and thus do exercise) on the FEATHERS Facebook app at least 5 days/week, and at least 30 minutes/day. We are interested in seeing how this type of exercise changes the functional clinical scores of the participants."
16082485|NCT02290340|Drug|Placebo|Participants will receive placebo intramuscularly.
16085315|NCT02269670|Drug|tamoxifen citrate|Given PO
16082487|NCT02290340|Drug|MEDI8897 25 mg|Participants will receive a single dose of MEDI8897 25 mg intramuscularly.
16082488|NCT02290340|Drug|MEDI8897 50 mg|Participants will receive a single dose of MEDI8897 50 mg intramuscularly.
16082489|NCT02290327|Drug|Pantoprazole|Proton pump inhibitor
16082490|NCT02290327|Drug|Placebo|50 ml of 0.9% normal saline
16082491|NCT02290314|Procedure|minimally invasive MID-line Lumbar Fusion (MIDLF)|
16082492|NCT02290314|Procedure|Posterior lumbar interbody fusion (PLIF)|
16082493|NCT02290301|Drug|gemigliptin|
16082494|NCT02290288|Procedure|vaginal surgery|
16082495|NCT02290288|Procedure|laparoscopic surgery|
16082496|NCT02290275|Dietary Supplement|Creatine|Subjects will supplement their regular diet with 20 grams of creatine for 1 week and then 5 grams of creatine for the following 11 weeks.
16082497|NCT02290275|Other|Walking Exercise|Subjects will walk on a specialized treadmill that lowers the impact of walking by taking up to 80% of their body weight away. The subjects will exercise by walking on this treadmill at 3.1 mph, 3 days per week for 30 minutes per day for 12 weeks.
16082498|NCT02290275|Dietary Supplement|placebo (maltodextrin)|Subjects will supplement their regular diet with 20 grams of maltodextrin for 1 week and then 5 grams of maltodextrin for the following 11 weeks.
16082499|NCT02290262|Other|Comprehensive phase one rehabilitation|"Patients allocated to the experimental group receive a rehabilitation programme consisting of physical exercise and psycho-education.
~The physical exercises consist of; breathing exercises with and without using incentive spirometry with expiratory positive pressure airway, walking and cycling exercises and neck/shoulder exercises during hospitalisation and an exercise programme running from discharge until 4 weeks following surgery. The psycho-educative rehabilitation programme consists of four psycho-educative consultations with a specially trained nurse."
16082500|NCT02290249|Device|Glidescope|Manikin was intubated by different novice personal with glidescope videolaryngoscope
16082501|NCT02290249|Device|Airtraq|Pediatric manikin was intubated by novice personal with airtraq
16082502|NCT02290236|Device|Pulseoximetry|Peripheral saturation will be recorded continuously
16082503|NCT02290223|Behavioral|Behavioral Based Treatment Model|Behavioral based treatment consists of four 90 minute group sessions, one meeting per week. The sessions addressed: empowering patients to take an active role in pain management and overall health; pain management lifestyle practices; use of health information technology resources for active self-care; education on neurobiology of pain and opioids; and improving communication with providers.
16082504|NCT02290210|Drug|URC102 0.25mg|
16082505|NCT02290210|Drug|URC102 0.5mg|
16082506|NCT02290210|Drug|URC102 1.0mg|
16082507|NCT02290210|Drug|URC102 2.0mg|
16082508|NCT02290210|Drug|placebo|
16082509|NCT02290197|Procedure|Surgery|Surgical reconstruction of all injured ligaments.
16082510|NCT02290197|Device|Hinged External Fixator|Hinged external fixator is used postoperatively for 6 weeks. Early joint mobility in the sagittal plane is encouraged.
16082511|NCT02290197|Device|Cast Immobilization|Cast is used postoperatively for 3 weeks. After this period we use a removable bracing and initiate rehabilitation with physical therapy.
16082512|NCT02290184|Behavioral|PilAm Go4Health Weight-loss Program|This is a 3-month lifestyle intervention program promoting weight loss through physical activity and health diet using a mobile health application (app), pedometer to track daily step-counts, and social networking (in-person and virtual social networking through Facebook) to reduce risks for metabolic syndrome in Filipino Americans with type 2 diabetes on metformin. Subjects will be asked: 1) to use a mobile app diary every day to input their weight, and calories (food and drink intake) and 2) wear a pedometer everyday to monitor their physical activity (step-counts).
16082513|NCT02290184|Behavioral|Active Control|This is a 3-month active control using a pedometer only without any education related to wt loss, physical activity, health eating, or tracking healthy behaviors
16082514|NCT02290171|Behavioral|Activity groups|Children attend to activity groups weekly during the intervention periode.
16082515|NCT02290171|Behavioral|Group based dietary counselling|Parents attend to four sessions of group based dietary counselling
16082516|NCT02290171|Behavioral|Individual counselling|Parents attend to individual counselling focusing on parental skills and family structure
16082517|NCT02290158|Other|Finishing Protocol|Students education, cast models and Panoramic X-ray assessment, brackets reposition and frequent clinical evaluation.
16082518|NCT02290145|Drug|TPF group|"The patients in the experimental group received the TPF induction chemotherapy for 2 cycles followed by radical surgery and post-operative radiotherapy.
~docetaxel:75mg/m2 cisplatin：75 mg/m2 5-Fu：750 mg/m2/day"
16082519|NCT02290145|Procedure|surgery group|The patients in the control group received the radical surgery and post-operative radiotherapy.
16082520|NCT02290145|Radiation|Post-operative radiotherapy|Radiotherapy was arranged 4 to 6 weeks after surgery. Routine external beam radiotherapy, such as conformal or intensity modulated radiotherapy was performed, and the dose was 1.8-2 Gy/day, 5 days/week for 6 weeks, and totally 54-60 Gy.
16082521|NCT02290132|Drug|Rabbit Anti-human Thymocyte Globulin (ATG)|The conditioning regimen in this study consisted of Rabbit antithymocyte globulin (ATG 2.5 mg/kg×4 days) , total-body irradiation (10 Gy in five fractions), cyclophosphamide (60 mg/kg×2 days) and etoposide or teniposide (30-40mg/kg) .
16082522|NCT02290119|Device|Sensor-assisted TKR (Verasense)|Verasense is a single use, disposable device embedded with microelectronics into a standard tibial trial to provide dynamic, intraoperative feedback regarding limb alignment, tibiofermoral position and quantitative pressure at peak contact points in the medial and lateral compartments during total knee replacement surgery. Utilizing sensor-derived data, the surgeon can now evaluate intercompartmental loading throughout the range of motion, and correct for soft-tissue abnormalities while receiving real-time feedback regarding joint balance.
16082523|NCT02290119|Procedure|Control - Without the use of Verasense|Patients in this cohort will undergo manual total knee replacement without the use of Verasense
16082524|NCT02290106|Drug|pitavastatin|
16082525|NCT02290106|Other|PLACEBO|
16082526|NCT02290093|Drug|Standard full-volume PEG|Subjects will be asked to take 4L of PEG-3350 solution the day prior to procedure.
16082527|NCT02290093|Drug|Split-dose full-volume PEG|Subjects will be asked to take 2L of PEG-3350 solution the day prior to procedure, followed by another 2L of PEG-3350 solution on the day of the procedure.
16082528|NCT02290093|Drug|Split-dose low-volume PEG|Subjects will be asked to take 1L of PEG-3350 containing ascorbic acid solution the day prior to procedure, followed by another 1L of PEG-3350 containing ascorbic acid solution on the day of the procedure.
16082529|NCT02290080|Drug|Oxygen|see arm description
16082530|NCT02290067|Device|Blood glucose monitoring system (Omnitest 3)|
16082531|NCT02290067|Device|Blood glucose monitoring system (Omnitest 5)|
16082532|NCT02290067|Device|Blood glucose monitoring system (Omnitest 5D)|
16082533|NCT02290054|Procedure|Control|Implementation of adhesive pads on the ears is performed while the patient is sleeping but before thoracic incision.
16082534|NCT02290054|Procedure|Treated|Auriculotherapy uses semi-permanent needles and implementation of adhesive pads to mask the needles.
16082535|NCT02290054|Procedure|Intra-venous anesthesia|
16082536|NCT02290041|Drug|Infusion of MSC|Intravenous infusion of 4 doses of adipose tissue derived allogeneic adult mesenchymal stem cells (1 million MSCs/Kg, weeks 0-4-8-20).
16082537|NCT02290041|Drug|Infusion of placebo|Infusion of placebo (weeks 0-4-8-20)
16082538|NCT02290028|Device|Sentus QP left ventricular lead|Implantation of quadripolar left ventricular lead in patients with CRT-D indication
16082539|NCT02290015|Other|Acupuncture|All treatments were performed by the same acupuncturist, who is a medical doctor with more than eight years of clinical and research experience in ACP for tinnitus. Acupoints described as being effective for tinnitus were selected according to TCM theory. Basic points that are manipulated in ACP include GV 20 (Baihui), TE 17 (Yifeng), GB 8 (Shuaigu), SI 19 (Tinggong), GB 2 (Tinghui), TE 21 (Ermen), VC 23 (Lianquan), GB 20 (Fengchi), TE 2 (Yemen), TE 5 (Waiguan), SI 2 (Qiangu), GB 43 (Xiaxi) and GB 41 (Zulinqi). However, several secondary (accessory) acupoints were also added according to TCM and the etiological diagnosis of tinnitus: GV 4 (Mingmen), KI 3 (Taixi), BL 23 (Shenshu), BL 19 (Danshu), BL 18 (Ganshu) and CV 4 (Guanyuan).
16082540|NCT02290002|Drug|Calcium Dobesilate|1 cap / 8 hs Calcium Dobesilate ( 500mg) will be given at day of HCG injection and for 21 days
16082541|NCT02290002|Other|coasting|In group B, coasting (withholding gonadotrophins while maintaining pituitary suppression) for 3 days then either giving triggering or cycle cancellation is done
16082542|NCT02289989|Drug|Oregano extract cream|An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment
16082543|NCT02289989|Drug|Hydrocortisone|An experimental cream will be applied to one of the arms of the patient which will be an oregano extract and will be compared to the standard treatment which will be hydrocortisone 1% ointment
16082544|NCT02289976|Procedure|core decompression|Drilling of the avascular necrosis of the talus by 10mm drill under x-ray control
16082545|NCT02289963|Drug|Placebo (for Alirocumab)|Solution for injection, one subcutaneous injection in the abdomen with a disposable auto-injector.
16082546|NCT02289963|Drug|Alirocumab|Solution for injection, one subcutaneous injection in the abdomen with a disposable auto-injector.
16082547|NCT02289963|Drug|Lipid-Modifying Therapy (LMT)|Statins (Rosuvastatin, Simvastatin or Atorvastatin) at stable dose with or without other LMT as clinically indicated.
16082548|NCT02289950|Drug|Farletuzumab|Farletuzumab will be administered intravenously (IV) weekly
16082549|NCT02289950|Drug|Placebo|Placebo will be administered intravenously (IV) weekly
16082550|NCT02289937|Drug|Ropivacaine|
16082551|NCT02289937|Drug|Placebo|
16082552|NCT02289937|Device|An ultrasound-guided Nervus cutaneous femoral lateralis blockade will be given postoperatively|
16082553|NCT02289924|Drug|Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)|Administration by intravitreal injection
16082554|NCT02289911|Other|Didactic training in the FAST|Participants in the classroom group (class) listened to traditional lectures, while the web group (web) watched narrated lectures online. All participants completed a pre- and post-test, and a second post-test eight weeks later. Both groups underwent hands-on training after the first post-test.
16082555|NCT02289898|Drug|Demcizumab|administered intravenously
16082556|NCT02289898|Drug|Abraxane®|administered intravenously
16082557|NCT02289898|Drug|gemcitabine|administered intravenously
16082558|NCT02289898|Drug|Placebo|
16082559|NCT02289885|Device|SonoScape|Ultrasonography device
16082560|NCT02289872|Device|Macintosh Laryngoscope|Direct-Laryngoscopy
16082561|NCT02289872|Device|TruView PCD Video laryngoscope|Video-Laryngoscopy
16082562|NCT02289859|Procedure|Wound Closure with Undermining|The side assigned to undermining will have undermining performed prior to wound closure in the subcutaneous plane. The amount of undermining will range from 1 cm for wounds with low tension to 2 cm for those with moderate tension. Since wound diameter will be 3 cm or less and exclude the scalp, high tension wounds are not anticipated.
16082563|NCT02289859|Procedure|Wound Closure without Undermining|One side of the wound will remain un-undermined.
16082564|NCT02289846|Drug|IW-9179|
16082565|NCT02289846|Drug|Matching Placebo|
16082566|NCT02289833|Drug|Trastuzumab Emtansine|Trastuzumab emtansine will be administered intravenously (IV) at a dose of 3.6 mg/kg on Day 1 of every 21-day cycle until disease progression (as assessed by the investigator), unmanageable toxicity, or study termination by the sponsor, whichever occurs first.
16082567|NCT02289820|Biological|MEDI7510|RSV sF antigen plus adjuvant
16082568|NCT02289820|Biological|IIV|Marketed Inactivated Influenza Vaccine
16082569|NCT02289807|Drug|Cisplatin|concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles during IMRT
16082570|NCT02289807|Radiation|IMRT|Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.30 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor
16082571|NCT02289794|Biological|E.coli bioconjugate vaccine|Single dose, intramuscular injection (0.5 mL)
16082572|NCT02289794|Biological|Placebo|Single dose, intramuscular injection (0.5 mL)
16082573|NCT02289781|Device|posterior crowns|teeth will be prepared to receive posterior crown made of either zirconia or metal-ceramic material
16082574|NCT02289768|Drug|5-fluorouracil/salicylic acid|
16082575|NCT02289768|Drug|Vehicle|
16082667|NCT02289183|Procedure|Totally laparoscopic distal gastrectomy|Totally laparoscopic distal gastrectomy with modified delta-shaped gastroduodenostomy
16085316|NCT02269670|Drug|fulvestrant|Given IM or PO
16082576|NCT02289755|Drug|ALLN-177|ALLN-177 is orally administered oxalate decarboxylase (OxDc). The goal of oral therapy with ALLN-177 is to enzymatically degrade both dietary oxalate and endogenously produced oxalate secreted in the gastrointestinal tract resulting in decreased absorption and reduced urinary oxalate excretion.
16082577|NCT02289742|Device|Nelfilcon A multifocal contact lenses|
16082578|NCT02289742|Device|Nelfilcon A toric contact lenses|
16082579|NCT02289742|Device|Nelfilcon A sphere contact lenses|
16082580|NCT02289716|Drug|Placebo|Placebo will be administered once every 4 weeks for 16 weeks by subcutaneous (SC) injection (injection under the skin) into the thigh or abdomen.
16082581|NCT02289716|Drug|Fulranumab 1 mg|Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen.
16082582|NCT02289716|Drug|Fulranumab 3 mg|Fulranumab will be administered once every 4 weeks for up to 16 weeks by SC injection into the thigh or abdomen.
16082583|NCT02289703|Drug|Rivaroxaban 15 mg|Single oral dose of rivaroxaban 15-mg tablet on Day 1 of each of the treatment periods.
16082584|NCT02289690|Drug|Veliparib|Capsules administered orally twice a day according to the dosing schedule.
16082585|NCT02289690|Drug|Carboplatin|Administered by intravenous infusion on Day 1 of each 21-day cycle over approximately 30 minutes at a target area under the curve (AUC) 5 mg/mL*minute.
16082586|NCT02289690|Drug|Etoposide|Administered by intravenous infusion on Days 1 to 3 of every 21-day cycle over approximately 60 minutes at 100 mg/m².
16082587|NCT02289690|Drug|Placebo|Placebo to veliparib administered orally twice a day according to the dosing schedule.
16082588|NCT02289677|Device|ATMOS Scope|Video-laryngoscopy 1
16082589|NCT02289677|Device|COOPDECH|Video-laryngoscopy-1
16082590|NCT02289677|Device|AirTraq|Optical-laryngoscopy
16082591|NCT02289664|Device|MAC|Direct-Laryngoscopy
16082592|NCT02289664|Device|Coopdech|Video-Laryngoscopy -1
16082593|NCT02289664|Device|CoPilot|Video-Laryngoscopy -2
16082594|NCT02289664|Device|Intubrite|Video-Laryngoscopy -3
16082595|NCT02289651|Device|Venner|Video-laryngoscopy
16082596|NCT02289651|Device|Miller|Direct-Laryngoscopy
16082597|NCT02289638|Device|Intubrite|Video-Laryngoscopy
16082598|NCT02289638|Device|MIL|Direct-Laryngoscopy
16082599|NCT02289625|Other|Exercise Training|six month of Exercise training will be conducted in individuals with moderate to severe sleep apnea. The training include aerobic exercise, resistance exercise, flexibility.
16082600|NCT02289612|Other|Yellow Mustard Gum Fibre|
16082601|NCT02289612|Other|Soluble Flaxseed Gum Fibre|
16082602|NCT02289612|Other|Fenugreek Gum Fibre|
16082603|NCT02289599|Drug|E2307|
16082604|NCT02289599|Drug|E2307 Matching Placebo|
16082605|NCT02289586|Procedure|invasive ventilation|
16082606|NCT02289586|Procedure|interventional bronchoscopy|
16082607|NCT02289586|Device|noninvasive ventilation|
16082608|NCT02289586|Drug|sedation(dezocine and midazolam)|
16082609|NCT02289586|Drug|general anesthesia(midazolam, fentanyl，rocuronium，propofol and Remifentanil）|
16082610|NCT02289573|Device|NAVA and PSV|change ventilation modes(NAVA and PSV) with different support levels
16082611|NCT02289560|Device|Transcranial ExAblate|Transcranial ExAblate
16082612|NCT02289547|Drug|Capecitabine|maintenance capecitabine therapy after six cycles of XELOX
16082613|NCT02289521|Device|Transcranial Direct Current Stimulation|"We will use a non-invasive, reversible transcranial direct current stimulation (tDCS) using a low-intensity electrical current. We will use Anodal and Sham tDCS.
~Anodal: Active anodal electrode over F3 (EEG system) and return electrode over right supraorbital area. A 1.5mA current will flow between the electrodes for 20min. To decrease current-induced injuries, at the beginning, the current reaches from 0 to 1.5mA during 30 seconds (fade-in), and decreases from 1.5mA to 0 in 15 seconds at the end (fade-out).
~Sham: The parameters mimics the A-tDCS (i.e. electrode placement, fade-in and current intensity), except the duration of stimulation: the current will reach to 1.5mA in 30 seconds (fade-in) and lasts only for 30 seconds (to give the initial sensation of stimulation)."
16082614|NCT02289508|Device|Ultrasonic cardiac output monitor|An Ultrasonic Cardiac Output Monitor, a non-invasive Doppler ultrasonography, is capable of measuring haemodynamic parameters non-invasively and appears to be simple and rapid to use, portable, relatively inexpensive and has less potential complications compared with the standard technique, pulmonary artery thermodilution (PATD). It has been compared favorably with a wide range of standard techniques, including PATD, with good interobserver reliability. USCOM may help on monitoring HF and suggesting proper treatment in order to reduce the mortality of adHF.
16082615|NCT02289508|Device|Echocardiography|2D-echo is a conventional standard-of-care tool for non-invasive hemodynamic assessments in adults. The use of 2D-echo requires highly trained personnel, and assessments may take anywhere between 30-45 minutes. It is used to find out the ejection fraction and to compare the haemodynamic parameters with USCOM in this study.
16082616|NCT02289495|Drug|GSK2838232|GSK2838232 will be available as oral suspension dispersion in hydromellulose acetate succinate bulk powder/10, 20 and 50 mg which is to be administered orally QD for 8 days (Part A) or 11 days (Part B), morning dose, following an overnight fast of at least 10 hours
16082617|NCT02289495|Drug|Placebo|Matching placebo of Suspension to active dose, administered orally QD for 8 days (Part A) or 11 days (Part B), morning dose, following an overnight fast of at least 10 hours
16082618|NCT02289495|Drug|Ritonavir|Ritonavir will be available as white film-coated ovaloid tablets of 100 mg tablet/100mg to be administer orally, QD
16082619|NCT02289482|Drug|GSK2838232 PIB (SDD)|GSK2838232 will be available as oral suspension dispersion in hydromellulose acetate succinate bulk powder/10, 20, 50, 200 and 500 mg in part A, while 100 mg in Part B. GSK2838232 will be administered orally once daily (QD) as single doses in the morning following an overnight fast of at least 10 hours.
16082620|NCT02289482|Drug|GSK2838232 PIB (API)|GSK2838232 will be available as oral suspension bulk powder/100 mg in Part B. GSK2838232 will be administered orally QD as single doses in the Morning following an overnight fast of at least 10 hours.
16082621|NCT02289482|Drug|Placebo|Matching placebo of Suspension to active dose, administered orally QD as single doses in the morning following an overnight fast of at least 10 hours.
16082668|NCT02289183|Procedure|Laparoscopy-assisted distal gastrectomy|Laparoscopy-assisted distal gastrectomy with Billroth-I anastomosis
16082622|NCT02289482|Drug|Ritonavir|Ritonavir will be available as white film-coated ovaloid tablets of 100 mg tablet/100mg. Ritonavir will be administered orally, once daily in Part A, Period 3 Days 1-14 and Period 4 from Days 1-12 and will be administer orally once daily in Part B for 9 days prior to dosing in Period 3 and on Days 10-14 of Period 3.
16082623|NCT02289469|Other|PictureRx medication history platform|Tablet PC-based tool to take more complete and accurate medication history
16082624|NCT02289456|Drug|nab-Paclitaxel|
16082625|NCT02289456|Drug|Carboplatin|
16082626|NCT02289443|Other|complete denture|Comparison of different procedures
16082627|NCT02289430|Drug|Crestor+Ezetrol|rosuvastatin+ezetimibe
16082628|NCT02289430|Drug|Ezetrol|ezetimibe
16082629|NCT02289430|Drug|Crestor|rosuvastatin
16082630|NCT02289417|Drug|Apremilast|
16082631|NCT02289417|Drug|Placebo|
16082632|NCT02289404|Drug|NVP-1203|Oral
16082633|NCT02289404|Drug|NVP-1203|Oral
16082634|NCT02289391|Drug|Anesthesia induction|-Intravenous injection midazolam 0.05 mg/Kg,fentanyl 4μg/Kg,etomidate 0.2 mg/Kg,cisatracurium 0.15 mg/Kg in proper order.
16082635|NCT02289391|Drug|Anesthesia maintenance|"Continuous intravenous remifentanil O.2μg/(kg•h) and propofol 3~8mg/(kg•h).
~Intermittent intravenous atracurium 0.05mg/kg. Maintain partial pressure of carbon dioxide(PETCO2) to 30~40 mmHg and bispectral index (BIS) to 45~60."
16082636|NCT02289391|Drug|Assisted anesthesia|Intervention 'Assisted anesthesia' has been included in Arm Descriptions.
16082637|NCT02289378|Drug|Docetaxel, Oxaliplatin and 5-Fu|To investigate the triplet regimen in the first-line therapy of advanced chemotherapy
16082638|NCT02289365|Drug|2000 mg of JBM-TC4 per day|2 capsules of 500 mg JBM-TC4 plus 1 capsule of 500 mg PEG-400, oral route per time twice a day in Day (-7) prior to radiotherapy and continue through the radiotherapy period for additional 11 weeks.
16082639|NCT02289365|Drug|3000 mg of JBM-TC4 per day|3 capsules of 500 mg JBM-TC4, oral route per time twice a day in Day (-7) prior to radiotherapy and continue through the radiotherapy period for additional 11 weeks.
16082640|NCT02289365|Drug|3000 mg of PEG-400 per day|3 capsules of 500 mg polyethylene glycol 400 (PEG-400), oral route per time twice a day in Day (-7) prior to radiotherapy and continue through the radiotherapy period for additional 11 weeks.
16082641|NCT02289352|Drug|Brimonidine|
16082642|NCT02289352|Drug|placebo|
16082643|NCT02289339|Device|aortic valve prostheses|balloon-expandable and self-expandable aortic valve prostheses
16082644|NCT02289313|Behavioral|Healthy Youth Living Program|Physical activity and healthy eating program at the Alternative Learning Center co-developed by students, school staff and academic partners.
16082645|NCT02289300|Drug|DCB-BO1202|"The assignment will be as follows:
~(Each DCB-BO1202 300mg capsule contains 150mg active ingredient)
~DCB-BO1202: 4 DCB-BO1202 300mg capsules, t.i.d., orally.
~Duration of Administration: 96 weeks ((11 treatment weeks + 1 observation week) * 8 cycles)"
16082646|NCT02289300|Drug|Placebo|"The assignment will be as follows:
~Placebo: 4 matched placebo, t.i.d., orally.
~Duration of Administration: 96 weeks ((11 treatment weeks + 1 observation week) * 8 cycles)"
16082647|NCT02289300|Drug|DCB-BO1202+Placebo|"The assignment will be as follows:
~(Each DCB-BO1202 300mg capsule contains 150mg active ingredient)
~DCB-BO1202+Placebo: 2 DCB-BO1202 300mg capsules plus 2 matched placebo, t.i.d., orally.
~Duration of Administration: 96 weeks ((11 treatment weeks + 1 observation week) * 8 cycles)"
16082648|NCT02289287|Behavioral|Self-Management group-intervention|At enrollment eligible patients will be randomized to Intervention + Standard Care or Standard Care group. Within 3 weeks after enrollment all participants will undergo baseline assessment using a predefined set of scales and questionnaires (intervention group will additionally undergo a semi-structured interview). The group-intervention (SM program) will begin after enrollment of at least 4 participants to the intervention group, and within no longer than 5 weeks since enrollment. The intervention will include 12 weekly sessions, each session 2.5 hour long, and will be based on well-known SM interventions that were found effective for stroke patients in the U.S. Follow-up assessments will be done at 12 and 36 week to examine long term effectiveness.
16082649|NCT02289287|Behavioral|Standard Care|At enrollment eligible patients will be randomized to Intervention + Standard Care or Standard Care group. Within 3 weeks after enrollment all participants will undergo baseline assessment using a predefined set of scales and questionnaires (intervention group will additionally undergo a semi-structured interview). Standard care will include 'one-on-one' sessions in each paramedical discipline as given regularly in this setting (average of 15-20 sessions per patient). Follow-up assessments will be done at 12 and 36 week to examine long term effectiveness.
16082650|NCT02289274|Drug|NVP-1203|NVP-1203(eperisone SR + aceclofenac)
16082651|NCT02289274|Drug|Eperisone SR tab. + and Airtal tab.|Eperisone SR and aceclofenac
16082652|NCT02289261|Drug|Morphine|Morphine, 0.02 mg/kg PCA bolus dose with 10 minutes lock-out interval
16082653|NCT02289261|Drug|Morphine plus dexmedetomidine|Morphine 0.02 mg/kg plus dexmedetomidine 0.1 microgram/kg PCA bolus dose with 10 minutes lock-out interval
16082654|NCT02289248|Drug|Ketamine|Subjects will undergo a twice weekly two week course of IV infusions of ketamine
16082655|NCT02289248|Behavioral|Cognitive Behavioral Therapy (CBT)|Subjects will undergo twice weekly CBT for a total of 8 weeks
16082656|NCT02289235|Drug|Ginger|Ginger powder capsule 1000 mg twice daily for 3 months
16082657|NCT02289235|Drug|Placebo|Placebo powder 2 capsules twice daily for 3 months
16082658|NCT02289222|Drug|MK-3475|Anti PD-1 (MD 3475) will be given as an intravenous infusion at 200 mg every 2 weeks.
16082659|NCT02289222|Drug|Pomalidomide|Pomalidomide is given at standard dose of 4 mg daily orally for 21 days
16082660|NCT02289222|Drug|Dexamethasone|Dexamethasone is given at 40 mg orally weekly
16082661|NCT02289209|Radiation|Reirradiation|Reirradiation 1.2 GY BID 5 days a week for 5 weeks.
16082662|NCT02289209|Drug|MK-3475|MK-3475 will be given at 200mg intravenous every 3 weeks starting day one of reirradiation and will be continued once every 3 weeks until 3 months post completion of reirradiation. Further continuation of MK-3475 will be determined by response evaluation at 3 months post completion of reirradiation
16082663|NCT02289196|Drug|Vx-006: 0,5mg|
16082664|NCT02289196|Drug|Vx-006: 1mg|
16082665|NCT02289196|Drug|Vx-006: 5mg|
16082666|NCT02289196|Drug|Vx-006: 10mg|
16085317|NCT02269670|Drug|megestrol acetate|Given PO
16082669|NCT02289170|Device|Heating and cooling combination therapy|The treatment was applied 10 times for 4 weeks. Most painful 2 points in 8 acupuncture points(both side of Bladder meridian23 (BL23), BL24, BL25, BL26) were used for all the patients assigned to this group.
16082670|NCT02289170|Device|Sham heating and cooling therapy|The treatment was applied 10 times for 4 weeks. The sham heating and cooling combination therapy was applied on the 2 of 8 same acupuncture points as in the treatment group.
16082671|NCT02289157|Device|Negative pressure wound therapy|Single use negative pressure wound therapy systems are composed of a pressure pump and dressing kit. The pump creates a negative pressure of 125 mmHg (+/- 20 mgHg) and the dressing directly covers surgical incision. The system is battery-powered and designed to be used for a minimum of two days and a maximum of seven days of continuous use. The investigators hypothesize that negative pressure wound therapy will decrease the wound complications in these patients. The investigators will be using Prevena Incision Management System as the negative pressure device in our study.
16082672|NCT02289144|Drug|Ceritinib|750 mg orally daily on day 1. Continue every 4 weeks and every 2 cycles (1 Cycle is 28 days long) : until progression, new recurrence or distant metastasis, as well as enlargment of an existing metastasis on radiological Imaging.
16082673|NCT02289131|Procedure|Tooth Brushing Protocol|A 2-minute tooth brushing protocol, followed by a mouthwash rinse and application of moisturizer for a total of approximately 15 minutes.
16082674|NCT02289118|Drug|[18F]-T807 imaging tracer|Tau Imaging tracer
16082675|NCT02289105|Behavioral|Mandatory active choice|the mandatory active choice group, will be presented two forms at the same time. The first form will be a legally valid AD. The second form will be a declination form. Participants in the intervention arm will be required to complete, and submit either of the two forms the task.
16082676|NCT02289092|Behavioral|Family Check-Up|Parents fill out questionnaires about their child and families and then participate in a videotaped interaction with their child. Clinicians then observe the video and analyze the questionnaires to establish family needs based on supports, stress, parenting, values, and strengths. Therapists then use this information to inform the intervention process and provide feedback to families with the use of motivational interviewing. parents identify goals for parenting and/or child behavior and to connect them with resources when needed. Feedback includes a discussion of goal attainment and plans to achieve goals. Goal achievement includes options such as (a) periodic follow-up and support, (b) brief support for change on a specific topic, and (c) community referral (e.g., substance abuse referral; domestic violence referral; referral for individual therapy for depression; referral for family therapy and support for families in conflict).
16082677|NCT02289079|Drug|Bupivacaine|
16082678|NCT02289079|Drug|liposomal bupivacaine|
16082679|NCT02289040|Procedure|cardiac surgery|cardiac surgery with extracorporeal circulation for congenital heart disease
16082680|NCT02289027|Biological|cAd3-EBOZ vaccine|
16082681|NCT02289027|Biological|Placebo (for cAd3-EBOZ vaccine)|Diluent
16082682|NCT02289014|Other|online stress Management program|Active treatment group
16082683|NCT02289001|Behavioral|Education on SBAR worksheet|The intervention group will receive one hour of training in teamwork skills, distribution of roles and use of the SBAR worksheet before participating in the simulated scenario using a human patient simulator (HPS).
16082684|NCT02288988|Procedure|Antireflux Surgery|Collis gasytroplasty Nissen antireflux fundoplication
16082685|NCT02288975|Device|CytoSorb 300ml device (3804606CE01)|
16082686|NCT02288962|Drug|cabergoline|
16082687|NCT02288949|Other|stratification|Patients will be stratified based on the values of relevant demographics, pulmonary and systemic variables in relation to mortality in the intensive care unit.
16082688|NCT02288936|Drug|Enzalutamide|Enzalutamide 160 mg/day
16082689|NCT02288923|Procedure|Femoral nerve block|"Supine position
~If using peripheral nerve stimulator for localisation of the femoral nerve:
~50 mm insulated needle Peripheral nerve stimulator set at 2 Hz with pulse width 100μs When quadriceps muscle twitch is present with a stimulated current between 0.2 and 0.5mA, inject 20ml 0.375% (3.75mg/ml) Levo- bupivacaine
~If using ultrasound for localisation of the femoral nerve:
~High frequency linear array probe Short bevelled nerve-block needle, using in or out of plane technique Inject 20ml 0.375% (3.75mg/ml) Levo-bupivacaine underneath fascia iliaca ensuring adequate spread of local anaesthetic"
16082690|NCT02288923|Procedure|Local Infiltration Analgesia|"Local infiltration analgesia to be administered by surgeon towards the end of operation:
~40ml of bupivacaine 0.25% with adrenaline 1:200 000, diluted to 150ml with saline 0.9%. This is then divided into thirds; 50ml into the posterior capsule before cementing, 50ml into the medial and lateral capsules and 50ml into subcutaneous tissues and in and around the vastus medialis and sartorius muscles (where it may block the saphenous nerve)."
16082691|NCT02288923|Procedure|Sub arachnoid analgesia|Patients in both arms of the trial will be given sub arachnoid anasthesia of 2.5-3.0ml of plain bupivacaine 0.5% using a 25G Whitacre needle. Patients may have 0-4mg midazolam and/or 0-1mcg/kg fentanyl and/or 0-4mcg/ml propofol sedation using the Marsh protocol if required for this procedure as deemed appropriate by the anaesthetist.
16082692|NCT02288923|Procedure|Sedation or general anaesthesia|After insertion of the sub arachnoid anaesthesia the patient may choose to be fully asleep or sedated. If they choose to be fully asleep, they may have up to 2mcg/kg fentanyl in total (including any given at time of subarachnoid injection), muscle relaxation as indicated for facilitation of intubation where needed, airway control using LMA or tracheal tube where needed, and general anaesthesia maintained using inspired oxygen concentration of 0.3-0.7 with propofol up to 5mcg/kg (Marsh protocol) or isoflurane or sevoflurane. If the patient chooses to have sedation they may have additional midazolam up to a total dose of 4mg and/or a propofol infusion (Marsh protocol) of 0-4mcg/ml.
16082693|NCT02288923|Drug|Pre-medication|All patients will receive 1g paracetamol pre-operatively. Those on non steroidal anti inflammatory drugs may continue to take them. Apart from these, no other pain relieving pre-medications are to be used. Patients may be given anxiolysis using temazepam 10-20mg or diazepam 2-5mg by mouth if required. Antacid premedication is permitted using ranitidine, metoclopramide or proton pump inhibitors.
16082728|NCT02288663|Device|Dual X-ray absorptiometry (DXA)|measurement of lean body mass by whole-body DXA
16082729|NCT02288663|Device|Bioelectric Impedance Spectroscopy (BIS)|measurement of lean body mass by BIS
16082730|NCT02288663|Biological|51Cr-EDTA plasma clearance|measurement of 51Cr-EDTA plasma clearance to determine GFR
16082731|NCT02288650|Other|early refeeding|
16082694|NCT02288923|Drug|Intra-operative medication|If paracetamol has not been given pre-operatively, it will be given intraoperatively 1g IV. Where 2 or more of the following risk factors are present; female, non smoker, previous post operative nausea or vomiting, intra operative opiates, the patients will be given 4mg dexamethasone and or 4mg ondansetron IV. Vasopressor drugs may be given at the anaesthetist's discretion to maintain an appropriate blood pressure. Intraoperative fluid infusion is at the discretion of the anaesthetist. Antibiotic prophylaxis is as per the hospital protocol (currently 6mg/kg Teicoplanin IV and 3mg/kg gentamicin pre induction). Tranexamic acid will be given as per unit protocol, (currently 1g pre-operatively IV and 500mg orally at 8 hours post op. unless contraindicated by a high risk of thrombosis.)
16082695|NCT02288923|Drug|Post-operative analgesia - morphine|Patients will all be given a morphine pump which will give 1mg every 5 minutes. This is to be discontinued after 48 hours and changed to oral morphine 10-20mg if weight 50-70kg, 20-30mg if weight >70kg 2 hourly.
16082696|NCT02288923|Drug|Post-operative analgesia - ibuprofen and paracetamol|All patients will be given 1g paracetamol 6 hourly and 400mg ibuprofen 8 hourly unless there are contraindications. If patients are on an alternative non-steroidal anti inflammatory drug then this may be substituted for ibuprofen.
16082697|NCT02288923|Drug|Regular anti emetics|All patients will receive 4mg ondansetron regularly for 2 days. They will be prescribed 50mg cyclizine as an addition to this if needed.
16082698|NCT02288897|Drug|PV-10 (10% rose bengal disodium)|
16082699|NCT02288897|Drug|Dacarbazine, temozolomide or talimogene laherparepvec|
16082700|NCT02288884|Device|Acticoat PostOp|
16082701|NCT02288884|Device|OpSite PostOp|
16082702|NCT02288871|Radiation|Cardiac CT-scan|"ECG gated CT angiography of the heart will be performed on a 128-slice dual-source and two Stellar detectors CT system with retrospective ECG-gating (Siemens/SOMATOM Definition Flash - Siemens, Germany, 100kV, 395.75 mAs).
~In details, multi-phase images will be acquired to reconstruct between 10 and 100% of the cardiac cycle (10% increments) with a slice thickness of 1 mm. Examination will include left ventricular outflow tract, aortic root, coronary sinus, ascending aorta together with the prosthetic valves."
16082703|NCT02288858|Dietary Supplement|Viviscal Oral Supplement Tablets|Tablet (512 mg)
16082704|NCT02288845|Drug|ITI-007|
16082705|NCT02288832|Other|-self-collected vaginal samples|
16082706|NCT02288832|Drug|zithromax|
16082707|NCT02288832|Other|usual practices|
16082708|NCT02288819|Device|Weight monitoring|The body weight of patients is measured each morning in identical conditions on the same balance during 7 days
16082709|NCT02288819|Drug|Loop diuretic downtitration|"The patient's total daily maintenance dose of loop diuretics is downtitrated during 7 consecutive days.
~In case of a total daily maintenance dose ≤40 mg furosemide OR ≤1 mg bumetanide OR ≤20 mg torsemide, the loop diuretic is completely stopped.
~In case of a total daily maintenance dose >40 mg furosemide OR >1 mg bumetanide OR >20 mg torsemide, the loop diuretic dose is halved."
16082710|NCT02288793|Other|Survey|Survey about Knowledge and Attitude About Focused Assessment With Sonography in Trauma
16082711|NCT02288767|Device|Conventional arterial blood pressure monitoring|
16082712|NCT02288767|Device|Stroke volume variation monitoring with arterial blood pressure monitoring|
16082713|NCT02288754|Diagnostic Test|Blood test|No intervention except to collect blood for diagnostic test development
16082714|NCT02288741|Drug|Anthracycline/dexamethasone-based induction chemotherapy|4 cycles of anthracycline/dexamethasone-based chemotherapy
16082715|NCT02288741|Drug|Dexamethasone for control of symptoms|2 x 4 days of dexamethasone (day 1-4 and day 8-11: 40mg)
16082716|NCT02288741|Drug|Tumor-reduction chemotherapy and stem cell mobilization|Ifosfamide (day 1-3: 1.900mg/m² iv), epirubicin (day 1: 75 mg/m² iv), etoposide (day 1-3: 120 mg/m² iv) and G-CSF (day 5 until end of apheresis: 5µg/kg sc)
16082717|NCT02288741|Procedure|Stem cell apheresis|stem cell apheresis in peripheral blood, sought amount of CD34-cells: 6 * 10E6/kg
16082718|NCT02288741|Drug|Tandem high-dose chemotherapy (melphalan)|Two cycles of high-dose melphalan (day -3 and day -2: 70mg/m²)
16082719|NCT02288741|Procedure|Autologous peripheral blood stem cell transplantation|Two infusions of collected stem cells (day 0: 2*10E6 CD34-cell/kg per transplantation)
16082720|NCT02288728|Procedure|Gastric tube anastomosis|"In the gastric tube group, the lesser curvature of the gastric remnant approximately 3 cm proximal to the pylorus was removed first by a linear stapling device. An approximately 5-cm-wide tubular stomach was then constructed with preserved right gastric vessels. The length of the tube was consistent with the greater curvature of the residual stomach. The reconstructed gastric tube was lastly anastomosed with the proximal esophageal end.
~(Reference: Chen XF, Zhang B, Chen ZX, Hu JK, Dai B, Wang F, Yang HX, Chen JP. Gastric tube reconstruction reduces postoperative gastroesophageal reflux in adenocarcinoma of esophagogastric junction. Dig Dis Sci. 2012;57(3):738-745.)"
16082721|NCT02288728|Procedure|Double-track anastomosis|"Double-track anastomosis group: First, cut off the jejunum about 15-20 cm away from the Treitz ligament; Second, Roux-en-Y esophagojejunostomy (E-J stomy, first anastomosis) was perform by 25mm circular stapler device; Third, from 30-40cm to the E-J stomy, perform the side-to-side gastrojejunostomy (G-J stomy, second anastomosis). Forth, from 25-30cm to the G-J stomy, perform the jejunojejunostomy (J-J stomy, third anastomosis).
~(Reference: Ahn SH, Jung do H, Son SY, Lee CM, Park do J, Kim HH. Laparoscopic double-tract proximal gastrectomy for proximal early gastric cancer. Gastric Cancer. 2014;17(3):562-70.)"
16082722|NCT02288715|Other|no interventions|
16082723|NCT02288702|Device|monitoring BIS in both groups|We will be monitoring BIS in both groups. A BIS monitor may be placed prior to induction or immmeditaely afterwards for monitoring BIS. All patients will receive general anesthesia. A standard inhalation induction agent such as sevoflurane and oxygen will be administered via face mask with or without an oral airway. An inhalation agent will be administered for the duration of the procedure. The MAC goal for inhalation agents will be 1. If the patient moves, the MAC goal will be increased to 1.5 and this change will be recorded.
16082724|NCT02288689|Device|Acuuvix SonoAce UGEO|Ultrasonographic vaginal examination
16082725|NCT02288663|Other|measurement of morphological parameters|measurement of morphological parameters : thigh perimeter, leg perimeter, arm perimeter.
16082726|NCT02288663|Biological|a blood sample|One single blood sample to assay SCr (enzymatic), BUN (blood urea nitrogen), cystatin C, CRP, Na, K, Cl, albuminemia.
16082727|NCT02288663|Biological|albumin or blood in urine|dipstick analysis for albumin or blood in urine
16082732|NCT02288650|Other|refeeding only in the recovery room (usual practice).|
16082733|NCT02288637|Other|Olyset Plus LLIN|Olyset Plus is a LLIN containing the pyrethroid permethrin and the synergist piperonyl butoxide PBO as the active ingredients (AI).The LLIN can withstand repeated washing and retains efficacy over years of use
16082734|NCT02288637|Other|Conventional Olyset LLIN|Olyset Plus is a LLIN containing the pyrethroid permethrin. The LLIN can withstand repeated washing and retains efficacy over years of use.
16082735|NCT02288637|Other|IRS|Actellic CS (Syngenta), is a microcapsule formulation of the organophosphate insecticide, pirimiphos-methyl. Microencapsulation greatly extends the compound's residual life when applied to interior walls and ceilings. Evaluation by LSHTM in experimental huts in Tanzania showed residual activity of more than a year. Parallel trials in Benin against pyrethroid-resistant mosquitoes killed more than 80% of An. gambiae for up to 10 months.
16082736|NCT02288624|Dietary Supplement|Processed orange juice|3 different formulation of edible orange drinks
16082737|NCT02288611|Dietary Supplement|Date fruit - Ajwa variety|Twenty-two healthy human individuals were randomly assigned to consume 7 date fruits (approx. 50g). Each arm was 21 days in duration, separated by a 14 days washout period.
16082738|NCT02288611|Dietary Supplement|Maltodextrin/Dextrose|Twenty-two healthy human individuals were randomly assigned to consume Maltodextrin/dextrose , 40.2g. Each arm was 21 days in duration, separated by a 14 days washout period.
16082739|NCT02288598|Device|Anodal TDCS|20 minutes 1mA anodal stimulation to left inferior frontal cortex. Cathode positioned on right supra-orbital ridge.
16082740|NCT02288598|Behavioral|Fluency Training|Speech tasks will be completed using fluency-enhancing techniques: metronome-timed speech and auditory choral speech.
16082741|NCT02288585|Dietary Supplement|Plant sterols|Plant sterols
16082742|NCT02288585|Dietary Supplement|Placebo product|Placebo product
16082743|NCT02288572|Dietary Supplement|Lactobacillus plantarum PCS 26|Taking dietary supplement on a daily basis which corresponds to 1.000.000.000 CFU of Lactobacillus plantarum PCS 26 per day for 3 months.
16082744|NCT02288572|Dietary Supplement|Placebo|Taking dietary supplement on a daily basis for 3 months.
16082745|NCT02288559|Other|Sham|Sham injection will be administered as a matching intravitreal injection of lampalizumab.
16082746|NCT02288559|Drug|Lampalizumab|10 mg dose of lampalizumab administered intravitreally
16082747|NCT02288533|Device|real-tDCS|Participants will receive tDCS over the primary motor cortex bilaterally (M1). The excitability-enhancing anode electrode (saline-soaked sponge electrode - 16cm2) will be placed over the primary motor cortex, C3 and C4 (10/20 international EEG system). The excitability-diminishing cathode electrode will be placed over the supraorbital area. We will use the following stimulation parameters: intensity of 2 milliampere and for 40 minutes (10 consecutive sessions).
16082748|NCT02288507|Drug|Sorafenib|Sorafenib 400mg PO BID for Cohort 1, if 2 or more patients with dose-limiting toxicity toxicity (DLT), Chort -1 is sorafenib 200mg PO BID, if 2 or more patients with DLT, sorafenib 200mg PO daily
16082749|NCT02288507|Radiation|yttrium-90 radioembolization|Yttrium-90 SIR-Spheres microspheres are instilled through a catheter into a branch of the hepatic artery
16082750|NCT02288494|Other|stewart approach|Prospective study, for ICU patient with severe hypoalbuminemia < 20g/L, determining biological parameters from Stewart approach for acid base disorders (pH, SIDe, SIDa, SIG, Atot, PaCO2) before, and at 1hour, 2hours and 24 hours after a 200mL 20% human al Clinical parameters (respiratory, haemodynamic, neurologic) were also collected at the same times.
16082751|NCT02288481|Drug|TBA-354|TBA-354 supplied as a 20 mg /mL suspension and matching placebo suspension for oral administration.
16082752|NCT02288481|Other|Placebo|Placebo Suspension
16082753|NCT02288468|Device|Vercise™ Deep Brain Stimulation System|"The Vercise™ DBS System includes a Stimulator with DBS Leads for unilateral or bilateral stimulation. There are also DBS Extensions that allow the DBS Leads mounted in the skull to be extended to reach the Stimulator implanted near the clavicle.
~The rechargeable Vercise DBS System utilizes current steering across eight contacts per DBS Lead to provide precise positioning of stimulation. The Stimulator is controlled by a handheld Remote Control, and can be interfaced with a Clinician's Programmer using the Bionic Navigator™ Software. Periodically, the Stimulator battery must be replenished with an RF (radiofrequency) charging device provided in the Patient DBS Charging Kit."
16082754|NCT02288455|Device|GTU Artificial Urinary Sphincter|A totally implantable Artificial Urinary Sphincter (AUS) for the treatment of male Stress Urinary Incontinence (SUI)
16082755|NCT02288442|Other|exercise|Exercise training for 8 weeks (aerobic exercise, resistance training and inspiratory muscle training thrice a week)
16082756|NCT02288429|Drug|colistimethate sodium|
16082757|NCT02288416|Other|educational intervention|Undergo video-based intervention
16082758|NCT02288416|Other|questionnaire administration|Ancillary studies
16082759|NCT02288416|Other|quality-of-life assessment|Ancillary studies
16082760|NCT02288416|Other|Best Practice|
16082761|NCT02288403|Behavioral|Aerobic interval training|
16082762|NCT02288403|Behavioral|Continuous training|
16082763|NCT02288390|Procedure|Oral care in mechanically ventilated patients|Oral care comparing Chlorhexidine and toothbrush versus Miswak ( the twig of Arak, Salvadora perscia, tree)
16082764|NCT02288377|Drug|lanreotide|Patients will receive lanreotide 120 mg every 28 days until disease progression
16082765|NCT02288377|Drug|Placebo|
16082766|NCT02288364|Drug|1% Lidocaine|
16082767|NCT02288364|Drug|1% Lidocaine plus sodium bicarbonate|
16082768|NCT02288351|Other|Mix Nutrient Meal|Before Surgery: Subjects will have a visit where they will have a mixed nutrient stimulation test. They will be asked to fast for 12 hours prior to this visit (except water). During the visit they will drink an 8 ounce mixed nutrient liquid meal in 5 minute intervals over 20 minutes. During this visit a catheter will be placed in a vein in their arm for blood sample collections. A total of 50 ml of blood will be collected, (10 ml before drinking the mixed nutrient drink, at 30 minutes, at 60 minutes, at 90 minutes and 120 minutes after the mixed nutrient drink).
16082769|NCT02288351|Other|labs|Fasting Plasma Glucose (FPG) and insulin will be added to the standard pre-operative labs.
16082770|NCT02288351|Other|Biopsy|Intra-operatively: Subjects will undergo a standard laparoscopic Roux-en-Y Gastric Bypass (RYGB). During the surgery a 2cm tissue sample of the Roux limb will be taken by the doctor and frozen.
16082771|NCT02288351|Other|Second Mix Nutrient Meal|2 months post-operatively a second mixed nutrient stimulation test will be performed following the same process used pre-operatively.
16082772|NCT02288351|Other|Second biopsy|. Patients will also be scheduled to undergo a second upper endoscopy and a 2cm biopsy of the Roux limb will be taken by the doctor and frozen in liquid nitrogen.
16082773|NCT02288351|Device|PET/CT|Lastly, subjects will have a positron emission tomography/computed tomography (PET/CT) scan with Fluorodeoxyglucose (FDG) to evaluate the glucose in the Roux limb after surgery.
16082774|NCT02288338|Drug|1 (Lipitor®)|atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
16082775|NCT02288338|Drug|1 (Ezetrol®)|After 11days withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
16082776|NCT02288338|Drug|1 (Lipitor®, Ezetrol®)|After 11days withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
16082777|NCT02288338|Drug|2 (Ezetrol®)|ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
16082778|NCT02288338|Drug|2(Lipitor®, Ezetrol®)|After 11days withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
16082779|NCT02288338|Drug|2 (Lipitor®)|After 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
16082780|NCT02288338|Drug|3(Lipitor®, Ezetrol®)|atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
16082781|NCT02288338|Drug|3 (Lipitor®)|After 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
16082782|NCT02288338|Drug|3 (Ezetrol®)|After 11day withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
16082783|NCT02288338|Drug|4 (Lipitor®)|atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
16082784|NCT02288338|Drug|4(Lipitor®, Ezetrol®)|After 11days withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
16082785|NCT02288338|Drug|4 (Ezetrol®)|After 11day withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
16082786|NCT02288338|Drug|5 (Ezetrol®)|ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
16082787|NCT02288338|Drug|5 (Lipitor®)|After 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
16082788|NCT02288338|Drug|5 (Lipitor®, Ezetrol®)|After 11days withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
16082789|NCT02288338|Drug|6(Lipitor®, Ezetrol®)|atorvastatin calcium 40mg, Lipitor® 40mg and ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
16082790|NCT02288338|Drug|6 (Ezetrol®)|After 11days withdrawal period, ezetimibe 10mg, Ezetrol® 10mg will be administered to healthy volunteers during 7days
16082791|NCT02288338|Drug|6 (Lipitor®)|After 11day withdrawal period, atorvastatin calcium 40mg, Lipitor® 40mg will be administered to healthy volunteers during 7days
16082792|NCT02288325|Drug|Levomilnacipran ER|Levomilnacipran ER taken orally at 40, 80 or 120 mg once daily.
16082793|NCT02288325|Drug|Placebo|Dose-matched placebo taken orally once daily.
16082794|NCT02288312|Drug|BIA 2-093|
16082795|NCT02288299|Device|non invasive mechanical ventilation|instrumental increase of inspiratory capacity and cough
16082796|NCT02288286|Biological|2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 10-20 years old|freeze-dried rabies vaccine(MRC-5 cell) of 2.5IU/ml, 5 doses, 4 weeks interval
16082797|NCT02288286|Biological|2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 21-50 years old|freeze-dried rabies vaccine(MRC-5 cell) of 2.5IU/ml, 5 doses, 4 weeks interval
16082798|NCT02288286|Biological|2.5IU/ml rabies vaccine(MRC-5 cell) in humans aged 51-60 years old|freeze-dried rabies vaccine(MRC-5 cell) of 2.5IU/ml, 5 doses, 4 weeks interval
16082799|NCT02288286|Biological|2.5IU/ml rabies vaccine(vero cell) in humans aged 10-20 years old|freeze-dried rabies vaccine(vero cell) of 2.5IU/ml, 5 doses, 4 weeks interval
16082800|NCT02288286|Biological|2.5IU/ml rabies vaccine(vero cell) in humans aged 21-50 years old|freeze-dried rabies vaccine(vero cell) of 2.5IU/ml, 5 doses, 4 weeks interval
16082801|NCT02288286|Biological|2.5IU/ml rabies vaccine(vero cell) in humans aged 51-60 years old|freeze-dried rabies vaccine(vero cell) of 2.5IU/ml, 5 doses, 4 weeks interval
16082802|NCT02288273|Drug|Bydureon|Once weekly injection of 2mg bydureon (extended release exenatide) for 10 weeks.
16082803|NCT02288273|Drug|Placebo|Placebo
16082804|NCT02288247|Drug|Enzalutamide|Oral
16082805|NCT02288247|Drug|Docetaxel|intravenous infusion
16082806|NCT02288247|Drug|Prednisolone|Oral
16082807|NCT02288247|Drug|Placebo|Oral
16082808|NCT02288234|Drug|Vibativ|This is an observational study for patients who were already prescribed Vibativ.
16082809|NCT02288221|Other|Patient's answer with non pharmacological therapeutic|"Installation at patient's home of :
~aromatherapy
~music therapy
~cognitive training in multimedia application offering cognitive games"
16082810|NCT02288221|Other|Patient's answer without non pharmacological therapeutic|No installation at patient's home
16082811|NCT02288208|Drug|Antiviral Therapy (tenofovir or entecavir)|
16082812|NCT02288208|Drug|Birinapant|
16082813|NCT02288208|Drug|Placebo (for birinapant)|
16082814|NCT02288195|Drug|Oxaliplatin|130 mg/m² iv drip over 2 hours on day 1, repeated every 21 days.
16082815|NCT02288195|Drug|capecitabine|"825 mg/m² twice daily administered orally and concurrently with radiation therapy for 5 days per week.
~1000 mg/m² po twice daily on days 1- 14 repeated every 21 days in Group A and adjuvant chemotherapy in Group B."
16082816|NCT02288195|Radiation|Radiation|The total dosage was 46Gy consisted of 23 fractions of 2 Gy to clinical target volume without a boost dose and with the boost 4 Gy consisted of 2 fractions of 2 Gy to gross tumor volume by IMRT or 3D-CRT.
16082817|NCT02288182|Device|Straumann VivOss|Patients will receive Straumann VivOss for sinus augmentation.
16083579|NCT02282462|Other|Reg Pressure|Regulated Suction using the Thopaz+ digital chest drainage device
16082818|NCT02288182|Device|Geistlich Bio-Oss|Patients will receive Geistlich Bio-Oss for sinus augmentation.
16082819|NCT02288169|Behavioral|COPE|We propose to test a brief, effective intervention with outpatients in a cancer center, with the goal of teaching patients symptom management skills for self-identified symptoms of highest priority to patients. The proposed randomized clinical trial will test the efficacy of the COPE intervention with patients with symptoms of moderate to high intensity, distress, frequency or interference with their lives as a result of their cancer.
16082820|NCT02288169|Behavioral|Support/Attention Control|The attention control group will receive supportive visits from the research team at the cancer center and subsequent meetings during clinic visits plus 2 subsequent supportive telephone calls
16082821|NCT02288156|Drug|Capsaicin|via nasal spray
16082822|NCT02288156|Drug|placebo|via nasal spray
16082823|NCT02288143|Drug|COOL-COS|"Controlled ovarian stimulation will start on the second or third day of a menstrual cycle:
~Oral clomiphene citrate: 100 mg/day until the day of the triggering.
~Oral letrozole: 7.5 mg/day during the first 5 days of the controlled ovarian stimulation.
~hMG: 150 IU every other day beginning on the day 6 of the controlled ovarian stimulation.
~The triggering will be performed using urinary hCG (5,000 IU subcutaneous).
~1-2 days after the identification of one follicle ≥ 17 mm
~0-1 days after the identification of one follicle ≥ 19 mm."
16082824|NCT02288130|Drug|GnRHa|
16082825|NCT02288130|Drug|Ulipristal|
16082826|NCT02288104|Device|needle based confocal endomicroscopy|real time imaging of living tissue at microscopic scale, through a needle.
16082827|NCT02288091|Drug|Inosine|Twenty-five eligible subjects will receive inosine for 12 weeks (administered in the form of 500 mg capsules, 1 to 6 capsules a day for a total daily dose of up to 3 gm). The dose of inosine will be titrated to target urate levels of 7-8 mg/dL based on urate level measurement that will occur at Week 2, Week 4, Week 6, and Week 9 after Baseline.
16082828|NCT02288078|Other|General condition|Eastern Cooperative Oncology Group (ECOG) performance status (PS), height and body weight
16082829|NCT02288078|Other|Blood pressure|systolic blood pressure (SBP)/diastolic blood pressure (DBP)
16082830|NCT02288078|Other|Patient Reported Outcome|Incidence of fatigue or malaise (All grade of CTCAE ver. 4), anorexia, Brief fatigue inventory (BFI), FACT-C.
16082831|NCT02288078|Other|Clinical findings|"Blood and lymphatic system disorders: febrile neutropenia
~Gastrointestinal disorders: constipation, diarrhea, oral mucositis, nausea, and vomiting
~General disorders and administration site conditions: fatigue and malaise
~Immune system disorders: allergic reaction
~Metabolism and nutrition disorders: anorexia
~Nervous system disorders: dysgeusia and peripheral sensory neuropathy
~Respiratory, thoracic and mediastinal disorders: hoarseness (change of voice)
~Skin and subcutaneous tissue disorders: alopecia, skin hyperpigmentation, urticaria, and palmar-plantar erythrodysesthesia syndrome
~Vascular disorders: hypertension
~Symptomatic pancreatitis"
16082832|NCT02288078|Other|Hematology/blood chemistry|White blood cell count, absolute neutrophil count (stab + segmented), hemoglobin, platelet count, albumin, total bilirubin, aspartate aminotransferase(AST) (GOT), alanine aminotransferase (ALT) (GPT), serum creatinine, Na, K
16082833|NCT02288078|Other|Coagulation and fibrinolysis system|international normalized ratio (INR)
16082834|NCT02288078|Other|Urinalysis|Proteinuria (qualitative)
16082835|NCT02288078|Other|Medication check|Medicine taking situation (regorafenib, dexamethasone and placebo) determined by subject's diary at every courses
16082836|NCT02288078|Other|Adverse event|CTCAE ver.4.0
16082837|NCT02288078|Other|Thyroid function test|Thyroid-stimulating hormone (TSH), T4, and T3
16082838|NCT02288078|Other|Contrast-enhanced torso CT|It is recommended that CT images should be taken every 4 weeks (if possible) or at least every 8 weeks (allowable time window: ± 2 weeks), with the treatment phase taken into consideration.
16082839|NCT02288078|Other|Brain MRI|If any symptom of brain metastasis is suspected
16082840|NCT02288078|Drug|Dexamethasone|Capsule filled with dexamethasone and lactose
16082841|NCT02288078|Drug|Regorafenib|Film-coating tablet contains 40 mg of regorafenib
16082842|NCT02288078|Drug|Placebo|Capsule filled with lactose
16082843|NCT02288078|Drug|Proton pump inhibitor|PPIs (omeprazole, lansoprazole, etc, as not specified) for prevention of peptic ulcer
16082844|NCT02288065|Drug|sterile talc pleurodesis|medical thoracoscopy and talc pleurodesis. No specific device is studied.
16082845|NCT02288052|Behavioral|Writing program|6 weeks of at-home training (5days/week, 30minutes/day) using both pen-and-paper exercises and exercises on a writing tablet.
16082846|NCT02288052|Behavioral|Stretch & Relaxation program|6 weeks of at-home training (5days/week, 30minutes/day) using a DVD with exercises.
16082847|NCT02288039|Other|Social Identity goal-based Intervention|Phase 1: collaborative group discussion in order to establish what group members want to achieve by the end of their 8-week pulmonary rehabilitation programme. Phase 2: further collaborative group discussion with the emphasis on evaluating, monitoring, and providing feedback on goal attainment. Phase 3: focus group interviews with an emphasis on reviewing the goal setting process that patients have engaged with.
16082848|NCT02288013|Procedure|Closure of uterine incision at C section|Closure of uterine incision at Cesarean section
16082849|NCT02288000|Drug|Memantine|Memantine will be administered OS as of 10 mg- capsule one per day in the morning over 15 days.
16082850|NCT02288000|Drug|Placebo|the placebo will be administered OS as of 10 mg- capsule one per day in the morning over 15 days.
16082851|NCT02287987|Procedure|Clamp Robotic partial nephrectomy|Renal artery clamping during partial nephrectomy
16082852|NCT02287987|Procedure|Clampless Robotic partial nephrectomy|Robotic partial nephrectomy without renal artery clamping
16082853|NCT02287974|Drug|Stem cell infusion|Unique stem cell infusion of the randomized group
16082854|NCT02287961|Procedure|Standard proctologic examination|(with digital rectal examination and 2 anal swabs) at initial inclusion visit, M12 and M24 follow-up visits and if applicable M6 and M18 control visits
16082855|NCT02287961|Procedure|High resolution anoscopy|at initial inclusion visit, Month 12 and Month 24 follow-up visits and if applicable Month 6 and Month 18 control visits
16082856|NCT02287961|Procedure|Biopsy(ies) during High Resolution Anoscopy|only if lesion suggestive of AIN detected during High Resolution Anoscopy
16082857|NCT02287961|Procedure|High Resolution Anoscopy biannually|Only if high-grade lesion (ASC-H, HSIL ou AIN2/3)
16082858|NCT02287948|Device|Nintendo Wii Fit Balance Board|"Clinical and instrumental evaluations carry out on the same day.
~1) Instrumental evaluations
~All subjects (healthy + MS) will ask to perform the following tasks both on force platform and Wii Fit Balance Board:
~Open eyes, monopodalic balance for 20 seconds
~Closed eyes, monopodalic balance for 20 seconds
~Open eyes, balance on both feet for 60 seconds
~Closed eyes, balance on both feet for 60 seconds
~During trials subjects can leave arms in the most comfortable position they prefere
~Subjects will perform every task for 5 times; they can rest for 30 seconds between every trials."
16082859|NCT02287935|Procedure|Limberg flap|Patients were divided into two groups, group 1 were treated with Limberg flap technique (n= 37) . Two groups were compared with a statistical in terms of fluid collection, wound infection, flap edema, hematoma, partial wound separation, return to daily activities, pain score, completes healing time, painless seating and patient satisfactions
16082860|NCT02287935|Procedure|Karydakis procedure|Patients were divided into two groups, group 2 were treated with Karydakis flap (n= 34). Two groups were compared with a statistical in terms of fluid collection, wound infection, flap edema, hematoma, partial wound separation, return to daily activities, pain score, completes healing time, painless seating and patient satisfactions
16082861|NCT02287922|Biological|ALX-0061|
16082862|NCT02287922|Biological|Placebo|
16082863|NCT02287922|Biological|Tocilizumab|
16082864|NCT02287909|Drug|Clopidogrel|Swiching from ticagrelor to clopidogrel
16082865|NCT02287909|Drug|Ticagrelor|Continue treatment with ticagrelor
16082866|NCT02287896|Drug|ROLEDUMAB|See Arm description
16082867|NCT02287883|Other|Observational: Patient Activation and Engagement (PAE)|Observational: Patients receive care from clinics with either low or high levels of patient activation and engagement activities.
16082868|NCT02287870|Drug|Chloroprocaine|60 patients undergoing lower limb or lower abdominal surgery from three hospitals in China received 3% chloroprocaine.
16082869|NCT02287870|Drug|Lidocaine|60 patients undergoing lower limb or lower abdominal surgery from three hospitals in China received 2% lidocaine.
16082870|NCT02287857|Drug|Domestic Tenofovir Disoproxil Fumarate Tablets|1 Domestic Tenofovir Disoproxil Fumarate Tablets and 1 blank Tenofovir Disoproxil Fumarate Tablets of Gilead
16082871|NCT02287857|Drug|Tenofovir Disoproxil Fumarate Tablets of Gilead|1 blank Domestic Tenofovir Disoproxil Fumarate Tablets and 1Tenofovir Disoproxil Fumarate Tablets of Gilead
16082872|NCT02287844|Other|XOS|5 g of XOS everyday for 4 weeks.
16082873|NCT02287844|Other|INU-XOS|1 g of XOS and 3 g of inulin everyday for 4 weeks.
16082874|NCT02287844|Other|Placebo|6.64 g of maltodextrins everyday for 4 weeks.
16082875|NCT02287831|Biological|umbilical cord mesenchymal stem cells|patients were divided into 3 dose treatment groups (6.29 × 107,9.43 × 107 and 14.15 × 107 cells/m2). After 4 and 8 weeks, patients were injected the same number of cells.
16082876|NCT02287818|Drug|Placebo|Placebo twice daily from Day 1 to Week 12
16082877|NCT02287818|Drug|AC-201|AC-201 CR tablet 100 mg twice daily from Day 1 to Week 12
16082878|NCT02287818|Drug|Febuxostat|Febuxostat 40 mg once daily from Week 4 to Week 16; titration to 80 mg once daily at Week 8 as needed to achieve serum uric acid concentration <6 mg/dL
16082879|NCT02287805|Other|qualitative survey|
16082880|NCT02287805|Other|quantitative survey|
16082881|NCT02287792|Procedure|18-FDG PET/CT scan|Whole body 18-FDG PET/CT to assess cardiac and extracardiac complications in infective endocarditis
16082882|NCT02287779|Drug|SHP626|
16082883|NCT02287779|Drug|Placebo|
16082884|NCT02287753|Other|vascular occlusion test using Pediatric SomaSensor for INVOS 5100C|Pediatric SomaSensor for INVOS 5100C is attached at calf muscle and non-invasive blood pressure cuff is applied to ipsilateral thigh. VOT is performed as: after baseline oxygen saturation value is recorded, cuff pressure is rapidly increased to 30 mmHg over than systolic blood pressure. After 3 minutes of ischemic time, cuff pressure is rapidly decreased. It is performed at 3 time periods : before start of operation, during cardiopulmonary bypass, and after weaning from cardiopulmonary bypass.
16082885|NCT02287740|Behavioral|Tai Ji Quan: Moving for Better Balance|The protocol involves a core 8-form routine training with built-in variations and a subroutine of integrated therapeutic movements.
16082886|NCT02287740|Behavioral|Multimodal Exercise|The protocol involves a multi-modality program that involves aerobic, strength, balance, and flexibility exercises.
16082887|NCT02287740|Behavioral|Stretching|The protocol represents a minimum standard of practice for exercises for older adults with activities consisting primarily of seated exercises accompanied by breathing, stretching, and relaxation.
16082888|NCT02287727|Other|Laboratory Biomarker Analysis|Correlative studies
16082889|NCT02287727|Drug|Regorafenib|Given PO
16082890|NCT02287714|Procedure|Instep without gastrocnemius recession|Patient will receive an instep plantar fascial release without gastrocnemius recession.
16082891|NCT02287714|Procedure|Instep with gastrocnemius recession|Patient will receive an instep plantar fascial release as well as gastrocnemius recession.
16082892|NCT02287701|Procedure|PET/MRI|Simultaneous PET/MRI (3T system)
16082893|NCT02287688|Biological|Meningococcal quadrivalent CRM-197 conjugate vaccine|This study is strictly observational. Decisions of vaccination are made by health care providers.
16082894|NCT02287675|Drug|Lymphoseek|Subjects will receive a single intradermal injection of Lymphoseek followed by SPECT imaging conducted in two phases: initial sequential planar imaging at 30 to 60 second intervals for the first 60 minutes and repeated at 90 minutes and 120 minutes, as indicated, for identification of the SLN followed by SPECT/CT for higher resolution imaging in transaxial, coronal, and sagittal planes. Subjects will then proceed to surgery for lymphatic mapping. Lymphoseek positivity will be based upon radioactivity counts derived from the application of the handheld gamma probe ex vivo. Tumor resection or mastectomy will be performed according to standard procedures.
16082942|NCT02287337|Procedure|Manipulation|High velocity low amplitude thrust joint manipulation to cervical spine facet joints
16082943|NCT02287337|Procedure|Exercise|Therapeutic exercises to the cervical, thoracic and scapular musculature
16082944|NCT02287324|Procedure|Manipulation|
16082945|NCT02287324|Procedure|Manual Contact|
16083146|NCT02285725|Procedure|Microdrilling Surgery|All patients will undergo an arthroscopic surgical procedure in which small holes are drilled throughout the areas of damaged cartilage (standard of care)
16082895|NCT02287675|Drug|Sulfur Colloid|Subjects will receive a single intradermal injection of 99mTc-SC followed by SPECT imaging conducted in two phases: initial sequential planar imaging at 30 to 60 second intervals for the first 60 minutes and repeated at 90 minutes and 120 minutes, as indicated, for identification of the SLN followed by SPECT/CT for higher resolution imaging in transaxial, coronal, and sagittal planes. Subjects will then proceed to surgery for lymphatic mapping. 99mTc-SC positivity will be based upon radioactivity counts derived from the application of the handheld gamma probe ex vivo. Tumor resection or mastectomy will be performed according to standard procedures.
16082896|NCT02287662|Other|Vancouver 3M Clinical Pathway|
16082897|NCT02287649|Other|blood sample|
16082898|NCT02287636|Radiation|fludeoxyglucose F 18|Undergo fludeoxyglucose F 18 PET/CT
16082899|NCT02287636|Procedure|positron emission tomography|Undergo fludeoxyglucose F 18 PET/CT
16082900|NCT02287636|Procedure|computed tomography|Undergo fludeoxyglucose F 18 PET/CT
16082901|NCT02287636|Procedure|positron emission tomography|Undergo PET/MRI
16082902|NCT02287636|Procedure|magnetic resonance imaging|Undergo PET/MRI
16082903|NCT02287623|Drug|liposomal bupivacaine|patients will receive a tap with liposomal bupivacaine
16082904|NCT02287623|Drug|bupivacaine|patients will receive a tap with bupivacaine
16082905|NCT02287610|Drug|RAYOS (delayed-release prednisone)|Physicians may prescribe any dosage of RAYOS based on what is appropriate for the treatment of the patient's condition as determined by performing standard of care assessments.
16082906|NCT02287584|Drug|DSP-5423P Placebo|DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily
16082907|NCT02287584|Drug|DSP-5423P 40mg|DSP-5423P 40mg was applied to the subject's back, chest, or abdomen once daily
16082908|NCT02287584|Drug|DSP-5423P 80mg|DSP-5423P 80mg was applied to the subject's back, chest, or abdomen once daily
16082909|NCT02287584|Drug|DSP-5423P Placebo-to-Flex|"DSP-5423P Placebo:
~DSP-5423P Placebo was applied to the subject's back, chest, or abdomen once daily
~DSP-5423P Flex:
~DSP-5423P 20mg, 60mg or 80mg was applied to the subject's back, chest, or abdomen once daily"
16082910|NCT02287584|Drug|DSP-5423P Active-to-Flex|"DSP-5423P Active:
~DSP-5423P 40mg or 80mg was applied to the subject's back, chest, or abdomen once daily
~DSP-5423P Flex:
~DSP-5423P 20mg, 60mg or 80mg was applied to the subject's back, chest, or abdomen once daily"
16082911|NCT02287571|Device|Derotation splint|This group is the actual intervention group.
16082912|NCT02287571|Device|elastic bandage|This group is the routine treatment (control) valid in the clinical practice.
16082913|NCT02287558|Drug|Pomalidomide|
16082914|NCT02287545|Procedure|trabeculectomy|Standard trabeculectomy with the use of antimetabolites (mitomycin C) for glaucoma patients with insufficient intraocular pressure (IOP) control taking maximally tolerated IOP-reducing medication, visual field progression despite maximally tolerated IOP-reducing medication, adverse events because of maximally tolerated IOP-reducing medication or nono.compliance.
16082915|NCT02287532|Device|DIABEO software|DIABEO is an electronic diary system incorporating an immediate automatic aid to calculating the insulin dose according to the prescription given by the doctor, and a data processing, automated analysis message and secure internet data transfer system. DIABEO software could be combined with remote paramedical monitoring of data (telemonitoring)
16082916|NCT02287519|Behavioral|Group Session|
16082917|NCT02287519|Behavioral|Telephone Coaching Session|
16082918|NCT02287519|Behavioral|Webinar|
16082919|NCT02287506|Other|Optimised Diagnostic Strategy|(ODS) based on integrating Clinical information (a validated clinical probability model), Biomarkers (GAD, IA2 and ZnT8 autoantibodies) and Genetic testing for MODY
16082920|NCT02287493|Other|Pharmacokinetic Analysis|
16082921|NCT02287480|Biological|VSV-ZEBOV|See arm/group descriptions.
16082922|NCT02287467|Biological|Intravenous hyperimmune immunoglobulin (IVIG)|Administered intravenously (IV) at a dose of 0.25 g/kg (up to a maximum of 24.75 g, corresponding to approximately 100 kg actual body weight)
16082923|NCT02287467|Biological|Placebo for IVIG|Administered IV as 500 mL of normal saline
16082924|NCT02287454|Other|cognitive remediation program: REHACOP|Specifically, REHACOP group remediation with MS patients consisted of: four weeks training attention (sustained, selective, alternating and divided attention); three weeks focused on learning and memory (the stimulation of verbal and visual memory was combined with learning and compensatory strategies, working memory was also trained); three weeks exercising executive functioning (development, planning and attainment of objectives); three weeks focused on language (verbal fluency, syntax, grammar, vocabulary and comprehension); and one week training social cognition (social reasoning, theory of mind and moral dilemmas).
16082925|NCT02287441|Other|Tomato|Tomato Products (tomato)
16082926|NCT02287441|Other|Raw|Vegetables Prepared Raw (raw).
16082927|NCT02287428|Radiation|Radiation Therapy|Standard radiotherapy (approximately 60 Gy over 6 weeks)
16082928|NCT02287428|Biological|Personalized NeoAntigen Vaccine|NeoVax will be administered on an individual basis using a dosing schedule that incorporates both priming and boost phases.
16082929|NCT02287428|Drug|Pembrolizumab|Pembrolizumab will be administered every 3 weeks at a flat dose of 200 mg intravenously. Pembrolizumab should be administered as a 30 minute IV infusion (Pembrolizumab treatment cycle intervals may be increased due to toxicity per protocol).
16082930|NCT02287428|Drug|Temozolomide|Concurrent Temozolomide (TMZ) = 75 mg/m2/day for 6 weeks, administered with XRT
16082931|NCT02287428|Drug|Temozolomide|Adjuvant Temozolomide (TMZ) = 150 mg/m2/day on days 1-5 of each 28-day cycle for up to 6 adjuvant cycles
16082932|NCT02287415|Drug|BIA 2-093|
16082933|NCT02287415|Drug|Warfarin|
16082934|NCT02287402|Drug|AO-128|AO-128 tablet
16082935|NCT02287389|Device|balloon dilation|
16082936|NCT02287389|Procedure|cryotherapy|
16082937|NCT02287389|Procedure|spiculiform electrosurgery|
16082938|NCT02287389|Drug|mitomycin C|
16082939|NCT02287376|Drug|Diclofenac Potassium for Oral Solution|NSAID
16082940|NCT02287363|Other|No intervention involved|No interventions will be involved since it is an observational study
16082941|NCT02287350|Drug|diclofenac potassium oral solution|Administration of diclofenac potassium oral solution, taken by mouth, as needed for mild to moderate acute pain.
16083130|NCT02285816|Biological|AdMA3|AdMA3: Priming component of Oncolytic Vaccine
16082946|NCT02287311|Biological|MABEL CTLs|"Dose escalation:
~DL1:2x10^7 cells/m2+2x10^7 cells/m2
~DL2:2x10^7cells/m2+5x10^7 cells/m2
~DL3:5x10^7 cells/m2+1x10^8 cells/m2
~*Doses are based on total CD3+cells/m2
~Patients with active disease that have apparent clinical benefit at the 8 wk post 1st infusion (6 wks after 2nd infusion) or subsequent evaluations may receive up to 6 additional doses of CTLs at intervals at least 6 wks apart, each of which will consist of the same cell number as their second injection or below the original dose if there is not enough product available for the original dose. Patients may receive lymphodepleting chemotherapy (Cy/Flu) before additional infusions. Patients cannot receive additional doses until the initial safety profile is completed at 6 wks following the second infusion."
16082947|NCT02287311|Drug|Cyclophosphamide|"If the patient's level of circulating T cells is relatively high, s/he may require treatment with cyclophosphamide (Cytoxan) and Fludarabine before s/he receives MABEL CTLs.
~3 daily doses of cyclophosphamide (Cy: 500 mg/m2/day) together with fludarabine (Flu: 30 mg/m2) to induce lymphopenia, finishing at least 24 hours before CTL infusion."
16082948|NCT02287311|Drug|Fludarabine|"If the patient's level of circulating T cells is relatively high, s/he may require treatment with cyclophosphamide and fludarabine before s/he receives MABEL CTLs.
~3 daily doses of cyclophosphamide (Cy: 500 mg/m2/day) together with fludarabine (Flu: 30 mg/m2) to induce lymphopenia, finishing at least 24 hours before CTL infusion."
16082949|NCT02287298|Procedure|TRIPLE COMBINATION THERAPY|TREATMENT WITH BEVACIZUMAB, DEXAMETHASONE AND PHOTODYNAMIC THERAPY
16082950|NCT02287285|Drug|Exendin9|Dosed at 600 pmol/kg/min for 210 minutes.
16082953|NCT02287259|Drug|olanzapine|
16082954|NCT02287259|Drug|lithium|
16082955|NCT02287246|Drug|Extended-Release liposomal bupivacaine (Exparel)|20mL
16082956|NCT02287246|Drug|Normal saline|20mL
16082957|NCT02287233|Drug|Venetoclax|Venetoclax will be taken orally once daily on Days 1 through 28 of each cycle. This is a dose escalation study, therefore the dose of venetoclax will change.
16082958|NCT02287233|Drug|Cytarabine|Cytarabine will be administered subcutaneously on Days 1 to 10 of each 28-day cycle.
16082959|NCT02287220|Device|Non-Contact Oximetry|Video Record subject when subjected to small amounts of near infrared light
16082960|NCT02287207|Device|transcranial direct current stimulation (tDCS)|
16082961|NCT02287194|Device|SpyGlass|The SpyGlass Direct Visualization System is an integrated product platform that is designed to provide a direct intraluminal view of the biliary duct system and direct therapeutic devices.
16082962|NCT02287181|Drug|Remifentanil|short acting opiate
16082963|NCT02287181|Drug|Propofol|hypnotic drug
16082964|NCT02287181|Other|Bispectral index|electroencephalograph
16082965|NCT02287168|Procedure|pre-gastrectomy peritoneal washing cytology|sampling of peritoneal washing fluid before gastrectomy
16082966|NCT02287168|Procedure|post-gastrectomy peritoneal washing cytology|sampling of peritoneal washing fluid after gastrectomy
16082967|NCT02287168|Procedure|post-lavage peritoneal washing cytology|sampling of peritoneal washing fluid after peritoneal lavage
16082968|NCT02287155|Behavioral|occupation based health promotion|"The description of the intervention is provided in the detailed description of the study."
16082969|NCT02287142|Procedure|Brachial plexus nerve block|All arms of the study comparing the three different blocks are receiving the same single injection bolus of ropivacaine 0.5% prior to surgery. We will then record and compare pain scores in PACU and opioid requirement.
16082970|NCT02287129|Drug|Oxaliplatin|130 mg/m2
16082971|NCT02287129|Drug|Epirubicin|50 mg/m2
16082972|NCT02287129|Drug|Capecitabine|625 mg/m2
16082973|NCT02287129|Drug|5-FU|200 mg/m2
16082974|NCT02287129|Drug|Carboplatin|2 mg/ml min
16082975|NCT02287129|Drug|Paclitaxel|50 mg/m2
16082976|NCT02287129|Radiation|radiation|total dosage 41,4 Gy
16082977|NCT02287129|Procedure|Biopsy|translational analysis
16082978|NCT02287116|Device|Easy Flow system and INCA® nasal cannulae set|
16082979|NCT02287103|Other|Skipping Breakfast|NoB: The patients will omit the breakfast, will continue the overnight fast until lunch, then will eat only lunch and dinner.
16082980|NCT02287103|Other|Eating Breakfast|YesB: will eat all three meals
16082981|NCT02287090|Other|Observational Cohort|
16082982|NCT02287077|Procedure|Umbilical Cord Milking|At birth, neonate will be held below the level of placenta and umbilical cord will be milked 3 times before clamping the cord.
16082983|NCT02287064|Drug|Intravenous Immune Globulin (IVIG)|"IVIG will be infused over a course of five days in the form of GAMMAGARD LIQUID 10% solution, available from Baxter. For neurological and autoimmune diseases 2 grams per kilogram of body weight is implemented for three months over a five day course once a month.
~There is very limited reliable dose ranging data for IVIG in the treatment of any condition, and most dosing has been empiric. In our experience, we have empirically observed a more potent immunomodulatory effect from induction dose IVIG (2 g/kg) continued each month, than with the booster dose maintenance dose of 1gm/kg. Though there is no category one evidence to support this practice, neither is there such evidence to refute it. Additionally, results from previous trials of IVIG in SCAs show this dosage to be relatively safe and effective at this rate of infusion"
16082984|NCT02287038|Drug|Atomoxetine 80 MG|Subjects will be randomized and assigned by the study investigator into crossover group 1 (Atomoxetine 80mg at Phase I, then placebo at Phase II) or group 2 (placebo at Phase I, then Atomoxetine at Phase II) with both placebo and medication administered through pharmacy. There was a 1-week interval between the two phases.
16082985|NCT02287025|Drug|Regorafenib (Stivarga, BAY73-4506)|Dose(s) 160 mg tablet (4 tablets per day at 40 mg) daily for 3 weeks on / 1 week off
16082986|NCT02287025|Other|iPAD application|Investigators were supported with enhanced drug-specific information via an iPad application (SMART).
16082987|NCT02287025|Other|Bayer specialist|The treating investigator will have access to the prescribing information and have ability to consult a Bayer specialist, should questions arise.
16083131|NCT02285803|Device|transcranial direct current stimulation (tDCS)|
16083132|NCT02285790|Device|Reflectance confocal microscopy|
16082988|NCT02287012|Other|Time/Motion evaluation of actual apheresis|The actual apheresis events will be measured in consecutive patients scheduled to be candidates for peripheral blood stem mobilization in the apheresis area of the hospital. Each apheresis will be considered as one event . Should the patient receive more than 1 apheresis, each apheresis will be considered as one different event.
16082989|NCT02286999|Drug|B. infantis|Infants in the intervention group will receive two doses of B. infantis on Day 7 and Day 14 of life, while infants in the placebo group will be dosed with placebo on Day 7 and Day 14
16082990|NCT02286999|Drug|Placebo|
16082991|NCT02286986|Drug|Cannabidiol|
16082992|NCT02286973|Drug|Tranexamic Acid|
16082993|NCT02286960|Drug|Steroid|A short 4 day course is administered to the first group of patients with voice disorders before the initiation of voice therapy.
16082994|NCT02286960|Dietary Supplement|Lactose Pills|4 day course 2 x 20mg per da
16082995|NCT02286947|Drug|Eteplirsen|Eteplirsen solution for IV infusion
16082996|NCT02286934|Drug|Carvedilol|"Day 1 to 3 : Carvedilol 12.5 mg qd
~Day 4 to 8 : Carvedilol 25 mg qd
~Day 9 to 11 : Carvedilol 12.5 mg qd"
16082997|NCT02286934|Other|Isoproterenol Sensitivity Test|Day 0, 1, 8 : Isoproterenol Sensitivity Test
16082998|NCT02286921|Drug|Testosterone cypionate|Depo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. Depo-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
16082999|NCT02286921|Drug|Enzalutamide|Enzalutamide is a white crystalline non-hygroscopic solid. It is practically insoluble in water. Enzalutamide is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides. The inactive ingredients are caprylocaproyl polyoxylglycerides, butylated hydroxyanisole, butylated hydroxytoluene, gelatin, sorbitol sorbitan solution, glycerin, purified water, titanium dioxide, and black iron oxide.
16083000|NCT02286921|Drug|Testosterone Enanthate|Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative.
16083001|NCT02286895|Biological|pentavalent rotavirus vaccine (PRV)|Each two-ml dose contains 5 live human-bovine reassortant rotaviruses with a minimum of 2.0 - 2.8 x 106 infectious units (IU) per reassortant, depending on the serotype, and not greater than 116 x 106 IU per aggregate dose. Each vaccine dose contains sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, and trace amounts of fetal bovine serum. RotaTeq contains no preservatives. RotaTeq is a pale yellow clear liquid that may have a pink tint. This vaccine was administered orally.
16083002|NCT02286895|Biological|measles vaccine (MV)|A lyophilized vaccine in a pack containing one vial plus one ampoule of sterile water for injection. After reconstitution, each 0.5 ml/dose of MV contains active substances not less than 1000 units of 50% cell culture infectious doses (CCID50) of MV. Measles Vaccine Live Attenuated virus is propagated on Human Diploid Cells. This MV is currently part of the local EPI program in Mali. This vaccine was administered subcutaneously to the right deltoid.
16083003|NCT02286895|Biological|yellow fever vaccine (YFV)|A freeze-dried live attenuated yellow fever virus of the 17D strain for injection. After reconstitution, one dose (0.5 ml) contains active substances not less than 1000 units of 50% lethal doses (LD50) of yellow fever virus. This YFV is currently part of the local EPI program in Mali. This vaccine was administered intramuscularly to the left deltoid.
16083004|NCT02286895|Biological|meningitis conjugate vaccine (PsA-TT-5μg)|A meningococcal A vaccine, with meningococcal A polysaccharide (PsA) conjugated to the carrier protein, tetanus toxoid (TT). After reconstitution, one dose (0.5 ml) contains 5μg meningococcal A polysaccharide and 5-16 μg tetanus toxoid as a carrier protein. PsA-TT-5μg was considered experimental at the initiation of this study, but received approval from the WHO for infants on 30 December 2014. For all participants enrolled January 1st, 2015 or later, PsA-TT-5μg was not included in Group A or Group B, due to its December 2014 expiration date. This vaccine was administered intramuscularly to the right thigh.
16083005|NCT02286882|Drug|PF-06409577 or Placebo|PF-06409577or placebo will be administered as an extemporaneously prepared suspension once in each cohort
16083006|NCT02286869|Procedure|Three different mechanical ventilation modes|patients are randomly assigned to every arm. Baseline is the period immediatly before the study phase. The study phase is the sequence of three consecutive trials of different modes of mechanical ventilation. Every trial lasts 30 min plus 10 min of acclimation.
16083007|NCT02286856|Behavioral|diet intervention|The dietary intervention implies optimizing the diet based on individually calculated energy and protein requirements, while for remaining nutrients advise in line with recommended daily amounts (RDA) will be provided. This nutrients will be translated to food products and lifestyle advice is added. Individual diet counseling will be part of the intervention to improve compliance.
16083008|NCT02286843|Radiation|89Zr-trastuzumab|
16083009|NCT02286843|Device|PET/CT scan|
16083010|NCT02286843|Radiation|89Zr-pertuzumab|
16083011|NCT02286830|Drug|Zoledronic acid|Zoledronic acid will be given to all participants for two years. Then patients will be randomized to A receive 2 more years of treatment or B stop treatment.
16083012|NCT02286817|Drug|NFC-1|Single-dose, open label administration to assess safety, tolerability, and pharmacokinetics in adolescents with ADHD and continuous daily administration for four weeks with weekly escalation to evaluate safety, tolerability, and impact on ADHD severity.
16083013|NCT02286804|Device|Ultherapy|Micro-focused ultrasound energy delivered below the surface of the skin
16083014|NCT02286791|Behavioral|Mindful Awareness Program|For Mindful Awareness Program, 40-minutes weekly sessions for 12 weeks, followed by 40-minutes monthly for 6 months. The mindful awareness practice techniques to be taught to the elderly include: (1) mindfulness of the senses practice; (2) the body scan practice; (3) walking meditation practice; (4) 'movement nature meant' practice; and (5) visuo-motor limb tasks
16083133|NCT02285790|Procedure|Punch biopsy|
16083134|NCT02285790|Procedure|Surgical excision|Excision of the suspected basal cell carcinoma lesion under local anesthetics
16083265|NCT02284815|Dietary Supplement|Glutenfree diet|Newly diagnosed children could choose glutenfree diet
16083015|NCT02286791|Behavioral|Health Education Program|"For the Health Education Program, weekly sessions of 40 minutes for 12 weeks, followed by monthly sessions of 40 minutes for 6 months.
~Week 1: Diabetes Mellitus Week 2: Hypertension Week 3: Home Safety Week 4: Medications Week 5: Diet Week 6: Depression Week 7: Dementia Week 8: Anxiety Week 9: Sleep Week 10: Exercise Week 11: Coping with bereavement Week 12: Social support"
16083016|NCT02286778|Dietary Supplement|Acetogenins|Acetogenins BID for 12 months
16083017|NCT02286778|Dietary Supplement|Placebo|
16083018|NCT02286765|Device|Ulthera System treatment|Micro-focused ultrasound energy delivered below the surface of the skin
16083019|NCT02286752|Drug|Neostigmine|for reversal of neuromuscular block: 0,05 mg kg-1 neostigmine + 0,025 mg kg-1 atropine
16083020|NCT02286752|Drug|sugammadex|for reversal of neuromuscular block: sugammadex 2 mg kg-1
16083021|NCT02286739|Device|"TKA with Verasense"|VERASENSE replaces the standard tibial trial inserts and is embedded with microelectronics and sensors to provide surgeons with real-time knee kinetic data. The data is wirelessly transmitted to a graphic display (VERASENSE Knee Application), allowing surgeons to quantify and assess soft tissue intercompartmental loads throughout the range of motion. The VERASENSE sensor is not an investigational device. OrthoSensor, Inc., received FDA 510K clearance in 2009. The indication for use is a tool for adjustment of the femoral knee implant to reduce instability from flexion gap asymmetry. The VERASENSE sensor is sterile and single patient use.
16083022|NCT02286739|Procedure|"TKA without Verasense"|TKA will be performed manually without the use of Verasense
16083023|NCT02286726|Other|Laboratory Biomarker Analysis|Correlative studies
16083024|NCT02286726|Drug|Liposome-encapsulated Daunorubicin-Cytarabine|Given IV
16083025|NCT02286713|Behavioral|Patient Decision Aid|Participants will receive study materials including a video to watch about lung cancer screening
16083026|NCT02286713|Behavioral|Standard Educational Information|Participants will receive study materials including a booklet to read about lung cancer screening.
16083027|NCT02286713|Behavioral|Follow-Up Assessments: Questionnaires|Follow up questions administered via phone and/or mail at 1-week, 3-month, and 6-month
16083028|NCT02286700|Drug|Desonide Cream|Study cream randomized and distributed to subjects, applied twice daily for 3 weeks and evaluated ability to reduce atopic dermatitis symptoms.
16083029|NCT02286700|Other|Amino Acid Moisturizing Cream|Study cream randomized and distributed to subjects, applied twice daily for 3 weeks and evaluated ability to reduce atopic dermatitis symptoms.
16083030|NCT02286687|Other|Laboratory Biomarker Analysis|Correlative studies
16083031|NCT02286687|Other|Pharmacological Study|Correlative studies
16083032|NCT02286687|Drug|Talazoparib|Given PO
16083033|NCT02286674|Other|Tablet (Audio/Visual Device)|Subjects will be given a tablet to use before surgery
16083034|NCT02286661|Procedure|Casting (long arm)|Casting using plaster of paris after closed reduction of distal radius fracture
16083035|NCT02286661|Procedure|Casting (short arm)|
16083036|NCT02286648|Drug|Formocresol|pulpotomy with formocresol
16083037|NCT02286648|Drug|Mineral Trioxide Aggregate|pulpotomy with MTA
16083038|NCT02286635|Drug|Deflazacort and rifampin|Deflazacort, a glucocorticoid with anti-inflammatory and immunosuppressive effects, is used in treating a variety of diseases. Pharmacologically it is an inactive pro-drug which is metabolized completely and rapidly to the active drug 21-desacetyldeflazacort (21 desacetyl-DFZ). The elimination of this metabolite is primarily via the urine in humans. Its potency is approximately 70 to 90% of prednisone and 6 mg of deflazacort has approximately the same anti-inflammatory potency as 5 mg of prednisolone or prednisone. Rifampin is a potent inducer of drug metabolism by inducing a variety of hepatic and intestinal CYP enzymes, especially CYP3A4. Rifampin is a semi-synthetic antibiotic.
16083039|NCT02286635|Drug|Deflazacort and Clarithromycin|Deflazacort, a glucocorticoid with anti-inflammatory and immunosuppressive effects. It is an inactive pro-drug which is metabolized completely and rapidly to the active drug 21 desacetyl-DFZ. The elimination of this metabolite is primarily via the urine in humans. Its potency is approximately 70 to 90% of prednisone. Clarithromycin is a semi-synthetic macrolide antibiotic. Clarithromycin is active in vitro against a variety of aerobic and anaerobic gram-positive and gram-negative bacteria as well as most mycobacterium avium complex (MAC) bacteria. Additionally, the 14-OH clarithromycin metabolite also has clinically significant antimicrobial activity. Clarithromycin is indicated for the treatment of mild to moderate infections such as pharyngitis/tonsillitis.
16083040|NCT02286622|Drug|Deflazacort|Deflazacort, a glucocorticoid with anti-inflammatory and immunosuppressive effects, is used in treating a variety of diseases. Pharmacologically it is an inactive pro-drug which is metabolized immediately to the active metabolite 21-desacetyl-DFZ. The elimination of this metabolite is primarily via the urine in humans. Its potency is approximately 70 to 90% of prednisone and 6 mg of deflazacort has approximately the same anti-inflammatory potency as 5 mg of prednisolone or prednisone
16083041|NCT02286609|Drug|Deflazacort|Deflazacort, a glucocorticoid with anti-inflammatory and immunosuppressive effects, is used in treating a variety of diseases. Pharmacologically it is an inactive pro-drug which is metabolized immediately to the active metabolite, 21 desacetyl-DFZ. The elimination of this metabolite is primarily via the urine in humans. Its potency is approximately 70 to 90% of prednisone and 6 mg of deflazacort has approximately the same anti-inflammatory potency as 5 mg of prednisolone or prednisone.
16083042|NCT02286596|Device|heparin-induced extracorporeal LDL precipitation|Lipid apheresis for 3 hours
16083043|NCT02286596|Device|dextran sulfate adsorption|Lipid apheresis for 3 hours
16083044|NCT02286583|Device|Microwave Thermography RTM-01-RES|Divide the breast into 3 circles start from the nipple with 1 cm increase in the circle diameter. Divide this circle into 8 points. This makes us detect 24 points in addition to the nipple as fixed point and the tail of the breast as separate point giving total of 26 points.
16083045|NCT02286570|Device|Glidescope|videolaryngoscope used for endotracheal intubation
16083046|NCT02286570|Device|Airtraq|videolaryngoscope used for endotracheal intubation
16083047|NCT02286570|Device|Fastrach|intubating laryngeal mask airway used for blind endotracheal intubation
16083048|NCT02286557|Drug|Methelphenidate|All participants will undergo 4 weeks of treatment with Methelphenidate and 4 weeks of placebo
16083049|NCT02286557|Drug|Placebo|
16083135|NCT02285777|Biological|Meningococcal ABCWY|One dose administered intramuscularly in the deltoid area of a non-dominant arm at Month 6 (Visit 1)
16083050|NCT02286544|Biological|Salmonella typhi vaccine (Typhim Vi®)|A peripheral venous catheter will be inserted. This catheter will be used to collect blood sample during the study day. In addition, peripheral oxygen saturation will be measured by pulse oximetry. After baseline venous blood samples have been collected, all study participants will receive 0.5 mL of the Salmonella typhi vaccine as an intramuscular injection (Typhim Vi®, Sanofi Pasteur MSD, injection solution 25 microgram/0.5 mL) Venous blood samples will be collected at 3, 6 and 8 hours after baseline. After the 8-hour blood sampling, the peripheral venous catheter will be removed and the study day ended.
16083051|NCT02286544|Drug|Oxygen (Oxymask®)|"As in arm 1. Half an hour after vaccination is administered, oxygen treatment will be initiated at 6 L/min via Oxymask® and continued for 6 hours. During oxygen treatment peripheral oxygen saturation will be measured by pulsoximetry.
~Venous blood samples will be collected at 3, 6 and 8 hours after baseline. After the 8-hour blood sampling, the peripheral venous catheter will be removed and the study day ended."
16083052|NCT02286544|Drug|Atorvastatin|As in arm 1. Half an hour after vaccination is administered, oxygen treatment will be initiated at 6 L/min via Oxymask® and continued for 6 hours. During oxygen treatment peripheral oxygen saturation will be measured by pulsoximetry. A single dose of Atorvastatin 80 mg will be given immediately prior to start of oxygen. Venous blood samples will be collected at 3, 6 and 8 hours after baseline. After the 8-hour blood sampling, the peripheral venous catheter will be removed and the study day ended.
16083053|NCT02286531|Drug|O-(2[18F]FLUOROETHYL)-L-TYROSINE|Patient 0.1 mCi / kg (maximum 185 MBq) of FET will be injected through the venous catheter. At the same time, will trigger a PET 3D dynamic acquisition of 60 minutes (5 pictures 1 minute and 11 images of 5 minutes)
16083054|NCT02286518|Drug|TAK-114 10 mg capsule|
16083055|NCT02286518|Drug|TAK-114 matched placebo|
16083056|NCT02286505|Device|Brain Morphometry|Quantitative, automated reading of hippocampal volume from MRI scans, complemented by a general measure of brain atrophy, in addition to standard neuroradiological report.
16083057|NCT02286505|Other|Standard radiological assessment|Standard neuroradiological report produced by qualitative examination of structural MRI scan by trained neuroradiologist.
16083058|NCT02286492|Drug|TAS-102|At a dose of 35 mg/m2 administered orally twice daily for 5 days a week with 2 days rest for 14 days, followed by a 14-day rest (1 treatment cycle)
16083059|NCT02286479|Procedure|Incision and Drainage|In the incision and drainage group, the abscesses are incised, irrigated by sterile solutions and drained conventionally.
16083060|NCT02286479|Procedure|Loop drainage|In the loop drainage group, two small incision are made on each side of abscess. The pus are drained and septations are seperated by a forceps. Abscess cavitary irrigated by sterile solution. Sterile, non-powder, non-latex surgical gloves cuff is inserted in one incision and taken out from the other insicion. Then two tips of cuff are tied loosely.
16083061|NCT02286466|Behavioral|Health Education Program|Participants in the control group will receive a health education program using a tablet computer identical to the intervention group. The content of this program is adapted from a health education intervention used as the control condition for a cognitive behavioral stress and affect management intervention in a NIH-funded randomized controlled trial of a quality of life intervention for patients with advanced prostate cancer (R21CA102761, PI: Penedo). The program consists of the same number of sessions as the intervention group and includes general information about health and well-being. Specifically, control participants will learn information about topics such as healthy eating, exercise, memory and cognition, and side effects in the context of a cancer diagnosis and treatment.
16083062|NCT02286466|Behavioral|CBT Mobile Application|The CBT intervention is brief, consisting of 6 modules lasting approximately 30 minutes each. Sessions focus on skills for relaxation, coping with cancer-related worries, as well as activity planning and pacing. Prior to starting the program, a trained research assistant will meet with participants in a private office setting to orient them to the software and instruct them on the use of the mobile tablet device. Once patients are comfortable with the functions and features of the mobile app, they will be encouraged to self-administer the intervention on their study-issued tablet at home and during their regularly scheduled oncology visits, for example while receiving chemotherapy infusion or waiting for a doctor's appointment or tests.
16083063|NCT02286453|Drug|Benjakul recipe|Benjakul recipe capsule at dose of 100 mg three times a day after meal daily for 28 days
16083064|NCT02286453|Drug|diclofenac|diclofenac capsule at dose of 25 mg three times a day after meal daily for 28 days
16083065|NCT02286440|Other|AssureRx GeneSight genotyping results|
16083066|NCT02286440|Other|Treatment as usual|
16083067|NCT02286427|Device|Amniotic Membrane|
16083068|NCT02286414|Drug|Direct oral antocoagulant: dabigatran, rivaroxaban, apixaban|Exposure to direct oral antocoagulants : dabigatran, rivaroxaban, apixaban
16083069|NCT02286414|Drug|Vitamin K antagonist: warfarin, fluindione, acenocoumarol|Exposure to vitamin K antagonist
16083070|NCT02286388|Procedure|A one-step partial caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth.|"Instruments and procedures:
~Soprolife® (Acteon, La Ciotat, France) dental imaging device to detect dentinal infection status. The green-black light indicates infected dentin, red indicates infected/affected dentin and green indicates healthy dentinal tissue.
~Sterile round bur under water spray coolant followed by final excavation with hand instruments The clinician will remove the superficial necrotic and demineralized dentin with complete excavation of the peripheral demineralized dentin, avoiding excavation close to the pulp.
~Hand instruments will be used for final excavation following clinical criteria guidelines (color of residual dentin and probe resistance) and taking in to consideration the color data obtained by the Soprolife® camera.
~The operator will stop excavating when the dentin close to the pulp appears red (for infected dentin)."
16083071|NCT02286388|Procedure|A complete caries removal procedure for the treatment of deep carious lesions in posterior permanent teeth.|"Instruments and procedures:
~Idem partial excavation arm.
~In the complete excavation arm, the operator will stop excavating when the dentin close to the pulp appears green (for healthy dentin tissue) using the Soprolife® camera, leaving no infected or affected dentin."
16083136|NCT02285777|Biological|Placebo|One dose of placebo administered intramuscularly in the deltoid area of a non-dominant arm at Month 6 (Visit 1)
16083137|NCT02285764|Other|Nutritional Supplement|Modified carbohydrate
16083138|NCT02285764|Other|Standard of Care|As determined by the study site
16083139|NCT02285751|Drug|acetylsalicylic acid|
16083140|NCT02285751|Drug|clopidogrel|
16083072|NCT02286388|Device|The application of an antibacterial dental adhesive (ClearfilTM SE Protect, Kuraray Dental).|"Enamel and dentin will be conditioned according to the manufacturer's instructions. Both antibacterial and conventional adhesives are two-steps bonding systems.
~The first step consists of the application of a primer to the enamel and dentin for 20 seconds (which allows the completion of etching and priming procedures). The second step consists of the application of the antibacterial adhesive and its light curing for 10 seconds."
16083073|NCT02286388|Device|The application of a conventional dental adhesive (ClearfilTM SE Bond, Kuraray Dental)|Idem antibacterial dental adhesive arm. A conventional dental adhesive will be used instead of an antibacterial.
16083074|NCT02286375|Behavioral|Intervention group|A structured assessment is conducted using the Omaha system. Problems will be identified in the four domains which include environment, psychosocial, physiological and health-related behavior. According to the identified problems, the nurse case manager and older adults will set contract goals and formulate an individual care plan. The nurse case manager will provide information on the basic knowledge of participants' own chronic illnesses; recognition, measurement and management of the early signs and symptoms of a deterioration or exacerbation of diseases; and the importance of health-promoting and self-care activities. A booklet will be given to them for easy reference and act as a reminder to consolidate the knowledge in case the important concepts are forgotten.
16083075|NCT02286349|Device|Transcranial magnetic stimulation (Neurosoft®)|Repetitive transcranial magnetic stimulation
16083076|NCT02286349|Device|Transcranial direct current stimulation (Soterix, USA)|Transcranial direct current stimulation
16083077|NCT02286336|Other|brachial plexus block|brachial plexus block with ropivacaine 40ml
16083078|NCT02286323|Device|Bonfils|Bonfils Intubation Fiberoscope
16083079|NCT02286323|Device|Macintosh|Direct laryngoscopy using Macintosh Laryngoscope
16083080|NCT02286310|Other|Kinetic Chain Exercises|Exercises include kinetic chain segments.
16083081|NCT02286310|Other|Traditional Exercises|Stretching, strengthening exercises.
16083082|NCT02286297|Device|McGRATH® MAC|video-laryngoscopy-1
16083083|NCT02286297|Device|AirTraq|video-laryngoscopy-2
16083084|NCT02286297|Device|GlideScope|video-laryngoscopy-3
16083085|NCT02286297|Device|Miller|Direct laryngoscopy
16083086|NCT02286284|Device|Apheresis for extracorporal removal of sFlt-1|
16083087|NCT02286258|Drug|Calcium EDTA|"Calcium EDTA for equilibrium GFR measurement : bolus injection 30 mg/kg, then 10 mg/min perfusion for estimated renal clearance 100 mL /min for 4 hours.
~Calcium EDTA for single injection GFR measurement : bolus injection depending on the estimated GFR"
16083088|NCT02286258|Drug|Gd-DOTA|"Gd-DOTA for equilibrium GFR measurement : bolus injection 56 ng/kg, then 28 ng/min perfusion for estimated renal clearance 100 mL /min for 4 hours.
~Gd-DOTA for single injection GFR measurement : bolus injection depending on the estimated GFR"
16083089|NCT02286245|Other|focused Telephonic Medical Advice|The physician will implement a protocol of care to each patient call for an isolated fever and/or symptoms of gastroenteritis: medical advice, drug prescription by phone and supervisory board
16083090|NCT02286245|Other|Usual practice|The physician will decide for the same disease (isolated fever and/or symptoms of gastroenteritis) the need of telephone advice with or without drug prescription, home visit by a doctor, emergency department services with or without EMS system.
16083091|NCT02286232|Behavioral|Stretching exercise|This program begins with 10 stretches/exercises over 15 minutes on the initial class and incrementally increases by 1 stretch/exercise each session for a total of 21 stretches/exercises over 30 minutes on the 12th session. The program is designed to stretch/exercise the major muscle groups, emphasizing the neck and arms, trunk, and legs. In addition to the stretches, each class will include breathing exercises and guided imagery for relaxation. Classes will be taught by Physical Therapists who are trained to lead classes through the protocol.
16083092|NCT02286232|Behavioral|Self-care book|The Back Pain Helpbook which provides information on the causes of back pain and advice on exercising, making appropriate lifestyle modifications, and managing flare-ups.
16083093|NCT02286219|Drug|FS102|Experimental
16083094|NCT02286206|Drug|Clozapine|One-half baseline dose po bid (or one-third baseline dose po qam and two-thirds baseline dose po qhs at the discretion of the treating clinicians and principal investigator)
16083095|NCT02286193|Behavioral|Patient clinical encounters with Community Resource Specialist (CRS)|CRS will work with patients to create goals, develop action plans and link to community resources to support goals
16083096|NCT02286167|Other|Diet modification|All patients will be participate in the intermittent, modified Atkins diet
16083097|NCT02286154|Drug|Hydroxyurea|For New Cohort participants, PK/PD data will be used to predict the most effective maximum tolerated dose. Old Cohort participants will receive hydroxyurea escalated to MTD as per local clinical guidelines.
16083098|NCT02286115|Behavioral|Life-Stress Interview|A life-stress interview which aims to help patients: a) disclose their stressful experiences and emotional conflicts, which might be contributing to their symptoms, b) learn about associations between their stress and physical symptoms; and c) learn about the potential value of experiencing and expressing their emotions related to these stressful situations
16083099|NCT02286102|Device|OrthoPAT|OrthoPAT drain to collect and retransfuse postoperative blood loss. Drains will be removed 48 hours postoperatively
16083100|NCT02286102|Device|Constavac|Constavac drain to collect postoperative blood loss. Drains will be removed 48 hours postoperatively
16083101|NCT02286089|Biological|OpRegen|Targeted dose of 50,000 - 200,000 cells will be delivered into the subretinal space
16083102|NCT02286063|Drug|Ambulatory Oxygen|"The IMP investigated in this study is medical oxygen (PL 15929/005), manufactured by Air Liquide Ltd. UK. Oxygen is a colourless, odourless gas with molecular weight 32, a boiling point of 183.1°C (at 1 bar) and a density of 1.355 kg/m3 (at 15°C and 1013mb).
~Oxygen is present in the atmosphere at 21% and is an absolute necessity for life. Each of the four oxygen companies across the UK provide a light and a standard weight oxygen cylinder. Ambulatory Oxygen will be given to the Oxygen arm."
16083103|NCT02286050|Other|CF Nursing Program|
16083141|NCT02285751|Drug|prasugrel|
16083142|NCT02285751|Drug|ticagrelor|
16083143|NCT02285738|Drug|Aspirin|81mg/day for 4 weeks
16083144|NCT02285738|Drug|Simvastatin|Daily dose of Simvastatin for 4 weeks
16083145|NCT02285738|Other|Observation|participants will be observed for thrombotic evens for 4 weeks
16083104|NCT02286011|Biological|MNC (Mononuclear cells)|"The cells are infused into the TA muscle of the lower limb randomized as Group A (experimental) intramuscularly. The infusion is made with a needle, 26 gauge, at 4 points of the TA muscle a specific depth given by the neurophysiological study. The total volume infused will be 2 ml, 0.5 ml at each point.
~For infusion is as painless as possible for the patient to comply exactly with stereotactic indications of neurophysiology, the infusion was made at a uniform controlled rate and for this, the syringe is placed on a Yesargil arm, equipped with a microinjector and controlled infusion device."
16083105|NCT02286011|Other|Saline|The placebo, 2ml of saline, will be infused like in the experimental arm.
16083106|NCT02285998|Biological|Flublok Quadrivalent Influenza Vaccine|Intramuscular injection of vaccine
16083107|NCT02285998|Biological|Inactivated Influenza Vaccine|Intramuscular injection of vaccine
16083108|NCT02285985|Drug|Saxagliptin|Tablets: 5 mg
16083109|NCT02285985|Drug|Placebo|Tablets: 5mg
16083110|NCT02285972|Drug|saline|before the anesthesia induction, 2mL saline iv injection
16083111|NCT02285972|Drug|dexketoprofen|before the anesthesia induction, 50 mg (2mL) iv dexketoprofen
16083112|NCT02285972|Drug|tenoxicam|before the anesthesia induction, 20 mg (2mL) iv tenoxicam
16083113|NCT02285959|Drug|Bevacizumab|
16083114|NCT02285946|Procedure|major spine surgery|
16083115|NCT02285933|Other|virtual reality training|Each participant will engage in 10-12 sessions of 30-50 minutes each of virtual reality training (VRT) using Jintronix Rehabilitation Software and three-dimensional motion capture technology. A camera captures the movements of the participant and allows him or her to control an avatar, which interacts with the game. Exercises challenge sitting balance control, reaching and shifting the base of support; for example, controlling a ball as it rolls down a maze or reaching to put dishes away in a virtual kitchen. The difficulty of the games is monitored to maintain a challenge to sitting balance. The participant sits on a CONFORMat pressure mat which continuously monitors his or her centre of pressure to ensure that the participant is adequately challenged during the VRT.
16083116|NCT02285933|Other|control|Each participant will engage in 10-12 sessions of 30-50 minutes each of virtual reality training (VRT) using Jintronix Rehabilitation Software and three-dimensional motion capture technology. A camera captures the movements of the participant and allows him or her to control an avatar, which interacts with the game. Control group exercises require limited hand and arm movements; for example, using an arm to move a fish along a simple pathway or using the arms to pop balloons without reaching. Control group participants are strapped into their chair to minimize trunk movement. The participant sits on a CONFORMat pressure mat which continuously monitors his or her centre during the VRT.
16083117|NCT02285920|Drug|Spironolactone|The trial will be conducted in 2 phases - a dose escalation phase (6 weeks) and a treatment phase (30 weeks). At the end of the dose escalation phase, participants will continue treatment based on the randomized dose assignment for an additional 30 weeks (treatment phase) such that the total duration of study medication is 36 weeks.
16083118|NCT02285907|Other|Macronutrient and Fiber Matched BEEF|The participants will consume the macronutrient and fiber matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef (Cargill, KS). Soy fiber (Nutritional Designs, NY) was added to the BEEF meal to match total final content between meals.The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).
16083119|NCT02285907|Other|Macronutrient and Fiber Matched SOY|The participants will consume the macronutrient and fiber matched SOY lunch on a single testing day. SOY contained 33% protein, 43% CHO, and 24% fat; the SOY meal contained 24 g of textured soy protein concentrate (Boca Foods, WI).
16083120|NCT02285907|Other|Serving Size Matched BEEF|The participants will consume the serving size matched BEEF lunch on a single testing day. BEEF contained 33% protein, 43% CHO, and 24% fat; the BEEF meal contained 24 g of beef protein from 96% lean ground beef patty (Cargill, KS).
16083121|NCT02285907|Other|Serving Size Matched SOY|The participants will consume the serving size matched SOY lunch on a single testing day. SOY contained 24% protein, 49% CHO, and 24% fat; the SOY meal contained 14 g of textured soy protein concentrate (Boca Foods, WI).
16083122|NCT02285894|Other|Inspiratory hold|Sustainment of the ventilators inspiratory pressure for 10 seconds at a time
16083123|NCT02285881|Behavioral|Shared decision making|In the intervention practices the SDM process is used. In the SDM proces the patient and GP use a decision aid to discuss the pros and cons of two evidence based treatment possibilities, according to the Dutch College of General Practitioners (NHG) versus the ADDITION guideline, and the patients' preferences for either of these treatments. Together they choose one of these treatments, and set the five treatment targets (blood pressure, cholesterol, HbA1c, smoking status and weight) in order of priority. Subsequent treatment will take place according to the priorities of these OPTIMAL treatment targets. The priorities will be evaluated every 12 months.
16083124|NCT02285855|Drug|Metformin|Metformin treatment given at a dose of 2000 mg by mouth in divided dose daily (500 mg am, 1000 mg noon, 500 mg pm). To reduce GI toxicity, participants start Metformin at 1000 mg daily in a divided dose (500mg am, 500 mg pm) for 1 week.
16083125|NCT02285855|Other|Placebo|Placebo treatment given 3 weeks prior to SBRT treatment and for 1 week during SBRT treatment. Placebo administered by mouth three times a day.
16083126|NCT02285855|Radiation|Stereotactic body Radiotherapy (SBRT)|SBRT delivered per standard of care practice as determined by participant's physician.
16083127|NCT02285842|Device|Primary hip resurfacing device|CONSERVE® Press-Fit Femoral Components
16083128|NCT02285829|Drug|Rocuronium Bromide, Cisatracurium Besylate|Both Rocuronium Bromide and Cisatracurium Besylate are administered intravenously following induction of anesthesia initially by bolus, and subsequently re-bolused or administered in continuous infusion as clinically indicated to maintain muscle relaxation. Initial doses of Rocuronium range from 0.45 to 1.2 mg/kg IV, and doses for continuous infusion range from 0.01-0.012 mg/kg/min IV. Initial doses of Cisatracurium range from 0.15 to 0.2 mg/kg, and doses for continuous infusion range from 0.5 to 3 µg/kg/min. Following recovery and baseline screw stimulation at TOF >0.9, the dosing regimen for this study will rely on restarting a continuous infusion, and adjusting the infusion until the desired TOF ratios are reached. Following screw stimulations and data collection, the infusion will be terminated, and neuromuscular blockade allowed to recover.
16083129|NCT02285816|Biological|MG1MA3|MG1MA3: Boosting component of Oncolytic Vaccine
16083147|NCT02285725|Biological|Injections of BMAC + PRP + HA|All patients will receive up to 12 post-operative intra-articular knee injections of BMAC (derived from iliac crest), PRP (derived from peripheral blood) and HA (Supartz)
16083148|NCT02285712|Device|Vascular ultrasound system|
16083149|NCT02285699|Drug|SSRIs|12-weeks of standard SSRi treatment for those interested in Phase II of the study.
16083150|NCT02285673|Biological|Umbilical Cord Mesenchymal Stem Cell|
16083151|NCT02285660|Procedure|4D PET-CT Scan|
16083152|NCT02285660|Other|No intervention|
16083153|NCT02285647|Drug|Rolapitant - Oral|Oral Treatment A Investigational Product: Rolapitant Dose: 200 mg (4 x 50 mg) Route of Administration: Oral Dosage Form: Capsule Dosing Condition: Fasted (10 hours overnight)
16083154|NCT02285647|Drug|Rolapitant - IV|IV Treatment B Investigational Product: Rolapitant Dose: 185 mg Route of Administration: IV (30 minutes) Dosage Form: 2 mg/mL solution Dosing Condition: Fasted (10 hours overnight)
16083155|NCT02285634|Drug|Oxymetazoline 0.05%|sterile gauze soaked in 5 milliliters (mL) of Oxymetazoline 0.05% into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes.
16083156|NCT02285634|Drug|Phenylephrine 0.25%|sterile gauze soaked in 5 milliliters (mL) of Phenylephrine 0.25% into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes.
16083157|NCT02285634|Drug|Lidocaine 1% plus epinephrine 1:100,000|sterile gauze soaked in 5 milliliters (mL) of Lidocaine 1% plus epinephrine 1:100,000 into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes.
16083158|NCT02285634|Drug|Bacteriostatic 0.9% NaCL|sterile gauze soaked in 5 milliliters (mL) of Bacteriostatic 0.9% NaCL into one nostril and placement of a nasal clamp. The nasal clamp and medication will be removed after 15 minutes.
16083159|NCT02285621|Other|Optimized brace versus conventional Boston brace|Surface topography using Inspeck cameras allows production of a 3D reconstruction of the patient's trunk, this reconstruction will help to produce the optimized brace. Radiographic and patient-reported data will be gathered and analyzed to observe changes between time points. All radiographs will be taken with an EOS imaging system to allow 3D reconstructions. The SRS-22r will be collected at all clinical visits. Study questions will be aligned as much as possible with other prospective scoliosis protocols so as to minimize patient and surgeon response burden. The study protocol requires no additional visits or radiographs beyond standard of care. Ibuttons are installed in each brace and used to measure the compliance of the patient.
16083160|NCT02285608|Other|PIMM/SAM|The PIMM program will include education to improve patients' knowledge regarding their medication's purpose, dosage, benefits, and side effects. The program will also include tools like a checklist or alarm clock to remind patients of when and how to take their medication. Furthermore, the program will contain an interactive listening period where healthcare professionals involved in medication dispensing will listen to patients' concerns, questions and thoughts regarding their medications.
16083161|NCT02285595|Device|Sonendo GentleWave™ System|
16083162|NCT02285582|Other|Registry study|No intervention.
16083163|NCT02285556|Behavioral|psychological rehabilitation training|The main content is self-awareness training, social and moral strengthening, impulse control training , problem solving training , situational awareness training , HIV prevention, social skills training under the family atmosphere , family social skills training , interpersonal skills training, community interaction skills training , psychiatric symptoms of self-monitoring skills training and so on.
16083164|NCT02285556|Behavioral|physical and neurological rehabilitation training|The main content is drug rehabilitation exercise and functional physical training. Rehabilitation led by the discipline cadres , practice once a day, each lasting about 15 minutes .
16083165|NCT02285556|Radiation|rTMS 10HZ high frequency stimulation|Stimulate the dorsolateral prefrontal and parietal lower part , 4 weeks of therapeutic intervention (5 times / week).
16083166|NCT02285556|Radiation|fake rTMS 10HZ high frequency stimulation|Fake stimulate the dorsolateral prefrontal and parietal lower part , 4 weeks of therapeutic intervention (5 times / week).
16083167|NCT02285543|Drug|TPF induction chemotherapy|"TPF induction chemotherapy: 2 cycles; docetaxel(75mg/m^2), cisplatin(75 mg/m^2), 5-Fu(750 mg/m^2/day) for 5 days; 16 days later, the 2nd cycle. 2 weeks later, surgery.
~Surgery: radical resection and full neck dissection with reconstruction. Radiotherapy: 4-6 weeks after surgery, 1.8-2Gy/day, 5 days/week for 6 weeks, and totally 54-60Gy"
16083168|NCT02285543|Procedure|surgery|In the TPF group,surgery was performed at least 2 weeks after completion of induction chemotherapy.Surgery group includes radical resection of the primary lesion and full neck dissection(functional or radical) with proper reconstruction(pedicle or free flap) were performed.
16083169|NCT02285543|Radiation|radiotherapy|Radiotherapy was arranged 4 to 6 weeks after surgery.Routine external beam radiotherapy, such as conformal or intensity modulated radiotherapy was performed, and the dose was 1.8-2 Gy(gray)/day, 5 days/week for 6 weeks, and totally 54-60 Gy.
16083170|NCT02285530|Drug|TPF induction chemotherapy|TPF induction chemotherapy: 2 cycles; docetaxel(75mg/m^2), cisplatin(75 mg/m^2), 5-Fu(750 mg/m^2/day) for 5 days; 16 days later, the 2nd cycle.
16083171|NCT02285530|Procedure|surgery group|Radical resection of the primary lesion and full neck dissection(functional or radical) with proper reconstruction(pedicle or free flap) were performed.
16083172|NCT02285530|Radiation|Post-operative radiotherapy|Radiotherapy was arranged 4 to 6 weeks after surgery. Routine external beam radiotherapy, such as conformal or intensity modulated radiotherapy was performed and the dose was 1.8-2 Gy/day, 5 days/week for 6 weeks, and totally 54-60 Gy.
16083173|NCT02285517|Procedure|modified Meek skin grafting technique|patients with third degree of burns and without infected wounds are entered to the study and modified Meek skin grating technique is used to treat them and then the results of the procedure are compared to mesh skin grafting technique results by measuring the square centimeters of healed areas related to the technique
16083174|NCT02285517|Procedure|mesh skin grafting technique|patients with third degree of burns and without infected wounds are entered to the study and mesh skin grating technique is used to treat them and then the results of the procedure are compared to modified Meek skin grafting technique results by measuring the square centimeters of healed areas related to the technique
16083175|NCT02285504|Drug|SAGE-547|Intravenous
16083176|NCT02285491|Drug|10ml of bupivacaine 0.5%|This is a local anesthetic that will be used to block the ilioinguinal nerve to alleviate pain at the wound site after lscs
16083177|NCT02285491|Drug|Placebo|10 ml of saline will be injected as a placebo and the investigator and the patient and the data assessor are all blinded to what the patients received.
16083178|NCT02285465|Drug|ASP3700|Oral
16083179|NCT02285465|Drug|Placebo|Oral
16083180|NCT02285452|Drug|Zingiberis Rhizoma plv.|
16083181|NCT02285452|Drug|Sinapis nigrea semen|
16083182|NCT02285452|Drug|Placebo|
16083183|NCT02285439|Drug|MEK162|• MEK162 is currently supplied as film-coated tablets in dose strength of 15 mg. The film-coated tablets consist of MEK162 drug substance, lactose monohydrate, microcrystalline cellulose, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and a commercial film coating. The original tablets are yellow to dark yellow capsule-shaped
16083184|NCT02285426|Device|Pentax EB-1990i HD-bronchoscope guided biopsy|"3 different types of bronchoscopy image settings will be used investigating the entire bronchial tree.
~When sites with abnormal or suspicious vascular patterns are detected meeting the criteria of abnormality [visual scale adapted from Herth 2009 and Zaric 2013] the investigator will change to a normal bronchoscope and take biopsies from each site and a biopsy from a normal secondary carina on the contralateral site as control."
16083185|NCT02285413|Biological|DC vaccination|DC vaccination without cisplatinum
16083186|NCT02285413|Biological|DC vaccination with cisplatinum|DC vaccination with cisplatinum
16083187|NCT02285400|Procedure|CPAP level|CPAP level ranges between 4 and 12 cm water column (cmH2O), each pressure increment for 1 cmH2O.
16083188|NCT02285387|Procedure|Rhythm control|"Start AAD right after evaluating for LA size, EF, LA thrombus, and presence of CAD during anticoagulation
~Cardioversion after 1 month
~Rhythm FU schedule (2012 ACC/AHA/ESC guidelines)
~If AF recur, RFCA"
16083189|NCT02285387|Procedure|Rate control|"No AAD, just anticoagulation
~HR control between 60~110bpm (with beta blocker, calcium channel blocker, digoxin)
~Without the treatment about antiarrhythmia and rhythm control, deification of rate control, the subject will be drop out for study."
16083190|NCT02285374|Drug|Dolutegravir, efavirenz, efavirenz/emtricitabine/tenofovir|Arm 1: Switch efavirenz to dolutegravir immediately (at baseline) for 12 weeks Arm 2: Continue on pre-study regimen (unchanged) for 4 weeks and then switch efavirenz to dolutegravir for 12 weeks
16083191|NCT02285361|Drug|GIOTRIF 20mg|NSCLC with GIOTRIF 20mg
16083192|NCT02285361|Drug|GIOTRIF 40mg|NSCLC with GIOTRIF 40mg
16083193|NCT02285361|Drug|GIOTRIF 30mg|NSCLC with GIOTRIF 30mg
16083194|NCT02285348|Procedure|Lumbar puncture|Lumbar puncture is done according to general practice
16083195|NCT02285335|Dietary Supplement|GINST|The study is designed with using GINST either 500mg/capsule or 1000mg/capsule, two capsules at once, three times a day for 12 weeks.
16083196|NCT02285309|Procedure|Cardiac Surgery and enoximone|Does diastolic function change with cardiac surgery +/- enoximone
16083197|NCT02285296|Other|personalized support program|"interview of the primary caregivers to identify their needs and expectations, the implementation of a personalized support program, including telephone follow-up"
16083198|NCT02285283|Drug|Itraconazole|
16083199|NCT02285283|Drug|Placebo|
16083200|NCT02285270|Device|FDG PET/CT|PET/CT is a hybrid imaging modality that allows imaging positron emitting isotopes such as F-18 along with anatomic imaging using x-rays. The physiologic information from the PET component is co-registered with the anatomic information from the CT component, permitting accurate localization and quantification of physiologic processes. The most common clinically used positron emitting radiopharmaceutical is F-18 fluorodeoxyglucose (FDG). It is a glucose analog which is taken up by glucose transporters and phosphorylated to FDG-6P by hexokinase. FDG PET/CT gives a map of relative amount of glucose uptake and phosphorylation over the interval from injection to scan.
16083201|NCT02285244|Drug|sotrastaurin acetate|Given PO
16083202|NCT02285244|Other|pharmacological study|Correlative studies
16083203|NCT02285244|Other|laboratory biomarker analysis|Correlative studies
16083204|NCT02285231|Dietary Supplement|Arginyl-fructose|
16083205|NCT02285231|Dietary Supplement|Placebo|
16083206|NCT02285218|Other|serum blood sampling|
16083207|NCT02285205|Drug|Oral administration of Lobeglitazone|Lobeglitazone 0.5mg/tablet, orally, 1 tablet once daily for 24 weeks
16083208|NCT02285192|Radiation|18F-Fluorodeoxyglucose (18F-FDG)|
16083209|NCT02285192|Device|PET/CT imaging|
16083210|NCT02285192|Device|PET/MRI imaging|
16083213|NCT02285166|Drug|Omega-3-acid ethyl esters|Omega-3 fatty acid ethyl esters granular capsules
16083214|NCT02285166|Drug|Standard antihyperlipidemic therapy other than administration of omega-3 fatty acid ethyl esters (Lotriga).|
16083215|NCT02285153|Drug|Acetylsalicylic acid lysinate|100mg intravenously administered Acetylsalicylic Acid lysinate per day
16083216|NCT02285153|Drug|0.9% sodium-chloride solution|Placebo, intravenously administered, daily
16083217|NCT02285140|Drug|Cefazolin|administration as outlined
16083218|NCT02285140|Drug|Vancomycin|administration as outlined
16083219|NCT02285127|Procedure|Short versus long cephalomedullary Intramedullary nail|Biomet Affixus Short and Long hip fracture nail. Stryker Gamma Short and Long hip fracture nail.
16083220|NCT02285114|Drug|F/TAF|F/TAF tablets administered orally once daily
16083221|NCT02285114|Drug|3rd ARV agent|A 3rd antiretroviral (ARV) agent of the participant's pre-existing regimen may include one of the following: boosted atazanavir (ATV), boosted lopinavir (LPV), boosted darunavir (DRV), unboosted efavirenz (EFV), unboosted nevirapine (NVP), unboosted raltegravir (RAL), or unboosted dolutegravir (DTG).
16083222|NCT02285114|Drug|Boosted PIs|Boosted PIs of the participant's pre-existing regimen may include one of the following: ATV, LPV, or DRV.
16083223|NCT02285101|Biological|PEG-BCT-100|
16083224|NCT02285088|Drug|GBT440|GBT440 will be administered as oral capsules
16083225|NCT02285088|Drug|Placebo|Matching placebo will be administered as oral capsules
16083266|NCT02284802|Procedure|Confocal endomicroscopy|Confocal endomicroscopy examination during endoscopy
16085457|NCT02268773|Drug|Acetylsalicylic acid low dose|
16083226|NCT02285075|Drug|temocillin PK/PD in haemodialysis|Pharmacokinetic study measuring total and free temocillin concentrations just before, and at 0.5, 3, 6, 12, 20 (before dialysis) and 24 (at the end of dialysis) hours after start of the infusion when patients were dialysed with a 1-day interval; just before and at 0.5, 3, 6, 12, 24, 36, 44 (before dialysis) and 48 (at the end of dialysis) hours after start of the infusion when patients were dialysed with a 2-day interval, and just before and at 0.5, 3, 6, 12, 24, 36, 48, 68 (before dialysis) and 72 (at the end of dialysis) hours after start of the infusion if patients were dialysed with a 3-day interval in order to determine basic PK and PD parameters in patients treated with intermittent haemodialysis and temocillin (Vd, T1/2, protein binding, clearance, reduction rate and T > MIC of 8 and 16 mg/L).
16083227|NCT02285062|Drug|lenalidomide|
16083228|NCT02285062|Drug|Placebo|
16083229|NCT02285062|Drug|Rituximab|
16083230|NCT02285062|Drug|Cyclophosphamide|
16083231|NCT02285062|Drug|Doxorubicin|
16083232|NCT02285062|Drug|prednisone|
16083233|NCT02285062|Drug|vincristine|
16083234|NCT02285049|Other|Urticaria Control Test|"The patients get the 1st UAS28 form and four-week appointment to follow up.
~Collect completed UAS28 assessment, Patient's global assessment of disease severity (PatGA-LS) and Physician's global assessment of disease control (PhyGA-LS)
~Then patients fill the 1st UCT and DLQI questionnaire by themselves.
~The patients get the 2nd UAS28 form and four-week appointment to follow up.
~At the 2nd visit, collect completed UAS28 assessment. Assessment the severity of chronic urticaria symptoms by Patient's global assessment of disease severity (PatGA-LS) and Physician's global assessment of disease control (PhyGA-LS). The patients fill the UCT and DLQI and questionnaire by themselves."
16083235|NCT02285036|Biological|vaccination PPV23|All eligible participants were stratified into four age strata namely, 2 to 6 years, 7 to 17 years, 18 to 59 years and more than 60 years. Stratified, block randomization with a size of eight was applied. Vaccination of single dose of either treatment vaccine or control vaccine intramuscularly was performed in a ratio of 1:1. Blood samples were obtained from each subject at baseline, day 30-35 after injection, to evaluate immunogenicity.
16083236|NCT02285036|Biological|vaccination PNEUMOVAX 23|Vaccination of single dose of either treatment vaccine or control vaccine intramuscularly was performed in a ratio of 1:1.
16083237|NCT02285023|Other|CU-Q2oL|"The patients will be explained how to complete the Urticaria Activity Score (UAS7) form for evaluating their severity of chronic urticaria symptoms at home.
~At the 2nd visit, collect the 1st UAS7 assessment. Assessment the severity of chronic urticaria symptoms. The patients fill the 1st DLQI and CU-Q2oL questionnaire and get the 2nd UAS7 form and two-week appointment to follow up.
~At the 3th visit, collect the 2nd UAS7 assessment. Assessment the severity of chronic urticaria symptoms. The patients fill the 2nd DLQI and CU-Q2oL questionnaire."
16083238|NCT02285010|Drug|placebo|Placebo in capsule is prescribed to the patient 60 min prior to the surgery. Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed.
16083239|NCT02285010|Drug|Pregabalin|"Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.
~Ringer Lactate Solution preload 15 mL/kg prior to surgery. Spinal anesthesia is done with 0.5% Heavy bupivacaine + morphine 0.2 mg total volume 3.0 - 3.6 mL. IV PCA Morphine is applied at PACU (bolus dose only 1 mg, lockout interval 5 min, 4 hr limit 35 mg). As soon as the patient is allowed to sip, paracetamol (500 mg) 1 tab PO every 6 hours is prescribed."
16083240|NCT02284997|Device|MGDRx® EyeBag|Class 1 Medical Device, registered with the Medicines and Healthcare products Regulatory Agency. UK Patent: GB2421687B. The EyeBag is made of silk and 100% brushed black cotton and filled with flax / linseed. When heated, this device is intended to warm the eyelids. This melts the meibum and clears the meibum obstruction of the MGs.
16083241|NCT02284984|Drug|Rituximab with belimumab|Rituximab treatment on dag 0 and 14, 1000mg iv Belimumab 10mg/kg on day 28, day 42 and day 56. Thereafter, patients will receive Belimumab 10mg/kg every 4 weeks through 72 weeks.
16083242|NCT02284971|Biological|CDX1127|
16083243|NCT02284971|Radiation|SBRT|
16083244|NCT02284958|Behavioral|Standard|Back care advice
16083245|NCT02284958|Behavioral|Walking|Back care advice, individualized 12 week pedometer-driven walking program
16083246|NCT02284945|Procedure|Open fixation|
16083247|NCT02284945|Procedure|Keyhole surgery|
16083248|NCT02284932|Other|No specific intervention for this study|No specific intervention for this study
16083249|NCT02284919|Drug|[18F]ISO-1|[18F]ISO-1 PET/CT scan
16083250|NCT02284906|Drug|Pioglitazone|Pioglitazone tablets
16083251|NCT02284906|Drug|Placebo|Pioglitazone placebo-matching tablets
16083252|NCT02284893|Drug|Saxagliptin|administered orally once daily
16083253|NCT02284893|Drug|Dapagliflozin|administered orally once daily
16083254|NCT02284893|Drug|Sitagliptin|administered orally once daily
16083255|NCT02284893|Drug|Placebo matching with Saxagliptin|administered orally once daily
16083256|NCT02284893|Drug|Placebo matching with Dapagliflozin|administered orally once daily
16083257|NCT02284893|Drug|Placebo matching with Sitagliptin|administered orally once daily
16083258|NCT02284880|Drug|BIA 2-093|MF - Marketed formulation
16083259|NCT02284880|Drug|BIA 2-093|TBM - to-be-marketed
16083260|NCT02284867|Other|immunohistochemistry study|After taking informed written consent,a placental sample will be taken either the patient delivered preterm or at term (term patients will be either control term group or patients with successful treatment of preterm labor). The placental sample taken should have part of the decidua and then the sample will be fixed in 10% neutral-buffered formalin for 24-48 h, routinely processed, embedded in paraffin wax, sectioned at 3 μm thickness, and mounted on 3-aminopropyl-triethoxysilane -coated slides. Serial sections will be immunostained for CD 16 and CD56 . immunohistochemistry study will be done at Ain Shams Maternity Hospital Histopathology department.
16083261|NCT02284854|Drug|BIA 2-093|
16083262|NCT02284854|Drug|Carbamazepine|
16083263|NCT02284841|Device|Hilotherm cooling face mask|Hilotherapy - use of an external cooling device; a facial mask through which water circulates at a controlled temperature, allowing continuous cooling of the face, and is thought to reduce post-operative swelling and pain.
16083264|NCT02284828|Drug|BIA 2-093|
16083267|NCT02284789|Other|Colorado Adult Joint Assessment Evaluation|Physical evaluation of 6 joints, ankles, knees and elbows
16083268|NCT02284776|Behavioral|Therapeutic education|People in hydrotherapeutic cure are following a program of Therapeutic Education. This program includes dietary advice, physical activities, behavior advice in order to change the lifestyle of the obese people.
16083269|NCT02284763|Other|EtCO2|Initial data collection during BCP was performed following three conditions were satisfied: after start of surgery; at least 15 min after BCP (for stabilization of MAP); after ventilation frequency was adjusted to produce EtCO2 of 27-29 mmHg with tidal volume of 8 ml/kg. Data was collected every 3 min after decreasing ventilation frequency by 1-2 breaths/min to increase EtCO2 until 42-45 mmHg. Once the value of EtCO2 42-45 mmHg was reached, ventilator frequency was increased in the same way to decrease EtCO2 until 27-29 mmHg. Fraction of inspired oxygen of 50% was maintained and end-tidal desflurane concentration was adjusted to achieve bispectral index values of 40-55 during data collection.
16083270|NCT02284750|Procedure|Percutaneous coronary intervention|
16083271|NCT02284737|Procedure|PADN|Contrast pulmonary artery angiography is performed to localize the pulmonary artery bifurcation level and to calculate the PA diameter. Once the anatomy is deemed acceptable, the radiofrequency ablation catheter is introduced into the distal bifurcation area of the main PA. The catheter is then maneuvered within the PA to allow energy delivery to ensure that the electrodes are tightly in contact with the endovascular surface. Two to three ablations at 1-15 W for 120 seconds at each point were performed in the distal bifurcation area of the main PA.
16083272|NCT02284737|Procedure|sham PADN|The radiofrequency ablation catheter placed, no ablations for patients in the sham PADN group.
16083273|NCT02284737|Drug|Sildenafil|Participants initially received 5 mg tadalafil for the first 2 weeks in the two groups. The tadalafil dose may have been up titrated to 40 mg after 2 weeks, with maximum effects being obtained. The up titrated of tadalafil to 40 mg was not mandatory if the investigator decided for tolerability reasons the participants should remain on 5 mg.
16083274|NCT02284724|Procedure|Dry Needling|
16083275|NCT02284724|Procedure|Sham Needling|
16083276|NCT02284711|Device|Bipolar electric energy|Coagulation during salpingectomy using conventional bipolar electric energy
16083277|NCT02284711|Device|ultrasound energy|Coagulation during salpingectomy using UltraCision HARMONIC ACE® ultrasound energy
16083278|NCT02284698|Other|Health Education|Heath education will be given through awareness creation & pamphlet distribution
16083279|NCT02284685|Behavioral|Promoting Eating Disorder Treatment among College Students|Online intervention designed to identify and increase help-seeking among undergraduates with previously undiagnosed/untreated eating disorders
16083280|NCT02284672|Drug|Dexmedetomidine|
16083281|NCT02284672|Drug|Normal saline|
16083282|NCT02284659|Device|Functional Electrical Stimulation (FES)|FES (50Hz / 500us)
16083283|NCT02284659|Device|FES- Sham|
16083284|NCT02284646|Other|Personalized physical training program|9-week personalized physical training program (ergometric bicycle)
16083285|NCT02284620|Procedure|CFNB group|CFNB :A single injection of ropivacaine 30ml for femoral nerve block pre-operatively +0.15% ropivacaine 300ml for continuous femoral nerve block post-operatively guided by ultrasound and nerve stimulator.
16083286|NCT02284620|Procedure|LWI group|LWI: 48 ml of 0.8% ropivacaine with 2 ml of 40mg methylprednisolone for intra-articular and peri-articular wound infiltration intra-operatively in combination with intravenous patient controlled analgesia post-operatively.
16083287|NCT02284607|Drug|MHAA4549A|MHAA4549A single, intravenous dose administration, lower dose level
16083288|NCT02284607|Drug|MHAA4549A|MHAA4549A single, intravenous dose administration, higher dose level
16083289|NCT02284607|Drug|Placebo|Matching placebo to MHAA4549A administration
16083290|NCT02284594|Behavioral|text message|series of text messages regarding influenza vaccination
16083291|NCT02284568|Drug|Placebo|Placebo
16083292|NCT02284568|Drug|Laquinimod|Laquinimod capsules in 0.5 mg and 0.6 mg strengths
16083293|NCT02284568|Drug|Placebo|Placebo capsules
16083294|NCT02284555|Drug|Mupirocin|Mupirocin (Bactroban 2% Nasal Ointment) will be administered twice daily for five days in accordance with the SmPC.
16083297|NCT02284529|Drug|Orectalip|Oxaliplatin 85mg/m2 in D5W 250 ml IV drip 2hrs on D1, Leucovorin 100mg/m2 in N/S 100ml IV drip 2hrs on D1, follow by 5-FU 2400mg/m2 IV infusion 24hrs on D1
16083298|NCT02284516|Drug|Lifitegrast|Lifitegrast Ophthalmic Solution 5%, BID for 84 days
16083299|NCT02284516|Drug|Placebo|Placebo to match active treatment, BID for 84 days
16083300|NCT02284503|Drug|Rosuvastatin|The subjects will receive intensive Rosuvastatin before and after PCI
16083301|NCT02284490|Drug|pemetrexed|Administered intravenously at a dose of 900 mg/m2 every 21 days until disease progression.
16083302|NCT02284477|Other|non- PVC containing packing materials|Beverage which was stored in glass bottle for 24 hours in 4 ℃.
16083303|NCT02284477|Other|PVC containing packing materials|Beverage which was stored in PVC blood bag for 24 hours in 4 ℃.
16083304|NCT02284464|Drug|Prednisone withdrawal|Withdrawal of steroids
16083305|NCT02284464|Drug|Prednisone continuation|Continuation of steroids
16083306|NCT02284451|Other|Video or Pictorial Brochure|Participants will receive HIV/AIDS and HIV testing information by video or by pictorial brochure according to patient health literacy level (lower or higher) and language (English or Spanish).
16083307|NCT02284438|Device|Endotracheal tube|Three endotracheal tubes with different surfaces will be used
16083308|NCT02284425|Drug|REGN1193|
16083309|NCT02284425|Drug|Placebo|
16083310|NCT02284412|Drug|Neostigmine|At a train-of-four (TOF) ratio of 0.5: administration of neostigmine 0.06 mg/kg for reversal of neuromuscular blockade.
16083311|NCT02284412|Drug|Sugammadex|At a train-of-four (TOF) ratio of 0.5: administration of sugammadex 15 mg/kg for reversal of neuromuscular blockade.
16083312|NCT02284412|Drug|Water for injection|At a train-of-four (TOF) ratio of 0.5: administration of placebo for spontaneous recovery of neuromuscular blockade.
16083313|NCT02284399|Other|non-invasive prenatal testing|Noninvasive Prenatal Testing (NIPT) of fetal cell free DNA in maternal circulation
16083314|NCT02284386|Drug|Bupivacaine SNB|SNB with a single 1.6 mL dose of bupivacaine HCl 7.5 mg/mL within 2 hours prior to the surgical procedure.
16083315|NCT02284386|Drug|EXPAREL Infiltration|Local infiltration of EXPAREL 266 mg into the surgical site at the end of the surgery just prior to wound closure.
16083316|NCT02284373|Other|Flexitouch for 1 month in addition to routine wound care|simultaneous wound care and pneumonic compression
16083317|NCT02284373|Other|Routine wound care for venous ulcers and lymphedema|wound care /dressings
16083318|NCT02284373|Device|Flexitouch pneumonic compression|pneumonic compression only
16083319|NCT02284360|Drug|APOSEC™ for cutaneous use|"On day 0, a blinded and randomized test treatment with Verum and Placebo is performed on intact skin. If the subject does not reveal any adverse events, the actual treatment phase is initiated 24h later.
~Following baseline evaluation on day 1, two punch biopsies (4mm) on the inner upper side of the non-dominant arm are set under local anesthesia. One wound on the upper arm (proximal or distal) will be treated with placebo and the second wound will be treated with the allocated concentration of Verum according to previous randomization scheme set for test treatment. Approximately 1ml of Verum vs. placebo will be applied on the artificial wounds.
~From day 2 to 6, artificial wounds will be cleaned with 0.9 % NaCl and then allocated treatment will be administered. Wound dressing will be done daily and will cover the whole area of application.
~On day 7 the treatment is terminated and the wound is evaluated with respect the extension of wound closure."
16083320|NCT02284347|Device|Electromagnetic Sinus Dilation System (NuVent™)|NuVent navigation-guided balloon system may be used to locate and move tissue, bone or cartilaginous tissue obstructing the drainage pathways of the frontal, maxillary, and sphenoid sinuses that is scarred, granulated or previously surgically-altered to facilitate dilation of the sinus ostia.
16083321|NCT02284334|Other|test meal|low- or high-glycemic index test meal, administered during mixed meal tolerance test
16083322|NCT02284308|Other|Blood withdrawal|An extra withdrawal of blood, during a routine blood withdrawal. This is an optional inverventions for patients.
16083323|NCT02284295|Other|exposure to respirable silica dust|History of exposure to respirable silica dust due to job
16083324|NCT02284295|Other|exposure to aromatic hydrocarbons|history of exposure to aromatic hydrocarbons due to job
16083325|NCT02284282|Drug|Spinal injection bupivacaine/morphine|Spinal injection bupivacaine/morphine in laparoscopic surgery
16083326|NCT02284282|Drug|subcutaneum injection lidocaine|placebo injection
16083327|NCT02284269|Drug|SGLT2 Inhibitors|Ipragliflozin (Suglat®), Dapaglilozin (Forxiga®), Tofogliflozin (Deberza® / Apleway®), Luseogliflozin (Lusefi®), Canagliflozin (Canaglu®), Empagliflozin (Jardiance®)
16083328|NCT02284256|Drug|Fibrocaps|
16083329|NCT02284256|Drug|TachoSil|
16083330|NCT02284243|Drug|Intranasal Dexmedetomidine|
16083331|NCT02284243|Drug|Intranasal Placebo|
16083332|NCT02284230|Drug|Liraglutide|
16083333|NCT02284230|Drug|Placebo|
16083334|NCT02284217|Device|EVD|ICP monitoring will be done in parallel for both HS-1000 and ICP monitoring via an EVD device (per clinical protocol without any change in the patient's management). HS-1000 ICP monitoring intervals will last from 30 minutes to 6 hours, continuously depending on the patient's clinical condition. Each such interval may occur three times a day or more depending on the clinical condition of the patient.
16083335|NCT02284204|Drug|Midazolam, Ketamine and Sevoflurane|The combination of these three drugs were administered for the children of the intervention group in a attempt to improve the behavioral control. Midazolam and ketamine orally, sevoflurane inhaled.
16083336|NCT02284204|Drug|Midazolam and Ketamine|The combination of these two drugs were administered orally for the children of the control group.
16083337|NCT02284191|Radiation|CT Coronary Angiogram|Completion of a CT Coronary Angiogram
16083338|NCT02284178|Other|Enhanced oropharyngeal suction|Deep oropharyngeal suction with catheter every 4 hours
16083339|NCT02284178|Other|Usual Care|Oral suction with suction swab every 4 hours
16083340|NCT02284165|Other|retrospective analysis|Analysis of data for patients hospitalized in 2006-2008 with acute ischemic stroke, and successfully linked with Medicare claims through 2009
16083341|NCT02284152|Behavioral|infant-led feeding|mothers' feeding practices and infant intakes were compared between a typical feeding condition and an infant-led feeding condition, where the experimenter ensured the feeding was in response to infant hunger and fullness cues.
16083342|NCT02284139|Drug|Arm EGF ointment 1ppm|EGF Ointment 1ppm evenly apply to skin lesion every 12 hr/ day
16083343|NCT02284139|Drug|Arm EGF ointment 20 ppm|EGF Ointment 20 evenly apply to skin lesion every 12 hr/ day
16083344|NCT02284139|Drug|Arm Placebos|EGF Ointment 0ppm evenly apply to skin lesion every 12 hr/ day
16083345|NCT02284126|Drug|Vancomycin|Topically applied powder and paste to surgical site at time of closure.
16083346|NCT02284113|Device|iovera°|Use of iovera° device to administer treatment Focused Cold Therapy
16083347|NCT02284113|Device|iovera° Sham|iovera° device used for sham treatment
16083348|NCT02284100|Behavioral|animal assisted therapy|"For the AAT session, a 7 year old Golden Retriever was employed as the therapy animal. Prior to the study, the dog underwent rigorous screening although she had previous experience in Animal Assisted Interventions and was already trained and prepared prior for this type of work. The dog was fully vaccinated, bathed regularly, screened for enteric pathogens, and treated for internal and external parasites on a monthly basis. The dog and handler met hospital policy for participating in animal-assisted therapy, including documentation of the dog's current vaccinations, controllability and temperament.
~The welfare of the dog was monitored and certificated by a dedicated veterinary during and at the end of the all sessions."
16083349|NCT02284087|Device|PAS|
16083573|NCT02282514|Drug|Methylprednisolone|Steroid
16083693|NCT02281565|Behavioral|survey|Survey about Knowledge, Attitude and Practice About Blood Donation
16083350|NCT02284074|Other|Nasal LPS spray|LPS solution (250µl) will be prepared at 10, 100, 300 and 1000µg/ml, 100µl is administered to each nostril, both nostrils will be sprayed. The dose per nostril corresponds to 1, 10, 30 and 100µg.
16083351|NCT02284061|Other|physical activities adapted to children|
16083352|NCT02284048|Drug|ticagrelor|compare the effect of ticagrelor and control on the Coronary Flow Reserve in patients with microvessel angian
16083353|NCT02284035|Drug|Raltegravir/3TC|MK0518B (Raltegravir/3TC) (300mg/150mg) twice daily, administered orally in the 300/150 mg film-coated tablets according to instructions in the prescribing information.
16083354|NCT02284035|Drug|EFV/TDF/FTC|standard combination therapy
16083355|NCT02284035|Drug|ATV/r + TDF/FTC or DRV/r + TDF/FTC|
16083356|NCT02284035|Drug|DTG+ABC/3TC DTG+TDF/FTC EVG/cobi/TDF/FTC RAL+TDF/FTC|
16083357|NCT02284035|Drug|EFV plus ABC/3TC or RPV/TDF/FTC|
16083358|NCT02284035|Drug|ATV/r plus ABC/3TC|
16083359|NCT02284035|Drug|DRV/r + ABC/3TC or LPV/r + ABC/3TC or LPV/r + TDF/FTC|
16083360|NCT02284035|Drug|RAL plus ABC/3TC|
16083361|NCT02284035|Drug|Other ART regimens|
16083362|NCT02284022|Device|Brain computer interface|Recording the P300 Testing the device Using the device with a speller
16083363|NCT02284009|Biological|Albiglutide weekly injection|Albiglutide will be provided as a fixed-dose, fully disposable pen injector system having a prefilled dual chamber glass cartridge. To be self-administered as a subcutaneous (SC) injection in the abdomen, thigh or upper arm region. The pen will deliver either 30 mg of albiglutide, 50 mg of albiglutide in a 0.5-mL injection volume. It may be administered at any time of day without regard to meals. It will be administered once a week on the same day each week
16083364|NCT02284009|Biological|Placebo weekly injection|Placebo provided as a fixed-dose, fully disposable pen injector system having a prefilled dual chamber glass cartridge. To be self-administered as a SC injection in the abdomen, thigh or upper arm region. It may be administered at any time of day, once a week on the same day each week, without regard to meals.
16083365|NCT02284009|Biological|Insulin|Commercially available basal/bolus insulin regimen, self administered by the subject, in accordance to the prescription of the physician and as per the package insert
16083368|NCT02283983|Other|mittens and booties|
16083369|NCT02283983|Other|cooling helmet|
16083370|NCT02283957|Drug|CNTX-4975|
16083371|NCT02283957|Other|Placebo|
16083372|NCT02283944|Device|TMS|Pulsed non-invasive brain stimulation using electromagnets
16083373|NCT02283931|Device|TTE / NICOM|
16083374|NCT02283905|Drug|amphotericin-B|continuously infused
16083375|NCT02283905|Drug|voriconazole|intravenously or orally administered
16083376|NCT02283892|Other|Checklist|3 page checklist with suggestions of possible diagnosis according to clinical presentation of patients presenting with dyspnea or cough; also suggests diagnostic tests that are likely to be useful in each situation.
16083377|NCT02283892|Other|Conventional evaluation|Physician evaluation without the use of checklists
16083378|NCT02283879|Biological|Human umbilical cord mesenchymal stem cells|A single dose of 2×107 hUC-MSC will treated to patients, IV, Repeat every weeks for four times.
16083379|NCT02283866|Drug|Administering desflurane according to the patient's BIS value|Administering desflurane according to the patient's BIS value
16083380|NCT02283866|Drug|Administering desflurane at 1 MAC|Administering desflurane at 1 MAC
16083381|NCT02283853|Drug|dimethyl fumarate|administered orally
16083382|NCT02283853|Drug|Interferon β-1a|administered by intramuscular injection
16083383|NCT02283840|Drug|BIA 2-093|
16083384|NCT02283827|Drug|BIA 2-093|
16083385|NCT02283827|Drug|Phenytoin|
16083386|NCT02283814|Drug|BIA 2-093|
16083387|NCT02283814|Drug|Topamax|
16083388|NCT02283801|Drug|Eslicarbazepine acetate|
16083389|NCT02283801|Drug|Lamotrigine|
16083390|NCT02283788|Drug|BIA 2-093|
16083391|NCT02283788|Drug|Moxifloxacin|
16083392|NCT02283788|Drug|Placebo|
16083393|NCT02283775|Drug|Isatuximab SAR650984|Pharmaceutical form:solution for infusion Route of administration: intravenous
16083394|NCT02283775|Drug|Pomalidomide|Pharmaceutical form:capsules Route of administration: oral
16083395|NCT02283775|Drug|Dexamethasone|Pharmaceutical form:tablets or solution for infusion Route of administration: oral or intravenous
16083396|NCT02283762|Drug|Riociguat (Adempas, BAY63-2521)|Starting dose 0.5 mg TID, increase by 0.5 mg every 2 weeks until highest possible dose of 2.5 mg TID
16083397|NCT02283762|Drug|Placebo|Sham-titration
16083398|NCT02283749|Biological|Xofigo|This is a radio-isotope
16083399|NCT02283736|Other|Lactobacillus rhamnosus SP1|Tablet containing Lactobacillus rhamnosus SP1
16083400|NCT02283736|Other|Talc powder|Tablet containing talc powder
16083401|NCT02283736|Procedure|Periodontal treatment|Scaling and root planning
16083402|NCT02283723|Other|Health TAPESTRY Intervention|The patient will receive in-home visits from trained volunteers to assess overall health and wellness and discover any health goals patient might have. This information will be electronically communicated back to interprofessional healthcare team and used to create informed care plan, link to relevant community services and allow the patient to age optimally.
16083403|NCT02283723|Other|Usual care|While waiting for the Health TAPESTRY intervention, the control group will receive usual care from their healthcare providers.
16083404|NCT02283710|Drug|Pentoxifylline|Pentoxifylline 600 mg BD
16083405|NCT02283710|Behavioral|Lifestyle modification|obtaining ideal body weight by calorie restriction diet and programmed physical activity.
16083694|NCT02281552|Drug|Tofacitinib|tofacitinib modified release 11 mg tablet administered once time a day for 12 weeks
16083406|NCT02283697|Behavioral|Dietary Counseling|a standard endorsement of low salt diet and other non-pharmacological interventions such as moderation of alcohol intake, optimal body weight, daily exercise by hypertension nurse and physician AND an additional one on one (family members allowed) one hour long counseling by certified dietician who will assess the patient's dietary habits, endorse and describe the Dietary Approach to Stop Hypertension (DASH) diet, and will establish four weekly half an hour follow ups by telephone to address compliance and any question raised by patient and family members.
16083407|NCT02283697|Other|Control: Standard Care|a standard endorsement of low salt diet and other non-pharmacological interventions such as moderation of alcohol intake, optimal body weight, daily exercise by hypertension nurse and physician
16083408|NCT02283684|Procedure|Greenlight laser PVP|Vaporization of the prostate adenoma using 532nm laser with 180W XPS system using Moxy fiber
16083409|NCT02283684|Procedure|Bipolar TUVP|Bipolar energy is used for generation of plasma that ends up by vaporization of the prostate adenoma
16083410|NCT02283671|Biological|Tolerogenic Dendritic cells loaded with myelin peptides|Somatic-cell therapy medicines application
16083411|NCT02283658|Drug|Everolimus|Given PO
16083412|NCT02283658|Other|Laboratory Biomarker Analysis|Correlative studies
16083413|NCT02283658|Drug|Letrozole|Given PO
16083414|NCT02283645|Drug|3 % minoxidil lotion|
16083415|NCT02283645|Drug|Placebo|
16083416|NCT02283632|Procedure|Jejunal Diversion|The jejuno-jejunostomy surgical procedure is a well-known general surgical operation performed for multiple acute and chronic conditions including Crohn's disease, ovarian cancer, and small bowel obstruction. The jejunal diversion procedure is an adaptation of a jejuno-jejunostomy. The proximal end of the anastomosis is approximately 100 cm distal from the ligament of Treitz. The distal end of the anastomosis is approximately 250 cm proximal from the ileocecal junction.
16083417|NCT02283619|Other|None - no intervention, observational study|No intervention, observational study
16083418|NCT02283606|Device|Accuvix SnonAce UGEO|vaginal ultrasonography
16083419|NCT02283593|Behavioral|eChange.se|7 modules: 1. Making a decisional balance 2. Setting a goal for alcohol consumption 3. Learning self control skills 4. Identifying risk situations 5. Dealing with urges 6. Dealing with emotions and with social pressure 7. Developing a crisis plan
16083420|NCT02283580|Other|Single limb|"Low load, high-repetitive resistance training.
~single limb at a time (e.g., one arm or one leg)
~elastic bands
~8 weeks
~3 times/week,
~each session 60 minutes
~seven resistance exercises: Latissimus row, leg curl, elbow flexion, chestpress, plantar flexion, shoulder flexion and knee extension
~maximal number of repetitions (RM) * 3 sets in each exercise."
16083421|NCT02283580|Other|Two limb|"Low load, high-repetitive resistance training.
~two limbs at a time (e.g., both arms or both legs)
~elastic bands
~8 weeks
~3 times/week,
~each session 60 minutes
~seven resistance exercises: Latissimus row, leg curl, elbow flexion, chestpress, plantar flexion, shoulder flexion and knee extension
~maximal number of repetitions (RM) * 3 sets in each exercise."
16083422|NCT02283554|Procedure|open flap debridement (OFD)|
16083423|NCT02283554|Other|Platelet rich fibrin (PRF)|
16083424|NCT02283554|Drug|Metformin|
16083425|NCT02283541|Behavioral|Automatic self-transcending meditation|ASTM is a category of meditation that helps quiet the mind and induce physiological and mental relaxation while the eyes are shut. It utilizes relaxed attention to a specific sound value (mantra) according to specific criteria, in order to draw attention inward.
16083426|NCT02283528|Device|Stryker Hybrid|Place Hybrid arch bars
16083427|NCT02283528|Device|Erich|Control group is Erich arch bars
16083428|NCT02283515|Drug|Rosuvastatin|Rosuvastatin (RSV) is one of new synthetic, second-generation, sulfur-containing, hydrophilic statin, a highly efficient competitive inhibitors of HMG CoA Reductase having important role in reducing serum cholesterol concentrations and lowers the risk of cardiovascular disease.
16083429|NCT02283502|Device|MRgHIFU system|Magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system for the noninvasive treatment of uterine fibroids
16083430|NCT02283489|Drug|recombinant human endostatin adenovirus|"Specification: 1mL/division, 1.0×1012 virus particle (VP). ESD01 preparation: Thaw at room temperature, dilute with normal saline to required volume (no more than 2 mL).
~Method of administration: Intratumor injection, once a week for 2 weeks, every 3 weeks for one cycle. Select only one target lesion even when lesions are present. The target lesion is the largest and easiest to inject. This will be fixed during the study."
16083431|NCT02283489|Drug|Cisplatin injection|Specification: 2ml: 10mg. Usage: 25mg/m2, days 1 to 3, according to instruction.
16083432|NCT02283489|Drug|Paclitaxel injection|Specification: 5ml: 30mg. Usage: 160mg/m2 intravenously on day 1, according to instruction.
16083433|NCT02283476|Drug|Endostar continuous intravenous infusion|Endostar,7.5mg/m2, continuous intravenous infusion for 14 days each cycle, 21 days as one cycle, 4 cycles in total.
16083434|NCT02283476|Drug|Endostar routine intravenous infusion|Endostar,7.5mg/m2, routine intravenous infusion 3-4 hours daily each cycle,21 days as one cycle, 4 cycles in total
16083435|NCT02283476|Drug|Gemcitabine|Gemcitabine,1000-1250mg/m2,i.v d1,d8 in each cycle,21 days as one cycle, 4 cycles in total
16083436|NCT02283476|Drug|Cisplatin|Cisplatin,75mg/m2,i.v d1 or d1-3 in each cycle,21 days as one cycle, 4 cycles in total
16083437|NCT02283463|Device|Intrauterine device (IUD) insertion|
16083438|NCT02283463|Procedure|Endometrial biopsy|
16083439|NCT02283450|Drug|Qiliqiangxin Capsule|
16083440|NCT02283437|Behavioral|Problem-solving Based Bibliotherapy Program|The PSBPF will complete the bibliotherapy (self-help) and problem-solving manual developed by the research team for caregivers of people with schizophrenia spectrum disorders.
16083441|NCT02283437|Behavioral|Behavioral Management and Education Program|Two trained advanced practice psychiatric nurses who are experienced in psychiatric rehabilitation and group programs will lead the behavioral management and education group, which is guided by a validated treatment protocol based on the research team's (Chien and Wong, 2007) and McFarlane et al.'s (2001) family management programs for schizophrenia.
16083442|NCT02283424|Drug|Icotinib|compared with chemotherapy,which is better for lung adenocarcinoma patients with epidermal growth factor receptor gene mutation after surgery
16083443|NCT02283424|Drug|chemotherapy (Carboplatin and Docetaxel)|as control group,compared with Icotinib
16083695|NCT02281552|Drug|Tofacitinib|tofacitinib immediate release 5 mg tablet administered twice a day for 12 weeks
16083444|NCT02283411|Device|Abbott Sensor Based Glucose Monitoring System|Subjects will wear the Abbott Sensor Based Glucose Monitoring Systems and will receive no treatment except for safety purposes.
16083445|NCT02283398|Other|without RIPC|the cuff will be placed around the left arm without being inflated
16083446|NCT02283398|Procedure|RIPC|RIPC will be induced with three cycles of inflation of a blood-pressure cuff on the left arm to 200 mm Hg for 5 min, followed by 5 min of reperfusion while cuff deflated
16083447|NCT02283385|Behavioral|PROTECT|8-session weekly psychotherapy intervention that combines problem-solving therapy, anxiety management and psycho education developed specifically for this population
16083448|NCT02283372|Drug|nab-Paclitaxel|
16083449|NCT02283372|Drug|Gemcitabine|
16083450|NCT02283372|Radiation|Intensity modulated radiation|
16083451|NCT02283359|Drug|Selinexor|Selinexor is a potent slowly reversible covalent Selective Inhibitor of Nuclear Export (SINE) that specifically blocks the karyopherin protein Exportin 1 or XPO1.
16083452|NCT02283359|Drug|Irinotecan|Irinotecan is a topoisomerase inhibitor and is approved by FDA to treat colorectal cancer. It is administered intravenously.
16083453|NCT02283346|Radiation|HDR brachytherapy + hypofractionated EBRT|"Single Fraction High Dose Rate (HDR) Brachytherapy One fraction with 10-15 Gray (Gy) (depending on normal tissues constraints).
~+ Hypofractionated External Beam Radiotherapy (EBRT) The treatment will be held with fractions 2.5 Gy per day, with a final dose between 25 and 50 Gy (depending on normal tissues constraints)."
16083454|NCT02283333|Behavioral|BATE-G|Behavioral Activation and Therapeutic Exposure - Grief therapy is delivered in 7 weekly sessions to the participant.
16083455|NCT02283333|Behavioral|Standard Treatment|Cognitive Restructuring and Supportive Grief Counseling is delivered in 7 weekly sessions to the participant.
16083456|NCT02283320|Drug|BIND-014 (Docetaxel Nanoparticles for Injectable Suspension)|
16083457|NCT02283307|Other|Reduced contrast DECT scan|Subjects will undergo a dual energy CT scan with reduced contrast
16083458|NCT02283307|Other|Standard contrast SECT scan|Subjects will undergo standard of care single energy CT scan with a standard dose of contrast. (control)
16083459|NCT02283294|Drug|Apixaban|
16083460|NCT02283294|Drug|Warfarin|
16083461|NCT02283281|Drug|Tetrahydrocannabinol|1:1 THC to CBD standardized extract from cannabis plant
16083462|NCT02283281|Drug|Dummy oromucosal|drops containing only Olive oil vehicle without the active compound (i.e.: without Cannabis oil)
16083463|NCT02283268|Biological|Recombinant von Willebrand Factor (rVWF)|rVWF will be administered by intravenous bolus infusion. Participants planned for major surgery will undergo a baseline pharmacokinetic assessment prior to surgery. The peri- and postoperative substitution regimen will be individualized according to the PK results, intensity and duration of the hemostatic challenge, and the institution´s standard of care.
16083464|NCT02283255|Other|Physical Activity|Physical Activity, Exercise training: aerobic and respiratory exercise with POWERbreathe device
16083465|NCT02283242|Drug|Galantamine|Oral use for 12 weeks
16083466|NCT02283242|Drug|Placebo (for galantamine)|Oral use for 12 weeks
16083467|NCT02283229|Behavioral|Newborns with preventive caring advices|Advices to prevent head molding
16083468|NCT02283229|Other|Newborns with normal caring advices|Normal handling
16083469|NCT02283216|Device|noise sound stimulation (Tucker-Davis Technologies)|Band-limited white noise stimulus, comfortable loudness level, presented via headphones or earphones with Tucker-Davis Technologies device.
16083470|NCT02283216|Device|body electrical stimulation (Digitimer device)|Single pulse electrical stimulation on different body regions, comfortable current level, presented via surface pads or clips with Digitimer device.
16083471|NCT02283216|Device|transcranial magnetic stimulation (Magstim)|Single pulse magnetic stimulation over frontal cortex, comfortable level at 110% resting motor threshold, presented via magnetic coil with Magstim device.
16083472|NCT02283203|Drug|APOTEL max|The study drug is provided in a form of bag with 100ml final volume and it is directly connected to the infusion device that leads to a catheter already cannulated in one antecubital vein.
16083473|NCT02283203|Drug|Placebo|Placebo is provided in a form of bag with 100ml final volume and it is directly connected to the infusion device that leads to a catheter already cannulated in one antecubital vein. Placebo contains water for injection and inactive vehicles.
16083474|NCT02283190|Drug|Erwinase|Six doses of Erwinase, given Monday-Wednesday-Friday for 2 weeks. Dosage levels to be used are: 20,000 IU/ m2 /day, 25,000 IU/ m2 /day, 30,000 IU/ m2 /day.
16083475|NCT02283177|Drug|crenolanib|
16083476|NCT02283177|Drug|cytarabine|
16083477|NCT02283177|Drug|daunorubicin|
16083478|NCT02283177|Drug|idarubicin|
16083479|NCT02283164|Behavioral|Hazardous materials online education and study feedback|Participants will receive a 45-minute educational webinar on hazardous materials handing best practices at the beginning of the intervention period. Subsequently they will receive quarterly feedback of interim study results.
16083480|NCT02283151|Dietary Supplement|diet nutrition bar|The experimental group was given individual instructions on how to follow the VLCD (very low carbohydrate diet). Energy intake was restricted to less than 800kcal/day (3349kJ/d) (carbohydrate intake < 20g/d). All daily meals were replaced as follows: a cup of soybean milk (200 mL) and a boiled egg at breakfast; a diet nutrition bar(Nutriease Health Technology Co., Ltd., Hangzhou, China), nonstarchy vegetables (<200 kcal), and 50 g protein from meat at lunch and dinner. Supplementation of multivitamins and minerals was provided per day.
16083481|NCT02283151|Other|energy-restricted diet|The control group was given an energy-restricted diet (ER diet). Energy-restricted diet was designed in the traditional Chinese style with an initial target for a total energy intake of 1200 kcal/d (5021 kJ/d).
16083482|NCT02283112|Other|antivirals, antimicrobials, oral contraceptive, erectile dysfunction agents|
16083483|NCT02283099|Biological|rVSVΔ-ZEBOV-GP|single dose of rVSVΔ-ZEBOV-GP (3x10^6 pfu, 2x10^7 pfu or 3x10^5)
16083484|NCT02283086|Behavioral|Physician Feedback Reporting|The performance feedback reports displayed both individual physicians' statistics as well as their performance compared to anonymized results for the entire group of emergency physicians.
16083485|NCT02283060|Drug|Stribild|To be administered orally, once daily with food.
16083486|NCT02283060|Drug|Atripla|To be administered orally, once daily at bedtime on an empty stomach
16083487|NCT02283047|Behavioral|DIET|Lifestyle intervention through hypocaloric diet
16083488|NCT02283047|Behavioral|DIET & MODERATE CONTINUOUS TRAINING|Lifestyle intervention through hypocaloric diet and exercise at moderate intensity (60-80%peakHR) continuous mode, and high volume (45 min).
16083489|NCT02283047|Behavioral|DIET & HIGH VOLUME HIIT|Lifestyle intervention through hypocaloric diet and exercise at high intensity (80-95%peakHR) interval mode, and high volume (45 min).
16083490|NCT02283047|Behavioral|DIET & LOW VOLUME HIIT|Lifestyle intervention through diet and exercise at high intensity (80-95%peakHR) interval mode, and low volume (20 min).
16083491|NCT02283034|Device|The CPRmeter|Feedback device - 1
16083492|NCT02283034|Device|The PocketCPR|Feedback device - 2
16083493|NCT02283034|Device|Standard BLS|Standard basic life support = chest compressions without any feedback device (manual resuscitation)
16083494|NCT02283034|Device|The CPREazy|Feedback device - 3
16083495|NCT02283034|Device|The CPR PRO APP|Feedback device - 4
16083496|NCT02283034|Device|The CardioPump|Feedback devices - 5
16083497|NCT02283034|Device|Standard BLS|Chest compressions without CPR feedback device (manual resuscitation)
16083498|NCT02283021|Other|A biopsy sample|Sample tissue will be obtained from the routine biopsy taken for pathological evaluation. A pathologist will determine which part of the tissue will be forwarded for this study, to avoid any interference with the pathological evaluation.
16083499|NCT02283008|Behavioral|Assessment of inhaler technique pre and 6 weeks post training|Assessment of inhaler technique on day one. Education package and training on inhaler use at week 2. Final assessment to establish maintenance of inhaler competence at week 8
16083500|NCT02282969|Behavioral|Interviews|Interviews performed by study staff encompassing lung cancer screening and patient decision aids.
16083501|NCT02282969|Behavioral|Questionnaires|Questionnaires completed after viewing patient decision aid video. Questionnaires also completed regarding lung cancer screening knowledge at first visit, then again in one month.
16083502|NCT02282956|Drug|Ropivacaine 0,75%|Ropivacaine injection
16083503|NCT02282956|Procedure|posterior tibial nerve block|ultrasound guided posterior tibal nerve block
16083504|NCT02282956|Drug|morphine and droperidol|i.v PCA
16083505|NCT02282943|Device|Laser|Vapourisation/excision of endometriosis AFS stages I-III using CO2 laser
16083506|NCT02282943|Device|Harmonic scalpel|Excision of endometriosis using Harmonic scalpel
16083507|NCT02282930|Drug|ACTH (Acthar) Gel|Injected dose of 80 units subcutaneously twice weekly for 6 months.
16083508|NCT02282917|Drug|AR-42|AR-42 will be administered in a total of ten oral doses, +/- 1 dose, at 40 mg/dose, will be self-administered by study participants at approximately 8:00pm (+/- 1 hour) for 3 weeks pre-operatively, with the last dose being administered the night before surgery. The treating surgeon will perform the clinically indicated surgical procedure 3 weeks post-initial dose of medication as well as the specimen collection.
16083509|NCT02282904|Drug|Sirolimus|"For pediatric patients: Begin sirolimus 1 mg/m2 PO q4h for 3 doses, then 1 mg/m2 once a day (QD). For adult patients, begin sirolimus 5 mg PO q4h for 3 doses, then 5 mg once a day (QD).
~Doses may be adjusted to maintain trough levels between 8-14 ng/ml. Recipients will take sirolimus from Day +5 to at least Day 100 (minimum)."
16083510|NCT02282904|Biological|Donor peripheral blood stem cells.|Infuse donor graft.
16083511|NCT02282904|Drug|Cyclophosphamide post transplant|50 mg/kg/d IV infused over 90 minutes. Day +3 and +4
16083512|NCT02282904|Radiation|Total body 200cGy|Day -1
16083513|NCT02282904|Drug|Cyclophosphamide|14.5 mg/kg IV over one hour Day -6 and -5
16083514|NCT02282904|Drug|Fludarabine|30 mg/m2 over 30 minutes Day -6 through Day -2
16083515|NCT02282904|Drug|Busulfan|Busulfan 3.2 mg/kg IV once daily over 2-3 hours Day -4,-3,-2
16083516|NCT02282891|Drug|Propofol|Induction of general anesthesia using propofol 2mg/kg
16083517|NCT02282891|Drug|Propofol-Ketamine|Induction of general anesthesia using a mixture of 1.5 mg/kg:0.75 mg/kg propofol/ketamine
16083518|NCT02282878|Dietary Supplement|High/Low Sodium Diet|All patients will receive 2 weeks of the high sodium diet followed by a 1 week washout and then 2 weeks of the low sodium diet
16083519|NCT02282852|Device|Wireless Capsule Endoscopy|
16083520|NCT02282852|Device|Magnetically steerable capsule endoscopy|
16083521|NCT02282839|Dietary Supplement|Glutamine|Powder that soluble in water for drinking, 10g TID (total 30 g per day)
16083522|NCT02282839|Dietary Supplement|Placebo|Powder that provided by manufacturer with the same ingredients yet without glutamine, TID use
16083523|NCT02282826|Drug|GZ402668|Pharmaceutical form:solution Route of administration: intravenous
16083524|NCT02282826|Drug|placebo|Pharmaceutical form:solution Route of administration: intravenous
16083525|NCT02282826|Drug|GZ402668|Pharmaceutical form:solution Route of administration: subcutaneous
16083526|NCT02282826|Drug|placebo|Pharmaceutical form:solution Route of administration: subcutaneous
16083527|NCT02282826|Drug|acyclovir|Pharmaceutical form:tablet Route of administration: oral
16083528|NCT02282813|Drug|CTAP101 Capsules|At week 12, eligible subjects will continue to take 1-2 capsules (30 mcg each capsule) CTAP101 daily
16083529|NCT02282813|Drug|Calcitriol|At week 12, eligible subjects will be randomized to also take calcitriol 0.25 mcg dose one capsule daily
16083530|NCT02282813|Drug|Doxercalciferol|At week 12, eligible subjects will be randomized to also take doxercalciferol 0.5 mcg one capsule daily
16083531|NCT02282813|Drug|Paricalcitol|At week 12, eligible subjects will be randomized to also take paricalcitol 1 mcg one capsule daily
16083532|NCT02282800|Genetic|Vitamin D receptor|50-100mg gingival tissue samples were collected from both test and control group for immunohistochemical staining to assess the number of vitamin D receptors in nucleus as well cytoplasm and also for RNA isolation to check the presence of VDR gene.
16083533|NCT02282787|Drug|DEXMEDETOMIDINE|Does adding 5 or 10 micron of DEXMEDETOMIDINE to peribulbar anesthesia is any different from regular peribulbar anesthesia practice?
16083574|NCT02282514|Drug|G-CSF|Granulocyte-colony stimulating factor; a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream
16083575|NCT02282514|Drug|Rituxan|A chimeric monoclonal antibody used in the treatment of B cell non-Hodgkin's lymphoma, B cell leukemia, and some autoimmune disorders
16083576|NCT02282501|Other|enteral feeding by nasogastric tube.|method of administration enteral feeding by nasogastric tube.
16083534|NCT02282774|Drug|2% lidocaine and 0.5% bupivacaine|Under general anesthesia and the operating microscope, a Lieberman lid speculum was placed and the conjunctiva was cleaned with 4% povidone iodine solution. The surgeon then created a fornix-based incision through conjunctiva and tenon's tissue inferonasally midway between the insertions of the medial and inferior rectus muscles, with blunt Wescott scissors to expose the scleral surface before tunneling posteriorly with curved Stevens scissors to create a small channel to the posterior subtenon space. A blunt-tipped subtenon cannula was then inserted into the posterior subtenon space, 4mL of 2% lidocaine and 0.5% bupivacaine (50:50) mixture versus saline was introduced and the drug solution was injected slowly into the subtenon space. After administration of local anesthetic mixture, the eyelid was gently taped down, and no ocular massage was performed
16083535|NCT02282774|Drug|Sham subtenon block|
16083536|NCT02282761|Drug|ITI-007|
16083537|NCT02282761|Drug|Placebo|
16083538|NCT02282748|Other|No intervention|
16083539|NCT02282722|Other|Investigational informed consent for chemotherapy|Investigational informed consent materials consist of regimen-specific multimedia tools: a video plus a booklet.
16083540|NCT02282722|Other|Usual, standard-of-care informed consent for chemotherapy|The enrolling site's institutional standard-of-care informed consent materials.
16083541|NCT02282709|Drug|Daclatasvir|60 mg once daily
16083542|NCT02282709|Drug|asunaprevir|100 mg BID
16083543|NCT02282696|Other|Questionnaire, focus group participation|participants of the quantitative part of the study are asked to fill in a questionnaire, participants of the qualitative part are asked to participate in a focus group interview.
16083544|NCT02282683|Drug|prednisone|Prednisone (10 to 20 mg/day, orally) combined with maximum tolerated guideline-directed medical therapy for at least 12 months
16083545|NCT02282670|Drug|DA-5204|
16083546|NCT02282670|Drug|Stillen tab.|
16083547|NCT02282657|Device|ECCO2R will be initiated during the 2-hour run-in time|"A single (15.5 to 19 Fr) veno-venous ECCO2R catheter will be inserted percutaneously (jugular vein strongly suggested).
~Catheters should be rinsed with heparinized saline solution before insertion Once the catheter has been inserted each line will be filled with an heparinized saline solution before its connection to the extracorporeal circuit The ECCO2R circuit will be connected to the catheter and blood flow set, depending on the device, up to 1000 mL/min.
~Initially, sweep gas flow through the ECCO2R device will be set at zero (0 LPM) such as to not initiate CO2 removal through the device.
~Anticoagulation will be maintained with unfractionated heparin to a target aPTT of 1.5 - 2.0X baseline. A bolus of heparin is suggested at the time of cannulation."
16083548|NCT02282657|Other|Neuromuscular blocking agents (NMBA)|Patients will receive NMBA starting in the run-in period and continued for the first 24 hours and thereafter will be directed by the attending physician
16083549|NCT02282657|Device|Ventilation|Following the 2-hour run-in time, VT will be reduced gradually to 5 mL/kg. Sweep gas initiated then VT decreased to 4.5 then 4 mL/kg and PEEP adjusted to reach 23 ≤ Pplat ≤ 25 cm H2O.
16083550|NCT02282657|Other|Level of carbon dioxide released at the end of expiration|EtCO2 will be monitored for safety purposes. Blood gases will be analyzed 20-30 minutes after each VT reduction
16083551|NCT02282657|Other|Respiratory Rate|RR will be kept what it was at baseline
16083552|NCT02282657|Other|Sweep gas flow|Sweep gas flow will be adapted to maintain the same EtCO2
16083553|NCT02282657|Other|Ventilation will be adapted|If PaCO2> 75 mmHg and/or pH < 7.2, despite respiratory rate of 35/min and optimized ECCO2R, VT will be increased to the last previously tolerated VT.
16083554|NCT02282657|Other|Respiratory rate will be adapted|If PaCO2 remains within the target range, respiratory rate will be progressively decreased to a minimum of 15/ min and facilitated by increases in sweep flow.
16083555|NCT02282644|Biological|Bone marrow sampling|
16083556|NCT02282631|Behavioral|Incentive scheme|Children who actively travel to school, full or partway, enter a weekly £5 voucher draw, whereby chances of winning are proportional to the number of trips as reported by the parent.
16083557|NCT02282618|Device|Cardiac Sympathetic Blockade|
16083558|NCT02282605|Drug|XF-73 nasal gel|
16083559|NCT02282605|Drug|Placebo nasal gel|
16083560|NCT02282605|Other|Chlorhexidine gluconate 2% topical cloths|
16083561|NCT02282592|Other|Observation about the presence of metabolic syndrome|
16083562|NCT02282579|Drug|Pazopanib|Non interventional study
16083563|NCT02282566|Other|Protein-nutrition beverage|Intervention involves consumption of one protein-nutrition beverage after exercise bout and 2 times per day for 5 days thereafter
16083564|NCT02282553|Device|Magnetically steerable pill camera (Microcam Navi, Intromedic Ltd, Seoul, Korea)|Capsule endoscopy uses a swallowable pill camera which passes through the GI tract by the action of peristalsis. The procedure utilizes a battery powered wireless capsule to transmit images of the gastrointestinal tract as it passes through the small intestine. The images are later downloaded to a computer and reviewed by a trained physician. Magnetically steerable gastric capsule endoscopy uses a pill camera containing a small amount of magnetic material, that can be manoeuvred in the gut and intestine by the physician using a handheld magnet.
16083565|NCT02282553|Device|Flexible endoscope|The current standard for investigation of upper gastrointestinal disorders is flexible endoscopy; oesophagogastroduodenoscopy (OGD), also known as gastroscopy.
16083566|NCT02282540|Procedure|Iodixanol to the Eustachian tube|Application of iodixanol to the middle ear for imaging of the ET.
16083567|NCT02282527|Biological|Liquid Alpha₁-PI|Liquid Alpha₁-PI, 60 mg/kg, 8 weekly intravenous infusions
16083568|NCT02282527|Biological|Prolastin-C|Prolastin-C, 60 mg/kg, 8 weekly intravenous infusions
16083569|NCT02282514|Biological|Autologous Hematopoietic Stem Cells|The stem cells will be collected from patient's blood during mobilization. Then the patient will be given high dose chemotherapy in accordance with approved recommendations for use in conditioning regimens for stem cell transplant in autoimmune diseases. Autologous Hematopoietic Stem Cell Transplantation is to re-infuse immature cells that can re-establish blood production and patient's immune system.
16083570|NCT02282514|Drug|Cyclophosphamide|An alkylating agent which causes prevention of cell division by forming adducts with DNA
16083571|NCT02282514|Drug|Mesna|Medication used to decrease the risk of hemorrhagic cystitis prophylaxis
16083572|NCT02282514|Drug|rATG|A predominantly lymphocyte-specific immunosuppressive agent which contains antibodies specific to the antigens commonly found on the surface of T cells
16083580|NCT02282462|Other|Unreg Pressure|Unregulated Suction using a traditional system (multi-chambered system e.g. Pleur-Evac, Atrium-Maquet or similar device as is routine at each institution)
16083581|NCT02282462|Other|Active Suction (Dig)|Thopaz+ digital chest drainage device set at -20cmH2O at the patient
16083582|NCT02282462|Other|Active Suction (Trad)|Pleur-Evac, Atrium-Maquet or similar set at -20cmH2O at the device.
16083583|NCT02282462|Other|Passive Drainage (Dig)|"Thopaz+ digital chest drainage device set at -8cmH2O at the patient (physiologic)"
16083584|NCT02282462|Other|Passive Drainage (Trad)|"Pleur-Evac, Atrium-Maquet or similar set by gravity (water-seal')"
16083585|NCT02282449|Device|Power Injectable Port (AngioDynamics Smart Port CT Mini)|The subjects will all receive power injectable port.
16083586|NCT02282449|Device|Non-Power Injectable Port (Cook Vital Mini Port)|The subjects will all receive non-power injectable port.
16083587|NCT02282436|Other|No specific intervention for this study|No specific intervention for this study
16083588|NCT02282423|Behavioral|Pre-study dietary and exercise instruction.|All subjects will be instructed to continue their normal diet during the three days prior to study, to not consume alcohol the day before study, and to not engage in exercise for 48 hours before all studies.
16083589|NCT02282423|Procedure|Screening examination and oral glucose tolerance test|All subjects will have screening exam and OGTT at the Clinical Studies Infusion Unit at Mayo Clinic in Arizona at 7-8 am after having eaten nothing after 10 PM the night before, and have a screening examination and 75 g OGTT, as described
16083590|NCT02282423|Procedure|Euglycemic clamp|On a separate day, subjects will have a two-hour euglycemic clamp ((80 mU insulin/(m2.min)) at the Clinical Studies Unit at Mayo Clinic Arizona at 7-8 am after an overnight fast. A muscle biopsy will be taken before the insulin infusion, to serve as the resting biopsy (3). Biopsy specimens (150-300 mg) will be frozen immediately in liquid nitrogen and stored in liquid nitrogen until they are processed
16083591|NCT02282423|Procedure|VO2max.|VO2max.
16083592|NCT02282423|Behavioral|Acute exercise bout|The single acute exercise bout will be performed as described (3). It consists of 4 sets of 12 min each (8 min @ 70% VO2max, 2 min @ 90%, 2 min rest, repeat X 4). Biopsies are taken 30 min and 24 hr after end of exercise. Resting biopsies are taken on the glucose clamp day
16083593|NCT02282423|Procedure|Percutaneous needle muscle biopsies|Skeletal muscle biopsies, blotted free from blood, are frozen within 30 seconds in liquid nitrogen, and stored in liquid nitrogen until processing. We routinely obtain 150-300 mg muscle (wet weight), which is more than sufficient for the analyses proposed, with some muscle remaining for any additional validation assays that may arise during the course of the research. Muscle will be processed either for isolation of mRNA/microRNA or protein, as described (2, 3, 12).
16083594|NCT02282410|Drug|ADVATE|The baseline ABR will be assessed from bleeding log and clinic records from preceding year. Subjects will initially be treated standard prophylaxis(20 - 40 IU/Kg body weight 2-3 times one week with ADVATE for 1 year.
16083595|NCT02282397|Device|Continuous Glucose Monitor|RT-CGM are adjunctive devices with glucose trend graphs and user-configurable low and high glucose alerts.
16083596|NCT02282384|Drug|oseltamivir|They will be assessed for eligibility at the clinics and those randomized to the intervention will receive oseltamivir 75 mg orally twice daily for 5 days within 72 hours of symptom onset. Participants randomized to the control group will receive calcium carbonate placebo pills twice daily for five days within 72 hours of symptom onset. For patients with a known creatinine clearance < 10 ml/min, the recommended dose of 75mg orally daily for 5 days of either intervention or placebo will be administered.
16083597|NCT02282384|Other|Placebo|
16083601|NCT02282358|Drug|Mocetinostat|
16083602|NCT02282345|Other|Laboratory Biomarker Analysis|Correlative studies
16083603|NCT02282345|Drug|Talazoparib|Given PO
16083604|NCT02282332|Drug|Ticagrelor|
16083605|NCT02282319|Drug|spinal dexmedetomidine 0.5 mcg|Administration of dexmedetomidine 0.5 mcg
16083606|NCT02282319|Other|spinal chloroprocaine 40 mg|spinal anesthesia with chloroprocaine 40 mg
16083607|NCT02282319|Drug|IV dexmedetomidine 0.5 mcg/kg|intravenous administration of dexmedetomidine 0.5 mcg/kg
16083608|NCT02282306|Behavioral|TTIP-PRO|The peer-delivered TTIP-PRO intervention is designed to: 1). increase the patient's knowledge of risk factors for OOD, with a particular emphasis on the patient's personal risk factors. This aim is one of harm reduction and is intended to help patients who continue to abuse opioids to use in a safer manner and 2).For patients who are open to considering treatment, to encourage the patient to get treatment for his/her opioid use disorder. This goal is based on research findings that effective treatment reduces the risk of OOD.
16083609|NCT02282293|Drug|Monthly dihydroartemisinin-piperaquine (DP) + daily trimethoprim/sulfamethoxazole (TS)|
16083610|NCT02282293|Drug|Monthly placebo + daily trimethoprim/sulfamethoxazole (TS)|
16083611|NCT02282280|Drug|Prilocaine Chlorhydrate|Use of prilocaine in spinal anesthesia
16083612|NCT02282267|Drug|Gefitinib|Iressa 250mg oral daily
16083613|NCT02282254|Other|Overnight intervention|Subjects will be admitted at the research facility at 19:00. A cannula will be inserted into an arm or a hand vein for blood sampling purposes. On dual-hormone closed-loop visits, glucagon will be reconstituted according to the manufacturer's instructions and a MiniMed® Paradigm® Veo™ pump containing the glucagon solution will be installed. At 20:30, a snack containing 20g of carbohydrate will be given. Closed-loop strategy will start at 20:00 until 7:00 next morning. A glucose sensor reading will be entered manually in a tablet every 10 minutes. The tablet will generate a recommendation for the basal rates of insulin delivery and glucagon mini-boluses (glucagon recommendations will only be generated during the dual hormone closed-loop visits). Pumps' parameters will then be changed manually to implement the tablet generated recommendations.
16083614|NCT02282241|Drug|Melatonin|
16083615|NCT02282241|Other|Placebo|
16083616|NCT02282228|Device|Medfield Strokefinder MD100|Measurement with Medfield Strokefinder MD100.
16083617|NCT02282215|Biological|CLT-008|Single intravenous infusion
16083618|NCT02282215|Biological|G-CSF|Daily subcutaneous injections
16083696|NCT02281539|Device|Neuromotus|
16083697|NCT02281526|Drug|BIA 2-093|
16083747|NCT02281136|Device|BLU-U|10 J/cm2 of 417 nm blue light delivered at 10 mW/cm2
16083619|NCT02282202|Device|Oscillating Positive Expiratory Pressure (Aerobika ®)|"The oPEP system (Aerobika ®) combines positive expiratory pressure therapy and airway vibrations to help mobilize pulmonary secretions. oPEP therapy (Aerobika ®) enforces a resistance to exhalation at the mouth, while the airway vibration technology transmits movements upstream during exhalation so that airway walls may become free from mucous. Subjects will take home the device and use four times daily during the active part of the study.
~There is only one intervention for this study. Subjects are on treatment for three weeks and off for the alternate three weeks."
16083620|NCT02282189|Device|Oscillating Positive Expiratory Pressure (Aerobika ®)|The oPEP system combines positive expiratory pressure therapy and airway vibrations to help mobilize pulmonary secretions. oPEP therapy enforces a resistance to exhalation at the mouth, while the airway vibration technology transmits movements upstream during exhalation so that airway walls may become free from mucous. Subjects will take home the device and use four times daily during the active part of the study.
16083621|NCT02282176|Drug|Azithromycin|Azithromycin IV 10mg/kg daily for 10 days
16083622|NCT02282176|Drug|Placebo|Azithromycin placebo (5% Dextrose) daily for 10 days
16083623|NCT02282163|Drug|sulphur hexafluoride lipid-type A microspheres|Ultrasound imaging contrast agent
16083624|NCT02282150|Drug|Hydrocortisone|Usual hydrocortisone dosage regimen; 10-40 mg hydrocortisone administered twice or thrice daily for 5 weeks
16083625|NCT02282150|Drug|Plenadren|10-40 mg modified-release hydrocortisone in tablets, once a day for 16 weeks
16083626|NCT02282137|Drug|68Ga-PSMA|Patients with suspected prostate cancer recurrence and non-informative bone scintigraphy, computerized tomography (CT) or magnetic resonance imaging (MRI). Suspected prostate recurrence is based upon elevated blood prostate specific antigen (PSA) levels following initial therapy.
16083627|NCT02282124|Behavioral|Self-management program with monthly sessions|Patients participate in 9 sessions during the first 8th month after transplantaiton
16083628|NCT02282124|Behavioral|Usual Care, containing one session|Session takes place within the first three months after transplantation
16083629|NCT02282111|Device|22-gauge Procore needle (ProCore, Cook Medical Inc., Winston-Salem, NC)|Using a linear EUS with color and pulsed Doppler to scan the area for vessels, the lesion was then sampled with a 22-gauge beveled needle (using the slow capillary suction and fanning techniques with 5 to 15 to-and-fro movements with each pass). A total of 4 passes were performed and after that, the procedure terminated.
16083630|NCT02282111|Device|conventional needle-knife sphincterotome (Microknife XL; Boston Scientific Inc, Natick, Mass)|Using a conventional needle-knife sphincterotome connected to an electrosurgical unit, and under direct endoscopic vision, a 6-12mm linear incision was made from the periphery of the lesion to its highest convexity zone. A conventional biopsy forceps was then deeply introduced through the hole, and 2 bites were obtained per pass. A total of 4 passes were performed by passing the biopsy forceps through the incision on each occasion. The mucosal incision was then closed with endoclips whenever possible.
16083631|NCT02282098|Drug|Colchicine|Colchicine 0.6mg twice daily
16083632|NCT02282098|Drug|Placebo|Placebo Colchicine
16083633|NCT02282085|Drug|Aripiprazole Once-Monthly|
16083634|NCT02282085|Drug|Oral Antipsychotic (i.e. aripiprazole, risperidone, lurasidone, quetiapine, olanzapine, ziprasidone, etc)|Oral antipsychotic medication
16083635|NCT02282072|Device|Deep brain stimulation：PINS Stimulation System|
16083637|NCT02282033|Device|The Moderato System|The BackBeat Moderato System incorporates traditional pacing modes and algorithms to provide pacing support to patients with all conditions currently indicated for dual chamber pacing. In addition, a special pacing algorithm was developed to reduce blood pressure.
16083638|NCT02282020|Drug|OLAPARIB|300 mg olaparib tablets taken orally twice daily. All patients should continue to receive study treatment until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator or the patient experiences unacceptable toxicity or they meet any other discontinuation criteria.
16083639|NCT02282020|Drug|Single agent chemotherapy|Treatment of relapsed disease with single agent chemotherapy based on physician's choice of weekly paclitaxel, topotecan, pegylated liposomal doxorubicin, or gemcitabine. All patients should continue to receive study treatment until objective radiological disease progression as per RECIST 1.1 as assessed by the investigator or the patient experiences unacceptable toxicity or they meet any other discontinuation criteria
16083640|NCT02282007|Behavioral|Individual NPMP to the participants|The participants in the intervention group will receive NPMP individually adjusted for six months. NPMP is not a standardized treatment approach, but individually adjusted to the individual patient according to their individual problems.
16083642|NCT02281981|Dietary Supplement|Curcumin|333mg CurcuWin OAHTCUR002-2014
16083643|NCT02281981|Dietary Supplement|Placebo|OAHTCUR005-2014
16083644|NCT02281968|Drug|Naproxen|Standing regimen of naproxen in experimental group to reduce need for narcotic to control pain
16083645|NCT02281968|Drug|Placebo|
16083646|NCT02281955|Radiation|Intensity Modulated Radiotherapy (IMRT)|All patients will receive Intensity Modulated Radiotherapy Treatments (IMRT). Dose painting IMRT will be used and all doses will be specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) will be treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR will be 2 Gy per day and 1.8 Gy per day respectively. The PTV-HR will include the gross tumor and the PTV-SR will include areas at risk for harboring subclinical microscopic disease.
16083647|NCT02281955|Drug|Cisplatin (or alternative)|Cisplatin is the preferred mandated first choice chemotherapy, however alternative weekly regimens are permissible. Justification for not using cisplatin must be documented. Chemotherapy will be given intravenously weekly during IMRT. 6 total doses will be given. It is preferred that the doses be administered on days 1, 8, 15, 22, 29, and 36; however, this is not mandatory. Chemotherapy will not be given to patients with T0-2 N0-1 disease, ≤ 10 pack years smoking history.
16083698|NCT02281513|Other|Smartphone Application|Is a self-monitoring tool to document fruit and vegetable consumption, sleep quantity and quality, and physical activity
16083648|NCT02281955|Procedure|Assessment for surgical evaluation|Decisions for surgical evaluation will be based on the results of the PET/CT 10 to 16 weeks after CRT and clinical exam (including fiberoptic laryngoscopy) at that time. Other optional imaging studies may be performed. Patients with a positive PET/CT scan will undergo surgical evaluation at the discretion of the surgeon, with the goal being to remove any suspected residual tumor with a negative resection margin while maintaining organ preservation. This may include biopsies and/or oncological resections of the primary tumor and lymph node metastases. Patients with a negative PET/CT scan will be observed.
16083649|NCT02281942|Behavioral|Yoga|
16083650|NCT02281942|Behavioral|Education|
16083651|NCT02281929|Drug|Amoxicillin|Amoxicillin+clavulanic acid at a daily dose of 3 gram / 375 mg in three daily doses of 1g/125mg, during 30 days
16083652|NCT02281929|Drug|Placebo|Placebo in three daily doses during 30 days
16083653|NCT02281929|Drug|Prednisolone|Prednisolone at 40 mg/j in a single daily dose in the morning, during 30 days
16083654|NCT02281916|Drug|P28GST|3 injections of 100 µg of P28GST within 3 months (one injection per month)
16083655|NCT02281903|Device|The TrueCPR feedback device|feedback devices
16083656|NCT02281903|Device|Standard BLS|Standard basic life support = chest compressions without any feedback device (manual resuscitation)
16083657|NCT02281890|Other|Proven sepsis|Exposure is proven sepsis
16083658|NCT02281877|Procedure|Neuromuscular electrical stimulation (NMES)|5x/week, 2x/day, for 45 minutes/session
16083659|NCT02281877|Behavioral|Standard Rehabilitation Protocol|Standard physical therapy after TKA
16083660|NCT02281864|Behavioral|Smoking Cessation Intervention Bundle|Receipt of the smoke cessation/reduction intervention bundle followed by referral to the Quitline.
16083661|NCT02281864|Other|Control Group: Quitline|Referral to the Quitline
16083662|NCT02281838|Drug|labetalol/hydralazine/enalapril|Blood pressure will be treated with intravenous labetalol (10 mg starting dose)/hydralazine (5 mg starting dose)/enalapril (1.25 mg starting dose).
16083663|NCT02281812|Procedure|Radiofrequency ablation|After tumor ablation and excision of the tumor, the pathologist performed a macroscopic study of the specimen,measuring the distance between the tumor and the margin in order to indicate if extensions are mandatory. Secondly and delayed, margins will be evaluated microscopically by H&E stain. Furthermore, the tumoral viability in the ablation zone will be evaluated by NADH-diaphorase, COX and tunnel.
16083664|NCT02281799|Drug|Azathioprine|"Patients will be commenced on an alternative thiopurine to that used initially, according to the standard dosing schedule used by their IBD clinician.
~For example, if the initial thiopurine-related pancreatitis occurred while taking Azathioprine, the patient will be restarted on 6-MP, and vice versa."
16083665|NCT02281786|Drug|Placebo|Matching placebo to RO6926496
16083666|NCT02281786|Drug|RO6926496|single, ascending dose, intravenous administration
16083667|NCT02281773|Drug|BI 409306 100 mg QD|
16083668|NCT02281773|Drug|BI 498306 50 mg QD|
16083669|NCT02281773|Drug|Placebo|
16083670|NCT02281773|Drug|BI 498306 25 mg QD|
16083671|NCT02281773|Drug|BI 409306 10 mg QD|
16083672|NCT02281760|Drug|Dabrafenib Mesylate|Description: Dabrafenib mesylate (GSK2118436B) is a potent and selective BRAF kinase inhibitor. This inhibition suppresses downstream activity of pERK, a biomarker, and has antiproliferative activity against BRAF mutant tumors.The mode of action is consistent with ATP competitive inhibition.
16083673|NCT02281760|Drug|Trametinib Dimethyl Sulfoxide|Trametinib dimethyl sulfoxide is a reversible, highly selective, allosteric inhibitor of mitogen-activated extracellular signal regulated kinase 1 (MEK1) and MEK2. Tumor cells commonly have hyperactivated extracellular signal-related kinase (ERK) pathways in which MEK is a critical component. Trametinib dimethyl sulfoxide inhibits activation of MEK by RAF kinases and MEK kinases.
16083674|NCT02281721|Device|Surpass Flow Diverter(s)|Endovascular placement of a Surpass Flow Diverter(s) for the treatment of an intracranial aneurysm(s)
16083675|NCT02281708|Drug|vinorelbine plus cisplatin|"Drugs will be administered for 4 cycles, and should be administered at scheduled day +/- 3 days
~vinorelbine 25mg/m2 IV (Day 1, 8) q 3wks cisplatin 75mg/m2 IV (Day 1) q 3wks"
16083676|NCT02281695|Other|PEEP adjusment during the Weaning process|The PEEP will be adjusted after an previously established algorithm and the differences in the arterial blood oxygen partial pressure will be compared.
16083677|NCT02281682|Drug|Imiquimod|three times a week once daily during 4 consecutive weeks. Prior to treatment: curettage
16083678|NCT02281682|Drug|5-fluorouracil|during 4 (consecutive) weeks twice daily. Prior to treatment: curettage
16083679|NCT02281682|Drug|Ingenol mebutate|during 3 (consecutive) days once daily. Prior to treatment: curettage
16083680|NCT02281682|Procedure|methylaminolevulinate photodynamic therapy|methylaminolevulinate photodynamic therapy; one session. Prior to treatment: curettage
16083681|NCT02281669|Drug|Pentostam|Intralesional injection of Pentostam
16083682|NCT02281656|Procedure|Surgery:ulnar nerve transposition with AIN to ulnar nerve transfer|
16083683|NCT02281656|Procedure|Surgery:ulnar nerve subcutaneous transposition without AIN to ulnar nerve transfer.|
16083684|NCT02281643|Drug|Doxycycline|200mg oral doxycycline will be administered immediately (early) in the experimental arm or delayed in the comparator arm
16083685|NCT02281630|Drug|KWA-0711|
16083686|NCT02281630|Drug|Placebo|
16083687|NCT02281617|Behavioral|Smart-device apps as memory aids|Patients will be taught to use software running on smartphones and smart tablets to help compensate for memory difficulties
16083688|NCT02281591|Drug|BIA 2-093|Tablets containing 900 mg
16083689|NCT02281591|Drug|S-licarbazepine|capsules containing 225 mg
16083690|NCT02281591|Drug|R-licarbazepine|capsules containing 225 mg
16083691|NCT02281578|Behavioral|Community-based combination HIV prevention intervention|The combination package will include integrated biomedical, behavioral and structural components: (1) mobile HIV testing and risk reduction counseling; (2) service navigation to facilitate access to treatment and retention in care; (3) sensitivity training for HIV clinical care providers; (4) SMS text messages to promote adherence to care and ART; (5) venue-based peer education and condom distribution; and (6) a community drop-in-center to promote cohesion and collective action to reduce stigma and discrimination.
16083692|NCT02281578|Behavioral|Standard of care HIV services|Locally available standard of care HIV prevention, treatment and care services
16083965|NCT02279680|Behavioral|Neuropsychological assesments|
16083699|NCT02281513|Other|Fitbit Activity Monitor|Is connected to this smartphone application so that participants who wear this monitor have data that automatically populates the smartphone application for physical activity.
16083700|NCT02281513|Other|Coaching Sessions|Using motivational interviewing (a counseling style used in helping persons change their behavior) at baseline after completion of all baseline assessments and at follow up after completion of all follow up assessments. Coaching session includes discussion of facilitators and barriers to increasing physical activity, fruit and vegetable consumption and sleep, as well as setting goals to work towards at next meeting. The coach will monitor the information that the participant enters into the smartphone application and will provide feedback on a weekly basis to the participant.
16083701|NCT02281500|Biological|Human Plasma-Derived Fibrinogen Concentrate|A sterile freeze-dried fibrinogen concentrate filled in vials containing 1 g of FIB Grifols. FIB Grifols contains 20 mg/ml of active substance fibrinogen when reconstituted.
16083702|NCT02281487|Procedure|Hysterectomy plus Tubectomy|hysterectomy with tubectomy
16083703|NCT02281487|Procedure|Hysterectomy|standard hysterectomy
16083704|NCT02281487|Device|light microscopy|analysis of the incidence of dysplastic lesions (defined as: nuclear atypia, pilling of epithelial cells, multiple mitosis), if any, in the removed Fallopian tubes by light microscopy (Leica DM4000)
16083705|NCT02281474|Drug|Nilotinib|
16083706|NCT02281461|Device|Male circumcision using a non-surgical device|Male Circumcision
16083707|NCT02281448|Drug|BIA 2-093|
16083708|NCT02281448|Drug|Contraceptives, Oral, Combined|
16083709|NCT02281435|Device|PrePex™ device|PrePex™ device for adult male circumcision. The PrePex™ device facilitates adult male circumcision that is bloodless with no anesthesia and no sutures, but in this study the procedure consist an incision on to the foreskin.
16083710|NCT02281422|Drug|BIA 2-093|
16083711|NCT02281409|Biological|Mogamulizumab (KW-0761)|
16083712|NCT02281396|Biological|2.5IU/ml in rabies vaccine （MRC-5 Cell) humans aged 10-20 years old|Freeze-dried Rabies Vaccine（MRC-5 Cell) of 2.5IU/ml,5 doses,4 weeks interval
16083713|NCT02281396|Biological|2.5IU/ml rabies vaccine （MRC-5 Cell) in humans aged 21-60 years old|Freeze-dried Rabies Vaccine（MRC-5 Cell) of 2.5IU/ml,5 doses,4 weeks interval
16083714|NCT02281396|Biological|2.5IU/ml rabies vaccine （MRC-5 Cell) in humans(from 10-20 years old)|Freeze-dried Rabies Vaccine（vero Cell) of 2.5IU/ml,5 doses,4 weeks interval
16083715|NCT02281396|Biological|2.5IU/ml rabies vaccine （MRC-5 Cell) in humans(from 21-60 years old)|Freeze-dried Rabies Vaccine（vero Cell) of 2.5IU/ml,5 doses,4 weeks interval
16083716|NCT02281383|Biological|Bacillus Calmette-Guérin (BCG)|
16083717|NCT02281370|Drug|Eltrombopag|White to off white bi-convex round tablets containing eltrombopag 50 mg for oral administration
16083718|NCT02281370|Drug|Cyclosporine|Soft gelatine capsule containing cyclosporine 100 mg for oral administration. Cyclosporine will be administered at the doses of 200 mg (2 x 100 mg capsules) or 600 mg (6 x 100 mg capsules)
16083719|NCT02281357|Biological|Tralokinumab|Tralokinumab dose
16083720|NCT02281357|Other|Placebo|Placebo dose
16083721|NCT02281344|Drug|MMV390048 20mg|Supplied as a powder to be prepared as a suspension for oral use
16083722|NCT02281331|Dietary Supplement|Supplement|supplement/placebo plus exercise training
16083723|NCT02281318|Biological|Mepolizumab|Humanised Immunoglobulin G (IgG) antibody (IgG1, kappa) with human heavy and light chain frameworks, provided as a lyophilised cake in sterile vial. Vial to be reconstituted with sterile water for injection, just prior to use
16083724|NCT02281318|Drug|Placebo|Sterile 0.9% sodium chloride solution
16083725|NCT02281318|Drug|SOC|Standard of Care (SOC) will differ by participants, however it will include high dose ICS with at least one other controller, e.g. LABA, with or without maintenance OCS
16083726|NCT02281305|Drug|Colchicine|
16083727|NCT02281292|Biological|LKA651 ophthalmic solution|
16083728|NCT02281292|Biological|Ranibizumab ophthalmic solution|
16083729|NCT02281292|Biological|Sham injection|Mock injection administered as an empty hub without needle
16083730|NCT02281279|Biological|rituximab|Given IV
16083731|NCT02281279|Drug|lenalidomide|Given PO
16083732|NCT02281279|Drug|romidepsin|Given IV
16083733|NCT02281279|Other|laboratory biomarker analysis|Correlative studies
16083734|NCT02281266|Procedure|curative resection|
16083735|NCT02281266|Drug|thymalfasin|1.6mg twice a week, 12 months
16083736|NCT02281266|Drug|nucleoside analog (suggest to use entecavir)|
16083737|NCT02281253|Dietary Supplement|dietary fibre plus L-carnitine bread|"The enriched bread consisted of a mix of wheat flour, vegetable flour, rye flour, wheat gluten, soy protein, soluble and insoluble dietary fibre, inulin, guar gum, L-carnitine salt, diacetyl tartaric, enzymes, ascorbic acid, water and yeast.
~Patients were recommended to consume the bread twice per day with main meals."
16083738|NCT02281253|Dietary Supplement|Placebo bread|The placebo group received commercially available bread with a similar macronutrient composition and energy intake to that consumed by the enriched bread group but without L-carnitine and dietary fibre. Patients were recommended to consume the bread twice per day with main meals.
16083739|NCT02281240|Drug|thrombopoietin, interleukin-11, heparin,|The hemostatic and antithrombotic (thrombopoietin, interleukin-11, heparin) measures during HSCT.
16083740|NCT02281227|Procedure|skin compression|skin compression with an indicator for determination of needle entry point
16083741|NCT02281214|Other|blood sample, biopsy|Blood samples and tumor biopsies will taken from patients before treatment and when tumor progression on therapy for Next Generation Sequencing (NGS) mutation analysis
16083742|NCT02281201|Biological|BE1116 (Prothrombin Complex Concentrate)|
16083743|NCT02281175|Behavioral|Psychosocial intervention|Based on a cognitive-behavioral approach, the psychosocial intervention (PASSE-65+) is specifically designed to help older BZD users to better manage their withdrawal symptoms, to stop their medication, and to improve their general psychological well-being
16083744|NCT02281175|Behavioral|a weekly physician intervention|Informative document + 12 meetings (once a week; 30 minutes) with a physician who will supervise the gradual withdrawal
16083745|NCT02281162|Other|Blood Draw|Blood Draw
16083746|NCT02281136|Drug|Aminolevulinic Acid (ALA)|20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
16083966|NCT02279667|Drug|BIA 2-093|oral suspension 50 mg/mL
16083748|NCT02281123|Other|SF36 (QQoL)|use of quality of life questionnaire (SF 36) ( at enrollment visit, at 3 month, at 6 month and at12 month for the following visits)
16083749|NCT02281110|Device|iFR/FFR|• The Volcano iFR®-FFR option, which is a measurement modality for the Volcano system that provides the capability to make FFR and instantaneous wave-Free Ratio™ (iFR®) measurements (CE-Marked). iFR® is a pressure-derived, hyperemia-free index for the assessment of coronary stenosis relevance. This option consists of an FFR-iFR® specific patient interface module (PIM-FFR) which can be connected to the Volcano system - VOLCANO s5 or s5i™ platform equipped with iFR® option. This PIM-FFR is compatible with all Volcano pressure measurement guide wires.
16083750|NCT02281097|Other|Stimulation|Application of current to skin above auricular branch of vagal nerve to modulate heart rate and symptoms
16083751|NCT02281097|Other|Placebo|Application of low intensive current or frequency to skin above auricular branch of vagal nerve as sham intervention
16083752|NCT02281084|Drug|Oral Azacitidine|Oral azacitidine (AZA) 100 mg, 150 mg, or 200 mg tablets twice daily (BID) on days 1 to 21 of each 28-day treatment cycle. Participants continued to receive their assigned study treatment unless disease progression, unacceptable toxicity, lost to follow-up or withdrawal by participant occurred.
16083753|NCT02281084|Drug|Durvalumab|Durvalumab 1500 mg by IV infusion on Day 1 of each 28 day treatment cycle.
16083754|NCT02281071|Procedure|laterally moved coronally advanced flap with microsurgical instruments and x2.5 loupe|The recipient area for the laterally moved flap was prepared. When the flap was moved in the distal-mesial direction another short horizontal incision was performed at the most apical extension of this vertical incision. Once the mucogingival line was reached, flap elevation was continued split-thickness. Flap elevation was terminated when it was possible to passively move the flap laterally above the exposed root. Flap was sutured.
16083755|NCT02281058|Drug|Abatacept|self-injected subcutaneous biologic medication
16083756|NCT02281045|Device|EVODIAL dialyzer and Selectbag citrate|Evodial is a trademark of Hospal-Gambro.
16083757|NCT02281045|Device|Regional citrate anticoagulation|Regional citrate anticoagulation is performed according to local practice, using a calcium-containing dialysate
16083758|NCT02281032|Other|interRAI PC|"PREPARATORY PHASE
~Step 0: Introductory information
~Step 1: Training on the interRAI PC and the BelRAI webapplication
~Step 2: Introduction on the interRAI PC and the BelRAI webapplication in the organization
~IMPLEMENTATION PHASE
~Step 3: Identification of residents with palliative care needs, based on the surprise question
~Step 4: Informed consent signature requirements
~Step 5: Login to the BelRAI webapplication
~Step 6: Definitions of roles and functions
~Step 7: Completion of the interRAI PC
~Step 8: Interpretation of results
~Step 9: Use of results"
16083759|NCT02281019|Procedure|ERCP (Endoscopic Retrograde Cholangiopancreatography)|ERCP procedure will be performed to visualize bile ducts.
16083760|NCT02281019|Device|SpyGlass DVS and SpyGlass Digital Simple (DS)|Cholangioscopy using SpyGlass™ DVS or SpyGlass DS will be performed post ERCP for direct viewing of the bile ducts. What is seen during the procedure will determine a course of treatment. Among the options are biopsies taken, stones treated/removed, or a stent placed
16083761|NCT02281006|Drug|Trans-tympanic injection of a sodium thiosulfate gel|A sodium thiosulfate hyaluronate gel will be prepared by mixing 0.55 ml of a 25% solution of sodium thiosulfate pentahydrate (Seacalphyx, DIN 02386666, Seaford Pharmaceuticals Inc.) and 0.55 ml of a hyaluronate gel (Healon 10 mg, Abbott Medical Optics Inc.). On the day before each Cisplatin treatment an otologist will deposit 0.1 ml of the gel exactly on the round window of the middle ear.
16083762|NCT02280993|Drug|DHAP|DHAP
16083763|NCT02280993|Drug|Brentuximab Vedotin|Brentuximab Vedotin
16083764|NCT02280993|Other|Autologous Peripheral Blood Stem Cell Transplantation|Autologous Peripheral Blood Stem Cell Transplantation
16083765|NCT02280980|Other|Oculomotor and Gaze Stability Exercises|Daily oculomotor and gaze stability exercises, twice a day, for three weeks
16083766|NCT02280967|Behavioral|Education about HPV by school nurse|Information about prevention of HPV among adolescents aged 16 at time for the regular health interview with the school nurse.
16083767|NCT02280954|Drug|Indocyanine Green (ICG)|
16083768|NCT02280941|Other|single photon emission computed tomography|Single photon emission computed tomography (SPECT) imaging will be done.
16083769|NCT02280928|Other|Balance exercise|Balance activities, using a task-oriented approach, progress participants from body stability, to body stability plus hand manipulation, then body transport, and finally body transport plus hand manipulation.
16083770|NCT02280928|Other|Cognitive training|Cognitive training involves executive function, attention, and working memory. Examples of cognitive training include finding the exit to a maze, calculation, visual-spatial skills, Sudoku, Stroop color-word task, word search, spot the differences, visual discrimination, and memory scanning skills.
16083771|NCT02280928|Other|Dual-task cognitive-cognitive training|The Dual-task cognitive-cognitive training involves applying two cognitive tasks at the same time.
16083772|NCT02280915|Other|Savoury food product|
16083773|NCT02280902|Biological|Blood samples|Systematic follow-up (M3, M6, M12, M18, M24, M30) will be implemented to complete epidemiologic, clinical, therapeutic and biological data during a 30 months period. Specific measure of immune cells, markers of immune activation, immunoglobulins as described above will be performed at M3, M6, M12 and M24. A biologic collection (serum and cells) will be performed at the same time points for future prognostic studies.
16083774|NCT02280876|Drug|1 - Andrographis paniculata p/st extract|"Andrographis paniculata Extract (ApE), Oral tablets 650 mg, with 170 mg. of andrographolides active principles, three times per day, during a total of 365 continuous days.
~Other Names:
~• ApE tablets, EUROMED Specific. Santiago Chile."
16083775|NCT02280876|Drug|2 - Excipients|"Placebo 650mg tabs, 2/day, 365 days continuously.
~Other Names:
~• Excipients tablets EUROMED Specific. Santiago Chile"
16083776|NCT02280863|Device|Medtronic Hybrid Closed-loop System - Android Platform|A continuous glucose sensor and insulin delivery system designed for continuous closed-loop control with the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm using an Android controller.
16083777|NCT02280863|Device|Medtronic Hybrid Closed-loop Integrated System|A fully integrated continuous glucose sensor and insulin delivery system designed for continuous closed-loop control with the PID-IFB (proportional-integral-derivative insulin feed-back) algorithm
16083778|NCT02280850|Drug|Guanxin Shutong Capsule|3 capsules three times a day; Duration: 4 weeks. Number of Cycles: until progression or unacceptable toxicity develops.
16083779|NCT02280850|Drug|Placebo Capsule|3 capsules three times a day; Duration: 4 weeks.
16083780|NCT02280850|Drug|nitroglycerine|"Adults: 0.25mg-0.5mg (half pill or 1 pill) once, sub-lingual. One more pill per 5 minutes untill pain relief. If total dose is 3 pills in 15 minutes and the pain is still in, please seek medical advice urgently.
~The participators in both arms who have agina symptom will take Nitroglycerine. So the accumulated consumption of participators is the one of the maesuremnts."
16083781|NCT02280837|Other|Determination of plasma GLP-1 level|Determination of GLP-1 level in samples of oral glucose tolerance tests
16083782|NCT02280824|Procedure|CA-TAVR|Transcaval acesss for transcatheter aortic valve replacement in patients with no good options for aortic access
16083783|NCT02280824|Device|Amplatzer Duct Occluder|
16083784|NCT02280811|Drug|Fludarabine|Patients will receive Fludarabine 25 mg/m^2/day for 5 days.
16083785|NCT02280811|Drug|Cyclophosphamide|Patients will receive Cyclophosphamide 60 mg/kg/day x 2 days
16083786|NCT02280811|Biological|E6 TCR|On day 0, cells will be infused intravenously (IV) over 20-30 minute (between 1 and 4 days after the last dose of fludarabine)
16083787|NCT02280811|Drug|Aldesleukin|Aldesleukin 720,000 IU/kg IV (based on total body weight) over 15 minutes approximately every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
16083788|NCT02280798|Procedure|Endometrial Biopsy|4 endometrial biopsy
16083789|NCT02280785|Drug|Brentuximab vedotin|Brentuximab vedotin must not be administered as an IV push or bolus. It must be administered in 100ml-250ml of 0.9% saline by intravenous infusion over 30 minutes once every 3 weeks.
16083790|NCT02280772|Dietary Supplement|Glucomannan|
16083791|NCT02280772|Dietary Supplement|Maltodextrin|
16083792|NCT02280759|Drug|Gelatin Tannate|
16083793|NCT02280759|Drug|Placebo|Placebo consists of an identical formulation, except active substance
16083794|NCT02280746|Other|Gluten challenge|Intervention will be continued for at least 6 months
16083795|NCT02280733|Other|Usual care|advanced dressings, off-loading, venous ulcer compression, arterial screening
16083796|NCT02280720|Procedure|Stenting using Optimax™|
16083797|NCT02280720|Procedure|Stenting using PROMUS Element™ Plus|
16083798|NCT02280707|Other|Grab a Cup, Fill it Up|The intervention involved installing promotional posters encouraging students to drink water as well as cup dispensers stocked with disposable 5 ounce cups near water fountains in school lunchrooms.
16083799|NCT02280694|Drug|Capecitabine|
16083800|NCT02280694|Drug|Cyclophosphamide|
16083801|NCT02280694|Drug|Methotrexate|
16083802|NCT02280694|Drug|Celecoxib|
16083803|NCT02280681|Other|No intervention, only questionnaire|No intervention, only questionnaire containing a discrete choice experiment identifying the importance of treatment aspects for deciding between current treatments and possible future treatments with artificial gametes
16083804|NCT02280668|Other|Icing Therapy|Participants will be randomly assigned into 3 experimental groups. Icing Protocol 1 has participants apply cold packs under the supervision of the principal investigators to their elbow flexor region for 10 minutes on, 10 minutes off, followed by an additional 10 minutes on, starting at time 0. Icing Protocol 2 follows the same procedure but it begins 6 hours after the participant has completed their eccentric muscle damaging exercise and is to be done at home without the supervision of the principal investigators. Both protocols require the participants to repeat their icing procedures every 24 hours until their involvement with the study is finished, which is 7 days in duration. The third experimental group is the control group and will not participate in an icing therapy during the duration of the study.
16083805|NCT02280668|Other|the eccentric muscle damage exercise|
16083806|NCT02280655|Biological|Storage-aged red blood cells (saRBCs) units|Packed RBCs units stored for greater than 21 days, with a mean storage duration of 29.6 ± 4.9 days (mean ± SD)
16083807|NCT02280655|Biological|Fresh red blood cells units|Packed RBCs units stored for less than 14 days, with a mean storage duration of 9.6 ± 3.9 days (mean ± SD)
16083808|NCT02280642|Biological|Both 2nd and 3rd doses on time|
16083809|NCT02280642|Biological|2nd dose late and 3rd dose on time|
16083810|NCT02280642|Biological|2nd dose on time and 3rd dose late|
16083811|NCT02280642|Biological|Both doses late|
16083812|NCT02280629|Drug|LT-02|LT-02 1.6g twice daily AND mesalamine PLACEBO three-times daily
16083813|NCT02280629|Drug|Placebo|LT-02 PLACEBO twice daily AND mesalamine PLACEBO three-times daily
16083814|NCT02280629|Drug|Mesalamine|LT-02 PLACEBO twice daily AND mesalamine 500mg three-times daily
16083815|NCT02280616|Drug|low dose budesonide tablet|1mg budesonide tablet twice daily AND 5ml placebo suspension twice daily
16083816|NCT02280616|Drug|high dose budesonide tablet|2mg budesonide tablet twice daily AND 5ml placebo suspension twice daily
16083817|NCT02280616|Drug|high dose budesonide suspension|placebo tablet twice daily AND 5ml [0.4mg budesonide/ml] suspension twice daily
16083818|NCT02280616|Drug|Placebo|placebo tablet twice daily AND 5ml placebo suspension twice daily
16083819|NCT02280603|Drug|DA-4001C|1ml by topical application twice a day
16083820|NCT02280603|Drug|5% minoxidil|1ml by topical application twice a day
16083821|NCT02280590|Drug|Rosuvastatin(Cresnon®)|10mg
16083822|NCT02280590|Drug|Rosuvastatin(Crestor®)|10mg
16083823|NCT02280564|Behavioral|health coaching with technology support|Intensive behavior change support. Engaging participants to take an active role in their diabetes care using motivational interviewing, technology, family communication, problem solving skills.
16083824|NCT02280538|Device|Intra-Articular Hyaluronic Acid|
16083825|NCT02280538|Device|Placebo|
16083826|NCT02280525|Drug|Lenalidomide|2.5 mg by mouth daily on Day -2 to Day +14.
16083827|NCT02280525|Drug|Rituximab|375 mg/m2 by vein on Day -5 for participants with B-cell cancer.
16083828|NCT02280525|Drug|Fludarabine|"Lymphodepleting Chemotherapy Option #1: Fludarabine 25 mg/m2 by vein on Days -5 to -3.
~Lymphodepleting Chemotherapy Option #2: Fludarabine 25 mg/m2 by vein over 1 hour on Day -6 to -2.
~Lymphodepleting Chemotherapy Option #3: Fludarabine 30 mg/m2 by vein over 1 hour on Days -6 to -2"
16083829|NCT02280525|Drug|Cyclophosphamide|"Lymphodepleting Chemotherapy Option #1: Cyclophosphamide 200 mg/m2 by vein on Days -5 to -3.
~Lymphodepleting Chemotherapy Option #2: Cyclophosphamide 60 mg/kg by vein over 3 hours on Days -5 and -4."
16083830|NCT02280525|Procedure|NK Cells|"Participant assigned to a dose level of NK cells based on when joined study. Starting dose level of NK cells 1 x 10^7 NK cells/kg given by vein on Day 0.
~NK Cell Infusion Expansion Phase: Maximum tolerated dose of NK cells from Induction Phase."
16083831|NCT02280525|Drug|Cytarabine|Cytarabine 2 mg/m2 by vein on Days -6 to -2.
16083832|NCT02280512|Device|elderly with fractures|hemodynamic monitoring with NICOM and tissue perfusion monitoring with NIRS
16083833|NCT02280499|Device|standard PROMOS prosthesis|
16083834|NCT02280486|Drug|Saxagliptin|5 mg/d
16083835|NCT02280486|Drug|Glimepiride|1mg/d, up titrated 1mg if FPG >6.1 mmol/L (110mg/dL) till 6 mg
16083836|NCT02280473|Drug|Refresh Optive® Gel Drops|Refresh Optive® Gel Drops; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
16083837|NCT02280473|Drug|REFRESH LIQUIGEL®|REFRESH LIQUIGEL®; 1-2 drops in each eye as needed at least 2 times daily for 30 days.
16083838|NCT02280447|Biological|1/3 IPV-Al SSI, manufactured by SSI, Denmark|Intramuscular injection of 0.5 mL vaccine into deltoid muscle
16083839|NCT02280447|Biological|1/5 IPV-Al SSI, manufactured by SSI, Denmark|Intramuscular injection of 0.5 mL vaccine into deltoid muscle
16083840|NCT02280447|Biological|1/10 IPV-Al SSI, manufactured by SSI, Denmark|Intramuscular injection of 0.5 mL vaccine into deltoid muscle
16083841|NCT02280447|Biological|IPV SSI, manufactured by SSI, Denmark|Intramuscular injection of 0.5 mL vaccine into deltoid muscle
16083842|NCT02280434|Drug|CBP-307|
16083843|NCT02280434|Drug|Placebo|
16083844|NCT02280421|Drug|ASP2151 400mg + 100mg ciclosporin|
16083845|NCT02280421|Drug|ASP2151 1200mg + 100mg ciclosporin|
16083846|NCT02280408|Other|Placebo|Normal saline placebo.
16083847|NCT02280408|Biological|V920|Vesicular Stomatitis Virus (VSV)-based vaccine 1-mL injection containing 3x10^6, 2x10^7, or 1x10^8 pfu.
16083848|NCT02280395|Drug|RUT058-60|Prior to closure of the abdomen at the end of the surgical repair, each subject will undergo lavage with approximately 900 mL of RUT058-60 administered as two 400 mL intra-abdominal (peritoneal) lavages and one 100 mL lavage above the fascia.
16083849|NCT02280395|Drug|Sterile saline for irrigation|Prior to closure of the abdomen, each subject will undergo lavage with approximately 900 mL of sterile saline administered as two 400 mL intra-abdominal (peritoneal) lavages and one 100 mL lavage above the fascia.
16083850|NCT02280382|Device|Femmeze®|Femmeze will be used by women in the intervention group for 8 weeks These women will be measuring against their usual care in a linear design; measurement will include validated questionnaires
16083851|NCT02280369|Device|Automated abdominal binder|Inflatable abdominal binder
16083852|NCT02280356|Radiation|external beam radiation therapy|
16083853|NCT02280356|Radiation|brachytherapy|
16083854|NCT02280356|Behavioral|questionnaires|
16083855|NCT02280343|Other|evaluated lung function|lung function tests
16083856|NCT02280330|Dietary Supplement|MNP group|MNP contains 15 vitamins an minerals, including Vitamin ADEC, B1, B2, B6, B12, Niacin, Folic Acid, Iron, Zine, Copper, Selenium and Iodine. There is 90 microgram of iodine per sachet of one gram of MNP.
16083857|NCT02280330|Other|Placebo group|The placebo is maltodextrin which is prepared as a white powder with similar physical characteristics and taste as MNP.
16083858|NCT02280317|Drug|VAL201|VAL201-001 Sub-cutaneous injection.
16083859|NCT02280304|Behavioral|Inner Resources for Veterans (IRV)|Mindfulness and breath-focused mantra therapy which uses techniques that encourage present moment attention for the purpose of improving self-monitoring and self-regulation
16083860|NCT02280304|Behavioral|Essential Skills therapy|This active comparator is adapted from a therapy utilized at multiple VAs as a psychoeducational AND symptom management treatment for PTSD. In it, participants learn about mTBI and PTSD symptoms and coping information for PTSD.
16083861|NCT02280291|Drug|Ankle SSB|general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc.
16083862|NCT02280291|Drug|Ankle OnQ|versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc.
16083863|NCT02280291|Drug|DR SSB|general anesthesia/sedationwith a single shot; general anesthesia/sedation with a single shot; Primary predictor variable: single shot block, a 22 gauge, 3.5 inch needle will be used and 20cc of 2% lidocaine with 1:200,000 epinephrine + 20cc of 0.5% bupivacaine with 1:300,000 epinephrine will be injected around the nerve after confirming negative aspiration every 5 cc.
16083864|NCT02280291|Drug|DR OnQ|versus regional block with continuous infusion using an OnQ pump. 17 gauge Tuohy needle will be used and 20cc of 2% lidocaine with epinephrine +20cc of 0.5% bupivacaine with1:300,000epinephrine will be injected around the nerve after confirming negative aspiration every 5cc.
16083865|NCT02280278|Procedure|Radical surgery|
16083866|NCT02280278|Drug|Adjuvant chemotherapy|
16083867|NCT02280278|Biological|Cytokine-induced killer cell immunotherapy|
16083868|NCT02280265|Drug|Recombinant Human Coagulation Factor VIII for injection|Subjects will initially be treated standard prophylaxis(20 - 40 IU/Kg body weight 2 times one week) with ADVATE for 1 year.
16083869|NCT02280252|Drug|Paclitaxel|Paclitaxel (including Abraxane), 30 mg/m2 twice per week. Paclitaxel will be given IV over 1 hour, Abraxane® will be administered over 30 min, and administered on a Monday/Thursday or Tuesday/Friday schedule.
16083870|NCT02280252|Radiation|Radiation therapy|Patients will receive a total dose of 45 Gy to the breast, axilla and supraclavicular area at 1.8 Gy/fraction, +14 Gy to the original palpable tumor at 2 Gy/fraction (total 32 fractions)
16083871|NCT02280239|Drug|Acetaminophen|one-time dose of acetaminophen 650mg given via the enteral route (via the gut)
16083872|NCT02280239|Drug|Placebo|one-time dose of placebo (identical capsule) given via the enteral route (via the gut)
16083873|NCT02280226|Device|magnetic resonance imaging (MRI)|
16083874|NCT02280213|Device|MIL|Direct laryngoscopy 1
16083875|NCT02280213|Device|MAC|Direct laryngoscopy 2
16083876|NCT02280213|Device|WIS|Direct laryngoscopy 3
16083877|NCT02280213|Device|PHIL|Direct laryngoscopy 4
16083878|NCT02280200|Device|AFO to improve outcomes|Ankle foot orthoses (AFO) are light-weight, low profile carbon fiber devices that store and release energy during ambulation. The AFO, in combination with standard of care advice to walk more, will be used to determine if there is any improvement in PAD patient outcomes.
16083879|NCT02280187|Procedure|Spine Fusion|All patients have been treated with a spinal fusion procedure with InductOs (rhBMP-2/ACS) following standard practice in each center.
16083880|NCT02280174|Drug|linagliptin|linagliptin 5 mg/d for12 weeks
16083881|NCT02280161|Other|cytology specimen collection procedure|Correlative studies
16083882|NCT02280148|Procedure|Endoscopy of Intravenous Anesthesia|The dose of intravenous anesthesia drug and time was controlled by the anesthesiologist,endoscopists were responsible for gastroscopy or colonoscopy , nurses assisted endoscopists with biopsy.Each subject's initial dose of propofol were set at 2mg / kg, and were added properly by anesthesiologists additional according to the subjects' intraoperative sedation or surgical time.
16083883|NCT02280148|Device|Driving Simulator|
16083884|NCT02280148|Drug|Propofol|2mg / kg
16083885|NCT02280135|Biological|Intravitreal injection of Autologous bone marrow Stem Cell|"We will proceed to the injection of 0.1 ml of the suspension with the autologous MNC of BM avoiding coincide with conjunctival and scleral hole and perpendicular to the sclera.
~After the injection, a dry, sterile dressing will be placed to prevent reflux. Immediately, the perception of light, the movement of the central retinal artery, the venous pulse and the color of the papilla will be evaluated. If necessary, anterior chamber paracentesis will be performed.
~After injection, the patient will remain with closed eyes and sitting, waiting for cells will be deposited on the bottom of the eyeball and for 3 days will instill tropicamide collyrium every 12 hours."
16083886|NCT02280135|Other|Subconjunctival injection of saline|"In the control eye, will make a subconjunctival injection of 0.1 ml saline. To realize contralateral injection gloves and all surgical materials will change, trying extreme measures of sterility.
~After injection, the patient will remain with closed eyes and sitting, waiting for cells will be deposited on the bottom of the eyeball and for 3 days will instill tropicamide collyrium every 12 hours."
16083887|NCT02280122|Other|no intervention provided|No Intervention was rendered but the aMMP-8 test was made
16083888|NCT02280109|Drug|Tenofovir Gel|single dose of 1% tenofovir gel (equivalent to 40 mg in 4ml's of gel)
16083889|NCT02280109|Drug|Tenofovir Film|single dose of 1.3% tenofovir film (equivalent to 40 mg)
16083890|NCT02280096|Drug|4-aminopyridine|Each patient will take two capsules every 8 hours after meals, for a total of 6 capsules/day. The 4-aminopyridine dosage will increase 10 mg/4 weeks by substitution of placebo instead of 4-aminopyridine capsules; such that patients will receive from 40 to 60 mg. distribute in 6capsules/day throughout the study.
16083891|NCT02280096|Drug|Placebo|The placebo arm will include Microcrystalline Cellulose placebo
16083892|NCT02280083|Drug|Botulinum Toxin Type A for Injection|"HengLi002(Botulinum Toxin Type A for Injection,also known as HengLi®)"
16083893|NCT02280083|Drug|placebo|placebo
16083894|NCT02280070|Other|Laboratory test|Leukocyte, neutrophil (ANC ：stab + seg), hemoglobin, platlet, albumin, total birrilubin, AST, ALT, LDH, Creatinine, Na, K, CRP, fast blood sugar
16083895|NCT02280070|Other|Medical history and physical examination|medical history and physical examination
16083896|NCT02280070|Other|BW and height|Body weight (kg) and height (cm)
16083897|NCT02280070|Other|Performance status|ECOG performance status, 0: Fully active, able to carry on all pre-disease performance without restriction, 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work, 2: Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours, 3: Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours, 4: Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair, 5: Dead
16083898|NCT02280070|Other|Creatinine clearance|Creatinine clearance (CCr, mL/min) was estimated by Cockcroft & Gault method using serum creatinine (mg/dL), age and body weight (kg).
16083899|NCT02280070|Other|Biomarker|Carcinoembryonic antigen and carbohydrate antigen 19-9
16083900|NCT02280070|Radiation|Contrasting CT|Computed tomography
16083901|NCT02280070|Other|Adverse event|AE was evaluated using Common Terminology Criteria for Adverse Events (CTCAE v4.0).
16083902|NCT02280070|Other|HBs antigen and HCV antibody|check for exclusion criteria
16083903|NCT02280070|Other|Endoscopy|Endoscopy for lower digestive tract
16083904|NCT02280070|Other|HBs antibody and HBc antibody|Check according to hepatitis B guideline
16083905|NCT02280070|Drug|S-1|S-1 (80 mg/m2, p.o.) is administered at day 1 -14 of the course and repeated every 3 weeks until 4 courses or meet discontinuation criteria.
16083906|NCT02280070|Drug|L-OHP (130mg/m2)|L-OHP (130mg/m2 intravenously) is administered at day 1 of the course and repeated every 3 weeks until 4 courses or meet discontinuation criteria.
16083907|NCT02280070|Drug|L-OHP (85 mg/m2)|L-OHP (85mg/m2) is administered by IV infusion drip for 2hr at day 1 of the course and repeated every 2 weeks until 6 courses or meet discontinuation criteria.
16083908|NCT02280070|Drug|l-LV|l-LV (200 mg/m2) is administered by IV infusion drip for 2hr at day 1 of the course and repeated every 2 weeks until 6 courses or meet discontinuation criteria.
16083909|NCT02280070|Drug|5-FU|5-FU (400 mg/m2) by bolus IV administration just after the L-OHP and l-LV administration. 5-FU (2,400 mg/m2) by IV continuous infusion for 46 hours using infuser pump afterwards and repeated every 2 weeks until 6 courses or meet discontinuation criteria.
16083910|NCT02280057|Drug|Metformin|Metformin 1500 mg (=2 pills) per day in six months
16083911|NCT02280057|Drug|Placebo|2 pills per day in six months; pills look like metformin pills
16083912|NCT02280044|Biological|Rifaximin intervention|Rifaximin administered then Challenge with C jejuni
16083913|NCT02280044|Biological|Placebo intervention|Placebo administered then Challenge with C jejuni
16083914|NCT02280031|Drug|Acetylsalicylic Acid|Capsule containing Acetylsalicylic Acid 80mg pill with lactose
16083915|NCT02280031|Drug|Placebo|Capsule containing placebo pill with lactose
16083916|NCT02280018|Drug|JNJ-49122944, 5 milligram (mg)|Participants will receive single dose of 5 mg JNJ-49122944, administered as a 22.2 mL IV infusion over 45 minutes on Day 1.
16083967|NCT02279667|Drug|BIA 2-093|200 mg tablet
16083968|NCT02279667|Drug|BIA 2-093|800 mg tablet
16083917|NCT02280018|Drug|Placebo|Participants will receive placebo matched to JNJ-49122944, administered as a 22.2 mL IV infusion over 45 minutes on Day 1.
16083918|NCT02280005|Device|WAK Treatment|Hemodialysis with WAK device.
16083919|NCT02279992|Drug|Vardenafil|
16083920|NCT02279992|Drug|Carboplatin|
16083921|NCT02279979|Device|HeartMate PHP|The HeartMate PHP system is a catheter-based heart pump and console designed to provide hemodynamic left ventricular support for up to 3 days to stabilize patients by maintaining adequate systemic cardiac output.
16083922|NCT02279966|Drug|Vortioxetine 10 mg|
16083923|NCT02279966|Drug|Paroxetine 20 mg|
16083924|NCT02279966|Drug|Placebo|
16083925|NCT02279953|Drug|Vortioxetine 10-20 mg|
16083926|NCT02279953|Drug|Placebo|
16083927|NCT02279953|Drug|SSRI|escitalopram, citalopram or sertraline
16083928|NCT02279927|Device|Ureteroscopy|Ureteroscopy with laser stone fragmentation
16083929|NCT02279914|Drug|Misoprostol 400 mcg 3 hours prior to procedure|Misoprostol 400 mcg 3 hours prior to D&E procedure
16083930|NCT02279914|Drug|Misoprostol 600 mcg 90 minutes prior to procedure|Misoprostol 600 mcg 90 minutes prior to D&E procedure
16083931|NCT02279901|Behavioral|Telemedicine Education|"Emmi Solutions produces Web-based, simple to understand, healthcare related educational programs. These programs are interactive sessions that last about 15 minutes, educating patients on the risk of OSA and assisting in preparing patients for procedures. Two such programs will be sent to patients at preset intervals over the duration of the study:
~OSA program
~CPAP program
~Links to each of these programs are emailed to the patient and date of birth needs to be verified before the program will start. The programs ask the patient for feedback at regular intervals and provide opportunities throughout to make notes or write down questions that can be later printed. These programs are already approved for clinical use within Kaiser Permanente which has a contract with the vendor."
16083932|NCT02279901|Behavioral|IVR|"Interactive Voice Response (IVR) is a protocol in which automated messages are delivered via e-mail, text or phone to patients to provide feedback regarding their CPAP use, intended to improve therapy adherence. The basic protocol involves the use of CPAP devices that wirelessly send usage data to a cloud platform. Automated algorithms will assess the usage data and send messages to the patient when there is suboptimal usage or excessive leak, or to provide encouragement for successful use.
~Specifically, we will use CPAP devices with built-in modems which will send usage data via cellular network to cloud-based platforms that will automatically analyze the usage data and send the automated messages. Patients also can track their own therapy information through the platform."
16083933|NCT02279888|Device|CardioMEMS HF System|Pulmonary artery pressure sensor
16083934|NCT02279875|Drug|Linezolid|
16083935|NCT02279875|Drug|HRZE (isoniazid rifampicin,pyrazinamide,ethambutol)|isoniazid (H) 75 mg plus rifampicin (R) 150 mg plus pyrazinamide (Z) 400 mg plus ethambutol (E) 275 mg
16083936|NCT02279862|Drug|Ipilimumab|
16083937|NCT02279849|Other|Communications|Communication materials were used to promote healthier items to consumers in corner stores.
16083938|NCT02279849|Other|Pricing|The pricing incentives were used to help promote sales of healthier food items.
16083939|NCT02279849|Other|Combined (Communications & Pricing)|Communications with Pricing incentives were used to promote the sale/consumption of healthier foods.
16083940|NCT02279836|Device|SC20 Colonoscope|Single Arm Post-Marketing Study of SC20 Colonoscope
16083941|NCT02279823|Drug|CB-03-01 solution|Investigational drug solution
16083942|NCT02279823|Drug|Minoxidil Solution 5%|FDA approved marketed product
16083943|NCT02279823|Drug|Placebo solution|Vehicle solution
16083944|NCT02279810|Behavioral|survey|Survey
16083945|NCT02279797|Behavioral|survey|Survey about Knowledge, Attitude and Practice About bone marrow donation
16083946|NCT02279784|Device|Freeway PTA|angioplasty with Freeway drug-eluting balloon
16083947|NCT02279784|Device|Lutonix PTA|angioplasty with Lutonix drug-eluting balloon
16083948|NCT02279771|Procedure|transanal anastomotic reinforcement|"a circular anal dilator (CAD) of 34mm in diameter will be introduced into the anus to facilitate the transanal introduction of the 29-31 circular stapler. The stapler shaft will be introduced trying to avoid the stapler line and connected with the anvil of the prepared proximal colon and then fired.
~Patients selected on the TAR-LAR arm will have the stapled suture reinforced by 6 supplemental full thickness stitches in vycril 3/0 placed transanally with the aid of a semicircular valve introduced into the CAD (Epo Flier, SapiMed SPA, Alessandria, Italy), at hours 2-4-6-8-10-12."
16083949|NCT02279771|Procedure|protective ileostomy group|S-LAR patients will had a standard lateral protective ileostomy in the right iliac region or a colostomy in the left region.
16083950|NCT02279771|Device|a circular anal dilator (CAD)|Epo Flier, SapiMed SPA, Alessandria, Italy
16083951|NCT02279758|Drug|Metformin|
16083952|NCT02279745|Drug|Ralinepag|Active
16083953|NCT02279732|Biological|Paclitaxel|
16083954|NCT02279732|Biological|Carboplatin|
16083955|NCT02279732|Biological|Ipilimumab|
16083956|NCT02279732|Other|Placebo|0.9% sodium chloride injection, USP, or 5% dextrose injection
16083957|NCT02279719|Drug|BBI608|BBI608 will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study.
16083958|NCT02279719|Drug|BBI503|BBI503 will be administered in combination with sorafenib at the RP2D determined during the phase 1 dose-escalation portion of study.
16083959|NCT02279719|Drug|Sorafenib|Sorafenib will be administered at a fixed dose of 400 mg twice daily (800 mg total daily dose). Sorafenib should be taken on an empty stomach, one hour prior to or two hours after meals. Sorafenib should not be taken with study drug, and at least 2 hours should separate a dose of sorafenib from a dose of study drug.
16083960|NCT02279706|Other|questionnaire|Check the Korean version of rhinitis controlled assessment tests, the total non-symptom scores (total nasal symptoms score, TNSS), rhinitis-related quality of life (RQLQ), rhinitis controlled degree, severity, and after study enrollment and 4 weeks treatment.
16083961|NCT02279693|Other|CBCT|10 participants will receive a cone beam computed tomography (CBCT) repositioning
16083962|NCT02279693|Other|fiducial marker (kV imaging)|10 participants will receive a kV imaging of fiducial marker repositioning.
16083963|NCT02279693|Radiation|IGRT Associated With IMRT|
16083964|NCT02279680|Device|Electroencephalography|
16083969|NCT02279654|Drug|Lenalidomide|Lenalidomide as prescribed in routine clinical practice for low to intermediate-1 risk MDS
16083970|NCT02279641|Drug|RDEA3170 10 mg|
16083971|NCT02279641|Drug|allopurinol 300 mg|
16083972|NCT02279628|Drug|Ropivacaine|Ropivicaine (0.2%) bolus of 10ml will be injected through the catheter after surgery and continuously infused during the postoperative period (8ml/H)
16083973|NCT02279628|Drug|Morphine|Morphine will be injected intrathecally (100µg) and oral morphine will be given during the postoperative period
16083974|NCT02279615|Drug|Mirabegron|50mg of mirabegron per day will be given.
16083975|NCT02279615|Drug|Tamsulosin|0.4mg of flomax per day.
16083976|NCT02279602|Drug|fosbretabulin|fosbretabullin, 60 mg/m2 weekly for up to 1 year
16083977|NCT02279589|Biological|Pneumo 23® 0,5|Polysaccharide vaccine Pneumo 23® (Sanofi Pasteur MSD), containing 23 valencies Pneumococcus (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F) administered by intramuscular route. (Deltoid) at full dose. One dose contains: 0, 5 mL of 25 μg of polysaccharide of the 23 serotypes pneumococcus.
16083978|NCT02279589|Biological|Pneumo 23® 0,1|Polysaccharide vaccine Pneumo 23® (Sanofi Pasteur MSD), containing 23 valencies Pneumococcus (1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, 33F) administered by intramuscular route. (Deltoid) at a 1/5 of the dose. One dose contains: 0, 5 mL of 25 μg of polysaccharide of the 23 serotypes pneumococcus.
16083979|NCT02279589|Biological|Prevenar13® 0,5|"The conjugate vaccine Prevenar13® (Pfizer) containing 13 valencies Pneumoccocus (4, 6B, 9V, 14, 18C, 19F, 23F), conjugated with diphtheria anatoxin (CRM 197) administered by intramuscular route (deltoid).
~One dose contains: 0, 5 ml of 2 - 4μg of polysaccharide of the13 serotypes pneumococcus which 12 are shared with Pneumo 23® vaccine conjugated to diphtheria toxoid (CRM 197)."
16083980|NCT02279576|Drug|Pazopanib|Pazopanib 800mg/day continuously administered.
16083981|NCT02279576|Drug|Paclitaxel|Paclitaxel 65 mg/m2 in weekly administration 3 administrations (D1, D8 and D15) every 4 weeks period.
16083982|NCT02279563|Drug|Azelastine HCl and Fluticasone Propionate Nasal Spray, 137 µg/50 µg per spray|"During the placebo lead-in period, the placebo nasal spray was administered via nasal inhalation with one spray in each nostril twice daily for 7days.
~During the randomized treatment period, the investigational products (experimental, active comparator and placebo nasal spray) were administered via nasal inhalation with one spray in each nostril twice daily for 14 days"
16083983|NCT02279563|Drug|Dymista™ Nasal Spray|
16083984|NCT02279563|Drug|Placebo|
16083985|NCT02279537|Drug|Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)|Administration by intravitreal injection
16083986|NCT02279524|Drug|Aramchol|"Subjects will be administered Aramchol as follows:
~One tablet of Aramchol 400 mg and one tablet of matching placebo for Aramchol.
~One tablet of Aramchol 400 mg and one tablet of Aramchol 200 mg.
~Two tablet of Aramchol matching placebo. The tablets should be taken orally in the morning within 30 min after breakfast with a glass of water (250 ml).
~Subjects are allowed to omit study drugs up to 3 consecutive days during the study."
16083987|NCT02279511|Drug|ADENOSINE TRIPHOSPHATE|Infusion of 2.5g of ATP in 500 mL of saline solution. (IV)
16083988|NCT02279511|Drug|PLACEBO|Infusion of 500 mL of saline solution. (IV)
16083989|NCT02279498|Drug|Liprotamase|oral, soluble, non-enterically coated, non-porcine, pancreatic enzyme replacement
16083990|NCT02279498|Drug|porcine (pig) PERT|oral, enterically-coated, pancreatic replacement enzymes prepared from a porcine source
16083991|NCT02279485|Drug|Perampanel|
16083992|NCT02279472|Procedure|Laserex Tango Nd:YAG, Ellex-SuperQ Medical, Australia|All the patients will be achieved with pilocarpine 1% for pupil constriction, laser peripheral iridotomy(LPI) is performed using the ophthalmic neodymium: yttrium aluminium garnet laser (Laserex Tango Nd:YAG, Ellex-SuperQ Medical, Australia) and an VOLK iridotomy contact lens. After LPI, patients will be given topical prednisolone acetate 0.1% for 7 days.
16083993|NCT02279446|Other|Intermediate Visual acuity (IVA) assessment|Intermediate visual acuity (IVA) will be assessed with the Intermediate Visual acuity chart which is similar to the prevalent Jaeger chart. It consists of short blocks of text in various type sizes.The computer screen is set at a specific reading distance (1 meter) and the patient is asked to read the passage with the smallest type he/she can see. According to the smallest text he/she can read, IVA is classified from IVA1 (which is considered the equivalent of 20/20 distance visual acuity) to IVA5
16083994|NCT02279433|Drug|DS6051b|DS-6051b 50 mg and 200 mg capsules for oral administration
16083995|NCT02279420|Device|g-Cath EZ™ Suture Anchor Delivery Catheter|This is a multicenter, un-blinded, open label, pivotal supplemental study to G130163 intended to evaluate the safety and efficacy of treating previous sham subjects in the Essential pivotal trial (IDE#G130163) with the active treatment (the placement of g-Cath EZ suture anchors along with diet and exercise). Compliant sham subjects (those who attended all primary IDE follow-up visits AND who continue to meet eligibility criteria as described in this protocol) will be offered this active treatment after their 12 month unblinding visit in the Essential pivotal trial.
16083996|NCT02279407|Drug|placebo|Placebo matching to Omega-3 carboxylic acids (olive oil)
16083997|NCT02279407|Drug|Omega-3 carboxylic acids|4 g administered as 4 x 1 g capsules
16083998|NCT02279407|Drug|Dapagliflozin|10 mg administered as 10 mg tablet
16083999|NCT02279407|Drug|Placebo|Placebo matching to dapagliflozin 10 mg
16084000|NCT02279394|Drug|Elotuzumab|10 mg/kg IV; Days 1, 8,15, 22 Cycles 1-2 10 mg/kg IV; Days 1 & 15 Cycles 3-8
16084001|NCT02279394|Drug|Lenalidomide|25 mg Oral; Days 1-21 days Cycles 1-24
16084002|NCT02279394|Drug|Dexamethasone|40 mg Oral; Days 1, 8, 15, 22 Cycles 1-2 40 mg Oral; Days 1, 8, 15 Cycles 3-8
16084003|NCT02279381|Drug|Chlorhexidine|4% chlorhexidine will be applied to the umbilical stump from day 1 to day 10
16084004|NCT02279381|Other|Kangaroo Mother Care|Skin to Skin Care which is Kangaroo mother care will be carried out by mother from Day 1 till the study completion
16084005|NCT02279381|Other|Essential Neonatal Care|Essential Neonatal Care ensures delayed bathing, use of colostrum, exclusive breast feeding, skin to skin care for hypothermia, dry cord care, eye care and immunization for the newborn
16084006|NCT02279368|Behavioral|Family Counselling and safeguarding|
16084007|NCT02279342|Drug|Febuxostat|The starting dose of the febuxostat will be 10mg /day. The dose will be increased to 20 mg/day at week 4 and finally titrated to 40 mg/day at week 8.
16084008|NCT02279329|Other|Hyperpolarized Helium MRI|Hyperpolarized helium-3 (3He) magnetic resonance imaging (MRI) has recently emerged as another research approach for the non-invasive measurement of lung structure and function, including conduction of gas through airways and into airspaces. Preliminary studies suggest that 3He MRI may be ideally suited for longitudinal COPD research, which is a likely target application of this novel technology. 3He MRI provides a complementary and alternative method for evaluating COPD and may be superior to CT because it allows simultaneous visualization of both airway and airspace structure and function.
16084009|NCT02279316|Drug|Vi-De 3|All participants receive a dose of 800 IU vitamin D3 per day as a standard of care. 800 IU Vitamin D is the dose that is currently recommended by the Swiss Health Department (Bundesamt für Gesundheit) for seniors over 60.
16084010|NCT02279316|Other|Jaques-Dalcroze eurhythmics|The Jaques-Dalcroze eurhythmics method includes different courses of motion (multi-task exercises) that are conducted to the rhythm of improvised piano music. A session starts with a short warm-up that includes simple exercises to get body and mind prepared for the rest of the exercise session. The complexity of the exercises increases gradually during the session: starting with single tasks and then combining them into a multi-task exercise gradually increasing complexity.
16084011|NCT02279316|Other|Home exercise program|The home exercise program is a strengthening program that will consist of five simple exercises.
16084012|NCT02279303|Behavioral|Dietary Intervention|Participants will receive individualized anti-inflammatory dietary prescriptions with six monthly workshops (culinary demonstrations, recipes and meal planning) and behavior change cures reinforced through evidence- and theory-based patient navigation, motivational interviewing, and tailored newsletters personalized to individual readiness for change.
16084013|NCT02279303|Behavioral|Dietary Control|Control participants will receive minimal nutritional information at baseline, monthly American Cancer Society survivorship brochures, and two telephone calls prior to assessment appointments.
16084014|NCT02279290|Behavioral|Healthy Mind Intervention (HMI)|Healthy Mind Intervention (HMI) is a flexible cognitive-behavioral resilience building program. Participants will receive 8 weekly, 60-minute individual sessions of HMI. In HMI, participants will be able to select 3 areas of resilience that they want to work on.
16084015|NCT02279290|Behavioral|Healthy Body Intervention (HBI)|The 8 weekly, 60-minute individual sessions will include the following topics: the mind-body connection, nutrition, exercise, unhealthy substances, sleep, preventing illness, and preventive care. Each session is spent providing didactic information on these topics and strategies for how to engage in behavior change in these areas.
16084016|NCT02279277|Behavioral|Supervised physical therapy program prior to total knee replacement surgery|
16084017|NCT02279264|Device|RightSpot Infant pH Indicator|pH indicator
16084018|NCT02279251|Behavioral|VÅG|Low-intensity CBT intervention
16084019|NCT02279251|Behavioral|CHILLED|Standard length CBT intervention
16084020|NCT02279238|Procedure|cardiac rehabilitation|"It is a cross over study in which the participants are assigned for two test simultaneously with washout time of 6 hrs . 5th POD patients are randomly assigned to either 6 minute walk test or 3 minute ramp walk test as first test with 6 hours of rest [Washout time] in between the two test.
~6 MWT : The patient is instructed to walk for a period of 6 minute on a 30 meters Hallway with its extent being demarcated by the placement of 2 cones at the extremes of the Hall.
~3 MRWT : The patient is instructed to walk for a period of 3 minute on a Ramp with an elevation of 30 degree and length of 20 meters with its extent being demarcated by the placement of 2 cones at the extremes of the ramp.
~The data of [HR, SPO2, PSG RPE scale, Distance walked, BP] the participants are collected before, during and after the completion of each lap [according to American Thoracic Society [ATS] protocol]."
16084021|NCT02279225|Radiation|Group Phototherapy|
16084022|NCT02279225|Radiation|Phototherapy + Physical activity|
16084023|NCT02279225|Other|Physical activity|
16084024|NCT02279225|Other|Placebo|
16084025|NCT02279186|Drug|Tranexamic Acid|Intravenous Injection
16084026|NCT02279173|Drug|Romiplostim|Romiplostim subcutaneous weekly injection
16084027|NCT02279160|Drug|APD811|
16084028|NCT02279160|Drug|Placebo|Placebo
16084029|NCT02279147|Drug|neostigmine methylsulfate，raceanisodamine hydrochloride|The patients receive immediately raceanisodamine hydrochloride(10mg) by intramuscular injection after operation .From that date, for three consecutive days, the patients will be receive 50mg raceanisodamine hydrochloride and 0.15mg neostigmine methylsulfate in the 24h by slow injection of vein.
16084030|NCT02279134|Radiation|Adjuvant Chemoradiation|Patients receive Paclitaxel 135-150mg/m2 (D1 and D29) and Cisplatin or Nedaplatin 50-75mg/m2 (D1 and D29) every 4 weeks, concurrent with radiotherapy. Prophylactic polyethylene glycol recombinant human G-CSF is administered 48 hours after chemotherapy. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.
16084031|NCT02279134|Radiation|Adjuvant Radiation|Patients undergo radiotherapy once daily 5 days a week for an average of 5.5 weeks within 12 weeks after surgery in the absence of disease progression or unacceptable toxicity.
16084032|NCT02279134|Drug|Paclitaxel|135-150mg/m2 (D1 and D29)
16084033|NCT02279134|Drug|Cisplatin or Nedaplatin|50-75mg/m2 (D1 and D29)
16084034|NCT02279121|Device|Taurolock|At the beginning of each course of IV anti-tumor treatment, a nurse removes the lock TauroLock ™ and makes rinsing the CVC. At the end of each course, she rinses again the CVC and instills TauroLock ™ solution. Patients will be followed for each treatment, according to the same rhythm of their anti-tumor treatment program up to the end of the study
16084035|NCT02279121|Drug|saline solution|At the beginning of each course of IV anti-tumor treatment, a nurse makes rinsing the CVC. At the end of each course, she rinses again the CVC. Patients will be followed for each treatment, according to the same rhythm of their anti-tumor treatment program up to the end of the study
16084036|NCT02279108|Drug|indocyanine green|One injection, 2.5 milligrams per patient, intradermal use
16084037|NCT02279108|Drug|isotope|One injection, 20 MBq techntium99, intradermal use
16084038|NCT02279095|Drug|Palovarotene dose level 1|Palovarotene was taken orally once daily at approximately the same time each day.
16084039|NCT02279095|Drug|Palovarotene dose level 2|Palovarotene will be taken orally once daily at approximately the same time each day.
16084040|NCT02279095|Drug|Palovarotene dose level 3|Palovarotene will be taken orally once daily at approximately the same time each day.
16084108|NCT02278562|Other|placebo|placebo capsules and injection
16084041|NCT02279095|Drug|Palovarotene dose level 4|Palovarotene will be taken orally once daily at approximately the same time each day.
16084042|NCT02279082|Drug|DFN-02|Active Experimental Drug
16084043|NCT02279069|Device|4-roll canne|
16084044|NCT02279056|Behavioral|Self-help book for insomnia|RCT comparing efficacy of a self-help book for insomnia and sleep hygiene advice in patients with co-morbid OSA and insomnia.
16084045|NCT02279056|Behavioral|Sleep hygiene advice|RCT comparing efficacy of a self-help book for insomnia and sleep hygiene advice in patients with co-morbid OSA and insomnia.
16084046|NCT02279043|Behavioral|Interaction with users of IUC and non-IUC users|"Birth Control Connect is an online community where women will be invited to share their personal experiences with birth control. Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group (e.g. If you're using a birth control method right now, how did you choose it?). Participants will also be able to pose questions to other members of the group and respond to other members' questions. Half of participants in Birth Control Connect intervention groups will be current IUC users."
16084047|NCT02279043|Behavioral|Interaction with non-IUC users only|"Birth Control Connect is an online community where women will be invited to share their personal experiences with birth control. Birth Control Connect group sessions will last for twelve days. Each day, participants will be prompted to respond to questions in the group (e.g. If you're using a birth control method right now, how did you choose it?). Participants will also be able to pose questions to other members of the group and respond to other members' questions."
16084048|NCT02279030|Other|MIBG nuclear scan|To have scan to help define pathways for PVC ablations.
16084049|NCT02279017|Behavioral|mHealth Texting for Weight Loss|
16084050|NCT02278991|Device|Lutonix Drug Coated Balloon|Subject will receive treatment with the Lutonix Drug Coated Balloon
16084051|NCT02278978|Drug|BIBF1120|BIBF1120 200 mg two times per day orally
16084052|NCT02278965|Drug|Metformin|Metformin 850mg, oral, twice a day for 12 months
16084053|NCT02278965|Drug|Omega-3 fatty acids|Omega-3 fatty acids 2 capsules (560 mg each) oral, twice a day for 12 months
16084054|NCT02278939|Behavioral|Filipinos Fit and Trim Weight Loss Program|This 3-month pilot RCT with wait-list control Fit and Trim lifestyle intervention is designed to reduce weight by increasing physical activity, and health eating to improve fasting glucose and hemoglobin A1c. This intervention will use a mobile phone health app diary to self-monitor weight, physical activity, and diet to improve health outcomes to reduce type 2 diabetes risks in Filipino Americans. Program goals are to lose 5% body weight, increase and maintain steps to 12,000 steps/day (20% increase in step-counts each week), reduce total daily fat intake (25% of total calories from fat), and sugar-sweetened beverages over 3 months.
16084055|NCT02278926|Other|Ultrasound|Ultrasound measurements
16084056|NCT02278926|Other|Tapping and body inspection to define the area of insulin injection|Obese patients with a thickening fat subcutaneous tissue that could have interfered with the interpreting and analyzing of the data are left out of this first study. In the control group we manage to define the lypo-hypertrophic area by tapping and body inspection
16084057|NCT02278913|Drug|Basal Bolus (Glargine and Glulisine)|Glargine daily + Glulisine before meals
16084058|NCT02278913|Drug|Human Insulin|NPH twice a day + Regular insulin before meals
16084059|NCT02278900|Other|Communication aids|Question Prompt list Audiofile
16084060|NCT02278887|Procedure|Translational research|Before during and at progression/regression biopsies and blood will be taken for translational research
16084061|NCT02278887|Drug|Cyclophosphamide|The patient receives 2 days cyclophosphamide via IV to deplete T-cells.
16084062|NCT02278887|Drug|Fludarabine|The patient receives 5 days fludarabine via IV to deplete T-cells.
16084063|NCT02278887|Drug|Interleukin-2|After infusion of the TIL, the patient receives IL-2 to keep the TIL active.
16084064|NCT02278887|Drug|Ipilimumab infusion|In arm A patients will be treated with 4 infusion of ipilimumab
16084065|NCT02278861|Drug|Oral isotretinoin|Oral isotretinoin - 10mg/day (one pill) after lunch for six months
16084066|NCT02278861|Drug|Tretinoin 0,05% cream|Topical tretinoin 0,05% cream - applied every other night in the face and forearms for six months
16084067|NCT02278861|Drug|Sunscreen FPS 60|Sunscreen FPS 60 applied on sun exposed areas every 3 hours daily
16084068|NCT02278848|Other|Diagnosis of ICAH using new investigative techniques (computerised gait analysis, ultrasound, MRI flow, urinary incontinence scale)|Diagnosis of ICAH using new investigative techniques (computerised gait analysis, ultrasound, MRI flow, urinary incontinence scale)
16084069|NCT02278835|Other|breathing exercises|3 sets of 10 repetitions of deep breathing exercises
16084070|NCT02278835|Device|incentive spirometry|3 sets of 10 repetitions of deep breathing exercises with incentive spirometry
16084071|NCT02278835|Device|Intermittent positive pressure breathing|20 minutes breathing with intermittent positive pressure
16084072|NCT02278835|Device|Continuous positive airway pressure|20 minutes breathing with continuous positive airway pressure
16084073|NCT02278822|Other|Low dose oral liposomal glutathione supplementation|Low dose oral liposomal glutathione supplementation
16084074|NCT02278822|Other|High dose oral liposomal glutathione supplementation|High dose oral liposomal glutathione supplementation
16084075|NCT02278809|Behavioral|Movie Models|"The intervention group got acces to a private website for 4 weeks on which the online videos were placed (Week 1: fruit + water, week 2: vegetables + breakfast + supermarket, week 3: PA, week 4: SB)
~After each week, parents received a link for an online process evaluation questionnaire in which we asked how many times they watched each video, if they discussed the videos with other people, if they found them interesting, boring…"
16084076|NCT02278796|Drug|BeEAM|Chemotherapy regimen consisting of bendamustine intravenously on days -7 and -6 at 200 mg/m2; cytarabine, 400 mg/m2 intravenously daily from day -5 to day-2; etoposide, 200 mg/m2 intravenously daily from day -5 to day -2; and melphalan, 140 mg/m2 intravenously on day -1 before reinfusion of autologous stem cells
16084077|NCT02278796|Drug|BEAM|Chemotherapy regimen with carmustine (BCNU) 300 mg/m2 on day -6, cytarabine, 400 mg/m2 intravenously daily from day -5 to day-2; etoposide, 200 mg/m2 intravenously daily from day -5 to day -2; and melphalan, 140 mg/m2 intravenously on day -1 before reinfusion of autologous stem cells
16084109|NCT02278523|Device|Threshold IMT®|A device used to offer threshold load to inspiratory muscle
16085458|NCT02268773|Drug|Acetylsalicylic acid high dose|
16084078|NCT02278783|Drug|regorafenib|Patients will be treated with Regorafenib 160 mg (4 x 40 mg tablets) daily for 21 days of a 28 day cycle (three weeks on drug, one week off) until disease progression or adverse effects prohibit further treatment
16084079|NCT02278757|Other|High protein diet|Group received a diet with higher protein content (1.34gr/kg body weight). Meal replacements (drinks and bars) and individualized menus, controlling the content of calories, protein, carbohydrates, and fat, had more control over the total amount of protein consumed daily. Participants consumed two, protein-enriched drinks, contributing to the daily protein intake along with conventional foods and two low-fat bars. For both groups (intervention and control), the calorie density had a restriction of 500kcal/day calories less than the resting metabolic rate (RMR) and were equivalent in the type of carbohydrate. Recommendations for exercise (e.g., walking, biking or jogging at least 30 minutes/day, 5 days per week).
16084080|NCT02278757|Other|Low protein diet|Control group received a diet with a lower protein content (0.8gr/kg body weight). Conventional foods (such as fish, meet, vegetables, fruits, nutrs, beans, etc) were prescribed. Individualized menus, controlling the content of calories, protein, carbohydrates, and fat, had more control over the total amount of protein consumed daily. The calorie density had a restriction of 500kcal/day. Recommendations for exercise (e.g., walking, biking or jogging at least 30 minutes/day, 5 days per week)
16084081|NCT02278744|Radiation|single-fraction radiation|Patients enrolled on this study will be registered into a dose tier and undergo 1 session of image-guided SRS using techniques previously. Three escalating SRS spinal cord/cauda maximum dose (Dmax) levels (14 Gy, 16 Gy, and 17 Gy) will be evaluated to determine the safety of this approach. A minimum of three patients will be treated per dose tier. Toxicity based on NCI CTCAE (v4). Post treatment followup at 2 and 4 months (+/- 2 weeks) post-treatment, at 6 months (+/- 4 weeks) and then every 3 months until 2 years (± 4 weeks). Followup schedule based on last day of treatment. No schedule adjustments based on early or delayed visits.
16084082|NCT02278744|Device|MRI and/or CT|
16084083|NCT02278731|Other|training program|Participants were randomly allocated to 1 of 3 groups: Pilates group (n=20), which underwent one-month (three times per week) training program with the Pilates method; PNF group (n=20), that underwent one-month (three times per week) training program using the PNF method; and Control group (n=18), that received no intervention during that one month and continued with their daily activities.
16084084|NCT02278718|Drug|NexoBrid|NexoBrid is an enzymatic debriding agent for Eschar Removal.
16084085|NCT02278718|Procedure|Standard of Care|Surgical or Non-Surgical methods for Eschar Removal
16084086|NCT02278705|Other|Attention to BMI|Evidence (using electronic health record data) denoting provider attention to about high BMI.
16084087|NCT02278705|Other|Attention to high-BMI-related Medical Risk|Evidence (using electronic health record data) denoting provider attention to high-BMI-related medical risk, including from high blood pressure/hypertension, cholesterol/dyslipidemia, blood sugar/diabetes, liver enzymes/fatty liver, and low vitamin D/vitamin-D deficiency.
16084088|NCT02278705|Other|No attention to high BMI or high-BMI-related medical risk|Lack of evidence (using electronic health record data) denoting provider attention to high BMI or high-BMI-related medical risk.
16084089|NCT02278692|Dietary Supplement|Vitamin K|Oral vitamin K
16084090|NCT02278692|Other|Placebo|Oral placebo tablet
16084091|NCT02278679|Procedure|Digital Rectal Exam|The DRE digital rectal exam is an essential component of physical examination, but physicians enter their residency having neither been appropriately exposed nor trained in performing DREs. , the attending physician, resident physician(s), and medical student(s) will each perform a digital rectal exam on the subject, and independently document their examination on the DiRECT instrument.
16084092|NCT02278666|Procedure|aortic valve replacement|aortic valve replacement with either biological prosthetic valve or mechanical valve
16084093|NCT02278666|Device|biological prosthetic valve|aortic valve replacement with either biological prosthetic valve or mechanical valve
16084094|NCT02278666|Device|Mechanical valve|aortic valve replacement with either biological prosthetic valve or mechanical valve
16084095|NCT02278653|Other|Questionnaires for the evaluation of Quality of Life|"European Organisation for Research and Treatment of Cancer (EORTC) QLQ-30 questionnaire, version 3.0, Global Quality of Life Score
~Short Form (36) health survey
~EORTC CR38
~Vaizey score
~Low Anterior Resection Syndrome (LARS) score
~International Index of Erectile Function for men
~International Prostate Symptom Score for men
~Female Sexual Function Index for women"
16084096|NCT02278653|Other|Manometry|Manometry is a tool to measure the anal sphincter function. Patients do not need any bowel preparation before this procedure. During the examination a catheter tip will be positioned in the rectum above the sphincter and a small balloon will be inflated. This balloon is connected to a device that registers the measurements. Patients will receive instructions; e.g. squeeze, push, and cough. The procedure takes approximately 10 minutes and is not experienced as painful. Several parameters will be measured: the mean basal pressure, the maximum squeeze pressure, first sensation, first urge to defecate and the maximum tolerable volume. The manometric measurement will take place on the same day as the endoscopy and MRI (standard follow-up).
16084097|NCT02278640|Device|Harmonic ACE®+7 Shears|Vessel/pedicle sealing performance assessed for transection and sealing of the of the uterine vasculature.
16084098|NCT02278627|Other|manual lymphatic drainage|
16084099|NCT02278614|Drug|T2347|T2347 eye drop solution is presented in SDU. It is supplied in 0.20 ml single use polyethylene containers.
16084100|NCT02278614|Drug|Xalacom|Xalacom® 0.01% eye drop solution is supplied in 2.5 ml multidose container.
16084101|NCT02278601|Device|epidural delivery system|epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution
16084102|NCT02278601|Drug|Ropivacaine|epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution
16084103|NCT02278601|Drug|Fentanyl|epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution
16084104|NCT02278588|Drug|Rasagiline|
16084105|NCT02278575|Drug|Atenativ|intravenous transfusion
16084106|NCT02278562|Drug|anakinra|100 mg in syringes; administered subcutaneously 3 times a week for 12 weeks (3 months)
16084107|NCT02278562|Drug|actos|30 mg capsules; administered orally 1 capsule per day for 12 weeks (3 months)
16084110|NCT02278510|Drug|Topotecan|Topotecan is a chemotherapy that is approved by the FDA to treat cancers. It is normally given by an intravenous injection, and not directly into a tumor. That is why it is considered to be an investigational drug for this study
16084111|NCT02278510|Drug|Gadolinium DTPA|Gadolinium DTPA is a contrast agent which will be added to topotecan to allow the investigators to observe where topotecan goes in tumors. Gadolinium DTPA is approved by the FDA for intravenous injection during an MRI scan. It is not approved by the FDA for administration directly into a tumor.
16084112|NCT02278510|Device|Cleveland Multiport Catheter|The Cleveland Multiport Catheter is a device that is not approved by the FDA and so it is classified as an investigational device. It has been designed to deliver drugs and other agents intended to treat cancers directly into the affected tissues. The Cleveland Multiport Catheter can be placed into a brain tumor only in the operating room. It is placed during an operation to perform a biopsy of brain tumors. Following the biopsy, a surgeon will place two catheters into the tumor with use of an image guided navigation system. Once each catheter has been placed, it will be secured into the scalp and the incision will be closed. The Cleveland Multiport Catheter will be left in place until the completion of the topotecan treatment.
16084113|NCT02278497|Other|ASSESSMENT OF CORONARY FLOW RESERVE BY PET-H215O AND FFR|
16084114|NCT02278484|Device|XprESS device and PathAssist confirmation tools|
16084115|NCT02278471|Drug|Polypill (atorvastatin, amlodipine, losartan, and hydrochlorothiazide)|
16084116|NCT02278458|Drug|icotinib|Three dose levels of icotinib are designed to be evaluated, 125 mg three times per day, 250 mg three times per day, and 375 mg three times per day. Dose escalations are based on predefined dose escalation decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at least 30% patients developed a dose limited toxicity.
16084117|NCT02278458|Drug|Gemcitabine|Gemcitabine: 1000 mg/m2 on Days 1, 8, and 15 of a 28 day cycle by IV administration every 4 weeks.
16084118|NCT02278445|Radiation|Doppler ultrasound|Recording Doppler ultrasound noninvasively from the right chest wall
16084119|NCT02278445|Device|Transthoracic Parametric Doppler (TPD) (Echosense Ltd., Haifa, Israel)|
16084120|NCT02278419|Drug|Simeprevir|Simeprevir 150 mg capsule orally, once daily for 8 weeks in Group A1, 12 weeks in Group A2 and Group B.
16084121|NCT02278419|Drug|Sofosbuvir|Sofosbuvir 400 mg tablet orally, once daily for 8 weeks in Group A1, 12 weeks in Group A2 and Group B.
16084122|NCT02278406|Other|Deep brain stimulator|We will measure brain oxygen levels with a non-invasive near infrared spectroscopy device.
16084123|NCT02278393|Other|1-Fermented Dairy Product with Phytosterols (test)|1- 3 bottles of test product/day
16084124|NCT02278393|Other|2-Fermented dairy Product with No Phytosterols (control)|2-3 bottles of control product/day
16084125|NCT02278380|Other|Low GI Standard Breakfast|Low GI Standard Breakfast
16084126|NCT02278380|Other|Medium GI Standard Breakfast|Medium GI Standard Breakfast
16084127|NCT02278380|Other|Enfamama A+|Nutritional pregnant milk supplement
16084128|NCT02278380|Other|Glucerna Triple Care|Nutritional product for diabetics
16084129|NCT02278380|Other|Dumex Precima|Pregnant and lactation women milk powder
16084130|NCT02278380|Other|Diasip|Nutritional drinks for diabetics
16084131|NCT02278380|Other|Test product|Test product not patented yet
16084132|NCT02278367|Drug|Flortaucipir F18|IV injection, 370 MBq (10 mCi), up to two doses
16084133|NCT02278367|Procedure|Brain PET scan|positron emission tomography (PET) scan of the brain
16084134|NCT02278354|Drug|Flortaucipir F18|IV injection, 370 megabecquerel (MBq) (10 mCi)
16084135|NCT02278354|Procedure|Brain PET scan|positron emission tomography (PET) scan of the brain 75-105 minutes post injection
16084136|NCT02278341|Drug|Roxadustat|Participants received initial dose of roxadustat orally as a tablet in doses of 100 mg, 150 mg or 200 mg, according to the average weekly dose of epoetin or darbepoetin alfa prior to randomization. Participants' roxadustat dosage was adjusted every 4 weeks to maintain Hb level within the target range 10.0 to 12.0 g/dL. Dose adjustment steps were as follows: 20, 40, 50, 70, 100, 150, 200, 250, 300, and 400 mg. Oral iron treatment of 200 mg was allowed for supplementation to support erythropoiesis. Treatment with intravenous iron was allowed only if certain protocol criteria were met.
16084137|NCT02278341|Drug|Epoetin alfa|Participants received epoetin alfa via intravenous or subcutaneous injection, once a week, twice a week, or three times a week (TIW). Epoetin alfa dosage was adjusted to maintain Hb level within the target range. Dosing of epoetin alfa was per UK SmPC of Eprex®. Participants received IV iron supplementation according to the standard of care.
16084138|NCT02278341|Drug|Darbepoetin alfa|Participants received darbepoetin alfa via intravenous or subcutaneous injection, once a week or once every other week. Darbepoetin alfa dosage was adjusted to maintain Hb level within the target range. Dosing of darbepoetin alfa was per EU SmPC of Aranesp®. Participants received IV iron supplementation according to the standard of care.
16084139|NCT02278341|Drug|Iron|Oral iron treatment was recommended for supplementation to support erythropoiesis and as first-line treatment for iron deficiency, unless participant was intolerant to this treatment. For participants receiving roxadustat the recommended daily dose was 200 mg of elemental iron. Participants were advised to take roxadustat at least 1 hour before or 1 hour after oral iron. Intravenous iron supplementation for participants receiving roxadustat was allowed if all of the following criteria were met: The participant's Hb level had not responded adequately to roxadustat following two consecutive dose increases or reached the maximum dose limit, and participant's ferritin was < 100 ng/mL (< 220 pmol/L) or TSAT < 20%, or the participant was intolerant of oral iron therapy. For participants treated with epoetin alfa or darbepoetin alfa, IV iron supplementation was given according to standard of care.
16084140|NCT02278328|Drug|STX209 (15mg)|"A randomized acute dose-response design will be employed with a total study duration of 3 weeks. At each visit, baseline MEG will be obtained followed by acute single-dose drug/placebo administration, followed 60 minutes later by repeat MEG. Each participant will receive a single dose of placebo in random order and a single dose of STX209 from smallest to largest (15mg, and 30mg). MRI and MRS will be performed immediately following MEG to provide an anatomic basis for source localization as well as to assess acute effects of STX209 administration on MRS estimates of GABA and glutamate. The STX209 (15mg) intervention is the low dose"
16084232|NCT02277730|Device|vasopressor delivery automated system|vasopressor delivery using phenylephrine and ephedrine
16084233|NCT02277730|Drug|phenylephrine|
16084234|NCT02277730|Drug|ephedrine|
16084141|NCT02278328|Drug|placebo|A randomized acute dose-response design will be employed with a total study duration of 3 weeks. At each visit, baseline MEG will be obtained followed by acute single-dose drug/placebo administration, followed 60 minutes later by repeat MEG. Each participant will receive a single dose of placebo in random order and a single dose of STX209 from smallest to largest (15mg, and 30mg). MRI and MRS will be performed immediately following MEG to provide an anatomic basis for source localization as well as to assess acute effects of STX209 administration on MRS estimates of GABA and glutamate. The placebo intervention is the non-active placebo control dose
16084142|NCT02278328|Drug|STX209 (30mg)|"A randomized acute dose-response design will be employed with a total study duration of 3 weeks. At each visit, baseline MEG will be obtained followed by acute single-dose drug/placebo administration, followed 60 minutes later by repeat MEG. Each participant will receive a single dose of placebo in random order and a single dose of STX209 from smallest to largest (15mg, and 30mg). MRI and MRS will be performed immediately following MEG to provide an anatomic basis for source localization as well as to assess acute effects of STX209 administration on MRS estimates of GABA and glutamate. The STX209 (30mg) intervention is the high dose"
16084143|NCT02278315|Drug|I-131-CLR1404|Single IV dose of I-131-CLR1404, increased/decreased by cohort
16084144|NCT02278315|Drug|dexamethasone|40 mg dexamethasone orally once weekly for up to 12 weeks
16084145|NCT02278315|Drug|I-131-CLR1404|Multiple IV dose of I-131-CLR1404, increased/decreased by cohort
16084146|NCT02278302|Drug|Aggrenox®|
16084147|NCT02278302|Drug|Placebo|
16084148|NCT02278302|Other|Ethanol|
16084149|NCT02278289|Device|ultrasound|Patients in the ultrasound therapy group were treated with US therapy for 5 minutes each session, twice per week for 8 weeks.
16084150|NCT02278289|Procedure|paraffin therapy|Patients in the paraffin therapy group were treated with the dip-and-wrap method of paraffin bath therapy in the hospital twice per week for 8 weeks. The temperature of the paraffin bath was maintained at approximately 55°C
16084151|NCT02278276|Drug|sodium polysulthionate|Bioavailable composition of α-sulfur
16084152|NCT02278276|Drug|Placebo|400 mg capsules containing placebo
16084153|NCT02278263|Drug|Tranexamic Acid|Given intravenously or topically
16084154|NCT02278263|Drug|Normal saline (0.9% NaCl)|Administered in all 3 groups
16084155|NCT02278250|Drug|M4344|Dose escalation of M4344 administered as a single agent.
16084156|NCT02278250|Drug|Carboplatin|Carboplatin will be administered in combination with escalated dose of M4344.
16084157|NCT02278250|Drug|M4344|Dose escalation of M4344 administered in a drug holiday schedule (different schedule with either 3 days once daily (QD) or BID followed by 4 days of pausing, 5 days of QD or BID followed by 2 days of pausing, 7 days of QD or BID dosing followed by 7 days of pausing or 14 days of QD or BID dosing followed by 7 days of pausing may be explored. Other dosing holiday schedules may be explored if agreed by the sponsor and Investigators) applies to A3.
16084158|NCT02278250|Drug|M4344|M4344 at the Recommended Phase 2 dose (RP2D) from Part A3 in expansion cohorts.
16084159|NCT02278237|Behavioral|VME Group|Received inhaler education through VME (virtual education module)
16084160|NCT02278224|Behavioral|Group based rumination focused CBT|The RFCBT is a group trans-diagnostic manual based psychotherapy for depression and anxiety. RFCBT focuses on increasing effective behaviour - i.e., not stopping rumination but making it functional. It's grounded within the core principles and techniques of CBT for depression with two adaptations: (1) a functional-analytical perspective using Behavioural Activation (BA) approaches, (2) an explicit focus on shifting processing style via imagery and experiential approaches.
16084161|NCT02278224|Behavioral|Group based CBT|The control group is gold standard group based CBT based on Becks manual for CBT for depression.
16084162|NCT02278198|Drug|rhTSH|Intramuscular injections of rhTSH (Thyrogen) will be given on days 1 and 2.
16084163|NCT02278185|Drug|Enzalutamide|Given PO
16084164|NCT02278185|Drug|leuprolide acetate|Given SC or IM
16084165|NCT02278185|Drug|goserelin acetate|Given SC or IM
16084166|NCT02278185|Drug|histrelin acetate|Given SC or IM
16084167|NCT02278185|Drug|triptorelin|Given SC or IM
16084168|NCT02278185|Drug|degarelix|Given SC or IM
16084169|NCT02278172|Dietary Supplement|Vitamin D|3000IU (75 μg) vitamin D in a commercially available oral spray solution
16084170|NCT02278172|Dietary Supplement|Placebo|Placebo oral spray solution manufactured to mimic the vitamin D oral spray
16084171|NCT02278159|Procedure|Peritoneal dialysis|
16084172|NCT02278159|Procedure|Home hemodialysis|
16084173|NCT02278146|Device|ParaPatch|A device for the treatment of urinary incontinence
16084174|NCT02278133|Drug|WNT974|
16084175|NCT02278133|Drug|LGX818|
16084176|NCT02278133|Biological|Cetuximab|
16084177|NCT02278120|Drug|LEE011|LEE011 600 mg daily oral
16084178|NCT02278120|Drug|Tamoxifen|tamoxifen 20 mg daily oral
16084179|NCT02278120|Drug|Letrozole|letrozole 2.5 mg daily oral
16084180|NCT02278120|Drug|Anastrozole|anastrozole 1 mg daily oral
16084181|NCT02278120|Drug|Goserelin|Goserelin 3.6 mg subcutaneous injection
16084182|NCT02278120|Drug|LEE011 Placebo|LEE011 placebo 600 mg daily oral
16084183|NCT02278107|Device|Tidal Assist Ventilator System|Tidal volume augmentation with supplemental oxygen. Source gas options: cylinder, concentrator, wall.
16084184|NCT02278107|Device|Nasal Cannula Oxygen|Standard oxygen therapy delivered by nasal cannula at 2-5 lpm based on patient requirements. Source gas options: cylinder, concentrator, wall.
16084185|NCT02278094|Device|Tongue Muscle Trainer (TMT)|Subject will be instructed to compress the Iowa Oral Performance Instrument (IOPI) IOPI's bulb using tongue in three directions (anterior and both lateral sides). Then, hold 30-35 seconds each time. Subjects will be encouraged to do 60 minutes of exercise daily then continue three to five times a week for a total of 3 months.
16084186|NCT02278094|Device|Threshold Inspiratory Muscle Trainer (TIMT)|Resistance of the TIMT devices will be set from 30% of the maximum inspiratory pressure. Nose clip follow by normal breathing. Seal the mouth to the device's mouth piece then inhale through the device. Subjects will be encouraged to do 60 minutes of exercise daily then continue three to five times a week for a total of 3 months.
16084235|NCT02277730|Device|manual vasopressor delivery|
16084862|NCT02272985|Other|NIRS (Invos)|All participants will undergo near infrared spectroscopy (NIRS) during the hemodialysis study session.
16084187|NCT02278094|Procedure|Walking Exercise|Subjects will be encouraged to perform walking exercise in the field 10000 steps/ 60 minutes daily then continue three to five times a week during first months. Followed by 12500 steps and 15000steps per day during the second and third months.
16084188|NCT02278094|Device|Continuous Positive Airway Pressure (CPAP)|CPAP regular therapy per day (use ≥ 4 h/day) then continue three to five times a week for a total of 3 months.
16084189|NCT02278081|Drug|lansoprazole|the lansoprazole will be taken orally.
16084190|NCT02278081|Drug|placebo|the lansoprazole placebo will be taken orally.
16084191|NCT02278068|Device|Metabolic Neuromodulation System (MNS)|Prospective, First-in-Human (FIH), multi-center, non-randomized trial to evaluate the initial safety and performance of hepatic sympathetic denervation to aid in glycemic control.
16084192|NCT02278055|Drug|Radium-223|
16084193|NCT02278042|Other|Beverage Consumption|
16084194|NCT02278003|Other|memory test|
16084195|NCT02278003|Drug|Propofol|
16084196|NCT02277990|Device|TYRX™ Absorbable Antibacterial Envelope|
16084197|NCT02277977|Other|Contrast enhanced ultrasound|Contrat enhanced ultrasound during septic shock
16084198|NCT02277951|Device|The Bonfils Intubation Fibrescope|Effectiveness and time to successful intubation will be measured.
16084199|NCT02277951|Device|The Video Rigid Flexing Laryngoscope|Effectiveness and time to successful intubation will be measured.
16084200|NCT02277951|Device|The C-MAC® S Video Laryngoscope|Effectiveness and time to successful intubation will be measured.
16084201|NCT02277951|Device|The Macintosh Laryngoscope|Effectiveness and time to successful intubation will be measured.
16084202|NCT02277938|Drug|Amantadine|Amantadine is a drug that has been on the market for several years and is currently approved for the treatment of Parkinson's disease and for prevention against influenza A infection. Amantadine may be of value in detecting the presence of cancer.
16084203|NCT02277925|Other|Polytetrafluoroethylene|Suture used to attach mesh during sacral colpopexy surgery
16084204|NCT02277925|Other|Polydioxanone|Suture used to attach mesh during sacral colpopexy surgery
16084205|NCT02277912|Device|navigated rTMS of motor cortex|Navigated repetitive transcranial magnetic stimulation of the motor cortex ( 10 Hz ) ,5 daily sessions per week for two weeks.
16084206|NCT02277912|Device|navigated rTMS of somatosensory cortex 2|Navigated repetitive transcranial magnetic stimulation of the secondary somatosensory cortex ( 10 Hz ), 5 daily sessions per week for two weeks
16084207|NCT02277912|Device|SHAM rTMS with SHAM block|Repetitive SHAM transcranial magnetic stimulation of the motor cortex ( 10Hz) 5 daily sessions per week for two weeks.
16084208|NCT02277899|Other|Communication regarding overweight status|Pediatrician-patient/parent communication regarding child's high weight status
16084209|NCT02277899|Other|Risk-factor assessment and counseling|Counseling regarding cardiovascular risk factor assessments/results.
16084210|NCT02277899|Other|Lifestyle behavior assessment and counseling|Counseling regarding diet and lifestyle changes to improve weight status.
16084211|NCT02277899|Other|Interval follow-up to readdress weight|Interval follow-up to readdress weight, prior to the next well-child visit one year later. Follow-up could include ongoing care through nutrition and/or an intensive weight-management program.
16084212|NCT02277899|Other|Patient-centered communication|Patient-centered communication will be scored as the ratio of patient to doctor-centered communication regarding weight topics. Means will be calculated for total and weight-communication-specific pediatrician, child, and parent-talk time, and patient, doctor, and the ratio of patient/doctor-centered communication scores. For the primary hypothesis, biomedical information-giving (for example, risk-factor communication) will be treated as patient-centered because the principal investigator's focus groups suggest that parents want this information, and prior research suggests that including biomedical-information giving improves the correlation of Roter's patient-centeredness measure with patient health status and satisfaction scores.
16084213|NCT02277886|Drug|sodium alginate|oral suspension, 50mg/ml, 20ml once at bed time
16084214|NCT02277886|Drug|esomeprazole|40mg/tablet, one tablet once before breakfast
16084215|NCT02277873|Behavioral|pregnancy|Observational study in order to establish relationship between moon and births
16084216|NCT02277860|Behavioral|Exercise|Aerobic and strength training using the Wii Fit for ≥ 30 min, ≥3 days/week, for 12 weeks, at a moderate intensity (Borg CR10 3-5).
16084217|NCT02277847|Drug|Idarubicin(8mg/m2) and cytosine arabinoside|IDA 8mg/M2 per day, D1-3. iv injection in 10 minutes;Ara-C：100-200mg/M2 per day, D1-7. administration advice: at first, 25 mg/M2 of Ara-C is given by fast intravenous injection, then 100 mg/M2 of Ara-C is given by continuous iv drip for 24 hours for successive 7 days.
16084218|NCT02277847|Drug|Idarubicin(10mg/m2), cytosine arabinoside|IDA 10mg/M2 per day, D1-3. iv. injection in 10mimutes;Ara-C：100-200mg/M2 per day, D1-7. administration advice: at first, 25 mg/M2 of Ara-C is given by fast intravenous injection, then 100 mg/M2 of Ara-C is given by continuous iv drip for 24 hours for successive 7 days.
16084219|NCT02277821|Device|Stendo pulsating suit System|The Stendo system, a multilayer pulsatile inflatable suit is applied to the lower limbs and the abdomen. This device induces a sequential compartmentalized compression synchronized with each diastolic phase of the cardiac cycle, each phase evolving centripetally (lower limbs to abdomen).
16084220|NCT02277808|Drug|500mg Amikacine (Amukin®) diluted in 4mL NaCl (0,9%)|
16084221|NCT02277808|Device|Respirgard II|
16084222|NCT02277808|Device|Isoneb®|
16084223|NCT02277795|Device|AccuCirc|Circumcision with the use of the AccuCirc device.
16084224|NCT02277782|Drug|Hydromorphone|
16084225|NCT02277782|Drug|Hyperbaric bupivacaine|
16084226|NCT02277782|Drug|Fentanyl|
16084227|NCT02277769|Drug|Dupilumab|Subcutaneous injection alternated among the different quadrants of the abdomen, upper thighs and upper arms.
16084228|NCT02277769|Drug|Placebo (for Dupilumab)|Subcutaneous injection alternated among the different quadrants of the abdomen, upper thighs and upper arms.
16084229|NCT02277756|Device|thermode|thermal stimulation with test thermode
16084230|NCT02277743|Drug|Dupilumab|Subcutaneous injection alternated among the different quadrants of the abdomen, upper thighs and upper arms
16084231|NCT02277743|Drug|Placebo (for Dupilumab)|Subcutaneous injection alternated among the different quadrants of the abdomen, upper thighs and upper arms
16084236|NCT02277717|Drug|SYD985 (trastuzumab vc-seco-DUBA)|IV (in the vein) infusion every three weeks. Number of Cycles: until cancer progression or unacceptable toxicity develops. Different doses.
16084237|NCT02277704|Drug|TNX-102 SL|
16084238|NCT02277704|Drug|Placebo|
16084239|NCT02277691|Drug|TAK-536TCH tablet|TAK-536TCH tablets
16084240|NCT02277691|Drug|TAK-536CCB tablet|TAK-536CCB tablets
16084241|NCT02277691|Drug|HCTZ 12.5 mg tablet|HCTZ tablets
16084242|NCT02277678|Drug|Opioid administration oxycodone|Epidural administration single dose through epidural catheter
16084243|NCT02277678|Drug|Opioid administration morphine|
16084244|NCT02277665|Behavioral|CUD Treatment|
16084245|NCT02277665|Behavioral|Tobacco Treatment|
16084246|NCT02277652|Device|The Miller Laryngoscope|Direct laryngoscopy
16084247|NCT02277652|Device|The Bonfils intubation fibrescope|Optical laryngoscopy
16084248|NCT02277652|Device|The GlideScope Ranger|Videolaryngoscopy
16084249|NCT02277652|Device|The Supraglottic Airway Laryngopharyngeal Tube (SALT)|Blind intubation
16084250|NCT02277639|Device|CliniMACs device|Reduced intensity conditioning with chemotherapy followed by stem cell transplant using the CliniMACs device to deplete CD3+ CD19+ peripheral stem cells.
16084251|NCT02277626|Device|Electro Flo 5000|Airway clearance device
16084252|NCT02277626|Device|Incourage Vest System|Airway Clearance Device
16084253|NCT02277613|Biological|AMI MultiStem cells|AMI MultiStem cells administration in coronary artery with a micro-infusion catheter.
16084254|NCT02277613|Other|Sham|Sham procedure using Micro-Infusion Catheter in coronary artery without injection.
16084255|NCT02277600|Drug|BMS-663068|BMS-663068
16084256|NCT02277600|Drug|Darunavir|Darunavir
16084257|NCT02277600|Drug|Cobicistat|Cobicistat
16084258|NCT02277587|Drug|Plenadren|Oral Tablets: 20-25-30 mg
16084259|NCT02277587|Drug|Conventional glucocorticoid therapy|Oral Tablets: 20-25-30- 37.5 mg
16084260|NCT02277574|Biological|AMP-110|2, 5, or 10 mg/kg
16084261|NCT02277574|Other|Placebo|Placebo
16084262|NCT02277561|Procedure|diffusion tensor imaging|Undergo VB-DTI
16084263|NCT02277561|Radiation|whole-brain radiation therapy|Undergo WBRT
16084264|NCT02277561|Radiation|stereotactic radiosurgery|Undergo SRS
16084265|NCT02277561|Procedure|contrast-enhanced magnetic resonance imaging|Undergo contrast-enhanced MRI
16084266|NCT02277561|Procedure|diffusion-weighted magnetic resonance imaging|Undergo DW MRI
16084267|NCT02277548|Drug|Lyrica 300 mg|Lyrica 300 mg per day
16084268|NCT02277548|Drug|Placebo|
16084269|NCT02277535|Other|Feedback/Reminder email.|
16084270|NCT02277522|Biological|RNA anti-CD19 CAR T cells|intravenously administered, RNA electroporated autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCRζ and 4-1BB (TCR /4-1BB) costimulatory domains (referred to as RNA CART19)
16084271|NCT02277509|Behavioral|Chinese DPP|"The Chinese DPP intervention will include core curriculum, stress reduction, physical activity sessions, and self-monitor diet and physical activity.
~."
16084272|NCT02277509|Behavioral|Minimal Intervention Control|Patients will receive printed diabetes prevention materials in Chinese. Materials will be from primary from the National Diabetes Education Program and from the New York City Department off Health and Mental Hygiene. Patients will receive an educational packet at randomization and quarterly thereafter.
16084273|NCT02277496|Behavioral|Toolkit Intervention|The toolkit intervention consists of strategies and activities to engage students (student toolkit) and school wellness councils (school toolkit) in addressing the six targeted behaviors of the 2010 Dietary Guidelines based on the principles of participatory action research. The intervention will promote goal setting and school-based food and physical promotion activities led by students as well as school wellness network development.
16084274|NCT02277483|Drug|LAIS®|10 X 1,000 / twice a week
16084275|NCT02277457|Radiation|PET-Adaptive RT|All patients will be treated with response-driven PET-adaptive RT. The radiation dose will be delivered in greater than or equal to 2.2 Gy per daily fraction to FDG-PET/CT-guided target volumes with the treatment duration limited to 30 fractions and total radiation dose limited to 66-80.4 Gy.
16084276|NCT02277457|Drug|Erlotinib|150 mg once daily
16084277|NCT02277457|Drug|Crizotinib|250 mg twice daily
16084280|NCT02277431|Dietary Supplement|Probiotic dietary supplement (Trenev Trio®)|"Trenev Trio® (healthcare professional line)/Healthy Trinity® (consumer line) is a dietary supplement that contains probiotics microenrobed in an oil matrix in a two-piece hard gel capsule. One capsule will be taken twice per day (am & pm) offering a total daily serving of:
~Lactobacillus acidophilus NAS super strain (10 billion Colony Forming Units [CFU])
~Bifidobacterium bifidum Malyoth super strain (40 billion CFU)
~Lactobacillus delbrueckii subspecies bulgaricus LB-51 super strain (10 billion CFU)"
16084281|NCT02277431|Dietary Supplement|placebo|
16084282|NCT02277418|Device|VAVL|Videolaryngoscope
16084283|NCT02277418|Device|MIL|Direct laryngoscopy
16084284|NCT02277405|Device|Shikani Optical Stylet|Optical intubation
16084285|NCT02277405|Device|Endoeye Flexible Intubation (LF-V)|endoscopy intubation
16084286|NCT02277392|Biological|Vaccine---primed, CD3/CD28---costimulated autologous peripheral blood T---cells|
16084287|NCT02277392|Biological|SB---485232 (Human recombinant Interleukin---18)|
16084288|NCT02277366|Procedure|Fluorescence Bronchoscopy/Narrow Band Bronchoscopy|Fluorescence Bronchoscopy and Narrow Band Bronchoscopy are used in the Fluorescence/Narrow Band Bronchoscopy group to make a diagnosis of lung cancer.
16084289|NCT02277353|Other|Fluid loading to evaluate fluid responsiveness|loading of hydroxyethyl starch 6ml/kg over 10-15min to all patients
16084900|NCT02272725|Drug|Placebo|Tasteless and inert visually identical (to ibuprofen) pills
16085459|NCT02268760|Drug|BILN 2061 ZW single rising doses|
16084290|NCT02277340|Procedure|EAPA|Under sedation and local anesthesia, a pit of pilonidal disease is widened, hair and debris removed and cavity first ablated by endoscopy assisted diathermy the filled with crystallized phenol. The remaining pits were also fulgurated.
16084291|NCT02277327|Behavioral|Plans of Action and Care Transitions|"Subjects randomized to the intervention will participate in action planning and care transitions (if hospitalized during the study period)"
16084292|NCT02277327|Behavioral|Routine Care|"Subjects randomized to the control group will continue to receive routine care within the medical home program"
16084293|NCT02277314|Procedure|Manual Small Incision Cataract Surgery|This cost-effective solution for removing cataracts, also known as Manual Small Incision Cataract Surgery (MSICS), is a positive alternative when Phaco is not an option due to costs. The procedure takes approximately 30 minutes and involves a mid-size incision and an intraocular lens (IOL), or artificial lens, replacing the natural lens. Following the procedure, patients may need glasses, and most will need bifocals, but overall vision will be significantly improved.
16084294|NCT02277301|Behavioral|Mellow Babies|Mellow Babies is an intervention designed for mothers with substantial problems in their relationships with their infants. Typically, participating mothers have mental health difficulties, problem drug use, learning difficulties, forensic issues or they may have children already looked after by the local authority.
16084295|NCT02277288|Other|Filled bladder arm|Bladder to be instilled with 200 cc fluid during cystoscopy and no catheter for all mid-urethral sling procedures.
16084296|NCT02277275|Dietary Supplement|BCAA|Branched chain amino acid(BCAA) pills will be provided to subjects 0.15g/kg of body weight per day for six months
16084297|NCT02277275|Dietary Supplement|Placebo|Placebo will be provided to the other two arms for six months
16084298|NCT02277262|Device|Biological swine dermis not cross-linked prosthesis positioning in incisional hernia prevention|The mesh placement will be preceded by the plane preparation. The subcutaneous tissue will be dissociated from the anterior rectum-muscles fascia. The retro-muscular rectum muscles plane will be dissected preparing a 5-6 cm pouch necessary to the prosthesis positioning. The mesh will be fixed with at least 8 long-lasting absorbable transfix stitched. The prosthesis will be placed with at least a 5 cm overlap. If the peritoneal plane can be sutured a Jackson-Pratt 10 suction drain will be placed under the prosthesis. A Jackson-Pratt 10 suction drain will always be placed over the prosthesis. Anterior rectum fascia will be closed by emi-continuous monofilament suture with an intermediate-reabsorbable-time suture. Another Jackson-Pratt 10 suction drain will be placed over the anterior fascia if the subcutaneous tissue is thick. No subcutaneous suture will be performed. Skin stapler or interrupted stitches will be used to close the skin plane.
16084299|NCT02277262|Procedure|Direct suture of the anterior abdominal wall fascia|Anterior rectum fascia will be closed by emi-continuous monofilament suture with an intermediate-reabsorbable-time suture. No subcutaneous suture will be performed. Skin stapler or interrupted stitches will be used to close the skin plane.
16084300|NCT02277249|Drug|Digoxin (transvaginal administration)|"Transvaginal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
16084301|NCT02277249|Drug|Digoxin (transabdominal administration)|"Transabdominal digoxin administration prior to second-trimester abortion. This is only listed as a Procedure/Surgery type intervention because the mode of digoxin administration (transvaginal versus transabdominal) is what is being studied."
16084302|NCT02277236|Radiation|DXA scanning|Exposure: Participants will undergo DXA scanning in the supine position per manufacturer guidelines to estimate absolute and percentage of total lean body mass (LBM) and body fat (BF).
16084303|NCT02277236|Radiation|CT imaging|Exposure: Estimates of intramuscular adipose tissue (IMAT) will be obtained with CT imaging. This measure will be restricted to a single leg (dominant side) in the mid-femur region, using a single 10mm axial image slice (120 kVp, 200 to 250 mA).
16084304|NCT02277223|Dietary Supplement|Curcumin|"Eligible patients will be randomized to either intervention of placebo groups. Randomization will be performed separately for patients receiving corticosteroids for induction in-order to ensure similar heterogeneity within groups. Induction: oral prednisone 1mg/kg up to 40 mg once daily for 2 weeks and then tapered down by 5 mg per week or 5-ASA 75 mg/kg/day divided to two doses. Maintenance: 5-ASA 75 mg/kg/day divided to two doses.
~Patients receiving corticosteroids for induction, whose PUCAI is >35 points at 2 weeks will be regarded as treatment failure. Patients receiving 5-ASA for induction with induction treatment failure will be re-randomized to receive oral corticosteroids induction with or without curcumin."
16084305|NCT02277223|Drug|Placebo|"Eligible patients will be randomized to either intervention of placebo groups. Randomization will be performed separately for patients receiving corticosteroids for induction in-order to ensure similar heterogeneity within groups. Induction: oral prednisone 1mg/kg up to 40 mg once daily for 2 weeks and then tapered down by 5 mg per week or 5-ASA 75 mg/kg/day divided to two doses. Maintenance: 5-ASA 75 mg/kg/day divided to two doses.
~Patients receiving corticosteroids for induction, whose PUCAI is >35 points at 2 weeks will be regarded as treatment failure. Patients receiving 5-ASA for induction with induction treatment failure will be re-randomized to receive oral corticosteroids induction with or without curcumin."
16084306|NCT02277210|Other|Flushing|aspiration of follicles that are larger than 10 mm on both sides followed by follicular flushing for up to 4 times. Follicular fluid and flushing will be examined by the embryologists to identify any oocytes.
16084307|NCT02277197|Drug|Ficlatuzumab|"Ficlatuzumab Concentrate for Injection, 20 mg/mL, is formulated in 10 mM histidine buffer pH 5.8. The formulation also includes 142 mM arginine (for isotonicity) and 0.01% polysorbate 80. The product is sterile filtered and aseptically filled into washed and depyrogenated 5 mL glass vials.The product is a clear to slightly opalescent, colorless to slightly yellow, solution.
~Ficlatuzumab Concentrate for Injection is to be administered by IV infusion as an admixture with normal saline solution. The admixture solution in an IV bag is connected to an infusion set containing a 0.22 µm low protein-binding in line filter. The filtered admixture solution is clear to slightly opalescent.
~Ficlatuzumab is to be stored under refrigerated conditions (2o C- 8oC)"
16084336|NCT02276989|Drug|Quinine|"On the morning of Days 8-11, subjects will be administered the same dose of PGB, now compounded with the QUIN.
~On Day 11, PK testing of QUIN and PGB will be repeated.
~On Day 12, subjects will be administered PGB and QUIN compounded with RIBO, and PK measures again collected.
~On Day 13 patients will be discharged with take-home doses of PGB that will taper to zero over the period of one week."
16084308|NCT02277197|Drug|Cetuximab|"Cetuximab is supplied as a 50-mL, single-use vial containing 100 mg of cetuximab at a concentration of 2 mg/mL in phosphate buffered saline. The solution should be clear and colorless and may contain a small amount of easily visible white amorphous cetuximab particulates. Cetuximab can be administered via infusion pump or syringe pump, it must not be administered as an IV push or bolus. Cetuximab must be administered with the use of a low protein binding 0.22-micrometer in-line filter. Maximum infusion rate should not exceed 5 mL/min.
~Store vials under refrigeration at 2C to 8C (36F to 46F). DO NOT FREEZE. Following the cetuximab infusion, a one-hour observation period is recommended."
16084309|NCT02277184|Drug|Ficlatuzumab|"Ficlatuzumab Concentrate for Injection, 20 mg/mL, is formulated in 10 mM histidine buffer pH 5.8. The formulation also includes 142 mM arginine (for isotonicity) and 0.01% polysorbate 80. The product is sterile filtered and aseptically filled into washed and depyrogenated 5 mL glass vials.The product is a clear to slightly opalescent, colorless to slightly yellow, solution.
~Ficlatuzumab Concentrate for Injection is to be administered by IV infusion as an admixture with normal saline solution. The admixture solution in an IV bag is connected to an infusion set containing a 0.22 µm low protein-binding in line filter. The filtered admixture solution is clear to slightly opalescent.
~Ficlatuzumab is to be stored under refrigerated conditions (2C - 8C)"
16084310|NCT02277184|Drug|Cisplatin|"Each vial contains 10 mg of DDP, 19 mg of sodium chloride, 100 mg of mannitol, and hydrochloric acid for pH adjustment. One vial is reconstituted with 10 ml of sterile water. The pH range will be 3.5 to 4.5.
~Cisplatin will be given as a bolus, infused over 1-2 hours along with appropriate hydration and anti-emetics.
~Reconstituted solution of cisplatin is stable for 20 hours when stored at 27°C and should be protected from light if not used within 6 hours. The vials and injection should not be refrigerated. Cisplatin has been shown to react with aluminum needles, producing a black precipitate within 30 minutes."
16084311|NCT02277184|Radiation|Intensity Modulated Radiotherapy (IMRT)|"Immobilization should be performed to ensure daily reproducibility of setup.Treatment planning CT scans will be required to define tumor, clinical and planning target volumes.The treatment planning CT scan should be performed with IV contrast. All tissues to be irradiated must be included in the CT scan.
~Targets are defined as primary (requiring a higher dose) and secondary (targets at lower risk requiring a lower dose). The primary target is the PTV3 of the primary tumor and lymph nodes containing clinical or radiographic evidence of metastases. The secondary target is the PTVs consist of an area at intermediate risk (PTV2) and that containing the lowest risk of lymph node involvement (PTV2).
~The treatment plan will be based on an analysis of the volumetric dose, including dose volume histogram (DVH) analyses of the PTV and critical normal structures. Inverse planning will be utilized to deliver optimal dose to the PTVs while excluding noninvolved normal tissue."
16084312|NCT02277171|Device|Nitric Oxide impregnated catheter|Patients undergoing radical prostatectomy will be catheterized for 7-14 days with Nitric Oxide impregnated Foley catheters
16084313|NCT02277158|Drug|Chemoradiotherapy|S-1 CCRT
16084314|NCT02277145|Biological|clinical grade umbilical cord mesenchymal stem cells|10^6 (1 million) /Kg/person cells of clinical grade umbilical cord MSCs will be injected after fully lavage of the localized lesions
16084315|NCT02277132|Drug|Sildenafil|Sildenafil 25 mg three times daily orally from randomization until delivery
16084316|NCT02277132|Drug|Placebo|Placebo tablets three times daily orally from randomization until delivery
16084317|NCT02277119|Device|Maestro|OCT machines used for diagnostic purposes
16084318|NCT02277119|Device|iVue|OCT machines used for diagnostic purposes
16084319|NCT02277106|Drug|SAGE-547|
16084320|NCT02277106|Drug|Placebo|
16084321|NCT02277093|Drug|Pacritinib|
16084322|NCT02277067|Drug|Carbetocin|Pabal 100 mcg iv infusion over 1 minute given after delivery of fetal head In the first group of patients, carbitocin 100 mcg will be given iv infusion over one minute after delivery of the head in cesarean section.
16084323|NCT02277067|Drug|Misoprostol|600 micro gram of misoprostol which is a prostaglandin E1 will be given per rectum for patients immediately postoperative.
16084324|NCT02277054|Device|Collagen-MPC cornea|Patients will undergo surgery using conventional anterior lamellar keratoplasty technique: diseased cornea will be trephined to approximately 50-90% of corneal thickness (depending on corneal ulcer or scar depth) and then a lamellar dissection will be created. Trephine diameter will depend on ulcer or leukoma maximal size. Alternatively a femtosecond laser may be used to create the dissection. A collagen-phosphorylcholine cornea 250-500 microns thick and equal or 0.25 mm larger diameter is placed and sutured. The sutures are superimposed and the implant and the sutures covered with a bandage contact lens. The sutures and bandage lens will be removed later after the initial healing period of 4 weeks or as determined by physician depending on the implant epithelial coverage.
16084325|NCT02277041|Drug|Carbetocin|Pabal 100 mcg iv infusion over 1 minute given after delivery of fetal head In the first group of patients, carbitocin 100 mcg will be given iv infusion over one minute
16084326|NCT02277041|Drug|Misoprostol|600 micro gram of misoprostol which is a prostaglandin E1 will be given per rectum for patients immediately postoperative.
16084327|NCT02277028|Behavioral|priming and task specific training|This task specific training protocol has been used in several clinical trials.
16084328|NCT02277015|Device|Miller Laryngoscope|Direct Laryngoscopy
16084329|NCT02277015|Device|The Berci-Kaplan DCI|Videolaryngoscope-1
16084330|NCT02277015|Device|The AirTraq|Videolaryngoscope-2
16084331|NCT02277015|Device|GlideScope GVL|Videolaryngoscope-3
16084332|NCT02277015|Device|The Pentax AWS|Videolaryngoscope-4
16084333|NCT02277002|Device|Cabin Air Filtration|
16084334|NCT02277002|Other|Placebo|No Cabin Air Filtration
16084335|NCT02276989|Drug|acetazolamide|"On evening of Day 0, subjects will arrive at the session previously stabilized on buprenorphine and pregabalin. Pregabalin titration = 6 days prior to Day 0, during which time they will receive 100mg/day x 2 days, 200mg/day x2 days, and 300mg/day x 2 days, with the subjects receiving the full dose of 400mg/day beginning Day 0.
~On Day 1, pregabalin PK measures will be collected.
~On the mornings (8am) of Days 1 - 5, PGB compounded with the first tracer, ACZ will be administered.
~On Day 5, subjects will again undergo PK testing on PGB + ACZ tracer.
~On Day 6, subjects will be administered PGB and ACZ compounded with RIBO, and PK measures again collected.
~On the mornings of Days 7-8 subjects will receive their PGB dose only."
16084418|NCT02276391|Drug|Telmisartan|
16084419|NCT02276378|Drug|Telmisartan low|
16084420|NCT02276378|Drug|Telmisartan high|
16084983|NCT02272153|Other|Egg Whole Grain|
16084337|NCT02276989|Drug|Riboflavin|"All subjects will receive riboflavin on the following days of the study:
~On Day 6, subjects will be administered PGB and ACZ compounded with RIBO, and PK measures again collected.
~On Day 12, subjects will be administered PGB and QUIN compounded with RIBO, and PK measures again collected."
16084338|NCT02276963|Drug|Ublituximab|Monoclonal antibody that specifically binds to the trans-membrane antigen CD20, which induces immune response that causes lysis of B cells.
16084339|NCT02276950|Procedure|Coronary artery bypass surgery|Primary isolated coronary artery bypass surgery with or without use of cardio-pulmonary bypass
16084340|NCT02276950|Procedure|Heart valve surgery|Heart valve surgery, aortic valve replacement or other heart valve procedures
16084341|NCT02276937|Drug|DVC1-0101|The investigational product will be drawn into a disposable 1 mL syringe using a 23G needle. A total of 0.5 mL of investigational product will be injected intramuscularly into each administration site. After administration, the administration sites will be wrapped with dressings.
16084342|NCT02276924|Device|Laser confocal microscopy|Patients undergoing a reno-ureteroscopy for diagnosis or treatment indication will receive an intra-vesical instillation of fluorescein (0.1%) for 5 minutes, followed by the laser confocal microscopy procedure.
16084343|NCT02276911|Drug|Ibuprofen|
16084344|NCT02276911|Other|normal saline|
16084345|NCT02276898|Drug|Hypertonic Saline 7%|PARI Hyper-Sal™ Sodium Chloride Solution - 7%
16084346|NCT02276898|Drug|Isotonic Saline 0.9% (Placebo)|
16084349|NCT02276872|Drug|oral treprostinil|
16084350|NCT02276859|Drug|insulin aspart|A kind of study bolus insulin will be insulin aspart if participant used insulin aspart before entering the trial
16084351|NCT02276859|Drug|insulin lispro|A kind of study bolus insulin will be insulin lispro if participant used insulin lispro before entering the trial
16084352|NCT02276859|Drug|insulin glulisine|A kind of study bolus insulin will be insulin glulisine if participant used insulin glulisine before entering the trial
16084353|NCT02276846|Device|Paclitaxel-Eluting Balloon|
16084354|NCT02276833|Other|intra-articular space injection of SVF|intra-articular injection of autologous adipose SVF derived in the same surgical procedure
16084355|NCT02276820|Biological|Viralym-A|"Follow-up Assessments: The timing of follow-up visits is based on the date of Viralym-A infusion. If a patient has multiple Viralym-A infusions the schedule resets again at the beginning so follow up relates to the last Viralym-A infusion.
~Follow up will occur at 7 days, 14 days, 21 days, 28 days, 42 days, 90 days, 180 days, and 365 days post enrollment."
16084356|NCT02276807|Behavioral|Brief Behavioral Activation|This is a 4-session individual workshop using behavioral activation techniques.
16084357|NCT02276807|Other|Usual Care|Primary care patients will be referred to the integrated behavioral health provider to receive brief treatment in primary care.
16084358|NCT02276794|Other|Thrust Manipulation|After positioning patients in right side-lying, a rotational TM technique will be addressed at the L4-L5 lumbar segments. The treating therapist will have up to two attempts to apply the TM.
16084359|NCT02276794|Other|Non-thrust manipulation (NTM)|A grade III rotational non-thrust manipulation will be addressed at the L4-L5 lumbar segments. Thirty oscilations will be performed.
16084360|NCT02276768|Drug|GIC-1001 375 mg TID|GIC-1001 375 mg TID mid-dose, oral tablet, white-coated, to be taken with water
16084361|NCT02276768|Drug|GIC-1001 500 mg TID|GIC-1001 500 mg TID high-dose, oral tablet, white-coated, to be taken with water
16084362|NCT02276768|Drug|GIC-1002 345 mg TID (equimolar to GIC-1001 375 mg TID)|GIC-1002 345 mg TID mid-dose, oral tablet, white-coated, to be taken with water
16084363|NCT02276768|Drug|GIC-1002 460 mg (equimolar to GIC-1001 500 mg)|GIC-1002 460 mg TID high-dose, oral tablet, white-coated, to be taken with water
16084364|NCT02276768|Other|Placebo|Placebo identical and matching active drugs GIC-1001 and GIC-1001
16084365|NCT02276755|Dietary Supplement|Cholecalciferol (vitamin D3)|14000 IU vitamin D3 weekly Experimental group will receive vitamin D supplement (Tishcon, USA).
16084366|NCT02276755|Other|Placebo|Placebo group will receive placebo (Tishcon, USA) weekly.
16084367|NCT02276742|Behavioral|Social Cognitive Theory|focuses on the role played by self-referent thought in the maintenance of behavior change. Self- efficacy (e.g., the participant's confidence in their ability to engage in healthier behavior) is derived from four major sources of information: mastery experiences, social modeling, verbal persuasion, and physiological states
16084368|NCT02276742|Other|Monitoring|Technology-based self-monitoring reduces information processing demands by making relevant nutritional information readily available. Technology-based self-monitoring also can be used by interventionists to reduce information processing burden by using it for targeted counseling. For example, simultaneous consideration of all pertinent dietary recommendations would likely be overwhelming for an obese person with diabetes and CKD. By using an electronic log accessible to the interventionist, such a person could initially focus on calorie restrictions, with the interventionist stepping-in when problematic behaviors become evident.
16084369|NCT02276729|Other|Mirror Box Therapy|Mirror box therapy (MBT) is a relatively new therapeutic intervention that is gaining recognition within OT for the potential it offers in rehabilitation of upper limb function in stroke patients. It is postulated that mirror visual feedback can stimulate neural recovery in the brain using mirrored movements of the non-affected upper limb. It is thought that visual feedback helps recruit dormant motor pathways that replace the damaged pathways and encourage the return of movement to improve upper limb function.
16084370|NCT02276716|Dietary Supplement|Phosphatidylserine|Phosphatidylserine will be titrated starting at 300mg/day dose for two months to 600mg/day dose for 2 months, then 800 mg/day dose for a final 2 month period.
16084371|NCT02276703|Device|Skin Conductance Monitor|monitors skin conductance values
16084372|NCT02276690|Biological|hepcidin|"In order to assess iron deficiency by innovative method (dosage of Hepcidin), an additional collection of blood will be done at day 0 (and weekly until Intensive Care Unit discharge) and at Day 15 after Intensive Care Unit discharge.
~Treatement of Iron deficiency anaemia and anaemia of chronic disease using intravenous iron (± erythropoietin) will be encouraged (or not) according to hepcidin levels"
16084373|NCT02276690|Biological|ferritin and transferrin saturation|"In order to assess iron deficiency by using usual biomarkers (ferritin and transferrin saturation), collection of blood will be done at day 0 (and weekly until Intensive Care Unit discharge) and at Day 15 after Intensive Care Unit discharge.
~Treatement of Iron deficiency anaemia and anaemia of chronic disease using intravenous iron (± erythropoietin) will be encouraged (or not) according to ferritin levels."
16084374|NCT02276677|Drug|Oxytocin|Single dose, intranasal
16084375|NCT02276677|Drug|Placebo|Single dose, intranasal
16084376|NCT02276664|Behavioral|Self-Help (SHI)|The newly revised Stop Smoking for Good booklets.
16084377|NCT02276664|Behavioral|Usual Care (UC)|The existing Clearing the Air smoking-cessation manual published by the National Cancer Institute (NCI).
16084378|NCT02276638|Device|Specular Microscope Nidek CEM-530|Nidek CEM-530
16084379|NCT02276638|Device|Specular Microscope Konan CELLCHEK XL|Konan CELLCHEK XL
16084380|NCT02276625|Biological|rabies vaccine|Compare ID administration to IM administration. 1 visit schedule.
16084381|NCT02276612|Drug|E/C/F/TAF|150/150/200/10 mg fixed-dose combination (FDC) tablet administered orally once daily with food
16084382|NCT02276599|Procedure|Volume expansion|Fluid bolus of 0.9% normal saline 10 mL/kg over 10 minutes
16084383|NCT02276586|Procedure|Horizontal Tooth preparation|Round parallel chamfer diamond burs were used for teeth preparation; coarse first (151 micron) and extra-fine after (25 micron)
16084384|NCT02276586|Procedure|Vertical Tooth preparation|Long flame diamond burs were used for teeth preparation; coarse first (151 micron) and extra-fine after (25 micron)
16084385|NCT02276573|Biological|buccal cavity sample|
16084386|NCT02276560|Drug|Neoadjuvant Cisplatin, nab-paclitaxel|Cisplatin (75mg/m2) D1, nab-paclitaxel 125 mg/m2) D1, 8, 15; repeat each 28 D cycle x 2 then surgery
16084387|NCT02276560|Drug|Adjuvant Cisplatin,nab-paclitaxel|Cisplatin 75mg/m2 D1,nab-paclitaxel 125mg/m2 D1, 8, 15, repeat each 28D cycle x 2
16084388|NCT02276560|Drug|Adjuvant cisplatin+pemetrexed or cisplatin+gemcitabine|Cisplatin 75mg/m2 D1 + pemetrexed 500mg/m2 D1 or Gemcitabine 1000 mg/m2 D1, 8 (if SqCC) repeat each 21 D Cycle x 4
16084389|NCT02276547|Device|Mitral valve replacement|Transcatheter mitral valve replacement
16084390|NCT02276534|Behavioral|SENSE Theatre|A peer-mediated, theatre-based intervention.
16084391|NCT02276534|Behavioral|Delayed Intervention|
16084392|NCT02276521|Biological|Cervarix®|All groups will received one dose of Cervarix® vaccine
16084393|NCT02276508|Drug|E. coli Nissle 1917|Participants will all take E. coli Nissle 1917 orally administered medication for 30 days
16084394|NCT02276495|Other|ACB Control - 20 ml saline injection for ACB|Adductor Canal Block Control (20 ml saline injection)
16084395|NCT02276495|Drug|ACB Study - 20 ml 0.5% Ropivacaine for Adductor Canal Block|Adductor Canal Block Study (20 ml 0.5% Ropivacaine)
16084396|NCT02276495|Drug|Local infiltration - 100 mLs of a solution containing: Ropivacaine + Epinephrine + Ketorolac + Clonidine + 0.9% Normal saline|"100 mLs of a solution containing:
~Ropivacaine 2 mg/mL (49.25 mL) + Epinephrine 1 mg/mL (0.5 mL) + Ketorolac 30mg/mL (1mL) + Clonidine 100 mcg/mL (0.8 mL) + 0.9% Normal saline (48.45 mL)"
16084397|NCT02276482|Drug|Tedizolid Phophate|Tedizolid Phophate 200 mg, IV and/or oral for 6 days
16084398|NCT02276482|Drug|Antibiotic comparator|Antibiotic comparator drug, IV and/or orally for 10 days. Antibiotic comparator included the following: Vancomycin, Linezolid, Clindamycin, Flucloxacillin, Cefazolin, Cephalexin.
16084399|NCT02276482|Drug|Aztreonam|In countries and/or sites where aztreonam is available, adjunctive aztreonam (IV) may be initiated on Day 1 or during the first 3 days of treatment if the participant is determined or suspected to have an infection with gram-negative aerobic pathogens.
16084400|NCT02276482|Drug|Metronidazole|Metronidazole (IV or oral) may be initiated on Day 1 or during the first 3 days of treatment if the participant is determined or suspected to have an infection with anaerobic pathogens.
16084401|NCT02276469|Behavioral|peer support|peer support is delivered by persons with a severe mental illness after the experience of recovery and after absolving a one year education to support others on their way to recovery
16084402|NCT02276456|Behavioral|Follow-up Appointment- early vs standard|Patient will undergo early follow-up (within 7 days of discharge) of discharge
16084403|NCT02276443|Drug|Chemotherapy|Undergo standard chemotherapy
16084404|NCT02276443|Other|Laboratory Biomarker Analysis|Correlative studies
16084405|NCT02276443|Procedure|Lymph Node Biopsy|Undergo baseline lymph node evaluation
16084406|NCT02276443|Procedure|Ultrasonography|Undergo standard ultrasound
16084407|NCT02276430|Other|Vena punction|Once 90 ml
16084408|NCT02276417|Other|Blood collection|Blood will be collected from patient at baseline, day 1, day 4, day 7 and weekly until week 6 as long as the patient is still hospitalized. Blood will also be collected at the one year appointment.
16084409|NCT02276417|Other|Urine collection|Urine will be collected from patient at baseline, day 1, day 4, day 7 and weekly until week 6 as long as the patient is still hospitalized. Urine will also be collected at the one year appointment.
16084410|NCT02276417|Other|Bioimpedance Analysis|The bioimpedance analysis will be performed at baseline, day 14 or discharge from hospitalization, month 3, month 6, and month 12.
16084411|NCT02276417|Other|Cognitive Function Tests|Cognitive function tests will be administered at 3, 6 and 12 months.
16084412|NCT02276417|Other|Quality-of-life Questionnaires|Quality-of-life questionnaires will be administered at baseline, 3, 6 and 12 months.
16084413|NCT02276417|Other|Physical Function Tests|Physical function tests will be administered at baseline, day 14 or discharge from hospital 3, 6 and 12 months.
16084414|NCT02276417|Other|Blood Collection|The healthy volunteer participants will donate a blood sample. These controls will allow the investigators to determine if the values obtained are accurate, reliable, and repeatable.
16084415|NCT02276404|Behavioral|relaxation training|"The relaxation sessions comprise an introduction in 3 relaxation techniques conducted by a mind-body therapist: Body Scan, mindfulness meditation and imagination. Patients also receive a CD with different relaxation exercises and the instruction to exercise daily at home for at least 15 minutes."
16084416|NCT02276404|Other|acupuncture|The acupuncture treatment comprises needling of 6 standardized acupoints: Pericardium 6, Stomach 36, Large intestine 4, Spleen/Pancreas 10, Dumai 20, Liver 3, Shenmen. Additional points can be chosen individual.
16084417|NCT02276391|Drug|Telmisartan/HCTZ combination|
16084428|NCT02276339|Other|Exercise|The exercise intervention will consist of an individual home-based progressive eccentric-concentric strengthening programme. Patients will be reviewed every two weeks during their rehabilitation; exercises will be progressed accordingly by their physiotherapist.
16084429|NCT02276326|Dietary Supplement|VSL#3 sachets|4 sachets a day for 4 months
16084430|NCT02276313|Device|Passeo-18 Lux|Endovascular Therapy
16084431|NCT02276300|Drug|Cyclophosphamide|Treatment of mild Endoxan application three days before Her2 vaccination
16084432|NCT02276300|Drug|Sargramostim|Sargramostim is part of Her2 vaccination
16084433|NCT02276300|Drug|HER2-Peptid-Vakzine|Her2 vaccination is supplemented by Sargramostim and Aldara Creme application
16084434|NCT02276300|Drug|Imiquimod|Imiquimod is part of Her2 vaccination
16084435|NCT02276274|Drug|SYR-322-MET|Oral administration of SYR-322-MET
16084436|NCT02276261|Procedure|Vaginal cuff closure - vertical|Vaginal cuff is closed vertically.
16084437|NCT02276261|Procedure|Vaginal cuff closure - horizontal|Vaginal cuff is closed horizontally.
16084438|NCT02276248|Radiation|Intensity-modulated radiation therapy|total dose: 50 to 56 grays per fraction: 2 grays
16084439|NCT02276248|Drug|GDP chemotherapy|gemcitabine (1000mg/m2 intravenously over 30 minutes on days 1 and 8), cisplatin (25mg/m2 intravenously over 60 minutes on days 1-3), and dexamethasone (20mg/d orally on days 1-4 and days 11-14), which was administered every 21 days.
16084440|NCT02276235|Device|Catgut embedding group|"An extensive form of acupuncture that involves weekly infixing self-absorptive chromic catgut sutures into acupoints with a specialised needle under antiseptic precautions. The catgut then stimulate those points over a long period. The stainless-steel acupuncture needles (3.8cm long) was inserted into 23 gouge needle as plunger with chromic catgut in front of the syringe needle. Catgut will be embedding in acupoints as below.
~Acupoints: Qihai (REN-6), Shuifen (REN-9), bilateral Shuidao (ST-28),bilateral Siman (K-14) ,zusanli(ST-26)"
16084441|NCT02276235|Device|sham catgut embedding group|"The stainless-steel acupuncture needles (3.8cm long) was inserted into 23 gouge needle as plunger without chromic catgut in front of the syringe needle. Catgut will be embedding in acupoints as below.
~Acupoints: Qihai (REN-6), Shuifen (REN-9), bilateral Shuidao (ST-28),bilateral Siman (K-14) ,zusanli(ST-26)"
16084442|NCT02276222|Drug|SUN-101 50 mcg BID eFlow (CS) nebulizer|SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer
16084443|NCT02276222|Drug|Spiriva® 18 mcg QD Handihaler|Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
16084444|NCT02276209|Drug|Dasotraline|Dasotraline 4 mg once daily
16084445|NCT02276209|Drug|Dasotraline|Dasotraline 6 mg once daily
16084446|NCT02276209|Other|Placebo|Placebo once daily
16084447|NCT02276196|Drug|Lixisenatide|GLP-1 receptor agonist
16084448|NCT02276196|Drug|Insulin glulisine|Insulin analogue
16084449|NCT02276183|Dietary Supplement|Nutrition intervention, test formula|
16084450|NCT02276183|Behavioral|progressive physical activity|Tai Chi; dynamic strength training (knee extension, knee flexion, hip extension, side leg raise, plantar flexion); flexibility warm up and cool down (shoulder and upper arm stretch, hamstrings stretch, calf stretch, ankle stretch); aerobic fitness training(walking on even flat ground); balance training(standing on one foot; heel-to-toe walk; toe stand)
16084451|NCT02276144|Other|Liver ultrasound|For evaluate whether fatty liver is exist or not
16084452|NCT02276131|Device|Vigilant Diabetes Management Application|Human factors and usability assessment of the device in the hands of diabetes subjects and caregivers
16084453|NCT02276118|Device|device: e.motion PS Pro|patients will undergo total knee arthroplasty with e.motion PS Pro implant
16084454|NCT02276118|Device|device : Genesis II|patients will undergo total knee arthroplasty with Genesis II implant
16084455|NCT02276105|Other|Questionnaires|On three time-points (Baseline, Retest, Follow-Up), each participant has to fill out the questionnaires: Michigan Hand Questionnaire, EuroQol EQ-5D-5L and the Short Form SF-12 Health Survey
16084456|NCT02276092|Other|antimicrobial stewardship|A member of the antimicrobial stewardship program will prospectively review the patient's medical record and make recommendations to the most responsible physician in the care of that patient
16084457|NCT02276079|Behavioral|Aerobic Exercise|Aerobic exercise will consist of riding a stationary bicycle at moderate intensity for 2 consecutive, 20-minute periods with a 5-minute break in between. Moderate intensity is defined as maintaining 65-75% of estimated maximum heart rate based on the calculation (HRmax = 208 - 0.7 × age).
16084458|NCT02276079|Behavioral|Non-Aerobic Exercise|Non-Aerobic exercise will consist of very low-intensity movements including static stretching and toning exercises.Participants will complete 2 consecutive, 20-minute periods with a 5-minute break in between, mirroring the aerobic exercise condition. Heart rate will be monitored by research staff to ensure that it remains below 50% of estimated maximum heart rate.
16084459|NCT02276066|Other|Iohexol|Both groups of sepsis participants will receive a normal saline dilution of Iohexol 0.5-1 ml given by IV push. Blood or urine will be collected prior to the injection and at approximately 1, 2, 3, and 4 hours after the injection for glomerular filtration rate measurements. This test will be repeated in one year.
16084460|NCT02276066|Other|Urine Collection|Both groups of sepsis participants will have urine collected for at least 4 hours to as long as 24 hours or more. The urine volume determined and a sample sent to the lab for determination of creatinine and urea concentration.
16084461|NCT02276066|Other|Blood samples|Both groups of sepsis participants will provide peripheral blood samples to the research staff. The samples will be sent to the laboratory for serum creatinine and cystatin C results.
16084462|NCT02276040|Drug|periarticular bupivicaine and liposomal bupivicaine|Participants will receive Exparel (liposomal bupivacaine). Exparel is a FDA approved product. Exparel is an extended-release formulation of bupivacaine consisting of microscopic lipid-based particles that diffuse over an extended period. The result is pain relief that can last up to 96 hours after surgery. Extended-release liposomal bupivacaine-based analgesics were shown to provide extended pain relief and decrease opioid (pain medication) use. At the conclusion of the total joint arthroplasty procedure, Exparel is administered via injection into the joint (periarticular bupivicaine and liposomal bupivicaine).
16084463|NCT02276027|Drug|BYL719|BYL719 was dosed as 350 mg once daily. On the first day of each cycle, patient received a prescription of adequate drug supply for self-administration at home. The investigator must emphasized compliance and instructed the patient to take BYL719 exactly as prescribed.
16084464|NCT02276027|Drug|INC280|INC280 was dosed as 600 mg (tablet) or 400mg(Capsule) twice daily. On the first day of each cycle, patient received a prescription of adequate drug supply for self-administration at home. The investigator must emphasized compliance and instructed the patient to takeINC280 exactly as prescribed.
16084465|NCT02276027|Drug|LDK378|LDK378 was dosed as 750 mg once daily. On the first day of each cycle, patient received a prescription of adequate drug supply for self-administration at home. The investigator must emphasized compliance and instructed the patient to take LDK378 exactly as prescribed.
16084466|NCT02276027|Drug|MEK162|MEK162 was dosed as 45 mg twice daily. On the first day of each cycle, patient received a prescription of adequate drug supply for self-administration at home. The investigator must emphasized compliance and instructed the patient to take MEK162 exactly as prescribed.
16084467|NCT02276014|Dietary Supplement|Beta-carotene|
16084468|NCT02276001|Drug|K-877|
16084469|NCT02276001|Drug|Cyclosporine|
16084470|NCT02275988|Drug|K-877|
16084471|NCT02275988|Drug|Clarithromycin|
16084472|NCT02275975|Drug|K-877|
16084473|NCT02275975|Drug|Fluconazole|
16084474|NCT02275962|Drug|K-877|
16084475|NCT02275962|Drug|Rifampin|
16084476|NCT02275949|Device|acupuncture|Acupuncture needles are inserted at the acupoints Zusanli(ST 36), Neiguan(PC 6), Gongsun(SP 4), and Xiangu(ST 43) bilaterally.
16084477|NCT02275949|Device|Electroacupuncture|The electric stimulator will be connected to the handles of each needles on the ST 36 and PC 6 bilaterally with 5Hz.
16084478|NCT02275949|Device|Intradermal acupuncture|Intradermal acupuncture needles with tape are inserted on the ST36, PC6, SP4, ST43 bilaterally and maintained until the next session.
16084479|NCT02275949|Device|Mock transcutaneous electrical nerve stimulation|Electrical insulator are attached on the ST36 and PC6 bilaterally, the same electric stimulator will be connected on the points with the same parameters as the study group, but without current intensity.
16084480|NCT02275949|Device|sham intradermal acupuncture|Intradermal acupuncture needles are put over the tape not penetrating the skin.
16084481|NCT02275936|Drug|N91115|S Nitrosoglutathione Reductase Inhibitor
16084482|NCT02275923|Device|Reveal LINQ™ Insertable Cardiac Monitor|Insertable cardiac monitor
16084483|NCT02275910|Drug|E7090|
16084484|NCT02275897|Procedure|Slow Speed of spinal injection|Speed of injection over 60 seconds
16084485|NCT02275897|Procedure|Fast Speed of spinal injection|Speed of injection over 15 seconds
16084486|NCT02275884|Dietary Supplement|Dark chocolate (85% cocoa)|
16084487|NCT02275884|Dietary Supplement|White chocolate (0% cocoa)|
16084488|NCT02275871|Other|MRI|High risk screening MRI will be performed as part of the patient's routine care.
16084489|NCT02275871|Other|CESM|After the MRI is complete, the patient will be brought to the mammography department for the contrast enhanced mammogram. The contrast enhanced mammogram will be independently interpreted by two study radiologists (randomly assigned) who are blinded to the MRI. They will then compare to the MRI to determine clinical follow-up. Any finding seen on MRI will be followed according to the MR protocol. Any finding seen on CESM only, will have a diagnostic work-up with mammography and ultrasound. If this work-up is negative, then follow-up CESM exams will be performed. Each patient will be followed for 2 years to determine sensitivity and specificity for both modalities.
16084490|NCT02275858|Device|Stiffening wire|Stiffening wire
16084491|NCT02275858|Device|Placebo wire|Placebo wire
16084492|NCT02275845|Drug|Metformin|Metformin twice daily 500 mg for the first week, after that twice daily 1000 mg (from 14 weeks pregnancy untill delivery)
16084493|NCT02275845|Other|control diet|2000 calories/day diet, with an adequate distribution of carbohydrates during the day
16084494|NCT02275832|Drug|3 % Minoxidil lotion|
16084495|NCT02275832|Drug|Placebo|
16084496|NCT02275819|Other|Exercise|Exercise (walking 3 times a week for 60 minutes) or Inspiratory Muscle Therapy (breathing against an inspiratory resistive load 3 times a week for up to 60 minutes)
16084497|NCT02275806|Drug|Irinotecan|
16084498|NCT02275806|Drug|Cisplatin|
16084499|NCT02275780|Drug|Doravirine|Doravirine 100 mg tablet administered p.o., q.d.
16084500|NCT02275780|Drug|Darunavir|Darunavir 800 mg tablet administered p.o., q.d.
16084501|NCT02275780|Drug|Ritonavir|Ritonavir 100 mg tablet administered p.o., q.d.
16084502|NCT02275780|Drug|TRUVADA™ or EPZICOM™/KIVEXA™|The investigator selects either TRUVADA™, a tablet containing 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate, p.o., q.d., or EPZICOM™/KIVEXA™, a tablet containing 600 mg abacavir sulfate and 300 mg lamivudine, p.o., q.d.
16084503|NCT02275767|Device|50% cortical/50% cancellous FDBA|Ridge preservation after tooth extraction using 50% cortical/50% cancellous FDBA
16084504|NCT02275767|Device|100% cortical FDBA|Ridge preservation after tooth extraction using 100% cortical FDBA
16084505|NCT02275767|Device|100% cancellous FDBA|Ridge preservation after tooth extraction using 100% cancellous FDBA
16084506|NCT02275754|Behavioral|PN+LCNC|Patient Navigation plus LIVESTRONG Cancer Navigation Center (PN+LCNC): Participants assigned to this group will be assisted by the patient navigator with their health-related needs. The patient navigator will call the study participant on a weekly basis for the first three months of their participation in the study, and on a monthly basis thereafter to see if study participant needs anything pertaining to their cancer care.
16084507|NCT02275754|Behavioral|PN Only|Participants will be navigated by PN on request
16084508|NCT02275741|Biological|prophylactic vaccine (tetanus, diphtheria, pertussis, poliomyelitis, influenza, hepatitis A, hepatitis B, tick-borne encephalitis, meningococcal, pneumococcal)|Publically recommended protective vaccines in MS patients, vaccination applied according to the manufacturers description
16084509|NCT02275728|Other|Pelvic floor muscle training|assessment and intervention group with a training of the pelvic floor muscles, another group with training of the pelvic floor muscles and electromyographic biofeedback and a control group will be held. All groups respond to a questionnaire of quality of life. At the end, all groups will be reassessed and compare the effectiveness of interventions between groups.
16084510|NCT02275728|Other|Eletromyography Biofeedback|
16084628|NCT02274792|Drug|Etanercept|Etanercept produced using the serum free process (SFP)2 was supplied in a single-use 1 mL prefilled syringe for subcutaneous injection.
16085460|NCT02268760|Drug|Placebo|
16084511|NCT02275715|Behavioral|Parent Training Program|An 11-session manualized behavioral parent training program for the treatment of feeding problems teaching parents to use a range of behavioral procedures to address a variety of common feeding problems.
16084512|NCT02275702|Drug|Dexamethasone IV|It will be administered at the induction of the anesthesia
16084513|NCT02275702|Drug|Saline solution|
16084514|NCT02275689|Procedure|Arthroscopic acromioplasty|Surgical intervention With arthroscopic acromion resection
16084515|NCT02275689|Procedure|Microtenotomy|Arthroscopic radiofrequency microtenotomy of rotator cuff tendon
16084516|NCT02275676|Other|bioelectrical impedance analysis|
16084517|NCT02275676|Other|indirect calorimetry|
16084518|NCT02275663|Drug|Azacytidine|
16084519|NCT02275663|Drug|Fludarabine|
16084520|NCT02275663|Drug|Cytarabine|
16084521|NCT02275663|Drug|Filgrastim|G-CSF
16084522|NCT02275650|Radiation|nbUVB|2 SED nbUVB exposure will be given every other week
16084523|NCT02275637|Device|implantable cardioverter defibrillator|
16084524|NCT02275611|Drug|intranasal oxytocin spray|Administration of oxytocin in a nasal spray
16084525|NCT02275611|Drug|Intranasal Placebo Spray|Intranasal Placebo Spray
16084526|NCT02275598|Drug|Brentuximab vedotin|1.8 mg/kg, IV (in the vein) on day 1 of each 28 day cycle. Number of Cycles: 2
16084527|NCT02275598|Drug|ABVD|Doxorubicin 25 mg/m2 IV, Bleomycin 10,000 units/m2 IV, Vinblastine 6 mg/m2 IV, Dacarbazine 375 mg/m2 IV on days 1-15 of each 28 day cycle. Number of Cycles: 3 or 6 according to initial disease stage.
16084528|NCT02275585|Other|Event of portal vein thrombosis|There is no intervention over patients. They are followed during 3 years to look after any event of portal vein thrombosis
16084529|NCT02275572|Procedure|Pharmacist Intervention|
16084530|NCT02275559|Behavioral|Mindfulness Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR) program consists of 8 weekly classes plus an all-day class to train participants in mindfulness and its application, including addressing challenges arising from chronic diseases and life stresses.
16084531|NCT02275559|Behavioral|Healthy Living Course (HLC)|The Healthy Living Course (HLC) consists of 8 weekly classes plus an all-day class providing lectures and discussions about health-related topics. The purpose of the HLC is to match the MBSR for time, attention and group support
16084532|NCT02275546|Drug|Placebo vaginal ring|Drug-free placebo vaginal ring
16084533|NCT02275546|Device|Single-use, non-sterile applicator|Single-use, non-sterile, plastic applicator for insertion of vaginal ring.
16084534|NCT02275533|Other|Clinical Observation|Undergo standard of care clinical observation
16084535|NCT02275533|Other|Laboratory Biomarker Analysis|Correlative studies
16084536|NCT02275533|Biological|Nivolumab|Given IV
16084537|NCT02275520|Device|NIO Adult device|IO access-1
16084538|NCT02275520|Device|Bone Iniection Gun|IO access-2
16084539|NCT02275520|Device|EZ-IO|IO access-3
16084540|NCT02275520|Device|Jamshidi Intraosseous Needle|IO access-4
16084541|NCT02275520|Device|Cook Intraosseous Needle|IO access-5
16084542|NCT02275507|Device|Masimo Rainbow Sensor|Non-Invasive Hemoglobin Measurement
16084543|NCT02275494|Procedure|Total hip arthroplasty|Cemented or uncemented total hip arthroplasty. No other intervention than observing patients operated according to routine practise at an orthopaedic department.
16084544|NCT02275481|Drug|Arformoterol tartrate inhalation solution|Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer with a face mask or mouthpiece connected to an air compressor
16084545|NCT02275481|Drug|Tiotropium|Tiotropium 18 mcg (SPIRIVA) will be administered QD (morning) via the HandiHaler®.
16084546|NCT02275468|Drug|Fu-zheng-qu-zhuo (FZQZ) oral liquid|FZQZ oral liquid is a herbal medicine, composed of astragalus, angelica root, rhubarb, etc, with the effect of reinforcing Qi and activating blood, dissolving dampness and downbearing turbid.
16084547|NCT02275455|Behavioral|real life situations|Four phases will be carried out on autism participants and aged-marched controls: 1) 24-hour baseline pre-experiment (physical activity, sleep), 2) 2-hour in real life situation, 3) 30-minute in a quiet environment, interrupted by a few seconds stressful sound, 4) an interview to get comments and feelings about events that triggered anxiety. Autism and control participants will be together for phases 2 and 3, revealing different physiological responses to the same situations, and thus identifying potentially problematic events.
16084548|NCT02275442|Other|EPICES scale|
16084549|NCT02275429|Procedure|Blood test|blood will be drawn the day before the race (day 0), upon completion of the race (between 27 and 67 hours after departure), and on days 7 and 28
16084550|NCT02275416|Drug|Ipilimumab|
16084551|NCT02275416|Biological|UV1 vaccine|
16084552|NCT02275416|Biological|GM-CSF|
16084553|NCT02275403|Procedure|Acupuncture|10 x weekly sessions (40 minutes per session) of acupuncture by a trained therapist.
16084554|NCT02275403|Other|Medication taken to manage the symptom burden of CIPN|Standard of care medication to manage CIPN symptoms, as determined by a clinician in accordance with local trust policy. The standard care for CIPN includes a variety of oral medications to manage the altered sensations caused by damage to the peripheral nerves. These oral medications include, but are not limited to; Gabapentin, Amitriptyline and Pregabalin. In addition, medicated creams and gels may be used.
16084555|NCT02275390|Behavioral|Nurse-led Psycho-education (or SPBB: self-learning program)|"The program was modified from the psycho-educational, motivation-driven and emotionally supportive programs developed and previously tested by the research team in Chinese people with different kinds of serious mental illness, mainly including schizophrenia spectrum disorders and mood disorders by Chien and his colleagues in 2012, and adherence therapy for people with psychotic disorders by Gray et al. (2010).
~[Note: SPBB consists of 5 modules (Module 1: Caregiver's well-being; Module 2:Getting the best out of support services; Module 3:Well-being of the person with schizophrenia; Module 4:Dealing with the [psychosocial] effects of the illness; and Module 5: Dealing with [physical and mental health] effects of the illness).]"
16084808|NCT02273375|Drug|Placebo|
16084809|NCT02273362|Drug|Erlotinib|Given PO
16084810|NCT02273362|Drug|Erlotinib Hydrochloride|Given PO
16084811|NCT02273362|Other|Laboratory Biomarker Analysis|Correlative studies
16084556|NCT02275390|Behavioral|Usual Psychiatric Outpatient Care|These services consisted of medical consultation and treatment by the attending psychiatrist (i.e., around every four weeks), brief education sessions (i.e., 3 or 4 one-hour sessions) on mental illness and treatment received by psychiatric nurses, and advices and referrals for community mental health and social welfare services available and/or family counseling by a psychiatric nurse or medical social worker in each clinic.
16084557|NCT02275377|Other|Inspiratory muscle training (IMT)|Participants will receive IMT for 30 min, 7 times per week for 8 weeks using Inspiratory muscle trainer device (PowerBreathe). During training, participants will be instructed to maintain diaphragmatic breathing with a breathing rate of 15-20 cycles/min. Inspiratory load will be set at 40% of maximum static inspiratory pressure, and weekly training loads will be adjusted to maintain 40% of MIP. Each week, six training sessions will be held at home and a training session will be supervised in the research center.
16084558|NCT02275377|Other|Sham IMT|Participants will receive IMT for 30 min, 7 times per week for 8 weeks using Inspiratory muscle trainer device (PowerBreathe). During training, participants will be instructed to maintain diaphragmatic breathing with a breathing rate of 15-20 cycles/min, but without a load generating resistance. Each week, six training sessions will be held at home and a training session will be supervised in the research center.
16084559|NCT02275364|Device|Test strip|Class I device for the application to the nose to facilitate better air flow through the nose
16084560|NCT02275364|Device|Placebo strip|Placebo strip
16084561|NCT02275364|Other|Nasal spray|Nasal decongestant to be used on a single occasion (one spray per nostril), 20 minutes prior to commencing the third MRI scanning sessions.
16084562|NCT02275351|Drug|SM04554|Topical solution, applied once a day
16084563|NCT02275351|Drug|Vehicle|Topical solution, applied once a day
16084564|NCT02275338|Drug|Lanreotide Autogel|120mg administered via deep subcutaneous injection at Day 0 and Day 28.
16084565|NCT02275325|Other|Preoperative vestibular rehabilitation|12 one-hour sessions with exercises of balance on unstable conditions (foam, tilt of the platform, biofeedback)
16084566|NCT02275299|Drug|Iguratimod|Iguratimod 25 mg/tablet, taken orally, 2 tablets/day (bid),52 weeks
16084567|NCT02275299|Drug|Leflunomide|Leflunomide 10 mg/tablet, taken orally, 2 tablets/day (bid),52 weeks
16084568|NCT02275299|Drug|Methotrexate|Methotrexate 2.5 mg/tablet, taken orally once a week, 4 tablets/week,52 weeks
16084569|NCT02275286|Drug|Trabectedin|"Escalating or deescalating dose of 1.3 or 1.5mg/m2, i.v 24h, once every 3 weeks.
~Cohort A: unlimited cycles Cohort B: 3 cycles Cohort C: 3 cycles"
16084570|NCT02275286|Radiation|Radiotherapy|3D conformal radiotherapy (3D-CRT) or intensity modulated radiotherapy (IMRT) providing: Cohort A: 30Gy in 10 fractions (3Gy/fraction) Cohort B: 45Gy in 25 fractions (1.8Gy/fraction) Cohort C: 45Gy in 25 fractions (1.8Gy/fraction)
16084571|NCT02275260|Device|Cerebral Diffusion-Weighted Magnetic Resonance Imaging|Patients undergo a cerebral Diffusion-Weighted Magnetic Resonance Imaging (DW-MRI)
16084572|NCT02275260|Device|Transesophageal Echocardiography|Patients undergo a Transesophageal Echocardiography prior to the ablation itself
16084573|NCT02275260|Other|Paperbased neurocognitive testing|To assess the impact of PVI on the patient's neurocognitive status
16084574|NCT02275247|Drug|Stellate Ganglion Block|stellate ganglion block will be administered using either 6-8mL saline (Group 1) or 0.25% ropivacaine 6-8mL (Group 2)
16084575|NCT02275234|Other|Psychological intervention|Psychological support via clinic visit, helpline and telephone calls
16084576|NCT02275208|Procedure|SIPS the stomach, intestinal, pylorus, sparing procedure|Bariatric Procedure
16084577|NCT02275182|Drug|Dexmedetomidine|0.5μg/kg Dexmedetomidine as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/min and stopped 30 minutes before the surgery over.
16084578|NCT02275182|Drug|Saline|0.5μg/kg saline as initial loading dose is given for 15 minutes before induction of anesthesia, followed by a maintenance infusion of 0.4μg/kg/min and stopped 30 minutes before the surgery over.
16084579|NCT02275169|Drug|Urofollitropin|Urofollitropin 75 IU 2 ampoules three times a week for three months
16084580|NCT02275169|Other|Placebo|Placebo ampoules administered three times a week for three months
16084581|NCT02275156|Biological|Evolocumab|Administered by subcutaneous injection
16084582|NCT02275143|Radiation|CT TAP Scan|Modification of chest CT protocol in the routine CT TAP: The Research CT of Thorax will be acquired as per the routinely performed CTCA with inclusion of the lung apices. Therefore the study will be acquired axially with prospective gating.
16084583|NCT02275130|Procedure|Calcium Hydroxyapatite|Surgical augmentation of the vocal cords with injection of calcium hydroxyapatite
16084584|NCT02275130|Device|Radiesse Voice (Calcium Hydroxyapatite)|
16084585|NCT02275117|Biological|ALD403|
16084586|NCT02275117|Biological|Placebo|
16084587|NCT02275104|Device|Contrast-enhanced ECG-gated multi-detector computed tomography|Depending on potential contra-indications to iodine-enhanced computed tomography. It will be performed using the usual method on a 64-slice dual energy scanner. Data will be acquired after the injection of 120 mL iodine contrast media. Contrast will be injected at the rate of 4 mL/s without additional saline flush in order to obtain homogeneous enhancement of the 4 cardiac chambers, there by simplifying subsequent segmentation. The objective will be to obtain a 3-dimensional imaging of cardiac structures
16084588|NCT02275104|Device|Magnetic resonance imaging|Depending on potential contra-indications to gadolinium-enhanced magnetic resonance. It will be performed on the 1.5 Tesla clinical device associated to MUSIC equipment (Magnetom Avanto, Siemens, Erlangen, Germany). Myocardial fibrosis will be imaged using a free-breathing delayed-enhancement method initially developed for atrial imaging. The method uses a 3-dimensional, inversion recovery-prepared, ECG-gated and respiratory-navigated Turbo Fast Low Angle Shot sequence with fat saturation. Acquisition will be initiated 15 minutes after the injection of a double-dose of gadolinium-based contrast media.
16084589|NCT02275104|Device|Positron emission tomography|Only in patients with a contra-indication to magnetic resonance imaging. It will be performed on a PET/CT 600 device. Acquisition will be preceded by a standard metabolic preparation for 18 fluoro-deoxy-glucose viability imaging. The objective will be to obtain a 3-dimensional imaging of ventricular scar.
16084812|NCT02273362|Other|Quality-of-Life Assessment|Ancillary studies
16084813|NCT02273349|Device|Lung Volume Reduction Coil (PneumrX Inc.)|Endoscopic Lung Volume Reduction
16084590|NCT02275104|Device|Body surface mapping|It will be obtained using a 252-electrode vest. The position of each electrode with respect to epicardium will be assessed at multi-detector computed tomography prior to mapping. In patients referred for ventricular arrhythmia, body surface mapping will aim at recording the clinical arrhythmia whenever possible. In patients referred for atrial arrhythmia, body surface mapping will aim at recording atrial fibrillation.
16084591|NCT02275104|Procedure|Cardiac ablation procedure|Ventricular procedures will be performed endocardially using trans-septal or retro-aortic approach, potentially combined with sub-xiphoid epicardial access. Atrial procedures will be performed endocardially using trans-septal approach to access the left atrium. Bi-atrial bipolar contact mapping will be performed at high density during atrial fibrillation prior to ablation.
16084592|NCT02275078|Behavioral|COPD self-management using an action plan|"Behavioral: Self-management education on the use of a self-administered prescription for exacerbation.
~Patients will be instructed to start treatment within 48 hours of experiencing an acute exacerbation of COPD and/or after starting their self-administered prescription."
16084593|NCT02275078|Device|Telesystem-Phone self-assessment/reporting system|Phone Self-Assessment/Reporting System. The second component of the intervention is the use of a computer-linked interactive phone assessment/reporting system that can assess respiratory status and notify the nurse case manager as needed
16084594|NCT02275078|Other|Nurse case manager support|Support:Nurse Case Manager Phone Support . The nurse case manager will call patients under two conditions. The first is to provide regularly scheduled follow-up education and support.The nurse case manager will also phone patients in response to answers they have provided to the phone system. i.e Worsening COPD status
16084595|NCT02275065|Drug|Bictegravir|Bictegravir tablet(s) administered orally once daily
16084596|NCT02275065|Drug|Placebo|Placebo to match bictegravir administered orally once daily
16084597|NCT02275052|Drug|UMEC/VI DPI|The DPI will contain a total of 30 doses. Each DPI will be comprised of two double-foil, laminate blister strips. Each blister of one strip will consist of 62.5mcg of UMEC blended with lactose and magnesium stearate while each blister of other strip will consist of 25 mcg of VI blended with lactose and magnesium stearate. Each actuation of the DPI will deliver the contents of one blister from each strip simultaneously
16084598|NCT02275052|Drug|Placebo DPI|The placebo DPI, identical in appearance to the inhaler containing active study medication, will have two blister strips, each containing 30 blisters of lactose and magnesium stearate.
16084599|NCT02275052|Drug|Albuterol/salbutamol MDI|Albuterol/salbutamol MDI (metered-dose inhaler) or nebules will be permitted throughout the study as rescue medication, for use as-needed. Albuterol/salbutamol will be sourced from local commercial stock or provided centrally from GlaxoSmithKline. Nebules will not be supplied.
16084600|NCT02275039|Biological|modified vaccinia virus ankara vaccine expressing p53|Given SC
16084601|NCT02275039|Drug|gemcitabine hydrochloride|Given IV
16084602|NCT02275039|Other|laboratory biomarker analysis|Correlative studies
16084603|NCT02275026|Procedure|Functional magnetic resonance imaging|Diffusion tensor imaging
16084604|NCT02275013|Drug|Levosimendan|
16084605|NCT02275000|Other|5 Day Physiotherapy Programme|The experimental group will complete a 5 day physiotherapy programme consisting of education, movement retraining and a self management plan.
16084606|NCT02275000|Other|Physiotherapy|Treatment as usual physiotherapy. The participant will be referred to their closest NHS outpatient neuro-physiotherapy service.
16084607|NCT02274987|Other|Specialized tumor board recommendation|A combination of up to four FDA approved drugs based on the molecular profile of the patient's tumor as determined by gene expression analysis, WES and predictive modeling.
16084608|NCT02274987|Radiation|Standard radiation therapy|Initial therapy will consist of standard radiation therapy per institutional guidelines followed by molecular based therapy with FDA approved drugs.
16084609|NCT02274974|Drug|Lidocaine|•The wound of C.Swill be infiltrated before closure of the skin, with 20 ml of 2% lidocaine.
16084610|NCT02274974|Drug|lidocaine and Epinephrine|The wound of C.S will be infiltrated before closure of the skin, with 20 ml of 2% lidocaine and epinephrine in related dose manner 1:200.000.
16084611|NCT02274961|Drug|S-pantoprazole 10mg|
16084612|NCT02274961|Drug|Placebo|
16084613|NCT02274948|Drug|Metformin|Metformin in the form of 500mg tablets were administer to the Metformin group
16084614|NCT02274948|Drug|Placebo|A Placebo tablet physically and chemically similar to Metformin tablets except for the absence of the active ingredient was used
16084615|NCT02274935|Other|Exercise|Balance and gait exercise twice a week for an hour
16084616|NCT02274909|Other|TRAINING PROGRAM|Sixty healthy elderly women were randomly divided into 3 groups: Pilates group (PG), PNF group (PNFG) and Control group (CG). Pilates and PNF groups underwent one-month training program with Pilates and PNF methods, respectively. CG received no intervention along the one month.
16084617|NCT02274896|Device|PD Catheter group|PD catheter
16084618|NCT02274883|Dietary Supplement|Enriched Protein Fractions|Enriched protein fractions
16084619|NCT02274883|Dietary Supplement|Protein Fractions|Protein fractions
16084620|NCT02274870|Drug|Liposome Bupivacaine|Administered via local tissue infiltration around the knee joint
16084621|NCT02274870|Drug|Bupivacaine HCl|Administered via CFNB
16084622|NCT02274857|Procedure|Standard PVI Ablation|Standard PVI procedure without FIRMap.
16084623|NCT02274857|Procedure|FIRM-Guided Procedure and PVI|FIRM-guided procedure followed by conventional ablation including PVI.
16084624|NCT02274844|Behavioral|Living Well with Diabetes Program|The intervention participants will receive the Living Well with Diabetes Program. The program will consist of educational DVDs with integrated storytelling about how community members accepted their disease and overcame barriers to medication adherence, plus one-on-one telephonic peer coaching
16084625|NCT02274831|Other|Email Reminder of need to follow up with primary physician|
16084626|NCT02274818|Behavioral|Flexible Duty Hour Schedule|"IM programs randomized to intervention will be allowed to construct flexible duty hour schedules that comply with 3 rules:
~No more than 80 hours of work per week (when averaged over 4 weeks)
~1 day off in 7 (when averaged over 4 weeks)
~In-house call no more frequently than every 3rd night (when averaged over 4 weeks)"
16084627|NCT02274805|Procedure|Adults presenting for surgery in the neck area|
16084984|NCT02272153|Other|Cereal Refined grain|
16084629|NCT02274779|Drug|ELIGARD|"Hormone therapy is recommended Eligard 45 mg acting for 6 months. It will be ideally administered the day of start of radiation therapy or within 3 months before the first day of radiotherapy.
~Nevertheless, free prescription is left to investigators. When using other hormonal strategies (anti-androgen agonists, LHRH antagonists or LHRH), an administration for six months will be critical."
16084630|NCT02274766|Drug|ADS-5102|Oral capsules to be administered once nightly at bedtime, for 13 weeks.
16084631|NCT02274766|Other|Placebo|Oral capsules to be administered once nightly at bedtime, for 13 weeks.
16084632|NCT02274740|Drug|LIXISENATIDE AVE0010|Pharmaceutical form:solution Route of administration: subcutaneous
16084633|NCT02274740|Drug|metformin|Pharmaceutical form:tablet Route of administration: oral
16084634|NCT02274714|Other|Questionnaire Only|Subjects will have an interview with a study coordinator to fill out questionnaires for the study
16084635|NCT02274701|Other|Holistic Needs Assessment|An assessment completed by the patient in cancer care. It is recommended that this assessment is completed at key points in the care pathway, such as at diagnosis, post treatment and beginning of end of life care. The aim of this assessment is to allow the patient to discuss their most important needs as identified by them. The clinician will take any appropriate action. This may range from listening to the patient to referring to another member of the multi-disciplinary team.
16084636|NCT02274688|Behavioral|Stepped Care Management|Case management, information technology/mHealth innovations, stepped-up psychopharmacology and psychotherapy elements.
16084637|NCT02274675|Device|Robot-assisted therapy for wrist and forearm|Robot therapy by using a single degree reconfigurable robot to train for wrist and forearm rehabilitation training.
16084638|NCT02274675|Other|Standard rehabilitation therapy|Standard therapy of stroke rehabilitation including speech, physical, occupational therapies and group activities
16084639|NCT02274662|Biological|Cultured Thymus Tissue|"Subjects receive cultured thymus tissue which is implanted into the quadriceps muscle. Subjects may receive pre and/or post-implantation immunosuppression.
~Potential subjects are screened for eligibility. The thymus tissue (from an unrelated donor), the donor, and the donor's mother are screened for safety. Cultured thymus tissue is implanted into the subject's quadriceps muscle under general anesthesia in the operating room. Two to three months post-implantation, if medically stable, subjects may undergo an allograft biopsy. Subjects undergo laboratory testing for approximately one year post-implantation. At year 2 post-implantation, subjects are contacted for data collection."
16084640|NCT02274662|Procedure|Blood Draw|
16084641|NCT02274662|Drug|Rabbit Anti-Thymocyte Globulin and Cyclosporine or Tacrolimus|RATGAM and Cyclosporine or Tacrolimus may be given, depending on the patient. The doses, timing, and trough levels will vary depending on the patient's clinical condition.
16084642|NCT02274649|Behavioral|one-to-one peer mentoring|Each patient received one-to-one peer mentoring each week during rehabilitation and for 90 days post discharge
16084643|NCT02274649|Behavioral|general peer support|General (traditional) peer support includes introduction and provision of support services upon request
16084644|NCT02274636|Dietary Supplement|Xylitol|A comparison between discs and gel
16084645|NCT02274623|Drug|CTAP101 Capsules|escalating doses
16084646|NCT02274610|Drug|Docetaxel-PNP|Docetaxel Polymeric Nanoparticle Formulation
16084647|NCT02274610|Drug|Taxotere|Docetaxel
16084648|NCT02274597|Device|metraux epitympanic thermometer|accuracy of epitympanic temperature measurement in different environmental settings
16084649|NCT02274584|Genetic|Anti-CD30 CAR T cells|Autologous 4th generation withdrawal lentiviral-transduced anti-CD30 CAR T cells
16084650|NCT02274571|Drug|TSEC (Tissue-selective estrogen complexes)|Duavee™, combination of CE(conjugated equine estrogens) and BZA (bazedoxifene)
16084651|NCT02274571|Other|Placebo|non active
16084652|NCT02274558|Drug|NBI-98854|NBI-98854 40 mg capsules
16084653|NCT02274558|Drug|Placebo|NBI-98854 placebo capsules
16084654|NCT02274545|Biological|H7N9 Anhui 2013/AA ca|10^7.0 fluorescent focus units (FFU); 0.5 mL of vaccine will be delivered as a nasal spray by an Accuspray device (0.25 mL per nostril)
16084655|NCT02274545|Biological|Inactivated subvirion H7N9 vaccine|30 mcg
16084656|NCT02274532|Device|SoftHand|Biomechanical, ADL, and functional testing.
16084657|NCT02274519|Other|Tai Chi|Arm 1
16084658|NCT02274519|Other|Education|Arm 2
16084659|NCT02274506|Drug|Cyclophosphamide|60 mg/kg by vein on Days -8 and -7.
16084660|NCT02274506|Drug|Fludarabine|25 mg/m2 by vein on Days -6 to -2.
16084661|NCT02274506|Procedure|T-Cell Infusion|T-cells infused no sooner than 48 hours and no later than 1 week post completion of chemotherapy on Day 0.
16084662|NCT02274493|Device|da Vinci® Robotic Surgical System|Da Vinci Robotic Surgical system to be used in procedures that harvest the latissimus dorsi muscle for reconstructive procedures
16084663|NCT02274493|Procedure|LD muscle flap harvest procedure|Latissimus dorsi muscle flap harvest procedure using da Vinci® Robotic Surgical System for use in reconstructive surgery.
16084664|NCT02274493|Procedure|Reconstructive surgery|Reconstructive surgery is considered to be standard of care.
16084665|NCT02274493|Behavioral|Questionnaires|Questionnaire about pain, as well as participant's shoulder, arm, and hand range of motion completed at baseline, and at follow up visits 3-6.
16084666|NCT02274480|Device|cardiac MRI with DWI|
16084667|NCT02274467|Device|Trans-catheter electric stimulation test|
16084668|NCT02274454|Drug|Oxytocin|Experiments will be conducted with some myometrial strips pretreated with oxytocin, and others without any oxytocin pretreatment
16084669|NCT02274454|Drug|Calcium|Calcium will be applied to the myometrial strips in 3 concentrations; 1.25mM (low), 2.5mM (normal) and 5.0mM (high). Myometrial strips will be either oxytocin pretreated, or non-oxytocin pretreated.
16084670|NCT02274428|Drug|pneumostem|human umbilical cord blood derived mesenchymal stem cells
16084671|NCT02274415|Biological|Vaccination with the combined vaccine (Prevenar13 ®)|
16084672|NCT02274415|Biological|Vaccination with the polysaccharide vaccine (Pneumo 23 ®)|
16084673|NCT02274402|Biological|blood sampling|Blood sample of 4 ml at enrolment and then at two following visits
16084674|NCT02274389|Drug|No Intervention|This is an observational study and participants did not receive any intervention in this study. Participants initiating bedaquiline (BDQ) treatment as decided by healthcare provider, will be prospectively observed.
16084675|NCT02274363|Other|No Intervention|Participants will not receive any intervention in this study. Participants with chronic plaque type psoriasis will be assessed at a single time point, primarily for severity of plaque-type psoriasis Participants will not be followed over time. Data will be collected from the medical consultation notes, medical records and during interviews.
16084676|NCT02274350|Radiation|radiation therapy|Radiation therapy either in the form of external beam radiation or radioactive gold seeds planted directly in the prostate.
16084677|NCT02274337|Drug|AC0010|patients take avitinib orally once per day at different dose
16084678|NCT02274324|Dietary Supplement|different diets|3 different diets: A\B\C
16084679|NCT02274311|Drug|Clomiphene Citrate|Clomiphene citrate, 50 mg, orally for three months
16084680|NCT02274298|Behavioral|CKD feedback and tools|people in the intervention arm will receive feedback on ckd quality indicators and tools to help in the detection and management of ckd
16084681|NCT02274285|Biological|DTaP-IPV/Hib Combined vaccine|0.5 mL, Subcutaneously. 3 times, each given 3 to 8 weeks apart
16084682|NCT02274285|Biological|DTaP-IPV vaccine and Hib vaccine|0.5 mL each, Subcutaneously, 3 times, each given 3 to 8 weeks apart
16084683|NCT02274285|Biological|DTaP-IPV/Hib Combined vaccine|0.5 mL, Intramuscularly. 3 times, each given 4 to 8 weeks apart
16084684|NCT02274272|Other|ADR-1|two ADR-1 capsules, once daily, QD
16084685|NCT02274272|Other|GMNL-263|two GMNL-263 capsules, once daily, QD
16084686|NCT02274272|Other|placebo|two placebo capsules, once daily, QD
16084687|NCT02274259|Drug|Aflibercept|Aflibercept injection is given at every visit. Time to next treatment according to presence of macular edema
16084688|NCT02274259|Drug|Ranibizumab|Ranibizumab injection is given at every visit. Time to next treatment according to presence of macular edema
16084689|NCT02274246|Drug|gadobutrol|Gadobutrol administration in healthy volunteers
16084690|NCT02274233|Drug|SP-420|
16084691|NCT02274220|Dietary Supplement|Rapid advancement of feeds|Feeding is initiated on first postoperative day. Bolus feeds are started at 1 mL/kg every three hours and up-titrated by 1 mL/kg every feed (Q 3 hours) to a goal of 10 mL/kg/feed (equivalent to approximately 50 kcal/kg/day). Feeding volume will exceed 20 mL/kg/day by 6 hours following protocol initiation and reach target feeds by 27 hours of protocol initiation.
16084692|NCT02274220|Dietary Supplement|Standard advancement of feeds|Feeding is initiated on first postoperative day. Bolus feeds are started at 3 mL every three hours for 24 hours. Bolus feeds then up-titrated by 1 mL/kg every-other feed (Q 6 hours) for 24 hours. Bolus feeds then up-titrated by 1mL/kg every feed for to a goal of 10 mL/kg/feed (equivalent to approximately 50 kcal/kg/day). Feeding volume will reach target feeds by 60-63 hours after protocol initiation.
16084693|NCT02274207|Device|NPWT application|NPWT mode is cyclic mode : -125~-50 mmHg
16084694|NCT02274194|Device|Nasal CPAP|use of nasal mask to titrate CPAP during a manual full night: if nasal mask is the best interface during titration compared with oronasal mask - patients will go 30-day period of treatment
16084695|NCT02274194|Device|Oronasal CPAP|use of oronasal mask to titrate CPAP during a manual full night: if oronasal mask is the best interface during titration compared with nasal mask - patients will go 30-day period of treatment
16084696|NCT02274181|Drug|Androxal|
16084697|NCT02274168|Procedure|Conventional RF catheter ablation|RF catheter ablation will be performed as usually done by each center. No ICD EGMs will be obtained and used during the ablation procedure (do not place the programming head over the ICD generator).
16084698|NCT02274168|Procedure|Investigational RF Catheter Ablation using ICD-EG information|RF ablation procedure will be performed with the programming head over the ICD generator. ICD EGMs will be registered every time VT is induced and during ventricular pacing. ICD EGMs obtained during ablation procedure will be compared with the EGMs of the registered spontaneus VT and used to locate appropriate ablation sites.
16084699|NCT02274155|Drug|Anti-OX40 antibody administration|Anti-OX40 antibody administration at 0.4 mg/kg IV x 3 doses given on Days 1, 3 or 4, and 5 or 6 of study
16084700|NCT02274155|Procedure|Surgical Resection|Surgical Resection of Tumor
16084701|NCT02274142|Procedure|Restoration with hand-mixed material|restoration with hand-mixed glass ionomer cement
16084702|NCT02274142|Procedure|Restoration with Encapsulated material|restoration with encapsulated ionomer cement
16084703|NCT02274142|Device|Encapsulated glass ionomer cement (EQUIA - GC Corp).|
16084704|NCT02274142|Device|powder-liquid glass ionomer cement (Fuji IX - GC Corp)|
16084705|NCT02274129|Device|Healing cap II|Healing cap II is used instead of the traditional healing cap as part of the surgical dressing after bone anchored hearing aid implant surgery
16084706|NCT02274116|Other|SHAM - Intermittent Room Air - room air mixture|Participants will breathe intermittent room air via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of fraction of inspired oxygen (FIO2)=0.21±0.02 (normoxia). Participants will receive treatment 5 times per week for 2 weeks.
16084707|NCT02274116|Other|AIH - Intermittent Hypoxia - hypoxia air mixture|Participants will breathe intermittent low oxygen via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of fraction of inspired oxygen (FIO2)=0.10±0.02 (hypoxia). Participants will receive treatment 5 times per week for 2 weeks.
16084708|NCT02274103|Behavioral|BFST|Family-based skills training.
16084709|NCT02274090|Drug|Placebo gel|Placebo gel consist of drug without the active component.
16084710|NCT02274090|Drug|1% Metformin gel|Metformin gel consist of active component.
16084711|NCT02274077|Drug|EXPAREL|
16084712|NCT02274077|Drug|Normal Saline|
16084713|NCT02274064|Behavioral|Motivational Interview and Implementation Intention|Telephone call that includes motivational interviewing techniques and develops an implementation intention plan.
16084714|NCT02274051|Dietary Supplement|Kinetin|Titration of Kinetin to maximum individualized dose, then steady state over a 3 year period once daily dose.
16084715|NCT02274038|Drug|Baseline 18F-thymidine (FLT) PET/CT|FLT is a fluoro-labelled thymidine analog used as a radiotracer of tumor proliferation in PET/CT imaging. This baseline scan will be used to compare post-therapy FLT-PET/CT in order to assess change in tumor accumulation of FLT.
16084814|NCT02273336|Other|cytology specimen collection procedure|Undergo tissue and blood sample collection
16084716|NCT02274038|Drug|"Post-therapy 18F-thymidine (FLT) PET/CT to assess for pemetrexed induced tumor FLT flare"|"FLT is a fluoro-labelled thymidine analog used as a radiotracer of tumor proliferation in PET/CT imaging. This scan will be performed on the day of starting pemetrexed therapy (within 24hrs of starting pemetrexed) and used to compare to baseline FLT-PET/CT in order to assess change in tumor accumulation of FLT. The objective is to assess for early pemetrexed induced changes in tumor accumulation of FLT known as FLT flare."
16084717|NCT02274038|Drug|Post-therapy 18F-thymidine (FLT) PET/CT to assess for pemetrexed induced changes in tumor proliferation|FLT is a fluoro-labelled thymidine analog used as a radiotracer of tumor proliferation in PET/CT imaging. This scan will be performed 2-4 weeks after starting pemetrexed therapy and used to compare to baseline FLT-PET/CT in order to assess change in tumor accumulation of FLT. The objective is to assess for pemetrexed induced changes in tumor accumulation of FLT as a surrogate measure of tumor proliferation.
16084718|NCT02274012|Drug|Afatinib|Afatinib 40mg/PO daily will be administered in combination to standard of care paclitaxel.
16084719|NCT02274012|Drug|Paclitaxel|On the day of the first dose of afatinib, paclitaxel will be administered at a dose of 80 mg/m2 intravenously over 60 minutes on days 1, 8 and 15 of a 28-day cycle.
16084720|NCT02273999|Device|RecoveryRx™|Appliance of the device after surgery
16084721|NCT02273986|Drug|Digoxin|
16084722|NCT02273986|Drug|K-877|
16084723|NCT02273973|Drug|Letrozole|Letrozole tablets will be administered orally at 2.5 mg QD for 16 weeks.
16084724|NCT02273973|Other|Placebo|Placebo tablets matched to taselisib formulation will be administered orally daily on 5 days-on/2 days-off schedule for up to 16 weeks.
16084725|NCT02273973|Drug|Taselisib|Taselisib will be administered orally at 4 mg (two 2 mg tablets) daily.
16084726|NCT02273960|Drug|BMS-986004 75 mg IV|BMS-986004 (75 mg) infusion (50 ml) administered in 120 minutes
16084727|NCT02273960|Drug|BMS-986004 225 mg IV|BMS-986004 (225 mg) infusion (100 ml) administered in 120 minutes
16084728|NCT02273960|Drug|BMS-986004 675 mg IV|BMS-986004 (675 mg) infusion (100 ml) administered in 120 minutes
16084729|NCT02273960|Drug|BMS-986004 1500 mg IV|BMS-986004 (1500 mg) infusion (100 ml) administered in 120 minutes
16084730|NCT02273947|Drug|BMS-955176|Single dose by mouth for each treatment specified
16084731|NCT02273934|Behavioral|Reablement|The intervention deals with improving function in daily activities the person defines as important in the areas of self-care, productivity and leisure.
16084732|NCT02273934|Behavioral|Standard treatment|The control intervention is standard home-based treatment/care in Norway.
16084733|NCT02273921|Other|EEG recording|EEG is recorded once for each participant
16084734|NCT02273908|Other|No intervention|The study is observational
16084735|NCT02273895|Drug|Scopolamine|0.3 mg/mL, intravenously, once
16084736|NCT02273843|Drug|High-dose vitamin D 3|Will receive oral cholecalciferol (vitamin D3) in a single daily dose of 800 IU from the time of diagnosis of sepsis until discharge from the NICU
16084737|NCT02273843|Drug|Conventional-Dose Vitamin D 3|Will receive oral cholecalciferol (vitamin D3) in a single daily dose of 400 IU from the time of diagnosis of sepsis until discharge from the NICU
16084738|NCT02273830|Drug|oxygen|Oxygen administered after adjustment during a waking test or at 3L/min
16084739|NCT02273817|Drug|Ciclesonide nasal spray, 50 μg per actuation.|"During placebo lead-in period: patients received placebo nasal spray, two actuations in each nostril once daily for 7 days.
~During treatment period: subjects were then assigned to one of the following three treatments according to the randomization scheme:
~Ciclesonide nasal spray: 50 μg per actuation, two actuations in each nostril once daily (200 μg per day) for 14 days.
~Omnaris™ nasal spray: 50 μg per actuation, two actuations in each nostril once daily (200 μg per day) for 14 days.
~Placebo nasal spray: 0 μg per actuation, two actuations in each nostril once daily for 14 days."
16084740|NCT02273804|Drug|Topiramate|Topiramate for 9 months treatment, and then 27 months of follow-up Dose regimen will be determined according to theoretical weight (taken orally), escalated every 15 days. Patients who do not tolerate dose escalation will be reduced to the highest tolerated dose.
16084741|NCT02273804|Drug|Placebo|Placebo will be taken orally following to the same dose regimen according to theoretical weight
16084742|NCT02273791|Drug|Estradiol valerate|Women will be given estradiol valerate 4 mg daily from day 2 to day 12 of the cycle then the endometrial thickness will be assessed on day 13 by transvaginal sonography (TVS). If the endometrium is ≥ 8 mm and of moderate echogenicity, luteal phase support (using progesterone supplements) will be started but if the endometrium is < 8 mm, estradiol valerate will be continued until reaching appropriate endometrial thickness and echogenicity then the luteal phase support will be started.
16084743|NCT02273791|Drug|Sequential Clomiphene citrate and Gonadotropin|Women will be given clomiphene citrate in dose of 100-150 mg daily for 5 days (from day 2 to day 6 of the cycle) then switched to low dose gonadotropin (75-150 IU daily) followed by monitoring of the follicular growth (folliculometry) ); starting from day 10 of the stimulation cycle and repeated every 2 days. Final oocyte maturation will be induced by administration of human chorionic gonadotropin (HCG) when there will be at least one leading follicle > 18 mm in diameter followed by luteal phase support (using progesterone supplements) after 48 hours.
16084744|NCT02273778|Procedure|MRI Scan|
16084745|NCT02273778|Procedure|PET-CT Scan|
16084746|NCT02273778|Other|No intervention|
16084747|NCT02273765|Drug|Tenofovir + lamivudine + raltegravir|"In this arm, patients will receive the following medications :
~Tenofovir disoproxil fumarate (TDF) 300 mg / Lamivudine (3TC) 300 mg FDC once a day (1 tablet qd)
~Raltegravir (RAL) 400 mg (Isentress®): twice daily (1 tablet bid), with food
~In countries where TDF/3TC FDC is not available, the following separate drugs will be used:
~Tenofovir disoproxil fumarate (TDF) 300 mg (Viread® 245 mg): once a day (1 tablet qd)
~Lamivudine (3TC) : 300 mg once a day (300 mg, 1 tablet qd or 150 mg 2 tablets qd)
~Raltegravir (RAL) 400 mg (Insentress®): twice daily (1 tablet bid), with food"
16084815|NCT02273336|Other|laboratory biomarker analysis|Correlative studies
16084816|NCT02273323|Other|Tea|Single dose of black tea infusion containing approximately 400 mg flavonoids (expressed as gallic acid equivalents) with added sugar.
16084817|NCT02273323|Other|Placebo|Placebo: tea flavour, colouring and sugar
16084818|NCT02273310|Behavioral|Problem-Solving Skills Training for Disease Management|Children and caregivers participated in a multi-family group to learn problem-solving skills as applied to disease management and school functioning in the context of sickle cell disease.
16084748|NCT02273765|Drug|Tenofovir + lamivudine + efavirenz|"In this arm, patients will receive the following medications, in accordance with treatment guidelines in all countries:
~Tenofovir disoproxil fumarate (TDF) 300 mg / lamivudine (3TC) 300 mg FDC once a day (1 tablet qd)
~Efavirenz (EFV) 600 mg: once a day, at night (1 tablet qd)
~OR:
~• Tenofovir disoproxil fumarate (TDF) 245 300 mg / lamivudine (3TC) 300 mg / efavirenz (EFV) 600 mg: once a day (1 tablet qd), at night, if possible without food
~In countries where TDF/3TC FDC is not available, the following separate drugs will be used:
~Tenofovir disoproxil fumarate (TDF) 300 mg (Viread® 245 mg): once a day (1 tablet qd)
~Lamivudine (3TC): 300 mg once a day (300 mg, 1 tablet qd or 150 mg 2 tablets qd)
~Efavirenz (EFV) 600 mg: once a day, at night (1 tablet qd), if possible without food. The dose will not be adapted to the patient's body weight."
16084749|NCT02273752|Drug|Everolimus|Given PO
16084750|NCT02273739|Drug|Enasidenib|Enasidenib tablets administered orally once a day in 28-day treatment cycles until disease progression or unacceptable toxicities.
16084753|NCT02273713|Drug|Nab-paclitaxel|Nab-paclitaxel added to first line treatment oxaliplatin and capecitabine
16084754|NCT02273700|Drug|Rivaroxaban|Patients are observed during their first month of Rivaroxaban (Xarelto®) treatment, which is part of their routine care.
16084755|NCT02273687|Device|Vivid S6 GE Ultrasound|"Diaphragmatic ultrasound will be performed by the physician supporting the patient on arrival and also at 4 hours later in the beginning of therapeutic management. The patient will be monitored for 24 hours following inclusion.
~The exams will all be done with the same ultrasound system (Vivid S6 GE Ultrasound) and a phased array probe, also called a cardiac probe."
16084756|NCT02273674|Device|Left rTMS 5 Hz|The subjects will receive transcranial magnetic stimulation (5 Hz of frequency over left dorsolateral prefrontal cortex . Once a day on monday to friday. Until receive 15 sessions. After this the subjects, will be received 8 more sessions of TMS, one session at week for next eight weeks
16084757|NCT02273674|Device|Right r TMS 1 Hz|The subjects will receive transcranial magnetic stimulation (1 Hz of frequency over right dorsolateral prefrontal cortex . Once a day on monday to friday. Until receive 15 sessions. After this the subjects, will be received 8 more sessions of TMS, one session at week for next eight weeks
16084758|NCT02273661|Drug|Liposomal amphotericin B (Ambisome®)|An aerosol of Liposomal Amphotericin B (Ambisome®) at 25 mg x 1/ week will be administered during 6 months
16084759|NCT02273661|Drug|placebo|An aerosol of isotonic saline x 1/ week will be administered during 6 months
16084760|NCT02273648|Device|Drug Eluting Stent (DES)|Percutaneous Coronary Intervention
16084761|NCT02273635|Drug|Andrographolides|140 mg andrographolides coated tablets twice a day orally administered for 24 months.
16084762|NCT02273635|Drug|placebo|140 mg excipients coated tablets twice a day orally administered for 24 months
16084763|NCT02273622|Dietary Supplement|hydroxytyrosol|Pilot study with 20 participants, each participant will alternately by the two arms of the study (hydroxytyrosol 5 mg and 20 mg) and control, during 6 weeks.
16084764|NCT02273622|Dietary Supplement|placebo|
16084765|NCT02273609|Drug|Vitamin K antagonists (acenocoumarol or warfarin)|"INR values of patients treated with acenocoumarol or warfarin in the last 12 months will be recorded according to clinical practice of each center.
~No specific recommendation about treatment will be provided by sponsor."
16084766|NCT02273596|Drug|ALXN1840|Individualized oral doses of ALXN1840.
16084767|NCT02273583|Drug|continuous oral cyclophosphamide and methotrexate|
16084768|NCT02273570|Drug|standard care|Standard care. Patients allocated to this study arm will be treated with all drugs available for PTH control (at the investigator discretion) to obtain a iPTH of 300-540 pg/ml.
16084769|NCT02273570|Drug|Optimal (I. iPTH control: Zemplar®,Mimpara®; phosphorous control: Renvela®, Phoslo®, Osvaren®, Foznol®,Maalox®; calcium control: calcium and vitamin D|Optimal care. Patients allocated to this study arm will be treated with all drugs available for PTH control (at the investigator discretion - see therapeutic algorithm) to obtain a iPTH of less than 300 pg/ml.
16084770|NCT02273557|Drug|Asasantin ER (new formulation I - low)|
16084771|NCT02273557|Drug|Asasantin ER (new formulation III - medium)|
16084772|NCT02273557|Drug|Asasantin ER (new formulation II - high)|
16084773|NCT02273557|Drug|Asasantin ER (present commercial formulation)|
16084774|NCT02273544|Drug|Asasantin ER (new formulation - low)|
16084775|NCT02273544|Drug|Asasantin ER (new formulation - medium)|
16084776|NCT02273544|Drug|Asasantin ER (new formulation - high)|
16084777|NCT02273544|Drug|Asasantin ER - commercial formulation|
16084778|NCT02273531|Drug|Asasantin ER, new formulation|
16084779|NCT02273531|Drug|Asasantin ER, present commercial formulation|
16084780|NCT02273518|Drug|Asasantin ER, new formulation I|
16084781|NCT02273518|Drug|Asasantin ER, new formulation II|
16084782|NCT02273518|Drug|Asasantin ER, present commercial formulation|
16084783|NCT02273505|Drug|Asasantin (ER)|
16084784|NCT02273505|Drug|Persantin|
16084785|NCT02273505|Drug|Acetyl salicylic acid (ASA)|
16084786|NCT02273492|Drug|Asasantin ER|
16084787|NCT02273492|Other|Standardized breakfast|
16084788|NCT02273479|Drug|Asasantin®|Asasantin® extended release (RAD-SP)
16084789|NCT02273479|Drug|Placebo|
16084790|NCT02273466|Drug|Desipramine tablet|
16084791|NCT02273466|Drug|Crobenetine infusion|
16084792|NCT02273466|Drug|Placebo infusion|
16084793|NCT02273453|Drug|Songha® Night|
16084794|NCT02273453|Drug|Oxazepam|
16084795|NCT02273453|Drug|Placebo|
16084796|NCT02273440|Drug|BIIL 284 BS|
16084797|NCT02273440|Drug|Theophylline|
16084798|NCT02273440|Drug|Placebo|
16084799|NCT02273427|Drug|BIIL 284 BS|
16084800|NCT02273427|Other|high fat meal|
16084801|NCT02273427|Other|low fat meal|
16084802|NCT02273414|Drug|BIIL 284 BS - rising dose|
16084803|NCT02273414|Drug|Placebo|
16084804|NCT02273401|Drug|BI 11054 CL|
16084805|NCT02273401|Drug|Placebo|
16084806|NCT02273388|Drug|BI 6727|
16084807|NCT02273375|Drug|MEDI4736|
16084820|NCT02273284|Device|Buzzy|The Buzzy will be applied for 30 seconds over the area that is going to be injected, then during the actual injection the Buzzy will be moved rostrally and continuously used during the injection. When the injection is completed the Buzzy is positioned in the same way over the next injection site.
16084821|NCT02273271|Other|18F-FLT-PET/CT and DWI-MRI|Patients with NSCLC will undergo 18F-FLT-PET/CT and DWI-MRI scans on three separate occasions. Dedicated in-house developed software will be used to quantify 18F-FLT SUV and ADC to assess tumor characteristics and response to therapy.
16084822|NCT02273258|Drug|SAR342434|Pharmaceutical form:solution Route of administration: subcutaneous
16084823|NCT02273258|Drug|Insulin Lispro|Pharmaceutical form:solution Route of administration: subcutaneous
16084824|NCT02273258|Drug|Insulin Lispro|Pharmaceutical form:solution Route of administration: subcutaneous
16084825|NCT02273245|Radiation|Thoracic aortogram CT|With and without contrast dye
16084826|NCT02273232|Other|Remote Ischemic Preconditioning|Blood pressure cuff will be inflated to 200 mmhg for 5 minuets and release for 5 minuets to total of 4 cycles
16084827|NCT02273232|Other|Supervised Exercise|constructed extra excessive for peripheral vascular diastase patients
16084828|NCT02273232|Other|Standard Care|Standard Care for peripheral vascular disease patients including advises regarding exercises
16084829|NCT02273219|Drug|AEB071|Oral, 100-400 mg twice daily A potent, oral, selective inhibitor of the classical Protein Kinase C (PKC)
16084830|NCT02273219|Drug|BYL719|Oral, 200-350 mg daily An oral class I α-specific PI3K inhibitor belonging to the 2-aminothiazole class of compounds
16084831|NCT02273206|Behavioral|Prevention Care Management for Depression and Cancer Screening|
16084832|NCT02273206|Behavioral|Prevention Care Management for Cancer Screening|
16084833|NCT02273180|Drug|SAR342434|SAR342434 100 U/mL (dose range of 1 Unit to 80 Units) self-administered by deep subcutaneous (SC) injection, immediately (within 5-10 minutes) before meal intake. Dose adjusted to achieve a 2-hour post prandial plasma glucose (PPG) in range of 6.7 to 8.9 mmol/L (120 to 160 mg/dL) while avoiding hypoglycemia.
16084834|NCT02273180|Drug|Humalog|Humalog 100 U/mL (dose range of 1 unit to 60 units) self-administered by deep SC injection, immediately (within 5-10 minutes) before meal intake. Dose adjusted to achieve a 2 hour PPG in range of 6.7 to 8.9 mmol/L (120 to 160 mg/dL) while avoiding hypoglycaemia.
16084835|NCT02273180|Drug|Insulin glargine HOE901|Insulin glargine 100 U/mL injected QD subcutaneously consistent with the local label. Doses adjusted to achieve glycemic target for fasting, preprandial plasma glucose (SMPG) between 4.4 to 7.2 mmol/L (80 to 130 mg/dL) without hypoglycemia.
16084836|NCT02273167|Drug|NER1006, 2-Day Split-Dosing|The subject will self-administer the first dose of the assigned investigational product in the evening prior to the scheduled colonoscopy and take mandatory additional clear fluid. Subject will take the second dose together with mandatory additional clear fluids on the morning of the colonoscopy.
16084837|NCT02273167|Drug|NER1006,1-Day Morning Split-Dosing|"The subject will self-administer the first dose of the investigational product on the morning of the colonoscopy and take mandatory additional clear fluid.
~After a 1-2 hour break the subject will self-administer the second dose plus additional clear mandatory fluid."
16084838|NCT02273167|Drug|MOVIPREP, 2-Day Split-Dosing|The subject will self-administer the first dose of the assigned investigational product in the evening prior to the scheduled colonoscopy and take recommended additional clear fluid. Subject will take the second dose together with recommended additional clear fluids on the morning of the colonoscopy.
16084839|NCT02273154|Drug|Buspirone|MDD patients with anxiety disorder take paroxetine (20-60mg/d), combining with buspirone (initial dose is 5mg tid, then increase the dose to 10mg tid on 4th day)
16084840|NCT02273154|Drug|Paroxetine|MDD patients with anxiety disorder take paroxetine (20-60mg/d)
16084841|NCT02273141|Drug|NER1006, Day Before-Only Dosing|The subject will self-administer both doses of NER1006 in the evening of Day 1 with 1-2 hours interval. Subject will take mandatory additional clear fluid after each dose.
16084842|NCT02273141|Drug|SP+MS, Day Before-Only Dosing|The subject will self-administer SP+MS in the morning of Day 1 and afternoon of Day 1. Subject will take mandatory additional clear fluid after each dose.
16084843|NCT02273128|Genetic|CTR Gene|2ml blood sample collected from patients to extract DNA for Assessment of CTR Gene polymorphism
16084844|NCT02273115|Drug|Oxytocin|
16084845|NCT02273115|Device|Transcervical Foley catheter|
16084846|NCT02273102|Drug|Tranylcypromine|Tranylcypromine (TCP) to be administered orally twice a day (12 hours apart) for up to 16 cycles of 21 days each.
16084847|NCT02273102|Drug|Tretinoin|45 mg/m2 of ATRA to be administered orally twice a day (12 hours apart), beginning on day 4 for up to 16 cycles of 21 days each.
16084848|NCT02273089|Device|CPAP (ResMed S9 AutoSet)|nocturnal CPAP for three months
16084849|NCT02273076|Device|Spatial Frequency Domain Imaging|Spatial Frequency Domain Imaging
16084850|NCT02273063|Device|Transcranial Magnetic Stimulation (TMS)|Up to 40 sessions of TMS delivered with the first 35 sessions delivered over 7 weeks, and final 5 treatments delivered in taper schedule over 3 weeks. Treatment is adjunct to ongoing stable pharmacotherapy.
16084851|NCT02273050|Drug|Saxagliptin 5 mg|Tablet, Oral, 5 mg, Once daily in the morning
16084852|NCT02273050|Drug|Placebo 5 mg for Saxagliptin|Tablet, Oral, 5 mg, Once daily in the morning
16084853|NCT02273050|Drug|Placebo 500 mg for metformin (with titration)|Tablet, 500 mg, Once daily in the evening the first two weeks and thereafter according to titration.
16084854|NCT02273050|Drug|Metformin 500 mg with titration|Tablet, 500 mg, Once daily in the evening the first two weeks and thereafter according to titration.
16084855|NCT02273037|Device|Fetal heart rate Doppler|A wind-up, handheld fetal heart rate monitor Doppler developed by Power-free Education Technology Doppler (www.pet.org.za)
16084856|NCT02273037|Procedure|Partograph|Graphical documentation of labour progress, and maternal and fetal well-being.
16084857|NCT02273024|Behavioral|Exercise|
16084858|NCT02273011|Procedure|caesarean section|elective caesarean section under regional anesthesia
16084859|NCT02272998|Drug|ponatinib hydrochloride|Given PO
16084860|NCT02272998|Other|laboratory biomarker analysis|Correlative studies
16084861|NCT02272985|Other|[15O]H2O PET-CT scan|All participants will undergo 3 [15O]H2O PET-CT scans during the hemodialysis study session
16084985|NCT02272127|Drug|icotinib|
16084863|NCT02272972|Other|Application of knowledge|Educational Intervention has been performed at the treating surgeon (video and poster). The surgeons applies the achieved knowledge when performing the intraoperative fluoroscopy in patients with pertrochanteric fractures.
16084864|NCT02272959|Behavioral|Attention bias modification treatment (ABMT)|Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns using threat and neutral stimuli.
16084865|NCT02272959|Behavioral|Attention Control Condition|Attention training using a computerized spatial attention task (dot-probe) not intended to alter threat-related attention patterns using only neutral stimuli.
16084866|NCT02272946|Drug|Canakinumab|150mg Canakinumab received subcutaneously
16084867|NCT02272946|Drug|Placebo|150mg Placebo received subcutaneously
16084868|NCT02272933|Device|Smart Slipper|The shoe measures foot pressure and motion allowing gait to be quantified.
16084869|NCT02272933|Device|Belt-Clip Sensor|The sensor measures acceleration of the body allowing falls to be detected.
16084870|NCT02272920|Procedure|Renal denervation|Medtronic Symplicity Flex, Medtronic Symplicity Spyral, or St Jude EnligHTN.
16084871|NCT02272907|Other|Injection of saline solution into specimen to test bursting pressure.|A 1 cm gastrotomy will be made with a purse-string suture placed around the defect. A fluid-instillation catheter will be inserted into the specimen via the gastrotomy. The purse-string suture will then be secured around the catheter. The catheter will be fenestrated with a flange to prevent leakage from the gastrotomy site. The catheter will be attached to a Biopac pressure-monitoring device to monitor pressure within the lumen of the specimen. The specimen will then be suspended in a water bath and methylene blue saline solution will be injected into the specimen to a pressure reading of 0. This will be time zero for our experiment. Methylene blue saline solution will then be injected steadily in incremental levels. During this process, the study team will observe for any obvious blue dye leaks at the staple line or drop in pressure on the monitor.
16084872|NCT02272894|Procedure|Dissection of the Superior Mesenteric Vein Lymph Node|14v lymph node dissection
16084873|NCT02272881|Procedure|surgical reconstruction|Patients randomized to surgical flap closure will undergo reconstructive plastic surgery to close an intended pressure ulcer at the earliest date after selection. Our group's co-investigator and staff plastic and reconstructive surgeon will decide on the optimal technical repair. Given the lack of retrospective evidence to support a superior surgical repair (myocutaneous, fasciocutaneous, local flap arrangement versus free microvascular tissue transfer) we will defer to our physician staff preference on a per patient basis. The time from enrollment to surgical intervention will be tracked, and no patient will be dropped from the study should this time exceed the two-week ideal.
16084874|NCT02272881|Procedure|wound management|Patients selected to the supportive wound care arm will be managed by the Center for Wound Care at Cottage Health System, a certified wound care center. They will receive standard of care conservative wound care including: debridement, dressing changes, wound checks, physical therapy, occupational therapy, antibiotic treatment, nutritional support and close follow-up over the study period.
16084875|NCT02272868|Biological|Fecal Microbial transplant|Pretransplant regimen(rifaxamin+omeprazole+miralax) + Donor feces transplant
16084876|NCT02272868|Drug|Normal Saline|Pretransplant regimen(rifaximin+omeprazole+miralax) +Normal Saline
16084877|NCT02272868|Drug|rifaximin+omeprazole+miralax|
16084878|NCT02272855|Biological|HF10 plus Ipilimumab|Patients will receive the dose of 1 x 10^7 TCID50/mL HF10 (for a total of 6 injections; the first 4 injections at 1-week intervals; the remaining 2 injections at 3-week intervals) and ipilimumab at 3 mg/kg ipilimumab (for a total of 4 intravenous infusions, each administered at 3-week intervals).
16084879|NCT02272842|Dietary Supplement|Vitamin B12|Vitamin B12 in a multivitamin paste.
16084880|NCT02272829|Behavioral|Choacot: Behavioral Intervention for Chronic Opioid Use|This is an intervention for individuals who use opioid medication for chronic pain, and targets the collaboration between the participant and his/her PCP.
16084881|NCT02272829|Other|Health Education|
16084882|NCT02272816|Drug|Carboplatin AUC-10|Carboplatin AUC-10 according to the Calvert formula [10 x (glomerular filtration rate (ml/min) + 25)]mg given in 5% glucose over 1 hour every 21 days for 3 or 4 cycles.
16084883|NCT02272803|Drug|Lenalidomide|
16084884|NCT02272803|Drug|Dexamethasone|
16084885|NCT02272803|Biological|Elotuzumab (BMS-901608)|
16084886|NCT02272790|Drug|Adavosertib|Adavosertib will be taken as oral capsules with water, approx. 2 hours before or 2 hours after food.
16084887|NCT02272790|Drug|Paclitaxel|"Paclitaxel will be administered as a 1-hour IV infusion (± 10 minutes) at a dose of 80 mg/m2 according to institutional standards on Days 1, 8, and 15 of each 28 Day cycle.
~Patients should be pre-medicated with corticosteroids, diphenhydramine and/or H2 antagonists according to institutional standards."
16084888|NCT02272790|Drug|Carboplatin|Carboplatin, at a dose calculated to produce an AUC of 5 will be administered by intravenous infusion according to institutional standards on Day 1 of each 21 Day cycle. The carboplatin dose will be calculated using the Calvert Formula based on the patient's glomerular filtration rate (GFR) which is estimated by using the creatinine clearance.
16084889|NCT02272790|Drug|Gemcitabine|Gemcitabine 800 mg/m² will be administered IV on Days 1, 8, and 15 of each 28-Day cycle.
16084890|NCT02272790|Drug|PLD|PLD (pegylated liposomal doxorubicin) 40 mg/m² IV will be given on Day 1 of each 28-Day cycle.
16084891|NCT02272777|Drug|Imatinib|Imatinib 400mg QD，300mg QD or 600mg QD
16084892|NCT02272777|Drug|Nilotinib|Nilotinib 300mg BID or 400mg QD
16084893|NCT02272764|Drug|Itraconazole|Administered orally in a crossover design
16084894|NCT02272764|Drug|ALKS 5461|Administered sublingually in a crossover design
16084895|NCT02272751|Behavioral|Exercise|The Exercise intervention will consist of aerobic activity followed by upper and lower limb resistance training using Therabands and some core exercises.
16084896|NCT02272751|Behavioral|Relaxation|The Relaxation intervention will consist of a chair-based program incorporating breathing exercises, meditation, visualisation and progressive muscle relaxation.
16084897|NCT02272738|Drug|Gemcitabine|Gemcitabine is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks.
16084898|NCT02272738|Drug|Nab-Paclitaxel|Nab-Paclitaxel is administered with 30 min intravenous infusion on day 1,8 and 15 every 4 weeks.
16084899|NCT02272725|Drug|Ibuprofen|Ibuprofen
16085029|NCT02271815|Other|Oral Hygiene|Oral Hygiene
16084901|NCT02272712|Behavioral|Cognitive Behavioural Therapy|psychoeducation about insomnia, relaxation training, sleep restriction, stimulus control, hypnotic tapering under direction of a physician, cognitive therapy, sleep hygiene
16084902|NCT02272699|Drug|Nimotuzumab|Nimotuzumab 200mg per week for 6 weeks.
16084903|NCT02272699|Drug|Paclitaxel|Paclitaxel 175mg per square metre on day 1, repeated every 3 weeks for 2 cycles.
16084904|NCT02272699|Drug|Cisplatin|Cisplatin 30mg per square metre on day 1 and day 2, repeated every 3 weeks for 2 cycles.
16084905|NCT02272699|Radiation|Radiation|IMRT of primary tumor and local lymph nodes with 95% PTV of 41.4 Gy/23f. Nimotuzumab 200mg per week for 6 weeks.
16084906|NCT02272699|Procedure|Surgery|Esophagectomy
16084907|NCT02272686|Drug|Ibrutinib|560 mg by mouth daily.
16084908|NCT02272673|Dietary Supplement|Honey|The subjects in the I/C group consumed 2 ml (2.5 g) honey/kg body weight/dose twice weekly in the first 12-week period (period 1), while the subjects in the C/I group did not receive honey as a control in the period 1. After period 1, the subjects of each group exchanged their protocol for the following 12-week period (period 2).
16084909|NCT02272660|Drug|Parecoxib sodium|The patients in the parecoxib group received a single 40mg dose of parecoxib sodium 30 minutes before incision, 9:00 pm on the operation day as well as 9:00 am and 9:00 pm for the next two days after the operation, along with PCIA morphine.
16084910|NCT02272660|Drug|Normal saline injection|The patients in the control group received 2 mL normal saline injection 30 minutes before Normal saline injection incision, 9:00 pm on the operation day as well as 9:00 am and 9:00 pm for the next two days after the operation, along with PCIA morphine.
16084911|NCT02272647|Drug|IM Saline Placebo (0.25 ml)|
16084912|NCT02272647|Drug|IM Estradiol valerate (2.5 mg)|
16084913|NCT02272647|Drug|IM Saline Placebo (0.5 ml)|
16084914|NCT02272647|Drug|IM Estradiol valerate (5.0 mg)|
16084915|NCT02272647|Drug|Oral Micronized Progesterone|
16084916|NCT02272647|Drug|Oral Placebo|
16084917|NCT02272647|Drug|Ghrelin (0.3 ug/kg)|
16084918|NCT02272647|Drug|Medroxyprogesterone - Acetate|
16084919|NCT02272647|Drug|Oral Placebo|(in lieu of Medroxyprogesterone)
16084920|NCT02272634|Drug|YPL-001 80 mg|twice daily [BID]
16084921|NCT02272634|Drug|YPL-001 160 mg|twice daily [BID]
16084922|NCT02272634|Drug|Placebo|twice daily [BID]
16084923|NCT02272621|Procedure|Minimally invasive aortic valve replacement|
16084924|NCT02272621|Procedure|Full sternotomy aortic valve replacement|
16084925|NCT02272608|Other|Evaluation of Sleep Apnea Related Inflammation with CRP, ESR and Neutrophil toLymphocyte Ratio|CRP, ESR and Neutrophil toLymphocyte Ratio values of sleep apnea patients were evaluated with respect to apnea- hypopnea scores.
16084926|NCT02272595|Other|Treatment Based on Genetic Mutation|Participant's molecular profile shows that they have a gene mutation that may benefit from study drugs that are believed to target their gene mutation. Participant assigned to Arm A and will receive these targeted drugs.
16084927|NCT02272595|Other|Treatment Based on No Genetic Mutation|Participant's molecular profile shows that they do not have a gene mutation. Participant assigned to Arm B in which doctor chooses a therapy based on other studies rather than gene mutation.
16084928|NCT02272582|Device|SOMVC001 Vascular Conduit Solution|SV harvesting will be uniformly performed using an open or endoscopic vein harvesting technique. Once harvested, the SV will be divided into segments and these vein segments from each patient to be immersed in one of two blinded solutions: SOMVC001 or heparin dosed saline. The patients will then be randomized and SVG segment allocations will be defined and grafted to the assigned target regions.
16084929|NCT02272582|Other|Standard of care Heparin-dosed saline|SV harvesting will be uniformly performed using an open or endoscopic vein harvesting technique. Once harvested, the SV will be divided into segments and these vein segments from each patient to be immersed in one of two blinded solutions: SOMVC001 or heparin dosed saline. The patients will then be randomized and SVG segment allocations will be defined and grafted to the assigned target regions.
16084930|NCT02272569|Device|STARflo Glaucoma Implant|Implantation of the STARflo Glaucoma Implant following surgical technique described in European labelling. Procedure does not require the use of anti-fibrotic medications.
16084931|NCT02272556|Other|Brain MRS during hyperglycemic clamp|All patients will undergo brain MRS at baseline and following 2 and 4 hours of hyperglycemia using the clamp technique
16084932|NCT02272556|Other|Analysis of Metabolites in cerebrospinal fluid|All patients will have the option to undergo a lumbar puncture for analysis of metabolites in cerebrospinal fluid
16084933|NCT02272543|Dietary Supplement|Fish surimi peptide|
16084934|NCT02272517|Drug|Vortioxetine 10-20 mg|
16084935|NCT02272517|Drug|Escitalopram 10-20 mg|
16084936|NCT02272491|Device|ZrO2 (Straumann CARES)|"Straumann CARES Variobase Abutment RN
~Straumann CARES Full Contour Zerion HT The monolithic zircona crown (2) will be bonded to the titanium base (1)"
16084937|NCT02272491|Device|PFM crown (Straumann Gold)|Porcelain-fused-to-metal crown consisting of a gold abutment, a gold core, and veneering ceramic
16084938|NCT02272478|Drug|Arm A Mylotarg plus DA Versus CPX-351|Patients not known to have adverse risk cytogenetics will enter a randomisation comparing DA with Mylotarg (GO) delivered at 3mg/m2 on day 1 of chemotherapy, with CPX-351 on days 1, 3 and 5.
16084939|NCT02272478|Drug|Arm B Vosaroxin and Decitabine|If a patient is known to have adverse risk Cytogenetics at diagnosis they will enter a registration to receive up to 5 courses of Vosaroxin and Decitabine.
16084940|NCT02272478|Drug|Arm D Small molecule or Not|The randomisation to AC220 or not will take place immediately before course 2 of treatment for patients who have received DA induction +/- Mylotarg, irrespective of residual disease status. Patients allocated to receive AC220 will be randomised in a 1:1 fashion to AC220 or no small molecule with a 1:1 randomisation in patients drawing AC220 between short and long therapy.
16084941|NCT02272478|Drug|Arm C DA V FLAG-Ida V DAC|If a patient is not in CR or CRi after course 1 or is MRD +ve/unknown by flow cytometry they will be eligible to be randomised in a 1:1:1 fashion between DA, FLAG-Ida (or mini FLAG-Ida if 70 years or older) and DAC.
16084942|NCT02272478|Drug|Arm E CPX-351 (200 V 300)|If a patient is not in CR or CRi after course 1 or is MRD +ve/unknown by flow cytometry they will be eligible to be randomised in a 1:1 fashion between CPX given on days 1, 3 and 5 (3 doses) and CPX given on days 1 and 3 (2 doses).
16085112|NCT02271217|Drug|dalfampridine-ER 7.5mg|
16084943|NCT02272478|Drug|Arm F DA V IDAC|Following recovery from course 2, patients in the MRD-ve arm will be randomised between a further 5-day cycle of DA or a cycle of intermediate dose cytarabine (IDAC) as the third chemotherapy course.
16084944|NCT02272465|Other|No intervention|Observational study
16084945|NCT02272452|Device|High-Resolution Magic-Angle Spinning Nuclear Magnetic Resonance spectroscopy|
16084946|NCT02272426|Behavioral|CARET|Combined Aerobic and Resistance Exercise Training
16084947|NCT02272426|Behavioral|CTI|Cognitive Training Intervention
16084948|NCT02272426|Behavioral|Sham CARET|Sham Combined Aerobic and Resistance Exercise Training
16084949|NCT02272426|Behavioral|Sham CTI|Sham Cognitive Training Intervention
16084950|NCT02272413|Drug|BI 695502|
16084951|NCT02272413|Drug|Avastin|
16084952|NCT02272400|Other|IGRT for prone partial breast irradiation (PBI)|IGRT for prone partial breast irradiation (PBI): All patients will be treated prone with 6 Gy/fraction delivered in 5 fractions over a 1-week period for a total dose of 30 Gy. Simulation and treatment will be started within 50 days from surgery in order to maximize the chances of optimal lumpectomy cavity visualization on the planning and cone beam CT scans. All patients will be followed monthly for the first 90 days then q3 months for the first year, then yearly for the next 10 years.
16084953|NCT02272387|Dietary Supplement|Vitamin D3 (Cholecalciferol)|
16084954|NCT02272387|Other|Placebo|
16084955|NCT02272374|Procedure|AVF creation|
16084956|NCT02272374|Procedure|TCC placement|
16084957|NCT02272374|Procedure|AVG creation|
16084958|NCT02272361|Other|laparoscopic sacrocolpopexy|
16084959|NCT02272361|Other|vaginal mesh surgery|
16084960|NCT02272348|Other|Training course to functional insulin therapy|Carbohydrate counting, carbohydrate/insulin ratio, sensitivity to insulin factor
16084961|NCT02272348|Other|Usual diabetes management.|
16084962|NCT02272335|Behavioral|Group Sessions|"10 weekly sessions:
~CBSM - 10 consecutive weekly sessions (and consists of a roughly 30-minute relaxation component, 45-minute cognitive-behavioral stress management component, and a 15-minute break). Groups include an average of 4-9 women and a female African American interventionist. Participants in CBSM receive a workbook that summarizes the rationale for each module, techniques learned within each module, a short out-of-session exercise to practice and the content of the CW condition as well.
~CW/EE - roughly 90 minutes in duration. Each session focuses on an important aspect of recovery from breast cancer. Modules were derived from products in the public domain"
16084963|NCT02272322|Device|cystocele repair with biomesh soft prolaps and endofast reliant|
16084964|NCT02272309|Procedure|EEG and EP measurement|
16084965|NCT02272296|Device|jet injector|1 administration of insulin in a dose of 0.2 units per kg body weight subcutaneously in the abdomen, 1 empty administration
16084966|NCT02272296|Device|Conventional pen (NovoPen IV)|1 administration of insulin in a dose of 0.2 units per kg body weight subcutaneously in the abdomen, 1 empty administration
16084967|NCT02272283|Device|Percutaneous coronary intervention with Nobori biolimus-eluting stent implantation|The third-generation biodegradable polymer Nobori biolimus-eluting stent is implanted in all patients
16084968|NCT02272270|Drug|Minocycline with chemoradiation (temozolomide and radiation therapy)|Patients receive minocycline in conjunction with standard chemoradiation and then they receive minocycline with standard chemotherapy.
16084969|NCT02272257|Behavioral|Early Direct Access Physical Therapy|Physical Therapy management including Manual therapy, Exercise, and education including cognitive behavioral therapy.
16084970|NCT02272257|Behavioral|Physician management|Physician management including advice, medication, and referral to physical therapy or other provider.
16084971|NCT02272244|Behavioral|Decision Support & Navigation|
16084972|NCT02272244|Behavioral|Standard|
16084973|NCT02272218|Procedure|bariatric lap band surgery|The intervention in this study is laparoscopic gastric banding (LAGB) surgery as a treatment option for obese patients with pain from knee osteoarthritis (KOA) refractory to medical treatment
16084974|NCT02272205|Other|Retrospective analysis of records|
16084975|NCT02272192|Behavioral|Early Start Denver Model (ESDM)|The Early Start Denver Model (ESDM) is a comprehensive developmental and behavioral early intervention approach for children with autism, ages 12 to 48 months. The program encompasses a developmental curriculum that defines the skills to be taught at any given time and a set of teaching procedures based in applied behavioral analysis to deliver this content. The teaching format focuses on trained therapists delivering the intervention 1:1 by engaging reciprocally with children in typical toddler activities involving play or daily routines, adding additional structure for children who need it to progress well. Progress data is collected throughout each session and used to make decisions about teaching approaches.
16084976|NCT02272192|Behavioral|Early Intensive Behavioral Intervention (EIBI)|EIBI is a one-to-one instructional approach based in applied behavior analysis used to teach skills in a planned, controlled, and systematic manner. Each trial or teaching opportunity has a definite beginning and end, thus the descriptor discrete trial. Within DTT, the use of antecedents and consequences is carefully planned and implemented. Positive praise and/or tangible rewards are used to reinforce desired skills or behaviors. Trial by trial data collection is an important part of DTT and supports decision making by providing teachers/practitioners with information about beginning skill level, progress and challenges, skill acquisition and maintenance, and generalization of learned skills or behaviors.
16084977|NCT02272179|Behavioral|As Safe As Possible|The ASAP (As Safe As Possible) treatment is a brief, intensive intervention initiated during inpatient care and transitioning to outpatient care. The intervention focuses on 1) using motivational interviewing (MI) strategies throughout care; 2) developing a safety plan, including adapting the plan to an interactive safety plan phone app, Brite); and 3) using treatment modules to target specific risk factors that are selected based on individual need.
16084978|NCT02272179|Behavioral|Brite|Brite is a HIPAA-compliant mobile application designed to provide the participants with emotion regulation and distress tolerance skills, social support, and convenient access to safety plan resources via the patients' phone.
16084979|NCT02272179|Behavioral|Treatment as Usual|Participants received usual treatment for suicidal adolescents as they transition from inpatient hospitalization to outpatient therapy, which included a paper safety plan.
16084980|NCT02272166|Drug|propofol|
16084981|NCT02272166|Drug|Sevoflurane|
16084982|NCT02272153|Other|Egg refined grain|
16084986|NCT02272101|Dietary Supplement|Vitamin D versus placebo|Cross-over design
16084987|NCT02272088|Behavioral|physical activity-moderate|cross -over of moderate and intense physical activity
16084988|NCT02272088|Behavioral|Intense physical activity|cross -over of moderate and intense physical activity
16084989|NCT02272075|Device|Mobile OCT M3 scope|
16084990|NCT02272062|Other|Decision-making tool for coronary artery disease treatment|A brief internet-based tool will provide education about coronary artery disease and assess patient preferences regarding treatment options (medical management, percutaneous coronary intervention, or coronary artery bypass graft). This information will be provided to the treating interventional cardiologist at the time of coronary angiography in the treatment group.
16084991|NCT02272049|Drug|Hyperpolarized 129 Xenon|During the scans, subject will inhale hyperpolarized Xenon gas for up to 16 seconds per scan, for up to 4 separate MR scans
16084992|NCT02272036|Procedure|Colonoscopy|Colonoscopy is performed in both study arm as standard examination
16084993|NCT02272036|Device|mobile phone|SMS received by mobile phone
16084994|NCT02272023|Behavioral|Intensive Motivational Interviewing|Weekly individual therapy sessions over 9 weeks (Intensive MI condition) consisting of supportive and directive interventions. The control condition consists on a single session of MI and nutritional education.
16084995|NCT02272023|Behavioral|Single session of Motivational Interviewing|
16084996|NCT02272010|Other|Experimental Diet|Altered n-6 (linoleic acid) and n-3 (eicosapentaenic acid (EPA) + docosahexaenoic acid (DHA)) diet.
16084997|NCT02272010|Other|Comparator Diet|Diet standardized to the usual American distribution of n-6 (7%) and n-3 EPA+DHA (150 mg per day).
16084998|NCT02271997|Drug|Ferrous fumarate|treatment with ferrous fumarate during 1 year and 6,12,26 and 52 weeks after starting treatment iron spectrum will be measured
16084999|NCT02271997|Drug|Ferrous gluconate|treatment with ferrous gluconate during 1 year and 6,12,26 and 52 weeks after starting treatment iron spectrum will be measured
16085000|NCT02271997|Drug|Iron(III)carboxymaltose|treatment with Iron(III)carboxymaltose and 6,12,26 and 52 weeks after starting treatment iron spectrum will be measured
16085001|NCT02271984|Drug|MSC2499550A|Subjects will receive a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water under fed condition in one of the intervention periods. There will be a wash-out period of at least 7 days between each intervention period.
16085002|NCT02271984|Drug|Cysticide|Subjects will receive a single oral dose of current PZQ formulation (Cysticide®) at 40 mg/kg with water, under fed condition in one of the intervention periods. There will be a wash-out period of at least 7 days between each of the intervention period.
16085003|NCT02271984|Drug|MSC2499550A|Subjects will receive a single oral dose of MSC2499550A formulation at 10 mg/kg dispersed in water under fed condition in one of the intervention periods. There will be a wash-out period of at least 7 days between each of the intervention period.
16085004|NCT02271984|Drug|MSC2499550A|Subjects will receive a single oral dose of MSC2499550A formulation at 30 mg/kg dispersed in water under fed condition in one of the intervention periods. There will be a wash-out period of at least 7 days between each of the intervention period.
16085005|NCT02271984|Drug|MSC2499550A|Subjects will receive a single oral dose of MSC2499550A formulation at 20 mg/kg dispersed in water in fasted condition in one of the intervention periods. There will be a wash-out period of at least 7 days between each of the intervention period.
16085006|NCT02271984|Drug|MSC2499550A|Subjects will receive a single oral dose of MSC2499550A formulation at 20 mg/kg directly disintegrated in the mouth without water under fed conditions in one of the intervention periods. There will be a wash-out period of at least 7 days between each of the intervention period.
16085007|NCT02271971|Dietary Supplement|Vitamin D3|A daily 5.000 IU vitamin D3 capsule during 6 weeks.
16085008|NCT02271971|Dietary Supplement|Placebo|A daily placebo capsule during 6 weeks.
16085009|NCT02271958|Drug|Mifepristone|
16085010|NCT02271958|Drug|PLACEBO|
16085011|NCT02271945|Drug|MEDI-551 12 mg/kg|Participants will receive intravenous (IV) infusion of MEDI-551 12 mg/kg on Days 1 and 8 of Cycle 1 and Day 1 of Cycle 2 through Cycle 13
16085012|NCT02271945|Drug|MEDI0680 2.5 mg/kg|Participants will receive IV infusion of MEDI0680 2.5 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
16085013|NCT02271945|Drug|MEDI0680 10 mg/kg|Participants will receive IV infusion of MEDI0680 10 mg/kg on Days 2 and 15 of Cycle 1 and Days 1 and 15 of Cycle 2 through Cycle 13.
16085014|NCT02271932|Other|Non-operative|Patients will receive only antibiotics and will not undergo appendectomy unless they do not improve or their appendicitis recurs
16085015|NCT02271919|Drug|Nicotine Lozenge|Given PO
16085016|NCT02271919|Drug|Nicotine Patch|Given via patch
16085017|NCT02271919|Other|Placebo|Given PO or via patch
16085018|NCT02271919|Other|Tobacco Cessation Counseling|Receive behavioral smoking cessation counseling
16085019|NCT02271919|Drug|Varenicline|Given PO
16085020|NCT02271906|Drug|BIBW 2992|40 mg by mouth daily for a minimum of 14 days, and until the day of surgery.
16085021|NCT02271893|Drug|Dextromethorphan|The aim of this study is to assess if dextromethorphan administered during 4 weeks induces a decrease of pain intensity in breast cancer patients suffering from chemotherapy-induced peripheral neuropathy compared to placebo group.
16085022|NCT02271880|Other|Medication as usual|Physicians will prescribe medication as usual to the adolescent.
16085023|NCT02271880|Other|STAR|Adolescents and their parents will receive 6 sessions of psychosocial treatment to improve adolescents' motivation to use medication and to develop parent/teen contracting with the goal of setting medication adherence goals.
16085024|NCT02271867|Procedure|Interscalene block|An ultrasound guided ISB was performed with injection aimed to block the C5-root
16085025|NCT02271854|Drug|Diclofenac sodium gel 1%|Diclofenac sodium gel 1% four times daily (This study is a within-subject design i.e. active drug applied to one leg and placebo to the other leg at the same time. Therefore the study design is not a cross-over).
16085026|NCT02271854|Drug|Placebo|Placebo gel four times daily (This study is a within-subject design i.e. active drug applied to one leg and placebo to the other leg at the same time. Therefore the study design is not a cross-over).
16085027|NCT02271841|Device|PVI|Pleth Variability Index
16085028|NCT02271828|Procedure|Sentinel lymph node procedure|Sentinel lymph node procedure according to the Dutch breast cancer guideline
16085030|NCT02271802|Dietary Supplement|Sodium butyrate|Patients recieved an enema containing butyrate or a placebo during upper abdominal surgery.
16085031|NCT02271802|Dietary Supplement|NaCl|
16085032|NCT02271789|Other|problematic tooth|problematic tooth
16085033|NCT02271776|Dietary Supplement|Galactooligosaccharide|The dietary fiber GOS will be supplemented in powder form to regular daily food intake three times per day for 12 weeks
16085034|NCT02271776|Dietary Supplement|maltodextrin|
16085035|NCT02271763|Other|ultrasound|subjects' neck will be scanned using ultrasound
16085036|NCT02271750|Procedure|lumbar puncture|for spinal fluid
16085037|NCT02271737|Behavioral|Training HC/VHSG, Health Education, and Supportive Supervision|1. Improve infection control Practice at health centers; 2) improve knowledge on newborn danger signs among HC staff, VHSG, and the mothers; 3) improve care coordination between community and health facilities, e.g. improve referral of sick newborns
16085038|NCT02271724|Procedure|Lumbar puncture|Lumbar puncture for spinal fluid
16085039|NCT02271724|Procedure|Blood sample|Blood sample
16085040|NCT02271711|Other|Laboratory Biomarker Analysis|Correlative studies
16085041|NCT02271711|Biological|Natural Killer Cell Therapy|Given autologous ex-vivo expanded NK cells IV
16085042|NCT02271698|Drug|Dexamethasone|Intravenous dexamethasone at incision and 24h after incision will be compared in 3 doses and placebo administered in a fourth group
16085043|NCT02271698|Other|Placebo|Placebo injection of saline at surgical incision and a repeat placebo saline injection 24h after incision.
16085044|NCT02271685|Other|Instructions about Overestimates|Participants are told that overestimating the duration of sounds are associated with low disease risk.
16085045|NCT02271685|Other|Instructions about Parkinson's|Participants are told that the task is about risk of Parkinson's disease.
16085046|NCT02271685|Other|Instructions about Underestimates|Participants are told that underestimating the duration of sounds are associated with low disease risk.
16085047|NCT02271685|Other|Instructions about Alzheimers|Participants are told that the task is about risk of Alzheimers disease.
16085048|NCT02271672|Device|XP1000 RF|Treatment of adipose tissue within the fat layer with XP1000 RF.
16085049|NCT02271672|Device|sham XP1000 RF|Treatment of adipose tissue within the fat layer with XP1000 RF.
16085050|NCT02271659|Radiation|Brachytherapy boost with external beam radiotherapy|Bras A: External beam radiotherapy of 46 Gy delivered with a linear accelerator (Varian) to the prostate and the first centimeter of the seminal vesicles with a brachytherapy boost (of iodine-125 seeds from Bard (110Gy) or high dose rate (14Gy) with a iridium-192 source) only to the prostate. Each center will choose the appropriate brachytherapy technique. The number of seeds or needles will depend on the prostate's volume.
16085051|NCT02271659|Radiation|Exclusive external beam radiotherapy|Bras B: External beam radiotherapy of 46 Gy delivered with photons and a linear accelerator (Varian) to the prostate and the first centimeter of the seminal vesicles with an external beam radiotherapy of 80 Gy to the prostate alone.
16085052|NCT02271646|Drug|0.5% marcaine 20ml|3 levels ultrasound guided thoracic paravertebral block at T5-6, T7-8 and T9-10 (total 0.5% marcaine 20ml)
16085053|NCT02271633|Dietary Supplement|Sodium nitrate|
16085054|NCT02271633|Dietary Supplement|Beetroot juice|
16085055|NCT02271633|Dietary Supplement|Spinach|
16085056|NCT02271633|Dietary Supplement|Rocket salad|
16085057|NCT02271620|Procedure|nasal allergen provocation test|nasal allergen provocation test
16085058|NCT02271607|Device|moxibustion|The treatment schedule is three times per week for four weeks. Indirect moxa pillars and indirect-container moxibustion will be used.
16085059|NCT02271594|Behavioral|Intensive Training on Best Insulin Injection Technique|The intervention consists of instructing patients in whom LH is detected and who are currently injecting into it to move injections to non-LH areas; reducing insulin doses initially by 10-20% to avoid hypoglycaemia and then titrating to target control; instructing these patients to correctly rotate sites (leaving 1 cm between injection punctures and allowing used sites to heal for 2-4 weeks before injecting in them again); instructing these patients to forego needle reuse; and instructing these patients to switch to 4 mmx32G needles. A battery of tools (described below) will be used to deliver and reinforce this training, including frequent contact by phone or other electronic means after the initial training.
16085060|NCT02271594|Behavioral|Standard education on injection technique|Usual and customary education and training normally provided injecting patients at the center
16085061|NCT02271568|Procedure|Bariatric surgery|Laparoscopic or Robot R-Y gastric bypass
16085062|NCT02271568|Other|Intensive medical therapy|intensive medical therapy according to published guidelines by ADA and EASD
16085063|NCT02271555|Drug|Sevoflurane|Anesthetic induction will be achieved via 8% sevoflurane
16085064|NCT02271555|Drug|Remifentanil|After the loss of consciousness remifentanil will be administered to Group sevoflurane-remifentanil in the form of a 1 µg/kg intravenous bolus.
16085065|NCT02271555|Drug|Saline|After the loss of consciousness saline will be administered to Group sevoflurane-saline intravenous bolus.
16085066|NCT02271542|Drug|propofol|Propofol, 1-2 mg / kg after the installation is 100 to 200 mg / kg / min infusion for 30-60 minutes after application will be made and EDTA tubes with 2 ml blood sample will be taken. Determined from blood samples obtained by studying the polymorphism genotypes of patients will be exposed.
16085067|NCT02271529|Device|Zilver® PTX® Drug-Eluting Peripheral Stent|Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
16085068|NCT02271516|Radiation|188Re-BMEDA-liposome|EKG at baseline and in 24hours after administration
16085069|NCT02271503|Drug|CD-LD IR|CD-LD IR containing 25 mg carbidopa and 100 mg levodopa
16085070|NCT02271503|Drug|IPX203 180 mg|IPX203 containing 45 mg carbidopa and180 mg levodopa
16085071|NCT02271503|Drug|IPX203 270 mg|IPX203 containing 67.5 mg carbidopa and 270 mg levodopa
16085072|NCT02271503|Drug|Rytary 195 mg|Rytary 48.75Mg-195Mg Extended-Release Capsule
16085073|NCT02271503|Drug|Rytary 145 mg|Rytary 36.25Mg-145Mg Extended-Release Capsule
16085074|NCT02271490|Other|Acrosome Reaction induction|
16085075|NCT02271490|Other|capacitation in incubation medium prior to ICSI|
16085113|NCT02271217|Drug|dalfampridine-ER 10mg|
16085114|NCT02271204|Drug|Ibandronic acid|As prescribed by physician
16085076|NCT02271477|Device|Ultrasound-guided volemic repletion|After echocardiography analysis of Inferior Vena Cava, patient is repleted with a pre-established bolus of fluid (500 ml of crystalloid). After this repletion, patient is analyzed till the exam reach signal of non-responsiveness, previously defined as a reduction of Inferior Vena Cava diameter less than 36% from baseline level during normal breath
16085077|NCT02271464|Drug|Maintenance:BEVACIZUMAB|"Patients will be randomly assigned to receive induction chemotherapy with the G.O.N.O. FOLFOXIRI regimen plus bevacizumab:
~BEVACIZUMAB 5 mg/kg over 30 minutes, day 1
~IRINOTECAN 165 mg/sqm IV over 1-h, day 1
~OXALIPLATIN 85 mg/sqm IV over 2-h, day 1
~L-LEUCOVORIN 200 mg/sqm IV over 2-h, day 1
~5-FLUOROURACIL 3200 mg/sqm IV 48-h continuous infusion, starting on day 1
~with cycles repeated every 2 weeks for 4 months (8 cycles), followed after 2 weeks by (if no progression occurs):
~- BEVACIZUMAB 7.5 mg/kg over 30 minutes, day 1 (every three weeks)"
16085078|NCT02271464|Drug|Maintenance:BEVACIZUMAB+CAPECITABINE+CYCLOPHOSPHAMIDE|"Patients will be randomly assigned to receive induction chemotherapy with the G.O.N.O. FOLFOXIRI regimen plus bevacizumab:
~BEVACIZUMAB 5 mg/kg over 30 minutes, day 1
~IRINOTECAN 165 mg/sqm IV over 1-h, day 1
~OXALIPLATIN 85 mg/sqm IV over 2-h, day 1
~L-LEUCOVORIN 200 mg/sqm IV over 2-h, day 1
~5-FLUOROURACIL 3200 mg/sqm IV 48-h continuous infusion, starting on day 1
~with cycles repeated every 2 weeks for 4 months (8 cycles), followed after 2 weeks by (if no progression occurs):
~BEVACIZUMAB 7.5 mg/kg over 30 minutes, day 1 (every three weeks),
~CAPECITABINE 500 mg/tid orally, continuously,
~CYCLOPHOSPHAMIDE 50 mg/day orally, continuously."
16085079|NCT02271451|Device|Q collar|collar worn around neck
16085080|NCT02271438|Drug|Ibrutinib|Participants will receive a single oral dose of 12 capsules (12*140 mg capsules) of ibrutinib in Treatment A and 6 capsules (4 6*140 mg capsules) of ibrutinib in Treatment B.
16085081|NCT02271438|Drug|Moxifloxacin|Participants will receive a single oral dose of 1 moxifloxacin capsule (400 mg) in Treatment D.
16085082|NCT02271438|Drug|Ibrutinib-matching placebo|Participants will receive a single oral dose of 12 ibrutinib-matching placebo capsules in Treatment B and 6 ibrutinib-matching placebo capsules in Treatment C and D.
16085083|NCT02271438|Drug|Moxifloxacin-matching placebo|Participants will receive a single oral dose of 1 moxifloxacin-matching placebo capsule in Treatment A, B, and C.
16085084|NCT02271425|Drug|Evacetrapib Tablet|Oral administration
16085085|NCT02271425|Drug|Evacetrapib Intravenous|Intravenous administration
16085086|NCT02271412|Drug|LY03005|LY03005 is a new investigational pro-drug of desvenlafaxine formulated as extended-release oral tablets for the treatment of major depressive disorder.
16085087|NCT02271412|Drug|Placebo|Placebo
16085088|NCT02271399|Drug|acetylsalicylic acid|300 mg aspirin(acetylsalicylic acid, AA, Bayer)/day was given orally for 10 days postoperatively.
16085089|NCT02271399|Drug|rivaroxaban|xarelto 10mg(rivaroxaban, AA, Bayer)/day was given orally for 10 days postoperatively
16085090|NCT02271386|Behavioral|Supporting Practice for ADHD (SPA)|"The SPA intervention will last for 8 months for each study arm (first 8 months of the study for the intervention group, last 8 months for the control group). The intervention includes 3 components: 1) a series of web-based educational presentations to provide education to providers about evidence-based practice for managing ADHD and strategies for promoting effective communication with families 2) Collaborative consultation designed to address clinical issues arising in practice will be provided by members of the study team.
~3) Providers will be given systematic performance feedback with regard to their use of evidence-based practices for ADHD every 2 months during the 8-month intervention period."
16085091|NCT02271373|Behavioral|increasing time spent outdoors|The intervention group undertook interventions by increasing time spent outdoors. The interventions composed of performing two additional recess program lasting 30 minutes outside the classroom that encouraged children to go outside for outdoor activities during recess in both the morning and afternoon during school days within a intervention period of 1 school year.
16085092|NCT02271360|Drug|Calcium Dobesilate|1 cap / 8 hs Calcium Dobesilate ( 500mg) will be given at day of HCG injection and for 21 days
16085093|NCT02271360|Drug|Cabergoline|1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for 8 days
16085094|NCT02271347|Drug|CMX001|CMX001 administered as initial dose of 200mg then 100mg BIW for a total of 5 doses.
16085095|NCT02271334|Drug|A006 DPI|Single dose 110 mcg, 1 inhalation
16085096|NCT02271334|Drug|A006 DPI|Single dose 220 mcg, 1 inhalation
16085097|NCT02271334|Drug|Proventil® MDI|Single dose 90 mcg, 1 inhalation
16085098|NCT02271334|Drug|Proventil® MDI|Single dose 90 mcg, 2 inhalations
16085099|NCT02271321|Other|White noise|White noise is a simple, convenient, non-invasive and effective intervention. it sounds like the sound of running water, ocean or fan operation sounds. In this study, Subjects will receive 20 minute white noise of the ocean and the sound of running water at 16:00 to 17:00 for four weeks periods.
16085100|NCT02271308|Behavioral|Low-resistance elastic band training|The residents in experimental group will receive a low-resistance elastic band training (30 minutes), including warm-up and cold-down period, three times per week for 12 weeks.
16085101|NCT02271295|Drug|Enoxaparine|Enoxaparine 4000UI/day during 24 months
16085102|NCT02271282|Drug|Toremifene|
16085103|NCT02271282|Drug|Placebo|
16085104|NCT02271282|Drug|GHRH/Ghrelin combined Injection|
16085105|NCT02271269|Behavioral|Value Pricing Subsidies|"Usual care for glaucoma
~Subsidies granted to adherent patients for their glaucoma medications and physician visits, lowering the costs of treatment and providing a financial incentive for patients to take their medicines as prescribed.
~Subsidy (25 / 50%) granted based on meeting dose-rate adherence percentage targets (75 / 90%) at the month 3 and 6 assessment points."
16085106|NCT02271256|Device|Functional Intimate Apparel|The design of functional intimate apparel will incorporate different mechanisms, such as a) compression and pulling forces through a close fit of the intimate apparel, b) lumbar flexion by using a supporting belt, c) transverse forces applied by inserting pads inside the pocket lining with the application of 3-point pressure system, d) axial rotation or coupled motion by using uneven straps, and e) an active mechanism that aims to shift the trunk away from areas of pressure.
16085107|NCT02271230|Drug|Vitamin D and fish oil|2000 IU vitamin D and 1g/d fish oil
16085108|NCT02271230|Dietary Supplement|Fish oil (EPA/DHA) alone|1 g/d fish oil
16085109|NCT02271230|Drug|Vitamin D alone|2000 IU vitamin D
16085110|NCT02271230|Other|Placebo|Vitamin D placebo and fish oil placebo
16085111|NCT02271217|Drug|Placebo|
16085115|NCT02271191|Drug|Nicardipine|nicardipine 1-5 ug/kg/min and remifentanil 0.05 ug/kg/min during deliberate hypotension in spine surgery
16085116|NCT02271178|Other|Combined capsule|Combined capsule containing ramipril (5 to 10 mg), atenolol (50 to 100 mg), 100 mg aspirin, 40 mg simvastatin. In follow-up visits doses of atenolol and ramipril capsules may be adjusted according to blood pressure and heart rate.
16085117|NCT02271178|Other|Conventional therapy|Usual therapy
16085118|NCT02271165|Drug|Immunoglobulin (Hizentra)|
16085119|NCT02271152|Procedure|FAST mapping and ablation|
16085120|NCT02271152|Procedure|PVI|
16085121|NCT02271139|Drug|Alectinib|Alectinib 600 mg administered orally with food.
16085122|NCT02271126|Device|TEG monitoring|anticoagulation monitoring during ECMO will be according to TEG
16085123|NCT02271126|Device|APTT monitoring|anticoagulation monitoring during ECMO will be according to aPTT
16085124|NCT02271126|Drug|Heparin|Anticoagulation provided to patients in ECMO
16085125|NCT02271113|Drug|GMI-1271|
16085126|NCT02271113|Drug|Placebo|
16085127|NCT02271113|Drug|Enoxaparin Sodium (Lovenox®)|
16085128|NCT02271100|Device|ultrasound guidance|use of ultrasound for entry position estimation
16085129|NCT02271100|Device|palpation guidance|use of palpation for position estimation
16085130|NCT02271074|Other|Point of care CD4 testing|Participants in this arm will receive POC CD4 testing using the PIMA™ CD4 test system. Results will be made available to the participant within 20 to 25 minutes, before the participant leaves the HCT room. Participants will be given a copy of their results, which will be affixed to their referral letter, and they will be educated on the meaning of the CD4 results in relation to their health. This session will only be performed once at the time of issuing POC CD4 results.
16085131|NCT02271074|Behavioral|Care Facilitation|The goal of this intervention is to provide on-going counselling using a combination of motivational and strengths-based counselling approaches.This is a time limited intervention with a maximum of 5 client sessions over a 90-day period. Participants will also be transitioned out of the intervention upon successful entry into HIV care. Sessions will be done using both face-to-face and telephonic approaches, although the former is more preferred.
16085132|NCT02271074|Other|Transport support|The goal of this intervention is to address one of the most frequently noted structural barrier to entry-into-care in resource constrained settings: prohibitive distance or transport cost to reach a health facility.This is a time limited intervention with a maximum of 3 transport assists for healthcare visits over a 90-day period. Transport assistance is provided in the form of reimbursements to claims submitted by the participant after a self-reported HIV care clinic visits. Participants in this arm, receive their transport support through in-person collection or via cell phone transfer. Transport support amounts are standardised according to geographical area.
16085133|NCT02271061|Device|Kinesio tape|Elastic therapeutic tape is one type of elastic tape that is widely used for various treatment including rehabilitation and sports injuries . The elastic therapeutic tape has different characteristics from other kind of tape. It has ability to stretch around 130 - 140% from original length and recoil back to starting length after applying the tape. Tape produces pulling force on skin which lifts and folds layers of epidermis . Pulling force provides an appropriate alignment which can facilitate and inhibit muscle contraction.It has been claimed for several benefits such as supportingly injured muscles, increased proprioception, stimulated and inhibited muscle activity, relieved pain, increased range of motion, and improved blood and lymph flow.
16085134|NCT02271061|Device|Control tape|Apply tape in same technique without tension.
16085135|NCT02271048|Device|Remote ultrasonography interpretation using the smartphone|The reviewers interpreted the ultrasonography images on the smartphone transmitted from the ultrasound machine in real time
16085136|NCT02271035|Drug|Deflux|Deflux will be injected through the working channel of the cystoscope using a special needle into the submucosal space of the ureteral orifice (Deflux to one ureteral orifice and Vantris to the other side). The technique that will be used is HIT (Hydrodistention Implantation Technique)+ STING
16085137|NCT02271035|Drug|Vantris|vantris will be injected through the working channel of the cystoscope using a special needle into the submucosal space of the ureteral orifice (Deflux to one Vantris to the other side). The technique that will be used is HIT (Hydrodistention Implantation Technique)+ STING
16085138|NCT02271022|Other|Non-Interventional Study|Non-Interventional Study
16085139|NCT02271009|Drug|AllerT|Ultrafast immunotherapy
16085140|NCT02271009|Drug|Placebo|placebo control
16085141|NCT02270996|Other|Antimicrobial Stewardship Program|Twice weekly meeting with Infectious Disease and Pediatric Surgery team members to audit antibiotics prescribed and suggest role for discontinuation.
16085142|NCT02270983|Drug|Linaclotide 145 micrograms|
16085143|NCT02270983|Drug|Linaclotide 290 micrograms|
16085144|NCT02270983|Drug|Placebo|Matching placebo
16085145|NCT02270970|Biological|belimumab|belimumab will be given at 10 mg/kg intravenously at Week 1, Week 2, Week 4 and monthly after that as was done in Phase III trials and approved in the FDA label
16085146|NCT02270957|Biological|Abatacept|
16085147|NCT02270957|Other|Placebo|
16085148|NCT02270944|Biological|GBS Vaccine|Liquid formulation of a vaccine containing polysaccharide capsules from serotypes Ia, Ib, and III of the Group B Streptococcus
16085149|NCT02270944|Biological|GBS Vaccine|Lyophilized formulation of a vaccine containing polysaccharide capsules from serotypes Ia, Ib, and III of the Group B Streptococcus
16085150|NCT02270931|Device|CA 15-3 Assay|Physicians use the CA 15-3 test result to manage their patients
16085151|NCT02270918|Drug|Kcentra|IV infusion
16085152|NCT02270918|Drug|Apixaban|
16085153|NCT02270918|Drug|Placebo|
16085154|NCT02270905|Device|dCELL® Meniscus|decellularised porcine xenograft
16085155|NCT02270892|Device|Ulthera treatment|Focused ultrasound energy delivered below the surface of the skin
16085156|NCT02270879|Procedure|Phacoemulsification cataract surgery|Phacoemulsification of cataract (opacified lens) using clear corneal approach. Implantation of a intra-ocular lens in the capsular bag
16085157|NCT02270866|Device|TNM(trademark) - thermoneuromodulation|The device is worn like a music headset and the patient lies on a wedge pillow while the device is active. Each session lasts under 20 minutes.
16085158|NCT02270853|Device|sleep apnea screening with ApneaLinkTM|ApneaLink is sleep-screening tool that objectively identifies patients with sleep apnea
16085159|NCT02270840|Device|CRT-D|Biventricular upgrade. Subjects meeting the inclusion criteria (and if exclusion criteria are not present) patients will be randomized to CRT-D upgrade or ICD only (either continued ICD therapy in patients currently implanted with a defibrillator or implantation of a defibrillator in eligible patients who are currently implanted with pacemaker-only).
16085160|NCT02270827|Drug|Aminophylline|intravenous medication
16085161|NCT02270827|Drug|Hydrocortisone|Intravenous medication
16085162|NCT02270814|Drug|nab-paclitaxel|
16085163|NCT02270814|Drug|Cisplatin|
16085164|NCT02270814|Drug|Carboplatin|
16085165|NCT02270814|Biological|Cetuximab|
16085166|NCT02270801|Drug|rhTPO|rhTPO will be given intravenously at a dose of 300U/kg every day. Dose will be tapered to 300U/kg every other day when platelet count rise over 50×10^9/L. Maintenance will be continued after delivery and the dose will be further reduced to 300U/kg per week.
16085167|NCT02270788|Drug|Crenolanib|"Day 1 of Course 1: once followed by pharmacokinetic analysis. Days 2-28 of cycle 1: 3 times per day Crenolanib dose will not be adjusted unless the participant experiences side effects.
~All subsequent courses: 3 times per day on Days 1-28. At least 50% of participants in each dose level must be ≤ 18 years old."
16085168|NCT02270788|Drug|Sorafenib|"Days 8-28 of course 1: given orally once each day.
~All subsequent courses: given orally on days 1-28 once per day
~This is a dose-finding study for the use of sorafenib in combination with crenolanib. Different doses will be given to several participants, with the first participants receiving a lower dose than typically used in children as a single agent. If the drug does not cause serious side effects, it will be given to other study participants at a higher dose. If side effects occur, the dose will be lowered."
16085169|NCT02270788|Drug|methotrexate, hydrocortisone and cytarabine with leucovorin|Triple IT therapy includes methotrexate, hydrocortisone and cytarabine with leucovorin rescue given on day 8. All participants will receive one IT chemotherapy on Day 8 of the first cycle. If they do not have leukemia cells in their spinal fluid, they will receive only one IT chemotherapy per cycle. If leukemia cells are present in their spinal fluid, they will receive IT chemotherapy weekly during the course. Triple IT therapy will be repeated on Day 1 of Cycle 2 and with each subsequent cycle in all participants.
16085170|NCT02270762|Other|Rest in bed|
16085171|NCT02270762|Other|Passive verticalization|
16085172|NCT02270762|Other|Rest in bed|
16085173|NCT02270749|Drug|Hydroxocobalamin|patients are treated for 6 months with hydroxocobalamin. Patients will be treated with once a dose of 2000ug, after that treatment will be continued with a dose of 1000ug per 2 months. At timepoint 0, 2, 4 and 6 months after treatment vitamin B12 will be measured. At timepoint 0 and 6 also homocystein and methylmalonic acid will be measured.
16085174|NCT02270749|Drug|FitForMe vitamin B12|patients are treated for 6 months with a daily dose of 1000ug vitamin B12 tablets. At timepoint 0, 2, 4 and 6 months after treatment vitamin B12 will be measured. At timepoint 0 and 6 also homocystein and methylmalonic acid will be measured.
16085175|NCT02270736|Drug|NT 201 Placebo|NT 201 placebo matching injection.
16085176|NCT02270736|Drug|NT 201|NT 201 injection.
16085177|NCT02270723|Drug|"5% Human Albumin  Behring"|Intravenous infusion of 5% Human Albumin during major surgery
16085178|NCT02270723|Drug|Lactated Ringer|Intravenous infusion of Lactated Ringer during major surgery
16085179|NCT02270697|Device|Array|Applications of oligonucleotide array in diagnosis.
16085180|NCT02270684|Device|StepRite|The StepRite device uses an insole to monitor motion, and relays this information to the physical therapist via a smart phone app and web link. Set exercises can be programmed into the app for the participant to complete
16085181|NCT02270671|Behavioral|ABMT|Attention Bias Modification Training
16085182|NCT02270671|Other|Placebo|Placebo Training
16085183|NCT02270658|Device|CPAP|
16085184|NCT02270645|Device|595/1064 multiplex laser|595/1064 multiplex laser will be used 3 times spaced by a four week interval (+/- 3 days), it will be administered in an outpatient clinic setting.
16085185|NCT02270632|Drug|F8IL10|F8IL10 will be administered once a week for 8 weeks (or until withdrawn from the study).
16085186|NCT02270632|Drug|MTX|All patients enrolled in the study will receive as concomitant therapy MTX at stable dose (10-25 mg/week), and the corresponding fixed dose of folic acid.
16085187|NCT02270632|Drug|Placebo|Placebo will be administered once a week for 8 weeks (or until withdrawn from the study).
16085188|NCT02270619|Biological|Endotoxin|Low dose endotoxin (0.8 ng/kg of body weight) as IV bolus
16085189|NCT02270619|Behavioral|Partial sleep deprivation|Partial night sleep deprivation by staying awake from 23:00 to 03:00
16085190|NCT02270619|Other|Placebo|0.9% saline as IV bolus
16085191|NCT02270619|Other|Uninterrupted sleep|Uninterrupted sleep from 23:00 to 07:00
16085192|NCT02270606|Radiation|intensity-modulated radiation therapy|Undergo IMRT
16085193|NCT02270606|Drug|fluorouracil|Given IV
16085194|NCT02270606|Drug|oxaliplatin|Given IV
16085195|NCT02270606|Drug|leucovorin calcium|Given IV
16085196|NCT02270606|Procedure|therapeutic conventional surgery|Undergo total mesorectal excision
16085197|NCT02270580|Behavioral|PN+|"we will evaluate the efficacy of a culturally tailored PN program (PN+) on improving quality of life (QoL), screening practices and treatment follow-up compliance among breast HL survivors"
16085198|NCT02270580|Behavioral|PN usual|participants will receive information brochures on breast cancer survivorship and have a minimum of 1 contact with the patient navigator
16085199|NCT02270567|Device|NETest|Non-invasive blood test
16085200|NCT02270554|Device|Endo GIA Reinforced Reload with Tri-Staple technology|Device:Endo GIA Reinforced Reload with Tri-Staple technology
16085201|NCT02270541|Other|Telemedicine|In-ambulance telemedicine
16085202|NCT02270528|Behavioral|Exercise|10 seconds of sprinting on a bicycle ergometer against a resistance equivalent to 5.5% of a participant's body weight, followed by 20 seconds of rest, repeated 10 times. (~5 minutes)
16085203|NCT02270528|Behavioral|Cognitive Task|The Wisconsin Card Sorting Task (WCST) is a measure of Executive Function.
16085204|NCT02270515|Other|Patient-Centered Medical Home for Kidney Disease (PCMH-KD)|A PCMH-KD enhances the usual dialysis care team by adding a primary care doctor, pharmacist, nurse coordinator and community health worker to the care team.
16085311|NCT02269683|Procedure|Laparoscopic distal pancreatectomy|
16085205|NCT02270502|Device|Ultrasound Philips CX50|The Philips CX50 ultrasound system is used to measure muscle size of the patients. We will measure the area and diameter of the rectus femoris muscle via ultrasound.
16085206|NCT02270502|Other|Frailty Index Questionnaire|Frailty Index Questionnaire is a clinical tool to assess frailty in patients. We will ask patients to answer the questionnaire, including clarification that the questionnaire assesses the patient's pre-admission condition. The presence of a frail characteristic will be scored as 1 point. Most variables will be dichotomized (e.g. 1 point when a frail characteristic will be present and 0 points when frail characteristic will be not present).The Frailty Index will be calculated as the total number of frail characteristics of the patient divided by the total number of variables (n=50).
16085207|NCT02270502|Other|Muscle strength tests|MRC score is a clinical assessment of muscle power on abduction of the arm, flexion of the forearm, extension of the wrist, flexion of the leg, extension of the knee and dorsal flexion of the foot with the score of (0-5) on each measurement.
16085208|NCT02270489|Biological|AFFITOPE® PD01A + Adjuvant|s.c. injection
16085209|NCT02270489|Biological|AFFITOPE® PD03A + Adjuvant|s.c. injection
16085210|NCT02270489|Biological|Adjuvant without active component|s.c. injection
16085211|NCT02270463|Drug|SL-401|
16085212|NCT02270450|Procedure|therapeutic conventional surgery|Undergo abdominal surgery
16085213|NCT02270450|Procedure|gastrointestinal complications management/prevention|Undergo non-surgical management
16085214|NCT02270450|Other|quality-of-life assessment|Ancillary studies
16085215|NCT02270437|Drug|ropivacaine, fentanyl, adrenaline|The patients in the cocktail analgesia group received an injection of 200mg ropivacaine, 100ug fentanyl, and 0.25mg adrenaline into knee collateral ligaments, posterior aspect of the capsule, quadriceps tendon, patellar tendon, fat pad, periosteum, and synovium, along with PCIA morphine postoperatively.
16085216|NCT02270424|Drug|Salmeterol / fluticasone (Seretide®)|According to the revised 2013 GOLD, Salmeterol / fluticasone was used to severe and very severe COPD patients for 52weeks: Salmeterol / fluticasone (Seretide®, GlaxoSmithKline), 50/500 μg / dose, 60 inhalations. 50/500 μg each time, twice daily.
16085217|NCT02270424|Drug|Bufeijianpi granule|According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of deficiency of pulmono-splenic qi will be given Bufeijianpi granule, twice daily for 52 weeks for lower dosage.
16085218|NCT02270424|Drug|Bufeiyishen granule|According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi of the lung and kidney will be given Bufeiyishen granule, twice daily for 52 weeks for lower dosage.
16085219|NCT02270424|Drug|Yiqizishen granule|According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi and yin of the lung and kidney will be given Yiqizishen granule granule, twice daily for 52 weeks for lower dosage.
16085220|NCT02270424|Drug|Placebo Bufeijianpi granule|According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of deficiency of pulmono-splenic qi will be given placebo Bufeijianpi granule, twice daily for 52 weeks for lower dosage.
16085221|NCT02270424|Drug|Placebo Bufeiyishen granule|According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi of the lung and kidney will be given placebo Bufeiyishen granule, twice daily for 52 weeks for lower dosage.
16085222|NCT02270424|Drug|Placebo Yiqizishen granule|According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi and yin of the lung and kidney will be given placebo Yiqizishen granule granule, twice daily for 52 weeks for lower dosage.
16085223|NCT02270398|Behavioral|Dual-task training group|Balance and gait exercises while simultaneously engaging in a secondary cognitive task.
16085224|NCT02270398|Behavioral|Single-task training group|Balance/gait exercises and cognitive exercises done separately.
16085225|NCT02270398|Behavioral|Flexibility and strength training group|Whole-body flexibility exercises, upper limb strengthening exercises.
16085226|NCT02270385|Behavioral|PU prevention programme|The PU prevention programme consists of two major components which are an intensive training course(a 2-hour lecture and two skill training sessions) and a PU prevention protocol.
16085227|NCT02270385|Behavioral|Usual PU prevention care|Usual PU prevention care that is a series of basic nursing care activities: repositioning of residents, moisturization , change of napkins to keep buttock dry.
16085228|NCT02270372|Biological|ONT-10, Varlilumab combination|"ONT-10 a liposomal synthetic glycopolypeptide MUC1 targeted antigen formulated with PET Lipid A adjuvant.
~Varlilumab is a recombinant, fully human mAb of the IgG1κ isotype that specifically binds human CD27."
16085229|NCT02270359|Device|OCT|Optical coherence tomography (OCT): Intracoronary imaging for amount and type of plaque as well as plaque rupture, ulceration, dissection and/or thrombosis.
16085230|NCT02270359|Procedure|CMR|Cardiac magnetic resonance imaging (CMR): MRI of the heart to identify areas of infarction (damage) and/or edema (smelling)
16085231|NCT02270359|Drug|contrast agent, Gadolinium|Gadolinium contrast will be administered during CMR
16085232|NCT02270346|Device|Inspiratory muscle training|"Treatment group received inspiratory muscle training using threshold loading device (POWERbreathe Classic, IMT Technologies Ltd. Birmingham, England) at 40% of maximal inspiratory pressure (MIP).
~The MIP was measured at supervised session each week, and 40% of measured MIP value was the new training workload.
~The treatment group trained for 30 min-per/day, 7 days/week, for 6 weeks. Six sessions at home and 1 session were performed at department."
16085233|NCT02270346|Device|Sham inspiratory muscle training|"Control group received sham inspiratory muscle training using threshold loading device (POWERbreathe Classic IMT Technologies Ltd. Birmingham, England) at fixed workload, 5% of MIP.
~The control group trained for 30 min-per/day, 7 days/week, for 6 weeks. Six sessions at home and 1 session were performed at department."
16085234|NCT02270333|Device|Inspiratory muscle training|"Treatment group received inspiratory muscle training (IMT) using threshold loading device (POWERbreathe Classic, IMT Technologies Ltd. Birmingham, England) at 40% of maximal inspiratory pressure (MIP).
~The MIP was measured at supervised session each week, and 40% of measured MIP value was the new training workload.
~The treatment group trained for 30 min-per/day, 7 days/week, for 6 weeks. Six sessions at home and 1 session were performed at department."
16085312|NCT02269670|Drug|everolimus|Given PO
16085313|NCT02269670|Drug|anastrozole|Given PO
16085314|NCT02269670|Drug|letrozole|Given PO
16085235|NCT02270333|Device|Sham inspiratory muscle training|"Control group received sham inspiratory muscle training (IMT) at fixed workload, 5% of MIP using threshold loading device (POWERbreathe Classic device IMT Technologies Ltd. Birmingham, England).
~The control group trained for 30 min-per/day, 7 days/week, for 6 weeks. Six sessions at home and 1 session were performed at department."
16085236|NCT02270320|Behavioral|Physical activity|The training is 24 forms Yang-style Tai Chi Chuan exercise, which will perform a 60-minute exercise program, three times per week for 12 weeks.
16085237|NCT02270307|Drug|Cyclophosphamide|Dose 50 mg/kg at day +3,+4 once daily
16085238|NCT02270307|Biological|Mesenchymal stromal cells|Dose 1 million per kg, at day of recovery once
16085239|NCT02270294|Other|Thai traditional massage|Thai traditional massage treatment based on original Thai traditional massage at Wat Po was use in this study. The participants will be assigned to receive one time of Thai traditional massage one time. Thai traditional massage techniques consists of petrissage, friction, and passive stretching on head, neck, shoulders, arms, back and legs for 60 minutes.
16085240|NCT02270294|Other|No massage|The participants will be asked to lie down in relaxant position on bed without sleep for 60 minutes.
16085241|NCT02270281|Drug|Dexmedetomidine 0.7 Mcg/kg/h|CIF 0.7mcg/kg/h
16085242|NCT02270268|Dietary Supplement|Pectin|Pectin （Andeli Ltd. Yantai, China）, 24g/d for six weeks
16085243|NCT02270268|Dietary Supplement|maltodextrin|
16085244|NCT02270255|Procedure|Superior hypogastric nerve block|21g Chiba needle advanced into the superior hypogastric plexus via an anterior infraumbilical approach using the arterial catheter as a fluoroscopic landmark to target the vertebral body below.
16085245|NCT02270255|Drug|0.75% Ropivacaine|20 ml of 0.75% Ropivacaine
16085246|NCT02270255|Procedure|Subcutaneous injection|Injection into subcutaneous tissues in periumbilical region
16085247|NCT02270255|Drug|1% Xylocaine|5ml of 1% Xylocaine
16085248|NCT02270242|Drug|Aspirin|
16085249|NCT02270242|Drug|Placebo|
16085250|NCT02270242|Drug|ticagrelor|
16085251|NCT02270216|Procedure|static hand grip exercise|The static exercise pressor response will be tested using isometric handgrip of the left hand. The forearm will be supported on an arm rest with elbow flexed. The maximum voluntary contraction force will be measured as the best of three attempts. After 2 minute rest, subjects will perform 2 minute of isometric hand grip contraction at 30% MVC. Circulatory occlusion(50 mmHg supra-systolic pressure) will start at 1.30 min and continued for 2 minute after the end of the isometric handgrip exercise. Following release of the cuff there will be a further 2 minutes recovery. The blood pressure and heart rate will be measured at the end of each minute during rest, isometric handgrip, circulatory occlusion and recovery. Subjects will be instructed to breathe normally during the test and avoid any Valsalva maneuver; breathing frequency will be monitored during the handgrip pressor test using capnography.
16085252|NCT02270216|Procedure|cycling exercise|"The dynamic exercise will be with the subject sitting on a cycle ergometer (Monark 828 E). Resting heart rate will be measured for 2 minutes before the start of exercise. The exercise level will be limited to 50% of the estimated maximum heart rate reserve. Maximum heart rate will be estimated as 207-0.7*age and heart rate reserve (HRR) as maximum minus resting heart rate. Subjects will pedal at 50 rpm for 1 min with no load and then 3 minutes against a load of 0.5 Kp (25W) increasing to a load of 1 Kp for the next 3 minutes and to 1.5 Kp, if necessary, for a further 3 minutes until the target heart rate of 50% HRR is reached.
~Subjects will be asked about their level of perception of dyspnea using a visual analog scale every 3 minutes at the end of each load. At the end of the exercise, the subjects will sit for ten minutes."
16085253|NCT02270203|Radiation|Pelvic CT at 5 years post-op|Pelvic CT at 5 years post-op
16085254|NCT02270190|Device|Percutaneous Tibial Nerve Stimulation (PTNS)|
16085255|NCT02270177|Other|Telemedicine, videoconsultation|We are investigating the use of videoconsultations (through telemedicine technology) in patients with primary headaches.
16085256|NCT02270164|Dietary Supplement|Artichoke Leaf Extract|Capsule
16085257|NCT02270164|Other|Placebo|Capsule
16085258|NCT02270151|Device|MyDiagnostick|Diagnostick strategy with MyDiagnostick
16085259|NCT02270138|Behavioral|Movement-to-music video program|Three separate movement-to-music video programs will be utilized. Genres of the songs are Children's rock, latin and folk. Range of the tempo is 64-124 beats per minute. The use of movement-to-music video program will be instructed 10-30 minutes every other day.
16085260|NCT02270125|Procedure|Mucotomy|Surgical removal of hypertrophic mucosa of the inferior nasal turbinate by cold-steel instruments under endoscopic control, under general anaesthesia
16085261|NCT02270112|Device|ECG|Patients receive a 5 Minute ECG recording and have their pulse recorded by an iPhone.
16085262|NCT02270073|Behavioral|Cognitive behavior therapy of trainee therapists|In all three treatment arms, trainee therapists perform a cognitive behavior therapy (CBT) under conditions of the German health care system. This treatment is not a manualized intervention, but rather based on individualized treatment plans that have been developed together with expert supervisors during a five session diagnostic stage. Treatment duration is 25 sessions, while on average every fourth is supervized by an CBT expert therapist.
16085263|NCT02270060|Other|Music Therapy|Patient receives a single 20-minute music therapy session with a music therapist. Patient will interact with specially composed music tailored to the patient's preferences using an iPad.
16085264|NCT02270060|Other|Music Listening|Patient listens to his/her preferred music on an iPod touch for 20 minutes without the presence of a music therapist.
16085265|NCT02270047|Dietary Supplement|Orange nectar|Orange nectar
16085266|NCT02270047|Dietary Supplement|Orange Nectar with fibre|
16085267|NCT02270034|Drug|Crizotinib|Crizotinib is added to Stupp method
16085268|NCT02270021|Other|Provider Mobile Application (ProvAPP)|Mobile phone application to maneuver clinicians through the cervical cancer screening and treatment guidelines based on patient age and condition.
16085269|NCT02270021|Other|ProvAPP + Patient Educational Tool (Tab)|"Patient Educational Tool (Tab): A patient educational tool (mobile tablet) will educate women on cervical cancer screening and treatment. Patients' self-assessment using a tablet at the time of clinic check-in will help them to understand current guidelines and their choices for treatment if they have abnormal cytology. It will allow them to assess the risks and benefits of screening intervals and of treatment choices.
~ProvAPP: Mobile phone application to maneuver clinicians through the cervical cancer screening and treatment guidelines based on patient age and condition."
16085270|NCT02270008|Other|Pelvic floor training|Baseline muscle strength will be measured with the modified Oxford scale. The intervention group will undergo an in-person standardized pelvic strength training session by a trained nurse practitioner.
16085271|NCT02269995|Device|E7040|E7040 of optimal particle size (-300 um, 300-500 um, or 500-700 um to fit in a target vessel, target lesion, or embolized area) as transcatheter study device will be administered .
16085272|NCT02269982|Device|AR-v7 assays|
16085273|NCT02269969|Drug|Tobramycin|
16085274|NCT02269956|Behavioral|12 week feasibility study|: At baseline, weeks 6 and 12, dementia feeding skills knowledge and self-efficacy tests will be administered, meal observations of nursing staff assisting PWD with meals will be video recorded for three meals over two days, and a medical record review will be conducted to ascertain technical and adaptive interventions also in place for the PWD (e. g., high density protein supplements, appetite stimulant medications, weighing, diet texture modifications). After baseline data is collected, the training program will delivered in five weekly modules with group coaching sessions completed the same week
16085275|NCT02269943|Drug|CC-486|
16085276|NCT02269930|Drug|peginterferon beta-1a|Administered as subcutaneous injection
16085277|NCT02269930|Drug|Rebif|Administered as subcutaneous injection
16085278|NCT02269917|Drug|D/C/F/TAF|Once-daily single-tablet regimen containing darunavir (DRV) 800 milligram (mg)/ cobicistat (COBI) 150 mg/ emtricitabine (FTC) 200 mg/ tenofovir alafenamide (TAF) 10 mg.
16085279|NCT02269917|Drug|Boosted Protease Inhibitor (bPI)|Boosted protease inhibitor (limited to darunavir [DRV] or atazanavir with low-dose ritonavir [rtv] or cobicistat [COBI], or lopinavir with rtv) as per current treatment regimen.
16085280|NCT02269917|Drug|FTC/TDF|Emtricitabine/tenofovir disoproxil fumarate (FTC/TDF).
16085281|NCT02269904|Drug|Fluorouracil Implants|Fluorouracil Implants: 800mg, implanted in the abdominal cavity during operation.
16085282|NCT02269904|Drug|Xelox regimes|Xelox regimes: Capecitabine,1000 mg/m2，PO.BID, from D1 to D14; Oxaliplatin, 130 mg/m2，IV, D1 in each cycle. The cycle will repeated every 21 days till 6 cycles finished.
16085283|NCT02269891|Dietary Supplement|Nu Femme|Combination product of Labisia pumila and Eurycoma longifolia extracts
16085284|NCT02269891|Other|Placebo|
16085285|NCT02269852|Biological|trivalent seasonal influenza vaccine|"Infants: 0.25 ml/ dose;
~Adults: 0.5 ml/ dose;
~Seniors: 0.5 ml/ dose;"
16085286|NCT02269839|Device|rTMS|Active treatment will consist of sessions of continuous theta-burst rTMS on consecutive days for 5 days. This will be delivered with a circular coil to the temporal scalp region overlying the auditory cortex, contralateral to the symptomatic side in unilateral tinnitus and to the left side in bilateral tinnitus. The treatment protocol will consist of treatment at 80% of individual motor threshold (established at the first treatment session) for 600 pulses of 40 seconds duration, which will be repeated after 15 minutes. Each patient will receive 1200 pulses per day.
16085287|NCT02269826|Device|Vagisan® Moisturising Cream|Once in the evenings before going to bed, intravaginally with the help of the applicator included (approximately 2.5 g per application) and perivaginally one fingertip unit (approximately 0.5 g per application).
16085288|NCT02269826|Device|Gynomunal® vaginal gel|Once in the evenings before going to bed, intravaginally with the help of the applicator included (approximately 2.5 g per application) and perivaginally one fingertip unit (approximately 0.5 g per application).
16085289|NCT02269813|Other|MammaPrint|
16085290|NCT02269813|Other|BluePrint|
16085291|NCT02269813|Other|TargetPrint|
16085292|NCT02269800|Drug|Benzalkonium chloride solution|Tid, 7 days
16085293|NCT02269800|Drug|Normal saline|Tid, 7 days
16085294|NCT02269787|Behavioral|Enhanced Telephone Monitoring|Detox inpatients in the ETM condition will be expected to complete one session while in detox and one 15-minute telephone call per week for 12 weeks (plus usual care).
16085295|NCT02269774|Procedure|Standard pulmonary vein isolation|The MM will be carried out during a elective standard pulmonary vein isolation procedure. The MM will be performed using an occluded mouthpiece with a small air leak to prevent complete closure of the glottis during inspiration and thus assure negative pressure throughout the entire airway. After expiration, inspiration with a target negative intrathoracic pressure of -40mmHg will be carried out against the mouthpiece.
16085296|NCT02269761|Device|Nuvis Diagnostic Ultrasound System|Ultrasound of the chest
16085297|NCT02269748|Procedure|Tunnel technique with subepithelial connective tissue|After harvesting a connective tissue graft from the palate, the graft is placed under a gingival tunnel prepared over the donor site.
16085298|NCT02269748|Procedure|Coronally advanced flap|After harvesting a connective tissue graft from the palate, the graft is placed under a gingival flap which is repositioned coronally
16085299|NCT02269748|Drug|Analgesic Therapy|Ibuprofen 600 mg TID
16085300|NCT02269735|Drug|MK-2640|MK-2640 intravenous infusion administered to participant in a fasted state
16085301|NCT02269735|Biological|Regular Human Insulin (RHI)|RHI 100 units/mL intravenous infusion to maintain target glycemic level
16085302|NCT02269735|Drug|Dextrose|Dextrose 20% or 50% intravenous infusion for approximately 9 or 7 hours, as appropriate to attain a target glycemic level
16085303|NCT02269735|Biological|Insulin aspart|Insulin aspart subcutaneous injection or intravenous infusion the evening before each period in Parts II and III to achieve/maintain glycemic target.
16085304|NCT02269735|Drug|Rescue medication|Rescue medication may be administered for hypotension or mild to moderate infusion reaction. Rescue medication may include epinephrine, antihistamines, steroids, or acetaminophen/paracetamol.
16085305|NCT02269722|Device|Vascular compression device- RADAR TM-Short clamp time|A clamp is placed on the radial artery following cardiac catheterization for 20 minutes
16085306|NCT02269722|Device|Vascular compression device RADAR TM-Long clamp time|A clamp is placed on the radial artery following cardiac catheterization for 20 minutes
16085307|NCT02269709|Device|ARFI Ultrasound|This research scan uses acoustic radiation force impulse (ARFI) shear wave velocity imaging (SVI). This is a new ultrasound technology in which unique sound waves create the images/pictures of the liver beng examined/scanned. This ultrasound scan will take approximately 10 minutes to complete.
16085308|NCT02269696|Drug|Metoprolol|Intraoperative metoprolol infusion.
16085309|NCT02269696|Drug|Normal saline|Equal of volume compared to metoprolol.
16085310|NCT02269683|Procedure|Robot-assisted distal pancreatectomy|
16085318|NCT02269657|Device|EOS® imaging system|The EOS® imaging system is a low dose, 3-dimensional imaging system that provides weight bearing images which provide visual information with respect to the interaction between the joints and the rest of the musculoskeletal system, particularly the spine, hips and legs. The imaging system is used for clinical purposes with additional images captured as part of this study to collect data from subjects in two different arm positions during imaging.
16085319|NCT02269644|Drug|Dalbavancin|dalbavancin 1500 mg IV over 30 minutes on Day 1
16085320|NCT02269644|Drug|Linezolid|linezolid 600 mg every 12 hours for a minimum of 10 days and a maximum of 14 days
16085321|NCT02269644|Drug|Linezolid Placebo|Dalbavancin randomized subjects after Day 1, 1st dose will receive linezolid placebo every 12 hours for a minimum of 10 days and a maximum of 14 days
16085322|NCT02269644|Drug|Azithromycin|Dalbavancin and linezolid randomized subjects on Day 1, 1st dose receive 500 mg of IV azithromycin
16085323|NCT02269631|Behavioral|Legume diet group|about 1 1/2 cups of legumes included in lunch and dinner meals
16085324|NCT02269631|Behavioral|Control diet group|no legumes in lunch or dinner meals
16085325|NCT02269631|Device|Smartpill|to assess how long food takes to pass through the digestive system
16085326|NCT02269631|Other|legumes|about 1 1/2 cups of legumes included in lunch and dinner meals
16085327|NCT02269618|Other|Home-based telehealth program|"Home-based telehealth program
~Scheduled calls initiated by nurse performed weekly; the nurse carried out a standardized interview on general clinical condition of the patients.
~Unscheduled calls initiated by patients or caregivers through the service centre(24h/24h) to report any clinical problems. in case of signs or symptoms
~Telemonitoring: during calls, patients can transmit via landline or mobile phone the recordings from the 1-lead ECG to a service centre, and talk to the nurse or doctor
~Home visit performed by therapist seven days after hospital discharge by setting the daily physical activity and other home visits in case of need
~Scheduled calls initiated by therapist performed weekly aimed at increasing workload and evaluating the proper execution of exercises."
16085328|NCT02269618|Other|Home-based rehabilitation|"Home-based rehabilitation Individual rehabilitative program including at least 3 sessions/week of mini-ergometer and exercises and 2 sessions/week of walking with pedometer
~Mini-ergometer: The personalized protocol will be structured at the beginning on the basis of data obtained from the assessment of the baseline exercise test, trying to get a training activity to the maximum value of around a Borg dyspnoea and motor equal to 6 (according to the protocol of Maltais)
~Walking: The patient will be encouraged to walk every day. Will be given a pedometer and will be asked to try to increase the amount of steps up to the maximal for the patient."
16085329|NCT02269618|Other|Usual care|Usual care All patients will be followed also in usual care manner by their GPs.
16085330|NCT02269605|Other|Placebo|Group 1: Placebo (sodium chloride 0.8 %) at single dose
16085331|NCT02269605|Drug|Bryostatin 1 (10ug/m2)|Group 2: Bryostatin 1 (10ug/m2) at single dose
16085332|NCT02269605|Drug|Bryostatin 1 (20ug/m2)|Group 3: Bryostatin 1 (20ug/m2) at single dose
16085333|NCT02269579|Drug|CPX-351|
16085334|NCT02269566|Drug|HollisterStier|0.1 ml of 30 AU/ml for Df or Dp, 10 AU/ml for Cat hair, and/or 1:1/10 weight/volume for dog hair/dander 3 injections into an inguinal lymph node
16085335|NCT02269566|Drug|Normal saline|0.1 ml of normal saline 3 injections into an inguinal lymph node
16085336|NCT02269553|Device|TMJ(TM) NextGeneration|The TMJ NextGeneration(TM) device consists of a pair of small, hollow ear inserts.
16085337|NCT02269553|Device|Standard Hard TMJD Splint|The occlusal splint to be used in this study will be a hard, full-arch splint with at least one occlusal contact on each tooth of the opposing arch.
16085338|NCT02269540|Drug|Sertraline|selective serotonin reuptake inhibitor
16085339|NCT02269540|Drug|Citalopram|selective serotonin reuptake inhibitor
16085340|NCT02269540|Drug|N-acetylcysteine (NAC)|natural health product
16085341|NCT02269540|Drug|Existing depression medication treatment|Continuation of depression medication treatment already taken prior to study enrollment except for drugs with affinity for MAO-A or potentially influencing MAO-A levels, including phenelzine, tranylcypromine, moclobemide, cytomel and lithium
16085342|NCT02269527|Other|Live music|Providing 1-hour live music 5 days/ week.
16085343|NCT02269514|Other|Own Brand Cigarette|combustible cigarette brand style smoked most frequently by subject
16085344|NCT02269514|Other|Electronic Cigarette #1|VUSE® Digital Vapor Cigarette (original flavor, 14mg nicotine)
16085345|NCT02269514|Other|Electronic Cigarette #2|VUSE® Digital Vapor Cigarette (original flavor, 29mg nicotine)
16085346|NCT02269514|Other|Electronic Cigarette #3|VUSE® Digital Vapor Cigarette (original flavor, 36mg nicotine)
16085347|NCT02269514|Other|Leading U.S. Nicotine Gum|4 mg nicotine polacrilex gum
16085348|NCT02269501|Other|Exercise treatment|
16085349|NCT02269488|Drug|MEDI3250|MEDI3250
16085350|NCT02269475|Drug|MEDI3250|MEDI3250
16085351|NCT02269475|Drug|Placebo|Placebo
16085352|NCT02269462|Drug|Efavirenz|600 mg once daily in combination with other drugs (e.g. tenofovir and emtricitabine)
16085353|NCT02269462|Drug|Nevirapine|200 mg twice daily in combination with other drugs (e.g. tenofovir and emtricitabine)
16085354|NCT02269449|Device|6Fr Glidesheath Slender sheath|6Fr sheath (Glidesheath slender: GSS), which is characterized with the same inner lumen diameter with contemporary 6Fr sheath as well as the sheath outer diameter similar with contemporary 5Fr sheath.
16085355|NCT02269449|Device|5Fr sheath|5Fr Hydrophilic coating sheath from Terumo.
16085356|NCT02269449|Procedure|Hemostasis with TR band|Hemostasis is achieved using TR band (TERUMO) Patent hemostasis.
16085357|NCT02269449|Procedure|Any hemostasis procedure|Hemostasis is achieved by any hemostasis of each hospital's routine procedure.
16085358|NCT02269436|Drug|sNN0029 infusion solution|4 µg/day, continuous i.c.v administration
16085359|NCT02269423|Biological|V920|Vesicular Stomatitis Virus (VSV)-based vaccine 1-mL injection containing 3x10^6, 2x10^7, or 1x10^8 pfu.
16085360|NCT02269423|Other|Placebo|Normal saline placebo.
16085361|NCT02269410|Dietary Supplement|GBP-SPS|Protein powder supplementation will be given to participants to add to regular foods during the dietary intervention phase until reach protein objectives based on randomization and during 12 weeks after Bariatric Surgery.
16085461|NCT02268760|Drug|BILN 2061 ZW fixed dose|
16085462|NCT02268760|Other|Standardized breakfast|
16085362|NCT02269410|Dietary Supplement|GBP-HPS|Protein powder supplementation will be given to participants to add to regular foods during the dietary intervention phase until reach protein objectives based on randomization and during 12 weeks after Bariatric Surgery.
16085363|NCT02269410|Dietary Supplement|VSG-SPS|Protein powder supplementation will be given to participants to add to regular foods during the dietary intervention phase until reach protein objectives based on randomization and during 12 weeks after Bariatric Surgery.
16085364|NCT02269410|Dietary Supplement|VSG-HPS|Protein powder supplementation will be given to participants to add to regular foods during the dietary intervention phase until reach protein objectives based on randomization and during 12 weeks after Bariatric Surgery.
16085365|NCT02269384|Procedure|Experimental Noxious Stimulus|Localized manual pressure will be placed up predetermined points on the lower extremity until maximum pain tolerance levels are reached.
16085366|NCT02269384|Behavioral|Memory of Experimental Noxious Stimulus|Subjects will be asked to visualize previously experience experimental noxious stimulus
16085367|NCT02269384|Behavioral|Memory of Prior Significant Injury|Subjects will visual prior significant injury or a predetermined lower extremity region in control subjects.
16085368|NCT02269384|Procedure|Mental Challenge Test|Subjects will count backwards from 100 by specified amounts as rapidly as possible
16085369|NCT02269371|Other|Auricular Acupuncture|Standard of care weight loss intervention plus auricular acupuncture at Shen Men, Point Zero, and Appetite Control Point/Hunger Point in each ear.
16085370|NCT02269371|Other|Sham Acupuncture|Standard of care weight loss intervention plus sham acupuncture at three nonacupoints in each ear.
16085371|NCT02269358|Drug|METHOTREXATE|Infliximab therapy after escalation. SC methotrexate at 15 mg/m2 , not to exceed 25 mg/m2 per week for 4 weeks. Patients in remission after 4 weeks reduce their dose by halve. patients not in remission will continue the full dose until 12 weeks.
16085372|NCT02269345|Other|Battlefield Acupuncture|Battlefield Acupuncture at points cingulate gyrus, thalamus, omega 2, shen-men, point zero
16085373|NCT02269345|Other|Standard Treatment|Standard Treatment alone.
16085374|NCT02269332|Other|Screening Colonoscopy|we will obtain serum vitamin D blood levels from those scheduled for a screening colonoscopy or polyp surveillance
16085375|NCT02269319|Drug|MRX-I|Oral MRX-I 800mg given twice a day for 10 days
16085376|NCT02269319|Drug|Linezolid|Oral linezolid 600mg given twice a day for 10 days
16085377|NCT02269306|Drug|clomiphen citrate|The study was carried out on 150 patients with PCOS. Initial clomiphen citrate (CC) doses were 50 mg daily for 5 days starting on cycle day 3. In the case of an absent response, doses were increased to 100 and 150 mg daily in subsequent cycles. First ovulation with CC was used as the end point.
16085378|NCT02269293|Drug|Paclitaxel|
16085379|NCT02269293|Drug|Carboplatin|
16085380|NCT02269293|Drug|Selinexor|
16085381|NCT02269280|Drug|Azacitidine (AZA) Days 1 - 3|Azacitidine 75 mg/m2 by vein or subcutaneously daily for 3 days (days 1-3) approximately every 28 days.
16085382|NCT02269280|Drug|Decitabine (DAC)|Decitabine 20 mg/m2 by vein for 3 days (days 1-3) approximately every 28 days.
16085383|NCT02269280|Other|Best Supportive Care (BSC)|Participants receive standard of care as chosen by study doctor. Best supportive care for transfusion-independent participants only.
16085384|NCT02269280|Drug|Azacitidine (AZA) Days 1 - 5|Azacitidine 75 mg/m2 by vein or subcutaneously daily for 5 days (days 1-5) approximately every 28 days.
16085385|NCT02269267|Other|Stopping their TKI|Patients with CML on treatment with imatinib, dasatinib, nilotinib, or bosutinib and are in confirmed deep molecular response will stop their TKI. Confirmed deep (> 4 log reduction) molecular response (>MR4) defined as p210 (bcr-abl) fusion protein (BCR-ABL) < 0.01%, for at least two years. Concurrently, the study will assess a wide range of PROs before stopping TKIs and after discontinuation in conjunction with PCR testing, though at fewer time points, utilizing online and/or phone questionnaires.
16085386|NCT02269254|Device|Persona PS Knee Prosthesis by Zimmer|Total Knee Replacement with Persona PS Knee Prosthesis by Zimmer
16085387|NCT02269254|Device|NexGen PS Knee Prosthesis by Zimmer|Total Knee Replacement with NexGen PS Knee Prosthesis by Zimmer
16085388|NCT02269241|Drug|LF111 (drospirenone)|One LF111 tablet once per day for 24 days followed by 4 placebo tablets for 4 days equals one cycle.
16085389|NCT02269228|Drug|Asasantin ER|
16085390|NCT02269228|Drug|Placebo|
16085391|NCT02269215|Drug|BIII 890 CL|
16085392|NCT02269215|Drug|Placebo|
16085393|NCT02269202|Drug|Midazolam, tablet|
16085394|NCT02269202|Drug|Crobenetine, i.v. infusion|
16085395|NCT02269202|Drug|Placebo|
16085396|NCT02269189|Drug|BIIL 284 BS, high dose|
16085397|NCT02269189|Drug|BIIL 284 BS, low dose|
16085398|NCT02269189|Drug|Placebo|
16085399|NCT02269176|Drug|Low dose of telmisartan|
16085400|NCT02269176|Drug|High dose of telmisartan|
16085401|NCT02269176|Drug|Low dose of losartan|
16085402|NCT02269176|Drug|High dose of losartan|
16085403|NCT02269163|Biological|Immune Globulin Intravenous|Gammargard, Gammaplex,Gamunex, or Octogam IGIV Product
16085404|NCT02269163|Biological|Prometic's Immune Globulin Intravenous 10%|Liquid formulation of Prometic Immune Globulin Intravenous 10% (human) in 50 mL vials containing 100 mg/mL of immunoglobulin G (IgG)
16085405|NCT02269150|Biological|fecal microbiota transplantation (FMT)|
16085406|NCT02269150|Other|No fecal microbiota transplantation (FMT), routine management|
16085407|NCT02269124|Device|Hearing aid|The subject will wear a hearing aid at all times for a 3-month period. At school, he/she will wear this hearing aid in addition to using conventional measures (FM system and preferential seating).
16085408|NCT02269111|Procedure|diffusion-weighted magnetic resonance imaging|Undergo DW-MRI
16085409|NCT02269111|Procedure|chemical exchange saturation transfer magnetic resonance imaging|Undergo CEST-MRI
16085410|NCT02269111|Procedure|dynamic contrast-enhanced magnetic resonance imaging|Undergo DCE-MRI
16085411|NCT02269111|Procedure|dynamic susceptibility contrast-enhanced magnetic resonance imaging|Undergo DSC-MRI
16085455|NCT02268786|Other|Preimplantation Genetic Screening by NGS|The VeriSeq PGS takes advantage of next-generation sequencing (NGS) technology to provide comprehensive, accurate screening of all 24 chromosomes for selection of euploid embryos.
16085456|NCT02268773|Drug|Asasantin®|
16085412|NCT02269098|Other|Diabetes medication management|As above plus- Follow-up intervention visits were at 24-72 hrs, 2 and 4 weeks. During each, further DSME was provided, BG logs reviewed, and diabetes medications adjusted as needed by the CDE. Meter and insulin injections skills were reinforced as needed. Outpatient navigation included securing a primary care appointment no later than 4 weeks after study completion. Final contact was via telephone at 90 days. The MMS© (Morisky Medication Adherence Survey) was taken at 2 and 4 weeks and during the final telephone visit. Interim return visits to the ED or admissions to the hospital were queried at each visit. A follow up HbA1C was obtained at week 4 using the POC A1CNow+ ®, and a venous HbA1C was drawn if the POC result was above 13% .
16085413|NCT02269085|Drug|Ibrutinib|"Phase I Starting Dose: 420 mg by mouth daily on Days 1 - 28 of a 28-day cycle.
~Phase II Starting Dose: MTD from Phase I."
16085414|NCT02269085|Drug|Carfilzomib|"Phase I Starting Dose: 20 mg/m2 by vein on Days 1, 2, 8 ,9, 15 and 16 in Cycles 1 - 12, and Days 1,2 and 15,16 of Cycle 13 and beyond.
~Phase II Starting Dose: MTD from Phase I."
16085415|NCT02269085|Behavioral|Phone Calls|Study staff calls participant after end-of-dosing visit every 6 months for 5 years. These calls should take about 2-3 minutes.
16085416|NCT02269072|Drug|Testosterone|Testosterone cream applied daily for two weeks
16085417|NCT02269072|Drug|Nesiritide|Administered IV once during the study
16085418|NCT02269072|Drug|Leuprolide|Administered twice during the study by injection
16085419|NCT02269072|Drug|Anastrozole|Daily pill for 8 weeks
16085420|NCT02269072|Drug|Placebo|Inert cream otherwise identical to testosterone cream applied daily for two weeks
16085421|NCT02269059|Drug|MK-7680|MK-7680 10 mg and 100 mg capsules
16085422|NCT02269046|Other|acupuncture and moxibustion|Warm needling acupuncture on Fenglong (ST40, bilateral), Zusanli (ST36, bilateral), Sanyinjiao (SP6, bilateral) and Cake-seperated moxibustion on Juque (RN14), Tianshu (ST25, bilateral), Pishu (BL20, bilateral), Xinshu (BL15, bilateral), Ganshu (BL18, bilateral), Shenshu (BL23, bilateral)
16085423|NCT02269046|Drug|Simvastatin|10mg/d,p.o,12 weeks.
16085424|NCT02269046|Other|Therapeutic Lifestyle Change|"Reduced intakes of saturated fats (<7% of total calories) and cholesterol (<200 mg per day)
~Therapeutic options for enhancing LDL lowering
~Weight reduction
~Increased physical activity"
16085425|NCT02269033|Behavioral|Patient Navigated Latinas|Patient navigators provided culturally sensitive support and guidance to Latina women who presented radiologic abnormalities categorized as BI-RADS 3, 4 and 5. Patient Navigators also collected clinical information from the patients' medical charts.
16085426|NCT02269033|Behavioral|Non Navigated Latinas|A convenience sampling approach was used to recruit non navigated Latinas. Eligibility criteria targeted self-identified Latinas at community-based health clinics, aged > 18 years with an abnormal breast screening mammogram resulting in BI-RADS 3, 4 or 5. Controls were chosen by determining eligibility consecutively backwards from the study start date.
16085427|NCT02269020|Procedure|Neck Dissection|Unilateral Selective Neck Dissection at Lymph Node Levels IIa, III and IV Using a Robot-assisted Transaxillary Approach. The robotic system used is the da Vinci system.
16085428|NCT02269007|Biological|inactivated quadrivalent influenza vaccine (split virion)|0.5ml inactivated quadrivalent influenza vaccine (split virion) for each subject, one dose
16085429|NCT02268994|Drug|ferric citrate|1 g ferric citrate containing approximately 210 mg of ferric iron
16085430|NCT02268994|Drug|Placebo|Matching placebo
16085431|NCT02268981|Device|Oxymizer® compared to CNC|Oxygen Saturation measurement for 12 h with CNC
16085432|NCT02268981|Device|Oxymizer® compared to CNC|Oxygen Saturation measurement for 12 h with Oxymizer®
16085433|NCT02268981|Device|Oxymizer® compared to CNC|Saturation measurement for 12 h with Oxymizer® by reduced flow rate (-1l/min)
16085434|NCT02268968|Drug|Lidocaine 2% Gel|Lidocaine 2% gel will be applied to nostrils and nasal CPAP prong 5 minutes prior to application of nasal CPAP
16085435|NCT02268955|Drug|IV Ibuprofen|Intravenous ibuprofen will be administered for treatment of pain in adults presenting to the ED with biliary colic
16085436|NCT02268955|Drug|Saline|Saline will be administered to the placebo group
16085437|NCT02268942|Device|HeartWare HVAD|Implant of HeartWare HVAD via thoracotomy implant technique
16085438|NCT02268942|Procedure|Thoracotomy|Thoracotomy implant technique
16085439|NCT02268929|Device|Accu-Chek Smart Pix Software|Software with adherence evaluation software used according to Integrated Personalized Diabetes Management (PDM)
16085440|NCT02268929|Device|Accu-Chek Smart Pix readout Device|Smartpix device for data upload out from blood glucose meter devices
16085441|NCT02268916|Behavioral|Counseling|OT led counseling
16085442|NCT02268916|Behavioral|Usual education|At the end of the study, will receive OT-led counseling
16085443|NCT02268903|Drug|Diuretics : Furosemide|Furosemide 80mg in one single direct intra venous injection
16085444|NCT02268903|Drug|Placebo|Placebo in one single direct intra venous injection
16085445|NCT02268890|Drug|Bortezomib|Participants will receive a 1.3 milligram per square meter per dose (mg/m^2/dose) of bortezomib intravenously on Days 1, 4, 8, and 11.
16085446|NCT02268877|Other|Emergency Medicine Physician Ultrasound|An ultrasound will be performed by an emergency medicine resident or attending physician
16085447|NCT02268877|Device|Ultrasound|An ultrasound will be performed by a radiology department technician
16085448|NCT02268864|Drug|Simeprevir|Simeprevir 150 mg oral capsule will be administered once daily for 12 or 24 weeks.
16085449|NCT02268864|Drug|Daclatasvir|Daclatasvir 60 mg oral tablet will be administered once daily for 12 or 24 weeks.
16085450|NCT02268851|Drug|TGR-1202|Capsules taken whole daily with water and with food
16085451|NCT02268851|Drug|Ibrutinib|Capsules taken whole with water- Do not consume fish oil, vitamin E, grapefruit, or Seville oranges
16085452|NCT02268838|Drug|E6007|
16085453|NCT02268838|Drug|E6007 matching placebo|
16085454|NCT02268825|Drug|MK-3475|"MK-3475 in combination with mFOLFOX6 in a 14 day cycle
~Phase 1 and safety expansion Phased Regimen mFOLFOX6 Administered Day 1 of each cycle Leucovorin 400 mg/m2 IV 5-FU 400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hrs Oxaliplatin (Eloxatin) 85 mg/m2 IV
~MK-3475 IV to be administered before mFOLFOX6 starting with Cycle 3 (after 28 days of chemotherapy alone); day 1 of each cycle (q 2 weeks)
~Phase 1: 2 dose levels of MK-3475 Level -1: 50mg IV q 2 weeks Level 1: 75mg IV q 2 weeks Level 2: 200mg IV q 2 weeks
~Safety Expansion: MK-3475 at highest tolerated dose"
16085463|NCT02268747|Drug|Dacomitinib|"The patients will assume Dacomitinib 30 mg daily for the first 2 weeks. If the highest skin toxicity will be of grade <2, then the patients will start dacomitinib at 45 mg once daily and they will be clinically assessed every cycle (i.e. every 28 days).
~If the highest skin toxicity will be grade >2, then the patient will interrupt the treatment following the criteria for dose reduction."
16085464|NCT02268721|Device|Tablet computer|Patients receive a tablet computer upon discharge. The tablet can be used for ordering food for delivery three times a week from the hospital kitchen.
16085465|NCT02268708|Procedure|Oncological pulmonary resection|Respiratory evaluation before sugery Oncological pulmonary resection with general anesthesia. Hospitalization for post operative care
16085466|NCT02268695|Drug|Cisplatin|
16085467|NCT02268695|Drug|5-Fluorouracile|
16085468|NCT02268695|Drug|Docetaxel|
16085469|NCT02268695|Drug|Cetuximab|
16085470|NCT02268695|Drug|granulocyte colony-stimulating factor (G-CSF)|
16085471|NCT02268682|Other|Patient-Guided|"The Explore Transplant education program was designed to increase patient informed decision-making and knowledge and is based on the theoretical tenets of the Transtheoretical Model of Behavior Change. The program helps patients think about what might motivate them to pursue transplant, addresses commonly held concerns about transplant and involving a living donor, and shares real-life transplant stories of donors and recipients. The ET materials were written for patients with low health literacy. Already developed for the Explore Transplant program are brochures, videos, and factsheets. ET at Home is an expansion of the ET program. Newly designed postcards and text messages have added to the list of transplant education resources for this program."
16085472|NCT02268682|Other|Educator-Guided|The Transplant Educator supports the Explore Transplant at Home materials by facilitating a conversation about the content of the materials. The role of the Educator is filled by an experienced dialysis healthcare provider who can support a patient as they learn about their treatment options. The program is split into a series of four modules and the Educator conversations are guided by a Transplant Educator Guide and Patient Tracking Tool. This tool is intended to provide direct talking points for the Educator and is also a place where the patients' responses, questions, or concerns can be documented.
16085473|NCT02268669|Other|Reperfusion strategies|Two different reperfusion strategies in STEMI will be compared: primary angioplasty vs. post-thrombolysis angioplasty
16085474|NCT02268656|Drug|propofol|First subjects start from effect site concentraion of 5ug/ml propofol, after insertion of i-gel, determine the next subjects' effect site concentraion would be increae or decrease 0.5 ug/ml as up and down method
16085475|NCT02268643|Other|ultrasound plus clinical breast examination|all the participants will be required to fill risk factor questionaires and then be screened with ultrasound plus physical examination every year
16085476|NCT02268617|Other|Treadmill Walking|Following instructions and familiarization with the treadmill, participants will walk on the treadmill for 20 minutes total with rest periods as needed. Treadmill speed will be set at each participant's overground comfortable walking speed for the first 5 minutes, provided that they can walk safely. If necessary the speed will be lowered until a safe gait is achieved. After 5 minutes the speed will be incrementally increased by10% each 5 minutes (3 times) as long as a safe gait (i.e., no abnormal vital signs, excessive effort, or loss of balance occurrences) can be maintained. If the gait pattern becomes unsafe or more abnormal the speed will revert to the previous safe speed and be maintained at this level until the end of training session.
16085477|NCT02268604|Drug|BIIB 722 CL|
16085478|NCT02268604|Drug|Placebo|
16085479|NCT02268591|Device|Transcranial Stimulator|A non invasive brain stimulation which delivers low amplitude current through scalp electrodes by a Transcranial Stimulator
16085480|NCT02268578|Device|Transcranial Direct Current Stimulation|2mA tDCS
16085481|NCT02268578|Procedure|Sham Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation is administered but at 0mA
16085482|NCT02268565|Drug|Aspirin|81mg aspirin daily at bedtime over a 2 week period
16085483|NCT02268565|Drug|Placebo|pill that looks like aspirin without the effects of aspirin
16085484|NCT02268552|Drug|branaplam|
16085485|NCT02268539|Procedure|ablation|Ablation ranging from 20-25 watts / 30-45 seconds
16085486|NCT02268526|Biological|CSJ148|CSJ148 IV q 4weeks
16085487|NCT02268526|Drug|Placebo|Placebo IV q 4weeks
16085488|NCT02268500|Biological|Influenza vaccine|Influenza vaccine
16085489|NCT02268487|Drug|Sertraline|Treatment
16085490|NCT02268474|Device|Excel V 532nm (KTP) Laser or 595nm Pulse Dye Laser|Each subject's face will be divided in half and labeled as A (Right Side of the Face) or B (Left Side of Face). The allocation of treatment (532nm KTP laser) and active control treatment (595nm PDL) arms will be determined by randomization.
16085491|NCT02268461|Device|repetitive Transcranial Magnetic Stimulation (rTMS)|The treatment arm will consist of 3 daily treatment sessions. One treatment session in this study with real rTMS will consist of 600 pulses of 1Hertz rTMS at an intensity of 90% of resting motor threshold (duration 10 minutes) applied to the primary motor area of the contralesional hemisphere.
16085492|NCT02268461|Device|Sham repetitive Transcranial Magnetic Stimulation|Sham rTMS utilizes a coil that produces identical noise and tactile sensation to the real coil, but does not emit a magnetic field (0% intensity). Duration and frequency of auditory and tactile stimulation will be identical to the real intervention.
16085493|NCT02268448|Drug|Clonidine|
16085494|NCT02268448|Drug|Naltrexone|
16085495|NCT02268435|Drug|dovitinib plus imatinib|Dovitinib once daily on a 5 days on/2 days off dosing schedule, and imatinib once daily on a continuous dosing schedule
16085496|NCT02268422|Drug|Buprenorphine|7 day patch
16085497|NCT02268409|Drug|ACE-536|ACE-536 0.8 mg/kg once every 3 weeks by SC injection
16085498|NCT02268396|Drug|Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler|GFF MDI administered as 2 inhalations BID
16085499|NCT02268383|Drug|ACE-536|ACE-536 1.0 mg/kg once every 3 weeks by subcutaneous injection
16085500|NCT02268370|Drug|Dasatinib|
16085501|NCT02268357|Drug|Propranolol|Oral propranolol capsules
16085545|NCT02268032|Drug|DHEA|DHEA 2.2 g in vaginal ring
16085546|NCT02268032|Drug|Another Androgenic Agent (VRaA)|Testosterone 35 mg in vaginal ring
16085547|NCT02268032|Drug|Fixed combination of 2 androgenic agents (VR2A)|DHEA 1.5 g/testosterone 25 mg fixed combination in vaginal ring
16085502|NCT02268344|Device|Grass SD9 Stimulator|Electrical stimulation will be applied to the nerve using the Grass SD9 Stimulator at a frequency of 20Hz, 10-15V, for 60 minutes during the surgery. This will occur after the neck dissection has been completed, and the remainder of the surgery will continue during stimulation. The stimulation will be applied using the Grass SD9 Stimulator and the current will be conducted to the nerve using a sterile wire electrode that will be encircled around the nerve at its most proximally-exposed portion (skull base). The wire will be removed after 60 minutes of stimulation has been applied.
16085503|NCT02268331|Other|Active Surveillance|
16085504|NCT02268331|Other|Passive Surveillance|
16085505|NCT02268318|Other|1-Fermented Dairy Product with Phytosterols (test)|1- 1 bottle of test product/day
16085506|NCT02268318|Other|2-Fermented dairy Product with No Phytosterols (control)|2-1 bottle of control product/day
16085507|NCT02268305|Drug|MSM 1000mg twice a day (6000 mgs)|MSM is believed to have anti-inflammatory properties. MSM is a largely tasteless, odorless, white, crystalline solid which is water soluble. It occurs naturally in the environment and is synthesized in the human body as a byproduct of dietary DMSO.
16085508|NCT02268305|Other|Placebo capsules twice a day|Placebo is a capsule filled with rice flour.
16085509|NCT02268292|Behavioral|bicycle exercise|All enrolled subjects received a scheduled twelve-week exercise program. A commercially available bicycle (Giant CS800, Taichung, Taiwan) with an indoor bicycle stand (Giant Cyclotron Mag, Taichung, Taiwan) was used as the home exercise training modality.
16085510|NCT02268279|Drug|solithromycin|
16085511|NCT02268266|Device|Erigo|The control of cardiovascular parameters within suitable ranges for healthy and neurological patients using verticalization, leg mobilization and electrical stimulation
16085512|NCT02268253|Drug|SL-401|
16085513|NCT02268240|Behavioral|Stepped Care|Intervention will include : 1) care management; 2) cognitive-behavioral therapy (CBT); 3) psychiatric medication consultation in addition too receiving standard care through their medical team. Care management will include initial consultation to determine participants' and families' concerns and areas of difficulty, followed by brief interventions to connect them with care providers as needed . If participants do not show adequate symptom reduction, they will be engaged in structured CBT. CBT will be delivered in 4 to 12 structured sessions, each ranging from 30-60 minutes in length. Psychiatric medication consultation will be offered on an as-needed basis for participants not adequately responding to prior stepped care interventions. MD providers with expertise in psychopharmacological treatment of youth will provide consultation for participants' primary care provider regarding the prescription of psychiatric medications.
16085514|NCT02268214|Drug|Dapagliflozin|Tablets
16085515|NCT02268214|Drug|Placebo for dapagliflozin|Tablets
16085516|NCT02268201|Drug|Advagraf|oral
16085517|NCT02268201|Drug|Prograf|oral
16085518|NCT02268188|Other|education|Attend classes as part of Harvesting Health program
16085519|NCT02268188|Other|nutrition intervention|Learn how to incorporate nutrition guidelines into daily meal plans as part of Harvesting Health program
16085520|NCT02268188|Behavioral|exercise intervention|Use FitBit to log daily steps as part of Harvesting Health program
16085521|NCT02268188|Other|questionnaire administration|Ancillary studies
16085522|NCT02268188|Other|laboratory biomarker analysis|Correlative studies
16085523|NCT02268188|Other|quality-of-life assessment|Ancillary studies
16085524|NCT02268175|Drug|Enzalutamide|160 mg (four 40 mg capsules), oral, once daily, 28 days (4 weeks) 6 cycles maximum. Can be taken with or without food.
16085525|NCT02268175|Drug|Abiraterone Acetate|1000 mg (four 250 mg tablets), oral, once daily, 28 days (4 weeks) 6 cycles maximum. No food should be consumed for at least two hours before the dose and for at least one hour after the dose.
16085526|NCT02268175|Drug|Prednisone|5 mg, oral, once daily, 28 days (4 weeks) 6 cycles maximum.Take with food, preferred to be taken in the morning .
16085527|NCT02268175|Drug|Leuprolide Acetate|Either 7.5 mg monthly or 22.5 mg every three months, Intramuscular, monthly or every three months.
16085528|NCT02268162|Procedure|guiding equipments|The guiding equipments including VBN, EBUS-GS and fluoroscopy guide a bronchoscope along the bronchial route to a peripheral pulmonary lesion.
16085529|NCT02268149|Drug|BIIL 284 BS|
16085530|NCT02268149|Drug|Prednisone|
16085531|NCT02268149|Drug|Placebo|
16085532|NCT02268136|Drug|BIII 890 CL|
16085533|NCT02268136|Drug|Placebo|
16085534|NCT02268110|Other|Exercise therapy|Supervised exercise therapy with a 12 week progressive abdominal exercise home program for
16085535|NCT02268110|Other|Abdominal binding|Wearing an abdominal binder for 12 weeks
16085536|NCT02268097|Procedure|Patellar resurfacing with freehand technique|Preparing patellar resurfacing during total knee arthroplasty with freehand
16085537|NCT02268097|Procedure|Patellar resurfacing with resection guide technique|Preparing patellar resurfacing during total knee arthroplasty with a resection guide
16085538|NCT02268084|Device|Magnetic EEG/ECG-guided Resonance Therapy|A coil delivers a pulsed magnetic field to the cortex of the brain
16085539|NCT02268084|Device|Sham|Sham coil simulates behavior of the intervention magnetic coil without applying the magnetic field
16085540|NCT02268071|Drug|Antihypertensive treatment will be stopped for 1 year unless hypertension recurrence|For patients with average of HBPM values <135/85mmHg at baseline, the antihypertensive treatment will be stopped for 1 year (half dose for 3 days then interruption)
16085541|NCT02268058|Drug|Acetaminophen|routine administration of medication for a 72 hour period
16085542|NCT02268058|Drug|Ibuprofen|routine administration of medication for a 72 hour period
16085543|NCT02268045|Biological|RTXM83|Rituximab biosimilar (RTXM83) will be administered in combination with CHOP chemotherapy regimen (Cyclophosphamide 750 mg/m2, Doxorubicin 50 mg/m2 and Vincristine 1.4 mg/m2 up to a maximum of 2 mg on Day 1 plus Prednisone 40 mg/m2 or 100 mg per day from Day 1 to 5) at a dose of 375 mg/m2 on Day 1 of each 3 week cycle, for 6 cycles, although the administration of 2 additional cycles may be allowed.
16085544|NCT02268045|Biological|Mabthera|Mabthera will be administered in combination with CHOP chemotherapy regimen (Cyclophosphamide 750 mg/m2, Doxorubicin 50 mg/m2 and Vincristine 1.4 mg/m2 up to a maximum of 2 mg on Day 1 plus Prednisone 40 mg/m2 or 100 mg per day from Day 1 to 5) at a dose of 375 mg/m2 on Day 1 of each 3 week cycle, for 6 cycles, although the administration of 2 additional cycles may be allowed.
16085548|NCT02268019|Procedure|tourniquet application|
16085549|NCT02268019|Drug|epinephrine injection|
16085550|NCT02268006|Radiation|IMRT-SIB|
16085551|NCT02268006|Drug|Capecitabine|
16085552|NCT02268006|Procedure|Surgery|
16085553|NCT02267993|Drug|recombinant human thrombopoietin|Patients received subcutaneous injection of recombinant human thrombopoietin at a dose of 300 U/kg body weight once daily at a platelet count of < 50×109/L, and recombinant human thrombopoietin treatment ceased at a platelet count of ≥20×109/L if platelet is not transfused.
16085554|NCT02267980|Drug|Sevoflurane|Inhalation anesthetic agent
16085555|NCT02267980|Drug|Ketamine|Intravenous anesthetic agent
16085556|NCT02267980|Drug|Saline|Isotonic solution for placebo group
16085557|NCT02267967|Drug|Sulfatinib|Sulfatinib 300 mg once a day (QD) will be orally administrated on a 28-day cycle.
16085558|NCT02267954|Other|Menu edited|The menu is edited to change price label to 50% of actual value and calorie label to 50% of the actual value, along with other changes.
16085559|NCT02267941|Other|observation|Data were collected by a disigned form. Statistic software was used to analyze clinical data.
16085560|NCT02267928|Other|Check Symptoms|"Symptoms are Checked"
16085561|NCT02267928|Other|Uncheck Symptoms|"Symptoms are Un-checked"
16085562|NCT02267928|Other|Experienced|Focus of instructions is on symptoms the participant has experienced
16085563|NCT02267928|Other|Not Experienced|Focus of instructions is on symptoms the participant has NOT experienced
16085564|NCT02267915|Drug|subcutaneous Rituximab|MabThera 1400 mg solution for subcutaneous injection
16085565|NCT02267902|Drug|DA-1229|
16085566|NCT02267889|Procedure|Image guided GP ablation|3D imaging data from the D-SPECT system will be used to visualise the GP and guide the location of catheter ablation sites during the electrophysiology procedure.
16085567|NCT02267889|Device|D-SPECT dedicated cardiac nuclear camera|
16085568|NCT02267876|Device|BD HPV Assay on Viper LT|The BD HPV specimen will be tested with the BD HPV Assay on the Viper LT instrument.
16085569|NCT02267876|Procedure|Colposcopy|The colposcopy will be performed on subjects that have abnormal cytology. At the third year visit all subjects will have an exit colposcopy.
16085570|NCT02267863|Drug|APTO-253|APTO-253 will be given in ascending doses starting at 20 mg/m2 until the maximum tolerated dose or recommended dose is reached.
16085571|NCT02267850|Other|Fixed Orthodontic Appliance Treatment|Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.
16085572|NCT02267850|Device|OrthoPulse™|Patients carry out daily OrthoPulse™ treatments at home.
16085573|NCT02267850|Device|Non-Functional OrthoPulse™|Patients carry out daily sham-OrthoPulse™ treatments at home. This is a non-functional device so patients do not receive photobiomodulation therapy.
16085574|NCT02267837|Device|OrthoPulse™|Patients carry out daily OrthoPulse™ treatments at home.
16085575|NCT02267824|Device|Extraoral OrthoPulse® PBM|Patients carry out daily extraoral OrthoPulse® PBM treatments at home.
16085576|NCT02267824|Other|Fixed Orthodontic Appliance Treatment|Patients are treated for full mouth fixed orthodontic appliance treatment by the qualified Principal Investigator (PI). Orthodontic treatment procedures carried out per the traditional practices of the PI and dental office.
16085577|NCT02267811|Other|Orthodontic Treatment|Patients are treated for orthodontic treatment by the qualified Principal Investigator (PI). Treatment and follow-up appointments per the traditional practices of the PI and dental office.
16085578|NCT02267811|Device|OrthoPulse™|Participants carry out daily OrthoPulse™ treatments at home.
16085579|NCT02267798|Other|conventional therapy|"The conventional rehabilitation program will consist of physiotherapy sessions (100 min/day) following an individualized approach. The program aims at the restoration of mobility and daily living competence. Specific exercises for the affected upper limb will include, bilateral tasks and facilitation techniques.
~The amount of treatment will to be comparable between control and experimental groups in order to avoid possible confounding factors."
16085580|NCT02267798|Device|arm training combined with FES|"Arm training protocol Training sessions will last for 60 minutes. The Reo Therapy System is robot-assisted therapy; during the session the subject's affected hand is placed on or strapped onto a robotic arm and the subject is instructed to either actively reach predefined reach points, or to be guided while the robotic arm leads the arm towards these reach points.
~Functional electrical stimulation protocol Experimental group will receive up to 40 minutes of FES after arm training. The device consists is a stimulator containing 5 electrodes positioned to provide reliable activation of the following muscles: extensor digitatum communis and extensor pollices brevis, flexor pollices longus, flexor digitatum superficialis, and thenar muscles."
16085581|NCT02267785|Other|Skill-Based Exercise|The skill-based exercise program is designed to improve skilled function, fine and gross- motor body coordination. The intervention will be focused on acquisition and improvement of complex movements for the whole body and include the following general categories of activities: (1) balance, (2) eye-hand coordination, (3) leg-arm coordination; 4) reaction time to moving objects/persons; (5) dynamic gait and 6) functional activity performance. The treating therapist will direct both general principles of progression and progression specific to each category.
16085582|NCT02267785|Other|Aerobic Exercise|The aerobic cardiovascular exercise will consist of 36 1-hour sessions performed 3 times weekly over 12 weeks. Aerobic exercise will consist of cycling on a recumbent stationary bicycle. Each session will begin and end with gentle stretching. Continuous cycling will be performed for 45-50 minutes, with the first and last 5 minutes designated as warm-up and cool-down periods. The intensity of the middle 30 minutes of cycling will be increased progressively from an initial target of 50% maximum heart rate (HR) during week 1 to 75% of maximum HR by week 12. The initial intensity will be set at 50% of maximum HR. Participants will be encouraged to cycle as fast as they can, with a goal of maintaining 90 revolutions per minute (RPM) throughout the middle 30-minute period. Pedaling resistance will be kept low throughout all sessions. Measures of heart rate via heart rate monitors, blood pressure, RPM, and rate of perceived exertion will be recorded at 5-minute intervals.
16085699|NCT02266953|Behavioral|Treatment as usual|The public health nurses at child health centres in control municipalities are performing consultations at the child health centres as usual and without using the particular communication tool about diet.
16085583|NCT02267785|Other|Social Contact|The control Social Contact group will consist of an equal amount of social contact as the exercise group. Subjects will have weekly visits at the University of Southern California with the study coordinator. The goal is for 3 hours of social contact every week for a total of 36 hours over 12 weeks. Activities scheduled for the social contact visits will include: (1) support group interactions and (2) social outings such as a trip to a museum, local café for lunch or dinner; (3) book club; (4) sports event. Support group interaction can include discussions among patients and caregivers, presentations from experts in various aspects of PD. They will be instructed to continue with their usual level of activity but refrain from beginning new exercise activities during the study period.
16085584|NCT02267772|Drug|IV Acetaminophen|IV Acetaminophen
16085585|NCT02267772|Drug|IV Morphine|IV Morphine
16085586|NCT02267759|Device|McGrath videolaryngoscopy|After the softened nasotracheal tube was inserted into the nares until its tip passed through the posterior nares, McGrath videolaryngoscope was introduced into the mouth and the nasotracheal tube was advanced.
16085587|NCT02267759|Device|Macintosh laryngoscopy|After the softened nasotracheal tube was inserted into the nares until its tip passed through the posterior nares, Macintosh laryngoscope was introduced into the mouth and the nasotracheal tube was advanced.
16085588|NCT02267746|Drug|Tazarotene (Fabior™)|
16085589|NCT02267746|Drug|Tazarotene (Actavis)|
16085590|NCT02267746|Drug|Vehicle foam|
16085591|NCT02267733|Drug|Fluzone|Fluzone High-Dose will be administered with a planned booster at 30 days post initial administration
16085592|NCT02267720|Procedure|Occlusal-proximal ART restorations - Ketac Molar|Occlusal-proximal ART restorations - Ketac Molar
16085593|NCT02267720|Procedure|Occlusal-proximal ART restorations - Vitro Molar|Occlusal-proximal ART restorations - Vitro Molar
16085594|NCT02267707|Drug|nab-paclitaxel|Subjects will receive nab-paclitaxel as an intravenous infusion over approximately 30 minutes on Days 1, 8 and 15 of a 28-day cycle.
16085595|NCT02267707|Drug|Gemcitabine|Gemcitabine will be administered immediately after nab-paclitaxel as an intravenous infusion over approximately 30 minutes on Days 1, 8 and 15 of a 28-day cycle.
16085596|NCT02267694|Drug|Freeze-dried black raspberry powder|
16085597|NCT02267681|Drug|Fentanyl|Intravenous fentanyl for sedation/analgesia
16085598|NCT02267681|Drug|Alfentanil|Intravenous alfentanyl for sedation/analgesia
16085599|NCT02267681|Drug|Propofol|Intravenous propofol for sedation
16085600|NCT02267668|Behavioral|STEP|Physical therapists guide participants through novel set of assigned exercises
16085601|NCT02267668|Behavioral|Control|Participants self-guide through standard exercises
16085602|NCT02267655|Drug|inhaled Nitric Oxide - 30 mcg/kg IBW/hr|inhaled Nitric Oxide in 30 mcg/kg IBW/hr doses Part 1
16085603|NCT02267655|Drug|inhaled Nitric Oxide 5,10,15 mcg/Kg IBW/hr|inhaled inhaled Nitric Oxide 5,10,15 mcg/Kg IBW/hr dose titration
16085604|NCT02267655|Drug|inhaled nitric oxide 75 mcg/kg IBW/hr|inhaled nitric oxide 75 mcg/kg IBW/hr -Part 2b
16085605|NCT02267642|Biological|AbGn-168H|monoclonal antibody
16085606|NCT02267629|Drug|Rapastinel (formerly GLYX-13)|10 mg/kg IV Rapastinel (formerly GLYX-13)
16085607|NCT02267616|Device|Etonogestrel Implant|Subdermal arm implant
16085608|NCT02267603|Other|Laboratory Biomarker Analysis|Ancillary studies
16085609|NCT02267603|Biological|Pembrolizumab|Given IV
16085610|NCT02267577|Device|Sphygmo: Automatic Blood Pressure Monitor|A team of engineers from Rice University has recently developed Sphygmo, an ambulatory, low-cost blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals.
16085611|NCT02267577|Device|GE Dinamap ProCare Automatic Blood Pressure Monitor|This commercially available gold standard blood pressure monitor will be used as a control to assess the accuracy of the Sphygmo device.
16085612|NCT02267564|Procedure|MPFL reconstruction|to correct patellar dislocation with medial patellofemoral ligament reconstruction
16085613|NCT02267564|Procedure|tibial tubercle transfer|to correct patellar dislocation with tibial tubercle medial transfer
16085614|NCT02267551|Other|Mimic dv-Trainer|
16085615|NCT02267551|Other|daVinci Skills Simulator|
16085616|NCT02267538|Drug|dexmedetomidine hydrochloride for injection|"Before anesthesia, dexmedetomidine hydrochloride for injection (200 ug/2 ml) will be diluted with normal saline to 50 ml (final dexmedetomidine concentration 4 ug/ml).
~Before the induction of anesthesia, a loading dose will be administered by intravenous infusion at a rate of [0.9*kg] ml/h for 10 minutes (i.e., dexmedetomidine 0.6 μg/kg in 10 minutes), followed by continuous infusion at a rate of [0.1*kg] ml/h (i.e., dexmedetomidine at a rate of 0.4 μg /kg/h) until the end of surgery.
~At the end of surgery, the infusion rate will be decreased to [0.025*kg] ml/h (i.e., dexmedetomidine at a rate of 0.1 ug/kg/h) and continued until the end of mechanical ventilation after surgery."
16085617|NCT02267538|Drug|0.9% sodium chloride for injection|"Before anesthesia, 0.9% sodium chloride for injection 50 ml will be prepared.
~Before the induction of anesthesia, a loading dose will be administered by intravenous infusion at a rate of [0.9*kg] ml/h for 10 minutes, followed by continuous infusion at a rate of [0.1*kg] ml/h until the end of surgery.
~At the end of surgery, the infusion rate will be decreased to [0.025*kg] ml/h and continued until the end of mechanical ventilation after surgery."
16085618|NCT02267525|Drug|Velusetrag|
16085619|NCT02267525|Drug|Placebo|
16085620|NCT02267512|Drug|ATG-F|Intravenous (IV)
16085621|NCT02267499|Other|LLM training|Participants use the FitForAll exergaming computer platform as the physical training component (PTC); Participants use the language adapted Version of the BrainFitness Program as the cognitive training component (CTC)
16085622|NCT02267486|Other|Standard therapy of Alzheimer Dementia (AD)|
16085623|NCT02267486|Other|Observation|
16085624|NCT02267460|Biological|AA4500|
16085625|NCT02267460|Device|ErecAid® Esteem® Manual Vacuum Therapy System|
16085626|NCT02267460|Procedure|Investigator Modeling|
16085627|NCT02267434|Biological|Low dose AFFITOPE® PD03A + Adjuvant|s.c. injection
16085628|NCT02267434|Biological|High dose AFFITOPE® PD03A + Adjuvant|s.c. injection
16085629|NCT02267434|Biological|Adjuvant without active component|s.c. injection
16085630|NCT02267421|Behavioral|Home based Aerobic exercise training|
16086295|NCT02262624|Drug|Hydrochlorthiazide (HCTZ)|
16085631|NCT02267408|Other|Warfarin adjustment using the Fearon algorithm|All available historical data will be used to calculate with the Fearon algorithm the individual sensitivity to warfarin and to dose changes as well as lag time until a dose adjustment reaches full effect. Based on this a personal dosing nomogram will be developed and provided to the investigator and to the patients. This nomogram will be used during 6 month but override is possible if the investigator feels that the suggestion from the nomogram is unsafe.
16085632|NCT02267408|Other|Warfarin adjustment using standard dosing|Patients will receive warfarin dosing instructions from a trained nurse using fixed nomograms and computer-based dosing suggestion.
16085633|NCT02267395|Other|(1) cranio-cervical flexion test;|Test to determine level of strength for Deep Neck Flexor muscles
16085634|NCT02267395|Other|(2) scapular dyskinesis test|Test to determine scapular control
16085635|NCT02267395|Other|(3) deep neck flexor endurance test.|Test do determine endurance for the deep neck flexor muscle group.
16085636|NCT02267382|Drug|VT-1161|
16085637|NCT02267382|Drug|Placebo|
16085638|NCT02267369|Behavioral|Media-assisted fitness program|Participants can register workshops online, track program participation, and receive promotional health messages online.
16085639|NCT02267369|Behavioral|Social network-assisted fitness program|Participants can register workshops online and track program participation. Participants are put into anonymous online social networks and receive real-time activity updates from 4-6 peers.
16085640|NCT02267369|Behavioral|Basic fitness program|Participants can register workshops online and track program participation.
16085641|NCT02267356|Drug|VT-1161|
16085642|NCT02267356|Drug|Placebo|
16085643|NCT02267343|Drug|ONO-4538|
16085644|NCT02267343|Drug|Placebo|
16085645|NCT02267330|Procedure|Exposure Recording|Patient undergoing fracture surgery will have radiation exposure recorded
16085646|NCT02267317|Drug|Eritoran|Pharmacologic inhibitor of TLR4 receptors.
16085647|NCT02267317|Drug|D5W|5% Dextrose Water = Vehicle
16085648|NCT02267304|Drug|50 mL of sodium chloride (0,9%)|
16085649|NCT02267304|Drug|Morphine 0,05mg/kg|
16085650|NCT02267304|Drug|Naloxone 10mg|
16085651|NCT02267291|Other|Non-invasive positive pressure ventilation|Ventilatory support to alter intrathoracic pressure
16085652|NCT02267278|Drug|Ruxolitinib|Ruxolitinib taken by mouth 2 times each day in a 28-day cycle. Patients receive Ruxolitinib alone for first 3 months, and then Pracinostat added. Starting dose of Ruxolitinib based on patients' platelet count. Dose of Ruxolitinib may be increased or decreased at discretion of treating physician prior to initiation of Pracinostat.
16085653|NCT02267278|Drug|Pracinostat|Starting dose of Pracinostat 60 mg by mouth 1 time each day for 3 alternating days every 3 weeks starting on Day 1 of Cycle 4.
16085654|NCT02267278|Behavioral|Questionnaire|Questionnaire regarding quality of life completed at baseline, within 3 days before Day 1 of Cycles 1 - 6, and then every 3 cycles after that.
16085655|NCT02267265|Other|TMW-Newborn Intervention video|This is an educational video intervention developed by the Thirty Million Words® Initiative Lab.
16085656|NCT02267265|Other|Safe Sleep for your Baby (SIDS) educational video|It is an educational video developed by the National Institute of Child Health and Development (NICHD) promoting the prevention of Sudden Infant Death Syndrome.
16085657|NCT02267252|Other|Antibody-sperm binding|
16085658|NCT02267239|Drug|essential oils, immersion|A single, 30-second immersion in 1 mL of essential oils in a hydroalcoholic solution (Listerine Mentol, Listerine®, Johnson & Johnson, Madrid, Spain) (I-EO).
16085659|NCT02267239|Drug|Chlorhexidine, immersion|A single, 30-second immersion in 1 mL of 0.2% chlorhexidine (Oraldine Perio®, Johnson and Johnson, Madrid, Spain) (I-0.2% CHX).
16085660|NCT02267239|Drug|essential oils, mouthwash|A single, 30-second mouthwash with 20 mL of essential oils in a hydroalcoholic solution (Listerine Mentol, Listerine®, Johnson & Johnson, Madrid, Spain) (M-EO).
16085661|NCT02267239|Drug|chlorhexidine, mouthwash|A single, 30-second mouthwash with 10 mL of 0.2% chlorhexidine (Oraldine Perio®, Johnson and Johnson, Madrid, Spain) (M-0.2% CHX).
16085662|NCT02267239|Procedure|professional oral cleaning|scaling and polishing teeth of the volunteers
16085663|NCT02267239|Procedure|Plaster cast|Taking a plaster cast of the volunteers' mouth
16085664|NCT02267239|Device|IDODS|Specific intraoral device which carries six glass disks
16085665|NCT02267226|Drug|Octafibrin|
16085666|NCT02267213|Drug|Lipotecan|Administer 40mg Lipotecan at D1, D8, D15 of each cycle.
16085667|NCT02267187|Procedure|Fat Grafting|Fat Grafting is a procedure that involves moving a person's own fat from an area of the body where it is less needed to another area of the body to improve its appearance. The fat is usually taken from the thighs or abdomen with a small liposuction tube and then moved to an area that has lost volume or fullness due to aging, trauma, surgery, birth defects, or other causes.
16085668|NCT02267187|Drug|General Anesthesia|A medicine that will relax and assist the subject in keeping unconscious (in a sleep like state) during the entire procedure.
16085669|NCT02267187|Device|Coleman Cannulas|The plastic surgeon, will use small narrow tube-like instruments called cannulas, will remove fat from various places throughout the body (commonly the abdomen and thighs). The plastic surgeon will then use the Coleman cannulas (specialized smaller cannulas with varied shapes and tip sizes specifically made to deliver smaller amounts of fat) to fill the desired area.
16085670|NCT02267187|Other|Tefla non-adherent gauze pad|The processing of the fat graft material is done using a Tefla non-adherent gauze pad in a rolling technique that separates the aqueous and oil layers from the injected component.
16085671|NCT02267174|Behavioral|Standardized handoff|A standardized handoff will be implemented that consists of choreographed handoffs utilizing a structured handoff tool to facilitate information exchange.
16085672|NCT02267161|Other|Psychometric scales for infants at 3 years of age|WPPSI-III, VINELAND, CBCL, NEPSY
16085700|NCT02266940|Drug|DS-1971a suspension|DS 1971a will be supplied as a powder or crystals and prepared at the study site for administration as an oral suspension with a taste masking agent.
16085701|NCT02266940|Drug|DS-1971a tablet|A 200 mg DS 1971a tablet for oral administration
16085702|NCT02266927|Drug|Flovent HFA|
16085703|NCT02266927|Drug|OPTINOSE™ FLUTICASONE|
16085781|NCT02266381|Procedure|Fluoroscopy-guided renal access|Patients undergo MPCNL using only fluoroscopy-guided renal access.
16085673|NCT02267135|Biological|Secukinumab 300 mg|Secukinumab 300 mg will be provided in 1 mL prefilled syringes of 150 mg. Each dose of 300 mg secukinumab will consist of two secukinumab 150 mg injections once weekly for 5 weeks (Baseline, Weeks 1, 2, 3 and 4), followed by dosing every four weeks starting at Week 8 through Week 20 inclusive. In order to maintain the blinding, patients will receive additional placebo injections at Weeks 13, 14 and 15. The patients (or caregivers) will self-inject each dose at the study site under the supervision of site personnel when injections occur of days of study visits. The injections not occurring during a study visit will be done by the patients (or caregivers) at home.
16085674|NCT02267135|Biological|Placebo|Placebo will be provided in 1 mL prefilled syringe. Each placebo dose will consist of two placebo injections once weekly for five weeks (Baseline, Weeks 1, 2, 3 and 4), then after four weeks at Week 8. At Week 12, PSSI responders will continue on placebo and receive their injections once weekly for five weeks (Weeks 12, 13, 14, 15 and 16), then followed by dosing after four weeks at Week 20. PSSI non-responders will be switched to receive 300 mg secukinumab at Weeks 12, 13, 14, 15 and 16, then after four weeks at Week 20. The patients (or caregivers) will self-inject each dose at the study site under the supervision of site personnel when injections occur on days of study visits. The injections not occurring during a study visit will be done by the patients (or caregivers) at home.
16085675|NCT02267122|Procedure|ionic silver-containing dressing|After placing the staples, a ionic silver-containing dressing was placed covering the wound
16085676|NCT02267122|Procedure|Mupirocin ointment application|After placing the staples, Mupirocin ointment application over the wound was performed
16085677|NCT02267109|Biological|Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z|IM injection of Ebola Chimpanzee Adenovirus Vector Vaccine (cAd3-EBO Z):
16085678|NCT02267109|Biological|Booster-MVA-BN® Filo or saline placebo|IM injection of Booster-MVA-BN® Filo or saline placebo
16085679|NCT02267096|Behavioral|Telephone Counseling|The TC arm includes a stepped care approach, 3-6 phone sessions, depending on each participant's needs. Within 1-2 days post-T1 assessment, the intervention will begin. Sessions 1-3 (15 min each) will occur approximately weekly over 3-4 weeks, scheduled at participants' convenience and at strategic therapeutic times (e.g., shortly pre/post-quit date). Continuing smokers or newly quit former smokers who would benefit from relapse prevention sessions will receive up to 3 additional sessions, to be completed within 3-4 weeks. The provision of 3-6 sessions is more intensive than several other telephone counseling interventions. A dose response relationship between quitting and number of sessions has been shown in non-volunteer smokers, and based on our pilot data, the investigators expect that a more intensive intervention will be needed for some participants.
16085680|NCT02267096|Behavioral|Minimal Treatment|A list of self-help materials (print-, web-, phone-based), the national telephone quitline phone number, and local in person cessation resources will be given to all participants.
16085681|NCT02267083|Drug|GPX-150 for Injection|GPX-150 at a starting dose of 265 mg/m2 every 21 days for 16 cycles or until death, disease progression, or unacceptable toxicity. The dose of GPX-150 may be reduced by 25% if any dose reduction criteria are met. Two reductions are allowed per subject during the course of the study.
16085682|NCT02267070|Behavioral|Case management and supportive psychotherapy|An individual therapist will provide weekly case management and therapy targeting the individual psychological problems and everyday functioning needs of the patient
16085683|NCT02267070|Behavioral|Family psychoeducation|All immediate family members will be invited to family psychoeducation sessions.
16085684|NCT02267070|Behavioral|Cognitive training|The Cognitive Training and Exercise intervention involves 24 weeks of systematic computerized cognitive training, 4 hours per week, plus aerobic exercise, four 30 minute sessions per week. The first 12 weeks involves neurocognitive training, using auditory training exercises from Posit Science Brain HQ. The second 12 weeks involves social cognitive training, using the Posit Science SocialVille modules. A weekly one-hour Bridging Skills Group with other members of the treatment condition is designed to aid generalization of training to everyday life situations.
16085685|NCT02267070|Behavioral|Aerobic exercise|Aerobic exercise occurs as two 30-minute sessions at the clinic and two at home weekly. Intensity of aerobic exercise is tailored to maintain an individualized target heart rate zone and is monitored by a heart rate recorder.
16085686|NCT02267057|Drug|Paracetamol|Paracetamol granulate supplied by Weifa (Paracet) and 1 g paracetamol tablets produced by Kragerø tablettproduksjon for blinding purposes.
16085687|NCT02267057|Drug|Buprenorphine|Buprenorphine 5 micrograms/hour and 10 micrograms/hour transdermal system produced by Mundipharma, identical to placebo transdermal system.
16085688|NCT02267057|Drug|Paracetamol placebo|Paracetamol placebo tablets produced by Kragerø tablettproduksjon.
16085689|NCT02267057|Drug|Buprenorphine placebo|Buprenorphine transdermal system placebo produced by Mundipharma.
16085690|NCT02267044|Drug|Ropivacaine|The drug used for the interscalene blocks
16085691|NCT02267031|Procedure|mechanical ventilation|"Patients subjected to scheduled laparoscopic cholecystectomy were enrolled to the ongoing prospective study and randomized into four groups: 1) normoxia and normocapnia (nO2-nCO2), 2) hyperoxia and normocapnia (hO2-nCO2), 3) normoxia and hypocapnia (nO2-lCO2), and 4) hyperoxia-hypocapnia (hO2-lCO2).
~Normoxia PaO2 was referred to PaO2 of 70-140 mm Hg, hyperoxia 150-300 mm Hg, normocapnia PaCO2 of 35-48 mmHg and hypocapnia PaCO2 of 25-35 mmHg."
16085692|NCT02267018|Device|Drager VN500 Ventilator|This ventilator is capable of providing both nCPAP and NIHFV support.
16085693|NCT02267005|Dietary Supplement|Creapure|Patients will be prescribed a creapure supplement by weight, to be taken 3x/day for the duration of the trial. They will be randomized to an active product start time using a multiple baseline design.
16085694|NCT02267005|Dietary Supplement|Glucose Tablet|Patients will be prescribed the placebo supplement by weight, to be taken 3x/day for the duration of the trial. They will be randomized to an active product start time using a multiple baseline design.
16085695|NCT02266992|Biological|Live attenuated Vaccine- Fluenz Tretra|Intra-nasal administration of 0.2ml (0.1ml in each nostril).
16085696|NCT02266966|Drug|F2695|
16085697|NCT02266966|Drug|Placebo|
16085698|NCT02266953|Behavioral|Use of communication tool about diet|The experimental intervention comprise the public health nurse's use of an image based communication tool in her dialogue with the family. This is in order to act in a patient centered way to facilitate participation by the parents and focus on relevant food and feeding practices from the parents' point of view.
16086296|NCT02262624|Drug|Telmisartan/HCTZ fixed combination|
16085704|NCT02266914|Device|Magnetic Resonance Elastography driver|A driver is required for MRE. The driver utilizes sound waves to produce vibrations. Images of these vibrations are captured with Magnetic Resonance scanner to produce images that indicate stiffness in an organ.
16085705|NCT02266901|Procedure|endoscopic drainage|Endoscopic percutaneous access was obtained through surgical drains or after ultrasound-guided percutaneous drainage with a thin scope , and transluminal procedures with large scopes through the leak hole. All the procedures were performed under general anesthesia and carbon dioxide insufflation. Debridement was done by pus aspiration and irrigation.
16085708|NCT02266875|Drug|hypertonic saline|
16085709|NCT02266875|Drug|standard saline|
16085710|NCT02266862|Radiation|Study group|Patients will receive an additional CT sequence (end-expiration) at the time of their standard CT imaging before and after the repair.
16085711|NCT02266849|Drug|Loperamide|12 mg Loperamide each day for three days
16085712|NCT02266849|Drug|Placebo|6 tablets daily for three days
16085713|NCT02266836|Device|MyndMove|During a MyndMove therapy session, the patient is instructed to attempt to execute a task voluntarily. As the patient is attempting to perform the designated task, specific muscles in the arm are stimulated to generate contractions that produce the desired movement. After a brief interval of the patient attempting to initiate a movement the therapist activates the MyndMove stimulation protocol, which generates bursts of short electrical pulses, using surface electrodes, to produce muscle contractions enabling the patient to complete the desired/instructed task. Proper sequencing of the muscle contractions as per the MyndMove protocols are tailored to achieve a wide range of reaching and grasping functions. The technique stimulates non-damaged pathways of the central nervous system.
16085714|NCT02266823|Behavioral|Social Cognitive Theory|The intervention, which combines behavioral counseling with mobile self-monitoring, will be based on SCT which focuses on the role played by self-referent thought in the maintenance of behavior change. Within SCT, behavior change and maintenance are influenced strongly by the individual's perceived self-efficacy.
16085715|NCT02266810|Device|PROPEL Mini Sinus Implant.|Placement of sinus implant following frontal sinus surgery
16085716|NCT02266810|Procedure|Sinus Surgery alone|Sinus surgery only, without implant placement
16085717|NCT02266810|Device|Propel Nova Sinus Implant|Placement of sinus implant following frontal sinus surgery
16085718|NCT02266797|Drug|Dexamethasone|The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.
16085719|NCT02266797|Other|Saline|The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose.
16085720|NCT02266784|Behavioral|Contingency Management (CM)|
16085721|NCT02266784|Drug|Transdermal nicotine skin patches (i.e. Habitrol)|
16085722|NCT02266784|Other|Supportive Counseling|
16085723|NCT02266771|Device|NPWT with Instillation|Kinetic Concepts Inc. V.A.C Ulta Negative Pressure Wound Therapy System with V.A.C. VeraFlo Instillation
16085724|NCT02266771|Device|NPWT|Kinetic Concepts Inc. V.A.C Ulta Negative Pressure Wound Therapy System
16085725|NCT02266758|Other|GDM Screening Methods|
16085726|NCT02266745|Drug|PT-112 Injection|
16085727|NCT02266732|Device|Stimuplex HNS 12|
16085728|NCT02266719|Device|Fenestrated CMD|"The CMD that will be used in this IDE is structurally the same as the commercially available Zenith Fenestrated AAA Endovascular Graft.
~In general, the Zenith® Fenestrated AAA Endovascular Graft is a modular system constructed of full- thickness woven polyster fabric sewn to self-expanding stainless steel z-stents with braided polyster and monofilament polypropylene sutures. In this study, fenestrated grafts with usually up to 4 fenestrations may be used.
~Device implantation will be performed using standardized endosvacular techniques used in the treatment of abdominal aortic aneurysms."
16085729|NCT02266719|Device|Type I - III TAAA|"Device implantation will be performed using standardized endosvacular techniques used in the treatment of abdominal aortic aneurysms. Devices will be implanted in patients with type I-III thoracic abdominal aneurysms.
~The branches in this study will be constructed as internal/external cuffs, axially oriented and caudally or cranially directed, as necessary . Branch position will be determined by the anatomic location of the target vessels using a consistent craniocaudal and circumferential cuff position."
16085730|NCT02266719|Device|Arch cohort|Arch branched devices may be designed using one of two configurations: (1) Zone 0 device with two inner antegrade branches for the innominate artery and the left common carotid artery with or without a retrograde left subclavian artery branch and (2) Zone 1-2 device with a single retrograde subclavian artery branch with double or triple wide scallop for the left common carotid artery. These devices are designed for a of proximal landing/fixation zone of at least 20 mm of healthy aortic segment or a previous graft.
16085731|NCT02266706|Drug|Ceftolozane/Tazobactam 1000/500 mg|A fixed dose combination (FDC) of 1000 mg ceftolozane and 500 mg tazobactam as a 60 minute infusion.
16085732|NCT02266706|Drug|Ceftolozane/Tazobactam 30/15 mg/kg|A FDC of 30 mg/kg of ceftolozane and 15 mg/kg of tazobactam as a 60 minute infusion.
16085733|NCT02266706|Drug|Ceftolozane/Tazobactam 20/10 mg/kg|A FDC of 20 mg/kg of ceftolozane and 10 mg/kg of tazobactam as a 60 minute infusion.
16085734|NCT02266706|Drug|Ceftolozane/Tazobactam 18/9 mg/kg|A FDC of 18 mg/kg of ceftolozane and 9 mg/kg of tazobactam as a 60 minute infusion.
16085735|NCT02266706|Drug|Ceftolozane/Tazobactam 12/6 mg/kg|A FDC of 12 mg/kg of ceftolozane and 6 mg/kg of tazobactam as a 60 minute infusion.
16085736|NCT02266693|Behavioral|iCBT|The iCBT program consists of weekly online lessons, weekly homework assignments, regular automatic email reminders about lessons and homework, weekly contact via phone or email with a CBT therapist, and access to a large online library of written resources about depression and anxiety and application of CBT skills. The CBT therapist contacts all participants once a week to review lessons, assist patients with treatment difficulties, reinforce progress and encourage continued engagement with the program. Therapist-patient contact is limited to 10 minutes per patient per week.
16085780|NCT02266381|Procedure|US-guided renal access|Patients undergo MPCNL using only US-guided renal access.
16085737|NCT02266680|Behavioral|Yoga Treatment Group|The breathing focused yoga intervention is a manualized yoga protocol developed at CAMH by the Mood and Anxiety Disorders group, with yoga teacher, Ms. Tiffany Garfinkel, as the lead. BFY incorporates postures and meditation, but there is a special focus on controlled breathing at different rates, including Ujjaji or slow inhalation, exhalation and holding of breath; Bhastrika or Kapalabhati, two types of vigorous breathing with forced exhalation; and cyclical breathing or a repeated pattern of slow, moderate and fast breathing.
16085738|NCT02266667|Device|2 NEMOST rods : bilateral vertebral-pelvic implantation|Implantation of two NEMOST rods (bilateral vertebral-pelvic implantation)
16085739|NCT02266667|Device|1 NEMOST rod :unilateral vertebral-pelvic implantation|Implantation of one NEMOST rod (unilateral vertebral-pelvic implantation)
16085740|NCT02266654|Other|IV fluids|Normal Saline 0.9%
16085741|NCT02266654|Other|Hospital Notification|Prehospital providers will notify the receiving hospital over the radio or telephone that they are transporting a patient who meets Sepsis Criteria
16085742|NCT02266641|Behavioral|nutrition counseling|Pregnancy diet (include one-carbon nutrients)
16085743|NCT02266641|Dietary Supplement|multivitamin supplement|
16085744|NCT02266628|Biological|RSV-F Vaccine|
16085745|NCT02266628|Biological|Saline Placebo|
16085746|NCT02266615|Genetic|Biobanking of biomaterial for future genetic research.|
16085747|NCT02266602|Radiation|Intraoperative Radiation Therapy|Intraoperative radiation therapy at the time of partial mastectomy in early stage breast cancer
16085748|NCT02266589|Drug|Hydrocortisone|Hydrocortisone hemisuccinate (Roussel-Uclaf, Romainville, France), 50 mg intravenously every 6 hrs
16085749|NCT02266576|Behavioral|Standard DPP|The Standard Diabetes Prevention Program (DPP) delivered by the San Jose State Timpany Center is the Group Lifestyle Balance™ DPP, which has previously been tailored for urban American Indians and Alaska Natives by the Indian Health Service. Standard DPP components consist of 16 group classes, 4 visits with a lifestyle coach and access to a therapeutic swimming pool and gym.
16085750|NCT02266576|Behavioral|Enhanced DPP|Enhanced DPP components consist of access to a mental health counselor, active referrals to mental health services, and traditional healing workshops such as the use of talking circles, a modified photo voice and digital storytelling to address specific psychosocial issues that are a result of historical trauma, stress, and grief.
16085751|NCT02266563|Drug|Amyvid PET Scan|A thin line will be inserted into a vein in one arm for the injection of the tracer. Subjects will begin the Amyvid PET scan 50-60 minutes after the injection of the tracer, and scanned for about 20 minutes.
16085752|NCT02266563|Drug|T807 PET scan|Scanning will begin 80 minutes after the injection of the tracer, and last for about 20 minutes.
16085753|NCT02266550|Drug|[14C] BILL 284 BS|
16085754|NCT02266537|Drug|Tamsulosin|
16085755|NCT02266537|Drug|Alfuzosin|
16085756|NCT02266537|Drug|Doxazosin|
16085757|NCT02266537|Drug|Placebo|
16085758|NCT02266524|Drug|Tamsulosin hydrochloride, very low dose|
16085759|NCT02266524|Drug|Tamsulosin hydrochloride, low dose|
16085760|NCT02266524|Drug|Tamsulosin hydrochloride, medium dose|
16085761|NCT02266524|Drug|Tamsulosin hydrochloride, high dose|
16085762|NCT02266511|Drug|Flomax®, Norman II facility|
16085763|NCT02266511|Drug|Flomax®, Nishine facility|
16085764|NCT02266498|Drug|BIBB 515 BS|
16085765|NCT02266498|Other|Standard breakfast (40 g fat)|
16085766|NCT02266485|Drug|BIBB 515 BS|
16085767|NCT02266485|Drug|Pravastatin|
16085768|NCT02266485|Drug|Placebo|
16085769|NCT02266472|Drug|metformin|single dose of metformin given as tablets
16085770|NCT02266472|Drug|empagliflozin/metformin|Single dose empagliflozin/metformin given as fixed-dose combination tablet
16085771|NCT02266472|Drug|empagliflozin|single dose of empagliflozin given as tablet
16085772|NCT02266459|Device|Microwave technology (Medfield Diagnostics)|A microwave measurement will be performed. The procedure will take approximately 15 minutes (the duration of the actual measurements is < 1 minute) and will not interfere with the patient's standard of care at the Stroke Unit.
16085773|NCT02266446|Behavioral|Attention & Interpretation Modification|
16085774|NCT02266433|Drug|Ketorolac|"The proposed use of ketorolac in this study is outside of the FDA-approved indication and is the investigational agent in this study
~Ketorolac is a non-steroidal anti-inflammatory drug (NSAID). The approved indication for Ketorolac is for the short-term (≤5 days) management of moderately severe, acute pain that requires analgesia at the opioid level, usually in a postoperative setting. It is highly protein bound (99%) and is largely metabolized by the liver. In it's approved indication it is contraindicated for those with renal impairment, active peptic ulcer disease, pregnant or nursing females, individuals with NSAID hypersensitivity, or individuals at high risk for bleeding/clotting disorders."
16085775|NCT02266433|Drug|Dexamethasone|"Dexamethasone is a synthetic corticosteroid and possesses glucocorticoid activity, and will be used within its labeled indication for this study: intra-articular or soft tissue injection for: synovitis of osteoarthritis, epicondylitis, acute nonspecific tenosynovitis. It is the active comparator in this study.
~In its approved indication there use limitations for immunocompromised individuals, pregnant females, persons with allergy to steroids, individuals with systemic fungal infections, and individuals with cerebral malaria. It is contra-indicated in systemic fungal infections, and hypersensitivity to any component of this product, including sulfites."
16085776|NCT02266420|Procedure|Blood samples of 10 mL|Blood samples of 10 mL will be collected at initial visit; serum samples will then be stored at the end of the study (-80°C) and may be used for the purpose of further scientific research.
16085777|NCT02266407|Procedure|Aquamantys System|The use of the saline-coupled bipolar sealing technology (Aquamantys® System, Medtronic Advanced Energy, LLC, Portsmouth, NH, USA) uses bipolar radiofrequency energy combined with a continuous-flow saline at the electrode tip to prevent tissue temperatures from exceeding 100 °C thus minimizing tissue charring. The temperature achieved is sufficient to induce a process called Transcollation(TM) which shrinks the collagen fibers in the walls of blood vessels, effectively sealing the blood vessels up to 1mm in diameter, resulting in the reduction of bleeding from soft tissue.
16085778|NCT02266394|Drug|Mesenchymal stem cell|Intra-arterial infusion of the single-dose MSC
16085779|NCT02266394|Procedure|Mesenchymal stem cell delivery with stent placement|Intra-arterial stent placement after Mesenchymal stem cell infusion
16085782|NCT02266381|Procedure|US combined with fluoroscopy-guided renal access|Patients undergo MPCNL using US combined with fluoroscopy-guided renal access
16085783|NCT02266368|Device|Antimicrobeal coated stents|Patients in the intervention arm will undergo placement of (Silver Sulphdiazine) antimicrobeal coated stents
16085784|NCT02266355|Drug|Omalizumab|Omalizumab 300 mg SQ every 2 weeks
16085785|NCT02266342|Device|GORE® TAG® Thoracic Endoprostheses|Endovascular therapy to treat thoracic disease
16085788|NCT02266316|Device|Air warming mask|Mask that warms air at the mouth
16085789|NCT02266303|Other|Insulin Start-up Checklist|The checklist is a simple A4 size, two sided, document. Eleven checklist items covering twenty-one key educational points are of the front. Images illustrating the process of using a syringe to draw up insulin from a vial as well as injection sites (for children, adults and pregnant women) are on the back.
16085790|NCT02266290|Procedure|taping of ankle sprain|All participants were taped for a lateral ankle sprain. The individual is in supine position keeping the foot and ankle in a neutral position. The strip (I) is applied with not stretch in the outside of the leg just above the ankle, and then the rest of the strip is applied on the outside of the ankle and under the heel.
16085791|NCT02266290|Device|Sport tex® kinesiotape|
16085792|NCT02266290|Device|Pretape Cramer®|
16085793|NCT02266277|Other|Arm 1: E-portal message with IVR call|Active electronic patient portal users will be randomized to receive an e-portal message and IVR calls. Both methods of outreach will provide patients with educational information about influenza vaccination, notify patients of local flu clinic schedules and elicit patient response to vaccination status and barriers.
16085794|NCT02266277|Other|Arm 2: E-portal message with no IVR call|Active electronic patient portal users will be randomized to receive only an e-portal message. The e-portal message will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers.
16085795|NCT02266277|Other|Arm 3: No e-portal message with IVR call|Active electronic patient portal users will be randomized to receive an IVR call. The IVR call will provide patients with educational information about influenza vaccination, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers.
16085796|NCT02266277|Other|Arm 5: IVR call|Non electronic patient portal users will be randomized to receive an IVR call with educational information about influenza vaccines, notification of local flu clinic schedules and elicit patient response to vaccination status and barriers.
16085797|NCT02266264|Drug|Hydrocortisone|Subjects will be divided into two groups by randomization. The intervention-group will be received 100 milligrams per day of hydrocortisone and the control-group will be received 200 milligrams per day of hydrocortisone in the first three days after enrollment.
16085798|NCT02266238|Device|DSA guided percutaneous balloon dilatation|Under the guidance of DSA, balloon is introduced into the stenosis area, proper pressure is given to achieve balloon dilatation to expand the narrow AVF lumen.
16085799|NCT02266238|Device|Ultrasound guided percutaneous balloon dilatation|Under the guidance of ultrasound, balloon is introduced into the stenosis area, proper pressure is given to achieve balloon dilatation to expand the narrow AVF lumen.
16085800|NCT02266238|Procedure|Surgical reconstruction|Direct surgery to reconstruction the AVF lumen.
16085801|NCT02266225|Other|Lifestyle-integrated Functional Exercise|Lifestyle-integrated functional exercise- one individual and four group-based sessions led by a physiotherapist over two months, and two phone calls one week and one month following final group-based exercise session.
16085802|NCT02266212|Procedure|5 ml arterial blood|A sample of 5 ml arterial blood will be withdraw to test the arterial blood oxygen saturation, CO2 content, carbon monoxide (CO) content and carboxyhemoglobin (COHg).
16085803|NCT02266186|Behavioral|Traditional Cognitive behavioural therapy|Therapist supported live therapy
16085804|NCT02266186|Behavioral|Internet based Cognitive behavioural therapy|Internetbased CBTwith limited therapist support
16085805|NCT02266173|Drug|Pertuzumab|Study protocol does not specify/enforce any particular dosage regimen. Pertuzumab will be administered according to standard of care and in line with current SmPC/local labelling.
16085806|NCT02266160|Drug|EMLA cream 5%|"the interventional group will spread 2 grams (2 ml) of EMLA cream over the post auricular area. after 4 hours the patient will wash away the cream. the treatment will last 4 days."
16085807|NCT02266160|Other|cetomacrogol cream (lotion cream)|lotion cream that does not contain active drug. has no contraindications
16085808|NCT02266147|Drug|SD-101|
16085809|NCT02266147|Radiation|Radiation therapy|
16085810|NCT02266134|Behavioral|Tailored Implementation of Measurement Based Care|measurement based care in this study is the practice of basing psychotherapeutic services on the results of the Patient Health Questionnaire, the implementation of measurement based care will be tailored based on clinic specific barriers and facilitators
16085811|NCT02266134|Behavioral|Standard Implementation of Measurement Based Care|measurement based care in this study is the practice of basing psychotherapeutic services on the results of the Patient Health Questionnaire (PHQ-9), the implementation of measurement based care will be standardized such that clinicians will be encouraged to administer the PHQ-9 to depressed clients before each session
16085812|NCT02266121|Device|tDCS|Device: transcranial direct current stimulation tDCS tdcs (ELDITH, Neuroconn, Ilmenau, Germany)
16085813|NCT02266108|Behavioral|ESTIMA Intervention|This study involves the evaluation of ESTIMA, a microfinance and gender equity intervention among women working as sex workers in Tijuana, Mexico.
16085814|NCT02266095|Device|Oval-8 Splint|Splinting with Oval-8
16085815|NCT02266095|Device|Tee Pee Splint|Splinting with Tee Pee
16085816|NCT02266095|Device|Forearm Based Splint|Splinting with Forearm based
16085817|NCT02266082|Other|No intervention|There is no intervention in this study.
16085901|NCT02265510|Drug|INCB052793|Initial cohort dose of INCB052793 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria.
16086297|NCT02262611|Drug|Micardis®|
16085818|NCT02266069|Other|Care Pathway for Primary Palliative Care|Early identification of palliative care patients, anticipatory care planning, systematic symptom assessment, interdisciplinary collaboration, rigorous follow-up of the functional status of the patient and giving attention to the informal care givers.
16085819|NCT02266056|Drug|Deep neuromuscular block using rocuronium and reversal with suggamadex|Deep neuromuscular block and moderate neuromuscular block with Esmerone and reversal with bridion
16085820|NCT02266056|Drug|Moderate neuromuscular block using rocuronium and reversal with suggamadex|Moderate neuromuscular block and moderate neuromuscular block with Esmerone and reversal with bridion
16085821|NCT02266043|Device|Pre-epiglottic baton plate (PEBP)|"modified acrylic palatal plate in which a velar extension resembling a spur or baton shifts the base of the tongue forward.
~This treatment is the standard care for infants with Pierre-Robin-Like Phenotype in the participating study centers and not assigned by protocol."
16085822|NCT02266030|Drug|Cilostazol|Pletaal as an active drug
16085823|NCT02266030|Drug|Aspirin|Aspirin as an active comparator
16085824|NCT02266017|Behavioral|Pain Coping Skills Training|
16085825|NCT02266004|Device|Transcranial Direct Current Stimulation (tDCS)|Anodal tDCS will be applied for the duration of the walking training at 2 milliamps with IOMED Phoresor.
16085826|NCT02266004|Other|locomotor training|An individualized dual-task walking program for approximately 30 minutes.
16085827|NCT02265991|Procedure|Fibula Explantation|surgical harvest of an osteomyocutaenous transplant consisting of a part of the fibula and surrounding soft tissues
16085828|NCT02265978|Device|CopeSmart|Participants will use the CopeSmart app at least once per day for four weeks
16085829|NCT02265965|Drug|intravenous nitroglycerin|Infusion at started at time of hysterotomy and stopped at neonate delivery
16085830|NCT02265952|Drug|REGN1500 250 mg SC/15 mg/kg IV/450 mg SC|Participants received single dose of REGN1500 subcutaneous (SC) injection of 250 milligrams (mg) at Week 0 (Day 1), followed by single dose of REGN1500 intravenous (IV) injection of 15 milligrams per kilogram (mg/kg) at Week 2 (Day 15) and then followed by 4 doses of REGN1500 SC injection of 450 mg once weekly starting from Week 12 (Day 85). Only the first 2 enrolled participants received 4 weekly REGN1500 450 mg SC doses at weeks 12, 13, 14, and 15 per the protocol. This dose regimen was removed under protocol amendment 4. Participants were followed for a period of 24 weeks (through Week 26 [Day 183]) after the last dose of study drug in the main study period.
16085831|NCT02265939|Drug|NPO-13|
16085832|NCT02265926|Device|N95 mask|N95 mask material used to cover aperture of Hans Rudolph mask
16085836|NCT02265900|Other|Exercise|One type of exercise
16085837|NCT02265900|Other|Exercise|A different type of exercise
16085838|NCT02265887|Other|standard of care|No intervention, this a patient registry and is purely an observational study
16085841|NCT02265861|Drug|HCG|
16085842|NCT02265848|Other|High frequency stimulation|Implanted pulse generator of a spinal cord stimulator will programmed to deliver high frequency stimulation for pain relief. For our purposes, high frequency stimulation will be defined as 1000 hertz.
16085843|NCT02265848|Other|Low frequency stimulation|Implanted pulse generator of a spinal cord stimulator will programmed to deliver low frequency stimulation for pain relief. Low frequency stimulation will be defined as conventional stimulation pulse generator programming.
16085844|NCT02265835|Other|no intervention|no intervention
16085845|NCT02265822|Drug|melatonin in children premedication|
16085846|NCT02265822|Drug|midazolam in children premedication|
16085847|NCT02265809|Drug|Aldesleukin|
16085848|NCT02265796|Drug|Ranolazine|"Ranolazine 500mg tablet
~500mg tablet two times per day for 7 days then,
~500mg tablet (1000mg) two times per day for 15 weeks"
16085849|NCT02265796|Drug|Sugar pill|"500mg tablet two times per day for 7 days then,
~500mg tablet (1000mg) two times per day for 15 weeks"
16085850|NCT02265783|Device|Nellcor USB Pulse Oximeter Monitor Interface Cable|Volunteers are subjected to certain simulated, sensor removal conditions known to represent challenges to the sensor-off feature. Such conditions include exposing the sensor to an ambient light source, sensor slipping off the finger with the light emitter and detector facing each other or a sensor slipping off under a blanket.
16085851|NCT02265770|Drug|16 weeks of VEC + CDDP|Days 1-36-71-106: Vincristine: 1.5 mg/m² (maximal dose 2 mg) i.v.; Days 1-3-36-38-71-73-106-108: Etoposide: 100 mg/m² infused over 60 minutes; Days 1-36-71-106: Cyclophosphamide: 3000 mg/m² in 3 divided infusions (1000 mg/m²/infusion) infused over 60 minutes; Days 22-57-92: Cisplatin: 80 mg/m² over 4 hours + Vincristine:1.5 mg/m² (maximal dose 2 mg) i.v.
16085852|NCT02265770|Drug|VEC + HD-MTX|Days 1-22-43: Vincristine: 1.5 mg/m² (maximal dose 2 mg) i.v.; Days 1-3-22-24-43-45: Etoposide: 100 mg/m² infused over 60 minutes; Days 1-22-43: Cyclophosphamide: 3000 mg/m² in 3 divided infusions (1000 mg/m²/infusion) infused over 60 minutes; Days 15-36-57: Administer methotrexate at 8000 mg/m² as a 24 hour IV infusion on days 15-36-57. 10% of the dose should be given over the first hour and 90% over the remaining 23 hours. The infusion must finish at 24 hours even if it has not been completed.
16085853|NCT02265770|Drug|Chemotherapy + Valproate|"Days 1-57-113-169-225-281-337: Vincristine and Carboplatin; Days 15-71-127-183-239-295-351: Vincristine and Methotrexate; Days 29-85-141-197-253-309-365: Vincristine and Cyclophosphamide; Days 43-44-99-100-154-155-211-212-267-268-323-324-379-380: Cisplatin 2-day continuous infusion.
~Valproate: initial dose 30 mg/kg/day for two weeks in 2 divided doses (BID 15 mg/kg). Increasing weekly up to 40 - 50 - 60 mg/kg/day in 2 divided doses."
16085854|NCT02265770|Radiation|Conformal radiotherapy|Conformal radiotherapy: 59.4Gy (children <18 months or with risk factors: 54Gy). Daily fraction 1.8 Gy, 5 fractions / week.
16085902|NCT02265510|Drug|gemcitabine|Gemcitabine administered intravenously over 30 minutes at the protocol-specified dose and frequency.
16085903|NCT02265510|Drug|nab-paclitaxel|nab-paclitaxel administered intravenously over 30 minutes at the protocol-specified dose and frequency.
16085904|NCT02265510|Drug|dexamethasone|Dexamethasone administered orally at the protocol-specified dose and frequency.
16085905|NCT02265510|Drug|Carfilzomib|Carfilzomib administered intravenously at the protocol-specified dose and frequency.
16085855|NCT02265770|Drug|VEC|D1: Vincristine: 1.5 mg/m² (maximal dose 2 mg) i.v.; D1-D3: Etoposide: 100 mg/m² infused over 60 minutes; D1: Cyclophosphamide: 3000 mg/m² in 3 divided infusions (1000 mg/m²/infusion) infused over 60 minutes; D22: Vincristine: 1.5 mg/m² (maximal dose 2 mg) i.v.; D22-D24: Etoposide: 100 mg/m² infused over 60 minutes; D22: Cyclophosphamide: 3000 mg/m² in 3 divided infusions (1000 mg/m²/infusion) infused over 60 minutes; D43: Vincristine: 1.5 mg/m² (maximal dose 2 mg) i.v.; D43-D45: Etoposide: 100 mg/m² infused over 60 minutes; D43: Cyclophosphamide: 3000 mg/m² in 3 divided infusions (1000 mg/m²/infusion) infused over 60 minutes
16085856|NCT02265770|Drug|Chemotherapy|Days 1-57-113-169-225-281-337: Vincristine and Carboplatin; Days 15-71-127-183-239-295-351: Vincristine and Methotrexate; Days 29-85-141-197-253-309-365: Vincristine and Cyclophosphamide; Days 43-44-99-100-154-155-211-212-267-268-323-324-379-380: Cisplatin 2-day continuous infusion.
16085857|NCT02265770|Radiation|conformal radiotherapy +/- boost|"Conformal radiotherapy: 59.4Gy (children <18 months or with risk factors: 54Gy). Daily fraction 1.8 Gy, 5 fractions / week.
~In case of persistent residue : Boost of radiation 8 Gy in 2 equivalent fractions"
16085858|NCT02265757|Behavioral|Cognitive Rehabilitation|"Will provide each couple with memory compensation training 5 days per week for 2 weeks, with initial and ending adherence sessions. All sessions will involve 45- 60 minutes of training. The curriculum is described briefly here.
~Learning phases. three training stages from learning theory: 1) an acquisition phase in which use of the memory compensation system is learned, 2) an application phase in which a participant is taught to apply to his/her daily life, and 3) an adaptation phase in which a participant practices incorporating into his/her daily life so as to make its use habitual."
16085859|NCT02265757|Behavioral|Computer Brain Fitness Training|Will use the commercially available Posit Science product BrainHQ™ (www.brainhq.com) on tablets (e.g. iPads). Participants will complete 45-60 minutes of training daily in the program and will be encouraged to maintain 250 minutes of computerized brain training per week for 18 months post program. Each participant's adherence and progress will be tracked through the clinician portal provided by Posit Science both during HABIT and for 18 months post-program.
16085860|NCT02265757|Behavioral|Support Group (patient and partner)|Patient: The patient support group will meet for 45-60 minutes daily. It will use the LifeBio Memory Journal© as a basis for reminiscence-focused group sessions. Partner: The care partner support group meets separately from the patient group for 45-60 minutes daily.
16085861|NCT02265757|Behavioral|Wellness Education|The education component will involve daily 60-minute group sessions with topics including Introduction to the Program, Living with MCI, Changes in Roles, Communication and Relationships, Sleep Hygiene, Steps to Healthy Brain Aging, Preventing Dementia, MCI and Depression, Nutrition and Exercise, Safety and Assistive Technologies, and Participating in Research, Community Resources, Meaning and Purpose, and Joy.
16085862|NCT02265757|Behavioral|Physical Exercise|The HABIT physical exercise intervention is intended to initiate and sustain a schedule rather than a type of physical activity. HABIT will provide a customized DVD as a supplement for continued use and practice after the program to those that opt to continue yoga. Will use an activity log completed by the partner to track activity level of the participants during the 18 month follow-up period.
16085863|NCT02265744|Drug|BMS-931699|
16085864|NCT02265744|Drug|Placebo matching BMS-931699|
16085865|NCT02265731|Drug|azacitadine|75 mg/m2 by IV infusion or subcutaneous dosing
16085866|NCT02265731|Drug|venetoclax|Step-up doses of venetoclax to the designated cohort dose
16085867|NCT02265731|Drug|rituximab / IDEC-C2B8|375 mg/m2 on Week 6
16085868|NCT02265731|Drug|rituximab / IDEC-C2B8|500 mg/m2 Week 10 Day 1 and thereafter
16085869|NCT02265718|Drug|Ritalin|1 - 20 mg tablet taken once on Day 0 and taken once on Day 28
16085870|NCT02265718|Drug|Placebo|1 - matching tablet taken once on Day 0 and once on Day 28
16085871|NCT02265718|Drug|Ritalin|1 - 20 mg tablet taken once on Day 0 and taken once on Day 28
16085872|NCT02265718|Drug|Placebo|1 - matching tablet taken once on Day 0 and once on Day 28
16085873|NCT02265705|Drug|Baricitinib|Administered orally
16085874|NCT02265705|Drug|Placebo|Administered orally
16085875|NCT02265679|Drug|BIIL 284 BS, low dose, pediatric patients|
16085876|NCT02265679|Drug|BIIL 284 BS, medium dose, pediatric patients|
16085877|NCT02265679|Drug|BIIL 284 BS, high dose, pediatric patients|
16085878|NCT02265679|Drug|BIIL 284 BS, low dose, adult patients|
16085879|NCT02265679|Drug|BIIL 284 BS, medium dose, adult patients|
16085880|NCT02265679|Drug|BIIL 284 BS, high dose, adult patients|
16085881|NCT02265679|Drug|Placebo|
16085882|NCT02265666|Drug|BIIL 284 BS Tablet FF|
16085883|NCT02265666|Drug|BIIL 284 BS tablet C|
16085884|NCT02265666|Other|standard breakfast|
16085885|NCT02265653|Drug|BIIL 284 BS tablet C|
16085886|NCT02265653|Drug|BIIL 284 BS tablet D|
16085887|NCT02265653|Drug|BIIL 284 BS WIF tablet|
16085888|NCT02265640|Drug|BIIL 284 BS boli|
16085889|NCT02265640|Drug|BIIL 284 BS tablet C|
16085890|NCT02265640|Other|standard breakfast|
16085891|NCT02265627|Drug|BIIL 284 BS|
16085892|NCT02265614|Genetic|PGS|
16085893|NCT02265601|Other|computer-based decision aid|Offers tailored education, values clarification exercises, and a sophisticated decision aid that translates an individual's goals and preferences into a specific medical plan that can be implemented by a health care team.
16085894|NCT02265601|Other|standard care|paper/pencil living will form
16085895|NCT02265588|Behavioral|Cognitive behavioral therapy|A disease specific cognitive behavioral therapy program called PASCET-PI: The PASCET-PI model focuses on behavioral activation, cognitive restructuring and problem solving skills to change maladaptive behaviors, cognitions and coping strategies specific for IBD.
16085896|NCT02265575|Drug|Hyaluronic Acid|rehydration using hyaluronidase-assisted subcutaneous infusion
16085897|NCT02265562|Drug|Misoprostol|60 minutes before the surgery 400 μg of misoprostol (2 tablets of 200 μg) inserted rectally
16085898|NCT02265562|Drug|Placebo|60 minutes before the surgery 2 tablet of placebo inserted rectally
16085899|NCT02265536|Drug|LY3022855|Administered IV
16085900|NCT02265523|Other|Cycle ergometer|The Viscus V1.5 is a kinetic flywheel cycle ergometer that will allow participants' pedal revolutions to be tracked as well as time of use.
16086298|NCT02262611|Drug|MicardisPlus®|
16085906|NCT02265510|Drug|bortezomib|Bortezomib administered intravenously or subcutaneously at the protocol-specified dose and frequency.
16085907|NCT02265510|Drug|lenalidomide|Lenalidomide administered orally at the protocol-specified dose and frequency.
16085908|NCT02265510|Drug|azacitidine|Azacitidine administered subcutaneously at the protocol-specified dose and frequency.
16085909|NCT02265510|Drug|INCB052793|INCB052793 tablets administered orally at the protocol specified dose strength and frequency.
16085910|NCT02265510|Drug|pomalidomide|Pomalidomide administered orally at the protocol-specified dose and frequency.
16085911|NCT02265510|Drug|INCB050465|INCB050465 tablets administered orally at the protocol specified dose strength and frequency.
16085912|NCT02265510|Drug|INCB039110|INCB039110 tablets administered orally at the protocol specified dose strength and frequency.
16085913|NCT02265484|Drug|Lactulose+Rifaximin +Bromocriptine|
16085914|NCT02265458|Behavioral|Musical intervention and sensory isolation|30 minutes musical intervention during NIV will be administrated, along with sensory isolation (mask obscuring the eyes)
16085915|NCT02265445|Drug|Deescalation therapy|Intravenous therapy Switch for a narrow spectrum beta-lactam active on the causative ESBL-PE.
16085916|NCT02265445|Drug|Maintaining carbapenem therapy|Intravenous therapy, Maintaining carbapenem therapy
16085917|NCT02265432|Behavioral|General physical activity educational materials|
16085918|NCT02265432|Device|Wearable activity tracking devices (fitbit)|
16085919|NCT02265432|Other|online map|
16085920|NCT02265432|Other|Personalized text messages|
16085921|NCT02265419|Device|Extracorporeal treatment with the Cytosorb adsorber|The extracorporeal treatment with the Cytosorb-Adsorber will be started 6 hours after heart surgery operation, the extracorporeal treatment duration will be 24 hours and the observation time 90 days.
16085922|NCT02265406|Drug|Anti-Infective Agents|
16085923|NCT02265406|Drug|Placebo|
16085924|NCT02265393|Drug|OTO-104|
16085925|NCT02265393|Drug|Placebo|
16085926|NCT02265380|Device|Placement of IV catheter|
16085927|NCT02265367|Drug|Levomilnacipran|
16085928|NCT02265367|Drug|Placebo|
16085929|NCT02265354|Behavioral|Collective-Intelligence computer tailored health communication|
16085930|NCT02265354|Behavioral|Rule-based computer tailored health communication|
16085931|NCT02265341|Other|Laboratory Biomarker Analysis|Correlative studies
16085932|NCT02265341|Drug|Ponatinib Hydrochloride|Given PO
16085933|NCT02265341|Other|Quality-of-Life Assessment|Ancillary studies
16085934|NCT02265328|Dietary Supplement|Bovine colostrum|Oral Bovine colostrum 200 ml (20 gram) TDS × 2 months
16085935|NCT02265328|Dietary Supplement|Enteral Nutrition|Enteral nutrition: Protein 1.5 gm/kg/day, energy (kcal) 40/kg/day, carbohydrate 67-80%, Fat 20-33%.
16085936|NCT02265328|Other|prednisolone|Oral prednisolone 40mg/day × 4 weeks and tapered to <40mg/day for next 4 weeks. (If Lilli score > 0.45 after 7 days, then prednisolone would be stopped)
16085937|NCT02265315|Other|Transcranial Magnetic Stimulation|Treament adjuvant applied to accelerate vocal motor learning and overall voice improvement
16085938|NCT02265315|Behavioral|Lee Silverman Voice Treatment|Time intensive behavioral treatment for Parkinson's hypophonia
16085939|NCT02265302|Drug|BIIL 284 oral solution|
16085940|NCT02265302|Drug|BIIL 284 wetability improved formulation (WIF) tablets|
16085941|NCT02265302|Drug|Placebo|
16085942|NCT02265289|Drug|Lefradafiban|
16085943|NCT02265289|Drug|Clopidogrel|
16085944|NCT02265276|Drug|Saroglitazar|Tab Saroglitazar 4 mg oral daily for 24 weeks
16085945|NCT02265276|Drug|Pioglitazone|Tab Pioglitazone 30 mg oral daily for 24 weeks
16085946|NCT02265250|Other|MRI|Noncontrast T1- and T2-weighted 3.0 T MRI of the bilateral carotid, coronary, and superficial femoral arteries
16085947|NCT02265250|Other|PET/MRI|Simultaneous 18F-NaF PET/MRI of the bilateral carotid, coronary, and superficial femoral arteries
16085948|NCT02265250|Other|Laboratory blood test|Cardiovascular biomarkers
16085949|NCT02265237|Drug|ombitasvir/paritaprevir/ritonavir|tablets
16085950|NCT02265237|Drug|ribavirin|tablets
16085951|NCT02265224|Drug|Acetylcysteine|
16085952|NCT02265211|Behavioral|Self-Help App|
16085953|NCT02265172|Procedure|Physiotherapy screening|Physiotherapy screening.
16085954|NCT02265172|Procedure|Standard practice|Orthopaedic surgeon assessment
16085955|NCT02265159|Procedure|Focal Therapy Using High Intensity Focused Ultrasound|
16085956|NCT02265120|Behavioral|Questionnaire|The Questionnaire aims to evaluate based on the responses if providers don't uniformly agree with the new guidelines, if they can't interpret them correctly, and or if they have personal biases towards the older guidelines based upon prior training, personal experience, financial incentives, etc.
16085957|NCT02265107|Other|exercise training|The program of exercise training (ET) was employed for 6 consecutive months with 3 sessions per week. The training of physical activity consisted of a combination of aerobic and resistance exercises for upper and lower limbs. Each session included: (1) 5-minute warm-up, (2) 30 minutes of aerobic exercise (performed in treadmills and stationary bikes); (3) 20 minutes of resistance exercises with dumbbells for upper limbs and ankle support for lower limbs (exercises preformed in diagonals) that consisted of 6 sets of 10 resistance exercises repeated for upper limbs, and the same number of sets for lower limbs; and (4) 5-minute cool-down, totaling ninety minutes of session per day (90min/day) and, two hundred and seventy minutes per week (270min/week).
16085958|NCT02265094|Other|Electroencephalography|EEG recordings during memory tests
16085959|NCT02265094|Behavioral|Neuropsychological assessment|patterns of eye gaze during cognitive tests
16085960|NCT02265081|Procedure|ultrasound|pelvic floor ultrasound
16085961|NCT02265081|Procedure|uroflow-meter|uroflow meter: measurement of passed urine volume
16085962|NCT02265068|Drug|Ticagrelor|Treatment of ACS patients with Ticagrelor
16085963|NCT02265055|Procedure|transfer early cleavage embryos|transfer early cleavage embryos
16085964|NCT02265055|Procedure|transfer non early cleavage embryo|
16085965|NCT02265042|Device|Stimulette|electrical stimulation device by Dr. Schuhfried Medizintechnik GmbH, Vienna, Austria
16086114|NCT02264015|Drug|Moxifloxacin, film-coated tablets|
16086115|NCT02264002|Drug|Cilobradine low dose 1|
16085966|NCT02265029|Other|Immediate spa treatment|spa treatment in rheumatology with sedative and antalgique techniques and mobilizing techniques (rehabilitation in pool)
16085967|NCT02265029|Other|Late spa treatment|spa treatment in rheumatology with sedative and antalgique techniques and mobilizing techniques (rehabilitation in pool)
16085968|NCT02264990|Drug|Paclitaxel|Administered by Intravenous infusion on Day 1 of each 21-day cycle
16085969|NCT02264990|Drug|Carboplatin|Administered by Intravenous infusion on Day 1 of each 21-day cycle
16085970|NCT02264990|Drug|Cisplatin|Administered by Intravenous infusion on Day 1 of each 21-day cycle
16085971|NCT02264990|Drug|Veliparib|Oral capsule, administered twice daily for 7 days in each 21-day cycle
16085972|NCT02264990|Drug|Pemetrexed|Administered by Intravenous infusion on Day 1 of each 21-day cycle
16085973|NCT02264977|Device|Branched TAG® Device|
16085974|NCT02264964|Device|GamCath®|Using non-cuff GamCath® catheter in patients with chronic renal failure requiring hemodialysis to building short-term vascular access in femoral vein.
16085975|NCT02264964|Procedure|Arteriovenous fistula creation|500 patients will undergo AVF creation in either arm for femoral vein catheterization group.
16085976|NCT02264964|Device|GamCath®|Using non-cuff GamCath® catheter in patients with chronic renal failure requiring hemodialysis to building short-term vascular access in right internal jugular vein.
16085977|NCT02264964|Procedure|Arteriovenous fistula creation|900 patients will undergo AVF creation in left arm for internal jugular vein catheterization group.
16085978|NCT02264951|Dietary Supplement|Tributyrin|a triglyceride containing three C4-acids
16085979|NCT02264951|Dietary Supplement|C8-diet oil|a triglyceride containing 2 C8-fatty acids and one oleic acid at sn-2 position
16085980|NCT02264951|Dietary Supplement|Olive oil|a triglyceride containing mostly three oleic acids
16085981|NCT02264951|Dietary Supplement|Carrot|mainly water and glucose
16085982|NCT02264938|Dietary Supplement|Antioxidant|Oral supplemmentation with antioxidants
16085983|NCT02264925|Device|Deep Brain Stimulation with Medtronic Activa PC+S systems|Deep Brain Stimulation of VIM.
16085984|NCT02264912|Drug|antiplatelet drugs - P2Y12 antagonists|
16085985|NCT02264899|Other|in Memento-VASCOD|"Pulse wave velocity assessment
~Cerebral MRI including Arterial Spin Labeling (ASL) and Magnetic Resonance Angiography (MRA) sequences
~Ophthalmological exams: Spectral Domain-Optical Coherence Tomography (SD-OCT), colour photographs of the retina, visual acuity and axial lenght measurement
~Neuropsychological testing and behaviorial and mood scales
~Urinary albumin excretion measurement"
16085986|NCT02264886|Radiation|MRI-guided stereotactive body radiation therapy|
16085987|NCT02264873|Drug|Decitabine|Dose escalation starting at 5 mg, and increasing by 2.5 mg to a Dose Level of 12.5 mg qd x 3 days.
16085988|NCT02264860|Dietary Supplement|Zinc and SAMe|The subjects will have the supplements dispensed at visit 2. They will be contacted weekly for the next three weeks to ensure that they are tolerating the supplements without significant side-effects. If these side-effects are significant then the dose of zinc will be decreased for all subjects to 15 mg of elemental zinc/day; if symptoms persist the SAMe dose will then be decreased by 25% (to 1200 mg/day) and then by 50% (to 800 mg/day) if necessary until the supplements are tolerated. 12 mg of zinc and 800 mg of SAMe is the lowest dose possible.
16085989|NCT02264847|Drug|Human chorionic gonadotrophin|Once a follicle reached more than 18 mm in size,women assigned to group (1) received 5,000 IU hCG trigger in the morning between 9 and 10 a.m. and the couple were advised to have intercourse the following night, about 36 hours later.
16085990|NCT02264847|Drug|clomiphene citrate alone|clomiphene citrate alone without hCG trigger
16085991|NCT02264834|Drug|Levobupivacaine 0.1% + Sufentanil 0.2µg/ml|Levobupivacaine 0.1% + Sufentanil 0.2µg/ml
16085992|NCT02264834|Drug|Levobupivacaine 0.07% + Sufentanil 0.3µg/ml|Levobupivacaine 0.07% + Sufentanil 0.3µg/ml
16085993|NCT02264834|Procedure|Lumbar epidural analgesia|Introduction of a catheter in lumbar epidural space
16085994|NCT02264821|Drug|ropivacaine infiltration|wound infiltration
16085995|NCT02264821|Drug|intrathecal morphine|100 µg added to the spinal anaesthesia
16085996|NCT02264821|Drug|placebo|placebo in spinal anaesthesia and in wound infiltration
16085997|NCT02264808|Other|Developmental Outcomes|A Bayley-III developmental assessment will be performed study subjects at age 18-20 months
16085998|NCT02264795|Drug|Lidocaine|Lidocaine 2% with epinephrine 5mcg/ml
16085999|NCT02264795|Drug|Placebo|0.9% Sodium Chloride Solution
16086000|NCT02264782|Other|Computer-Assisted Intervention|Complete PreView
16086001|NCT02264782|Other|Computer-Assisted Intervention|Watch an educational video
16086002|NCT02264782|Other|Questionnaire Administration|Ancillary studies
16086003|NCT02264769|Drug|Carbetocin|
16086004|NCT02264756|Other|ASP review|patients admitted to hospital with a diagnosis of community-acquired pneumonia will be reviewed by team members of antimicrobial stewardship program and subsequently feedback to attending physicians will be offered in the form of recommendations for antibiotic management
16086005|NCT02264743|Drug|Femoston Conti|Ultra-low-dose oral E2/D [Oestradiol 17β 0.5mg/dydrogesterone 2.5 mg] oral Femoston Conti 0.5mg Estradiol&Dydrogesterone vs Oestradiol&Norethisterone acetate
16086006|NCT02264743|Drug|EVOREL® CONTI|Trans-dermal Estradiol 25mcg/norethisterone acetate 85 mcg 1/2 an Evorel Conti patch
16086007|NCT02264730|Drug|ClotFoam|Patient has not received blood products between screenings
16086008|NCT02264717|Procedure|SPECT|Patients are randomized to either SPECT or Cardiac MRI
16086009|NCT02264717|Procedure|Cardiac MRI|Patients are randomized to either SPECT or Cardiac MR
16086010|NCT02264704|Other|High intensity exericse|Participants will exercise at high intensity (70% VO2 peak) intermittently (30 seconds on, 30 seconds off) for 15 minutes, twice weekly for 15 weeks. Workload may increase as the study progresses based on heart rate response.
16086011|NCT02264704|Other|Moderate intensity exericse|Participants exercise at moderate intensity (35% VO2 peak) continuously for 15 minutes, twice weekly for 15 weeks. Workload may increase as the study progresses based on heart rate response.
16086116|NCT02264002|Drug|Cilobradine low dose 2|
16086117|NCT02264002|Drug|Cilobradine medium dose|
16086118|NCT02264002|Drug|Cilobradine high dose 1|
16086119|NCT02264002|Drug|Cilobradine high dose 2|
16086120|NCT02264002|Drug|Metoprolol succinate tablets|
16086016|NCT02264665|Drug|sunitinib|sunitinib 37.5mg/d orally
16086017|NCT02264665|Drug|everolimus|everolimus 10mg/d orally
16086018|NCT02264665|Drug|chemotherapies recommended in france|depends on the chemotherapy prescribed (IV)
16086019|NCT02264652|Device|HD Transcranial Direct Stimulation|Genuine cathodal HD-tDCS will be delivered through High Definition electrodes that will be arranged on the skull according to a 4x1 ring configuration.
16086020|NCT02264639|Drug|Pegcetacoplan|Complement (C3) Inhibitor
16086021|NCT02264626|Drug|Remifentanil|infusion at a rate by 0.025 μg kg-1 min-1 every minute to a maximum of 0.15 μg kg-1 min-1.
16086022|NCT02264613|Drug|ALRN-6924|ALRN-6924 will be administered as an IV infusion
16086023|NCT02264587|Drug|Mosapride|Mosapride 5mg by mouth ,3 times one day for 1 4days.
16086024|NCT02264587|Drug|domperidone|Domperidone 10mg by mouth ,3 times one day for 1 4days.
16086025|NCT02264574|Drug|Ibrutinib|Ibrutinib will be supplied as 140 mg hard gelatin capsules for oral (PO) administration.
16086026|NCT02264574|Drug|Obinutuzumab|Obinutuzumab will be supplied as 1000 mg/40 mL solution in a single-use vial for intravenous (IV) administration
16086027|NCT02264574|Drug|Chlorambucil|Chlorambucil will be supplied as 2 mg film-coated tablets for oral (PO) administration
16086028|NCT02264561|Other|Food|Active group
16086029|NCT02264561|Other|Food|Control group
16086030|NCT02264548|Radiation|Radio-Ablation|Level I 20Gy/5 Level II 25Gy/5 Level III 30Gy/5 Level IV 35Gy/5 Level V 40Gy/5
16086031|NCT02264535|Drug|0.1mg/ml Ginkgolides Meglumine Injection|
16086032|NCT02264535|Drug|1mg/ml Ginkgolides Meglumine Injection|
16086033|NCT02264535|Drug|5mg/ml Ginkgolides Meglumine Injection|
16086034|NCT02264522|Other|Place dialysis chair into position 3.|Upon device notification event 1, place patient in dialysis chair position 3.
16086035|NCT02264522|Other|Decrease dialysate temperature.|Upon device notification event 2, decrease dialysate temperature by 0.5 degree centigrade.
16086036|NCT02264522|Other|Decrease ultrafiltration rate by 25%.|Upon device notification event 3, decrease ultrafiltration rate by 25% from baseline ultrafiltration rate.
16086037|NCT02264522|Other|Decrease ultrafiltration rate by 50%.|Upon device notification event 4, decrease ultrafiltration rate by 50% from baseline ultrafiltration rate.
16086038|NCT02264509|Procedure|Ankle-Brachial index|The only procedure to be performed is the measurement of ABI for the diagnosis of arterial insufficiency.
16086039|NCT02264496|Behavioral|Exercise|
16086040|NCT02264470|Other|Not relevant|Not relevant
16086041|NCT02264457|Device|T-flex Aspheric Toric IOL|
16086042|NCT02264457|Device|AT TORBI toric IOL|
16086043|NCT02264444|Other|Cholecystectomy visualization|Patients undergo a standard removal of the gallbladder through a single incision at the umbilicus will have their operation recorded and graded according to a scale that is established for this study.
16086044|NCT02264418|Drug|ODM 203|ODM 203
16086045|NCT02264418|Drug|ODM 203|ODM 203
16086046|NCT02264392|Procedure|Ultrasound Guided Incision and Drainage|Ultrasound guidance of the abscess drainage
16086047|NCT02264392|Procedure|Blind Incision and Drainage|Incision and drainage of abscess guided by physical exam alone
16086048|NCT02264379|Radiation|normal fractionated irradiation|25*2 Gy (once a day, 5 days a week)
16086049|NCT02264379|Radiation|hypo fractionated irradiation|3*10 Gy (once a day, 2-3 days a week)
16086050|NCT02264366|Behavioral|Motivational Communication for Health Behavior management|"An appropriate and evidence-informed model of motivational counselling, health coaching and chronic disease self-management will be integrated into the delivery of all aspects of the ACCELERATION program. The focus will be on 4 health behaviors that include healthy eating, exercise, smoking cessation and moderation of alcohol consumption. This will include engagement techniques such as motivational interviewing, identification of stage of change, visioning of best self, goal setting and action planning, expressing empathy, developing discrepancy, decisional balance, rolling with resistance, and supporting self-efficacy. (Rubak 2005, Knight 2006)."
16086051|NCT02264353|Drug|Donepezil|Donepezil 10mg before sleep
16086052|NCT02264353|Drug|placebo|One piece of placebo before sleep
16086053|NCT02264340|Behavioral|Relaxation technique Autogenic Training|Autogenic Training
16086054|NCT02264340|Behavioral|Combined treatment Autogenic Training + Cervical exercises and postural correction|Autogenic Training + Cervical exercises and postural correction
16086121|NCT02264002|Drug|Placebo|
16086122|NCT02263989|Drug|Telmisartan film coated tablet|
16086123|NCT02263989|Drug|Telmisartan conventional tablet|
16086124|NCT02263976|Drug|BEA 2180 BR|
16086125|NCT02263976|Drug|Placebo|
16086126|NCT02263976|Device|Respimat® A 4|
16086127|NCT02263976|Drug|Methacholine Chloride|methacholine challenge test
16086055|NCT02264327|Behavioral|Motivational Interviewing Simulator (SIM)|The interactive, case-based, multiplayer web-based game allows service providers to deepen their skills in Motivational Interviewing (MI), a widely recognized evidence-based practice that supports people to make positive behavior changes related to health, wellness, mental illness, and addiction.The SIM will have three arenas for play, so that users can practice more advanced MI skills and include: Single Player, Two Player, and Advanced Free play. The SIM is equipped with multiple story-lines and characters to keep learners engaged over time and to provide practice on diverse case scenarios, making the Sim relevant to a wide audience. Lastly the SIM will provide an opportunity for feedback from peers and MI experts.
16086056|NCT02264327|Behavioral|Motivational Interviewing eBook (eBook)|"The Phase I research team developed a 69-page eBook as a credible online comparator that presents information comparable to that included in the Sim, but without the interactive, role-playing, peer learning functionalities embodied in the Sim. Developed in Hyperlink Markup Language, the eBook presented MI skills, followed by transcripts of effective and not-effective samples of MI from the Sim itself. The e-Book includes the story-lines along with sample dialogue and expert feedback on MI skills."
16086057|NCT02264327|Behavioral|Motivational Interviewing Training (MI Training)|The training intervention consists of a free two-day standardized Motivational Interviewing (MI) training provided by experienced MI trainers.
16086058|NCT02264314|Behavioral|Active Communication Education Program|A behavioral intervention aimed to improve the adherence to the hearing aid in older adults with hearing loss
16086059|NCT02264314|Other|Control|Participants in this arm will not receive intervention during the study protocol time. After the completion of the protocol, they will receive the same intervention that the intervention group, meaning the ACE program intervention.
16086060|NCT02264301|Drug|Puerarin injection 400 mg|
16086061|NCT02264301|Drug|Qingkailing injection 40 ml|
16086062|NCT02264288|Biological|3 x 10^6 cells|3 x 10^6 cells administered on Study Days 1 and 8
16086063|NCT02264288|Biological|10 x 10^6 cells|10 x 10^6 Human Placenta Derived cells (PDA-002) administered on Study Days 1 and 8
16086064|NCT02264288|Biological|30 x 10^6 cells|30 x 10^6 Human Placenta Derived cells (PDA-002) administered intramuscularly on Study Days 1 and 8
16086065|NCT02264288|Other|Placebo|Identical matching placebo administered IM on Study Days 1 and 8
16086066|NCT02264275|Behavioral|Aerobic Exercise Training|The aerobic exercise training uses a television attached to a Nintendo Wii videogame console with a dance game to be played by participants on 5 days per week using a ramped-duration schedule (from 10-30 minutes of moderate physical activity daily).
16086067|NCT02264262|Other|Physiologic maneuvers|Subjects will perform cold pressor test, valsalva maneuver, hand grip and post-exercise occlusion in a controlled research environment
16086068|NCT02264249|Other|Esophagogastroduodenoscopy and colonoscopy split dose prep|"Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy receive the Split dose colonoscopy prep
~split dose colonoscopy preparation- ½ evening before and ½ early AM (4L volume or 2L volume bowel preparation)"
16086069|NCT02264249|Other|Esophagogastroduodenoscopy and colonoscopy Evening before colonoscopy prep|Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy receive Evening before (4L, 2L or miralax bowel preparation)
16086070|NCT02264249|Other|Esophagogastroduodenoscopy and colonoscopy Same day prep colonoscopy preparation|Patients undergoing a combined EGD (esophagogastroduodenoscopy) and a colonoscopy receive Same day prep (4L volume or 2L volume or Miralax bowel preparation)
16086071|NCT02264236|Biological|P10s-PADRE vaccine|"P10s-PADRE vaccine combined with MONTANIDE™ ISA 51 VG Chemotherapy Subcutaneous injection at weeks 2, 3, 5, and 6. 3-Week Interval Immunotherapy Subcutaneous injection at weeks 2, 3, and 4. 2-Week Interval Immunotherapy Subcutaneous injection at weeks 3, 4, and 5."
16086072|NCT02264223|Dietary Supplement|Fermented red clover isoflavones in aglycone form|Fermented isoflavones in aglycone form
16086073|NCT02264223|Dietary Supplement|Unfermented glycosides (as aglycone equivalents)|Unfermented aglycone equivalents in glycoside form
16086074|NCT02264210|Drug|Icotinib|Icotinib 125 mg three times daily (375 mg per day) by mouth for 12 months.
16086075|NCT02264197|Drug|BIBX 245 CL - fed|
16086076|NCT02264197|Drug|BIBX 245 CL- fasted|
16086077|NCT02264184|Drug|Tamsulosin|
16086078|NCT02264184|Drug|Paroxetine|
16086079|NCT02264171|Drug|Tamsulosin HCl|
16086080|NCT02264171|Drug|Ketoconazole|
16086081|NCT02264158|Drug|Telmisartan high|
16086082|NCT02264158|Drug|Telmisartan low|
16086083|NCT02264158|Drug|Lacidipine high|
16086084|NCT02264158|Drug|Lacidipine low|
16086085|NCT02264158|Drug|Placebo|
16086086|NCT02264145|Drug|Ethanolic Solution From HFA134a-MDI - low|
16086087|NCT02264145|Drug|Ethanolic Solution From HFA134a-MDI - medium|
16086088|NCT02264145|Drug|Ethanolic Solution From HFA134a-MDI - high|
16086089|NCT02264145|Drug|Ethanolic Solution From Respimat®|
16086090|NCT02264132|Drug|Pramipexole ER tablet|
16086091|NCT02264132|Drug|Pramipexole IR tablet|
16086092|NCT02264119|Drug|Lefradafiban tablet|
16086093|NCT02264119|Drug|Pantoprazole tablet|
16086094|NCT02264119|Device|Lefradafiban double chamber sachet|
16086095|NCT02264106|Drug|Lefradafiban tablet|
16086096|NCT02264106|Drug|Lefradafiban double chamber sachet|
16086097|NCT02264106|Drug|Pantoprazole|
16086098|NCT02264093|Drug|Propranolol|
16086099|NCT02264093|Drug|Talsaclidine|
16086100|NCT02264080|Drug|WAL2014|
16086101|NCT02264080|Drug|Placebo|
16086102|NCT02264067|Drug|Talsaclidine|
16086103|NCT02264067|Drug|Placebo|
16086104|NCT02264054|Drug|[14C]talsaclidine, oral|
16086105|NCT02264054|Drug|[14C]talsaclidine, iv|
16086106|NCT02264041|Drug|Cilobradine, low dose|
16086107|NCT02264041|Drug|Cilobradine, high dose|
16086108|NCT02264041|Drug|Itraconazole|
16086109|NCT02264028|Drug|[14C]-DK-AH 269 CL, solution for infusion|
16086110|NCT02264028|Drug|[14C]-DK-AH 269 CL, drinking solution|
16086111|NCT02264015|Drug|Cilobradine, low, film-coated tablets|
16086112|NCT02264015|Drug|Cilobradine, high, film-coated tablets|
16086113|NCT02264015|Drug|Placebo, film-coated tablets|
16086129|NCT02263963|Drug|Exparel|In this arm as described above the intervention will be TAP block injection under ultrasound guidance using Exparel.
16086130|NCT02263963|Procedure|TAP Block|no intervention will be done to this arm.
16086131|NCT02263950|Drug|Artemether|Artemether sublingual spray at 20mg per spray. Dose escalation study design as per protocol; in Phase 1, three dose levels will be given. The Phase 2 dose will be determined from the results of Phase 1. All patients will receive 4 cycles of dosing, 28 days per cycle.
16086132|NCT02263937|Procedure|Bilateral Nucleus Basalis Meynert DBS|Low frequency stimulation applied using standard Deep brain stimualtion hardware.
16086133|NCT02263937|Procedure|Sham Nucleus Basalis Meynert DBS|DBS system switched off.
16086134|NCT02263924|Dietary Supplement|Tocotrienol|Subjects in the intervention arm will take one capsule of 200mg tocotrienol twice daily for 6 months
16086135|NCT02263924|Dietary Supplement|Placebo capsules|Subjects in the placebo arm will take one capsule of placebo twice daily for 6 months
16086136|NCT02263911|Drug|Baricitinib|Administered orally
16086137|NCT02263898|Drug|Raf kinase inhibitor LGX818|Given PO
16086138|NCT02263898|Drug|binimetinib|Given PO
16086139|NCT02263898|Other|laboratory biomarker analysis|Correlative studies
16086140|NCT02263885|Device|ExAblate Transcranial System|Transcranial MRgFUS
16086141|NCT02263872|Drug|Minocycline|Minocycline 200mg perday
16086142|NCT02263859|Device|aura6000 System|The aura6000 System is intended to unilaterally stimulate the hypoglossal nerve which innervates the muscles of the tongue. The aura6000 System stimulates the hypoglossal nerve cyclically and continuously during sleep to maintain muscle tone of the tongue and upper airway during sleep. Stimulation is generated by a programmable, multi-current source, implantable neurostimulator (IPG) and delivered to the hypoglossal nerve by a lead with multi-contact cuff electrode (lead).
16086143|NCT02263833|Drug|Mircera|Participants received Mircera according to individualized physician-prescribed regimen.
16086144|NCT02263807|Procedure|MPFL Group|MPFL reconstruction or standard treatment followed by physiotherapy
16086145|NCT02263807|Procedure|Control|Arthroscopy followed by active rehabilitation
16086146|NCT02263794|Procedure|Conventional Bronchial Thermoplasty|Conventional bronchial thermoplasty is performed during three bronchoscopy sessions each separated by approximately three weeks.
16086147|NCT02263794|Procedure|Image Guided Bronchial Thermoplasty|Patient-specific bronchial thermoplasty based on imaging data will be performed during one bronchoscopy session.
16086148|NCT02263781|Procedure|Blood draw|Blood draw
16086149|NCT02263781|Procedure|muscle biopsy|Muscle biopsy during planned anesthesia/surgery
16086150|NCT02263768|Procedure|Oral clinical conditions|Caries incidence assessment dental anxiety assessment oral health related quality of life assessment time and costs assessment
16086151|NCT02263742|Behavioral|Peer whole health intervention|Provide wraparound peer support, education, and navigation to individuals
16086152|NCT02263742|Behavioral|EBPs at Wellness Center|four EBPs: a) on-site primary care; b) screening of clients for modifiable risk factors and medical conditions; c) care coordination; and d) peer health navigation
16086153|NCT02263729|Drug|Losartan|
16086154|NCT02263729|Drug|placebo|
16086155|NCT02263703|Biological|Quadrivalent HPV vaccine|Three 0.5 mL doses will be given at time 0, 2 months after the 1st dose and then 6 months after the initial dose. For kidney transplant recipients the first dose will be at least 6 months post-transplant.
16086156|NCT02263690|Procedure|Group Drops|The patients in the group Drops received a drop of proparacaine 0.5% before receiving a peri-ocular drop of povidone iodide 5%. The patients in the group Drops received a second drop of proparacaine 0.5% 5 minutes after the drop of povidone iodide 5%
16086157|NCT02263690|Procedure|Group SC|The patients in the group SC received a drop of proparacaine 0.5% before receiving a peri-ocular drop of povidone iodide 5%. In the patients in the group SC, a subconjunctival bleb of anesthesia was created by injecting 0,4 mL of lidocaine 1% into the subconjunctival space 4 mm posterior to the superotemporal limbus with a 30-gauge, 1/2-inch needle attached to a 1-mL syringe.
16086158|NCT02263690|Procedure|Group gel|For the patients in group gel, the gel was placed on the eye before receiving the peri-ocular drop of povidone iodide 5%.
16086159|NCT02263677|Drug|Sitagliptin|60 day supply of 100mg Sitagliptin. The investigators will use an MRS (a non invasive method using magnets) to evaluate liver fat before and after subjects take a diabetes medication. The investigators will also collect a small amount of blood to measure liver, kidney and hormone functions. This will be done 4 times. Also, at the time of the subject gets their first dose of medication they will have a DEXA (low exposure x-ray often used in clinical practice to measure bone density and body composition).
16086160|NCT02263651|Procedure|Quilting suture without drainage|"In an attempt to obliterate the dead space, the skin flaps are sutured to the underlying pectoralis major with multiple parallel rows of 0/0 vicryl (or equivalent). Running sutures at periodic intervals (<2cm) are placed from the skin flaps to the underlying muscle. Minor dimpling is considered acceptable and is expected to resolve. If severe dimpling is observed, stitches are removed and replaced.
~Efficiency of quilting suture relies on a rigorous repartition of the sutures with a special attention taken to the obliteration of the largest potential dead spaces and the empty axillary apex.
~The skin edges are sutured as stated before for the control group. Closed suction will not be used for draining the pectoral area."
16086161|NCT02263651|Procedure|Conventional closure with drainage|"The skin flaps are not fixed subcutaneously but sutured at the edges, a closed suction drain is inserted under the flaps in the dead space created by the dissection at the pectoral area. The drain is stitched to the skin.
~The skin is closed in two layers with absorbable sutures, a deep layer of 2.0 or 3.0 vicryl sutures or equivalent, and a subcuticular closure with absorbable 3.0 or 4.0 Monocryl sutures or equivalent."
16086162|NCT02263638|Drug|Anakinra|One daily subcutaneous injection of a fixed dose of 100 mg will be administered at a fixed time during a five day period
16086163|NCT02263586|Behavioral|Education in nutrition|Athletes were given a 45 min lesson on the proper diet and fluid intake to prevent hyponatremia in long-distance triathlon.
16086234|NCT02263079|Drug|Entecavir|Participants will receive entecavir, either as a film-coated tablet or oral solution, once daily at a dose of 0.015 milligrams per kilogram (mg/kg) (maximum daily dose of 0.5 mg).
16086288|NCT02262676|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Patients treated by Physicians under approved local prescriptions
16086164|NCT02263573|Other|PEP'C-R|"Preliminary session of calibration and tolerance: Test of Borg: determination of VT1 for 10 minutes, 3 min pedaling at 25 W and then 20 minutes pedaling on VT1 determined during the exercise test (ET) -10%.
~Session 1: 30 min of pedaling at constant load VT1 determined during exercise testing (EE) - 10%.
~Session 2 Session 17: increase in the burden of BASE (5 BASE * 5 min: 25 min) by 10% and decrease in relation to the load of the PIC (5 PIC * 1 min: 5 min) to get a cumulative charge of the same session. Changes in heart rate (HR) determine the evolution of sustained loads: a decrease of 10 bpm in heart rate leads to an increase by 10% in the intensity of the base (PIC load remains constant).
~Session 18 = Session 1."
16086165|NCT02263573|Other|Control group usual activities|Participants in the control group will not follow the intervention PEP'C-R. They will continue their usual activities for 9.5 weeks and will be assessed before and after this period. After the study, they will be offered the benefit of the conventional program of the PEP'C.
16086166|NCT02263560|Behavioral|Kinematic measurements|
16086167|NCT02263547|Drug|teriflunomide|
16086168|NCT02263547|Drug|Colestipol|
16086169|NCT02263534|Procedure|single incision minisling|midline incision of the vagina at midurethral level dissection of the vagina from perivesical fascia insertion of the tape (polypropylene macropore mesh tape) in the retropubic direction with its end grasped with an artery forceps till level of perineal membrane closure of the vagina 2 sham incisions if the skin only will be made at suprapubic to maintain blindness posterior colpoperneorraphy will be carried out if needed
16086170|NCT02263534|Procedure|tension free vaginal tape|midline incision of the vagina at midurethral level dissection of the vagina from perivesical fascia insertion of the tape (polypropylene macropore mesh tape) with the applicators in the retropubic direction and 2 skin incision will be made supra pubic through which the applicators will be passed and removed and the tape will be cut at level just below the skin closure of the vagina posterior colpoperneorraphy will be carried out if needed
16086171|NCT02263521|Other|No intervention employed. Study is based on a cross-sectional observational design.|
16086172|NCT02263508|Drug|talimogene laherparepvec|Phase 1b: talimogene laherparepvec will be administered by intralesional injection at Day 1, Week -5; then every 2 weeks starting at Day 1, Week -2; Phase 3, Arm 1 talimogene laherparepvec will be administered by intralesional injection at Day 1 Week 0, 3, 5, 7 then every 3 weeks starting at Day 1 Week 9.
16086173|NCT02263508|Drug|pembrolizumab (MK-3475)|Phase 1b: pembrolizumab will be administered intravenously every 2 weeks starting at Day 1 Week 0; Phase 3, Arm 1 and Arm 2 pembrolizumab will be administered intravenously on Day 1 Week 0, then every 3 weeks starting at Day 1 Week 3.
16086174|NCT02263508|Drug|placebo|Phase 3, Arm 2 placebo will be administered by intralesional injection at Day 1 Week 0, 3, 5, 7 then every 3 weeks starting at Day 1 Week 9.
16086175|NCT02263495|Drug|Paclitaxel|175mg/m2 + D5W 500mL MIV over 3hrs before gemcitabine administration
16086176|NCT02263495|Drug|Eribulin|1.0 mg/m2, 2-5min iv before gemcitabine (or miv with NS 100ml in max.)
16086177|NCT02263495|Drug|Gemcitabine|PG:1250mg/m2 + NS 100ml MIV over 30mins EG:1000mg/m2 + NS 100ml MIV over 30mins
16086178|NCT02263482|Other|control|No intervention during the 8-weeks period of the study because of awaiting evaluation for cardiac rehabilitation or transplantation
16086179|NCT02263482|Other|moderate-intensity group|Patients will be submitted to a 8-weeks training program with inspiratory muscle trained at 30% of the maximal inspiratory pressure (30 minutes/session/7 days/week) + peripheral muscle trained with exercises of upper limbs and lower limbs (50% 1 RM, increased every 2-weeks).
16086180|NCT02263482|Other|low-intensity group|Patients will be submited to a 8 weeks training program, with inspiratory muscle trained at 15% of the maximal inspiratory pressure (30 minutes/session/7 days/week) + peripheral muscle trained with exercises of upper limbs and lower limbs (0,5 kg each)
16086181|NCT02263469|Biological|Replenine®-VF (High Purity Factor IX)|
16086182|NCT02263456|Biological|Replenine®-VF (High Purity Factor IX)|
16086183|NCT02263443|Procedure|Soap suds enema (S.S.E.)|Patients in S.S.E. group will bowel preparation by soap suds enema until clear at night before surgery.
16086184|NCT02263443|Procedure|sodium chloride enema|Patients in unison enema group will Unison enema 100 ml per rectal at night before surgery
16086185|NCT02263443|Procedure|No enema|Patients NPO groups will NPO and no bowel preparation.
16086186|NCT02263430|Device|Deep Brain Stimulation|
16086187|NCT02263417|Device|Deep Brain Stimulation (DBS) of Gpi|
16086188|NCT02263417|Device|Deep Brain Stimulation (DBS) of STN|
16086189|NCT02263404|Device|Deep Brain Stimulation|DBS Implant Stimulation
16086190|NCT02263391|Behavioral|Opt-in or Opt-out testing|Study participants will be offered a health screening onsite.
16086191|NCT02263391|Behavioral|Focus Group|Study participants will be invited to participate in a focus group discussion.
16086192|NCT02263378|Drug|ellagic acid + annona muricata|pills
16086193|NCT02263365|Drug|Loperamide|Loperamide 12mg per day (4mg t.i.d) for 2 weeks post discharge
16086194|NCT02263352|Drug|Lycored soft gels Jagsonpal Pharma, Systemic 8mgms/day|Lycopene 8mgms taken orally ,one per day for two months.
16086195|NCT02263352|Device|Scaling and root planing|Scaling and root planing, otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or deep cleaning, is the process of removing or eliminating the etiologic agents - dental plaque, its products, and calculus
16086196|NCT02263339|Behavioral|Aerobic Exercise|Each subject will exercise 30 minutes per session, four times per week for 8 weeks at the OHSU Human Performance Laboratory (HPL). Choice of treadmill or cycle ergometer for each subject will be made based on subject ability by the HPL staff and maintained for the duration of the study. Exercise intensity will be determined by training heart rate to be provided to the subject based on the anaerobic threshold during initial stress test. Throughout the study, patients will be instructed not to alter their diet or baseline level of activity.
16086197|NCT02263339|Behavioral|Stretching|Each subject will follow a self-guided stretching program 30 minutes per session, four times per week for 8 weeks. The initial session will be supervised at the OHSU Human Performance Laboratory (HPL) and additional supervised sessions will occur every 2 weeks to support compliance with the program. Throughout the study patients will be instructed not to alter their diet or baseline level of activity.
16086235|NCT02263079|Drug|Lamivudine|Participants will receive lamivudine, either as a film-coated tablet or oral solution, once daily at a dose of 3 mg/kg (maximum daily dose of 100 mg).
16086198|NCT02263339|Behavioral|Aerobic Exercise- Healthy Subjects|Each subject will follow a self-guided aerobic exercise program 30 minutes per session, four times per week for 8 weeks. The initial session will be supervised at the OHSU Human Performance Laboratory (HPL) and additional supervised sessions will occur every 2 weeks to support compliance with the program. Throughout the study patients will be instructed not to alter their diet or baseline level of activity.
16086199|NCT02263326|Drug|dolutegravir|50 mg tablet by mouth once daily for 48 weeks
16086200|NCT02263326|Drug|lamivudine|300 mg tablet by mouth once daily for 48 weeks
16086201|NCT02263326|Drug|Continue current antiretroviral regimen|Continue current DHHS recommended or alternative three-drug antiretroviral regimen
16086202|NCT02263313|Other|EGO-COMBO group|Assess the safety and effectiveness of Combo stent
16086203|NCT02263287|Other|LeSCoD scale|LeSCoD is a clinical scale
16086204|NCT02263274|Device|Transcranial Direct Current Stimulation (TDCS)|Conventional tDCS and low-frequency tACS are commonly administered at a current intensity of 2 mA or less
16086205|NCT02263261|Other|Flex HD Pliable Perforated HADM|Human Acellular Dermal Matrix
16086206|NCT02263248|Drug|venlafaxine|slow titration to a maximum of 300 mg per day. will remain on venlafaxine XR for upto 32 weeks.
16086207|NCT02263248|Drug|buprenorphine|randomized to either buprenorphine or placebo, dose range from 0.2 mg qd/ to 1.2 mg qd
16086208|NCT02263248|Drug|placebo|patients will remain on venlafaxine XR and be randomzied to receive either placebo or buprenorphine for 8 weeks. at the end of 8 weeks those who did not receive buprenorphine will be given an opportunity to try it.
16086209|NCT02263235|Biological|administration of stable isotope-labelled leucine-|- administration of stable isotope-labelled leucine : by drip, for group 2A and group 2B. Group 1 (control group) : 1 collection of CSF. Group 2B : 4 collections of CSF, 24 hours after administration of stable isotope-labelled leucin. Group 2A (patients with brain trauma, acute hydrocephaly) : continuous collection of CSF, for 24 to 36 hours
16086210|NCT02263235|Other|collection of CSF, blood, urine, saliva|- administration of stable isotope-labelled leucine : by drip, for group 2A and group 2B. Group 1 (control group) : 1 collection of CSF. Group 2B : 4 collections of CSF, 24 hours after administration of stable isotope-labelled leucin. Group 2A (patients with brain trauma, acute hydrocephaly) : continuous collection of CSF, for 24 to 36 hours
16086211|NCT02263222|Drug|MDT-10013|
16086212|NCT02263209|Device|Bioguard Group|Patients randomised to receive the study investigative device will receive a Bioguard implant
16086213|NCT02263209|Device|Control Group|Patients randomised to receive the control device will receive a Exceed Taperlock implant
16086214|NCT02263196|Other|Alcohol and povidone iodine|using from Alcohol and povidone iodine for prevention of inflammation
16086215|NCT02263196|Other|combination of alcohol and betadin|using from combination Alcohol and povidone iodine for prevention of inflammation
16086216|NCT02263183|Dietary Supplement|Red Palm Olein|Red Palm Olein contains corresponding fatty acids like Palm Olein except having more phytonutrients (carotenoids and vitamin E)
16086217|NCT02263183|Dietary Supplement|Palm Olein|Palm Olein contains corresponding fatty acids like Red Palm Olein except having less phytonutrients (no carotenoids and less vitamin E)
16086218|NCT02263170|Other|MRI (magnetic resonance imaging)|Assessment of the sphincter morphology
16086219|NCT02263170|Other|US (ultra sound)|Assessment of the sphincter morphology
16086220|NCT02263170|Other|FLIP (functional luminal imaging probe)|Assessment of the biomechanical properties of the sphincter region
16086221|NCT02263170|Other|HRAM (high resolution anal manometry)|Assessment of the biomechanical properties of the sphincter region
16086222|NCT02263144|Procedure|virtual chromo-endoscopy using FICE Fujifilm Technology|For each polyps, any observer will use virtual chromo-endoscopy with FICE Fujifilm Technology
16086223|NCT02263131|Biological|IL-YANG FLU Vaccine Prefilled Syringe INJ.|IL-YANG FLU Vaccine Prefilled Syringe INJ.0.5mL or 0.25mL
16086224|NCT02263131|Biological|VAXIGRIP Prefilled Syringe INJ.|VAXIGRIP Prefilled Syringe INJ.0.5mL or 0.25mL
16086225|NCT02263118|Other|Uni-directional SMS|Exposure to breastfeeding promoting SMSs
16086226|NCT02263118|Device|Feature phone|Participants were given a feature phone.
16086227|NCT02263118|Other|Virtual communities|Exposure to virtual community communication via SMS
16086228|NCT02263118|Other|Hybrid setup|Exposure to virtual community and access to communications with health professional via SMS
16086229|NCT02263105|Drug|CDDP|
16086230|NCT02263105|Drug|Temozolomide|If hematologic and nonhematologic toxicity assessed according to the Common Terminology Criteria for Adverse Events (CTCAE; version 4.0) from the previous cycle had been grade 0 or 1, then TMZ dose escalation to was allowed to the maximum of 150 mg/m2. If grade 4 hematologic toxicity or grade 3 nonhematologic toxicity had occurred, then TMZ dose was reduced in 25 mg/m2 steps. If grade 4 nonhematologic toxicity occurred, patient treatment was halted. If grade 4 hematologic toxicity or grade 3 nonhematologic toxicity continued when TMZ dose was in the minimum of 75 mg/m2, patient treatment was halted.
16086231|NCT02263092|Behavioral|Physical exercise|The intensity of physical exercise will be determine by the maximum heart rate (max HR) using the formula (220 - age). For the high intensity, the intensity will between 79-95% xx% of maxHR; moderate intensity, 64-76% of maxHR; mild intensity, 57-63% of maxHR. Furthermore, during the physical exercise the heart rate will be continuous evaluate by the POLAR and the rate perceived scale will be register in each 3 minutes by the modified Borg scale
16086232|NCT02263092|Device|tDCS|Current will be applied by a DC stimulator (NeuroConn, Germany) using a pair of saline-soaked sponge electrodes (surface 35 and 36cm²). tDCS will be applied to Cz and Oz according to International 10-20 EEG system. In the anodal tDCS, the anode will be placed in Cz and cathode in Oz. In the cathodal tDCS the inverse position will be done. Parameters of current intensity and duration (dose) used were 2 mA stimulation intensity for 20 minutes with current ramping up and down of 10 seconds each.For sham, the same position of anodal tDCS will be assumed, however, current duration is only 30 seconds, with current ramping up and down of 10 seconds each. Moreover, the electrostimulation device is automatically turned off without patient's perception. Thus, patients experience early sensations (mild to moderate tingling) in stimulation site without inducing effect. Moreover, after each tDCS session, patients will answer adverse effects questionnaire.
16086233|NCT02263092|Behavioral|Rest|15 or 30 minutes seat without move the legs
16086289|NCT02262663|Drug|Vilaprisan (BAY1002670)|
16086290|NCT02262650|Drug|Telmisartan|
16086236|NCT02263079|Drug|Pegylated Interferon Alfa-2A|Participants will receive pegylated interferon-alfa-2A at a body surface area (BSA) based dose of 180 micrograms per 1.73 square meter (mcg/1.73m^2) BSA.
16086237|NCT02263066|Biological|BAY14-2222_Kogenate-FS FVIII|Depends on Doctor's decision
16086238|NCT02263053|Procedure|POSTERIOR MOBILIZATION|Patient supine on the gurney, previously trained physiotherapist with disposable gloves, one hand place your thumb on the lower lateral incisors and canines. Applies a force previous distraction grade III and performs oscillating for 1 minute.
16086239|NCT02263053|Procedure|CAUDAL MOBILIZATION|Patient supine on the gurney, previously trained physiotherapist with disposable gloves, one hand place your thumb on the lower molars of patients. Apply simultaneous flow and force the previous direction, and performs the degree of oscillation III for 1 minute.
16086240|NCT02263040|Biological|Fluzone High-Dose|Influenza vaccine
16086241|NCT02263040|Biological|Fluzone (standard dose)|Influenza vaccine
16086242|NCT02263027|Biological|Vaccine|Licensed trivalent inactivated influenza vaccine
16086243|NCT02263014|Behavioral|Questionnaires|Screening questionnaire completed at baseline. Surgery decision questionnaires completed at surgical consult visit, and at 1, 6, 12, and 18 months after the surgery is completed.
16086244|NCT02263001|Other|Auricular acupuncture|Auricular therapy for treatment of musculoskeletal pain
16086245|NCT02263001|Other|Usual Care|Usual care therapy consists of over-the-counter and prescribed pharmacotherapy
16086246|NCT02262988|Procedure|Autologous cells and total knee arthroplasty|
16086247|NCT02262988|Procedure|Standard total knee arthroplasty surgery|
16086248|NCT02262962|Other|Redesigned Well-Child Care|The Well-Child Visits will be enhanced using a newly-designed model of care. Parents will have access to Parent Coach during child's routine well visits, Well Baby Help Line, Well-Visit Planner, and HealthyTxt Messaging service.
16086249|NCT02262949|Device|LifeStent Vascular Stent|PTA followed by implantation of the LifeStent Vascular Stent (stent length 250 mm) in the SFA or popliteal artery.
16086250|NCT02262936|Drug|Desmopressin|
16086251|NCT02262936|Drug|Fesoterodine|
16086252|NCT02262923|Drug|metoclopramide|
16086253|NCT02262910|Biological|ES414|ES414 is a novel humanized bispecific antibody which is designed to treat mCRPC by redirecting T-cell cytotoxicity against prostate cancer cells expressing prostate-specific membrane antigen (PSMA).
16086254|NCT02262897|Drug|Nab-paclitaxel|Nab-paclitaxel weekly chemotherapy 130mg/m2, d1,8,15,every 4 week or Nab-paclitaxel chemotherapy once a time with a dose of 230 mg/m2 every 3 weeks
16086255|NCT02262884|Device|SurgiQuest AirSeal Insufflation System (AIS)|Comparison between Conventional Insufflation System (CIS) and the SurgiQuest AirSeal Insufflation System (AIS) at similar pressures (15mmHg) and the SurgiQuest AirSeal at 12mmHg.
16086256|NCT02262884|Device|Conventional Insufflation System (CIS)|Comparison between Conventional Insufflation System (CIS) and the SurgiQuest AirSeal Insufflation System (AIS) at similar pressures (15mmHg) and the SurgiQuest AirSeal at 12mmHg.
16086257|NCT02262871|Device|High flow nasal oxygen cannula|HFN will be set with an inspiratory flow rate at 45-55 L/min (maximal tolerated flow), temperature at 37°C or 34°C if perceived as too warm, and fraction on inspired oxygen (FiO2) will be adjusted to achieve an oxygen saturation (SpO2) of at least 92%.
16086258|NCT02262871|Device|Noninvasive ventilation|The setting of NIV will be appropriately adjusted, based on the clinical assessment of the respiratory therapist in charge and will not be modified during the test.
16086259|NCT02262858|Drug|Telmisartan and HCTZ|
16086260|NCT02262858|Drug|Telmisartan|
16086261|NCT02262858|Drug|HCTZ|
16086262|NCT02262845|Device|The Advanix™ Pancreatic Stent and NaviFlex RX Pancreatic Delivery System and Pushers|Used to drain pancreatic ducts
16086263|NCT02262832|Drug|Metreleptin|administered subcutaneously 1-2 times/day
16086264|NCT02262819|Drug|S. aureus|S. aureus, commensal coagulase-negative staphylococcal species, and Gram-negative commensals, such as Roseomonas and Pseudomonas species
16086265|NCT02262806|Drug|Metreleptin|A leptin analog indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency in patients with partial lipodystrophy.
16086266|NCT02262793|Drug|telmisartan|
16086267|NCT02262793|Drug|ASA/ER-DP|
16086268|NCT02262780|Drug|Low dose of telmisartan|
16086269|NCT02262780|Drug|High dose of telmisartan|
16086270|NCT02262780|Drug|HCTZ|
16086271|NCT02262767|Drug|PF-06649751|Experimental Pfizer compound.
16086272|NCT02262767|Drug|Trimethobenzamide Hydrochloride|Trimethobenzamide Hydrochloride is indicated for the treatment of postoperative nausea and vomiting and for nausea associated with gastroenteritis.
16086273|NCT02262754|Drug|PF-06372865|Dose level 1 daily dosing BID for 1 week followed by dose level 2 daily BID for 3 weeks
16086274|NCT02262754|Drug|Placebo|Placebo for PF-06372865 and placebo for naproxen daily
16086275|NCT02262754|Drug|Naproxen|500 mg BID for 4 weeks
16086276|NCT02262741|Biological|MEDI4736|MEDI4736 will be administered by IV infusion in combination with tremelimumab.
16086277|NCT02262741|Biological|tremelimumab|Tremelimumab will be administered by IV infusion in combination with MEDI4736.
16086278|NCT02262728|Drug|Simeprevir|Simeprevir 150 milligram (mg) capsule orally once daily for 12 weeks
16086279|NCT02262728|Drug|Daclatasvir|Daclatasvir 60 mg tablet orally once daily for 12 weeks
16086280|NCT02262728|Drug|Sofosbuvir|Sofosbuvir 400 mg tablet orally once daily for 12 weeks
16086281|NCT02262715|Drug|VX-787|Participants will receive VX-787, 600 mg either two times a day or once a day in either of the Part.
16086282|NCT02262715|Drug|Oseltamivir|Participants will receive Oseltamivir 75 mg either two times a day or once a day in either of the Part.
16086283|NCT02262715|Other|Placebo|Participants will receive placebo matching to VX-787 either two times a day or or once a day.
16086284|NCT02262702|Drug|Paracetamol 665 mg|Paracetamol 665 mg tablet
16086285|NCT02262702|Drug|Paracetamol 500 mg|Paracetamol 500 mg tablet
16086286|NCT02262689|Drug|GSK2256294|GSK2256294 will be supplied as gelatin capsule to be administered orally with the unit dose 5 mg / dose level 15 mg
16086287|NCT02262689|Drug|Placebo|Matched Placebo will be supplied as gelatin capsule to be administered orally
16086291|NCT02262650|Drug|Clopidogrel|
16086300|NCT02262598|Drug|Hydrochlorthiazide (HCTZ)|
16086301|NCT02262598|Drug|Telmisartan/HCTZ fixed dose|
16086302|NCT02262585|Drug|BIBR 277 tablet|
16086303|NCT02262585|Drug|BIBR 277 capsule|
16086304|NCT02262572|Drug|Telmisartan /HCTZ - compression tablet (DC)|
16086305|NCT02262572|Drug|Telmisartan /HCTZ - dry granulation tablet (DG)|
16086306|NCT02262572|Drug|Telmisartan /HCTZ - present commercial formulation|
16086307|NCT02262559|Drug|BIBR 277 tablet|
16086308|NCT02262559|Drug|BIBR 277 capsule|
16086309|NCT02262546|Drug|Pramipexole extended-release (ER) tablets|
16086310|NCT02262546|Drug|Pramipexole immediate-release (IR) tablets|
16086311|NCT02262546|Drug|Moxifloxacin|
16086312|NCT02262546|Drug|Pramipexole Placebo|
16086313|NCT02262546|Drug|Moxifloxacin Placebo|
16086314|NCT02262533|Drug|Apixaban|
16086315|NCT02262533|Drug|Atenolol|
16086316|NCT02262520|Drug|Apixaban|
16086317|NCT02262520|Drug|Digoxin|
16086318|NCT02262507|Device|Device Wearing|Q30 collar - collar designed to be worn around the neck to apply slight pressure to jugular veins. Each subject will undergo repeat oto-acoustic measures both wearing the device and not wearing the device
16086319|NCT02262494|Procedure|portable venous compression ultrasonography|venous compression ultrasonography performed using an ultra-portable ultrasound device (by emergency physician)
16086320|NCT02262494|Procedure|venous compress ultrasonography|venous compression ultrasonography performed using a classic ultrasound device (by exploratory specialist)
16086321|NCT02262494|Procedure|Doppler ultrasound of the lower limbs|Doppler ultrasound of the lower limbs (gold standard; by exploratory specialist)
16086322|NCT02262481|Drug|dydrogesterone|
16086323|NCT02262481|Drug|placebo|
16086324|NCT02262468|Radiation|x ray|
16086325|NCT02262455|Drug|STM 434|STM 434 will be administered by IV injection. There are five planned dose levels, from 0.25mg/kg to 4mg/kg, which is dependent on the cohort (group) a participant is assigned to.
16086326|NCT02262455|Drug|Liposomal doxorubicin|Liposomal doxorubicin (40 mg/m2) will be administered once every 28 days by IV infusion prior to STM 434 for those participants enrolled in Part 3 of the trial. Liposomal doxorubicin will be administered for a maximum of 6 cycles (each cycle being 28 days).
16086327|NCT02262442|Device|Enk Fiberoptic Atomizer|Nebulization of local anesthetics with the Enk Fiberoptic Atomizer by Cook Medical during the flexible bronchoscopy
16086328|NCT02262442|Device|bronchoscope|Standard procedure: Administration of local anesthetics via the working channel of the bronchoscope during the flexible bronchoscopy
16086329|NCT02262429|Other|ONS QIP|Rapid comprehensive ONS, dietary consult, follow up phone calls
16086330|NCT02262429|Other|ONS Standard Feeding|Standard of care
16086331|NCT02262416|Drug|leuprolide|normal saline
16086332|NCT02262403|Other|Blood and feces sampling|Blood and feces samples will be examined after 14 days, 28 days, 3 months and 16 months. This will require blood and feces sampling. The study is therefore defined as 'interventional' rather than 'observational' as it includes acts outside the standard of care.
16086333|NCT02262390|Procedure|Partner Notification Reminders|"For all 3 arms, the following will be done:
~All participants will have an antenatal clinic visit every 4 weeks until delivery.
~All notification slips will be duplicate; one given to the mother and one held in the clinic. The study ID number will be documented on the slip. On partner return the slips will be matched and used to link mothers with male returning partners.
~Partner participant test result will be linked to the patient using the participant ID number in the lab. Partners will be tested using a rapid treponemal antibody test."
16086334|NCT02262377|Behavioral|Integrative Medicine Group Visits|Patients with chronic pain and depression attend group medical visits and use website and virtual patient advocate as part of the curriculum.
16086335|NCT02262364|Biological|APS|See above
16086336|NCT02262351|Other|30 Second Pulse Check|To detect atrial fibrillation
16086337|NCT02262351|Device|Watch BP Home A|Blood pressure device that detects atrial fibrillation
16086338|NCT02262351|Device|HeartCheck Hand-held ECG device|To detect atrial fibrillation
16086339|NCT02262338|Drug|AGT-182|Recombinant HIRMAb-IDS
16086340|NCT02262325|Radiation|hypofractionated radiation therapy|Radiation boost in week 1 (days 1-5)
16086341|NCT02262325|Drug|cisplatin|Given IV
16086342|NCT02262325|Drug|etoposide|Given IV
16086343|NCT02262325|Radiation|3-dimensional conformal radiation therapy|Undergo 3-dimensional conformal radiation therapy
16086344|NCT02262325|Other|laboratory biomarker analysis|Correlative studies
16086345|NCT02262312|Other|Transient elastography|All patients will have a transient elastography performed as a measure of liver stiffness.
16086346|NCT02262299|Drug|Pirfenidone|Receive tablets with pirfenidone
16086347|NCT02262299|Drug|Placebo|Recieve tablets with placebo
16086348|NCT02262273|Other|Data Collection|Colleciton of data from medical records only
16086349|NCT02262260|Drug|Labeled regime arm|Treatment will be given monthly and will be continued until maximum visual acuity is achieved (the patient's visual acuity is stable for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter patients should be monitored monthly for visual acuity. Treatment will be resumed when monitoring indicates loss of visual acuity due to DME. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections). The interval between two doses should not be shorter than 1 month.
16086350|NCT02262260|Drug|Wait and Extend regime arm|Lucentis (ranibizumab) 0.5 mg will be injected subsequently at baseline, month 1 and 2. After the three initial loading doses, patients will be called for the control visits 1 month later. If the visual acuity has reached a stable level and there is no sign of edema on OCT, patients will not receive intravitreal injection and will be called to come back 6 weeks later. The interval is increased by 2 weeks until a maximum of 8 weeks as long as the patient presents as stable regarding visual acuity, central retinal thickness and clinical findings. If there is a negative change, the interval is shortened back to 4 weeks.
16086392|NCT02261961|Biological|TDAP|Both arms will receive the tetanus, diptheria, and pertussis vaccination after two weeks of treatment with supplement or placebo
16086513|NCT02261090|Drug|Pramipexole immediate release (IR) tablets|
16086351|NCT02262234|Other|Education Program Type 1|The first part of the education program involves four weeks of in-person classes (2 hours per class) given once per week with homework assignments of approximately 30 minutes per day for at least 5 days per week. The second part of the education program involves home-based activities only, performed approximately 30 minutes per day for at least 5 days per week.
16086352|NCT02262234|Other|Education Program Type 2|The first part of the education program involves four weeks of in-person classes (2 hours per class) given once per week with homework assignments of approximately 30 minutes per day for at least 5 days per week. The second part of the education program involves home-based activities only, performed approximately 30 minutes per day for at least 5 days per week.
16086353|NCT02262221|Other|Scheduled radiologic evaluations|Scheduled radiologic evaluations (CT or MRI scan) and PET scan in the case that patiets are ≥ 50 years old and with a smokink history ≥ 20 pack year
16086354|NCT02262208|Other|Aerobic Exercises|"Exercise intensity for each individual by a heart rate monitor (Polar F1 TM, Polar Electro Oy, Helsinki, Finland), and a Borg 0-10 scale used to register individuals' perceived exertion every 5 minutes throughout the experimental sessions.
~Aerobic session will consist of 40 min of lower limb bicycle at 70% of the peak heart rate, as determined in the incremental exercise test."
16086355|NCT02262208|Other|Eccentric Exercise|Eccentric session will consist of 40 min of one lower -limb exercises (leg press) with 6 sets of 10 repetitions at 120% of 1-RM.
16086356|NCT02262208|Device|Continuous glucose monitoring system (Guardian, Medtronic, Northridge, USA)|Subjects will be admitted to the laboratory in the morning at approximately 9:00 a.m., 24 h before the exercise session, when the glucose sensor (Sof-SensorTM, Medtronic Mini-Med, Northridge, USA) will be inserted subcutaneously. The sensor is a glucose oxidase based platinum electrode that is inserted through a needle into the subcutaneous tissue of the anterior abdominal wall, using a spring-loaded device (Senserter, Medtronic, Northridge, USA). Glucose profiles will be collected the day before (day 1), the day of (day 2), and the day following (day 3) and 40 min of exercise. Each sensor will be used continuously for up to 72 h.
16086357|NCT02262195|Other|Elevated levels of carboxyhemoglobin|Comparison of pulse co-oximeters
16086358|NCT02262182|Other|KP group|
16086359|NCT02262182|Other|KM group|
16086360|NCT02262169|Drug|Omeprazole|2 Omeprazole capsules 20 mg, once daily
16086361|NCT02262169|Drug|Placebo caplet of DLBS2411|1 placebo caplet of DLBS2411, twice daily
16086362|NCT02262169|Drug|DLBS2411|1 DLBS2411 caplet 250 mg, twice daily
16086363|NCT02262169|Drug|Placebo capsule of Omeprazole|2 placebo capsules of Omeprazole, once daily
16086364|NCT02262156|Other|Cognitive behavioral therapy|"The CBT group will receive 12 weekly 90-minute sessions. Each session will be given in group form by one certified CBT therapist and one neuropsychiatrist in training on group therapy.
~The CBT structure include psychoeducation, addressing dysfunctional thoughts and maladaptive behaviors; problem solving techniques, assertiveness, coping strategies and depression relapse prevention"
16086365|NCT02262156|Drug|SSRI|"Patients will receive the treatment as usual with a SSRI: sertraline or citalopram. In patients already taking antidepressants for more than 8 weeks before enrollment but still experiencing depressive symptoms, treatment could be optimized either by augmenting the dose of his antidepressant or by changing to one of the SSRI mentioned."
16086366|NCT02262143|Drug|Rosuvastatin|Rosuvastatin 10 mg, qd, po
16086367|NCT02262143|Drug|Fenofibrate|Fenofibrate 160mg, qd, po
16086368|NCT02262130|Drug|Omalizumab|
16086369|NCT02262117|Other|standard care|No specific medical care
16086370|NCT02262117|Drug|specific treatment|Regarding the immune endometrial profiling, medical care (personalization of treatment) should follow a step by step decision tree.
16086371|NCT02262104|Behavioral|Intensive exercise|Arm 1: Intervention group. Intensive strength exercise (12RM) for lower limb and balance exercises twice a week for 1 hour. Groups of max 3 participants lead by physiotherapist
16086372|NCT02262104|Behavioral|Control|Arm 2: control. Social activity group with light exercise, reading, and games. Lead by occupational therapist or nursing staff
16086373|NCT02262091|Dietary Supplement|Food fibers|
16086374|NCT02262091|Dietary Supplement|Maltodextrin|
16086375|NCT02262091|Biological|Influenza vaccine (incl. criterion)|
16086376|NCT02262078|Drug|Sodium Nitrite Inhalation Solution|90mg of (nebulized) inhaled sodium nitrite will be administered (by inhalation) to participants prior to exercise.
16086377|NCT02262078|Other|Placebo|Normal saline will be administered (by inhalation) to participants prior to exercise.
16086378|NCT02262052|Other|MRDTI|MRDTI is primary diagnostic test for management of suspected ipsilateral DVT
16086379|NCT02262039|Device|Valveless recirculating insufflation (VTI)|10 mmHg target pressure
16086380|NCT02262039|Device|Conventional pressure|15 mmHg target pressure
16086381|NCT02262026|Drug|125 mg AZD0530|Randomized to receive 125 mg of AZD0530
16086382|NCT02262026|Drug|50 mg AZD0530|Randomized to receive 50 mg of AZD0530
16086383|NCT02262026|Drug|Placebo|Placebo
16086384|NCT02262013|Behavioral|Parents as Coaches|Adolescents will receive lifestyle intervention (TEENS) and parents will receive parents as coaches (PAC) intervention.
16086385|NCT02262013|Behavioral|Parent Weight Loss|Adolescents will receive lifestyle intervention (TEENS) and parents will receive parent weight loss (PWL) intervention.
16086386|NCT02262000|Radiation|Image Guided Stereotactic Ablative Radiotherapy|
16086387|NCT02261987|Other|Autogenic drainage (AD)|It will be apply in one only session. The time spent during this bronchial drainage session will be 30 minutes All patients will perform all interventions in a randomized order.
16086388|NCT02261987|Other|Resistive inspiratory manoeuvre (RIM)|It will be apply in one only session. The time spent during this bronchial drainage session will be 30 minutes All patients will perform all interventions in a randomized order.
16086389|NCT02261987|Other|Resistive inspiratory manoeuvre+autogenic drainage|It will be apply in one only session. The time spent during this bronchial drainage session will be 30 minutes All patients will perform all interventions in a randomized order.
16086390|NCT02261974|Device|Active Treatment Viveve|Subject will receive 90 Joules/cm2 radiofrequency energy to the vaginal introitus
16086391|NCT02261974|Device|Sham Treatment Viveve|Subject will receive ≤ one (1) Joule of radiofrequency energy to the vaginal introitus
16086508|NCT02261090|Drug|Formulation D: Pramipexole Slow release tablet|
16086393|NCT02261961|Other|Acute Resistance Exercise|Both arms will receive a single bout of resistance exercise twice, before and after two weeks of treatment with supplement or placebo, and be evaluated for the response within blood and muscle
16086394|NCT02261961|Other|Resistance Exercise Training|Both arms will receive 36 sessions of progressive high-intensity resistance exercise training (thigh muscle) over the course of approximately 12 weeks.
16086395|NCT02261961|Other|Post-training Follow-up|Both arms will continue to receive treatment with supplement or placebo for approximately 26 weeks after completion of the exercise training. During this time subjects will not be allowed to perform resistance exercise.
16086396|NCT02261961|Dietary Supplement|Nutritional Supplement (Muscle Armor)|Subjects in the supplement group will consume orange-flavored Muscle Armor according to the manufacturer's directions: one serving (approximately 30g, i.e. one scoop provided with the product by its manufacturer), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.
16086397|NCT02261961|Dietary Supplement|Placebo (Kool-Aid)|Subjects in the placebo group will consume orange-flavored Kool-Aid (Kraft Foods) according to the manufacturer's directions: one serving (approximately 13g, i.e. one scoop provided with the product by the pharmacy), twice daily mixed with 12 ounces (oz) of water beginning after all baseline assessments are performed including assessment of the response to acute exercise and continuing until the end of study participation.
16086398|NCT02261948|Drug|Levosimendan|Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min.
16086399|NCT02261948|Drug|Placebo|Treatment should be initiated with a loading dose of 6-12 mcg / kg infused over 10 minutes followed by a continuous infusion of 0.1 mcg / kg / min.
16086400|NCT02261935|Other|Existing home care nursing practice|"Home care nurses in this comparator group will provide care as per usual to their patients and family caregivers. The family is seen as the unit of care but no formal assessment of the caregiver will be done."
16086401|NCT02261935|Other|Practice support tool intervention|"The intervention will be the routine use of the Carer Support Needs Assessment Tool (CSNAT) in the practice of home care nurses (once every 4 weeks with each family caregiver) to document, monitor and address family caregiver support needs.
~The completed CSNAT tool will be kept in the patient chart and will be integrated into the care provided by the nurse.
~Update - December 22, 2016 - In some offices only, the CSNAT will be administered by a separate study nurse. Findings will be communicated to the home care nurse to inform the documenting, monitoring and addressing of family caregiver support needs."
16086402|NCT02261922|Drug|ticagrelor|
16086403|NCT02261922|Drug|prasugrel|
16086404|NCT02261896|Drug|Placebo|Evaluate usefullness of antibiotic prophylaxis
16086405|NCT02261896|Drug|Ciprofloxacin|Ciprofloxacine 400 mg intravenous one dose followed by ciprofloxacine oral each 12 hours (complete 3 days)
16086406|NCT02261883|Drug|IV Remodulin|Treprostinil is a chemically stable tricyclic analogue of prostacyclin.
16086407|NCT02261883|Drug|Placebo|matching placebo
16086408|NCT02261870|Device|MRI T2 quantification|MRI acquisitions will be performed according to the already described method based on conventional Fast Spin Echo sequences and with an additional calibration pad positioned on the patient thorax (dedicated pad made by the Nancy CIC-IT with stable and adapted T2). MRI will be performed if possible before the biopsy and otherwise the radiologist will be kept blinded of the biopsy results.
16086409|NCT02261857|Device|Personalized continuous positive airway pressure (CPAP) mask|Personalized CPAP mask manufactured for study subjects using a combination of patient-specific computer-aided design and three-dimensional printing
16086410|NCT02261844|Dietary Supplement|Resveratrol|Resveratrol 1 gm po x 10 days prior to liver resection
16086411|NCT02261844|Drug|Placebo|Placebo 1 pill daily X 10 days
16086412|NCT02261831|Other|obese patients|collection of blood sampling and biopsies
16086413|NCT02261831|Other|diabetic patients|collection of blood sampling and biopsies
16086414|NCT02261831|Other|patients free of obesity and diabetes|collection of blood sampling and biopsies
16086415|NCT02261831|Other|patients free type 2 diabetes|collection of blood sampling and biopsies
16086416|NCT02261818|Behavioral|Meetings with peer mentors|Peer mentors provide social support to address depressive symptoms
16086417|NCT02261805|Drug|Ganetespib|
16086418|NCT02261805|Drug|Doxorubicin|
16086419|NCT02261792|Procedure|24 hours Trendelenburg position|Trendelenburg position
16086420|NCT02261792|Procedure|24 hours bed rest|24 hours bed rest after EBP
16086421|NCT02261792|Procedure|EBP|Autologous Epidural Blood Patch
16086422|NCT02261779|Drug|Tranylcypromine|
16086423|NCT02261779|Drug|Tretinoin|
16086424|NCT02261766|Device|Holter monitoring and Thumb ECG|5 days holtermonitoring and 30 days 30 seconds twice daily thumb ECG recording
16086425|NCT02261753|Dietary Supplement|Classical ketogenic diet|A high fat low carbohydrate, low protein diet.
16086426|NCT02261740|Behavioral|Yoga Therapy|"A 90-minute orientation session led by the yoga class instructors, followed by 90-minute group yoga classes twice weekly for 6 weeks. Classes will be led by an experienced instructor. Women will also be taught to avoid any habits that may worsen their genito-pelvic pain (e.g., straining their pelvic floor muscles).
~Participants will also be asked to practice yoga at home an additional hour per week throughout the 6-week yoga therapy program. Participants will be given a detailed written manual to use for home practice."
16086427|NCT02261727|Drug|Theophylline|Theophylline is an oral methylxanthine which relaxes smooth muscle through its action as a phosphodiesterase inhibitor
16086428|NCT02261727|Drug|Prednisone|Prednisone is an oral glucocorticosteroid which has anti-inflammatory properties
16086429|NCT02261727|Drug|Placebo (for prednisone)|"Arm 1 : Theophylline Placebo 1 tab twice daily and Prednisone placebo 1 tab once daily
~Arm 2 : Theophylline 100mg 1 tab twice daily and Prednisone placebo 1 tab once daily"
16086430|NCT02261727|Drug|Placebo (for Theophylline)|One tablet twice daily in arm 1 (theophylline placebo 1 BD + prednisone placebo 1 once daily)
16086509|NCT02261090|Drug|Formulation E: Pramipexole Slow release tablet|
16086510|NCT02261090|Drug|Formulation F: Pramipexole Slow release tablet|
16086511|NCT02261090|Drug|Formulation G: Pramipexole Slow release tablet|
16086512|NCT02261090|Drug|Formulation H: Pramipexole Slow release tablet|
16086431|NCT02261714|Biological|TG01|"TG01 and GM-CSF will be administered on days 1, 8, 15, 22 and 36. TG01 alone will also be given on days 36 and 50 for DTH assessment. Gemcitabine will start at least 3 weeks after TG01/GM-CSF and will be given on days 1, 8 and 15 of a four-weeks cycle up to 6 cycles in total.
~Once chemotherapy is completed, GM-CSF and TG01 injections will resume and will be given every 4 weeks from the end of the chemotherapy period up to week 52 (plus once at week 5 post-chemotherapy) and then every 12 weeks from week 52 to week 104. TG01 alone will be given 8 weeks after the end of chemotherapy for DTH assessment.
~TG01 will be given at a dose of 0.70 mg/injection and GM-CSF will be given at a dose of 30 micrograms both as intradermal injections.
~Gemcitabine will be given at a dose of 1000 mg/m2 iv over 30 minutes"
16086432|NCT02261714|Biological|TG01|"For patients not able to start TG01 quickly after surgery, the vaccination can start at the same time as the chemotherapy as long as they start within 12 weeks from surgery. Gemcitabine will start at the same time as TG01/GM-CSF and will be given on days 1, 8 and 15 of a four-weeks cycle up to 6 cycles in total.
~TG01 will be given at a dose of 0.70 mg/injection and GM-CSF will be given at a dose of 30 micrograms both as intradermal injections.
~Gemcitabine will be given at a dose of 1000 mg/m2 iv over 30 minutes"
16086433|NCT02261701|Other|Early mobilization|Early mobilization, collar´n cuff 4 weeks post surgery and after this light exercises start and no further bandage.
16086434|NCT02261701|Other|Post surgery shoulder lock|Post surgery: Shoulder lock with abduction cushion, additionally 3 weeks with collar´n cuff, and after this period light exercises are allowed and nu further bandage.
16086435|NCT02261688|Dietary Supplement|Low salt diet|Low salt diet, 10mmoL of sodium per day, for 6 days
16086436|NCT02261688|Dietary Supplement|Low salt diet + IV normal saline|Low salt diet, 10 mmoL of sodium per day, for 4 days with normal saline infusion x 12 hours per day for 200 mmoL of sodium chloride. Total daily sodium is 210 mmoL/day.
16086437|NCT02261688|Dietary Supplement|Liberal salt diet|Liberal salt diet targeting 200 mmoL of sodium per day x 7 days
16086438|NCT02261675|Drug|dexmedetomidine|children received intravenous infusion with a bolus dose dexmedetomidine and followed by a continuous infusion before induction. use sevoflurane for induction and a steady-state end-tidal sevoflurane concentration was maintained for at least 15 min before skin incision.
16086439|NCT02261662|Drug|Ribavirin|"A nucleoside antimetabolite antiviral agent that blocks nucleic acid synthesis and is used against both RNA and DNA viruses.
~It will be used along with Topical steroids; Betamethasone"
16086440|NCT02261662|Drug|Betamethasone|Topical Steroids alone will be used; Betamethasone
16086441|NCT02261649|Device|Medoc Advanced Medical Systems PATHWAY Model ATS|30 minutes of sensory testing using a contact thermal stimulator will measure thresholds for heat and cool detection, and threshold for hot and cold pain.
16086442|NCT02261649|Procedure|Cold water bath|The next 15 minutes of sensory testing will measure tolerance to having right or left hand in a tub of cold water. The participant will place their hand in cold water and leave it there for as long they can, even if it is uncomfortable. The participant can take their arm out if it gets too uncomfortable to leave it in.
16086443|NCT02261649|Device|MRI scanner|An MRI will be used to collect anatomical and functional images from patients and subjects. These data will be collected within a 1 hour block.
16086444|NCT02261649|Other|Questionnaires|The surveys include questions about emotions, thoughts, and feelings. These surveys will be given before sensory testing and before the MRI scan. The parent or guardian will help to complete two surveys, and will complete one survey on his or her own. Questions can be skipped, and may be stopped at any time.
16086445|NCT02261636|Drug|mesalazine|
16086446|NCT02261623|Device|WallFlex™ Biliary RX Fully Covered Stent System RMV|For use in the palliative treatment of biliary strictures produced by malignant neoplasms, and for treatment of benign biliary strictures
16086447|NCT02261623|Device|WallFlex™ Biliary RX Partially Covered Stent System|For use in the palliative treatment of biliary strictures produced by malignant neoplasms.
16086448|NCT02261623|Device|WallFlex™ Biliary RX Uncovered Stent System|For use in the palliative treatment of biliary strictures produced by malignant neoplasms.
16086449|NCT02261610|Procedure|Procalcitonin algorithm|Procalcitonin algorithm (usually used for lower respiratory tract) guide antibiotic therapy
16086450|NCT02261597|Behavioral|Cold Pressor Test|Repeated immersion of hand in ice-cold water
16086451|NCT02261584|Device|Microwave Thermal Coagulation|Microwave thermal coagulation of splenic parenchyma.
16086452|NCT02261584|Device|Partial Splenic Embolization|Femoral artery approach will be used for splenic artery catheterization with the tip of the catheter always well advanced selectively into the splenic artery. Embolizing agent will be injected in small increments. Arteriography in between divided doses will be done to document the extent of devascularization.
16086453|NCT02261571|Other|Moxibustion|"In the moxibustion treatment group, 3 moxibustion, 3 acupoints(CV12, CV8, CV54) will be heated with indirected moxibustion.
~The moxibustion will be removed when the patient feel hotness and require remove them"
16086454|NCT02261558|Other|Clinical Improvisation Instrumental Music Therapy|Select an instrument of choice (and instruments for caregiver/s if applicable) Play/improvise and expand playing 10 minutes, inclusive of clinical improvisation (melody, harmony, timbre, and rhythmic idioms) where musical communication will be fostered and therapeutic goals will be addressed by the therapist in the music. Closure through verbal reflection and sharing (5 minutes)
16086455|NCT02261558|Other|Clinical Vocal Improvisation|* 5 minutes of warm up. Select a few favorite songs of choice. Play/improvise and expand playing 10 minutes, inclusive of clinical improvisation (melody, harmony, timbre, and rhythmic idioms) where musical communication will be fostered and therapeutic goals will be addressed by the therapist in the music. Identify themes and issues addressed and/or paralleled in the song and/or within the self Closure through verbal reflection and sharing (5 minutes)
16086456|NCT02261545|Dietary Supplement|n-3 Fatty Acid|n-3 Fatty Acid supplement, 3 × 1000 mg softgel daily (2700 mg EPA+DHA per day), 3 times a day, for 10 weeks.
16086457|NCT02261545|Dietary Supplement|Placebo|3 cap 1 g Placebo(paraffin) per day for 10 weeks. Control Group: n-3 Fatty Acid placebo softgel (Containing 3 g edible paraffin oil), 3 × 1000 mg softgel daily (3 g per day), 3 times a day, for 10 weeks.
16086458|NCT02261532|Drug|TAS-102|TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.
16086459|NCT02261519|Drug|NaBen®|500 mg twice daily (1000 mg total)
16086460|NCT02261519|Other|Placebo|0 mg twice daily (0 mg total)
16086461|NCT02261506|Other|7 days of adequate antibiotic treatment durations|We will not be randomizing patients to any specific antibiotic regimen. Patients will be randomized to fixed durations of adequate treatment: 7 versus 14 days. The selection of antibiotic(s) will be at the discretion of the treating team, although the research team will check to ensure that the selected antibiotics have an 'adequate' spectrum of coverage for the bacterial pathogen(s) isolated in the blood culture.
16086462|NCT02261506|Other|14 days of adequate antibiotic treatment durations|
16086463|NCT02261493|Biological|OnabotulinumtoxinA|OnabotulinumtoxinA injected into the protocol-specified areas. Subjects will receive at least 1 and up to 3 treatments.
16086464|NCT02261493|Drug|Normal Saline|Placebo (normal saline) injected into the protocol-specified areas on Day 1.
16086465|NCT02261480|Other|Blood draw|When possible, blood will be drawn as an extra aliquot utilizing the same needle stick procedure performed for standard of care.
16086466|NCT02261480|Other|Nasopharyngeal wash|Nasopharyngeal washes are optional for Group A and Group B participants. Nasopharyngeal washes will be performed on all subjects in Group C. The technique used will be the same as used for regular standard of care per St. Jude guidelines.
16086467|NCT02261467|Biological|OnabotulinumtoxinA|OnabotulinumtoxinA injected into the protocol-specified areas. Subjects will receive at least 1 and up to 3 treatments.
16086468|NCT02261467|Drug|Normal Saline|Placebo (normal saline) injected into the protocol-specified areas on Day 1.
16086469|NCT02261454|Other|Gum chewing|1 piece of sugarless gum three times daily to be chewed for 1 hour each time.
16086470|NCT02261441|Other|Observational and noninterventional study|No specific recommendations will be provide to physicians about treatments. As a result, treatments of patients will be prescribed, modified or withdrawn according only to physicians´ judgment.
16086471|NCT02261428|Device|Catheter Tiemann|We tested the ability of Tiemann catheter to access trachea in order to aspirate bronchial secretions in ICU patients
16086472|NCT02261428|Device|Suction catheter|We tested the ability of Suction catheter to access trachea in order to aspirate bronchial secretions in ICU patients
16086473|NCT02261415|Drug|Tranexamic acid (TXA)|1 g TXA bolus injection + 1 g TXA infusion from induction over 8 hours
16086474|NCT02261415|Drug|Normal saline|1 g saline bolus injection + 1 g saline infusion from induction over 8 hours
16086475|NCT02261402|Other|Medisinstart|"Medisinstart is a newly developed pharmacy service for patients about to start a new medicine for a chronic or long-term condition. It consists of two follow-up consultations with a pharmacist. The first at 1-2 weeks and the second at 3-5 weeks after start of the new medicine."
16086476|NCT02261389|Other|Arm B, tumor markers assessment|Tumor markers assessment every three months through the study or until disease recurrence
16086477|NCT02261376|Drug|DS-1971a|DS-1971a is supplied as a powder or crystals and will be given as an oral suspension with Bitrex® (taste masking agent). Each subject will receive a single oral dose of 200 mg DS 1971a .
16086478|NCT02261350|Dietary Supplement|Food fortification|
16086479|NCT02261350|Dietary Supplement|Oral Nutritional Supplements|
16086480|NCT02261311|Other|Quality of Life|All participants recruited will complete a questionnaire prior to their breast biopsy and then again approximately one week before their surgery. The questionnaire is focused on the level of anxiety patients experience during the wait time between diagnosis and surgery. Additional tissue will be collected at the time of the diagnostic biopsy.
16086481|NCT02261298|Drug|ONO-4538|
16086482|NCT02261285|Drug|ONO-4538|
16086483|NCT02261272|Behavioral|CBT for insomnia SHUTi|SHUTi
16086484|NCT02261272|Behavioral|passive patient education/sleep hygiene|
16086485|NCT02261259|Procedure|Osteopathic manipulative treatment|Up to 4 sessions of osteopathic manipulative treatment (once per week)
16086486|NCT02261246|Procedure|Spinal manipulation treatment|Up to 4 sessions of spinal manipulation treatment (once per week).
16086487|NCT02261233|Procedure|Osteopathic manipulative treatment|Up to 4 sessions of osteopathic manipulative treatment (once per week)
16086488|NCT02261220|Biological|MEDI4736|MEDI4736 is administered by IV infusion in combination with tremelimumab
16086489|NCT02261220|Biological|tremelimumab|Tremelimumab is administered by IV infusion in combination with MEDI4736
16086490|NCT02261207|Drug|Axitinib|Axitinib will be administered at the dose of 5mg twice a day, continuously. Treatment will be continued till evidence of progression, or toxicities or patient withdrawal.
16086491|NCT02261194|Behavioral|Self-Care Tools|
16086492|NCT02261181|Device|XONRID|The patients will be treated with XONRID + standard of care (SOC) preemptive treatment adopted during radiation treatment for head and neck cancer patients. Patients will be instructed to apply the study cream (XONRID) on the irradiated area two times daily, the first application 1-2 h after the morning radiotherapy session, the second in the evening, starting on the first day of irradiation and continuing until 2 weeks after the completion of the radiation treatments or the development of Grade 3 or 4 skin toxicity. When G3 toxicity will occur the patient will be discontinued from the study medication and the skin toxicity will be managed according to internal guidelines.
16086493|NCT02261168|Other|Standardized living protocol|Subjects stay at the research facility for 44 hours and adhere to a standard sleeping, eating and activity protocol. During this protocol, multiple measurements will be performed including skeletal muscle biopsies (m. vastus lateralis), blood draws, indirect calorimetry and MRS measurements.
16086494|NCT02261155|Procedure|Hypnosis|hypnotic Relaxation without specific analgesic suggestion
16086495|NCT02261142|Device|Multifocal TENS garment (Mollii®)|Multifocal transcutaneous electrical stimulation incorporated into a whole-body garment in combination with training
16086496|NCT02261129|Drug|Telmisartan film-coated tablet|
16086497|NCT02261129|Drug|Telmisartan uncoated tablet|
16086498|NCT02261116|Drug|Telmisartan|
16086499|NCT02261116|Drug|Candesartan|
16086500|NCT02261116|Drug|Placebo|
16086501|NCT02261103|Drug|Pramipexole ER tablets|
16086502|NCT02261103|Drug|Pramipexole IR tablets|
16086503|NCT02261103|Drug|Placebo matching Pramipexole ER tablets|
16086504|NCT02261103|Drug|Placebo matching Pramipexole IR tablets|
16086505|NCT02261103|Other|Standard high-fat breakfast|
16086506|NCT02261090|Drug|Formulation B: Pramipexole Slow release (SR) tablet|
16086507|NCT02261090|Drug|Formulation C: Pramipexole Slow release tablet|
16086514|NCT02261077|Drug|Hyoscine butylbromide|
16086515|NCT02261077|Drug|Placebo|
16086516|NCT02261064|Drug|Telmisartan/Amlodipine low dose|
16086517|NCT02261064|Drug|Telmisartan/Amlodipine high dose|
16086518|NCT02261064|Other|Japanese meal|
16086519|NCT02261051|Other|Standard of care|Patients will be cared for using current standard of care preceding the design and implementation of the LCCM model of care.
16086520|NCT02261038|Other|Kanekasu radiographs|No interventions are performed here. All patients undergo CT and special radiographs of the knee to assess femoral TKA rotation.
16086521|NCT02261025|Drug|acetylsalicylic acid|75-100mg,per day
16086522|NCT02260986|Drug|Dupilumab|Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
16086523|NCT02260986|Drug|Placebo (for Dupilumab)|Subcutaneous injection in the different quadrants of the abdomen (avoiding navel and waist areas) and upper thighs
16086524|NCT02260986|Other|Topical Corticosteroid (TCS)|All participants were required to treatment with a (TCS) using a standardized regimen. It was recommended that participants use triamcinolone acetonide 0.1% cream or fluocinolone acetonide 0.025% ointment for medium potency, and hydrocortisone 1% cream for low potency.
16086525|NCT02260973|Dietary Supplement|Omega-3 (Triglyceride form)|
16086526|NCT02260960|Dietary Supplement|Omega-3 (Triglyceride form)|
16086527|NCT02260947|Drug|PF-06273340|PF-06273340 50 mg
16086528|NCT02260947|Drug|PF-06273340|PF-06273340 400 mg
16086529|NCT02260947|Drug|Pregabalin|Pregabalin 300 mg
16086530|NCT02260947|Drug|Ibuprofen|Ibuprofen 600 mg
16086531|NCT02260947|Drug|Placebo|Matching Placebo
16086532|NCT02260934|Biological|Rituximab|Rituximab 1000mg intravenously (IV) at week 0 and week 2
16086533|NCT02260934|Drug|Cyclophosphamide|Cyclophosphamide (750 mg) intravenously (IV) at week 0 and week 2.
16086534|NCT02260934|Drug|Prednisone|"Week 0 and Week 2: Prednisone (40 mg/day; taper to 10 mg/day by week 12)
~Continue prednisone 10 mg/day to week 96"
16086535|NCT02260934|Drug|Methylprednisolone|"Week 0 and Week 2:
~Solumedrol (100 mg) IV"
16086536|NCT02260934|Drug|Diphenhydramine|Diphenhydramine (50 mg, or equivalent dose of similar antihistamine) will be given orally 1 hour (plus or minus 15 minutes) before each infusion of rituximab.
16086537|NCT02260934|Drug|Acetaminophen|Acetaminophen (650 mg) will be given orally 1 hour (plus or minus 15 minutes) before each infusion of rituximab.
16086538|NCT02260934|Biological|Rituximab|Rituximab 1000mg intravenously (IV) at week 0 and week 2.
16086539|NCT02260934|Drug|Cyclophosphamide|Cyclophosphamide (750 mg) intravenously (IV) at week 0 and week 2.
16086540|NCT02260934|Drug|Prednisone|"Week 0 and Week 2: Prednisone (40 mg/day; taper to 10 mg/day by week 12)
~Continue prednisone 10 mg/day to week 96"
16086541|NCT02260934|Drug|Methylprednisolone|Week 0 and Week 2: Solumedrol (100 mg) IV
16086542|NCT02260934|Drug|Diphenhydramine|Diphenhydramine (50 mg, or equivalent dose of similar antihistamine) will be given orally 1 hour (plus or minus 15 minutes) before each infusion of rituximab.
16086543|NCT02260934|Drug|Acetaminophen|Acetaminophen (650 mg) will be given orally 1 hour (plus or minus 15 minutes) before each infusion of rituximab.
16086544|NCT02260934|Biological|Belimumab|The RCB Group will receive IV belimumab 10mg/kg at weeks 4, 6, 8, and then every 4 weeks through week 48
16086545|NCT02260921|Device|iovera°|
16086546|NCT02260921|Device|Sham Comparator|
16086547|NCT02260908|Drug|Enoxaparin|Enoxaparin 30 mg subcutaneously twice daily for six doses, starting 36-48 hours post-traumatic injury.
16086548|NCT02260908|Other|Placebo|0.9% normal saline in equal volume to active comparator given subcutaneously twice daily for six doses, starting 36-48 hours post-traumatic injury.
16086549|NCT02260895|Dietary Supplement|Almond pre-test snack|unsalted, dry-roasted almonds, 1/2 oz (14 g), ingested 30 minutes prior to the start of a two-hour oral glucose tolerance test
16086550|NCT02260882|Biological|PNEUMOVAX™ 23|PNEUMOVAX™ 23 (23-Valent Pneumococcal Polysaccharide Vaccination, V110, PPV23)
16086551|NCT02260869|Procedure|Genicular nerve radiofrequency ablation|Radiofrequency ablation uses the electrical field generated by a radiofrequency probe inserted near a nerve responsible for pain. Chronic pain sensation in the knee is generated at the genicular nerves. The physician locates the affected genicular nerve by injecting an anesthetic (lidocaine) that produces a sensory nerve block (i.e. anesthetic pain relief). A radiofrequency probe is inserted percutaneously near the affected nerve using a cannula/introducer and is then connected to a radiofrequency generator. This is set to stimulate sensory and motor response, which allows the physician to adjust the probe position for effective and safe treatment. Then radiofrequency is applied to the tissue for a short time (up to 150 seconds) in order to generate a target temperature (no more than 80 degrees Celsius). The increase in the temperature of the tissue ablates the affected nerve producing pain relief.
16086552|NCT02260869|Device|Pain Management Radiofrequency Kit|The pain management radiofrequency consists of a radiofrequency generator, a radiofrequency probe and an introducer/cannula. The introducer cannula is used to percutaneously position the probe in the appropriate location for treatment. The radiofrequency probe is an electrode that delivers the electric field that heats up the tissue. In cooled radiofrequency the electrode is surrounded by a water jacket that cools it while heat is generated. The generator is the instrument that provides the radiofrequency according to a particular temperature and time program. Temperature, tissue impedance and radiofrequency power are lalso monitored by the generator.
16086553|NCT02260856|Device|Tantalum Beads & Injector|To measure growth at physis, four tantalum beads will be implanted per physis at baseline and take radiostereometric analysis measurements at all follow up timepoints. Tantalum beads have been used to make detailed three dimensional radiographic measurements in orthopedic and other specialties
16086554|NCT02260856|Procedure|Percutaneous Drill Epiphysiodesis|
16086555|NCT02260856|Procedure|Percutaneous Screw Epiphysiodesis|
16086556|NCT02260843|Other|Generic Fitness|Subjects in this group will receive three fitness lessons in a week while each session last for 1 hour for 12 weeks
16086557|NCT02260843|Other|Tai Chi Intervention|Subjects in this group will receive three tai chi lessons in a week while each session last for 1 hour for 12 weeks
16086558|NCT02260830|Drug|Lu AF11167|
16086597|NCT02260583|Device|extracorporeal CO2 device|An ECCO2R device based on a modified continuous venovenous hemofiltration system will be used
16086559|NCT02260817|Drug|11C-choline Injection|"Choline C11 Injection for PET/CT Imaging Protocol:
~15 - millicuries (mCi) 11C-choline IV Injection
~PET images skull base to mid thigh with 3 min per bed position
~Use of IV contrast based on American College of Radiology (ACR) IV contrast guidelines for a renal function screening protocol
~Fusion of PET and CT images
~Choline C11 Injection for PET/MRI Whole Body Imaging Protocol:
~No IV contrast
~High resolution axial T2 prostate bed, axial Diffusion Weighted Image (DWI) pelvis, coronal T2 skull base to mid thighs
~Fusion of coronal and PET images"
16086560|NCT02260804|Biological|CT-P10|375mg/m2, IV on day1 of 4 cycles in induction period, and 12 cycles in maintenance period.
16086561|NCT02260804|Biological|Rituxan|375mg/m2, IV on day1 of 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.
16086562|NCT02260791|Drug|FKB327|Solution of FKB327 for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.
16086563|NCT02260791|Drug|Humira®|Solution of Humira® for subcutaneous injection administered in a dose of 40 mg every 2 weeks for 22 weeks.
16086564|NCT02260778|Behavioral|Learning Collaborative|A learning collaborative is an established technique that uses the model for improvement to bridge the gap between what we know and what we do. Structured learning sessions and collaborative coaching are used to guide small cycles of change called Plan-Do-Study-Act (PDSA) cycles. This quality improvement intervention will help providers adopt treat-to-target practices through the structured learning collaborative.
16086565|NCT02260765|Device|dTMS|The Brainsway H-Coil TMS device is intended for the treatment of depressive episodes in patients suffering from Major Depressive Disorder (MDD). The device technology is based on the application of deep TMS by means of repetitive pulse trains at a determined frequency
16086566|NCT02260752|Procedure|hysterectomy|surgical removal of the uterus
16086567|NCT02260752|Procedure|Uterine arterial embolization|In uterine artery embolization, doctor uses a slender, flexible tube (catheter) to inject small particles (embolic agents) into the uterine arteries, which supply blood to your fibroids and uterus.the embolic agents are injected into these fibroid blood vessels. The goal is to block the fibroid vessels, starving the fibroids and causing them to shrink and die.
16086568|NCT02260752|Procedure|myomectomy|surgical procedure to remove uterine fibroids, but does not remove uterus
16086569|NCT02260752|Drug|Medical Therapy|treatment of uterine fibroids with only medications, no procedure or surgery is used
16086570|NCT02260752|Procedure|endometrial ablation|surgical procedure that destroys uterine lining via a telescope placed inside the uterus
16086571|NCT02260752|Procedure|magnetic resonance guided focused ultrasound|procedure that destroys fibroids while inside an MRI machine
16086572|NCT02260752|Procedure|radiofrequency ablation|procedure that uses heat to destroy uterine fibroids
16086573|NCT02260739|Other|Blood samples|
16086574|NCT02260726|Procedure|Magnetic resonance imaging|
16086575|NCT02260726|Procedure|Ultrasound|
16086576|NCT02260713|Biological|autologous bone marrow cell|Transplantation of 200 million cells in 1.8 ml of autologous plasma in a single sitting. In case of intralesional route, the cells were delivered in one sitting at six sites ( 2 above the lesion, 2 at the lesion and 2 below the lesion) as 0.3 ml aliquots each. In case of Intrathecal route, the cells were delivered as a single injection of 1.8ml via lumbar puncture.
16086577|NCT02260700|Drug|JNJ-54861911 (Treatment A)|Participants will receive a single oral 25 mg dose of JNJ-54861911 as Treatment A (oral suspension formulation) under fasted conditions in one of the treatment periods.
16086578|NCT02260700|Drug|JNJ-54861911 (Treatment B)|Participants will receive a single oral 25 mg dose of JNJ-54861911 as Treatment B (solid formulation) under fasted conditions in one of the treatment periods.
16086579|NCT02260700|Drug|JNJ-54861911 (Treatment C)|Participants will receive a single oral 25 mg dose of JNJ-54861911 as Treatment C (solid formulation) under fed conditions in one of the treatment periods.
16086580|NCT02260687|Drug|Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)|Administration by intravitreal injection
16086581|NCT02260674|Drug|JNJ-54861911, 10 milligram (mg)|Participants will self-administer JNJ-54861911, two tablets of 5 mg each for a total of 10 mg, orally, once daily, from Day 1 until Month 6 in treatment group 1.
16086582|NCT02260674|Drug|JNJ-54861911, 50 mg|Participants will self-administer JNJ-54861911, two tablets of 25 mg each for a total of 50 mg, orally, once daily, from Day 1 until Month 6 in treatment group 2.
16086583|NCT02260674|Drug|Placebo|Placebo matched to JNJ-54861911, orally, once daily, from Day 1 until Month 6 in placebo group.
16086584|NCT02260661|Drug|AZD8835|AZD8835 is a small molecule that inhibits cancer progression by blocking PI3 kinase pathway components
16086585|NCT02260661|Drug|AZD8835|AZD 8835 is a small molecule that inhibits cancer progression by blocking PI3 kinase pathway components
16086586|NCT02260661|Drug|AZD8835 in combination with fulvestrant|AZD8835 is a small molecule that inhibits cancer progression by blocking PI3 kinase pathway components. Fulvestrant is approved for the treatment of postmenopausal women with ER+ locally advanced or metastatic breast cancer following progression of disease while receiving anti-estrogen therapy.
16086587|NCT02260661|Drug|AZD8835 in combination with fulvestrant|AZD8835 is a small molecule that inhibits cancer progression by blocking PI3 kinase pathway components. Fulvestrant is approved for the treatment of postmenopausal women with ER+ locally advanced or metastatic breast cancer following progression of disease while receiving anti-estrogen therapy
16086588|NCT02260648|Drug|Evacetrapib|Administered orally
16086589|NCT02260648|Drug|Ezetimibe|Administered orally
16086590|NCT02260648|Drug|Atorvastatin|Administered orally
16086591|NCT02260648|Drug|Placebo|Administered orally
16086592|NCT02260635|Drug|Evacetrapib|Administered orally
16086593|NCT02260635|Drug|Placebo|Administered orally
16086594|NCT02260622|Drug|rivaroxaban plus aspirin|Rivaroxaban 2.5 mg twice daily for 90 days (rivaroxaban will be started 6 to 8 hours after the finalization of the procedure) and 81 mg of ASA daily for 90 days
16086595|NCT02260622|Drug|clopidogrel plus aspirin|Clopidogrel 75 mg daily for 90 days (with a loading dose of 300 mg clopidogrel following PTA) and 81 mg of ASA daily for 90 days
16086596|NCT02260609|Other|Grafix®|"The treatment indication is for complex diabetic foot wounds with exposed tendon and/or bone that can accommodate up to three 5cm x 5cm pieces of Grafix®.
~Patients will be treated for up to 16 weeks.
~Patients will be evaluated at screening and then weekly throughout the study or until wound closure."
16086598|NCT02260570|Drug|Tolcapone|COMT Inhibitor
16086599|NCT02260570|Drug|Placebo|A pill that contains no active ingredient
16086600|NCT02260557|Drug|Selexipag|Film-coated tablets containing 200 μg of selexipag to be administered orally twice daily
16086601|NCT02260557|Drug|Placebo|Placebo matching selexipag 200 μg tablets to be administered orally twice daily
16086602|NCT02260544|Drug|Doxorubicin Hydrochloride Liposome Injection|50mg/m2, IV on Day 1 of each cycle, On Day 1 of Cycle 2 , patients will crossover to the alternate reference or test formulation , After completion of Cycle 2 ( Day 28) , patients will be continued on the treatment of Doxorubicin Hydrochloride Liposome injection upto 4 more cycles if tolerance permits under guidance of their attending physicians.
16086603|NCT02260531|Drug|Cabozantinib|
16086604|NCT02260531|Drug|Trastuzumab|
16086605|NCT02260518|Behavioral|Lifestyle Intervention|During pregnancy, participants complete one face-to-face counseling session, receive 10 behavioral podcasts, and receive weekly phone calls until delivery. Participants will be asked to attend one group session on breastfeeding. Participants will have the opportunity to participate in a private Facebook group during pregnancy and postpartum. During postpartum, participants complete one face-to-face counseling session, receive 16 behavioral podcasts, receive brief weekly check-in telephone calls for six weeks, and receive up to 8 telephone counseling calls through 6 months after delivery.
16086606|NCT02260518|Behavioral|Standard Care|Women will receive standard nutrition counseling provided by physicians, nurses, nutritionists, and counselors from the Women, Infants, and Children (WIC) program (if applicable). They will receive a monthly study mailing that is educational in nature as well as podcasts related to a healthy pregnancy. During pregnancy, the mailings will focus on tips for a healthy pregnancy and on fetal development. During postpartum the mailings will focus on infant development and parenting. We will select a matched number of podcasts from Pea in the Podcast, commercially available podcasts. All mailings and podcasts will avoid discussion of weight, PA, or diet (except for foods to avoid in pregnancy for safety reasons).
16086607|NCT02260505|Drug|Imatinib maintenance|Either 300 or 400 mg/day in accordance with the last dose routinely taken by the patient in the 3-year period before randomization. The treatment will be orally taken at time of meal with a large glass of water
16086608|NCT02260492|Drug|OT329 (combination of fluticasone propionate and salmeterol xinafoate)|Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler
16086609|NCT02260492|Drug|Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate)|Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler
16086610|NCT02260492|Drug|Placebo|Placebo (lactose) administered via the Solis dry powder inhaler
16086611|NCT02260479|Procedure|Preheated|Skin disinfection solution is preheated in a warming cupboard
16086612|NCT02260466|Other|a basal LV septum biopsy|During surgery, a basal LV septum biopsy will be collected for determination and quantification of interstitial deposits using specific staining which will be performed in a blind fashion
16086613|NCT02260453|Other|Preoperative coronary angiography|If coronary disease is detected percutaneous intervention (PCI) or coronary artery bypass grafting (CABG) is applied
16086614|NCT02260453|Other|Standard cardiac workup|EKG, transthoracic cardiac echocardiogram
16086615|NCT02260440|Drug|Pembrolizumab|Pembrolizumab will be given at 200 mg every 21 days
16086616|NCT02260440|Drug|Azacitidine|Azacitidine will be given at 100 mg daily subcutaneous injection on days 1-5 every 21 days.
16086617|NCT02260427|Device|Insertion of the i-gel|After induction of general anesthesia, the i-gel will be inserted according to randomly allocated group.
16086618|NCT02260427|Device|Insertion of the air-Q sp|
16086619|NCT02260414|Drug|Tinzaparin|single subcutaneous injection of 4500 IU tinzaparin
16086620|NCT02260414|Other|Blood sample|blood sample taken at hours 0, 3, 8, 18 and 24 after subcutaneous injection of 4500 IU tinzaparin
16086621|NCT02260401|Other|Individualized report|Each patient will receive an individualized report that contains their own outcome data for the first years of the LESS trial (including pain and function following treatment with epidural injections)
16086622|NCT02260388|Drug|Nortriptyline|
16086623|NCT02260388|Drug|Duloxetine|
16086624|NCT02260388|Drug|Pregabalin|
16086625|NCT02260388|Drug|Mexiletine|
16086626|NCT02260375|Biological|Mesenchymal Stromal Cells|
16086627|NCT02260349|Drug|indocyanine green infusion|intravenous injection (0,25mg/kg) of the indocyanine green 24h before prostatic surgery.
16086628|NCT02260336|Dietary Supplement|Panax Notoginseng Powder 1g|
16086629|NCT02260336|Dietary Supplement|Panax Notoginseng Powder 5g|
16086630|NCT02260336|Dietary Supplement|Panax Notoginseng Powder 10g|
16086631|NCT02260336|Dietary Supplement|Panax Notoginseng Powder 15g|
16086632|NCT02260336|Drug|Celecoxib Capsule 400 mg daily|
16086633|NCT02260323|Other|patient-tailored anti-arthritis herbs|patient use tailored anti-arthritis herbs
16086634|NCT02260323|Other|patient-tailored DMARDs|patient use tailored disease-modifying antirheumatic drugs
16086635|NCT02260310|Other|Weizhong and Huantiao|
16086636|NCT02260310|Other|A-shi point|
16086637|NCT02260297|Device|Wrist Actigraphy(motion sensors)with light sensors-Jawbone Up 2|
16086638|NCT02260284|Other|Yaotong points acupuncture|Patients receive the treatments of Yaotong points penetration
16086639|NCT02260284|Other|the usual care|participants received no study-related care-just the care, if any, that they and their physicians chose: mostly massage and physical therapy visits and continued use of medications (mostly nonsteroidal anti-inflammatory drugs (NSAIDS))
16086640|NCT02260284|Other|standardized acupuncture|Patients were given to the standardized acupuncture groups. This prescription included six acupuncture points that are commonly applied for the treatment of CLBP (Bladder 23-bilateral, Bladder 40-bilateral, and Kidney 3-bilateral) on the low back and lower leg.
16086641|NCT02260271|Other|Database Entry/Biospecimen Collection|blood, urine, buccal samples and medical data collected
16086642|NCT02260258|Drug|Rocuronium|Neuromuscular Blockade
16086643|NCT02260258|Drug|Normal Saline|Normal Saline
16086644|NCT02260245|Behavioral|Team training using the TeamSTEPPS model|Two or three master trainers from each affiliate will be undergo train-the-trainer training to bring back to their affiliate.
16086645|NCT02260232|Other|exercise training|
16086646|NCT02260219|Procedure|Surgical Implant of Ahmed Glaucoma Drainage Device, model M4 and S2|Surgically Implant an Ahmed Glaucoma Drainage Device Models S2 and M4, evaluare IOP evolution, complications and need for medication to control IOP
16086647|NCT02260206|Drug|Colchicine|Impact of Colchicine therapy on arrhythmia Recurrence after Acute Pericardial Effusion following Catheter Ablation of Atrial Fibrillation
16086648|NCT02260193|Drug|AKB-6548|Starting dose 1. Oral dose administered once daily for 16 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
16086649|NCT02260193|Drug|AKB-6548|Starting dose 2. Oral dose administered once daily for 16 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
16086650|NCT02260193|Drug|AKB-6548|Starting dose 3. Oral dose administered three times weekly for 16 weeks. Dose adjustment based on hemoglobin levels as defined in the protocol.
16086651|NCT02260180|Drug|A-101|Topical Solution
16086652|NCT02260167|Other|A mix of natural treatments and medications|
16086653|NCT02260154|Drug|Mebeverine|Subjects treated by Duspatalin (mebeverine) 200 mg BID (bis in die = twice a day) upto 6 weeks in accordance with routine practice will be observed
16086654|NCT02260141|Dietary Supplement|d-ribose|giving ribose in those with a diagnosis of Alzheimer's and/or dementia
16086655|NCT02260128|Other|Chewing gum|The intervention group will receive chewing gum four times daily following surgery.
16086656|NCT02260115|Device|LABS™|hydrogel sprayed laparoscopically over all pelvic areas of surgical trauma
16086657|NCT02260115|Procedure|Surgical Control|Surgery only
16086658|NCT02260102|Drug|Temocillin|Venous blood will be drawn (as per the protocol) for assay of temocillin on day 1 and day 4 of treatment. This is not part of our standard of care and is, therefore, an intervention. Patients are enrolled only if receiving temocillin as part of their normal standard of care (and the drug will be administered based on current recommendations [no change due to enrollment in the study]).
16086659|NCT02260089|Drug|Low dose of telmisartan|
16086660|NCT02260089|Drug|High dose of telmisartan|
16086661|NCT02260089|Drug|Placebo|
16086662|NCT02260076|Drug|PEG 400|
16086663|NCT02260076|Drug|Placebo|
16086664|NCT02260063|Drug|Epinastine syrup|
16086665|NCT02260063|Drug|Epinastine tablets|
16086666|NCT02260050|Drug|WAL 801 CL dry syrup new formulation|
16086667|NCT02260050|Drug|WAL 801 CL dry syrup conventional formulation|
16086668|NCT02260037|Drug|Epinastine nasal|
16086669|NCT02260037|Drug|Placebo|
16086670|NCT02260024|Other|High fat, high caloric meal|
16086671|NCT02260024|Drug|Pramipexole IR tablets|
16086672|NCT02260024|Drug|Pramipexole SR C|
16086673|NCT02260024|Drug|Pramipexole SR C2|
16086674|NCT02260024|Drug|Pramipexole SR C2A|
16086675|NCT02260024|Drug|Pramipexole SR C2B|
16086676|NCT02260011|Drug|Ipratropium bromide HFA-134a inhalation aerosol|
16086677|NCT02260011|Drug|Atrovent® CFC inhalation aerosol|
16086678|NCT02260011|Drug|Placebo|
16086679|NCT02259998|Drug|Persantin® new formulation|
16086680|NCT02259998|Drug|Persantin® commercial formulation|
16086681|NCT02259985|Drug|Itasetron tablet|
16086682|NCT02259985|Drug|Itasetron infusion|
16086683|NCT02259985|Other|high fat breakfast|
16086684|NCT02259972|Drug|BI 113823 solution|
16086685|NCT02259972|Drug|BI 113823 tablet|
16086686|NCT02259972|Drug|Placebo|
16086687|NCT02259972|Other|High fat, high calorie breakfast|only for dose group 5
16086688|NCT02259959|Drug|Single rising doses of BI 1744 CL, solution for oral inhalation|
16086689|NCT02259959|Drug|Tiotropium, fixed dose, solution for oral inhalation|
16086690|NCT02259959|Drug|Placebo|
16086691|NCT02259946|Drug|BI 1744 CL|
16086692|NCT02259946|Drug|Placebo|
16086693|NCT02259946|Drug|Tiotropium bromide|
16086694|NCT02259933|Drug|KUC 7483 CL|
16086695|NCT02259933|Drug|Placebo|
16086696|NCT02259920|Drug|KUC 7483 CL, immediate release tablet|
16086697|NCT02259920|Drug|KUC 7483 CL, particulate formulation|
16086698|NCT02259920|Drug|KUC 7483 CL, solution formulation|
16086699|NCT02259920|Device|Enterion™ capsule|
16086700|NCT02259907|Drug|KUC 7483 CL|
16086701|NCT02259907|Drug|Placebo|
16086702|NCT02259907|Other|High fat meal|
16086703|NCT02259894|Drug|BIRT 2584 XX|
16086704|NCT02259894|Drug|Placebo|
16086705|NCT02259881|Drug|Low dose of BIBT 986 CL, per i.v. infusion|
16086706|NCT02259881|Drug|Medium dose of BIBT 986 CL, per i.v. infusion|
16086707|NCT02259881|Drug|High dose of BIBT 986 CL, per i.v. infusion|
16086708|NCT02259881|Drug|Placebo|
16086709|NCT02259881|Drug|Lipopolysaccharide (LPS), single i.v. bolus|Endotoxin derived from E. coli bacteria, used for activation of coagulation
16086710|NCT02259868|Drug|BILR 355 BS /1B, current low dose formulation|
16086711|NCT02259868|Drug|BILR 355 BS /1B, current high dose formulation|
16086712|NCT02259868|Drug|BILR 355 BS - Jet Milled (JM) + Sodium Dodecyl Sulfate (SDS) formulation|
16086713|NCT02259868|Drug|BILR 355 BS - Hammer Milled (HM) + Sodium Dodecyl Sulfate (SDS) formulation|
16086714|NCT02259868|Drug|BILR 355 BS - Suspension low dose|
16086715|NCT02259868|Drug|BILR 355 BS - Suspension high dose|
16086716|NCT02259868|Drug|Ritonavir|
16086717|NCT02259855|Drug|Tipranavir|
16086718|NCT02259855|Drug|Ritonavir|
16086719|NCT02259855|Drug|Pegylated interferon|
16086720|NCT02259855|Drug|Ribavirin|
16086721|NCT02259842|Drug|BI 34021 FU2 solution|
16086722|NCT02259842|Drug|BI 34021 FU2 tablet|dose group 4 only
16086723|NCT02259842|Drug|Placebo|
16086724|NCT02259842|Other|High fat, high calorie breakfast|only for dose groups 3 and 5
16086725|NCT02259829|Drug|Telmisartan/Amlodipine|Fixed dose combination tablet
16086726|NCT02259829|Drug|Telmisartan|
16086727|NCT02259829|Drug|Amlodipine|
16086728|NCT02259816|Drug|Telmisartan|
16086729|NCT02259816|Drug|Amlodipine|
16086730|NCT02259803|Drug|Telmisartan/amlodipine fixed-dose combination (FDC) tablet|
16086733|NCT02259790|Drug|Telmisartan/amlodipine fixed-dose combination tablet|
16086734|NCT02259790|Drug|Telmisartan|
16086735|NCT02259790|Drug|Amlodipine|
16086736|NCT02259777|Drug|Telmisartan/Amlodipine|Fixed dose combination tablet
16086737|NCT02259777|Other|high fat, high caloric meal|
16086738|NCT02259764|Drug|KUC 7483 CL - single rising dose|
16086739|NCT02259764|Drug|Placebo|
16086740|NCT02259764|Other|standardized high fat meal|
16086741|NCT02259751|Drug|KUC 7483 CL|
16086742|NCT02259751|Drug|Placebo|
16086743|NCT02259738|Drug|Human Urinary Kallidinogenase|
16086744|NCT02259738|Drug|Shuxuening injection|
16086745|NCT02259725|Drug|regorafenib|Given PO
16086746|NCT02259725|Other|laboratory biomarker analysis|Correlative studies
16086747|NCT02259712|Other|Hipopressive exercises|45 minutes treatment by hipopressive exercises 2 times per week during 8 weeks. They will be doing in different positions: standing, kneeling, sitting and lying. The patient will be teach a total of 30 exercises. In the week number 8 the women with the physical therapist will choose 3 exercises that will be done daily at home during 20 minutes.
16086748|NCT02259712|Behavioral|Therapeutic education.|"The therapeutic education will be doing during the 8 weeks of treatment. In the first day the knowledge and the briefs of the pelvic floor dysfunction will be assessed. Dietary and behavioral habits will also be discussed. In the second day anatomical and physiological explanation of the pelvic girdle will be the priority. In the third day will be explained the signs and symptoms of the different pelvic floor dysfunctions. In the four day will be analyzed the risk factors that may cause or worsen pelvic floor dysfunctions.
~In the fifth day will be begun to correct the bad habits. In the last day will be reviewed the knowledge and new habits acquired during the treatment. In all treatment days will be discussed the doubts of the participant."
16086749|NCT02259712|Other|Pelviperineal physiotherapy|45 minutes physical therapy treatment 2 times per week during 8 weeks. There will be done specific exercises of the pelvic floor muscles and coordination exercises of the pelvic floor muscles with other muscles in different positions. Electrostimulation, biofeedbak, cones and dinamometric devices can be employed to improve the muscle performance.
16086750|NCT02259712|Other|Physical Therapy assessment|Pre-treatment, post-treatment, 3, 6 and 12 months after physical therapy treatment. Will be done a specific evaluation of pelvic floor muscles using the Modified Oxford Scale, superficial electromyography, perineometry and dynamometer. For the evaluation of the impact, the signs and the symptoms questionnaires will be completed by the participants.
16086751|NCT02259699|Other|Decision Aid|PCOA will be designed to accomplish 2 objectives: 1) it will educate patients and allow them to assimilate information about the differences in outcomes and survival between IP and IV therapies; and 2) it will help patients make the difficult trade-offs between these two treatment options.
16086752|NCT02259686|Drug|Apelin 1mg subcutaneous|single subcutaneous injection of Apelin 1mg subcutaneous
16086753|NCT02259686|Drug|Apelin 1mg intravenous|15 minute intravenous bolus of Apelin 1mg intravenous
16086754|NCT02259686|Drug|Apelin 5mg subcutaneous|single subcutaneous injection of Apelin 5mg subcutaneous
16086755|NCT02259686|Drug|Apelin 5mg intravenous|15 minute intravenous infusion of Apelin 5mg intravenous
16086756|NCT02259686|Drug|Apelin 10 mg subcutaneous|24 hour continuous subcutaneous infusion of Apelin 10 mg subcutaneous
16086757|NCT02259673|Other|Fun exercise|Intervention group 3 times a week for 20 minutes during 2 months, fun physical exercises (including activities carried out with the use of sports equipment such as beach ball, stretch, bird toys, etc)
16086758|NCT02259673|Other|fun exercise|"Intervention group 3 times a week for 20 minutes during 2 months, fun physical exercises
~(including activities carried out with the use of sports equipment such as beach ball, stretch, bird toys, etc)"
16086759|NCT02259660|Device|Respiratory muscle strength training|Inspiratory and expiratory muscle strength training occur when subjects are required to breath in (as with inspiratory training) or out (as with expiratory training) through a pressure threshold device. This device features a spring-loaded one way valve which will only open if the subject is able to generate sufficient air pressure to overcome a predetermined pressure threshold. This threshold is typically set at 75% of the subject's maximum capacity. Repeatedly overcoming this threshold during training produces a strengthening effect in most people.
16086760|NCT02259660|Device|Sham respiratory muscle strength training|The placebo / sham intervention will mimic the active intervention(s) in every respect except the devices used will be rendered neutral via removal of the pressure threshold spring inside the devices.
16086761|NCT02259647|Drug|Sorafenib 400mg twice daily + intravenous infusion ofVit K1|Sorafenib 400mg twice daily + intravenous infusion ofVit K1 50 mg/day with daily increase of dose by 50 mg for 6 days, followed by oral Vitamin K1 20mg twice daily for 3month
16086762|NCT02259647|Drug|Sorafenib 400 mg twice daily + Intravenousinfusion of placebo|Sorafenib 400 mg twice daily + Intravenousinfusion ofplacebo daily for 6 days, followed by oral placebo twice daily x 3month
16086763|NCT02259634|Behavioral|Patient Navigation|Motivational Interviewing
16086764|NCT02259621|Drug|Nivolumab|Anti-PD-1 Therapy
16086765|NCT02259621|Drug|Carboplatin|Anti-PD-1 Therapy
16086766|NCT02259621|Drug|Paclitaxel|Anti-PD-1 Therapy
16086767|NCT02259608|Biological|BCG vaccine SSI|BCG vaccination
16086768|NCT02259595|Drug|HPN-07|500-1,500 mg oral capsules administered in a single dose
16086769|NCT02259595|Drug|NAC|1,200mg NAC administered via oral capsule in single dose
16086770|NCT02259595|Drug|Placebo|placebo oral capsule
16086771|NCT02259582|Drug|Pemetrexed|
16086772|NCT02259582|Drug|Carboplatin|
16086773|NCT02259582|Drug|demcizumab|
16086774|NCT02259569|Other|Pressure-controlled ventilation|
16086775|NCT02259569|Other|Volume-controlled ventilation|
16086776|NCT02259556|Biological|CART30|Cells will be infused 1 day after the completion of conditioning regimen.
16086777|NCT02259543|Other|Root conditioning with citric acid+tetracycline solution|Application of a citric acid + tetracycline gel solution (1:1) for decontamination of root surfaces during the treatment of recession defects by subepithelial connective tissue graft
16086778|NCT02259530|Behavioral|Integrated Psychotherapeutic Intervention|Evidence-based standard tools for the treatment of PTSD and comorbid khat dependence: Community Reinforcement Approach, Relapse Prevention, Narrative Exposure Therapy
16086779|NCT02259517|Drug|Guanfacine|Participants will meet with the study doctor on a weekly basis during the treatment phase of the study. In the first few weeks, the daily dose of the medication will be individually adjusted by the study doctor according to participants' clinical response to and tolerability of the medication. The optimal dose will then be maintained for the remainder of the treatment period.
16086780|NCT02259517|Drug|Lisdexamfetamine|Participants will meet with the study doctor on a weekly basis during the treatment phase of the study. In the first few weeks, the daily dose of the medication will be individually adjusted by the study doctor according to participants' clinical response to and tolerability of the medication. The optimal dose will then be maintained for the remainder of the treatment period.
16086781|NCT02259504|Other|PHASE 1- HyperSoft® 3D and HyperSoft® Helical Coils|Framing with HyperSoft® 3D or any FDA-approved bare platinum coil. Must fill and finish the the aneurysm with HyperSoft® 3D and/or HyperSoft® helical coils.
16086782|NCT02259504|Other|PHASE 2 - HydroSoft® 3D and HydroSoft® Helical Coils|Framing with HydroFrame® or HydroSoft® 3D coils. Must fill the aneurysm with HydroFrame®, HydroSoft® (3D and/or Helical), and/or HydroFill® Coils and finish with HydroSoft® (3D and/or Helical) Coils.
16086783|NCT02259491|Other|Manuka Honey Dressing|After surgical resection and reconstruction the skin graft donor site (thigh) and the free flap donor site will be dressed with Medihoney surgical dressings. More specifically, a dressing of appropriate size will be applied to the anterior thigh and covered with tegaderm. For the STSG recipient site a Medihoney dressing will cover the skin graft, followed by dry gauze, kerlex and a cast.
16086784|NCT02259465|Behavioral|low FODMAP diet|Participants will attend a one-hour group session on how to follow the low FODMAP diet, run by a dietitian trained in the diet. They will be asked to follow the diet for 7 days while keeping a food diary.
16086785|NCT02259465|Dietary Supplement|Oligofructose|Participants will supplement their diet with 7 grams of OF twice daily for the week that they follow the low FODMAP diet.
16086786|NCT02259465|Dietary Supplement|Maltodextrin|Participants will supplement their diet with 7 grams of maltodextrin twice daily for the week that they follow the low FODMAP diet.
16086787|NCT02259452|Procedure|SPECT Lung Perfusion Scan|
16086788|NCT02259452|Procedure|SPECT Heart Perfusion Scan|
16086789|NCT02259452|Procedure|Pulmonary Function Tests|
16086790|NCT02259426|Drug|Dihydroartemisinin-piperaquine combination (Artekin)|
16086791|NCT02259426|Drug|Primaquine|Single-dose 0.25mg/kg
16086792|NCT02259413|Behavioral|Exercise Rehabilitation|This intervention will consist of lifestyle education, home-based resistance exercise and stationary cycling during hemodialysis sessions. Duration of the intervention will be 26 weeks.
16086793|NCT02259400|Device|NSIPPV|In N-SIPPV, the physician will set : an initial PEEP of 4-6 cmH20; a peak inspiratory pressure (PIP) of 15-20 cmH2O ; an inspiratory time (IT) of 0.3-0.4 seconds; a flow rate of 6-10 L/min and a respiratory rate (RR) of 40 bpm with the lowest FiO2 to maintain a oxygen saturation (SpO2) of 88-93%. Weaning from N-SIPPV will be performed with a reduction of the RR to 15 bpm with a PIP of 10-15 cmH2O and PEEP of 4 cmH2O and will be stopped when the baby will not show signs of RDS and with a fraction of inspired oxygen (FiO2)< 0.3.
16086794|NCT02259400|Device|BiPAP|In BiPAP, the physician will set : an initial low CPAP-level of 4-6 cmH20 and high CPAP-level of 8-9 cmH20; a time high of 1 second and a pressure exchange rate of 20 bpm, with the lowest FiO2 to maintain a SpO2 of 88-93%. Weaning will start with a progressive reduction of the set pressure exchange rate ( minimum 15 pressures exchange/min), followed by the reduction of the higher level-CPAP down to 6 cmH20 and lower level-CPAP down to 4 cmH20. BiPAP will be stopped when the baby will not show signs of RDS and with a FiO2 < 0.3.
16086795|NCT02259374|Procedure|TAP BLOCK 0.2% ROPIVACAINE|Patients randomised to this group will receive 20 ml 0.2% Ropivacaine for bilateral TAP block after hysterectomy
16086796|NCT02259374|Procedure|TAP BLOCK 0.4% ROPIVACAINE|Patients randomised to this group will receive 20 ml 0.4% Ropivacaine for bilateral TAP block after hysterectomy
16086797|NCT02259361|Drug|Sustained-release oral dalfampridine|One Sustained-release oral dalfampridine; 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening) taken for 14 consecutive days.
16086798|NCT02259361|Drug|Placebo|Placebo, 10 mg tablet, twice daily, taken 12 hours apart (one tablet in the morning and one tablet in the evening) taken for 14 consecutive days.
16086799|NCT02259348|Drug|Cyclophosphamide|Given intravenously (IV)
16086800|NCT02259348|Drug|Fludarabine|Given IV
16086801|NCT02259348|Biological|G-CSF|Given IV or subcutaneously (SQ)
16086802|NCT02259348|Biological|Interleukin-2|Given SQ
16086803|NCT02259348|Drug|Melphalan|Given IV
16086804|NCT02259348|Drug|Thiotepa|Given IV
16086805|NCT02259348|Drug|Rituximab|Given IV
16086806|NCT02259348|Biological|Natural killer cell therapy|Given IV
16086807|NCT02259348|Biological|T-cell depleted HPC transplant|T-cell depleted hematopoietic stem cells will be infused on day 0.
16086808|NCT02259348|Biological|CD45RA-depleted HPC transplant|CD45RA depleted stem cells will be infused on day 1.
16086809|NCT02259335|Device|Extracorporeal CO2 removal device|A device able to remove CO2 using a dedicated device connected to the patient via a double lumen catheter inserted in the femoral vein
16086810|NCT02259322|Behavioral|Standard-of-Care|Standard-of-Care with bariatric team. Participants will be encouraged to continue their care with their bariatric team.
16086811|NCT02259322|Behavioral|Behavioral Weight Loss Treatment|Biweekly individual guided self-help sessions for 3 months
16086812|NCT02259322|Behavioral|Cognitive Behavioral Therapy|Biweekly individual guided self-help sessions for 3 months
16086813|NCT02259309|Drug|Misoprostol - buccal|buccal administration
16086814|NCT02259309|Drug|Misoprostol - vaginal|vaginal administration
16086815|NCT02259296|Procedure|Lower eGFR for AVF construction|Lower eGFR patients (eGFR<10ml/min 1.73m2 for patients without diabetic kidney disease, and eGFR<15ml/min 1.73m2 for diabetic kidney disease) are proposed to undergo AVF construction
16086816|NCT02259296|Procedure|Higher eGFR for AVF construction|Higher eGFR patients (eGFR 10-15ml/min 1.73m2 for patients without diabetic kidney disease, and eGFR 15-20ml/min 1.73m2 for diabetic kidney disease) are proposed to undergo AVF construction
16086817|NCT02259283|Device|Hybrid Knife|POEM (Per oral endoscopic myotoymy) technique performed with the hybrid knife which combines injection and cutting in the same device.
16086818|NCT02259270|Other|Record review|Record review. No intervention with patient or physician. No effect on outcome.
16086819|NCT02259270|Other|AST-history|Checking history (period and number) of ambulatory dispensed AST from 1 year before till 1 year after hospitalisation. No intervention with patient or physician. No effect on outcome.
16086820|NCT02259244|Behavioral|Weight reduction program|
16086821|NCT02259231|Drug|Omaveloxolone Capsules (2.5 mg/capsule)|Capsules containing 2.5 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
16086822|NCT02259231|Drug|Ipilimumab (3 mg/kg)|Sterile solution containing ipilimumab to be delivered intravenously at 3mg/kg
16086823|NCT02259231|Drug|Nivolumab (240 mg)|Sterile solution containing nivolumab to be delivered intravenously at 240 mg
16086824|NCT02259231|Drug|Omaveloxolone Capsules (10 mg/capsule)|Capsules containing 10 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
16086825|NCT02259231|Drug|Omaveloxolone Capsules (50 mg/capsule)|Capsules containing 50 mg of omaveloxolone per capsule to the dosage indicated in the Arm Label
16086826|NCT02259218|Other|laboratory biomarker analysis|Correlative studies
16086827|NCT02259205|Other|Enriched Yogurt|150 g yogurt enriched with bioactive lipids extract from olive oil mill will be provided daily for 8 weeks
16086828|NCT02259205|Other|Plain Yogurt|150 g plain yogurt will be provided daily for 8 weeks
16086829|NCT02259192|Device|MED-EL Maestro Cochlear Implant|cochlear implant
16086830|NCT02259179|Drug|Reference naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets)|
16086831|NCT02259179|Drug|Test naltrexone 8 mg SR/bupropion 90 mg SR combination trilayer tablets (2 tablets)|
16086832|NCT02259166|Other|EHFP+|Enhanced-homestead food production program including home gardening and poultry rearing + WASH interventions + SBCC around the essential nutrition actions and WASH/malaria prevention with a gender component.
16086833|NCT02259153|Behavioral|Changes in cholesterol metabolism|
16086834|NCT02259153|Other|Lean red meat diet|
16086835|NCT02259153|Other|Fat red meat diet|
16086836|NCT02259140|Procedure|Proximal Femoral Resection Arthroplasty|Drains will be placed at the surgeon's discretion. Patients will be placed in skin traction on the operative side. Post-operative bracing or casting will be at the surgeon's discretion. All patients will receive standardized post-operative prophylactic radiation to minimize heterotopic ossification.
16086837|NCT02259140|Procedure|Subtrochanteric Valgus Osteotomy|Drains will be placed at the surgeon's discretion. Post-operative bracing or casting will be at the surgeon's discretion. All patients will receive standardized post-operative prophylactic radiation to minimize heterotopic ossification.
16086838|NCT02259127|Drug|DTG|
16086839|NCT02259114|Drug|Birabresib|Birabresib 10, 20 and/or 40 mg oral capsules
16086840|NCT02259101|Behavioral|CBT-I Treatment Condition|Each group will last approximately 1 hour and will involve completing surveys in order to track both the quantity and quality of sleep. Blood will be drawn twice in order to compare how the body responds to medical illnesses.
16086841|NCT02259101|Behavioral|SH Comparison Condition|Each group will last approximately 1 hour and will involve completing surveys in order to track both the quantity and quality of sleep. Blood will be drawn twice in order to compare how the body responds to medical illnesses.
16086842|NCT02259088|Drug|Ranibizumab (RFB002)|Ranibizumab 0.5 mg/0.05 mL for intravitreal injection
16086843|NCT02259088|Procedure|Laser|Laser photocoagulation according to Early Treatment Diabetic Retinopathy Study (ETDRS) guidelines
16086844|NCT02259088|Drug|Sham injection|Imitation of an intravitreal injection consisting of an empty vial and an injection syringe without a needle
16086845|NCT02259088|Procedure|Sham laser|Imitation of an active laser
16086846|NCT02259075|Drug|Botulinum Toxin Type A|
16086847|NCT02259062|Other|Music with brief mindfulness intervention|Music listening with mindfulness therapy
16086848|NCT02259062|Other|Music listening alone|
16086849|NCT02259062|Other|Audiobook listening|
16086850|NCT02259049|Dietary Supplement|L-tyrosine|Each subject will receive 2,000 mg of L-tyrosine BID for 24 hours.
16086851|NCT02259049|Dietary Supplement|Sugar Pill|Each subject will receive a sugar pill BID for 24 hours.
16086852|NCT02259036|Other|Ecological Momentary Treatment Enhancement|Participants will be given a pre-programmed smartphone on which they will enter their responses to a series of questions about moods and daily experiences using an app developed for this study. The child will receive an electronic notification message once per day and will be prompted through a series of questions about what he/she is doing, who he/she is with, how he/she is feeling, worries or stressful events, and how he/she coped with these events. It should take the child approximately 5 minutes each time to complete the questions. Participant data will be sent to study therapists to be reviewed weekly. The therapist will integrate this information into treatment and provide customized feedback to the patient.
16086853|NCT02259023|Other|Liquid: Sugar sweetened beverage consumption|Sugar sweetened beverage consumption
16086854|NCT02259023|Other|Solid: Grain based desserts and candy consumption|Grain based desserts and candy consumption
16086855|NCT02259010|Drug|Alisertib|Alisertib tablets
16086856|NCT02259010|Drug|Itraconazole|Itraconazole oral solution
16086857|NCT02258984|Device|Mespere Venus 1000 Non-Invasive CVP System|The Venus 1000 CVP System is a non-invasive central venous pressure measurement system that utilizes the proven science of NIRS. Approved by FDA, received Health Canada Medical Device Licence and CE Marked, the Venus 1000 has been proven to be clinically equivalent to measurements made via right heart catheterization.
16086858|NCT02258971|Drug|BEA 2180 BR oral|Oral solution
16086859|NCT02258971|Drug|BEA 2180 BR infusion|Solution for infusion to be reconstituted with isotonic saline
16086860|NCT02258919|Procedure|Decompressive craniectomy (DC) and best medical treatment|"Decompressive craniectomy:
~All patients in the treatment group will receive DC of at least 12 cm according to institutional guidelines and a published surgical protocol.
~Best medical treatment:
~Best medical treatment is based on American Heart Association/American Stroke Association (AHA/ASA) and European Stroke Organisation (ESO) as published in the current protocol from 2010 and 2014 respectively."
16086861|NCT02258919|Procedure|Best medical treatment|Best medical treatment is based on American Heart Association/American Stroke Association (AHA/ASA) and European Stroke Organisation (ESO) as published in the current protocol from 2010 and 2014 respectively.
16086864|NCT02258893|Other|NO2 Scrubber|an NO2 scrubber that removes NO2 and particles
16086865|NCT02258893|Other|HEPA filter|a HEPA filter that removes 95% of suspended particles ≥ 0.003 μm in size (but does not remove NO2)
16086866|NCT02258893|Other|Control|"a control filter designed to be the same size and weight as the other two filters, but filters neither NO2 nor particles"
16086867|NCT02258880|Drug|SUN13837|
16086868|NCT02258880|Drug|placebo|
16086869|NCT02258867|Drug|Placebo|Solution for subcutaneous injection
16086870|NCT02258867|Drug|Gevokizumab|Solution for subcutaneous injection
16086871|NCT02258854|Drug|Dose 2 gevokizumab|Solution for subcutaneous injection
16086872|NCT02258841|Behavioral|Setting Priorities for Safety|Participants rate the importance of 5 priorities to decision-making about their unsafe relationship by comparing the relative importance of each pair of priorities. Weights for each priority are computed and provided to the woman, along with examples of safety strategies that fit with her top ranked priority.
16086873|NCT02258841|Behavioral|Danger Assessment|Participants complete a calendar to show episodes of physical and/or sexual violence they have experienced in the past 12, along with 20 questions assessing risk of serious or lethal violence. A standardized weighted score is provided, along with a brief explanation about her level of danger and appropriate actions she may take.
16086874|NCT02258841|Behavioral|Personalized Action Plan|Women create a tailored action plan for themselves by selecting strategies from 8 different groups, including those which are recommended to them based on their responses to previous questions.
16086875|NCT02258841|Behavioral|General risk and safety information|Participants receive general information about the importance of priorities in making safety decisions and risk factors for intimate partner violence.
16086876|NCT02258841|Behavioral|Basic Emergency Safety Plan|Participants are provided with a basic emergency plan including information about local DV resources. The information is not personalized but is consistent with online information which women could find on their own (usual care)
16086877|NCT02258828|Drug|Memantine|Subjects initially received memantine 5 mg once daily, which was increased weekly by 5 mg/day in divided doses to a dose of 20 mg/day
16086878|NCT02258828|Drug|Placebo|Matched placebo
16086879|NCT02258815|Drug|ch14.18/CHO|"A six courses regimen consisting of a 8 hour infusion (ch14.18/CHOmAb 20 mg/m² ) for five consecutive days will be administered every 4 weeks.
~Interleukin 2 will be added to cycles 4-6 at days 6,8,10 (1 x 106 IU/m²/d s.c.) Participants will be premedicated with an intravenous antihistamine and ranitidine within approximately 30 minutes prior and during the infusion of the study agent Pain as an anticipated side effect is managed by a standard pain prophylaxis with Morphium hydrochloride Disease status will be evaluated after 3 and 6 courses and after 1 year."
16086880|NCT02258802|Behavioral|Psychoeducational intervention|A mobile kitchen visits the 5 selected communities every 2 weeks for a period of 1 year. A 30 minute cooking lesson is given by a trained instructor, the recipes have been designed to be quick and easy to make, use local and inexpensive ingredients, contain mostly vegetables and have a good taste. During the lesson, healthy habit and cooking tips are mentioned. A printed version of the recipe is given to every participant. Every lesson a different participant is encouraged to help prepare the recipe. At the end of the lesson all the participants get to taste the meal and express their opinion.
16086881|NCT02258789|Other|VR-method|Neglect rehabilitation by intense scanning training and multi sensory stimuli using Virtual Reality
16086882|NCT02258776|Dietary Supplement|Pomegranate Extract|Pomegranate extract 1000mg will be taken 1/day for 12 weeks.
16086883|NCT02258776|Dietary Supplement|Pomegranate Juice|Pomegranate juice 8oz will be consumed 1/day for 12 weeks.
16086884|NCT02258776|Dietary Supplement|Placebo|Placebo will be taken 1/day for 12 weeks.
16086885|NCT02258763|Drug|Amoxicillin-Potassium Clavulanate Combination|Oral antibiotic for 10 days
16086886|NCT02258763|Drug|Placebo|Placebo made to look like the study drug-main ingredient sugar syrup made by the pharmacy department in the hospital In the placebo arm, patient will be given 3 days of antibiotic followed by 7 days of placebo
16086887|NCT02258750|Dietary Supplement|Polydextrose|High fibre polydextrose enriched tomato soup (matched for sensory and nutritional characteristics to control) and eaten one hour before an ad-libitum lunch on study days. A 410g pre-packaged portion will be provided which contains 6% polydextrose compared to control.
16086888|NCT02258750|Other|Control|Tomato soup (matched for sensory and nutritional characteristics to control) served in a 410g portion and eaten one hour before an ad-libitum lunch on study days.
16086889|NCT02258737|Behavioral|Transitional Case Management|The case management activity deals with organizational and clinical aspects. The objective is to focus on network's expectations during hospitalization and at discharge, and ensure contacts between hospital and patient' social network. The aim is to support patient during the transition phase following discharge
16086890|NCT02258737|Behavioral|Standard Care|Routine hospitalization care is broadly defined as the usual level of care in the context of the adult department of psychiatry of the CHUV (Centre Hospitalier Universitaire Vaudois).
16086891|NCT02258711|Device|SIMPLE 2.0|SIMPLE 2.0 psychoeducative and self-monitoring smart-phone application plus treatment as usual.
16086892|NCT02258698|Procedure|Cardiac surgery|Blood samples for assessing Insulin resistance by HOMA, QUICKI, HbA1c, ANGPTL2, CXCL5, visfatin and irisin are drawn during induction of anesthesia, upon arrival on the intensive care unit and on postoperative day 1 and 3. Thirty days after surgery adverse outcomes covering all-cause morbidity and mortality will be assessed.
16086893|NCT02258672|Other|Prehabilitation program|Progressive and individualized physical training aimed at improving core muscles strength and endurance as well as spinal stability.
16086894|NCT02258659|Drug|paclitaxel albumin-stabilized nanoparticle formulation|Given IV
16086895|NCT02258659|Drug|carboplatin|Given IV
16086896|NCT02258659|Radiation|radiation therapy|Undergo radiation therapy
16086897|NCT02258659|Drug|paclitaxel|Given IV
16086898|NCT02258659|Drug|fluorouracil|Given IV
16086899|NCT02258659|Drug|hydroxyurea|Given PO
16086900|NCT02258659|Drug|cisplatin|Given IV
16086901|NCT02258659|Other|laboratory biomarker analysis|Correlative studies
16086902|NCT02258659|Procedure|quality-of-life assessment|Ancillary studies
16086903|NCT02258646|Behavioral|Exercise training at home|
16086904|NCT02258646|Behavioral|Telemonitoring and education/self-management|
16086905|NCT02258633|Other|Interactive interview and tailored family centered seatbelt safety intervention|
16086906|NCT02258620|Drug|dinitrate isosorbide|dinitrate isosorbide (cedocard*) by continuous intra venous (1 to 5 mg/h) dinitrate isosorbide (cedocard*) 5 mg by intra arterial direct in the sheat
16086907|NCT02258620|Drug|nitroglycerine|nitroglycerine dermal patch 15 mg/24h : 67,2 mg/21 cm2
16086908|NCT02258607|Drug|Momelotinib (MMB)|Momelotinib (MMB) tablet(s) administered orally once or twice daily
16086909|NCT02258607|Drug|Trametinib|Trametinib tablet administered orally once daily
16086910|NCT02258594|Other|Web-Based Patient Centered Toolkit (PCTK)|"The PCTK provides patients/care partners tailored health information regarding conditions, test results, and medications presented at a consumer health literacy level, and the ability to communicate with care team members via patient-facing tools accessible from bedside tablet computers. The PCTK allows patients to post questions to their care team members via a patient-centered microblog. The microblog facilitates development of a collaborative patient plan of care. The provider-facing PCTK includes tools that engage care team members in 1) completing a safety checklist and viewing a safety dashboard; 2) viewing patient-inputted information (goals, preferences, concerns) regarding the plan of care; 3) identifying clinical problems, care team goals, and patient schedules for education and multidisciplinary communication; 4) messaging patients on the patient thread; and 5) discussing patient's plan of care with other providers via the provider thread."
16086911|NCT02258594|Behavioral|The Patient-SatisfActive® Model|The Patient-SatisfActive Model is a structured, pro-active, patient-centered care model that aims at improving patient satisfaction by enhancing the degree to which patients' needs, concerns and expectations are met and by preserving dignity and respect. The model comprises steps that enhance interpersonal communication between clinicians and patients, incorporates clinicians' efforts to ascertain, address and document patients' needs, concerns, expectations and perceptions throughout hospitalization, and includes elements that empower and engage patients in their care.
16086912|NCT02258581|Drug|GS-4774|Exposure of interest for participants who received GS-4774 (administered as a subcutaneous injection) in a previous Gilead study for chronic hepatitis B virus infection.
16086913|NCT02258581|Drug|GS-9620|Exposure of interest for participants who received GS-9620 (tablets administered orally) in a previous Gilead study for chronic hepatitis B virus infection.
16086914|NCT02258581|Drug|Tenofovir disoproxil fumarate (TDF)|Exposure of interest for participants who received TDF (tablets administered orally) in a previous Gilead study for chronic hepatitis B virus infection.
16086915|NCT02258568|Behavioral|Smoking abstinence counseling|Telephone smoking abstinence counseling based on motivational interviewing concepts
16086916|NCT02258555|Drug|GS-9901|GS-9901 tablets administered orally
16086917|NCT02258542|Biological|Benralizumab|Benralizumab administered subcutaneously
16086918|NCT02258542|Biological|Benralizumab|Benralizumab administered subcutaneously
16086919|NCT02258529|Drug|Idelalisib|150 tablets administered orally twice daily
16086920|NCT02258529|Biological|Rituximab|375 mg/m^2 administered intravenously (weekly for 4 weeks and then every 8 weeks from Week 12 up to Week 100)
16086921|NCT02258516|Behavioral|CHIME 3-M|behavioral intervention for self-management in heart failure
16086922|NCT02258516|Behavioral|attention control|patients will receive phone calls regarding health-related topics not associated with heart failure
16086923|NCT02258503|Other|pain in elderly patients|
16086924|NCT02258490|Biological|G-CSF mobilized CD34+ selected cells for transplantation|After screening and enrollment, donor will receive mobilization therapy with G-CSF (10 ug/Kg S/C daily x5-6 days) using standard National Marrow Donor Program guidelines. CD34+ cell selection will be performed according to procedures given in CliniMACS Operating Manual and institutional Standard Operating Procedures. If storage after CD34+ selection is necessary, product will be kept in a monitored refrigerator. During storage, leukocyte concentration should not exceed 2 x 108 cells/ml using platelet poor plasma to adjust cell concentration. If donor's plasma is not available, CliniMACS buffer will be used. Cell processing will be performed by personnel trained by Miltenyi on CliniMACS system prior to initiation of clinical product selection. After tests are performed and product passes release criteria, patient will receive final product. No conditioning regimen will be administered prior to cell infusion.
16086925|NCT02258477|Dietary Supplement|Sequence 1|100 calorie beverage during week 1; 10 calorie beverage during week 2; control beverage beverage during week 3; 50 calorie beverage during week 4.
16086926|NCT02258477|Dietary Supplement|Sequence 2|Control beverage during week 1; 100 calorie beverage during week 2; 50 calorie beverage during week 3; 10 calorie beverage during week 4.
16086927|NCT02258477|Dietary Supplement|Sequence 3|50 calorie beverage during week 1; control beverage during week 2; 10 calorie beverage during week 3; 100 calorie beverage during week 4.
16086928|NCT02258477|Dietary Supplement|Sequence 4|10 calorie beverage during week 1; 50 calorie beverage during week 2; 100 calorie beverage during week 3; control beverage during week 4.
16086929|NCT02258464|Drug|Radium-223 dichloride (Xofigo, BAY88-8223)|Up to 6 cycles of radium-223 dichloride 50kBq/kg body (55 kBq/kg after implementation of National Institute of Standards and Technology [NIST] update)
16086930|NCT02258464|Drug|Placebo (saline)|Up to 6 cycles of saline injection
16086931|NCT02258464|Other|Background hormonal therapy|Prescribed by PI and was provided as long as patient can tolerate treatment. It must be prescribed as per local label in country participating.
16086936|NCT02258438|Behavioral|Uninterrupted sitting|Subjects will be asked to refrain for two days from any structured activity and to reduce any daily life activity (walking, taking the stairs, biking, etc.) in their daily life. On day 3, subjects will remain seated all day in the room calorimeter, except to rise from the chair to void.
16086983|NCT02258074|Drug|Placebo (for Nicotinamide)|Sugar pill manufactured to mimic Nicotinamide 750 mg capsule
16086937|NCT02258438|Behavioral|Sitting + 1 bout of activity|Subjects will be asked to perform 45 minutes of moderate-exercise in the morning once per day for two days in their daily life. On day 3 they will remain seated all day in the room calorimeter, except to rise from the chair to void, and to perform one bout of 45-min moderate-intensity (defined below) walking on a treadmill at 1000.
16086938|NCT02258438|Behavioral|Sitting + microbursts of activity|Subjects will be asked to refrain from any structured exercise for two days but to walk for 5 minutes each hour between 1000 and 1800 in daily life. On day 3, subjects will rise from the seated position every hour for 9 hours from 1000 to 1800 to complete 5min moderate-intensity (defined below) walking on a treadmill, which represents a total of 45min.
16086939|NCT02258425|Behavioral|FEM-CARE|
16086940|NCT02258425|Behavioral|Health Promotion|
16086941|NCT02258412|Drug|hand antiseptic with CHG and alcohol|HCWs will be randomized to use one product on one day and the other product on another day at least 3 days apart. Each product will be applied using 1 pump from its dispenser and rubbed over the hands until dry. Gloves will be worn while the HCW is in the patient room. Upon exit from the room, HCW will washoout with that same product. One imprint will be made of the non-dominant hand onto media containing neutralizers. That hand will be gloved with a white cotton glove. The HCW will work in the common areas with timing recorded. Upon leaving the common area, the dominant ungloved hand will be imprinted onto a fresh media plate containing neutralizers.
16086942|NCT02258412|Drug|Alcohol hand sanitizer foam|Alcohol foam hand sanitizer applied with 1 pump into hands, spread over hands up to the wrist and rubbed until dry. Foam will be applied twice approximately 15-30 minutes apart on one day
16086943|NCT02258399|Behavioral|Exercise|Moderate intensity exercise
16086944|NCT02258399|Dietary Supplement|Breakfast|Breakfast consumption
16086945|NCT02258373|Device|CGM+BGM|Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm + Abbot Precision Xtra Blood Glucose-Ketone Meter
16086946|NCT02258373|Device|CGM Only|Dexcom G4 Platinum Continuous Glucose Monitoring System with modified algorithm
16086947|NCT02258360|Other|Therapeutic hypothermia|Therapeutic hypothermia with a target temperature between 32-34°C.
16086948|NCT02258347|Device|Echopulse|
16086949|NCT02258334|Biological|Fluzone® Quadrivalent vaccine, 2014-2015 formulation|0.5 mL, Intramuscular
16086950|NCT02258334|Biological|Fluzone I®ntradermal vaccine, 2014-2015 formulation|0.1 mL, Intradermal
16086951|NCT02258334|Biological|Fluzone® Quadrivalent vaccine, 2014-2015 formulation|0.5 mL, Intramuscular
16086952|NCT02258334|Biological|Fluzone High Dose vaccine, 2014-2015 formulation|0.5 mL, Intramuscular
16086953|NCT02258321|Drug|PPI-668 tablet|
16086954|NCT02258321|Drug|PPI-668 capsule|
16086955|NCT02258308|Behavioral|CHW intervention|Home education and support for asthma self management
16086956|NCT02258295|Drug|Intragel|Intragel has an average molecular weight of 800-1200 kDaltons.
16086957|NCT02258295|Drug|Saline|Saline
16086958|NCT02258282|Drug|Etanercept|
16086959|NCT02258282|Drug|Control|
16086960|NCT02258269|Other|SQ|
16086961|NCT02258269|Other|Control|
16086962|NCT02258256|Device|Sphygmo|A team of engineers from Rice University has recently developed Sphygmo, an ambulatory, low-cost blood pressure monitor for use in the diagnosis and management of pre-eclampsia in low-resource hospitals
16086963|NCT02258230|Device|3D mode of the 3D Laparoscopic Video System|Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.
16086964|NCT02258230|Device|2D mode of the 3D Laparoscopic Video System|Olympus 3DV-190 3D Visualization Unit. LTF-190-10-3D: ENDOEYE FLEX 3D Videoscope.
16086965|NCT02258217|Drug|Acthar|Is indicated for the treatment of acute exacerbations of multiple sclerosis in adults.
16086966|NCT02258204|Drug|Ketamine|Co-administration of subanesthetic dose of ketamine with tPA for thrombolysis in acute ischemic stroke.
16086967|NCT02258204|Drug|Placebo|
16086968|NCT02258191|Device|telemonitoring|
16086969|NCT02258191|Device|sham telemonitoring|
16086970|NCT02258178|Biological|Flucelvax (cTIV)|vaccine exposure in routine care (no vaccination per protocol)
16086971|NCT02258165|Device|PET/CT|"PET/CT (without respiratory gating) is performed on an ad-hoc basis in patients with advanced ovarian cancer in the lead up to surgery. The sensitivity of PET/CT for detecting low volume pleural disease is likely reduced by respiratory motion during the ten minute acquisition time over the chest. By freezing this respiratory motion with respiratory gating, we hope that gated PET/CT detection of pleural metastases will improve over non-gated PET images."
16086972|NCT02258152|Drug|SYN120|SYN120 Doses to be Administered: 20 mg QD (1 week titration), 50 mg QD (1 week titration), 100 mg QD (14 weeks of maintenance).
16086973|NCT02258152|Drug|Placebo|Placebo QD
16086974|NCT02258139|Device|B&L Investigational Contact Lens|The lens used in this study will be supplied by the Sponsor. All subjects will wear a -3.00D lens.
16086975|NCT02258126|Other|Multidisciplinary intervention program|"Exercise group:
~The intervention program includes an education program promoting healthy dietary habits and physical activity (nutritionist), supportive therapy and behavioral advice for the family to improve nutrition and physical activity (psychologist) (2 times/month, for children and parents) and supervised exercise (3 times/week, 90 mins) program for 6 months."
16086976|NCT02258113|Device|Ocusweep|A novel reaction-time based visual field device.
16086977|NCT02258113|Device|Ocusweep OcuRT|Vision based choice reaction time test method
16086978|NCT02258100|Other|Electronic Medical Record|Advent of EMR use for documentation of anesthetic care
16086979|NCT02258087|Radiation|LDR Brachytherapy|In spinal anaesthesia patients' prostate are treated with low-dose-rate or brachytherapy using transrectal ultrasound guidance. Radiation sources (iodine-125 isotopes) are implanted into the prostate through transperineal needle insertion. Real time dose planning is applied. The prescribed dose to the whole prostate is 145 Gy.
16086980|NCT02258087|Radiation|HDR Brachytherapy|In spinal anaesthesia patients' prostate are treated with one fraction of HDR brachytherapy. The prescribed dose to the whole prostate is 1x19 Gy. Ir-192 radioactive stepping source is used for the treatment with after-loading technique. Transperineal approach, rectal ultrasound guidance, inverse treatment planning, real time intraoperative needle position update and dose optimization is applied.
16086981|NCT02258074|Drug|Nicotinamide|
16086982|NCT02258074|Drug|Lanthanum Carbonate|
16086984|NCT02258074|Drug|Placebo (for lanthanum carbonate)|Sugar pill manufactured to mimic Lanthanum Carbonate 500 mg capsule
16086985|NCT02258061|Procedure|DDD-80|Basal pacing rate set to 80-bpm. Note:Patients have already pacemaker implanted before this study.
16086986|NCT02258061|Procedure|DDD-60|Basal pacing rate set to 60-bpm. Note:Patients have already pacemaker implanted before this study.
16086987|NCT02258035|Other|Blood draw|Sampling of 100-150 ml of blood
16086988|NCT02258009|Drug|Ranibizumab|0.5 mg intravitreal injections
16086989|NCT02258009|Drug|Aflibercept|2 mg intravitreal injections
16086990|NCT02257996|Behavioral|Online Systematic Brief Psychodynamic Psychotherapy|Systematic Adaptative Diagnosis System will be applied in both groups at two different times: pre-treatment and post-treatment
16086991|NCT02257983|Drug|EPI-743|EPI-743 (2 capsules 200 mg each) taken at a dose of 400 mg P.O. TID for 9 days with noise exposure for 4 hours on Day 8.
16086992|NCT02257983|Drug|Placebo|2 Placebo capsules P.O. TID for 9 days with noise exposure for 4 hours on Day 8.
16086993|NCT02257970|Drug|Ketoprofen|
16086994|NCT02257970|Drug|Placebo|Placebo to match ketoprofen.
16086995|NCT02257957|Drug|PRP injection|
16086996|NCT02257957|Drug|Standard care Hyaluronic acid eye drops|: 15 patients with diagnosis of severe dry eye will receive standard of care treatment ( Hyaluronic acid eye drops 5 times per day). Objective measurements as corneal staining, Shirmer , BUT, and VA, will be determinate as subjective measurements as OSDI and treatment compliance will be evaluated at day 0-30,60 and 90
16086997|NCT02257944|Behavioral|Motivational Interviewing|Brief hospital-based intervention, rooted in motivational interviewing
16086998|NCT02257944|Other|Treatment as Usual|treatment as usual
16086999|NCT02257918|Drug|AZD0914|AZD0914 is an antimicrobial amorphous nonsterile powder. Group 1 receive 2000 mg; Group 2 receive 3000 mg. The drug name is also known as ETX0914.
16087000|NCT02257918|Drug|Ceftriaxone|Ceftriaxone is a broad-spectrum cephalosporin antibiotic with a very long half-life and high penetrability to meninges, eyes and inner ears. A white to yellowish orange crystalline powder. Group 3 receives 500 mg reconstituted with 1 ml Lidocaine HCL 1%, intramuscularly.
16087001|NCT02257853|Other|Stress reduction intervention|Gentle chair yoga and breath work
16087002|NCT02257827|Radiation|IMRT|"The IMRT plan consisted of five - seven fields to deliver the same dose prescribed at the isodose line covering 95% of PTV.
~The 3DCRT plan consisted of six fields to deliver a total dose of 70 Gy/ 25 fractions of a single daily dose of 2.8 Gy."
16087003|NCT02257814|Behavioral|Incredible Years Teacher Training|
16087004|NCT02257814|Behavioral|Preschool PATHS|
16087005|NCT02257814|Behavioral|Tools of the Mind|
16087006|NCT02257801|Dietary Supplement|Nutritional beverage fortified with 6mg lutein/day|2 beverages (each containing 3mg lutein) per day (total of 6mg lutein/day) for a total of 4 months
16087007|NCT02257801|Dietary Supplement|Nutritional beverage fortified with 12mg lutein/day|2 beverages (each containing 6mg lutein) per day (total 12mg lutein/day) for a total of 4 months
16087008|NCT02257801|Dietary Supplement|Nutritional beverage fortified with 12mg lutein/day|2 beverages (each containing 0mg lutein) per day (total 0mg lutein/day) for a total of 4 months
16087009|NCT02257788|Biological|PRO 140|Humanized monoclonal antibody to CCR5
16087010|NCT02257775|Genetic|n/a - observational|
16087011|NCT02257762|Dietary Supplement|LNS|Compact, paste-filled wafer snack containing fish, rice, soy, mungbeans, oil, sugar and multiple micronutrients
16087012|NCT02257762|Dietary Supplement|Corn-soy blend ++ (CSB++)|Blended flour containing soy, corn, milk powder, oil, sugar and multiple micronutrients.
16087013|NCT02257762|Dietary Supplement|Sprinkles|Multiple micronutrient powder packaged in sachet.
16087014|NCT02257749|Other|Active Rehabilitation|The active rehabilitation intervention is a 6-week graded rehabilitation program, consisting of four components that are anchored in neuroscience evidence.The four components include: 1) aerobic exercise 2) coordination exercise 3) visualization 4) home program.
16087015|NCT02257749|Other|Comprehensive Education Intervention (Standard Care)|An initial education session will be provided by an occupational therapist related to general concussion information and outcomes, as well as strategies for symptom management following concussion.
16087016|NCT02257736|Drug|Apalutamide|Participants will receive 240 mg (4*60 mg tablets) of apalutamide once daily orally.
16087017|NCT02257736|Drug|Abiraterone acetate|Participants will receive 1000 mg (4*250 mg tablets) of abiraterone acetate (AA) once daily orally.
16087018|NCT02257736|Drug|Prednisone|Participants will receive 5 mg tablet of prednisone twice daily orally.
16087019|NCT02257736|Drug|Placebo|Participants will receive matching placebo to apalutamide once daily orally.
16087020|NCT02257723|Drug|Herbal medicine|Herbal medicine was taken 3 times daily in dried powder (2g) and water-base decoction form (120ml) (Ostericum koreanum, Eucommia ulmoides, Acanthopanax sessiliflorus, Achyranthes bidentata, Psoralea corylifolia, Peucedanum japonicum, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, and Atractylodes japonica).
16087021|NCT02257723|Procedure|Acupuncture|Acupuncture treatment was administered 1-2 times daily using mainly Ah-shi points and local acupuncture points.
16087022|NCT02257723|Procedure|Pharmacopuncture|Select ingredients similar to those included in the oral herbal medicine (Ostericum koreanum, Eucommia ulmoides, Acanthopanax Sessiliflorus, Achyranthes bidentata, Psoralea corylifolia, Peucedanum japonicum, Cibotium barometz, Lycium chinense, Boschniakia rossica, Cuscuta chinensis, and Atractylodes japonica) were freeze dried into powder form after decoction, then diluted in normal saline and adjusted for acidity and pH to be used in injections. The pharmacopuncture injections were injected once daily to the amount of 1 cc and Ah-shi points and local acupuncture points (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
16087023|NCT02257723|Procedure|Bee venom pharmacopuncture|Bee venom pharmacopuncture was applied after confirming a negative reaction to the hypersensitivity skin test. Diluted bee venom (saline:bee venom ratio, 10,000:1) was injected at 4-5 acupoints at the physician's discretion. Each acupuncture point was injected with approximately 0.2 cc to a total of 0.5-1 cc using disposable injection needles (CPL, 1 cc, 26G x 1.5 syringe, Shinchang medical co., Korea).
16087067|NCT02257398|Drug|Moxifloxacin placebo|Moxifloxacin placebo is available as white, film-coated tablet. containing nonactive material for single oral dose to be administered in the morning in the fasted state with approximately 240 mL of water.
16087024|NCT02257723|Procedure|Chuna manipulation|Chuna was administered 3-5 times a week. Chuna is a Korean version of spinal manipulation that incorporates conventional spinal manipulation techniques for mobilization involving high-velocity, low amplitude thrusts to joints slightly beyond the passive range of motion and gentle force to joints within the passive range of movement.
16087025|NCT02257710|Device|Orsiro|
16087026|NCT02257697|Drug|Mizoribine (MZR)|
16087027|NCT02257697|Drug|Cyclophosphamide (CTX)|
16087028|NCT02257684|Drug|pegcrisantaspase|
16087029|NCT02257671|Drug|Oral contraceptive|Neovletta
16087030|NCT02257658|Drug|Doxycycyline|
16087031|NCT02257658|Behavioral|Incentive|
16087032|NCT02257632|Drug|Ranibizumab 0.5 mg|Administered as an intravitreal injection
16087033|NCT02257632|Drug|Aflibercept 2 mg|Administered as an intravitreal injection
16087034|NCT02257619|Drug|Itacitinib|Itacitinib tablets administered orally at 400 mg QD for Part 1 of the study.
16087035|NCT02257619|Drug|docetaxel|Administered as an intravenous infusion in the clinic at 75 mg/m^2 Q3W for Part 1 of the study.
16087036|NCT02257606|Other|I-TRAVLE training|
16087037|NCT02257593|Other|Dietary protein|"Persons were fed
~Participants were randomized to one of three arms, each of which received 10%, 15% or 25% of total energy derived from protein"
16087038|NCT02257580|Drug|E-Aminocaproic acid|E-Aminocaproic acid (EACA) is a synthetic lysine analog that competitively inhibits the activation of plasminogen to plasmin and subsequently decreases the degree of fibrinolysis (Faraoni,2014} and is currently being used to decrease blood loss and transfusion requirements after orthopaedic procedures.(Eubanks,2010} Multiple meta analyses and retrospective and prospective studies have shown that EACA decreases blood loss and transfusion requirements after orthopaedic surgery{ McLeod,2013; Thompson, 2005; Thompson,2008; Gill,2008; Florentino-Pineda,2001}.Results from these studies also suggest that EACA will decreased post-operative morbidity, length of hospital stay, hospital costs, and complications.{Chimento,2013; Thompson,2005; Florentino-Pineda,2001}
16087039|NCT02257567|Drug|Bendamustine|Bendamustine 90 milligrams per meter-squared (mg/m^2) per day administered IV on Days 2 and 3 of Cycle 1, then on Days 1 and 2 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
16087040|NCT02257567|Drug|Obinutuzumab|Obinutuzumab 1000 milligrams (mg) IV on Days 1, 8, and 15 of Cycle 1 and on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
16087041|NCT02257567|Drug|Polatuzumab vedotin (Liquid)|Polatuzumab vedotin 1.8 milligrams per kilogram (mg/kg) administered IV on Day 2 of Cycle 1, then on Day 1 of each subsequent cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
16087042|NCT02257567|Drug|Rituximab|Rituximab standard dose, 375 mg/m^2 IV on Day 1 of each cycle for up to 6 cycles (each cycle is 21 days in DLBCL and 28 days in FL).
16087043|NCT02257567|Drug|Polatuzumab vedotin (Lyophilized)|Participants in the New Formulation (NF) Cohort (Arms G and H) will follow the same schedule and dosing requirements as participants in the other Phase II cohorts (Arms A-F).
16087044|NCT02257554|Behavioral|education|Discussion of surgical expectations with patients
16087045|NCT02257541|Drug|BGJ398|
16087046|NCT02257541|Drug|Imatinib Mesylate|
16087047|NCT02257528|Other|Laboratory Biomarker Analysis|Correlative studies
16087048|NCT02257528|Biological|Nivolumab|Given IV
16087049|NCT02257502|Drug|aflibercept|The patients are followed on a monthly basis until 52 weeks. Intravitreal injections of aflibercept at a dosage of 2 mg are initiated with a TAE regimen until 20 weeks (3 mandatory injections at inclusion, week 8 and 20 with reinjection at week 4, 12 and 16 only in case of CNV activity). Then, a PRN regimen is considered until 52 weeks (reinjection in case of CNV activity). Therefore, each patient receives between 3 and 13 injections in the whole study.
16087050|NCT02257489|Drug|ACE-083|recombinant fusion protein
16087051|NCT02257476|Drug|Carfilzomib|Carfilzomib will be given as an IV infusion over 4 hours. Subjects will remain at the clinic under observation for at least 1 hour following each dose of carfilzomib in Cycle 1 and following the dose on Cycle 2 Day 1. During these observation times, post dose IV hydration may be given at physician's discretion.
16087052|NCT02257476|Drug|Dexamethasone|Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses.
16087053|NCT02257463|Drug|theophylline, long acting bronchodilators (LABD) or combined LABD and inhaled steroids according to GOLD recommendations|
16087054|NCT02257463|Other|peripheral muscles exercise training|
16087055|NCT02257463|Device|inspiratory muscle training|Patients started breathing at a resistance that required generation of 30% of their PImax for one week. The load was then increased incrementally, 5-10%, to reach generation of 60% of their PImax at the end of the first month. Specific IMT was then continued at 60% of their PImax adjusted weekly to the new PImax achieved.
16087056|NCT02257437|Dietary Supplement|LNS snack|Compact, paste-filled wafer snack containing fish, rice, soy, mungbeans, oil, sugar and multiple micronutrients.
16087057|NCT02257437|Dietary Supplement|Corn-soy blend ++ (CSB++)|Blended flour containing soy, corn, milk powder, oil, sugar and multiple micronutrients.
16087058|NCT02257437|Dietary Supplement|Sprinkles|Multiple micronutrient powder packaged in sachet added to borbor (traditional white rice porridge).
16087059|NCT02257437|Dietary Supplement|LNS + borbor|Compact, paste-filled wafer snack containing fish, rice, soy, mungbeans, oil, sugar and multiple micronutrients added to borbor (traditional white rice porridge).
16087060|NCT02257424|Drug|Trametinib 2 mg daily|
16087061|NCT02257424|Drug|hydroxychloroquine (HCQ)|hydroxychloroquine (HCQ) is 600 mg orally every 12 hours
16087062|NCT02257424|Drug|dabrafenib 150 mg orally twice a day|
16087063|NCT02257411|Device|Ear-sized based|the sizes of the PLMA determined with the ear-based formula were compared with the sizes according to the manufacturer's weight-based formula
16087064|NCT02257398|Drug|GSK2140944|GSK2140944 is available in dose strength 1000 mg and 1800 mg for single IV dose over 2 hours administration as a pale yellow to greyish yellow cake for reconstitution
16087065|NCT02257398|Drug|GSK2140944 placebo|GSK2140944 placebo is 0.9% sodium chloride available for single IV dose over 2 hours administration.
16087066|NCT02257398|Drug|Moxifloxacin|Moxifloxacin is available as pinkish red tablet with dose strength 400 mg for single oral dose to be administered in the morning in the fasted state with approximately 240 mL of water.
16087098|NCT02257216|Other|Placebo|Cellulose
16087068|NCT02257385|Drug|UMEC/VI|ELLIPTA DPI will be supplied with 30 doses (2 strips with 30 blisters per strip) where first strip contains Umeclidinium bromide (unit dose strengths 62.5 mcg per blister) blended with lactose monohydrate and magnesium stearate 0.6% weight/weight (w/w) of total drug product and second strip contains Vilanterol (unit dose strengths 25 mcg per blister) blended with lactose monohydrate and magnesium stearate 1.0% w/w of total drug product
16087069|NCT02257385|Drug|UMEC/VI matching placebo|ELLIPTA DPI will be supplied with 30 doses (2 strips with 30 blisters per strip) where first strip contains lactose monohydrate and magnesium stearate 0.6% w/w of total drug product and second strip contains lactose monohydrate and magnesium stearate 1.0% w/w of total drug product
16087070|NCT02257385|Drug|Tiotropium|Tiotropium (as bromide monohydrate) inhalation capsules 18 mcg per dose will be supplied along with HANDIHALER inhalers manufactured by Boehringer Ingelheim
16087071|NCT02257385|Drug|Tiotropium matching placebo|Tiotropium matching placebo capsules manufactured by GSK, will contain lactose and will be supplied along with HANDIHALER inhalers
16087072|NCT02257385|Drug|Indacaterol|Indacaterol inhalation capsules 150 mcg per dose will be supplied by GSK along with BREEZHALER inhalers manufactured by Novartis
16087073|NCT02257385|Drug|Indacaterol matching placebo|Indacaterol matching placebo capsules manufactured by GSK, will contain lactose and will be supplied along with BREEZHALER inhalers manufactured by Novartis
16087074|NCT02257385|Drug|Albuterol/salbutamol Metered Dose Inhaler (MDI)|Albuterol/salbutamol MDI or nebules for as needed use will be issued throughout the study. Albuterol/salbutamol will be sourced from local commercial stock. If not available locally, GSK will source centrally
16087075|NCT02257372|Drug|UMEC DPI|The UMEC DPI will contain one blister strip which will have 30 blisters of UMEC as dry powder blended with lactose and magnesium stearate, with no companion strip. Each actuation of the DPI will deliver the contents of one blister from each strip simultaneously.
16087076|NCT02257372|Drug|Placebo DPI|The matching placebo DPI, identical in appearance to the inhaler containing active study medication, will have two blister strips, each containing 30 blisters of lactose and magnesium stearate.
16087077|NCT02257372|Drug|ICS/LABA medication|Participants will use ICS/LABA combinations that are approved for the treatment of COPD at approved doses and frequency including SERETIDE 500/50mcg twice daily, FSC 500/50 mcg twice daily generic products such as AIRFLUSAL FORSPIRO inhaler 500/50mcg twice daily or ROLENIUM ELPENHALER inhaler 500/50mcg twice daily and SYMBICORT TURBUHALER inhaler at doses of 200/6mcg twice daily and 400/12mcg twice daily. The ICS/LABA will be sourced from local commercial stock while on the study
16087078|NCT02257372|Drug|Albuterol/salbutamol Metered Dose Inhaler (MDI)|Albuterol/salbutamol MDI or nebules will be issued throughout the study as rescue medication, for use as-needed. Albuterol/salbutamol will be sourced from local commercial stock or provided centrally from GlaxoSmithKline.
16087079|NCT02257359|Drug|Epelsiban|Epelsiban will be supplied as a 25 mg white to off-white round direct compression oral tablet.
16087080|NCT02257346|Drug|Lidocaine|Lidocaine infusion will be administered immediately after delivery of the fetus and continue through 1 hour into recovery period.
16087081|NCT02257346|Drug|Normal Saline|Normal Saline will be administered as a placebo immediately after delivery of the fetus and continue through 1 hour into recovery period
16087082|NCT02257320|Device|TMJ NextGeneration(TM)|The TMJ NextGeneration(TM) device consists of a pair of small, hollow ear inserts. These ear inserts are custom-fit to each subject's ear canals. The devices rest in the outer third of the ear canal and have a small retraction post that allows for removal of the device from the ear. The devices conform to the shape of the ear canal when the jaw is in the open position and permit full passage of sound into each ear. The mechanisms of action of the inserts are to support the TMJ and associated secondary musculature to reduce strain in the TMJ area and to provide cognitive awareness to the wearer regarding para-functional habits, i.e., jaw clenching.
16087083|NCT02257307|Procedure|RetCam retinal imaging used for routine care|De-identified digital images of both eyes, obtained by a non-physician Certified ROP Imager (CRI) using the RetCam Shuttle, will be uploaded to the secure server for remote evaluation by a Trained Reader. The results of the Reader's evaluation will be reported to the Clinical Center.
16087084|NCT02257294|Drug|Alteplase|Single treatment consisting of a single slow infusion administration after reperfusion with aspiration thrombectomy ± angioplasty but before stenting during primary PCI.
16087085|NCT02257294|Other|Placebo|Single treatment consisting of a single slow infusion administration after reperfusion with aspiration thrombectomy ± angioplasty but before stenting during primary PCI.
16087086|NCT02257281|Device|Active Therapeutic Ultrasound|For Experimental Arm: The pulsed therapeutic ultrasound was applied each spot for several days.
16087087|NCT02257281|Device|Non-active Therapeutic Ultrasound|For Placebo group: The non-active therapeutic ultrasound was applied each spot for several days.
16087088|NCT02257268|Behavioral|VAMOS program - Active life improving health|All participants that will be assigned to change behavior group will participate of a change behavior program, entitled VAMOS (Active Life Improving Health), for 12 weeks. VAMOS is a lifestyle promotion program, that includes physical activity and healthy eating habits. The program is composed by a weekly meeting, in group, lasting about 90 min. In each weekly meeting, will be discussed guidelines and strategies for physical activities practices in different domains and for adoption of a healthy diet. All aspects and strategies included in the program are based in behavior changes theories. The participants of this group will receive an educational material and, in the middle of the program, they will earn a pedometer to aid in motivation and in the self-monitoring physical activity.
16087089|NCT02257255|Procedure|Pfannenstiel cesarean section|Pain scales ( VAS and McGill ) 6, 12 and 24 hours after cesarean to pain assessment
16087090|NCT02257255|Procedure|Misgav-Ladach cesarean section|Pain scales (VAS and McGill) 6, 12 and 24 hours ater cesarean to pain assessment
16087091|NCT02257242|Drug|Rituximab|375 mg/m2 I.V. on Day 1 of each cycle
16087092|NCT02257242|Drug|Bendamustine|90 mg/m2 I.V. on Day 1 and 2 of each cycle
16087093|NCT02257242|Drug|Vincristine sulfate liposome injection|Dose per dose escalation protocol, I.V. on Day 2 of each cycle
16087094|NCT02257229|Procedure|Surgical|Surgery only
16087095|NCT02257229|Procedure|Non-Surgical|non-surgical methods such as, casting, bracing, physical therapy, and other.
16087096|NCT02257229|Procedure|Non-surgical + surgical|Combination of non-surgical methods subsequently followed by surgery
16087097|NCT02257216|Other|Vayarin®|Medical Food
16087099|NCT02257203|Behavioral|Sugar Sweetened Beverage Education|Parents will receive an educational module on beverage just after the conclusion of their child's well visit in a private room adjacent to the clinic
16087100|NCT02257203|Behavioral|Reading Education|Parents randomized to control will receive a 25-minute educational module on the importance of reading to children with instruction in interactive reading techniques that are appropriate to the child's age
16087101|NCT02257190|Behavioral|Control|One hour of rest.
16087102|NCT02257190|Behavioral|IW3|A one hour exercise bout with repeated cycles of 3 min of fast and 3 min of slow walking
16087103|NCT02257190|Behavioral|IW1|A one hour exercise bout with repeated cycles of 1 min of fast and 1 min of slow walking
16087104|NCT02257177|Drug|Inhaled TD139|DPI Galectin-3 inhibitor
16087105|NCT02257177|Drug|Placebo|DPI placebo
16087106|NCT02257164|Procedure|Femoral nerve block|2 mg/ml
16087107|NCT02257164|Procedure|obturator nerve block|
16087108|NCT02257164|Procedure|intraarticular injection|
16087109|NCT02257151|Drug|BMS-986142|
16087110|NCT02257151|Drug|Placebo|
16087111|NCT02257138|Drug|Decitabine|Given IV
16087112|NCT02257138|Other|Laboratory Biomarker Analysis|Correlative studies
16087113|NCT02257138|Drug|Ruxolitinib Phosphate|Given PO
16087114|NCT02257125|Behavioral|high incentive|Subjects are required to use their arms in order to control a virtual arm on a computer screen to prevent meteors from destroying a planet. The game includes visual effects and monetary rewards.
16087115|NCT02257125|Behavioral|low incentive|"Subjects are required to use their arms in order to control a virtual hand on a computer screen to prevent objects from reaching the bottom. The game does not include visual effects or monetary rewards."
16087116|NCT02257112|Device|Multistage low-energy stimulation|The parameters of the Multistage waveform will be altered and the response of the atria will be recorded.
16087117|NCT02257073|Behavioral|Cognitive-behavioral treatment|
16087118|NCT02257073|Behavioral|Waiting List|
16087119|NCT02257060|Procedure|Endocardial Ablation|
16087120|NCT02257047|Dietary Supplement|Tea|
16087121|NCT02257047|Dietary Supplement|RYR|red yeast rice
16087122|NCT02257034|Other|Taichi|
16087123|NCT02257034|Other|Dance|
16087124|NCT02257021|Drug|BILR 355 BS|
16087125|NCT02257021|Drug|Tipranavir|
16087126|NCT02257021|Drug|Low dose of ritonavir|
16087127|NCT02257021|Drug|High dose of ritonavir|
16087128|NCT02257008|Drug|BILR 355 BS|
16087129|NCT02257008|Other|Grapefruit juice|
16087130|NCT02257008|Drug|Nelfinavir|
16087131|NCT02257008|Drug|Atazanavir|
16087132|NCT02257008|Drug|Ritonavir|
16087133|NCT02256995|Device|uChek|The uChek TM urine analyzer is a semi-automated urinalysis system, installed as an application on a smartphone. It makes use of a smartphone's camera to automatically read urine dipsticks.
16087134|NCT02256982|Drug|Gemcitabine|
16087135|NCT02256982|Drug|Cisplatin|
16087136|NCT02256982|Procedure|Surgery|Surgical Resection and Lymphadenectomy
16087137|NCT02256982|Radiation|Radiation|Radiation Therapy
16087138|NCT02256969|Drug|Blephamide|
16087139|NCT02256969|Drug|GenTeal PM Night-Time|
16087140|NCT02256969|Procedure|Meibomian Gland Probing|For anesthesia, topical 3.5% lidocaine hydrochloride jelly (Akron) was applied directly with sterile cotton-tipped applicator to the lid margin for 3 times every 10 minutes before the procedure. If necessary, 2% lidocaine was injected into the lid margin during the procedure to provide additional comfort. After obtaining adequate anesthesia, the solid stainless steel probes (Maskin® Meibomian Gland Intraductal Probes, Rhein Medical Inc.) were used to probe all the meibomian glands of upper lids of both eyes at the slit lamp. All patients were initially be probed with a 1-mm probe followed by a 2-mm probe for all glands.
16087141|NCT02256969|Procedure|Sham Meibomian Gland Probing|For anesthesia, topical 3.5% lidocaine hydrochloride jelly (Akron) was applied directly with sterile cotton-tipped applicator to the lid margin for 3 times every 10 minutes before the procedure. If necessary, 2% lidocaine was injected into the lid margin during the procedure to provide additional comfort. The patient's lid margin was touched with the probes without actual probing of the meibomian gland orifices.
16087142|NCT02256956|Drug|Amitriptyline|25 mg / day for 10 days
16087143|NCT02256956|Drug|Tolterodine|Placebo 1 mg / day for 10 days
16087144|NCT02256943|Drug|Amitriptyline|100 mg single dose
16087145|NCT02256943|Drug|Tolterodine|Placebo 1 mg single dose
16087146|NCT02256930|Drug|M518101|
16087147|NCT02256930|Drug|M518101 Vehicle|
16087148|NCT02256930|Other|Sodium lauryl sulfate|
16087149|NCT02256930|Other|Saline|
16087150|NCT02256917|Biological|Human cl rhFVIII|
16087151|NCT02256904|Procedure|Anatomical TKA|Personalized Medacta plastic cutting blocks will be manufactured according to patient Ct-scan.The anatomical cutting blocks will be design to resurface the femoral and tibial bones to restore each patient's pre-arthritic anatomy within specific margins: maximum of 5 degrees valgus/varus tibial or femoral cut and overall lower limb alignment within +/-3 degrees of varus/valgus). GMK sphere TKA will be implanted using the manufactured cutting blocks.
16087152|NCT02256904|Procedure|Mechanical TKA|Personalized Medacta plastic cutting blocks will be manufactured according to patient Ct-scan. In the mechanical group, femoral and tibial cutting blocks will be designed for a 0-degree angle according to the mechanical axis. Femoral rotation will be aligned with the femoral trans-epicondylar axis. Tibial rotation will follow femoral rotation. GMK sphere TKA will be implanted using the manufactured cutting blocks.
16087153|NCT02256891|Device|PRFM|
16087154|NCT02256891|Procedure|Double Row|
16087155|NCT02256878|Drug|BIRT 2584 XX|
16087156|NCT02256878|Drug|Amitriptyline|
16087157|NCT02256865|Drug|Ketoconazole|Ketoconazole is taken 4 times a day
16087158|NCT02256865|Drug|Hydrocortisone|Hydrocortisone is taken 3 times a day
16087159|NCT02256865|Drug|Testosterone|Testosterone gel is applied once a day
16087160|NCT02256865|Drug|Placebo for ketoconazole|Placebo for ketoconazole
16087161|NCT02256865|Drug|Placebo for hydrocortisone|Placebo for hydrocortisone
16087162|NCT02256865|Drug|Placebo for testosterone|Placebo for testosterone
16087163|NCT02256852|Biological|QBKPN SSI|QBKPN SSI is administered subcutaneously for 12 weeks
16087164|NCT02256839|Device|CST_001|
16087165|NCT02256826|Drug|BILR 355 BS|
16087166|NCT02256826|Drug|Ritonavir (RTV)|NORVIR®
16087167|NCT02256826|Drug|Kaletra®|(lopinavir (LPV) and ritonavir (RTV))
16087168|NCT02256813|Drug|BIRT 2584 XX|
16087169|NCT02256813|Drug|Warfarin sodium|
16087170|NCT02256813|Drug|Omeprazole|
16087171|NCT02256813|Drug|Dextromethorphan hydrobromide|
16087172|NCT02256813|Drug|Caffeine|
16087173|NCT02256813|Drug|Midazolam hydrochloride|
16087174|NCT02256813|Drug|Vitamin K1|
16087175|NCT02256800|Genetic|UGT1A1 genotyping (6,6)|"The investigators will use the regimen as following:
~Regimen for treatment consisted of bevacizumab (Avastin) 5mg/Kg (IV infusion) on day 1, follow by irinotecan (180 mg/m2 as a 120-min IV infusion), Leucovorin (400 mg/m2 IV infusion over 2 hours), and 5-FU (2800 mg/m2 IV infusion over a 46-hour period), repeated every 2 weeks.
~After 2 cycles of each different dose of irinotecan, we will observe the adverse effects (AEs) of hematological / non-hematological. If the grade is under the grade 2, we will escalate the dose of 30 mg/m2 gradually. The estimated maximal dose of irinotecan is 260 mg/m2."
16087176|NCT02256800|Genetic|UGTIA1 genotyping (6,7)|"The investigators will use the regimen as following:
~Regimen for treatment consisted of bevacizumab (Avastin) 5mg/Kg (IV infusion) on day 1, follow by irinotecan (180 mg/m2 as a 120-min IV infusion), Leucovorin (400 mg/m2 IV infusion over 2 hours), and 5-FU (2800 mg/m2 IV infusion over a 46-hour period), repeated every 2 weeks.
~After 2 cycles of each different dose of irinotecan, we will observe the adverse effects (AEs) of hematological / non-hematological. If the grade is under the grade 2, we will escalate the dose of 30 mg/m2 gradually. The estimated maximal dose of irinotecan is 240 mg/m2."
16087177|NCT02256800|Genetic|UGTIA1 genotyping (7,7)|"The investigators will use the regimen as following:
~Regimen for treatment consisted of bevacizumab (Avastin) 5mg/Kg (IV infusion) on day 1, follow by irinotecan (120 mg/m2 as a 120-min IV infusion), Leucovorin (400 mg/m2 IV infusion over 2 hours), and 5-FU (2800 mg/m2 IV infusion over a 46-hour period), repeated every 2 weeks.
~After 2 cycles of each different dose of irinotecan, we will observe the adverse effects (AEs) of hematological / non-hematological. If the grade is under the grade 2, we will escalate the dose of 30 mg/m2 gradually. The estimated maximal dose of irinotecan is 180 mg/m2."
16087178|NCT02256800|Genetic|UGT1A1 non-genotyping|"The investigators will use the regimen as following:
~Regimen for treatment consisted of bevacizumab (Avastin) 5mg/Kg (IV infusion) on day 1, follow by irinotecan (180 mg/m2 as a 120-min IV infusion), Leucovorin (400 mg/m2 IV infusion over 2 hours), and 5-FU (2800 mg/m2 IV infusion over a 46-hour period), repeated every 2 weeks."
16087179|NCT02256800|Drug|bevacizumab (Avastin)|
16087180|NCT02256800|Drug|irinotecan|
16087181|NCT02256800|Drug|Leucovorin|
16087182|NCT02256800|Drug|5-FU|
16087183|NCT02256787|Drug|BILB 1941 ZW - single rising dose part|
16087184|NCT02256787|Drug|Placebo|
16087185|NCT02256787|Drug|BILB 1941 ZW - solution|
16087186|NCT02256787|Drug|BILB 1941 ZW - tablet|
16087187|NCT02256787|Other|standardized breakfast|
16087188|NCT02256774|Drug|BILR 355 BS|
16087189|NCT02256774|Drug|Combivir®|
16087190|NCT02256774|Drug|Ritonavir|
16087191|NCT02256761|Drug|BIRT 2584 XX - multiple escalating dose|
16087192|NCT02256761|Drug|Placebo|
16087193|NCT02256761|Drug|BIRT 2584 XX - single dose|
16087194|NCT02256761|Other|high caloric meal|30 minutes prior to the second drug administration after a one week wash-out period, a standardised high fat, high caloric meal was served
16087195|NCT02256748|Drug|BIRT 2584 XX|
16087196|NCT02256748|Drug|Midazolam|
16087197|NCT02256735|Drug|Treatment A|Ritobegron Cl (KUC 7483 CL) tablets low dose
16087198|NCT02256735|Drug|Treatment B|
16087199|NCT02256735|Drug|Treatment C|
16087200|NCT02256735|Drug|Treatment D|
16087201|NCT02256735|Drug|Placebo|
16087202|NCT02256735|Drug|Moxifloxacin|
16087203|NCT02256722|Drug|KUC 7483 CL|
16087204|NCT02256722|Drug|Bisoprolol|
16087205|NCT02256722|Drug|Propranolol|
16087206|NCT02256722|Drug|Acipimox|
16087207|NCT02256722|Drug|Salmeterol|
16087208|NCT02256709|Drug|BIBP 5371 CL tablet|single rising daily doses
16087209|NCT02256709|Drug|BIBP 5371 CL solution|
16087210|NCT02256709|Other|High fat, high caloric breakfast|
16087211|NCT02256709|Drug|Placebo tablet|
16087212|NCT02256709|Drug|BIBP 5371 CL tablet high dose|
16087213|NCT02256709|Drug|Placebo drinking solution|
16087214|NCT02256709|Drug|BIBP 5371 CL tablet low dose|
16087215|NCT02256696|Drug|PA-824|200 mg QD
16087216|NCT02256696|Drug|Rifampin|600 mg QD
16087217|NCT02256696|Drug|Rifabutin|300 mg QD
16087218|NCT02256696|Drug|Pyrazinamide|25mg/kg QD
16087219|NCT02256696|Drug|Ethambutol|15mg/kg QD
16087220|NCT02256696|Drug|Isoniazid|300 mg QD
16087221|NCT02256683|Drug|Dabigatran etexilate|After inclusion of the patients with LAA thrombus, they are treated according to the randomization either with Pradaxa® (150 mg bid) or Marcumar® (INR 2-3) for at least three weeks. Thrombus resolution will be determined by transesophageal echocardiography (TEE) 3 weeks after start of treatment and subsequently at week 4 and 6 if necessary, i.e. LAA thrombus has not yet resolved. The study is terminated for each patient with the resolution of the LAA thrombus or after 6 weeks of study treatment.
16087222|NCT02256683|Drug|Phenprocoumon|After inclusion of the patients with LAA thrombus, they are treated according to the randomization either with Pradaxa® (150 mg bid) or Marcumar® (INR 2-3) for at least three weeks. Thrombus resolution will be determined by transesophageal echocardiography (TEE) 3 weeks after start of treatment and subsequently at week 4 and 6 if necessary, i.e. LAA thrombus has not yet resolved. The study is terminated for each patient with the resolution of the LAA thrombus or after 6 weeks of study treatment.
16087223|NCT02256670|Behavioral|Text Message Application|Two-way text messaging application addressing adherence with adjuvant endocrine therapy
16087307|NCT02255994|Procedure|No mesh.|Patients in this arm had subvesical plication without reinforcement.
16087309|NCT02255968|Drug|EDP-788|EDP-788 Capsules. All interventions are given as multiple doses.
16087224|NCT02256657|Behavioral|Quality Improvement Toolkit|The quality improvement toolkit is comprised of standardized admission and discharge checklists, clinical pathways, an audit and feedback mechanism through electronic data capture, and a monthly report used in conjunction with root cause analysis meetings. Quality improvement toolkits are implemented by individual hospitals.
16087225|NCT02256631|Biological|VRC01|Administered by subcutaneous injection in the thigh
16087226|NCT02256631|Biological|VRC01LS|Administered by subcutaneous injection in the thigh
16087227|NCT02256631|Biological|VRC07-523LS|Administered by subcutaneous injection in the thigh
16087228|NCT02256618|Other|Autologous umbilical cord blood cells|Autologous non-cryopreserved volume- and red blood cell-reduced cord blood cells will be intravenously infused
16087229|NCT02256605|Dietary Supplement|Vitamin D-3|Children with IBD, aged 5 to 17, who are vitamin D insufficient or deficient will be recruited at the time of a routine clinic visit or lab draw that included a 25(OH)D level as part of clinical practice/standard care. Once consent and assent are obtained, the children who are 25-hydroxyvitamin D [259OH)D] insufficient or deficient will be randomly assigned to a daily or weekly dosing regimen using block randomization to ensure equal group size.
16087230|NCT02256592|Drug|Fecal Microbiota|300 mL of fecal suspension from a healthy donor will be delivered during colonoscopy
16087231|NCT02256566|Behavioral|emotional memory training exercise|
16087232|NCT02256566|Behavioral|memory training exercise|
16087233|NCT02256553|Biological|MK-3641 12 Amb a 1-U (short ragweed extract)|12 units of Ambrosia artemisiifolia major allergen number 1 (Amb a 1-U) extract sublingual tablets
16087234|NCT02256553|Biological|MK-7243 2800 BAU (Timothy grass extract)|2800 bioequivalent allergen units (BAU) of Phleum pratense extract sublingual tablets
16087235|NCT02256553|Drug|Rescue Medication|Self-injectable epinephrine, to be administered for an anaphylactic reaction, including symptoms/signs of upper airway obstruction.
16087236|NCT02256540|Drug|Climara|
16087237|NCT02256540|Drug|Placebo patch|Placebo patch designed to match active Climara patches.
16087238|NCT02256540|Dietary Supplement|Resveratrol|
16087239|NCT02256540|Dietary Supplement|Placebo|Placebo tablets designed to match active resveratrol tablets.
16087240|NCT02256527|Other|Observational|compare data
16087241|NCT02256514|Biological|Daily oral dose of hepcortespenlisimut-L|Oral therapeutic vaccine, hepcortespenlisimut-L (V5) to be given once-per-day with monthly check-up
16087242|NCT02256501|Biological|Mono Nuclear Cell (MNC) transplantation|Intracoronary administration of autologous bone marrow derived mononuclear cells
16087243|NCT02256488|Biological|TIVc_LOT A|Single IM (Intramuscular) administration dose of 0.5 mL of TIVc
16087244|NCT02256488|Biological|TIVc_LOT B|Single IM administration dose of 0.5 mL of TIVc
16087245|NCT02256488|Biological|TIVc_LOT C|Single IM administration dose of 0.5 mL of TIVc
16087246|NCT02256488|Biological|TIVf|Single IM administration dose of 0.5 mL of TIVf
16087247|NCT02256475|Drug|NBI-98854|
16087248|NCT02256462|Drug|Adalimumab|Eligible patients are those who are planned to start Adalimumab (ADA). Patients will be randomized at the first screening visits to either group 1 (interventional) or group 2 (clinical). Eligible patients, will start induction treatment (weeks 0,2) with ADA (> 40kg 160/80/40 mg every 2 weeks or < 40 kg 100/50/25 mg for m2 body surface area every 2 weeks). Interventions will start from the 4th injection for responding patients only (based on levels taken prior to the third injection). Responding patients will continue to the maintenance phase in which they will receive ADA every 2 weeks, either 40 mg or 25 mg/m2. At screening, and every 2 months all patients will be examined and have height, weight, PCDAI performed as well as comprehensive laboratory examinations.
16087249|NCT02256436|Biological|pembrolizumab|IV infusion
16087250|NCT02256436|Drug|paclitaxel|IV infusion
16087251|NCT02256436|Drug|vinflunine|IV infusion
16087252|NCT02256436|Drug|docetaxel|IV infusion
16087253|NCT02256423|Drug|REFERENCE 1: Nurofen® 200 mg tablet|
16087254|NCT02256423|Drug|REFERENCE 2: Ibuprofen 200 mg soft gel capsule|
16087255|NCT02256423|Drug|ibuprofen 200 mg soft gel capsule|
16087256|NCT02256410|Device|Stimulation|The Nervomatrix device first measures skin impedance, and then creates a digital pain matrix map of the back. Regions with low resistance are then selected for brief electric stimulation, thus targeting the treatment to specific peak pain regions. Preliminary evidence supports the effectiveness of this device in reducing pain and disability over 6 sessions
16087257|NCT02256410|Other|Sham|The Nervomatrix device first measures skin impedance, and then creates a digital pain matrix map of the back. Regions with low resistance are then selected for brief mechanical pressure.
16087258|NCT02256397|Other|Standard comprehensive care|Standard comprehensive care at High Risk Children's Clinic
16087259|NCT02256397|Other|enhanced comprehensive care|"standard comprehensive care at the High Risk Children's Clinic enhaced with new technologies:
~If between 2 and 5 years old--> will receive Home-centered comprehensive care with the propeller
~5 and above--> will receive home-centered comprehensive care with propeller and PIKO"
16087260|NCT02256384|Device|Respiratory Acoustic Monitor|Examine the reliability and accuracy of the respiratory acoustic monitor.
16087261|NCT02256371|Behavioral|Hypnosis sessions|1 session per week during 8 weeks
16087262|NCT02256371|Behavioral|Relaxation group|1 relaxation session per week during 8 weeks
16087263|NCT02256358|Drug|Midazolam|preoperatively injected intravenous 0.1 mg/kg midazolam
16087264|NCT02256358|Drug|Ketamine|Preoperatively injected intravenous 1mg/kg ketamine
16087265|NCT02256345|Drug|KNO3|Active Comparator
16087266|NCT02256345|Drug|KCl|Placebo Comparator
16087267|NCT02256332|Dietary Supplement|Low dose plant based ingredient|Reference food with low dose of plant based ingredient
16087268|NCT02256332|Dietary Supplement|High dose plant based ingredient|Reference food with high dose of plant based ingredient
16087269|NCT02256332|Dietary Supplement|Reference food format|Reference food without plant-based ingredient
16087308|NCT02255981|Other|Acupuncture and massage|"Treatment consists in to put needles on specific points of skin one day each week initially, then with longer spaces of time according to improvement.A total of 11 Chinese needles stainless steel, 25 x 40 were used by manual insertion and left for 12-15 minutes.
~Periocular massage is taught and is practiced daily by the patient him or herself."
16087270|NCT02256319|Drug|Dexmedetomidine|Patients will receive a loading dose of 1 µg/kg in 10 min before starting the surgery. The maintenance dose will be 0.2-1 µg/kg/h for a Ramsey Sedation Score of 3-4 during the surgery´s preparation. It will be reduced to 0.2 µg/kg/h 15 min before starting the microelectrode recording for a Ramsey Sedation Score of 2. After the placement of the deep brain stimulator we will record the local field potentials activity. In addition, the subscales of rigidity, tremor and bradykinesia of the Unified Parkinson's Disease Rating Scale (UPDRS-III) score will be evaluated. Once the deep brain stimulator recording and neurologic exploration will be over patients will receive a maintenance dose 0.2-1 µg/kg/h until the end of the surgery. It will be stopped to transfer the patient to the ICU.
16087271|NCT02256319|Drug|Propofol|The target doses are 0.5, 1, 1.5, 2 and 2.5 µg/kg. For its administration we will use the TCI (target controlled infusion) system. After programming each dose we will wait until the plasma and brain concentration of propofol are stabilized in this target and then we will record the local field potentials activity through the DBS. In addition, the subscales of rigidity, tremor and bradykinesia of the UPDRS-III score will be evaluated.
16087272|NCT02256306|Other|Plasma|1 unit of Plasma From Young Donors (Male, aged 30 or younger)
16087273|NCT02256293|Behavioral|Diabetes self-management group based on Acceptance and Commitment Therapy (ACT).|The group sessions will be lead by a clinician trained in Acceptance and Commitment Therapy and will meet at Duke Medical Center for 1 ½ hours once a week for a total of 8 weeks. During group sessions, participants will identify how avoidance of difficult thoughts and feelings about diabetes has interfered with diabetes management and learn alternative ways of coping with these experiences. The group sessions are intended to supplement regular medical treatment; thus it is important that subjects continue to have diabetes symptoms monitored by their current treatment provider.
16087274|NCT02256280|Drug|Sugammadex|"Sugammadex will be diluted in a saline water solution in a 10 mL syringe.
~Administration will be according to the neuromuscular blockade:
~If Post tetanic count = 1-15: 4 mg/kg
~If at least 1 twitch at the Train-of-four stimulation: 2 mg/kg"
16087275|NCT02256280|Drug|Neostigmine|"Neostigmine will be diluted with atropine in a saline water solution in a 10 mL syringe.
~Administration will be according to the neuromuscular blockade:
~If Post tetanic count = 1-15: 0.07 mg/kg
~If at least 1 twitch at the Train-of-four stimulation: 0.05 mg/kg Atropine will be administered at a 0.02 mg/kg dosage."
16087276|NCT02256267|Drug|LY2835219|Administered orally
16087277|NCT02256267|Drug|Rifampin|Administered orally
16087278|NCT02256254|Drug|Simvastatin|2 Simvastatin capsules of 20 mg every evening for 14 days
16087279|NCT02256254|Drug|Placebo|2 placebo capsules every evening for 14 days
16087280|NCT02256228|Drug|Ropivacaine|Active Group
16087281|NCT02256228|Drug|Saline|Placebo Comparator
16087282|NCT02256215|Drug|Vitamin D|
16087283|NCT02256202|Other|Interview|Monitoring interviews to show medical and economic advantages of given therapy
16087284|NCT02256189|Drug|Sitagliptin|Sitagliptin 100 mg daily
16087285|NCT02256189|Drug|Placebo|Placebo one tablet daily
16087286|NCT02256150|Drug|Mizoribine (MZR)|
16087287|NCT02256150|Drug|Cyclophosphamide (CTX)|
16087288|NCT02256124|Drug|Lamotrigine|
16087289|NCT02256124|Drug|Placebo|
16087290|NCT02256111|Drug|Enzalutamide|
16087291|NCT02256111|Drug|Androgen deprivation therapy|
16087292|NCT02256111|Behavioral|Supervised exercise training|
16087293|NCT02256098|Device|ATTUNE™ Knee Prosthesis by DePuy|Total Knee Replacement (TKR) Surgery with ATTUNE™ Knee Prosthesis by DePuy
16087294|NCT02256098|Device|PFC Sigma Knee Prosthesis by DePuy|Total Knee Replacement Surgery with PFC Sigma Knee Prosthesis by DePuy
16087295|NCT02256085|Device|Daily rTMS with Active coil|rTMS produces strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for six weeks
16087296|NCT02256085|Device|Daily rTMS with Sham coil|rTMS produces strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for six weeks
16087297|NCT02256085|Device|Open Label Daily rTMS with Active coil|rTMS produces strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for six weeks
16087298|NCT02256072|Other|Plan Your Lifespan Website|Participants in the intervention arm will navigate the advance planning tool, Plan Your Lifespan, a Web-based planning tool that provides information for seniors related to advanced health planning for home services in specific content areas of: hospitalizations, falls, Alzheimer's, dementia, as well as communicating with others. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating this website.The Plan Your Lifespan website is also interactive in that it allows participants to enter their information and share it with others to facilitate conversations and decision-making.
16087299|NCT02256072|Other|Go4Life Website|Participants in the attention control arm will navigate an electronic educational session via a National Institute on Aging at NIH Website, Go4Life, a website about physical activity and exercise as it is a topic of interest to seniors. A minimum of 15 minutes and a maximum of 45 minutes will be allotted for navigating the website. The website is interactive and comparable to the intervention tool: http://go4life.nia.nih.gov/get-started).
16087300|NCT02256059|Procedure|Plate osteosynthesis|Plate osteosynthesis using LCP plate (Synthes)
16087301|NCT02256046|Device|Esophagogastroduodenoscope|Endoscopic therapies for varices aim to reduce variceal wall tension by obliteration of the varix. The two principal methods available for esophageal varices are endoscopic sclerotherapy (EST) and band ligation (EBL). Endoscopic therapy is a local treatment that has no effect on the pathophysiological mechanisms that lead to portal hypertension and variceal rupture. However, a spontaneous decrease in HVPG occurs in around 30% of patients treated with either EST or EBL to prevent variceal rebleeding.
16087302|NCT02256033|Drug|Istradefylline|One 40 mg-tablet administered on Day 1
16087303|NCT02256020|Other|Original lifestyle|Control group with 3 times of watching 50-minute television a week for 6 months.
16087304|NCT02256020|Other|Wheel-chair music aerobic exercise (WC-MAE)|Wheel-chair music aerobic exercise with 3 times of 50-minute session a week for 6 months.
16087305|NCT02256007|Other|Paper and Pencil Assessments|Videogame Assessments
16087306|NCT02255994|Device|UGYTEX|Patients in this arm received the UGYTEX mesh in the pro-cure 1 study (see NCT00153257)
16087310|NCT02255968|Drug|Placebo|Matching placebo capsules. All interventions are given as multiple doses
16087311|NCT02255955|Drug|550 mg naproxen sodium and 30mg codeine|Postoperative contramal consumption, pain intensity, side effects
16087312|NCT02255955|Drug|300 mg paracetamol and 30 mg codeine|Postoperative contramal consumption, pain intensity, side effects
16087313|NCT02255955|Drug|placebo tablet|Postoperative contramal consumption, pain intensity, side effects
16087314|NCT02255942|Other|Ferric Pyrophosphate and Zinc Oxide|Rice fortified with Ferric Pyrophosphate and Zinc Oxide (ZnO)
16087315|NCT02255942|Other|Ferrous sulfate|Rice fortified with Ferrous Sulfate (ZnSO4)
16087316|NCT02255942|Other|Ferric Pyrophosphate and Zinc Sulfate|Rice fortified with Ferric Pyrophosphate and Zinc Sulfate
16087317|NCT02255942|Other|Ferric Pyrophosphate|Rice fortified with Ferric Pyrophosphate
16087318|NCT02255929|Radiation|Gamma Knife Radiosurgery|
16087319|NCT02255916|Other|Music|live sound-bed music intervention
16087320|NCT02255903|Other|ultrasound and Doppler examination|ultrasound and Doppler examination: Trans-abdominal ultrasound examination will be peformed to all patienst while women in a slightly tilted position with the head of the bed raised 30 degrees and with a small pillow under the right lion
16087321|NCT02255877|Device|Zip Surgical Skin Closure|Non invasive skin closure device for closure of the skin layer for surgical incisions or laceration repair.
16087322|NCT02255877|Device|Steel Staples|Skin Closure device for the closure of the skin layer for surgical incisions.
16087323|NCT02255864|Device|AmM FORTITUDE Bioresorbable Drug-Eluting Coronary Scaffold|Placement of the investigational device into the diseased coronary artery to eliminate the vascular stenosis.
16087324|NCT02255851|Device|SENTINEL (Cerebral Protection System)|
16087325|NCT02255838|Device|Bronchoscope reusable (Storz 8402 2x)|Bronchoscopy and alveolar lavage
16087326|NCT02255838|Device|Bronchoscope disposable (aScope 4)|Bronchoscopy and alveolar lavage
16087327|NCT02255825|Genetic|Whole Genome Sequencing|Whole genome sequencing in a CLIA lab and return of results.
16087328|NCT02255825|Procedure|Amniocentesis|Note: this is being performed on all subjects as a clinical (not research) procedure
16087329|NCT02255825|Other|Psychosocial assessment|Use of EPDS and STAI for assessment of maternal and paternal mood
16087330|NCT02255812|Dietary Supplement|Single intragastric instillation of 200 mL tap water via nasogastric tube|
16087331|NCT02255812|Dietary Supplement|Single intragastric instillation of 2 g citric acid in 200 mL tap water via nasogastric tube|
16087332|NCT02255812|Dietary Supplement|Single intragastric instillation of 2 g salt in 200 mL tap water via nasogastric tube|
16087333|NCT02255812|Dietary Supplement|Single intragastric instillation of 0.017 g quinine in 200 mL tap water via nasogastric tube|
16087334|NCT02255812|Dietary Supplement|Single intragastric instillation of 1 g monosodium glutamate in 200 mL tap water via nasogastric tube|
16087335|NCT02255812|Dietary Supplement|Single intragastric instillation of 25 g glucose in 200 mL tap water via nasogastric tube|
16087336|NCT02255799|Drug|Donepezil|Donepezil 5 mg capsule daily for 14 days. Donepezil 10 mg capsule daily for 56 days.
16087337|NCT02255799|Drug|Placebo|Placebo capsule once daily for 70 days.
16087338|NCT02255786|Behavioral|Acceptance and Commitment Therapy|Acceptance and Commitment Therapy (ACT) is an intervention that fosters acceptance of uncomfortable thoughts and emotions as a coping strategy, and encourages engagement in valued behavior in the presence of these emotions. ACT has been successfully applied to parents of children with a variety of mental health presentations.
16087339|NCT02255773|Behavioral|Computerized Tasks|3 computerized tasks completed to assess motivation, learning of goal-directed and habitual behavior, and flexibility in switching between behavior strategies. It should take about 60 minutes to complete all three tasks.
16087340|NCT02255773|Behavioral|Questionnaires|Completion of 8 questionnaires about mood, fatigue, sleep quality, and other symptoms. It should take about 30 minutes to complete these questionnaires.
16087341|NCT02255760|Drug|MEDI3902 - Dose 1|Participants will receive a single IV dose of MEDI3902 infused for a minimum of 13 minutes on Day 1.
16087342|NCT02255760|Drug|MEDI3902 - Dose 2|Participants will receive a single IV dose of MEDI3902 infused for a minimum of 38 minutes on Day 1.
16087343|NCT02255760|Drug|MEDI3902 - Dose 3|Participants will receive a single IV dose of MEDI3902 infused for a minimum of 75 minutes on Day 1.
16087344|NCT02255760|Drug|MEDI3902 - Dose 4|Participants will received a single IV dose of MEDI3902 infused for a minimum of 150 minutes on Day 1.
16087345|NCT02255760|Other|Placebo|Participants will receive a single dose of placebo by IV infusion up to a maximum of 12 hours.
16087346|NCT02255747|Drug|Lactulose|
16087347|NCT02255734|Drug|Acyclovir|
16087348|NCT02255721|Behavioral|SHIP (Sleep Health in Preschoolers)|SHIP (Sleep Health in Preschoolers) is a family-centered health behavior change intervention for child behavioral sleep problems delivered 1:1 to parents via a home visit and follow-up phone calls.
16087349|NCT02255721|Behavioral|SHIP Control Arm|Families will receive a family-centered health behavior change intervention for child health topics unrelated to sleep or outcome measures, delivered 1:1 to parents via a home visit and follow-up phone calls.
16087350|NCT02255708|Other|Proprioceptive Neuromuscular Facilitation - PNF|
16087351|NCT02255695|Other|School-based exercise program|The exercise program was applied, twice a week, for 8 weeks, with sessions of 50 minutes, in groups of 10 students. The exercise program was elaborate to restore muscular balance through flexibility, endurance and muscular strength. To promote flexibility stretching exercises for rotator neck muscles, lateral neck flexors, levator scapulae, upper trapezius, erector spinae, major and minor pectoralis, rhomboids, spinal lateral flexors, column rotators, piriformis, hamstrings, quadriceps, hip adductors and abductors were applied. Strengthening exercises were applied for the development of strength, endurance and control of deep flexor muscles of the cervical spine, stabilizers of the glenohumeral joint and scapula, abdominals, spine extensors and hip extensors.
16087352|NCT02255682|Drug|Simvastatin|
16087353|NCT02255682|Dietary Supplement|Q10|
16087354|NCT02255669|Device|partially covered SEMS|Used for palliation of inoperable malignant distal bile duct obstruction.
16087355|NCT02255669|Device|fully covered SEMS|Used for palliation of inoperable malignant distal bile duct obstruction.
16087478|NCT02254824|Drug|Atorvastatin|Atorvastatin
16087356|NCT02255656|Drug|alemtuzumab GZ402673|Pharmaceutical form:concentrate for solution for infusion Route of administration: intravenous
16087357|NCT02255643|Device|Change of PMT setting|The patients current motor threshold is determined and the patient is set to a new PMT (= new treatment arm)
16087358|NCT02255630|Other|Cycling Exercise|
16087359|NCT02255617|Biological|Fecal Microbiota Transplant|Fecal transplant processed from routinely screened universal donors
16087360|NCT02255604|Drug|Alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.|4
16087361|NCT02255604|Drug|alk (225) Phleum Pratense. 0.1 ml of 10,000 standard quantity units/ml.|3 injection into a lymphnode
16087362|NCT02255604|Drug|0.1 ml Isoton saline|4 injection into a lymphnode
16087363|NCT02255591|Drug|Lidocaine-adrenaline added gadolinium.|
16087364|NCT02255578|Device|Endobarrier treatment in PCOS|the effect of an EndoBarrier device on fertility and metabolic parameters in obese insulin resistant (IR) PCOS women
16087365|NCT02255578|Drug|clomiphene citrate treatment|
16087366|NCT02255565|Drug|Very Low Dose Quillivant XR|Oral suspension dose once a day increasing to a 10mg dose
16087367|NCT02255565|Drug|Low Dose Quillivant XR|Oral suspension dose once a day increasing to a 20mg dose
16087368|NCT02255565|Drug|Moderate Dose Quillivant XR|Oral suspension dose once a day increasing to a 40mg dose
16087369|NCT02255552|Drug|eteplirsen|Eteplirsen 30 mg/kg will be administered as an IV infusion once a week for 96 weeks, followed by a safety extension (not to exceed 48 weeks).
16087370|NCT02255539|Device|Geelong Prototype Mask|A nasal pillows prototype mask to be trialled with a PAP therapy device for a period of 6 weeks. Participants will wear the mask in place of their current mask for the duration of the trial.
16087371|NCT02255526|Device|BodyGuardian|BodyGuardian (BG) device will be worn by all subjects to determine accuracy of respiration and activity levels monitored by BG
16087372|NCT02255513|Drug|HLD200|
16087373|NCT02255513|Drug|Placebo|
16087374|NCT02255500|Drug|Bupivacaine FNB|A single administration of bupivacaine HCl 0.5% with epinephrine 1:200,000 in 20 mL volume will be administered within 2 hours prior to the surgical procedure as an ultrasound-guided FNB.
16087375|NCT02255500|Drug|EXPAREL Infiltration|A single dose of EXPAREL 266 mg expanded to 60 mL with preservative-free sterile normal saline will be infiltrated into the surgical site just prior to wound closure.
16087376|NCT02255487|Device|IrriSept System|"The IrriSept system consists of two containers: Step1, a sterile bottle of 450 mL 0.05% Chlorhexidine Gluconate in 99.95% water and Step 2, a sterile bottle of 450 mL of sterile 0.9% Normal Saline. Step 1 and Step 2 are identical in shape and size, with a clear distinction in labeling between. Their unique design allows the solutions to be delivered under the ideal pressure as determined by the surgeon via manual compression for wound and surgical irrigation.
~Subjects randomized to the IrriSept system will receive irrigation per the provided Instructions for use; those randomized to Standard of Care will receive routine care per discretion of the investigator and in accordance with the institution's guidelines, which may or may not include some other type of irrigation."
16087377|NCT02255487|Other|No Intervention - Standard of Care (SoC) only|Institution will provide routine Standard of Care (SoC) only surgical preparation for subjects with abdominal trauma or acute surgical abdomen.
16087378|NCT02255474|Device|Biofinity Multifocal D +1.50 add|This is a monthly disposable contact lens commercially available from CooperVision
16087379|NCT02255474|Device|Biofinity Multifocal D +2.50 add|This is a monthly disposable contact lens commercially available from CooperVision
16087380|NCT02255474|Device|Biofinity|This is a monthly disposable spherical contact lens commercially available from CooperVision
16087381|NCT02255461|Drug|palbociclib isethionate|Given PO
16087382|NCT02255461|Other|pharmacological study|Correlative studies
16087383|NCT02255461|Other|laboratory biomarker analysis|Correlative studies
16087384|NCT02255448|Device|Transthoracic echo and esCCO stroke volume|All participants will have their cardiac outputs measured using these two devices simultaneously. Cardiac output 1 will include measurements made using transthoracic echo and cardiac output 2 will be done using esCCO device.
16087385|NCT02255435|Drug|Omaveloxolone Capsules, 2.5 mg|
16087386|NCT02255435|Drug|Omaveloxolone Capsules, 5 mg|
16087387|NCT02255435|Drug|Omaveloxolone Capsules, 10 mg|
16087388|NCT02255435|Drug|Placebo|
16087389|NCT02255435|Drug|Omaveloxolone Capsules, 20 mg|
16087390|NCT02255435|Drug|Omaveloxolone Capsules, 40 mg|
16087391|NCT02255435|Drug|Omaveloxolone Capsules, 80 mg|
16087392|NCT02255435|Drug|Omaveloxolone Capsules, 160 mg|
16087393|NCT02255435|Drug|Omaveloxolone Capsules, 300 mg|
16087394|NCT02255435|Drug|Omaveloxolone Capsules, 150 mg|
16087395|NCT02255422|Drug|Omaveloxolone capsules, 2.5 mg|
16087396|NCT02255422|Drug|omaveloxolone capsules, 5 mg|
16087397|NCT02255422|Drug|omaveloxolone capsules, 10 mg|
16087398|NCT02255422|Drug|Placebo capsules|
16087399|NCT02255422|Drug|omaveloxolone capsules, 20 mg|
16087400|NCT02255422|Drug|omaveloxolone capsules, 40 mg|
16087401|NCT02255422|Drug|omaveloxolone capsules, 80 mg|
16087402|NCT02255422|Drug|omaveloxolone capsules, 160 mg|
16087403|NCT02255409|Biological|Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)|1 dose 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months
16087404|NCT02255409|Biological|non-adjuvanted Quadrivalent Influenza Vaccine (QIV)|1 dose 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months
16087405|NCT02255396|Other|ESTRADIOL|
16087407|NCT02255370|Drug|Curcumin|subjects will be randomized into two arms; they will be given either placebo or curcumin 3g/d per os plus thiopurines during 6 months in a double-blind manner. Rutggerts endoscopic score at 6 months will be the main judgment criteria
16087408|NCT02255357|Drug|Placebo|Solution containing only the excipients of the original solution without Oxytocin.
16087409|NCT02255357|Drug|Intranasal Oxytocin|solution containing Oxytocin 6 IU/0.1cc or per puff is used in this arm
16087410|NCT02255318|Device|Taurolock|
16087411|NCT02255318|Drug|Placebo|
16087479|NCT02254824|Behavioral|Lifestyle modification|Lifestyle modification
16087412|NCT02255305|Biological|FMT|Patients in the FMT group will receive ~50 grams of fecal material suspended in bacteriostatic normal saline and glycerol.
16087413|NCT02255305|Drug|Antimicrobials|Patients randomized to the control group will receive antimicrobials targeting C. difficile.
16087414|NCT02255292|Drug|cannabidiol (CBD)|Patients with confirmed solid cancer, after progression of all the available standard therapy or unfit to standard therapy according to oncologist's view, measurable disease as determined by RECIST using CT, life expectancy of at least 6 months, Eastern Cooperative Oncology Group (ECOG) performance status < or = 2 and aged 18 years old and more will be included in the current study
16087415|NCT02255279|Biological|Adjuvanted Trivalent Influenza Vaccine, 1 dose for non-naive subjects (day 1), two doses for naive subjects (day 1 and day 29)|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of aTIV, a trivalent (surface antigen, formaldehyde-inactivated) influenza virus vaccine, adjuvanted with MF59C.1, administered at day 1 (for all subjects) and day 29 (for naïve subjects).
16087416|NCT02255279|Biological|Non-adjuvanted Trivalent Influenza Vaccine, 1 dose for non-naive subjects (day 1), two doses for naive subjects (day 1 and day 29).|A 0.25 mL (for children 6 to <36 months old) and 0.5 mL (for children ≥36 months to < 72 months old) dose of TIV , an egg-derived trivalent split influenza vaccine licensed in Mexico, administered at day 1 (for all subjects) and day 29 (for naïve subjects)
16087417|NCT02255266|Drug|liraglutide|No treatment given.
16087418|NCT02255253|Drug|Telmisartan|capsule,40mg per day,2 months
16087419|NCT02255253|Drug|Hydrochlorothiazide|tablet, 25mg per day, 2 months
16087420|NCT02255240|Behavioral|Physical activity intervention|Participants will receive counseling on self-regulatory skill building that has been adapted to complement the video games used. We anticipate that the games used will consist of fitness, sports, and dance games and will be played on a Wii U console. The games played will be chosen by each participant from a pool of potential appropriate games.
16087421|NCT02255227|Biological|Prevenar 13|one dose for arm 1 and 2 doses for arm 2
16087422|NCT02255227|Biological|Pneumo 23|one dose
16087423|NCT02255201|Dietary Supplement|Master Performance Blend Dose 1|Caffeine content: 200 mg
16087424|NCT02255201|Dietary Supplement|Master Performance Blend Dose 2|Caffeine content: 400 mg
16087425|NCT02255201|Dietary Supplement|Performance Energy Blend|Caffeine content: 175 mg
16087426|NCT02255201|Dietary Supplement|Energy Blend|Caffeine content: 200 mg
16087427|NCT02255201|Dietary Supplement|Placebo|Caffeine content: 0 mg
16087428|NCT02255188|Procedure|blood sampling procedure|30 ml of venous blood will be collected from all voluteers using a special vacuum tubes after informed consent. Blood sampling is carried out from an arm vein. All subsequent studies will be executed in the laboratory diagnostic division of Novosibirsk Research Institute of Circulation Pathology and the presence of the donors is unnecessary
16087429|NCT02255175|Drug|Estradiol|Participants will receive transdermal estradiol (100μg/day) for 3 weeks
16087430|NCT02255175|Drug|Progesterone|Participants will receive an additional week of combined estradiol and micronized progesterone (200 mg/day) at the end of the study to precipitate menstruation.
16087431|NCT02255162|Drug|Lenalidomide|Patients will receive lenalidomide starting on day 6 of each post-remission cycle, following conclusion of cytarabine post-remission therapy on days 1-5. Following count recovery in the third post-remission cycle, patients will then receive lenalidomide daily as a maintenance therapy.
16087432|NCT02255162|Genetic|HLA-mismatched stem-cell Microtransplantation|Patient will receive HLA-mismatched stem cell microtransplant infusion on day 6 of each post-remission cycle, following conclusion of course of cytarabine in each cycle.
16087433|NCT02255162|Drug|Cytarabine|Patients will receive cytarabine post-remission therapy for 3 cycles, on days 1-5 of each cycle.
16087434|NCT02255149|Device|Bone/Mesh|A titanium mesh (Ti-Mesh) that is more porous than other materials will be placed in order to hold a spot for the bone particles to grow.
16087435|NCT02255136|Other|Individualized homeopathic medicines|5 ml dose of indicated individualized homeopathic medicine in centesimal or 50 millesimal potencies as appropriate; twice daily for 1 year
16087436|NCT02255136|Other|Placebo|Placebo, in the form of a single drop of rectified spirit in 5 ml of distilled water
16087437|NCT02255110|Drug|TH-302|TH-302 will be administered at a dose of 300 milligram per square meter (mg/m^2) by intravenous infusion over 30 minutes on Days 1 and 8 of every 21-day cycle until the evidence of significant treatment-related toxicity or progressive disease.
16087438|NCT02255110|Drug|Doxorubicin|Doxorubicin will be administered at a dose of 75 mg/m^2 by intravenous injection (over at least 5 minutes) or by intravenous infusion over 6-96 hours on Day 1 of every 21-day cycle starting 2 to 4 hours after completion of TH-302 administration until the evidence of significant treatment-related toxicity or progressive disease.
16087439|NCT02255097|Biological|pembrolizumab|
16087440|NCT02255084|Behavioral|Group 1 remove self sample kit at gp consulting room or perform pap smear|"Selected general practitioners are briefly informed about the study and they receive a package of kits for vaginal self-sampling.
~Selected women receive a mail inviting them either to remove a kit for vaginal self-sampling at their general practitioner's consulting room or to perform a pap smear. When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory."
16087441|NCT02255084|Behavioral|Group 2 perform self sample at home or pap smear|"Selected general practitioners are briefly informed about the study. Selected women receive a mail inviting them either to perform a vaginal self sampling at their home (with the kit provided) or to perform a pap smear.
~When women choose the vaginal self-sampling, a HPV test is performed on the sample in a virology laboratory."
16087442|NCT02255071|Device|Acupressure wristband|A acupressure wristband over Neiguan (P6 point) and acupressure for seven days.
16087443|NCT02255071|Device|Sham wristband|A wristband over wrist but no acupressure for seven days.
16087444|NCT02255058|Other|No intervention|The study is a Prospective observational cohort study
16087445|NCT02255045|Drug|Meloxicam|1 Meloxicam Vaginal Ring (MVR) for 4-6 days
16087446|NCT02255045|Drug|Diclofenac Potassium|1 tablet 50 mg diclofenac every 12 hours for 4-6 days
16087447|NCT02255045|Drug|Placebo Oral|1 placebo tablet every 12 hours for 4-6 days
16087448|NCT02255045|Drug|Placebo Vaginal|1 placebo vaginal ring for 4-6 days
16087570|NCT02254226|Drug|Salmeterol Diskus high|
16087449|NCT02255032|Drug|4 mg CLS-TA|40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
16087450|NCT02255032|Drug|0.8 mg CLS-TA|8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)
16087451|NCT02255006|Device|Active acupuncture|Active acupuncture treatment group receive electroacupuncture (EA). For EA treatment, unilateral acupuncture meridian point Pericardium5 (PC5), Pericardium6 (PC6), Stomach36 (ST36), and Stomach37 (ST37) are chosen. Disposable, sterile needles and low frequency electrical stimulator (ES-160, ITO, Japan) are used. Each needle is inserted to the depth of 2cm with a 90 degree angle. Thereafter, needles are connected with the pole and electrical stimulation is applied with 2 Hertz continuous wave current. After FMD measurement, a pneumatic cuff placed above the upper arms is inflated to 200 mmHg for 15 minutes. The cuff is then deflated, and 15 minutes of reperfusion is allowed before FMD measurement again. Acupuncture is performed from after ten minutes of ischemia till end time of reperfusion
16087452|NCT02255006|Device|Sham acupuncture|"For sham intervention, nonacupuncture points are used. Electrical acupuncture is connected but electrical stimulation is not given to sham acupuncture group.
~Volunteers undergo FMD measurement and acupuncture like above methods."
16087453|NCT02255006|Drug|Euglucon 5mg|8 healthy volunteers are administered 5 mg of glibenclamide (Euglucon, Roche Pharma) 3 hour before FMD measurement. This dosage has previously been shown to be able to completely inhibit forearm KATP channels. With the glibenclamide administration, a 10% dextrose infusion is started and titrated to maintain blood sugar levels between 80 and 120 mg/dL throughout the study period. 3 hours after glibenclamide administration, the subjects undergo FMD measurement before and after ischemia reperfusion injury. During ischemia reperfusion period, active acupuncture treatment is performed for 20 minutes like above method.
16087454|NCT02255006|Drug|Celebrex 200mg|8 healthy volunteers are administered celecoxib, a selective COX-2 inhibitor, 200 mg twice daily for 5 days. Last dose of celecoxib is administered at morning. Volunteers undergo FMD measurements before and after ischemia reperfusion injury in that morning of last dose of celecoxib. During ischemia reperfusion period, active acupuncture treatment is performed for 20 minutes like above method
16087455|NCT02254993|Drug|C16G2|antimicrobial peptide
16087456|NCT02254980|Device|Vitamin-E diffused polyethylene acetabular component|Patients will undergo total hip arthroplasty using a cemented acetabular component diffused with Vitamin-E
16087457|NCT02254980|Device|Standard polyethylene acetabular component|Patients will undergo total hip arthroplasty using a standard cemented acetabular component
16087458|NCT02254967|Drug|Fidaxomicin|oral tablets administered in an extended pulsed regimen
16087459|NCT02254967|Drug|Vancomycin|oral capsule
16087460|NCT02254954|Drug|Macitentan in combination with RT and TMZ|Escalating doses of macitentan in combination with RT and TMZ, and maintenance TMZ.
16087461|NCT02254941|Drug|Chemotherapy|Metastatic colon cancer, first line treatment with conventional chemotherapy
16087462|NCT02254941|Biological|Chemotherapy plus monoclonal antibody|Metastatic colon cancer, first line treatment with conventional chemotherapy plus monoclonal antibody
16087463|NCT02254928|Drug|Corifollitropin alfa|One dose of 150 μg of corifollitropin alfa will be administered at day 1 of stimulation. Stimulation will be continued with 250-300 IU/day of rFSH from day 8 forward.
16087464|NCT02254915|Device|Synergo + MMC|Synergo radiofrequency (RF)-Induced hyperthermia-chemotherapy with mitomycin C (RITE). Intravesical instillation of MMC utilizing the Synergo system.
16087465|NCT02254915|Drug|Bacillus Calmette-Guérin|Intravesical instillation of BCG.
16087466|NCT02254902|Behavioral|Physical Activity intervention|The Physical Activity intervention is a 3-month group-based program based on an efficacious physical activity intervention that has been culturally adapted for use with adult Somali women. The program targets increased physical activity through educational and experiential opportunities.
16087467|NCT02254889|Drug|proton pump inhibitor|). In the pre-ESD therapeutic group, a standard intravenous dose of PPI was given 2 hours before ESD. In the post-ESD therapeutic group, patients also received intravenous PPI in standard doses, once in the evening after ESD.
16087468|NCT02254876|Other|Standard physical therapy program|Standard physical therapy program in this study involves joint health and passive mobility at the level of the shoulder girdle and upper limb affected by Painful Shoulder Syndrome associated with the modulation of hypertonic muscle groups.
16087469|NCT02254876|Other|NeuroMuscular Taping (NMT)|"The NeuroMuscular Taping (NMT) consists of the application on the skin of an adhesive tape with a particular structure to elastic waves and with characteristics comparable to those cutaneous. Because of these characterises it allows activation of endogenous analgesic, structural and muscular support, vascular and lymphatic activation.
~In this study the NMT is applied with decompressive mode on Pectoralis Major, Deltoids, Supraspinatus."
16087470|NCT02254863|Biological|DUOC-01|Intrathecal administration of DUOC-01
16087471|NCT02254850|Procedure|Flow Mediated Dilation|"Patients performed FMD by an high-resolution ultrasound linear probe in a supine decubitus and conditioned room.The probe was placed on humeral artery and connected to a mechanically arm. Then were performed several measurement s of the internal diameter of the vessel (edge to edge distance), on the R wave of the ECG, and software calculated the average value.The post-ischemic vasodilation was induced using a sphygmomanometer placed on the forearm, distal to the elbow crease, kept inflated to 250 mmHg for 5 minutes. The flow rate was recorded immediately after the desufflation; the diameter of the brachial artery was measured several times after desufflation (for 60-90 seconds). Nextly, the FMD was calculated as the percentage difference between the maximum diameter of the post-ischemic reached and the mean diameter of the vessel."
16087472|NCT02254850|Drug|Mesoglycan|The Patients firstly underwent to intramuscular administration of 1 vial only, containing: Mesoglycan 30mg/ml.
16087473|NCT02254850|Drug|Mesoglycan|The patients underwent to oral treatment with 1 capsule, administered bis in die for a period of 90 days, containing: Mesoglycan 50 mg.
16087474|NCT02254850|Drug|Placebo|The Patients firstly underwent to intramuscular administration only of 1 vial containing inactive ingredients: sodium chloride, chlorocresol, water for injections.
16087475|NCT02254850|Drug|Placebo|The patients underwent to oral treatment with 1 capsule, administered bis in die for a period of 90 days, containing inactive ingredients: lactose monohydrate, corn starch, croscarmellose sodium, magnesium stearate, gelatin, titanium dioxide, erythrosine.
16087476|NCT02254837|Device|Zilver PTX Drug-Eluting Stent|
16087477|NCT02254824|Drug|Xuezhikang|Xuezhikang
16087480|NCT02254811|Biological|Fecal Microbiota Transplant|transfer of healthy human gut bacteria to restore the microbiome
16087481|NCT02254798|Other|no intervention|this is a non interventional study
16087482|NCT02254785|Drug|cabazitaxel|Cabazitaxel 25mg/m2 intravenous every 3 weeks until disease progression
16087483|NCT02254785|Drug|Abiraterone|Abiraterone 1000mg daily (oral) until disease progression
16087484|NCT02254785|Drug|Enzalutamide 160mg daily (oral)|Enzalutamide 160mg daily (oral) until disease progression
16087485|NCT02254772|Biological|Ipilimumab|A dose of 10 mg in cohort 1 or 25mg in cohort 2 via intratumoral injection on day 2, week 1.
16087486|NCT02254772|Drug|SD-101|Started on day 2 week 1, then once every week x 4 successive weeks for a total of 5 injections.
16087487|NCT02254772|Radiation|Radiation therapy|Undergo low-dose radiation therapy to 1 site of disease
16087488|NCT02254759|Drug|Midazolam, IV|2 milligrams per milliliter (mg/mL) midazolam solution for IV administration. For a 1 mg dose, the midazolam solution (0.5 mL of 2 mg/mL) will be injected at 2 milligrams per minute (mg/min).
16087489|NCT02254759|Drug|Midazolam, oral|0.1 mg/mL midazolam for oral administration. For a 5 mg dose, participants will receive 50 mL of 0.1 mg/mL midazolam.
16087490|NCT02254759|Drug|RO5186582|RO5186582 120 mg film-coated release tablet.
16087491|NCT02254746|Radiation|Stereotactic Body Radiation Therapy (SBRT)|
16087492|NCT02254733|Behavioral|Cognitive Behavioral Social Skills Training (CBSST)|CBSST integrates CBT and SST techniques and neurocognitive compensatory aids. The treatment manual includes a patient workbook that describes the skills and includes homework assignment forms. Cognitive therapy is combined with role play practice of communication skills and problem-solving training. The ACT-adapted, team-delivered individual CBSST intervention will be delivered in 3 6-session modules (Cognitive Skills, Social Skills, and Problem Solving Skills) for a total of 18 weekly individual therapy sessions, but with participants completing the sequence of 3 modules twice, for a total of 36 sessions (9 months).
16087493|NCT02254733|Other|Assertive Community Treatment (ACT)|Assertive Community Treatment model is a evidence based practice model. ACT teams are multi-disciplinary and provide comprehensive services to individuals in their natural setting with small staff to recipient ratio. ACT teams use assertive engagement to proactively engage individuals in treatment providing services and support directly to individuals that are tailored to meet their specific goals and needs.
16087494|NCT02254720|Drug|BEA 2180 BR solution for infusion|
16087495|NCT02254720|Drug|Placebo|Intravenous infusion
16087496|NCT02254720|Drug|BEA 2180 BR solution for inhalation|
16087497|NCT02254720|Device|Respimat®|
16087498|NCT02254707|Drug|BILB 1941 ZW|
16087499|NCT02254707|Drug|Placebo|
16087500|NCT02254694|Other|high heeled shoes|see detailed study description
16087501|NCT02254681|Drug|Gemcitabine|
16087502|NCT02254681|Drug|Cisplatin|
16087503|NCT02254681|Radiation|low dose radiotherapy|Whole liver and portal lymph node basin low dose radiotherapy
16087504|NCT02254668|Other|Protocol with Everolimus (Certican®)|Electronic (computer-assisted) randomization of an immunosuppressive protocol WITH Everolimus (Certican®).
16087505|NCT02254668|Other|Protocol with Mycophenolate mofetil (CellCept®)|Electronic (computer-assisted) randomization of an immunosuppressive protocol WITHOUT Everolimus (Certican®), instead administration of Mycophenolate mofetil (CellCept®).
16087506|NCT02254655|Drug|Puerarin injection 400 mg|Patients receive treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, statins, bone metabolism regulators and gastric mucosal protective agents on as-needed basis.Furthermore, patients were administrated with 400 mg intravenously infused puerarin injection once a day.Each treatment course lasted for 2 weeks followed by a regular time interval of 15 days.
16087507|NCT02254655|Drug|Control|Patients receive treatment with oral anti-rheumatic agents and/or non-steroidal anti-inflammatory drugs, prednisone, aspirin, statins, bone metabolism regulators and gastric mucosal protective agents on as-needed basis
16087508|NCT02254642|Procedure|Ischemic preconditioning during aortic clamping|Ischemic preconditioning during aortic clamping
16087509|NCT02254642|Procedure|Procedure/Surgery: usual surgery|Procedure/Surgery: usual surgery
16087510|NCT02254629|Drug|Probiotic Clostridium Butyricum|probiotic:2 tablets/ times, 3 times / day for 2 weeks
16087511|NCT02254629|Drug|Laxative Polyethylene Glycol|laxative：2000 ml.
16087512|NCT02254616|Behavioral|Mirror Therapy with tDCS|The MTtDCS group will receive a 20-minute tDCS at 1.5 mA current intensity per session followed by a 40-minute mirror therapy and 30-minute functional training during the first two weeks. Sixty-minute pure mirror therapy during the last 2 weeks, and followed by a 30-minute functional training.
16087513|NCT02254616|Behavioral|Mirror Therapy with sham-tDCS|The MTtDCS(m) group will receive a 20-minute sham-tDCS per session followed by a 40-minute mirror therapy and 30-minute functional training during the first two weeks. Sixty-minute pure mirror therapy during the last 2 weeks, and followed by a 30-minute functional training.
16087514|NCT02254616|Behavioral|Mirror Therapy|The MT group will receive a 60-minute MT per session followed by a 30-minute functional training.
16087515|NCT02254616|Behavioral|Control Intervention|The CI group will receive a 60-minute conventional stroke rehabilitation training followed by a 30-minute functional training.
16087516|NCT02254603|Device|Acupuncture|Acupuncture about 30 mins will be performed by a traditional Chinese physician three times a week for 3 months.
16087517|NCT02254603|Behavioral|Yoga exercise|Subject will receive regular 60-minutes yoga exercise three times a week for 3 months.
16087518|NCT02254590|Procedure|Irrigation Endoscopic Decompressive Laminotomy|2 portals 0.5cm were used one for the endoscope and the other for instruments. For every additional level one portal is added. The endoscope and instruments are directly placed over the surface of lamina without any dissection and saline under pump pressure is used to open a potential working space. Unilateral laminotomy/laminectomy is performed according to the severity of stenosis, followed by bilateral decompression beneath the midline structures.
16087519|NCT02254577|Drug|Endometrin® plus Progesterone in Oil (PIO)|
16087520|NCT02254577|Drug|Progesterone in Oil (PIO) Only|
16087571|NCT02254226|Drug|Salmeterol MDI low|
16087572|NCT02254226|Drug|Salmeterol MDI high|
16087573|NCT02254213|Other|EEG recording|A short EEG recording is performed 10 times over the span of three months.
16087521|NCT02254551|Drug|LDE225|"Lead-In: LDE225 will be administered orally at three dose levels starting at 400mg. If acceptable tolerability is demonstrated, escalations may continue up to 800 mg. LDE225 will be administered orally as a single daily dose for 21 days in combination with a fixed dose of bortezomib to be given on Days 1, 4, 8, 11 of each 21 day cycle.
~Dose Expansion: LDE225 will be given as a single oral daily dose for 21 days at the MTD determined in the lead-in phase.
~Maintenance Therapy: Patients who complete 16 cycles of therapy with stable disease or better will be eligible for single agent maintenance therapy of LDE225 at the MTD orally for up to 2 years or until progressive disease or unacceptable toxicity."
16087522|NCT02254551|Drug|Bortezomib|In both the lead-in and dose expansion portions of the study, bortezomib, 1.3 mg/m2, will be administered by subcutaneous injection (SQ) on Days 1, 4, 8, 11 of each 21 day cycle.
16087523|NCT02254538|Drug|BILR 355 BS|
16087524|NCT02254538|Drug|PEG 400|
16087525|NCT02254525|Drug|Intravenous ibuprofen|"Treatment group: 800 mg IV ibuprofen, starting at the moment of skin closure and every 6 hours up to 72 hours after the first dose.
~All patients will receive morphine administered by patient controlled analgesia (PCA). Investigation treatment will be administered every 6 hours until 24 h in abdominal surgery, 48 h in hip surgery and 72 h in knee surgery."
16087526|NCT02254525|Drug|Saline solution|"Placebo group: 200 ml of saline solution, starting at the moment of skin closure and every 6 hours up to 72 hours after the first dose.
~All patients will receive morphine administered by patient controlled analgesia (PCA). Investigation treatment will be administered every 6 hours until 24 h in abdominal surgery, 48 h in hip surgery and 72 h in knee surgery."
16087527|NCT02254486|Drug|NER1006|The subject will self-administer the first dose of the assigned investigational product in the evening prior to the scheduled colonoscopy and take mandatory additional clear fluid. Subject will take the second dose together with mandatory additional clear fluids on the morning of the colonoscopy.
16087528|NCT02254486|Drug|Trisulfate solution|The subject will self-administer the first dose of the assigned investigational product in the evening prior to the scheduled colonoscopy and take mandatory additional clear fluid. Subject will take the second dose together with mandatory additional clear fluids on the morning of the colonoscopy.
16087529|NCT02254473|Other|Wedge Insert|
16087530|NCT02254473|Other|Flat Insert|
16087531|NCT02254460|Dietary Supplement|Test|Experimental product: Micronutrient fortified beverage powder, packed as 27 g individual sachet, administered orally as a single serve.
16087532|NCT02254460|Other|Control|Energy equivalent beverage powder without micronutrient fortification, packed as 27 g individual sachets, administered orally as a single serve
16087533|NCT02254447|Drug|Candesartan Cilexetil in formulation 1|Round, biconvex white tablets containing Candesartan cilexetil 16 mg for oral administration
16087534|NCT02254447|Drug|Candesartan Cilexetil in formulation 2|Round, biconvex white tablets containing Candesartan cilexetil 16 mg for oral administration
16087535|NCT02254447|Drug|ATACAND|Round, biconvex pink tablets containing Candesartan cilexetil 16 mg for oral administration
16087536|NCT02254434|Drug|Eltrombopag|Eltrombopag 50 mg per tablet for oral route of administration will be sourced locally
16087537|NCT02254421|Drug|Presatovir|Presatovir 200 mg (4 × 50 mg tablets) administered orally or via nasogastric (NG) tube
16087538|NCT02254421|Drug|Placebo|Placebo to match presatovir administered orally or via nasogastric tube
16087539|NCT02254408|Drug|Presatovir|Presatovir 200 mg (4 × 50 mg tablets) administered orally or via nasogastric (NG) tube
16087540|NCT02254408|Drug|Placebo|Tablets administered orally or via nasogastric tube
16087541|NCT02254395|Device|Deep Brain Stimulation|
16087542|NCT02254382|Device|Adaptive servo ventilation (ASV)|Non-invasive Ventilation used to control central and obstructive sleep apnea.
16087543|NCT02254369|Drug|GC021109|
16087544|NCT02254369|Other|Placebo|
16087545|NCT02254356|Device|Zilver Flex Bare Metal Stent|
16087546|NCT02254343|Device|proximal robot-assisted therapy|
16087547|NCT02254343|Device|distal robot-assisted therapy|
16087548|NCT02254343|Behavioral|individualized intensive therapy|
16087549|NCT02254317|Dietary Supplement|0 mg placebo|Not containing GSE (Placebo)
16087550|NCT02254317|Dietary Supplement|300 mg GSE|300 mg GSE
16087551|NCT02254317|Dietary Supplement|600 mg GSE|Containing 600 mg of GSE
16087552|NCT02254317|Dietary Supplement|900 mg GSE|Containing 900 mg of GSE
16087553|NCT02254304|Drug|Rebif|Rebif will be administered at a dose of 44 microgram (mcg) subcutaneously using RebiSmart auto-injector three times a week for a total duration up to 12 months.
16087554|NCT02254291|Drug|semaglutide|Once weekly doses of 0.5 mg semaglutide after an initial dose escalation step of 0.25 mg (4 weeks). Total duration of treatment is 30 weeks. Administered subcutaneously (s.c. under the skin).
16087555|NCT02254291|Drug|semaglutide|Once weekly doses of 1.0 mg semaglutide after an initial dose escalation step of 0.25 mg (4 weeks) followed by 0.5 mg for 4 weeks. Total duration of treatment is 30 weeks. Administered subcutaneously (s.c. under the skin).
16087556|NCT02254291|Drug|sitagliptin|Daily doses of 100 mg sitagliptin. Total duration of treatment is 30 weeks. Administered as oral tablets.
16087560|NCT02254265|Drug|OTX-101 0.05%|OTX-101 0.05% Ophthalmic Solution
16087561|NCT02254265|Drug|OTX-101 0.09%|OTX-101 0.09% Ophthalmic Solution
16087562|NCT02254265|Drug|Vehicle|Vehicle of OTX-101 Ophthalmic Solution
16087563|NCT02254252|Drug|Nicorandil|nicorandil (10mg tablets, two times a day)
16087564|NCT02254252|Drug|Nitroglycerin|sustained-release glyceryl trinitrate (6.4mg tablets, two times a day)
16087565|NCT02254239|Drug|Brentuximab Vedotin|Given IV
16087566|NCT02254239|Drug|Everolimus|Given PO
16087567|NCT02254239|Other|Laboratory Biomarker Analysis|Correlative studies
16087568|NCT02254239|Other|Pharmacological Study|Correlative studies
16087569|NCT02254226|Drug|Salmeterol Diskus low|
16087671|NCT02253797|Drug|14C-Tipranavir|
16087574|NCT02254200|Other|Fatmax group|For the Fatmax group each session will consist of 40-50 min of continuous exercise with an intensity that corresponded to the individual Fatmax (moderate intensity)
16087575|NCT02254200|Other|HIIT group|For HIIT group, each session will consist of 10x60-s cycling intervals interspersed with 60-s of recovery. The workloads will be selected to elicit a heart rate of ~90% maximal heart rate during the intervals with a pedal rate of 90-100 revolutions.min-1, whereas during recovery, the participants will be allowed to pedal against a resistance of 50 W
16087576|NCT02254187|Drug|Salmeterol capsule - low|
16087577|NCT02254187|Drug|Salmeterol capsule - high|
16087578|NCT02254187|Drug|Salmeterol via Serevent® Diskus®|
16087579|NCT02254174|Drug|Tiotropium/Salmeterol|Fixed dose combination of tiotropium 7.5 μg and salmeterol 25 μg inhalation powder, PE capsule via HandiHaler®
16087580|NCT02254174|Drug|Serevent® Diskus®|
16087581|NCT02254174|Drug|Spiriva®|
16087582|NCT02254161|Drug|Matching placebo|Tablet
16087583|NCT02254161|Drug|BI 1181181 healthy elderly|Tablet
16087584|NCT02254161|Drug|BI 1181181 Healthy young|Tablet
16087585|NCT02254148|Drug|midazolam|single dose of midazolam given as oral solution (day 1 of visits 2 and 3)
16087586|NCT02254148|Drug|caffeine|single dose of caffeine given as tablets (day 1 of visits 2 and 3)
16087587|NCT02254148|Drug|digoxin|single dose of digoxin given as tablets (day 3 of visits 2 and 3)
16087588|NCT02254148|Drug|warfarin|single dose of warfarin given as tablets (day 1 of visits 2 and 3)
16087589|NCT02254148|Drug|omeprazole|single dose of omeprazole given as tablet (day 1 of visits 2 and 3)
16087590|NCT02254148|Drug|BI 187004|multiple doses of BI 187004 given as tablets (day 7-12 of visit 2 and day 1-6 of visit 3)
16087591|NCT02254148|Drug|metoprolol|single dose of metoprolol given as tablets (day 1 of visits 2 and 3)
16087592|NCT02254135|Drug|BEA 2180 BR - rising dose|
16087593|NCT02254135|Drug|Placebo|
16087594|NCT02254122|Drug|BEA 2180 BR|
16087595|NCT02254122|Drug|Placebo|
16087596|NCT02254122|Device|Respimat®|
16087597|NCT02254109|Drug|BEA 2180 BR - rising dose|
16087598|NCT02254109|Drug|Placebo|
16087599|NCT02254096|Drug|BIRT 1696 BS|
16087600|NCT02254096|Drug|Placebo|
16087601|NCT02254096|Other|Grapefruit juice (GFJ)|
16087602|NCT02254096|Other|High fat meal (HFM)|
16087603|NCT02254083|Drug|BIBT 986 BS - low|
16087604|NCT02254083|Drug|BIBT 986 BS - high|
16087605|NCT02254083|Drug|Placebo|
16087606|NCT02254070|Drug|BIBT 986 BS|
16087607|NCT02254057|Drug|BIBT 986 BS - single rising dose|
16087608|NCT02254057|Drug|Placebo|
16087609|NCT02254044|Drug|bivatuzumab mertansine|
16087610|NCT02254031|Drug|bivatuzumab mertansine|
16087611|NCT02254018|Drug|bivatuzumab mertansine|
16087612|NCT02254005|Drug|bivatuzumab mertansine|
16087613|NCT02253992|Biological|Urelumab|
16087614|NCT02253992|Biological|Nivolumab|
16087615|NCT02253979|Device|Standard double lumen tube|Endotracheal left side double lumen tube
16087616|NCT02253979|Device|VivaSight double lumen tube|VivaSight double lumen endotracheal intubation
16087617|NCT02253966|Drug|Methylprednisoloneacetate|
16087618|NCT02253966|Drug|Lidocaine|
16087619|NCT02253966|Other|sodium chloride|
16087620|NCT02253953|Drug|BILR 355 BS, D1|
16087621|NCT02253953|Drug|BILR 355 BS, D2|
16087622|NCT02253953|Drug|BILR 355 BS, D3|
16087623|NCT02253953|Drug|BILR 355 BS, D4|
16087624|NCT02253953|Drug|BILR 355 BS, D5|
16087625|NCT02253953|Drug|BILR 355 BS, D6|
16087626|NCT02253953|Drug|BILR 355 BS, D7|
16087627|NCT02253953|Drug|BILR 355 BS, D8|
16087628|NCT02253953|Drug|BILR 355 BS, D10|
16087629|NCT02253953|Drug|Placebo|
16087630|NCT02253953|Other|high-fat breakfast|
16087631|NCT02253953|Drug|Ritonavir|
16087632|NCT02253940|Drug|BILR 355 - Treatment A (current tablet formulation)|
16087633|NCT02253940|Drug|BILR 355 - Treatment B (new tablet formulation)|
16087634|NCT02253940|Drug|BILR 355 - Treatment C (new capsule formulation)|
16087635|NCT02253940|Drug|BILR 355 - Treatment D (current tablet formulation)|
16087636|NCT02253940|Drug|BILR 355 - Treatment E (new capsule formulation)|
16087637|NCT02253940|Drug|Ritonavir|
16087638|NCT02253927|Drug|BILR 355 - D1|
16087639|NCT02253927|Drug|BILR 355 - D2|
16087640|NCT02253927|Drug|BILR 355 - D3|
16087641|NCT02253927|Drug|BILR 355 - D4|
16087642|NCT02253927|Drug|Ritonavir|
16087643|NCT02253927|Other|high fat breakfast|
16087644|NCT02253914|Drug|BILR 355 BS, solution|
16087645|NCT02253914|Drug|BILR 355 BS, tablet|
16087646|NCT02253914|Drug|Ritonavir|
16087647|NCT02253914|Drug|Placebo|
16087648|NCT02253901|Drug|BILR 355 BS|
16087649|NCT02253901|Drug|Ritonavir|
16087650|NCT02253901|Drug|TRUVADA|
16087651|NCT02253888|Drug|TPV - Room condition|
16087652|NCT02253888|Drug|TPV - Refrigerated conditions|
16087653|NCT02253888|Drug|Ritonavir (RTV)|
16087654|NCT02253875|Drug|Tipranavir (TPV)|
16087655|NCT02253875|Drug|Ritonavir|
16087656|NCT02253875|Drug|Omeprazole|
16087657|NCT02253862|Drug|Tadalafil|administered days 1, 8 and 16
16087658|NCT02253862|Drug|Tipranavir|administered days 8-18
16087659|NCT02253862|Drug|Ritonavir|administered days 8-18
16087660|NCT02253849|Drug|Carbamazepine|
16087661|NCT02253849|Drug|Tipranavir|
16087662|NCT02253849|Drug|Ritonavir|
16087663|NCT02253836|Drug|Tipranavir|TPV
16087664|NCT02253836|Drug|Ritonavir|RTV
16087665|NCT02253836|Drug|Atazanavir|TAZ
16087666|NCT02253823|Drug|EFV|
16087667|NCT02253823|Drug|TPV/RTV - low dose|
16087668|NCT02253823|Drug|TPV/RTV - high dose|
16087669|NCT02253810|Drug|Tranexamic Acid|
16087670|NCT02253810|Drug|Placebo|
16087676|NCT02253771|Device|shockwave therapy|Shockwave therapy with 2000 impulses/treatment at 12 Hz; 8 treatment over 4 weeks, twice a week
16087677|NCT02253771|Device|placebo shockwave therapy|sham shockwave therapy by an identically looking device without any function
16087678|NCT02253758|Drug|Propofol|Propofol will be injected as a continuous infusion by TCI intravenously
16087679|NCT02253745|Drug|V81444|V81444 capsules for oral administration, 100 mg twice daily for 13 days and once on Day 14
16087680|NCT02253745|Drug|Placebo|Capsules to match V81444 twice daily for 13 days and once on Day 14
16087681|NCT02253732|Behavioral|3 months exercise intervention program|3 months exercise intervention program which is given 3-times per week, 60 min session duration, 65-75% repetition maximum or heart rate maximum, combined strength & aerobic exercises
16087682|NCT02253719|Procedure|cryotherapy, further biopsy, LEEP, surgery as indicated|These interventions and their outcomes are not part of this study. However, we will be offering at no charge appropriate treatment for neoplasia or cancer that is diagnosed.
16087683|NCT02253706|Device|High flow nasal oxygen supplementation|High-flow nasal ventilation: This will be carried out using the Precision Flow device (Opti-Flow, Auckland, New Zealand). This device is intended to add warm moisture to breathing gases from an external source. Flow rate via the nasal cannula will be kept at 50 Liters/min and fractional inspired oxygen concentration will be set at 0.35.
16087684|NCT02253706|Device|low flow nasal oxygen supplementation|Low-flow nasal ventilation: This will be carried out using a regular nasal cannula fed with oxygen at flow rates from 2 to 6 liters/minute.
16087685|NCT02253680|Procedure|Actico, short-stretch, inelastic dressing|Worn 24hr post-operatively
16087686|NCT02253667|Device|HFONC|
16087687|NCT02253667|Device|Conventional oxygen therapy|
16087688|NCT02253654|Drug|Epoetin alfa|Administered intravenously (IV) three times a week (TIW) by appropriately trained healthcare professionals during hemodialysis.
16087689|NCT02253641|Behavioral|Standard Weight Loss Intervention|14-session/6-month standard behavioral weight loss intervention
16087690|NCT02253641|Behavioral|Stress-Focused Weight Loss Intervention|14-session/6-month tailored behavioral weight loss intervention
16087691|NCT02253628|Other|Cold espresso|Volunteers consumed cold espresso with 160 mg caffeine. Salivary gastrin, alpha-amylase and cortisol and self-reported GI symptoms and stress were collected at fasting and postprandially.
16087692|NCT02253628|Other|Hot instant coffee|Volunteers consumed hot instant coffee with 160 mg caffeine. Salivary gastrin, alpha-amylase and cortisol and self-reported GI symptoms and stress were collected at fasting and postprandially.
16087693|NCT02253628|Other|Cold instant coffee|Volunteers consumed cold instant coffee with 160 mg caffeine. Salivary gastrin, alpha-amylase and cortisol and self-reported GI symptoms and stress were collected at fasting and postprandially.
16087694|NCT02253628|Other|Hot filter coffee|Volunteers consumed hot filter coffee with 160 mg caffeine. Salivary gastrin, alpha-amylase and cortisol and self-reported GI symptoms and stress were collected at fasting and postprandially.
16087695|NCT02253615|Other|Machines exercises|Resistance training in pneumatic machines.
16087696|NCT02253615|Other|Elastic exercises|Resistance training with elastic tubes.
16087697|NCT02253602|Drug|Ferumoxytol|maximum rate of administration 1 ml/sec
16087698|NCT02253589|Behavioral|modified ASSIST-linked Brief Intervention|Trained counsellors support participant's motivation to reduce or stop khat use in a 20 minute counselling session.
16087699|NCT02253576|Other|inhaled 7% hypertonic saline|Three consecutive doses of 4 ml of 7% hypertonic saline added to salbutamol, 0.15 mg/kg; 0.03 ml/kg of 0.5% salbutamol nebulizer solution over 1 hour
16087700|NCT02253576|Other|inhaled nebulized normal saline|Three consecutive doses of 4 ml of 0.9% NaCl added to salbutamol, 0.15 mg/kg; 0.03 ml/kg of 0.5% salbutamol nebulizer solution over 1 hour
16087701|NCT02253563|Behavioral|Resistance Training|
16087702|NCT02253563|Behavioral|Balance Training|
16087703|NCT02253550|Drug|Simeprevir|Simeprevir is a Hepatitis C Virus (HCV) NS3/4A protease inhibitor approved in the United States, Canada and Japan for the treatment of chronic HCV infection.
16087704|NCT02253550|Drug|Sofosbuvir|Sofosbuvir is a nucleotide NS5B polymerase inhibitor developed by Gilead Sciences Inc. and approved for the treatment of chronic HCV infection.
16087705|NCT02253537|Device|CST001|
16087706|NCT02253524|Drug|Dimenhydrinate|50 mg Dramamine with 5 cc syringe in 150 ml normal saline given as a slow intravenous infusion over 15 minutes
16087707|NCT02253524|Drug|Metoclopramide|10 mg Metoclopramide with 5 cc syringe in 150 ml normal saline given as a slow intravenous infusion over 15 minutes
16087708|NCT02253511|Drug|Cidan capsule|
16087709|NCT02253498|Device|deep brain stimulation (DBS)|
16087710|NCT02253485|Drug|telbivudine|"in telbivudine treatment entire pregnancy group, mothers were treated with telbivudine during entire pregnancy for hepatitis B.
~in telbivudine treatment in late pregnancy group, mothers with high serum HBV DNA load receive telbivudine treatment in late pregnancy for preventing MTCT of HBV."
16087711|NCT02253472|Device|Deep Brain Stimulation|
16087712|NCT02253459|Drug|UTD1 Injection plus capecitabine|
16087713|NCT02253459|Drug|Capecitabine|
16087714|NCT02253446|Drug|Piroxicam|20 mg of piroxicam (Feldene ampoule-Pfizer-France) intramuscularly (IM) was given 200 patients,
16087715|NCT02253446|Drug|Diclofenac Sodium|Second Group: Diclofenac sodium 75mg (Miyadren ampoule-bulb-Yavuz Istanbul) intramuscularly (IM) was given 200 patients.
16087716|NCT02253433|Other|Enhanced Clinic Care|The intervention includes a standard clinical appointment including spirometry, as well as collection of self-report information from detailed health and exposure questionnaires, asthma education, assessment for allergies, and a customized asthma self-management plan developed using motivational interviewing.
16087717|NCT02253433|Other|Enhanced Clinic Care + Home Intervention|The home-based component includes environmental exposure assessment (observed and measured) and a multicomponent exposure reduction and asthma control intervention (five home visits over approximately 12 months).
16087718|NCT02253420|Drug|Copanlisib (BAY80-6946)|"Part 1 of Cycle 1 Cycle 1 Day 1: Single i.v. dose 12mg Cycle 1 Day 15: Single i.v. dose 12 mg Part 2 of Cycle 1 Cycle 1 Day 1: Single i.v. dose 60mg (based on Part 1 data) Cycle 1 Day 15: Single i.v. dose 60mg (based on Part 1 data)
~Part 1 & Part 2
~Cycle 2 and subsequent cycles:
~Day 1: Single i.v. dose of 60mg Day 8: Single i.v. dose of 60mg Day15: Single i.v. dose of 60mg"
16087719|NCT02253420|Drug|Itraconazole|Cycle 1 Day 12: 2 x 200 mg itraconazole oral (two doses, 12 hours apart) Cycle 1 Days 13-21: 200 mg itraconazole oral, once daily in the morning
16087720|NCT02253420|Drug|Rifampin|Cycle 1 Days 10 - 21: 600mg Rifampin oral, once daily in the morning
16087721|NCT02253420|Drug|Copanlisib (BAY80-6946)|"Cycle 1 Day 1: Single i.v. dose 60mg Cycle 1 Day 15: Single i.v. dose 60mg
~Cycle 2 and subsequent cycles:
~Day 1: Single i.v. dose of 60mg Day 8: Single i.v. dose of 60mg Day15: Single i.v. dose of 60mg"
16087722|NCT02253407|Biological|MMR vaccine|
16087723|NCT02253394|Drug|Ambrisentan plus Spironolactone|Cardiopulmonary fitness
16087724|NCT02253394|Drug|Ambrisentan plus Placebo|Placebo is a sugar pill manufactured to resemble spironolactone 50 mg Cardiopulmonary fitness
16087725|NCT02253381|Procedure|Right|Right lateral decubitus position during spinal anesthesia
16087726|NCT02253381|Procedure|Left|Left lateral decubitus position during spinal anesthesia
16087727|NCT02253368|Other|sleep|
16087728|NCT02253355|Device|Deep Brain Stimulation|
16087729|NCT02253342|Drug|WCK-2349|Each subject will receive ten oral doses of 1000 mg WCK 2349 administered twice-daily starting on Day 1
16087730|NCT02253329|Procedure|Dietary protein plus NMES during the day|Neuromuscular electrical stimulation after a protein bolus, performed during the day
16087731|NCT02253329|Procedure|Dietary protein plus NMES prior to sleep|Neuromuscular electrical stimulation after a protein bolus, performed prior to sleep
16087732|NCT02253316|Biological|Ixazomib|
16087733|NCT02253316|Drug|Lenalidomide|
16087734|NCT02253316|Drug|Dexamethasone|
16087735|NCT02253303|Other|midline incision or off-midline incision|Eligible patients are randomized to midline incision or off-midline incision group in laparoscopic colectomy
16087736|NCT02253277|Drug|Nilotinib|Nilotinib was supplied by Novartis as 150 mg and 200 mg hard gelatin capsules. Nilotinib was not dosed by weight or body surface area. Medication labels were in German and complied with the legal requirements of Germany. They included storage conditions for the drug but no information about the patient. The investigator emphasized compliance and instructed the patient to take nilotinib exactly as prescribed.
16087737|NCT02253277|Drug|Ruxolitinib|Ruxolitinib was supplied by Novartis as 5 mg, 15 mg, and 20 mg tablets. Medication labels were in German and complied with the legal requirements of Germany. They included storage conditions for the drug but no information about the patient. The investigator emphasized compliance and instructed the patient to take ruxolitinib exactly as prescribed.
16087738|NCT02253264|Drug|Rituximab|
16087739|NCT02253251|Genetic|KRAS-variant and microRNA binding site mutation testing|Participant in these studies will be tested for the KRAS-variant
16087740|NCT02253238|Behavioral|Quality of Life Survey|Quality of life survey completed at baseline, 7 days after radiation therapy (RT) and at 6 - 8 weeks after RT.
16087741|NCT02253238|Behavioral|Health Management Surveys|Confidence in health management survey; completed at baseline and 6 - 8 weeks after RT.
16087742|NCT02253238|Other|Monitoring Devices|Home use of CYCORE devices (blood pressure monitor, weight scale, electronic tablet, palm-sized plug-in computer)
16087743|NCT02253238|Behavioral|Symptoms Surveys|"Behavioral: Symptoms survey 1; completed at weeks 1, 3, 5, and 7 days after RT, and at 6 - 8 weeks after RT.
~Behaviorial: Symptoms survey 2; completed at baseline, weeks 1, 3, 5, and 7 days after RT, and at 6 - 8 weeks after RT."
16087744|NCT02253238|Behavioral|Device Usability Survey|Device usability survey; completed at weeks 1, 3, 5, and 7 days after RT.
16087745|NCT02253225|Other|Functional Magnetic Resonance Imaging (fMRI)|Imaging will be performed on a 3T Siemens Trio scanner. Each MRI scanning session will last no more than 90 minutes.
16087746|NCT02253212|Device|SonoCloud|SonoCloud : dose escalation
16087747|NCT02253212|Drug|Carboplatin|Carboplatin : min 6 cycles - individual dose determination according to renal function and AUC
16087748|NCT02253199|Drug|intranasal dexmedetomidine|"Children who were not adequately sedated ( no evidence of adequate sedation within 30 min after administration of Initial dose of chloral hydrate) received a bolus of intranasal dexmedetomidine which adjusted by the Dixon up-and-down method for rescue sedation.
~The first child received 0.8mcg/Kg of intranasal dexmedetomidine dose (100mcg/ml), and the dose interval was set at 0.1mcg/Kg."
16087749|NCT02253186|Device|Auto-Adjustable MOBIDERM Armsleeve|
16087750|NCT02253173|Drug|Estradiol|
16087751|NCT02253173|Drug|Placebo|
16087752|NCT02253160|Device|Spectra Optia CMNC|The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood.
16087753|NCT02253160|Device|COBE Spectra MNC|It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled.
16087754|NCT02253160|Drug|Granulocyte-colony stimulating factor (G-CSF)|Each subject received an injection of the G-CSF approximately equivalent to 10 ug/kg body weight subcutaneous per day for 5 days prior to the MNC collection procedure.
16087755|NCT02253147|Device|TEOSYAL® RHA Ultra Deep|"A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 27Gauge ½ disposable sterile needles."
16087756|NCT02253121|Drug|Dapagliflozin|Dapagliflozin 10mg during glucocorticoid therapy for acute exacerbation COPD
16087757|NCT02253121|Drug|Sliding scale insulin|Sliding scale insulin with short acting insulin based on current glucose levels
16087758|NCT02253108|Device|Everolimus eluting bioresorbable polymer stent|
16087759|NCT02253108|Device|Biolimus eluting bioresorbable polymer stent|
16087760|NCT02253095|Drug|Albendazole|
16087761|NCT02253095|Dietary Supplement|Zinc|
16087762|NCT02253095|Dietary Supplement|Multiple Micronutrient Supplement|
16087763|NCT02253095|Drug|Placebo|
16088075|NCT02251132|Drug|Radiolabelled erythromycin|
16087764|NCT02253082|Drug|OctaplasLG®|OctaplasLG® is an industrial donor plasma product pooled from approximately 400 single donor units. It possess' unique features when compared to standard FFP, such as having standardized concentrations of natural pro- and anti-coagulation factors, standardized volume and as being pathogen free. Very importantly, the manufacturing method of OctaplasLG® removes immune complexes and cells in several steps of microfiltration in addition to viral, bacterial and prion pathogen inactivation.
16087765|NCT02253082|Biological|Fresh frozen plasma|Standard FFP from the Blood Bank
16087766|NCT02253069|Device|Applying Prontosan antiseptic solution to tie-over dressings|Applying a PHMB-based antiseptic to tie-over dressings
16087767|NCT02253069|Device|Applying Placebo to tie-over dressings|Placebo control
16087768|NCT02253056|Other|Fasting / Caloric Restriction|
16087769|NCT02253056|Other|Healthy Diet|
16087770|NCT02253043|Device|Deep Brain Stimulation (Beijing PINS Medical Co., Ltd)|PINS Stimulator System
16087771|NCT02253030|Device|Optical Coherence Tomography|
16087772|NCT02253017|Other|Children operated on for cataract|Compilation of results of monitoring of children aged 8 to 10 months, 3 years, 5 years, 8 years
16087773|NCT02253004|Drug|Cilostazol|Single oral administration of active or placebo one week apart
16087774|NCT02253004|Drug|Placebo|
16087775|NCT02252991|Other|physical activity|Patients will realise physical activity either during their treatment, either after their treatment. They will have practise a physical activity three times per week.
16087776|NCT02252978|Drug|ciprofloxacin|Given PO
16087777|NCT02252978|Other|placebo|Given PO
16087778|NCT02252978|Other|quality-of-life assessment|Ancillary studies
16087779|NCT02252978|Other|laboratory biomarker analysis|Correlative studies
16087780|NCT02252965|Drug|Metformin IR|Subjects will receive Metformin Immediate Release (IR) tablets, orally once daily at a dose of 500 milligram (mg) for 1 week, and then dose will increase with increments of 500 mg every week in first 2 weeks to 1500 mg. After that dose will increase up to maximum dose of 2000 mg for the next 2 weeks and will be maintained at 2000 mg until Week 16.
16087781|NCT02252965|Drug|Metformin XR|Subjects will receive Metformin Extended Release (XR) tablets, orally once daily at a dose of 500 mg for 1 week, and then dose will increase with increments of 500 mg every week in first 2 weeks to 1500 mg. After that dose will increase up to maximum dose of 2000 mg for the next 2 weeks and will be maintained at 2000 mg until Week 16.
16087782|NCT02252952|Other|Beverage Consumption|
16087783|NCT02252939|Radiation|X-Ray|X-ray as part of standard care
16087784|NCT02252926|Drug|Bupivacaine|25 mg bupivacaine lozenge
16087785|NCT02252926|Drug|Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin)|Standard treatment includes lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin
16087786|NCT02252913|Drug|Volitinib|oral administration
16087787|NCT02252913|Drug|Docetaxel|intravenous injection
16087788|NCT02252900|Other|Magnetic resonance imaging|All patients will undergo the diagnostic test specific to the study
16087789|NCT02252887|Drug|Gemcitabine|
16087790|NCT02252887|Drug|Trastuzumab|
16087791|NCT02252887|Drug|Pertuzumab|
16087792|NCT02252874|Behavioral|Slow-paced action video game|20 hours slow-paced action video games
16087793|NCT02252874|Behavioral|Fast-paced action video game|20 hours fast-paced action video games
16087794|NCT02252874|Behavioral|Control|20 hours leisure activities
16087795|NCT02252861|Other|Percutaneous Left Atrial Appendage Closure in routine care|The inclusion in the database induces no specific intervention. Percutaneous Left Atrial Appendage Closure is performed for patient care. No specific intervention is performed specifically for the database. Neither left atrial appendage closure procedure nor patient follow up are modified by patient inclusion in the database.
16087796|NCT02252835|Drug|Arhalofenate|800 mg once daily orally for four weeks
16087797|NCT02252835|Drug|Febuxostat|40 mg once daily orally for 1 week then up-titrated to 80 mg once daily orally for another three weeks
16087798|NCT02252835|Drug|Arhalofenate|600 mg once daily orally for four weeks
16087799|NCT02252835|Drug|Febuxostat|80 mg once daily orally for 1 week then down-titrated to 40 mg once daily orally for another three weeks
16087800|NCT02252835|Drug|Colchicine|0.6 mg daily
16087801|NCT02252822|Behavioral|Overcoming Bulimia Online Programme|
16087802|NCT02252809|Drug|adalimumab|
16087803|NCT02252809|Drug|methylprednisolone|
16087804|NCT02252796|Radiation|Hypofractionated Stereotactic Boost|An ablative dose of radiation is delivered to the primary tumor target over a week through Stereotactic Ablative Radiotherapy.
16087805|NCT02252796|Drug|Carboplatin|Given during chemo-radiation phase and optional consolidative phase.
16087806|NCT02252796|Drug|Paclitaxel|Given during chemo-radiation phase and optional consolidative phase.
16087807|NCT02252796|Radiation|Image-guided IMRT|Given during chemo-radiation phase
16087808|NCT02252783|Drug|BFPET|Sterile study drug will be delivered in individual dosage vials labeled and calibrated to approximately 2 mCi (74MBq) for the rest imaging and up to 8 mCi (296 MBq) for the stress imaging at the time of injection. The drug will be administered intravenously by bolus injection over 10 seconds into a peripheral vein to which access has been secured followed by saline flush.
16087809|NCT02252770|Dietary Supplement|Nitric oxide supplement|Each active comparator supplement is an all natural nitric oxide supplement. Subjects will take one lozenge twice a day.
16087810|NCT02252770|Dietary Supplement|Placebo|Placebo will not contain nitric oxide supplement.
16087811|NCT02252757|Device|CoVa|
16087812|NCT02252744|Other|No intervention|
16087813|NCT02252731|Drug|Warfarin|Oral
16087814|NCT02252731|Drug|FG-4592|Oral
16087815|NCT02252718|Other|Stool Assessment|"After passing a stool by the child participating in the study, within a short-time interval (<5 min), the stool will be assessed independently by one of the parents and the medical doctor. At the same time a parent will take 2 photos with phone photographic camera. Then the photographs will be independently evaluated by another doctor who will be unaware of both the in vivo stool appraisal and child condition."
16087816|NCT02252692|Drug|Enalapril|oral administration
16087874|NCT02252302|Drug|Salbutamol inhalation|Study participants will be exposed to 400ug of salbutamol prior to entering the air pollution chamber.
16087817|NCT02252666|Device|Neuromodulation Rehabilitation|CN-NINM uses sequenced patterns of electrical stimulation on the tongue. Our hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII.
16087818|NCT02252640|Biological|RTS,S/AS01B (50mcg of RTS,S and standard adult dose of AS01)|
16087819|NCT02252640|Biological|RTS,S/AS01B (10mcg of RTS,S and one fifth of the standard dose of AS01)|
16087820|NCT02252640|Biological|ChAd63 ME-TRAP (5 x 10^10 vp)|
16087821|NCT02252640|Biological|MVA ME-TRAP (2 x 10^8 pfu)|
16087822|NCT02252627|Drug|Administration of phenylephrine|Intravenous phenylephrine will be administered in 50-100 microgram increments until the mean arterial blood pressure has increased by 25% compared to baseline, or until a maximum dose of 1mg has been administered.
16087823|NCT02252627|Other|Measurement of stroke volume|The measurement of stroke volume will be performed using an Oesophageal Doppler Monitor
16087824|NCT02252627|Other|Contrast enhanced ultrasound scan|Microvascular blood flow will be measured using a contrast enhanced ultrasound scan
16087825|NCT02252627|Drug|Administration of ephedrine|Intravenous ephedrine will be administered in 3-6mg increments until the mean arterial blood pressure has increased by 25% compared to baseline, or until a maximum dose of 30mg has been administered.
16087826|NCT02252614|Drug|naproxen sodium codein|Pain intensity, contramal consumption
16087827|NCT02252614|Drug|paracetamol codein|Pain intensity, contramal consumption
16087828|NCT02252614|Drug|Placebo|Pain intensity, contramal consumption
16087829|NCT02252601|Other|HFDT test|
16087830|NCT02252601|Other|Pure tone Audiogram|
16087831|NCT02252588|Drug|Chlorhexidine|Oral Rinse
16087832|NCT02252588|Other|Placebo|Oral Rinse
16087833|NCT02252575|Device|Electromagnetic field|Exposure to the electromagnetic fields of electric motors
16087834|NCT02252562|Device|Sage Personal Hand Hygiene System|Utilization of a health care provider worn personal hand hygiene system during routine practice in the intra-operative setting with provider specific individual feedback.
16087835|NCT02252549|Device|SPIES+WLI assisted TURB|
16087836|NCT02252549|Device|WLI assisted TURB|
16087837|NCT02252536|Drug|gabapentin enacarbil|Horizant Extended Release Tablets, 600 mg, white to off-white, oval shaped tablets, taken 2 times per day
16087838|NCT02252536|Drug|Placebo|Placebo tablet, white to off-white, oval shaped tablets, taken 2 times per day
16087839|NCT02252523|Drug|Dexmedetomidine|
16087840|NCT02252510|Other|HALOSPERM|
16087841|NCT02252497|Drug|Active comparator : Tranexamic Acid (Exacyl)|"1g Exacyl Intra Venous, just before surgery
~Then infusion of 1g of Exacyl over eight hours ."
16087842|NCT02252497|Drug|Placebo comparator : physiologic serum|"1g Intra Venous just before surgery
~Then infusion of 1g of physiologic serum over eight hours"
16087843|NCT02252484|Other|Weight Loss Program|Program has four main components: diet, physical activity, coaching and diet and exercise monitoring. The program is tailored to each individual in the study.
16087844|NCT02252484|Other|Standard of Care|Standard of Care for this patient population.
16087845|NCT02252471|Behavioral|Choices-Teen|Choices-Teen participants in this condition will receive two brief motivational-interviewing-based counseling sessions, and one counseling session with a physician.
16087846|NCT02252458|Drug|Fentanyl|
16087847|NCT02252445|Drug|Propofol|Propofol will be administered.
16087848|NCT02252445|Drug|Sevoflurane|Sevoflurane will be administered.
16087849|NCT02252432|Drug|Ketamine|A bolus of intravenous (IV) ketamine during induction (0.5mg/kg), and an IV infusion of ketamine intraoperatively (5 mcg/kg/min)
16087850|NCT02252432|Drug|Methadone|A single dose of IV methadone (0.2 mg/kg) preinduction.
16087851|NCT02252432|Drug|Ketamine + methadone|Methadone (0.2 mg/kg) preinduction, a bolus of IV ketamine (0.5 mg/kg) during induction and IV ketamine infusion intraoperatively (5 mcg/kg/min)
16087852|NCT02252419|Drug|Dexamethasone|Dexamethasone will be administered.
16087853|NCT02252419|Drug|Paracetamol|Paracetamol will be administered.
16087854|NCT02252406|Drug|Ranolazine|Ranolazine 500 mg from baseline to week 3 and 1000 mg thereafter until week 24
16087855|NCT02252406|Other|Placebo|Matching placebo tablets daily for 24 weeks.
16087856|NCT02252393|Procedure|robot-assisted laparoscopic surgery|Undergo RARC with IUD
16087857|NCT02252393|Procedure|robot-assisted laparoscopic surgery|Undergo RARC with EUD
16087858|NCT02252393|Other|intraoperative complication management/prevention|Undergo RARC with IUD
16087859|NCT02252393|Other|intraoperative complication management/prevention|Undergo RARC with EUD
16087860|NCT02252393|Other|quality-of-life assessment|Ancillary studies
16087861|NCT02252380|Device|Transcranial ExAblate System|MR Guided Focused Ultrasound
16087862|NCT02252367|Drug|Tadalafil|Tadalafil 5 mg once daily for 12 weeks.
16087863|NCT02252367|Other|Placebo|Placebo tablet once daily for 12 weeks.
16087864|NCT02252354|Drug|[14C]-TAK-385 Oral Solution|TAK-385 oral radiolabelled solution
16087865|NCT02252354|Drug|TAK-385 Tablets|TAK-385 tablets 2 X 40 mg
16087866|NCT02252354|Drug|[14C]-TAK-385 Solution for Intravenous Infusion|TAK-385 intravenous (IV) radiolabelled solution
16087867|NCT02252341|Dietary Supplement|N-Acetyl-Cysteine|drug: N-Acetyl-cysteine N-Acetyl-cysteine 1800 mg a day for 12 weeks versus placebo for 12 weeks
16087868|NCT02252328|Drug|Simvastatin|Simvastatin 80mg once daily
16087869|NCT02252328|Drug|Placebo|Placebo tablets once daily
16087870|NCT02252315|Other|Educational Brochure|Participants will receive written education materials about mild traumatic brain injury.
16087871|NCT02252315|Other|Verbal education module|A structured in-person education module about mild traumatic brain injury.
16087872|NCT02252302|Other|Rest (Sitting on chair)|Study participants will sit on a chair for 60min. This is to simulate physical resting condition.
16087873|NCT02252302|Other|Cycling exercise|Study participants will exercise on a cycle ergometer for 45min. Participants will start their 30-min long constant workload exercise test test 60-min after the drug intervention. The exercise test will be set to a resistance of 50% of the maximal wattage that was reached on the graded exercise test on the screening day. The cycling exercise intervention will follow the rest-intervention.
16087910|NCT02252042|Biological|pembrolizumab|
16087875|NCT02252302|Drug|Placebo inhalation|Study participants will inhale a placebo (placebo for salbutamol) prior to entering the air pollution chamber
16087876|NCT02252302|Other|Diesel Exhaust Exposure|Participants will be exposed to PM2.5 of 300 μg/m3
16087877|NCT02252302|Other|Filtered air|Participants will be breathing filtered air
16087878|NCT02252276|Procedure|Experimental (proprioception exercises, muscle strengthening, joint mobilization)|The experimental group performed a combined protocol of proprioception (the patient doing exercises standing on an unstable plane)exercises and muscle strengthening (The patient performed eccentric exercises to work the movement inversion of ankle), and joint mobilization techniques of the ankle joint two session per week, during four weeks
16087879|NCT02252276|Procedure|Control (proprioception exercises, muscle strengthening)|The control group performed only proprioception exercises (the patient doing exercises standing on an unstable plane) and muscle strengthening (The patient performed eccentric exercises to work the movement inversion of ankle). Two sessión per week during four weeks
16087880|NCT02252263|Drug|Elotuzumab|
16087881|NCT02252263|Drug|Lirilumab|
16087882|NCT02252263|Drug|Urelumab|
16087883|NCT02252250|Procedure|conventional laparoscopic total mesentery excision|conventional laparoscopic total mesentery excision
16087884|NCT02252250|Procedure|transanal hybrid-laparoscopic total mesentery excision|transanal laparoscopic total mesentery excision for rectal cancer. Mobilize the rectum from down- to-up. Then, set a single incision laparoscopic surgery (SILS) port at the right-low abdomen to resect the lymph nodes of IMA.
16087885|NCT02252237|Biological|Pharmacokinetic|Blood sample of 2 ml at enrolment and then at following visits. Buccal cell collection swab
16087886|NCT02252211|Drug|DS-8895a 1 mg/kg|Patients received infusions with ^89Zr-Df-DS-8895a at a dose of 0.2 mg/kg on Day 1, DS-8895a at a dose of 1 mg/kg on Days 8 and 22, and ^89Zr-Df-DS-8895a at a dose of 1 mg/kg on Day 36. Patients who responded or had stable disease per RECIST version 1.1 at the Day 50 restaging may have continued to receive biweekly treatment with DS-8895a until disease progression.
16087887|NCT02252211|Drug|DS-8895a 3 mg/kg|Patients received infusions with ^89Zr-Df-DS-8895a at a dose of 0.2 mg/kg on Day 1, DS-8895a at a dose of 3 mg/kg on Days 8 and 22, and ^89Zr-Df-DS-8895a at a dose of 3 mg/kg on Day 36. Patients who responded or had stable disease per RECIST version 1.1 at the Day 50 restaging may have continued to receive biweekly treatment with DS-8895a until disease progression.
16087888|NCT02252211|Drug|DS-8895a 10 mg/kg|Patients were to receive infusions with ^89Zr-Df-DS-8895a at a dose of 0.2 mg/kg on Day 1, DS-8895a at a dose of 10 mg/kg on Days 8 and 22, and ^89Zr-Df-DS-8895a at a dose of 10 mg/kg on Day 36. Patients who responded or had stable disease per RECIST version 1.1 at the Day 50 restaging may have continued to receive biweekly treatment with DS-8895a until disease progression.
16087889|NCT02252198|Other|Epistem Genedrive® and MolBio Truenat™|S1 will undergo direct smear and Epistem Genedrive® (optional for phase 2*) testing, before being homogenized with glass beads and split into three portions for testing with Epistem Genedrive®, MolBio Truenat™ and GeneXpert MTB/Rif® respectively. S2 and S3 will be randomized as to the order of testing using Epistem Genedrive® and MolBio Truenat™.
16087890|NCT02252185|Device|Johnson&Johnson Medical Suzhou made Spine Fusion System|interventional device is Spine Fusion System that is manufactured by Johnson & Johnson Medical Suzhou Ltd.
16087891|NCT02252185|Device|Imported EXPEDIUM screws and OPAL cage|Comparator in this study is active comparator.
16087892|NCT02252172|Drug|Daratumumab IV|Daratumumab will be administered at a dose of 16 milligram per kilogram (mg/kg) by intravenous (IV) infusion, once a week for 8 weeks, then once every other week for 16 weeks, thereafter once every 4 weeks until documented progression of disease, unacceptable toxicity, or end of study (maximum up to 7 years).
16087893|NCT02252172|Drug|Lenalidomide|Lenalidomide 25 mg capsule orally on Day 1 through Day 21 of each 28-day cycle.
16087894|NCT02252172|Drug|Dexamethasone|Dexamethasone 40 mg orally or intravenously once in a week.
16087895|NCT02252172|Drug|Daratumumab SC|Daratumumab SC will be administered by SC injection at a fixed dose of 1800 mg once every 4 weeks until documented progression, unacceptable toxicity, or study end. Following implementation of protocol amendment 8, participants still receiving treatment with daratumumab IV will have the option to switch to daratumumab SC on Day 1 of any cycle, at the discretion of the investigator.
16087896|NCT02252146|Drug|IMO-8400|MO-8400 given subcutaneously twice weekly
16087897|NCT02252133|Device|Delefilcon A contact lenses|Silicone hydrogel contact lenses (8.5 and 8.8 base curves) dispensed per manufacturer's guidelines for daily disposable wear
16087898|NCT02252133|Device|Narafilcon A contact lenses|Silicone hydrogel contact lenses (8.5 and 9.0 base curves) dispensed per manufacturer's guidelines for daily disposable wear
16087899|NCT02252120|Device|Supreme|
16087900|NCT02252120|Device|Laryngeal Tube|
16087901|NCT02252107|Drug|decitabine|Single arm study: the addition of 10 days (20 mg/m2) decitabine to the conditioning regimen prior to allogeneic hematopoietic transplantation.
16087902|NCT02252094|Device|Prismalung|Prism lung (Baxter Healthcare/Gambro Lund, Sweden) is an extracorporeal carbon dioxide removal device. It removes blood through a double lumen catheter and pumps it through a hollow fiber gas exchange cartridge which is impervious to fluid. Carbon dioxide diffuses out, down a concentration gradient which is maintained by sweep gas flowing through the centre of the hollow fibres. The decarboxylated blood is returned to the patient through the double lumen catheter.
16087903|NCT02252094|Other|Ultra-protective ventilation|Ventilation with </= 3ml/kg predicted body weight
16087904|NCT02252094|Other|Conventional Lung Protective Ventilation|Ventilation with 6ml/kg predicted body weight
16087905|NCT02252081|Drug|metformin|500 to 1500 mg orally per day for 16 weeks if eGFR > 45 ml/min; 500 to 1000 mg orally per day for 16 weeks if eGFR =< 45 ml/min
16087906|NCT02252081|Drug|Placebo|placebo pill(s) orally per day for 16 weeks
16087907|NCT02252068|Behavioral|I-CBT|New cognitive behavioral therapy treatment manual developed to treat co-occurring anxiety and opioid dependency disorders.
16087908|NCT02252068|Behavioral|IDC|Individual Drug Counseling manual that has demonstrated efficacy for the treatment of drug dependence.
16087909|NCT02252055|Biological|ATDC_Nantes|"ATDC treatment (1 x 106 cells/kg BW slow peripheral venous) occurs the day before transplantation into recipients also recipients of a living donor renal transplantation.
~Recipients also receive prednisolone, Mycophenolate Mofetil and tacrolimus background immunosuppression ( as described in detail in the arm description)"
16087911|NCT02252042|Drug|methotrexate|
16087914|NCT02252016|Drug|Grazoprevir + Elbasvir|FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken once daily by mouth.
16087915|NCT02252016|Drug|Placebo|Placebo tablets matching grazoprevir + elbasvir FDC tablets taken once daily by mouth.
16087916|NCT02252003|Other|Pain scales testing|
16087917|NCT02251990|Drug|Grazoprevir/Elbasvir|FDC tablet containing 100 mg of grazoprevir and 50 mg of elbasvir taken q.d. by mouth for 12 weeks.
16087918|NCT02251990|Drug|Placebo|Placebo tablet matching grazoprevir/elbasvir FDC tablet taken q.d. by mouth for 12 weeks.
16087919|NCT02251977|Drug|GM1|GM1 will be delivered to patients through the day before the initiation of chemotherapy (Day0) to the completion of chemotherapy (Day4), and the dosages of GM1 for patients who receive mFOLFOX6 or XELOX are 80mg or 120mg per day.
16087920|NCT02251977|Drug|placebo|Placebo will be delivered to patients through the day before the initiation of chemotherapy (Day0) to the completion of chemotherapy (Day4), and the dosages of placebo for patients who receive mFOLFOX6 or XELOX are 80mg or 120mg per day.
16087921|NCT02251977|Drug|mFOLFOX6 or XELOX|"mFOLFOX6: Patients will receive mFOLFOX6 every 14 days, Oxaliplatin 85mg/m2 IV over 3 hours on Day1; Calcium Folinate IV over 2h on Day 1(Leucovorin 200mg/m2 or CF 400 mg/m2); 5-Fluorouracil 400mg/m2 IV on Day1; followed by 5-Fluorouracil 2.4g/m2 for 46 hours continuous infusion on Day1.
~XELOX: Patients will receive XELOX every 21 days, Oxaliplatin 130mg/m2 IV over 3 hours on Day1;followed by Capecitabine 1000mg/m2 oral twice daily for 14 days.
~The optimum chemotherapy regimen is at the discretion of the investigators based on the condition of each patient."
16087922|NCT02251964|Drug|Rituximab|2 times 1000mg dose at 14 days interval treatment
16087923|NCT02251964|Radiation|Zr-89-rituximab immuno PET/CT|Immuno labeled PET/CT of the lungs
16087924|NCT02251951|Drug|nab-Paclitaxel|Abraxane: 150mg/m2 i.v weekly for 3 consecutive weeks followed by a week of rest (28d)
16087925|NCT02251938|Drug|DE-109 440 μg|Medium Dose
16087926|NCT02251925|Biological|frozen Embryo transfer|In this study all patients who will undergo frozen embryo transfer are randomly allocated to be prepared for transfer by using either natural cycle (with or without hCG for ovulation induction) or Hormonal cycle (with or without administration of GnRH-a).
16087927|NCT02251925|Drug|10,000U hCG injection|In natural cycle with hCG, after detection of mature follicles in ultrasound and endometrial thickness over 7mm, 10,000IU hCG is injected for ovulation and embryo transfer is performed 3-5 days later in cleavage stage.
16087928|NCT02251925|Drug|GnRH agonist (Superfact)|In group 3, injection of GnRH agonist (Superfact) at a subcutaneous daily dose of 0.5 mg is started on the day 17-19 of the natural menstrual cycle. Once pituitary desensitization is confirmed, hormonal treatment is commenced with 4mg/day oral Estradiol valerate and after 7 days if endometrial thickness is adequate, Estradiol administration will be continued with the same dose and 100mg Progesterone is administered before embryo transfer, otherwise patients are candidates for higher dosage of Estradiol till favourable endometrial thickness is achieved.
16087929|NCT02251925|Drug|administration of 6 mg Estradiol valerate|In the hormonal group without GnRH-a, endometrial preparation will be started with daily administration of 6 mg Estradiol valerate from the 2nd day of the natural menstrual cycle for 6 days. Then treatment will be continued similar to the 3rd group.
16087930|NCT02251912|Drug|Intranasal Oxytocin|10 insufflations (40IU of oxytocin total) given 3 initially then 2 times daily for 12 weeks
16087931|NCT02251912|Drug|Placebo|10 insufflations (same solution as active treatment minus oxytocin) given 3 initially and then 2 times daily for 12 weeks
16087932|NCT02251899|Behavioral|Disease-Management intervention|The participants in the intervention group receive a nurse-managed disease-management intervention that is regularly delivered by telephone or, when necessary, in person
16087933|NCT02251886|Other|Moxibustion in primiparae|Number of primiparae participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment
16087934|NCT02251886|Other|Moxibustion in multiparae|"Number of multiparae participants with Version of Fetal Breech Position to Cephalic Position up to 4 weeks after treatment"
16087935|NCT02251873|Drug|TPV + RTV (low dose)|
16087936|NCT02251873|Drug|TPV + RTV (high dose)|
16087937|NCT02251873|Drug|ddl|
16087938|NCT02251847|Drug|Rosuvastatin/Ezetimibe|Rosuvastatin 5mg
16087939|NCT02251834|Behavioral|Community Health Worker (CHW)|The primary mechanism used by the Community Health Worker (CHW) for delivering interventions will be a) home visits b) phone based contacts c) group level activities d) mobile technology. Ideally, each subject will have, at a minimum, 4 home visits and ten phone calls during months 3-12. Group visits will held twice a month. The Community Health Worker (CHW) intervention will be highly individualized and tailored to unique circumstances of each patient and we expect home visits, calls, ProMobile usage and group visits to vary by patient.
16087940|NCT02251834|Other|usual care and health education brochures every 4 months.|Patients randomized to the control group will receive usual care.
16087941|NCT02251821|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic hematopoietic stem cell transplant
16087942|NCT02251821|Drug|Busulfan|Given IV
16087943|NCT02251821|Drug|Cyclophosphamide|Given IV
16087944|NCT02251821|Drug|Fludarabine Phosphate|Given IV
16087945|NCT02251821|Other|Laboratory Biomarker Analysis|Correlative studies
16087946|NCT02251821|Drug|Melphalan|Given IV
16087947|NCT02251821|Drug|Methotrexate|Given IV
16087948|NCT02251821|Drug|Mycophenolate Mofetil|Given IV or PO
16087949|NCT02251821|Drug|Ruxolitinib|Given PO
16087950|NCT02251821|Drug|Tacrolimus|Given IV or PO
16087951|NCT02251821|Radiation|Total-Body Irradiation|Undergo TBI
16087952|NCT02251821|Procedure|Umbilical Cord Blood Transplantation|Undergo umbilical cord blood transplant
16087953|NCT02251795|Drug|Tipranavir|
16087954|NCT02251795|Drug|Ritonavir|
16087955|NCT02251795|Drug|Darunavir|
16087956|NCT02251795|Drug|Aspirin|single dose on day 2
16088005|NCT02251496|Other|Oral nutrition supplement (ONS-group)|The subjects in this group will be provided with and encouraged to take two ready to drink oral nutrition supplements (ONS) daily, providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).
16088006|NCT02251483|Other|Serum-derived bovine immunoglobulin protein isolate (SBI)|
16088007|NCT02251483|Other|Placebo|
16087957|NCT02251782|Device|Epi proColon Test|Subjects assigned to the Epi proColon arm will receive information on the Epi proColon test outlined in a template script. They will then be offered a blood draw for Epi proColon testing. The blood draw can be fulfilled at the clinic or at a specified blood draw station, at the convenience of the patient. Epi proColon plasma samples will be sent to a central laboratory for testing. If no test result is recorded within 4 weeks, patients will be mailed a reminder to complete testing. If no result is recorded within 2 weeks of the mailed reminder, subjects will be recorded as non-adherent to screening. Subjects with negative test results will be mailed a notice of result and reminder to continue screening. Subjects with positive tests will be contacted and counseled to undergo colonoscopy.
16087958|NCT02251782|Device|Fecal Immunochemical Test (FIT)|Subjects assigned to the FIT arm will receive information on the FIT test outlined in a template script. They will then be provided a FIT kit to take home and asked to send a stool sample to the testing lab following the kit instructions. If no test result is recorded within 4 weeks, subjects will receive a mailed reminder to complete testing. If no result is recorded within 2 weeks of the mailed reminder, subjects will be recorded as non-adherent to screening. Subjects with negative test results will be mailed a notice of result and reminder to continue screening. Subjects with positive tests will be contacted and counseled to undergo colonoscopy.
16087959|NCT02251769|Drug|Tipranavir|
16087960|NCT02251769|Drug|Ritonavir|
16087961|NCT02251769|Drug|Clarithromycin|
16087962|NCT02251769|Other|High-Fat Test Meal|
16087963|NCT02251756|Device|Actinica, 0.8 mg/cm2, 1 application|
16087964|NCT02251756|Device|Actinica, 0.8 mg/cm2, 2 applications|
16087965|NCT02251756|Device|Actinica, 2 mg/cm2, 1 application|
16087966|NCT02251756|Device|Actinica, 2 mg/cm2, 2 applications|
16087967|NCT02251743|Device|Neurofeedback treatment|"Each session, the child participates in 5 training tasks. Each task lasts 5 minutes at the beginning and gradually increases to 9 minutes per task over the course of the neurofeedback as the child's attention span improves. We record four results for each of the 5 tasks:
~The number of half-second periods that they met the reward parameters (i.e. theta mV below threshold; beta mV above threshold)
~Average voltage of theta waves
~Average voltage of beta
~Average ratio of theta to beta power (TBR)"
16087968|NCT02251730|Behavioral|Smoking cessation|Refer for smoking cessation
16087969|NCT02251717|Drug|LDV/SOF|90/400 mg FDC tablet administered orally once daily
16087970|NCT02251704|Procedure|Blood sampling|Capillary blood samples collected by finger/heel prick for determination of parasite prevalence at the time of survey.
16087971|NCT02251704|Diagnostic Test|Assessment of body temperature|Axillary body temperature of all subjects recorded by a digital thermometer at the time of survey.
16087972|NCT02251691|Drug|Advagraf|Compare the drug compliance between once daily or twice daily regimen
16087973|NCT02251691|Drug|Prograf|Compare the drug compliance between once daily or twice daily regimen
16087974|NCT02251678|Dietary Supplement|Elimune Capsules|2 capsules BID for 28 days
16087975|NCT02251665|Other|No intervention|a single-center prospective observational study
16087976|NCT02251652|Drug|Ingenol Mebutate|Ingenol mebutate 0.05% gel
16087977|NCT02251652|Procedure|Cryotherapy|1-2 sprays, 5 seconds each, with a 5 second interval
16087978|NCT02251639|Behavioral|Questionnaire|Participant completes a short questionnaire regarding their awareness of oral cancer and risk factors.
16087979|NCT02251639|Device|POS + PS2 + VELscope|Oral cavity examined with one or more of the widefield imaging devices, such as the VELscope and/or PS2 device.
16087980|NCT02251639|Procedure|Oral Brush Biopsy|If abnormal areas found, a small brush is pressed against an area inside mouth, and turned 5-10 times. The areas that could be biopsied include gums, tongue, roof of mouth, bottom of mouth, or the inside of cheeks.
16087981|NCT02251626|Dietary Supplement|coenzyme Q10|It is a randomized and double blind study so patients or his/her doctor will not know which group s/he is in.
16087982|NCT02251626|Dietary Supplement|Placebo|It is a randomized and double blind study so patients or his/her doctor will not know which group s/he is in.
16087983|NCT02251613|Drug|Olopatadine HCl ophthalmic solution, 0.1%|
16087984|NCT02251613|Drug|Epinastine HCl ophthalmic solution, 0.05%|
16087985|NCT02251600|Drug|Deflazacort|Oral deflazacort administered once daily at 0.9 mg/kg for eight days
16087986|NCT02251587|Other|Standard Weight Management Program|Standard Diet program based on diet and exercise.
16087987|NCT02251587|Other|Sensible Weigh Program|Weight loss program designed for low income women.
16087988|NCT02251574|Other|Low Calorie Diet|Weight management program designed around a low calorie diet.
16087989|NCT02251574|Other|Very Low Calorie Diet|Weight management program designed around a very low calorie diet.
16087990|NCT02251574|Other|Standard Care|Care provided that would normally be given to people meeting eligibility criteria for this study.
16087991|NCT02251561|Device|FID 109182|Investigational multipurpose contact lens cleaning and disinfecting solution
16087992|NCT02251561|Device|Opti-Free Plus|Commercially available multipurpose contact lens cleaning and disinfecting solution
16087993|NCT02251561|Device|Senofilcon A contact lens|Commercially available silicone hydrogel contact lens
16087994|NCT02251548|Drug|Ibrutinib|Oral BTK inhibitor
16087995|NCT02251548|Drug|Fludarabine|IV purine analogue chemotherapy agent
16087996|NCT02251548|Drug|Cyclophosphamide|IV alkylator chemotherapy agent
16087997|NCT02251548|Drug|Rituximab|IV anti-CD20 monoclonal antibody
16087998|NCT02251535|Device|ATTUNE® Knee System|
16087999|NCT02251535|Device|PFC® SIGMA® Knee System|
16088000|NCT02251522|Device|ConforMIS Total Knee Replacement System|Total knee replacement system using a patient specific implant.
16088001|NCT02251522|Device|Off-the-Shelf Knee Replacement System|Total knee replacement system not using a patient specific implant.
16088002|NCT02251509|Drug|Carvedilol|
16088003|NCT02251509|Drug|Metoprolol tartrate|
16088004|NCT02251496|Other|In between meals snacks (Snacks-group)|In between meals snacks (Snacks-group): The subjects in this group will be provided with and encouraged to select in-between-meals snacks providing ~ 600 kcal/d in addition to the hospital food (during hospitalisation) or in addition to their daily diet at home (after discharge from the hospital).
16088069|NCT02251132|Drug|TPV low 2|
16088070|NCT02251132|Drug|TPV medium|
16088008|NCT02251470|Other|HBE Wii (EG)|Wii-Fit Balance games (Soccer Heading, Ski Slalom, Table Tilt, Balance Bubble etc.)
16088009|NCT02251470|Other|HBE Control (CG)|Simple balance exercises with own body weight (Single limb stance, stepping, side sways etc.)
16088010|NCT02251457|Drug|Ranolazine|Ranexa is FDA approved for chronic angina
16088011|NCT02251444|Procedure|outpatient rehabilitation program|
16088012|NCT02251444|Procedure|physical therapy|
16088013|NCT02251431|Drug|BYDUREON|Exenatide-extended release, Cohorts A and B
16088014|NCT02251431|Drug|Placebo|Cohort A only
16088015|NCT02251418|Device|Extracorporeal shockwave therapy|
16088016|NCT02251405|Behavioral|One bag, stainless container|
16088017|NCT02251392|Other|Chamomila recutita Gel|Gel formulated with active principles from Chamomilla recutita which dose is being determined in a dose-response curve
16088018|NCT02251392|Other|Chamomila recutita Infuse|chamomila infuse in a concentration of 2,5% already determined in a dose response curve
16088019|NCT02251392|Drug|Urea cream based|Urea is already using to treat radiodermatitis when it starts to occur, so it will be the usual care
16088020|NCT02251379|Drug|Flovent Diskus|Inhaled corticosteroids
16088021|NCT02251379|Other|Home Environmental Intervention|Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding
16088022|NCT02251379|Drug|Advair Diskus|inhaled corticosteroids + long-acting beta agonist
16088023|NCT02251366|Procedure|Physician-guided diagnostic|NVAMD participants in the physician-guided diagnostic arm will have receive injections based on diagnostic imaging provided by optical coherence tomography and optional fluorescein angiography, those in this group will only receive retinal examinations at the 4- and 8-month clinic visits.
16088024|NCT02251353|Procedure|intervention|hepatic and/or pulmonary resection, radiofrequency ablation (RFA), transcatheter arterial chemoembolization, CyberKnife stereotactic radiosurgery
16088025|NCT02251353|Drug|systemic treatment|Systemic therapy
16088026|NCT02251340|Behavioral|Eczema Care Plan|
16088027|NCT02251327|Device|Investigational Xpert DST test|One investigational test performed directly on the same sputum specimen.
16088028|NCT02251301|Dietary Supplement|Skim Milk|250 ml skim milk will be consumed by participants immediately and 1 hour after each of the 36 sessions of high-intensity interval training over a 12 week period.
16088029|NCT02251301|Behavioral|High intensity interval training|All participants will undergo a 12 week high intensity interval training program consisting of 3 supervised sessions a week of 4-10 x 1 min high intensity interval alternating with 1 min of recovery.
16088030|NCT02251301|Other|Placebo|250 mL water will be consumed by participants immediately and 1 hour after each of the 36 sessions of high-intensity interval training over a 12 week period.
16088031|NCT02251301|Dietary Supplement|Macronutrient isoenergetic control|250 mL of protein+cho matched drink will be consumed by participants immediately and 1 hour after each of the 36 sessions of high-intensity interval training over a 12 week period.
16088032|NCT02251288|Biological|Influenza Virus Vaccine, Live Attenuated H7N9 Anhui 2013/AA ca|MedImmune supplies pLAIV vaccines as a colorless to pale yellow and clear to slightly cloudy suspension in single, unit-dose, Becton-Dickinson Accuspray™ Nasal Spray Systems sprayer devices. Each filled sprayer device contains a 0.5 mL dose of 10^7FFU of H7N9 Anhui 2013/AA ca vaccine. Group I receives the IN dose on Day 29, Group 2 on Day 85, and Group 3 on Day 169.
16088033|NCT02251288|Biological|Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013|Sanofi supplies the monovalent influenza A/H7N9 virus vaccine as a sterile, clear, and slightly opalescent suspension in single-dose vials containing 15 mcg HA per 0.5 mL. Group 1 through Group5 will receive the IM vaccine on Day 1
16088034|NCT02251288|Drug|MF59 adjuvant|Novartis supplies the MF59 adjuvant as an oil-in-water milky emulsion in single-use vials containing a fill volume of 0.7 mL. Group 1 through Group 5 will receive MF59 IM on Day 1.
16088035|NCT02251275|Drug|Tolvaptan|Tolvaptan tablets (15 or 30 mg) self-administered orally as split-dose regimens, once upon awakening and another approximately 8 to 9 hours later
16088036|NCT02251262|Device|Whole-body 18FDG-PET-CT scan|18FDG-PET-CT exam will be performed in patients, with suspicion of pacing or defibrillation lead infection, hospitalized in cardiology unit.
16088037|NCT02251249|Drug|Paracetamol concentration time curve from 0 to 120 min|It consists in oral ingestion of 1.5g of paracetamol (Contents of 3 Doliprane® capsules 500 mg) and 60 mg prasugrel (6 tablets Efient ® 10 mg) or 180 mg ticagrelor ( 2 tablets Brilique ® 90 mg) with water. Then Paracetamol concentration is followed by the realization of the curve of concentration of paracetamol in plasma samples. These samples are taken at 15 min intervals during the first 2 hours.
16088038|NCT02251236|Drug|Stribild|To be administered orally, once daily with food.
16088039|NCT02251236|Drug|Genvoya|To be administered orally, once daily with food.
16088040|NCT02251223|Drug|Tipranavir low dose|
16088041|NCT02251223|Drug|Tipranavir medium dose|
16088042|NCT02251223|Drug|Tipranavir high dose|
16088043|NCT02251223|Drug|Ritonavir low dose|
16088044|NCT02251223|Drug|Ritonavir high dose|
16088045|NCT02251210|Drug|BIIL 284 BS low dose|
16088046|NCT02251210|Drug|BIIL 284 BS medium dose|
16088047|NCT02251210|Drug|BIIL 284 BS high dose|
16088048|NCT02251210|Drug|Placebo|
16088049|NCT02251197|Drug|BIII 890 CL|
16088050|NCT02251197|Drug|Placebo|
16088051|NCT02251184|Drug|Aggrenox|
16088052|NCT02251184|Drug|Dipyridamole|
16088053|NCT02251184|Drug|Aspirin|
16088054|NCT02251184|Drug|Lansoprazole|
16088055|NCT02251171|Drug|Tipranavir|
16088056|NCT02251171|Drug|Ritonavir|
16088057|NCT02251171|Drug|Rifabutin|
16088058|NCT02251158|Drug|Tipranavir oral solution|
16088059|NCT02251158|Drug|Tipranavir capsules|
16088060|NCT02251158|Drug|Ritonavir oral solution|
16088061|NCT02251158|Drug|Ritonavir soft gel capsules|
16088062|NCT02251158|Other|High fat breakfast|
16088063|NCT02251145|Drug|Tipranavir low dose|
16088064|NCT02251145|Drug|Tipranavir high dose|
16088065|NCT02251145|Drug|Ritonavir low dose|
16088066|NCT02251145|Drug|Ritonavir high dose|
16088067|NCT02251145|Drug|Tenofovir disoproxil fumarate|
16088068|NCT02251132|Drug|TPV low 1|
16088079|NCT02251106|Device|Lumbar corset (Quickdraw, Aspen Medical Products)|The corset (a.k.a. brace) is made of webbing and elastic. It is wrapped around the trunk and tightened with Velcro and a series of cords (like tying shoes).
16088080|NCT02251093|Drug|Lcr Regenerans|Dosage: 1 vaginal capsule per day Route of administration: intravaginal Treatment duration: One 21-day cycle
16088081|NCT02251093|Drug|Placebo|Dosage: 1 vaginal capsule per day Route of administration: intravaginal Treatment duration: One 21-day cycle
16088082|NCT02251067|Drug|VPI-2690B low dose|Comparison of different doses of study drug
16088083|NCT02251067|Drug|VPI-2690B medium dose|Comparison of different doses of study drug
16088084|NCT02251067|Drug|Placebo to match VPI-2690B|
16088085|NCT02251067|Drug|VPI-2690B high dose|Comparison of different doses of study drug
16088086|NCT02251054|Other|Avatar group|We developed and tested the online program of three multimedia tutorials using the game development and rendering engine (Unity3D, Unity Technologies, San Francisco, CA). This arm saw the tutorials with Avatars.
16088087|NCT02251054|Other|No Avatar group|We developed and tested the online program of three multimedia tutorials using the game development and rendering engine (Unity3D, Unity Technologies, San Francisco, CA). This arm saw the tutorials without Avatars.
16088088|NCT02251041|Drug|Antithrombin-III|
16088089|NCT02251041|Drug|Infliximab|
16088090|NCT02251041|Drug|Apotransferrin|
16088091|NCT02251041|Drug|Human recombinant erythropoietin|
16088092|NCT02251041|Drug|C1-Inhibitor|
16088093|NCT02251041|Drug|Glutathione|
16088094|NCT02251041|Drug|Alfa-tocopherol|
16088095|NCT02251041|Drug|Melatonin|
16088096|NCT02251041|Drug|Epoprostenol|
16088097|NCT02251041|Drug|Sodium chloride solution|
16088098|NCT02251028|Behavioral|Value-based cognitive-behavioral therapy|The intervention is a manualized program specifically tailored for prevention of disability and psychological distress after whiplash injuries. The intervention is delivered by two trained clinical psychologists og consists of 10 weekly one-hour individual sessions.
16088099|NCT02251015|Procedure|occlusal plate|"In the plate group arm, the patients used the occlusal splints for all night plus 4 hours during the day and they made therapeutic exercises 15 repetitions 3 times a day.
~The orientation for therapeutic exercises seek to correctly position the jaw in the resting position (maxillary teeth approximately 2mm away from the mandibular teeth and the tip of the tongue accommodated on top of the incisive papilla on the hard palate, beyond an exercise that consisted of repeated opening and closing movements paying close attention to the position of the tongue, the point of which being accommodated on the incisive papilla during the exercises. The patient was instructed to perform 15 repetitions 3 times a day."
16088100|NCT02251015|Procedure|therapeutic exercises|The orientation for therapeutic exercises seek to correctly position the jaw in the resting position (maxillary teeth approximately 2mm away from the mandibular teeth and the tip of the tongue accommodated on top of the incisive papilla on the hard palate, beyond an exercise that consisted of repeated opening and closing movements paying close attention to the position of the tongue, the point of which being accommodated on the incisive papilla during the exercises. The patient was instructed to perform 15 repetitions 3 times a day.
16088101|NCT02250976|Drug|Livasupril Cap.160/2mg|Fenofibrate pellet( as micronized fenofibrate 160mg) and Pitavastatin Ca 2mg
16088102|NCT02250976|Drug|Lipilfen cap. 160mg|Micronized fenofibrate 160mg
16088103|NCT02250976|Drug|Livaro tab. 2mg|Pitavastatin Ca 2mg
16088104|NCT02250950|Behavioral|MI and SDT Exercise Group|The intervention group will participate in a group exercise class that will be held once a week for an hour. This class will be taught by an instructor trained in MI and SDT. This individual will lead group discussions and will have the participants exercise together.
16088105|NCT02250950|Behavioral|Non-MI and SDT Exercise Group|This group will participate in a group exercise class that will be held once a week for an hour. This class will be taught by an instructor who was not trained in MI and SDT. This individual will lead a regular exercise class.
16088106|NCT02250937|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic PBSCT
16088107|NCT02250937|Drug|Busulfan|Given IV
16088108|NCT02250937|Drug|Cladribine|Given IV
16088109|NCT02250937|Drug|Fludarabine Phosphate|Given IV
16088110|NCT02250937|Other|Laboratory Biomarker Analysis|Correlative studies
16088111|NCT02250937|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo allogeneic PBSCT
16088112|NCT02250937|Other|Pharmacological Study|Correlative studies
16088113|NCT02250937|Drug|Venetoclax|Given PO
16088114|NCT02250924|Dietary Supplement|Caffeine|caffeinated gum
16088115|NCT02250924|Other|Gum|Chewing gum
16088116|NCT02250924|Behavioral|wear silicone bracelet|Subjects will put on bracelet to correspond with times for chewing gum
16088117|NCT02250911|Other|webcasts|
16088118|NCT02250911|Behavioral|Assessments|
16088119|NCT02250911|Other|Usual care|
16088120|NCT02250898|Other|Myofascial Massage Therapy|Myofascial Massage Therapy is a manual massage therapy consisting of the following techniques: fascial stretch, circular friction, deep fascial restriction release, arm pull, side latissimus dorsi stretch, twisting, moist heat application, cold therapy, and lymphatic drainage.
16088121|NCT02250898|Other|Global Relaxation Massage|Global Relaxation Massage is a manual massage therapy consisting of a full body relaxation massage that includes light kneading and stroking in order to restore a sense of well- being
16088122|NCT02250885|Drug|Selinexor|Selective Inhibitor fo Nuclear Export (SINE)
16088123|NCT02250872|Drug|Gemigliptin|Gemigliptin 100mg in 2 divided doses plus cisplatin
16088124|NCT02250872|Drug|Placebo|100mg in 2 divided doses plus cisplatin
16088125|NCT02250872|Drug|Cisplatin|All patients will receive intravenous cisplatin
16088126|NCT02250859|Drug|FMX101, Minocycline 4% foam|FMX101, Minocycline 4% foam to be applied twice daily for 16 consecutive days
16088127|NCT02250846|Drug|EGFR-TKI|egfr-TKI treatment
16088128|NCT02250833|Drug|CKD-828|Telmisartan 80mg /S-Amlodipine 5mg(FDC) Tablet, Oral, Once Daily
16088129|NCT02250833|Drug|Telmisartan|- Telmisartan 80mg tablet, Oral, Once Daily (Combination Therapy with S-amlodipine)
16088130|NCT02250833|Drug|S-amlodipine|- S-amlodipine 5mg tablet, Oral, Once Daily (combination Therapy with Telmisartan)
16088131|NCT02250820|Drug|Dexmedetomidine|Nasal administration
16088132|NCT02250820|Drug|Pentobarbital|Oral administration
16088133|NCT02250820|Other|Oral Placebo|Oral placebo will be cherry syrup
16088134|NCT02250820|Other|Nasal Placebo|Nasal placebo will be nasally atomized saline
16088135|NCT02250807|Drug|Simeprevir|Subjects will receive oral capsule of Simeprevir 150 mg, once a day from Day 1 up to Week 12.
16088136|NCT02250807|Drug|Sofosbuvir|Subjects will receive oral tablet of sofosbuvir 400 mg, once a day from Day 1 up to Week 12.
16088137|NCT02250794|Drug|metformin and sitagliptin|metformin 750 mg PO twice daily
16088138|NCT02250794|Drug|insulin glargine and insulin lispro|insulin glargine given once daily
16088139|NCT02250794|Drug|metformin and sitagliptin|sitagliptin 100 mg PO once daily
16088140|NCT02250794|Drug|insulin glargine and insulin lispro|insulin lispro given three times daily with meals
16088141|NCT02250781|Drug|Oral ONC201|Given PO
16088142|NCT02250768|Biological|GM-CSF|2ng/ml of GM-CSF supplemented into culture media
16088143|NCT02250755|Other|MRI T1 T2 sequences|MRI
16088144|NCT02250742|Other|dry needling|Dry needling uses traditional acupuncture needles without injecting any liquid. Dry needling is based on traditional Western medicine whereby the needle insertion sites are located in known anatomical landmarks such as skeletal muscles, fascia and occasionally joints, tendons and bone/tendon junctions.
16088145|NCT02250729|Other|intradermal pholcodine allergy test in cases|
16088146|NCT02250729|Other|Blood sampling|
16088147|NCT02250716|Procedure|cryotherapy|cryotherapy for cervical intraepithelial neoplasia in HIV infected women vs control arm of standard of care (repeat pap smear in 1 year)
16088148|NCT02250703|Drug|Midazolam|oral midazolam 0.5mg/kg upto maximum dose of 15mg
16088149|NCT02250703|Drug|Dexmedetomidine|intranasal dexmedetomidine 2mcg/kg upto maximum dose of 100mcg
16088150|NCT02250690|Device|experimental group - tDCS|
16088151|NCT02250690|Device|Control group (tDCS sham)|
16088152|NCT02250664|Other|Very low nicotine content cigarettes|Very low nicotine content cigarettes
16088153|NCT02250651|Drug|Bimatoprost SR|Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.
16088154|NCT02250651|Other|Sham: Applicator Without Needle|Sham administered on Day 1, Week 16, and Week 32.
16088155|NCT02250651|Drug|Active Comparator: Timolol 0.5%|Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
16088156|NCT02250651|Drug|Timolol Vehicle (placebo)|Timolol vehicle administered once in the morning and once in the evening for up to 20 months.
16088157|NCT02250638|Other|CA 19-9 Assay|Physicians use the CA 19-9 test results to manage their patients
16088158|NCT02250612|Drug|1 drop of 0.375% SYL040012 (bamosiran)|
16088159|NCT02250612|Drug|1 drop of 0.750% SYL040012 (bamosiran)|
16088160|NCT02250612|Drug|1 drop of 1.125% SYL040012 (bamosiran)|
16088161|NCT02250612|Drug|1 drop of 1.5% SYL040012 (bamosiran)|
16088162|NCT02250612|Drug|1 drop of 0.5 % timolol maleate|
16088163|NCT02250599|Drug|Paclitaxel|Paclitaxel 175 mg/m2 IV Day 1 each 3-week cycle
16088164|NCT02250599|Drug|Bevacizumab|Bevacizumab 7.5 mg/kg Day 1 each 3-week cycle
16088165|NCT02250599|Drug|Carboplatin|Carboplatin AUC 6 IV Day 1 each 3-week cycle
16088166|NCT02250586|Behavioral|CBT-CSO|Internet-delivered cognitive-behavioral therapy for CSO's of treatment refusing problem gamblers
16088167|NCT02250573|Biological|Replenine®-VF (High Purity Factor IX)|
16088168|NCT02250560|Biological|Replenine®-VF (High Purity Factor IX)|
16088169|NCT02250534|Other|Very low nicotine content cigarettes|
16088170|NCT02250521|Device|McGrath MAC enhanced direct laryngoscope|"The McGRATH® MAC enhanced direct laryngoscope (EDL) combines the familiarity of direct laryngoscopy with an inline video camera for an enhanced view.
~All 100 patients will be intubated using the McGRATH® MAC video laryngoscope, either through direct or indirect vision laryngoscopy. The LCD monitor of the McGRATH™ MAC was initially covered; if the anesthesiologist visualized a modified C-L grade 1-3 view, the patient was intubated utilizing this direct view. If the anesthesiologist observed a modified C-L grade 4 view during their initial direct view, the patient was intubated using the indirect method. If intubation via direct laryngoscopy was unsuccessful on the first attempt, the patient was intubated using the indirect view. If both methods of laryngoscopy were unsuccessful, the rescue intubation technique was performed at the discretion of the anesthesiologist."
16088171|NCT02250508|Biological|Optivate® (Human Coagulation Factor VIII)|
16088172|NCT02250508|Biological|Haemate P® (Human Coagulation Factor VIII)|
16088173|NCT02250495|Device|Sympara Therapeutic System|Sympara Therapeutic System as a non-invasive, fully reversible alternative for the treatment of hypertension
16088174|NCT02250482|Biological|Optivate® (Human Coagulation Factor VIII)|
16088175|NCT02250469|Device|Treatment with the Axium SCS system|
16088176|NCT02250469|Device|Treatment with the Medtronic SCS System|
16088177|NCT02250456|Procedure|Echo doppler|vascular ultrasound explorations
16088178|NCT02250443|Drug|BYM338 (Bimagrumab)|
16088179|NCT02250430|Drug|SB204|Applied topically twice a day on days 1, 2 and 3 to left and right cheeks
16088180|NCT02250417|Other|Wave sleep surface|The Wave sleep surface is designed to be used as a bed surface and with any combinations of sleep pillows, bed linens, and bed clothes and intended to avoid the supine position during sleep.
16088181|NCT02250404|Other|cytology specimen collection procedure|Correlative studies
16088182|NCT02250404|Other|laboratory biomarker analysis|Correlative studies
16088183|NCT02250391|Drug|NPB-06|5 days continuous-infusion
16088184|NCT02250391|Drug|Placebo|5 days continuous-infusion
16088185|NCT02250378|Radiation|stereotactic radiosurgery|Undergo stereotactic radiosurgery
16088186|NCT02250378|Procedure|therapeutic conventional surgery|Undergo wedge resection
16088187|NCT02250378|Other|laboratory biomarker analysis|Correlative studies
16088188|NCT02250378|Other|quality-of-life assessment|Ancillary studies
16088189|NCT02250365|Other|Continuous, suprasensory ESS|1 hour of ESS daily from Monday to Sunday during hospitalization, but no longer than 4th week post-stroke. The ESS will be applied immediately prior to OT/PT training which will include 15 minutes of repetitive, task-oriented upper limb training during the first 30 minutes after cessation of ESS.
16088190|NCT02250365|Other|Intermittent, suprasensory ESS|1 hour of ESS daily from Monday to Sunday during hospitalization, but no longer than 4th week post-stroke. The ESS will be applied immediately prior to OT/PT training which will include 15 minutes of repetitive, task-oriented upper limb training during the first 30 minutes after cessation of ESS.
16088191|NCT02250352|Other|cytology specimen collection procedure|Correlative studies
16088192|NCT02250339|Other|LAKU family program|Multi-systemic and multicomponent family-based intervention program
16088193|NCT02250339|Other|Etä-LAKU family program|Ecosystem-based intervention for families living in rural parts of Finland
16088194|NCT02250339|Other|Family therapy|Treatment as usual (TAU)
16088195|NCT02250326|Drug|nab-paclitaxel IV|nab-Paclitaxel intravenous (IV) infusion
16088196|NCT02250326|Drug|CC-486|Oral CC-486
16088197|NCT02250326|Drug|Duravalumab|
16088198|NCT02250300|Drug|MLN9708|2.3 mg, 3.0 mg or 4.0
16088199|NCT02250274|Biological|LAIV|Licensed and approved Live Attenuated Influenza Vaccination (LAIV) will be preferentially given to all children aged 5-8 years old as recommended by Advisory Committee on Immunization Practices. A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given LAIV will be used. The rest of the children aged 9-17 years old will receive IIV.
16088200|NCT02250274|Biological|IIV|"A modified randomization scheme in which every other child aged 9-17 years enrolled in the study will be given IIV will be used. The rest of the children 9-17 years old will receive LAIV.
~[Note: Although we do not anticipate exhausting the supply of LAIV, should this occur, children aged 5-8 will be offered IIV as it is also approved in this age group and should be used if LAIV is unavailable.]"
16088201|NCT02250261|Behavioral|KÄPY|
16088202|NCT02250248|Biological|AttraX Putty|
16088203|NCT02250248|Other|Iliac Crest Bone Graft (ICBG)|
16088204|NCT02250235|Other|Health risk information|
16088205|NCT02250222|Drug|LGD-6972|LGD-6972 sodium salt powder in Captisol ® (betadex [β-cyclodextrin] sulfobutylether sodium, NF)
16088206|NCT02250222|Drug|Placebo (Captisol ®)|betadex [β-cyclodextrin] sulfobutylether sodium, NF
16088207|NCT02250209|Drug|Trastuzumab|Trastuzumab is given by intravenous infusion at 440mg on day 0every 3 weeks. Number of cycles: 14~16 cycles.
16088208|NCT02250209|Drug|Capecitabine|"Capecitabine 800~1000 mg/m² is given orally twice a day for 14 days followed by a 1-week rest.
~Number of cycles: 8 cycles."
16088209|NCT02250209|Drug|Oxaliplatin|"Oxaliplatin is given by intravenous infusion at 130 mg/m2 on day 1 every 3 weeks.
~Number of cycles: 8 cycles."
16088210|NCT02250196|Drug|PEG-Asc|received 1 L solution of PEG-Asc at 7 p.m the evening before colonoscopy and another 1 L solution of PEG-Asc at 5 hours before procedure
16088211|NCT02250196|Drug|SPMC 2|received one sachet of SPMC at 7 p.m the evening before colonoscopy and another sachet of SPMC at 5 hours before procedure
16088212|NCT02250183|Device|MEDIHONEY® GEL WITH ACTIVE LEPTOSPERMUM HONEY|MEDIHONEY® GEL WITH ACTIVE LEPTOSPERMUM HONEY dressing is manufactured by the company Derma Sciences, Inc. and is a moist dressing made of Active Leptospermum Honey (+15) in combination with natural gelling agents. The gelling agents act to maintain the physical integrity and viscosity of the dressing, even in the presence of body heat and fluids. As a percentage of the overall dressing, MEDIHONEY® GEL dressings contains 80% honey. The dressing has a low pH and can help to lower the overall pH of wounds. The dressing also possesses a high osmotic potential, which assists in debridement.
16088213|NCT02250183|Device|Santyl|SANTYL® Ointment is an FDA-approved sterile enzymatic debriding ointment which contains 250 collagenase units per gram of white petrolatum USP. The enzyme SANTYL® is derived from the fermentation by Clostridium histolyticum. It possesses the unique ability to digest collagen in necrotic tissue. SANTYL® Ointment is indicated for debriding chronic dermal ulcers and severely burned areas.
16088214|NCT02250170|Drug|OPB-111077|Tablet, Oral, 300mg/500mg/700mg/900mg 4 days-on & 3 days-off (21 days=1cycle)
16088215|NCT02250157|Drug|Oratecan|
16088216|NCT02250144|Device|Foot orthoses|
16088217|NCT02250131|Procedure|Perfusion targeted at oxygen delivery|Flow on cardiopulmonary bypass based on a target oxygen delivery > 280 mL/min/m2
16088218|NCT02250118|Drug|Bevacizumab|Intrapleural Bevacizumab
16088219|NCT02250105|Drug|ARI-3037MO|Lipid lowering
16088220|NCT02250105|Drug|Placebo|Inactive
16088221|NCT02250092|Device|Transcranial Direct Current Stimulation (tDCS)|10 tDCS/CIMT Sessions
16088222|NCT02250092|Device|Placebo Comparator|
16088223|NCT02250079|Device|polyethylene plastic bag|Inborn neonates with both a gestational age >29 weeks were randomized 1:1 to either a standard thermoregulation protocol or placement of a Poliethylene body bag since birth to 10 minutes after birth.
16088224|NCT02250079|Device|Conventional treatment|Infants randomized to the control group received standard hospital care newborn. This included immediate drying, skin-to-skin contact, early and exclusive breast feeding, postponed bathing, bundling, and radiant warmer. While waiting for criteria cord clamping, the environment humidity and temperature and segment and rectal temperature of the newborn were measure. It was repeated at 1-5- 10-60 and 120 minutes. After clamping, the newborn were positioned in a radiant warmer, and completed the drying process. Umbilical prophylaxis, vitamin K1 application, initial physical examination and ocular prophylaxis are performed. The infants were swaddled in blankets provided by the mother, the head was covered with a hat, and the infants were placed either in an open crib or under a radiant warmer as necessary and available. The same process was done in surgery room in case of cesarean.
16088225|NCT02250066|Other|Diet|Study group 1 received high monounsaturated fat diet Study group2 received high carbohydrate diet Control group was encouraged to follow the Food Guide Pyramid
16088226|NCT02250053|Other|Exercise|
16088227|NCT02250040|Other|Conventional physiotherapy|Physiotherapy techniques that included muscle training, stretching and endurance.
16088228|NCT02250040|Other|Techniques based on patients' functional level were added.|The added techniques aimed to improve balance and movement dissociation.
16088229|NCT02250027|Drug|HL301 300mg capsule|2 capsules at once, 3 times a day, for 7 days
16088230|NCT02250027|Drug|Placebo|2 capsules at once, 3 times a day, for 7 days
16088231|NCT02250014|Procedure|cryotherapy|Undergo cryotherapy
16088232|NCT02250014|Biological|sargramostim|Given subcutaneously
16088233|NCT02249988|Drug|ABX203 therapeutic Hepatitis B vaccine treatment arm|
16088234|NCT02249975|Device|C2 CryoBalloon Focal Ablation System|"The C2 Focal Cryoablation Device will be used for the treatment of islands of BE in real patient care. Ablation at 10 seconds will be tested and post-ablation symptoms related to the Cryoballoon Focal Ablation will be recorded. At 12 weeks, the patient will receive a follow-up endoscopy and biopsy samples will be taken.
~Biopsy samples will be evaluated for the presence of residual Barrett's Esophagus. Through evaluation of the histological results, treatment parameters for the ablation of human esophageal epithelium will be better understood.
~Evaluations include, but are not limited to the following:
~Device malfunctions
~Adverse events
~Patient Pain
~Histological evaluation of treatment zone at 12 weeks for presence of residual Barrett's Esophagus."
16088235|NCT02249949|Drug|efatutazone|Given PO
16088236|NCT02249936|Drug|AZD1722|
16088237|NCT02249936|Drug|Omeprazole|
16088238|NCT02249910|Drug|semaglutide|Oral administration of 5 mg daily for one week, then escalated to 10 mg daily for one week, followed by escalation to 20 mg daily for 41 days
16088239|NCT02249910|Drug|metformin|Oral administration of 850 mg twice daily for 3 days followed by 850 mg on day 4, assessed in 3 dosing periods 1) alone, 2) co-administration with SNAC (sodium N-[8-(2-hydroxybenzoyl) amino] caprylate) and 3) co-administration with oral semaglutide.
16088240|NCT02249910|Drug|digoxin|Oral administration of 0.5 mg single dose, assessed in 3 dosing periods 1) alone, 2) co-administration with SNAC (sodium N-[8-(2-hydroxybenzoyl) amino] caprylate) and 3) co-administration with oral semaglutide.
16088241|NCT02249910|Drug|placebo|Oral administration of SNAC 300 mg. Will be administered with the morning dose of metformin (1st, 3rd, 5th and 7th dose). On Day 24, a single SNAC dose will be administered with digoxin.
16088242|NCT02249897|Drug|CHOLESTYRAMINE|CHOLESTYRAMINE CAPSULES, 6 G/DAY P.O. DURING 12 WEEKS
16088243|NCT02249884|Drug|Urea Dose A|Urea cream for topical use.
16088244|NCT02249884|Drug|Urea Dose B|Urea cream for topical use.
16088245|NCT02249884|Drug|Urea Dose C|Urea cream for topical use.
16088246|NCT02249884|Drug|Chamomile Dose A|Chamomile gel for topical use.
16088247|NCT02249884|Drug|Chamomile Dose B|Chamomile gel for topical use.
16088248|NCT02249884|Drug|Chamomile Dose C|Chamomile gel for topical use.
16088249|NCT02249871|Drug|semaglutide|All subjects will be treated for 10 consecutive days including dose escalation, with 5 days on 5 mg oral semaglutide followed by 5 days on 10 mg oral semaglutide.
16088250|NCT02249871|Drug|Omeprazole|Will be given daily with oral semaglutide.
16088251|NCT02249858|Procedure|Cranial Vault Hold|
16088252|NCT02249858|Procedure|Cervical HVLA|
16088253|NCT02249832|Device|seated robot-assisted ankle therapy|The MIT anklebot provides over one thousand total dorsi/plantar flexion and inversion/eversion robot-assisted movements of the ankle while in a seated position.
16088254|NCT02249819|Device|transcranial direct current stimulation|Soterix 1x1 anodal tDCS
16088255|NCT02249806|Other|PH target therapy according to physician|Patients receiving PH target therapy
16088256|NCT02249780|Procedure|Postoperative parathyroid function test|Calcium and parathormone dosage at 24 hours and ten day after surgery
16088257|NCT02249780|Procedure|No postoperative parathyroid dosage and supplementation|The patients will be clinically followed for 24 hours after surgery and caclium and parathormone dosage will be done at ten days after surgery. No supplementation will be given.
16088258|NCT02249780|Procedure|ICG parathyroid angiography|Injection of 3,5 mL of indocyanine green intravenously and perform angiography of parathyroid glands after thyroid removal.
16088259|NCT02249780|Drug|Parathyroid supplementation|Supplementration with Calcimagon D3 Forte (1gr Calcium and 800 IU of 25-OH-vitamin D) from surgery day to up to 10 days afeter surgery.
16088260|NCT02249767|Drug|Tretinoin|Treatment of acne once daily in evening
16088261|NCT02249754|Behavioral|Nutrition education|This group will receive the nutrition education package. The package is composed of: 1) education and counselling of mothers when the child is aged 6 (baseline), 9 and 12 months; 2) training community-based nutrition counsellors at baseline and 12 months and monthly home visits, 3) supervision of community-based nutrition counsellors' work every 2 months, and 4) sensitisation meetings with family members and health staff responsible for child health at baseline and repeated at 12 months. In addition, the group will continue to attend routine health education given at health facilities every month.
16088262|NCT02249754|Behavioral|Routine health education|This group will receive routine health education every month. It is a standard government health service offered monthly in all health facilities by health staff. It is given to mothers of children below the age of five years during growth monitoring and immunisation contacts. The sessions take 10-15 minutes focusing on general health issues including child feeding, prevention of diseases such as malaria and importance of immunisations.
16088263|NCT02249741|Drug|Treated with Ibandronic acid as per protocol|treated with Ibandronic acid at a dose of 150 mg once a month for six months
16088264|NCT02249728|Drug|IV PBT2 microtracer and oral PBT2 single dose|
16088265|NCT02249728|Drug|oral 14C-PBT2|
16088266|NCT02249715|Device|Brainsway Multiway deep TMS device (two channels)|
16088267|NCT02249702|Drug|gemcitabine + docetaxel|
16088268|NCT02249702|Drug|trabectedin|
16088269|NCT02249689|Other|Definitive 65|
16088270|NCT02249689|Other|Definitive 74|
16088271|NCT02249676|Biological|Autologous mesenchymal stem cells|Autologous mesenchymal stem cells
16088272|NCT02249663|Drug|Azelastine hydrochloride and Fluticasone propionate|137/50 mcg Nasal Spray
16088273|NCT02249663|Drug|Dymista™|137/50 mcg Nasal Spray
16088274|NCT02249663|Other|Placebo|Nasal spray with no pharmaceutically active content
16088275|NCT02249650|Drug|TSB-9-W1|Product name: TSB-9-W1 Unit dose: 100 mg per capsule Dosage form: Capsule Treatment cycle: A treatment cycle consists of 2-day on-dose oral administering and followed by a 3-day off-dose.
16088323|NCT02249325|Dietary Supplement|Probiotic dietary supplement|Florajen3 is a commercially available probiotic supplement containing three bacteria of human origin (>7.5 x10^9 L. acidophilus, >6.0 x10^9 .B. lactis, and >1.5 x10^9 B .longum). Once capsule was administered daily by mouth from 28 through 36 weeks gestation.
16088324|NCT02249312|Drug|BIIL 284 BS|
16088325|NCT02249312|Drug|Placebo|
16088326|NCT02249299|Drug|Sativex Oromucosal Spray|Sativex Oromucosal Spray (GW Pharma Ltd, Salisbury. UK). Each 100 microlitre spray contains: 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD).
16088276|NCT02249637|Procedure|Novel technique Circumcision Incision Orchidopexy|The novel technique starts with retraction of the prepucial skin off the glans penis and double incision circumcision done with mucosal sparing, then degloving of the penis on the side of the undescended testis. Dissection via Dartos' layer into the inguinal area until the palpable testicle was identified and extracted with mobilization of the spermatic cord. Hernia sac was then separated and suture ligated as high as the area of internal ring opening. Spematic cord lengthening was done until adequate length achieved for fixation into the inferior aspect of the scrotum. Then development of the Dartos' pouch via the circumcision site was done. A double or single suture testicular fixation using Vicryl 3-0 simple interrupted sutures on the everted Dartos' pouch inner surface was done. Subsequent placement of the testicle into the Dartos' pouch was done as the inner surface was inverted. The last step was the completion of the circumcision closure using Chromic 4-0 interrupted sutures.
16088277|NCT02249611|Device|Mobile physical activity promotion tool|"Mobile activity sensor
~Smartphone with APP
~Interactional webpage of internet
~Evidence based health information
~Individualized reminding messages according to the data from activity recording system
~Personal counseling from professional personnel"
16088278|NCT02249611|Other|Standard care|Counseling on lifestyles with health education material
16088279|NCT02249598|Biological|lactamica|
16088280|NCT02249598|Biological|Placebo|
16088281|NCT02249585|Device|Standard abdominal pressure|Abdominal pressure maintained 12mmHg throughout laparoscopic colon surgery
16088282|NCT02249585|Device|Low abdominal pressure|Abdominal pressure maintained 8mmHg throughout laparoscopic colon surgery
16088283|NCT02249585|Drug|Conventional neuromuscular blockade|Anesthesia induction with rocuronium 0.4mg/kg and maintenance with rocuronium 0.15mg/kg to maintain TOF 1-2 twitch
16088284|NCT02249585|Drug|Deep neuromuscular blockade|Anesthesia induction with rocuronium 0.8mg/kg → maintenance with rocuronium 0.3mg/kg to maintain PTC 1-2 twitch
16088285|NCT02249572|Radiation|gamma knife radiosurgery|Leksell Perfection model gamma knife.
16088286|NCT02249546|Drug|N-acetylcysteine + PPI-amoxicillin-clarithromycin|
16088287|NCT02249546|Drug|PPI-amoxicillin-clarithromycin|Triple therapy
16088288|NCT02249533|Other|Spot Light Concussion App|Certified Athletic Trainers will report football injuries using High School RIO and will report possible concussions using the Spot Light concussion app.
16088289|NCT02249520|Other|PET-MR imaging on Biograph mMR scanner|Participants will undergo PET-MR imaging on the Biograph mMR scanner to evaluate the technical aspects of the total acquisition protocol directly post clinical administration of FDG, thus removing the requirement for additional radioisotope.
16088290|NCT02249520|Other|MR-only imaging on Biograph mMR scanner|Participants will undergo MR-only imaging to test the technical aspects of the MR-only protocol on the Biograph mMR scanner. No drug administered.
16088291|NCT02249520|Other|MR imaging on the Siemens Vida 3T MR scanner|Participants will undergo MR imaging to test the technical aspects of the MR protocol on the Vida MR scanner
16088292|NCT02249507|Other|aerobic exercise|aerobic exercise (cycloergometer) at selected intensity (HRmax or equivalent)
16088293|NCT02249494|Other|telehealth|Use the call service offered by the Center for Telehealth Rio Grande do Sul to answer clinic questions with qualified staff and in real time. All physicians who work in Primary Health Care in Brazil can call when they have questions about diagnosis and management of their patients.
16088294|NCT02249494|Other|nutritional counseling|Performing routine nutritional counseling in their clinical practice
16088295|NCT02249494|Device|smartphone (mobile app)|Mobile app, designed to provide nutritional recommendations for hypertensive patients, will be use. The recommendations will be based on the DASH diet guidelines appropriate to the patient profile: consumption of whole grains, fruits, vegetables, milk or low fat dairy products, lean meats, poultry and fish, nuts, seeds and legumes, amount of fats, oils and sweets, as well as guidelines for salt intake and alcohol.
16088296|NCT02249481|Procedure|Adductor Canal catheter delivering 0.0625% L- Bupivacaine|Adductor canal catheter: Blockade at mid-thigh. Identify sartorius at mid thigh - find point where the femoral artery begins to descend from sartorius. In plane technique, hydro-dissect space between sartorius and femoral artery. Catheter threaded and 2-4cm left in situ (bevel orientated cephalad). Bolus 20 mls via needle and 5 mls via catheter to confirm spread under ultrasound guidance. Glue/Lockit dressing.
16088297|NCT02249481|Procedure|Femoral nerve catheter delivering 0.0625% L- Bupivacaine|Femoral nerve catheter: Blockade at level of Femoral crease. Identify femoral nerve. In plane lateral approach. Bolus 20 mls via needle. Catheter threaded and 2-4cm left in situ (bevel orientated cephalad).and 5 mls injected via catheter to confirm spread under ultrasound guidance. Glue/Lockit dressing.
16088298|NCT02249455|Device|Acapella|Treatment time for 20 min twice daily
16088299|NCT02249455|Other|ELTGOL|ELTGOL technique 20 min twice daily
16088300|NCT02249455|Other|conventional physiotherapy|Conventional physiotherapy was given twice daily for 20 min
16088301|NCT02249442|Drug|Tipranavir (TPV)|
16088302|NCT02249442|Drug|Ritonavir (r)|
16088303|NCT02249429|Drug|bimiralisib|60 mg or 80 mg bimiralisib per oral (p.o.) once daily or intermittent dosing (120mg,140mg and 160mg) until unacceptable AE, disease progression, patient's request for withdrawal, investigator judgement or death - whichever comes first.
16088304|NCT02249416|Drug|Tipranavir (TPV) low|
16088305|NCT02249416|Drug|Ritonavir (RTV) low|Norvir®
16088306|NCT02249416|Drug|Tipranavir (TPV) high|Retrovir®
16088307|NCT02249416|Drug|Ritonavir (RTV) high|
16088308|NCT02249416|Drug|Zidovudine|
16088309|NCT02249403|Drug|Talsaclidine 6 mg|
16088310|NCT02249403|Drug|Talsaclidine 12 mg|
16088311|NCT02249403|Drug|Talsaclidine 24 mg|
16088312|NCT02249403|Drug|Talsaclidine 36 mg|
16088313|NCT02249403|Drug|Placebo|
16088314|NCT02249377|Other|Platelets-Rich-Plasma|Platelet-Rich Plasma
16088315|NCT02249377|Drug|Corticosteroid|Corticosteroid
16088316|NCT02249364|Procedure|Control|Routine practice
16088317|NCT02249364|Procedure|Hypnosis|Hypnosis session before induction of anesthesia
16088318|NCT02249364|Drug|propofol|Closed-loop administration of propofol for anesthesia induction
16088319|NCT02249351|Drug|Talsaclidine|
16088320|NCT02249351|Drug|Placebo|
16088321|NCT02249338|Drug|BIIL 284 BS|
16088322|NCT02249338|Drug|Placebo|
16088328|NCT02249286|Behavioral|Child Centered Nutrition Counseling|The intervention comprises child-centered nutrition counseling for caretakers and support for 'developed' gardens and improved backyard poultry production; whereas the control will only receive the agriculture extension and the existing health and nutrition education in the area
16088329|NCT02249286|Other|no intervention|the control will only receive the agriculture extension and the existing health and nutrition education in the area
16088330|NCT02249273|Other|Diagnostic approaches|General practitioners will register the diagnostic process in patients with a suspected urinary tract infection
16088331|NCT02249260|Behavioral|High intensity interval training|Group-based high-intensity aerobic interval training and lifestyle counseling
16088332|NCT02249247|Drug|Low dose of BIIL 284 BS tablets|
16088333|NCT02249247|Drug|Medium dose of BIIL 284 BS tablets|
16088334|NCT02249247|Drug|High dose of BIIL 284 BS tablets|
16088335|NCT02249247|Drug|Placebo|
16088336|NCT02249234|Drug|Botox|
16088337|NCT02249234|Drug|Placebo|
16088338|NCT02249221|Biological|Quadrivalent cell-culture based influenza vaccin|GC3106, 0.5ml, intramuscular, a single dosing at Day 1
16088339|NCT02249221|Biological|Trivalent influenza vaccine|GC Flu Pre-filled Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1
16088340|NCT02249208|Device|Tc+blue dye|Sentinel Lymph Node (SLN) identification and resection using the standard technique of sub-areolar injection of technetium-99m (Tc-99m) and sub-areolar injection of vital blue dye before surgery
16088341|NCT02249208|Device|Tc+SPIO|Sentinel Lymph Node (SLN) identification and resection using isotope technique of sub-areolar injection of technetium-99m (Tc-99m) and the magnetic technique with the sub-areolar injection of SPIO (Sienna+®), before surgery
16088342|NCT02249208|Device|SPIO alone|Sentinel Lymph Node (SLN) identification and resection using the magnetic technique with the sub-areolar injection of SPIO (Sienna+®) before surgery
16088343|NCT02249182|Drug|LDV/SOF|LDV/SOF FDC administered orally once daily
16088344|NCT02249182|Drug|RBV|Ribavirin (RBV) oral solution or capsules will be administered orally in a divided daily dose based on weight
16088345|NCT02249156|Behavioral|Financial incentive for choosing a lower-cost provider|Employees of the intervention group receive money (either as a payment to their health savings account or directly as a check) if they obtain a radiology test or laboratory test from what a low-cost or rewards provider. The amount of money per test varies by the employer and type of test. A provider is identified as low-cost or rewards if their costs are in the lowest 10-20% among all providers in the community. Again there is a range because the relative cutoff has varied across the employers that have implemented this program.
16088346|NCT02249143|Device|CPAP and room air|Stable premature infants on CPAP and room air and meeting specific stability criteria will be randomized to stay on continuous positive airway pressure and room air for an additional two weeks or will be transitioned to room air alone.
16088347|NCT02249130|Drug|Tipranavir (TPV)|
16088348|NCT02249130|Drug|Ritonavir (RTV)|
16088349|NCT02249130|Drug|Delavirdine (DLV)|
16088350|NCT02249130|Drug|Zidovudine (ZDV)|
16088351|NCT02249130|Drug|Lamivudine (3TC)|
16088352|NCT02249130|Drug|Stavudine (d4T)|
16088353|NCT02249117|Drug|BIWH 3|
16088354|NCT02249117|Drug|Placebo|
16088355|NCT02249104|Drug|Adapalene/benzoyl peroxide gel, 0.1%/2.5%|Topical AV therapy
16088356|NCT02249104|Other|Cetaphil Acne Regimen|Cleanse, Moisturize, and Protect
16088357|NCT02249091|Drug|Selinexor|Patients receive Selinexor as specified in arm/group description (8 doses of 40 mg/m^2 or 6 doses of 60 mg per induction cycle).
16088358|NCT02249091|Drug|Idarubicin|Infusion, iv, 10 mg/m^2, on days 1,3,5 in cycle 1, on days 1,3 in cycle 2
16088359|NCT02249091|Drug|Cytarabine|Continuous infusion day 1 to 7, 100 mg/m^2, iv,
16088360|NCT02249078|Drug|E6011|E6011 solution for injection
16088361|NCT02249078|Drug|Placebo|Placebo 2-mL vial solution for injection
16088362|NCT02249065|Drug|Brimonidine|
16088363|NCT02249052|Drug|AA4500|Subjects must present with 2 lipomas; one to receive AA4500 and one to receive placebo simultaneously
16088364|NCT02249052|Drug|placebo|Placebo
16088365|NCT02249039|Drug|intermittent IV CLON|Mechanically ventilated infants and children receive intravenous intermittent Clonidine instead of dexmedetomidine
16088366|NCT02249026|Drug|BZDs + opiate exposure treated with BPN|These infants will have been exposed not only to opiates but also to BZDs during pregnancy. Administration of Buprenorphine: The solution will be administered under the tongue followed by the insertion of a pacifier to reduce swallowing. Dose volumes greater than 0.5 mL will be given in 2 aliquots separated by 2 minutes allowing time for the drug to be absorbed. If the infant's withdrawal is not controlled, clonidine will be used as adjunct therapy. The initial dose of clonidine is 6 mcg/kg/day in 4 divided doses given every 6 hours. If signs of withdrawal are not controlled, the dose may be increased by 3mcg/kg/day to a maximum 12 mcg/kg/day divided q 6 hrs.
16088367|NCT02249026|Drug|Opiates exposure treated with BPN|These infants will have been exposed not only to opiates during pregnancy. Administration of Buprenorphine: The solution will be administered under the tongue followed by the insertion of a pacifier to reduce swallowing. Dose volumes greater than 0.5 mL will be given in 2 aliquots separated by 2 minutes allowing time for the drug to be absorbed. If the infant's withdrawal is not controlled, clonidine will be used as adjunct therapy. The initial dose of clonidine is 6 mcg/kg/day in 4 divided doses given every 6 hours. If signs of withdrawal are not controlled, the dose may be increased by 3mcg/kg/day to a maximum 12 mcg/kg/day divided q 6 hrs.
16088368|NCT02249013|Procedure|Cytoreductive Surgery (CRS)|CRS was performed with standard peritonectomy procedures and visceral resections directed towards complete elimination of tumors from the abdominopelvic cavity.
16088369|NCT02249013|Procedure|Hyperthermic Intraperitoneal Chemotherapy (HIPEC)|HIPEC was performed according to the closed-abdomen technique using CDDP (25 mg/L of perfusate/m2, total limit of 240mg) for the first 10 patients and thus, using CDDP plus Doxorubicin (15mg/L) thereafter, both for 30 minutes, with an intra-abdominal target temperature of 41-43°C. Perfusate (2L/m2, ranging from 4L to 6L) was circulated using an extracorporeal circulation device (Performer HT; RAND, Medolla, Italy) at a flow rate of 700 ml/min.
16088460|NCT02248376|Drug|Gel|Patients aged of more than 18 years-old coming for a natural miscarriage who will have the stick gel application at the end of the scraping surgery.
16088370|NCT02249013|Drug|Neoadjuvant Chemotherapy (NACT)|Systemic chemotherapy included the standard combination of carboplatin (AUC 6) and paclitaxel (175 mg/m2) administered every 21 days as neoadjuvant (2-4 cycles) plus adjuvant regimens (2-4 cycles), in the total of 6 cycles of systemic chemotherapy.
16088371|NCT02249013|Drug|Adjuvant Chemotherapy|Systemic chemotherapy included the standard combination of carboplatin (AUC 6) and paclitaxel (175 mg/m2) administered every 21 days as neoadjuvant (2-4 cycles) plus adjuvant regimens (2-4 cycles), in the total of 6 cycles of systemic chemotherapy.
16088372|NCT02249013|Procedure|Fast-track recovery strategy|A comprehensive fast-track program was applied to accelerate recovery, reduce morbidity, and shorten convalescence for patients enrolled in our trial.
16088373|NCT02249000|Device|BIOVALVE prosthesis|Transcatheter Aortic Valve Replacement (TAVR)
16088374|NCT02248987|Other|patients treated with antipsychotics|
16088375|NCT02248974|Other|LVAD Decision Aid|"Decision aids are interventions or tools designed to facilitate shared decision making and patient participation in health care decisions.
~This Decision Aid was designed to discuss treatment options for patients in end-stage heart failure (i.e LVAD PLACEMENT, PALLIATIVE and SUPPORTIVE CARE)."
16088376|NCT02248961|Drug|Fimasartan|"Starting dose of Kanarb (Fimasartan) is 60 mg, orally, once a day in the morning. The subjects will visit the clinical site every 4 weeks to measure Arterial blood pressure (ABP). The dose will be doubled in case if SBP ≥140 mmHg or DBP ≥90 mmHg at Visit 3 (Day 28) or at Visit 4 (Day 56).
~If necessary, the dose of the study drug may be increased based on the assessment of patient's condition performed at the phone contact (Day14±3). Patient may be called for an unscheduled visit for treatment adjustment (decided individually, with possibility of dose titration as per investigator's judgment, indicated in source documents).
~When possibilities are, the patient should be administrated by the study medication at the same time in the morning."
16088377|NCT02248961|Drug|Losartan|Cozaar® (Losartan), manufactured by MERCK SHARP & DOHME B.V., Netherlands, tablets 50/100 mg
16088378|NCT02248948|Dietary Supplement|Omega-3 Fatty Acids|Patients will receive a daily dose calculated based on the child weight (≤28 kg=4ml; 29-40 kg= 6ml and ≥41 kg=8ml) and will be provided once a day for 6 months.
16088379|NCT02248948|Dietary Supplement|Medium Chain Triglycerides|Patients will receive a daily dose calculated based on the child weight (≤28 kg=4ml; 29-40 kg= 6ml and ≥41 kg=8ml) and will be provided once a day for 6 months.
16088380|NCT02248922|Drug|TIS or TIP|300mg nebulized Tobramycin (Tobramycin inhalation solution(TIS)) or TOBI Podhaler (Tobramycin inhalation powder(TIP), equivalent dry powder)
16088381|NCT02248896|Drug|Telmisartan|
16088382|NCT02248896|Drug|Other angiotensin-receptor blockers (ARBs)|
16088383|NCT02248896|Drug|Angiotensin-converting enzyme inhibitors (ACEIs)|
16088384|NCT02248896|Drug|Other major antihypertensive medication classes|e.g. beta-blockers, calcium channel blockers (CCBs), diuretics
16088385|NCT02248883|Drug|TPV low|
16088386|NCT02248883|Drug|Placebo|
16088387|NCT02248883|Drug|Moxifloxacin|
16088388|NCT02248883|Drug|TPV high|
16088389|NCT02248883|Drug|RTV|
16088390|NCT02248870|Drug|Dexamethasone|Dexamethasone is added to Bupivacaine with Adrenaline for perineural injection
16088391|NCT02248870|Drug|Saline|Saline is added as a placebo to Bupivacaine with adrenaline for perineural injection
16088392|NCT02248857|Other|UMS Strategy|Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.
16088393|NCT02248857|Other|SMS Texting Reminders|In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.
16088394|NCT02248844|Biological|Botulinum Toxin Type A|Botulinum toxin Type A injected into crow's feet line areas per clinical practice.
16088395|NCT02248831|Device|Recording Doppler ultrasound signals noninvasively|Using ultrasound noninvasively and recording Doppler signals from the right chest wall
16088396|NCT02248818|Drug|AZD8108|Drug: AZD8108 Single or Multiple doses administered orally as a solution.
16088397|NCT02248818|Drug|Placebo|Placebo to match AZD8108 Single or Multiple doses of matching placebo administered orally as a solution
16088398|NCT02248805|Drug|MGD007|MGD007 is a gpA33 x CD3 bi-specific antibody-based molecular construct referred to as a DART molecule. MGD007 will be administered as a single agent.
16088399|NCT02248792|Drug|Methotrexate|
16088400|NCT02248766|Device|somofilcon A|somofilcon A lens
16088401|NCT02248753|Drug|Pharmacological cardioversion - Flecainide|
16088402|NCT02248753|Procedure|Electrical cardioversion|
16088403|NCT02248753|Drug|Metoprolol|
16088404|NCT02248753|Drug|Verapamil|
16088405|NCT02248753|Drug|Digoxin|
16088406|NCT02248753|Drug|Pharmacological cardioversion - Amiodarone|
16088407|NCT02248740|Procedure|Ablation of the incompetent small saphenous vein|For each patient, the Small Saphenous Vein (SSV) will be accessed from the midcalf. After liberal use of tumescent anesthesia, ablation of the incompetent small saphenous vein will be performed. Half the patients will have this procedure performed using the Laser Ablation device and half will be performed using the Radiofrequency Ablation device. They will be randomly assigned to treatment.
16088408|NCT02248727|Device|somofilcon A|somofilcon A lens
16088409|NCT02248714|Dietary Supplement|Glucerna SR|Glucerna SR (Abbott Laboratories, Columbus, USA) is a nutritional product with lower glycemic response.
16088410|NCT02248701|Drug|testosterone enanthate, finasteride|Subjects receive testosterone (125 mg/week) by intramuscular injection and finasteride (5 mg/day) orally
16088411|NCT02248701|Drug|placebo|Subjects receive weekly placebo injection and placebo pill daily
16088412|NCT02248688|Device|BeadBlock 300 - 500 Micron|Beadblock will be used intraarterially to occlude the left gastric artery and its branches. The left gastric artery supplies the fundus of the stomach, where it is known that the hormone Ghrelin (one of the hormones responsible for appetite) is produced.
16088413|NCT02248688|Procedure|Left Gastric Artery Embolization|
16088414|NCT02248675|Behavioral|CBT-I|Cognitive Behavioral Therapy for Insomnia (CBT-I), an evidence-based insomnia treatment. In this study it will be delivered in four individual sessions.
16088489|NCT02248090|Drug|AZD9496|AZD9496
16088867|NCT02245256|Drug|Precedex|infusion of 0.1mcg/kg/hr of precedex
16088415|NCT02248675|Other|TAU|Treatment as Usual: All participants will be encouraged to begin or continue treatment of co-occurring conditions as recommended by treatment providers. This may include treatment within the primary care teams, through behavioral telehealth, and/or specialty outpatient mental health. Participants randomized to TAU may receive pharmacotherapy for insomnia, though CBT-I will be precluded until after the post-treatment assessments.
16088416|NCT02248649|Behavioral|Structured physical activity|Walking instruction and encouragement
16088417|NCT02248649|Behavioral|Health education|Provision of general information about a variety of health topics
16088418|NCT02248636|Drug|Cholinesterase inhibitor|This group receives a half-dose of their previous cholinesterase inhibitor medication (in overencapsulated form) for two weeks, then receives placebo.
16088419|NCT02248636|Drug|Sham discontinuation|This group receives their previous dose of cholinesterase inhibitor medication, but in overencapsulated form
16088420|NCT02248610|Other|Non-interventional study|
16088421|NCT02248597|Drug|fludarabine phosphate|Given IV
16088422|NCT02248597|Drug|busulfan|Given IV
16088423|NCT02248597|Drug|cyclophosphamide|Given IV
16088424|NCT02248597|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo myeloablative or reduced intensity allogeneic stem cell transplant
16088425|NCT02248597|Drug|tacrolimus|
16088426|NCT02248597|Drug|mycophenolate mofetil|
16088427|NCT02248584|Dietary Supplement|Vitamin C, E and Zinc|Capsule containing vitamin C (50 mg; CVS Quality, USA), vitamin E (60 mg; Nature´s Bounty, USA), and zinc (40 mg; CVS Quality, USA) per day for 60 days.
16088428|NCT02248571|Drug|Bevacizumab|administered as combined therapy with Capecitabine
16088429|NCT02248571|Drug|Capecitabine|administered as combined therapy with Bevacizumab
16088430|NCT02248571|Drug|Everolimus|administered as combined therapy with Exemestane
16088431|NCT02248571|Drug|Exemestane|administered as combined therapy with Everolimus
16088432|NCT02248571|Other|Patient questionaires|Patients will fill out questionaires at four specific time points during study treatment to assess patient reported outcome and patients' preference
16088433|NCT02248558|Behavioral|Conventional Video|Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was created by a local CDC via direct CDC funding and internal guidance and development.
16088434|NCT02248558|Behavioral|Crowdsourced Video|Participants will watch a one minute video whose purpose is to increase HIV testing uptake. This video was the winner in a crowdsourced video contest hosted in China. CBOs all submitted their own independently designed and funded videos.
16088435|NCT02248532|Biological|Stem cell therapy|Bone marrow cells will be mobilized into peripheral blood by daily subcutaneous injections of G-CSF (10 µg/kg daily) and collected by leukapheresis. Positive immunomagnetic selection of CD34+ cells will be performed. Electroanatomic mapping of the left ventricle will be performed using the Biosense NOGA system (Biosense-Webster®, Diamond Bar, CA). The target area for cell delivery will be defined as the myocardial segments with unipolar voltage potentials ≥8.3 mV, bipolar amplitudes >1.9 mV, and linear shortening <6%. Intramyocardial delivery of cell suspension will be performed with the MyoStar (BiosenseWebster®, Diamond Bar, CA) injection catheter. Each patient will receive 20 injections (0.3 mL each; total volume of 6 mL). All the procedures will be repeated 6 months after baseline.
16088436|NCT02248519|Procedure|Open Gastrectomy|Patients allocated to the 'Open Gastrectomy' group will receive distal or total gastrectomy via laparotomy. This group is considered the control group
16088437|NCT02248519|Procedure|Laparoscopic Gastrectomy|Patients allocated to the 'Laparoscopic Gastrectomy' group will undergo distal or total gastrectomy via laparoscopy. If laparoscopic resection does not seem feasible during surgery, the procedure may be converted to an open gastrectomy.
16088438|NCT02248506|Other|Clotrimazole|All patients receive standard antifungal treatment for this type of infections consisting Clotrimazole 500 Single dose (standard treatment).
16088439|NCT02248493|Drug|Paracetamol|
16088440|NCT02248493|Drug|Placebo (for paracetamol)|
16088441|NCT02248493|Drug|Ketoprofen|
16088442|NCT02248493|Drug|Tramadol|Administered on request as rescue medication in a dose 2 mg/kg IV up till 2 doses. No other opioid is given to these patients.
16088443|NCT02248493|Drug|Morphine|administered in patients receiving IV PCA with morphine postoperatively. No other opioid is given to these patients.
16088444|NCT02248480|Drug|Duloxetine|Administered orally
16088445|NCT02248480|Drug|Placebo|Administered orally
16088446|NCT02248454|Drug|Lispro|Increasing insulin doses
16088447|NCT02248441|Other|Daily ischemic conditioning treatment|RIC stimulus will be conducted as 4 x 5 minutes upper arm ischemia achieved by inflation of a blood pressure cuff to 200 mmHg and 5 minutes reperfusion between inflations. The procedure will be performed using the AutoRICTM (CellAegis Devices Inc., Toronto, Ontario, Canada).
16088448|NCT02248428|Drug|Clarithromycin|500mg orally daily on days 1-28,repeated every 28 days
16088449|NCT02248428|Drug|Thalidomide|Thalidomide 100-200mg orally per night on days 1-28,repeated every 28 days
16088450|NCT02248428|Drug|Cyclophosphamide|300mg/m^2 intravenously daily on day 1-3,repeated every 28 days
16088451|NCT02248428|Drug|Dexamethasone|40 mg orally weekly on days 1,8,15,22,repeated every 28 days
16088452|NCT02248415|Other|No pump|In the no pump group blood cardioplegia was delivered using the arterial line pressure, created by the arterial centrifugal pump of the cardiopulmonary bypass system. Blood cardioplegia flow depended on the difference between arterial line pressure and aortic root pressure.
16088453|NCT02248415|Other|Pump|In the pump group blood cardioplegia was delivered using a roller pump. The blood cardioplegia flow was given at 200 mL/min.
16088454|NCT02248415|Other|Blood sample collection: after induction of anaesthesia (T0)|The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.
16088455|NCT02248415|Other|Blood sample collection: after arrival at the ICU (T1)|The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.
16088456|NCT02248415|Other|Blood sample collection: 4 hours in ICU (T2)|The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.
16088457|NCT02248415|Other|Blood sample collection: the first postoperative day (T3)|The following biomarkers were analysed: TnT-hs, H-FABP, NT-pro-BNP and CRP.
16088458|NCT02248402|Biological|Vax-DC/MM|
16088459|NCT02248389|Device|Sonatherm 600i ablation system|HIFU ablation of tumor.
16088461|NCT02248363|Other|Multimodal rehabilitation|Multimodal rehabilitation (MMR) distinguishes itself as an interdisciplinary-coordinated (e.g., physician, occupational therapist, physiotherapist, and psychologist) intervention using a bio-psycho-social view of chronic pain. The MMR continues over a lengthy period with a common goal and generally includes patient education, supervised physical activity, simulated work training, and cognitive behavioural therapy (CBT). The exact composition of these MMR components depends on initial evaluations of the patients health status and furhter follow-up testing. The MMR interventional components can act independently and interdependently, resulting in combined effects due to known and unknown mechanisms; the effects are intended to be greater than the sum of its components.
16088462|NCT02248350|Behavioral|Supervised and Home Based Exercise|Participants will come to our community based research office for up to 50 min/session, 3-days/week of supervised exercise for 8-weeks. The exercise intensity will be tailored between 60-80% of their VO2max, as determined during baseline testing and with a rating of perceived exertion (RPE) of 11-14 on the 20-point scale.
16088463|NCT02248350|Behavioral|Stretching Control Group|Participants randomized into the control group will be provided an informational booklet with stretching techniques and exercises and will be asked to stretch at least 20-minutes a day for the duration of the study.
16088464|NCT02248337|Drug|Colon preparation for colonoscopy|Colon cleansing prior to perform colonoscopy
16088465|NCT02248298|Drug|2h-AFL-PDT|AFL therapy was performed using a 2940-nm Er:YAG AFL (Joule; Sciton Inc., Palo Alto, CA, USA) at 300-550µm ablation depth, level 1 coagulation, 22% treatment density, and a single pulse. In the 3h-MAL-PDT group, the above mentioned procedures were not performed. Immediately after AFL treatment, an approximately 1-mm thick layer of MAL (Metvix, PhotoCure ASA, Oslo, Norway) was applied to the lesion and on 5 mm of surrounding normal tissue. The area was covered with an occlusive dressing (Tegaderm, 3M, St. Paul, MN, USA). After incubation for 2 hours, the dressing and cream were removed, and the area was cleansed with saline. The area was irradiated with a red light-emitting diode lamp (Aktilite CL 128; PhotoCure ASA, Oslo, Norway) with peak emission at 632 nm, placed 5 cm away from the skin surface and total light dose of 37 J/cm-2
16088466|NCT02248298|Drug|3h-AFL-PDT|AFL therapy was performed using a 2940-nm Er:YAG AFL (Joule; Sciton Inc., Palo Alto, CA, USA) at 300-550µm ablation depth, level 1 coagulation, 22% treatment density, and a single pulse. In the 3h-MAL-PDT group, the above mentioned procedures were not performed. Immediately after AFL treatment, an approximately 1-mm thick layer of MAL (Metvix, PhotoCure ASA, Oslo, Norway) was applied to the lesion and on 5 mm of surrounding normal tissue. The area was covered with an occlusive dressing (Tegaderm, 3M, St. Paul, MN, USA). After incubation for 3 hours, the dressing and cream were removed, and the area was cleansed with saline. The area was irradiated with a red light-emitting diode lamp (Aktilite CL 128; PhotoCure ASA, Oslo, Norway) with peak emission at 632 nm, placed 5 cm away from the skin surface and total light dose of 37 J/cm-2
16088467|NCT02248298|Drug|3hr-MAL-PDT|an approximately 1-mm thick layer of MAL (Metvix, PhotoCure ASA, Oslo, Norway) was applied to the lesion and on 5 mm of surrounding normal tissue. The area was covered with an occlusive dressing (Tegaderm, 3M, St. Paul, MN, USA). After incubation for 3 hours, the dressing and cream were removed, and the area was cleansed with saline. The area was irradiated with a red light-emitting diode lamp (Aktilite CL 128; PhotoCure ASA, Oslo, Norway) with peak emission at 632 nm, placed 5 cm away from the skin surface and total light dose of 37 J/cm-2.
16088468|NCT02248285|Device|FilmArray™ Gastrointestinal (GI) Panel|BioFire Diagnostics, LLC (BioFire) has developed a polymerase chain reaction (PCR), high-resolution melting analysis instrument called the FilmArray™ and an associated reagent pouch that together are capable of simultaneously detecting multiple microorganisms in a single sample. The FilmArray™ Gastrointestinal (GI) Panel pouch contains freeze-dried reagents to perform nucleic acid purification and nested, multiplex PCR for the identification of common bacterial, viral, and parasite microorganisms responsible for infectious gastroenteritis. The test was made available for sale in the US and EU following FDA clearance and CE marking in May, 2014
16088469|NCT02248272|Other|Isocaloric diet with 3 meals|Isocaloric diet with 3 meals in order to maintain volunteers' weight, tailored to individual energy needs, with the same macronutrient composition. The volunteers were free to choose the foods they used to consume before. However, in order to assist them to adapt to the different meal frequency, individualized instructions were given to all volunteers before their entry to the study. An example of a 7-day diet menu was prescribed for both diet programs and analytical food exchange lists of different food groups were also provided.
16088470|NCT02248272|Other|Isocaloric diet with 6 meals|Isocaloric diet with 6 meals in order to maintain volunteers' weight, tailored to individual energy needs, with the same macronutrient composition. The volunteers were free to choose the foods they used to consume before. However, in order to assist them to adapt to the different meal frequency, individualized instructions were given to all volunteers before their entry to the study. An example of a 7-day diet menu was prescribed for both diet programs and analytical food exchange lists of different food groups were also provided.
16088471|NCT02248259|Drug|BI 409306|Oral single dose of BI 409306
16088472|NCT02248259|Drug|Itraconazole|Oral dose, twice daily on Day -3, once daily on Day -2 to Day 2 of Itraconazole
16088473|NCT02248259|Drug|BI 409306|Oral single dose
16088474|NCT02248246|Device|Harmonic ACE®+7 Shears|"Vessel sealing performance assessed for transection and sealing of the following named vessels:
~Inferior mesenteric artery (IMA)
~Inferior mesenteric vein (IMV) (if identified)"
16088475|NCT02248233|Drug|Nimodipine|Jiangsu Jichuan Pharmaceutical Co., Ltd., Jiangsu Province, China
16088476|NCT02248233|Drug|Saline + citicoline|physiological saline + citicoline 2.0 g, once a day, via intravenous drip, for 10 consecutive days.
16088477|NCT02248220|Drug|Pramipexole|
16088478|NCT02248207|Drug|Pramipexole|
16088479|NCT02248194|Device|Tactile electrosurgical ablation probe|
16088480|NCT02248194|Device|Hysteroscopic endometrial ablation|
16088481|NCT02248181|Drug|Pramipexole|
16088482|NCT02248168|Drug|Pramipexole|
16088483|NCT02248155|Drug|Pramipexole|
16088484|NCT02248142|Drug|Pramipexole|
16088485|NCT02248129|Drug|Telmisartan and hydrochlorothiazide|
16088486|NCT02248116|Drug|Talsaclidine|
16088487|NCT02248103|Procedure|Periosteal pedicle graft|Autogenous pedicle graft harvested from the periosteum
16088488|NCT02248103|Biological|Bioresorbable collagen membrane|Biocollagen is a thin equine Achilles tendon collagen barrier membrane used for guided tissue regeneration
16088490|NCT02248090|Drug|AZD9496|If initial dosing of AZD9496 is tolerated then subsequent cohorts will test increasing doses until a maximum tolerated dose or maximum feasible dose is defined
16088491|NCT02248077|Device|AutoloGel|
16088492|NCT02248077|Other|Usual and Customary Care (UCC)|
16088493|NCT02248064|Device|Auto-titrating oxygen system|The auto-titrating oxygen system contains a number of components working together to produce variable oxygen flow. An oximeter measures the oxygen saturation of a patient and via Bluetooth this is relayed to a control centre in a mobile phone. This in turn regulates a flow meter which adjust oxygen flow.
16088494|NCT02248051|Drug|CXA-10|CXA-10 Injectable Emulsion is a sterile emulsion containing CXA-10 in a formulation containing soybean oil, medium chain triglycerides oil, egg phospholipids, sucrose, and disodium EDTA. CXA-10 Injectable Emulsion will be administered intravenously. The active emulsion will be diluted in a vehicle emulsion.
16088495|NCT02248038|Procedure|open surgery|Patients in this arm undergo radical resection of colon cancer in open surgery.Open surgery is a conventional technique for colorectal cancer patients.
16088496|NCT02248038|Procedure|laparoscopic surgery|Patients in this arm undergo radical resection of colon cancer in laparoscopic surgery.Laparoscopic surgery is a new and minimum invasive technique for colorectal cancer patients.
16088497|NCT02248025|Other|Observational study: No special intervention will be made.|No special intervention will be made, only data will be collected before, and after a passive leg raising and a fluid challenge decided and performed by the attending physician.
16088498|NCT02248012|Drug|Everolimus , temozolomide|
16088499|NCT02247986|Drug|Methylphenidate Hydrochloride|Bold signal changes by methylphenidate on DBD
16088500|NCT02247973|Biological|mesenchymal stem cells|Intravenous administration of up to 1~2x10^6 MSCs per kg,for 2 times,d0 and d14
16088501|NCT02247973|Biological|mesenchymal stem cells|bone marrow derived mesenchymal stem cells from related donors.
16088502|NCT02247960|Drug|Ciprofloxacin|
16088503|NCT02247921|Other|Rehabilitation|Patients recruited into the intervention arm will have their family-nominated caregivers trained by a trained nurse and guided by a culturally appropriate and easy-to-understand rehabilitation manual to be given to caregivers at the last session, shortly before hospital discharge to reduce contamination. The training sessions will take at least 90 minutes per day for 2 or 3 days.The nurse will call the patients and caregivers at 2, 4, and 8 weeks after hospital discharge to monitor progress and offer guidance on rehabilitation.Duration of the standardized yet individualized intervention by nurses will be 8 weeks; however, trained caregivers are expected to deliver the rehabilitation services to patients as long as they are needed.
16088504|NCT02247908|Other|Surgeon General's Warning|"Participants will be randomly assigned to receive warnings with one of the four Surgeon General's Warnings on their cigarette packs for 4 weeks:
~SURGEON GENERAL'S WARNING: Smoking Causes Lung Cancer, Heart Disease, Emphysema, and May Complicate Pregnancy.
~SURGEON GENERAL'S WARNING: Quitting Smoking Now Greatly Reduces Serious Risks to Your Health.
~SURGEON GENERAL'S WARNING: Smoking by Pregnant Women May Result in Fetal Injury, Premature Birth, and Low Birth Weight.
~SURGEON GENERAL'S WARNING: Cigarette Smoke Contains Carbon Monoxide."
16088505|NCT02247908|Other|Graphic Warning|"Participants will be randomly assigned to receive one of the following four graphic warnings on their cigarette packs for 4 weeks:
~Text: WARNING: Cigarettes are addictive. Image: Man smoking through tracheotomy hole.
~Text: WARNING: Cigarettes causes fatal lung disease. Image: Healthy lungs next to diseased lungs.
~Text: WARNING: Cigarettes cause cancer. Image: Mouth with cancerous lesion on lip.
~Text: WARNING: Smoking can kill you. Image: Woman dying from cancer."
16088506|NCT02247895|Device|Sham Treatment|Subjects will undergo the same protocol as the treatment group except no electrical stimulation will be applied.
16088507|NCT02247895|Device|Electrical stimulation|Two thirty minute sessions of neuromuscular electrical stimulation applied to both quadriceps for seven days for a total of 14 treatments
16088508|NCT02247882|Other|Patient Education|"The educational program will comprise a multidisciplinary team: doctor, pharmacist, nurse, nutritionist, psychologist, physiotherapist and physical educator. Classes will be weekly in groups for eight weeks, with a duration of two hours.
~The education program will include the following items: guidelines about the disease and its complications, strategies for pain management (pharmacological and cognitive), physical exercise, nutrition and weight control, medication (type, interactions, current trends, side effects ), balance, proprioception, fall prevention, coping with chronic pain."
16088509|NCT02247882|Other|Aquatic Physical Therapy|The exercise protocol will consist of: five minutes of heating with walking and patellar mobilization; ten minutes stretching the muscles of the lower limbs (quadriceps, gluteus, adductors and abductors of hip sural triceps and hamstrings); ten minutes isometric and dynamic exercises with elastic (quadriceps, gluteus, adductors and abductors of hip sural triceps and hamstrings); twenty minutes away from aerobic exercise (stationary running deep running water); ten minutes in functional training step and proprioceptive exercises; and five minutes of cooling with stretching of muscles of lower limbs (quadriceps, gluteus, adductors and abductors of hip sural triceps and hamstrings).
16088510|NCT02247869|Drug|dose dense ABVD|"dose dense ABVD will be administered intravenously on day 1 and 8 every 21 days Chemotherapy regimen
~Doxorubicin 25 mg/m2 i.v. day 1 and 8
~Bleomycin 10 mg/m2 i.v. day 1 and 8
~Vinblastine 6 mg/m2 i.v. day 1 and 8
~Dacarbazine 375 mg/m2 i.v. day 1 and 8
~Granulocyte colony-stimulating factor (G-CSF): days 9 to 14"
16088511|NCT02247856|Other|Noninvasive ventilation|Bilevel positive pressure (BiPAP Synchrony, Respironics®, Murrysville, Pennsylvania, USA) was applied through face mask (Comfort Full 2, Respironics®, Murrysville, Pennsylvania, USA) attached with straps and pressure adjusted were 12 cmH2O of inspiratory pressure and 5 cmH2O of expiratory pressure after a period of adaptation before beginning the procedure to avoid ventilator-patient asynchrony
16088512|NCT02247856|Device|Jet Nebulizer|"Both nebulizers were charged with 2.5 mg of salbutamol and 0.25 mg of ipratropium bromide and 3 mL of saline solution was added to complete 3 Ml. JN (Mist yMax, Air Life, Yorba Linda, USA) was positioned in the circuit using a T piece, particle size generation in a 5 µm range (according to the manufacturer information) and flow oxygen tritated at 8 L/min"
16088513|NCT02247856|Device|Vibrating Mesh Nebulizer (VMN)|Both nebulizers were charged with 2.5 mg of salbutamol and 0.25 mg of ipratropium bromide and 3 mL of saline solution was added to complete 3 Ml. VMN (Aeroneb Solo, Galway, Ireland) was positioned in the mask using an elbow (Elbow Kit, Respironics®, Murrysville, Pennsylvania, USA), particle size generation in a 1 µm and connected to electrical energy.
16088514|NCT02247843|Biological|βAS3-FB vector transduced peripheral blood CD34+ cells|CD34+ from the peripheral blood of patients with sickle cell disease (SCD) are transduced ex-vivo with the Lenti/βAS3-FB lentiviral vector. The transduced cells are then infused into the patient.
16088515|NCT02247830|Other|Chamomilla recutita gel|Such intervention will be characterized by topical application of C. recutita gel, concomitantly to the initiation of radiotherapy, should be applied on the irradiated region three times daily throughout the period of realization of radiotherapy sessions area, and nursing consultations with equipment instructional (usual care).
16088516|NCT02247830|Drug|Urea cream|Experimental Group 02: usual care + Topical Application of Urea cream. The intervention will be characterized by topical application of urea-based cream on the irradiated region three times daily throughout the period of realization of radiotherapy sessions, in addition to nursing consultation with instructional material (usual care).
16088517|NCT02247817|Device|Hybrid CRT-D/P implantation|
16088518|NCT02247804|Drug|Bimatoprost SR|Bimatoprost SR administered in the study eye on Day 1, Week 16, and Week 32.
16088519|NCT02247804|Drug|Active Comparator: Timolol 0.5%|Timolol 0.5% administered once in the morning and once in the evening for up to 20 months.
16088520|NCT02247804|Other|Sham: Applicator Without Needle|Sham administered on Day 1, Week 16, and Week 32.
16088521|NCT02247804|Drug|Timolol Vehicle (placebo)|Timolol vehicle administered once in the morning and once in the evening for up to 20 months.
16088522|NCT02247791|Procedure|Uncemented femoral stem|All patients will be randomized to operation with either an uncemented femoral stem or a cemented femoral stem
16088523|NCT02247791|Procedure|Cemented femoral stem|All patients will be randomized to operation with either an uncemented femoral stem or a cemented femoral stem
16088524|NCT02247778|Procedure|conventional plate osteosynthesis|Standard incision
16088525|NCT02247778|Procedure|mini-incision-type osteosynthesis|Mini-incision
16088526|NCT02247765|Device|Arterial line|Arterial line is inserted to draw a CO-Oximeter value as it is the gold standard and as advised in ISO 80601
16088527|NCT02247765|Device|Motion|The subject is asked to move their hand by either rubbing or tapping their fingers at a specified frequency and amplitude during portions of the hypoxic procedure.
16088528|NCT02247752|Other|inactive carrier|"Yearly demographic, clinic, biologic and ultrasonic data collection realized during usual follow-up as recommended.
~Yearly centralisation of a complementary biological analysis in Paul Brousse Hospital laboratory of virology."
16088529|NCT02247739|Biological|Recombinant human C1 inhibitor|
16088530|NCT02247739|Other|Placebo|
16088531|NCT02247726|Drug|Saline Placebo (0.5mL injection)|
16088532|NCT02247726|Drug|RSV F vaccine (0.5mL injection)|
16088533|NCT02247687|Drug|Protease inhibitor|"Modification in the antiretroviral treatment
~•Switch arm for protease inhibitor : intervention switch of current boosted protease inhibitor for Prezista® (darunavir)/ Norvir® (ritonavir) (switch for a drug with a higher genetic barrier) 600/100 mg two times a day (BID) with counseling."
16088534|NCT02247687|Drug|Isentress® (raltegravir)|• Addition of Isentress® (raltegravir) arm :Isentress® (raltegravir) 400 mg two times a day (BID) added to current antiretroviral treatment with counseling
16088535|NCT02247687|Other|Counseling arm|No change of antiretroviral treatment but only counseling
16088536|NCT02247674|Procedure|Bilateral movement training|Exercise training of bilateral isometric handgrip force training group consisted of 60 minutes of bilateral isometric handgrip force training 3 days per week for 4 weeks (total 12 sessions)
16088537|NCT02247648|Drug|tramadol|Patients from tramadol group received tramadol 100 mg day one, 100 mg day 2, and 200 mg day 3
16088538|NCT02247648|Drug|Placebo|"Patients from control group received a shame tramadol pill on day one, two, and 3"
16088539|NCT02247635|Behavioral|Healthy lifestyle and adherence|"Behavioral intervention to improve adherence to treatment and 1) Maintain a caloric restriction of 500kcal in overweight adults, 2) Have a total fat intake <30% (including cholesterol and trans fat), 3) A total intake of complex carbohydrates for 50%, 3) 30g fiber, 4) Perform at least 30 minutes of moderate physical activity at least 5 days a week; 5) Maintain education and behavioral therapy changes in your lifestyle.
~The model consists of monthly visits to the doctor, nutritionist and psychologist, for screening cardiometabolic risk factors, to know limitations on treatment adherence, to start intervention to evaluate reasons for success or failure, to evaluate and maintain motivation to adherence to diet, physical activity and medication and long-term care"
16088540|NCT02247609|Genetic|Anti-CD19 CAR T cells|Autologous 4th generation withdrawable lentiviral-transduced anti-CD19-CAR T cells
16088541|NCT02247596|Drug|Resveratrol|1g tds 2 weeks
16088542|NCT02247596|Drug|Placebo|Sugar pill 1g tds for 2 weeks
16088543|NCT02247570|Procedure|Vestibular Rehabilitation|Stimulation of the vestibular system by off axis rotational therapy, gaze stabilization, eye movement strategies, balance training
16088544|NCT02247557|Drug|Liposome encapsulated BoNT-A|Liposome encapsulated BoNT-A ( mixed BOTOX 200U/10ml in Liposome 80mg/40ml) in single intravesical instillation
16088545|NCT02247557|Drug|BOTOX 200U in normal saline|BOTOX 200U in normal saline (BoNT-A/NS) 50ml in single intravesical instillation
16088546|NCT02247557|Drug|Normal saline|Normal saline (N/S) 50ml in single intravesical instillation
16088547|NCT02247544|Drug|Trabectedin|Trabectedin administered at a dose of 1.5 mg/m2 - 1.3 mg/m2 (at investigator's discretion, with a top-dose of 2.6 total mg per cycle) as a 24-hour continuous infusion via a central venous access until progressive disease, major toxicity, patient's intolerance, unwillingness to continue treatment, or medical decision by the responsible physician
16088548|NCT02247531|Drug|Lampalizumab|10 mg dose of lampalizumab administered intravitreally.
16088549|NCT02247531|Other|Sham Comparator|A sham injection is a procedure that mimics an intravitreal injection of lampalizumab.
16088550|NCT02247518|Drug|Cialis Tab. 5mg|
16088551|NCT02247518|Drug|Harnal-D Cap. 0.2mg|
16088552|NCT02247505|Drug|Harnal-D Cap. 0.2mg|
16088553|NCT02247505|Drug|Cialis Tab. 5mg|
16088554|NCT02247479|Drug|Lampalizumab|Participants will receive 10 mg dose of lampalizumab administered intravitreally.
16088555|NCT02247479|Other|Sham|A sham injection is a procedure that mimics an intravitreal injection of lampalizumab.
16088556|NCT02247466|Drug|Rocuronium and Sugammadex|
16088868|NCT02245256|Drug|placebo control|placebo
16088557|NCT02247453|Other|screening|"All subjects undergo baseline LDCT examination, spirometry and miRNA profiling. Individuals with negative miRNA profile repeat the plasma assay at 3 years. Individuals with low-risk miRNA profile repeat the plasma assay and LDCT at 2 years, without additional diagnostic examinations if not required by the screening protocol.
~Individuals with high-risk miRNA profile undergo additional diagnostic examinations consisting in PET in case of concurrent suspicious or positive CT, or WB MRI +- needle aspiration biopsy in case of negative CT."
16088558|NCT02247440|Drug|Peg-interferon + ribavirin under HIV physician supervision|Peg-interferon + ribavirin under HIV physician supervision
16088559|NCT02247427|Device|Cardiac Resynchronization Therapy Device|Cardiac Resynchronization Therapy Device pacing activity, on or off
16088560|NCT02247414|Drug|Warfarin|From postoperative day 3, patients will receive oral Warfarin 2.5mg qd with titration of dose to maintain a target INR of 2-3 for 1 year.
16088561|NCT02247414|Drug|Dipyridamole|From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months.
16088562|NCT02247414|Drug|Aspirin|From postoperative day 3, patients will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for 1 year.
16088563|NCT02247414|Drug|Low Molecular Weight Heparin|From postoperative day 3, patients will receive subcutaneous injection of Low Molecular Weight Heparin (4100 IU) once daily for first five days.
16088564|NCT02247401|Drug|2 DAA|ABT-450/r/ABT-267 tablets
16088565|NCT02247401|Drug|RBV|Ribavirin tablets
16088566|NCT02247388|Behavioral|Computerized Alcohol Screening|iPad based automated alcohol screening
16088567|NCT02247388|Behavioral|Brief Negotiated Interview|iPad based automated brief negotiated interview (BNI)
16088568|NCT02247375|Drug|Low dose of BIIL 284 BS tablets|
16088569|NCT02247375|Drug|High dose of BIIL 284 BS tablets|
16088570|NCT02247375|Drug|Placebo|
16088571|NCT02247362|Biological|VAX2012Q|Recombinant influenza HA vaccine consisting of two Influenza A subtypes and two Influenza B lineages and delivered IM
16088572|NCT02247362|Other|Placebo|Vaccine Diluent
16088573|NCT02247349|Biological|BMS-986012 (anti-fucosyl-GM1)|
16088574|NCT02247349|Biological|Nivolumab|
16088575|NCT02247336|Behavioral|Family health history platform (MeTree)|Participants will enter their family health history information into a family health history platform, patients and providers will receive a decision support document and pedigree
16088576|NCT02247323|Other|Risk of malignancy index|Calculation of RMI before sugery.
16088577|NCT02247310|Drug|Interferon beta-1b (Betaferon®, BAY 86-5046)|Patients will be treated with Betaferon
16088578|NCT02247310|Device|BETACONNECT|Auto-injector device to support the injection of Betaferon
16088579|NCT02247297|Procedure|Blood collection|Diagnostic blood collection
16088580|NCT02247284|Device|RNFL and BMO-MRW SD-OCT|Masurement of peripapillary RNFL measurements with Heidelberg Spectralis SD-OCT (Heidelberg Engeneering GmbH, Heidelberg, Germany) old protocoll and in addition with the new Glaucoma Premium Module (software version 6.0) tocoll, which in addition to RNFL measurements include measurement of Bruch's Membrane Opening-based minimum rim width (BMO-MRW).
16088581|NCT02247271|Behavioral|Diabetes health coach support|Receives support from a trained peer health coach for a six month period
16088582|NCT02247258|Drug|Azathioprine|See arm/group descriptions
16088583|NCT02247258|Drug|Azathioprine in case of endoscopic recurrence|See arm/group descriptions
16088584|NCT02247258|Procedure|Ileocolonoscopy|See arm/group descriptions
16088585|NCT02247258|Procedure|Small bowel follow trough|See arm/group descriptions
16088586|NCT02247245|Drug|Ivabradine|Ivabradine 7.5mg
16088587|NCT02247245|Other|Atrial fibrillation|Pacemaker base rate alteration
16088588|NCT02247245|Drug|Placebo|Placebo
16088589|NCT02247232|Drug|Z-100|
16088590|NCT02247232|Drug|Placebo|
16088591|NCT02247219|Behavioral|Counselling and education individually and in groups|The counselling method is based om Motivational Interviewing
16088592|NCT02247206|Behavioral|Behavior Therapy for Tics (CBIT)|CBIT is an 8-session 10-week behavioral treatment for chronic tic disorders, including Tourette Syndrome. The first two sessions are 90 minutes, with subsequent sessions lasting 60 minutes. The treatment consists of Habit Reversal Training (awareness training, competing response training, and social support), and function-based assessment to reduce the impact of environmental or other stimuli on tic severity. The treatment also consists of relaxation techniques to reduce tic-related stress and tension, and behavioral rewards to motivate treatment compliance.
16088593|NCT02247193|Drug|Botulinum Toxin Type A|Injection of toxin at the time of surgery at cleft lip repair site
16088594|NCT02247193|Drug|Normal Saline Injection|Injection of normal saline into cleft lip at time of surgical repair.
16088595|NCT02247180|Behavioral|cognitive rehabilitation|
16088596|NCT02247180|Behavioral|standardized cognitive training|
16088597|NCT02247167|Procedure|adenotonsillectomy|adenotonsillectomy in children with OSAS and adenotonsillar hypertrophy.
16088598|NCT02247154|Biological|Vigam® (Human Normal Immunoglobulin)|
16088599|NCT02247141|Biological|Subgam® (Human Normal Immunoglobulin Solution)|
16088600|NCT02247128|Drug|Aspirin + clopidogrel|
16088601|NCT02247128|Drug|Aspirin monotherapy|
16088602|NCT02247128|Drug|OAC + clopicogrel|
16088603|NCT02247128|Drug|OAC monotherapy|
16088604|NCT02247102|Dietary Supplement|Isomaltulose|"Each subject receives isomaltulose on Study Day 1. After having completed the wash-out period, each subject receives sucrose on Study Day 2.
~Dosage of 1 g/ kg body weight (rounded up to the nearest 0.5 kg)."
16088605|NCT02247102|Dietary Supplement|Sucrose|"Each subject receives sucrose on Study Day 1. After having completed the wash-out period, each subject receives isomaltulose on Study Day 2.
~Dosage of 1 g/ kg body weight (rounded up to the nearest 0.5 kg)."
16088606|NCT02247089|Other|Massage Therapy|Intervention consists of administering a 30-minute-long upper body massage by a registered massage therapist following a massage protocol developed by Vancouver College of Massage Therapy (VCMT).
16088607|NCT02247089|Other|Journal reading (No massage therapy)|Intervention consists of journal reading in the same sitting position as the massage therapy session for approximately 30 minutes.
16088608|NCT02247076|Behavioral|Grazing|
16088609|NCT02247076|Behavioral|Time-restricted feeding (early eating)|
16088610|NCT02247063|Device|High-Definition Transcranial Direct Current Stimulation (HD-tDCS)|HD-tDCS is a non-invasive brain neuromodulatory method for M1 that involves sending a weak electrical current into your brain.
16088611|NCT02247050|Behavioral|Commitment invitation|Clinicians will be invited to commit to follow 3 Choosing Wisely recommendations. Those that choose to commit will also receive point-of-care commitment reminders, point-of-care Choosing Wisely patient education handouts, and weekly emails with decision support resources.
16088612|NCT02247037|Other|Chemotherapy|Patients are treated with neoadjuvant chemotherapy as according to the standard of care guidelines. Patients with metastatic disease are treated according to standard of care guidelines.
16088613|NCT02247011|Other|Questionaire survey|We used a questionnaireto collect clinical data of the subjects. The questionnaire includes basic data, menstruation and pregnancy, habits and customs, daily activity, common healthy situation, history of drugs and history of factures.
16088614|NCT02247011|Radiation|Bone mineral density examination|We use dual energy X-ray absorptiometry (DXA) to exam the BMD at lumbar spine (L2-4, LS) and hip.
16088615|NCT02247011|Radiation|Vertebral fracture assessment|X-ray of thoracic and lumbar spine was taken, and the pictures were read by radiological specialists. The diagnosis of vertebral fracture was executed according to Genant's semiquantitative technique.
16088616|NCT02247011|Other|Biochemical markers analysis|Fasting blood sample was collected for each subject. Common biochemical maerkers including serum calcium(Ca), serum phosphate(P), serum glucose(Glu), serum creatinine(Cr), alkaline phosphatase(ALP), alanine aminotransferase(ALT) were analyzed. Besides, we also detect bone speficific markers including 25-hydroxyl Vitamin D(25OHD), parathyroid hormone(PTH), β-isomerized C-terminal telopeptide of type I collagen(β-CTX), N-terminal procollagen of type 1 collagen(P1NP) and osteocalcin(OC).
16088617|NCT02246998|Drug|STB|150/150/200/300 mg fixed dose combination (FDC) tablet administered orally once daily with food
16088618|NCT02246998|Drug|TVD|200/300 mg FDC tablet administered orally once daily with food
16088619|NCT02246998|Drug|ATR|600/200/300 mg FDC tablet administered orally once daily on an empty stomach at bedtime
16088620|NCT02246998|Drug|RTV|100 mg tablet administered orally once daily with food
16088621|NCT02246998|Drug|ATV|300 mg capsule administered orally once daily with food
16088622|NCT02246998|Drug|ABC/3TC|600/300 mg FDC tablet administered orally once daily with food
16088623|NCT02246998|Drug|Iohexol|1500 mg solution administered intravenously at baseline, and at Weeks 4, 8, 16, and 24
16088624|NCT02246985|Dietary Supplement|Control|The bread and mayonnaise in this meal does not have vegetable powders incorporated into them. Hence this meal does not contain carotenoids.
16088625|NCT02246985|Dietary Supplement|Vegetable bread only|A vegetable powder (carrot and tomato) containing bread portion will be served alone. The amount of vegetable powder in the bread portion will be standardised to contain a known amount of carotenoids.
16088626|NCT02246985|Dietary Supplement|Plain bread with vegetable mayonnaise|Plain bread will be served with a vegetable powder (carrot and tomato) containing mayonnaise. The amount of vegetable powder in the mayonnaise will be standardised to contain a known amount of carotenoids.
16088627|NCT02246985|Dietary Supplement|Vegetable bread with plain mayonnaise|A vegetable powder (Carrot and tomato) containing bread portion will be served with plain mayonnaise. The amount of vegetable powder in the bread portion will be standardised to contain a known amount of carotenoids
16088628|NCT02246972|Behavioral|Virtual Reality Exposure Therapy (VRET)|6 to 12 90-minute individual treatment sessions. During VRET sessions patients will wear a head-mounted display with stereo earphones that will provide visual and audio cues consistent with Iraqi or Afghan military scenarios or other base-related scenarios as appropriate for the individual patient.
16088629|NCT02246959|Behavioral|Process Incentive|Daily sweepstake conditional on daily medication adherence
16088630|NCT02246959|Behavioral|Outcome Incentive|Incentives conditional on LDL cholesterol reduction
16088631|NCT02246946|Device|Positive Airway Pressure|To this group, Intermittent Positive Airway Pressure Breathing with 15 mmHg by Muller Reanimatior (Engemed, Brazil) device with a rubber facial mask will be provide
16088632|NCT02246946|Other|Conventional Chest Physiotherapy|To this group, routine physiotherapy exercises will be conducted plus Intermittent Positive Airway Pressure Breathing with 4 mmHg by Muller Reanimatior (Engemed, Brazil) device with a rubber facial mask will be provide
16088633|NCT02246946|Procedure|Control group|to this group, Airway Pressure Breathing with 4 mmHg by Muller Reanimatior (Engemed, Brazil) device with a rubber facial mask will be provide
16088634|NCT02246933|Other|PUFA Diet|The 7-day diet will consist of 50% carbohydrate, 15% protein, and 35% fat. 21% of total energy will be poly-unsaturated fatty acids, 9% mono-unsaturated fatty acids, and 5% saturated fatty acids.
16088635|NCT02246933|Other|Control Diet|The 7-day diet will consist of 50% carbohydrate, 35% fat, and 15% protein. Furthermore, 7% of total energy will be poly-unsaturated fatty acids, 15% of total energy will be mono-unsaturated fatty acids, and 13% of total energy will be saturated fatty acids.
16088636|NCT02246920|Drug|Fluticasone propionate|50 mcg/actuation Nasal Spray
16088637|NCT02246920|Drug|Flonase®|50 mcg/actuation Nasal Spray
16088638|NCT02246920|Drug|Placebo|Inactive Nasal Spray
16088639|NCT02246907|Other|Exercise|All intervention patients will participate in an individualized prescriptive exercise intervention 2 to 4 times per week for a period of the induction chemotherapy/in-hospital recovery. The exercise intervention will begin on week 1 of the study, the day after the first batteries of initial assessments are concluded. Each exercise session will be divided into two parts. One part will be administered in the morning and the second one late in the afternoon. There will be a period of rest of at least 36 hours between each exercise session.
16088640|NCT02246894|Biological|Optivate® (Human Coagulation Factor VIII)|
16088641|NCT02246881|Biological|Optivate® (Human Coagulation Factor VIII)|
16088642|NCT02246868|Biological|Optivate® (Human Coagulation Factor VIII)|
16088643|NCT02246855|Biological|Gammaplex® (Human Normal Immunoglobulin)|
16088644|NCT02246842|Biological|D-Gam® (human anti-D immunoglobulin)|
16088645|NCT02246842|Biological|Rhophylac® (human anti-D immunoglobulin)|
16088646|NCT02246829|Procedure|Intravitreal injection|2 mg intravitreal Aflibercept initiated with one injection every 4 weeks for three consecutive doses (loading dose) The duration of the follow-up is 12 weeks. This means 3 injections per patient should be given over the study period
16088647|NCT02246816|Drug|0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized)|0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized)
16088648|NCT02246803|Procedure|CABG+Pulmonary vein isolation procedure|Coronary artery bypass (CABG) using cardio-pulmonary bypass (CBP) and occlusion. Concomitant pulmonary vein isolation in CBP prior to occlusion and CABG
16088649|NCT02246803|Procedure|Isolated CABG|Coronary artery bypass (CABG) using cardio-pulmonary bypass (CBP) and occlusion.
16088650|NCT02246790|Procedure|Biatrial radiofrequency ablation and CABG|Coronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant biatrial RFA during CPB.
16088651|NCT02246790|Procedure|Left atrial radiofrequency ablation and CABG|Coronary artery bypass (CABG) using cardio-pulmonary bypass (CPB) and occlusion. Concomitant left atrial RFA during CPB.
16088652|NCT02246777|Device|Ex-PRESS® Glaucoma Filtration Device, Model P50PL|
16088653|NCT02246764|Drug|AR-13324 Ophthalmic Solution 0.02%|1 drop once daily (QD), PM, OU
16088654|NCT02246764|Drug|AR-13324 Ophthalmic Solution 0.02% BID|1 drop BID, AM/PM, OU
16088655|NCT02246764|Drug|Timolol maleate Ophthalmic Solution 0.5% BID|1 drop BID, AM/PM, OU
16088656|NCT02246764|Other|Placebo|1 drop QD, AM, OU
16088657|NCT02246751|Device|Targeted Training for trunk control|Orthotics Research and Locomotor Research Unit (ORLAU) standers will be custom fit to help the child train at the segmental level of the trunk where they begin to lose control of posture. The typical course of treatment involves loaning the customized equipment to each family for use in their home or in their child's educational setting. Training occurs once daily usually for 30-45 minutes. This is done 5 or 6 days per week. Training programs typically involve playing with balls or balloons or video games that motivate the child to hold the head erect and to wave the arms and hands and move the upper body. The researchers evaluate children every 8 weeks and adjust the stander to lower levels of support as the child gains control.
16088658|NCT02246738|Other|Blood Collection|
16088659|NCT02246725|Other|Contact with palliative care unit.|
16088660|NCT02246712|Drug|Single oral dose of 100 mg racemic tramadol|Serial blood samples were collected up to 24 h after drug administration; Pain was evaluated at the same time of blood sampling using visual analog scale
16088661|NCT02246712|Other|CYP2D6 phenotype|"Patients were phenotyped using metoprolol (100 mg, single oral dose). Urine was collected up to 8 hours after metoprolol administration. Urinary concentrations of metoprolol and alfa-hydroxymetoprolol were determined by high performance liquid chromatography (HPLC), using fluorescence detector.
~CYP2D6 phenotyped was determined by alfa-hydroxymetoprolol/metoprolol urinary rato"
16088662|NCT02246712|Other|CYP3A phenotype|"A single oral dose of midazolam (15 mg) was administered to all patients. Serial blood samples were collected up to 6 hours after the administration of midazolam.
~The concentration of midazolam was determined in plasma in order to calculate midazolam clearance.
~The in vivo activity of CYP3A was evaluated by midazolam oral clearance."
16088663|NCT02246712|Genetic|CYP2B6 genotype|The single nucleotide polymorphism 516G>T in CYP2B6 gene was evaluated using polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP).
16088664|NCT02246699|Device|KiOnutrime®-Cs|The product will be taken orally within 15 minutes before main meals (breakfast, lunch and dinner) with a large glass of water. Subjects will have to take 2 capsules of 500mg, 3 times per day.
16088665|NCT02246699|Other|Placebo|The product will be taken orally within 15 minutes before main meals (breakfast, lunch and dinner) with a large glass of water. Subjects will have to take 2 capsules, 3 times per day.
16088666|NCT02246686|Drug|STW5-II (Iberogast N, BAY98-7410)|Application over 12 weeks 20 drops three time daily
16088667|NCT02246686|Drug|Placebo|Application over 12 weeks 20 drops three time daily
16088668|NCT02246673|Drug|RDEA3170 15 mg|
16088669|NCT02246673|Drug|RDEA3170 10 mg|
16088670|NCT02246673|Drug|RDEA3170 2.5|
16088671|NCT02246673|Drug|RDEA3170 5 mg|
16088672|NCT02246673|Drug|Febuxostat 40 mg|
16088673|NCT02246673|Drug|Febuxostat 80 mg|
16088674|NCT02246660|Drug|Resveratrol|"The dose of Resveratrol will be 500 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative.
~OR
~The dose of Resveratrol will be 125 mg daily for six months. Resveratrol is taken orally. Resveratrol is a natural plant derivative."
16088675|NCT02246660|Drug|Placebo|Placebo will be taken orally for 6 months.
16088676|NCT02246647|Diagnostic Test|Permeability measurement|Saccharide excretion was compared between IBS-C and healthy volunteers
16088677|NCT02246647|Procedure|Esophagogastroduodenoscopy|Duodenal biopsies were collected from IBS-C and healthy volunteers
16088678|NCT02246647|Procedure|Flexible sigmoidoscopy|Colonic biopsies were collected from IBS-C and healthy volunteers
16088679|NCT02246634|Other|Diffusion Weighted MRI scan|Non-contrast diffusion weighted MRI scan of the liver
16088680|NCT02246621|Drug|Abemaciclib|Administered orally
16088681|NCT02246621|Drug|Anastrozole|Administered orally
16088682|NCT02246621|Drug|Letrozole|Administered orally
16088683|NCT02246621|Drug|Placebo|Administered orally
16088684|NCT02246608|Device|NPWT Standard of Care plus Oasis wound product|Oasis® is a porcine acellular small intestine submucosa material compatible with human tissue. It is a complex scaffold that provides optimal environment for restoration of tissue structure. It guides tissue growth and traps growth factors. Oasis Matrix indications include partial and full thickness wounds and skin loss injuries as well as second-degree burns.
16088685|NCT02246608|Device|Routine NPWT Standard of Care|Specialized material, often foam, designed to protect the wound and promote healing during NPWT.
16088686|NCT02246595|Biological|CaCP29|
16088687|NCT02246595|Biological|Placebo|
16088688|NCT02246582|Device|Enlite 3|Use of Enlite 3 Sensor over 168 hours (7 days) when inserted in the abdomen & arm used with the Guardian Mobile App and 640G Pump in subjects aged 14-75 years who have had a diagnosis of type 1 or type 2 diabetes for at least one year.
16088689|NCT02246582|Device|Guardian Mobile App|
16088690|NCT02246582|Device|640G Insulin Pump|
16088691|NCT02246556|Device|Dichoptic therapy|Dichoptic virtual reality video game therapy with Diplopoia (TM) software developed for the Oculus Rift (R) gaming system
16088692|NCT02246556|Other|Patching therapy|Conventional patching therapy followed by crossover to the dichoptic virtual reality video game therapy with Diplopia (TM) software
16088693|NCT02246556|Device|Dioptic (non-dichoptic) therapy|Dioptic (non-dichoptic) video game therapy followed by crossover to the dichoptic virtual reality video game therapy with Diplopia (TM) software
16088694|NCT02246543|Dietary Supplement|Control|Water, Toast & Egg (Yolk only) + 0.1g 13C Octanoic Acid
16088695|NCT02246543|Dietary Supplement|HPL|High Protein Smoothie (Liquid): 30% protein; 30% fat and 40% CHO + 0.1g 13C Octanoic Acid
16088696|NCT02246543|Dietary Supplement|LPL|Low Protein Smoothie (Liquid): 15% protein; 30% fat and 55% CHO + 0.1g 13C Octanoic Acid
16088697|NCT02246543|Dietary Supplement|HPS|High Protein Milk Jelly (Solid): 30% protein; 30% fat and 40% CHO + 0.1g 13C Octanoic Acid
16088698|NCT02246543|Dietary Supplement|LPS|Low Protein Milk Jelly (Solid): 15% protein; 30% fat and 55% CHO + 0.1g 13C Octanoic Acid
16088699|NCT02246530|Procedure|PRP injection into PTRCT|"Day of procedure, 60 cc blood draw will be taken for processing and isolation of PRP. PRP sample will be injected peri-tendinous / intra-tendinous area at location of the PTRCT under ultrasound guidance to ensure accurate placement at site of injury.
~PRP is an autologous blood product that is being re-injected into the same patient and is considered a non-invasive interventional procedure. PRP is classified as a procedure and not a drug."
16088700|NCT02246530|Drug|Subacromial steroid bursal injection|Combination steroid (Celestone) and anesthetic drug (Lidocaine) will be injected into the patient's subacromial bursa via needle guidance of ultrasound
16088701|NCT02246517|Drug|N2O|
16088702|NCT02246517|Drug|Oxygen|
16088703|NCT02246504|Device|HIFU treatment|
16088704|NCT02246491|Other|A-T iPS cell line|Reprogramming A-T patients iPS cell line
16088705|NCT02246491|Other|Carrier patients iPS cell line|Reprogramming iPS cell line from carrier patients
16088706|NCT02246478|Drug|TAS-205|"Single-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step, single oral administration after meals
~Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 5 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals"
16088707|NCT02246478|Drug|Placebo|"Single-dose phase: 3steps (low dose, middle dose or high dose group), 2 patients/step, single oral administration after meals
~Multiple-dose phase: 3 steps (low dose, middle dose or high dose group), 2 patients/step (the same patients between single- and multiple-dose phases), repeated oral administration for 7 days, BID after meals"
16088708|NCT02246465|Drug|RXI-109|
16088709|NCT02246439|Drug|RHB-102|RHB-102, Bimodal Release Ondansetron Tablets
16088710|NCT02246439|Drug|Placebo Oral Tablet|Placebo
16088711|NCT02246426|Other|Computerized plasticity-based adaptive cognitive training|Computerized plasticity-based adaptive cognitive training for a total maximum of 40 treatment sessions, 3-5 times weekly, 40-60 minutes per session.
16088712|NCT02246426|Other|Commercially available computerized training|Commercially available computerized training for a total maximum of 40 treatment sessions, 3-5 times weekly, 40-60 minutes per session.
16088713|NCT02246413|Behavioral|RAINBOW Intervention Program|Integrated lifestyle intervention with as-needed antidepressant pharmacotherapy to treat coexisting obesity and depression in adults in primary care
16088714|NCT02246400|Behavioral|eCMP|eCMP is a 6-month lifestyle intervention designed and led by a team of experienced health professionals, including physicians, researchers, dietitians, and registered nurses. The program consists of weekly home and class activities delivered through online or take-home videos, video conferencing, and/or in-person sessions.
16088715|NCT02246387|Procedure|Manchester Operation|A 3- compartment native tissue repair procedure for Pelvic Organ Prolapse.
16088716|NCT02246374|Device|ExAblate Transcranial System|ExAblate Transcranial System subthalamotomy for symptoms of Parkinson's Disease
16088717|NCT02246361|Procedure|Patient Information Leaflet (PIL)|Patient Information Leaflet (PIL) about infectious colitis, diverticulitis, pneumonitis, prostatitis or either pyelonephritis is given to the patient related to his disease during the consultation
16088718|NCT02246348|Radiation|Doppler ultrasound|Recording Doppler ultrasound noninvasively from the right chest wall
16088719|NCT02246335|Device|Cemented total hip arthroplasty|
16088720|NCT02246335|Device|Cemented hemiarthroplasty|
16088721|NCT02246322|Device|25G needle|All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B).
16088722|NCT02246322|Device|22G needle|All consecutive patients that will be referred for solid masses to be aspirated will be randomized to be targeted in the 25G needle arm (A), or in the 22G needle arm (B).
16088723|NCT02246309|Device|Embryoscope Time Lapse System|The EmbryoScope® time-lapse system is a unique platform facilitating improved IVF treatment, flexible work routines and effective communication, through comprehensive documentation of embryo development and evolving improvements in selection.
16088724|NCT02246309|Device|Standard Embryo Culture|Standard embryo culture in a Standard water jacketed carbon dioxide/low oxygen incubator system.
16088725|NCT02246296|Dietary Supplement|Standard F75 Milk|This is the standard F75 milk used worldwide (Control group)
16088726|NCT02246296|Dietary Supplement|Modified F75 Milk|This is the experimental group
16088727|NCT02246270|Drug|Intravesical Heparin|Heparin bladder instillation
16088728|NCT02246270|Other|Placebo|Intravesical saline
16088729|NCT02246257|Other|Simvastatin|LDL > 2.5 is treated with 40 mg
16088730|NCT02246257|Other|Losartan|BT > 140/90 mmHg treated with 50 mg OD
16088731|NCT02246257|Other|Losartan|DM BT > 130/80 mmHg treated with 50 mg OD
16088732|NCT02246257|Other|Losartan|Microalbuminuria (urinary albumin creatinin ratio > 30 mg) treated with 100 mg OD
16088733|NCT02246257|Other|Metformin|HBA1C > 48 mmol/mol treated with 500 mg increased dose to 2,000 mg in 4 weeks
16088734|NCT02246257|Other|Outpatient rheumatology department|(4 times yearly)
16088735|NCT02246257|Other|Refered to general practice|
16088736|NCT02246244|Drug|Escitalopram|
16088737|NCT02246244|Other|Placebo|
16088738|NCT02246231|Device|MR imaging|
16088739|NCT02246218|Drug|RAVICTI|
16088822|NCT02245516|Drug|KPI-121 0.25% Ophthalmic Suspension|KPI-121 drug product will be supplied a 0.25% loteprednol etabonate as a suspension packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
16088740|NCT02246205|Procedure|Pancreaticoduodenectomy|Pancreaticoduodenectomy is the classical operative technique to resect cephalic pancreatic cancer. In a first phase of the surgery, the resection may be performed. In the second phase, the digestive tract must be restored. We planify two different reconstruction techniques.
16088741|NCT02246192|Procedure|sinus pilonidal excision+ PRGF|open sinus pilonidal excision and plasma rich grow factor infiltration intra and postoperatively
16088742|NCT02246192|Procedure|sinus pilonidal excision and standard cares|sinus pilonidal excision and postoperative standard care with povidone daily
16088743|NCT02246179|Device|AFXL|Pretreatment at 2.5 mJ/microbeam and 5% density Pain stimulus at 35 mJ/microbeam and 5% density
16088744|NCT02246179|Drug|AHES|Topical application at test region 1 and 3 under occlusion for 10 minutes
16088745|NCT02246179|Drug|EMLA cream|Topical application at test region 2 and 4 under occlusion for 10 minutes
16088746|NCT02246166|Drug|Test tablet|The active tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity
16088747|NCT02246166|Other|Placebo|The placebo tablet will be administered orally. Product administration will occur within 30mins of the baseline assessment of symptom severity
16088748|NCT02246153|Procedure|Laparoscopic gastrectomy|"After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, laparoscopic distal subtotal gastrectomy and D2 lymph node dissection will be performed with curative treated intent.
~The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy."
16088749|NCT02246153|Procedure|Open gastrectomy|"After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, open distal subtotal gastrectomy and D2 lymph node dissection will be performed with curative treated intent.
~The type of reconstruction will be selected according to the surgeon's experience."
16088750|NCT02246140|Other|Cerebral MRI and MRA|
16088751|NCT02246127|Drug|Drug: Everolimus|10mg/daily, oral. Number of Cycles: until progression or unacceptable toxicity develops.
16088752|NCT02246127|Drug|STZ-5FU|"0,5g/m2 STZ on days 1-5 and 400mg/m2 5-FU on days 1-5 every 6 weeks (Moertel) or 0,5g/m2 STZ on days 1-5 and 400mg/m2 5-FU on days 1-3, and then 1 day with 1g/m2 and 1 day 400mg/m2 5-FU every 3 weeks (Uppsala).
~Number of Cycles: until progression or unacceptable toxicity develops."
16088753|NCT02246114|Device|piCO+ Smokerlyzer® monitor|
16088754|NCT02246114|Other|Text messages|
16088755|NCT02246088|Procedure|MT + NE|"Manual therapy will be applied using mobilization with movement (MWM) techniques. MWM will consist of a sustained manual glide of the tibia (either medial, lateral, anterior, posterior, or rotation) during active knee flexion and extension, depending on which are the limited/painful movements for each patient.
~The content and pictures of the neuroscience education (NE) will be based on the text Explicando el dolor (Spanish version of Explain Pain)."
16088756|NCT02246088|Procedure|MT + E|Program of education based on the traditional biomedical model (i.e. through visualization of several videos related to anatomy, biomechanics and surgical procedure of the knee), plus the same manual treatment as per the MT+NE group
16088757|NCT02246075|Drug|EVP-6124|
16088758|NCT02246062|Behavioral|info|the relative received leaflet containing information about the anesthetic procedure one day before the surgery at ward.
16088759|NCT02246062|Behavioral|smartphone|the child received smartphone application immediately before entering the operating room
16088760|NCT02246049|Biological|Bevacizumab|Given IV
16088761|NCT02246049|Drug|5-fluorouracil|Given IV
16088762|NCT02246049|Drug|Irinotecan hydrochloride|Given IV
16088763|NCT02246049|Drug|Leucovorin calcium|Given IV
16088764|NCT02246049|Drug|Oxaliplatin|Given IV
16088765|NCT02246036|Device|APD probe|The probe will be placed in the patient with an endoscopic procedure by a gastroenterologist (standard procedure for post-pyloric tubes placement).
16088766|NCT02246023|Device|Flexible bronchoscopy in moderate sedation|Flexible bronchoscopy for diagnosis of lung cancer, sarcoidosis or interstitial pneumonia in moderate sedation with propofol;
16088767|NCT02246023|Device|Oxygen saturation|Continuous measurement of oxygen saturation;
16088768|NCT02246023|Device|Blood pressure|Measurement of non-invasive blood pressure every 3 minutes
16088769|NCT02246023|Device|Propofol dosage|Report of dose adjustments und cumulative propofol dosage;
16088770|NCT02246023|Device|Recovery time after bronchoscopy|Recovery time after bronchoscopy from removal of bronchoscope to eye opening/answer to verbal stimuli (whatever comes first)
16088771|NCT02246010|Dietary Supplement|Lactose- free milk|Lactose- free milk
16088772|NCT02245997|Radiation|External beam radiotherapy|
16088773|NCT02245997|Radiation|proton beam RT|
16088774|NCT02245984|Other|paper based nursing process|for two weeks, students in paper based nursing group will be implemented paper nursing process for patients.
16088775|NCT02245984|Other|electronic nursing process|for each of the groups separately-training program aimed to education the nursing process and how to do it (including the definition of the nursing process, advantages and its implementation and how to collect data using patient assessment forms Gordon) in the form of workshops a day (5 hours) will be implemented. Nursing process education in the two groups will similar but two hours of the program in each groups is devoted to practical training on how to implement. After completing the training program, students learn about the nursing process will be determined in the same way. Then for two weeks, students in Group A and Group B will be implemented paper and electronic nursing process for patients.
16088776|NCT02245971|Procedure|Partial precutting|Partial precutting will be performed prior to dissection during the ESD.
16088777|NCT02245971|Procedure|Whole precutting|Whole precutting will be performed prior to dissection during the ESD.
16088778|NCT02245958|Other|No Intervention|No treatment (intervention) was administered.
16088779|NCT02245945|Drug|TFV 1% vaginal gel|Tenofovir 1% gel is supplied as a clear, transparent, viscous gel packaged in pre-filled single use applicators. Each applicator contains 4.0 mL of tenofovir gel (equal to 4.4 gm) at a concentration of 1% (weight for weight) formulated in purified water with edetate disodium, citric acid, glycerin, methylparaben, propylparaben and hydroxyethylcellulose, and is pH adjusted to 4-5.
16088863|NCT02245269|Drug|Tipranavir|
16088864|NCT02245269|Drug|Ritonavir|
16088865|NCT02245269|Drug|Atorvastatin|
16088780|NCT02245945|Drug|HEC Placebo Gel|Placebo gel contains hydroxyethylcellulose (HEC) as the gel thickener, purified water, sodium chloride, sorbic acid and sodium hydroxide. The gel is isotonic and formulated at a pH of 4.4. Each pre-filled applicator will contain approximately 4 mL of placebo gel for delivery.
16088781|NCT02245932|Dietary Supplement|Resveratrol|4 weeks of 150 mg resveratrol (2 times 75mg/day)
16088782|NCT02245932|Dietary Supplement|Placebo|4 weeks of placebo supplementation (two doses per day)
16088783|NCT02245919|Other|Back on Track intervention|A biopsychosocial primary care intervention based on multidisciplinary pain rehabilitation programs. The Back on Track intervention comprises 4 individual sessions and 8 group sessions.
16088784|NCT02245906|Dietary Supplement|Control drink|As a control, subjects are asked to consume 300 ml control drinks containing equal amount of total fiber and pectine as Brazilian fruit drink. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.
16088785|NCT02245906|Dietary Supplement|Brazilian fruit peel flour|In this study, subjects are asked to consume 300 ml beverage drinks contain certain amounts of Brazilian fruit peel flour. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.
16088786|NCT02245906|Dietary Supplement|Negative control drink|As a negative control, subjects are asked to consume 300 ml control drinks without containing amount of total fiber and pectine as Brazilian fruit drink. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.
16088787|NCT02245893|Procedure|open reduction internal fixation (ORIF)|The study design is a prospective, randomized pilot clinical trial of the treatment of unstable syndesmosis injuries sustained with Weber C type fractures. Comparison will be made between two syndesmosis stabilization methods: 1) Percutaneous (closed) reduction using syndesmosis fixation by SCREW 2) Open reduction (ORIF) with ART repair of the anterior ligament and stabilization of the syndesmosis by use of a syndesmosis screw.
16088788|NCT02245880|Device|Glidescope|videolaryngoscope
16088789|NCT02245880|Device|ILMA|handling of the device till the optimal ventilation achieved
16088790|NCT02245867|Drug|Chimeric Fibril-Reactive Monoclonal Anti-body 11-1F4|The antibody binds to the pathologic material and initiates a neutrophil/macrophage response
16088791|NCT02245854|Device|Exacto™|Cold snare polypectomy
16088792|NCT02245841|Drug|H.P. Acthar Gel|80 U (1 mL) of H.P. Acthar gel via subcutaneous injection twice weekly for 24 weeks
16088793|NCT02245828|Drug|QCC374|Single and multiple ascending doses of QCC374
16088794|NCT02245828|Drug|Placebo|Placebo comparator
16088795|NCT02245815|Dietary Supplement|use probiotics boucardii|group A was administered the lactobacillus acidophilus boucardii probiotic (1x10⁹ colonies forming units (UFC) per day for 3 weeks). The diagnosis of (NEC) was made using the Bell criteria by the attending physician. Gastric tolerance was measured, the number and the characteristics of the feces before and after the administration of the probiotic, and also the levels of (IgA s) was measured at the beginning and at the end of treatment.
16088796|NCT02245815|Dietary Supplement|use probiotics Multi-species|Group B was administered multi-species probiotic (1x10⁹colonies forming units (UFC) per day for 3 weeks). The diagnosis of (NEC) was made using the Bell criteria by the attending physician. Gastric tolerance was measured, the number and the characteristics of the feces before and after the administration of the probiotic, and also the levels of (IgA s) was measured at the beginning and at the end of treatment.
16088797|NCT02245789|Procedure|Tracheal intubation|Tracheal intubation will be performed using a Macintosh laryngoscope or a McGrath Mac videolaryngoscope
16088798|NCT02245789|Drug|Propofol and remifentanil anesthesia|The standardized anesthetic procedure used a closed-loop anesthesia system with bispectral index as control variable and with two proportional-differential control algorithms, one for propofol target-controlled infusion system and one for remifentanil target-controlled infusion system.
16088799|NCT02245776|Biological|Stem Cell|Intrathecal autologous bone marrow mononuclear cell transplantation
16088800|NCT02245763|Device|Leaflet Clip|
16088801|NCT02245750|Device|Hysteroscopy|hysteroscopy and endometrial injury prior to the IVF/ICSI cycle
16088802|NCT02245737|Drug|Lanabecestat|Administered orally
16088803|NCT02245737|Drug|Placebo|Administered orally
16088804|NCT02245724|Biological|Stem Cell|Autologous bone marrow mononuclear cell transplantation
16088805|NCT02245711|Biological|Stem Cell|
16088806|NCT02245698|Biological|Stem cell|Intrathecal autologous bone marrow mononuclear cell transplantation
16088807|NCT02245672|Drug|MGR001 (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate)|Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the CRC749 inhaler device
16088808|NCT02245672|Drug|Advair (Fixed dose combination of Fluticasone propionate and salmeterol xinafoate)|Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered via the Diskus inhaler device
16088809|NCT02245672|Drug|Placebo|Placebo administered via the CRC749 and Diskus devices
16088810|NCT02245659|Device|CPAP|Continuous Positive Airway Pressure
16088811|NCT02245659|Other|Nasal dilator strip|Nasal dilator strip to be worn nightly
16088812|NCT02245620|Drug|Elamipretide|Elamipretide 0.25 mg/kg/hour administered as an intravenous infusion at the rate of 60 mL/hour for 2 hours
16088813|NCT02245620|Drug|Placebo|Placebo administered as intravenous infusion at a rate of 60 mL/hour for 2 hours
16088814|NCT02245607|Behavioral|Compensatory Cognitive Training|
16088815|NCT02245607|Behavioral|Recreational Therapy|
16088816|NCT02245581|Procedure|SVV-guided fluid management|
16088817|NCT02245581|Procedure|CVP-guided fluid management|
16088818|NCT02245568|Drug|LMTM|The initial LMTM dose was 200 mg/day (one 100-mg tablet twice daily), except in subjects with bvFTD who were taking a reduced dose (i.e., 100 mg/day) upon entering this extension study. The dose could be increased (after at least 13 weeks of treatment) or decreased (at any time at or after 2 weeks of treatment) by the Investigator in 100-mg increments or decrements. The maximum allowable dose was 300 mg/day (or in those countries where limited by a Competent Authority or Ethics Committee, 200 mg/day).
16088819|NCT02245555|Drug|Tamsulosin|
16088820|NCT02245542|Drug|ALNA®OCAS®|
16088821|NCT02245529|Drug|Tamsulosin|
16088866|NCT02245269|Drug|Maalox|Aluminum Hydroxide; Magnesium Hydroxide; Simethicone
16088823|NCT02245516|Drug|KPI-121 1.0% Ophthalmic Suspension|KPI-121 drug product will be supplied a 1.0% loteprednol etabonate as a suspension packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
16088824|NCT02245503|Drug|Tamsulosin|
16088825|NCT02245490|Drug|Tamsulosin HCl controlled release capsules|
16088826|NCT02245490|Drug|Matching placebo capsule|
16088827|NCT02245477|Device|obstetric Ultrasound|Transabdominal ultrasound was performed to confirm foetal number, viability, gestational age, exclusion of congenital anomalies, and assessment of amniotic fluid index and localization of the placenta.
16088828|NCT02245477|Other|serum Vascular Endothelial Growth Factor|Maternal blood samples (10 cc) were taken from an antecubital vein. Plastic clean sterile tubes were used for collection of blood. Two cc of the blood sample were put in other clean sterile tubes containing ethylene diamine tetra-acetic acid (EDTA) to be used in measuring maternal hemoglobin concentrations and evaluating the complete blood count. The rest of maternal blood samples were centrifuged within 3 hours and sera collected equally in 2 suitable containers and stored at -80 degrees until assayed (first container for routine laboratory investigations and the second for VEGF assay).VEGF sample was allowed to clot for 30 minutes before centrifugation for 15 minutes. Serum is removed and assay immediately or sample was stored at -80 degrees
16088829|NCT02245464|Drug|Telmisartan|
16088830|NCT02245451|Drug|Tipranavir|
16088831|NCT02245451|Drug|Ritonavir|
16088832|NCT02245451|Drug|Methadone|
16088833|NCT02245438|Drug|Tipranavir low dose|
16088834|NCT02245438|Drug|Tipranavir high dose|
16088835|NCT02245438|Drug|Ritonavir low dose|
16088836|NCT02245438|Drug|Ritonavir high dose|
16088837|NCT02245438|Drug|Norethindrone-Ethinyl Estradiol|
16088838|NCT02245425|Other|Supine Thoracic Spine Manipulation|Position patient so that small amplitude quick stretch can be applied to the least mobile area of the thoracic spine that is identified during the spinal segmental mobility testing. The thoracic spine thrust manipulation will be applied at an appropriate range of motion as identified by the clinician.
16088839|NCT02245425|Other|Prone Thoracic Spine Manipulation|Position patient so that small amplitude quick stretch can be applied to the least mobile area of the thoracic spine that is identified during the spinal segmental mobility testing. The thoracic spine thrust manipulation will be applied at an appropriate range of motion as identified by the clinician.
16088840|NCT02245412|Biological|ALXN1007 10 mg/kg once weekly|ALXN1007 is a recombinant humanized monoclonal antibody that binds to complement component C5a and its metabolite C5a desArg.
16088841|NCT02245412|Biological|ALXN1007 20 mg/kg once weekly|ALXN1007 is a recombinant humanized monoclonal antibody that binds to complement component C5a and its metabolite C5a desArg.
16088842|NCT02245412|Biological|ALXN1007 20 mg/kg twice weekly|ALXN1007 is a recombinant humanized monoclonal antibody that binds to complement component C5a and its metabolite C5a desArg.
16088843|NCT02245399|Behavioral|A canola oil enriched mediterranean diet|The diet will be provided at 60% of calories estimated for stable body weight to encourage weight loss. A high protein canola oil-enriched test bread will be provided as a supplement.
16088844|NCT02245399|Behavioral|A high wheat fiber diet|The diet will be provided at 60% of calories estimated for stable body weight to encourage weight loss. A whole wheat control bread will be provided as a supplement to participants
16088845|NCT02245386|Radiation|transperineal pelvic floor ultrasound|"Transperineal pelvic floor ultrasound applied for the submitted 120 women primiparae (40 women after normal vaginal delivery), (40 women after urgent cesarean section), (40 women after elective cesarean section), in early postpartum period (48 to 72) hours postpartum, to evaluate levator ani morphology."
16088846|NCT02245373|Drug|Antidepressants|
16088847|NCT02245373|Other|Active Monitoring|
16088848|NCT02245360|Drug|Phleum pratense grass pollen allergen extract|Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days
16088849|NCT02245360|Drug|placebo|placebo tablet given once daily over 60 days
16088850|NCT02245334|Drug|Povidone-Iodine|1 pill per biopsy
16088851|NCT02245321|Dietary Supplement|Ferrous gluconate- 19 mg|Receive pills to take daily that contain 19 mg of iron (the typical amount in a multivitamin with iron).
16088852|NCT02245321|Dietary Supplement|Ferrous gluconate- 38 mg|Receive pills to take daily that contain 38 mg iron (the typical amount in an over-the-counter iron supplement).
16088853|NCT02245321|Other|Letter Group- Information Provided|Receive a letter informing them of their ferritin result at each visit, along with recommendations for blood donation.
16088854|NCT02245321|Other|Letter - No Information Provided|Receive a letter thanking the participant for their participation.
16088855|NCT02245321|Dietary Supplement|Placebo|Receive pills to take daily that contain 0 mg iron.
16088856|NCT02245308|Drug|Nicotine Patches|Nicotine replacement therapy in the form of nicotine patches will be provided to ART group participants beginning on their smoking quit date. Nicotine patches may be provided to control group participants as part of usual care.
16088857|NCT02245308|Behavioral|mobile contingency management (mCM)|Mobile contingency management (mCM) is a behavioral intervention designed to provide positive reinforcement for remaining abstinent from smoking. In this intervention, participants are loaned a smart phone equipped with a videocamera and a carbon monoxide (CO) monitor. Participants are trained to upload videos of themselves taking CO readings. Any time a participant uploads a video recording that suggests abstinence (i.e., low CO reading), he/she will be provided a monetary reward.
16088858|NCT02245308|Behavioral|Smoking cessation counseling|Smoking cessation counseling is a cognitive-behavioral treatment designed to prepare participants for a quit attempt, and to address relapse when necessary.
16088859|NCT02245308|Drug|Nicotine rescue method|Nicotine replacement therapy in the form of nicotine gum or lozenges will be provided to ART group participants beginning on their smoking quit date. Nicotine gum or lozenges may be provided to control group participants as part of usual care.
16088860|NCT02245308|Drug|Bupropion|Bupropion SR may be prescribed to medically eligible ART group participants beginning one week prior to quit date. Bupropion may also be prescribed to control group participants as part of usual care.
16088861|NCT02245295|Procedure|Moderate Sedation for EBUS/TBNA|EBUS-TBNA was performed by one of the pulmonologists in moderate sedation (D.F., M.K.).
16088862|NCT02245295|Procedure|General anesthesia for EBUS/TBNA|EBUS-TBNA was performedin general anaesthesia by one of the thoracic surgeons (D.S., P.K.)
16088869|NCT02245243|Drug|Delafloxacin|Plasma pharmacokinetic parameters: AUC0-t, AUC0 inf, Cmax, Tmax, λz, t1/2, MRTinf, CL, CLnr, Vss, Vz
16088870|NCT02245230|Drug|Angiotensin (1-7)|Angiotensin (1-7) is a peptide produced by the body. It will be administered as an acute intravenous infusion with doses ranging from 0.5 to 20 ng/kg/min.
16088871|NCT02245230|Drug|Trimethaphan|Trimethaphan is a Nn-nicotinic receptor antagonist that blocks sympathetic and parasympathetic transmission at the level of the autonomic ganglia. It will be administered as an acute intravenous infusion with doses ranging from 0.5 to 5.0 mg/min.
16088872|NCT02245230|Drug|Phenylephrine|Phenylephrine is an alpha 1-adrenergic agonist. It will be administered as an acute intravenous infusion to restore blood pressure following trimethaphan with doses ranging from 0.1 to 0.5 ug/kg/min.
16088873|NCT02245217|Device|PET/CT scan to assess treatment efficacy|
16088874|NCT02245204|Drug|Chlorogenic acid|Chlorogenic acid for injection is polyphenols, micromolecular and un-endogenous substance. It might play the role of cancer treatment via balancing tumor micro-environmental immune status according to the stability and rationality of immunodeficiency and endogenous immune material expression around the tumor. Chlorogenic acid for injection is made from chlorogenic acid (purity≥98%) which is extracted from folium cortex eucommiae.Chlorogenic acid and its preparations have not been reported as chemical drug and marketed around the world.
16088875|NCT02245191|Drug|Ephedrine|5mg after Spinal Anesthesia
16088876|NCT02245191|Drug|Phenylephrine|100mcg after Spinal Anesthesia
16088877|NCT02245191|Drug|Metaraminol|200mcg Metaraminol after Spinal Anesthesia
16088878|NCT02245178|Procedure|Lung spirometry|measurement of pulmonary function pre- and post-bronchodilator
16088879|NCT02245178|Other|CT scan analysis|Analysis of existing year 25 thoracic CT scans for lung and intrathoracic vascular structure
16088880|NCT02245165|Biological|L-Nitro-Monomethyl-Arginine (LNMMA) 10 mg/kg IV|
16088881|NCT02245165|Biological|saline|
16088882|NCT02245152|Dietary Supplement|LNS|A monthly dose of LNS (31 sachets of 20g) will be distributed to mothers attending well-baby visits and participating in small group counseling
16088883|NCT02245152|Behavioral|Child's health and nutrition topics|"After the well-baby visit. Caregivers will be invited to participate in a small group counseling or BCC (2-3 caregivers at a time).
~Every month a set of topics related to child's health and nutrition will be treated. These BCC sessions will be organized in an interactive way centering around the condition of the participating children."
16088884|NCT02245152|Behavioral|National policy well-baby visits|
16088885|NCT02245126|Drug|3-3-4 mix|the drug mix included lidocaine, bupivacaine and water for injection
16088886|NCT02245126|Drug|4-4-2|In this group (4-4-2 group) eligible men were receiving an injection of the 4-4-2 local anesthetic mix ( composed of 4cc of parental lignocaine 2%, 4cc of parental bupivacaine 0.5% and 2cc of water for injection). This mix is given once before commencement of the surgical procedure safe male circumcision.
16088887|NCT02245113|Other|diets|Feeding trial for 6 weeks (week 0 - baseline). The experimental diets are comprised of 30% kcal fat, 15% kcal protein and 55% kcal carbohydrate. Each of the test fat contributes to two-thirds of total dietary fat will be compared.
16088888|NCT02245100|Other|Cytology specimen|Correlative studies
16088889|NCT02245100|Other|Laboratory biomarker analysis|Correlative studies
16088890|NCT02245087|Drug|Atorvastatin|20 mg of atorvastatin daily
16088891|NCT02245074|Other|Sputum induction|The sputum induction will be performed by repeated nebulizations of 3% saline hypertonic solution. Cellularity and cell profiles were analysed as previously recommended.
16088892|NCT02245061|Other|paired pulses cortical electrical stimulation|
16088893|NCT02245048|Other|Carotid Intima-Media Thickness (CIMT)|
16088894|NCT02245022|Drug|Dolutegravir 50mg od|Patients randomised to receive either Dolutegravir 50mg od or standard of care (Efavirenz 600mg od) plus Lamivudine 300mg od/ Tenofovir 300mg od
16088895|NCT02245022|Drug|Standard of Care|Patients are randomised 1:1 to receive either Dolutegravir 50mg once daily in combination with Lamivudine 300mg od and tenofovir 300mg od or standard of care (Efavirenz 600mg plus Lamivudine 300mg od and tenofovir 300mg od)
16088896|NCT02245009|Procedure|Cardioversion|
16088897|NCT02244996|Dietary Supplement|Lycium Barbarum|Traditional Chinese Herbs
16088898|NCT02244996|Dietary Supplement|Placebo|Placebo
16088899|NCT02244983|Other|Patients History|History taking and drawing of a blood sample
16088900|NCT02244970|Other|Mindfulness|Mindfulness is the awareness that emerges from paying attention to the present moment without judgment. In this study, subject in this arm will receive 7 weeks of MBI with a focus on tackling anxiety, depressed mood, and attention deficits among early psychosis participants. The elements of 7-week program included mindful-breathing, indoor and outdoor mindful-walking, mindful-eating, mindul-drawing, tree-of-life exercise and closing celebration.
16088901|NCT02244970|Other|Psychoeducation|Participants in the psychoeducation group will receive seven weeks of psychoeducation sessions which include basic knowledge related to 1) General mental health, 2) Knowledge of psychosis, 3) Treatment and community resources, 4) Recovery and relapse prevention, 5) Healthy lifestyle, 6) Social skills training, and finally a closing celebration at week 7.
16088902|NCT02244957|Device|Bi-level positive airway pressure (BPAP)|Overlap patients randomized to BPAP will be titrated as per American Academy of Sleep Medicine (AASM) guidelines and oxygen if needed based on saturations <88% while on stable bi-level settings.
16088903|NCT02244957|Drug|Nocturnal oxygen|Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.
16088904|NCT02244944|Drug|EZ-Urso combination therapy|Ursodiol 13-15 mg per kg per day combined with Ezetimibe (Zetia) 10 mg per day
16088905|NCT02244931|Device|Servomatic™ assisting device|Servomatic™ is an hand controlled motorized device assisting to propel the wheelchair .
16088906|NCT02244931|Device|E.Motion© assisting device|E.Motion© is an hand controlled motorized device assisting to propel the wheelchair .
16088907|NCT02244931|Device|Standard manual Wheelchair|Standard manual Wheelchair
16088908|NCT02244918|Drug|Nicotine Replacement Therapy|Participant has choice of from over-the-counter nicotine patch, nicotine gum or lozenge.
16088909|NCT02244918|Behavioral|Smoking Cessation Counseling|
16088950|NCT02244554|Device|enLighten Laser|Picosecond pulse-duration or Nanosecond pulse-duration tattoo treatment with enLighten Q-switched Laser Treatment
16088910|NCT02244905|Behavioral|Positive Deviance|The recipients of the Positive Deviance intervention are the staff members of the three wards in the intervention arm, while the outcomes are measured among the patients receiving care in the three wards in the intervention arm. Key components of the intervention were invitation to participate voluntarily, open-ended dialogues with staff members to discover barriers and seek solutions to prevent HAI, discussion of outcomes, and encouragement to prioritize and implement the solutions generated.
16088911|NCT02244905|Other|Standard-of-Care Infection Control approach|Standard-of-Care Infection Control approach
16088912|NCT02244879|Dietary Supplement|resveratrol|arm resveratrol 500: 6 months of resveratrol 500 mg/day arm resveratrol 40: 6 months of resveratrol 40 mg/day
16088913|NCT02244866|Drug|Pergoveris (FSH and LH)|Drugs are injected subcutaneously everyday until ovarian follicles reach 17mm in diameter.
16088914|NCT02244866|Drug|Follitropin alpha (FSH)|Drugs are injected subcutaneously everyday until ovarian follicles reach 17mm in diameter.
16088915|NCT02244840|Device|Electronic bidet|commercial electronic bidet
16088916|NCT02244840|Device|Sitz bath|Conventional sitz bath
16088917|NCT02244827|Drug|WCK 2349|levonadifloxacin (active drug) and the sulfate metabolite
16088918|NCT02244814|Behavioral|Low Carbohydrate/Conventional|Lower-carbohydrate/conventional diet (usual care)
16088919|NCT02244814|Behavioral|Choosing Healthy Options in Carbohydrate Energy|Choosing Healthy Options in Carbohydrate Energy
16088920|NCT02244801|Drug|darTreg infusion|"The first subject in each dosing cohort will be monitored for 4 weeks after darTreg infusion. Following the 4 week observation period, the study team will conduct a thorough review of all available data to ensure that there are no safety signals and to make a determination about proceeding with additional patients. sBc production for darTreg manufacturing for the second subject in each cohort may be initiated but the second subject may not undergo leukapheresis until the safety review is complete.
~Once the last subject in the first cohort reaches week 4 post-infusion, the DSMB will conduct a thorough review of all available data to make a determination about proceeding with additional patients at the lower dose or proceeding to the second dosing cohort. sBc production for darTreg manufacturing for the subsequent subject may be initiated but the patient may not undergo leukapheresis until the DSMB( Data Safety and Monitoring Board ) has approved enrollment of subsequent subjects."
16088921|NCT02244788|Device|SR™ PIP|
16088922|NCT02244775|Device|SR™MCP|
16088923|NCT02244762|Drug|20 mg HC-ER|1-72 hours
16088924|NCT02244762|Drug|20 mg HC-ER|1-72 hours
16088925|NCT02244762|Drug|20 mg HC-ER|1-72 hours
16088926|NCT02244749|Other|skin specimen|skin specimen
16088927|NCT02244723|Other|Lung ultrasound examination|Lung ultrasound (LUS) is increasingly being used at the bedside for assessing alveolar-interstitial syndrome, lung consolidation, pneumonia, pneumothorax, and pleural effusion. It could be an easily repeatable noninvasive tool for diagnosis of ventilator associated pneumonia
16088928|NCT02244710|Drug|Ticagrelor vs Clopidogrel|
16088929|NCT02244671|Procedure|fat, PRP, botulinum toxin|fat injection with platelet-rich-plasma (PRP) after immobilizing the extraocular muscles with botulinum toxin
16088930|NCT02244671|Drug|botulinum toxin|botulinum toxin used to immobilize extra-ocular muscles prior to fat injection.
16088931|NCT02244671|Device|PRP|autologous PRP is prepared with a dedicated centrifuge at the time of fat harvesting
16088932|NCT02244658|Drug|rhTPO|rhTPO 1.0 μg/kg·d subcutaneously for 7~14 consecutive days
16088933|NCT02244645|Behavioral|passive modality|Passive modality control group will receive regular 40-minutes rehabilitation twice a week for 3 months.
16088934|NCT02244645|Behavioral|Yoga treatment|Yoga treatment group will receive regular 60-minutes yoga classes twice a week for 4 months.
16088935|NCT02244632|Drug|Modufolin (arfolitixorin)|IV injection every second week for 8 weeks.
16088936|NCT02244632|Drug|Fluorouracil|IV injection every second week for 8 weeks.
16088937|NCT02244632|Drug|Oxaliplatin|IV infusion every second week for 8 weeks.
16088938|NCT02244632|Drug|Irinotecan|IV infusion every second week for 8 weeks.
16088939|NCT02244632|Drug|Bevacizumab|IV infusion every second week for 8 weeks.
16088940|NCT02244619|Drug|Oral acetaminophen|Subjects randomized to the Oral acetaminophen arm will receive 2 Tylenol 500mg capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving Oral acetaminophen will also receive 100ml of IV Normal Saline similar to the delivery method of the IV acetaminophen arm. The Normal Saline IV placebo will be given not as an intervention but rather as a method to maintain study integrity.
16088941|NCT02244619|Drug|IV acetaminophen|Subjects randomized to the IV acetaminophen arm will receive Ofirmev 1000mg in 100ml Normal Saline IV plus 2 placebo capsules. In this study, one arm receives an oral form of active medication and one arm receives an IV form of active medication. To keep the subject and study personnel blinded, subjects receiving IV acetaminophen will also receive 2 placebo capsules similar to the delivery method of the oral acetaminophen arm. The placebo capsules will be given not as an intervention but rather as a method to maintain study integrity.
16088942|NCT02244606|Drug|SCY-078|
16088943|NCT02244606|Drug|Fluconazole|
16088944|NCT02244606|Drug|Micafungin|
16088945|NCT02244593|Other|FAST MRI and mammography screening|Patients in this group will receive Breast MRI and annual mammography. Participants will complete 4 questionnaires at 3 time points: enrollment; 2 weeks after they receive their mammogram; 6 months after their mammogram.
16088946|NCT02244580|Device|MammaTyper™|MammaTyper™ kit is a molecular in vitro diagnostic test for the quantitative detection of the ribonuclease acid (RNA) expression status of the genes for estrogen receptor (ESR1), progesterone receptor (PGR), human epidermal growth factor receptor 2 (HER2) and proliferation antigen KI 67.
16088947|NCT02244567|Drug|Metformin 850 mg twice daily for 3 months|This drug is insulin sensitizing agent which will be given twice daily orally for 3 months for PCOS patients.
16088948|NCT02244567|Procedure|Serum uc-oc|Serum uc-oc is a bone biomarker involved in incraesing insulin in pathophysiology of PCOS. It will be measured in serum of pcos patients before and after treatment with metformin for 3 months.
16088949|NCT02244567|Other|drug|This group of patients will receive any type of vitamin as a placebo to compare with effect of Metformin on serum UC-OC.
16088951|NCT02244541|Drug|ANAVEX2-73 Oral|
16088952|NCT02244541|Drug|ANAVEX2-73 Intravenous|
16088953|NCT02244541|Drug|ANAVEX2-73 Oral|30 mg hard gelatin capsule
16088954|NCT02244541|Drug|ANAVEX2-73 Oral|50 mg hard gelatin capsule
16088955|NCT02244528|Drug|Sildenafil|
16088956|NCT02244515|Drug|dexmedetomidine|dexmedetomidine 0.5μg•kg-1 diluted in 10 ml NaCI 0.9%
16088957|NCT02244502|Device|NovoTTF-100L(O)|Patients will be treated continuously with the NovoTTF-100L(O). NovoTTF-100L(O) treatment will consist of wearing four electrically insulated electrode arrays on the torso. The treatment enables the patient to maintain regular daily routine.
16088958|NCT02244502|Drug|Paclitaxel|Paclitaxel 80 mg/m2 over 1 hour infusion will be administered weekly for 8 weeks and then on days 1, 8, 15 of each subsequent 28 day cycle.
16088959|NCT02244489|Drug|Momelotinib (MMB)|Momelotinib (MMB) tablet(s) administered orally once or twice daily
16088960|NCT02244489|Drug|Capecitabine|Capecitabine tablet(s) administered orally twice daily for 14 days, followed by 7 days off, until the end of treatment
16088961|NCT02244489|Drug|Oxaliplatin|Oxaliplatin administered intravenously over 120 minutes or as per institutional standard of care on Day 1 of each 21-day cycle.
16088962|NCT02244463|Drug|MLN0128|This is a non-randomized phase II study to investigate efficacy of MLN0128 in metastatic anaplastic thyroid cancer cases.
16088963|NCT02244450|Biological|SCID screening|
16088964|NCT02244437|Drug|Ibuprofen|
16088965|NCT02244437|Drug|Acetaminophen|
16088966|NCT02244424|Behavioral|Tools for Teen Moms|"The Tools for Teen Moms intervention is a novel social media intervention platform designed by the investigators which includes cell phone text message reminders, and infant feeding website, and Facebook to increase infant-centered feeding through daily behavioral challenge activities (challenges) for this population. The intervention consists of 6 weeks of daily challenges and will be delivered within the infant's first 6 months of life."
16088967|NCT02244411|Behavioral|individual diet & physical activity counselor and website through Healthways at Hopkins|Phone and web-based weight loss intervention (via Healthways at Hopkins counselor and website) focused on increasing physical activity and adhering to a healthy diet. Participants will log diet, physical activity, and weight in web-hub. Counselors will have access to this information to direct participants to goals and achievements.
16088968|NCT02244411|Behavioral|self directed weight loss|Participants will be given information and links to CDC and American Cancer Society recommendations for healthy eating and physical activity.
16088969|NCT02244411|Behavioral|questionnaires|Participants will complete behavioral questionnaires as well as diet and physical activity assessments through CCSS-based study website as baseline, 12 and 24 months.
16088970|NCT02244411|Other|fasting blood draw, measurement of height, weight and waist circumference, and blood pressure|During three time periods, at baseline and at 12 and 24 months.
16088971|NCT02244398|Other|FP and HTC services|In this project, VHTs already providing family planning services are trained to offer HIV testing and counseling services (HTC).
16088972|NCT02244398|Other|FP services|VHTs in the control arm only provide family planning services
16088973|NCT02244385|Other|no intervention|
16088974|NCT02244372|Dietary Supplement|Cordyceps sinensis mycelium culture extract 0.76 g|
16088975|NCT02244372|Dietary Supplement|Cordyceps sinensis mycelium culture extract 1.15 g|
16088976|NCT02244372|Dietary Supplement|Placebo|
16088977|NCT02244359|Behavioral|Training|
16088978|NCT02244359|Behavioral|Usual care|
16088979|NCT02244346|Drug|Secotex®|
16088980|NCT02244333|Drug|ALNA®|
16088981|NCT02244320|Drug|Tamsulosin|
16088982|NCT02244307|Drug|alpha-adrenergic blocker|
16088983|NCT02244294|Drug|FLOMAX® capsules|
16088984|NCT02244294|Drug|Placebo capsules|
16088985|NCT02244281|Drug|tamsulosin hydrochloride|
16088986|NCT02244281|Drug|Placebo|
16088987|NCT02244268|Drug|ALNA®|
16088988|NCT02244255|Drug|FLOMAX® capsules|
16088989|NCT02244255|Drug|Ascending doses of HYTRIN® capsules|
16088990|NCT02244242|Drug|Tamsulosin hydrochloride|
16088991|NCT02244229|Drug|Tamsulosin|
16088992|NCT02244229|Drug|Finasteride|
16088993|NCT02244229|Drug|Placebo|
16088994|NCT02244216|Drug|Berotec® N 100 µg Metered-dose Inhaler|
16088995|NCT02244203|Drug|BI 60732|
16088996|NCT02244203|Drug|Placebo|
16088997|NCT02244190|Drug|Tipranavir|New oral solution (back up) formulation
16088998|NCT02244190|Drug|Tipranavir|
16088999|NCT02244190|Drug|Ritonavir|
16089000|NCT02244164|Drug|Incretinomimetics|
16089001|NCT02244164|Drug|DPP-4 inhibitors|
16089002|NCT02244151|Drug|Decapeptyl® diario|Decapeptyl® daily administration (Triptorelin acetate) and follicular puncture at 24, 30, 36 or 40 after administration.
16089003|NCT02244151|Drug|Decapeptyl® daily|Decapeptyl® daily OPU 36 hrs after GnRH administration
16089004|NCT02244138|Behavioral|Adolescent CDSS|computer decision support system (CDSS) for health care providers of adolescents in primary care
16089005|NCT02244125|Drug|PCD|"STUDY TREATMENT PHASE: All patients
~4x 28 days cycles of PCD
~[Pomalidomide: 4mg/day oral route on 21 days per cycle]
~[Cyclophosphamide: 300mg/day oral route on days 1, 8, 15, 22 per cycle]
~[Dexamethasone: 40mg/day oral route on days 1, 2, 3, 4 and 15, 16, 17, 18 per cycle]
~CONSOLIDATION PHASE: depends on previous IFM/DFCI 2009's arm:
~Arm A:
~Melphalan 200mg/m2 followed by Autologous Transplantation
~2x 28 days cycles of PCD, three months post transplantation
~Arm B:
~5x 28 days cycles of PCD
~[Pomalidomide: 4mg/day oral route on 21 days per cycle]
~[Cyclophosphamide: 300mg/day oral route on days 1, 8, 15, 22 per cycle]
~[Dexamethasone: 40mg/day oral route on days 1, 8, 15, 22 per cycle]
~MAINTENANCE PHASE: All patients
~- Until progression/relapse or discontinuation for any other reason
~[Pomalidomide: 4mg/day oral route on 21 days per cycle]
~[Dexamethasone: 20mg/day oral route on days 1, 8, 15, 22 per cycle]"
16089006|NCT02244125|Procedure|Autologous transplantation (ASCT)|"Arm A:
~•Melphalan 200mg/m2 followed by Autologous Transplantation"
16089007|NCT02244112|Drug|Oprozomib|Subjects will receive oprozomib 270 mg per dose in Part I and oprozomib 300 mg per dose in Part II.
16089008|NCT02244112|Drug|Midazolam|Subjects will receive a single oral dose of midazolam 2 mg in Period 1 and oral midazolam 2 mg per dose in Period 2.
16089131|NCT02243202|Drug|Matching Placebo to Phentermine|Placebo capsules look like phentermine but do not contain any active drug, taken once daily, orally for 26 weeks.
16089009|NCT02244099|Other|Controlled Substance|Patients will be identified using the reporting workbench in the EMR if they have been prescribed a controlled substance, carisoprodol, or tramadol at least 3 times in the last 6 months by one of the consenting resident physicians from Martha Morehouse General Internal Medicine Resident Continuity Clinic. Once identified, a comprehensive chart review for other important parameters based on best practice recommendations as described in the research protocol will be conducted in order to characterize the patient population for which the recommendations are being made to the physicians. Improvement in controlled substance, carisoprodol, and tramadol prescribing and adherence to the CSTA by the resident physicians will be tracked using a pre/post intervention comparison.
16089010|NCT02244086|Drug|bupivacaine|At the beginning of the work of effective labor maneuver randomly be allocated ( using sealed envelopes) and an outsider to the study prepared the dosage to bupivacaine 0.125% or 0.25% to be administered by epidural catheter for an anesthesiologist to disown the concentration employed. It is measured vital signs, and visual analogue scale dilatation in minutes 0,15,30,60 and 90 after being applied analgesia.
16089011|NCT02244073|Drug|Human insulin - Insulin administration to control blood glucose level.|On ICU admission, the glycated hemoglobin level (A1c) is measured and insulin IV is possibly administered using a web based nurse driven insulin infusion protocol (https://extranet.chu-lyon.fr/cpg) to maintain blood glucose level below 10 mmol/l. Glycated hemoglobin result triggers patient randomization. Thereafter, during ICU stay, blood glucose level is maintained either below 1.59 × A1c - 1.59 (mmol/l) (Individualized blood glucose target group), or bellow 10 mmol/l (Conventional blood glucose target group).
16089012|NCT02244060|Other|Priming effect from vignette|In the arm of DCV, the self-assessed vision (PSAV) is listed after the vignette questions; however, in the arm of ICV, the self-assessment of vision (SAV) is listed before the vignette questions. Priming effect from vignette will be estimated by comparing those two randomized variables (i.e., SAV and PSAV).
16089013|NCT02244047|Drug|Bifidobacterium breve|
16089014|NCT02244047|Drug|Placebo (for Bifidobacterium breve)|
16089015|NCT02244021|Drug|BRENTUXIMAB VEDOTIN|"Patients with FDG-PET positive after IGEV will be treated with brentuximab vedotin as followed: 1.8 mg/kg every 3 weeks as a 30-minute outpatient IV infusion for a total of 4 cycles of treatment
~Growth factors may be used at the discretion of investigators but are not routinely advised.
~Patients with FDG-PET negative after brentuximab vedotin treatment will be addressed to high dose chemotherapy followed by ASCT."
16089016|NCT02244008|Other|joint mobilization|The experimental group received joint mobilization (anteroposterior mobilization of the talus - Maitland grade III). During the mobilization cyclic movements were applied in an anteroposterior direction from the first tissue resistance barrier until the end of the accessory range of motion without any pain or discomfort. This mobilization maneuver was performed in 30-second duration sets with a 30-second interval between each set. The interventions lasted two weeks with three sessions each, completing six sessions.
16089017|NCT02244008|Other|manual contact|The placebo group received only manual contact. This maneuver was performed in 30-second duration sets with a 30-second interval between each set. The interventions lasted two weeks with three sessions each, completing six sessions.
16089018|NCT02243995|Other|Physical training|
16089019|NCT02243995|Behavioral|Physical training|
16089020|NCT02243982|Other|[F18]-FDDNP|radiopharmaceutical tracer, intravenous, single dose, of 360+/- 20 megabecquerel
16089021|NCT02243969|Dietary Supplement|Flaxseed oil|The flaxseed oil will be provided in vials containing 5 g of oil, and should be taken for twelve weeks during the experimental period twice a day
16089022|NCT02243969|Dietary Supplement|high oleic sunflower oil (HOSF)|The HOSF will be provided in vials containing 5 g of oil, and should be taken for twelve weeks during the experimental period twice a day
16089023|NCT02243956|Other|Flavanol rich food product|polyphenol rich test product
16089024|NCT02243943|Drug|Sugammadex|
16089025|NCT02243943|Drug|Neostigmine|
16089026|NCT02243930|Device|Disposable distal attachment|
16089027|NCT02243917|Drug|CB-5083|
16089028|NCT02243891|Procedure|Atrial fibrillation ablation|Percutaneous catheter ablation for Atrial fibrillation.
16089029|NCT02243891|Procedure|ROX Coupler insertion|The ROX Coupler is a CE-marked device designed to maintain an iliac arteriovenous fistula
16089030|NCT02243878|Radiation|Stereotactic radiotherapy (16 Gray or Sham)|Participants will be allocated in a 2:1 ratio to either 16 Gray SRT (IRay, Oraya, Newark,USA) delivered in a single session, or sham SRT.
16089031|NCT02243878|Drug|0.5 mg ranibizumab|Both arms will receive intravitreal injections of 0.5 mg ranibizumab at baseline, and then administered 'as required' (PRN) up to monthly, if predefined retreatment criteria are met.
16089032|NCT02243865|Device|Chordate System S200 + CT100 (active treatment)|
16089033|NCT02243865|Device|Chordate System S200 + CT100 (placebo treatment)|
16089034|NCT02243852|Drug|Growth Hormone Replacement Therapy|An observational study of patients who are commencing GH replacement as part of their routine NHS clinical care to assess changes in serum FGF21 concentration and determine how these relate to changes in body composition.
16089035|NCT02243839|Drug|Thrombolytic Therapy|Thrombolytic therapy is performed to the patients with obstructive prosthetic valve thrombosis
16089036|NCT02243839|Procedure|Surgery|Redo valve surgery is performed for obstructive valve thrombosis
16089037|NCT02243826|Drug|50:50 mixture of nitrous oxide/oxygen|
16089038|NCT02243813|Drug|Psilocybin|Participants will receive 20 mg/70 kg of psilocybin in the first session and will receive either 20 or 30 mg/70 kg in the second session.
16089039|NCT02243800|Other|cholecalciferol versus placebo|
16089040|NCT02243787|Drug|COVA322|
16089041|NCT02243787|Other|Placebo|
16089042|NCT02243774|Behavioral|Core letter signed by Surgeon General|The core letter provides information about influenza and the risks associated with it, incorporating a number of behavioral insights. All four letters evaluated in this study will contain the same tops and bodies that are included in the core letter, but the signature and P.S. tag region will differ among the various intervention groups. In this intervention, the core letter is signed by and includes a picture of the Surgeon General. The letter ends after the signature line and the space beneath the signature line is left blank where a P.S. tag region could be appended.
16089132|NCT02243189|Drug|JNJ-43260295|A single nasal dose of JNJ-43260295, 6400 microgram, will be given.
16089252|NCT02242305|Drug|Hyoscine Butylbromide - Tablet|
16089043|NCT02243774|Behavioral|Core letter signed by the Director of the National Vaccine Program|The core letter is signed by and includes a picture of the Director of the National Vaccine Program. The letter ends after the signature line and the space beneath the signature line is left blank where a P.S. tag region could be appended.
16089044|NCT02243774|Behavioral|Core letter signed by Surgeon General + implementation prompt|The core letter is signed by and includes a picture of the Surgeon General. Below the signature line of the core letter, an implementation intention prompt is provided in the P.S. tag region that invites the recipient to write in the day of week, month, day, and time at which he or she plans to get vaccinated.
16089045|NCT02243774|Behavioral|Core letter signed by SG + enhanced implementation prompt|"The core letter is signed by and includes a picture of the Surgeon General (SG). Below the signature line of the core letter, an enhanced implementation intention prompt is provided in the P.S. tag region that prompts recipients to decide now - by checking one of two boxes - indicating they will or will not get vaccinated. The options use language that highlights the losses incumbent in refusing to vaccinate. In addition, an implementation intention prompt is embedded into the checkbox for indicating a choice to be vaccinated."
16089046|NCT02243761|Other|DBT Based Skills Groups for Families|12 weeks of Dialectical Behaviour Therapy skills training group for families (90-minute once-weekly sessions)
16089047|NCT02243748|Other|Palliative Therapy|Receive individualized palliative care
16089048|NCT02243748|Other|quality-of-life assessment|Ancillary studies
16089049|NCT02243748|Other|questionnaire administration|Ancillary studies
16089050|NCT02243735|Drug|Ferrous fumarate|Patients randomized to standard care with ferrous fumarate will receive three tablets of 200 mg daily from randomisation until day before surgery
16089051|NCT02243735|Drug|ferric(III)carboxymaltose|Patients randomized to intravenous iron (ferric(III)carboxymaltose) will be dosed according to Summary of Product Characteristics (SPC) depending on body weight and Hb value and administered in one or two infusions with one week in between. A maximum dose of 1000mg or 15mg/kg per week will be administered
16089052|NCT02243709|Drug|Mifepristone 600-mg/day or placebo for a week|600-mg of mifepristone for a week, compared to placebo for a week, in a stress-induced condition triggered by a single dose of 32.4 mg of yohimbine
16089053|NCT02243683|Drug|AX-024.HCl|
16089054|NCT02243683|Other|Placebo|
16089055|NCT02243670|Device|AiCure monitoring and intervention|Participants will use the AiCure app to monitor ingestion of all prescribed doses of Zubsolv®. If a participant misses a dose, takes an incorrect dose, or their data are flagged for suspicious activity, they will be contacted by research staff or the AiCure study team through automated SMS text or by phone.
16089056|NCT02243657|Drug|ASP3652|oral
16089057|NCT02243657|Drug|Placebo|oral
16089058|NCT02243644|Drug|7 days of albendazole 15 mg/kg/day|group A will receive 7 days of oral albendazole 15 mg/kg/day
16089059|NCT02243644|Drug|28 days of albendazole 15 mg/kg/day|group B will receive 28 days of oral albendazole 15 mg/kg/day
16089060|NCT02243631|Drug|Probenecid|Treatment
16089061|NCT02243618|Drug|Polaprezinc|Administration of pantoprazole 40 mg q.d. and polaprezinc 75 mg b.i.d. for 4 weeks after the ESD.
16089062|NCT02243618|Drug|Rebamipide|Administration of pantoprazole 40 mg q.d. and rebamipide 100 mg t.i.d. for 4 weeks after the ESD.
16089063|NCT02243605|Drug|Cabozantinib S-malate|Given PO
16089064|NCT02243605|Other|Laboratory Biomarker Analysis|Correlative studies
16089065|NCT02243592|Other|Laboratory Biomarker Analysis|Undergo sequencing and SNP analysis
16089066|NCT02243579|Other|Laboratory Biomarker Analysis|Correlative studies
16089067|NCT02243579|Biological|Pembrolizumab|Given IV
16089068|NCT02243566|Drug|MicardisPlus®|
16089069|NCT02243553|Drug|Tipranavir capsule|
16089070|NCT02243553|Drug|Tipranavir solution|
16089071|NCT02243553|Drug|Ritonavir capsule|
16089072|NCT02243553|Drug|Caffeine|
16089073|NCT02243553|Drug|Warfarin sodium|
16089074|NCT02243553|Drug|Vitamin K|
16089075|NCT02243553|Drug|Omeprazole|
16089076|NCT02243553|Drug|Dextromethorphan hydrobromide|
16089077|NCT02243553|Drug|Midazolam injection|
16089078|NCT02243553|Drug|Midazolam oral solution|
16089079|NCT02243553|Drug|Digoxin tablet|
16089080|NCT02243553|Drug|Digoxin injection|
16089081|NCT02243527|Other|Inspiratory Muscle Training|6-weeks of inspiratory muscle training
16089082|NCT02243527|Other|Sham Inspiratory Muscle Training|A sham training procedure that is meant to elicit no physiologic changes
16089083|NCT02243501|Behavioral|Intervention Group|The BNBD intervention for caregivers of children 1 to 10 years with insomnia is a self-guided program delivered online. The intervention is conceptually consistent across age groups. Interactive and personalized content and evidence-based strategies are incorporated: sleep education, positive routines, faded bedtime with response cost, sleep restriction, extinction/graduated extinction, stimulus fading, and scheduled awakenings. BNBD includes five sessions available sequentially: Sleep Information; Healthy Sleep Practices; Settling to Sleep; Going Back to Sleep; Looking Back and Ahead. The completion time of the intervention will range from 5-10 weeks.
16089084|NCT02243488|Device|Irise Easy Pad & Menstrual Health Education|Reusable manufactured sanitary pad produced by Irise Uganda Limited and education sessions provided by qualified menstrual health educators
16089085|NCT02243462|Device|Forced Air Warmer|"A forced air warmer device will be used to pre-warm patients for 10 minutes in holding bay before surgery. Air warming device is an electrically powered control unit, hose, and inflatable blanket. The control unit has an air filter and heater, which warms air entrained from the environment. The hose connects to a blanket."
16089086|NCT02243462|Other|No pre-op warming|No forced air warming of the patient prior to being taken in for surgery
16089133|NCT02243189|Drug|Placebo|A single nasal dose of placebo matching to JNJ-43260295 will be given.
16089134|NCT02243189|Drug|Nasal Allergen Challenge|Participants will be challenged by the nasal route with an appropriate allergen based on skin test reactivity.
16089135|NCT02243176|Drug|Saxagliptin|The dose of saxaglitpin will be 5mg oral qd.
16089136|NCT02243176|Drug|Acarbose|Patients who take acarbose will begin with 50mg tid for 7 days then be titrated to 100mg tid till the end of the study. A call visit (V5) will be performed at Week 1 for adverse event and reminding patients the dose titration of acrabose.
16089087|NCT02243449|Procedure|Once daily screening|In the 'once daily screening arm', RTs will screen invasively ventilated patients between approximately 06:00 - 08:00 hours daily. To pass the 'readiness to wean screen' and undergo an SBT, specific criteria must be met. The initial SBT will be 30-120 minutes in duration and may be conducted with any one of the following techniques: T-piece, continuous positive airway pressure (CPAP) less than or equal to 5 cm H2O or PS less than or equal to 8 cm H2O with PEEP less than or equal to 5 - 10 cm H2O. Higher levels of PEEP (8-10 cm H2O) will be permitted (and recorded) to allow for clinician discretion in conducting SBTs in specific patients (e.g., obese, chronic obstructive pulmonary disease) and use of different humidification strategies. Each centre will be asked to choose one technique to be used for patients enrolled at their centre.
16089088|NCT02243449|Procedure|At least twice daily screening|In the 'at least twice daily' screening arm patients will be screened at a minimum between approximately 6:00-8:00 hours and 13:00-15:00 hours daily. To pass the 'readiness to wean screen' and undergo an SBT, specific criteria must be met. The initial SBT will be conducted in the same manner as in the once daily screening arm. The subsequent SBTs will be 30 -120 minutes in duration and may be conducted with any one of the following techniques: T-piece, CPAP < to 5 cm H2 O or PS < 8 cm H2 O with PEEP < 5 - 10 cm H2O. Higher levels of PEEP (8-10 cm H2O) will be permitted (and recorded) to allow for clinician discretion in conducting SBTs in specific patients (e.g., obese, chronic obstructive pulmonary disease) and with the use of different humidification strategies. Each centre will be asked to choose one technique for all patients enrolled at their centre.
16089089|NCT02243436|Drug|Brentuximab Vedotin|Brentuximab Vedotin, 0.9mg/kg, 1.2mg/kg, 1.8mg/kg, day 1
16089090|NCT02243436|Drug|Etoposide|Intravenose use, 40mg/m2/day, on days 1 to 4
16089091|NCT02243436|Drug|Soludomerin|Intravenous use, 250mg/day, on days 1 to 4
16089092|NCT02243436|Drug|Cisplatin|Intravenous use, 25mg/m2/day, on days 1 to 4
16089093|NCT02243436|Drug|Ara C|Intravenous use, 2g/m2, day 5
16089094|NCT02243423|Procedure|SUPINE|"Patients in the SUPINE group will receive spinal anesthesia for cesarean section in the sitting position, after which they will lay supine horizontal on the surgical table.
~A phenylephrine intravenous infusion will be titrated according to a set protocol, to maintain the systolic blood pressure at baseline."
16089095|NCT02243423|Procedure|TILT|"Patients will receive spinal anesthesia for cesarean section in the sitting position, after which they will lay on the surgical table, which will be tilted to the left by 15°.
~A phenylephrine intravenous infusion will be titrated according to a set protocol to maintain the systolic blood pressure at baseline."
16089096|NCT02243384|Procedure|Laparoscopic Hepatectomy|A total of 110 patients with early HCC with nodular diameters of less than 3 cm and up to three nodules were randomly divided into LH (n=55) and RFA groups (n=55). Outcomes were carefully monitored and evaluated during the 3-year follow-up period
16089097|NCT02243384|Procedure|Radiofrequency Ablation|A total of 110 patients with early HCC with nodular diameters of less than 3 cm and up to three nodules were randomly divided into LH (n=55) and RFA groups (n=55). Outcomes were carefully monitored and evaluated during the 3-year follow-up period
16089098|NCT02243371|Biological|CRS-207|1 × 10^9 CFU administered IV on Day 2 of Cycles 3-6
16089099|NCT02243371|Biological|CRS-207|1 × 10^9 CFU administered IV on Day 1 of Cycles 3-6
16089100|NCT02243371|Drug|nivolumab|3 mg/kg administered IV on Day 1 of Cycles 1-6
16089101|NCT02243371|Biological|GVAX|5x10^8 cells administered in 6 intradermal injections on Day 2 of Cycles 1 and 2
16089102|NCT02243371|Drug|CY|200 mg/m^2 administered IV on Day 1 of Cycles 1 and 2
16089103|NCT02243358|Drug|Folfox6|
16089104|NCT02243358|Drug|Gemcitabine|
16089105|NCT02243358|Radiation|Radiation Therapy|
16089106|NCT02243358|Procedure|Pancreaticoduodenectomy with retroperitoneal lymphadenectomy|
16089107|NCT02243332|Device|KneeStim mobile rehabilitation assistance device|KneeStim is a neuromuscular electrical stimulation (NMES) device that integrates motion-tracking hardware like three-axis accelerometers and a real-time operating system to enable quadriceps muscle stimulation in time with user gait. It is a completely non-invasive device that looks like a light brace and fastens to the user's quadriceps and gastrocnemius muscles. The end goal of this device is to assist with muscle re-strengthening and re-education during a user's everyday activities.
16089108|NCT02243319|Drug|HGP1201|
16089109|NCT02243319|Drug|HGP0904|
16089110|NCT02243319|Drug|HGP0904 and HGP1201 co-administraion|
16089111|NCT02243306|Drug|GSK1278863|Round, biconvex, white film coated tablet containing 5 mg GSK1278863.
16089112|NCT02243293|Drug|ABT-493|Tablet
16089113|NCT02243293|Drug|ABT-530|Tablet
16089114|NCT02243293|Drug|ribavirin (RBV)|Tablet
16089115|NCT02243293|Drug|ABT-493/ABT-530|Tablet; ABT-493 co-formulated ABT-530
16089116|NCT02243280|Drug|ABT-493|Tablet
16089117|NCT02243280|Drug|ABT-530|Tablet
16089118|NCT02243267|Other|sample collection|
16089119|NCT02243254|Drug|high dose remifentanil|high dose remifentanil
16089120|NCT02243254|Drug|Ibuprofen|intravenous ibuprofen
16089121|NCT02243254|Drug|low dose remifentanil|low dose remifentanil
16089122|NCT02243241|Drug|HYD|Hydrocodone bitartrate 80 mg (day 9), 120 mg (day 12), 160 mg [(1) 40 mg tablet + (1) 120 mg tablet] (day 15) extended-release tablets administered orally every 24 hours.
16089123|NCT02243241|Drug|Moxifloxacin|Moxifloxacin 400 mg tablets administered orally on the morning of day 9, day 12, and day 15 only.
16089124|NCT02243241|Drug|Placebo for HYD|Placebo to match HYD tablets administered orally every 24 hours.
16089125|NCT02243241|Drug|Placebo for moxifloxacin|Placebo to match moxifloxacin tablets administered orally on the mornings of day 9, day 12, and day 15 only.
16089126|NCT02243228|Drug|GM-CSF|
16089127|NCT02243215|Other|Access to a portable trainer for laparoscopic skills|Participants will have a portable trainer available to allow training at their convenience, and will be able practice on-site at Center of Clinical Education and at their local hospital.
16089128|NCT02243202|Drug|Canagliflozin|300 mg capsule, taken once daily, orally for 26 weeks.
16089129|NCT02243202|Drug|Phentermine|15 mg capsule, taken once daily, orally for 26 weeks.
16089130|NCT02243202|Drug|Matching Placebo to Canagliflozin|Placebo capsules look like canagliflozin but do not contain any active drug, taken once daily, orally for 26 weeks.
16089245|NCT02242357|Drug|Micardis® Plus|
16089137|NCT02243163|Behavioral|Yoga exercise|Subjects will receive regular 90-minutes yoga classes twice a week for 3 months.
16089138|NCT02243150|Drug|G1T28-1 (CDK 4/6 Inhibitor)|
16089139|NCT02243150|Drug|Placebo|
16089140|NCT02243137|Drug|acetylsalicylic acid|Administration: one dose of Acetylsalicylic Acid (300mg)
16089141|NCT02243137|Drug|prasugrel|Administration: one loading dose (60mg)
16089142|NCT02243137|Drug|lysine acetylsalicylate|Administration: one dose (450mg iv)
16089143|NCT02243124|Drug|cenersen|cenersen is a phosphorothioate antisense oligonucleotide that down-regulates the production of both wild-type and mutant p53, and has a RNase H-dependent mechanism of action
16089144|NCT02243124|Drug|Dexamethasone|Optionally, Dexamethasone 20 mg po weekly can be added after week 16 if stable disease but no HI is observed.
16089145|NCT02243111|Radiation|Doppler ultrasound|Detecting Doppler signals from the lungs on the right chest wall
16089146|NCT02243098|Drug|semaglutide|Administered as a subcutaneous injection (s.c., under the skin). Initiated with weekly semaglutide dosing of 0.25 mg in the first 4 weeks, 0.5 mg the next 4 weeks, and 1.0 mg in the third 4 week period.
16089147|NCT02243098|Drug|digoxin|Oral administration. Digoxin will be given as 2 single doses of 0.5 mg.
16089148|NCT02243098|Drug|atorvastatin|Oral administration. Atorvastatin will be given as 2 single doses of 40 mg.
16089149|NCT02243072|Behavioral|Fit Families plus Standard Medical Care|Adolescents will receive the Fit Families plus Standard Medical Care which consists of twice weekly home-based, family psychotherapy from a CHW for 6 months
16089150|NCT02243059|Drug|Gadofosveset trisodium (Ablavar™ )|
16089151|NCT02243059|Device|MRI|
16089152|NCT02243046|Drug|Control toothpaste|1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.
16089153|NCT02243046|Drug|Experimental toothpaste|1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.
16089154|NCT02243046|Drug|Active Comparator|1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.
16089155|NCT02243033|Device|MR-guided laser focal therapy|Placement of laser applicator under MRI guidance and real-time MR thermal imaging of tissue necrosis.
16089156|NCT02243020|Device|Vagus Nerve Stimulation (VNS)|
16089157|NCT02243007|Drug|FOLFIRINOX|
16089158|NCT02243007|Drug|Gemcitabine/nab-Paclitaxel|
16089159|NCT02243007|Radiation|Radiation therapy|
16089160|NCT02243007|Drug|Capecitabine|
16089161|NCT02242994|Device|Dynavox Maestro|Receives commercially available communication device Dynavox Maestro to test speed and quality of communication.
16089162|NCT02242994|Device|Experimental App|Participant receives experimental app to test speed and error rate of communication.
16089163|NCT02242981|Drug|LY2623091|Administered orally
16089164|NCT02242955|Drug|Diazepam|40 mg per day.
16089165|NCT02242942|Drug|Chlorambucil|Chlorambucil 0.5 milligrams per kilogram (mg/kg) orally at Day 1 and Day 15 at of each 28 day cycle for 12 cycles.
16089166|NCT02242942|Drug|Venetoclax|Venetoclax, oral tablet: 20 mg daily during Cycle 1, Day 22-28; 50 mg daily during Cycle 2, Day 1-7; 100 mg daily during Cycle 2, Day 8-14; 200 mg daily during Cycle 2, Day 15-21; 400 mg daily during Cycle 2, Day 22-28 and on Day 1-28 for all subsequent cycles until the end of Cycle 12.
16089167|NCT02242942|Drug|Obinutuzumab|Obinutuzumab, IV infusion: 100 mg or 1000 mg, depending on splitting rules, at Cycle 1, Day 1 (if 100 mg was received on Day 1, 900 mg will be administered on Cycle 1, Day 2); 1000 mg at Cycle 1, Day 8 and Day 15; 1000 mg at Day 1 for all subsequent cycles until the end of Cycle 6
16089168|NCT02242929|Drug|Imiquimod 5% cream with prior curettage|
16089169|NCT02242929|Procedure|Standard surgical excision|
16089170|NCT02242916|Radiation|Photon therapy versus proton therapy|
16089171|NCT02242916|Radiation|Photon therapy versus C-ion therapy|
16089172|NCT02242903|Drug|LY3079514|Administered SC
16089173|NCT02242903|Drug|LY3079514|Administered IV
16089174|NCT02242903|Drug|Placebo|Administered SC
16089175|NCT02242903|Drug|Placebo|Administered IV
16089176|NCT02242890|Behavioral|Contraception Information Packet|The intervention will consist of brief education about IUC and development of interpersonal skills, including how to initiate conversations about reproductive health issues in social settings and debunking common IUC myths.
16089177|NCT02242877|Drug|Telmisartan|
16089178|NCT02242877|Drug|Telmisartan combined with hydrochlorothiazide|
16089179|NCT02242864|Drug|Micardis®|
16089180|NCT02242864|Drug|MicardisPlus®|
16089181|NCT02242851|Drug|Telmisartan|
16089182|NCT02242838|Drug|Telmisartan|
16089183|NCT02242825|Drug|Micardis®|
16089184|NCT02242825|Drug|MicardisPlus®|
16089185|NCT02242812|Drug|Telmisartan|
16089186|NCT02242812|Drug|Metoprolol succinate|
16089187|NCT02242812|Drug|Placebo|
16089188|NCT02242799|Drug|Dolutegravir 50mg od|Dolutegravir 50mg once daily will be given either alone or in combination, as specified
16089189|NCT02242799|Drug|Artemether-lumefantrine combination|Artemether-lumefantrine combination will be given both alone and in combination with Dolutegravir 50mg od in order to assess changes in PK
16089190|NCT02242799|Drug|Artesunate-amodiaquine|Artesunate-amodiaquine will be given alone or in combination with Dolutegravir 50mg od (in a parallel study design) in order to assess the potential interaction causing changes in PK parameters
16089191|NCT02242786|Radiation|External beam radiation therapy|
16089192|NCT02242773|Device|Multi-Parametric MRI|Multi-Parametric MRI
16089193|NCT02242773|Device|MRI-Guided Biopsy|MRI-Guided Biopsy
16089194|NCT02242760|Drug|SB204 2%|Applied topically twice daily
16089195|NCT02242760|Drug|SB204 4%|Applied topically daily
16089196|NCT02242760|Drug|Vehicle Gel|Applied topically twice and once daily
16089246|NCT02242344|Drug|Telmisartan|
16089197|NCT02242747|Drug|ingenol mebutate|an application a day for three consecutive days in a pre-determined area
16089198|NCT02242747|Drug|5% 5-FU|two applications a day for four weeks in a pre-determined area
16089199|NCT02242734|Drug|20 mg HC-ER|1-72 hours
16089200|NCT02242734|Drug|20 mg HC-ER|1-72 hours
16089201|NCT02242734|Drug|20 mg HC-ER|1-72 hours
16089202|NCT02242708|Behavioral|Alternative nostril breathing|The experimental groups will do alternative nostril breathing twice a week (20 minutes/time) for 3 months.
16089203|NCT02242695|Drug|Fluomizin vaginal tablets|One vaginal tablet for 6 days and 1 placebo tablet on day 7
16089204|NCT02242695|Drug|Canesten vaginal tablets|one vaginal tablet for 7 days
16089205|NCT02242682|Other|Child passenger safety video|
16089206|NCT02242656|Drug|Opium Tincture USP Deodorized|Treatment A - 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized) QID oral drops, followed by Treatment B - 0.6 mL, MP-101, 1/12 dilution, (0.833 mg/mL, OT), USP (Deodorized) QID oral drops, followed by Treatment C - 0.6 mL, MP-101 (10 mg/mL Opium Tincture with reduced uncharacterized material) QID oral drops
16089207|NCT02242656|Drug|Opium Tincture USP Deodorized|Treatment B - 0.6 mL, MP-101, 1/12 dilution, (0.833 mg/mL, OT), USP (Deodorized) QID oral drops, followed by Treatment A - 0.6 mL, MP-101 (10 mg/mL, Opium Tincture (OT)), USP (Deodorized) QID oral drops, followed by Treatment C - 0.6 mL, MP-101 (10 mg/mL Opium Tincture with reduced uncharacterized material) QID oral drops
16089208|NCT02242643|Biological|FluLaval™ Quadrivalent|1 or 2 doses administered intramusculary (IM) in deltoid region of non-dominant arm (for subjects ≥12 months of age) or anterolateral region of left thigh (for subjects <12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively
16089209|NCT02242643|Biological|Fluzone® Quadrivalent|1 or 2 doses administered IM in deltoid region of non-dominant arm (for subjects ≥12 months of age) or anterolateral region of left thigh (for subjects <12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively
16089210|NCT02242630|Drug|Methylprednisolone, 20 mg|Compared with intrabursal triamcinolone
16089211|NCT02242630|Drug|Methylprednisolone, 40 mg|Compared with intrabursal triamcinolone
16089212|NCT02242630|Drug|Triamcinolone, 20 mg|Compared with methylprednisolone
16089213|NCT02242630|Drug|Triamcinolone, 40 mg|Compared with methylprednisolone
16089214|NCT02242617|Device|Positive Airway Pressure (PAP)|Continuous or auto-adjusting positive airway pressure (i.e. CPAP, APAP, and described here as PAP): a device which consists of a face mask attached to a plastic tube and a machine that blows compressed air through a patient's airway during sleep to keep the airway open
16089215|NCT02242617|Device|Mandibular Advancement Splints (MAS)|Mandibular advancement splints (MAS): dental splints used to keep the mandible in an advanced position opening the upper airway during sleep
16089216|NCT02242604|Other|Multidimensional Geriatric Assessment (MGA)|"The MGA contains the following tests:
~Barthel Katz Index (activity of daily living, ADL)
~Mini Mental State Test (MMST)
~DemTec (dementia detection test)
~Clock Test
~Geriatric Depression Scale (GDS)
~Tinetti Test
~TUG (timed up-and-go Test)
~Esslinger Transfer Scale (ETS)
~Handgrip Test
~Mini Nutritional Assessment (MNA)"
16089217|NCT02242591|Drug|Ropivacaine 7,5 mg/ml|
16089218|NCT02242591|Drug|Saline|
16089219|NCT02242578|Device|1 Hz rTMS|About 1,000 stimulation pulses over 20 min
16089220|NCT02242578|Device|10 Hz rTMS|About 1,000 stimulation pulses over 20 min
16089221|NCT02242565|Device|ShangRing|ShangRing device for male circumcision
16089222|NCT02242539|Behavioral|Height measurement poster|Each household is provided with a poster which study personnel help to hang on the wall. The poster clearly indicates height-for-age benchmarks and stunting cut-offs for study-age children. Parents are provided training on how to measure their children at regular intervals, and interpret height readings to determine whether their child is developing normally or is stunted.
16089223|NCT02242539|Behavioral|Community-based monitoring|"Once every three months, villages are visited by study staff who measure children's heights and weights, and parents are informed if their children are below the reference measures established by the World Health Organization. If a child's weight is such that the child is classified as severely malnourished, the child is referred to the nearest health center for treatment. If the child is stunted (height-for-age z-score more than 2 standard deviations below the reference median), we provide parents with a supply of Yummy Soy powder, a fortified soy and maize mix popular among parents and widely available in local super markets. Parents are instructed to give one or two tea spoons of the mix to the child each day."
16089224|NCT02242526|Device|Parietex™ Composite Hiatal Mesh, North Haven, CT|Parietex™ Composite Hiatal Mesh (North Haven, CT) designed for hiatal hernia repair.
16089225|NCT02242526|Device|Biodesign™ Surgisis® Graft, Cook Medical, Bloomington|Biodesign™ Surgisis® Graft (Cook Medical, Bloomington) designed for hiatal hernia repair.
16089226|NCT02242513|Device|Pulsed radiofrequency (PRF)|Pulsed radiofrequency (PRF) treatment, a relative novel pain intervention at recent decade, was found to be able to alleviate pain by delivering an electrical field and heat bursts at a temperature less than 42°C to neural tissue in the absence of neural injury.
16089227|NCT02242513|Drug|Xylocaine|
16089228|NCT02242500|Procedure|Coronally Advanced Flap|
16089229|NCT02242500|Device|Mucograft|
16089230|NCT02242487|Drug|CVT-301|
16089231|NCT02242474|Drug|Anti-TNF suspended perioperatively|
16089232|NCT02242474|Drug|Anti-TNFα continued perioperatively|
16089233|NCT02242461|Drug|Rhodiola placebo capsules|Corn starch
16089234|NCT02242461|Drug|Rhodiola Crenulata|Rhodiola Crenulata
16089235|NCT02242435|Biological|Ampion <5 kDa ultrafiltrate of 5% human serum albumin|4 mL intra-articular injection of Ampion
16089236|NCT02242435|Biological|Placebo|Saline
16089237|NCT02242409|Drug|Gemcitabine and Abraxane|Gemcitabine 1000 mg/m2 followed by abraxane 125 mg/m2 administered intravenously on days 1, 8, and 15 every 28 days
16089238|NCT02242396|Drug|Telmisartan|
16089239|NCT02242396|Drug|Telmisartan hydrochlorothiazide|
16089240|NCT02242383|Drug|Telmisartan|
16089241|NCT02242383|Drug|Telmisartan in combination with hydrochlorothiazide|
16089242|NCT02242370|Drug|Low dose of telmisartan|
16089243|NCT02242370|Drug|High dose of telmisartan|
16089244|NCT02242357|Drug|Micardis®|
16089253|NCT02242305|Drug|Hyoscine Butylbromide - Capsule|
16089254|NCT02242305|Drug|Placebo|
16089255|NCT02242292|Drug|Hyoscine butylbromide|
16089256|NCT02242292|Drug|Placebo|
16089257|NCT02242279|Drug|BEA 2180 BR|
16089258|NCT02242279|Drug|Tiotropium|
16089259|NCT02242279|Drug|Placebo|
16089260|NCT02242266|Drug|Tiotropium low dose|inhalation powder, hard PE capsule
16089261|NCT02242266|Drug|Tiotropium medium dose|inhalation powder, hard PE capsule
16089262|NCT02242266|Drug|Spiriva® HandiHaler® high dose|Tiotropium inhalation powder, hard gelatine capsule
16089263|NCT02242266|Drug|Placebo via the blue HandiHaler®|oral inhalation via the blue HandiHaler®
16089264|NCT02242266|Drug|Placebo via the grey HandiHaler®|oral inhalation via the grey HandiHaler®
16089265|NCT02242253|Drug|Tiotropium|administered via HandiHaler®
16089266|NCT02242253|Drug|Salmeterol|administered via metered dose inhaler (MDI)
16089267|NCT02242253|Drug|Placebo-MDI|
16089268|NCT02242253|Drug|Placebo HandiHaler®|
16089269|NCT02242240|Drug|Formoterol twice daily|
16089270|NCT02242240|Drug|Formoterol once daily|
16089271|NCT02242240|Drug|Tiotropium once daily|
16089272|NCT02242240|Drug|Placebo|
16089273|NCT02242227|Drug|Salmeterol xinafoate|
16089274|NCT02242227|Drug|Serevent® Diskus®|
16089275|NCT02242227|Drug|Placebo (HandiHaler®)|
16089276|NCT02242227|Drug|Placebo (Diskus®)|
16089277|NCT02242214|Drug|Misoprostol|
16089278|NCT02242201|Drug|PNB Bupivacaine|Infusion
16089279|NCT02242201|Drug|PAI Ropivacaine|Injection
16089280|NCT02242201|Drug|PAI liposomal bupivacaine|Injection
16089281|NCT02242201|Drug|Epinephrine|Injection, weight-based dosage of 100 mcg - 300 mcg
16089282|NCT02242201|Drug|Ketorolac|Injection, 30 mg
16089283|NCT02242188|Drug|Iron|"Ferric pyrophosphate (powder preparation in sachets: Actiferol, SunActive Fe, Sequoia, Poland) in a single daily dose. Three doses will be used: 7 mg for infants up to 7 kg of body weight, 10 mg for infants from 7 to 10 kg of body weight, and 15 mg for those exceeding the weight of 10 kg. Caregivers will be instructed to administer the daily dose at the same time of a day, after mixing the content of the sachet with a little amount of breastmilk or milk formula.
~The intervention will last from 4 months to 9 months of age."
16089284|NCT02242188|Dietary Supplement|Placebo|Maltodextrin (packed in identical sachets as active products)
16089285|NCT02242175|Device|Glucose breath test (hydrogen breath test)|Glucose breath test (hydrogen breath test) is the current gold standard for diagnosis of irritable bowel syndrome. Glucose is a sugar that will be broken down by bacteria if present in the small bowel with hydrogen or methane gas as a by-product. The breath sample will be analyzed for hydrogen or methane content to determine if you are able to properly break down the lactose, fructose or sucrose, or if you have bacterial overgrowth.
16089286|NCT02242162|Procedure|phrenic nerves magnetic stimulations|
16089287|NCT02242149|Drug|Diacerein|All subjects will be given diacerein with a starting dose of 50 mg in one tablet once daily for 2 weeks. After 2 weeks, they will be given diacerein 50 mg in one tablet twice daily for the duration of sudy.
16089288|NCT02242149|Drug|Placebo|Sugar pill manufactured to mimic Diacerein
16089289|NCT02242136|Behavioral|FORNET|
16089290|NCT02242110|Behavioral|ERRT-Bipolar Disorder|The nightmare treatment, called Exposure, Relaxation, and Rescripting Therapy for Bipolar disorder, is a weekly 5-session treatment aimed at reducing chronic trauma nightmares and sleep disturbances in adults diagnosed with bipolar disorder.
16089291|NCT02242097|Drug|ibrutinib|Given PO
16089292|NCT02242097|Other|laboratory biomarker analysis|Correlative studies
16089293|NCT02242084|Drug|Intravenuse Alteplase|
16089294|NCT02242071|Biological|Stem Cell|intrathecal autologous bone marrow mononuclear cell transplantation
16089295|NCT02242058|Other|Quantitative sensory testing|
16089296|NCT02242045|Drug|Idelalisib|150 mg tablet(s) administered orally twice daily
16089297|NCT02242032|Drug|P-321 Ophthalmic Solution|
16089298|NCT02242032|Drug|P-321 Ophthalmic Solution placebo|Placebo to match P-321 Ophthalmic Solution
16089299|NCT02242019|Device|Erchonia LUNULA|The Erchonia LUNULA is administered to the infected toes for 12 minutes per treatment for 4 treatments, each treatment one week apart.
16089300|NCT02242006|Other|serial serum sampling for quantification of drug concentration|
16089301|NCT02241980|Other|Patient survey|
16089302|NCT02241980|Other|Physician survey|
16089303|NCT02241967|Device|4 Real sessions of Transcranial Direct Current Stimulation|Stimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp.
16089304|NCT02241967|Device|2 Real Sessions of Transcranial Direct Current Stimulation|Stimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp. 2 real sessions of tDCS and 2 sham.
16089305|NCT02241967|Device|1 Real Session of Transcranial Direct Current Stimulation|Stimulation of brain areas associated with pain perception using low amplitude direct current of 2mA delivered by electrodes attached to the scalp. 1 real sessions of tDCS and 3 sham.
16089306|NCT02241967|Device|Sham Transcranial Direct Current Stimulation|Four sessions of sham tDCS; control intervention.
16089307|NCT02241954|Device|Synthes VEPTR (Vertical Expandable Prosthetic Titanium Rib)|
16089308|NCT02241941|Drug|Daptomycin|
16089309|NCT02241928|Biological|Stem Cell|Intrathecal Autologous bone marrow mononuclear cell transplantation
16089310|NCT02241915|Procedure|Open Colorectal Surgery|
16089311|NCT02241915|Procedure|Laparoscopic Surgery|
16089312|NCT02241889|Device|Insulin pump therapy|Subject's own insulin pump will be used to manage blood glucose.
16089313|NCT02241889|Device|Closed-loop Artificial Pancreas Controller|Closed-loop Artificial Pancreas Controller includes insulin and glucagon delivery algorithm implemented on a smart phone, utilizing sensor glucose values from a Dexcom G4 sensor and sending delivery commands to two Tandem t:slim insulin pumps, one filled with insulin and one with glucagon.
16089314|NCT02241876|Drug|N-acetylcysteine|
16089404|NCT02241057|Other|Temperature Probe|
16089315|NCT02241863|Behavioral|Multifaceted intervention|Supportive intervention: care giver, health care providers, and patient's family members (including disease knowledge, treatment t of the disease, medication problems or adverse effects, the importance of medication adherence, supervision taking medications by the patients as prescribed). patient education: about the disease and treatment, consuming regularly the pills motivational intervening, self-monitoring planning. Patients will attend in five motivational interviewing sessions regularly to facilitating and engaging intrinsic motivation within the patients in order to change medication adherence behavior.
16089316|NCT02241863|Behavioral|Routine counseling|
16089317|NCT02241850|Other|High intensity training|9 weeks of supervised high intensity training
16089318|NCT02241824|Device|In-elastic lumbar brace|
16089319|NCT02241824|Device|Elastic abdominal binder|
16089320|NCT02241811|Drug|3% Sodium Pentaborate Pentahydrate|For the interventional group after wound dressing we applied hydrogel with 3% Sodium pentaborate pentahydrate everyday for two months. The same doctor observed and took photo of the wounds every week in the outpatients clinic.
16089321|NCT02241811|Drug|Placebo|Hydrogel without 3% Sodium Pentaborate Pentahydrate
16089322|NCT02241798|Other|oxygen|O2 by nasal prongs
16089323|NCT02241785|Drug|natalizumab|Administered as specified in the treatment arm
16089324|NCT02241772|Drug|TA-8995|
16089325|NCT02241772|Drug|Placebo|
16089326|NCT02241759|Drug|TA-8995|
16089327|NCT02241759|Drug|Moxifloxacin|
16089328|NCT02241759|Drug|Placebo|
16089329|NCT02241746|Other|no intervention|
16089330|NCT02241733|Behavioral|Breathing retraining plus exercise|Patients will participate in a 12-week exercise program with breathing retraining. They will also participate in an adherence program.
16089331|NCT02241733|Behavioral|Exercise only|Patients will participate in a 12-week exercise program . They will also participate in an adherence program.
16089332|NCT02241720|Drug|regorafenib|
16089333|NCT02241694|Other|No treatment given|No treatment given. Participants are to complete a questionnaire in the study.
16089334|NCT02241681|Dietary Supplement|Peptamen 1.5|Peptamen will be given twice at the dose of 250 mL, with an interval of 4 hours.
16089335|NCT02241668|Procedure|PET Scan|FLT Pet Scan performed about 60 minutes after 3'-Deoxy-3'-18f-Fluorothymidine solution injected.
16089336|NCT02241668|Drug|3'-Deoxy-3'-18f-Fluorothymidine|3'-Deoxy-3'-18f-Fluorothymidine solution injected through a central venous catheter after MRI scan. After solution injected into a vein, PET scanner takes pictures of the radioactive solution as it moves through the body and collects at various sites in the body. Entire procedure should last about 60-70 minutes.
16089337|NCT02241655|Device|a pragmatic EEG-guided anesthetic protocol|
16089338|NCT02241642|Device|VIVASURE CLOSURE DEVICE™|Large hole vascular closure device
16089339|NCT02241629|Drug|placebo|placebo of levo phencynonate hydrochloride
16089340|NCT02241629|Drug|levo phencynonate hydrochloride|levo phencynonate hydrochloride
16089341|NCT02241616|Drug|Entecavir+Fuzheng Huayu+TCM Granule|The subjects will be taking 1 Entecavir tablet per day, 4 Fuzheng Huayu tablets three times a day and specific Traditional Chinese Medicine granule for 48 weeks.
16089342|NCT02241603|Behavioral|Weight loss|Obese Veterans will undergo dietary education for weight loss or weight maintenance
16089343|NCT02241590|Drug|Entecavir + Placebo|The subjects will be taking 1 Entecavir tablet per day and 4 Placebo tablets three times a day for 48 weeks.
16089344|NCT02241590|Drug|Entecavir + Fuzheng Huayu Tablet|The subjects will be taking 1 Entecavir tablet per day and 4 Fuzheng Huayu tablets three times a day for 48 weeks.
16089345|NCT02241577|Procedure|Surgical treatment|Flap surgery around dental implant for scaling and disinfection of the titanium surface under local anesthesia
16089346|NCT02241577|Procedure|Non-surgical treatment|Non-surgical subgingival scaling and disinfection of the titanium surface of dental implant under local anesthesia
16089347|NCT02241564|Other|Referral to a multidisciplinary expert panel at the Uppsala University Hospital after tumor detection|
16089348|NCT02241564|Drug|Switch from calcineurin inhibitor to an mTOR inhibitor|
16089349|NCT02241551|Drug|gemcitabine/nab-paclitaxel|three cycles of treatment in the gemcitabine/nab-paclitaxel
16089350|NCT02241551|Drug|mFOLFIRINOX|6 cycles in the mFOLFIRINOX
16089351|NCT02241538|Device|Pilates 1|Combination of an educational booklet with exercises of the Pilates method. Patients will receive 6 sessions of treatment over a period of 6 weeks (1 session/week). The exercises of the Pilates method will be individualized to each patient´s needs (pragmatic treatment).
16089352|NCT02241538|Device|Pilates 2|Combination of an educational booklet with exercises of the Pilates method. Patients will receive 12 sessions of treatment over a period of 6 weeks (2 sessions/week). The exercises of the Pilates method will be individualized to each patient´s needs (pragmatic treatment).
16089353|NCT02241538|Device|Pilates 3|Combination of an educational booklet with exercises of the Pilates method. Patients will receive 18 sessions of treatment over a period of 6 weeks (3 sessions/week). The exercises of the Pilates method will be individualized to each patient´s needs (pragmatic treatment).
16089354|NCT02241538|Device|Control|Patients will receive an educational booklet containing information about the anatomy of the spine and pelvis and the low back pain and recommendations regarding posture and movements involved in activities of daily living. The participants in this group did not receive additional exercise.
16089355|NCT02241512|Drug|Ibuprofen|
16089356|NCT02241512|Drug|placebo|
16089357|NCT02241499|Radiation|Radiation therapy|Radiotherapy at a dose of 4 Gy will be given to a total dose of 20 Gy, treatment duration 5 days.
16089358|NCT02241499|Drug|Oxaliplatin and fluorouracil.|Oxaliplatin at a dose of 85 mg/m2 and will be given on day 1, infusion (44 hours) of fluorouracil will be given for 4 cycles, cycle length 14 days.
16089359|NCT02241486|Drug|Sublingual Fentanyl Spray|Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement).
16089492|NCT02240498|Drug|20% I.V. Fat Emulsion|The abscess cavity will be filled with sterile 1% Intralipid solution to gently distend the cavity and, through efficient light scattering, to homogenize the light dose to the walls of the cavity. After laser illumination, the Intralipid will be aspirated from the cavity.
16089532|NCT02240303|Procedure|Blood Sample|Participants in both groups will have blood samples taken.
16089360|NCT02241473|Other|Training|During 3 weeks (9 sessions; three sessions/wk), subject will performed 60 min walking at spontaneous walking speed in normoxic (continuous normoxic training; CNT) or hypoxic (continuous hypoxic training, CHT; simulated altitude of 3000 m) condition in a single-blind fashion. Both CNT and CHT sessions will be performed in an hypoxic chamber (ATS Altitude, Sydney, Australia) built in our laboratory at an altitude of 380 m (Lausanne, Switzerland). In order to blind subjects to altitude, the system will also run for normoxic training groups with a normoxic airflow into the chamber.
16089361|NCT02241460|Drug|Placebo|During the Double-Blind Treatment Period, patients randomized to placebo will receive three cycles of Promescent. The first and second cycle consists of three weeks of treatment using 30 mg and 50 mg, followed by one week of washout. The third cycle consists of three weeks of treatment using 70 mg. During the Open-Label Treatment Period, the patient will receive four weeks of Promescent (active treatment) in one-week cycles: 30 mg, 50 mg, 70 mg, and patient's self-selected dose.
16089362|NCT02241460|Drug|Promescent Lidocaine Spray|During the Double-Blind Treatment Period, patients randomized to active treatment will receive three cycles of Promescent. The first and second cycle consists of three weeks of treatment using 30 mg and 50 mg, followed by one week of washout. The third cycle consists of three weeks of treatment using 70 mg, followed by four weeks of treatment during the Open-Label Treatment Period using patient's self-selected dose.
16089363|NCT02241434|Biological|Stem Cell|Intrathecal autologous bone marrow mononuclear cell transplantation
16089364|NCT02241421|Drug|Amoxicillin|
16089365|NCT02241421|Drug|Vancomycin|
16089366|NCT02241421|Other|Placebo|
16089367|NCT02241395|Biological|Intrathecal autologous bone marrow mononuclear cell transplantation|
16089368|NCT02241382|Device|Internal Electrocardioversion|Cardioversion by internal shock application via the implanted ICD
16089369|NCT02241382|Device|External Electrocardioversion|Cardioversion by external shock application via a cardioverter/defibrillator.
16089370|NCT02241369|Biological|INO-3106, INO-9012|
16089371|NCT02241356|Device|bifocals|bifocal glasses with an addition of 2.5 Dioptres
16089372|NCT02241356|Device|single vision glasses|single vision glasses
16089373|NCT02241343|Device|Venous occlusion (leg tourniquet, made in-house)|Leg occlusion applied via a blood pressure cuff. Venous occlusion checked using duplex ultrasound
16089374|NCT02241330|Dietary Supplement|Biofortified wheat|Wheat was grown by foliar Zn application and is therefore biofortified
16089375|NCT02241330|Dietary Supplement|Fortification|Wheat flour is fortified before testmeal preparation
16089376|NCT02241330|Dietary Supplement|Control|wheat flour is used as control comparator.
16089377|NCT02241291|Procedure|Percutaneous coronary intervention|Non-surgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease. A deflated balloon or other device on a catheter is fed from an artery (such as the inguinal femoral artery or radial artery) up through blood vessels until they reach the site of blockage in the heart. X-ray imaging is used to guide the catheter threading. At the blockage, the balloon is inflated to open the artery, allowing blood to flow. A stent is often placed at the site of blockage to permanently open the artery
16089378|NCT02241278|Drug|Ketamine|In the operating room, the anesthesiologist administered 0.5 mg/kg of ketamine chlorhydrate in 50 mL of 0.9 % saline intravenously to patients in the ketamine group 30 minutes before surgical incision (a single dose).
16089379|NCT02241252|Device|iPhone ECG|Please see detailed description for additional information.
16089380|NCT02241226|Behavioral|Perfect Health Course|The Perfect Health course as taught at the Chopra Center for Wellbeing
16089381|NCT02241213|Device|Transcranial Magnetic Stimulation (TMS-r)|"10 sessions, each session of EMT-r will be low frequency (1 Hz for 20 minutes and a total of 1200 pulses) using a biphasic pulse stimulator, with active coil (coil-shaped focal or inactive coil placebo for 2 weeks from Monday to Friday, target: triangular portion - homologous to injury Inferior front Gyrus (GFI)."
16089382|NCT02241213|Device|Placebo Transcranial Magnetic Stimulation|10 sesions of Non- active coil, that will simulate the sound of the TMS, holding the coil on the scalp at an angle of 45 degrees in the selected area
16089383|NCT02241200|Drug|DA3880|
16089384|NCT02241200|Drug|Aranesp|
16089385|NCT02241187|Drug|PEGPH20|
16089386|NCT02241187|Drug|Cetuximab|
16089387|NCT02241187|Device|DW & DCE-MRI|
16089388|NCT02241187|Other|blood draws|Blood samples will be drawn at various time points.
16089389|NCT02241174|Drug|Sodium Hypochlorite|The 0.005% sodium hypochlorite solutions will be prepared from the commercially available Clorox® at 6% solution. 0.83ml of the 6% sodium hypochlorite solution will be taken and incorporated to a-100ml absolute distilled water. This 100ml solution will be stored in an amber glass bottle at room temperature unexposed to light at a maximum of 23 months
16089390|NCT02241161|Other|plantaricin a - rejuvenating cream|single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes
16089391|NCT02241161|Other|plantaricin a - antioxidant serum|single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes
16089392|NCT02241161|Other|plantaricin a - rejuvenating serum|single application on an area of 17,5 cm2, on the forearm, after skin stripping, and left absorbing on the skin for at least 15 minutes
16089393|NCT02241148|Drug|Acetaminophen 500mg|500 mg, tablets every 8 hours
16089394|NCT02241148|Device|Kinesio taping|Taping will be changed every week.
16089395|NCT02241135|Biological|CV7201 mRNA|CV7201 is composed of 1 RNActive® mRNA that encodes the rabies virus glycoprotein.
16089396|NCT02241122|Procedure|prostate biopsy|
16089397|NCT02241109|Other|no intervention|progression monitoring by echocardiography
16089398|NCT02241096|Drug|Lidocaine|IV lidocaine bolus of 1.5mg/kg over 10 minutes followed by a 1mg/kg/hr IV lidocaine infusion.
16089399|NCT02241083|Drug|Dopamine|
16089400|NCT02241083|Drug|Norepinephrine|
16089401|NCT02241083|Other|no medication|
16089402|NCT02241070|Behavioral|mindulness-based intervention|"A number of mindfulness techniques, including both formal and informal practices with integration in the context of Mind/Body meditation, were explored in order to cultivate moment-by-moment present awareness with non-judgmental acceptance."
16089403|NCT02241057|Device|Investigational Air-Activated Adhesive-Backed Heat Patch (3-Cell)|
16089405|NCT02241044|Device|Argon plasma coagulation|Argon plasma coagulation therapy was realized by an Olympus electrosurgical unit/APC unit (PSD-60/Endoplasma, Olympus Corporation, Tokyo, Japan), and its catheters were 2.3mm and 3.5 mm equipped with different endoscope channels.7 APC treatment used a coagulation mode at gas flow/power settings of 1.5L/min and 40 watt for duodenal ulcers and 40-60 watt for gastric ulcers.10 Operative distance between the probe and target bleeding ranged from 2 to 8 mm. Air warranted to be sucked frequently at endoscopy in an attempt at decrease of APC-induced smoke and gastric decompensation, with appropriate treatment of high-risk bleeding ulcers.
16089406|NCT02241044|Device|Distilled water|Distilled water was then applied in aliquots of 0.5-2.0 mL, at and around the site of target bleeding, up to 25.0 ml if necessary. Injection amount was determined by endoscopists according to ulcer or vessel size and its location.
16089407|NCT02241031|Biological|MPs|MPs are generated from cord blood using a combination of cytokines.
16089408|NCT02241031|Drug|thrombopoietin (TPO) and interleukin-11|Platelet stimulating factors include thrombopoietin (TPO) and interleukin-11 and so on.
16089409|NCT02241018|Drug|CD25 monoclonal antibody|
16089410|NCT02241018|Drug|calcineurin inhibitors|
16089411|NCT02241018|Biological|MSCs|
16089412|NCT02241005|Other|Theraworx™ bath wipes|Theraworx™ bath wipes will be supplied in packaging similar to the standard bath wipes used in this study. The bath wipes will be started on the day of admission, and used once daily for a period of 60 days post-HSCT.
16089413|NCT02241005|Other|Standard bath wipes|Standard bath wipes will be supplied in packaging similar to the Theraworx™ bath wipes used in this study. The bath wipes will be started on the day of admission, and used once daily for a period of 60 days post-HSCT.
16089414|NCT02240992|Biological|PBSC|
16089415|NCT02240992|Biological|MSCs|
16089416|NCT02240979|Device|cardiac MRI|cardiac MRI
16089417|NCT02240953|Drug|Warfarin|Only warfarin is given with a target INR level of 2.5-4 to the patients with prosthetic heart valve thrombosis
16089418|NCT02240953|Drug|Warfarin + ASA 100 mg + PPI|100 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin for the patients with prosthetic heart valve thrombosis
16089419|NCT02240953|Drug|Warfarin + ASA 300 mg + PPI|In the third arm 300 mg acetylsalicylic acid and a proton pump inhibitor are added to treatment in combination with warfarin for the patients with prosthetic heart valve thrombosis
16089420|NCT02240953|Drug|Observational Warfarin|This is an observational group of patients who do not have prosthetic heart valve thrombosis. These patients also are followed under only warfarin therapy with INR level of 2.5-4.
16089421|NCT02240940|Device|Parachute Implant|CardioKinetix's Parachute implant device is suitable for use in isolating the dysfunctional region of the left ventricle in patients with symptoms of heart failure due to ischemic heart disease. Potential benefits of the Parachute implant device are improvement in hemodynamics and the clinical symptoms of heart failure.
16089422|NCT02240927|Drug|Low Molecular Weight Heparine : Enoxaparine|During first trimester, warfarin is stopped and enoxaparine is started in 1mg/kg dose twice a day. Dose is adjusted according to Anti Factor Xa levels (between 0.7-1.2). Full dose warfarin is continued after first trimester and dose is regulated according to INR level (between 2.5-4).
16089423|NCT02240927|Drug|Enoxaparine and 2.5 mg Warfarin|If the patient's therapeutic warfarin dose is more than 5 mg before pregnancy, warfarin dose is decreased to 2.5 mg during the first trimester and combined with enoxaparine in 1mg/kg dose twice a day. Enoxaparine dose is adjusted according to anti-factor Xa levels (between 0.5-1). Full dose warfarin is continued after first trimester and dose is regulated according to INR level (between 2.5-4)
16089424|NCT02240927|Drug|Enoxaparine and 4mg Warfarin|If the patient's warfarin consumption dose is more than 5 mg before pregnancy, warfarin dose is decreased to 4 mg during the first trimester and combined with enoxaparine in 1mg/kg dose twice a day. Enoxaparine dose is adjusted according to anti-factor Xa levels (between 0.5-1). Full dose warfarin is continued after first trimester and dose is regulated according to INR level (between 2.5-4).
16089425|NCT02240927|Drug|Warfarin|If the patient's therapeutic warfarin dose is less than 5 mg before pregnancy, warfarin is continued in the same dose during all the pregnancy and the dose is adjusted according to INR level (between 2.5-4).
16089426|NCT02240901|Device|Laryngeal mask airway（LMA）|Laryngeal mask airway（LMA） is used to maintain mechanical ventilation during intra-operative
16089427|NCT02240901|Device|Endotracheal intubation（ETI）|Endotracheal intubation group（ETI）is used to maintain mechanical ventilation during intra-operative
16089428|NCT02240888|Biological|0,5 mg Prevenar i.m.|
16089429|NCT02240888|Biological|0,5 mg seasonal influenza vaccine i.m.|
16089430|NCT02240875|Biological|cAd3-EBO Z at 1 x 10^10 vp|Low dose cAd3-EBO Z
16089431|NCT02240875|Biological|cAd3-EBO Z at 2.5 x 10^10 vp|Medium dose cAd3-EBO Z
16089432|NCT02240875|Biological|cAd3-EBO Z at 5 x 10^10 vp|High dose cAd3-EBO Z
16089433|NCT02240875|Biological|4.4x10^8 TCID50s MVA-BN® Filo|High dose MVA-BN® Filo
16089434|NCT02240875|Biological|2.2x10^8 TCID50s MVA-BN® Filo|Low dose MVA-BN® Filo
16089435|NCT02240875|Biological|4.4 x 10^7 TCID50s MVA-BN® Filo|Very low dose MVA-BN® Filo
16089436|NCT02240862|Device|Carotid Artery Stent|Placement of a stent within the carotid artery
16089437|NCT02240849|Device|Functional pillow|streamlined shape for cervical lordosis memory foam pillow functional design considered several sleep position
16089438|NCT02240849|Device|Placebo general pillow|
16089439|NCT02240836|Other|Intervention. Exercise|Physical activity. Attendance in exercise groups 60 min. twice a week and exercise at home 120 min per week. Intervention for 12 months.
16089440|NCT02240823|Other|adipose derived stem cells|
16089441|NCT02240810|Device|Percutaneous coronary intervention (Promus PREMIER)|Interventional coronary artery stenting with Promus PREMIER study stent.
16089442|NCT02240797|Other|Positron emission tomography (PET) imaging|Positron emission tomography (PET) imaging
16089493|NCT02240498|Device|Insertion of optical fiber|A sterile, FDA-approved optical fiber will be advanced to the approximate center of the abscess cavity via the drainage catheter under image guidance. Following laser illumination, the fiber will be withdrawn.
16089494|NCT02240498|Device|Laser illumination, 5 minutes|Laser illumination will be delivered via the optical fiber for a duration of 5 minutes. The fluence rate will be set such that the maximum fluence rate at the abscess wall is 20 mW/cm2.
16089443|NCT02240771|Procedure|Transarterial chemotherapy|"Femoral artery would be punctured at the upper thigh using 18 gauge needle under local anesthesia. Catheterization of the hepatic artery feeding the tumor would be done and placing the catheter tip beyond the gastroduodenal artery, the chemotherapeutic drugs would be administered.
~Mixture would be prepared by using Doxorubicin 50mg and Cisplatin 100mg. Hydrocortisone 100mg and augmenting dose of analgesic and sedative would be injected prior to the administration of the drug.
~The drug mixture would then be injected through the indwelling arterial catheter by continuously flushing alternately, repeatedly and rapidly between two-leur lock syringes."
16089444|NCT02240771|Drug|Oral chemotherapy|"Drugs used would be Thalidomide and Capecitabine in the following dosage schedule- Thalidomide---50mg once a day (OD) for 7 days, increased to 100mg OD for 7 days, 200mgOD for 7 days further increased to 300 mg OD.
~Capecitabine---- 500mg OD for 7 days, then 1000mg OD for next 7 days, increased to a maximum dose of 1500mg OD
~Maintenance dose - Capecitabine 1500 mg - every alternate week Thalidomide - 300 mg OD. Total leucocyte count & Platelet count would be monitored every 15 days"
16089445|NCT02240758|Procedure|confocal endomicroscopy with the CELLVIZIO® system (Mauna Kea technology)|The CELLVIZIO® system (Mauna Kea technology) will be used for confocal endomicroscopy during a surgical procedure (either open surgical approach or stereotaxic biopsy). The probe dedicated to the CELLVIZIO® system will be positioned against the surface of the brain, sequences will be acquired, and finally compared with anatomapathology exams. Two specific medications will be used as contrast agent in the study: Fluorescein FAURE 500mg/5mL IV with a maximum of two doses per patient OR 5 amino-levulinic hydrochloride (GLIOLAN, MEDAC) orally at the dose of 20mg/kg of body weight.
16089446|NCT02240745|Other|Stress-echocardiography|Stress-echocardiography (incl dobutamin and atropin)
16089447|NCT02240719|Drug|everolimus|Given PO
16089448|NCT02240719|Drug|bendamustine hydrochloride|Given IV
16089449|NCT02240706|Procedure|Best Supportive Care|At Discretion of the Investigator (Transfusions)
16089450|NCT02240706|Drug|BI 836858|Monotherapy with BI 836858
16089451|NCT02240693|Drug|BI 409306|
16089452|NCT02240693|Drug|Placebo|
16089453|NCT02240693|Drug|BI 409306|
16089454|NCT02240693|Drug|Placebo|
16089455|NCT02240693|Drug|Placebo|
16089456|NCT02240693|Drug|BI 409306|
16089457|NCT02240693|Drug|BI 409306|
16089458|NCT02240693|Drug|Placebo|
16089459|NCT02240693|Drug|Placebo|
16089460|NCT02240680|Drug|placebo|placebo matching linagliptin 5 mg
16089461|NCT02240680|Drug|linagliptin|5 mg once a day
16089462|NCT02240667|Drug|Dabigatran etexilate|150 mg or 110 mg capsules twice daily
16089463|NCT02240667|Drug|Vitamin K antagonists|International Normalized Ratio (INR) 2-3
16089464|NCT02240641|Drug|Lacidipine|
16089465|NCT02240641|Drug|Diuretics|
16089466|NCT02240641|Drug|antihypertensive drugs|
16089467|NCT02240641|Drug|alpha blockers|
16089468|NCT02240641|Drug|Angiotensin-Converting Enzyme Inhibitors|
16089469|NCT02240641|Drug|beta blockers|
16089470|NCT02240628|Device|Lidocaine/tetracaine transdermal patch|All patients in arm 1 and arm 2 will receive the Synera Patch.
16089471|NCT02240628|Drug|Saline|Patients in arm 2 will receive Saline with the Propofol.
16089472|NCT02240628|Drug|Lidocaine|Patients in arm 1 will receive Lidocaine with the Propofol.
16089473|NCT02240615|Device|Sinopsys Lacrimal Stent|Procedural insertion of the Sinopsys Lacrimal Stent in patients with epiphora
16089474|NCT02240602|Drug|Oxycodone, 1.00 mg dose|Intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 1.00 mg.
16089475|NCT02240602|Drug|Oxycodone, 0.03 mg/kg dose|Intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 0.03 mg/kg.
16089476|NCT02240602|Drug|Oxycodone, 0.02 mg/kg dose|intravenous oxycodone is provided as patient-controlled analgesia after surgery with bolus dose of 0.02 mg/kg.
16089477|NCT02240589|Drug|Memantine|Day 1 to 3: 10 mg bid memantine. Day 3 to 21: 20 mg bid memantine. Day 21 to 168: 10 mg bid memantine.
16089478|NCT02240589|Drug|Placebo|Day 1 to 3: 10 mg bid placebo. Day 3 to 21: 20 mg bid placebo. Day 21 to 168: 10 mg bid placebo.
16089479|NCT02240563|Procedure|Low-level laser therapy|
16089480|NCT02240563|Procedure|Non laser ordinary red light|
16089481|NCT02240550|Device|ProFlor Hernia Repair System|The 3-D hernia mesh will be used in the repair of your inguinal hernia.
16089482|NCT02240550|Device|Lichtenstein hernia repair|The standard Lichtenstein hernia repair with flat mesh will be used in the treatment of your inguinal hernia.
16089483|NCT02240537|Drug|Sargramostim|Drug: Sargramostim (GM-CSF) Other Names: Leukine Sargramostim (250 ug vial) is reconstituted with 0.5 ml of Sterile Water for Injection. Subjects will receive 0.5 ml intradermally (250 µg) near the arm pit or inside of thigh.
16089484|NCT02240537|Drug|BB-MPI-03|Other Names: Multi-peptide immunotherapy (MPI) is comprised of 3 cytotoxic T-cell epitopes derived from oncofetal antigen. There are 3 dose levels of study vaccine planned to be tested, starting at 0.25 mg each peptide (0.75 mg total peptide dose), then 0.5 mg of each peptide (1.5 mg total) and finally 1 mg each peptide (3 mg total). At the starting dose of 0.75 mg, the BB MPI 03-15 mg vial is used and 100 ul is administered; at the 1.5 mg dose, 200 ul of the BB MPI 03-15 mg vial is used; at the 3 mg dose, 200 ul of the BB MPI 03-30 mg is used.
16089485|NCT02240537|Drug|Montanide|"Drug: Montanide Other Names: mineral oil, USP BB-MPI-03 is emulsified with Montanide and administered intradermally (ID) within 1-2 cm of the 2 sargramostim injection sites 1-3 minutes after sargramostim administration.
~Subjects and the injection sites are to be monitored for 1 hour after sargramostim and BB-MPI-03 emulsion administration."
16089486|NCT02240524|Procedure|D2 lymphadenectomy|The dissected lymph nodes were classified according to the Japanese Classification of Gastric Carcinoma, first English edition.
16089487|NCT02240524|Procedure|Systemic chemotherapy|
16089488|NCT02240524|Procedure|HIPEC|
16089489|NCT02240511|Dietary Supplement|RE and BCAA Supplementation|RE: Resistance Exercise BCAA: Branched Chain Aminoacids
16089490|NCT02240511|Other|Resistance Exercise|
16089491|NCT02240498|Drug|Methylene Blue|Administration of 1 mg/mL methylene blue to the abscess cavity, followed by a 10 minute incubation interval. After this incubation interval, the methylene blue solution will be aspirated from the cavity and flushed twice with sterile saline.
16089495|NCT02240498|Device|Laser illumination, 10 minutes|Laser illumination will be delivered via the optical fiber for a duration of 10 minutes. The fluence rate will be set such that the maximum fluence rate at the abscess wall is 20 mW/cm2.
16089496|NCT02240498|Device|Laser illumination, 15 minutes|Laser illumination will be delivered via the optical fiber for a duration of 15 minutes. The fluence rate will be set such that the maximum fluence rate at the abscess wall is 20 mW/cm2.
16089497|NCT02240498|Device|Laser illumination, 20 minutes|Laser illumination will be delivered via the optical fiber for a duration of 20 minutes. The fluence rate will be set such that the maximum fluence rate at the abscess wall is 20 mW/cm2.
16089498|NCT02240498|Device|Laser illumination, 25 minutes|Laser illumination will be delivered via the optical fiber for a duration of 25 minutes. The fluence rate will be set such that the maximum fluence rate at the abscess wall is 20 mW/cm2.
16089499|NCT02240498|Device|Laser illumination, 30 minutes|Laser illumination will be delivered via the optical fiber for a duration of 30 minutes. The fluence rate will be set such that the maximum fluence rate at the abscess wall is 20 mW/cm2.
16089500|NCT02240485|Behavioral|Couple therapy|"The experimental couple treatment is offered over 8 to 12 sessions of 90 minutes. The couple treatment called (Integrative Couple Therapy for Pathological Gambling - ICT-PG) is inspired by the Alcohol Behavior Couple Therapy from Epstein and McCrady, to which the team added diverse components to adjust to gamblers. During the sessions, the focus is on a) reducing/stopping gambling behaviors, b) helping the partner to stop behaviors facilitating gambling habits and rise the frequency of behaviors imcompatibles with gambling habits and c) improve marital components (communication, sharing positive moments, negotiation, mutual support)."
16089501|NCT02240485|Behavioral|Usual individual/group treatment|The control group receive individual or group treatment as already offered by the specialized centers in addiction.Their partner can receive individual intervention if desired.
16089502|NCT02240472|Procedure|Omission of axillary clearance|The intervention is the omission of completion axillary clearance after the detection of sentinel node macrometastasis
16089503|NCT02240459|Drug|fesoterodine 4mg|7 days therapy followed by seven days washout. Each 4mg tablet is taken in the morning
16089504|NCT02240459|Drug|Oxybutynin|5mg IR oxybutynin taken bid, encapsulated into a form indistinguishable from placebo
16089505|NCT02240459|Drug|placebo|placebo capsule, one twice daily, and 2 placebo fesoterodine tablets taken each morning for masking and comparator purposes
16089506|NCT02240459|Drug|fesoterodine 8mg|2, 4mg fesoterodine capsules taken together in the morning
16089507|NCT02240446|Device|Active tDCS|2mA stimulation for 20 minutes twice a day for five consecutive days
16089508|NCT02240446|Device|Sham tDCS|2mA for 30 seconds twice a day for five consecutive days
16089509|NCT02240433|Drug|LY2157299|LY2157299 administered orally
16089510|NCT02240433|Drug|Sorafenib|Sorafenib administered orally
16089511|NCT02240420|Behavioral|Life Style Counseling (Star-Mama)|"Participants enrolled in the Star-Mama intervention group will receive 1. weekly automated phone calls with prevention-focused queries (e.g., diet, exercise, breastfeeding). 2. If a participant generates a value rated out of range, a health coach who receives daily electronic downloads of STAR-Mama responses will call the participant to coach her about the specific health issue. Participants also hear recorded narratives related to their out of range reply encouraging behavior change. 3. Call-backs enable coaches to engage patients in goals setting/action plans and providing information about community resources"
16089512|NCT02240407|Genetic|Recombinant Adeno-Associated Virus Acid Alpha-Glucosidase|The dose selected for this study is a fixed dose of 4.6 x 10^13 vg per TA muscle (range of 7.64 x 10^11 vg/gm to 4.6 x 10^11 vg/gm based on TA weight).
16089513|NCT02240407|Drug|Rapamycin|Patients will receive Rapamycin (dose 0.6-2 mg/m^2/day, adjusted to maintain a trough serum sirolimus level of 2-4 ng/mL.) every day starting from 7 days before first injection of AAV9 until four months after second injection.
16089514|NCT02240407|Other|saline|Same volume as rAAV9-DES-hGAA injection will be used.
16089515|NCT02240407|Drug|Rituxan|Patients will receive Rituxan (dose: 750 mg/m^2 twice) 21 and 7 day prior first AAV9 injection, with a Rituxan dose 375 mg/m^2 on the day of the injection. Rituxan will be repeated 7 days prior to the 2nd injection of the vector. The maintenance dose of Rituxan will be 375 mg/m^2.
16089516|NCT02240407|Drug|Diphenhydramine|25-50mg will be provided before each Rituximab dose.
16089517|NCT02240407|Drug|Acetaminophen|We will provide 650 mg of tylenol before each dose of Rituximab.
16089518|NCT02240407|Drug|Lidocaine|Lidocaine will be used based on standard of care: Percutaneous infiltration, concentration 0.5-1%, 1-10 mL, 5-300mg total dose.
16089519|NCT02240407|Drug|LMX 4 Topical Cream|Topical anesthesia cream will be used prior to gene therapy/saline injection.
16089520|NCT02240381|Procedure|assessment of therapy complications|During OGTT 75gm of glucose will be given followed by phlebotomy
16089521|NCT02240381|Procedure|assessment of therapy complications|During clamp procedure tritiated glucose, D20, regular insulin will be given, followed by phlebotomy.
16089522|NCT02240381|Other|laboratory biomarker analysis|Correlative studies
16089523|NCT02240355|Drug|RO6885247|oral solution
16089524|NCT02240355|Drug|placebo|oral solution
16089525|NCT02240342|Drug|Bone marrow transplant into ovarian artery|Bone marrow progenitors mobilized to peripheral blood, obtained by plasmapheresis and infused into the ovarian artery
16089526|NCT02240329|Behavioral|Neuropsychological Testing and Measures of TBI severity|A brief cognitive assessment will be given to each participant when he or she presents for this project.
16089527|NCT02240329|Behavioral|Respiratory measures|We will collect measures of cough airflow and breathing strength.
16089528|NCT02240329|Drug|Capsaicin cough sensitivity testing|Subjects will inhale a saline vapor mixed with various concentrations of capsaicin powder in order to determine how sensitive his or her cough response is.
16089529|NCT02240303|Procedure|Quantitative Sensory Testing (QST)|Participants in both groups will have a sensory assessment called quantitative sensory testing or QST that will assess in detail your ability to feel sensations due to touch, vibration, and changes in temperature on the skin.
16089530|NCT02240303|Procedure|Physical Performance|Participants in both groups will have a Physical Performance test.
16089531|NCT02240303|Procedure|Magnetic Resonance Imaging (MRI)|Participants in both groups will have an magnetic resonance imaging (MRI).
16090383|NCT02233816|Biological|Placebo|A single dose of placebo
16089533|NCT02240290|Drug|tozadenant tablet|Active substance: tozadenant Pharmaceutical form: Tablet Concentration: 240 mg Route of Administration: Oral administration
16089534|NCT02240290|Drug|C14-tozadenant capsule|Active substance: C14-tozadenant Pharmaceutical form: Capsule Concentration: 74 kBq (2 μCi) Route of administration: Oral administration
16089535|NCT02240264|Dietary Supplement|Krill oil capsules|1 year supplementation with Krill oil provided by Aker BioMarine Antarctic AS equalling almost the daily recommended amount of 450 mg of EPA/DHA intake per day.
16089536|NCT02240264|Dietary Supplement|Placebo|Capsules containing a fatty acid mixture that reflects the fatty acid composition of the average European diet.
16089537|NCT02240251|Other|Prospective Chart Review|The laser assisted IVC filter removal procedure itself is not part of this study. This is a prospective chart review for patients undergoing this procedure.
16089538|NCT02240238|Drug|NC-6004|NC-6004 - given at escalating doses of 60, 75, 90, 105, 120, 135, 150, 165, or 180 mg/m2 according to observations of dose-limiting toxicity.
16089539|NCT02240238|Drug|Gemcitabine|Gemcitabine 1250 mg/m2 will be administered as a 30 minute intravenous infusion on Day 1 after the completion of the NC 6004 infusion and on Day 8 of each cycle.
16089540|NCT02240212|Drug|Afuresertib|The unit dose strength is 50mg/75mg tablet. Afuresertib will be taken orally once daily continuously during trail.
16089541|NCT02240212|Drug|Paclitaxel|Paclitaxel sourced locally will be administered IV
16089542|NCT02240199|Drug|Intraoperative Intravenous Lidocaine Infusion|Lidocaine 1.5 mg/kg bolus with anesthesia induction followed by 2 mg/kg/hr infusion before the start of surgical incision and stopped at surgical closure.
16089543|NCT02240199|Drug|Perioperative Pregabalin|Pregabalin 300 mg preoperatively (e.g. 2 hours prior to the start of surgery) and 75 mg twice a day for 9 days after surgery.
16089544|NCT02240199|Drug|Perioperative Pregabalin Placebo|Pregabalin placebo 300 mg preoperatively (e.g. 2 hours prior to the start of surgery) and 75 mg twice a day for 9 days after surgery.
16089545|NCT02240199|Drug|Intraoperative Intravenous Lidocaine Placebo Infusion|Lidocaine placebo 1.5 mg/kg bolus with anesthesia induction followed by 2 mg/kg/hr infusion before the start of surgical incision and stopped at surgical closure.
16089546|NCT02240186|Device|Microprocessor Knee (MPK)|MPKs are prosthetic knees that use a microprocessor to control the prosthetic knee mechanism and adjust knee stiffness.
16089547|NCT02240186|Device|Non-Microprocessor Knee (NMPK)|A NMPK is a mechanical knee with either hydraulic or pneumatic controls.
16089548|NCT02240173|Dietary Supplement|Jobelyn|Jobelyn is a dietary supplement made from Sorghum bicolor
16089549|NCT02240173|Drug|Haloperidol|Conventional drug normally used for psychotic problems
16089550|NCT02240160|Drug|Sativex|Oromucosal spray containing THC (27 mg/mL) and CBD (25 mg/mL) in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Each 100 μL spray delivers 2.7 mg THC and 2.5 mg CBD.
16089551|NCT02240147|Behavioral|home-based exercise training|During a 30 minute face-to-face motivational interview with an exercise specialist, the patient will be advised and coached about his exercise prescription, on how to implement it in his own daily life and on how to prevent relapse. Furthermore, the patients will receive instructions on how to monitor their exercise intensity and on recognizing adverse signals. During the following 12 weeks, patients will be asked to exercise 4.5 hours per week within the prescribed exercise intensity range according to the guidelines.
16089552|NCT02240134|Behavioral|Education Intervention (Tx1)|The intervention will be a combination of a strong education campaign coupled with the distribution of inexpensive tools to the homes that will enable the residents to burn wood more efficiently.
16089553|NCT02240134|Device|Air Filtration Unit Treatment (Tx2)|"A 20 x 18 Filtrete air filtration unit (Ultra Clean Air Purifiers, 3M, St. Paul, MN) will be placed in the same room as the wood stove. These units are rated by their ability to provide an equivalent amount of contaminant free air into the space, and have a smoke Clean Air Delivery Rate of 112. The electrostatically charged filters in these units are approximately 85% efficient at removing 0.2 micron particles (cigarette smoke size particles) and over 95% efficient at removing 3 micron particles. The unit will be operated on the high setting throughout the duration of the six-month assessment winter periods. Filters will be changed out by the Community Coordinator approximately once per month in an effort to maximize collection efficiency."
16089554|NCT02240134|Device|Placebo Intervention (Tx3)|"Similar to Tx1, a 20 x 18 Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter."
16089555|NCT02240121|Drug|Rifaximin EIR|Rifaximin EIR tablets will be administered per the dose and schedule specified in the arm.
16089556|NCT02240121|Drug|Placebo|Placebo matching to rifaximin EIR tablets will be administered per the dose and schedule specified in the arm.
16089557|NCT02240108|Drug|Rifaximin EIR|Rifaximin EIR tablets will be administered per the dose and schedule specified in the arm.
16089558|NCT02240108|Drug|Placebo|Placebo matching to rifaximin EIR tablets will be administered per the dose and schedule specified in the arm.
16089559|NCT02240095|Behavioral|Intervention A - Online Clinical Questions Recorder|Students allocated to this intervention will receive access to an online recorder for the clinical questions at the point of care. The recorder is accessible across a wide range of devices including phones, tablets, and desktop computers.
16089560|NCT02240095|Behavioral|Intervention B - Online Evidence Retrieval Coach|Students allocated to this intervention will receive online guidance, embedded in the MPFS search engine, in the form of short videos, animations, demos and tips and tricks regarding evidence retrieval.
16089561|NCT02240095|Behavioral|Intervention C - Online Audit and Feedback|Students allocated to this intervention will receive feedback on their current search performance compared to their peers, both online when using MPFS as well as by e-mail.
16089562|NCT02240082|Behavioral|Web-Based COPing with Shiftwork Program|COPing with Shift Work is an interactive, web-based program designed specifically for law enforcement officers to assist with the management of health and lifestyle challenges associated with shift work. The program will contain modules on sleep, physical activity, and nutrition in order to improve the health and safety of law enforcement officers and reduce their risk of chronic diseases associated with shift work. These modules will contain interactive assessments and cutting-edge scientific information on sleep, nutrition, and physical activity. Based on user input, officers will receive personalized feedback, tools, and strategies
16089563|NCT02240069|Behavioral|Education (Tx1)|Education on best burn practices
16089564|NCT02240069|Device|Air Filtration Unit Treatment (Tx2)|"A 20 x 18 Filtrete air filtration unit (3M, St. Paul, MN) will be placed in the same room as the wood stove"
16089565|NCT02240069|Device|Placebo Intervention (Tx3)|"A 20 x 18 Filtrete air filtration unit will be installed within the wood stove home. Instead of a high efficiency filter, the units will utilize a placebo filter."
16089566|NCT02240043|Other|growth hormone secretion|The glucagon stimulation test (GST) was performed by intramuscular injection of 1 mg of glucagon (Glucagen® Hypokit, Novo Nordisk A/S, Denmark). The blood samples were collected at baseline and after 90 minutes, 120 minutes, 150 minutes and 180 minutes of glucagon injection for GH and cortisol measurements. The subjects were recumbent during the test, and a cannula was maintained in a vein in the arm or forearm with a saline solution slowly infused to avoid multiple punctures.
16089567|NCT02240030|Drug|CVT-301 Low Dose|
16089568|NCT02240030|Drug|CVT-301 High Dose|
16089569|NCT02240030|Other|Placebo|
16089570|NCT02240017|Drug|Carboplatin|Carboplatin AUC (area under curve) 4,5 at day 1 of each cycle until 6 cycles.
16089571|NCT02240017|Drug|Fractionated Cisplatin|Cisplatin 35mg/m² at day 1 and day 8 of each cycle until 6 cycles.
16089572|NCT02240017|Drug|Gemcitabine|Gemcitabine 1000mg/m² at day 1 and day 8 of each cycle until 6 cycles.
16089573|NCT02240004|Device|SUPRA HFR|usual dialytic prescription for duration, frequency, acid buffer and anticoagulation regimen
16089574|NCT02239991|Procedure|Thromboelastometry|Group of cirrhotic bleeding patients that are treated with a bed side, point of care protocol based on thromboelastometry to guide transfusion and manage coagulopathy
16089575|NCT02239978|Behavioral|Postural perturbation|Participants will undergo between 50 and 100 postural perturbations (quick movements of the support surface) in multiple directions. These perturbations will be between 9 and 24cm, and between 18 and 56 cm/s depending on participant tolerance.
16089576|NCT02239952|Drug|Sunitinib|50 mg once daily, oral use for 14 days
16089577|NCT02239952|Drug|vandetanib|300 mg, once daily, oral use for 14 days
16089578|NCT02239952|Drug|Erlotinib|150 mg, once daily, oral use for 14 days
16089579|NCT02239939|Behavioral|Vest|light weight, adjustable, vest to be worn underneath clothes that weight can be added to
16089580|NCT02239939|Behavioral|Diet|Participants will undergo a 22 week dietary weight loss intervention which will incorporate dietary practices for achieving weight loss while minimizing muscle and bone loss. Participants will be instructed by the Registered Dietitian to follow a low calorie diet. Individual calorie goals will be adjusted during the study if necessary to achieve a targeted weight loss goal of at least 8%, but no more than 12%, within the intervention time frame.
16089581|NCT02239926|Drug|Ranolazine|On January 31, 2006, ranolazine was approved for use in the United States by the Food and Drug Administration (FDA) for the treatment of chronic angina pectoris.
16089582|NCT02239926|Drug|Placebo|
16089583|NCT02239913|Drug|Cocaine|The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and topiramate.
16089584|NCT02239913|Drug|Placebo|The pharmacodynamic effects of placebo will be determined during maintenance on placebo and topiramate.
16089585|NCT02239913|Drug|Phentermine|The pharmacodynamic effects of phentermine maintenance will be determined during maintenance on placebo and topiramate.
16089586|NCT02239913|Drug|Topiramate|The pharmacodynamic effects of chronic topiramate will be determined.
16089587|NCT02239900|Drug|Ipilimumab|"Treatment Group 1 and 3: Ipilimumab 3 mg/kg by vein on Day 1 of all 21 day cycles for a total of 4 doses.
~Treatment Group 2 and 4: Ipilimumab 3 mg/kg by vein on Day 1 of Cycles 1 and 2. After SBRT treatment, Ipilimumab given on Day 1 of Cycles 3 and 4.
~Treatment Group 5: Ipilimumab 3 mg/kg by vein on Day 1 of Cycle 1. After SBRT treatment, Ipilimumab given on Day 1 of Cycles 2-4"
16089588|NCT02239900|Radiation|Stereotactic Body Radiation Therapy (SBRT)|"Treatment Group 1 and 3: SBRT 50 Gy in 4 fractions to 1 - 4 liver lesion(s) on Days 1 - 4 of Cycle 1.
~Treatment Group 2 and 4: SBRT 50 Gy in 4 fractions to 1-4 liver lesion(s) on Days 29 - 33 of each 21 day cycle.
~Treatment Group 5: SBRT 60 Gy in 10 fractions to 1 - 4 lung, liver, or adrenal lesion (s) on Days 1 - 5 and Days 9 - 12 of Cycle 1."
16089589|NCT02239887|Device|WaveCrest LAA occlusion device|Left Atrial Appendage Occlusion
16089590|NCT02239874|Dietary Supplement|Vitamin D and fish oil placebo|Vitamin D3 (cholecalciferol), 2000 IU per day and fish oil placebo
16089591|NCT02239874|Dietary Supplement|Fish oil and vitamin D placebo|840 mg of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA])
16089592|NCT02239874|Dietary Supplement|Vitamin D placebo and fish oil placebo|placebo
16089593|NCT02239874|Dietary Supplement|Vitamin D and fish oil|Vitamin D3 (cholecalciferol), 2000 IU per day and 840 mg of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA])
16089595|NCT02239835|Drug|Tipranavir (TPV) low dose|
16089596|NCT02239835|Drug|Tipranavir (TPV) high dose|
16089597|NCT02239835|Drug|Ritonavir low dose|
16089598|NCT02239835|Drug|Ritonavir high dose|
16089599|NCT02239835|Drug|Saquinavir|
16089600|NCT02239822|Procedure|Stimulation of the trigeminal nerve (active stimulation)|"Participants will be randomized to active vs. sham stimulation during a period of 24 weeks with a one-way cross over at 12 weeks.
~After 12 weeks, the participants receiving active electrical stimulation will continue under active stimulation until completion of the study.
~Participants randomized to sham stimulation will be shifted to active stimulation and will be followed-up until completion of the study.
~The study will be unblinded after 6 months of randomized stimulation. The second part of the study will be an open label prospective trial for evaluate long-term follow-up. The duration of the open label trial will be more 24 weeks. the duration of the open label trial will be more 24 weeks."
16089601|NCT02239822|Procedure|Placebo stimulation of the trigeminal nerve (placebo)|"Participants will be randomized to active vs. sham stimulation during a period of 24 weeks with a one-way cross over at 12 weeks.
~After 12 weeks, the participants receiving active electrical stimulation will continue under active stimulation until completion of the study.
~Participants randomized to sham stimulation will be shifted to active stimulation and will be followed-up until completion of the study.
~The study will be unblinded after 6 months of randomized stimulation. The second part of the study will be an open label prospective trial for evaluate long-term follow-up. The duration of the open label trial will be more 24 weeks."
16089602|NCT02239809|Procedure|Stimulation of the trigeminal nerve (active stimulation)|"Participants will be randomized to active vs. sham stimulation during a period of 24 weeks with a one-way cross over at 12 weeks.
~After 12 weeks, the participants receiving active electrical stimulation will continue under active stimulation until completion of the study.
~Participants randomized to sham stimulation will be shifted to active stimulation and will be followed-up until completion of the study.
~The study will be unblinded after 6 months of randomized stimulation. The second part of the study will be an open label prospective trial for evaluate long-term follow-up. The duration of the open label trial will be more 24 weeks."
16089603|NCT02239809|Procedure|Placebo stimulation of the trigeminal nerve (placebo)|"Participants will be randomized to active vs. sham stimulation during a period of 24 weeks with a one-way cross over at 12 weeks. Patients of the placebo group will be implanted with a lead in the V1 branch of the trigeminal nerve, but will not receive stimulation.
~After 12 weeks, the participants receiving active electrical stimulation will continue under active stimulation until completion of the study.
~Participants randomized to placebo stimulation will be shifted to active stimulation and will be followed-up until completion of the study.
~The study will be unblinded after 6 months of randomized stimulation. The second part of the study will be an open label prospective trial for evaluate long-term follow-up. The duration of the open label trial will be more 24 weeks."
16089604|NCT02239796|Device|NeuroTrac continence stimulators|"Electrically stimulating the sacral nerve plexus modulates the L4-S3 nerve roots that control bladder function and urethral sphincter activity to eliminate inappropriate detrusor contractions while leaving the micturition reflex intact.
~Transcutaneous posterior tibial nerve stimulation (TPTNS) is a technique of non-invasive retrograde electrical stimulation of the sacral plexus via the sciatic nerve. The posterior tibial nerve, a tributary of the sciatic nerve, is accessed using surface electrodes applied to the medial malleolar area. We are using NeuroTrac continence stimulators."
16089605|NCT02239796|Device|NeuroTrac continence stimulators|We are using NeuroTrac continence stimulators.
16089606|NCT02239783|Device|total hip arthroplasty implant|
16089607|NCT02239770|Drug|Nicotine Film|Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
16089608|NCT02239770|Drug|Placebo Nicotine Film|Nicotine orally dissolving films (ODF) are films containing nicotine (0, 2, or 4 mg). The active pharmaceutical ingredient in Nicotine ODF is nicotine polacrilex (20%, USP). The film used in Nicotine ODF has a muco-adhesive property, i.e. it can adhere to the oral mucosa and allow the drug to be absorbed through oral mucosa. After placement in the oral cavity, nicotine ODF dissolves over a 5-10 minute period.The unit-dose dosage is in the form of 1 in x 1 in square and weighs about 100 mg. Nicotine films are not available in the United States in a non-investigational setting.
16089609|NCT02239757|Procedure|Left radial approach|Primary PCI performed through left radial approach.
16089610|NCT02239757|Procedure|Right radial approach|Primary PCI performed through right radial approach.
16089611|NCT02239744|Behavioral|Air purifiers|The 10 dormitory rooms were randomized into two groups of 5 rooms each. One group used an air purifier placed in the center of the room for 48 hours corresponding to one weekend, followed by a 2-week washout period, and another 48 hours of using a sham air purifier under the same conditions. The other group simply reversed the order in which the real and sham air purifiers were used. All rooms used the same qualified air purifiers (model FAP04, 3M Filtrete), with the only difference being removal of the filter gauze in the sham purifiers. The air pollution auto-sensing feature of air purifiers was disabled in both groups. All participants and research staff were blinded to the group assignment. We requested all participants to stay in their dormitory room with the windows/doors closed throughout each 48-hour intervention period.
16089612|NCT02239731|Drug|FDX104 (4% Doxycycline)|FDX104 - 4% or Placebo to be applied twice twice daily during 5 weeks
16089613|NCT02239718|Procedure|2-unit cantilevered resin bonded bridge|Use one tooth as abutment tooth to replace one adjacent missing tooth
16089614|NCT02239718|Procedure|3-unit fixed movable resin bonded bridge|Use teeth from both side of the missing tooth space to replace a tooth. The prosthesis is cast in two piece and connected with a fixed-movable joint (semi-precision, allow degree of movement).
16089615|NCT02239692|Drug|PICOPREP|Sodium Picosulfate, Magnesium Oxide and Citric Acid as PICOPREP powder for oral solution
16089616|NCT02239679|Drug|Aminolevulinic Acid|20% ALA applied to face for one hour prior to 10 J/cm2 blue light
16089617|NCT02239679|Drug|Topical Solution Vehicle|Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to face one hour prior to 10 J/cm2 blue light
16089618|NCT02239679|Device|BLU-U|10 J/cm2 blue light delivered at 10 mW/cm2
16089619|NCT02239679|Procedure|Cryotherapy|Liquid nitrogen cryotherapy by standard of care method to all visible/palpable actinic keratosis (AK) lesions at screening.
16089620|NCT02239666|Other|NIS|This is a non-interventional study (NIS) of usual care over the 12 months following initiation of biologic therapy.
16089621|NCT02239653|Behavioral|Physician communication|
16089622|NCT02239627|Drug|Epidural steroid|
16089623|NCT02239627|Drug|Clonidine|
16089624|NCT02239614|Biological|TDENV-LAV|0.5 mL of the post-transfection LAV F17 vaccine
16089625|NCT02239614|Biological|TDENV-PIV 4 µg + alum adjuvant|0.5 mL of DENV serotypes 1-4 (4 µg / serotype) in alum adjuvant
16089692|NCT02238951|Other|Mobile Health (mHealth)|Participants receive care coordination throughout their chemotherapy treatment using mHealth technology
16090418|NCT02233569|Device|Ventralight ST implant|
16089626|NCT02239601|Other|Physical Therapy|Physical therapy assessment and treatment for any positive signs of nerve entrapment prior to chemotherapy including nerve gliding exercises, education and splinting. A home program was provided and continued throughout chemotherapy treatment
16089627|NCT02239588|Other|Oral consumption|"Daily oral consumption for 12 weeks:
~Placebo;
~Pure Canterbury;
~Other infant formula milk powder:
~Yashili Ambery Infant Formula Milk Powder (Stage 1 0-6 months)
~Yashili Newwit Infant Formula Milk Powder (Stage 1 0-6 months)
~Yashili α-golden stage Infant Formula Milk Powder (Stage 1 0-6 months)
~Abbott Similac Infant Formula Milk Powder (Stage 1 0-6 months)
~Wyeth S-26 SMA Gold Infant Formula Milk Powder (Stage 1 0-6 months)
~Beingmate Love plus Infant Formula Milk Powder (Stage 1 0-6 months)"
16089628|NCT02239562|Drug|sPIF|
16089629|NCT02239562|Drug|Placebo|
16089630|NCT02239549|Device|Jumbo cold forceps polypectomy|The specific jumbo cold forceps used are the Olympus EndoJaw Biopsy Forceps (open jaw diameter 8.5 mm) and the Boston Scientific RJ4 Biopsy Forceps (open jaw diameter 8.8 mm).
16089631|NCT02239549|Device|Cold snare polypectomy|The specific cold snares used are the Boston Scientific Captiflex Extra Small Oval Flexible Snare (loop width 11 mm), the US Endoscopy Dsnare Dimunitive Polypectomy and Suction System (loop width 9 mm), or the Boston Scientific Sensation Short Throw Oval Flexible Snare (loop width of 13 mm, 27 mm, or 30 mm).
16089632|NCT02239536|Procedure|hot snare polypectomy|hot snare polypectomy using electrosurgical snare with application of electrocautery for eligible polyps
16089633|NCT02239536|Procedure|hot snare polypectomy after saline injection|hot snare polypectomy after saline injection using electrosurgical snare with application of electrocautery for eligible polyps
16089634|NCT02239523|Procedure|Letter Group|At time of discharge from the hospital, patients will be sent home with a letter that includes standard recommendations for evaluation and treatment for osteoporosis. This will be asked to give the letter to their primary care physician.
16089635|NCT02239523|Procedure|Intervention Group|The orthopedic department will be responsible for arranging bone density testing (DEXA) and recommending specific medication after discharge. A research assistant will call monthly to encourage treatment.
16089636|NCT02239510|Drug|Senna|1 capsule (50 mg) Senna daily for 12 weeks
16089637|NCT02239510|Drug|Linzess|1 capsule (145 mcg) of Linzess once daily for 12 weeks
16089638|NCT02239497|Procedure|Femoral block by ultrasound and neurostimulation|
16089639|NCT02239497|Drug|Intravenous analgesia|Intravenous analgesia with ketoprofen, dipyrone and dexamethasone. IV morphine to rescue analgesia
16089640|NCT02239484|Drug|Tadalafil|
16089641|NCT02239484|Drug|Tamsulosin|
16089642|NCT02239484|Drug|Tadalafil + Tamsulosin|
16089643|NCT02239458|Drug|Saxagliptin|
16089644|NCT02239445|Drug|chloral hydrate Group|chloral hydrate 0.25 mg/kg oral solution diluted with oral syrup to 5 ml and 0.2 mL intranasal placebo (normal saline)
16089645|NCT02239445|Drug|low dose dexmedetomidine group|Group L received intranasal dexmedetomidine at 1mcg/kg and 5 ml oral syrup
16089646|NCT02239445|Drug|high dose dexmedetomidine group|Group H received intranasal dexmedetomidine at 2mcg/kg and 5 ml oral syrup
16089647|NCT02239419|Procedure|CO2-Enriched Tap Water (Carbothera)|Participants will undergo foot bathing with CO2-enriched tap water (CO2 concentration, 1000-1200 ppm) maintained at a temperature of 37˚C with an immersion time of 15 mins, 3 times per week for 4 consecutive months. Participants will be rested on a chair for 15 min before foot bathing. If participant is undergoing hemodialysis, foot bathing will occur prior to their routine hemodialysis procedure.
16089648|NCT02239419|Procedure|Non-CO2-Enriched Tap Water|Participants will undergo foot bathing with non-CO2-enriched tap water maintained at a temperature of 37˚C with an immersion time of 15 mins, 3 times per week for 4 consecutive months. Participants will be rested on a chair for 15 min before foot bathing. If participant is undergoing hemodialysis, foot bathing will occur prior to their routine hemodialysis procedure.
16089649|NCT02239393|Biological|Mesenchymal Stem Cells|"Mesenchymal Stem Cells in Plasma-Lyte A (Baxter) suspension media, containing 5% Human Albumin and 10% dimethylsulfoxide (DMSO, total volume of 5mL DMSO in final cell product) and autologous MSCs at a dose of 1 to 2 x 106 MSC/Kg participant's body weight at randomization.
~Matching placebo Plasma-Lyte A (Baxter) suspension media, containing 5% Human Albumin and 10% DMSO (total volume of 5mL DMSO in final cell product)."
16089650|NCT02239380|Drug|Lorazepam|"intravenous administration. Dosage for adult subjects (16 years aged and over): 4 mg Dosage for pediatric subjects (3 months to < 16 years): 0.05 mg/kg (but not exceeding 4 mg) Frequency: Intravenous administration of lorazepam. Subjects whose seizure does not stop or recurs within 10 minutes after the initial dose may receive the same amount of lorazepam injection no earlier than 10 minutes following the initial dose.
~Also, subjects whose seizure stops within 10 minutes after the initial dose, but recurs thereafter (within 12 hours) may receive the same amount of lorazepam injection; a total of 2 doses will be permitted in this study."
16089651|NCT02239367|Behavioral|Depression Decision Aid|The Depression Decision Aid protocol, integrated into the Electronic Health Record (EHR), is a streamlined adaptation of an in-person Shared Decision-Making intervention.
16089652|NCT02239354|Device|VC-01™ Combination Product|Biologic and Device
16089653|NCT02239341|Other|Music Intervention|Music will be about 120 beats per minute and the participants will listen to the music while wearing head-phones in bed.
16089654|NCT02239341|Other|Muscle Conditioning Intervention|Music will be about 120 beats per minute and the participants will listen to the music while wearing head-phones and also participate in the muscle conditioning program while in bed.
16089655|NCT02239315|Other|Tumor RNA Disruption Assay™ (RDA)|Tumor RNA Disruption Assay™ (RDA) to generate RDA score from fine needle aspiration biopsy samples of breast cancer obtained 7-14 days after the first, second and third cycles of neoadjuvant chemotherapy; and, if there is a change of chemotherapy regimen, after the first cycle of the new chemotherapy.
16089656|NCT02239289|Other|Biofeedback|Idem as described in the arm section (above)
16089657|NCT02239276|Drug|Stiripentol|The initial dose of Stiripentol will be determined by the prescribing neurologist and titrated up to an initial goal dose of 50 mg/kg/day divided into 2 to 3 doses per day. Further dose increases by 10-20 mg/kg/day increments up to a max of 100 mg/kg/day or 4000 mg total daily dose may be necessary for improved seizure control.
16089658|NCT02239263|Device|Nucleus 6 Sound Processor|
16089693|NCT02238951|Other|No mHealth|Participants receive the same evidence-based care coordination without mHealth technology
16089659|NCT02239250|Device|Water filter and cookstove|"The Vestergaard Frandsen Lifestraw Family™ 2.1 is a point-of-use water treatment system.Water is poured through a 20 micron pre-filter into a 6L influent water tank.This water then filters through a 0.20 micron hollow-fiber ultrafiltration membrane into a 5.5L storage container.Water is then poured through a plastic tap, which prevents re-contamination.This system filters up to 18,000L of water.The system exceeds the WHO's highly protective standard for household water treatment technologies.The EcoZoom™ Spartan stove concentrates the combustion process while channeling airflow to completely burn the fuel provided.The stove has a ceramic combustion chamber within a steel housing, which is topped with a cast iron stove.The stove includes a rack for placing firewood and a pot skirt that improves the thermal efficiency.The cookstoves and filters will be delivered together at no cost to participating households.Households will receive instructions on how to operate these devices."
16089660|NCT02239237|Drug|Compound Kuh-seng Injection|Compound Kuh-seng Injection is a kind of natural compound injection extracted from Chinese herbs Kuh-seng (Radix Sophorae Flavescentis) and Rhizoma Heterosmilacis Japonicae. The major bioactive ingredients include oxymatrine，sophocarpidine, matrine, flavonoid etc.
16089661|NCT02239224|Biological|Placebo|Concentrate for solution for infusion
16089662|NCT02239224|Biological|ATYR1940|Concentrate for solution for infusion
16089663|NCT02239211|Drug|BTT1023|IV (in the vein) Investigational Medicinal Product (IMP)
16089664|NCT02239198|Other|Nutrition bar|The nutrition bar has been formulated to help achieve balanced nutrition with a polyphenolic-rich whole food matrix with vitamins, minerals, omega-3 fatty acids, and fiber at generally physiologic doses intended not to replace but to supplement a typical diet.
16089665|NCT02239185|Procedure|Hernial sac ligation in continuity|Laparoscopic closure of hernia sac at internal inguinal ring in continuity using 3 - 0 non-absorbable purse-string suture. The spermatic vessels and vas deferens are well visualized and protected during the suture. In all cases, hydro dissection can be done by injection of saline to separate the peritoneum from cord structures. Two 3-mm.needle holders are used for intracorporeal insertion of purse string suture around the opened IIR with intracorporeal knot tying. The stitches included the peritoneum and the underlying muscular tissue lateral to the spermatic cord. The procedure is modified in children with a dilated internal ring.
16089666|NCT02239185|Procedure|Hernial sac disconnection|Circumferential incision on the peritoneum at IIR will be started to separate hernia sac from the peritoneum. Initial disconnection of the vas and vessels will be done and then the peritoneum posterior to the internal ring will be divided and then the anterior disconnection will be carried out. Saline can be injected to separate the peritoneum from cord structures (hydro dissection). Care is taken not to damage the vas and vessels by handling them. Then the proximal part of the sac will be sutured using non-absorbable 3-0 prolene on round body needle.
16089667|NCT02239172|Biological|PA83-FhCMB|
16089668|NCT02239159|Other|TES(transcutaneous electric stimulation)|Stimulation will be given through electrodes attached to the skin
16089669|NCT02239146|Drug|catridecacog|Single doses of rFXIII administered intravenously (i.v.) to eight subjects in each of the four dose groups (11.9, 25, 35 and 50 IU/kg).
16089670|NCT02239146|Drug|placebo|Single doses of placebo administered intravenously (i.v.) to two subjects in each of the four dose groups (11.9, 25, 35 and 50 IU/kg).
16089671|NCT02239133|Device|ProVATE vaginal pessary|
16089672|NCT02239120|Drug|optional ASA as comedication|optional concomitant treatment which can be used for patients with coronary artery disease. It is not required for these pts.
16089673|NCT02239120|Drug|placebo to ASA|placebo to comparator drug
16089674|NCT02239120|Drug|placebo to optional ASA as comedication|optional concomitant treatment which can be used for patients with coronary artery disease. It is not required for these pts.
16089675|NCT02239120|Drug|placebo to dabigatran etexilate|placebo
16089676|NCT02239120|Drug|ASA 100 mg|active comparator drug
16089677|NCT02239120|Drug|dabigatran etexilate|active drug
16089678|NCT02239107|Drug|N-Acetyl cysteine|
16089679|NCT02239107|Procedure|laparoscopic ovarian drilling|
16089680|NCT02239094|Drug|Lurasidone (Latuda)|Antipsychotic medication approved for use with Bipolar disorder
16089681|NCT02239081|Drug|CTP-730|
16089682|NCT02239081|Drug|Placebo for CTP-730|
16089683|NCT02239042|Procedure|LLLT|The patients allocated for the test group received the following protocol for laser application: Five (5) points of irradiation were performed. The irradiation was performed with a ASGaAl diode laser that continuously emitted a wavelength of 660 nm. 30 mW was used for 20 seconds, and the total applied energy density (fluence) was 15 J/cm2 (3 J/cm2 per point and an application time of 4 seconds per point). The applications were performed using punctual contact (to reduce reflection) with the tip perpendicular to the gingival tissue. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was followed by seven more applications performed every other day, with a total of 8 laser applications. The power of the equipment was calibrated prior to each application. The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue
16089684|NCT02239029|Drug|platelet rich plasma|Platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders.
16089685|NCT02239029|Drug|Normal saline|The normal salin as the placebo intervention was injection in the other side of knee.
16089686|NCT02239003|Drug|DAOIB|
16089687|NCT02239003|Drug|Placebo|
16089688|NCT02238977|Drug|Fluoxetine|Antidepressant
16089689|NCT02238977|Drug|Bupropion|Antidepressant
16089690|NCT02238964|Device|Strattice™ Reconstructive Tissue Matrix|The protocol preference is for the mesh to be placed intra-peritoneally fashion (i.e. below the peritoneum). Anchoring bites will be taken in four to six sites of peritoneum (e.g. using 2-0 PDS) and the mesh will be 'parachuted' into place. Once correctly placed, the fascia above will be closed using Prolene, PDS or Nylon (surgeon preference, but excluding Vicryl). Infiltration of up to 40ml 0.25% Marcaine for infiltration into the fascial layer is recommended. The remainder of the closure will be at the surgeon's discretion.
16089691|NCT02238964|Procedure|Standard Closure|The non-intervention arm for fascial closure will be the preferred technique of the surgeon without mesh reinforcement. The fascia should be closed with Prolene, PDS or nylon sutures; Vicryl should not be used for the fascia. The remainder of the closure will be at the surgeon's discretion.
16089740|NCT02238548|Other|Raw milk|
16089694|NCT02238938|Procedure|en-bloc resection|En- bloc resection after marking by use of different customary endoscopic knifes including combining devices as hybrid knife to cut down the lesion. After submucosal injection of liquid (saline or equivalent) to elevate the tissue it will be dissected and removed by a snare of adequate size solitarily.
16089695|NCT02238938|Procedure|piecemeal resection|"Piecemeal resection is done by snare after marking and submucosal injection of saline or equivalent liquids. Small leftover adenoma tissue will be resected thoroughly by snare or forceps.
~After three months, an APC therapy will follow any piecemeal resection, if necessary, another resection of leftover adenoma will be done."
16089696|NCT02238925|Drug|CPX-351|
16089697|NCT02238912|Drug|kandhaga rasayanam|KANDHAGA RASAYANAM is a siddha herbo mineral drug with sulphur as a sole mineral ingredient. It is chosen from the classic Siddha text Siddha Vaidhya Thirattu.
16089698|NCT02238886|Dietary Supplement|Parenteral nutrition. SMOFKABIVEN infusion in central vene. Fresenius Kabi|
16089699|NCT02238873|Drug|Pegfilgrastim|
16089700|NCT02238860|Drug|Entacavir|Entacavir-0.5 mg ,OD,for
16089701|NCT02238860|Drug|Tenofovir|Tenofovir ,300 mg,OD,for 48 weeks
16089702|NCT02238847|Device|WallFlex™ Biliary RX Fully Covered/Uncovered Stent System|Reintervention can occur in Arm 1 or Arm 2 with either a WallFlex™ Biliary RX Fully Covered or Uncovered Stent System
16089703|NCT02238834|Drug|FP-025|Subjects will receive single doses of 200 to up to 800 mg of FP-025 (API-in-capsule) in a dose escalation format (cohorts 1-3). Subjects will receive single doses of 50 to up to 450 mg of FP-025 (ASD-in-capsule) in a dose escalation format (cohorts 4-8).
16089704|NCT02238834|Drug|Placebo|Subjects will receive single doses of FP-025 matching placebo (capsule) in a dose escalation format.
16089705|NCT02238834|Drug|FP-025|Subjects will receive doses of FP-025 (capsule) twice daily for 5 days.
16089706|NCT02238834|Drug|Placebo|Subjects will receive FP-025 matching placebo (capsule) twice daily for 5 days
16089707|NCT02238808|Drug|Estradiol|Eligible participants will take 2 mg Estradiol 3 times daily for 7-14 days pre-surgery.
16089708|NCT02238782|Drug|selumetinib 75mg single dose|3 capsules of 25 mg given as a single dose
16089709|NCT02238782|Other|[14C] selumetinib IV solution|single, radiolabeled, IV (infused), microdose (80 μg) of [14C] selumetinib, infused using a syringe pump as a 15-minute infusion, administered 1h 15 min after receiving the oral dose
16089710|NCT02238769|Device|18F-FluoroethylCholine PET|18F-FluoroethylCholine PET will be performed before any treatment of patients. 18F-FECH was prepared and provided by Nuclear Medical Center of our hospital.PET scan was performed using SIEMENS/CTI（index） EXACT HR（high resolution) +.
16089711|NCT02238756|Biological|CV8102|Subjects will receive 2 intramuscular doses of CV8102 given 21 days apart
16089712|NCT02238756|Biological|Rabipur|Subjects will receive 2 intramuscular doses of Rabipur given 21 days apart
16089713|NCT02238756|Biological|CV8102 + Rabipur|Subjects will receive 2 intramuscular doses of CV8102+Rabipur given 21 days apart
16089714|NCT02238730|Device|Ultrabrief Right Unilateral|The first six electroconvulsive therapy sessions using ultrabrief (0.25 ms) right unilateral electroconvulsive therapy
16089715|NCT02238730|Device|Brief Pulse Bitemporal|The first six electroconvulsive therapy sessions using brief pulse (0.5 ms) bitemporal electroconvulsive therapy
16089716|NCT02238717|Drug|PF-06372865 (65mg)|single oral dose (65 mg)
16089717|NCT02238717|Drug|PF-06372865 (15mg)|single oral dose (15mg)
16089718|NCT02238717|Drug|Pregabalin|single oral dose (300mg)
16089719|NCT02238717|Drug|Placebo|matching oral placebo
16089720|NCT02238704|Dietary Supplement|Regimen A calcium and iron/folic acid|Comparison of recommended administration schedule for calcium and iron/folic acid supplements in pregnant women
16089721|NCT02238704|Dietary Supplement|Regimen B calcium and iron/folic acid|Comparison of recommended administration schedule for calcium and iron/folic acid supplements in pregnant women
16089722|NCT02238691|Procedure|Mask ventilation with PEEP via a face mask device|"15 subjects will undergo anesthetic induction with an application of PEEP of 10 cm H2O during mask ventilation via a face mask.
~15 subjects will undergo anesthetic induction without PEEP during mask ventilation via a face mask."
16089723|NCT02238665|Device|Endomicroscopy|
16089724|NCT02238652|Behavioral|Communication|A preparation process before the patient become incapable of participating in life prolonging decisions
16089725|NCT02238652|Behavioral|Systematic Pain Assessment and Treatment|Assess pain with MOBID-2 Pain Scale and thereby improve pain management in dementia.
16089726|NCT02238652|Behavioral|Medication Review|An individual and systematic review of medication prescriptions to identify possible harmful drug effects and to reduce the use of psychotropic drugs.
16089727|NCT02238652|Behavioral|Occupational therapy|Increase individual activities, based on function, personal interest and personality by educating the staff on these elements.
16089728|NCT02238652|Behavioral|Safety|Focusing on developing a culture where staff has an active and constant awareness of how to prevent adverse events and a commitment to safety.
16089729|NCT02238639|Procedure|Diagnostic and therapeutic strategy: Highly sensitive D-dimer testing and, if positive, multidetector computed tomographic pulmonary angiography (MDCT).|"If MDCT is positive for pulmonary embolism, patients will receive anticoagulant treatment according to updated guidelines.
~If MDCT is negative for pulmonary embolism, patients will receive standard management for their exacerbation."
16089730|NCT02238626|Drug|Placebo (for MN-166)|
16089731|NCT02238626|Drug|MN-166|
16089732|NCT02238626|Drug|riluzole|Patient is given 50 mg riluzole twice daily.
16089733|NCT02238613|Device|radioactive stent|radioactive stent carrying seed iodine 125
16089734|NCT02238613|Device|plastic stent|common plastic stent without carrying seed iodine 125
16089735|NCT02238587|Other|Control group|In control group, only placebos are given for 6 weeks. The patients who are in control groups are switched to receive Ganoderma Spores Powder Capsules for 6 weeks.
16089736|NCT02238587|Dietary Supplement|Ganoderma Spores Powder Capsules|In experimental group, Ganoderma Spores Powder Capsules for 12 weeks.
16089737|NCT02238574|Procedure|surgery|excision or carbondioxide laser evaporation of the mucosal lesion of the oral cavity
16089738|NCT02238574|Other|follow up|Intensified outpatient follow up (16 visits in 5 years)
16089739|NCT02238548|Biological|Cholera vaccination|Oral cholera vaccination on day 0 and day 14
16089744|NCT02238509|Drug|Lapatinib|ARM A: oral lapatinib 1,000 mg daily in combination with intravenous trastuzumab 6mg/kg q3wks (after the initial 8 mg/kg loading dose).
16089745|NCT02238509|Drug|Trastuzumab|ARM A: oral lapatinib 1,000 mg daily in combination with intravenous trastuzumab 6mg/kg q3wks (after the initial 8 mg/kg loading dose).
16089746|NCT02238496|Procedure|Cytoreductive surgery|Standard of care/routine cytoreductive glioma resection surgery. Arm B only.
16089747|NCT02238496|Drug|Perifosine|Perifosine is a pill that has not been approved by the FDA which blocks a messenger that tells cancer cells to grow.
16089748|NCT02238496|Drug|Temsirolimus|Temsirolimus is an intravenous drug approved by the FDA for treatment of other cancers (kidney cancer, certain types of lymphoma) but not for brain tumors.
16089749|NCT02238483|Drug|AZD7624 1.0 mg|Inhaled AZD7624 solution, 11 mg/mL
16089750|NCT02238483|Drug|Placebo|Inhaled placebo solution
16089751|NCT02238470|Drug|oral anticoagulants|Comparison of patients receiving oral anticoagulants with or without microbleeds in magnetic resonance imaging
16089752|NCT02238457|Drug|Low dose losartan|25 mg losartan bid for 10 weeks
16089753|NCT02238457|Drug|High dose losartan|50 mg, 75 mg, or 100 mg bid for 10 weeks. Dose will be determined by the medical doctor depending on patients' tolerability
16089754|NCT02238444|Drug|Warfarin|From postoperative day 3, patients will receive oral Warfarin 2.5mg qd with titration of dose to maintain a target INR of 2-3 for 1 year.
16089755|NCT02238444|Drug|Dipyridamole|From postoperative day 3, patients will receive oral dipyridamole 25mg tid for three months.
16089756|NCT02238444|Drug|Aspirin|From postoperative day 3, patients will receive oral Aspirin Enterie Ccoated Tablets 100mg qd for 1 year.
16089757|NCT02238444|Drug|Low Molecular Weight Heparin|From postoperative day 3, Patients will receive subcutaneous injection of Low Molecular Weight Heparin (4100 IU) once daily for first five days.
16089758|NCT02238431|Drug|Lucrin depot|scheduling the start of the artificial cycle and hormone down regulation during the artificial cycle
16089759|NCT02238431|Drug|OCP|to schedule the start of the artificial cycle
16089760|NCT02238431|Other|Natural|to use the normal menstrual period to schedule treatment start
16089761|NCT02238418|Drug|Cholecalciferol vial (100 000 UI)|"VISIT 1:
~Patient > 60 kg and initial 25OHD serum concentration < 25nmol/L : prescription of 4 vials to be taken every 2 weeks between 25 and 50 nmol/L: prescription of 3 vials to be taken every 2 weeks between 50 and 75 nmol/L: prescription of 2 vials to be taken every 2 weeks Patient between 20 and 60 kg and initial 25OHD serum concentration < 25nmol/L: prescription of 2 vials to be taken every month between 25 and 50 nmol/L: prescription of 2 vials to be taken every 6 weeks between 50 and 75 nmol/L: prescription of 1 single vial Patient < 20 kg and initial 25OHD serum concentration < 75 nmol/L: prescription of 1 single vial
~A local lab will performed urinary dosage of calciuria and creatininuria:
~at days 0, 1, 2, 3, 4 and 7 after the first intake of a 25OHD vial
~at days 0, 2 and 4 after other intakes (when applicable)
~VISIT 2:
~25OHD serum concentration will then be dosed at month 2 after visit 1"
16089762|NCT02238405|Other|Intensive anti-smoking counseling|Study participants randomized to the intervention arm will receive intensive cessation support outside of the TB clinic setting, from a health worker trained in cessation counseling, during the course of their TB treatment. Behavioral elements will consist of follow up using unscheduled drop in or phone sessions, motivational interviewing, and counseling tailored to the needs and circumstances of the patient. Patients who are current smokers and are ready to commit to quit smoking will be supported to stop completely. Recent smokers will supported for having quit, and the counselor will discuss coping strategies to maintain abstinence.
16089763|NCT02238392|Procedure|Adenosine test|Testing dormant conduction after PVI
16089764|NCT02238392|Procedure|Termination of AF|Testing AF iducibility and ermination of
16089765|NCT02238379|Drug|Oxytocin|24 International Units of Oxytocin in a Nasal Spray
16089766|NCT02238379|Other|Placebo|Placebo will contain all ingredients except the active oxytocin in the Nasal Spray.
16089767|NCT02238366|Drug|triptorelin|This is an observational study. Thus, the treatment selection with triptorelin (Diphereline® or Diphereline PR®) is at investigator's discretion based on the current practice principles and guidelines/protocols, in accordance with the Summary of Product Characteristics (SmPC) approved in Romania by the National Medicines Agency.
16089768|NCT02238353|Drug|azelastine + fluticasone|
16089769|NCT02238353|Drug|Placebo|
16089770|NCT02238340|Drug|Extended-release oxycodone|10 o 20 mgrs of extended-release oxycodone ,started 12 hours before orthopaedic surgery
16089771|NCT02238340|Drug|Extended- release Oxycodone|
16089772|NCT02238340|Drug|ketoprofen|
16089773|NCT02238340|Drug|dipirone|
16089774|NCT02238340|Drug|dexametasone|
16089775|NCT02238340|Drug|Morphine IV (rescue)|
16089776|NCT02238327|Procedure|blood draw|Blood will be drawn for plasma, serum, and PBMCs. Clinical labs drawn will be for hepatitis, CMV, hemoglobin and carboxyhemoglobin.
16089777|NCT02238327|Procedure|questionnaires|The following questionnaires are administered to participants by study personnel at each visit: LEAP questionnaire, St. George's, and MMRC.
16089778|NCT02238327|Procedure|Lung function testing|The routine lung function endpoints of FVC, FEV1, FEV1/FVC, and FEF25-75% will be measured before and after bronchodilator administration (4 puffs of albuterol). The best of three reproducible forced expiratory attempts is used in analysis. Percent- predicted spirometric values are based on age, height, gender, and ethnicity. DLco will be measured using the automated single-breath procedure of the integrated testing system, which conforms to ATS standards. DLco will be adjusted for hemoglobin and carboxyhemoglobin.
16089779|NCT02238327|Procedure|Six-Minute walk test|Six-minute walk tests are performed in a 100 foot (30.48 m) segment of straight hallway marked at 10 foot (3 m) intervals. In addition to the usual ATS protocol, the patient is monitored, when available, with Bluetooth wireless pulse oximetry and the time and distance recorded after six minutes and if they desaturate to <88%. Dyspnea (Borg 0-10) and perceived exertion (Borg 6-20) scales are completed at the beginning and the end of test.
16089844|NCT02237911|Other|Clinic-based outpatient exercise group|Subjects will participate in supervised sessions (clinic-based) of exercise followed by a home exercise program 2 times per week during 3 months. Each exercise session will last about 60 minutes. Treatment sessions will utilize a pragmatic approach and will include the exercises designed to increase muscular strength, low impact cardiovascular exercise, range of movement, and activity for daily living skills.
16089780|NCT02238327|Radiation|Quantitative CT scans|Subjects will undergo a standard chest CT. The CT scans will use a phantom shipped between sites to standardize results and capture contiguous volume scans acquired at slice thicknesses of 5.0 mm in the axial plane and reconstructed with 512 x 512 pixel matrices. CT examinations will encompass the entire thorax and be performed during a breath-hold at end-inspiration. We will measure % of lung tissue below a threshold for emphysema (i.e. -950 Hounsfield units). Measurements have been histologically-verified and give reproducible measurements. The data set is assembled and analyzed with the image data anonymized.
16089781|NCT02238327|Procedure|Nasal secretion and cell collection|Participants will be instructed to blow their nose to remove accumulated mucus. Two sprays of commercially available nasal saline will be instilled in each nostril. The participant will then be ask to exhale through the rinsed nostril into a specimen cup. We will repeat this up to 5 times on each side depending on the participants' tolerance to the procedure. Using an otoscope, a small curette will then be used to collect 3 to 5 samples of nasal cells from each nostril. These samples will be used immediately for analysis or banked for future study.
16089782|NCT02238327|Procedure|Echocardiogram|The cardiac ultrasound will use standard ultrasound techniques to image two-dimensional slices of the heart using 3D real-time imaging.
16089783|NCT02238314|Drug|Tipranavir low dose|
16089784|NCT02238314|Drug|Tipranavir high dose|
16089785|NCT02238314|Drug|Ritonavir|
16089786|NCT02238314|Drug|Nucleoside Reverse Transcriptase Inhibitor (NRTI)|
16089787|NCT02238314|Drug|Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)|
16089788|NCT02238301|Other|Bold sequence patients test|Develop the hyperventilation protocol (speed, duration ...) and the choice of type of mask oxygenation better tolerated by patients. Sequences beginning with a low oxygen flow (2L/mn) then progressively increasing to obtain the BOLD effect required
16089789|NCT02238301|Other|Bold + ASL sequence|"A first sequence BOLD+ASL will be launched in ambient air. The second sequence is repeated BOLD 5 minutes after power maternal hyperventilation.
~Sequences will focus on the fetus and placenta but will also include maternal liver to validate maternal hyperoxygenation."
16089790|NCT02238288|Drug|Aminocaproic acid|Crushed tablet in the dental socket
16089791|NCT02238288|Other|Routine dental care|Chompret´s manoeuver, suture, surgical wound compression with gauze for 20 minutes
16089792|NCT02238288|Drug|lidocaine and epinephrine|2%
16089793|NCT02238288|Drug|Paracetamol|750 mg
16089794|NCT02238275|Drug|Micardis® plus|
16089795|NCT02238262|Drug|Telmisartan|
16089796|NCT02238249|Drug|Alesion®|Dry Syrup
16089797|NCT02238236|Drug|Alesion®|Dry Syrup
16089798|NCT02238223|Drug|Alesion®|
16089799|NCT02238210|Drug|Atrovent®|
16089800|NCT02238197|Drug|Atrovent® Inhalation Solution|
16089801|NCT02238184|Drug|Atrovent®|
16089802|NCT02238184|Drug|Ventilat®|
16089803|NCT02238171|Drug|Atrovent® inhalets|
16089804|NCT02238158|Drug|Atrovent® inhalets|
16089805|NCT02238145|Drug|Atrovent® Inhaletten|
16089806|NCT02238132|Drug|ATROVENT® inhalets|
16089807|NCT02238119|Drug|Tiotropium + formoterol combination|
16089808|NCT02238119|Drug|Tiotropium|
16089809|NCT02238119|Drug|Formoterol|
16089810|NCT02238106|Drug|Salmeterol medium dose|
16089811|NCT02238106|Drug|Salmeterol low dose|
16089812|NCT02238106|Drug|Salmeterol high dose|
16089813|NCT02238106|Drug|Serevent® Diskus®|
16089814|NCT02238106|Drug|Placebo HandiHaler®|
16089815|NCT02238106|Drug|Placebo Diskus®|
16089816|NCT02238080|Drug|Methoxy Polyethylene Glycol-Epoetin Beta|Methoxy polyethylene glycol-epoetin beta will be administered according to the usual standard of care and current best practice guidelines and will be observed during the study period.
16089817|NCT02238067|Drug|ESA|Participants will continue to receive their ESA treatment, as per physician's discretion. The study protocol does not specify any particular ESA drug.
16089818|NCT02238067|Other|Satisfaction Survey Questionnaire|Each participant will be interviewed to complete treatment satisfaction questionnaire survey at baseline and at 6-month follow-up visit.
16089819|NCT02238041|Device|GlucoClear System|
16089820|NCT02238028|Behavioral|Wear respirator|Healthy adult subjects wore the particulate filtering respirators for continuous 48 hours as much as possible both indoor and outdoor.
16089821|NCT02238015|Procedure|cataract surgery|All patients underwent cataract surgery with 3.0 mm clear corneal incision at 11 o'clock in one eye
16089822|NCT02238002|Procedure|cataract surgery|The patients of both groups underwent cataract surgery
16089823|NCT02237989|Drug|paracetamol|1500 mg
16089824|NCT02237989|Drug|paracetamol+native collagen type 2|paracetamol (1500 mg) + native collagen type 2 (10mg)
16089825|NCT02237976|Behavioral|Self-hypnosis|
16089826|NCT02237976|Behavioral|Routine practice|
16089827|NCT02237963|Procedure|Posterolateral thoracotomy|
16089828|NCT02237963|Procedure|Axillary thoracotomy|
16089829|NCT02237950|Drug|Metronidazole oral tablets 500mg|One tablet taken orally twice daily for seven consecutive days
16089830|NCT02237950|Drug|1% SPL7013 Gel|5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.
16089831|NCT02237950|Drug|Placebo gel|5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks
16089832|NCT02237937|Drug|Paroxetine|
16089833|NCT02237937|Drug|Sertraline|
16089834|NCT02237937|Drug|Citalopram|
16089835|NCT02237937|Drug|Venlafaxine|
16089836|NCT02237937|Drug|Amitriptyline|
16089837|NCT02237937|Drug|Escitalopram|
16089838|NCT02237937|Drug|Amitriptylinoxide|
16089839|NCT02237937|Drug|Nortriptyline|
16089840|NCT02237937|Drug|Trimipramine|
16089841|NCT02237924|Drug|endostar|Endostar 7.5mg / m2, 2 cycles of intravenous infusion for ten days,and 2 cycles of maintenance therapy after radiotherapy
16089842|NCT02237924|Drug|DDP|DDP:80mg/m2 for 2-3 cycles
16089843|NCT02237924|Radiation|IMRT|IMRT:70-74Gy for 2-3 cycles
16089881|NCT02237560|Behavioral|Cybercyle-Tour|Exercising on virtual-reality enhanced stationary recumbent bicycle and pedaling through interactive 3D scenic bike tours for 6 months, 3-5x/week.
16089845|NCT02237911|Other|Community-based exercise group|Subjects will attend to exercise classes (community-based) 2 times per week during 3 months. The exercise classes last approximately 60 minutes. The group exercise classes consists of a variety of exercises designed to increase general muscular strength, low impact aerobic exercise, range of movement, and activity for daily living.
16089846|NCT02237898|Behavioral|MoMba Live Long app & Sensordrone™ carbon-monoxide sensor|MoMba Live Long application & Sensordrone™ carbon-monoxide sensor to deliver contingency management remotely
16089847|NCT02237898|Behavioral|Office contingency management|A control group which will receive financial incentives at an in-person office/clinic visit based on expired CO levels obtained through the piCO sensor.
16089848|NCT02237898|Device|Sensordrone™ carbon-monoxide sensor|A custom breath CO meter built by Sensorcon Inc. (Sensordrone, part No. SDRONEG1) that uses an electrochemical CO gas sensor to measure environmental CO. The Sensordrone is accurate to within 10% with a resolution of 1 parts per million (ppm). The Sensordrone pairs via Bluetooth with the MoMba Live Long application.
16089849|NCT02237898|Device|MoMba Live Long Smartphone application|The MoMba Live Long app provides an interface for the Sensordrone which allows participants to complete a breath test and see results of smoking status. The app verifies the user is correctly taking the tests by recording pictures using the front facing camera as well as recording audio to verify that the participants where exhaling while taking the test. The app also provided a platform for social interaction based on a previous system where app users can interact with each other and provide support during the quitting process.
16089850|NCT02237885|Device|NeuroSky MindWave Mobile|
16089851|NCT02237859|Drug|Vancomycin|Vancomycin Group: Study participants started on a broad-spectrum antibiotic will be initiated on Vancomycin 125 mg PO QD within 48 hrs of the 1st dose of primary broad-spectrum antibiotic and continued to complete a 10 day course regardless of the duration of primary antibiotic. Dose of oral Vancomycin is 125 mg PO QD. Vancomycin liquid will be dissolved in fruit juice which is standard practice at Spectrum Health Hospitals. Both groups will continue in the study even if their broad spectrum antibiotic therapy is curtailed prior to 10 days.
16089852|NCT02237859|Dietary Supplement|fruit juice/placebo|Placebo Group: Will receive similar volume of fruit juice/placebo for 10 days.
16089853|NCT02237846|Biological|Human umbilical cord tissue-derived mesenchymal stem cells|
16089854|NCT02237820|Drug|Dexamethasone|6 mg/day of Oral Dexamethasone
16089855|NCT02237820|Drug|Prednisone|40 mg/day of Oral Prednisone
16089856|NCT02237807|Drug|DIRITHROMYCIN 500 MG ENTERIC COATED TABLET|
16089857|NCT02237807|Drug|DYNABAC 250 MG ENTERIC COATED TABLET|
16089858|NCT02237781|Drug|Gonadotropins|The dose of gonadotropins either in the form of a combination of highly purified urinary FSH and LH or with a combination of Rec FSH and Rec LH will depend on the levels of E2 and FSH prior to ovarian stimulation .
16089859|NCT02237768|Drug|DIRITHROMYCIN 500 MG ENTERIC COATED TABLET|
16089860|NCT02237768|Drug|DYNABAC 250 MG ENTERIC COATED TABLET|
16089861|NCT02237755|Drug|Clomiphene citrate|clomiphene citrate 100mg/day will be added to the standard gonadotropin regiment
16089862|NCT02237755|Drug|Gonadotropins|All patients will be stimulated with a fixed GnRH-antagonist protocol. Ovarian stimulation will be initiated with 450 IU of gonadotropins either in the form of a combination of highly purified urinary FSH and LH or with a combination of Rec FSH and Rec LH.
16089863|NCT02237742|Drug|PF-06427878|Intravenous, 100 micrograms, single dose, 30 minute infusion
16089864|NCT02237729|Biological|PF-06410293|PF-06410293 will be administered as a single 40 mg, subcutaneous dose
16089865|NCT02237729|Biological|Adalimumab-US|Adalimumab-US will be administered as a single 40 mg, subcutaneous dose
16089866|NCT02237729|Biological|Adalimumab-EU|Adalimumab-EU will be administered as a single 40 mg, subcutaneous dose
16089867|NCT02237703|Other|Positron emission tomography (PET) imaging|Positron emission tomography (PET) imaging
16089868|NCT02237690|Drug|Doxorubicin hydrochloride liposome|50mg/m2,IV on day1 of each cycle,On Day 1 of Cycle 2, patients will crossover to the alternate reference or test formulation,After completion of Cycle 2 (Day 28), patients will be continued on the treatment of Doxorubicin Hydrochloride Liposome Injection up to 4 more cycles if tolerance permits under guidance of their attending physicians.
16089869|NCT02237677|Other|Positron emission tomography (PET) imaging|Positron emission tomography (PET) imaging
16089870|NCT02237664|Procedure|Continuous paravertebral analgesia (C-PVB)|Patients will receive continuous paravertebral infusion of bupivacaine 0.2% and fentanyl 2 μg mL-1 at rate of 8 mL h-1
16089871|NCT02237664|Procedure|Patient-controlled paravertebral analgesia (PC-PVB)|Patients will receive background continuous paravertebral infusion of bupivacaine 0.2% and fentanyl 2 μg mL-1 at rate of 8 mL h-1 with patient demand bolus dose of 3 mL and lockout time of 15 min with a 20 mL h-1 maximum dose, irrespective of their age
16089872|NCT02237651|Device|topical anesthesia multi-use device|
16089873|NCT02237651|Device|topical anesthesia Intranasal Mucosal Atomization|
16089874|NCT02237638|Biological|hVEGF26-104/RFASE|Three intramuscular injections on days 0, 14 and 28, followed by an observational period of 6 weeks. If hererafter VEGF is not (or no longer) neutralized in serum and there is no sign of disease progression, another booster vaccination can be given. This booster can be repeated until disease progression, death or withdrawal from the study.
16089875|NCT02237612|Procedure|diffusion-weighted magnetic resonance imaging|Undergo diffusion-weighted MRI
16089876|NCT02237612|Other|laboratory biomarker analysis|Correlative studies
16089877|NCT02237586|Biological|PfSPZ Challenge|live, aseptic, cryopreserved P. falciparum sporozoites
16089878|NCT02237573|Other|Written medical report and standardized medical advices|"The intervention will include: 1) handing the patient at the end of the consultation a copy of the consultation report which will be composed of:
~a detailed report of the consultation (motive, case history, clinical examination, conclusion)
~written standardized medical advices from evidence published in the literature. Interventions will be designed by several general practitioners and tested by few patients."
16089879|NCT02237573|Other|Control|"Other:
~Oral standardized medical advices from evidence published in the literature. Physicians will be trained by a single investigator."
16089880|NCT02237560|Behavioral|Cybercycle-Game|Exercising on a virtual-reality enhanced stationary recumbent bicycle while playing interactive 3D video-game for 6 months, 3-5x/week.
16090022|NCT02236598|Drug|Placebo|
16089882|NCT02237560|Behavioral|Game Only|While seated on a stationary recumbent seat play interactive 3D video-game for 6 months, 3-5x/week (no pedaling).
16089883|NCT02237547|Biological|Intravenous and intrathecal human umbilical cord tissue-derived mesenchymal stem cells and bone marrow mononuclear cells|
16089884|NCT02237534|Drug|Lanthanum carbonate|
16089885|NCT02237534|Drug|Calcium Carbonate|
16089886|NCT02237521|Other|Eu- and hyperglycemic clamp|Eu- and hyperglycemic clamp with concomitant infusion of the natural occurring hormones glucagon-like peptide-1 (GLP-1), glucose-dependent insulinotropic peptide (GIP) or placebo along with stable glucose isotope infusion to measure the effects of the incretins.
16089887|NCT02237521|Other|Arginine test|Bolus infusion of the natural occurring amino acid arginine to measure the ability to increase the secretion of insulin and glucagon
16089888|NCT02237508|Drug|Z7200|
16089889|NCT02237508|Drug|Symbicort Turbohaler|
16089890|NCT02237508|Drug|Z7200 with charcoal|
16089891|NCT02237508|Drug|Symbicort Turbohaler with charcoal|
16089892|NCT02237508|Drug|Symbicort Turbohaler replicate|
16089893|NCT02237495|Drug|dexmedetomidine|dexmedetomidine with the dose of 0.4 ug/kg/h is continuously infused right after anesthesia induction and lasts for 12 hrs.
16089894|NCT02237495|Drug|placebo|The vehicle of dexmedetomidine, normal saline is continuously infused right after anesthesia induction and lasts for 12 hrs with the same rate of the treatment arm.
16089895|NCT02237482|Device|Trilogy cup|
16089896|NCT02237482|Device|Trabecular metal cup (TM)|
16089897|NCT02237482|Device|ZCA cup|
16089898|NCT02237469|Radiation|Prone and supine simulation|Treatment planning in the two positions.
16089899|NCT02237456|Procedure|Comparison of OCT scans|
16089900|NCT02237456|Procedure|Comparison of Intra Vascular Optical Coherence Tomography Systems for Assessment of Coronary Tissue, Stents and Scaffolds - DOCTOR Compare|
16089901|NCT02237443|Drug|Rocuronium|Administration of a NMBD
16089902|NCT02237443|Drug|Vecuronium Bromide|Administration of a NMBD
16089903|NCT02237443|Drug|Succinylcholine|Administration of a NMBD
16089904|NCT02237430|Device|MynxGrip|Closure device for femoral artery access closure
16089905|NCT02237430|Other|Manual compression|Conventional manual compression
16089906|NCT02237417|Drug|Standard of Care Oral antipsychotics|A total of 15 to 20 subjects with schizophrenia will receive SOC oral antipsychotic medications (e.g., aripiprazole (Abilify®), risperidone (Risperdal®), lurasidone HCI (Latuda®), quetiapine fumarate (Seroquel®), olanzapine (Zyprexa®), and ziprasidone HCI(Geodon®)) or once monthly aripiprazole (Abilify®), PO daily, in accordance with their respective product labeling.
16089907|NCT02237417|Drug|IM aripiprazole once monthly|A total of 30 to 40 subjects with schizophrenia will receive aripiprazole (Abilify®) monthly, at a starting dose of 400 mg IM or an approved dose based on the investigator's judgment and in accordance with product labeling.
16089908|NCT02237417|Other|No Treatment|A total of 15 healthy controls will participate in the study and will not receive medication
16089909|NCT02237404|Device|Telemedicine System|Telemedicine System is used in remote monitoring group
16089910|NCT02237391|Other|CIPAP Program|The intervention will involve a pain specialist, a clinical health psychologist and a nurse. As needed, it may involve a social worker, an addiction specialist, and other specialists. The pain specialist will conduct an evaluation that includes: history of presenting illness, review of systems, review of pain treatments, medical history, surgical history, addiction history, medications and allergies, insurance for medication, psychosocial history, opioid risk assessment, physical examination, and review of tests and investigations. The psychologist will conduct an evaluation that includes: a structured diagnostic clinical interview, a review of coping strategies, and a review of the questionnaires completed prior to the assessment pertaining to mood, anxiety, trauma and beliefs about pain.
16089911|NCT02237391|Other|Treatment as Usual (TAU)|Control group
16089912|NCT02237378|Radiation|FDG PET scan|Following an overnight fast, subjects will be positioned in the Discovery 660 PET/VCT scanner. Following a scout scan to confirm patient positioning, low dose xray CT scan is performed for photon attenuation. A 20 minute dynamic PET scan is started simultaneously with 3 MBq/kg of N-13 ammonia to measure myocardial perfusion. Following N-13 decay,a 60 minute dynamic PET scan with 3 MBq/kg F-18- FDG to measure myocardial glucose uptake. Blood sampling for glucose and insulin will occur at pre specified time points throughout the scan.
16089913|NCT02237365|Drug|81mg aspirin|1 tablet of 81mg aspirin and 2 tablets of placebo (visually matched to 500mg aspirin) daily for 60 days
16089914|NCT02237365|Drug|1000mg aspirin|1 tablet of 81mg placebo (visually matched to 81mg aspirin) and 2 tablets of 500mg aspirin daily for 60 days
16089915|NCT02237365|Drug|Placebo|1 tablet of 81mg placebo (visually matched to 81mg aspirin) and 2 tablets of 500mg placebo (visually matched to 500mg aspirin) daily for 60 days
16089916|NCT02237339|Drug|Allopurinol|Uric acid lowering medication.
16089917|NCT02237339|Drug|Placebo|
16089918|NCT02237326|Procedure|Visual Inspection with Acetic Acid|Visual Inspection with Acetic Acid is the application of acetic acid to a cervix, followed by examination with a light source. It is not a new drug or device, and has been used in resource-limited settings for several decades. The purpose of this trial is to compare the two screening techniques, which had not been done previously.
16089919|NCT02237326|Procedure|Visual Inspection with Lugol's Iodine|Visual Inspection with Lugol's Iodine is the application of lugol's iodine to a woman's cervix, followed by examination with a light source with the goal of detecting precancerous lesions. Like Visual Inspection with Acetic Acid, it is not a new drug or device.
16089920|NCT02237313|Behavioral|psychological support and therapeutic education program|
16089921|NCT02237300|Behavioral|VR based cue-exposure therapy|Comparison of VR based cue-exposure therapy sessions and additional Cognitive-behavioral treatment sessions
16089922|NCT02237300|Behavioral|Additional Cognitive-behavioral treatment|Comparison of VR based cue-exposure therapy sessions and additional Cognitive-behavioral treatment sessions
16089923|NCT02237287|Other|wound dressing with VAC and sNAG without antiaggregation|
16089924|NCT02237287|Procedure|wound dressing with VAC|
16089925|NCT02237287|Drug|wound dressing with VAC and sNAG under Antiaggregation|
16089926|NCT02237274|Other|High altitude exposition|High altitude exposition
16090193|NCT02235402|Drug|Placebo|
16089927|NCT02237261|Drug|Bendamustine, Bortezomib, Prednisone|"Cycle 1 (d1-42) - Induction:
~Bortezomib: 1.3 mg/m2 s.c.: d1, 4, 8, 11, 22, 25, 29, 32 Bendamustine: 90 mg/m2 iv, d1, 2 Prednison: : 60 mg/m2 po,, d1-4
~Cycle 2-9 (d1-28) - Consolidation:
~Bortezomib: 1.3 mg/m2 s.c.: d1, 8, 15, 22 Bendamustine: 90 mg/m2 iv: d1, 2 Prednison: 60 mg/m2 po: d1-4"
16089928|NCT02237235|Drug|MMFS-202-302|"Active ingredient: L-Threonic acid Magnesium salt.
~1 g (2 pills) by mouth once daily in the evening for 9 weeks
~Drug: MMFS-302 Active ingredient: L-Threonic Acid Magnesium Salt
~1 g (2 pills) by mouth once daily in the morning for 9 weeks"
16089929|NCT02237235|Drug|Placebo|Two tablets by mouth in the morning, and two tablets by mouth in the evening, daily for 9 weeks.
16089930|NCT02237222|Other|Gait rehabilitation|
16089931|NCT02237209|Biological|RSV LID ΔM2-2 Vaccine|10^5.0 plaque forming units (PFU); 0.5 mL dose delivered as nose drops (approximately 0.25 mL per nostril)
16089932|NCT02237209|Biological|Placebo Vaccine|0.5 mL dose delivered as nose drops (approximately 0.25 mL per nostril)
16089933|NCT02237196|Biological|AMG 157|AMG 157 will be administered once every 4 weeks at dose of 700 mg intravenously. Each AMG 157 dose will be administered at least 1 day before immunotherapy through week 24, then on the same day as immunotherapy thereafter.
16089934|NCT02237196|Biological|Cat Immunotherapy|A standardized allergen extract licensed in the United States for allergen immunotherapy, and is formulated as a long-acting suspension for subcutaneous injection
16089935|NCT02237196|Biological|Cat Immunotherapy Placebo|Placebo for allergen-specific immunotherapy administered subcutaneously
16089936|NCT02237196|Biological|AMG 157 Placebo|Placebo for AMG 157 administered intravenously
16089937|NCT02237183|Drug|Iloprost|Given via inhalation
16089938|NCT02237183|Other|Placebo Administration|Given via inhalation
16089939|NCT02237183|Other|Quality-of-Life Assessment|Ancillary studies
16089940|NCT02237183|Other|Questionnaire Administration|Ancillary studies
16089941|NCT02237157|Drug|Gemcitabine, local delivery|Intra-arterial targeted drug delivery
16089942|NCT02237144|Other|Cash transfer|1500 taka ($18.75) per household distributed monthly
16089943|NCT02237144|Other|Food transfer|30 kg rice, 2 kg lentils, and 2 kg micro-nutrient fortified cooking oil per household distributed monthly
16089944|NCT02237144|Other|Food and cash transfer|15 kg of rice; 1 kg of lentils and 1 kg of micronutrient fortified cooking oil and 750 taka cash per household, distributed monthly
16089945|NCT02237144|Behavioral|Behavior Communication Change (BCC)|Weekly, one hour meetings on maternal and child nutrition, sanitation and health knowledge, attitudes and practice Occasional home visits
16089946|NCT02237131|Drug|Oral contraceptives cyclic|tables containing Ethinyl estradiol 0.03mg and drospirenone 3mg will be administered in a cyclic fashion 21 days on 7 days off pill for 6 cycles.
16089947|NCT02237131|Drug|Oral contraceptives continuous|Patients will be treated with oral contraceptives containing 0.03mg ethinyl estradiol and 3 mg drospirenone per day in a continuous fashion.
16089948|NCT02237118|Device|Mepitel One|
16089949|NCT02237118|Device|UrgoTul|
16089950|NCT02237105|Behavioral|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy
16089951|NCT02237092|Procedure|Measurement of IAP|The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, for 10 minutes, after quiet breathing pregnant at the time of expiration.
16089952|NCT02237079|Drug|Bazedoxifene/Conjugated Estrogens (BZA/CE)|Daily tablet containing conjugated estrogens 0.45 mg and bazedoxifene 20 mg.
16089953|NCT02237079|Drug|Placebo Oral Tablet|Daily placebo tablet
16089954|NCT02237066|Device|Chocolate PTA Balloon Angioplasty|OCT imaging of diseased vessel is treated with an Angioplasty Procedure using the Chocolate PTA Balloon Catheter followed by OCT imaging of the treated area immediately after balloon use and 10 minutes later
16089955|NCT02237066|Device|Standard PTA Balloon Angioplasty|OCT imaging of diseased vessel is treated with an Angioplasty Procedure using a standard PTA Balloon Catheter followed by OCT imaging of the treated area immediately after balloon use and 10 minutes later
16089956|NCT02237053|Drug|Glucagon|
16089957|NCT02237053|Drug|Octreotide|
16089958|NCT02237053|Behavioral|Placebo|
16089959|NCT02237053|Drug|Insulin|
16089960|NCT02237040|Procedure|Mandibular manipulation technique|patients are treated with The mandibular manipulation technique reported by Farrar, which was an effective treatment method to reset the physiological positional relationship between condyle and disc.Then patients are told to persist in mouth opening training at home everyday. The mouth opening training is performed as follow: patients are told to try to close his mouth in intercuspal position at first, then open their mouth as wide as possible(the reference maximal mouth opening is as wide as the mouth opening after treatment in last time), then close back to the intercuspal position again.
16089961|NCT02237027|Biological|TasP using ART regimen as per Benin guidelines|Administration of ART to HIV positive female sew workers in order to prevent HIV transmission.
16089962|NCT02237027|Biological|PrEP using Truvada|Administration of Truvada to HIV negative female sex workers in order to prevent HIV acquisition.
16089963|NCT02237001|Device|Suture-based meniscal repair|Suture-based meniscal repair
16089964|NCT02236988|Drug|Apremilast Immediate Release|30 mg immediate release tablets
16089965|NCT02236988|Drug|Apremilast Modified Release 1|75 mg oral tablet of prototype modified release (MR) 1
16089966|NCT02236988|Drug|Apremilast Modified Release 2|75 mg oral tablet of prototype MR 2
16089967|NCT02236988|Drug|Apremilast Modified Release 3|75 mg oral capsule of prototype MR 3
16089968|NCT02236988|Drug|Apremilast Modified Release 4|75 mg oral capsule of prototype MR 4
16089969|NCT02236988|Drug|Apremilast Modified Release 5|75 mg oral capsule of prototype MR 5
16089970|NCT02236988|Drug|Apremilast Modified Release 6|75 mg oral capsule of prototype MR 6
16089971|NCT02236988|Drug|Apremilast Modified Release 8|80 mg oral capsule of prototype MR 8
16089972|NCT02236988|Drug|Apremilast Modified Release 9|80 mg oral capsule of prototype MR 9
16089973|NCT02236988|Drug|Apremilast Modified Release 11|80 mg oral capsule of prototype MR 11
16089974|NCT02236988|Drug|Apremilast Modified Release 12|80 mg oral capsule of prototype MR 12
16089975|NCT02236988|Drug|Apremilast Modified Release 13|80 mg oral capsule of prototype MR 13
16089976|NCT02236988|Drug|Apremilast Modified Release 14|80 mg oral capsule of prototype MR 14
16089977|NCT02236975|Device|BuMA Supreme Biodegradable drug coating coronary stent system|
16089978|NCT02236975|Device|Resolute Integrity durable polymer stent system|
16089979|NCT02236962|Drug|Placebo|
16089980|NCT02236962|Drug|Ephedrine, pioglitazone|
16089981|NCT02236949|Behavioral|Pain Practice Change Booster Intervention|See experimental arm for a description of the intervention
16089982|NCT02236936|Dietary Supplement|Standard care of parenteral nutrition|Standard treatment according to the discretion of the center, any required nutritional support (enteral tube feeding by nasogastric tube or percutaneous endoscopic gastrostomy) when considered necessary is allowed
16089983|NCT02236936|Dietary Supplement|Parenteral over night nutrition|Patients in interventional Arm B will receive parenteral overnight nutrition with ZentroOLIMEL® 5.7% with electrolytes, vitamins (Cernevit®) and micronutrients (Addel Trace® or Nutryelt®) starting with 15 ml/kg body weight/day. In case of weight loss of more than 5%, dose of ZentroOLIMEL® has to be increased up to 25 ml/kg/body weight/day.
16089984|NCT02236936|Biological|Cetuximab|"Weekly during radiotherapy; not given if cisplatin is given during radiotherapy
~Cetuximab 400 mg/m2 (saturation) Cetuximab 250mg/m2 (during radiotherapy; in total 7x)"
16089985|NCT02236936|Drug|Cisplatin|Cisplatin total dose of >200 mg administered weekly (40 mg/m2/week) or every three weeks (100 mg/m2 every three weeks) according to local standard; not given in combination with cetuximab
16089986|NCT02236936|Radiation|Radiotherapy|70 Gy / 5 fractions per week, over 7 weeks
16089987|NCT02236910|Other|Lu-DOTA-TATE|
16089988|NCT02236897|Other|PET Scanning|
16089989|NCT02236884|Procedure|no-scar transanal total mesorectal excision(TME)|
16089990|NCT02236871|Behavioral|2 servings|Participants will receive motivational counseling to help the improve milk and milk product intakes to 2 servings per day.
16089991|NCT02236871|Behavioral|4 servings|Participants will receive motivational counseling to help them increase their milk and milk product intake to 4 servings per day.
16089992|NCT02236858|Device|HEPA Air Cleaner|Air cleaners containing HEPA and carbon filters (Austin HealthMate HM400) and capable of removing PM and NO2 will be placed in the bedroom and room where the participant reports spending the most time.
16089993|NCT02236858|Device|Sham HEPA Air Cleaner|Homes in the control group will receive sham air cleaners that have the internal HEPA and carbon filters removed, but which will run normally, including similar noise, airflow and overall appearance compared to active air cleaners, thus blinding participants to filter status.
16089994|NCT02236845|Device|Lacrima Medical Device and sham comparator|
16089995|NCT02236832|Device|transcranial magnetic stimulation|
16089996|NCT02236832|Other|MRI imaging|
16089997|NCT02236832|Other|EEG recording|
16089998|NCT02236832|Behavioral|Neuropsychological examination|
16089999|NCT02236806|Drug|Bisoprolol|5 mg daily
16090000|NCT02236806|Drug|Ramipril|5 mg daily
16090001|NCT02236806|Drug|Placebo|1 capsule daily
16090002|NCT02236793|Drug|BioChaperone PDGF-BB|
16090003|NCT02236793|Other|Standard of Care|
16090004|NCT02236767|Device|Neurostar Transcranial Magnetic Stimulation Therapy System|Treatment will entail daily (5 days/week) sessions of repetitive transcranial magnetic stimulation for 6 weeks employing right-sided, low frequency stimulation (1 Hz, 900 pulses/session for 30 sessions, 27,000 total pulses, intensity at 90% of the passive motor threshold) to the dorsolateral prefrontal cortex (DLPFC).
16090005|NCT02236754|Drug|18F-FP-DTBZ|The drug, no carrier added [18F]-FP-DTBZ, is formulated in 5% (v/v) ethanol in 0.9% sterile saline solution to produce [18F]-FP-DTBZ for injection. Subjects will receive a single i.v. administration of no more than 7.6 mCi of [18F]-FP-DTBZ for injection immediately prior to imaging. The specific activity at time of injection will less than 1.0 mCi/microgram and thus for a 7.6 mCi dose the maximal mass dose will be less than 10 microgram.
16090006|NCT02236754|Radiation|PET Scanning|Individuals will be imaged continuously (i.e. dynamically) for 2 hours.
16090007|NCT02236741|Drug|Mirapexin® (Sifrol®)|
16090008|NCT02236728|Drug|Pramipexole|
16090009|NCT02236715|Drug|Atrovent®|
16090010|NCT02236702|Other|Positron Emission Tomography (PET) imaging|Positron Emission Tomography (PET) imaging
16090011|NCT02236689|Procedure|Non operative|no surgical intervention
16090012|NCT02236689|Procedure|Arthroscopic tennis elbow release|Patients randomized to Arthroscopic tennis elbow release (ATER) will receive arthroscopic release of the origin of the extensor carpi radialis brevis tendon through a standard, two-portal arthroscopic technique (medial and lateral).
16090013|NCT02236676|Behavioral|Nap after rehearsal trials|Behavioral
16090014|NCT02236663|Behavioral|Usual Care Safety Planing App|The control group App will provide women and friends with basic safety planning information and a brief resource list of IPV resources. The resources will be targeted to college students age 18-24 years. The control group App safety plan is not personalized to woman/friend's safety priorities and danger in the relationship.
16090015|NCT02236663|Behavioral|Personalized App-Based Safety Decision Aid|"Setting of priorities for safety: participants will establish priorities by making pairwise comparisons of importance between 5 factors.
~Danger Assessment: asks participants to report on well-established risk factors for repeat violence and lethal IPV. A weighted scoring algorithm provides participants with their validated level of danger and safety planning information and resources based on their level of danger.
~Personalized action plan: Based on a participant's answers to the previous sections, a list of safety strategies with links to resources will be presented tailored to their level of danger and priority settings. The participant is given the option to print results and the personalized plan."
16090016|NCT02236650|Behavioral|Primary Care Stepping Stones Triple P (PC-SS Triple P)|PC-SS Triple P is a parenting and family support strategy that aims to prevent and treat behavioral problems in children by enhancing parental resilience.
16090017|NCT02236650|Other|Treatment as Usual|Treatment as Usual for 4 weeks
16090018|NCT02236624|Behavioral|Aerobic exercise|
16090019|NCT02236611|Drug|Umeclidinium|Umeclidinium 62.5 mcg will be available as dry inhalation powder to be taken using a nDPI
16090020|NCT02236611|Drug|Glycopyrronium|Glycopyrronium bromide will be available as inhalation capsules, 44 mcg per capsule, taken using BREEZHALER inhalers
16090021|NCT02236598|Drug|K+ supplement|
16090023|NCT02236585|Procedure|Patient-controlled epidural analgesia|Patients will receive with patient controlled background infusion of 0.125% bupivacaine plus 2 μg/ml fentanyl that will be set between 4-6 ml/hour (to maintain visual analog scale (VAS) of ≥ 50 mm), intermittent bolus of 10 ml on demand by the women with lockout interval of 20 min with a four-hour maximum dose of 100 mL, irrespective of their age. The epidural infusions will be maintained for the first 24 postoperative hours
16090024|NCT02236585|Procedure|Continuous epidural analgesia|Patients will receive continuous epidural infusion of 0.125% bupivacaine plus 2 μg/ml fentanyl at rate of 6-15 ml/hour (to maintain visual analog scale (VAS) of ≥ 50 mm).
16090025|NCT02236572|Drug|Everolimus|"Aromatase inhibitor plus everolimus by mouth daily for 26 weeks. All patients will begin treatment on Cycle 1 Day 1 with both the standard dose of one of the following 3 aromatase inhibitors ( physician's choice) plus everolimus 10 mg by mouth daily:
~Anastrozole 1 mg
~Letrozole 2.5 mg
~Exemestane 25 mg"
16090026|NCT02236559|Device|Noninvasive positive pressure ventilation (NIPPV)|"Patients will be fit with an oronasal mask using a fitting gauge that will be applied by a respiratory therapist or other clinician skilled in management of NIPPV. Initial pressures will be at low end of suggested range but can be increased as rapidly as necessary to alleviate respiratory distress. Targets should be to lower respiratory rate to the low 20s and achieve tidal volumes of 6-8 ml/kg ideal body weight. If patients find pressures uncomfortably high, they can be lowered as necessary by 1 to 2 cmH2O decrements to enhance tolerance. EPAP (PEEP) can also be adjusted upward as needed to reduce triggering effort (by counterbalancing auto-PEEP) or to improve oxygenation.
~FIO2 will be 1.0 initially to assure adequate oxygenation, but should be adjusted promptly to maintain an FIO2 of no greater than 0.6 with an EPAP (PEEP) of not more than 10 cm H2O to maintain a PaO2 > 88%."
16090027|NCT02236559|Device|Vapotherm|Patients will be fit with a Vapotherm adult nasal cannula that will be applied by a respiratory therapist or other clinician skilled in management of HFT. Initial flow will be set to 35 L/min but can be decreased or increased as rapidly as necessary to alleviate respiratory distress and optimize patient comfort. Targets should be to lower respiratory rate to the low 20s and with a HFT flow rate between 20 to 35 L/min. Starting temperature will be between 35 to 37 C; if patients find the gas temperature to be uncomfortable, it can be lowered as necessary down to 33 C to enhance tolerance. FIO2 will be 1.0 initially to assure adequate oxygenation, but should be adjusted promptly to maintain an FIO2 of no greater than 0.6 to maintain a PaO2 > 88%.
16090028|NCT02236546|Diagnostic Test|[18F]fluorodeoxyglucose|FDG is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.
16090029|NCT02236546|Other|Molecular assays on biopsied tissue|Correlative studies
16090030|NCT02236546|Device|positron emission tomography|Undergo FDG-PET/CT
16090031|NCT02236546|Device|computed tomography|CT that is part of FDG-PET/CT is a low-milliampere, low-resolution scan that is used for anatomic localization and attenuation correction for PET images.
16090032|NCT02236533|Dietary Supplement|whole grain pasta|Volunteers were fed with probiotic fortified pasta or control pasta once a day for 12 weeks.
16090033|NCT02236520|Drug|Spironolactone|
16090034|NCT02236520|Drug|Chlorthalidone|
16090035|NCT02236520|Dietary Supplement|Diet|
16090036|NCT02236520|Drug|Placebo|
16090037|NCT02236507|Device|3D high resolution anorectal manometry|Procedure will take about 15 min. During procedure resting, voluntary squeeze, bear down maneuver, cough reflex, ano-anal reflex and Rectoanal Inhibitory Reflex will be obtained, if possible.
16090038|NCT02236494|Behavioral|Brief Negotiated Interview|As per arm
16090039|NCT02236494|Behavioral|General Health Information|As per arm (this is the active comparator)
16090040|NCT02236481|Drug|Anakinra|
16090041|NCT02236481|Drug|TNF alpha inhibitors|
16090042|NCT02236468|Other|Enhanced-Homestead Food Production Program (old)|Participation in an enhanced-homestead food production program including home gardening and nutrition and health behavior change communication since 2010
16090043|NCT02236468|Behavioral|WASH/malaria behavior change|WASH/malaria behavior change communication
16090044|NCT02236468|Dietary Supplement|LNS distribution|Distribution of Nutributter (Fanga Degue) for children
16090045|NCT02236468|Other|Enhanced-Homestead Food Production Program (new)|Participation in an enhanced-homestead food production program including home gardening, poultry rearing and nutrition and health behavior change communication since 2014
16090046|NCT02236455|Behavioral|Audio Relaxation Technique|Audio relaxation technique created by an Icelandic Registered Nurse.
16090047|NCT02236455|Behavioral|Medical Music Intervention|Audio recordings of non-lyrical relaxing music
16090048|NCT02236455|Behavioral|Nature Therapy without Music|Nature videos of the mountains, desert, Icelandic scenery, and ocean were provided via iPads for surgical patients
16090049|NCT02236455|Behavioral|Nature Therapy with Music|Nature videos of the mountains, forest, Icelandic landscape, and the ocean were provided via iPads for surgical patients
16090050|NCT02236442|Other|Recommendation to use global headache treatment protocol|"The global treatment protocol is :
~Put the patient in a quiet spot, ideally an individual room. Avoid waiting in the corridor
~Lay down the patient on the stretcher. Avoid waiting on a seat or a chair.
~Provide a sound-proof helmet to the patient.
~Provide a light-blocking google to the patient.
~If judged necessary by the physician in charge of the patient, administer oxygen therapy, 15 liter per minute, during 15 minutes.
~If judged necessary by the physician in charge of the patient, administer analgesic treatment adapted to the etiology of the cephalalgia as described :
~Migraine : acetylsalicilyc acid + metoclopramide or nonsteroidal anti inflammatory or paracetamol or triptan.
~Tension headache : nonsteroidal anti inflammatory or paracetamol. Avoid methylmorphine or tramadol if possible.
~Cluster headache : Intravenous or nasal spray sumatriptan and oxygen therapy.
~Other etiology : Treatment left at the discretion of the physician in charge of the patient."
16090051|NCT02236429|Biological|vaginal flora transplant|
16090052|NCT02236416|Behavioral|Intervention group|Supervised, multimodal physical activity including aerobic, resistance and stretching exercises
16090053|NCT02236416|Behavioral|Control group|Usual physical activity, generally consisting in long walks and/or stretching, toning and/or balance exercises, or posture education
16090054|NCT02236403|Drug|Ivermectin 0.1% Metronidazole 1%|
16090055|NCT02236403|Other|None intervention|Volunteers with no signs of blepharitis and with eyelashes with no demodex. Symptoms and signs will be compared with experimental group
16090453|NCT02233244|Drug|CTX-4430|
16090056|NCT02236390|Behavioral|Exposure, Relaxation, and Rescripting Therapy|5 sessions that last approximately one hour addressing nightmares and sleep problems. Participants will log sleep events and associated symptoms
16090057|NCT02236390|Behavioral|Cognitive Processing Therapy - Cognitive|12 sessions cognitive behavioral treatment targeting posttraumatic stress symptoms.
16090058|NCT02236377|Behavioral|Exposure, Relaxation, and Rescripting Therapy|Brief cognitive behavioral treatment targeting trauma-related nightmares and sleep problems
16090059|NCT02236364|Device|Contour, Bayer Healthcare, LLC|Blood glucose measurement
16090060|NCT02236351|Device|Pinch Patch/ flat Patch|
16090061|NCT02236338|Procedure|Ablation of the Incompetent Greater Saphenous Vein|For each patient, the Greater Saphenous Vein (GSV) will be accessed just below the knee. After liberal use of anesthesia, the patient will undergo an ablation of the GSV. Half the patients will have this procedure performed using the Laser Ablation device and half will be treated using the Radiofrequency Ablation device. They will be randomly assigned to treatment.
16090062|NCT02236338|Device|ClosureFAST radiofrequency catheter|
16090063|NCT02236338|Device|EVLT 980nm diode laser system|
16090064|NCT02236325|Behavioral|DBT Brief Suicide Intervention|Participants assigned to the DBT Brief Suicide Intervention are presented with a selection of coping strategies selected from the Dialectical Behavior Therapy (DBT) skills training curriculum. The strategies are 1) mindfulness, 2) mindfulness of current emotions, 3) opposite-to-emotion action, 4) distraction, and 5) changing your body chemistry.
16090065|NCT02236325|Behavioral|Relaxation Training|Participants assigned to the Relaxation Training condition receive instruction in a sensory awareness practice and are guided through the practice by the therapist.
16090066|NCT02236312|Drug|Botulinum Toxin Type A|
16090067|NCT02236312|Drug|Placebo|
16090068|NCT02236299|Procedure|Right Coronary Artery Percutaneous Coronary Intervention|
16090069|NCT02236299|Other|saline placebo infusion|30 minute placebo infusion used as a comparator to the GLP-1 infusion
16090070|NCT02236299|Other|GLP-1 Infusion|30 minute infusion GLP-1
16090071|NCT02236286|Behavioral|Exercise|Agility Boot Camp (ABC) exercise intervention consisting of 18 sessions of group exercise led by an exercise trainer.
16090072|NCT02236273|Behavioral|Conventional text message reminder|Receipt of conventional text message notifying when due for next dose
16090073|NCT02236273|Behavioral|Enhanced text message reminders|Receipt of enhanced text messages notifying when due for next dose coupled with educational information
16090074|NCT02236260|Procedure|Electroacupuncture|Acupuncture will be performed using an electrical stimulator (generating electrical stimulation) for electroacupuncture.
16090075|NCT02236260|Drug|Local Anesthesia (lidocaine hydrochloride)|All patients will receive injectable paracetamol for pain relief, a mix of nitrous oxide 50% and oxygen 50% for analgesia and lidocaine hydrochloride for local anesthesia.
16090076|NCT02236247|Drug|ivabradine|5 mg oral twice daily
16090077|NCT02236247|Drug|Placebo|A placebo pill (identical to ivabradine) will be administered twice daily
16090078|NCT02236234|Biological|HPV vaccine|HPV vaccine
16090079|NCT02236195|Drug|Mocetinostat|
16090080|NCT02236182|Drug|Ipratropium Bromide low dose|
16090081|NCT02236182|Drug|Placebo|
16090082|NCT02236182|Drug|Ipratropium Bromide high dose|
16090083|NCT02236169|Drug|Ipratropium bromide HFA-134a inhalation aerosol|
16090084|NCT02236169|Drug|Atrovent CFC inhalation aerosol|
16090085|NCT02236156|Drug|Metronidazole oral tablets 500mg|One tablet taken orally twice daily for seven consecutive days
16090086|NCT02236156|Drug|1% SPL7013 Gel|5g inserted in to the vaginal on alternate days (i.e. every other day) for 16 consecutive weeks.
16090087|NCT02236156|Drug|Placebo gel|5g inserted in to the vagina on alternate days (i.e. every other day) for 16 consecutive weeks
16090088|NCT02236130|Procedure|Regional block|Single shot peripheral nerve block
16090089|NCT02236130|Procedure|General Anesthesia|General Anesthesia with O2/N2O/Sevoflurane
16090090|NCT02236130|Drug|Local Anesthetic Ropivacaine|0.5% Ropivacaine
16090091|NCT02236130|Drug|Opioids Morphine|Morphine
16090092|NCT02236130|Drug|Oral pain medication Acetaminophen with Hydrocodone|Acetaminophen with Hydrocodone
16090093|NCT02236117|Other|Aerobic Training|Will be included 160 children, 80 in an experimental group and 80 in a control group of both genders. The experimental group will realize aerobic training during 10 weeks (3×40min week-1; intensity, >80% maximal aerobic velocity - MAV), while the control group will have involved with the physical education classes two times a week for 50 minutes each class. The aerobic protocol will be composed by 2 sessions of intermittent running and 1 session by continuous.
16090094|NCT02236104|Device|Plethysmography opto electronic|
16090095|NCT02236104|Procedure|respiratory parameters|
16090096|NCT02236078|Drug|High dose isoniazid|See arm description
16090097|NCT02236065|Procedure|Umbilical cord blood therapy|
16090098|NCT02236065|Biological|Filgrastim|
16090099|NCT02236052|Biological|Non-adjuvanted low dose of quadrivalent VLP vaccine|A single non-adjuvanted low dose of quadrivalent VLP vaccine
16090100|NCT02236052|Biological|Non-adjuvanted medium dose of quadrivalent VLP vaccine|A single non-adjuvanted medium dose of quadrivalent VLP vaccine
16090101|NCT02236052|Biological|Non-adjuvanted high dose of quadrivalent VLP vaccine|A single non-adjuvanted high dose of quadrivalent VLP vaccine
16090102|NCT02236052|Biological|Adjuvanted low dose of quadrivalent VLP vaccine|A single low dose of quadrivalent VLP vaccine mixed with Alhydrogel®
16090103|NCT02236052|Biological|Adjuvanted high dose of quadrivalent VLP vaccine|A single high dose of quadrivalent VLP vaccine mixed with Alhydrogel®
16090104|NCT02236052|Biological|Placebo|A single dose of placebo
16090105|NCT02236039|Procedure|Bronchoscopy|Bronchoscopy with biopsy sampling, brushings and bronchoalveolar lavage (BAL) 24 hours post exposure.
16090106|NCT02236026|Drug|Supratherapuetic dose of Nestorone|
16090107|NCT02236026|Drug|Placebo|
16090108|NCT02236026|Drug|Moxifloxacin|
16090109|NCT02236013|Drug|Gilteritinib|Oral
16090110|NCT02236013|Drug|Idarubicin|lyophilized powder administered intravenously
16090111|NCT02236013|Drug|Cytarabine|solution administered intravenously
16090112|NCT02236013|Drug|Daunorubicin|solution administered intravenously
16090113|NCT02236000|Drug|Neratinib|"Dose-Escalation Phase (Part 1) - Neratinib Dose-escalation will proceed on the basis of DLT during Cycle 1 starting at 120 mg/day.
~Dose level 1: 120 mg/day; Dose level 2: 160 mg/day; Dose level 3: 200 mg/day; Dose level 4: 240 mg/day
~Dose-evaluation Phase (Part 2) - Patients will receive the highest dose of neratinib with T-DM1 found in Phase I as study therapy"
16090114|NCT02236000|Drug|T-DM1|"Dose-Escalation Phase (Part 1) - Trastuzumab emtansine (T-DM1) will be given at 3.6 mg/kg IV Day 1 every 21 days.
~Dose-evaluation Phase (Part 2) - Trastuzumab emtansine (T-DM1) will be given at 3.6 mg/kg IV Day 1 every 21 days."
16090115|NCT02235987|Drug|octreotide|Eligible patients are to receive 300 µg octreotide as active comparator, followed by four ascending doses of 100 µg, 300 µg, 900 µg and 1800 µg DG3173. All treatments will be administered consecutively to all patients as single subcutaneous bolus injections.
16090116|NCT02235987|Drug|DG3173|Eligible patients are to receive 300 µg octreotide as active comparator, followed by four ascending doses of 100 µg, 300 µg, 900 µg and 1800 µg DG3173. All treatments will be administered consecutively to all patients as single subcutaneous bolus injections.
16090117|NCT02235974|Behavioral|Early Intensive upper extremity motor training|Using a shaping therapy protocol, participants will receive a dose of 20 hours of intensive upper extremity therapy (in addition to their current therapy) beginning within 30 days of stroke onset.
16090118|NCT02235974|Behavioral|Sub-acute intensive upper extremity motor training|Using a shaping therapy protocol, participants will receive a dose of 20 hours of intensive upper extremity therapy (in addition to their current therapy) beginning within 2 to 3 months post stroke.
16090119|NCT02235974|Behavioral|Chronic intensive upper extremity motor training|Using a shaping therapy protocol, participants will receive a dose of 20 hours of intensive upper extremity therapy (in addition to their current therapy) beginning within 6 to 9 months post stroke.
16090120|NCT02235974|Behavioral|Control|Usual and Customary Care only. No additional therapy will be given during the 1-year study.
16090121|NCT02235961|Drug|NNC9204-0530|Administered as single subcutaneous (s.c., under the skin) injections.
16090122|NCT02235961|Drug|liraglutide|Administered as subcutaneous (s.c., under the skin) injections of 1.8 or 3.0 mg.
16090123|NCT02235961|Drug|placebo|Administered as single subcutaneous (s.c., under the skin) injections.
16090124|NCT02235948|Drug|folic acid supplementation|0.8mg folic acid/day
16090125|NCT02235922|Other|Dual task training|The dual task training consisted of individuals subjected to a multicomponent exercise program associated to cognitive tasks.
16090126|NCT02235922|Other|Conventional training|The conventional training consisted of individuals subjected to a multicomponent exercise program.
16090127|NCT02235909|Drug|Azilsartan Medoxomil|
16090128|NCT02235909|Drug|Losartan|
16090129|NCT02235909|Drug|Placebo for Azilsartan Medoxomil|
16090130|NCT02235909|Drug|Placebo for Losartan|
16090131|NCT02235909|Drug|antihypertension medication|"If add-on therapy is needed, the type of medication (eg a calcium channel blocker, such as amlodipine, a diuretic, such as hydrochlorothiazide, or a beta-blocker such as metoprolol) added will be determined per the investigator's clinical judgment.. These are not predefined."
16090132|NCT02235896|Behavioral|Education/Behavior Modification|Education, lifestyle counseling, experiential cooking, exercise classes.
16090133|NCT02235870|Device|Obalon Intragastric Balloons|Intragastric Balloon System to aid in portion control.
16090134|NCT02235870|Device|Sham Device|Sham Intragastric Balloon
16090135|NCT02235870|Behavioral|Nutrition and Lifestyle Program|Nutrition and lifestyle program reviewed with subjects every 3 weeks for 6 months.
16090136|NCT02235857|Device|LIPOSORBER® LA-15 System|LIPOSORBER® LA-15 System is an extracorporeal blood purification system. Approximately 3 to 4 L of plasma is treated in a single treatment session and it takes 2 to 3 hours. Recommended frequency of the treatment is twice weekly for 3 weeks followed by once weekly for 6 weeks, thus it takes 9 weeks for a total of 12 treatment sessions.
16090137|NCT02235844|Biological|Umbilical Cord Mesenchymal Stem Cells|
16090138|NCT02235831|Device|Nelfilcon A MF contact lenses (DACP MF)|Multifocal contact lenses in Low, Medium, High Add
16090139|NCT02235831|Device|Nelfilcon A single vision contact lenses (DACP)|
16090140|NCT02235818|Device|Kinesiotape|Pre-cut kinesiotape for tennis elbow, spidertech.com, applied on wrist extensors starting above elbow and ending at distal one third of forearm
16090141|NCT02235818|Device|Counterforce elbow brace|Applied over the wrist extensor muscle mass, had velcro for adjustment, comfortable grip as reported by patient was used to adjust the brace
16090142|NCT02235805|Dietary Supplement|Magnesium Citrate|One capsule thrice daily that contains magnesium citrate (total daily dose: 350 mg elemental magnesium) at breakfast, lunch and dinner for 24 weeks
16090143|NCT02235805|Dietary Supplement|Placebo|One capsule thrice daily that contains placebo at breakfast, lunch and dinner for 24 weeks
16090144|NCT02235792|Device|Activa PC+S|The model 37604 Activa PC+S system is a multiprogrammable device that both delivers electrical stimulation and records bioelectric data through one or two leads implanted in the brain.
16090145|NCT02235779|Other|Transbronchial lung cryobiopsy|
16090146|NCT02235766|Other|Echocardiographic assessment|
16090147|NCT02235753|Behavioral|High-intensity aerobic interval training, short interval|The intensity of HIT-S sessions (cycle ergometer) will be increased during 3 to 6 months from 60% of VO2peak to 100% which will be the target intensity from 6 to 12 months. The protocol includes four 6 min sets consisting of 15 sec exercise followed by 15 sec passive recovery separated with 3 min passive recovery between sets. Exercise session will last ca. 40 min, with 12 min of HIT, warm-up and recovery. The intensity of the 15 seconds exercise bouts will be based on VO2peak at baseline and after 6 months. Meanwhile, the estimated VO2peak from the submaximal test will be used to adjust the training intensity in HIT sessions. Training will be conducted in a group of 1-3 HIT-S patients with ECG monitoring and supervised by physician.
16090194|NCT02235389|Drug|Alteplase (Actilyse)|
16090195|NCT02235389|Drug|Standard therapy|
16090196|NCT02235376|Other|weaning trial of mechanical ventilation|
16090261|NCT02234843|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Age and body weight-adjusted dosing equivalent to 20 mg rivaroxaban in adults, once daily or twice daily, as tablets
16090262|NCT02234843|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Age and body weight-adjusted dosing equivalent to 20 mg rivaroxaban in adults, once daily, twice daily or three times daily, as oral suspension
16090148|NCT02235753|Behavioral|High-intensity aerobic interval training, long interval|The intensity of HIT-L sessions (cycle ergometer) will be increased during 3 to 6 months from 60% of VO2peak to 90% which will be the target intensity from 6 to 12 months. The protocol includes four 3 min exercise bouts with a 4 min recovery (pedaling at 0 W) between bouts. Exercise session will last ca. 40 min, with 12 min of HIT, warm-up and recovery. The intensity of the 3 min exercise bouts will be based on VO2peak at baseline and after 6 months. Meanwhile, the estimated VO2peak from the submaximal test will be used to adjust the training intensity in HIT sessions. Training will be conducted in a group of 1-3 HIT-L patients with ECG monitoring and supervised by physician.
16090149|NCT02235740|Drug|Afuresertib|Afuresertib will be dosed orally in morning, and will be sourced as opaque, white, size 4, 25 mg capsule and size 1, 100 mg capsules.
16090150|NCT02235740|Drug|Carfilzomib|Intravenous (IV) Carfilzomib will be sourced in the US from commercial stock. It will be a single-use 60 mg vial as a sterile, white to off-white lyophilized cake or powder
16090151|NCT02235727|Drug|GBR 900|
16090152|NCT02235727|Drug|Placebo|
16090153|NCT02235701|Drug|aldoxorubicin|administered at 170 mg/m2 plus 1 gm/m2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days
16090154|NCT02235701|Drug|aldoxorubicin|administered at 250 mg/m2 plus 1 gm/m2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days
16090155|NCT02235701|Drug|aldoxorubicin|administered 350 mg/m2 plus 1 gm/m2/day ifosfamide by continuous intravenous infusion for up to 14 days on Day 1 every 28 days
16090156|NCT02235701|Drug|ifosfamide|
16090157|NCT02235688|Drug|aldoxorubicin|administered at 170 mg/m2 by intravenous infusion (IVI) on Day 1 every 21 days plus 900 mg/m2 gemcitabine on Days 1 and 8 every 21 days.
16090158|NCT02235688|Drug|aldoxorubicin|administered at 250 mg/m2 by intravenous infusion (IVI) on Day 1 every 21 days plus 900 mg/m2 gemcitabine on Days 1 and 8 every 21 days.
16090159|NCT02235688|Drug|aldoxorubicin|administered at 350 mg/m2 by intravenous infusion (IVI) on Day 1 every 21 days plus 900 mg/m2 gemcitabine on Days 1 and 8 every 21 days.
16090160|NCT02235688|Drug|gemcitabine|
16090161|NCT02235675|Device|Tack-It Endovascular System|Repair of post-PTA dissections using the Intact Vascular Tack-It implant.
16090162|NCT02235662|Drug|TFV IVR|
16090163|NCT02235662|Drug|TFV/LNG IVR|
16090164|NCT02235662|Other|Placebo IVR|
16090165|NCT02235649|Behavioral|Social Cognition therapy ( Psychological Therapy)|
16090166|NCT02235623|Procedure|Single-stage Fowler-Stephens orchidopexy (FSO)|
16090167|NCT02235623|Procedure|Two-stage Fowler-Stephens orchidopexy (FSO)|
16090168|NCT02235610|Procedure|EVLP Group|"EVLP technique (Lund Protocol): open left atrium, Steen solution mixed with red blood cells and perfusion 100% of the donor predicted cardiac output.
~Lungs with good and stable function during EVLP will be transplanted into recipients as per current clinical practice."
16090169|NCT02235584|Drug|Dexamethasone|Dexamethasone are given dexamethasone tablets of 2mg twice daily.
16090170|NCT02235571|Behavioral|iChoose Kidney Decision Aid|Providers will use a shared decision making tool with patients via iPhone, iPad, or web which explains predicted individualized risk of mortality on dialysis vs. transplant during the evaluation appointment for kidney transplant.
16090171|NCT02235558|Drug|Verapamil|Super-selective intra-arterial administration of 10mg verapamil in 20cc of normal saline will be administered over 20 minutes (1cc/minute) through the microcatheter and into the vessel previously obstructed by clot, immediately following successful intra-arterial thrombolysis. Half-life is 2.8-7.4 hrs.
16090172|NCT02235545|Device|St. Jude Medical Optisure Lead|Patients implanted with St. Jude Medical Optisure Lead
16090173|NCT02235532|Other|Foramen Herbal Aloe toothpaste|use of aloe-vera toothpaste for 30 days in the test group.
16090174|NCT02235532|Other|fluoride toothpaste|use of signal toothpaste once a day for 30 days in the control group.
16090175|NCT02235519|Drug|Azilsartan 40 mg.|Patients will take 40 mg of azilsartan during 12 weeks
16090176|NCT02235519|Drug|Azilsartan 80 mg|Patients will take 80 mg of azilsartan during 12 weeks
16090177|NCT02235506|Procedure|epidural infusion|Lumbar epidural catheter is placed at the L3-4 level using loss-ofresistance procedure. Fentayl 2mcg/ml and 0.2% ropivacaine are infused at a rate of 5ml/hr.
16090178|NCT02235506|Procedure|femoral sciatic|After femoral and sciatic nerve are identified using ultrasound, 0.2% ropivacaine 20 mL is injected. A catheter is inserted to femoral nerve and 0.2% ropivacaine is infused through the femoral catheter at a rate of 5ml/hr from the end of surgery.
16090179|NCT02235506|Device|epidural infusion|Lumbar epidural catheter is placed at the L3-4 level using loss-ofresistance procedure. Fentayl 2mcg/ml and 0.2% ropivacaine are infused at a rate of 5ml/hr.
16090180|NCT02235506|Device|femoral sciatic|After femoral and sciatic nerve are identified using ultrasound, 0.2% ropivacaine 20 mL is injected. A catheter is inserted to femoral nerve and 0.2% ropivacaine is infused through the femoral catheter at a rate of 5ml/hr from the end of surgery.
16090181|NCT02235493|Biological|Retrospective Case Only|
16090182|NCT02235480|Drug|Experimental Tazarotene Gel|
16090183|NCT02235480|Drug|Placebo|
16090184|NCT02235467|Behavioral|ABA parent training|A parent training based on Applied Behavior Analysis that is going to be delivered by video modeling in 21 weeks
16090185|NCT02235454|Device|SDOCT-GMPE software|Noninvasive imaging of the optic nerve in patients with existing glaucoma
16090186|NCT02235441|Other|Cardiopulmonary Exercise Test (CPET)|All subjects will undergo a maximal cardiopulmonary exercise test and resting metabolic rate study. Prior to the exercise treadmill test, each subject will have a resting ECG and blood pressure to determine whether there are any abnormalities that would contraindicate exercise testing.This exercise test involves exercising on a treadmill to maximal exertion, during which the subject's breathing and oxygen consumption are measured. The subject will wear nose clips to prevent exhaling air through their nose and a mouth piece that will allow all exhaled air to be analyzed through the metabolic cart. The subject's electrocardiogram (ECG), blood pressure, and perceived exertion are monitored throughout the test by trained personnel.
16090187|NCT02235428|Drug|Ipratropium bromide|
16090188|NCT02235428|Drug|Placebo|
16090189|NCT02235428|Drug|Salbutamol|
16090190|NCT02235415|Drug|Motens® (lacidipine)|
16090191|NCT02235402|Drug|Lacidipine|
16090192|NCT02235402|Drug|Bendrofluazide|
16090197|NCT02235363|Procedure|thread lift|In facial rejuvenating surgery, the current trend calls for fewer and less noticeable scars with desired results. Especially to improve the jowls and nasolabial folds, the thread lift is a simple and inexpensive technique for patients who do not wish to undergo the typical facelift surgery, but the weak points of it are less effective and shorter duration than the conventional facelift.The investigators propose the new method of the thread lifting the subdermal and subcutaneous layer by use of the retaining ligaments with two fixation points on both temporal fascia and retaining ligaments.
16090198|NCT02235350|Other|Action Observation Treatment (AOT)|Participants will be asked to carefully observe at a computer screen videos depicting different daily actions. Each action will consist of 3 to 4 constituent motor acts. Each motor act will be presented for 3 minutes. As a whole, therefore, each video will be 12 minutes long. At the end of each motor act presentation, participants will be required to execute with the affected hand the observed motor sequence for 2 minutes. Each single rehabilitation session based on AOT will last 20 minutes. We will record ten daily actions for a total of ten video-clips. Participants will be presented with each video clips, twice a day, in order of complexity as judged by the experimenter. Participants will undergo 10 sessions a week, each lasting 20 minutes for 2 weeks.
16090199|NCT02235350|Other|Observation of videos with no motor content (MNO)|Participants will be asked to observe video clips with no specific motor content. Videos will concern scientific, geographical and historical issues. As for cases, video clips will be divided into three to four parts. At the end of each part, controls will execute the same actions as cases, in the same order. In this way cases and controls will undergo the same amount of motor practice and receive the same amount of visual stimulation, the only difference being the content of visual stimuli.
16090200|NCT02235337|Drug|Riboflavin 400mg daily|
16090201|NCT02235324|Biological|ziv-aflibercept|Given IV
16090202|NCT02235324|Drug|leucovorin calcium|Given IV
16090203|NCT02235324|Drug|fluorouracil|Given IV
16090204|NCT02235324|Other|laboratory biomarker analysis|Correlative studies
16090205|NCT02235311|Drug|Pantoprazole|Pantoprazole 40mg orally daily x 8 weeks after acute management of UGIB
16090206|NCT02235298|Drug|Dapagliflozin|5 mg taken orally once daily. After 2 weeks, if there are no safety issues as per treating physician discretion, the dose can be titrated up to 10 mg orally taken once daily.
16090207|NCT02235298|Drug|Metformin|500 mg taken orally twice daily to a maximum of 1000 mg twice daily to achieve a fasting glucose between 80-140 md/dL
16090208|NCT02235298|Drug|Placebo|Placebo pill taken once daily to mimic Dapagliflozin
16090209|NCT02235285|Procedure|primary breast augmentation|With the patient under sedative anesthesia, wide preparation and draping by using povidone-iodine are performed with using talc-free gloves and povidone-iodine gauze nipple shields. Tumescent solution is infiltrated in the precise plane. Pockets are developed precisely with blunt dissection with fingers and instruments under both direct and indirect visions simultaneously, if needed, with using endoscopy, while careful hemostasis done. After dissection, two pockets are irrigated with 300ml of single antibiotic solution without active evacuation of the irrigation. When re-draping and re-preparation by using povidone-iodine are performed before implant insertion, a new pair of talc-free gloves is used and cleansed with the single antibiotic solution.
16090210|NCT02235272|Drug|XG-102|Comparison of XG-102 versus placebo sub-conjunctival injection efficacy
16090211|NCT02235272|Drug|Placebo|comparison of XG-102 versus placebo sub-conjunctival injection efficacy
16090212|NCT02235259|Drug|XG-104|Comparison of XG-104 (3 concentrations) versus placebo eye drops efficacy
16090213|NCT02235259|Drug|Placebo|
16090214|NCT02235246|Drug|Magnesium Sulfate|magnesium sulfate 50 mg/kg will be administrated during 10 min before anesthetic induction in patients undergoing endoscopic submucosal dissection.
16090215|NCT02235246|Drug|Normal saline|Normal saline will be administrated during 10 min before anesethetic induction in patients undergoing endoscopic submucosal dissection.
16090216|NCT02235233|Drug|Technetium Tc 99M Mebrofenin|Each subject will be injected with ~2.5 mCi of Technetium Tc 99M Mebrofenin
16090217|NCT02235220|Other|Composite resin restoration|"Masticatory muscular activity is measured before and after treatment with additive composite resin fillings (Tetric EvoCeram, Ivoclar Vivadent, Schaan, Liechtenstein). A Grindcare (Medotech A/S, Herlev, Denmark) device is used for determination of muscular activity.
~A first measurement is conducted, followed by 4 weeks without any intervention. A second measurement is then carried out before restoration of the canine cusps with composite fillings. A third measurement is conducted, again followed by 4 weeks without any intervention. At last a final measurement is conducted."
16090218|NCT02235207|Behavioral|Neuromuscular exercise|"Fustra20 Neck & Back is individually guided, graded neuromuscular exercise program which is conducted twice a week for 20 times. Each session lasts one hour. After 20 sessions participants are encouraged to continue exercising at home with a help of an individual home exercise plan including diary of compliance.
~The main targets are to
~improve movement control in different posture and movements of the neck and back
~improve flexibility with active functional movements
~improve pelvic, spine and shoulder-neck stability using co-contraction of several muscle groups, and thus enhancing gross movement of the whole kinetic chain
~improve muscular endurance of shoulder neck area, trunk, pelvis and lower extremities"
16090219|NCT02235194|Dietary Supplement|Amino Acid and chromium-picolinate containing drink|Amino Acid and chromium - picolinate containg water ist taken with a test meal to study efects on glucose and insulin response.
16090220|NCT02235194|Dietary Supplement|Placebo Drink|Placebo drink ist taken with a test meal to study efects on glucose and insulin response.
16090221|NCT02235181|Device|Arabin Cervical Pessary|The Arabin pessary is CE-certified for preventing Spontaneous Preterm Birth (SPB) (CE 0482 / EN ISO 13485: 2003 annex III of the council directive 93/42 EEC) and is being used in this study as per the CE certification and manufacturer's guidance.
16090222|NCT02235168|Procedure|six minute walking test|
16090223|NCT02235142|Other|Blood sample|
16090224|NCT02235129|Other|breath-holding|
16090225|NCT02235116|Other|Survey|
16090226|NCT02235103|Other|Sperm Chromatin Dispersion Test|
16090227|NCT02235090|Other|Direct current stimulation of cervical spinal cord|10 minutes direct current stimulation of 0, 100 microamperes, 1 milliampere strengths applied through dermal electrodes to cervical spinal cord
16090263|NCT02234843|Drug|Standard of Care|"LMWH (low molecular weight heparin) or fondaparinux or vitamin K antagonist (VKA) therapy.
~dose : as per standard of care"
16090228|NCT02235077|Drug|Spironolactone|"Patients receiving no MRA at home will receive spironolactone 100 mg (4x25 mg capsules) once daily for 96 hours.
~Patients already receiving low-dose MRA at home will be randomized to receive spironolactone 25 mg (1x25 mg capsules) or 100 mg (4x25 mg capsules) in hospital for 96 hours. The patients who are randomized to 25 mg spironolactone will also receive 75 mg placebo (3x25 mg capsules) in order to maintain blinding."
16090229|NCT02235077|Drug|Placebo|"Patients receiving no MRA at home will receive 100 mg placebo (4x25 mg capsules) once daily for 96 hours.
~Patients who are randomized to 25 mg spironolactone will also receive 75 mg placebo (3x25 mg capsules) in order to maintain blinding."
16090230|NCT02235064|Drug|Sertraline|Capsule containing crushed sertraline 50 mg tablets mixed with identically colored cellulose, with 4 day 25 mg taper
16090231|NCT02235064|Drug|Placebo|Capsule containing cellulose powder of same color as experimental arm
16090232|NCT02235051|Behavioral|exercise intervention|Undergo Curves exercise program
16090233|NCT02235051|Other|laboratory biomarker analysis|Correlative studies
16090234|NCT02235051|Other|questionnaire administration|Ancillary studies
16090235|NCT02235051|Other|quality-of-life assessment|Ancillary studies
16090236|NCT02235038|Behavioral|Low carbohydrate diet|Composition (by proportion of calories) : 15% carbohydrate, 65% fat, 20% protein
16090237|NCT02235038|Behavioral|Moderate carbohydrate diet|Feeding study. Composition (by proportion of calories): 40% carbohydrate, 40% fat, 20% protein
16090238|NCT02235038|Behavioral|High carbohydrate diet|Feeding study. Composition (by proportion of calories): 60% carbohydrate, 20% fat, 20% protein
16090239|NCT02235025|Other|Cardio-pulmonary exercise testing|
16090240|NCT02235012|Drug|Ketamine|"KETAMINE PANPHARMA 250 mg/5mL, solution for infusion :
~Initial rapid infusion of 0,23 mg/kg
~Infusion from minute 2 to minute 30 : 0,00967 mg/kg/min
~Infusion from minute 31 to minute 120 : 0,00483 mg/kg/min"
16090241|NCT02235012|Drug|Placebo|"CHLORURE DE SODIUM 0,9 % MACOPHARMA :
~Initial rapid infusion of 0,23 mg/kg
~Infusion from minute 2 to minute 30 : 0,00967 mg/kg/min
~Infusion from minute 31 to minute 120 : 0,00483 mg/kg/min"
16090242|NCT02234999|Drug|CC-122|3mg [14C]-CC-122 will be administered as a single dose
16090243|NCT02234986|Drug|ENMD-2076|250 mg oral dose, QD for 28 day cycles
16090244|NCT02234973|Behavioral|Quality Improvement|Community and Clinical Teams engaged in implementing Quality Improvement initiatives to improve diabetes prevention and management within their First Nations community and clinic.
16090245|NCT02234960|Drug|Tocilizumab|Tocilizumab will be given according to summary of product characteristics as per clinical practice.
16090246|NCT02234947|Procedure|MRI, US, and blood samples|All groups will have pancreatic volume assessment by ultrasonography (US), Magnetic Resonance Imaging (MRI) and blood samples. These test will be compared to the testing from the other groups.
16090247|NCT02234934|Biological|Lentiviral G1XCGD Gene Therapy|"The investigational product is patient-specific and corresponds to autologous CD34+ cells transduced ex vivo with the G1XCGD vector in their final suspension. The starting materials used for the production of the investigational product consist of the viral vector and the patient's CD34+ cells.
~The G1XCGD vector is used to transduce autologous CD34+ cells ex vivo. These transduced cells are then frozen, and an aliquot tested and characterized for quality. If the cell product passes release criteria, it is thawed at bedside and infused into the patient after the patient has received myelo-ablative conditioning. The cell/product dose will consist of at least 3 x 10^6 cells per kg of body weight transduced ex vivo with 1 x 10^8 IG/mL of lentiviral vector to achieve > 0.3 integrated copies per cell."
16090248|NCT02234921|Drug|Cyclophosphamide|A single dose of cyclophosphamide, 300 mg/m2, will be administered intravenously 3 Days prior to the first vaccine.
16090249|NCT02234921|Biological|DRibble Vaccine|DRibble vaccine will be administered at Weeks 1, 4, 7, 10, 13, 16, 19 and 22. Eight vaccinations will be administered. Week 1 and 4 vaccines will be administered by intranodal injections performed using ultrasound guidance.
16090250|NCT02234921|Biological|HPV Vaccinations|Patients will receive a dose of 0.5-mL CERVARIX at week 1 (Day 4) and week 7 by intramuscular injection at a site distant from the DRibble vaccine.
16090251|NCT02234921|Drug|Imiquimod|Imiquimod cream (5%, 250 mg) will be self-applied topically for 5 consecutive days by patients to a 4 x 5-cm outlined area of healthy extremity skin starting on the day of the second vaccine and again during each additional vaccine cycle.
16090252|NCT02234908|Behavioral|Contacts|Household contacts who come to the study clinic, present a referral card, and complete TB symptom screening will receive a shopping voucher of $5-10 value.
16090253|NCT02234908|Behavioral|Index|Index subjects will be entered in a prize lottery if any of their contacts complete TB symptom screening at the study clinic.
16090254|NCT02234895|Device|Lateral wedge|This will be a randomized cross-over study where all participants will receive both orthoses over a six month period. Each intervention will last two months, separated by a two month washout period of no orthotics wear, and will be preceded and followed by a laboratory-based gait and pain assessment. Two months has been chosen as the ideal time frame to ensure maximum participant adherence, to observe clinically meaningful changes in symptoms, and to minimize degradation of the insoles.
16090255|NCT02234895|Device|Lateral wedge plus medial arch support|This will be a randomized cross-over study where all participants will receive both orthoses over a six month period. Each intervention will last two months, separated by a two month washout period of no orthotics wear, and will be preceded and followed by a laboratory-based gait and pain assessment. Two months has been chosen as the ideal time frame to ensure maximum participant adherence, to observe clinically meaningful changes in symptoms, and to minimize degradation of the insoles.
16090256|NCT02234882|Drug|Rosuvastatin|
16090257|NCT02234882|Drug|BMS-663068|
16090258|NCT02234869|Drug|Interferon Beta|Subcutaneous injection
16090259|NCT02234869|Drug|BIIB017 (Peginterferon beta-1a)|Single-use, disposable, prefilled pen for subcutaneous injection
16090260|NCT02234856|Procedure|Laparoscopic Hysterectomy trainer|In order to increase comfort level amongst Gynecologists, we aim to identify verbal and non-verbal components of teaching TLH through interview and video recordings. Utilizing qualitative analysis of common themes, we will develop an educational video and web-based e-module to be used by Gynecology residents and surgeons. We will also use a combination of quantitative pre- and post-tests and qualitative surveys to assess the effectiveness of such a training tool. Ultimately, the project aims to create a robust tool that can be implemented in Gynecology residencies.
16090264|NCT02234830|Device|Exoseal closure device|Closure device for femoral artery access closure
16090265|NCT02234830|Device|Angioseal closure device|Closure device for femoral artery access closure
16090266|NCT02234804|Device|Xience Prime Stent|
16090267|NCT02234804|Device|Medtronic Resolute Integrity stent|
16090268|NCT02234804|Procedure|Angiography|
16090269|NCT02234804|Procedure|OCT|
16090270|NCT02234778|Device|TGI SVF material via intramuscular injection|Each SVF-treated subject will receive up to 30 cc of the TGI SVF material via intramuscular injection (injections at multiple locations on the lower leg - up to 20 total injections) through a 23 gauge needle over a 2- to 4- minute period.
16090271|NCT02234765|Other|Primary Care-based management|Patients will be diagnosed and follow-up in Primary Care.
16090272|NCT02234765|Other|Standard management|Standard management according to Spanish Respiratory Society guidelines in Sleep Unit.
16090273|NCT02234752|Drug|Galantamine ER|
16090274|NCT02234752|Drug|Memantine XR|
16090275|NCT02234739|Drug|Voriconazole|2-week long intravenous instillation of voriconazole
16090276|NCT02234726|Behavioral|Early Childhood Development Program|"A cadre of community-based health workers, Child Development Agents (CDAs), have four main tasks and responsibilities: 1) biweekly screening and management (including referral) of acute malnutrition in children; 2) encouragement of caregivers to utilize routine care services for children; 3) screening for symptoms of acute diseases and referral for diagnosis and treatment; and 4) organization and mentoring of weekly meetings for caregivers to discuss parenting issues and promote early childhood cognitive stimulation.
~Amendment: during second year extension, CDAs are responsible for organizing and mentoring biweekly (i.e., fortnightly) caregiver meetings. They no longer conduct household visits."
16090277|NCT02234713|Behavioral|Motivational Interview|
16090278|NCT02234713|Other|Video Attention Control|
16090279|NCT02234687|Drug|Pomaglumetad Methionil 160mg|Pomaglumetad Methionil 160mg, one dose, one time
16090280|NCT02234687|Drug|Pomaglumetad Methionil 40mg|Pomaglumetad Methionil 40mg, one dose, one time
16090281|NCT02234687|Drug|Placebo|Placebo, one dose, one time
16090282|NCT02234674|Other|Current intensive CDP|"Standard Intensive CDP including
~manual lymph drainage,
~pressotherapy and
~bandaging"
16090283|NCT02234674|Other|intensive CDP where Stendo pulsating suit replaces pressotherapy|The intervention consist to perform daily during 5 days an intensive CDP where pressotheray is replaced by Stndo pulsating suit sessions.
16090284|NCT02234661|Behavioral|CareerAdvance®|CareerAdvance® is a dual-generation program providing education, career coaching, and soft-skills training for parents while their children attend CAP Tulsa's Head Start programs.
16090285|NCT02234648|Dietary Supplement|60mL tart Montmorency cherry juice|One bolus of 60mL of tart Montmorency concentrate mixed with 100mL of water.
16090286|NCT02234648|Other|Placebo|One bolus of less than 5% fruit cordial mixed with water, maltodextrin and whey protein isolate to match for carbohydrate and calorie content of the juice.
16090287|NCT02234635|Other|Diffractive multifocal IOLs group|Diffractive IOLs are a type of multifocal (bifocal) IOL that are based on the Huygens-Fresnel principle. Specifically, a diffractive IOL has concentric rings in its posterior surface that form 2 primary focal points independent of pupil size. This optical behavior of the IOL can effectively restore far and near vision. However, it can also cause side effects, such as halos and glare and loss of contrast sensitivity.
16090288|NCT02234622|Behavioral|Holistic Yoga Program|The Holistic Yoga Program (HYP) (postures, breathing practices, deep muscle contraction practices, relaxation) is a 16 week, 90 minute weekly group intervention.
16090289|NCT02234622|Behavioral|Wellness Lifestyle Program|The Wellness Lifestyle Program (WLP) is a 16 week, 90 minute weekly group intervention consisting of low intensity walking with didactics about wellness topics.
16090290|NCT02234609|Device|modified ART class IV|Carious tissue was removed with an excavator until a sound probing was obtained. Restorations were performed using a mechanically improved glass-ionomer cement for ART. The modified class IV ART restoration was inserted into the cavity using a spatula. By these restoration technique, the cavity was (i) sealed to stop further caries progression. The cavity was (ii) capped to protect the vital dentin-pulp-complex from external stimuli. The modified class IV ART was aimed at conserving the carious incisor for prospective functional use and for prolonging tooth preservation rather than at anatomical reconstruction of the tooth form for cosmetic reasons.
16090291|NCT02234596|Drug|Nintedanib|Nintedanib 200mg twice daily administered continuously. Patients will continue on treatment until progression of disease. Each cycle consists of 28 days continuously, unless interrupted for intolerable toxicity.
16090292|NCT02234583|Drug|DS-5565|DS-5565 15 mg tablet for oral administration
16090293|NCT02234570|Drug|Oxfendazole|A benzimidazole carbamate antiparasitic drug. Oral Dose levels of 0.5,1, 3, 7.5, 15, 30, and 60 mg/kg will be evaluated sequentially, the dose increasing with each new cohort Group 1 to Group 7.
16090294|NCT02234570|Other|Placebo|Normal Saline administered with an oral dosing syringe. Group 1- Group 6
16090295|NCT02234557|Behavioral|Tai Chi|"6-8 students will be enrolled in 8 weeks of Tai Chi instruction, with two 1-hour sessions per week. Students will be requested to practice from recorded materials at home three times a week for 15-30 minutes each session, and parents will be asked to keep a log of at-home practice.
~Class sessions will consist of warm up (qi k'ong), postural and breathing exercises, Tai Chi form practice, and Tai Chi games (including push hands).
~Practice will consist of warm up, followed by practice of selected pieces of the form.
~Children on stimulant medications will remain on these medications during the training period (though they will be asked to stop medications one day prior to motor and cognitive testing pre-, mid- and postintervention)."
16090296|NCT02234544|Drug|Ezetimibe|The groups will be randomized to ezetimibe 10 mg for 5 days or placebo. On the fifth day, they should came after an overnight fast for blood tests collection [25(OH)D, PTH, calcium, albumin]. Next, all participants will receive orally a cholecalciferol 50,000 IU capsule and a snack containing 15g of fat. Participants will return 14 days after that for a second blood test.
16090297|NCT02234544|Drug|Cholecalciferol|All participants will receive orally a cholecalciferol 50,000 IU capsule and a snack containing 15g of fat. Participants will return 14 days after that for a second blood test.
16090336|NCT02234206|Drug|Chandrakanthi Choornam (CKC)|"12gm in milk - OD dose; Oral route; 3 Months ( 90days) - duration
~Preparation from approved sastric book as per drugs & cosmetic act 1940"
16090298|NCT02234544|Other|Placebo|The groups will be randomized to ezetimibe 10 mg for 5 days or placebo. On the fifth day, they should came after an overnight fast for blood tests collection [25(OH)D, PTH, calcium, albumin]. Next, all participants will receive orally a cholecalciferol 50,000 IU capsule and a snack containing 15g of fat. Participants will return 14 days after that for a second blood test.
16090299|NCT02234531|Device|EVER TEACHER|"The treatment will be performed in a darkened room, to avoid distraction provided by environmental stimuli. The patients will be seat on a standard chair in front of a wall screen handling a sensorized object with plegic hand. In case of grasping deficits the hand's surface will be used as end effector (i.e. sensorized glove worn by the patient). During the treatment a specific feedback called virtual teacher will be displayed. The Reinforced Feedback in Virtual Environment (RFVE) approach consists of performing different motor tasks moving the end effector simultaneously displayed in the virtual scenario. The Virtual Reality Rehabilitation System (VRRS®. Khymeia Group, Noventa Padovana. Italy) will be used as device to provide the artificial environment."
16090300|NCT02234531|Device|NEVER TEACHER|The patients allocated to NEVER TEACHER group, will be treated using the VRRS and the proceedings will be the same as described for experimental group. In this group, the patient will move the real object (e.g. ball) following the trajectory of the corresponding virtual object displayed on the wall screen in accordance with the requested virtual task and without the 'virtual teacher' support.
16090301|NCT02234518|Other|High quantity fiber|The intervention type is food product
16090302|NCT02234518|Other|Low quantity fiber|The intervention type is food product
16090303|NCT02234518|Other|Placebo|
16090304|NCT02234505|Procedure|Prosthetic alignment perturbation|Prosthetic ankle plantar-flexion will be modified in different degrees, devices (prosthetic components) will not be modified from baseline condition
16090305|NCT02234492|Drug|Rosuvastatin|Comparison of rosuvastatin to no rosuvastatin
16090306|NCT02234479|Biological|Hydrophor (Group A)|"Rehydrates dry, chapped or chafed skin
~May be used alone as a skin lubricant or protectant"
16090307|NCT02234479|Biological|MediHoney (Group B)|"It helps the body's natural healing processes in three key ways which have been shown to have healing benefits:
~Maintain a balanced environment for healing.
~Aids in reducing dermatitis.
~Reduce affected area pH.2-3"
16090308|NCT02234466|Drug|Oral dexamethasone|Patients will received their study drug ( or placebo) 2 hours pre-induction. Allowing for the shifting schedules of the OR with the possibility of the previous case finishing early or late, the allowable range is 90-200 minutes pre-induction.
16090309|NCT02234466|Drug|Ondansetron|Patients in both groups will receive 6mg IV ondansetron at time of skin closure as their standardized prophylaxis for postoperative nausea and vomiting.
16090310|NCT02234466|Other|Gelatin capsule|Gelatin capsule enclosing either dexamethasone tabs or second gelatin capsule
16090311|NCT02234453|Device|Minicare H-2000|Patients will use the Minicare H-2000 at home to measure their capillary blood count, temperature, record questionnaire results and transfer the results via the 3G network to the hospital team.
16090312|NCT02234440|Drug|Metformin|
16090313|NCT02234440|Drug|Insulin|
16090314|NCT02234427|Drug|Aspirin|2-week aspirin therapy (81mg/day)
16090315|NCT02234401|Device|Bi level pressure support|
16090316|NCT02234401|Other|Standard Care|
16090317|NCT02234388|Other|Observation|There are no interventions associated with this registry as it is purely observational.
16090318|NCT02234375|Drug|Gadolinium|agents will be administered intravenously and a CT scan will be performed to evaluate contrast enhancement characteristics of the agents to assess their feasibility as an alternative to Iodine based contrast agents
16090319|NCT02234362|Drug|vortioxetine|Eligible subjects will initiate the treatment with 5 mg/day for two days and then 10 mg/day starting on Day 3. The dosage may be increased from 10 mg/day to 15 mg/day at Visit 2 or Visit 3. At Visit 4, the dosage may again be increased from 10 to 15 mg/day or from 15 to 20 mg/day, based on patient response and tolerability.
16090320|NCT02234349|Procedure|pancreas kidney transplantation|
16090321|NCT02234349|Procedure|kidney transplantation|
16090322|NCT02234336|Procedure|Noncontrast echocardiography|
16090323|NCT02234336|Procedure|Contrast Echocardiography|
16090324|NCT02234336|Procedure|Cardiac magnetic resonance imaging|
16090325|NCT02234323|Biological|rFVIIIFc|Administered as specified in arm description
16090326|NCT02234310|Biological|rFIXFc|Adjustments to the dose and interval of rFIXFc was made in this study based on investigator discretion using available pharmacokinetic (PK) data, subsequent FIX trough and peak levels, level of physical activity, and bleeding pattern, in accordance with local standards of care for a prophylactic regimen. There was an option to start study dosing as episodic treatment (on-demand).
16090327|NCT02234297|Drug|BLZ-100|
16090328|NCT02234284|Behavioral|Health Coaching|Patient COPD education; Correct use of inhalers and nebulizers; Red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation; nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Identifying gaps in care, areas where care not in line with care plan; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Access to psychosocial services; Working with pulmonary specialist to provide recommended exercise program; Working with patient family members and caregivers.
16090329|NCT02234271|Other|Mobile Health Application|Mobile Health application for contraception information
16090330|NCT02234271|Other|Health Educator Counseling|Counseling via health educator
16090331|NCT02234258|Behavioral|Cognitive behavioral social skills|
16090332|NCT02234258|Behavioral|Psychoeducation|
16090333|NCT02234245|Device|Telemedicine System|Telemedicine System is used in remote monitoring group
16090334|NCT02234232|Behavioral|Exercise|Each exercise will be performed during the first 2.5 hours of the participant's hemodialysis session. Exercises are semi supervised: the kinesiologist will supervise the initial three exercise sessions, any session that requires a change to the exercise prescription and on a minimum of a weekly basis.
16090335|NCT02234219|Procedure|Heart-shape anastomosis|a new operation approach for Hirschsprung disease
16090382|NCT02233816|Biological|High dose of quadrivalent VLP vaccine|A single high dose of quadrivalent VLP vaccine
16090454|NCT02233244|Drug|Midazolam|
16090337|NCT02234193|Device|Micro biopsy|This is a prospective, self-controlled study of the healing response after collecting micro skin biopsies of different sizes (from 200 µm to 2 mm in diameter) from up to seven 1.5 x 1.5 cm biopsy sites in pre-abdominoplasty skin areas that are scheduled for surgical removal. The collection procedure will be performed using similar techniques as standard skin biopsies: the skin area involved will be cleaned with alcohol pads, and 1% buffered lidocaine with epinephrine anesthesia will be administered locally, then micro biopsies of skin will be removed by biopsy punch/harvesting needle. No more than 10% of the skin area within each biopsy site will be collected. Tattoo ink as described will be applied to 4 micro-biopsies at the corners of each biopsy test site
16090338|NCT02234193|Procedure|Lidocaine with epinephrine|The skin area involved will be cleaned with alcohol pads, and 1% buffered lidocaine with epinephrine anesthesia will be administered locally, prior to the surgical procedure
16090339|NCT02234180|Other|Placebo|Given PO
16090340|NCT02234180|Drug|Regorafenib|Given PO
16090341|NCT02234167|Behavioral|Risk behaviour and infectious diseases|through counselling, testing vaccination
16090342|NCT02234154|Device|TOPS System|Non-randomized study involving implantation of a TOPS via lumbar surgery to decompress and provide stability to the index level.
16090343|NCT02234141|Drug|Placebo|Tablet administered orally once daily
16090344|NCT02234141|Drug|Selonsertib|Tablets administered orally once daily
16090345|NCT02234128|Device|Toronto EVLP System™|Extending preservation and assessment time of donor lungs using the Toronto EVLP System
16090346|NCT02234115|Drug|Leuprolide Mesylate|Subcutaneous injection of 50mg Leuprolide Mesylate
16090347|NCT02234102|Device|Endoscopically guided laser ablation HeartLight system|
16090348|NCT02234089|Drug|Degarelix|According to medical practice
16090349|NCT02234089|Drug|LHRH agonist (Leuprorelinacetat, Goserelinacetat, Buserelinacetat, Triptorelinacetat)|According to medical practice
16090350|NCT02234076|Behavioral|VRET|
16090351|NCT02234076|Behavioral|TAU|Treatment as usual offered by the participating mental health care organisations
16090352|NCT02234063|Other|Immediate Genetic Testing|Participants will receive the APOL1 genetic test. Trained research staff will meet with participants to communicate results and lifetime ESRD risk attributable to variations in the APOL1 gene. Primary care providers will receive APOL1 genetic risk information via a best practice alert in the participant's EMR upon commencement of a patient encounter and through results filed in the participant's genetics results section of their EMR.
16090353|NCT02234050|Drug|Trabectedin|Trabectedin will be given as a 24-hour infusion every 3 weeks at a starting dose of 1.5 mg/m2 body surface area (BSA), until one of the treatment withdrawal criteria has been met.
16090354|NCT02234050|Other|Local standard of care|Left to the discretion of the investigator
16090355|NCT02234037|Drug|Decitabine|Decitabine will be administered intravenously at dose of 20mg/m² on 5 consecutive days every 28 days (1 cycle = 28 days) for a total of 2 cycles according to standard practice. Cycle 2 will proceed on time despite cytopenias, given that patients are not expected to be in remission after only 1 cycle of decitabine.
16090356|NCT02234037|Behavioral|Exercise|Each patient will participate in 2-3 exercise sessions per week supervised by a physical therapist. Each exercise session will comprise > 10 minutes of muscle strengthening, > 10 minutes of aerobic exercise (treadmill walking or cycling), > 10 minutes of stretching/range of motion exercises, and up to 10 minutes of individualized functional exercise (determined based on patient's reported deficits/targets in activities of daily living).
16090357|NCT02234024|Dietary Supplement|Supplementation of dairy-derived concentrated gangliosides.|
16090358|NCT02234011|Drug|Ketamine|
16090359|NCT02234011|Drug|Placebo|
16090360|NCT02233998|Other|Mouth Rinse 1|
16090361|NCT02233998|Other|Mouth Rinse 2|
16090362|NCT02233998|Other|Mouth Rinse 3|
16090363|NCT02233985|Drug|0.9% Sodium Chloride|Salbutamol 100 micrograms / kg / dose administered 0.9% saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.
16090364|NCT02233985|Drug|3% Sodium Chloride|Salbutamol 100 micrograms / kg / dose administered 3 % saline solution (4ml) nebulized for 3 initial sessions lasting 20 minutes each and every 4 hours during the entire hospital stay.
16090365|NCT02233972|Drug|Midazolam|
16090366|NCT02233972|Drug|Ginkgolides Meglumine Injection|
16090367|NCT02233972|Drug|placebo|
16090368|NCT02233946|Behavioral|computer-facilitated brief intervention|Immediate feedback to patient of screening results and risk for substance use problem, followed by 11 pages of science and true-life stories about health risks of adolescent substance use. Screening results then go to provider who reviews them with patient and gives brief counseling, and refers to an online motivational enhancement therapy intervention for patients at moderate/high risk for substance use problems.
16090369|NCT02233933|Other|Hemospray|hemospray is used after argon coagulation to stop bleeding
16090370|NCT02233920|Drug|Ventilat® - metered dose inhaler|
16090371|NCT02233907|Drug|Ventilat® - metered dose inhaler|
16090372|NCT02233894|Drug|Atrovent® - inhalets|
16090373|NCT02233881|Drug|Atrovent® - inhalets|
16090377|NCT02233842|Behavioral|Participant interview|People with cancer and who have survived cancer will have a 1 hour interview about using cigarettes and other tobacco products.
16090380|NCT02233816|Biological|Low dose of quadrivalent VLP vaccine|A single low dose of quadrivalent VLP vaccine
16090381|NCT02233816|Biological|Medium dose of quadrivalent VLP vaccine|A single medium dose of quadrivalent VLP vaccine
16090384|NCT02233803|Drug|NEUMOTEROL 400 (BFF 400/12 mcg) single capsule inhaler|Micronized 400 mcg budesonide+ 12 mcg formoterol fumarate along with micronized and crystalline lactose monohydrate (excipient), per capsule dispensed by single capsule inhaler, twice daily (administered once in the morning and once in the evening approximately 12 hours later).
16090385|NCT02233803|Drug|SYMBICORT forte (BFF 320/9mcg) TURBUHALER inhaler|Unit dose containing 320 mcg budesonide and 9 mcg formoterol fumarate (as dihidrate) along with lactose monohydrate as excipient. Administered as inhalation by TURBUHALER inhaler, twice daily (once in the morning and once in the evening approximately 12 hours later)
16090386|NCT02233803|Drug|NEUMOTEX 400 (Budesonide 400 mcg)|Budesonide 400mcg will be administered to all the subjects twice daily, during the Run-in and Washout Periods
16090387|NCT02233803|Drug|Salbutamol 100 mcg pMDI|Salbutamol 100mcg will be administered as pMDI on demand, as rescue medication, throughout the entire study period until Visit 5
16090388|NCT02233790|Drug|Ticagrelor|a loading dose of 180mg pre-PCI, and then 90 mg twice daily for 1 Month within the study. Thereafter, the patients will take clopidogrel if Ticagrelor is not available on the market.
16090389|NCT02233790|Drug|Clopidogrel|Clopidogrel 75 mg once daily after a loading dose of 300 mg pre-PCI.
16090390|NCT02233777|Drug|Pregabalin capsules 150 mg of Dexa Medica|Each capsule contains 150 mg of pregabalin. Test product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.
16090391|NCT02233777|Drug|Pregabalin capsules 150 mg of Pfizer Manufacturing Deutschland|Each capsule contains 150 mg of pregabalin. Reference product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.
16090392|NCT02233764|Other|FeZnPM|Iron and zinc biofortified pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
16090393|NCT02233764|Other|CtrlPM|Conventional pearl millet will be consumed three times per day, six days per week, for 9 months. Children are anticipated to consume 25-30 grams of the pearl millet at each feeding. The pearl millet will be prepared using a variety of recipes such as porridges, breads, and biscuits.
16090394|NCT02233751|Combination Product|Testosterone enanthate auto-injector|Randomization then administration of combination product study medication according to group assignment
16090395|NCT02233738|Behavioral|Group Motivational Interviewing (GMI)|Participants randomized to Group Motivational Interviewing (GMI) will receive four structured, back-to-back, 90-minute sessions consistent with the central principles and spirit of Motivational Interviewing (MI). GMI, which is based on a manualized protocol, is specifically designed for dually diagnosed Veterans. A focus of the intervention creates awareness of the relationship between the substance use and co-existing psychiatric disorder and the importance of treating both.
16090396|NCT02233738|Behavioral|Control Treatment Condition (CT)|"Control Treatment Condition (CT): Participants in CT will attend four sessions equal in time and length to GMI (i.e., 90 minutes) and will involve the following topics: A popular 'box activity': participants will anonymously write evocative questions on slips of paper involving their personal concerns that are placed in a box and, when randomly selected, opened for group discussion (e.g., How do I talk to my family about my alcohol problem?), money management with feedback (2 sessions), and cooking-home maintenance."
16090397|NCT02233725|Device|Definity Perflutren Injectable Suspension|a single dose of 10 μL/kg of the activated product by intravenous bolus injection over 30-60 seconds, followed by a 10 mL saline flush. If necessary, a second 10 μL/kg dose may be administered 5 minutes after the first injection to prolong contrast enhancement
16090398|NCT02233712|Biological|G17DT|
16090399|NCT02233699|Drug|XEN-D0501|
16090400|NCT02233699|Drug|Placebo|
16090401|NCT02233686|Drug|XEN-D0501|
16090402|NCT02233686|Drug|Placebo|
16090403|NCT02233673|Behavioral|Financial incentives|Participants receive a behavioral intervention and financial incentives for meeting gestational weight gain goals.
16090404|NCT02233660|Other|Physical Therapy Group|The physical therapy group will receive 3 treatment sessions of manual therapies including maneuvers targeted to the areas anatomically related to the median nerve (i.e., cervical spine, shoulder, elbow and wrist) of 30min of duration, once per week.
16090405|NCT02233660|Procedure|Surgical Group|The surgical group will receive a surgical procedure consisting of the decompression and release of the median nerve at the carpal tunnel performed by an experienced surgeon according to standardized protocols.
16090406|NCT02233647|Drug|Cocaine|The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and phendimetrazine.
16090407|NCT02233647|Drug|Placebo|The pharmacodynamic effects of placebo will be determined during maintenance on placebo and phendimetrazine.
16090408|NCT02233634|Drug|Oxygen|Oxygen is provided with a standard medical oxygen mask with reservoir (12L/min) for 3-5 min, assigned to both groups
16090409|NCT02233634|Other|Hyperventilation Breath-hold (HVBH)|1 Minute of Hyperventilation (25/min) is followed by a consecutive breath-hold for as long as the subject can comfortably tolerate. Both groups will perform this maneuver
16090410|NCT02233634|Other|HVBH with Oxygen|1 Minute of Hyperventilation (25/min) with an oxygen mask mounted (12L/min) is followed by a consecutive breath-hold for as long as the subject can comfortably tolerate. Both groups will perform this maneuver
16090411|NCT02233621|Other|[18F]FES (16α-[18F]Fluoro-17β-estradiol)|PET with [18F]FES before coelioscopy
16090412|NCT02233608|Behavioral|Advanced Pelvic Floor Muscle Exercise (APFX)|
16090413|NCT02233595|Radiation|Chemoradiation|
16090414|NCT02233582|Drug|Ibuprofen|We are simply testing if taking ibuprofen upon ascent to altitude is associated with a delayed acclimatization response to the high altitude hypoxia.
16090415|NCT02233582|Drug|Sugar pill|
16090416|NCT02233569|Procedure|Intraperitoneal onlay mesh (IPOM) repair with the use of Phisiomesh implant and Securestrap fixation device.|Laparoscopic intraperitoneal onlay mesh repair for abdominal wall hernia with the use of specially designed mesh and fixation device systems: Physiomesh (mesh implant) and Securestrap (fixation device)
16090417|NCT02233569|Procedure|Intraperitoneal onlay mesh (IPOM) repair with the use of Ventralight ST implant with SorbaFix fixation device.|Laparoscopic intraperitoneal onlay mesh repair for abdominal wall hernia with the use of specially designed mesh and fixation device systems: Ventralight ST (mesh implant) and SofbaFix (fixation device)
16090419|NCT02233569|Device|ETHICON PHYSIOMESH®|
16090420|NCT02233556|Drug|Memantine|"Taking 20mg(2 capsules) of memantine, followed by Event related potential assessments as below:
~Mismatch negativity(MMN)
~P50"
16090421|NCT02233543|Drug|QVA149|Delivered once daily via single-dose dry powder inhaler
16090422|NCT02233543|Drug|QVA149 Placebo|Placebo delivered once daily via single-dose dry powder inhaler
16090423|NCT02233530|Behavioral|CST intervention|The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life. Sessions will be led and facilitated by a study nurse or occupational therapist. The sessions will be held at a local health centre of village hall.
16090424|NCT02233517|Behavioral|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy provides patients with the skills to 1) identify and challenge maladaptive cognitions that are contributing to self-destructive behaviors; and 2) implement techniques such as relaxation training, communication skills, and relaxation training to address physiological and environmental barriers to effective functioning.
16090425|NCT02233517|Behavioral|Present Centered Therapy|"Present Centered Therapy utilizes interpersonal process, supportive techniques, identification of response options, encouragement of adaptive reactions, and focus on the here-and-now to support patients in their efforts to improve functioning."
16090426|NCT02233504|Drug|Exjade® (deferasirox, ICL670)|
16090427|NCT02233491|Behavioral|Active lifestyle intervention|Active intervention will comprise reviews by a renal dietician, with cognitive behaviour therapy, to provide additional support for lifestyle intervention.
16090428|NCT02233491|Other|Control|No additional support other than lifestyle advice by clinician
16090429|NCT02233478|Dietary Supplement|Pomegranate Juice|Pomegranate Juice alone
16090430|NCT02233478|Dietary Supplement|Soybean Flour Protein|Soybean Flour Protein combined with Pomegranate Juice
16090431|NCT02233478|Dietary Supplement|Soy Isolate Protein|Soy Isolate Protein combined with Pomegranate Juice
16090432|NCT02233465|Procedure|IPOM Mesh-repair parastomal hernia|Safety study for mesh-repair of parastomal hernia
16090433|NCT02233452|Drug|Methadone|The solution of methadone was prepared by mixing 10 ml of methadone (10 mg/ml) and 90 ml of saline 0.9% (Baxter, São Paulo, Brazil)
16090434|NCT02233452|Drug|Ketamine|The solution of ketamine was prepared by mixing 20 ml of S(+)-ketamine hydrochloride (50 mg/ml, Cristália®, São Paulo, Brazil) and 80 ml of saline 0.9% (Baxter, São Paulo, Brazil), obtaining a concentration of 10 mg/ml of ketamine.
16090435|NCT02233452|Drug|Methadone plus Ketamine|the solution of methadone, ketamine was prepared by mixing 10 ml of methadone hydrochloride (10 mg/ml, Cristália®, São Paulo, Brazil), 20 ml of S(+)-ketamine hydrochloride (50 mg/ml, Cristália®, São Paulo, Brazil) and 70 ml of saline 0.9% (Baxter, São Paulo, Brazil), obtaining a concentration of 1 mg/ml of methadone and 10 mg/ml of ketamine.
16090436|NCT02233439|Dietary Supplement|Herbal galactagogue|
16090437|NCT02233439|Dietary Supplement|Placebo|
16090438|NCT02233413|Device|Active LLLT helmet application|LED helmet applied with light activated
16090439|NCT02233413|Device|Non-active LLLT helmet application|LED helmet applied without light activated
16090440|NCT02233400|Drug|Acetaminophen|Group 1 (treatment) will receive IV acetaminophen (intervention drug) (1g in 100 ml of 0.9% normal saline IV Q 6hrs for 24 hours) plus IV narcotics (2-4 mg IV Q2hrs PRN) for the first 6 hours post-surgery followed by IV narcotics (2-4 mg IV Q2hrs PRN)/ PO narcotics (Oxycodone 5-10 ml PO Q4 hrs PRN) for the remaining 18 hours.
16090441|NCT02233387|Other|injection with [18F] HX4 and PET imaging|"A standard clinical [18F]FDG PET-CT will be performed for the radiotherapy planning.
~After a minimum time interval of 24 hours, baseline [18F]HX4 PET scans will be performed:
~Based on the phase I trial1 444 MBq (12 mCi) [18F]HX4 is administrated via a bolus IV injection.
~The first image acquisition is started together with the administration of [18F]HX4 (30-40 min dynamic). Static scans are acquired at 90 min, 180 min and 240 min p.i"
16090442|NCT02233374|Other|Early MRI and PET/CT - 2 weeks after commencing chemo/RT|Patients will have an early MRI and PET/CT - 2 weeks after commencing chemo/RT. A limited range PET/CT will look at parameters: SUVmaxm PERCIST, RECIST 1.1, ΔSUV (PET1-2), ΔSUV (early -late), Glycolytic tumour volume (GTV). MRI T2 (1-3mm slice as per NS Radiology protocol and ESGAR guideline) will look at parameters: DWI & ADC value (preferably on a single camera with reproducible ADC value), Local Staging, MRF involvement, EMVI, nodal status, MR volumetry, and desmoplastic reaction.
16090443|NCT02233374|Other|Late MRI and PET/CT 6 weeks post chemo/RT|Patients will have late a MRI and PET/CT 6 weeks post chemo/RT. A whole body PET/CT will look at parameters: SUVmaxm PERCIST, RECIST 1.1, ΔSUV (PET1-2), ΔSUV (early -late), Glycolytic tumour volume (GTV). MRI T2 (1-3mm slice as per NS Radiology protocol and ESGAR guideline) will look at parameters: DWI & ADC value (preferably on a single camera with reproducible ADC value), Local Staging, MRF involvement, EMVI, nodal status, MR volumetry, and desmoplastic reaction.
16090444|NCT02233361|Behavioral|Counseling|A randomized controlled design will determine whether hearing aid users who are informed in advance of a follow-up appointment have a different pattern of hearing aid use than a control group that is not preinformed in advance.
16090445|NCT02233322|Dietary Supplement|Iron|All subjects will receive iron supplementation based on iron levels in the blood
16090446|NCT02233309|Other|Monitoring of pressures during caudal anesthesia|The caudal itself is a separate procedure not covered by this observational study. This study simply attaches a monitoring device to the needle used for the caudal to measure pressures. The caudal takes place whether the observation of pressures is agreed to or not, as per standard protocol.
16090447|NCT02233296|Drug|Lasmiditan|2 discrete doses separated by 6 days.
16090448|NCT02233283|Other|Clamp|Volunteers will be submitted to hyperinsulinemic, euglycemic clamp studies of 10 hours duration.
16090449|NCT02233283|Other|Hypercaloric diet|Hypercaloric diet will be conducted during one month, and designed to provide 30% excess in calories compared to daily requirements. It will consist in a high fat, high carbohydrates diet.
16090450|NCT02233283|Other|Basal|Keeping the volunteers in the fasting state overnight and for the entire duration of the experiment (10 hours)
16090451|NCT02233283|Other|Isocaloric diet|Isocaloric diet will conducted for one month, and designed to provide the calculated daily energy needs
16090452|NCT02233257|Drug|Lorenzo's Oil|Oral use of Lorenzo's oil to lower very long chain fatty acids
16090455|NCT02233231|Drug|Varenicline|Varenicline 2 mg x 1 day 7 to week 12
16090456|NCT02233231|Drug|Placebo|similar tabl
16090457|NCT02233218|Drug|Telmisartan|
16090458|NCT02233218|Drug|Amlodipine|
16090459|NCT02233218|Drug|Rosuvastatin|
16090460|NCT02233205|Device|ultrasonic microbubbles|inject 1ml once and five times in 20min, locate the probe on the lesion at the same time
16090461|NCT02233205|Drug|platinum and gemcitabine|Chemotherapy drug of pancreatic carcinoma is gemcitabine. Chemotherapy drug of liver metastases is oxaliplatin and taxol.
16090462|NCT02233179|Device|Removable cast walker|Offloading device that can be removed by patients.
16090463|NCT02233179|Device|Irremovable cast walker|Offloading device that cannot be removed by patients.
16090464|NCT02233153|Other|Elder-Friendly Surgical Unit|
16090465|NCT02233140|Device|Extra-corporeal pulsed-activated therapy or shockwave therapy|
16090466|NCT02233114|Other|Yogic exercises|Yogic exercises (YE) - 2 hours per week, 1h in each session
16090467|NCT02233114|Other|Physiotherapy|Physiotherapy (low intensity cardiovascular training and strength training) - 2 hours per week, 1 h in each session
16090468|NCT02233101|Drug|Oral Tranexamic Acid|patients will receive 1950mg of oral prior to surgery to help reduce blood loss during total joint replacement
16090469|NCT02233101|Drug|Intravenous Tranexamic Acid|Patients will receive 1950mg of intravenous Tranexamic Acid prior to total joint arthroplasty and blood loss or need for transfusion within 24 hours post operative
16090470|NCT02233088|Behavioral|ELM Group|"ELM participants are trained to portion their meals according to the Perfect Plate method, a modified version of the USDA's ChooseMyPlate.gov. The stress management focuses on mindful living, cognitive restructuring; the enhancement of positive emotions. The physical activity component focuses on reduction of sedentary activity (by increasing daily step counts) and moderate-to-vigorous physical activity."
16090471|NCT02233088|Other|ELM Classes|ELM classes will be administered through Rush Generations program and focus on health education.
16090472|NCT02233088|Other|ELM Individual|ELM Individual arm participants will receive education materials on metabolic syndrome and diet, exercise, stress reduction recommendations. The participants will be recommended to follow these guidelines and discuss/seek support from their health care provider (visits at baseline, 3 and 6 months will be recommended.
16090473|NCT02233075|Drug|REP 2139-Ca + Pegasys (TM)|15 weeks of REP 2139-Ca (500mg QW IV) followed by: 15 weeks of REP 2139-Ca (250mg QW IV) + Pegasys(TM) (180 ug QW SC) followed by: 33 weeks of Pegasys(TM) (180 ug QW SC)
16090474|NCT02233062|Dietary Supplement|Exclusive Enteral Nutrition Therapy|
16090475|NCT02233049|Drug|Erlotinib|
16090476|NCT02233049|Drug|Everolimus|
16090477|NCT02233049|Drug|Dasatinib|
16090478|NCT02233023|Drug|Pramipexole|
16090479|NCT02233023|Drug|Bromocriptine and other dopamine agonists|
16090480|NCT02233010|Other|The level of NGAL after pre op,post op 4hr, post op 12hr|
16090481|NCT02232997|Other|Long Hydration|The hydration with sodium chloride was set 12 hours before the procedure (before contrast exposure during coronary angiography), continued for the duration of the procedure, and for 12 hours post-procedure at the speed of 1ml/kg/hr (0.5ml/kg/hr for patients with congestive heart failure, New York Heart Association class III or LVEF<35%). For patients who weighed more than 80 kg, the bolus and infusion rate were limited to those calculated for patients weighing 80 kg.
16090482|NCT02232997|Other|Short Hydration|The hydration with sodium chloride was set 1 hour before the procedure (before contrast exposure during coronary angiography), continued for the duration of the procedure, and for 4 hours post-procedure at the speed of 3ml/kg/hr (1.5ml/kg/hr for patients with congestive heart failure, New York Heart Association class III or LVEF<35%). For patients who weighed more than 80 kg, the bolus and infusion rate were limited to those calculated for patients weighing 80 kg.
16090483|NCT02232971|Drug|Glucagon|Glucagon is given in three different doses according to three research days.
16090484|NCT02232971|Other|Isotonic saline solution|Placebo
16090485|NCT02232958|Other|Hyperbaric Oxygen Treatment|Patients are placed in a special chamber in which the pressure is gradually increased up to the desired pressure with 100% Oxygen and the patient is kept at that pressure for one hour. Then the Oxygen flow is slowly reduced until the patient has been returned to one atmosphere of pressure.
16090486|NCT02232945|Drug|placebo of oseltamivir phosphate|
16090487|NCT02232945|Drug|oseltamivir phosphate|
16090488|NCT02232945|Drug|Banlangen (Radix Isatidis) granules|
16090489|NCT02232945|Drug|placebo of Banlangen(Radix Isatidis) granules|
16090490|NCT02232932|Procedure|CAPECITABINE-Radiotherapy -Liver Transplantation|CAPECITABINE (800 mg/m2 twice a day during 5 weeks) + External Radiotherapy (50 grays during 5 weeks) then Liver transplantation
16090491|NCT02232932|Procedure|RESECTION|Intent-to-treat R0 liver resection
16090492|NCT02232919|Device|Deep Brain Stimulation|"If subjects qualify with respect to protocol requirements, the Medtronic Activa system will be implanted with the leads placed bilaterally in the VMH.
~Adjustment of DBS parameters at the three months visit will be performed to improve efficacy when the goal of 3% body weight loss mark was not achieved during this period of continuous stimulation. Subjects will be seen monthly after discharge throughout the study period. At visits, safety will be assessed through blood/urine tests, blood pressure measurements, verbal interviews with the subjects and family, quarterly formal psychiatric tests as well as QOL scales.
~The determination of efficacy will be the within-group percent change in weight at the end of the DBS treatment period compared to baseline."
16090493|NCT02232906|Drug|intravenous ferric carboxymaltose|Ferric carboxymaltose (FCM) dose of 1,000 mg iron, followed by a 6-month ESA/FCM maintenance regimen (target: Hemoglobin 120 g/L, transferrin saturation >20%)
16090494|NCT02232893|Drug|Daikenchuto (TU-100)|Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and for 28 days after surgery.
16090495|NCT02232893|Drug|Placebo|Subjects will receive daily dose of TU-100 placebo. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 3 days before surgery and for 28 days after surgery.
16090534|NCT02232542|Drug|Duloxetine - low dose|
16090535|NCT02232542|Drug|Duloxetine - high dose|
16090536|NCT02232542|Drug|Placebo|
16090537|NCT02232529|Drug|MIN-101|
16090538|NCT02232529|Drug|Placebo|
16090496|NCT02232880|Drug|Abatacept|All subjects will be treated with chlorthalidone 25 mg/day, lisinopril 20 mg/day [Patients with a history of adverse reaction to lisinopril will be treated with losartan 50 mg/day], amlodipine 5 mg/day and spironolactone 25 mg bid as standardized treatment of hypertension prior to randomization and throughout the active treatment phase.
16090497|NCT02232880|Drug|Placebo|All subjects will be treated with chlorthalidone 25 mg/day, lisinopril 20 mg/day [Patients with a history of adverse reaction to lisinopril will be treated with losartan 50 mg/day], amlodipine 5 mg/day and spironolactone 25 mg bid as standardized treatment of hypertension prior to randomization and throughout the active treatment phase.
16090498|NCT02232867|Behavioral|Arm and Leg Cycling Exercise Program|Participants will perform arm and leg cycling training three times a week, with 30 minutes of aggregate exercise time per session. To evaluate the physiological cost of exercise, heart rate and a rating of perceived exertion will be collected. The progressive element of this training will include increasing the resistance of the ergometer over the six weeks in order to maintain the same relative exercise stress.
16090499|NCT02232854|Behavioral|Depression training/supervision program|"The intervention will be composed of:
~Training of Primary Health Care teams to ensure compliance to the Clinical Guidelines of the Ministry of Health for the Treatment of Depression. Primary Health Care teams will undergo an Objective Structured Clinical Examination (OSCE) for evaluation.
~After the training, a focus group between Primary Health Care teams and study researchers will be held in order to address barriers to clinical guidelines implementation.
~Primary Health Care clinics' trained administrative staff will contact patients from a call-center to support treatment adherence.
~Psychiatrists, using a web-based platform, will supervise the course of the program, the allocated treatments, the patients' progress, and their response to treatment."
16090500|NCT02232841|Device|Mechanical Ventilation|Subjects will receive mechanical ventilation as part of their standard of care, as specified in the enrollment criteria
16090501|NCT02232841|Device|CT Scan|Subjects will receive a CT scan as part of their standard of care, as specified in the enrollment criteria
16090502|NCT02232828|Procedure|Selective removal|Caries removal in the periphery including the enamel-dentinal junction will be performed using rose head burs and/or an excavator until hard, dry dentin remains. Pulpo-proximal caries will be removed until leathery, slightly moist and reasonably soft dentin remains. Operating dentists will be calibrated prior to study commencement regarding these criteria using extracted teeth. Moisture control will be performed using cotton rolls and continuous aspiration. Restoration will be performed adhesively, with a self-etching one-bottle adhesive (G-aenial bond, GC, Bad Homburg, Germany) and a compomer material (Dyract, Dentsply Detray, Konstanz, Germany) being used.
16090503|NCT02232828|Procedure|Stepwise removal|"Caries removal in the periphery including the enamel-dentinal junction will be performed using rose head burs and/or an excavator until hard, dry dentin remains. Pulpo-proximal caries will be removed until leathery, slightly moist and reasonably soft dentin remains. Operating dentists will be calibrated prior to study commencement regarding these criteria using extracted teeth. Moisture control will be performed using cotton rolls and continuous aspiration. Restoration will be performed adhesively, with a self-etching one-bottle adhesive (G-aenial bond, GC, Bad Homburg, Germany) and a compomer material (Dyract, Dentsply Detray, Konstanz, Germany) being used.
~If allocated to stepwise excavation, the second excavation will now be performed as described until only hard, dry dentin remains. Restoration will again be provided adhesively as described."
16090504|NCT02232802|Drug|Enoxaparin Sodium|comparison of bioavailability of generic Enoxaparin Sodium and Clexane
16090505|NCT02232802|Drug|Enoxaparin Sodium|comparison of bioavailability of generic Enoxaparin Sodium and Clexane
16090506|NCT02232789|Drug|Mephedrone|Single oral dose mephedrone
16090507|NCT02232789|Drug|3,4-methylenedioxymethamphetamine|Single oral dose MDMA
16090508|NCT02232789|Drug|Placebo|Single oal dose placebo
16090509|NCT02232776|Drug|Losartan|Dose of Losartan : 0.7mg/kg once daily.
16090510|NCT02232763|Drug|Losartan|12 weeks of losartan or placebo with crossover to the other
16090511|NCT02232763|Drug|Placebo|12 weeks of losartan or placebo with crossover to the other
16090512|NCT02232737|Other|Very low nicotine content cigarettes|
16090513|NCT02232724|Device|Choline PET/CT and Dual time point FDG PET/CT|Choline PET/CT and dual time point FDG PET/CT
16090514|NCT02232698|Device|Sensor Based Glucose Monitoring System|"Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels.
~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
16090515|NCT02232698|Device|Standard Blood Glucose Monitoring|"Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 3 and 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study (Sensor glucose measurements not visible during this time).
~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation (Sensor glucose measurements not visible during this time)."
16090516|NCT02232685|Device|18F-Choline PET/CT|18F-Choline PET/CT
16090517|NCT02232672|Device|Choline PET/CT and MeAIB PET/CT|Choline PET/CT and MeAIB PET/CT
16090518|NCT02232659|Device|70cc TAH-t for Destination Therapy|Use of the approved SynCardia 70cc TAH-t for patients who are in biventricular failure (approved use), but who are ineligible for cardiac transplant (experimental use).
16090519|NCT02232646|Drug|BBI503|BBI503 will be administered orally, daily, in continuous 28-day cycles at a dose of 300 mg once daily.
16090520|NCT02232633|Drug|BBI503|
16090521|NCT02232620|Drug|BBI503|BBI503 will be administered orally, daily, in continuous 28-day cycles at a dose of 300 mg once daily.
16090522|NCT02232607|Drug|Lacidipine, low dose|
16090523|NCT02232607|Drug|Lacidipine, medium dose|
16090524|NCT02232607|Drug|Lacidipine, high dose|
16090525|NCT02232607|Drug|Placebo|
16090526|NCT02232594|Drug|Berodual®|
16090527|NCT02232581|Drug|Alovudine - low|
16090528|NCT02232581|Drug|Alovudine - medium|
16090529|NCT02232581|Drug|Alovudine - high|
16090530|NCT02232581|Drug|Placebo|
16090531|NCT02232568|Behavioral|Feedback|
16090532|NCT02232555|Drug|Duloxetine|
16090533|NCT02232555|Drug|Placebo|
16090539|NCT02232516|Drug|romidepsin|Given IV
16090540|NCT02232516|Drug|lenalidomide|Given PO
16090541|NCT02232516|Other|laboratory biomarker analysis|Correlative studies
16090542|NCT02232503|Genetic|Studied cohort|For the purpose of DNA isolation prior to genetic analysis of patients two samples of peripheral blood will be taken; first in the volume of 3.5 ml and second in the volume of 9 ml from each patient included into the study.
16090543|NCT02232490|Biological|hepcortespenlisimut-L|hepcortespenlisimut-L (V5) is given in experimental arm
16090544|NCT02232490|Biological|Placebo|
16090545|NCT02232477|Drug|Intrathecal recombinant human alpha iduronidase|Intrathecal recombinant human alpha iduronidase every 3 months
16090546|NCT02232451|Device|ERCP with loop tip wire|Endoscopic retrograde cholangio-pancreatography with guide wire (loop-tip) for CBD cannulation
16090547|NCT02232451|Device|ERCP for cannulation|Endoscopic retrograde cholangio-pancreatography with traditional technique for CBD cannulation
16090548|NCT02232438|Behavioral|Behavioral activation therapy|Behavioral activation therapy (BAT) is a brief, manualized therapy that has shown efficacy in the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in several controlled trials patients (see review in Dimidjan et al., Ann Rev Clin Psychol, 2010, and Chu, Brian C., et al. Cognitive and Behavioral Practice, 2009.), including adult cancer patients (Hopkoet al., 2009; Hopko et al., 2011).
16090549|NCT02232425|Drug|IX-01|
16090550|NCT02232425|Drug|Placebo|
16090551|NCT02232399|Drug|Levosimendan|The drug infusion will be started after initiation of cardiopulmonary bypass and will continue for 24 hours.
16090552|NCT02232399|Drug|Milrinone|The drug infusion will be started after initiation of cardiopulmonary bypass and will continue for 24 hours.
16090553|NCT02232386|Drug|Ibrutinib|Ibrutinib (PCI-32765) 420 mg (3 x 140 mg capsules) will be administered orally once daily. The first dose will be delivered in the clinic on Day 1, after which subsequent dosing is typically on an outpatient basis.
16090554|NCT02232386|Drug|Rituximab|Rituximab 375 mg/m2 iv. Month 1: day 1 of weeks 1, 2, 3, 4; months 2-6: day 1of week 1.
16090555|NCT02232373|Behavioral|low FODMAP dietary advice|An education session with a specialist dietitian, and provision of written advice, on how to follow the low FODMAP diet. Second session after one month on re-introduction of FODMAP containing foods.
16090556|NCT02232373|Dietary Supplement|Maltodextrin|Dietary supplementation with maltodextrin 5 grams twice daily for a month
16090557|NCT02232373|Dietary Supplement|Oligofructose|Dietary supplementation with oligofructose 5 grams twice daily for a month
16090558|NCT02232360|Drug|Rosuvastatin and fenofibrate|Combination therapy: rosuvastatin 10 mg and fenofibrate 160 mg per day
16090559|NCT02232360|Drug|Rosuvastatin alone|Rosuvastatin 10mg per day
16090560|NCT02232347|Drug|Ketamine|
16090561|NCT02232347|Drug|Sufentanil|
16090562|NCT02232334|Other|Global Osteopathic Manual Treatment|subtle manipulations of the body according to the methodology of osteopathic manual therapy will be the intervention on subjects in the study. The global treatments will take into consideration the past medical history of each subject as well as what is found on assessment. Focus is on the position, mobililty and quality of each subjects anatomy.
16090563|NCT02232321|Other|PsA MDA|
16090564|NCT02232308|Drug|Nizatidine|Nizatidine (150 mg) will be administered once daily for the first 3 days, then twice daily for days 4-9, and once on day 10.
16090565|NCT02232308|Drug|Lisinopril|Lisinopril (10 mg) will be administered once daily for the first 3 days, then twice daily for days 4-9, and once on day 10.
16090566|NCT02232308|Drug|Placebo|Placebo capsules to match active drug will be administered once daily for the first 3 days, then twice daily for days 4-9, and once on day 10.
16090567|NCT02232295|Device|Recognise [TM]|Recognise accurately measures to identify left and right body parts and movements, and to train left/right discrimination as part of a comprehensive GMI rehabilitation process.
16090568|NCT02232295|Device|Mirror Box|A resource used for many pain and disability states of the hands and feet.
16090569|NCT02232282|Device|standard acupuncture treatment|A standardized acupuncture treatment will be assigned, and both groups will receive 7 acupuncture treatments that follow a standardized protocol on classical acupuncture points, with or without mild electrical stimulation versus sham/minimal acupuncture. Acupuncture needles are single use, sterile and disposable. Standard acupuncture treatment protocol will include 4 gates plus GV 20 to reduce anxiety and help with relaxation and to assess acupuncture naïve patient's response to needles during their first acupuncture encounter. Subsequent visits would include administration of curious meridian Chong Mo paired with Yang Ming. 4 Hz low level electrical stimulation will be applied.
16090570|NCT02232282|Device|Control Sham/Minimal Acupuncture|"Control group will receive sham/minimal acupuncture with low level electrical stimulation. The sham intervention (also described as minimal intervention) will use superficial needle insertion at body locations not recognized as true acupoints. Patients will be explained that various acupuncture treatment protocols will be tested including minimal acupuncture, therefore, the control group will not be aware of receiving sham acupuncture. These described acupuncture treatments are well accepted treatment protocols for women with pelvic pain and bladder complaints."
16090571|NCT02232269|Other|Black Coffee|
16090572|NCT02232269|Other|Grapefruit Juice|
16090573|NCT02232269|Other|Water|
16090574|NCT02232269|Drug|Felodipine|
16090575|NCT02232256|Drug|CALPXT96|Arm 1: intervention begins with CALPXT96 Arm 2: intervention begins with placebo
16090576|NCT02232243|Drug|Hydroxychloroquine, 200mg twice dailiy|Hydroxychloroquine, 200mg twice daily (400mg/day total) was given to subjects for up to 14 days prior to surgery.
16090577|NCT02232243|Drug|Hydroxychloroquine, 400mg twice daily|Hydroxychloroquine, 400mg twice daily (800mg/day total) was given to subjects for up to 14 days prior to surgery.
16090578|NCT02232230|Drug|Provenge|
16090579|NCT02232217|Behavioral|Cognitive Behavior Therapy Sleep|Children in this arm will receive instructions on the use of 'coping thoughts.' Common elements across the CBTcs sessions include reviewing progress, setting goals for change, problem solving to address challenges/barriers, and reinforcing progress
16090580|NCT02232217|Other|Education Control|Children in this arm will receive sleep and dietary education, as well as general coping strategies and controls for staff attention and seasonal effects that could influence changes in sleep and health outcomes.
16090581|NCT02232204|Behavioral|CBT for Insomnia in ICD Patients (CBT-I-ICD)|Participants will complete 4 weekly therapy sessions focused on improving sleep and reducing ICD-related stress. A multicomponent CBT-I-ICD (Cognitive Behavioral Therapy for Insomnia in ICD Patients) protocol will involve: sleep hygiene, stimulus control, sleep restriction, relaxation, cognitive restructuring, ICD education and recall information, shock planning, and quality of life-improvement recommendations.
16090582|NCT02232191|Biological|Pneumovax-23|
16090583|NCT02232178|Drug|2 100mg Xaracoll implants|
16090584|NCT02232178|Drug|3 100mg Xaracoll implants|
16090585|NCT02232178|Drug|150mg Bupivacaine HCl injection|
16090586|NCT02232165|Other|Hypotension avoidance|Induced hypertension with MAP >= 85 mmHg for 7 days following SCI is the current recommended clinical option guideline. Our intervention tests whether hypotension avoidance and maintenance of MAP >= 65 mmHg is not inferior to induced hypertension.
16090587|NCT02232165|Other|Induced hypertension|Induced hypertension with MAP >= 85 mmHg for 7 days following SCI is the current recommended clinical option guideline.
16090588|NCT02232152|Drug|6,8-bis(benzylthio)octanoic acid|Given IV
16090589|NCT02232152|Drug|fluorouracil|Given IV
16090590|NCT02232152|Other|pharmacological study|Correlative studies
16090591|NCT02232152|Other|laboratory biomarker analysis|Correlative studies
16090592|NCT02232139|Drug|Midazolam|The participants receive the pharmacological premedication before the surgery anyway
16090593|NCT02232126|Other|SWIFT home intervention|1 in-home assessment performed by study social worker, another in-home visit performed if needed. Up to 4 telephone contacts performed by study social worker. A maximum of 6 contacts
16090594|NCT02232113|Drug|CERA|changing frequency of administration from once to twice monthly under a fixed total monthly dose of CERA
16090595|NCT02232100|Behavioral|Attentional bias modification training (AMG)|Attentional bias modification, administered via an internet-delivered visual-probe task that trains attention away from pain-related information
16090596|NCT02232100|Behavioral|Attentional bias placebo (ACG)|Attentional bias placebo, administered via an internet-delivered visual-probe task that does not train attention either away or towards pain-related information
16090597|NCT02232087|Drug|Salmeterol|A, D 2 puffs; B, E 6 puffs; C, F 12 puffs
16090598|NCT02232087|Drug|fluticasone propionate|A, D 2 puffs; B, E 6 puffs; C, F 12 puffs
16090599|NCT02232074|Other|Patient navigation enhanced with legal support|
16090600|NCT02232061|Drug|Fingolimod|Fingolimod 0.5 mg tablet
16090601|NCT02232048|Other|Transthoracic Echocardiogram|
16090602|NCT02232035|Drug|normal saline/diazepam at the active phase of labor|A single dose intravenous injection of normal saline (2ml)/diazepam (10mg, 2ml) at the beginning of active phase of labor.
16090603|NCT02232022|Device|Reveal LINQ Insertable Cardiac Monitor|
16090604|NCT02232009|Device|3.0 T Neonatal MRI Scanner|Eligible subjects will undergo neonatal MRI scanning procedures.
16090605|NCT02231983|Genetic|gene sequencing|Amplify and identify exons from gene IL-2RG by PCR and agarose gel electrophoresis, and then followed by gene sequencing.
16090606|NCT02231970|Procedure|Endoscopic sleeve gastroplasty|To perform endoluminal gastric volume reduction by the Endoscopic sleeve gastroplasty
16090607|NCT02231957|Other|educational text message reminders|
16090608|NCT02231957|Other|conventional text message reminders|
16090609|NCT02231944|Biological|Replenine®-VF (High Purity Factor IX)|
16090610|NCT02231931|Drug|Digoxin|single dose, fasted
16090611|NCT02231931|Drug|Rosuvastatin|single dose, fasted
16090612|NCT02231931|Drug|Digoxin, Furosemide, Metformin hydrochloride, Rosuvastatin|fasted
16090613|NCT02231931|Drug|Digoxin, Furosemide, Metformin hydrochloride, Rosuvastatin|fasted
16090614|NCT02231931|Drug|Metformin hydrochloride|single dose, fasted
16090615|NCT02231931|Drug|Digoxin, Furosemide, Metformin hydrochloride, Rosuvastatin|fasted
16090616|NCT02231931|Drug|Furosemide|single dose, fasted
16090617|NCT02231918|Drug|MIRAPEX® - low|
16090618|NCT02231918|Drug|MIRAPEX® - medium|
16090619|NCT02231918|Drug|MIRAPEX® - high|
16090620|NCT02231905|Drug|BI-Sifrol®|
16090621|NCT02231892|Device|TMS|HAC coil (real rTMS or sham rTMS)
16090622|NCT02231879|Drug|Plerixafor|Twice daily low dose injection for 14 months.
16090623|NCT02231879|Drug|G-CSF|Twice daily low dose injection for 14 months.
16090624|NCT02231866|Biological|VRC-EBOADC069-00-VP|cAd3-EBO Ebola Chimpanzee Adenovirus Vector Vaccine GP Zaire + GP Sudan
16090625|NCT02231866|Biological|VRC-EBOADC076-00-VP|cAd3-EBO Ebola Chimpanzee Adenovirus Vector Vaccine GP Zaire
16090626|NCT02231853|Biological|MVST|MVST Infusion
16090627|NCT02231853|Biological|MVSTr|"PBMCs will be collected by apheresis prior to mobilization for Hematopoietic stem cells collection, donor apheresis will be used partially to prepare DLIs per PI specification and remaining will be further processed by elutriation.
~Monocytes and Lymphocytes are cryopreserved for further manufacture of MVSTr."
16090628|NCT02231827|Other|Gait analysis|Subjects, barefoot and standing upright and motionless on a force plate, were instructed to walk for 10 m following a beep delivered by the experimenter. Two experimental conditions were tested: (i) the 'natural' gait condition where subjects walked normally and (ii) the 'fast' gait condition where subjects walked as fast as they could, taking large steps. Each subject performed 10 trials in each condition.
16090629|NCT02231814|Dietary Supplement|Crohns Disease Exclusion Diet + PEN|"Patients will use the CDED for a 24 week period, coupled with 1000 ml of polymeric formula (1 Kcal/mL) for the first 6 weeks. For weeks 7 to 24 patients will use the CDED coupled with 600 ml formula and a calcium supplement. The CDED is divided into 3 stages: 0-6 weeks induction phase, weeks 7-12 step down phase, weeks 13-24 maintenance phase."
16090630|NCT02231814|Other|Crohns Disease Exclusion Diet|Crohn's Disease Exclusion Diet alone with a calcium supplement during the study (0-24). The CDED is divided into 3 stages: 0-6 weeks induction phase, weeks 7-12 step down phase, weeks 13-24 maintenance phase.
16090631|NCT02231801|Behavioral|Mother-Infant Dyad|Skin-to-skin holding of preterm infants by their mothers
16090632|NCT02231788|Drug|Telminuvo®Tab. 40/2.5mg|Telminuvo®Tab. 40/2.5mg, Once daily, Per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg
16090679|NCT02231502|Other|Vegetable-based convenience food|
16090680|NCT02231502|Other|Vegetable meal|
16090633|NCT02231788|Drug|Telmitrend®Tab. 80mg|Telmitrend®Tab. 80mg, Once daily, Per oral for 8weeks after 2~4weeks run-in period with Telmitrend®Tab. 40mg
16090634|NCT02231775|Drug|Dabrafenib|Given PO
16090635|NCT02231775|Other|Laboratory Biomarker Analysis|Correlative studies
16090636|NCT02231775|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16090637|NCT02231775|Drug|Trametinib|Given PO
16090638|NCT02231762|Drug|Lanreotide Autogel 120 mg|Lanreotide Autogel 120 mg subcutaneous (s.c) - injection, every 28 days (+/-2 days).
16090639|NCT02231762|Drug|Temozolomide (TMZ)|Temozolomide capsule (variable dose). 150 mg/m2 per day for 5 days in the first month. 200 mg/m2 per day for 5 days in months 2, 3, 4, 5 and 6.
16090643|NCT02231723|Drug|BBI608|Administered continuously twice daily with doses separated by 12 hours
16090644|NCT02231723|Drug|Nab-paclitaxel|Nab-paclitaxel 125 mg/m^2 I.V. infusion on Days 1, 8, and 15 of every 28-day cycle
16090645|NCT02231723|Drug|Gemcitabine|Gemcitabine 1000 mg/m^2 I.V. infusion on Days 1, 8, and 15 of every 28-day cycle
16090646|NCT02231723|Drug|Oxaliplatin|Oxaliplatin 85 mg/m^2 I.V. infusion on Days 1 and 15 of every 28-day cycle
16090647|NCT02231723|Drug|Leucovorin|Arm C, D: Leucovorin 400 mg/m^2 I.V. infusion on Days 1 and 15 of every 28-day cycle
16090648|NCT02231723|Drug|Irinotecan|Arm B: Irinotecan 165 mg/m^2 I.V. infusion on Days 1 and 15 of every 28-day cycle, Arm C: Irinotecan 165 mg/m^2 I.V. infusion on Days 1 and 15 of every 28-day cycle
16090649|NCT02231723|Drug|Fluorouracil|Arm B, D: Fluorouracil 2400 mg/m^2 I.V. infusion on Days 1 and 15 of every 28-day cycle, Arm C: Fluorouracil 400 mg/m^2 I.V. bolus followed by 2400 mg/m^2 I.V. infusion on Days 1 and 15 of every 28-day cycle
16090650|NCT02231723|Drug|MM-398|MM-398 70 mg/m^2 I.V. infusion on Days 1 and 15 of every 28-day cycle
16090651|NCT02231710|Biological|BPX-501 and Rimiducid|Single administration of BPX-501 T cells post partially-mismatched, related T cell depleted HCT followed by Rimiducid infusion on day 7
16090652|NCT02231697|Other|Non-interventional, retrospective medical chart review|Non-interventional, retrospective medical chart review
16090653|NCT02231684|Drug|semaglutide|Semaglutide administered subcutaneously (s.c. under the skin) in two out of three different strengths (1mg/mL, 3mg/mL and 10 mg/mL).
16090654|NCT02231684|Drug|semaglutide|Semaglutide administered subcutaneously (s.c. under the skin) in two out of three different strengths (1mg/mL, 3mg/mL and 10 mg/mL) or intravenously (i.v.) (1mg/mL).
16090655|NCT02231671|Drug|ALS-008176|
16090656|NCT02231671|Drug|ALS-008112|
16090657|NCT02231658|Drug|Liraglutide|
16090658|NCT02231658|Drug|Lixisenatide|
16090659|NCT02231645|Device|STN DBS|The DBS device is turned on and off by the physician.
16090660|NCT02231632|Biological|Live attenuated Poliomyelitis vaccine (Human Diploid Cell)|6.15 lgCCID50 /Vial, 0.1ml/dose(10 dose /Vial) in babies aged 2-3 months, three dose(4 weeks'interval for each Intervention).
16090661|NCT02231632|Biological|Live attenuated Poliomyelitis vaccine (Monkey Kidney Cell)|6.15 lgCCID50 /Vial, 0.1ml/dose(10 dose /Vial) in babies aged 2-3 months, three dose(4 weeks'interval for each Intervention).
16090662|NCT02231619|Behavioral|Baseline verbal instruction on LSUPT|
16090663|NCT02231606|Other|Free Glasses|Provide free glasses
16090664|NCT02231606|Other|Upgrade Glasses 1|Provide optional purchase from range of spectacles, cheapest RMB100 (Mean price paid for glasses by Control families in Seeing is Learning I, subtracting one SD)
16090665|NCT02231606|Other|Upgrade Glasses 2|Provide optional purchase from range of spectacles, cheapest RMB200 (Mean price paid for glasses by Control families in Seeing is Learning I, adding one SD)
16090666|NCT02231593|Other|SAGIT|SAGIT is a Clinician-Reported Outcomes (ClinROs) tool
16090667|NCT02231580|Drug|BN82451B|BN82451B capsule
16090668|NCT02231580|Drug|Placebo|Placebo capsule
16090669|NCT02231567|Other|Neurocognitive Rehabilitation|The patients will be treated in inpatient clinic with a neurocognitive rehabilitation approach. The frequency will be two times a day for six days a week for four consecutive weeks. Followed by outpatient treatment three times a week for four weeks. Each session lasts about one hour.
16090670|NCT02231567|Other|Traditional Rehabilitation|The patients will be treated in inpatient clinic with a traditional rehabilitation approach. The frequency will be two times a day for six days a week for four consecutive weeks. Followed by outpatient treatment three times a week for four weeks. Each session lasts about one hour.
16090671|NCT02231554|Other|Feldenkrais Method|The program of Awareness Through Movement ® chosen for this study, teaches the basic movements of the column. The aim is to stimulate changes in the chronic pathological patterns and in the distorted kinesthetic perceptions that so often hinder the rehabilitation of chronic non-specific low back pain. The patients will be treated in outpatient with the Feldenkrais method. Each group will consist of four or five patients who carry out the rehabilitation treatment with a frequency of twice a week for five consecutive weeks for a total of 10 sessions, each lasting about one hour.
16090672|NCT02231554|Other|Back School|The rehabilitation program of Back School is divided into two parts: one theoretical and one practical. To obtain an effective action not only in reducing pain but also in preventing relapse, the Back School acts on the typical risk factors of chronic non-specific low back pain, such as incorrect postures and movements, psychological stress, poor physical fitness, overweight, obesity, smoking, and insufficient knowledge of the spine. The patients will be treated in outpatient with a Back School program. Each group will consist of four or five patients who carry out the rehabilitation treatment with a frequency of twice a week for five consecutive weeks for a total of 10 sessions, each lasting about one hour.
16090673|NCT02231541|Device|Very Low Frequency Magnetic Fields|The device is set to an analgesic program lasting about 30 minutes.
16090674|NCT02231541|Device|Very Low Frequency Magnetic Fields|The device is turned off.
16090675|NCT02231528|Device|Use of ultrasound with active GPS|CVC insertion with ultrasound with active GPS function and appropriate needles
16090676|NCT02231528|Device|Use of ultrasound with inactive GPS|CVC insertion with ultrasound with inactive GPS function and conventional needles
16090677|NCT02231515|Device|Selective laser trabeculoplasty (SLT)|Selective laser trabeculoplasty
16090678|NCT02231515|Device|Pattern laser trabeculoplasty (PLT)|Pattern laser trabeculoplasty (PLT)
16090681|NCT02231489|Drug|JNJ-42756493 Tablet|Participants will receive 10 mg of JNJ-42756493 tablet as single oral dose on Day 1 of each treatment period.
16090682|NCT02231489|Drug|JNJ-42756493 Capsule|Participants will receive 10 mg of JNJ-42756493 capsule as single oral dose on Day 1 of each treatment period.
16090683|NCT02231489|Drug|JNJ-61818549|Participants will JNJ-61818549, 100 microgram (mcg) intravenous infusion over 5 minutes, after 2 hours of administration of JNJ-42756493 tablet/capsule on Day 1 Treatment Period 1.
16090684|NCT02231463|Other|neutral positioning, PEEP 0 cm H2O|neutral positioning, PEEP 0 cm H2O
16090685|NCT02231463|Other|neutral positioning, PEEP 5cm H2O|neutral positioning, PEEP 5cm H2O
16090686|NCT02231463|Other|neutral positioning, PEEP 10cm H2O|neutral positioning, PEEP 10cm H2O
16090687|NCT02231463|Other|Trendelenburg positioning -20°, PEEP 0 cmH2O|Trendelenburg positioning -20°, PEEP 0 cmH2O
16090688|NCT02231463|Other|Trendelenburg positioning -20°, PEEP 5 cmH2O|Trendelenburg positioning -20°, PEEP 5 cmH2O
16090689|NCT02231463|Other|Trendelenburg positioning -20°, PEEP 10 cmH2O|Trendelenburg positioning -20°, PEEP 10 cmH2O
16090690|NCT02231450|Drug|Lu AE58054 encapsulated film-coated tablets|
16090691|NCT02231437|Drug|Berodual®|
16090692|NCT02231424|Drug|Drug: Berodual®|
16090693|NCT02231411|Procedure|V-DCC|Ventilation with CPAP 5 cm H2O between inflations and Delayed clamping of the umbilical cord for 60 seconds
16090694|NCT02231411|Procedure|Delayed cord clamping|Delayed clamping of the umbilical cord for 60 seconds
16090695|NCT02231411|Procedure|Dry and and if apneic initially can stimulate by gently rubbing the back for approximately 30 seconds with warm sterile towels|
16090696|NCT02231385|Drug|Acetic Acid|"Subjects in Group A (study group) will undergo a standard colonoscopy. Once the right colon has been fully examined, acetic acid 2% will be sprayed and the right colon re-examined from cecum to hepatic flexure with within a frame-time of two minutes.
~Subjects in Group B (control group) will undergo a second examination of the right colon without acid acetic and within the same frame-time."
16090697|NCT02231372|Drug|Berodual® Respimat® solution for inhalation|
16090698|NCT02231359|Drug|Berodual® Respimat® solution for inhalation|
16090699|NCT02231346|Drug|Berodual® Respimat® - inhaler|
16090700|NCT02231333|Drug|S-adenosylmethionine (SAMe)|
16090701|NCT02231333|Drug|pentoxiphylline (PTX)|
16090702|NCT02231320|Drug|Berodual® Respimat® - inhaler|
16090703|NCT02231307|Drug|SUBLIVAC FIX Birch|
16090704|NCT02231294|Drug|Sifrol®|
16090705|NCT02231281|Drug|cART(TDF/AZT+3TC+LPV/r)|Standard antiretroviral therapy for HIV infection
16090706|NCT02231281|Procedure|CTL infusion|cART(TDF/AZT+3TC+LPV/r) plus autologous HIV-1 specific cytotoxic T lymphocyte (CTL) infusion
16090707|NCT02231268|Drug|Gladem|
16090708|NCT02231255|Drug|Sifrol®|
16090709|NCT02231242|Biological|Autologous Stem Cell Transplantation|"Patients will be stimulated with Granulocyte Colony Stimulating Factor (G-CSF) 3 consecutive days. Bone marrow will be harvested under sedation and, after being processed in the laboratory, the buffy coat (TNC) of 10 mL will be infused intrathecally.
~Intrathecal Autologous Bone Marrow TNC"
16090710|NCT02231229|Other|PCR-based strategy|Treatment based on the results of detection of resistance to isoniazid and rifampicin using PCR (GenoType ® Mycobacterium Tuberculosis Drug Resistance (MTBDR)plus 2.0) in a smear positive patient with pulmonary tuberculosis: initiation of a 3 drug combination (isoniazid (H / INH); rifampicin (R /RIF); pyrazinamide (Z / PZA)) if no resistance is detected and treatment based on suspected resistance in case of INH and/or RIF resistant strain.
16090711|NCT02231229|Drug|conventional therapy|Initiation of a standard 4 drug combination (isoniazid (H / INH); rifampicin (R /RIF); pyrazinamide (Z / PZA); ethambutol (EMB or E)) until the results of DST are available.
16090712|NCT02231216|Procedure|Rhinoseptoplasty|Rhinoseptoplasty without turbinectomy procedure
16090713|NCT02231216|Procedure|Partial turbinectomy|After medial dislocation of the inferior turbinate, proceed partial resection of the inferior turbinate in all its inferior extension in range. Possible bleeding is cauterized.
16090714|NCT02231216|Procedure|Endoscopic partial turbinectomy|Endoscopy to medial dislocation of the inferior turbinate with instrument
16090715|NCT02231203|Drug|Omegaven|2 infusions, 2 ml/kg, one the night before operation and one the day after operation
16090716|NCT02231203|Drug|Placebo|2 infusions, 2 ml/kg, one the night before operation and one the day after operation
16090717|NCT02231190|Drug|GSK1278863|GSK1278863 will be supplied as oral tablet of strength 100mg, 5mg(5mg if a low dose is elected for subjects enrolled after interim analysis) to be administered with 240 mL of water after end of eccentric exercise
16090718|NCT02231190|Drug|Placebo|GSK1278863 matching placebo will be supplied as oral tablets for administration with 240 mL of water after end of eccentric exercise
16090719|NCT02231177|Drug|BI 1744 CL|
16090720|NCT02231177|Drug|BI 1744 CL/Tiotropium FDC|
16090721|NCT02231177|Drug|Tiotropium|
16090722|NCT02231164|Drug|docetaxel|intravenous chemotherapy drug
16090723|NCT02231164|Drug|docetaxel|intravenous chemotherapy drug
16090724|NCT02231164|Drug|placebo|oral placebo
16090725|NCT02231164|Drug|nintedanib|oral experimental therapy
16090726|NCT02231151|Behavioral|The type of CPR error(s) shown to the individual|Participants will be randomly assigned 12 videos to watch and rate the CPR quality of each. Investigators will be blind to the identity of the participants.
16090727|NCT02231138|Drug|Abelmoschus manihot (AM)|Abelmoschus manihot (AM): Huanghui capsule (Jiangsu Suzhong Pharmaceutical Group Co., Ltd.), 0.5 g × 30 capsules/box. A huangkui capsule is a single plant drug extract of Flos Abelmoschus manihot.
16090728|NCT02231125|Drug|Losartan|Losartan potassium tablet 100mg/time, once /day plus Huangkui Capsule dummy 2.5g/time, thrice /day, all drug and dummy are taken orally every day for 48 weeks during the whole study process.
16090729|NCT02231125|Drug|Abelmoschus manihot|Huangkui Capsule 2.5g/time, thrice /day plus Losartan potassium tablet dummy 100mg/time, once /day, all drug and dummy are taken orally every day for 48 weeks during the whole study process.
16090730|NCT02231112|Radiation|Whole breast RT on prone position|
16090731|NCT02231099|Procedure|Prolift + M|prolapse surgery with mesh
16090732|NCT02231099|Procedure|conventional vaginal prolapse surgery|conventional vaginal prolapse surgery;anterior colporrhaphy, posterior colporrhaphy
16090733|NCT02231086|Procedure|Adjuvant HIPEC (open/laparoscopic)|Adjuvant HIPEC procedure: access to the abdominal cavity by laparoscopy or laparotomy under general anaesthesia, adhesiolysis if necessary, complete staging of the intra-abdominal cavity, positioning of in- and outflow catheters, perfusion with a minimum of 2l isotonic dialysis fluid at a flow rate of 1-2l/min and an inflow temperature of 42-43˚C. Before the beginning of HIPEC, 5-fluorouracil 400 mg/m2 and leucovorin 20 mg/m2 will be administered intravenously to potentiate oxaliplatin activity. Oxaliplatin (460 mg/m2) is added to the perfusate after attaining at least 42 degrees inflow temperature with a total of 30 minutes perfusion time.
16090734|NCT02231086|Drug|Standard adjuvant systemic chemotherapy|Colon cancer patients with a high risk of developing PC, but do not have (yet) proven macroscopic peritoneal metastasis, are standardly treated with adjuvant systemic chemotherapy. Standard adjuvant systemic chemotherapy consists in the Netherlands of a capecitabine and oxaliplatin (CAPOX) or 5-FU and oxaliplatin (FOLFOX) for a total of 6 months.
16090735|NCT02231086|Procedure|Diagnostic laparoscopy|Presence or absence of peritoneal recurrence will be evaluated by laparoscopy in case of negative routine examination (CEA and CT thorax/abdomen) at 18 months postoperatively in both study arms.
16090736|NCT02231073|Behavioral|Exercise and Education for Parkinson's Disease|Exercise and Education for Parkinson's Disease for 6 week cross-over intervention.
16090737|NCT02231047|Dietary Supplement|64N Nutraceutical|40 mg/kg/day of powdered 64N mixed in 12 ounces of a warm drink for 1 week (7 days)
16090738|NCT02231047|Other|No 64N Nutraceutical|12 ounce warm drink daily for 1 week (7 days)
16090739|NCT02231021|Drug|alogliptin|alogliptin 25 mg add-on background medication metformin
16090740|NCT02231021|Drug|Pioglitazone|pioglitazone 30 mg add-on background medication metformin
16090741|NCT02231021|Drug|alogliptin + pioglitazone|alogliptin 25 mg and pioglitazone 30 mg add-on background medication metformin
16090742|NCT02231008|Drug|tasimelteon|
16090743|NCT02230995|Drug|metformin|single dose of metformin given as tablets
16090744|NCT02230995|Drug|empagliflozin/metformin|Single dose empagliflozin/metformin given as fixed-dose combination tablet
16090745|NCT02230995|Drug|empagliflozin|single dose of empagliflozin given as tablet
16090746|NCT02230982|Drug|nintedanib|soft gelatin capsule
16090747|NCT02230969|Drug|peginterferon beta-1a|Administered as specified in the treatment arm
16090748|NCT02230956|Biological|onabotulinumtoxinA|onabotulinumtoxinA (botulinum toxin Type A) injection into the intra-articular space of the study knee.
16090749|NCT02230956|Drug|Normal Saline|Normal Saline (placebo) injection into the intra-articular space of the study knee.
16090750|NCT02230930|Drug|Apomorphine 0.25% (2.5mg/ml)|Apomorphine 0.5% (5mg/ml) will be diluted to 0.25% (2.5mg/ml) by the addition of the same volume physiological saline (NaCl 0.9%).
16090751|NCT02230930|Device|Massage with a spiky ball|Each patient will massage skin reactions with a spiky ball 3 times a day for 2 minutes.
16090752|NCT02230930|Drug|Hydrocortisone cream 1%|Hydrocortisone cream 1% (1mg/g) will be administered on each nodule one time a day
16090753|NCT02230930|Drug|Subcutaneous hydrocortisone 10mg|Subcutaneous hydrocortisone 10mg will be administered previous to apomorphine infusion making use of the apomorphine infusion system
16090754|NCT02230917|Drug|Sotatercept|
16090755|NCT02230917|Drug|Placebo|
16090756|NCT02230904|Drug|Rotigotine (Test product PR 2.3.1)|"Pharmaceutical form: Transdermal patch
~Concentration: 8 mg/24 hours
~Route of administration: Transdermal"
16090757|NCT02230904|Drug|Rotigotine (Reference product PR 2.1.1)|"Pharmaceutical form: Transdermal patch
~Concentration: 8 mg/24 hours
~Route of administration: Transdermal"
16090758|NCT02230891|Drug|Carvedilol|Carvedilol is a non selective beta blocker
16090759|NCT02230891|Drug|Spironolactone|Spironolactone is an aldosterone antagonist and can lower blood pressure/ is used in heart failure
16090760|NCT02230878|Drug|JNJ-42847922 5 mg|Participants will receive 5 mg of JNJ-42847922, from Day 1 up to Day 10.
16090761|NCT02230878|Drug|JNJ-42847922 10 mg|Participants will receive 10 mg of JNJ-42847922, from Day 1 up to Day 10.
16090762|NCT02230878|Drug|JNJ-42847922 20 mg|Participants will receive 20 mg of JNJ-42847922, from Day 1 up to Day 10.
16090763|NCT02230878|Drug|JNJ-42847922 40 mg|Participants will receive 40 mg of JNJ-42847922, from Day 1 up to Day 10 .
16090764|NCT02230878|Drug|Placebo|Participants will receive matching placebo from Day 1 up to Day 10.
16090765|NCT02230839|Behavioral|Exercise|Participants will complete a progressive 6-month exercise training program, 4-5 days per week, 45 min per session (180 min per week), consisting mostly of walking (both outside and on an indoor treadmill) but with the option to include stationary cycling, elliptical and rowing machines, similar to what we have utilized previously to elicit significant improvements in insulin sensitivity in both middle-age and older adults (52-55). Beginning at week 8, these subjects will also perform 2 non-consecutive resistance exercise sessions per week, 30 min per session, focused on major muscle groups using resistance machines (total days of exercise will still be 4 to 5).
16090766|NCT02230839|Behavioral|Energy Restriction-Induced Weight Loss|The goal of the weight loss intervention will be to produce a weight loss of 10% body weight. A reduction of 500-1000 kcal/day - based on baseline weight -and low fat (<30% of calories from fat) diet will be used as part of the weight loss intervention.
16090767|NCT02230800|Drug|Tocovid SupraBio plus pentoxifylline|
16090768|NCT02230800|Drug|Matching placebos|
16090769|NCT02230787|Device|Recession coverage without Emdogain|In the control group subjects the recession coverage surgery will be performed without Emdogain.
16090770|NCT02230787|Device|Recession coverage with Emdogain|In the test group subjects the recession coverage surgery will be performed with Emdogain.
16090771|NCT02230761|Drug|XOPH5 Ointment|
16090772|NCT02230761|Drug|Placebo|
16090773|NCT02230735|Drug|Bipivacaine 0.5% with epinephrine|Total of 14 ml of bupivacaine hydrochloride 0.5% with epinephrine 1:200,000, 7ml in right uterosacral ligament, 7ml in left uterosacral ligament
16090774|NCT02230735|Drug|Normal Saline|(placebo for bupivacaine)
16090775|NCT02230722|Behavioral|Motivational Interviewing|
16090776|NCT02230722|Behavioral|Attention Control|
16090777|NCT02230709|Other|Dry Needling|Needling with acupuncture needle in a myofascial trigger point.
16090778|NCT02230709|Other|"TENS and dry needling"|Application of TENS current after dry needling technique
16090782|NCT02230683|Drug|IDN-6556|25 mg BID
16090783|NCT02230670|Drug|IDN-6556|25 mg BID
16090784|NCT02230670|Drug|Placebo|
16090785|NCT02230657|Procedure|Same day discharge|
16090786|NCT02230657|Procedure|Next day discharge|
16090787|NCT02230644|Other|Enhanced clinical environment|Surgical booths containing artwork and calming background music.
16090788|NCT02230644|Other|Other distraction|Such as newspaper, magazine or the news on television
16090789|NCT02230631|Other|No treatment given|Two different questionnaires will be applied to patients during a regular clinical visit.
16090790|NCT02230618|Drug|insulin degludec/insulin aspart|Ryzodeg™ will be prescribed by the physician under normal clinical practice conditions and will be obtained/purchased from the chemist based on physician prescription. No treatment given.
16090791|NCT02230605|Other|Mini-Mental State Examination|To be completed at the Screening Visit and Post-Operative Day 7 Visit (or Discharge)
16090792|NCT02230605|Other|Self-Administered Gerocognitive Examination|To be completed at the Screening Visit and Post-Operative Day 7 Visit (or Discharge)
16090793|NCT02230605|Other|Geriatric Depression Scale|To be completed at the Screening Visit and at POD 90
16090794|NCT02230605|Other|Charlson Comorbidity Index|To be completed at the Screening Visit and at POD 90
16090795|NCT02230605|Other|Short Form 36 Health Survey|To be completed at the Screening Visit
16090796|NCT02230605|Other|Confusion Assessment Method|To be completed at the Day 0 (Pre-Operative) Visit, Day 0 (Post-Operative) Visit, and Day 1-7 Visits at 7:30AM ± 1.5 hrs and 6:30PM ± 1.5 hrs. (or until hospital discharge)
16090797|NCT02230605|Other|Memorial Delirium Assessment Scale|To be completed at the Day 0 (Pre-Operative) Visit, Day 0 (Post-Operative) Visit, and Day 1-7 Visits at 7:30AM ± 1.5 hrs and 6:30PM ± 1.5 hrs. (or until hospital discharge)
16090798|NCT02230605|Other|Postoperative Quality of Recovery Scale|To be completed at Day 0 (Post-Operative) Visit, and Day 1-7 Visits at 6:30PM ± 1.5 hrs (or until hospital discharge). Will be completed POD 7 over the phone if patient already discharged. Will be completed on POD 30 and POD 90.
16090799|NCT02230579|Drug|MMV390048 5mg|"Supplied as powder in bottle formulation for reconstitution pre-dose"
16090800|NCT02230579|Drug|MMV390048 20mg|"Supplied as powder in bottle formulation for reconstitution pre-dose."
16090801|NCT02230579|Drug|MMV390048 40mg|"Supplied as powder in bottle formulation for reconstitution pre-dose"
16090802|NCT02230579|Drug|MMV390048 80mg|"Supplied as powder in bottle formulation for reconstitution pre-dose"
16090803|NCT02230579|Drug|MMV390048 120mg|"Supplied as powder in bottle formulation for reconstitution pre-dose"
16090804|NCT02230579|Drug|Placebo to match MMV390048|"Supplied as powder in bottle formulation for reconstitution pre-dose"
16090805|NCT02230566|Drug|UX003|UX003 is a sterile concentrate formulation of rhGUS for intravenous infusion
16090806|NCT02230566|Other|Placebo|Placebo consisting of the UX003 formulation buffer (without rhGUS)
16090807|NCT02230553|Drug|Lapatinib|
16090808|NCT02230553|Drug|trametinib|
16090809|NCT02230540|Device|SelfCath (comparator)|Commercially available CE-marked catheter for urinary drainage.
16090810|NCT02230540|Device|Product A SelfCath and urine bag, Conveen Security+|SelfCath and urine bag, Conveen Security+ (both commercially available CE-marked devices).
16090811|NCT02230540|Device|Product B SelfCath and urine bag, Conveen Contour|SelfCath and urine bag, Conveen Contour (both commercially available CE-marked devices).
16090812|NCT02230527|Drug|Ticagrelor|90mg twice a day by mouth
16090813|NCT02230527|Drug|Clopidogrel|75mg once a day by mouth
16090814|NCT02230514|Drug|XCEL-MT-OSTEO-ALPHA|"ex-vivo expanded autologous mesenchymal stromal cells fixed in allogenic bone tissue in association with open surgery"
16090815|NCT02230514|Other|autologous iliac crest|Autologous iliac crest in association with surgery
16090816|NCT02230514|Procedure|Surgery|Standard surgery for non-union fractures
16090817|NCT02230501|Dietary Supplement|stringent diet regimen|
16090818|NCT02230501|Dietary Supplement|moderate diet regimen|
16090819|NCT02230488|Other|Intensive Diabetes Case Management|"A diabetes team , led by an endocrinologist and CDE, will manage the patients diabetes while in the hospital and will assist with the patient's discharge Diabetes endocrine consult team will manage the patient's diabetes daily while in the hospital Discharge diabetes medication reconciliation per research team Research team will provide 30 day supply of diabetes medication/supplies at discharge Research Team will provide 30 day supply of glucose test strips at discharge Discharge telecommunication from endocrinologist to primary care provider Patient-centered discharge diabetes education per research CDE Post-discharge 48-72 hours continuity check per phone by a diabetes research team member/CDE
~--------------------------------------------------------------------------------"
16090820|NCT02230462|Other|Viewing of cancer excision defect|Patients will be invited to view their cancer excision defect, with the aid of a mirror, prior to its reconstruction.
16090821|NCT02230436|Other|Early drain removal|Removing drain(s) on postoperative day 3
16090822|NCT02230436|Other|Late drain removal|Removing drain(s) on postoperative day 4 or later
16090823|NCT02230423|Procedure|Nasal surgery|
16090825|NCT02230397|Other|plantaricin a (active product)|Product application: 8 weeks (one on the right and one on the left face side randomly) twice a day, in the morning and in the evening, with a mild massage
16090826|NCT02230397|Other|placebo product|Product application: 8 weeks (one on the right and one on the left face side randomly) twice a day, in the morning and in the evening, with a mild massage
16090827|NCT02230384|Drug|Active JNJ Drug|200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week
16090828|NCT02230384|Drug|Placebo Pill|Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week
16090867|NCT02230098|Other|Remote Ischemic Conditioning|
16090829|NCT02230371|Drug|Granisetron|If the patient does not have any pain after the first or second injection of granisetron (Kytril®; 1 mg/mL, Roche, Stockholm, Sweden), there will be no more injections but the patient will still come for the follow ups.
16090830|NCT02230371|Drug|Control (placebo)|If the patient does not have any pain after the first or second injection of granisetron (isotonic saline (NaCl); 0.9 mg/mL, Fresenius Kabi, Uppsala, Sweden), there will be no more injections but the patient will still come for the follow ups.
16090831|NCT02230358|Procedure|Regional anesthesia|Regional anesthesia
16090832|NCT02230358|Procedure|General anesthesia|General anesthesia
16090833|NCT02230358|Device|Transcranial Doppler ultrasonography|6x for 4 hours
16090834|NCT02230358|Procedure|blood gas analysis|6 x 3 ml blood withdrawal (18 ml) within 4 hours
16090835|NCT02230358|Procedure|invasive arterial blood pressure measurement|before operation, 8 hours, as done in clinical routine
16090836|NCT02230358|Procedure|arterial blood gas measurement|perioperative, 4-6 times within 8 hours, as done in clinical routine
16090837|NCT02230358|Behavioral|Neurological Control|perioperative, 2-3 days, as done in clinical routine
16090838|NCT02230358|Behavioral|NIRS monitoring|perioperative, for 5 hours, as done in clinical routine
16090839|NCT02230358|Device|oxygen supply (not invasive 'Vigileo')|perioperative for 5 hours, as done in clinical routine
16090840|NCT02230345|Dietary Supplement|Probiotic yogurt|Probiotic yogurt (fermented milk with Lactobacillus delbrueckii subsp. bulgaricus and Streptococcus thermophilus- YoFlex FD-DVS YC-X11 Fr, with the addition of Lactobacillus rhamnosus GG (LGG)- Culture Collection, University of Göteborg, Sweden CCUG 34291).
16090841|NCT02230345|Dietary Supplement|Acidified milk|Milk will consist in an isocaloric supplement (compared to probiotic yogurt) of unfermented milk
16090842|NCT02230332|Drug|Alendronate|
16090843|NCT02230332|Drug|Placebo|
16090844|NCT02230319|Other|Cryotherapy|
16090845|NCT02230319|Drug|Paclitaxel|
16090846|NCT02230306|Drug|Cobimetinib|60mg once a day; will be taken on days 1-21 of each 28 day treatment cycle; will be taken in combination with Vemurafenib;
16090847|NCT02230306|Drug|Vemurafenib|960mg twice a day; 28 day treatment cycle; will be taken in combination with Cobimetinib;
16090848|NCT02230293|Other|Multidisciplinary assistance|Multidisciplinary group assistance was effected every two months by all professionals (physician, nurse, dietitian, physiotherapist and psychologist) and consisted in orientations and mechanisms to medication and non-pharmacological adherence (lifestyle changes).
16090849|NCT02230293|Other|Conventional treatment and follow up|Assistance was effected by physician and nurse and consisted about adapting to the drug
16090850|NCT02230280|Other|Strengthening Community-Based Stroke Care: A Pilot Study of a Community Navigation and Rehabilitation Intervention that Includes a Mobile Health Solution|Participants will be offered regular in-home visits over the 6-month study period in addition to usual outpatient rehabilitation services. The health care providers will have access to a mobile health application (MYST) to share real-time information and access community resources and best practice guidelines.
16090851|NCT02230267|Other|High intensity exercise and balance training|
16090852|NCT02230267|Other|Usual care arm exercise|
16090853|NCT02230254|Device|Percutaneous coronary intervention PROMUS PREMIER|PROMUS PREMIER
16090854|NCT02230228|Drug|ALK-001 (No generic name)|Daily, oral administration of ALK-001 capsules.
16090855|NCT02230215|Device|Total Knee Arthroplasty with use of Visionaire Patient-Specific Instrumentation|The manufacturing of a patient-specific instrument to be used by the orthopaedic surgeon during the knee replacement surgery.
16090856|NCT02230202|Other|Flow-mediated dilation|Flow-mediated dilation used to measure vascular function. The test is minimally invasive, with only a slight discomfort due to the inflation of the arm cuff.
16090857|NCT02230202|Other|single blood draw|single blood draw of approximately 45 mL.
16090858|NCT02230189|Biological|Segmental airway allergen challenge|
16090859|NCT02230176|Drug|Sunitinib|
16090860|NCT02230176|Drug|177Lu-DOTA0-Tyr3-Octreotate|
16090861|NCT02230163|Biological|anti-CHIKV hyperimmune immunoglobulins|Anti-CHIKV immunoglobulins (CHIKVIg) were purified after the Tégéline manufacturing process from a pool of 583 plasma samples from donors in the convalescent phase of CHIKV infections. Anti-CHIKV hyper immune intravenous immunoglobulin (50 mg/ml) is prepared as a powder to be reconstituted. The therapeutic regimen will consist of 2 doses of 0.5 g/kg 12 hours apart.
16090862|NCT02230150|Behavioral|Adhesion-HF|The hypothesis that was investigated is whether the nursing consultation improves therapeutic strategies for membership, adherence to self-care, improved levels of NT-proBNP improves performance in 6-minute walk test, monitoring of biomarkers of laboratory tests (sodium , potassium, urea, creatinine and NT-proBNP) frequent occurrence of readmissions and mortality in patients with heart failure after 1 month.
16090863|NCT02230137|Behavioral|Text message arm|Text message sent before each injection of insulin
16090864|NCT02230124|Device|MRE|
16090865|NCT02230111|Behavioral|Energy restriction plus CDR|Subjects will receive a reduced-calorie low energy density diet which will provide 85% of their energy needs for a period of 4 weeks. In the condition in which an increase in CDR will be induced, women will be told at the beginning of the study and will be reminded throughout the 4-week duration of the experimental condition that they are on a low-calorie diet and that it is important not to eat more than what is provided and that they should strictly avoid non-study food if they want to lose weight and improve their blood pressure. Subjects will receive feedback about their weight trajectory. After the 4-week controlled intervention women will then receive further information and advices to pursue their weight loss on their own and keeping on with strategies relying on an increase in CDR.
16090866|NCT02230111|Behavioral|Energy restriction without CDR|Subjects will receive the same low-calorie diet (85% of their energy needs) for 4 weeks but will not be told that they are on an energy-deficit diet. They will be told at the beginning of the study that the food provided cover all their nutrient needs and that they should eat until satiation. There will be no emphasis on body weight and subjects will be reminded that the aim of the intervention is to document the effects of a diet rich in vegetables and fruits on blood pressure. After the 4-week controlled diet, participants will be taught about the impact of a low energy density diet on satiation and satiety. They will receive further information and advices (with non-restrictive messages) to incorporate more vegetables and fruits in their usual diet.
16090868|NCT02230085|Other|Administration of the questionnaire and monitoring of CPAP adherence|
16090869|NCT02230072|Device|fetoscopy|The fetoscopic arm is described above. All patients will have a laparotomy, exteriorization of the uterus, and a fetoscopic repair of the fetal open neural tube defect.
16090870|NCT02230059|Other|No Intervention|Medical charts of participants with metastatic castration-resistant prostate cancer will be observed.
16090871|NCT02230046|Drug|Abiraterone acetate (Treatment A)|Participants will receive a single oral 1000 mg dose of abiraterone acetate as Treatment A (current commercial formulation, 4*250 mg uncoated tablets) under fasted conditions on Day 1 of period as specified in the protocol.
16090872|NCT02230046|Drug|Abiraterone acetate (Treatment B)|Participants will receive a single oral 1000 mg dose of abiraterone acetate as Treatment B (current commercial formulation, 4*250 mg coated tablets) under fasted conditions on Day 1 of period as specified in the protocol.
16090873|NCT02230046|Drug|Abiraterone acetate (Treatment B)|Participants will receive a single oral 1000 mg dose of abiraterone acetate as Treatment C (new composition, 2*500 mg coated tablets) under fasted conditions on Day 1 of period as specified in the protocol.
16090874|NCT02230033|Drug|JNJ-56021927|Single oral dose of JNJ-56021927 240 milligram (mg) capsule will be administered on Day 1 or Day 4 in any of the treatment.
16090875|NCT02230033|Drug|Itraconazole|Itraconazole 200 mg (2 capsules of 100 mg) will be administered once daily orally from Day 1 until Day 32.
16090876|NCT02230033|Drug|Gemfibrozil|Gemfibrozil 600 mg oral tablet will be administered twice daily from Day 1 until Day 32.
16090877|NCT02230020|Device|Nasal High Flow|
16090878|NCT02230007|Drug|MEOPA|3 sessions of reeducation using MEOPA
16090879|NCT02229994|Other|Cross sectional psychometric evaluation of a self-administered dyspnea questionnaire.|"Evaluation will be performed on a group of 200 patients deriving from 4 samples.
~From these 200 patients, a sub-sample will be evaluated at 7 days (DYSLIM questionnaire only) for reproducibility (n = 50 patients: 10 patients with diffuse interstitial lung disease, 10 patients with cystic fibrosis, 10 patients with arterial pulmonary hypertension, 20 patients with COPD).
~From these 200 patients, a sub-sample (COPD, n = 60) will be recruited among patients undergoing pulmonary rehabilitation at the beginning of the 6 months separating follow up visit and the initial assessment."
16090880|NCT02229981|Drug|ABC294640|
16090881|NCT02229968|Drug|Amicar (ε-aminocaproic acid)|
16090882|NCT02229968|Drug|normal saline|
16090883|NCT02229955|Drug|Cyclosporine ophthalmic solution|1 drop twice/day for 12 weeks to both eyes
16090884|NCT02229942|Drug|Rituximab|"Induction with two infusions two weeks apart, rituximab 500 mg/m2 (max 1000 mg).
~Maintenance with rituximab infusions (500 mg fixed dose) at 3, 6, 9 and 12 months."
16090885|NCT02229942|Drug|Placebo|Saline (NaCl 0,9%) added human albumin (Flexbumin) 0,4 mg/ml, two infusions two weeks apart. Maintenance infusions after 3,6, 9 and 12 months.
16090886|NCT02229929|Drug|Part A: Placebo|Part A: Single i.v. dose of Placebo administered after each dialysis session over a 1 week treatment period (3 times per week)
16090887|NCT02229929|Drug|Part A: CR845 0.5 mcg/kg|Part A: Single i.v. dose of CR845 administered after each dialysis session over a 1 week treatment period (3 times per week)
16090888|NCT02229929|Drug|Part A: CR845 1.0 mcg/kg|Part A: Single i.v. dose of CR845 administered after each dialysis session over a 1 week treatment period (3 times per week)
16090889|NCT02229929|Drug|Part A: CR845 2.5 mcg/kg|Part A: Single i.v. dose of CR845 administered after each dialysis session over a 1 week treatment period (3 times per week)
16090890|NCT02229929|Drug|Part B: Placebo|Part B: Single i.v. dose of Placebo administered after each dialysis session over a 2 week treatment period (3 times per week)
16090891|NCT02229929|Drug|Part B: CR845 1.0 mcg/kg|Part B: Single i.v. dose of CR845 administered after each dialysis session over a 2 week treatment period (3 times per week)
16090892|NCT02229903|Device|Active DTMS Treatment|H-coil Deep TMS 29 TMS treatments over 6 weeks.
16090893|NCT02229903|Device|Sham Treatment|29 treatments over 6 weeks.
16090894|NCT02229890|Drug|alteplase|
16090895|NCT02229877|Drug|Omeprazole|40 mg oral capsules administered twice daily for 8.5 days
16090896|NCT02229877|Drug|Gefapixant|Gefapixant oral tablet (25 mg administered as a divided 50 mg tablet) administered twice daily for 2 days
16090897|NCT02229877|Drug|Gefapixant|Gefapixant oral tablet (50 mg tablet) administered twice daily for 8 days
16090898|NCT02229877|Drug|Gefapixant|Gefapixant oral tablet (150 mg administered as three 50 mg tablets) administered twice daily for 8 days
16090899|NCT02229864|Device|Coronary artery stenting: Absorb BVS|"Scaffold diameters: 2.5, 3.0 and 3.5 mm
~Scaffold lengths: 8, 12, 18, and 28 mm"
16090900|NCT02229851|Drug|somapacitan|Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration. Extension of 44 weeks' treatment following 8 weeks of titration.
16090901|NCT02229851|Drug|somatropin|Administered subcutaneously (s.c., under the skin) once daily for 26 weeks following 8 weeks of titration. Re-randomisation to extension of 44 weeks' treatment following 8 weeks of titration.
16090902|NCT02229851|Drug|placebo|Administered subcutaneously (s.c., under the skin) once weekly for 26 weeks following 8 weeks of titration.
16090903|NCT02229838|Drug|BIBB 1464 MS tablet|
16090904|NCT02229838|Drug|BIBB 1464 MS solution|
16090905|NCT02229838|Drug|BIBB 1464 MS placebo|
16090906|NCT02229838|Other|Standard dinner|
16090907|NCT02229825|Drug|Duloxetine high|
16090908|NCT02229825|Drug|Duloxetine low|
16090909|NCT02229812|Drug|alteplase|
16090910|NCT02229799|Drug|Actilyse|
16090911|NCT02229786|Drug|Buscopan® plus|
16090912|NCT02229786|Drug|Buscopan®|
16090913|NCT02229786|Drug|Paracetamol|
16090914|NCT02229786|Drug|Placebo|
16090915|NCT02229773|Drug|BIBB 1464 MS low dose|
16090916|NCT02229773|Drug|Placebo|
16090917|NCT02229773|Drug|Pravastatin|
16090918|NCT02229773|Drug|BIBB 1464 MS medium dose|
16090919|NCT02229773|Drug|BIBB 1464 MS high dose|
16090920|NCT02229760|Drug|Tipranavir capsules|
16090921|NCT02229760|Drug|Ritonavir capsules|
16090922|NCT02229747|Drug|Meloxicam|
16090923|NCT02229747|Drug|Diclofenac|
16090924|NCT02229747|Drug|Nimesulide|
16090925|NCT02229734|Radiation|Radiation|Radiation: Radiotherapy 7 gray (Gy) per week over 5 weeks (35Gy)
16090926|NCT02229734|Drug|Androgen Suppression|Leuprolide 45mg every 6 months for a total of 18 months
16090927|NCT02229721|Drug|Syntocinon Nasalspray|"Over 8 weeks, intranasal oxytocin (32 IE) or placebo will be self-administered by women prior to sexual intercourse. Following a washout period of 2 weeks, a cross-over will take place and patients switched to the alternate group for another 8 weeks.
~The recommended dose is four puffs per nostril, containing 32 IU of synthetic oxytocin, administered up to 50 minutes prior to sexual activity. The maximal dose should not exceed four puffs per nostril per day; the minimum dose was twice weekly."
16090928|NCT02229721|Drug|Placebo Nasalspray|"Over 8 weeks, intranasal oxytocin (32 IE) or placebo will be self-administered by women prior to sexual intercourse. Following a washout period of 2 weeks, a cross-over will take place and patients switched to the alternate group for another 8 weeks.
~The recommended dose is four puffs per nostril, administered up to 50 minutes prior to sexual activity. The maximal dose should not exceed four puffs per nostril per day; the minimum dose was twice weekly."
16090929|NCT02229708|Behavioral|Healthy Lifestyle Group|
16090930|NCT02229682|Radiation|Mild-dose IMRT|IMRT is delivered using 6-8 MeV linear accelerator using intensity-modulated radiation treatment planning. The radiation dose is 46.2 grays (Gy) in 22 fractions.
16090931|NCT02229669|Procedure|Horizontal incisions|Performed by using horizontal interdental incisions. An initial horizontal incision was made slightly coronal to the CEJ from the distal to the mesial papilla of the teeth with the recessions. A second incision, 1 to 2 mm apart and parallel to the first incision, was made apically. A sulcular incision was made to link the second incisions and the blade was inserted (2 to 3 mm) extending beyond the mucogingival junction (MGJ), to create a uniform split-thickness flap. The tissue between the two incisions was partially removed to obtain a uniform receptor site that permitted primary closure. Approximation sutures to place the edge of the flap at the base of the remaining papilla were performed. Passive closure of the wound margins without tension was achieved with interrupted coaptation.
16090932|NCT02229669|Procedure|Oblique incisions|Coronally advanced flap was performed by using oblique incisions in interdental areas, according to the technique proposed by Zucchelli & De Sanctis (2000). Oblique submarginal interdental incisions were performed and continued with the intrasulcular incisions at the recession defects, resulting in a envelop flap that was raised with a split-full-split approach in the coronal-apical direction. During coronal advancement, each surgical papilla was dislocated with respect to the de-epithelized anatomic papilla by the oblique incisions. Interrupted sutures were performed to stabilize single surgical papilla over the interdental connective tissue bed.
16090933|NCT02229656|Radiation|radiotherapy|Primary tumor and lymph nodes will receive 35 fractions of 2 Gy resulting in a total dose of 70 Gy. Elective fields will receive 35 fractions of 1.55 Gy resulting in a total dose of 54.25 Gy in case a SIB technique is used, or 23 fractions of 2 Gy resulting in a total dose of 46 Gy in case a sequential boost technique is used. The higher total prescribed physical dose to the elective fields in a SIB technique based RT plan compensates for the lower dose per fraction and results in an equal biological effective dose when compared with a sequential boost technique.
16090934|NCT02229656|Drug|Olaparib|The pre-defined dose levels of olaparib are 25mg QD, 25, 50, 100, 200, and 300 mg BID
16090935|NCT02229630|Radiation|Pregnant women with intra-uterine growth restricted Foetuses|Diffusion-weighted cerebral MRI before 32 weeks of gestation
16090936|NCT02229617|Drug|Subcutaneous testosterone|
16090937|NCT02229604|Other|EA|For BL33, insert the needle to the third posterior sacral foramina to a depth of 80-100mm. For ST25, EX-CA1 and RN4, the needle will be inserted vertically and quickly through the skin, and then slowly and vertically penetrate through the layer of fatty tissue, up into the muscles of the abdominal wall (until the moment of resistance is sensed on the tip of the needle and the participant feels a sting). The electric stimulator will be put on the BL33 and EX-CA1 with a continuous wave, 20 Hz, 1.0-4.0 mA.
16090938|NCT02229604|Drug|HRT, DHEA and herb|HRT, dehydroepiandrosterone (DHEA) and herb decoction could be used for this group. Time frame of treatment is not fixed. Herb decoction will be given to participants based on the principle of syndrome differentiation (a diagnosing method in Traditional Chinese Medicine).
16090939|NCT02229578|Drug|Lidocaine|Subjects in this group will receive a nonpyrogenic solution of lidocaine 2% in isotonic saline (Solution A) sprayed on the donor site of the grafted skin prior to emergence from general anesthesia. A total maximum of 7mg/kg of lidocaine solution will be available for administration. Prior to spraying of the Solution A, the donor site will be soaked with epinephrine soaked towels as per routine burn care. The site will then be covered with TheraBond dressing as per standard burn care.
16090940|NCT02229578|Drug|Placebo|Subjects in this group will receive a nonpyrogenic solution of isotonic saline (Solution B) sprayed over the donor site. Prior to spraying of the Solution B, the donor site will be soaked with epinephrine soaked towels as per routine burn care. The site will then be covered with TheraBond dressing as per standard burn care.
16090941|NCT02229565|Device|Biopsy or prostatectomy|
16090942|NCT02229552|Other|Standardized Assessments|Children were asked to attend appointments without consuming study foods 24 hours previously, as habituation measurements are sensitive to recent consumption. Children were provided access to snack prior to completing questionnaires or cognitive assessments. Habituation to food, questionnaires and cognitive assessments were re-measured at 1-year and 2-year follow up.
16090943|NCT02229539|Drug|doxepin hydrochloride oral solution|2.5 mL (25 mg) doxepin and 2.5 mL water administered orally
16090944|NCT02229539|Drug|DLA (diphenhydramine, lidocaine and antacids) rinse|5.0 mL administered orally
16090945|NCT02229539|Other|Placebo|2.5 mL placebo and 2.5 mL water administered orally
16090946|NCT02229526|Dietary Supplement|Low dose fish oil|Four 1g gelatine capsules with fish oil (Pikasol: 32 % eicosapentaenoic acid (20:5n-3), 23 % docosahexaenoic acid (22:6n-3) and 2 mg tocopherol/ml)) corresponding to 2.7 g n-3 fatty acids per day.
16090947|NCT02229526|Dietary Supplement|Low dose olive oil|Four 1 g capsules with olive oil (72 % oleic acid (18:1n-9) and 12 % linoleic acid (18:2n-6)) per day.
16090948|NCT02229526|Dietary Supplement|High dose fish oil|Nine 1g gelatine capsules with fish oil (Pikasol: 32 % eicosapentaenoic acid (20:5n-3), 23 % docosahexaenoic acid (22:6n-3) and 2 mg tocopherol/ml)) corresponding to 6.1 g n-3 fatty acids per day.
16090949|NCT02229526|Dietary Supplement|High dose olive oil|Nine 1g gelatine capsules with olive oil (72 % oleic acid (18:1n-9) and 12 % linoleic acid (18:2n-6)) per day.
16090950|NCT02229513|Procedure|Uterine Cooling|Immediately following delivery of the fetus the uterus will be externalized in the usual fashion and the body of the uterus cephalad to the hysterotomy incision will be wrapped in sterile surgical towels saturated in sterile, iced normal saline. These towels will come from a sterile cooling pot set to 30 degrees Fahrenheit. Iced saline-soaked towels will be kept in place for a minimum of 5 minutes and replaced at the discretion of the attending obstetrician until the hysterotomy is closed and the uterus is replaced into the patient's abdomen.
16090951|NCT02229500|Dietary Supplement|Inulin|
16090952|NCT02229500|Dietary Supplement|2.5 g of propionate|This system delivers approximately 2.5 g of propionate to the colon in a 10g dose.
16090953|NCT02229500|Dietary Supplement|5 g of propionate|This delivers approximately 5g of propionate to the colon per 10g dose
16090954|NCT02229487|Other|Oral glucose tolerance|
16090955|NCT02229474|Behavioral|CST Intervention|The CST intervention comprises 14 sessions lasting 1-2 hours across 7 weeks. The CST manual has been adapted for use in this setting by members of our study team. Each session has a theme. Activities include tasks aimed at engaging participants in cognitive and physical tasks designed to improve quality of life. Sessions will be led and facilitated by a study nurse or occupational therapist. The sessions will be held at a local health centre of village hall.
16090956|NCT02229461|Drug|Naproxen Sodium (Aleve, BAY117031)|Naproxen sodium 220 mg qd or bid
16090957|NCT02229461|Drug|Acetylsalicylic Acid (Aspirin, BAYE4465)|ASA 81 mg qd
16090958|NCT02229422|Drug|GA101/HDMP|"All subjects will receive GA101 - Obinutuzumab by IV infusion for up to 6 cycles (28-day cycles) as follow:
~On Cycle 1, Day 1, 100 mg GA101-obinutuzumab will be administered.
~On Cycle 1, Day 2, 900 mg of GA101-obinutuzumab will be administered.
~On Cycle 1, Days 8 and 15, 1,000 mg of GA101-obinutuzumab will be administered.
~On Cycles 2-6, Day 1, 1,000 mg of GA101-obinutuzumab will be administered.
~All subjects will receive HDMP by IV infusion for up to 4 cycles (28-day cycles) as follow:
~•On Cycle 1-4, Days 1 to 3, 1,000 mg/m2 Methylprednisolone will be administered."
16090959|NCT02229409|Behavioral|Walkadoo|Walkadoo is a MeYou Health, LLC product.
16090960|NCT02229396|Drug|Exantide with Dapagliflozin|2 mg weekly suspension injection and 10 mg Dapagliflozin
16090961|NCT02229396|Drug|Exentide|2 mg
16090962|NCT02229396|Drug|Dapagliflozin|10 mg once daily Dapagliflozin
16090963|NCT02229383|Drug|Exenatide|2 mg weekly suspension injection
16090964|NCT02229383|Drug|Exenatide matching placebo|Once weekly Placebo injection
16090965|NCT02229357|Biological|OrniFlu® inactivated vaccine|All subjects will receive a single dose of an H5 inactivated influenza vaccine after blood collection for immunology assays
16090967|NCT02229331|Other|Gait analysis|
16090968|NCT02229318|Dietary Supplement|FruitiVits|Daily administration of FruitiVits dietary supplement
16090969|NCT02229305|Behavioral|Usual Care Treatment|Usual Care therapists could use any treatment procedures they used regularly in their clinical practice.
16090970|NCT02229305|Behavioral|Modular Approach to Therapy for Children|Therapists used the Modular Approach to Therapy for Children with Anxiety, Depression, Trauma, or Conduct Problems (MATCH-ADTC; Chorpita & Weisz, 2010).
16090971|NCT02229292|Drug|Tranexamic Acid|"Active group:
~Undergoes elective bi-maxillary orthognathic surgery consisting of a (un)/segmented LeFort I osteotomy combined with a bilateral sagittal split osteotomy, under the influence of 10ml tranexamic acid (100mg/ml) administered iv. prior to the onset of the surgical procedure."
16090972|NCT02229292|Drug|Saline|"Placebo group:
~Undergoes elective bi-maxillary orthognathic surgery consisting of a (un)/segmented LeFort I osteotomy combined with a bilateral sagittal split osteotomy, under the influence of 10ml sodium chloride (9mg/ml) administered iv. prior to the onset of the surgical procedure."
16090973|NCT02229279|Device|Teleconsulting|
16090974|NCT02229266|Biological|NK cells|
16090975|NCT02229266|Drug|Cytarabine|1 cycle of consolidation chemotherapy with high-dose cytarabine
16090976|NCT02229253|Drug|degarelix|
16090977|NCT02229240|Drug|Albiglutide|Albiglutide is intended for self-administration as a SC injection. It is provided as a fixed dose of 30 mg of albiglutide or 50 mg of albiglutide in a 0.5 mL injection volume, fully disposable pen injector
16090978|NCT02229240|Drug|Matching albiglutide placebo|Matching albiglutide placebo will be provided as 0.5-mL injection, fully disposable pen injector system
16090979|NCT02229227|Drug|Albiglutide|Albiglutide is intended for self-administration as a SC injection. It is provided as a fixed dose of 30 mg of albiglutide or 50 mg of albiglutide in a 0.5 mL injection volume, fully disposable pen injector
16090980|NCT02229227|Drug|Insulin Glargine and Insulin Lispro|Insulin glargine and insulin lispro will be provided as injection pens for SC injection
16090981|NCT02229214|Drug|Qsymia|
16090982|NCT02229214|Drug|Placebo|
16090983|NCT02229201|Drug|Propofol|4-6 mg/kg/h during anaesthesia
16090984|NCT02229201|Drug|Sevoflurane|0.8 MAC
16090985|NCT02229188|Behavioral|Problem Solving Therapy|Problem solving therapy is an evidence based behavioral intervention for late life depression. It consist of 8 weekly session of talk therapy, whereby the therapist helps the patient solve problems that are thought to be causing depressive symptoms.
16090986|NCT02229188|Behavioral|Evolution|Evo is a video game that has therapeutic elements targeting the cognitive control network. Impairment in this neural network is associated with a specific subtype of late life depression that puts people at risk for poor response to SSRIs. Evo is built from a research grade training paradigm that has shown to induce improvements in this network in healthy older adults
16090987|NCT02229188|Behavioral|Words|Words is a cognitively challenging crossword/word search type of video game that will serve as the control condition for the second phase of this project
16090988|NCT02229175|Drug|bevacizumab|intravitreal injections of antibodies inhibiting vascular endothelial growth factor
16090989|NCT02229175|Device|PASCAL Endpoint Management (EpM) laser treatment|This is an algorithm that is included in the PASCAL 577 mm yellow laser system (Topcon, Santa Clara, CA). This is FDA-approved for treatment of diabetic retinopathy and diabetic macular edema.
16091032|NCT02228889|Other|Assess hernia recurrence at 1 year postoperatively|Assess hernia recurrence at 1 year postoperatively
16090990|NCT02229149|Drug|Trastuzumab|"Treatment for all patients will consist of trastuzumab, given as a loading dose of 8 mg/kg IV on Day 1 followed by 6 mg/kg IV every 3 weeks thereafter.
~Patients randomized to the chemotherapy plus trastuzumab arm (without pertuzumab) can receive trastuzumab 6 mg/kg IV every 3 weeks if they are receiving docetaxel or capecitabine on a 3-week cycle, or 4 mg/kg IV every 2 weeks if they are receiving vinorelbine, paclitaxel, or nab-paclitaxel on a 4-week cycle. The loading dose for all patients remains 8 mg/kg.
~For patients randomized to the chemotherapy plus trastuzumab plus pertuzumab arm, both trastuzumab and pertuzumab need to be administered every 3 weeks regardless of which chemotherapy agent they are receiving."
16090991|NCT02229149|Drug|Pertuzumab|pertuzumab given as a loading dose of 840 mg IV on Day 1 followed by 420 mg IV every 3 weeks.
16090992|NCT02229149|Drug|Vinorelbine, Paclitaxel, Nab-Paclitaxel , Docetaxel, Capecitabine|"physician's choice of chemotherapy:
~Vinorelbine 25 mg/m2 IV weekly times 3 with 1 week off; OR
~Paclitaxel 80 mg/m2 IV weekly times 3 with 1 week off; OR
~Nab-Paclitaxel 100 mg/m2 IV weekly times 3 with 1 week off; OR
~Docetaxel 75 mg/m2 IV every 3 weeks; OR
~Capecitabine 1500 mg by mouth twice a day (PO BID) 14 days on and then 7 days off."
16090993|NCT02229136|Drug|Miracle Mouthwash Plus Hydrocortisone|Miracle Mouthwash Plus Hydrocortisone (16 oz recipe/480 ml)
16090994|NCT02229136|Drug|Prednisolone|Prednisolone oral solution 15 mg/5 ml
16090995|NCT02229123|Drug|Intravenous Levetiracetam|Open-study. If seizure lasting more than 3 minutes on EEG recording or brief repeated seizures (more or equal to 2 seizures lasting more than 20 seconds on a 1 hour-interval), the loading-dose of LEV allocated to patient is infused followed by the 8 maintenance dose.
16090996|NCT02229110|Other|Signal|Automatic signal in the electronic medical record
16090997|NCT02229097|Drug|Normal bolus|"During the normal bolus period, the bolus will be adjusted to the carbohydrate content of each meal and injected immediately. The basal rate will remain at a normal level during the 3 hours postprandial period"
16090998|NCT02229097|Drug|Coordinated bolus|The basal rate will be reduced at a rate of 0.1 U/h during the 3 h postprandial period. The insulin subtracted of the basal rate will be added to the normal bolus calculated for the meal and injected immediately.
16090999|NCT02229084|Biological|Chemovax - P10s-PADRE/ MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Docetaxel (or Paclitaxel)|Eligible subjects will be enrolled and immunized by SC administration of P10s-PADRE vaccine on each of 3 separate occasions over a three-week period.
16091000|NCT02229071|Drug|Donafenib(200mg)|Donafenib 200mg,bid,po
16091001|NCT02229071|Drug|Donafenib(300mg)|Donafenib 300mg,bid,po
16091002|NCT02229058|Drug|Albumin Bound Paclitaxel|120 mg/m2, D1,D8,every 3 weeks until disease progress or intolerable toxicity.
16091003|NCT02229058|Drug|S-1|40mg QD D1-D14,every 3 weeks,for BSA<1.25 m2, 50mg QD D1-D14,every 3 weeks,for BSA=1.25～1.5m2, 60mg QD D1-D14,every 3 weeks,for BSA>1.5m2,until disease progress or intolerable toxicity.
16091004|NCT02229045|Drug|Albumin Bound Paclitaxel|Albumin Bound Paclitaxel 150 mg/m2 (on day 1), every 2 weeks until disease progress or intolerable toxicity.
16091005|NCT02229045|Drug|5-FU|5-FU 400 mg/m2 iv d1, 2.4g/ m2 civ,d1-d3 every 2 weeks until disease progress or intolerable toxicity.
16091006|NCT02229019|Behavioral|Volunteer mealtime assistance|
16091007|NCT02229006|Radiation|18F-NaF PET-CT|
16091008|NCT02228980|Biological|Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation|0.25 mL Intramuscular (2 doses given 28 days apart)
16091009|NCT02228980|Biological|Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation|0.5 mL Intramuscular
16091010|NCT02228980|Biological|Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation|0.5 mL Intramuscular
16091011|NCT02228980|Biological|Shenzhen trivalent influenza vaccine (split virion, inactivated) North Hemisphere (NH) formulation|0.5 mL Intramuscular
16091012|NCT02228967|Behavioral|SBIRT|"SBIRT is an opportunistic approach whereby patients are screened by Health Educators for their alcohol use, and then, taking advantage of a teachable moment, are delivered a brief, motivational intervention matched to their level of risk."
16091013|NCT02228954|Procedure|Molecular imaging|
16091014|NCT02228928|Drug|CAPNP, 50 ug/cm2 capsaicin patch|
16091015|NCT02228928|Drug|CAPNP, 100 ug/cm2 capsaicin patch|
16091016|NCT02228928|Drug|0.075% capsaicin cream|
16091017|NCT02228928|Other|Placebo patch|
16091018|NCT02228902|Drug|Ferrous fumarate|one group receives ferrous fumarate (12 patients) and one group (12 patients) receives ferrous gluconate
16091019|NCT02228902|Drug|Ferrous gluconate|One group receives ferrous fumarate and one group receives ferrous fumarate.
16091020|NCT02228889|Procedure|Abdominal wall reconstruction with Strattice|Abdominal wall reconstruction using Strattice
16091021|NCT02228889|Other|Assess pain intensity at last office visit preoperatively|Assess patient pain intensity preoperatively using the PROMIS Pain Intensity survey (average of 1-3 weeks preoperatively)
16091022|NCT02228889|Other|Assess pain interference at last office visit preoperatively|Assess pain interference preoperatively using the PROMIS pain interference survey (average of 1-3 weeks preoperatively)
16091023|NCT02228889|Other|Assess physical functioning at last office visit preoperatively|Assess physical functioning preoperatively using the PROMIS physical functioning survey (average of 1-3 weeks preoperatively)
16091024|NCT02228889|Other|Assess patient quality of life at last office visit preoperatively|Assess patient quality of life preoperatively, using the HerQLes survey (average of 1-3 weeks preoperatively)
16091025|NCT02228889|Other|Assess patient pain intensity postoperatively|Assess patient pain intensity at 1 year postoperatively using the PROMIS Pain Intensity survey
16091026|NCT02228889|Other|Assess pain interference postoperatively|Assess pain interference at 1 year postoperatively using the PROMIS Pain Interference survey
16091027|NCT02228889|Other|Assess physical functioning postoperatively|Assess physical functioning at 1 year postoperatively using the PROMIS Physical Functioning Survey
16091028|NCT02228889|Other|Assess quality of life postoperatively|Assess quality of life at 1 year postoperatively using the HerQLes survey
16091029|NCT02228889|Other|Assess hernia recurrence at 30 days postoperatively|Assess hernia recurrence at 30 days
16091030|NCT02228889|Other|Assess bulge at 30 days postoperatively|Assess bulge at 30 days
16091031|NCT02228889|Other|Assess Surgical Site Occurrences at 30 days postoperatively|Assess Surgical Site Occurrences at 30 days
16091033|NCT02228889|Other|Assess bulge at 1 year postoperatively|Assess bulge at 1 year postoperatively
16091034|NCT02228889|Other|Assess Surgical Site Occurrences at 1 year postoperatively|Assess Surgical Site Occurrences at 1 year postoperatively
16091035|NCT02228889|Other|Assess overall complications at 30 days postoperatively|
16091036|NCT02228889|Other|Assess overall complications at 1 year postoperatively|
16091037|NCT02228889|Procedure|Abdominal wall reconstruction with XenMatrix|Abdominal wall reconstruction with XenMatrix
16091038|NCT02228889|Device|Strattice|Strattice mesh
16091039|NCT02228889|Device|XenMatrix|Xenmatrix mesh
16091040|NCT02228863|Other|Early Inmotion and Botox|Concomitant use of Inmotion and Botox from the baseline
16091041|NCT02228863|Other|Botox, then Inmotion|At baseline Botox injection and 4 weeks after Inmotion
16091042|NCT02228863|Other|Inmotion, then Botox|Inmotion from the baseline, then Botox injection at 4 weeks after baseline
16091043|NCT02228863|Other|Late Inmotion and Botox|No intervention until 4 weeks from the baseline. Then Inmotion and Botox injection
16091044|NCT02228850|Drug|Alprostadil|
16091045|NCT02228850|Other|Placebo|
16091046|NCT02228837|Dietary Supplement|Pear|
16091047|NCT02228837|Dietary Supplement|Placebo|
16091048|NCT02228824|Drug|Very low nicotine content cigarettes|0.07 mg nicotine delivery
16091049|NCT02228824|Drug|Normal nicotine content cigarettes|0.8 mg nicotine delivery
16091050|NCT02228811|Drug|DCC-2701 tablet|
16091051|NCT02228785|Biological|G17DT|
16091052|NCT02228772|Drug|MLN 9708|Patients will received standard chemotherapy as well as MLN 9708 in escalating doses.
16091053|NCT02228772|Drug|Vincristine|Standard chemotherapy dosage and duration
16091054|NCT02228772|Drug|Cytarabine|Standard chemotherapy dosage and duration
16091055|NCT02228772|Drug|Doxorubicin|Standard chemotherapy dosage and duration
16091056|NCT02228772|Drug|Mercaptopurine|Standard chemotherapy dosage and duration
16091057|NCT02228772|Drug|Cyclophosphamide|Standard chemotherapy dosage and duration
16091058|NCT02228772|Drug|Methotrexate|Standard chemotherapy dosage and duration
16091059|NCT02228759|Procedure|Adductor canal block|All patients will recieve fast tracking with reduced fasting times, multimodal analgesia and adductor canal block
16091060|NCT02228746|Dietary Supplement|Alpha-galacto-oligosaccharides|6g of alpha-galacto-oligosaccharides in a 100 mL flavored drink
16091061|NCT02228733|Drug|KBP-5074|Comparisons of different doses of study drug
16091062|NCT02228720|Device|Propel Nova Sinus Implant|Bioabsorbable, steroid-releasing sinus implant with 370 mcg of mometasone furoate released over 30 days
16091063|NCT02228707|Drug|BIIB061|Participants receive BIIB061
16091064|NCT02228707|Other|Placebo|Matched placebo
16091065|NCT02228681|Drug|Everolimus|10mg daily by mouth
16091066|NCT02228681|Drug|Tamoxifen|20 mg daily by mouth on alternating weeks (even numbered) weeks
16091067|NCT02228681|Drug|Letrozole|2.5mg once a day by mouth
16091068|NCT02228681|Drug|Medroxyprogesterone Acetate|200 mg daily by mouth
16091069|NCT02228655|Drug|FMX-8|
16091070|NCT02228629|Device|CrocsRx Medical Silver cloud clogs|
16091071|NCT02228616|Drug|Prucalopride|During the 12-week treatment phase of the study, the daily dose of 1 tablet of 2-mg prucalopride will be administrated orally before breakfast.
16091072|NCT02228616|Drug|Polyethylene glycol (PEG)|Optimized dose of PEG will be administrated for 13 weeks (1 week run-in+12 weeks intervention).
16091073|NCT02228616|Drug|Lactulose|Optimized dose of Lactulose will be administrated for 13 weeks (1 week run-in+12 weeks intervention).
16091074|NCT02228603|Behavioral|high-intensity exercise training|
16091075|NCT02228603|Behavioral|web-based follow-up program|
16091076|NCT02228603|Behavioral|usual care|
16091077|NCT02228590|Drug|APL-130277|Apomorphine Hydrochloride, Sublingual Thin Film
16091078|NCT02228564|Procedure|Percutaneous transluminal angioplasty (PTA)|"Percutaneous transluminal angioplasty (PTA) is a procedure that can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a balloon at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored."
16091079|NCT02228564|Device|LIFESTREAM™ covered stent|Implantation of the LIFESTREAM™ covered stent
16091080|NCT02228551|Other|Augmented renal clearance Point prevalence study|An 8-hour urine collection was carried out to determine the CrCl8h. Participants were asked to empty the bladder at the start of the collection. From then, patients were asked to collect urine in a recipient during the following 8 hours. If an indwelling transurethral or suprapubic urinary catheter was in situ, the collection bag was emptied at the start of the collection. After 8 hours, total urinary volumes (Uv8h) were measured with a measuring cup and urinary creatinine concentrations were determined by laboratory analysis. Midterm serum creatinine samples were obtained at 4 hours after the start of the urinary collection. Based on these values, CrCl8h was calculated according to the standard formulas and normalized to a body surface area (BSA) of 1.73m².
16091081|NCT02228538|Device|Total knee arthroplasty patients|ConforMIS iTotal (CR) knee implant system & off-the-shelf standard knee implant system from various manufacturers
16091082|NCT02228525|Drug|selinexor (KPT-330)|
16091083|NCT02228512|Drug|Pomalidomide|Part A: 5 mg po daily for 21 days (full course) Part A: 5 mg po daily for 4 days (short course) Part B: 5 mg po daily for 5 days (Phase I/II dose) Part C: Phase I/II dose) po daily Day 1-21 of 28 day cycle for up to 12 cycles.
16091084|NCT02228512|Drug|Rituximab|Part A: 375 mg/m2 day 22 (full course) Part A: 375 mg/m2 day 5 (short course) Part A: 375 mg/m2 day 1 (omit pomalidomode) Part B: 375 mg/m2 day 1
16091085|NCT02228512|Drug|Prednisone|Part B: 60 mg/m2/day po x 5 days (day 1-5
16091086|NCT02228512|Drug|Etoposide|Part B: 50 mg/m2/day CIVI over 24 hrs x 4 days
16091087|NCT02228512|Drug|Doxorubicin|Part B: 10 mg/m2/day CIVI over 24 hrs x 4 days
16091088|NCT02228512|Drug|Vincristine|Part B: 0.4 mg/m2/day CIVI over 24 hrs x 4 days
16091089|NCT02228512|Drug|Cyclophosphamide|Part B: 750 mg/m2 Day 5
16091090|NCT02228499|Other|Survey|We will be administering surveys about health, quality of life, and asking for final report cards for the 2013-2014 school year for each group.
16091171|NCT02227888|Drug|N91115|S nitrosoglutathione reductase inhibitor
16091091|NCT02228486|Device|tDCS|2 mA (verum group) over the left dorsolateral prefrontal cortex (F3, anodal), 15 min; 10 seconds ramp in verum and sham group (see also above)
16091092|NCT02228486|Behavioral|Cue Exposure Therapy|5 weeks (9 sessions) of cue-exposure therapy with preferred alcoholic beverage (see also above)
16091093|NCT02228473|Drug|Glycopyrrolate|Glycopyrrolate will be administered.
16091094|NCT02228473|Drug|Atropine|Atropine will be administered.
16091095|NCT02228460|Drug|GZ/SAR402671|Pharmaceutical form: Capsule; Route of administration: Oral
16091096|NCT02228447|Behavioral|Healthy Habits, Healthy Girls Group|The intervention group will receive a 6-month multicomponent intervention (i.e., enhanced physical education classes; interactive seminars; nutrition workshops; text messages; and parents newsletters) and materials (i.e., nutrition and PA handbooks; cooking books; Choreographies CDs and PA leadership handbook).
16091097|NCT02228434|Behavioral|Monitoring and Tailored prescription|
16091098|NCT02228434|Behavioral|Happy 10 program|
16091099|NCT02228434|Behavioral|Specified nutrition education|
16091100|NCT02228434|Behavioral|General Health Education|
16091101|NCT02228408|Drug|Hydralazine/Isorsorbide Dinitrate|"Hydralazine/Isorsorbide Dinitrate (ISD/HY) will be administered with a target dose of 40 mg of ISD and 75 mg of Hydralazine 3x/daily. Doses will be titrated between weeks 0-4 and may be decreased as necessary for treatment of adverse events.
~Target Dose:
~Hydralazine 75 mg 3x day Isorsorbide Dintrate 40 mg 3x/day
~Allowable Dosage Forms:
~ISD/HY 10 mg/10-3x/day ISD/HY 20 mg/35 mg-3x/day ISD/HY 40 mg/75 mg-3x/day
~Dose Titration:
~ISD/HY will be administered at a starting dose ISD/HY 10 mg/10-3x/day and titrated to ISD/HY 20 mg/35 mg-3x/day after 4 days and to ISD/HY 40 mg/75 mg-3x/day at 4 weeks. Dose will be decreased as necessary for dose-limiting side effects."
16091102|NCT02228408|Drug|Placebo|Placebo titration will mimic titration of active study arm
16091103|NCT02228395|Drug|PF-04958242|Administered as specified in treatment arm
16091104|NCT02228395|Drug|Placebo|Administered as specified in treatment arm
16091105|NCT02228382|Drug|Bosutinib|100 mg and 500 mg tablets, once daily dosage up to 4 years duration
16091106|NCT02228369|Drug|AZD3759|Starting dose 50 mg, administered twice daily. If tolerated subsequent cohorts will test increasing doses of AZD3759, until a maximum tolerated dose or an effective dose is defined
16091107|NCT02228369|Drug|AZD9291|AZD9291 160mg once daily
16091108|NCT02228356|Radiation|Stereotactic Body Radiation Therapy|Stereotactic Body Radiation Therapy with either Dynamic Tumor Tracking/Internal Target Volume approach on the Vero machine, and/or Internal Target Volume approach on the Tomotherapy machine.
16091109|NCT02228343|Other|Ayurveda|Ayurveda includes meditation, yoga, breathing exercises, herbs
16091110|NCT02228330|Procedure|obturator nerve block|a uni-lateral obturator nerve block will be performed under ultrasound guidance- using 2% lidocaine for obtaining a short term block.
16091111|NCT02228317|Device|Telemedicine consultation|Telemedicine consultation done by telephone or video
16091112|NCT02228304|Drug|NT-503-3 ECT implantation|NT-503-3 ECT implantation is a biological sustained drug delivery device that could provide continuous delivery of an anti-VEGF therapy
16091113|NCT02228304|Drug|Eylea® injected intravitreally administered every 8 weeks|The first part, stage 1, Phase I is open label with the experimental treatment arm only. Eylea® injected intravitreally is only used as a comparator in the stage 2, Phase II, portion of the study.
16091114|NCT02228291|Dietary Supplement|Capsule containing citrus flavonoid|
16091115|NCT02228291|Dietary Supplement|Placebo|
16091116|NCT02228278|Behavioral|Group A|"Phase 1: Group A will receive the typical clinic visits plus daily text messages for 12 weeks.
~Phase 2: Group A will receive the typical clinic visits (which includes anthropometric measures every three months, counseling on physical activity and nutrition goals by a healthcare provider and for those prescribed medication for a chronic condition, medication counseling by a healthcare provide) plus daily text messages in between visits for 3 months to support their health goals."
16091117|NCT02228278|Other|Group B|"Phase 1: Group B will receive current standard care - clinic visits every three months anthropometric assessments and counseling on physical activity and nutrition goals by a healthcare provider, typically with no patient-provider communication between visits.
~Phase 2: Group B will initially act as the control and will receive the typical clinic visits (which includes anthropometric measures every three months, counseling on physical activity and nutrition goals by a healthcare provider, and for those prescribed medication for a chronic condition, medication counseling by a healthcare provider) with typically with no patient-provider communication between visits. After a 6-month delay, Group B will then receive the intervention which includes the typical clinic visits as stated previously plus daily text messages in between visits for 3 months to support their health goals."
16091118|NCT02228265|Other|Cytology Specimen Collection Procedure|Undergo blood and tissue collection
16091119|NCT02228265|Drug|Enzalutamide|Given PO
16091120|NCT02228265|Other|Laboratory Biomarker Analysis|Correlative studies
16091121|NCT02228252|Other|Whey protein|
16091122|NCT02228252|Other|Casein|
16091123|NCT02228252|Other|Gluten protein|
16091124|NCT02228239|Drug|Esketamine|Esketamine 84 milligram (mg) [3*1 of spray in each nostril] will be administered intranasally on Day 1 in one of the treatment periods.
16091125|NCT02228239|Drug|Mirtazapine|Mirtazapine 30 mg capsule will be administered orally on Day 1 in one of the treatment periods.
16091126|NCT02228239|Drug|Placebo (Matched to Esketamine)|Placebo [3*1 in each nostril] will be administered intranasally on Day 1 in one of the treatment periods.
16091127|NCT02228239|Drug|Placebo (Matched to Mirtazapine)|Placebo capsule will be administered orally on Day 1 in one of the treatment periods.
16091128|NCT02228213|Biological|MIS416|Intravenous administration weekly for 52 weeks
16091129|NCT02228213|Drug|Saline|Intravenous administration weekly for 52 weeks
16091172|NCT02227875|Drug|Mylan's insulin glargine|Patients who are randomized to receive Mylan's insulin glargine during the comparative phase will receive the same dose as the dose of Lantus® received during the screening period. The recommended starting dose of Mylan's insulin glargine or Lantus®, in patients with T2DM who are not currently treated with insulin is 10 units (or 0.2 Units/kg) once daily, which should subsequently be adjusted every week if essential.
16091678|NCT02224144|Drug|Calcitriol|Calcitriol (Rocaltrol) 0.5 mcg per day for 12 months
16091130|NCT02228200|Behavioral|Nurse-led care|The nurse-led care consisted of a pre-chemotherapy nursing consultation and telephone follow-up sessions during chemotherapy. The nursing consultation was on the day of the first cycle before drug administration. It included: history review, overall status evaluation, need and problem assessment, information provision, psychological support, and referral. The telephone follow-up sessions were delivered within one week after the 1st, 2nd, 4th, and 6th, and 8th cycle. A telephone follow-up session included: (i) The overall status assessment and problem triage; (ii) Care delivery based on problem severity; (iii) Evaluation of the change of the problems on the following telephone call.
16091131|NCT02228200|Behavioral|Routine care|Routine care includes: (1) Brief education on possible side-effects and coping skills before chemotherapy; (2) Care on chemotherapy day: vital sign assessment, casual communication between nurses and patients, video about chemotherapy and side effects management. (3) Care in chemotherapy intervals: hotline for patients when they have health problems at home.
16091132|NCT02228187|Device|Brain-Computer Interface|Brain-computer Interface (BCI) is a direct communication pathway between a human brain and an external device. It is a technology that enables people to interact with computers through their thoughts. Electroencephalography (EEG) is the best studied non-invasive interface facilitating such communication. The BCI system will take EEG recordings from the prefrontal cortex to determine the participants' state of attention with high specificity. The training program developed using this patented technology may be useful for individuals who experience difficulty with memory and sustaining their attention.
16091133|NCT02228174|Device|Intrauterine Ultrasound-Guided Radiofreq. Ablation System|The Sonata System combines intrauterine ultrasound (IUUS) with radiofrequency (RF) ablation in a single handpiece. Sonata is suitable in an inpatient or outpatient setting, and is intended for diagnostic intrauterine imaging and transcervical treatment of symptomatic uterine fibroids, including those associated with heavy menstrual bleeding(HMB).
16091134|NCT02228161|Behavioral|Yoga|Yoga group will receive regular 60-minutes yoga classes twice a week for 3 months.
16091135|NCT02228148|Device|NFS|Cochlear Nucleus Fitting Software
16091136|NCT02228148|Device|CSS|Cochlear Nucleus Custom SoundTM Suite
16091137|NCT02228135|Drug|Dexamethasone|
16091138|NCT02228122|Device|Aquacel® Ag+ Extra|Aquacel® Ag+ Extra dressing will be applied to wounds as per instructions for use, dressing to be changed at least one per week for 4 weeks.
16091139|NCT02228109|Device|Acuvue Oasys for Presbyopia|Acuvue Oasys for Presbyopia contact lenses worn
16091140|NCT02228109|Device|PureVision2 for Presbyopia|PureVision2 for Presbyopia contact lenses worn
16091141|NCT02228109|Device|Biofinity Multifocal|Biofinity Multifocal contact lenses worn
16091142|NCT02228096|Biological|CTL019 T-cells|A target dose of CTL019 transduced cells will consist of a single infusion of 2.0 to 5.0 x 10^6 CTL019 transduced cells per kg body weight (for patients ≤ 50 kg) and 1.0 to 2.5 x 10^8 CTL019 transduced viable T cells (for patients > 50 kg). The following cell dose ranges may be infused if all other safety release criteria are met: 0.2 to 5.0 x 10^6 CTL019 transduced viable T cells per kg body weight (for patient ≤ 50 kg) and 0.1 to 2.5 x 10^8 CTL019 transduced viable T cells (for patients > 50 kg).
16091143|NCT02228083|Drug|Lidocaine with epinephrine|Lidocaine without vasoconstrictor , lidocaine with epinephrine 1:100,000
16091144|NCT02228070|Device|strabismus video goggles|
16091145|NCT02228044|Behavioral|Prevention program|
16091146|NCT02228031|Drug|Oxytocin|The experimental oxytocin group will receive 24 international units (IU) of oxytocin using an intranasal administration (self-administered nasal spray) one time before the experimental session
16091147|NCT02228031|Other|Placebo|The placebo comparator group will receive sterile saline through intranasal administration, consisting of the same salt solution in which the hormone will be dissolved , but lacking the hormone itself.
16091148|NCT02228018|Device|CT-scan|CT-Scan will be taken at visit 1 on FRC and TLC breathing levels
16091149|NCT02228005|Drug|Sertraline|Protocolized titration from 50 to max 200mg based on response and tolerance.
16091150|NCT02227992|Biological|EVARREST™ Sealant Matrix|EVARREST® Fibrin Sealant Patch is a sterile, bio-absorbable combination product, comprised of two biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component.
16091151|NCT02227992|Device|SURGICEL®|SURGICEL® Absorbable Hemostat is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
16091152|NCT02227979|Behavioral|The Purple Cry Intervention|This intervention consists of an 11-page booklet and 12-minute DVD produced by the National Center on Shaken Infant Syndrome.
16091153|NCT02227979|Behavioral|Control Intervention|This intervention consist of 1 brochure and a DVD on infant safety excerpted from the Safe Start video on infant safety.
16091154|NCT02227966|Device|Yband (YDT-201N)|transcranial Direct Current Stimulation (tDCS) 2mA for 30 min; 20 sec of ramp-up and -down; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)
16091155|NCT02227966|Device|Sham-Yband (YDT-201N)|tDCS 2mA for 20 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex
16091156|NCT02227953|Device|Yband (YDT-201N)|transcranial Direct Current Stimulation (tDCS) 2mA for 30 min; 20 sec of ramp-up and -down; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)
16091157|NCT02227953|Device|sham-Yband (YDT-201N)|transcranial Direct Current Stimulation (tDCS) 2mA for 20 sec; left (anode) and right (cathode) Dorsolateral prefrontal cortex (DLPFC)
16091158|NCT02227940|Drug|Ceritinib|Given PO
16091159|NCT02227940|Drug|Cisplatin|Given IV
16091160|NCT02227940|Drug|Gemcitabine Hydrochloride|Given IV
16091161|NCT02227940|Other|Laboratory Biomarker Analysis|Correlative studies
16091162|NCT02227940|Drug|Paclitaxel Albumin-Stabilized Nanoparticle Formulation|Given IV
16091163|NCT02227940|Other|Pharmacological Study|Correlative studies
16091164|NCT02227927|Drug|Domperidone|10-30mg oral dose, four times daily.
16091165|NCT02227914|Drug|Oprozomib|Study subjects will receive oprozomib tablets once a day on Days 1, 2, 8, 9, 15, 16, 22 and 23 of a 28 day cycle
16091166|NCT02227914|Drug|Sorafenib|Study subjects will receive sorafenib tablets twice a day for Days 1-28
16091167|NCT02227901|Drug|Tipifarnib|Given PO
16091168|NCT02227901|Radiation|External Beam Radiation Therapy|Undergo EBRT
16091169|NCT02227901|Drug|Temozolomide|Given PO
16091170|NCT02227901|Other|Laboratory Biomarker Analysis|Correlative studies
16091173|NCT02227875|Drug|Lantus®|For patients who are randomized to receive Lantus® during the comparative phase the dose of Lantus® will be equal to the dose received during the screening period.
16091174|NCT02227862|Drug|Mylan's insulin glargine|All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period, and will continue on this for the complete trial. During the 6 week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.
16091175|NCT02227862|Drug|Lantus®|All patients will be shifted from their current mealtime insulin to insulin lispro at the start of the run-in period; and will continue on this for the complete trial. During the 6week run-in period the doses of Lantus® and insulin lispro will be titrated (if required) to ensure diabetes control. After the run-in period, patients will be randomized to receive either Mylan's insulin glargine (in place of Lantus®), or to continue on Lantus®. During the period from 12 to 24 weeks dose titration will be kept to a minimum.
16091176|NCT02227849|Drug|Canagliflozin (TA-7284)|The patients will receive Canagliflozin orally for 52 weeks
16091177|NCT02227849|Drug|GLP-1 analogue|
16091178|NCT02227836|Device|Allergy Patch Testing|
16091179|NCT02227823|Drug|Pyridostigmine Bromide|
16091180|NCT02227810|Other|electrical stimulation (high frequency)|Participants will receive muscular electrical stimulation (75Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days
16091181|NCT02227810|Other|electrical stimulation (low frequency)|Participants will receive muscular electrical stimulation (35Hz) on quadriceps muscle for 20 min/session, twice daily for 10 days.
16091182|NCT02227810|Other|sham group|Participants will receive similar electrical stimulation (ES) procedure as those in intervention group but with ES machine power off.
16091183|NCT02227797|Drug|Voriconazole|6 mg/kg to 12 mg/kg IV/PO every 12 hours depending on patient age and dose toleration of prior patients
16091184|NCT02227784|Drug|Evacetrapib|Administered orally
16091185|NCT02227784|Drug|Atorvastatin|Administered orally
16091186|NCT02227784|Drug|Ezetimibe|Administered orally
16091187|NCT02227784|Drug|Placebo|Administered orally
16091188|NCT02227771|Device|Percutaneous coronary intervention|
16091189|NCT02227745|Drug|Dorzolamide hydrochloride (2%)|"Subsequently photocoagulation treatment was applied according to the guidelines of the ETDRS, reevaluate the patient at 4 weeks.
~Patient 1 drop of topical drug in the treaty provided every 8 hours for 4 weeks eye and again 4 weeks after cited for evaluation will be placed"
16091190|NCT02227745|Drug|Placebo Sodium hyaluronate 4mg|"Intervention: Subsequently photocoagulation treatment was applied according to the guidelines of the ETDRS, reevaluate the patient at 4 weeks.
~Patient 1 drop of topical drug in the treaty provided every 8 hours for 4 weeks eye and again 4 weeks after cited for evaluation will be placed."
16091191|NCT02227732|Device|New Indwelling Pleural Catheter|Placement of an indwelling catheter in the pleural space. Drainage of effusions until resolution.
16091192|NCT02227719|Device|CTI|CTI is the titanium mesh
16091193|NCT02227719|Device|Collagen membrane|
16091194|NCT02227706|Biological|EVICEL® Fibrin Sealant|EVICEL® is a human plasma-derived fibrin sealant. EVICEL® consists of two components: a concentrate of Human Clottable Protein (referred to as Biological Component 2; BAC2) and a solution of Human Thrombin. No material of animal origin is present in the product
16091195|NCT02227706|Device|SURGICEL® Absorbable Hemostat|SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is a sterile absorbable knitted fabric prepared by the controlled oxidation of regenerated cellulose.
16091196|NCT02227693|Drug|avatrombopag|E5501 (avatrombopag) 20-mg tablets
16091197|NCT02227693|Drug|Placebo|Placebo matching 20-mg tablets
16091198|NCT02227680|Other|Music Therapy|Each music therapy session will begin with a brief description of the protocol, a musical introduction, a discussion of music preferences, and an informal assessment of participant needs to determine target goals, e.g., management of pain, anxiety, and other symptoms; breath control; emotional support and regulation. After the initial visit, the music therapist will create a playlist, based on participant preferences, and burn it onto a CD for the participant. The participant will be encouraged to use the book and listen to the CDs as often as he/she would like. After the initial visit, follow up visits will include techniques like music-facilitated breathing, music and imagery, music and relaxation/meditation, song writing, improvisation, singing, lyric substitution, lyric analysis, musical reminiscence, passive listening. There will be the opportunity to create music and write songs across multiple sessions, if these activities are indicated.
16091199|NCT02227680|Other|Massage Therapy|Working with experts in hospital-based massage therapy, we have developed a semi-standardized inpatient massage protocol that utilizes Swedish techniques and acupressure. The protocol was adapted from our successful previous study of massage for perioperative care of patients undergoing implantation of permanent intravenous access devices. Massage therapists will focus on hands, feet, arms, and neck, as able, during the treatments.
16091200|NCT02227667|Drug|MEDI4736|Patients will be seen the day of administration of MEDI4736. A medical history, with particular reference to toxicities, including medication review, and physical examination will be conducted at each treatment visit.
16091201|NCT02227654|Procedure|Abnormal Ovarian Ultrasound|Ultrasound
16091202|NCT02227641|Biological|CMV/EBV specific T-cell|Peptide stimulated allogeneic T-cells with dual specificity for CMV and EBV
16091203|NCT02227628|Dietary Supplement|Acai polyphenolics|Acai beverage was obtained from the Sambazon (San Clemente, CA).
16091204|NCT02227628|Dietary Supplement|Sugary Beverage|An equal amount of placebo juice comprised of artificially colored water containing sugar (5%), citric acid (0.01% to adjust the pH 3.8), and artificial colors (FD&C Red 40 and Blue 1, Tetra Pak, Denten, TX) that was identical to the acai beverage.
16091205|NCT02227615|Dietary Supplement|Mango polyphenolics|Frozen Mango (Keitt) packs provided to subjects.
16091206|NCT02227615|Dietary Supplement|Sugary beverage|15.7g sugar, 3.8g pectin and 0.05g citric acid was added in 100ml of the control beverage.
16091207|NCT02227602|Drug|Mango polyphenolics|Frozen mango pack will be provided (200~400g per day).
16091679|NCT02224144|Drug|Placebo|Placebo (sugar pill) 1 pill per day for 12 months
16093174|NCT02213289|Drug|Nivolumab|Nivolumab
16091208|NCT02227589|Behavioral|MET/CBT-12|Two sessions of motivation enhancement therapy followed by 10 sessions of cognitive behavior therapy targeting alcohol or cannabis abuse. These 12 sessions will be delivered over 12 to 14 weeks.
16091209|NCT02227589|Behavioral|CBT-D|CBT-D consists of seven weekly sessions of cognitive behavior therapy targeting depression.
16091210|NCT02227589|Other|D-TAU|D-TAU is treatment as usual in the community, targeting depression. It may consist of medication and/or behavioral intervention.
16091211|NCT02227576|Drug|Romiplostim|
16091212|NCT02227563|Device|Active tDCS|repetitive daily tDCS sessions for a period of one week
16091213|NCT02227563|Device|control|
16091214|NCT02227550|Drug|Vitamin K antagonist|any locally used VKA, INR 2-3, min. 30 days according to aplicable medical guidelines and local clinical routin
16091215|NCT02227550|Drug|Apixaban|factor Xa inhibitor Apixaban min. 30 days 5 mg twice daily (fix dose) dose reduction Apixaban 2,5 mg twice daily in patients who fulfill tow of the following criteria at the time of randomisation: chronic kidney disease (serum creatine >= 1.5 mg/dl (133mM), <= 60 kg body weight or age >= 80 years.
16091216|NCT02227537|Device|Providence Nighttime Bracing System|Providence Nighttime Bracing System
16091217|NCT02227537|Device|Providence Nighttime Bracing System|The Providence brace is a polypropylene plastic, acrylic framed, system designed to apply corrective forces to scoliatic curves achieving correction or reduction of scoliosis.
16091218|NCT02227524|Other|No device|Compare walking function and ability in a sample of persons with MS under four different assistive device conditions: no device, single-point cane (SPC), four-point cane (FPC) and trekking pole (TP).
16091219|NCT02227524|Device|Single-point cane (SPC)|Compare walking function and ability in a sample of persons with MS under four different assistive device conditions: no device, single-point cane (SPC), four-point cane (FPC) and trekking pole (TP).
16091220|NCT02227524|Device|Four-point cane (FPC)|Compare walking function and ability in a sample of persons with MS under four different assistive device conditions: no device, single-point cane (SPC), four-point cane (FPC) and trekking pole (TP).
16091221|NCT02227524|Device|Trekking pole (TP).|Compare walking function and ability in a sample of persons with MS under four different assistive device conditions: no device, single-point cane (SPC), four-point cane (FPC) and trekking pole (TP).
16091222|NCT02227511|Dietary Supplement|Fruits|Randomization to extra fruit or nuts as snacks
16091223|NCT02227511|Dietary Supplement|Nuts|
16091224|NCT02227498|Device|Effect of Argus II on Functional Vision|To evaluate the safety and effectiveness of the Argus II Retinal Prosthesis in subjects with AMD.
16091225|NCT02227485|Drug|Punica granatum Pleniflora (Golnaar) mouth rinse|"All the patient in intervention group use 10 ml of Golnaar mouth rinse for 2 minutes every night for 2 weeks."
16091226|NCT02227485|Drug|Chlorhexidine (0.2%)|All the patient in control group use 10 ml of chlorhexidine (0.2%) for 2 minutes every night for 2 weeks.
16091227|NCT02227485|Procedure|Tooth bleaching|Tooth bleaching for both groups one time after using mouth rinses.
16091228|NCT02227472|Other|Evaluation of cognitive and pre-academic skills|Participants will complete testing to evaluate fluid reasoning, knowledge, quantitative reasoning, visual-spatial processing, verbal and non-verbal working memory, and knowledge of pre-academic skills (such as colors, letters, numbers, counting, sizes, comparisons, and shapes).
16091229|NCT02227472|Other|Parent questionnaires|Parents will complete questionnaires to assess behavioral manifestation of executive functions, functional independence and adaptive functioning, child and parent characteristics, situational/demographic life stress, demographics, education level, and household income.
16091230|NCT02227459|Drug|ND-L02-s0201 Injection|
16091231|NCT02227446|Drug|Vancomycin antibiotic powder|At the time of fracture fixation 1000 mg of Vancomycin powder placed into the wound during wound closure.
16091232|NCT02227433|Drug|Brentuximab Vedotin|
16091233|NCT02227420|Drug|Anakinra|Anakinra 100mg s.c. x 5
16091234|NCT02227407|Device|RGOs(reciprocating gait orthoses)|using additional apparatus combined with Hip-Knee-Ankle-Foot orthoses (HKAFO) to help paraplegia patients to present reciprocating gait pattern
16091235|NCT02227394|Drug|Z7200|"Total dose budesonide/formoterol is 160 mcg/4.5 mcg) to be administered only with the inhaler device (RS-01).
~At visit 2 or 3 (cross-over design)"
16091236|NCT02227394|Drug|Symbicort® Turbohaler®|Total dose budesonide/formoterol is 320 mcg/9 mcg. At visit 2 or 3 (cross-over design)
16091237|NCT02227394|Drug|Placebo of Test product|"Single dose of 2 puffs
~Z7200 inhalation powder placebo is filled in size 3 hydroxypropyl methylcellulose (HPMC) capsules.
~At visit 2 or 3 (cross-over)
~To ensure blinding, each patient will receive two inhalers (one active and one placebo) on each dosing day."
16091238|NCT02227394|Drug|Placebo of Reference Drug|"Single dose of 2 puffs
~Symbicort placebo does not contain any drug substances, (Budesonide and Formoterol fumarate), or excipients (Lactose monohydrate).
~At visit 2 or 3 (cross-over)
~To ensure blinding, each patient will receive two inhalers (one active and one placebo) on each dosing day."
16091239|NCT02227394|Radiation|Functional Respiratory Imaging|CT-scan of thorax, at visit 2 pre and postdose and at visit 3 pre and postdose.
16091240|NCT02227368|Drug|Ticagrelor|Antiplatelet therapy approved for ACS. Antagonist of P2Y12 and inhibitor of adenosine diphosphate (ADP)-induced platelet aggregation.
16091241|NCT02227368|Drug|Comparator|Aspirin monotherapy anti-platelet treatment for PAD patients following EVR procedures
16091242|NCT02227342|Biological|Fecal Microbiota Transplant|serial FMT
16091243|NCT02227329|Drug|Ethanol|Prophylactic ELT will be administered at the time when the HPN is not being infused.
16091244|NCT02227329|Drug|Heparin Lock|3 mL of 100 U/ml heparin
16091245|NCT02227329|Drug|Normal Saline|
16091246|NCT02227316|Drug|IV Ibuprofen|Uterine fibroid embolization
16091247|NCT02227316|Drug|IV Acetaminophen|Uterine fibroid embolization
16091248|NCT02227316|Drug|Intravenous placebo/Intravenous placebo|Uterine fibroid embolization
16091249|NCT02227303|Behavioral|lifestyle modification instructional and motivational sessions|
16091250|NCT02227290|Drug|Naftin Cream|
16091251|NCT02227290|Drug|Placebo Cream|
16091393|NCT02226237|Procedure|group of pelvic floor exercises|contraction of the pelvic floor muscles sustained for 5 seconds, hip adductors using pillow and elevation of the hip, 30 repetitions of each exercise
16091252|NCT02227277|Drug|Peg-IFN-α2b|"Arm 1: At week 4 of the treatment, ART will be interrupted. Viral load will be monitored every 2 weeks. ART will be resumed at the earlier of a) a single measurement of VL > 50 c/ml or b) 16 weeks of treatment, and subjects will be observed for the remaining 4 weeks (total of 20 weeks on treatment).
~Arm 2: In week 4, participants in arm 2 will add peg-IFN-α-2b to their ART regimen for a period of 20 weeks."
16091253|NCT02227264|Drug|Cinacalcet|Cinacalcet, Mimpara® 30mgx1-2 for 4 weeks
16091254|NCT02227264|Procedure|parathyroid adenomectomy|surgical removal of pathologic parathyroid tissue
16091261|NCT02227212|Drug|Insulin glargine U300 (new formulation of insulin glargine) HOE901|Pharmaceutical form:solution for injection Route of administration: subcutaneous
16091262|NCT02227199|Drug|Brentuximab Vedotin|Given IV
16091263|NCT02227199|Drug|Carboplatin|Given IV
16091264|NCT02227199|Drug|Etoposide|Given IV
16091265|NCT02227199|Drug|Ifosfamide|Given IV
16091266|NCT02227199|Other|Laboratory Biomarker Analysis|Correlative studies
16091267|NCT02227186|Other|School-located Influenza Vaccination Clinic|Children in the intervention arm are enrolled in schools in Monroe County, NY that are offering school-located influenza vaccination clinics during school hours
16091268|NCT02227173|Drug|BMS-986020|
16091269|NCT02227173|Drug|Montelukast|
16091270|NCT02227173|Drug|Flurbiprofen|
16091271|NCT02227173|Drug|Digoxin|
16091272|NCT02227160|Behavioral|10 weekly group meetings|10 weekly group meetings with up to five other men and women at Grady Health System
16091273|NCT02227160|Behavioral|Outpatient counseling and support groups|Usual mental health care
16091274|NCT02227147|Drug|rhNGF 20µg/ml|
16091275|NCT02227147|Other|Placebo|Formulation containing antioxidant
16091276|NCT02227134|Procedure|Ultrasound|Ultrasound to measure hyo-mental distance, tonsil size and width of the tongue.
16091277|NCT02227121|Device|Defibrillation following induction of VT/VF|Up to 10 VT/VF induction attempts followed by shock(s) delivered by an externally placed ICD and/or external defibrillator.
16091278|NCT02227108|Drug|Moxetumomab Pasudotox|Participants received 6 doses of moxetumomab pasudotox 40 microgram per kilogram (mcg/kg) intravenous infusion over 30 minutes every other day (Days 1, 3, 5, 7, 9, and 11) in 21-day treatment cycles until completion of a maximum of 6 cycles of therapy.
16091279|NCT02227095|Behavioral|Exercise|Heart rate monitors worn by each child at each session
16091280|NCT02227095|Behavioral|After-school program|Supervised recreational program with token economy
16091281|NCT02227082|Radiation|radiotherapy|The whole breast and regional lymph nodes will receive 23 x 2.03 Gy per fraction (total 46.69 Gy) At the macroscopic tumor a added SIB will be given of 23 x 0.63Gy . Total dose: 61.18 Gy
16091282|NCT02227082|Drug|olaparib|The pre-defined dose levels of olaparib are 25mg QD, 25, 50, 100, 200, 300 and 400 mg BID
16091283|NCT02227069|Drug|M518101|
16091284|NCT02227069|Drug|M518101 Vehicle|
16091285|NCT02227069|Other|sodium lauryl sulfate|
16091286|NCT02227069|Other|saline|
16091287|NCT02227056|Drug|Methylphenidate|On three different days each participant will receive Methylphenidate in a dosage of 0.3 milligram/kilo rounded to the nearest full milligram dosage
16091288|NCT02227030|Drug|BIIB 722 CL solution|
16091289|NCT02227030|Drug|BIIB 722 CL tablet|
16091290|NCT02227030|Drug|Placebo solution|
16091291|NCT02227030|Drug|Placebo tablet|
16091292|NCT02227017|Drug|TPV capsule|
16091293|NCT02227017|Drug|TPV solution|
16091294|NCT02227017|Drug|RTV capsule|
16091295|NCT02227017|Drug|RTV solution|
16091296|NCT02227017|Other|standard meal|
16091297|NCT02227004|Diagnostic Test|Perform MRI in patients with pacemaker or ICD|Perform MRI in patients with pacemaker or ICD
16091298|NCT02226991|Drug|Tipranavir|
16091299|NCT02226991|Drug|Ritonavir|
16091300|NCT02226991|Drug|Efavirenz|
16091301|NCT02226978|Drug|Tipranavir|
16091302|NCT02226978|Drug|Ritonavir|
16091303|NCT02226978|Drug|Valaciclovir|
16091304|NCT02226965|Drug|PNT2258|
16091305|NCT02226952|Drug|BILN 2061 W, low dose|
16091306|NCT02226952|Drug|BILN 2061 W, medium dose|
16091307|NCT02226952|Drug|BILN 2061 W, high dose|
16091308|NCT02226952|Drug|Placebo|
16091309|NCT02226939|Drug|BILN 2061 ZW|
16091310|NCT02226939|Drug|Placebo|
16091311|NCT02226926|Drug|Aggrenox|
16091312|NCT02226926|Drug|Persantin Retard|
16091313|NCT02226926|Drug|Acetylsalicylic acid|
16091314|NCT02226913|Drug|2% lidocaine with 1:80,000 epinephrine|2% lidocaine with 1:80,000 epinephrine
16091315|NCT02226913|Drug|sodium bicarbonate|8.4% sodium bicarbonate
16091316|NCT02226913|Drug|placebo|sterile distilled water (Samen Pharmaceutical Co, Iran)
16091317|NCT02226900|Procedure|Hybrid Revascularization|Off-pump LIMA connected to the left anterior descending artery followed by percutaneous coronary intervention with drug eluting stents to the other territories.
16091318|NCT02226900|Procedure|Conventional Coronary Artery Bypass Surgery|On pump coronary artery by-pass surgery
16091450|NCT02225756|Drug|Cyclosporine A|Oral administration for a short time of cyclosporine A dose 1
16091451|NCT02225756|Drug|Cyclosporine A|Oral administration for a short time of cyclosporine A dose 2
16091319|NCT02226887|Procedure|MESH|"Pre-operative :
~It was made by barium enema protocol and transanal endoscopy to rule out anastomotic leaks or strictures contraindicating stoma closure .
~Surgical technique:
~Peristomal incision with electrocautery
~Release the handle of ileum
~Anastomosis made the with the segment everted sutured by simple manual end to end 3/0 or mechanical side to side (surgeon's election).
~Return the ileum into the abdominal cavity and the fascial defect is repaired with continuous polydioxanone 1/0 suture respecting 4:1 measurement rule.
~We add the mesh between the edges of the defect during fascia closure.
~The skin is sutured purse string style.
~Post-Op
~Hospital discharge after verification of normal digestive transit."
16091320|NCT02226887|Procedure|NO MESH|"Pre-operative :
~It was made by barium enema protocol and transanal endoscopy to rule out anastomotic leaks or strictures contraindicating stoma closure .
~Surgical technique:
~Peristomal incision with electrocautery
~Release the handle of ileum
~Anastomosis made the with the segment everted sutured by simple manual end to end 3/0 or mechanical side to side (surgeon's election).
~Return the ileum into the abdominal cavity and the fascial defect is repaired with continuous polydioxanone 1/0 suture respecting 4:1 measurement rule.
~The skin is sutured purse string style.
~Post-Op
~- Hospital discharge after verification of normal digestive transit"
16091321|NCT02226887|Radiation|Post-operative Imaging|Abdominal Tomography 1 year after ileostomy closure
16091322|NCT02226887|Radiation|Pre-operative Imaging|Contrast study is used to ensure the integrity of the distal anastomosis
16091323|NCT02226887|Other|Blood Test and C-reactive protein at 4th day|All patients undergo a Blood Test study of C-reactive protein on day 4 by protocol within the unit before discharge.
16091324|NCT02226861|Device|CliniMACS CD34 selection system|Stem cells will be selected with the CliniMACS system before transplant.
16091325|NCT02226861|Biological|ULD IL-2|sterile, white to off-white, preservative-free, lyophilized powder suitable for IV infusion upon reconstitution and dilution
16091326|NCT02226848|Drug|Erythropoeitin|
16091327|NCT02226809|Device|Accelerometry|Application of TOF stimulus (40 mA, three to four times) and recording TOFr in the PACU
16091328|NCT02226796|Device|Transcranial direct current stimulation|Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation tool that presents a low current that induces bi-directional polarity-dependent changes in the cortex to facilitate focal, prolonged shifts in cortical excitability at or around the time stimulation is provided. Anodal tDCS (a-tDCS), in which the positively charged electrode is placed over the targeted cortical region, has been shown to increase cortical excitability (upregulation), similar to long-term potentiation (LTP). Combining a-tDCS with behavioral-based approaches has been suggested to enhance the learning process and increase the likelihood of retention.
16091329|NCT02226783|Drug|AZD1722 salt tablet|AZD1722 will be administered as 14 mg (salt tablet). tablet for oral use. Subjects will receive a 14 mg tablet in the morning and evening on Days 1 to 4 (Period 1), Days 7 to 10 (Period 2), and Days 13 to 16 (Period 3).
16091330|NCT02226783|Drug|AZD1722 free base tablet|AZD1722 will be given as four 14 mg free-base tablets (56mg) in the morning and evening on Days 1 to 4 (Period 1) and Days 10 to 13 (Period 2).
16091331|NCT02226783|Drug|AZD1722 free base tablet + Omeprazole|AZD1722 free base tablet administered 5 to 10 minutes before intake of breakfast and evening dose 5 to 10 minutes before start of intake of dinner; omeprazole was administered twice daily from Days -5 to -1 or Days 5 to 9 (depending on assigned treatment period), 1 hour before breakfast and dinner, and from Days 1 to 4 or Days 10 to 13, 1 hour prior to the administration of AZD1722
16091332|NCT02226770|Device|Implantable Cardioverter Defibrillator (ICD)|
16091333|NCT02226757|Drug|Paclitaxel-trastzumab|"Trastuzumab
~Dose:
~First dose: 4 mg/kg IV
~Subsequent doses: 2 mg/kg every week IV.
~The patient must be monitored for at least 6 hours after the start of the first infusion and for at least 2 hours after the start of subsequent infusions.
~Paclitaxel
~- Dose: 60 mg/m2 IV in 30 minutes, every week, after trastuzumab"
16091334|NCT02226744|Behavioral|Focused Breathing|
16091335|NCT02226731|Device|Early Belfort-Dildy Balloon|Intrauterine tamponade with the Belfort-Dildy balloon, performed in the 15 minutes after randomization at the same time as the second line uterotonic treatment.
16091336|NCT02226731|Device|Late Belfort-Dildy balloon|Intrauterine tamponade with the Belfort-Dildy balloon, performed if failure of second line uterotonic treatment, ie persisting bleeding 30 minutes after the beginning of this infusion.
16091337|NCT02226718|Other|Administration of questionnaire|
16091338|NCT02226705|Procedure|Multiple transnasal endoscopic surgeries|Transnasal endoscopic surgery extended to the skull base
16091339|NCT02226679|Device|Algisyl-LVR|Algisyl-LVR™ device (implants) administered during a surgical procedure
16091340|NCT02226666|Drug|MRI with Multihance|Patients will have Multihance used as an IV contrast agent for their scan.
16091341|NCT02226666|Drug|MRI with Eovist|Patients will have Eovist used as an IV contrast agent for their scan.
16091342|NCT02226653|Drug|Evacetrapib|Administered orally
16091343|NCT02226614|Device|University of Edinburgh head cooling device|head cooling
16091344|NCT02226601|Drug|Aprepitant|3 days perioperative Aprepitant once a day
16091345|NCT02226601|Drug|Placebo|3 days perioperative Placebot once a day
16091346|NCT02226588|Drug|Misoprostol|
16091347|NCT02226575|Behavioral|A cognitive behavior therapy distress management program targeting wellbeing in patients with atrial fibrillation and their relatives|Controls only delivery standard care. Experimental group deliver standard care plus a distress management program (cognitive behavioral therapy) performed in groups by a nurse, a pedagogue and a cardiologist (all trained in the distress management program).
16091348|NCT02226562|Drug|Potassium nitrate and sodium fluoride|3.0% w/w potassium nitrate mouthwash with 0.02% sodium fluoride
16091349|NCT02226562|Drug|Standard fluoride dentifrice|Standard fluoride dentifrice containing 1000 ppm fluoride as SMFP
16091350|NCT02226549|Drug|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet administered orally once daily
16091351|NCT02226549|Drug|VDV|VDV 80 mg tablet administered orally once daily
16091352|NCT02226549|Drug|RBV|RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16091391|NCT02226263|Dietary Supplement|probiotics Lactobacillus acidophilus boucardii|Using sterile technique, the probiotic with 1x109 [CFU] Lactobacillus acidophilus boucardii strain was added at a dose of 125 mg/ kg/dose twice daily for 4 weeks to fresh supplement breast milk or formula for preterm infants.
16091353|NCT02226536|Behavioral|fractioned diet without glucose|Patients were divided into two groups: Diet Group was treated with placebo pills and glucose restrictive and fractionated diet. Control Group received only placebo pills. All individuals had their vestibular function evaluated by Computerized Dynamic Posturography and done visual analogue scale (VAS) in the first day and 30 days after diet intervention
16091354|NCT02226510|Drug|Metformin XL|In the active arm, the added therapy will be metformin XL in an initial dose of 1000mg/day . They will continue on Metformin XL 500mg x2/day for 2 weeks and after safety blood checks the metformin XL dose will be increased to 2000 mg/day. If the higher dose cannot be tolerated the dose will be reduced to 1000mg/day.
16091355|NCT02226510|Drug|Placebo|Placebo capsules (with an identical appearance to the active drug) containing only microcrystalline cellulose PhEur will be administered.
16091356|NCT02226497|Device|Health Telemonitoring|Use home telemonitoring device
16091357|NCT02226497|Other|Quality-of-Life Assessment|Ancillary studies
16091358|NCT02226497|Other|Questionnaire Administration|Ancillary studies
16091359|NCT02226497|Procedure|Supportive Care|Receive standard outpatient supportive care
16091360|NCT02226484|Drug|Quercetin|Two 250 mg capsules of quercetin twice-a-day one hour before meals with a glass of water.
16091361|NCT02226458|Drug|EPI-743|
16091362|NCT02226445|Other|Combined ADHD medication and psychosocial counseling|"The patients are offered as well ADHD medication as non-standardized psychosocial treatment, the latter including psychoeducation (i.e. information about ADHD aetiology and symptoms plus management of symptoms) and counselling regarding emotional-, family- and social rehabilitation-related problems.
~ADHD medication:
~First choice of medication is methylphenidate immediate release, initially 5 mg 2-3 times a day increasing with 10-20 mg per week up to stabilization of symptoms.
~When stabilized a shift to extended release methylphenidate. Alternatively dexamphetamine, initially 2.5 mg 2-3 times a day increasing with 5-10 mg per week up to stabilization of symptoms.
~If there is no adequate effect of central stimulants then a shift to atomoxetine, initially 18 mg a day, increasing during a period of 6-10 weeks up to max. 100 mg a day.
~If the patients have a substance use, an anxiety problem or other contraindications then first choice of medication is atomoxetine."
16091363|NCT02226432|Procedure|- Postoperative Antagonistic Peripheral Magnetic Stimulation|"Selected patients will be treated with Selective peripheral Neurotomy followed by an standartized cycle of Selective Peripheral Magnetic Stimulation and classic post operative Kinesic Therapy.
~Sham patients (n 10) will be treated with classic post operative Kinesic Therapy.
~Comparision of both groups will be statistified"
16091364|NCT02226432|Device|Selective Peripheral Magnetic Stimulation|"Peripheral 1.5 tesla intensity, 10 Hz of Frequency, with eight saped bovine, of 30 minutes, aplied on antagonistic muscles, twice a week. Intensity will be infrathreshold, 80 per cent of the individual threshold (minimal amount of intensity producing always a muscle motor response in each particular patient)"
16091365|NCT02226432|Other|Kinesics|Session of classic Kinetic Rehabilitation and motor exercises, twice a week on Physicians´s office and dayly on patient´s home.
16091366|NCT02226419|Dietary Supplement|Break in L-carnitine treatment|Levocarnitine oral tablet supplement at individual doses
16091367|NCT02226406|Other|A: Chair - Leg Cycle ergometer|
16091368|NCT02226406|Other|B: Chair - Arm Cycle ergometer|
16091369|NCT02226406|Other|C: Walk in place|
16091370|NCT02226393|Behavioral|Prolonged exposure|The PE treatment includes 12-15 60 minutes' sessions. The 2 main components of the treatment are psychoeducation about common reactions to trauma and in-vivo exposures (gradual exposure to trauma related situations and objects) and repeated recounting of the traumatic memory, Trauma memory recounting and in-vivo exposures are conducted during several successive sessions so the child learns that the exposures themselves pose no real harm to him, indicating that when one confronts what one is afraid of it becomes easier to manage.
16091371|NCT02226393|Behavioral|Child-parent Play Therapy|Is consisted of 12-15 weekly 60 minute sessions of parent-child centered therapy it focus on establishing a trusting, empowering, and validating therapeutic relationship. Participants are allowed to choose when, how, and whether or not to address their trauma memory. Therapists provide active listening, empathy,and encouragement to talk about feelings and express belief in the participants ability to cope. In sessions 4 and 8, participants are asked how they feel about their trauma. With this exception, participants direct the sessions.
16091372|NCT02226380|Drug|mFOLFOX6 regimen|oxaliplatin 85 mg/m2 and folinic acid 400 mg/m2 are administered intravenously for 2 hours on day 1 following by 5-FU at 2,400 mg/m2 by continuous infusion for 46hours every 2 weeks for 3 cycles before performing surgery
16091373|NCT02226367|Drug|prazosin hydrochloride|study drug arm prazosin
16091374|NCT02226367|Drug|placebo|study drug arm placebo
16091375|NCT02226354|Dietary Supplement|Ahiflower oil|9.73 ml per day for 28 days
16091376|NCT02226354|Dietary Supplement|Flaxseed oil|9.73ml per day for 28 days
16091377|NCT02226341|Drug|CellCept|"For both arms:
~CellCept 3 grams daily, oral, from Week 0-24 CellCept 2 grams daily, oral, from Week 25-144"
16091378|NCT02226341|Drug|ACTHar gel|Arm 1: 80 U biw, subcutaneous, for 3 months. Optionally additional 3 months of 80 U biw if a patient has partial response.
16091379|NCT02226341|Drug|ACTHar gel|Arm 2: 80 U qod, subcutaneous, for 1 month, then 80 U biw, subcutaneous, for 2 months. Optionally additional 3 months of 80 U biw if a patient has partial response.
16091380|NCT02226328|Drug|Propofol sedation|
16091381|NCT02226328|Drug|Midazolam and Fentanyl sedation|
16091382|NCT02226289|Drug|Bevacizumab|bevacizumab with the latest received cytotoxic regimen
16091383|NCT02226276|Radiation|fludeoxyglucose F 18|Undergo fludeoxyglucose F 18 PET/CT
16091384|NCT02226276|Procedure|positron emission tomography|Undergo fludeoxyglucose F 18 PET/CT
16091385|NCT02226276|Procedure|computed tomography|Undergo fludeoxyglucose F 18 PET/CT
16091386|NCT02226276|Biological|trastuzumab|Given IV
16091387|NCT02226276|Radiation|copper Cu 64-DOTA-trastuzumab|Given IV
16091388|NCT02226276|Procedure|positron emission tomography|Undergo copper Cu-DOTA-trastuzumab PET
16091389|NCT02226276|Biological|ado-trastuzumab emtansine|Given IV
16091390|NCT02226276|Other|laboratory biomarker analysis|Correlative studies
16091392|NCT02226250|Dietary Supplement|3 Placebo Beverages|Sugar beverage 2 hr before meal, with meal and 2 hr after meal
16091452|NCT02225756|Drug|Placebo|Oral administration for a short time of placebo
16091394|NCT02226237|Procedure|anal electrostimulation group|The anal electrical stimulation protocol was performed by a physical therapist for seven weeks, twice per week, using the apparatus Dualpex 961 Uro® Quark, with frequency of 35 Hz, and the intensity determined according to the tolerance of the patient, lasting 20 minutes.
16091395|NCT02226211|Device|Air-Q intubation laryngeal airway|"The size selection of the air-Q ILA will follow the manufacture guideline to be size 3.5 for females and size 4.5 for males After induction of general anesthesia, the devices will be inserted by using midline insertion technique, then cuff will be inflated according to manufacture recommendations.
~After successful insertion of the air-Q, the appropriate endoracheal tube (ETT) will be loaded over the fiberoptic bronchoscopy, and the connector will be removed too. The bronchoscope will be introduced and advanced throughout the airway tube to just proximal to ventilating orifice, a video image of the fiberoptic view will be recorded and saved on CD to be graded later by an independent observe. The fiberoptic then will be advanced and once the carina is seen, the ETT is will be slided into the trachea.
~After successful intubation, the device will be removed according to the manufactures guides using removal stylet ."
16091396|NCT02226211|Device|Ambu-Aura i laryngeal mask|"The size selection of the device will follow the manufacture guideline according to the patient weight, size 4 for (50-70kg), size 5 (70-100) and size 6 (> 100kg).
~After induction of general anesthesia, the devices will be inserted by using midline insertion technique, then cuff will be inflated according to manufacture recommendations.
~After successful insertion of the aura-i, the appropriate endoracheal tube (ETT) will be loaded over the fiberoptic bronchoscopy, and the connector will be removed too. The bronchoscope will be introduced and advanced throughout the airway tube to just proximal to ventilating orifice, a video image of the fiberoptic view will be recorded and saved on CD to be graded later by an independent observe. The fiberoptic then will be advanced and once the carina is seen, the ETT is will be slided into the trachea.
~After successful intubation, the device will be removed according to the manufactures guides using another ETT."
16091397|NCT02226198|Drug|Rosuvastatin 20mg|Active drug will be taken taken orally, QD, either in the morning or in the evening
16091398|NCT02226198|Drug|Placebo|Will be taken taken orally, QD, either in the morning or in the evening
16091399|NCT02226185|Drug|Berberine hydrochloride|supplement of Berberine hydrochloride 0.3g two times per day for 2-3 years
16091400|NCT02226185|Drug|placebo|supplement of placebo two times per day for 2-3 years
16091401|NCT02226172|Drug|Glasdegib (PF-04449913)|Oral daily dose of glasdegib (PF-04449913) 100 mg tablet in a continuous regimen of 28-day cycles.
16091402|NCT02226172|Drug|Placebo|Oral daily dose of placebo 100 mg tablet in a continuous regimen of 28-day cycles.
16091403|NCT02226159|Drug|Lidocaine|
16091404|NCT02226159|Drug|Lidocaine with Dexamethasone|
16091405|NCT02226146|Biological|Bertilimumab|
16091406|NCT02226133|Device|LAAx, Inc. TigerPaw® System II|Exclusion of Left Atrial Appendage.
16091407|NCT02226120|Drug|LCZ696|Angiotensin receptor antagonist neprilysin inhibitor (ARNI) with target dose of 200 mg bid
16091408|NCT02226107|Behavioral|Peer-PN|Participants in the peer-PN group will also receive two navigation telephone calls: 1) to schedule the colonoscopy, and 2) a reminder call one week before the procedure. It is expected that these phone calls will be shortly longer than the Pro-PN calls by 5-7 minutes because of the additional focus on culture and peer modeling. Peers will remind the patient about the procedure and address concerns, but will provide culturally specific, identity-based navigation, in which they will speak specifically about Latino rates of CRC screening while also modeling self-efficacy by describing what their experience was like before, during and after the colonoscopy procedure.
16091409|NCT02226107|Behavioral|Pro-PN|Participants in the standard navigation group receive two phone calls: 1) to schedule the colonoscopy and 2) a reminder call one week before the procedure. The phone calls will each last approximately 15 minutes. During the second phone call, the patient will be reminded about the procedure and any concerns they may have will be addressed. Professional navigators will also be advised to not disclose their race or ethnicity or to discuss specific issues related to Latinos and CRC screening.
16091410|NCT02226094|Device|DWT device dose A|Deep Wave Trabeculoplasty (DWT) is an investigational device intended to reduce IOP in patients with POAG or OHT. The DWT device applies focal mechanical oscillation (low amplitude, sonic frequency) to the surface of the eye proximate the limbal region and anterior to the trabecular meshwork (TM). Mechanical oscillation of the TM by the DWT device is believed to initiate a physiological cascade to restore function of the TM, increase the outflow of aqueous humor and thereby decrease the IOP. DWT involves 24 spot treatments applied around the limbal region on the ocular surface. Dose A refers to 10 second spot treatments.
16091411|NCT02226094|Device|Ellex Tango SLT machine|Laser trabeculoplasty is the application of a laser beam to burn areas of the trabecular meshwork, located near the base of the iris, to increase fluid outflow. Selective laser trabeculoplasty (SLT) uses a Nd:YAG laser to target specific cells within the trabecular meshwork and create thermal damage.
16091412|NCT02226094|Device|DWT device dose B|Same as DWT device dose A except 20 second spot treatments.
16091413|NCT02226094|Device|DWT sham|Same as DWT device dose A except device not applied to ocular surface.
16091414|NCT02226068|Drug|Cyclosporine A (CsA)|3 mg/kg/day for 4 month
16091415|NCT02226068|Other|Extracorporeal photopheresis (ECP)|Administered two consecutive days twice a month for 4 month
16091416|NCT02226055|Device|Arterial Stiffness Assessment|"The following will be measured: brachial systolic and diastolic bp, heart rate, mean arterial bp, pulse pressure, brachial augmentation index (difference between the amplitudes of the late (backward) systolic wave (P2) and the early (forward) systolic wave (P1) over the pulse pressure x 100), central augmentation, ejection duration of the left ventricle, return time (time of the pulse wave travelling from aortic root to the bifurcation and back), aortic pulse wave velocity ( velocity of the pulse wave in the aorta), central systolic bp, central pulse pressure and diastolic reflection area (provides information about the quality of diastolic filling in the coronary arteries).
~We will perform an arterial age assessment. Patients are given a feedback form with their results to give to their general. Those with increased arterial stiffness will be tested for serum calcium and phosphate levels, and audited to ensure that a statin is commenced if not contraindicated."
16091453|NCT02225743|Other|Observation Of Temperature|Participants temperature will be recorded perioperatively.
16091680|NCT02224131|Drug|Aspirin and clopidogrel|modification of aspirin and clopidogrelmaintenance doses based on a biological assay Device:thrombelastography(TEG) point of care assay TEG(Haemoscope Corporation, Niles, IL)
16091417|NCT02226042|Behavioral|Mindfulness-based Cognitive Therapy|MBCT: Mindfulness-based Cognitive Therapy is an 8 week group-based programme consisting of approximately 12 participants per group. There is also a full one day of practice around week 6. MBCT was initially designed for individuals in remission from depression and at risk of relapsing. The intervention is a mix of mindfulness meditation, cognitive behavioural therapy exercises and psychoeducation. MBCT has been shown to be effective in reducing relapse risk over 12 months.
16091418|NCT02226029|Other|Lipid emulsion|"2 isovolumetric (200 ml) and isocaloric (200 kcal) lipid emulsions with different acid and shear stability
~Lipid emulsion 1: acid stable, particle size 0.6 µm
~Lipid emulsion 2: acid unstable, redispersible by mechanical processes during antral contractions and passage through the pylorus, particle size 0.6 µm
~13C-markers will be mixed with emulsions"
16091419|NCT02226016|Device|FG-5000A|a measuring device for the assessment of levator muscle strength
16091420|NCT02226003|Drug|Ertugliflozin|Ertugliflozin, 5 mg or 15 mg, administered orally, once daily for 26 weeks.
16091421|NCT02226003|Drug|Sitagliptin|Sitagliptin, 100 mg, administered orally, once daily for 26 weeks.
16091422|NCT02226003|Drug|Placebo to Ertugliflozin|Matching placebo to ertugliflozin administered orally, once daily for 26 weeks.
16091423|NCT02226003|Drug|Placebo to Sitagliptin|Matching placebo to sitagliptin administered orally, once daily for 26 weeks.
16091424|NCT02226003|Drug|Glimepiride|Open-label glimepiride rescue therapy will be initiated at 1 or 2 mg/day and may be titrated to the maximum labeled dose or maximum tolerated dose (if lower than labeled dose), as considered appropriate by the investigator, based on blood glucose measurements and in accordance with the local, approved label.
16091425|NCT02225990|Other|Experimental Group, Sub-Acute|For the sub-acute experimental group, the intervention schedule will be as follows: six months of individual therapy five times weekly (1 - 2.5 hours/session); 6 months of 'refresher' individual therapy twice monthly (1 - 2.5 hours/session) + group therapy up to three times weekly (1 hour/session); and 1 year of group therapy, up to three times weekly (1 hour/session) + 1 'refresher' individual therapy session every 3 months for a total study duration of 2 years.
16091426|NCT02225990|Other|Experimental Group, Chronic|For the chronic experimental group, the intervention schedule will be as follows: six months of individual therapy five times weekly (1 - 2.5 hours/session); 6 months of 'refresher' individual therapy twice monthly (1 - 2.5 hours/session) + group therapy up to three times weekly (1 hour/session); and 1 year of group therapy, up to three times weekly (1 hour/session) + 1 'refresher' individual therapy session every 3 months for a total study duration of 2 years.
16091427|NCT02225990|Other|Standard of Care, Sub-Acute|This group will receive standard of care stroke rehabilitation therapy.
16091428|NCT02225990|Other|Standard of Care, Chronic|This group will receive standard of care stroke rehabilitation therapy.
16091429|NCT02225977|Drug|Gilenya|
16091430|NCT02225951|Dietary Supplement|Nutritional product|
16091431|NCT02225951|Other|Standard breakfast according to ADA recommendations|
16091432|NCT02225925|Radiation|Brachytherapy|
16091433|NCT02225912|Other|PrevinC|
16091434|NCT02225912|Drug|placebo|
16091435|NCT02225886|Drug|Ascorbic Acid|300 mg of intravenous ascorbic acid will be given 3 times a week, postdialysis, in 100 mL saline solution, except for the dialysis sessions when iv iron is administered
16091436|NCT02225873|Other|motor control exercises|Will carry out intermuscular coordination exercises through cranio-cervical training, following Jull et al. and exercises to increase strength-endurance on the neck flexor muscles
16091437|NCT02225873|Other|muscle strength-endurance and proprioception|Will carry out proprioception exercises through articular repositioning training and exercises to increase strength-endurance on the neck flexor muscles. They will be performed in the same way as the experimental group protocol.
16091438|NCT02225860|Behavioral|Diet and water adjustment|The dietary intervention consisted of three elements: low sodium (1500 mg/day), low protein (daily protein dietary allowance of 0.8 gram/kg body weight), and low urea (avoidance of preservatives, food additives, bulking agents, and chewing gum). Protein was factored by measured body weight to mirror the estimated average requirement (EAR) of healthy adults which is set on a grams per kilogram basis
16091439|NCT02225847|Other|Gardening|The intervention consists of twice weekly group sessions of gardening activities of 60 minutes in duration that will take place in a greenhouse. A total of 12 gardening sessions administered over a period of six weeks will include planting seeds, bulbs and tubers, transplanting seedlings, vegetative propagation and sight, smell, taste and touch sensory based activities.
16091440|NCT02225847|Procedure|Functional Magnetic Resonance Imaging (fMRI)|Functional magnetic resonance imaging will be employed to assess whether engaging in gardening activities in a greenhouse does or does not alter the spatial patterns of brain network activation relative to changes that occur between the groups.
16091441|NCT02225847|Behavioral|psychometric assessments|The following assessments will be used: The SF-36 Health Survey assessment instrument (Ware and Sherbourne 1992; Hays et al 1993), the Beck Depression Inventory 2nd edition (BDI-II) (Beck et al 1988), The State Trait Anxiety Inventory (STAI) instrument (Form Y) (Spielberger et al 1983), the Profile of Mood States 2nd edition short form for adults instrument (POMS2-AS), and the Perceived Stress Scale (PSS) (Cohen et al 1983) for changes that occur in between the groups.
16091442|NCT02225834|Drug|Atorvastatin|treatment with atorvastatin 80 mg (once-daily) from admission day until discharge
16091443|NCT02225821|Drug|Cephalozin|1000 mg Cephalozin
16091444|NCT02225821|Other|Sodium chloride|10 cc of NaCl 0.9%
16091445|NCT02225808|Behavioral|CBT for anxiety in autism|
16091446|NCT02225795|Other|Hematopoietic stem cell transplantation|"Immuno-ablative regimen for HSCT:
~Day Treatment
~6 r-ATG 2 mg/kg
~5 r-ATG3 2 mg/kg
~4 r-ATG3 2 mg/kg
~3 Cyclophosphamide with Mesna
~2 Cyclophosphamide with Mesna
~1 REST 0 PBSC infusion
~3 Cyclophosphamide with Mesna
~4 Cyclophosphamide with Mesna
~6 Start GCSF"
16091447|NCT02225782|Drug|Alteplase|Alteplase is a fibrinolytic drug widely used to restore hemodialysis catheter patency.
16091448|NCT02225769|Other|Management of febrile children using e-POCT|Use of the e-POCT tool by study clinicians for the clinical management of febrile episodes. The e-POCT tool is an electronic algorithm that integrates key clinical elements with the results of malaria and host biomarkers point-of-care test results (including oximetry).
16091449|NCT02225769|Other|Management of febrile children using ALMANACH|Management of febrile children by study clinicians using ALMANACH. ALMANACH is an improved IMCI algorithm on mobile phone or tablet
16091454|NCT02225717|Procedure|Cervicovaginal swab|Sample of cervicovaginal secretions made by the surgical team using a sterile swab introduced directly into the posterior fornix of vagina for one minute during the insertion of the urinary catheter
16091455|NCT02225704|Drug|Radium-223 and enzalutamide|
16091456|NCT02225691|Device|Paired testing of blood glucose Accu-Chek®|Patients in the paired testing arms will undergo training on paired testing with Accu-Chek® Active blood glucose meters. The paired testing training would include (1) how and when (testing regimen) to perform paired testing, and (2) how to respond to paired testing readings via lifestyle modifications, self-adjustment of insulin dose and additional testing, if applicable. Please refer to Annex A for further details of the training.
16091457|NCT02225665|Genetic|SB-728mR-T|-SB-728mR-T infusions of 2 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)
16091458|NCT02225665|Genetic|SB-728mR-T|- SB-728mR-T infusions of 3 equal doses 14 days apart (total of up to 40 billion ZFN modified T-cells)
16091459|NCT02225665|Drug|Cyclophosphamide|- IV cyclophosphamide 1 g/m2 two days prior to the first SB-728mR-T infusion
16091460|NCT02225652|Drug|FEC (Fluorouracil, Epirubicin, Cyclophosphamide) + filgrastim + paclitaxel|
16091461|NCT02225639|Drug|PRC-063 25 mg|Oral 25 mg capsule - active
16091462|NCT02225639|Drug|Placebo|Oral placebo capsule
16091463|NCT02225639|Drug|PRC-063 35 mg|Oral 35 mg capsule - active
16091464|NCT02225639|Drug|PRC-063 45 mg|Oral 45 mg capsule - active
16091465|NCT02225639|Drug|PRC-063 55 mg|Oral 55 mg capsule - active
16091466|NCT02225639|Drug|PRC-063 70 mg|Oral 70 mg capsule - active
16091467|NCT02225639|Drug|PRC-063 85 mg|Oral 85 mg capsule - active
16091468|NCT02225639|Drug|PRC-063 100 mg|Oral 100 mg capsule - active
16091469|NCT02225626|Drug|BI 1060469|tablet, oral administration with 240 mL of water after an overnight fast of at least 10 h
16091470|NCT02225626|Drug|BI 1060469|tablet, oral administration with 240 mL water 30 minutes after subject is served a standardised high-caloric high-fat administration
16091471|NCT02225626|Drug|Other: standard breakfast|tablet, oral administration with 240 mL water 30 minutes after subject is served a standardised high-caloric high-fat administration
16091472|NCT02225613|Other|Usual protocol|
16091473|NCT02225613|Other|Spa protocol|
16091474|NCT02225600|Drug|40 IU Intranasal Oxytocin|40 IU intranasal oxytocin
16091475|NCT02225600|Drug|Placebo|Intranasal Placebo
16091476|NCT02225600|Drug|24 IU intranasal Oxytocin|
16091477|NCT02225587|Biological|Prevnar 13™|Pneumococcal vaccine containing serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F. Injections are to be administered into the deltoid muscle of the upper arm.
16091478|NCT02225587|Biological|Pneumovax™ 23|Pneumococcal vaccine containing serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, and 33F. Injections are to be administered into the deltoid muscle of the upper arm.
16091479|NCT02225587|Biological|Placebo|Injections are to be administered into the deltoid muscle of the upper arm.
16091480|NCT02225574|Drug|MEK-162|"Phase 1: Advanced CML + Philadelphia positive Acute Leukemia-Group 1 Starting Dose of MEK-162: 30 mg by mouth twice a day on starting on Day 1 of a 28 day cycle.
~Phase 2 Advanced CML + Philadelphia positive Acute Leukemia-Group 1 Starting dose of MEK-162: MTD from Phase 1 to be taken by mouth twice a day starting on on Day 1 of a 28 day cycle.
~Phase 1 Chronic Phase CML - Group 2 Starting dose of MEK-162: 30 mg by mouth twice a day of a 28 day cycle.
~Phase 2 Chronic Phase CML - Group 2 Starting Dose of MEK-162: MTD from Phase 1 by mouth twice a day starting on Day 8 of a 28 day cycle."
16091481|NCT02225574|Drug|Nilotinib|"Phase 1 Advanced CML + Philadelphia positive Acute Leukemia-Group 1 Starting Dose of Nilotinib: 400 mg by mouth twice a day of a 28 day cycle.
~Phase 2 Advanced CML + Philadelphia positive Acute Leukemia-Group 1 Starting dose of Nilotinib: MTD from Phase 1 to be taken by mouth twice a day starting on Day 2 of a 28 day cycle.
~Phase 1 Chronic Phase CML - Group 2 Starting dose of Nilotinib: 400 mg by mouth twice a day of a 28 day cycle.
~Phase 2 Chronic Phase CML - Group 2 Starting Dose of Nilotinib: MTD from Phase 1 by mouth twice a day starting on Day 1 of a 28 day cycle."
16091482|NCT02225574|Behavioral|Questionnaires|Questionnaires completed and the end of cycle 1, 2, 3, 6, 9, and 12.
16091483|NCT02225561|Procedure|pharmaco- mechanical optimization|"Getting started as soon as possible cardiopulmonary resuscitation (CPR) mechanical ( LUCAS 2) with inspiratory impedance valve ( ResQPOD ) performed according to the 2015 recommendations of the European Resuscitation Council . It will be carried out continuously without a break for control pulse until the first defibrillation attempt.
~As soon the peripheral intravenous or intraosseous line is set the intervention group will receive an injection of 2 mg of sodium nitroprusside. 4 minutes after the first injection, a second and last injection of 1 mg of sodium nitroprusside will be realized.- The preparation procedure of the sodium nitroprusside will be:
~Using a pomping needle and the provided syringe 4 ml of the solvent (Water for Injections, WFI) will be take.
~The 4 ml of WFI will be empty in the 50 mg vial of lyophilisate sodium nitroprusside to solubilize the product.
~Always with the needle and 20 ml syringe, the 4 ml of this solution (50 mg in 4 ml) will be collect."
16091484|NCT02225561|Procedure|mechanical optimization only|Getting started as soon as possible cardiopulmonary resuscitation (CPR) mechanical ( LUCAS 2) with inspiratory impedance valve ( ResQPOD ) performed according to the 2015 recommendations of the European Resuscitation Council . It will be carried out continuously without a break for control pulse until the first defibrillation attempt.
16091485|NCT02225548|Drug|Selegiline|
16091486|NCT02225548|Drug|Tadalafil|
16091487|NCT02225535|Other|NP face to face management of Chronic Low Back Pain|usual NP management of chronic low back disorder
16091488|NCT02225535|Other|PT face to face management of Chronic Low Back Pain|Includes manual therapy, education, exercise
16091489|NCT02225535|Other|Interprofessional Videoconferencing for Chronic Low Back Pain|Includes manual therapy, education, exercise.
16091490|NCT02225522|Other|Rapid whole genome sequencing (StatSeq)|Patients in this arm will received standard genetic testing, the Perkins Elmer StepOne expanded newborn screen and the rapid whole genome sequencing (StatSeq). the receipt of the StatSeq testing is the different factor between arms. the standard genetic testing includes any testing that is clinically available to the attending physician that would normally be ordered for the patient if not enrolled in this study.
16091681|NCT02224131|Drug|Aspirin and clopidogrel|aspirin and clopidogrel maintenance doses (according to international guidelines)
16091491|NCT02225509|Procedure|FNA biopsy for thyroid nodule(s)|"The study is intended for patients for whom a FNA biopsy of thyroid nodule/nodules is medically indicated for the detection of thyroid cancer. FNA biopsy should preferably be carried out under ultrasound guidance. The FNA samples will be collected either from the remaining material of FNA or there will be dedicated FNA sample in order to ensure an adequate quantity of material for molecular analysis. The patients will also be invited to take part in the mutation study in a separate consent form.
~The samples of enrolled patients will be sent to the Diaxonhit Genomics Laboratory and analysed using Diaxonhit technology after checking the quantity and quality of the samples. Enrolled patients whose samples are inadequate in terms of quantity or quality for the various molecular tests will not be considered for the study. If necessary, mutation analyses can be carried out anonymously by an independent French laboratory and under the supervision of Diaxonhit."
16091492|NCT02225496|Procedure|Transoral Robotic Surgery (TORS)|Transoral robotic surgery performed utilizing Intuitive Surgical da Vinci Surgical System. Utilizing robotic surgical system, tumor excised with wide surgical margins of 0.5-1 cm.
16091493|NCT02225496|Procedure|Modified Barium Swallow (MBS)|MBS performed at baseline and 1 - 4 weeks after surgery, and at 6 months, 12 months and 24 months.
16091494|NCT02225496|Behavioral|Questionnaires|Questionnaires about speech and swallowing function completed at baseline, 1 - 4 weeks after surgery, and at 6 months, 12 months, and at 24 months.
16091495|NCT02225470|Drug|E7389 (Eribulin Mesylate)|
16091496|NCT02225470|Drug|Vinorelbine injection|
16091497|NCT02225457|Other|Hypercaloric diet|"Hypercaloric diet will be designed to provide 50% excess in calories compared to daily requirements. It will consist in a snack type, high fat and high carbohydrates diet."
16091498|NCT02225457|Dietary Supplement|polyphenols|Administration of polyphenols will consist in the administration of 1 gram (5x200 mg) of the compound bid during the entire overfeeding period.
16091499|NCT02225457|Dietary Supplement|placebo (for polyphenols)|Placebo will consist in the administration of a number of placebo pills matching that of polyphenols, in a similar way (bid) for the duration of the overfeeding experiment.
16091500|NCT02225444|Other|OsteoAMP|OsteoAMP in posterolateral fusion procedure of the lumbosacral spine
16091501|NCT02225431|Drug|sodium chloride infusion|
16091502|NCT02225418|Drug|Ropivacaine|
16091503|NCT02225418|Drug|saline|
16091504|NCT02225405|Drug|Cisplatin|Given IV
16091505|NCT02225405|Drug|Docetaxel|Given IV
16091506|NCT02225405|Other|Laboratory Biomarker Analysis|Correlative studies
16091507|NCT02225405|Drug|Nintedanib|Given PO
16091508|NCT02225392|Procedure|Bronchial thermoplasty|Bronchial thermoplasty (BT) will be performed using the Alair system (Boston Scientific, USA). Patients will undergo 3 bronchoscopy procedures with BT at least 3 weeks apart. Treatment sessions are designed to address different lobes of the lung with the right lower lobe treated during the first bronchoscopy, the left lower lobe treated during the second bronchoscopy, and both the right and left upper lobes treated in the third and final bronchoscopy. The right middle lobe and proximal airways including RC2 are left untreated.
16091509|NCT02225392|Device|Alair system (Boston Scientific, USA)|The alair system consist of a controller and a bastket catheter.
16091510|NCT02225379|Device|Hypo-Sense (non invasive sensor)|Parallel measurements of capillary blood glucose using reference methods (both capillary glucometer and continuous sensor) and data generated by the non- invasive study device during approximately 4 hours, in which a hypoglycemic event will be induced.
16091511|NCT02225366|Biological|LL37|Starting dose 250 µg/tumor. The injections will be given every 7 days for up to 8 weeks.
16091512|NCT02225366|Other|Photographs|Tumors measured and photographed one week before receiving LL37, and again at 4 weeks after LL37. Then photographs of the LL37 injected sites taken at 8 weeks.
16091513|NCT02225353|Drug|Progesterone Cervical Pessary 6.3 g|Progesterone Cervical Pessary low dose
16091514|NCT02225353|Drug|Progesterone 200 mg vaginal capsules|Progesterone 200 mg vaginal capsules daily
16091515|NCT02225353|Drug|Progesterone Cervical Pessary 7.7 g|Progesterone Cervical Pessary high dose
16091516|NCT02225327|Biological|Fluad alone|Fluad
16091517|NCT02225327|Biological|Fluad and PPV23 on the different arms|Fluad and Prodiax
16091518|NCT02225327|Biological|Fluad and PPV23 on the same arm|Fluad and Prodiax
16091519|NCT02225327|Biological|PPV23 alone|Prodiax
16091520|NCT02225314|Behavioral|Brain Fitness|Brain Fitness is a computer-based cognitive training programs that consists of six types of exercises that train auditory processing speed and accuracy.
16091521|NCT02225314|Behavioral|InSight|InSight is a computer-based cognitive training program that consists of five types of exercises that train visual processing and working memory.
16091522|NCT02225314|Behavioral|Active Control|The Active Control arm is a computerized learning program that consists of five programs (i.e., Wright Brothers, History of Britain, Sister Wendy's American Collection, In Search of Shakespeare, and View the Cosmos) designed to improve knowledge about literature, art, and history.
16091523|NCT02225301|Other|iLook Out for Child Abuse|The online learning module is an interactive, multi-media, self-paced intervention.
16091524|NCT02225288|Drug|E2022|transdermal E2022 tape formulation (8.1 cm x 8.1 cm)
16091525|NCT02225275|Drug|Lenalidomide|Given PO
16091526|NCT02225275|Biological|Obinutuzumab|Given IV
16091527|NCT02225262|Radiation|CyberKnife Radiosurgery|36.25 Gy delivered in 5 fractions of 7.25 Gy per fraction
16091528|NCT02225236|Behavioral|Classroom Intervention|
16091529|NCT02225223|Device|STAR™ Tumor Ablation System|Targeted-radiofrequency ablation (t-RFA)
16091530|NCT02225223|Device|StabiliT® Vertebral Augmentation System|Radiofrequency-targeted vertebral augmentation (RF-TVA)
16091531|NCT02225210|Drug|Dexmedetomidine|Loading dose:0.4μg.kg-1 Maintenance dose :0.2~0.7µg.kg-1 Sedation-Agitation Scale: maintain between 3 and 4.
16091532|NCT02225210|Drug|Midazolam|Loading dose of midazolam:0.1mg.kg-1 . Maintenance dose of midazolam :0.05~0.1mg.kg-1.h-1 . Sedation-Agitation Scale: maintain between 3 and 4
16091533|NCT02225210|Drug|Fentanyl|Loading dose of fentanyl:1 μg.kg-1 . Maintenance dose of fentanyl: 0.5~1μg.kg-1.h-1 . Sedation-Agitation Scale: maintain between 3 and 4
16091534|NCT02225197|Radiation|CyberKnife Radiosurgery|25 Gy delivered in 5 fractions of 5 Gy per fraction
16091954|NCT02222142|Drug|Isoflurane|Comparison between isoflurane and propofol, Retrospective study
16091535|NCT02225132|Drug|Hydroxyurea|"The precise mechanism by which hydroxyurea produces its cytotoxic and cytoreductive effects is not known. However, various studies support the hypothesis that hydroxyurea causes an immediate inhibition of DNA synthesis by acting as a ribonucleotide reductase inhibitor, without interfering with the synthesis of ribonucleic acid or of protein.
~The mechanisms by which DROXIA produces its beneficial effects in patients with sickle cell anemia (SCA) are uncertain. Known pharmacologic effects of DROXIA that may contribute to its beneficial effects include increasing hemoglobin F levels in RBCs, decreasing neutrophils, increasing the water content of RBCs, increasing deformability of sickled cells, and altering the adhesion of RBCs to endothelium."
16091536|NCT02225106|Drug|Methylphenidate|Subjects will be treated with oral methylphenidate, using a forced titration up to a dose of 30 mg given twice daily for 4 weeks. At that point, the neuropsychologic tests are repeated.
16091537|NCT02225093|Drug|Caffeine|Oral
16091538|NCT02225093|Drug|Dextromethorphan|Oral /.L
16091539|NCT02225093|Drug|Enzalutamide|Oral
16091540|NCT02225093|Drug|Enzalutamide Placebo to Match (PTM)|Oral
16091541|NCT02225067|Drug|Calcium (13C)Carbonate|Visit 1 and Visit 2, 24-hour gastric pH monitoring and C13-CAC breath test containing 200 mg of Calcium (13C)Carbonate
16091542|NCT02225054|Drug|Dexmedetomidine|0.5 u/kg Dexmedetomidine diluted in saline to 1 mL (single interscalene injection) Dexmedetomidine 0.5 u/kg as a single IV bolus over 30 minutes following GA induction
16091543|NCT02225054|Drug|Ropivacaine|15 ml 0.5%
16091544|NCT02225054|Drug|Normal Saline|1 mL 0.9%
16091545|NCT02225028|Behavioral|Physical Activity Counseling|Participants in the physical activity counseling group will be mailed a home exercise toolkit that may include an activity monitor, exercise resistance bands, and exercise DVDs made for people with paraplegia or tetraplegia.
16091546|NCT02225015|Behavioral|Follow-up Telephone Genetic Counselling|Individualized theoretical genetic counselling among women with BRCA mutations to assess the impact it has on the uptake of cancer prevention strategies.
16091547|NCT02225002|Drug|CP-870,893|
16091548|NCT02224989|Behavioral|Mind-Body Bridging|An awareness training program. One 2 hr class per week for 10 weeks.
16091549|NCT02224976|Behavioral|Intensified Training|Volunteers will increase exercise training by 30% from baseline
16091550|NCT02224963|Behavioral|Preventive Problem-Solving Training|Preventive Problem-solving Training is an adaptation of Problem-Solving Therapy that builds problem-solving skills and then focuses these skills on potential future problems. It aims to reduce avoidance of contemplation of future needs and enhance gathering information, decision-making, and concrete planning about future needs.
16091551|NCT02224963|Behavioral|Life and Health Review|Life and Health Review is an Enhanced Attention Control that provides classes and resource information modules, just as in intervention. It differs from the intervention in that we conduct an 8-session life and health review with subjects, in which they recount life experiences from childhood to the present.
16091552|NCT02224950|Device|Non-medicated Emollient plus Lyocell/Chitosan Sleeve|
16091553|NCT02224950|Other|Non-medicated Emollient plus Cotton Sleeve|
16091554|NCT02224950|Other|Placebo Sleeve|
16091555|NCT02224937|Drug|Melatonin|
16091556|NCT02224937|Drug|Placebo|
16091557|NCT02224924|Other|ABPI|If the patient was assigned to the ABPI group, a blood patch will be administered using the clotted blood in the syringe obtained at the beginning of the procedure. The guiding needle will be retracted up to 1.5-2 cm from the pleural surface, and the blood will be injected steadily and gently as the needle is pulled back out of the pleura. Injection will stop when the operator feels the needle is in subcutaneous tissues.
16091558|NCT02224924|Device|BioSentry (formerly known as Bio-Seal) hydrogel Tract Plug|If the patient is assigned to BioSentry group, using the manufacturer's deployment device the introducer needle is positioned so that the tip is at least 1.5 cm deep to the visceral pleura. The coaxial introducer needle hub will be prehydrated with a drop of saline, the BioSentry plug housing will be mated and locked to the hub and the plug will be deployed.
16091559|NCT02224911|Device|Laser Interstitial Thermal Therapy|
16091560|NCT02224898|Behavioral|Mobile Mindfulness Therapy|Subjects will be asked to complete 30 days of mobile mindfulness therapy, for 2-30 minutes daily.
16091561|NCT02224885|Device|CT-guided percutaneous biopsy or ablation|Standard interventional radiology procedure for a biopsy or ablation in the liver or in the lung
16091562|NCT02224872|Procedure|Bone marrow transplant|Day 0
16091563|NCT02224872|Drug|Thymoglobulin|0.5 mg/kg IV on Day -9 2 mg/kg IV on Days -8, -7
16091564|NCT02224872|Drug|Fludarabine|30 mg/M2 IV on days -6 to -2
16091565|NCT02224872|Drug|Cyclophosphamide|14.5 mg/kg IV on days -6, -5, 3, 4
16091566|NCT02224872|Radiation|TBI|200 cGy on day -1
16091567|NCT02224872|Drug|Mesna|40 mg/kg IV on days 3, 4
16091568|NCT02224872|Drug|Tacrolimus|For patients 18 years or older, tacrolimus will be given per institutional standards; may be increased or later changed to a PO BID schedule. Treatment to continue until Day 365 or longer if GVHD present
16091569|NCT02224872|Drug|Mycophenolic acid mofetil|15 mg/kg PO/IV TID beginning on day 5 through day 35
16091570|NCT02224859|Device|HCP will place the Invictus Cranial Support Device (CSD) on the patient|"There is no active therapeutic treatment (e.g., medication, stimulation, etc.) associated with this device or study. All supplies for this study will be supplied by the sponsor and returned to them upon completion of the trial.
~The device used in this study is a soft gel based bonnet referred to as a Cranial Support Device (CSD). In this study, after obtaining written informed consent from the patient's parent(s) or guardian(s) and confirming that the patient meets all inclusion and no exclusion criteria, the study HCP will place the CSD on the selected patient."
16091571|NCT02224859|Other|human intervention|This study is designed to evaluate the safety of the Invictus Cranial Support Device (CSD) when worn by medically stable infants within a neonatal intensive care unit (NICU), to evaluate the form, fit, and ease of use/application of the CSD device (i.e., utility), as well as initial impressions of safety, by health care providers (HCPs) after placing the current CSD on infants for approximately six (6) hours in a NICU
16091572|NCT02224846|Drug|Tadalafil|Administered orally
16091618|NCT02224560|Drug|Placebo control|Placebo was presented as an oral solution containing 0 mg/mL CBD in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL).
16091955|NCT02222129|Drug|Bupivacaine|
16091573|NCT02224833|Behavioral|Pharmacist intervention|"Systematic review of treatments:
~Identification of reasons for PPI.
~Determination of recommended pharmacotherapeutic alternatives.
~Issue recommendations for therapeutic appropriateness to the doctor (via registration on the EHR and verbal communication if deemed appropriate); that will be of 4 types: Add medicine, discontinue medicine, adjust dosage, replace medicine.
~After the medical visit (the next day) New treatment review for: Checking acceptance or rejection of the recommendations issued, review potential new prescriptions made without pharmacist recommending, and whether these new drugs lead to PIP."
16091574|NCT02224820|Biological|IdeS|Doses are administered in ascending doses
16091575|NCT02224807|Behavioral|Active Comparator: Progressive Resistance Training (PRT) and a healthy diet|no additional information; see arm description
16091576|NCT02224807|Behavioral|Experimental: PRT and a healthy diet, plus weight loss|no additional information, see arm description
16091577|NCT02224794|Device|Ovation® Abdominal Stent Graft Platform|
16091578|NCT02224781|Drug|Dabrafenib Mesylate|Given PO
16091579|NCT02224781|Biological|Ipilimumab|Given IV
16091580|NCT02224781|Biological|Nivolumab|Given IV
16091581|NCT02224781|Other|Quality-of-Life Assessment|Ancillary studies
16091582|NCT02224781|Drug|Trametinib Dimethyl Sulfoxide|Given PO
16091583|NCT02224768|Drug|Ipilimumab|
16091584|NCT02224755|Device|HeartMate 3 LVAS|Implantation of HeartMate 3 LVAD to evaluate the safety and effectiveness of the HeartMate 3 LVAS by demonstrating non-inferiority to the HMII LVAS (HMII) when used for the treatment of advanced, refractory, left ventricular heart failure
16091585|NCT02224755|Device|HeartMate II LVAS|Implantation of the commercially approved HeartMate II LVAD which is the standard treatment for advanced heart failure
16091586|NCT02224742|Device|LeucoPatch|LeucoPatch® is prepared by centrifuging one or more 18mL aliquots of the participant's venous blood in the LeucoPatch device and bench-top centrifuge. The centrifugation yields a tough layer of fibrin, with viable white cells and platelets, and this is applied directly to the wound surface using sterile forceps. The wound is then covered with an inert primary dressing, secondary protective dressing and the ulcerated area protected with appropriate off-loading. The patch is prepared and applied each week for up to 20 weeks or until the wound is judged healed.
16091587|NCT02224742|Other|Usual care|"Usual wound care provided in a multidisciplinary foot care clinic , in accordance with international guidelines.
~Components of usual wound care include:
~Formal assessment of ulcer and surrounding skin
~Provision of any necessary off-loading
~Debridement (i) sharp, (ii) other as appropriate (but excluding the use of larvae)
~Appropriate dressing products
~Appropriate antibiotic therapy
~Nutrition and self care
~Optimal glycaemic control
~Revascularisation if deemed clinically necessary
~Continued close observation"
16091588|NCT02224729|Drug|Bendamustine hydrochloride|Given IV
16091589|NCT02224729|Drug|Bortezomib|Given SC
16091590|NCT02224729|Drug|Dexamethasone|Given PO
16091591|NCT02224703|Drug|GWP42003-P|
16091592|NCT02224703|Drug|Placebo Control|
16091593|NCT02224690|Drug|GWP42003-P 20 mg/kg/day Dose|GWP42003-P was presented as an oral solution containing 100 mg/milliliter (mL) cannabidiol (CBD) in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL).
16091594|NCT02224690|Drug|Placebo|Placebo was presented as an oral solution containing 0 mg/mL CBD in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL).
16091595|NCT02224664|Drug|PF-06649751|Oral daily doses titrated up to 5mg QD
16091596|NCT02224664|Drug|PF-06649751|Oral daily doses titrated up to 15 mg QD
16091597|NCT02224664|Drug|PF-06649751|Oral daily doses titrated up to 15 mg QD (slow titration with option to down titrate)
16091598|NCT02224664|Drug|PF-06649751|Oral daily doses titrated up to 25 mg QD
16091599|NCT02224651|Drug|PF-06650833|Subjects will receive sequential single escalating doses of 1-1000 mg of Immediate Release of PF-06650833 (as solution/suspension) under fed and / or fasted conditions.
16091600|NCT02224651|Drug|Placebo|Subjects will receive sequential single escalating doses of PF-06650833 matching placebo (as solution/suspension) under fed and/ or fasted conditions.
16091601|NCT02224651|Drug|PF-06650833|Subjects will receive sequential single escalating doses of 10-500 mg of Modified Release of PF-06650833 (as capsule) under fed and / or fasted conditions.
16091602|NCT02224651|Drug|Placebo|Subjects will receive sequential single escalating doses of PF-06650833 matching placebo (as capsule) under fed and/ or fasted conditions.
16091603|NCT02224638|Device|TheraHoney HD|Honey
16091604|NCT02224638|Device|SkinTegrity|Hydrogel
16091605|NCT02224625|Drug|2% CHG Cloth solution|Investigational CHG
16091606|NCT02224625|Device|Vehicle Cloth|Excipients from CHG cloth only
16091607|NCT02224625|Drug|Active Comparator|Active comparator
16091608|NCT02224625|Other|Saline|Negative control
16091609|NCT02224625|Other|SLS|Provides a slight irritation for a positive control
16091610|NCT02224612|Device|Medline Pediatric Face Masks|Medline Face Masks, which are single use disposable masks were evaluated on children. The mask was worn for 2-3 minutes for EtCO2 and respiration assessments and physical fit assessment.
16091611|NCT02224612|Device|KC Childs Mask|KC Childs Mask, which are single use disposable masks were evaluated on children. The mask was worn for 2-3 minutes for EtCO2 and respiration assessments and physical fit assessment.
16091612|NCT02224599|Biological|TAPA-pulsed DC vaccine|Subjects will given the vaccine which contains 1 x 10^7 TAPA-pulsed dendritic cells and is administered ID. A total of three (3) cycles therapy will be administered weekly.
16091613|NCT02224599|Drug|Cyclophosphamide Pill|Subjects will be given low-dose cyclophosphamide by mouth for 5 days starting 5 to 7 days prior to the vaccine cycle.
16091614|NCT02224599|Drug|Imiquimod Topical Cream|Topical Imiquimod Cream will be applied after vaccination.
16091615|NCT02224586|Device|light treatment|clinical routine treatment according to the doctor's advice
16091616|NCT02224573|Drug|GWP42003-P|
16091617|NCT02224560|Drug|GWP42003-P|GWP42003-P was presented as an oral solution containing 100 mg/milliliter (mL) cannabidiol (CBD) in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL). Participants were randomly assigned to receive either 10 or 20 mg/kg/day.
16091619|NCT02224547|Radiation|Radiotherapy (Fractionated stereotactic body radiation)|Radiation: Fractionated stereotactic body radiation therapy For centrally located T1 and T2 lesions 4 x 12 Gy over 2 weeks will be delivered. Lesions located peripherally will be treated with 3 x 17Gy, also delivered within 2 weeks. For both schedules, there should be a minimum of 40 hours and a maximum of 8 days between 2 separate fractions. There should be a maximum of 2 fractions per week.
16091620|NCT02224534|Drug|Ticagrelor|Ticagrelor 180 mg as a loading dose and 90 mg twice daily as a maintenance dose
16091621|NCT02224534|Drug|Clopidogrel|Clopidogrel 600 mg as a loading dose and 75 mg once daily as a maintenance dose.
16091622|NCT02224521|Drug|GSK2190915 Solution.|Aqueous Solution, 10mg/mL.
16091623|NCT02224521|Drug|GSK2190915 Granule Capsule (A)|GSK2190915A granule filled in to Gelatin capsules
16091624|NCT02224521|Drug|GSK2190915 Semi-solid Lipid Capsule (B)|GSK2190915A dispersed in a lipid vehicle and filled in to HPMC capsules
16091625|NCT02224521|Drug|GSK2190915 Liquid Lipid Capsule (C)|GSK2190915A dissolved in lipid vehicle milled and filled in to Gelatin capsules
16091626|NCT02224521|Drug|GSK2190915 Milled Tablet|GSK2190915A granule is blended, compressed into tablets and aqueous film coated
16091627|NCT02224521|Drug|GSK2190915 Micronised Tablet|GSK2190915A granule is blended, compressed into tablets and aqueous film coated
16091628|NCT02224495|Behavioral|Structured exercise training|
16091629|NCT02224482|Behavioral|PROGRESS|PROGRESS is a multimedia website designed to help prostate cancer survivors.
16091630|NCT02224469|Device|ECoG (electrocorticography) sensing|Implant electrodes and sensing device and use for control of Assistive Technology
16091631|NCT02224456|Drug|Tenofovir disoproxil fumarate|"White, almond-shaped, film-coated tablet containing 300 mg of TDF, debossed with GILEAD and 4331 on one side of the tablet."
16091632|NCT02224443|Drug|dexmedetomidine|Experimental: Group A, Continuous pump infusion dexmedetomidine with loading dose at 0.8µg.kg-1 over 10 minutes,followed continuous pump infusion dexmedetomidine at 0.3µg.kg-1.h-1 until 30 minutes before end of operation
16091633|NCT02224443|Drug|dexmedetomidine|Group B, Continuous pump infusion dexmedetomidine with loading dose at 0.8µg.kg-1 over 10 minutes,followed continuous pump infusion dexmedetomidine at 0.5µg.kg-1.h-1 until 30 minutes before end of operation
16091634|NCT02224443|Drug|normal saline|Group C , Normal saline infusion will be given with the same infusion volume as group A and B
16091635|NCT02224443|Drug|midazolam,fentanyl,etomidate,Cisatracurium besylate|Anesthesia induction : 0.05 mg.kg-1 midazolam,4~5μg.kg-1 fentanyl,1.0~1.5mg.kg-1etomidate and 0.15 mg.kg-1Cisatracurium besylate
16091636|NCT02224443|Drug|cisatracurium besylate,propofol,remifentanil,sevoflurane|Maintenance of anesthesia :Continuous pump infusion 0.05~0.1mg.kg-1.h-1cisatracurium besylate,4~8mg.kg-1.h-1propofol,0.1~0.2μg.kg-1.min-1 remifentanil and sevoflurane inhalation with 0.6%~1.0%
16091637|NCT02224430|Device|schizophrenia/schizoaffective disorder.|Participants with schizophrenia/schizoaffective disorder will be observed remotely and at weekly/biweekly laboratory visits over a period of 16 weeks or until relapse occurs.
16091638|NCT02224417|Behavioral|Diabetes Educational Program (DEP)|"Participants in this Arm will receive the Diabetes Educational Program (DEP), as required, which is part of usual care at the Polyclinic. It is delivered by a Health Counsellor at the point of diagnosis and focused education is provided during doctor visits for medication. The program at the Polyclinic comprises information on a series of diabetes-related issues.
~The participant will receive the 2 or 3 study devices (patients will receive a glucometer if they do not already have one). The Site Study Coordinator will provide education on the use of the Fitbit Zip™ and the eCAP™. As part of usual care, patients who have difficulties with their glucometer will be referred to a Health Counsellor at the Polyclinic."
16091639|NCT02224417|Behavioral|DEP + Process Incentive|"Participants will receive the DEP as required. In addition, participants will have the opportunity to earn financial incentives (in vouchers) for meeting specified goals:
~SGD3.50 weekly for meeting Glucose testing goals: measuring blood glucose on three non-consecutive days each week.
~SGD0.50 daily for Medication adherence: taking medications daily as prescribed, monitored by eCAP device. Assessed based on medication-taking times within specified time windows. Participants should be adherent at all specified mealtimes to be fully adherent for the day.
~SGD1.00 daily for Regular Physical activity: taking 8,000 steps during the day as recorded by Fitbit."
16091640|NCT02224417|Behavioral|DEP + Outcome Incentive|"Participants will receive the DEP as required. In addition, participants will have the opportunity to earn financial incentives (in vouchers) for recording glucose readings within the normal range (i.e. between 4 to 7mmols/L two before a meal) on 3 non-consecutive days within the week using the glucometer.
~SGD 2 weekly if one glucose readings falls within the normal range,
~SGD 7 weekly if two glucose readings fall within the normal range,
~SGD 14 weekly if all three glucose readings fall within the normal range."
16091641|NCT02224404|Device|Fast Gelling Dressing (Exufiber)|
16091642|NCT02224391|Behavioral|Computer-Assisted Smoking Cessation Intervention|Receive ABM training via a smartphone
16091643|NCT02224391|Other|Laboratory Biomarker Analysis|Correlative studies
16091644|NCT02224391|Drug|Nicotine Patch|Given via transdermal patch
16091645|NCT02224391|Other|Questionnaire Administration|Ancillary studies
16091646|NCT02224391|Other|Sham Intervention|Undergo sham training
16091647|NCT02224378|Procedure|peep induced CVP|
16091648|NCT02224378|Procedure|passive leg raising(PLR)|
16091649|NCT02224365|Dietary Supplement|Apple|12 weeks of 75 g dried apple powder taken in 480 ml per day.
16091650|NCT02224365|Dietary Supplement|Placebo|12 weeks of 75 g apple-flavored placebo powder taken in 480 ml per day.
16091651|NCT02224352|Device|Functional neuromuscular electrical stimulation|
16091652|NCT02224313|Drug|oral estradiol 1.0 mg|one tablet of oral estradiol 1.0 mg once a day for 28 days
16091653|NCT02224313|Drug|oral progesterone 100 mg|one tablet of oral progesterone 100 mg once a day for 14 days
16091675|NCT02224157|Drug|budesonide/formoterol 'as needed' + budesonide placebo bid|Symbicort (budesonide/ formoterol) 160/4.5 μg powder for inhalation 'as needed' plus Pulmicort placebo 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment
16091676|NCT02224157|Drug|budesonode bid + terbutaline 'as needed'|Pulmicort (budesonide) 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening) plus terbutaline 0.4 mg powder for inhalation 'as needed', 52-week treatment
16091654|NCT02224300|Behavioral|Internet-based education of venous leg ulcer nursing care|Intervention is delivering the ELC (Electronic Learning of venous leg ulcer nursing care) to home health-care nurses (registered nurses, public health nurses and licensed practical nurses) . The ELC development was based on the integrative literature review about nurses' knowledge gaps on venous leg ulcer nursing care. The pedagogical basis of the ELC is constructivism and blended learning approach. The ELC comprises contact learning and distance learning. Content of ELC is evidence-based information already existing in Internet and the basis of the information is the Finnish Current Care Guidelines for Chronic leg ulcers (2014), which are evidence-based clinical practice guidelines. They are intended as basis for ulcer treatment decisions, and guidelines can be used by nurses and other healthcare professionals.
16091655|NCT02224287|Procedure|Technologist control of fluoroscopy|Technologist control of fluoroscopy
16091656|NCT02224287|Procedure|Surgeon control of fluoroscopy|Surgeon control of fluoroscopy
16091657|NCT02224274|Drug|Clopidogrel|
16091658|NCT02224274|Drug|Ticagrelor|
16091659|NCT02224261|Other|Physical Therapy protocol|"Physical therapy protocol includes manual lymph-drainage technique in axilla, and proximal ipsilateral arm, specific thumb manual lymph-drainage on the taut cords to make them gradually more flexible, in conjunction with progressive active and action-assisted arm exercises stretching cords, and patient education."
16091660|NCT02224261|Other|Control|Control protocol includes standard progressive active and action-assisted arm exercises & patient education.
16091661|NCT02224248|Behavioral|Health checks with fitness testing|Fitness testing as part of a preventive health check compose the intervention in this trial. Thus, the intervention group will receive preventive health checks with fitness testing.
16091662|NCT02224248|Behavioral|Health checks without fitness testing|The active comparator will not receive fitness testing as part of the preventive health checks. With the exception of fitness testing, the preventive health checks in the active comparator group and the intervention group are identical.
16091663|NCT02224235|Drug|Aspirin|75-325 mg q.d. aspirin until study completion (recommended indefinitely for stent patients)
16091664|NCT02224235|Device|Resolute Integrity DES|Resolute Integrity DES
16091665|NCT02224235|Device|COBRA PzF|
16091666|NCT02224235|Drug|DAPT|At the discretion of the investigator as to which DAPT is administered (per local practice)
16091667|NCT02224209|Device|Abbott EPD systems (Accunet/Emboshield), a balloon, stent|"Standard method of endovascular interventional treatment:
~Method of stage-1 angioplasty
~The stent can be placed into the distal stenosis under Abbott EPD systems (Accunet/Emboshield) if distal filter cannot be used, balloon angioplasty can be performed under proximal protection device;
~Use a balloon with diameter of 2mm × 2cm for stage-1 dilation until angiography shows residual stenosis <70%.
~Method of stage-2:
~The stent systems (Acculink/Xact) can be placed into the distal stenosis under Abbott EPD systems (Accunet/Emboshield);
~Use an Abbott balloon (diameter of 4 ~ 6mm) for pre-dilation or post-dilation;
~After the placement of stent, the angioplasty is a success when residual stenosis is <30%."
16091668|NCT02224209|Device|a balloon, stent|"Routine stenting procedure:
~The stent systems (Acculink/Xact) can be placed into the distal stenosis under Abbott EPD systems (Accunet/Emboshield);
~Use an Abbott balloon (diameter of 4 ~ 6mm) for pre-dilation or post-dilation;
~After the placement of stent, the angioplasty is a success when residual stenosis is <30%."
16091669|NCT02224196|Other|manual ventilation|Anesthesia will be induced by propofol 1mg/kg via intravenous line. Once loss of eyelash reflex occurred, ultrasonography of antral area will be started by same physician. After administration of muscle relaxant (rocuronium 0.2-0.4mg/kg), manual ventilation will be performed with respiratory rate 20 breathes/min, I:E ratio of 1:1 and tidal volume with 9-10mL/kg. The pop-off valve will be set at 15cmH2O at fixed gas flow of 500mL/min of oxygen. Pressure-controlled ventilation will be performed with respiratory rate 20 breaths/min, I:E ratio of 1:1 and peak airway pressure will be set to get a tidal volume of 9-10mL/kg. The peak airway pressure during facemask ventilation will be checked. Another physician will auscultate the epigastric area to detect gastric insufflation during facemask ventilation. Ultrasonography of antral area will be checked once again after 3 minutes of facemask ventilation.
16091670|NCT02224196|Other|pressure-controlled ventilation|Anesthesia will be induced by propofol 1mg/kg via intravenous line. Once loss of eyelash reflex occurred, ultrasonography of antral area will be started by same physician. After administration of muscle relaxant (rocuronium 0.2-0.4mg/kg), manual ventilation will be performed with respiratory rate 20 breathes/min, I:E ratio of 1:1 and tidal volume with 9-10mL/kg. The pop-off valve will be set at 15cmH2O at fixed gas flow of 500mL/min of oxygen. Pressure-controlled ventilation will be performed with respiratory rate 20 breaths/min, I:E ratio of 1:1 and peak airway pressure will be set to get a tidal volume of 9-10mL/kg. The peak airway pressure during facemask ventilation will be checked. Another physician will auscultate the epigastric area to detect gastric insufflation during facemask ventilation. Ultrasonography of antral area will be checked once again after 3 minutes of facemask ventilation.
16091671|NCT02224183|Behavioral|Education|Individuals randomized to the education group will receive The Back Pain Helpbook, an educational book with strategies for self-care including an exercise program, lifestyle modification, and tips for managing flare-ups. In addition, they will receive an assignment sheet outlining specific chapters to read over the course of the 12-weeks. In addition, participants receive at 3, 6, 9, and 12 weeks newsletters highlighting main points from the assigned chapters.
16091672|NCT02224183|Behavioral|Yoga|Weekly yoga classes will each be taught by two yoga instructors. Classes will be 75 minutes long. Mats and props will be provided. Yoga participants will be encouraged to practice for 30 minutes on days when they do not have class. They will be provided free of charge with a participant handbook, mat, block, and strap to aid home practice. Yoga home practice videos will be placed online for home practice and the website will track time spent using the videos for home practice. DVDs will be provided for those that do not have consistent access to the internet at home.
16091673|NCT02224170|Drug|Lidocaine|Lidocaine 2mg Kg-1 in normal saline (total volume 25mL) was infused after tracheal intubation, and lidocaine was infused at the rate of lidocaine 2mg Kg-1 h-1 (0.2 ml Kg-1 h-1, equivalent volume as normal saline in dexamethasone group) until the end of surgery (at the time of skin closure).
16091674|NCT02224170|Drug|Dexamethasone|Dexamethasone 8mg in normal saline (total volume 25mL) was infused after tracheal intubation, and normal saline was continuously infused at the rate of 0.2 ml Kg-1 h-1 until the end of surgery (at the time of skin closure).
16091677|NCT02224144|Drug|Vitamin D3|Vitamin D3 1000 IU per day for 12 months
16091682|NCT02224118|Drug|CNTO 3649 10 mcg/kg|A single dose of 10 mcg/kg of CNTO 3649 will be administered as subcutaneous injection to healthy adult Japanese men.
16091683|NCT02224118|Drug|CNT0 3649 30 mcg/kg|A single dose of 30 mcg/kg of CNTO 3649 will be administered as subcutaneous injection to healthy adult Japanese men and multiple doses of 30 mcg/kg of CNTO 3649 will be administered to participants with type 2 diabetes mellitus as subcutaneous injections once weekly for 4 weeks.
16091684|NCT02224118|Drug|CNTO 3649 100 mcg/kg|A single dose of 100 mcg/kg of CNTO 3649 will be administered as subcutaneous injection to healthy adult Japanese men and multiple doses of 100 mcg/kg of CNTO 3649 will be administered to participants with type 2 diabetes mellitus as subcutaneous injections once weekly for 4 weeks.
16091685|NCT02224118|Drug|CNTO 3649 300 mcg/kg|A single dose of 300 mcg/kg of CNTO 3649 will be administered as subcutaneous injection to healthy adult Japanese men.
16091686|NCT02224118|Drug|Placebo|Matching Placebo to CNTO 3649 will be administered to both healthy volunteers and participants with type 2 diabetes mellitus.
16091687|NCT02224105|Drug|BI 653048 BS|
16091688|NCT02224105|Drug|Prednisolone low|
16091689|NCT02224105|Drug|Prednisolone high|
16091690|NCT02224105|Drug|Placebo|
16091691|NCT02224105|Drug|sodium chloride infusion|
16091692|NCT02224105|Drug|endotoxin escherichia coli (E. coli) lipopolysaccharide (LPS)|
16091693|NCT02224092|Dietary Supplement|multivitamin multimineral with phytonutrient supplementation|"The multivitamin multimineral with phytonutrient product consists of four tablets per dose, two Vitamin tablets, a Mineral tablet, and a Phytonutrient tablet. The placebo for this trial will be formulated to match the shape and color of all multivitamin multimineral with phytonutrient product tablets, e.g., a Vitamin Placebo, a Mineral Placebo and a Phytonutrient Placebo."
16091694|NCT02224079|Drug|BIIB 722 CL|
16091695|NCT02224079|Drug|Placebo|Hydroxypropyl-beta-cyclodextrin (HPβCD)
16091696|NCT02224066|Drug|Ticagrelor 90 mg twice per day during three months following TAVI|
16091697|NCT02224066|Drug|Aspirin 100 mg plus Clopidogrel 75 mg daily during three months following TAVI|
16091698|NCT02224053|Procedure|Pharmacokinetic sampling - AZD9291|Blood sampling to measure AZD9291
16091699|NCT02224053|Drug|AZD9291 tablet dosing|AZD9291 80mg tablet taken on Day 5 in Period 1 and Day 1 in Period 2.
16091700|NCT02224053|Drug|Omeprazole tablet dosing|Omeprzole taken from Days 1 to 5 in Period 1.
16091701|NCT02224053|Procedure|Pharmacokinetic sampling - AZ5140 and AZ7550|Blood samples to measure levels of AZ5140 and AZ7550
16091702|NCT02224040|Drug|ceftriaxone|
16091703|NCT02224040|Drug|ceftriaxone and azithromycin|
16091704|NCT02224040|Drug|azithromycin|
16091705|NCT02224040|Drug|azithromycin and cefixime|
16091706|NCT02224027|Device|proceal laryngeal mask airway|In proceal laryngeal mask group, proceal laryngeal mask airway is inserted by novices.
16091707|NCT02224027|Device|tracheal tube|In tracheal tube group, tracheal tube is intubated by novices.
16091708|NCT02224027|Device|i-gel|In i-gel group, i-gel is inserted by novices.
16091709|NCT02224014|Drug|Lendormin D tablets|
16091710|NCT02224001|Procedure|The Flag Technique|"A New Concept in the Tip Plasty of Asian Rhinoplasty : The Flag Technique by Use of Only A Septal Cartilage without Septal Extension Grafts
~The investigators propose the new technique, so called 'Flag Technique' by a tip-strut complex in a flag-like shape : using only the septal cartilage as an elongated columellar septal strut graft, a shield graft , bilateral mini-spreader grafts of the upper part in the elongated columellar septal strut graft without the septal extension graft to achieve the desired the result."
16091711|NCT02223988|Procedure|subglottic secretion removal|
16091712|NCT02223962|Behavioral|Physical activity|Counseling about physical activity will only be provided in the intervention group by 3 weekly telephone contacts. Based on the information the physiotherapist receives, he or she will adapt the goal (in agreement with the patient) and motivate the patient to reach the individual goal.
16091713|NCT02223949|Device|Cook double balloon catheter|
16091714|NCT02223949|Drug|PGE1 tablet|
16091715|NCT02223936|Other|group exposed|Assessment by Brunet Lezine scale
16091716|NCT02223936|Other|Control|Not exposed group
16091717|NCT02223923|Drug|AZD6738|
16091718|NCT02223923|Radiation|Palliative radiotherapy|
16091719|NCT02223910|Procedure|Neurofeedback training of functional connectivity|
16091720|NCT02223897|Drug|huc-MSCs|Received conventional treatment and huc-MSCs once per week for the first month and once per month for 6 months(9 times in total), at a dose of 1×106 huc-MSCs/kg body weight.
16091721|NCT02223897|Drug|Placebo|Received conventional treatment and 50 ml saline solution once per week for the first month and once per month for 6 months(9 times in total).
16091722|NCT02223884|Drug|docetaxel 35mg/m2|D1, 8 docetaxel 35 mg/m2 D1, 8 carboplatin AUC 3 every 3 weeks
16091723|NCT02223884|Drug|Carboplatin AUC3|D1, 8 docetaxel 35 mg/m2 D1, 8 carboplatin AUC 3 every 3 weeks
16091724|NCT02223871|Drug|ACT-451840:|ACT-451840 500 mg was provided in 100 mL amber glass bottles formulated as a powder for oral suspension. The ACT-451840 suspension was prepared extemporaneously by addition of 25 mL of water and administered orally under fed condition.
16091725|NCT02223871|Other|Plasmodium falciparum-infected human erythrocytes:|Each participant was inoculated on Day 0 with approximately 1,800 viable Plasmodium falciparum-infected human erythrocytes administered intravenously.
16091726|NCT02223871|Drug|Artemether 20 mg and lumefantrine 120mg combination tablet:|Rescue treatment to ensure clearance of Plasmodium falciparum comprising six doses of four tablets (total course of 24 tablets) given over a period of 60 hours. Each dose of tablets administered orally was immediately followed by food or drinks rich in fat (e.g., milk).
16091727|NCT02223871|Drug|Primaquine:|Rescue treatment to ensure clearance of Plasmodium falciparum, to be taken as a single oral 45 mg dose with food only if gametocytes were identified after administration of Riamet® rescue medication.
16091775|NCT02223455|Other|Hand Hygiene Signs|Hand hygiene signs will not be changed (control) or change weekly/monthly on wards/units randomized to each of these study arms. Signs will be posted by the hand hygiene sanitizer outside each patient room.
16091776|NCT02223429|Drug|Oxytocin|1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays
16091956|NCT02222129|Drug|liposomal bupivacaine|
16091728|NCT02223858|Behavioral|Positive Activities (PA) Program|6-week program of at-home activities (1 per week) that have been shown to increase positivity. Activities were delivered via activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. Interventionist oriented participants to the booklets and reviewed the first activity at the end of an in-person baseline visit. Booklets contained all instructions patients needed to complete the full program. Interventionists also provided support via weekly calls in which they assessed completion of the previous week's activity, reviewed instructions for the next activity, and helped participants trouble-shoot anticipated barriers.
16091729|NCT02223858|Behavioral|Attention Control (AC) Program|6-week program of at-home activities (1 per week) based on affectively neutral activities from control conditions in studies of positive activities interventions. Activities were delivered via activity booklets and oral instructions provided during weekly telephone calls from trained interventionists. Interventionist oriented participants to the booklets and reviewed the first activity at the end of an in-person baseline visit. Booklets contained all instructions patients needed to complete the full program. Interventionists also provided support via weekly calls in which they assessed completion of the previous week's activity, reviewed instructions for the next activity, and helped participants trouble-shoot anticipated barriers.
16091730|NCT02223845|Other|Music|Self-selected music played via headphones
16091731|NCT02223832|Drug|ACT-128800|
16091732|NCT02223819|Drug|Crizotinib|"An anti-cancer drug acting as an anaplastic lymphoma kinase (ALK) and c-ros oncogene 1 (ROS1) inhibitor, used to treat non-small cell lung cancer (NSCLC) that has spread to other parts of the body and is caused by a defect in a gene called ALK.
~Crizotinib will be provided as capsules containing 200 or 250 mg of study medication for oral administration."
16091733|NCT02223806|Behavioral|Uterine Tonus Assessment by Midwife|Uterine tonus assessment every 15 minutes for 2 hours.
16091734|NCT02223806|Behavioral|Patient self-assessment of uterine tonus|Uterine tonus assessment by patient every 15 minutes for 2 hours.
16091735|NCT02223793|Behavioral|Information on high risk factor levels and lifestyle advice|This arm of high risk participants will be informed about their measured levels of the different cardiovascular risk factors. They will also receive information on how to lower their levels in 8 weeks
16091736|NCT02223793|Behavioral|No information on high risk factor levels but lifestyle advice|In this arm, participants will have delayed information on their risk factor levels, but they will receive general advices on how to lower levels in 8 weeks
16091737|NCT02223793|Behavioral|No information on high risk factor levels, nor lifestyle advice|In this arm, participants will have delayed information on both their risk factor levels and general information on how to lower risk factor levels.
16091738|NCT02223780|Other|early palliative care|the patients will benefit from an early palliative care consultation
16091739|NCT02223767|Device|Experimental: Verum TMS|Intensity of 100 % of the resting motor threshold with 10 Hz and ITI of 26 s. 1560 pulse in 40 trains at all . One train lasts 4 s.
16091740|NCT02223767|Device|Experimental: Sham TMS|Sham stimulation with 10 Hz and ITI of 26 s. 1560 pulse in 40 trains at all . One train lasts 4 s.
16091741|NCT02223754|Device|lotrafilcon B|Soft contact lens to be worn as daily wear, monthly replacement modality.
16091742|NCT02223754|Device|etafilcon A|Soft contact lens to be worn as daily wear, daily disposable modality.
16091743|NCT02223741|Other|Korean medical treatment|acupuncture and herbal drugs
16091744|NCT02223728|Behavioral|Lifestyle|
16091745|NCT02223728|Behavioral|Health Education|
16091746|NCT02223715|Other|CDI Pts|
16091747|NCT02223702|Drug|Amoxicillin|500 mg, 3 times per day for 7 days
16091748|NCT02223702|Drug|Metronidazole|500 mg, 3 times per day, for 7 days
16091749|NCT02223702|Drug|Moxifloxacin|400 mg, once in a day for 7 days.
16091750|NCT02223689|Procedure|Skin Affix|
16091751|NCT02223676|Procedure|Clinical pharmacists conduct medication history|pharmacists conduct medication history before the physician interviews the patient and does not spend time on conducting medical history
16091752|NCT02223650|Device|Overminus treatment|2.50D overminus spectacles
16091753|NCT02223650|Device|Non-overminus treatment|spectacles without overminus or no spectacles
16091754|NCT02223637|Biological|Meningococcal quadrivalent CRM-197 conjugate vaccine|This pregnancy registry is strictly observational. Decisions of vaccination are made by health care providers.
16091755|NCT02223624|Other|walking and light weights|
16091756|NCT02223624|Other|eccentric aerobic exercise|
16091757|NCT02223624|Other|concentric aerobic exercise|
16091758|NCT02223611|Drug|S1 capsule|Within four weeks after the completely resection, S-1 was administered orally twice a day, after meals on days 1 to 14. The actual dose of S-1 was selected as follows: in a patient with body surface area (BSA)<1.25 m2 40mg twice a day, 1.25 m2≤BSA<1.5 m2 50mg twice a day, and 1.5 m2≤BSA 60mg twice a day. Cisplatin (75 mg/m2) was administered intravenously on day 1 The treatment regimen was repeated every 3 weeks, totally 4 cycles unless disease progression or unacceptable toxicity occurred.
16091759|NCT02223611|Drug|Vinorelbine|Vinorelbine (25 mg/m2) is administered intravenously on day 1, and day 8. Cisplatin (75 mg/m2) is administered intravenously on day 1. The treatment regimen is repeated every 3 weeks, totally 4 cycles unless disease progression or unacceptable toxicity occurred.
16091760|NCT02223598|Drug|CB-5083|
16091761|NCT02223598|Drug|Dexamethasone|
16091762|NCT02223585|Other|Animal-based protein diet|
16091763|NCT02223585|Other|Vegan-based protein diet|
16091764|NCT02223572|Radiation|hip Xray|
16091765|NCT02223533|Device|19Gx500-mm Pajunk InfiltraLong® catheter|Before completing the surgery, the surgical team inserted a 19Gx500-mm Pajunk InfiltraLong® catheter with multiple perforations in the last few centimeters before the tip to allow for local anesthetic administration.
16091766|NCT02223533|Drug|morphine|After the intervention patients had access to intravenous morphine via a patient-controlled analgesia
16091767|NCT02223520|Drug|Mupirocin and Chlorhexidine|
16091768|NCT02223520|Drug|Placebo ointment and placebo cloths|
16091769|NCT02223507|Drug|BIIR 561 CL|
16091770|NCT02223507|Drug|Placebo|
16091771|NCT02223494|Drug|Terbogrel|
16091772|NCT02223481|Drug|Terbogrel low dose|
16091773|NCT02223481|Drug|Terbogrel high dose|
16091774|NCT02223481|Drug|Placebo|
16091777|NCT02223429|Drug|Vasopressin|1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays
16091778|NCT02223429|Drug|Placebo|1 ml solution in each nostril; five (5) sprays per each nostril, for a total of ten (10) sprays
16091779|NCT02223416|Drug|RGB-10|
16091780|NCT02223416|Drug|Teriparatide|
16091781|NCT02223403|Dietary Supplement|nitrate-rich beetroot juice|3 ounces of nitrate-rich beetroot juice ingested orally once 90 minutes before exercise interventions of steady state treadmill exercise followed 30 minutes later by six minute walk
16091782|NCT02223403|Dietary Supplement|nitrate-deplete beetroot juice|3 ounces of nitrate-deplete beetroot juice ingested orally once 90 minutes before exercise interventions of steady state treadmill exercise followed 30 minutes later by six minute walk
16091783|NCT02223390|Behavioral|Improving AIDS Care after Trauma (ImpACT)|
16091784|NCT02223377|Drug|Morphine|Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
16091785|NCT02223377|Drug|Hydromorphone|Participant to be asked for their pain score, and if it is more than 4 out of 10 (NAS): to receive the 1st dose within 5 minutes after coming to PACU: 0.04mg/kg morphine units (rounding off to the nearest 1 ml or 0.5 ml); with a maximum of 3 mg of morphine equivalents. Repeat doses: 0.02 mg/kg morphine units every 5-10 minutes to titrate for analgesia and side effects (rounding off to the nearest 1 ml or 0.5 ml)
16091786|NCT02223364|Drug|Peripheral nerve blocks with Bupivacaine|Subjects received Bupivacaine 0.5% preoperatively, then Bupivacaine 0.2% upon post anesthesia care unit (PACU) arrival via femoral nerve block, then Bupivacaine 0.25% via single-injection sciatic nerve.
16091787|NCT02223364|Drug|Intra articular injection with Ropivacaine|Subjects received an intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Ropivacaine dose depended upon body weight: 50-74.9 kg: 200 mg, 75-99.9 kg: 300 mg, 100-125 kg: 400 mg.
16091788|NCT02223364|Drug|Intra articular injection with liposomal bupivacaine|Subjects received an intra articular injection with liposomal bupivacaine, a total volume of 120 mL injected in the periarticular structures by the surgeon. Patients weighing 50-125 kg received 266mg of Liposomal Bupivacaine.
16091789|NCT02223351|Drug|ASP2151|
16091790|NCT02223351|Drug|ritonavir|
16091791|NCT02223338|Drug|Ciprofloxacin|Use of topical ciprofloxacin 4x daily for 3 days after intravitreal injection using standard aseptic techniques with Povidone-Iodine is a common practice intervention in the United States, and is thought by some to reduce the risk of post-injection endophthalmitis.
16091792|NCT02223338|Drug|Standard Aseptic Technique|Patients in this group will have received Povidone-Iodine Only following injections of anti-VEGF agents at least 3 times in the last 6 months.
16091793|NCT02223312|Biological|TAPA-pulsed DC vaccine|A cycle of low-dose cyclophosphamide (100mg/day) by mouth for 5 days starting seven 7 days prior to the DC vaccine cycle to reduce Treg activity. Low-dose cyclophosphamide will be taken every 14 days for six 6 cycles. A total of 6 vaccines containing 1 x 10^7 TAPA-pulsed DC will be administered SQ every 14 days. The DC vaccine is given on Day 1 of the DCV cycle plus low-dose GM-CSF 50mcg/day SQ x 5 days (Day 1 to Day 4). GM-CSF is administered for 5 days to increase monocyte production and dendritic cell precursors to optimize immune responses.
16091794|NCT02223299|Dietary Supplement|L-tyrosine|6g/d daily for 30 days
16091795|NCT02223299|Dietary Supplement|L-Tryptophan|2g/d daily for 30 days
16091796|NCT02223299|Drug|deplin|15mg daily for 30 days
16091797|NCT02223299|Other|Placebo A|a sugar-pill that looks like a real medication
16091798|NCT02223299|Other|Placebo B|a sugar-pill that looks like a real medication
16091799|NCT02223286|Diagnostic Test|Corus CAD|Age/Sex/Gene Expression Score
16091800|NCT02223273|Behavioral|Multifaceted Strategy|"Simulation Based Team Training
~Case Manager: a trained person who works in the hospital and is responsible for ensuring the usage of all interventions
~Reminders -
~Check lists - decision support algorithm
~Distribution of educational materials: guidelines and recommendations for best practices"
16091801|NCT02223260|Drug|dabigatran|Experimental dose chosen based on age and weight
16091802|NCT02223247|Drug|TVB-2640|
16091803|NCT02223234|Behavioral|Emails and 4 Home Visits|Weekly emails and 4 home visits with health educator
16091804|NCT02223234|Behavioral|Control|Monthly emails on child health
16091805|NCT02223234|Behavioral|Emails and 2 home visits|Weekly emails and 2 home visits with health educator
16091806|NCT02223221|Procedure|IVF/ICSI|In vitro fertilization or intracytoplasmic sperm injection.
16091807|NCT02223221|Genetic|PGS|Selection of embryos are based on SNP-array-based preimplantation genetic screening for the number of all chromosomes on the 5th day of IVF/ICSI.
16091808|NCT02223221|Other|Without PGS|Selection of embryos are based on morphology criteria on the 5th day of IVF/ICSI.
16091809|NCT02223208|Drug|Ro-CHOEP-21 (PHASE I)|"Romidepsin (dose escalation) Starting dose: 12mg/ms iv day +1 and +8
~Dose modification according to toxicity:
~14mg/ms day +1 and +8
~10mg/ms day +1 and +8
~8mg/ms day +1 and +8
~CHOEP-21
~Doxorubicin 50 mg/ms iv day +1 or +2,
~Vincristin 1.4 mg/ms (maximum 2.0 mg total dose) iv day+1 or +2
~Cyclophosphamide 750 mg/ms iv day +1 or +2
~Etoposide 100mg/ms iv from day +1 to +3 or from day +2 to +4
~Prednisone100 mg orally from days +1 to +5 or from days +2 to +6
~PR or CR:Ro-CHOEP-21 for 3 additional cycles followed by stem cell mobilization and transplantation phase (CR --> AUTO-SCT, PR --> ALLO-SCT)"
16091810|NCT02223208|Drug|Ro-CHOEP-21 (PHASE II)|"Ro-CHOEP-21 x 3 cycles
~Romidepsin dose according to phase I iv day +1 and +8
~Doxorubicin 50 mg/ms iv day +1 or +2,
~Vincristin 1.4 mg/ms (maximum 2.0 mg total dose) iv day+1 or +2,
~Cyclophosphamide 750 mg/ms iv day +1 or +2
~Etoposide 100mg/ms iv from day +1 to +3 or from day +2 to +4
~Prednisone100 mg orally from days +1 to +5 or from days +2 to +6
~PR or CR: Ro-CHOEP-21 for 3 additional cycles followed by stem cell mobilization and transplantation phase (CR --> AUTO-SCT, PR --> ALLO-SCT)"
16091811|NCT02223182|Biological|Viaskin Milk 150 mcg|Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 150 mcg cow's milk proteins.
16091812|NCT02223182|Biological|Viaskin Milk 300 mcg|Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 300 mcg cow's milk proteins.
16091813|NCT02223182|Biological|Viaskin Milk 500 mcg|Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing 500 mcg cow's milk proteins.
16091814|NCT02223182|Biological|Viaskin Placebo|Subjects epicutaneously administered daily (up to 24 hours application per day) with a patch containing a matching placebo formulation.
16091815|NCT02223169|Dietary Supplement|Egg albumin-derived peptide|Double-blind intervention study cross-over design with one sachet containing 3g Egg albumin-derived peptide (Tensio-control) or placebo (maltodextrin) in Phase one followed by cross-over in Phase 2.
16091816|NCT02223130|Behavioral|Cognitive Behavioral Therapy techniques|Participants attend 9 weekly group sessions. Each of the weekly sessions is led by a mental health professional and a peer facilitator who use Cognitive Behavioral Therapy techniques to work with participants in tracking their cognitions, emotions and behaviors in response to stressful/discrimination experiences.
16091817|NCT02223117|Biological|Thrombosomes|Freeze-dried platelets
16091818|NCT02223117|Biological|Placebo|
16091819|NCT02223104|Device|Flexima Active|
16091820|NCT02223104|Device|Sensura|
16091821|NCT02223091|Behavioral|Consultation by a trained physician|
16091822|NCT02223091|Behavioral|Consultation by an untrained physician|
16091823|NCT02223078|Biological|G17DT|
16091824|NCT02223078|Biological|Placebo Comparator|
16091825|NCT02223065|Drug|Saxagliptin|
16091826|NCT02223065|Drug|Dapagliflozin|
16091827|NCT02223052|Drug|CC-486|Arm 1: Two 150-mg tablets of CC-486 on Day 1 and 1 x 300 mg CC-486 on Day 2 Arm 2: 1 x 300mg tablet of CC 486 on Day 1 and 2 x 150mg CC-486 on Day 2
16091828|NCT02223052|Drug|Vidaza|75mg/m^2 IV or SC daily x 7 days every 4 weeks for ≤ 6 (four-week) cycles
16091829|NCT02223039|Biological|AbGn-168H|AbGn-168H monoclonal antibody
16091830|NCT02223039|Biological|Placebo|Placebo of AbGn-168H
16091831|NCT02223026|Drug|Linagliptin/metformin FDC|
16091832|NCT02223026|Other|high-fat, high caloric meal|
16091833|NCT02223013|Drug|BIBV 308 SE solution|
16091834|NCT02223013|Drug|BIBV 308 SE capsule L|
16091835|NCT02223013|Drug|BIBV 308 SE capsule S|
16091836|NCT02223000|Drug|BIBV 308 SE solution|
16091837|NCT02223000|Drug|BIBV 308 SE capsule 1|
16091838|NCT02223000|Drug|BIBV 308 SE capsule 2|
16091839|NCT02222987|Drug|Terbogrel|
16091840|NCT02222987|Drug|Clopidogrel|
16091841|NCT02222974|Drug|BIIR 561 CL|
16091842|NCT02222974|Drug|Placebo|
16091843|NCT02222961|Drug|BIIR 561 CL|
16091844|NCT02222961|Drug|Placebo|
16091845|NCT02222948|Drug|Vatelizumab|"Pharmaceutical form: solution for infusion
~Route of administration: intravenous"
16091846|NCT02222948|Drug|Placebo (for Vatelizumab)|"Pharmaceutical form: solution for infusion
~Route of administration: intravenous"
16091847|NCT02222935|Behavioral|Balance Exercise Training|Balance exercise - 5 type (single leg squat, dead lift, step ups, forward reaches), 10 Repetition Maximum, 2 sets, five times a week and 2 weeks
16091848|NCT02222935|Behavioral|Routine Back exercise program|Back strengthening 5 exercises - pelvic bridges, prone plank, side plank, dead bug and prone lift ups, 10 Repetition Maximum, 2 sets, five times a week, 2 weeks
16091849|NCT02222922|Drug|PF-06647020 Q3W|"Part 1: PF-06647020 will be administered intravenously every 21 days in cohorts of 2-4 patients starting at a dose of 0.20mg/kg. Increases in dose will continue until MTD is determined.
~Part 2: Patients with triple negative breast cancer (pre-selected for PTK7 moderately high to high expression), non small cell lung cancer (pre-selected with moderate to high PTK7 expression) and ovarian cancer patients (unselected for PTK7 expression) will be treated at the MTD or Recommended Phase 2 Dose selected in Part 1."
16091850|NCT02222922|Drug|fluconazole|combination drug used for drug-drug interaction sub-study
16091851|NCT02222922|Drug|PF-06647020 Q2W|"Part 1: PF-06647020 will be administered intravenously every 14 days in cohorts of 2-4 patients starting at a dose of 2.1 mg/kg. Increases in dose will continue until MTD is determined.
~Part 2: Patients with non-small cell lung cancer (pre-selected for PTK7 moderate to high expression and ovarian cancer patients (unselected for PTK7 expression) will be treated at the MTD or Recommended Phase 2 Dose selected in Part 1."
16091852|NCT02222922|Drug|PF-06647020 combined with Avelumab|Part 2: Patients with ovarian cancer (unselected for PTK7 expression) will be treated with PF-0664702 plus Avelumab.
16091853|NCT02222909|Other|Co-developed IT intervention|The IT-based intervention is being co-developed with the community based organizations in the intervention group, and comprises tools to improve referral and tracking of clients, use of volunteers, and direct communication with hospital staff members
16091854|NCT02222896|Drug|Chlorhexidine Gluconate|2% CHG solution on cloth
16091855|NCT02222896|Other|Vehicle|Excipients of CHG product only
16091856|NCT02222896|Drug|DynaHex-2|2% CHG solution
16091857|NCT02222883|Genetic|Testing of BRCA status regarding germline and somatic mutation|
16091858|NCT02222870|Biological|Fluzone® Quadrivalent Influenza Vaccine, No Preservative|0.25 mL, Intramuscular (Pediatric Dose, 2014-2015 formulation)
16091859|NCT02222870|Biological|Fluzone® Quadrivalent Influenza Vaccine, No Preservative|0.5 mL, Intramuscular (2014-2015 formulation)
16091860|NCT02222844|Other|Preoperative MRI scan|Standard preoperative CT of abdomen, chest and pelvis plus interventional preoperative MRI scan.
16091861|NCT02222831|Procedure|Day 0 denudation and time lapse culture on IVF-oocytes.|
16091862|NCT02222818|Device|Conducted AF Response (CAFR)|The CAFR algorithm is currently available in the Medtronic market-released devices and intended to promote delivery of CRT pacing during conducted AT/AF episodes.
16091863|NCT02222818|Device|Conducted AF Response Plus (CAFRPlus)|The CAFRPlus algorithm is part of the CRTee feature set. This feature set has a diagnostic element that tracks the loss of effective CRT pacing that is occurring over time, both during normal sinus rhythm (NSR) and during AF. It also has an interventional element (i.e. CAFRPlus) that uses this evaluation of effective CRT pacing to adjust the pacing rate during AF to decrease loss of effective CRT pacing.
16091864|NCT02222805|Procedure|Early (≤30 seconds) cord clamping|Early (≤30 seconds) cord clamping of the umbilical cord after delivery.
16091865|NCT02222805|Procedure|Delayed (≤180 seconds) cord clamping|Delayed (≤180 seconds) cord clamping of the umbilical cord after delivery.
16091957|NCT02222116|Device|MGuard Prime|
16091866|NCT02222766|Behavioral|Parents and Tots Together Program|Group-based parenting program, 9 sessions offered weekly
16091867|NCT02222766|Behavioral|Control|Minimal attention control- 9 weekly mailed information on general child development
16091868|NCT02222740|Drug|10 mg of Hydrocodone Bitartrate Extended Release (HC-ER)|Schedule II Class
16091869|NCT02222740|Drug|20 mg of Hydrocodone Bitartrate Extended Release (HC-ER)|Schedule II Class
16091870|NCT02222727|Drug|Donepezil|Loading 20 mg dose of donepezil on first day of recruitment followed by once daily 5 mg dose for subsequent twenty days
16091871|NCT02222714|Biological|3K3A-APC|3K3A-APC, diluted in 0.9% sodium chloride in water, given as 100 mL IV infusion
16091872|NCT02222714|Drug|Placebo|Matching placebo, 0.9% sodium chloride in water, given as 100 mL IV infusion
16091873|NCT02222688|Drug|cirmtuzumab|
16091874|NCT02222675|Procedure|Sonography assisted breast surgery|
16091875|NCT02222675|Procedure|Conventional breast surgery|
16091876|NCT02222662|Other|Parent massage tx group|The parent-delivered massage is based on Chinese medicine. There are specific techniques for each area of difficulty, e.g. the head, fingers, and toes. After a few months, massage becomes relaxing and enjoyable, and parent touch comes back into use to effectively help the child self-regulate.
16091877|NCT02222662|Other|Parent massage wait-list control group|The parent-delivered massage is based on Chinese medicine. There are specific techniques for each area of difficulty, e.g. the head, fingers, and toes. After a few months, massage becomes relaxing and enjoyable, and parent touch comes back into use to effectively help the child self-regulate.
16091878|NCT02222649|Dietary Supplement|Vitamin D3|High dose of 200,000 IU of cholecalciferol orally in a single dose
16091879|NCT02222649|Dietary Supplement|Placebo|Capsules of starch, no therapeutic action
16091880|NCT02222636|Drug|Normal saline,1 milliliter|Normal saline,1 milliliter, 20 minutes before anaesthetic induction
16091881|NCT02222636|Drug|Dexmedetomidine 1 μg.kg-1,1 milliliter|Dexmedetomidine 1 μg.kg-1,1 milliliter,20 minutes before anesthesia induction
16091882|NCT02222636|Drug|Dexmedetomidine 2μg.kg-1,1 milliliter|Dexmedetomidine 2μg.kg-1,1 milliliter,20 minutes before anesthesia induction
16091883|NCT02222636|Drug|Anesthesia induction, 8% sevoflurane|Inhalation induction with 8% sevoflurane
16091884|NCT02222636|Drug|Anesthesia maintenance, 2%~3% sevoflurane,fentanyl|2%~3% sevoflurane,inhalation. fentanyl,2μg.kg-1.min-1,intravenous infusion
16091885|NCT02222623|Drug|Glargine|Glargine given as 100% total daily dose with breakfast. The initial dose will be calculated using the patient's weight or using their basal insulin doses prior to hospitalization.
16091886|NCT02222623|Drug|NPH|NPH 2/3 of the total daily dose given with breakfast, 1/3 of the total daily dose given at bedtime. The initial dose is calculated using the patient's weight or using the basal insulin dose prior to hospitalization.
16091887|NCT02222610|Drug|0.5 mg ranibizumab|
16091888|NCT02222610|Procedure|Targeted Retinal Photocoagulation (TRP)|TRP to areas of retinal ischemia
16091889|NCT02222597|Device|infrascanner|
16091890|NCT02222571|Behavioral|Parents and Tots Together Program|Group-based parenting program, 9 weeks delivered in a community setting
16091891|NCT02222571|Behavioral|Supervision for Safety|group-based safety intervention for parents
16091892|NCT02222558|Drug|TSX-002|TSX-002 are capsules with testosterone as the active ingredient.
16091893|NCT02222545|Biological|OMS721|
16091894|NCT02222532|Drug|Tetronine|Oral T3 was given 1 microgram/kgBW q6h since induction of anesthesia for 11 doses (for 60 hours)
16091895|NCT02222532|Drug|Placebo|Placebo was sacharum lactis, given q6h since induction of anesthesia for 11 doses (for 60 hours)
16091896|NCT02222519|Drug|Rocuronium|Rocuronium 0.6mg/kg iv single dose
16091897|NCT02222506|Device|KLOX BioPhotonic System|KLOX BioPhotonic System (Multi-LED Light and KLOX Photo Converter Wound Gel) will be administered until wound closure or for a maximum of 24 weeks, followed by a 8-week follow-up period, in association with Standard Of Care for diabetic foot ulcers.
16091898|NCT02222493|Biological|PF-06438179|PF-06438179 will be administered by intravenous infusion at an initial dose of 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
16091899|NCT02222493|Biological|Infliximab|Infliximab will be administered by intravenous infusion at an initial dose of 3 mg/kg at 0, 2 and 6 weeks, then every 8 weeks.
16091900|NCT02222480|Drug|Fimasartan|
16091901|NCT02222480|Drug|Hydrochlorothiazide|
16091902|NCT02222480|Drug|Placebo|
16091903|NCT02222467|Device|KLOX BioPhotonic System|KLOX BioPhotonic System (Multi-LED Light and KLOX Photo Converter Wound Gel) will be administered until wound closure or for a maximum of 16 weeks, followed by a 8-week follow-up period, in association with Standard Of Care for venous leg ulcers.
16091904|NCT02222454|Device|KLOX BioPhotonic System|KLOX BioPhotonic System (Multi-LED Light and KLOX Photo Converter Wound Gel) will be administered until wound closure or for a maximum of 16 weeks, followed by a 8-week follow-up period, in association with Standard Of Care for pressure ulcers.
16091905|NCT02222441|Drug|Palbociclib alone|A single 125 mg dose of palbociclib free base capsule given orally alone in the fed state, followed by 120 hours of PK sample collection.
16091906|NCT02222441|Drug|Palbociclib plus Modafinil|For Cohort 1, modafinil 200 mg once daily for 7 days, followed by 400 mg once daily for 25 days; on Day 28, a single oral 125 mg dose of palbociclib will be given with modafinil after a meal, followed by 120 hours of PK sample collection.
16091907|NCT02222441|Drug|Palbociclib alone|A single 125 mg dose of palbociclib free base capsule given orally alone in the fed state, followed by 120 hours of PK sample collection.
16091908|NCT02222441|Drug|Palbociclib plus pioglitazone|For Cohort 2, pioglitazone 45 mg once daily for a total of 19 days; On Day 15, a single oral 125 mg dose of palbociclib will be given with pioglitazone after a meal, followed by 120 hours of PK sample collection.
16091909|NCT02222428|Drug|BI 1744 CL/BI 54903 XX FDC|
16091910|NCT02222428|Drug|BI 54903 XX|
16091911|NCT02222428|Drug|BI 1744 CL|
16091912|NCT02222415|Dietary Supplement|Exercise + Protein drink|
16091913|NCT02222402|Behavioral|INTRA-DIALYTIC EXERCISE TRAINING|
16091950|NCT02222168|Drug|BI 409306|medium dose, oral administration
16091951|NCT02222155|Drug|CCX168 low dose plus standard of care|
16091952|NCT02222155|Drug|CCX168 high dose plus standard of care|
16091953|NCT02222155|Other|Placebo BID plus standard of care|
16091914|NCT02222389|Behavioral|CM for Alcohol|"Escalating reinforcement for alcohol abstinence.
~Alcohol-negative CM Participants draw chips out of a bowl containing 500 chips. Fifty percent of the chips will say good job! or a similar encouraging phrase, 41.8% of the chips will result in a small prize, 8% will result in a large prize, and 0.2% will result in a jumbo prize."
16091915|NCT02222389|Behavioral|CM for drugs|"Escalating reinforcement for drug abstinence.
~Drug-negative participants will be invited to draw chips out of a bowl containing 500 chips. Fifty percent of the chips will say good job! or a similar encouraging phrase, 41.8% of the chips will result in a small prize, 8% will result in a large prize, and 0.2% will result in a jumbo prize."
16091916|NCT02222389|Behavioral|CM for both substances|"Escalating reinforcement for drug and alcohol abstinence.
~Drug- and alcohol-negative participants will be invited to draw chips out of a bowl containing 500 chips. Fifty percent of the chips will say good job! or a similar encouraging phrase, 41.8% of the chips will result in a small prize, 8% will result in a large prize, and 0.2% will result in a jumbo prize."
16091917|NCT02222389|Behavioral|Non-Contingent group|Compensation for Non-Contingent control group participants is dependent only on providing urine samples, regardless of whether the urine tests are negative for alcohol and/or drugs.
16091918|NCT02222376|Drug|Pirfenidone|Twice a day topical application
16091919|NCT02222376|Procedure|Debridement|Weekly ulcer debridement
16091920|NCT02222363|Drug|VLX600|Patients will receive a dose of VLX600 by 4-hr intravenous infusion using a central venous catheter on Days 1, 8, and 15 of each 28-day treatment cycle. There are the following dose cohorts: 10, 20, 40, 80, 160, and 210 mg VLX600. It is anticipated that patients will receive 6 treatment cycles. In the absence of unacceptable toxicity and disease progression, patients have the option of continuing treatment beyond 6 cycles, if the investigator determines that the patient may benefit further from it.
16091921|NCT02222350|Drug|10mg DS-8500a tablet|
16091922|NCT02222350|Drug|75mg DS-8500a tablet|
16091923|NCT02222350|Drug|placebo|
16091924|NCT02222337|Behavioral|Nueva Vida Intervention|The psycho-educational format of the Nueva Vida Intervention is led by trained interventionists who have the survivors and caregivers go into different rooms to discuss the same topic. This format will allows them each to express their thoughts and feelings without inhibitions or concerns over how their survivor or their caregiver might respond. The specific topics for each wave of the intervention participants will be determined from a larger list of possible topics, with each group including the following core topics: Impact of Cancer on the Family, Spirituality and Cancer, Stress Management, Balancing Physical and Emotional Needs and Improving Communication.
16091925|NCT02222324|Drug|Placebo|8 placebo tablets matching E2609
16091926|NCT02222324|Drug|E2609|E2609 will be administered as 8 tablets
16091927|NCT02222324|Drug|Moxifloxacin|Administered as 1 tablet with 7 tablets of placebo matching E2609
16091928|NCT02222311|Other|Blood Samples|
16091929|NCT02222298|Procedure|Video assisted ablation of pilonidal sinus|A 5-phases' technique. The 1st phase is to insert the endoscope through the external opening (orifice). In the patients that had more than one opening the lower pit is used for access. The 2nd phase is to identify the sinus cavity and its lateral tracks. The endoscope is advanced along the pathway using slow movements, left/right and up/down. These manoeuvres and the saline solution, used as distension medium, allow the sinus cavity to accommodate the endoscope. Additionally mechanical adhesiolysis with the forceps grasping could be useful. The 3rd phase is to identify the presence of hair and its removal. The 4th phase phase is to obtain complete ablation of sinus cavity. The sinus cavity and its lateral tracks are destroyed with the electrode under continuous direct vision. The 5th phase is to obtain the accurate cleaning of sinus cavity. The saline solution flow allows the elimination of any necrotic material. A Volkmann spoon could be useful to complete the cleaning.
16091930|NCT02222298|Procedure|Bascom Cleft lift procedure|
16091931|NCT02222285|Other|Medical Food : Vayarin_005|
16091932|NCT02222285|Other|Placebo|
16091933|NCT02222259|Procedure|GA and Integrated Care Plan|The intervention will consist of a Geriatric Assessment conducted by a multidisciplinary geriatric oncology team followed by an integrated care plan developed and implemented by the team for those issues identified in the assessment. The study intervention includes contact with the intervention team at 4 points in time during the study: at baseline (to conduct the assessment and develop the integrated care plan), 2-3 weeks by telephone after the clinic visit to evaluate if the plan needs adjustments, at 3 and 6 months (to evaluate the outcomes of the integrated care plan; i.e., did the patient follow all recommendations of the integrated care plan and did the plan lead to the desired outcomes for the problems identified?
16091934|NCT02222246|Drug|Hydromorphone (Standardized, weight-based dosing)|Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).
16091935|NCT02222246|Drug|Morphine Sulfate (Standardized, weight-based dosing)|Standardized analgesic management using a SCD specific standard protocol based on NHBLI guidelines (initial opioid dose weight-based).
16091936|NCT02222246|Drug|Hydromorphone (Patient Specific dosing)|Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.
16091937|NCT02222246|Drug|Morphine Sulfate (Patient Specific dosing)|Patient specific analgesic management, with specific opioid dosage and frequency based on a protocol developed by a patient's healthcare team.
16091938|NCT02222233|Drug|BI 671800 HEA delayed release (enteric coated) tablet|
16091939|NCT02222233|Drug|BI 671800 HEA solution|
16091940|NCT02222233|Drug|BI 671800 HEA particulate|
16091941|NCT02222220|Drug|Metoclopramide|30 mg/day during 4 weeks
16091942|NCT02222220|Drug|placebo|
16091943|NCT02222207|Drug|Regorafenib, ophthalmic oily suspension (BAY73-4506)|Subjects receive Regorafenib as eye drops
16091944|NCT02222207|Procedure|Sham IVT|Sham injections
16091945|NCT02222207|Drug|Ranibizumab|Subjects receive Ranibizumab as intravitreal injection
16091946|NCT02222207|Drug|Placebo|Placebo eye drops
16091947|NCT02222181|Other|Pharmacotherapy Management|"assessment of patient characteristics as alcoholic, smoker, food, drugs
~Pharmacotherapy follow-up
~to evaluated medication adherence
~Assessment of the individual clinical parameters each patient at baseline and after the educational or pharmacy intervention."
16091948|NCT02222168|Drug|BI 409306|medium dose, oral administration
16091949|NCT02222168|Drug|BI 409306|medium dose, oral administration
16091959|NCT02222064|Behavioral|Mindfulness|Mindfulness is a psychological intervention based on increasing skills of non-judgemental awareness using meditations. In this study a self-directed 8 week course of mindfulness will be used involving self-help materials in the form of a book and 8 guided meditations on audio files.
16091960|NCT02222051|Behavioral|Tai Chi|traditional chinese martial art meditative movement technique
16091961|NCT02222051|Behavioral|Neck exercises|group exercises for strengthening and stretching neck and back muslces to alleviate neck pain
16091962|NCT02222038|Other|skin biopsy|
16091963|NCT02222025|Other|Injury Prevention Programme|The injury prevention program will be included at the beginning of the usual football training by replacing the traditional warm-up. The programme will be conducted by the coaches at least two times a week (with exception of school holidays). The prevention programme contains seven exercises and lasts about 15 min after familiarisation. Three exercises focus on unilateral, dynamic stability of the lower extremities (hopping, jumping and landing). Further, three exercises emphasize whole body and trunk stability. The last exercise contains rolling movements to improve fall technique. The difficulty of each exercise can be progressively increased in five steps. Players start at the level of difficulty which corresponds to their current performance level. They will proceed to the next level when they perform the exercises with good control. This will be assessed by the coaches.
16091964|NCT02222012|Device|"single channel Multiway Coil®"|During the single channel treatment trial period the patients will receive the following dose of rTMS: 10 Hz - left DLPFC ( 10 Hz, at 120% MT, 3 sec pulse train, 20 second inter-train interval, 55 trains, i.e. a total of 1650 pulses per session, a total of 20 sessions in the study and a cumulative exposure (total number of pulses) of 33,000pulses in 4 weeks).
16091965|NCT02222012|Device|"Two channels Multiway stimulator coil® (Brainsway Ltd.)"|"During the two channels treatment trial period the patients will receive the following dose of rTMS: 10 Hz- left DLPFC, 1Hz - right DLPFC together.
~10 Hz protocol: ( 10 Hz, at 120% MT, 3 sec pulse train, 20 second inter-train interval, 55 trains, i.e. a total of 1650 pulses per session, a total of 20 sessions in the study and a cumulative exposure (total number of pulses) of 33,000pulses in 4 weeks)
~1 Hz protocol:
~1 Hz, at 120% MT, 5 min pulse train, 1 min inter-train interval, 6 trains, i.e. a total of 1800 pulses per session, a total of 20 sessions in the study and a cumulative exposure (total number of pulses) of 36,000 pulses in 4 weeks)."
16091966|NCT02221999|Drug|Paclitaxel|
16091967|NCT02221999|Drug|Cisplatin|
16091968|NCT02221999|Drug|Gonadotropin-releasing hormone agonist|Goserelin 3.6 mg q28d or Leuprolide 11.25 mg q3m
16091969|NCT02221999|Drug|Letrozole|
16091970|NCT02221986|Behavioral|Interdisciplinary rehabilitation|
16091971|NCT02221973|Dietary Supplement|sterols and hawthorn powder|there are two dose level of sterols (1.2g/d; 1/8g/d)
16091972|NCT02221960|Biological|MEDI6383|Subjects will receive MEDI6383 until disease progression or adverse event.
16091973|NCT02221960|Biological|MEDI6383 and MEDI4736|Subjects will recieve MEDI6383 and MEDI4736 until disease progression or adverse event.
16091974|NCT02221947|Drug|Bryostatin 1|25 μg/m2 bryostatin 1, single dose via intravenous infusion over 1 hour.
16091975|NCT02221947|Drug|Placebo|Placebo, single dose via intravenous infusion over 1 hour.
16091976|NCT02221934|Device|Altius|Electrical signal
16091977|NCT02221921|Device|MicroPort's Transcatheter Aortic Valve and Delivery System|
16091978|NCT02221908|Device|Mespere Venus 1000 CVP System|
16091979|NCT02221895|Other|Postpartum follow up appointment 2-3 weeks after delivery|experimental arm
16091980|NCT02221895|Other|Postpartum follow up 6-8wk after delivery|control arm
16091981|NCT02221882|Drug|LY3164530|Administered IV.
16091982|NCT02221869|Drug|Xyrem|
16091983|NCT02221856|Procedure|Motion View|Motion View, a software we are using to place brackets virtually on a 3D rendition of a patients teeth, will be used to indirectly bond brackets onto patient's teeth with a 3D printed plastic transfer JIG in which the brackets will be precisely placed on the patients teeth according to the computer-guided software.
16091984|NCT02221856|Procedure|Conventional Orthodontic Treatment|orthodontic treatment using non-customized brackets and stock wires
16091985|NCT02221830|Drug|Oxytocin|Our intervention simply replaces the standardly given normal saline with treatment (normal saline + oxytocin)
16091986|NCT02221830|Drug|Placebo|This intervention utilizes a Placebo Camparator
16091989|NCT02221804|Behavioral|14 days of voluntary step count reduction to no more than 1500 steps/day.|
16091990|NCT02221791|Dietary Supplement|Pure Epicatechin|Participants will consume 100mg of epicatechin (capsule) + 70g white chocolate
16091991|NCT02221791|Dietary Supplement|High flavan-3-ol cocoa|Participants will consume 70g high flavan-3-ol cocoa (100mg epicatechin) + placebo capsule
16091992|NCT02221791|Dietary Supplement|Placebo|Participants will consume 70g white chocolate + placebo capsules
16091993|NCT02221778|Radiation|SBRT|"SBRT will be prescribed according to the Radiation Therapy Oncology Group (RTOG) 1112 protocol using Mean Liver Dose (MLD) as parameter. MLD will be calculated using Liver minus Gross Tumor Volume (GTV). Prescription dose will follow the scheme below:
~Prescription dose(Gy) / (MLD) (Gy)
~50 / 13
~45 / 15
~40 / 15
~35 / 15.5
~30 / 16
~27.5 / 17
~If the dose constraints cannot be met, prescription will be according to the level immediately bellow.
~Treatment will be delivered in 5 fractions in consecutive working days"
16091994|NCT02221765|Drug|PP1420|Single dose of PP 1420, administered subcutaneously. Dose levels: 8, 16, 32, 64 mg.
16091995|NCT02221765|Drug|Placebo|0.9% (w/v) saline single-dose, administered subcutaneously
16091996|NCT02221752|Dietary Supplement|Ferrous Sulfate + folic acid|Mothers randomized to receive 2 capsules per day: one with iron (300 mg ferrous sulfate [60 mg elemental iron]) and the other with 0.40 mg folic acid from enrollment to delivery.
16091997|NCT02221752|Dietary Supplement|Folic acid|Mothers randomized to receive 2 capsules per day: one with placebo and one with 0.40 mg folic acid from enrollment to delivery.
16091998|NCT02221739|Drug|Ipilimumab|
16091999|NCT02221739|Radiation|Radiotherapy (IMRT or 3-D CRT)|
16092000|NCT02221726|Drug|JNJ-35684-AAA-023: Size 1; small patch|Placebo (matched to Fentanyl transdermal delivery device system [TDDS]) JNJ-35685-AAA-G-023 TDDS, 5.5 centimeter square (cm^2) will be applied vertically to 1 side of the paraspinal region, replicated 3 times, and worn for 72 hours.
16092001|NCT02221726|Drug|JNJ-35684-AAA-023: Size 2; large patch|Placebo (matched to Fentanyl transdermal delivery device system [TDDS]) JNJ-35685-AAA-G-023 TDDS, 44 cm^2 (Size 1; small patch) will be applied vertically to other side of the paraspinal region, replicated 3 times, and worn for 72 hours.
16092002|NCT02221700|Procedure|Massage Therapy|Undergo massage therapy
16092003|NCT02221700|Other|Quality-of-Life Assessment|Ancillary studies
16092004|NCT02221700|Other|Questionnaire Administration|Ancillary studies
16092005|NCT02221687|Dietary Supplement|Synbiotic formula|Standard milk formula enriched with a prebiotic fiber and a probiotic strain
16092006|NCT02221687|Dietary Supplement|Control formula|Standard milk formula without pre and probiotic
16092007|NCT02221674|Drug|Tapentadol|
16092008|NCT02221648|Drug|Placebo|Subjects will be randomization to receive either the study drug or the placebo group.
16092009|NCT02221648|Drug|AbobotulinumtoxinA Treatment|Subjects receive intervention injections with the study drug arbobotulinumtoxinA.
16092010|NCT02221635|Procedure|rTMS + risperidone|Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.5 sessions per week for 4-6 weeks,than 2 sessions per week for 2 months, repeat that for 12 months. Meanwhile,risperidone (2-4 mg) was took orally.
16092011|NCT02221635|Drug|Risperidone|Risperidone (2-4 mg) was took orally.
16092012|NCT02221622|Drug|Allopregnanolone injection (intravenous solution)|Allopregnanolone intravenous infusion
16092013|NCT02221622|Drug|Placebo injection (intravenous solution)|Placebo intravenous infusion
16092014|NCT02221609|Other|Treatment based on Movement System Impairment model|The analysis and modification of daily activities will be performed by identifying and analyzing the patients activities that provoke their symptoms. The patient will be taught on how to correct his posture and limit the movements that increase the amount of stress on the lumbar spine. The prescription of specific exercises is done based on the patient's classification into one of 5 categories of the MSI model. These exercises consist of practicing the movement tests performed at the initial assessment in a corrected form, emphasizing the control of the lumbar spine movement and increasing movement on the adjacent joints. Patients will also advised to repeat the exercises at home at least once a day. 12 treatment sessions are planned for each patient (2 sessions per week during the first 4 weeks and 1 session per week during the last 4 weeks). Each treatment session has an estimated duration of 45-60 minutes. Patients will register their home exercise in an exercise diary.
16092015|NCT02221609|Other|General exercise|The general exercise program consists of 12 treatment sessions with estimated duration between 45-60 minutes per session (2 sessions per week for the first 4 weeks and 1 session per week in last 4 weeks). Each session is also done individually by a trained physical therapist. The patients perform an exercise program that starts with a 5-minutes warm-up followed by stretching exercises. Those stretching exercises address the six directions of lumbar motion and the lower limbs muscles. The patient also performs strengthening exercises of the trunk muscles. Based on correct performance of the exercises, the subject may progress through increased load as tolerated. He is also advised to perform these exercises at home and receive figures of the exercises with written instructions. The exercise program will be adapted according to American College of Sports Medicine recommendations (Garber et al., 2011). Patients will register their home exercise in an exercise diary.
16092016|NCT02221596|Dietary Supplement|vitamin D|50,000IU/wk of vitamin D3
16092017|NCT02221596|Other|aerobic training|7 days of treadmill training during the 13th week of study
16092018|NCT02221583|Drug|Astagraf XL|Two PK profiles will be obtained in each subject. Each subject will receive either Astagraf XL 8mg daily or Prograf® 4mg every 12 hours in combination with MMF 1000mg every 12 hours. A full 24 hour PK profile will be constructed. After at least a one week washout period, the patient will be crossed over to the alternative tacrolimus formulation (Astagraf XL or Prograf®) in combination with MMF 1000mg every 12 hours and the PK profile repeated.
16092019|NCT02221583|Drug|Prograf|Two PK profiles will be obtained in each subject. Each subject will receive either Astagraf XL 8mg daily or Prograf® 4mg every 12 hours in combination with MMF 1000mg every 12 hours. A full 24 hour PK profile will be constructed. After at least a one week washout period, the patient will be crossed over to the alternative tacrolimus formulation (Astagraf XL or Prograf®) in combination with MMF 1000mg every 12 hours and the PK profile repeated.
16092020|NCT02221583|Drug|Mycophenolate mofetil|Two PK profiles will be obtained in each subject. Each subject will receive either Astagraf XL 8mg daily or Prograf® 4mg every 12 hours in combination with MMF 1000mg every 12 hours. A full 24 hour PK profile will be constructed. After at least a one week washout period, the patient will be crossed over to the alternative tacrolimus formulation (Astagraf XL or Prograf®) in combination with MMF 1000mg every 12 hours and the PK profile repeated.
16092021|NCT02221570|Drug|Baclofen|Baclofen, a derivative of gamma-aminobutyric acid, is a muscle relaxant and an antispastic agent. It was introduced in 1966 as a possible treatment for spasticity due to corticospinal tract lesions. Baclofen was also tested with promising results in the treatment of other medical disorders such as cluster headaches, gastroesophageal reflux disease,chronic hiccups and cough.
16092022|NCT02221557|Device|easy-graft (beta-Tricalcium Phosphate)|
16092023|NCT02221544|Device|Low-frequency repetitive Transcranial Magnetic Stimulation|"Participants will receive treatment at a frequency of 3 sessions per week for 4 weeks (12 sessions). In each session patient will receive repetitive Transcranial Magnetic Stimulation using a stimulation frequency of 10 Hz for half an hour.
~The treatment is done by attaching an electromagnetic coil to the scalp using a special hat. Each patient has a personal hat which serves him throughout the entire process. The treatment is performed without anesthesia and patient fully conscious. During the treatment he sits comfortably on a chair, meanwhile the magnetic field passes through the skull into the brain."
16092024|NCT02221544|Device|rTMS maintenance|Same treatment as in rTMS treatment intervention, but only once a week for a month
16092025|NCT02221544|Device|Sham|Participants will receive sham treatment at a frequency of 3 sessions per week for 4 weeks (12 sessions total) for half an hour each session. The treatment is done by attaching an electromagnetic coil to the scalp but without turning on the magnetic field.
16092026|NCT02221544|Device|Sham maintenance|The same as Sham stimuli intervention, but once a week for a month
16092027|NCT02221531|Drug|Carbetocin Short-infusion|Short-infusion of Carbetocin 100 microgram as compared to bolus application of Carbetocin 100 microgram (double dummy method)
16094268|NCT02205385|Procedure|Targeted Muscle Reinnervation|
16092028|NCT02221531|Drug|Carbetocin Bolus application|Carbetocin 100 microgram given intravenously as a bolus application over about 15 seconds
16092029|NCT02221518|Behavioral|Exposure & Response Prevention (EX/RP)|Exposure and Response Prevention (EX/RP) is a type of Cognitive Behavioral Treatment for treating OCD.
16092030|NCT02221505|Drug|LOP628|
16092031|NCT02221492|Drug|plerixafor GZ316455|Pharmaceutical form:vial Route of administration: subcutaneous injection
16092032|NCT02221492|Drug|Filgrastim|Pharmaceutical form:vial Route of administration: subcutaneous injection
16092033|NCT02221479|Drug|plerixafor GZ316455|Pharmaceutical form:vial Route of administration: subcutaneous injection
16092034|NCT02221479|Drug|Filgrastim|Pharmaceutical form:vial Route of administration: subcutaneous injection
16092035|NCT02221453|Drug|Triamcinolone Acetonide|
16092036|NCT02221440|Device|Low flow nasal oxygen|Oxygen will be administered by nasal catheter at a flow rate of 2 L/min. The therapy will continue until after delivery
16092037|NCT02221440|Device|Low flow room air|Sham: oxygen will be administered by nasal catheter at a flow rate of 0 L/min.
16092038|NCT02221427|Other|Dynamic progression curve|Guideline which takes into account the dilatation of the cervix on admission and calculates the expected progression during the active phase of the first stage of labour based on this finding. Labour dystocia in the second stage of labour is diagnosed if lasting longer than two hours and 45 minutes, three hours and 30 minutes for women with epidurals or if the expulsion phase lasts longer than 60 minutes. This guideline is based on the labour progression curve by Zhang.
16092039|NCT02221427|Other|Static labour progression curve (F)|
16092040|NCT02221414|Drug|Linagliptin/Metformin FDC|
16092041|NCT02221414|Drug|Linagliptin|
16092042|NCT02221414|Drug|Metformin|
16092043|NCT02221401|Drug|Linagliptin/Metformin FDC|
16092044|NCT02221401|Drug|Linagliptin|
16092045|NCT02221401|Drug|Metformin|
16092046|NCT02221388|Drug|BI 671800 HEA, 200 mg tablets|
16092047|NCT02221388|Drug|BI 671800 HEA EC, 200 mg tablets|
16092048|NCT02221388|Drug|BI 671800 HEA, 50 mg tablets|
16092049|NCT02221388|Drug|BI 671800 ED, 100 mg capsules|
16092050|NCT02221388|Other|Standard meal|
16092051|NCT02221375|Drug|BHT low|
16092052|NCT02221375|Drug|BHT medium|
16092053|NCT02221375|Drug|BHT high|
16092054|NCT02221375|Drug|BI 54903 XX low|
16092055|NCT02221375|Drug|BI 54903 XX medium 1|
16092056|NCT02221375|Drug|BI 54903 XX medium 2|
16092057|NCT02221375|Drug|BI 54903 XX high|
16092058|NCT02221375|Drug|Ciclesonide|
16092059|NCT02221349|Device|Potassium oxalate|Professionally applied (liquid) and self applied (gel)
16092060|NCT02221349|Drug|Sodium fluoride paste|Toothpaste used by subject
16092061|NCT02221349|Drug|Stannous fluoride paste|Toothpaste used by subject
16092062|NCT02221336|Device|The MONARCA II system|Daily electronic monitoring of subjective and objective smartphone measures including a feedback loop
16092063|NCT02221336|Device|Non-MONARCA II system|Daily use of smartphone for normal communicative purposes. No self-monitoring in the MONARCA II system.
16092064|NCT02221323|Drug|Insulin LISPRO|
16092065|NCT02221310|Drug|Gemtuzumab Ozogamicin|Gemtuzumab Ozogamicin 7.5 mg/m^2/dose given IV over 2 hours once during conditioning
16092066|NCT02221297|Dietary Supplement|Supplement product with plant stanol ester|2 grams plant stanols consumed with a meal daily for 3 to 4 weeks
16092067|NCT02221284|Drug|Alogliptin|Alogliptin tablets
16092068|NCT02221271|Drug|NPB-01|
16092069|NCT02221258|Biological|FURESTEM-RA Inj.|Patients will be treated FURESTEM-RA Inj.+DMARDs(Disease-Modifying antirheumatic drugs)
16092070|NCT02221245|Procedure|Tumor Biopsy via Ultrasound Endoscopy|The staging ultrasound endoscopy is performed on patients previously diagnosed with esophageal cancer via diagnostic biopsy. The staging ultrasound identifies affected lymph nodes and depth of tumor to the esophageal wall. The tumor sampling is via a biopsy forcep (one pass to obtain 100 cells).
16092071|NCT02221232|Drug|Chloraprep|Apply topically.
16092072|NCT02221232|Drug|ZuraPrep|Apply topically.
16092073|NCT02221232|Drug|ZuraPrep Vehicle|Apply topically.
16092074|NCT02221219|Drug|Indomethacin|indomethacin at standard dose for prevention of intraventricular hemorrhage in preterm infants
16092075|NCT02221219|Procedure|delay in umbilical cord clamp at birth|provision of a ~45 second delay of umbilical cord clamping at birth in preterm infants (recorded in delivery note)
16092076|NCT02221219|Drug|placebo infusion|saline infusion to match input of indomethacin treatment group (and serve as drug-dosing 'blinding' for bedside staff)
16092077|NCT02221219|Procedure|immediate cord clamp at birth|no delay in umbilical cord clamp; <10sec (recorded in delivery note)
16092078|NCT02221206|Device|Mini-Screw implant|Mini-screw implants (VectorTASTM8*1.4mm, Ormco Corporation, USA) were placed between maxillary first molar and second molar after local anesthetic on both sides
16092079|NCT02221193|Other|traditional mouth rinsing and site-specific mouth rinsing (crossover)|blinded prospective, descriptive correlational crossover cross-section clinical trial conduct during the month of Ramadan in the lunar Hajri year 1434 AH (10 July 2013-8 August 2013) in Albaha province in Saudi Arabia involving the application of Listerine® Cool Mint® mouth rinse by either the traditional panoral rinsing method or a site-specific disinfection method targeting the subgingival and supragingival plaque and the posterior third of the tongue dorsum while avoiding the remaining locations within the oral cavity
16092080|NCT02221180|Drug|Canagliflozin and Metformin Immediate Release (IR) Fixed Dose Combination [FDC]|Participants will receive 1 IR FDC tablet containing canagliflozin 150 mg and metformin 500 mg orally under fed or fasted condition in each treatment period as per treatment sequence.
16092081|NCT02221180|Drug|Canagliflozin|Participants will receive canagliflozin 150 mg (50 mg+100 mg oral tablet) under fed or fasted condition in each treatment period as per treatment sequence.
16092082|NCT02221180|Drug|Metformin|Participants will receive metformin 500 mg tablet orally under fed or fasted condition in each treatment period as per treatment sequence.
16092083|NCT02221167|Other|Donor Milk|"breastfeeding plus 10 ml of donor milk by syringe after each breastfeeding until mother's milk comes in."
16092084|NCT02221154|Dietary Supplement|Inofolic®|
16094269|NCT02205385|Procedure|Traction Neurectomy|
16092085|NCT02221154|Other|Gonadotropins; Folic Acid|standard ovarian stimulation
16092086|NCT02221115|Device|Google Glass|The device is a wearable, voice-controlled Android device that resembles a pair of eyeglasses and displays information directly in the user's field of vision
16092087|NCT02221102|Drug|Aspirin|non-steroidal anti-inflammatory drugs
16092088|NCT02221102|Drug|edoxaban|orally active direct factor Xa inhibitor
16092089|NCT02221102|Drug|placebo|
16092090|NCT02221089|Drug|Escherichia coli Endotoxin|dose: 2 ng/kg bodyweight (corresponding to 20 IU/kg), i.v. bolus on both study days.
16092091|NCT02221089|Dietary Supplement|Retaron®|Dosage 1 capsule Retaron® per day.: Lutein 10mg, Zeaxanthin 2mg, Fishoil 500mg (with 250 mg DHA, 30 mg EPA), Vitamin C 100mg, Zinc 10mg, Selen 25µg, Vitamin E 25mg, Taurin 50mg, Aroniaextract 50mg, administered for 14 days
16092092|NCT02221089|Other|Placebo|Placebo capsules identical in appearance to Retaron capsules
16092093|NCT02221076|Device|Confocal Laser Endomicroscopy (CLE)|Real-time microscopic imaging of living tissue during the standard procedure
16092094|NCT02221063|Other|Thiamin fortified fish sauce (low concentration)|Low concentration thiamin fortified fish sauce will be consumed ad libitum for 6 months, with biweekly monitoring and evaluation to assess fish sauce usage by household and to re-stock fish sauce within the home.
16092095|NCT02221063|Other|Thiamin fortified fish sauce (higher concentration)|Higher concentration thiamin fortified fish sauce will be consumed ad libitum for 6 months, with biweekly monitoring and evaluation to assess fish sauce usage by household and to re-stock fish sauce within the home.
16092096|NCT02221063|Other|Placebo fish sauce|Fish sauce fortified only with iron, not thiamin, will be consumed ad libitum for 6 months, with biweekly monitoring and evaluation to assess fish sauce usage by household and to re-stock fish sauce within the home.
16092097|NCT02221037|Drug|GSK2862277|"It is available as 26 milligrams (mg) white to off-white, uniform lyophilized cake that will be reconstituted (using reconstitution fluid formulated with polysorbate 80 in Water for Injection) to 40 mg/vial of Lyophile for reconstitution for inhalation with duration of nebulisation as approximately 3-5 min and will be administered using Pari eFlow with s30 mesh device."
16092098|NCT02221037|Drug|Placebo|"It is a clear, colorless to pale yellow liquid, will be administered in volume to match active dose as solution for inhalation with duration of nebulisation as approximately 3-5 min and will be administered using Pari eFlow with s30 mesh device."
16092099|NCT02221024|Procedure|Flushing with positive pressure|Placement of a sterile plug (MicroClave ICU Medica, a neutral displacement connector) on the needle cannula and flushing with positive pressure with saline solution (BD PosiFlush XS Syringes, filled with 3 ml of saline)
16092100|NCT02221024|Drug|Normal saline|
16092101|NCT02221024|Device|MicroClave ICU Medica|
16092102|NCT02221011|Device|Shock wave|"Shock waves are defined a sequence of acoustic pulse characterized by a high peak pressure (100 MPa), fast pressure rise (< 10 ns) and short duration (10 μs) is conveyed by an appropriate generator to a specific target area with an energy density in the range of 0.003-0.890 mJ/mm2.
~Different studies and clinical experiments have demonstrated the efficacy of shock waves in the treatment of musculoskeletal system such as chronic tendinopathies, calcific tendinitis of the shoulder, lateral epicondylitis, plantar fasciitis, and several tendon diseases."
16092103|NCT02220998|Drug|SOF/VEL|SOF/VEL (400/100 mg) FDC tablet administered orally once daily
16092104|NCT02220998|Drug|SOF|SOF 400 mg tablet administered orally once daily
16092105|NCT02220998|Drug|RBV|RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16092106|NCT02220985|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic HSCT
16092107|NCT02220985|Drug|Cyclophosphamide|Given IV
16092108|NCT02220985|Drug|Fludarabine Phosphate|Given IV
16092109|NCT02220985|Other|Laboratory Biomarker Analysis|Correlative studies
16092110|NCT02220985|Drug|Methotrexate|Given IV
16092111|NCT02220985|Drug|Mycophenolate Mofetil|Given IV and PO
16092112|NCT02220985|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo PBSCT with GCSF-mobilized CD34-enriched PBSC
16092113|NCT02220985|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo PBSCT with CD45RA-depleted cells
16092114|NCT02220985|Drug|Tacrolimus|Given IV or PO
16092115|NCT02220985|Drug|Thiotepa|Given IV
16092116|NCT02220985|Radiation|Total-Body Irradiation|Undergo TBI
16092117|NCT02220972|Drug|Perampanel|
16092118|NCT02220972|Drug|Placebo|
16092119|NCT02220959|Other|walk test|patients will be encouraged to walk a 60 meter distance under 1 minute and FVC will be measured before and after the walk test
16092120|NCT02220946|Device|Vaginal Electrical Stimulation|A vaginal probe inserted, and a medium frequency (50 Hz) alternating current was administered for 5 seconds on, 5 seconds off. the intensity of the current was started at 0 mA, and gradually increased until pelvic muscle contractions was observed, then increased according to patient tolerance. each patient received a 20 minute session once a week for total 8 session
16092121|NCT02220933|Drug|MD1003 100mg capsule|
16092122|NCT02220933|Drug|Placebo|
16092123|NCT02220920|Drug|Canagliflozin (TA-7284)|The patients will receive Canagliflozin orally for 16 weeks
16092124|NCT02220920|Drug|Placebo|The patients will receive Placebo orally for 16 weeks
16092125|NCT02220920|Drug|Insulin|
16092126|NCT02220907|Drug|Teneligliptin/Canagliflozin|Co-administration of Teneligliptin and Canagliflozin orally once daily for 52 weeks.
16092127|NCT02220894|Biological|pembrolizumab|
16092128|NCT02220894|Drug|carboplatin|
16092129|NCT02220894|Drug|paclitaxel|
16092130|NCT02220894|Drug|pemetrexed|
16092131|NCT02220881|Device|Mold making silicone toe separator|Each subject in the controlled receives the custom-made mold making silicone toe separator made by certified orthotist and the recommendation of use the proper shoes without determination of current drug use
16092132|NCT02220881|Other|Observation|The participants in this groups will be educated on how to care the hallux valgus without any intervention. The follow up will be on the 3rd, 6th, 9th and 12th month.
16092133|NCT02220868|Drug|Sofosbuvir, Ribavirin, and Stribild|
16092134|NCT02220855|Drug|BKM120|
16092439|NCT02218515|Procedure|Open Flap Debridement|Open Flap Debridement (Control Group)
16092135|NCT02220842|Drug|Atezolizumab|During safety evaluation stage, atezolizumab will be administered as 1200 milligrams (mg) intravenous (IV) infusion. During expansion stage, atezolizumab will be administered as either 1200 mg IV infusion or at dose decided from safety evaluation stage.
16092136|NCT02220842|Drug|Obinutuzumab|During safety evaluation stage, obinutuzumab will be administered as 1000 mg IV infusion. During expansion stage, obinutuzumab will be administered as either 1000 mg IV infusion or at dose decided from safety evaluation stage.
16092137|NCT02220842|Drug|Tazemetostat|Tazemetostat 800 mg will be administered orally, twice daily, on Days 1 to 21.
16092138|NCT02220829|Drug|Preventive administration of Rapaflo|Rapaflo treatment: 8 mg daily during 4 months and 8 mg every other day for 2 months.
16092139|NCT02220829|Drug|Standard Care|Administration of alpha-blocker Rapaflo only at onset of symptoms.
16092140|NCT02220816|Behavioral|Competitive training|30 sessions of competitive cognitive training; 3 - 5 sessions/week; duration 45 min
16092141|NCT02220816|Behavioral|Non-Competitive Training|30 sessions of non-competitive cognitive training; 3 - 5 sessions/week; duration 45 min
16092142|NCT02220803|Drug|Acetazolamide|Acetazolamide, 250mg tablets, will be administrated as multiple doses. Dosing of acetazolamide will be up-titrated during 3 days according to manufacturer instruction and titration scheme of the study. Maximum daily dosage is 750 mg (equivalent of 3 tablets/daily). Evening medication should be taken 2 hours before bedtime. The total length of Acetazolamide treatment will be 4 weeks (2x2) including 3 days of titration phase of the drug.
16092143|NCT02220803|Device|nasal Continuous Positive Airway Pressure (nCPAP)|
16092144|NCT02220777|Drug|ASP8477|oral
16092145|NCT02220777|Drug|omeprazole|oral
16092146|NCT02220777|Drug|Placebo|oral
16092147|NCT02220764|Device|Teeth abutment|
16092148|NCT02220764|Device|Implant abutments|
16092149|NCT02220751|Drug|non-surgical periodontal therapy + systemic doxycycline|"A program of plaque control with dental prophylaxis and oral hygiene instruction, and the scaling and root planning sessions were included in the non-surgical periodontal therapy. The scaling and root planning was performed by the same operator using curettes and an ultrasonic device, and it was inspected for a second operator. Oral hygiene was reviewed after a week and after a month of periodontal disinfection, followed by dental prophylaxis.
~Non-surgical periodontal therapy was associated with systemic doxycycline 100 mg/day, for two weeks after an initial dose of 200 mg, started on the day before the first scaling and root planning session. Patients of the PD group had no access to information about antibiotics administration to patients of the PD+DM group."
16092150|NCT02220751|Procedure|Non-surgical periodontal therapy|A program of plaque control with dental prophylaxis and oral hygiene instruction, and the scaling and root planning sessions were included in the non-surgical periodontal therapy. The scaling and root planning was performed by the same operator using curettes and an ultrasonic device, and it was inspected for a second operator. Oral hygiene was reviewed after a week and after a month of periodontal disinfection, followed by dental prophylaxis.
16092151|NCT02220738|Drug|ABT-957|ABT-957 administered twice-daily for 7 days
16092152|NCT02220738|Other|Placebo for ABT-957|Placebo for ABT-957 administered twice-daily for 7 days
16092153|NCT02220725|Biological|Andexanet|
16092154|NCT02220725|Other|Placebo|
16092155|NCT02220712|Drug|OPC-14597 IMD|Administration by injection into the deltoid muscle for a total of 5 doses of 400 mg in 4-week intervals
16092156|NCT02220686|Behavioral|Offer and Report Protocol|Physician advice to stop smoking, referral to state Quitline, and physician considers prescribing nicotine replacement therapy.
16092157|NCT02220673|Drug|BHT 0.1%|
16092158|NCT02220673|Drug|BHT 0.5%|
16092159|NCT02220673|Drug|Placebo for RMT-B|
16092160|NCT02220673|Drug|Placebo for HFA-MDI|
16092161|NCT02220660|Drug|BI 1744 CL|
16092162|NCT02220660|Drug|BI 54903 XX|
16092163|NCT02220660|Drug|BI 1744 CL + BI 54903 XX FDC|
16092164|NCT02220660|Drug|Placebo|
16092165|NCT02220647|Drug|Linagliptin/Metformin FDC|
16092166|NCT02220647|Drug|Linagliptin|
16092167|NCT02220647|Drug|Metformin|
16092168|NCT02220634|Drug|Regadenoson|Injection for intravenous administration
16092169|NCT02220621|Device|Crosslinked hyaluronic acid gel|After hysteroscopic adhesiolysis, MateRegen Gel IU is applied into the uterine cavity together with a Foley balloon catheter.
16092170|NCT02220621|Device|Foleys balloon catheter|After adhesivolysis, the Foleys balloon catheter is inserted into the uterine cavityand expanded with normal saline.
16092171|NCT02220608|Biological|Bortezomib|
16092172|NCT02220608|Drug|G-CSF|
16092173|NCT02220595|Procedure|Carotid endarterectomy vs. carotid stenting|
16092174|NCT02220582|Other|MRI|Magnetic Resonance Imaging
16092175|NCT02220556|Procedure|Blood sampling|
16092176|NCT02220543|Other|Back on Track intervention|Biopsychosocial primary care intervention based on multidisciplinary pain rehabiliation programs. The Back on Track intervention comprises 4 individual sessions and 8 group sessions.
16092177|NCT02220543|Other|Primary care as usual|Regular physical therapy in primary care. Physical therapists are recommended by their profession (the Royal Dutch Society for Physical Therapy) to work according to a profession-specific guideline for the treatment of patients with low back pain in primary care settings. Maximally 12 individual sessions (30 minutes each) for a maximum of 8 weeks.
16092178|NCT02220530|Drug|Conscious sedation with iv midazolam and fentanyl.|Sedation group: Conscious sedation with iv midazolam and fentanyl dosed according to age, weight and baseline conditions of the patients.
16092179|NCT02220517|Device|MR-guided in-bore prostate biopsy|Patients of arm A receive a targeted MR-guided in-bore prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MRI two targeted biopsy cores will be taken.
16092180|NCT02220517|Device|MRI/US fusion-guided prostate biopsy|Patients of arm B receive a targeted MRI/US fusion-guided prostate biopsy. From each prostate lesion defined in the diagnostic multiparametric MRI two targeted biopsy cores will be taken. Immediately after targeted biopsy patients undergo additional systematic TRUS-guided biopsy (12 biopsy cores)
16092181|NCT02220504|Other|Antipsychotic treatment discontinuation|Withdrawal of antipsychotic medication to stabilized patients.
16092182|NCT02220504|Other|Maintenance antipsychotic treatment|Maintenance antipsychotic medication to stabilized patients.
16092183|NCT02220491|Radiation|Single-fraction radiotherapy|Volumetric modulated arc therapy (VMAT) delivering 15 Gy in one fraction to brain metastases
16092184|NCT02220491|Radiation|Whole-brain radiotherapy|Whole brain radiotherapy delivering 20 Gy in five fractions to brain metastases
16092185|NCT02220478|Device|Posterior Lateral Approach Total Hip Arthroplasty|All patients enrolled in the study are indicated for a total hip replacement, and will receive this replacement from the surgeon via a Posterior Lateral surgical approach.
16092186|NCT02220465|Behavioral|PA+ Smoking Cessation (LMPA)|
16092187|NCT02220465|Behavioral|Standard Care Smoking Counseling (SCC)|
16092188|NCT02220452|Other|music listening during anesthesia|In patients allocated to the music listening group, audiotapes will be placed on patients' ears, playing soothing and relaxing music throughout anesthesia
16092189|NCT02220452|Other|absence of music listening during anesthesia|In patients allocated to absence of music listening group, audiotapes will be placed on the patients' ears, without however playing any music
16092190|NCT02220426|Drug|Xenon|Inhalation of hyperpolarized xenon gas
16092191|NCT02220400|Drug|Ketamine|
16092192|NCT02220387|Other|exposure to respirable silica dust|History of exposure to respirable silica dust due to job
16092193|NCT02220387|Other|exposure to polycyclic aromatic hydrocarbons exhaust|history of exposure to polycyclic aromatic hydrocarbons exhaust due to job
16092194|NCT02220374|Other|Supportive Finger Tape|Dorsally applied elasticated tape may or may not improve the kinetics of the PIPJ and therefore reduce pain as well as improve function
16092195|NCT02220361|Drug|placebo|received 20 ml intravenous physiological saline The infusion were completed in 30 minutes.
16092196|NCT02220361|Drug|low dose dexmedetomidine|received 0.5μgkg-1 intravenous dexmedetomidine (Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) diluted to 20ml with physiological saline The infusion were completed in 30 minutes.
16092197|NCT02220361|Drug|high dose dexmedetomidine|"received 1μgkg-1 intravenous dexmedetomidine (Jiang Su Heng Rui Medicine Co. Ltd, Jiangsu Province, China) diluted to 20ml with physiological saline.
~The infusion was completed in 30 minutes"
16092198|NCT02220348|Drug|linaclotide|
16092199|NCT02220335|Procedure|Pulmonary arterial denervation|Contrast pulmonary artery （PA) angiography was performed to localize the pulmonary artery bifurcation level and calculate the PA diameter.Once the anatomy was deemed acceptable, the radiofrequency ablation catheter was introduced into the distal bifurcation area of the main PA.This was then maneuvered within the PA to allow energy delivery to ensure that the electrodes were tightly in contact with the endovascular surface. About two to three ablations at 1-15 W for 240 seconds each point were performed in the distal bifurcation area of the main PA.
16092200|NCT02220335|Drug|Standard treatment|Patients in the standard treatment group will take their baseline anti-heart failure medications at the original doses, without any changes except when medically required.The anti-heart failure drugs treatment is consistent in both arms.Patients in the standard treatment group will take one or combination of the following target drugs: endothelin receptor antagonist, 5'-PDE and prostacyclin. On the other hand, patients in the PADN group do not take any of the target drugs mentioned above.
16092201|NCT02220309|Drug|Pramipexole Oral Tablet|Pramipexole is an oral Dopamine agonist.
16092202|NCT02220296|Drug|Insulin 338|Healthy subjects will receive a single dose of insulin 338 in ascending doses. Injected subcutaneously (under the skin).
16092203|NCT02220296|Drug|placebo|Healthy subjects will receive a single dose of placebo. Injected subcutaneously (under the skin).
16092204|NCT02220296|Drug|Insulin 338|Subjects with type 1 DM will receive a single dose of insulin 338 in ascending doses. Injected subcutaneously (under the skin).
16092205|NCT02220296|Drug|insulin glargine|Subjects with type 1 DM will receive 0.4 U/kg insulin glargine once daily for 4 days. Injected subcutaneously (under the skin).
16092206|NCT02220270|Device|ASD and PDA closure|
16092207|NCT02220244|Drug|MD1003 100mg capsule|
16092208|NCT02220231|Procedure|capnothorax|After patient positioning, the capnothorax will be created by insufflation of carbon dioxide in patients undergoing video-assisted thoracoscopic extended thymectomy.
16092209|NCT02220218|Drug|Canagliflozin + Metformin Immediate Release (IR) Fixed Dose Combination (FDC)|Canagliflozin and metformin IR FDC tablet 50 mg/500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.
16092210|NCT02220218|Drug|Canagliflozin|Canagliflozin tablet 50 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.
16092211|NCT02220218|Drug|Metformin IR|Metformin IR tablet 500 mg orally under fed or fasted conditions on Day 1 of any of the 4 treatment periods.
16092212|NCT02220205|Other|PelvicSim|
16092213|NCT02220205|Device|Manufacturer model|
16092214|NCT02220192|Procedure|Focal LEEP|Focal LEEP may or may not cause less damage to the cervix versus standard LEEP. This could potentially be an advantage by avoiding future complications during pregnancy.
16092215|NCT02220179|Behavioral|The Resilience Program|Se the CONSORT trial protocol at http://myresilience.org/ at the subsite 'about us'
16092216|NCT02220166|Dietary Supplement|Triticum monococcum|
16092217|NCT02220153|Biological|UCB7665 Intravenous 1|"Active substance: UCB7665
~Pharmaceutical form: solution
~Concentration: 140 mg/mL
~Route of Administration: intravenous infusion"
16092218|NCT02220153|Biological|UCB7665 Intravenous 2|"Active substance: UCB7665
~Pharmaceutical form: solution
~Concentration: 140 mg/mL
~Route of Administration: intravenous infusion"
16092219|NCT02220153|Biological|UCB7665 Intravenous 3|"Active substance: UCB7665
~Pharmaceutical form: solution
~Concentration: 140 mg/mL
~Route of Administration: intravenous infusion"
16092220|NCT02220153|Biological|UCB7665 Intravenous 4|"Active substance: UCB7665
~Pharmaceutical form: solution
~Concentration: 140 mg/mL
~Route of Administration: intravenous infusion"
16092221|NCT02220153|Biological|UCB7665 Intravenous 5|"Active substance: UCB7665
~Pharmaceutical form: solution
~Concentration: 140 mg/mL
~Route of Administration: intravenous infusion"
16092222|NCT02220153|Biological|UCB7665 Subcutaneous 1|"Active substance: UCB7665
~Pharmaceutical form: solution
~Concentration: 140 mg/mL
~Route of Administration: subcutaneous infusion"
16092223|NCT02220153|Biological|UCB7665 Subcutaneous 2|"Active substance: UCB7665
~Pharmaceutical form: solution
~Concentration: 140 mg/mL
~Route of Administration: subcutaneous infusion"
16093925|NCT02207829|Drug|Tiotropium|Tiotropium 18 mcg once daily in the morning via HANDIHALER inhaler
16092224|NCT02220153|Biological|Intravenous Placebo|"Active substance: Placebo
~Pharmaceutical form: solution
~Concentration: 0.9 % saline
~Route of Administration: intravenous infusion"
16092225|NCT02220153|Biological|Subcutaneous Placebo|"Active substance: Placebo
~Pharmaceutical form: solution
~Concentration: 0.9 % saline
~Route of Administration: subcutaneous infusion"
16092226|NCT02220140|Behavioral|The Resilience Program|See the CONSORT trial protocol at http://myresilience.org/ at the subsite 'about us'.
16092227|NCT02220127|Radiation|GKR with a single shot of the 8 mm collimator|Gamma Knife Radiosurgery (GKR) with a single shot of the 8 mm collimator at an isodose above 90%.
16092228|NCT02220127|Radiation|GKR with a single shot of the 4 mm collimator|Gamma Knife Radiosurgery (GKR) with a single shot of the 4 mm collimator at an isodose between the 40% and 90%.
16092229|NCT02220114|Drug|Vigabatrin: Vigabatrin new ST formulation then Sabril®|"first treatment phase (V1/D1-V3/D84), in which patients already under Sabril® granules for oral solution and naive patients start the new ST formulation; patients already under Sabril® will start at the same dose and regimen as their usual Sabril®. Dose and regimen for naive patients will be chosen according to SPC.
~second treatment phase (V3/D84-V4/D98) in which the patient is switched to Sabril® granules for oral solution (supplied by sponsor) for 15 days at the same dose as under the new ST formulation.
~Dose and treatment regimen should be maintained as in first treatment phase.
~- At V4/D98, patients who received Sabril® granules for oral solution (supplied by sponsor) continue with marketed Sabril® treatment (or switches to another AED, according to the natural evolution of the patient's condition and upon investigator decision)."
16092230|NCT02220088|Procedure|TAI of FOLFOX|Retreatment with TAI: administration of Oxaliplatin , fluorouracil, and leucovorin via the tumor feeding arteries
16092231|NCT02220088|Drug|Sorafenib|Accept sorafenib.
16092232|NCT02220062|Procedure|EUS-CPN|After initially identifying the celiac trunk on endoscopic ultrasound, each injection of 5~10cc ethanol would be performed as bilateral injections at the celiac trunk.
16092233|NCT02220062|Procedure|EUS-CGN|First, identify celiac ganglia. If the celiac ganglia are visualized under linear EUS, the injection of 2~3cc ethanol are applied directly into the each ganglia. If the ganglia are not identified by EUS, bilateral EUS-CPN would be performed
16092234|NCT02220049|Drug|Bortezomib|
16092235|NCT02220036|Dietary Supplement|Magnesium Oxide|Patients aged more than 18 years old with diabetic nephropathy having Fasting Blood Sugar more than 126 mg/dL and proteinuria 30-300 mg/dL (microalbuminuria) and Glomerular Filtration Rate more than 90 mL/min will be chosen. Patient group will receive magnesium supplement (250 milligram) and the other group will receive placebo which is similar to the magnesium tablets in color, odor and appearance both for 12 weeks. All subjects will complete 4 physical activity and 4 dietary records. Outcome measurements including metabolic, renal and inflammatory profiles will be measured at the beginning and end of the study as well as anthropometric measurements.
16092236|NCT02220023|Drug|INOmax Inhalation|
16092237|NCT02220010|Device|Pancreatic stent|The plastic stent is introduced in the pancreatic duct by a duodenoscope
16092238|NCT02219997|Device|Clear clip-on glasses|Clip-on glasses with no blue light filtering properties used as a placebo
16092239|NCT02219997|Device|Blue light filter clip-on glasses|Clip-on glasses with blue light filtering properties similar to ACRYSOF® IOLs
16092240|NCT02219997|Device|ACRYSOF® IQ IOL|AcrySof IQ Aspheric Natural IOL Model SN60WF with UV and blue light filtering properties, previously implanted
16092241|NCT02219997|Device|Clear IOL|Clear IOL, previously implanted
16092242|NCT02219984|Drug|Anticoagulants|
16092243|NCT02219971|Drug|Kukoamine B Mesilate|Kukoamine B Mesilate or placebo single-dose and intravenous(IV) drip for 1 hour in healthy volunteers.
16092244|NCT02219945|Other|5 min exhaled breath sampling with soft nose clamp|study participants are requested to quietly sit and allow exhaled breath to be sampled through mouth piece breathing with nose clamp during 5 min while electronic data are collected in the device and later downloaded on a laptop pc
16092245|NCT02219932|Drug|fampridine|
16092246|NCT02219932|Drug|Placebo|Matched placebo
16092247|NCT02219919|Other|Surgical Group|The surgical group will receive a surgical procedure consisting of the decompression and release of the median nerve at the carpal tunnel performed by an experienced surgeon according to standardized protocols.
16092248|NCT02219919|Other|Physical Therapy Group|The physical therapy group will receive 3 treatment sessions of manual therapy including desensitization maneuvers of the central nervous system of 30 minutes of duration, once per week.
16092249|NCT02219906|Dietary Supplement|Resveratrol|1000mg tid
16092250|NCT02219906|Dietary Supplement|Placebo|1000mg tid placebo
16092251|NCT02219893|Drug|MOC31PE Immunotoxin|Patients who meet inclusion criteria will be treated with a single intraperitoneal MOC31PE immunotoxin instillation for 6 hours on the first day after CRS and HIPEC
16092252|NCT02219880|Dietary Supplement|Kava (240mg of kavalactones per day)|Kava 60 milligrams per tablet = 240mg of kavalactones per day
16092253|NCT02219880|Dietary Supplement|Placebo|Inert tablets containing vegetable fibre matched for colour, size and consistency to active arm treatment.
16092254|NCT02219867|Drug|Ketamine|Drug (including placebo)
16092255|NCT02219854|Procedure|Laparoscopic gastrectomy|
16092256|NCT02219854|Procedure|Open gastrectomy|
16092257|NCT02219841|Procedure|radiofrequency catheter ablation|
16092258|NCT02219828|Drug|Anakinra|2mg/Kg daily sc up to 100mgday as maximum dose
16092259|NCT02219828|Drug|Placebo|Placebo
16092261|NCT02219802|Procedure|Treatment according arm|
16092262|NCT02219789|Drug|Alisertib|Given PO
16092263|NCT02219789|Drug|Fulvestrant|Given IM
16092264|NCT02219789|Other|Laboratory Biomarker Analysis|Correlative studies
16092265|NCT02219776|Drug|Benzoyl Peroxide solution Plus Chlorhexidine Scrub|Subjects will be provided instructions on how to use and apply the chlorhexidine using a scrub brush and 1.5 oz bottle of 10% benzoyl peroxide emollient application
16092266|NCT02219776|Other|Standard of Care - Chlorhexidine Scrub only|Subjects will be given instructions on how to apply the Chlorhexidine using a scrub brush
16092440|NCT02218515|Biological|EmdogainⓇ(Enamel Matrix Derivative)|Open Flap Debridement+Enamel Matrix Derivative
16093971|NCT02207504|Drug|Enzalutamide|Enzalutamide is an androgen receptor signaling inhibitor.
16092267|NCT02219750|Drug|switch twice-daily insulin|"compare two different insuiln regimen in basal insuln base and premixed insulin.
~NovoMix 30, drug class:biphasic insulins Lantus, drug class: long-acting insuiln Levemir, durg class: long-acting insulin NovoRapid, drug class: rapid-acting insulin"
16092268|NCT02219737|Drug|Carboplatin|Given IVPB
16092269|NCT02219737|Drug|Etoposide|Given IVPB
16092270|NCT02219737|Drug|Ibrutinib|Given PO
16092271|NCT02219737|Drug|Ifosfamide|Given IV
16092272|NCT02219737|Other|Laboratory Biomarker Analysis|Correlative studies
16092273|NCT02219737|Other|Pharmacological Study|Correlative studies
16092274|NCT02219737|Biological|Rituximab|Given IV
16092275|NCT02219724|Drug|MOXR0916|MOXR0916 will be administered as intravenous infusion on Day 1 of each 21-day cycle.
16092276|NCT02219711|Drug|MGCD516|MGCD516 is a small molecule inhibitor of several closely related receptor tyrosine kinases. MGCD516 capsules will be taken with water.
16092277|NCT02219698|Drug|Ibuprofen|
16092278|NCT02219698|Drug|Paracetamol|
16092279|NCT02219685|Drug|LDV/SOF|90/400 mg FDC tablet administered orally once daily
16092280|NCT02219685|Drug|Placebo|Tablet administered orally once daily
16092281|NCT02219672|Drug|Triplitode|"Drug: Triptolide Triptolide Wilfordii is a Chinese old herb which is widely used as a remedy for rheumatic diseases and nephropathy in China. It is approved that it can play a role as an immune modular.
~Other Name: Tripterygium Wilfordii Hook F (TwHF) Drug: cART Participants who will be enrolled in this Triplitode group would be treated with Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir ."
16092282|NCT02219672|Drug|Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir|Participants who will be enrolled in this trial would be treated with Tenofovir plus lamivudine plus Lopinavir / ritonavir plus raltegravir.
16092283|NCT02219659|Drug|Sedation Protocol with Daily Interruption|Continuous infusion of fentanyl and midazolam is started and titrated to target pain and RASS score: Fentanyl started at 25 mcg/hr titrated by 25 mcg/hr every 30 minutes to goal pain score; Midazolam started at 1 mg/hr titrated by 1 mg/hr every hour to goal RASS score for the study design duration (28 days) or for the duration of mechanical ventilation. Every morning both infusions are stopped and when the patient is awake and met the SBT safety screen, 120-min CPAP trial is performed. If the patient meets the CPAP passing criteria, arterial blood gas (ABG) is done and the patient is placed back to the previous ventilator setting. ABG result is notified to the physician for determination for extubation. If the patient does not pass the CPAP trial it is repeated next morning.
16092284|NCT02219659|Drug|Sedation Protocol Without Daily Interruption|Continuous infusion of fentanyl and midazolam is started and titrated to target pain and RASS score: Fentanyl started at 25 mcg/hr titrated by 25 mcg/hr every 30 minutes to goal pain score; Midazolam started at 1 mg/hr titrated by 1 mg/hr every hour to goal RASS score for the study design duration (28 days) or for the duration of mechanical ventilation. Every morning when the patient's RASS score is 0 to -2 and the patient passes the SBT safety screen, 120-min CPAP trial is performed. If the patient meets the CPAP passing criteria, arterial blood gas (ABG) is done and the patient is placed back to the previous ventilator setting. ABG result is notified to the physician for determination for extubation. If the patient does not pass the CPAP trial it is repeated next morning.
16092285|NCT02219659|Drug|Fentanyl Push First|Fentanyl 25 mcg intravenous push (IVP) every 5 min up to 4 doses hourly as needed to target pain score for the study design duration (28 days) or for the duration of mechanical ventilation. Every morning when patient's RASS is 0 to -2 and passes the SBT safety screen, 120-min CPAP trial is performed. If patient meets CPAP passing criteria, the physician will be notified for determination of extubation. If patient does not pass, it is repeated next morning. If target RASS is not achieved with fentanyl IV push alone, study team is notified and fentanyl infusion at 50 mcg/hr titrated by 25 mcg/hr every 30 min to target pain score (max 6 hrs). If target RASS score is not achieved with the fentanyl IV, propofol infusion is started at 5 mcg/kg/hr titrated by 5 mcg/kg/hr every 15 min to target RASS score (max 6 hrs).
16092286|NCT02219646|Drug|Vardenafil|Vardenafil 10 mg twice daily for six months
16092287|NCT02219646|Drug|Placebo|Placebo two tablets daily for 6 months
16092288|NCT02219633|Drug|LEO 39652 cream|Applied for 21 days
16092289|NCT02219620|Behavioral|Music, Imagery, Movement|Implementation of music, art and imagery activation, and movement in group modality
16092290|NCT02219620|Behavioral|Social Control|social conversational group facilitated by care counselor
16092291|NCT02219594|Device|CT image for patient with suspected in-stent restenosis|"Gemstone CT or 320-detector row spiral CT was assigned randomly to patient who was suspected in-stent restenosis.About after 10 days,they would accept the check of OCT which wold be the gold standard of in-stent restenosis."
16092292|NCT02219581|Drug|Dexamethasone 10 mg|Two doses of dexamethasone 10 mg will be given intravenously. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.
16092293|NCT02219581|Drug|Dexamethasone 20 mg|Two doses of dexamethasone 20 mg will be given intravenously. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.
16092294|NCT02219581|Drug|Standard multimodal pain management regimen|"The standard multimodal postoperative pain management regimen typically used for total knee arthroplasty consists of the following:
~Preoperative:
~Decadron: 10 or 20mg IV x 1 2 doses, 8 hours apart (if randomized to study group)
~Intraoperative:
~Ropivacaine: Given intraoperatively. Capsule, subcutaneous tissue/skin. Administered in standard fashion. (300mg)
~Toradol: 30mg q 6hr for 6 total doses. 1st dose given intraoperatively at incision. (15 mg if older patient or CrCl low)
~Postoperative
~Tylenol: 1000mg po q 8hr (scheduled)
~Oxycodone: 5mg or 10mg q 3-4hr prn pain, If intolerant to Oxycodone: second agent line is Hydrocodone or Oral Dilaudid
~IV Morphine (or Dilaudid): 1 or 2 mg q 2hr prn breakthrough pain
~Morphine PCA: only for failure of the above
~MS Contin: Use as backup prn pain"
16092295|NCT02219581|Drug|Placebo|Participants in the placebo arm will receive two doses of saline intravenously. The first dose will be given preoperatively within 3 hours of surgery and the second dose will be administered 8 hours after the first dose in the inpatient setting.
16092441|NCT02218515|Biological|EmdogainⓇEnamel Matrix Derivative+Autogenous Bone|Open Flap Debridement+EmdogainⓇ(Enamel Matrix Derivative)+Autogenous Bone
16093038|NCT02214290|Drug|Caffeine|A 200 mg caffeine tablet was given to subject to examine the drugs effect on arterial function.
16092296|NCT02219568|Procedure|CT enterography|CT enterography is performed using 64-channel multi-detector row CT scanners (Siemens Sensation 64, Siemens Medical solution, Forchiem, Germany). Prior to the scan, 1500 cc of a neutral oral-enteric contrast material, polyethylene glycol (NIFLEC) is taken by the patient. During the scan, 2cc/kg of intravenous contrast (iohexol, Ominipaque Amersham GE-Health care, Princeton, NJ) is injected at the velocity 5 cc/sec.
16092297|NCT02219568|Device|video capsule endoscopy|Video capsule endoscopy is performed using PillCam SB (Given Imaging, Yokneam, Israel). Polyethylene glycol (NIFLEC) is used for bowel preparation.
16092298|NCT02219555|Drug|Steroid Injection|volume and specific steroid drug will be based on the recommendation of the treating clinician
16092299|NCT02219555|Procedure|Carpel Tunnel surgery|Standard of care carpel tunnel surgery
16092300|NCT02219542|Drug|transversus abdominis plane block|transversus abdominis plane block with 20 mL saline
16092301|NCT02219542|Drug|transversus abdominis plane block|transversus abdominis plane block with 20 mL 0.25% ropivacaine
16092302|NCT02219529|Device|MCE|
16092303|NCT02219529|Device|Standard gastroscopy|
16092304|NCT02219516|Drug|RDEA3170|
16092305|NCT02219503|Drug|Ombitasvir/Paritaprevir/Ritonavir|Tablet; paritaprevir co-formulated with ritonavir and ombitasvir
16092306|NCT02219503|Drug|Dasabuvir|Tablet
16092307|NCT02219490|Drug|ABT-333|tablet
16092308|NCT02219490|Drug|ABT-450/r/ABT-267|tablet
16092309|NCT02219490|Drug|Ribavirin (RBV)|tablet
16092310|NCT02219477|Drug|ombitasvir/paritaprevir/ritonavir|tablet; paritaprevir co-formulated with ritonavir and ombitasvir
16092311|NCT02219477|Drug|dasabuvir|tablet
16092312|NCT02219477|Drug|ribavirin|tablet
16092313|NCT02219464|Device|Nasopharyngeal catheter|
16092314|NCT02219464|Device|Nasal Cannula|
16092315|NCT02219464|Procedure|Oxygen Supplementation|Initially set at 3 liters/minute
16092316|NCT02219464|Procedure|Sedation|Midazolam 2mg IV, Fentanyl 100mcg IV, Propofol 100 mcg/kg/min. Additional doses of propofol at the discretion of the attending anesthesiologist.
16092317|NCT02219451|Other|exercise training|exercise training
16092318|NCT02219438|Drug|Bolus|An adductor canal catheter was inserted and ropivacaine 0.2% administered as hourly bolus doses of 8 mL each: one at time point zero and then on the hour for 7 additional doses.
16092319|NCT02219438|Drug|Basal|An adductor canal catheter was inserted and ropivacaine 0.2% administered as a continuous basal infusion (8 mL/h) from time point zero for a total of 8 hours.
16092320|NCT02219425|Procedure|endometrial biopsy|
16092321|NCT02219412|Drug|ticagrelor|90 mg bid for 2 weeks
16092322|NCT02219412|Drug|Aspirin|100mg Qd for 2 weeks.
16092323|NCT02219399|Dietary Supplement|600 mg DHA|Pregnant women were given 600 mg DHA in the last trimester of pregnancy
16092324|NCT02219399|Dietary Supplement|300 mg DHA|Pregnant women were given 300 mg DHA in the last trimester of pregnancy and through the first 3 months of breastfeeding
16092325|NCT02219399|Dietary Supplement|Placebo|Pregnant women in the control group received placebo of either olive oil or high oleic acid sunflower oil during the study period
16092326|NCT02219386|Other|Group 1. Deep dry needling|Deep dry needling and stretch. The intervention included DDN of every active MTrP found in the trapezius muscle using a 4 cm x 0.32 mm acupuncture needle as described by Simons et al. (Simons et al., 1999). Once the needle was inserted into the MTrP previously marked by the blinded assessor, local twitch responses (LTRs) were obtained by using Hong's fast-in and fast-out technique, which involves rapid movements of the needle in and out of the MTrP. After four LTRs, the needle was withdrawn and the area was disinfected with alcohol again (Simons et al., 1999). Then, passive stretch was performed on the trapezius muscle.
16092327|NCT02219386|Other|group 2. Passive analitical stretch (performed in both groups)|
16092328|NCT02219373|Drug|Gabapentin|Patients will be randomized to receive either Gabapentin or Oxcarbazepine. The assignment of the medications will be randomized and blinded to both the study investigators and the patient. If patients exhibit >30% pain reduction on receiving the medication evaluated after 4 weeks, then they may continue to receive either the same medication or placebo. If patients exhibit <30% pain reduction, the patient will crossover to the other medication option in the protocol.
16092329|NCT02219373|Drug|Oxcarbazepine|Patients will be randomized to receive either Gabapentin or Oxcarbazepine. The assignment of the medications will be randomized and blinded to both the study investigators and the patient. If patients exhibit >30% pain reduction on receiving the medication evaluated after 4 weeks, then they may continue to receive either the same medication or placebo. If patients exhibit <30% pain reduction, the patient will crossover to the other medication option in the protocol.
16092330|NCT02219373|Other|Placebo|Patients taking placebo will have placebo dose escalated using similar frequency, periods of time, and volumes as those for the active drugs.
16092331|NCT02219347|Drug|DMARD cessation|Complete cessation of non-biologic DMARD therapy (single or combination of methotrexate, sulphasalazine and/or hydroxychloroquine)
16092332|NCT02219334|Device|NoseFrida|The NoseFrida has four components, the collection container, an interchangeable filter, flexible tubing and a mouth piece. The end of the collection devise is placed on the patient's nostril, a tight seal is made via the vacuum created from suctioning of the mouth piece and secretions are easily aspirated. This device disassembles for quick disinfecting and cleaning.
16092333|NCT02219321|Drug|Lidocaine infusion|Lidocaine intravenous 2mg/kg initial bolus over 5 minutes followed by a continuous intravenous infusion of lidocaine at a rate of 2mg /kg /hour for 4 hours
16092334|NCT02219321|Drug|Saline infusion|A continuous intravenous infusion of saline at the same volume with lidocaine infusion for 4 hours
16092335|NCT02219308|Procedure|Paracervical Block (PCB)|"Drug: 1% Lidocaine Hydrochloride
~Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix and 18 mL 1% buffered lidocaine solution evenly distributed between 4 o'clock and 8 o'clock positions of cervix with standard 22 gauge spinal needle.
~IUD placement then proceeds"
16092336|NCT02219308|Procedure|No Paracervical Block (Sham PCB)|"Drug: 1% Lidocaine Hydrochloride
~Injection of 2 mL 1% buffered lidocaine solution at anterior lip of cervix with standard 22 gauge spinal needle. Capped spinal needle is then held against the cervix at 4 o'clock and 8 o'clock positions of cervix, lightly so as not to cause blanching, indentation, or pain.
~IUD placement then proceeds"
16093175|NCT02213289|Drug|Standard cytotherapy|FOLFOX (First Line) +FOLFIRI (Second Line) +FOLTAX (Third Line)
16092337|NCT02219295|Dietary Supplement|sweet block|oral application of the above mentioned substances in 300 ml tap water in 5 min. , collection of blood at 0,15,30, 60 ,120,180 minutes for measurement of incretins GIP(gastrointestinal polypeptide) and GLP-1 (glucagon like peptide 1), Protein hormones PYY(Peptide YY),CCK (cholecystokinin), Leptin and Insulin
16092338|NCT02219295|Dietary Supplement|bitter block|oral application of the above mentioned substances in 300 ml tap water, collection of blood samples at -15,0,15,30,60,120,180 min for Insulin, GIP,GLP-1, PYY and glucose
16092339|NCT02219295|Dietary Supplement|umami-block|oral application of umami substances as glutamate with and without IMP, collection of blood samples as above
16092340|NCT02219295|Other|gastroscopy|gastroscopy with and without oral application of saccharin, tissue samples from th upper duodenum by endoscopy for the detection of taste receptor cells in the upper bowel
16092341|NCT02219282|Other|Laryngeal Mask Unique insertion|Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than three years experience.
16092342|NCT02219256|Drug|TAK-079|TAK-079 solution
16092343|NCT02219256|Drug|Placebo to TAK-079|Placebo to TAK-079 solution
16092344|NCT02219243|Behavioral|Online Interpretation Training Condition 1|The online computerized training is a web-based tool that modifies how children interpret ambiguous scenarios.
16092345|NCT02219243|Behavioral|Online Interpretation Training Condition 2|The online computerized training is a web-based tool that modifies how children interpret ambiguous scenarios.
16092346|NCT02219230|Device|Active knee (Ossur Power Knee II)|Prosthetic knee with active control system.
16092347|NCT02219230|Device|Adaptive knee (Ossur Rheo)|Prosthetic knee with adaptive control system.
16092348|NCT02219230|Device|Passive knee (Various manufacturers)|Prosthetic knee with mechanical control system.
16092349|NCT02219217|Drug|Dolutegravir, Elvitegravir and Cobicistat|
16092350|NCT02219204|Procedure|Acupuncture|
16092351|NCT02219204|Other|Herbal treatment|
16092352|NCT02219191|Drug|puerarin tablet 50 mg|
16092353|NCT02219191|Drug|Atorvastatin tablet 20 mg|Approval No.: H19990258
16092354|NCT02219178|Drug|lenalidomide|25mg days 1 - 14 of 21 day schedule
16092355|NCT02219178|Drug|Subcutaneous bortezomib|1.3mg/m2 days 1, 4, 8, 11 of 21 day schedule
16092356|NCT02219178|Drug|Dexamethasone|20mg on days 1, 2, 4, 5, 8, 9, 11, 12 of 21 day schedule
16092357|NCT02219165|Drug|Intravenous human immunoglobulin|Single administration of IVIG 2 g/kg within the 12 hours following PICU admission (or following the manifestation of the first signs of shock). The bottles of IVIG used will contain 10 g of proteins in 100 ml of solution. Thus, to reach a concentration of 2 g/kg, will be administered 1 bottle per 5 kg of body weight (with a maximum of 14 bottles for 70 kg patients and over).
16092358|NCT02219165|Drug|Albumin|Single administration of albumin 4% within the 12 hours following PICU admission (or following the manifestation of the first signs of shock). The solution will be given at the same volume as IVIG (that is: 1 bottle / 5 kg of body weight).
16092359|NCT02219152|Drug|tranexamic acid|
16092360|NCT02219152|Drug|saline|
16092361|NCT02219139|Device|ESTA abutment Roxolid|Enhanced Soft Tissue Attachment surface on Roxolid or machined surface on Roxolid abutment placement.
16092362|NCT02219126|Other|Dietary intervention|
16092363|NCT02219113|Procedure|Arthroscopic surgery|
16092364|NCT02219113|Procedure|Liposuction|
16092365|NCT02219113|Device|ADRC isolation|ADRC isolation performed using Celution 800/CRS System (Cytori Therapeutics Inc) according to manufacturer's protocol
16092366|NCT02219113|Other|Intraarticular administration of autologous ADRC|
16092367|NCT02219100|Drug|Home administration of 200 mg mifepristone|Home administration of 200 mg mifepristone
16092368|NCT02219087|Drug|Liposomal bupivacaine|
16092369|NCT02219087|Drug|Standard of Care|Pre-operative adductor canal nerve block (20mL of 0.5% ropivacaine). Intra-operative popliteal nerve block from the surgeon: 20mL 0.2% ropivacaine and a peri-articular injection of 10mg morphine, 30mg ketorolac and 40mg methylprednisolone.
16092370|NCT02219074|Device|Sebacia microparticle and laser treatment|
16092371|NCT02219074|Device|Vehicle and laser treatment|
16092372|NCT02219048|Drug|Placebo|680 micrograms BID, Orally inhaled placebo for 12 weeks
16092373|NCT02219048|Drug|PF-03715455|680 micrograms BID, Orally inhaled PF-03715455 for 12 weeks
16092374|NCT02219022|Other|Control group|
16092375|NCT02219022|Other|Experimental group|
16092376|NCT02219009|Device|MIND1 System|Subjects will receive aripiprazole tablets embedded with an IEM. They will discontinue their normally prescribed oral aripiprazole tablets and will take the aripiprazole + IEM tablets (eg, at the previously prescribed dose) during the 8-week treatment period for this study. Aripiprazole + IEM tablets must be taken on a once-daily dosing schedule.
16092378|NCT02218983|Device|Limited Transthoracic Echocardiogram (LTTE, SonoSite Ultrasound)|
16092379|NCT02218983|Other|Usual care|
16092380|NCT02218970|Behavioral|strength training|
16092381|NCT02218970|Behavioral|no training (control)|
16092382|NCT02218957|Procedure|Extended Pouch RYGB|
16092383|NCT02218957|Procedure|Standard RYGB|
16092384|NCT02218944|Behavioral|Response Inhibition Training|The primary purpose of this research is to examine the feasibility and efficacy of a smoking specific response inhibition training program in the context of a quit attempt. The task is based on a modified stop-signal task. The study utilizes a one-way nested design with three conditions.
16092442|NCT02218502|Other|Ultrasound by general gynaecologist|All patients will undergo an ultrasound by a general gynaecologist at the moment of inclusion. Based on this ultrasound, the gynaecologist will use both the RMI and the simple rules to predict the chance of malignancy.
16092443|NCT02218502|Other|Ultrasound by an expert ultrasonographist|Patients in which the simple rules yield an inconclusive result (about 20% of all patients) will undergo a second ultrasound scan. This scan is performed by an expert in gynaecological ultrasound.
16094270|NCT02205372|Drug|MT-3995|
16092385|NCT02218931|Behavioral|Targeted ESTEEM diet|"The key components of the diet are:
~High intake of vegetables, nuts, non-refined grains, legumes and fruits;Moderate to high consumption of fish;Small to moderate intake of poultry and dairy products such as yoghurt and cheese;Low consumption of red meat and processed meat and avoidance of sugary drinks, fast food and high fat food;High fibre;Intake of nuts including walnuts and almonds that are rich sources of monounsaturated and polyunsaturated fatty acids (30 g/day);Olive oil to cook and dress salads as the main source of fat (0.5 l/week)
~The intervention will include structured meal plans and grocery lists, recipes for healthy diet and appropriate choices at restaurants"
16092386|NCT02218931|Other|Non-randomised cohort|Non-randomised cohort of women with no metabolic risk factors will be followed up to delivery to collect outcome data
16092387|NCT02218918|Behavioral|Ground walk training|3 times a week and 6 weeks
16092388|NCT02218918|Behavioral|Supervised Treadmill Walk training|3 times a week and 6 weeks
16092389|NCT02218905|Behavioral|Sit to stand test|Subjects will be asked to sit to stand in 40 inches chair for 60 seconds.
16092390|NCT02218879|Drug|Tecfidera|Oral Tecfidera 240 mg bid
16092391|NCT02218840|Other|Smoking topography|Evaluation of cigar smoking topography
16092392|NCT02218827|Drug|Loteprednol Etabonate (FML)|a steroid topical treatment used for moderate dry eye symptoms. this drug causes less increase in intra ocular pressure
16092393|NCT02218814|Procedure|Adductor Canal Block, Bupivacaine|"Adductor Canal Nerve Block: Under US guidance and sterile technique 30 mL (100 mg) of Bupivacaine is deposited adjacent to the femoral artery and deep to the Sartorius muscle, using intermittent aspiration.
~Femoral Nerve Block: Under US guidance, using a twitch monitor and sterile technique, 30 ml of PF Normal Saline is deposited adjacent to the femoral artery at the level of inguinal crease."
16092394|NCT02218814|Procedure|Femoral Nerve Block, Bupivacaine|"Femoral Nerve Block: Under US guidance, using a twitch monitor and sterile technique, 30 ml (100 mg) of Bupivacaine is deposited adjacent to the femoral artery at the level of inguinal crease.
~Adductor Canal Nerve Block: Under US guidance and sterile technique 30 mL of PF Normal Saline is deposited adjacent to the femoral artery and deep to the Sartorius muscle, using intermittent aspiration."
16092395|NCT02218801|Other|Evaluation of treatment for liver metastasis|
16092396|NCT02218775|Drug|LY2456302|Mood and Anxiety Disorders
16092397|NCT02218762|Drug|Fluticasone Propionate/Salmeterol Xinafoate DISKUS|A blister strip contained within the DISKUS inhaler. Each blister contains a small quantity of powder comprising of a blend of fluticasone propionate (micronized)(100 mcg), salmeterol xinafoate (micronized) (50 mcg) and excipient(s). One blister to be administered twice daily via DISKUS inhaler
16092398|NCT02218762|Drug|Placebo to Match DISKUS|A blister strip contained within the DISKUS inhaler. Each blister contains a small quantity of lactose and powder comprising of excipient(s). One blister to be administered twice daily via DISKUS inhaler
16092399|NCT02218762|Drug|Fluticasone Propionate/Salmeterol Xinafoate ROTACAPS|A capsule containing a small quantity of powder comprising of a blend of fluticasone propionate (micronized) (100 mcg), salmeterol xinafoate (micronized) (50 mcg) and excipient(s). One capsule to be administered twice daily via ROTAHALER inhaler
16092400|NCT02218762|Drug|Placebo to Match ROTACAPS|A capsule containing a small quantity of lactose and powder comprising of excipient(s). One capsule to be administered twice daily via ROTAHALER inhaler
16092401|NCT02218749|Other|Initially triaged to physiotherapist|
16092402|NCT02218749|Other|Initially triaged to physician|
16092403|NCT02218736|Drug|CERC-501|Oral dosing of 10 mg CERC-501 daily for 8 weeks
16092404|NCT02218736|Drug|placebo|oral dosing of 10 mg placebo daily for 8 weeks
16092405|NCT02218723|Drug|FF UD-DPI|A blister containing a small quantity of powder comprising of a blend of FF (micronised) and excipient(s) will be administered using UD-DPI. It is available in following dosages: 80mcg/Blister (0.8% Blend); 100mcg/Blister (0.8% Blend); 140mcg/Blister (0.8% Blend); 100mcg/Blister (0.6% Blend)
16092406|NCT02218723|Drug|FF ELLIPTA DPI|A blister strip contained within the ELLIPTA device. Each blister contains a small quantity of powder comprising of a blend of FF and excipient(s) in dose 100mcg/Blister (0.8% Blend)
16092407|NCT02218697|Biological|Influsplit™ Tetra (Fluarix™ Tetra)|Intramuscular injection, 1 dose each in Control and Co-Ad groups.
16092408|NCT02218697|Biological|Pneumovax™ 23|Intramuscular injection, 1 dose each in Control and Co-Ad groups.
16092409|NCT02218697|Biological|Placebo (Saline)|Intramuscular injection, 1 dose each in Control and Co-Ad groups.
16092410|NCT02218684|Drug|Telmisartan|
16092411|NCT02218684|Drug|Lacidipine|
16092412|NCT02218684|Drug|Placebo|
16092413|NCT02218671|Drug|WE 941 OD tablets|
16092414|NCT02218658|Drug|WE941 OD tablets|
16092415|NCT02218658|Drug|Brotizolam|
16092416|NCT02218645|Drug|WE 941 OD tablets|
16092417|NCT02218645|Drug|Brotizolam|
16092418|NCT02218632|Other|lactose-free diet|standard diet
16092419|NCT02218632|Dietary Supplement|Temporary oral galactose supplements|galactose supplements in the range of physiological galactose production
16092420|NCT02218619|Drug|Tauroursodeoxycholic Acid (TUDCA)|TUDCA at 1750 mg/day x 12 months
16092421|NCT02218619|Drug|Sugar Pill (placebo)|Placebo
16092422|NCT02218606|Drug|Abiraterone acetate 1000 mg po daily|
16092423|NCT02218606|Drug|Cabazitaxel 25 mg/m2 IV|
16092424|NCT02218606|Drug|prednisone 5 mg po BID|
16092425|NCT02218593|Device|WREX orthosis|Upper extremity exoskleton used to assist movement
16092426|NCT02218580|Other|Massage therapy|
16092427|NCT02218580|Other|Standard care|
16092428|NCT02218567|Behavioral|questionnaire qualilty of life|
16092429|NCT02218567|Behavioral|psychological interview|
16092430|NCT02218567|Behavioral|psychological tests|
16092431|NCT02218567|Other|Motor evaluation|
16092432|NCT02218567|Behavioral|Behavioral evaluation|
16092433|NCT02218567|Behavioral|cognitive tests|
16092434|NCT02218554|Genetic|BRONJ|collection of the blood sample from the subject for evaluation of the Micromedic BRONJ Risk Assessment in vitro Diagnostic Assay
16092435|NCT02218541|Device|abutment margin 0.5 mm subgingival|
16092436|NCT02218541|Device|abutment margin 1.5 mm subgingival|
16092437|NCT02218528|Dietary Supplement|Plant-based ingredient|
16092438|NCT02218528|Dietary Supplement|No Plant-based ingredient|
16092444|NCT02218502|Other|DW-MRI|Patients in which the simple rules yield an inconclusive result (about 20% of all patients) will undergo a diffusion weighted MRI.
16092445|NCT02218502|Other|Give blood sample|Patients in which the simple rules yield an inconclusive result (about 20% of the patients) will be asked for an extra blood sample. We will use these materials to perform translational research and validate new biomarkers in the diagnosis of ovarian cancer.
16092446|NCT02218489|Drug|KPI-121|KPI-121 drug product will be supplied in 0.25% strength as a suspension in opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate. Subjects randomized to placebo control arm will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
16092447|NCT02218489|Drug|Vehicle|The vehicle control has the same composition as KPI-121 0.25% ophthalmic suspension except it does not contain loteprednol etabonate. The vehicle is essentially isotonic and is buffered to maintain pH 5.0 - 7.0. It is a sterile, aqueous solution supplied in the same white, low-density polyethylene plastic dropper bottle with the same white, controlled-drop polyethylene tip and white polypropylene closure as KPI-121 0.25% ophthalmic suspension.
16092448|NCT02218476|Drug|CoQ10|
16092449|NCT02218476|Drug|Placebo|
16092450|NCT02218463|Drug|Estradiol cream 0.01%|Apply a pea-sized amount to the labial adhesion with lateral traction twice daily
16092451|NCT02218463|Drug|Cetaphil|Apply a pea-sized amount to the labial adhesion with lateral traction twice daily
16092452|NCT02218437|Drug|MSC+ATG|MSC+ATG:Starting dose was 0.5-1.0 × 106 cells /kg; And the maximum tolerated dose was 1 ×107 cells /kg after ATG application.
16092453|NCT02218424|Drug|Magnesium|
16092454|NCT02218424|Drug|Normal saline|
16092455|NCT02218411|Other|Exercise training|Exercises routine based on the Otago exercise programme
16092456|NCT02218398|Drug|Albuterol|
16092457|NCT02218385|Device|ForeCYTE Breast Aspirator|ForeCYTE Breast Aspirator used for bilateral collection of Nipple Aspirate Fluid (NAF) for cytologic testing
16092458|NCT02218372|Drug|Fidaxomicin oral suspension|Participants from birth to < 6 years of age received weight based doses of fidaxomicin oral suspension (32 mg/kg/day with a maximum dose of 400 mg/day divided in 2 doses) 2 times daily for 10 days.
16092459|NCT02218372|Drug|Fidaxomicin tablets|Participants aged ≥ 6 years to < 18 years of age received a 200 mg fidaxomicin tablet 2 times daily for 10 days.
16092460|NCT02218372|Drug|Vancomycin oral liquid|Participants from birth to < 6 years of age received weight based doses of vancomycin oral liquid (40 mg/kg/day with a maximum dose of 500 mg/day divided in 4 doses) 4 times daily for 10 days.
16092461|NCT02218372|Drug|Vancomycin capsules|Participants aged ≥ 6 years to < 18 years of age received a 125 mg vancomycin capsule 4 times daily for 10 days.
16092462|NCT02218359|Drug|Amikacin Fosfomycin Inhalation Solution|300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the AFIS Inline System
16092463|NCT02218359|Drug|Aerosolized placebo|Placebo twice daily for Days 1 -5 to be administered by aerosol using the eFlow Inline System.
16092464|NCT02218359|Drug|Amikacin Fosfomycin Inhalation Solution|Open-label crossover for all patients Days 6-10
16092465|NCT02218346|Drug|AG221|AG221 in fed and fasted conditions
16092466|NCT02218333|Dietary Supplement|Milk|4 dl milk will be consumed daily with breakfast and supper for 12 weeks
16092467|NCT02218333|Dietary Supplement|Placebo|
16092468|NCT02218320|Drug|Raltegravir|
16092469|NCT02218320|Drug|Dolutegravir|
16092470|NCT02218320|Procedure|Colonoscopy with biopsy|This procedure is not standard of care for patients receiving combination antiretroviral therapy (cART), but is necessary to obtain tissue samples.
16092471|NCT02218307|Drug|Mupirocin|
16092472|NCT02218307|Drug|Placebo|
16092473|NCT02218294|Drug|BCX4161|
16092474|NCT02218281|Behavioral|C2Q-Teen app|Commit to Quit (C2Q)-Teen app provides smoking cessation assistance incorporating mindfulness training.
16092475|NCT02218281|Behavioral|NCI's QuitSTART app|NCI's smoking cessation app
16092476|NCT02218281|Behavioral|Written smoking cessation materials only|Receipt of written smoking cessation materials
16092477|NCT02218268|Drug|Pre-meal bolus|Long acting insulin as scheduled per usual routine PLUS rapid/ short acting (bolus) prior to Boost
16092478|NCT02218268|Drug|No meal bolus|Long Acting insulin as scheduled per usual routine (given once daily)
16092479|NCT02218255|Device|Eeva™ results|
16092480|NCT02218242|Device|Intraoperative ultrasound|Intraoperative ultrasound will be performed at the completion of the standard lung cancer resection with mediastinal lymph node dissection. This evaluation will be performed by a different surgeon from the primary surgeon performing the operation to minimize operator variability with the ultrasound system and help control for bias. Additional lymph nodes identified will be resected and sent for pathologic evaluation. It is anticipated that this additional evaluation and treatment should take no more than 30 minutes and as such a time limit of 30 minutes from introduction of the ultrasound probe into the surgical field will be set.
16092481|NCT02218229|Device|Shock wave|Shock waves are defined a sequence of acoustic pulse characterized by a high peak pressure (100 MPa), fast pressure rise (< 10 ns) and short duration (10 μs). Different studies and clinical experiments have demonstrated the efficacy of shock waves in the treatment of musculoskeletal system such as chronic tendinopathies or hypertrophic pseudoarthrosis
16092482|NCT02218216|Device|MRI Diagnostic|Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences
16092483|NCT02218203|Drug|Dextromethorphan|Administered in 4 periods (placebo, low dose, medium dose, and high dose) for each subject, relative to each subject's MTD)
16092484|NCT02218203|Drug|Lidocaine|0mg, 1mg, 2mg, and 4mg Lidocaine per kg of lean body mass (LBM), during each of the 4 dextromethorphan periods (placebo, low dose, medium dose, and high dose)
16092485|NCT02218203|Drug|Placebo (Dextromethorphan)|0mg Dextromethorphan
16092486|NCT02218203|Drug|Placebo (Lidocaine)|0mg/kg LBM Lidocaine
16092487|NCT02218190|Drug|Alvimopan|
16092488|NCT02218190|Drug|Placebo|
16092489|NCT02218177|Drug|Aflibercept|anti-VEGF treatment for wet age related macular degeneration
16092490|NCT02218177|Drug|Ranibizumab|anti-VEGF treatment for wet age related macular degeneration
16092491|NCT02218177|Procedure|Combination Photodynamic Therapy|Use of cold laser with an intravitreal injection of dexamethasone to treat wet age related macular degeneration
16092495|NCT02218151|Other|Patient-Centered Medical Home (PCMH)|Subjects will receive their conditioning chemotherapy +/- radiation and stem cells in the hospital or day hospital, after which they will receive care during the neutropenic/recovery period at home. Advanced Practice Providers (APP) will travel to subjects' homes in the morning, where they will perform the same daily assessment as standard care. They will draw labs and bring them back to the hospital for processing. When results are available, a second home visit is made to deliver necessary interventions. Subjects will have internet access through cellular-networked iPads and have daily videoconferences with their physicians. Daily follow up at home will continue until discharge as per above criteria.
16092496|NCT02218151|Other|Standard Care|Subjects will receive their conditioning chemotherapy +/- radiation and stem cells in the hospital or day hospital, after which they will receive care during the neutropenic/recovery period inpatient or outpatient. Advanced practice providers (APPs) will perform histories and physical exams. Nurses will collect labs and inpatient rounds occur twice daily, or for outpatients receiving care through our outpatient clinics, a healthcare provider typically sees them daily for the first month following transplant or discharge from the day hospital.
16092497|NCT02218138|Behavioral|Learning 2 BREATHE|Mindfulness-based group program
16092498|NCT02218138|Behavioral|Colorado Blues|Colorado Blues, Cognitive-behavioral depression prevention group
16092499|NCT02218125|Biological|MVA Mosaic|0.5 mL (1x10E8 pfu) MVA Mosaic (comprised of MVA Mosaic 1 and MVA Mosaic 2 mixed in a 1:1 ratio before administration) will be administered by intramuscular (IM) injection.
16092500|NCT02218125|Biological|Placebo|0.5 mL Sodium Chloride Injection USP, 0.9%will be administered by intramuscular (IM) injection.
16092501|NCT02218112|Procedure|bariatric surgery (gastric bypass)|
16092502|NCT02218099|Drug|ASP8232|Oral
16092503|NCT02218099|Drug|Placebo|Oral
16092504|NCT02218086|Device|Slackline|Slackbase PRO CE: certificated by european law for medical devices (EG Richtlinie 93/42/EWG)
16092505|NCT02218086|Device|Wobbling Board|Wobbling Board CE: certificated by european law for medical devices (EG Richtlinie 93/42/EWG)
16092506|NCT02218086|Device|Pre-training|First investigation of the beginners with less than 1 hour experience with slacklining.
16092507|NCT02218086|Device|Fix visual anchor|Professionals have to gaze at a fixed visual anchor during the slacklining.
16092508|NCT02218086|Device|Moving visual anchor|Professionals have to gaze at a moving visual anchor during the slacklining.
16092509|NCT02218086|Device|Post-training|Second investigation of the beginners occurs after a training session of 9 times 30 minutes within a few weeks.
16092510|NCT02218086|Device|Slackline vs. standing-on-1-leg vs. control|beginners have to train 9 times ~15minutes within y few weeks.
16092511|NCT02218073|Drug|JNJ-42756493 10 mg tablet|Participants will be administered with 10 milligram (mg) JNJ-42756493 tablet orally either on Day 1 of Period 1 or on Day 1 of Period 2.
16092512|NCT02218073|Drug|JNJ-42756493 10 mg Oral Solution|Participants will be administered with 10 mg JNJ-42756493 oral solution either on Day 1 of Period 1 or on Day 1 of Period 2.
16092513|NCT02218073|Drug|JNJ-61818549|Participants will receive 100 mcg of JNJ-61818549 as intravenous injection on Day 1 of Period 2 or Day 1 of Period 1.
16092514|NCT02218060|Procedure|Coronary CT angiography on SOMATOM Force|Coronary CT angiography using iodinated contrast; metoprolol and/or nitroglycerin may also be administered on a per-patient basis
16092515|NCT02218060|Procedure|Previous coronary CT angiography on 2nd generation CT scanner|Clinically indicated coronary CT angiography previously performed on a 2nd generation CT scanner
16092516|NCT02218047|Drug|Pegylated-Proline-interferon alpha-2b|Subjects will continue to receive the dosage which delivers the optimal disease response (hematocrit [Hct]<45%, platelets [PLTs]<400 x 109/L and leukocytes [WBCs]<10 x 109/L), as determined in the PROUD-PV study, preferably at the level of target blood values.
16092517|NCT02218047|Drug|Best available therapy (BAT)|Best available therapy as selected by the investigator
16092518|NCT02218034|Drug|AGN-190168 Formulation 1|AGN-190168 Formulation 1 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
16092519|NCT02218034|Drug|AGN-190168 Formulation 2|AGN-190168 Formulation 2 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
16092520|NCT02218034|Drug|tazarotene gel 0.1%|Tazarotene gel 0.1% applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
16092521|NCT02218034|Drug|tazarotene cream 0.1%|Tazarotene cream 0.1% cream applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
16092522|NCT02218021|Drug|Samidorphan|
16092523|NCT02218021|Drug|Placebo|
16092524|NCT02218021|Drug|Oxycodone|
16092525|NCT02218008|Drug|ALKS 5461|Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
16092526|NCT02218008|Drug|Placebo|Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
16092624|NCT02217436|Device|iPad|iPad with age-appropriate applications, videos, and music
16094271|NCT02205372|Drug|Placebo|
16092527|NCT02217995|Behavioral|Mindfulness-Based Cognitive Therapy (MBCT)|"MBCT teaches patients to become more aware of, and to relate differently to, their thoughts, feelings, and bodily sensations. Through MBCT, patients will learn skills that allow them to disengage from habitual (automatic) dysfunctional cognitive routines, such as obsessional thinking. As an example, patients are encouraged to relate to thoughts and feelings as passing events in the mind, rather than to identify with them or treat them as accurate representations of reality. The MBCT protocol for OCD patients is adapted from Segal et al.'s original MBCT manual for depression (Segal, Williams & Teasdale, 2002)."
16092528|NCT02217982|Drug|Simethicone|
16092529|NCT02217982|Drug|Loperamide|
16092530|NCT02217982|Other|Peanut Butter|
16092531|NCT02217969|Behavioral|Electronic alert to SLUScore increase|Treat hypotension to minimize further progression of the SLUScore
16092532|NCT02217956|Drug|Cisplatin|
16092533|NCT02217956|Drug|Bevacizumab|
16092534|NCT02217943|Procedure|Roux-en-Y gastric bypass|
16092535|NCT02217943|Procedure|Sleeve gastrectomy|
16092536|NCT02217930|Drug|WCK 2349|
16092537|NCT02217930|Drug|Placebo|
16092538|NCT02217930|Drug|Moxifloxacin|
16092539|NCT02217917|Drug|Rivipansel|Rivipansel administered as a single dose subcutaneously with rHuPH20 in cross-over fashion. Each subject may receive up to 4 study treatments (placebo and up to 3 doses of rivipansel). The planned dose levels are 350 mg, 1210 mg, and 4200 mg (these are subject to change based on emerging data).
16092540|NCT02217917|Drug|Placebo|Matched Placebo administered as single dose subcutaneously with rHuPH20.
16092541|NCT02217917|Drug|Rivipansel|Rivipansel administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20. Planned doses are 1400 mg loading and 700 mg maintenance for 12 doses (these are subject to change based on emerging data).
16092542|NCT02217917|Drug|Rivipansel|Rivipansel administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20. Planned doses are 2800 mg loading and 1400 mg maintenance for 12 doses (these are subject to change based on emerging data).
16092543|NCT02217917|Drug|Placebo|Matched Placebo administered q12h for 7 days (a total of 13 doses) subcutaneously with rHuPH20.
16092544|NCT02217904|Drug|1 mg islatravir|Single oral dose of 1 mg islatravir administered following ≥8 hour fast
16092545|NCT02217904|Drug|2 mg islatravir|Single oral dose of 2 mg islatravir administered following ≥8 hour fast
16092546|NCT02217904|Drug|10 mg islatravir|Single oral dose of 10 mg islatravir administered following ≥8 hour fast
16092547|NCT02217904|Drug|30 mg islatravir|Single oral dose of 30 mg islatravir administered following ≥8 hour fast
16092548|NCT02217904|Drug|0.5 mg islatravir|Single oral dose of 0.5 mg islatravir administered following ≥8 hour fast
16092549|NCT02217904|Drug|0.25 mg islatravir|Single oral dose of 0.25 mg islatravir administered following ≥8 hour fast
16092550|NCT02217891|Behavioral|Semi-structured interview|Pts will participate in a 45-60-minute, one-on-one, audio-recorded interview. They will be conducted over the telephone or in person at the MSK Counseling Center. They will be conducted in accordance with a semi-structured interview guide developed by our study team of experts in clinical genetics, health psychology, & qualitative methodology. Topics to be covered in the interview include: 1) perceived potential benefits & harms of tumor genomic profiling; 2) interest in & perceived benefits & harms of incidental findings arising from tumor genomic profiling; 3) anticipated process & needs for decision-making about learning incidental findings; 4) interest in learning specific kinds of incidental findings (including those related to treatable diseases, different cancers, non-treatable diseases, & those that only have meaning for family members); 5) preferences about sharing incidental findings with other people; & 6) implications of & concerns about incidental findings for family.
16092551|NCT02217878|Drug|Morphine|IV bolus injection
16092552|NCT02217878|Drug|Placebo|IV bolus injection
16092553|NCT02217878|Drug|Ticagrelor|180 mg loading dose
16092554|NCT02217865|Behavioral|Interviews - Colorectal Cancer Participants|Semi-structured interviews conducted exploring key issues relevant to colorectal cancer surveillance following curative resection. Interviews take between 30 minutes and 1 hour.
16092555|NCT02217865|Behavioral|Questionnaire|Questionnaire completion asking general health and demographic questions.
16092556|NCT02217865|Behavioral|Focus Groups|Focus groups conducted with participants and caregivers. Up to 4 focus groups conducted with up to 30 participants each. Focus groups expected to take 30 to 60 minutes.
16092557|NCT02217865|Behavioral|Interviews - Caregivers of Colorectal Cancer Participants|Semi-structured interviews conducted exploring key issues relevant to colorectal cancer surveillance following curative resection. Interviews take between 30 minutes and 1 hour.
16092558|NCT02217852|Drug|Nitrendipine|doses used range from 10-20mg po bid. Total duration would be until completion or study or medication intolerance.
16092559|NCT02217852|Drug|Hydrochlorothiazide|doses used range from 12.5-25mg po qd. Total duration would be until completion or study or medication intolerance.
16092560|NCT02217852|Drug|Captopril,Hydrochlorothiazide|doses used range from 25-50mg po tid for captopril and 12.5-25mg po qd for hydrochlorothiazide. Total duration would be until completion or study or medication intolerance.
16092561|NCT02217852|Drug|Beijing hypotensive No.0|1 pile po qd or less. Total duration would be until completion or study or medication intolerance.
16092562|NCT02217839|Drug|DG3173|
16092563|NCT02217839|Drug|DG3173+Octreotide|
16092564|NCT02217839|Drug|Octreotide|
16092565|NCT02217839|Drug|DG3173 Placebo|
16092566|NCT02217839|Drug|DG3173 Placebo+Octreotide Placebo|
16092567|NCT02217839|Drug|Octreotide+DG3173 Placebo|
16092568|NCT02217826|Drug|DG3173|
16092569|NCT02217826|Drug|Saline|
16092570|NCT02217826|Drug|Octreotide|
16092571|NCT02217813|Drug|Tafamidis|20 mg of current commercial formulation
16092572|NCT02217813|Drug|Tafamidis|20 mg of new formulation
16092573|NCT02217800|Drug|saline|Eligible patients are to receive a constant 23 hour subcutaneous infusion of saline as placebo comparator and will be randomized in an equal ratio to one of three treatment sequences of doses of 920, 2760 and 5520 µg DG3173 by constant 23 hour subcutaneous infusions in a random sequence followed by three subcutaneous injections of 300 µg octreotide at approximately 8 hour intervals as an active comparator.
16092969|NCT02214823|Device|FES-Cycling|
16092574|NCT02217800|Drug|DG3173|Eligible patients are to receive a constant 23 hour subcutaneous infusion of saline as placebo comparator and will be randomized in an equal ratio to one of three treatment sequences of doses of 920, 2760 and 5520 µg DG3173 by constant 23 hour subcutaneous infusions in a random sequence followed by three subcutaneous injections of 300 µg octreotide at approximately 8 hour intervals as an active comparator.
16092575|NCT02217800|Drug|octreotide|Eligible patients are to receive a constant 23 hour subcutaneous infusion of saline as placebo comparator and will be randomized in an equal ratio to one of three treatment sequences of doses of 920, 2760 and 5520 µg DG3173 by constant 23 hour subcutaneous infusions in a random sequence followed by three subcutaneous injections of 300 µg octreotide at approximately 8 hour intervals as an active comparator.
16092576|NCT02217787|Drug|PF-06372865|7.5 mg as 3 x 2.5 mg tablets single dose
16092577|NCT02217787|Drug|PF-06372865|7.5 mg as 3 x 2.5 mg tablets single dose
16092578|NCT02217774|Device|MGUIDE MORE|MGUIDE MORE System (MGS), consisting of MGUIDE MORE software, MGUIDE MORE surgical kit and MGUIDE MORE template, will be used for planning, drilling and inserting dental implants.
16092579|NCT02217748|Other|Survey questionnaire|
16092580|NCT02217735|Behavioral|Writing Intervention|Participants wrote for 20 minutes on three occasions about an emotional or traumatic topic (expressive writing intervention condition) or what they did the day before, while refraining from including emotional details.
16092581|NCT02217722|Other|Ulcerative Colitis Diet|we have postulated that a diet that increases butyrate through fiber exposure, reduces intestinal sulfur exposure, and increases vitamin D levels could be beneficial for patients with Ulcerative Colitis. To date, no study has explored this possibility.
16092582|NCT02217722|Drug|Antibiotic cocktail|We have postulating that antibiotic therapy can alter the microbiota clinically. Controlling the microbiota by antibiotics may allow for control of the disease without immune suppression
16092583|NCT02217709|Drug|phenelzine sulfate|Given by mouth
16092584|NCT02217709|Other|laboratory biomarker analysis|Correlative studies
16092585|NCT02217709|Other|questionnaire administration|Ancillary studies
16092586|NCT02217696|Other|Computerized reading training|
16092587|NCT02217683|Drug|Nitric Oxide|Nitric oxide at 80 part per million will be administrated by inhalation for approximately 1 hour during the blood transfusion
16092588|NCT02217670|Drug|Metformin 1000 mg granules|
16092589|NCT02217670|Drug|Metformin 1000 mg film-coated tablets|
16092590|NCT02217657|Device|Thermocool Smart Touch Catheter|Physician informed to contact force
16092591|NCT02217644|Drug|BI 653048 H3PO4 solution|
16092592|NCT02217644|Drug|BI 653048 H3PO4 low dose capsule|
16092593|NCT02217644|Drug|BI 653048 H3PO4 high dose capsule|
16092594|NCT02217644|Drug|Placebo|
16092595|NCT02217631|Drug|BI 653048 BS H3PO4|
16092596|NCT02217631|Drug|Prednisolone low dose|
16092597|NCT02217631|Drug|Prednisolone high dose|
16092598|NCT02217631|Drug|Placebo|
16092599|NCT02217618|Drug|LY2409021|
16092600|NCT02217605|Dietary Supplement|Fructose|Oral Fructose Challenge (75 g fructose in 500 ml water) following overnight fast
16092601|NCT02217579|Dietary Supplement|Protein|A food containing 5 grams/serving of supplemental protein.
16092602|NCT02217579|Dietary Supplement|Prebiotic fiber|A food containing 8 grams/serving of supplemental prebiotic fiber.
16092603|NCT02217579|Dietary Supplement|Protein plus prebiotic fiber|A food containing supplemental protein (5 grams/serving) and prebiotic fiber (8 grams/serving).
16092604|NCT02217579|Dietary Supplement|Control|An isocaloric food not containing the test protein and fiber.
16092605|NCT02217566|Drug|Abiraterone acetate|Participants will receive abiraterone acetate 1000 mg (4*250 mg tablets) orally once daily until PSA progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity.
16092606|NCT02217566|Drug|Prednisone|Participants will prednisone 5 mg orally once daily from Day 1 of Cycle 1 and continues until PSA progression, clinical progression, consent withdrawal, or the occurrence of unacceptable toxicity.
16092607|NCT02217566|Drug|Androgen deprivation therapy (ADT)|Participants will remain on a stable regimen of ADT, that is, luteinizing hormone-releasing hormone (LHRH) agonists including leuprolide acetate and goserelin acetate as per Investigator's discretion.
16092608|NCT02217553|Drug|Cholecalciferol|The study participants will receive 180 soft gel cholecalciferol capsules, to be taken 2 capsules once a day for 90 days
16092609|NCT02217540|Other|Standard protocol|Control group intervention is the physiotherapy treatment standard protocol proposed by the Spanish Rheumatology Society for shoulder dysfunction
16092610|NCT02217540|Other|Mulligan Concept Mobilisation with Movement|The internal hand of the physiotherapist stabilises participants´ shoulder girdle and with the thenar eminence of the other hand, performs a posterior-lateral glide of the humeral head. Participants are asked to raise the affected arm in the point of pain onset while the physiotherapist sustains the gliding force to humeral head. The physiotherapist tries to maintain the glide at right angles to the plane of movement throughout the entire range while participants are requested to perform an active elevation. Participants are instructed that the mobilisation procedure, including shoulder movement, had to be pain free
16092611|NCT02217527|Drug|Active JNJ Drug|200 mg/day (100 mg b.i.d.) of Active JNJ Drug will be used for one week while attempting to briefly quit smoking on Mon-Fri of that week.
16092612|NCT02217527|Drug|Placebo pill|Placebo pill will be taken daily to assess ability to briefly quit smoking on Mon-Fri for one week.
16092613|NCT02217514|Drug|Midazolam|
16092614|NCT02217514|Drug|BI 44370 low dose|
16092615|NCT02217514|Drug|BI 44370 medium dose|
16092616|NCT02217514|Drug|BI 44370 high dose|
16092617|NCT02217501|Drug|Clopidogrel|Clopidogrel 75 mg once daily for clinically indicated duration or for clinically indication duration + 12 months
16092618|NCT02217501|Drug|Acetylsalicylic acid (ASA)|Acetylsalicylic acid (ASA) 75-100 mg once daily for clinically indicated duration or for clinically indication duration + 12 months
16092619|NCT02217488|Drug|DG3173|
16092620|NCT02217488|Drug|Placebo|
16092621|NCT02217475|Drug|Cenicriviroc|CVC 150 mg, administered orally once daily and taken every morning with food.
16092622|NCT02217475|Drug|Placebo|Placebo administered orally once daily and taken every morning with food.
16092623|NCT02217449|Other|Prediction of histology|
16092625|NCT02217436|Other|Standard Care|All study participants will receive standard care, which consists of procedural explanation and preparation by providers, verbal encouragement and comforting by providers and parents, and topical anesthetic (LET) followed by injectable lidocaine administration (whether one or both of these anesthetics will be used will be determined by the provider prior to randomization).
16092626|NCT02217423|Other|Chest physiotherapy chest wall expansion|chest physiotherapy The protocol consisted of breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises of chest wall expansion (decompression, Incentive Spirometry).
16092627|NCT02217423|Other|Chest physiotherapy airway clearance modality|The protocol will be consisted the breathing exercises during 30 minutes: passive and localized exercises, deep diaphragmatic breathing and exercises on the chest (vibration, compression) and active cough.
16092628|NCT02217410|Biological|CFZ533|
16092629|NCT02217410|Drug|Tacrolimus (Tac)|
16092630|NCT02217410|Drug|Mycophenolate mofetil (MMF)|
16092631|NCT02217410|Drug|Corticosteroids (CS)|
16092632|NCT02217410|Biological|anti-IL2 Induction|
16092633|NCT02217397|Device|OA, CPAP, combination therapy|
16092634|NCT02217371|Other|Neuropsychological tests|"The tests are :
~Go/NoGo paradigm, Continuous Performance Test (CPT) II , Wisconsin Card Sorting Test (WCST), virtual CPT, Classic and virtual Stroop, PSG, MWT
~These tests will be repeated during 32h each 4h (T0h, T4h, T8h, T12h, T16h, T20h, T24h, T28h et T32h)."
16092635|NCT02217358|Device|NBI endoscopy|"see in detail description of the study part of the protocol"
16092636|NCT02217345|Drug|Growth hormone|
16092637|NCT02217345|Drug|Placebo|
16092638|NCT02217332|Drug|dexpramipexole|Dexpramipexole capsule-shaped film-coated tablets at the dose strength of 150 mg administered orally as 1 tablet twice daily (300 mg/day)
16092639|NCT02217319|Drug|Sevoflurane|Anaesthesia is induced (1-2 mg/kg) and maintained (5-7 mg/kg/h) with propofol and remifentanil (1 µg/kg and 0,2-0,4 µg/kg/min). After induction of anesthesia the propofol infusion is stopped and patients receive 1 MAC Sevoflurane over 30 min. Then the propofol infusion is restarted and Sevoflurane is washed out.
16092640|NCT02217319|Drug|TIVA|Anaesthesia is induced (1-2 mg/kg) and maintained (5-7 mg/kg/h) with propofol and remifentanil (1 µg/kg and 0,2-0,4 µg/kg/min).
16092641|NCT02217293|Device|Pulsed Radiofrequency|Pulsed radiofrequency (PRF) treatment, a relative novel pain intervention at recent decade, was found to be able to alleviate pain by delivering an electrical field and heat bursts at a temperature less than 42°C to neural tissue in the absence of neural injury. The ultrasound-guided PRF was performed before night splint in intervention group.
16092642|NCT02217280|Drug|Injection with Gadolinium|Gadavist (gadobutrol) injection is a gadolinium-based contrast agent indicated for intravenous use in diagnostic magnetic resonance imaging (MRI) in adults and children (2 years of age and older) to detect and visualize areas with disrupted blood brain barrier (BBB) and/or abnormal vascularity of the central nervous system
16092643|NCT02217267|Drug|Lidocaine|Lidocaine 3 mg/kg dilute in Normal Saline to 50 ml intravenous infusion in 1 hour
16092644|NCT02217267|Drug|Placebo|
16092645|NCT02217254|Procedure|Atrial fibrillation catheter ablation using the Medtronic Arctic Front Ablation System|
16092646|NCT02217241|Other|Handoff Workshop|
16092647|NCT02217228|Device|Sebacia microparticles and laser|
16092648|NCT02217228|Device|Vehicle suspension and laser|
16092649|NCT02217228|Device|Sebacia microparticles without laser|
16092650|NCT02217215|Device|CNDS Advanced Cervical Scan|"Subjects (approximately 500) will be initially enrolled from a general screening population in the first phase, and during the second phase from the colposcopy clinic population (approximately 300) based on their referral abnormal Pap cytology conducted within 120-days in order to achieve a statistically viable number of normal women, women with CIN1/2 and women with CIN3+, as described in Section 6.1, Cervical Cytology Enrollment Targets. After the CNDS test, a sample for Hybrid Capture 2 HPV testing and liquid cytology will be collected in addition to colposcopy and biopsy, if indicated."
16092651|NCT02217202|Device|Aquacel Ag dressing|Participants will have their knee arthroplasty wound dressed using the Aquacel Ag dressing instead of the standard Aquacel dressing.
16092652|NCT02217189|Dietary Supplement|zinc sulfate|The subfertile group treated with zinc sulfate, every participant took two capsules of zinc sulfate per day for three months (each one 220 mg).
16092653|NCT02217163|Drug|Carfilzomib, , Cyclophosphamide, Dexamethasone|Carfilzomib is administered intraveneously over 30 minutes. For cycle 1 only, Carfilzomib is administered at 20mg/m2 on Day 1 and 2, dose will be escalated to 36mg/m2 on Day 8,9,15 and 16 of the 28-days cycle. Patients who tolerate the 36mg/m2 dose are kept at this dose for the subsequent cycles on Day 1,2,8,9,15,16 on a 28 days cycle. Cyclophosphamide is given at a fixed dose of 500mg once per week orally, along with dexamethasone which is given on the days of Carfilzomib administration, 30 minutes to 4 hours prior to Carfilzomib infusion.
16092654|NCT02217124|Other|dried apples|120 calories
16092655|NCT02217124|Other|muffin|120 calories
16092656|NCT02217111|Behavioral|Adventures in Voice: Pediatric Voice Therapy|
16092657|NCT02217098|Procedure|GIC Restorations|Restorations using Glass Ionomer Cement
16092658|NCT02217098|Procedure|Carbomer Restorations|Restorations using Glass Carbomer
16092659|NCT02217098|Procedure|Compomer Restorations|Restorations using Compomer
16092660|NCT02217072|Behavioral|School intervention|A school-based intervention that builds on the promising Swedish programme SkolFam, but is adapted to a Danish school context. The two main components of the programme are a) comprehensive assessment of the child, involving testing of the child's cognitive and academic abilities and difficulties as well as an evaluation of the child's behaviour, school-related social relations and well-being, and b) a systematic and individually targeted intervention plan, made in collaboration between a psychologist, the teachers, and a special educational teacher at the school (e.g., the reading counsellor).
16092661|NCT02217072|Behavioral|Parents as Tutors|A home-based intervention, comprising a structured tutoring programme that allows foster parents to systematically support the foster child's school performance. Foster parents will attend an introductory tutor training seminar at which they will be introduced to relevant theory on learning and counselled on tutoring practice. The intervention itself is designed to provide approximately three hours per week of individual home-based tutoring for a period of 40 weeks.
16094272|NCT02205359|Device|aCRT ON|CRT device with AdaptivCRT enabled
16092662|NCT02217046|Procedure|device replacement(pocket capsule removal)|remove previously inserted cardiac device and posterior pocket capsule. the pocket that will receive the heart mechanism is sterilized with a hydroperoxide soaked gauze
16092663|NCT02217033|Other|'R' (Electro-kinetically altered beverage)|
16092664|NCT02217033|Other|Placebo (water)|
16092665|NCT02217020|Drug|FOLFOXIRI|irinotecan* 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle
16092666|NCT02217007|Drug|SNC-102 sustained release tablet|SNC-102 is an 800 mg tablet. It will be administered twice daily (morning and evening) for a total of 8 weeks: the initial 4 weeks will be 1 tablet in the morning and 1 tablet in the evening; the next 4 weeks will be 2 tablets in the morning and 1 tablet in the evening.
16092667|NCT02216994|Drug|high dose lactulose|The patients with a score less than 5 are mostly indicative of HAD, and receive conservative therapies that included colonic irrigation, enema, high dose lactulose, and oral paraffin oil for at least 6 months. When there is no clinical improvement, patients are consented for surgical procedures to remove the dysganglionic bowel segments.
16092668|NCT02216994|Behavioral|conservative treatment|The patients with a score less than 5 are mostly indicative of HAD, and receive conservative therapies that included colonic irrigation, enema, high dose lactulose, and oral paraffin oil for at least 6 months. When there is no clinical improvement, patients are consented for surgical procedures to remove the dysganglionic bowel segments.
16092669|NCT02216994|Drug|paraffin oil|The patients with a score less than 5 are mostly indicative of HAD, and receive conservative therapies that included colonic irrigation, enema, high dose lactulose, and oral paraffin oil for at least 6 months. When there is no clinical improvement, patients are consented for surgical procedures to remove the dysganglionic bowel segments.
16092670|NCT02216981|Behavioral|Cognitive Behavioural Therapy (CBT)|
16092671|NCT02216968|Behavioral|Increase vegetable intake in pre-school children|"6-week Intervention: 120 AA and HA children will be shown the Puppet Shows and will be given a bag of ingredients to prepare the vegetable highlighted that week in the Puppet Show. The 6 week intervention includes a baseline assessment (1 week), followed by the intervention (4 weeks), and post assessment (1 week). The primary hypothesis to be tested is children who receive the PUPPET intervention with a parent/teacher component will demonstrate increase vegetable intake in pre-school children."
16092672|NCT02216942|Drug|Endodontic treatment using Vitapex|Endodontic treatment using Vitapex
16092673|NCT02216942|Drug|Endodontic treatment using Guedes Pinto|Endodontic treatment using Guedes Pinto paste
16092674|NCT02216916|Drug|HM781-36B|
16092675|NCT02216890|Drug|SGN-CD70A|Given intravenously every 3 weeks (or an alternate dosing schedule up to every 6 weeks)
16092676|NCT02216877|Drug|Mablet 360 mg|
16092677|NCT02216877|Drug|Placebo|
16092678|NCT02216864|Procedure|Multiple Subcision|At the start of the procedure, a straight vitrectomy knife will be inserted subdermally and will be slowly advanced parallel to the dermis. Rapid advancement and retraction of the needle under the scarred area in a lancing motion will be performed to abrade the underside of the dermis followed by side to side sweeping motions attempting to break any fibrous attachments to the deeper tissues.
16092679|NCT02216851|Device|Restylane Perlane|Intradermal injection
16092680|NCT02216838|Drug|botulinum toxin A|A total of 10U will be injected at 1cm increments by the blinded dermatologist into the respective randomized side.
16092681|NCT02216838|Other|Saline Control|A total of 0.5cc benzyl alcohol containing saline will be injected at 1cm increments by the blinded dermatologist into the respective randomized side
16092682|NCT02216825|Dietary Supplement|Delayed release capsule, L. reuteri NCIMB 30242, escalated dose|
16092683|NCT02216825|Dietary Supplement|Standard vegetarian capsule, L. reuteri NCIMB 30242, escalated dose|
16092684|NCT02216812|Drug|500 mg vitamin c, 1 pill per day for 6 weeks|
16092685|NCT02216812|Drug|1 placebo pill for 6 weeks|
16092686|NCT02216799|Drug|Glargine Insulin|80% of the insulin doses administrated via sliding scale will be administered every night as insulin glargine
16092687|NCT02216799|Drug|Regular insulin|80% of the Regular insulin administrated via sliding scale will be will be added to TPN bag to run over 24 hours
16092688|NCT02216786|Drug|AZD2014|Oral tablet
16092689|NCT02216786|Drug|Everolimus|Oral tablet
16092690|NCT02216786|Drug|Fulvestrant|Im injection
16092691|NCT02216773|Procedure|Radiofrequency assisted liver partition with portal vein ligation (RALPP)|
16092692|NCT02216773|Procedure|Portal vein embolization (PVE)|
16092693|NCT02216760|Device|Ripple Mapping guided VT ablation|RM will be used to guide identification of conduction channels and hence substrate guided ablation
16092694|NCT02216760|Device|Conventional VT ablation|Substrate guided ablation using conventional methods (pace-mapping, LAVA/late potential abolition, scar border zone ablation)
16092695|NCT02216747|Drug|prednisone 60 mg/meter square Body Surface Area|treatment with prednisone 60 mg /meter square Body Surface Area to compare to other arms
16092696|NCT02216747|Drug|prednisone 45 mg|treatment with 45 mg prednisone to compare with other arms
16092697|NCT02216747|Drug|prednisone 30 mg|treatment with 30 mg prednisone to compare with other arms.
16092698|NCT02216734|Behavioral|Mother support groups for HIV+ mothers|Facility-based mother support groups (MSGs) for HIV+ mothers. MSGs were established prior to study enrolment. MSGs are facilitated by volunteer mothers. Groups meet every two weeks. Health information is provided by health workers during MSGs. Mothers receive HIV prevention, psychosocial and treatment support, reinforce safe feeding practices, promote linkages with family planning services and support disclosure by HIV+ mothers to partners, male attendance and male HIV treatment. Mothers leave MSGs 6 months postnatally. Volunteer MSG coordinators contact defaulting mothers visits using cell phones; VHWs may conduct home visits to to defaulting MSG members to reduce LTFU;
16092699|NCT02216708|Other|Rapid dehydration|
16092700|NCT02216708|Other|Slow rehydration|
16092701|NCT02216669|Drug|DTP348|Patients will receive a continuous oral dose of DTP348 for 7 days per week for 7 weeks
16092702|NCT02216656|Drug|Placebo|Oral administration
16092703|NCT02216656|Drug|KHK7580 low dose|Oral administration
16092704|NCT02216656|Drug|KHK7580 middle dose|Oral administration
16092705|NCT02216656|Drug|KHK7580 high dose|Oral administration
16092706|NCT02216656|Drug|KRN1493|Oral administration
16092707|NCT02216643|Procedure|Thrombectomy|Patients with acute ischemic stroke with anterior circulation large vessel occlusion will be randomized to receive mechanical thrombectomy with stent-retriever Solitaire FR® and/or thromboaspiration with Penumbra System® versus medical management alone versus medical management alone. A maximum of six attempts to retrieve the thrombus in a single vessel can be made . No additional treatment will be allowed either with IA tPA, other mechanical devices or angioplasty/stenting.
16092708|NCT02216643|Device|Stentriever Solitaire FR® or Penumbra System®|Patients with acute ischemic stroke with anterior circulation large vessel occlusion will be randomized to receive mechanical thrombectomy with stent-retriever and/or thromboaspiration versus medical management alone versus medical management alone. A maximum of six attempts to retrieve the thrombus in a single vessel can be made . No additional treatment will be allowed either with IA tPA, other mechanical devices or angioplasty/stenting.
16092709|NCT02216630|Drug|Adipose Derived Stem Cell (ADSC) Therapy|Patients undergo a liposuction where 100 cc of fat are extracted. The ADSCs are then isolated and injected intravenously.
16092710|NCT02216617|Drug|Taxotere, Cisplatin, Afatinib|
16092711|NCT02216604|Behavioral|Multimodal Exercise Intervention|During their inpatient hospitalization the participants perform 3-5x weekly guided training sessions about 15-30min. The intervention includes: game console-based training using Nintendo Wii® (endurance, strength endurance and balance), age-specific resistance training and sessions of body awareness. During the outpatient phases the participants perform a home-based exercise training 3-5x weekly using a training manual. In addition, the patients obtain a movement diary and a pedometer for documenting their activity level.
16092712|NCT02216591|Device|Active Cognitive Training (ACT)|
16092713|NCT02216591|Device|Control (CON)|
16092714|NCT02216578|Drug|cabozantinib|Oral
16092715|NCT02216565|Other|Hospitalization in specialized neuro-vascular unit|
16092716|NCT02216565|Drug|Alteplase if patient is eligible|Alteplase intravenous thrombolysis performed if patient is eligible (if not contraindicated)
16092717|NCT02216565|Other|Supportive care|Drugs, procedures and techniques aimed at preventing/managing complications or aggravation of the patient's neurological condition
16092718|NCT02216565|Procedure|Endovascular treatment|Recanalization treatment (thrombectomy / intraarterial thrombolysis)
16092719|NCT02216552|Dietary Supplement|Resveratrol|All adolescents will receive standardized lifestyle counselling at enrolment designed and disseminated by a registered dietitian as well as a licensed physiotherapist who both have experience working with overweight adolescents. The lifestyle component will be goal-based and tailored to each participant. The overall content and messaging will be consistent for all participants with nutritional recommendations based on Canada Food Guide and physical activity counselling aligning with the Healthy Active Living Recommendations of the Canadian Pediatric Society and Health Canada's Physical Activity Guidelines.
16092720|NCT02216552|Dietary Supplement|Placebo|All adolescents will receive standardized lifestyle counselling at enrolment designed and disseminated by a registered dietitian as well as a licensed physiotherapist who both have experience working with overweight adolescents. The lifestyle component will be goal-based and tailored to each participant. The overall content and messaging will be consistent for all participants with nutritional recommendations based on Canada Food Guide and physical activity counselling aligning with the Healthy Active Living Recommendations of the Canadian Pediatric Society and Health Canada's Physical Activity Guidelines.
16092721|NCT02216539|Behavioral|Self-hypnosis|Patients will be trained to self-hypnosis prior to surgery, in order to be able to use self-hypnosis as a pain-management tool after surgery
16092722|NCT02216539|Procedure|Lung transplantation|
16092723|NCT02216539|Other|Standard post-operative pain management|Post-operative pain management treatments as per usual protocols in the hospital
16092724|NCT02216526|Other|Cetaphil® Restoraderm|
16092725|NCT02216526|Other|Excipial|
16092726|NCT02216513|Drug|desferrioxamine (DFO)|DFO (20mg/kg/hr) in normal saline for 4 hours for 5 consecutive days
16092727|NCT02216513|Drug|placebo|normal saline IV for 4 hours for 5 consecutive days
16092728|NCT02216500|Dietary Supplement|Ketogenic Therapy|Ketogenic Therapy is based on a ratio of fat: protein+carbohydrate in which protein intake is adequate, fat intake is high, and carbohydrate intake is minimal.
16092729|NCT02216487|Drug|HA-Irinotecan|HA-Irinotecan is administered as part of FOLFIRI/cetuximab treatment in place of irinotecan for treatment of mCRC.
16092730|NCT02216474|Other|Transcranial direct current stimulation|
16092731|NCT02216461|Drug|Low dose of BIBW 2948 BS for oral inhalation|
16092732|NCT02216461|Drug|Medium dose of BIBW 2948 BS for oral inhalation|
16092733|NCT02216461|Drug|High dose of BIBW 2948 BS for oral inhalation|
16092734|NCT02216461|Drug|Placebo|
16092735|NCT02216448|Other|Training knee simulator|Training in a lab on a virtual reality knee arthroscopy simulator
16092736|NCT02216448|Other|OR Training|Training on diagnostic knee arthroscopy in the OR
16092737|NCT02216422|Drug|Ombitasvir/Paritaprevir/Ritonavir|Tablet; paritaprevir co-formulated with ritonavir and ombitasvir
16092738|NCT02216422|Drug|Dasabuvir|Tablet
16092739|NCT02216422|Drug|Ribavirin (RBV)|Tablet
16092740|NCT02216409|Drug|Hu5F9-G4|
16092741|NCT02216383|Drug|Carbetocin|The intervention is the administration of one dose of study drug to the recruited patient at the time of delivery. Carbetocin, listed here, is one of the of the three study drugs.
16092742|NCT02216383|Drug|Syntocinon|The intervention is the administration of one dose of study drug to the recruited patient at the time of delivery. Syntocinon, listed here, is one of the of the three study drugs.
16092743|NCT02216383|Drug|Syntometrine|The intervention is the administration of one dose of study drug to the recruited patient at the time of delivery. Syntometrine, listed here, is one of the of the three study drugs.
16092744|NCT02216357|Drug|Ifetroban, Oral Capsule|
16092745|NCT02216357|Drug|Placebo, Oral Capsule|
16092746|NCT02216331|Drug|TMC207|"This is a two group, 2 period study design with both groups in the first period receiving TMC207 alone, followed by one group in the second period receiving TMC207 in the presence of dosing with rifapentine and the other group receiving TMC207 in the presence of dosing with rifampicin. All treatments details specified under Arms description."
16092747|NCT02216331|Drug|rifapentine|
16092748|NCT02216331|Drug|rifampicin|
16092749|NCT02216318|Other|blue light|
16092750|NCT02216305|Procedure|Hemorrhoidectomy|Open hemorrhoidectomy may include one to three anal cushions and made according to the Milligan-Morgan technique, with resection of the anal cushion and the external hemorrhoidal epidermal component using electrocautery and ligation of the hemorroidal base with absorbable suture
16092751|NCT02216305|Procedure|HAL-RAR|Hemorrhoidal artery ligation and rectoanal repair will be performed with the AMI minimally invasive surgery device HAL/RAR, and consist in the ligation of the terminal branches of the superior rectal artery with 2-0 absorbable polyglycolic acid suture after identifying the blood flow approximately 3 cm above the dentate line by using Doppler guidance. Subsequently, a running suture was added from the suture point to 5 mm above the dentate line to lift the prolapsing hemorroid. Other procedures will not be associated.
16092752|NCT02216292|Other|Control Group|Infants received preterm formula during their first days of life until breastmilk from their own mother was available
16092753|NCT02216292|Other|Preterm Single Donor Milk Group|Infants received preterm single donor milk during their first days of life until breastmilk from their own mother was available
16092754|NCT02216279|Drug|PulmoBind|PulmoBind is a peptide derived from human adrenomedullin (hAM1-52), labelled with 99mTc (imaging isotope used in clinical medicine).
16092755|NCT02216266|Drug|Physostigmine|
16092756|NCT02216266|Other|Sodium Chloride solution|
16092757|NCT02216253|Drug|L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract|L-methionine, Hibiscus Sabdariffa and Boswellia Leaf Extract tablet twice a day 7 days before and after surgery
16092758|NCT02216253|Other|Placebo|Placebo tablet twice a day 7 days before and after surgery
16092759|NCT02216240|Other|Paramedic|
16092760|NCT02216240|Other|Standard care|
16092761|NCT02216227|Drug|Mupirocin|Patients with known positive MRSA or MSSA and patients who have unknown status will decolonize BID x 5 days
16092762|NCT02216227|Drug|Chlorhexidine gluconate|"Patients that are MRSA or MSSA positive or have unknown status will bathe in CHG daily x 5 days.
~Patients that are MRSA or MSSA negative will bathe with CHG the night before and morning of surgery."
16092763|NCT02216227|Drug|Cefazolin|All patients will receive Cefazolin during surgery
16092764|NCT02216227|Drug|Vancomycin|Patients who are positive for MRSA, or have unknown MRSA status, will receive vancomycin along with cefazolin during surgery.
16092765|NCT02216227|Drug|Nasal Povidone Iodine|The purpose of this research is to evaluate a SSI checklist. This checklist includes decolonizing a patient's nose and skin and optimizing antibiotics prior to surgery. At the time that we wrote it, the predominate product to decolonize patient's noses was mupirocin. However, in 2017, an FDA final monograph stated that nasal povidone-iodine may be used for pre-surgical decolonization. Nasal povidone-iodine should be able to overcome barriers to checklist implementation that we identified in Aim 3. We now plan to replace the nasal agent mupirocin with the nasal agent povidone-iodine at 3 participating medical centers (Iowa City VA, Minneapolis VA and Portland VA) to assess whether this overcomes the barriers to our SSI checklist.
16092766|NCT02216214|Drug|Mirabegron|oral tablet
16092767|NCT02216214|Drug|Placebo|oral tablet
16092768|NCT02216188|Biological|AFFITOPE® PD01A|s.c. injection
16092769|NCT02216188|Other|Control|Untreated control group
16092770|NCT02216175|Other|SLIT to cow's milk|Sublingual immunotherapy
16092771|NCT02216175|Other|Low dose OIT|Oral Immunotherapy (low dose)
16092772|NCT02216175|Other|Conventional OIT to cow's milk|Oral Immunotherapy
16092773|NCT02216162|Other|Arm A: adapted physical activity + enhanced geriatric follow-up|"Patients have 3-monthly geriatric follow-up with biological tests, anti-aromatase agents blood dosing and a clinical assessment (M3 to M9, M15 to M22 and M27 to M33). Musculoskeletal adverse events and quality of life level will be reported and analgesic treatment adapted. Patients will be proposed weekly Taï-Chi exercises to improve joint flexibility, muscular tonus and balance and reduce fall risk.
~A broader geriatric assessment including functionality, gait analysis and nutrition will be performed each year (M12, M24 and M36)."
16092774|NCT02216162|Other|No intervention|Usual clinical follow-up
16092775|NCT02216149|Drug|S-1|S-1 25 mg/m2/day BID d1-14, oxaliplatin injection 130 mg/m2 D1 every 3 weeks
16092776|NCT02216149|Drug|Capecitabine|capecitabine 2000 mg/m2/day divided in 2 daily doses d1-14, oxaliplatin injection 130 mg/m2 D1 every 3 weeks
16092777|NCT02216149|Drug|Oxaliplatin|Oxaliplatin 130 mg/m2 D1 every 3 weeks
16092778|NCT02216123|Drug|Tafenoquine|Tafenoquine will be supplied as a dark pink, capsule-shaped, film-coated tablet that is plain on both sides. Each tablet will contain 150mg TQ.
16092779|NCT02216123|Drug|Tafenoquine Placebo|Placebo TQ tablets will be supplied as a dark pink, capsule-shaped, film-coated tablet that is plain on both sides, with common excipients of appropriate quality.
16092780|NCT02216123|Drug|Chloroquine|"One of two formulations of commercially available generic chloroquine may be utilized in this study:
~tablets containing 500 mg chloroquine phosphate (equivalent to 300 mg chloroquine free base); or,
~tablets containing 250 mg chloroquine phosphate (equivalent to 155 mg chloroquine free base)."
16092781|NCT02216123|Drug|Primaquine|Commercially available primaquine containing primaquine phosphate united states pharmacopeia (USP), 26.3 mg (equivalent to primaquine base 15 mg) will be utilized in this study. Primaquine, a pink film-coated tablet imprinted W on one side and P97 on the other side. The PQ tablets for this study have been over-encapsulated in a Swedish orange size B supro capsule.
16092782|NCT02216123|Drug|Primaquine Placebo|Placebo to match PQ will be supplied as Swedish orange size B supro capsules with common excipients of appropriate quality.
16092783|NCT02216110|Procedure|Surgery|Surgery for early gastric cancer includes distal gastrectomy, total gastrectomy, proximal gastrectomy, and wedge resection
16092784|NCT02216097|Drug|PF-04457845|4mg PF-04457845 tablet taken once daily for 7 days.
16092785|NCT02216097|Drug|Placebo|Matching placebo tablet taken once daily for 7 days.
16092786|NCT02216084|Drug|Recombinant ADAMTS13|"rADAMTS13 (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13) is a lyophilized formulation for intravenous injection. The lyophilized rADAMTS13 is reconstituted with sterile water for injection.
~Subjects will receive an intravenous injection with rADAMTS13 at a dose of either 5 U/kg bodyweight (Cohort 1), or 20 U/kg bodyweight (Cohort 2), or 40 U/kg bodyweight (Cohort 3)."
16092787|NCT02216071|Drug|Ciprodex®|Treatment of acute otitis externa (AOE) when administered twice daily for 7 days
16094273|NCT02205359|Device|aCRT OFF|CRT device with AdaptivCRT disabled
16092788|NCT02216071|Drug|EXL CDOS (Ciprofloxacin 0.3% and Dexamethasone 0.1%) Sterile Otic Suspension|Treatment of acute otitis externa (AOE) when administered twice daily for 7 days
16092789|NCT02216058|Device|NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System|
16092790|NCT02216045|Drug|Peginterferon, Ribavirin, camel milk|"Peginterferon One subcutaneous injection containing 0.5 ml solution with180 mcg PegIFNα-2a per week for 12 weeks.
~Ribavirin (RBV) tablets (body-weight adjusted dose: < 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for for 12 weeks .
~camel milk 250 ml of raw camel milk will be consumed in 10 minutes orally twice daily for 12 weeks."
16092791|NCT02216045|Drug|Peginterferon, Ribavirin|"Peginterferon (PegIFNα-2a) One subcutaneous injection containing 0.5 ml solution with180 mcg PegIFNα-2a per week for 12 weeks.
~Ribavirin (RBV) tablets (body-weight adjusted dose: < 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for for 12 weeks."
16092792|NCT02216032|Other|TMW Curriculum|
16092793|NCT02216032|Other|Nutrition Curriculum|
16092794|NCT02216019|Other|Whole blood|preoparatoire whole blood and postoperative whole blood
16092795|NCT02216006|Procedure|Control group, conventional ventilatory settings|"Handling of the airway during induction and intubation is performed in a conventional manner.
~Initial ventilatory settings are also done in a conventional manner. As soon as correct position of the endotracheal tube is confirmed, controlled ventilation is started with a tidal volume of 7 mL/kg ideal body weight, PEEP 6 or 8 cm H2O (8 if BMI >25) and a respiratory frequency of 10. The fresh gas flow is set to 1 Liter per minute with an oxygen mixture of 40%, aiming for an inspired FiO2 of 30-35%.
~Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure."
16092796|NCT02216006|Procedure|High fresh gas flow, high minute ventilation|"Handling of the airway during induction and intubation is performed in a conventional manner.
~Immediately after confirming a successful intubation, the effect of preoxygenation is eliminated with a fresh gas flow of 10 L/min of air, delivered with volume controlled ventilation consisting of tidal volumes of approximately 15 ml/kg ideal body weight, a positive expiratory pressure of 10 cm H20 and a respiratory frequency of 10. As soon as the end tidal O2 reaches 25%, the ventilator settings are adjusted to normal values (same as in the control group), i.e. tidal volume 7 mL/kg ideal body weight, PEEP 6 or 8 cm H2O (8 if BMI >25). The mixture of oxygen in the fresh gas is increased to 40% and the fresh gas flow is set to 1 Liter per minute, aiming for an inspired FiO2 of 30-35%.
~Unless the patient´s SpO2 falls below 90%, the FiO2 remains unchanged throughout the procedure."
16092797|NCT02215993|Drug|Prasugrel|After 8 to 6 hours after the dose of 300mg and 600mg respectively. Patients will be randomized in a 1:1 ratio to receive ticagrelor the dose of 180mg and maintained dose of 90 mg twice a day for thirty days or prasugrel dose of 60mg and maintained for thirty days at a daily dose of 10mg.
16092798|NCT02215993|Drug|Ticagrelor|After 8 to 6 hours after the dose of 300mg and 600mg respectively. Patients will be randomized in a 1:1 ratio to receive ticagrelor the dose of 180mg and maintained dose of 90 mg twice a day for thirty days or prasugrel dose of 60mg and maintained for thirty days at a daily dose of 10mg.
16092799|NCT02215980|Drug|Lenalidomide|
16092800|NCT02215980|Drug|Dexamethasone|
16092801|NCT02215967|Drug|Cyclophosphamide|300 mg/m^2 intravenous (IV) over 30 minutes on days -5, -4, and -3
16092802|NCT02215967|Drug|Fludarabine|30 mg/m^2 intravenous (IV) over 30 minutes immediately following the cyclophosphamide on day -5, -4, and -3
16092803|NCT02215967|Biological|Anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T cells|0.3x10^6- 15.0x10^6 CAR+ T cells per kg of recipient bodyweight one time dose on day 0
16092804|NCT02215954|Drug|FE 999169|FE 999169 is a white crystalline powder for oral solution. Each sachet (16.1 g) contains sodium picosulfate hydrate 10 mg, magnesium oxide 3.5 g and anhydrous citric acid 12 g as well as orange flavour, potassium bicarbonate and sodium saccharin as excipients. FE 999916 is dissolved by mixing the contents of the sachet with approximately 150mL of cold water in a cup before administration.
16092805|NCT02215954|Drug|Niflec|Niflec is a white-yellowish powder for oral solution. Each plastic sachet (137.155 g) contains sodium chloride 2.93 g, potassium chloride 1.485 g, sodium bicarbonate 3.37 g and sodium sulfate anhydrous 11.37 g, as well as macrogol 4000, saccharin sodium hydrate, flavour as excipients. Niflec is dissolved in water to make approximately 2 L of solution before administration.
16092806|NCT02215941|Drug|TV-45070|TV-45070 8% ointment
16092807|NCT02215941|Drug|Placebo|Placebo
16092808|NCT02215928|Genetic|mutation analysis|Correlative studies
16092809|NCT02215928|Other|cytology specimen collection procedure|Correlative studies
16092810|NCT02215928|Other|laboratory biomarker analysis|Correlative studies
16092811|NCT02215915|Procedure|Angiography|The size and number of stents and post-dilation will be determined on physician's discrete within the range allowed in this study protocol. All procedure will be performed according to current standard technique. Additional stent implantation or post dilation will be allowed according to attending physician's discrete. IVUS will be not used in this arm.
16092812|NCT02215915|Procedure|IVUS|The size and number of stents and post-dilation will be determined on physician's discrete within the range allowed in this study protocol. All procedure will be performed according to current standard technique. IVUS will be used to assess the anatomic characteristics of lesion and determine appropriate stent size and length. Additional stent implantation or post dilation will be allowed according to attending physician's discrete based on IVUS results.
16092813|NCT02215915|Procedure|DES implantation|
16092814|NCT02215902|Device|Affinity plasmapheresis|Insert investigational affinity plasma filter into hemodialysis circuit during routine hemodialysis treatments.
16092815|NCT02215889|Procedure|Liver transplantation|
16092816|NCT02215876|Drug|Doxorubicin|Doxorubicin 60mg/m2 administered intravenously over 5 minutes on day 1 of a 14 of 21 days cycle IV for 4 cycles
16092817|NCT02215876|Drug|Cyclophosphamide|Cyclophosphamide 600mg/m2 administered intravenously over 60 minutes on day 1 of a 14 of 21 days cycle IV for 4 cycles
16092818|NCT02215876|Drug|Eribulin|Eribulin 1.4 mg/m2 administered intravenously over 2-5 minutes on days 1 and 8 of a 21 day cycle for 4 cycles
16092819|NCT02215863|Biological|Fluad and Prevenar13|
16092820|NCT02215863|Biological|Fluad|
16092821|NCT02215863|Biological|Prevenar13|
16092822|NCT02215850|Drug|SLC-0111|
16093039|NCT02214290|Drug|Placebo|A 750 mg placebo capsule (maltodextrin) was given to subjects to examine the effect of the drug on arterial function.
16092823|NCT02215837|Drug|Chemotherapy|Oxaliplatin 85mg/m2 IV over 2 hours, day 1; Leucovorin 400mg/m2 IV over 2 hours, day 1; 5-FU 400mg/m2 IV bolus on day 1, then 1200mg/m2/day for 2 days IV continuous infusion; Repeat every 2 weeks.
16092824|NCT02215837|Biological|Ag-D-CIK|8×10^9 autologous tumor lysate pulsed D-CIK cells for each infusion, IV (in the vein) for 3 cycles, each cycle received four infusions on day 14, 16, 30 and 32.
16092825|NCT02215824|Drug|BIWH 3|
16092826|NCT02215824|Drug|Placebo|
16092827|NCT02215811|Biological|Mesenchymal stromal cells|
16092828|NCT02215798|Drug|Cymbalta|
16092829|NCT02215785|Other|Kiwifruit|Throughout the five-week study period the patient had to continue their normal eating habits and exercise regime.
16092830|NCT02215772|Drug|BI 44370 BS|
16092831|NCT02215759|Drug|BI 44370 TA|
16092832|NCT02215759|Drug|Placebo|
16092833|NCT02215746|Drug|BI 44370 powder for oral solution|
16092834|NCT02215746|Drug|BI 44370 tablet|
16092835|NCT02215746|Other|high fat breakfast|
16092836|NCT02215733|Drug|ARB|other than telmisartan
16092837|NCT02215733|Drug|ACEI|
16092838|NCT02215733|Drug|Beta-blockers|
16092839|NCT02215733|Drug|Diuretics|
16092840|NCT02215733|Drug|Telmisartan|
16092841|NCT02215720|Drug|Cetuximab|
16092842|NCT02215720|Drug|Temsirolimus|
16092843|NCT02215707|Biological|PfSPZ Vaccine|Suspension of metabolically active, non-replicating (live), radiation-attenuated, purified, cryopreserved, aseptic Plasmodium falciparum (Pf) sporozoites (SPZ)
16092844|NCT02215694|Dietary Supplement|dual probiotics|2g of powder daily containing dual probiotics(Lactobacillus curvatus HY7601 and Lactobacillus plantarum KY1032)
16092845|NCT02215694|Dietary Supplement|placebo|2g of powder daily without probiotics
16092846|NCT02215681|Device|acupuncture|
16092847|NCT02215668|Procedure|Physical exercise|Exercise muscle stretching and body warming.
16092848|NCT02215655|Behavioral|Motivational interviewing|Motivational interviewing counselling sessions will be administered to the subjects.
16092849|NCT02215629|Drug|VS-4718|
16092850|NCT02215616|Drug|Laquinimod|Laquinimod capsules will be administered as per the dose and schedule specified in the respective arms.
16092851|NCT02215616|Drug|Placebo|Matching laquinimod placebo will be administered as per the schedule specified in the respective arms.
16092852|NCT02215603|Behavioral|Breaking prolonged sitting with physical activity|
16092853|NCT02215590|Device|Re-Step|"Research Group:
~Each session begins with a warm-up exercise, muscle stretching, and strengthening exercises: duration 10 minutes.
~Afterwards, walking exercises for 40 minutes with Re-Step according to a program individually tailored and progressing with the training. Progress is shown by an increased range of tilting of the shoe and speed of changes, according to the individual ability of each patient.
~At the end of the session 10 min of cool-down exercises
~22 training sessions of 60 minutes each, twice a week."
16092854|NCT02215577|Procedure|In-situ split|The portal branches to the diseased side should be completely divided. The bile duct to the diseased side should not be divided. The parenchyma should be transected all the way through the transection plane and place a plastic sheet on the diseased transection surface.
16092855|NCT02215577|Procedure|Portal embolization or ligation|Portal vein embolization is performed according to the intervention used at the different sites.
16092856|NCT02215538|Drug|OROS methylphenidate|
16092857|NCT02215538|Drug|Placebo|Placebo medication appears identical to the active medication OROS methylphenidate
16092858|NCT02215525|Device|UVA|device uses UVA
16092859|NCT02215525|Dietary Supplement|Herbal|Herbal tablets, 1000 mg every 6 hours daily for 6 months
16092860|NCT02215512|Drug|RRx-001 + WBRT|Subjects will receive a combination of RRx-001 and whole brain radiotherapy.
16092861|NCT02215499|Drug|Placebo|
16092862|NCT02215499|Drug|Sodium Oxybate|
16092863|NCT02215499|Drug|JZP-386|
16092864|NCT02215486|Other|Head Massage Therapy|Intervention consists of administering head massage therapy according to the Chinese head massage protocol for approximately 10 minutes.
16092865|NCT02215486|Other|Simple relaxation (No Head Massage)|Consists of a simple relaxation in the same sitting position as the head massage therapy session.
16092866|NCT02215473|Drug|Chlorhexidine gluconate mouth rinse|Before local oral anesthesia and periodontal instrumentation individuals performed a single oral rinse (15mL of 0.12% chlorhexidine gluconate for 30 seconds). Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.
16092867|NCT02215473|Procedure|Periodontal instrumentation|Individuals only received local oral anesthesia before periodontal instrumentation. Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.
16092868|NCT02215460|Procedure|FMS full-mouth scaling|Participants received oral hygiene instructions and full-mouth scaling within 24 hours. Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.
16092869|NCT02215460|Procedure|QS quadrant scaling|Participants received oral hygiene instructions and quadrant scaling in 4 weekly sections. Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.
16092870|NCT02215460|Drug|FMS chlorhexidine rinse|Participants received oral hygiene instructions and full-mouth scaling within 24 hours followed by a 60-day use of 0.12% chlorhexidine mouth rinse (15mL/30 seconds/ 2 times a day). Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.
16092871|NCT02215460|Drug|FMS placebo rinse|Participants received oral hygiene instructions and full-mouth scaling within 24 hours followed by a 60-day use of placebo mouth rinse (15mL/30 seconds/ 2 times a day). Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.
16092872|NCT02215460|Drug|FMS azithromycin tablets|Participants received oral hygiene instructions and full-mouth scaling within 24 hours followed by a 3-day use of azithromycin tablets (1 tablet/day). Debridement procedures were carried out Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.
16093040|NCT02214290|Dietary Supplement|L-citrulline|L-citrulline was used to examine the effect of the supplement on arterial function.
16092873|NCT02215460|Drug|FMS placebo tablets|Participants received oral hygiene instructions and full-mouth scaling within 24 hours followed by a 3-day use of placebo tablets (1 tablet/day). Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.
16092874|NCT02215460|Drug|QS azithromycin tablets|Participants received oral hygiene instructions and full-mouth scaling in 4 weekly sections followed by a 3-day use of azithromycin tablets (1 tablet/day). Debridement procedures were carried out Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.
16092875|NCT02215460|Drug|QS placebo tablets|Participants received oral hygiene instructions and full-mouth scaling in 4 weekly sections followed by a 3-day use of placebo tablets (1 tablet/day). Debridement procedures were carried out Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.
16092876|NCT02215460|Drug|QS chlorhexidine rinse|Participants received oral hygiene instructions and full-mouth scaling in 4 weekly sections followed by a 60-day use of 0.12% chlorhexidine mouth rinse (15mL/30 seconds/2 times a day). Debridement procedures were carried out Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.
16092877|NCT02215460|Drug|QS placebo rinse|Participants received oral hygiene instructions and full-mouth scaling in 4 weekly sections followed by a 60-day use of 0.12% placebo mouth rinse (15mL/30 seconds/2 times a day). Debridement procedures were carried out Debridement procedures were carried out under local anesthesia with manual Gracey and McCall curettes and Hirschfield files.
16092878|NCT02215447|Drug|NAB paclitaxel|100 mg/m2 i.v. every week (d1,8,15) in three weekly cycle Number of Cycles: until progression or unacceptable toxicity develops.
16092879|NCT02215447|Drug|Carboplatin|
16092880|NCT02215434|Drug|Biolipid B2 (blanked/placebo)|the intervention will be the comparison effects of both emulsions
16092881|NCT02215434|Drug|Testosterone, Transdermal, Behavior|Transdermal 0.5% testosterone Biolipid/B2
16092882|NCT02215421|Behavioral|Mommio|"The objective is to build parent's skills in encouraging their child to eat vegetables. The player is asked to read a novella, Totally Frobisher (providing backstory to the game), and play a game called Mommio (a casual video game for parents of 3 to 5 year old children). The player calls Kiddio, the child character, to dinner, and offers a vegetable (V) (selected from among several). Kiddio refuses. The player is offered a selection of V parenting statements (from the scientific literature on food parenting) or manipulation of the environment (e.g. turning off the kitchen TV) to control the situation and encourage the child to eat the V. As problems arise (e.g. a permissive father saying he doesn't like vegetables), the player must select ways to cope. Players set a goal to do with their child at home what they learned in the game. Game episodes include food store shopping, eating in the car, at grandma's, and at a fast food store."
16092883|NCT02215408|Behavioral|CVRS Intervention|A clinical pharmacist working in the University of Iowa CVRS followed each patient for 12 months, working on lifestyle modification and recommending medication changes to the patient's clinical pharmacist in the local clinic.
16092884|NCT02215395|Drug|NES/EE CVR|Concurrent administration of vaginal antimycotic medication (Miconazole Nitrate) on the pharmacokinetics of Nestorone (NES) and ethinyl estradiol (EE) delivered by a contraceptive vaginal ring (CVR)
16092885|NCT02215382|Drug|sugammadex|sugammadex 2 mg/kg
16092886|NCT02215382|Drug|neostigmine+atropine|neostigmine 0,05 mg/kg + atropine 0,025 mg/kg
16092887|NCT02215369|Device|VenaCure EVLT 400 µm fiber Procedure Kit|The study intervention will be conducted according to the DFU included with the VenaCure EVLT 400 µm fiber Procedure Kit.
16092888|NCT02215356|Drug|Icotinib with concurrent radiotherapy|Icotinib: 125 mg is administered orally three times per day.
16092889|NCT02215356|Drug|Chemoradiotherapy|Etoposide 50mg/m2, ivgtt, d1-d5; cisplatin 50mg/m2, ivgtt, d1 and d8, every 28 days for a cycle, a total of 2 cycles
16092890|NCT02215343|Dietary Supplement|Wheat bran extract|Patients will be provided with 15g of wheat bran extract (WBE) (Cargill R&D Centre Europe).
16092891|NCT02215343|Dietary Supplement|Fish oil|Patients will be provided with a fish oil supplement (capsules), containing 3-4g of N-3 fatty acids (Axellus A/S, Ishøj, Denmark).
16092892|NCT02215330|Drug|Eplerenone|
16092893|NCT02215330|Drug|Maltodextrin|
16092894|NCT02215304|Dietary Supplement|Bifidobacterium longum ssp infantis R0033|"12 weeks intervention study: A run-in period of two weeks, 8 weeks of intervention (from weeks 2 to 10) and two weeks after intervention finishing time.
~During the 8 weeks of intervention participants will intake one daily dose of the product which contains 3*10E9 colony forming units (CFU)"
16092895|NCT02215304|Dietary Supplement|Lactobacillus helveticus R0052|"12 weeks intervention study: A run-in period of two weeks, 8 weeks of intervention (from weeks 2 to 10) and two weeks after intervention finishing time.
~During the 8 weeks of intervention participants will intake one daily dose of the product which contains 3*10E9 colony forming units (CFU)"
16092896|NCT02215304|Dietary Supplement|Bifidobacterium bifidum R0071|"12 weeks intervention study: A run-in period of two weeks, 8 weeks of intervention (from weeks 2 to 10) and two weeks after intervention finishing time.
~During the 8 weeks of intervention participants will intake one daily dose of the product which contains 3*10E9 colony forming units (CFU)"
16092897|NCT02215304|Dietary Supplement|Placebo|"12 weeks intervention study: A run-in period of two weeks, 8 weeks of intervention (from weeks 2 to 10) and two weeks after intervention finishing time.
~During the 8 weeks of intervention participants will intake one daily dose of the product which contains 3*10E9 colony forming units (CFU)"
16092898|NCT02215278|Dietary Supplement|10 x 55 g/ bean per arm|
16092899|NCT02215265|Drug|Cisplatin|Chemotherapy
16092900|NCT02215265|Radiation|Postoperative radiotherapy|Postoperative radiotherapy (PORT)
16092901|NCT02215252|Drug|PF-05089771 150 mg|PF-05089771 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.
16092902|NCT02215252|Drug|Matched placebo for PF-05089771 150 mg and pregabalin 300 mg|Matched placebo for PF-05089771 150 mg twice daily and pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.
16092903|NCT02215252|Drug|Pregabalin 300 mg|Pregabalin 150 mg twice daily oral dosing with capsules. Treatment period = 4 weeks.
16092904|NCT02215252|Drug|PF-05089771 150 mg + Pregabalin 300 mg|PF-05089771 150 mg twice daily oral capsules with pregabalin 150 mg twice daily oral capsules. Treatment period = 4 weeks.
16094316|NCT02205060|Other|cognitive and behavioral approaches therapy|
16092905|NCT02215239|Behavioral|Workplace intervention|WHO Healthy Workplace Framework and Model. The intervention plan is to implement a cyclic or iterative process recommended by WHO. The process includes eight steps: (1) Mobilize; (2) Assemble; (3) Assess; (4) Prioritize; (5) Plan; (6) Do; (7) Evaluate; (8) Improve. We focus on different phases of exercise and prescribe individualized physical activity program.
16092906|NCT02215213|Drug|Vitamin D supplement|comparison of different dosages of vitamin D
16092907|NCT02215213|Drug|Vitamin D supplement|comparison of different dosages of vitamin D Supplement
16092908|NCT02215200|Drug|Anti-Thymocyte Globulin (ATG)|Thymoglobulin
16092909|NCT02215200|Drug|Granulocyte colony stimulating factor (GCSF)|Granulocyte colony stimulating factor (GCSF)
16092910|NCT02215200|Drug|Placebo (for ATG)|Normal saline administered by IV infusion to mimic ATG
16092911|NCT02215200|Drug|Placebo (for GCSF)|Placebo prepared to mimic 6mg subcutaneous injection of GCSF
16092912|NCT02215187|Behavioral|Problem-Solving Training (PST)|Training in problem-solving skills to be applied to military caregiver problems.
16092913|NCT02215187|Behavioral|Attention Control|Social contact control (health education/no skill training)
16092914|NCT02215174|Drug|Rosuvastatin|Rosuvastatin 20mg po x1
16092915|NCT02215161|Drug|Selinexor|Given PO
16092916|NCT02215148|Drug|Tolvaptan|
16092917|NCT02215135|Drug|Corifollitropin alfa|In GnRH antagonist protocol, ovarian stimulation with single dose of 100μg (BW≦60 kg) or 150μg (BW> 60 kg) corifollitropin alfa (Elonva, SC), followed 1 week later (stimulation day 8) by a daily dose of rFSH to the day of GnRH agonist triggering final oocyte maturation.
16092918|NCT02215122|Drug|MGR001|Fluticasone Propionate is an inhaled corticosteroid (ICS) Salmeterol is a long acting β2 agonist (LABA)
16092919|NCT02215122|Drug|Advair® Diskus®|Fluticasone Propionate is an inhaled corticosteroid (ICS) Salmeterol is a long acting β2 agonist (LABA)
16092920|NCT02215122|Drug|Seretide™ Accuhaler™|Fluticasone Propionate is an inhaled corticosteroid (ICS) Salmeterol is a long acting β2 agonist (LABA)
16092921|NCT02215096|Drug|GSK2636771|GSK is available as 100 mg hard gelatin oral capsule to be taken once daily/continuous until treatment withdrawal under fasting conditions for at least 1hour (h) before and 2h after dosing with approximately 200 mL of water
16092922|NCT02215096|Drug|Enzalutamide|Enzalutamide will be sourced locally from commercial stock for sites in countries where it is approved
16092923|NCT02215083|Dietary Supplement|L-glutamine|10,000mg by mouth, twice daily for nine weeks (± 7 days) with one permitted dose escalation to a maximum of 10,000mg by mouth three times daily.
16092924|NCT02215070|Drug|Pasireotide|Eligible subjects will receive pasireotide daily for 5 days before stem cell transplant, the day of the stem cell transplant, and daily for 8 days following the stem cell transplant. Preparatory regimen will be given 4 days before stem cell transplant.
16092925|NCT02215057|Drug|topical anesthesia|topical anesthetic drops and Group 2
16092926|NCT02215057|Drug|topical anesthesia plus intracameral lidocaine 1%|received topical anesthesia plus intracameral lidocaine 1%
16092927|NCT02215044|Drug|BI 2536, intravenous|
16092928|NCT02215044|Drug|Gemcitabine, intravenous|
16092929|NCT02215031|Drug|BI 44370|
16092930|NCT02215031|Drug|Placebo|
16092931|NCT02215018|Drug|BI 44370 TA solution|
16092932|NCT02215018|Drug|BI 44370 TA tablet|
16092933|NCT02215018|Drug|Placebo solution|
16092934|NCT02215018|Drug|Placebo tablet|
16092935|NCT02215005|Drug|Telmisartan|
16092936|NCT02215005|Drug|Ramipril|
16092937|NCT02214992|Drug|Telmisartan/Ramipril|Fixed dose combination tablet
16092938|NCT02214992|Drug|Telmisartan|
16092939|NCT02214992|Drug|Ramipril capsule|
16092940|NCT02214992|Drug|Ramipril tablet|
16092941|NCT02214979|Drug|Telmisartan/Ramipril|fixed dose combination tablet
16092942|NCT02214979|Drug|Telmisartan|
16092943|NCT02214979|Drug|Ramipril capsule|
16092944|NCT02214979|Drug|Ramipril tablet|
16092945|NCT02214966|Drug|Telmisartan/Ramipril, fixed dose combination tablet|
16092946|NCT02214966|Other|high fat, high caloric meal|
16092947|NCT02214953|Drug|BI 11634 ER formulation A|
16092948|NCT02214953|Drug|BI 11634 ER formulation B|
16092949|NCT02214953|Drug|BI 11634 ER formulation M|
16092950|NCT02214953|Drug|BI 11634 ER formulation C|
16092951|NCT02214953|Drug|BI 11634 IR tablet|
16092952|NCT02214940|Drug|BI 11634|
16092953|NCT02214940|Drug|Placebo|
16092954|NCT02214927|Drug|BI 11634 tablet|
16092955|NCT02214927|Drug|BI 11634 drinking solution|
16092956|NCT02214914|Drug|BI 11634 drinking solution|
16092957|NCT02214914|Drug|BI 11634 tablet|
16092958|NCT02214914|Drug|Placebo|
16092959|NCT02214901|Drug|BIBW 2948 BS for oral inhalation|
16092960|NCT02214901|Drug|Placebo|
16092961|NCT02214888|Drug|BIRB 796 BS, low dose|
16092962|NCT02214888|Drug|BIRB 796 BS, high dose|
16092963|NCT02214888|Drug|Placebo|
16092964|NCT02214875|Other|CQI/BTS|Application of CQI/BTS interventions through employing rapid structured cycles of data collection, testing of solutions and review of changes will be implemented. At each site a Quality Improvement Team (QIT) will be established from among the facility staff. Local Government and State level QI teams will provide oversight function of the health facilities' QI initiatives. BTS as a collaborative learning approach will be conducted quarterly in each study state at a central location with participants from the intervention sites. The sessions will provide opportunity for teams to learn from each other and to adapt and implement changes using the Plan-Do-Study-Act (PDSA) model.
16092965|NCT02214875|Other|Control|Facilities in control will continue will routine unstructured, irregular continuous quality improvement. Break Through Collaborative will not be applied to the control facilities.
16092966|NCT02214862|Drug|[F18]-FDDNP|radiopharmaceutical tracer
16092967|NCT02214849|Behavioral|LATCH Intervention|
16092968|NCT02214836|Device|Verasonics Data Acquisition System (VDAS)|Subjects will be imaged the Verasonics Data Acquisition System (VDAS) using conventional clinical outputs within FDA limits. The image processing has been modified. Stone location and size will be determined and compared to clinical determination of stone location and size.
16092970|NCT02214823|Other|Standard Care|standard care physiotherapy including respiratory and rehabilitation with mobilisation activities such as sitting out of bed, marching on the spot, and mobility training.
16092971|NCT02214810|Drug|Bupivacaine/Exparel|The opaque envelope, which was selected by the treating physician, will accompany each of the study participants will be opened and the patient identified as belonging to either Group 1 or Group 2. It is important to note that randomization of the envelopes were computer-generated and placed by a co-investigator; the treating physician is completely unaware of the order of the opaque envelopes. Patients in Group 1 will receive a standardized medication regimen including non-liposomal bupivacaine by soft-tissue injection at the conclusion of their surgical procedure. Those in Group 2 will receive non-liposomal bupivacaine and ExparelTM by soft-tissue injection at the conclusion of their surgical procedure. Study participants will undergo injection in this manner until the conclusion of the study.
16092972|NCT02214797|Device|Etafilcon A, Lotrafilcon B , Senofilcon A|
16092973|NCT02214784|Device|Active Neurotech Vital|12 weeks treatment for 30 minutes per day, 5 days out of 7.
16092974|NCT02214784|Device|Modified Neurotech Vital Device|12 weeks treatment for 30 minutes per day for 5 days out of 7.
16092975|NCT02214771|Drug|Fidaxomicin|oral
16092976|NCT02214771|Drug|Treatment for CDI other than fidaxomicin Type|Oral
16092977|NCT02214758|Other|Nutrition and oral health interventions|On the basis of a blood test, Mini Nutritional Assessment, and nutritional anamnesis, the nutritionist developed a plan for individualised nutritional care and discussed with the participant and her/his nurse or family members. If the participants seemed unable to increase the energy and/or protein of their diet, daily complementary dietary drinks were recommended to them. After the dental hygienist interview and oral health examination, the participants in need were targeted for oral health intervention. The intervention included individualised instructions on either dental hygiene, denture hygiene, cleaning of the oral mucosa or for dry mouth. The participants were re-examined six months after the baseline interviews to evaluate the effectiveness of the interventions. Both the intervention and control groups had the same examinations as with the exception of the nutritional and oral health intervention.
16092978|NCT02214745|Other|Questionnaire|Questionnaire developed for this purpose by the investigators
16092979|NCT02214732|Behavioral|Mindfulness Based Cognitive Therapy|The modified MBCT program for pregnant women is an 8-session group intervention that aims to help women change their relationship to the thoughts, feelings, and bodily sensations that can lead to psychological distress. Participants are guided to recognize and disengage from unhelpful mind states characterized by self-perpetuating patterns of ruminative thought. The intervention was modified to address pregnant women's physical and emotional needs, as well as their risk of perinatal mood episodes.
16092980|NCT02214719|Behavioral|EASI-IDM use|EASI-IDM use is the intervention involving the use of the Edmonton Automated Sugar Intelligence system linked to the Intelligent Diabetes Website by people with type 1 diabetes to facilitate glucose record keeping, clinical monitoring and we will assess if this app helps lead to improved glucose control and more patient involvement with their diabetes management.
16092981|NCT02214706|Drug|Sirolimus|sirolimus (40 µl) will be applied under occlusion, using van der Bend patch-test chambers (size: 1cm2), and left in situ for 7 days.
16092982|NCT02214706|Other|Erbium yag laser|Er:Yag laser ablation of the stratum corneum
16092983|NCT02214706|Device|Pulsed Dye Laser|
16092984|NCT02214693|Drug|DA-1229|
16092985|NCT02214680|Drug|Combigan (Combination of Brimonidine and Timolol)|On the first exam the subject will receive Combigan (Combination of Brimonidine and Timolol) eye drop to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops. On the second exam the subject will receive Timolol (0.5%) eye drop to the right eye and a Brimonidine drop to the left eye. The effect on pupil size before and 30 minutes, 60 minutes, 240 minutes, and 300 minutes after instillation of eyedrops.
16092986|NCT02214680|Drug|Timolol|0.5% eye drop
16092987|NCT02214667|Behavioral|Dual-diagnosis motivational interviewing (DDMI)|DDMI is an evidence-based adaptation to motivational interviewing. DDMI incorporates an integrated framework and accommodates cognitive impairments and disordered thinking associated with co-occurring substance use and mental disorders.
16092988|NCT02214667|Behavioral|Integrated group therapy (IGT)|IGT is an evidence-based practice for treating co-occurring disorders. IGT focuses on relapse prevention by reducing substance use and stabilizing psychiatric symptoms.
16092989|NCT02214667|Behavioral|Jail and community-based behavioral health services|Existing behavioral health service programs
16092990|NCT02214641|Behavioral|Resilient, Empowered, Active Living with Diabetes|Individualized lifestyle intervention incorporating the following topics: Diabetes knowledge; access to healthcare; communication with healthcare providers; incorporation of diabetes self-care tasks within daily habits and routines; social support; and emotional well-being. Participants receive a total of 10-16 hours of intervention by a licensed occupational therapist with training in diabetes education, motivational interviewing and the REAL Diabetes intervention protocol.
16092991|NCT02214641|Behavioral|Information Control|Participants will receive a packet of informational materials about diabetes, and receive periodic follow-up phone calls to match for attention dose. The packet of materials will be delivered in an initial home visit. Follow-up phone calls will occur at approximately two week intervals to inquire whether participants have reviewed specific sections of the intervention materials, and clarify information included in the packet.
16092992|NCT02214628|Drug|Fovista® (anti-PDGF BB) plus anti-VEGF|
16092993|NCT02214615|Drug|Carbamazepine|"Day 1: Take 200 mg twice a day. Day 2: Take 200 mg twice a day. Day 3: Take 200 mg twice a day. Day 4: Take 200 mg twice a day. Day 5: Take 400 mg twice a day. Day 6: Take 400 mg twice a day. Day 7: Take 400 mg twice a day. Day 8: Take 400 mg twice a day. Day 9: Take 600 mg twice a day. Day 10: Take 600 mg twice a day. Day 11: Take 600 mg twice a day. Day 12: Take 600 mg twice a day. Day 13: Take 800 mg capsules twice a day. Day 14: Take 800 mg twice a day. Day 15: 800 mg twice a day. Day 16: Take 800 mg twice a day.
~Taper Down (After Visit 4 and 7) If maximal dose of 800 mg/day has been achieved, tapering down will take 9 days Taper down for 600 mg/day will take 6 days, and for 400 mg/day will take 3 days."
16092994|NCT02214615|Drug|Placebo|
16093035|NCT02214329|Device|Sensor-based exercise training|Body-worn sensors are mounted on different body segments to acquire joint kinematic data and provide real-time joint feedback during exercise training.
16092995|NCT02214602|Drug|Epirubicin|"Experimental: Study group(Epirubicin)
~in the arm -study group(Epirubicin)- : patients will receive immediate intravesical instillation of 50 mg of epirubicin in 50 ml of saline 0.9 % after 30 min after compete transurethral resection of bladder tumor"
16092996|NCT02214589|Other|Oral glucose, facilitated tucking, NNS|
16092997|NCT02214589|Other|Oral glucose and NNS|
16092998|NCT02214589|Other|Facilitated tucking and NNS|
16092999|NCT02214563|Dietary Supplement|Cholecalciferol|Made for this trial by Molecular Physiological Chemistry Laboratory, Inc.
16093000|NCT02214563|Dietary Supplement|Olive oil|
16093001|NCT02214550|Drug|microgestin 1/20|"Cyclic OC Use - Participants will ingest pills containing active hormones for 21 days followed by 7 days of no pills, and then the cycle will repeat
~Continuous OC use - Pills containing hormones will be taken every day for 1 year"
16093002|NCT02214537|Other|MACS|
16093003|NCT02214524|Device|Bair Hugger forced air warming system|Bair Hugger Model 775 temperature management unit-offers two airflow settings, hose-end temperature sensing, and precise temperature delivery
16093004|NCT02214511|Behavioral|emotional facial stimuli|Subjects watch passively dynamic facial emotions obtained by emotionnal faces photos morphing. Their rapid facial reactions are recorded by faciel EMG device as eye movement by occulometric device.
16093005|NCT02214511|Behavioral|Cyberball game|Ball tossing computer game to manipulate social inclusion status : rejection or inclusion. Social behavior, social pain and inflammatory modification will be assessed after the game.
16093006|NCT02214498|Drug|Enalapril/hydrochlorothiazide|The intervention implies that morning and evening administration of enalapril/hydrochlorothiazide will be compared
16093007|NCT02214498|Drug|Placebo|
16093008|NCT02214485|Behavioral|integrated care|Participants visit the study site with health education, social activities, warm up, stretch, and low intensity resistance exercise for about 1 hour per week. If any medical problems or functional decline suspected during the visit, the case manager refers participants to their primary care physicians for further managements.
16093009|NCT02214485|Behavioral|lower extremity strength training|Participants receive 2 sessions of 30-minute lower extremity strength straining using isotonic strength training machines each week. The intensity is set at 60-80% of 1 repetition maximum (RM). Evaluation of the exercise protocol are repeated every 2 weeks for individualized adjustments.
16093010|NCT02214472|Behavioral|Biofeedback|
16093011|NCT02214472|Drug|Placebo|
16093012|NCT02214459|Behavioral|DASH Mobile mhealth enhanced coaching|Phone calls with a health coach that utilize the tracking data collected by the app and devices.
16093013|NCT02214433|Drug|Placebo IV Solution|A sterile IV solution of 5% dextrose in water
16093014|NCT02214433|Drug|Debio 1450 IV Solution|A white to off-white powder (40 mg Debio 1450 per vial) to be reconstituted and formulated in a sterile IV solution of 5% dextrose in water
16093015|NCT02214433|Drug|Placebo Tablet or Capsule|Placebo tablet or capsule, matching Debio 1450 coated tablet or capsule
16093016|NCT02214433|Drug|Debio 1450 Tablet|Debio 1450 40 mg coated tablets
16093017|NCT02214433|Drug|Debio 1450 Capsule|Debio 1450 40 mg capsules
16093018|NCT02214433|Drug|Debio 1450 Oral Solution|Lyophilized Debio 1450 (40 mg per vial) reconstituted in 5% dextrose in water
16093019|NCT02214433|Drug|Pantoprazole|Pantoprazole 40 mg orally
16093020|NCT02214420|Drug|Simeprevir|
16093021|NCT02214420|Drug|Sofosbuvir|
16093022|NCT02214420|Drug|Ribavirin|
16093023|NCT02214407|Drug|Decitabine|"Decitabine (DAC) will be administered at 20 mg/m2 intravenously daily for 5 days every 28 days. Hydroxyurea may be added during the first 3 cycles if WBC counts > 30 G/L, and mandatory if WBC > 50 G/L. The daily dose will be adapted to maintain WBC below 15 to 20 G/L.
~Treatment will be continued until an event is reached. Events and thus study exit will be acknowledged only after agreement between the investigator and a Trial Committee."
16093024|NCT02214407|Drug|HYDROXYUREA|"Hydroxyurea (HY) 1g/d once daily, with dose adjustments (up to 4g/d) to maintain a WBC count between 5 and 10 G/L. Allopurinol, 300mg/d started at the time of inclusion will be administered to all patients.
~Treatment will be continued until an event is reached. Events and thus study exit will be acknowledged only after agreement between the investigator and a Trial Committee."
16093025|NCT02214394|Other|High-performance liquid chromatography Analysis|Blood samples will be collected for HPLC analysis to compare with the breath samples.
16093026|NCT02214394|Device|SMART Device|Breath collection for GC-MS analysis to compare with Blood collection.
16093027|NCT02214381|Drug|Myocet|
16093028|NCT02214381|Drug|Cyclophosphamide|
16093029|NCT02214381|Drug|Paclitaxel|
16093030|NCT02214368|Other|Early application of NIV|"Device:BiPAP Vision.
~NIV bundle group : Early application of NIV(BiPAP Vision) in 1 h after randomization."
16093031|NCT02214368|Device|Fiberoptic bronchoscopy|Device:fiberoptic bronchoscopy. NIV bundle group :When patients were inability to spontaneously clear airways from excessive secretions during NIV, fiberoptic bronchoscopy (FBO) was used for suction of secretions.
16093032|NCT02214368|Drug|Propofol|"Drug:propofol.continuous perfusion of propofol (0.50-2.00 mg/kg/h).
~NIV bundle group :When patients showed intolerance or inadequate patient cooperation during the NIV session, they were sedated (Ramsay scale 2-3) by a continuous perfusion of propofol (0.50-2.00 mg/kg/h).
~In the conventional treatment group: No intervention."
16093033|NCT02214368|Other|Conventional application of NIV|Conventional treatment group:NIV(BiPAP Vision) was used, when patients failed the supplemental oxygen and met at least two of the following criteria:(1) severe respiratory distress with dyspnoea, respiratory rate>30breaths/min, and clinical signs suggestive of respiratory-muscle fatigue or increased respiratory effort (use of accessory respiratory muscles or paradoxical abdominal breathing, or intercostal indrawing), (2) respiratory acidosis (arterial pH of 7.35 or less with PaCO2 of 45 mm Hg or more) ;(3) arterial O2 saturation by pulse oximetry less than 90% or PaO2 less than 60 mm Hg at an FiO2> 0.5 or breathing at least 10 L/min oxygen.
16093034|NCT02214342|Other|Balance Training|"Experimental: Balance Training Balance training will be conducted individually two times per week for 4 weeks. Each training session will include virtual reality tasks such as ankle reaching and obstacle crossing using a virtual obstacle shown on a computer screen. Each session will last 30 - 45 minutes."
16093036|NCT02214329|Other|In-home balance training|The control group performs similar exercise as intervention without sensors and with no visual feedback from sensors.
16093041|NCT02214277|Device|Cerebral Protection System-The SENTINEL System with TAVR|Claret Medical Sentinel Cerebral Protection System is intended for use as an embolic protection system to contain and remove embolic material (thrombus/debris) that may enter the carotid arteries.
16093042|NCT02214277|Device|TAVR|
16093043|NCT02214264|Behavioral|Loving-Kindness meditation training|Participants undergo training for approximately 12 minutes. Training involves guided reflections and intentions related to feeling loving-kindness towards the self and others.
16093044|NCT02214264|Behavioral|Breath Awareness meditation training|Participants undergo training for approximately 12 minutes. Training involves guided awareness focused on sensations of breathing.
16093045|NCT02214264|Behavioral|Gratitude|Participants undergo training for approximately 12 minutes. Training involves reflections of gratitude for people, events, and things in one's life.
16093046|NCT02214264|Behavioral|Control|Participants will write and then think about the physical space in which they live (i.e., their home) for approximately 12 minutes.
16093047|NCT02214251|Device|PK-16CH EXG system|
16093048|NCT02214238|Device|PAP device|
16093049|NCT02214225|Biological|Quadrivalent Influenza Vaccine (QIV)|One 0.5 mL intramuscular dose into the deltoid muscle
16093050|NCT02214225|Biological|Trivalent Influenza Vaccine (TIV-1)|One 0.5 mL intramuscular dose into the deltoid muscle.
16093051|NCT02214225|Biological|Trivalent Influenza Vaccine (TIV-2)|One 0.5 mL intramuscular dose into the deltoid muscle.
16093052|NCT02214212|Device|Bright White Light (BWL)|The device emitting BWL will be placed 24 inches from the participant's face on a pre-measured table. The participant will spend 30 minutes with the eyes open in front of the device. This will occur each morning for 10 days.
16093053|NCT02214212|Device|Red Light (RL)|The device emitting RL will be placed 24 inches from the participant's face on a pre-measured table. The participant will spend 30 minutes with the eyes open in front of the device. This will occur each morning for 10 days.
16093054|NCT02214199|Other|Manipulative Therapy Techniques|
16093055|NCT02214199|Other|Home Exercises|
16093056|NCT02214186|Other|Restrictive Fluid Therapy|The intervention in this randomized clinical trial is fluid restriction during cesarean section. The restricted group will receive 250 mL of crystalloid during surgery.
16093057|NCT02214173|Dietary Supplement|rice bran arabinoxylan compound (RBAC)|2 capsules with 6 to 8 ounces of water 3 times per day (6 tablets total per day) for 6 months.
16093058|NCT02214173|Dietary Supplement|Placebo|2 capsules with 6 to 8 ounces of water 3 times per day (6 tablets total per day) for 6 months.
16093059|NCT02214160|Drug|UX007|Administered orally (PO) with food or by gastrostomy tube, at the target dose range of 25-35% of total calories.
16093060|NCT02214147|Drug|Alisertib|Alisertib will be supplied as enteric coated tablets.
16093061|NCT02214134|Genetic|Tumour markers testing|
16093062|NCT02214121|Drug|Ticagrelor Dose 1a + Dose 2a|Ticagrelor Dose 1a and ticagrelor Dose 2a single doses + 1 week ticagrelor repeated dosing followed by 4 weeks repeated dosing ticagrelor or placebo.
16093063|NCT02214121|Drug|Ticagrelor Dose 1b + Dose 2b|Ticagrelor Dose 1b and ticagrelor Dose 2b single doses + 1 week ticagrelor repeted dosing followed by 4 weeks repeated dosing ticagrelor or placebo.
16093064|NCT02214108|Other|Nintendo Wii|Tennis, box and bowling on Nintendo Wii, 3 hours per week.
16093065|NCT02214095|Drug|glucosamine sulphate|group I (G1) patients received 500 mg glucosamine sulphate capsules (Glucosamine Compound) , three times daily for 3 months following initial cause related therapy. Group II patients were given placebo capsules( Lactose) for the same period following initial cause related therapy
16093066|NCT02214095|Drug|lactose capsules|
16093067|NCT02214082|Other|Same Day Discharge|This group will be discharged home, on the same day after their elective angioplasty
16093068|NCT02214069|Device|Record and transmit heart rhythm|The patient uses the AliveCor device to record and transmit heart rhythm two times a day. The patient, device software, and Electrophysiologist interpret the rhythm
16093069|NCT02214056|Other|Patient recruitment|Participating general practitioners (GPs) will inform and recruit participants from among regular patient consults. Using the provided web tools, GPs will organize a visit with the mobile team that fits the needs of the patient.
16093070|NCT02214056|Procedure|Mobile team exam|"Each patient enrolled will receive a standardized assessment in one locality, made in about two hours, and comprising:
~questionnaire responses, a complete physical exam, a 12-lead ECG, spirometry before and after administration of β2-agonists, an arterial Doppler ultrasound (carotid and abdominal), ankle-brachial index (systolic pressure at the toe).
~At the end of two hours, each patient will evaluate their satisfaction using a survey of acceptability and leave with a full report to the attention of their general practitioner (copy sent to Physician if needed) detailing the results of the different examinations."
16093071|NCT02214030|Device|Assiut Femoral Compression Device|Assiut Femoral Compression Devices (AFCD) is a femoral compression system, The pressure dome is situated over the vessel puncture site in the groin and applies a mechanical pressure over the vessel puncture site to induce hemostasis.
16093072|NCT02214017|Device|A videotelephone, TandBerg E20,|
16093073|NCT02214017|Behavioral|Behavioral motivation|Optimization of medical care in diabetes
16093074|NCT02214004|Drug|Trastuzumab|"- Eight times IV administration of trastuzumab per 3 weeks
~Trastuzumab 8mg/kg on Day 1 of Cycle 1
~Trastuzumab 6mg/kg from Day 1 of Cycle 2 to Day 1 of Cycle 8"
16093075|NCT02214004|Drug|Letrozole|- Daily letrozole 2.5 mg/day for 24 weeks
16093076|NCT02213991|Device|Intraoperative radiotherapy using Intrabeam®|"Operation day
~Aftuer tumor lump is removed and negative tumor margins are achieved, applicator of Intrabeam® is located within tumor cavity.
~Purse string suture pulles up tissues and wraps up the applicator.
~Intraoperative radiotherapy using Intrabeam® (20Gy) is followed.
~After IORT, applicator was out of the operative field, and usual wound closure will be done.
~Postoperative period
~Chemotherapy WBRT (46 Gy) for 4~5 weeks
~Endocrine therapy or target therapy"
16093077|NCT02213965|Device|Peripheral IV catheter|Intravenous access according to Instructions For Use
16093164|NCT02213328|Drug|Truvada|Fixed-dose combination tablet containing 200 mg of FTC plus 300 mg of TDF, taken once daily by mouth.
16093165|NCT02213315|Drug|100mg Mavrilimumab|100mg Mavrilimumab
16093166|NCT02213315|Drug|150mg mavrilimumab|150mg mavrilmumab
16093167|NCT02213315|Other|Placebo|Placebo
16093168|NCT02213302|Drug|placebo administration|
16093078|NCT02213952|Drug|Platelet-Rich Plasma|For obtaining autologous PRP, will be drawn from 9-30 ml of blood of the patient in sterile tubes containing 4.5 ml of 3.8% sodium citrate. The tubes will be centrifuged for 8 min at 580 Gs to separate the different blood components according to density gradient. After centrifugation, we will aspire the PRP. We will add CaCl2 to the PRP (50l per ml of liquid plasma). While the plasma will get gelified, we will cure the ulcer with saline cleaning and mechanical removal. Then the ulcer will be covered with gelified PRP and a secondary dressing. This cure will be done each 7 days.
16093079|NCT02213952|Other|Usual treatment|Usual treatment: Patients in the control group will be treated according to Osakidetza recommendations of humid environment cure. The choice of material for the cure depends on the prior assessment of the wound and surrounding skin, appearance and amount of exudate and the presence or absence of signs of infection. These cures will be performed every 48-72 hours.
16093080|NCT02213926|Drug|ACP-196 (acalabrutinib)|
16093081|NCT02213913|Drug|lenalidomide|Given PO
16093082|NCT02213913|Drug|etoposide|Given IV
16093083|NCT02213913|Drug|prednisone|Given PO
16093084|NCT02213913|Drug|vincristine sulfate|Given IV
16093085|NCT02213913|Drug|doxorubicin hydrochloride|Given IV
16093086|NCT02213913|Drug|cyclophosphamide|Given IV
16093087|NCT02213913|Biological|rituximab|Given IV
16093088|NCT02213913|Other|quality-of-life assessment|Ancillary studies
16093089|NCT02213913|Other|laboratory biomarker analysis|Correlative studies
16093090|NCT02213900|Drug|Haloperidol|0.5mg IV Push immediately after surgery and Q8H following for a total of 4 days
16093091|NCT02213900|Drug|Placebo|
16093092|NCT02213887|Drug|Pantoprazole|40 mg PO QAM
16093093|NCT02213887|Drug|Pantoprazole|0 mg PO QAM
16093094|NCT02213874|Other|Questionnaire|A questionnaire will be administered during the early stages of prenatal care & again during the postpartum period. The initial questionnaire will assess trust in the health care system, locus of control, religiosity, health literacy & collect information about demographics, contraceptive & reproductive history, future pregnancy intentions, & baseline knowledge about contraception. The postpartum questionnaire will repeat questions about future pregnancy & contraception intentions, trust in the health care system, knowledge of contraception and collect new information about characteristics of antenatal contraceptive counseling received including whether a provider recommended a specific method of contraception, the amount of counseling received, & the type of counseling received.
16093095|NCT02213861|Drug|SHAPE|topical gel
16093096|NCT02213848|Drug|Calcium|Administration of calcium chloride 5 mg/kg along with neostigmine 25 mcg/kg + atropine 15 mcg/kg
16093097|NCT02213848|Drug|control|In the control group, all the procedures were the same with calcium group, except for the fact that calcium chloride is not administered
16093098|NCT02213835|Other|Specific Carbohydrate diet (SCD)|
16093099|NCT02213822|Other|Molecular Analysis of Cancer|The intervention performed in this study is the molecular analysis of cancer. Samples to be tested for genetic alterations will be collected during the course of a routine diagnostic procedure such as a surgery or tumor biopsy. Samples that have been stored from previous diagnostic procedures will be analyzed as well. This testing will be performed by the Department of Pathology at Rhode Island Hospital or an outside laboratory designated by Rhode Island Hospital. The extent of molecular testing will be different in each individual case. For example, in some cases, study of genetic alterations will start with whole genome or exome sequencing and will be confirmed by targeted Sanger resequencing, single nucleotide polymorphism, and transcriptome analysis. In other cases targeted multigene panel sequencing or targeted amplicon Sanger sequencing will be the initial and only step.
16093100|NCT02213809|Behavioral|Case method education in COPD|In case method a rich narrative describing of a real-life situation (teaching case) is presented, in which the learning group must make a decision or solve a problem. The teaching case provide information, but neither analysis nor conclusions. The analytical work of explaining the relationships among events in the case, identifying options, evaluating choices and predicting the effects of actions is the work done by students during the discussion.
16093101|NCT02213809|Behavioral|Traditional education in COPD|Traditional education in this study means that the teacher mainly speaks to the group. Although short cases may be used for illustration, the main focus is not that the group shall solve problems from a narrative case.
16093102|NCT02213796|Drug|Meropenem|
16093103|NCT02213783|Drug|Imipenem|Each patient will receive 0.5 g of imipenem, 0.5 hr infusion every 6 hr at room temperature
16093104|NCT02213783|Drug|Imipenem|Each patient will receive 0.5 g of imipenem, 4 hr infusion every 6 hr of at room temperature
16093105|NCT02213757|Drug|Premarin vaginal estrogen cream|
16093106|NCT02213757|Drug|Placebo vaginal cream|Inactive vaginal cream manufactured to mimic Premarin vaginal cream
16093107|NCT02213744|Drug|MM-302|
16093108|NCT02213744|Drug|Gemcitabine|
16093109|NCT02213744|Drug|Capecitabine|
16093110|NCT02213744|Drug|Vinorelbine|
16093111|NCT02213744|Drug|Trastuzumab|
16093112|NCT02213731|Other|Holter monitoring|Subjects will wear holter monitors at baseline, 6 months and 12 months.
16093113|NCT02213718|Drug|Desflurane|desflurane (7%-8% end-tidal concentration)
16093114|NCT02213718|Drug|propofol|propofol (TCI:3.5-4.0μg/min)
16093115|NCT02213718|Drug|sufentanil|TCI: 2-3 ng/ml during the duration of surgery, an expected average of 4 hours
16093116|NCT02213705|Biological|INJECTION OF ALLOGENEIC MESENCHYMAL STEM CELLS|
16093117|NCT02213679|Dietary Supplement|Guanidinoacetic acid|Dietary supplement
16093118|NCT02213679|Other|Placebo|Placebo
16093119|NCT02213666|Device|Intracardiac Imaging|Imaging of the RAA and LAA with ICE and assessment of thrombus.
16093120|NCT02213653|Drug|ARM A : IV iron + epoietin zeta|"Epoietin zeta at a dose of 450 IU / kg per week subcutaneously
~Carboxymaltose ferric (Ferinject ®) at week 1; Intravenous infusion not exceeding 1000 mg (administered once if weight> 50 kg, 500 mg twice otherwise, with an interval of one week between each administration).
~Renewable with a minimum of 4 weeks depending on the iron status (if CST <20% and absence of serum ferritin> 800) in the same manner as week 1."
16093169|NCT02213302|Drug|midazolam intravenous administration|
16093170|NCT02213289|Drug|Trastuzumab|Trastuzumab
16093171|NCT02213289|Drug|ABT-806|ABT-806
16093172|NCT02213289|Drug|Bemarituzumab|Bemarituzumab
16093121|NCT02213653|Drug|ARM B: IV iron + epoietin zeta sequence|"Epoietin zeta at a dose of 450 IU / kg per week subcutaneously started in week 7
~carboxymaltose ferric (Ferinject ®) at week 1
~Intravenous infusion not exceeding 1000 mg (administered once if weight> 50 kg, 500 mg twice otherwise, with an interval of one week between each administration).
~Renewable with a minimum of 4 weeks depending on the iron status (if CST <20% and absence of serum ferritin> 800) in the same manner as week 1."
16093122|NCT02213653|Drug|ARM C : single epoietin zeta|Epoietin zeta at a dose of 450 IU / kg per week subcutaneously begun in week 1
16093123|NCT02213640|Device|transcranial direct current stimulation (tDCS)|Anodal tDCS over the primary motor cortex. Stimulation intensity of 1mA during 20 minutes (5 consecutive sessions during one week).
16093124|NCT02213640|Device|Control: placebo stimulation|electrode of sham tDCS over the primary motor cortex during 20 minutes (5 consecutive sessions during one week).
16093125|NCT02213627|Drug|Corifollitropin alfa|
16093126|NCT02213627|Drug|Recombinant FSH|
16093127|NCT02213627|Drug|HP-hMG|
16093128|NCT02213614|Dietary Supplement|Lithium Water|Supply daily doses of Lithium water in form bottled mineral water
16093129|NCT02213614|Dietary Supplement|placebo: spring mineral water|Drink spring natural water a placebo 3 times a day
16093130|NCT02213614|Other|natural spring water|A group will drink natural spring water for 4 months
16093131|NCT02213601|Behavioral|Yoga|
16093132|NCT02213588|Dietary Supplement|AOX blend|Antioxidant supplement
16093133|NCT02213588|Dietary Supplement|Placebo|
16093134|NCT02213575|Drug|Minocycline|Subjects will receive the dose of Minocycline determined to best lower BP and will undergo baseline and week 12-24 follow-up MRI and PET scans for changes in the paraventricular nucleus.
16093135|NCT02213562|Dietary Supplement|200 mg of chrysanthemum flower oil|
16093136|NCT02213562|Dietary Supplement|300 mg of chrysanthemum flower oil|
16093137|NCT02213562|Dietary Supplement|400 mg of chrysanthemum flower oil|
16093138|NCT02213549|Dietary Supplement|Placebo|
16093139|NCT02213549|Dietary Supplement|Ume paste and ginger powder|
16093140|NCT02213536|Radiation|VMAT (Volumetric Modulated Arc Therapy)|Delivering a prescribed radiation dose to the whole brain using VMAT to reduce dose to hair follicles on scalp.
16093141|NCT02213523|Dietary Supplement|Plant concentrate A|Screening for the optimal dosage by starting with with a low dose of 300 mg for one week then switch to 600 mg for one week.
16093142|NCT02213523|Dietary Supplement|Plant concentrate B|Screening for the optimal dosage by starting with with a low dose of 300 mg for one week then switch to 600 mg for one week.
16093143|NCT02213523|Dietary Supplement|Plant concentrate C|Screening for the optimal dosage by starting with with a low dose of 300 mg for one week then switch to 600 mg for one week.
16093144|NCT02213523|Dietary Supplement|Plant concentrate D|Screening for the optimal dosage by starting with with a low dose of 300 mg for one week then switch to 600 mg for one week.
16093145|NCT02213510|Device|Zip Surgical Skin Closure Device|The Zip Surgical Skin Closure device is a single use, sterile medical device that replaces sutures, staples, and glue for closure of the skin layer for surgical incisions or laceration repair. The device will applied by the surgeon at the end of the CIED procedure and be worn until the two week post-operative wound check.
16093146|NCT02213510|Device|Standard Suture Closure|The surgeon will perform standard suture closure for the skin layer following CIED procedure.
16093147|NCT02213497|Radiation|18F-FDG (Fluorodeoxyglucose) PET|
16093148|NCT02213497|Drug|Carboplatin|
16093149|NCT02213497|Drug|Paclitaxel|
16093150|NCT02213458|Behavioral|Navigated Care|"Navigated Care emphasizes continuous and personalized care and is based on 3 modules: the Caregiver Module that includes educational interventions and connects families with community resources, the Decision-Making Module that facilitates proactive medical, financial, and safety decisions, and the Medication Module that identifies inappropriate medication usage via pharmacist review. Innovative technology in the form of a dashboard functions as a patient care management system used by Care Team Navigators (CTNs)."
16093151|NCT02213432|Biological|Different timing of influenza vaccination|The timing of Influenza vaccination for cancer patients receiving chemotherapy will be differently assigned to day 1 or day 11.
16093152|NCT02213419|Drug|Endoscopic ultrasonography-guided double ethanol lavage|"A radial echoendoscope and a 22 gauge needle were then used for cyst fluid aspiration and ethanol lavage.
~The 80 percent volume of cyst fluid was aspirated, and the pure ethanol was injected into the collapsed cyst until the original shape was restored. After 3-5 minutes, the reaspiration of the injected ethanol was then performed. The pure ethanol was reinjected into the collapsed cyst, followed by reaspiration of maximal possible volume for 3-5 minutes."
16093153|NCT02213406|Dietary Supplement|yogurt|Subjects will receive yogurt with varying fat concentrations
16093154|NCT02213393|Dietary Supplement|Protein enriched products|The intervention group receives CwC protein enriched products. After discharge the intervention group receives CwC products delivered at home for 12 weeks.
16093155|NCT02213393|Dietary Supplement|Usual menu|The control group receives the usual menu, which is energy and protein rich in this elderly patient group. After discharge the control group receives regular products, no protein enrichment, at home for 12 weeks.
16093156|NCT02213380|Procedure|method of anesthesia|"General anesthesia and regional anesthesia.
~General anesthesia(general anesthesia combined with peripheral nerve blockade, general anesthesia combined with spinal/epidural anesthesia or single general anesthesia) will be used in group GA.
~Regional anesthesia(epidural, spinal, combined spinal and epidural anesthesia or nerve block) will be used in group RA"
16093157|NCT02213367|Drug|Bilastine|20mg (8 weeks)
16093158|NCT02213367|Drug|Bilastine|40mg
16093159|NCT02213367|Drug|Bilastin|80mg
16093160|NCT02213354|Drug|MF59|Microfluoridized adjuvant 59 (MF59) is an oil-in-water emulsion. Group 1-6 receive 3.75 mcg, 7.5 mcg and 15 mcg.
16093161|NCT02213354|Biological|Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013|Monovalent inactivated split influenza virus vaccine made with HA antigen derived from the influenza A/Shanghai/2/2013 virus. Monovalent influenza A/H7N9 virus vaccine. Group 1-6 receive 3.75 mcg, 7.5 mcg and 15 mcg.
16093162|NCT02213341|Procedure|Skin prick allergen test|To test for hypersensitivity to milk, egg, or peanut
16093163|NCT02213341|Procedure|Blood draw|
16093173|NCT02213289|Drug|Ramucirumab|Ramucirumab
16093176|NCT02213276|Other|Oral Glucose Tolerance Test (OGTT)|At baseline participants are asked to drink a glucose solution consisting of 75 grams of glucose dissolved in 250 ml of water. Meanwhile and 15 minutes, 30 minutes, 1 hour, 2 hours and 3 hours later, blood is collected from an intravenous access, in order to asses primary and secondary outcomes.
16093177|NCT02213276|Other|Intravenous Glucose Tolerance Test (IVGTT)|In this intervention, the participant needs to have two intravenous accesses. In one we infuse an adjustable 20% glucose solution, and try to mimic the glucose profile found in the oral glucose tolerance test. In order to do this, blood glucose is measured every 5 minutes. At baseline and 15 minutes, 30 minutes, 1 hour, 2 hours and 3 hours later, blood is collected from another intravenous access, in order to asses primary and secondary outcomes.
16093178|NCT02213263|Biological|PF-05280586|PF-05280586 (rituximab-Pfizer) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22
16093179|NCT02213263|Biological|MabThera®|MabThera® (rituximab-EU) concentrate for solution for infusion 375mg/m2 administered via IV infusion on Days 1, 8, 15, and 22
16093180|NCT02213250|Drug|BENEFIX|Single dose of 50 IU/kg of BeneFIX by intravenous infusion within 10 minutes.
16093181|NCT02213224|Drug|Perindopril|Perindopril is a kind of angiotensin converting enzyme inhibitors (ACEIs) which has been considered as the first-line drugs for the treatment of hypertension and has been proved safe during the widespread use.
16093182|NCT02213224|Drug|Telmisartan|Telmisartan is a kind of angiotensin receptor blockers (ARBs) which has also been considered as the first-line drugs for the treatment of hypertension and has been proved safe during the widespread use.
16093183|NCT02213224|Drug|Amlodipine|Amlodipine is also a kind of widely used first-line drugs for the treatment of hypertension, and there is no evidence showing that it is effective for NAFLD.
16093184|NCT02213211|Drug|Artemether lumefantrine|
16093185|NCT02213198|Behavioral|Engagement focused care|Engagement focused care includes a group intake appointment called Access group with flexible scheduling allowing ease of rescheduling and access as soon as the same day, as well as Shared Decision Making coaching. For Shared Decision Making, a coach meets with the person prior to or following appointments with the prescriber to assist the person regarding what to ask, what to tell, to review options, and to foster choice.
16093186|NCT02213198|Behavioral|Standard Care|Standard treatment provided by a university based transitional care clinic, with individual intakes and follow-ups for medication/therapy scheduled as soon as possible from intake but at least 1 week away-no prioritization of cases
16093187|NCT02213185|Other|EMLA patches|EMLA patches 1.5 hrs before sterile water injections
16093188|NCT02213172|Dietary Supplement|Bifidobacterium longum R0175|
16093189|NCT02213172|Dietary Supplement|Lactobacillus paracasei HA-196|
16093190|NCT02213172|Other|Placebo|
16093191|NCT02213159|Drug|Dexmedetomidine|
16093192|NCT02213159|Drug|Morphine|
16093193|NCT02213146|Drug|BioChaperone human insulin|Single dose of 0.2 U/kg body weight injected subcutaneously
16093194|NCT02213146|Drug|Huminsulin® Normal|Single dose of 0.2 U/kg body weight injected subcutaneously
16093195|NCT02213146|Drug|Humalog®|Single dose of 0.2 U/kg body weight injected subcutaneously
16093196|NCT02213133|Drug|Selinexor (KPT-330)|Oral tablet or suspension at 60, 80, 100 or 120 mg per patient-specific body surface area category. Dosing will occur twice weekly in 28-days cycle.
16093197|NCT02213107|Drug|Enzalutamide and Dutasteride|Enzalutamide by mouth daily. Dutasteride by mouth daily.
16093198|NCT02213094|Drug|Nicotinamide 500 mg|Nicotinamide 500 mg taken by mouth each morning
16093199|NCT02213094|Drug|Nicotinamide 1000 mg|Nicotinamide 1000 mg taken by mouth each morning
16093200|NCT02213081|Drug|Ulipristal|Patients will take 15mg every other day, or every 4 days per week.
16093201|NCT02213068|Drug|belatacept|Please reference Arm description for belatacept + MPA and Arm description for Arm belatacept + Low-Dose Tac for details on this intervention
16093202|NCT02213068|Drug|Tacrolimus|Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + Low-Dose Tac for details on this intervention
16093203|NCT02213068|Drug|MPA|Please see Arm Descriptions for both Standard of Care Arm Tacrolimus + MPA standard treatment regimen and belatacept + MPA for details on this intervention
16093204|NCT02213055|Drug|LICEMD|Parents/guardians of infested children will provide consent for their child's participation. Infested children whose parents agree to use the investigational product will be enrolled on the experimental arm of the study using the LiceMD product as treatment. Participants will be examined for lice count and scalp irritation the day after the first application, and one and two weeks after the first application.
16093205|NCT02213055|Drug|Standard Head lice product|The most common treatments are pesticide-based, over-the-counter remedies of permethrin (1%), or pyrethrin-based products.After baseline scalp exam for lice count and preexisting signs of irritation, parents who agree to the comparison arm may purchase any other head lice treatment of their choice. All treatments are to be done at home by a parent or guardian. All participants will be examined for lice count and scalp irritation the day after the first application, and one and two weeks after the first application. Participants may also be examined by parents or the school nurse at any time if signs of irritation or re-infestation occur. If the child is still found to be infested during any examination, the school nurse will instruct the parent/guardian to retreat.
16093206|NCT02213042|Drug|Lapatinib|Lapatinib is available as 250-mg orange tablets. Subjects randomized to the Lapatinib plus Trastuzumab arm received 1000 mg per day of Lapatinib, so wre instructed to take 4 x 250 mg tablets per day. Lapatinib was to be taken either 1 hour (or more) before a meal or 1 hour (or more) after a meal
16093207|NCT02213042|Biological|Trastuzumab|Trastuzumab is a sterile, white to pale yellow, preservative-free lyophilized powder for IV administration. Trastuzumab was administered on Day 1 of the start of Lapatinib or in conjunction with the first cycle of chemotherapy, as an 8 mg/kg loading dose. Subsequently, Trastuzumab was administered q3weekly as a 6 mg/kg maintenance dose. At the discretion of the investigator, weekly Trastuzumab could be given in either of the three treatment arms (loading dose 4mg/kg followed by weekly administration of 2mg/kg).
16093287|NCT02212483|Other|First home intervention without any advice|A first home intervention of a MIEC during the 4 weeks following inclusion, with sampling, home audit but without any advice.
16093291|NCT02212457|Biological|Bexsero|Two doses administered intramuscularly into the deltoid area at Months 0 and 2 in rMenB_0_2 Group.
16093208|NCT02213042|Drug|Aromatase Inhibitors (AIs)|Subjects who were hormone receptor-positive were required to receive an aromatase inhibitor as combination treatment; however the choice of the aromatase inhibitor selected for each patient was determined by the patients' investigator. The AIs the Investigator could choose from were anastrozole, exemestane, and letrozole and dosing was per product information.
16093209|NCT02213029|Drug|Epelsiban|White to off white Oral tablets with unit dose strength of 5 mg or 25 mg for dose level of 25 mg, 150mg or >150mg
16093210|NCT02213029|Drug|Placebo|White to off white oral placebo tablets to match 5mg epelsiban
16093211|NCT02213029|Drug|Oxytocin|Oxytocin for IV infusion (at doses of 5, 10, and 20 milliunits), IV bolus (5 IU administered IV as a bolus over 15 seconds) and IM (5 IU administered IM).
16093212|NCT02213029|Drug|Ortho-Cylcen (21)® tablet|White, blue or green tablets for oral administration per product insert to synchronize the menstrual cycles with ovulation. Ortho Cyclen (21) ® is a registered trademark of Johnson & Johnson
16093213|NCT02213016|Device|Transcranial Magnetic Stimulation|
16093214|NCT02213016|Device|Sham Transcranial Magnetic Stimulation|
16093215|NCT02213003|Biological|Islet transplantation|Transplantation of at least 5000 islet equivalents/kg of body weight onto the Omentum.
16093216|NCT02212990|Other|Acetaminophen Arm|Blinded Therapy
16093217|NCT02212990|Other|Placebo Arm|Blinded Therapy
16093218|NCT02212990|Other|Ibuprofen Arm|Open Label Therapy
16093219|NCT02212977|Device|Octylcyanoacrylate|Skin incision closure with topic skin adhesive Octylcyanoacrylate
16093220|NCT02212977|Procedure|Suture|Skin incision closure with standard subcuticular technique using a running 4-0 Polysorb suture
16093221|NCT02212951|Drug|BIOD-531|
16093222|NCT02212951|Drug|Humalog Mix 75/25|
16093223|NCT02212951|Drug|Humulin R U-500|
16093224|NCT02212938|Drug|BI 14332 CL|
16093225|NCT02212938|Other|high fat breakfast|
16093226|NCT02212925|Drug|BI 14332 CL|
16093227|NCT02212925|Drug|Placebo|
16093228|NCT02212912|Behavioral|improvement intervention|"Evidence-based clinical pathway: It contained general guideline-based recommendations about acute stroke management. Standard operating procedures (SOP) of performance indicators. A quality coordinator:The role of the quality coordinator includes interacting with physicians once gaps in the incorporation of evidence-based interventions are identified, ensuring that all components of the quality improvement intervention are being used for every acute ischemic stroke (AIS) patient.Monitoring and feedback system of performance measures.
~The system could view the level of implementation of prespecified performance measures at any time (per week recommended) , compare with the previous record of own study site and level of other clusters."
16093229|NCT02212912|Behavioral|no intervention|No intervention indicated that the physicians among control hospital provide routine
16093230|NCT02212886|Drug|GA Depot 80 mg|Recruitment completed
16093231|NCT02212886|Drug|GA Depot 40 mg|Recruitment completed
16093232|NCT02212873|Other|MyBFF@school program|Students will be required to participate in all 3 components of MyBFF@school (SSG, nutrition and psychology sessions) for 16 weeks under the supervision of trained researchers, then for another 16 weeks supervised by their respective teachers-in-charge of physical education and/or co-curriculum activity. Each SSG session will be for an hour, thrice weekly while the nutrition or psychology session will be for 30-45 minutes once a week.
16093233|NCT02212860|Radiation|Stereotactic Body Radiation Then Surgery|Stereotactic image-guided neoadjuvant ablative radiation (randomized to single dose of 21 Gy or three 10 Gy doses) followed by lumpectomy for early stage breast carcinoma
16093234|NCT02212847|Other|vestibular stimulation|
16093235|NCT02212821|Drug|Erythromycin|
16093236|NCT02212821|Drug|Placebo|physiological saline
16093237|NCT02212808|Other|Antimicrobial restriction|All prescriptions for targeted antibiotics will require phone approval by the trained PharmD during this arm. Prescribers will be instructed to contact the pharmacist via pager or phone call to discuss the patient details and the rationale for the desired antimicrobial. The pharmacist will then decide if the targeted antibiotic is approved or denied. If the pharmacist denies the use of the targeted antibiotic, the pharmacist will provide recommendations for alternative antibiotics for the specific clinical scenario. The pharmacist will document this interaction in the REDCap database.
16093238|NCT02212808|Other|Post-antimicrobial prescription review|All prescriptions for targeted antibiotics will be reviewed by the study pharmacist approximately 72 hours after initially written. The pharmacist will review and document the patient's current symptoms, pertinent clinical data, and the indication for the targeted antibiotic documented in the chart. Based on this review, the pharmacist will decide if the targeted antibiotic is necessary and/or if it needs to be modified. If a change is recommended, the pharmacist will then contact the prescriber to discuss the pharmacist's recommendations. The interaction will be documented in the REDCap database.
16093239|NCT02212795|Drug|Zabofloxacin 183mg|Zabofloxacin 183mg single dose
16093240|NCT02212795|Drug|Levofloxacin 250mg|Levofloxacin 250mg single dose
16093241|NCT02212795|Drug|Zabofloxacin 367mg|Zabofloxacin 367mg single dose
16093242|NCT02212782|Drug|Linagliptin 5mg|Linagliptin 5mg once daily for 7 days
16093243|NCT02212782|Drug|DW1029M 1200mg and Linagliptin 5mg|Linagliptin 5mg 1 tablet once daily and DW1029M 300mg 2 tablets b.i.d for 7 days
16093244|NCT02212769|Drug|Losartan 50mg|Losartan 50mg once daily for 7 days
16093245|NCT02212769|Drug|DW1029M 1200mg and Losartan 50mg|Losartan 50mg 1 Tablet once daily and DW1029M 300mg 2 Tablets b.i.d. for 7days
16093246|NCT02212756|Drug|DW1029M 1200mg and Metformin 1000mg|Metformin 500mg 1 Tablet and DW1029M 300mg 2 Tablets b.i.d. for 7days
16093247|NCT02212756|Drug|Metformin 1000mg|Metformin 500mg b.i.d. for 7 days
16093248|NCT02212730|Drug|Pembrolizumab Pre-Resection|200 mg administered by IV, once every 3-week cycle for a maximum of 2 cycles
16093249|NCT02212730|Procedure|Surgical Resection|Standard of care surgical resection of RCC tumor
16093250|NCT02212730|Drug|Pembrolizumab Post-Resection|200 mg administered by IV, once every 3-week cycle for a maximum of 17 cycles
16093288|NCT02212483|Other|Final home visit|"Final home visit at the end of the study after 12 months, with sampling and home audit.
~For the intervention group, checking of the advice compliance. For the both comparative groups, delivery of advices."
16093289|NCT02212470|Device|Drug Eluting Balloon Angioplasty|Angioplasty with Drug eluting balloon after pre dilatation
16093251|NCT02212717|Procedure|EUS-guided gallbladder drainage (EGBD)|The gallbladder would be identified by a linear echoendoscope (EUS) and a suitable puncture site in the stomach or the duodenum without intervening blood vessels would be located. The gallbladder would be punctured with a 19-gauge needle and a guidewire would be passed through the needle and looped in the gallbladder. The Hot AXIOS stent would then be inserted. A naso-gallbladder drain or a 5-7Fr double pigtail stents can be inserted into gallbladder if the effluent failed to clear after irrigation. This would be performed to improve drainage and avoid obstruction of the stent.
16093252|NCT02212717|Procedure|Percutaneous cholecystostomy (PC)|Trained interventional radiologists in the respective hospitals would perform the procedure under local anesthesia. A transhepatic route would be used in all patients to decrease bile leakage. An 8.5 Fr pigtail drainage catheter would be placed between the 8th or 9th intercostal space under sonographic and fluoroscopic guidance. The pigtail catheter would be drained to a bedside bag.
16093253|NCT02212704|Other|Vestibular stimulation by use of the turntable (static roll-tilt while the head is roll-tilted relative to the trunk)|
16093254|NCT02212704|Other|3D-video-head impulse testing|Evaluation of semicircular canal function. This intervention is part of the screening to determine suitability for this study
16093255|NCT02212704|Other|Vestibular-evoked myogenic potentials (VEMPs)|Evaluation of otolith function. This intervention is part of the screening to determine suitability for this study
16093256|NCT02212678|Drug|N-acetylcysteine capsule|N-acetylcysteine capsule
16093257|NCT02212665|Behavioral|High intense interval training|
16093258|NCT02212665|Behavioral|Increased daily activity detected by the pedometer|
16093259|NCT02212665|Behavioral|Increased daily activity detected by the pedometer+HIIT|
16093260|NCT02212665|Behavioral|Increased daily activity detected by the pedometer+group intervention|
16093261|NCT02212652|Dietary Supplement|Vitamin D|10,000 IU of VitD3 daily (one gel daily)
16093262|NCT02212652|Other|Placebo|Gummy button placebo, which will appear very similar to the vitamin D supplement.
16093263|NCT02212652|Other|Standard of Care|Patients will receive the standard care provided to all patients undergoing bariatric surgery regardless of research study participation status.
16093264|NCT02212639|Drug|digoxin|All patients will receive Digoxin without interruption. Doses can be modified individually to reach a serum drug concentration of 0.6 to 1.2 ng/ml for patients <75 years and between 0.5-0.8 ng/ml in patients older than 75 years
16093265|NCT02212626|Device|Rotarex S|
16093266|NCT02212613|Drug|Brexpiprazole|Treatment (6 weeks) Up to 2 mg/day, once daily dose, tablets, orally
16093267|NCT02212600|Other|Observational|observational cohort of proximal humerus fractures
16093268|NCT02212587|Drug|TOBI|New inhalation devices such as the podhaler can administer tobramycin inhalation powder TIP/TOBI and achieve very high sputum drug levels. TOBI will be administered using the Podhaler
16093269|NCT02212574|Drug|Lomustine|Chemotherapy Cycle A Lomustine (CCNU) is given by mouth on Day 1.
16093270|NCT02212574|Drug|Vincristine|Chemotherapy Cycle A Vincristine is given directly into a vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1, 8, and 15.
16093271|NCT02212574|Drug|Cisplatin|Chemotherapy Cycle A Cisplatin is given directly into a vein over 8 hours on Day 1.
16093272|NCT02212574|Drug|Cyclophosphamide|Chemotherapy Cycle B Cyclophosphamide is given into a vein over 1 hour on Days 1 and 2.
16093273|NCT02212574|Drug|Mesna|Chemotherapy Cycle B MESNA, a drug to protect the bladder from the effects of cyclophosphamide, will be given 15 minutes before each dose of cyclophosphamide and repeated at 3 and 6 hours.
16093274|NCT02212574|Drug|Vincristine|Chemotherapy Cycle B Vincristine is given directly into a vein directly into the vein (IV) over one minute or using a minibag over several minutes by some institutions on Days 1 and 8.
16093275|NCT02212561|Drug|Selinexor|Given orally on days 1,3,8,10,22 and 24 of each cycle
16093276|NCT02212561|Drug|Fludarabine|Will be given intravenously (IV) over 30 minutes daily on days 16 through 20. Fludarabine may be given prior to day 16 if it is determined to be in the participant's best interest based on disease progression. Chemotherapy may be delayed by 1-3 days if clinically indicated.
16093277|NCT02212561|Drug|Cytarabine|Will be given IV over 4 hours daily on days 16 through 20. Cytarabine may be given prior to day 16 if it is determined to be in the participant's best interest based on disease progression. Chemotherapy may be delayed by 1-3 days if clinically indicated.
16093278|NCT02212561|Drug|methotrexate/hydrocortisone/cytarabine|Intrathecal (IT) triples will be given prior to cycle 1: IT cytarabine, IT methotrexate, and IT methotrexate/hydrocortisone/cytarabine (MHA) are acceptable. Patients without evidence of central nervous system (CNS) leukemia will receive no further IT therapy during cycle 1. Patients with CNS disease will receive weekly ITMHA until the cerebrospinal fluid becomes free of leukemia (minimum of 4 doses).
16093279|NCT02212548|Device|PEG Hydrogel (SpaceOAR)|A single injection of PEG hydrogel (SpaceOAR) through the perineum under transrectal ultrasound guidance while under general anaesthetic.
16093280|NCT02212535|Drug|Plerixafor|0.24 mg / kg / day, by subcutaneous injection, 11h before the beginning of cytapheresis
16093281|NCT02212522|Other|Collect of environmental data on T1D patients before diagnosis|Questionnaires on large environment during mother's pregnancy and patient's childhood, health book copies, addresses' geolocation, quantification of viral exposures using Sentinel Network data
16093282|NCT02212522|Genetic|Collect of blood samples for DNA extraction and genetic characterization (GWAS)|Collect of blood samples for DNA extraction and genetic characterization (GWAS) on Illumina platform (Centre National de Genotype)
16093283|NCT02212522|Other|Collect of clinical data on the disease and its evolution|Collect of clinical data on the disease and its evolution every 6 months after enrollment
16093284|NCT02212522|Other|Collect of environmental data on French controls (age-matched for T1D patients)|Questionnaires on large environment during mother's pregnancy and patient's childhood, health book copies, addresses' geolocation, quantification of viral exposures using Sentinel Network data
16093285|NCT02212522|Genetic|Collect of blood samples for DNA extraction and genetic characterization (GWAS)|Collect of blood samples for DNA extraction and genetic characterization (GWAS) on Illumina platform (Centre National de Genotype)
16093286|NCT02212483|Other|First home intervention with advice|A first home intervention of a MIEC during the 4 weeks following inclusion, with sampling, audit and advices.
16093290|NCT02212470|Device|Nitinol stenting|Nitinol stent deployment
16093292|NCT02212457|Other|Saline Placebo|One dose administered intramusculary in the deltoid muscle at Month 1 in ABCWY_ 0_2 Group and rMenB_0_2 Group, Month 2 in ABCWY_0_6 Group and ABCWY_0_11 Group and Month 6 in ABCWY_0_1 Group.
16093293|NCT02212457|Biological|Havrix|Two doses administered in the deltoid muscle at Month 2 and 12 in ABCWY_0_1 Group, Month 1 and 12 in Group ABCWY_0_6 Group and ABCWY_0_2_6 Group , Month 0 and 6 in ABCWY_0_11 Group and Month 6 and 12 in ABCWY_ 0_2 Group and rMenB_0_2 Group.
16093294|NCT02212457|Biological|MenABCWY|Two to three doses administered in the deltoid muscle at Month 0 and 1 in ABCWY_0_1 Group, Month 0 and 6 in ABCWY_0_6 Group, Month 1 and 12 in ABCWY_0_11 Group, Month 0, 2 and 6 in ABCWY_0_2_6 Group, Month 0 and 2 in ABCWY_ 0_2 Group and rMenB_0_2 Group.
16093295|NCT02212444|Device|Dynamic elastomeric fabric orthoses (DEFO)|A patient customised dynamic elastomeric fabric orthoses (DEFO)
16093296|NCT02212444|Device|Off -the-shelf triplanar orthoses|
16093297|NCT02212431|Drug|Cysteamine|Dose will be increased weekly from 450mg od to 450mg bd, to 450mg tds to 450mg qds, will remain on highest dose for 2 weeks
16093298|NCT02212418|Other|Abdominal hypopressive technique|postural technique based on self-elongating, body axis anteriorization, shoulders extension, and maintenance of an expiratory apnea as long as possible
16093299|NCT02212405|Device|repetitive Transcranial Magnetic Stimulation|Each participant will participate in all three arms to receive sham, 1hz and 10hz rTMS as well as PET imaging.
16093300|NCT02212405|Other|repetitive Transcranial Magnetic Stimulation Sham|The sham coil is built in the same helmet of the active coil. The sham coil is has a circular shape and placed perpendicular to the scalp within the same helmet. This coil produces a similar sound and scalp sensation as the real coil.
16093301|NCT02212392|Drug|Meropenem|inj. MEROPENEM IV 1 gram twice daily at 12 hours interval for 7-10 days
16093302|NCT02212379|Drug|raltegravir and etravirine|"Raltegravir (RAL, ISENTRESS®) 400 mg tablets will be administered as one 400 mg oral tablet PO twice daily (800 mg per day) after a meal.
~Etravirine (ETR, INTELENCE®) 200 mg tablets will be administered as one 200 mg oral tablet PO twice daily (400 mg per day) after a meal."
16093303|NCT02212366|Device|Active TDCS|Active Stimulation
16093304|NCT02212366|Device|Sham TDCS|Sham Stimulation
16093305|NCT02212353|Other|Observational study, not interventional|
16093306|NCT02212340|Drug|fresofol and remifentanil|Anesthesia is maintained with fresofol and remifentanil in TIVA group or with desflurane and remifentanil in Des group according to randomly allocated group.
16093307|NCT02212340|Drug|desflurane and remifentanil|Anesthesia is maintained with fresofol and remifentanil in TIVA group or with desflurane and remifentanil in Des group according to randomly allocated group.
16093308|NCT02212314|Behavioral|Response Inhibition Training|Computerized response inhibition training will be delivered via the Internet for 10 individual sessions.
16093309|NCT02212301|Device|senofilcon A|Each study contact lens will be worn as daily wear modality for a period of 2 weeks each.
16093310|NCT02212301|Device|lotrafilcon B|Each study contact lens will be worn as daily wear modality for a period of 2 weeks each.
16093311|NCT02212288|Other|Blood sample|Blood samples are for metabolic and genetic and biological investigation
16093312|NCT02212288|Other|Urine sample|Urine sample for biological investigation
16093313|NCT02212275|Drug|Dextromethophan|A single age and weight appropriate dose of over the counter Delsym Cough Syrup containing only DXM as an active ingredient.
16093314|NCT02212249|Biological|soluble Ve cadherin|dosage of soluble VE cadherine in each arms
16093315|NCT02212236|Other|Psychological preparation|Ninety-minute, group-based psychological preparation delivered prior to haematopoietic stem cell transplantation aiming at alleviating psychological distress during the procedure by enhancing perceptions of the procedure and fostering more helpful coping.
16093316|NCT02212223|Dietary Supplement|Vitamin D3|
16093317|NCT02212210|Drug|Methylprednisolone|
16093318|NCT02212210|Drug|Normal saline|
16093319|NCT02212197|Drug|leuprolide acetate FluidCrystal® injection depot|
16093320|NCT02212197|Drug|leuprolide acetate|
16093321|NCT02212184|Other|Manual Diaphragm Release Technique|The therapist performs manual contact (pisiform, ulnar edge and the last three fingers) with the underside of the costal cartilage of the 7th, 8th, 9th and 10th rib, and guiding forearms toward the shoulders of the corresponding side. During inspiration, pulls the points of contact with both hands, in the direction of the head, accompanying the elevation movement of the ribs. During exhalation, deepens contact toward the inner costal, maintaining resistance. 2 sets x 10 breaths (1 min interval). Treatment will last two weeks (6 sessions) All patients will undertake four evaluations throughout treatment: Baseline Day 1 and post Day 1; Baseline Day 6 and post Day 6.
16093322|NCT02212184|Other|Manual Diaphragm release technique (sham)|Manual Diaphragm release technique (sham) In attempt to execute the sham protocol the therapist performs manual contact (pisiform, ulnar edge and the last three fingers) with the underside of the costal cartilage of the 7th, 8th, 9th and 10th rib. The therapist will hold only light touch in the landmarks, without exerting pressure or traction. The maneuver will be performed in two sets of ten deep breaths, with an one minute interval between them.
16093323|NCT02212171|Other|TRIAP|"The primary healthcare professionals organised in healthcare mini-teams, composed of 2 doctors, 2 nurses and 1 member of the administrative staff.
~Administrative staff:
~Following a flow chart, they will refer patients with mild self-limiting illnesses as well as consultations regarding chronic disorders in adults to the nurses. They will also perform administrative tasks such as the printing of prescriptions, sick leave reports and medical notes (justifying absence), etc.
~Nursing staff:
~They will carry out activities focused on health promotion, self-management and de-medicalisation during visits from patients with mild self-limiting illnesses as well as appointments for chronic diseases in adults.
~GP:
~They will develop the new portfolio of services: health promotion, joint review of patient medical records by doctors and nurses to improve the management of certain groups of patients, and organization of minor surgery services, etc."
16093324|NCT02212158|Behavioral|motivational interviewing group|Group therapy sessions will include 8 teen sessions that cover the following topics: acceptance of diabetes, family issues, division of diabetes management, communication and facilitating motivation and skill development to improve diabetes care. Motivational interviewing and cognitive behavioral techniques will be the therapeutic modalities used in sessions. Parents will be involved in 3 therapy sessions that cover topics regarding family functioning, division of responsibility and parenting strategies.
16093325|NCT02212132|Other|behavioral assessments|Neuropsychological evaluation, psychopathological assessment and fatigue
16093326|NCT02212119|Drug|Botulinum Toxin|
16093327|NCT02212119|Drug|Saline|
16093328|NCT02212106|Biological|bioCSL Trivalent Influenza Virus Vaccine (CSL TIV)|Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
16093329|NCT02212106|Biological|Comparator Quadrivalent Influenza Virus Vaccine|Subjects will receive one or two study vaccinations depending on their influenza vaccine history. The vaccine will be administered by intramuscular injection.
16093330|NCT02212080|Drug|BAY1214784|Escalating doses of 5, 20, 60, 150, 300, 600, 1000 mg of BAY1214784; single dose administration; liquid dosage form
16093331|NCT02212080|Drug|Placebo|Dose 1, 2,3, 4, 5, 6 and 7 of respective placebos; single dose administration; liquid dosage form
16093332|NCT02212067|Drug|semaglutide|Administered subcutaneously (s.c., under the skin) once weekly for 12 weeks.
16093333|NCT02212067|Drug|placebo|Administered subcutaneously (s.c., under the skin) once weekly for 12 weeks.
16093334|NCT02212054|Behavioral|conservative|anal dilatation; colonic lavage; oral probiotic
16093335|NCT02212054|Procedure|operative|one stage pull through radical colectomy
16093336|NCT02212041|Other|disposable electronic cigarettes|"Participants will receive e-cigs free of charge during 6-week. Each week for 6 weeks, participants will receive enough e-cigs to cover 150% of their usual weekly cigarette smoking rate. We will encourage participants to use the e-cigs whenever they would usually smoke a cigarette.
~During a 4-week post-distribution period, we will assess e-cig and cigarette use and other measures when e-cigs are not being freely provided and participants must purchase them on their own. The Week 10 session at the end of this period includes assessment of total nicotine intake, nicotine dependence, subjective and reinforcing effects of e-cigs and cigarettes, attitudes toward e-cigs, motivation to quit and self-efficacy for smoking cessation. At the Week 24 follow-up session we will again collect these measures to determine if any changes observed during the intervention phases have been maintained."
16093337|NCT02212028|Drug|prasugrel|the effects of whole tablets versus crushed tablets will be compared
16093338|NCT02212015|Drug|Pazopanib + Paclitaxel|pazopanib in combination with paclitaxel in the treatment of patients with advanced or metastatic angiosarcoma.
16093339|NCT02212002|Drug|IAP|maternal IAP, consisting of intravenous ampicillin given every 4 hours until delivery (first dose 2 g, following doses 1 g each).
16093340|NCT02211989|Drug|BI 14332 CL|
16093341|NCT02211989|Drug|Placebo|
16093342|NCT02211976|Drug|Bisacodyl|
16093343|NCT02211976|Drug|Simeticone|
16093344|NCT02211963|Drug|BI 44847|
16093345|NCT02211963|Drug|Placebo|
16093346|NCT02211950|Drug|BI 44847|
16093347|NCT02211950|Drug|Acarbose|
16093348|NCT02211950|Other|Japanese diet|
16093349|NCT02211937|Drug|BI 44847 solution, low dose|
16093350|NCT02211937|Drug|BI 44847 suspension, high dose|
16093351|NCT02211937|Drug|BI 44847 tablet, low dose|
16093352|NCT02211937|Drug|BI 44847 tablet, high dose|
16093353|NCT02211937|Other|high fat breakfast|
16093354|NCT02211924|Drug|BI 44847|
16093355|NCT02211924|Drug|Placebo|
16093356|NCT02211911|Drug|Bisacodyl|
16093357|NCT02211911|Drug|Sodium picosulfate|
16093358|NCT02211898|Drug|BNS003|
16093359|NCT02211885|Drug|14C-BIRB 796 BS|14C-radiolabeled BIRB 796 BS
16093360|NCT02211872|Drug|BI 2536 BS, intravenous|
16093361|NCT02211859|Drug|BI 2536|
16093362|NCT02211846|Drug|Mirabegron|oral
16093363|NCT02211833|Drug|BI 2536|
16093364|NCT02211833|Drug|Pemetrexed|
16093365|NCT02211794|Other|data collection|
16093368|NCT02211755|Drug|Bortezomib plus Clofarabine|The proteasome inhibitor bortezomib and purine nucleoside metabolic inhibitor clofarabine demonstrated greater than additive activity in combination in preclinical xenograft models
16093369|NCT02211742|Drug|Dapagliflozin|euglycemic hyperinsulinemic clamp tests and euglycemic oral glucose tolerance clamp tests after the short-term (i.e.: 3 days, equals 10mg / 24h) intake of dapagliflozin
16093370|NCT02211729|Drug|Sulphadoxine-Pyrimethamine+ Amodiaquine+ Azithromycin|Sulphadoxine-Pyrimethamine+ Amodiaquine+ Azithromycin 4 rounds during malaria transmission season
16093371|NCT02211729|Drug|Sulphadoxine-pyrimethamine + amodiaquine + placebo azithromycin|Sulphadoxine-pyrimethamine + amodiaquine + placebo azithromycin 4 rounds during malaria transmission season
16093372|NCT02211716|Device|BeGraft Peripheral Stent Graft System|
16093373|NCT02211690|Drug|dolutegravir 50 mg (one tablet daily)|
16093374|NCT02211690|Drug|emtricitabine-tenofovir 300/200 mg (one tablet daily)|
16093375|NCT02211664|Device|Passeo-18 balloon|
16093376|NCT02211664|Device|Passeo-18 Lux drug releasing balloon|
16093377|NCT02211664|Device|Pulsar-18 stent|
16093378|NCT02211638|Drug|Candesartan Cilexetil|Candesartan Cilexetil tablet
16093379|NCT02211625|Drug|Open-label TRV734 125 mg|125 mg
16093380|NCT02211625|Drug|TRV734 blinded|blinded, multiple ascending dose
16093381|NCT02211625|Drug|Oxycodone IR 10 mg|
16093382|NCT02211625|Drug|Placebo|TRV734-matched and oxycodone placebo
16093383|NCT02211612|Dietary Supplement|PUFA-group|
16093384|NCT02211612|Dietary Supplement|SFA-group|
16093385|NCT02211599|Other|15% protein|Meal to provide 15%en from protein.
16093386|NCT02211599|Other|30% protein|Meal to provide 30%en from protein.
16093387|NCT02211599|Other|Sweetened beverage|Beverage sweetened with either sugar (sucrose) or sucralose (non-nutritive sweetener).
16093388|NCT02211573|Other|Exercise, Aerobic (Water based)|Patients of this group were submitted to an aerobic water based physical training
16093389|NCT02211560|Other|Phosphatidylserine|
16093390|NCT02211560|Other|Placebo|
16093391|NCT02211547|Device|Epic 10 Diode Laser by Biolase Inc.|
16093972|NCT02207491|Drug|Timolol maleate Ophthalmic Solution 0.5% BID|1 drop BID, AM/PM, OU
16093392|NCT02211547|Other|Placebo|Single blind lack of laser treatment (the laser will be positioned and operated as if applying the treatment, but the energy transfer will not take place).
16093393|NCT02211534|Device|Pulsed Electromagnetic Field Device (Provant)|The PEMF device delivers non-thermal, non-ionizing pulsed electromagnetic energy to the target tissue, using 27.12 megahertz pulses lasting 42 microseconds and delivered 1000 times per second. The system generates an electromagnetic field that is continuously monitored and regulated to ensure consistent dosing. The therapeutic electromagnetic field is delivered by means of an applicator pad that is placed against the treatment site. The active and sham devices will be identical in appearance and all other physical characteristics in order to maintain the masking of the treatment.
16093394|NCT02211534|Device|Sham Pulsed Electromagnetic Field Device|The Sham device will be identical in appearance, physical characteristics and operation to the Active device.
16093395|NCT02211521|Biological|PRP|3ml of PRP
16093396|NCT02211521|Drug|Hyaluronic acid|3ml hyaluronic acid
16093397|NCT02211508|Device|RINCE|The NeuroPoint device is used to deliver repeat applications of RINCE therapy
16093398|NCT02211495|Device|GEKO device|Placed on the lateral aspect of the knee, when activated it causes the leg to twitch
16093399|NCT02211495|Other|Best Medical Therapy|Seen in outpatient clinic for wound care and ongoing advice
16093400|NCT02211482|Drug|dolutegravir, lamivudine|single arm
16093401|NCT02211469|Drug|BMS-986104|
16093402|NCT02211469|Drug|Placebo|
16093403|NCT02211456|Procedure|Atrial Fibrillation/flutter (AF) or Ventricular Tachycardia (VT) ablation with multi-site pacing protocol|Pacing at several endocardial sites in isolation and individually will be performed, with response to this assessed by LV dp/dt max
16093404|NCT02211443|Biological|Recombinant full human Anti-EGFR Monoclonal Antibody|
16093405|NCT02211430|Behavioral|Cognitive-Behavioral Counseling (CBC)|Participants of CBC were educated about the effects of smoking on their personal health and their pregnancy during session 1 (45 minutes counseling), and were encouraged to explore their risk perceptions and emotions, for themselves and their unborn child. During session 2, the 15-minute counseling segment highlighted the cognitive and emotion barriers undermining the participant's motivation to quit and the self-regulatory techniques for resisting personal smoking triggers. Session 3 (45 minutes counseling) involved reviewing smoking status and smoking history over the course of the pregnancy, as well as the effects of smoking on both their health and the health of their infant. Booster session was held by phone for 15 min.
16093406|NCT02211430|Behavioral|Best Practice (BC) Control|"For ethical considerations, and consistent with practice guidelines for treating tobacco addiction (Fiore et al., 2000) which mandates that every pregnant smoker be offered smoking cessation treatment, the control group has been designed to be comparable to the current best practice guidelines for smoking cessation treatments. This condition, devised from a review of the current literature, will include one brief (5-15 minutes) prenatal individual session (session 1) consisting of smoking cessation education and advice, on-site brochure pick up (session 2), and a second brief postpartum individual session (session 3) followed by receipt of a newsletter (session 4)."
16093407|NCT02211417|Drug|DS107G|
16093408|NCT02211417|Drug|Placebo|
16093409|NCT02211391|Other|Casein Protein|The effect of casein protein consumed within 30 minutes of sleep on overnight lipolysis and next morning metabolism and appetite will be examined
16093410|NCT02211391|Other|Non-caloric placebo|The effect of a non-caloric placebo consumed within 30 minutes of sleep on overnight lipolysis and next morning metabolism and appetite will be examined
16093411|NCT02211378|Other|Observer|Trainees are in the role of observers (not actively participating in simulation scenario) during first 2 simulation sessions, then placed in the role in the 'hotseat' actively participating during the third simulation session.
16093412|NCT02211378|Other|Hotseat|Trainees in the hotseat group are placed in the 'hotseat' to actively participate and manage the simulated medical crises in the simulation scenarios.
16093413|NCT02211352|Drug|Korean Red Ginseng Capsules|Korean Red Ginseng Capsules 2mg,daily, 8 week and than crossover to placebo capsules(2g), daily 8week
16093414|NCT02211352|Drug|Placebo|Korean Red Ginseng Capsules 2mg,daily, 8 week and than crossover to placebo capsules(2g), daily 8week
16093415|NCT02211339|Behavioral|Peer facilitator training|Peer facilitation of a project-based activity without staff present
16093416|NCT02211339|Other|Usual care|Staff-led social activity
16093417|NCT02211326|Behavioral|Genotype-guided dosing algorithm for warfarin|Intervention：initial dosing of warfarin for the first 3 days of treatment will be determined by IWPC( International Warfarin Pharmacogenetics Consortium) algorithm (PG-1),a second dose adjustment will be made after 3 doses of warfarin using a dose revision algorithm (PG-2) that combined INR values,the dose will be adjusted depending on the measurements of INR values after 7 days.The overall follow-up period is 12 weeks.
16093418|NCT02211326|Behavioral|Standard initiation dose for warfarin|Intervention：initial dosing of warfarin for the first 3 days of treatment will be determined by standard initiation dose. Following this initiation dose of warfarin,the dose will be adjusted depending on the measurements of INR values after 3 days.The overall follow-up period is 12 weeks.
16093419|NCT02211313|Device|Randomization to size 6 French soft vs. size 6 French hydrophobic ureteral stent.|Subjects will be randomized to one of two study arms according to ureteral stent size and degree of firmness (size 6Fr, soft vs. size 6Fr, hydrophobic) with allocation ratio of 1:1.
16093420|NCT02211300|Device|The OptiScanner|treatment of blood glucose per standard of care
16093421|NCT02211300|Device|YSI 2300 STAT Plus™|
16093422|NCT02211287|Other|'Comfort Care at the End of Life for Persons with Dementia'|A guide for caregivers to provide information on the trajectory of the disease, clinical issues, decision-making processes, and symptom management. The guide is written in a Q&A form and can help answer frequent family questions.
16093423|NCT02211287|Other|Project Nurse - ACP Facilitator|A nurse will receive training in the 'Respecting Choices Facilitator Curriculum' - an online program consisting of a series of six critical thinking modules designed for healthcare professionals who want to enhance their ACP facilitation skills. Local training resources in Northern Ireland will supplement.
16093576|NCT02210299|Other|Exposure study|Sampling of blood, food, water, air and dust and delivery of dietary questionnaire
16093577|NCT02210286|Dietary Supplement|Magtein|
16093973|NCT02207491|Drug|AR-13324 Ophthalmic Solution 0.02%|1 drop once daily (QD), PM, OU
16093424|NCT02211274|Other|Everyday Competence Assessment and Planning for Community Transitions|The Everyday Competence Assessment and Planning for Community Transitions (ECAP-CT) toolkit will allow CLC interdisciplinary team members to 1) assess the Veteran's everyday competence for safe and independent living; 2) develop personally meaningful rehabilitation goals that facilitate successful transition out of the CLC based on everyday competence; and 3) conduct structured treatment planning to support resident goals around transitioning back into the community. By considering everyday competence and goal-setting in this context, Veterans will have optimal P-E fit upon returning to the community, ensuring a successful transition.
16093425|NCT02211261|Biological|PF-06293620|subcutaneous, single dose 0.3 mg/kg
16093426|NCT02211261|Biological|Placebo|Subcutaneous normal saline single dose
16093427|NCT02211261|Biological|PF-06293620|Subcutaneous, single dose 1.0 mg/kg
16093428|NCT02211261|Biological|Placebo|Subcutaneous normal saline single dose
16093429|NCT02211261|Biological|PF-06293620|Subcutaneous single dose 3 mg/kg
16093430|NCT02211261|Biological|Placebo|Subcutaneous normal saline single dose
16093431|NCT02211261|Biological|PF-06293620|Subcutaneous single dose 6 mg/kg
16093432|NCT02211261|Biological|Placebo|Subcutaneous normal saline single dose
16093433|NCT02211261|Biological|PF-06293620|Intravenous infusion single dose 1 mg/kg
16093434|NCT02211261|Biological|Placebo|Intravenous infusion normal saline single dose
16093435|NCT02211261|Biological|PF-06293620|Subcutaneous injection multiple dose 75 mg (Days 1, 29 and 57)
16093436|NCT02211261|Biological|Placebo|Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)
16093437|NCT02211261|Biological|PF-06293620|Subcutaneous injection multiple dose 150 mg (Days 1, 29 and 57)
16093438|NCT02211261|Biological|Placebo|Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)
16093439|NCT02211261|Biological|PF-06293620|Subcutaneous injection multiple dose 250 mg (Days 1, 29 and 57)
16093440|NCT02211261|Biological|Placebo|Subcutaneous injection normal saline multiple dose (Days 1, 29 and 57)
16093441|NCT02211261|Biological|PF-06293620|Subcutaneous injection multiple dose TBD mg (Days TBD)
16093442|NCT02211261|Biological|Placebo|Subcutaneous injection normal saline multiple dose (Days TBD)
16093443|NCT02211248|Other|Multidisciplinary assistance|Multidisciplinary group assistance was effected every two months by all professionals (physician, nurse, dietitian, physiotherapist and psychologist) and consisted in orientations and mechanisms to medication and non-pharmacological adherence (lifestyle changes).
16093444|NCT02211248|Other|Conventional treatment and follow up|Assistance was effected by physician and nurse and consisted about adapting to the drug
16093445|NCT02211222|Drug|Lenvatinib|Lenvatinib at starting doses of 24-mg, 20-mg, or 14-mg will be administered as a combination of 10-mg capsules and 4-mg capsules to be taken once a day (QD) (recommended to be taken the same time each day). Subjects will receive one of three starting doses of lenvatinib, 24-mg/day, 20-mg/day, or 14-mg/day. Dose reductions occur in succession based on the previous dose level (24, 20, 14, and 10 mg/day). Any dose reduction below 10 mg/day must be discussed with the sponsor. Once the dose has been reduced, it cannot be increased at a later date.
16093446|NCT02211209|Drug|Volanesorsen|
16093447|NCT02211209|Drug|Placebo|
16093448|NCT02211196|Behavioral|smoking cessation intervention|Receive evidence-based tobacco cessation strategies
16093449|NCT02211196|Other|survey administration|Ancillary studies
16093450|NCT02211196|Other|questionnaire administration|Ancillary studies
16093451|NCT02211183|Procedure|Best Repair of torn Rotator Cuff|
16093452|NCT02211183|Device|InSpace™ system|
16093453|NCT02211170|Drug|BIBR 796 BS, low dose|
16093454|NCT02211170|Drug|BIBR 796 BS, high dose|
16093455|NCT02211170|Drug|Placebo|
16093456|NCT02211170|Drug|Lipopolysaccharide|Lipopolysaccharide (LPS) for endotoxin challenge
16093457|NCT02211157|Drug|BIBR 796 BS|
16093458|NCT02211157|Drug|Placebo|
16093459|NCT02211157|Other|high fat breakfast|
16093460|NCT02211144|Drug|BIBR 796 BS|
16093461|NCT02211144|Drug|Placebo|
16093462|NCT02211131|Drug|Talimogene Laherparepvec|Talimogene laherparepvec will be administered by intralesional injection into the injectable cutaneous, subcutaneous, and nodal tumors initially at a dose of 10^6 plaque forming units (PFU)/mL at day 1 of week 1 followed by a dose of 10^8 PFU/mL at day 1 (±3 days) of week 4, 6, 8, 10 and 12 or until all injectable tumors have disappeared, or intolerance of study treatment or in the opinion of the investigator, immediate surgical resection or any other treatment for melanoma is warranted, whichever occurs first.
16093463|NCT02211131|Procedure|Immediate surgical resection of melanoma lesion(s)|Surgical resection of melanoma tumor lesion(s) will be performed after randomization any time during weeks 1 to 6.
16093464|NCT02211118|Drug|Intranasal dexemdetomidine (IN-DEX)|
16093465|NCT02211092|Behavioral|Physical activity intervention|A 12 week individually tailored home-based physical activity program with goal-setting, a physical activity self-monitoring technique, and weekly telephone calls provided by the intervener for coaching and support.
16093466|NCT02211092|Other|Usual care|Access to usual community resources but no active lifestyle coaching.
16093467|NCT02211079|Drug|JNJ-54861911|JNJ-54861911, 50 mg (2*25 mg tablets) orally once daily from Day 2 to Day 9.
16093468|NCT02211079|Drug|Caffeine|Single oral dose of caffeine 100 mg (2*50 mg tablets), on Day 1, 2, and 9.
16093469|NCT02211079|Drug|Midazolam|Single oral dose of midazolam 2 mg (1 mL, 2 mg/mL solution), on Day 1, 2, and 9.
16093470|NCT02211079|Drug|Tolbutamide|Single oral dose of Tolbutamide 500 mg tablet, on Day 1, 2, and 9.
16093471|NCT02211066|Drug|Clopidogrel|
16093472|NCT02211066|Drug|Ticagrelor|
16093473|NCT02211053|Drug|Levothyroxine|20 mg IV bolus + 10 mg/h infusion
16093474|NCT02211053|Drug|placebo|
16093566|NCT02210377|Other|Tianjiu|After randomization, patients in Tianjiu and placebo (non-Tianjiu) groups will receive 12 sessions of treatment over a 4-week treatment period.The format of the Tianjiu intervention will be the same as in the treatment group. Participants will be instructed to lie supine before their HD session, and then the bilateral KI1 and CV4
16093567|NCT02210377|Other|Placebo (non-Tianjiu)|The format of the placebo (clay) intervention will be the same as in the treatment group.
16093475|NCT02211040|Behavioral|My Plan|"The intervention consists of three sessions for each behaviour (ie., physical activity, fruit and vegetables intake) and is available on a website and tablets to deliver it in general practice.
~Adults can start session one on a tablet in general practice or on their own computer at home, after receiving a flyer in general practice.
~In this first session adults receive general information, monitor their behaviour and receive tailored feedback to increase awareness.
~Adults are also guided to set goals and self-efficacy is increased by modeling and problem solving methods.
~In the second and third session, adults can evaluate if they reached their goals, make coping plans and adapt their action plans."
16093476|NCT02211027|Biological|Semi-allogenic human fibroblast (MRC-5) transfected with DNA|"Each vaccination consists of up to 1 x 10e7 (not less than 7 x 10e6) DNA-transfected irradiated fibroblasts. Each vaccination will be administered intradermally using a 1 mL syringe and a 25 gauge needle.The first immunization will be administered at least 12 weeks after surgery or completion of adjuvant chemotherapy and/or radiotherapy.Three additional vaccines will be administered once a week for a total of four vaccines.
~Patients will have vaccinations administered at 4 different sites as follows:
~Site #1: Right arm Site #2: Left arm Site #3: Right thigh Site #4: Left thigh. Approximately equal numbers of transfected fibroblasts will be administered at each site."
16093477|NCT02211014|Drug|acalabrutinib|
16093478|NCT02211001|Other|Pilates Group|The exercises were applied once a week during eight weeks.
16093479|NCT02211001|Other|Segmented Dynamic Exercises Group|The exercises were applied once a week during eight weeks. once a week for eight weeks.
16093480|NCT02211001|Other|Global Postural Reeducation|The exercises were applied once a week during eight weeks.
16093481|NCT02210988|Other|acupuncture|
16093482|NCT02210988|Device|acupuncture|experimental
16093483|NCT02210988|Device|Acupuncture|
16093484|NCT02210975|Device|LES-Stimulation Device|
16093485|NCT02210962|Dietary Supplement|essential fatty acids|Yellow capsules containing eicosapentaenoic acid, docosahexaenoic acid (active)
16093486|NCT02210962|Dietary Supplement|olive oil|Yellow capsules containing olive oil (placebo)
16093487|NCT02210949|Drug|Erythropoietin subcutaneously and Iron intravenously|Administration of Erythropoietin subcutaneously and administration of iron intravenously
16093488|NCT02210936|Other|Educational Intervention|"The design is primarily a pre-post, non-equivalent comparison group test of program effectiveness. If final sample size permits, we will examine program effects for each practice environment separately. For measures that require interview data there will be no comparison group data.
~We will construct matched comparison groups of physicians for each environment for which only secondary data analysis will be conducted. The matched comparison group will be constructed using prescription data from the DoD's pharmacy data transaction system (MACH and DORN VAMC) and from SCRIPTS (community-based physicians and VA prescribers)."
16093489|NCT02210910|Device|InSpace™ system over repair|
16093490|NCT02210910|Procedure|Best Repair of torn Rotator Cuff|
16093491|NCT02210884|Dietary Supplement|Vitamin D|Weekly oral supplementation with 15,000 IU vitamin D
16093492|NCT02210871|Drug|semaglutide|All subjects will be treated with a single subcutane (s.c., under the skin) injection of 0.5 mg semaglutide.
16093493|NCT02210858|Other|Laboratory Biomarker Analysis|Correlative studies
16093494|NCT02210858|Drug|Tipifarnib|Given PO
16093495|NCT02210845|Behavioral|Supervised exercise|Supervised exercise intervention is training with professional trainers once a week. It will include aerobic exercise tailored to the individual participant.
16093496|NCT02210845|Behavioral|Financially incentivized weight Loss|Financially incentivized weight loss encourages participants to achieve a monthly goal weight reduction for a 50 dollars prize.
16093497|NCT02210845|Other|Standard Care at BCDiabetes|usual care dictated by GCP at BCDiabetes.ca
16093498|NCT02210832|Behavioral|Best practices|
16093499|NCT02210832|Behavioral|financial incentives|financial incentives provided contingent on biochemically confirmed smoking abstinence
16093500|NCT02210819|Drug|Rivaroxaban (Xarelto, BAY59-7939)|"Cohort participants are classified as rivaroxaban patient, if the patient receives initial rivaroxaban VTE treatment. Dosing according to daily clinical routine"
16093501|NCT02210819|Drug|Recommended VTE pharmacological treatments according to international guidelines|"Cohort participants are classified as Standard of care patients, if the patient receives recommended VTE pharmacological treatments according to international guidelines, e.g. unfractionated heparin, LMWH, fondaparinux, VKA, if these are also approved pharmacological treatments for VTE in the respective country. Dosing according to daily clinical routine."
16093502|NCT02210806|Drug|A006 DPI|Single dose 110 mcg, 1 inhalation
16093503|NCT02210806|Drug|A006 DPI|Single dose 220 mcg, 1 inhalation
16093504|NCT02210806|Other|Placebo DPI|Placebo, 1 inhalation
16093505|NCT02210806|Drug|Proventil® MDI|Single dose 90 mcg, 1 inhalation
16093506|NCT02210806|Drug|Proventil® MDI|Single dose 90 mcg, 2 inhalations
16093507|NCT02210793|Procedure|transepithelial PRK|
16093508|NCT02210793|Procedure|LASIK|
16093509|NCT02210780|Drug|Dupilumab|Administered via subcutaneous injection.
16093510|NCT02210780|Drug|Placebo|An inactive substance containing no medicine administered via subcutaneous injection.
16093511|NCT02210767|Other|Walnut Diet|2 oz. walnuts/day (2-3% of total calories from ALA)
16093512|NCT02210767|Other|Walnut Control Diet|2-3% ALA but no walnuts provided
16093513|NCT02210767|Other|Low ALA Diet|ALA replaced by oleic acid
16093514|NCT02210754|Other|blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin vehicle)|electronic cigarettes
16093515|NCT02210754|Other|blu™ Classic Tobacco rechargeable (2.4% nicotine, glycerin/PG vehicle)|electronic cigarettes
16093516|NCT02210754|Other|blu™ Magnificent Menthol rechargeable (2.4% nicotine, glycerin vehicle)|electronic cigarettes
16093517|NCT02210754|Other|blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin vehicle)|electronic cigarettes
16093518|NCT02210754|Other|blu™ Classic Tobacco rechargeable (1.6% nicotine, glycerin/PG vehicle)|electronic cigarettes
16093519|NCT02210754|Other|Marlboro Cigarette|cigarettes
16093568|NCT02210364|Drug|lurbinectedin (PM01183)|lurbinectedin (PM01183) 1 mg and 4 mg vials
16093569|NCT02210364|Drug|capecitabine|capecitabine 150 mg tablets
16093570|NCT02210351|Device|MRI test|
16093571|NCT02210338|Device|Karl Storz C-MAC|
16093520|NCT02210728|Drug|methylphenidate or amphetamine product|Medication is titrated over a 4-week period with stepwise increments each week. Patients and significant others complete ADHD symptom scales at baseline and before each medication visit. Patients also complete side effects scales at baseline and before each medication visit. The gradual increase will continue until there is no further improvement in symptoms and in the Clinical Global Improvement Scale or side effects are such that further increases are not indicated. Once the optimal dose is reached, the subjects remain on this dose for the remainder of the study.
16093521|NCT02210728|Behavioral|Cognitive behavioral therapy|12 sessions of group cognitive behavioral therapy. Participants also receive individual coaching 3 times a week (twice over telephone and once in person). Coaching sessions are 15 minutes each in duration and are aimed at implementation, practice, and generalization of skills acquired in therapy.
16093522|NCT02210715|Drug|Isentress.|28 subjects will change from their normal cART treatment to Raltegravir, which will be given at the standard dose of 400 mg p.o. b.i.d. for 24 months.
16093523|NCT02210715|Other|Continue usual antiretroviral therapy|28 subjects will continue with their normal cART treatment, as prescribed by their treating physician.
16093524|NCT02210702|Drug|Ethinyl Estradiol 35mcg/Norethindrone 1mg|
16093525|NCT02210702|Drug|Ethinyl Estradiol 20mcg/Norethindrone 1mg|
16093526|NCT02210689|Drug|clindamycin phosphate vaginal cream 2%|
16093527|NCT02210689|Other|placebo|vehicle used as placebo
16093528|NCT02210676|Other|PROMIS Upper Extremity|
16093529|NCT02210676|Other|Likert Pain Scale|
16093530|NCT02210676|Other|Mallet Finger Extensor Lag Measurement|
16093531|NCT02210663|Drug|veliparib (ABT-888)|Subjects will be given veliparib twice daily on Days 1-28 every 28 days orally.
16093532|NCT02210650|Procedure|Ureteral stone removal|Ureteral stone removal by the surgical procedure called Ureteroscopy
16093533|NCT02210650|Procedure|Asymptomatic kidney stones and ureteral stone removed|Asymptomatic kidney stones and Ureteral stone removal by the surgical procedure called Ureteroscopy
16093534|NCT02210624|Biological|HYNR-CS inj.|Intrathecal injection with 1ml/10kg of body weight at an interval of 26 days.
16093535|NCT02210611|Procedure|Intrauterine Insemination 36 hours|Intrauterine insemination 36 hours after ovulation induction
16093536|NCT02210611|Procedure|Intrauterine Insemination 42 hours|Intrauterine insemination 42 hours after ovulation induction
16093537|NCT02210598|Device|inpatient Foley balloon induction|The catheter will be left in place and IV oxytocin will be started per LAC+USC protocol. The foley catheter will be removed after 12 hours if not spontaneously extruded.
16093538|NCT02210598|Device|outpatient Foley balloon induction|The catheter will be deflated and removed within 10 minutes of placement. The patient will then undergo a non-stress test (NST). If the patient has a reactive NST with no late or variable decelerations or uterine tachysystole, the patient will be discharged home with clear return precautions and instructions to return to the triage area in 24 hours.
16093539|NCT02210598|Drug|Oxytocin|"When a patient randomized to the outpatient Foley Balloon induction group returns to the hospital, a sterile vaginal exam will be done and Bishop score documented. The patient will then be admitted to L&D for inpatient continuation of induction with IV oxytocin per LAC+USC protocol.
~Patients randomized to the inpatient Foley balloon induction group will have IV oxytocin initiated per LAC+USC protocol at the time of Foley balloon placement."
16093540|NCT02210585|Other|Rehabilitation|"12 weeks : 5 sessions per week (1 supervised session at home every month)
~92 weeks : spontaneous training (supervised by phone every month)"
16093541|NCT02210572|Dietary Supplement|Bimuno Galacto-oligosaccharide 1.37 g/d|Prebiotic versus low-FODMAPs diet
16093542|NCT02210572|Dietary Supplement|Low- FODMAPs diet|
16093543|NCT02210559|Drug|FG-3019|FG-3019 is administered in TREATMENT ARM A ONLY on Days 1, 8 and 15 of Treatment Cycle 1 and on Day 1 and 15 of each subsequent treatment cycle via IV infusion. The dose level is 35 mg/kg.
16093544|NCT02210559|Drug|Gemcitabine|Gemcitabine is administered on Days 1, 8 and 15 of each 28 day treatment cycle via IV infusion. The dose level is 1000 mg/m2.
16093545|NCT02210559|Drug|Nab-paclitaxel|Nab-paclitaxel is administered on Days 1, 8 and 15 of each 28 day treatment cycle via IV infusion. The dose level is 125 mg/m2.
16093546|NCT02210546|Other|Magnetic Resonance Imaging (MRI)|
16093547|NCT02210546|Other|Mammography (Mx) + ultrasonography (US)|
16093548|NCT02210520|Device|pulsatile ultrasound|1 W/cm², 2 minutes in 6 points around the back spine, three times in the week, during 10 sessions per four weeks.
16093549|NCT02210520|Device|continuous ultrasound|1 W/cm², 2 minutes in 6 points around the back spine, three times in the week, during 10 sessions per four weeks.
16093550|NCT02210520|Device|laser|1 W/cm², 2 minutes in 6 points around the back spine
16093551|NCT02210507|Other|Biofortified cassava gari|Cassava, bred to contain high amounts of vitamin A-forming carotenoids (primarily beta-carotene and its cis-derivatives).
16093552|NCT02210507|Other|White cassava gari|Non-biofortified (white) cassava and a retinyl palmitate reference dose.
16093553|NCT02210507|Other|White cassava gari + red palm oil|Non-biofortified (white) cassava gari containing red palm oil.
16093554|NCT02210494|Drug|Secretrol|
16093555|NCT02210468|Device|APIC-CF, 4 cc|
16093556|NCT02210468|Device|APIC-CF, 2 cc|
16093557|NCT02210468|Other|Placebo Comparator: Saline|Placebo Comparator: Saline
16093558|NCT02210455|Behavioral|Strongest Families FASD intervention|
16093559|NCT02210455|Other|Psychoeducation|
16093560|NCT02210442|Behavioral|educaguia intervention|Health professionals (residents) play with educational games in order to acquire knowledge and skill about management of clinical practice guidelines.
16093561|NCT02210442|Other|control group|Health professional will learn how to manage a clinical practice guidelines with standard clinical practice.
16093562|NCT02210429|Procedure|Elbow Fracture Fixation|
16093563|NCT02210416|Procedure|inguinal hernia surgery|
16093564|NCT02210403|Device|transcranial direct current stimulation (tDCS)|
16093565|NCT02210390|Behavioral|Psycho education|Psycho-education Sessions will be offered weekly basis
16093572|NCT02210338|Device|Bonfils Intubation Fibrescope|
16093573|NCT02210325|Drug|solithromycin|
16093574|NCT02210325|Drug|ceftriaxone|
16093575|NCT02210325|Drug|azithromycin|
16094317|NCT02205047|Drug|Cisplatin|
16093578|NCT02210273|Device|Solace Bladder Control (Vesair) Balloon|Subjects may undergo treatment every 12 months until study completion.
16093579|NCT02210273|Device|Solace Sham Treatment|Sham treatment that resembles treatment with the Solace Bladder Control (Vesair) Balloon
16093580|NCT02210260|Procedure|Spinal and infusion of local anaesthetic|"Spinal anaesthetic will be performed in the lateral position using a midline approach. L3/4 interspace will be identified using Tuffier's as the anatomical landmark. After confirmation of correct placement using a 25G Whitacre needle, 12.5 mg of hyperbaric Bupivacaine in a mixture with 500mcg Diamorphine will be injected intrathecally.
~PLUS
~Painbuster® catheters will be placed by the surgeon at the end of the procedure in a location determined by the surgical approach. A bolus dose of 20ml 0.25% L-Bupivacaine will be injected down the catheters prior to the connection of the elastomeric pump which will also contain 270ml 0.25% L-Bupivacaine."
16093581|NCT02210260|Procedure|Continuous infusion of local anaesthetic|A Painbuster® catheter will be placed by the surgeon at the end of the procedure in a location determined by the surgical approach. A bolus dose of 20ml 0.25% L-Bupivacaine will be injected down the catheters prior to the connection of the elastomeric pump which will also contain 270ml 0.25% L-Bupivacaine.
16093582|NCT02210260|Drug|Bupivacaine|
16093583|NCT02210260|Drug|Diamorphine|500mcg
16093584|NCT02210260|Device|A Painbuster® catheter|
16093585|NCT02210260|Device|25G Whitacre needle|
16093586|NCT02210247|Drug|EXPAREL|
16093587|NCT02210234|Dietary Supplement|50 grams of whole wheat bran cereal|This arm was randomized to eat 50 grams of whole wheat cereal during the day for 3 weeks. At baseline and at week 3 a blood sample was taken to determine if there was any alteration to the proliferation of gamma-delta T-cells.
16093588|NCT02210234|Dietary Supplement|100 grams of whole wheat bran cereal|This arm was randomized to eat 100 grams of whole wheat cereal during the day for 3 weeks. At baseline and at week 3 a blood sample was taken to determine if there was any alteration to the proliferation of gamma-delta T-cells.
16093589|NCT02210208|Device|Mepitel® Ag|"A soft silicone wound contact layer that allows exudates to pass vertically into a secondary absorbent dressing. The product provides fixation and protection of the tissues and has antimicrobial properties.
~This silicone net dressing will be used to prevent lifting and adherence of skin grafts to the dressings, as well as to prevent pain, and promote healing."
16093590|NCT02210208|Device|Mepilex® Transfer Ag|"Mepilex® Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.
~Mepilex® Transfer Ag consists of a Safetac® adhesive layer and compressed polyurethane foam containing silver sulphate and activated carbon. Safetac® is a unique adhesive technology that minimizes pain to patients and trauma to wounds and the surrounding skin. It minimizes risk for maceration by sealing the wound margins; ensuring exudate does not spread to the surrounding skin."
16093591|NCT02210195|Drug|aprepitant|125 mg daily for 8 weeks.
16093592|NCT02210195|Drug|Placebo|Placebo daily for 8 weeks.
16093593|NCT02210195|Behavioral|Manual-guided behavioral counseling|Standardized manual-guided behavioral counseling performed 1 time per week for 8 weeks in conjunction with study drug or placebo.
16093594|NCT02210182|Drug|Oral Pentamidine|Oral pentamidine given at 300 mg, 600 mg, 900 mg or 1200 mg QD x 3 consecutive days
16093595|NCT02210182|Other|Placebo|Placebo given at 300 mg, 600 mg, 900 mg or 1200 mg QD x 3 consecutive days
16093596|NCT02210169|Drug|Continuous infusion of vancomycin|Continuous infusion of vancomycin will be given as a loading dose over 1 hour then as a continuous infusion over a 24-hours period.
16093597|NCT02210156|Dietary Supplement|Omniplus Supreme|Two dietitians prepared the products (one preparer per product) by dissolving two envelopes of 20 ml of the product in 240 ml of water in a disposable cup, every day from Monday to Saturday during the intervention period (90 days of actual consumption). In order to maintain blinding, these dietitians then gave the prepared cups to two different supervisors who in turn gave the product to each participant for consumption (once-daily doses). The preparation and delivery of the product was carried out during two work shifts (morning and afternoon), depending on each participants work schedule. The supervisors recorded product administration and consumption for each participant on a control form.
16093598|NCT02210156|Other|Placebo|A product with maltodextrins, flavors and colorants without vitamins, minerals and plant extracts. Two dietitians prepared the products (one preparer per product) by dissolving two envelopes of 20 ml of the product in 240 ml of water in a disposable cup, every day from Monday to Saturday during the intervention period (90 days of actual consumption). In order to maintain blinding, these dietitians then gave the prepared cups to two different supervisors who in turn gave the product to each participant for consumption (once-daily doses). The preparation and delivery of the product was carried out during two work shifts (morning and afternoon), depending on each participants work schedule. The supervisors recorded product administration and consumption for each participant on a control form.
16093599|NCT02210117|Biological|Bevacizumab|Given IV
16093600|NCT02210117|Procedure|Biopsy|Undergo biopsy
16093601|NCT02210117|Biological|Ipilimumab|Given IV
16093602|NCT02210117|Other|Laboratory Biomarker Analysis|Correlative studies
16093603|NCT02210117|Procedure|Metastasectomy|Undergo metastasectomy
16093604|NCT02210117|Biological|Nivolumab|Given IV
16093605|NCT02210117|Procedure|Therapeutic Conventional Surgery|Undergo nephrectomy
16093606|NCT02210104|Drug|Ipilimumab|Starting Dose of Ipilimumab: 1.0 mg /kg by vein on Days 1, 22, 43, and 64.
16093607|NCT02210104|Drug|Cyclophosphamide|300 mg/m2 administered intravenously 2 days prior to T cell infusion.
16093608|NCT02210104|Biological|CD4+ T cells|Antigen-specific CD4+ T cells administered at a dose of 10^10 cells/m^2 on Day 0.
16093609|NCT02210091|Biological|Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method|Pharmacokinetic (PK) analysis of ADVATE
16093610|NCT02210091|Biological|PEGylated Recombinant Factor VIII|Pharmacokinetic (PK) analysis of BAX 855
16093611|NCT02210091|Biological|PEGylated Recombinant Factor VIII|Prophylaxis treatment
16093612|NCT02210078|Biological|Allogeneic Cytomegalovirus-Specific Cytotoxic T lymphocytes|Given IV
16093613|NCT02210065|Biological|Cytomegalovirus (CMV)-Specific Cytotoxic T Cells (CTLs)|CTL product given as single infusion within 72 hours of CMV reactivation. CTL dose infused will be at a maximum dose of 10e5 viable CD3+ T cells/kg.
16093974|NCT02207491|Other|Placebo|1 drop QD, AM, OU
16093614|NCT02210052|Device|Radiofrequency cannula|Subjects with spinal hardware that are undergoing radiofrequency ablation procedures will have an additional radiofrequency cannula placed at the site of adjacent pedicle screws for temperature measurement only.
16093615|NCT02210039|Device|SECM Probe|Imaging of the esophagus using SECM probe and system.
16093616|NCT02210026|Device|Seattle-PAP|We propose to test the hypothesis that by introduction of variation in airway pressure Seattle bubble nasal continuous positive airway pressure (Seattle-PAP) reduces work of breathing in very low birth weight infants more effectively than standard bubble nasal continuous positive airway pressure.
16093617|NCT02210000|Drug|Placebo|Camicinal matching placebo is available as tablet to be taken orally with 100mL of water in the morning
16093618|NCT02210000|Drug|Camicinal|Camicinal is available as 25 mg tablet to be taken orally with 100mL of water in the morning
16093619|NCT02209987|Drug|GS-5745 SC|GS-5745 150 mg administered by SC injection formulated as a sterile, aqueous buffered solution in a single-use pre-filled syringe
16093620|NCT02209987|Drug|GS-5745 IV|GS-5745 150 mg administered by IV infusion formulated as a sterile, aqueous buffered solution in single-use glass vials
16093621|NCT02209974|Drug|Fluticasone|Administration of inhaled corticosteroids (fluticasone, 0.5 mg) each 12 hours to 8 of the 16 COPD patients versus placebo.
16093622|NCT02209974|Drug|Inhaled Placebo|
16093623|NCT02209948|Drug|Temozolomide|
16093624|NCT02209935|Other|Early Rehabilitation Protocol|
16093625|NCT02209935|Other|Usual care|
16093626|NCT02209922|Device|Transcranial direct current stimulation (tDCS)|Participants underwent tDCS(2mA) brain stimulation (20 minutes) and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.
16093627|NCT02209922|Device|Sham|During sham stimulation, the current ramped up for 30 seconds, ramped back down for 30 seconds, and then remained off for the duration of the stimulation then and simultaneous balance training(20 minutes) for 5 consecutive days,for 1 week.
16093628|NCT02209909|Drug|aspirin continuation|Patients are randomized to continue aspirin before OPCAB surgery.
16093629|NCT02209909|Drug|aspirin discontinuation|Patients are randomized to discontinue aspirin more than 4 days before OPCAB surgery.
16093630|NCT02209896|Device|The Reprieve system|BlueWind Medical neurostimulator for the treatment of neuropathic pain
16093631|NCT02209870|Behavioral|E-checklist Group|The patient group after E-checklist system deployed
16093632|NCT02209844|Drug|BI 44847|
16093633|NCT02209844|Drug|Placebo|
16093634|NCT02209831|Device|BIBR 796 BS|single dose
16093635|NCT02209831|Drug|Pantoprazole|5 days
16093636|NCT02209818|Radiation|Laser Irradiation One dose|
16093637|NCT02209818|Radiation|Laser Irradiation Two doses|
16093638|NCT02209805|Drug|BIRB 796 BS, low dose|
16093639|NCT02209805|Drug|BIRB 796 BS, high dose|
16093640|NCT02209805|Drug|Placebo|
16093641|NCT02209792|Drug|Placebo|
16093642|NCT02209792|Drug|BIBR 796 BS, 5 mg|
16093643|NCT02209792|Drug|BIBR 796 BS, 20 mg|
16093644|NCT02209779|Drug|BIBR 796 BS|
16093645|NCT02209779|Drug|Placebo|
16093646|NCT02209766|Drug|D5884|1st cohort: Dose 1(2g) D5884(n=6) in Japanese 2nd cohort: Dose 2(4g) D5884(n=6) in Japanese 3rd cohort: Dose 2(4g) D5884(n=6) in Caucasian
16093647|NCT02209766|Drug|Placebo|"st cohort: Dose 1(2g) D5884(n=3) in Japanese
~nd cohort: Dose 2(4g) D5884(n=3) in Japanese"
16093648|NCT02209753|Drug|BIRB 796 BS, low dose|
16093649|NCT02209753|Drug|BIRB 796 BS, medium dose 1|
16093650|NCT02209753|Drug|BIRB 796 BS, medium dose 2|
16093651|NCT02209753|Drug|BIRB 796 BS, high dose|
16093652|NCT02209753|Drug|Placebo|
16093653|NCT02209740|Other|Tenofovir switch|Patients switched tenofovir to different antiretroviral regimen according to physicians decision
16093654|NCT02209727|Drug|131I-Sibrotuzumab|50 mg Sibrotuzumab conjugated with 131I
16093655|NCT02209714|Drug|BIIF 1149 BS|
16093656|NCT02209714|Drug|Placebo|
16093657|NCT02209701|Drug|Porfiromycin|
16093658|NCT02209688|Drug|ESR 1150 CL|
16093659|NCT02209688|Drug|Placebo|
16093660|NCT02209675|Other|liver biopsy|C4d assessment by immunohistchemistry in liver biopsy
16093661|NCT02209662|Device|APIC-PRP|APIC-PRP
16093662|NCT02209662|Other|Placebo, Saline plus standard of care|Placebo, Saline plus standard of care
16093663|NCT02209649|Drug|Lacidipine and Telmisartan fixed dose combination (FDC) tablet|
16093664|NCT02209649|Drug|Lacidipine|
16093665|NCT02209649|Drug|Telmisartan|
16093666|NCT02209636|Drug|Lanthanum carbonate|Non-calcium containing phosphorus binder
16093667|NCT02209636|Drug|placebo|Table identical to lanthanum carbonate but with no active ingredient
16093668|NCT02209636|Drug|Ascorbic Acid|Intravenous administration during measurement of flow mediated dilation.
16093669|NCT02209636|Drug|Nitroglycerin|Drug that is administered under the tongue that relaxes blood vessels. To be administered during measurement of flow mediated dilation.
16093670|NCT02209636|Procedure|Flow-mediated dilation measurement|Measurement of the blood flow in the brachial artery, an artery in the upper arm, using ultrasound.
16093671|NCT02209636|Procedure|Aortic pulse-wave velocity|Measurement of the stiffness of the arteries using a transcutaneous tonometer, a small device placed over the skin over the carotid, brachial, radial and femoral arteries.
16093672|NCT02209636|Procedure|Endothelial cell collection|Collection of endothelial cells from vein in arm. A flexible wire is inserted through an IV into a forearm vein to collect endothelial cells for further study. This is performed at the baseline visit and and the final study visit.
16093673|NCT02209623|Biological|TDAP|
16093674|NCT02209610|Device|Electrical and Magnetic Nerve Stimulators|Stimulation of motor nerve and central nervous system
16093675|NCT02209610|Drug|Intrathecal Fentanyl|Mu-opioid receptor agonist
16093676|NCT02209597|Drug|Bupropion XL 300|"Subjects will be studied in 4 phases for a total of approximately 28 weeks:
~Phase 1: an approximately 4-week lead-in phase during which participants remain on their existing bupropion product Phases 2 - 4: randomized cross-over phases of approximately 6 weeks on each of the four bupropion study drugs (brand and 3 generics)."
16093677|NCT02209571|Other|Venous blood markers|Routine venous blood sampling
16093678|NCT02209558|Behavioral|Visual Sternal Precautions|"Visual depiction of SPs in addition to standard of care written precautions"
16093679|NCT02209545|Drug|Misoprostol|25 patients undergoing abdominal myomectomy operation will receive two tablets of misoprostol (400 mcg) buccally one hour before the operation.
16093680|NCT02209545|Drug|Placebo|25 patients undergoing abdominal myomectomy operation will receive two tablets of Vitamin B6 (100mg) buccally one hour before the operation.
16093681|NCT02209532|Device|PINPOINT|PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes
16093682|NCT02209519|Drug|Metronidazole (male partner)|500 mg PO BID for 7 days
16093683|NCT02209519|Other|Placeob (male partner)|matching placebo capsules PO BID for 7 days
16093684|NCT02209506|Drug|MLN3126|MLN3126 tablets
16093685|NCT02209506|Drug|MLN3126 Matched Placebo|MLN3126 placebo-matching tablets
16093686|NCT02209493|Behavioral|Food supplementation: nopales|Consumption of 2 cups/day of test food: nopales
16093687|NCT02209493|Behavioral|Food supplementation: cucumber|Consumption of 2 cups/day of test food: cucumber
16093688|NCT02209480|Behavioral|Alexander Technique|
16093689|NCT02209480|Device|Heat pad application|
16093690|NCT02209480|Behavioral|guided imagery|
16093691|NCT02209467|Other|Group balance training|Group balance training 60 minutes 2 times per week plus 3-5 home exercises 2 times/week. Exercises focus om core stability in sitting, standing and lying.
16093692|NCT02209454|Drug|Enantyum® oral solution|One dose of 25 mg DKP oral solution
16093693|NCT02209454|Drug|Keral® tablet|One dose of 25 mg DKP tablet
16093694|NCT02209441|Drug|Phase I Dose-finding Study of Sorafenib Study|
16093695|NCT02209428|Drug|Temozolomide|75 mg/m2/day for 21 days repeated every 4 weeks, 6 cycles.
16093696|NCT02209415|Behavioral|standard follow-up|Outpatient clinic visits
16093697|NCT02209415|Procedure|PET/CT and EUS|PET/CT and EUS
16093698|NCT02209402|Behavioral|Exercise Training|Home-based training programme consisting of daily 4x10 minutes physical exercise on a magnetically braked bicycle at a heart rate corresponding to 80-90% of the heart rate achieved at the anaerobic threshold.
16093699|NCT02209389|Device|MRI|For any sample that is identified with a positive OctavaPink result, a negative sample from the same center, as close in time as possible, and of the same age decade, will be identified and will be recalled for an MRI and any additional testing if requested by doctor's (according to MRI's results).
16093700|NCT02209376|Biological|CART-EGFRvIII T cells|
16093701|NCT02209363|Device|auto-adjusting positive airway pressure|nightly use for 6 months
16093702|NCT02209363|Other|Nasal dilator strips|nightly use for 6 months
16093703|NCT02209350|Procedure|Aorta-femoral bypass|"Access to the femoral artery is performed through a lateral incision from the inguinal ligament. Operations technique on the abdominal aorta.
~Aorta-femoral bypass. Proximal anastomosis between the prosthesis and aorta is applied in the sort of end-to-side in the reconstruction by shunting.
~After jaws prosthesis conduction on hip distal anastomosis is formed with twisting controlling. In a case of preserved antegrade blood flow the femoral artery anastomosis applied in the sort of end-to-side. If antegrade flow is absent, anastomosis is formed in the sort of end to end."
16093704|NCT02209350|Procedure|Recanalization and stenting of aorta-iliac segment|"Standard endovascular access is performed under local anesthesia and affected arterial segment is visualized.
~Stenosis or artery occlusion is passed with hydrophilic guide. In case of occlusion transluminal or subintimal (often mixed) artery recanalization is performed. To maximize the preservation of the affected artery initial patency, occlusion recanalization is performed by ante-and retrograde accesses. Then stenosis or occlusion predilation is performed with balloon catheter (balloon catheter diameter is smaller than the affected artery diameter for 1-2 mm). After control angiography stent is installed in the aorta-iliac area throughout the lesion (lesion diameter corresponds to the stenotic arteries diameter)."
16093705|NCT02209350|Drug|Therapy: aspirin and clopidogrel|prescribed long-term aspirin (100 mg daily) and clopidogrel for 3 months (75 mg daily).
16093706|NCT02209337|Device|SRS|
16093707|NCT02209324|Drug|ASP2151|
16093708|NCT02209311|Procedure|Oral mucosa biopsy|
16093709|NCT02209311|Procedure|Sinus lift with implantation of tissue engineered construction|
16093710|NCT02209311|Device|Dental implant|
16093711|NCT02209298|Device|CoreValve Transcatheter Valve|Patients should be accepted for TAVI by a multidisciplinary team. The procedure should use the Medtronic CoreValve SystemTM and point of enrolment is the day of the procedure. The choice of prosthesis size and access route (transfemoral, subclavian or direct aortic access) is to be left to the discretion of the operating team. Equally the intraprocedural details (anaesthetic, imaging etc.) will proceed as per usual practice.
16093712|NCT02209285|Behavioral|Self-Management Program for Older Adults with Multimorbidity|Individuals in the intervention group will receive a six-month community intervention consisting of three components: (1) intensive case management and community navigation; (2) a maximum of two in-home visits by the care coordinator, two in-home visits by a Registered Nurse, and three in-home visits by the Occupational therapist or Physiotherapist, and six visits by a Personal Support Worker over 6 months in addition to usual home care services; and (3) monthly interprofessional team case conferences to develop an evidence-based, patient-centred community reintegration plan.
16093713|NCT02209272|Drug|bacteriostatic saline|
16093714|NCT02209272|Drug|buffered lidocaine|
16093715|NCT02209259|Other|PROMIS Upper Extremity Function|
16093716|NCT02209259|Other|Pain intensity|
16093717|NCT02209259|Other|PROMIS depression|
16093718|NCT02209259|Other|Positive affect negative affect scale (PANAS)|
16093719|NCT02209259|Other|standard PCS|
16093720|NCT02209259|Other|positively-adjusted version of the PCS|
16093721|NCT02209246|Other|PROMIS CAT Pain Interference|
16093722|NCT02209246|Other|PROMIS CAT Pain Behavior|
16093723|NCT02209246|Other|PROMIS CAT Physical Function|
16093724|NCT02209246|Other|MISS-21|
16093725|NCT02209233|Other|Massage Therapy|
16093726|NCT02209220|Device|Positive airway pressure for the treatment of OSA|
16093727|NCT02209207|Device|Treadmill|
16093728|NCT02209207|Other|walking training|
16093926|NCT02207829|Drug|Tiotropium matching placebo|Tiotropium matching placebo once daily in the morning via HANDIHALER inhaler
16093729|NCT02209194|Device|E-liac Stent Graft System|Implantation of the E-liac Stent Graft System in combination with a peripheral covered stent and in case of aortoiliac aneurysm in combination with a AAA Stent Graft
16093730|NCT02209181|Drug|JNJ-10450232 / Not yet marketed|Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.
16093731|NCT02209181|Drug|JNJ-10450232 / Not yet marketed|Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.
16093732|NCT02209181|Drug|JNJ-10450232 / Not yet marketed|Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.
16093733|NCT02209181|Drug|acetaminophen / Tylenol|Subjects who meet the randomization criteria at baseline within 4.5 hours after dental surgery will be assigned to one of four treatment groups stratified by pharmacokinetic blood sampling schedule and by baseline pain intensity level.
16093734|NCT02209155|Drug|R-verapamil 75 mg tablet|
16093735|NCT02209155|Drug|Placebo|
16093736|NCT02209142|Other|blood prelevement|blood sample will be done at the inclusion then at T 2 weeks, T8 weeks, T30weeks
16093737|NCT02209142|Other|psychometric data collection|
16093738|NCT02209116|Other|Qb Test|Given to all participants but the results will be open or blind depending on arm allocation
16093739|NCT02209103|Dietary Supplement|Lozenge containing citrus flavonoid|
16093740|NCT02209103|Dietary Supplement|Lozenge containing citrus flavonoid formulation|
16093741|NCT02209103|Dietary Supplement|Identical looking placebo|
16093742|NCT02209090|Procedure|maternal modified sims position|Maternal Modified Sims position during at least 40 minutes for each 60 minutes
16093743|NCT02209090|Procedure|maternal free positions|At least 40 minutes each hour during labour
16093744|NCT02209077|Device|OCT performed to collect data from the back of the eye|comparative retinal parameters with Spectralis OCT
16093745|NCT02209064|Device|Pericardial access|Access to the pericardium to enable further treatments.
16093746|NCT02209051|Other|AMNIOEXCEL|Application of AMNIOEXCEL every 1-2 weeks for a period of 6 weeks or until wound closure, whichever is sooner.
16093747|NCT02209051|Other|Standard of Care, Diabetic Foot Ulcers|Advanced wound care dressings and offloading applied daily for a period of 8 weeks or until wound closure
16093748|NCT02209038|Behavioral|Expanded AD Choice|
16093749|NCT02209038|Behavioral|Expanded Life-sustaining Therapy Choice|
16093750|NCT02209025|Dietary Supplement|Theobromine|Theobromine a compound for cocoa
16093751|NCT02209025|Dietary Supplement|Placebo drink|
16093752|NCT02209012|Drug|Aminolevulinic Acid (ALA)|Levulan PDT given in CP0108
16093753|NCT02209012|Drug|Topical Solution Vehicle|Vehicle PDT given in CP0108
16093754|NCT02209012|Device|BLU-U Blue Light Photodynamic Therapy Illuminator|PDT given in CP0108
16093755|NCT02208999|Device|Neurostimulator Precision|All patients included must have been implanted with the neurostimulator Precision
16093756|NCT02208986|Drug|Triptorelin|Triptorelin is given by s.c injection for ovulation triggering.
16093757|NCT02208973|Drug|PBF-680|5, 10, 20, 40 and 60 mg of PBF-680
16093758|NCT02208973|Drug|Placebo|placebo for the dose of 5, 10, 20 and 40 mg of PBF-680
16093759|NCT02208960|Device|Neonatal Kit|"Contents of the neonatal kit:
~Clean birth kit: sterile blade, a clean plastic square, plastic gloves, hand soap, and cord ties/clamp.
~4% Chlorhexidine (CHX) lotion (15 mL) and a bag of cotton balls.
~Sunflower oil emollient (50 mL)
~ThermoSpot
~Mylar infant sleeve
~Click to heat warmer (http://www.heatinaclick.ca/products/pocket_size.html) in a fitted cloth pouch.
~Handheld battery-operated scale with suspended cloth sling. The scale will not be included with the kit but rather one will be issued to each Community Health Worker."
16093760|NCT02208960|Behavioral|Neonatal Stimulation|"A sub-set of children in the study will receive a neonatal stimulation program either on its own or in combination with the neonatal kit described above. The stimulation program will focus on teaching three key messages to enhance the caregivers' current caregiving practices, and each message is to be integrated into daily activities (e.g. during feeding, bathing, bedtime routines). By integrating the delivery of the interventions into the caregivers' daily routine, no additional time inconvenience will be added to their schedules. The key messages include:
~Eye contact and talking to children
~Responsive feeding and caregiving
~Singing songs, including those with gentle touch"
16093761|NCT02208947|Behavioral|Consumer financial incentive|Immediate financial reward upon completing self-directed ACP (e.g., completing the web-based educational modules on PREPARE steps 1-4) and a small probability of a large reward for discussing the plans with their physician (e.g., PREPARE step 5, documented by the PHC ACP attestation form).
16093762|NCT02208947|Behavioral|PREPARE|"PREPARE for your care is 5-step on-line ACP process developed specifically for low-literacy Medi-Cal populations. PREPARE can be navigated as interactive, self-directed modules or played like a movie, at a time or a place of the subject's own choosing (e.g., home, work, public library)."
16093763|NCT02208934|Drug|PBF-999|5, 10, 20 and 40 mg of PBF-999
16093764|NCT02208934|Drug|Placebo|Placebo for all dosis of PBF-999
16093765|NCT02208908|Other|Evaluation of the oral conditionand proper care|An accurate assessment of the oral condition and proper care will be carried out on day 2 (J2) of hospitalization and repeated on the day of hospital discharge by the nurse detached service, regardless of caregivers.
16093766|NCT02208882|Drug|BMS-986120|
16093767|NCT02208882|Drug|Placebo|
16093768|NCT02208882|Drug|Midazolam|
16093769|NCT02208856|Drug|BIBR 796 BS|
16093770|NCT02208856|Drug|Placebo|
16093771|NCT02208856|Other|high fat standardized breakfast|
16093772|NCT02208843|Drug|Afatinib|Afatinib tablet once daily until progression
16093773|NCT02208830|Other|pulmonary rehabilitation|Pulmonary rehabilitation: 8 week, twice weekly exercise program with aerobic treadmill training and lower limb strength training.
16093860|NCT02208284|Drug|PF-06427878|PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
16094318|NCT02205047|Drug|5-fluorouracil or Capecitabine|
16093774|NCT02208830|Other|conventional program|The conventional program is conducted with duration of 8 week, twice weekly. The techniques used will be: expiration with the glottis open in lateral posture (Eltgol), autogenous drainage (AD) and shaker. Each technique will last for 30 minutes.
16093775|NCT02208804|Device|Holmium-166-poly (L-lactic acid) microspheres|
16093776|NCT02208791|Drug|Sirolimus|Sirolimus, 2mg once daily, will be added to the maintenance immunosuppression composed of tacrolimus, prednisone and mycophenolate. The prescription of tacrolimus will be tapered down to achieve a peripheral blood trough level between 3 e 5 ng/mL and micophenolate will be reduced to 540mg bid.
16093777|NCT02208791|Drug|No intervention|
16093778|NCT02208778|Drug|Duloxetine|54 participants will be allocated for duloxetine treatment
16093779|NCT02208778|Drug|Remifentanil|27 participants will be allocated to Remifentanil infusion
16093780|NCT02208778|Drug|Placebo (for Remifentanil)|Placebo comparator to Remifentanil treatment. 27 participants will be allocated to this arm
16093781|NCT02208778|Drug|Placebo (for Duloxetine)|Sugar pill manufactured to mimic Duloxetine 30mg. 27 participants will be allocated to this intervention
16093782|NCT02208765|Device|Stress Single Photon Emission Computed Tomography|
16093783|NCT02208752|Other|Exercises|exercise program on strengthening the rotator cuff muscles and motor control of the scapula
16093784|NCT02208739|Procedure|Nonsurgical periodontal therapy|All patients were instructed in oral hygiene methods using a soft bristled toothbrush, a compact-tuft toothbrush, interdental brushes and dental floss utilizing the modified Bass technique. Full mouth debridement, which consisted of scaling and root planing, was done in a single visit for all subjects using an ultrasonic scaler and gracey curettes. Additionally, all patients were given a 0.12% Chlorhexidine mouthrinse (Hexipro®). They were instructed to rinse three times a day using 15ml each time for a period of 14 days commencing immediately after completion of full mouth debridement. Thereafter at each recall visit, all participants were re-motivated and professional prophylaxis was performed.
16093785|NCT02208739|Procedure|Oral hygiene instructions|All patients were instructed in oral hygiene methods using a soft bristled toothbrush, a compact-tuft toothbrush, interdental brushes and dental floss utilizing the modified Bass technique.
16093786|NCT02208726|Other|Sucrose pillules|Unmedicated sucrose pillules
16093787|NCT02208726|Other|Homeopathic homaccord|Sucrose pillules medicated with Picricum acidum and Phosphoricum acidum in potencies of 6CH, 30CH and 200CH.
16093788|NCT02208713|Biological|Intramuscular injection|Intramuscular injection of stem cells in patients with FSHD.
16093789|NCT02208700|Other|Oxepa|Therapeutic nutrition with EPA, GLA< and antioxidants
16093790|NCT02208700|Other|Jevity 1.5|Complete balanced nutrition with a unique fiber blend
16093791|NCT02208687|Behavioral|Energetic|Physiotherapy and occupational therapy aimed at reconditioning and social participation.
16093792|NCT02208687|Other|Control group|Usual care
16093793|NCT02208674|Other|Protocolized, pharmacist-delivered CKD Action Plan|The CKD Action plan protocolizes the screening and treatment of primary risk factors for CKD progression and cardiovascular disease among individuals with stage G3A CKD
16093794|NCT02208635|Other|Biofortified Maize|Participant in this arm were fed zinc biofortified maize (~30 µg Zn/g).
16093795|NCT02208635|Other|Fortified Maize|Participants in this arm were fed zinc-oxide fortified maize (total level of ~60 µg Zn/g).
16093796|NCT02208635|Other|Control Maize|Participants in this arm were fed maize that was not fortified or biofortified (~15 µg Zn/g maize).
16093797|NCT02208622|Dietary Supplement|Study 1: Whey Supplement Day 1|Whey supplement was given on day 1, control diet on day 2
16093798|NCT02208622|Dietary Supplement|Study 1: Whey Supplement Day 2|Control diet was given day 1, whey supplement was given day 2
16093799|NCT02208622|Dietary Supplement|Study 2: Whey Supplement|Whey supplement was given as part of diet for both day 1 and 2 of study
16093800|NCT02208609|Other|Day 1: Maize Tortillas with 20% Amaranth|Subjects received Maize tortillas with 20% Amaranth added.
16093801|NCT02208609|Other|Day 2 Maize Tortillas without 20% Amaranth|Maize tortillas without Amaranth.
16093802|NCT02208596|Drug|pentazocine|Every patient enrolled in the study will be given 15 mg pentazocine before induction.
16093803|NCT02208596|Drug|propofol|
16093804|NCT02208596|Drug|Etomidate|
16093805|NCT02208583|Drug|Docetaxel & Prednisone|Docetaxel & Prednisone: Docetaxel 75mg/m2，d1;Prednisone 5mg，bid，d1-21
16093806|NCT02208583|Drug|DP & Targeted drugs|Docetaxel 75mg/m2，d1; Prednisone 5mg，bid，d1-21;Targeted drugs for PO. Participants with EGFR gene mutation will receive a drug called Gefitinib; Participants with BRAF gene mutations will receive a drug called Vemurafenib; Participants with AKT1 gene mutations will receive a drug called Celecoxib; Participants who have ERBB2 gene mutation will receive a drug called lapatinib; Participants with PDGFRA gene mutations will receive a drug called sunitinib; Participants with PIK3CA gene mutations will receive a drug called Everolimus
16093807|NCT02208583|Drug|cisplatin & Etoposide|cisplatin & Etoposide:cisplatin 25mg/m2，d1-3; Etoposide 100 mg/m2，d1-3
16093808|NCT02208583|Drug|EP & Targeted drugs|cisplatin 25mg/m2，d1-3; Etoposide 100 mg/m2，d1-3; Targeted drugs for po. Participants with EGFR gene mutation will receive a drug called Gefitinib; Participants with BRAF gene mutations will receive a drug called Vemurafenib; Participants with AKT1 gene mutations will receive a drug called Celecoxib; Participants who have ERBB2 gene mutation will receive a drug called lapatinib; Participants with PDGFRA gene mutations will receive a drug called sunitinib; Participants with PIK3CA gene mutations will receive a drug called Everolimus
16093809|NCT02208570|Other|PPV>14%|Patients whose preoperative pulse pressure variation during spontaneous ventilation exceed 14
16093810|NCT02208570|Drug|Volume loading|Hydroxyethyl starch solution 6ml/kg iv injection
16093811|NCT02208570|Other|PPV<14%|Patients whose preoperative pulse pressure variation during spontaneous ventilation does not exceed 14
16093812|NCT02208557|Procedure|Reinforcement with Absorbable Mesh|
16093813|NCT02208557|Radiation|Control CT|"At the end of the follow up (6 Months) a CT scan will be done. Radiologically the incisional hernia is defined as a solution of continuity of the linea alba seen on the abdominal CT scan with the patient at rest.
~The radiologist is blinded to the patient's history and the technique used for midline fascial closure."
16093861|NCT02208284|Drug|Placebo|PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
16093814|NCT02208557|Other|Clinical Follow Up|The presence of incisional hernia was evaluated by physical examination at scheduled clinical visits (3 and 6 months after surgery) Clinically, an incisional hernia is defined as the presence of a reducible bulge or protrusion at the laparotomy incision scar, palpable during the Valsalva maneuver.
16093815|NCT02208544|Procedure|Diagnostic Thyroid Surgery|Diagnostic Thyroid Surgery
16093816|NCT02208544|Device|Ultrasound of the head and neck|Confirmatory Neck Ultrasonography in FDG-PET/CT negative patient in the experimental arm
16093817|NCT02208544|Radiation|FDG-PET/CT|Head and Neck FDG-PET/CT
16093818|NCT02208531|Behavioral|Psychosocial Stimulation and Nutritional Care|Psychosocial Stimulation and Nutritional Care will be provided to malnourished children and their mothers every fortnight in the Community Clinics for one year.
16093819|NCT02208518|Procedure|endoscopy ultrasound elastography|During a endoscopy ultrasound (EUS) procedure, in patients with normal pancreas at EUS, elastography was performed using a software already included in Hitachi-Avius machine, pressing the button and obtaining colors and pressure curve given by the software
16093820|NCT02208518|Device|EUS-elastography|
16093821|NCT02208505|Drug|Dexmedetomidine + Remifentanil-low dose|single dose administration (0.5mcg/kg) 10 min before end of the surgery with maintain the infusion of remifentanil (TCI 1 ng/ml) until end of surgery
16093822|NCT02208505|Drug|Remifentanil-high dose|maintain the infusion of remifentanil until end of the surgery (TCI 2 ng/ml)
16093823|NCT02208492|Drug|Levetiracetam|Levetiracetam is a second-generation antiepileptic drug that has been approved for the treatment of epilepsy in both children and adults. This anticonvulsant works by binding to the synaptic vesicle protein 2A resulting in a possible effect on neurotransmitter release from presynaptic vesicles, while the exact mechanism of action is still unclear. In both adults and children, levetiracetam treatment in has a proven efficacy in both localization-related and generalized epilepsies. In contrast to first generation, levetiracetam reports less side effects of somnolence or lethargy, but behavioral adverse events, such as changed mood state, aggression, and irritability are noted, but only a few studies have reported such effects in a systemic fashion.
16093824|NCT02208492|Drug|Carabamazepine|Carbamazepine, a first-generation antiepileptic medication, stabilizes the inactivated state of voltage-gated sodium channels, making fewer of these channels available to subsequently open, which leaves the affected cells less excitable and less seizure prone. It is approved for both focal seizures and generalized tonic-clonic or combined seizures for adults and children.
16093825|NCT02208479|Other|Non invasive ultrasound measurement of the diaphragm thickness during breathing|
16093826|NCT02208466|Device|Active Repetitive Transcranial Magnetic Stimulation (rTMS)|Subjects will undergo active low-frequency rTMS (1Hz continuous). Each session will last 20 minutes and will be conducted at 100% of the motor threshold.
16093827|NCT02208466|Drug|Fluoxetine|Subjects will receive active fluoxetine (20mg) and take orally consecutively for 90 days.
16093828|NCT02208466|Device|Sham repetitive transcranial magnetic stimulation (rTMS)|Subjects will undergo sham low-frequency rTMS (using sham coil). This session will last 20 minutes, just as the active session would, however, no magnetic pulses will be delivered.
16093829|NCT02208466|Drug|Placebo Fluoxetine|Subject will receive placebo fluoxetine (sugar pills) and will take orally consecutively for 90 days.
16093830|NCT02208453|Device|InSpace Implantation|InSpace device Implantation
16093831|NCT02208440|Procedure|Best Repair of torn Rotator Cuff|
16093832|NCT02208440|Device|InSpace™ system|
16093833|NCT02208427|Drug|Rifapentine and Isoniazid for 3 months|weekly oral Rifapentine 15 mg/kg plus Isoniazid 15 mg/kg for 12 doses
16093834|NCT02208427|Drug|Isoniazid for 9 months|daily oral Isoniazid 5 mg/kg for 9 months under supervision (conventional IPT)
16093835|NCT02208414|Procedure|NAET|NAET with acupressure and/or chiropractic procedures with the participant holding crab and shrimp energy signature vial
16093836|NCT02208414|Procedure|NAET|NAET with acupressure and/or chiropractic procedures with the participant holding water vial
16093837|NCT02208401|Procedure|conventional cold snare polypectomy|conventional cold snare polypectomy
16093838|NCT02208401|Procedure|Cold snare polypectomy with suction|Cold snare polypectomy with suction
16093839|NCT02208388|Device|computed tomography perfusion guided treatment|
16093840|NCT02208388|Device|Fractional flow reserve guided treatment|
16093841|NCT02208375|Drug|Capivasertib|Given PO
16093842|NCT02208375|Other|Laboratory Biomarker Analysis|Correlative studies
16093843|NCT02208375|Drug|Olaparib|Given PO
16093844|NCT02208375|Other|Pharmacological Study|Correlative studies
16093845|NCT02208375|Drug|Vistusertib|Given PO
16093846|NCT02208362|Biological|IL13Ralpha2-specific Hinge-optimized 4-1BB-co-stimulatory CAR/Truncated CD19-expressing Autologous TN/MEM Cells|Given via intratumoral or intraventricular catheter
16093847|NCT02208362|Biological|IL13Ralpha2-specific Hinge-optimized 41BB-co-stimulatory CAR Truncated CD19-expressing Autologous T-Lymphocytes|Given via intratumoral, intracavitary, or intraventricular catheter
16093848|NCT02208362|Other|Laboratory Biomarker Analysis|Correlative studies
16093849|NCT02208362|Procedure|Magnetic Resonance Imaging|Correlative studies
16093850|NCT02208362|Procedure|Magnetic Resonance Spectroscopic Imaging|Correlative studies
16093851|NCT02208362|Other|Quality-of-Life Assessment|Ancillary studies
16093852|NCT02208349|Device|King Video Laryngoscope|We will outfit ½ of the ambulance crews with the King Video Laryngoscope (KVL) for 6 months while the other ½ of the ambulances will use traditional direct laryngoscopy (DL). After 6 months, the groups will switch devices. We will randomly assign those ambulances that first use the KVL. After one year (12 months) we will compare the outcomes between the two methods.
16093853|NCT02208349|Device|traditional direct laryngoscopy (DL)|
16093854|NCT02208336|Other|medical chart review|Ancillary studies
16093855|NCT02208323|Device|Bubble CPAP|Respiratory assistance
16093856|NCT02208310|Drug|Cholecalciferol 10,000 IU|Cholecalciferol 10,000 IU po daily
16093857|NCT02208310|Drug|Cholecalciferol 400 IU|Cholecalciferol 400 IU po daily
16093858|NCT02208297|Drug|Loteprednol Etabonate Gel (BID)|One drop of LE gel instilled into the study eye two times per day (BID) for 14 days
16093859|NCT02208297|Drug|Vehicle Gel (BID)|One drop of vehicle gel instilled into the study eye two times per day (BID) for 14 days
16094319|NCT02205047|Drug|Trastuzumab|
16093862|NCT02208284|Drug|PF-06427878|PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
16093863|NCT02208284|Drug|Placebo|PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
16093864|NCT02208284|Drug|PF-06427878|PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
16093865|NCT02208284|Drug|Placebo|PF-06427878 or placebo will be administered once in each period as an extemporaneously prepared suspension.
16093866|NCT02208258|Device|Consure 120 Stool Management System|Novel device designed to manage fecal incontinence in hospitalized bedridden patients with liquid to semi-formed stool.
16093867|NCT02208245|Device|Ultrasound: Axillary block|Ultrasound guided axillary block
16093868|NCT02208245|Device|Ultrasound: Infraclavicular block|Ultrasound guided infraclvicular block
16093869|NCT02208245|Drug|Ropivacaine|20 ml of ropivacaine 0,5% in both groups ( axillary block and infraclavicular block)
16093870|NCT02208232|Procedure|cataract surgery|cataract surgery with implantation of intraocular lens
16093871|NCT02208219|Behavioral|Music-supported Therapy|A Music-supported Therapy training will be provided to participants in the hospital during 4 weeks (5 sessions per week, 30 min per session). In this treatment, two different musical instruments will be used: a MIDI-piano and an electronic drum set to train fine and gross movements of the affected hand, respectively. Exercises will follow a modular therapy regime with stepwise increase of complexity in the number of tones to perform, velocity, order of playing, and fingers used for playing. Each exercise will be first played by the experimenter and will be subsequently repeated by the patient.
16093872|NCT02208219|Behavioral|home-based Music-supported Therapy|A Music-supported Therapy training at home will be provided to participants during 4 weeks (5 sessions per week, 30 min per session). Patients will play a portable roll-up MIDI-piano at home connected to the Synthesia LLC software. This software displays visual stimuli across a virtual piano on the computer screen which are served as cues to press the correct piano keys. A modular regime with stepwise increase in difficulty will be set in the program. With the aim to reinforce the training and solve problems that could appear at home, once per week patients will carry out the MST session in the hospital with the therapist. During this visit, each patient will complement his/her training with the electronic drum set and in order to train gross movements.
16093873|NCT02208219|Behavioral|Conventional treatment|"This intervention comprises intensive training of the affected upper extremity during 4 weeks (5 sessions per week, 30 min per session). The conventional therapy program corresponds to standard therapies, prescribed by attending neurologists and adapted to the needs of every individual patient. Patients will receive intensive training on fine and gross movements of the affected upper extremity. A physical and occupational therapist will provide multiple exercises from the following options:
~Passive mobilization: controlled manipulation of movements to release a joint.
~Stretch and progressive resistance training.
~Task-specific training: reaching and manipulation of different objects.
~Intense physical training: repetition of sequence of movements."
16093874|NCT02208193|Behavioral|Cognitive and psycho-behavioral effects of an artistic dimension|
16093875|NCT02208180|Behavioral|Return of genomic results on cardiovascular disease risk|"Experimental group: Participants will receive genomic cardiovascular disease risk information.
~Comparator: Participants will receive lifestyle cardiovascular disease risk information. Genomic risk information will be returned after the conclusion of the study."
16093876|NCT02208167|Biological|HXTC infusion|
16093877|NCT02208154|Drug|Chlorhexidine oral care (CHX-Oro)|Oromucosal gel consisting of chlorhexidine 1%, administered 4 times daily.
16093878|NCT02208154|Drug|Selective oropharyngeal decontamination (SOD)|SOD consists of application of a paste containing colistin, tobramycin in a 2% concentration and nystatin 1 x 10^5 units. SOD will be applied to the mouth 4 times daily until extubation.
16093879|NCT02208154|Drug|Selective Digestive Decontamination (SDD)|"SDD consists of both:
~SOD (described elsewhere)
~AND 10 ml of an enteric suspension containing 100 mg colistin, 80 mg tobramycin and nystatin 2 x 10^6 i.u, to be administered via the nasogastric tube.
~The combination is administered 4 times daily (Unlike in previous studies, systemic antibiotics are not a part of SDD)"
16093880|NCT02208128|Drug|Sunitinib, Pazopanib, Bevacizumab, Everolimus...|Clinical standard
16093881|NCT02208115|Dietary Supplement|Meal composition - Low versus high GI.|
16093882|NCT02208102|Procedure|Radio-frequency catheter ablation|
16093883|NCT02208089|Procedure|Transepithelial Photorefractive Keratectomy (TransPRK)|Aberrometry or topography guided transepithelial photorefractive keratectomy (TransPRK) using the Schwind Amaris 750s excimer laser (www.eye-tech-solutions.com), an 8mm treatment diameter, and a tissue saving algorithm targeting selected higher order aberrations only. TransPRK will be followed immediately by corneal collagen cross-linking (CXL).
16093884|NCT02208089|Procedure|Corneal Collagen Cross-Linking (CXL)|"Riboflavin soak: 10 minutes total soak time; application of 0.1% riboflavin preparation (VibeX Rapid - www.avedro.com) each 2 minutes with gentle balanced salt solution irrigation to remove excess riboflavin prior to UV light exposure.
~UV light exposure: Total treatment time 8 minutes (370nm wavelength; 30mW/cm2 irradiance; 4 minutes total UV exposure time, pulsed 1.5 seconds on 1.5 seconds off; Avedro KXL I light source)"
16093885|NCT02208076|Device|easypod™|Saizen (Somatropin) as per Summary of Product Characteristics administered by easypod™
16093886|NCT02208063|Drug|Telavancin|
16093887|NCT02208063|Drug|Vancomycin|
16093888|NCT02208063|Drug|Daptomycin|
16093889|NCT02208063|Drug|Synthetic penicillin|
16093890|NCT02208063|Drug|Cefazolin|
16093891|NCT02208050|Drug|Fampridine|
16093892|NCT02208050|Drug|Placebo|
16093893|NCT02208037|Drug|Tacrolimus (ARM with Methotrexate)|Tacrolimus will be given orally at a dose of 0.05 mg/kg or intravenously at a dose of 0.03 mg/kg starting Day -3. The dose of tacrolimus may be rounded to the nearest 0.5 mg for oral formulations. Subsequent dosing will be based on blood levels. The dose should be adjusted accordingly to maintain a suggested level of 5-15 ng/mL. If patients are on medications which alter the metabolism of tacrolimus (e.g. azoles), the initial starting dose and subsequent doses should be altered as per institutional practices. Tacrolimus taper can be initiated at a minimum of 90 days post HSCT if there is no evidence of active GVHD. The rate of tapering will be done according institutional practices but patients should be off tacrolimus by Day 180 post HSCT if there is no evidence of active GVHD.
16094320|NCT02205047|Drug|Pertuzumab|
16093894|NCT02208037|Drug|Tacrolimus (ARM with MMF and Cyclophosphamide)|Tacrolimus will be given orally at a dose of 0.05 mg/kg or intravenously at a dose of 0.03 mg/kg starting Day +5. Serum levels of tacrolimus will be measured at Day 7 and then should be checked weekly thereafter, and the dose adjusted accordingly to maintain a suggested level of 5-15 ng/mL. Tacrolimus taper can be initiated at a minimum of 90 days post HSCT if there is no evidence of active GVHD. The rate of tapering will be done according to institutional practices but patients should be off tacrolimus by Day 180 post HSCT if there is no evidence of active GVHD.
16093895|NCT02208037|Drug|Methotrexate (ARM with Maraviroc)|Methotrexate will be administered, per institutional practices, at the doses of 15 mg/m2 IV bolus on Day +1, and 10 mg/m2 IV bolus on Days +3, +6 and +11 after hematopoietic stem cell infusion. The Day +1 dose of methotrexate will be given at least 24 hours after the hematopoietic stem cell infusion and at least 30 minutes after the first dose of maraviroc. Dose reduction of MTX due to worsening creatinine clearance after initiation of conditioning regimen, high serum levels or development of oral mucositis is allowed according to institutional practices.
16093896|NCT02208037|Drug|Methotrexate (ARM with Bortezomib)|Methotrexate will be administered, per institutional practices, at the doses of 15 mg/m2 IV bolus on Day +1, and 10 mg/m2 IV bolus on Days +3, +6 and +11 after hematopoietic stem cell infusion. The Day +1 dose of methotrexate will be given at least 24 hours after the hematopoietic stem cell infusion and at least 30 minutes after the first dose of bortezomib. Dose reduction of MTX due to worsening creatinine clearance after initiation of conditioning regimen, high serum levels or development of oral mucositis is allowed according to institutional practices.
16093897|NCT02208037|Drug|Maraviroc|Maraviroc will be dosed at 300 mg orally twice a day and will start on Day -3 prior to hematopoietic stem cell infusion, and continue until Day 30 post HSCT. If the patient requires a two-day stem cell infusion, maraviroc treatment will end 30 days after the first infusion day.
16093898|NCT02208037|Drug|Bortezomib|Bortezomib will be administered at the dose of 1.3 mg/m2 based upon actual body weight (ABW) as an approximately 3-5 second IV push on Days +1, +4, and +7 after hematopoietic stem cell infusion. There must be at least 72 hours between each dose of bortezomib. Subcutaneous administration of bortezomib is not allowed on this protocol.
16093899|NCT02208037|Drug|Mycophenolate mofetil|MMF will be given at a dose of 15 mg/kg three times a day (TID) based upon ABW with the maximum total daily dose not to exceed 3 grams (1g TID, IV or PO). MMF prophylaxis will start Day 5 and discontinue after the last dose on Day 35, or may be continued if active GVHD is present.
16093900|NCT02208037|Drug|Cyclophosphamide|"Hydration prior to cyclophosphamide may be given according to institutional standards.
~Mesna will be given in divided doses IV 30 min pre- and at 3, 6, and 8 hours post-cyclophosphamide or administered per institutional standards. Mesna dose will be based on the cyclophosphamide dose being given. The total daily dose of Mesna is equal to 80% of the total daily dose of cyclophosphamide.
~Cyclophosphamide [50 mg/kg ideal body weight (IBW); if ABW < IBW, use ABW] will be given on Day 3 post-transplant (between 60 and 72 hours after the start of the HSCT) and on Day 4 post-transplant (approximately 24 hours after Day 3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours (depending on volume)."
16093901|NCT02208024|Radiation|Stereotactic Body Radiation Therapy|
16093902|NCT02207998|Drug|Homeopathic complex and physiotherapy|Homoeopathic complex (Arnica montana 6CH, Bryonia alba 6CH, Causticum 6CH, Kalmia latifolia 6CH, Rhus toxicodendron 6CH and Calcarea fluoride 6CH) will comprise of medicated lactose tablets.
16093903|NCT02207998|Drug|Placebo and physiotherapy|Unmedicated lactose tablets. Physiotherapy: lower back classic massage, lumber joint manipulation and the application of a hot pack
16093904|NCT02207985|Procedure|Allogeneic hematopoietic stem cell transplantation|
16093905|NCT02207972|Device|Use of Ultrasound|The ultrasound imaging of the lumbar spine in different scanning planes facilitates the identification of the landmarks necessary for appropriate epidural space location in pregnant patients. There are two acoustic windows that are effective for lumbar spine sonographic assessment: one seen on the transverse approach, and the other seen on the longitudinal paramedian approach. The ultrasound single-screen method using the transverse approach of the lumbar spine provides reliable information regarding the landmarks required for labor epidurals. The correct interspace and midline position are identified for correct placement of the CSE analgesia.
16093906|NCT02207972|Procedure|No ultrasound used|Palpation of anatomical landmarks is used for placement of labor analgesia
16093907|NCT02207959|Drug|Proflavine Hemisulphate salt|The stomach will be sprayed with 1-10 ml of 0.01% proflavine using a standard endoscopic spray-catheter.
16093908|NCT02207959|Procedure|White-light examination|standard white light examination
16093909|NCT02207959|Procedure|Imaging with High Resolution Microendoscope|HRME will be inserted through the biopsy channel of the endoscope, gently placed against the mucosa, and images of suspicious areas will be obtained.
16093910|NCT02207946|Drug|IncobotulinumtoxinA|Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
16093911|NCT02207946|Drug|Placebo|Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
16093912|NCT02207933|Procedure|AP shifting training|AP shifting training in addition to gait training 3 times a week for 6 weeks
16093913|NCT02207933|Procedure|Gait training|Gait training only for 3 times a week for 6 weeks.
16093914|NCT02207920|Biological|AIDSVAX B/E Vaccine|600 mcg/mL to be administered as 1 mL intramuscular (IM) injection
16093915|NCT02207920|Biological|DNA-HIV-PT123 Vaccine|4 mg/mL to be administered as 1 mL IM injection
16093916|NCT02207920|Biological|Placebo for DNA-HIV-PT123|Sodium chloride for injection USP, 0.9%; administered as 1 mL IM injection
16093917|NCT02207920|Biological|Placebo for AIDSVAX B/E|Sodium chloride for injection USP, 0.9%; administered as 1 mL IM injection
16093918|NCT02207907|Drug|Sodium bicarbonate plus sodium fluoride|Experimental dentifrice containing sodium bicarbonate plus 1150 parts per million (ppm) fluoride as sodium fluoride
16093919|NCT02207907|Drug|Sodium fluoride|Toothpaste containing 1100 ppm fluoride as sodium fluoride
16093920|NCT02207881|Drug|VDO gel|VDO gel
16093921|NCT02207881|Drug|placebo|matching placebo gel
16093922|NCT02207855|Drug|Chloroprocaine|
16093923|NCT02207829|Drug|Umeclidinium|Umeclidinium 62.5 mcg once daily in the morning via nDPI
16093924|NCT02207829|Drug|Umeclidinium matching placebo|Umeclidinium matching placebo once daily in the morning via nDPI
16093927|NCT02207816|Procedure|Blood sampling|Annual blood sampling (Year 1, Year 2 and Year 3) during the present study.
16093928|NCT02207816|Biological|Malaria Vaccine 257049 (MALARIA-055 PRI)|Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).
16093929|NCT02207816|Biological|Meningococcal C Conjugate Vaccine (MALARIA-055 PRI)|Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).
16093930|NCT02207816|Biological|Cell-culture rabies vaccine (MALARIA-055 PRI)|Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).
16093931|NCT02207816|Biological|TritanrixHepB/Hib (MALARIA-055 PRI)|Administered intramuscularly into the left deltoid, during the MALARIA-055 study (NCT00866619).
16093932|NCT02207816|Biological|Polio Sabin Oral Polio Vaccine (GSK) (MALARIA-055 PRI)|Administered orally, during the MALARIA-055 study (NCT00866619).
16093933|NCT02207803|Behavioral|Transition Assistance Program|
16093934|NCT02207790|Drug|E2609|
16093935|NCT02207790|Drug|Placebo|E2609 low-dose and placebo in healthy Japanese subjects, E2609 mid-dose and placebo in healthy Japanese subjects, E2609 high-dose and placebo in healthy Japanese subjects, E2609 mid-dose and placebo in healthy White subjects
16093936|NCT02207777|Procedure|Roux-en-Y gastric bypass surgery|A surgical procedure to help subjects lose approximately 16-18% (with a range of 16-25%) of their body weight.
16093937|NCT02207777|Behavioral|Low-calorie diet|Subjects will meet with a dietitian and/or behaviorist over approximately 6 months to lose approximately 16-18% (with a range of 16-25%) of their body weight.
16093938|NCT02207764|Behavioral|Reiki|Each study participant in the intervention group will receive one Reiki intervention by a registered nurse trained in Advanced Level Reiki through the Usui Shiki Ryoho method.
16093939|NCT02207738|Device|microneedling radiofrequency device|Microneedling radiofrequency device is composed of 49 insulated microneedle which emit radiofrequency from the needle tip. This radiofreqeuncy generates dermal heat which evokes biological effect.
16093940|NCT02207738|Device|bipolar radiofrequency|bipolar radiofrequency instrument gives out bipolar radiofrequency from the hand piece tip. This bipolar radiofrequency generates dermal heat which has a lot of bilogical effect.
16093941|NCT02207725|Biological|Andexanet|
16093942|NCT02207725|Other|Placebo|
16093943|NCT02207712|Device|Noctura 400 Eye Mask|The intervention is the wearing of the eye mask
16093944|NCT02207712|Drug|Ranibizumab|Standard ranibizumab treatment only
16093945|NCT02207699|Drug|Benzonatate 200 mg|2 benzonatate 100 mg perles and 6 placebo perles give by mouth once
16093946|NCT02207699|Drug|Benzonatate 800 mg|8 benzonatate 100 mg perles given by mouth once
16093947|NCT02207699|Drug|Moxifloxacin 400 mg|1 moxifloxacin 400 mg tablet given by mouth once
16093948|NCT02207699|Drug|Placebo|8 placebo perles given by mouth once
16093949|NCT02207673|Procedure|Tailoring of the resection based on biomarker in aEcoG during epilepsy surgery|
16093950|NCT02207660|Drug|Cisplatin,P-HDFL|The P-HDFL regimen was given as follows: In each 21-day cycle, patients received 24-hour infusions of cisplatin at 45 or 50 mg/m2 and 5-FU 2,600mg/m2 plus leucovorin 300 mg/m2 intravenous 24-hour infusion on Day 1. Normal saline hydration (≧1000 mL), dexamethasone, and antiemetics (ondansetron or granisetron) were given prophylactically before each dose of cisplatin.
16093951|NCT02207647|Other|no intervention|
16093952|NCT02207634|Biological|Evolocumab|Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.
16093953|NCT02207634|Drug|Placebo|Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.
16093954|NCT02207634|Drug|Background Statin Therapy|Participants were required to be on a stable, high- to moderate-intensity statin background therapy consisting of an effective statin dose, ie, at least atorvastatin 20 mg daily or equivalent, and where locally approved, highly effective statin therapy (defined as at least atorvastatin 40 mg daily or equivalent) was recommended.
16093955|NCT02207621|Drug|AR-13324 Ophthalmic Solution 0.02%|1 drop once daily (QD), PM, OU
16093956|NCT02207621|Drug|Timolol maleate Ophthalmic Solution 0.5% BID|1 drop BID, AM/PM, OU
16093957|NCT02207621|Other|Placebo|1 drop QD, AM, OU
16093958|NCT02207621|Drug|AR-13324 Ophthalmic Solution 0.02% BID|1 drop BID, AM/PM, OU
16093959|NCT02207608|Drug|Hyaluronic Acid|Add hyaluronic acid to BCG Treatment
16093960|NCT02207608|Drug|BCG (Immucist®)|Usual BCG treatment
16093961|NCT02207595|Drug|UCB5857|"Active Substance: UCB5857
~Pharmaceutical Form: Capsule
~Concentrations: 5 mg, 10 mg, 20 mg, 30 mg, 50 mg, 100 mg
~Route of Administration: Oral Use"
16093962|NCT02207595|Other|Placebo|"Active Substance: Placebo
~Pharmaceutical Form: Capsule
~Concentrations: 5 mg, 10 mg, 20 mg, 30 mg, 50 mg, 100 mg
~Route of Administration: Oral Use"
16093963|NCT02207582|Device|Verum Prefrontal tRNS|2mA of tRNS (DC-Stimulator, NeuroConn GmbH, Germany) with a zero offset will be applied to the left and right dorsolateral prefrontal cortex. Treatment will consist of 15 days with 20 minutes stimulation per day. Voltage will be ramped at the begin and end of a stimulation for 10 seconds.
16093964|NCT02207582|Device|Placebo Prefrontal tRNS|2mA of tRNS (DC-Stimulator, NeuroConn GmbH, Germany) with a zero offset will be applied to the left and right dorsolateral prefrontal cortex. Treatment will consist of 15 days with 20 minutes stimulation per day. Voltage will be ramped at the begin and end of a stimulation for 10 seconds. Placebo stimulation will consist of just applying the ramps at the begin and end of the stimulation.
16093965|NCT02207569|Device|CoreValve Evolut R TAVR system|
16093966|NCT02207556|Drug|Doxycycline|"Doxycycline will be continued until one of the following criteria is met:
~Patient has completed 1 year of doxycycline therapy
~Patient develops any grade 3-4 toxicity related to doxycycline use."
16093967|NCT02207543|Other|Medical telephone contact|Evaluations will be conducted by telephone 15 days after hospital discharge, 30 days and then every month until 6 months.
16093968|NCT02207530|Drug|MEDI4736|MEDI4736 monotherapy
16093969|NCT02207517|Procedure|Office-based vergence/accommodative therapy|The OBVAT program has been divided into 4 phases. Within each phase there are a number of categories such as gross convergence, vergence, and accommodation. The therapy procedures in each category have been arranged sequentially from easiest to most difficult
16093970|NCT02207504|Drug|Crizotinib|Crizotinib is an ATP-competitive small-molecule inhibitor of the ALK, c-Met/HGFR, RON, and ROS receptor tyrosine kinases.
16093975|NCT02207478|Procedure|ENB|ENB is performed using an electromagnetic navigation system (LK-DW-NK-Z; Suzhou Lungcare Medical Technology Inc., China) with an internal locatable guide (LG; Lungcare) with diameter of 1.45 mm. Bronchoscopes with a working channel diameter of 2.0 mm are used (BF-260 and BF-P260F; Olympus, Japan). The LG is inserted into the GS(K-201; Olympus) beforehand, and the GS-covered LG is introduced via the working channel of the bronchoscope and navigated to the PPL finally. The LG and GS are confirmed to reach the lesion by radiograph fluoroscopy.
16093976|NCT02207478|Procedure|GS-TBLB-X-ray|A GS is introduced in the working channel of the bronchoscope alone. The GS is confirmed to reach the lesion by radiograph fluoroscopy, pathologic specimens are obtained under fluoroscopic guidance.
16093977|NCT02207465|Radiation|Radiotherapy|
16093978|NCT02207465|Drug|Gemcitabine 1000 mg|
16093979|NCT02207465|Drug|nab-paclitaxel 125 mg|
16093980|NCT02207452|Device|He-3 MRI|Hyperpolarised helium-3 Magnetic Resonance Imaging (MRI) scan pre-bronchodilator and 1 hour post-bronchodilator (after 1 hour post-bronchodilator assessments/procedures completed).
16093981|NCT02207452|Drug|Salbutamol|Salbutamol 5mg nebulised single dose
16093982|NCT02207452|Drug|Ipratropium|Ipratropium 500mcg nebulised single dose
16093983|NCT02207452|Device|MRI|Proton Magnetic Resonance Imaging (MRI) scan pre-bronchodilator and 1 hour post-bronchodilator (after 1 hour post-bronchodilator assessments/procedures completed).
16093984|NCT02207439|Drug|Nelfinavir (Viracept®) 1250 mg|
16093985|NCT02207439|Drug|FMISO|
16093986|NCT02207426|Drug|Tobramycin|
16093987|NCT02207413|Biological|Influsplit Tetra™ vaccine produced by investigational process (IP)|Influsplit Tetra™ vaccine using a new manufacturing process administered intramuscularly (IM) in the deltoid region of non-dominant arm (Dose 1) in Adults Group and in non-dominant deltoid or left anterolateral thigh (Dose 1) and dominant deltoid or right anterolateral (Dose 2 - unprimed subjects) in 6-35m and 3-17y Groups.
16093988|NCT02207413|Biological|Influsplit Tetra™ vaccine produced by licensed process (LP)|Influsplit Tetra™ vaccine using a licensed manufacturing process administered IM in the deltoid region of non-dominant arm (Dose 1) in Adults Group and in non-dominant deltoid or left anterolateral thigh (Dose 1) and dominant deltoid or right anterolateral (Dose 2 - unprimed subjects) in 6-35m and 3-17y Groups.
16093989|NCT02207400|Drug|Sodium bicarbonate and sodium fluoride|Experimental toothpaste containing sodium bicarbonate experimental dentifrice plus 1150 parts per million (ppm) fluoride as sodium fluoride
16093990|NCT02207400|Drug|Sodium fluoride|Comparator toothpaste containing 1100 ppm fluoride as sodium fluoride
16093991|NCT02207387|Drug|Azilect|Rasagiline is Parkinson's medication that can be taken alone early in the disease or with other medication and is hypothesized to produce synergistic effects with exercise.
16093992|NCT02207387|Behavioral|Exercise|Walking and other forms of exercise have been seen clinically and in numerous research studies to be effective against Parkinson's symptoms.
16093993|NCT02207387|Other|Music|
16093994|NCT02207374|Drug|semaglutide|Subject will receive either a dose of 0.5 or 1.0 mg of semaglutide once weekly (subcutaneous (s.c.) injection).Treatment duration 56 weeks.
16093995|NCT02207374|Drug|DPP-4 inhibitor|Subjects will receive one DPP-4 inhibitor in addition to pre-trial OAD monotherapy, if any, for 56 weeks.
16093996|NCT02207361|Drug|Paclitaxel, Carboplatin|Paclitaxel: 175mg/m2, IV, d1 Carboplatin: AUC 5, IV, d1 Every 21 days to 1 course of treatment.
16093997|NCT02207361|Drug|Paclitaxel, Epirubicin|Paclitaxel: 175mg/m2, IV, d1 Epirubicin: 60-80mg/m2, IV, d1 Every 21 days to 1 course of treatment.
16093998|NCT02207348|Drug|liraglutide|Each subject will receive two single doses of 0.6 mg liraglutide (one with each of the two pen-injectors)
16093999|NCT02207335|Drug|Gemcitabine，Capecitabine|Gemcitabine: 1250 mg/m2, ivgtt, 30mins, D1,8 Capecitabine: 1250 mg/m2, PO, Q12h, D1-14
16094000|NCT02207335|Drug|Gemcitabine, Carboplatin|Gemcitabine: 1250 mg/m2, ivgtt,30mins, D1,8 Carboplatin: AUC 2, ivgtt, 60mins, D1,8
16094001|NCT02207322|Other|transplant with early palliative care|the intervention include integrating early palliative care with standard transplant care to evaluate and treat patients' symptoms during stem cell transplantation
16094002|NCT02207309|Drug|Pazopanib|
16094003|NCT02207309|Drug|Placebo (for Pazopanib)|
16094004|NCT02207296|Device|Plethysmographic variability index|
16094005|NCT02207270|Behavioral|Same day discharge|Patients randomized to SDD will be discharged home on the day of their PCI, at least 6 hours following its completion. They will receive a follow up phone call from a study coordinator the next day and at 30 days to ascertain what costs (if any) were accrued and whether any adverse outcomes occurred.
16094006|NCT02207270|Behavioral|Overnight Stay|Patients who experienced uncomplicated PCI, as well as an uncomplicated 6-hour observation period, will be randomly assigned to an overnight stay, generally considered standard or routine care. Patients randomized to overnight stay will be discharged the following morning to receive a follow up phone call at 30 days to ascertain what costs (if any) were accrued and whether any adverse outcomes occurred.
16094007|NCT02207257|Drug|PER977|Reversal of edoxaban-induced anticoagulation
16094008|NCT02207257|Drug|Placebo|Reversal of edoxaban-induced anticoagulation
16094009|NCT02207257|Drug|Edoxaban|
16094010|NCT02207244|Drug|Guselkumab 100 mg|100 mg by subcutaneous injection at Weeks 0, 4, 12, and 20. Starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 72 depending upon randomized treatment group and PASI response (Group I). 100 mg by subcutaneous injection at Weeks 16 and 20. Starting at Week 28, participants will continue to receive guselkumab 100 mg through Week 72 depending upon PASI response (Group II). Starting at Week 28, participants will receive guselkumab 100 mg through Week 72 depending upon PASI response (Group III). All participants will receive guselkumab q8w starting at Week 76 through Week 252.
16094011|NCT02207244|Drug|Placebo for guselkumab|Placebo for guselkumab at Week 16, starting at Week 28, participants will continue to receive placebo for guselkumab through Week 72 depending on randomized treatment group and PASI response (Group I), at weeks 0, 4, 12 and starting at week 28 thereafter up to week 72 depending upon PASI response (Group II), at weeks 0, 4, 12, 16, and 20, starting at week 28 through week 72 depending upon PASI response (Group III).
16094012|NCT02207244|Drug|Adalimumab|80 mg by subcutaneous injection at Week 0, then 40 mg at Week 1 and every 2 weeks (q2w) thereafter through Week 23.
16094061|NCT02206802|Drug|5% minoxidil topical foam|5% minoxidil topical foam
16094013|NCT02207244|Drug|Placebo for adalimumab|Placebo for adalimumab [two 0.8 milliliter (mL) injections] at week 0 followed by one 0.8 mL injection at weeks 1, 3, 5, and every 2 week (q2w) through Week 23 (Group I and II).
16094014|NCT02207231|Drug|Guselkumab 100 mg|100 mg by subcutaneous injection at Weeks 0, 4 and q8w thereafter through Week 252 (Group 1). 100 mg by subcutaneous injection at Weeks 16, 20 and q8w thereafter through Week 252 (Group II). 100 mg by subcutaneous injection at Week 52 and q8w thereafter through Week 252 (Group III).
16094015|NCT02207231|Drug|Placebo for guselkumab|Subcutaneous injections to maintain the blind.
16094016|NCT02207231|Drug|Adalimumab|80 mg by subcutaneous injection at Week 0, then 40 mg at Week 1 and every 2 weeks (q2w) thereafter through Week 47.
16094017|NCT02207231|Drug|Placebo for adalimumab|Subcutaneous injections to maintain the blind.
16094018|NCT02207218|Drug|turoctocog alfa|No treatment given. Patients will be treated with commercially available NovoEight®. Patients will be treated according to local clinical practice at the direction of the physician.
16094019|NCT02207205|Drug|Blood drawn from indwelling catheters versus direct venipuncture|Evaluation of the source of blood samples on whole blood clotting time
16094020|NCT02207192|Other|Postural change in lung volumes: sitting to Supine|"Pulmonary function and arterial blood gases were assessed both prior to and after weight loss as part of pre-operative and 12-month follow-up evaluations.
~Pulmonary function tests were performed both in the sitting and then in the supine position."
16094021|NCT02207179|Device|LumaScan Image Guided Surgery|
16094022|NCT02207140|Dietary Supplement|HOWARU Restore|
16094023|NCT02207127|Procedure|MRI, DISE, and Surgery|
16094024|NCT02207114|Other|Biomarker Algorithm Intervention|The intervention will consist of using the biomarker identified as useful in Phase I to compile an algorithm along containing the patient's biomarker assay results and providing this as additional information for a clinical team consider using to assist in deciding to continue antibiotics. Biomarker algorithms may be different for adult versus pediatric patients, and across different types of ICUs.
16094025|NCT02207101|Dietary Supplement|E-OJ-01 (OXYJUN)|
16094026|NCT02207101|Dietary Supplement|Placebo|
16094027|NCT02207088|Drug|ombitasvir/paritaprevir/ritonavir|tablet
16094028|NCT02207088|Drug|dasabuvir|tablet
16094029|NCT02207088|Drug|Ribavirin|tablet
16094030|NCT02207075|Drug|[C11]PK-1195 PET scan|PET scan with tracer [C11]PK-1195
16094031|NCT02207062|Drug|Ibrutinib|Given PO
16094032|NCT02207062|Other|Laboratory Biomarker Analysis|Correlative studies
16094033|NCT02207049|Behavioral|Snacking|Snacks will be provided to preschoolers, either as part of total caloric needs or above total caloric needs
16094034|NCT02207049|Behavioral|No Snacking|Caloric needs will be provided to preschoolers within three meals
16094035|NCT02207036|Behavioral|Facebook intervention|90 days of Facebook messaging, weekly Ask the Doctor sessions
16094036|NCT02207036|Behavioral|Smokefree.gov|referral to the NCI Smokefree.gov website
16094037|NCT02207023|Behavioral|Healthy Lifestyle Training Program|Study participants in the Healthy Lifestyle Training Program will each receive 7 lifestyle coaching telephone-sessions (30-60 minutes) with a trained lifestyle coach over a 6 month period. The lifestyle coaches will work on a 1:1 basis with each participant to encourage healthy lifestyles.
16094038|NCT02207010|Biological|AZD1775|All patients receive a single dose of the oral study drug prior to surgery for resection of GBM.
16094039|NCT02206984|Drug|Tamoxifen|
16094040|NCT02206984|Drug|Anastrozole|
16094041|NCT02206984|Drug|Fulvestrant|
16094042|NCT02206971|Other|urine analyses feedback|biomarker feedback report regarding the urine sample analyzed for the tobacco chemicals, cotinine, nicotine and NNAL
16094043|NCT02206958|Behavioral|Defeating Urinary Incontinence with Exercise Training|"12 week multi-component program. Continence program administered by a nurse practitioner during 4 home visits. Participants do pelvic floor muscle exercises 5 days/week using a 13-minute instructional audio CD. Based on participant symptoms and preferences the following strategies are taught: bladder training, urge and suppression techniques, caffeine reduction, eliminating bladder irritants, medication adjustment, adequate fluid intake, constipation management, and reducing nocturia.
~2. Physical activity program including moderate intensity walking (30 minutes, 5 days weekly) and twice weekly group strength training sessions using Therabands led by a trained exercise instructor."
16094044|NCT02206945|Behavioral|neurofeedback|Subject provided with feedback of activity in target brain area in the form of a line graph. Cued to try to make the line go up at certain times and down at other times.
16094045|NCT02206945|Behavioral|control feedback|Subject provided with a control/placebo type of feedback in the form of a line graph. Cued to try to make the line go up at certain times and down at other times.
16094046|NCT02206932|Drug|Sofosbuvir + Simeprevir|
16094047|NCT02206906|Behavioral|Incentive intervention model|All participants will receive a real-time electronic medication monitor to monitor daily pill-taking behavior. Participants with qualifying levels of adherence will receive a weekly incentive during the intervention period. At all clinic visits participants will participate in a lottery incentive to reinforce clinic attendance and negative STI screening tests.
16094048|NCT02206893|Behavioral|Self-monitoring via Smartphone|
16094049|NCT02206893|Behavioral|Peer support via Smartphone|
16094050|NCT02206893|Behavioral|Professional support via Smartphone|
16094051|NCT02206893|Behavioral|Self-monitoring via Web (Static)|
16094052|NCT02206867|Biological|LBAL|Anti-inflammatory agents
16094053|NCT02206867|Biological|Humira|Anti-inflammatory agents
16094054|NCT02206854|Drug|R-flurbiprofen|200 mg gelatine capsule once orally
16094055|NCT02206841|Procedure|Liver biopsy|Percutaneously liver biopsy will be performed for evaluate steatosis and fibrosis.
16094056|NCT02206841|Device|ARFI|Acoustic radiation force impulse (ARFI) imaging will be performed for evaluate fibrosis of liver.
16094057|NCT02206841|Device|SWE|Supersonic shear wave elastography (SWE) will be performed for evaluate fibrosis of liver.
16094058|NCT02206841|Device|Transient elastography|Transient elastography will be performed for evaluate fibrosis of liver.
16094059|NCT02206815|Drug|Ticagrelor+Warfarin|Ticagrelor 90mg/bid + Warfarin (maintain INR 2.0-2.5)
16094060|NCT02206815|Drug|Clopidogrel+Aspirin+Warfarin|Clopidogrel 75mg/day + Aspirin 100mg/day + Warfarin(maintain INR 2.0-2.5)
16094062|NCT02206789|Drug|Prednisolone acetate1%,|efficacy of prednisolone acetate1%alone versus prednisolone acetate 1%and cyclosporine 2% in preventing graft rejection
16094063|NCT02206789|Drug|Prednisolone acetate1%, cyclosporine 2%|penetrating keratoplasty--efficacy of prednisolone acetate1%alone versus prednisolone acetate 1%and cyclosporine 2% in preventing graft rejection
16094064|NCT02206776|Drug|Intranasal Ketamine|A single dose of intranasal ketamine up to 50 mg
16094065|NCT02206776|Drug|Intranasal Midazolam|A single dose of intranasal Midazolam up to 4 mg
16094066|NCT02206763|Drug|Momelotinib (MMB)|Tablet(s) administered orally once or twice daily
16094067|NCT02206763|Drug|Erlotinib|Tablet(s) administered orally once daily.
16094068|NCT02206750|Other|Clean Air|Each subject will be exposed to clean air for 2 hours. Subjects will exercise on a bike or treadmill. Each exercise session will consist of a 15 minute exercise interval at a level of up to 25 L/min/m2BSA followed by a 15 minute rest period.
16094069|NCT02206750|Other|Ozone|Each subject will be exposed up to 0.3ppm ozone for 2 hours. Subjects will exercise on a bike or treadmill. Each exercise session will consist of a 15 minute exercise interval at a level of up to 25 L/min/m2BSA followed by a 15 minute rest period.
16094070|NCT02206737|Device|No nicotine e-cigarette|
16094071|NCT02206737|Device|Low dose nicotine e-cigarette|
16094072|NCT02206737|Device|High dose nicotine e-cigarette|
16094073|NCT02206724|Radiation|STEREOTACTIC BODY RADIOTHERAPY to the prostate gland|
16094074|NCT02206711|Drug|BMS-955176|Single dose of drug on Day 1
16094075|NCT02206685|Drug|Methadone|The treatment group will receive 0.2 mg/kg methadone diluted to a 20 ml infusion over 10 minutes
16094076|NCT02206685|Drug|Normal Saline|the control group will receive a 20 ml normal saline placebo infusion over 10 minutes
16094077|NCT02206672|Other|Micro reinjection of autologus adipose tissue|
16094078|NCT02206659|Drug|Telmisartan|
16094079|NCT02206659|Drug|Placebo|
16094080|NCT02206646|Drug|Metalyse|
16094081|NCT02206633|Device|Hydration Monitor|Measurement of the ultrasound velocity with the Hydration Monitor for specific anatomic locations. Triplicate measurements will be made for each time-point. All subjects will also be measured for bioelectrical impedance analysis (BIA) and estimation of total body water using a leg-to-leg BIA machine.
16094082|NCT02206620|Drug|Donepezil|
16094083|NCT02206607|Drug|PF-04937319 IR MST|Immediate release material sparing tablet (IR MST) administered as 150 mg with morning meal and 100 mg with lunch
16094084|NCT02206607|Drug|PF-04937319 MR 1|Modified release formulation #1 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
16094085|NCT02206607|Drug|PF-04937319 MR 2|Modified release formulation #2 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
16094086|NCT02206607|Drug|PF-04937319 MR 3|Modified release formulation #3 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST
16094087|NCT02206594|Procedure|Descemetorhexis|
16094088|NCT02206581|Device|Hydration Monitor|
16094089|NCT02206568|Drug|URAL|
16094090|NCT02206555|Drug|emtricitabine/tenofovir disoproxil fumarate|
16094091|NCT02206542|Device|Upper limb rehabilitation robot|Upper limb rehabilitation robot is to carry out passive shoulder joint movements including shoulder flexion, shoulder abduction, shoulder horizontal-abduction and shoulder rotation.
16094092|NCT02206542|Other|Physical therapy|
16094093|NCT02206542|Device|Electroacupuncture|
16094094|NCT02206529|Behavioral|Social Network Engagement+Std Treatment|
16094095|NCT02206529|Behavioral|Standard Treatment|Standard Treatment = family-based behavioral pediatric obesity treatment, as per protocol outlined in FOCUS trial (Family Overweight: Comparing Use of Strategies; NCT00746629)
16094096|NCT02206516|Device|Transcranial Direct Current Stimulation|
16094097|NCT02206503|Drug|Cyclophosphamide|This protocol is a phase II multicenter, open label study designed to determine whether the addition of Cyclophosphamide to Rd (CRd) treatment significantly increases response rates and prolonged the outcome (PFS, OS) in patients who experienced a biochemical relapse, without CRAB under Rd treatment. The treatment period includes: administration of the combination CRd for 9 cycles. In order to assess the efficacy and safety of treatment, patients will attend the study center visits at least every 2 weeks. The response will be assessed after each cycle. During the LTFU period, after development of confirmed PD, all patients are to be followed for survival every 1-3 months via telephone or office visit.
16094098|NCT02206503|Drug|Lenalidomide|
16094099|NCT02206503|Drug|Dexamethasone|
16094100|NCT02206490|Drug|naltrexone|Randomized controlled trial of naltrexone for Gulf War Illness.
16094101|NCT02206490|Drug|Dextromethorphan|Randomized controlled trial of dextromethorphan for Gulf War Illness
16094102|NCT02206477|Drug|Dimethyl Sulfoxide|
16094103|NCT02206477|Drug|Saline 0.9%|
16094104|NCT02206464|Biological|A/Shanghai/02/2013 (H7N9) MIV|Monovalent Influenza Subvirion Vaccine for H7N9 avian influenza (H7N9 MIV)
16094105|NCT02206464|Biological|VRC-FLUDNA071-00-VP|H7 DNA Vaccine
16094106|NCT02206438|Device|Insertion of C-LMA|After induction of general anesthesia, C-LMA or Air-Q was inserted according to randomly allocated group.
16094107|NCT02206438|Device|Insertion of air-Q according|After induction of general anesthesia, C-LMA or Air-Q was inserted according to randomly allocated group.
16094108|NCT02206425|Drug|Melphalan|Melphalan will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient).
16094109|NCT02206425|Drug|Prednisone|Prednisone will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient).
16094110|NCT02206425|Drug|Cyclophosphamide|Cyclophosphamide will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient).
16094111|NCT02206425|Drug|Dexamethasone|Dexamethasone will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient).
16094169|NCT02205983|Drug|4 mg hydromorphone|We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task.
16094112|NCT02206425|Dietary Supplement|Ascorbic acid|Vitamin C will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient).
16094113|NCT02206425|Drug|PLD|Pegylated liposomal doxorubicin will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient).
16094114|NCT02206425|Drug|Lenalidomide|Lenalidomide will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient).
16094115|NCT02206425|Drug|Pomalidomide|Pomalidomide will be administered at the same schedule and dose intensity as those of the last PI-containing treatment the patient failed (it varies with each patient).
16094116|NCT02206386|Other|MHTraining-Net|See Arm Description for more details.
16094117|NCT02206386|Other|Enhanced Support|Nurses in agencies randomized to Enhanced Support have full access to the study protocol and to recorded training in the use of the protocol and depression screening posted by Brightree.
16094118|NCT02206360|Procedure|Endoscopic Ultrasound|
16094119|NCT02206360|Procedure|Magnetic Resonance Imaging (MRI)|
16094120|NCT02206347|Behavioral|attention focus|
16094121|NCT02206334|Radiation|Stereotactic Body Radiation Therapy (SBRT)|Undergo SBRT
16094122|NCT02206321|Procedure|Navigation total knee arthroplasty|computer assisted navigation total knee arthroplasty without femur intramedullary involvement
16094123|NCT02206321|Procedure|Conventional total knee arthroplasty|conventional technique with femur intramedullary violation
16094124|NCT02206308|Biological|Chimeric anti-CD20 monoclonal antibody|
16094125|NCT02206295|Drug|selexipag|
16094126|NCT02206269|Device|Alair System|The Alair system is used for doing bronchial thermoplasty.
16094127|NCT02206256|Drug|Omega-3 fatty acid capsules|2 times a day 1 capsule for 4 weeks before gastric bypass surgery
16094128|NCT02206256|Behavioral|Low calorie diet|A low calorie diet of 600 kcal/day during 2 weeks, using Modifast or an adjusted normal diet.
16094129|NCT02206243|Drug|Embozene Microspheres|Intraarterial application
16094130|NCT02206230|Radiation|Hypofractionated radiation therapy|
16094131|NCT02206230|Radiation|Standard radiation therapy|
16094132|NCT02206217|Device|Multiple-Segment spectacle lens|A multifocal spectacle lens that corrects distance refraction and provides myopic defocus images simultaneously. The myopic defocus aims at slowing down myopia progression.
16094133|NCT02206204|Drug|selexipag|
16094134|NCT02206204|Drug|placebo for selexipag|
16094135|NCT02206204|Drug|moxifloxacin|
16094136|NCT02206204|Drug|moxifloxacin-matching placebo|
16094137|NCT02206178|Drug|N-acetylcysteine combination with acetaminophen|
16094138|NCT02206178|Drug|Placebo|
16094139|NCT02206165|Drug|Candesartan 8mg|Once a day, 8 weeks
16094140|NCT02206165|Drug|Candesartan 16mg|Once a day, 8 weeks
16094141|NCT02206165|Drug|Amlodipine 5mg|Once a day, 8 weeks
16094142|NCT02206165|Drug|Amlodipine 10mg|Once a day, 8 weeks
16094143|NCT02206152|Drug|N-acetyl cysteine|N-acetyl cysteine (or saline) IV infusion given as a 150 mg/kg loading dose over the first hour and then follow that with a 50 mg/kg maintenance dose infused over the next 4 hours during a controlled hyperinsulinemic hypoglycemic insulin clamp
16094144|NCT02206152|Drug|Placebo|
16094145|NCT02206126|Behavioral|Energy Restriction|The energy restriction group was instructed to follow an energy-restricted diet (-800 kcal/day).
16094146|NCT02206113|Behavioral|Standing workstation|
16094147|NCT02206100|Drug|PER977|reversal of edoxaban-induced anticoagulation
16094148|NCT02206100|Drug|Placebo|Reversal of edoxaban-induced anticoagulation
16094149|NCT02206100|Drug|enoxaparin|
16094150|NCT02206087|Drug|PER977|Reversal of heparin-induced anticoagulation
16094151|NCT02206087|Drug|Placebo|Reversal of heparin-induced anticoagulation
16094152|NCT02206087|Drug|Heparin Sodium|
16094153|NCT02206074|Dietary Supplement|Beetroot|
16094154|NCT02206061|Behavioral|School-Based Asthma Care for Teens (SB-ACT)|
16094155|NCT02206061|Behavioral|Directly Observed Therapy|
16094156|NCT02206061|Behavioral|Asthma Education|
16094157|NCT02206048|Drug|Proflavine|0.01% proflavine solution topically applied to cervix before high-resolution microendoscopy (HRME) imaging.
16094158|NCT02206048|Procedure|High-Resolution Microendoscopy (HRME) Imaging|in-vivo high-resolution microendoscopy (HRME) images of cervical adenocarcinoma in situ (AIS) performed immediately prior to conization.
16094159|NCT02206035|Drug|Tacrolimus|Patients enrolled in the clinical trial will receive tacrolimus per institutional guidelines at doses to maintain therapeutic levels and continued until at least Day 90 posttransplant
16094160|NCT02206035|Drug|Methotrexate|Methotrexate will be dosed at 15 mg/m2 Day +1 and 10mg/m2 Days +3, +6 and +11
16094161|NCT02206035|Drug|Tocilizumab|Tocilizumab will be administered intravenously at a dose of 8 mg/kg at Day -1
16094162|NCT02206022|Drug|Remifentanil|Pain's evaluation for Remifentanil Group
16094163|NCT02206022|Drug|Placebo|CVC pain's evaluation after local anesthesia + placebo infusion
16094164|NCT02206009|Device|Collagen Membrane|First, the recipient site is prepared, and the collagen membrane hydrated. The collagen membrane is sutured firmly against the prepared vascular bed with a long-lasting suture material. The subject is requested to minimize the amount of manipulation to the area to maintain graft stability.
16094165|NCT02205996|Drug|Insulin (Humulin S)|Using insulin and glucose infusions (hyperinsulinaemic clamps), blood glucose levels were stabilised over 1 hour to reach 5 mmol/L and maintained at that level for 1 hour, then gradually reduced over 1 hour to 2.8 mmol/L and maintained at that level for 1 hour. Blood samples were collected at times 0 (baseline), 2 hours (euglycaemia), 4 hours (hypoglycaemia) and at 24 hours after the clamp studies.
16094166|NCT02205996|Device|Euglycaemic Hypoglycaemic Insulin clamp|
16094167|NCT02205983|Drug|2 mg hydromorphone|We are administering oral hydromorphone to healthy volunteers to measure its effects on the performance of a verbal task.
16094168|NCT02205983|Drug|1000 mg Acetaminophen|We are administering sublingual buprenorphine to healthy volunteers to measure its effects on the performance of a verbal task.
16094222|NCT02205671|Behavioral|Building Better Caregivers Small-group Workshop|
16094170|NCT02205983|Drug|dextrose|We are administering dextrose to healthy volunteers for our placebo group.
16094171|NCT02205970|Device|TENS|In the active group there was only one application with interactive TENS (n = 42) with the final parameters of frequency between 90 and 150pps and pulse duration between 300 and 400μs and intensity level of tolerance, lasting 35 minutes.
16094172|NCT02205970|Device|TENS (sham)|In the placebo group, there was a simulated single application, following the same procedures as the active TENS group, also for 35 minutes.
16094173|NCT02205944|Other|Progressive Handgrip Exercise|"Group 1 (Normal Exercise Group): Daily, at home for 20 minutes using an adjustable handgrip trainer up to 8 weeks prior to a scheduled surgery for fistula creation. The exercise intensity is tailored using the Borg CR100 scale (Borg & Borg, 2001).
~Group 2 (Restricted Blood Flow Exercise Group): Same as the exercise performed by Group 1 with controlled tourniquet."
16094174|NCT02205931|Other|Ketogenic diet|The ketogenic diet is a high fat diet designed to mimic the effects on the body of starvation. The premise is the main energy intake is fat, which is utilised in the body and produces ketones.
16094175|NCT02205931|Drug|Antiepileptic drug therapy|The control intervention will be drug therapy with the most appropriate further antiepileptic drug for a particular child, depending on their presenting seizures and syndrome and previous drugs used, and chosen by the expert clinician responsible for management of the patient's epilepsy.
16094176|NCT02205918|Other|Active TMS|"There will be one, 30-minute TMS session. Participants randomly assigned to this group will receive 1hz active TMS. Tics and urges will be monitored immediately before and after TMS."
16094177|NCT02205918|Other|Sham TMS|"There will be one, 30-minute TMS session. Participants randomly assigned to this group will receive inactive (sham) TMS. Tics and urges will be monitored immediately before and after TMS."
16094178|NCT02205905|Drug|14C PER977|Open-label, single dose
16094179|NCT02205892|Drug|Lupeol|Patients are supposed to apply 2% lupeol cream to one side of their face two times per day for 4 weeks. Application side is randomly determined.
16094180|NCT02205892|Drug|Placebo vehicle|Patients are supposed to apply their control vehicle cream two times per day to the other side of their face for 4 weeks. Application side is randomly determined.
16094181|NCT02205879|Drug|Pregabalin|
16094182|NCT02205879|Drug|Placebo|
16094183|NCT02205866|Other|Endometrial Receptivity Array analysis of endometrial biopsy|A biopsy of endometrium is peformed and Endometrial Receptivity Array analysis is carried out, as well as analysis of fat distribution and risk factors of Metabolic Syndrome.
16094184|NCT02205853|Other|The patient-directed (PD) strategy|The patient-directed strategy will be designed to embed the success of implementation of PCRPs by influencing the patients.
16094185|NCT02205853|Other|The multi-faceted (MF) strategy|The multi-faceted strategy will be designed to embed the success by not only influencing the patients, but also professionals and organizational aspects.
16094186|NCT02205840|Drug|SI-614|1 drop in each eye
16094187|NCT02205840|Drug|Vehicle|1 drop in each eye
16094188|NCT02205827|Other|Single-arm|collection of blood for assessment of whole blood clotting time
16094189|NCT02205814|Drug|Fasitibant- low dose|Single intra-articular injection of low dose of fasitibant
16094190|NCT02205814|Drug|Fasitibant- intermediate dose|Single intra-articular injection of intermediate dose of fasitibant
16094191|NCT02205814|Drug|Fasitibant- high dose|Single intra-articular injection of high dose of fasitibant
16094192|NCT02205814|Drug|Placebo comparator|Single intra-articular injection of placebo
16094193|NCT02205801|Procedure|Superficial Cervical Plexus Block|0.25% Marcaine is injected lateral to the sternocleidomastoid bilaterally (10mL on each side) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.
16094194|NCT02205801|Procedure|Local Wound Infiltration|0.50% Marcaine is injected at the site of incision (10mL) after induction of anesthesia and prior to incision and scheduled thyroidectomy or parathyroidectomy.
16094195|NCT02205801|Drug|0.9% saline|
16094196|NCT02205801|Drug|Marcaine|
16094197|NCT02205775|Drug|Atorvastatin|80 + 40 mg pre PCI
16094198|NCT02205775|Drug|Rosuvastatin|40 + 40 mg before PCI
16094199|NCT02205775|Drug|Rosuvastatin|5 mg twice before PCI (+ 10 mg ezetimibe)
16094200|NCT02205775|Drug|Ezetimibe|10 mg twice before PCI (+ 5 mg rosuvastatin)
16094201|NCT02205775|Drug|placebo|twice before PCI
16094202|NCT02205762|Drug|Prednisone|Stratum I
16094203|NCT02205762|Drug|Vinblastine|Stratum I
16094204|NCT02205762|Drug|mercaptopurine|Stratum I
16094205|NCT02205762|Drug|INDOMETHACIN|Indomethacin fixed dose given daily orally in two divided doses with gastric protection for total treatment duration of 24 months.
16094206|NCT02205762|Drug|Methotrexate|fixed dose weekly orally for total treatment duration of 24 months.
16094207|NCT02205762|Drug|Cytosine Arabinoside|
16094208|NCT02205762|Drug|2-chlorodeoxyadenosine|
16094209|NCT02205762|Procedure|hematopoietic stem cell transplantation (RIC-HSCT)|
16094210|NCT02205762|Biological|Intravenous immunoglobulin|
16094211|NCT02205749|Behavioral|Study-specific consent model|• Review plain language brochure describing consent to a biobank based on the study-specific model of consent
16094212|NCT02205749|Behavioral|Broad consent model|• Review plain language brochure describing consent to a biobank based on the broad model of consent
16094213|NCT02205749|Behavioral|Notice consent model|• Review plain language brochure describing consent to a biobank based on the notice model of consent
16094214|NCT02205736|Other|Breast Health Education|Small group breast health educational sessions for Latino women in home setting.
16094215|NCT02205723|Behavioral|Asthma teaching in ER|Asthma teaching
16094216|NCT02205723|Behavioral|Smartphone Asthma Control|Smartphone Asthma Control
16094217|NCT02205710|Other|Computerized cognitive training|
16094218|NCT02205710|Other|Computerized games|
16094219|NCT02205697|Behavioral|Implementation intention|The intervention consists of an implementation intention whereby subjects create a unique plan to increase their fruit and vegetable intake by planning the where, when, and what to increase their fruit and vegetable intake.
16094220|NCT02205684|Other|Computer game skills training|Playing Nintendo Wii Sports
16094221|NCT02205684|Other|Physical activity|Aerobic High Intensity Training (HIT)
16094266|NCT02205398|Drug|INC280|
16094223|NCT02205645|Device|FibroFix™ Meniscus scaffold|"The test article for this study is the FibroFix™ Meniscus scaffold supplied by Orthox Ltd. The FibroFix™ Meniscus scaffold has been developed for repair of defects of the meniscus.
~The FibroFix™ Meniscus scaffold used in this study is a silk derived product developed to functionally replace the excised unstable meniscus following a meniscal tear."
16094224|NCT02205632|Device|MPS II|
16094225|NCT02205619|Device|Air Flow Master Piezon®, EMS SA, Nyon, Swiss|comparison of different instruments on root cementum: Instrumentations with US devices ( Air Flow Master Piezon®, EMS SA, Nyon, Swiss) were performed with medium power settings and with the use of water cooling (as instructed by the manufacturer). One approximal root surface (distal and mesial) of each tooth was randomly subjected to debridement and the other approximal surface was used as control. All the instrumentations of teeth were performed by a single operator. The criteria for adequate treatment were smooth, hard root surfaces, with no remnants of calculus. The cleanliness and smoothness of the root surface were checked using a fine dental explorer. The instrumentations were done under local anesthesia.
16094226|NCT02205619|Device|Gracey curettes, American Eagle, Missoula, MT, USA|comparison of different instruments on root cementum Hand instruments (Gracey curettes 5/6, 11/12, 13/14 American Eagle, Missoula, MT, USA) were used for subgingival root instrumentation. The criteria for adequate treatment were smooth, hard root surfaces, with no remnants of calculus. The cleanliness and smoothness of the root surface were checked using a fine dental explorer. The instrumentations were done under local anesthesia.
16094227|NCT02205619|Device|Air-flow® Powder Perio, EMS SA, Nyon, Swiss|comparison of different instruments on root cementum: Instrumentations with air polishing (Air-flow® Powder Perio, EMS SA, Nyon, Swiss) were performed with a special nozzle and medium power settings and with the use of water cooling (as instructed by the manufacturer). One approximal root surface (distal and mesial) of each tooth was randomly subjected to debridement and the other approximal surface was used as control. All the measurements and instrumentations of teeth were performed by a single operator. The criteria for adequate treatment were smooth, hard root surfaces, with no remnants of calculus. The cleanliness and smoothness of the root surface were checked using a fine dental explorer. The instrumentations were done under local anesthesia
16094228|NCT02205606|Drug|HGP0816 5mg|P.O.
16094229|NCT02205606|Drug|HGP0816 10mg|P.O.
16094230|NCT02205606|Drug|HGP0816 20mg|P.O.
16094231|NCT02205606|Drug|HCP1306 5/10mg|P.O.
16094232|NCT02205606|Drug|HCP1306 10/10mg|P.O.
16094233|NCT02205606|Drug|HCP1306 20/10mg|P.O.
16094234|NCT02205593|Behavioral|Control|Regular follow-up and treatment WITHOUT behavioural intervention
16094235|NCT02205580|Drug|continuous intravenous sufentanil 0.02μg•kg-1•h-1 infusion|
16094236|NCT02205580|Drug|continuous intravenous sufentanil 0.03μg•kg-1•h-1 infusion|
16094237|NCT02205580|Drug|continuous intravenous sufentanil 0.04μg•kg-1•h-1 infusion|
16094238|NCT02205567|Dietary Supplement|Bergamot-derived product|Group 1: 500mg/day Group 2: 1000mg/day
16094239|NCT02205554|Drug|Omnitram|Nine 20 mg doses administered every 6 hours
16094240|NCT02205554|Drug|Tramadol|Nine 50 mg doses administered every 6 hours.
16094241|NCT02205554|Drug|Placebo|Nine doses administered every 6 hours.
16094242|NCT02205541|Drug|Eculizumab|"According to the patient body weight, there will be 3 to 5 injections at D0, D7, D14, D21 and D28. According to the length of initial hospital stay, patients may have the remaining injections in the day ward of the recruiting center. Dosage of ECZ will be based on previous trials using ECZ in pediatric aHUS patients.
~ECZ or placebo will be administrated intravenously as a 30-minute injection"
16094243|NCT02205541|Drug|Placebo|"According to the patient body weight, there will be 3 to 5 injections at D0, D7, D14, D21 and D28.
~ECZ or placebo will be administrated intravenously as a 30-minute injection"
16094244|NCT02205528|Drug|Liraglutide|Liraglutide will be self-administered daily via SC injection according to manufacturer specifications.
16094245|NCT02205528|Drug|Metformin|Metformin hydrochloride immediate- or extended-release oral tablets will be supplied by the participant or investigational site as standard-of-care treatment beginning at least 8 weeks prior to randomization and throughout the 12-week treatment period. Metformin will also be continued during the 4-week follow-up. Dose selection will be based upon manufacturer specifications.
16094246|NCT02205528|Drug|Placebo|Matching placebo to NNC0090-2746 will be self-administered daily via SC injection.
16094247|NCT02205528|Drug|NNC0090-2746|NNC0090-2746 solution will be self-administered in daily doses of 1.8 mg via SC injection.
16094248|NCT02205515|Drug|Everolimus|Everolimus is a novel derivative of rapamycin.
16094249|NCT02205502|Drug|Lidocaine|Normal saline will be injected subcutaneously as a placebo for lidocaine in study group of children.
16094250|NCT02205502|Drug|Normal saline|
16094251|NCT02205489|Drug|Alemtuzumab GZ402673|Pharmaceutical form:concentration for solution Route of administration: intravenous infusion
16094252|NCT02205489|Drug|cetirizine|Pharmaceutical form:tablet Route of administration: oral
16094253|NCT02205489|Drug|ranitidine|Pharmaceutical form:tablet Route of administration: oral
16094254|NCT02205489|Drug|methylprednisolone|Pharmaceutical form:tablet Route of administration: oral
16094255|NCT02205489|Drug|methylprednisolone|Pharmaceutical form:solution Route of administration: intravenous
16094256|NCT02205489|Drug|aciclovir|Pharmaceutical form:tablet Route of administration: oral
16094257|NCT02205489|Drug|esomeprazole|Pharmaceutical form:tablet Route of administration: oral
16094258|NCT02205489|Drug|ibuprofen|Pharmaceutical form:tablet Route of administration: oral
16094259|NCT02205489|Drug|paracetamol|Pharmaceutical form:tablet Route of administration: oral
16094260|NCT02205476|Drug|PF-06473871|Subjects who previously were randomized in B5301001 study will go under a second revision surgery followed by 4 administration of PF-06473871.
16094261|NCT02205476|Drug|PF-06473871|Subjects who previously were randomized in B5301001 study will go under a second revision surgery followed by 3 administration of PF-06473871.
16094262|NCT02205463|Drug|KD019|
16094263|NCT02205450|Drug|Recombinant Somatropin|
16094264|NCT02205411|Device|HeartAssist 5® VAD System|The HeartAssist 5® VAD System is a small, implantable pump that is designed to increase blood flow for patients who have heart failure. The device is intended to support patients in the hospital or at home.
16094265|NCT02205411|Device|Control VAD|The HeartMate II® VAD or HVAD®
16094274|NCT02205333|Biological|MEDI6469 Monotherapy|single intravenous (IV) administration of MEDI6469
16094275|NCT02205333|Biological|MEDI6469 Plus Tremelimumab|MEDI6469 in combination with Tremelimumab
16094276|NCT02205333|Biological|MEDI6469 Plus Durvalumab|MEDI6469 in combination with Durvalumab
16094277|NCT02205333|Biological|MEDI6469 plus Rituximab|MEDI6469 in combination with Rituximab
16094278|NCT02205320|Biological|DRL_PG|
16094279|NCT02205320|Biological|Pegfilgrastim Form A|
16094280|NCT02205320|Biological|Pegfilgrastim Form B|
16094281|NCT02205307|Device|PINPOINT|
16094282|NCT02205307|Device|SPY Elite|
16094283|NCT02205294|Other|Osteopathic Treatment|The osteopathic treatment will be a gentle hands treatment using myofascial release techniques.
16094284|NCT02205281|Behavioral|Lifestyle Intervention|The intervention is a multi-component program designed to prevent excessive gestational weight gain in overweight and obese women and to promote weight loss in their non-pregnant overweight and obese partners through modifications of diet, exercise, and behavioral strategies during pregnancy.
16094285|NCT02205268|Procedure|Near infrared spectroscopy neurofeedback training|
16094286|NCT02205255|Drug|Azithromycin|From day 1 up to and including day 3: 500 mg azithromycin or placebo PO once a day From day 4 up to and including day 90: 250 mg azithromycin or placebo PO once every 2 days
16094287|NCT02205255|Drug|Placebo|
16094288|NCT02205242|Drug|Azithromycin|From day 1 up to and including day 3: 500 mg azithromycin or placebo PO once a day From day 4 up to and including day 90: 250 mg azithromycin or placebo PO once every 2 days
16094289|NCT02205242|Device|Dynaport®|Registering physical activity during 7 days post discharge from hospital (0 months), 3 months and 9 months
16094290|NCT02205242|Drug|Placebo|
16094291|NCT02205229|Drug|Multi-ingredient, topical compounded medications|
16094292|NCT02205216|Device|Active tDCS|anode over the motor and premotor cortex with cathodes placed over both mastoids. TDCS will be applied for 20 minutes at 2 mA.
16094293|NCT02205216|Device|Sham tDCS|"anode and cathode placed 1 cm apart over the forehead and DC (1mA) applied for 1-2 min, short-circuited through the skin creating the same temporary tingling sensation without effects on the brain."
16094294|NCT02205216|Behavioral|Rehabilitation Therapy|"All patients will undergo a rehabilitation therapy intervention (2x a week for 4 weeks = 8 intervention sessions) with simultaneous sham or active tDCS. The trained physiotherapist will follow a standardized program with checklist. Each of the 8 training session will last approximately 45min. The rehabilitative interventions include:
~cognitive training: attentional strategies (mental counting, mental obstacle)
~transfer training: everyday activities
~motor training (walking) with sensory cueing (visual, acoustic, cane, ball) The rehabilitation therapy is divided into two sessions both including a 5 minutes warm-up and the learning of cueing and movement strategies based on different modalities (cognitive, visual, tactile and auditory)."
16094295|NCT02205203|Device|Mayo Clinic Anxiety Coach|Mayo Clinic Anxiety Coach is a smartphone application based on cognitive-behavioral treatment for anxiety disorders (i.e., exposure-based therapy) that can be used as 1) a stand-alone treatment requiring minimal provider contact, and 2) an augmentation of face-to-face treatment that increases clinician fidelity and patient adherence to evidence-based treatment. The design of Anxiety Coach is based on evidence and theory suggesting that information and communication technologies (ICTs) are well-suited for encouraging behavior change through 1) scheduled reminders to engage in therapeutic exercises, 2) point of performance support, 3) individually tailored information, 4) real-time symptom assessment, and 5) readily accessible asynchronous communication.
16094296|NCT02205203|Other|Treatment as Usual|In the TAU condition therapists provide treatment consistent with their orientation and clinical judgment. Previous research suggests that TAU will include supportive therapy, relaxation, and cognitive restructuring. The format of treatment will be 6 to 12, 50-minute, face-to-face therapy sessions in the therapist's office, with flexibility to leave the office (e.g., for exposure).
16094297|NCT02205190|Drug|Fimasartan|
16094298|NCT02205190|Drug|Rosuvastatin|
16094299|NCT02205190|Drug|Fimasartan/Rosuvastatin combination|
16094300|NCT02205177|Device|Mayo Clinic Anxiety Coach|Mayo Clinic Anxiety Coach is a smartphone application based on cognitive-behavioral treatment for anxiety disorders (i.e., exposure-based therapy) that can be used as 1) a stand-alone treatment requiring minimal provider contact, and 2) an augmentation of face-to-face treatment that increases clinician fidelity and patient adherence to evidence-based treatment. The design of Anxiety Coach is based on evidence and theory suggesting that information and communication technologies (ICTs) are well-suited for encouraging behavior change through 1) scheduled reminders to engage in therapeutic exercises, 2) point of performance support, 3) individually tailored information, 4) real-time symptom assessment, and 5) readily accessible asynchronous communication.
16094301|NCT02205164|Drug|Palonosetron + Aprepitant|Aloxi 0.25mg Emend 125/80/80 mg
16094302|NCT02205164|Drug|Palonosetron|Aloxi 0.25mg
16094303|NCT02205151|Drug|Fimasartan|
16094304|NCT02205151|Drug|Amlodipine|
16094305|NCT02205151|Drug|Fimasartan/Amlodipine combination|
16094306|NCT02205138|Drug|ALLOB® cells with ceramic scaffold|Each patient will undergo a single administration of ALLOB®/ceramic scaffold mix into the lumbar interbody fusion site under anaesthesia
16094309|NCT02205099|Drug|SKL15508|
16094310|NCT02205099|Drug|Placebo|
16094311|NCT02205086|Other|Diagnosis|"Unaided: The testers will record a differential diagnosis consisting of a list of diseases and their ranking and a prioritized list of test orders, as well as the most appropriate referral for further evaluation and treatment of the patient.
~Aided: Then testers will enter the case into diagnostic decision support software and after getting advice from the software, the testers will record the same information as in Unaided, but allowing for the possibility that responses could differ as a result of using the software."
16094312|NCT02205073|Drug|Placebo RD + AVP SD|Placebo (matching to study drug) repeat doses + intranasal AVP single dose
16094313|NCT02205073|Drug|Placebo RD + Placebo SD|Placebo (matching to study drug) repeat doses + intranasal Placebo (matching to intranasal AVP) single dose
16094314|NCT02205073|Drug|RG7314 RD + AVP SD|RG7314 repeat doses + intranasal AVP single dose
16094315|NCT02205060|Other|virtual reality exposure treatment|
16094321|NCT02205047|Procedure|gastrectomy|D2 gastrectomy
16094322|NCT02205034|Drug|oxytocin|Intranasal administration
16094323|NCT02205021|Other|No intervention|
16094324|NCT02205008|Procedure|surgery|Total or subtotal gastrectomy with D2
16094325|NCT02205008|Drug|adjuvant systemic chemotherapy|adjuvant systemic chemotherapy with S-1 (<1.25m2:40mg, 1.25-1.5m2:50mg, >1.5m2:60mg, bid)
16094326|NCT02205008|Drug|Early postoperative intraperitoneal chemothgerapy|"operation day: 0.9％ saline solution 1L plus mitomycin C 10 mg/m2
~1 - 4 postoprative day: 0.9％ saline solution 1L plus 5-FU 700 mg/m2 plus sodium bicarbonate 50 mEq"
16094327|NCT02204995|Procedure|Trapeziectomy with LRTI|Trapeziectomy with Ligament Reconstruction and Tendon Interposition
16094328|NCT02204995|Procedure|Trapeziectomy|Trapeziectomy
16094329|NCT02204982|Drug|Duvelisib|PI3K Inhibitor
16094330|NCT02204982|Drug|Placebo|Matching Placebo (25 mg BID) administered orally in 28-day continuous treatment cycles.
16094331|NCT02204982|Drug|Rituximab|IV infusion of rituximab (375 mg/m2) once weekly for 4 weeks during Cycle 1, then once on Day 1 of Cycles 4, 6, 8, and 10.
16094332|NCT02204969|Dietary Supplement|Lithia water|"Experimental: Lithia spring water Lithia water (active) for 4 weeks then placebo water for 4 weeks Intervention: Dietary Supplement: Lithia water
~Placebo Comparator: Natural spring water Placebo water for 4 weeks then lithia water (active) for 4 weeks Intervention: Dietary Supplement: Natural spring water with negligible lithium levels"
16094333|NCT02204969|Device|Transcranial Magnetic stimulation|All participants will receive standard medical therapy for AD. In addition, patients recruited for the study will receive 16 sessions of TMS with the H2 coil over 8 weeks. The first group will receive excitatory stimulation of 10 Hz over the prefrontal and parietal cortex, the second group will receive inhibitory stimulation of 1 Hz over similar brain areas and control patients will receive the same amount of Sham sessions. Patient will receive 3 treatments per week in the first 3 weeks and then 1 treatment per week for additional 4 weeks.
16094334|NCT02204956|Behavioral|Sustained Care|The Sustained Care intervention includes four main components: 1. a 40-minute individual session about quitting smoking during the hospital stay; 2. a 90-day telephone-based and text messaging program that provides support regarding smoking and nicotine patch use; 3. the opportunity, during the automated calls and texts to be transferred to quit smoking resources, including live telephone quit coaching counseling, web and text-based quit coaching resources; and 4. an 8-week supply of nicotine patches, provided at no cost.
16094335|NCT02204956|Behavioral|Usual Care|Usual Care includes a brief, 5 - 10 minute education session about quitting smoking, delivered by a hospital nurse during the hospital stay. Written handouts to reinforce the educational session will also be provided.
16094336|NCT02204943|Device|Biomarker analysis|Pharmacodynamic study of Radium-223 in bone biopsy and circulating tumor cell samples
16094337|NCT02204943|Drug|Administration of radium-223|Subjects will receive radium-223 treatment for their disease as standard of care in this protocol. They will be receiving this treatment regardless of their participation in this protocol.
16094338|NCT02204930|Drug|PeproStat|A solution of PeproStat containing up to 9.25mg protein soaked immediately prior to use onto a Gelita-Spon® gelatin sponge.
16094339|NCT02204917|Drug|OPTISON|Contrast enhanced Voiding Urosonography (ceVUS) with intravesical administration of OPTISON for vesicoureteral reflux detection and urethral imaging in children. Voiding Cystourethrography (VCUG) examination will be subsequently performed as part of the standard care.
16094340|NCT02204904|Genetic|Allo-HSCT|Allogeneic Hematopoietic Stem Cell Transplantation
16094341|NCT02204891|Dietary Supplement|Probiotics in SIBO|Mixture of the four probiotics in one capsule. One capsule twice daily for 30 days
16094342|NCT02204891|Dietary Supplement|Probiotics|One capsule twice daily for 30 days
16094343|NCT02204878|Drug|Parecoxib Sodium|Dynastat 40mg was given before anesthesia. PCA will be attached right before closing abdomen. Concentration of sufentanil is 1ug/ml. PCA settings: 1) no background infusion; 2) bolus 2ml sufentanil each; 3) with the lockout time 5 min, 1 hour limit: 10ml. Dynastat 40mg Q12h will be given within 72 hours after surgery
16094344|NCT02204865|Device|Pacemaker/ICD|Implantation of an ICD or CRT device with ApneaScan function
16094345|NCT02204852|Drug|Iloprost+eptifibatide|
16094346|NCT02204852|Drug|Placebo|
16094347|NCT02204839|Drug|Basal insulin dose|
16094348|NCT02204826|Drug|Korean Red Ginseng (KRG)|"The KRG capsules were provided by Korean Ginseng Corporation (Daejeon, Korea). KRG powder was manufactured from roots of a 6-year-old red ginseng, Panax ginseng Meyer, harvested in Republic of Korea. KRG was made by steaming fresh ginseng at 90-100 ◦C for 3 h and then drying at 50-80 ◦C.
~KRG powder prepared from grinded red ginseng (KRG capsule : 500mg/capsule). KRG was analyzed by high-performance liquid chromatography. KRG extract contained major ginsenoside-Rb1: 4.26mg/g, -Rb2: 1.62mg/g, -Rc: 1.80mg/g, -Rd: 0.29mg/g, -Re: 1.71mg/g, -Rf: 0.67mg/g, -Rg1: 2.61mg/g, -Rg2: 0.20mg/g, -Rg3: 0.13mg/g, and other minor ginsenosides. During the study period, three capsules were taken daily for 12 weeks."
16094349|NCT02204826|Procedure|Varicocelectomy|Surgical microscope-assisted varicocelectomy using the subinguinal approach was conducted by a single surgeon.
16094350|NCT02204813|Drug|Placebo|"A liquid mixed meal containing 1.5 grams of acetaminophen will be ingested in 7 equal portions from 0-30 minutes.
~Starting at minus 15 minutes, an intravenous infusion of albumin alone (placebo) will be administered for 5.25 hours."
16094351|NCT02204813|Drug|Lo-Xenin|"A liquid mixed meal containing 1.5 grams of acetaminophen will be ingested in 7 equal portions from 0-30 minutes.
~Starting at minus 15 minutes, an intravenous infusion of xenin-25 at a dose of 4 pmoles/kg/min will be administered for 5.25 hours."
16094352|NCT02204813|Drug|Hi-Xenin|"A liquid mixed meal containing 1.5 grams of acetaminophen will be ingested in 7 equal portions from 0-30 minutes.
~Starting at minus 15 minutes, an intravenous infusion of xenin-25 at a dose of 12 pmoles/kg/min will be administered for 5.25 hours."
16094353|NCT02204813|Drug|Extra Hi-Xenin|"A liquid mixed meal containing 1.5 grams of acetaminophen will be ingested in 7 equal portions from 0-30 minutes.
~Starting at minus 15 minutes, an intravenous infusion of xenin-25 at a dose of 24 pmoles/kg/min will be administered for 5.25 hours."
16094354|NCT02204787|Device|transcranial direct current stimulation|
16094355|NCT02204761|Radiation|Proton Beam Radiation Therapy|Undergo proton beam re-irradiation therapy
16094356|NCT02204748|Device|DePuy Attune posterior stabilizing fixed bearing knee system|
16094357|NCT02204735|Behavioral|Eat majority of calories in the morning|
16094358|NCT02204735|Behavioral|Eat the majority of calories in the evening|
16094359|NCT02204722|Drug|600mg/day of Imatinib|
16094360|NCT02204722|Drug|400mg/day of Imatinib|
16094361|NCT02204709|Other|2N Trout|Diploid/2N trout source
16094362|NCT02204709|Other|3N Trout|Triploid/3N trout source
16094363|NCT02204709|Other|Tilapia|Tilapia/control fish source
16094364|NCT02204696|Procedure|Tonsillectomy|Study participants will be scheduled for tonsillectomy based on clinical indications, with the need for surgery determined prior to study enrollment and not based on study enrollment.
16094365|NCT02204683|Drug|Aflibercept|Intravitreal aflibercept
16094366|NCT02204670|Other|Acute release of irisin after a single exercise session.|We will determine the amount of Irisin secreted after a single bout of resistance exercise. Participants will be stratified into 3 groups based on the degree of Irisin release during this acute bout of resistance exercise. The metabolic adaptations to the 4 weeks of resistance training will be compared between youth stratified according to the amount of Irisin released during the acute bout of resistance exercise.
16094367|NCT02204657|Device|Continuous Glucose Monitoring System|Patients in the intervention group will receive Continuous Glucose Monitoring(CGMS) at weeks 28, 32 and 36 and have the CGMS reviewed at weeks 29, 33 and 37 and management adjusted based on the CGMS readings
16094368|NCT02204644|Drug|Flumatinib 600mg qd|
16094369|NCT02204644|Drug|Imatinib 400mg qd|
16094370|NCT02204631|Other|Head and Neck Educational Handbook|
16094371|NCT02204618|Device|cochlear implantation|
16094372|NCT02204618|Other|6 months initial abstention|Our experimental protocol relies on real life therapeutic strategy, where a cochlear implant may be proposed once CROS and bone conductions systems have failed. Thus, all subjects enrolled in our study will try CROS and bone conduction devices. If these trials are ineffective, the remaining subjects will be randomized between two arms (cochlear implantation vs 6 months abstention followed by cochlear implantation).
16094373|NCT02204605|Behavioral|Video-based Consensus Opinion|
16094374|NCT02204579|Drug|NPSP795|
16094375|NCT02204566|Device|OFDI Capsule|Imaging of the esophagus using the OFDI Capsule and system
16094376|NCT02204553|Drug|Panobinostat|Treating patients with relapsed and/or refractory Multiple Myeloma
16094377|NCT02204540|Behavioral|Mock study intervention|Participants will swallow a pill and consume food in a mock research study, while their performance of the task is being monitored.
16094378|NCT02204527|Dietary Supplement|supplementation of 100.000 IU of vitamin D3|supplementation of vitamin D ( with 2 pills of Addera D3 (50.000IU each pill))
16094379|NCT02204527|Dietary Supplement|placebo pill|Placebo
16094380|NCT02204514|Procedure|Surgery for external snapping hip|
16094381|NCT02204501|Drug|Midazolam 5mg Syrup|"All twenty four subjects will receive 5 mg midazolam syrup at four different time points during the study for a total of four non-subsequent dosing days.
~On Study Days 0 and 12, subjects will receive only 5 mg midazolam syrup dosed in the morning.
~On Study Days 6 and 9, subjects will have 5 mg midazolam syrup co-administered with their assigned dose of vapendavir in the morning. Co-administration of midazolam will not occur at the time of the evening dose for Group B."
16094382|NCT02204501|Drug|Vapendavir 264 mg BID|Twelve subjects (6 male and 6 female) will receive 264 mg vapendavir (achieved with two 132 mg vapendavir capsules) BID daily as divided dose given in the morning and evening 12 hours apart for seven days.
16094383|NCT02204501|Drug|Vapendavir 528 mg QD|Twelve subjects (6 male and 6 female) will receive 528 mg vapendavir (achieved with four 132 mg vapendavir capsules) QD in the morning for seven days
16094384|NCT02204488|Procedure|Total Joint Arthroplasty|Total Joint Arthroplasty with device: Maïa® trapezio-metacarpal joint prosthesis, Groupe Lépine, Genay, France
16094385|NCT02204488|Procedure|Trapeziectomy|Trapeziectomy
16094386|NCT02204475|Drug|Grazoprevir/Elbasvir|Participants take a fixed-dose combination of grazoprevir 100 mg and elbasvir 50 mg once daily (QD) by mouth (PO).
16094387|NCT02204475|Drug|Boceprevir|Participants take Boceprevir (BOC) 800 mg three times daily (TID) PO.
16094388|NCT02204475|Drug|PegIntron|Participants take 1.5 mcg/kg PegIntron (P) once weekly (QW) via subcutaneous injection.
16094389|NCT02204475|Drug|Ribavarin|Participants take Ribavarin (R) 800-1400 mg (depending on body weight) twice daily (BID) PO.
16094390|NCT02204462|Drug|FBnTP|A PET imaging radiotracer
16094391|NCT02204449|Behavioral|Cardiac Rehabilitation Peer Mentorship|
16094392|NCT02204436|Other|Emulsion and gel|A fixed similar quantity of both emulsion and gel were applied consequentially on the hand twice a day, in the morning and in the evening (preferentially always at the same hour), with a mild massage, until complete absorption, for 8 weeks.
16094393|NCT02204423|Procedure|Trans-Radial Percutaneous Coronary Intervention (TR-PCI)|
16094394|NCT02204410|Dietary Supplement|Omega-3 Fatty Acid|
16094395|NCT02204410|Drug|ADHD Medication|
16094396|NCT02204397|Drug|INGAP Peptide, Ustekinumab|
16094397|NCT02204384|Other|HFD Meal: High fiber from food|High amount of fiber from diet food sources (HFD; total fiber 9.7g; soluble fiber 5.4g)
16094398|NCT02204384|Dietary Supplement|HFS Meal: High fiber from supplement|High amount of soluble fiber from guar gum supplement (HFS; total fiber 9.1g; soluble fiber 5.4g) - sachet 5 g Fiber Mais, Nestlé Brasil, São Paulo, BR
16094399|NCT02204384|Other|UF Meal: usual amount of fiber|Usual amount of fiber (UF; total fiber 2.4g; soluble fiber 0.8g)
16094400|NCT02204371|Drug|Pazopanib|Pazopanib is available as 50 mg and 200 mg tablets to be administered orally once daily in the morning at least one hour before or two hours after a meal for 12 weeks
16094401|NCT02204371|Drug|Placebo|Pazopanib matching placebo is available as tablets to be administered orally once daily in the morning at least one hour before or two hours after a meal for 12 weeks
16094482|NCT02203773|Drug|Azacitidine|Azacitidine will be administered by IV infusion over 10 to 40 minutes or subcutaneously based on the institutional guidelines, beginning on Day 1 through Day 7 of each Cycle, for a minimum of 4 Cycles.
16094483|NCT02203760|Drug|Pazopanib plus Gemcitabine|Pazopanib 800 mg orally once daily plus Gemcitabine 1000 mg/m2 i.v. over 30 min d 1 and d 8 q3w or
16094484|NCT02203760|Drug|Pazopanib|Pazopanib 800 mg orally once daily
16094485|NCT02203747|Other|Administration of patient self-assessment|
16094540|NCT02203487|Drug|BIIF 1149 BS - single rising dose|
16094541|NCT02203487|Drug|Placebo|
16094402|NCT02204358|Procedure|autologous bone marrow stem cells|"Before considering whether patients meet the inclusion criteria, they are diagnosed with severe intrauterine adhesions uterus, endometrial dysplasia. And after that there will be history taking, physical examination, chromosome examination, B-ultrasound examination, hysteroscopy examination and so on.
~If patients agree to participate, they will receive a bone marrow stem cells collection and separation of adhesions by hysteroscopy surgery. Postoperative observation period is about three months, including B-ultrasound examination once a month and hysteroscopy after 3 months. According to the endometrial conditions, the doctor will select an appropriate time for pregnancy and follow-up. The doctor may also require patients to do some unscheduled visits."
16094403|NCT02204345|Drug|Carboplatin|Carboplatin by intravenous infusion q3w for 4-6 cycles and thereafter as per investigator's discretion.
16094404|NCT02204345|Drug|Paclitaxel|Paclitaxel by intravenous infusion q3w until disease progression, death, unacceptable toxicity or withdrawal of consent.
16094405|NCT02204345|Drug|RO5479599|RO5479599 will be administered as an intravenous infusion q3w until disease progression, death, unacceptable toxicity or withdrawal of consent.
16094406|NCT02204332|Drug|Cabazitaxel|
16094407|NCT02204332|Other|Best Supportive Care|
16094408|NCT02204319|Device|Cold laser|Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 milliWatt, 635 nanometer red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device.
16094409|NCT02204306|Genetic|TSER|TS gene will be genotyped for each patients prior to chemotherapy. Patients will be assigned to different arms according to specific TSER genotype.
16094410|NCT02204293|Drug|Canakinumab|Canakinumab, single-dose 4 mg/kg up to 300 mg administered subcutaneously.
16094411|NCT02204293|Drug|Placebo|Matching placebo administered subcutaneously.
16094412|NCT02204267|Other|prolonged ECG monitoring|Start of long-term ECG immediately after admission to the stroke unit by using a portable ECG recorder for a max. duration of 7 days (or hospital discharge)
16094413|NCT02204267|Device|ECG|
16094414|NCT02204254|Device|Radiofrequence|Associated to arm radiofrequence
16094415|NCT02204254|Drug|Doxycycline|doxycycline 100 mg / day for 3 months with clinical evaluation, photos, and confocal SSSB V1 and V4 (M6). Tour V2 M1 for clinical evaluation of safety review, collection of adverse events and issuing end of treatment. Visit V3 M3 on adverse effects.
16094416|NCT02204241|Drug|Carfilzomib|
16094417|NCT02204241|Drug|Cyclophosphamide|
16094418|NCT02204241|Drug|Dexamethasone|
16094419|NCT02204228|Device|TITAN™ Reverse Shoulder System (TRS)|All patients will be operated on with the TITAN™ Reverse Shoulder System (TRS).
16094420|NCT02204215|Device|electric acupuncture|Electric acupuncture therapy was made on LI4, LI11, ST36, and ST41 on four limbs for each patient, 30 min for each time, twice per day. Starting from the beginning of mechanical ventilation, to the weaning of the mechanical ventilation.
16094421|NCT02204215|Other|conservative|General treatment, without electric acupuncture, include passive range-of-motion exercise，q2H turning，minimizing the use of sedation, etc.
16094422|NCT02204202|Drug|[18F]FDG|10 millicuries (mCi) of [18F]FDG will be injected intravenously at the start of a 60-minute dynamic PET scan acquisition
16094423|NCT02204202|Drug|[18F]ISO-1|8 mCi of [18F]ISO-1 will be injected intravenously at the start of a 60-minute dynamic PET scan acquisition
16094424|NCT02204189|Drug|TongFuSan|TongFuSan 1g
16094425|NCT02204176|Other|Exercise info|"Discussion:
~benefits of exercise
~types of exercise
~exercise guidelines
~components of an exercise session
~how to reduce risk of injuries"
16094426|NCT02204176|Other|Implementation intentions|"Discussion of:
~barriers to exercise and how to address/overcome barriers
~how to create detailed exercise plans"
16094427|NCT02204176|Other|Industriousness|"Discussion of:
~realistic monitoring of efforts related to exercise
~reaching and pushing past thresholds for sustained effort for exercise"
16094428|NCT02204176|Device|pedometer|
16094429|NCT02204163|Drug|Eutropin|
16094430|NCT02204163|Drug|Genotropin|
16094431|NCT02204150|Device|OFDI Capsule|Imaging of the esophagus using the OFDI Capsule and system
16094432|NCT02204137|Other|Falls Risk Questionnaire|
16094433|NCT02204137|Other|Cancer and Aging Research Group Geriatric Assessment|
16094434|NCT02204137|Other|Falls Efficacy Scale-International (FES-1)|
16094435|NCT02204137|Other|Health Related Quality of Life using the Functional Assessment of Cancer Therapy - Gynecologic Oncology Group Neurotoxicity Scale (FACT GOG/NTX)|
16094436|NCT02204124|Device|Thunderbeat|Thunderbeat uses ultrasonic and high frequency bipolar energy simultaneously to seal and cut tissue compared to placebo comparator.
16094437|NCT02204124|Device|Standard of care scissors, ligatures, clips, and sutures|
16094438|NCT02204111|Other|Intervention|Individualized treatment proposals (e.g. pain therapy, physiotherapy, psychological contact) from expert consensus, based on Patient Reported Outcomes
16094439|NCT02204098|Biological|Mammaglobin-A DNA Vaccine|
16094440|NCT02204098|Procedure|Optional biopsy|
16094441|NCT02204085|Drug|GO-203-2c|
16094442|NCT02204085|Drug|GO-203-2c + Decitabine|
16094443|NCT02204072|Drug|BI 836845|
16094444|NCT02204072|Drug|Enzalutamide|
16094445|NCT02204072|Drug|Enzalutamide|
16094446|NCT02204059|Drug|hMAb BIWA 4|
16094447|NCT02204046|Drug|BIWA 4|
16094448|NCT02204033|Drug|99mTc - labelled hMAb BIWA 4|
16094449|NCT02204033|Drug|186 Re - labelled hMAb BIWA 4|
16094450|NCT02204033|Drug|unlabelled hMAb BIWA 4 - low dose|
16094451|NCT02204033|Drug|unlabelled hMAb BIWA 4 - medium dose|
16094452|NCT02204033|Drug|unlabelled hMAb BIWA 4 - high dose|
16094486|NCT02203734|Procedure|Moderate Pressure Massage|The massage therapy will begin with the mother in a side-lying position, with pillows positioned behind her back and between her legs for support. The massage is given in the following sequence and repeated twice (10 minutes on each side for 20 minutes total) on the following areas: 1) Head and neck: 2) Back: 3) Arms: and 4) Legs. The effective moderate pressure (measured by a pressure meter) is 8 db or a slight indentation in the skin.
16094542|NCT02203474|Drug|Tiotropium HFA BAI 5 mcg|
16094543|NCT02203474|Drug|Tiotropium 18 mcg Capsule|
16094544|NCT02203474|Drug|Placebo|Placebo
16094453|NCT02204020|Drug|5-azacytidine (5-aza) maintenance therapy after transplant|The planned initial dose of 5-aza is 32mg/m2 (Level 0) administered either subcutaneously or intravenously for days 1 through 5 of a 28-day cycle, which will be initiated between day+30 and day+100 after HCT. Patients who tolerate this dose based on hematologic parameters and with no SAEs for two consecutive cycles will be eligible for a dose escalation to 50mg/m2 (Level +1). Patients who tolerate this dose based on the same criteria as above for two consecutive cycles will be eligible for a dose escalation to 75mg/m² (Level +2). Patients will continue at dose Level +2 for the remainder of the study provided there are no toxicities that require dose reduction. Patients requiring a dose reduction are not eligible for re-escalation.
16094454|NCT02204007|Device|3D imaging & surrogate bone model|3D imaging & surrogate bone model to assist with acetabular shell placement. Different that standard of care preoperative imaging
16094455|NCT02203994|Device|"Duolith® SD 1 T-Top (Storz Medical AG, Switzerland)"|2000 pulses per muscle, energy level: 0.030 mJ/mm2, frequency: 4 Hz
16094456|NCT02203968|Drug|Fibrinogen concentrate|Six grams of fibrinogen concentrate (RiaSTAP™) will be administered intravenously as a single 300ml rapid infusion (less than 3min) via level I automated pressure pump within one hour of hospital admission.
16094457|NCT02203968|Drug|Placebo Comparator|Placebo Comparator: Normal saline Placebo (normal saline) will be administered intravenously as a single 300ml rapid infusion (less than 3min) via level I automated pressure pump within one hour of hospital admission.
16094458|NCT02203955|Drug|Short-Chain Fructooligosaccharide|4 chews (8.0 g scFOS) orally for 12 months
16094459|NCT02203955|Drug|Maltodextrin|4 chews (maltodextrin) daily for 12 months
16094460|NCT02203942|Other|NAAT testing|comparison of NAAT testing for BV, VVC and trich to Amsel criteria, Nugent score, yeast culture and TV culture.
16094461|NCT02203916|Drug|Azilsartan medoxomil|Azilsartan medoxomil tablets
16094462|NCT02203916|Drug|Azilsartan medoxomil placebo|Azilsartan medoxomil placebo-matching tablets
16094463|NCT02203903|Biological|Tumor associated antigen lymphocytes (TAA-T)|TAA-T may be generated from donors or recipients and will be tested for specificity to 3 tumor antigens commonly found in hematological malignancies (WT1, PRAME, and SURVIVIN,). The goal of this cell infusion will be to initiate an immune response to residual leukemia or lymphoma that includes multiple antigens and may prevent tumor evasion (through decreased expression of a single antigen).
16094464|NCT02203877|Dietary Supplement|Lactobacillus fermentum CECT5716|Intervention with a probiotic strain in form of a daily capsule containing 3x109cfu/capsule.
16094465|NCT02203877|Dietary Supplement|Maltodextrin|Intervention with a daily capsule containing maltodextrin as placebo
16094466|NCT02203864|Biological|BIBW2 component A|BIBW2 without IL-2 secreting cell line
16094467|NCT02203864|Biological|BIBW2 component B|BIBW2 with IL-2 secreting cell line
16094468|NCT02203851|Drug|Risankizumab|Risankizumab administered by subcutaneous (SC) injection
16094469|NCT02203838|Drug|RBP-7000|"120-mg RBP-7000 dose delivered by subcutaneous injection every 28 days for a total of 13 injections (for roll-over participants, the first two injections took place under study RB-US-09-0010).
~A one-time down-titration to 90 mg RBP-7000 is permitted at the investigator's discretion should the participant have tolerability issues. Participants who received the 90-mg dose of RBP-7000 and exhibited a worsening in psychiatric symptoms could receive a one-time up-titration back to 120 mg RBP-7000 at the discretion of the investigator.
~RBP-7000 is a combination of the ATRIGEL Delivery System and risperidone. The ATRIGEL Delivery System allows for sustained-release of risperidone in a controlled manner."
16094470|NCT02203825|Biological|CM-CS1 T-cell infusion|Each patient will receive a single dose of CM-CS1 T-cells by intravenous infusion.
16094471|NCT02203812|Drug|Probiotic Arm|Each Inersan lozenge contains at least 1 billion colony forming unit of Lactobacillus brevis CD2
16094472|NCT02203812|Drug|Placebo Arm|Placebo lozenges contain all ingredients except the active constituent (probiotic, Lactobacillus brevis CD2)
16094473|NCT02203799|Biological|Peanut Oral Immunotherapy (POIT)|The peanut protein is ingested in the form of peanut flour. Peanut flour will be given in small pre-measured soufflé cups containing the amount of peanut flour that needs to be eaten for one dose. One dose will be taken per day. Dosage of the peanut flour will begin with 1.8 mg of peanut protein during the initial visit or the lowest tolerated dose on initial challenge and increased every 2 during the build-up phase until the maintenance dose of peanut protein (3900 mg) is reached.
16094474|NCT02203786|Drug|Haloperidol|"Dose/maximum dose = 3-mg; route = oral. Participants assigned to the haloperidol antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between individual doses).
~Dose 1: 3 visually identical capsules, each containing 1 mg haloperidol."
16094475|NCT02203786|Drug|Fluphenazine|"Dose/maximum dose = 3-mg; route = oral. Participants assigned to the fluphenazine antagonist group will receive 2 doses (@ 3 mg) on alternate sessions (with minimum of 2 weeks between individual doses).
~Dose 1: 3 visually identical capsules, each containing 1 mg fluphenazine."
16094476|NCT02203786|Drug|Dexedrine|"Dose/maximum dose = 20-mg; route = oral. All participants will receive 2 doses (@ 20 mg) during Phase II - sessions 3, 4, with minimum 1 week between individual doses.
~Dose 2: when participants reach expected peak blood levels for dose 1, they will receive their second dose. On sessions 3 and 4 (Phase II), the dose will consist of 2 visually identical capsules each containing 10 mg D-amphetamine."
16094477|NCT02203786|Drug|Placebo|"Dose 1: On alternate sessions (1 and 3 or 2 and 4, depending on counterbalancing) participants will receive 3 visually identical placebo (lactose) capsules.
~Dose 2: when participants reach expected peak blood levels for dose 1, they will receive their second dose. On sessions 1 and 2 (Phase I), this will consist of 2 dummy capsules, visually identical to those administered for dose 1."
16094478|NCT02203786|Behavioral|Slot Machine|15 minute play of a commercial slot machine game in bar-simulated laboratory setting.
16094479|NCT02203773|Drug|Posaconazole|Posaconazole will be administered orally twice a day on Cycle 1 Day 21 and once daily from Cycle 1 Day 22 to Cycle 1 Day 28.
16094480|NCT02203773|Drug|ABT-199|ABT-199 is taken orally once daily starting on Day 2 of cycle 1 and begin on day 1 of every other cycle thereafter. This is a dose escalation study, therefore the dose of ABT-199 will change.
16094481|NCT02203773|Drug|Decitabine|Decitabine will be administered by IV infusion over 1 hour beginning on Day 1 thru Day 5 of each Cycle for a minimum of 4 Cycles
16094537|NCT02203513|Drug|LY2606368|105 mg/m^2 IV once every 14 days of a 28 day cycle
16094538|NCT02203500|Drug|Lacidipine|
16094487|NCT02203734|Procedure|Light Pressure Massage|The light pressure massage group will receive light pressure massage in contrast to the treatment group who will receive moderate pressure massage. As with moderate pressure massage, each session will begin with the mother in a side-lying position, with pillows positioned behind her back and between her legs for support. The massage is given in the following sequence and repeated twice (10 minutes on each side for 20 minutes total) on the following areas: 1) Head and neck: 2) Back: 3) Arms: and 4) Legs.
16094488|NCT02203721|Device|TECNIS Symfony Extended Range of Vision IOL, Model ZXR00|
16094489|NCT02203721|Device|TECNIS Monofocal IOL, Model ZCB00|
16094490|NCT02203708|Other|Supportive Program for Mother with BPD (SuPMother-B).|"The development of the program is based on several principles: group process, groupware, mentalization, parental values, behavioral strategies and information on the child's needs, knowledge of the BPD and the strategies of get better. The program will last 10 sessions of group of about 2h.
~Minimal intervention. All study participants receive an individual interview about 45 minutes with a psychiatrist for three objectives: information on the diagnosis of BPD, information on resources for health care and educational aids."
16094491|NCT02203695|Drug|Enzalutamide|Enzalutamide (MDV3100) 160 mg PO once daily for 6 months (2 months prior to SRT, 2 months during SRT and 2 months following SRT)
16094492|NCT02203695|Radiation|SRT|Salvage radiation therapy (3D-CRT (Three dimensional conformal radiation therapy)/IMRT) 66.6-70.2 Gy given 1.8 Gy M-F for 37 -39 fx
16094495|NCT02203669|Other|Home therapy|Study subjects complete home therapy independently for four (4) weeks based on handouts of exercises adapted for post-operative breast reconstruction patients along with an instructional handout for stretching complied by a certified occupational therapist.
16094496|NCT02203669|Other|Structured In-Office Therapy|Study subjects will participate in Structured In-Office Therapy twice a week for four (4) weeks. Each visit will last approximately sixty (60) minutes. Subjects will receive therapy instruction by a certified occupational therapist on upper extremity stretching, relaxation, cardio rehabilitation, and strength training. These subjects will also receive exercise and stretching handouts to use at home between therapy visits.
16094497|NCT02203656|Drug|Placebo|placebo supplement
16094498|NCT02203656|Dietary Supplement|Nutritional Supplement|protein supplement
16094499|NCT02203656|Behavioral|In-home exercise|In-home exercise program
16094500|NCT02203656|Drug|Testosterone|Testosterone injection
16094501|NCT02203643|Drug|Carfilzomib|
16094502|NCT02203643|Drug|Cyclophosphamide|
16094503|NCT02203643|Drug|Lenalidomide|
16094504|NCT02203643|Drug|Dexamethasone|
16094505|NCT02203630|Drug|Phenylephrine|Phenylephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock
16094506|NCT02203630|Drug|Norepinephrine|Norepinephrine, in intravenous formulation, will be administered as the primary vasopressor for the treatment of septic shock
16094507|NCT02203617|Behavioral|Educational Content/Pediatric Anticipatory Guidance|educational information from Bright Futures Guidelines for Health Supervision for birth to 18 months
16094508|NCT02203617|Behavioral|Book provision|Given free books prenatally and at 2, 4, 6, 9, 12, and 18 months postpartum
16094509|NCT02203604|Biological|aldesleukin|Given IV
16094510|NCT02203604|Biological|ipilimumab|Given IV
16094511|NCT02203604|Other|laboratory biomarker analysis|Correlative studies
16094512|NCT02203591|Drug|3M CHG/IPA Prep C|Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
16094513|NCT02203591|Drug|3M CHG/IPA Prep CH|Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
16094514|NCT02203591|Drug|ChloraPrep|Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
16094515|NCT02203591|Drug|Normal Saline|Apply topically for 30 seconds to the abdominal region or 2 minutes to the inguinal region, and allow to dry for 3 minutes.
16094516|NCT02203578|Drug|romidepsin|Given IV
16094517|NCT02203578|Other|laboratory biomarker analysis|Correlative studies
16094518|NCT02203565|Drug|Dakin's solution|Applied topically
16094519|NCT02203565|Radiation|radiation therapy|Undergo radiation therapy
16094520|NCT02203565|Other|questionnaire administration|Ancillary studies
16094521|NCT02203565|Other|laboratory biomarker analysis|Optional correlative studies
16094522|NCT02203552|Drug|minocycline hydrochloride|100 mg bid given by mouth for 9 weeks
16094523|NCT02203552|Other|placebo|Placebo given by mouth for 9 weeks
16094524|NCT02203552|Other|laboratory biomarker analysis|Correlative blood levels for cortisol, high sensitivity c-reactive protein (hs-CRP) and inflammatory factors including but not limited to IL-6, TNF-α, IL-1β, and MCP-1 will also be obtained weekly on protocol.
16094525|NCT02203552|Other|Questionnaire administration|The CES-D and STAI will be administrated weekly.
16094526|NCT02203539|Other|exposure to normal light|exposure for 60 minutes in duration
16094527|NCT02203539|Other|exposure to bright light|exposure to bright light for 60 minutes of duration
16094528|NCT02203539|Other|exposure to blue-enriched light|exposure to blue-enriched light for 60 minutes of duration
16094545|NCT02203461|Drug|Tenofovir disaproxil fumarate/emtricitabine/elvitegravir/cobicistat|STRIBILD® QD, d1-14
16094546|NCT02203461|Drug|Tenofovir disaproxil fumarate/emtricitabine + Lopinavir/ritonavir|Truvada®/ Kaletra® 200/50 mg QD, d1-14
16094547|NCT02203461|Drug|Tenofovir disaproxil fumarate/emtricitabine + ritonavir-boosted darunavir|Truvada®/Prezista® 800 mg/Norvir®100 mg Medication, QD, d1-14
16094548|NCT02203448|Device|Facet Wedge spinal system|
16094549|NCT02203422|Drug|Cyclosporin A|given orally at a dose of 1.5-2.0mg/kg twice daily for 3 consecutive months, adjusted to maintain serum levels between 200-400 ng/ml and tapered by 50 mg/d per week if patients achieved a complete response.
16094550|NCT02203422|Drug|rhTPO|given subcutaneously at a dose of 300 Units/kg for 14 consecutive days, following with a flexible dosage depending on platelet count until the 29th day
16094551|NCT02203409|Procedure|Laparoscopic ALPPS|Laparoscopic Associating Liver Partition and Portal Vein Ligation for Two-stage Hepatectomy
16094552|NCT02203396|Drug|rabbit ATG, Cyclosporine, Levamisole|rATG is administered at a dose of 1.97 mg/kg/day for 9 days CSA is administered orally at a dose of 3 mg/kg qod Levamisole is administered orally at a dose of 2.5 mg/kg qod. The CSA and LMS is designed to alternately every other day.
16094553|NCT02203383|Device|CRT Implantation|Implantation of a biventricular pacemaker or defibrillator.
16094554|NCT02203370|Device|NIRS - Near-infrared spectroscopy|
16094555|NCT02203357|Biological|Hepatitis B vaccine|Hepatitis B vaccine, 60 μg/1ml recombinant hepatitis B vaccine,20 μg/1ml recombinant hepatitis B vaccine, Shenzhen Kangtai Biological Products Co, LTD.
16094556|NCT02203331|Drug|Placebo|Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
16094557|NCT02203331|Drug|Levonorgestrel|Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
16094558|NCT02203331|Drug|Anastrozole|Participants received Anastrozole 300 µg/d or 600 µg/d or 1050 µg/d + Levonorgestrel 40 µg/d intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Placebo 3-months depot intramuscular injection
16094559|NCT02203331|Drug|Lupron / Leuprolide acetate|Placebo intravaginal ring (treatment for 84 days, 28 days wearing period for each ring) and Lupron / Leuprolide acetate 11.25 mg 3-months depot intramuscular injection
16094560|NCT02203305|Device|Cochlear Implant|cochlear implantation used a treatment for single-sided deafness and/or asymmetric hearing loss
16094561|NCT02203305|Other|Control Group|Subjects in the control group will have had listening experience with a bone-conduction device, which is an approved treatment for SSD.
16094562|NCT02203292|Behavioral|Liberal transfusion strategy|Patients will have red blood cells transfused only if Hb < 9.0 g/dL
16094563|NCT02203292|Behavioral|Restrictive transfusion strategy|Patients will have red blood cells transfused only if Hb < 7.0 g/dL
16094564|NCT02203279|Other|Rebase II Fast|It is going to be used a direct relining material
16094565|NCT02203279|Other|Flexacryl|This is going to be used as a second direct relining material
16094566|NCT02203279|Other|Vertex|This is going to be used as an indirect relining material
16094567|NCT02203266|Device|Feedback|Feedback on the patient's own inhaler use, with personalized information on the patients technique and timing of use of the diskus inhaler as recorded on the INCA device will be provided to patients in the feedback group after 1,2 and 6 months.
16094568|NCT02203266|Behavioral|Education|Feedback on the patient's own inhaler technique as observed by pharmacist and education to support best use will be provided to patients in the demonstration group after 1,2 and 6 months.
16094569|NCT02203253|Drug|Thalidomide|100 mg by mouth twice a day on days 1-5 after chemotherapy, cycle 1
16094570|NCT02203253|Drug|Placebo for thalidomide|Placebo tablet manufactured to mimic Thalidomide 25 mg tablet 100 mg by mouth twice a day on days 1-5 after chemotherapy , cycle 1
16094571|NCT02203253|Drug|Palonosetron and Dexamethasone|Palonosetron 0.25 mg intravenously on day 1; Dexamethasone 12 mg by mouth or intravenously before chemotherapy on day 1 and 8 mg on days 2-4; cycle 1.
16094572|NCT02203240|Other|Cocoa|
16094573|NCT02203240|Other|Placebo|
16094574|NCT02203227|Dietary Supplement|Placebo|
16094575|NCT02203227|Dietary Supplement|BioTurmin (Curcuma longa rhizomes extract)|
16094576|NCT02203227|Dietary Supplement|BioTurmin-WD (Water dispersible curcuminoids)|
16094577|NCT02203227|Dietary Supplement|MaQxan|
16094578|NCT02203214|Device|Ligamys|All patients are treated with Ligamys within 21 days after injury. The Ligamys implant has to be used in accordance with the instructions for use.
16094579|NCT02203188|Procedure|Lid debridgement scaling|
16094580|NCT02203175|Drug|saline|Before the anesthesia induction, 5 ml isotonic saline
16094581|NCT02203175|Drug|fentanyl|before the anesthesia induction 50 mcgr fentanyl
16094582|NCT02203175|Drug|propofol|during anesthesia 50 mg proposal with 50 mcgr fentanyl
16094583|NCT02203162|Device|electronic cigarette exposure|30 puffs of a disposable electronic cigarette, 30 seconds apart.
16094584|NCT02203149|Drug|Grazoprevir|One or two 50 mg tablets (depending on randomization) taken orally once daily for 12 weeks.
16094585|NCT02203149|Drug|Elbasvir|One 50 mg tablet taken orally once daily for 12 weeks.
16094586|NCT02203149|Drug|Placebo to Grazoprevir|One tablet of placebo matched to grazoprevir, taken orally once daily for 12 weeks.
16094587|NCT02203149|Drug|Placebo to Elbasvir|One tablet of placebo matched to elbasvir, taken orally once daily for 12 weeks.
16094588|NCT02203136|Procedure|Tissue Biopsy|During bladder cancer surgery, tissue specimen taken for molecular profiling.
16094589|NCT02203136|Procedure|Magnetic Resonance Imaging (MRI)|3 Tesla pelvic magnetic resonance imaging (MRI) performed four weeks after bladder cancer surgery.
16094590|NCT02203123|Device|Ultrasound|
16094591|NCT02203123|Drug|normal saline|
16094592|NCT02203097|Procedure|Partial pressure of CO2 at the end of an exhaled breath|Three previously defined EtCO2 levels (partial pressure of CO2 at the end of an exhaled breath) were adjusted during anesthesia.
16094593|NCT02203097|Drug|Propofol|Propofol is administered to all patients via target-controlled infusion (TCI) to reach 4 mcg/ml constant plasma concentration according to the Schneider model during the course of the narcosis.
16094631|NCT02202837|Drug|etanercept|etanercept 1 x 50 mg/week or 2 x 25mg/week
16094594|NCT02203084|Other|Social Determinants Questionnaire|The questionnaire contains a general background information section common to all medical conditions. It then contains separate sections with medical condition specific questions.
16094595|NCT02203058|Other|Pursed-lips breathing|Expiration with pursed-lips during functional capacity tests.
16094596|NCT02203058|Other|No pursed-lips breathing|To avoid pursed-lips breathing, subjects use a a mouthpiece (2cm diameter X 2cm length) such as the one used in pulmonary functional tests.
16094597|NCT02203045|Other|Total Knee Arthroplasty|
16094598|NCT02203032|Drug|Ustekinumab|45 mg or 90 mg given by subcutaneous injection at Weeks 0 and 4 for all participants. Participants with an IGA score of 0 or 1 at Week 16 will also receive ustekinumab every 12 weeks (q12w) from Week 16 to Week 40.
16094599|NCT02203032|Drug|Guselkumab|100 mg given by subcutaneous injection at Weeks 16 and 20 and every 8 weeks (q8w) thereafter through Week 44.
16094600|NCT02203032|Drug|Placebo for ustekinumab|Subcutaneous injection at Weeks 16, 28, and 40 to maintain the blind for participants randomized to treatment with guselkumab.
16094601|NCT02203032|Drug|Placebo for guselkumab|Subcutaneous injection at Weeks 16 and 20 and q8w thereafter through Week 44 to maintain the blind for participants randomized to treatment with ustekinumab.
16094602|NCT02203019|Drug|Propofol|Propofol will be administered for sedation in mechanically ventilated patients with sepsis.
16094603|NCT02203019|Drug|Dexmedetomidine|Dexmedetomidine will be administered for sedation in mechanically ventilated patients with sepsis.
16094604|NCT02203019|Drug|Fentanyl|"Fentanyl will be administered for analgesia in mechanically ventilated patients with sepsis. The use of Fentanyl is not an intervention of interest."
16094605|NCT02203006|Biological|OVIHD|7 ml of blood will be taken during a follow-up consultation and kept in a biological collection. Clinical data will be collected in a database.
16094606|NCT02202993|Drug|Mibefradil with Radiation|"Patients will receive mibefradil dihydrochloride, which will be dose escalated from 150mg/day until the maximum tolerated dose (MTD) is determined, or until a dose of 350 mg/day is reached using a standard 3 + 3 design. Mibefradil dihydrochloride will be dosed orally in 4 divided doses per day for 17 consecutive days to the MTD.
~This will be given concurrently with hypofractionated radiation therapy."
16094607|NCT02202980|Drug|LDV/SOF|90/400 mg FDC tablet administered orally once daily
16094608|NCT02202980|Drug|RBV|Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16094609|NCT02202980|Drug|SOF/VEL|400/100 mg FDC tablet administered orally once daily
16094610|NCT02202980|Drug|VOX|100 mg tablet administered orally once daily with food
16094611|NCT02202967|Drug|Misoprostol|Misoprostol oral tablets/ capsules contain 200 mcg of Misoprostol, a synthetic prostaglandin E1 analog
16094612|NCT02202967|Drug|Placebo|Placebo contains lactose granules
16094613|NCT02202954|Other|Guided Self-rehabilitation Contract|"In Guided Self-rehabilitation Contracts, the therapist acts as a coach, in the sports' sense, providing double guidance: technical, selecting and teaching the required exercises to the patient using infrequent thorough visits, for example every month; Psychological, binding with the patient on the contract.
~The patient agrees to perform the prescribed daily stretch postures and rapid alternating movements over the long term and to document this work in a written diary."
16094614|NCT02202941|Other|Procalcitonin guided treatment|Patients who will be randomized to arm will receive antibiotics therapy based on procalcitonin measurement on day 1, 3, 5, 7, 9, 11 and 13.
16094615|NCT02202941|Other|Conventional treatment|Patients who will be randomized to this arm will receive antibiotic therapy based on conventional practice.
16094616|NCT02202928|Biological|DC-CIK|8×10^9 autologous tumor lysate pulsed DC-CIK cells for each infusion, IV (in the vein) for four cycles, each cycle received four infusions with a 1 day interval.
16094617|NCT02202928|Radiation|Radiotherapy|45~50 Gy in 25-28 fractions.
16094618|NCT02202928|Drug|Chemotherapy|Oxaliplatin 85mg/m2 IV over 2 hours, day 1; Leucovorin 400mg/m2 IV over 2 hours, day 1; 5-FU 400mg/m2 IV bolus on day 1, then 1200mg/m2/day for 2 days IV continuous infusion; Repeat every 2 weeks.
16094619|NCT02202915|Behavioral|Behavioral Checklist|
16094620|NCT02202902|Other|1H magnetic resonance spectroscopy and CMRI|Metabolic status of the patients evaluated by an OGTT (measuring plasma glucose, insulin and plasma nonesterified fatty acids concentrations) and myocardial Imaging and spectroscopy will be performed before and 6 month after treatment
16094621|NCT02202902|Other|1H magnetic resonance spectroscopy and CMRI|Metabolic status of the patients evaluated by an OGTT (measuring plasma glucose, insulin and plasma nonesterified fatty acids concentrations) and myocardial Imaging and spectroscopy will be performed before treatment
16094622|NCT02202889|Behavioral|Adequate Calcium Today|A school-randomized behavioral intervention study called the Adequate Calcium Today (ACT) project was conducted in sixth grade classrooms located in six states (Arizona, California, Hawaii, Indiana, Nevada, and Ohio).
16094623|NCT02202876|Other|Oral Glucose Tolerance Test|1.75 gm/kg to a maximum of 75 gm of an oral glucose solution
16094624|NCT02202876|Other|High Glycemic Index Meal|"isocaloric breakfasts - set the high glycemic index to 80
~The nutrient composition of each meal will be 10 kcal per kg, 50% kcal from carbohydrates, 20% kcal from protein, and 30% kcal from fat"
16094625|NCT02202876|Other|Low Glycemic Index Meal|"isocaloric breakfasts - set the low glycemic index to 30
~The nutrient composition of each meal will be 10 kcal per kg, 50% kcal from carbohydrates, 20% kcal from protein, and 30% kcal from fat"
16094626|NCT02202876|Other|Test Soda|Test soda containing 60% fructose and 40% glucose at a dose of 1.75 grams per kilogram body weight to a maximum of 75 grams.
16094627|NCT02202876|Other|Fruit juice|Fruit juice containing a combination fructose, glucose, and sucrose at a dose of 1.75 grams per kilogram body weight to a maximum of 75 grams
16094628|NCT02202863|Dietary Supplement|Red wine grape pomace flour (WGPF)|Pomace, a byproduct from wine production, was obtained from red wine grapes, Cabernet Sauvignon, vintage 2011, Maipo Valley, Chile, after alcoholic fermentation. The wine grape pomace was dried and grounded to obtain the flour. Intervention group ate 20 g per day of this flour, which contained 10 g of dietary fiber and an antioxidant capacity of 7,258 ORAC units.
16094629|NCT02202850|Drug|etanercept|etanercept 1 x 50 mg/week or 2 x 25mg/week
16094630|NCT02202850|Drug|etanercept|etanercept 1 x 50 mg/week or 2 x 25mg/week
16094717|NCT02202226|Drug|Placebo|
16094632|NCT02202837|Drug|etanercept|etanercept 1 x 50 mg/week or 2 x 25mg/week
16094633|NCT02202824|Other|Survey questionnaire|Each of the scale versions elicits personal attitudes toward intimate partner violence and perceived norms about intimate partner violence, in a different fashion
16094634|NCT02202811|Behavioral|Forced Desynchrony|all sleep opportunities and other activities will be scheduled by the experimenter so that by the end of the study these activities are spread evenly across all phases of the internal body clock.
16094635|NCT02202798|Device|Syringe device|
16094636|NCT02202785|Drug|MLN0264|MLN0264 IV infusion
16094637|NCT02202772|Drug|Cabazitaxel|Intravesical instillation of the Cabazitaxel for 2 hours
16094638|NCT02202772|Drug|Gemcitabine|Intravesical instillation of Gemcitabine for 2 hours
16094639|NCT02202772|Drug|Cisplatin|Intravesical installation of Cisplatin for 2hours
16094640|NCT02202759|Drug|MLN0264|MLN0264 IV infusion
16094641|NCT02202746|Drug|Lucitanib|Lucitanib is a potent, orally available selective inhibitor of the tyrosine kinase activity of fibroblast growth factor receptors (FGFR1-3), vascular endothelial growth factor receptors (VEGFR1-3), and platelet-derived growth factor receptors alpha and beta (PDGFR alpha and beta)
16094642|NCT02202733|Other|Cooking|The aim is to test the feasibility of a skill-based cooking intervention to reduce the consumption of foods prepared away from home for the evening meal (e.g., pre-prepared frozen foods, restaurant foods, fast food, take-out), energy intake from evening meals, and parent/child weight status.
16094643|NCT02202720|Drug|Sevoflurane|Short term sedation with sevoflurane in ICU
16094644|NCT02202707|Drug|Gabapentin|Study medication, gabapentin, will be distributed to all study participants and participants will be instructed as to how to take and titrate the medication dose. Participants will take gabapentin daily for up to six weeks.
16094645|NCT02202694|Behavioral|Culturally Adapted Cognitive behavior therapy|This 12 session Multimodal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component
16094646|NCT02202681|Device|OFDI Capsule|Imaging of the duodenum with the OFDI capsule and system
16094647|NCT02202668|Device|TRS|"TRS measurements of subcutaneous deep wound soft tissue and underlying bone will be collected at the same standard locations that are used to measure wound dimensions. The probe will never be in contact with the wound, but we will sterilize the probe head in advance in order to ease potential concerns regarding equipment sterility. A single point TRS measurement can be obtained in less than 60 seconds. At a minimum we will collect measurements at the geometric center of the wound as well as at the 6 and 12 and 3 and 9 ulcer coordinates. These coordinates are commonly used to estimate ulcer dimensions. It is anticipated that the PhAT probe will be used with a beam diameter of 7.5 mm. It is possible that the incident laser beam diameter will need to be adjusted (7.5 mm to 6.0 mm) to accommodate smaller wounds. If incident laser beam diameter adjustment is necessary we will also adjust the laser intensity to maintain the maximum permissible exposure of 0.3 W/cm2 per ANSI guidelines."
16094648|NCT02202642|Procedure|collagenase|Cultured limbal stem cells transplantation
16094649|NCT02202629|Other|Beverage containing plant based extracts|Intervention involves single exposure, oral consumption of test article following baseline measurements
16094650|NCT02202616|Drug|Glycopyrronium /Indacaterol maleate|Glycopyrronium 50mcg/Indacaterol maleate 110mcg once daily by a breezhaler device
16094651|NCT02202603|Drug|Teriparatide|single oral tablet
16094652|NCT02202603|Drug|Teriparatide|subcutaneous standard injection
16094653|NCT02202603|Drug|placebo|Oral placebo
16094654|NCT02202590|Device|SECM Capsule|Imaging of the esophagus using the SECM capsule and system
16094655|NCT02202577|Drug|Chlorhexidine - Isopropyl alcohol|Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA
16094656|NCT02202577|Drug|Povidone-Iodine Scrub and Paint|Applied to skin pre-operatively for surgical site anti-sepsis; regulated as a drug by FDA
16094657|NCT02202564|Procedure|LT|Orthotopic LT
16094658|NCT02202564|Drug|ADV-TK|
16094659|NCT02202564|Drug|ganciclovir|
16094660|NCT02202551|Drug|ADS-5102|
16094661|NCT02202538|Device|Indego|Indego
16094662|NCT02202525|Drug|Micardis®|
16094663|NCT02202525|Drug|Other hypertensives|
16094664|NCT02202512|Drug|Placebo|tablets
16094665|NCT02202512|Drug|Cimetidine|
16094666|NCT02202512|Drug|Placebo|tablets
16094667|NCT02202512|Drug|Placebo|tablets
16094668|NCT02202512|Drug|BI 1060469 high dose|tablets
16094669|NCT02202512|Drug|BI 1060469 low dose|tablets
16094670|NCT02202512|Drug|Naproxen|
16094671|NCT02202512|Drug|BI 1021958|tablets
16094672|NCT02202499|Drug|Varenicline|All participants will take the following dose of varenicline: 0.5 mg once a day on days 1-3, 0.5 mg twice a day on days 4-7, and 1 mg twice a day through week 16 of the study. Arm descriptions show specific details for each group.
16094673|NCT02202499|Other|Counseling and Support Materials|Counseling and support materials (including a review and self-monitoring workbook tentatively titled, Winding Down: A Guide to Quitting Smoking using Varenicline) instructing participants to systematically utilize the FE techniques provided.
16094674|NCT02202499|Other|Laboratory Assessments|The first laboratory assessment will consist of completion of questionnaires and a cue-reactivity test. The second laboratory assessment will be scheduled for the end of the week before the participant's quit date. It will involve completion of questionnaires and another cue reactivity test. A follow-up session conducted by research staff will occur one month after the target quit date to collect information about each participant's current smoking status, smoking rate, varenicline use, and opinion about the treatment. A second follow-up session will be conducted by telephone and will occur three months after the target quit date, at the end of varenicline use. At the end of the study, participants will be asked to complete a brief survey asking basic information, similar to the questions during the screening period.
16094675|NCT02202486|Other|Brain MRI|Brain MRI with gadolinium contrast
16094676|NCT02202473|Drug|Lamivudine|
16094677|NCT02202473|Drug|Lamivudine+Oxymatrine Capsules|
16094718|NCT02202213|Drug|Placebo|
16094719|NCT02202213|Drug|Lu AF11167|
16094883|NCT02201004|Drug|placebo|Pharmaceutical form:tablet Route of administration: oral
16094884|NCT02200991|Drug|LIXISENATIDE AVE0010|Pharmaceutical form:solution Route of administration: subcutaneous
16094678|NCT02202447|Drug|EC1169|"PART A: EC1169 - Dose dependent on cohort, IV (in the vein) on days 1 and 8 of each 21 day cycle for the QW schedule.
~PART B: EC1169 cohort 1 - taxane naive - Recommended Phase 2 dose, IV (in the vein) on days 1 and 8 of each 21 day cycle for the QW schedule.
~PART B: EC1169 cohort 2 - taxane exposed - Recommended Phase 2 dose, IV (in the vein) on days 1 and 8 of each 21 day cycle for the QW schedule."
16094679|NCT02202447|Other|EC0652|PART A AND B: EC0652 is in development as a radioimaging agent for PSMA-expressing tumors. All patients receive a baseline 99mTc-EC0652 SPECT/CT scan for PSMA expression prior to Cycle 1 Day 1.
16094680|NCT02202434|Device|Lotus Valve System|Procedure: Transcatheter aortic valve replacement (TAVR)
16094681|NCT02202434|Device|CoreValve/Evolut R Transcatheter Aortic Valve Replacement System|Procedure: Transcatheter aortic valve replacement (TAVR)
16094682|NCT02202434|Device|LOTUS Edge Valve System|Procedure: Transcatheter aortic valve replacement (TAVR)
16094683|NCT02202421|Behavioral|Targeted Applied Behavior Analysis (T-ABA)|Participants will be enrolled in a five week Targeted Applied Behavior Analysis (T-ABA) parent therapy group. T-ABA parent groups will be 1.5 hours in length. Following the five weeks of parent group sessions, parents will participate in five weekly one-hour parent-therapist sessions in which a therapist will work one-on-one with the parent and their child. One treatment group (T-ABA Parent Group plus Individual Therapy) will also receive eight one-hour individual therapist-child applied behavior analysis therapy sessions concurrent with the parent group and parent-therapist sessions. The second treatment group (T-ABA Parent Training Only) will be offered eight one hour individual therapist-child applied behavior analysis sessions at the conclusion of the study if desired.
16094684|NCT02202408|Drug|SKI2670|Oral, Single Dose
16094685|NCT02202408|Drug|Placebo|Same shape as the experimental drug
16094686|NCT02202395|Drug|LTS 0.25mg|use LTS 0.25mg/d
16094687|NCT02202395|Drug|LTS 0.5mg|use LTS 0.5mg/d
16094688|NCT02202395|Drug|LTS 1.0mg|use LTS 1.0mg/d
16094689|NCT02202395|Drug|Placebo|use placebo once daily
16094690|NCT02202382|Drug|Korean Red Ginseng, Varicocelectomy|
16094691|NCT02202382|Drug|Placebo|Placebo were provided by Korean Ginseng Corporation (Daejeon, Korea). The placebo capsules were identical in shape, color, and taste.
16094692|NCT02202382|Procedure|Varicocelectomy|Surgical microscope-assisted varicocelectomy using the subinguinal approach was conducted by a single surgeon.
16094693|NCT02202369|Other|Multimodal Analgesia Treatment|Subjects are given medications preop (Pregabalin, Oxycodone, Acetaminophen, Transdermal Scopolamine, Cyclobenzaprine), intraop (Propofol induction, Sevoflorane maintenance, Dexamethasone, Fentanyl, Ketamine, Marcaine, Zofran) and postop(Acetaminophen, Pregabalin, Tramadol, Cyclobenzaprine) that implement a multi-modal approach to managing pain.
16094694|NCT02202369|Other|Standard of Care Pain Management Protocol|Subjects will be treated with patient controlled (standard of care) narcotic analgesia for pain management. (Marcaine, Dexamethasone, Zofran, Morphine, Acetaminophen, Cyclobenzaprine)
16094695|NCT02202356|Drug|ALS-008176|
16094696|NCT02202356|Drug|Placebo|
16094697|NCT02202343|Behavioral|school based health and nutrition education|
16094698|NCT02202330|Other|Video Arm|"5 minute videos, on various stroke related topics/ themes delivered in one session before discharge from the hospital (list topics on which videos have to made)
~Discussion and questions and answers after viewing video to ensure that core message has been understood and there are no lacunae in understanding the message of video.
~Phone card - a memory chip installed in the cell phones of intervention team that ensures that the videos can be replayed at home to refresh memory of some details that may not have been captured in the mandatory viewing sessions."
16094699|NCT02202317|Device|PET/CT Scan|Subjects will receive a PET/CT Scan in addition to SPECT imaging, from the level of the lower chest to the lower pelvis, typical of an abdominal CT, usually within 1-3 hours after Yttrium-90 treatment.
16094700|NCT02202304|Drug|Chlorhexidine/Thymol varnish|This will be applied on abutment teeth on partial denture wearers every 3 months during a period of 2 years.
16094701|NCT02202291|Genetic|Demonstration of genetic mutations causing Raynaud's phenomenon|"Such an approach allows to highlight chromosomal regions shared only by individuals within a family and thus highlight the genetic mutations causing the Raynaud phenomenon . The ultimate goal is to identify new pathways involved in vasospasm.
~Patients with primary Raynaud phenomenon will be identified during a consultation of vascular medicine and internal medicine in one of the centers participating to the study. Those patients with a primary PR will be considered as Index cases.
~The investigators will conduct genealogical trees of index cases to identify families, whose number of healthy individuals and those with relevant PR makes sense for a family genetic study, i.e. a genetically informative family."
16094702|NCT02202265|Dietary Supplement|Olive oil|30ml a day of olive oil
16094703|NCT02202265|Dietary Supplement|Nuts|30g a day of nuts
16094704|NCT02202265|Dietary Supplement|Control diet|Diet based on standard guidelines
16094705|NCT02202252|Procedure|Insertion of a single drain|A negative pressure drain will be inserted below the lower flap directing to the axilla.
16094706|NCT02202252|Procedure|Insertion of double drains|Two drains will be inserted into the axilla and below the lower flap in the double drains group.
16094707|NCT02202252|Procedure|Ultrasonography after removal of the drains|One day after removal of the drains seroma under the flaps and in the axilla will be examined by ultrasonography.
16094708|NCT02202239|Drug|midazolam|Before induction, midazolam 0.05mg/kg will be injected intravenously.
16094709|NCT02202239|Drug|Penehyclidine Hydrochloride Injection|Penehyclidine Hydrochloride 0.01mg/kg will be injected intravenously after midazolam is injected.
16094710|NCT02202239|Drug|Etomidate|Induction dose: 0.3 mg/kg. Maintenance dose: 10 μg•kg-1•min-1.
16094711|NCT02202239|Drug|Propofol|Induction dose: 2.0 mg/kg. Maintenance dose: 4 to 6 mg/kg/h.
16094712|NCT02202239|Drug|Fentanyl|During induction, after injection of etomidate, fentanyl 3 μg/kg will be given intravenously.
16094713|NCT02202239|Drug|Cisatracurium Besilate|"Cisatracurium Besilate 0.14 mg/kg will be used after fentanyl is injected for induction.
~During maintenance, intermittent bolus of cisatracurium will be used for maintain muscle relaxation."
16094714|NCT02202239|Drug|Remifentanil|Remifentanil will be injected continuously during maintenance of anesthesia.
16094715|NCT02202239|Drug|Sevoflurane|Sevoflurane of 1% to 2% will be administered via inhalation to keep bispectral index（BIS) between 50 to 55.
16094716|NCT02202226|Drug|Lu AF35700|
16094720|NCT02202200|Drug|PD- 0332991|"PD-0332991 Inhibitor of cyclin-dependant kinase (CDK) 8 schedules will be evaluated PD-0332991 PO QD either at 25 mg, 50 mg, 75 mg, 100 mg, 125 mg, 150 mg, 175 mg and 200 mg
~All patients will receive vemurafenib as background therapy ,bid at 720mg bid for the first group (during the first 2 cycle then 960 mg bid if good tolerance) and 960mg bid for all other patients"
16094721|NCT02202187|Drug|GSK2140944|Investigational Study Drug
16094722|NCT02202187|Other|Placebo|Placebo
16094723|NCT02202174|Device|Supraglottic Airway Device|
16094724|NCT02202161|Drug|GSK2330672|GSK2330672 will be available in 10 mg, 20 mg, 30 mg, and 90 mg oral solution to be administered BID for 14 days. Subjects are to drink contents of dosing bottle (45 ml) followed by 2 x 50 ml rinses of bottle and then an additional 95 ml water for a total volume of 240 ml consumed
16094725|NCT02202161|Drug|Placebo|Matching placebo will be available as oral solution to be administered for 14 days, BID. Subjects are to drink contents of dosing bottle (45 ml) followed by 2 x 50 ml rinses of bottle and then an additional 95 ml water for a total volume of 240 ml consumed
16094726|NCT02202161|Drug|Sitagliptin|Sitagliptin will be available as film-coated tablets Tablet of 50 mg to be administered orally, BID, for 14 days
16094727|NCT02202161|Drug|Metformin|Metformin will be available as 850 mg white to off-white, film-coated tablets; to be administered BID orally during run-in through Day 14
16094728|NCT02202135|Drug|Ceftaroline fosamil|IV ceftaroline 600mg every 8 hours
16094729|NCT02202135|Drug|Vancomycin|IV vancomycin 15mg/kg every 12 hours
16094730|NCT02202135|Drug|Aztreonam|IV aztreonam 1 g every 8 hours
16094731|NCT02202122|Other|OSA Scoring|Comparison of the preoperative OSA scoring (STOP-BANG, DES-OSA, P-SAP and OSA50) with the postoperative mortality at one month.
16094732|NCT02202109|Behavioral|CHW and Self-sampling for Cervical Cancer|Behavioral: CHW and Self-sampling for Cervical Cancer The intervention strategies will involve one home visit: 1) provide brief health education on cervical cancer screening, 2) provide and collect self-sampler test. We envision visits lasting no more than 60 minutes.
16094733|NCT02202109|Behavioral|Mailed Self Sampler|Mailed Self Sampler. Women randomized to this intervention arm will receive a self-sampling kit via mail. This kit will include: 1) the self-sampler; 2) the vial for collecting and storing the specimen; 3) a pre-addressed, stamped envelope for returning the vial; 4) a brief introductory letter/postcard which includes a picture of the CHE and the CHW and serves to re-orient the participant to the focus of the study; 5) instructional guide that visually depicts the steps for self-sampling;
16094734|NCT02202096|Other|Patient education: One-on-one visit|The navigator or surgeon will have a one-on-one visit with he patient to answer any questions.
16094735|NCT02202096|Other|Discharge planning: Assessment of barriers to discharge|Case management will be consulted on the day of surgery. The navigator will perform an assessment of barriers to discharge based on one-on-one interviews with the patient.
16094736|NCT02202096|Other|Medication reconciliation: Patient medication review|The navigator will review the patient's medications with him/her prior to discharge.
16094737|NCT02202096|Other|Appointment before discharge: Additional measure to ensure awareness of next clinic visit|Additional measures to ensure that patients are aware of the date, time, and place of their clinic visit(s) may include a phone calls or text messages to patients and their caregivers by the navigator, surgeon or clinic nurse.
16094738|NCT02202096|Other|Transition coach|The navigator will assist with coordination of care and tracking follow-up appointments and tests.
16094739|NCT02202096|Other|Patient-centered discharge instructions: Enhanced|Enhanced, language-specific, discharge instructions will be developed and provided to all patients verbally and in a written format designed for patients with limited literacy skills.
16094740|NCT02202096|Other|Provider continuity: Specific surgeons responsible for coordinating care with medical/radiation oncology|"Drs. Stefanos Millas (colorectal surgery) and Curtis Wray (surgical oncology) will be responsible for coordinating care with medical and radiation oncology as well as consulting when patients are readmitted to the hospital (if not admitted to the surgical service). Changes will be made to the clinic scheduling process for colorectal cancer surgery patients to minimize wait times, to allow them to be seen on a walk-in basis, and to prioritize visits for patients with urgent problems as identified by follow-up calls or inquiries to the Ask My Nurse hotline."
16094741|NCT02202096|Other|Timely follow-up: Barriers to clinic follow-up visits will be discussed|Patients will be queried about financial barriers to clinic follow-up such as lack of money for parking and/or lack of transportation; parking vouchers and taxi/bus vouchers may be provided.
16094742|NCT02202096|Other|Timely PCP communication|The operating surgeon will phone the PCP prior to and upon discharge to discuss concerns and follow-up care plans. Communication via the electronic medical record (EPIC) will also be sent. If the patient does not have a PCP, a referral will be made prior at the initial clinic visit and one provided.
16094743|NCT02202096|Other|Follow-up telephone call|Patients will be contacted by phone by the navigator or surgeon on post-discharge day 1 to identify and address any concerns. If there are concerns, calls may be made on subsequent post-operative days.
16094744|NCT02202096|Other|Patient hotline: 24 hour follow-up following call to Ask My Nurse number|Follow-up will occur within 24 hours of calling the Ask My Nurse number. Patients with emergent problems will be seen immediately by the surgical oncology team if available or the on call surgery team. Patients with non-urgent matters will be called by a member of the surgical oncology team. Arrangements will be made to see the patient in clinic or the ER within the next 8-16 hours depending upon severity and time of day.
16094745|NCT02202083|Other|Cook Balloon|"There are two groups. Acoording to the bishop score, one group uses the oxytocin , and the other uses the cook balloon.
~This group is term gestaion,with bishop score less than 6."
16094746|NCT02202070|Drug|onabotulinumtoxinA|
16094747|NCT02202057|Other|Respiratory resistive load on inhalation|"The participant will be seated in a chair, and will be instructed to relax and breathe through a facemask. Five respiratory resistive loads (5-40 cmH2O resistive pressure) will be applied between 3-5 times during inhalation. Following each loaded breath, participants will rate the perceived difficulty of breathing in."
16094829|NCT02201394|Drug|Ticagrelor loading dose|Single loading dose of Ticagrelor 180 mg
16094830|NCT02201394|Drug|Aspirin loading dose|Single loading dose of Aspirin 325 mg
16094831|NCT02201394|Drug|Ticagrelor maintenance dose|Ticagrelor 90 mg twice daily x 7 days
16094832|NCT02201394|Drug|Aspirin maintenance dose|Aspirin 81 mg once daily x 7 days
16094748|NCT02202057|Other|Fluoroscopic swallowing evaluation|Participants with PD only will receive a swallowing evaluation as part of their routine clinical care. Generally, the standard clinical evaluation protocol consists of multiple swallows of thin liquid barium, pudding-thick barium, and a cracker or cookie coated with barium. Results are reviewed by the treatment speech-language pathologist, and for the purposes of this study, the researchers will review the most recently recorded swallow study and identify the worst observed penetration-aspiration (PA) score.
16094749|NCT02202044|Device|Intravesical BCG and EMDA/MMC|Patients are assigned one course of treatment per week for 6 weeks with sequential 'Intravesical instillation of sequential Bacillus Calmette-Guérin (BCG) and Electromotive Drug Administration /Mitomycin-C
16094750|NCT02202031|Behavioral|Paced Respiration|Participants will use a small, commercially-available guided-breathing device to practice breathing at a rate slower than 10 breaths per minute. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.
16094751|NCT02202031|Behavioral|Music Therapy|Participants will use an identical appearing device, programmed to play quiet, relaxing music, while monitoring spontaneous breathing. Participants will be instructed to use their devices for at least 15 minutes per day for 12 weeks.
16094752|NCT02202018|Other|Active KT intervention|"Provider & patient-directed infographics educating patients about home dialysis will be displayed in prominent clinic wall space
~Educational white board presentations promoting home dialysis
~Each clinic will receive reports outlining their current use of home dialysis in incident ESRD patients compared with provincial & national averages
~A Canadian version of the MATCH D tool will be provided to clinic staff, to help evaluate patient appropriateness for home dialysis.
~Each clinic will receive an in-person visit from one of the study investigators/collaborators detailing the benefits of home dialysis, and the educational tools being offered to support care within their clinic."
16094753|NCT02202005|Drug|Nevirapine|Nevirapine 400mg PR tablet
16094754|NCT02202005|Drug|Viramune®|Viramune® 400 mg Retardtabletten
16094755|NCT02201992|Other|Clinical Observation|Undergo observation
16094756|NCT02201992|Drug|Crizotinib|Given PO
16094757|NCT02201992|Other|Laboratory Biomarker Analysis|Correlative studies
16094758|NCT02201979|Procedure|Vertical breast lift with implants|
16094759|NCT02201953|Drug|SOF/VEL|400/100 mg FDC tablet administered orally once daily
16094760|NCT02201953|Drug|SOF|400 mg tablet administered orally once daily
16094761|NCT02201953|Drug|RBV|Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16094762|NCT02201940|Drug|SOF/VEL|400/100 mg FDC tablet administered orally once daily
16094763|NCT02201940|Drug|Placebo|Tablet administered orally once daily
16094764|NCT02201927|Device|galvanic vestibular stimulation|
16094765|NCT02201914|Drug|Clomiphene citrate|patients receive clomiphene citrate 100 mg daily starting on day 2 for 5 days and 450 IU recombinant FSH and 225 IU recombinant LH daily starting on day 5; Cetrorelix 0,25 mg was administered daily when one or more follicle reached 13-14 mm in diameter until the hCG injection
16094766|NCT02201914|Drug|Daily FSH and LH plus Cetrorelix|Women receive an initial daily dose of 450 IU recombinant FSH and 225 IU recombinant LH starting on day 3; Cetrorelix 0,25 mg was administered daily when one or more follicle reached 13-14 mm in diameter until the hCG injection.
16094767|NCT02201914|Drug|Triptorelin plus daily FSH anh LH|women receive short-acting Triptorelin 0,05 mg daily starting on day 1 until the hCG injection and 450 IU recombinant FSH and 225 IU recombinant LH daily starting on day 2.
16094768|NCT02201901|Drug|SOF/VEL|400/100 mg tablets administered orally once daily
16094769|NCT02201901|Drug|RBV|Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16094770|NCT02201888|Behavioral|Computer-assisted cognitive training|Treatment lasted six months. The CRT and CC conditions consisted of biweekly sessions of 45 minutes. Patients in both conditions trained in groups of up to 8, supervised by a single person. The CRT and CC groups were scheduled at different times. The same personnel supervised both treatment conditions. All supervisors were trained by the coordinator of the study in the technical management of the two conditions.
16094771|NCT02201888|Other|Computerized active condition|Treatment lasted six months. The CRT and CC conditions consisted of biweekly sessions of 45 minutes. Patients in both conditions trained in groups of up to 8, supervised by a single person. The CRT and CC groups were scheduled at different times. The same personnel supervised both treatment conditions. All supervisors were trained by the coordinator of the study in the technical management of the two conditions.
16094772|NCT02201888|Other|Treatment as usual (TAU)|TAU: Patients in this condition participated in their (individually variable) daily rehabilitative activities. Patients allocated to the other two conditions also participated in these activities.
16094773|NCT02201849|Drug|Study Drug|
16094774|NCT02201849|Drug|Active Control|
16094775|NCT02201849|Drug|Placebo|
16094776|NCT02201836|Other|One time music therapy|
16094777|NCT02201836|Other|Group music therapy|
16094778|NCT02201823|Drug|ABTL0812|ABTL0812. Five cohorts and one extension phase.
16094779|NCT02201810|Behavioral|Rate reduction intervention|
16094780|NCT02201810|Behavioral|Recycling Group|
16094781|NCT02201810|Behavioral|Choice Group|
16094782|NCT02201810|Behavioral|Proactive QL|
16094783|NCT02201797|Other|DCE MRI|
16094784|NCT02201784|Drug|Levobupivacaine|Comparison of Equipotent doses
16094785|NCT02201784|Drug|Ropivacaine|Comparison of equipotent doses
16094786|NCT02201771|Drug|Aspirin|
16094787|NCT02201771|Drug|Ticagrelor|
16094788|NCT02201758|Dietary Supplement|Flaxseed lignan-enriched complex (FLC)|Subjects will undergo treatment with FLC for an 8-week period; participants will take 300 mg flaxseed lignan-enriched complex (FLC) taken orally twice daily
16094789|NCT02201758|Other|Placebo|Placebo will consist of unflavored whey protein (manufactured by Natural Factors®)
16094833|NCT02201381|Drug|Metabolic treatment|While subjects are being treated with the four metabolic drugs, every 3 months they will bring in their medical records and data will be collected to determine the effect of the intervention
16094885|NCT02200991|Drug|Sitagliptin|Pharmaceutical form:tablet Route of administration: oral
16094790|NCT02201732|Procedure|Hysteroscopy|Performed under general or local anesthesia, antibioprophylaxis in accordance to center practices may be administered. Cervical dilatation, will be made in order to introduce the hysteroscope. Operative hysteroscope used will include a handle. The distension of the uterine cavity will be performed with physiological saline or glycocoll, depending on the polarity of the high frequency generator necessary for resection system (monopolar or bipolar), with a pressure of maximum irrigation of 110 mm Hg.
16094791|NCT02201732|Procedure|Curettage|Performed under general or local anesthesia, the used material may be rigid or flexible vacurette. In the same way, the prophylactic antibiotic, the diameter of the used vacurette, the importance of cervical dilation necessary and a possible peroperative ultrasound guidance will be left at the discretion of the operator and habits of the center. A check of the uterine vacuity by foam curette will be conducted at the end of curettage.
16094792|NCT02201706|Procedure|Multi-electrocoagulation retinectomy|"a modified surgery named multi-electrocoagulation retinectomy to re-attach the retina.
~All the single surgical technique and devices involved in this modified surgery are used commonly in clinic.
~Base on this, the investigator changes the traditional sequence of these single surgical techniques, and combine them into a new surgical process."
16094793|NCT02201693|Dietary Supplement|MODULEN IBD|2 week ON / 6 weeks OFF treatment every 8 weeks covering at least 100% of daily caloric requirement (approx. 2-2.5L/day).
16094794|NCT02201693|Dietary Supplement|MODULEN IBD|25% of daily caloric requirements, approx. 500mL/day
16094795|NCT02201667|Drug|Ticagrelor|180-mg loading dose followed by 90mg twice daily for 30 days
16094796|NCT02201667|Drug|clopidogrel|300-mg loading dose followed by 75mg once daily for 30 days.
16094797|NCT02201667|Drug|Aspirin|300mg loading dose aspirin and followed by 100mg once daily
16094798|NCT02201667|Procedure|PCI|PCI is performed according to indication for early PCI according to 2012 Chinese NSTE-ACS guideline recommendation
16094799|NCT02201654|Other|EBUS without stylet|the patient will receive both conventional ebus with the stylet and experimental ebus (without the stylet). The two techniques will then be compared to each other on a per lymph node basis.
16094800|NCT02201641|Radiation|Cone Beam computed tomography (Morita Accuitomo)|CBCT scans are taken to assess the efficacy of this method in detecting the presence of early peri-radicular lesions.
16094801|NCT02201641|Radiation|Periapical radiographs|Periapical radiographs are taken as a control to detect the presence of early peri-radicular lesions.
16094802|NCT02201641|Device|calcium silicate cement (Biodentine™)|calcium silicate cement (Biodentine™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulps.
16094803|NCT02201641|Device|glass ionomer cement ( Fuji IX™)|glass ionomer cement ( Fuji IX™) used for indirect pulp capping of teeth with deep carious lesions and inflammed pulp.
16094804|NCT02201628|Device|Nasopharyngeal and oesophageal temperature probes|
16094805|NCT02201615|Other|Perineal massage in childbirth|
16094806|NCT02201602|Drug|Gliclazide|
16094807|NCT02201602|Drug|Glibenclamide|
16094808|NCT02201589|Device|Endovascular repair with Valiant PS-IDE Stent Graft|Endovascular stent graft repair of lesions in the ascending thoracic aorta using the Medtronic Valiant PS-IDE (Physician Sponsored-Investigational Device Exemption) Stent Graft System with the Captivia Delivery System
16094809|NCT02201576|Drug|Bortezomib|"Five plasma exchanges +0.1 g/kg of intravenous immunoglobulins at the end of each course
~two cycles of bortezomib (1.3 mg/m2 IV at day-1, day-4, day-8, day-11) + oral dexamethasone (20 mg po at day-1, day-4, day-8, day-11)
~four courses of polyclonal intravenous immunoglobulins every three weeks (2g/kg, the first two courses are performed simultaneously with the two bortezomib cycles)"
16094810|NCT02201576|Drug|Plasma exchanges and intravenous immunoglobulins|"Five plasma exchanges +0.1 g/kg of intravenous immunoglobulins at the end of each course
~four courses of polyclonal intravenous immunoglobulins every three weeks (2g/kg)
~oral dexamethasone (20 mg po at day-1, day-3, day-5, day-7 of the two first intravenous immunoglobulins courses)"
16094811|NCT02201563|Drug|Minocycline|Oral minocycline (100mg twice a day) for 3 months
16094812|NCT02201537|Device|renal echography|"Renal biopsy will be performed at 3 and 12 months.
~The functional imaging examinations will be held as follows:
~Step 1: the conventional Doppler ultrasound Step 2: ultrasound elastography Step 3: CEUS"
16094813|NCT02201524|Drug|PF-04965842|Subjects will receive 200 mg PF 04965842 twice daily for 4 weeks
16094814|NCT02201524|Drug|PF-04965842|Subjects will receive 400 mg PF 04965842 daily for 4 weeks
16094815|NCT02201524|Drug|PF-04965842|Subjects will receive 200 mg PF 04965842 daily for 4 weeks
16094816|NCT02201524|Other|Placebo|Subjects will receive placebo for 4 weeks
16094817|NCT02201511|Drug|3 mg PF-06412562 MR tablets_Fasted|A single modified release tablet with 3 mg PF-06412562 administered after an overnight fast
16094818|NCT02201511|Drug|2 x 15 mg PF-06412562 MR tablets_Fasted|Two 15 mg PF-06412562 modified release tablets administered after an overnight fast
16094819|NCT02201511|Drug|2 x 15 mg PF-06412562 MR tablets_Fed|Two 15 mg PF-06412562 modified release tablets administered after a high fat breakfast
16094820|NCT02201511|Drug|10 mg PF-06412562 IR tablets|a single immediate release tablet of 10 mg PF-06412562 after an overnight fast
16094821|NCT02201498|Procedure|Pulpotomies with Formocresol/OZE and Biodentine|
16094822|NCT02201485|Device|Stent|
16094823|NCT02201485|Device|Balloon|
16094824|NCT02201472|Device|MRI with MRE|Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device
16094825|NCT02201459|Drug|Nilotinib (Tasigna ®), capsules of 150 mg|Nilotinib 2 capsules of 150 mg orally twice daily at 12 hours difference, fasting (minimum 1 hour before or 2 hours after a meal) for at least 36 months
16094826|NCT02201459|Drug|Nilotinib (Tasigna ®) and Pegylated interferon alfa 2a (Pegasys®)|"Nilotinib 2 capsules of 150 mg orally twice daily at 12 hours difference, fasting (minimum 1 hour before or 2 hours after a meal) for at least 36 months and
~Pegylated interferon alfa 2a subcutaneously once a week (auto-injection syringes of 135 and 90 micrograms) at 30 micrograms/week the first month alone (= priming procedure), then at 30 micrograms/2weeks the first month of combination to nilotinib and then at 45 micrograms/week thereafter until month 24 after nilotinib initiation."
16094827|NCT02201420|Drug|Tc 99m tilmanocept|
16094828|NCT02201407|Drug|Peginterferon alfa-2a|Peginterferon alfa-2a treatment according to standard of care, current summary of product characteristics and in line with the local labeling.
16094834|NCT02201368|Drug|Triheptanoin (SpezialölÒ 107®)|"Randomization: Treatment with Triheptanoin for 6 months
~Washout Period: Treatment with MCT(Medium-Chain Triglycerides)for 2 months
~Crossover: Treatment with MCT(Medium-Chain Triglycerides)for 6 months"
16094835|NCT02201368|Dietary Supplement|MCT (Medium-Chain Triglycerides)|"Randomization: Treatment with MCT(Medium-Chain Triglycerides)for 6 months
~Washout Period: Treatment with MCT(Medium-Chain Triglycerides)for 2 months
~Crossover: Treatment with Triheptanoin for 6 months"
16094836|NCT02201355|Radiation|Intensity Modulated Radiotherapy|Patients treated five fractions per week with radiotherapy dose per fraction and cisplatin dose increased according to the treatment table
16094837|NCT02201342|Drug|Udenafil|Drug
16094838|NCT02201329|Drug|Azacitidine|Azacitidine (subcutaneous)
16094839|NCT02201329|Drug|Volasertib|Volasertib escalating doses (intravenous)
16094840|NCT02201316|Drug|Reference mosapride citrate (GASMOTIN)|Reference mosapride citrate (GASMOTIN) 5mg will be supplied as caplet shaped tablet embossed with P218 and film-coated; administer orally with approximately 240 mL of water.
16094841|NCT02201316|Drug|GR107719B (Formulation 1)|GR107719B (Formulation 1) 5 mg will be supplied as L-HPC disintegrant caplet shaped tablet, embossed and film-coated; administer orally with approximately 240 mL of water.
16094842|NCT02201316|Drug|GR107719B (Formulation 2)|GR107719B (Formulation 2) 5 mg will be supplied as caplet shaped tablet, embossed and film-coated; administer orally with approximately 240 mL of water.
16094843|NCT02201303|Drug|Danirixin|Powdered form for in-vitro administration to blood sample
16094844|NCT02201303|Other|CXCL1|Escalating concentrations of CXCL1 will be added to whole blood in vitro. A CXCL1/CD11b upregulation concentration response curve will determine the concentration to be used in Part 2.
16094845|NCT02201290|Drug|Eltrombopag Tablets|Eltrombopag tablets will be white, round film coated tablets containing eltrombopag olamine equivalent to 12.5 mg, 25 mg, 50 mg and 75 mg of eltrombopag. The 12.5 mg tablet will be smaller than the 25 mg, 50 mg and 75 mg tablets. Subjects will receive maximum dose of 75 mg once daily (QD).
16094846|NCT02201290|Drug|Eltrombopag PfOS|Eltrombopag PfOS is a reddish-brown to yellow powder contained inside an elongated sachet. Each sachet will contain eltrombopag olamine equivalent to 20 mg of eltrombopag per gram of powder. Subjects will receive maximum dose of 75 mg once daily (QD)
16094847|NCT02201277|Device|Filter Placed|
16094848|NCT02201251|Drug|Topiramate|Topiramate weight based dosing for participants 2 to <10 years of age not to exceed 350 mg/day, as tolerated; not to exceed 400 mg/day in participants 10-15 years of age, as tolerated.
16094849|NCT02201251|Drug|Levetiracetam|Levetiracetam weight based dosing for all participants 2-15 years of age, not to exceed 60 mg/kg/day, as tolerated. The maximum recommended daily dosage is 3,000 mg.
16094850|NCT02201238|Drug|Diclofenac sodium|Diclofenac sodium
16094851|NCT02201238|Drug|Menthol|Menthol
16094852|NCT02201225|Dietary Supplement|Nutritional supplement with micronutrient|Nutritional supplement powder with micronutrients packed as 27 g individual sachet, administered orally as a single serve
16094853|NCT02201225|Dietary Supplement|Nutritional supplement without micronutrient|Nutritional supplement powder without micronutrients packed as 27 g individual sachet, administered orally as a single serve
16094854|NCT02201212|Drug|Everolimus|
16094855|NCT02201199|Drug|insulin glargine U200 HOE901|Pharmaceutical form:solution for injection Route of administration: subcutaneous
16094856|NCT02201199|Drug|insulin glargine U500 HOE901|Pharmaceutical form:solution for injection Route of administration: subcutaneous
16094857|NCT02201199|Drug|insulin glargine U100 HOE901|Pharmaceutical form:solution for injection Route of administration: subcutaneous
16094858|NCT02201186|Other|Manuka honey enema|Study patients diagnosed with acute pouchitis will perform manuka honey enemas twice a day for 30 days.
16094859|NCT02201173|Behavioral|Locomotor Training|Progressive retraining in functional skills including balance, transfers, activities of daily living and ambulation. Compliance to eliminate or minimize lower limb orthotics is also expected to optimize sensory input to the spinal cord and promote optimal recovery. Intensive therapy occurs in all three environments 5 times/ week for 90 minutes
16094860|NCT02201160|Dietary Supplement|omega 3|Two groups from our cohort will be supplemented either with omega-3 PUFA or placebo during 3 months. Each subject will take 4 capsules/d. after 3 months, the subjects under omega-3 will continue for another 3 months and the group under placebo will take omega-3 PUFA during another 3 months.
16094861|NCT02201147|Procedure|Cold biopsy polypectomy|removal of eligible polyps using cold biopsy technique until no polyp was visible by narrow-band imaging endoscopy
16094862|NCT02201147|Procedure|Cold snare polypectomy|removal of eligible polyps using cold snare polypectomy technique
16094863|NCT02201147|Device|Cold snare polypectomy|mini (10 mm open diameter) size electrosurgical snare without application of electrocautery
16094864|NCT02201147|Device|Cold biopsy polypectomy|standard- capacity forceps with narrow band imaging endoscopy
16094865|NCT02201134|Drug|sevoflurane|
16094866|NCT02201121|Other|Influences of phenylephrine, dopamine and ephedrine on stroke volume variation and pulse pressure variation|This research mainly study the effect of clinical commonly used vasoconstrictor drugs on blood pressure of pressure
16094869|NCT02201095|Device|Forced air warming|
16094870|NCT02201095|Device|Conduction warming mattress|
16094871|NCT02201082|Procedure|Airway clearance technique|
16094872|NCT02201082|Drug|Amikacin nebulization|
16094873|NCT02201069|Behavioral|health coaching|
16094874|NCT02201056|Drug|TAK-935|TAK-935 oral solution
16094875|NCT02201056|Drug|Placebo|TAK-935 placebo-matching oral solution
16094876|NCT02201043|Drug|Thalidomide 150mg|
16094877|NCT02201043|Drug|Thalidomide 100mg|
16094878|NCT02201043|Drug|Placebo|
16094879|NCT02201030|Biological|NBP606|A single intramuscular injection into the thigh
16094880|NCT02201030|Biological|Prevnar13|A single intramuscular injection into the thigh
16094881|NCT02201004|Drug|TOFOGLIFLOZIN CSG452|Pharmaceutical form:tablet Route of administration: oral
16094882|NCT02201004|Drug|insulin|Pharmaceutical form:solution Route of administration: subcutaneous
16094886|NCT02200991|Drug|Insulin glargine HOE901|Pharmaceutical form:solution Route of administration: subcutaneous
16094887|NCT02200978|Drug|ATO|Given IV
16094888|NCT02200978|Drug|RIF|Given orally
16094889|NCT02200978|Drug|ATRA|Given orally
16094890|NCT02200978|Drug|mitoxantrone|Given IV
16094891|NCT02200978|Drug|Ara-C|Given IV
16094892|NCT02200978|Drug|MTX|Given orally
16094893|NCT02200978|Drug|6MP|Given orally
16094894|NCT02200978|Other|intrathecal injection|Ara-C and dexamethasone
16094895|NCT02200965|Other|My Diabetes, My Information, My Plan Document|A structured, understandable, well designed, user friendly, user developed and approved letter has been developed and undergone user acceptability testing for this purpose. It succinctly contains all information mapping to core diabetes care processes, is simple and easy to digest and effective in encouraging self-understanding and prompting self-care and empowering informative engagement with services and care providers. The satisfaction of users with the communicating letter both in a developmental pilot phase has been assessed by user group feedback and patient questionnaire.
16094896|NCT02200952|Drug|recombinant LH|recombinant LH twice/day for 10 days from pick up
16094897|NCT02200939|Device|Bioinductive implant|
16094898|NCT02200939|Device|Surgical repair|Surgical repair with commercially-available sutures/suture anchors.
16094899|NCT02200926|Other|Loaded breathing training|7 days/weeks, for 8 weeks
16094900|NCT02200926|Other|Unloaded breathing training|7 days/week, for 8 weeks
16094901|NCT02200926|Other|Placebo|7 days/week, for 8 weeks
16094902|NCT02200913|Other|core stabilization exercise|core stabilization exercise, 2 times/week, 10 weeks
16094903|NCT02200913|Other|general trunk strengthening exercise|general trunk strengthening exercise, 2 times/week, 10 weeks
16094904|NCT02200900|Other|Pharyngeal pressure|Babies will have pharyngeal pressures measured during the CPAP and HFNC respiratory support.
16094905|NCT02200900|Other|Transcutaneous carbon dioxide|Babies will have transcutaneous carbon dioxide measured during CPAP and HFNC respiratory support.
16094906|NCT02200900|Other|Pharyngeal gas concentrations|Measurement of pharyngeal oxygen and carbon dioxide concentration will be done during CPAP and HFNC respiratory support.
16094907|NCT02200900|Other|Tidal volume|Tidal breathing indices including tidal volume and FRC base line changes will be recorded during CPAP and HFNC respiratory support.
16094908|NCT02200848|Drug|Lenalidomide, Ibrutinib, Rituximab|Dose level -2 Ibrutinib 280 mg; Lenalidomide 2.5 mg; Rituximab 375 mg/m2 Level -1 Ibrutinib 420 mg; Lenalidomide 2.5 mg; Rituximab 375 mg/m2 Level 1 Ibrutinib 420 mg; Lenalidomide 5 mg; Rituximab 375 mg/m2 Level 2 Ibrutinib 420 mg; Lenalidomide 10 mg; Rituximab 375 mg/m2 Level 3 Ibrutinib 420 mg; Lenalidomide 15 mg; Rituximab 375 mg/m2
16094909|NCT02200822|Drug|beta blockers|
16094910|NCT02200822|Drug|RAAS blockers|RAAS blockers (combination of ACE-I/ARB and a mineralocorticoid receptor antagonist)
16094911|NCT02200809|Device|MR-guided focal laser ablation|
16094912|NCT02200796|Other|Control Meal|High carbohydrate meal
16094913|NCT02200796|Other|Low Protein Meal|Omelet with 15 g of protein
16094914|NCT02200796|Other|Moderate Protein Meal|Omelet with 30 g of protein
16094915|NCT02200796|Other|High Protein Meal|Omelet with 45 g of protein
16094916|NCT02200783|Device|TripTable|Details of the device previously described, designed to medical operator radioprotection. No changes in radial technique beyond the use of the supportive device will be performed.
16094917|NCT02200783|Device|Radial|Standard radial artery catheterization procedure, performed for the purpose of coronary angiography and ad hoc angioplasty if necessary.
16094918|NCT02200783|Device|Femoral|Standard femoral artery catheterization procedure, performed for the purpose of coronary angiography and ad hoc angioplasty if necessary. The supporting device will be the patient's own body, placing the material above the legs.
16094919|NCT02200770|Drug|Inebilizumab|Participants will receive IV inebilizumab 300 mg.
16094920|NCT02200770|Other|Placebo|Participants will receive IV placebo matched to inebilizumab.
16094921|NCT02200757|Drug|Aldoxorubicin|230 mg/m2 (170 mg/m2 doxorubicin equivalent) intravenously on Day 1 of each 21-day cycle. Number of cycles: until tumor progression or unacceptable toxicity occurs.
16094922|NCT02200757|Drug|Topotecan|1.5 mg/m2/day intravenously for 5 consecutive days on Day 1 of each 21-day cycle OR 4 mg/m2 intravenously on Days 1, 8 and 15 of each 28-day cycle. Number of cycles: until tumor progression or unacceptable toxicity occurs
16094923|NCT02200731|Behavioral|FAMOS: psychosocial family intervention|The FAMOS intervention consists of a six session manualized psychosocial intervention including videos and tools. Four sessions focus on the parents and two sessions focus on the childhood cancer survivor and its siblings. The intervention is conducted by a psychologist with Cognitive Behavioral Therapy experience
16094924|NCT02200718|Biological|NeuroVax|NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA BV5S2, BV6S5 BV13S1
16094925|NCT02200718|Biological|IFA Incomplete Freund's Adjuvant|IFA Incomplete Freund's Adjuvant is a vaccine adjuvant composed of a light mineral oil and a surfactant system designed to make a water-in-oil emulsion
16094926|NCT02200705|Device|Ice-Sense3TM|
16094927|NCT02200653|Drug|High dose of MICARDIS®, once daily|
16094928|NCT02200653|Drug|Low dose of MICARDIS®, once daily|
16094929|NCT02200653|Drug|Low dose of COZAAR® / LORZAAR®, once daily|
16094930|NCT02200653|Drug|High dose of COZAAR® / LORZAAR®, once daily|
16094931|NCT02200653|Drug|Placebo|
16094932|NCT02200640|Drug|High dose of Micardis®, once daily|
16094933|NCT02200640|Drug|Low dose of Micardis®, once daily|
16094934|NCT02200640|Drug|Low dose of COZAAR®, once daily|
16094935|NCT02200640|Drug|High dose of COZAAR®, once daily|
16094936|NCT02200640|Drug|Placebo|
16094937|NCT02200614|Drug|Darolutamide (Nubeqa, BAY1841788)|Darolutamide 600 mg (2 tablets of 300 mg) twice daily with food, equivalent to a total daily dose of 1200 mg.
16094938|NCT02200614|Drug|Placebo|Matching placebo 2 tablets twice daily with food.
16094939|NCT02200601|Device|Seipher Wellness|
16094940|NCT02200575|Drug|Telmisartan|
16094941|NCT02200562|Drug|ipilimumab and dabrafenib|
16094942|NCT02200549|Device|Control group|Neither cycle training nor inspiratory muscle training.
16094943|NCT02200549|Device|calibrated cycle ergometer|The most common device to proform cycle training is calibrated cycle ergometer.
16094944|NCT02200549|Device|calibrated cycle ergometer and threshold loading device|Combined cycle training and inspiratory muscle training.The threshold loading device is composed of a mouth -piece attached to a small plastic cylinder that contains a spring-loaded poppet value. The valve opens to permit inspiratory flow only once the person has generated adequate negative intrathoracic pressure to condense the spring.
16094945|NCT02200536|Other|Infant oral health promotion package|Infant oral health promotion package includes an infant oral health pamphlet, a baby toothbrush, fluoride toothpaste (1000 ppm) and a trainer cup.
16094946|NCT02200536|Other|Infant oral health pamphlet|Infant oral health pamphlet
16094947|NCT02200523|Device|SARA electrode|
16094948|NCT02200523|Device|Gold cup|
16094949|NCT02200510|Behavioral|Self-management intervention for Adolescents with SCD|Chronic Disease Self-Management Program
16094950|NCT02200510|Behavioral|Patient Portal Intervention for Adolescents with SCD|MyChart for SCD intervention
16094951|NCT02200484|Behavioral|Combined parent training and obesity prevention program|
16094952|NCT02200484|Behavioral|Wellness program (active contact control)|
16094953|NCT02200471|Device|VeinViewer|
16094954|NCT02200458|Device|VeinViewer|Updated software on the VeinViewer device will be used to project an image of the vasculature on the skin.
16094955|NCT02200445|Drug|Interleukin-2 (aldesleukin).|"Description of intervention is covered in Arm, above."
16094956|NCT02200432|Other|PERSPeCT Recommender System|"PERSPeCT will use data to predict messages that would be most influential to the participant in health behavioral change.
~Patient Experience Recommender System for Persuasive Communication Tailoring. PERSPeCT is an adaptive computer system that will assess a patient's individual perspective, understand the patient's preferences for health messages, and provide personalized, persuasive health communication relevant to the individual patient."
16094957|NCT02200419|Other|POC-based transfusion algorithm|A transfusion algorithm based on point-of-care coagulation testing.
16094958|NCT02200406|Drug|Desvenlafaxine|All subjects will receive 50 mg of the medication during week 1 and 2, then 50-100 mg (based on the psychiatrist judgment) for the following 6 weeks. Subjects who experience significant adverse reactions with the 100mg dose during weeks 2 to 4 could return to the lower dose of 50 mg if judged clinically appropriate by the study psychiatrist.
16094959|NCT02200393|Device|Abdominal FES|"Stimulation intensity was adjusted on a channel by channel basis until a strong visible contraction of the abdominal muscles is observed. During the session, manual adjustment of both the stimulation intensity (to compensate for fatigue) and the duty cycle is possible.
~Four pairs of surface electrodes were placed on the participant's abdomen. One pair will be placed on both the right and left side of the rectus abdominis around the naval. One pair of electrodes will also be placed on both the right and left side of the external oblique muscles with one electrode being placed just below the participant's bottom rib and the other below this with a separation of around 3cm."
16094960|NCT02200380|Drug|CDX-301|Related donors will receive CDX-301 for 5 days or 7 days.
16094961|NCT02200380|Drug|CDX-301 and plerixafor|Related donors will receive CDX-301 for 5 or 7 days plus plerixafor.
16094962|NCT02200367|Behavioral|e-mental health collaborative programme|
16094963|NCT02200367|Other|Usual Care|
16094964|NCT02200354|Drug|pemetrexed with bevacizumab|
16094965|NCT02200341|Behavioral|MBCT|
16094966|NCT02200341|Behavioral|PRT-PsyEd|
16094967|NCT02200328|Drug|Metronidazole|Metronidazole tablets 500mg orally or IV , 3 times a day for a maximum of 14 days
16094968|NCT02200328|Drug|Placebo|Placebo(Corn starch pill) orally 3 times a day for a maximum of 14 days
16094969|NCT02200315|Other|No Antimicrobial prophylaxis|Antimicrobial prophylaxis are not administered during an operation
16094970|NCT02200276|Biological|Influenza|
16094971|NCT02200263|Dietary Supplement|Lutein plus Zeaxanthin|dose: two softgels once a day with a meal
16094972|NCT02200263|Dietary Supplement|Placebo|two softgels once-daily with a meal
16094973|NCT02200237|Biological|EV71 with adjuvant aluminium phosphate|Two arms, EV71 with aluminium phosphate
16094974|NCT02200237|Biological|Placebo|Phosphate Buffer Saline with adjuvant aluminium phosphate
16094975|NCT02200224|Other|Rapid Testing|
16094976|NCT02200211|Device|iPad®|Binocular therapy on iPad®
16094977|NCT02200211|Other|Patching 2 hours per day, 7 days per week|
16094978|NCT02200198|Other|Expiratory muscle training|Patient performs training for 30 minutes per day, during 7 consecutive days, using a Threshold with Positive Expiratory Pressure with a load of 30% of maximal expiratory pressure assessed by digital peak respiratory pressure monitor
16094979|NCT02200198|Other|Inspiratory muscle training|Patient performs training for 30 minutes per day, during 7 consecutive days, using a Threshold for Inspiratory Muscle Training with a load of 30% of maximal inspiratory pressure assessed by digital peak respiratory pressure monitor
16094980|NCT02200198|Other|Sham group|Patient performs training for 30 minutes per day, during 7 consecutive days, using a Threshold without load
16094981|NCT02200185|Drug|IV titrated morphine|"Intravenous morphine : 2 mg every 5 minutes by IV root and nebulized placebo:
~SS nebulised : 5 ml SS nebulised over 10 minutes and repeated 3 times"
16094982|NCT02200185|Drug|Low dose nebulised morphine|10 mg morphine in 4 ml Serum Saline(SS) nebulised over 10 minutes and repeated 3 times, and SS IV placebo : 2 ml by IV root every 5 minutes
16094983|NCT02200185|Drug|High dose nebulised morphine|20 mg morphine in 3 ml serum saline (SS) nebulised over 10 minutes and repeated 3 times, and SS IV placebo : 2 ml by IV root every 5 minutes
16094984|NCT02200172|Other|Melatonin|Sublingual 3mg non-animal synthetic source melatonin daily at 21.00 hours (±1 hour).
16094985|NCT02200172|Other|Placebo|
16094986|NCT02200159|Drug|Sedation with dexmedetomidine|
16094987|NCT02200146|Drug|Prednisone|Prednisone per os 0,5 mg/kg/die once/day for 3 months. After 3 months, between responders, prednisone was slowly tapered (5 mg/week maintaining the new reduced dose for one week) to 0,2 mg/kg/die for further 6 months.
16094988|NCT02200146|Drug|Hydroxychloroquine + Prednisone|Hydroxychloroquine per os 200 mg/die (or adjusted for body weight if less than 61 kg), twice/day + prednisone 0,15 mg/kg per os daily, once/day for 3 months, than for further 6 months between responders.
16094989|NCT02200133|Other|Individualized Survivorship Care Plan (SCP)|The individualized SCP incorporates patient specific treatment exposures and provides a framework for long term followup based on those exposures and subsequent risks for late complications.
16094990|NCT02200107|Behavioral|self management education|
16094991|NCT02200094|Drug|Low dose of Telmisartan, once daily|
16094992|NCT02200094|Drug|High dose of Telmisartan, once daily|
16094993|NCT02200081|Drug|MGN1703|
16094994|NCT02200081|Other|Standard of care|Usual Standard of Care according to local investigators practise, e.g. Treatment break continous treatment and other
16094995|NCT02200068|Other|SANOIA Website|
16094996|NCT02200055|Device|Bodystat Quadscan 4000|"Each patient involved in the study will be evaluated with a bioimpedance monitor to assess total body water, estimated body water, and intravascular body water volume preoperatively, postoperatively, and daily during the postoperative recovery period.
~Bioimpedance Assessment"
16094997|NCT02200042|Radiation|Image Guided Radiation Therapy|Patients undergo 15 fractions of image-guided radiation therapy delivered over 19-26 or 27-34 days.
16094998|NCT02200029|Drug|Ademetionine IV+tablet|IV ademetionine (500 mg/vial) for 2 weeks followed by oral ademetionine (500 mg/tablet, 2 in the morning and 1 before dinner) for 6 weeks
16094999|NCT02200029|Drug|Ademetionine tablet|oral ademetionine (500 mg/tablet, 2 in the morning and 1 before dinner) for 8 weeks
16095000|NCT02200016|Procedure|Ultrasound guided short axis (SAX) placement of sciatic nerve catheters|Sonosite EDGE ultrasound scanner guided insertion of a B Braun Contiplex S catheter along the short axis of the sciatic nerve behind the knee.
16095001|NCT02200016|Procedure|Ultrasound guided long axis (LAX) placement of sciatic nerve catheters|Sonosite EDGE ultrasound scanner guided insertion of a B Braun Contiplex S catheter along the long axis of the sciatic nerve behind the knee.
16095002|NCT02200016|Device|B Braun Contiplex S catheter|
16095003|NCT02200003|Behavioral|attention bias modification for anxiety|
16095004|NCT02199977|Other|Free Malaria Rapid Diagnostic Test|Malaria RDT is offered free if patients choose to be tested
16095005|NCT02199977|Other|Conditional ACT voucher|"Participants will be eligible to receive a drug subsidy for a set amount (in the form of a voucher) conditional on a positive malaria test. When a conditional subsidy is offered, it is valid for use on a Green Leaf approved malaria drug."
16095006|NCT02199977|Other|Malaria Rapid Diagnostic test for a charge|Participants can receive a malaria RDT for a set amount (i.e., not for free).
16095007|NCT02199964|Drug|Cyclosporin 0.05% emulsion|Topical therapy for dry eye
16095008|NCT02199964|Drug|Endura, Refresh artificial tears|Over the counter therapy for dry eye, used 4 times a day
16095009|NCT02199951|Drug|Dihydroartemisinin and piperaquine|Antimalarial
16095010|NCT02199938|Other|Identification and characterization of molecular markers in musculoskeletal tumors|
16095011|NCT02199925|Drug|Gammaplex 5%|
16095012|NCT02199912|Procedure|Biopsy of adipose and muscular tissue|
16095013|NCT02199912|Other|Blood sampling|
16095014|NCT02199912|Other|Calorimetry|
16095015|NCT02199912|Other|Impedance measure|Evaluation of physical composition (non-invasive method)
16095016|NCT02199912|Other|Evaluation of nutritional status|"Nutritional status will be assessed by using the Mini Nutritional Assessment (MNA) questionnaire and a scale that evaluates anorexia"
16095017|NCT02199912|Other|Evaluation of physical performance|"This will be assessed by using a tiredness scale named Echelle Visuelle Analogique (EVA) in french"
16095018|NCT02199912|Other|Evaluation of muscular strength|Muscular strength will be assessed thanks to the Handgrip Strength Test and the Short Physical Performance Battery (SPPB)
16095019|NCT02199912|Other|Evaluation of emotional status|The emotional status wil be assessed thanks to the Yesavage Geriatric Depression Scale (GDS)
16095020|NCT02199912|Other|Evaluation of functional status|The functional status will be assessed by using the Activity of Daily Life (ADL) questionnaire and the Instrumental Activities of Daily Living (IADL) Questionnaire
16095021|NCT02199899|Drug|BIIF 1149 BS - single rising doses|
16095022|NCT02199899|Drug|Placebo|
16095023|NCT02199886|Drug|BIBH 1|labeled with eight to ten millicurie of 131I
16095024|NCT02199873|Drug|BIIX 1 XX - single rising dose|
16095025|NCT02199873|Drug|Placebo|
16095026|NCT02199860|Drug|SD I|
16095027|NCT02199860|Drug|SD II|
16095028|NCT02199860|Drug|Placebo|
16095029|NCT02199847|Drug|Pharmaton® Caplets|
16095030|NCT02199847|Drug|Placebo|
16095031|NCT02199834|Behavioral|Peer support|15 patients who have good glycemic control and self-care will be trained as peer supporters to deliver peer support under supervision by a program manager. Peer supporters will call their peers at least 12 times a year to provide both informational and emotional support.
16095032|NCT02199834|Behavioral|Personalized feedback report|Patients will receive a personalized feedback report displaying trends of metabolic control of A1c, BP, LDL-C, and body weight, with automated decision support based on their own attained values every 4 months through mails.
16095033|NCT02199821|Dietary Supplement|Formula with soybean oil, medium-chain triglycerides|
16095034|NCT02199821|Dietary Supplement|Soybean oil formula commonly used in the hospital|
16095035|NCT02199795|Device|Contralaterally Controlled Neuromuscular Electrical Stimulation|
16095036|NCT02199795|Device|Cyclic Neuromuscular Electrical Stimulation|
16095037|NCT02199782|Other|Welsh language Cognitive Assessment|This intervention may intervene by displaying a more realisitic reflection of the patient's cognitive ability by assessing the patient in their first language
16095038|NCT02199769|Other|Clinical Decision Support|Investigators will develop and implement an automated Diabetes Detection Tool (DDT) that does data mining on EMR lab data to systematically identify all primary care patients with elevated RPGs who are at high risk of diabetes and in need of further diabetes testing/screening.
16095039|NCT02199743|Drug|Lurasidone|Compare to haloperidol and perphenazine
16095040|NCT02199743|Drug|Haloperidol|Compare to lurasidone
16095041|NCT02199743|Drug|Perphenazine|Compare to lurasidone
16095042|NCT02199717|Device|Accelerometer|
16095160|NCT02198833|Biological|Urine Culture|Obtain urine culture every third day
16095161|NCT02198833|Device|Foley Catheter Tip Culture|Catheter Tip Roll Plate Culture
16095043|NCT02199704|Other|Self Directed Positive Parenting Program|"Individuals with psychosis who are parents will receive a copy of the Every Parent's Self Help Workbook (Markie-Dadds, Sanders & Turner, 1999) and up to ten sessions of support. This is a case series study."
16095044|NCT02199691|Biological|Meningococcal Polysaccharide (Serogroups A, C, Y, and W135) Tetanus Toxoid Conjugate Vaccine|0.5 milliliter (mL), Intramuscular (IM)
16095045|NCT02199691|Biological|Meningococcal (Groups A, C, Y and W135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine|0.5 mL, IM
16095046|NCT02199691|Biological|Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed|0.5 mL, IM
16095047|NCT02199691|Biological|GARDASIL®: Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant|0.5 mL, IM
16095048|NCT02199691|Biological|Meningococcal Polysaccharide (Serogroups A, C, Y, and W135) Tetanus Toxoid Conjugate Vaccine|0.5 mL, Intramuscular (IM)
16095049|NCT02199691|Biological|Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed|0.5 mL, IM
16095050|NCT02199691|Biological|GARDASIL®: Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant|0.5 mL, IM
16095051|NCT02199678|Drug|Placebo|placebo
16095052|NCT02199678|Drug|ketamine 25 mg|ketamine
16095053|NCT02199678|Drug|ketamine 35 mg|ketamine
16095054|NCT02199678|Drug|ketamine 50 mg|ketamine
16095055|NCT02199665|Drug|selinexor|Given PO
16095056|NCT02199665|Drug|carfilzomib|Given IV
16095057|NCT02199665|Drug|dexamethasone|Given PO or IV
16095058|NCT02199652|Drug|Prazosin|
16095059|NCT02199652|Drug|Placebo|
16095060|NCT02199626|Device|Second generation of colon capsule endoscopy (GIVEN IMAGING)|
16095061|NCT02199613|Drug|Treatment simplification|Eligible, consenting subjects will start open-label darunavir 800mg plus the co-formulated tenofovir DF/FTC/cobicistat/elvitegravir (Stribild) tablet once daily with food, following the study procedures at the baseline visit. They will be assessed at weeks 2, 12, 24, 36, and 48 after starting the new regimen.
16095062|NCT02199600|Device|GMK Sphere Knee Replacement|
16095063|NCT02199587|Behavioral|Presence of medical clown during endocrine test|
16095064|NCT02199574|Drug|EXPAREL|133 mg EXPAREL in 10 mL.
16095065|NCT02199561|Biological|Fecal Microbiota Transplant|Fecal transplant processed from routinely screened universal donor
16095066|NCT02199548|Other|Interview|This study involves teen participants taking part in one private interview with the study team. Interviews last less than one hour and are scheduled at the participant's convenience. Interviews will be audio/digital recorded. Participants may answer any or all of the questions.
16095067|NCT02199522|Procedure|titration induction to propofol|propofol intravenously by Fresenius pump at the speed of 1 mg•kg-1•min-1, and OAA/S scale of the patients was titrated to 1
16095068|NCT02199509|Drug|Levetiracetam|Anticonvulsant
16095069|NCT02199496|Biological|Stelara (ustekinumab)|"In the single-phase part of the study, subjects receive a single dose of Stelara (ustekinumab) 270 mg subcutaneously on Day 0 study visit.
~In the multi-phase part of the study, subjects receive single dose of Stelara (ustekinumab) 270 mg subcutaneously on Day 0 study visit with follow up dose of Stelara (ustekinumab) 90 mg subcutaneously at Week 8, Week 16, Week 24, Week 32 and Week 40"
16095070|NCT02199457|Device|SVSS and reference devices|Blood pressure will be measured with standard mercury manometer
16095071|NCT02199457|Device|SVSS and reference devices|Body temperature taken with infrared thermometer
16095072|NCT02199457|Device|SVSS and reference devices|Pulse rate and Sp02 measured with a reference pulse oximter. The pulse oximeter is just clipped to the end of the finger.
16095073|NCT02199457|Device|SVSS and reference devices|Measurement of respiration rate
16095074|NCT02199444|Drug|Sevelamer|The dose of Sev was 2400 mg (800 mg three times a day) in all patients.
16095075|NCT02199444|Drug|Placebo|
16095076|NCT02199431|Drug|Lu AF11167|
16095077|NCT02199431|Drug|Itraconazole|
16095078|NCT02199418|Drug|Paclitaxel|
16095079|NCT02199418|Drug|Cisplatin|
16095080|NCT02199405|Other|Massage of chiropractic and adjusting cervical curvature|Massage of chiropractic and adjusting cervical curvature, 10 minutes, three times one week for 4 weeks
16095081|NCT02199405|Other|Sishi Daoyin|Sishi Daoyin, practicing during 9-11am, once a day for 4 weeks
16095082|NCT02199405|Other|conventional massage|Conventional massage , 15 minutes, three times one week for 4 weeks
16095083|NCT02199405|Other|Cervical traction|
16095084|NCT02199392|Drug|Lenvatinib|subjects will take a single oral dose of 24 mg lenvatinib on three separate occasions (Period 1, Day 1; Period 2, Day 15; and Period 3, Day 43). In Period 2, Day 15, subjects will also take a single oral dose of 600 mg po rifampin. In Period 3, subjects will receive 600 mg rifampin po daily for 21 days (Period 3, Days 29 to 49). On Day 43 of Period 3, subjects will take 24 mg lenvatinib in addition to the rifampin.
16095085|NCT02199379|Drug|Lenvatinib|Lenvatinib will be taken as a single dose of 24 mg consisting of 2 x 10 mg and 1 x 4 mg capsules. Treatment will be administered orally with 240 mL of water following a 10-hour overnight fast.
16095086|NCT02199366|Procedure|Cardiac magnetic resonance (cardiac MRI)|Participants will have a cardiac MRI at baseline and within 1 year after completion of radiation therapy.
16095087|NCT02199353|Other|Stimulation of Activities Daily Living|"Experimental group: SADL programme which is a new treatment approach created by the authors of this study for the training of ADL through cognitive intervention. The programme is based on the reestablishment of the cognitive functions implied in the performance of basic activities of daily living.
~The treatment was carried out twice a week (Tuesday and Thursday) for 45 minutes during 5 weeks."
16095088|NCT02199353|Other|Conventional ADLOccupational Therapy|"Control group treatment: conventional occupational therapy intervention for the management of ADL deficits. The compensation approach was used and environment modifications and simplification of activities were applied as the intervention method.
~The treatment was carried out twice a week (Tuesday and Thursday) for 45 minutes during 5 weeks."
16095089|NCT02199340|Other|iStep exercise test|newly developed submaximal exercise test
16095090|NCT02199340|Other|CPET exercise test|maximal gold standard exercise test
16095162|NCT02198833|Device|Scanning Electron Microscopy|Houston Site Only
16095344|NCT02197234|Procedure|Pharmacokinetic sampling - AZD9291|Blood sampling to measure AZD9291
16095091|NCT02199327|Drug|Mitomycin C|Patients treated with mitomycin will be handled by cycles until resolution of the lesion, which according to previous studies is expected between 3 and 6 cycles (between half months and 3 months).
16095092|NCT02199327|Drug|Interferon Alfa-2b|Patients managed with interferon will be treated for a period ranging from one month to 12 months according to clinical resolution of the lesion. Both groups will be evaluated by at least one year after the resolution of the lesion to determine the presence of recurrences
16095093|NCT02199314|Drug|Desflurane|
16095094|NCT02199301|Procedure|Transplantation Conditioning for BMT|Transplantation Conditioning for BMT (POD#-7~-1) POD#-7: Rituximab (Mabthera, Roche Pharma Aktiengesellschaft (AG) Swiss) 375/m2 iv infusion POD#-6~-3: Fludarabine (Fludara Inj., Bayer AG, Germany) 30mg/m2/day iv infusion POD#-5~-4: Cyclophosphamide (Endoxan Inj., Baxter Oncology Gesellschaft mit beschränkter Haftung (GmbH), Germany) 30mg/kg/day iv infusion POD#-2: (Rituximab 375/m2 iv infusion) POD#-1: Thymic irradiation (Dose, 700cGy)
16095095|NCT02199262|Other|music intervention|reminder+ 20 minutes in the morning and 20 minutes in the afternoon of music listening(classical or soft background music), delivered by compact disc players with headphones with disposable ear pads.
16095096|NCT02199262|Other|reflexology|reminder + 20 minutes per day feet reflexology massage provided by certified specialist in reflexology massages
16095097|NCT02199262|Other|reminder|Implementation of a reminder of guidelines of agitation diagnosis and management
16095098|NCT02199249|Device|Open reduction Tightrope fixation|Device: Following fixation of Weber C fibular fracture according to AO standards, the syndesmosis will be stabilized by open reduction followed by use of a single Tightrope (Arthrex-Knotless) device. Open Reduction Tightrope fixation (OT)
16095099|NCT02199249|Device|open reduction screw fixation|Device: Following fixation of Weber C fibular fracture according to AO standards, the syndesmosis will be stabilized by open reduction followed by use of two or more syndesmosis screws. Open Reduction screw fixation (OS)
16095100|NCT02199236|Radiation|endorectal brachytherapy|Patients will receive 3 fractions of endorectal brachytherapy, each spaced apart by 7 days (+/- 1 day). The three dose tiers will be 1500cGy (500cGy per fraction), 1800cGy (600cGy per fraction), and 2100cGy (700cGy per fraction).
16095101|NCT02199236|Drug|concurrent capecitabine or 5-FU|"Patients will receive 500 mg and 150 mg oral tablets of capecitabine for the prescribed dose of 825 mg/m2 BID, morning and evening (total daily dose of 1650 mg/m2 ). Dosages will be rounded to the nearest 150 mg or 500 mg. Tablets should be swallowed with water within 30 minutes after a meal. Capecitabine will be started on the Monday of the first week of brachytherapy (day 1) and taken on weekdays (Monday through Friday) during weeks of brachytherapy only.
~Administration of 5-FU should be only by the intravenous route taking care to avoid extravasation. Patients will receive 225 mg/m2/day, as a continuous venous infusion by a portable pump for the 3 weeks of treatment. The infusional 5-FU will be exchanged every 7 days."
16095102|NCT02199236|Behavioral|Questionnaires|Patients should complete the 2 quality of life questionnaires during their follow-up appointments. If they are unable to be seen in follow-up, they may complete the questionnaires at home and email or mail them back to the investigator. Should there be any incomplete or ambiguous answers, a follow-up phone call will be made by a member of the research team for clarification. Additionally, if the questionnaires have not been returned within 3 weeks after the time when they are due, a member of the research team will call the patient, and the questions will be completed over the phone.
16095103|NCT02199223|Drug|regorafenib + panitumumab|
16095104|NCT02199210|Other|Prompting forethought|Participants will be asked questions which elicit specific forethought elements related to the given clinical situation. These are elements that relate to strategic planning, goal setting, goal orientation, imagery, outcome expectation. These context specific questions will be determined in the Pilot study and validated in Study I.
16095105|NCT02199197|Drug|Radium Ra 223 Dichloride|Radium Ra 223 Dichloride, 55 kilobecquerel (kBq)/kg body weight, administered as a bolus intravenous (IV) injection (up to 1 minute) on Day 1 of each cycle for 6 cycles.
16095106|NCT02199197|Drug|Enzalutamide|Enzalutamide 160 mg administered orally once a day (continuously) for 6 cycles.
16095107|NCT02199184|Drug|Cyclophosphamide|Given IV
16095108|NCT02199184|Drug|Doxorubicin Hydrochloride|Given IV
16095109|NCT02199184|Drug|Etoposide|Given IV
16095110|NCT02199184|Biological|Ofatumumab|Given IV
16095111|NCT02199184|Drug|Prednisone|Given PO
16095112|NCT02199184|Biological|Rituximab|Given IV
16095113|NCT02199184|Drug|Vincristine Sulfate|Given IV
16095114|NCT02199171|Drug|carboplatin|Given via HIPEC
16095115|NCT02199158|Procedure|Argon Laser Peripheral Iridoplasty|ALPI was applied with a VISULAS diode laser of 532 nm (Carl Zeiss Meditec, Dublin, CA) by the same ophthalmologist (JML). Twenty to 40 spots of 400 mW power with 500 microns of size and duration of 500 ms were applied. Power was modified arbitrarily until an effective iris contraction was obtained. It was considered an effective contraction as that which causes a concentric movement around the laser spot, with minimal iris pigmentation and immediate angle opening observed through the lens mirrors using a Goldmann lens. Power was lowered if there was any bursting sound perceived, pigment dispersion, air bubbles or considerable pain.
16095116|NCT02199145|Procedure|Blood and urine analysis|creatinine, albumin, blood electrolytes, proteinuria / creatinine in sample 1 assay Ac anti-PLA2R1 on 3 ELISA (human, rabbit and mouse)
16095117|NCT02199119|Behavioral|Exercise|30 min of moderate exercise on a treadmill
16095118|NCT02199119|Behavioral|TV viewing|watching TV (animated children's programming) for 30 min
16095119|NCT02199119|Behavioral|Sitting quietly|Sitting quietly for 30 min
16095120|NCT02199106|Device|Left temporal verum cTBS|"Continuous theta burst stimulation (MC-B70, MagPro,MagOption, Medtronic, Germany): 400 triplets of stimuli (triplets with 50Hz) at an frequency of 5Hz (in sum 1200 stimuli) with a break after 200 bursts over the left Heschl's gyrus targeted with anatomical neuronavigation (Localite, Germany); 30% maximum stimulator output (each session)
~Arms: Left temporal verum cTBS"
16095121|NCT02199106|Device|Left temporal placebo cTBS|"Continuous theta burst stimulation (MC-B70, MagPro,MagOption, Medtronic, Germany): 400 triplets of stimuli (triplets with 50Hz) at an frequency of 5Hz (in sum 1200 stimuli) with a break after 200 bursts over the left Heschl's gyrus targeted with anatomical neuronavigation (Localite, Germany); 30% maximum stimulator output (each session); coil tilted by 45° over both wings
~Arms: Left temporal placebo cTBS"
16095635|NCT02195089|Drug|BLS_ILS_E710c 1500mg|- 6 capsules per day for 8 weeks (week 1,2,4 & 8)
16095122|NCT02199093|Other|Functional Rehabilitation of apraxia|"The intervention will cover every type of approaches related with upper limb apraxia.
~We will use different kinds of tools to activate cerebral networks implied on apraxia, for facilitating the cerebral neuroplasticity in the recovering of the patient.
~On the other hand, when the function can not be improved, we will provide skills and strategies for enhance the environment adaptation and increasing the autonomy and independence."
16095123|NCT02199093|Other|Traditional health educative protocol|The traditional health educative protocol consist in an educational workshop for patients and caregivers where they are taught the implications of apraxia in their daily live, kind of errors of apraxia for gaining consciousness of the syndrome, and some strategies to facilitate the adaptation of the patient in her house.
16095124|NCT02199080|Other|D-dimer assay before ablation of atrial fibrillation|Blood sample collection for D-dimers measurement
16095125|NCT02199054|Other|wheat-safflower oil pretzels|Each serving (6 pieces) of the wheat-safflower oil pretzel contains 6 grams of safflower oil. Ingredients in the pretzel are high gluten wheat flour, safflower oil, sugar, yeast, salt, and ascorbic acid.
16095126|NCT02199054|Other|soy-safflower oil pretzels|Each serving (6 pieces) of the soy-safflower oil pretzel contains 6 grams of safflower oil. Ingredients in the pretzel are high gluten wheat flour, soy flour, soymilk, safflower oil, sugar, yeast, salt, and ascorbic acid.
16095127|NCT02199054|Other|control wheat pretzels|Each serving (6 pieces) of the control wheat pretzel contains 6 grams of vegetable shortening. Ingredients in the pretzel are high gluten wheat flour, vegetable shortening, sugar, yeast, salt, and ascorbic acid.
16095128|NCT02199041|Drug|Cyclophosphamide|Given by intravenous infusion as part of the preparative regimen.
16095129|NCT02199041|Drug|Thiotepa|Given by intravenous infusion as part of the preparative regimen.
16095130|NCT02199041|Drug|Fludarabine|Given by intravenous infusion as part of the preparative regimen.
16095131|NCT02199041|Drug|Melphalan|Given by intravenous infusion as part of the preparative regimen.
16095132|NCT02199041|Drug|Mesna|Mesna is generally dosed at approximately 25% of the cyclophosphamide dose. It is generally given intravenously prior to and again at 3, 6 and 9 hours following each dose of cyclophosphamide.
16095133|NCT02199041|Biological|G-CSF|Given either by intravenous infusion or subcutaneously daily until absolute neutrophil count (ANC) >2000 for 3 consecutive days.
16095134|NCT02199041|Drug|Mycophenolate mofetil|Given either orally or by intravenous infusion as part of the post-transplantation immunosuppression.
16095135|NCT02199041|Drug|Tacrolimus|Given either orally or by intravenous infusion as part of the post-transplantation immunosuppression.
16095136|NCT02199041|Drug|Methylprednisolone|Given either intravenously or orally, if needed to treat graft-versus-host-disease (GVHD).
16095137|NCT02199041|Radiation|Total lymphoid irradiation|TLI will be administered in divided fractions given at a minimum of 6 hours apart.
16095138|NCT02199041|Biological|Lymphocyte infusions|Donors will undergo haploidentical mobilization with G-CSF. Cells will be collected by leukapheresis over two days, then processed using the investigational CliniMACS device and CD34 Microbead reagent as directed by the manufacturer.
16095139|NCT02199041|Device|CliniMACS|The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells.
16095140|NCT02199028|Drug|Hyaluronidase|150 units/ml - subjects injected 1 milliliter (ml) into the catheter hub prior to connecting the insulin infusion set on Day 1 and 3 of infusion set wear.
16095141|NCT02199028|Other|Control|No hyaluronidase administered into insulin infusion set.
16095142|NCT02199015|Device|Lateral spinal cord surgical implant of electrodes|"The procedure is based on the classic approaches to posterior cervical region for herniated discs, actually not longer employed for that aim A unilateral hemilaminectomy will be performed at C3-C4 level, starting from 4th cervical spinous process.
~A multicontact electrode will be placed on the lateral surface of the spinal cord that will be subcutaneusly connected to an implanted pulse generator (IPG)."
16095143|NCT02199002|Device|multi-pH-impedance manometry catheter|a special catheter will be placed in the esophagus of all study groups. Measurment of pH, impedance and pressure will be performed.
16095144|NCT02198989|Behavioral|peer support and yoga music therapy|Patients in the intervention group will receive peer support and yoga music therapy before bed.
16095145|NCT02198963|Drug|Hypochlorous acid solution 106 mg/L|test product
16095146|NCT02198963|Drug|0.1% (w/v) Sodium Lauryl Sulfate|positive control
16095147|NCT02198963|Drug|0.9% Physiological Saline, USP|negative control
16095148|NCT02198937|Other|Blood sample|
16095149|NCT02198924|Drug|Parecoxib and Celecoxib|Patients in the study group are supplied sequential treatment with Parecoxib 40 mg intravenously (IV) twice daily (Q12h) for the first 3 days post-surgery followed by Celecoxib 200mg orally twice daily (Q12h) up to 6 weeks post-surgery.
16095150|NCT02198924|Drug|placebo|control patients are supplied with the corresponding placebo with the same instructions.
16095151|NCT02198911|Other|NO GUM|For the NO GUM condition, participants will not chew gum before engaging in a computer task that will allow participants to earn points for MCC ice cream that they can consume.
16095152|NCT02198911|Other|MCC (Mint Chocolate Chip gum)|For the MCC gum condition, participants will chew MCC gum before engaging in a computer task that will allow participants to earn points for MCC ice cream that they can consume.
16095153|NCT02198911|Other|C (Cinnamon gum)|For the C gum condition, participants will chew Cinnamon gum before engaging in a computer task that will allow participants to earn points for MCC ice cream that they can consume.
16095154|NCT02198898|Device|GUARDIX-SG|
16095155|NCT02198872|Other|Exercise, Aerobic (Water based)|Patients of this group will be submitted to an aerobic water based physical training
16095156|NCT02198872|Other|Land Group|Patients of this group perform physical training on bicycle.
16095157|NCT02198859|Drug|Lithium Carbonate|
16095158|NCT02198846|Device|insulin pump|stop any antihyperglycemic medication and convert to insulin pump
16095159|NCT02198846|Drug|conventional treatment|intensification of conventional treatment by adding oral antihyperglycemic agents or subcutaneous insulin (once / twice/ multiple injection)
16095163|NCT02198833|Procedure|Device Specific Adverse Event Assessment|Assessment will be made of catheter patency and/or trauma related to catheter placement
16095164|NCT02198833|Procedure|Foley Catheter Insertion|Insert Foley catheter for 15 day duration
16095165|NCT02198820|Drug|General Anesthesia|General anesthesia with proposal, rocuronium and sufentanil
16095166|NCT02198820|Drug|Loco Regional Anesthesia|Loco Regional Anesthesia with marcaine
16095167|NCT02198807|Drug|Fosmidomycin-Piperaquine|
16095168|NCT02198794|Drug|SD-809|SD-809 will be administered per dose and schedule specified in the arm.
16095169|NCT02198794|Drug|Placebo|Placebo matching to SD-809 will be administered per schedule specified in the arm.
16095170|NCT02198755|Device|Hitachi-Aloka Noblus ultrasound scanner|High resolution ultrasound with the Hitachi-Aloka Noblus Scanner and a 8-15mHz transducer
16095171|NCT02198755|Device|Magnetic Resonance Imaging (MRI)|MRI with or without contrast
16095172|NCT02198742|Device|Miller blade|To participate in the study the subjects must have >500 intubations with the miller blade.
16095173|NCT02198742|Device|Truview PCD|Subjects were given a quick guide of the Truview PCD supplied by the manufacturer with step by step instructions for use. They were also given time to practice with the device on a normal model until they felt comfortable.
16095174|NCT02198742|Device|Glidescope Cobolt|Subjects were required to watch a instructional video provided by the manufacturer. Subjects were then allowed to practice on a normal model until they felt comfortable before beginning the study. There is no placebo group, and each subject wil be his or her own control.
16095175|NCT02198729|Procedure|Endoscopic Submucosal Dissection|
16095176|NCT02198729|Procedure|Endoscopic Mucosal Resection|
16095177|NCT02198716|Procedure|Percutaneous Coronary Intervention using drug eluting stents|Percutaneous Coronary Intervention using drug eluting stents
16095178|NCT02198716|Procedure|Percutaneous Coronary Intervention using bare metal stents|Percutaneous Coronary Intervention using bare metal stents
16095179|NCT02198703|Dietary Supplement|Probiotics bacterial strains|
16095180|NCT02198703|Dietary Supplement|Placebo|
16095181|NCT02198690|Other|Mammography decision aid|
16095182|NCT02198690|Other|Home safety pamphlet|
16095183|NCT02198677|Procedure|Anterior to posterior pressures|Anterior to posterior pressures
16095184|NCT02198677|Procedure|Lateral glide|Lateral glide
16095185|NCT02198664|Biological|AR101 - Peanut protein capsule|characterized peanut allergen provided in break apart capsules for oral immunotherapy
16095186|NCT02198651|Biological|Adalimumab|Pre-filled syringe, administered by subcutaneous injection
16095187|NCT02198651|Other|Placebo|Pre-filled syringe, administered by subcutaneous injection in the Double-blind period
16095188|NCT02198638|Biological|A nasal swab|A nasal swab was performed by a research assistant and influenza virus infection was confirmed by enzyme-linked immunosorbent assay and reverse transcription-polymerase chain reaction on viral cultures
16095189|NCT02198625|Other|Moderate FiO2 and Protective Lung Ventilation Using|
16095190|NCT02198612|Other|Manual puncture point compression|Manual puncture point compression following a diagnostic or therapeutic procedure by endovascular technique involving retrograde femoral puncture point with 5F guide catheter
16095191|NCT02198599|Procedure|Mobility-enhancing-nursing intervention|Patients' mattresses are placed on the floor, which enables the patients to explore their environment safely without the risk of falling. Additionally, the patients' environment is arranged in accordance with a nursing assessment pertaining to the patients' impairment and abilities, their goals in terms of improved mobility, and the mobility they would require in order to live at home as independently as possible. Initially, most patients favour a specific side to get up. The goal of the intervention is to teach the patients to get up step by step and to move independently over both sides.
16095192|NCT02198560|Device|RS-3000 Lite|
16095193|NCT02198547|Drug|Magnesium Sulfate|Mg used with ropivacaine for sciatic nerve blick
16095194|NCT02198547|Drug|Ropivacaine|Ropivacaine 7,5 mg/ml used for sciatic nerve block
16095195|NCT02198534|Device|Methodology of visual acuity assessment|
16095196|NCT02198508|Drug|DFX(Deferasirox)|
16095197|NCT02198508|Drug|DFP(Deferiprone)|
16095198|NCT02198495|Drug|Supplementation of ferric carboxymaltose|
16095199|NCT02198495|Drug|Supplementation of iron sucrose|
16095200|NCT02198482|Drug|Volasertib|
16095201|NCT02198482|Drug|Cytarabine|
16095202|NCT02198482|Drug|Daunorubicin|
16095203|NCT02198482|Drug|Mitoxantrone|
16095204|NCT02198469|Drug|Er:YAG AFL-PDT|Er:YAG AFL was performed with 350 µm ablation depth, level 1 coagulation, 22% treatment density, and a single pulse. MAL cream was then applied under occlusion for 3 hrs and illuminated with a red light-emitting diode light at 37 J/cm2.
16095205|NCT02198469|Drug|MAL-PDT|a 1-mm thick layer of MAL (16% Metvix® cream, PhotoCure ASA, Oslo, Norway) was applied to the lesion and to 5 mm of surrounding healthy tissue. The area was covered with an occlusive dressing (Tegaderm, 3M, Saint Paul, MN, US) for 3 hours, after which the remaining cream was removed with saline gauze, and the red fluorescence of porphyrins was visualized with Wood's light. Each treatment area was then separately illuminated with red light-emitting diode (LED) lamps (Aktilite CL128; Galderma, Bruchsal, Germany) with peak emission at 632 nm and total light dose of 37 J cm-2. Areas scheduled to receive MAL-PDT received the second treatment 7 days later.
16095206|NCT02198443|Drug|Tenofovir + emtricitabine (Truvada),+lopinavir/ritonavir (Kaletra)|(TRUVADA) film-coated 200/245 mg tablet / day tablets (Kaletra) film-coated 200/50 mg tablets twice / day tablets
16095207|NCT02198443|Drug|elvitegravir/cobicistat/emtricitabine/Tenofovir-Disoproxil|Film-coated tablets of 150 mg of elvitegravir, cobicistat 150 mg, 200 mg of emtricitabine and 245 mg of tenofovir disoproxil. One tablet once / day.
16095208|NCT02198417|Drug|Metformin ER|Treatment with metformin ER for 12 weeks
16095209|NCT02198404|Drug|sedation with propofol|induction with propofol at 20mg/kg/h. Then, when the patient is sleeping, dosage is decreased to 6 mg/kg/h
16095210|NCT02198378|Drug|MEOPA and paracetamol|The patient will be equipped with a facemask after he/she has been informed. The facemask is adapted to the patient. The patient breathes normally in the mask which is held in place by a member of the SMUR team who has received previous training in use of MEOPA. The gas flow received by the patient is adapted to his/her ventilation.
16095211|NCT02198378|Drug|Morphine|Bolus of 2 mg intravenously if EN = 4 or 5 and 3 mg bolus if EN> 6 followed by reinjection of 2mg every 5 minutes until effective analgesia.
16095212|NCT02198352|Drug|BIBN 4096 BS - in single rising doses|
16095213|NCT02198352|Drug|Placebo|
16095214|NCT02198339|Drug|BIBN 4096 BS|
16095215|NCT02198339|Drug|Placebo|
16095216|NCT02198326|Drug|BIBN 4096 BS- in single rising doses|
16095217|NCT02198326|Drug|Placebo|
16095218|NCT02198313|Drug|BIIX 1 XX - D1|
16095219|NCT02198313|Drug|BIIX 1 XX - D2|
16095220|NCT02198313|Drug|BIIX 1 XX - D3|
16095221|NCT02198313|Drug|Placebo|
16095222|NCT02198300|Procedure|Coronary angioplasty with stent implantation|
16095223|NCT02198300|Drug|Dual antipletlet therapy (DAPT)|DAPT given to each patient before stent implantation
16095224|NCT02198287|Drug|BIIX 1 XX inhalation solution|single doses of 800, 1000, 1200, 1400, 1600, 1800, or 2000 mcg
16095225|NCT02198287|Drug|Placebo|
16095226|NCT02198274|Drug|BIBH 1|100 mg/week
16095227|NCT02198261|Drug|5% minoxidil topical foam|5% minoxidil topical foam
16095228|NCT02198248|Drug|Rituximab|Patients will be administered rituximab (375mg/m2/w x4 infusions) for reducing glucocorticoid dose in remission induction phase.
16095229|NCT02198248|Drug|Glucocorticoids|"Low-dose group commenced 0.5mg/kg/day, then taper and stop within 6 months following pre-defined schedule.
~High-dose group commenced 1.0mg/kg/day, then taper to 10mg/day within 6 months following pre-defined schedule."
16095230|NCT02198235|Drug|Dexamethasone|
16095231|NCT02198235|Drug|Buprenorphine|
16095232|NCT02198209|Drug|Liraglutide|"acute study: one injection of 0.6 mg s.c. before IVGTT
~chronic study: 6 weeks of daily liraglutide administration (1 week at 0.6 mg, 1 week at 1.2 mg, 4 weeks at 1.8 mg, s.c)."
16095233|NCT02198196|Behavioral|Weight Talk-Mindfulness|
16095234|NCT02198183|Device|Casmed Fore-Sight Elite|
16095235|NCT02198183|Device|Non-invasive Cardiac Output Monitor (NICOM)|
16095236|NCT02198170|Drug|ketoconazole-placebo|Treatment Period 1: 400 mg ketoconazole orally once daily + single oral dose of 5 mg lenvatinib on fifth day of 19-day treatment period. Treatment Period 2: Placebo orally once daily + single oral dose of 5 mg lenvatinib of fifth day on 19-day treatment period.
16095237|NCT02198170|Drug|placebo-ketoconazole|Treatment Period 1: Placebo orally once daily + single oral dose of 5 mg lenvatinib on fifth day of 19-day treatment period Treatment Period 2: 400 mg ketoconazole orally once daily + single oral dose of 5 mg lenvatinib on fifth day of 19-day treatment period
16095238|NCT02198157|Other|urinary catheterization|nullipara women with epidural anaesthesia who pose urination difficulty will be randomize to receive intermittent or continuous urinary catheterization.
16095239|NCT02198144|Other|barbershop-based BP measurement|BP Measurements and blood pressure reducing medication
16095240|NCT02198131|Procedure|laser therapy|Undergo pulsed dye laser
16095241|NCT02198131|Other|questionnaire administration|Ancillary studies
16095242|NCT02198118|Other|Domiciliary exercises for the upper limbs|Study group (SG) instructed to perform domiciliary exercises for the upper limbs.
16095243|NCT02198105|Device|Cutting-Balloon-PTA (VascuTrak) and Drug Coated Ballon PTA|"Interventional procedure:
~PTA with Cutting-Balloon (60-120 seconds).
~PTA with DC-Balloon (60 seconds).
~Technical success is defined as
~no recoil >30%
~no dissection >Type B
~no stenting >30% of lesion length."
16095244|NCT02198092|Other|Epi proColon Testing|"Plasma specimens will be collected and processed according to the Instructions for Use of the Epi proColon investigational device.
~For circulating colonic epithelial cell analysis, at least one ml whole blood will be required for analysis. Samples will be analyzed for circulating epithelial cells using the geometrically enhanced immunocapture device (GEDI; Gleghorn et al., 2009). Circulating epithelial cells will be captured using EpCAM antibodies and quantified by immunofluorescence microscopy as defined as cells that are DAPI+, CK+, CD45-. Captured cells will be fixed and stored at -20˚C."
16095245|NCT02198079|Biological|Sputum|
16095246|NCT02198066|Other|Dry Sterile Dressing|Described in Arm Description.
16095247|NCT02198066|Other|Metallic Silver Dressing|Described in Arm Description.
16095248|NCT02198066|Other|Ionic Silver Dressing|Described in Arm Description.
16095249|NCT02198040|Other|Manual Therapy|"5 minutes. Termotherapy shalow to 50 cm away from the elbow, using a bulb of 250w.
~15 minutes. Joint traction of elbow, in submaximal mobility amplitude with distal fixation of humerus and proximal fixation of radius and ulna in neutral position of forearm. Joint traction in I-II degree of flexion and extension submaximal of elbow.
~15 minutes. Passive muscle stretching (within the limits of mobility).
~15 minutes. Proprioceptive neuromuscular facilitation (PNF) of upper limb, from the abduction, flexion and external rotation of shoulder.
~10 minutes. Local cryotherapy with ice bag and protection between it and the skin"
16095250|NCT02198040|Other|Educational group|"Theory: Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of elbow; Anatomy of elbow musculature. Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations and treatment; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.
~Practice: exercises in favor of gravity; isometric and isotonic exercises of elbow; active exercises for mobility and pain management; elbow proprioception exercises; and swimming technique."
16095251|NCT02198027|Drug|Bupivacaine|23 G spinal needle will be introduced along the nephrostomy tube for peri-tubal infiltration of 10 ml of 0.25 % Bupivacaine into renal capsule to skin.
16095252|NCT02198027|Other|Normal saline infiltration|23 G spinal needle will be introduced along the nephrostomy tube for peri-tubal infiltration of 10 ml of normal saline into renal capsule to skin
16095253|NCT02198014|Other|Manual Therapy|"5 minutes. Thermotherapy shallow to 50 cm away from the knee. 15 minutes. Joint traction, grade I-II. Fixation of distal femur with cinch and manual fixation of proximal tibia. Patient in prone position and the traction is carried out in the submaximal ranges of flexion and extension.
~10 minutes. Passive muscle stretching of quadriceps (within the limits of mobility), through compression muscle, passive muscle stretching and relaxation of muscle.
~10 minutes. Isometric and resisted exercises of quadriceps, in submaximal ranges, of flexion and extension.
~10 minutes. Proprioception exercises with unipodal support, with and without visual support, and posterior destabilization.
~10 minutes. Local cryotherapy with ice pack."
16095254|NCT02198014|Other|Educational Physiotherapy|"Theory. Introduction to hemophilia: clinic and treatment; Anatomy and biomechanics of knee; Anatomy of ankle musculature; Function of muscles and haematomas treatment; Haemarthrosis, synovitis and arthropathy: clinical manifestations; Proprioception: definition and importance in hemophilia; and Physical activity and sport: risks and benefits.
~Practice: exercises in favor of gravity; active exercises for mobility and pain management; knee proprioception exercises; isometric and isotonic exercises of quadriceps; swimming and cycling technique."
16095255|NCT02198001|Drug|tooth extraction with antibiotics (amoxicillin- clavulanate, clindamycine)|"BPs per os< 3ans: amoxicillin- clavulanate J-1 à J+10
~BPs IV ou per os> 3ans ou per os + comordibities (diabetes, immunosuppression, tobacco):
~amoxicillin- clavulanate J-3 à J+10
~In case of allergy:
~BPs per os: clindamycine J-1 à J+10
~BPs IV ou per os> 3ans ou per os + comordibities (diabetes, immunosuppression, tobacco):
~clindamycine J-3 à J+10"
16095256|NCT02198001|Procedure|atraumatic extraction|Atraumatic tooth extraction, alveolar bone reduction, hermetic mucosal closure
16095257|NCT02197988|Drug|Exparel 1.33% (20ml Volume)|Transversus Abdominis Plane Block
16095258|NCT02197988|Drug|0.125% bupivicaine with 2 mcg/ml Fentanyl.|Thoracic Epidural Anesthesia
16095259|NCT02197975|Drug|PT010 Dose 1|PT010 Dose 1; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations.
16095260|NCT02197975|Drug|PT010 Dose 2|PT010 Dose 2; Budesonide, Glycopyrrolate, and Formoterol Fumarate (BGF) Inhalation Aerosol. Administered as 2 inhalations.
16095261|NCT02197975|Drug|Placebo MDI|Placebo MDI. Administered as 2 inhalations
16095262|NCT02197962|Device|Extracorporeal Radial shockwaves|Patients will receive 2,000 impulses of extracorporeal radial shockwaves or per week, with pressure of 2.5bar to 4.0bar, at the frequency of 8Hz. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.
16095263|NCT02197962|Device|Placebo Radial Shockwaves|Patients will receive 2,000 impulses of placebo extracorporeal radial shockwaves per week, without any pressure, therefore no energy will be applied, at the frequency of 8Hz. The impulses will be applied at the most painful site of the knee joint interface on manual palpation, for three consecutive weeks.
16095264|NCT02197923|Procedure|Myometrial biopsy|transvaginal ultrasound guided biopsy of the myometria
16095265|NCT02197923|Procedure|endometrial biopsy|transcervical endometrial biopsy
16095266|NCT02197910|Other|Comparisons of two kind of pasta with low or high content of wheat bioactive peptides (sequence Low->High)|
16095267|NCT02197910|Other|Comparisons of two kind of pasta with low or high content of wheat bioactive peptides (sequence High->Low)|
16095268|NCT02197897|Drug|Tamoxifen Citrate|Single-center, two-stage phase-II clinical trial (Simon design)
16095269|NCT02197884|Drug|JNJ-54861911, 25 mg|JNJ-54861911, 25 mg tablet orally on Day 1 and Day 9.
16095270|NCT02197884|Drug|Itraconazole 200 mg|Itraconazole 200 mg (2*100 mg capsule) orally once daily from Day 5 to Day 12.
16095271|NCT02197884|Drug|Clarithromycin 500 mg|Clarithromycin 500 mg immediate release tablet orally twice daily from Day 5 to Day 12.
16095272|NCT02197871|Dietary Supplement|enteral nutrition emulsion|The patient should drink the oral nutritional supplements according to the estimated energy intake and make a record everyday.The patients will be followed up regularly.
16095273|NCT02197845|Behavioral|Patient Navigator|A specially trained (SCD knowledgable) Patient Navigator will act as a liaison who assists participants in increasing adherence to HU through disease education, addressing barriers to care and improving adherence to HU. PN utilize various techniques geared toward the individual patients needs. Interventions utilized by a PN include improving disease management skills, educational materials about disease, HU adherence, motivational interviewing, care coordination and social support.
16095274|NCT02197845|Behavioral|Recruitment into Specialty Care|A specially trained (SCD knowledgeable) Patient Navigator will act as a liaison to participants in increasing adherence to Hydroxyurea. Interventions utilized by a PN include teaching disease management skills, addressing barriers to care, disease education, HU management, motivational interviewing, care coordination and social support.
16095275|NCT02197832|Procedure|Endometrial biopsy|The procedure was performed in a standard approach using a Pipelle catheter (Pipelle de Cornier, Laboratoire C.C.D., France). The pipelle catheter was introduced through the cervix up to the uterine fundus. The piston was drawn back to the end of the sheath to create a negative pressure. The sheath was rotated and moved back and forth between the fundus and internal os for at least 3-4 times before it was gently withdrawn.
16095276|NCT02197832|Procedure|control procedure|Using pipelle catheter without entering the uterine cavity.
16095277|NCT02197832|Device|Pipelle catheter (Pipelle de Cornier, Laboratoire C.C.D., France)|
16095278|NCT02197819|Device|Sling|
16095279|NCT02197819|Device|External Rotation Brace|
16095280|NCT02197806|Drug|AGN-199201|1 to 2 drops of AGN-199201 ophthalmic solution in the eye(s) as per protocol.
16095281|NCT02197806|Drug|AGN-190584|1 to 2 drops of AGN-190584 ophthalmic solution in the eye(s) as per protocol.
16095282|NCT02197806|Drug|AGN-199201 Vehicle|1 to 2 drops of AGN-199201 vehicle in the eye(s) as per protocol.
16095283|NCT02197793|Behavioral|Community Mobilization Program|
16095284|NCT02197767|Drug|rituximab|1000 mg infusion
16095285|NCT02197754|Other|Controlled diet|"Volunteers will be provided a controlled diet during the entirety of the 10 week treatment period. Meals will be prepared using traditional American foods.
~The controlled diet will include polyphenol-rich foods, including apples, berries, and green tea. A blend of multiple polyphenol-rich foods was chosen to investigate whole foods, multiple commodities, and multiple bioactives."
16095286|NCT02197741|Drug|opiate with bolus|
16095287|NCT02197728|Device|Use of the Colpo-Probe™ Vaginal Fornix Delineator or Hohl manipulator® during total laparoscopic hysterectomy|
16095288|NCT02197715|Behavioral|Computer-adaptive SAFE|
16095289|NCT02197715|Behavioral|Face-to-face SAFE|
16095290|NCT02197715|Behavioral|Usual Care|
16095291|NCT02197702|Dietary Supplement|vitamin D|Two doses of cholecalciferol 100,000 unit (2 mL) given 3.5 months apart, once in the fall, once in the winter
16095292|NCT02197702|Dietary Supplement|placebo|Two doses of identical placebo (2 mL) given 3.5 months part, once in the fall, once in the winter
16095343|NCT02197247|Procedure|Pharmacokinetic sampling - AZ5140 and AZ7550|Blood samples to measure levels of AZ5140 and AZ7550
16095293|NCT02197689|Device|Personalized Medication Management Platform for SMS Reminder|The Personalized Medication Management Platform was developed by investigators that integrated with Hospital Information System (HIS) to collect the prescription information of patients and automatically send SMS to remind
16095294|NCT02197676|Drug|SGI-110 administration|"SGI-110 will be administered SC at 60 mg/m²/day x5 consecutive days for each cycle. Cycle duration is 28 days. Patients with Complete Remission (CR), Partial Remission (PR), marrow CR or Hematological Improvement (HI) after 6 Cycles of therapy (IWG 2006 criteria) may continue treatment until progression.
~A dose reduction to 45 and even 30 mg/m²/day will be made in case of haematological toxicity. Patients with no response (NR) to treatment will be withdrawn from the protocol after the last treatment Cycle."
16095295|NCT02197663|Procedure|acupuncture(44mm in length and 32-gauge)|"The whole course of the acupuncture contains 24times(about 3 months). The acupoints are fixed and located over head and limbs.
~The whole course of the sham acupuncture contains 24times(about 3 months). The acupoints are fixed and 1cm away from meridian and no acupoints over head were chosen."
16095296|NCT02197650|Drug|suspension of erythrocytes encapsulating L-asparaginase|Erythrocytes encapsulating L-asparaginase
16095297|NCT02197637|Drug|ORAL VINORELBINE|Orally vinorelbine 60 mg/m2 D1, 8 and 15 Cycle of 28 days For a maximum of 12 cycles The dose of vinorelbine should be increased to 80 mg/m2 from the 2nd cycle If on D8 and D15, the administration conditions are not met, the administration is canceled and not delayed.
16095298|NCT02197598|Drug|nalmefene|
16095299|NCT02197585|Procedure|Inguinal mesh hernioplasty|
16095300|NCT02197572|Drug|Sapanisertib|Sapanisertib capsules.
16095301|NCT02197559|Procedure|DES group|all the participants in this group will be performed with drug -eluting stents
16095302|NCT02197559|Procedure|BMS group|all the participants in this group will be performed with bare-metal stents
16095303|NCT02197546|Other|Acupuncture & acupressure|Bilateral acupuncture with indwelling fixed needles 1.5 mm length with subsequent acupressure by the parents
16095304|NCT02197533|Other|Written List|Written list of seven management strategies for OAB to be produced during verbal discussion about management.
16095305|NCT02197520|Drug|Insulin Peglispro|Administered subcutaneously (SC), (U-100 formulation)
16095306|NCT02197520|Drug|Insulin Glargine|Administered subcutaneously (SC), (U-100 formulation)
16095307|NCT02197520|Drug|Insulin Lispro|Administered subcutaneously (SC), (U-100 formulation)
16095308|NCT02197507|Device|Digitized sensor|Measure of grip strength of the dominant hand
16095309|NCT02197494|Drug|Valsartan|320mg tablets
16095310|NCT02197481|Procedure|Clamp-Crushing technique|Liver transection during hepatectomy by monopole electronicknife and blood vessel forceps, but without BiClamp forceps
16095311|NCT02197481|Device|BiClamp forceps|liver transection during hepatectomy by BiClamp forceps
16095312|NCT02197455|Drug|Tofacitinib Administration|5 mg of Tofacitinib will be taken by mouth twice daily for 3 months.
16095313|NCT02197442|Drug|Valsartan|
16095314|NCT02197429|Other|Acupuncture|
16095315|NCT02197416|Drug|dabigatran etexilate|Age and weight appropriate capsule dose (combination of 50 mg, 75 mg and 110 mg capsules) or pellets or oral liquid formulation
16095316|NCT02197403|Drug|Dexmedetomidine|200mcg in 50mL of normal saline 0.75mcg/Kg bolus injection in 10 minutes 0.1~1.0mcg/Kg infusion
16095317|NCT02197403|Drug|Propofol|25~75mcg/kg/min continuous infusion
16095318|NCT02197390|Behavioral|Family wellness workshops|Nine family wellness workshops and eight family physical activity sessions facilitated by community health workers.
16095319|NCT02197390|Behavioral|Obesity chronic care model|
16095320|NCT02197390|Behavioral|Physical activity, healthy eating, water drinking, healthy sleep promotion|
16095321|NCT02197390|Behavioral|Environment, policy, systems changes in clinic setting only|
16095322|NCT02197390|Behavioral|No intervention|No intervention.
16095323|NCT02197390|Behavioral|Environment, policy, and systems changes in schools, early child care education & recreation|
16095324|NCT02197377|Device|Group LMA Unique™|The supraglottic airway devices were deflated fully before insertion. After placement an effective airway was defined as the presence of normal thoracoabdominal movement and a square-wave end-tidal carbon dioxide trace.
16095325|NCT02197377|Device|Group LMA Supreme™|The supraglottic airway devices were deflated fully before insertion.The supraglottic airway devices were deflated fully before insertion. After placement an effective airway was defined as the presence of normal thoracoabdominal movement and a square-wave end-tidal carbon dioxide trace.
16095326|NCT02197351|Procedure|White light biopsy|Endoscopy with biopsies guided by high definition white light
16095327|NCT02197351|Procedure|Protocolled|Upper Endoscopy with Protocolled Biopsy (i.e. biopsy by predetermined guideline not influenced by white light or narrow band imaging findings)
16095328|NCT02197351|Procedure|Narrow Band Imaging Guided Biopsy|Upper Endoscopy with biopsy guided by narrow and imaging
16095329|NCT02197338|Other|Bile Duct Cannulation|Initial bile duct cannulation (first 8 attempts) will be made in each subject using one of the four cannulation strategies described in the 4 arms. The arm for each subject will be assigned by randomziation.
16095330|NCT02197325|Device|PICSO|Pressure controlled Intermittent Coronary Pressure Occlusion
16095331|NCT02197312|Device|NobelProcera Bridge Shaded Zirconia|
16095332|NCT02197299|Dietary Supplement|L-carnitine|
16095333|NCT02197299|Dietary Supplement|Placebo|
16095334|NCT02197286|Drug|Cholecalciferol|One capsule containing 4,000 IU of Cholecalciferol, per day
16095335|NCT02197286|Drug|Placebo|Daily dose of a single gelatin placebo capsule.
16095336|NCT02197273|Drug|Liposomal bupivacaine|
16095337|NCT02197273|Drug|Standard of care analgesia|
16095338|NCT02197260|Drug|3/d 500 mg metronidazole plus 375 mg amoxicillin for 7 days|Systemic antibiotics after sub gingival mechanical debridement
16095339|NCT02197247|Procedure|Pharmacokinetic sampling - AZD9291|Blood sampling to measure AZD9291
16095340|NCT02197247|Drug|Rifampicin|Rifampicin (CYP inducer) 600mg taken once daily from Day 29 to Day 49 (Part A)
16095341|NCT02197247|Drug|AZD9291 tablet dosing|Part A: AZD9291 80mg tablet taken daily from Days 1 to 77. Part B: AZD9291 80mg tablet taken daily for 12 months.
16095342|NCT02197247|Procedure|Pharmacokinetic sampling - rifampicin|Blood sampling to measure rifampicin levels
16095345|NCT02197234|Drug|Simvastatin|Simvastatin (CYP substrate) 40mg taken once daily on Days 1 and 31 (Part A)
16095346|NCT02197234|Drug|AZD9291 tablet dosing|AZD9291 80mg tablet taken from Days 3 to 32. (Part B) AZD9291 80mg tablet taken daily for 12 months.
16095347|NCT02197234|Procedure|Pharmacokinetic sampling - simvastatin|Blood sampling to measure simvastatin levels
16095348|NCT02197234|Procedure|Pharmacokinetic sampling - AZ5140 and AZ7550|Blood samples to measure levels of AZ5140 and AZ7550
16095349|NCT02197221|Drug|Bortezomib-Melphalan|Bortezomib will be administered on days: -6, -3, +1, +4. Melphalan will be administered on day -2. The PBSC will be injected on day 0.
16095350|NCT02197221|Drug|Melphalan|Melphalan will be administered on day -2. The PBSC will be injected on day 0.
16095351|NCT02197208|Procedure|Daily monitoring of LH and E2|ultrasound scanning would be carried out from 18 days before the expected period to confirm follicular growth, followed by daily blood monitoring of serum E2 and LH levels when the dominant follicle reaches 13-14mm in diameter. Ultrasound scanning can be arranged accordingly if the leading follicle remains less than 10mm in diameter. 5 ml of blood would be taken daily. LH surge is defined as the LH level being double of the average of the previous three days and higher than 20 IU/L. Ultrasound examination will be performed on the next day after the LH surge to measure the endometrial thickness. The transfer will be scheduled three or four days after the LH surge (for cleavage stage embryos) or six days after LH surge (for blastocyst transfer).
16095352|NCT02197208|Procedure|hCG induced natural cycle|ultrasound monitoring would be started from 18 days before the expected period to monitor follicular growth, followed by USG every 2-3 days. hCG, 5,000-10,000 IU will be given when the leading follicle is >/= 17 mm and the endometrium measures >/=8 mm. Serum E2, LH and progesterone levels will be measured on the day of hCG. Embryo transfer would be scheduled on the fourth or fifth days after hCG injection (for cleavage stage embryos) or seventh days (for blastocyst transfer).
16095353|NCT02197208|Device|ultrasound|
16095354|NCT02197195|Dietary Supplement|Chocolate Milk|
16095355|NCT02197195|Dietary Supplement|Fruit Drink|
16095356|NCT02197195|Behavioral|Exercise|
16095357|NCT02197182|Drug|LUXSOL copper containing cream|Active comparator arm
16095358|NCT02197182|Drug|Metronidazole gel|Active comparator for treatment of bacterial vaginosis
16095359|NCT02197169|Drug|Single intratumoral injection of DNX-2401|"In the randomized group, following brain tumor biopsy and histological confirmation of recurrent glioblastoma/gliosarcoma, a single injection of DNX-2401 was administered directly into the brain tumor with or without subsequent interferon gamma (IFN-γ)
~No additional subjects will be randomized. A single intratumoral dose of DNX-2401 will be delivered by cannula."
16095360|NCT02197169|Drug|Interferon-gamma|In the randomized group, a single injection of DNX-2401 was followed by interferon gamma (IFN-γ). No additional subjects will be randomized or receive IFN-γ following DNX-2401
16095361|NCT02197156|Drug|10 mg HC-ER|Single dose
16095362|NCT02197156|Drug|20 mg HC-ER|Single dose
16095363|NCT02197156|Drug|30 mg HC-ER|Single dose
16095364|NCT02197156|Drug|40 mg HC-ER|Single dose
16095365|NCT02197156|Drug|10 mg HC / 325 mg APAP|Single dose
16095366|NCT02197156|Drug|Matching Placebo|Single dose
16095367|NCT02197143|Drug|esomeprazole|40 mg esomeprazole in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
16095368|NCT02197143|Drug|Ranitidine|50mg Ranitidine in 150 ml normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
16095369|NCT02197143|Drug|hydrotalcid|150 ml only normal saline given as a slow intravenous infusion over 15 minutes and p.o. 10ml Hydrotalcid
16095370|NCT02197130|Drug|PF-02545920|20 mg twice a day (BID) for 26 weeks. Each 20 mg dose will be taken as 4 tablets of 5 mg. The 20mg dose will be titrated as follow: 5mg BID for 7 days, 10mg BID for 7 days, 15 mg BID for 7 days and 20 mg BID to week 26. Study drug will be provided in weekly blister cards.
16095371|NCT02197130|Drug|PF-02545920|5 mg twice a day (BID) for 26 weeks. Each 5 mg dose will be taken as 4 tablets: one tablet of 5 mg and 3 tablets of matching placebo. The 5mg dose will not be titrated. Study drug will be provided in weekly blister cards.
16095372|NCT02197130|Other|Placebo|Matching Placebo twice a day (BID) for 26 weeks. Each placebo dose will be taken as 4 tablets of matching Placebo. The placebo dose will not be titrated. Matching placebo will be provided in weekly blister cards.
16095373|NCT02197117|Device|Remote ischemic conditioning|
16095374|NCT02197117|Device|Control|
16095375|NCT02197104|Drug|citocoline|
16095376|NCT02197091|Other|questionnaire administration|Ancillary studies
16095377|NCT02197091|Other|medical chart review|Ancillary studies
16095378|NCT02197065|Drug|Atorvastatin|Atorvastatin or placebo will be started at least 4 hours prior to surgery, and continued nightly until postoperative day 45
16095379|NCT02197065|Drug|Placebo|
16095380|NCT02197039|Drug|esomeprazole or pantoprazole|Each enrolled patient receives an 80 mg loading dose of intravenous esomeprazole (Nexium®, AstraZeneca AB, Södertälje, Sweden) immediately after hemostasis is achieved spontaneously or by gastroscopy. Patients then receive a 3-day continuous high dose (8 mg per hour) of esomeprazole infusion. Because of concern for patient safety with certain drug-drug interactions, patients who take clopidogrel receive intravenous pantoprazole (Pantoloc®, Takeda, Singen, Germany), including an 80 mg loading dose and a 3-day continuous high-dose (8 mg/h) of infusion.
16095381|NCT02197039|Procedure|Endoscopic hemostasis|At the index gastroscopy, bleeding ulcers are checked. If the adherent clot is found over the ulcer base, it will be vigorously washed away with water jet. All of the stigmata of recent hemorrhage (SRH) are treated by one or a combination of endoscopic therapies including local injection of diluted epinephrine 1:10000, bipolar heated probe at 20 J per goal consecutively until achievement of coaptive coagulation, argon plasma coagulation, band ligation, or hemoclip therapy. The success of endoscopic hemostasis is defined as cessation of bleeding together with achievement of cavitation at the vessel after application of the heater probe.
16095382|NCT02197026|Drug|Hylan G-F 20|
16095383|NCT02197026|Drug|Standard treatment|Standard drug treatment at the discretion of the investigator
16095384|NCT02197026|Procedure|Physiotherapy|
16095385|NCT02197026|Procedure|Hydrotherapy|
16095386|NCT02197000|Dietary Supplement|DIM-Avail 100mg|DIM 100 mg*1 daily for 2 years
16095387|NCT02196987|Other|Urination during urethral catheterisation|Requesting the patient to urinate while inserting urethral catheter
16095388|NCT02196987|Other|Urethral catheterisation, without further guidance|Lying, inserting urethral catheter, without further guidance from health care professional
16095389|NCT02196974|Procedure|cryobiopsy|
16095390|NCT02196961|Drug|Nivolumab|adjuvant treatment of completely resected Merkel cell carcinoma
16095391|NCT02196948|Other|Electrolysis Percutaneous Therapeutic (EPTE)|
16095392|NCT02196948|Other|Eccentric exercise|
16095393|NCT02196935|Other|clinical course|Detailed presentation including labs, demographics, imaging of those who undergo ERCP/EUS with be prospectively recorded. Details of procedure including sedation strategy and success will be collected. Results of procedure including final pathology results with be recorded.
16095394|NCT02196922|Device|Telehealth Self Management (TSM)|Experimental: Telehealth Self Management (TSM) TSM is defined as a weekly clinical telehealth visit and self-monitoring of daily vital signs utilizing a subject monitor which connects from the subject's residence, via a standard telephone line to the provider station.
16095395|NCT02196922|Other|Standard of Care|Patients receiving standard of care experience typical chronic care management received by Medicare patients.
16095396|NCT02196909|Other|motor function and strength assessment|
16095397|NCT02196909|Other|NMR assessment|
16095398|NCT02196909|Other|24h urine and serum collection|
16095399|NCT02196896|Other|deprexis®|Online self-help program in addition to inpatient psychosomatic treatment for 90 days.
16095400|NCT02196896|Other|Information|The patients receive online information about depression once a week for 90 days.
16095401|NCT02196883|Procedure|Transforaminal Epidural Steroid Injection|
16095402|NCT02196857|Drug|Azacytidine|75 mg/m2 administered subcutaneously (SQ) or intravenously (IV) on Days 1 - 7 for a 28 day cycle.
16095403|NCT02196857|Drug|Sorafenib|400 mg by mouth twice daily about 12 hours apart, every day for a 28 day cycle.
16095404|NCT02196844|Behavioral|Hatha Yoga|5-6 weeks of a couple-based yoga program, three sessions per week (up to 15 sessions) during radiation treatment.
16095405|NCT02196844|Behavioral|Questionnaires|10 questionnaires completed before first radiation treatment, each week during radiation, 5 questionnaires halfway through radiation treatment schedule. at radiation treatment completion, and again 3 months later.
16095406|NCT02196844|Other|Walk Test|6-minute walk test performed at baseline, at the end of radiation therapy, and 3 months after radiation therapy.
16095407|NCT02196831|Drug|tesamorelin|
16095408|NCT02196831|Drug|Placebo|inactive substance that looks like tesamorelin
16095409|NCT02196818|Device|Mpact Acetabular Shell|Total Hip Replacement
16095410|NCT02196805|Drug|Group A: imported Probucol ( Lorelco)|Group A: take imported Probucol( Lorelco) (250mg/tablet), Qd, P.O.
16095411|NCT02196805|Drug|Group B: Marketed Probucol ( Chang Tai)|Group B: take Marketed Probucol(Chang Tai)(250mg/tablet), Qd, P.O.
16095412|NCT02196792|Device|E-Poly liner|E-Poly liner with a titanium cup
16095413|NCT02196792|Device|ArComXL liner|ArComXL liner with a titanium cup
16095414|NCT02196792|Device|32 mm femoral head|Stem with a 32 mm CoCr femoral head
16095415|NCT02196792|Device|36 mm femoral head|Stem with a 36 mm CoCr femoral head
16095416|NCT02196766|Other|Bioclean First Care EX / comfilcon A|Subjects dispensed Bioclean First Care EX / comfilcon A combination then crossed over to the alternate combination.
16095417|NCT02196766|Other|Aosept Clearcare / comfilcon A|Subjects dispensed Aosept Clearcare / comfilcon A combination then crossed over to the alternate combination.
16095418|NCT02196753|Other|PET CT|"All patients are examined by a physicians before PET CT and if there are no contraindications they are given isotope intravenously. Then they stay in a warm waiting room. The dose of 18-FDG depends on patient's weight and varies from 270 to 420 MBq. Isotope uptake time is about 45-180 minutes. After that time the patient is asked to empty his or her bladder and go to the examination room. First CT scan lasting 2 min is performed followed by the PET scan lasting about 20 min. Usually area from mid tigh to eye level is scanned.
~In PET we use iterative reconstruction method (number of subsets 28, number of iterations 2), time of acquisition in one position of a table - 2 minutes. The following parameters will be analyzed: standardized uptake value (SUV) in the CIED area (pocket, leads), SUV of vascular background - pulmonary trunk, SUV of a liver, SUV max. in other potential changed areas, volume with increased SUV> 40% of the background."
16095419|NCT02196740|Drug|Metronidazole-Ciprofloxacin gatifloxacin-Clindamycin paste|Pulp removal,Root canal irrigation and disinfection,
16095420|NCT02196740|Drug|creosote|Pulp removal,Root canal irrigation and disinfection
16095421|NCT02196714|Drug|Glycopyrronium and Formoterol Fumarate (GFF) Dose 1|Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 1; PT003 administered as 2 inhalations twice-daily (BID)
16095422|NCT02196714|Drug|Glycopyrronium and Formoterol Fumarate (GFF) Dose 2|Glycopyrronium and Formoterol Fumarate metered-dose inhaler MDI (GFF MDI), Dose 2; PT003 administered as 2 inhalations twice-daily (BID)
16095423|NCT02196714|Drug|Glycopyrronium (GP) Dose 1|Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 1; PT001 administered as 2 inhalations twice-daily (BID)
16095424|NCT02196714|Drug|Glycopyrronium (GP) Dose 2|Glycopyrronium metered-dose inhaler MDI (GP MDI), Dose 2; PT001 administered as 2 inhalations twice-daily (BID)
16095425|NCT02196701|Drug|Adalimumab|Administered by subcutaneous injection every other week.
16095426|NCT02196701|Drug|Methotrexate|Methotrexate was provided as 2.5 mg tablets for oral administration.
16095427|NCT02196688|Drug|fruquintinib|fruquintinib is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off
16095428|NCT02196688|Drug|placebo|Placebo is a capsule in the form of 1mg and 5mg, orally, once daily, 3 weeks on/ 1 week off
16095429|NCT02196675|Device|Endocutter|The study utilized Echelon FlexTM Powered ENDOPATH® Stapler (Ethicon, Cincinnati, USA) along with compatible cartridges: Gray (closed staple height, 0.75mm), White (1.0mm), Blue (1.5mm), Gold (1.8mm), Green (2.0mm), and Black (2.3mm).
16095430|NCT02196662|Drug|IBD98-M:|single adiministration
16095431|NCT02196662|Drug|IBD98-M without HA|single adiministration
16095432|NCT02196662|Drug|Delzicol|single adiministration
16095433|NCT02196649|Device|Endoscopic Clip|
16095434|NCT02196636|Drug|Placebo|Matching placebo, administered orally with approximately 240 mL of buffer
16095435|NCT02196636|Drug|RO6806127|Administered orally with approximately 240 mL of buffer
16095436|NCT02196623|Other|Hypoxic exercise|Supervised, progressive aerobic exercise program for 8 weeks under hypoxic conditions
16095437|NCT02196623|Other|Normoxic Exercise|Supervised, progressive aerobic exercise program for 8 weeks under normoxic conditions
16095438|NCT02196610|Other|Applanation tonometry|Two consecutive sets of carotid-femoral Pulse Wave Velocity (PWV) measurements by Applanation tonometry with a time-interval of 1 week will be obtained (1 week ± 2 days). Two research assistants will each perform a carotid-femoral-PWV measurement at each time point with the testing order randomized.
16095439|NCT02196571|Other|Structured Exercise|
16095440|NCT02196558|Drug|E6011|
16095441|NCT02196545|Behavioral|Exercise|
16095442|NCT02196532|Device|Device: Optical coherence tomography|
16095443|NCT02196519|Device|Sylys Surgical Sealant|
16095444|NCT02196506|Drug|Placebo + ADT|Placebo + ADT Placebo + FDA Approved Antidepressant (ADT)
16095445|NCT02196506|Drug|Brexpiprazole +ADT|Brexpiprazole + ADT Tablet, Oral, 2mg brexpiprazole and FDA Approved Antidepressant (ADT)
16095446|NCT02196493|Drug|Azithromycin|250mg azithromycin three times per week for 12 weeks
16095447|NCT02196480|Biological|anti-TNF|Anti-tumor necrosis factor therapy
16095448|NCT02196467|Biological|Myoblast transplantation|30 million myoblasts will be transplanted per centimeter cube in the Extensor carpi radialis of one of the patient's forearm, resuspended in saline (a total of 0.5 ml of suspension per centimetre cube of muscle).
16095449|NCT02196467|Procedure|Saline injection|A saline solution (the same used to resuspend de myoblasts in the first intervention) will be injected similarly in the Extensor carpi radialis of the contralateral patient's forearm (a total of 0.5 ml of saline per centimetre cube of muscle).
16095450|NCT02196454|Other|Educational Video with Male or Female Narrator|Participants will watch an educational video about the quadrivalent HPV vaccine (Gardasil) narrated by either a male or female.
16095451|NCT02196441|Drug|2% tetracaine local anaesthetic drops|topical anaesthetic drops
16095452|NCT02196441|Drug|0.5% bupivacaine|was performed using two sponges (2x3mm) soaked with 0.5% bupivacaine, applied deep in the conjunctival fornices after anaesthetising the conjunctiva with tetracaine local anaesthetic drops. The sponges were removed after 15 minutes. The anaesthetic effect was tested by grasping the limbus with Castroviejo 0.12 tissue forceps.
16095453|NCT02196428|Other|Telemonitoring and Teleconsultation|The interventions of this study are supported by a so-called Ambient Assisted Living Wizard (AAL Wizard). This is an IHE-compliant documentation and communication platform with an integrated electronic health record, which enables the study participants (elderly) to manage and store their relevant health data. It includes personal master data and the documentation of telemonitoring data. Additionally, the AAL-Wizard provides the communication modules such as telephone -, video- and time- and online consultation. The tele doctor assess the data (eg, vital signs and content of the medical teleconsultation) and collaborates in this way with the older person, family physicians and other health care providers based on an innovative and flexible telemedical home care service.
16095454|NCT02196415|Device|Biplanar Radiography|standard biplanar radiography of the foot
16095455|NCT02196389|Device|Nasal dilator Nasanita|Nasal Dilator
16095456|NCT02196389|Device|Nasal dilator Nozovent|
16095457|NCT02196389|Device|Nasal dilator Breath Right|
16095458|NCT02196389|Device|Nasal dilator Airmax|
16095459|NCT02196376|Other|History|the physician / PI will conduct a history that may include: demographics Framingham risk factors metabolic diseases inflammatory diseases autoimmune disorders review of medications date of last menstrual period (females) family history of autonomic disorders Onset of postural orthostatic tachycardia syndrome
16095460|NCT02196376|Other|Physical|"the physical exam will include: height weight orthostatic vitals (heart rate and blood pressure), supine and standing for up to 10 minutes.
~Beighton Criteria for Join Hypermobility Syndrome Dependent acrocyanosis"
16095461|NCT02196376|Other|blood draw|"blood will be drawn for: antibodies regulating cardiovascular function inflammatory markers
~no more than 15 ml (1 TBSP) will be drawn."
16095462|NCT02196376|Behavioral|Questionnaires|"The questionnaires will be completed directly online (web-based interface) using a personalized link that will be provided to the subjects after they give their informed consent. These will be created in a REDCap-Survey environment, with the data collected and stored on a password-protected, HIPAA-compliant, secure computer server.
~The following questionnaires will be conducted:
~RAND-36 Health Thermometer Chalder Fatigue Scale Daily diary of Fatigue Symptoms - Fibromyalgia Pain Detect Questionnaire Orthostatic Grading Scale COMPASS-31"
16095463|NCT02196350|Behavioral|Intervention A: Diet|subjects visit the dietitian at week 0, 1, 2, 6, 10 and 13 for dietary advice
16095464|NCT02196350|Behavioral|Intervention B: Exercise|subjects visit the physiotherapist three times weekly; subjects visit the dietitian at week 0, 1, 2, 6, 10 and 13 for dietary advice.
16095465|NCT02196350|Behavioral|Intervention C: Diet and Exercise|subjects visit the physiotherapist three times weekly; subjects visit the dietitian at week 0, 1, 2, 6, 10 and 13 for dietary advice.
16095466|NCT02196324|Drug|serlopitant|NK1 receptor antagonist
16095467|NCT02196324|Drug|Placebo|Placebo
16095468|NCT02196298|Device|Lokomat|16 sessions in total, 30 minutes each plus set-up time followed by 5 minutes of overground walking. Provided by study PT twice weekly for a period of 8 weeks to maximum of 10 weeks.
16095469|NCT02196298|Other|Physiotherapy|16 sessions, 35 minutes. Provided by study PT twice weekly for a period of 8 weeks to maximum of 10 weeks.
16095470|NCT02196285|Biological|Double viral (MR) vaccine|Measles and Rubella vaccine, as single arm
16095471|NCT02196272|Behavioral|Nurse-led reminder program through email|"Both groups will receive an educational program and usual care. The educational program will consist of:
~- 1-hour session, during which the NCM give advices and enphasize the importance of the correct procedure of glycemic control, report non-pharmacological strategies for a healty lifestyle and instruction on how to fill a self assessment form."
16095472|NCT02196259|Drug|Anesthetics, Dissociative|The subject will receive intravenous anesthesia at a dose of 0.5mg/kg delivered over 40 minutes in a constant infusion or bolus plus infusion method to maintain steady state (10 minutes initial induction, 30 minutes steady-state, for 40 minutes total)
16095473|NCT02196207|Drug|Eloctate Prophylaxis|Prevention Trial, Arm A: Eloctate (65 IU/kg) will be administered weekly by intravenous infusion for up to 48 weeks in previously untreated children with severe hemophilia A beginning before the first bleed.
16095474|NCT02196207|Drug|Emicizumab Prophylaxis|Prevention Trial, Arm B: Emicizumab (1.5 mg/kg) will be administered weekly by subcutaneous injection for up to 48 weeks in previously untreated children with severe hemophilia A.
16095475|NCT02196207|Drug|Eloctate ITI plus Emicizumab|Eradication Trial, Arm A: Eloctate (100 IU/kg) ITI every other day by intravenous infusion plus Emicizumab (1.5 mg/kg) weekly by subcutaneous injection will be administered for up to 48 weeks as immune tolerance in children and adults with severe hemophilia A and high-titer inhibitors.
16095476|NCT02196207|Drug|Eloctate ITI|Eradication Trial, Arm A: Eloctate (100 IU/kg) ITI every other day by intravenous infusion will be administered for up to 48 weeks as immune tolerance in children and adults with severe hemophilia A and high-titer inhibitors.
16095477|NCT02196194|Drug|Tiotropium|
16095478|NCT02196181|Drug|Dabrafenib Mesylate|Given PO
16095479|NCT02196181|Drug|Trametinib Dimethyl Sulfoxide|Given PO
16095480|NCT02196168|Drug|Cisplatin|Given IV
16095481|NCT02196168|Other|Laboratory Biomarker Analysis|Correlative studies
16095482|NCT02196168|Other|Pharmacological Study|Correlative studies
16095483|NCT02196168|Other|Placebo|Given PO
16095484|NCT02196168|Drug|WEE1 Inhibitor AZD1775|Given PO
16095485|NCT02196155|Drug|Botulinum toxin A|"Researchers discovered in the 1950s that injecting overactive muscles with minute quantities of botulinum toxin type-A would result in decreased muscle activity. Botulinum toxin type-A has this effect because it prevents the vesicle where the acetylcholine is stored from binding to the membrane where the neurotransmitter can be released. Botulinum toxin type-A thus blocks the release of acetylcholine by the neuron. This will effectively weaken the muscle for a period of three to four months.
~In addition to its cosmetic applications, Botox is currently used in the treatment of spasms and dystonias, by weakening involved muscles, for the 60-70 day effective period of the drug. The main conditions treated with botulinum toxin are: Cervical dystonia (spasmodic torticollis) (a neuromuscular disorder involving the head and neck), Blepharospasm (excessive blinking) etc.."
16095486|NCT02196155|Drug|cortisone|
16095487|NCT02196155|Drug|Saline|
16095488|NCT02196142|Drug|Cortisol 20mg|Drug: Cortisol 20mg
16095489|NCT02196142|Drug|Placebo Mannitol|Drug: Placebo Mannitol
16095490|NCT02196129|Drug|Sinbaro-3|1cc administered to site of pain(ashi acupoints), once and once only before any other intervention/if pain in both low back and extermities, the site of most pain
16095491|NCT02196129|Drug|Hwangryun|1cc administered to site of pain(ashi acupoints), once and once only before any other intervention/if pain in both low back and extermities, the site of most pain
16095492|NCT02196116|Other|PET|PET Scan with [18F]-Flutemetamol
16095493|NCT02196116|Other|MRI|
16095494|NCT02196116|Other|neuropsychological tests|
16095495|NCT02196103|Device|Double balloon cervical catheter|
16095496|NCT02196090|Behavioral|Exposure and Response Prevention|A procedure where patients with OCD test out their fears without responding by compulsive act.
16095497|NCT02196090|Device|Cold face gel mask|Temporary application of cold eye mask on the face is commonly used for relaxation purpose.
16095498|NCT02196077|Drug|BFF MDI 320/9.6 μg|Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 320/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)
16095499|NCT02196077|Drug|BFF MDI 160/9.6 μg|Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 160/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)
16095500|NCT02196077|Drug|BFF MDI 80/9.6 μg|Budesonide and formoterol fumarate metered dose inhaler (BFF MDI) 80/9.6 μg; PT009 administered as 2 inhalations, twice daily (BID)
16095501|NCT02196077|Drug|BD MDI 320 μg|Budesonide metered dose inhaler (BD MDI) 320 μg; PT008 administered as 2 inhalations, twice daily (BID)
16095502|NCT02196077|Drug|FF MDI 9.6 μg|Formoterol fumarate metered dose inhaler (FF MDI) 9.6 μg; PT005 administered as 2 inhalations, twice daily (BID)
16095503|NCT02196051|Other|Exercise Training|Six weeks of exercise
16095504|NCT02196038|Behavioral|multi-domain rehabilitation intervention|Individual, tailored, progressive physical function rehabilitation intervention
16095505|NCT02196038|Behavioral|Attention Control|Usual care with bi-weekly contact from study staff
16095506|NCT02196025|Device|Transcranial magnetic stimulation|Patients will receive sequential bilateral bifrontal low frequency TMS stimulation daily on weekdays for three weeks. In addition, a Pittsburgh Sleep Quality Index (PSQI), Insomnia severity rating index, Montgomery Asberg Depression Rating Scale, and a sleep diary will be kept.
16095507|NCT02196012|Behavioral|Intervention group|
16095508|NCT02196012|Behavioral|attention control condition|
16095509|NCT02195999|Other|Magnetic Resonance Imaging (MRI)|It is a non-invasive method to determine ventricular size, volumes, mass, and ejection fraction.
16095510|NCT02195999|Other|Pulmonary Function Testing (PFT)|It is non-invasive breathing tests that characterize respiratory muscle function, as well as lung compliance and physiology.
16095511|NCT02195999|Other|Metabolic Exercise Testing using stationary bicycle|Metabolic exercise testing, including assessment of exercise capacity and MVO2, evaluates global cardiopulmonary functional status. This is performed with the use of a stationary bicycle.
16095512|NCT02195999|Other|Echocardiogram|The echocardiogram performed with the multiple-echo Dixon method helps to assess participants cross-sectionally and longitudinally for variations and changes in myocardial structure.
16095513|NCT02195986|Drug|Estradiol Vaginal Cream, 0.01%|Estradiol Vaginal Cream, 0.01% (1 x 2g for 7 days)
16095514|NCT02195986|Drug|Estrace® 0.01% cream|Estrace® 0.01% vaginal cream ( 1 x 2g for 7 days)
16095515|NCT02195986|Drug|Placebo Vaginal Cream|Placebo Vaginal Cream ( 1 x 2 g for 7 days)
16095516|NCT02195973|Drug|LDE225|After six cycles of weekly paclitaxel and LDE225, patients with a clinically beneficial response may be continued on weekly paclitaxel alone until disease progression.
16095517|NCT02195960|Dietary Supplement|Placebo|intake corn extract poor in anthocyanins: three daily stick packs containing water-soluble extract from corn cobs poor in anthocyanins
16095518|NCT02195960|Dietary Supplement|intake anthocyanin-rich corn extract|intake anthocyanin-rich corn extract: three daily stick packs containing water-soluble extract from high-anthocyanin rich corn cobs
16095519|NCT02195947|Drug|Growth Hormone|Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration.
16095520|NCT02195934|Other|Standard (blonde) orange juice|Consumption of 500ml standard (blonde) orange juice daily for 28 days
16095521|NCT02195934|Other|Blood orange juice|Consumption of 500ml blood orange juice daily for 28 days
16095522|NCT02195921|Other|single point Zhongwan(CV12) plus antiemetic drug|"All participants were supine in the hospital bed. A disposable sterile acupuncture needle (ø 0.30 × 40 mm, Hwato) was inserted vertically at approximately 20-30 mm until De Qi (sensation of soreness, numbness, distension, etc. around the acupoint) was reported by the participants. Then, the needle handle was clamped via a metal clip to connect to the positive electrode of the electric acupuncture apparatus (Huatuo, SDZ-V model, Suzhou Medical Appliance). Another reference electrode was placed 1 cm above the CV12 acupoints of the stimulation point, where no acupoints or meridians passed through. A dilatational wave at a frequency of 2/10 Hz and a current intensity at the highest level tolerated by the patient, with a maximum intensity no more than 10 mA, were used to deliver the EA stimulation. People in the intervention groups were offered a standardized 30-minute EA session once daily from the 1st day of the four-day chemotherapy cycle."
16095523|NCT02195921|Other|single point Zusanli(ST36) plus antiemetic drug|"A disposable sterile acupuncture needle (ø 0.30 × 40 mm, Hwato) was inserted vertically at approximately 20-30 mm until De Qi (sensation of soreness, numbness, distension, etc. around the acupoint) was reported by the participants. Then, the needle handle was clamped via a metal clip to connect to the positive electrode of the electric acupuncture apparatus (Huatuo, SDZ-V model, Suzhou Medical Appliance). Another reference electrode was placed 1cm below ST36 acupoints of the stimulation point, respectively, where no acupoints or meridians passed through. A dilatational wave at a frequency of 2/10 Hz and a current intensity at the highest level tolerated by the patient, with a maximum intensity no more than 10 mA, were used to deliver the EA stimulation. People in the intervention groups were offered a standardized 30-minute EA session once daily from the 1st day of the four-day chemotherapy cycle."
16095524|NCT02195921|Other|Zusanli(ST36)and Zhongwan(CV12) plus antiemetic drug|Stimulating both Zusanli(ST36)and Zhongwan(CV12)
16095525|NCT02195921|Drug|only antiemetic drug|received routine antiemetic treatment
16095526|NCT02195908|Other|single point Neiguan(PC6) plus antiemetic drug|
16095527|NCT02195908|Other|single point Zhongwan(CV12) plus antiemetic drug|
16095528|NCT02195908|Other|matching points Neiguan(PC6) and Zhongwan(CV12) plus antiemetic drug|
16095529|NCT02195908|Drug|only antiemetic drug|
16095530|NCT02195895|Drug|Alendronate|Weekly oral alendronate 70 mg for 12 months
16095531|NCT02195895|Dietary Supplement|Calcium|Daily oral 1000 mg Calcium
16095532|NCT02195895|Dietary Supplement|Vitamin D|Daily oral 1000 IU
16095533|NCT02195882|Procedure|Exercise program of the scapular muscle stabilizers|
16095534|NCT02195869|Drug|Ibrutinib|
16095535|NCT02195856|Dietary Supplement|Beetroot juice|140mL concentrated Beetroot juice or placebo juice
16095536|NCT02195856|Dietary Supplement|Placebo|
16095537|NCT02195843|Other|Electrical optimization by RVLV Conduction Time with VectSelect|"VectSelect Quartet multivector testing is a programmer-based feature that provides centralized vector testing and programming with the flexibility to select the appropriate pacing vector to meet individual patient needs.
~The Right ventricle - Left Ventricle (RV-LV) conduction time measurement will automatically identify the RV-LV conduction time for each LV electrode ."
16095538|NCT02195843|Other|Anatomical optimization of device and leads|Patients will be implanted with left ventricular leads which will be positioned most basal, most apical or midway in the left ventricle. This follows the physician's routine clinical practice and judgement.
16095539|NCT02195843|Device|Implanted device and lead (Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and SJM Quadripolar lead system)|All participants will be implanted with a St Jude Medical (SJM) Cardiac Resynchronization Therapy Defibrillator (CRT-D) device and SJM Quadripolar lead system. Patients who fulfill the criteria for CRT D implant, will be invited to participate in this clinical investigation. Patients implanted with chronic leads requiring device upgrade to CRT-D can also be enrolled in the study, provided they are receiving a CRT-D device for the first time.
16095540|NCT02195830|Other|Ultrasound of the inferior vena cava|B mode ultrasound of the inferior vena cava Measurements taken 2cm from the hepatic vein IVC junction or 3cm from the right atrium IVC junction
16095541|NCT02195817|Drug|Selincro® 18 mg with continuous psychosocial support: Cohort A|
16095542|NCT02195817|Other|Initial psychosocial support: Cohort B|
16095543|NCT02195804|Drug|Ranitidine hydrochloride ODT|Ranitidine hydrochloride ODT#1 150 mg (Vanilla-Mint)
16095544|NCT02195804|Drug|Ranitidine hydrochloride ODT RM|Ranitidine hydrochloride ODT Reduced Mannitol (RM) 150 mg Vanilla-Mint (ODT#2)
16095545|NCT02195804|Drug|Ranitidine hydrochloride|
16095546|NCT02195791|Drug|Pioglitazone|Pioglitazone 30mg/tab (oral) 1 tab once daily for 7 days
16095547|NCT02195791|Drug|Placebo|Placebo (oral) 1 tab once daily for 7 days
16095548|NCT02195765|Drug|enamel matrix derivative|Open flap debridement associated with enamel matrix derivative
16095549|NCT02195765|Procedure|Open flap debridement|Open flap debridement
16095550|NCT02195752|Other|Compounded Pain Cream|All patients will have been prescribed a topical pain cream prepared by a qualified compounding pharmacy
16095551|NCT02195726|Procedure|Remote ischemic preconditioning|four times 5-minute inflations of a blood pressure cuff to 200 mmHg around the upper non dominant arm (or if systolic pressure is more than 150 mmHg, inflation will reach 50 mmHg up per than baseline), followed by 5-minute intervals of reperfusion.
16095552|NCT02195726|Procedure|Sham remote ischemic preconditioning|In the control group sham preconditioning will be performed with inflation of 10 mmHg more than baseline.
16095553|NCT02195713|Device|Accuryn|Accuryn is a novel electronic urine output monitor
16095554|NCT02195700|Drug|SD-809|SD-809 tablets taken twice daily for 12 weeks, includes a dose titration period and maintenance period.
16095555|NCT02195700|Drug|Placebo|Placebo tablets taken twice daily for 12 weeks.
16095556|NCT02195687|Biological|botulinum toxin Type A|botulinum toxin Type A (BOTOX®) injected into bilateral crow's feet line areas.
16095557|NCT02195687|Drug|Normal Saline|Normal Saline (placebo) injected into bilateral Crow's Feet Line areas.
16095558|NCT02195661|Dietary Supplement|Melatonin|
16095559|NCT02195661|Drug|Chloral Hydrate|
16095560|NCT02195648|Other|Suboccipital inhibition|"Experimental: Suboccipital inhibition
~The intervention group will receive a session of 20 minutes (5 minutes for the patient's reception, 10 for treatment and the following 5 minutes for rest and hemodynamic stabilization), twice a week for 4 weeks. The intervention will consist of suboccipital muscle inhibition and interferential current on the occipital muscles."
16095561|NCT02195635|Drug|Telotristat etiprate|500 mg telotristat etiprate
16095562|NCT02195635|Drug|Octreotide acetate|200 µg octreotide acetate three times daily
16095563|NCT02195622|Device|Lumenis VersaCut Morcellator|
16095564|NCT02195622|Device|Wolf Piranha Morcellator|
16095565|NCT02195609|Dietary Supplement|Omega-3|600 mg oral twice a day
16095566|NCT02195609|Dietary Supplement|Soy Isoflavones|54.4 mg oral twice a day
16095567|NCT02195596|Other|High intensity aerobic exercise+strength|"The program consist in a Continuous High aerobic exercise and moderate intensity intervals (ShoshanaB et al, 2012) combined with muscular strength exercises and joint mobility. Patients come three times a week for six months to the primary health center and will be supervised by an expert nurse."
16095568|NCT02195596|Other|Low intensity aerobic exercise+strength|"Low intensity aerobic exercise+strength program is similar to the other intervention but differs in the intensity of the exercise as it works with intensities below 40% of heart rate reserve.
~--------------------------------------------------------------------------------"
16095569|NCT02195583|Drug|Sodium fluoride (1426 ppm)|Non-zinc, 1426ppm fluoride as sodium fluoride in a silica gel base
16095570|NCT02195583|Drug|Sodium fluoride (1150 ppm)|Non-zinc, 1150ppm fluoride as sodium fluoride in a silica gel base
16095571|NCT02195583|Drug|Sodium fluoride (250 ppm)|Non-zinc, 250ppm fluoride as sodium fluoride in a silica gel base
16095572|NCT02195583|Drug|Sodium fluoride (1426 ppm) + zinc base A|Zinc base A, 1426ppm fluoride as sodium fluoride in a silica gel base
16095573|NCT02195583|Drug|Sodium fluoride (1426 ppm) + zinc base B|Zinc base B, 1426ppm fluoride as sodium fluoride in a silica gel base
16095574|NCT02195583|Drug|Fluoride (0 ppm)|Non-zinc, 0ppm fluoride in a silica gel base
16095575|NCT02195570|Other|Quit Smoking Now (QSN)|"The Quit Smoking Now (QSN) program, offered by the Florida Area Health Education Center, was developed based on principles of the Centers for Disease Control and Prevention's Best Practices for Comprehensive Tobacco Control, and the U.S. Department of Health and Human Services' Treating Tobacco Use and Dependence Clinical Guidelines with an emphasis on reaching medically-underserved populations. The QSN curriculum will be delivered in 6 one-hour sessions . Pregnancy-specific session goals and content cover the effects of smoking on the developing fetus, secondhand smoke exposure, the importance of social support, and postpartum relapse."
16095576|NCT02195570|Behavioral|Prize-based Contingency Management (CM)|Women will earn chances to win prizes for biochemically verified abstinence from tobacco.
16095577|NCT02195557|Drug|Synvisc®|
16095578|NCT02195544|Drug|Synvisc®|
16095579|NCT02195531|Behavioral|Education and feedback|The education leaflets are information concerning Obstructive Sleep Apna (OSA) and CPAP treatment. The feedback reports are CPAP usage patterns.
16095580|NCT02195518|Drug|Tenofovir disoproxil fumarate|Tenofovir disoproxil fumarate tablets supplied will be white, almond-shaped, film-coated tablets containing 300 mg of TDF. Each tablet contains the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, pregelatinised starch, croscarmellose sodium, and magnesium stearate.
16095581|NCT02195492|Drug|Synvisc®|
16095588|NCT02195466|Drug|Tipranavir (TPV)|500 mg bid on days 7-14
16095589|NCT02195466|Drug|Ritonavir (RTV)|200 mg bid on days 7-14
16095590|NCT02195466|Drug|Fluconazole (FCZ)|200 mg loading dose on day 1, followed by 100 mg qd until day 13
16095591|NCT02195453|Drug|Yangzhengxiaoji Capsule|"Gemcitabine 1000mg/m² or Pemetrexed 500mg/m² IV drip on D1 and D8,21 days for a cycle.
~Cisplatin 75mg/m² IV drip for one day or two-three days total injection,21 days for a cycle.
~Yangzhengxiaoji Capsule four granules t.i.d po."
16095592|NCT02195453|Drug|Placebo Capsule|"Gemcitabine 1000mg/m² or Pemetrexed 500mg/m²IV drip on D1 and D8,21 days for a cycle.
~Cisplatin 75mg/m² IV drip for one day or two-three days total injection, 21 days for a cycle.
~Placebo Capsule four granules t.i.d po."
16095593|NCT02195440|Drug|PRI-724|10 - 160 mg/m2, 7 days CIV (in the vein) with 7 days rest per one cycle. Number of Cycles: 6.
16095594|NCT02195427|Device|TEOSYAL® RHA Global Action|"A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 30G1/2 disposable sterile needles."
16095595|NCT02195427|Device|TEOSYAL® RHA Deep Lines|"A sterile, biodegradable, biocompatible, viscoelastic, clear, colorless, homogenized gel implant. It consists of cross-linked hyaluronic acid produced by fermentation of Streptococcus equi bacteria, formulated to a concentration of 23 mg/mL and 0.3% w/w lidocaine in a physiologic buffer. It is supplied in individual treatment syringes with 27G1/2 disposable sterile needles."
16095596|NCT02195414|Device|NeoVas BCS|The NeoVas First-in-Man study is a prospective, two centers, single arm trial, which will enroll a total of 30 patients. The hypothesis of this study is to evaluate clinical feasibility, safety, and efficacy of NeoVas sirolimus-eluting bioresorbable coronary scaffold in the treatment of patients with de novo coronary lesion. The primary endpoint is a composite endpoint of cardiac death, target vessel related myocardial infarction, and ischemia driven target lesion revascularization (TLF) at 1 month follow up. At 6 months, 1, 2, 3, 4 and 5 years follow-up, clinical endpoints include TLF (its individual components), Patient-oriented cardiac event (all cause death, all MI, and all revascularization) target vessel revascularization, scaffold thrombosis.
16095597|NCT02195401|Other|Cleanroom|Cleanroom with air the quality of the pre-industrial age
16095598|NCT02195388|Other|comprehensive cardiac rehabilitation|Standard program of comprehensive cardiac rehabilitation CR with physical activity, behavioral intervention, risk factor modification and intervention.
16095599|NCT02195375|Drug|Flutiform 500/20 µg BID|
16095600|NCT02195375|Drug|Flutiform 250/10 µg BID|
16095601|NCT02195375|Drug|Seretide Accuhaler 50/500 µg BID|
16095602|NCT02195349|Biological|GSK2831781|GSK2831781 (100 milligram (mg)/mL) and its dilutions (Diluent - 0.9 percent saline solution containing 0.015 percent Polysorbate 80) as clear or opalescent, colourless, yellow to brown liquid solution administered by IV over approximately 2 hours.
16095603|NCT02195349|Biological|Placebo|Commercial saline solution administered by IV over approximately 2 hours
16095604|NCT02195336|Device|dMRT|Baseline, day 8, day 28, day 92, progression/relapse.
16095605|NCT02195336|Drug|Bevacizumab|7.5mg/kg every 3 weeks for 3 cycles. Thereafter every 3 weeks until progression/relapse or unacceptable toxicity.
16095606|NCT02195336|Drug|paclitaxel and carboplatin|Standard of care NSCLC first-line chemotherapy Every 3 weeks for 3 cycles. Doublets containing paclitaxel and carboplatin are preferred
16095607|NCT02195323|Biological|Intravenous injection|Intravenous injection of bone marrow derived MSC in patients with CKD.
16095608|NCT02195310|Device|Prevena™ Incision Management System|Prevena™ Incision Management System is used after sternotomy on the closed incision
16095609|NCT02195310|Device|Conventional sterile wound dressings|Conventional sterile wound dressings are placed after sternotomy on the closed incision
16095610|NCT02195297|Other|ANTICELLULITE GMG GIULIANI Cream and SOMATOLINE Cream|Products application: mono-laterally, once a day at evening (4 doses from each dispenser for the first 2 day-treatment and 2 doses for the following days)
16095611|NCT02195284|Device|ELLIPTA|Dry powder inhaler (placebo) with two blister strips. One placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate
16095612|NCT02195284|Device|DISKUS/ACCUHALER|Placebo inhaler with one blister strip containing lactose monohydrate.
16095613|NCT02195284|Device|MDI|Placebo inhaler containing propellant (1,1,1, 2-Tetrafluoroethane)
16095614|NCT02195284|Device|TURBUHALER|Placebo inhaler containing lactose monohydrate.
16095615|NCT02195271|Device|Transcranial Direct Current Stimulation (tDCS)|
16095616|NCT02195271|Drug|Melatonin|
16095617|NCT02195245|Device|memsorb|
16095618|NCT02195232|Drug|Isoquercetin|
16095619|NCT02195219|Procedure|open reduction internal fixation|MINAR device allows for reduction of the acromioclavicular joint and the reconstruction of coracoclavicular ligaments with a suture cerclage system. Three weeks after surgery a rehabilitation program will be carried out.
16095620|NCT02195219|Other|sling rest and early functional recovery|Immobilization with a sling for three weeks and, from this time, the same rehabilitation program will be performed.
16095621|NCT02195193|Other|Integrated care|an integrated care model for ACS and depression delivered by a collaborative team composed of cardiologists/internists and nurses in the same rural county hospital. The collaborative team will be able to provide medical services for the diagnosis and treatment at acute phase of ACS during hospitalization, ACS secondary prevention therapies at and after discharge, and screening and treatment of depression depressive symptom during hospitalization and after discharge. The core of the interventions includes: depressidepressive symptomon screening and classification, individual counseling and medical treatment of depression, group counseling and health education, and follow-up for ACS and depression treatments compliance, IT- system- assisting theassisted management and necessary referral.
16095622|NCT02195180|Drug|ERY001|
16095623|NCT02195180|Drug|Gemcitabine|
16095624|NCT02195180|Drug|5-fluoro-uracil/oxaliplatin/leucovorin (folfox)|oxaliplatin 85 mg/m2 levo-leucovorin 200 mg/m2 5-FU 400 mg/m2
16095625|NCT02195167|Drug|Dasotraline 1 mg, 2 mg, 4 mg, 8 mg, 12 mg, 16 mg, 20 mg, 24 mg, 28 mg, 32 mg once daily|"Dasotraline 1 mg, 2 mg, 4 mg, 8 mg, 12 mg, 16 mg, 20 mg, 24 mg, 28 mg, 32 mg once daily. The planned dose for the first cohort is 1mg. There will be no more than a 2-fold increase in dose increase in dose between consecutive dose cohorts up to 8 mg, and dose cohorts beyond the 8 mg level will increment no more than 4mg. The maximum dose will not exceed 32mg. The language should precede the text that is currently there"
16095626|NCT02195154|Drug|18F-DTBZ|"During this study, subjects will receive a single i.v. administration of approximately 10 mCi 18F-FP-(+)-DTBZ immediately prior to imaging. The compound is labeled with fluorine 18F that decays by positron (β+) emission and has a half life of 109.7 min. The principal photons useful for diagnostic imaging are the 511 keV gamma photons, resulting from the interaction of the emitted positron with an electron.
~The proposed dose for this study is based on the phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG."
16095627|NCT02195141|Radiation|conventional fraction|capecitabine 825mg/m2 p.o. twice daily Radiotherapy 50Gy/25f
16095628|NCT02195141|Radiation|SIB|Concomitant chemoradiotherapy Radiotherapy with boost Radiotherapy (25 x 2 Gy), with a simultaneous integrated boost up to 56 Gy on the primary tumor capecitabine 825mg/m2 p.o. twice daily
16095629|NCT02195115|Procedure|Laparoscopic Cholecystectomy|
16095630|NCT02195115|Drug|amitriptyline|
16095631|NCT02195115|Other|low-fat and low cholesterol diet|
16095632|NCT02195102|Device|Transcatheter aortic valve Replacement|
16095633|NCT02195089|Drug|BLS_ILS_E710c 500mg|- 2 capsules per day for 20 days (week 1,2,4 & 8)
16095634|NCT02195089|Drug|BLS_ILB_710c 1000mg|- 4 capsules per day for 20 days (week 1,2,4 & 8)
16095636|NCT02195076|Other|non-invasive detection of cancer odor|The odor VOCs of the specimens will be subjected to our system for detection by the biosensors. If the sample is cancerous the biosensors will report it (YES signal). If the sample s not cancerous, the biosensors will not report it (NO signal).
16095637|NCT02195024|Procedure|cardiac MRI group|• All subjects of the MRI group will undergo a predefined series of magnetic resonance heart scans ≥ six (6) weeks after device exchange
16095638|NCT02195011|Device|SIR-Spheres|Radioembolization will be administered once by injection through a trans-femoral catheter into the hepatic artery.
16095639|NCT02195011|Drug|Regorafenib|All patients will take regorafenib 160mg orally once daily on Days 1-21 of each 28-day cycle.
16095640|NCT02194998|Drug|Paritaprevir/ritonavir/ombitasvir (PTV/r/OBT)|PTV/r/OBT: 150/100/25 mg (two 75/50/12.5 mg fixed-dose combination tablets) orally once a day
16095641|NCT02194998|Drug|Dasabuvir (DSV)|DSV: 250 mg orally twice a day
16095642|NCT02194998|Drug|Ribavirin (RBV)|RBV: 1,000 or 1,200 mg (weight-based) dosed in two divided doses orally twice a day (all participants (version 1); only participants with HCV genotype 1a (version2))
16095643|NCT02194985|Drug|migalastat HCl 150 mg|Migalastat HCl 150 mg (equivalent to 123 mg migalastat) was provided as capsules in blister packs. One capsule was taken orally every other day.
16095644|NCT02194972|Drug|Pectin|pectin （Andeli Ltd. Yantai, China）, 24g/d for 4weeks
16095645|NCT02194959|Behavioral|Peer PN|Navigation by Peer Patient Navigators
16095646|NCT02194959|Behavioral|Pro PN|Navigation by Standard Hospital Navigators
16095647|NCT02194946|Drug|CM therapies|The choice of CM patterns will be at the treating physician's discretion. The dosing regimen of Chinese herbs and Chinese patent medicine will be as per the 2010 Chinese pharmacopoeia.The oral Chinese herbal formula will be composed of 18 herbs:Radix Astragali, Radix Codonopsis, Rhizoma Atractylodis Macrocephalae, Rhizoma diosscoreae, Poria, Semen Cuscutae, Radix Morindae Officinalis, Herba Epimedii, Herba Cistanches, Fructus Ligustri Lucidi, Rhizoma Polygonati, Fructus Amomi, Herba Agastaches, Rhizoma Coptidis, Radix et Rhizoma Rhei, Semen Coicis, Radix Salviae Miltiorrhizae, and stir-baked Semen Persicae. The Chinese herbal formula via Colonic administration will be composed of 3 herbs: Radix et Rhizoma Rhei, Calcined Concha Osterae, Herba Taraxaci.
16095648|NCT02194946|Drug|CKD-related management|Western medicine treatment for CKD are practised following KDIGO and KDOQI guidelines, to reach the recommended goals of nutrition, blood pressure, hemoglobulin, electrolytes, fluid control and acid-base balance.
16095649|NCT02194933|Drug|Brexpiprazole|Brexpiprazole 2 mg/day, once daily dose, tablet, orally, for 6 weeks - Brexpiprazole 4 mg/day, once daily dose, tablet, orally, for 6 weeks
16095650|NCT02194920|Procedure|Thyroidectomy and parathyroid reimplantation in forearm subcutaneous tissue|
16095651|NCT02194907|Behavioral|Brain activity training - anterior insula|training sessions using a special feedback technique to learn to actively increase blood flow in the front of the brain
16095652|NCT02194907|Behavioral|Brain activity training - medial prefrontal cortex|training sessions using a special feedback technique to learn to actively increase blood flow in the back of the brain
16095653|NCT02194894|Drug|Acetaminophen|acetaminophen will be given for patient for both arms for 14 days
16095654|NCT02194881|Drug|CF patients with a G551D mutation and treated with Ivacaftor|
16095655|NCT02194868|Biological|Recipients|"Adult recipient:
~collected 20 ml pre-transplant
~collected 30 ml for adults on day 20 post-transplant at engraftment for cell phenotype,
~collected 30 ml on days 30, 60, 90, 180, 360 days post-HSCT for cell phenotyping at all time points, functional INKT at day 60 or 90 depending on the number of cells collected and anti-viral ELISPOT studies on days 180 and 360
~Children recipients
~collected residual blood pre-transplant
~collected residual blood on day 20 post-transplant at engraftment for cell phenotype,
~collected residual blood on days 20, 30, 90, 180 and 360 post-HSCT"
16095656|NCT02194868|Biological|Donors|"Adult donors :
~collected 20 ml of blood, (if possible before granulocyte colony-stimulating factor (GCSF) administration)
~collected 1 ml of the stem cell graft for adult recipient or 2 ml of bone marrow for children recipients These samples will be collected at the same time of those needed for transplant.
~Children donors samples
~collected residual blood
~2ml of bone marrow (bottom of tube)"
16095657|NCT02194855|Drug|rocuronium|Rocuronium 0.6 mg.kg-1 was administered within 5 s as an intravenous bolus
16095658|NCT02194855|Drug|cisatracurium|cisatracurium 0.15mg.kg-1 was administered within 5 s as an intravenous bolus
16095659|NCT02194842|Drug|Ra223|
16095660|NCT02194842|Drug|Enzalutamide|
16095661|NCT02194829|Drug|Adavosertib|Given PO
16095662|NCT02194829|Drug|Gemcitabine Hydrochloride|Given IV
16095663|NCT02194829|Other|Laboratory Biomarker Analysis|Correlative studies
16095664|NCT02194829|Drug|Nab-paclitaxel|Given IV
16095665|NCT02194829|Other|Pharmacological Study|Correlative studies
16095666|NCT02194829|Other|Placebo Administration|Given PO
16095667|NCT02194790|Behavioral|Community-based Integrated CKD Care|Patients received, in addition to the standard care, educational activities provided by nutritionist, pharmacist and physiotherapist, and quarterly home visits. Our home visits team consisted of nurse, health care officers and village health volunteers
16095668|NCT02194777|Drug|BIBN 4096 BS - in single rising doses|
16095669|NCT02194777|Drug|Placebo|
16095670|NCT02194764|Drug|Naltrexone and 2-butanol|50mg of Naltrexone and 40 or 80 mg of 2-butanol (depending on Stability Formulation in the first part of the study)
16095671|NCT02194764|Drug|2-butanol which is encapsulated (size 3 capsule) plus 50 mg of naltrexone (HCl form)|a capsule-in-capsule (CIC) design, will be prepared in the pharmacy by incorporating 40 or 80 mg (determined from the first part of the study) of 2-butanol which is encapsulated (size 3 capsule) plus 50 mg of naltrexone (HCl form) in a size 0 double blind hard gel capsule.
16095672|NCT02194751|Biological|Oncoquest-L vaccine|Patients will receive a total of 5 single administrations of Oncoquest-L; the first 2 doses administered will be separated by a 2-week interval and the remaining 3 doses will be administered each at 1-month intervals. With each dose of Oncoquest-L vaccine, the vaccine will be administered subcutaneously at 2 different sites in the upper arms or upper legs, with alternation of the injection sites with each administration. For each vaccination, a total of 1.0 mL of vaccine will be administered, divided into 2 subcutaneous injections of 0.5 mL each at 2 different injection sites.
16095686|NCT02194712|Other|Urine CAA detection|In addition to routine diagnostics, serum and urine samples are stored for retrospective UCP-CAA antigen determination.
16095687|NCT02194699|Biological|Experimental: Tralokinumab|Tralokinumab subcutaneous injection
16095688|NCT02194699|Other|Placebo|Placebo subcutaneous injection
16095689|NCT02194686|Drug|Cilostazol|One tablet (100 mg) twice per day for 12 weeks
16095690|NCT02194686|Drug|Dummy Placebo|One tablet twice per day for 12 weeks
16095691|NCT02194673|Other|Trans free palm margarine|A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.
16095692|NCT02194673|Other|Interesterified Palm based margarine|A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.
16095693|NCT02194673|Other|IE Soybean oil-based margarine|A randomised, double-blind crossover (3 × 3 arms) orthogonal Latin-square design was used and conducted on 10 males and 10 females adults.
16095694|NCT02194634|Drug|Conbercept|Intravitreal injection of 0.5 mg Conbercept at first month, then repeated as needed.
16095695|NCT02194634|Other|Sham injection|Sham intravitreal injection at first month, then repeated as needed.
16095696|NCT02194634|Procedure|Laser|Laser treatment at first month, then repeated as needed.
16095697|NCT02194634|Other|Sham laser|Sham laser at first month, then repeated as needed.
16095698|NCT02194621|Drug|Total Flavor option 1|Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1
16095699|NCT02194621|Drug|Total Flavor option 2|Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2
16095700|NCT02194621|Drug|Placebo toothpaste: Crest Cavity Protection toothpaste|Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)
16095701|NCT02194608|Device|Home telehealth system|Participants will receive a weighing machine, glucometer, and a sphygmomanometer connected through a Bluetooth system from their home to the Telehealth center via a HUB.
16095702|NCT02194595|Drug|Basal insulin and exenatide|
16095703|NCT02194595|Drug|Basal insulin only|
16095704|NCT02194595|Drug|Basal insulin and bolus insulin|
16095705|NCT02194569|Drug|Citrate|
16095706|NCT02194556|Drug|Sequential and maintenance icotinib|Patients are administered with sequential and maintenance icotinib plus chemotherapy. Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1, sequential icotinib 125 mg is administered orally three times per day at d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive maintenance icotinib until disease progression or intolerable toxicity.
16095707|NCT02194556|Drug|Maintenance icotinib|Gemcitabine 1000mg/m2 iv d1 and d8, cisplatin 75mg/m2 iv d1. After receiving a maximum of 4-cycle treatment, non-progressive patients continue to receive maintenance icotinib (125 mg three times per day) until disease progression or intolerable toxicity.
16095708|NCT02194517|Device|ELKa|ELKa should be used for every meal preparation. After choosing the name of particular product from the list, the program will give precise information about the amount of CHO and FP exchanges in serving. No standard calculation of exchanges need to be performed.
16095709|NCT02194504|Other|Dietary advice, Western|Dietary advice, guided by professional dieticians. Caloric restricted (-30en%) diet with Western type nutrient composition (SFA, carbohydrates, sugars, fruit juice, meat, dairy)
16095710|NCT02194504|Other|Dietary advice, Targeted|Dietary advice, guided by professional dieticians. Caloric restricted (-30en%) diet with nutrient composition aiming at an improvement in organ health and a reduction in liver fat (PUFA, fish, soy protein, whole grain)
16095711|NCT02194491|Other|[11C]AS2471907|intravenous radiotracer
16095712|NCT02194491|Radiation|Positron Emission Tomography (PET)|Imaging scanning procedure
16095713|NCT02194491|Drug|ASP3662|oral
16095714|NCT02194478|Behavioral|Meditation|30 minute, 8 week meditation
16095715|NCT02194465|Drug|LY2623091|Administered orally
16095716|NCT02194465|Drug|Tadalafil|Administered orally
16095717|NCT02194465|Drug|Spironolactone|Administered orally
16095718|NCT02194465|Drug|Placebo|Administered orally
16095719|NCT02194452|Radiation|gallium Ga 68-edotreotide|Undergo gallium Ga 68-edotreotide PET/CT
16095720|NCT02194452|Procedure|positron emission tomography|Undergo gallium Ga 68-edotreotide PET/CT
16095721|NCT02194452|Procedure|computed tomography|Undergo gallium Ga 68-edotreotide PET/CT
16095722|NCT02194452|Other|laboratory biomarker analysis|Correlative studies
16095723|NCT02194426|Drug|MP0250|Intravenous application by infusion of MP0250 at up to six dose levels, every other week for up to 24 infusions.
16095724|NCT02194413|Procedure|therapeutic touch|receiving healing touch
16095725|NCT02194413|Other|quality-of-life assessment|Ancillary studies
16095726|NCT02194413|Other|questionnaire administration|Ancillary studies
16095727|NCT02194400|Biological|RSLV-132|0.3 - 10.0 mg/kg RSLV-132 weekly for 4 weeks
16095728|NCT02194387|Dietary Supplement|Dietary Intervention|Record dietary intake 4-7 days per week
16095729|NCT02194387|Dietary Supplement|Dietary Intervention|Record dietary intake 1 day per week
16095730|NCT02194387|Other|Internet-Based Intervention|Receive email coaching
16095731|NCT02194387|Other|Internet-Based Intervention|Participate in social networking
16095732|NCT02194387|Other|Laboratory Biomarker Analysis|Correlative studies
16095733|NCT02194387|Other|Questionnaire Administration|Ancillary studies
16095734|NCT02194387|Behavioral|Telephone-Based Intervention|Receive telephone coaching
16095735|NCT02194387|Behavioral|Telephone-Based Intervention|Receive text messages
16095802|NCT02194023|Drug|0.12%NF|Participants were asked to rinse every 12 hours, with 15 ml for 30 seconds, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes.
16095736|NCT02194374|Procedure|ROR1R-CAR-T Cell Infusion|"Dose Escalation Cohort starting dose level of ROR1R-CAR-T cells/kg: 105 cell/kg infused via central venous catheter or by vein on Day 1.
~Dose Expansion Cohort starting dose level of ROR1R-CAR-T cells/kg: MTD from Dose Escalation Cohort."
16095737|NCT02194374|Drug|Fludarabine|"FCR Regimen: 25 mg/m2 by vein on Days -5, -4, and -3.
~FBR Regimen: 20 mg/m2 by vein Days -5, -4, and -3."
16095738|NCT02194374|Drug|Cyclophosphamide|FCR Regimen : 250 mg/m2 by vein on Days -5, -4, and -3.
16095739|NCT02194374|Drug|Rituximab|"FCR and FBR Regimen: 375-500 mg/m2 by vein on Day -5.
~BR Regimen: 375-500 mg/m2 by vein on Day -4."
16095740|NCT02194374|Drug|Bendamustine|"BR Regimen: 70-90 mg/m2 by vein on Days -4 and -3.
~FBR Regimen: 30-50 mg/m2 by vein on Days -5 to -3."
16095741|NCT02194361|Drug|Anthocyan capsules|Bilberry extract capsules, 160 mg (25% anthocyanosides)
16095742|NCT02194361|Drug|Placebo|
16095743|NCT02194348|Drug|BIBN 4096 BS - in single rising doses|
16095744|NCT02194348|Drug|Placebo|
16095745|NCT02194335|Drug|BIBN 4096 BS - in single rising doses|
16095746|NCT02194335|Drug|Placebo|
16095747|NCT02194322|Drug|BIBN 4096 BS - in single rising doses|
16095748|NCT02194322|Drug|Placebo|
16095749|NCT02194309|Drug|Telmisartan low|
16095750|NCT02194309|Drug|Telmisartan high|
16095751|NCT02194309|Drug|amlodipine|
16095752|NCT02194296|Drug|Ambroxol hydrochloride - lozenge|
16095753|NCT02194296|Drug|Ambroxol hydrochloride - syrup|
16095754|NCT02194283|Drug|Ambroxol - in single rising doses|
16095755|NCT02194283|Drug|Placebo|
16095756|NCT02194270|Drug|Ambroxol hydrochloride - soft pastille|
16095757|NCT02194270|Drug|Ambroxol hydrochloride - syrup - low dose|
16095758|NCT02194270|Drug|Ambroxol hydrochloride - syrup - high dose|
16095759|NCT02194257|Drug|[14C]-cyclohexane ambroxol oral solution|
16095760|NCT02194257|Drug|[14C]-benzyl ambroxol oral solution|
16095761|NCT02194257|Drug|Ambroxol lozenge|
16095762|NCT02194244|Drug|RG1662 granules|Single dose, oral administration of RG1662 immediate release granules
16095763|NCT02194244|Drug|RG1662 tablet|Single dose, oral administration of film-coated RG1662 immediate release tablet
16095764|NCT02194231|Drug|Trabectedin|Patients will receive 1.1 mg/m2 intravenous trabectedin infusion in 5% glucose via central venous catheter over 3 hours every 21 days. Trabectedin infusion will be preceded by 20 mg of intravenous dexamethasone
16095765|NCT02194218|Drug|Nevirapine, low dose|50 mg
16095766|NCT02194218|Drug|Nevirapine, high dose|100 mg
16095767|NCT02194205|Drug|COMBIVENT HFA|
16095768|NCT02194205|Drug|Placebo HFA|
16095769|NCT02194205|Drug|COMBIVENT CFC|
16095770|NCT02194205|Drug|Placebo CFC|
16095771|NCT02194192|Drug|Placebo|Normal saline 10 ml
16095772|NCT02194192|Drug|Ondansetron|Ondasetron 8 mg IV after spinal anesthesia
16095773|NCT02194192|Drug|Ephedrine|Ephedrine 10 mg IV after spinal anesthesia
16095774|NCT02194179|Drug|NVP XR 400 mg (KCR 25%)|
16095775|NCT02194179|Drug|NVP XR 400 mg (KCR 20%)|
16095776|NCT02194179|Drug|NVP XR 300 mg (KCR 25%)|
16095777|NCT02194179|Drug|NVP XR 300 mg (KCR 20%)|
16095778|NCT02194179|Other|high-fat breakfast|
16095779|NCT02194179|Drug|NVP IR 200 mg (Viramune®)|
16095780|NCT02194166|Drug|Trastuzumab|Trastuzumab IV or SC will be administered as described.
16095781|NCT02194166|Drug|Paclitaxel|Paclitaxel will be administered in accordance with local hospital practice.
16095782|NCT02194166|Drug|Docetaxel|Docetaxel will be administered in accordance with local hospital practice.
16095783|NCT02194153|Drug|Metalyse weight-adjusted|
16095784|NCT02194140|Other|oral iodinated contrast material|diluted in water
16095785|NCT02194127|Drug|Anthocyan capsules|
16095786|NCT02194127|Drug|Placebo|
16095787|NCT02194114|Other|Protein Diet|Protein diets fed for 17-19 days to each patient in random order: 0.6 g protein/kg/day, 0.8 g protein/kg/day, 1.0 g protein/kg/day, 1.15 g protein/kg/day, 1.3 g protein/kg/day.
16095788|NCT02194101|Procedure|Supernormal oxygen delivery goal therapy|A 10% increase in stroke volume (SV) after fluid challenge (5 ml/kg) with Ringer's lactate solution will be deemed positive. Oxygen delivery will be check when fluid challenge becomes negative. If oxygen delivery index (DO2I) can not be greater than 600 mL/m2, then dobutamine will be started at a dose of 2.5 μg/kg/min and increased by the same increment every 20 minutes until the described target is reached or until a maximal dose of 10 μg/kg/min is given. Dobutamine is decreased in dose or discontinued if the heart rate is above 100 beats per minute or shows signs of cardiac ischemia. Blood transfusions will be used to maintain a hemoglobin concentration over 8mg/dL.
16095789|NCT02194088|Drug|Diclofenac and Atropine combination drug|Diclofenac will be associated with a small dose of atropine 1.2mg
16095790|NCT02194088|Drug|Placebo|For each capsule of active medication, a capsule of placebo will be provided, identical looking.
16095791|NCT02194075|Drug|Fluvoxamine+Methylphenidate hydrochloride|
16095792|NCT02194075|Drug|Fluvoxamine+sugar pill|
16095793|NCT02194062|Drug|fluticasone nasal spray|use 2-50 mcg sprays to each nostril two times per day
16095794|NCT02194062|Drug|Budesonide head upright|(0.5 mg/2mL) to instill into each nostril in the upright position two times per day
16095795|NCT02194062|Drug|Budesonide head forward|(0.5 mg/2mL) to instill into each nostril in the head forward position two times per day
16095796|NCT02194049|Drug|BKM120|Given PO
16095797|NCT02194049|Drug|cisplatin|Given IV
16095798|NCT02194049|Drug|etoposide|Given IV
16095799|NCT02194036|Behavioral|Learning Oriented Physiotherapy|Clinical practice based on a new understanding of the neurobiological basis for the interaction between body and mind, the foundation of learning and what is needed to bring about change of behavior.
16095800|NCT02194036|Behavioral|Widely Recognized Psychiatric Treatment|Standard recognized psychiatric treatment tailored to individual needs.
16095801|NCT02194023|Drug|Placebo: PCB|Participants were asked to rinse every 12 hours, with 15 ml for 30 seconds, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes.
16095931|NCT02193087|Drug|TDV Liquid Formulation 2|TDV Liquid Formulation 2 for subcutaneous injection
16095803|NCT02194023|Drug|0.03%NF|Participants were asked to rinse every 12 hours, with 15 ml for 30 seconds, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes.
16095804|NCT02194023|Drug|PAT|Patients were asked to rinse every 12 hours, and after spitting to refrain from rinsing their mouths with water and from eating or drinking for at least 60 minutes.
16095805|NCT02193997|Other|Fiber|
16095806|NCT02193997|Other|Fiber|
16095807|NCT02193997|Other|Placebo|
16095808|NCT02193984|Behavioral|Peer support|
16095809|NCT02193971|Device|BS-DES (Biostable polymer drug-eluting stent)|
16095810|NCT02193971|Device|BD-DES (Biodegradable polymer drug-eluting stent)|
16095811|NCT02193971|Drug|Prasugrel 5mg|Use prasugrel 5mg daily for maintaning dose
16095812|NCT02193958|Drug|FF-10501-01|FF-10501-01 will be administered orally on Days 1-14 of a 28-day cycle. The dose-escalation will proceed until Maximum Tolerated Dose (MTD) is reached. The treatment will continue until disease progression, intolerable toxicity or investigation/subject decision.
16095813|NCT02193932|Other|EEG Triggered fMRI using Micro Maglink|
16095814|NCT02193906|Other|Cognitive training|Every patient will have 3 neuropsychological evaluations (with the same battery): baseline, after a 3-month period of training and 6 months after the conclusion of the training. Patients who have computer with internet access at home will perform a minimum of 3 sessions per week of Cogweb® during 3 months. Patients who don't have computer with internet access at home will perform a minimum of 3 sessions per week of Cogweb Monthly Notebooks® during 3 months. Every patient included will have an outpatient appointment in the end of the first and second months of training.
16095815|NCT02193906|Other|Placebo task|Every patient will have 3 neuropsychological evaluations (with the same battery): baseline, after a 3-month period of training and 6 months after the conclusion of the training. Patients will have to complete a placebo task (send an email with a copy of a journal/magazine heading) a minimum of 3 times a week, for 3 months. Every patient included will have an outpatient appointment in the end of the first and second months of training.
16095816|NCT02193893|Other|Biological: Cell-based therapeutics|Human autologous bone marrow-derived stem/progenitor cell transplantation in ALS patients.
16095817|NCT02193893|Other|Symptomatic treatment of ALS|Symptomatic neurological treatment of ALS
16095818|NCT02193880|Device|Alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.|Post-transplant alpha-beta depleted T-cell infusion after post-transplant cyclophosphamide.
16095819|NCT02193867|Drug|Sebelipase Alfa|Sebelipase alfa is a recombinant human lysosomal acid lipase. The investigational medicinal product is an enzyme replacement therapy intended for treatment of participants with LAL-D. Dosing occurred once weekly for up to 3 years.
16095820|NCT02193854|Device|Mobile Phone|Investigators used Sana system, that is a mobile phone-based, open source software platform for telemedicine services. The Android-based system supports multimedia, location-based data, and text. In the village health clinic, a healthcare worker will interact with a patient and collects data through a step-by-step clinical questionnaire on a smart mobile phone. As patients' data is uploaded to an open source electronic medical record system (OpenMRS) with a diagnosis-specific information and images. The consultant can access the clinical information about the patient and make appropriate diagnoses and treatment recommendations from the secondary hospital.
16095821|NCT02193841|Procedure|Curettage with puncture (C & P)|A curette will be inserted to scrape the contents of the cyst (curettage) and a hole in the cyst wall will be made (puncture) near the bone marrow cavity
16095822|NCT02193841|Device|Curette|A small surgical instrument with a rounded edge designed for scraping
16095823|NCT02193841|Device|Vitoss morsels|A bone substitute intended for use as a filler for voids or gaps in bones
16095824|NCT02193828|Biological|Collagenase clostridium histolyticum|Single injection into nodule
16095825|NCT02193828|Biological|Placebo|Single injection into nodule
16095826|NCT02193815|Drug|PF06263276|4% PF 06263276 solution Daily dosage: approximately 8 mg PF 06263276 QD
16095827|NCT02193815|Other|Vehicle|Active ingredient-free vehicle to 4% solution
16095828|NCT02193815|Drug|2%Tofacitinib Ointment|Daily Dosage: approximately 4 mg tofacitinib
16095829|NCT02193815|Other|Vehicle|Active ingredient-free vehicle to 2% Ointment
16095830|NCT02193815|Drug|Daivonex|Daivonex solution (50 ug/ml Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg
16095831|NCT02193815|Drug|Daivonex Ointment|Daivonex ointment (50 ug/g Calcipotriol) Daily Dosage of calcipotriol: approximately 0.01 mg
16095832|NCT02193802|Device|PillCam® COLON 2 and PillCam Crohn's capsules|"Patient preparation for PillCam® COLON 2 and PillCam Crohn's capsule procedure:
~Patients will drink only clear liquids beginning 12 noon the day prior to the procedure,12 hour fast prior to the procedure and 1 L of PEG on the morning two hours before the capsule ingestion.
~Patients can drink clear liquids 2 hours and eat 4 hours post ingestion. Eight hours post ingestion the data recorder should be removed. Patients will confirm excretion of the capsule or as required by the investigator."
16095833|NCT02193789|Procedure|deployment of through the scope covered metallic stent at the stricture site|Deployment of Covered Self-expandable Metallic Stents Insertion fixing with Clips and Suture Material at the stricture site
16095834|NCT02193789|Device|Covered Self-expandable Metallic Stents|
16095835|NCT02193776|Drug|PA-824|oral
16095836|NCT02193776|Drug|bedaquiline|oral
16095837|NCT02193776|Drug|moxifloxacin|oral
16095838|NCT02193776|Drug|pyrazinamide|oral
16095839|NCT02193776|Drug|isoniazid, rifampicin, pyrazinamide and ethambutol combination tablet|oral
16095840|NCT02193763|Procedure|Ultrasound assisted lumbar puncture|An investigator will perform beside ultrasound on the spinal area using a bedside ultrasound device. Attempts will be made to visualize the spinous processes and vertebral bodies in the general lumbarsacral area, as well as the presence of CSF in the thecal space below the conus medullaris, and identify the optimal location to perform the LP. This will be marked with a skin marker (If no CSF or abnormal anatomy is visualized, the LP will be advised to be postponed or cancelled). The treating physician will then proceed with the LP guided by the skin markings.
16095841|NCT02193750|Dietary Supplement|Placebo|1 placebo muesli bar and 1 serving placebo muesli per day (0.55 g total fructans/GOS)
16095842|NCT02193750|Dietary Supplement|Moderate Oligosaccharide Group|1 placebo muesli bar and 1 serving intervention muesli per day (3.25 g total fructans/GOS)
16095843|NCT02193750|Dietary Supplement|High Oligosaccharide Group|1 placebo muesli bar and 1 serving placebo muesli per day (5.43 g total fructans/GOS)
16095844|NCT02193737|Procedure|Early oral fluid recovery.|
16095845|NCT02193737|Procedure|Delayed oral fluid recovery.|
16095846|NCT02193724|Other|Skin Biopsy|A very small skin sample will be taken from the participant's arm. This will only be performed while the patient is under sedation for clinical purposes (e.g. exam under anesthesia, MRI, or other procedure requiring sedation).
16095847|NCT02193724|Other|Blood Draw|About 1 teaspoon of blood will be drawn from the participant's arm or from a central line catheter if present. Blood collection will be done at the same time the participant has blood drawn for routine clinical care.
16095848|NCT02193711|Other|Topical Arthritis Cream|
16095849|NCT02193698|Drug|Lenalidomide+Dexamethasone|Lenalidomide 25mg/day (day 1-21) Dexamethasone 20mg/day (day 2. 9, 16, 23)
16095850|NCT02193672|Drug|[18F] Fluciclatide|[18F] Fluciclatide given by vein before PET/CT scan.
16095851|NCT02193672|Procedure|PET/CT Scan|PET/CT scan performed at treatment baseline visit, and about 1 week before first cycle of chemotherapy. Then, a PET/CT scan performed at end of first cycle of chemotherapy.
16095852|NCT02193672|Behavioral|Phone Calls|Phone call to participants by study staff about 24 hours after each PET/CT is performed.
16095853|NCT02193659|Dietary Supplement|Cereals|The participants were randomly single blind controlled trial distributed into three groups: (1, n =38), (2, n =38), (3, n =37). For 30 days, participants in group 1 took cereals with omega-3 in the breakfast with diet, group 2 took cereals and diet, and group 3 only received the diet.
16095854|NCT02193633|Drug|AZD2014 3 on/4 off & weekly paclitaxel|AZD2014 3 days on, 4 days off + weekly paclitaxel
16095855|NCT02193633|Drug|AZD2014 2 on/5 off & weekly paclitaxel|AZD2014 2 days on, 5 Days off + weekly paclitaxel
16095856|NCT02193620|Drug|PHN131 soft capsule with Nalbuphine HCl 60 mg/cap|Multiple dose of oral PHN131 soft capsule with Nalbuphine HCl 60 mg/cap, initial dose : 120 mg ( 2 capsules), then 60 mg (1 capsule); t.i.d.
16095857|NCT02193620|Drug|Placebo soft capsules|Multiple dose of oral Placebo soft capsules, initial dose: 2 capsules, then 1 capsule; t.i.d.
16095858|NCT02193620|Drug|Dicofenac|All subjects will receive diclofenac by IM injection for analgesia as rescue pain control.
16095859|NCT02193607|Procedure|TVT-O|Artificial mesh belt is placed in the middle urethra to provide support to remain no leak
16095860|NCT02193607|Procedure|Improved reconstruction pelvic surgery|Repair of severe pelvic organ prolapse with mesh.
16095861|NCT02193594|Radiation|Preoperative concurrent chemoradiotherapy|The patients will receive radiotherapy in the total amount of 50Gy(25 fractions) preoperatively,concurrently combined with chemotherapy,which consist of oxaliplatin 40mg/m2 administrated on days 1,8,15,22,29 and S-1® 30mg/m2 twice per day on days 1 to 5 per week.
16095862|NCT02193594|Procedure|Radical D2 total gastrectomy|Within 5-6 weeks after the completion of neoadjuvant therapy,the patients in CCRT group will receive the radical total gastrectomy with D2 lymphadenectomy,and patients in the CT group will receive the surgery right after randomization.
16095863|NCT02193594|Drug|Adjuvant chemotherapy|Within 2 months after surgery,the patients will receive chemotherapy for 6 to 8 cycles ,consist of oxaliplatin 130mg/m2 administrated on day1 and S-1® 40-60mg twice per day on days 1 to 14 per 3 weeks.The S-1® dosage depends on the patient BSA(BSA<1.25m2 40mg,1.25 m2≤BSA≤1.5 m2 50mg ,BSA>1.5 m2 60mg). Patients in the CCRT group will receive 6 cycles of chemotherapy and patients in the CT group will receive 8 cycles of chemotherapy.
16095864|NCT02193581|Device|MDS|Patients with a suspicious lesion, referred for a biopsy is tested using MDS.
16095865|NCT02193568|Procedure|Arm I (light sedation)|If patients experience excessive preoperative anxiety they will receive light sedation of midazolam 1 mg IV.In our standard practice, it is very rare that patients receive anxiolytic premedication for craniotomies, so it is unlikely that many will require midazolam. Two IVs will be placed, one for infusion of meds and one for possible resuscitation.
16095866|NCT02193568|Procedure|Arm II (intubated general anesthesia)|Receive intubated general anesthesia
16095867|NCT02193568|Procedure|Arm II (intubated general anesthesia)|Undergo craniotomy
16095868|NCT02193568|Other|Arm II (intubated general anesthesia)|Ancillary studies
16095869|NCT02193568|Procedure|Arm I (light sedation)|Undergo craniotomy
16095870|NCT02193568|Other|Arm I (light sedation)|Ancillary studies
16095871|NCT02193555|Device|Etafilcon A, Senofilcon A|1 pair of either test or control lenses will be fitted on the subject for up to 1 hour of lens wear per visit (total of 2 fitting visits).
16095872|NCT02193503|Other|Treatment|Treatment is the implantation of loaded capsules + injection of irradiated autologous tumor cells
16095873|NCT02193490|Drug|DNase|DNase 0.1% eye drops four times a day for 8 weeks
16095874|NCT02193490|Drug|Vehicle|Drug vehicle eye drops four times a day for 8 weeks
16095875|NCT02193477|Device|TEAS|Electric stimulation was given through electrode attached to specific acupoints for 30mins before general anesthesia induction,1th day and 2nd day after surgery.
16095876|NCT02193477|Device|Sham TEAS|Electric stimulation was given through electrode attached to non-acupoints for 30mins before general anesthesia induction,1th day and 2nd day after surgery.
16095877|NCT02193451|Procedure|Urodynamics|Diagnostic test for urinary storage and voiding function
16095878|NCT02193451|Procedure|Usual care|
16095879|NCT02193438|Other|Spices intake|Each subject had to ingest a single dose of each of the spices and placebo. Recording of outcomes was realized throughout the 90 minutes following ingestion.
16095880|NCT02193438|Other|Placebo|Tomato juice intake
16095883|NCT02193412|Procedure|noxious stimulus|standardized noxious stimulus with tetanic stimulation
16095884|NCT02193412|Procedure|change in operating table slope: head-down tilt position|-30°
16095885|NCT02193412|Procedure|change in operating table slope: head-up tilt position|+30°
16095932|NCT02193087|Drug|TDV IDT Lyophilized|TDV Lyophilized Formulation for subcutaneous injection
16095933|NCT02193087|Drug|Placebo|TDV liquid formulation placebo-matching solution for subcutaneous injection
16095886|NCT02193399|Other|Physiotherapy in patients with stem cell transplantation|"The exercises are repeated in both upper limbs and both lower limbs. All exercises are performed with specific respiratory exercises simultaneously the movement that takes place each year form.
~The exercises are carried out by the physiotherapist applying in a passive way (ascending or descending) progressive strength and degree of difficulty and variables depending on the clinical condition of the patient."
16095887|NCT02193386|Other|No intervention, no follow-up, only registration|Usual Care
16095888|NCT02193386|Other|Intervention period|Predefined intervention program
16095889|NCT02193373|Other|Osteopathic Manual Medicine|Osteopathic Manual Medicine
16095890|NCT02193373|Other|Sham|Osteopathic Manual Medicine
16095891|NCT02193360|Drug|FFP104|Cohorts receiving multiple weekly or biweekly i.v. doses of FFP104. FFP104 dose levels: 1.0, 2.5 and 5.0 mg/kg. Subjects will be treated for 12 weeks and then followed for safety and efficacy assessments for an additional 12 weeks.
16095892|NCT02193347|Biological|PEPIDH1M vaccine|PEPIDH1M vaccine is made up of 500 µg of 25 amino acid peptide administered with 150 µg of GM-CSF mixed 1:1 with Montanide ISA 51 administered intradermally. The peptide vaccine is administered in the groin area approximately 10 cm below the inguinal ligament.
16095893|NCT02193347|Biological|Tetanus-Diphtheria Toxoid (Td)|After consent has been signed, all subjects will undergo standard of care vaccination with 0.5 mL of Td (tetanus and diphtheria toxoids adsorbed) intramuscularly (I.M.) into the deltoid muscle to ensure adequate immunity to the tetanus antigen. Within 48 hours of leukapheresis, subjects will receive a vaccine site pre-conditioning as a single dose of Td toxoid (1 flocculation unit, Lf, in a total volume of 0.4 mLs saline) administered intradermally to the right side of the groin one day prior to receiving the first PEPIDH1M vaccine.
16095894|NCT02193347|Drug|Temozolomide|Subjects are treated with temozolomide (TMZ) at a targeted dose of 50-100mg/m2/d for 21 days every 28 days for up to 12 cycles. Subjects that have transitioned to a higher grade brain tumor at time of surgery will receive TMZ and radiation therapy per standard of care before starting TMZ cycles.
16095895|NCT02193334|Drug|KP-100IT|
16095896|NCT02193334|Drug|Placebo|
16095897|NCT02193321|Biological|Amniotic Membrane Patch|
16095898|NCT02193308|Drug|Telmisartan/Amlodipine FDC|
16095899|NCT02193308|Drug|Telmisartan|
16095900|NCT02193308|Drug|Amlodipine|
16095901|NCT02193295|Drug|ACC Inhibitor|"Dietary consultations and caloric restriction to reduce liver and intra myocellular fat content and improve tissue specific insulin sensitivity.
~ACC Inhibition"
16095902|NCT02193282|Other|Clinical Observation|Undergo observation
16095903|NCT02193282|Drug|Erlotinib Hydrochloride|Given PO
16095904|NCT02193282|Other|Laboratory Biomarker Analysis|Correlative studies
16095905|NCT02193282|Other|Placebo Administration|Given PO
16095906|NCT02193269|Drug|Sugar pill|you will receive 0.0 mg as a single daily dose for 4 days
16095907|NCT02193269|Drug|Minocycline|you will receive 200 mg as a single daily dose for 4 days
16095908|NCT02193256|Drug|Varenicline|Titrated over 1 week to a maximum dose of 2mg/day
16095909|NCT02193256|Drug|Prazosin|Titrated over 3 weeks to a maximum dose of 8mg/day
16095910|NCT02193256|Drug|Placebo|
16095911|NCT02193217|Drug|MT-1303-Low|
16095912|NCT02193217|Drug|MT-1303-High|
16095913|NCT02193217|Drug|Fingolimod|
16095914|NCT02193217|Drug|Placebo|
16095915|NCT02193204|Behavioral|Personal Stress Imagery|"The stress imagery script will be based on participants' description of a recent personal event experienced as most stressful, and determined as such by rating it above 8 on a 10-point stress scale. These may include breakup with a significant other or job-related stress. A 5-minute 'script' of each scenario will be written using Scene Construction Questionnaires where physiological, bodily sensations regarding the event will be obtained. Scripts will then be recorded onto audiotape for guided imagery in the laboratory sessions."
16095916|NCT02193204|Behavioral|Neutral Imagery|The neutral script will be developed from a personal non-alcohol-related relaxing situation. A 5-minute 'script' of each scenario will be written using Scene Construction Questionnaires where physiological, bodily sensations regarding the event will be obtained. Scripts will then be recorded onto audiotape for guided imagery in the laboratory sessions.
16095917|NCT02193191|Drug|Plerixafor|
16095918|NCT02193178|Device|comfilcon A Toric|Contact lenses
16095919|NCT02193165|Drug|triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash|Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.
16095920|NCT02193165|Drug|stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash|Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.
16095921|NCT02193165|Drug|fluoride toothpaste + fluoride Mouthwash|Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.
16095922|NCT02193152|Drug|Pazopanib|
16095923|NCT02193139|Drug|WL8713, 6 mg|
16095924|NCT02193139|Drug|WL8713, 12 mg|
16095925|NCT02193139|Drug|WL8713, 18 mg|
16095926|NCT02193139|Drug|WL8713, 24 mg|
16095927|NCT02193139|Drug|Placebo|
16095928|NCT02193126|Other|Trauma Affect Regulation: Guide for Education and Therapy (TARGET)|The intervention is called the Trauma Affect Regulation: Guide for Education and Therapy (TARGET). TARGET is a manualized, psycho-educational intervention delivered in 10 - 12 sessions. TARGET is designed to address complex trauma and difficulties with emotional regulation and relational engagement that occur across a wide range of trauma-related difficulties, including trauma-related and behavioral symptoms. The full TARGET model consists of learning 7 essential core skills. These skills are called the FREEDOM steps: Focus, Recognize triggers, Emotion self-check, Evaluate thoughts, Define goals, Options, and Make a contribution.
16095929|NCT02193113|Drug|KVD001 Injection|A novel plasma kallikrein inhibitor
16095930|NCT02193087|Drug|TDV Liquid Formulation 1|TDV Liquid Formulation 1 for subcutaneous injection
16095934|NCT02193074|Drug|nusinersen|Administered by intrathecal (IT) injection as specified in the treatment arm.
16095935|NCT02193074|Procedure|Sham procedure|Small needle prick on the lower back at the location where the IT injection is normally made
16095936|NCT02193061|Biological|Rotarix|
16095937|NCT02193061|Biological|RotaTeq|
16095939|NCT02193035|Other|Microparticle levels|Microparticle levels will be evaluated with flow cytometry and nanoparticle tracking analysis
16095940|NCT02193022|Drug|Miltefosine|
16095941|NCT02193009|Behavioral|SipSmarter|6-month behavioral trial
16095942|NCT02193009|Behavioral|MoveMore|6 month behavioral trial
16095943|NCT02192996|Dietary Supplement|Probiotic|blood and fecal samples were collected from five VLBW preterms which were supplemented with a probiotic mixture of Bifidobacterium breve / Lactobacillus salivarius isolated from human milk
16095944|NCT02192970|Drug|Bevacizumab|
16095945|NCT02192957|Device|Lifepak 20E Defibrillator, Licence No: 61944|"Intervention will be carried out using Health Canada approved devices for electrical cardioversion, following the steps pre-specified in the Ottawa AF Protocol.
~Ottawa AF Cardioversion"
16095946|NCT02192944|Drug|Chloroquine|Chloroquine base 600 mg single dose. To monitor ECG 12 lead at 0 (pre-dose), 1, 2, 4, 8, 12 and 24 hours after dosing.
16095947|NCT02192944|Drug|Dihydroartemisinin-piperaquine|Dihydroartemisinin-piperaquine 120/960 mg single dose To monitor ECG 12 lead at: 0 (pre-dose), 1, 2, 4, 8, 12 and 24 hours after dosing.
16095948|NCT02192931|Drug|Creatine monohydrate|
16095949|NCT02192918|Behavioral|Airbrush|The American Academy of Dermatology Sun Smart pamphlet will be given at the baseline session. It has brief tips for reducing skin cancer risk, but does not mention sunless tanning or relaxation activities. Participants in the airbrush condition will receive 4 airbrush tan sessions, once every two weeks, over the course of 2 months.
16095950|NCT02192918|Behavioral|Airbrush Plus|The American Academy of Dermatology Sun Smart pamphlet will be given at the baseline session. It has brief tips for reducing skin cancer risk, but does not mention sunless tanning or relaxation activities. Participants will complete 4 airbrush tan sessions, once every two weeks, over the course of 2 months. Additionally, they may choose 8 sessions, 1 per week, of the following activities at no cost: massage, pedicure, yoga class, or dance class.
16095951|NCT02192918|Behavioral|Delayed Airbrush|The American Academy of Dermatology Sun Smart pamphlet will be given at the baseline session. It has brief tips for reducing skin cancer risk, but does not mention sunless tanning or relaxation activities. Participants will receive access to one of each of the following after the 6-month assessment at no cost: airbrush tan, massage, pedicure, yoga class, and dance class
16095952|NCT02192905|Behavioral|Diabetes Prevention Program Lifestyle Intervention|
16095953|NCT02192892|Dietary Supplement|CSB drum dried + α-amylase|CSB drum dried + α-amylase: Porridge from drum dried Corn Soy Blend with α-amylase
16095954|NCT02192892|Dietary Supplement|CSB + α-amylase|CSB + α-amylase: porridge from Corn Soy Blend with α-amylase
16095955|NCT02192892|Dietary Supplement|RSB + α-amylase|RSB + α-amylase: Porridge from Rice Soy Blend with α-amylase
16095956|NCT02192892|Dietary Supplement|WSB + α-amylase|WSB + α-amylase: Porridge from Wheat Soy Blend with α-amylase
16095957|NCT02192892|Dietary Supplement|CSB PLUS drum dried + α-amylase|CSB PLUS drum dried + α-amylase: Porridge from drum dried Corn Soy Blend PLUS with α-amylase
16095958|NCT02192892|Dietary Supplement|CSB PLUS + α-amylase|CSB PLUS + α-amylase: Porridge from Corn Soy Blend PLUS with α-amylase
16095959|NCT02192892|Dietary Supplement|RSB PLUS + α-amylase|RSB PLUS + α-amylase: Porridge from Rice Soy Blend PLUS with α-amylase
16095960|NCT02192892|Dietary Supplement|WSB PLUS + α-amylase|WSB PLUS + α-amylase: Porridge from Wheat Soy Blend PLUS with α-amylase
16095961|NCT02192892|Dietary Supplement|Commercial porridge flour|Porridge from commercial porridge flour
16095962|NCT02192892|Dietary Supplement|Commercial porridge bar|Porridge from commercial porridge bar
16095963|NCT02192892|Dietary Supplement|Commercial MSB + α-amylase|Commercial MSB + α-amylase: Commercial porridge from Mais Soy Blend with α-amylase
16095964|NCT02192879|Device|thoracic epidural|Thoracic Epidural catheters will be placed between T8-12 interspaces preoperatively. Epidural hydromorphone (200-600mcg) will be given preoperatively. TEA will be dosed intraoperatively with a continuous infusion of 0.25% bupivacaine at 3-6ml per hour. At the end of surgery, infusion will be changed to 0.125% bupivacaine + 10mcg/ml hydromorphone at 4-6ml/hour. In PACU, a PCEA button will given to the patient for bolus dosing of 1-2ml and a lockout of 30 minutes. Changes to the epidural infusion solution, rate, and PCEA bolus dosing will be made clinically as required by the Acute Pain Service (APS).
16095965|NCT02192879|Device|continuous paravertebral catheter|Bilateral PVB catheters will be placed between the T8-12 interspaces preoperatively. 10ml of 0.5% ropivacaine will be injected into the paravertebral space, then catheter placed. The same procedure will be used for the placement of the PVB catheter on the opposite side. The catheter may be bolused with 5ml 0.5% ropivacaine hourly intraoperatively if needed. In PACU, PVB catheters will be infused continuously with 0.2% ropivacaine at 8-12ml/hr. Subjects will also be given a hydromorphone PCA button to deliver additional IV opioid medication to the patient as needed.
16095966|NCT02192879|Drug|Patient-Controlled Analgesia|Intravenous hydromorphone PCA will be initiated postoperatively with dosing prescriptions made by the primary surgical team.
16095967|NCT02192853|Drug|sitagliptin|"In randomized order:
~Day 1: tablet of 25 mg of sitagliptin + i.v. GLP-1 infusion Day 2: tablet of 100 mg of sitagliptin + i.v. GLP-1 infusion Day 3: tablet of 200 mg of sitagliptin + i.v. GLP-1 infusion"
16095968|NCT02192853|Drug|Placebo|Day 4: placebo tablet
16095969|NCT02192840|Procedure|Coronary angioplasty with stent implantation|Coronary angioplasty in bifurcation lesion with drug-eluting stent implantation: BiOSS or regular DES (rDES)
16095970|NCT02192827|Drug|Dexamethasone Sodium Phosphate Injection|
16095971|NCT02192814|Drug|Lacosamide (200 mg/20 mL)|"Active Substance: Lacosamide
~Pharmaceutical form: Solution for intravenous (iv) infusion
~Concentration: adapted on concentration of oral dose in EP0009
~Route of Administration: Drip infusion"
16095972|NCT02192788|Radiation|Stereotactic Body Radiation Therapy for Oligometastases|
16095973|NCT02192775|Drug|MV-NIS|one dose in conjunction with a 4 day course intravenously
16095974|NCT02192762|Behavioral|Withdrawal regulation training|Withdrawal coping skills
16095975|NCT02192762|Behavioral|Relaxation training|Relaxation skills instruction
16095976|NCT02192749|Biological|Umbilical cord mesenchymal stem cells|
16095977|NCT02192736|Biological|Trophic factors from umbilical cord mesenchymal stem cells|
16095978|NCT02192723|Drug|Typical antipsychotic|Haloperidol (6~20mg/day) and perphenazine (16~64mg/day), twice per day, 8 weeks
16095979|NCT02192723|Drug|Risperidone|2~6mg/day, twice per day, 8 weeks
16095980|NCT02192723|Drug|Olanzapine|Olanzapine, 400~750mg/day, twice per day, 8 weeks
16095981|NCT02192723|Drug|Quetiapine|Quetiapine, 400～750mg/day, twice per day, 8 weeks
16095982|NCT02192723|Device|Aripiprazole|Aripiprazole, 10～30mg/day, twice per day, 8 weeks
16095983|NCT02192723|Drug|Ziprasidone|Ziprasidone 80~160mg/day, twice per day, 8 weeks
16095984|NCT02192710|Procedure|electronic tab|classic use of an electronic tab with age specific games
16095985|NCT02192710|Drug|Midazolam oral intake|
16095986|NCT02192697|Drug|ASP8273|Oral administration
16095987|NCT02192684|Drug|Pioglitazone|45 mg daily Insulin sensitizing
16095988|NCT02192684|Drug|placebo|Compare with pioglitazone
16095989|NCT02192671|Procedure|Hepatic Resection|Indications for HR are the presence of appropriate residual liver volume determined by volumetric computed tomography.
16095990|NCT02192671|Procedure|Radiofrequency Ablation|
16095991|NCT02192645|Drug|Sanfujiu|
16095992|NCT02192645|Drug|Placebo|The placebo ointment is composed of flour, buckwheat flour, food colorants and water, resulting in an ointment similar in appearance to the Sanfujiu ointment.
16095993|NCT02192632|Drug|Epiduo once daily with detailed instruction for how to apply it|
16095994|NCT02192632|Drug|Epiduo- once daily, simple instruction for application|
16095995|NCT02192632|Drug|BPO once daily|
16095996|NCT02192619|Other|observational|
16095997|NCT02192606|Device|Storz 3D Laparoscopy System|The Storz 3D Laparoscopy System is a new device that allows for laparoscopic surgeons to utilize 3D imaging during surgery with a fraction of the cost of the da Vinci Surgical System, a three-dimensional visual system.
16095998|NCT02192606|Device|2D Laparoscopy|The standard 2D Laparoscopy System to be used at time of the total laparoscopic hysterectomy.
16095999|NCT02192593|Behavioral|Computer CBT|
16096000|NCT02192580|Drug|Omega-3|Children less than 18 kg:26 mg/kg EPA and 11 mg/kg DHA Children 18-24 kg:504 mg EPA and 216 mg DHA Children 25-32 kg:672 mg EPA and 288 mg DHA Children 33-41 kg:840 mg EPA and 360 mg DHA Children 5-15 years:1000 mg EPA and 878 mg DHA omega-3 in divided 3 times/day in addition to standard regimens
16096001|NCT02192567|Drug|DS-5573a|"Step 1 of this study will use a starting intravenous (IV) dose of 0.1 mg/kg. Eight dose levels are planned, level 1: 0.1 mg/kg, level 1.5: 0.1 mg/kg, 0.3 mg/kg, level 2: 0.3 mg/kg, level 3: 1 mg/kg, level 4: 3 mg/kg, level 5: 10 mg/kg, level 6: 20 mg/kg, level 7: 30 mg/kg.
~Step 2: 30 subjects will use the dose determined in Step 1."
16096002|NCT02192541|Drug|Ziv-Aflibercept|Ziv-aflibercept is a soluble fusion protein with high binding affinity for vascular endothelial growth factor A (VEGF-A), vascular endothelial growth factor B (VEGF-B), and placenta growth factor (PIGF) and thus confers anti-angiogenic activity
16096003|NCT02192541|Drug|Ganetespib|Ganetespib is a non-geldamycin synthetic inhibitor of Hsp90 with activity against multiple cancer cell lines and tumor xenografts in preclinical models.
16096004|NCT02192515|Drug|APD356 10 mg|One tablet of APD356 10 mg will be orally administered in fasted state.
16096005|NCT02192515|Drug|APD356 XR-20 mg|One tablet of APD356 XR-20 mg will be orally administered in fasted state.
16096006|NCT02192515|Drug|APD356 10 mg matching Placebo|One tablet of APD356 10 mg matching placebo will be orally administered in fasted state.
16096007|NCT02192515|Drug|APD356 XR-20 mg matching Placebo|One tablet of APD356 XR matching placebo will be orally administered in fasted state.
16096008|NCT02192515|Drug|APD356 20 mg|Two tablets of APD356 10 mg will be orally administered in fasted state.
16096009|NCT02192515|Drug|APD356 20 mg matching Placebo|Two tablets of APD356 10 mg matching placebo will be orally administered in fasted state.
16096010|NCT02192515|Drug|APD356 XR-20 mg (orange tablet)|One tablet of APD356 XR-20 mg orange tablet will be orally administered in fasted state.
16096011|NCT02192515|Drug|APD356 XR-20mg (orange tablet, fed state)|One tablet of APD356 XR-20 mg orange tablet will be orally administered 30 minutes after the start of a meal.
16096012|NCT02192502|Drug|human albumin 5%|
16096013|NCT02192502|Drug|HES 130/0.4 (Voluven)|
16096014|NCT02192489|Drug|CC-220 0.3 mg Daily|
16096015|NCT02192489|Drug|CC-220 0.6mg Daily|
16096016|NCT02192489|Drug|Placebo|
16096017|NCT02192476|Other|conventional neuro rehabilitation programme|All the conventional group subjects were received standardized conventional neuro rehabilitation programme. The conventional neuro rehabilitation treatment includes, active, and passive range of motion exercise, bilateral activation of pectoralis major, activation of latissimus dorsa, activation of the retractors, weight bearing exercise of upper extremity, activation of supraspinatus, reaching activities, grasping, holding and release, and activity of daily living (ADL) activities. Every participant was received conventional neuro rehabilitation for 45 minutes and 5 days a week.
16096018|NCT02192476|Other|California tri-pull taping (CTPT)|"Two types of tape was used, a self-adhesive 1.5 cotton undercover tape and a 1 rigid strapping tape. Participants placed their affected arm on a supporting surface to better approximate the humeral head back into the glenoid fossa. The three pieces of rigid tape were applied to the patient's shoulder on top of the already applied self-adhesive cotton tape."
16096019|NCT02192463|Drug|NVP ER 300 mg (KCR 20%) Medium Release|
16096020|NCT02192463|Drug|NVP ER 300 mg (KCR 25%) Medium Release|
16096021|NCT02192463|Drug|NVP ER 300 mg (KCR 30%) Slow Release|
16096022|NCT02192463|Drug|NVP ER 400 mg (KCR 25%) Medium Release|
16096023|NCT02192463|Drug|NVP ER 300 mg (KCR 40%) Slow Release|
16096024|NCT02192463|Drug|NVP ER 300 mg (ECR 20%) Fast Release|
16096025|NCT02192463|Drug|NVP ER 400 mg (KCR 20%) Medium Release|
16096026|NCT02192463|Drug|NVP ER 400 mg (KCR 30%) Slow Release|
16096027|NCT02192463|Drug|NVP ER 400 mg (KCR 40%) Slow Release|
16096028|NCT02192463|Drug|NVP ER 400 mg (ECR 20%) Fast Release|
16096029|NCT02192463|Drug|Nevirapine immediate release (IR) 200 mg|
16096030|NCT02192450|Drug|Insulin aspart/glargine|
16096031|NCT02192450|Drug|Insulin aspart/degludec|
16096032|NCT02192437|Other|Sulfur amino acid restricted diet|Methionine restricted diet: 70% or 90% restriction Methionine and cysteine restricted diet: 50% or 65% restriction
16096033|NCT02192424|Drug|Metformin alone|
16096034|NCT02192424|Drug|Metformin + Intermittent Insulin Therapy|
16096035|NCT02192411|Drug|Lidocaine|1/4 dose lidocaine
16096036|NCT02192398|Drug|Guanfacine|"Subjects will be randomized into 1 of the following 3 treatment groups:
~guanfacine (2mg)
~guanfacine (1mg)
~placebo
~To compare pain threshold, pain tolerance, and wind up, as measured by QST, throughout 4 weeks of drug treatment (guanfacine or placebo)."
16096037|NCT02192398|Drug|Placebo|"Subjects will be randomized into 1 of the following 3 treatment groups:
~guanfacine (2mg)
~guanfacine (1mg)
~placebo To compare pain threshold, pain tolerance, and wind up, as measured by QST, throughout 4 weeks of drug treatment (guanfacine or placebo)."
16096038|NCT02192359|Biological|Carboxylesterase-expressing Allogeneic Neural Stem Cells|Given intracranially
16096039|NCT02192359|Drug|Irinotecan|Given IV
16096040|NCT02192359|Drug|Irinotecan Hydrochloride|Given IV
16096041|NCT02192359|Other|Laboratory Biomarker Analysis|Correlative studies
16096042|NCT02192359|Other|Pharmacological Study|Correlative studies
16096043|NCT02192346|Drug|2.4 mg/kg α-TEA|Patients receive oral α-TEA 2.4 mg/kg daily for the first 14 days of a 28 day cycle.
16096044|NCT02192346|Drug|4.8 mg/kg α-TEA|Patients will receive oral α-TEA 4.8 mg/kg daily for the first 14 days of a 28 day cycle.
16096045|NCT02192346|Drug|8.0 mg/kg α-TEA|Patients will receive oral α-TEA 8.0 mg/kg daily for the first 14 days of a 28 day cycle.
16096046|NCT02192346|Drug|9.6 mg/kg α-TEA|Patients will receive oral α-TEA 9.6 mg/kg daily for the first 14 days of a 28 day cycle.
16096047|NCT02192346|Drug|12 mg/kg α-TEA|Patients will receive oral α-TEA 12 mg/kg daily for the first 14 days of a 28 day cycle.
16096048|NCT02192346|Drug|16.8 mg/kg α-TEA|Patients will receive oral α-TEA 16.8 mg/kg daily for the first 14 days of a 28 day cycle.
16096049|NCT02192346|Drug|19.2 mg/kg α-TEA|Patients will receive oral α-TEA 19.2 mg/kg daily for the first 14 days of a 28 day cycle.
16096050|NCT02192346|Drug|22.3 mg/kg α-TEA|Patients will receive oral α-TEA 22.3 mg/kg daily for the first 14 days of a 28 day cycle.
16096051|NCT02192346|Drug|26.8 mg/kg α-TEA|Patients will receive oral α-TEA 26.8 mg/kg daily for the first 14 days of a 28 day cycle.
16096052|NCT02192333|Procedure|Management of Therapy Complications|Receive survivorship care
16096053|NCT02192333|Other|Quality-of-Life Assessment|Ancillary studies
16096054|NCT02192333|Other|Questionnaire Administration|Ancillary studies
16096055|NCT02192333|Behavioral|Telephone-Based Intervention|Receive phone-based booster intervention
16096056|NCT02192320|Drug|Atorvastatin|20 mg (every evening orally) for 5 weeks
16096057|NCT02192320|Drug|Atorvastatin and Dexamethasone|"Atorvastatin: 20 mg (every evening orally) for 5 weeks;
~Dexamethasone:0.75mg Tid (1st-2nd week), 0.75mg Bid (3th week), 0.75mg Qd (4th week), 0.375mg Qd (5th week)"
16096058|NCT02192307|Device|Potassium oxalate|
16096059|NCT02192294|Drug|Oral Bosutinib|a single dose of 500 mg oral bosutinib
16096060|NCT02192294|Drug|Intravenous infusion of bosutinib|a single dose of 120 mg of bosutinib intravenous infusion (1 hour)
16096061|NCT02192281|Other|Playworks|The Playworks program places full-time coaches in low-income schools to provide opportunities for organized play during recess and throughout the school day.
16096062|NCT02192268|Other|PEP|
16096063|NCT02192268|Other|HFOO|
16096064|NCT02192268|Other|Assisted Coughing|
16096065|NCT02192255|Behavioral|Intervention Phone Call|The intervention arm consisted of one protocol-structured telephone call from an interventionist who was a nurse health manager (1 site), diabetes educator or diabetes educator trainee (1 site), or pharmacist (2 sites). Interventionists followed the same structured telephone interview protocol to ascertain whether the subject had started taking the new prescription. Those taking the new medication as prescribed received positive reinforcement. Those who either had not filled the prescription or were not taking the medication as directed, were asked about reasons for nonadherence and assisted in identifying and resolving barriers. The median call lasted < than 5 minutes, and up to 3 call attempts were made. Most intervention calls occurred within 2 to 6 weeks after the prescription date.
16096066|NCT02192242|Other|acute ischemic pain|acute ischemic pain was induced by treadmill exercise
16096067|NCT02192229|Drug|50.000 IU vitamin D3 (Biodal 50,000 IU)|
16096068|NCT02192229|Drug|Placebo (to mimic Biodal 50,000 IU)|Placebo Tablet will be manufactured in a pharmaceutical factory to be identical to vitamin D3 Tablet in color, shape, size, and packaging
16096069|NCT02192216|Behavioral|Exercise|
16096070|NCT02192203|Drug|Diclofenac + Menthol Gel|1% diclofenac, 3% menthol
16096071|NCT02192203|Drug|Diclofenac Only Gel|1% diclofenac, 0.09% menthol
16096072|NCT02192203|Drug|Menthol Only Gel|3% menthol
16096073|NCT02192203|Drug|Placebo Only Gel|0.09% menthol
16096074|NCT02192190|Drug|LY2951742|Administered subcutaneously (SC)
16096075|NCT02192190|Other|Placebo- oral|Administered orally
16096076|NCT02192190|Other|Placebo - SC|Administered SC
16096077|NCT02192190|Drug|Celecoxib|Administered orally
16096078|NCT02192164|Behavioral|smoking questionnaire|patients fill in a smoking questionnaire about their smoking habits
16096079|NCT02192138|Procedure|Therapeutic thoracentesis|Therapeutic thoracentesis with pleural fluid withdrawal
16096080|NCT02192138|Device|Pleural catheter|
16096081|NCT02192138|Device|Pleural manometer|
16096082|NCT02192125|Device|REWIRE-System|"The REWIRE rehabilitation platform consists of three hierarchical components:
~patient station (PS), which is installed in the home environment of the patient:
~Includes:
~Laptop with software - Game Tymoplate® - balanceboard Kinect® - 3D tracking
~Hospital Station (HS), which allows an exchange of information with more patient station and is served by the therapists in the hospital;
~Includes:
~Laptop MySQL- database
~station networking (NS), which allows a combination of a several of HS. database"
16096083|NCT02192099|Drug|Rapastinel (225 mg/450 mg IV administration)|Investigators began treatment in RAP-MD-05 based on the dose level to which the patient was assigned during participation in GLYX13-C-202; patients originally assigned to rapastinel 5 mg/kg received rapastinel 225 mg, and patients originally assigned to rapastinel 10 mg/kg received rapastinel 450 mg. Investigators had the option to decrease the dose level from 450 to 225 mg if a patient experienced an adverse event(s) that the investigator believed may be associated with rapastinel
16096084|NCT02192086|Other|goal directed fluid therapy|"The treatment group will initially be given a 1L bolus after induction over 20 minutes (first liter may be Lactated Ringers solution or Plasmalyte, subsequent fluid will be Plasmalyte) followed by maintenance infusion at a rate of 5mL/kg/hr until the graft kidney is removed from ice. After removing the organ from ice, the kidney recipient will be administered supplemental crystalloid until PVI is 10 or lower. Plasmalyte will be warmed in accordance to the departmental hypothermia protocol. A PVI of 12 or lower will be maintained until emergence of anesthesia, at which time the PVI monitor will be removed and all patients will be managed by existing standards (pain control, fluid replacement, hemodynamic goals, etc).
~a.At the time the treatment group begins receiving goal directed fluid therapy the anesthesia team is to wean any vasopressors aggressively with the goal of terminating infusion as quickly as is safe."
16096085|NCT02192086|Other|Control Group|"Control patients will be given a constant infusion of crystalloid (first liter may be Lactated Ringers solution or Plasmalyte, subsequent fluid will be Plasmalyte) at a rate determined by the following: 70mL/kg for the duration of the surgery, 1L bolus after induction (over 20-30 minutes) followed by the remainder as a constant infusion determined by (70mL/kg * wt - 1000mL) / 160 minutes (using the local average of approximately 180 minutes of operative time).
~a.A Masimo PVI monitor will be placed on the patient on an extremity not affected by an AV fistula and recorded for evaluation, but no fluid administration decisions will be made based on it (providers will not have access to its values)."
16096086|NCT02192073|Procedure|Suprapectoral Biceps tenodesis|
16096087|NCT02192073|Procedure|Subpectoral biceps tenodesis|
16096088|NCT02192060|Other|Test - Using of a suspension containing Triclosan|The participants should have used only the suspension containing Triclosan during 5 days and have stopped with their biofilm control homemade procedures.
16096089|NCT02192060|Other|Control - Using of a suspension without Triclosan|The participants should have used only the Placebo suspension during 5 days and have stopped with their biofilm control homemade procedures.
16096090|NCT02192047|Other|Palm Olein|8 weeks
16096091|NCT02192047|Other|IE Palm olein|8 weeks
16096092|NCT02192047|Other|IE soybean oil-based|8 weeks
16096093|NCT02192034|Behavioral|Navigation|
16096094|NCT02192021|Drug|Micro needle array-Doxorubicin (MNA-D)|MNA-D patches will be applied to 3-4 CTCL skin patches or plaques at each weekly visit (4/cycle). The initial safety, dose-finding phase will include one cycle of applications and the second phase will include weekly applications (4/cycle) for up to 6-8 cycles.
16096095|NCT02192008|Biological|Salmonella Typhi|
16096096|NCT02192008|Biological|Salmonella Paratyphi|
16096097|NCT02191995|Behavioral|yoga|
16096098|NCT02191982|Behavioral|Walk With Ease|Walk With Ease is the Arthritis Foundation's evidence-based walking intervention to help with fatigue and pain. The intervention is a self-directed program that helps guide participants in a safe and comfortable paced walking program with an ultimate goal of walking for 30 minutes a day, five days a week.
16096099|NCT02191969|Behavioral|Walk With Ease|A self-directed walking intervention developed by the Arthritis Foundation. The intervention is a workbook that coaches participants through walking regularly at a safe, comfortable pace with the ultimate goal of walking at least 30 minutes a day five days a week.
16096100|NCT02191956|Behavioral|Behavioral Parent Training|Weekly clinic session, mid-week call, home practice
16096101|NCT02191943|Device|Duraphat|The subjects in the control group will be the subject of personalized oral hygiene instructions on the basis of obtained indices, and will also receive a professional prophylaxis. Following this, the surfaces of the teeth in the control group involved in the trial will be treated with a fluoride varnish (Duraphat®) that will be applied with a brush to all surfaces of the teeth, working the varnish approximally with the brush. This treatment will be repeated in the comparative group at each follow-up appointment.
16096102|NCT02191943|Device|Icon approximal caries infiltration kit|Carious lesions in the teeth in the test group shall be treated with the infiltrant ICON® according to the manufacturer's instructions. Step by step instructions for application are as follows:
16096103|NCT02191930|Drug|B-CAP|
16096104|NCT02191930|Drug|Brentuximab Vedotin|
16096105|NCT02191917|Procedure|Respiratory muscle strength measurements by different techniques.|
16096106|NCT02191904|Other|Macintosh type, Truview EVO2® type and Airtraq® type laryngoscopes|
16096107|NCT02191891|Drug|BI 836845|Human monoclonal antibody. Two dose levels (high or low) depending on the dose cohort explored
16096108|NCT02191891|Drug|afatinib|Irreversible EGFR tyrosine kinase inhibitor. Two dose levels (30 mg, 40 mg) depending on the dose cohort explored or determined dose at part A
16096109|NCT02191878|Drug|TKM-080301|TKM-080301 intravenous infusion
16096110|NCT02191865|Drug|Nintedanib|Soft gelatine capsule
16096111|NCT02191865|Drug|Nintedanib|Soft gelatine capsule
16096112|NCT02191865|Drug|Nintedanib|Soft gelatine capsule
16096113|NCT02191852|Drug|Seresis®|
16096114|NCT02191839|Drug|Alpha 1-Antitrypsin|
16096115|NCT02191826|Drug|SOM0226|Oral
16096116|NCT02191813|Drug|Seresis®|
16096117|NCT02191813|Drug|Placebo|
16096118|NCT02191787|Drug|Seresis®|
16096119|NCT02191787|Drug|Placebo|
16096120|NCT02191774|Procedure|Medical abortion at home|Medical abortion using Mifepristone at the clinic followed by Cytotec at home
16096121|NCT02191761|Drug|SM04755|Escalating Doses
16096122|NCT02191748|Procedure|Needling|Needling is a procedure in which a needle is inserted into normally pigmented skin on the rim of a vitiligo patch and then is pushed into the center of the patch, theoretically moving healthy, pigmented skin cells into the vitiligo patch.
16096123|NCT02191748|Drug|Triamcinolone|During the process of needling, the needle will be attached to a syringe filled with a steroid, which is then injected into the patch, enabling delivery of the steroid directly to the affected area
16096255|NCT02190591|Device|Peanut Labor Ball|Peanut Labor Ball
16096124|NCT02191735|Device|RAMP 200|The RAMP® Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm. The RAMP® 200 is Response Biomedical's second generation reader. The RAMP® 200 is designed to process more tests with a smaller footprint.
16096125|NCT02191735|Device|RAMP Reader|The RAMP® Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm. The RAMP® Reader is Response Biomedical's first generation reader instrument. Designed for use at near-patient/bedside or locations such as: laboratories, hospitals, on-site Emergency Response and Emergency Rooms.
16096126|NCT02191722|Behavioral|reading comics booklet|
16096127|NCT02191709|Drug|Dextromethorphan syrup|
16096128|NCT02191709|Drug|Dextromethorphan soft pastilles|
16096129|NCT02191696|Device|IMED-4 recording|
16096130|NCT02191670|Drug|METALYSE®|weight-adjusted dosage as single bolus over 5 to 10 seconds
16096131|NCT02191657|Drug|Deferiprone|Oral iron chelator
16096132|NCT02191644|Dietary Supplement|Dietary intervention-refined rice|Subjects in the control group maintained the usual refined-rice diet.
16096133|NCT02191644|Dietary Supplement|Dietary intervention-whole grains and legumes|Subjects in the whole-grain group replaced refined rice with a mix of 1/3 legumes, 1/3 barley, and 1/3 wild rice three times per day, and increased vegetable intake to at least 6 units (30-70 g/unit) per day for sufficient dietary fiber intake.
16096134|NCT02191631|Behavioral|Internet-delivered Cognitive Behavior Therapy|The treatment consists of standard cognitive behavior therapy for obsessive-compulsive disorder and is delivered via an internet plattform and regular therapist contact several times per week via email and telephone. The treatment is 12 weeks.
16096135|NCT02191618|Device|WEB|The WEB is an intra-aneurysmal device intended for use in endovascular embolization of intracranial aneurysms.
16096136|NCT02191605|Behavioral|eSBIRT|A single 20 minute interactive computer-delivered intervention designed to promote motivation to change prenatal marijuana use, without presuming the participant to be currently using marijuana while pregnant.
16096137|NCT02191605|Behavioral|Tailored texting|Group text messaging software from Trumpia, Inc. will be used to create the tailored text messages that will be sent to participants assigned to this intervention. Text messages will sent after the initial study participation visit until childbirth or participant opts out of receiving them.
16096138|NCT02191579|Biological|onabotulinumtoxinA|155U onabotulinumtoxinA (BOTOX®) total dose per treatment by intramuscular injection every 12 weeks.
16096139|NCT02191579|Drug|Topiramate|Topiramate up to a maximum oral dose of 100 mg/day.
16096140|NCT02191566|Drug|S-1 (452500ACH)|S-1 80 mg/m²/day from day 1 to day 14, every 21 days, for 12 months
16096141|NCT02191566|Drug|OXALIPLATIN (205803BIJ)|Oxaliplatin 130 mg/m² for day 1, every 21 days, for 6 months
16096142|NCT02191553|Behavioral|Control group relaxation techniques|Jacobson's progressive muscular relaxation, emotional imagining and Schultz's autogenic training.
16096143|NCT02191553|Behavioral|Loving-kindness meditation|Following Kristin Neff protocol
16096144|NCT02191553|Behavioral|Body scan|Body scan: Attention being directed with detailed awareness to every part of the body for a sustained period of time.
16096145|NCT02191553|Behavioral|Sitting practice|In the sitting exercise, participants are guided to pay attention to a certain range of still points, starting with attention to breathing. In this exercise attention is fully concentrated on a single object: the sensation attached to breathing. If the mind wanders or is distracted by an external stimulus, attention is gently returned to sensations derived from breathing.
16096146|NCT02191540|Drug|Abnoba Viscum F 20mg|intravesical instillation of five amples of AbnobaViscum® F20mg and 0.9% normal saline into the pleural space
16096147|NCT02191527|Device|PIMA® for quantitative analysis of CD4-count|
16096148|NCT02191527|Device|Hemocue® (HemoCue AB, Angelhom, Sweden) for quantitative analysis of hemoglobin|
16096149|NCT02191527|Device|SD Bioline® (Standard Diagnostics Inc., South-Korea) for qualitative analysis of syphilis|
16096150|NCT02191501|Procedure|Pyloric restriction|"The Apollo Overstitch Suturing Device is FDA approved for suturing in the gastrointestinal tract.
~However, the suturing device has never been used for suturing the pylorus in humans before. This procedure is not standard medical care. The safety and effectiveness of this procedure are being tested."
16096151|NCT02191488|Drug|5-aminolevulinic acid|
16096152|NCT02191475|Drug|glycopeptide plus carbapenem|The control group antibiotic selection according to the classical scheme use of glycopeptide plus carbapenem antibiotic (or oxazolidinone antibiotics), with or without antifungal therapy
16096153|NCT02191475|Drug|Haizheng Li Xing ® plus tazocin ®|Tigecycline (Haizheng Li Xing ®) combined with piperacillin/tazobactam (tazocin ®), with or without antifungal therapy
16096154|NCT02191462|Dietary Supplement|Niagen 100mg|
16096155|NCT02191462|Dietary Supplement|Niagen 300mg|
16096156|NCT02191462|Dietary Supplement|Niagen 1000mg|
16096157|NCT02191423|Drug|Oxytocin|administered pre-fMRI assessment
16096158|NCT02191423|Drug|placebo|administered pre-fMRI assessment
16096159|NCT02191423|Behavioral|Dyadic psychotherapy|
16096160|NCT02191410|Procedure|High Frequency Positive Pressure Ventilation|TV 2 mL kg-1 PBW, I:E ratio > 0.3, RR 60 breaths min-1 and a FGF of < 2 L min-1, using a second identical ventilator with low compliant internal circuit
16096161|NCT02191410|Procedure|Continuous Positive Airway Pressure|CPAP of 2 cm H2O
16096162|NCT02191397|Drug|Bupropion|Bupropion is an extended-release plain creamy white colored tablet which contains bupropion hydrochloride equivalent to 150 mg of bupropion.
16096163|NCT02191397|Drug|Bupropion Matching Placebo|Bupropion hydrochloride matching placebo tablets will be supplied to maintain blinding
16096164|NCT02191397|Drug|Escitalopram|Escitalopram is available as a Swedish orange capsule containing escitalopram oxalate equivalent to 10 mg of escitalopram.
16096165|NCT02191397|Drug|Escitalopram Matching Placebo|Escitalopram oxalate matching placebo tablets will be supplied to maintain blinding
16096166|NCT02191384|Drug|Orcinoside|oral, twice per day
16096167|NCT02191371|Drug|propofol|Patients are randomized to receive intravenous anesthetic (propofol) or inhalational anesthetic (desflurane) as a maintenance anesthetic.
16096887|NCT02185729|Drug|ClinOleic|Infusion of ClinOleic (olive oil-based)
16096168|NCT02191371|Drug|desflurane|Patients are randomized to receive intravenous anesthetic (propofol) or inhalational anesthetic (desflurane) as a maintenance anesthetic.
16096169|NCT02191345|Behavioral|Guided Imagery|Guided imagery is a stress management technique that uses verbal suggestion and descriptive language to guide the listener into imagining sensations and visualizing images in the mind in order to bring about a desired physical response, such as reduction in anxiety, stress, or pain. The guided imagery tracks chosen for the study were chosen because their goal is relaxation and stress relief, and their length is under 15 minutes.
16096170|NCT02191332|Drug|Viramune|
16096171|NCT02191319|Drug|Viramune®|
16096172|NCT02191293|Drug|Viramune® tablets|
16096173|NCT02191280|Drug|Antistax®, low dose|
16096174|NCT02191280|Drug|Antistax®, high dose|
16096175|NCT02191280|Drug|Placebo|
16096176|NCT02191267|Radiation|[F18]-T807|[F18]-T807 PET Scan to measure tau deposition in the brain.
16096177|NCT02191267|Radiation|[F18]-Florbetapir|[F18]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain.
16096178|NCT02191267|Device|MRI/MRS|Two scans (structural, diffusion tensor imaging, and susceptibility weighted imaging scanned as part of one MR protocol, and a one-dimensional and two-dimensional spectroscopy examination as part of the other MR protocol.
16096179|NCT02191267|Genetic|Genetic Analysis for Genetic Risk Score for Tau.|DNA will be extracted from previously acquired and de-identified frozen blood specimens using a standard protocol (Gentra Puregene Kit, Qiagen 158422). Genotyping will be performed using the iPLEX Sequenom MassARRAY platform and samples will be genotyped for single nucleotide polymorphisms (SNPs) associated with the deposition of neurofibrillary tangles.
16096180|NCT02191254|Drug|Antistax®|
16096181|NCT02191254|Drug|Placebo|
16096182|NCT02191241|Drug|Red Vine Leaf Extract|
16096183|NCT02191228|Drug|Linagliptin - single dose|
16096184|NCT02191228|Drug|Linagliptin - Multiple dose|
16096185|NCT02191215|Drug|Nevirapine (Viramune®)|
16096186|NCT02191202|Drug|Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)|
16096187|NCT02191189|Drug|Nevirapine suspension, into Enterion™ capsule|
16096188|NCT02191189|Drug|Nevirapine suspension|
16096189|NCT02191176|Drug|Dextromethorphan syrup - low dose|
16096190|NCT02191176|Drug|Dextromethorphan syrup - high dose|
16096191|NCT02191176|Drug|Placebo|
16096192|NCT02191163|Drug|Antistax®|
16096193|NCT02191163|Drug|Placebo|
16096194|NCT02191137|Drug|Riociguat (Adempas, BAY63-2521)|Participants received therapy with riociguat during a 10-week titration phase. The starting dose for riociguat for all patients was 0.5 milligram (mg) three times a day (TID). The dose of riociguat was increased every 2 weeks in 0.5 mg increments to 1.0, 1.5, 2.0, and 2.5 mg until patients reached their individual optimal dose based on their systolic blood pressure and well-being. After reaching their optimal dose, patients then entered a maintenance phase and remained on this dose for an additional 14 weeks. End of treatment was reached at Visit 10 after 24 weeks of treatment with riociguat.
16096195|NCT02191124|Drug|Paroxetine|Patients in both groups (MBC or ST) receive open-label paroxetine (20-60mg/day) within the therapeutic dose range recommended by the Guidelines for the Prevention and Treatment of Major Depression in China.
16096196|NCT02191124|Drug|Mirtazapine|Patients in both groups (MBC or ST) receive open-label mirtazapine (15-45mg/day) within the therapeutic dose range recommended by the Guidelines for the Prevention and Treatment of Major Depression in China
16096197|NCT02191111|Behavioral|Task-focused facilitation|An external, task-focused facilitation, informed by an evaluation of contextual factors using the Alberta Context Tool (ACT), will be applied to train community pharmacies to develop alternative team processes that enable a greater number of medication management services to be provided to patients with diabetes, hypertension, and/or dyslipidemia.
16096198|NCT02191098|Drug|ALT-803|Interleukin 15 (IL-15) is a common γ-chain cytokine that is related to interleukin-2 (IL-2) and is a critical factor for the development, proliferation, and activation of effector natural killer (NK) and CD8+ memory T cells
16096199|NCT02191085|Procedure|Fast Track|"In the Fast Track arm, an ACP will perform the initial assessment and will determine the management plan with the patient. To ensure patient safety, the management plan will be discussed with a sleep respirologist, who will be designated as the patient's primary sleep physician. This sleep physician will be available at the FMC Sleep Centre during the Fast Track clinic to assist with the assessment of patients who appear unwell. As in the Standard Management arm, follow-up visits to review test results, discuss and initiate treatment, or to assess treatment response may occur with the ACP who performed the initial assessment or may be delegated to any other ACP."
16096200|NCT02191072|Drug|omalizumab|a recombinant DNA-derived humanized IgG1k monoclonal antibody that specifically binds to free human immunoglobulin E (IgE)
16096201|NCT02191059|Drug|Icotinib|
16096202|NCT02191059|Drug|Docetaxel|
16096203|NCT02191046|Device|squeezable bottle|nasal irrigation twice daily for 2 weeks period
16096204|NCT02191046|Device|syringe 20 ml|nasal irrigation twice daily for 2 weeks
16096205|NCT02191033|Behavioral|Smoking counseling|
16096206|NCT02191033|Behavioral|Text messaging|
16096207|NCT02191033|Drug|Nicotine patch|
16096208|NCT02191020|Drug|Total glucosides of paeony & Acitretin Capsules|
16096209|NCT02191020|Drug|Acitretin Capsules|
16096210|NCT02191007|Drug|Calcipotriol Betamethasone ointment and Calcipotriol ointment|
16096211|NCT02191007|Drug|Calcipotriol Betamethasone ointment|
16096212|NCT02191007|Drug|Calcipotriol Betamethasone ointment and Urea Cream|
16096213|NCT02190994|Drug|Hydrocortisone|used intravenously
16096214|NCT02190994|Drug|Prednisone|used as tablet form
16096215|NCT02190981|Device|Ultrasound for Small Bowel Obstruction|Point-of-care ultrasound to evaluate emergency department patients for suspected small bowel obstruction
16096216|NCT02190968|Behavioral|Usual Depression Care|Usual Depression Care will be based on the Kaiser Permanente Adult Depression National Guidelines - an adaptation of STAR*D (Rush et al., 2006) for antidepressant management and the IMPACT (Unitzer et al., 2002; 2008) model for therapy.
16096256|NCT02190578|Device|Reveal G4|All subjects tested with the investigational device, Reveal G4, plus with an algorithm of approved assays for HIV.
16096888|NCT02185729|Drug|Dextrose|Infusion of dextrose (sugar) without fat
16096217|NCT02190968|Behavioral|Mindful Mood Balance|Mindful Mood Balance is an individually tailored, web-based version of Mindfulness-Based Cognitive Therapy, a manualized, group skills training program (Segal et al., 2002) that is based on an integration of aspects of cognitive therapy for depression (Beck, 1979) with components of the mindfulness-based stress reduction program (Kabat-Zinn, 1990). Patients participated in 8 internet sessions, each of which incorporates didactic and experiential learning, along with home practice of skills taught in the program.
16096218|NCT02190903|Other|General endotracheal anesthesia|"General Anesthesia
~Patients randomized to receive general anesthesia induction of anesthesia with intravenous lidocaine, propofol, fentanyl citrate and vecuronium or cisatracurium, following dosing guidelines defined by protocol. Following tracheal intubation, anesthesia will be maintained with sevoflurane in oxygen and air as defined by protocol. End-tidal gas monitoring (for carbon dioxide and sevoflurane) and maintenance, monitoring, and reversal of neuromuscular blockade will be as per HUP and PPMC routine. Immediate postoperative analgesia will be via IV dilaudid dosed intraoperatively as defined by protocol."
16096219|NCT02190903|Other|Regional (spinal) Anesthesia|Patients randomized to receive spinal anesthesia will undergo spinal blockade using standard techniques and medications dosed as per protocol, and will include hyperbaric bupivicaine or tetracaine, fentanyl citrate, and epinephrine; algorithms for management of spinal-related hypotension will be defined by protocol. Intraoperative sedation will be achieved via continuous intravenous propofol infusion; supplemental oxygen will be provided by nasal cannula or facemask as needed.
16096220|NCT02190890|Procedure|Dry needling|
16096221|NCT02190890|Procedure|Control|
16096222|NCT02190851|Device|TENS|"Two electrodes are attached around the internal malleolus and connected to the TENS unit.
~The sessions last 20 minutes daily (frequency 10Hz, duration 200µs), at maximum intensity of painless stimulation, every day at the same time, on the right side for 3 months."
16096223|NCT02190851|Device|Control|The device will have been previously set to deliver a stimulation below the effective threshold. In all cases, the device displays 20mA. Stimulation sessions are 20 minutes daily, every day at the same time, on the right side for 3 months.
16096224|NCT02190838|Drug|Metformin|per os 850 mg BID
16096225|NCT02190838|Drug|Melatonin|per os 3 mg daily
16096226|NCT02190838|Drug|Dacarbazine|IV 1 hour 1000 mg/m^2 once in 28 days
16096227|NCT02190825|Device|NeuGuide device|The NeuGuideTM device is indicated for anchoring sutures to ligaments of the pelvic floor
16096228|NCT02190812|Device|Forearm supporter|The forearm supporter be use in tennis elbow.
16096229|NCT02190812|Device|Grip ball|
16096230|NCT02190799|Biological|Convalescent plasma|Convalescent plasma from patients who recently recovered from MERS-CoV, HCWs who had potential exposure and subjects who are willing to donate plasma and have their blood tested for anti MERS-CoV serology and RT-PCR after obtaining their consent
16096231|NCT02190786|Drug|KUX-1151|
16096232|NCT02190760|Drug|Dexamethasone|
16096233|NCT02190760|Drug|Bupivacaine|
16096234|NCT02190747|Drug|Palovarotene|Palovarotene will be taken orally once daily at approximately the same time each day. Powder filled hard gelatin capsules will be opened and the contents added onto specific food.
16096235|NCT02190747|Drug|Placebo|
16096236|NCT02190734|Other|Sitting in wheel chair|Placebo/control intervention- No treatment, sitting in a wheelchair for 30 minutes
16096237|NCT02190734|Other|Gait training on treadmill|Walking on a treadmill with or without body weight support during 30 minute treatment
16096238|NCT02190734|Other|Gait training overground|Walking overground with or without body weight support during 30 minute treatment
16096239|NCT02190721|Drug|tbo-filgrastim|5 μg/kg
16096240|NCT02190708|Drug|PQ912|from day2 up to day6 twice daily oral dose of PQ912
16096241|NCT02190708|Drug|Midazolam|single oral dose on day1 and day 6
16096242|NCT02190708|Drug|Omeprazole|single oral dose on day1 and day6
16096243|NCT02190695|Drug|Decitabine|20 mg/m2 by vein daily over 1 hour on Days 1-5 of each 28 day cycle.
16096244|NCT02190695|Drug|Carboplatin|AUC 5 by vein over 1 hour on Day 8 of each 28 day cycle.
16096245|NCT02190695|Drug|Arsenic trioxide|0.15 mg/kg by vein over 1 hour on Days 1-5 of each 28 day cycle.
16096246|NCT02190669|Other|exercise|Sprinting, walking on a treadmill, and stationary bicycle riding
16096247|NCT02190643|Behavioral|Cessation counseling with adherence focus|
16096248|NCT02190643|Behavioral|Cessation counseling without adherence focus|
16096249|NCT02190630|Device|Modified Clark Twin Block|The Modified Clark Twin Block is a type of functional orthodontic appliance used to posture the lower jaw forward to treat discrepancies between the upper and lower jaw bones
16096250|NCT02190617|Behavioral|Enhanced Clinic+ Unified Plan + CHW|"Unified asthma management plan and asthma support team coordination: A support team will partner with each patient to develop a single asthma management plan. An EMR will provide a web-based platform for sharing the unified asthma management plan.
~Home visit intervention: Community health workers will provide in-home tailored asthma support and conduct follow-up to support patient actions to improve asthma control based on unified asthma management plan.
~Enhanced clinic intervention: Intervention clinics will implement a multicomponent intervention that will include decision support, audit and feedback, provider and staff education, asthma champions, team-based care, and spirometry, all supported by EMR enhancements and clinic systems redesign."
16096251|NCT02190617|Behavioral|Enhanced Clinic+ Unified Management Plan|"Unified asthma management plan and asthma support team coordination: A support team (clinicians, CHWs and plan care managers) will partner with each patient to develop a single asthma management plan. An EMR will provide a web-based platform for sharing the unified asthma management plan and enhancing communications among care team.
~Enhanced clinic intervention: Intervention clinics will implement a multicomponent intervention that will include decision support, audit and feedback, provider and staff education, asthma champions, team-based care, and spirometry, all supported by EMR enhancements and clinic systems redesign."
16096252|NCT02190617|Behavioral|CHW Home Visit Only|-Home visit intervention: Community health workers will provide in-home tailored asthma support: assess asthma self-management knowledge and skills, conduct a home environmental assessment focused on asthma triggers, and conduct follow-up visits to support patient actions to improve asthma control based on unified asthma management plan.
16096253|NCT02190604|Drug|Placebo|Capsule- oral dose
16096254|NCT02190604|Drug|QBW251|Capsule - oral dose
16096257|NCT02190565|Dietary Supplement|Food supplement|Randomized double-blind, placebo-controlled
16096258|NCT02190552|Device|EmboTrap® Revascularization Device|
16096259|NCT02190539|Other|Homeopathic treatment|Remedies are sold over the counter without a physician prescription (approved by the Israeli Ministry of Health). No toxicity or side effects are expected to be observed, potencies (dilutions) of substances beyond 7C (7 dilutions, each 1:100) do not contain a sufficient number of molecules of the original material to be pharmacologically active. Since the remedies being used in this trial are diluted at 30c and 200c, levels that are way beyond Avogrado's number, so no original material is expected to be found. This fact was verified utilizing high pressure liquid chromatography (HPLC) method. Due to those facts, most scientists do not accept that these remedies have any biological effects and consign any positive response to the placebo effect.
16096260|NCT02190526|Drug|Mesalazine(asacol 800 mg)|
16096261|NCT02190526|Drug|Amitriptyline|
16096262|NCT02190526|Drug|placebo like asacol|
16096263|NCT02190526|Drug|placebo like amitriptyline|
16096264|NCT02190500|Other|Mobile Stroke Unit Management|Mobile Stroke Unit is a standard 12' Houston Fire Department ambulance equipped with point of care lab, CT scanner and staffed by a Vascular Neurologist, Registered Nurse with acute stroke and research experience, CT Technician and a Registered EMT-P. The MSU is dispatched in coordination with Houston, Bellaire and West University fire department/emergency medical services.
16096265|NCT02190474|Behavioral|Mindfulness Group|Participants will attend weekly 1-2-hour group sessions (of 6-8 persons) led by a trained expert based on the working MBSR protocol. The weekly sessions will be scheduled in a time mutually convenient for participants and their parent/guardian that will accompany them to each group session. The MBSR group sessions will take place at the Yale School of Medicine.
16096266|NCT02190461|Procedure|Early Respiratory Rehabilitation Program|
16096267|NCT02190461|Procedure|Conventional Respiratory Rehabilitation Program|
16096268|NCT02190448|Dietary Supplement|study herbal tea|3-5 cups, 8oz tea daily for 4 weeks
16096269|NCT02190448|Dietary Supplement|herbal placebo tea|3-5 cups, 8oz each daily for 4 weeks
16096270|NCT02190435|Device|Stryker ADAPT computer-assisted navigation|Adaptive Positioning Technology for Gamma 3
16096271|NCT02190435|Device|Conventional technique|Conventional Technique
16096272|NCT02190409|Device|Dental implant|This longitudinal human clinical trial is designed to measure implant stability with the resonance frequency analyzer (Osstell, Integration Diagnostics AB, Sweden) at time of implant placement and up to 4 weeks post placement. delivered. No further follow-up will be done with the resonance frequency approach
16096273|NCT02190383|Behavioral|Habit Reversal Training|awareness training, competing response training
16096274|NCT02190370|Behavioral|Resources activation|
16096275|NCT02190357|Drug|Rifaximin|Rifaximin is an antibiotic that is virtually non-absorbed after oral administration and exhibits broad spectrum antimicrobial activity against both aerobic and anaerobic gram-positive and gram-negative microorganisms within the gastrointestinal tract.
16096276|NCT02190344|Device|8-channel paddle coil|MRI Coil
16096277|NCT02190331|Other|Interventional program postural correction training|The postural correction training program was applied in the last 15-20 minutes of each PE class, twice a week, with the supervision and help of the PE teacher.
16096278|NCT02190331|Other|Control Group physical education classes|Only performed the physical education classes
16096279|NCT02190318|Drug|Losartan|
16096280|NCT02190318|Drug|spirolactone|
16096281|NCT02190318|Other|blank control|
16096282|NCT02190305|Device|Multiplo HBc/HIV/HCV and Reveal HBsAg|All subjects tested with both investigational devices, plus with algorithms of approved assays for HIV and hepatitis B and C.
16096283|NCT02190279|Drug|18F DCFBC|Each subject will receive a single intravenous (i.v.) dose of 18F DCFBC by bolus injection at a rate of approximately 1 ml/3-5 sec.
16096284|NCT02190279|Drug|Sodium (Na)18F positron emission tomography (PET)/computed tomography (CT)|
16096285|NCT02190227|Device|Tumor RDA biopsy|Tumor RDA score measured from an FNA biopsy after cycle 1-2-3 of neoadjuvant chemotherapy and after first cycle of second chemotherapy agent if palpable tumour present.
16096286|NCT02190201|Device|videolaryngoscope|a kind of videolaryngoscopes, which are widely used in difficult airways.
16096287|NCT02190201|Device|Direct laryngoscope|A kind of traditional laryngoscopes
16096288|NCT02190188|Device|Wedge Insole 5mm|
16096289|NCT02190188|Device|Knee Brace|
16096290|NCT02190162|Drug|Tantum Verde® mouthwash|
16096291|NCT02190162|Other|Placebo mouthwash|Mouthwash with placebo solution
16096292|NCT02190149|Biological|ADVATE (Antihemophilic Factor [Recombinant])|
16096293|NCT02190149|Biological|RIXUBIS (Coagulation Factor IX [Recombinant])|
16096294|NCT02190136|Other|Protein whole foods|Protein-rich whole foods consumed at 20-30 grams of protein at each of 4-6 meals per day
16096295|NCT02190136|Other|Protein Resistance Exercise Training|Protein rich whole foods diet and resistance training 3 times per week for 11 weeks
16096296|NCT02190136|Other|Protein Stretching/Yoga Training|Protein-rich whole foods diet of 20-30 grams of protein at each of 4-6 meals per day with stretching/yoga training 3 times per week for 11 weeks
16096297|NCT02190123|Drug|ACS patients treated with OAP|Patients with ACS who have been initiated and treated with ticagrelor and other oral antiplatelets.
16096298|NCT02190097|Other|Paleolithic diet|see procedures section for more details
16096299|NCT02190097|Other|American Diabetes Association diet|see procedures section
16096300|NCT02190084|Device|Neurostar repetitive transcranial magnetic stimulator|The active procedure will stimulate at 120% motor threshold for 4 seconds at a frequency of 10 Hz, with an inter-train interval of 26 seconds for a total of 3,000 pulses. 20 treatment sessions are given over a four week period.
16096301|NCT02190058|Drug|DS-1971a|suspension
16096302|NCT02190058|Drug|placebo|placebo matching DS-1971a
16096303|NCT02190045|Other|Wii-Fit exercises|Wii-Fit exercises will be administered for 45 minutes 3 days of the week for 8 weeks
16096304|NCT02190045|Other|Cognitive remediation exercises|Cognitive Remediation exercises will be administered for 45 minutes 3 days of the week for 8 weeks
16096389|NCT02189421|Device|ultra-slim upper endoscope|Direct peroral cholangioscopy by using an ultra-slim upper endoscope without assisting accessories
16096390|NCT02189408|Biological|Platelet rich plasma|
16096305|NCT02190032|Device|Mallinckrodt endotracheal tube with a modified angle|At sniffing position, the distal tip of a double-lumen tube is located at the patient's cricoid cartilage level and then the tube is bent at the intersection point of oral axis and the pharyngolaryngeal axis with an angle between the two axes.
16096306|NCT02190032|Device|Mallinckrodt endobronchial tube with a conventional angle|Inserting a manufacturer-provided conventional-angled tube
16096307|NCT02190019|Device|Neurostar repetitive transcranial magnetic stimulator|The active procedure will stimulate at 120% motor threshold for 4 seconds at a frequency of 10 Hz, with an inter-train interval of 26 seconds for a total of 3,000 pulses. 10 treatment sessions are given over a two week period.
16096308|NCT02189980|Other|Aromatherapy blend|A blend of 45% ginger, 25% peppermint, 5% spearmint, and 25% cardamom essential oils
16096309|NCT02189980|Other|Duration of effectiveness of the essential oil blend|Evidence of effectiveness of tested aromatherapy blend in reducing symptoms of post-operative nausea as measured by patient self-report using Likert-type scale measure immediately to one-day post-operative.
16096310|NCT02189980|Other|Participant comfort using the nasal clip delivery system|Comfort of participants using nasal clip delivery system for aromatherapy will be measured by self-report using Likert-type scale immediately to one-day post-operative.
16096311|NCT02189967|Radiation|conventional fractionation|In this treatment arm patients will receive radiotherapy with the currently used conventional fractionation schedule i.e. 5 fractions per week, 2 Gy single dose.
16096312|NCT02189967|Radiation|accelerated fraction|In this treatment arm patients will receive radiotherapy with an accelerated fractionation schedule i.e. 7 fractions per week, 2 Gy single dose.
16096313|NCT02189954|Procedure|The placement according to the manufacturer's instructions|Before insertion the laryngeal mask used in daily routine (Laryngeal Mask Unique®(LMU)) was lubricated with a water-based gel and the cuff was completely deflated. After induction when BIS values were between 40 and 60 and sufficient chin relaxation was obtained for patients weighing less than 50 kg no. 3 LMU, for those between 50-90 kg no. 4 and for patients above 90 kg no. 5 LMU was inserted by an anesthetist with more than five years experience
16096314|NCT02189954|Procedure|Cuff inner pressure was held below 44 mmHg|cuff pressure limitation (Group Pressure Limiting (PL), n=45) cuff inner pressure was held below 60 cmH2O (44 mmHg)
16096315|NCT02189941|Drug|Deferiprone sustained-release|Deferiprone sustained-release tablets
16096316|NCT02189941|Drug|Deferiprone immediate-release|Deferiprone immediate-release tablets
16096317|NCT02189928|Device|Lower limb tourniquet|"Lower limb tourniquet will be put on half thigh. The protocol will include 4 cycles of inflation cuff 110 mm Hg above systolic blood pressure followed by 4 cycles of deflation in between.
~The total duration of per-CID protocol will be 40 minutes (4 phases of 5 minutes inflations' of and 4 phases of 5 minutes deflations')."
16096318|NCT02189928|Other|Usual care|
16096319|NCT02189915|Drug|Creatine monohydrate|
16096320|NCT02189902|Dietary Supplement|4000 IU/d D3 over 12 weeks|
16096321|NCT02189902|Dietary Supplement|7000 IU/d D3 over 12 weeks|
16096322|NCT02189889|Drug|EPO|The treatment group will receive up to three doses of EPO 300U/kg. The first dose of study medication will be administered up to 28 days before the day of surgery and the second will be administered 1-7 days before the day of surgery. These first two doses will be given at least 7 days apart. A third dose may be administered two days following surgery. All 3 doses will be administered per surveillance strategy guidelines.
16096323|NCT02189889|Drug|Feraheme|Supplementation with Feraheme, 510mg delivered as an IV infusion, will be given following the first two preoperative doses of EPO.
16096324|NCT02189876|Behavioral|Standard of Care|All participants will be provided a STD/HIV pre-test counseling session. This session will be provided by either certified project staff or clinical staff at a Los Angeles clinic that conduct State of CA Fam Pact services for patients who are of child bearing age, including our current study partner St. John's Well Child and Family Center and our former study partner, JWCH (John Wesley Community Health) Institute-Wesley Health Center Clinics. Following the counseling session, the participant will be asked to provide a sample of urine to test for Chlamydia and Gonorrhea.
16096325|NCT02189876|Behavioral|FemAALES|Women will attend 9 small group sessions over 4 weeks. Three of these sessions will focus specifically on participants learning to use a computer, set up an email account, communicate with the team and the group using the Internet, and developing a prevention message for display on project website and social media accounts. The other 6 sessions will include discussions on the following topics: being a Black woman in American, Black history, assessing personal health, changing current behaviors, HIV/AIDS information, and education, self-empowerment, communication skills, reasons to change, and goal setting.
16096326|NCT02189863|Device|Lotrafilcon B MF|Multifocal contact lenses worn in both eyes
16096327|NCT02189863|Device|Lotrafilcon B MV|Spherical contact lenses worn with 1 eye corrected for distance and 1 eye corrected for near
16096328|NCT02189863|Device|Lotrafilcon B SVD|Spherical contact lenses worn with both eyes corrected for distance
16096329|NCT02189863|Device|Comfilcon A MF|Multifocal contact lenses worn in both eyes
16096330|NCT02189863|Device|Habitual contact lenses|Contact lenses worn in both eyes per subject's habitual prescription
16096331|NCT02189850|Drug|BLI800 - Dose 1|BLI800 oral solution
16096332|NCT02189850|Drug|BLI800 - Dose 2|BLI800 oral solution
16096333|NCT02189837|Biological|Evolocumab|Administered by subcutaneous injection
16096334|NCT02189837|Drug|Atorvastatin|Administered by mouth
16096335|NCT02189837|Drug|Placebo to Evolocumab|Administered by subcutaneous injection
16096336|NCT02189837|Drug|Placebo to Atorvastatin|Administered by mouth
16096337|NCT02189824|Biological|Partially HLA-matched unrelated donor cells|
16096338|NCT02189811|Biological|IPV|IPV at birth, 6, 10, 14 weeks of age and tOPV at 18 and 22 weeks of age
16096339|NCT02189811|Biological|bOPV|bOPV at birth, 6, 10, 14 weeks and tOPV at 18 and 22 weeks of age
16096340|NCT02189811|Biological|bOPV and IPV|bOPV till week 10, bOPV+IPV at 14 and tOPV at 18 and 22 weeks of age
16096341|NCT02189811|Biological|bOPV and IPV and IPV2|bOPV till week 10, bOPV+IPV at 14, tOPV+IPV2 at 18 and tOPV at 22 weeks of age
16096342|NCT02189811|Biological|tOPV|tOPV till 22 weeks of age
16096391|NCT02189395|Drug|NPH and regular insulin|
16096392|NCT02189395|Drug|glargine and humalog|
16096393|NCT02189382|Device|Potassium Oxalate|
16096343|NCT02189798|Device|HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode|HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be implanted in adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss).
16096344|NCT02189798|Device|EAS sound processor|Patients with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) implanted with HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode will be fitted with the EAS sound processor.
16096345|NCT02189772|Drug|Metadoxine extended release|MG01CI
16096346|NCT02189772|Drug|Placebo|Inactive drug
16096347|NCT02189759|Other|Continuous Kangaroo Mother Care to one hour after birth|Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), the infant will be removed from KMC and routine bundling practices will be used. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age.
16096348|NCT02189759|Other|Standard Kangaroo Mother Care to one hour after birth|Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), the infant will receive standard care which may include removal from KMC and use of routine bundling practices. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age.
16096349|NCT02189759|Other|Continuous Kangaroo Mother Care to discharge|Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), the infant will be removed from KMC and routine bundling practices will be used. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age and again at discharge or 24 hours whichever occurs first.
16096350|NCT02189759|Other|Standard Kangaroo Mother Care to discharge|Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), standard treatment will be given which may include removal from KMC and use of routine bundling practices. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age and again at discharge or 24 hours whichever occurs first.
16096351|NCT02189746|Other|Continuous Kangaroo Mother Care to 1 hour after birth|Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible until 1 hour of birth. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), the infant will be removed from KMC and routine bundling practices will be used. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age.
16096352|NCT02189746|Other|Standard Kangaroo Mother Care to 1 hour after birth|Infants will receive the standard WHO thermoregulation care of Kangaroo Mother Care for as much as possible until 1 hour of birth, without additional encouragement per study personnel. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. All infants will be resuscitated as usual per Neonatal Resuscitation Program guidelines and hospital standard practices. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), the infant will receive standard care which may include removal from KMC and use of routine bundling practices. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age.
16096353|NCT02189746|Other|Continuous Kangaroo Mother Care to discharge|Infants will receive the standard WHO thermoregulation care with encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from one hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), the infant will be removed from KMC and routine bundling practices will be used. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age and again at discharge or 24 hours whichever occurs first.
16096354|NCT02189746|Other|Standard Kangaroo Mother Care to discharge|Infants will receive the standard WHO thermoregulation care without additional encouragement from study personnel to keep infant in Kangaroo Mother Care for as much as possible from 1 hour after birth to discharge. In KMC, the naked newborn infant with cap and diaper will be placed prone on mom's bare chest with blanket covering the infant's back. The nursing staff will supervise mother-infant when mother is sleeping with infant in KMC. If infant becomes hyperthermic (>38 degrees Celsius), standard treatment will be given which may include removal from KMC and use of routine bundling practices. The infant's temperature will be taken via axillae with a digital thermometer at one hour of age and again at discharge or 24 hours whichever occurs first.
16096355|NCT02189733|Biological|Caplacizumab|Comparison of reconstituted lyophilised formulation versus liquid formulation of caplacizumab
16096394|NCT02189382|Other|Water|
16096889|NCT02185729|Other|Saline (control)|Infusion of 0.9% normal saline
16096356|NCT02189720|Drug|Amifampridine Phosphate|"Dosage form: tablets containing the equivalent of 10 mg amifampridine per tablet.
~Amifampridine Phosphateis given based on Investigator assessment of optimal neuromuscular benefit. Doses range from 30 mg to 80 mg, divided into doses taken 3 to 4 times per day, with a maximum single dose of 20 mg."
16096357|NCT02189707|Dietary Supplement|Probiotic Bifidobacterium 1x1010 cfu|Participants who pass the initial screening will enter a 2-week placebo-only run-in period. Participants who successfully complete the run-in period will be randomized to daily supplementation with B. lactis HN019 (1 x 1010 cfu), B. lactis HN019 (1 x 109 cfu), or placebo for 4 weeks.
16096358|NCT02189707|Dietary Supplement|Probiotic Bifidobacterium 1x109 cfu|Participants who pass the initial screening will enter a 2-week placebo-only run-in period. Participants who successfully complete the run-in period will be randomized to daily supplementation with B. lactis HN019 (1 x 1010 cfu), B. lactis HN019 (1 x 109 cfu), or placebo for 4 weeks. One capsule of study product, mixed with provided yogurt, will be consumed once a day.
16096359|NCT02189707|Other|Placebo powder in capsules|Participants will consume placebo capsules only during the 2-week run-in period. After randomization, participants will be administered their assigned study product and will continue on the product for 4 weeks.
16096360|NCT02189694|Device|Single-hormone closed-loop strategy|Variable subcutaneous insulin infusion rates will be used to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) will be used.
16096361|NCT02189694|Device|Dual-hormone closed-loop strategy|Variable subcutaneous insulin and glucagon infusion rates will be used to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) and Glucagon (Eli Lilly and Company) will be used.
16096362|NCT02189694|Device|Insulin pump therapy|Subjects will use conventional pump therapy to regulate glucose levels. Insulin Aspart (Novorapid, Novo Nordisk) will be used.
16096363|NCT02189681|Procedure|Conventional landmark guided midline spinal anaesthesia|Spinal anaesthesia was administered based on conventional landmark based midline approach.
16096364|NCT02189681|Procedure|pre-procedure ultrasound guided L5S1 paramedian spinal|In group P, a portable ultrasound unit was used for initial pre-procedural marking. The L5 S1 interspinous space with best image of the anterior complex (ligamentum flavum dura complex- LFD) and posterior complex (posterior longitudinal ligament- PLL) was obtained. At this selected interspace, and with the probe positioned to obtain the clearest ultrasound image, a skin marker was used to mark the midpoint of the long border of the probe and the midpoints of the short borders of the probe . At the same horizontal level as the midpoint of the long border of the probe, the midpoint of the line drawn between the two short border midpoints of the probe was used as paramedian insertion point for the spinal needle.Spinal anaesthesia is then administered based on these landmarks.
16096365|NCT02189681|Device|spinal anaesthesia|Spinal anaesthesia is administered with appropriate spinal needle
16096366|NCT02189668|Drug|Antibiotics only (Zosyn then Augmentin)|Intravenous and oral antibiotics without surgery Piperacillin/Tazobactam and then Augmentin Cipro/Flagyl if Penicillin allergic
16096367|NCT02189655|Procedure|bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid|Hyperbaric bupivacaine 0.5% 2.5 mL diluting with cerebrospinal fluid was administered intrathecally in 30 seconds
16096368|NCT02189629|Drug|CD5789 (trifarotene)|
16096369|NCT02189616|Behavioral|SMS reminder|send weekly mobile phone short message reminders to the intervention group
16096370|NCT02189616|Other|SMS consultation|told patients to consult qualified asthma nurses by SMS when they need
16096371|NCT02189616|Other|regular care|patients are asked to fill in their paper asthma diary daily for 3 months
16096372|NCT02189603|Biological|Recombinant (E. Coli) Hepatitis E Vaccine|
16096373|NCT02189590|Device|i-gel|Patients randomized to this intervention will have the i-gel placed following induction of general anesthesia. Subsequent tracheal intubation will be performed using the device as a conduit for fiberoptic-guided intubation. Following successful tracheal intubation, the device will be removed.
16096374|NCT02189590|Device|air-Q|Patients randomized to this intervention will have the air-Q placed following induction of general anesthesia. Subsequent tracheal intubation will be performed using the device as a conduit for fiberoptic-guided intubation. Following successful tracheal intubation, the device will be removed.
16096377|NCT02189564|Behavioral|Feedback about good performance|
16096378|NCT02189564|Behavioral|Feedback about good performance + money|
16096379|NCT02189564|Behavioral|Feedback about average performance|
16096380|NCT02189551|Behavioral|Gait training with Lokomat Pro|
16096381|NCT02189551|Behavioral|Gait training with Lokomat Pro FreeD|
16096382|NCT02189538|Dietary Supplement|ω-3 PUFA|The patients are fed as long as the clinically required with the randomly attributed enteral solution.
16096383|NCT02189538|Dietary Supplement|Low fat enteral diet|The patients are fed as long as the clinically required with the randomly attributed enteral solution
16096384|NCT02189512|Other|blood sampling|cases - blood sampling controles - blood sampling
16096385|NCT02189499|Device|AmM FORTITUDE Bioresorbable Drug-Eluting Coronary Scaffold|Placement of the investigational device into the diseased coronary artery to eliminate the vascular stenosis.
16096386|NCT02189473|Radiation|radiotherapy|external beam radiotherapy (5 x 4 Gy versus 10 x 3 Gy)
16096387|NCT02189447|Procedure|Simultaneous Photorefractive Keratectomy and Collagen Cross-linking in patients with keratoconus|Photorefractive Keratectomy followed by Collagen Cross-linking in patients with keratoconus in the same surgical setting
16096388|NCT02189434|Other|Serum procalcitonin lab draws|"Blood will be collected in a 4mL capacity, green top lithium heparin tube. Samples can be drawn from a port with other labs. The samples will be centrifuged and then the plasma/serum will be removed and placed into a screw-capped round bottom plastic vial. Samples will be stored at -20○C until processing. Serum samples will be batch processed for each participant at the conclusion of their study period.
~These draws will be conducted for the sole purpose of this study, and whenever possible, they will be performed at the same time as routine blood draws conducted for medical monitoring to reduce the burden to the patients."
16096890|NCT02185716|Drug|Levobupivacaine 0.25 %|
16096395|NCT02189369|Other|Day 3 embryo transfer|Extraction of endometrial fluid, analysis of prostaglandine and Day 3 embryo transfer
16096396|NCT02189369|Other|Day 5 embryo transfer|Extraction of endometrial fluid, analysis of prostaglandine and Day 5 embryo transfer
16096397|NCT02189356|Behavioral|exercise programme|The study was a prospective randomized trial with a control group (standard care group) and an intervention group, using a repeated measures design. Forty-eight pregnant participants with pregnancy-related LBPP were included in the control group and 48 pregnant participants with pregnancy-related LBPP were included in the intervention (exercise) group
16096398|NCT02189356|Behavioral|standard care|standard pregnancy follow up
16096399|NCT02189343|Drug|ACY-1215 in combination with pomalidomide and dexamethasone|Escalating dose Cohorts to determine a potential Maximum Tolerated Dose to recommend for a dosing schedule.
16096400|NCT02189330|Drug|Tafamidis|20 mg of current commercial formulation.
16096401|NCT02189330|Drug|Tafamidis|12.2 mgA free acid tablet.
16096402|NCT02189330|Drug|Tafamidis|20 mg new soft gelatin capsule.
16096403|NCT02189330|Drug|Tafamidis|4 capsules of 20 mg tafamidis of current commercial formulation.
16096404|NCT02189330|Drug|Tafamidis|4 capsules of 12.2 mg tafamidis of free acid tablet..
16096405|NCT02189317|Drug|Exparel|For the treatment group a total of 40 cc consisting of 20 cc of 1.3% Exparel® and 20 cc of 0.5 % marcaine will be administered to the ACL harvest site, into the periosteum surrounding the distal tibial tunnel site, and in the proximity of the skin incisions. No infiltration of Exparel will be provided intra-articularly.
16096406|NCT02189304|Drug|PT010|PT010; Budesonide, Glycopyrrolate, and Formoterol Fumarate Inhalation Aerosol. Administered as 2 inhalations
16096407|NCT02189304|Drug|PT009|PT009 administered as 2 inhalations
16096408|NCT02189304|Drug|Symbicort Turbohaler|Symbicort Turbohaler taken as 2 inhalations
16096409|NCT02189291|Procedure|Immediate catheter removal|The indwelling catheter will be removed prior to exiting the operating room.
16096410|NCT02189291|Procedure|Post op day 1 catheter removal|For patients assigned to catheter removal on post operative day one, which is the standard of care at this point.
16096411|NCT02189278|Behavioral|Psychosocial Intervention|Telephone-based psychosocial intervention involving six telephone encounters. Each encounter focuses on teaching skills for improving adherence and overcoming barriers to obtaining recommended surveillance.
16096412|NCT02189265|Other|Smoke-free legislation|The intervention under study is the ban on smoking in workplaces, and in bars and restaurants implemented in the Netherlands on January 1st, 2004 and July 1st, 2008, respectively.
16096413|NCT02189252|Drug|Epanova|
16096414|NCT02189252|Drug|Lovaza|
16096415|NCT02189239|Drug|Zeller Entspannung film coated tablet|
16096416|NCT02189239|Drug|Placebo|
16096417|NCT02189239|Other|No Treatment|
16096418|NCT02189226|Device|Endoscopic submucosal dissection (ESD) with or without probe-based confocal laser endomicroscopy (pCLE)|Before ESD, the lesion will be observed either by pCLE or by CE to determine proximal and distal margin of the lesion. In the pCLE group, after injection of intravenous fluorescein, the lesion will be observed using a flexible confocal miniprobe. In the CE group, the lesion will be observed conventionally under white light after spraying indigocarmine directly via the forceps channel. Marking dots will be placed on both margins using needle knife. Then several dots will be marked on the surrounding normal mucosa 5 mm from the tumor with Argon plasma coagulation. After injection of saline solution with epinephrine into the submucosa, an initial cut will be made with needle knife outside the line of surrounding marks. An insulation-tipped (IT) knife will be inserted into initial cut, and electrosurgical current will be applied to complete the incision around the tumor. After the circumferential cut, the submucosa will be dissected with the IT knife.
16096419|NCT02189213|Drug|Sertraline|Sertraline will be administered to treat anxiety disorders in children and adolescents.
16096420|NCT02189200|Dietary Supplement|oat bran - 40g|oat bran - 40g per day
16096421|NCT02189200|Dietary Supplement|refined rice flour- 40g|refined rice flour - 40g per day
16096422|NCT02189187|Behavioral|Mindfulness|
16096423|NCT02189187|Behavioral|Psychoeducation|
16096424|NCT02189174|Drug|CLR457|
16096425|NCT02189161|Device|Radiofrequency Ablation (Barrx™)|Anal canal RFA is performed to the full anal canal, 3 cm above the dentate line to the anocutaneous line proximal to the verge. The procedure entails Barrx60 ablation device, introducing the device into the anus through the anoscope, placing the electrode surface in contact with the target tissue and delivering 3 bursts of energy in rapid succession at an energy density setting of 12 J/cm2.
16096426|NCT02189135|Device|Telemedicine|The glucometer acts by automatically uploading any glucose readings to an online portal. A summary of the patient's glycaemic and metabolic control, self-management skills as well as compliance to other key measures such as eye examination, screening for microvascular complications would also be provided if available. All patients in this intervention arm would be given a system-driven guidance on when to test their blood glucose based on their disease status, medication regimen, and time of poorest control so that the most useful, patient specific blood profile can be created and used for future self-management coaching for patient
16096427|NCT02189122|Drug|Bradykinin|Bradykinin will be given intravenously in graded doses. Each dose will be given for 15 minutes.
16096428|NCT02189122|Drug|Aspirin 81 mg|Subjects will take Aspirin 81 mg per day for five days.
16096429|NCT02189122|Drug|Aspirin 162 mg|Subjects will take aspirin 162 mg per day for 5 days.
16096430|NCT02189122|Drug|NHP544-C 81 mg|Subjects will take NHP544C 81 mg per day for five days.
16096431|NCT02189122|Drug|NHP544C 162 mg|Subjects will take NHP544C 162 mg once a day for five days.
16096432|NCT02189122|Drug|Placebo|Subjects will take matching placebo for five days.
16096433|NCT02189109|Drug|NVX-108|0.2% emulsion administered i.v.
16096434|NCT02189096|Other|NEWS and Sepsis Screening|Each Paramedic crew will continue to routinely document patient observations in an electronic Patient Report Form (ePRF) on every patient encounter. These physiological parameters will be used to calculate NEWS and screen for Sepsis (2 or more modified SIRS criteria and suspicion of infection). The NEWS will be available to the paramedic crew.
16096489|NCT02188719|Drug|Acetaminophen|Pre-medication for single dose darTreg infusion (Cohorts 2 - 4). 650mg of acetaminophen will be administered intravenously or by mouth 30-60 minutes prior to the darTreg infusion.
16096435|NCT02189096|Other|Point of care lactate measurement|Each Paramedic crew will continue to routinely document patient observations in an electronic Patient Report Form (ePRF) on every patient encounter. These physiological parameters will be used to calculate NEWS and screen for Sepsis (2 or more modified SIRS criteria and suspicion of infection). If NEWS is greater than or equal to 4 or the patient screens positive for Sepsis, then a Lactate will be measured on the CG4+ i-STAT cartridge.
16096436|NCT02189083|Drug|TSD|"TSD is composed of 15 individual Chinese medicines: Astragalus Membranaceus, Semen Coicis, Poria, Curcuma longa L, and Fritillaria Thunbergii Miq, Cassia twig, Pollen typhae, Resina draconis, Lithospermum erythrorhizon, Halloysitum Rubrum, Rhizoma Corydalis processed with vinegar, Hirudo, Calcined corrugated sub , Oyster Shell and Laminaria Japonica Aresch.
~High dose (127g) or Low dose (69g) TSD decoction boiled as 200ml per bag; 2 bags per day, 6 days per week; Orally in-take one bag of TSD decoction in morning and another in evening after meal; The whole treatment lasts for 16 weeks."
16096437|NCT02189057|Other|AssureRx GeneSight genotyping results|
16096438|NCT02189057|Other|Treatment as usual|
16096439|NCT02189044|Other|Pilates Exercise|"The training through the Pilates exercises were performed in eleven weeks. Each class consisted of five exercises lasting 40 minutes each lesson.
~During the first four weeks exercises performed were: Cat, Coffee Table, Single legcircle, pelvic movements, contraction of the glutes and closure was performed with posterior chain elongation range.
~In the next four weeks began a new series of exercises, which are: Bridge, Side Table, Bridge hip roll with legextension, Abdominal - halfhollup, obliques, and ultimately Stretching - Series of William's.
~In the last four weeks of training proposed a new series of exercises involving: Beaststroke, Support heel Bridge - hip roll with leg extension, and Hundred Squats with bat on the wall."
16096440|NCT02189031|Device|Tactor array|
16096441|NCT02189031|Device|Bypass Tactor|
16096442|NCT02189018|Other|Active Exercise|Active exercise on a treadmill
16096443|NCT02189018|Other|Neuromuscular electrical stimulation|Neuromuscular electrical stimulation
16096444|NCT02189018|Other|Weight loss and active exercise|Weight loss and active exercise on a treadmill
16096445|NCT02189018|Other|Ad lib activity at home|Ad lib activity at home
16096446|NCT02189005|Dietary Supplement|Study dietary supplement (PreCrea 600 mg capsules)|Study dietary supplement (PreCrea 600 mg capsules) will be given to subjects twice daily 30 mins before food for 90 days along with life style modification.
16096447|NCT02189005|Dietary Supplement|Placebo|
16096448|NCT02188966|Device|Geographic Information System|"GIS data is delivered by SimaTech Enterprise System communicating via the mobile network and TETRA (in Denmark called SINE). It is developed as a Java Enterprise application and is executed on a JBOSS application platform"
16096449|NCT02188953|Drug|ACCS100|ACCS100 is made from Hydrated Sodium Calcium Aluminosilicate, which is a substance generally recognized as safe by the U.S. FDA.
16096450|NCT02188953|Drug|Calcium carbonate placebo|
16096451|NCT02188940|Behavioral|Dietary|The dietary therapy will be performed every 15 days, totaling 6 sessions of 60 minutes each by a dietitian. Patients will be advised to follow restricted-calorie diet based on the hypocaloric dietary guidance, multiplying the patient's weight by 20 to 25 calories. The Nutwin ® program will be used to structure the patient's diets, based on 24 hours food record and calories tables. Throughout the program, issues related to food control, the benefits of following a balanced diet and the changing food habits will be discussed.
16096452|NCT02188940|Behavioral|Education Program|The education program will consist of 4 classes lasting 6 hours at the beginning of the interventions, in which issues related to asthma and physical activity will be discussed. Presentations and group discussions will be carried out, including information about asthma pathophysiology, medication and peakflowmeter skills, self-monitoring techniques, environmental control, benefits and current recommendations of physical activity.
16096453|NCT02188940|Behavioral|Behavioral Therapy|The Behavioral therapy will be performed every 15 days, totaling 6 sessions of 60 minutes each by a psychologist. Sessions of group dynamics will be performed to increase the patient adherence in a weight loss program using behavior modification techniques, such as self-management, motivational strategies, positive reinforcement and relapse prevention. Relaxation techniques, experiences and patient's report will also be used.
16096454|NCT02188940|Other|Exercise Training|The aerobic training will be performed on a treadmill and a bike (or an elliptical), twice a week, totaling 24 sessions of 60 minutes each. The initial intensity will be 50% to 60% of VO2 max reaching a maximal 75% of VO2 max and the progression will take place according to the level of effort (Borg) in the last two sessions. Patients will be advised to walk outside at least twice a week for 30 minutes and write down their activity in a diary. Furthermore, they will be given an accelerometer in week 6 to record their daily steps. The resistance training will consist of exercises for the upper and lower limbs. Initially, the patients will perform 2 sets of 10 repetitions with load of 50% to 70% of 1-RM and the progression will take place in the number of repetition, and then in the load.
16096455|NCT02188940|Other|Stretching and Breathing exercise|"Breathing exercise will consist of 3 exercises adapted from yoga's breathing technique (kapalabhati, uddhiyana and agnisara) twice a week, totaling 24 sessions of 30 minutes each. Every exercise will be performed in sets of 3 (2 minutes each) with 60 seconds of rest between them. The stretching will consist of stretching exercises for the major muscle groups in 3 sets of 10 seconds each. The program will be performed twice a week, totaling 24 sessions of 30 minutes each.
~*Both breathing and stretching exercises will be performed as placebo to ensure the same duration of treatment between the two groups."
16096456|NCT02188927|Other|Implementation of ANL|Advance Notification Letter will be send two weeks before Standard Invitation for screening colonoscopy
16096457|NCT02188927|Behavioral|No included ANL|Sending Standard Invitation only six weeks before planned screening colonoscopy
16096458|NCT02188914|Radiation|Positron emission tomography scan|
16096459|NCT02188914|Other|Magnetic resonance imaging|
16096460|NCT02188901|Other|Sonazoid-enhanced ultrasonography|Sonazoid (perflubutane) [GE healthcare]
16096461|NCT02188888|Drug|esmolol|Strict heart rate control: esmolol at any dose to maintain heart rate between 95 and 80 bpm
16096462|NCT02188875|Behavioral|SMS Text Messages & Fitbit One|The primary aim was to test text-messaging in its basic form to prompt physical activity. A secondary aim was to examine the effects of the Fitbit One.
16096463|NCT02188875|Behavioral|Fitbit One Only|Active controls received a Fitbit One to facilitate self-monitoring (and no text messages)
16096464|NCT02188849|Other|Resistance exercise training|All participants will be subjected to resistance training of upper and lower limbs, using elastic bands and tubing and free weights. Training will be calibrated at 60% of one repetition maximum for each muscle group with three sets of 15 repetitions with one minute rest between each set. All exercises will be additionally calibrated to be of moderate intensity according to the Borg scale. The exercise load will be adapted according to the progression of each participant.
16096465|NCT02188849|Drug|Creatine|Creatine powder 5 g day
16096466|NCT02188836|Device|Electromagnetic stimulation|Electromagnetic stimulation with a new device produced by the investigators for this study.
16096467|NCT02188836|Device|Sham stimulation|This is a device that look exactly the same to the electrostimulation device, but that does not generate the electromagnetic field. It is a placebo device.
16096468|NCT02188823|Behavioral|Low carbohydrate diet|
16096469|NCT02188810|Biological|PAL|Single dose administered intramuscularly.
16096470|NCT02188810|Biological|TIV|Single dose administered intramuscularly .
16096471|NCT02188797|Behavioral|Group MI risk reduction program|
16096472|NCT02188784|Drug|Polysaccharide Iron Complex 150 mg|Oral Iron
16096473|NCT02188784|Drug|Placebo (for Polysaccharide Iron Complex)|Sugar capsule designed to mimic Polysaccharide Iron Complex.
16096474|NCT02188771|Device|intra-articular administration of RegenoGel-SP or hyaluronic acid (HA)|Intra-articular Injection: single injection of RegenoGel SP or 3 injections of HA
16096475|NCT02188758|Other|Adults - CFPE Treatment|Hospitalization for comprehensive treatment of CF pulmonary exacerbation, including intravenous (IV) antibiotics, nutritional assessment and support, airway clearance of mucus, use of inhaled mucolytic agents and bronchodilators, glycemic control with insulin, and psychosocial support.
16096480|NCT02188732|Behavioral|CBHH+AT|"Community Based Health Home + Automated Telehealth (CBHH+AT):
~Community-Based Health Home (CBHH) PLUS Automated Telehealth: a wireless telehealth device programmed with psychiatric content corresponding to the primary psychiatric diagnosis, and medical content tailored to the primary medical diagnosis. Daily interactive sessions last 5-10 min. Branching logic tailors questions or feedback to the user's responses (e.g., if a participant endorses medication nonadherence, a question appears asking why medications were not taken). The device automatically provides specific instructions to participants demonstrating signs of high risk."
16096481|NCT02188732|Behavioral|CBHH+SMT|Illness Management and Recovery (IMR) for psychiatric illness combines (1) psychoeducation, which improves knowledge about mental illness management, (2) behavioral tailoring, which improves medication adherence, (3) relapse prevention training, which decreases relapses and rehospitalizations, and (4) coping skills training, which reduces distress related to symptoms. Illness Management and Recovery (I-IMR) by adding chronic medical illness self-management to psychiatric illness self-management. For each psychiatric self-management skill module, there is a corresponding medical illness self-management training component using established methods in self-management of common chronic health conditions (e.g., diabetes, hypertension, congestive heart failure, chronic obstructive pulmonary disease, etc.).
16096482|NCT02188732|Behavioral|CBHH|Community-based Health Home (CBHH): Each team has a staff-to-participant ratio of approximately 1:12, with each team serving approximately 120 participants with SMI using person-centered planning and recovery-oriented, flexible service models. Each team provides mobile outreach and includes a team leader; a peer counselor; a psychiatric nurse coordinator; a clinical care coordinator; specialists in substance abuse (dual diagnosis), community integration, rehabilitation, employment, and housing; and a medical nurse practitioner (MNP) and a health outreach worker (HOW).
16096483|NCT02188719|Biological|Anti-Thymocyte Globulin - Rabbit|Liver transplantation/Treg-supportive immunosuppression (IS) treatment. Subjects will be given a dose range of 3.0-4.5 mg/kg total, in divided doses of 1.5 mg/kg/day. Subjects who meet eligibility criteria for Thymoglobulin® administration will be given 1.5 mg/kg intravenously (IV) on post-operative day 3, within 72 hours of transplantation. Additional doses of 1.5 mg/kg IV will be administered until CD3 count is <50/mm^3 or when the maximal dose of 4.5/mg/kg has been given.
16096484|NCT02188719|Biological|darTreg Infusion|A single dose darTreg infusion (Cohorts 2 - 4) will be received as per protocol.
16096485|NCT02188719|Drug|Everolimus|Liver transplantation/Treg-supportive immunosuppression (IS) treatment. Subjects meeting eligibility criteria for Treg-supportive IS regimen will begin EVR no sooner than 30 days after liver transplantation and no later than 44 days after transplantation; with target trough levels of 6-8 μg/L.EVR target trough levels will be further reduced to 4-6 μg/L 24 - 26 weeks after transplantation.
16096486|NCT02188719|Drug|Tacrolimus|"Liver transplantation/Treg-supportive immunosuppression (IS) treatment. Between 30 and 44 days following transplant: Subjects who are not eliminated by Exclusion Criteria C1 (Protocol Section 14.3.1) will proceed in the study and receive either TAC-based or EVR- based IS, based on eligibility Criteria C2 (Section 4.3.4 )
~TAC-based IS: reduce TAC trough level to 3-8 μg/dL; continue MMF
~EVR-based IS: reduce TAC trough level to 3-8 μg/dL; EVR target trough level of 6-8 μg/dL; decrease then discontinue MMF"
16096487|NCT02188719|Drug|Mycophenolate mofetil|Liver transplantation/Treg-supportive immunosuppression (IS) treatment. 1000 mg total daily dose. MMF will be initiated within 24 hours of transplantation. MMF must be discontinued as soon as target EVR trough levels have been achieved.
16096488|NCT02188719|Drug|Prednisone|Liver transplantation/Treg-supportive immunosuppression (IS) treatment. Solumedrol 500 mg will be given IV on the day of transplantation. Additional Solumedrol will be prescribed according to site-specific standard of care. Oral prednisone should be initiated once oral medication is tolerated.
16096490|NCT02188719|Drug|Diphenhydramine|Pre-medication for single dose darTreg infusion (Cohorts 2 - 4). 25-50mg of diphenhydramine will be administered intravenously or by mouth 30-60 minutes prior to the darTreg infusion.
16096491|NCT02188719|Drug|Anti-Infective Prophylaxis|Intravenous ganciclovir and/or oral Valcyte will be administered for the prophylaxis of cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) for at least six months after liver transplantation.
16096492|NCT02188719|Procedure|Leukapheresis|"Leukapheresis is necessary to ensure collection of adequate numbers of autologous Tregs to support ex vivo expansion of darTregs for infusion after liver transplantation.
~Participants enrolled in Cohorts 3 and 4 will undergo leukapheresis. Participants enrolled in Cohort 2 will have either whole blood collection or leukapheresis for the purpose of isolating autologous Tregs for later manufacture. If a cohort 2 subject has a hemoglobin level >/=10.5 gm/dL, he or she will undergo phlebotomy. If the patient has a hemoglobin level </=10.5 gm/dL and remains eligible for the study, the patient will undergo leukapheresis."
16096493|NCT02188719|Procedure|Blood draws|Blood draws are necessary to carefully and frequently evaluate allograft function after liver transplantation and treatment with Treg-supportive IS as well as after darTreg infusion. Peripheral blood samples will be collected and analyzed per protocol throughout subject participation in this study.
16096494|NCT02188719|Procedure|Liver biopsies|Subjects will have a liver biopsy for this study 12-14 weeks after transplantation. For subjects receiving darTregs, a second biopsy will be performed 7-10 days after darTregs infusion.
16096495|NCT02188719|Procedure|Liver transplantation|Inclusion in this trial is in the setting of subjects defined as having end-stage liver disease and listed for primary solitary liver transplant.
16096496|NCT02188680|Other|Low FODMAPS diet|FODMPAS low diet in patients with IBS and positive breath test for fructose FODMAPS low diet in patients with IBS and negative breath test for fructose
16096497|NCT02188667|Other|Providers of Novel Care|Providers in the treatment group will be asked (1) to complete a series of six online education modules in pain care, (2) will be given access to new patient reported outcomes questionnaire data collected from patients within the electronic health record, (3) asked to review this data and related care recommendations during the patient visit, and (4) asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
16096498|NCT02188667|Other|Providers of Usual Care|Providers in the control group will provide care as usual to patients and will be asked to complete baseline and monthly online surveys related to experiences and satisfaction with providing care to patients with chronic noncancer pain.
16096499|NCT02188654|Drug|Metformin|500mg/day retarded formulation of metformin
16096500|NCT02188654|Drug|Placebo|500 mg/day of placebo tablets
16096501|NCT02188641|Other|Diet|
16096502|NCT02188641|Other|Exercise|
16096503|NCT02188641|Other|Diet and Exercise|
16096504|NCT02188641|Other|Healthy Lifestyle (Control) Group|
16096505|NCT02188628|Device|H-Man|H-man is a portable end-effector planar upper limb robot.
16096506|NCT02188628|Other|Additional Conventional Therapy|Repetitive goals based arm therapy
16096507|NCT02188615|Procedure|Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE|Neo-adjuvant Chemoradiotherapy followed by Mckeown MIE
16096508|NCT02188615|Drug|Cisplatin|only Radical Chemoradiotherapy
16096509|NCT02188615|Device|Mckeown MIE|only Mckeown MIE using thoracoscopy and laparoscopy
16096510|NCT02188589|Device|INEX nasal implant|Treatment group may receive unilateral or bilateral INEX nasal implants (maximum of 4, 2 per side)
16096511|NCT02188576|Drug|high dose TXA|
16096512|NCT02188576|Drug|Low dose TXA|
16096513|NCT02188563|Other|Comprehensive smoking cessation intervention|
16096514|NCT02188563|Behavioral|Enhanced usual care|
16096515|NCT02188550|Drug|everolimus and letrozole|"This is a single arm, non-randomized, open-label study with a combination of everolimus and letrozole once a day dosing . Each cycle would be 28days and patients would be scanned after every 3 cycles for response, until disease progression is documented
~The duration of the study will be until disease progression
~Everolimus and Letrozole will be administered as noted below;
~6.1.1 Dosing regimen
~Dosage : Everolimus Dose: 10 Unit: mg Frequency: daily Route of administration: Orally Dosage : Letrozole Dose: 2.5 Unit: mg Frequency: daily Route of administration: Orally"
16096516|NCT02188537|Drug|Nelfinavir|Nelfinavir 2x 2500 mg p.o. days 1 - 14
16096517|NCT02188537|Drug|bortezomib|Bortezomib 1.3 mg/m2 i.v. or s.c. days 1, 4, 8, 11
16096518|NCT02188537|Drug|Dexamethasone|Dexamethasone 20 mg p.o. days 1-2, 4-5, 8-9, 11-12
16096519|NCT02188524|Other|Exercise|Tai Chi and Compensatory Stepping
16096520|NCT02188511|Other|Group A|90 minutes prior to the bronchoscopy on day 8, the subject will be asked to inhale 10 puffs of a Blu brand e-cigarette (for the nicotine-containing e-cigarette, this is approximately equivalent to < 1 cigarette). At 30 minutes prior to the bronchoscopy procedure if the subject has no adverse effect to the e-cigarette he/she will again be asked to inhale 10 puffs of the Blu e-cigarette.
16096521|NCT02188511|Other|Group B|On days 7 and 8, subjects will be asked to inhale 10 puffs of a Blu brand e-cigarette (90 minutes prior to bronchoscopy on day 8). If the subject has no adverse effect to the e-cigarette he/she will again be asked to inhale 10 puffs of the Blu e-cigarette an hour later (30 minutes prior to bronchoscopy on day 8).
16096522|NCT02188511|Other|Group C|On days 6 through 8, subjects will be asked to inhale 10 puffs of a Blu brand e-cigarette (90 minutes prior to bronchoscopy on day 8). If the subject has no adverse effect to the e-cigarette he/she will again be asked to inhale 10 puffs of the Blu e-cigarette an hour later (30 minutes prior to bronchoscopy on day 8).
16096523|NCT02188511|Other|Group D|On days 5 through 8, subjects will be asked to inhale 10 puffs of a Blu brand e-cigarette (90 minutes prior to bronchoscopy on day 8). If the subject has no adverse effect to the e-cigarette he/she will again be asked to inhale 10 puffs of the Blu e-cigarette an hour later (30 minutes prior to bronchoscopy on day 8).
16096524|NCT02188511|Other|Group E|"On days 4 through 8, subjects will be asked to inhale 10 puffs of a Blu brand e-cigarette (90 minutes prior to bronchoscopy on day 8). If the subject has no adverse effect to the e-cigarette he/she will again be asked to inhale 10 puffs of the Blu e-cigarette an hour later (30 minutes prior to bronchoscopy on day 8).
~Exposure to e-cigarettes will be limited to the nicotine equivalent of 1/2 pack of cigarettes to mitigate the risk of addiction to nicotine."
16096891|NCT02185716|Drug|Levobupivacaine 0.5%|
16096525|NCT02188498|Procedure|Polysomnography|Polysomnography, also called a sleep study, is a test used to diagnose sleep disorders. Polysomnography records your brain waves, the oxygen level in your blood, heart rate and breathing, as well as eye and leg movements during the study.
16096526|NCT02188485|Behavioral|ENGAGE|Up to 10 sessions delivered in the home.
16096527|NCT02188472|Drug|Penicillin V|Penicillin V: 2 x 330mg tablets should be taken twice daily
16096528|NCT02188472|Drug|Trimethoprim|Trimopan: 2 x 100mg tablets should be taken twice daily
16096529|NCT02188472|Drug|Placebo|Placebo: 2 tablets should be taken twice daily
16096530|NCT02188459|Drug|Bupropion|A total of 360 participants will be randomly assigned to one of two treatment conditions: Bupropion 300 mg/day (n = 180) or placebo (n = 180). We will use small-block randomization by site (Penn). A PHQ-9 score of 10 or greater will be used to identify major depression and stratify the randomization on it. Study site (Penn) will be the second of the two stratification variables.
16096531|NCT02188446|Behavioral|Educational programme for smoking and alcohol cessation|5 meetings within 6 weeks containing education and pharmacologic support
16096532|NCT02188433|Behavioral|Quit immediately (QI) / cut down to quit (CDTQ)|Use quit immediately (QI) or cut down to quit (CDTQ) interventions to achieve smoking abstinence
16096533|NCT02188420|Device|Transcranial Magnetic Stimulation (Magstim)|
16096534|NCT02188407|Drug|Sevoflurane|MAC 3-5 V% during surgery
16096535|NCT02188407|Drug|Propofol|Propofol group (P group)- The group anaesthesied with propofol
16096536|NCT02188394|Drug|Anesthetic blockades with bupivacaine|
16096537|NCT02188394|Drug|Isotonic saline injection|
16096538|NCT02188381|Other|Stool Sample and Blood Sample|All subjects will provide a stool sample and a blood sample at baseline. Subjects in NCT02133872 will provide a second stool sample and blood sample at their 3 month visit.
16096539|NCT02188368|Drug|POM|
16096540|NCT02188368|Drug|Steroids|
16096541|NCT02188368|Drug|PLD|
16096542|NCT02188368|Drug|CFZ|
16096543|NCT02188368|Drug|BTZ|
16096544|NCT02188368|Drug|CLA|
16096545|NCT02188368|Drug|CY|
16096546|NCT02188342|Behavioral|HIT|12 HIT exercise sessions in 31 days on a stationary cycle ergometer
16096547|NCT02188316|Device|Jumbo forceps|comparison of different polypectomy devices
16096548|NCT02188316|Device|Hot biopsy forceps|comparison of different polypectomy devices
16096549|NCT02188303|Drug|LY2944876|Administered SC
16096550|NCT02188303|Drug|Placebo|Administered SC
16096551|NCT02188277|Drug|Xeomin|"Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
~Administration route is intramuscular injection into medial (two points) and lateral heads (two points) of gastrocnemius."
16096552|NCT02188277|Drug|Botox®|Administration route is intramuscular injection into medial (two points) and lateral heads (two points) of gastrocnemius.
16096557|NCT02188251|Dietary Supplement|Activamp|
16096558|NCT02188251|Other|Placebo|
16096559|NCT02188238|Other|Saliva Sample Collection|Saliva samples will be collected from healthy volunteers recruited locally. Stimulated whole mouth saliva is collected through stimulation by inert gum, and collecting the saliva by gently spitting into a sterile tube.
16096560|NCT02188225|Procedure|acupuncture|12 sessions acupuncture during 12 weeks (3 sessions weekly), each session lasting 20 minutes
16096561|NCT02188225|Drug|fluoxetine|10 mg/ daily
16096562|NCT02188212|Device|NobelProcera Crown Shaded Zirconia|
16096563|NCT02188186|Drug|Initial triple combination|Initial triple combination arm
16096564|NCT02188186|Drug|Conventional treatment|Conventioanl treament with dose escalation
16096565|NCT02188173|Drug|dexamethasone 700 ㎍ intravitreal implant|Patients who receive dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Diabetic Macular Edema. All decisions regarding treatment are made at the sole discretion of the treating physician in accordance with their usual practices.
16096566|NCT02188160|Drug|KPI-121|KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
16096567|NCT02188160|Drug|Placebo|Subjects randomized to placebo control arms will receive the same bottles containing all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
16096568|NCT02188147|Device|Short Term Wearable Defibrillator|Short-term Wearable Defibrillator (SWD 1000)
16096569|NCT02188121|Drug|Simvastatin|3-hydroxy-3-methylglutaryl-coenzyme (HMG-CoA) reductase inhibitors
16096570|NCT02188121|Drug|Losartan|Angiotensin II receptor antagonist
16096571|NCT02188108|Other|Wisconsin Stone-QOL survey|Patients will complete a health-related quality of life survey at multiple time points at enrollment and at multiple time points thereafter.
16096572|NCT02188082|Drug|IvabRadine hemisulfate Sustained-release Tablets|
16096573|NCT02188082|Drug|placebo|
16096574|NCT02188043|Behavioral|Relay Model|"The Clinical staff hand out and collect lifestyle - questionnaires to admitted patients, and screen by 10 alcohol questions (AUDIT) , and report score to outpatient Alcohol Clinic.
~Based on the questionnaire that the patient filled out, the Alcohol therapist perform a brief Motivational Intervention on patients with an AUDIT score of 8+, focusing the patients alcohol consumption habits and offer an appointment to patients with an AUDIT score of 16+."
16096575|NCT02188030|Other|Group Exercise Program|The participants allocated into the GET Group will receive a general exercise training realized in group of workers. Each training session started with a five minute swarm-up by slowly moving the neck, upper back, shoulder, arms and hands through pain-free range of motion; followed by 30 minutes of stretching and strengthening exercises for neck, upper back, shoulder, arms and hands, performed in the standing posture, sitting or lying. For resistance exercise, will be adopted 3 sets of 10 repetitions with a load of 80% of 1 repetitions maximum. Dumbbells and elastic bands and will be used as accessories to perform the resistance exercises.
16096576|NCT02188030|Other|Individual Exercise Program|"The participants allocated into the IET Group will receive a individual and specific strength training with seven different exercises, based in training programme describe by Andersen et al.3 and Sundstrup et al4.
~During the intervention period, the training intensity were progressively increased according to the principle of periodization and progressive overload5. Dumbbells and elastic bands and will be used as accessories to perform the resistance exercises. Experienced instructors supervised every other training session."
16096577|NCT02188017|Drug|Acthar gel|Given 80 units daily for 10 days, then randomized to receive either 40 or 80 units twice a week
16096578|NCT02187991|Drug|Paclitaxel|either 60 mg/m2 intravenously (IV) on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel plus Alisertib arm) or 90 mg/m2 IV on days 1, 8 and 15 of a 28-day cycle (on Paclitaxel Alone arm)
16096579|NCT02187991|Drug|Alisertib|40 mg BID (twice a day) on days 1-3, 8-10, and 15-17 of a 28-day cycle
16096580|NCT02187978|Other|Early total enteral feeding (ETEF)|In ETEF Group total required volume of fluid will be administered as oral feeds and no intravenous fluid will be given. Feeds will be started at 80 mL/kg and increased till 150ml/kg is attained.
16096581|NCT02187978|Other|Conventional enteral feeding (CEF)|CEF Group will receive some feed and some Intravenous fluids. Feeds will be slowly increased from 20 mL/kg on day 1 till full feeds 150ml/kg is attained on day 6 of life.
16096582|NCT02187952|Behavioral|Behavioral feeding intervention|Behavioral feeding intervention will include escape extinction.
16096583|NCT02187939|Other|Summer science wellness program emphasizing health education pertaining to nutrition, physical activity, and healthy lifestyle.|The enhanced virtual world education (GROOVE+) will be compared to conventional approach (GROOVE). Each program is Monday-Friday, 9:30-3:30, for 3 weeks in the summer.
16096584|NCT02187913|Dietary Supplement|Resistant starch|Each subject will complete 2 testing days (randomized and crossover design). On each of 2 test days, subjects will arrive at the Purdue Clinical Research Center after a 12-h fast and will consume a snack bar containing resistant starch. The test snack bar will be consumed along with a standard meal provided at the start of the test day. A second standard meal that does not contain the snack bar will be consumed four hours later.
16096585|NCT02187900|Drug|Multi-glycoside of Tripterygium Wilfordii HOOK. f. (TWH)|The dosage of 40 mg of Multi-glycoside of Tripterygium Wilfordii HOOK. f. was divided into 2 equal doses at 12-hour intervals for 6 months.
16096586|NCT02187900|Drug|Mycophenolate mofetil (MMF)|Mycophenolate mofetil 1.5mg/day for the treatment of IgAN for 6 months
16096587|NCT02187887|Behavioral|Personalized normative feedback|Participants receive behavioral norms feedback based on their response to items in a baseline survey. Personal responses are presented along with perceptions of other same gender veterans and actual drinking norms of same gender veterans.
16096588|NCT02187874|Procedure|delayed umbilical cord occlusion|
16096589|NCT02187874|Procedure|early umbilical cord occlusion|
16096590|NCT02187874|Drug|Oxytocin|
16096591|NCT02187861|Drug|Venetoclax|Venetoclax will be administered as per the schedule specified under arm description.
16096592|NCT02187861|Drug|Bendamustine|Bendamustine will be administered as per the schedule specified under arm description.
16096593|NCT02187861|Drug|Rituximab|Rituximab will be administered as per the schedule specified under arm description.
16096594|NCT02187848|Drug|SAR408701|Pharmaceutical form: concentrate for solution for infusion Route of administration: intravenous
16096595|NCT02187822|Drug|TPI 287|TPI 287 is an infusion given through veins. Dose escalation will begin at 14 mg/m^2/dose. Dose expansion will begin at the maximum tolerated dose (MTD).
16096596|NCT02187822|Procedure|Fractionated Stereotactic Radiotherapy (FSRT)|The prescription dose will be 25 gray (Gy) in 5 daily fractions delivered to the planning target volume (PTV).
16096597|NCT02187809|Drug|Clobazam|
16096598|NCT02187783|Drug|LEE011|Study drug was provided in 200 mg and 50 mg hard gelatin capsules to be taken orally
16096599|NCT02187770|Device|IMED-4|Non invasive recording electrode used to assess lung fluid
16096600|NCT02187757|Dietary Supplement|Study Dietary Supplement (Prelipid 500 mg capsules)|Study Dietary Supplement (PreLipid 600 mg capsules) will be given to subjects twice daily 30 mins before food for 90 days along with lifestyle modification.
16096601|NCT02187757|Dietary Supplement|Placebo|
16096602|NCT02187744|Biological|PF-05280014|Concentrate for solution for infusion, sterile vial 150 mg, Day 1 Cycle 1 will be a loading dose of 8 mg/kg infused over 90 minutes. Subsequent infusions will follow every 3 weeks (i.e., cycled every 21 days) with a dose of 6 mg/kg administered over 30 to 90 minutes depending on tolerability, maximum of 6 cycles.
16096603|NCT02187744|Drug|Taxotere®|Injection concentrate single-dose vials containing 20 mg (0.5 mL) or 80 mg (2 mL), each mL contains 40 mg docetaxel (anhydrous) and 1040 mg polysorbate 80, The starting dose of Taxotere® (docetaxel) will be 75 mg/m2 administered intravenously over 60 minutes every three weeks on Day 1 of each cycle (i.e., every 21 days), maximum 6 cycles.
16096604|NCT02187744|Drug|Paraplatin®|Lyophilized powder, single-dose vials containing 50 mg, 150 mg, and 450 mg of Carboplatin for administration by intravenous infusion (each vial contains equal parts by weight of Carboplatin and mannitol), starting dose 6 AUC, over 15 minutes or longer every three weeks on Day 1 of each cycle (i.e., every 21 days), maximum 6 cycles.
16096605|NCT02187744|Biological|Trastuzumab-EU|Concentrate for solution for infusion, sterile vial 150 mg, Day 1 Cycle 1 will be a loading dose of 8 mg/kg infused over 90 minutes. Subsequent infusions will follow every 3 weeks (i.e., cycled every 21 days) with a dose of 6 mg/kg administered over 30 to 90 minutes depending on tolerability, maximum 6 cycles.
16096606|NCT02187744|Drug|Taxotere®|Injection concentrate single-dose vials containing 20 mg (0.5 mL) or 80 mg (2 mL), each mL contains 40 mg docetaxel (anhydrous) and 1040 mg polysorbate 80, The starting dose of Taxotere® (docetaxel) will be 75 mg/m2 administered intravenously over 60 minutes every three weeks on Day 1 of each cycle (i.e., every 21 days), maximum 6 cycles.
16096607|NCT02187744|Drug|Paraplatin®|Lyophilized powder, single-dose vials containing 50 mg, 150 mg, and 450 mg of Carboplatin for administration by intravenous infusion (each vial contains equal parts by weight of Carboplatin and mannitol), starting dose 6 AUC, over 15 minutes or longer every three weeks on Day 1 of each cycle (i.e., every 21 days), maximum 6 cycles.
16096608|NCT02187718|Procedure|Sentinel Node Procedure under Local Anaesthesia|
16096609|NCT02187718|Procedure|Sentinel Node Procedure under General Anaesthesia|
16096610|NCT02187705|Drug|Telmisartan tablets|All patients were treated with different doses of telmisartan for 14 days
16096611|NCT02187692|Behavioral|MCT|The meta-cognitive training (the MCT) consists of eight structurized psychological therapy modules that provides basic knowledge about cognitive biases that are associated with schizophrenia and it provides the sklills how to overcome negative consequences of the biases. The MCT includes: Module 1 manages self-serving bias (i.e. external-personal attribution for failure, internal attribution for positive events); Module 2 and 7 target the jumping to conclusion; Module 3 and 7 concern beliefs flexibility and bias against disconfirmatory evidence; Module 4 and 6 target deficits in theory of mind; Module 5 is devote to ameliorate the cognitive over-confidence in false memories; Module 8 deals with depressive thinking style.
16096612|NCT02187679|Drug|Abobotulinum toxin A|
16096613|NCT02187640|Behavioral|Self-administered acupressure|Self-administered acupressure: In order to ensure the compliance of treatment, they would apply this intervention according to the acupressure group protocol once per day in groups with one trained research nurse's instructions and supervision .
16096614|NCT02187640|Behavioral|Sham control group|Sham intervention: Patients received similar aupressure intervention on the non-acupoints.
16096615|NCT02187627|Drug|[11C]RO6924963|Radiolabeled low molecular weight compound, administered as single intravenous injection. The mass dose of [11C]RO6924963 injected will be </=10 micrograms (mcg), injection volume </=20 milliliters (mL). Target injected activity for [11C]RO6924963 will be 370-740 megabecquerel (MBq) [10-20 millicurie (mCi)].
16096616|NCT02187627|Drug|[11C]RO6931643|Radiolabeled low molecular weight compound, administered as single intravenous injection. The mass dose of [11C]RO6931643 injected will be </=10 mcg, injection volume </=20 mL. Target injected activity for [11C]RO6931643 will be 370-740 MBq (10-20 mCi).
16096617|NCT02187627|Drug|[18F]RO6958948|Radiolabeled low molecular weight compound, administered as single intravenous injection. The mass dose of [18F]RO6958948 injected will be </=10 mcg, injection volume </=20 mL. Target injected activity for [18F]RO6958948 will be 185-370 MBq (5-10 mCi). The final activity of [18F] RO6958948 will be adjusted up to 10 mCi per scan to allow sufficient counts by end of 200 minutes post radiotracer injection.
16096618|NCT02187614|Drug|Diclofenac|
16096619|NCT02187614|Drug|Morphine|
16096620|NCT02187614|Drug|Paracetamol|
16096621|NCT02187614|Drug|Placebos|
16096622|NCT02187601|Device|MPBA System|MPBA is the new generation Multi Purpose Breath Analyzer
16096623|NCT02187601|Device|BreathID|BreathID is the name of the original Exalenz breath analyzer system
16096624|NCT02187588|Drug|Eschscholtzia Californica - low dose|
16096625|NCT02187588|Drug|Eschscholtzia Californica - high dose|
16096626|NCT02187588|Drug|Ibuprofen|
16096627|NCT02187588|Drug|Eschscholtzia Californica - low dose Placebo|
16096628|NCT02187588|Drug|Eschscholtzia Californica - high dose Placebo|
16096629|NCT02187588|Drug|Ibuprofen Placebo|
16096630|NCT02187575|Drug|UHAC 62 XX tablet|
16096631|NCT02187575|Drug|UHAC 62 XX capsule|
16096632|NCT02187562|Drug|Meloxicam|
16096633|NCT02187562|Drug|Aspirin|
16096634|NCT02187549|Device|HYMOVIS|Intra-articular injection
16096635|NCT02187549|Device|Placebo|Intra-Articular Injection
16096636|NCT02187536|Drug|Telmisartan|
16096637|NCT02187536|Drug|Simvastatin|
16096638|NCT02187536|Drug|Telmisartan placebo|
16096639|NCT02187523|Drug|Hydrochlorothiazide|
16096640|NCT02187523|Drug|Telmisartan|
16096641|NCT02187523|Drug|Telmisartan/HCTZ FDC|
16096642|NCT02187510|Procedure|Umbilical cord milking|Once the preterm is born keep the baby from the mother's thighs. The obstetrician cord milking three times (2seconds/milking) taking the cord from the base 20cm respect towards the baby. Then clamp de cord.
16096643|NCT02187510|Procedure|Delayed cord clamping|Once the preterm is born the neonatologist keep the baby beside the mother at level of the operating table during 30 seconds without cord clamping. The baby is covered with a polythene bag and put a cap on his head. Then the obstetritian clamp the cord.
16096644|NCT02187497|Drug|Low dose of BIBR 277|
16096645|NCT02187497|Drug|Medium dose of BIBR 277|
16096646|NCT02187497|Drug|High dose of BIBR 277|
16096647|NCT02187484|Drug|BIBR 277|
16096648|NCT02187471|Drug|DS-5565|DS-5565 15 mg QD or BID; tablet for oral use
16096649|NCT02187471|Drug|Pregabalin|Pregabalin capsule for oral use; 75 mg capsule for one week, then 150 mg capsule
16096650|NCT02187471|Drug|Placebo tablet|Placebo tablet for oral use, matching DS-5565 tablet
16096651|NCT02187471|Drug|Placebo capsule|Placebo capsule for oral use, matching pregabalin capsule
16096652|NCT02187445|Drug|Budesonide inhalation suspension|To determine the acceptability of budesonide inhalation suspension (BIS) 0.5 QD for 6 months for children with SCD that develop ACS between 1 and 4 years of age (n=10).
16096653|NCT02187419|Other|Hypnosis|"Hypnosis is a promising, but under-studied non-pharmacological treatment option for poor sleep during the menopausal transition. Hypnosis is a mind-body therapy that may be defined as a deeply relaxed state involving mental imagery and suggestion. The hypnotic state has been described variously as being an altered state of consciousness, focused attention, imaginative involvement, and role assumption.
~However, it is generally agreed that hypnosis is a state or condition, which occurs when appropriate suggestions elicit distortions of perception, memory, or mood. Research has shown that most people are hypnotizable. Hypnosis intervention for managing chronic symptoms usually involves a hypnotic induction, instruction in self-hypnosis and practice using audio recordings."
16096654|NCT02187406|Procedure|Modified ankle athletic taping|
16096655|NCT02187406|Procedure|Traditional ankle athletic taping|
16096656|NCT02187367|Biological|EGF Vaccine|1.2mL of conjugate-adjuvant mix injection at four sites during the Post First-Line Chemotherapy. Reduced dose of injection at two sites during the Pre-Progression Phase.
16096705|NCT02187055|Drug|Tofacitinib with methotrexate|Tofacitinib 5 mg twice daily, oral for 12 months Methotrexate (previous stable dose 15-25 mg) every week, oral for 12 months Placebo for adalimumab every other week, subcutaneous for 12 months
16096706|NCT02187055|Drug|Tofacitinib without methotrexate|Tofacitinib 5 mg twice daily, oral for 12 months Placebo for methotrexate (previous stable dose) every week, oral for 12 months Placebo for adalimumab every other week, subcutaneous for 12 months
16096657|NCT02187354|Drug|Blinatumomab|A single cycle of blinatumomab (CIVI) treatment is 6wks, 4wks of treatment followed by a 2wk treatment-free interval. Up to 5 cycles will be administered per subject. In the first cycle, for patients with an M3 bone marrow, the initial dose will be 5μg/m2/day for the first 7days, escalated to 15μg/m2/day on D8-D29. For all subsequent cycles 15μg/m2/day will be the dose for all 4wks of continuous treatment. In case of M2 bone marrow or M1 bone marrow with an MRD relapse at screening, the initial dose will start at 15μg/m2/day for the first 7days of treatment & no dose step at D8. For all subsequent cycles the dose will remain 15μg/m2/day. A dose of 9μg/day for the initial dose (if applicable) & 28μg/day for the escalated dose after dose step should not be exceeded.
16096658|NCT02187354|Other|Extension of LTFU as per ProtocolAmendment7 7Jun18|LTFU (Long Term Follow-Up) will extend past 18 months for patients already ended the study/still on study or to be enrolled at European sites if they did not receive a transplantation after blinatumomab treatment. For subjects to be included in the additional LTFU, data will be captured until subjects are 18yrs old (every 6 months by phone contact). The following will be captured: relapse (medullary or extra-medullary relapse and its specific location), second tumor (which type), alive/died and cause of death, hospitalization and reason for hospitalization.
16096659|NCT02187341|Dietary Supplement|5-HTP|Volunteers participate in two visits at least 5 days apart . The day of their visit they ingest (2 hours before reporting to the laboratory) either a capsule containing 200 mg of 5-HTP or a capsule containing placebo (sugar pill). The order of the visits is randomized
16096660|NCT02187341|Dietary Supplement|Placebo|Volunteers participate in two visits at least 5 days apart . The day of their visit they ingest (2 hours before reporting to the laboratory) either a capsule containing 200 mg of 5-HTP or a capsule containing placebo (sugar pill). The order of the visits is randomized
16096661|NCT02187328|Other|Grapefruit juice|Volunteers participate in two visits at least 5 days apart. The day of their visit they ingest 12.5 oz of grapefruit juice in the morning and 12.5 oz of grapefruit juice ingested in the afternoon, 3h before reporting to the laboratory. The order of the visits is randomized, one visit volunteers ingest apple juice only, the other visit grapefruit juice only
16096662|NCT02187328|Other|Apple juice|Volunteers participate in two visits at least 5 days apart. The day of their visit they ingest 12.5 oz of grapefruit juice or Apple juice ingested in the morning and 12.5 oz of grapefruit juice ingested in the afternoon, 3h before reporting to the laboratory. The order of the visits is randomized, one visit volunteers ingest apple juice only, the other visit grapefruit juice only
16096663|NCT02187315|Device|Chrono-chemotherapy pump:Melodie|
16096664|NCT02187315|Device|Routine intravenous drip|
16096665|NCT02187315|Drug|induction chemotherapy|
16096666|NCT02187315|Drug|cisplatin chrono-chemotherapy|
16096667|NCT02187315|Radiation|intensity-modulated radiation therapy|
16096668|NCT02187315|Drug|cisplatin routine-chemotherapy|
16096669|NCT02187302|Drug|CRLX101|
16096670|NCT02187302|Drug|Bevacizumab|
16096671|NCT02187302|Drug|Standard of Care (Investigator Choice)|
16096672|NCT02187289|Device|Night-time compression bandages|Daytime compression sleeve plus night-time compression by self-administered or assisted multi-layered compression bandages.
16096673|NCT02187289|Device|Compression Sleeve, daytime wear|
16096674|NCT02187289|Device|Night-time Compression custom-made garment|Standard Care plus night-time compression by a custom-made night time compression system garment.
16096675|NCT02187276|Drug|cholinesterase inhibitors|The first group received donepezil (5 or 10 mg) the second group received galantamine (16 or 24 mg) The third group received rivastigmine (3 or 4,5 or 6 mg BID) according to the treating physician.
16096676|NCT02187250|Drug|metformin|
16096677|NCT02187250|Drug|liraglutide|
16096678|NCT02187250|Drug|roflumilast|
16096679|NCT02187237|Device|YOLO TOUCH Low Level Laser|
16096680|NCT02187224|Drug|Progesterone|
16096681|NCT02187224|Drug|Placebo (for Progesterone)|
16096682|NCT02187211|Drug|Minocycline|
16096683|NCT02187211|Drug|Placebo (for Minocycline)|
16096684|NCT02187198|Drug|Buprenorphine|
16096685|NCT02187185|Other|Sonicare/Elite-Flexcare Toothbrush|Philips Oral Healthcare product - battery powered menchanic toothbrush with nylon bristles
16096686|NCT02187185|Other|Manual Toothbrush|traditional (non-mechanical) toothbrush with nylon bristles and plastic handle
16096687|NCT02187172|Drug|Ustekinumab|
16096688|NCT02187172|Drug|Placebo|
16096689|NCT02187159|Drug|DS-5565|DS-5565 15 mg tablet for oral administration
16096690|NCT02187159|Drug|Pregabalin|Pregabalin 150 mg capsule for oral administration
16096691|NCT02187159|Drug|Placebo tablet|Placebo tablet (matching DS5565) for oral administration
16096692|NCT02187159|Drug|Placebo capsule|Placebo capsule (matching pregabalin) for oral administration
16096693|NCT02187133|Drug|Carfilzomib|"Given IV; Dose Level (DL)
~Twice Weekly:
~DL -1 and DL 1: 15 mg/m^2
~Weekly:
~DL 1.5: 20,27,27 mg/m^2, DL 2: 20,36,36 mg/m^2, DL 3: 20,56,56 mg/m^2 DL 4: 20,70,70 mg/m^2"
16096694|NCT02187133|Drug|Bendamustine|"Given IV; Dose Level (DL)
~DL -1: 75 mg/m^2 DL 1,1.5, 2, 3, and 4: 90 mg/m^2"
16096695|NCT02187133|Drug|Rituximab|Given IV; 375 mg/m^2
16096696|NCT02187120|Drug|Tranexamic Acid|Tranexamic acid is a synthetic lysine derivative that inhibits fibrinolysis by blocking the lysine binding sites on plasminogen therefore inhibiting the conversion of plasminogen to plasmin. Intravenous injection of 1g Tranexamic Acid will be administered in the pre-hospital setting followed by 1g Tranexamic Acid infused intravenously over 8 hours initiated in the hospital emergency department.
16096697|NCT02187120|Drug|Placebo|
16096698|NCT02187107|Drug|TMC114|300 mg tablets of TMC114 ethanolate with microcrystalline cellulose, colloidal silicon dioxide, crospovidone, magnesium stearate, and Opadry® Orange
16096699|NCT02187107|Drug|rtv|100 mg tablet of Norvir®
16096700|NCT02187094|Drug|TC-6499|
16096701|NCT02187094|Drug|Placebo|
16096702|NCT02187081|Procedure|radiofrequency ablation plus Sorafenib|To treat HCC with the combination of radiofrequency ablation and sorafenib
16096703|NCT02187081|Procedure|Radiofrequency ablation|To treat HCC with radiofrequency ablation alone.
16096704|NCT02187068|Drug|Dexmedetomidine|Dexmedetomidine administered intravenously
16096753|NCT02186756|Other|EMG-Biofeedback and Usual care|Please refer to arm description
16096707|NCT02187055|Biological|Adalimumab with methotrexate|Placebo for tofacitinib twice daily, oral for 12 months Methotrexate (previous stable dose 15-25 mg) every week, oral for 12 months Adalimumab 40 mg every other week, subcutaneous for 12 months
16096708|NCT02187042|Other|Best supportive care|BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life
16096709|NCT02187042|Other|call center|Nurses from a call center will call the patients at regular time to help patients in the management of their cancer, with some dietetic advices, medical advices etc.
16096710|NCT02187029|Drug|PF-06743649|Daily dosing (dose level 1) tablet for 14 days
16096711|NCT02187029|Other|Placebo|Daily dosing (tablet) for 14 days
16096712|NCT02187029|Drug|PF-06743649|Daily dosing (dose level 2) tablet(s) for 14 days
16096713|NCT02187029|Other|Placebo|Daily dosing (tablets) for 14 days
16096714|NCT02187016|Device|AirFloss + BreathRx|Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.
16096715|NCT02187016|Device|AirFloss + Listerine|Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning plus Rinse used once daily.
16096716|NCT02187016|Device|Dental Floss|Manual Toothbrush used twice daily, 1 minute. Interproximal cleaning used once daily.
16096717|NCT02187016|Device|Manual Toothbrush|Manual Toothbrush used twice daily, 1 minute.
16096718|NCT02187003|Drug|Rivipansel|Rivipansel (GMI-1070) will be infused intravenously every 12 hours up to 15 doses maximum. Subjects aged 12 and over who weigh more than 40 kilograms will receive a dose of 1680 mg of rivipansel, followed by a dose of 840 mg of rivipansel every 12 hours. All subjects aged 6 to 11 years and any subject who weighs 40 kilograms or less, will receive weight-based dosing (mg/kg) of 40 mg/kg of rivipansel (maximum of 1680 mg) followed by a dose of 20 mg/kg of rivipansel (maximum of 840 mg) every 12 hours.
16096719|NCT02187003|Other|Placebo|Placebo (phosphate buffered saline) will be infused intravenously every 12 hours up to 15 doses maximum.
16096720|NCT02186990|Drug|propofol|2,5 mg/kg
16096721|NCT02186990|Drug|etomidate|0,3 mg/kg
16096722|NCT02186990|Drug|etomidate-propofol|0,15 mg/kg etomidate + 1,25 mg/kg propofol
16096723|NCT02186977|Device|VAX-ID|0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection
16096724|NCT02186977|Drug|1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD)|1.0 cc HBVAXPRO 10mcgr/ml (Sanofi Pasteur MSD)
16096725|NCT02186977|Drug|0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD)|0.1cc HBVAXPRO 40mcgr/ml (Sanofi Pasteur MSD) with each injection
16096726|NCT02186964|Procedure|tension free primary closure|tension free primary closure of the defects created by excision of the pilonidal sinus
16096727|NCT02186964|Procedure|karydakis|the defect after excision of the pilonidal sinus is closed by Karydakis procedure
16096728|NCT02186964|Procedure|Limberg flap|defect after excision of the pilonidal sinus is closed by Limberg flap procedure
16096729|NCT02186951|Drug|Amoxicillin - clavulanic acid|Amoxicillin-clavulanic acid 1g, three times a day during 2 days, started within one hour after randomization and before the beginning of hypothermia.
16096730|NCT02186951|Drug|Placebo|Placebo 1g, three times a day during 2 days, started within one hour after randomization and before the beginning of hypothermia.
16096731|NCT02186938|Device|FloTrac|
16096732|NCT02186912|Device|Nobel Active, Nobel Procera IBO|
16096733|NCT02186899|Other|Ultrasound Guided Femoral Sciatic Obturator nerve blocks|
16096734|NCT02186899|Other|General Anesthesia femoral bolus|
16096735|NCT02186899|Other|General anesthesia femoral continuous|
16096736|NCT02186886|Drug|Golimumab|Physiological Intermolecular Modification Spectroscopy
16096737|NCT02186873|Drug|Placebo|Participants will receive matching placebo.
16096738|NCT02186873|Drug|Golimumab|Participants will receive 2mg/kg of intravenous infusions of golimumab .
16096739|NCT02186860|Biological|CAR-T cells|Given IV
16096740|NCT02186847|Radiation|Radiation Therapy|Radiation therapy (RT) is given in 2 Gy fractions once daily 5 days per week to a total of 30 fractions and 60 Gy. Photons required; 3-dimensional conformal radiation therapy (3D-CRT) or intensity-modulated radiation therapy (IMRT) permitted. Starts within 14 days of randomization (Chemoradiation arm) or 14 days after metformin starts (Chemoradiation + Metformin arm).
16096741|NCT02186847|Drug|Carboplatin|2 AUC (area under the curve) via IV weekly on days 1, 8, 15, 22, 29, and 36 from start of radiation therapy. Two 21 day cycles of 6 AUC via IV starting 28-42 days after the end of radiation therapy.
16096742|NCT02186847|Drug|Metformin|Metformin is taken orally. Dose escalation begins 2 weeks prior to the initiation of chemoradiation. 500 mg twice daily days 1-7 of metformin. 500 mg three times daily days 8-14 of metformin. Three times a day with the following dosage: 500mg in the morning, 1000mg at noon, and 500mg in the evening concurrent with chemoradiation and through consolidation chemotherapy (days 15-126 of metformin),
16096743|NCT02186847|Drug|Paclitaxel|50 mg/m2 via IV weekly on days 1, 8, 15, 22, 29, and 36 from start of radiation therapy. Two 21 day cycles of 200 mg/m2 via IV 28-42 days after the end of radiation therapy.
16096744|NCT02186834|Drug|Selinexor|Selinexor orally as outlined in the study treatment arm.
16096745|NCT02186834|Drug|Liposomal doxorubicin|Pegylated liposomal doxorubicin at a starting dose of 20 mb/m² as outlined in the treatment arm.
16096746|NCT02186834|Drug|Dexamethasone|Participants will be instructed to take Dexamethasone 40 mg (10 tablets) orally once weekly with meals (ideally with breakfast to minimize insomnia). Participants older than 75 years and patients previously intolerant to 40 mg dosage will be allowed to receive 20 mg (5 tablets) once a week.
16096747|NCT02186821|Drug|Ceritinib|Ceritinib was dosed on a flat scale of 750 mg (e.g., 5 x 150 mg capsules) orally,once daily, on a continuous dosing cycle. A complete treatment cycle was defined as 28 days. There were no breaks between dosing cycles.
16096748|NCT02186808|Device|Procera® Bridge Zirconia|Patients planned for treatment with a tooth-supported 3 to 4-unit bridge in any position of the maxilla or the mandible.
16096749|NCT02186782|Drug|Clomiphene citrate and Estradiol|Women will receive clomiphene citrate (100 mg/day for 5 consecutive days from day 2 of cycle) and estradiol (2 mg/day for 5 consecutive days from day 2 of cycle)
16096750|NCT02186782|Drug|Clomiphene citrate and Placebo|Women will receive clomiphene citrate (100 mg/day for 5 consecutive days from day 2 of cycle) and placebo (for 5 consecutive days from day 2 of cycle)
16096751|NCT02186769|Drug|Risperdal® Consta®|
16096752|NCT02186769|Drug|LY03004|
16096754|NCT02186743|Other|Personalized Dietary Advice|Personalized dietary advice based on a commercially available blood test. Participants will be instructed to avoid eating selected foods for the duration of the intervention period (4 weeks). Some foods will be acceptable to consume every four days in rotation diet fashion.
16096755|NCT02186730|Behavioral|Stressbusters|cCBT
16096756|NCT02186730|Behavioral|Websites|Self help websites
16096757|NCT02186717|Dietary Supplement|Chewing gum|Patients will be asked to chew gum three times a day for 30 minutes each time
16096758|NCT02186704|Device|ICD with DX system|Implantable cardioverter defibrillator (ICD) system implantation with single lead with ventricular sensing and pacing and defibrillation combined with dedicated atrial sensing dipole.
16096759|NCT02186691|Other|MRI|
16096760|NCT02186678|Other|PET-CT|
16096761|NCT02186665|Drug|calcitriol ointment|
16096762|NCT02186665|Drug|placebo comparator|
16096763|NCT02186652|Drug|Pantoprazole|
16096764|NCT02186626|Biological|WN/DEN4Δ30 Vaccine|WN/DEN4Δ30 vaccine is a live attenuated, recombinant, chimeric virus. Dose: 10^4 plaque-forming units (PFUs); delivered by subcutaneous injection in the deltoid region of the upper arm.
16096765|NCT02186626|Biological|Placebo|Delivered by subcutaneous injection in the deltoid region of the upper arm.
16096766|NCT02186613|Behavioral|Telephone support|Telephone support intervention to improve breastfeeding rates. The intervention will consist in weekly calls during the first two months and every two weeks between the second and the sixth month. The intervention will be done by pediatric nurses and we have developed a protocol of important issues to deal depending on the age of the baby.
16096767|NCT02186600|Drug|Calcium Carbonate|Used as daily supplement to ensure subject obtains 1200 mg of calcium per day (diet + supplement)
16096768|NCT02186600|Drug|Vitamin D3|Subjects will receive Vitamin D3 supplements to ensure serum level of Vitamin D is at least 30 ng/ml.
16096769|NCT02186600|Drug|Risedronate|Risedronate 35 mg orally will be ingested weekly by subjects in Risedronate group.
16096770|NCT02186600|Behavioral|Bone-loading exercises|Subjects will participate in bone loading exercises (weight-bearing and resistance) three times weekly at community YMCAs.
16096771|NCT02186587|Device|ConforMIS custom total knee|Total knee arthroplasty using ConforMIS custom total knee system with follow-up at 6 months
16096772|NCT02186574|Drug|Tenofovir disoproxil|
16096773|NCT02186574|Drug|Placebo Oral Tablet|
16096774|NCT02186561|Device|Pipeline™ Embolization Device/ Pipeline™Flex Embolization Device|
16096775|NCT02186548|Procedure|Closed surgical technique|"Surgically uncovering of the impacted canine with a mucoperiosteal flap dissected off the bone
~The bone covering the canine is being removed
~Attachment with a chain is bonded to the exposed tooth
~The palatal flap is repositioned and sutured back with the chain above the mucosa. Shortly after the surgery
~The canine is orthodontically moved beneath the palatal mucosa"
16096776|NCT02186548|Procedure|Open surgical technique|"Surgically uncovering of the impacted canine, removing a window of tissue from around the tooth
~Pack/filling material is applied on the tooth
~Spontaneous eruption of the palatally impacted canine is allowed expected
~The canine is orthodontically moved above the mucosa"
16096777|NCT02186535|Dietary Supplement|Vitamin D and Calcium|
16096778|NCT02186509|Radiation|Hyperfractionated radiation therapy|Undergo hyperfractionated radiation therapy
16096779|NCT02186509|Radiation|Stereotactic radiosurgery|Undergo stereotactic radiosurgery
16096780|NCT02186509|Drug|Alisertib|Given PO
16096781|NCT02186509|Procedure|Quality-of-life assessment|Ancillary studies
16096782|NCT02186496|Drug|CKD-330 8/5mg|
16096783|NCT02186496|Drug|Candesartan 8mg and Amlodipine 5mg|
16096784|NCT02186483|Drug|Metformin|Metformin,1000mg, once daily
16096785|NCT02186483|Drug|Rosuvastatin|Rosuvastatin, 20 mg, once daily
16096786|NCT02186483|Drug|Metformin and Rosuvastatin|Metformin, 1000mg, once daily Rosuvastatin, 20mg, once daily
16096787|NCT02186470|Radiation|accelerated partial breast irradiation|Undergo image-guided intensity-modulated APBI
16096788|NCT02186470|Radiation|intensity-modulated radiation therapy|Undergo image-guided intensity-modulated APBI
16096789|NCT02186470|Radiation|image-guided radiation therapy|Undergo image-guided intensity-modulated APBI
16096790|NCT02186470|Procedure|therapeutic conventional surgery|Lumpectomy
16096791|NCT02186457|Drug|Polymyxin B in Normal Saline|Antibiotic irrigation via peritoneal lavage
16096792|NCT02186457|Other|Placebo: Normal Saline|Placebo irrigation via peritoneal lavage
16096793|NCT02186444|Other|Personalized Health Information Navigator (PHIN)|"The application (or app) titled Personalized Health Information Navigator (PHIN) is an interactive psycho-educational intervention that will be delivered via mobile tablet technology. The PHIN provides patient-centered education. At the first meeting, the community navigator will provide a visual demonstration of PHIN on the Apple iPad. The community navigator will leave the iPad with the participant for 6-weeks and will stress the importance of using the PHIN app to address any educational or psychosocial needs."
16096794|NCT02186444|Other|NCI Information Booklets (IB)|"Participants will receive a packet of information booklets (What You Need to Know About Prostate Cancer; Taking Time: Support for People with Cancer; and Facing Forward, Life After Cancer Treatment) that address prostate cancer treatment options, the late and long term effects, follow-up care, and sources of support. At the first meeting, the community navigator will provide a review of the print materials and stress the importance of reading the booklets carefully to help prepare for the discussion with your healthcare provider. The community navigator will leave the print materials with the participant for 6-weeks."
16096795|NCT02186431|Device|senofilcon A|
16096796|NCT02186418|Genetic|ARU-1801|"Autologous CD34+ hematopoietic stem cells transduced ex-vivo with a gamma-globin lentiviral vector
~Subjects with sickle cell anemia will undergo hematopoietic stem cell procurement by bone marrow harvest or apheresis after mobilization with plerixafor
~Reduced intensity chemotherapy conditioning with single dose melphalan will be used to facilitate engraftment of ex-vivo transduced cells."
16096797|NCT02186405|Drug|LEVOTHYROXINE|administration of levothyroxine
16096798|NCT02186392|Device|Circadian Light luminaries|The light is programmed to have the desired light intensity (lux), color temperature (Kelvin) and wavelength (nm) according to the knowledge about the phase-response curve.
16096837|NCT02186028|Drug|Vitamin D|Vit D 400 IU vs. Vit D 200 IU
16096799|NCT02186379|Behavioral|RePace Intervention|The Re-Pace intervention will provide children and parents/caregivers training in strategies to promote slower eating pace and greater awareness of satiety levels. These skill building strategies can be classified as follows: 1) learning to slow eating rate, 2) awareness-raising activities; 3) role play activities; 4) self-monitoring training; 5) goal setting challenges; and 6) parent training. A core strategy for achieving slower eating pace and improved satiety will be to increase fruit and vegetable intake to meet United States Department of Agriculture (USDA) guidelines (www.myplate.gov). There are 5 intervention visits lasting about 1 to 1.25 hours each. See Section 4.3.1 for more details of the Re-Pace intervention.
16096800|NCT02186379|Behavioral|Usual Care Control|"Following the second test meal session, parents and children will receive a brief (25 minute) instruction on healthy eating using materials from www.ChooseMyPlate.gov site, including What's on Your Plate and My Plate for Kids mini-posters."
16096801|NCT02186366|Other|Abdominal Massage Therapy|Abdominal Massage Therapy , 30 minutes, three times one week for 6 weeks. If the subjects have recovered in the treatment of 6 weeks, we can end treatment early.
16096802|NCT02186366|Drug|Buspirone|Buspirone by mouth 5mg three times per day for 6week. If the subjects have recovered in the treatment of 6 weeks, we can end treatment early.
16096803|NCT02186353|Behavioral|Partial feeding study|Provision of all grain foods where only the processing of kernels used to produce the grain foods will differ among test diets. Each participant will be assigned to complete the three 4-week test diets in random sequence.
16096804|NCT02186340|Procedure|Inspiratory muscle training|
16096805|NCT02186327|Behavioral|Integrative Health Coaching|Coaching sessions will guide subjects in establishing and maintaining behavior change goals related to their health and overall well-being.
16096806|NCT02186314|Device|Pacemaker Biotronik: apical stimulation|Patients with pacemaker (Biotronik): an electrode will be implanted in the apical position of the right ventricle and an electrode implanted in the septal position of the right ventricle.The patients will remained in apical stimulation for two months, after that they will be subjected to evaluation. At the end of the evaluation, patients will undergo cross-over groups( bifocal stimulation) and patients will be kept in the new pacing mode for two months when they will be submitted to clinical, laboratory evaluation and assessment of pacemaker
16096807|NCT02186314|Device|Pacemaker Biotronik: bifocal stimulation|Patients with pacemaker (Biotronik): an electrode will be implanted in the apical position of the right ventricle and an electrode implanted in the septal position of the right ventricle.The patients will remained in bifocal stimulation for two months, after that they will be subjected to evaluation. At the end of the evaluation, patients will undergo cross-over groups( apical stimulation) and patients will be kept in the new pacing mode for two months, when they will be submitted to clinical, laboratory evaluation and assessment of pacemaker
16096808|NCT02186301|Drug|Rociletinib Mono-Therapy|Rociletinib will be administered twice daily
16096809|NCT02186301|Drug|Erlotinib Mono-Therapy|Erlotinib will be administered once a day
16096810|NCT02186288|Other|High-flow nasal cannula oxygen|
16096811|NCT02186275|Drug|Vitamin D3: 3000 or 4000 UI/day then 2,000 UI/day|"Weight at inclusion < 40 kg : 3 capsules of 1000 UI per day at induction and 2 capsules of 1000 UI per day at maintenance.
~Weight at inclusion ≥ 40 kg : 4 capsules of 1000 UI per day at induction and 2 capsules of 1000 UI per day at maintenance."
16096812|NCT02186275|Drug|Vitamin D3 800 UI/day then 800 UI/day|"Weight < 40 kg: 2 capsules of 400 UI per day and 1 capsules of placebo at induction and 2 capsules of 400 UI per day at maintenance
~Weight ≥ 40 kg: 2 capsules of 400 UI per day and 2 capsules of placebo at induction and 2 capsules of 400 UI per day at maintenance"
16096813|NCT02186249|Drug|Nivolumab|
16096814|NCT02186249|Drug|Ipilimumab|
16096815|NCT02186223|Device|The Angel® Catheter|The Angel® Catheter is a temporary device that combines the functions of an inferior vena cava (IVC) filter and a 3-lumen central venous catheter (CVC). The device can be placed at the bedside into the inferior vena cava via the femoral vein for the prevention of Pulmonary Embolism (PE) and for access to the central venous system. The device is intended for short-term (less than 30 days) vascular access via the femoral vein.
16096816|NCT02186210|Device|prewarming|recovery slope StO2
16096817|NCT02186197|Other|Critical Care Ultrasound|A critical care ultrasound exam will be performed on all patients included in this study
16096818|NCT02186184|Device|Orthokeratology|
16096819|NCT02186184|Device|Spectacle|
16096820|NCT02186171|Biological|Romosozumab|Administered by subcutaneous injection once a month.
16096821|NCT02186171|Drug|Placebo|Administered by subcutaneous injection once a month.
16096822|NCT02186158|Drug|Vitamin C|
16096823|NCT02186158|Drug|Placebo|
16096824|NCT02186145|Drug|Association of metronidazole; nystatin and dexamethasone|
16096825|NCT02186145|Drug|Flagyl|Vaginal cream of metronidazole and nystatin
16096826|NCT02186132|Drug|Atropine 0.6 mg|Atropine 0.6 mg intravenous
16096827|NCT02186132|Drug|Atropine 1.2 mg|Atropine 1.2 mg intravenous
16096828|NCT02186119|Drug|abicipar pegol|Abicipar pegol administered to the study eye by intravitreal injection at the visits noted per protocol.
16096829|NCT02186119|Drug|ranibizumab|Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24.
16096830|NCT02186119|Other|sham procedure|Sham procedure to the study eye at the visits noted per protocol.
16096831|NCT02186106|Drug|Cholecalciferol|
16096832|NCT02186080|Drug|Gemigliptin|
16096833|NCT02186080|Drug|Placebo|
16096834|NCT02186067|Other|Referral System|"Primary Level:
~Refer patients to secondary care centre if Patients has complicated hypertension (Patients with target organ damage, CVD, CKD or more the 3 drugs)
~Secondary Level:
~Community health center at Aga Khan University will serve as the secondary care center.
~Family physician will manage patients with CVD, CKD or more than 3 drugs.
~Tertiary care:
~Cardiologist at the Aga Khan University will manage secondary, resistant and difficult to treat hypertension.
~Behavioral: Other Interventions CME session by Cardiologist/Consultant Family Physician : At start , and at two months Community screening by Family physicians at the primary care center (open house) once in three months Patient group education session. Once in three months"
16096835|NCT02186054|Device|MRI examinations|Consented patients will be required to stay in the MRI scanner to complete the 2 additional sequences once their standard exam is completed.
16096836|NCT02186041|Device|Sacral Nerve Modulation|
16096838|NCT02186015|Drug|Cholecalciferol|Enrolled women will receive 50,000 IU weekly supplementation of cholecalciferol for 8 weeks.
16096839|NCT02186002|Drug|ACT-451840 10 mg|ACT-451840 was provided as dry powder, which was reconstituted as a suspension with 25 mL of tap water
16096840|NCT02186002|Drug|ACT-451840 50 mg|ACT-451840 was provided as dry powder, which was reconstituted as a suspension with 25 mL of tap water
16096841|NCT02186002|Drug|ACT-451840 200 mg|ACT-451840 was provided as dry powder, which was reconstituted as a suspension with 25 mL of tap water
16096842|NCT02186002|Drug|ACT-451840 500 mg|ACT-451840 was provided as dry powder, which was reconstituted as a suspension with 25 mL of tap water
16096843|NCT02186002|Drug|ACT-451840 1000 mg|ACT-451840 was provided as dry powder, which was reconstituted as a suspension with 25 mL of tap water
16096844|NCT02186002|Drug|ACT-451840 (Dose to be determined)|ACT-451840 was provided as dry powder, which was reconstituted as a suspension with 25 mL of tap water
16096845|NCT02186002|Drug|Placebo|
16096846|NCT02185989|Other|Early electrical stimulation and early leg bicycling added to early standard rehabilitation|
16096847|NCT02185976|Other|cartoon|5 different cartoons which will be recorded on a tablet PC.
16096848|NCT02185963|Drug|Rosuvastatin|Rosuvastatin 20mg once a daily for 12 weeks
16096849|NCT02185950|Device|ultrasound|
16096850|NCT02185950|Device|paraffin|
16096851|NCT02185950|Device|endermotherapy|
16096852|NCT02185937|Dietary Supplement|cola|imatinib intake with coca-cola
16096853|NCT02185924|Drug|Parecoxib|
16096854|NCT02185924|Drug|CONTINUOUS FEMORAL BLOCK WITH ROPIVACAINE 0,2%|
16096855|NCT02185924|Drug|N/S 0.9%|
16096856|NCT02185898|Other|Leading U.S. non-menthol cigarette|Tobacco-burning non-menthol cigarette
16096857|NCT02185898|Other|Leading U.S. menthol cigarette|Tobacco-burning menthol cigarette
16096858|NCT02185898|Other|Electronic cigarette #1|Electronic cigarette
16096859|NCT02185898|Other|Electronic cigarette #2|Electronic cigarette
16096860|NCT02185898|Other|Electronic cigarette #3|Electronic cigarette
16096861|NCT02185898|Other|U.S. Market-sample electronic cigarettes|Marketed electronic cigarettes
16096862|NCT02185885|Procedure|Increased bloodpressure during CPB.|
16096863|NCT02185872|Other|High-Intensity Functional Training|Participants were instructed to work as hard as they could while maintaining safe technique and proper form to achieve as many reps or rounds as possible in the prescribed time frame. As HIFT participants became accustomed to specific movements, less time was dedicated to practicing movements and technique.
16096864|NCT02185872|Other|Aerobic and Resistance Training|The protocol was based upon current guidelines of 150 minutes moderate-intensity aerobic activity and 2 days of muscle strengthening per week.
16096865|NCT02185859|Drug|Lidocaine|The lidocaine group (Group L)- 1% lidocaine 40 mL is prepared in a 50 mL syringe; A bolus dose of the studied drugs are administered for 15 minutes immediately after a subject is brought into the operating room, and the vital signs are checked (from the beginning of anesthesia induction). Subsequently, an intravenous injection of the maintenance dose is continuously performed and later stopped just before transferring the subject to a recovery room. (Group L subjects are administered lidocaine 2 mg/kg for 15 minutes immediately after the anesthesia induction, and then lidocaine 2 mg/kg/h is continuously injected. The dose of lidocaine and magnesium in this study has been shown in previous studies to be safe and to have an analgesic effect.)
16096866|NCT02185859|Drug|Magnesium Sulfate|the magnesium group (Group M)- MgSO4 4g 40 mL is prepared in a 50 mL syringe.) A bolus dose of the studied drugs are administered for 15 minutes immediately after a subject is brought into the operating room, and the vital signs are checked (from the beginning of anesthesia induction). Subsequently, an intravenous injection of the maintenance dose is continuously performed and later stopped just before transferring the subject to a recovery room. The dose of magnesium in this study has been shown in previous studies to be safe and to have an analgesic effect.
16096867|NCT02185859|Drug|Saline|the control group (Group C) - 0.9% normal saline 40 mL is prepared in a 50 cc syringe. A bolus dose of the studied drugs are administered for 15 minutes immediately after a subject is brought into the operating room, and the vital signs are checked (from the beginning of anesthesia induction). Subsequently, an intravenous injection of the maintenance dose is continuously performed and later stopped just before transferring the subject to a recovery room.Group C subjects are administered the same dose of normal saline.
16096868|NCT02185846|Drug|DYNABAC 250 MG ENTERIC COATED TABLET|
16096869|NCT02185846|Drug|DIRITHROMYCIN 500 MG ENTERIC COATED TABLET|
16096870|NCT02185833|Drug|DIRITHROMYCIN 500 MG ENTERIC COATED TABLET|
16096871|NCT02185833|Drug|DYNABAC 250 MG ENTERIC COATED TABLET|
16096872|NCT02185820|Drug|Carfilzomib|
16096873|NCT02185820|Drug|Pomalidomide|
16096874|NCT02185820|Drug|Dexamethasone|
16096875|NCT02185807|Procedure|video-assisted group|The video assistance patients watch a video in Cantonese or Mandarin explaining the surgery procedure and its risks, benefits and alternatives before discussion with their physicians.
16096876|NCT02185807|Procedure|control group|The control patients receive verbal information and discussion from their physicians.
16096877|NCT02185794|Drug|Voxilaprevir|Voxilaprevir tablets administered orally once daily
16096878|NCT02185794|Drug|Placebo to match voxilaprevir|Placebo to match voxilaprevir tablets administered orally once daily
16096879|NCT02185794|Drug|SOF/VEL|400 mg/100 mg FDC tablet administered orally once daily
16096880|NCT02185781|Other|Autologous NK cells infusions|"Each patient will receive repeated intravenous (IV) infusions of escalating doses of expanded autologous NK cells.
~The initial dose will be 1 x 106/kg of recipient body weight (BW), followed by half log increments of the dose level for each infusion, to a maximum of 1 x 108/kg of recipient BW or until they experience any toxicity, for a maximum of 5 infusions. The minimum interval between each infusion will be 28 days. No conditioning therapies will be administered before the infusion of the expanded NK cells. Patients may receive TKI maintenance."
16096881|NCT02185768|Drug|idarubicin|
16096882|NCT02185768|Device|Dc- Beads 300-500µm|
16096883|NCT02185755|Other|Internet-Based Glucose Monitoring System|
16096884|NCT02185755|Drug|Normal Medication Positive Control|
16096885|NCT02185742|Behavioral|Strength Based Case Management|
16096886|NCT02185729|Drug|Intralipid|Infusion of Intralipid (soybean-derived fat)
16096892|NCT02185703|Device|Chordate System S020 in treatment mode|
16096893|NCT02185703|Device|Chordate System S020 in placebo mode|
16096894|NCT02185690|Drug|Binimetinib|"Continuous MEK162 with dose escalation until the Recommended Phase 2 dose (RP2D) one dose level below the Maximum administered dose (MAD) or progression of disease.
~MEK162 tablets 15 mg strength will be taken orally on a BID dose schedule."
16096895|NCT02185690|Drug|Pemetrexed|4-6 cycles given intravenously in combination with carboplatin as per standard therapy.
16096896|NCT02185690|Drug|Carboplatin|4-6 cycles of intravenous Carboplatin in combination with Pemetrexed as per standard therapy.
16096897|NCT02185677|Other|Clinical evaluation|
16096898|NCT02185677|Other|neuropsychological battery test|
16096899|NCT02185677|Other|MRI|
16096900|NCT02185677|Other|Actigraphy|Actigraphy recording will be performed during 7 days after inclusion.
16096901|NCT02185664|Procedure|landmark technique|The apex of the imaginary triangle formed between the two heads of sternocleidomastoid and clavicle was used as the point of needle entry, just lateral to the pulsation of the internal carotid artery and directed towards the ipsilateral nipple at an angle of 45 degrees.
16096902|NCT02185664|Device|Static Ultrasound technique|Static ultrasound guided internal jugular vein cannulation was performed by using the transthoracic echocardiography probe supplied with the transesophageal echocardiography machine in the cardiothoracic surgery operation theatre. The internal jugular vein was located and marked using this method prior to puncture.
16096903|NCT02185651|Drug|Zavesca® Prescription|"Following baseline evaluation, Zavesca® prescription is given.
~Week 2, 4, and 6 ERT infusion with pre-medication are completed at local/home infusion center. Travel to site for week 7 study visit includes physical exam, blood collection and punch muscle biopsy. Health survey is completed."
16096904|NCT02185638|Other|Appetite suppressant properties of YGD and A20-50|3-arm crossover study for investigation of the effect of herbal supplements A20-50 compared to YGD blend and placebo on subjective appetite sensations, glucose, insulin, ghrelin, GLP-1, CCK and ad libitum energy intake
16096905|NCT02185625|Device|Safe Delivery smartphone application|The intervention is the use of a smartphone application called Safe Delivery, designed by University of Copenhagen, Denmark and Maternity Foundation Denmark. The application contains animated videos aimed to train midwives in the prevention and management of postpartum hemorrhage and the treatment of neonatal resuscitation. The instructions in the videos are based on WHO recommendations, and the application is designed to be an on-going tool for midwives, so that they can drill themselves in the emergencies of postpartum hemorrhage and neonatal resuscitation.
16096906|NCT02185612|Behavioral|Savings program|The intervention is a web-based centralized savings account, which is a secure online account without fees. The account offers eligible savers nominal financial rewards for each deposit they make, as a financial incentive for savings.
16096907|NCT02185599|Device|DySIS|Colposcopy performed with the DySIS digital colposcope
16096908|NCT02185586|Procedure|laparoscopic cholecystectomy|
16096909|NCT02185573|Procedure|Bulk fill|This is one of the composite restoration application techniques
16096910|NCT02185573|Procedure|SonicFill|This is the recent intervention under evaluation
16096911|NCT02185560|Drug|Sorafenib (Nexavar, BAY43-9006)|Patients treated by Physician with Nexavar under approved local prescriptions
16096912|NCT02185547|Drug|Zoloft|Sertraline treatment 25 mg
16096913|NCT02185547|Behavioral|ICBT|Internet behavioral cognitive therapy only
16096914|NCT02185534|Drug|Clopidogrel|European clopidogrel tablets, 75 mg (test) versus Japanese clopidogrel tablets, 75 mg (reference); European clopidogrel tablets, 75 mg (test) versus US clopidogrel tablets, 75 mg (reference)
16096915|NCT02185521|Other|patient assessment|Patient clinician status assessment based on Hemodynamic Instability Indicator (HII) trend. The HII indicator combines existing data such as physiologic parameters (Heart Rate, HR; Blood Pressure, BP), laboratory measurements (Albumin; Hematocrit, HCT; Bicarbonate; White Blood Cell, WBC; Blood Urea Nitrogen, BUN), and ADT information (age). HII will be displayed on charting workstation (Workstation on Wheels, WOW). Nurse's role will be to observe the value of HII while accessing WOW desktop (during regular charting), interpret HII value, and share this information to the physician when indicative of potential patient hemodynamic instability to trigger patient clinical status assessment. This intervention is associated with Experimental Study Arm: visible HII.
16096916|NCT02185495|Behavioral|Observer nodule detection|Radiologists will detect the nodules.
16096917|NCT02185495|Device|Computer-aided nodule detection|Computed-aided detection (CAD) software will be used to detect the nodules.
16096918|NCT02185482|Behavioral|Physician Supported Care|
16096919|NCT02185482|Other|Usual care|
16096920|NCT02185469|Procedure|Pneumatic retinopexy|First, a 5/8-in 25-gauge needle will be used to perform an anterior chamber paracentesis, aiming to withdraw a minimum of 0.3 ml of aqueous fluid form the anterior chamber. Then, sulfur hexafluoride (SF6) will be injected in the vitreous cavity. The total volume of gas injected will exceed by 0.3 ml the amount of fluid withdrawn by the anterior chamber paracentesis (ex: 0.6 ml of SF6 would be injected after having withdrawn 0.3 ml). The laser retinopexy will be performed 48 hours later with laser.
16096921|NCT02185469|Procedure|vitrectomy|Under certain circumstances, pneumatic retinopexy can't be considered as a primary treatment for rhegmatogenous retinal detachment. In these cases, the patient will be booked for urgent 25 G vitrectomy with intraoperative laser retinopexy and gas injection to treat retinal detachment
16096922|NCT02185469|Drug|sulfur hexafluoride (SF6)|
16096923|NCT02185469|Device|5/8-in 25-gauge needle|
16096924|NCT02185469|Device|laser|intraoperative laser retinopexy
16096925|NCT02185456|Drug|750 mg metronidazole/ 200 mg miconazole vaginal suppository|The higher dose 750 mg metronidazole/ 200 mg miconazole vaginal suppository will be given to patients who were refractory to the standard of care therapy, oral metronidazole 500 mg twice a day for 7 days, and to asymptomatic patients in a randomized arm, who show poor responses based on the qPCR test result.
16096926|NCT02185456|Drug|Standard of care|oral metronidazole 500 mg twice a day for 7 days
16096927|NCT02185443|Radiation|SBRT|"60Gy in 3 fractions (20Gy/fraction) over 14 days
~60Gy in 5 fractions (12Gy/fraction) over 18 days if organ at risk constraints cannot be met with fractionation above"
16096928|NCT02185430|Drug|saline infusion|saline infusion, bolus of 1.0 μg kg-1 over 10 min followed by a continuous infusion at 0.5 μg kg-1 h-1 infusion during one-lung ventilation, intravenous
16096929|NCT02185430|Drug|dexmedetomidine infusion|dexmedetomidine, bolus of 1.0 μg kg-1 over 10 min followed by a continuous infusion at 0.5 μg kg-1 h-1 infusion during one-lung ventilation, intravenous
16096930|NCT02185417|Drug|Hydrochlorothiazide (HCTZ)|Thiazide-type diuretic. Daily dose of 50 or 25 mg for duration of the study.
16096931|NCT02185417|Drug|Chlorthalidone|Thiazide-type diuretic. Daily dose of 25 or 12.5 mg for duration of the study.
16096932|NCT02185404|Device|wearing the iStride device|The device mimics the actions of the split-belt treadmill, but can be used during over-ground walking and in one's own home, thus enabling long-term training. This device does not require any external power and is completely passive; all necessary forces are redirected from the natural forces present during walking since it utilizes the wearer's weight to generate its movements. This research aims to test the iStride on individuals with stroke in their own home in order to determine if the related effects that we saw in the clinic, can also benefit patients at home.
16096933|NCT02185391|Procedure|Audience Response System|patients use during oral presentations an audience response system
16096934|NCT02185391|Behavioral|Telephone interview|patients receive motivational telephone interviews after their residence in rehabilitation clinics
16096935|NCT02185378|Procedure|I:E ratio 1:2|We plan to evaluate the improvement on respiratory function with different ventilation I:E ratios (1:2 vs. 1:1) during the one-lung ventilation in an obese patients.
16096936|NCT02185378|Procedure|I:E ratio 1:1|The purpose of our study is to compare the effects of minimal prolonged 1:1 IE ratioventilation on respiratory mechanics and oxygenation with conventional 1:2 IE ratio ventilation during OLV in obese patients.
16096937|NCT02185365|Radiation|Magnetic Resonance Imaging (MRI)|Patients will undergo 2 different MRIs of the affected hip. Both MRIs assess hip cartilage degeneration. A contrast agent, Gadolinium, will be used to visualize cartilage during the MRI. The contrast agent is injected through an intravenous (a small plastic tube inserted into a vein in the patients' arm) before the MRI.
16096938|NCT02185352|Drug|BEEP regimen|Bevacizumab 15mg/kg IVF on D1, Etoposide 70 mg/m2 IVF QD, D2-4, Cisplatin 70 mg/m2 IVF on D2, repeat every 3 weeks, for 3 cycles
16096939|NCT02185339|Drug|Rocuronium|Intravenous infusion rate of rocuronium will be titrated to keep post-tetanic count between 1 to 2.
16096940|NCT02185339|Drug|Rocuronium|Intravenous infusion rate of rocuronium will be titrated to keep train-of-four count between 1 to 2.
16096941|NCT02185326|Drug|Growth hormone (Norditropin, Novo nordisk)|Growth hormone (Norditropin, Novo nordisk) was administrated on day 6 of HMG stimulation daily in a dose of 2.5 mg S.C. till the day of hCG administration.
16096942|NCT02185313|Other|visual stimulus to follow|
16096943|NCT02185300|Drug|Dolutegravir Pediatric Granules|Dolutegravir pediatric granules are supplied as 40 grams bulk bottles containing 0.4% weight by weight of dolutegravir to be reconstituted with 73 mL of purified water to yield a dolutegravir concentration of 1.6 milligram / millilitre. 12.5 mL of reconstituted granules contain 20 mg DTG
16096944|NCT02185300|Drug|Dolutegravir Dispersible Tablet|Dolutegravir is available as 5mg dispersible tablets and can be administered as 4 tablets dispersed in 12.5 mL LMC water and consumed immediately or 4 tablets dispersed in 12.5 mL CONTREX mineral water and consumed immediately or 4 tablets dispersed in 12.5 mL LMC water, allow to stand at room temperature for 30 mins, re-suspend mixture and consumed or 4 tablets dispersed in 12.5 mL CONTREX mineral water, allow to stand at room temperature for 30 mins, re-suspend mixture and consumed
16096945|NCT02185261|Drug|Interferon Alfa-2b|Patients who were deemed MRD-positive after day 60 post-transplantation receive interferon α-2b (subcutaneously at dosages of 3 million units 2-3 times per week) . Interferon treatment continues for 6 months in the absence of disease progression or unacceptable toxicity.
16096946|NCT02185248|Behavioral|Wellness Action Plan|The plan included a color-coded BMI chart to help parents understand their child's weight category as well as a brief action planning worksheet to help families create personalized plans around healthy diet and activity changes.
16096947|NCT02185235|Device|Electrical Stimulation|"The Chartered Society of Physiotherapy recommends the following standard for electrical devices.
~Frequency: 35 Hertz. Pulse width: 250µs (0.25ms). Current type: bi-phasic rectangular. Intensity: maximum tolerated. Duty-cycle: 5 seconds on/10 seconds off. Very weak muscles: 5 seconds on/15 seconds off.
~Treatment time: 5 minutes initially, gradually increasing to 20 minutes."
16096948|NCT02185235|Device|Biofeedback|Biofeedback is a treatment technique in which people are trained to improve their health by using signals from their own bodies
16096949|NCT02185235|Other|Pelvic Floor Training|"First, as you are sitting or lying down, try to contract the muscles you would use to stop urinating To contract the pelvic muscles, squeeze for 3 seconds and then relax for 3 seconds.
~Repeat this exercise to 20 minutes each session."
16096950|NCT02185222|Drug|Cholecalciferol 100 000 UI|Study of superiority between Cholecalciferol high dose 100 000 UI versus placebo : one bulb per month during two years
16096951|NCT02185222|Drug|Placebo|Study of superiority between Cholecalciferol high dose 100 000 UI versus placebo : one bulb per month during two years
16096952|NCT02185209|Drug|Placebo|Place capsule to mimic antibiotics
16096953|NCT02185209|Drug|Amoxicillin Sandoz|Tablet 500 mg amoxicillin Sandoz three times a day
16096954|NCT02185209|Drug|Metronidazole Sanofi|400 mg metronidazole Sanofi administered three times a day (TID)
16096955|NCT02185209|Drug|Phenoxymethylpenicillin Meda|1600 mg phenoxymethylpenicillin Meda, three time a day (TID)
16096956|NCT02185196|Drug|Vitamin D3|20,000 IU vitamin D3 in children <6 months, 50,000 IU in children 6-12 months and 1,00,000 IU in children 13-59 months of age on first day and thereafter 10,000 IU for next 4 days
16096957|NCT02185196|Drug|Placebo|20,000 IU Miglyol-oil in children <6 months, 50,000 IU in children 6-12 months and 1,00,000 IU in children 13-59 months of age on first day and thereafter 10,000 IU for next 4 days
16096958|NCT02185183|Drug|Alequel|Alequel
16096959|NCT02185170|Procedure|Trans-urethral resection|All subjects of the study are going to have a trans-urethral resection of prostate.
16096960|NCT02185170|Device|Use of the FEMTO-ST institute medical device|The FEMTO-ST institute medical device is use to detect prostatic and malignant tissue.
16096961|NCT02185170|Device|Use of the Light-CT scanner|The Light-CT Scanner is use in the tissue structural observation
16096962|NCT02185157|Other|dual -task exercises|physical exercises sections with gait and a second task like talk answering some questions or making some exercise with the arms.
16096996|NCT02184910|Drug|pepsinogen and gastrin|
16096963|NCT02185157|Other|Aerobic training|The same doses of aerobic training, i.e., 50 minutes, was delivered in groups of five participants. Each session will include 10 minutes of warm-up, 30 minutes of aerobic training on an ergometric bicycle at 60 to 80% of the participants' maximum heart rates,and 10 minutes of cool-down exercises.
16096964|NCT02185144|Behavioral|PATH For Triples|In addition to providing weekly home-health nursing focused psycho-education aimed at insuring adherence to drug treatment regimen, the nurse health navigator model provided in PFT combines continuous and integrated care across mental health, substance abuse, and infectious disease provides. The nurses will accompany the patient to appointments, or make collateral contacts with other care providers. Often the nurses serve as intermediaries and ensure accurate and timely information exchange. Their specialized training also allows them to monitor side effects of medications and advocate for the patients with their various specialty providers. A treatment cascade approach is utilized when the patient is non-adherent to treatment allowing for increased patient monitoring.
16096965|NCT02185144|Behavioral|Treatment as Usual|Control subjects receive enhanced TAU care which will consist of the opportunity to complete the full complement of baseline instruments that will then be shared with their outpatient mental health case manager to facilitate linkage with needed MH, SA, and ID care
16096966|NCT02185131|Drug|Mirtazapine|Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m. Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.
16096967|NCT02185131|Drug|Placebo|Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m. Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.
16096968|NCT02185118|Drug|oxygen|"Clinical in-vitro sepsis was induced in peripheral blood monocytes of non-septic patients by lipopolysaccharide or plasma from septic patients.
~Treatment of 100% oxygen or subanesthetic sevoflurane in 60% oxygen or subanesthetic isoflurane in 60% oxygen was performed on human peripheral blood mononuclear cells (PBMCs) stimulated by lipopolysaccharide or plasma from septic patients."
16096969|NCT02185118|Drug|Sevoflurane|"Clinical in-vitro sepsis was induced in peripheral blood monocytes of non-septic patients by lipopolysaccharide or plasma from septic patients.
~Treatment of 100% oxygen or subanesthetic sevoflurane in 60% oxygen was performed on human peripheral blood mononuclear cells (PBMCs) stimulated by lipopolysaccharide or plasma from septic patients."
16096970|NCT02185118|Drug|Isoflurane|"Clinical in-vitro sepsis was induced in peripheral blood monocytes of non-septic patients by lipopolysaccharide or plasma from septic patients.
~Treatment of 100% oxygen or subanesthetic isoflurane in 60% oxygen was performed on human peripheral blood mononuclear cells (PBMCs) stimulated by lipopolysaccharide or plasma from septic patients."
16096971|NCT02185105|Device|comfilcon A MTO|Randomized to a test lens in one eye and control lens in the other as a matched pair.
16096972|NCT02185105|Device|comfilcon A|Randomized to a test lens in one eye and control lens in the other as a matched pair.
16096973|NCT02185092|Dietary Supplement|Lactobacillus GG|probiotic supplement
16096974|NCT02185092|Other|Sugar pill|placebo
16096975|NCT02185079|Behavioral|Training to proficiency|Conventional training for epidural catheter placement as per department protocols will be given to the trainees in this arm as well.Trainees in this arm in addition will be trained to proficience based on the metrics developed for labor epidural catheter placement in a epidural simulator.
16096976|NCT02185079|Behavioral|Conventional training|Conventional training for epidural catheter placement as per department protocols will be given to the trainees in this arm. Access to epidural simulator for 2 days will be given.
16096977|NCT02185066|Drug|Atorvastatin 20mg and Metformin XR 500mg (Reference)|"Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between.
~Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between."
16096978|NCT02185066|Drug|CJ-30056 20/500mg (Test)|"Group 1 receives Atorvastatin 20mg and Metformin XR 500mg first, then CJ-30056 second, with at 7-day wash-out period in between.
~Group 2 receives CJ-30056 first, then Atorvastatin 20mg and Metformin XR 500mg second, with 7-day wash-out period in between."
16096979|NCT02185053|Drug|CPC-201|
16096980|NCT02185040|Drug|CC-220|0.3 mg oral capsules once every other day with or without food
16096981|NCT02185040|Drug|CC-220|Subjects will receive 0.3 mg oral capsules every day with or without food
16096982|NCT02185040|Drug|CC-220|CC-220 oral capsules 0.6 mg and 0.3 mg on alternating days with or without food
16096983|NCT02185040|Drug|CC-220|CC-220 oral capsule 0.6 mg QD with or without food
16096984|NCT02185040|Drug|Placebo|Matching oral placebo daily
16096985|NCT02185027|Other|complications and compliance with GIHP recommendations|Description of complications, compliance, major bleeding events, treatments, reversal strategies.
16096986|NCT02185014|Drug|Adalimumab|Adalimumab pre-filled syringe, administered by subcutaneous injection
16096987|NCT02185001|Procedure|Direct Medial Patellofemoral Ligament (MPFL) Repair|The MPFL will be repaired directly at the site of the traumatic injury.
16096988|NCT02185001|Procedure|Physical therapy|Patellar immobilization, stabilization, and strengthening under the direction and guidance of the physician and physical therapist.
16096989|NCT02184988|Biological|Botulinum purified neurotoxin, Type A|The subject is to be injected intra-muscularly into a total of five sites: the mid-line of the procures muscle, the inferomedial aspect of each corrugator muscle and the superior middle aspect of each corrugator, at least 1 cm above the bony orbital rim. Each site is injected with 0.1 ml (4U), for a total of 20 U and 0.5 ml.
16096990|NCT02184975|Procedure|Cold Knife Conization with stitches|In the research arm patients who underwent cold-knife conization of the cervix underwent hemostatic sutures laterally to the cervix, at localization of 3 and 9 hours with 2-0 vicryl thread. These sutures were held prior to the onset of cold conization of the cervix.
16096991|NCT02184975|Procedure|Cold knife Conization without stitches|In the research arm patients who underwent cold-knife conization of the cervix have not undergone hemostatic sutures laterally to the cervix, at localization of 3 and 9 hours with 2-0 vicryl thread. After patient anesthesia and routine antisepsis was performed, cold knife conization of the cervix was performed.
16096992|NCT02184949|Procedure|Percutaneous Coronary Intervention|
16096993|NCT02184949|Procedure|Primary Percutaneous Coronary Intervention|
16096994|NCT02184936|Other|standard of care|
16096995|NCT02184923|Other|presentation of visual vertical|
16096997|NCT02184897|Drug|lenograstim 10 microgram/kg/day|
16096998|NCT02184884|Device|MACE after OPCAB|
16096999|NCT02184884|Device|without MACE after OPCAB|
16097000|NCT02184871|Other|exposure to different risk factors and molecular assessment|
16097001|NCT02184858|Drug|lisinopril, ACE-inhibitor|Lisinopril 0.1mg/kg/d, titration with + 0.1mg/kg/d. Max; daily dose: 0.4mg/kg. CAVE: dose reduction in case of renal impairment
16097002|NCT02184845|Device|Implant NobelActive 3.0|
16097003|NCT02184832|Drug|Metformin|2 doses of 500 mg metformin given approximately 12 hrs apart
16097004|NCT02184832|Other|Low tryptophan diet|
16097005|NCT02184832|Other|High tryptophan diet|
16097006|NCT02184819|Drug|levosimendan|24 hour continuous infusion at the rate of 0,1 µg/kg/min
16097007|NCT02184819|Drug|Placebo|24 hour infusion at a rate of 0,1 µg/kg/min assuming that it contains study drug
16097008|NCT02184806|Procedure|orthotopic graft|(1) laparoscopy (2) ovarian fragments can be put back inside the pelvic cavity close to the natural location of the ovaries or
16097009|NCT02184806|Procedure|heterotopic graft|"put under the skin
~the ovarian fragments can be put under the skin of the abdomen"
16097010|NCT02184793|Device|EMD (Inclinomax)|EMD (electronic monitoring device) : recording the head of bed inclination degree with digital display and alarm on
16097011|NCT02184767|Drug|ADASUVE®|ADASUVE® 2.5, 5, or 10 mg
16097012|NCT02184754|Procedure|Magnetic endoscope imaging (MEI)|
16097013|NCT02184741|Drug|GB-0998|Subjects recieved GB-0998 at a dose of 400mg/kg/day for five days until the 6th gestational week.
16097014|NCT02184741|Drug|Placebo|Subjects recieved saline of the same volume as GB-0998 for five days until the 6th gestational week.
16097015|NCT02184728|Device|End-tidal CO2(portable capnometer)|End-tidal CO2(portable capnometer: EMMATM, Side stream capnometry module:Datex-Ohmeda S5 Anesthesia Monitor )levels were recorded at the time of arterial blood gas sampling.
16097016|NCT02184715|Other|virtual reality system|The participants were randomly assigned to either Group A or Group B. Group A received rehabilitation treatment and additional virtual reality system for 1 month, followed by rehabilitation treatment for 1 month; by contrast, the participants in Group B received rehabilitation treatment for 1 month, followed by rehabilitation treatment and additional virtual reality system for 1 month.
16097017|NCT02184689|Drug|fexinidazole|
16097018|NCT02184676|Biological|Analysis of early immune modifications|"blood and stool sampling in parents during pregnancy (at enrollment, i.e. 7th-8th month of pregnancy)
~cord blood sampling
~stool sampling in mothers and newborns at birth (day 7)
~blood and stool sampling in children at the age of 8, 18, 30 and 42 months"
16097019|NCT02184676|Other|Collection of clinical and socio-demographic data|"Questionnaire filled in by clinicians at enrollment and at birth
~Self-administered questionnaire filled by parents at enrollment, at birth, and then at month 8, 18, 30 and 42"
16097020|NCT02184663|Other|without APA program|Control Arm : chemotherapy alone
16097021|NCT02184663|Other|APA program|Experimental Arm : chemotherapy + APA program during 16 weeks (aerobic and muscular strength exercises)
16097022|NCT02184650|Other|Premature infants with a GA < 32 weeks|At 3 years of age: ASQ (filled in by parents)
16097023|NCT02184637|Drug|Tafenoquine|A dark pink, capsule-shaped, film-coated tablet containing 150mg tafenoquine. To be administered orally
16097024|NCT02184637|Drug|Dihydroartemisinin + Piperaquine tetraphosphate|"White, oblong, biconvex, film-coated tablet with a break-line and marked on one side with two σ letters containing 320 mg piperaquine tetraphosphate (as the tetrahydrate; PQP) and 40 mg dihydroartemisinin (DHA). To be administered orally"
16097025|NCT02184637|Drug|Artemether + Lumefantrine|"Light yellow, round tablet with NC debossed on one side and CG on the other, containing 20 mg artemether and 120 mg lumefantrine. To be administered orally"
16097026|NCT02184624|Device|ELLIPTA|Dry powder inhaler (placebo) with two blister strips. One placebo strip containing lactose monohydrate and a second placebo strip containing lactose monohydrate blended with magnesium stearate.
16097027|NCT02184624|Device|DISKUS/ACCUHALER|Placebo inhaler with one blister strip containing lactose monohydrate.
16097028|NCT02184624|Device|MDI|Placebo inhaler containing propellant (1,1,1, 2-Tetrafluoroethane).
16097029|NCT02184624|Device|TURBUHALER|Placebo inhaler containing lactose monohydrate.
16097030|NCT02184624|Device|HANDIHALER|Placebo inhaler containing lactose monohydrate in a capsule.
16097031|NCT02184624|Device|BREEZEHALER|Placebo inhaler containing lactose monohydrate in a capsule.
16097032|NCT02184611|Drug|Umeclidinium bromide|Blended with lactose and magnesium stearate dry white powder of umeclidinium 62.5 mcg to be inhaled via a NDPI
16097033|NCT02184611|Drug|Placebo|Blended with lactose and magnesium stearate dry white powder to be inhaled via a NDPI
16097034|NCT02184598|Behavioral|Cognitive training|12 weeks of cognitive training; 4 sessions/week; duration 30 min
16097035|NCT02184598|Behavioral|Placebo cognitive training|In the control group, we will use a placebo training that will consist of the same exposure time of the active training but not related to any element of cognitive training. To this end, we will set up an online platform with quiz and educational videos - being the most related to school content - without any component of executive function or working memory.
16097036|NCT02184585|Drug|Treatment sequence A|FDC 1 - Fixed dose combination capsule of dutasteride and tamsulosin hydrochloride (0.5 mg/0.2 mg). Each capsule will contain dutasteride (0.5 mg) (CJ) and tamsulosin pellets (0.2 mg) version 1.
16097037|NCT02184585|Drug|Treatment sequence B|FDC 2 - Fixed dose combination capsule of dutasteride and tamsulosin hydrochloride (0.5 mg/0.2 mg). Each capsule will contain dutasteride (0.5 mg) (CL) and tamsulosin pellets (0.2 mg) version 2.
16097038|NCT02184585|Drug|Treatment sequence C|Co-administration of dutasteride 0.5 mg capsule (Oblong, size 6, dull yellow capsules: Commercially available) and tamsulosin hydrochloride 0.2 mg tablet (White, round standard convex tablet: Commercially available).
16097039|NCT02184572|Biological|Priorix|1 dose administered subcutaneously in the triceps region of left arm at Day 0
16097040|NCT02184572|Biological|M-M-R II|1 dose administered subcutaneously in the triceps region of left arm at Day 0
16097041|NCT02184572|Biological|Varivax|1 dose administered subcutaneously in the triceps region of right arm at Day 0
16097042|NCT02184572|Biological|Havrix|1 dose administered intramuscularly in the anterolateral region of the right thigh at Day 0
16097043|NCT02184572|Biological|Prevnar 13|1 dose administered intramuscularly in the anterolateral region of the left thigh at Day 0 to subjects recruited in US
16097044|NCT02184559|Drug|Ropivacaine|comparaison of two methods of administration for analgesia using the same drugs in the same indication after Caesarean section
16097045|NCT02184559|Device|The infiltration continues catheter|
16097046|NCT02184533|Drug|sodium selenite|Given PO
16097047|NCT02184533|Radiation|radiation therapy|Undergo radiation therapy
16097048|NCT02184533|Other|laboratory biomarker analysis|Correlative studies
16097049|NCT02184533|Other|pharmacological study|Correlative studies
16097050|NCT02184533|Other|questionnaire administration|Ancillary studies
16097051|NCT02184520|Device|TRANSITION|
16097052|NCT02184520|Device|REVERE|
16097053|NCT02184507|Dietary Supplement|Supplement pre CABG|One sachet of the supplement was consumed daily for 7 days before surgery.
16097054|NCT02184507|Dietary Supplement|Supplement post CABG|One sachet of the supplement was consumed daily for 30 days after surgery
16097055|NCT02184507|Dietary Supplement|Supplement pre and post CABG|One sachet of the supplement was consumed daily for 7 days before surgery and 30 days after CABG
16097056|NCT02184507|Drug|Placebo|One sachet of placebo was consumed daily for 7 days before surgery and 30 days after CABG
16097057|NCT02184494|Device|pro5 AIRdaptive Power Plate (Badhoevedorp, The Netherlands)|"Subjects will be exposed to vertical vibration with a frequency and peak-to-peak displacement of 30 Hz and 1 mm, respectively, which provides a peak-to-peak acceleration of about 4.16 G.
~Whole Body Vibration"
16097058|NCT02184481|Behavioral|Working memory training|
16097059|NCT02184481|Behavioral|Placebo training|
16097060|NCT02184468|Other|Simultaneously dispatch of firefighters and/or police in case of OHCA|In case of OHCA, firefighters and/or police trained in CPR and equipped with AEDs will be dispatched in parallel with EMS in nine counties in Sweden.
16097061|NCT02184455|Biological|DermGEN|DermGEN is a product created by a patented process that decellularizes and sterilizes donated human tissue.
16097062|NCT02184442|Device|TAVR Implantation with SAPIEN XT|Inoperable operable patients requiring the transcatheter aortic heart valve replacement
16097063|NCT02184442|Device|TAVR Implantation with SAPIEN|Inoperable operable patients requiring the transcatheter aortic heart valve replacement
16097064|NCT02184429|Drug|PF-06669571|Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 0.2 mg 0.4 mg, 0.75 mg, 1.50 mg and placebo
16097065|NCT02184429|Drug|PF-06669571|Single ascending doses of PF-06669571 as extemporaneously prepared solution/suspension, once week in a cross over study: 3 mg 6 mg, 10 mg, 3 mg (fed) and placebo
16097066|NCT02184429|Drug|PF-06669571|Oral dosing of 0.15 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days
16097067|NCT02184429|Drug|PF-06669571|Oral dosing of 0.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days
16097068|NCT02184429|Drug|PF-06669571|Oral dosing of 1.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days. This dose may be reached by a titration scheme
16097069|NCT02184429|Drug|PF-06669571|Oral dosing of 4.5 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule formulation for 14 days. This dose may be reached by a titration scheme
16097070|NCT02184429|Drug|PF-06669571|Oral dosing of 9.0 mg PF-06669571 as extemporaneously prepared solution/suspension or powder in capsule for 14 days. This dose may be reached by a titration scheme
16097071|NCT02184416|Other|observational|The study is non interventional. All drugs will be prescribed
16097072|NCT02184390|Other|On LIne Parent Training Tutorial|Interactive on line tutorial for parenting skills for autism
16097073|NCT02184364|Drug|Low dose of Klimadynon®|
16097074|NCT02184364|Drug|Medium dose of Klimadynon®|
16097075|NCT02184364|Drug|High dose of Klimadynon®|
16097076|NCT02184364|Drug|Oestrofeminal®|
16097077|NCT02184364|Drug|Placebo|
16097078|NCT02184351|Drug|Roxanes's clotrimazole troches|
16097079|NCT02184351|Drug|Mycelex® troches|
16097080|NCT02184338|Drug|BIBR 1017 BS powder|
16097081|NCT02184338|Drug|Placebo|PEG 400
16097082|NCT02184325|Drug|Kiddi® Pharmaton Fizz, effervescent tablets|
16097083|NCT02184325|Drug|Kiddi® Pharmaton Fizz, effervescent tablets: marketed formula|
16097084|NCT02184325|Drug|Comparator product|active substances: Vitamin A, Vitamin B1, Vitamin B2, Vitamin B5, Vitamin B6, Vitamin B12, Vitamin C, Vitamin D, Vitamin E, Manganese, Copper, Calcium, Magnesium, Phosphorous, Iron, Zinc, Sodium, Molybden
16097085|NCT02184312|Drug|Nevirapine XR low dose|
16097086|NCT02184312|Drug|Nevirapine XR medium dose|
16097087|NCT02184312|Drug|Nevirapine XR high dose|
16097088|NCT02184312|Drug|Nevirapine (VIRAMUNE®)|
16097089|NCT02184299|Drug|Nevirapine|
16097090|NCT02184299|Drug|Prednisone|
16097091|NCT02184286|Drug|Nevirapine|200 mg q.d. days 1-14 followed by 200 mg b.i.d. days 15-28
16097092|NCT02184286|Drug|Saquinavir-sgc|1600 mg b.i.d. from pre trial to day 28
16097093|NCT02184273|Drug|Magnesium metamizol|
16097094|NCT02184273|Drug|Placebo|
16097095|NCT02184260|Drug|Metamizole|
16097096|NCT02184260|Drug|Placebo|
16097097|NCT02184247|Drug|anhydrous theophylline, 350 mg|
16097098|NCT02184247|Drug|anhydrous theophylline, 300 mg|
16097099|NCT02184234|Drug|Antistax film coated tablets|
16097100|NCT02184221|Device|High frequency stimulation|The parameter of DMS: alpha frequency
16097101|NCT02184221|Device|Low frequency stimulation|The parameter of DMS: 0.5Hz
16097102|NCT02184195|Drug|Olaparib|Tablet -100mg
16097103|NCT02184195|Drug|Olaparib|Tablet-150mg
16097104|NCT02184195|Drug|Placebo|Match Olaparib 100mg placebo
16097105|NCT02184195|Drug|Placebo|Match Olaparib 150mg placebo
16097152|NCT02183779|Procedure|cooling box|
16097153|NCT02183779|Drug|L-NMMA and Fluconazole dermic injection|
16097154|NCT02183766|Dietary Supplement|Galactooligosaccharide prebiotic|6 mL once a day
16097155|NCT02183766|Drug|Maltodextrin|6 mL once a day
16097106|NCT02184182|Procedure|VLS ablation/portal ligation/hepatectomy|"Step1:
~exploratory laparoscopy to exclude extrahepatic disease
~right portal vein ligation if surgically feasible
~RF/MW ablation on the future line of transection (of segment 4 close to left lateral lobe)
~radiological portal embolization within 48h form the laparoscopic procedure if the right portal vein ligation is not feasible
~CT volumetric scan to evaluate the left lateral lobe hypertrophy after 9±2 from Step 1
~Step 2: only if FRL/body weight > 0.5
~- laparoscopic/laparotomic right trisectionectomy"
16097107|NCT02184169|Device|General Electric Healthcare E-COVX Gas Monitoring Module for VO2 Measurments|Breath to breath VO2 measurements
16097108|NCT02184169|Device|Edwards Continuous SVO2 Catheter and Monitoring System - 4.5 fr|Edwards continuous SVO2 measurement system
16097109|NCT02184156|Biological|Ampion <5 kDa ultrafiltrate of 5% human serum albumin|4 mL intra-articular injection of Ampion
16097110|NCT02184156|Biological|Placebo|Saline
16097111|NCT02184143|Behavioral|CBPT|Changing Behavior through Physical Therapy (CBPT) is a cognitive-behavioral based self-management program.
16097112|NCT02184143|Other|Education|Patient education
16097113|NCT02184130|Other|transcranial magnetic stimulation and motion stimuli|
16097114|NCT02184117|Drug|Adenosine|Intracoronary or intravenous adenosine to induce hyperemia for reference FFR
16097115|NCT02184117|Drug|Contrast Media|"Intracoronary injection of contrast medium to induce hyperemia for contrast FFR"
16097116|NCT02184117|Drug|Resting conditions|Baseline measurement of aortic and coronary pressures
16097117|NCT02184104|Dietary Supplement|Caffeine|
16097118|NCT02184091|Drug|Nevirapine|
16097119|NCT02184078|Drug|Nevirapine|
16097120|NCT02184078|Drug|Rifabutin|
16097121|NCT02184065|Drug|Meloxicam|
16097122|NCT02184052|Drug|Meloxicam|7.5 mg or 15 mg
16097123|NCT02184026|Behavioral|Exposure, Relaxation, & Rescripting Therapy-Child|Exposure, Relaxation, & Rescripting Therapy (ERRT) will be conducted once a week for five consecutive weeks for approximately two hours per session. Each treatment session focuses on one of the following topics/skills: psycho-education and investment in treatment, psycho-education, Progressive Muscle Relaxation, diaphragmatic breathing, child-friendly exposure to the trauma-nightmare, and rescription.
16097124|NCT02184013|Procedure|Catheter ablation|Catheter ablation (in addition ot PVI) guided by ECGI mapping, and atrial fibrosis mapping (DE-MRI).
16097125|NCT02183987|Other|Active Knowledge Translation Intervention|"Access to CSN guidelines, & provider- & patient-directed infographics recommending an intent-to-defer dialysis initiation strategy will be displayed in prominent clinic wall space & disseminated to patients.
~Educational whiteboard video will be made available as a resource for clinic staff & patients.
~Each clinic will receive reports from the Canadian Organ Replacement Register (CORR) outlining the proportion of patients followed by a Nephrologist (>3 months) starting dialysis early (eGFR >10.5 ml/min), for all incident dialysis patients from the clinic, with provincial & national average comparisons. These reports, & the CSN guideline on timing of dialysis initiation recommendation, will be delivered to the medical lead for each CKD clinic.
~Each clinic will receive an in-person visit from one of the study investigators/collaborators highlighting the clinical practice guidelines & evidence supporting an intent-to-defer strategy, & will receive follow-up."
16097126|NCT02183974|Procedure|Peptest|
16097127|NCT02183961|Other|Restech|
16097128|NCT02183961|Other|Peptest|
16097129|NCT02183961|Other|Detection of pepsin in adenoid specimen|
16097130|NCT02183948|Drug|Oxytocin|
16097131|NCT02183948|Drug|Placebo|
16097132|NCT02183935|Device|Duodena-jejunal liner|
16097133|NCT02183922|Dietary Supplement|microencapsulated conjugated linoleic acid|The microencapsulated conjugated linoleic acid received light fruit jam with microencapsulated conjugated linoleic acid (3 g/day) during 12 weeks.
16097134|NCT02183922|Dietary Supplement|microencapsulated fish oil|The microencapsulated fish oil group received light fruit jam with microencapsulated fish oil (3 g/day) during 12 weeks.
16097135|NCT02183922|Dietary Supplement|light fruit jam|The placebo group received light fruit jam (15 g/day) during 12 weeks.
16097136|NCT02183909|Other|Testing and linkage to care for Y/MSM|Implementation of strategies to enhance testing and linkage to care of Y/MSM, including social network testing and a youth outreach corps working with existing and new community partner agencies.
16097137|NCT02183909|Behavioral|Engagement and retention for HIV-positive Y/MSM in care|Optimizing current HIV care and treatment services at DYC by implementing a patient peer mentoring component, a linkage and retention specialist, and psychosocial support for program staff.
16097138|NCT02183909|Other|Engagement and retention for HIV-negative Y/MSM in sexual health services|Offering a highly effective combination HIV prevention strategy, including PrEP; warm-hand offs for high-risk negatives, nPEP; risk reduction counseling; frequent HIV and STI testing, including testing a highly sensitive method of detecting early HIV infection; and youth-focused programming.
16097139|NCT02183909|Drug|Stribild PEP Substudy|A substudy of 28 days of once-daily Stribild® initiated within 72 hours of a high risk sexual exposure for HIV post-exposure prophylaxis (PEP).
16097140|NCT02183896|Biological|Platelet-rich plasma (PRP)|
16097141|NCT02183896|Drug|Saline|
16097142|NCT02183883|Drug|Afatinib|"40mg, 30mg, 20mg, OD, taken until progression, unacceptable toxicity, intercurrent illness, patient/clinician decision.
~EGFR positive mutation patients only: dose escalation to a maximum of 50 mg/day may be considered in patients who tolerate a 40 mg/day dose (i.e. absence of diarrhoea, skin rash, stomatitis, and other adverse reactions with CTCAE Grade > 1) in the first 3 weeks. The dose should not be escalated in any patients with a prior dose reduction. The maximum daily dose for EGFR mutation positive patients is 50 mg."
16097143|NCT02183870|Drug|Crizotinib|250mg crizotinib bid until end of treatment
16097144|NCT02183857|Device|Ultrasound|
16097145|NCT02183857|Other|Landmark|
16097146|NCT02183844|Behavioral|Psychosocial Weight Intervention|Weekly group intervention for diet and exercise, designed specifically for individuals with serious mental illness and the cognitive deficits that accompany those illnesses
16097147|NCT02183831|Device|Insertion of the capsular tension ring|
16097148|NCT02183805|Drug|Abraxane,Cyclophosphamide,Carboplatin|High dose chemotherapy: Abraxane, Cyclophosphamide, Carboplatin
16097149|NCT02183792|Drug|Tolvaptan|
16097150|NCT02183792|Drug|Furosemide|
16097151|NCT02183779|Procedure|post-occlusive hyperemia|
16097158|NCT02183740|Behavioral|Multifaceted educational program|
16097159|NCT02183727|Device|L-C Ligament|The L-C Ligament is a bioresorbable, three-dimensional (3-D) braided scaffold made from poly L-lactic acid (PLLA) fiber. One device is used to replace the ACL. The L-C Ligament is an interventional device. The L-C Ligament is comprised of three regions: (1) The femoral tunnel attachment site, (2) The ligament region (intra-articular zone), and (3) The tibial tunnel attachment site. For several months after surgery, the L-C Ligament replaces the function of the ACL. During this time, ligament tissue regenerates within and around the L-C Ligament, which is slowly absorbed and replaced by the ACL.
16097160|NCT02183727|Procedure|Hamstring Autograft|The gold-standard treatment for ACL reconstruction is autograft tissue. Autograft is a piece of tendon harvested from another part of the patient's body, such as the hamstring or kneecap. In this study, the hamstring tendon from the back of the thigh of the injured (target) leg will be harvested and surgically transferred to replace the torn ACL. The attachment of the autologous tendon in the femoral and tibial bone tunnels will utilize techniques that are similar to those for the L-C Ligament. Over time the replacement tendon resorbs and a new ACL is regenerated.
16097161|NCT02183714|Drug|Songha Night ®|
16097162|NCT02183714|Drug|Placebo|
16097163|NCT02183701|Drug|Telmisartan|
16097164|NCT02183701|Drug|Losartan + Hydrochlorothiazide|
16097165|NCT02183701|Drug|Placebo|
16097166|NCT02183688|Drug|Low dose ASA|
16097167|NCT02183688|Drug|High dose ASA|
16097168|NCT02183688|Drug|Low dose paracetamol|
16097169|NCT02183688|Drug|High dose paracetamol|
16097170|NCT02183688|Drug|Caffeine|
16097171|NCT02183688|Drug|Placebo|
16097172|NCT02183675|Drug|Telmisartan/Amlodipine|Telmisartan/Amlodipine fixed-dose combination
16097173|NCT02183675|Drug|Telmisartan/Amlodipine/HCTZ|Telmisartan/Amlodipine/HCTZ fixed-dose combination
16097174|NCT02183675|Drug|Telmisartan/HCTZ|Telmisartan/HCTZ fixed-dose combination
16097175|NCT02183662|Drug|BI 224436|
16097176|NCT02183662|Drug|Placebo to BI 224436|
16097177|NCT02183649|Drug|pentoxyverine citrate|
16097178|NCT02183649|Drug|Placebo|
16097179|NCT02183636|Drug|Linagliptin/pioglitazone, FDC formulation C5|film coated tablet (5 mg/45 mg)
16097180|NCT02183636|Drug|Linagliptin/pioglitazone, FDC formulation C8|film coated tablet (5 mg/45 mg)
16097181|NCT02183636|Drug|Linagliptin tablet|5 mg
16097182|NCT02183636|Drug|pioglitazone tablet (Actos®)|45 mg
16097183|NCT02183623|Drug|Simvastatin|
16097184|NCT02183623|Drug|10 mg BI 1356 BS|
16097185|NCT02183610|Drug|[14C] BI 1356 as oral (p.o.) solution|
16097186|NCT02183610|Drug|[14C] BI 1356 solution for i.v. infusion|
16097187|NCT02183584|Drug|Rifampicin|
16097188|NCT02183584|Drug|Linagliptin|
16097189|NCT02183571|Drug|Merck Glucophage® high dose|Part I: Treatment A
16097190|NCT02183571|Drug|BMS Glucophage® high dose|Part I: Treatment B
16097191|NCT02183571|Drug|Merck Glucophage® low dose|Part II: Treatment C
16097192|NCT02183571|Drug|BMS Glucophage® low dose|Part II: Treatment D
16097193|NCT02183558|Other|OGTT by randomization|
16097194|NCT02183558|Other|OGTT by indication|
16097195|NCT02183545|Drug|BI 1060469|single rising doses given as tablet
16097196|NCT02183545|Drug|Placebo|given as tablet (matching placebo of BI 1060469)
16097197|NCT02183532|Drug|BI 1356 BS|single dose
16097198|NCT02183532|Drug|BI 1356 BS|multiple doses
16097199|NCT02183519|Drug|Capsaicin|For reflex cough testing, all participants will receive various concentrations of nebulized capsaicin. Delivery of multiple concentrations and doses of capsaicin allows for accurate assessment of both the strength (airflow measures) of reflex, as well as cough sensitivity.
16097200|NCT02183519|Other|Voluntary cough test|Participants will be fitted with a facemask covering their mouth and nose, and instructed to cough into the facemask.
16097201|NCT02183506|Drug|Metformin|
16097202|NCT02183506|Drug|BI 1356 BS|
16097203|NCT02183493|Drug|BI 1356|
16097204|NCT02183480|Drug|Linagliptin, low dose|
16097205|NCT02183480|Drug|Linagliptin, medium dose|
16097206|NCT02183480|Drug|Linagliptin, high dose|
16097207|NCT02183467|Drug|BI 1356, low dose|
16097208|NCT02183467|Drug|BI 1356, high dose|
16097209|NCT02183467|Drug|Placebo|
16097210|NCT02183467|Drug|Moxifloxacin|
16097211|NCT02183454|Device|OrbusNeich COMBO stent|The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.
16097212|NCT02183441|Drug|BI 1356|
16097213|NCT02183441|Drug|Ritonavir|
16097214|NCT02183428|Drug|BI 1356|
16097215|NCT02183428|Drug|Glyburide|
16097216|NCT02183428|Drug|BI 1356 + Glyburide|
16097217|NCT02183415|Drug|BI 1356 BS, low dose|
16097218|NCT02183415|Drug|BI 1356 BS, medium dose|
16097219|NCT02183415|Drug|BI 1356 BS, high dose|
16097220|NCT02183415|Drug|Placebo|
16097221|NCT02183402|Drug|Digoxin|
16097222|NCT02183402|Drug|BI 1356|
16097223|NCT02183389|Drug|Warfarin|
16097224|NCT02183389|Drug|BI 1356|
16097225|NCT02183376|Drug|BI 1356|
16097226|NCT02183363|Drug|BI 1356 - Tablet TFII|
16097227|NCT02183363|Drug|BI 1356 - Tablet iFF|
16097228|NCT02183363|Drug|BI 1356 - Tablet TFIIb|
16097229|NCT02183350|Drug|BI 1356 BS - single rising dose|
16097230|NCT02183350|Drug|Placebo|
16097231|NCT02183337|Drug|BI 1356|
16097232|NCT02183337|Drug|BI 1356 + Pioglitazone|
16097233|NCT02183337|Drug|Pioglitazone|
16097234|NCT02183324|Drug|Low dose of BI 1356 BS|
16097235|NCT02183324|Drug|Medium dose of BI 1356 BS|
16097236|NCT02183324|Drug|High dose of BI 1356 BS|
16097237|NCT02183324|Drug|Placebo|
16097238|NCT02183311|Drug|BI 1356 BS - single rising dose|
16097239|NCT02183311|Drug|BI 1356 BS - multiple rising dose|
16097240|NCT02183311|Drug|Placebo|
16097241|NCT02183298|Drug|BI 1356 BS - intravenous|
16097242|NCT02183298|Drug|BI 1356 BS - Tablet|
16097243|NCT02183298|Drug|Placebo|
16097244|NCT02183285|Dietary Supplement|Pharmaton PHL 00747 soft gelatine capsules|
16097245|NCT02183285|Dietary Supplement|Pharmaton PHL 00747 film-coated tablets|
16097246|NCT02183285|Dietary Supplement|Placebo film-coated tablets (fct)|
16097247|NCT02183285|Dietary Supplement|Placebo soft gelatine capsules|
16097248|NCT02183272|Drug|Intranasal Ketamine|Ketamine in liquid form to be distributed nasally by a board-certified physician while the subject is already in the hospital for suicidal ideation.
16097249|NCT02183272|Drug|Intranasal Saline Placebo|Intranasal Saline to be distributed by a board-certified physician while the patient is already hospitalized for suicidal ideation.
16097250|NCT02183259|Drug|ESR 1150 CL, Capsule, oral|
16097251|NCT02183259|Drug|ESR 1150 CL, solution, intravenous|
16097252|NCT02183246|Drug|Porfiromycin|
16097253|NCT02183246|Drug|Placebo|
16097254|NCT02183246|Radiation|Radiotherapy|
16097255|NCT02183233|Drug|Eschscholtzia Californica|
16097256|NCT02183233|Drug|Eschscholtzia Californica Placebo|
16097257|NCT02183220|Drug|Metamizol|
16097258|NCT02183220|Drug|Acetylsalicylic acid (ASA)|
16097259|NCT02183220|Drug|Metamizol placebo|
16097260|NCT02183220|Drug|ASA placebo|
16097261|NCT02183207|Procedure|Percutaneous Endoscopic Gastrostomy|Percutaneous Endoscopic Gastrostomy by introducer method via visualization through E.G. ScanTM
16097262|NCT02183194|Device|Lutonix Paclitaxel Drug Coated Balloon|
16097263|NCT02183181|Drug|Meloxicam capsule|
16097264|NCT02183181|Drug|Meloxicam tablet|
16097265|NCT02183168|Drug|Meloxicam suppository|
16097266|NCT02183168|Drug|Meloxicam tablet|
16097267|NCT02183168|Drug|Indomethacin|
16097268|NCT02183155|Drug|Meloxicam - low|
16097269|NCT02183155|Drug|Meloxicam - medium|
16097270|NCT02183155|Drug|Meloxicam - high|
16097271|NCT02183155|Drug|Placebo|
16097272|NCT02183155|Drug|Extended-release indomethacin|
16097273|NCT02183142|Drug|Mobic, China, 7.5 mg|
16097274|NCT02183142|Drug|Mobic, Germany, 7.5 mg|
16097275|NCT02183129|Drug|Diclofenac|
16097276|NCT02183129|Drug|Meloxicam|
16097277|NCT02183116|Drug|Meloxicam|
16097278|NCT02183103|Drug|meloxicam rapid release tablet, 12mg, UH AC62MU|
16097279|NCT02183090|Drug|Meloxicam ampoule|
16097280|NCT02183090|Drug|Meloxicam tablet|
16097281|NCT02183077|Drug|Meloxicam gel|
16097282|NCT02183077|Drug|Meloxicam tablet|
16097283|NCT02183064|Drug|Meloxicam|
16097284|NCT02183064|Drug|NSAID|
16097285|NCT02183051|Drug|Meloxicam 7.5 mg|
16097286|NCT02183051|Drug|Meloxicam 3.75 mg|
16097287|NCT02183051|Drug|Meloxicam 1.875 mg|
16097288|NCT02183051|Drug|Ibuprofen 200 mg|
16097289|NCT02183051|Drug|Placebo|
16097290|NCT02183051|Drug|Meloxicam 15 mg|
16097291|NCT02183051|Drug|Ibuprofen 400 mg|
16097292|NCT02183038|Drug|Meloxicam low|
16097293|NCT02183038|Drug|Meloxicam high|
16097294|NCT02183038|Drug|Naproxen sodium|
16097295|NCT02183038|Drug|Meloxicam placebo low|
16097296|NCT02183038|Drug|Meloxicam placebo high|
16097297|NCT02183038|Drug|Naproxen sodium placebo|
16097298|NCT02183025|Drug|Meloxicam 7.5 mg|
16097299|NCT02183025|Drug|Meloxicam 15 mg|
16097300|NCT02183025|Drug|Mefenamic acid 500 mg|
16097301|NCT02183025|Drug|Placebo matching 7.5 mg meloxicam|
16097302|NCT02183025|Drug|Placebo matching 15 mg meloxicam|
16097303|NCT02183025|Drug|Placebo matching 500 mg mefenamic acid|
16097304|NCT02183012|Drug|Ibuprofen extrudate|
16097305|NCT02183012|Drug|Ibuprofen lysinate|
16097306|NCT02183012|Drug|Ibuprofen|
16097307|NCT02182999|Device|Wound infiltration catheter|Wound catheter with multiple and laterally aligned holes is inserted through the intact skin via an 16G iv catheter 2 cm proximal-laterally from the proximal end of the dorsomedial skin incision and placed subcutaneously through the wound and medially around the first metatarsal so that the tip projects into the interdigital space 1/2.
16097308|NCT02182999|Drug|NaCl 0.9%|The catheter is connected to the perfusor line filled with saline 0.9% to allow continuous wound infiltration at a rate of 2 ml/h for 24 hours.
16097309|NCT02182999|Drug|Ropivacaine 0.2%|The catheter is connected to the perfusor line filled with Ropivacaine 0.2% to allow continuous wound infiltration at a rate of 2 ml/h for 24 hours.
16097310|NCT02182986|Procedure|transplant|All subjects enrolled in this study are candidates for/recipients of solid organ transplants as a therapeutic for end stage diseases (e.g., heart, liver, heart with liver, kidney, small intestine, or liver with small intestine transplants).
16097311|NCT02182986|Drug|Immunosuppressive Drugs|Immunosuppressive drugs prescribed as standard of care to prevent rejection of the allograft.
16097312|NCT02182973|Dietary Supplement|donor human milk|"Infants with NAS requiring pharmacologic management will be fed donor human milk instead of formula for 2 weeks.
~GI-subscores from the Finnegan NAS Scoring system will be computed."
16097313|NCT02182960|Drug|Ibuprofen syrup|
16097314|NCT02182960|Drug|Brufen syrup|
16097315|NCT02182947|Device|Capsule endoscopy|Pediatric patients with indeterminate colitis (IC) or Crohn's disease (CD) who are scheduled to undergo routine small bowel screening or surveillance using MRE. Subjects will swallow a patency capsule (PC) to study bowel patency.Those patients, who pass an intact PC, usually within 40 hours, will ingest the wireless capsule endoscopy (WCE). The WCE will be performed within 1 week of completion of MRE.
16097316|NCT02182934|Drug|Ginsana|
16097317|NCT02182934|Drug|Placebo|
16097318|NCT02182908|Other|PET-Scan|PET-Scan
16097319|NCT02182895|Drug|Saxagliptin|2.5-5 mg daily
16097320|NCT02182882|Drug|GINSANA|
16097321|NCT02182882|Drug|Placebo|
16097322|NCT02182869|Drug|Combivent® HFA inhalation aerosol|
16097323|NCT02182869|Drug|Combivent® CFC inhalation aerosol|
16097324|NCT02182856|Drug|Ipratropium bromide 500 µg/salbutamol sulphate 3 mg|
16097325|NCT02182856|Drug|Ipratropium 500 µg|
16097326|NCT02182856|Drug|Salbutamol sulphate 3 mg|
16097327|NCT02182856|Drug|Salbutamol sulphate 6 mg|
16097328|NCT02182843|Biological|Cellentra VCBM|Cellentra™ VCBM is an allogenic bone graft containing naturally occurring viable donor cells intended for homologous use in the repair, replacement, reconstruction or supplementation of the recipient's tissue in musculoskeletal defects.
16097329|NCT02182830|Drug|Empagliflozin low dose|starting dose 10mg; forced titration after 4 weeks 25mg dose
16097330|NCT02182830|Drug|placebo|starting dose 10mg; forced titration after 4 weeks 25mg dose
16097331|NCT02182830|Drug|Empagliflozin high dose|starting dose 10mg; forced titration after 4 weeks 25mg dose
16097332|NCT02182804|Device|Olympus|narrow band imaging with magnification
16097333|NCT02182804|Device|Cellvizio|probe-based confocal laser endomicroscopy
16097334|NCT02182791|Drug|Nevirapine|
16097335|NCT02182791|Drug|EE/NET|
16097336|NCT02182778|Drug|Gemcitabine/Cisplatin|Gemcitabine and cisplatin are infused on day1, 8. The cycle is repeated every 3 weeks.
16097337|NCT02182778|Drug|Gemcitabine/Cisplatin /S-1|S-1 is given daily for 7 consecutive days and gemcitabine and cisplatin are infused on day1. The cycle is repeated every 2 weeks.
16097338|NCT02182765|Drug|Nevirapine|
16097339|NCT02182765|Drug|Amprenavir|
16097340|NCT02182765|Drug|Abacavir|
16097341|NCT02182752|Drug|Ropivacaine - Tramadol|Interscalene block using ropivacaine plus tramadol
16097342|NCT02182752|Drug|Ropivacaine|Interscalene block using ropivacaine
16097343|NCT02182739|Drug|Meloxicam|tablets or injectable solution
16097344|NCT02182726|Drug|MOBEC|
16097345|NCT02182713|Drug|Salbutamol sulfate/Ipratropium bromide|Salbutamol sulfate 120 mcg + Ipratropium bromide 20 mcg per puff
16097346|NCT02182713|Drug|Salbutamol|Salbutamol 100 mcg per puff
16097347|NCT02182700|Drug|salbutamol sulfate + ipratropium bromide|120 mcg (salbutamol sulfate) + 20 mcg (ipratropium bromide), inhalation (metered aerosol plus spacer)
16097348|NCT02182687|Radiation|Stereotactic Body Radiation Therapy (SBRT)|SBRT will be delivered in five total fractions, with at a minimum of one day between any two treatments. The entire treatment must be delivered within 15 total days.
16097349|NCT02182687|Procedure|Trans-Arterial Chemoembolization (TACE)|First day will be administered and a second TACE will be administered after 4 weeks and subsequently if imaging is showing disease progression. Following each TACE procedure all patients will remain in hospital for observation.
16097350|NCT02182687|Drug|Doxorubin|This procedure will be completed with 2 vials of drug eluting beads each loaded with 50 mg of Doxorubin.
16097351|NCT02182674|Drug|Placebo Combivent HFA|
16097352|NCT02182674|Drug|Combivent HFA|
16097353|NCT02182674|Drug|Combivent (CFC)|
16097354|NCT02182674|Drug|Placebo Combivent (CFC)|
16097355|NCT02182661|Drug|Ba253BINEB|
16097356|NCT02182648|Drug|etomidate|"intravenous injection midazolam 0.08 mg/kg, fentanyl 0.002 mg/kg, cisatracurium 0.15 mg/kg for induction of anesthesia.
~infusion of etomidate at 2 minutes before anesthesia induction"
16097357|NCT02182648|Drug|propofol|"intravenous injection midazolam 0.08 mg/kg, fentanyl 0.002 mg/kg, cisatracurium 0.15 mg/kg for induction of anesthesia.
~infusion of propofol at 2 minutes before anesthesia induction"
16097358|NCT02182648|Drug|sevoflurane|"intravenous injection midazolam 0.08 mg/kg, fentanyl 0.002 mg/kg, cisatracurium 0.15 mg/kg for induction of anesthesia.
~inhale sevoflurane for anesthesia induction and maintenance"
16097359|NCT02182635|Drug|Ba253BINEB|
16097360|NCT02182622|Drug|Docetaxel|
16097361|NCT02182622|Drug|Prednisone|
16097362|NCT02182622|Drug|LDE225|
16097363|NCT02182609|Drug|Kit for the Preparation of 99mTc-rhAnnexin V-128|Kit for the Preparation of Tc-99m Recombinant Human Annexin V-128 for Injection
16097364|NCT02182596|Drug|Mylotarg|Dose level study
16097365|NCT02182583|Drug|Ba253MDI|
16097366|NCT02182583|Drug|Ba253BINEB|
16097367|NCT02182570|Drug|WAL 801 CL dry syrup|
16097368|NCT02182557|Drug|WAL 801 CL Dry Syrup|
16097369|NCT02182557|Drug|Ketotifen Fumarate Dry Syrup|
16097370|NCT02182557|Drug|WAL 801 CL Dry Syrup placebo|
16097371|NCT02182557|Drug|Ketotifen Fumarate Dry Syrup placebo|
16097372|NCT02182544|Drug|WAL801CL dry syrup|
16097373|NCT02182544|Drug|Ketotifen fumarate dry syrup|
16097374|NCT02182544|Drug|Ketotifen fumarate dry syrup placebo|
16097375|NCT02182544|Drug|WAL 801 CL dry syrup placebo|
16097376|NCT02182531|Drug|Epinastine|
16097377|NCT02182531|Drug|Pseudoephedrine|
16097378|NCT02182531|Drug|Epinastine + Pseudoephedrine combination|
16097379|NCT02182518|Drug|Epinastine|
16097380|NCT02182518|Drug|Pseudoephedrine|
16097381|NCT02182518|Drug|Placebo|Placebo during run-in period
16097382|NCT02182505|Drug|Berodual® Respimat®, low dose|
16097383|NCT02182505|Drug|Berodual® Respimat®, high dose|
16097384|NCT02182505|Drug|Berodual® MDI|
16097385|NCT02182492|Drug|Clarithromycin|Clarithromycin 250 mg tablet once daily for 3 months
16097386|NCT02182492|Drug|Glucocorticoid|Fluticasone propionate nasal spray 200 μg/d for 3 months
16097387|NCT02182479|Drug|Berodual® via Respimat®, high dose|
16097388|NCT02182479|Drug|Berodual® via Respimat®, low dose|
16097389|NCT02182479|Drug|Berodual® via MDI, high dose|
16097390|NCT02182479|Drug|Placebo Respimat®|
16097391|NCT02182479|Drug|Placebo MDI|
16097392|NCT02182466|Device|Colon capsule endoscopy|
16097393|NCT02182453|Drug|BI 10773 - single rising dose|
16097394|NCT02182453|Drug|Placebo|
16097395|NCT02182440|Biological|recAP|One hour infusions once daily for three days
16097396|NCT02182440|Other|Placebo|1 hour IV infusion once daily for 3 days
16097397|NCT02182414|Drug|BI 207127 NA (TF-I)|200 mg tablet
16097398|NCT02182414|Drug|BI 207127 NA (TF-II)|400 mg tablet
16097399|NCT02182414|Drug|BI 207127 NA delayed release|400 mg tablet
16097400|NCT02182414|Drug|BI 207127 NA extended release (10% HPMC)|400 mg tablet
16097401|NCT02182414|Drug|BI 207127 NA extended release (15% PEO)|400 mg tablet
16097402|NCT02182414|Drug|BI 207127 NA extended release (20% HPMC)|400 mg tablet
16097403|NCT02182401|Drug|BI 207127 NA|Days 3-8 and days 25-30
16097404|NCT02182401|Drug|BI 201335 NA|Days 15-30
16097405|NCT02182401|Drug|Midazolam|Days 1, 7, 23 and 29
16097406|NCT02182401|Drug|Tolbutamide|Days 1, 7, 23 and 29
16097407|NCT02182388|Drug|Placebo|
16097408|NCT02182388|Drug|BI 207127 NA powder for solution|
16097409|NCT02182388|Drug|BI 207127 NA tablet|
16097410|NCT02182375|Drug|BI 201335 NA|
16097411|NCT02182375|Drug|Raltegravir|
16097412|NCT02182362|Drug|BI 201335 NA|
16097413|NCT02182362|Drug|Placebo|
16097414|NCT02182349|Drug|BI 201335 NA soft gelatin capsule|
16097415|NCT02182349|Drug|[14C]-BI 201335 NA radiolabelled drug|
16097416|NCT02182336|Drug|BI 201335 NA|"480 mg BI 201335 NA in the morning, 240 mg BI 201335 NA in the evening of day 10
~240 mg BI 201335 NA bid from day 11 to 23"
16097417|NCT02182336|Drug|Caffeine|days 1, 10 and 19
16097418|NCT02182336|Drug|Warfarin sodium|days 1, 10 and 19
16097419|NCT02182336|Drug|Vitamin K|days 1, 10 and 19
16097420|NCT02182336|Drug|Omeprazole|days 1, 10 and 19
16097421|NCT02182336|Drug|Dextromethorphan hydrobromide|days 1, 10 and 19
16097422|NCT02182336|Drug|Midazolam HCl solution|Days 3 and 21
16097423|NCT02182336|Drug|Midazolam HCl oral syrup|days 1, 10 and 19
16097424|NCT02182336|Drug|Digoxin|Days 2 and 20
16097425|NCT02182323|Drug|BI 201335 NA|
16097426|NCT02182323|Drug|Placebo solution|
16097427|NCT02182310|Drug|BI 201335 low dose|
16097428|NCT02182310|Drug|BI 201335 placebo|
16097429|NCT02182310|Drug|Moxifloxacin|
16097430|NCT02182310|Drug|BI 201335 high dose|
16097431|NCT02182297|Drug|BI 201335 NA in single rising doses|
16097432|NCT02182297|Drug|Placebo|
16097433|NCT02182284|Drug|low dose BI 201335 NA soft gelatine capsule (SGC)|
16097434|NCT02182284|Drug|high dose BI 201335 NA soft gelatine capsule (SGC)|
16097435|NCT02182284|Drug|low dose BI 201335 NA powder in bottle (PIB)|
16097436|NCT02182284|Drug|high dose BI 201335 NA powder in bottle (PIB)|
16097437|NCT02182271|Drug|BI 201335 ZW - single rising dose|
16097438|NCT02182271|Drug|Placebo|
16097439|NCT02182258|Drug|BIBF 1120 soft gelatine capsule|
16097440|NCT02182258|Drug|BIBF 1120 intravenous solution|
16097441|NCT02182258|Drug|Placebo ampoule|
16097442|NCT02182245|Drug|BIBF 1120|
16097443|NCT02182245|Drug|Paclitaxel|
16097444|NCT02182245|Drug|Carboplatin|
16097445|NCT02182232|Drug|BIBF 1120|
16097446|NCT02182232|Drug|Paclitaxel|
16097447|NCT02182232|Drug|Carboplatin|
16097448|NCT02182219|Drug|BIBF 1120|
16097449|NCT02182206|Drug|BIBF 1120|
16097450|NCT02182193|Drug|BIBF 1120 capsules charge 1|
16097451|NCT02182193|Drug|BIBF 1120 capsules charge 2|
16097452|NCT02182193|Drug|BIBF 1120 drinking solution|
16097453|NCT02182167|Drug|IV N-acetylcysteine (NAC)|
16097454|NCT02182167|Drug|Water|
16097455|NCT02182154|Drug|BIBF 1120 ES|
16097456|NCT02182141|Drug|BIBF 1120 ES|
16097457|NCT02182128|Drug|BIBF 1120|
16097458|NCT02182115|Drug|antiseptic bundle|"Chlorhexidine gluconate liquid soap for bathing daily.
~Chlorhexidine gluconate mouthrinse to use twice daily.
~Nasal mupirocin to apply twice daily."
16097459|NCT02182115|Drug|standard of care|Surgeon's instructions may include advising patients to use an antiseptic soap prior to surgery.
16097460|NCT02182102|Drug|BIBF 1120|
16097461|NCT02182102|Drug|Pemetrexed|
16097462|NCT02182076|Drug|BIBF 1120|150 mg of BIBF 1120 ES soft gelatine capsules
16097463|NCT02182063|Drug|BIBF 1120 low dose|
16097464|NCT02182063|Drug|BIBF 1120 high dose|
16097465|NCT02182050|Drug|BIBF 1120 ES low dose|
16097466|NCT02182050|Drug|BIBF 1120 ES high dose|
16097467|NCT02182050|Drug|Placebo to BIBF 1120 ES|
16097468|NCT02182037|Drug|Single rising doses of BIBT 1011 BS|
16097469|NCT02182037|Drug|BIBT 1011 BS placebo|
16097470|NCT02182024|Drug|Dabigatran etexilate high dose|
16097471|NCT02182024|Drug|Dabigatran etexilate low dose|
16097472|NCT02182011|Drug|Tenecteplase|
16097473|NCT02182011|Drug|Alteplase|
16097474|NCT02182011|Drug|Streptokinase|
16097475|NCT02181998|Drug|Full dose tenecteplase|
16097476|NCT02181998|Drug|Unfractioned heparin|
16097477|NCT02181998|Drug|Enoxaparin|
16097478|NCT02181985|Drug|Full dose TNK-tPA|
16097479|NCT02181985|Drug|Half dose TNK-tPA|
16097480|NCT02181985|Drug|Heparin|
16097481|NCT02181985|Drug|Enoxaparin|
16097482|NCT02181985|Drug|Abciximab|
16097483|NCT02181972|Drug|Gingko biloba|
16097484|NCT02181972|Drug|Placebo|
16097485|NCT02181959|Drug|Pharmaton® with DMAE|
16097486|NCT02181959|Drug|Pharmaton® without DMAE|
16097487|NCT02181959|Drug|Placebo|
16097488|NCT02181946|Drug|Fluconazole|
16097489|NCT02181946|Drug|Nevirapine|
16097490|NCT02181933|Drug|Nevirapine|
16097491|NCT02181933|Drug|Zidovudine (ZDV)|
16097492|NCT02181933|Drug|Lamivudine (3TC)|
16097493|NCT02181920|Drug|Metamizole|
16097494|NCT02181920|Drug|Diclofenac|
16097495|NCT02181920|Drug|Diclofenac placebo|
16097496|NCT02181920|Drug|Metamizole placebo|
16097497|NCT02181907|Drug|UH-AC 62 XX tablet|
16097498|NCT02181907|Drug|UH-AC 62 XX capsule|
16097499|NCT02181881|Behavioral|DuoPACT|Intervention sessions are administered weekly by a counselor.
16097500|NCT02181881|Behavioral|Life Steps|Intervention sessions are administered weekly by a counselor.
16097501|NCT02181868|Other|Biodegradable and titanium fixation used in mandibular fractures.|
16097502|NCT02181855|Procedure|Full-thickness gastroplication (GERD-X)|Endoscopic full-thickness gastroplication wit the GERD-X device
16097503|NCT02181842|Drug|Pioglitazone|Pioglitazone tablets
16097504|NCT02181829|Radiation|Whole Lung IMRT|External beam radiation therapy will be administered on an outpatient basis, once daily (except weekends and holidays) for approximately two weeks. Patients will undergo a simulation prior to initiation of radiation. Once an IMRT plan is generated which meets all dose constraints specified patients will be treated with 6MV photons for 10 treatments.
16097505|NCT02181816|Drug|Azilsartan/Amlodipine|Azilsartan/Amlodipine combination tablets LD & HD
16097506|NCT02181803|Drug|MK-8189|MK-8189, oral, 2 mg and/or 10 mg tablets, taken QD for a total daily dose of 2 mg, 4 mg, 8 mg, 10 mg, 12 mg, 14 mg, 16 mg, 20 mg, or 40 mg
16097507|NCT02181803|Drug|Placebo|Placebo matching oral 2 mg and/or 10 mg MK-8189 tablets, taken QD
16097508|NCT02181803|Drug|Base Monotherapy|For Part 2 only: participants need to be on monotherapy with an atypical antipsychotic medication (eg, Olanzapine, Quetiapine, Paliperidone, Asenapine, Iloperidone, Aripirprazole, Lurasidone, Risperidone [not to exceed daily dose of 6 mg], or Ziprasidone.) The participant should be on a stable and well tolerated treatment regimen for at least 2 months prior to screening. NOTE: Clozapine is not allowed.
16097509|NCT02181790|Device|Excimer laser|twice weekly treatments with the excimer laser for a total of 8 weeks.
16097510|NCT02181790|Drug|Acitretin|17.5mg/d
16097511|NCT02181777|Behavioral|GRASP|GRoup trAining for Social skills in Psychosis
16097512|NCT02181777|Behavioral|Standard care|Treatment as usual
16097513|NCT02181764|Drug|KRN23|Single SC administration on day 1: 0.3, 0.6 and 1.0 mg/kg
16097514|NCT02181751|Other|Trauma Focused Cognitive Behavioural Therapy Group|Throughout the length of a year children will participate in trauma focused cognitive behavioural group therapy (TF-CBT) with 7 other children in his/her cohort. The group will take place either on site at the Be Brave Ranch, or via skype in their own homes with their parent or caregiver present. In total children will receive over 200 hours of TF-CBT group therapy.
16097515|NCT02181738|Drug|Nivolumab|Specified dose on specified days
16097516|NCT02181738|Drug|Doxorubicin|Specified dose on specified days
16097517|NCT02181738|Drug|Vinblastine|Specified dose on specified days
16097518|NCT02181738|Drug|Dacarbazine|Specified dose on specified days
16097519|NCT02181725|Behavioral|Multimodal Rehabilitation Program|The Multimodal Rehabilitation Program is a Graded exposure based treatment. It consists of a Graded Exposure Module (GE), a Combination Module (HMGE) and a Parent Module (PM).
16097520|NCT02181725|Behavioral|Care as Usual|Care as usual is the care currently provided to adolescents with musculoskeletal chronic pain and is based on the principles of Graded Activity.
16097521|NCT02181712|Biological|Mesenchymal stem cell 0.5|0.5 million MSC per Kg will be infused intravenously. Product will be infused at the rate of 2 - 3 ml/minute during the first 15 minutes and may be adjusted up to 5ml/minutes if tolerable. It is anticipated that the infusion will be completed within approximately 3 hours.
16097522|NCT02181712|Biological|Mesenchymal stem cell 1.0|1 million MSC per Kg will be infused intravenously. Product will be infused at the rate of 2 - 3 ml/minute during the first 15 minutes and may be adjusted up to 5ml/minutes if tolerable. It is anticipated that the infusion will be completed within approximately 3 hours.
16097523|NCT02181699|Drug|KHK2823|single agent KHK2823
16097524|NCT02181673|Drug|Placebo|Participants will receive intravenous infusions of placebo at Weeks 0, 4, 12 and 20 in treatment Group 1 and intravenous infusions of placebo at Week 24 to maintain the blind in treatment Group 2.
16097525|NCT02181673|Drug|Golimumab|Participants will receive intravenous infusions of golimumab 2mg/kg at Weeks 0, 4 and thereafter every 8 weeks up to Week 52 in treatment Group 2 and intravenous infusions of golimumab (2mg/kg) at Weeks 24, 28 and thereafter every 8 weeks up to Week 52 in treatment Group 1.
16097526|NCT02181660|Drug|Gilteritinib|oral
16097527|NCT02181647|Behavioral|Safe Touches: Personal Safety Training for Children|The intervention includes a 50-minute interactive training and an age-appropriate activity book on personal body safety to take home and complete with caregivers. Using culturally appropriate puppets, workshop facilitators use role-play to model scenarios to help children: a) recognize safe and not-safe touches, b) understand body safety, c) practice assertiveness skills, and d) help children identify whom they can go to for help.
16097528|NCT02181634|Drug|Nab-Paclitaxel and Gemcitabine|Nab-Paclitaxel will be administered first, at a dose of 125 mg/m² IV over a period of 30 minutes; gemcitabine will be administered second, at a dose of 1000 mg/m² over a period of 30 minutes.
16097529|NCT02181621|Device|Iodosorb|Cadexomer iodine gel
16097530|NCT02181621|Device|Solosite gel|Hydrogel
16097531|NCT02181595|Other|Group reading and discussion|
16097532|NCT02181582|Drug|Emapunil|Single peroral administration
16097533|NCT02181582|Device|PET|Positron emission tomography, which creates images by detecting radioactivity.
16097534|NCT02181556|Drug|FOLFIRI Protocol|injection of FOLFIRI and Aflibercept every 14 days until progression of disease
16097535|NCT02181556|Drug|Aflibercept Injection|injection of FOLFIRI and Aflibercept every 14 days until progression of disease
16097536|NCT02181543|Drug|Clonidine|1μg/Kg, IV (in the vein) intraoperative. Number of Cycles: single dose.
16097537|NCT02181530|Other|No Intervention|No treatment (intervention) is being administered as part of this study.
16097538|NCT02181517|Drug|abicipar pegol|Abicipar pegol administered to the study eye by intravitreal injection at day 1, weeks 4 and 8.
16097539|NCT02181517|Drug|ranibizumab|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
16097540|NCT02181517|Other|sham procedure|Sham procedure to the study eye at weeks 12 and 16.
16097541|NCT02181504|Drug|abicipar pegol|Abicipar pegol administered to the study eye by intravitreal injection at day 1, weeks 4 and 8.
16097542|NCT02181504|Drug|ranibizumab|Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
16097543|NCT02181504|Other|sham procedure|Sham procedure to the study eye at weeks 12 and 16.
16097544|NCT02181491|Other|[11C]-P943|
16097545|NCT02181478|Drug|cyclophosphamide|All patients will receive a single IV dose of 50 mg/kg of cyclophosphamide on day -6
16097546|NCT02181478|Drug|fludarabine phosphate|Given by IV during prep at 40mg/m2 for 5 days
16097547|NCT02181478|Radiation|total-body irradiation|Undergo single fraction of reduced intensity conditioning (RIC) regimen of 200 cGy TBI without shielding on day -1
16097548|NCT02181478|Drug|cyclosporine|Initiated in patients on the day -5. Cyclosporine will be administered orally or intravenously at 2 mg/kg/dose every 12 hours for 2-hour period. Cyclosporine will continue until day +100
16097549|NCT02181478|Drug|mycophenolate mofetil|Given at 1g intravenously or orally twice daily from day -5 to +100, or as clinically indicated.
16097550|NCT02181478|Procedure|umbilical cord blood transplantation|Following RIC, on day T+0, dimethylsulphoxide will be removed from the cord blood cells and given as transplant.
16097551|NCT02181478|Procedure|mesenchymal stem cell transplantation|The total dosage of hMSC will be 2x10^6cells/kg (+/-20%).
16097552|NCT02181465|Biological|G17DT|
16097553|NCT02181439|Device|(LLLT Low Level Laser Therapy) SiroLaser advance|Irradiation scanning distance of the mucosa over an area ranging from the mesial surface of the maxillary canine to the distal surface of the maxillary first molar in the sagittal direction, and the CEJ to the bottom of the vestibule in the vertical direction.
16097554|NCT02181426|Drug|Ketorolac Dose|Subjects will be assigned an enrollment number. Enrollment numbers will be assigned consecutively in the order of study enrollment. Based on the enrollment number, subjects will be randomized by a pre-determined computer randomization list created by a statistician to receive a ketorolac dose (0, 7.5, 15, 30 mg).
16097555|NCT02181413|Drug|Ixazomib Citrate|Ixazomib citrate capsules
16097556|NCT02181413|Drug|Placebo|Ixazomib citrate placebo-matching capsules
16097557|NCT02181400|Device|Ellex Integre NIR laser|"Each NIR light treatment will consist of a 90 second exposure of the macula of the study eye to the Ellex Integre NIR laser with the patient fixating on the central aiming beam. The laser light beam is 4.5mm in diameter with a central masked area of 1.0 mm diameter containing the central fixation target. In this way the central macula will be spared in the event of an adverse effect of the laser, which we do not anticipate.
~The patient will be seated at the slit lamp laser delivery system and after the eye has been dilated and anesthetised with topical eye drops a standard fundus contact lens will be placed on the eye through which the post area pole will be visualised while the treatment is delivered. There will be 12 treatments administered over a 5 week period."
16097558|NCT02181387|Drug|Acetaminophen|administered every 6 hours by mouth up to 4 doses
16097559|NCT02181387|Drug|Placebo|
16097560|NCT02181361|Drug|hirudin plus aspirin|natural hirudin 0.75g, three times a day (Brand name: Maixuekang capsule, Guizhou Xinbang Pharmaceutical Co., China) and aspirin 100mg, once daily
16097561|NCT02181361|Drug|Warfarin|an initial dose of 1.25mg once daily. Three days later, INR of patients was checked every three days and the dose of warfarin was adjusted until reach the target range of 2 to 3. Since then INR monitoring was performed at 1, 2, 3, 6, 9, 12 months after stroke onset, targeting an INR between 2 and 3 and the dose of warfarin was adjusted accordingly.
16097562|NCT02181348|Drug|Vitamin E|dl-alpha tocopheryl acetate 400 mg once daily for 3 months
16097563|NCT02181348|Drug|placebo (edible oil)|
16097564|NCT02181335|Drug|Respimat® Budesonide low dose|
16097565|NCT02181335|Drug|Respimat® Budesonide high dose|
16097566|NCT02181335|Drug|Turbohaler® Budesonide|
16097567|NCT02181335|Drug|Placebo|
16097568|NCT02181322|Drug|Meloxicam - low dose|
16097569|NCT02181322|Drug|Meloxicam - medium dose|
16097570|NCT02181322|Drug|Meloxicam - high dose|
16097571|NCT02181309|Drug|Meloxicam, low dose|
16097572|NCT02181309|Drug|Meloxicam, medium dose|
16097573|NCT02181309|Drug|Meloxicam, high dose|
16097574|NCT02181296|Drug|ropivacaine|
16097575|NCT02181283|Behavioral|W+W|"Web-delivered brief intervention: Participants receive a 30-40 minute Web-based intervention which includes a tailored review of participants' goals/values, feedback regarding their present alcohol/prescribed opioid/sedative use patterns and consequences, developing a discrepancy between their alcohol or prescribed drug use, ability to meet goals and values through a decisional balance exercise, and formulation of a tailored change plan.
~Web booster sessions: Web boosters will be completed at 1, 2 and 3 months post-BI. Content is tailored to the individual based on answers to baseline questions and responses during Web-based BI. Web-based Booster will: 1) briefly ascertain current AOS use, 2) changes in AOS since completing Web BI, 3) progress toward goals, and 4) plans and encouragement for next steps."
16097576|NCT02181283|Behavioral|W+P|"Web-delivered brief intervention: Participants receive a 30-40 minute Web-based intervention which includes a tailored review of participants' goals/values, feedback regarding their present alcohol/prescribed opioid/sedative use patterns and consequences, developing a discrepancy between their alcohol or prescribed drug use, ability to meet goals and values through a decisional balance exercise, and formulation of a tailored change plan.
~Peer booster sessions: The peer supporter will work with participants at 1, 2, and 3 months post-Web-based BI. Peer supports will address Service Members' own goals and will provide emotional and informational support."
16097577|NCT02181270|Other|high intensity exercise|Subjects will perform 5-10 minute warm-up (50% VO2peak). Subjects will then exercise at an exercise intensity that corresponds to 90% HRmax, for 4 minutes. This will be followed by 3 min of exercise at 55% HRmax. Four of these exercise intervals/recovery periods will be completed. The total exercise commitment will be ~45 minutes
16097578|NCT02181270|Other|continuous moderate exercise|Subjects will perform a 5-10 minute warm-up at 50% VO2peak. Thereafter, the intensity of exercise will be increased to 70% VO2peak by increasing the speed and incline of the treadmill. Subjects will exercise at this intensity for 60 minutes.
16097579|NCT02181257|Combination Product|Extracorporeal Photopheresis (ECP)|"Procedure:
~ECP treatments will be performed using one of two Therakos systems. Both systems use the drug Methoxsalen"
16097580|NCT02181244|Other|Egg, one a day, for breakfast|One egg per day as breakfast for 5 weeks followed by a 3 week washout period and 5 additional weeks on oatmeal. This is a randomized crossover design. Half of subjects started with the eggs and the other half with oatmeal. Blood lipids, glucose and inflammatory measurements will be finished 24. weeks after completion of the study. Data will be reported 1 year after the completion of the study.
16097581|NCT02181244|Other|Oatmeal, one cup a day|Subjects will be fed oatmeal for a period of 5 weeks. After 3 weeks they will be switched to the alternate diet. This is a randomized control trail in which plasma glucose, plasma lipids and inflammatory markers will be measured. All these measurements will be finished 24 weeks after completion of the study. Data will be reported after 1 year of the completion of the study.
16097688|NCT02180503|Drug|BI 1356 BS tablet - low dose|
16097582|NCT02181231|Drug|venlafaxine XR|slow titration up to maximum dose of 300mg per day, will remain on venlafaxine XR for up to 32 weeks
16097583|NCT02181231|Drug|buprenorphine|randomized to either buprenorphine or placebo, dose range from 0.2 mg/ qd to 2mg/ qd
16097584|NCT02181231|Drug|Placebo|patients will remain on venlafaxine XR and be randomized to receive either placebo or buprenorphine for 8 weeks. at the end of the 8 weeks those who did not receive buprenorphine will be offered the opportunity to try it.
16097585|NCT02181218|Drug|Romidepsin|
16097586|NCT02181218|Drug|Gemcitabine|
16097587|NCT02181218|Drug|Oxaliplatin|
16097588|NCT02181218|Drug|Dexamethasone|
16097589|NCT02181218|Drug|Pegfilgrastim|
16097590|NCT02181205|Drug|bupivacaine|
16097591|NCT02181205|Drug|placebo|
16097592|NCT02181192|Device|PET/CT|PET/CT
16097593|NCT02181192|Radiation|Instant Radiotherapy according to guidelines|Instant Radiotherapy according to guidelines
16097594|NCT02181192|Radiation|Radiotherapy after achievement of PSA marginal value|Radiotherapy after achievement of PSA marginal value
16097595|NCT02181179|Behavioral|Yoga|The yoga intervention will be an 8-week program involving two 60-minute sessions each week at a local studio with three locations in Austin. Participants will be instructed to take classes deemed within a moderate-to-vigorous intensity dose. Participants will also be encouraged both by the PI and yoga instructors to complete the entire 60 minutes of yoga, urged to do only what is comfortable and not push themselves beyond their physical limits.
16097596|NCT02181166|Other|Kinesiotherapy|
16097597|NCT02181166|Other|Isquemic compression|
16097598|NCT02181166|Other|High voltage electrical stimulation|
16097599|NCT02181153|Other|sample blood and fecal collection|Blood and fecal samples will be collected at the day of enrolment
16097600|NCT02181140|Device|EUS guided FNA and fine needle punction|punction of a suspect area by a EUS guided fine needle as well as pro core fine needle to evacuate histology and smear biologics
16097601|NCT02181127|Device|Glucagon-only Bionic Pancreas|A computer algorithm will automatically deliver glucagon based on the signal from a minimally invasive continuous glucose monitor.
16097602|NCT02181114|Behavioral|Expert System Coaching|Patients will receive coaching and feedback over the phone and stag-appropriate educational materials (i.e. paphlets, brochures, personalized feedback report) based on their answers to the survey questions and where they are in their kidney transplant evaluation process.
16097603|NCT02181101|Drug|FEC-DocGemzar adjuvant chemotherapy|
16097604|NCT02181101|Drug|FEC-Doc adjuvant chemotherapy|
16097605|NCT02181101|Drug|Zoledronic acid i.v. 2 years|
16097606|NCT02181101|Drug|Zoledronic acid i.v. 5 years|
16097607|NCT02181088|Biological|ChAd63 RH5 low dose|ChAd63 RH5 at 5 x 10^9 vp
16097608|NCT02181088|Biological|ChAd63 RH5 full dose|ChAd63 RH5 at 5 x 10^10 vp
16097609|NCT02181088|Biological|MVA RH5 low dose|MVA RH5 at 1 x 10^8 pfu
16097610|NCT02181088|Biological|MVA RH5 full dose|MVA RH5 at 2 x 10^8 pfu
16097611|NCT02181075|Drug|ThermoDox® (LTLD)|ThermoDox® (LTLD) infusion at a dose of 50mg/m2 whilst under general anaesthetic during intervention (Day 1)
16097612|NCT02181075|Device|Focused Ultrasound of Target Liver Tumour|Whilst the ThermoDox® was circulating in the blood stream, the JC200 Therapeutic Ultrasound device was used to induce mild hyperthermia in a single (region of) a target liver tumour.
16097613|NCT02181075|Diagnostic Test|Pre-LTLD Biopsy of Target Liver Tumour|
16097614|NCT02181075|Diagnostic Test|Post-LTLD Biopsy of Target Liver Tumour|
16097615|NCT02181075|Diagnostic Test|Post-LTLD+FUS (Post-FUS) Biopsy of Target Liver Tumour|
16097616|NCT02181075|Device|Thermometry of Target Tumour|A clinically approved thermistor or thermocouple was placed in the target liver tumour for real-time thermometry.
16097617|NCT02181062|Behavioral|Walking Intervention|"4-week series of twice-weekly 1-hour group-based case-manager-led interactive sessions.
~The intervention will provide the knowledge necessary to improve stroke risk factors. Case manager group leaders will teach that seeing a healthcare provider regularly and monitoring blood pressure prevents strokes; all participants will be provided with the National Institute on Aging booklet, How to Talk to your Doctor and the contact information for their healthcare provider.
~Participants will be given a pedometer and be trained to use it to measure steps, with the goal of reaching 10,000 steps each day.
~The intervention will utilize attribution retraining to teach seniors that stroke risk factors including sedentary lifestyle should not be attributed to old age."
16097618|NCT02181036|Other|family work shop|2-3 hours per session, one session per week, a total of 6 weeks of family work shop
16097619|NCT02181023|Drug|Aclidinium Bromide|Aclidinium Bromide 322 mcg inhalation powder via Genuair inhaler (Eklira) Product by Almirall, S.A. Ronda General Mitre, 151. ES-08022 Barcelona, Spain
16097620|NCT02181023|Drug|Glycopyrronium Bromide|Glycopyrronium Bromide 44 mcg dry powder (capsules) inhaled via Breezehaler inhaler, Seebri - product by Novartis Europharm Limited - Wimblehurst Road, Horsham, West Sussex, RH12 5AB; United Kingdom
16097621|NCT02181010|Behavioral|Intervention|Intervention components will occur at the policy level (working within Baltimore City policy makers to sustain intervention components, and develop virtual simulations of the Baltimore food environment); food wholesaler level (working with wholesalers to stock healthier food items and provide pricing incentives to storeowners on healthier foods); small food retail outlet level (working with corner store and carry-out owners to stock, promote, and sell healthier foods and beverages); neighborhood level (working with Baltimore college students to deliver nutrition intervention sessions to younger youth in recreation centers in intervention neighborhoods); household level (providing a text messaging and social media program that provides parents and caregivers tips for healthier eating in their respective neighborhoods).
16097622|NCT02180997|Drug|Tamsulosin|Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily
16097623|NCT02180997|Drug|Solifenacin|Tamsulosin and solifenacin: Solifenacin 10 mg, once daily
16097624|NCT02180997|Drug|Tamsulosin and solifenacin|Tamsulosin and solifenacin: Tamsulosin 0.4mg, once daily, Solifenacin 10 mg, once daily
16097689|NCT02180503|Drug|BI 1356 BS PIB - high dose|
16097690|NCT02180503|Drug|BI 1356 BS tablet - high dose|
16097691|NCT02180503|Drug|BI 1356 BS tablet - high dose with food|
16097692|NCT02180490|Drug|UHAC 62 XX tablet|
16097693|NCT02180490|Drug|UHAC 62 XX capsule|
16097625|NCT02180984|Device|TMS|Transcranial Magnetic Stimulation has developed into a powerful tool that utilizes magnetic fluxes to non-invasively stimulate the human cortex. The technique involves placement of a small coil over the scalp; passing a rapidly alternating current through the coil wire, which produces a magnetic field that passes unimpeded through the scalp and bone, resulting in electrical stimulation of the cortex.
16097626|NCT02180971|Procedure|Positive CAG with EG test|A positive finding for coronary angiography with an ergonovine provocation test is defined as transient, total, or sub-total occlusion (>90% stenosis) with signs/symptoms of myocardial ischemia (chest pain and ischemic ECG change).
16097627|NCT02180971|Procedure|Negative CAG with EG test|Negative test: less than 70% luminal narrowing, without chest pain or ST-segment changes after ergonovine coronary injection
16097628|NCT02180932|Biological|periodontal pocket samples|
16097629|NCT02180919|Device|CE marked Philips Motiva system|Telemonitoring will be carried out in the patient's home using the CE marked Philips Motiva system which comprises weight scales, blood pressure and heart rate monitoring, finger pulse oximeter and provides question/answer prompts all of which is linked to the patient's television screen and can be tuned into just as like a TV channel. Measurements of blood pressure, heart rate and weight will be obtained from the heart failure patients daily. In the respiratory patients heart rate and oximetry will be measured daily, and blood pressure and weight once a week.
16097630|NCT02180893|Other|Paravertebral Block|Paravertebral nerve block injection
16097631|NCT02180893|Other|Placebo Comparator|"No block
~Patients who did not receive PVB"
16097632|NCT02180880|Drug|Pregabalin and Oxcarbazepine|"Subjects will take pregabalin for the duration of 2 weeks. The dosage will be increased from 75 mg twice to 150 mg twice a day.
~Subjects will stop pregabalin for 1 week and take oxcarbazepine 150mg twice."
16097633|NCT02180867|Drug|Doxorubicin|Given IV
16097634|NCT02180867|Drug|Doxorubicin Hydrochloride|Given IV
16097635|NCT02180867|Drug|Ifosfamide|Given IV
16097636|NCT02180867|Drug|Pazopanib|Given PO
16097637|NCT02180867|Drug|Pazopanib Hydrochloride|Given PO
16097638|NCT02180867|Radiation|Radiation Therapy|Undergo radiation therapy
16097639|NCT02180867|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16097640|NCT02180854|Other|Control group|
16097641|NCT02180854|Other|Increased monitoring frequency|
16097642|NCT02180841|Dietary Supplement|Soy Protein Powder (25g/d)|Participants will consume 25g soy protein powder daily for a 6 week treatment period.
16097643|NCT02180841|Dietary Supplement|Placebo|Participants will consume a placebo control powder containing 0g soy protein powder daily for a 6 week treatment period.
16097644|NCT02180841|Dietary Supplement|Soy Protein Powder (50g/d)|Participants will consume 50g soy protein powder daily for a 6 week treatment period.
16097645|NCT02180828|Drug|Clotrimazole vaginal tablet|2 doses of 500 mg Clotrimazole administered intravaginally (at day1 and day4)
16097646|NCT02180828|Drug|Fluconazole|2 doses of 150 mg oral Fluconazole (at day1 and day4)
16097647|NCT02180815|Device|ReVENT Sleep Apnea System|
16097648|NCT02180802|Behavioral|motivational interviewing|
16097649|NCT02180802|Behavioral|motivational interviewing with parental involvement|
16097650|NCT02180802|Behavioral|Control group|
16097651|NCT02180789|Drug|Tamsulosin OCAS|oral
16097652|NCT02180776|Other|Summit 456 TLSO|Thoracolumbarsacral orthosis
16097653|NCT02180763|Biological|Gammanorm|Sub-Q IgG
16097654|NCT02180750|Other|Memory Work Therapy|
16097655|NCT02180750|Other|Standard care|Pediatric clinic, ART
16097656|NCT02180737|Drug|Dexmeditomedine|
16097657|NCT02180724|Drug|Acalabrutinib (ACP-196)|
16097658|NCT02180711|Drug|acalabrutinib|
16097659|NCT02180711|Drug|rituximab (IV)|
16097660|NCT02180711|Drug|Lenalidomide|
16097661|NCT02180698|Other|Laboratory Biomarker Analysis|Correlative studies
16097662|NCT02180698|Radiation|Radiation Therapy|Undergo radiation therapy
16097663|NCT02180698|Drug|TLR4 Agonist GLA-SE|Given intratumorally
16097664|NCT02180685|Other|Anchor fixation|
16097665|NCT02180672|Drug|Nasal Fluticasone|One spray per nostril, per day.
16097666|NCT02180672|Drug|Placebo|One spray per nostril, per day.
16097667|NCT02180659|Drug|sublingual buprenorphine tablets|
16097668|NCT02180659|Drug|Buprenorphine implant|
16097669|NCT02180659|Drug|placebo implants|
16097670|NCT02180659|Drug|sublingual placebo tablets|
16097671|NCT02180646|Other|High protein breakfast|a high protein breakfast - 500 kcal (35% protein, 45% CHO, 20% fat)
16097672|NCT02180646|Other|High carb breakfast|a high carbohydrate breakfast - 500 kcal (15% protein, 65% CHO, 20% fat)
16097673|NCT02180633|Other|Optical Coherence Tomography Scan|As an observational study, the only interventive action taken is the acquisition of a non-invasive volumetric image of the retina via optical coherence tomography (OCT).
16097674|NCT02180620|Other|No exercise|During the no exercise trial (NoEX), the participants will remain sedentary during testing.
16097675|NCT02180620|Other|Meal then exercise|During the post-meal exercise trial (M→EX), 45 min of resistance training will be performed
16097676|NCT02180620|Other|exercise then meal|During the exercise prior to the meal trial (EX→M), 45 min of resistance training will be performed
16097677|NCT02180581|Dietary Supplement|Probiotic (2 * 10^9 cfu/day)|Combination of two probiotics (2 * 10^9 cfu/day) or probiotics for 6 months
16097678|NCT02180581|Dietary Supplement|Placebo|Placebo for 6 months
16097679|NCT02180568|Procedure|Lipiodol|Lipiodol-guided lung localization technique
16097680|NCT02180568|Procedure|Hookwire|Hookwire-guided lung localization technique
16097681|NCT02180568|Drug|Lipiodol|
16097682|NCT02180555|Other|Oral glucose tolerance test|
16097683|NCT02180529|Drug|Methylphenidate|On the intervention days (days 2-4) participants will undergo cognitive assessment at 9:00 in the morning, followed by the administration (at 10:30) of different doses of Ritalin (10, 20 and 30mg) every day of intervention.
16097684|NCT02180529|Drug|Placebo|
16097685|NCT02180516|Drug|Meloxicam|
16097686|NCT02180516|Drug|Other Non Steroidal Anti-Inflammatory Drugs (NSAIDs) except etodolac|
16097687|NCT02180503|Drug|BI 1356 BS PIB - low dose|
16097694|NCT02180477|Drug|UHAC 62 XX - TF1 tablet|
16097695|NCT02180477|Drug|UHAC 62 XX - TF2 tablet|
16097696|NCT02180477|Drug|UHAC 62 XX - capsules|
16097697|NCT02180464|Drug|LAS41004|
16097698|NCT02180464|Drug|control|
16097699|NCT02180438|Drug|Stribild (Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF) 1 tablet daily X 48 weeks|
16097700|NCT02180425|Drug|Tretinoin or Adapalene|Subjects will apply a pea sized amount of topical retinoid cream once daily at night for 30 days. Subjects will return for a follow-up visit.
16097701|NCT02180425|Drug|Isotretinoin|Subjects will take one pill once daily for 5 months. Subjects will return after 1 month and after 4-5 months of treatment for skin lipid profiling.
16097702|NCT02180412|Biological|Panhematin|Glucose loading
16097703|NCT02180412|Other|Glucose|Glucose is administered to both groups as routine care.
16097704|NCT02180386|Behavioral|Patients will play a video game with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit.|videogame can be considered as a method of distraction.
16097705|NCT02180360|Other|Capoeira training group|"Capoeira training: The experimental Capoeira training protocol, based in the modern styles of Capoeira was applied by an instructor with 17 years of experience in teaching Capoeira, followed the directions of the Basic Programmed Lesson, created by Geraldo Pereira d'Santana (Master Santana) in a Capoeira group called IUNA from the city of São Paulo, Brazil.
~In order to perform the Basic Programmed Lesson program, the activities were divided in four stages, being composed of the main movement that characterizes Capoeira (the ginga) and by other movements such as: dodging, unbalancing, traumatizing and acrobatic.
~An important thing to highlight in the experimental protocol is that the training performed in the present study used only specific movements of Capoeira, without applying any other traditional stretching exercises. Therefore, it is possible to infer that the results obtained are due to the experimental protocol."
16097706|NCT02180347|Device|Contact lenses|
16097707|NCT02180334|Drug|Mosapride citrate|On the day of MMTT, 1 tablet (5 mg) of mosapride will be administered orally to participants of 'mosapride' arm. After 1 hour, MMTT will be performed.
16097708|NCT02180334|Drug|Linagliptin|During run-in period, 1 tablet (5mg) per day will provided for 7 days. On the day of MMTT, 1 tablet (5 mg) of linagliptin will be administered orally to participants of both arms. After 1 hour, MMTT will be performed.
16097709|NCT02180334|Drug|Acetaminophen (paracetamol)|On the day of MMTT, 3 tablets (1500 mg) of acetaminophen (paracetamol) will be administered orally to participants of both arms at the start of MMTT with manufactured mixed meal (0 min).
16097710|NCT02180321|Drug|Tranexamic Acid|10mg/kg of tranexamic acid loading infusion for 15 min from beginning of the surgery, then continuous infusion throughout the surgery for 5mg/kg/hr
16097711|NCT02180321|Drug|normal saline|10mg/kg of normal saline loading infusion for 15 min from beginning of the surgery, then continuous infusion throughout the surgery for 5mg/kg/hr
16097712|NCT02180308|Device|PET/MRI|Simultaneous PET/MRI (3T system)
16097713|NCT02180295|Biological|V212 Lot 1|Inactivated Varicella Zoster Virus vaccine
16097714|NCT02180295|Biological|V212 Lot 2|Inactivated Varicella Zoster Virus vaccine
16097715|NCT02180295|Biological|V212 Lot 3|Inactivated Varicella Zoster Virus vaccine
16097716|NCT02180282|Device|M22-IPL|"The M22 is an advanced computer-controlled light emission system that incorporates several different light modules.
~The IPL hand piece operates at a spectrum of 400-1200nm with 7 different filters that can be easily inserted to the hand piece to treat different conditions. The IPL hand piece also includes 2 different sapphire cooled light guides of 8x15mm and 15x35mm. The cut-off filter that will be used for this evaluation is the Acne Filter that cuts off all light with the wavelength of 400-600 and 800-1200nm."
16097717|NCT02180269|Drug|JNJ-54861911 (25 mg)|Single oral dose of JNJ-54861911, 25 mg on Day 1.
16097718|NCT02180269|Drug|JNJ-54861911 (50 mg)|Single oral dose of JNJ-54861911, 50 mg on Day 1.
16097719|NCT02180269|Drug|JNJ-54861911 (100 mg)|Single oral dose of JNJ-54861911, 100 mg on Day 1.
16097720|NCT02180269|Drug|Placebo|Single oral dose of placebo matched to JNJ-54861911 on Day 1.
16097721|NCT02180256|Procedure|Endometrial Scratching|The intentional damage to the endometrium performed with the objective of improving the reproductive outcomes of women desiring pregnancy.
16097722|NCT02180243|Behavioral|Yoga/Acupuncture|Individuals randomized to this group will participate in iRest Yoga Nidra and auricular acupuncture.
16097723|NCT02180243|Other|Gulf War Health Education|Participants randomized to this group will take part in a health education group.
16097724|NCT02180230|Device|Shorty implants|Dental implant insertion to maxilla or mandible
16097725|NCT02180217|Drug|osilodrostat|Osilodrostat comes in the form of film-coated tablets for oral administration, in the following strengths: 1 mg, 5 mg, 10 mg, and 20 mg. The maximum dose of osilodrostat was 30 mg bid.
16097726|NCT02180217|Drug|LCI699 matching placebo|Osilodrostat placebo comes in the form of film-coated tablets for oral administration, in the following strengths: 1 mg, 5 mg, 10 mg, and 20 mg. The maximum dose of osilodrostat placebo was 30 mg bid.
16097727|NCT02180204|Drug|Tenecteplase|Tenecteplase 0.25 mg/kg IV - Maximum 25 mg
16097728|NCT02180204|Drug|Alteplase|Alteplase 0.9 mg/kg IV - Maximum: 90 mg
16097729|NCT02180191|Other|Comparison of the gut microbiota composition|
16097730|NCT02180178|Other|observational only- no intervention|
16097731|NCT02180165|Drug|Posaconazole|300 mg posaconazole twice on Day 1, either by oral tablet or IV solution; followed by 300 mg once daily for up to 84 days
16097732|NCT02180165|Drug|Voriconazole|300 mg voriconazole oral tablet (or 6 mg/kg IV solution) twice on Day 1, followed by 200 mg oral tablet (or 4 mg/kg IV solution) twice daily for up to 84 days
16097733|NCT02180152|Behavioral|Postprandial walks|Obese pregnant women will be target to carry out walks lasting 10' after the main meals (breakfast, lunch and dinner), Monday to Friday, during 8 weeks. Adherence to the program will be determined by daily readings of pedometers previously provided to pregnant women; minimum of 1500 steps per day from Monday to Friday.
16097734|NCT02180139|Device|transcranial direct current stimulation|tDCS using a constant current of 2 mA via two 35 cm2 saline soaked sponge electrodes. Treatment is 1x/day for 4 days.
16097735|NCT02180126|Other|Follow-up|Follow-up of of patients with borderline positive ANCA test results
16097858|NCT02179177|Drug|Apixaban|Drug is taken by mouth twice a day for 6 months
16097736|NCT02180113|Device|Fibroscan® examination|Each patient undergo 1 LSM and at least 1 SSM (2 in more if the patient accept to participate at the ancillary study (intra and inter operator reproducibility of SSM).
16097737|NCT02180100|Drug|Terconazole Vaginal Suppository|Terconazole Vaginal Suppository inserted intravaginally once daily before bedtime for 6 consecutive days
16097738|NCT02180100|Drug|Fluconazole|orally Fluconazole 150 mg (Pfizer Pharmaceuticals) at day 1 and day 4.
16097739|NCT02180087|Drug|Ketoprofen|
16097740|NCT02180061|Biological|Pembrolizumab|IV infusion
16097741|NCT02180048|Dietary Supplement|400 mg of caffeine/day (Two 200mg pills/day)|One phase of treatment will have participants consume two 200 mg-caffeine pills day (total of 400 mg of caffeine/ d) for 7 days.
16097742|NCT02180048|Dietary Supplement|200 mg of caffeine/day (One 200mg pill and one placebo pill)|This arm will receive one 200 mg caffeine pill and one sugar pill (placebo pill)
16097743|NCT02180048|Dietary Supplement|Two placebo pills/day|This arm will have participants consume two placebo pills each day.
16097744|NCT02180035|Dietary Supplement|Symbiotic|6g sachet composition: Lactobacillus paracasei, Lactobacillus rhamnosus, Lactobacillus acidophillus, Bifidobacterium lactis and fructooligosaccharides. Each patient was instructed to consume two sachets per day, one in the morning and another before bedtime, diluted in 100 ml of filtered or boiled water at room temperature. The dietary supplement should be taken every day for 6 months.
16097745|NCT02180035|Dietary Supplement|Maltodextrin (placebo for symbiotic)|6g sachet of maltodextrin, a complex carbohydrate. Each patient was instructed to consume two sachets per day, one in the morning and another before bedtime, diluted in 100 ml of filtered or boiled water at room temperature. Placebo should be taken daily for 6 months.
16097746|NCT02180035|Behavioral|Nutritional intervention|Nutritional intervention consists of dietary prescription (nutritional eating plan) for healthy eating based on the Dietary Guidelines for the Brazilian Population and Clinical Manual on Food and Nutrition in HIV-infected Adults Care, both Brazil Ministry of Health guidelines, in addition to nutritional counseling for preexistent clinical conditions.
16097747|NCT02180022|Drug|Placebo|After randomization, placebo was treated for 12 weeks
16097748|NCT02180022|Drug|Onion peel extract|After randomization, onion peel extract was treated for 12 weeks
16097749|NCT02179996|Biological|Three vaccine injections DTP-pertussis-Hib|DTP-pertussis-Hib injections at two, three, four months after birth
16097750|NCT02179996|Biological|Two vaccine injections DTP-pertussis-Hib|DTP-pertussis-Hib injections are administered at two and four months after birth
16097751|NCT02179983|Procedure|Pulmonary rehabilitation|6 weeks of supervised exercise and education (pulmonary rehabilitation)
16097752|NCT02179983|Procedure|Pulmonary rehabilitation|6 weeks of exercise and patient education following exacerbation (pulmonary rehabilitation)
16097753|NCT02179970|Drug|Plerixafor|A continuous 7 day intravenous infusion, starting at a dose of 20 ug/kg/hr, and subsequent dose levels of 40, 80 and 120 ug/kg/hr.
16097754|NCT02179931|Drug|Flupentixol/melitracen film-coated tablet|
16097755|NCT02179931|Drug|Flupentixol/melitracen coated tablet (Deanxit®)|
16097756|NCT02179918|Drug|PF-05082566|Starting dose of 0.45 mg/kg q3wks IV, dose escalation
16097757|NCT02179918|Drug|MK-3475|2 mg/kg q3wks, IV
16097758|NCT02179892|Drug|Bupivacaine Extended-Release Liposome Injection (Exparel)|266mg/30mL of Exparel will be injected via unilateral TAP block
16097759|NCT02179892|Drug|Bupivacaine and Dexamethasone Injection|As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone will be injected via unilateral TAP block.
16097760|NCT02179892|Drug|IV Acetaminophen|Intravenous (IV) acetaminophen 1000 mg every 8 hours for 8 doses.
16097761|NCT02179892|Drug|Oral Acetaminophen|Oral acetaminophen 650 mg every 6 hours.
16097762|NCT02179879|Other|Video validation|Video taping of anaesthetist (experts and novices) perfoming labor epidural.
16097763|NCT02179866|Drug|RO5285119|Single oral dose of RO5285119 with approximately 2.1 MBq (56.6 uCi) [14C]-radiolabeled RO5285119 administered as a drinking solution under fasted conditions on Day -1
16097764|NCT02179853|Drug|Anakinra|First two doses IV followed by SQ dosing
16097765|NCT02179840|Procedure|Mechanical ventilation adjustment|Mechanical ventilation adjustment and study procedure: This is a validation study of the CHS method in assessing cerebral microvascular hemodynamic changes. Cyclical physiological events such as respiration are essential in CHS methodology. The previous study shows that the robust measurement of the CHS method occurs at a respiratory rate of about 4-10 breaths per minute. Therefore, we propose the following respiration adjustment in this study with the consideration that CO2 is a powerful regulator of cerebral blood flow. Blood gas analysis will be performed during the 1st and 2nd rounds of ventilation adjustment.
16097766|NCT02179814|Drug|AMPT/ Demser|alpha-methyl-paratyrosine (AMPT, trade name: Demser) body-weight adjusted dosage (40 mg/kg body weight, maximum 4000mg) at 4 medication intake time points over 24 hours
16097767|NCT02179814|Drug|Diphenhydramine|Diphenhydramine (25mg) at the first medication intake time point
16097768|NCT02179814|Drug|Placebo|Placebo at the second, third and fourth medication intake time point
16097769|NCT02179788|Behavioral|Standard care|Mothers will be instructed to thoroughly empty their breasts at least 8 times per 24 hours by breastfeeding, followed by breast expression with a combination of hand -expression and the use of a hospital-grade electric breast pump (provided by study).
16097770|NCT02179788|Drug|Metformin|"The metformin arm will be consuming Glucophage XR (metformin hydrochloride extended release, 750 or 500 mg, encapsulated in #00 opaque capsules for 4 weeks according to the following schedule:
~Days 1-7, take one 750 mg capsule with evening meal (750 mg/day)
~Days 8-14, take three 500 mg capsule with evening meal (1500 mg/day)
~Days 14-28 (or through completion of post-intervention data collection), take four 500 mg capsules with evening meal (2000 mg/day)
~Actual increase in dose may occur more slowly if standard titration schedule is not well tolerated. Adjustments to schedule will be made in consultation with the adult medicine study co-investigator.
~The trial duration is 28 days (with a +/- 3 day cushion)"
16097816|NCT02179515|Biological|MVA-brachyury- TRICOM|It is an active cancer immunotherapy administered via subcutaneous injection.
16097817|NCT02179502|Drug|GLPG1690 single ascending doses|Single dose, oral suspension or solid formulation, starting dose of 20mg escalating up to 1500mg
16097818|NCT02179502|Drug|Placebo single ascending doses|Single dose, oral suspension or solid formulation matching placebo
16097859|NCT02179177|Drug|Placebo|
16097771|NCT02179788|Drug|Placebo|"The placebo arm will be consuming methylcellulose USP Powder encapsulated in #00 opaque capsules (supplied by PCCA, Houston TX) for 4 weeks according to the following schedule:
~Days 1-7, take 1 capsule with evening meal
~Days 8-14, take 3 capsules with evening meal
~Days 14-28 (or through completion of post-intervention data collection), take four capsules with evening meal
~Actual increase in dose may occur more slowly if standard titration schedule is not well tolerated. Adjustments to schedule will be made in consultation with the adult medicine study co-investigator."
16097772|NCT02179775|Drug|propranolol|
16097773|NCT02179775|Drug|Quince's oxymel|
16097774|NCT02179775|Drug|placebo|
16097775|NCT02179762|Behavioral|moderate exercise intervention|Perform moderate exercise therapy
16097776|NCT02179762|Behavioral|vigorous exercise intervention - standard|Perform HIIT exercise therapy on a standard stationary bike
16097777|NCT02179762|Other|questionnaire administration|Ancillary studies: Functional Assessment of Cancer Therapy-General (FACT-G), Godin Leisure-Time Exercise questionnaire, 24-hour diet recalls, USDA 5 Step Multiple Pass Method, Memorial Anxiety Scale for Prostate Cancer, Pittsburgh Sleep Quality Index (PSQI)
16097778|NCT02179762|Other|laboratory biomarker analysis|Correlative studies
16097779|NCT02179762|Behavioral|vigorous exercise intervention - cybercycling|perform HIIT exercise on cybercycles aided by electronic racing and other games
16097780|NCT02179762|Behavioral|Exercise Logs|The exercise physiologists will keep exercise logs and tracking sheets that log the date, start and stop time (duration) of exercise sessions as well as time in the THR and RPE for each exercise session.
16097781|NCT02179762|Behavioral|Adherence|We will assess barriers to adhering to the exercise protocol by asking an open-ended question to solicit barriers. If the patient calls to cancel an exercise session, he will be called and probed for reasons
16097782|NCT02179762|Behavioral|Exercise and body composition test|Height will be measured to the nearest 0.1 cm and weight will be measured to the nearest 0.1 kg. Waist and hip circumference will be measured to the nearest 1/8 inch. Whole body dual-energy X-ray absorptiometry scans will be conducted at baseline and end of treatment to quantify total body fat.
16097783|NCT02179749|Drug|Mifepristone 1200 mg daily|Mifepristone, 300 mg tablets, Four tablets daily/am for 1-week duration.
16097784|NCT02179749|Behavioral|Standardized behavioral therapy|Standardized behavioral therapy 1 time per week for 8 week duration.
16097785|NCT02179749|Drug|Placebo|Placebo tablets, Four tablets daily/am for 1-week duration.
16097786|NCT02179736|Device|Restylane|
16097787|NCT02179723|Device|Leukosan Adhesive|Leukosan adhesive applied to one wound
16097788|NCT02179723|Device|Transcutaneous suture|Transcutaneous suture applied to one wound
16097789|NCT02179710|Behavioral|Adherence dashboard motivational interviewing|These data will be aggregated and displayed graphically in weekly intervals. Adherence will be displayed as percentage and timing percentage within a set criterion of prescribed inter-dose interval. Drug holidays, operationally defined as missing two or more consecutive doses will be displayed along with average length. Patient self-reported adherence information, collected via handheld (i.e, smart phone, tablet, laptop) application will be displayed as percentage and timing percentage on the dashboard. Review of dashboard weekly with investigator for motivational interviewing
16097790|NCT02179697|Other|Patient's Choice|Patient chooses between surgery plus bracing or bracing alone. The patient will be followed according to the same schedule as Group 1.
16097791|NCT02179697|Procedure|Surgery + Bracing vs. Bracing Alone|Surgery + Bracing vs. Bracing Alone
16097792|NCT02179684|Procedure|Baby-sitter surgery N. fascialis|
16097793|NCT02179684|Other|Conventional treatment and follow-up|Patient´s with Bells´palasy are treated with conventional treatment and follow-up
16097794|NCT02179671|Drug|Gefitinib|Gefitinib once daily followed by MEDI4736
16097795|NCT02179671|Drug|AZD9291|AZD9291 once daily followed by MEDI4736
16097796|NCT02179671|Drug|Selumetinib+Docetaxel|Selumetinib twice daily + docetaxel, followed by MEDI4736
16097797|NCT02179671|Drug|Tremelimumab|Tremelimumab every 4 weeks followed by MEDI4736
16097798|NCT02179658|Drug|OPT-80|oral
16097799|NCT02179658|Drug|vancomycin|oral
16097800|NCT02179645|Drug|GRC 27864|
16097801|NCT02179645|Drug|Celecoxib|
16097802|NCT02179645|Drug|Placebo|
16097803|NCT02179632|Behavioral|Exposure to disclosure website|Participants are exposed to a physician payment disclosure website.
16097804|NCT02179619|Device|Dermalax(Deep)|Dermalax(Deep) injection into one nasolabial fold (NLF) of one side of the face (blinded, split-face study design) in the Initial Treatment period
16097805|NCT02179619|Device|Restylane|Restylane Injection into one nasolabial fold (NLF) of one side of the face (blinded, split-face study design) in the Initial Treatment period
16097806|NCT02179606|Device|Dermalax Implant Plus|Dermalax implant plus injection into one nasolabial fold(NFL) of one side of the face(blinded, split-face study design) in the initial treatment period.
16097807|NCT02179606|Device|Restylane Sub-Q|Restylane Sub-Q injection into one nasolabial fold(NFL) of one side of the face(blinded, split-face study design) in the initial treatment period.
16097808|NCT02179593|Other|2-Segment SARPE|Le Fort I osteotomy with oppening of the median palatal suture and SARPE.
16097809|NCT02179593|Other|3-Segment SARPE|Le Fort I osteotomy with two parallel osteotomies symetrically positioned with reference to the median palatal suture and SARPE.
16097810|NCT02179580|Drug|Xiang-Sha-Liu-Jun-Zi-Tang|Xiang-Sha-Liu-Jun-Zi-Tang at a rate of 3.0 g three times per day for 28 days. We use the Chinese herb for the treat of IBS patient
16097811|NCT02179580|Drug|Placebo|Xiang-Sha-Liu-Jun-Zi-Tang at a rate of 3.0 g three times per day for 28 days. Placebo drug is 1/10 dose of experiment drug .
16097812|NCT02179567|Drug|Docetaxel|Docetaxel: 60mg/m2 i.v on day 1. Cycle repeated ever 3 weeks
16097813|NCT02179567|Drug|Bevacizumab|Bevacizumab: 7.5 mg/kg, iv on day 1. Cycle repeated every 3 weeks
16097814|NCT02179541|Other|RGB|When a circular area of 30 surrounding pixels are placed exactly upon the above-mentioned standardized points, the Adobe Photoshop Elements 7.0 program automatically measures the numerical values of the RGB color components in that area. The RGB values of the same points on the tympanic membrane images of the two groups were obtained and compared. Diagnostic significance of objectively assessed color changes at the tympanic membrane in OME patients was evaluated.
16097815|NCT02179528|Drug|Etoposide|
16097819|NCT02179502|Drug|GLPG1690, multiple ascending doses, oral suspension|Multiple doses, daily for 14 days, oral suspension, anticipated doses: 300mg to 1000mg
16097820|NCT02179502|Drug|Placebo, multiple ascending doses, oral suspension|Multiple doses, daily for 14 days, oral suspension matching placebo
16097821|NCT02179489|Procedure|Surgery and Hyperthermic Intraperitoneal Chemotherapy with MMC|HIPEC with MMC: Mitomycin C (MMC) (30 mg/m2 of body surface area). Closed technique, as preferred. Duration: 60 minutes. Mean Intra-abdominal Temperature: 43°C.
16097822|NCT02179476|Device|Glyder|The Glyder Facet Restoration Device is intended for minimally invasive bilateral implantation in one or two lumbar facet levels
16097823|NCT02179424|Behavioral|Workshop|Intensive psychological intervention included motivation of quitting enhancement, stress management and smoking triggers, craving and relapse are used to provide smoking cessation intervention
16097824|NCT02179424|Behavioral|Face-to-face counseling|Use motivational interview strategies through face-to-face counseling to provide smoking cessation intervention
16097825|NCT02179424|Behavioral|Phone counseling|Use motivational interview strategies through phone counseling to provide smoking cessation intervention.
16097826|NCT02179424|Behavioral|Health talk|Health talk provided information about hazards of tobacco (active smoking, second- and third-hand smoke), benefits of quitting smoking and methods to quit smoking.
16097827|NCT02179424|Behavioral|Booklet|A 26-page booklet included information about smoking and diseases, benefits of quitting smoking, methods to quit smoking, how to handle withdrawal symptoms, stress management, declaration of quitting smoking, decisional balance of smoking or quitting.
16097828|NCT02179424|Behavioral|SMS|Fifteen SMS were sent to subjects included welcome messages, risk of smoking, correction of myths about smoking or quitting, quitting tips, benefits of quitting, encouragement of quitting
16097829|NCT02179411|Other|tilt test|
16097830|NCT02179398|Biological|Allocation to the Lab-score group|
16097831|NCT02179398|Biological|Allocation to the control group|
16097832|NCT02179385|Behavioral|Health Coaching|
16097833|NCT02179372|Dietary Supplement|Eicosapentaenoic acid|30 subject with Crohn's Disease and/or Ulcerative Colitis in clinical remission but with fecal calprotectin value >150 μg/g will recive 2 g/day of Eicosapentaenoic acid for 6 months treatment. At 3 months and 6 months, fecal calprotectin and clinical activity (CDAI for Crohn's Disease and SCCAI for Ulcerative Colitis) will be measured. The effect of Eicosapentaenoic acid on fecal calprotectin level will be monitored. Clinical relapses will be considered during the study.
16097834|NCT02179372|Dietary Supplement|Medium chain fatty acid (placebo)|30 subject with Crohn's Disease and/or Ulcerative Colitis in clinical remission but with fecal calprotectin value >150 μg/g will recive 2 g/day of medium chain fatty acids for 6 months treatment. At 3 months and 6 months, fecal calprotectin and clinical activity (CDAI for Crohn's Disease and SCCAI for Ulcerative Colitis) will be measured.
16097835|NCT02179359|Drug|Reduced Toxicity Ablative Regimen|"Anti-thymocyte Globulin (ATG)
~Fludarabine
~Busulfan
~Stem Cell Infusion Day 0"
16097836|NCT02179359|Drug|Reduced Intensity Preparative Regimen|"Alemtuzumab
~Cyclophosphamide
~Fludarabine
~Total Body Irradiation (TBI)
~Stem Cell Infusion Day 0"
16097837|NCT02179359|Drug|Myeloablative Preparative Regimen|"Alemtuzumab
~Cyclophosphamide
~Busulfan
~Stem Cell Infusion Day 0"
16097838|NCT02179333|Other|Ataxia rating scale|Administer new rating scale for ataxia. This will be administered by two different raters on two separate occassions, 4 to 6 weeks apart.
16097839|NCT02179320|Procedure|Dry needling|Dry needling of the painful muscles, with an acupuncture needle 0,25 x 40mm
16097840|NCT02179320|Device|acupuncture needle 0,25 x 40mm|
16097841|NCT02179307|Behavioral|12-week progressive strength training protocol|Every study participant will complete 12 weeks of progressive strength training with one leg performing 1-set per exercise per session and the contralateral leg performing 3-sets per exercise per session. Allocation of dominant/non-dominant leg to either 1- or 3-set protocol will be done in a stratified, randomized fashion (stratified with regard to sex and baseline strength).
16097842|NCT02179294|Drug|Pethidine|100mg by intramuscular injection, up to 4 hourly in frequency (up to a maximum of 4 doses). The maximum dose being 400mg in 24 hours.
16097843|NCT02179294|Drug|Remifentanil|"Dedicated intravenous cannula for remifentanil administration PCA protocol
~PCA bolus remifentanil 40 μg
~Lockout interval 2 minutes
~In the event of excess sedation being recorded by regular observation of respiratory function, the regimen will be altered by reduction of the remifentanil bolus dose to 30 μg with a lock-out interval of 2 minutes."
16097844|NCT02179281|Device|Medtronic MiniMed™ 640G system|The MiniMed™ 640G system is indicated for the continuous delivery of insulin, for continuous or periodic monitoring of glucose levels in the fluid under the skin, with a feature for a prediction of low or high glucose episodes.
16097845|NCT02179268|Drug|sertraline|50mg, 50-150mg/d,qd for one year
16097846|NCT02179268|Drug|citalopram|20mg, 20-40mg/d,qd,for one year
16097847|NCT02179268|Drug|venlafaxine|venlafaxine,25mg, 75-100mg/d, bid, for one year
16097848|NCT02179268|Drug|reboxetine|reboxetine,4mg, 4-8mg/d,qd for one year
16097849|NCT02179268|Behavioral|control|50min, every week for three months, every month, for nine months
16097850|NCT02179255|Drug|Human Growth Hormone|1.9 mg (5.7 units) daily injection of Recombinant Human Growth Hormone (HGH) for at least 6 weeks (42 days) continuing into the approximately 14 days of ovulation induction phase of the trial.
16097851|NCT02179255|Drug|Follicle Stimulating Hormone|FSH 450 to 600 units per day administered SQ daily dose adjusted based on the patients response starting on day 2 of the 28 day menstrual cycle and continued until Ovulation trigger
16097852|NCT02179242|Other|Cardiac rehab|
16097853|NCT02179229|Dietary Supplement|CONTROL|Placebo will be taken at home for four weeks as 5 g powder packets to be dissolved in water three times a day far from meals.
16097854|NCT02179229|Dietary Supplement|SYNBIOTIC|Probinul Neutro® will be taken at home for four weeks as 5 g powder packets to be dissolved in water three times a day far from meals.
16097855|NCT02179216|Other|Hydration|Hydratation the first day in the arm 1 Hydration the second day in the arm 2
16097856|NCT02179216|Other|Venous contention|Venous contention the second day in the arm 1 Venous contention the first day in the arm 2
16097857|NCT02179190|Device|BARREL VRD|The Barrel VRD was implanted as adjunctive to embolic coils in subjects with wide necked bifurcating aneurysms within the Middle Cerebral and Basilar Arteries.
16097860|NCT02179151|Drug|ZGN-440 for Injectable Suspension|Subjects will receive ZGN-440 twice weekly subcutaneous injections for up to 28 weeks.
16097861|NCT02179151|Drug|ZGN-440 Placebo for Injectable Suspension|Subjects will receive placebo twice weekly subcutaneous injections for up to 28 weeks.
16097862|NCT02179138|Drug|TFV 1% gel|
16097863|NCT02179125|Device|RePneu Lung Volume Reduction Coil System|Bronchoscopic lung volume reduction treatment with Coils.
16097864|NCT02179112|Procedure|Emergency Abdominal Surgery|Emergency intra-peritoneal surgery (only exclusion: Caesarian section).
16097865|NCT02179099|Device|BTX mixed with TC-3 Gel|Patients will be treated with a single intravesical instillation of 40 ml TC-3 gel mixed with 300U BTX
16097866|NCT02179086|Radiation|3-dimensional conformal radiation therapy|Undergo standard-dose 3D-CRT
16097867|NCT02179086|Radiation|intensity-modulated radiation therapy|Undergo standard-dose IMRT
16097868|NCT02179086|Radiation|photon beam radiation therapy|Undergo dose-escalated and -intensified photon IMRT
16097869|NCT02179086|Radiation|intensity-modulated radiation therapy|Undergo dose-escalated and -intensified photon IMRT
16097870|NCT02179086|Radiation|proton beam radiation therapy|Undergo dose-escalated and -intensified proton beam radiation therapy
16097871|NCT02179086|Drug|temozolomide|Given PO
16097872|NCT02179086|Other|laboratory biomarker analysis|Correlative studies
16097873|NCT02179047|Procedure|coronary angiography|percutaneous coronary intervention. coronary angiography.
16097874|NCT02179034|Drug|Nicotine|Participants will receive no nicotine, low dose nicotine (6 mg/ml) or high dose nicotine (12 mg/ml)
16097875|NCT02179034|Other|Low Dose Menthol|A low dose of menthol will be added to the tobacco flavor.
16097876|NCT02179034|Other|High Dose Menthol|A high dose of menthol will be added to the tobacco flavor.
16097877|NCT02179008|Drug|DE-117 Low Dose ophthalmic solution|Low Dose DE-117 ophthalmic solution
16097878|NCT02179008|Drug|DE-117 Low/Middle Dose ophthalmic solution|Low/Middle Dose DE-117
16097879|NCT02179008|Drug|DE-117 Middle Dose ophthalmic solution|Middle Dose DE-117
16097880|NCT02179008|Drug|DE-117 Middle/High Dose ophthalmic solution|Middle/High Dose DE-117
16097881|NCT02179008|Drug|DE-117 High Dose ophthalmic solution|High Dose DE-117
16097882|NCT02179008|Drug|latanoprost ophthalmic solution 0.005%|0.005% latanoprost
16097883|NCT02178995|Drug|Methylphenidate|"Participants with epilepsy will first receive blinded, single-dose capsules which contain either:
~Placebo 20mg of methylphenidate or 10mg of methylphenidate.
~At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed."
16097884|NCT02178956|Drug|BBI608|BBI608 480 mg orally two times daily (960 mg total daily dose)
16097885|NCT02178956|Drug|Paclitaxel|Paclitaxel 80 mg/m2 I.V. infusion on Days 1, 8, and 15 of every 4-week cycle
16097886|NCT02178956|Other|Placebo|Orally two times daily
16097887|NCT02178930|Other|Integrated self management support|The intervention comprises a consultation engagement, at home exploration, phone and web-based health coaching.
16097888|NCT02178917|Other|Neurofeedback therapy|
16097889|NCT02178917|Other|No neurofeedback therapy|
16097890|NCT02178904|Procedure|CT and stress test|Coronary computed tomographic angiography (CCTA) plus computed tomography stress myocardial perfusion imaging (CTP)
16097891|NCT02178891|Device|extra short implant|
16097892|NCT02178878|Genetic|Progress, Pain|Progress, Pain
16097893|NCT02178852|Device|TRIGEMINAL NERVE STIMULATION (TNS)|TNS stimulation over V1 branches of V cranial nerve. Single session for 30 minutes. The patient will undergo a specific cue-induced cigarette craving model during the final 3 minutes of stimulation. Craving scores will be rated before and after stimulation
16097894|NCT02178839|Dietary Supplement|β- glucan|8.5 g/d of Oat Supplement Containing 3g β- glucan
16097895|NCT02178839|Dietary Supplement|Maltodextrin|8.5 g/d Maltodextrin
16097896|NCT02178826|Device|Rapid Maxillary Expansion|The Rapid Maxillary Expander will over 10-14 days create a palatal expansion of about 5mm.
16097897|NCT02178826|Device|Placebo Appliance|The Placebo Appliance looks exactly like the Rapid maxillary Expander but the expansion screw does not work. When the expansion screw is activated it does not create a palatal expansion.
16097898|NCT02178813|Drug|Administration of minocycline|"Administration of minocycline with the following schedule:
~Day prior to procedure: 800mg p.o., 700mg p.o.
~Day of procedure: 600mg i.v., 500mg p.o.
~Day after procedure: 400mg p.o., 400mg p.o."
16097903|NCT02178761|Device|drug-eluting balloon|angioplasty completed with drug-eluting balloons
16097904|NCT02178761|Device|biodegradable vascular scaffold stent|Stenting with biodegradable vascular scaffold stents
16097905|NCT02178761|Device|Apex™ PTCA Dilatation Catheter|plain old balloon angioplasty alone
16097906|NCT02178761|Device|Stent System|stenting with either bare-metal stents or drug-eluting stents
16097907|NCT02178748|Biological|MVA85A|Single dose of 1x10^8pfu MVA85A intramuscular vaccination
16097908|NCT02178735|Procedure|Anterior vaginal tailored mesh surgery|Anterior vaginal tailored mesh surgery for repair of cystocele with or without stress urinary incontinence
16097909|NCT02178735|Procedure|Posterior vaginal tailored mesh surgery|Posterior vaginal tailored mesh surgery for repair of enterocele, rectocele, vaginal vault prolapse or uterine prolapse
16097910|NCT02178722|Drug|MK-3475|IV infusion
16097911|NCT02178722|Drug|INCB024360|Oral daily dosing
16097912|NCT02178709|Drug|FOLFIRINOX|"FOLFIRINOX consists of the following combination of drugs:
~Oxaliplatin, 85 mg/m2, IV over 2 hours prior to irinotecan, administered on days 1 and 15 of each 28 day cycle
~Leucovorin, 400 mg/m2, IV over 2 hours with irinotecan, administered on days 1 and 15 of each 28 day cycle
~Irinotecan, 180 mg/m2, IV over 90 minutes with leucovorin, administered on days 1 and 15 of each 28 day cycle 4.5 FU, 400 mg/m2, IV bolus over 2 minutes after irinotecan, administered on days 1 and 15 of each 28 day cycle.
~5.5FU, 2400 mg/m2, IV infusion over 46 hours after 5FU bolus injection, administered on days 1 and 15 of each 28 day cycle."
16097913|NCT02178696|Other|Placebo, identified as placebo to participants|White tablets
16097914|NCT02178696|Drug|Celexa or other antidepressant as clinically indicated|Open label s-citalopram, 20 mg start up dose, increasing to 40 mg as clinically indicated; If prior non-response to this medication is noted by the patient, alternative treatments may include another first-line antidepressant:fluoxetine 20 mg; paroxetine up to 60 mg; sertraline up to 200 mg; bupropion up to 300 mg
16097915|NCT02178696|Other|"Placebo, identifed to participants as Active medication"|Blue Capsule
16097916|NCT02178683|Drug|Tacrolimus and MMF.|First dose of Tacrolimus is given day -4, this continues through day +365. First dose of MMF is given within 4 hours of stem cell infusion, this continues through day +365.
16097917|NCT02178670|Biological|CSC-DC|
16097918|NCT02178657|Drug|Autologous bone marrow mononuclear cell intra-arterial injection|
16097919|NCT02178644|Drug|Chemo with concomitant Capecitabine and KD018|Patients will receive a course of chemo-radiation with concomitant Capecitabine and KD018, and to compare this to the toxicity seen in patients treated with Capecitabine and radiation therapy alone, in patients with T3-T4 and N0-N2, M0 rectal cancer.
16097920|NCT02178631|Behavioral|Deprexis|Online self-help
16097921|NCT02178631|Other|CAU|Care as usual
16097922|NCT02178618|Device|Deployment of Partially covered biliary self expandable metal stent|
16097923|NCT02178618|Device|Deployment of uncovered biliary self expandable metal stent|
16097924|NCT02178605|Procedure|Cervical arthrodesis with rhBMP-2|Cervical arthrodesis with rhBMP-2
16097925|NCT02178592|Drug|DTG 50 mg|DTG is available as 50 mg film-coated tablet. DTG may be administered with or without food
16097926|NCT02178592|Drug|EFV 600 mg|EFV is supplied as film-coated capsule-shaped oral tablet containing 600 mg of EFV and must be administered without food
16097927|NCT02178566|Drug|Inhaled Treprostinil|A dose of inhaled treprostinil or placebo will be administered to all study participants prior to each of their Pulmonary Rehab sessions. Three puffs of inhaled treprostinil dose will be administered each time to all patients .
16097928|NCT02178553|Drug|Epidural|
16097929|NCT02178553|Drug|Intercostal Bupivicaine (Exparel)|
16097930|NCT02178540|Drug|Placebo|one dose (4 capsules) of placebo
16097931|NCT02178540|Device|Tobi Podhaler|The capsule containing the study medication has to be released from the blister card, be inserted into the Podhaler device, actuated and the study drug be inhaled according to instructions for use
16097932|NCT02178527|Other|Foot and ankle exercises, foot orthoses, footwear provision|Participants in the intervention group will receive orthoses and footwear as part of the study. The research team will train care home staff in the provision of foot and ankle exercises. The exercise protocol states that exercises will be carried out 3 times per week for 12 weeks.
16097933|NCT02178527|Other|Usual Care|Usual general podiatry care provded by UK National Health Service
16097934|NCT02178514|Other|Formula fed with BabyNes Nutrition System|
16097935|NCT02178501|Dietary Supplement|Omega-3 PUFA|comparison of omega-3 PUFA supplementation 2000 mg once daily (1000 mg EPA and 1000 mg DHA) versus placebo
16097936|NCT02178488|Drug|Cholecalciferol|Cholecalciferol 4000 IU/day for 12 months
16097937|NCT02178488|Other|Placebo|Placebo (mimic of cholecalciferol) in the same amount and same time frame as Cholecalciferol for 12 months
16097938|NCT02178449|Drug|Dexamethasone acetate|
16097939|NCT02178449|Drug|Placebo|
16097940|NCT02178449|Drug|Ropivacaine|
16097941|NCT02178436|Drug|gemcitabine hydrochloride|Given IV
16097942|NCT02178436|Drug|Selinexor|Given IV
16097943|NCT02178436|Other|Pharmacological Study|Correlative studies
16097944|NCT02178436|Other|Laboratory Biomarker Analysis|Correlative studies
16097945|NCT02178436|Drug|Nab paclitaxel|Given IV
16097946|NCT02178423|Procedure|Ultrasound for diagnosis of CVC position in children|Using the ultrasound for diagnosis of the correct position of a central venous catheter in children immediate after the puncture.
16097947|NCT02178410|Dietary Supplement|Vitamin D3|Vitamin D3 (cholecalciferol), 2000 IU per day.
16097948|NCT02178410|Drug|Omega-3 fatty acids (fish oil)|Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
16097949|NCT02178410|Dietary Supplement|Fish oil placebo|Fish oil placebo
16097950|NCT02178410|Dietary Supplement|Vitamin D3 placebo|Vitamin D3 placebo
16097951|NCT02178397|Drug|ERLOTINIB WITH CHEMOTHERAPY|
16097952|NCT02178397|Drug|CHEMOTHERAPY ONLY|
16097953|NCT02178384|Procedure|Altered cast technique|This techniques deals with the procedures that are employed when constructing the removable partial denture on working casts.
16097954|NCT02178384|Device|Precision Attachments|These are minor attachments used to split the loading forces during appliance wear
16097955|NCT02178384|Procedure|Resilient layer|This is a layer beneath the appliance which helps in reducing the transmission of loading forces to the underlying soft tissues
16097956|NCT02178371|Procedure|mCIMT|affected upper limb use with constraint of the healthy hand
16097957|NCT02178371|Procedure|Unimanual therapy without constraint UTWC|affected upper limb use without constraint of healthy hand
16097958|NCT02178358|Drug|LY2157299|Administered orally
16097959|NCT02178358|Drug|Sorafenib|Administered orally
16097960|NCT02178358|Drug|Placebo|Administered orally
16097961|NCT02178345|Procedure|diffusion weighted (DW) MRI|
16097962|NCT02178345|Procedure|dynamic contrast agent (DCE) MRI|
16097963|NCT02178332|Other|Yhteispeli, whole school programme|
16097964|NCT02178332|Other|Two theoretical lectures|
16098094|NCT02177448|Drug|Placebo matching enalapril|
16098095|NCT02177435|Drug|Telmisartan|
16097965|NCT02178319|Procedure|open surgical procedure|open esophagogastric devascularization and splenectomy will perform as surgical procedure in the patients
16097966|NCT02178319|Procedure|laparoscopic surgical procedure|laparoscopic esophagogastric devascularization and splenectomy will perform as surgical procedure in the patients
16097967|NCT02178306|Drug|Telmisartan low dose|
16097968|NCT02178306|Drug|Telmisartan high dose|patients switch to high dose if mean SBP >= 85 mmHg after 4 weeks of treatment
16097969|NCT02178306|Drug|Placebo|Run-in phase
16097970|NCT02178293|Drug|Benzidamine hydrochloride|
16097971|NCT02178293|Drug|Ketoprofen lysine salt|
16097972|NCT02178280|Other|liver transplantation combined with neoadjuvant therapy|liver transplantation combined with neoadjuvant radiochemotherapy
16097973|NCT02178267|Dietary Supplement|Lactobacillus reuteri (biogai AB, Sweden)|Lactobacillus reuteri (biogai AB, Sweden) was given to probiotic group, same way to all newborn newborn preterm infants, directly oral feeding and without any along with a mixture, admission following the in nicu, as a daily dose 1x108 cfu / day (1x5 drops / day) during hospitalization
16097974|NCT02178254|Drug|Fosfomycin tromethamine|A phosphonic acid derivative is the mono-acid salt of Fosfomycin with Tromethamine. Sequence 1-3 receive 3 grams oral sachet
16097975|NCT02178254|Drug|Fosfomycin disodium|ZTI-01 is a phosphonic acid derivative formulated as a disodium salt intravenous formulation. ZTI-01 acts by inhibiting peptidoglycan assembly, thereby disrupting cell wall synthesis. Sequence 1-3 receive 1 gram and 8 grams of Intravenous ZTI-01 for 1-hour infusion
16097976|NCT02178241|Drug|Eribulin Mesylate|Given IV
16097977|NCT02178241|Drug|Gemcitabine Hydrochloride|Given IV
16097978|NCT02178215|Other|Placebo shower gel|Wash forearm with placebo shower gel for 10 seconds, twice a day, 2 weeks
16097979|NCT02178215|Other|Holly Mangrove Shower Gel|Wash forearm with Holly Mangrove shower gel containing Acanthus ebracteatus Vahl for 10 seconds, twice a day, 2 weeks
16097980|NCT02178202|Behavioral|McKenzie exercise|First to sixth McKenzie exercises were performed for 5 times/week and 10 treatment sessions totally.
16097981|NCT02178202|Device|Harmonic technique|Lower limb suspension exercise was performed for 5 times/week and 10 treatment sessions totally
16097982|NCT02178189|Other|High Calorie Infant formula|Infants were randomized to be fed high calorie formula from 72 hours of life until age 21 days.
16097983|NCT02178189|Other|Standard Calorie Infant Formula|Infants were randomized to be fed standard calorie formula from 72 hours of life until age 21 days.
16097984|NCT02178176|Behavioral|Education, encouragement, card sort|"Patients will identify factors involved in nonadherence. For each factor influencing adherence, the interventionist will engage the patient in a 4-step problem solving process.
~We will recognize patients' social and cultural context by addressing health-related priorities identified by the patient. The goal will be to identify those priorities which are likely to influence engagement in care and adherence to treatment. We will assess both biomedical (physical symptoms, diet and exercise) and nonbiomedical (financial, social and emotional) needs patients with Type 2 diabetes mellitus and depressive symptoms may wish to discuss in the context of their health. After the patients complete the card sort, interventionists will engage the patient in the 4-step problem solving process."
16097985|NCT02178176|Behavioral|Education, encouragement|Patients will identify factors involved in nonadherence. For each factor influencing adherence, the interventionist will engage the patient in a 4-step problem solving process.
16097986|NCT02178163|Other|cytology specimen collection procedure|Correlative studies
16097987|NCT02178163|Other|laboratory biomarker analysis|Correlative studies
16097988|NCT02178150|Dietary Supplement|Magnesium Oxide|This is a double-blind randomized clinical trial which will be started at June 2014 and end on June 2015 in Isfahan city. Serum insulin level is considered as a key variable and the sample size was calculated to be 70 persons (35 persons for control group and 35 persons for patient group). Patient group will receive magnesium supplement (250 milligram) and the other group will receive placebo which is similar to the magnesium tablets in color, odor and appearance both for 8 weeks. All subjects will complete 4 physical activity and 4 dietary records. Outcome measurements including metabolic and inflammatory profiles,sex hormone levels will be measured at the beginning and end of the study as well as anthropometric measurements.
16097989|NCT02178150|Dietary Supplement|Placebo|
16097990|NCT02178137|Drug|Diacerien|
16097991|NCT02178137|Drug|Glucosamine/Chondroitin|
16097992|NCT02178137|Drug|Placebo|
16097993|NCT02178124|Drug|Donepezil|
16097994|NCT02178124|Drug|placebo|
16097995|NCT02178111|Other|Never perform episiotomy|In this group birth attendants will be sought to avoid at all cost episiotomy. The intention is to never perform episiotomy in this group.
16097996|NCT02178111|Procedure|episiotomy|
16097997|NCT02178098|Drug|ETC-1002|ETC-1002 capsules taken once daily
16097998|NCT02178098|Drug|Placebo|Placebo capsules taken once daily
16097999|NCT02178085|Other|Flow imaging|Participants will undergo morphological and then flow MRI. Flow MR images will be processed adequately to obtain quantitative values of arterial and venous flow as well as CSF flow.
16098000|NCT02178072|Drug|5-Azacitadine|
16098001|NCT02178059|Drug|terbutaline sulphate delivered dose|0.4 mg terbutaline sulphate (delivered dose) per inhalation
16098002|NCT02178059|Drug|terbutaline sulphate metered dose|0.5 mg terbutaline sulphate (metered dose) per inhalation
16098003|NCT02178046|Device|optical measurements|Laser Speckle Imaging, Optical Coherence Tomography and Multiphoton Microscopy
16098004|NCT02178033|Drug|Split dose low-volume PEG solution|"All participants will receive low-volume (2L) PEG plus ascorbic acid solution (MOVIPREP®, Norgine, Harefield, United Kingdom); in the control arm the whole colonoscopy preparation is administered the day before colonoscopy; in the  active comparator  arm one liter of the bowel preparation is administered on the evening before the colonoscopy and the remaining liter on the day of the procedure."
16098005|NCT02178020|Device|knee arthroplasty, standard polyethylene|total knee replacement follow-up; clinical and radiographic; revision rate
16098006|NCT02178020|Device|knee arthroplasty, XLP polyethylene|total knee arthroplasty with highly crosslinked polyethylene tibial liner
16098096|NCT02177435|Drug|Telmisartan/Hydrochlorothiazide|
16098097|NCT02177435|Drug|Placebo|
16098098|NCT02177422|Drug|Telmisartan|telmisartan 80 mg once daily
16098007|NCT02177994|Drug|ceftriaxone 1gm for intravenous infusion|Patients undergoing elective cesarean section with Gestational age 37 weeks or more. comparing the effect of administration of 1 gm ceftriaxone in elective cesarean section 30-60 min before skin incision versus after cord clamping.on post-cesarean section infection(wound infection as a primary outcome)
16098008|NCT02177981|Procedure|Remote ischemic preconditioning|A blood pressure cuff will be placed on the left arm and three cycles of 5 min ischemia followed by 5 min reperfusion will be applied.
16098009|NCT02177981|Procedure|Control|The cuff will be placed around the arm but not inflated.
16098010|NCT02177968|Other|descriptive analysis of characteristics|comparison between elderly fallers and non-fallers
16098011|NCT02177955|Drug|7.5 mg Midazolam|7.5 mg midazolam 45 minutes before surgery
16098012|NCT02177955|Drug|10 mg diazepam|10 mg midazolam 45 minutes before surgery
16098013|NCT02177942|Other|Test beverage powder (High Proteins and added micronutrients)|High protein and added Micronutrients at recommended dietary allowance levels
16098014|NCT02177942|Other|Control beverage powder (Low protein and no added micronutrients)|Low protein and no added micronutrients
16098015|NCT02177929|Other|adapted canoeing, hadbike and conventional physiotherapy|"The subjects adapted canoeing group will practice on the kayak and rowing exercises associating with ball.
~The individuals in the group will handbike workouts outdoors and surpassing cirucuitos mounted with cones.
~Individuals in the conventional physiotherapy group will make stretching and strengthening exercises."
16098016|NCT02177916|Other|Education|
16098017|NCT02177903|Device|Bair Paws Patient Adjustable Warming System|Bair Paws system uses forced-air warming. This system will be used for patients randomized to active pre-warming.
16098018|NCT02177890|Device|Transcutaneous vagal nerve stimulation|
16098019|NCT02177890|Device|Sham vagal nerve stimulation|
16098020|NCT02177864|Dietary Supplement|Fiber|
16098021|NCT02177864|Other|Placebo (low fiber bar)|
16098022|NCT02177851|Dietary Supplement|Single oral iron dose of 120 mg per day for 3 consecutive days|
16098023|NCT02177851|Dietary Supplement|Two oral iron doses of 60 mg per day (morning + afternoon) for 3 consecutive days|
16098024|NCT02177838|Biological|cetuximab|Given IV
16098025|NCT02177838|Drug|cisplatin|Given IV
16098026|NCT02177838|Radiation|external beam radiation therapy|Undergo EBRT
16098027|NCT02177838|Other|laboratory biomarker analysis|Correlative studies
16098028|NCT02177825|Drug|Imatinib Mesylate|oral administration
16098029|NCT02177812|Drug|GSK2879552|GSK2879552 capsules contain 0.25 mg, 0.5 mg, 2 mg or 5 mg of GSK2879552 as parent. The initial dosing regimen will be continuous oral daily dosing.
16098030|NCT02177812|Drug|ATRA|ATRA (Tretinoin) will be supplied as a 10 mg capsule for oral administration. The initial dosing regimen will be continuous oral twice daily dosing
16098031|NCT02177786|Drug|Selonsertib|Tablets administered orally once daily
16098032|NCT02177786|Drug|Placebo to match selonsertib|Tablets administered orally once daily
16098033|NCT02177773|Procedure|Computed Tomography (CT)|Undergo Gallium Ga 68-DOTA-TOC PET/CT
16098034|NCT02177773|Drug|Gallium Ga 68-Edotreotide|Given Intravenously (IV) before imaging
16098035|NCT02177773|Procedure|Magnetic Resonance Imaging (MRI)|Undergo gallium Ga 68-DOTA-TOC PET/MRI
16098036|NCT02177773|Procedure|Positron Emission Tomography (PET)|Undergo gallium Ga 68-DOTA-TOC PET in combination with CT or MRI
16098037|NCT02177760|Drug|Sirolimus|
16098038|NCT02177747|Other|Ophthalmoscopy conducted using a smartphone equipped with a compact addon|
16098039|NCT02177747|Device|Smartphone|
16098040|NCT02177734|Biological|Investigational H7N9 vaccine GSK3277510A|One dose of GSK3277510A H7N9 vaccine administered intramuscularly (IM) in the deltoid region of non-dominant arm at Day 0 and the second dose of GSK3277510A H7N9 vaccine administered IM in the deltoid region of dominant arm at Day 21
16098041|NCT02177734|Biological|Investigational H7N9 vaccine GSK3277509A|One dose of GSK3277509A H7N9 vaccine administered IM at the deltoid region of non-dominant arm at Day 0 and the second dose of GSK3277509A H7N9 vaccine administered IM at the deltoid region of dominant arm at Day 21
16098042|NCT02177734|Biological|Placebo|One dose of placebo administered IM at the deltoid region of non-dominant arm at Day 0 and the second dose of placebo administered IM at the deltoid region of dominant arm at Day 21
16098043|NCT02177721|Biological|Collection of samples|"Whenever possible serum samples will be collected from all subjects to determine serum raxibacumab concentrations pre-infusion, and at specific timepoints post-infusion. In the event cerebrospinal fluid (CSF), pleural, ascites, or bronchoalveolar lavage (BAL) fluid are collected for ad hoc clinical laboratory testing, any remaining excess sample will be provided to Sponsor for determination of raxibacumab concentrations.
~Any available serum remaining from ad hoc clinical laboratory specimen collections prior to raxibacumab administration will be provided to Sponsor for measurement of serum PA concentrations. In addition, remaining post raxibacumab dose serum specimens may also be analyzed for TNA or ADA."
16098044|NCT02177695|Drug|Gemcitabine|Gemcitabine, 1000 mg/m2, IV (in the vein) on Days 1 and 8 of each 21 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
16098045|NCT02177695|Drug|Cisplatin|"Cisplatin, 70 mg/m2, IV (in the vein) on Day 1 of each 21 day cycle (or Day 1 or 2 of each 14 day cycle).
~Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops."
16098046|NCT02177695|Drug|Methotrexate|Methotrexate, 30 mg/m2, IV (in the vein) on Days 1 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
16098047|NCT02177695|Drug|Vinblastine|Vinblastine, 3 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
16098048|NCT02177695|Drug|Doxorubicin|Doxorubicin, 30 mg/m2, IV (in the vein) on Days 1 or 2 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
16098049|NCT02177695|Drug|Filgrastim|Filgrastim, 5 mcg/kg, SubQ/IV (in the vein) on Days 3-7 of each 14 day cycle. Number of Cycles: 4 cycles or until progression or unacceptable toxicity develops.
16098050|NCT02177682|Drug|Afuresertib|Size 4 and Size 1 opaque white capsules containing 25 mg and 100 mg of afuresertib, respectively, to be administered orally.
16098051|NCT02177669|Other|quick Contrast Sensitivity Function test|
16098279|NCT02176200|Drug|Berodual® Respimat®, low inspiratory flow rate|
16098052|NCT02177656|Behavioral|Motivational Interviewing tailored intervention|MI is grounded in client-centered counseling, cognitive-behavioral therapy, and social cognitive therapy. MI integrates the concepts of relationship building from humanistic therapy with active strategies oriented towards stages of change.The main characteristics of motivational interviewing are: expressing empathy, developing discrepancy, rolling with resistance, and supporting self-efficacy. The interviewer maintains a nonjudgmental approach and allows the patient to determine the need for behavioral change, rather than offering unsolicited advice on the need for change. The interviewer only explores ways to implement change once the patient expresses the desire and confidence to change. The goal of MI is to help individuals work through inherent ambivalence present in problematic or unhealthy behaviors and to help them verbally express reasons for or against change using a nonjudgmental, empathetic and encouraging tone.
16098053|NCT02177643|Drug|Diacerein|Diacerein oral capsules
16098054|NCT02177643|Drug|Placebo|Placebo oral capsules
16098055|NCT02177630|Other|Endomyocardial Biopsy|
16098056|NCT02177617|Drug|Botox injection|Participants will receive a tailored dose of Botox to address their Cervical Dystonia symptoms
16098057|NCT02177617|Behavioral|Physical Therapy|Participants will undergo physical therapy sessions with a physical therapist trained in movement disorders. Participants will be instructed to continue these exercises five times per week, and will be called weekly by the investigator to check progress.
16098058|NCT02177617|Procedure|Transcranial magnetic stimulation (TMS)|For these tests, participants will sit in a chair that looks like one found at the dentist's office. A nerve stimulator will be placed on the wrist of the right hand to stimulate the median and ulnar nerves. The intensity of the nerve stimulator will be gradually increased until the right thumb begins to twitch. A magnetic coil will be placed on the scalp on the left side of the head, overlying the brain's motor cortex, to stimulate the brain's output to the muscles in the opposite hand. This procedure will be repeated using the left wrist and the right side of the head.
16098059|NCT02177604|Other|Wingate HIT|"3 sessions of Wingate based High-Intensity Interval Training (6-8 x 15 second all out sprints on a cycle ergometer interspersed by 2 minutes recovery)"
16098060|NCT02177604|Other|Modified HIT|3 sessions of Modified High-Intensity Interval Training (8 x 60 second sprints at approximately 90-95% VO2 peak on a cycle ergometer interspersed by 60 seconds recovery)
16098061|NCT02177604|Other|High-fat overfeeding|7 days of high-fat overfeeding (50% excess calories)
16098062|NCT02177578|Drug|Temozolomide|Patients will be scheduled to receive continuous daily temozolomide (75 mg per square meter of body surface area per day, 7 days per week from the first to the last day of radiation therapy), followed by 6 cycles of adjuvant temozolomide (150 to 200 mg per square meter for 5 days during each 28 day cycle).
16098063|NCT02177578|Radiation|Subventricular Zone radiation|"Patients will receive 60 Gy in 30 fractions, 5 days per week using IMRT. The target delineation and treatment volumes will be as follows:
~Initial treatment plan:
~Will be prescribed to 46 Gy in 2 Gy fractions
~Cone down treatment plan:
~Will be prescribed to 14 Gy in 2 Gy fractions"
16098064|NCT02177578|Radiation|Neural Progenitor Cell Sparing radiation|"Patients will receive 60 Gy in 30 fractions, 5 days per week using IMRT. The target delineation and treatment volumes will be as follows:
~Initial treatment plan:
~Will be prescribed to 46 Gy in 2 Gy fractions
~Cone down treatment plan:
~Will be prescribed to 14 Gy in 2 Gy fractions"
16098065|NCT02177565|Biological|carrier plus in vitro expanded autologous BMSCs|The non-unions of fractures were stabilized with internal or external fixation devices. The non-union site was clearly exposed and decorticated to introduce sub-periosteal bone graft. Depending on the surgical approach, the site was partitioned in either medial/lateral or anterior/posterior sides. The contents of each universal container were mixed individually with a carrier by the surgeon, who was blinded to the contents of the container
16098066|NCT02177552|Drug|Carboplatin|
16098067|NCT02177552|Drug|Docetaxel|
16098068|NCT02177552|Drug|Capecitabine|
16098069|NCT02177552|Drug|Epirubicin|
16098070|NCT02177552|Drug|Oxaliplatin|
16098071|NCT02177539|Drug|Cyclopentolate|Traditional scheme. Cyclopentolate, repeat dosage 5 minutes and then wait 40 minutes to retinoscopy. Total wait 45 minutes.
16098072|NCT02177539|Drug|Cyclopentolate+tropicamide+phenylephrine|New scheme. All drugs together and wait 30 minutes for retinoscopy
16098073|NCT02177526|Device|Imaging|15 patients with malignant comedo-type necrosis and calcifications detected with histo-pathology from guided biopsies will be enrolled after obtaining informed consent. 15 patients with biopsy proven Gleason pattern 5 tumor and without comedo-type necrosis associated calcification will serve as a comparison group after providing informed consent for a total of 30 patients.
16098074|NCT02177513|Drug|Placebo + Placebo|Participants will consume a brownie containing the equivalent of one placebo (0.001% THC) cigarette followed by smoking or inhaling (after vaporization) the equivalent of one placebo (0.001% THC) cigarette.
16098075|NCT02177513|Drug|Oral Cannabis + Placebo|Participants will consume a brownie containing the equivalent of one active (6.9% THC) cannabis cigarette followed by either smoking or inhaling (after vaporization) the equivalent of one placebo (0.001% THC) cigarette.
16098076|NCT02177513|Drug|Placebo + Inhaled Cannabis|Participants will consume a brownie containing the equivalent of one placebo (0.001% THC) cigarette
16098077|NCT02177513|Drug|Placebo + Smoked Cannabis|Participants will consume a brownie containing the equivalent of one placebo (0.001% THC) cigarette followed by smoking the equivalent of one active (6.9% THC) cigarette.
16098078|NCT02177513|Drug|6.9% cannabis oral|Participants will consume a brownie containing the equivalent of one active (6.91% THC) cannabis cigarette.
16098079|NCT02177500|Drug|Telmisartan + hydrochlorothiazide|
16098080|NCT02177500|Drug|Telmisartan|
16098081|NCT02177500|Drug|Placebo|
16098082|NCT02177487|Drug|Telmisartan/hydrochlorothiazide|
16098083|NCT02177474|Behavioral|Telephone based peer support|
16098084|NCT02177461|Drug|Telmisartan|
16098085|NCT02177461|Drug|Enalapril|
16098086|NCT02177461|Drug|Clonidine|
16098087|NCT02177448|Drug|BIBR277 low dose|
16098088|NCT02177448|Drug|BIBR277 medium dose|
16098089|NCT02177448|Drug|BIBR277 high dose|
16098090|NCT02177448|Drug|Enalapril low dose|
16098091|NCT02177448|Drug|Enalapril medium dose|
16098092|NCT02177448|Drug|Enalapril high dose|
16098093|NCT02177448|Drug|Placebo matching BIBR277|
16098099|NCT02177422|Drug|Hydrochlorothiazide|12.5 mg or 25 mg Hydrochlorothiazide in addition to telmisartan in case that the goal response (mean sitting diastolic blood pressure < 90 mmHg) is not met after at least 4 weeks of treatment with telmisartan
16098100|NCT02177409|Drug|Telmisartan|
16098101|NCT02177409|Device|Amlodipine|
16098102|NCT02177409|Drug|Placebo|
16098103|NCT02177396|Drug|Telmisartan|
16098104|NCT02177396|Drug|Valsartan|
16098105|NCT02177396|Drug|Placebo|
16098106|NCT02177383|Dietary Supplement|Docosahexaenoic acid diet supplementation|"Nine soccer players (19 and 22 years old) took 1 liter/day of one experimental beverage (containing 0.2% olive oil + 0.6% DHA-S Martek). Follow-up 8 weeks. At week 8 an acute exercise season was programed.
~One blood sample was taken in resting conditions at beginning of the nutritional intervention (week 0, baseline). Another two blood samples were taken at the end of the nutritional intervention, in resting (week 8, pre-exercise) and post-exercise conditions (week 8, post-exercise). Biochemical measures, oxidative damage markers on lipids, proteins and DNA, antioxidant capabilities (enzyme activities and quantity of enzyme protein and gene expression) and inflammatory markers were measured in serum, plasma, erythrocytes, neutrophils and peripheral blood mononuclear cells."
16098107|NCT02177383|Dietary Supplement|Placebo supplementation|"Six professionals soccer players (19 and 22 years old) took 1 liter/day of placebo beverage (containing 0.8% olive oil). Follow-up 8 weeks. At week 8 an acute exercise season was programed.
~One blood sample was taken in resting conditions at beginning of the nutritional intervention (week 0, baseline). Another two blood samples were taken at the end of the nutritional intervention, in resting (week 8, pre-exercise) and post-exercise conditions (week 8, post-exercise). Biochemical measures, oxidative damage markers on lipids, proteins and DNA, antioxidant capabilities (enzyme activities and quantity of enzyme protein and gene expression) and inflammatory markers were measured in serum, plasma, erythrocytes, neutrophils and peripheral blood mononuclear cells."
16098108|NCT02177370|Drug|Fenoterol MDI|
16098109|NCT02177370|Drug|DSCG MDI|
16098110|NCT02177357|Drug|Pramipexole|
16098111|NCT02177357|Drug|Placebo|
16098112|NCT02177344|Drug|Low dose of Ipratropium bromide|One puff, 4 times daily by oral inhalation
16098113|NCT02177344|Drug|High dose of Ipratropium bromide|One puff, 4 times daily by oral inhalation
16098114|NCT02177344|Drug|Atrovent|Two puffs, 4 times daily by oral inhalation
16098115|NCT02177344|Drug|Placebo|
16098116|NCT02177331|Drug|Lacidipine|
16098117|NCT02177318|Drug|Spiriva (tiotropium bromide) inhalation capsules|Survey of patients with COPD using Spiriva (tiotropium bromide) inhalation capsules
16098118|NCT02177305|Drug|0.02 mcg tiotropium solution|
16098119|NCT02177305|Drug|0.04 mcg tiotropium solution|
16098120|NCT02177305|Drug|0.08 mcg tiotropium solution|
16098121|NCT02177305|Drug|0.16 mcg tiotropium solution|
16098122|NCT02177305|Drug|0.28 mcg tiotropium solution|
16098123|NCT02177305|Drug|0.40 mcg tiotropium solution|
16098124|NCT02177305|Drug|Placebo solution|
16098125|NCT02177292|Radiation|Radiation Therapy|A high dose of radiation to the pelvic lymph nodes of 56 Gy (Gy/Gray = measure of amount of radiation) and at the same time give a boost (additional) radiation to the prostate itself (to 70 Gy).
16098126|NCT02177279|Other|Visit A high wheat bran|
16098127|NCT02177279|Other|Visit B normal wheat bran|
16098128|NCT02177279|Other|Follow up normal (8days) and high (1day) bran consumption|
16098129|NCT02177266|Drug|Colchicine|Colchicine 0.6mg bid will be given to study participants randomized to the study drug arm beginning at 48-72 hours prior to the planned cardiac surgery and then continued for a total of 30 days.
16098130|NCT02177266|Drug|Placebo|The placebo will match the study drug.
16098131|NCT02177253|Drug|Ipratropium bromide / Salbutamol|
16098132|NCT02177253|Drug|Placebo Inhalation solution|
16098133|NCT02177253|Drug|Ipratropium bromide|
16098134|NCT02177253|Drug|COMBIVENT Inhalation Aerosol|
16098135|NCT02177253|Drug|Placebo Inhalation Aerosol|
16098136|NCT02177240|Device|GlideScope® intubation with Flex-it® stylet|GlideScope® intubation with Flex-it® stylet of a simulated difficult airway
16098137|NCT02177240|Device|GlideScope® intubation with GRS® stylet|GlideScope® intubation with GRS® stylet of a simulated difficult airway
16098138|NCT02177227|Device|Attune TruMatch (TM) Patient-Specific Instrumentation|Patients to receive total knee replacement with TruMatch Patient-Specific Instrumentation
16098139|NCT02177214|Procedure|MRI scan|Visualization of the mesh surface observed with MRI scan at 3 weeks and 13 months after ventral hernia repair with a visible IPOM prosthesis (Dynamesh®)
16098140|NCT02177201|Other|Group 1|Intravenous access was established and 10 ml/kg/h 0.9% saline solution was delivered following the induction of anesthesia and until the end of the operation.
16098141|NCT02177201|Other|Group 2|Intravenous access was established and 20 ml/kg/h 0.9% saline solution was delivered following the induction of anesthesia and until the end of the operation.
16098142|NCT02177188|Device|LBNP Lower Bodi Negative Pressure Chamber|
16098143|NCT02177175|Drug|Carvedilol|
16098144|NCT02177175|Other|placebo|
16098145|NCT02177162|Other|Education to physiotherapists|
16098146|NCT02177149|Device|Standard of Care|Patients in the standard of care arm will have their DBS programmed per standard of care which is testing multiple settings and looking for symptom relief through a trial and error process.
16098147|NCT02177149|Device|DBS using Clinical Support System.|The DBS RN (Registered Nurse) will use ImageVis3D Mobile app on the iPad to program the DBS system, this software does not interact with imaging systems. The study team uses identified images provided by the Froedtert PACS system, de identifies them, adds a study code. The images are loaded into the software system and used to identify the leads locations. The Patients will be assessed for 6 months starting with the initial DBS programming session. Importantly, the investigators do not anticipate that the clinical decision support tool will provide the final DBS settings, nor do the investigators anticipate that the approach will obviate the need for motor exams. The clinical decision support system will help nurses choose good initial settings and then explore around those initial settings.
16098148|NCT02177136|Drug|Obeticholic Acid (OCA)|
16098149|NCT02177136|Drug|Placebo|
16098284|NCT02176200|Drug|Berodual® HFA-MDI, high inspiratory flow rate|
16098150|NCT02177123|Device|InnFocus MicroShunt implantation|Implantation will include the use of Mitomycin C applied with sponges.
16098151|NCT02177097|Biological|Blood samples|4 x 10 ml blood samples.
16098152|NCT02177084|Device|PTNS|
16098153|NCT02177071|Drug|INFLIXIMAB|
16098154|NCT02177071|Drug|AZATHIOPRINE|
16098155|NCT02177071|Drug|MERCAPTOPURINE|
16098156|NCT02177071|Drug|Methotrexate|
16098157|NCT02177058|Other|INTERACT Quality improvement program|INTERACT training and implementation between APR 2013 and MAR 2014
16098158|NCT02177058|Other|Quarterly surveys/data reporting|The nursing homes are asked to complete quarterly surveys between APR 2013 to MAR 2014
16098159|NCT02177045|Drug|Sonovue, Bracco|Intravenous injection
16098160|NCT02177032|Biological|Rabies vaccine|"12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) according to the 4-sites, 1-week regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8)."
16098161|NCT02177032|Biological|Rabies vaccines + Rabies immunoglobulins|"12 doses of the PCEC rabies vaccine, administered ID (0.1mL for each injection) to adults only, according to the 4-sites, 1-week regimen (i.e. 4 doses of vaccine; in both deltoids and anterolateral thigh areas, administered on days 1, 4, and 8). HRIG will be administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly into the gluteal muscle."
16098162|NCT02177032|Biological|Rabies vaccine|"8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) according to the 2-sites, TRC, updated Thai Red Cross regimen (i.e. 2 doses of vaccine; in both deltoids, administered on days 1, 4, 8, and 29)."
16098163|NCT02177032|Biological|Rabies vaccines + Rabies immunoglobulins|"8 doses of the PCEC rabies vaccine, administered ID (0.1ml for each injection) to adults only, according to the 2-sites, TRC, updated Thai Red Cross regimen (i.e. 2 doses of vaccine; in both deltoids, administered on days 1, 4, 8, and 29). HRIG will be administered on day 1 (before the first dose of the vaccine) in a dose of 20 IU/kg body weight intramuscularly into the gluteal muscle."
16098164|NCT02177019|Other|Personalized health plan|
16098165|NCT02177006|Behavioral|Sun Protection Program|"The intervention includes two phases:
~Phase 1: From June to August 2014, a voucher to obtain a swim shirt for sun protection provided by the Pediatric Sun Protection Foundation will be affixed to the anticipatory guidance sheet provided by the practice to caregivers of children 2-6 years of age.
~Phase 2: Analysis of online redemption of vouchers in comparison with the self-reported surveys"
16098166|NCT02176980|Behavioral|Brief alcohol counseling|Medical provider gives feedback on how the patient's alcohol use may affect their current and future health, noting that it is the patient's responsibility to change behavior; giving advice to stop drinking based on medical concern; giving a menu of options for cutting down on drinking; expressing empathy; and reinforcing the patient's self-efficacy to change.
16098167|NCT02176980|Behavioral|Group and Individual Therapy Sessions|Session content integrates HCV and alcohol issues in treatment, liver health, and personal realms. Sessions include psychoeducational content on how alcohol affects the liver among people with HCV; HCV stigma; family issues around drinking and the HCV diagnosis; nutrition; life goals and positive affect; and alcohol reduction strategies.
16098175|NCT02176954|Device|Test A|Test A is a new 1-piece ostomy appliance developed by Coloplast A/S
16098176|NCT02176954|Device|Test B|Test B is a new 1-piece ostomy appliance developed by Coloplast A/S
16098177|NCT02176954|Device|Comparator|"Two comparators will be used: Moderma Flex (Hollister) or Confidence Natural drainable (Salts).These product are commercially available.
~Subjects will be randomized into one of twelwe arms. Data will be analyzed by pooling the two comparators, Moderma Flex and Confidence Natural, Drainable, why six arms are displayed."
16098178|NCT02176928|Device|AutoPAP|"PAP will be delivered by an auto-titrating device (IntelliPAP AutoAdjust®). These devices automatically set the level of delivered pressure to ensure upper airway patency, to treat detected apneas and hypopneas.
~AutoPAP treatment 7 nights a week for four months (16 weeks)."
16098179|NCT02176928|Device|Sham PAP|"Sham PAP treatment will be delivered by an auto-PAP device (IntelliPAP AutoAdjust®) that is set to a fixed low pressure of 3 cmH20 without an ability to titrate according to detected respiratory events. The pressure is too low to eliminate respiratory events and serves as sham or sub-therapeutic PAP.
~Sham PAP treatment 7 nights a week for four months (16 weeks)./"
16098180|NCT02176915|Behavioral|Group program|
16098181|NCT02176915|Behavioral|Print Materials|
16098182|NCT02176902|Behavioral|behavioral dietary intervention|Receive dietary counseling
16098183|NCT02176902|Behavioral|behavioral dietary intervention|Receive guidelines for low-fat diet
16098184|NCT02176902|Dietary Supplement|omega-3 fatty acid|Given PO
16098185|NCT02176902|Other|laboratory biomarker analysis|Correlative studies
16098186|NCT02176889|Dietary Supplement|Lactospore|Bacillus coagulans MTCC 5856
16098187|NCT02176889|Other|Placebo|
16098188|NCT02176876|Drug|GS-5745|GS-5745 400 mg administered intravenously
16098189|NCT02176876|Drug|Placebo to match GS-5745|Placebo to match GS-5745 administered intravenously
16098190|NCT02176863|Biological|Flebogamma 5% DIF|Human plasma-derived immunoglobulin
16098191|NCT02176863|Drug|Placebo|Normal saline solution
16098192|NCT02176850|Drug|Micardis®|
16098193|NCT02176837|Drug|Sodium Nitrite|Subjects will receive continuous intravenous infusion of study drug for 7 days at a dose of 64 nmol/min/kg. The infusion will begin shortly after angiographic demonstration of cerebral vasospasm and will be for 7 days unless side effects of the drug dictate stopping the infusion.
16098194|NCT02176824|Behavioral|Total Sleep deprivation, Sleep Phase Advance, and Bright Light Therapy|Sleep deprivation, Sleep phase advance, and Bright light therapy
16098195|NCT02176824|Behavioral|Partial Sleep deprivation, Sleep Phase Delay, and Low amber light.|
16098196|NCT02176824|Other|Treatment as usual|
16098369|NCT02175394|Drug|Microgynon®|
16098197|NCT02176785|Device|transcranial Direct Current Stimulation (tDCS)|tDCS will be delivered using a Chattanooga Ionto™ Iontophoresis System - Phoresor.
16098198|NCT02176772|Other|Stable iron isotopes, non-drug intervention|
16098199|NCT02176759|Other|Administration of rice fortified with regular FePP|
16098200|NCT02176759|Other|Administration of rice fortified with regular FePP with citrate added during extrusion|
16098201|NCT02176759|Other|Administration of rice fortified with regular FePP and citrate added at consumption|
16098202|NCT02176759|Other|Administration of rice fortified with ferrous sulphate|
16098203|NCT02176746|Biological|cancer stem cell vaccine|
16098204|NCT02176733|Drug|cyclosporine|
16098205|NCT02176720|Drug|FDOPA PET|[18F]FDOPA radiopharmaceutical will be intravenousely injected for PET-CT scanning of the brain.
16098206|NCT02176694|Behavioral|Text Messaging|Website that allows adolescents to create, schedule and send one-time or recurring text messages that will serve as a reminder to take asthma medication or follow up with another health-related matter.
16098207|NCT02176681|Drug|Vildagliptin (Galvus)|Use Vildagliptin (50 mg/day) added to insulin during 3 months
16098208|NCT02176681|Drug|Insulin|Insulin
16098209|NCT02176668|Drug|YH4808 NF 100|The number of times : multiple-dose Rout : oral administration
16098210|NCT02176668|Drug|YH4808 OF 200|The number of times : multiple-dose Rout : oral administration
16098211|NCT02176668|Drug|YH4808 NF 200|The number of times : multiple-dose Rout : oral administration
16098212|NCT02176668|Drug|YH4808 NF 400|The number of times : multiple-dose Rout : oral administration
16098213|NCT02176655|Drug|VVD-101|All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.
16098214|NCT02176655|Drug|Placebo|All subjects will treat 6 headaches with either VVD-101 or placebo in a randomized order.
16098215|NCT02176642|Drug|Oxybutynin extended release|5mg tablet taken by mouth daily for 6 weeks
16098216|NCT02176642|Device|Posterior Tibial Nerve Stimulation|In office therapy administered for 30 minutes once every week for a total of 6 weeks
16098217|NCT02176642|Drug|Placebo|Tablet taken by mouth daily for 6 weeks
16098218|NCT02176629|Other|Condition virtual reality (VR) then Condition classic cognitive stimulation (CCS)|
16098219|NCT02176629|Other|Condition classic cognitive stimulation (CCS) then Condition virtual reality (VR)|
16098220|NCT02176616|Procedure|linear ablation|The group of positive control is the operation to add in conventional liner ablation to conventional pulmonary vein isolation with in patients based on patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation
16098221|NCT02176616|Procedure|pulmonary vein isolation|The group of negative is the operation to patients with only pulmonary vein isolation based on patients who were changed to paroxysmal atrial fibrillation from persistent atrial fibrillation
16098222|NCT02176590|Behavioral|Power PATH|PATHS: Teacher-led classroom curriculum promoting a positive classroom environment and teaching social-emotional skills
16098223|NCT02176590|Other|Head Start as usual|Standard Head Start programming (including classroom instruction, meals, and family services)
16098224|NCT02176577|Drug|Product 0405|Product 0405 will be administered topically, twice daily for 28 days.
16098225|NCT02176564|Drug|inhaled bronchodilator|
16098226|NCT02176551|Drug|Product 0405|Product 0405 will be administered topically twice daily for 28 days.
16098227|NCT02176551|Drug|Placebo for Product 0405|Placebo for Product 0405 will be administered topically twice daily for 28 days.
16098228|NCT02176538|Drug|Product 0405|Product 0405 will be administered topically twice daily for 28 days
16098229|NCT02176538|Drug|Placebo for Product 0405|Placebo for Product 0405 will be administered topically twice daily for 28 days.
16098230|NCT02176525|Drug|BI 207127 NA|
16098231|NCT02176525|Drug|Placebo|
16098232|NCT02176512|Drug|BIBR 277 SE and HCTZ|Treatment A - fixed dose combination
16098233|NCT02176512|Drug|BIBR 277 SE|Treatment B - Monocomponent
16098234|NCT02176512|Drug|HCTZ|Treatment B -Monocomponent
16098235|NCT02176499|Drug|Telmisartan, low dose|
16098236|NCT02176499|Drug|Telmisartan, high dose|
16098237|NCT02176499|Drug|Placebo|
16098238|NCT02176486|Drug|Ixazomib|Ixazomib capsules.
16098239|NCT02176486|Drug|Placebo|Ixazomib placebo-matching capsules.
16098240|NCT02176473|Behavioral|Computerized Cognitive Behavioral Therapy|"The c-CBT software focuses on the same principles of traditional CBT, namely, identifying, labeling, and modifying automatic thoughts; the link between thought and action; identifying and modifying schemas; and identifying and correcting cognitive errors.9 C-CBT is delivered in 9 online lessons, each designed to take 30-45 minutes to complete. The software provides modeling of CBT principles (in the form of short videos), enables an interactive forum by giving users feedback based on responses to questions, and encourages participants to employ the skills learned in CBT to their situations. A 9-minute video demonstrating the functionality of Good Days Ahead can be found at: http://www.empower-interactive.com/solutions/good-days-ahead/."
16098241|NCT02176460|Drug|Colchicine|0.5mg twice daily for 16 weeks
16098242|NCT02176460|Drug|Placebo|1 tablet twice daily
16098243|NCT02176434|Procedure|Kidney and hematopoietic stem cell transplantation|Kidney transplantation (day 0) Induction therapy (s. above) Hematopoietic stem cell transplantation (s. above)
16098244|NCT02176434|Biological|hematopoietic stem cell|
16098245|NCT02176421|Device|VOLBELLA® with lidocaine|VOLBELLA® with lidocaine administered to correct skin depression during initial treatment and optional top-up treatment 14 days later.
16098246|NCT02176408|Behavioral|Behavioral Activation|Behavioral Activation Therapy (BA). All participants will receive a standard behavioral activation treatment based on the manualized treatment described by Lejuez et al., 2011. Treatment will be delivered in 60-minute weekly sessions over a 6-week period followed by 3 biweekly booster sessions. Behavioral activation includes scheduling activities the patient will enjoy and find important with the purpose of improving mood.
16098280|NCT02176200|Drug|Berodual® Respimat®, medium inspiratory flow rate|
16098281|NCT02176200|Drug|Berodual® Respimat®, high inspiratory flow rate|
16098282|NCT02176200|Drug|Berodual® HFA-MDI, low inspiratory flow rate|
16098283|NCT02176200|Drug|Berodual® HFA-MDI, medium inspiratory flow rate|
16098370|NCT02175394|Drug|BI 1356|
16098247|NCT02176408|Behavioral|Exercise Intervention|Exercise Intervention (EX). The exercise intervention will immediately follow each of the first six weekly BA sessions. Each EX session will comprise 30 minutes of either providing rationale for the program or reviewing the previous week's progress. As part of the intervention, participants will be asked to perform 40 minutes of aerobic exercise at 60-75% of maximum heart rate on three days each week, with 5 minute stretching warm up and cool down. We will help all participants initiate and plan their at-home program of exercise.
16098248|NCT02176408|Behavioral|Stretching Intervention|Stretching Intervention (STR). The stretching intervention will also follow each of the first six weekly BA sessions. These sessions will comprise 30 minutes of providing rationale for the stretching program or reviewing the previous week's progress. As part of the intervention, participants will be asked to perform 50 minutes of stretching on three days each week. Participants in this condition will be provided with a 50-minute DVD of stretching exercises and will work with the therapist to plan their at-home stretching exercises.
16098249|NCT02176395|Drug|Danhong injection|40ml Danhong injection added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion
16098250|NCT02176395|Procedure|Standard medical care|Standard medical care is in accordance with China Guideline for the diagnosis and treatment of acute ischemic stroke (2010), including medical care for vital signs, control of temperature, blood pressure and glucose, improving cerebral blood circulation, antiplatelet treatment and nutritional supportive care.
16098251|NCT02176395|Drug|placebo|0.9% saline added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion
16098252|NCT02176382|Drug|denosumab|denosumab subcutaneous injection
16098253|NCT02176382|Drug|teriparatide|teriparatide daily subcutaneous injection
16098254|NCT02176382|Drug|Zoledronic acid|zoledronic acid infusion
16098255|NCT02176369|Drug|Vinorelbine|Capsule soft (20/30 mg) - 50 mg three times a week (monday, wednesday and friday) for a three weeks cycle (then recycled the next week at the same doses)Treatment will be continued until progression, unacceptable toxicity or death.
16098256|NCT02176356|Biological|onabotulinumtoxinA|onabotulinumtoxinA (BOTOX® Cosmetic) 20U total dose per treatment to glabellar areas and/or 24U total dose per treatment to crow's feet line areas.
16098257|NCT02176356|Drug|bimatoprost ophthalmic solution 0.03%|bimatoprost ophthalmic solution 0.03% (LATISSE®) 1 drop applied to the upper eyelid at the base of eyelashes once daily in the evening for 17 weeks.
16098258|NCT02176356|Device|JUVÉDERM® ULTRA XC|JUVÉDERM® ULTRA XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.
16098259|NCT02176356|Device|JUVÉDERM® ULTRA PLUS XC|JUVÉDERM® ULTRA PLUS XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.
16098260|NCT02176356|Device|JUVÉDERM® VOLUMA® XC|JUVÉDERM® VOLUMA® XC, a hyaluronic acid gel implant (dermal filler), volume injected determined by the investigator.
16098261|NCT02176343|Device|AcrySof® IQ ReSTOR® +2.5 D Multifocal Toric IOL|Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
16098262|NCT02176330|Other|ePAQ-PF followed by a telephone consultation.|All women randomised to this arm of the study were entered onto the hospital electronic patient record system under the ePAQ clinic. They were were posted an information letter and an epaq-online voucher inviting them to complete the questionnaire on-line. The clinician used these results along with the patient's own casenotes and original referral letter to support the subsequent consultation. The research nurse (HJW) then arranged their telephone consultation. Women in this group who felt unable to complete the questionnaire online would use this telephone call with the research nurse to make arrangements to attend and complete the questionnaire at the hospital.
16098263|NCT02176330|Other|ePAQ-PF followed by a face to face consultation|All women randomised to this arm of the study were posted an appointment to attend the urogynaecology clinic. They were were posted an information letter and an epaq-online voucher inviting them to complete the questionnaire on-line. The clinician used these results along with the patient's own casenotes and original referral letter to support the subsequent consultation. Women then attended for their face to face clinic consultation as normal. Women in this group who felt unable to complete the questionnaire online were given the opportunity to complete the questionnaire at the hospital when they attended for their consultation.
16098264|NCT02176317|Biological|Autologous Umbilical Cord Blood|All participants will receive autologous umbilical cord blood cells with a pre-cryopreservation cell dose of 1-5 x 10^7 Total Nucleated Cells (TNC)/kilogram of subject body weight. The cells will be administered as a single intravenous (into the vein) infusion over 2 to 25 minutes
16098265|NCT02176304|Drug|Depomedrol|Depomedrol 40 mg/ml, 1 ml injected to knee on day one of intervention.
16098266|NCT02176304|Drug|Lidocaine|Lidocaine 2% soln, 4 ml injected to knee on day 1 of intervention
16098267|NCT02176291|Drug|Buprenorphine|low-dose buprenorphine (range 0.2 mg/day -- 2.0 mg/day)
16098268|NCT02176291|Drug|Placebo|matched placebo
16098269|NCT02176278|Other|Telephone Reminder|Nurse will provide telephone contact to patients every 3 month to remind them to adhere to treatment, provide support and empower them to discuss with their doctors about their treatment needs and any concerns
16098270|NCT02176278|Other|Doctor-Nurse Follow Up|Patient will be followed by a doctor-nurse team at least 3 monthly to achieve multiple targets recommended as A1c<7%, BP<130/80 mmHg, LDL-C<1.8 mmol/l, triglyceride<1.7 mmol/l and persistence with RAS inhibitors taking into consideration safety and tolerability (e.g. hypoglycemia, hypotension, changes in electrolytes). Patient report will be given after follow up.
16098271|NCT02176278|Other|Personalized Risk Report for Patient Empowerment|Patients will be given with personalized risk reports after baseline and 12-month repeat comprehensive assessments.
16098272|NCT02176265|Device|Qvanteq bioactive coronary stent|PCI
16098273|NCT02176252|Drug|AZD1722|
16098274|NCT02176252|Drug|Placebo|
16098275|NCT02176226|Behavioral|IntelliCare|Behavioral interventions for depression and anxiety via a mobile phone application, IntelliCare.
16098276|NCT02176213|Drug|Pomalidomide|4 mg PO x 21 days
16098277|NCT02176213|Drug|Cyclophosphamide|low dose cyclophosphamide 50 mg PO BID x 21 days
16098278|NCT02176213|Drug|Dexamethasone|dexamethasone 40 mg PO weekly (or 20 mg if ≥ 75 years old).
16098285|NCT02176187|Drug|Berodual® Respimat® inhaler|fenoterol hydrobromide 50μg + ipratropium bromide 20μg
16098286|NCT02176187|Drug|Berodual® metered dose inhaler|fenoterol hydrobromide 50μg + ipratropium bromide 20μg
16098287|NCT02176161|Drug|Metformin Hydrochloride Extended Release 750mg|Metformin Hydrochloride Extended Release 750mg twice per day for 9 months.
16098288|NCT02176148|Drug|fluocinonide 0.05% cream|
16098289|NCT02176135|Drug|Auranofin|3 mg tablets
16098290|NCT02176122|Drug|Meropenem|Meropenem is a carbapenem anti-bacterial used for the treatment of serious infections in patients.
16098291|NCT02176122|Drug|Piperacillin-tazobactam combination product|Piperacillin-tazobactam is used for the treatment of patients with systemic and/or local bacterial infections.
16098292|NCT02176096|Dietary Supplement|Glycosade|
16098293|NCT02176083|Behavioral|Text message management prompts|
16098294|NCT02176057|Drug|Azithromycin|
16098295|NCT02176044|Drug|Sodium Nitroprusside infusion|
16098296|NCT02176044|Other|Placebo|
16098297|NCT02176031|Drug|Natalizumab|
16098298|NCT02176031|Drug|Methylprednisolone|
16098299|NCT02176018|Drug|Dextromethorphan and quinidine|
16098300|NCT02176018|Drug|Placebo|
16098301|NCT02176005|Device|DAV132|DAV132 is associated to moxifloxacin or it is evaluated alone
16098302|NCT02176005|Drug|Moxifloxacin|Moxifloxacin is used alone or associated to DAV132
16098303|NCT02176005|Other|Negative Control|Moxifloxacin is used alone
16098304|NCT02175979|Dietary Supplement|enriched enteral nutrition|enriched enteral tube feeding perioperative
16098305|NCT02175979|Dietary Supplement|standard|standard of care
16098306|NCT02175966|Drug|DCV/ASV/BMS-791325|
16098307|NCT02175966|Drug|Ribavirin|
16098308|NCT02175966|Drug|Sofosbuvir|
16098309|NCT02175966|Drug|Peginterferon α-2a|
16098310|NCT02175953|Behavioral|Psychotherapy|The program is designed for 10 participants and consists of two modules of caregiver education followed by ten psychotherapeutic group modules. The major overarching topics will be (i) caregiver´s emotional and physical limits, (ii) conscious and unconscious feelings and emotions towards the people with dementia and (iii) activation of caregivers´ social resources. Duration of each module is planned to be 90 minutes including a relaxation exercise at the end of each module.
16098311|NCT02175927|Drug|Lansoprazole|antisecretory drug of each quadruple therapy
16098312|NCT02175927|Drug|Bismuth Potassium Citrate|one component of each quadruple therapy
16098313|NCT02175927|Drug|Metronidazole|antibiotic of each quadruple therapy
16098314|NCT02175927|Drug|Amoxicillin|antibiotic of high dose amoxicillin based quadruple therapy
16098315|NCT02175927|Drug|Tetracycline|antibiotic of classical quadruple therapy
16098316|NCT02175914|Drug|Erythromycin|Oral Treatment with Erythromycin 500mg, twice daily, for 12 weeks
16098317|NCT02175901|Drug|Lansoprazole|antisecretory drug of each quadruple therapy
16098318|NCT02175901|Drug|Bismuth Potassium Citrate|one component of each quadruple therapy
16098319|NCT02175901|Drug|Amoxicillin|antibiotic of each quadruple therapy
16098320|NCT02175901|Drug|Metronidazole|antibiotic of the amoxicillin/metronidazole-based quadruple therapy
16098321|NCT02175901|Drug|Clarithromycin|antibiotic of the amoxicillin/clarithromycin-based quadruple therapy
16098322|NCT02175888|Dietary Supplement|Daily administration of 60 mg iron in form of ferrous sulphate capsules for 14 consecutive days|
16098323|NCT02175888|Dietary Supplement|Administrations of 60 mg iron in form of ferrous sulphate capsules on every second day for 28 days|
16098324|NCT02175797|Device|MRI|at least 6 weeks after the implantation of the pacemaker a MRI exam is performed
16098325|NCT02175784|Drug|ipragliflozin|oral
16098326|NCT02175784|Drug|placebo|oral
16098327|NCT02175771|Drug|Fp MDPI|"Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate dispersed in a lactose monohydrate excipient.
~During the treatment period, participants were randomized to either 100 mcg or 200 mcg of Fp one inhalation twice a day for a total daily dose of 200 mcg or 400 mcg. Study drug was administered in the morning and in the evening."
16098328|NCT02175771|Drug|FS MDPI|"FS MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) and salmeterol xinafoate (Sx) dispersed in a lactose monohydrate excipient.
~During the treatment period, participants were randomized to either Fp/Sx MDPI 100/12.5 mcg or Fp/Sx MDPI 100/12.5 mcg twice a day for a total daily dose of 200/25 mcg or 400/25 mcg Fp/Sx. Study drug was administered in the morning and in the evening."
16098329|NCT02175771|Drug|FLOVENT HFA|"FLOVENT HFA is a hydrofluoroalkane (HFA) inhaler containing fluticasone propionate.
~During the treatment period, participants were randomized to either 110 mcg or 220 mcg of FLOVENT two puffs, twice a day for a total daily dose of 440 mcg or 880 mcg. Study drug was administered in the morning and in the evening."
16098330|NCT02175771|Drug|ADVAIR DISKUS|"ADVAIR DISKUS contains a dry powder formulation of fluticasone propionate (Fp) and salmeterol xinafoate (Sx) in a lactose excipient.
~During the treatment period, participants were randomized to Fp 250 mcg/Sx 50 mcg or Fp 500 mcg/Sx 50 mcg one inhalation, twice a day for a total daily dose of 500/100 mcg or 1000/100 mcg. Study drug was administered in the morning and in the evening."
16098331|NCT02175771|Drug|albuterol/salbutamol HFA|A short-acting β2-adrenergic agonists (SABA), albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI), was provided to be used as needed for the relief of asthma symptoms during both the run-in and treatment periods (to replace the subject's current rescue medication).
16098332|NCT02175758|Drug|SOF|SOF administered orally once daily
16098333|NCT02175758|Drug|RBV|RBV oral solution or capsules will be administered orally in a divided daily dose based on weight
16098334|NCT02175745|Drug|18F-fluoro-dihydroxyphenylalanine|Administered intravenously (IV)
16098335|NCT02175745|Procedure|Positron emission tomography (PET)|Component of an 18F-FDOPA PET/CT or PET/MRI scan
16098336|NCT02175745|Procedure|Computed tomography (CT)|Component of an 18F-FDOPA PET/CT
16098337|NCT02175745|Procedure|Magnetic resonance imaging|Component of an 18F-FDOPA PET/MRI
16098371|NCT02175381|Drug|Carboplatin|Carboplatin: 2.5 AUC i.v on day 1. Cycle repeated ever 2 weeks
16098372|NCT02175381|Drug|Gemcitabine|Gemcitabine: 1100 mg/m2, iv on day 1. Cycle repeated every 2 weeks
16098373|NCT02175368|Device|Adhese One F Upgrade|
16098338|NCT02175732|Behavioral|'KnowIt'|"Participants in the 'KnowIt' group will participate in a single, day-long group workshop led by a trained facilitator. Content covered during the program will focus on recent advances in diabetes care and self-management.
~During the three months following the initial workshop, participants will receive four telephone calls with their group facilitator to address any questions and challenges. One week after each phone call participants will take part in a 60 minute web meetings with their facilitator and other group members to review program content and discuss any challenges. Finally, participants will receive two further phone calls from their facilitator during months four to nine."
16098339|NCT02175732|Behavioral|'OnTrack'|"Participants in the 'OnTrack' group will participate in a single, day-long group workshop led by a trained facilitator. Content covered during the program will utilize an emotion-based adaptation of Problem Solving Therapy to target and reduce diabetes distress.
~During the three months following the initial workshop, participants will receive four telephone calls with their group facilitator to address any questions and challenges. One week after each phone call participants will take part in a 60 minute web meetings with their facilitator and other group members to review program content and discuss any challenges. Finally, participants will receive two further phone calls from their facilitator during months four to nine."
16098340|NCT02175706|Device|Resolute Integrity®|Biolinx-zotarolimus coating on a chobalt-cromium alloy stent platform that has a novel sinusoidal design.
16098341|NCT02175706|Device|Promus Element®|fluoropolymer-everolimus coating on a novel stent platform made from a platinum-chromium alloy
16098342|NCT02175680|Drug|PRO 140 350mg weekly SQ injection.|CCR5 Antagonist
16098343|NCT02175667|Procedure|Global Postural Reeducation|Experimental group is treated in a 45 minutes GPR session, with three postures: the first was for the anterior muscular chain with the patient lying supine on a couch with arms at 45 degrees, hips open, and feet in opposition on top of the table. This posture is maintained 25-30 minutes. The second GPR posture, to stretch the posterior muscle chain, the participant is positioned with legs elevated, for 12-15 minutes. Third position is with the participant standing and 2-5 minutes to integrate the postural corrections. During all the time, the physiotherapist use manual therapy for stretch the muscles under the official rules of GPR techniques. Group control do not receive any technique.
16098344|NCT02175654|Drug|Regorafenib|
16098345|NCT02175641|Behavioral|Peer-Led Group Lifestyle Balance|The intervention follows the Group Lifestyle Balance curriculum derived from the Diabetes Prevention Program and The intervention will be delivered by trained peer-specialists employed at the supportive housing agencies and supervised by the study team. Peer GLB is a 12-month group intervention that focuses helping people lose weight by improving people's diet and increasing their physical activity and consists of weekly core group sessions (3 mo.), bi-monthly transitional group sessions (3 mo.), and maintenance monthly sessions (6 mo.).
16098346|NCT02175641|Behavioral|Usual Care Services|The usual care condition encompasses the regular services offered at supportive housing agencies to help clients with their physical health and wellness.
16098347|NCT02175628|Device|Acoustic Angiography|"Acoustic angiography imaging involves a research high frequency ultrasound scanner (VisualSonics Vevo 770) and a prototype transducer as well as conventional b-mode ultrasound to guide the location of the imaging. The conventional ultrasound will be conducted just prior to the acoustic angiography for localization. The imaging also requires administration of Definity ultrasound contrast agent.
~Acoustic angiography imaging will be performed by trained medical personnel using mild compression to eliminate motion. Total imaging time is estimated to be less than 15 minutes. All image data will be de-identified and transferred for off-line analysis based on a study ID. The research images will NOT be interpreted or analyzed for clinical decisions related to the patient."
16098348|NCT02175602|Drug|Escitalopram|10 milligrams administered each morning
16098349|NCT02175602|Drug|Sertraline|50 milligrams administered each morning
16098350|NCT02175602|Drug|DCV 3DAA FDC|Fixed dose combination (daclatasvir [DCV] 30 milligrams, asunaprevir [ASV] 200 milligrams, and BMS-791325 75 milligrams) one tablet administered twice daily
16098351|NCT02175602|Drug|BMS-791325|75 milligrams single-agent film coated oral tablet administered twice daily
16098352|NCT02175589|Other|Colchicine Cessation|Colchicine Cessation
16098353|NCT02175576|Device|Vanguard XP Bicruciate Knee System|The Vanguard XP is a bicruciate retaining total knee design and is constrained by natural soft tissue.
16098354|NCT02175576|Device|Vanguard CR Knee System|The Vanguard CR system requires the ACL to be sacrificed and is constrained by soft tissue and device design.
16098355|NCT02175563|Device|Audiovisual feedback from smartphone based app|
16098356|NCT02175550|Device|NR CC|
16098357|NCT02175537|Behavioral|Microclinic Social Induction Diabetes and Obesity Program|Microclinics consist of 2-8 individuals from pre-existing social networks (friends, relatives, coworkers, neighbors, etc) that voluntarily participate in ongoing education and medical monitoring from local health care professionals, learning and practicing diabetes management strategies, sharing much-needed medical supplies, and exchanging social support.
16098358|NCT02175511|Device|Cloud-based home BP monitoring|"a sphygmomanometer-style BP measurement device (Microlife®, WatchBP Home) that stored and transmitted data to a secure cloud BP system directly via a General Packet Radio Service (GPRS) gateway through cell phone network."
16098359|NCT02175498|Drug|Homoeopathic medicines|4 pills once a week of the indicated Similimum
16098360|NCT02175485|Drug|Fexofenadine HCl 30 mg+Pseudophedrine HCl 60 mg|Pharmaceutical form:tablet Route of administration: oral
16098361|NCT02175472|Device|Spectramax light therapy device|Spectramax light therapy device emits a specific combination of bandwidths and intensities of light.
16098362|NCT02175472|Device|Control light device|The control light device is identical in appearance to the Spectramax light therapy device, except that when turned on, emits a different combination of bandwidths and intensity, not believed to produce a therapeutic response.
16098363|NCT02175446|Drug|Bevacizumab and eribulin|"In this study, Bevacizumab and Eribulin are considered to be the investigational study drugs. Bevacizumab is provided as 25 mg/ml concentrate for infusion. Vials contain 100 mg of Bevacizumab in 4 ml and/or 400 mg in 16 ml. Eribulin is provided as vials containing 1 mg/2 mL Eribulin as a 500 µg/mL solution in ethanol/water"
16098364|NCT02175433|Drug|AGS67E|intravenous (IV) infusion
16098365|NCT02175420|Biological|BCG|
16098366|NCT02175420|Biological|TFV|
16098367|NCT02175407|Drug|ASP1707|oral
16098368|NCT02175407|Drug|itraconazole|oral
16098374|NCT02175355|Drug|Low dose of Micardis®|
16098375|NCT02175355|Drug|Medium dose of Micardis®|
16098376|NCT02175355|Drug|High dose of Micardis®|
16098377|NCT02175355|Drug|Hydrochlorothiazide|
16098378|NCT02175355|Drug|Placebo|
16098379|NCT02175342|Drug|Tiotropium 0.625 mcg/puff|
16098380|NCT02175342|Drug|Tiotropium 1.25 mcg/puff|
16098381|NCT02175342|Drug|Tiotropium 2.5 mcg/puff|
16098382|NCT02175342|Drug|Tiotropium 5 mcg/puff|
16098383|NCT02175342|Drug|Placebo solution|
16098384|NCT02175342|Drug|Tiotropium-18 lactose powder|
16098385|NCT02175342|Drug|Placebo lactose powder|
16098386|NCT02175342|Drug|Tiotropium 10 mcg/puff|
16098387|NCT02175342|Device|Respimat|
16098388|NCT02175342|Device|Handihaler|
16098389|NCT02175329|Device|CAD/CAM Veneering|CAD/CAM fabricated zirconia bridge framework is veneered with CAD/CAM fabricated lithium disilicate ceramic veneer
16098390|NCT02175329|Device|Manually layered veneering|
16098391|NCT02175316|Device|Enhanced External Counterpulsation|Enhanced External Counterpulsation
16098392|NCT02175303|Biological|Decidual stromal cell therapy|Decidual stromal cells from placenta will be infused intravenously at approximately 1x10^6 cells/kg at one or more occasions at weekly intervals.
16098393|NCT02175277|Drug|Darbepoetin Alfa|The first dose of darbepoetin alfa was the same as that administered at the last dosing visit of the active treatment period in Study 20090160. Doses could be increased up to a maximum of 500 μg every two weeks (Q2W).
16098394|NCT02175264|Genetic|Blood sample|
16098395|NCT02175251|Procedure|high frequency (20Hz)|10 session in 5 days with high frequency (20 Hz)
16098396|NCT02175251|Procedure|low frequency (1Hz)|10 session in 5 days with low frequency (1Hz)
16098397|NCT02175251|Procedure|Sham Comparator|10 session in 5 days with sham-controlled
16098398|NCT02175238|Drug|BI 691751 fasted|single dose BI 691751 in fasted state
16098399|NCT02175238|Drug|BI 691751 after high fat breakfast|single dose BI 691751 after a standardised high fat breakfast
16098400|NCT02175225|Drug|Deferoxamine Mesylate|
16098401|NCT02175225|Drug|Placebo (for Deferoxamine Mesylate)|
16098402|NCT02175212|Drug|Short term androgen deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
~Bicalutamide 50 mg tablet every day for 2 months"
16098403|NCT02175212|Drug|Long term androgen deprivation|"Gosereline 3.6 mg 1 month plus 10.8 mg subcutaneously 3 months (total 4 months)
~Bicalutamide 50 mg tablet every day for 2 months
~Gosereline 10.8 mg by subcutaneous injection every 3 moths for 2 years at the end of the radiotherapy"
16098404|NCT02175212|Radiation|Short term androgen deprivation|Minimum dose of 76 Gy (range 76-82 Gy)
16098405|NCT02175212|Radiation|Long term androgen deprivation|Minimum dose of 76 Gy (range 76-82 Gy)
16098406|NCT02175199|Device|Lotrafilcon B contact lenses with color printing|
16098407|NCT02175199|Device|Phemfilcon A contact lenses with color printing|
16098408|NCT02175186|Drug|ALBIS|
16098409|NCT02175186|Drug|Placebo|
16098410|NCT02175173|Drug|Rufinamide|Administration of Inoveron 100mg or 200mg Tablets
16098411|NCT02175160|Other|Braking and functionality|
16098412|NCT02175134|Other|Blood and Ascites ELISPOT|
16098413|NCT02175121|Drug|Placebo|Tablet, once daily for 28 days
16098414|NCT02175121|Drug|PF-06291874|Tablet, 15 mg, once daily for 28 days
16098415|NCT02175121|Drug|PF-06291874|Tablet, 35 mg, once daily for 28 days
16098416|NCT02175121|Drug|PF-06291874|Tablet, 75 mg, once daily for 28 days
16098417|NCT02175121|Drug|PF-06291874|Tablet, 150 mg, once daily for 28 days
16098418|NCT02175095|Drug|Regorafenib|After checking the eligibility for the study entry, patients will be scheduled to perform [18F]FLT-PET scans before and on 21st day from the administration of regorafenib. Regorafenib will be administered 160 mg/day given orally on day 1 to days 21 following 7 days break, which consists of 4 weeks as 1 cycle. Treatment will be repeated every 4 weeks and continued until disease progression, unacceptable toxicity or the patient's refusal. Standard anatomical response evaluation will be performed every 8 weeks (without regard to the cycles or schedules of chemotherapy).
16098419|NCT02175082|Other|Cycling at Forced rate|
16098420|NCT02175082|Other|Cycling at self-selected rate|
16098421|NCT02175069|Procedure|Interscalene Nerve Block|ultrasound guided interscalene plexus block (UISB) immediately before magnetic resonance imaging of the neck.
16098422|NCT02175069|Drug|Ropivacaine 0.75%, 20ml|20 ml of ropivacaine 0.75%
16098423|NCT02175069|Drug|Gadopentetate-Dimeglumine 0.0125 mmol|0.0125 mmol of gadopentetate-dimeglumine
16098424|NCT02175069|Drug|Gadopentetate-Dimeglumine 0.05 mmol|0.05 mmol of gadopentetate-dimeglumine
16098425|NCT02175069|Drug|Ropivacaine 0.75%, 5ml|5 ml of ropivacaine 0.75%
16098426|NCT02175069|Procedure|Shoulder Surgery|As per individual requirement (patient-dependent)
16098427|NCT02175056|Biological|HL2351|Dose-escalation For 5 level dose groups A ~ E(each 1, 2, 4, 8, 12mg/kg), 10 subjects (8 for the study drug and 2 for placebo) are randomized to each dose group, and the study drug or placebo is subcutaneously administered for the relevant dose group.
16098428|NCT02175056|Biological|Kineret(Anakinra)|Active comparator(group F) is implemented in parallel with dose groups A~E in an open-label manner and 8 subjects subcutaneously administer Kineret® 100 mg.
16098429|NCT02175043|Procedure|atrial electrogram and liner ablation|"The group of positive control is the operation to add in CFAE to conventional liner ablation in persistent atrial fibrillation patients
~The group of negative is the operation to only doing conventional liner ablation with persistent atrial fibrillation"
16098430|NCT02175030|Drug|Copper IUD|Randomization to copper/Paragard IUD for emergency contraception
16098431|NCT02175030|Drug|Levonorgestrel IUD|Randomization to Levonorgestrel/Mirena IUD for emergency contraception
16098432|NCT02175017|Drug|ONO-4538|
16098433|NCT02175004|Drug|IONIS-TTR Rx|300 mg IONIS-TTR Rx administered once weekly
16098434|NCT02174991|Drug|Rho-Kinase Inhibitor (AR-12286)|
16098435|NCT02174978|Biological|FMP012 with AS01B adjuvant system|Candidate malaria vaccine based on the recombinant protein FMP012, which is Escherichia coli-expressed Plasmodium falciparum cell-traversal protein for ookinetes and sporozoites (PfCelTOS)
16098436|NCT02174978|Other|P falciparum Controlled Human Malaria Infection (CHMI)|
16098437|NCT02174965|Device|MiniHip (Corin U.K.)|MiniHip (Corin U.K.) femoral component
16098438|NCT02174965|Device|Metafix (Corin, U.K)|Metafix (Corin, U.K) conventional cementless stem
16098439|NCT02174952|Behavioral|Self-help version of the New Forest Parenting Programme|
16098440|NCT02174939|Drug|Cilostazol|One tablet (100 mg) twice per day for 12 weeks
16098441|NCT02174939|Drug|Dummy Placebo|One tablet twice per day for 12 weeks
16098442|NCT02174926|Procedure|Elective laparoscopic sigmoid resection|
16098443|NCT02174926|Dietary Supplement|Conservative treatment|Written lifestyle guidance and fiber supplements
16098444|NCT02174913|Device|bispectral index|Bispectral index (BIS) is one of several technologies used to monitor depth of anesthesia.
16098445|NCT02174913|Drug|Target controlled infusion of propofol|TCI propofol (3-7 mcg/dL, Schnider model) is used for total intravenous anesthesia in both groups
16098446|NCT02174913|Drug|Fentanyl|Fentanyl 1-2 mcg/kg iv for induction and then 0.5-1.0 mcg/kg/hr infusion is used for analgesic.
16098447|NCT02174913|Drug|Atracurium|Atracurium 0.6 mg/kg is used for endotracheal intubation
16098448|NCT02174900|Drug|Artemether-Lumefantrine (AL) + 0.25 mg/kg primaquine|
16098449|NCT02174900|Drug|Artemether-Lumefantrine (AL) combination|
16098450|NCT02174900|Drug|Artemether-Lumefantrine (AL) + 0.4 mg/kg primaquine|
16098451|NCT02174887|Drug|Nab-paclitaxel + Gemcitabine|"Gemcitabine 1 g/m² IV infusion over 30 minutes at D1-D8-D15 every 28 days in combination with Nab-paclitaxel 125 mg/m² IV infusion over 30 minutes at D1-D8-D15 every 28 days
~The patients will receive 2 cycles of treatment every 28 days:"
16098452|NCT02174861|Drug|Erenumab|Administered by subcutaneous injection once a month
16098453|NCT02174848|Drug|Deferiprone oral solution|Deferiprone oral solution at a dosage of up to 15 mg per kilogram of body weight, twice a day
16098454|NCT02174835|Drug|AVP-786|
16098455|NCT02174835|Drug|AVP-923|
16098456|NCT02174822|Drug|AVP-786|
16098457|NCT02174822|Drug|Paroxetine|
16098458|NCT02174822|Drug|Duloxetine|
16098459|NCT02174809|Behavioral|Use of 5As to discuss gestational weight gain|
16098460|NCT02174809|Behavioral|Usual care|
16098461|NCT02174796|Procedure|surgical treatment|patients who chose to undergo a surgical correction (Ravitch or Nuss type intervention).
16098462|NCT02174796|Procedure|orthopedic treatment|orthopedic treatment by vacuum bell.
16098463|NCT02174783|Other|Control group|Patient will be provided with basic nutrition educational materials that outline principles of a healthy diet, including: moderation, portion control, increased intakes of fruits, vegetables and whole grains and reduced intakes of saturated fat, salt and sugar. Brief education will be provided by the hepatologist without dietitian referral.
16098464|NCT02174783|Other|Mediterranean diet|Patient will receive verbal diet instruction from the dietitian or from the hepatologist who has received instruction from the dietitian on following the Mediterranean diet.
16098465|NCT02174783|Other|Protein-Sparing Modified Fast (PSMF)|"Patient will be referred to the dietitian for an appointment to discuss the PSMF plan.
~Protein needs of 1.5 grams/kilogram will be calculated based on patient's actual body weight.
~Patient will receive verbal instruction from the dietitian, as well as printed materials for reference at home. Dietitian will provide a list of allowed and prohibited foods as per Cleveland Clinic's PSMF diet standards."
16098466|NCT02174770|Other|Blood Flow Restriction (BFR) Training|This is a modality of physical therapy where during low-load resistance activity, the venous return of blood from an extremity is limited only during the duration of the exercise. This can be accomplished through multiple means. For the purposes of our study, we will use an inflatable tourniquet.
16098467|NCT02174770|Other|Standard ACSM-guided strength training|This is the standard protocol to be used for post-operative and other physical therapy patients for rehabilitation. It includes the use of American College of Sports Medicine-guidelines for how much weight to use during the strength training portion of the rehabilitation.
16098468|NCT02174757|Drug|Inersan|Probiotic
16098469|NCT02174757|Drug|Doxycycline|Antibiotic
16098470|NCT02174744|Other|numeric pain rating scale|
16098471|NCT02174731|Drug|Roxadustat|Roxadustat will be administered orally three times a week (TIW) to achieve an Hb level of 11 g/dL and maintain a Hb level of 11±1 g/dL.
16098472|NCT02174731|Drug|Epoetin alfa|Epoetin alfa will be administered TIW consistent with approved prescribing information for epoetin alfa to achieve an Hb level of 11 g/dL and maintain a Hb level of 11±1 g/dL.
16098473|NCT02174718|Dietary Supplement|Transdermal D Patch|
16098474|NCT02174718|Dietary Supplement|Oral vitamin D3|
16098475|NCT02174718|Dietary Supplement|Placebo patch|
16098476|NCT02174718|Dietary Supplement|Oral placebo|
16098477|NCT02174705|Drug|Sucrose|Sucrose 24% orally prior to vaccine injections
16098478|NCT02174705|Drug|Rotavirus|Rotavirus vaccine orally prior to vaccine injections
16098479|NCT02174692|Other|Exercise|"One leg eccentric exercise: 7 sets of 10 repetitions at 80% 1 repetition maximum Contralateral leg concentric exercise: 7 sets of 10 repetitions at 80% 1 repetition maximum
~2 mins rest between sets"
16098480|NCT02174679|Drug|68Ga DOTATATE|Patients with somatostatin receptor positive tumors will be evaluated with 68Ga-DOTATATE PET/CT.
16098481|NCT02174666|Dietary Supplement|Red clover extract|Aglycone isoflavones 80mg/d
16098482|NCT02174666|Dietary Supplement|Supplementation (placebo)|
16098483|NCT02174653|Drug|EPs® 7630|20 mg EPs® 7630 film-coated tablets during 4 months Orally intake three times a day (in the morning, midday and evening)
16098484|NCT02174653|Drug|Placebo|Control: Placebo film coated tablets during 4 months Orally intake three times a day (in the morning, midday and evening)
16098485|NCT02174640|Dietary Supplement|Coffee|Coffee Beverage
16098486|NCT02174640|Dietary Supplement|Water|Water
16098487|NCT02174627|Drug|Roxadustat|The initial study drug dose is 70 mg three times a week (TIW). The dose is subsequently adjusted to achieve and maintain Hb 11±1 g/dL.
16098488|NCT02174627|Drug|Placebo|The initial study drug dose is 70 mg three times a week (TIW). The dose is subsequently adjusted to achieve and maintain Hb 11±1 g/dL.
16098569|NCT02173977|Other|ARM B- Antagonist protocol|In vitro fertilization (IVF/ICSI)
16098489|NCT02174614|Behavioral|Treatment As Usual (TAU)|Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time.
16098490|NCT02174614|Behavioral|TAU plus Rapid Abstinence Initiation (RAI)|Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time PLUS the chance to earn money for urine specimens that are negative for cocaine during the first 4 weeks of treatment followed by 8 weeks of CBT4CBT computerized therapy.
16098491|NCT02174614|Behavioral|TAU plus RAI plus Cognitive Control Training (CCT)|Treatment normally offered at this clinic which could include individual or group drug counseling sessions three times per week lasting three hours each time PLUS the chance to earn money for urine specimens that are negative for cocaine during the first 4 weeks of treatment PLUS sessions of computerized cognitive control training (CCT) 3 times per week for the first 4 weeks followed by 8 weeks of CBT4CBT computerized therapy.
16098492|NCT02174588|Drug|Midazolam + propofol|Midazolam and propofol are used for sedation drug. Balanced propofol sedation (BPS) refers to the administration of an opiate, a benzodiazepine, and propofol.
16098493|NCT02174588|Drug|propofol|propofol are used for sedation drug
16098494|NCT02174575|Drug|Sevoflurane|Sevoflurane is administered during anesthesia in Sevoflurane group.
16098495|NCT02174575|Drug|Desflurane|Desflurane is administered during anesthesia in Desflurane group.
16098496|NCT02174562|Behavioral|Primary Care-Occupational Therapy|PC-OT consists of: 1) primary care physician (PCP) - occupational therapist (OT) collaboration; 2) DM education tailored to cognitive impairment; 3) in-home OT cognitive-functional assessment; and 4) OT-delivered Behavior Activation to increase adherence to medications and other diabetes self-management (DSM) practices (e.g., diet).
16098497|NCT02174562|Behavioral|Enhanced Usual Care|Usual care enhanced with education and attention
16098498|NCT02174549|Drug|Tirapazamine|Intra-arterial injection into the tumor feeding artery
16098499|NCT02174549|Procedure|Transarterial embolization (TAE)|Lipiodol and Gelfoam used to embolize tumor vessels and induce tumor hypoxia
16098500|NCT02174536|Biological|Decidual stromal cells|Decidual stromal cells (approximately 1x10^6 cells/kg) will be infused intravenously.
16098501|NCT02174536|Biological|Placebo|
16098502|NCT02174523|Drug|40mg lurasidone|
16098503|NCT02174523|Drug|placebo|
16098504|NCT02174510|Drug|20mg lurasidone|single oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1.
16098505|NCT02174510|Drug|40mg lurasidone|single oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1.
16098506|NCT02174510|Drug|80mg lurasidone|single oral lurasidone or placebo in 30 minutes after beginning of the over 350 kcal breakfast on day 1.
16098507|NCT02174510|Drug|placebo|
16098508|NCT02174458|Procedure|Body Contouring Surgery|Patients after bariatric surgery (BS) and patients with no history of BS but after natural weight loss and some degree of skin laxity who underwent Body contouring will be included after written informed consent is obtained.
16098509|NCT02174445|Drug|Imatinib|Imatinib, 400 to 800 mg p.o., daily
16098510|NCT02174445|Drug|Nilotinib|300mg p.o., twice-daily
16098511|NCT02174432|Drug|nalbuphine HCl ER|nalbuphine HCl ER BID for up to 50 weeks
16098512|NCT02174419|Drug|nalbuphine HCl ER tablets 90 mg BID|nalbuphine HCl ER tablets 90 mg BID administered for 8 weeks
16098513|NCT02174419|Drug|nalbuphine HCl ER tablets 180 mg BID|nalbuphine HCl ER tablets 180 mg BID administered for 8 weeks
16098514|NCT02174419|Drug|Placebo tablets BID|Placebo tablets BID administered for 10 weeks
16098515|NCT02174406|Procedure|breast ultrasound|
16098516|NCT02174406|Procedure|DBT (Full field digital mammography + tomosynthesis)|
16098517|NCT02174393|Drug|Universal Peel|Universal Peel: is a chemical peel consisting of a mild acid solution. (5 min Peel and 5 min Retinol)
16098518|NCT02174393|Procedure|Microneedling|"Microneedling: is a device for all skin types that creates micro injuries in the dermis (layer of the skin underneath the outermost layer) in an attempt to trigger new collagen (natural component of skin tissue) production for smoother, firmer and younger-looking skin.
~For this protocol, the needle depth will be increased over the 3 sessions:
~Forehead: 0.75 mm, 0.85 mm, 1.0 mm. Cheeks/Chin: 1.0 mm, 1.5 mm, 2.0 mm.
~Each Session: Microneedling procedure on Day 1, followed by skin care regimen"
16098519|NCT02174393|Drug|Post-Microneedling Skin Care|"On Day 1 (after Microneedling procedure):
~Gentle Antioxidant Soothing Cleanser daily
~Soothing Recovery Ointment and Sheer Physical Sunscreen
~On Day 2-7:
~AM: Physical sheer sunscreen and recovery ointment
~PM: Retinol/Vitamin C in the evening and soothing recovery ointment
~On Day 7:
~AM: BD Hydrating Day/Night Cream
~PM: Retinol and Vitamin C and the BD Hydrating Day/Night Cream (if necessary)"
16098520|NCT02174393|Drug|Post-Universal Peel Skin Care|"Gentle Antioxidant Soothing Cleanser daily
~Physical Sunscreen daily
~Soothing recovery ointment fortified with silver only when peeling occurs
~After completely peeling, vitamin c product in the morning and the retinol in the evening"
16098521|NCT02174380|Other|Active Household Contact Evaluation|Active evaluation of TB household contacts will be introducted as a new intervention in the district. The intervention will be undertaken by routine public health staff under routine conditions, however the assignment, training, monitoring and supervision of this intervention will occur in a stepped wedge roll out.
16098522|NCT02174367|Device|Transient elastography|a noninvasive tool for measuring liver stiffness as a predictor of liver fibrosis
16098523|NCT02174328|Drug|Acetylsalicylic acid|Acetylsalicylic acid once a day until 36 week
16098524|NCT02174328|Drug|Placebo|Placebo once a day until 36 week
16098525|NCT02174315|Behavioral|Contingency Management|
16098526|NCT02174289|Device|Targeted left ventricular endocardial lead placement|The left ventricular endocardial lead will be passed through the intra-atrial septum
16098527|NCT02174276|Drug|Tenofovir disoproxil fumarate|TDF 300 mg tablet administered orally once daily
16098528|NCT02174276|Biological|GS-4774|GS-4774 subcutaneous injection administered every 4 weeks for a total of 6 doses
16098529|NCT02174263|Biological|tocilizumab|Given IV
16098530|NCT02174263|Other|laboratory biomarker analysis|Correlative studies
16098531|NCT02174263|Other|quality-of-life assessment|Ancillary studies
16098532|NCT02174250|Drug|Istradefylline 40 mg|On Day 1, istradefylline 1 × 40-mg tablet administered alone
16098533|NCT02174250|Drug|Rifampin 300mg BID + istradefylline 40mg Day 8 only|On Days 1 - 20, rifampin 300mg BID; On Day 8, istradefylline 40 mg administered first with rifampin about 2 hours after istradefylline administration
16098534|NCT02174237|Drug|LNP1892|Tablets of two strengths (5 and 25 mg)
16098535|NCT02174237|Drug|Placebo|Matching placebo
16098536|NCT02174224|Behavioral|Brief Intervention|Goals of the bedside intervention will be to help the patient understand their risky behaviors that resulted in the injury and to assess and deescalate any threat of retaliatory violence by the patient. The outreach worker will: (1) develop a rapport with the patient by introducing themselves and describing their (outreach worker's) background and reason for the bedside visit; (2) assess the emotional response to the current injury; (3) ensure the patient and/or family understand the nature of the injury and ED course; (4) address any immediate concerns of the patient; and (5) develop a plan for staying safe following discharge.
16098537|NCT02174224|Behavioral|Case Management|Case management based on needs-assessment. Resource connection and mentoring.
16098538|NCT02174224|Behavioral|Standard Medical Care|This will include physician discretion for medical treatment and potentially a social worker visit as the physician sees fit for the patient. This will also include a list of resources that are typically needed and used for violently injured youth.
16098539|NCT02174211|Drug|Ranibizumab|Intravitreal injection of ranibizumab
16098540|NCT02174211|Drug|Aflibercept|Intravitreal injection of aflibercept
16098541|NCT02174198|Device|BioOss Collagen at the time of implant placement|Experimental: placement of BioOss Collagen No intervention: no BioOss Collagen
16098542|NCT02174185|Behavioral|validated health-related quality of life questionnaires|All eligible patients who agree to participate will be asked to fulfill three different validated health-related quality of life questionnaires (EORTC-QLQ-C30/BLM, FACT-BL and BCI) prior to surgery and at 3, 6, 12, 18 months postoperatively.
16098543|NCT02174172|Drug|Atezolizumab|Participant will receive atezolizumab 600 milligrams (mg) or 1200 mg by IV infusion q3w.
16098544|NCT02174172|Drug|Bevacizumab|Participant will receive Bevacizumab 15 milligrams per kilograms (mg/kg) IV infusion q3w.
16098545|NCT02174172|Drug|Interferon alfa-2b|Participants will receive Interferon alfa-2b 3, 5, or 10 million international units subcutaneously every other day for up to 3 doses per week.
16098546|NCT02174172|Drug|Ipilimumab|Participants will receive Ipilimumab 1, or 3 mg/kg IV, single dose, or multiple-dose regimen q3w for up to 4 cycles (Cycle = 21 days).
16098547|NCT02174172|Drug|Obinutuzumab|Obinutuzumab 1000 milligrams will be administered as pre-treatment on 2 consecutive days (Day -13 and Day -12) prior to treatment start with atezolizumab on Cycle 1, Day 1 (cycle length=21 days). An additional two doses of obinutuzumab will be administered on Days 85 and 86 of study treatment (Cycle 5, Day 1 and Cycle 5, Day 2).
16098548|NCT02174172|Drug|PEG-interferon alfa-2a|Participant will receive PEG-interferon alfa-2a 180 micrograms subcutaneous injection q3w for a total of 6 cycles (Cycle = 21 days).
16098549|NCT02174159|Drug|MK-8507|MK-8507 administered as a single oral dose
16098550|NCT02174146|Procedure|non-surgical periodontal therapy|supra and subgingival debridement
16098551|NCT02174120|Drug|propofol|
16098552|NCT02174120|Drug|etomidate|
16098553|NCT02174107|Radiation|External radiotherapy|The radiation technique used for each patient will be based on local clinical practices and on number of vertebae to treat between 1*8 Gy; 5*4 Gy and 10*3 Gy
16098554|NCT02174107|Procedure|Percutaneous vertebroplasty|
16098555|NCT02174094|Drug|Clobazam|
16098556|NCT02174094|Drug|Placebo|
16098557|NCT02174068|Drug|paracetamol 1000 mg per os, nefopam 60mg per os, paracetamol 1000 mg + nefopam 60 mg per os|
16098558|NCT02174055|Behavioral|Patient Interviews|participate in a brief interview
16098559|NCT02174055|Behavioral|newly developed questionnaire|10-16 patients will review draft items and participate in a cognitive interview. 15 older patients will complete the draft measure in order to generate preliminary psychometric data. All interviews will be audio recorded and transcribed by Ubiqus Transcription Company. The audio recordings are uploaded through Ubiqus's secure server and the transcribed audio is returned to the research staff within 48 hours.
16098560|NCT02174055|Behavioral|Pilot Testing the Draft Measure|The draft measure (approximately 35 items, described above) will be administered to a large sample of older cancer patients (n=150) to generate data to evaluate preliminary psychometric properties (item properties including measures of central tendency, skewness/kurtosis, internal consistency, test/re-test reliability, and construct validity (i.e, convergent and discriminant).and known group differences) to further winnow the measure to include approximately 20 items.
16098561|NCT02174042|Drug|Tangning Tongluo Capsule|Taken drugs 3 times a day, with each time 3 grains
16098562|NCT02174029|Procedure|Ventilation- mandatory|Patient days during which only a mandatory ventilation mode was used and prior to this no voluntary mode was used.
16098563|NCT02174029|Procedure|Ventilation- voluntary mode only|Patient days on a voluntary mode with no preceding days with a majority of time spend on a mandatory mode
16098564|NCT02174029|Procedure|Voluntary with preceding mandatory|Patient days on a voluntary vent mode with at least one day prior during which the majority of the vent mode was mandatory.
16098565|NCT02174016|Dietary Supplement|Ketogenic diet|
16098566|NCT02174003|Device|High intensity whole-body infrared heating|The Whole Body Hyperthermia system uses water-filtered infrared-A (wIRA) heat radiation. The rise in the body's core temperature is correspondingly rapid and well-tolerated. There are two phases of the thermal challenge, 1) Irradiation phase during which the patient lies recumbent with his/her head positioned outside the tent. The wIRA irradiators are arranged above the exposed upper part of the body; and 2) Heat retention phase during which the patient lies in the chamber with the walls of the tent positioned to retain heat. Core body temperatures will be raised to those comparable to a mild fever 37.8-38.5°C.
16098568|NCT02173977|Other|ARM A- Agonist/Antagonist protocol|In vitro fertilization (IVF/ICSI)
16098570|NCT02173964|Drug|pinaverium bromide|pinverin 50 mg per oral single dose versus simple water ingestion
16098571|NCT02173964|Drug|water|same amount of water for pinverin administration
16098572|NCT02173951|Drug|Deferiprone|"in arm 1 ( active comparator) will receive a starting dose of Deferiprone (DFP) 50mg⁄ kg ⁄ d, administered orally 3 times daily. Routine dose adjustments will be made according to serum ferritin trends and safety.
~Patients reaching serum ferritin ≥1000 will be subjected to dose escalation of DFP to 75 mg/kg/d.
~Patients in Placebo Comparator arm when reaching end point elevation of SF to around 1000 ng/ml or more or Tsat > 90 % and or LPI > 0.6 will start deferiprone 75 mg/kg/d"
16098573|NCT02173938|Other|Tobacco Dependence Treatment|face to face, outpatient tobacco dependence treatment based on the Public Health Service guidelines for treating tobacco use and dependence
16098574|NCT02173912|Drug|Candesartan cilexetil 16 mg and Amlodipine besylate 10mg (Reference)|"Sequence 1 receives Candesartan cilexetil 16 mg and Amlodipine besylate 10mg first, then CJ-30059 second, with at least 14-day wash-out period in between.
~Sequence 2 receives CJ-30059 first, then Candesartan cilexetil 16 mg and Amlodipine besylate 10mg second, with at least 14-day wash-out period in between."
16098575|NCT02173912|Drug|CJ-30059 (Test)|"Sequence 1 receives Candesartan cilexetil 16 mg and Amlodipine besylate 10mg first, then CJ-30059 second, with at least 14-day wash-out period in between.
~Sequence 2 receives CJ-30059 first, then Candesartan cilexetil 16 mg and Amlodipine besylate 10mg second, with at least 14-day wash-out period in between."
16098576|NCT02173899|Biological|varicella-1|Give the second varicella vaccine (a single 0.5 ml) and get blood samples at 0, 35-42 day
16098577|NCT02173899|Biological|varicella-3|Give the second varicella vaccine (a single 0.5 ml) and get blood samples at 0, 35-42 day
16098578|NCT02173899|Biological|varicella-5|Give the second varicella vaccine (a single 0.5 ml) and get blood samples at 0, 35-42 day
16098579|NCT02173886|Drug|Bupropion SR and XL|
16098580|NCT02173873|Drug|ziv-aflibercept drug|intravitreal injection of ziv-ablicerpt in one eye of each patient with retinal disease and poor vision
16098581|NCT02173860|Procedure|FFR-guided surgical revascularization|
16098582|NCT02173860|Procedure|Angio-guided surgical revascularization|
16098583|NCT02173847|Procedure|Penetrating keratoplasty|Femtosecond laser sculptured anvil graft. Laser welding of the flap in its final position. 12 months follow up study
16098584|NCT02173847|Device|Femtosecond laser|A commercial femtosecond laser to cut a particular shaped graft
16098585|NCT02173847|Device|Diode laser|Low power, near infrared diode laser for welding the surgical wound
16098586|NCT02173834|Other|18F- fluorodeoxyglucose-positron emission tomography Computed Tomography scan and 123I-metaiodobenzylguanidine-single-photon emission computed tomography scan|
16098587|NCT02173821|Procedure|Blood sampling|Blood sample will be collected at a single visit
16098588|NCT02173808|Biological|levonorgestrel butanoate|
16098589|NCT02173795|Drug|Berodual® Respimat®|
16098590|NCT02173795|Drug|Berodual® MA HFA|
16098591|NCT02173782|Drug|Berodual® Respimat ® high dose|
16098592|NCT02173782|Drug|Berodual® Respimat ® low dose|
16098593|NCT02173782|Drug|Berodual® MDI|
16098594|NCT02173782|Drug|Placebo|
16098595|NCT02173769|Drug|Spiriva® Respimat®|Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Microgramm plus Striverdi® Respimat®
16098596|NCT02173769|Drug|Striverdi® Respimat®|Spiriva® Respimat® plus Striverdi® Respimat® or Spiriva® 18 Microgramm plus Striverdi® Respimat®
16098597|NCT02173756|Drug|morphine gel|1 mg / ml ofmorphine hydrochloride, presented in a 5 mL sterile syringe (single dose), raspberry aroma, 30% glucose
16098598|NCT02173756|Drug|placebo gel|Sterile placebo gel with raspberry aroma, 30% glucose presented in 5 mL syringe (single dose) of the same appearance and the same packaging as morphine gel to maintain the blind
16098599|NCT02173743|Other|PRP|platelet enriched autologous blood plasma
16098600|NCT02173743|Other|Control|Regular barbotage/care as usual
16098601|NCT02173730|Drug|BIBR 1048 MS|BIBR 1048 MS capsule 150 mg
16098602|NCT02173730|Drug|Pantoprazole|Pantoprazole tablet 40 mg
16098603|NCT02173717|Drug|Dabigatran etexilate|150 mg Dabigatran etexilate
16098604|NCT02173717|Drug|Rifampicin|600 mg Rifampicin
16098605|NCT02173704|Biological|Bexsero®|Four doses administered in the anterolateral area of the right or left thigh.
16098606|NCT02173704|Biological|Routine vaccines|Infanrix-IPV + Hib®, Prevenar-13®, Engerix-B®, Priorix® and Varilrix® administered in the anterolateral area of the right or left thigh.
16098607|NCT02173691|Drug|Tiotropium inhalation powder capsules|
16098608|NCT02173691|Drug|Salmeterol inhalation aerosol|
16098609|NCT02173691|Drug|Placebo inhalation aerosol|
16098610|NCT02173691|Drug|Placebo inhalation powder capsules|
16098611|NCT02173678|Drug|COMBIVENT® HFA-MDI|
16098612|NCT02173678|Drug|COMBIVENT® CFC-MDI|
16098613|NCT02173678|Drug|Placebo HFA-MDI|
16098614|NCT02173665|Drug|BI 1356 BS - Powder in bottle (PIB)|
16098615|NCT02173665|Drug|BI 1356 BS - Tablet|
16098616|NCT02173665|Drug|Placebo|
16098617|NCT02173652|Drug|BI 1356, high dose|
16098618|NCT02173652|Drug|BI 1356, low dose|
16098619|NCT02173639|Drug|BI 1356/metformin|fixed dose combination tablet
16098620|NCT02173639|Drug|BI 1356|
16098621|NCT02173639|Drug|Metformin|
16098622|NCT02173626|Behavioral|Mindfulness Training|Participants enrolled on a first-come, first-serve basis, engaging in three 90-minute in person trainings, weekly online video-module trainings, and weekly teleconference coaching calls. Video-module trainings were available at all times, to be accessed at the participants' convenience. Journals and a guided meditation audio library were also provided.
16098623|NCT02173613|Other|procalcitonine|"The recommendations will be based on the level of PCT: 4 levels of advice will be given:
~It is highly recommended to stop antibiotics if PCT <0.1ng/ml, and the recommended stop if 0.1ng/ml <PCT <0.25 ng / ml.
~It is recommended to continue treatment if 0.25 ng / ml <PCT ng / ml.
~Finally, if the initial PCT greater than 10 ng / ml, a stop will be advised in case of reduction to less than 10% of baseline level."
16098624|NCT02173600|Behavioral|Group-level Intensive dietary Counselling|
16098625|NCT02173600|Behavioral|Individual-level Intensive Dietary Counselling|
16098626|NCT02173587|Dietary Supplement|Mussel oil capsules|Each mussel oil capsule contained 200mg thick shell mussel lipid extract and 200mg corn oil.Each patient in this group received daily four mussel oil capsules (containing 800mg mussel oil and 800mg corn oil) for first two months and two mussel oil capsules per day thereafter
16098627|NCT02173587|Dietary Supplement|Corn oil capsules|Each corn oil capsule contained 400mg corn oil.Each patient in this group received daily four corn oil capsules (1600mg corn oil) for first two months and two corn oil capsules per day thereafter
16098628|NCT02173574|Drug|DEB025|
16098629|NCT02173574|Drug|EDP239|
16098630|NCT02173561|Behavioral|Group Cognitive Processing Therapy-Cognitive Only|Cognitive Processing Therapy-Cognitive Only version (CPT-C) is an evidence-based form of Cognitive Behavioral Therapy (CBT) used to treat PTSD. CPT-C is a 12-session manualized program that focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. Sessions will be conducted in groups of 8-12 participants. Sessions will be conducted twice weekly for six weeks; each session is 90 minutes.
16098631|NCT02173561|Behavioral|Individual Cognitive Processing Therapy-Cognitive Only|Cognitive Processing Therapy-Cognitive Only (CPT-C) is an evidence-based form of Cognitive Behavioral Therapy (CBT) used to treat PTSD. CPT is a 12-session manualized program that focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. Individual sessions will be conducted twice weekly for six weeks; each session is 60 minutes.
16098632|NCT02173548|Drug|Anakinra|
16098633|NCT02173548|Drug|Placebo|
16098634|NCT02173535|Device|etafilcon test contact lens Variant AP|Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
16098635|NCT02173535|Device|etafilcon test contact lens Variant JG|Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
16098636|NCT02173535|Device|etafilcon test contact lens Variant CS|Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
16098637|NCT02173535|Device|etafilcon test contact lens Variant VC|Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
16098638|NCT02173535|Device|etafilcon test contact lens Variant LA|Subject will complete a questionnaire regarding cosmetic effect of the lens post insertion, then remove the lens.
16098639|NCT02173522|Device|Prostate artery embolization (PAE)|Embolization of the arteries carrying blood to the prostate. All PAE procedures will be conducted with Embosphere Microspheres.
16098640|NCT02173509|Other|Multidisciplinary and multifaceted educational intervention.|Outreach visits (40 minutes) which included a PowerPoint presentation and impress materials: poster; flyers; participation certificate and articles mentioned in the presentation. This outreach visit aimed to change the knowledge-attitudes previously identified in a previous study as being associated with poor prescribing of antibiotics in the case of physicians and propensity to dispense antibiotics without medical prescription in the case of pharmacists.
16098641|NCT02173496|Other|Colour Contrast Sensitivity|Reading of numbers or letters from a monitor
16098642|NCT02173483|Procedure|Quadriceps graft|
16098643|NCT02173470|Other|CT scan|The intervention group receives both standard care (chest x-ray) and an ultra low dose CT thorax without contrast.
16098644|NCT02173457|Drug|Chiglitazar|Take orally
16098645|NCT02173457|Drug|Sitagliptin|Take orally
16098646|NCT02173444|Other|Blood test|
16098647|NCT02173418|Drug|Phrenic nerve block with Ropivacaine|
16098648|NCT02173418|Drug|Phrenic nerve block with saline|
16098649|NCT02173405|Drug|OnabotulinumtoxinA|comparison of OnabotulinumtoxinA with placebo
16098650|NCT02173405|Drug|Placebo|comparison of placebo with investigational drug OnabotulinumtoxinA
16098651|NCT02173392|Drug|Brodalumab|Brodalumab is a large molecule for the treatment of inflammatory diseases
16098652|NCT02173379|Device|Absorb BVS|"Scaffold diameters: 2.5, 3.0 and 3.5 mm
~Scaffold lengths: 8, 12, 18, and 28 mm. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
~Once Absorb GT1™ BVS System is commercially available, it can also be used in the ABSORB IV trial. Scaffold diameters: 2.5, 3.0 and 3.5 mm of and scaffold lengths: 8, 12, 18, 23, and 28 mm.
~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
16098653|NCT02173379|Device|XIENCE|"Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm. The 3.25 mm is only available for XIENCE Xpedition
~Stent lengths: 8, 12, 15, 18, 23, and 28 mm
~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
16098654|NCT02173366|Behavioral|Change Club Intervention|
16098655|NCT02173353|Device|Ultrasound|Ultrasound to be done just before standard radiation therapy treatment
16098656|NCT02173327|Device|Continuously helm CPAP|6 hours
16098657|NCT02173327|Device|Intermittent Mask CPAP|10min every 2 hour for 18 hours
16098658|NCT02173314|Other|SAFE FC|SAFE - FC, a combination of SAFE (developed by ACTION for Child Protection) and Family Connections (developed by Ruth H. Young Center for Families and Children, University of Maryland School of Social Work) for Populations 1 and 2.
16098659|NCT02173301|Drug|XP23829 400 mg QD|active dose 1
16098660|NCT02173301|Drug|XP 23829 800 mg QD|active dose 2
16098661|NCT02173301|Drug|XP23829 400 mg BID|active dose 3
16098662|NCT02173301|Drug|Placebo|nonactive
16098663|NCT02173288|Drug|Standard medical therapy|
16098664|NCT02173288|Drug|Tolvaptan|
16098665|NCT02173288|Drug|Midodrine|
16098666|NCT02173262|Drug|G-CSF|
16098667|NCT02173262|Drug|Ciprofloxacin|
16098668|NCT02173249|Drug|AC 170 0.24%|1 drop in each eye 2 times daily for 1 week
16098669|NCT02173236|Other|platform-switched implants|
16098670|NCT02173236|Other|platform-matched implant|
16098671|NCT02173223|Drug|Rho-Kinase Inhibitor|
16098672|NCT02173184|Biological|Gynevac|1 IM injection of Gynevac per week, for 4 weeks (five injections in total). Vaccination can take place in no less than 7 days intervals (+3 days).
16098673|NCT02173184|Biological|Placebo|1 IM injection of Placebo per week, for 4 weeks (five injections in total). Vaccination can take place in no less than 7 days intervals (+3 days).
16098674|NCT02173171|Other|Information collection|Q3M Information collection
16098675|NCT02173158|Drug|lomitapide|
16098676|NCT02173145|Drug|azithromycin|Azithromycin is a macrolide antibiotic. 500mg Azithromycin will be given p.o. 3 times a week for 3 months. Azithromycin will be compared to placebo.
16098677|NCT02173145|Drug|placebo|Placebo will be given 3 times a wek over a period of 3 months.
16098678|NCT02173132|Drug|Acetyl-L-carnitine|
16098679|NCT02173132|Other|Placebo|
16098680|NCT02173119|Other|MRI post-TACE|Perform lipiodol delivery measurements with MRI post-TACE.
16098681|NCT02173106|Drug|steroid & Cyclosporin|oral methylprednisolone 0.4mg/kg/d and Cyclosporin for 6 months
16098682|NCT02173093|Biological|IL-2|Given SC
16098683|NCT02173093|Biological|GD2Bi-aATC|Given IV
16098684|NCT02173093|Biological|GM-CSF|Given SC
16098685|NCT02173093|Other|laboratory evaluations of immune responses|Correlative studies
16098687|NCT02173054|Other|Adapalene gel with Eucerin|Eucerin: 2 fingertip unit to cover all over the face twice a day. Adapalene gel: 2 fingertip unit to cover all over the face before going to bed
16098688|NCT02173054|Other|Adapalene gel|Adapalene gel: 2 fingertip unit to cover all over the face before going to bed
16098689|NCT02173054|Other|Adapalene gel with placebo moisturizer|Placebo: 2 fingertip unit to cover all over the face twice a day. Adapalene gel: 2 fingertip unit to cover all over the face before going to bed
16098690|NCT02173041|Other|Prevention Awareness Groups (PAG)|
16098691|NCT02173041|Other|Standard Care|
16098692|NCT02173015|Other|Compensatory step training|The training consists of a progression of anterior or posterior treadmill belt movements applied as the subject is standing or walking. This training specifically focuses on aspects important to trip and slip recovery. Subjects will participate in up to 6 sessions in 7 to 30 days. The training intensity (magnitude of disturbance delivered) is progressive and dependent on subject performance. Subjects will be instructed to respond with single or multiple steps in order to prevent a fall. All subjects will be outfitted with a safety harness to prevent injury. Up to 72 disturbances will be delivered each session.
16098693|NCT02173002|Other|myIBDcoach|
16098694|NCT02173002|Other|Standard care|
16098695|NCT02172976|Drug|Gemcitabine|
16098696|NCT02172976|Drug|Oxaliplatin|
16098697|NCT02172976|Drug|5-Fluorouracil|
16098698|NCT02172976|Drug|Irinotecan|
16098699|NCT02172976|Drug|Natriumfolinate|
16098700|NCT02172963|Biological|Decidual Stromal Cell therapy|Intravenous injection with placenta derived Decidual Stromal Cells. 1-2x10^6 cells/kg.
16098702|NCT02172937|Biological|Decidual Stromal Cells thawed in plasma|
16098703|NCT02172937|Biological|Decidual Stromal Cells thawed in human albumin|
16098704|NCT02172924|Biological|Early Decidual stromal cell therapy|Intervention given within 7 days after corticosteroids.
16098705|NCT02172924|Biological|Late Decidual stromal cell therapy|Intervention given after 7 days after corticosteroids.
16098706|NCT02172911|Biological|INO-3112|1.1 mL intramuscular (IM) injection of INO-3112 (VGX-3100 + INO-9012) was administered followed immediately by electroporation (EP) with CELLECTRA™-5P on Day 0, Week 4, Week 8, and Week 12.
16098707|NCT02172911|Device|CELLECTRA™-5P|CELLECTRA™-5P was used for EP following IM delivery of INO-3112 on Day 0, Week 4, Week 8, and Week 12.
16098708|NCT02172885|Biological|Mesenchymal Stem Cells|Mesenchymal Stem Cell Infusions
16098709|NCT02172872|Drug|standard combination chemotherapy|"Cycle 1
~daunorubicin (60 mg/m²) infusion (15-30 min) for 3 days
~cytarabine (200 mg/m²) continuous infusion (24 hrs) for 7 days.
~Cycle 2
~daunorubicin (45 mg/m²) infusion (15-30 min) for 3 days
~cytarabine (200 mg/m²) continuous infusion (24 hrs) for 7 days.
~Cycle 3 (mini-ICE)
~idarubicin (8 mg/m²) infusion (15-30 min) for 3 days
~cytarabine (100 mg/m²) continuous infusion (24 hrs) for 5 days
~etoposide (100 mg/m²) infusion (1 hr) for 3 days
~Cycle 4 (mini-ICE) (optional)
~idarubicin (8 mg/m²) infusion (15-30 min) for 3 days
~cytarabine (100 mg/m²) continuous infusion (24 hrs) for 5 days
~etoposide (100 mg/m²) infusion (1 hr) for 3 days"
16098710|NCT02172872|Drug|decitabine|"Cycle 1: decitabine (20 mg/m²) infusion (1 hr) for 10 days
~Cycle 2
~if bone marrow (BM) blasts < 5%: decitabine (20 mg/m²) infusion (1 hr) for 5 days
~if BM blasts >= 5%: decitabine (20 mg/m²) infusion (1 hr) for 10 days
~Cycle 3
~if BM blasts < 5%: decitabine (20 mg/m²) infusion (1 hr) for 5 days
~if BM blasts >= 5%: decitabine (20 mg/m²) infusion (1 hr) for 10 days
~Cycle 4-6: decitabine (20 mg/m²) infusion (1 hr) for 5 days
~Continuation therapy from Cycle 7 and until 'progression or toxicity': decitabine (20 mg/m²) infusion (1 hr) for 5 days or 3 days
~Note: All patients considered eligible for transplant should be consolidated with alloHCT once donor is available."
16098711|NCT02172859|Dietary Supplement|lumiVida™|
16098712|NCT02172859|Dietary Supplement|Placebo|
16098713|NCT02172846|Radiation|Proton beam radiation therapy (PBT)|
16098714|NCT02172846|Drug|Paclitaxel|
16098715|NCT02172846|Drug|Carboplatin|
16098716|NCT02172820|Behavioral|Financial incentives|Patients in the experimental group will receive financial incentives for completing exercise sessions.
16098717|NCT02172807|Drug|Tiotropium low|Tiotropium 18 µg inhalation capsule
16098718|NCT02172807|Drug|Tiotropium high|Tiotropium 36 µg inhalation capsule
16098719|NCT02172807|Drug|Placebo MDI|Placebo metered dose inhaler (MDI)
16098720|NCT02172807|Drug|Placebo inhalation capsule|
16098721|NCT02172807|Drug|Oxitropium|Oxitropium MDI (100 µg/puff)
16098722|NCT02172794|Drug|Tiotropium|
16098723|NCT02172794|Drug|Placebo to tiotropium|
16098724|NCT02172794|Drug|Salmeterol|
16098725|NCT02172794|Drug|Placebo to salmeterol|
16098726|NCT02172781|Drug|Ipratropium - unit dose vial|
16098727|NCT02172781|Drug|Tiotropium - inhalation capsule|
16098728|NCT02172781|Drug|Placebo matching tiotropium|
16098729|NCT02172781|Drug|Placebo matching ipratropium|
16098730|NCT02172768|Other|alternate dosing|treatment for 8 days with intravenous micafungin twice weekly
16098731|NCT02172768|Other|daily dosing|micafungin daily for 8 days
16098732|NCT02172768|Drug|micafungin|
16098733|NCT02172755|Drug|BIA 2-093|During the whole study, subjects were to receive a single 600 mg dose of BIA 2-093 (Phase A) followed by 600 mg BIA 2-093 once daily for 8 days in Phase B. Phase B was to begun 96 hours post-Phase A dose.
16098734|NCT02172742|Drug|BIA 2-093|BIA 2-093 1200 mg once-daily
16098735|NCT02172742|Drug|Placebo|matching placebo
16098736|NCT02172742|Drug|Digoxin|Digoxin (days 1 and 2: loading dose of 0.5 mg/day; days 3 to 8: 0.25 mg/day).
16098737|NCT02172729|Drug|Adductor canal block with 20 ml lidocaine, single bolus|Duration of an adductor canal block with 20 ml lidocaine, single bolus, administered as 5 or 15 mg/ml
16098738|NCT02172716|Procedure|Nonsurgical periodontal treatment|"All patients with GCP will receive full-mouth scaling and root planning under local analgesia in one session. Hopeless teeth will be treated similarly and extracted after de 30 days visit. Oral hygiene instructions will be given as needed.
~Supragingival scaling Periodontally healthy subjects will receive supra-gingival scaling and polishing in one appointment as needed. Oral hygiene instructions will be given as needed."
16098739|NCT02172703|Device|Non-invasive ICP measurement device|"The non-invasive ICP measurement device used in this study has been developed in the Telematic Science Laboratory at the Kaunas University of Technology, Lithuania.
~The non-invasive method is based on two-depth TCD technique for simultaneously measuring flow velocities in the intracranial and extracranial segments of the ophthalmic artery (OA)."
16098740|NCT02172690|Procedure|Laparoscopic Staging|Laparoscopic Staging
16098741|NCT02172677|Behavioral|Episodic memory task|
16098742|NCT02172677|Device|fMRI|
16098743|NCT02172664|Procedure|Self etch enamel etching|The adhesive will be applied according to manufacturer's instructions. If the lesion is greater than 2 mm in any dimension, incremental placement of Tetric EvoCeram composite (Ivoclar Vivadent) will occur with the first increment being placed against enamel.
16098744|NCT02172664|Procedure|selective etch protocol|Total Etch (37% phosphoric acid; Ivoclar) will be placed on the enamel margin with no intentional placement on the dentin within the lesion. The adhesive will then be applied as instructed by the manufacturer. Tetric EvoCeram composite will be placed, light-cured, finished, and polished in the same manner as for the self-etch group.
16098745|NCT02172664|Device|Adhese Universal|the universal adhesive, Adhese Universal , will be applied to the selected tooth following manufacturer instructions
16098746|NCT02172651|Drug|Vitamin D3|Take five 10,000 IU capsules (total 50,000 IU) once daily for 7 days, followed by one 10,000 IU capsule once daily until surgery.
16098747|NCT02172651|Drug|Placebo|Take five placebo capsules once daily for 7 days, followed by one placebo capsule once daily until surgery.
16098748|NCT02172638|Procedure|Fast-Track Protocol|
16098749|NCT02172638|Procedure|Usual management|
16098750|NCT02172625|Dietary Supplement|Protandim Dietary Supplement|This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given 675 mg per day (1 pill per day) of Protandim for 90 days. Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation.
16098751|NCT02172625|Other|Placebo Group|This was a randomized, block design, controlling for 5-km performance and sex. Subjects were given 675 mg per day (1 pill per day) of corn starch for 90 days. Subjects ran a 5-km time trial before and after the supplementation period. Blood samples were taken pre and post supplementation.
16098752|NCT02172612|Other|Arm 1 Education Session|Those included in the intervention group will undergo an educational session with the study pharmacist and one of the licensed prescribers from Sanders-Brown to discuss recommended changes in their treatment plan. If changes in medications are indicated by the pharmacist-prescriber team, and accepted by the patient, new prescriptions will be provided and a letter will be sent to the primary care physicians detailing the changes made and the rationale behind such changes.
16098753|NCT02172599|Behavioral|Sit-stand workstation provision|The research compares the effects of a sit-stand workstation only and a multi-component sit-stand workstation intervention including individual and organisation-level approaches, with usual office-based working practice (no sit-stand workstation) over 12 months.
16098754|NCT02172586|Drug|Telmisartan|
16098755|NCT02172586|Drug|Losartan|
16098756|NCT02172586|Drug|Hydrochlorothiazide|
16098757|NCT02172573|Drug|Pramipexole|
16098758|NCT02172573|Drug|Bromocriptine|
16098759|NCT02172573|Drug|Placebo pramipexole|
16098760|NCT02172573|Drug|Placebo bromocriptine|
16098761|NCT02172560|Drug|Tiotropium|
16098762|NCT02172547|Drug|Spiriva|
16098763|NCT02172534|Drug|Tiotropium bromide low|
16098764|NCT02172534|Drug|Tiotropium bromide medium|
16098765|NCT02172534|Drug|Tiotropium bromide high|
16098766|NCT02172534|Drug|Placebo|
16098767|NCT02172521|Drug|Tiotropium bromide|Tiotropium bromide18 micrograms by oral inhalation (1 x daily) with the HandiHaler®
16098768|NCT02172508|Drug|Tiotropium Inhalation Capsule|
16098769|NCT02172508|Drug|Placebo Lactose Capsule|
16098770|NCT02172495|Drug|Tiotropium bromide|Tiotropium bromide 18 micrograms
16098771|NCT02172482|Drug|Tiotropium bromide|Tiotropium bromide18 micrograms (capsule with powder for inhalation)
16098772|NCT02172469|Drug|Tiotropium inhalation powder capsule|
16098773|NCT02172469|Drug|Placebo Metered Dose Inhaler|
16098774|NCT02172469|Drug|Ipratropium Bromide Metered Dose Inhaler|
16098775|NCT02172469|Drug|Placebo inhalation powder capsule|
16098776|NCT02172456|Drug|99mTc-radiolabelled tiotropium|
16098777|NCT02172456|Drug|non-radiolabelled tiotropium|
16098778|NCT02172443|Drug|tiotropium inhalation powder capsules|
16098779|NCT02172443|Drug|Atrovent|
16098780|NCT02172443|Drug|placebo to Atrovent|
16098781|NCT02172443|Drug|placebo to tiotropium inhalation capsules|
16098984|NCT02171052|Drug|Dabigatran etexilate|
16098782|NCT02172430|Drug|Tiotropium powder inhalation capsules|Powder inhalation via the HandiHaler® once daily
16098783|NCT02172430|Drug|Tersigan®|2 puffs of oxitropium three times daily via MDI
16098784|NCT02172417|Drug|Cimetidine + Tiotropium|
16098785|NCT02172417|Drug|Ranitidine + Tiotropium|
16098786|NCT02172417|Drug|Tiotropium|
16098787|NCT02172404|Device|Placebo capsule administered via the HandiHaler®|
16098788|NCT02172404|Device|Ipratropium metered dose inhaler (MDI)|
16098789|NCT02172391|Drug|Tiotropium inhalation powder capsules|
16098790|NCT02172391|Drug|Placebo inhalation powder capsules|
16098791|NCT02172378|Drug|Tiotropium inhalation capsules|
16098792|NCT02172378|Drug|Placebo inhalation capsules|
16098793|NCT02172352|Drug|Ba 679 BR low dose|
16098794|NCT02172352|Drug|Ba 679 BR middle dose|
16098795|NCT02172352|Drug|Ba 679 BR high dose|
16098796|NCT02172352|Drug|Placebo inhalation powder|
16098797|NCT02172339|Drug|Tiotropium, solution ampoules|
16098798|NCT02172326|Drug|Tiotropium inhalation capsules for oral inhalation|Powder inhalation via HandiHaler®
16098799|NCT02172313|Drug|semaglutide|For oral administration.
16098800|NCT02172300|Drug|Tiotropium inhalation capsules|
16098801|NCT02172300|Drug|Placebo inhalation capsules|
16098802|NCT02172287|Drug|Tiotropium (Ba679 BR)|One capsule once daily by oral inhalation
16098803|NCT02172287|Drug|Salmeterol|Inhalation aerosol twice daily
16098804|NCT02172287|Drug|Placebo (for Tiotropium )|Placebo for Tiotropium delivered by inhalation capsule
16098805|NCT02172287|Drug|Placebo (for Salmeterol)|Placebo for Salmeterol delivered by inhalation aerosol
16098806|NCT02172274|Drug|[14C]-BI 10773 - oral solution|
16098807|NCT02172261|Drug|BI 10773|
16098808|NCT02172261|Drug|Glimepiride|
16098809|NCT02172248|Drug|BI 10773|
16098810|NCT02172248|Drug|Metformin|
16098811|NCT02172235|Drug|Pioglitazone|
16098812|NCT02172235|Drug|Pioglitazone - low dose|
16098813|NCT02172235|Drug|BI 10773 - low dose|
16098814|NCT02172235|Drug|BI 10773 - medium dose|
16098815|NCT02172235|Drug|BI 10773 - high dose|
16098816|NCT02172222|Drug|BI 10773|
16098817|NCT02172222|Drug|Linagliptin|
16098818|NCT02172209|Drug|BI 10773|
16098819|NCT02172196|Drug|BI 10773|
16098820|NCT02172196|Drug|Sitagliptin|
16098821|NCT02172183|Drug|Psychopharmacological treatment|methylphenidate or atomoxetine
16098822|NCT02172183|Behavioral|CBT group|
16098823|NCT02172170|Drug|BI 10773 single rising dose|
16098824|NCT02172170|Drug|Placebo|
16098825|NCT02172157|Drug|BI 1744 CL i.v.|
16098826|NCT02172157|Drug|BI 1744 CL oral|
16098827|NCT02172144|Drug|BI 1744 CL solution for inhalation|
16098828|NCT02172144|Drug|Placebo matching BI 1744 CL|
16098829|NCT02172144|Drug|Moxifloxacin (Avalox®)|
16098830|NCT02172131|Drug|BI 1744 CL|
16098831|NCT02172131|Drug|Placebo|
16098832|NCT02172118|Drug|BI 1774 CL|
16098833|NCT02172105|Drug|BI 1744 CL|
16098834|NCT02172105|Drug|Placebo|
16098835|NCT02172092|Drug|SodiumChloride|Infusion of SodiumChloride, blood samples to calculate extracellular volume.
16098836|NCT02172079|Other|Real mobilization-with-movement (MWM)|
16098837|NCT02172079|Other|Sham mobilization-with-movement (MWM)|
16098838|NCT02172066|Behavioral|Narrative Exposure Therapy (NET)|
16098839|NCT02172053|Other|Compensatory Workplace Exercise (CWE) - Comparative Group|The comparative group will receive warming up and stretching and light resisted exercise with elastic bands. The exercise will realize three times per week, 20 minutes for day in total 60 minutes per week. With warming up for 5 minutes and 15 minutes of the specific training . The exercise will realize in 3 series with 10 repetitions and rest 30 seconds between series.
16098840|NCT02172053|Other|Individual Resistance Exercise (IRE) - Intervention Group|Intervention group will receive warming up and stretching, and a specific resistance training with increase progress load. The exercise will realize three times per week, 20 minutes for day in total 60 minutes per week. With warming up and stretching for 5 minutes and 15 minutes of the specific training. The exercise will realize in 3 series with 10 repetitions and rest 30 seconds between series.
16098841|NCT02172040|Drug|Over-encapsulated 10 mg amlodipine besylate tablet|Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks
16098842|NCT02172040|Drug|Matched placebo capsule for over-encapsulated celecoxib capsule|Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks
16098843|NCT02172040|Drug|Over-encapsulated 200 mg celecoxib capsule|Over-encapsulated 200 mg celecoxib capsule once a day for two weeks
16098844|NCT02172040|Drug|Matched placebo capsule for over-encapsulated amlodipine besylate tablet|Matched placebo capsule for over-encapsulated amlodipine besylate tablet once a day for two weeks
16098845|NCT02172027|Device|Immunomagnetic Detection|Analysis of pleural effusion through immunomagnetic detection device.
16098846|NCT02172014|Drug|midazolam and fentanyl citrate infusion|comparing the sedative effect of combination of midazolam and fentanyl citrate versus combination of midazolam and normal saline for 48 hours during ventilator care
16098847|NCT02172014|Drug|midazolam and normal saline infusion|comparing the sedative effect of combination of midazolam and fentanyl citrate versus combination of midazolam and normal saline for 48 hours during ventilator care
16098848|NCT02172001|Drug|Iron isomaltoside 1000|
16098849|NCT02172001|Drug|Natrium Chloride 0,9%|100 ml or 5 ml
16098850|NCT02171988|Drug|Propranolol|Start propranolol 10mg bid, and then dose up to 20mg bid after one month if tolerable
16098851|NCT02171988|Drug|Bisoprolol|Start bisoprolol 2.5mg qd P.O, and then dose up to 5mg qd. if tolerable
16098852|NCT02171988|Drug|Propranolol+pyridostigmine|Start propranolol+pyridostigmine 10mg bid +30mg bid, and then dose up to 20mg bid+30mg bid. if tolerable.
16098853|NCT02171988|Drug|Bisoprolol+pyridostgmine|Start bisoprolol+pyridostgmine 2.5mg qd+30mg bid, and then, dose up to 5mg qd+30mg bid. if tolerable
16098931|NCT02171429|Other|Adalimumab Placebo|Placebo matching to adalimumab will be administered SC at Weeks 0, 2, 4, 6, and 8.
16098854|NCT02171975|Procedure|pre-procedure ultrasound guided paramedian spinal|In group P, a portable ultrasound unit was used for initial pre-procedural marking. The interspinous space at which the clearest image of the anterior complex (ligamentum flavum dura complex- LFD) and posterior complex (posterior longitudinal ligament- PLL) was obtained, was selected. At the selected interspace, and with the probe positioned to obtain the clearest ultrasound image, a skin marker was used to mark the midpoint of the long border of the probe and the midpoints of the short borders of the probe . At the same horizontal level as the midpoint of the long border of the probe, the midpoint of the line drawn between the two short border midpoints of the probe was used as paramedian insertion point for the spinal needle.
16098855|NCT02171975|Procedure|Conventional landmark guided midline spinal anaesthetic|Spinal anaesthesia was administered based on conventional landmark based midline approach.
16098856|NCT02171962|Device|Zilver® PTX® Drug-Eluting Peripheral Stent|Zilver® PTX® Drug-Eluting Peripheral Stent for treatment of lesions of the above-the-knee femoropopliteal artery
16098857|NCT02171949|Biological|Infusion of bone marrow mononuclear cells.|Patients on this group will receive therapy with mononuclear cells. The cells will be diluted on saline and then injected on the hepatic artery through femoral artery puncture.
16098858|NCT02171936|Other|Questionnaire EPICES (Evaluation of the Precariousness and the Disparities of Health for the Centers of Examination of Health).|
16098859|NCT02171910|Drug|Doxapram|
16098860|NCT02171910|Drug|Placebo|An injection and infusion of normal saline (NaCl 0.9%) as a placebo comparator to doxapram
16098861|NCT02171897|Procedure|Osteosynthesis|
16098862|NCT02171897|Procedure|Total hip replacement|
16098863|NCT02171884|Other|Sample of cord blood|
16098864|NCT02171884|Other|Sample of placenta|
16098865|NCT02171871|Other|exposed to a smoking environment|Then the subjects will be exposed to a smoking environment for 20 minutes, under a continuous measurement of emitted particles using the SIDEPAK AM510 in Pm level 2,5=250, in a closed space of 20 m3. The passive smoking environment will be achieved via a smoking machine. Afterwards, the subject will again undergo IOS in four positions (standing, sitting, right and left lateral decubitus) and nitrogen washout test in two positions (sitting and decubitus). Thanks to the above mentioned techniques, changes in measured parameters will be evaluated.
16098866|NCT02171845|Other|surgical biopsies|
16098867|NCT02171832|Drug|BI 1744 CL, low dose|
16098868|NCT02171832|Drug|BI 1744 CL, high dose|
16098869|NCT02171819|Biological|IVACFLU-A/H5N1, 7.5 mcg|Contains 7.5 mcg HA and 0.6 mg of aluminum hydroxide adjuvant per 0.5 mL dose.
16098870|NCT02171819|Biological|IVACFLU-A/H5N1, 15 mcg|Contains 15 mcg HA and 0.6 mg of aluminum hydroxide adjuvant per 0.5 mL dose
16098871|NCT02171819|Other|Placebo Comparator|PBS, pH 7.2 in 0.5 mL single-dose vials.
16098872|NCT02171806|Drug|BI 1744 CL|
16098873|NCT02171806|Drug|Placebo|
16098874|NCT02171793|Drug|BI 1744 CL|
16098875|NCT02171793|Drug|Placebo|
16098876|NCT02171780|Drug|BI 1744 CL|
16098877|NCT02171780|Drug|Placebo|
16098878|NCT02171767|Drug|BIBW 2992 MA2 - single rising dose|
16098879|NCT02171754|Drug|BIBW 2992|
16098880|NCT02171754|Drug|Ritonavir|
16098881|NCT02171741|Drug|BIBW 2992|continuous daily dosing for 20 or 13 days
16098882|NCT02171741|Drug|Docetaxel|single infusion on day 1
16098883|NCT02171728|Drug|BIBW 2992|
16098884|NCT02171715|Drug|BIBW 2992 MA2|film-coated immediate release tablet - final formulation
16098885|NCT02171715|Drug|BIBW 2992 MA2|film-coated immediate release tablet - trial formulation II
16098886|NCT02171715|Drug|BIBW 2992 MA2|powder for oral solution
16098887|NCT02171702|Drug|BIBW 2992|
16098888|NCT02171689|Drug|[14C]- BIBW 2992 MA2|
16098889|NCT02171676|Drug|Docetaxel|
16098890|NCT02171676|Drug|BIBW 2992|
16098891|NCT02171663|Drug|BIBW 2992|
16098892|NCT02171650|Drug|BIBW 2992|
16098893|NCT02171637|Drug|BIBW 2992|escalating doses
16098894|NCT02171624|Drug|dabigatran etexilate|
16098895|NCT02171624|Drug|quinidine|
16098896|NCT02171611|Drug|Dabigatran etexilate pellets|
16098897|NCT02171611|Drug|Dabigatran etexilate powder|
16098898|NCT02171611|Drug|Dabigatran etexilate capsule|
16098899|NCT02171598|Drug|Clopidogrel|
16098900|NCT02171598|Drug|Dabigatran high dose|
16098901|NCT02171598|Drug|Dabigatran low dose|
16098902|NCT02171585|Drug|Dabigatran etexilate|
16098903|NCT02171585|Drug|Clarithromycin|
16098904|NCT02171572|Drug|Dabigatran etexilate low|
16098905|NCT02171572|Drug|Dabigatran etexilate high|
16098906|NCT02171559|Drug|Enoxaparin prefilled syringes|
16098907|NCT02171559|Drug|Dabigatran etexilate capsules|
16098908|NCT02171546|Drug|Dabigatran etexilate capsules|
16098909|NCT02171546|Drug|Quinidine sulfate tablets|
16098910|NCT02171546|Drug|Fexofenadine tablets|
16098911|NCT02171533|Drug|dabigatran|
16098912|NCT02171533|Drug|Verapamil|
16098913|NCT02171533|Drug|Verapamil ER|
16098914|NCT02171520|Drug|Dabigatran etexilate generation I|
16098915|NCT02171520|Drug|Dabigatran etexilate generation II|
16098916|NCT02171507|Drug|Dabigatran etexilate|
16098917|NCT02171507|Drug|Diclofenac|
16098918|NCT02171494|Drug|IVAX Warfarin|
16098919|NCT02171494|Drug|BMS Coumadin|
16098920|NCT02171481|Drug|Dabigatran etexilate polymorph II|
16098921|NCT02171481|Drug|Dabigatran etexilate polymorph I|
16098922|NCT02171468|Drug|Dabigatran high dose|
16098923|NCT02171468|Drug|Dabigatran low dose|
16098924|NCT02171455|Drug|Dabigatran etexilate low dose|
16098925|NCT02171455|Drug|Dabigatran etexilate medium dose|
16098926|NCT02171455|Drug|Dabigatran etexilate high dose|
16098927|NCT02171455|Drug|Placebo|
16098928|NCT02171442|Drug|BIBR 953 ZW Intravenously|5 mg, 2.8 MBq (76 µCi)
16098929|NCT02171442|Drug|BIBR 1048 Oral Solution|200 mg free base, 2.8 MBq (76 µCi)
16098930|NCT02171429|Drug|Adalimumab|Adalimumab 160 milligrams (mg) will be administered subcutaneously (SC) at Week 0; 80 mg SC at Week 2; 40 mg SC at Weeks 4, 6 and 8.
16098932|NCT02171429|Drug|Etrolizumab|Etrolizumab 105 mg will be administered SC every 4 weeks (Q4W) up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]).
16098933|NCT02171429|Other|Etrolizumab Placebo|Placebo matching to etrolizumab will be administered SC once every 4 weeks (Q4W) up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]).
16098934|NCT02171416|Drug|Rilonacept|
16098935|NCT02171416|Drug|Placebo|
16098936|NCT02171390|Drug|Testosterone 250mg injection|The testosterone 250mg ester intramuscular injections performed in three weeks
16098937|NCT02171390|Drug|Testosteron 50 mg transdermal gel|50mg testosterone gel implemented on every night
16098938|NCT02171377|Device|group 2 : quadricipital electrical stimulation|bilateral quadricipital electrical stimulation 5 sessions a week, (6 - 8 weeks)
16098939|NCT02171377|Other|pulmonary rehabilitation|exercise training, 3 to 5 times per week, 8 weeks
16098940|NCT02171377|Device|muscular electrical stimulation|Bilateral quadricipital electrical stimulation 30 min, 5 times per week, 8 weeks,in addition to pulmonary rehabilitation
16098941|NCT02171377|Other|pulmonary rehabilitation|exercise training, 45 min, 3 to 5 times per week, 8 weeks
16098942|NCT02171364|Procedure|Virtual ablation in based 3D CT of patient who diagnosed AF|
16098943|NCT02171364|Procedure|conventional ablation based on physician's personal experience|
16098944|NCT02171351|Device|effect of neuromuscular electrostimulation (NMES)|Each subject (type 2 diabetes and control) will be assessed with plethysmography during a single session of neuromuscular electrostimulation (NMES).
16098945|NCT02171351|Device|effect of neuro electrostimulation (NES)|Each subject (type 2 diabetes and control) will be assessed with plethysmography during a single session of neuro electrostimulation (NES)
16098946|NCT02171351|Other|effect of voluntary contractions (VC)|Each subject (type 2 diabetes and control) will be assessed with plethysmography during a single session of voluntary contractions (VC)
16098947|NCT02171338|Other|PCT-level|PCT-level is available to the treating doctor.
16098948|NCT02171338|Behavioral|Antibiotic treatment based on PCT-level|"PCT-level is available to the treating doctor and the decision whether or not to treat with antibiotic is based on the level of PCT.
~The type of antibiotic chosen to treat is based on the existing antibiotic treatment guidelines of Holbaek Hospital and includes the antibiotics listed above."
16098949|NCT02171325|Drug|irinotecan|60 mg/m2、65mg/m2、70mg/m2、75mg/m2、80mg/m2、85mg/m2、90mg/m2、95mg/m2、100mg/m2
16098950|NCT02171312|Device|iDETECT Assessment|The iDETECT device is an open platform for an evaluation of cognitive, balance, and oculomotor performance after mild traumatic brain injury (mTBI). It is a rugged, portable, neurocognitive assessment tool designed specifically for use in field and triage settings for the rapid evaluation of functional neurologic impairment after potential concussive injury. The apparatus includes an enhanced heads-up display visor with integration motion detection technology, noise-reducing headphones optimized with pink noise, and a handheld display for test battery administration, subject response inputs, and user data output. iDETECT will be used to assess multimodal neurologic function in participants.
16098951|NCT02171312|Behavioral|Routine Balance and Vestibular Testing|A clinician will assess balance and vision by standard of care routine tests for neurologic function.
16098952|NCT02171299|Procedure|Wound infiltration with local anaesthetic|
16098953|NCT02171299|Drug|Ropivacaine|
16098954|NCT02171273|Behavioral|Circadian Disruption|Following a baseline of adequate time in bed, study participants will spend 3 weeks on a daily jet-lag schedule (where each day is longer than 24 hours).
16098955|NCT02171273|Behavioral|Sleep Restriction|Following a baseline of adequate time in bed, study participants will have a shortened opportunity for sleep during each 24-hour day (for three weeks).
16098956|NCT02171273|Behavioral|Control|Following a baseline of adequate time in bed, study participants will continue to have adequate time in bed and opportunity for sleep during each 24-hour day, for 3 weeks.
16098957|NCT02171260|Drug|Eribulin Mesylate|Eribulin mesylate will be administered intravenously on Days 1 and 8 of each 21-day cycle.
16098958|NCT02171247|Drug|Isovue 370|Isovue 370 is a contrast agent with increased iodine concentration.
16098959|NCT02171247|Drug|Visipaque 320|Visipaque 320 is standard protocol.
16098960|NCT02171234|Drug|Placebo|
16098961|NCT02171234|Drug|BIA 2-093|
16098962|NCT02171221|Drug|Oral DFP-11207|
16098963|NCT02171208|Drug|dimethyl fumarate - Reference form|single dose 240 mg
16098964|NCT02171208|Drug|dimethyl fumarate - Test form|single dose 240 mg
16098965|NCT02171195|Drug|BIA 2-093|BIA 2-093 20mg, 50 mg, 100 mg, 200 mg, 400 mg, 600 mg, 900 mg, 1200 mg
16098966|NCT02171195|Drug|Placebo|Identical placebo administered as oral tablets with 200 ml potable water.
16098967|NCT02171182|Drug|Qutenza|capsaicin patch
16098968|NCT02171156|Drug|nintedanib|soft gelatin capsule
16098969|NCT02171143|Drug|ASP2409|intravenous (IV)
16098970|NCT02171143|Drug|Placebo|intravenous (IV)
16098971|NCT02171130|Drug|Nasal Glucagon|3 mg nasal glucagon powder
16098972|NCT02171117|Procedure|microtransplantation|infusion of granulocyte colony stimulating factor (G-CSF) mobilized HLA-mismatched peripheral blood stem cells (GPBSC)
16098973|NCT02171117|Biological|HLA-mismatched donor peripheral stem cell infusion|
16098974|NCT02171104|Biological|Stem Cell Transplantation|Infusion given on Day 0
16098975|NCT02171104|Drug|IMD Preparative Regimen|"Anti-thymocyte Globulin (ATG)
~Fludarabine
~Busulfan"
16098976|NCT02171104|Drug|Osteopetrosis Only Preparative Regimen|"Anti-thymocyte Globulin (ATG)
~Fludarabine
~Busulfan
~Thiotepa"
16098977|NCT02171104|Drug|Osteopetrosis Haploidentical Only Preparative Regimen|"Rituximab
~Alemtuzumab
~Busulfan
~Fludarabine"
16098978|NCT02171104|Drug|cALD SR-A (Standard-Risk, Regimen A)|N-acetylcysteine start day +1 through day +28
16098979|NCT02171104|Drug|cALD SR-B (Standard-Risk, Regimen B)|N-acetylcysteine start day +1through day +56
16098980|NCT02171104|Drug|cALD HR-D (High-Risk, Regimen C)|N-acetylcysteine and celecoxib start day of admission (prior to conditioning regimen) and continue through day +100
16098981|NCT02171104|Drug|cALD HR-D (High-Risk, Regimen D)|N-acetylcysteine, celecoxib, vitamin E and alpha lipoic acid start day of admission (prior to conditioning regimen) and continue through day +100
16098982|NCT02171065|Device|sham|
16098983|NCT02171065|Device|ABSORB BVS|
16098988|NCT02171026|Drug|Dabigatran etexilate|
16098989|NCT02171026|Drug|Amiodarone|
16098990|NCT02171013|Drug|Dabigatran polymorph I (≈ 83%) and polymorph II (≈17%)|
16098991|NCT02171013|Drug|Dabigatran polymorph I|
16098992|NCT02171000|Drug|BIBR 1048 MS|150 mg capsules, b.i.d, 7 days
16098993|NCT02170987|Drug|Dabigatran etexilate low|
16098994|NCT02170987|Drug|Dabigatran etexilate high|
16098995|NCT02170987|Drug|Moxifloxacin|
16098996|NCT02170987|Drug|Placebo|
16098997|NCT02170974|Drug|BIBR 1048 MS polymorph II|
16098998|NCT02170974|Drug|BIBR 1048 MS polymorph I|
16098999|NCT02170948|Drug|Dexmedetomidine|An anesthetic concoction of 2% Lidocaine, 1% Ropivacaine, and Dexmedetomidine diluted solution will be provided via a series of anesthetic injections related to the ankle block procedure
16099000|NCT02170935|Drug|BIBR 1048 capsule|
16099001|NCT02170922|Drug|BIBR 1048 MS tablet|
16099002|NCT02170922|Drug|BIBR 1048 MS solution|
16099003|NCT02170909|Drug|BIBR 1048 MS low dose|
16099004|NCT02170909|Drug|BIBR 1048 MS medium dose|
16099005|NCT02170909|Drug|BIBR 1048 MS high dose|
16099006|NCT02170896|Drug|BIBR 1048 MS Capsule A|
16099007|NCT02170896|Drug|BIBR 1048 MS Capsule B|
16099008|NCT02170896|Drug|BIBR 1048 MS Capsule C|
16099009|NCT02170896|Drug|BIBR 1048 MS Capsule D|
16099010|NCT02170896|Drug|BIBR 1048 MS tartaric acid solution|
16099011|NCT02170896|Drug|Pantoprazole|
16099012|NCT02170883|Other|Interactive SMS|
16099013|NCT02170883|Other|Usual care|
16099014|NCT02170870|Drug|Exendin 9-39|Exendin 9-39 will be administered intravenously (1,200 pmol/kg bolus followed by infusion at 300 pmol/kg/min).
16099015|NCT02170870|Drug|Microlipid|Lipid infusion {66.7 mL Microlipid (0.5 gm/mL diluted in water to 222 ml).
16099016|NCT02170870|Drug|Placebo|Normal saline infusion will be prepared to match the appearance of Exendin 9-39
16099017|NCT02170857|Drug|Hyaluronic Acid|This material will be used in conjunction with the ordinary surgical procedure
16099018|NCT02170844|Drug|BIBR 1048 MS|
16099019|NCT02170844|Drug|Placebo of BIBR 1048 MS|
16099020|NCT02170831|Drug|BIBR 1048 MS low|
16099021|NCT02170831|Drug|BIBR 1048 MS medium 1|
16099022|NCT02170831|Drug|BIBR 1048 MS medium 2|
16099023|NCT02170831|Drug|BIBR 1048 MS high|
16099024|NCT02170831|Drug|BIBR 1048 MS placebo|
16099025|NCT02170818|Other|Educational Workshop on Speaking-Up|Educational workshop including lecture, discussion, role-play Concepts include: 2-challenge rule, pairing advocacy and inquiry
16099026|NCT02170818|Other|Unrelated Education (CPR)|Unrelated Education (CPR workshop) including: lecture, discussion Topics covered: Cardiac Life Support algorithms, CPR, Medications
16099027|NCT02170805|Drug|BIBR 1048 MS capsule formulation A|BIBR 1048 MS, formulation A 50 mg
16099028|NCT02170805|Drug|BIBR 1048 MS capsule formulation B|BIBR 1048 MS, formulation B 50 mg
16099029|NCT02170805|Drug|BIBR 1048 MS powder plus solution|BIBR 1048 MS, powder plus solution 50 mg
16099030|NCT02170805|Drug|Pantoprazole|Pantoprazole 40 mg
16099031|NCT02170792|Drug|BIBR 1048 MS|Low, medium or high dose
16099032|NCT02170792|Drug|Ranitidine|150mg
16099033|NCT02170779|Behavioral|Spasticity: Take Control|4 visits: baseline, view and discuss DVDs, practice stretching, outcome measures
16099034|NCT02170779|Other|Usual care|2 visits: baseline followed by usual care of brochure for stretching then outcome measures
16099035|NCT02170766|Drug|BIBR 1048 low1|
16099036|NCT02170766|Drug|BIBR 1048 low2|
16099037|NCT02170766|Drug|BIBR 1048 medium|
16099038|NCT02170766|Drug|BIBR 1048 high|
16099039|NCT02170766|Drug|Pantoprazole|
16099040|NCT02170753|Procedure|Regional manual therapy|The experimental group will receive regional thoracic, pelvic, and hip manual therapy and a standard physical therapy approach including motor control exercise and local lumbar spine manual therapy.
16099041|NCT02170753|Procedure|Standard physical therapy|The control group will receive standard physical therapy including motor control exercise and local lumbar spine manual therapy.
16099042|NCT02170740|Drug|BIBR 1048 MS - low dose|
16099043|NCT02170740|Drug|BIBR 1048 MS - high dose|
16099044|NCT02170740|Drug|BIBR 1048 MS + Pantoprazole|
16099045|NCT02170727|Drug|DCV/ASV/BMS-791325|
16099046|NCT02170714|Other|Clinical and laboratory assessment|Clinical assessment through PUCAI and laboratory data (Erythrocyte Sedimentation Rate, C-Reactive Protein, hemoglobin, albumin, hematocrit, ferritin) were recorded at admission and at day 3 and 5. All patients were treated according to the 2011 ECCO-ESPGHAN guidelines for ASC: all patients received intravenous (iv) corticosteroids (methylprednisolone 1.5-2 mg/Kg/day) for 5 days. Patients not responding to corticosteroids (i.e. PUCAI>65 at day 5) started Infliximab (IFX, 5 mg/Kg 0,2,6 then every 8 weeks) as second-line therapy. All therapies were decided at the discretion of the referral gastroenterologist and recorded on standardized case report forms
16099047|NCT02170701|Drug|BIBR 1048|Ascending doses (in mg) given twice daily
16099048|NCT02170688|Drug|Isovue 370|All contrast media doses administered for this study are within the FDA approved dose range in the package insert.
16099049|NCT02170688|Other|Weight calculation|
16099050|NCT02170675|Drug|Dabigatran etexilate|
16099051|NCT02170675|Drug|Ketoconazole|
16099052|NCT02170662|Drug|Bimatoprost|Bimatoprost 0.03% ophthalmic solution as purchased from the manufacturer will be the active drug.
16099053|NCT02170662|Drug|Placebo|
16099054|NCT02170649|Drug|BIA 2-093|
16099055|NCT02170636|Drug|BIBR 1048 MS Capsule E|50 mg BIBR 1048 MS
16099056|NCT02170636|Drug|BIBR 1048 MS Capsule F|50 mg BIBR 1048 MS
16099057|NCT02170636|Drug|BIBR 1048 MS Capsule G|50 mg BIBR 1048 MS
16099058|NCT02170636|Drug|BIBR 1048 MS Tablet H|50 mg BIBR 1048 MS
16099059|NCT02170636|Drug|BIBR 1048 MS Drinking solution|50 mg BIBR 1048 MS tartaric acid solution
16099060|NCT02170636|Drug|Pantoprazole|40 mg Pantoprazole
16099061|NCT02170623|Drug|BIBR 1048 MS Capsule I|25 mg BIBR 1048 MS
16099062|NCT02170623|Drug|BIBR 1048 MS Capsule K|50 mg BIBR 1048 MS
16099063|NCT02170623|Drug|Pantoprazole|40 mg pantoprazole
16099064|NCT02170623|Drug|BIBR 1048 MS drinking solution|50 mg BIBR 1048 MS powder plus solution
16099065|NCT02170610|Drug|BIBR 1048 MS|
16099066|NCT02170610|Drug|Pantoprazole|
16099067|NCT02170597|Drug|BIBR 1048 MS HPMC capsule|
16099068|NCT02170597|Drug|BIBR 1048 MS gelatine capsule|
16099069|NCT02170584|Drug|BIBR 953 ZW IV|
16099070|NCT02170584|Drug|BIBR 1048 MS tablet|
16099071|NCT02170584|Drug|BIBR 1048 MS oral solution|
16099072|NCT02170584|Drug|BIBR 953 ZW IV Placebo|
16099073|NCT02170571|Drug|Dabigatran etexilate|
16099074|NCT02170558|Device|TM- Ardis implant and Metal Reduction CT software|TM- Ardis implant and Metal Reduction CT software
16099075|NCT02170545|Other|Dual Energy Computed Tomography|A Dual Energy Computed Tomography scan will be performed on both upper arms.
16099076|NCT02170532|Drug|levalbuterol|0.5 ml. levalbuterol
16099077|NCT02170532|Drug|saline|0.5ml saline
16099078|NCT02170532|Other|levalbuterol MDI|
16099079|NCT02170532|Device|breath actuated nebulizer|
16099080|NCT02170532|Device|aerochamber max|
16099081|NCT02170532|Drug|ipratroprium|
16099082|NCT02170519|Drug|Inhaled Iloprost|A 20 mcg dose of Iloprost will be given initially.
16099083|NCT02170506|Device|Urostim 2 stimulation|Sensory transcutaneous electrical stimulation will be started for a period of 20 minutes. It is applied by means of two surface electrodes placed under chin stimulation of both sides of the center line of the preceding side. Sensory transcutaneous electrical stimulation will inhibit the cerebral control of swallowing.
16099084|NCT02170467|Other|assessment of the intestinal permeability|
16099085|NCT02170454|Procedure|magnetic stimulation|rTMS on pharyngeal cortical area in healthy subjects or sham rTMS on pharyngeal cortical area in healthy subjects
16099086|NCT02170415|Drug|Protective analgesia|"Participants in the intervention arm of the study (if no contraindications exist) will be administered one pre-procedure dose of 150mg of oral pregabalin.
~For a total of five days post-procedure the participants in the intervention limb of the study will take oral pregablin twice daily at a dose of 75mg twice a day."
16099087|NCT02170415|Other|Pain education|Participant will receive a pain education leaflet
16099088|NCT02170415|Behavioral|Psychological support|Participants demonstrating psychological morbidity will be offered psychological support prior to surgery
16099089|NCT02170415|Procedure|Paravertebral block/local anaesthetic infiltration|Patients on the intervention limb will be encouraged to have a paravertebral block if not contraindicated
16099090|NCT02170415|Other|Daily visits from pain team whilst in hospital|
16099091|NCT02170402|Biological|Octocog alfa (recombinant human coagulation factor VIII)|"Part 1: Pharmacokinetic (PK) analysis - Subset of 24 participants
~Part 2: On-demand treatment regimen
~Part 3: Prophylaxis treatment regimen"
16099092|NCT02170389|Other|Laboratory Biomarker Analysis|Correlative studies
16099093|NCT02170389|Procedure|Nephrectomy|Undergo partial or radical nephrectomy
16099094|NCT02170389|Biological|Renal Cell Carcinoma/CD40L RNA-Transfected Autologous Dendritic Cell Vaccine AGS-003|Given ID
16099095|NCT02170376|Drug|BIA 9-1067|BIA 9-1067 25 mg and 50 mg
16099096|NCT02170376|Drug|Entacapone|Entacapone (ENT), over-encapsulated tablet 200 mg
16099097|NCT02170376|Drug|Placebo|PLC, placebo
16099098|NCT02170376|Drug|Levodopa/carbidopa|Levodopa/carbidopa, tablet 100/25 mg
16099099|NCT02170363|Device|Left Ventricular Assist System (LVAS)|Implantation of left ventricular assist device for hemodynamic support
16099100|NCT02170350|Procedure|Meditation therapy|Use brief mindful meditation practice
16099101|NCT02170350|Other|Quality-of-life assessment|Ancillary studies
16099102|NCT02170350|Other|Questionnaire administration|Ancillary studies
16099103|NCT02170337|Drug|AMG 282|AMG 282 is for the treatment of subjects with chronic rhinosinusitis with nasal polyps
16099104|NCT02170337|Drug|Placebo|Contains no active drug
16099105|NCT02170324|Drug|Exenatide|
16099106|NCT02170324|Drug|Placebo|
16099107|NCT02170311|Drug|Z-213|
16099108|NCT02170298|Drug|Lisdexamfetamine|Participants will be given either the study drug or placebo in tablet form. All participants will start with a 20 mg dose and will be titrated up to a 70 mg daily dose over 9 weeks. Participants between 12-18 years of age will be titrated in 10 mg increments and participants between 18-25 years of age in 10-20 mg increments.
16099109|NCT02170285|Device|Interventional TDCS|The primary intervention will be cathodal (inhibitory) tDCS over non-lesioned M1. This will be targeted using TMS baseline mapping data and neuronavigation (Brainsight2, Rogue Research, Montreal) individualized to the subjects MRI. Soft, replaceable 25cm2 electrodes will be placed over clean, dry scalp with the cathode over marked M1 and the reference electrode over contralateral forehead/orbit consistent with standard protocols. The current-controlled DC stimulator (neuroConn GmbH, Ilmenau, GE) will be turned up slowly over 30 seconds to the treatment current of 1.0 mA. TDCS will be administered each day during the first 20 minutes of the 90 minute therapy session. Child, family, and both treating and measuring occupational therapists are blinded to treatment allocation.
16099110|NCT02170285|Device|Sham TDCS|Sham subjects will undergo exactly the same tDCS protocol as outlined above. This includes the initial stimulation sequence, generating the initial transient scalp sensations identical to the treatment group. The stimulator will be programmed by the technologist to automatically ramp down to off over 30 seconds after 120 seconds of stimulation.
16099111|NCT02170272|Behavioral|Home-based Lymphedema Care Program|Undergo HBLCP
16099112|NCT02170259|Other|The suboccipital technique|"The suboccipital technique (ST) aims to release the spasm of the muscles affected in tension-type headaches and in general of suboccipital soft tissues, as they are responsible for the mobility dysfunction of the occiput-atlas-axis joint; this releases the facial restriction of this region. Patients lied on the stretcher, in supine position, with their occiput resting against the physiotherapist's hands. Fingertips slide until contacting the posterior arch of atlas so that it hangs from the fingers. A deep and progressive pressure is applied, perpendicularly to muscle fibers, until the therapist perceives that muscle tone decreases. Approximate duration of ST is 10 minutes and it is performed with patients' eyes closed because of the connection between craniocervical muscle tone and eye movements"
16099113|NCT02170259|Other|The articulatory technique|The articulatory technique (AT) was administered to correct and restore the mobility of joints between occiput, atlas and axis - correcting a global joint dysfunction. This technique was performed in supine position, in the same manner as the preceding technique, bilaterally and in two phases. First, a gentle head decompression is applied, followed by small circumduction searching for the joint barrier in rotation through selective tension. Second, the manipulation is performed by a cranial rotation towards the same side as the circumduction and around a vertical axis passing through the axis, without cervical flexion or extension and very little bending
16099114|NCT02170259|Other|Combined treatment|Combined treatment (ST and AT). Combination treatment consisted of the application of the two preceding treatments in the same sequence: first, treatment with ST and then AT, thereafter maintaining the resting position for five minutes
16099115|NCT02170246|Drug|Telmisartan|
16099116|NCT02170220|Drug|Vortioxetine|Vortioxetine tablets
16099117|NCT02170207|Drug|Lansoprazole|Lansoprazole 30 mg injection
16099118|NCT02170194|Behavioral|Resilience Enhancement Training via Smart Phone|
16099119|NCT02170194|Behavioral|Daily Text Messages|
16099120|NCT02170181|Radiation|SBRT|SBRT to Oligometastases
16099121|NCT02170168|Other|integrated palliative care program|a standardised care pathway, an educational programme and information to general public, patients and their carers
16099122|NCT02170142|Device|MRI|non-invasive MRI techniques (DTI) and (ASL) will be used to assess normal brain development. DTI is capable of invasively delineating macroscopic anatomic components with high contrast and revealing structures at the microscopic level. ASL is capable of measuring cerebral blood flow and cerebral metabolic rate of oxygen.
16099123|NCT02170129|Device|50% AAB plus 50% autologous bone|"All patients were evaluated clinically and their medical histories were recorded. Preliminary screening, including the acquisition of intraoral and panoramic radiographs, was performed to evaluate potential patients' eligibility. Patients who met the selection criteria received oral hygiene instructions and debridement, if required, after which bone volumes were analysed using cone-beam computed tomography (CBCT; Imaging Sciences International, Hatfield, PA, USA).
~A staged approach was carried out at all sites. Thus, sinus lift grafting procedures were followed by implant placement 7-8 months later.
~Both groups received tapered implants with an anodised surface."
16099124|NCT02170129|Device|100% AAB|"All patients were evaluated clinically and their medical histories were recorded. Preliminary screening, including the acquisition of intraoral and panoramic radiographs, was performed to evaluate potential patients' eligibility. Patients who met the selection criteria received oral hygiene instructions and debridement, if required, after which bone volumes were analysed using cone-beam computed tomography (CBCT; Imaging Sciences International, Hatfield, PA, USA).
~A staged approach was carried out at all sites. Thus, sinus lift grafting procedures were followed by implant placement 7-8 months later. Both groups received tapered implants with an anodised surface."
16099125|NCT02170116|Drug|BIBR 1048 MS dose 1|
16099126|NCT02170116|Drug|BIBR 1048 MS dose 2|
16099127|NCT02170116|Drug|BIBR 1048 MS dose 3|
16099128|NCT02170116|Drug|BIBR 1048 MS dose 4|
16099129|NCT02170116|Drug|BIBR 1048 MS dose 5|
16099130|NCT02170116|Drug|Placebo to BIBR 1048 MS|
16099131|NCT02170103|Procedure|percutaneous intervention (PCI)|
16099132|NCT02170103|Drug|Microbubbles|The agents will be divided into two separate doses (two vials per study), and mixed with approximately 29 milliliters of saline (approximately a 2.0-4.0% infusion). The first dilution will be administered pre PCI therapy, and the second dilution infused immediately post PCI. Since Optison is less stable in saline, an alternative approach will be to give the Optison as intermittent 0.1 milliliter boluses followed by 3-5 saline flushes over 10 seconds. The entire duration of each treatment before PCI will be up to 30 minutes depending on time constraints in getting to the catheterization laboratory, while the duration of treatment immediately after PCI will be 30 minutes.
16099133|NCT02170103|Procedure|Ultrasound|Intermittent high MI (Mechanical Index) impulses (0.8-1.4 MI; Frequency 1.0-1.7 MHz;pulse duration 4-44 microseconds) will be administered over the microvasculature where there are wall motion abnormalities and a perfusion defect using an imaging plane that best aligns itself with the risk area
16099134|NCT02170090|Drug|Gemcitabine|Gemcitabine 1000mg/m2
16099135|NCT02170090|Drug|Cisplatin|Cisplatin 25mg/m2
16099136|NCT02170090|Drug|Capecitabine|Capecitabine 1250mg/m2
16099137|NCT02170077|Drug|BIA 2-093|BIA 2-093 (tablets) administered at increasing daily doses of 400 mg, 800 mg and 1200 mg once-daily or twice-daily, oral route
16099138|NCT02170077|Drug|Placebo|Placebo tablets administered orally
16099139|NCT02170064|Drug|BIA 2-093 (Eslicarbazepine acetate)|Eslicarbazepine acetate administered at increasing daily doses of 5 mg/kg, 15 mg/kg, and 30 mg/kg (or 1800 mg, whichever less); once-daily; oral route
16099140|NCT02170051|Behavioral|CBSST-CCT|
16099141|NCT02170051|Behavioral|Goal focused supportive contact|
16099142|NCT02170038|Drug|Microgynon|Subjects will receive 21 daily oral doses of Microgynon tablets containing 0.15 mg levonorgestrel und 0.03 mg ethinylestradiol.
16099143|NCT02170038|Drug|Noristerat(BAY86-6308)|Subjects will receive one intramuscular dose of Noristerat (oily solution for intramuscular injection) containing 200 mg norethisterone enantate.
16099144|NCT02170025|Drug|Riociguat (Adempas, BAY63-2521)|Participants received 0.5 mg BAY63-2521 three times daily (tid) for 14 days. The dose would be increased to 1 mg BAY63-2521 for an additional 14 days, if this was considered safe and tolerable on the basis of the available data for a given patient.
16099145|NCT02170025|Drug|Placebo|Participants received matching placebo tid.
16099146|NCT02170012|Drug|PF-06743649|20 mg tablet once daily dosing for 14 days
16099147|NCT02170012|Drug|Placebo|Placebo tablet once daily dosing for 14 days
16099148|NCT02170012|Drug|PF-06743649|To be decided dose, tablet once daily dosing for 14 days
16099149|NCT02170012|Drug|Placebo|Placebo tablet once daily dosing for 14 days
16099150|NCT02170012|Drug|PF-06743649|To be decided dose, tablet once daily dosing for 14 days
16099151|NCT02170012|Drug|Placebo|Placebo tablet once daily dosing for 14 days
16099152|NCT02170012|Drug|PF-06743649|To be decided dose, tablet once daily dosing for 14 days
16099153|NCT02170012|Drug|Placebo|Placebo tablet once daily dosing for 14 days
16099154|NCT02170012|Drug|PF-06743649|To be decided dose, tablet once daily dosing for 14 days
16099155|NCT02170012|Drug|Placebo|Placebo tablet once daily dosing for 14 days
16099156|NCT02169999|Other|Personalized Diabetes Care Website|Subjects enrolled in the intervention view the Personalized Diabetes Care website and enter their self-reported medical history and personal preferences into the website. A model runs and creates a 2 page print out with risk estimates for the subject to review with their physician.
16099157|NCT02169986|Behavioral|electronic reminders|
16099158|NCT02169973|Drug|JNJ-42165279|Participants will receive oral suspension of JNJ-42165279 in Part B as single dose on Day 1 (100 mg) and on Day 8 (up to 250 mg); in Part C as once daily dose (up to 100 mg) from Day 1 to Day 7.
16099159|NCT02169973|Drug|11C-MK-3168|Participants will receive 11C-MK-3168 in the target range of 185 to 370 megabecquerel (MBq) intravenously (into a vein) before every positron emission tomography scan in Parts A, B, and C.
16099160|NCT02169960|Behavioral|Smart, Positive, Active, Realistic X-factor thoughts (SPARX)|Cognitive Behavioral Therapy based online intervention for depression
16099161|NCT02169960|Behavioral|Breaking Free|Online based intervention for Drug and Alcohol Use
16099162|NCT02169960|Behavioral|This Way Up|Cognitive Behavioral Therapy online intervention for Depression and Anxiety
16099163|NCT02169960|Behavioral|Resiliency Training|Op Volle Kracht (OVK)
16099164|NCT02169947|Behavioral|Weight loss core|The weight loss core is a culturally adapted version of the Diabetes Prevention Program core 16 week session program.
16099165|NCT02169947|Behavioral|Weight loss core plus maintenance|The intervention is a culturally adapted version of the Diabetes Prevention Program core 16 sessions plus 12 maintenance sessions.
16099166|NCT02169934|Drug|Radiolabeled TRV130|A single 2 mg IV dose administered as a 10 mL manual IV push over 2 minutes
16099167|NCT02169921|Device|Atherectomy Catheter|"Atherectomy Catheter, TurboHawk, is used for Angioplasty. Spider FX can concomitantly be used with TurboHawk.
~TurboHawkTM LS-C, TurboHawk LX-C, TurboHawk SS-CL and TurboHawk SX-C are participated in this arm."
16099168|NCT02169908|Device|Thermotest|
16099169|NCT02169908|Device|von Frey hairs|
16099170|NCT02169895|Drug|BIA 9-1067|
16099171|NCT02169895|Drug|Placebo|
16099172|NCT02169895|Drug|Prolopa®|levodopa/benserazide 100/25 mg
16099173|NCT02169882|Drug|Placebo|"Patients receiving 450 mg rifampicin will receive additional 2 placebo tablets, while those who receive 900 mg rifampicin will receive 1 placebo tablet.
~Patients receiving 1350 mg rifampicin will not receive any placebo tablet.
~With this arrangement, every subject will receive 3 tablets of study drugs."
16099174|NCT02169882|Drug|Rifampicin|"Patients in experimental arms will receive either 1 or 2 additional tablets of rifampicin.
~Placebo tablets will be added accordingly, so that every study subject will receive 3 tablets of rifampicin plus placebo as described in the Arms section."
16099175|NCT02169882|Drug|Other TB drugs|"Along with study drug and placebo, patients will receive other oral TB drugs (INH, Ethambutol, and Pyrazinamide) and pyridoxin, in accordance to National TB Program guidelines for 6 months.
~Unconscious subjects will receive oral drugs via nasogastric tubes (NGT)"
16099176|NCT02169882|Drug|Adjuvant dexamethasone|Patients will receive dexamethasone in decreasing dose (in 6-8 weeks, according to TBM severity grade on admission)
16099177|NCT02169869|Device|Mirena|A radio-opaque T-shaped polyethylene device containing 52mg of levonorgestrel dispersed in polydimethylsiloxane on its stem. The progestin is released at a rate of 15 mcg per day.
16099178|NCT02169869|Device|Paragard|A T-shaped polyethylene device with 380 mm2 of exposed surface area of fine copper wire wound around its arms and stem. Barium sulfate has been added to the polyethylene frame to make the device radio-opaque. A 3-mm plastic ball is located at the base of the IUD, through which the polyethylene monofilament string passes.
16099179|NCT02169856|Behavioral|EFTs (emotional freedom techniques)|The Emotional Freedom Techniques (EFTs) which has been pioneered by Gary Craig is a form of alternate medicine which works by tapping on body energy meridian points. Unlike drugs the EFTs has no side effects too
16099180|NCT02169856|Drug|Tab. Midazolam 7.5 mg|Tab. Midazolam 7.5 mg will be given to all patients at night before surgery.
16099181|NCT02169856|Drug|Inj. Midazolam 0.7mg/kg|Inj . Midazolam 0.7 mg/kg given as premedication 45 min before surgery.
16099182|NCT02169856|Drug|Inj. Propofol 2.5mg/kg|It was given to induce anesthesia after 3 min of pre oxygenation.
16099183|NCT02169856|Drug|Inj. Atracurium 0.5 mg/kg|It was given to induce muscle relaxation during anesthesia
16099184|NCT02169856|Drug|Sevoflurane 2.5 vol %|It was given to maintain anesthesia during surgery alongwith oxygen in air mixture
16099185|NCT02169856|Drug|Inj. Cefuroxime 1.5 g IV|It was given as prophylactic antibiotic. 2 doses given. 1st 30-60 min before surgery. 2nd 6 hours after surgery
16099186|NCT02169856|Drug|Drug: Inj. Ketorolac 30 mg IV|3 doses for analgesia. 1st immediate postoperative, 2nd at 8 hours postoperative and 3 rd at 16 hours postoperative period
16099187|NCT02169856|Drug|Inj. Zantac 50mg IV|2 doses. 1st at immediate postoperative and 2nd 12 hours after surgery
16099188|NCT02169843|Drug|Sevoflurane|inhale Sevoflurane
16099189|NCT02169843|Drug|Dexmedetomidine|intravenous pumping Dexmedetomidine 0.2µg/kg/h
16099190|NCT02169843|Drug|Placebo(for Dexmedetomidine)|normal saline mimic Dexmedetomidine, intravenous pumping 0.05ml/kg/h
16099191|NCT02169830|Drug|nortriptyline|The nortriptyline will be given in an escalating fashion, starting at 25 mg PO qhs for 2 weeks, followed by 50 mg PO qhs for 2 weeks, and finally 75 mg PO qhs. Patients will be encouraged to use the lowest effective dose and to self-titrate their medication.
16099192|NCT02169830|Drug|Topiramate|Topiramate dosing will be 25 mg PO qhs for 1 week, followed by 25 mg BID for 1 week, followed by 25 mg in the morning and 50 mg qhs for 1 week, and finally 50 mg BID
16099193|NCT02169830|Behavioral|Diet Modification|Emphasis will be given to cessation of known migraine triggers such as caffeine, sodas, chocolates, alcohol (especially red wine) and aged cheeses. Patients who have complete control of their symptoms with diet and behavior modification alone will be followed for a total of 4 months to determine the durability of symptom relief.
16099194|NCT02169817|Drug|Bacillus clausii|Pharmaceutical form:aqueous suspension Route of administration: oral
16099195|NCT02169817|Drug|Oral Rehydration Therapy|Pharmaceutical form:vials/sachets for solution Route of administration: oral
16099196|NCT02169804|Drug|Androxal 25 mg|
16099197|NCT02169791|Drug|MLN9708|MLN9708 will be given weekly x 3 weeks every 28 day cycles, for up to 12 cycles starting at D+5 post-transplant.
16099198|NCT02169778|Behavioral|Intermittent energy restricted diet|
16099199|NCT02169778|Behavioral|Continuous energy restricted diet|
16099200|NCT02169765|Other|Hepatic resection|Adequate remnant liver volume was 30% for HCC patients without cirrhosis, and >50% for HCC patients with chronic hepatitis, cirrhosis, or severe fatty liver.
16099201|NCT02169765|Other|Radiofrequency ablation|Radiofrequency ablation is performed in less than one week after clinical diagnosis.
16099202|NCT02169752|Drug|Ambrisentan|"Subjects will be randomized 1:1 ratio according to computer generated random numbers to receive either placebo or ambrisentan 5mg daily for one month followed by 10 mg daily for the 5 months in a double-blinded manner."
16099203|NCT02169739|Device|Ischemic Preconditioning|Patients will undergo ischemic preconditioning once or twice daily for up to four 5-minutes cycles of bilateral upper extremity ischemia separated by 5-minute periods of reperfusion.
16099204|NCT02169726|Device|Diffuse Optical Spectroscopy|Diffuse Optical Spectroscopy Imaging measure blood flow,oxygen, temperature in back muscle when they are treated with therapeutic ultrasound and can improve the treatment
16099205|NCT02169713|Drug|Mirabegron|Oral
16099206|NCT02169713|Drug|Solifenacin succinate|Oral
16099207|NCT02169713|Drug|Tamsulosin HCl|Oral
16099208|NCT02169713|Drug|Placebo|Oral
16099209|NCT02169700|Procedure|Ischemic compression. Dry Needling|Ischemic compression was carried out after dry needling. Dry needling was performed with a solid filament needle. Subjects were asked to lie in a prone position. The MTrP was held firmly in a pincer grasp. Before inserting the needle, the patient was advised about the possible sharp pain and muscle twitching. The needle was inserted perpendicular to the skin. Then, the muscle fibers were repeatedly perforated by rapidly inserting and partially withdrawing the needles from the MTrP until two local twitch responses were elicited from the muscle. On removal of the needle, the area was compressed firmly with a cotton bud for two minutes. Immediately after the needling, subjects were randomly assigned to one of three groups (IC, sham and control).
16099210|NCT02169687|Device|HIFU|High Intensity focalized Ultrasounds
16099211|NCT02169674|Biological|EngerixB, GlaxoSmithKline Vaccines|
16099212|NCT02169661|Other|Burger and Beetroot Study|50% fat, 10% beetroot extract
16099213|NCT02169648|Drug|ranibizumab|intravitreal injection of 0.50 mg (0.05ml) ranibizumab monthly as needed.
16099214|NCT02169635|Procedure|macular buckle|macular buckle with a three-armed silicone capsule
16099215|NCT02169609|Drug|Dinutuximab. Immunotherapy|"Patients will receive 5 courses of Dinutuximab + GM-CSF + IL2 at intervals of 28 days for all courses. In addition, all patients will receive isotretinoin (13-cis-retinoic acid, or RA) at 160 mg/m2/dose twice a day for 14 days every 28 days, for 6 courses.
~Patients come off study if progressive disease develops at any time after cycle 1 or life-threatening grade 4 toxicity occurs clearly attributable to Immunotherapy."
16099216|NCT02169596|Drug|Ticagrelor|Blood tests taken for flow cytometry
16099217|NCT02169596|Other|EndoPAT - endothelial assessment|
16099218|NCT02169583|Drug|GSK1325756 Solution|Solution containing 2 mg/mL GSK1325756 in sterile water for injection, to be administered intravenously.
16099219|NCT02169583|Drug|GSK1325756 Solution Matching Placebo|Solution containing sterile water for injection matching GSK1325756 solution, to be administered intravenously.
16099220|NCT02169583|Drug|GSK1325756 Tablet|A white film coated tablet containing 50 mg GSK1325756 to be administered orally.
16099221|NCT02169583|Drug|GSK1325756 Tablet Matching Placebo|A white film coated tablet matching GSK1325756 tablet, to be administered orally.
16099222|NCT02169570|Dietary Supplement|Vitamin D|
16099223|NCT02169570|Dietary Supplement|Calcium|
16099224|NCT02169570|Dietary Supplement|Placebo Vit D|
16099225|NCT02169570|Dietary Supplement|Placebo Calcium|
16099226|NCT02169557|Drug|Fexinidazole|
16099227|NCT02169544|Drug|Abatacept|
16099228|NCT02169531|Drug|ex vivo Activated Immune Cells|The patients who take medication before the enrollment will be required to reduce at least half the amount of the medication before the treatment. The reduction of the medication will continue during and after the therapy until the levels of plasma hemoglobin A1c (HbA1c) increase to equal or above the levels of the baseline measured before the treatment.
16099229|NCT02169505|Drug|Brentuximab Vedotin|Starting dose: 1.2 mg/kg by vein on Day 1 for the first 2, 21 day cycles. Dose increased to 1.8 mg/kg by vein after the second cycle for all subsequent cycles.
16099230|NCT02169479|Drug|BIA 9-1067|OPC, Opicapone
16099231|NCT02169479|Drug|Placebo|PLC, Placebo
16099232|NCT02169479|Drug|Sinemet® 100/25|Immediate-release levodopa/carbidopa 100/25 mg
16099233|NCT02169466|Drug|BIA 9-1067|OPC, Opicapone
16099234|NCT02169466|Drug|Placebo|PLC, Placebo
16099235|NCT02169466|Drug|Madopar® HBS|controlled-release levodopa 100 mg/benserazide 25 mg
16099236|NCT02169453|Drug|BIA 9-1067|OPC, Opicapone
16099237|NCT02169453|Drug|Placebo|PLC, Placebo
16099238|NCT02169453|Drug|Sinemet® CR 100/25|Controlled-release levodopa/carbidopa 100/25 mg
16099239|NCT02169440|Drug|BIA 9-1067|BIA 9-1067 25 mg
16099240|NCT02169440|Drug|Warfarin|Warfarin 25 mg
16099241|NCT02169427|Drug|OPC|The drug substance of 100 mg OPC was administered as 1 capsule.
16099242|NCT02169414|Drug|BIA 9-1067 5 mg|OPC, Opicapone
16099243|NCT02169414|Drug|BIA 9-1067 25 mg|OPC, Opicapone
16099244|NCT02169414|Drug|levodopa/carbidopa 100/25|immediate (standard) release levodopa/carbidopa 100/25
16099245|NCT02169414|Drug|Placebo|PLC, Placebo
16099246|NCT02169414|Drug|levodopa/benserazide 100/25 mg|immediate (standard) release levodopa/benserazide
16099247|NCT02169401|Device|Implantation with the commercially available Axium Neurostimulator|
16099248|NCT02169388|Drug|Probiotic|Microbial composition using probiotic
16099249|NCT02169388|Drug|placebo（for probiotic）|microbiota modulation using placebo
16099250|NCT02169375|Other|Brain computer Interface Mu (SMR) rhythm|Subjects will wear an EEG cap for 1-2 hours typical per session and use the brain computer interface to operate assistive technology. Subjects will be asked to participate in 10 sessions.
16099639|NCT02166476|Drug|Levofloxacin|Levofloxacin
16099251|NCT02169362|Device|Autologous Platelet Rich Plasma (PRP) Gel (Magellan® Bio-Bandage™)|Application of up to 18 mL of autologous PRP gel (Magellan® Bio-Bandage™) to the surface of an acute deep partial thickness burn wound no greater than 72 cm squared within 72 hours of the initial injury. Intervention is in addition to standard of care treatment. The PRP Bio-Bandage™ is prepared using the Magellan® System and is FDA cleared via BK030040 and BK040068.
16099252|NCT02169349|Other|laboratory biomarker analysis|
16099253|NCT02169349|Other|Next Generation Sequencing|
16099254|NCT02169349|Genetic|DNA Analysis|
16099255|NCT02169336|Drug|Intranasal Dexmedetomidine|
16099256|NCT02169336|Other|Intranasal Placebo|
16099257|NCT02169323|Other|Step-down|Step-down of the inhaled corticosteroid (ICS) dose until discontinuation for 6 months
16099258|NCT02169297|Procedure|Ultrasound-guided Sub-Paraspinal Block|Treatment group received bilateral ultrasound-guided placement of multi-perforated soaker catheter at sub-paraspinal location. Catheter position was considered adequate when live ultrasound imaging confirmed placement directly over the rib surface and lateral to the transverse process at the T2-T10 level. An infusion of ropivacaine 0.2% was started via the On-Q infusion system at a rate of 0.25 mg/kg/hour per catheter (maximum of 8 ml/hr catheter [maximum pump infusion rate]). The local anesthetic infusion was stopped on post-operative day number 3 and the catheters removed.
16099259|NCT02169297|Procedure|PCA only|Patients received intravenous PCA post-operatively
16099260|NCT02169284|Drug|Erlotinib Hydrochloride|Given PO
16099261|NCT02169284|Other|Laboratory Biomarker Analysis|Correlative studies
16099262|NCT02169284|Other|Pharmacological Study|Correlative studies
16099263|NCT02169284|Other|Placebo|Given PO
16099264|NCT02169284|Other|Quality-of-Life Assessment|Ancillary studies
16099265|NCT02169284|Procedure|Therapeutic Conventional Surgery|Undergo TURBT or cystectomy
16099266|NCT02169271|Drug|Aspirin|Given PO
16099267|NCT02169271|Other|Laboratory Biomarker Analysis|Correlative studies
16099268|NCT02169271|Other|Placebo|Given PO
16099269|NCT02169258|Procedure|Systemic Strategy|Significant CAD needing further revascularization is defined as patients who have luminal stenosis > 70% of the major epicardial vessels and bypass graft vessel or their major branches (> 50% for left main trunk or in-stent restenotic lesion) with reference vessel larger than 2.5 mm in diameter and moderate area of vulnerable myocardium for ischemia. Intermediate stenotic lesions should be determined if they are hemodynamic significant by fractional flow reserve (FFR) (<=0.8). The choice of revascularization procedure, either percutaneous coronary intervention or coronary artery bypass surgery, depends on operator's or cardiovascular team's suggestion and patient's decision.
16099270|NCT02169245|Other|Dietary control of protein and fiber intake at breakfast|Participants will be provided breakfast meals for 4, 2 week long interventions. The intervention arms are 1) average protein and fiber, 2) average protein and high fiber, 3) high protein and average fiber, and 4) high protein and fiber.
16099271|NCT02169232|Device|Videolaryngoscope|
16099272|NCT02169232|Device|Fiberoptic|
16099273|NCT02169219|Drug|Glucocorticoids|"Patients will begin prednisone therapy at a dose selected by the investigator or the treating physician with oral prednisone 60mg or 1mg/kg (if weight less than 60kg) or intravenous methylprednisolone, up to 1g/day for three days.
~Prednisone will be tapered over 8 weeks as follows:
~60mg for 2 weeks
~40mg for 2 weeks
~30mg for 1 week
~20mg for 1 week
~10mg for 1 week
~5mg for 1 week"
16099274|NCT02169219|Drug|Rituximab|Rituximab will be administered in four weekly doses at 375mg/m2
16099275|NCT02169206|Radiation|Bilateral shoulder anteroposterior radiography|"Patient standing with the tube in front and 105 cm far from the shoulder radiating perpendicular to the cassette in the back, both arms hanging aside the trunk in 0 degrees of arm abduction, 0 degrees of rotation and 0 degrees of extension with the thumb facing forward to obtain true bilateral shoulder anteroposterior view. Voltage and exposure time differs regarding each person's body mass.
~In the same position, the patient only elevates the arm up to 90 degrees of abduction."
16099276|NCT02169193|Radiation|99mTc-Rhenium Sulfide Nanocolloid|12 MBq of NanoCis added to 500 ml of enteral feeding
16099277|NCT02169180|Drug|Ibrutinib|Participants will receive ibrutinib capsules 560 milligram (mg) orally, once daily on a 28-day cycle up to 7 cycles or until disease progression (or relapse if the participant achieved a complete response [CR]), unacceptable toxicity, or end of treatment, whichever occurs first.
16099278|NCT02169167|Device|Resin salve treatment|Resin is collected in the municipality of Kolari, Finland, from the trunks of full-grown Norway spruce (Picea acies) trees. Bark and other impurities are removed mechanically. The resin is then liquefied and purified by filtering. Resin salve is composed of a 10% (w/w) mixture of purified spruce resin in a standardized salve base. None of the components of the salve base have antibacterial properties. Resin salve is produced from the pure resin to the final product in accordance with the Good Manufacturing Standards (GMP) and it holds the European CE mark (Abilar 10% Resin Salve, Repolar Ltd., Espoo, Finland, CE 0537).
16099279|NCT02169167|Device|Octenidine treatment|Octenidine dihydrochloride is a cationic surfactant and bis-(dihydropyridinyl)-decane derivative, used in concentrations of 0.1-2.0%. It is similar in its action to the quaternary ammonium compounds, but is of somewhat broader spectrum of activity. Octenidine is currently increasingly used in continental Europe as a substitute for quats or chlorhexidine (with respect to its slow action and concerns about the carcinogenic impurity 4-chloroaniline) in water- or alcohol-based skin, mucosa and wound antiseptics. In aqueous formulations, it is often potentiated with addition of 2-phenoxyethanol.
16099280|NCT02169154|Drug|1% Diclofenac Sodium|1% diclofenac sodium
16099281|NCT02169154|Drug|3% Menthol|3% Menthol
16099282|NCT02169154|Drug|0.09% Menthol|0.09% Menthol
16099283|NCT02169154|Drug|0.2% Sodium Lauryl Sulfate|0.2% Sodium Lauryl Sulfate
16099284|NCT02169154|Drug|0.9% Saline|0.9% Saline
16099285|NCT02169141|Other|Pharmacokinetics|multiple blood samples are obtained by means of an indwelling intravenous catheter for calculating PK parameters
16099286|NCT02169115|Drug|Omalizumab|150mg, s.c., every 4 weeks
16099287|NCT02169115|Drug|Omalizumab|300mg, s.c., every 4 weeks
16099288|NCT02169115|Drug|Placebo|Placebo, s.c., every 4 weeks
16099289|NCT02169102|Other|No additional Intervention (control)|No additional intervention previously to the urgency endodontic treatment (Control)
16099640|NCT02166476|Drug|Saline|Saline
16099290|NCT02169102|Radiation|Sham Laser Irradiation|Fifteen minutes previously the urgency endodontic treatment, sham laser irradiation was performed in the tooth with irreversible inflammation in pulp.
16099291|NCT02169102|Radiation|Laser 1 (at 0,16 Joules/point of irradiation)|Fifteen minutes previously the urgency endodontic treatment, laser irradiation will be performed in the tooth with irreversible inflammation in pulp at 0,16 Joules/point at 2 points (perpendicularly to tooth crown and in periapex region)
16099292|NCT02169102|Radiation|Laser 2 (1,6 Joules/point of irradiation)|Fifteen minutes previously the urgency endodontic treatment, laser irradiation will be performed in the tooth with irreversible inflammation in pulp at 1,6 Joules/point at 2 points (perpendicularly to tooth crown and in periapex region)
16099293|NCT02169089|Drug|Spironolactone|Patients will be given Spironolactone 12.5 mg on week 0 (visit 2). Patients will be escalated to 25 mg daily Spironolactone or maximal tolerated dose over a 4-week period. Patients will continue treatment for an additional 48 weeks.
16099294|NCT02169089|Drug|Placebo|Placebo
16099295|NCT02169076|Device|Cardiac Resynchronization Therapy|The cardiac resynchronization therapy of the ICD/Pacemaker device of the patients enrolled in the study will be programed under a standardized protocol and enabled or disabled in a crossover fashion during the study.
16099296|NCT02169063|Radiation|carbon-11 acetate|Given IV
16099297|NCT02169063|Radiation|fluorine F 18 sodium fluoride|Given IV
16099298|NCT02169063|Procedure|positron emission tomography|Undergo 11C-acetate and 18F-fluoride PET
16099299|NCT02169063|Other|laboratory biomarker analysis|Correlative studies
16099300|NCT02169037|Procedure|FIRM Ablation|Substrate ablation for AF, via ablation of rotors and focal sources alone.
16099301|NCT02169037|Procedure|Conventional AF ablation with PVI|Trigger Based Ablation for AF, using Pulmonary Vein Isolation alone.
16099302|NCT02169024|Behavioral|Expect With Me group prenatal care|Expect With Me group prenatal care was designed based on: principles of group care; evidence from RCTs demonstrating improved birth outcomes; ACOG clinical guidelines; and research on patient and provider engagement through technology. Designed with national dissemination as a primary consideration, Expect With Me incorporates best evidence-based aspects of existing models of group care, with a novel IT platform to improve patient engagement and support, enhance health behaviors and decision making, connect providers and patients, and improve health service delivery. Expect With Me provides care to groups of 8-12 women of the same gestational age, implemented after initial individual assessment through delivery. Group visits are 90-120 minutes each, and follow a structured curriculum that incorporates standard content of prenatal care, and emphasizes critical health issues relevant to pregnancy, such as nutrition, physical activity, stress/mental health and sexual health.
16099303|NCT02169024|Other|Standard individual prenatal care|Standard of care- individual prenatal care
16099304|NCT02169011|Procedure|Latissimus Dorsi Flap Reconstruction|Delayed, unilateral breast reconstruction with the LD-flap. The reconstruction will be performed in a standard fashion as specified in the protocol. Implants should be used when required to gain sufficient volume of the breast.
16099305|NCT02169011|Procedure|TAP Flap Reconstruction|Delayed, unilateral breast reconstruction with the TAP-flap. The reconstruction will be performed as specified in the protocol and when implants are required to gain sufficient volume they should be combined with an acellular dermal matrix.
16099306|NCT02168998|Behavioral|Clown|Comparison of routine venipuncture with a distraction technique by a medical clown
16099307|NCT02168985|Behavioral|TFH program|The Faithful House (TFH), is a three-day faith-based skills-building curriculum. The curriculum aims to increase household resilience by strengthening families and couples' relationships through enhanced couple communication
16099308|NCT02168972|Device|Global mapping and ablation device|During the procedure the Globe catheter will be delivered via standard femoral vein access and transseptal puncture. Anatomical and electrophysiological mapping of the LA will be followed by pulmonary vein isolation (PVI) by RF ablation. Additional lesions will be created as deemed appropriate by the investigator.
16099309|NCT02168959|Drug|bupivacaine|This drug is standard of care. The point of the study is to see if this method will yield better pain scores and improved patient satisfaction vs. non-nerve block. Simply: prospective observation of two standard methods.
16099310|NCT02168946|Drug|Vabomere|Vabomere for IV injection, administered as a 2 g/2 g dose
16099311|NCT02168946|Drug|Best Available Therapy|Antibiotic(s) chosen by Investigator
16099312|NCT02168933|Device|308 nm excimer laser|Biweekly treatments with 308 nm excimer laser for a total of 8 weeks
16099313|NCT02168933|Device|Sham laser|Sham laser treatment to the control side biweekly for a total of 8 weeks.
16099314|NCT02168920|Drug|2 mg/day|Once daily for 10 weeks
16099315|NCT02168920|Drug|3 mg/day|Once daily for 10 weeks
16099316|NCT02168920|Drug|6 mg/day|Once daily for 10 weeks
16099317|NCT02168920|Drug|Placebo (0 mg/day)|Once daily for 10 weeks
16099318|NCT02168907|Drug|6,8-bis(benzylthio)octanoic acid|Given IV
16099319|NCT02168907|Drug|bendamustine hydrochloride|Given IV
16099320|NCT02168907|Biological|rituximab|Given IV
16099321|NCT02168907|Other|laboratory biomarker analysis|Correlative studies
16099322|NCT02168894|Procedure|Acupuncture|"Group 1: Acupuncture sessions with electrical stimulation 3 times a week for 4 weeks, for a total of 12 sessions. Then, take a 2 week break. After that, participant randomly assigned to receive 12 sessions of acupuncture with electrical stimulation as before or not have anymore sessions in this study.
~Group 2: Acupuncture sessions without electrical stimulation 3 times a week for 4 weeks, for a total of 12 sessions. Then, will take a 2 week break. After that, participant randomly assigned to receive 12 extra sessions of acupuncture without electrical stimulation or not have anymore sessions in this study.
~Group 3: Acupuncture sessions 3 times per week over 4 weeks for a total of 12 sessions. Participant may or may not have electrical stimulation at these sessions. These sessions will begin 14 weeks after enrollment."
16099323|NCT02168894|Procedure|Nerve Function Tests|Nerve function tests consisting of hand tasks and balance evaluation performed at visit before acupuncture, and at end of study visit.
16099324|NCT02168894|Behavioral|Questionnaires|Questionnaire completion at baseline, visit before acupuncture, after 6th and 12th acupuncture session, and at end of study visit.
16099325|NCT02168881|Drug|Misoprostol|
16099326|NCT02168881|Drug|Dinoprostone|
16099641|NCT02166463|Biological|Bleomycin Sulfate|Given IV or SC
16099327|NCT02168868|Diagnostic Test|Blood Draw|"For children who had recently undergone ASD-directed treatment (≤60 days), a single blood sample (5 mL) will be collected at three independent visits, conducted at 2-month intervals.
~For untreated children, a single venous blood sample (5 mL) will be drawn from all subjects (ASD and control children).
~For mothers, a single venous blood sample (5 mL) will be drawn."
16099328|NCT02168868|Diagnostic Test|Stool Sample Collection|Subjects (ASD and TDs as control children) will be provided a dry, plastic, screw-top specimen container and will be asked to collect a stool sample at home.
16099329|NCT02168868|Diagnostic Test|Urine Sample Collection|Subjects (ASD and TDs as control children) will be provided a dry, plastic, screw-top specimen container and will be asked to collect a urine sample at home.
16099330|NCT02168855|Drug|active nicotine gum|2 mg, standard over-the-counter nicotine replacement therapy gum
16099331|NCT02168855|Behavioral|Standard behavioral therapy|Standard behavioral therapy for smoking cessation
16099332|NCT02168842|Drug|Isradipine|Oral capsules Isradipine IR, up to 10 mg, taken twice daily
16099333|NCT02168842|Drug|Placebo (for Isradipine)|Sugar Pill manufactured to look like Isradipine but has no active ingredients
16099334|NCT02168829|Drug|Rivaroxaban|
16099335|NCT02168829|Drug|Acetylsalicylic acid|
16099336|NCT02168816|Drug|Intravenous Antibacterial Agent|Individuals in this arm receive an intravenous antibacterial agent. They are not assigned to specific medications. Individuals in this arm will receive an intravenous antibacterial agent as determined by their primary healthcare provider. This therapy is usually one of the following intravenous medications: (i) piperacillin/tazobactam (Zosyn), (ii) cefepime, (iii) metronidazole, (iv) aztreonam, (v) vancomycin, (vi) daptomycin, (vii) linezolid (Zyvox), and/or (viii) meropenem.
16099337|NCT02168816|Drug|Oral Antibacterial Agent|Individuals in this arm receive an oral antibacterial agent. They are not assigned to specific medications. Individuals in this arm will receive an oral antibacterial agent as determined by their primary healthcare provider. This therapy is usually one of the following oral medications: (i) sulfamethoxazole/trimethoprim (SMX-TMP), (ii) clindamycin (Clindesse), (iii) linezolid (Zyvox), (iv) moxifloxacin (Avelox), (v) ciprofloxacin (Cetraxal), and/or (vi) metronidazole (Flagyl)
16099338|NCT02168803|Drug|Evacetrapib|Administered orally
16099339|NCT02168790|Device|Amniotic membrane ring|The amniotic membrane ring system (AmnioClip) is device for sutureless application of amniotic membrane to oculare surfaces. Amniotic membrane is mounted between the two rings with a specially designed, accessory mounting device.
16099340|NCT02168777|Drug|Refametinib (BAY86-9766)|"Refametinib twice daily (b.i.d.) in combination with intermittent regorafenib once daily (q.d.) at the assigned dose level.
~In Phase 2, the recommended Phase 2 dose (RP2D) for refametinib-regorafenib combination therapy will be used."
16099341|NCT02168777|Drug|Regorafenib (Stivarga, BAY73-4506)|"Refametinib twice daily (b.i.d.) in combination with intermittent regorafenib once daily (q.d.) at the assigned dose level.
~In Phase 1b dose escalation, regorafenib will be administered in a 3-weeks-on / 1-week-off schedule except in one cohort, that uses regorafenib 2 weeks on / 2 weeks off regimen (dose level -2). In Phase 2, the recommended Phase 2 dose (RP2D) for refametinib-regorafenib combination therapy will be used."
16099342|NCT02168764|Device|ATI Neurostimulation System|All subjects will be implanted with the ATI Neurostimulator which, along with the ATI Remote Controller, provides electrical stimulation.
16099343|NCT02168751|Drug|propofol|
16099344|NCT02168751|Drug|Sevoflurane|
16099345|NCT02168738|Drug|13-C labeled AceDoPC-DHA|"Each subject will receive a single dose of either lipid sequentially (according to randomization) a triglyceride (TG-DHA), a phospholipid (PC-DHA) or acetylated lysophosphatidylcholine (AceDoPC) labeled with 13C.
~The dose contains 50 mg 13C-DHA. The wash-out period is four months"
16099346|NCT02168738|Drug|13-C labeled TG-DHA|"Each subject will receive a single dose of either lipid sequentially (according to randomization) a triglyceride (TG-DHA), a phospholipid (PC-DHA) or acetylated lysophosphatidylcholine (AceDoPC) labeled with 13C.
~The dose contains 50 mg 13C-DHA. The wash-out period is four months"
16099347|NCT02168738|Drug|13-C labeled PC-DHA|"Each subject will receive a single dose of either lipid sequentially (according to randomization) a triglyceride (TG-DHA), a phospholipid (PC-DHA) or acetylated lysophosphatidylcholine (AceDoPC) labeled with 13C.
~The dose contains 50 mg 13C-DHA. The wash-out period is four months"
16099348|NCT02168725|Drug|briciclib|
16099349|NCT02168712|Other|Moderate continuous exercise training|
16099350|NCT02168712|Other|Interval exercise training|
16099351|NCT02168699|Other|Ultrasound examination of the axilla|
16099352|NCT02168686|Genetic|ADVM-043|Gene transfer vector administration
16099353|NCT02168660|Drug|Vitamin D3|Vitamin D3, liquid formulation, 5000 IU/mL.
16099354|NCT02168647|Behavioral|Behavioral Lifestyle counseling|Participants in the intervention group will take part in one-on-one visits with a registered dietitian nutritionist (RDN) from no later than week 14 to child birth at the OBGYN clinic where the participant receives her routine prenatal care or the Nutrition Wellness Research Center in the Iowa State Research Park. These visits will be coordinated with her routine prenatal appointment; therefore a minimum of 6 face-to-face meetings will occur. The counseling sessions will focus on appropriate weight gain during pregnancy through the use of an individualized meal plan, physical activity goals, and behavioral modification. Weight gain will be plotted on an IOM weight gain chart and discussed with study RDN.
16099355|NCT02168647|Other|Control|Participants in the control arm will receive no form of lifestyle intervention. Women will be provided with usual care by their physician. Participants in the control arm will have their weight gain plotted on an IOM growth chart and sent electronically by research staff after each routine prenatal appointment. No other feedback on weight gain or behavior modification will be provided by the study RDN.
16099356|NCT02168634|Drug|Botulinum Toxins|5U botulinum toxin in 1c.c. normal saline, local injection
16099357|NCT02168634|Drug|Placebo|1cc normal saline, local injection
16099358|NCT02168621|Procedure|Full-mouth ultrasonic debridement|Motivation and instruction in proper oral hygiene. Before initiation of the subgingival debridement the patient must show sufficient self-performed infection control (full-mouth plaque score <30%). One session of full-mouth ultrasonic pocket/root debridement using a piezoceramic ultrasonic instrument.
16099391|NCT02168361|Drug|Simeprevir|150 mg daily orally along with pegylated interferon and sofosbuvir for a total of 12 weeks
16099359|NCT02168621|Procedure|Section-wise scaling and root planing|Conventional treatment approach comprising motivation, oral hygiene instructions and section-wise scaling and root planing at required number of consecutive appointments with 1-2 week interval.
16099360|NCT02168608|Other|Remote ischemia precondition|Three cycles of 5-min ischemia/5-min reperfusion induced by a blood pressure cuff placed on the right upper arm served as RIPC stimulus.
16099361|NCT02168608|Other|None remote ischemia precondition|Placed an uninflated cuff on the right upper arm for 30 min.
16099362|NCT02168595|Drug|GMI-1271|GMI-1271 is a potent, rationally designed glycomimetic E-selectin antagonist
16099363|NCT02168595|Drug|Placebo|
16099364|NCT02168582|Behavioral|physiotherapy as usual in primary care|
16099365|NCT02168569|Drug|Coartem™ (Artemether-lumefantrine combination)|AL (Coartem™) was administered twice daily for three days (six doses in total) with dosage determined according to body weight: one tablet (20mg artemether and 120mg lumefantrine) for children 5 to <15kg, two tablets per dose for those 15 to <25kg, and three tablets per dose for those 25 to <35kg.
16099366|NCT02168569|Drug|Coarsucam™ (Amodiaquine-artesunate combination)|AQ-AS (Coarsucam™) was administered once daily according to body weight: one 25mg artesunate and 67.5mg amodiaquine tablet in children <9kg, one 50mg artesunate and 135mg amodiaquine tablet in children 9-17.9kg; and one 100mg artesunate and 270mg amodiaquine tablet in children >18-35kg.
16099367|NCT02168556|Behavioral|Music|Subject listens to music that is 60bpm while undergoing urodynamic testing.
16099368|NCT02168556|Behavioral|Video|Subject watches an informational video prior to undergoing urodynamic testing.
16099369|NCT02168556|Other|Standard of care|Standard of care
16099370|NCT02168543|Drug|Alendronate|
16099371|NCT02168543|Drug|Placebo|
16099372|NCT02168530|Drug|placebo|matching placebo administered daily orally
16099373|NCT02168530|Drug|vismodegib|vismodegib 150 mg administered daily orally
16099374|NCT02168491|Drug|Lixisenatide|Patients will be switched to basal insulin glargine (Lantus, once daily in the morning) and GLP-1 receptor agonist Lixisenatide (Lyxumia, once daily in the morning before breakfast; days 1-14 10 µg thereafter 20 µg). The (mean) daily dose of premixed insulin will be calculated based on the records of the run in period. The initial dose of insulin glargine will be adjusted at about 60% of the daily insulin dose of premixed insulin. This is based on the observed reduction of required insulin dose described in recent literature upon initiation with a GLP-1 agonist.
16099375|NCT02168491|Drug|Insulin glargine|Patients will be switched to basal insulin glargine (Lantus, once daily in the morning) and GLP-1 receptor agonist Lixisenatide (Lyxumia, once daily in the morning before breakfast; days 1-14 10 µg thereafter 20 µg). The (mean) daily dose of premixed insulin will be calculated based on the records of the run in period. The initial dose of insulin glargine will be adjusted at about 60% of the daily insulin dose of premixed insulin. This is based on the observed reduction of required insulin dose described in recent literature upon initiation with a GLP-1 agonist.
16099376|NCT02168478|Drug|Neo-Synalar Cream|Approximately 0.2 g of test material is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.
16099377|NCT02168478|Other|Sodium Lauryl Sulfate Aqueous Solution (0.40%)|Approximately 0.2 ml of the positive , 0.40% aqueous solution of sodium lauryl sulfate is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.
16099378|NCT02168478|Other|Saline|Saline is applied to the absorbent pad portion of a semi-occlusive dressing and applied as received to the upper back between the scapulae. The patches are applied to a designated treatment site and allowed to remain in direct skin contact for a period of 48 hours.
16099379|NCT02168465|Behavioral|teaching self-management of an intermittent catheter|Specifically, we will teach awareness, self-monitoring and self-management strategies to CIC uses with SCI in an online format. Nurse telephone consultation for teaching self-management will be combined with peer leaders for online forums.
16099380|NCT02168452|Procedure|sentinel lymph node biopsy(SLNB)|"incision will be made over the skin site that had fluorescence lymphatic flow which visualized using fluorescence imaging camera and gamma probe.
~double check after removal of the sentinel lymph node
~sending frozen biopsy"
16099381|NCT02168439|Drug|Dexmedetomidine|
16099382|NCT02168439|Drug|Midazolam|
16099383|NCT02168426|Procedure|Guardix|Applying 6g of guardix during abdominal surgery
16099384|NCT02168426|Procedure|Seprafilm|Applying 1 sheet of seprafilm during abdominal surgery
16099385|NCT02168400|Device|Transcranial Direct Current Stimulation (tDCS)|tDCS will be performed with Neuroelectrics Starstim Enobio 20, a non-invasive investigational device that has been labeled as a non-significant risk device by the FDA. This study is regulated by the FDA as an Abbreviated IDE. It has built-in safety mechanisms which allow for immediate cessation of stimulation if the subject becomes uncomfortable. The current will be administered via two electrode sponges for 25 mins with 1-2 milliamperes. These administration protocols are in line with protocols that have outlined safe administration (Nitsche 2007; 2008). No side-effects have been reported with the exception of slight itching under the electrode and occasional occurrence of headache, fatigue, or nausea (Poreisz 2007). Electrodes placement: dorsolateral prefrontal cortex (DLPFC); cathode on left DLPFC, anode on right DLPFC.
16099386|NCT02168387|Device|continuous high frequency oscillator (CHFO)|
16099387|NCT02168387|Drug|Acetylcysteine|
16099388|NCT02168387|Drug|dornase alfa|
16099389|NCT02168374|Other|Indirect pulp treatment|Carious dentine was sampled from the mesial portion of the cavity floor and the pulpal wall was entirely covered with one of the randomly selected materials: GIC containing 4.5% DOX; GIC containing 1.25% CHX or GIC as a control group. The antimicrobial concentrations were chosen based in the previous in vitro results obtained in this study. The cavities were then temporarily restored using a conventional GIC. Within 3 months after the initial treatment,the materials were carefully and completely removed, a new dentine sample was collected, and the teeth were then restored with a light-cured composite resin using a bonding system, after a new placement of the initial liner material.
16099390|NCT02168361|Drug|Pegylated Interferon alfa-2b|1.5 ugm/kg/week subcutaneously injected along with ribavirin and sofosbuvir for 12 weeks total
16099392|NCT02168361|Drug|Ribavirin|1000-1200 mg daily divided twice daily for 12 weeks in combination with pegylated interferon and sofosbuvir
16099393|NCT02168361|Drug|Sofosbuvir|12 weeks of combination sofosbuvir and simeprevir
16099394|NCT02168348|Other|biological examination at consultations at 3 and 6 months|
16099395|NCT02168335|Other|OrasaltsTM|OrasaltsTM mouthwash is composed of 119.5g of natural sea salt, Arnica montana 30C, Echinacea angustifolia 30C, Staphysagria 30C, Phosphorus 30C, Hepar sulphuris 30C, 0.27g cinnamon and 0.27g of liquorice
16099396|NCT02168335|Other|Sea salt|Unmedicated sea salt
16099397|NCT02168322|Device|collagen membrane|bovine collagen membrane used for selective tissue regeneration
16099398|NCT02168322|Device|collagen membrane|collagen bovine occlusive membrane for selective tissue regneration
16099399|NCT02168309|Drug|Labetalol|Titrate up for blood pressure control
16099400|NCT02168309|Drug|Nifedipine|Titrate up to achieve blood pressure control
16099401|NCT02168296|Dietary Supplement|Plant-based ingredient added to starchy meal|
16099402|NCT02168296|Dietary Supplement|Plant-based ingredient added to liquid|
16099403|NCT02168296|Dietary Supplement|No Plant-based ingredient|
16099404|NCT02168283|Combination Product|treatment arm|Hypertonic peritoneal dialysis cycles
16099405|NCT02168283|Behavioral|Control arm|Dietary counseling
16099406|NCT02168270|Dietary Supplement|ascorbic acid|Given IV
16099407|NCT02168270|Drug|temozolomide|Given PO
16099408|NCT02168270|Other|quality-of-life assessment|Ancillary studies
16099409|NCT02168270|Other|laboratory biomarker analysis|Correlative studies
16099410|NCT02168257|Device|RAM Cannula|
16099411|NCT02168257|Device|Binasal Prong CPAP|
16099412|NCT02168244|Other|Heating Pack|Application of heat to skin for 2-3 minutes prior to injection of biologic drug
16099413|NCT02168244|Other|Ice pack|Application of cold to skin for 2-3 minutes prior to injection of biologic drug
16099414|NCT02168231|Procedure|Complex abdominal wall repair Strattice|Not applicable (cross-sectional data from a cohort selected after initial complex abdominal wall surgery with Strattice)
16099415|NCT02168218|Other|7-day overfeeding|7-day overfeeding with an excess sucrose intake corresponding to 40% total energy requirements
16099416|NCT02168205|Drug|Pomalidomide|Capsules
16099417|NCT02168205|Other|Caffeine|Capsules
16099418|NCT02168205|Other|Tobacco|Cigarettes
16099419|NCT02168192|Behavioral|Simulation-Debrief|Subjects underwent a formal debrief, reviewing the BBN skills exhibited in their prior simulation of an obstetrical communication skills scenario.
16099420|NCT02168192|Behavioral|Traditional lecture|Control group underwent lecture for approximately 10 minutes reviewing BBN skills.
16099421|NCT02168179|Procedure|dermatologic complications management/prevention|Apply KeraStat Skin Therapy topically
16099422|NCT02168179|Other|questionnaire administration|Ancillary studies
16099423|NCT02168166|Behavioral|Executive Function Training|
16099424|NCT02168166|Behavioral|Placebo|Placebo version of executive function training
16099425|NCT02168153|Other|Chiropractic Manipulative Therapy|Participants will receive chiropractic spinal manipulative therapy consisting of High velocity low amplitude (HVLA) spinal manipulative procedures. These procedures are typically associated with a quick manual thrust and a cavitation sound. For the cervical spine, a procedure called a cervical index pillar push, thoracic manipulation will occur with unilateral or bimanual contacts in the prone or supine positions and lumbar/pelvis manipulation will be performed with a procedure referred to as side-lying or side-posture.
16099426|NCT02168153|Other|Wait-list|Participants randomized to the wait-list control group will complete questionnaires and perform the same study procedures as those randomized to the chiropractic manipulative therapy arm. After completing the required 2-week waiting period, those who wish to receive chiropractic manipulative therapy will be eligible to schedule treatment visits.
16099429|NCT02168127|Drug|Drug: PRC-063|Methylphenidate Hydrochloride Extended-Release Capsules
16099430|NCT02168127|Drug|PRC-063|Methylphenidate Hydrochloride Extended-Release Capsules
16099431|NCT02168114|Other|Exercising|This arm will only include subjects that have a confirmed diagnosis of Duchenne Muscular Dystrophy. Subjects in this arm will not undergo any exercising, and will only be imaged by Optical and Magnetic Resonance Imaging and Spectroscopy techniques at a single time point.
16099432|NCT02168114|Procedure|Optical and Magnetic Resonance Imaging and Spectroscopy|This arm will contain subjects that are not affected by Duchenne Muscular Dystrophy. These subjects will undergo concentric exercising of one forearm, and eccentric exercising of the contralateral forearm. Two days following the exercising, subjects will undergo Optical Imaging and Magnetic Resonance Imaging and Spectroscopy.
16099433|NCT02168101|Drug|MLN9708|"Patients will be enrolled between Days 45 and 120 after allogeneic transplant and will receive MLN9708 orally (PO) as monotherapy on Days 1, 8, and 15 of each 28-day cycle for 6 cycles. Up to 18 patients will be enrolled in a dose-escalation phase to determine the maximum tolerated dose (MTD).
~Dose-Escalation Phase: MLN9708 will be administered orally (PO) as monotherapy. Dosing will start at 2.3 mg. If acceptable tolerability is demonstrated, escalations will be made to 3 mg and to a maximum-planned dose (MPD) of 4 mg."
16099434|NCT02168075|Drug|0.25g/kgof 20% mannitol|When the neurosurgeon starts the drilling of skull, 0.25g/kg of 20% mannitol administered through the IV catheter with fulldrip. Neurosurgeon evaluate the degree of brain relaxation after dura opening in 4 point scale ( 1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed).
16099435|NCT02168075|Drug|0.5g/kg of 20% mannitol|When the neurosurgeon starts the drilling of skull, 0.5g/kg of 20% mannitol administered through the IV catheter with fulldrip. Neurosurgeon evaluate the degree of brain relaxation after dura opening in 4 point scale ( 1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed).
16099436|NCT02168075|Drug|1.0g/kg of 20% mannitol|When the neurosurgeon starts the drilling of skull, 1.0g/kg of 20% mannitol administered through the IV catheter with fulldrip. Neurosurgeon evaluate the degree of brain relaxation after dura opening in 4 point scale ( 1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed).
16099611|NCT02166736|Device|iFR|Treatment guided by Instantaneous wave-free ratio (iFR®)
16099437|NCT02168075|Drug|1.5g/kg of 20% mannitol|When the neurosurgeon starts the drilling of skull,1.5g/kg of 20% mannitol administered through the IV catheter with fulldrip. Neurosurgeon evaluate the degree of brain relaxation after dura opening in 4 point scale ( 1=bulging brain, 2=firm brain, 3-satisfactorily relaxed, 4=perfectly relaxed).
16099438|NCT02168062|Behavioral|Behavioral Dietary Intervention|Receive individualized nutrition counseling
16099439|NCT02168062|Other|Counseling|Receive individualized symptom management service counseling
16099440|NCT02168062|Other|Educational Intervention|Review educational modules
16099441|NCT02168062|Behavioral|Exercise Intervention|Receive individualized exercise counseling
16099442|NCT02168062|Drug|Goserelin Acetate|Given SC
16099443|NCT02168062|Other|Laboratory Biomarker Analysis|Correlative studies
16099444|NCT02168062|Drug|Leuprolide Acetate|Given SC or IM
16099445|NCT02168062|Other|Quality-of-Life Assessment|Ancillary studies
16099446|NCT02168062|Drug|Triptorelin Pamoate|Given IM
16099447|NCT02168049|Device|Integrated CardioRespiratory System|Participants will be asked to wear a non-invasive band on their upper abdomen while laying down. This band includes acoustic sensors. A remote monitoring device will continuously monitor and record heart rate and lung volumes and function.
16099448|NCT02168049|Device|Transthoracic Echocardiography (TTE)|Participants will undergo a TTE examination. During the TTE, a technician obtains views of the heart by moving a small instrument called a transducer to different locations on the chest or abdominal wall.
16099449|NCT02168049|Device|Electrocardiography|Participants will also have ECG monitoring as part of the TTE exam, which records the electrical activity of the heart using electrodes placed on the body.
16099450|NCT02168023|Device|DACC impregnated dressing|DACC impregnated dressing Sorbact Surgical Dressing ® (ABIGO Medical AB, Sweden) placed over post-caesarean wound after skin closure, the dressing will be removed after the first 48 hours postoperatively
16099451|NCT02168023|Device|Standard surgical dressing|Standard surgical dressing placed over post-caesarean wound after skin closure, the dressing will be removed after the first 48 hours postoperatively
16099452|NCT02168010|Drug|Analgecine|Analgesic drug under test
16099453|NCT02168010|Drug|Neurotropin|Analgesic drug as positive control
16099454|NCT02168010|Drug|Placebo|Blank tablet as placebo.
16099455|NCT02167971|Other|Active Coil|The patients will undergo 10 sessions (2,000 pulses each, lasting 20 minutes) of repetitive transcranial magnetic stimulation over the left dorsolateral prefrontal cortex with the following parameters: 10Hz, 50 trains (40 pulses on each train), biphasic wave, 25 seconds between the trains.
16099456|NCT02167971|Other|Sham|The patients assigned to this group will undergo 10 sessions of rTMS but with an inactive coil, which will not generate electromagnetic pulses.
16099457|NCT02167958|Drug|Fludarabine|"Fludarabine 30 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days -6 through -2. Fludarabine will be dosed according to the recipient's Adjusted Ideal Body Weight (AIBW) unless AIBW is less than Ideal Body Weight (IBW).
~For decreased creatinine clearance (< 61 mL/min) determined by the Cockcroft Formula:
~Cockcroft-Gault CrCl = (140-age) * (Wt in kg) * (0.85 if female) / (72 * Cr)
~Fludarabine dosage should be reduced per standard of care."
16099458|NCT02167958|Drug|Cyclophosphamide|"Pre-transplant
~Cy 14.5 mg/kg/day will be administered as a 1-2 hour intravenous infusion with a high volume fluid flush on Days -6 and -5. Cy will be dosed according to the recipient's actual body weight unless the patient weighs more than 125% of IBW, in which case the drug will be dosed according to the adjusted IBW
~Post-transplant
~Hydration prior to cyclophosphamide may be given according to Standard Practice Guidelines.
~Cyclophosphamide [50mg/kg] will be given on Day 3 post-transplant (between 60 and 72 hours after marrow infusion) and on Day 4 post-transplant (approximately 24 hours after Day 3 cyclophosphamide). Cy will be dosed according to the recipient's actual body weight unless the patient weighs more than 125% of IBW, in which case the drug will be dosed according to the adjusted IBW. Cyclophosphamide will be given as an IV infusion over 1-2 hours.
~."
16099459|NCT02167958|Drug|Mesna|"Pre-transplant
~Mesna should be given in divided doses IV 30 min pre- and at 3, 6, and 8 hours post-cyclophosphamide. Mesna dose will be based on the cyclophosphamide dose being given. The total daily dose of mesna is equal to 100% of the total daily dose of cyclophosphamide.
~Post-transplant
~Mesna should be given in divided doses IV 30 min pre- and at 3, 6, and 8 hours post-cyclophosphamide. Mesna dose will be based on the cyclophosphamide dose being given. The total daily dose of mesna is equal to 100% of the total daily dose of cyclophosphamide."
16099460|NCT02167958|Radiation|Total Body Irradiation|200 cGy will be administered in a single fraction on Day -1 via linear accelerator.
16099461|NCT02167958|Other|Hematopoietic stem cell infusion|Donors who consent to PBSC donation will receive 5 daily doses of G-CSF, 10 μg/kg/day by subcutaneous injection commencing on day -5. PBSC's will be collected in the afternoon of day -1, stored at 4C overnight, and infused as soon as possible on day 0. If the collection on day -1 contains less than 5.0 X 106 CD34+ cells per kg recipient weight, a second collection will be performed the following morning and infused on day 0. Quantitation of CD34 and CD3 cells will be performed by the Cellular Therapy Lab. For all patients, the target number of CD34 cells to be infused should be 5-6 X 106 cells per kg recipient weight. PBSC in excess of 6.0 x 106 CD34 cells/kg recipient weight may be cryopreserved.
16099462|NCT02167958|Drug|Tacrolimus|Tacrolimus will be given at a dose of .03 mg/kg IV over 24 hours. Tacrolimus will be changed to a PO dosing schedule once a therapeutic level is achieved and the patient is tolerating PO. Whole bloodblood levels of tacrolimus will be measured around Day 7 and then should be checked at least weekly thereafter and the dose adjusted accordingly to maintain a level of 5-10 ng/mL. Tacrolimus will be discontinued after the last dose around Day 180, or may be continued if active GVHD is present. Cyclosporine (target concentration 200-400 ng/ml) may be substituted for tacrolimus if the patient is intolerant of tacrolimus.
16099463|NCT02167958|Drug|Mycophenolate|Either the sodium salt of mycophenolate or mycophenolate mofetil (MMF) may be used as prophylaxis of GvHD and will be dosed by actual bodyweight. Only MMF is available as IV formulation. Sodium mycophenolate will be given at a dose of 10mg/kg PO TID rounded to the nearest number of 180mg tablets. MMF will be given at a dose of 15 mg/kg PO TID. The maximum total daily dose should not exceed 2160 mg (sodium salt) or 3 grams (mofetil). Mycophenolate prophylaxis will be discontinued after the last dose on Day 35, or may be continued if active GVHD is present.
16099612|NCT02166736|Device|FFR|Intervention guided by Fractional Flow Reserve
16099642|NCT02166463|Drug|Brentuximab Vedotin|Given IV
16099464|NCT02167958|Drug|G-CSF|G-CSF will be given beginning on Day 5 at a dose of 5 mcg/kg/day (rounding to the nearest vial dose is allowed), until the absolute neutrophil count (ANC) is > 1,000/mm3 for three consecutive days.
16099465|NCT02167945|Drug|ABT-450/r/ABT-267|tablet
16099466|NCT02167945|Drug|ABT-333|tablet
16099467|NCT02167945|Drug|Ribavirin (RBV)|tablet
16099468|NCT02167932|Behavioral|Walk With Ease|Walk With Ease is the Arthritis Foundation's evidence-based walking intervention to help with fatigue and pain. The intervention is a self-directed program that helps guide participants in a safe and comfortable paced walking program with an ultimate goal of walking for 30 minutes a day, five days a week.
16099469|NCT02167919|Device|Microspheres|Prostatic artery embolization (PAE) is a new procedure that decreases the size of the prostate by blocking its arterial blood flow. Through a tiny puncture in the upper thigh or forearm a catheter is directed to the prostatic artery using fluoroscopic guidance. Once in place, sub-millimeter particles are injected that obstruct the prostatic arteries resulting in gland ischemia, and ultimately, reduction in size. The technique has only been recently developed in Portugal and Brazil and has similarities to Uterine Artery Embolization used to treat uterine fibroids.
16099470|NCT02167906|Other|arterial stiffness measurement|
16099471|NCT02167893|Drug|Leuprorelin acetate|Leuprorelin acetate SR 11.25 mg injection kit
16099472|NCT02167867|Device|Lay End Users|Lay End Users administer 40 minutes of treatment with the ZERONA Z6 to the waist, hips and thighs (20 minutes to the front side and 20 minutes to the back side) of a Treatment Subject, 6 times evenly spaced across two consecutive weeks.
16099473|NCT02167867|Device|Treatment Subject Group|Treatment subject received 6 40-minute evenly spaced treatments to the hips, waist and thighs (20 minutes to the front side and 20 minutes to the back side) with the ZERONA Z6 over 2 consecutive weeks. The ZERONA Z6 contains 6 17.25 milliWatts (mW) 635 nanometers (nm) light-emitting diodes.
16099474|NCT02167854|Drug|BYL719|
16099475|NCT02167854|Drug|LJM716|
16099476|NCT02167854|Drug|TRASTUZUMAB|
16099477|NCT02167841|Behavioral|Knee-Chest Position|
16099478|NCT02167828|Behavioral|Social Support|
16099479|NCT02167815|Device|Mepilex XT|Experimental arm
16099480|NCT02167815|Other|standard care|
16099481|NCT02167789|Device|Paradym CRT 8770|
16099482|NCT02167776|Behavioral|Church-based teaching|In villages that are randomized to receive the intervention, Christian church leaders of both genders and all denominations will be invited to attend an educational seminar about male circumcision. This seminar will last for one day in each intervention village, and will use a curriculum that the investigators' team developed in 2012 based on prior focus group work. Seminars will be conducted in Kiswahili (the national language) and co-taught by a Tanzanian pastor and a Tanzanian clinician who works with the male circumcision outreach campaign. Church leaders will be taught medical, historical, religious, tribal, and social aspects of male circumcision and given tools to lead their congregations in the understanding and practice of male circumcision.
16099483|NCT02167763|Device|VeraCept Intrauterine Copper Contraceptive|
16099484|NCT02167763|Device|TCu380 IUD|
16099485|NCT02167750|Other|Cherry Flavored Beverage|Intervention involves consuming one beverage at the beginning of each visit of the crossover sequence.
16099486|NCT02167737|Behavioral|Bedside Decision Aid|"This group will have an initial FES and VES screening completed in the ED, the TUG test and Chair 30-Second Stand test, and the participant's risk of falling evaluated using our Bedside Decision worksheets. A study team member explains what subjects can do to decrease their risk of falling and discuss what mobility goals are the most important to them.
~Participants will receive a follow-up telephone call approximately six weeks after their discharge from the ED to collect self-reported data about goal completion, and then at four additional times--three, six, nine and 12 months--over the course of a year to collect self-reported data such as fall history."
16099487|NCT02167737|Behavioral|Control Arm|"This group will also have an initial FES and VES screening completed in the ED and the same two mobility tests (TUG and Chair 30-Second Stand). Study staff will advise subjects on how to take action to prevent falls and give them a brochure, What YOU Can Do to Prevent Falls, from the CDC's STEADI Tool Kit for Health Care Providers.
~Participants will receive a telephone call approximately six weeks after their discharge from the ED to collect self-reported data about goal completion, and then at four additional times--three, six, nine and 12 months--over the course of a year to collect self-reported data such as fall history."
16099488|NCT02167724|Other|Bucco-dental examination|
16099489|NCT02167724|Other|Blood sample|
16099490|NCT02167724|Other|Clinical and social questionnaire|
16099491|NCT02167711|Drug|SIRT Yttrium-90|
16099492|NCT02167698|Device|Airway Pressure Release Ventilation (APRV)|This is a newer mode of ventilation that has been hypothesized to be equivalent or even superior to the conventional low-tidal volume mode of ventilation
16099493|NCT02167698|Other|Low-tidal volume ventilation|This mode of ventilation is the standard of care worldwide for ventilating children with ARDS.
16099494|NCT02167698|Drug|Methylprednisolone|Children with primary ARDS presenting within the first 14 days would receive IV low dose Methylprednisolone infusion.
16099495|NCT02167698|Other|Restrictive fluid therapy|Fluid & hemodynamics would be titrated as per pre-designed decision-making protocols
16099496|NCT02167698|Drug|sedo-analgesia titration|
16099497|NCT02167698|Other|Protocolized early enteral nutrition|Early enteral nutrition and attempt to meet calorie-protein goals
16099498|NCT02167698|Other|Protocolized supportive care|Eye care, chlorhexidine mouth wash Q6 hourly, Strict aseptic precautions prior to any procedures, Skin care & bed sore prevention, Adequate pulmonary toileting and chest physiotherapy, frequent position changes, limb physiotherapy, family-centered care
16099499|NCT02167698|Other|Biomarker Assay|Biomarker Assay for patients in both arms
16099500|NCT02167685|Drug|CMX001|
16099501|NCT02167659|Device|23-32 mmHg compression sleeve with gauntlet|A compression intervention consisting of a sleeve and gauntlet with 23-32mm of tension worn for four weeks that is initiated based on a BIS L-Dex change that is ≥6.5 units higher than pre-surgical baseline measure, or a tape measurement guided volume change in the affected arm that is between ≥5% and <10% above pre-surgical baseline.
16099502|NCT02167646|Procedure|Flap including bilateral nerve branches|Two nerve branches are attached with the flap for sensory coverage
16099643|NCT02166463|Drug|Cyclophosphamide|Given IV
16099503|NCT02167633|Procedure|Decompression surgery|Patients will undergo posterior decompression/laminectomy on relevant spinal levels depending on neurological symptoms. If there is a need of spinal stabilization after decompression, patients will undergo posterior instrumentation with pedicle screws and titanium rods. Instrumentation will be done two or three levels above and below each level with metastatic affection.
16099504|NCT02167633|Radiation|Radiosurgery|Patients treated with radiosurgery/SBRT will receive a prescribed dose of 16 Gy in 1 fraction to cover as large a fraction as possible the defined target volume
16099505|NCT02167633|Radiation|Fractionated Radiotherapy|"Patients allocated to surgery will receive postoperative radiotherapy commencing between 10 to 21 days after decompressive surgery. Target should include the entire vertebral body and the vertebral arch at the operated level of the vertebral column.
~Patients receiving postoperative radiotherapy will receive 30 Gy in 10 fractions with 3 Gy pr. fraction. The prescribed dose should cover at least 90 % of the defined target volume."
16099506|NCT02167633|Drug|Glucocorticoids|All patients referred with clinical suspicion of metastatic spinal cord compression will receive high dose glucocorticoids. Dose adjusted to risc of side effects.
16099507|NCT02167633|Drug|Pantoprazole|All patients receiving high dose glucocorticoids will also be prescribed with pantoprazole 40/daily to prevent gastric ulcers
16099508|NCT02167620|Drug|Metformin|Metformin will be dispensed on a biweekly basis, and pill counts conducted at each visit.
16099509|NCT02167620|Drug|Placebo|Placebo will be dispensed on a biweekly basis, and pill counts conducted at each visit.
16099510|NCT02167607|Dietary Supplement|Active Comparator|Purple Potato
16099511|NCT02167607|Dietary Supplement|Placebo Comparator|Placebo Comparator
16099512|NCT02167594|Drug|Flortaucipir F18|IV injection, 370 megabecquerel (MBq) (10 mCi)
16099513|NCT02167594|Procedure|Brain PET scan|positron emission tomography (PET) scan of the brain 75-105 minutes post-injection
16099514|NCT02167568|Genetic|Genetic|
16099515|NCT02167555|Dietary Supplement|Active Comparator|Wild Blueberry Beverage
16099516|NCT02167555|Dietary Supplement|Placebo Comparator|Placebo Beverage
16099517|NCT02167542|Device|Noninvasive Positive Pressure Ventilation|Patients assigned to NPPV were connected to the ventilator through a face mask (VBM Endoscopy Mask) that was secured to the patient's face by the investigator. Only one type of mechanical ventilator will be used (Vision, Philips Respironics). Ventilator parameters and supplemental oxygen will be titrated by the investigator to achieve SpO2>92%. Ventilatory support via face mask will be maintained with the same pressures for at least 30min after FOB, and then will be replaced by the FIO2 mask's if needed.
16099518|NCT02167542|Device|CPAP valve (Boussignac)|"Patients assigned to CPAP Boussignac valve are connected to this device through a face mask that is secured to the patient's face with elastic straps. This kind of CPAP allows the delivery of pressure by constant-flow oxygen insufflation. Four funnel-shaped microchannels are included in the wall of this device and connected to an external opening connected to the oxygen source. These microchannels generate high-velocity microjets, which in turn generate the pressure resulting from the air entrainment mechanism thus created.
~Oxygen flow will be titrated by the investigator to ensure SpO2>92%."
16099519|NCT02167516|Drug|glucosamine sulfate|glucosamine sulfate capsule: One each time, 3 times a day, Oral,for 4 weeks placebo(for Xinfeng capsule): Three each time, 3 times a day, Oral,for 4 weeks
16099520|NCT02167516|Drug|Xinfeng capsule|Xinfeng capsule:Three each time, 3 times a day, Oral,for 4 weeks placebo(for glucosamine sulfate capsule): One each time, 3 times a day, Oral,for 4 weeks
16099521|NCT02167490|Procedure|Arm 1: sentinel node biopsy|Sentinel node biopsy policy
16099522|NCT02167477|Device|Macintosh laryngoscopy|Tracheal intubation
16099523|NCT02167477|Device|Storz C-MAC, standard blade|Tracheal intubation
16099524|NCT02167477|Device|Storz C-MAC, D-BLADE|Tracheal intubation
16099525|NCT02167464|Drug|Renin treatment-guided Therapeutics|Patients are treated based upon their renin levels according to an approved algorithm.
16099526|NCT02167464|Other|Referral Hypertension specialist|Patients are referred to a hypertension specialist.
16099527|NCT02167464|Drug|Aldosterone Antagonist|Spironolactone 12.5 - 25mg daily
16099528|NCT02167451|Drug|Maraviroc|
16099529|NCT02167438|Device|Hem-Avert Perianal Stabilizer|
16099530|NCT02167425|Other|IMAT|The IMAT intervention will combine three main strategies: point-of-care (POC) CD4 screening, provider training and mentoring, and an alerts and reminder dashboard. The POC CD4 platform will provide real-time clinical staging, enabling providers within the methadone clinic to screen HIV-infected patients for ART eligibility. Coupled with this technology, appropriate training and mentoring will predispose providers to effectively link patients to ART and integration of an alert and reminder dashboard will reinforce behavior change and strengthen processes.
16099531|NCT02167386|Behavioral|Enhanced PrEP Adherence|
16099532|NCT02167386|Behavioral|Standard PrEP Adherence|
16099533|NCT02167373|Other|Cogito Companion Intervention|
16099534|NCT02167373|Device|mobile phone application|
16099535|NCT02167360|Drug|CTL019|A dose of CTL019 transduced cells will consist of a single infusion of 2 to 10 x 108 CTL019 transduced cells.
16099536|NCT02167347|Behavioral|Family intervention|This 10 session Multi-modal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component
16099537|NCT02167334|Device|positive pressure ventilation|Positive Pressure Ventilation with a 4 cmH2O inhale pressure, a positive end-expiratory pressure of 4 cm H2O, a trigger 2, an inspiratory slope of 0, an inhaled oxygen fraction of 100% administered at a 10 L / min flow.
16099538|NCT02167334|Procedure|Oxygenation with simple breathing mask|Spontaneously breathing preoxygenation with adapted face mask, to restrict leakage, at 10L/min oxygen, with inhaled fraction of 100% and a 2 L balloon volume.
16099539|NCT02167321|Drug|Arm A : standard neoadjuvant chemoradiotherapy group|radiation : 45Gy±5.4Gy/28Fx/5.5weeks concurrent chemoradiotherapy : 5-FU (400 mg/m2, IV bolus on D1-3, D29-31), leucovorin (20 mg/m2, IV bolus on D1-3, D29-31), preoperative capecitabine : 825 mg/m² p.o. twice daily during XRT, postoperative FL : 5-FU (400 mg/m2, IV bolus)+leucovorin (20m g/m2, IV bolus) on days 1-5 of each 28 day postoperative capecitabine : 1250 mg/m² p.o. twice daily on days 1-14 of each 21 day cycle FOLFOX : oxaliplatin 85 mg/m2, IV over 2 hours on day 1 of each 14 day cycle, leucovorin 200 mg/m2, IV over 2 hours on day 1 of each 14 day cycle, 5-FU 400 mg/m2, IV bolus on day 1 followed by 1200mg/m2 IV over 24 hours on days 1 and 2 of each 14 day cycle
16099540|NCT02167321|Drug|Arm B : adjuvant FOLFOX group|FOLFOX : oxaliplatin (85 mg/m2, IV over 2 hours on day 1 of each 14 day cycle), leucovorin (200 mg/m2, IV over 2 hours on day 1 of each 14 day cycle), 5-FU (400 mg/m2, IV bolus on day 1 followed by 1200mg/m2 IV over 24 hours on days 1 and 2 of each 14 day cycle) postoperative irradiation(if needed) : 54Gy/30Fx/6weeks
16099541|NCT02167308|Device|Laser acupuncture|a GaAlAs semiconductor diode Laser Phototherapy Device with a wavelength of 808nm. Maximum power output is 150 milliwatt in continuous wave mode.
16099542|NCT02167269|Device|Baby EAR|A modification of the Enclosed Afferent Reservoir anesthesia circuit (EAR) for pediatric use by adding a KKU one-way valve in the expiratory limb
16099543|NCT02167256|Drug|AZD0530 100mg daily|All patients in experimental group (50%) will be started on 100mg AZD0530 daily
16099544|NCT02167256|Drug|AZD0530 125mg daily|Patients with plasma drug level <100ng/ml after 2 weeks of 100mg AZD0530 daily will receive 125mg daily of AZD0530.
16099545|NCT02167256|Drug|Placebo|50% of patients will receive placebo treatment for the duration of the study.
16099546|NCT02167243|Behavioral|Reinforcement for BG testing|Subjects will receive reinforcement for BG tests. The intervention will reinforce subjects for conducting Self Monitoring of Blood Glucose (SMBG), with escalating reinforcers provided when subjects achieved sustained periods of testing at least 4 times/day at appropriate intervals.
16099547|NCT02167243|Other|Standard of care|Subjects receive standard of care
16099548|NCT02167230|Procedure|Jailed-balloon technique|A monorail balloon is placed in the side branch(SB) before the stent in main branch(MB) is deployed. After MB stent is deployed to nominal pressure, the balloon in SB is inflated to 3 atm generally but to higher pressure to perform angioplasty if the blood flow in SB is compromised. The balloon in SB is then removed while the wire in SB is left in place. The MB stent balloon is inflated again for stent apposition. The SB wire is left in place to facilitate rewiring if the blood flow in SB is compromised. Otherwise the SB wire is removed after the stent balloon is inflated again.
16099549|NCT02167230|Procedure|Jailed-wire technique|A percutaneous transluminal coronary angioplasty(PTCA) wire is placed in the side branch(SB) before the stent in main branch(MB) is deployed. After MB stent is deployed to some pressure to achieve full apposition, the wire in SB is left in place to facilitate rewiring if the blood flow in SB is compromised. Otherwise the SB wire is removed after the MB stent is deployed.
16099550|NCT02167217|Drug|Prednisolone|Prednisolone (5mg per kg) will be taken on two consecutive days, Friday and Saturday mornings each week with breakfast
16099551|NCT02167204|Procedure|Computed Tomography|Undergo 18F-FLT PET/CT
16099552|NCT02167204|Radiation|Fluorothymidine F-18|Undergo 18F-FLT PET/CT
16099553|NCT02167204|Procedure|Positron Emission Tomography|Undergo 18F-FLT PET/CT
16099554|NCT02167191|Behavioral|HIT|12 sessions of HIT exercise in 31 days on a stationary cycle ergometer
16099555|NCT02167178|Other|Administration of 0.9% NaCl solution|Volunteers administered 0.9% NaCl solution in 250ml boluses
16099556|NCT02167178|Other|Measurement of stroke volume|The measurement of stroke volume will be performed using an Oesophageal Doppler Monitor.
16099557|NCT02167178|Other|Measurement of microvascular blood flow|Microvascular blood flow will be measured using a contrast enhanced ultrasound scan.
16099558|NCT02167178|Other|Administration of gelofusine|Volunteers administered gelofusine in 250ml boluses
16099559|NCT02167165|Drug|Digoxin Injection|Patients consulting the ED for Acute onset AF received 0.5 mg digoxin by oral root
16099560|NCT02167152|Other|Ischemic preconditionin|Ischemic preconditioning will be accomplished through 4 cycles of alternating 5-minute inflation and 5-minute deflation of an upper-arm blood pressure cuff to the patient's systolic blood pressure plus 50% to induce ischemia and reperfusion.
16099561|NCT02167139|Drug|Humira (adalimumab)|
16099562|NCT02167139|Drug|SB5 (proposed biosimilar to adalimumab)|
16099563|NCT02167126|Device|Kinesio Taping|"using the V technique, the knee was positioned at 45º of flexion, the origin of both tapes was located 10 cm below the anterior-superior iliac spine with one tape going laterally and one medially to the rectus femoris muscle belly, passing around the patella and finishing on the tibial tuberosity."
16099564|NCT02167126|Device|Placebo Tape|"Micropore tape was applied using the V technique, the knee was positioned at 45º of flexion, the origin of both tapes was located 10 cm below the anterior-superior iliac spine with one tape going laterally and one medially to the rectus femoris muscle belly, but because it is not elastic, the knee joint was not crossed and the end points were the medial and lateral aspects of the patella."
16099565|NCT02167087|Procedure|Sentinel node mapping|Through transabdominal access via laparoscopic ports indocyanine green solution is injected around the tumor (25 mg indocyanine green dissolved in 9 ml sterile water and 1 ml 20% human albumin). This is done by the construction of two small boluses of 0.5 mL each into the colonic wall just orally and anally to the tumor margin, but not within the tumor itself. When the bolus is injected the fluorescence is controlled and after 20 minutes the surgeon looks for sentinel nodes in a standardized manner.
16099566|NCT02167074|Device|25G FNA needle|
16099567|NCT02167074|Device|20G ProCore FNB needle|
16099568|NCT02167061|Drug|DA-1229_01|complex single administration
16099569|NCT02167061|Drug|E+M|co-administration of 2 drugs
16099570|NCT02167061|Drug|DA-1229_01 fast|
16099571|NCT02167061|Drug|DA-1229_01 fed|
16099572|NCT02167048|Drug|Psychostimulants|"Participants will be tested twice 2 weeks apart. All will continue on their normal Psychostimulant dose up until 3 days before the testing day. 3 days before their 1st testing session, half the participants will start on either their current-dose of Psychostimulant or half their current dose depending on the arm they were randomized to (we provide those pills).
~To control for different pharmacokinetics of the Psychostimulant medications, a given participant will be tested at roughly the peak time for his/her specific version of Psychostimulant and at the same time of day for his/her two testing sessions."
16099573|NCT02167035|Drug|Combigan Two Times Daily (BID)|
16099574|NCT02167035|Drug|Simbrinza Three Times Daily (TID)|
16099635|NCT02166541|Procedure|INRS|"The INRS is a treatment program developed at the International Clinic of Rehabilitation where the spinal manipulation is one of several components. There may be some variation in treatment depending on the clinical situation. All children receive the main treatment components which are massage, physical therapy, warm wax and paraffin applications and low electro stimulation with a special portable device as a part of treatment called Reflexotherapy."
16099575|NCT02167022|Other|Physical and occupational therapy|The type of physiotherapy to be administered is Perception-Action (P-A). The P-A (motor) intervention is a child-driven approach without the need for special equipment and considers the child and environment as a single unit.Treatment is a coupling of the child with the environment. The environment is changed to enable, enhance or stimulate movement. The action is initiated by the child with the therapist augmenting the child's environment using touch (tactile information) or light support (cushions, bolsters, and gentle touch or pressure) to assist and/or alter the child's active movement. Toys are used and positioned in different places to encourage movement of upper and lower extremities and the trunk; reaching, turning, sitting balance, crawling, walking.
16099576|NCT02167009|Device|Embosphere Microspheres|Embosphere Microspheres are indicated for use in embolization of arteriovenous malformations, hypervascular tumors, and symptomatic uterine fibroids.
16099577|NCT02166996|Procedure|Suture removal time 7 days|To compare cosmetic outcome of surgical defects of head and neck, repaired with non-resorbable monofilament nylon sutures from the aspect of suture removal time 7 days.
16099578|NCT02166996|Procedure|Suture removal time14 days|To compare cosmetic outcome of surgical defects of head and neck, repaired with non-resorbable monofilament nylon sutures from the aspect of suture removal time 14 days
16099579|NCT02166983|Other|computer-assisted cognitive training|Complete Lumosity cognitive exercises
16099580|NCT02166983|Other|cognitive intervention|Complete Active Journaling cognitive exercises
16099581|NCT02166983|Procedure|mind-body intervention procedure|Complete relaxation exercises
16099582|NCT02166983|Other|memory intervention|Complete compensatory strategies
16099583|NCT02166983|Other|questionnaire administration|Ancillary studies
16099584|NCT02166970|Device|Metallic stent deployment in hilar obstruction|Single stent insertion: metal stent deployment to right or left intrahepatic duct Multiple stenting: Stent-in-stent or side-by-side deployment
16099585|NCT02166957|Procedure|Recanalization|"All patients received clear and detailed information about the different steps, the benefits and the risks of the procedure they would undergo, and gave an informed consent.
~The rendez-vous technique shared some common characteristics whatever the etiology and the length of esophageal disruption. First, prior to start the specific endoscopic management, all the patients needed to have undergone a surgical gastrostomy one month earlier in order to allow the retrograde access. This one-month delay was necessary to get it completely healed before using it for the procedure.
~The principle of the combined anterograde retrograde approach is to get an endoscopic access to both the proximal and distal side of the obstruction in the purpose to achieve better and safer recanalization, which could be carried out with either transillumination or using a needle under x-rays guidance."
16099586|NCT02166944|Drug|tamoxifen 40 mg daily for one year|both arms with riluzole daily
16099587|NCT02166931|Dietary Supplement|Chicken Essence|BRAND'S® Chicken Essence of 70cc daily for 2 weeks Placebo 70 cc daily for 2 weeks
16099588|NCT02166905|Biological|DEC-205/NY-ESO-1 Fusion Protein CDX-1401|Given via intracutaneous injection
16099589|NCT02166905|Drug|Epacadostat|Given PO
16099590|NCT02166905|Other|Laboratory Biomarker Analysis|Correlative studies
16099591|NCT02166905|Other|Pharmacological Study|Correlative studies
16099592|NCT02166905|Drug|Poly ICLC|Given SC
16099593|NCT02166892|Other|Specially designed plates|
16099594|NCT02166879|Behavioral|Questionnaire|Participants complete anesthesia questionnaire before elective surgical procedure.
16099595|NCT02166866|Other|Quality of Life Questionairre and Education|
16099596|NCT02166853|Drug|sevoflurane|Sedation with inhaled sevoflurane
16099597|NCT02166853|Drug|midazolam|Sedation with intravenous midazolam
16099598|NCT02166840|Procedure|Plastic stent (7-10Fr)|
16099599|NCT02166840|Procedure|Self Expanding Metal Stent|
16099600|NCT02166827|Device|NeuroAD|Synchronized TMS and cognitive stimulation to 6 brain areas.
16099601|NCT02166827|Device|Sham TMS+Cog|Sham Device, has the same appearance and sound as the real device, combined with sham cognitive exercises.
16099602|NCT02166814|Drug|Fimasartan and Rosuvastatin|
16099603|NCT02166814|Drug|Fimasartan|
16099604|NCT02166814|Drug|Rosuvastatin|
16099605|NCT02166801|Behavioral|Early intervention for infants|Three foci are included in the intervention: Communication, Hand function and Mobility/gross motor function. The Hand & Cognition and Mobility steps will be conducted during two time-periods. Communication will have a separate one-time intervention at the start of the study (prior to step I) in addition to one intervention period during step III (figure 1). General principles for the small step program: Training will be conducted in the children's home by the parents on a daily basis. The families will get instructions and supervision in their home every week by the therapist responsible for each specific step of the intervention. For each focus there will be different steps using an adaptive logarithm for training, i.e., adapted to the functional level of the child aiming at the next small developmental step. The family will be actively involved in identifying new foci for practice.
16099606|NCT02166801|Behavioral|usual care|Children displaying delayed development and at risk of developing cerebral palsy are continuously followed-up at the children's hospital. There are no strict rules for the frequency of appointments within the usual care program but the families typically meet a physiotherapist every third week during the first 2-3 months, thereafter about once a month. The frequency depends on the family's needs and wishes. If there is a continuous need for therapeutic intervention and need of contact with different professions, the families will be referred to the Habilitation Services when the child is between 8-12 months. The control group will follow this customary procedure in the hospital. The only difference will be the assessment procedure, the sessions with the speech pathologist and that they will get feedback of the children's progress after each examination.
16099607|NCT02166788|Procedure|Inguinal Lymphadenectomy|
16099608|NCT02166788|Procedure|Ilio-inguinal Lymphadenectomy|
16099609|NCT02166762|Procedure|QLV interval measurement|Measurements of the QLV interval is defined from the onset of the QRS width of the surface ECG to the first large positive or negative peak of the LV EGM during a cardiac cycle. Recorded EGM's will be measured at three distinct points (basal, mid, and distal) within each target vessel.
16099610|NCT02166749|Procedure|Subtotal abdominal hysterectomy|Comparison of women undergoing subtotal abdominal hysterectomy (n=107) and women with total abdominal hysterectomy (n=105) a mean of 33 years ago.
16099613|NCT02166723|Device|Cryoballoon Ablation|. The goal was to isolate all 4 veins with application of cryoballoon on the ostium of the vein. A 28 mm balloon was used with centrifugal cooling system. The maximum temperature reached was between -45 C and -60 C to optimize irreversible isolation without causing extracardiac complications. A circular catheter (Achieve) was used to map electrograms in conjunction with the NavX ENSITE 3000, St Judes . Intracardiac ultrasound was used to measure the pulmonary vein diameter, check for intraoperative complications, determine complete occlusion of the vein by the balloon and guide transeptal puncture. . In each patient the left atrium was debulked by applying cryoballoon
16099614|NCT02166723|Device|cryoballoon ablation|A 28 mm balloon was used with centrifugal cooling system. The maximum temperature reached was between -45 C and -60 C to optimize irreversible isolation without causing extracardiac complications. A circular catheter (Achieve) was used to map electrograms in conjunction with the NavX ENSITE 3000, St Judes . Intracardiac ultrasound was used to measure the pulmonary vein diameter, check for intraoperative complications, determine complete occlusion of the vein by the balloon and guide transeptal puncture. In each patient the left atrium was debulked by applying cryoballoon to the left and right sides of the left atrial roof and cryoablation of the left lateral ridge from within the left atrial appendage.
16099615|NCT02166710|Device|Adductor canal femoral nerve block|A 18 Gauge Tuohy needle will be inserted and its position will be confirmed using ultrasound guidance. Once the adequacy of the position is confirmed, the anesthesiologist will administer 15 mL of bupivacaine 0.25% with epinephrine in divided doses and examine the quality of its spread. A 20 Gauge polyamide catheter will be inserted at 2 cm in the space. The needle will then be withdrawn and the catheter will be fixed in place. Three mL of the same mixture of local anesthetics will be administered through the catheter and the anesthesiologist will observe the quality of its distribution. Bupivacaine 0.125% will be administered through the catheter using an infusion pump for 48 hours. Knee extensor muscle strength, pain and side-effects will be assessed at different time-points.
16099616|NCT02166710|Device|Simulated nerve blockade|The insertion of the Tuohy needle and the injection of 15 mL of bupivacaine 0.25% with epinephrine will be simulated. The insertion of the polyamide catheter, the withdrawal of the needle and the injection of local anesthetics through the catheter will also be simulated. The infusion of bupivacaine 0.125% will also be simulated for 48 hours. Knee extensor muscle strength, pain and side-effects will be assessed at different time-points.
16099617|NCT02166697|Drug|candesartan cilexetil|candesartan cilexetil tablets
16099618|NCT02166684|Device|Do-it-yourself devices|"Medisana Vifit is worn every day all-day by each subject
~Subjects use Medisana MTX Blood pressure monitor twice per week for 13 weeks to measure their blood pressure.
~Blood cholesterol is measured by subjects using the Mission Cholesterol 3-1 meter once at baseline and once after 13 weeks
~Subjects use Medisana BS 440 BT scale daily
~In three weeks (week 1, week 7 and week 13) subjects self-record food intake at three days (two week days and on weekend day) using the FatSecret app.
~Subjects self-measure fasting blood glucose twice per week for 13 weeks.
~Subjects perform a do-it-yourself Oral Glucose Tolerance Test in week 1 and week 13. Subjects use the Medisana MediTouch 2 for assessing blood glucose levels at t=0, t=30, t=60, t=90 and t=120."
16099619|NCT02166671|Biological|HBV booster vaccination 1dose|
16099620|NCT02166658|Drug|Cabazitaxel|Cabazitaxel 25 mg/m2 i.v. infusion (infusion time about 1h) on D1 of each 21-day cycle. Continuation of treatment until progression of brain metastases or unacceptable toxicity.
16099621|NCT02166645|Other|Prone position|Participants of intervention group will be placed in prone position immediately after extubation and positioned over a roll to raise the chest and facilitate diaphragmatic dynamic, with lateralized head and aligned with the trunk, upper and lower limbs flexed and hands near the face, facilitating hand-mouth access.
16099622|NCT02166645|Other|Supine position|Participants of control group remain in supine position after extubation and positioned with the head in the midline, with the upper side of the thorax and brought forward and rolls down the legs to promote slight flexion (30-40º) in the hips and knees.
16099623|NCT02166632|Procedure|Intracapsular Injection|"The amount of bupivacaine liposome (ExparelTM) will be injected directly into the joint capsule (intracapsular injection), effectively bathing the joint in the medication."
16099624|NCT02166632|Procedure|Periarticular Injection|The amount of bupivacaine liposome (ExparelTM) will be injected periarticulary, via 9 standard periarticular tissue sites around the joint
16099625|NCT02166619|Device|tDCS + physical therapy|"Bihemispheric tDCS involves application of very low-amplitude direct currents (2 mA or less) via surface scalp electrodes. It produces a sub-sensory level of electrical stimulation wich remains imperceptible by most people during application. In a small percentage of patients, it may cause minimal discomfort with a mild tingling sensation, which usually disappears after a few seconds. Depending on the polarity, tDCS can increase or decrease corticomotor excitability. Anodal tDCS is able to facilitate neurons depolarization - increasing cortical excitability - while, on the other hand, cathodal tDCS hyperpolarizes the resting membrane potential, reducing the neuronal firing and the cortical excitability.
~Other: Physical Therapy"
16099626|NCT02166606|Device|ImageReady MR Conditional Pacing System Implant|Implant according to standard-of-care. No study-specific interventions in that registry.
16099627|NCT02166593|Drug|Pravastatin40mg/Fenofibrate160mg|Pravafenix(Pravastatin40mg/Fenofibrate160mg)
16099628|NCT02166593|Drug|Atorvastatin Sodium 10mg|Lipitor 10mg(Atorvastatin Sodium)
16099629|NCT02166567|Procedure|Staining of spermatozoa with the YoPro dye and sorting of the stained spermatozoa with FACS|
16099630|NCT02166567|Procedure|Swim-up|Semen processing will be carried out with the conventional swim-up method.
16099631|NCT02166554|Other|Saline|On the day of initial surgery
16099632|NCT02166554|Device|Cross-linked Hyaluronan Hydrogel|On the day of the initial surgery
16099633|NCT02166541|Procedure|BCSK|"The BCSK is a specific technique of polysegmental spinal manipulation developed by Professor Kozyavkin based on applying quick short impulse aimed on moving intervertebral joints outside restrictive barrier."
16099634|NCT02166541|Procedure|Traditional spinal manipulation|Spinal manipulation by traditional technique is a mild mobilization without impulse, based on applying gentle repetitive force without crossing restrictive barrier.
16099636|NCT02166489|Biological|Intravenous injection autologous mesenchymal stem cells|Intravenous injection of mesenchymal stem cell in patients with PKD
16099637|NCT02166476|Drug|Meropenem-Vaborbactam|Meropenem-vaborbactam
16099638|NCT02166476|Drug|Piperacillin-Tazobactam|Piperacillin-tazobactam
16099644|NCT02166463|Drug|Doxorubicin Hydrochloride|Given IV
16099645|NCT02166463|Drug|Etoposide|Given IV
16099646|NCT02166463|Other|Laboratory Biomarker Analysis|Correlative studies
16099647|NCT02166463|Drug|Methylprednisolone|Given IV
16099648|NCT02166463|Other|Pharmacological Study|Correlative studies
16099649|NCT02166463|Drug|Prednisone|Given PO
16099650|NCT02166463|Other|Quality-of-Life Assessment|Ancillary studies
16099651|NCT02166463|Other|Questionnaire Administration|Ancillary studies
16099652|NCT02166463|Drug|Vincristine Sulfate|Given IV
16099653|NCT02166450|Drug|Nystatin|100 000 IU every 6 h as a suspension
16099654|NCT02166424|Dietary Supplement|Omega-3 polyunsaturated fatty acids|
16099655|NCT02166424|Dietary Supplement|Olive oil|
16099656|NCT02166411|Procedure|myomectomy using barbed sutures|A transverse incision will be made over the myoma using unipolar hook and a cleavage plane between the myoma and uterus will be developed by sharp dissection. After the identification of the cleavage plane, the fibroid will be enucleated by means of adequate traction with a strong grasper and countertraction maneuvers with another grasping forceps . Bipolar forceps will be used to coagulate bleeding points . The myometrial edges will be reapproximated in one or two layers (according to the depth of the uterine wound) by using a 24-cm × 24-cm 0 polydioxanone double-armed suture on a 26-mm half-circle reverse cutting needle( STRATAFIX™ Spiral PDO Knotless Tissue Control Device, Ethicon Inc , Somerville, NJ, USA ).
16099657|NCT02166411|Procedure|myomectomy using conventional sutures|A transverse incision will be made over the myoma using unipolar hook and a cleavage plane between the myoma and uterus will be developed by sharp dissection. After the identification of the cleavage plane, the fibroid will be enucleated by means of adequate traction with a strong grasper and countertraction maneuvers with another grasping forceps . Bipolar forceps will be used to coagulate bleeding points . Myometrial edges will be re-approximated using 1-0 polyglactin 910 suture(VICRYL™.; Ethicon Inc, Sommerville, NJ)
16099658|NCT02166398|Drug|UI15AML055MT|tab, PO
16099659|NCT02166398|Drug|Amosartan 5/50|tab, PO
16099660|NCT02166372|Other|Observation of natural course of Diabetes Mellitus Type 2|
16099661|NCT02166359|Drug|Extraneal (Icodextrin)|
16099662|NCT02166359|Drug|Glucose solution|
16099663|NCT02166346|Drug|Dalfampridine|Dalfampridine 10 mg twice daily for 8 weeks
16099664|NCT02166346|Drug|Placebo|Placebo pill 1 tablet twice daily for 8 weeks
16099665|NCT02166333|Dietary Supplement|200 IU/d cholecalciferol|
16099666|NCT02166333|Dietary Supplement|1000 IU/d cholecalciferol|
16099667|NCT02166333|Dietary Supplement|2000 IU/d cholecalciferol|
16099668|NCT02166333|Dietary Supplement|4000 IU/d cholecalciferol|
16099669|NCT02166320|Device|Partially covered SEMS|
16099670|NCT02166320|Device|Fully covered SEMS|
16099671|NCT02166294|Other|NEOX® CORD 1K|Amniotic Membrane Tissue is fetal membrane tissue that comprises the innermost layer of the human placenta, and the outermost lining of the umbilical cord. In addition to amniotic membrane, the umbilical cord also contains Wharton's jelly, a rich source of proteoglycans and growth factors. These tissues share the same cell origin as the fetus and serve to protect the fetus during development. This product does not contain live cells.
16099672|NCT02166294|Procedure|Standard of Care (Pressure Bandage)|Standard of Care wound, pressure dressing applied as needed at each visit.
16099673|NCT02166268|Drug|AVANZ Phleum pratense 15,000 SQ+|
16099674|NCT02166268|Drug|Placebo|
16099675|NCT02166255|Biological|siRNA-transfected peripheral blood mononuclear cells APN401|Given IV
16099676|NCT02166255|Other|laboratory biomarker analysis|Correlative studies
16099677|NCT02166242|Drug|ethaselen|ethaselen is a specific thioredoxin reductase inhibitor, which has finished phase 1a study in China, phase 1 study of ethaselen showed that 600 mg ethaselen bid could be well tolerated
16099678|NCT02166229|Drug|Divalproex sodium|
16099679|NCT02166190|Procedure|Radiofrequency Ablation using EndoHPB Probe|Radiofrequency Ablation using EndoHPB Probe
16099680|NCT02166190|Procedure|Stenting only|Stenting only
16099681|NCT02166177|Drug|Autologous regulatory T cell product|Autologous regulatory T cell therapy infused intravenously (2 dose groups: low dose and high dose). The patients also receive rabbit Antithymocyte Globulin (rATG), tacrolimus, and sirolimus.
16099682|NCT02166164|Other|Brief thermal sensitization|A small area of the skin of the study participants are heated to 45 degree celsius for 3 minutes, followed by evaluation of secondary hyperalgesia.
16099683|NCT02166164|Other|Long thermal stimulation|A small area of the skin of the study participants are heated to 45 degrees celsius for 1 minute. During the 1 minute period, the study participant will continually report pain on an electronic visual analog scale.
16099684|NCT02166164|Other|Heat-pain-detection threshold|"The threshold for heat pain are evaluated by heating a small area of the study participants skin. When the study participant feels pain, the temperature (degrees celsius) is registered.
~4 threshold measurements per session. Heat pain threshold is defined as the average temperature of the 4 measurements."
16099685|NCT02166151|Drug|Omalizimab|Omalizimab 150 mg S.C. once a month for consecutive 3 months
16099686|NCT02166138|Procedure|Non-Abilative Laser treatment|Patients in this group will be given the laser treatment with the non-abilative 1540 nm wavelength. Patients will be blinded to this procedure as they will be wearing protective eye wear and noise canceling headphones. These patients will undergo the treatment 3 times, one at day of discharge, second at the 4 week follow up visit, and third at the 8 week follow up visit. After the 8 week follow up visit, patients will be asked to come in for the 3 month follow up visit and 1 year follow up visit for an evaluation. At each visit, the patient's scar will be photograph for evaluation. Each patient will also be asked to fill out the POSAS, and KOOS at each follow up visits.
16099687|NCT02166125|Procedure|Endosuturing|Endoscopic suturing
16099688|NCT02166112|Procedure|Permacol mesh placement|All patients were treated for a complex abdominal wall hernia by implantation of Permacol mesh. This intervention took place before patients were included in the cohort.
16099689|NCT02166099|Procedure|Choledochoscopy using Digital Spyglass|Choledochoscopy using Digital Spyglass during Endoscopy
16099690|NCT02166086|Procedure|Endoscopy|Endoscopy involving advanced imaging techniques
16099691|NCT02166060|Drug|Ivabradine|Ivabradine 5 mg twice a day or 7,5 mg twice a day
16099692|NCT02166047|Drug|Vesatolimod|Vesatolimod tablet administered orally
16099693|NCT02166047|Drug|Placebo|Placebo to match vesatolimod tablet administered orally
16099694|NCT02166034|Behavioral|garden intervention|The intervention includes raised bed garden kits for participating classes as well as access to garden-based curriculum.
16099695|NCT02166021|Biological|Mesenchymal stem cells|A culture of purified MSCs was prepared under aseptic conditions, and cultured for 4 weeks, until they reached confluency, and were then harvested. After sterility was confirmed, the cells resuspended in normal saline at a concentration of 10 × 106/mL to 15 × 106/mL.
16099696|NCT02166008|Drug|Repamipide|
16099697|NCT02166008|Drug|Placebo|
16099698|NCT02165995|Procedure|Motor Mapping|Motor mapping performed using nTMS system before surgery, then again at 1, 3, 6, and 12 months following surgery. Pads to monitor movements placed on face, arms and legs. A coil that is used to deliver stimulation will be placed on head. During stimulation, participant be asked to move certain muscles and will be monitored for motor responses over the course of 20 to 30 minutes.
16099699|NCT02165995|Procedure|Speech Mapping|Speech mapping performed using nTMS system before surgery, then again at 1, 3, 6, and 12 months following surgery. Participant shown 95 black-and-white drawings of common objects and asked to name them. During stimulation, participant asked to name the objects again and will be monitored for changes in speech or delays. This should take about 1½-2 hours to complete.
16099700|NCT02165969|Procedure|endoscopic endonasal surgery with UPSIT|
16099701|NCT02165956|Dietary Supplement|New Infant Cereal|New Infant Cereal
16099702|NCT02165956|Dietary Supplement|Standard Infant Cereal|Standard Infant Cereal
16099703|NCT02165943|Device|Vitoss|Vitoss is a synthetic calcium-based bone void filler made of beta-tricalcium phosphate.
16099704|NCT02165930|Drug|Oxycodone|One capsule of 40 mg PF-00345439 Formulation K, single dose, administered with water, under fasting conditions
16099705|NCT02165930|Drug|Naltrexone|Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before,and 12 hours after study drug administration).
16099706|NCT02165930|Drug|Oxycodone|One capsule of 40 mg PF-00345439 Formulation K, single dose, administered with 40% ethanol, under fasting conditions
16099707|NCT02165930|Drug|Naltrexone|Single dose of 40 mg PF-00345439 under naltrexone block (50 mg of naltrexone administered by mouth 12 hours before, 30 minutes before, and 12 hours after study drug administration).
16099708|NCT02165917|Procedure|Excision plus hyaluronic acid gel|Excision of endometriosis foci by laparoscopic standard methods followed by an application of 10 cc Hyaluronic acid gel, in order to prevent postsurgical adhesions.
16099709|NCT02165917|Procedure|Excision only|Excision of endometriosis foci by laparoscopic standard methods only.
16099710|NCT02165904|Biological|Adult Autologous Mesenchymal Bone Marrow Cell|Diagnosed patients with incomplete spinal cord injury and chronically established SCI will be treated with Adult Autologous Mesenchymal Bone Marrow Cells.
16099711|NCT02165891|Drug|insertion of a chest drain with urokinase instillation|Other interventions except drainage procedure are the same in both arms
16099712|NCT02165891|Procedure|primary video-assisted thorascopic surgery|
16099713|NCT02165865|Procedure|upper extremity/ hand transplantation|hand transplant on unilateral dominant hand or bilateral upper extremity amputees
16099714|NCT02165852|Procedure|Papillectomy without injection|Conventional endoscopic mucosal resection of ampulla of Vater using a snare with electrocurrent.
16099715|NCT02165852|Procedure|Papillectomy with injection|Conventional endoscopic mucosal resection of ampulla of Vater without submucosal saline or diluted epinephrine injection.
16099716|NCT02165839|Behavioral|Brief Behavioral Therapy for Insomnia (BBT-I)|
16099717|NCT02165839|Behavioral|Healthy Eating Education Learning (HEAL)|
16099718|NCT02165826|Drug|Roflumilast|Roflumilast tablets
16099719|NCT02165826|Drug|Roflumilast Placebo|Roflumilast placebo-matching tablets
16099720|NCT02165826|Drug|Standard of Care COPD Treatment|The participant is on standard of care COPD maintenance treatment including LABAs, long-acting anticholinergics, or any combination thereof taken on a constant daily dose within 12 weeks prior to Screening (Visit V0) Examples of LABA containing products are: Formoterol, Salmeterol, Indacaterol, Formoterol/Budesonide, Salmeterol/Fluticasone, Treatment including lon-acting anticholinergics: Tiotropium, Aclidinium.
16099721|NCT02165813|Drug|Nitazoxanide|Nitazoxanide is a synthetic drug of the nitrothiazolide class. The main metabolite of NTZ is tizoxanide. The active ingredient is Nitazoxanide (2-acetyloxy-N(5-nitro-2-thiazolyl)benzamide), a synthetic agent for oral administration, at a concentration of 100 mg/5 ml.
16099722|NCT02165813|Drug|placebo|An oral suspension is supplied as a pink coloured powder formulation (sugar) that is reconstituted with 48 mL water prior to use to a final volume of 60 mls.
16099723|NCT02165800|Procedure|L-PANP-TME|
16099724|NCT02165800|Procedure|O-PANP-TME|
16099725|NCT02165774|Device|Turning OFF the neuromodulator|Turning OFF the neuromodulator in 50% of the patients in a randomized way by an investigator not involved in the assessment of the clinical outcome during the regular outpatient visit 2 months after neuromodulator implantation. It then follows a 2 months double-blind phase. Thereafter, i.e. during the regular outpatient visit 4 months after neuromodulator implantation, the unblinding takes place and in patients with sacral neuromodulation OFF, the neuromodulator is switched ON.
16099726|NCT02165774|Device|Turning ON the neuromodulator|
16099727|NCT02165761|Device|GORE® Hybrid Vascular Graft|
16099728|NCT02165761|Device|Non-heparin bonded synthetic graft|
16099729|NCT02165735|Behavioral|patient activation training|Patient activation training involves six, 90-minute, group (8-12 person) training sessions facilitated by trained peers and training staff and one (20-30 minute) pre-visit coaching session conducted by staff. The hands on group training includes: 1) HIV education; 2) use of a handheld smart device; 3) use of an HIV electronic personal health record app that runs on the smart device; 4) identification of patients' visit need priorities and skills for communicating with their HIV provider. The pre-visit coaching includes identification of patient concerns and patient behavioral rehearsal for asking about these concerns.
16099730|NCT02165735|Other|Usual care|Usual HIV care
16099764|NCT02165397|Drug|Placebo|Participants will receive placebo capsules orally.
16099765|NCT02165397|Drug|Rituximab|Participants will receive rituximab 375 mg/m^2 IV.
16099731|NCT02165722|Behavioral|4 Pillars Toolkit|"Behavioral: Pillar 1: Convenient Vaccination Services (e.g. use every visit [chronic and acute] as an opportunity to vaccinate; use express vaccination clinics and dedicated vaccination stations; use influenza vaccination as an opportunity to vaccinate for other vaccines).
~Behavioral: Pillar 2: Patient Notification (e.g. use electronic reminders and social media for vaccination reminders; use physician recommendations).
~Behavioral: Pillar 3: Enhanced Office Systems (e.g. implement Standing Order Programs; use EMR prompts; add vaccination status as a vital sign when rooming).
~Behavioral: Pillar 4: Motivation (e.g. establish an office Immunization Champion to track goal progress, aided by research team feedback)."
16099732|NCT02165709|Procedure|Salpingectomy|
16099733|NCT02165709|Procedure|Traditional sterilization|
16099734|NCT02165696|Other|Multimodal treatment: compression bandaging and manual lymph drainage.|30 minutes and one hour maximum time of manual lymphatic drainage and compression bandaging with multilayer inelastic bandages with low extensibility. It is possible to apply bandages two or three times per week. Also, an elastic bandage is also held in hand fingers with slight compression and other protective bandage is used in skin. The treatment will be carried out for six weeks five days a week
16099735|NCT02165696|Other|Manual lymph drainage|30 minutes and one hour maximum time of manual lymphatic drainage. The treatment will be carried out for six weeks five days a week.
16099736|NCT02165670|Device|Coronary stenting with CE-marked stent|
16099737|NCT02165657|Device|Excimer laser treatment|Excimer laser irradiation twice a week for up to 20 treatments.
16099738|NCT02165644|Drug|Acetazolamide|"Acetazolamide 250 mg QID oral for 4 days along with standard of care which includes Nimodipine 60 mg orally every 4 hours, with therapy starting within 96 hours of the event and continued for 21 days.
~If the drug can't be given orally, then feeding tube (NG Tube or DHT) will be used for drug administration."
16099739|NCT02165644|Drug|Nimodipine|Nimodipine 60 mg orally every 4 hours, with therapy starting within 96 hours of the event and continued for 21 days
16099740|NCT02165618|Other|Medication review, based on but not limited to the RASP list|"Systematic approach:
~Medication reconciliation
~Applying the RASP list
~Expert review (not based on the RASP list)
~Multidisciplinary discussion"
16099741|NCT02165605|Drug|HylaCare|cream
16099742|NCT02165605|Drug|Placebo|placebo
16099743|NCT02165579|Other|1 cohort, standard care, observational|This is one cohort standard care observational study. 40 diabetic patients admitted to Parkland hospital with a foot infection. We will enroll a representative cross section of subjects with diabetic foot infection. Patient will be consented and will receive therapy based on standard protocols. Currently patients with suspected osteomyelitis have bone biopsies to identify bacterial pathogens and verify MRI diagnosis. Repeat bone biopsies are performed at the end of therapy to verify that osteomyelitis has been successfully treated. Serum to measure procalcitonin will be obtained at baseline, week 3 and week 6. Tissue samples will be obtained at Baseline, Week 3 and Week 6 for tissue culture.
16099744|NCT02165566|Drug|Regular-insulin|patients are assigned in a random sequence to receive Regular-insulin or lispro-insulin infusion
16099745|NCT02165566|Drug|Lispro-insulin|patients are assigned in a random sequence to receive Regular-insulin or lispro-insulin infusion
16099746|NCT02165553|Dietary Supplement|Hibiscus sabdariffa calyces extract as a cold drink|
16099747|NCT02165540|Other|Doula|A specially trained support person or doula will accompany the patient to offer physical and emotional support during the procedure.
16099748|NCT02165527|Procedure|Lunar iXDA scan|Subject will receive a total body scan taken by the Lunar iXDA. This scan will take approximately 8 minutes to complete. Following the scan, the computer of the Lunar iXDA will calculate the bone length.
16099749|NCT02165514|Procedure|Lunar iDXA x-ray scan|Subjects will lay either on their back or side depending whether subject has kyphosis or scoliosis. After the DEXA scan the computer will calculate the Cobb angle. The calculation of Cobb angle from the DEXA scan will be compared to the conventional spine x-ray.
16099750|NCT02165475|Behavioral|Biofeedback|
16099751|NCT02165475|Drug|Loperamide|
16099752|NCT02165475|Drug|Stool bulking agent (stericulia or isphagula husk)|
16099753|NCT02165475|Other|Combination of biofeedback and medical treatment|
16099754|NCT02165462|Other|Patients with haemophilia|Assessment of bilateral deficit phenomenon during dynamic plantar flexion task with a force platform (Kistler 9286 BA model, Kistler Instruments, Amherst, NY, USA)
16099755|NCT02165449|Drug|Ketamine|Approved FDA indications for ketamine include use as an adjunct in the induction and maintenance of general anesthesia and for procedural sedation. For general anesthesia, ketamine is given at dosages ranging from 1-2mg/kg and given either as bolus injection or run continuously (0.1 to 0.3mg/kg/min) in conjunction with another anesthetic or sedation agent. In this study, ketamine at a subanesthetic dose of 0.5mg/kg will be diluted in 60cc of normal saline and administered via a slow IV infusion over 40 minutes at each treatment session in patients while undergoing hemodynamic monitoring. When used in this manner, ketamine infusion does not induce general anesthesia or states of unconsciousness, and patients remain fully awake, responsive to commands, and do not lose respiratory drive.
16099756|NCT02165436|Other|Chewing gum|Subjective assessment - subjective assessment of abdominal pain and nausea.
16099757|NCT02165436|Other|Control|No intervention will be assessed for this group.
16099758|NCT02165423|Behavioral|myFAMI iPad application|
16099759|NCT02165410|Procedure|ASL-MRI|ASL MRI is a non-invasive technique without injection to measure rCBF at rest marking the intravascular water molecules and use it as an endogenous tracer. Premedication, if required, will concern autistic and mentally retarded subjects only.
16099760|NCT02165410|Procedure|Diffusion tensor imaging (diffusion MRI)|Diffusion MRI enables the mapping of the diffusion process of water molecules, which allows visualizing anatomical connections between different parts of the brain, noninvasively and on an individual basis. The sequence is acquired following clinical MRI sequences, while the child is still inside the MRI machine, with no further intervention applied.
16099761|NCT02165410|Procedure|Eye-tracking|Eye tracking is a non-invasive method that allows objectifying gaze parameters during presentation of stimuli on a computer screen. Children will be presented with a series of social and no social stimuli and are required to watch it, with no further intervention applied.
16099762|NCT02165410|Procedure|Cognitive profile|Children will be asked to perform certain tasks, adapted for their age.
16099763|NCT02165397|Drug|Ibrutinib|Participants will receive 420 mg of Ibrutinib orally.
16099766|NCT02165384|Device|Ear tube placement with the Hummingbird TTS|Using the Hummingbird TTS to make a myringotomy and deliver a tympanostomy tube across the tympanic membrane with one pass.
16099767|NCT02165371|Behavioral|Sinovuyo Caring Families Programme|"Goal of the program is reduction in child behavior problems in high-risk South African families. Program will be delivered to caregivers responsible for the wellbeing of the child.
~Program activities will be delivered over 12 weekly group sessions with additional individualized in-home sessions. The groups (n = 15 participants per group) will meet weekly with community facilitators (n = 2 per group). Parenting skills will be developed during the sessions through role-plays, group-discussion, storytelling, and home practice activities.
~The program is manualized in isiXhosa."
16099768|NCT02165345|Drug|Tocilizumab|162 mg tocilizumab will be administered by SC injection at the following intervals: pJIA participants less than (<) 30 kilograms (kg): every 3 weeks; pJIA participants greater than or equal to (>=) 30 kg: every 2 weeks; sJIA participants <30 kg: every 2 weeks; sJIA participants >/= 30 kg: once weekly
16099769|NCT02165332|Drug|Part 1: SAD RO7033877|Single dose
16099770|NCT02165332|Drug|Part 1: SAD placebo|Single dose
16099771|NCT02165332|Drug|Part 2: Treatment A, RO7033877|Single dose RO7033877 and moxifloxacin placebo
16099772|NCT02165332|Drug|Part 2: Treatment B, RO7033877|Single dose RO7033877 and moxifloxacin placebo
16099773|NCT02165332|Drug|Part 2: Treatment C, moxifloxacin|Single dose moxifloxacin and RO7033877 placebo
16099774|NCT02165332|Drug|Part 2: Treatment D, RO7033877 and moxifloxacin placebo|Single dose moxifloxacin placebo and RO7033877 placebo
16099775|NCT02165319|Device|Barrel|Barrel-shaped endotracheal tube will be used during general anesthesia.
16099776|NCT02165319|Device|Tapered|Tapered-shaped tube will be used during general anesthesia.
16099777|NCT02165306|Behavioral|Motivational Interviewing (MI)|"A multifaceted intervention program was used to improve adherence and clinical outcomes in epileptic patients. However, this study mainly focused on behavioral treatment in the patients.
~Patient's intervention A three-week session will perform to improve medication adherence in patients in the intervention group. Face to face introductory motivational interviews (MI) will conduct to resolve patient ambivalence about change.
~Besides providingthe intervention for the patients, the health care team and the patient's family member will receive a brief intervention.All GPs and nurses as well as patients' family members participate in a single session MI with the same procedure"
16099778|NCT02165306|Behavioral|Routine counseling|All participants of the study in both group receive the Standard Care. Usually, patients in clinics receive a one-time session of brief advice to use medications regularly lasting approximately 5 minutes and deliver by nurse or physician. Some issues rise in this short session including coexisting diseases, the history of drug use, current disease and advice about the health risks of irregular medication use.
16099779|NCT02165293|Drug|RO7033877 + Bronchoscopy|Days 1, 2, and 3: 2.5 mg/kg RO7033877 infused IV over 2 hours, every 8 hours for a total of 7 doses; BAL procedure on Day 3.
16099780|NCT02165280|Behavioral|Guided IMagery (GIM)|It's a program of directed thoughts and suggestions that guide your imagination to a relaxed and focused state.
16099781|NCT02165267|Biological|VRC01|Administered IV in 100 mL of normal saline (Sodium Chloride for Injection 0.9%, USP) or administered SC by needle and syringe injection.
16099782|NCT02165267|Biological|SC placebo for VRC01|Sterile, buffered aqueous solution of 25 mM Sodium Citrate, 50 mM Sodium Chloride, 150 mM L-Arginine Hydrochloride, 10% Dextran 40, and 0.005% Polysorbate 80 at pH 5.8 administered SC by needle and syringe injection
16099783|NCT02165267|Biological|IV placebo for VRC01|Sodium Chloride for Injection 0.9%, USP administered IV in 100 mL of normal saline (Sodium Chloride for Injection 0.9%, USP)
16099784|NCT02165254|Behavioral|PLUS|1 hour tai chi session 3 times a week (weeks 1-12), to twice a week (week 13-16), and every other week (week 17-26) for a total of 24 weeks
16099785|NCT02165254|Behavioral|LITE|1 hour tai chi session 3 times a week (weeks 1-12)
16099786|NCT02165228|Behavioral|Mindfulness-based stress reduction|Stress reduction class and behavioral intervention
16099787|NCT02165228|Behavioral|Nutrition Enhancement|Nutrition education class and behavioral intervention
16099788|NCT02165215|Drug|Etrolizumab|Participants will receive 105 mg etrolizumab SC injection Q4W.
16099789|NCT02165215|Drug|Placebo|Participants will receive placebo (matched to etrolizumab) SC injection Q4W.
16099790|NCT02165202|Drug|Rilpivirine|Rilpivirine (TMC278), a non-nucleoside reverse transcriptase inhibitor (NNRTI) is a substituted diaryl-pyrimidine (DAPY) derivative with potent antiviral activity against HIV. It is approved by the US FDA for once daily oral administration and is effective as part of treatment for ARV-na'ive HIV-infected patients as rilpivirine 25 mg capsules. It is also co-formulated with TDF and FTC for use as a once- daily single fixed-dose combination (Complera™).
16099791|NCT02165202|Drug|Placebo|Participants randomized to the placebo arm will receive oral placebo capsules prior to injection of saline solution (0.9%NaCI). Participants will be observed while taking the study product by site staff on approximately six occasions during the first two weeks of the oral run-in at Week 0 (Enrollment), at Week 2 (Oral Run-in Safety Visit), and on four separate DOT visits between Weeks 0 and 2. Cervicovaginal and rectal fluid will be collected for PK studies at a single follow-up visit.
16099792|NCT02165189|Drug|Simeprevir|Participants will be administered simeprevir capsule 150 mg orally once daily up to 12 weeks.
16099793|NCT02165189|Drug|Sofosbuvir|Participants will be administered sofosbuvir 400 mg tablet orally once daily up to 12 weeks.
16099794|NCT02165189|Drug|Ribavirin|Participants will be administered ribavirin 2 x 200 mg tablets (for participants weighing less than 75 kilogram ([kg]) or 3 x 200 mg tablets (for participants weighing more than 75 kg) orally once daily up to 12 weeks.
16099795|NCT02165189|Drug|Simeprevir|Participants will be administered simeprevir capsule 150 mg orally once daily up to 24 weeks.
16099796|NCT02165189|Drug|Sofosbuvir|Participants will be administered sofosbuvir 400 mg tablet orally once daily up to 24 weeks.
16099797|NCT02165176|Drug|Oral cannabis|
16099798|NCT02165163|Other|Balance Training|"Balance training will be conducted individually two times per week for 4 weeks. Each training session will include virtual reality tasks such as ankle reaching and obstacle crossing using a virtual obstacle shown on a computer screen. Each session will last 30 - 45 minutes."
16099799|NCT02165150|Other|Wheelchair-bound Senior Elastic Band exercise program|three times per week, 40 minutes per practice
16099800|NCT02165124|Device|Artificial Embolization Device|Embosphere Microspheres
16099801|NCT02165111|Drug|Onabotulinumtoxin A|
16099802|NCT02165111|Drug|sterile saline solution|
16099803|NCT02165098|Drug|Cariprazine prolonged release tablet A|Cariprazine prolonged release tablet A - fasted
16099804|NCT02165098|Drug|Cariprazine prolonged release tablet B|Cariprazine prolonged release tablet B - fasted
16099805|NCT02165098|Drug|Cariprazine capsule|Cariprazine capsule - fasted
16099806|NCT02165098|Drug|Cariprazine PR tablet A|Cariprazine Prolonged Release tablet A - fed
16099807|NCT02165098|Drug|Cariprazine PR tablet B|Cariprazine Prolonged Release tablet B - fed
16099808|NCT02165046|Drug|Budesonide|
16099809|NCT02165046|Drug|Procaterol|
16099810|NCT02165033|Drug|Budesonide/Procaterol 180/10 X 4 puffs|Budesonide/Procaterol 180/10mcg, 4 puffs, Repeated dose
16099811|NCT02165020|Device|Hyaluronic acid (Macrolane VRF 30®, Q-MED)|"One injection of 3 to 10 cc of hyaluronic acid (Macrolane VRF 30®, Q-MED) introduced in the perirectal fat between the rectum and the prostate in connection with an ultrasound.
~The injection is performed under local anesthesia (with Lidocaine) and ultrasound guidance, using a 16 gauge needle."
16099812|NCT02165007|Drug|peripheral blood stem cell graft that are CD34+ selected|The preparatory regimen will consist of Hydroxyurea from Days -50 to -22, Alemtuzumab from days -21 to -19 (test dose Alemtuzumab on day -22), Fludarabine days -8 to -4, Thiotepa Day -4, Melphalan day -3 to -2 (Table 4a). In patients with intolerance to or have received alemtuzumab in the prior 6 months, alemtuzumab will be replaced with rabbit ATG on days -10 through -7, followed by infusion of a peripheral blood stem cell graft collected from haploidentical family donors that are CD34+ positively selected using the CliniMACS device. Sirolimus will be used for GVHD prophylaxis and given for 9 months post-transplant and then tapered off by one year.
16099813|NCT02164981|Drug|sodium nitroprusside|intravenous
16099814|NCT02164981|Other|Placebo|Placebo
16099815|NCT02164955|Drug|IMNOVID|IMNOVID (pomalidomide) as prescribed in routine clinical practice
16099816|NCT02164929|Procedure|TAP block|
16099817|NCT02164929|Procedure|Epidural|
16099818|NCT02164929|Procedure|Paravertebral block|
16099819|NCT02164929|Drug|Acetaminophen 1g IV|
16099820|NCT02164929|Drug|Dexamethasone 4mg|
16099821|NCT02164929|Drug|Midazolam up to 2mg|
16099822|NCT02164929|Drug|Propofol 1-2.5 mg/kg|
16099823|NCT02164929|Drug|Sevoflurane to keep a bispectral index of between 40-60|
16099824|NCT02164929|Drug|Local infiltration with 10 mL of plain ropivacaine 0.25%|
16099825|NCT02164929|Drug|Lidocaine|1.5% lidocaine
16099826|NCT02164929|Drug|Epinephrine|1:200,000 epinephrine
16099827|NCT02164929|Drug|Hydromorphone|400-800 mcg Hydromorphone will be given preoperatively
16099828|NCT02164916|Biological|cetuximab|Given IV
16099829|NCT02164916|Drug|irinotecan hydrochloride|Given IV
16099830|NCT02164916|Drug|vemurafenib|Given PO
16099831|NCT02164903|Other|QoL Survey Booklet|
16099832|NCT02164890|Other|micafungin|This is a pharmacokinetic study where a total number of 14 blood samples will be drawn per patient. Clinical and biological data will be concomitantly collected.
16099833|NCT02164877|Drug|pectin|Patients allocated to experiment group will receive 15g pectin each day
16099834|NCT02164864|Drug|Dabigatran Etexilate 110mg|Active treatment
16099835|NCT02164864|Drug|Warfarin 3mg|Active comparator
16099836|NCT02164864|Drug|Aspirin|Active comparator
16099837|NCT02164864|Drug|Dabigatran Etexilate 150mg|Active treatment
16099838|NCT02164864|Drug|Clopidogrel or Ticagrelor|Active comparator
16099839|NCT02164864|Drug|Clopidogrel or Ticagrelor|Active comparator
16099840|NCT02164864|Drug|Warfarin 5mg|Active comparator
16099841|NCT02164864|Drug|Clopidogrel or Ticagrelor|Active comparator
16099842|NCT02164864|Drug|Warfarin 1mg|Active comparator
16099843|NCT02164838|Drug|Axitinib|
16099844|NCT02164825|Drug|Ropivacaine perineural injection|Ultrasound guided single-shot femoral nerve block
16099845|NCT02164825|Drug|morphine and ropivacaine|Continuous epidural analgesic perfusion Epidural perfusion with morphine and ropivacaine.
16099846|NCT02164812|Drug|Moxifloxacin|
16099847|NCT02164812|Drug|Placebo|
16099848|NCT02164812|Drug|Efavirenz|
16099849|NCT02164773|Drug|Magnesium Sulfate|use of 50mg magnesium sulfate in caudal analgesia added to 1ml/kg of 0.25% of bupivacaine in children undergoing lower abdominal surgery for prevention of postoperative emergence agitation.
16099850|NCT02164773|Drug|0.9%normal saline|use of 1ml of 0.9%normal saline added to 1ml/kg of 0.25% of bupivacaine in the caudal block as placebo to compare with active comparator.
16099851|NCT02164760|Device|Novomaix dermal substitute in combination with STSG|Novomaix dermal substitute in combination with STSG
16099852|NCT02164747|Device|Residents of nursing homes with telemedicine after implementation of telemedicine|
16099853|NCT02164734|Device|Endotracheal intubation|
16099854|NCT02164734|Device|Laryngeal mask airway|
16099855|NCT02164734|Drug|remifentanil|additional premedication in the endotracheal intubation/INSURE arm
16099856|NCT02164721|Device|Three-lead CRT-D (Defibrillator)|The three-lead CRT-D (Defibrillator) will consist of a pulse generator, a right atrial lead, a right ventricular lead and a left ventricular lead.
16099857|NCT02164708|Behavioral|Mindfulness Meditation|"The program progressively trained students in mindfulness of breathing, a form of meditation frequently employed secularly. The tutorials were held on campus five times weekly, led by a faculty member and a graduate student who were trained, experienced MM practitioners. The tutorials were one hour in duration and typically involved 40-45 minutes of guided MM followed by a question-answer period that addressed recent research findings. Program participation required attendance at one tutorial per week, and participants were encouraged to maintain autonomous MM practice."
16099858|NCT02164695|Procedure|PPCI plus RIPC|All patients will be prepared with an upper-arm blood pressure cuff before arterial puncture (contralateral in case of radial access). In patients allocated into PPCI plus RIPC group, the protocol will be started immediately after cuff preparation. Upper-arm will be exposed to 4 cycles of ischemia/reperfusion, each obtained by 5 min cuff inflation at 200mmHg, followed by 5 min complete deflation.
16099859|NCT02164695|Procedure|PPCI only|All patients randomized to PPCI only arm, the blood pressure cuff will be applied to the arm or the calf but will not be inflated.
16099860|NCT02164682|Procedure|IV PCA group|The IV PCA is performed by injecting fentanyl 15 mcg/kg with the following regimen
16099861|NCT02164682|Procedure|IV PCA+ caudal block group|The IV PCA is performed by injecting fentanyl 15 mcg/kg with the following regimen + caudal block was 0.15% ropivacaine 1.2 cc/kg; a total volume of 100 cc, basal 2 cc, bolus 0.5 cc, and lockout time 15 minutes.)
16099862|NCT02164656|Behavioral|mindfulness for smokers|
16099863|NCT02164643|Drug|Flutemetamol (18F)|
16099864|NCT02164643|Drug|Florbetapir (18F)|
16099865|NCT02164630|Behavioral|Hope Therapy|Hope therapy is designed to address key components of hope theory through augmentation of hopeful thinking and enhancement of goal-directed activities. Training focuses on effective goal setting, mobilization of internal resources to reach goals, identification of resilience factors to formulate hopeful thinking, and enhancing maintenance of future goal development.
16099866|NCT02164630|Other|Pain Education|Pain Education is aimed to increase understanding of TMD symptomatology and etiology, as well as provide general education on pain, lifestyle management, and effective pain communication methods.
16099867|NCT02164617|Other|Wheelchair-bound Senior Elastic Band exercise program (WSEB)|Wheelchair-bound Senior Elastic Band exercise program (WSEB) three times per week, 40 minutes per practice
16099868|NCT02164604|Drug|intravitreal injection of 0.03ml ranibizumab|
16099869|NCT02164578|Drug|Rivaroxaban|
16099870|NCT02164578|Drug|Aspirin|
16099871|NCT02164565|Drug|Tranexamic Acid (TXA) treatment|Tranexamic Acid (TXA) treatment
16099872|NCT02164565|Drug|control grup: without Tranexamic Acid (TXA) treatment.|control grup: without Tranexamic Acid (TXA) treatment.
16099873|NCT02164552|Dietary Supplement|Vitamin D3 pills|Dietary supplement
16099874|NCT02164552|Other|Placebo pills|Placebo pills similar in appearance and shape but without vitamin D
16099875|NCT02164539|Drug|FF|Fluticasone furoate is available as fluticasone furoate inhalation powder (100 mcg per blister), combination of fluticasone furoate/umeclidinium bromide inhalation powder (fluticasone furoate: 100 mcg per blister, umeclidinium bromide: 15.6, 62.5, 125, or 250 mcg per blister) and combination of fluticasone furoate/vilanterol inhalation powder (fluticasone furoate: 100 mcg per blister, vilanterol: 25 mcg per blister)
16099876|NCT02164539|Drug|UMEC|Umeclidinium bromide is available as combination of fluticasone furoate/umeclidinium bromide inhalation powder (fluticasone furoate: 100 mcg per blister, umeclidinium bromide: 15.6, 62.5, 125, or 250 mcg per blister)
16099877|NCT02164539|Drug|VI|Vilanterol is available as vilanterol inhalation powder (25 mcg per blister) and combination of fluticasone furoate/vilanterol inhalation powder (fluticasone furoate: 100 mcg per blister, vilanterol: 25 mcg per blister)
16099878|NCT02164526|Other|Routine therapy|Routine therapy
16099879|NCT02164513|Drug|fluticasone furoate (FF)|FF will be available in combination as dry powder for inhalation as FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg and FF/VI 100 mcg/25 mcg
16099880|NCT02164513|Drug|vilanterol (VI)|VI will be available in combination as dry powder for inhalation as FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg, FF/VI 100 mcg/25 mcg and UMEC/VI 62.5 mcg/25 mcg
16099881|NCT02164513|Drug|umeclidinium bromide (UMEC)|UMEC will be available in combination as dry powder for inhalation as FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg, and UMEC/VI 62.5 mcg/25 mcg
16099882|NCT02164500|Drug|Ruxolitinib|
16099883|NCT02164474|Behavioral|High-Intensity Interval Training|Specifically, individuals randomized to HIIT will begin the intervention with four intervals lasting 1-minute each at ~85-90% peak oxygen uptake [VO2peak] and increasing to 10 X 1-min intervals by day 10 of the intervention. Individuals randomized to moderate-intensity exercise condition will begin the intervention with 20 minutes of continuous activity at ~55-60% V02peak and gradually increase the duration to 50 minutes by day 10 of the intervention.
16099884|NCT02164461|Biological|ADXS11-001|
16099885|NCT02164448|Drug|the dexmedetomidine group|the dexmedetomidine group: dexmedetomidine infusion from induction of anesthesia to end of surgery
16099886|NCT02164448|Drug|the control group|saline infusion from induction of anesthesia to end of surgery
16099887|NCT02164435|Procedure|Renal Denervation (EnligHTN™) Renal artery ablation with the EnligHTN™ Renal Denervation System.|
16099888|NCT02164422|Drug|Guanfacine 3mg/day|3 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper.
16099889|NCT02164422|Drug|Guanfacine 1.5mg/day|1.5 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper.
16099890|NCT02164422|Drug|Placebo|
16099891|NCT02164409|Procedure|Endoscopy tissue collection|The investigational part of this study is the requirement for an additional biopsy from a site that is already being biopsied at the time of a routine endoscopy. Any patients who develop bleeding following their routine clinical biopsies will not undergo any additional research biopsies.
16099892|NCT02164396|Device|Spectacle Lens|Spectacle Lens Only
16099893|NCT02164396|Device|Habitual Soft Contact Lens|subject's own contact lens
16099894|NCT02164396|Device|Test Lens|senofilcon A or narafilcon A
16099895|NCT02164383|Drug|Nicotine patch|4-week starter kit of nicotine patch
16099896|NCT02164383|Behavioral|Cessation Counseling|5 brief counseling sessions
16099897|NCT02164383|Device|Mobile Games|
16099898|NCT02164357|Procedure|EVT (endovascular treatment )|
16099899|NCT02164357|Procedure|IVT (intravenous thrombolytic therapy)|
16099900|NCT02164344|Dietary Supplement|probiotics|probiotics (Streptococcus salivarius ssp. termophilus, Bifidobacterium breve, Bifidobacterium infantis, Bifidobacterium longum, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, Lactobacillus delbrueckii ssp. bulgaricus and Streptococcus faecium)
16099901|NCT02164331|Behavioral|JNC guideline training|Providers will receive a series of trainings on what the JNC guidelines for treating uncontrolled hypertensives are and strategies for meeting those guidelines.
16099902|NCT02164318|Other|Handgrip training|
16099903|NCT02164318|Drug|Nitroglycerin ointment|
16099904|NCT02164305|Other|Strengthening group|Open-chain exercise for rotator cuff and scapular muscles
16099905|NCT02164305|Other|Neuromuscular group|Closed-chain exercise for shoulder muscles
16099906|NCT02164305|Other|Control|No exercise training
16099907|NCT02164292|Procedure|ALPPS|Associating Liver Partition and Portal vein ligation for Staged hepatectomy
16099908|NCT02164279|Other|Urinary sample collection|urinary sample collection will be done at the inclusion visit for the assessment of the microalbuminuria ( < or > than 100mg/L)
16099909|NCT02164266|Drug|Placebo|Matching placebo daily oral administration
16099910|NCT02164266|Drug|RO6799477|Daily oral administration of RO6799477
16099911|NCT02164253|Drug|Deferiprone|30 mg/kg per day, oral use
16099912|NCT02164240|Drug|Sunitinib|Intervention Description: 3 days of once daily sunitinib alternating with 4 days of once daily regorafenib throughout each 28 day cycle. The starting dose level (level 1) is sunitinib 37.5 mg/d and regorafenib 120 mg/d, and doses will be escalated in subsequent cohorts following a classical 3+3 design up to sunitinib 50 mg/d and regorafenib 160 mg/d or until maximum tolerable dosage (MTD) and recommended phase II dose (RP2D) is determined. Number of Cycles: until progression or unacceptable toxicity develops.
16099913|NCT02164240|Drug|Regorafenib|Intervention Description: 3 days of once daily sunitinib alternating with 4 days of once daily regorafenib throughout each 28 day cycle. The starting dose level (level 1) is sunitinib 37.5 mg/d and regorafenib 120 mg/d, and doses will be escalated in subsequent cohorts following a classical 3+3 design up to sunitinib 50 mg/d and regorafenib 160 mg/d or until maximum tolerable dosage (MTD) and recommended phase II dose (RP2D) is determined. Number of Cycles: until progression or unacceptable toxicity develops.
16099914|NCT02164227|Other|Respiratory pattern|
16099915|NCT02164214|Drug|etanercept Treatment|
16099916|NCT02164188|Behavioral|Flourishing protocol|This intervention is based on relaxation, well-being promotion, meditation practices, positive psychology principles. The format is 1hour and half meetings during 8 weeks, and daily practices. MP3 audios are presented for daily practices.
16099917|NCT02164175|Device|HeRO Graft implant for dialysis access|End Stage Renal Disease patients who receive HeRO Graft implant for dialysis access
16099918|NCT02164162|Device|Lokomat (Hocoma, Zurich, Switzerland)|Patients allocated to the Experimental group performed a Robotic Assistested Gait Training by means of the Lokomat. The Lokomat is robotic device set up as an exoskeleton on the lower limbs of the patient. The system uses a dynamic body weight-support system to support he participant above a motorized treadmill synchronized with the Lokomat.
16099919|NCT02164162|Other|Conventional physical treatment|Patients allocated to the Control Group performed a general exercise program and a conventional gait training. The general exercise program consisted in cardiovascular warm-up exercises, muscle stretching exercises, active-assisted or active isometric and isotonic exercises for the main muscles of the trunk and limbs, relaxation exercises, coordination and dual task activities and balance exercises. The conventional gait therapy was based on the proprioceptive neuromuscular facilitation (PNF) concept (lasting 30 minutes), with rhythmic initiation, slow reversal, and agonistic reversal exercises applied to the pelvic region, each 10 minutes long. The same trained therapist treated all the patients in this group and standardized the duration of each part of the treatment.
16099920|NCT02164149|Other|Patients with primary colon cancer|CT scan two days after surgery
16099921|NCT02164136|Procedure|L-PANP-TME|
16099922|NCT02164136|Procedure|O-PANP-TME|
16099923|NCT02164123|Other|Spinal mobilization|Experimental group
16099924|NCT02164123|Other|Spinal Mobilization II|Active comparator group
16099925|NCT02164123|Other|Placebo|Placebo group
16099926|NCT02164110|Biological|Euvichol|"Number of doses and intervals: two doses/Weeks 0 and 2
~Method of administration: oral administration
~Dose of drug to be administered: 1.5 mL/dose"
16099927|NCT02164110|Biological|Shanchol|"Number of doses and intervals: two doses/Weeks 0 and 2
~Method of administration: oral administration
~Dose of drug to be administered: 1.5 mL/dose"
16099928|NCT02164097|Drug|ODSH|
16099929|NCT02164084|Drug|SB204|SB204 Gel with hydrogel
16099930|NCT02164084|Drug|Vehicle Gel|Vehicle Gel with hydrogel
16099931|NCT02164071|Other|Geriatric Assessment of Health Status Scale administration|Scale will be administered to all patients (3 cohorts) at baseline and then after 5 and not more than 15 days
16099932|NCT02164058|Device|TandemHeart System|
16099933|NCT02164058|Procedure|Percutaneous coronary intervention|
16099934|NCT02164045|Drug|BMS-663068|BMS-663068
16099935|NCT02164032|Drug|Intranasal insulin administration|intranasal insulin (40 IE) Actrapid (100IE/mL); two 0.1 ml puffs per nostril) or placebo (insulin dilution buffer Novo Nordisk; two 0.1 ml puffs per nostril) four times a day (in total 160 IE Actrapid per day) before each main meal and before going to bed. 40 IE IN insulin enhances insulin concentration in the CSF without any changes in systemic insulin and glucose concentration, and no risk for hypoglycemia
16099936|NCT02164032|Drug|Insulin Dilution Buffer (Novo Nordisk)|intranasal insulin (40 IE) Actrapid (100IE/mL); two 0.1 ml puffs per nostril) or placebo (insulin dilution buffer Novo Nordisk; two 0.1 ml puffs per nostril) four times a day (in total 160 IE Actrapid per day) before each main meal and before going to bed. 40 IE IN insulin enhances insulin concentration in the CSF without any changes in systemic insulin and glucose concentration, and no risk for hypoglycemia
16099937|NCT02164032|Other|1H magnetic resonance spectroscopy|1H MR spectroscopy and imaging will be performed on the on on the 3.0-T Tim Trio System (Siemens Erlangen Germany). MR Spectroscopy and imaging measurements will last no more than 90 minutes all together.
16099938|NCT02164019|Procedure|long-stem cemented hemiarthroplasty (LSCH)|
16099939|NCT02164019|Procedure|intramedullary nailing (IMN)|
16099940|NCT02164019|Behavioral|questionnaires|
16099941|NCT02164006|Drug|TGR-1202 + brentuximab vedotin|TGR-1202 an oral daily dose with an IV infusion of brentuximab vedotin
16099942|NCT02163993|Drug|Galcanezumab|Administered SQ
16099943|NCT02163993|Drug|Placebo|Administered SQ
16099944|NCT02163980|Drug|Caudal ropivacaine + normal saline|
16099945|NCT02163980|Drug|Caudal ropivacaine + dexmedetomidine|
16099946|NCT02163967|Device|Cranial Electrical Stimulation Fisher-Wallace Stimulator (Model FW100)|low voltage alternating current transcranial electrical stimulation
16099947|NCT02163954|Drug|Ticagrelor|After randomization, an initial loading dose of ticagrelor (180 mg) was given and maintenance doses (ticagrelor 90 mg twice daily) was treated for 14 days.
16099948|NCT02163954|Drug|Clopidogrel|After randomization, an initial loading dose of clopidogrel (300 mg) was given and maintenance doses (clopidogrel 75 mg once daily) was treated for 14 days.
16099949|NCT02163941|Behavioral|Compassion Training|
16099950|NCT02163928|Other|Food-based intervention; increased fruits and vegetables|4-6 cups of fruits and vegetables daily for 8-weeks
16099951|NCT02163915|Drug|TAK-137|TAK-137 tablets
16099952|NCT02163915|Drug|TAK-137 Placebo|TAK-137 placebo-matching tablets
16099953|NCT02163902|Drug|ATX-101|Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events
16099954|NCT02163902|Drug|Placebo|Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements, recording of adverse events
16099955|NCT02163876|Drug|HuCNS-SC cells|surgery arm
16099956|NCT02163863|Device|Femoropopliteal stenting|
16099957|NCT02163850|Device|Direct Flow Medical|Direct Flow Medical Transcatheter Aortic Valve Replacement System (TAVR)
16099958|NCT02163850|Device|Commercially Available|Medtronic CoreValve Transcatheter Aortic Valve Replacement System (TAVR) or Edwards SAPIEN Transcatheter Aortic Valve Replacement System (TAVR)
16099959|NCT02163837|Drug|rifaximine|
16099960|NCT02163824|Drug|KPI-121 0.25%|KPI-121 drug product will be supplied as 0.25% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
16099961|NCT02163824|Drug|KPI-121 1.0%|KPI-121 drug product will be supplied as 1.0% as a suspension in identically packaged opaque dropper bottles. KPI-121 drug product is a sterile, aqueous, submicron suspension of loteprednol etabonate.
16099962|NCT02163824|Drug|Vehicle of KPI-121 0.25%|Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
16099963|NCT02163824|Drug|Vehicle of KPI-121 1.0%|Placebo control arms will receive the same bottles containing vehicle of KPI-121 including all components at the concentrations used in the KPI-121 drug product with the exception of the active component, loteprednol etabonate.
16099964|NCT02163811|Behavioral|VETPALS|"VETPALS is an adaption of an empirically supported self-management program, PALS (Promoting Amputee Life Skills). The PALS program demonstrated improved physical and psychosocial functioning when delivered in community-based support groups for amputees, but this program has not been adapted for the needs of Veterans and implemented in the VA healthcare system.
~VETPALS is a five session course for people with life changes after amputation. The five sessions are held weekly, and are facilitated by a VA clinician in conjunction with a peer facilitator (Veteran with limb loss). Veterans receive all usual care."
16099965|NCT02163811|Behavioral|Individual Education Support Program|VETPALS facilitator provide post-amputation education materials from the Amputee Coalition, including First Step - A Guide for Adapting to Limb Loss and Side Step - A Guide to Preventing and Managing Diabetes and Its Complications. Veterans receive all usual care.
16099966|NCT02163798|Behavioral|12-week instructor-led Tai Chi training program|A 12-week (45 min per day, 5 days per week) instructor-led Tai Chi training program was conducted in the Tai Chi group. Of the 5 days of exercise, 3 days were led by qualified instructors, and 2 other days for self-practice. Each session consisted of a 10-min standard warm-up, 30-min of Tai Chi exercise, and 5-min cool down stretching. The modified 32 Yang-style Tai Chi Chuan was used, because it could be learned within a relatively short time, and has been widely promoted in HK community. An exercise log was used to record the actual implementation of the training (instructor-led & self-practice).
16099967|NCT02163798|Behavioral|12-week instructor-led brisk walking training program|A 12-week (45 min per day, 5 days per week) instructor-led brisk walking training program was conducted in the walking group. Of the 5 days of exercise, 3 days were led by qualified instructors, and 2 other days for self-practice. Each session consisted of a 10-min standard warm-up, 30-min of walking exercise, and 5-min cool down stretching. An exercise log was used to record the actual implementation of the training (instructor-led & self-practice).
16099968|NCT02163785|Procedure|Abdominoperineal extra-elevators rectal resection for low lying rectal cancer|Abdominoperineal extra-elevators rectal resection for low lying rectal cancer involving anal sphincter complex
16099969|NCT02163772|Procedure|Intracordal hyaluronate injection|
16099970|NCT02163759|Drug|Adalimumab|Adalimumab 160 milligrams (mg) will be administered subcutaneously (SC) at Week 0; 80 mg SC at Week 2; 40 mg SC at Weeks 4, 6, and 8.
16099971|NCT02163759|Other|Adalimumab Placebo|Placebo matching to adalimumab will be administered SC at Weeks 0, 2, 4, 6, and 8.
16099972|NCT02163759|Drug|Etrolizumab|Etrolizumab 105 mg will be administered SC every 4 weeks (Q4W) up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]).
16099973|NCT02163759|Other|Etrolizumab Placebo|Placebo matching to etrolizumab will be administered SC once every 4 weeks (Q4W) up to Week 12 (at Weeks 0 [Day 1], 4, 8, and 12 [clinical remitters only]).
16099974|NCT02163746|Procedure|CO2 (carbon dioxide) laser|
16099975|NCT02163746|Procedure|Surgical Deroofing|
16099976|NCT02163733|Drug|AZD9291 tablets|AZD9291 tablets: Part A 80mg od, days 1 and 10 only. Part B 80mg od for 12 months.
16099977|NCT02163733|Procedure|Pharmacokinetic sampling - AZD9291|Blood samples taken pre and post dosing of AZD9291 following either a period of fasting or consumption of a meal.
16099978|NCT02163733|Other|Dietary Fasted|Fasted from 10 hours prior to dosing with 80mg AZD9291 tablet and 4 hours after dosing
16099979|NCT02163733|Other|Dietary High Fat|Allocated breakfast prior to dosing with 80mg AZD9291 tablet
16099980|NCT02163733|Procedure|Pharmacokinetic sampling - AZ5140 and AZ7550|Blood samples taken pre and post dosing of AZD9291 following either a period of fasting or consumption of a meal.
16099981|NCT02163720|Drug|Yondelis®-Caelyx®|Observation of Yondelis®-Caelyx® administration
16099982|NCT02163707|Drug|Psilocybin|Dose 1: 0.3 mg/kg (approximately 20mg/70kg) Dose 2: 0.45 mg/kg (approximately 30 mg/70 kg) Dose 3: 0.6 mg/kg (approximately 40 mg/70 kg)
16099983|NCT02163694|Drug|Paclitaxel|Intravenous (IV) Infusion
16099984|NCT02163694|Drug|Veliparib|Capsule; Oral
16099985|NCT02163694|Drug|Carboplatin|Intravenous (IV) Infusion
16099986|NCT02163694|Drug|Veliparib Placebo|Capsule; Oral
16100086|NCT02162927|Dietary Supplement|Potassium Chloride (placebo)|This pill must be taken on an empty stomach (2-3 hours after eating) and must be taken about 2-3 hours before exercise.
16099987|NCT02163681|Drug|Hyperpolarized Helium-3 MRI of the chest|hyperpolarized helium-3 is an inhaled gaseous contrast agent for MRI and permits the acquisition of high quality imagined of lung ventilation.
16099988|NCT02163668|Other|Yoga Group|8 months of Yoga training
16099989|NCT02163655|Drug|FUROSEMIDE|Furosemide, 20mg pills, will be administered every 24 houras, for a maximum of five days
16099990|NCT02163655|Drug|Placebo|Placebo pills, identical to the intervention (furosemide pills), will be administered every 24 hour for a maximum of five days
16099991|NCT02163642|Device|Cyranose® 320|Detection of patterns of specific Volatile Organic Compounds in exhaled air
16099992|NCT02163629|Behavioral|Stress management|
16099993|NCT02163616|Drug|Misoprostol|800 mcg of sublingual misoprostol
16099994|NCT02163603|Procedure|Pelvic osteotomy|
16099995|NCT02163590|Other|2Hz mobilisation|This intervention will be applied for 3 sets of 1 minute, with 1 minute rest period in between each set.
16099996|NCT02163590|Other|0,5Hz mobilisation|This intervention will be applied for 3 sets of 1 minute, with 1 minute rest period in between each set.
16099997|NCT02163590|Other|Placebo|Intervention that mimics the experimental procedures
16099998|NCT02163577|Biological|burosumab|solution for SC injection
16099999|NCT02163564|Behavioral|Cognitive Behavioral Therapy for Insomnia|A non-pharmacological therapy for insomnia based on behavior and cognitive therapy approaches
16100000|NCT02163538|Device|articulating Enseal|Vessel-sealing device used for laparoscopic hysterectomy.
16100001|NCT02163538|Device|Ligasure device|Vessel-sealing device used for laparoscopic hysterectomy.
16100002|NCT02163525|Procedure|Global Fibroid Ablation (GFA)|GFA is radiofrequency ablation of fibroids. This is a laparoscopic procedure whereby a radiofrequency probe is inserted into the fibroid under laparoscopic and ultrasound guidance. Each fibroid is heated to temperatures averaging 95 deg C. The fibroid undergoes coagulative necrosis and shrinks and/or disappears.
16100003|NCT02163525|Procedure|Abdominal or Laparoscopic Myomectomy|Myomectomy is a procedure in which an incision is made into the uterus and the fibroids are surgically removed from the uterus. The uterine incision is closed with sutures. This procedure can be performed through an abdominal incision or via laparoscopy.
16100004|NCT02163525|Procedure|Uterine Artery Embolization (UAE)|UAE is a minimally invasive surgical procedure used to treat uterine fibroids. An embolic material is injected into the uterine artery(ies) to block blood flow to one or more fibroids. This procedure is performed by an interventional radiologist.
16100005|NCT02163499|Drug|Sodium Zirconium Cyclosilicate|Acute Phase Dosing: Sodium Zirconium Cyclosilicate 10 g three times daily (TID) for 24 to 72 Extended Dosing: Sodium Zirconium Cyclosilicate 5 g once daily (QD). Sodium Zirconium Cyclosilicate dose increased or decreased in increments/decrements of 5 g QD up to a maximum of 15 g QD or a minimum of 5 g every other day (QOD) based on i-STAT potassium measurements up to 12 months.
16100006|NCT02163486|Device|Group U (UNIQUE)|Before LMA-Unique was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LMA-Unique cuff.
16100007|NCT02163486|Device|I-GEL|"Before I-gel was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the I-GEL cuff.
~I-GEL: K-Y Jelly® is a registered trademark of Johnson and Johnson Inc"
16100008|NCT02163473|Procedure|Septic patients|The investigators will draw two sets of blood samples. One at baseline, 10 mL, and another, 24 hours later, 10 mL, for a total of 20 mL.
16100009|NCT02163473|Procedure|Healthy Control|The investigators will draw 10 mL, once, during baseline for a total of 10 mL among the healthy control group.
16100010|NCT02163460|Procedure|Drain|In group 1, a 4.8 mm diameter continuous closed-suction tubular drain (Medsharp Ind.Com.Prod.Hosp.Ltda - reg. MS (Ministério da Saúde [Health Ministry registry]): 80267170001) was placed between the aponeurosis and the subcutaneous tissue caudally to the incision.
16100011|NCT02163460|Procedure|Progressive Tension Sutures|Drains were not used in group 2, but separate absorbable polyglactin 920 2/0 sutures were placed from the subcutaneous mesh to the aponeurosis every 2 cm by means of the progressive tension suture (or Quilting Sutures) technique, as described by Pollock et al
16100012|NCT02163447|Drug|Monthly dihydroartemisinin-piperaquine (DP) for adult women during pregnancy|
16100013|NCT02163447|Drug|3 dose dihydroartemisinin-piperaquine (DP) for adult women during pregnancy|
16100014|NCT02163447|Drug|3 dose sulfadoxine-pyrimethamine (SP) for adult women during pregnancy|
16100015|NCT02163447|Drug|Monthly dihydroartemisinin-piperaquine (DP) for infants|
16100016|NCT02163447|Drug|3-monthly dihydroartemisinin-piperaquine (DP) for infants|
16100017|NCT02163434|Drug|Gabapentin|
16100018|NCT02163434|Drug|Metoclopramide|
16100019|NCT02163421|Drug|Vedolizumab SC|Vedolizumab injection, for subcutaneous use (vedolizumab SC)
16100020|NCT02163421|Drug|Vedolizumab IV|Vedolizumab injection, for intravenous use (vedolizumab IV)
16100021|NCT02163408|Other|MRI with/without contrast|Bilateral carotid plaque imaging at 3.0T. Conventional MRI scans with T1-, T2-weightings and scans using the developed techniques. MR contrast may be used in conventional protocol when it is needed to evaluate the performance of the developed techniques
16100022|NCT02163395|Device|FullCeram implant|FullCeram implantation
16100023|NCT02163382|Device|Neurovent Monitor XIII|Nasogastric tiube installation to monitor EAdi
16100024|NCT02163382|Device|Neurovent Monitor XIII|RIP jacket installation
16100025|NCT02163382|Device|Neurovent Monitor XIII|Ventilator change (if a different ventilator was used prior to the study).
16100026|NCT02163382|Device|Neurovent Monitor XIII|Determination of NAVA parametersVentilator
16100027|NCT02163382|Device|Neurovent Monitor XIII|Second period with conventional NIV settings
16100028|NCT02163369|Drug|Peppermint and Lavender Essential Oils|
16100029|NCT02163356|Drug|Fenretinide/LXS Oral Powder|Oral Powder
16100030|NCT02163356|Drug|Ketoconazole|Oral Tablet
16100031|NCT02163356|Drug|Vincristine|IV
16100032|NCT02163330|Drug|Acetazolamide|
16100033|NCT02163330|Drug|sugar pill|
16100034|NCT02163317|Radiation|stereotactic radiosurgery|Undergo MRI-guided focal SRS
16100035|NCT02163317|Device|magnetic resonance imaging|Undergo staging MRI with contrast
16100158|NCT02162485|Drug|Salmeterol/fluticasone Easyhaler with charcoal|
16100036|NCT02163317|Other|quality-of-life assessment|Quality of life scores will be summarized graphically and repeated measures of variance will be conducted to test for changes in scores over time
16100037|NCT02163317|Procedure|Serum Prostate Antigen Test|Test of the PSA protein in blood. The test will be run every three months for up to two years during the study.
16100038|NCT02163317|Procedure|Digital Rectal Exam|Exam of rectal health. Performed every three months for up to two years throughout the study.
16100039|NCT02163317|Behavioral|Expanded Prostate Cancer Index Composite|This survey measures a patient's function and bother after prostate cancer treatment. It will be analyzed using ANOVA using data collected every 6 months for up to 2 years of the study.
16100040|NCT02163304|Other|Sucrose|
16100041|NCT02163304|Other|Artificial Sweetner|
16100042|NCT02163304|Other|Tasteless Solution|
16100043|NCT02163291|Drug|paclitaxel liposome|S-1 40 mg/m2 bid d1-14 po and paclitaxel liposome 175mg/m2 d1 intravenously infusion for 3 hours, every 3 weeks. After 2 cycles' treatment, if clinical response is complete response（CR）,partial regression（PR） or stable disease（SD）, another 2 cycles is administered and operation is performed after the total 4 cycles. If response is progressive disease（PD）, chemotherapy is stopped and operation is performed.
16100044|NCT02163278|Drug|DBPR108|DBPR108 capsules in four doses beginning at 25 mg and rising to 600 mg.
16100045|NCT02163278|Drug|matching placebo|Matching placebo capsules in four doses beginning at 25 mg and rising to 600 mg.
16100046|NCT02163265|Procedure|Surgery|Patients suffering from Pectus excavatum Pectus carinatum will be treated surgically according to normal procedures
16100047|NCT02163252|Behavioral|Standard|
16100048|NCT02163252|Behavioral|Early Intervention|
16100049|NCT02163239|Device|Cannula and Blunt Obturator|The FloShield 10mm Endoscopic Cannula and Blunt Obturator will be used to maintain access to the peritoneal cavity during robot-assisted single site laparoscopic surgery
16100050|NCT02163226|Radiation|Hypofractionated Radiation Treatment|Participants receive standard hypofractionated regimen of 3 Gy x 10 fractions, 1 radiation treatment a day for 5 days in a row.
16100051|NCT02163226|Radiation|One Radiation Treatment|12 Gy x 1 fraction or 16 Gy x 1 fractions adaptively depending on the size of the metastases or gross tumor volume (GTV).
16100052|NCT02163226|Behavioral|Questionnaire|Questionnaire completion at months 1, 2, 3, 4, and 6 and then every 3 months after that for at least 3 years. Questionnaires ask about pain, pain relief, and quality of life.
16100053|NCT02163213|Other|Serum-derived bovine immunoglobulin protein isolate (SBI)|Serum-Derived Bovine Immunoglobulin /Protein Isolate (SBI) 5.0 g bid on Nutritional Status and intestinal functions in Subjects with IBS-D
16100054|NCT02163187|Device|Implantation of the InterStimTM|
16100055|NCT02163187|Behavioral|MSK BFI questionnaires|
16100056|NCT02163187|Behavioral|The Low Anterior Resection Score (LARS) questionnaires|
16100057|NCT02163187|Behavioral|The EuroQOL5D questionnaires|
16100058|NCT02163187|Behavioral|The Fecal incontinence Quality of Life Scale (FIQOL) questionnaires|
16100059|NCT02163174|Drug|Pentoxifylline (PTX)|Patients were randomly assigned to receive intravenous Pentoxifylline 5 mg/kg/hr for 6 hours on 6 successive days in addition to antibiotics
16100060|NCT02163174|Drug|Placebo|Patients were randomly assigned to receive intravenous normal saline 5 mg/kg/hr for 6 hours on 6 successive days as a placebo in addition to antibiotics.
16100061|NCT02163161|Drug|PF-04965842|Subjects will receive 4 x 100 mg PF 04965842 tablet under fasted conditions
16100062|NCT02163161|Drug|PF-04965842|Subjects will receive 400 mg PF 04965842 oral suspension under fasted conditions
16100063|NCT02163161|Drug|PF- 04965842|Subjects will receive 4 x 100 mg PF 04965842 tablet under fed conditions
16100064|NCT02163148|Behavioral|Massed speech exposure session|One session consisting of 4 speech exposures, each 5 minutes long.
16100065|NCT02163122|Procedure|Nasal Allergen Challenge|Cat allergen (FelD1) applied directly to the nasal tissues
16100066|NCT02163122|Other|Environmental Exposure Chamber|The mobile EEC (mEEC) is a movable facility, designed with clean-room technology, used to expose subjects to aeroallergens (in this trial, the allergen FelD1 from cats) at controlled, consistent airborne levels, similar to that experienced in subjects' daily lives.
16100067|NCT02163122|Biological|Cat allergen (FelD1)|
16100068|NCT02163083|Procedure|ICG|Improvement of detection of positive lymphnodes
16100069|NCT02163070|Dietary Supplement|whey drink,|consumption of 220 milliliters of whey drink three times a week,
16100070|NCT02163070|Dietary Supplement|whey drink fortified with vitaminE|consumption of 220 milliliters of whey drink fortified with 400 milligrams of vitamin E three times a week,
16100071|NCT02163070|Dietary Supplement|vitamin E|consumption of 400 milligrams of vitamin E three times a week,
16100072|NCT02163057|Biological|INO-3112|1.1 mL of INO-3112 (VGX-3100 + INO-9012) delivered intramuscularly (IM) followed immediately by electroporation (EP) with CELLECTRA™-5P device for a total of 4 doses of immunotherapy.
16100073|NCT02163057|Device|CELLECTRA™-5P|CELLECTRA™-5P device was used for EP following IM delivery of INO-3112 for a total of 4 doses of immunotherapy.
16100074|NCT02163031|Device|devices used in the coronary angiography|devices used in coronary angiography by left or right radial route
16100075|NCT02163018|Drug|HAL-MPE1|Subcutaneous administration of increasing doses of HAL-MPE1
16100076|NCT02163018|Drug|Placebo|Subcutaneous administration of increasing doses of placebo
16100077|NCT02163005|Drug|Gadolinium|-agent will be administered intravenously and a CT scan will be performed to evaluate contrast enhancement characteristics of the agent to assess its feasibility as an alternative to Iodine based contrast agents.
16100078|NCT02162992|Other|No intervention|Observational
16100079|NCT02162979|Drug|sildenafil|sildenafil 50mg BID for 2 weeks
16100080|NCT02162979|Drug|Placebo|
16100081|NCT02162966|Drug|High Dose Colistin|High Dose Colistin
16100082|NCT02162966|Drug|Standard Dose Colistin|Standard Dose Colistin
16100083|NCT02162940|Other|Visual analogue score|Visual analogue score vas used to evaluate pain.
16100084|NCT02162940|Other|The SF 36 test|The SF 36 test (SHORT FORM 36) was used to evaluate quality of life.
16100085|NCT02162927|Dietary Supplement|Dietary Nitrate|This pill must be taken on an empty stomach (2-3 hours after eating) and must be taken about 2-3 hours before exercise.
16100087|NCT02162914|Drug|Regorafenib/active|Subjects randomized to be treated with Regorafenib/active will receive once a day 160 mg po (four tablets of 40 mg) for 3 weeks of every 4 weeks cycle (3 weeks on and 1 week off) Duration of one cycle is 28 days
16100088|NCT02162914|Drug|Regorafenib/placebo|Subjects randomized to be treated with Regorafenib/placebo will receive once a day 160 mg po (four tablets of 40 mg) for 3 weeks of every 4 weeks cycle (3 weeks on and 1 week off) Duration of one cycle is 28 days
16100089|NCT02162901|Behavioral|Choice-Class with IVR Calls|The intervention for this arm consists of an educational program which is an adaptation of the 16 lessons from the original Diabetes Prevention Program, both Core and After-Core sessions. After attending one 2-hour class to be introduced to the program and set goals, these lessons are delivered to the participant through 22 Interactive Voice Response telephone call over a period of 12 months.
16100090|NCT02162901|Behavioral|Random-Class with IVR calls|The intervention for this arm consists of an educational program which is an adaptation of the 16 lessons from the original Diabetes Prevention Program, both Core and After-Core sessions. After attending one 2-hour class to be introduced to the program and set goals, these lessons are delivered to the participant through 22 Interactive Voice Response telephone calls over a period of 12 months.
16100091|NCT02162901|Behavioral|Random-Class only|The intervention for this arm consists of an educational program which is an adaptation of the 16 lessons from the original Diabetes Prevention Program, both Core and After-Core sessions. After attending one 2-hour class to be introduced to the program and set goals, these lessons are delivered to the participant through a printed workbook.
16100092|NCT02162901|Behavioral|Choice-DVD with IVR calls|The intervention for this arm consists of an educational program which is an adaptation of the 16 lessons from the original Diabetes Prevention Program, both Core and After-Core sessions. After watching a DVD at home to be introduced to the program and set goals, these lessons are delivered to the participant through 22 Interactive Voice Response telephone calls over a period of 12 months.
16100093|NCT02162901|Behavioral|Random-DVD with IVR calls|The intervention for this arm consists of an educational program which is an adaptation of the 16 lessons from the original Diabetes Prevention Program, both Core and After-Core sessions. After watching a DVD at home to be introduced to the program and set goals, these lessons are delivered to the participant through 22 Interactive Voice Response telephone calls over a period of 12 months.
16100094|NCT02162888|Drug|Test Product (Bendamustine)|
16100095|NCT02162875|Drug|Praziquantel|Six different treatment strategies with praziquantel
16100096|NCT02162862|Behavioral|Behavioral Counseling|
16100097|NCT02162862|Drug|bupropion-SR|
16100098|NCT02162849|Drug|Varenicline|Varenicline Dosing: 0.5 mg/day by mouth for Days 1-3; 0.5 mg twice a day for Days 4-7, and 1 mg twice a day thereafter.
16100099|NCT02162849|Drug|Nicotine Patch|Starting on Day 8, and then every day after that, participant applies 1, 21 mg nicotine patch for 11 weeks.
16100100|NCT02162849|Drug|Placebo Patch|Starting on Day 8, and then every day after that, participant applies 1 placebo patch each day for 11 weeks.
16100101|NCT02162849|Drug|Placebo Tablet|Participant takes placebo tablet 1-10 days after Visit 1. On Days 1-3, participant takes 1 dose of the placebo each morning. Starting on Day 4, and then every day after that, participant takes 1 dose in the morning and 1 dose in the evening.
16100102|NCT02162849|Behavioral|Questionnaires|Questionnaire completion 1 to 10 days before first study drug/placebo dose and on Days 8, 17, 24, 31, 38, 52, and 73. Questionnaires should take about 30-45 minutes total to complete. On Days 17, 24, 38, and 73, done over the phone.
16100103|NCT02162849|Behavioral|Counseling Sessions|Counseling sessions performed on Days 8, 17, 24, 31, 38, 52, and 73. On Days 17, 24, 38, and 73, done over the phone. These sessions take about 15 minutes each time.
16100104|NCT02162849|Other|Lab Session|Participant asked to watch slides. During the lab session, brain electrical activity checked with an electroencephalogram (EEG). Participant completes computer tasks, including questionnaires, that will measure emotions and attention level. These tasks should take about 90 minutes to complete. The lab session may last up to 2 hours.
16100105|NCT02162849|Other|Saliva Test|Saliva tested to check cotinine level at baseline, on Days 8 and 17, end of treatment visit, and at 3 months and 6 months after quitting smoking.
16100106|NCT02162836|Drug|JNJ-56021927|Participants will receive 8 capsules of JNJ-56021927, 240 milligram (mg) as single oral dose on Day 1. After participants will receive daily JNJ-56021927, 240 mg on Day 1 of Cycle 1 until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever comes first.
16100107|NCT02162823|Procedure|Pancreatic Surgery|Surgical removal of the pancreatic tumour (cancer) in the intervention group
16100108|NCT02162810|Drug|Prednisolone|In order to analyze the data, we will establish a chart which will show the degree of cosmetic appearance, incidences and degree of complications. This we be assessed on a mild to severe scale.
16100109|NCT02162810|Drug|placebo-controlled|In order to analyze the data, we will establish a chart which will show the degree of cosmetic appearance, incidences and degree of complications. This we be assessed on a mild to severe scale.
16100110|NCT02162797|Dietary Supplement|Zinc supplementation|Intervention group A: Patients who will orally receive zinc for 3 months.
16100111|NCT02162797|Dietary Supplement|Placebo supplementation|Intervention Group B: Patients who will orally receive a placebo for 3 months.
16100112|NCT02162784|Drug|Budesonide/Procaterol, 180/10mcg X1|one puff
16100113|NCT02162784|Drug|Budesonide/procaterol 180/10 mcg X 2|2 puffs
16100114|NCT02162784|Drug|Albuterol HFA MDI 100mcg X2|HFA MDI, 100mcg, 2 puffs
16100115|NCT02162771|Biological|Rituxan|
16100116|NCT02162771|Biological|CT-P10|
16100117|NCT02162771|Drug|Cyclophosphamide|
16100118|NCT02162771|Drug|Vincristine|
16100119|NCT02162771|Drug|Prednisone|
16100120|NCT02162758|Drug|Dexlansoprazole|Dexlansoprazole delayed-release capsules
16100121|NCT02162758|Drug|Dexlansoprazole Placebo|Dexlansoprazole placebo-matching capsules
16100122|NCT02162745|Drug|Isotonic solution (NaCl 0.9%)|
16100123|NCT02162745|Drug|Hypertonic solution (NaCl 3%)|
16100159|NCT02162485|Drug|Seretide Diskus|
16100160|NCT02162485|Drug|Seretide Diskus with charcoal|
16100161|NCT02162446|Drug|satoreotide trizoxetan|
16100162|NCT02162433|Drug|Normal Saline|to arms 2,4. Serves as the placebo.
16100163|NCT02162433|Drug|Dexmedetomidine|to arms 1,3
16100124|NCT02162732|Device|Guided Therapy|A total of 200 neuroblastoma, brain tumor, and rare tumor patients will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).
16100125|NCT02162719|Drug|Ipatasertib|Participants received ipatasertib orally 400 milligrams (mg) daily on Days 1-21 of each 28-day cycle.
16100126|NCT02162719|Drug|Paclitaxel|Participants received paclitaxel 80 milligrams per square meter (mg/m^2) intravenously (IV) on Days 1, 8, and 15 of each cycle.
16100127|NCT02162719|Drug|Placebo|Participants received oral placebo matched to ipatasertib, daily on Days 1-21 of each 28-day cycle.
16100128|NCT02162706|Other|Non intervention study|
16100129|NCT02162693|Biological|Mesenchymal progenitor cells|Administrated for intra-articular injection
16100130|NCT02162693|Biological|Sodium Hyaluronate|
16100131|NCT02162680|Drug|1% lidocaine|
16100132|NCT02162680|Drug|bacteriostatic normal saline (BNS)|
16100133|NCT02162667|Drug|Trastuzumab|Trastuzumab 6mg/kg is ongoing to be administered for both arms after 8mg/kg loading dose.
16100134|NCT02162654|Procedure|Remote ischemic preconditioning|The blood pressure cuff is inflated to 200 mmHg for 3 x 5 minutes with 5 minutes of reperfusion by complete cuff deflation each.
16100135|NCT02162654|Procedure|Sham preconditioning|The blood pressure cuff is inflated to 10 mmHg for 3 x 5 minutes with 5 minutes of complete cuff deflation each.
16100136|NCT02162641|Procedure|Sentinel lymph node biopsy|
16100137|NCT02162628|Device|Exair Prolapse Repair System|
16100138|NCT02162628|Procedure|Total Native Tissue Repair|
16100139|NCT02162615|Device|Restorelle Direct Fix A|
16100140|NCT02162615|Device|Restorelle Direct Fix P|
16100141|NCT02162615|Procedure|Native Tissue Repair Anterior|
16100142|NCT02162615|Procedure|Native Tissue Repair Posterior|
16100143|NCT02162589|Procedure|POEM|Per oral endoscopic myotomy
16100144|NCT02162576|Device|Propeller Health intervention|The Propeller intervention works through the provision of information to patients and their providers. With the Propeller sensor device in place, each actuation of a patient's rescue inhaler is recorded with an automatic time stamp and geographic location. Actuation data are then securely transmitted to Propeller Health where the information is also compiled into individual reports via mobile apps, online dashboards, email reports and text message reminders that are returned to the patient. This communication provides an ongoing assessment of their management based on the national guidelines, together with personalized information to help encourage and support self-management. Each participant was invited to share reports with his or her healthcare provider, but this was not required.
16100145|NCT02162563|Drug|FOLFOX/ FOLFIRI with bevacizumab|"FOLFIRI + bevacizumab Bevacizumab 5 mg/kg in 15-30 minutes i.v., followed by irinotecan 180 mg/m2 i.v. in 60 minutes together with leucovorin 400 mg/m2 i.v. in 120 minutes, followed by bolus 5-fluorouracil 400 mg/m2 within 4 minutes, all on day 1, followed by continuous infusion of 5-fluorouracil 2400 mg/m2 in 46 hours, every 2 weeks
~FOLFOX6 + bevacizumab Bevacizumab 5 mg/kg in 15-30 minutes i.v., followed by oxaliplatin 85 mg/m2 i.v. together with leucovorin 400 mg/m2 i.v. in 120 minutes, followed by bolus 5FU 400 mg/m2 within 4 minutes, all on day 1, followed by continuous infusion of 5-fluorouracil 2400 mg/m2 in 46 hours, every 2 weeks"
16100146|NCT02162563|Drug|FOLFOXIRI with bevacizumab|FOLFOXIRI + bevacizumab Bevacizumab 5 mg/kg in 15-30 minutes i.v., followed by irinotecan 165 mg/m2 i.v. in 60 minutes, followed by oxaliplatin 85 mg/m2 i.v. together with leucovorin 400 mg/m2 i.v. in 120 minutes, followed by continuous infusion of 5-fluorouracil 3200 mg/m2 in 46 hours, every 2 weeks
16100147|NCT02162563|Drug|FOLFOX/ FOLFIRI with panitumumab|"FOLFIRI + panitumumab Panitumumab 6 mg/kg i.v. (1st dose in 60 minutes, if well tolerated subsequent doses in 30 minutes), followed by irinotecan 180 mg/m2 i.v. in 60 minutes together with leucovorin 400 mg/m2 i.v. in 120 minutes, followed by bolus 5-fluorouracil 400 mg/m2 within 4 minutes, all on day 1, followed by continuous infusion of 5-fluorouracil 2400 mg/m2 in 46 hours, every 2 weeks
~FOLFOX6 + panitumumab Panitumumab 6 mg/kg i.v. (1st dose in 60 minutes, if well tolerated subsequent doses in 30 minutes), followed by oxaliplatin 85 mg/m2 i.v. together with leucovorin 400 mg/m2 i.v. in 120 minutes, and bolus 5FU 400 mg/m2 within 4 minutes, all on day 1, followed by continuous infusion of 5-fluorouracil 2400 mg/m2 in 46 hours, every 2 weeks"
16100148|NCT02162550|Drug|Bydureon|once weekly injection
16100149|NCT02162550|Drug|placebo|once weekly injection
16100150|NCT02162537|Drug|Cisplatin|Cisplatin 75 mg/m2 IV (with adequate hydration) on D1 every 3 weeks.
16100151|NCT02162537|Drug|Pemetrexed|500mg/m² IV(10 min. infusion, preceded by the usual folic acid, vitamin B12 and corticosteroid premedication)on D1 every 3 weeks
16100152|NCT02162537|Drug|Bevacizumab|7.5 mg/kg on D1 every 3 weeks. In case of eligibility for Bevacizumab, the latter will not be started until C2.
16100153|NCT02162537|Radiation|Cerebral Radiotherapy|Cerebral radiotherapy (encephalon in toto, 30 gy 10 sessions and 12 days) immediately after randomization before D1.If the number of brain metastases is less than or equal to 5 and less than or equal to 5 cm size, cerebral stereotactic radiotherapy condition may be proposed. The recommended interval between randomisation and D1 will be approximately 4 weeks.
16100154|NCT02162524|Behavioral|Aerobic Exercise|The exercise groups will be closely monitored during exercise sessions for six months in our exercise-training laboratory. The intensity will be 65% VO2peak and all exercise will occur on a treadmill. One exercise group will obtain 8 KKW (kcal/kg/week) over 3-4 sessions per week, which will result in each session lasting approximately 30 minutes. The other exercise group will obtain 20 KKW, performing 4-5 sessions per week for approximately 50-70 minutes per session. These groups are combined for this ancillary study.
16100155|NCT02162511|Device|CliniMACS CD34+ cell enrichment and T-cell depletion|
16100156|NCT02162498|Behavioral|Feeding buddies|"The Window of Opportunity program is implementing feeding buddies within their comprehensive programming. Their feeding buddies intervention targets all mothers at ANC for promoting health behaviors, especially exclusive breastfeeding.
~The NIH study is an implementation science award to evaluate the feeding buddies intervention, specifically among HIV positive recipients and evaluating the outcome of adherence to PMTCT recommendations."
16100157|NCT02162485|Drug|Salmeterol/fluticasone Easyhaler|
16100164|NCT02162420|Drug|Alemtuzumab|Alemtuzumab 0.2 mg/kg IV over 2 hours on days -10 to -6 from transplant.
16100165|NCT02162420|Drug|Fludarabine|Fludarabine 40 mg/m2 IV over 1 hour on days -6 to -2 from transplant.
16100166|NCT02162420|Drug|Cyclophosphamide|Cyclophosphamide 50 mg/kg IV over 2 hours on day -7 from transplant.
16100167|NCT02162420|Radiation|Total Body Irradiation|TBI 200 cGy as a single fraction on day -1 from transplant.
16100168|NCT02162420|Biological|Stem Cell Transplant|Stem cell transplant on day 0.
16100169|NCT02162420|Drug|Anti-thymocyte globulin|ATG (Thymoglobulin - Rabbit ) 3 mg/kg IV on days -5 to -3 from stem cell transplant.
16100170|NCT02162407|Drug|insulin detemir|Given as intravenous infusion (i.v.) over a period of 8 hours during euglycaemic clamp
16100171|NCT02162407|Drug|human soluble insulin|Given as intravenous infusion (i.v.) over a period of 8 hours during euglycaemic clamp
16100172|NCT02162394|Device|Observational ambulatory ECG monitoring|
16100173|NCT02162381|Drug|methylphenidate|a single dose of methylphenidate 10 mg to be taken orally in the morning
16100174|NCT02162381|Other|guidance|subjects will be given an explanation and advice about how to perform well in visual field testing
16100175|NCT02162355|Drug|GLPG0634 50 mg|2 tablets of 25 mg GLPG0634 once daily for 10 days
16100176|NCT02162355|Drug|GLPG0634 100 mg|1 tablet of 100 mg GLPG0634 once daily for 10 days
16100177|NCT02162355|Drug|GLPG0634 200 mg|2 tablets of 100 mg GLPG0634 once daily for 10 days
16100178|NCT02162355|Drug|Placebo|1 or 2 matching placebo tablets once daily for 10 days
16100179|NCT02162342|Other|Rehabilitative treatment|Surgical intervention, orthotics or injections of muscle/nerve medications as prescribed by the treating physician and unrelated to the study.
16100180|NCT02162329|Behavioral|Questionnaires|"Participants fill out several questionnaires asking questions about memory and concentration, mood, fatigue, how they have been feeling, and general quality of life. The questionnaires should take about 30 minutes to complete.
~Meditation Group and Wait-List Group also complete questionnaires at follow up visit."
16100181|NCT02162329|Procedure|Electroencephalography (EEG)|"Meditation Group and Wait-List Group: Electroencephalography (EEG) performed at baseline and at follow up visit. During EEG, 3 tests to check attention, short-term memory, and levels of emotions.
~Healthy Control Group: Electroencephalography (EEG) performed at study visit. During EEG, 3 tests to check attention, short-term memory, and levels of emotions."
16100182|NCT02162329|Procedure|Magnetic Resonance Imaging (fMRI|"Healthy Control Group: Magnetic resonance imaging (fMRI) scan performed.
~Meditation Group and Wait-List Group: Magnetic resonance imaging (fMRI) scan of brain performed at baseline and at follow up visit."
16100183|NCT02162329|Behavioral|Meditation Classes|Participants take part in up to 16 meditation classes for a total of 8 weeks. All sessions videotaped.
16100184|NCT02162316|Drug|Motilitone®|
16100185|NCT02162316|Drug|A-Cilin®, Clari® and Pantoline®|
16100186|NCT02162303|Drug|Colchicine|0.6 mg a day of active treatment or placebo for 24 weeks
16100187|NCT02162303|Drug|Placebo|Sugar,given once daily, over 6 months.To mimic active treatment
16100188|NCT02162290|Other|Interval exercise training|Exercise bouts in low and high intensities
16100189|NCT02162290|Other|Continuous exercise training|
16100190|NCT02162277|Device|diagnostic osteoporotic kit ( including 7 genes and 4 life styles)|Most osteoporotic patients want to know what kinds of life styles they should take care of. The device will help it.
16100191|NCT02162264|Drug|Donepezil Hydrochloride|Initial dose of 3 mg orally once daily. After 1-2 weeks, dosage increased to 5 mg orally once daily. After 4 or more weeks, dosage increased to 10 mg orally once daily for patients with severe dementia of Alzheimer's type. Dose reduced appropriately according to patient's symptoms.
16100192|NCT02162251|Drug|Donepezil Hydrochloride|Initial dose of 3 mg orally once daily. After 1-2 weeks, dosage increased to 5 mg orally once daily. After 4 or more weeks, dosage increased to 10 mg orally once daily for patients with severe dementia of Alzheimer's type. Dose reduced appropriately according to patient's symptoms.
16100193|NCT02162238|Device|LSF-filtering device|Device: LSF-filtering device LifeStraw Family is a water purification device that by means of hollow fibres removes solid particles (<0.5 Nephelometric Turbidity units turbidity reduction), bacteria (>Log 6 reduction), viruses (>Log 4 reduction) and cysts (>Log 3 reduction). Zinc enrichment is provided by a chamber housing a zinc releasing glass-plate that is placed annexed to the hollow fibre column. It is estimated that the LSF can provide about 5 mg of zinc/l of filtered water. By consuming daily a portion of 0.6 litres of enriched water, >100% of the age-specific estimated physiologic requirement would be covered, assuming a fractional absorption of 40%.
16100194|NCT02162225|Drug|beet juice (Unbeetable)|"Volunteers will drink a single 8 ounce bottle of beet juice (Unbeetable) per day for 28 days.
~On days 1,14, and 28, the juice will be drunk just prior to having blood drawn. Blood will also be drawn 1.5 hours after drinking the juice on days 1,14, and 28."
16100195|NCT02162212|Other|Optimized Shoulder Movement Program|"A trained physical therapist will see the participant for a max of 6 visits over the 3 month intervention; for baseline instruction, and at 2, 4, 6, and 8 weeks to progress and check subject adherence before a final check-out and testing visit at 3 months. Participants will perform 3 assigned stretching motions a min of 2 sets of 10 reps each and will be instructed in active shoulder movements with a dose based on the subject's measured activity count at baseline and with enough duration to increase it by 10%. Exercise: 10-15 minutes 2x/day for 3 month duration. Participants will log their activity."
16100196|NCT02162212|Other|ADA Guideline Instructed|The ADA guideline instructions are to include: blood sugar control (goal is A1c < 7.0%), physical activity (150 minutes/week of moderate intensity aerobic activity), foot care (examine feet daily, monofilament testing), and blood pressure control (goal is <130/80). Participants will receive a logbook to record daily outcomes. The goal of this intervention is to control for personal interactions with investigators and provide useful information for disease management but not provide intervention that likely would improve shoulder joint motion. The control group will be given instruction in the exercise program at the end of the 1 year study period.
16100197|NCT02162199|Drug|Debio 1450|Single sentinel dosing of 40 mg per unit capsules is planned to escalate from 80 mg to 160, 320, 480, 640 and 800 mg, per respective dosing group. Doses may be modified based on review of available safety and pharmacokinetic (PK) data.
16100322|NCT02161276|Drug|Placebo|Patients were asked to taken drugs 3 times a day, with each time 3 grains
16100198|NCT02162199|Drug|Placebo|Matching single sentinel dosing of placebo capsules is planned to escalate from 2 capsules to 4, 8, 12, 16 and 20 capsules, per respective dosing group. The number of capsules will match those delivering Debio 1450 for the group, as those doses may be modified based on review of available safety and pharmacokinetic (PK) data.
16100199|NCT02162173|Procedure|Endoscopy|Endoscopist performed white light endoscopy for polyp detection, then switch to dual focus NBI for characterization. Then probe-based confocal laser endomicroscopy was applied for characterization by another endoscopist independently and finally biopsy.
16100200|NCT02162160|Device|probiotic creme|Probiotic creme applied
16100201|NCT02162160|Drug|Placebo|Creme without probiotics applied in same manner
16100202|NCT02162134|Other|sugar free chewing gum|Sugar free chewing gum (orbit) was given to patients. They were asked to chew it 4 hours after surgery and continue to chew it 8 hourly for 20 to 25 min each time until oral feeding was started.
16100203|NCT02162134|Other|sugared chewing gum|Sugared chewing gum (singsong bubble gum) was given to patients. They were asked to chew it 4 hours after surgery and continue to chew it 8 hourly for 20 to 25 min each time until oral feeding was started.
16100204|NCT02162134|Drug|Tab. Midazolam 7.5 mg|Tab. Midazolam 7.5 mg will be given to all patients at night before surgery.
16100205|NCT02162134|Drug|Inj. Midazolam 0.7mg/kg 45 min before surgery|Inj . Midazolam 0.7 mg/kg given as premedication.
16100206|NCT02162134|Drug|Inj. Propofol 2.5mg/kg|It was given to induce anesthesia after 3 min of pre oxygenation.
16100207|NCT02162134|Drug|Inj. Atracurium 0.5 mg/kg|It was given to induce muscle relaxation during anesthesia.
16100208|NCT02162134|Drug|Sevoflurane 2.5 vol %|It was given to maintain anesthesia during surgery alongwith oxygen in air mixture
16100209|NCT02162134|Drug|Inj. Cefuroxime 1.5 g IV|It was given as prophylactic antibiotic. 2 doses given. 1st 30-60 min before surgery. 2nd 6 hours after surgery
16100210|NCT02162134|Drug|Inj. Ketorolac 30 mg IV|3 doses for analgesia. 1st immediate postoperative, 2nd at 8 hours postoperative and 3 rd at 16 hours postoperative period.
16100211|NCT02162134|Drug|Inj. Zantac 50mg IV|2 doses. 1st at immediate postoperative and 2nd 12 hours after surgery
16100212|NCT02162121|Procedure|Continuous lumbar plexus: stimulating catheter|"Perinervous stimulating catheter (Stimulong, Pajunk, Germany) will be insert in lumbar plexus through tuohy needle (18G, 100mm length). 15ml mepivacaine 1% are injected before the complete resolution of the spinal anesthesia."
16100213|NCT02162121|Procedure|Spinal Anesthesia|Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 15mg will be injected.
16100214|NCT02162121|Procedure|Local anesthetic infusion|Continuous infusion (Mini Rythmic Evolution, Micrel) of ropivacaine 0,2% at 3ml/h, bolus 3 ml, lockout time 15 min, 12 ml/h maximum dose through perinervous catheter until 3rd postoperative day
16100215|NCT02162121|Procedure|Intravenous analgesia|Ketorolac 30mg 3 times a day
16100216|NCT02162121|Procedure|Opioids rescue analgesia|Buprenorphine 0,2mg twice a day if VAS>4
16100217|NCT02162121|Drug|Mepivacaine 1%|
16100218|NCT02162121|Drug|Levobupivacaine 0,5%|
16100219|NCT02162121|Drug|Ropivacaine 0,2%|
16100220|NCT02162121|Drug|Ketorolac 30mg|
16100221|NCT02162121|Drug|Buprenorphine 0,2mg|
16100222|NCT02162121|Device|Stimulong, Pajunk, Germany.|
16100223|NCT02162121|Procedure|Continuous lumbar plexus: non-stimulating catheter|
16100224|NCT02162082|Device|stent or scaffold|implantation of a CE certified drug-eluting stent, bare-metal stent or scaffold
16100225|NCT02162069|Device|CE certified transcatheter ( aortic valve replacement)|Patients receive a transcatheter aortic valve replacement with CE certified transcatheter aortic valves.
16100226|NCT02162056|Device|use of bioresorbable vascular scaffolds|Implantation of bioresorbable vascular scaffolds for coronary artery disease.
16100227|NCT02162030|Behavioral|Acceptance and Commitment Therapy|Half of the participants will receive an eight-session ACT intervention whereby each component of the psychological flexibility model will be covered. Half of the participants will receive an eight-session act intervention whereby each component except self as context will be covered.
16100228|NCT02162017|Other|The lying flat (0°) head position for 24 hours|The patients should have strict bed rest for the first 24 hours after admission to hospital. They can be nursed in the side-lying position and feeding should be avoided or only given in the ≥30° position to reduce the risk of aspiration, and after a standard swallowing screening. Patients should have no more than 3 breaks of 30 minutes in a 30°head position in the first 24 hours, and none of the breaks are to be grouped together (i.e. no back-to back breaks are permitted).
16100229|NCT02162017|Other|The sitting-up (≥30°) head position for 24 hours|For sites that have been randomised to this position, the usual nursing care will be to have patients positioned to sitting-up with the head elevated at 30° or more by raising the head of the bed or use of extra pillows, whatever is the most appropriate, immediately upon presentation to the ED and to remain in that position for 24 hours. Patients should have no more than 3 breaks of 30 minutes in a lying flat head position in the first 24 hours, and none of the breaks are to be grouped together (i.e. no back-to back breaks are permitted).
16100230|NCT02162004|Procedure|Continuous Correction|
16100231|NCT02161991|Drug|Aprepitant|aprepitant should be give when patients receive platinum based chemotherapy, 125mg for day1, 80mg for day2 and day3.
16100232|NCT02161991|Drug|placebo|placebo should be give when patients receive platinum based chemotherapy, 125mg for day1, 80mg for day2 and day3.
16100233|NCT02161965|Drug|Rivaroxaban|20mg or 15mg
16100234|NCT02161965|Drug|Fluindione|
16100235|NCT02161965|Drug|Warfarin|
16100236|NCT02161952|Drug|Pirfenidone|Pirfenidone was supplied orally in 400 mg gel capsules three times daily (every 8 hours) for a full dosage of 1200 mg daily during 24 months.
16100237|NCT02161952|Drug|Matched equivalent placebo|
16100238|NCT02161939|Drug|Daclatasvir (BMS-790052)|
16100239|NCT02161939|Drug|Sofosbuvir|
16100240|NCT02161926|Other|dietary restrictions|Dietary restrictions during 8 weeks
16100241|NCT02161913|Behavioral|Multi-Family Group Treatment|
16100242|NCT02161913|Behavioral|SCI Education Control Group|
16100323|NCT02161263|Other|Patient Quality of Life andVision after LASIK Surgery|Patient questionnaire
16100414|NCT02160483|Other|Functional magnetic resonance imaging|3 Tesla magnetic resonance imaging
16100243|NCT02161900|Other|Yogic and routine exercises|All newly diagnosed cases with stage I-III of breast cancer who present to Tata Memorial Hospital will be randomly assigned to perform either a set of 'Yogic and Routine Exercises (referred to as exercise I) or Routine Exercises'(referred to as exercise II) . Patients will begin the exercises within a week of starting treatment.
16100244|NCT02161874|Device|T3 with DCD tapered Prevail implant|T3 with DCD implant with Certain (internal) connection and platform-switch design
16100245|NCT02161874|Device|Nanotite Certain tapered implant|Nanotite (DCD) implant with Certain (internal) connection and non- platform-switch design
16100246|NCT02161861|Other|cFFE increase the fusiogenic capacities of a gamete|
16100247|NCT02161848|Other|Magnetic Resonance Imaging|MRI of eye muscles, lower bag muscles, thigh muscles and calf muscles.
16100248|NCT02161835|Other|Training|30 minutes of home based pulse watch regulated cycle-ergometer exercise, three times a week at 75% of maximal oxygen consumption.
16100249|NCT02161822|Drug|simvastatin|simvastatin 80mg qd for 5weeks
16100250|NCT02161809|Behavioral|Healthy Eating and Physical Activity|The Healthy Eating and Physical Activity (HEPA) intervention aims to increase the quality of foods and beverages and physical activity opportunities in summer day camps. Through staff-level training, physical activity opportunities are modified to provide children with a substantial amount of meaningful physical activity. Through working with foods service providers, changes to the types of foods and beverages served will be made.
16100251|NCT02161796|Drug|FG-4592|Oral
16100252|NCT02161796|Drug|Placebo|Oral
16100253|NCT02161783|Drug|Fludarabine|Fludarabine 30 mg/m2 IV over 1 hour given on days -6 through -2 of transplant.
16100254|NCT02161783|Drug|Cyclophosphamide|Cyclophosphamide 14.5 mg/kg IV over 1-2 hours given on days -6 and -5 from transplant. And Cyclophosphamide 50 mg/kg IV over 2 hours given on days +3 and +4 from transplant.
16100255|NCT02161783|Radiation|Total Body Irradiation|TBI 200cGy in a single fraction on day -1 from transplant.
16100256|NCT02161783|Biological|Hematopoietic stem cell infusion|Hematopoietic stem cell infusion given on day 0.
16100257|NCT02161770|Drug|AZD9291 tablet dosing|Part A - single 80mg oral dose AZD9291 (administered as 1 80mg tablet). Part B - 80mg oral dose AZD9291 od.
16100258|NCT02161770|Procedure|Pharmacokinetic sampling - AZD9291|Blood sampling to measure AZD9291 pharmacokinetic parameters.
16100259|NCT02161770|Procedure|Pharmacokinetic sampling - AZ5140 and AZ7550|Blood samples to measure the pharmacokinetic parameters of AZ5104 and AZ7550.
16100260|NCT02161757|Biological|Tralokinumab|Subcutaneous injection
16100261|NCT02161757|Other|Placebo|Subcutaneous injection
16100262|NCT02161744|Biological|ADSCs administration|100- 240 cc of lipoaspirate will be extracted from the patient. The stromal vascular fraction (SVF) will be isolated with minimal manipulation. The cell pellet will be reconstituted in saline solution and administered intravenously to the patient.
16100263|NCT02161731|Drug|Evacetrapib|Oral administration
16100264|NCT02161731|Drug|Warfarin|Oral administration
16100265|NCT02161718|Drug|Samidorphan + olanzapine (ALKS 3831)|Oral tablet, taken once daily
16100266|NCT02161718|Drug|Placebo + olanzapine|Oral tablet, taken once daily
16100267|NCT02161705|Drug|Ropivacaine|0.5% ropivacaine (up to 0.8 mL/kg, equivalent to 4mg/kg) administered in paravertebral block
16100268|NCT02161705|Drug|Saline|Up to 0.8 mL/kg of normal saline administered
16100269|NCT02161692|Drug|Cyclophosphamide|
16100270|NCT02161692|Drug|Etoposide|
16100271|NCT02161692|Drug|Cisplatin|
16100272|NCT02161692|Drug|Bleomycin|
16100273|NCT02161692|Drug|Carboplatin|High dose carboplatin
16100274|NCT02161679|Drug|IMMU-132 infusion is administered to participants in one arm for the study|
16100275|NCT02161679|Drug|IMMU-132 plus Carboplatin infusion|
16100276|NCT02161653|Drug|Prednisone plus Metadoxine|
16100277|NCT02161653|Drug|Pentoxifylline plus Metadoxine|
16100278|NCT02161627|Device|Saluda Medical External Trial System|
16100279|NCT02161627|Device|Saluda Medical External Trial System|
16100280|NCT02161614|Drug|Estradiol valerate|
16100281|NCT02161614|Drug|Placebo|
16100282|NCT02161601|Procedure|Cricoid Pressure|Correct Cricoid pressure applied against the cricoid cartilage, Incorrect Cricoid pressure applied against the thyroid cartilage and trachea
16100283|NCT02161588|Drug|semaglutide|Once-daily oral administration as tablets. The dose level of oral semaglutide used in the 'Dose escalation period', 'Treatment period 1', 'Treatment period 2' and 'Treatment period 3' will be 5, 10, 20 and 40 mg per day, respectively.
16100284|NCT02161588|Drug|placebo|Once-daily oral administration as tablets.
16100285|NCT02161575|Drug|Ranibizumab|Intraveal injections of 0.5mg ranibizumab
16100286|NCT02161562|Drug|omalizumab|150mg omalizumab via sub-cutaneous injection once every 4 weeks
16100287|NCT02161562|Drug|omalizumab|300mg omalizumab via sub-cutaneous injection once every 4 weeks
16100288|NCT02161549|Device|Motus Gl CleanUp System|
16100289|NCT02161536|Device|Motus Cleansing System|
16100290|NCT02161510|Drug|MK-2248|MK-2248 in once-daily oral doses of 200-≤800 mg for 7 days
16100291|NCT02161484|Procedure|Continuous Lumbar Plexus Block|Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm. In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.
16100292|NCT02161484|Procedure|Parasacral Nerve Block|A single shot parasacral (sciatic) nerve block will then be place under the ultrasound guidance. Ropivacaine 0.2% 9 ml will be injected.
16100293|NCT02161484|Drug|Ropivacine 0.2%|Lumbar plexus nerve block placement and activation: After subcutaneous infiltration of local anesthetic, 20 mL of Ropivacaine 0.2% will be injected; the catheter will be introduced for 5 cm past the needle tip and secured with steri strips and tegaderm.
16100294|NCT02161484|Drug|Bupivacaine 0.0625%|In PACU, the catheter will be connected to a pump of 0.0625% bupivacaine at 5 - 10 mL per hour at the discretion of the Acute Interventional Perioperative Pain Service (AIPPS). Additional 5mL boluses of 0.0625% bupivacaine will be given on demand once per hour prn.
16100295|NCT02161458|Drug|Escitalopram 20mg for 2 weeks|30 cognitively normal adults aged 60-85 will receive escitalopram 20 mg for 2 weeks; amyloid beta levels in the CSF will be measured at baseline (before drug administration) and following the full study drug (i.e., active drug) administration.
16100296|NCT02161458|Drug|Escitalopram 20mg for 8 weeks|30 cognitively normal adults aged 60-85 will receive escitalopram 20 mg for 8 weeks; amyloid beta levels in the CSF will be measured at baseline (before drug administration) and following the full study drug (i.e., active drug) administration.
16100297|NCT02161458|Drug|Escitalopram 30mg for 8 weeks|30 cognitively normal adults aged 60-85 will receive escitalopram 30 mg for 8 weeks; amyloid beta levels in the CSF will be measured at baseline (before drug administration) and following the full study drug (i.e., active drug) administration.
16100298|NCT02161458|Drug|Placebo|Additionally, 30 cognitively normal adults aged 60-85 will receive a placebo; amyloid beta levels in the CSF will be measured at baseline (before drug administration) and following the full study drug (i.e., placebo) administration.
16100299|NCT02161445|Device|the acoustic cardiographic parameters were calculated|STIs were measured using simultaneous recording of the electrocardiogram and acoustic cardiography signals using an analogic numeric system (Biopac Systems, Goleta, CA). A3-minute acoustic cardiographic tracing for all patients was obtained and stored electronically. We measured the electromechanical activation time (EMAT) which is the time between the initial deflection of the electrocardiographic Q wave and the first phonocardiographic complex corresponding to the first heart sound (S1). The left ventricle ejection time (LVET) defined as the interval between the peak components from the S1 and S2 complexes was measured on the same cardiac cycles. All studies were performed in patients in a semi-recumbent position with head at 30 degrees position. For each patient, the acoustic cardiographic parameters were calculated from a 10-second free of artifact recording of data averaging 8 to 12 beats measurements.
16100300|NCT02161432|Drug|BI 187004|single dose BI 187004 given as tablet in fed state
16100301|NCT02161432|Drug|BI 187004|single dose BI 187004 given as tablet in fasted state
16100302|NCT02161432|Drug|BI 187004|single dose BI 187004 given as oral solution
16100303|NCT02161419|Drug|Roniciclib (BAY1000394)|Patients will receive roniciclib treatment as a 3 days on / 4 days schedule off with two 2.5 mg tablets twice daily for a total dose of 10.0 mg/day during 6 cycles (21 days each) of chemotherapy with Carboplatin/etoposide or Cisplatin/etoposide and continue thereafter as monotherapy until tumor progression, unacceptable toxicity, death, consent withdrawal, or withdrawal from the study.
16100304|NCT02161419|Drug|Placebo|Patients will receive placebo treatment as a 3 days on / 4 days schedule off with two tablets twice daily during 6 cycles (21 days each) of chemotherapy with Carboplatin/etoposide or Cisplatin/etoposide and continue thereafter as monotherapy until tumor progression, unacceptable toxicity, death, consent withdrawal, or withdrawal from the study
16100305|NCT02161406|Drug|Abatacept|Subjects will be treated with injections of 125 mg of abatacept or placebo weekly for 52 weeks
16100306|NCT02161406|Drug|Placebo|125 mg of Placebo
16100307|NCT02161393|Behavioral|Physical Activity Intervention|The 12 week home-based pedometer-driven walking programme will consist of weekly physical activity consultations. Pedometers will be used to set weekly step goals and motivate patients. Patients will wear the pedometer for 7 days and will record their daily steps in a step diary. At the next appointment the step target for the subsequent week will be agreed between the physiotherapist/researcher and participant. Each week thereafter the physiotherapist/researcher and patient will discuss their progress, document their mean daily step count for the previous week, and agree to a new daily step target for the subsequent week. The walking programme will be tailored to the individual and progressed on a weekly basis.
16100308|NCT02161393|Behavioral|Pulmonary Rehabilitation Programme|This will be a 6-week supervised outpatient programme. The exercise component will last for one hour and be delivered twice weekly. It will consist of cardiovascular exercises and lower and upper body strengthening exercises. Education sessions will be delivered once weekly. Each patient will be provided with a home exercise programme to complete unsupervised once weekly.
16100309|NCT02161380|Drug|injection of scAAV2-P1ND4v2 1.18x10e9 vg (Low),|injection of Total Volume of each intravitreal injection is 200 µL
16100310|NCT02161380|Drug|injection of scAAV2-P1ND4v2 5.81 X10e9 vg (Med)|injection of Total Volume of each intravitreal injection is 200 µL
16100311|NCT02161380|Drug|injection of scAAV2-P1ND4v2 2.4 X10e10vg (High)|injection of Total Volume of each intravitreal injection is 100 µL
16100312|NCT02161380|Drug|injection of scAAV2-P1ND4v2 1.0 X10e11vg (Higher)|injection of Total Volume of each intravitreal injection is 100 µL
16100313|NCT02161367|Drug|Simethicone|"Pharmacological category: antiflatulent
~160mg Simethicone orally, 4 times a day for the first five postoperative days"
16100314|NCT02161367|Drug|Oral Suspending Vehicle|"ORA-Plus is an aqueous-based vehicle.
~Identical to the test drug formulation except for being pharmacologically inert. 160mg Ora-Plus orally, 4 times a day for the first five postoperative days"
16100315|NCT02161354|Drug|NTC-510 capsules|Subjects will be randomized to one of 3 groups and NTC-510 will be given as a single oral dose of 2.0 mg, a split dose of 2.0 mg followed by 2.0 mg an hour later, or 6.0 mg for acute pain relief (PR) following third molar extraction.
16100316|NCT02161354|Drug|Placebo Capsules|Subjects will be randomized to one of 3 groups and placebo capsules will be given as a single oral dose of for acute dental pain following third molar extraction.
16100317|NCT02161354|Drug|NTC-510A Capsules|Subjects will be randomized to one of 3 groups where NTC-510A or placebo will be given as a single oral dose of 2.0, 4.0, or 6 mg for acute pain relief (PR) following third molar extraction
16100318|NCT02161328|Other|EIT belt|
16100319|NCT02161302|Device|transcranial direct current stimulation (tDCS)|The stimulation will be administered with a pair of surface electrodes, sponge coated, soaked in saline. A battery-powered constant current stimulator will be used for this purpose (tDCS device Soterix 1X1). The stimulation is performed by placing the anodal electrode in the primary motor cortex (M1) and the cathodal one in the contralateral supraorbital area and it will use a 2 mA current.
16100320|NCT02161302|Device|Sham Transcranial Direct Current Stimulation|The sham tDCS consists of the same montage of the active tDCS, but the device is turned off 30 seconds after initiating stimulation (without letting the patient notice it). Rest of the montage is kept identical as the active one during the 20 minutes that the session lasts.
16100321|NCT02161276|Drug|TNTL capsule|Patients were asked to taken drugs 3 times a day, with each time 3 grains
16100324|NCT02161250|Dietary Supplement|Resistant Starch|Each subject will complete 2 testing days (randomized and crossover design). On each of 2 test days, subjects will arrive at the Purdue Clinical Research Center after a 12-h fast and will consume a beverage containing resistant starch. The test beverage will be consumed along with a standard meal provided at the start of the test day. A second standard meal that does not contain the beverage will be consumed four hours later. Below is what will be included in the test bar.
16100325|NCT02161250|Dietary Supplement|Control|Each subject will complete 2 testing days (randomized and crossover design). On each of 2 test days, subjects will arrive at the Purdue Clinical Research Center after a 12-h fast and will consume a beverage containing maltodextrin. The test beverage will be consumed along with a standard meal provided at the start of the test day. A second standard meal that does not contain the beverage will be consumed four hours later. Below is what will be included in the test bar.
16100326|NCT02161237|Drug|Advagraf®|oral
16100327|NCT02161224|Drug|FG-4592|Oral
16100328|NCT02161211|Behavioral|De-coupling|Six sessions of CBT for anxiety-alcohol de-coupling
16100329|NCT02161211|Behavioral|Anxiety Reduction|Six sessions of CBT for anxiety reduction.
16100330|NCT02161211|Behavioral|Combined|Three sessions devoted to anxiety reduction and to anxiety-alcohol de-coupling each.
16100331|NCT02161198|Dietary Supplement|Y-75|Y-75 (1 g) and starch (1 g) as a diluting agent and were packed to contain 2 g/package
16100332|NCT02161198|Dietary Supplement|Placebo|Caramel syrup (0.03 g) and starch (1.97 g) were packed identically to the active treatment
16100333|NCT02161185|Drug|USL261|5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol
16100334|NCT02161159|Biological|botulinum toxin Type A|botulinum toxin Type A administered in accordance with physician standard practice.
16100335|NCT02161146|Drug|AGN-229666|One drop of AGN-229666 in the eye on Days 1 and 15.
16100336|NCT02161146|Drug|Vehicle to AGN-229666|One drop of Vehicle to AGN-229666 in the eye on Days 1 and 15.
16100337|NCT02161146|Drug|Olopatadine|One drop of olopatadine in the eye on Days 1 and 15.
16100338|NCT02161133|Behavioral|Problem-Solving Therapy|Problem-Solving Therapy is a treatment approach that teaches patients strategies to address real-life problems.
16100339|NCT02161133|Behavioral|Health Education|Health Education provides didactic information about Gulf War Illness
16100340|NCT02161120|Other|Traditional Finnish rye bread|
16100341|NCT02161120|Other|Low FODMAP rye bread|
16100342|NCT02161107|Biological|Grass-SPIRE|Intradermal injection
16100343|NCT02161107|Biological|Placebo|Intradermal injection
16100344|NCT02161094|Behavioral|Give incentives to physicians based on their patient's HbA1c improvement|
16100345|NCT02161094|Behavioral|Give incentives to patients based on their own HbA1c improvement|
16100346|NCT02161081|Procedure|Myocardial CT perfusion|Adenosine-stress dynamic myocardial CT perfusion using 128-slice dual-source CT
16100347|NCT02161055|Drug|Insulin|"Insulin dose was selected in accordance with the Yale Insulin Infusion Protocol.
~• Amount of insulin (u) = [fasting blood glucose (mmol/L) × 18-100] × 10 × body weight (kilogram) × 0.6 ÷ 1000 ÷ 2"
16100348|NCT02161029|Device|Flexible drill biopsy instrument|Biopsies taken with the new drill biopsy instrument for flexible endoscopy
16100349|NCT02161029|Device|conventional biopsy instrument|Biopsies taken with conventional biopsy forceps for flexible endoscopic instruments
16100350|NCT02161016|Device|map3|Patients will receive map3® Cellular Allogeneic Bone Graft containing donor matched stem cells.
16100351|NCT02161003|Procedure|Stem Cells Injection Technique|Injection of MSCs for the treatment of anal sphincter insufficiency is a potential alternative therapy for imperforate anus patients who have undergone primary PSARP with post-operative FI. In this study a single dose of 1.2 ml MSC will be divided into 12 part of 0.1ml of MSC, doses will be injected into the anal sphincter all around in 12 injection sites according to the clock meridian under general anesthesia without giving muscle relaxant.
16100352|NCT02161003|Procedure|Stem Cell Isolation|From the upper posterior iliac crest 10 ml bone marrow sample will be extracted from patients using a heparinized syringe, under general anesthesia, in a suitable clean operation room.
16100353|NCT02160990|Drug|Exenatide|5 mcg exenatide subcutaneously twice daily for 30 days
16100354|NCT02160990|Drug|Placebo|placebo subcutaneously twice daily for 30 days
16100355|NCT02160977|Procedure|total knee arthroplasty|
16100356|NCT02160951|Drug|LGH447|LGH447, QD
16100357|NCT02160938|Other|3-year follow-up|"When the infants reach 24 months of age, the Study Follow-up Specialist will send all participants an age- appropriate Ages and Stages Questionnaire (ASQ) for completion.
~At the age of 3, the following exams will be performed and are described below:
~The Vineland-II Adaptive Behavior Scale (VABS)
~Wechsler Preschool and Primary Scale of Intelligence IV (WPPSI-IV), or Wechsler Intelligence Scale for Children - Fifth Edition (WISC-V, for siblings older than 7 years 7 months, when necessary)
~Children will also be photographed (for review by the study dysmorphologist)"
16100358|NCT02160925|Other|Preoperative 99mTc-Sestamibi SPECT/CT|
16100359|NCT02160899|Drug|ISIS-APO(a)Rx|ISIS-APO(a)Rx subcutaneously: 100 mg on Days 1, 8, 15, and 22; 200 mg on Days 29, 36, 43, and 50 unless down-titrated; and 300 mg on Days 57, 64, 71, and 78 unless down-titrated.
16100360|NCT02160899|Drug|Placebo|Normal saline as Placebo, subcutaneously on Days 1, 8, 15, 22, 29, 36, 43, 50, 57, 64, 71, and 78.
16100361|NCT02160886|Behavioral|child-goal|"The 8-week goal-directed intervention include completing a daily home program and a weekly follow-up session with the child's occupational therapist.
~The parents are responsible for the day to day practice and are encouraged to let the children practice daily in their natural environment.
~The home-programs focus on enhancing the agreed upon goal specific task performance. They include structured practice of tasks and adaptations and modifications of the environment and the tasks.
~The weekly sessions with the occupational therapist are meant to sustain motivation, follow-up on progress, adjust the home program for the coming week and support parents in how to carry out the daily interventions."
16100409|NCT02160522|Device|Cuffed ETT|Measurement of the cuff pressure on an endotracheal tube and lower pressure to a safe range if it is elevated.
16100410|NCT02160509|Device|IPhone based realtime remote ultrasound interpretation|
16100411|NCT02160496|Behavioral|Weight loss interventional study with 20% protein-diet|
16100412|NCT02160496|Behavioral|Weight loss interventional study with 27% protein-diet|
16100362|NCT02160886|Behavioral|parent-goal|"The 8-week goal-directed intervention include completing a daily home program and a weekly follow-up session with the child's occupational therapist.
~The parents are responsible for the day to day practice and are encouraged to let the children practice daily in their natural environment.
~The home-programs focus on enhancing the agreed upon goal specific task performance. They include structured practice of tasks and adaptations and modifications of the environment and the tasks. .
~The weekly sessions with the occupational therapist are meant to sustain motivation, follow-up on progress, adjust the home program for the coming week and support parents in how to carry out the daily interventions."
16100363|NCT02160873|Other|chocolate milk|12 oz, 7-8 hours prior to exercise trial (night before)
16100364|NCT02160873|Other|flavor-matched placebo|12 oz, non-caloric flavor-matched placebo
16100365|NCT02160847|Behavioral|DRIVE Program|The DRIVE program (Developing Relationships that Include Values of Eating and Exercise) is a home-based parent training program, which involves 15 sessions focusing on parent-child interactions, health and nutrition, and physical activity
16100366|NCT02160834|Behavioral|B-MOBILE Smartphone-Based Intervention (3-min break)|"Participants will receive a smartphone with B-MOBILE app that automatically monitors their sedentary time and prompts them after every 30 continuous sedentary minutes to walk for at least 3 minutes. Participants who meet this goal will receive reinforcing feedback in real time."
16100367|NCT02160834|Behavioral|B-MOBILE Smartphone-Based Intervention (6-min break)|"Participants will receive a smartphone with B-MOBILE app that automatically monitors their sedentary time and prompts them after every 60 continuous sedentary minutes to walk for at least 6 minutes. Participants who meet this goal will receive reinforcing feedback in real time."
16100368|NCT02160821|Procedure|Caudal Epidural|Ultrasound Guided Caudal Block
16100369|NCT02160821|Procedure|Transversus Abdominis Plane Block|Ultrasound Guided Transversus Abdominis Plane Block
16100370|NCT02160808|Drug|Secretin|Drug to stimulate pancreatic secretion
16100371|NCT02160808|Drug|Placebo|
16100372|NCT02160782|Drug|LUM001 (Maralixibat)|LUM001, also known as Maralixibat (MRX) will be administered orally Once Daily (OD). To be administered Twice Daily (BID) for patients who are eligible.
16100373|NCT02160782|Drug|Placebo|Placebo will be administered orally once daily during randomized withdrawal period
16100374|NCT02160756|Drug|JNJ-56021927 Softgel Capsule|Single oral dose of JNJ-56021927 240 mg softgel capsule on Day 1.
16100375|NCT02160756|Drug|JNJ-56021927 Tablet Formulation 1|Single oral dose of JNJ-56021927 240 mg Tablet Formulation 1 on Day 1.
16100376|NCT02160756|Drug|JNJ-56021927 Tablet Formulation 2|Single oral dose of JNJ-56021927 240 mg Tablet Formulation 2 on Day 1.
16100377|NCT02160756|Drug|JNJ-56021927 Tablet Formulation 3|Single oral dose of JNJ-56021927 240 mg Tablet Formulation 3 on Day 1.
16100378|NCT02160743|Dietary Supplement|CJ-30056 20/500mg (atorvastatin/metformin XR 20/500mg)|
16100380|NCT02160704|Drug|Enclomiphene citrate|25 mg daily for 16 weeks
16100381|NCT02160704|Other|Placebo|placebo daily for 16 weeks
16100383|NCT02160678|Drug|Vehicle|Cream Vehicle (placebo) (G & W Laboratories, Inc.)- vehicle
16100384|NCT02160678|Drug|Tazarotene Cream, 0.1 %|Tazarotene Cream, 0.1 % (G & W Laboratories, Inc.) - test product
16100385|NCT02160678|Drug|Tazorac Cream, 0.1%|Tazorac Cream, 0.1% (Allergan, Inc.) - reference product
16100386|NCT02160665|Drug|Tazarotene Cream, 0.05%|Tazarotene Cream, 0.05% (G & W Laboratories, Inc.)
16100387|NCT02160665|Drug|Vehicle|Vehicle of Test product (G & W Laboratories, Inc.)
16100388|NCT02160665|Drug|Reference: Tazorac Cream, 0.05%|Reference: Tazorac (tazarotene) Cream, 0.05% (Allergan, Inc.)
16100389|NCT02160652|Procedure|Laparoscopic ureteral re-implantation.|Laparoscopic ureteral re-implantation for the treatment of malignant ureteral obstruction.
16100390|NCT02160639|Other|diabetes self management support|diabetes self management support is telephonic and provided by health investigators
16100391|NCT02160626|Drug|A-101 Vehicle|Placebo control
16100392|NCT02160626|Drug|A-101 (40) Topical Solution|A-101 (40) Topical Solution - high dose
16100393|NCT02160626|Drug|A-101 (32.5) Topical Solution|A-101 (32.5) Topical Solution - low dose
16100394|NCT02160613|Procedure|Open flap debridement|an access flap
16100395|NCT02160600|Other|Standard multiphase CT|
16100396|NCT02160600|Other|split bolus Dual energy CT|
16100397|NCT02160587|Drug|Chloraprep|ChloraPrep will be compared to ZuraPrep with regard to skin sensitization and irritation.
16100398|NCT02160587|Drug|0.9% Physiological Saline|0.9% Physiological Saline will be compared to ZuraPrep with regard to skin sensitization and irritation.
16100399|NCT02160587|Other|ZuraPrep without IPA|ZuraPrep without IPA will be compared to ZuraPrep with regard to skin sensitization and irritation
16100400|NCT02160574|Drug|ChloraPrep|The degree of skin irritation caused by ChloraPrep will be graded and compared to ZuraPrep and ZuraPrep without IPA.
16100401|NCT02160574|Drug|0.1% Sodium Lauryl Sulfate|The degree of skin irritation caused by 0.1% Sodium Lauryl Sulfate will be graded and compared to ZuraPrep and ZuraPrep without IPA.
16100402|NCT02160574|Drug|0.9% Physiological Saline|The degree of skin irritation caused by 0.9% Physiological Saline will be graded and compared to ZuraPrep and ZuraPrep without IPA.
16100403|NCT02160574|Other|ZuraPrep without IPA|Results from exposure to ZuraPrep will be compared statistically those from exposure to ZuraPrep without IPA
16100404|NCT02160561|Other|Intervention Arm|Placing patients who are in critical illness with acute respiratory failure and are mechanically ventilated in an upright reverse trendelenburg position
16100405|NCT02160548|Drug|Standard care|Standard management for OP poisoning
16100406|NCT02160548|Drug|Standard care+ 2.5 mg Salbutamol|Ventolin respiratory solution 2.5 mg
16100407|NCT02160548|Drug|Standard care+ 5 mg Salbutamol|Ventolin respiratory solution 5 mg
16100408|NCT02160535|Drug|OnabotulinumtoxinA|155 units of OnabotulinumtoxinA administered intramuscularly. Injections are divided across seven injection specific head/neck muscle areas every 12 weeks to prevent chronic migraine post traumatic headache
16100413|NCT02160496|Behavioral|Weight loss interventional study with 35% protein-diet|
16100415|NCT02160470|Behavioral|Exposure Therapy with Retrieval|Participants will receive one-session exposure therapy (up to 92 minutes) for fear of spiders or fear of snakes. Thirty minutes prior to exposure therapy, participants will receive a fear retrieval trial, which is a brief exposure to the feared stimulus (snake or spider). Based on recent basic science research, the fear retrieval trial is expected to enhance the efficacy of exposure therapy.
16100416|NCT02160470|Behavioral|Exposure Therapy with Compound Extinction|Participants will receive one-session exposure therapy (up to 92 minutes) for fear of spiders or fear of snakes. As a component of therapy, participants will receive compound extinction, which consists of exposure to two feared stimuli simultaneously (two spiders or two snakes). Based on recent basic science research, compound extinction is expected to enhance the efficacy of exposure therapy.
16100417|NCT02160470|Behavioral|Exposure Therapy with Retrieval and Compound Extinction|Participants will receive one-session exposure therapy (up to 92 minutes) for fear of spiders or fear of snakes. Thirty minutes prior to exposure therapy, participants will receive a brief fear retrieval trial. As a component of therapy, participants will also receive compound extinction.
16100418|NCT02160470|Behavioral|Therapist-guided Exposure Therapy|Participants will receive one-session exposure therapy (up to 92 minutes) for fear of spiders or fear of snakes.
16100419|NCT02160457|Other|Intervention with IGA|"Individually tailored interdisciplinary intervention based on measures performed as part of the Cerebral Palsy follow-Up Program and other clinical examinations AND instrumented gait analysis
~The instrumented gait analysis consists of four steps:
~Instrumented gait analysis (data collection with a 8-camera Vicon T40 system (Vicon, Oxford, UK) and 2 force plates (AMTI, OR6-7-1000)
~Impairment-Focused Interpretation
~Recommendation for interdisciplinary interventions
~Dissemination of recommendations
~The two modalities differs in the use of IGA, but the study is not indented to document the effect of IGA alone, but to document the difference in the effects of the interdisciplinary interventions, when IGA is implemented to the experimental group."
16100420|NCT02160444|Behavioral|CBT plus Parent as CBT Coach Training|Standard CBT for treatment of anxiety disorders in youth is completed by the children while their primary caregiver receives training in the same cognitive behavioral skills, how to recognize when he or she is accommodating his or her child's anxiety, and how to create and implement exposure activities.
16100421|NCT02160431|Behavioral|CBT for pediatric OCD|Participants complete standard CBT for OCD as delivered in the POTS study .
16100422|NCT02160418|Behavioral|Financial Incentives|
16100423|NCT02160418|Behavioral|Cognitive Incentives|
16100424|NCT02160418|Behavioral|Financial and Cognitive Incentives|
16100425|NCT02160405|Dietary Supplement|native potato|
16100426|NCT02160392|Procedure|Endometrial biopsy|Endometrial biopsy (EMB) specimens were collected via a 3 mm diameter plastic pipelle that was inserted into the uterus following EML. A sample of tissue was obtained by retracting the pipelle's plunger leading to negative suction and rotating the cannula for approximately 15 seconds.
16100427|NCT02160379|Other|standard test meal|
16100428|NCT02160366|Other|Biomarker Research|Research studies on new biomarkers conducted on previously banked blood and/or tumor tissue. Samples collected may include blood, fresh tumor tissue, urine, saliva, bone marrow, pleural fluid, ascites, skin or hair follicle.
16100429|NCT02160353|Drug|Abiraterone acetate, Prednisolone|
16100430|NCT02160314|Device|pessary|disposable, single-use pessary
16100431|NCT02160314|Device|Absorbent pad|
16100432|NCT02160301|Drug|Gabapentin|PO
16100433|NCT02160301|Drug|Acetaminophen|PO
16100434|NCT02160301|Drug|Acetaminophen|IV
16100435|NCT02160301|Drug|Celecoxib|PO
16100436|NCT02160301|Drug|Dexamethasone|IV
16100437|NCT02160301|Drug|Oxycodone|PO
16100438|NCT02160288|Drug|Botulinum Toxin-A|100 Units diluted in a 5 cc syringe at a concentration of 20U/mL
16100439|NCT02160288|Drug|Normal Saline|Dispensed in a 5 cc syringe
16100440|NCT02160275|Device|Artificial Pancreas (Inreda Diabetic BV)|Bi-hormonal reactive closed loop system without mealtime announcement, miniaturized prototype
16100441|NCT02160275|Device|Insulin pump therapy|Patients' own insulin pump with fast-acting insulin analog
16100442|NCT02160262|Drug|Dasotraline|Dasotraline 4 mg, 6 mg, 8 mg, flexibly dosed, once daily
16100443|NCT02160249|Behavioral|Community-based rehabilitation|
16100444|NCT02160249|Other|Facility based care|
16100445|NCT02160236|Drug|dexketoprofen trometamol|before end of the surgery via intravenous administration 50 mg dexketoprofen trometamol in 0.9 % NaCl 100 cc
16100446|NCT02160236|Drug|tenoxicam|before the end of the surgery via administration intravenous 20 mg tenoxicam in 0.9% NaCl in 100 cc
16100447|NCT02160236|Drug|serum physiologic|before end of the surgery via administration intravenous 0.9 % NaCl 100 cc
16100448|NCT02160223|Drug|Sugammadex|Group S patients will receive 2 mg kg -1 sugammadex at he end of surgery
16100449|NCT02160223|Drug|Neostigmine|Patient in Gropu N will receive 50 µg kg-1 neostigmin and 05 mg atropin at the end of surgery
16100450|NCT02160210|Device|Ultrafine Endoscope|Ultrafine endoscope reaching to the cecum within 15mins is thought to be successful.Water colonoscopy with standard colonoscope will be performed in unsuccessful subjects subsequently.
16100451|NCT02160197|Device|Aircast XP Walker boot|Ankle boot allowing weight bearing as tolerated
16100452|NCT02160197|Device|Plaster Immobilisation|Plaster immobilisation with no weight bearing allowed.
16100453|NCT02160184|Device|Artificial pancreas system consisting of a predictive rule-based algorithm integrated on the Medtronic Portable Glucose Control System (PGCS)|
16100454|NCT02160171|Device|Algorithm for Neonatal Seizure Recognition|Software system for neonatal seizure detection recognition
16100455|NCT02160158|Drug|Fesoterodine ER (fasted)|Commercial Fesoterodine ER 4 mg (single dose)
16100456|NCT02160158|Drug|Fesoterodine SR3 (fasted)|Fesoterodine SR3 4 mg (single dose)
16100457|NCT02160158|Drug|Fesoterodine SR3 (fed)|Fesoterodine SR3 4 mg (single dose) with high-fat meal
16100458|NCT02160158|Drug|Fesoterodine ER (fed)|Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal
16100459|NCT02160158|Drug|Fesoterodine SR3 (sprinkle)|Fesoterodine SR3 4 mg (single dose) beads sprinkled on applesauce
16100460|NCT02160158|Drug|Fesoterodine ER (fasted)|Commercial Fesoterodine ER 4 mg (single dose)
16100461|NCT02160158|Drug|Fesoterodine SR4 (fasted)|Fesoterodine SR4 4 mg (single dose)
16100462|NCT02160158|Drug|Fesoterodine SR4 (fed)|Fesoterodine SR4 4 mg (single dose) with high-fat/high calorie meal
16100463|NCT02160158|Drug|Fesoterodine ER (fed)|Commercial Fesoterodine ER 4 mg (single dose) with high-fat meal
16100464|NCT02160158|Drug|Fesoterodine SR4 (sprinkle)|Fesoterodine SR4 4 mg (single dose) beads sprinkled on applesauce
16100465|NCT02160145|Drug|Tolvaptan (OPC-41061)|Tolvaptan tablets (15 or 30 mg) will be self-administered orally as split-dose regimens, once upon awakening and another approximately 8 to 9 hours later.
16100466|NCT02160145|Drug|Placebo|Matching placebo tablets will be self-administered orally as split-dose regimens, once upon awakening and another approximately 8 to 9 hours later
16100467|NCT02160132|Drug|Methylprednisolone(intravenously in the 1st-2nd-3rd month )|Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-2nd-3rd month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months.
16100468|NCT02160132|Drug|Methylprednisolone(intravenously in the 1st-3rd-5th month)|Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-3rd-5th month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months.
16100469|NCT02160119|Other|MRI-based techniques|fMRI, DTI
16100470|NCT02160119|Other|EEG|ERP
16100471|NCT02160106|Drug|TEW-7197|Single daily doses by oral administration on Days 1, 2, 3, 4, 5, Days 8, 9, 10, 11, 12, Days 15, 16, 17, 18, 19 and Days 22, 23, 24, 25, 26 of each 28 day cycle. Starting dose is 30 mg, with escalation to 60 mg, and subsequent dose escalation using a modified Fibonacci algorithm.
16100472|NCT02160080|Drug|Boceprevir 800mg/TID+Pegylated interferon alfa+Ribavirin|Boceprevir 800mg/TID+Pegylated interferon alfa+Ribavirin
16100473|NCT02160067|Drug|Second generation BTDS patch|
16100474|NCT02160067|Drug|First generation BuTrans patch|
16100475|NCT02160054|Drug|Graceptor®|oral
16100476|NCT02160041|Drug|BGJ398|BGJ398 was dosed on a flat scale of 125 mg (e.g., 1 x 100 mg and 1 x 25 mg capsules) once daily for the first 21 days of the 28-day cycle (3 weeks on, 1 week off in a cycle). A complete treatment cycle is defined as 28 days.
16100477|NCT02160028|Other|anesthetics and extended information before dental treatment|The extended information is a comprehensive explanation about what to expect of the treatment and the anesthetic method, phrased in positive words and opening up for questions after information is given.
16100478|NCT02160028|Other|anesthetics and standard information before dental treatment|The standard information is short and concise, telling in neutral words what to expect.
16100479|NCT02160015|Drug|Ibrutinib|Given PO
16100480|NCT02160015|Other|Laboratory Biomarker Analysis|Correlative studies
16100481|NCT02160015|Drug|Lenalidomide|Given PO
16100482|NCT02160015|Biological|Rituximab|Given IV
16100483|NCT02160002|Procedure|Weaning from an incubator at a lower weight (1600 grams)|Infants will be weaned from an incubator at a lower weight (1600 grams)
16100484|NCT02160002|Procedure|Weaning from an incubator at a higher weight (1800 grams)|Infants will be weaned from an incubator at a higher weight (1800 grams)
16100485|NCT02159989|Drug|Sapanisertib|Given PO
16100486|NCT02159989|Biological|Ziv-Aflibercept|Given IV
16100487|NCT02159976|Drug|Pantoprazole|Pantoprazole 40mg bid
16100488|NCT02159976|Drug|Amoxicillin|Amoxicillin 1000mg bid
16100489|NCT02159976|Drug|Clarithromycin|Clarithromycin 500mg bid
16100490|NCT02159976|Drug|Metronidazole|Metronidazole 500mg tid
16100491|NCT02159976|Drug|Tetracycline|Tetracycline 1000mg bid
16100492|NCT02159976|Drug|Bismuth|Bismuth 600mg bid
16100493|NCT02159963|Other|Supervised training|8 weeks high intensity interval training, 3 times a week, one is supervised, two are home based unsupervised.
16100494|NCT02159963|Other|Unsupervised training|8 weeks home based high-intensity-interval cycle-training 3 times a week.
16100495|NCT02159963|Other|Optional training|8 weeks of optional home based, unsupervised training.
16100496|NCT02159963|Other|Control|8 weeks of control period. Participants are doing daily living.
16100497|NCT02159950|Other|Laboratory Biomarker Analysis|Correlative studies
16100498|NCT02159950|Biological|Sipuleucel-T|Given IV
16100499|NCT02159950|Drug|Tasquinimod|Given PO
16100500|NCT02159937|Other|Blood sampling by vena punction.|In vitro tests will be performed after blood sample collection from metastatic cancer patients
16100501|NCT02159911|Drug|Misoprostol administered orally one hour before surgery|"Closed and numbered envelopes, containing a capsule with either 200mcg or 400mcg of misoprostol were randomly distributed to the patients. Each envelope was coded randomly and only the pharmaceutical department of the hospital knew the content of these envelopes and kept a list of their codes.
~The misoprostol was administered by the floor nurse, per-os to the patient one hour before hysteroscopy with a small amount of water. The number on the envelope was noted by the nurse on the document relative to the patient. Hence, the patient, the physician performing the biopsy, the nurse and the research associate did not know the exact dose of misoprostol that was ingested by the patient."
16100502|NCT02159898|Device|EndoMAXX Endoluminal Valve Technology (EVT)|
16100503|NCT02159898|Device|EndoMAXX|
16100504|NCT02159885|Other|Telemonitoring|
16100505|NCT02159872|Drug|Omacetaxine|1.25 mg/m2 subcutaneously every 12 hours on Days 1-3 of every 28-day study cycle.
16100506|NCT02159859|Drug|Ertapenem|Subjects are hemodialysis patients who are admitted to Oakwood Hospital - Dearborn
16100507|NCT02159833|Other|Intranasal challenge with active substance (food protein)|
16100508|NCT02159833|Other|Intranasal challenge with placebo|
16100509|NCT02159820|Drug|Decitabine (DTC Arm)|Patients in DTC arm will receive lower-dose decitabine (7 mg/m2) administered intravenously within 1 hour for a consecutive 5 days, followed by TC regimen on day 6.
16100510|NCT02159820|Drug|Paclitaxel and Carboplatin (TC Arm)|The TC arm consisted of paclitaxel 150 mg/m2 administered intravenously (IV) over 3 hours followed by carboplatin (area under the curve [AUC] 5) administered by IV over 30 to 60 minutes both on day 1 of a 3-week schedule. Dose reductions were allowed depending on hematologic or nonhematologic toxicity, as follows: carboplatin AUC4; paclitaxel 135 mg/m2. Patients who achieved partial remission after six cycles could receive additional cycles on their physicians' discretion.
16100511|NCT02159807|Drug|Bupivacaine|The dose of bupivacaine administered intrathecally during placement of the spinal anesthetic.
16100512|NCT02159807|Drug|Fentanyl|20 micrograms routinely administered in combination in the spinal anesthetic
16100513|NCT02159794|Device|HLT Transcatheter Aortic Valve System|Transcatheter aortic valve replacement with an HLT Transcatheter Aortic Valve System
16100514|NCT02159781|Procedure|periodontal treatment - scaling and root planning|
16100515|NCT02159768|Device|Airtraq visualization|Larynx visualization with Airtraq and attached handphone
16100520|NCT02159742|Other|Data Collection|
16100521|NCT02159729|Drug|Placebo|Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events
16100522|NCT02159729|Drug|ATX-101 (1 mg/cm^2)|Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events
16100523|NCT02159729|Drug|ATX-101 (2 mg/cm^2)|Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events
16100524|NCT02159729|Drug|ATX-101 (4 mg/cm^2)|Clinical evaluation, patient reported outcome questionnaires, photographs, caliper measurements and recording adverse events
16100525|NCT02159716|Biological|CART-meso|CART-meso are autologous T cells lentivirally transduced with chimeric anti-mesothelin immunoreceptor SS1 fused to the 4-1BB and CD3ζ signaling domains.
16100526|NCT02159703|Procedure|TORS|
16100527|NCT02159703|Radiation|Adjuvant Radiation Therapy|
16100528|NCT02159690|Drug|Enzalutamide|160mg
16100529|NCT02159690|Drug|Abiraterone acetate|1000mg
16100530|NCT02159690|Drug|Prednisone|5mg twice daily (to blunt mineralocorticoid side effects from abiraterone)
16100531|NCT02159690|Drug|Dutasteride|0.5mg
16100532|NCT02159690|Drug|Degarelix|240mg SC loading dose on day 1, then three 80mg SC injections every 4 weeks thereafter
16100533|NCT02159677|Device|EIM Measurements|
16100534|NCT02159664|Other|didgeridoo practice|instrument lessons, 1X/w and daily practice, 20 min /d
16100535|NCT02159651|Drug|tacrolimus|oral
16100536|NCT02159638|Device|Guardian Enlite sensor|Sensor insertion
16100537|NCT02159638|Device|Dexcom G4 platinum sensor|Sensor insertion
16100538|NCT02159625|Device|Abdominal Compression Elastic Support|The ACES will be used for HD patients who have had IDH episodes in the last month. For these patients, the ACES will impose a compression pressure of 15 mmHg to compress the abdominal section over the last three hours of the HD treatment. This action can increase venous return and hence cardiac output to improve the cardiovascular function of the patient. In this way, the IDH episode may be prevented or reduced in severity. This use is much less cumbersome over the use of IAB in dealing with PDOH. We perform this trial study to show the use ACES is more effective than the Trendelenburg maneuver or the infusion of isotonic saline, for example.
16100539|NCT02159612|Other|MRI|MRI scan of muscles in the back and legs. Including T1, DIXON and STIR images.
16100540|NCT02159599|Drug|Darunavir/Ritonavir|Darunavir/ritonavir (800/100 mg): QD (quaque die )
16100541|NCT02159599|Drug|Lamivudine|Lamivudine (300mg) : QD
16100542|NCT02159599|Drug|Emtricitabine/tenofovir or abacavir/lamivudine|Emtricitabine/tenofovir (300/200 mg) or abacavir/lamivudine (600/300 mg): QD
16100543|NCT02159573|Biological|natalizumab|Administered as per routine clinical practice
16100544|NCT02159573|Drug|dimethyl fumarate|Administered as per routine clinical practice
16100545|NCT02159560|Device|Epidural catheter|The intervention is the use of an end-holed epidural catheter or three-holed side port epidural catheter
16100546|NCT02159547|Drug|Dexketoprofen|50 mg intravenous arveles in 50 ml saline in 5 minutes
16100547|NCT02159547|Other|Normal Saline|50 ml normal saline
16100548|NCT02159534|Other|Primebrain|Primebrain stimulation programme aims to facilitate the infant's self-organization of postural competences by proposing varied sensorimotor experiences in a context supporting parent-child interaction.
16100549|NCT02159521|Device|EkoSonic® Endovascular System|
16100550|NCT02159521|Biological|Alteplase|Recombinant tissue plasminogen activator
16100551|NCT02159508|Behavioral|Nutritional counselling|In both study arms, daily estimated energy requirements were calculated from the basal energy requirements according to WHO multiplied by a 1.5 activity factor and protein requirement (g/day) was calculated multiplying ideal body weight (defined as BMI 22) by 1.2 to 1.5.
16100552|NCT02159495|Drug|cyclophosphamide|Given IV
16100553|NCT02159495|Biological|Autologous CD123CAR-CD28-CD3zeta-EGFRt-expressing T Lymphocytes|Given IV
16100554|NCT02159495|Other|laboratory biomarker analysis|Correlative studies
16100555|NCT02159495|Biological|Allogeneic CD123CAR-CD28-CD3zeta-EGFRt-expressing T-lymphocytes|Given IV
16100556|NCT02159495|Drug|Fludarabine Phosphate|Given IV
16100557|NCT02159482|Drug|Interferon Alfa-2a|
16100558|NCT02159469|Combination Product|Testosterone enanthate auto-injector|Dose Adjustment to 50 mg or 75 mg or 100 mg based upon Testosterone levels
16100559|NCT02159456|Other|Continuous enteral feeding via infusion pump|
16100560|NCT02159456|Other|Intermittent enteral feeding via gravity-based infusion|
16100561|NCT02159430|Other|Clinical and psychopathological assessment of HAE patients|
16100562|NCT02159417|Other|Therapeutic Education|"Realization of a consultation of educational diagnosis, followed by the participation for every patient to 4 educational collective workshops therapeutic:
~Knowledge of the disease
~Food
~Physical Activity and care of feet
~The therapeutics"
16100563|NCT02159404|Biological|Immunotherapy|
16100564|NCT02159391|Behavioral|Brief Motivational Interview|The Brief Motivational Interview implies an empathic interviewing style which (i) recognizes, examines and tries to resolve the patient´s ambivalence to facilitate behavioral change, (ii) promotes self-efficacy, (iii) allows flexibility in strategies, including short-term aims to reduce consumption and decrease damage linked to this consumption (like road accidents), (iv) works to reduce the patient's resistances, and (v) provides individualized feedback, if deemed appropriate, to promote recognition of the problem and cognitive restructuring.
16100565|NCT02159378|Other|Fructosamines|
16100566|NCT02159365|Drug|Elotuzumab|
16100567|NCT02159365|Drug|Lenalidomide|
16100568|NCT02159365|Drug|Dexamethasone|
16100569|NCT02159352|Drug|Daclatasvir|
16100572|NCT02159352|Drug|Lopinavir/Ritonavir|
16100573|NCT02159326|Drug|Microgynon|single oral tablet dose of Microgynon (0.03 mg EE and 0.15 mg LNG, fasted)
16100574|NCT02159326|Drug|Riociguat (Adempas,BAY63-2521)|multiple oral tablet doses of 2.5 mg riociguat TID over 12 days and, on the seventh day of this treatment
16100575|NCT02159313|Drug|Riociguat(Adempas,BAY63-2521)|Single dose of a whole 2.5 mg riociguat tablet
16100576|NCT02159300|Behavioral|experience brain activity recording|Intervention: experience brain activity recording
16100577|NCT02159287|Drug|Enoxaparin|1 mg of enoxaparin per kilogram of body weight subcutaneous every 12 hour
16100578|NCT02159287|Drug|Heparin|1000 unit per hour continuous intravenous infusion of heparin sodium
16100579|NCT02159261|Drug|BAY98-7071_EE20/DRSP/L-5-MTHF|Patients treated by Physicians under approved local prescriptions
16100580|NCT02159248|Drug|Tolfenamic acid + gemcitabine + radiation|"Cohort 1: 200mg of oral tolfenamic acid, three times per day for 6 1/2 weeks, in combination with weekly intravenous gemcitabine at 400mg/m2 for 5 doses and external beam radiation for 5 1/2 weeks (28 doses at 1.8 Gy/Fx/day).
~Cohort 2: 400mg of oral tolfenamic acid, three times per day for 6 1/2 weeks, in combination with weekly intravenous gemcitabine at 400mg/m2 for 5 doses and external beam radiation for 5 1/2 weeks (28 doses at 1.8 Gy/Fx/day).
~Cohort 3: 600mg of oral tolfenamic acid, three times per day for 6 1/2 weeks, in combination with weekly intravenous gemcitabine at 400mg/m2 for 5 doses and external beam radiation for 5 1/2 weeks (28 doses at 1.8 Gy/Fx/day).
~Cohort 4: 800mg of oral tolfenamic acid, three times per day for 6 1/2 weeks, in combination with weekly intravenous gemcitabine at 400mg/m2 for 5 doses and external beam radiation for 5 1/2 weeks (28 doses at 1.8 Gy/Fx/day)."
16100581|NCT02159222|Procedure|Additional physical therapy|
16100582|NCT02159196|Drug|acetylcysteine and salbutamol|routine nebulisation of a 3 mL-solution of acetylcysteine (fluimucil 100mg/ml) and a 2.5 mL solution containing salbutamol (ventolin 2.5 Nebules 2.5mg/2.5 ml) four times daily
16100583|NCT02159196|Drug|acetylcysteine|nebulisation of acetylcysteine on strict clinical indications only', i.e. in case of occurrence of persistent thick and tenacious sputum
16100584|NCT02159196|Drug|salbutamol|nebulisation of salbutamol on strict clinical indications only', i.e. in case of occurrence of bronchospasm
16100585|NCT02159183|Device|Standard Plus ESTA STL Roxolid implant|The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø 4.1 mm Regular Neck, SLActive® Roxolid, with a modified surface of the neck (ESTA). At 8-12 weeks after insertion, the implant will be loaded.
16100586|NCT02159183|Device|Standard Plus STL implant|The patient will receive a Straumann Soft Tissue Level Standard Plus Implant Ø4.1mm Regular Neck,SLActive® Titanium grade IV, with a machined surface of the neck. At 8-12 weeks after insertion, the implant will be loaded.
16100587|NCT02159170|Biological|NGF injection|single injection of NGF into the volar forearm / single injection of NaCl into the volar forearm
16100588|NCT02159157|Behavioral|Exercise prescription|A physical therapist will design an exercise plan for each participant on the intervention arm. The participants randomized to the intervention arm will also receive phone calls to assist with tracking the study participant's exercise and motivating the study participant to adhere to the exercise prescription.
16100589|NCT02159144|Other|cold stress|
16100590|NCT02159131|Drug|Ethinyl Estadiol|EE is available as a combination of EE 0.03 mg and LNG 0.15mg, a monophasic oral contraceptive tablet to be taken along with 240 mL water
16100591|NCT02159131|Drug|Levonorgestrel|LNG is available as a combination of EE 0.03 mg and LNG 0.15mg, a monophasic oral contraceptive tablet to be taken along with 240 mL water
16100592|NCT02159131|Drug|GSK1265744|GSK1265744 is available as 30 mg tablet to be taken along with 240 mL water
16100593|NCT02159118|Device|Manual bone marrow aspiration and biopsy device|Use of the manual bone marrow aspiration and biopsy device to collect bone marrow aspiration and bone marrow biopsy specimens.
16100594|NCT02159118|Device|Powered bone marrow aspiration and biopsy device|Use of the powered bone marrow aspiration and biopsy device to collect bone marrow aspiration specimens and bone marrow biopsy specimens.
16100595|NCT02159105|Device|FAST scan and non-invasive hemoglobin measurement|"A FAST scan, or abdominal ultrasound will be performed within one hour of cesarean delivery to establish normal levels of postoperative intraabdominal fluid.
~Women will also have their hemoglobin measured via a non-invasive method, the Masimo Pronto 7, at 3 time points: immediately prior to surgery (within 2 hours), immediately after surgery (within 1 hour), and the morning following surgery (within 24 hours)."
16100596|NCT02159092|Behavioral|Contingency Management|Monetary incentive for the CM groups is contingent on a saliva cotinine reading that indicates smoking abstinence. Participants were assessed 10 times (Mondays/Thursdays) for abstinence from smoking waterpipe verified by saliva cotinine. The maximum monetary incentives this group can receive is $192.50. The CM groups followed an escalating schedule where: 1) the dollar amount of the incentive increases by $.50 as long as the participant is abstinent at each visit;; and 2) resets to the starting incentive ($14) if the participant was non-compliant at the previous visit, but is compliant at the current visit. Also, Participants were given $10 bonus for every three consecutive compliant visits.
16100597|NCT02159079|Other|Conservative Fluid Management Strategy|For patients in the conservative fluid management arm, beginning 12 hours after admission to study ICU and ending at the first of ICU discharge, death, return to home inspired oxygen, or study day 14, fluid management will be controlled by a study protocol. Patients in shock will receive fluid boluses only as specified by the protocol for oliguria and rapidly increasing vasopressor requirement. Patients not in shock will receive fluid boluses only as specified by the protocol for oliguria. Output will exceed input each day using a diuretic drip if required. Study protocol will be held only for pre-specified Safety Endpoints of persistent oliguria, decompensating shock, diuretic side effect, and intervening acute event.
16100598|NCT02159066|Drug|LGX818|Combination of LGX818 and MEK162 (Part I)
16100599|NCT02159066|Drug|MEK162|Combination of LGX818 and MEK162 (Part I)
16100600|NCT02159066|Drug|LEE011|Combination of LGX818 + MEK162 + LEE011 (Part II)
16100601|NCT02159066|Drug|BGJ398|Combination of LGX818 + MEK162 + BGJ398 (Part II)
16100602|NCT02159066|Drug|BKM120|Combination of LGX818 + MEK162 + BKM120 (Part II)
16100603|NCT02159066|Drug|INC280|Combination of LGX818 + MEK162 + INC280 (Part II)
16100604|NCT02159053|Biological|Secukinumab|Eligible subjects are randomized to each of the three treatment arms in a 1:1:1 ratio
16100933|NCT02156323|Drug|CMS|Multiple doses of CMS over 2.5 days
16100605|NCT02159053|Biological|Secukinumab|Eligible subjects are randomized to each of the three treatment arms in 1:1:1 ratio
16100606|NCT02159053|Biological|Placebo|Eligible subjects are randomized to each of the three treatment arms in a 1:1:1 ratio
16100607|NCT02159040|Drug|Azacitidine|SC or IV AZA at 75mg/m2 7 days/28 day cycle
16100608|NCT02159040|Drug|Azacitidine plus Deferasirox|SC or IV AZA at 75mg/m2 7 days/28 day cycle DFX 10mg/kg/day
16100609|NCT02159027|Drug|Maraviroc|Maraviroc administered twice daily, dosage based on concomitant medication being taken.
16100610|NCT02159027|Drug|Placebo|Maraviroc placebo administered twice daily, dosage based on concomitant medication being taken.
16100611|NCT02159014|Behavioral|Facilitated group-based aerobic dance|Physical activity facilitated by instructor
16100612|NCT02159014|Behavioral|Online, video prompted, individual aerobic dance|Supported online activity intervention
16100613|NCT02159014|Behavioral|Facilitated group-based nutritional intervention|Education, skill training, access and use of NHS Change4Life Eat Well web resource
16100614|NCT02159014|Behavioral|Self-paced online aerobic dance activity|Self paced physical activity
16100615|NCT02159014|Behavioral|Individual self-paced nutritional intervention|Individual use of online nutritional advice resources.
16100616|NCT02159001|Device|electroconvulsive therapy|10-course, three times a week bilateral frontotemporal ECT
16100617|NCT02158988|Procedure|HIPEC|"HIPEC:
~Mitomycin C: 15 mg/m2 (max. 30 mg/ m2, max. 5 L Perfusion). Cisplatin: 75 mg/m2/L (max. 150 mg/m2, max. 5 L Perfusion). 4-12 weeks after cytoreductive surgery 3 cycles postoperative chemotherapy will be applied."
16100618|NCT02158975|Drug|MLN9708|
16100619|NCT02158962|Behavioral|Behavioral - Education|"Behavioral - Education
~3 educational sessions aimed at reducing risks partner violence, and sexual transmitted infections"
16100620|NCT02158949|Behavioral|mROAD|
16100621|NCT02158936|Drug|Eltrombopag|Eltrombopag will be round film-coated tablets containing eltrombopag equivalent to 50 mg (white to off-white), 200 mg and 300 mg (green) of eltrombopag free acid
16100622|NCT02158936|Drug|Azacitidine|Subcutaneous Injection (IV if local standard)
16100623|NCT02158936|Drug|Placebo|Eltrombopag matching placebo tablets
16100624|NCT02158936|Drug|Placebo|Eltrombopag matching placebo tablets will be supplied
16100625|NCT02158923|Procedure|Alveolar recruitment maneuver|To start Alveolar Recruitment Maneuver (ARM), change ventilatory pressure-controlled mode (PCV) with 15 cmH2O pressure control ventilation. A respiratory rate (RR) of 15 rpm, inspiration: expiration ratio of 1:1, FiO2 of 0.8 and PEEP of 10 cmH2O. PEEP level will increase 5 on 5 cmH2O every 10 respiratory cycles, increasing to 15 cycles in the last level of PEEP (25 cmH2O), getting an opening pressure at 40 cmH2O airway (duration of the maneuver: 160 sec.)
16100626|NCT02158923|Procedure|Calculation of optimal PEEP|Change ventilation mode to volume controlled ventilation (VCV) with a VT of 8 ml / kg, RR 15 rpm and adjust a PEEP of 20 cmH2O. Descend PEEP level 2 by 2 cmH2O every 30 seconds until obtain the best respiratory system compliance (Crs) PEEP. Once you know the optimal level of PEEP (best Crs PEEP), will be conducted again alveolar recruitment maneuver and adjust the best Crs level of PEEP + 2 cmH2O .
16100627|NCT02158923|Procedure|Postoperative CPAP|Postoperatively, non-invasive mechanical ventilation with a CPAP of 5 cmH2O (or 10 cmH2O if BMI> 30) with a FiO2 of 0.5 will be applied.
16100628|NCT02158910|Drug|Aricept|5 mg Aricept increasing dose to 10 mg Aricept, or 10 mg Aricept increasing dose to 23 mg Aricept
16100629|NCT02158897|Other|Prolon diet|3 cycles of a 5-day Prolon diet very month
16100630|NCT02158884|Device|IDEO brace|All participants will receive the IDEO brace.
16100631|NCT02158871|Behavioral|Beyond Silence|Pilot data from initial phases of the project and best practice principles in contact based education and adult learning theory informed curriculum design. The six in-person sessions use workplace-based vignettes to prompt reflection and discussion, build mental health literacy, reduce stigma, and promote communication and coping skill development. The virtual sessions use a secure online discussion board for participants to explore relevant online resources. All sessions will be co-led by trained peer educators; employees who have personally experienced mental ill health and recovery and are viewed as credible leaders within the organization. They will be recruited and trained to effectively teach the content, share personal experiences, and facilitate discussion.
16100632|NCT02158871|Behavioral|Mental Health First Aid (MHFA)|MHFA is a standardized, twelve-hour educational program designed to teach participants how to recognize the early warning signs of mental illness, how to provide initial help to someone in a mental health crisis, and how to support people who are developing mental health problems. It is an evidence-based approach that originated in Australia, but is being implemented across Canada, under the leadership of the Mental Health Commission of Canada. Leadership of the MHFA will be provided by an employee in each organization who has been trained through the 5-day national MHFA instructor training program. The instructor does not share any personal experiences regarding mental health issues.
16100633|NCT02158858|Drug|CPI-0610|
16100634|NCT02158858|Drug|Ruxolitinib|
16100635|NCT02158845|Drug|LNG-IUS: levonorgestrel intrauterine system|LNG-IUS (levonorgestrel intrauterine system) is inserted until the fifth day of the cycle. It releases 20 mcg/day of LNG
16100636|NCT02158845|Drug|GnRHa: leuprolide|3.75 mg leuprolide injected intramuscularly on a monthly basis
16100637|NCT02158832|Device|Acupuncture + Electrical Stimulation|"2 acupuncture needles are inserted into the upper back. 10Hz, 0.5ms biphasic square wave electrical pulses are applied to needles x20 mins. Current >sensation threshold & maintained at a level that is comfortable/painless & does not elicit skeletal muscle contractions (~5mA, <10mA).
~Needle locations are in the vicinity of nerves that supply the affected upper limb:
~EX-B1': Affected hemisphere, 1.5cm lateral to C5 spinous process. Insertion angle: shallow, 'inferior-lateral', ~15⁰ perpendicular to the skin, ~15⁰ lateral to the midline. Depth: ~1.5 cm (secure anchorage).
~EX-HN15': Affected hemisphere, 1.5cm lateral to the C7 spinous process. Insertion angle: shallow, 'inferior-medial' ~15⁰ perpendicular to the skin, ~15⁰ medial. Depth: ~1.5 cm (secure anchorage)."
16100638|NCT02158819|Device|Total knee arthroplasty with Visionaire|Patient Specific Instrumentation
16100639|NCT02158806|Drug|Aspirin|150 mg aspirin in capsule form once daily for up to 24 weeks
16100640|NCT02158806|Drug|Placebo|Matching placebo capsule containing inert bulking agent
16100641|NCT02158793|Procedure|Craniomaxillofacial allotransplantation|Transplantation of donor face
16100642|NCT02158780|Procedure|Scrotal Orchidopexy|Single incision
16100643|NCT02158780|Procedure|Inguinal Orchidopexy|Double Incision (Standard)
16100644|NCT02158767|Biological|Allogenic T cell-depleted hematopoietic stem cell transplantation|Undergo CD34+ enriched T-cell depleted allogeneic peripheral blood stem cell transplant. T-cells will be removed using the experimental CliniMACS(r) Reagent System used in vitro to select and enrich CD34+ cells
16100645|NCT02158754|Diagnostic Test|Corus CAD (ASGES)|
16100646|NCT02158741|Behavioral|Home Visits and Lifestyle Education Support|
16100647|NCT02158715|Device|Site of smartphone on chest compressor' arm|
16100648|NCT02158702|Drug|Pomalidomide and Dexamethasone|Pomalidomide will be given at 4mg once daily for 21 days in a 28-day cycle. Dexamethasone will be given at a dose of 40mg orally once a week for 4 weeks (D1,8,15,22).
16100649|NCT02158689|Drug|Letrozole|
16100650|NCT02158689|Drug|human menopausal gonadotropin (hMG)|
16100651|NCT02158676|Dietary Supplement|Prebiotic|Fructooligosaccharides
16100652|NCT02158676|Dietary Supplement|Synbiotic|Fructooligosaccharides + Lactobacillus paracasei LPC-37 + Lactobacillus rhamnosus HN001 + Lactobacillus acidophilus NCFM + Bifidobacterium lactis HN019
16100653|NCT02158676|Other|Placebo|Maltodextrin
16100654|NCT02158663|Device|Repetitive Transcranial Magnetic Stimulation|TMS Device
16100655|NCT02158650|Behavioral|Video-Based Informed Consent|
16100656|NCT02158624|Drug|Intravitreal Lucentis 0.5mg|
16100657|NCT02158611|Other|Lifestyle counseling|
16100658|NCT02158598|Drug|Vitamin D chewable tablet supplementation|
16100659|NCT02158598|Drug|Vitamin D pill supplementation|
16100660|NCT02158585|Drug|Lamotrigine|Lamotrigine will be taken orally on a daily basis for the duration of 20 weeks, consisting of a six-week titration, 12-week study period, and two-week taper. Possible doses for patients are 25mg twice a day, 50mg twice a day, 100 mg twice a day and 150mg twice a day during titration; 150mg twice a day or 100mg twice a day for the 12-week study period; 150mg once a day or 100mg once a day for Week 1 of the taper; and 75mg once a day, or 50mg once a day for Week 2 of the taper. Each increase in dose will be maintained for two weeks before deciding to further increase or decrease based on tolerability. Patients who discontinue at any point of the study will have a two-week taper consisting of the current dose once a day for one week followed by half the dose once a day for another week.
16100661|NCT02158585|Drug|Placebo|The placebo will match the lamotrigine dosage, frequency and duration.
16100662|NCT02158572|Drug|AG200-15|Transdermal contraceptive delivery system
16100663|NCT02158559|Drug|Danhong Injection|Danhong injection 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 7 days;
16100664|NCT02158559|Drug|Normal Saline|0.9% sodium chloride solution 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 7 days;
16100665|NCT02158546|Drug|ALKS 5461|Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
16100666|NCT02158546|Drug|Placebo|Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
16100667|NCT02158533|Drug|High Dose ALKS 5461|Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
16100668|NCT02158533|Drug|Low Dose ALKS 5461|Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
16100669|NCT02158533|Drug|Placebo|Sublingual tablet, taken once daily (in addition to open-label treatment with a commercially available antidepressant)
16100670|NCT02158520|Biological|Bevacizumab|Given IV
16100671|NCT02158520|Biological|Ipilimumab|Given IV
16100672|NCT02158520|Other|Laboratory Biomarker Analysis|Correlative studies
16100673|NCT02158520|Drug|Nab-paclitaxel|Given IV
16100674|NCT02158520|Other|Pharmacological Study|Correlative studies
16100675|NCT02158507|Drug|Combination of Veliparib + Lapatinib|Treatment cannot be in administered conjunction with other chemotherapy, targeted therapy, radiation therapy, or other investigational drugs.
16100676|NCT02158494|Device|Balance and Gait Training using neurostimulation modulation.|CN-NINM uses sequenced patterns of electrical stimulation on the tongue. Our hypothesis is that CN-NINM induces neuroplasticity by noninvasive stimulation of two major cranial nerves: trigeminal, CN-V, and facial, CN-VII.
16100677|NCT02158494|Device|Sham Device|The sham device is visually identical to the CN-NINM device, and offers a non-zero, minimally perceivable stimulation.
16100678|NCT02158481|Dietary Supplement|A capsule containing both polyphenols and carotenoids|
16100679|NCT02158481|Dietary Supplement|Placebo intervention|Placebo intervention
16100680|NCT02158468|Device|Combined intrahospital pre- and postconditioning|After admission to hospital 3 cycles of preconditioning with 5-min inflation and 5-min deflation of a blood-pressure cuff. After primary PCI/stenting 4 cycles of postconditioning (30s ischemia and 30s reperfusion)
16100681|NCT02158468|Device|Postconditioning|After primary PCI/stenting 4 cycles of postconditioning (30s ischemia and 30s reperfusion)
16100682|NCT02158455|Procedure|NT SVG grafts|
16100683|NCT02158442|Procedure|Percutaneous Isolated Limb Perfusion (PILP) delivery|The Percutaneous Isolated Limb Perfusion (PILP) delivery intervention procedure enables the use of existing antibiotic therapies in a more targeted and aggressive fashion; it addresses limitations associated with the use of conventional antibiotic drug delivery. As part of the procedure, the circulation of the limb is isolated separately from the general circulatory system enabling the delivery of antibiotic at high therapeutic doses that are not achievable when standard doses are administered intravenously.
16100684|NCT02158442|Drug|Timentin|The Control Group will receive standard dosings of intravenous Timentin plus other standard care.
16100685|NCT02158429|Other|2 dimensional vs. 3 dimensional ultrasound|At the end of a regularly scheduled ultrasound measuring fetal growth an additional 5-10 minute ultrasound will be performed, either in 2-dimensional or 3-dimensional mode
16100686|NCT02158403|Other|Clinical Management Recommendations for reducing pump thrombosis|Clinical Management Recommendations for reducing pump thrombosis
16100738|NCT02157948|Drug|Denosumab (CP2)|Denosumab produced by a process referred to as CP2, administered subcutaneously from a prefilled syringe.
16100739|NCT02157948|Drug|Denosumab (CP4)|Denosumab produced by a process referred to as CP4, administered subcutaneously from a prefilled syringe.
16101172|NCT02154451|Device|Infrared Imaging Device- ALIAS|Infrared Camera
16100687|NCT02158390|Behavioral|Jasper-EMT with words and AAC|"Jasper-EMT with words and AAC
~A therapist plus parent implemented social communication intervention which include use of the iPad for a mode of communication. A total of 6 hour long workshops with the parent and 42 hour long intervention sessions with the child occur; half include the parent as therapist and occur in the home. The treatment lasts approximately 4 months."
16100688|NCT02158377|Device|Trabecular metal dental implants (TM)|Patients receive TM dental implants in this arm. The early stability is measured and compared to the stability of the TSV implants. The implants are loaded and provisionalized early at 3 or 6 weeks if stability permits.
16100689|NCT02158377|Device|Tapered screw-vent implants (TSV)|Patients receive TSV dental implants in this arm. The early stability is measured and compared to the stability of the TM implants. The implants are loaded and provisionalized early at 3 or 6 weeks if stability permits.
16100690|NCT02158364|Drug|Freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain)|Freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain)
16100691|NCT02158351|Procedure|liver and white adipose tissue biopsies|
16100692|NCT02158338|Other|Asthma|mothers who have children that have been diagnosed with respiratory issues
16100693|NCT02158338|Other|Non-asthma|mothers who have children that do not have a diagnosis of respiratory problems
16100694|NCT02158325|Procedure|anterior capsulorhexis sizes|Pediatric cataract surgery performed with different anterior capsulorhexis sizes (3.0~3.9, 4.0~5.0, 5.1~6.0 mm in diameter)
16100695|NCT02158312|Device|Magstim Eldith DC-stimulator(Magstim Co., Whitland, UK)|2 mA for 20 minutes transcranial direct current stimulation
16100696|NCT02158299|Drug|Avitene|
16100697|NCT02158299|Drug|Sapylin|
16100698|NCT02158299|Behavioral|axillary drainage|
16100699|NCT02158299|Other|reexamine|
16100700|NCT02158286|Other|Measuring emptying rate from the gastric tube|
16100701|NCT02158273|Drug|Sugar Pill|145 mg/day, oral pill, 9 days
16100702|NCT02158273|Drug|TRICOR (fenofibrate)|145 mg/day, oral pill, 9 days
16100703|NCT02158260|Behavioral|Position changing|
16100704|NCT02158234|Drug|Cisplatin|Cisplatin 15 mg/m^2 prior to each fraction
16100705|NCT02158234|Radiation|Stereotactic Body Radiation Therapy (SBRT)|All participants will be treated every other day (excluding Saturday/Sunday). Starting Dose: 6 Gy/ Fraction 5/ Total 30 Gy.
16100706|NCT02158221|Drug|PACAP|Pituitary adenylate cyclase-activating polypeptide (PACAP)
16100707|NCT02158208|Other|Blood sample drawn into a 5 mL dry tube at the diagnosis and after 3 months of treatment|
16100708|NCT02158208|Other|16 blood samples drawn into 6 mL heparinized tubes at the diagnosis and after 3 months of treatment|
16100709|NCT02158208|Other|Blood sample drawn into a 5 mL dry tube|
16100710|NCT02158208|Other|16 blood samples drawn into 6 mL heparinized tubes|
16100711|NCT02158195|Biological|blood samples|
16100712|NCT02158182|Drug|Lactulose|30 ml by mouth three times daily until melena resolved, then adjusted to dose-response to obtain two to three soft stools. Duration of therapy: 7 days
16100713|NCT02158182|Drug|L-ornithine L-aspartate|10 grams by intravenous way for 24 hours. Duration of therapy: 7 days
16100714|NCT02158182|Drug|Rifaximin|2 tablets (400mg) three times daily. Duration of therapy: 7 days
16100715|NCT02158182|Drug|Placebo|"Placebo (for lactulose) 30ml of dextrose solution by mouth three times daily, for 7 days.
~Placebo (for L-ornithine L-aspartate) saline solution 500ml by intravenous way for 24 hours, for 7 days.
~Placebo (for rifaximin) 2 dextrose tablets three times daily for 7 days."
16100716|NCT02158156|Behavioral|Exercise|Ten weeks of home-training on a cycle ergometer 3 times a week for 30 minutes.
16100717|NCT02158143|Dietary Supplement|vitamin D3|
16100718|NCT02158117|Drug|nasal naloxone|one puff in one nostril with the subject is lying down
16100719|NCT02158104|Procedure|Deep dry needling|
16100720|NCT02158091|Drug|IPI-145|oral PI3K delta/gamma inhibitor
16100721|NCT02158091|Drug|Fludarabine|intravenous chemotherapy
16100722|NCT02158091|Drug|Cyclophosphamide|intravenous chemotherapy
16100723|NCT02158091|Drug|Rituximab|intravenous immunotherapy
16100724|NCT02158078|Device|PaQ® Insulin Delivery Device|PaQ is a 3 day insulin delivery device. Utilizes U 100 rapid-acting insulin. Provides basal insulin at preset basal doses and bolus insulin (in 2 unit increments) with a push of a button.
16100725|NCT02158065|Other|Coaching program|The coaching program consists of a (1) Step counter used as a coaching activity monitor to collect number of steps walked by the patients and (2) the Linkcare System, a mobile phone or tablet PC placed in the patient's home to collect data from the step counter. The system will set a daily activity goal for the patient based on achieved activity levels which will be measured by the step counter. Patients will also receive feedback, motivational and educational messages and direct calls from the coaching team at each institution.
16100726|NCT02158052|Drug|Tacrolimus|Tacrolimus starting on Day -1
16100727|NCT02158052|Drug|Equine Anti-thymocyte globulin|20 mg/kg IV on Days -3, -1, +1, +3
16100728|NCT02158052|Procedure|Kidney transplant from a related donor|On Day 0 the renal transplant is performed according to standard surgical techniques.
16100729|NCT02158052|Drug|Bone marrow transplant from a related donor|Donor bone marrow (> 2 x 10e8 nucleated cells/kg of recipient body weight) is prepared for infusion according to the standard procedure. The infusion begins in the operating room as soon as the vascular anastomosis of the renal allograft has been completed.
16100730|NCT02158052|Radiation|Total body irradiation 400 centigray (200 cGy X 2)|On transplant day -1
16100731|NCT02158039|Drug|Ethanol|EUS-guided lavage of a pancreatic cystic neoplasm with ethanol solution. Ethanol was diluted to 80% using normal saline.
16100732|NCT02158039|Drug|Lidocaine|The final solution contained 1% lidocaine except in subjects allergic to local anesthetics.
16100733|NCT02158013|Other|Levorag Emulgel|
16100734|NCT02158013|Drug|Diltiazem|
16100735|NCT02158000|Other|group A|one tab every 8 hs Diosmin ( 500mg) beginning from the day of ovum retrieval in addition to aspiration of the fluid by an IUI catheter
16100736|NCT02157987|Drug|bevacuzimab spray|
16100737|NCT02157974|Drug|Byetta 5Mcg Pen Injection|10 participants will receive 2 doses of Byetta, one at 7 PM the night prior to metabolic study and the second 30 min before ingestion of glucola
16100740|NCT02157935|Drug|Symbicort|Budesonide/formoterol pMDI, 160/4.5 μg x 2 actuations BID, for oral inhalation, 120 doses
16100741|NCT02157935|Drug|Formoterol turbohaler|Formoterol Turbuhaler 4.5 μg x 2 actuations BID, for oral inhalation, 60 doses
16100742|NCT02157935|Other|Placebo for Symbicort pMDI|pMDI, aerosol for oral inhalation, placebo, 120 doses
16100743|NCT02157935|Other|Placebo for Formoterol Turbohaler|PLacebo powder for oral inhalation, 60 doses
16100744|NCT02157922|Drug|alginate oligosaccharide|Inhalation
16100745|NCT02157909|Device|Lotrafilcon B sphere modified design contact lenses|
16100746|NCT02157909|Device|Lotrafilcon B sphere contact lenses|
16100747|NCT02157883|Procedure|Pharmacokinetic sampling|Blood samples taken pre and post dosing with AZD9291+/- itraconazole
16100748|NCT02157883|Drug|AZD9291|AZD9291 tablets: Part A 80mg od, days 1 and 10 only. Part B 80mg od for 12 months.
16100749|NCT02157883|Drug|Itraconazole|Itraconazole tablets: 2x100mg bd, Part A days 6 to 19 only
16100750|NCT02157831|Biological|CP-870,893|
16100751|NCT02157818|Drug|midazolam|
16100752|NCT02157818|Drug|Dexmedetomidine|
16100753|NCT02157805|Other|beef meat|"Meat cooking conditions
~st condition : beef meat cooked during 5 minutes at 55°C
~nd condition : beef meat cooked during 30 minutes à 90°C"
16100754|NCT02157792|Drug|M6620|
16100755|NCT02157792|Drug|Gemcitabine|
16100756|NCT02157792|Drug|Cisplatin|
16100757|NCT02157792|Drug|Etoposide|
16100758|NCT02157792|Drug|Carboplatin|
16100759|NCT02157792|Drug|Irinotecan|
16100760|NCT02157779|Behavioral|Cognitive Behavioral Intervention|Includes individual therapy sessions using cognitive and behavioral strategies addressing problems with anger intensity / frequency / management
16100761|NCT02157779|Behavioral|Supportive Intervention|Includes individual therapy sessions using supportive and problem-solving strategies.
16100762|NCT02157766|Behavioral|Intensive Meditation Practice|Long term meditators complete three days of of mindfulness or compassion/loving kindness meditation at T2 and T3 (one meditation type per visit).
16100763|NCT02157766|Behavioral|Mindfulness Based Stress Reduction|8 week class designed to enhance well-being through training in mindfulness.
16100764|NCT02157766|Behavioral|Health Enhancement Program|8 week class designed to enhance well-being through training in physical activity, functional movement, music therapy and nutrition.
16100765|NCT02157740|Device|Residents of nursing homes with telemedicine after implementation of telemedicine|
16100766|NCT02157727|Device|Infants hospitalized in health facilities performing Tele-expertise|
16100767|NCT02157714|Drug|PRX002|
16100768|NCT02157714|Other|Placebo|
16100769|NCT02157701|Dietary Supplement|Polyherbal capsule|
16100770|NCT02157701|Dietary Supplement|Placebo capsule|
16100771|NCT02157688|Other|no intervention : case control study|
16100772|NCT02157675|Dietary Supplement|Polyherbal capsule|
16100773|NCT02157675|Dietary Supplement|Placebo capsule|
16100774|NCT02157649|Drug|IR Tablet under Fasted conditions|Administration of IR Tablets combination of Codeine Phosphate/Guaifenesin 20mg/400mg every 4 hours for 12 hours total.
16100775|NCT02157649|Drug|ER Tablet under Fed Conditions|Administration of two ER Tablet combination of Codeine Phosphate/Guaifenesin 30mg/600mg
16100776|NCT02157649|Drug|ER Tablet under Fasted Conditions|Administration of two Codeine Phosphate/Guaifenesin 30mg/600mg ER Tablets under fasted conditions.
16100777|NCT02157636|Drug|CPI-0610|
16100778|NCT02157623|Drug|Levulan|Levulan application followed by Red or Blue light PDT
16100779|NCT02157623|Other|Red Light PDT|Aktilite™ (red lamp) after Levulan application on lesions
16100780|NCT02157623|Other|Blue Light PDT|Blu-U® (blue lamp) after Levulan application on lesions
16100781|NCT02157610|Behavioral|Self-Help Materials|Participants receive free self-help materials mailed at baseline, 6, and 12 months. and a referral to the Oklahoma Quitline.
16100782|NCT02157610|Drug|Nicotine Patch|Participants receive a 12-week supply of nicotine patch. Nicotine patch regime based on participant's self-reported smoking rate. Participants who smoke >10 cigarettes/day receive 8 weeks of 21 mg, 2 week of 14 mg, and 2 week of 7 mg patches. Those who smoke <10 cigarettes/day receive 8 weeks of 14 mg and 4 weeks of 7 mg patches.
16100783|NCT02157610|Behavioral|REDCap|REDCap will be used to collect all questionnaires data over the phone. Questionnaires done at baseline to randomize, then at 3, 6, 12, and 18 months.
16100784|NCT02157610|Procedure|Saliva Test|Saliva test performed at 3, 6, 12, and 18 months.
16100785|NCT02157610|Behavioral|Telephone Counseling Sessions|6 telephone counseling sessions performed over 12 months. Sessions performed at baseline, 3, 6, 12, and 18 months. Sessions digitally recorded.
16100786|NCT02157610|Drug|Nicotine lozenge|Participants receive a 12-week supply of nicotine lozenges. All participants receive 12 weeks of 2mg lozenges.
16100787|NCT02157597|Other|NIRS based management|"Check NIRS, mechanics, muscle relaxation, hemodynamics, ventilation, hematocrit, surgical repair
~Deepen anesthesia with volatile or intravenous agent.
~Consider Extra-Corporeal Membrane Oxygenation (ECMO)."
16100788|NCT02157597|Other|Control|During the Control Arm, the medical team completes all tasks as clinically necessary and in the best medical interest of the patient, without any input from the study procedures
16100789|NCT02157584|Drug|Telotristat etiprate|2 × 250 mg (as free base) telotristat etiprate tablets (fed conditions /high-fat / high caloric meal)
16100790|NCT02157584|Drug|Telotristat etiprate|2 × 250 mg (as free base) telotristat etiprate tablets (fasted conditions)
16100791|NCT02157571|Drug|Prulifloxacin|600 mg/tablet, oral administration of a single tablet.
16100792|NCT02157571|Drug|Levofloxacin|500 mg/tablet, oral administration of a tablet daily.
16100793|NCT02157571|Drug|Levofloxacin Placebo|Placebo of levofloxacin hydrochloride tablet, without active components.
16100794|NCT02157571|Drug|Prulifloxacin placebo|Placebo of prulifloxacin film-coated tablet without active components.
16100795|NCT02157558|Drug|Fexofenadine|All subjects will receive 180 mg fexofenadine
16100796|NCT02157558|Drug|Telotristat etiprate|All subjects will receive 500 mg (2 X 250 mg tablets) telotristat etiprate tablets three times daily
16100797|NCT02157532|Procedure|mechanical thrombectomy|Mechanical thrombectomy using any already approved stent-retriever device
16100798|NCT02157532|Drug|Best standard treatment|Intravenous r-tPA infusion or any other medical management option
16100799|NCT02157519|Other|Mobile Application Intervention|Participants assigned to the intervention group will receive the mobile application intervention for approximately three months after enrollment. The mobile app intervention will consist of completing an initial chemotherapy treatment plan, responding to weekly assessments regarding symptoms, side effects, and medication adherence, as well as receiving personalized feedback about responses. The results from patient surveys within the app will also be transmitted in real-time to the participants' oncology clinicians via a HIPAA-compliant, secure email.
16100800|NCT02157506|Drug|CXL-1427|
16100801|NCT02157506|Drug|Placebo|
16100802|NCT02157493|Behavioral|Arrowhead Business Group Curriculum|Arrowhead Business Group (ABG) is a culturally tailored entrepreneurship/life-skills intervention, which features instruction from American Indian paraprofessionals in an effort to decrease drug use, depressive symptoms, hopelessness and other high-risk behaviors among youth while improving their school performance and college/career aspirations.
16100803|NCT02157493|Behavioral|Recreational League Control Condition|The control condition will consist of a recreational sports league that will be led by local American Indian study staff who are experienced with Johns Hopkins camps and community-based Apache sports programs. Activities will be conducted on 3 Saturdays during the academic year to mixed gender groups of approximately 50 participants.
16100804|NCT02157480|Device|electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 3 days per week .|outpatient biquadricipital electrostimulation 3 days per week with an electrostimulator Compex2* (DJO, Vista, CA, USA)
16100805|NCT02157480|Device|electrostimulation (with Compex® Compex2* (DJO, Vista, CA, USA)) 5 days per week|outpatient biquadricipital electrostimulation 5 days per week with an electrostimulator Compex2* (DJO, Vista, CA, USA)
16100806|NCT02157467|Drug|BMS-955176|
16100807|NCT02157467|Drug|Ortho Cyclen|
16100808|NCT02157454|Other|Website access|Access to the colorectal cancer module of the website www.krankheitserfahrungen.de which provides free, reliable information about health issues by sharing people's real-life experiences
16100809|NCT02157441|Procedure|lower uterine compression sutures|intervention is lower uterine compression sutures (involved bilateral uterine artery ligation and compression of the lower uterine segment at the same time with one circular stitch) as a conservative treatment for the treatment of postpartum hemorrhage in women with placenta previa complete centralis.
16100810|NCT02157428|Drug|Flumazenil|
16100811|NCT02157428|Drug|saline|
16100812|NCT02157415|Device|Uro-Tainer Polihexanide 0.02%|Catheters will be rinsed by gravity feed with 100ml solution of UT-P 0.02% once a day for a maximum of 5 instillations.
16100813|NCT02157402|Behavioral|Social marketing activities and pop-up events to promote healthy lifestyles|
16100814|NCT02157389|Other|Administration of a pharmacological placebo|
16100815|NCT02157376|Drug|Esomeprazole|iv esomeprazole 30 min intermittent infusions given for maximum 14 days
16100816|NCT02157376|Drug|Cimetidine|iv cimetidine 30 min bolus infusion followed by iv cimetidine continuous infusion given for maximum 14 days
16100817|NCT02157363|Procedure|Repositioning|
16100818|NCT02157363|Procedure|Single positioning|
16100819|NCT02157350|Procedure|Panretinal laser photocoagulation|Panretinal photocoagulation. Laser energy is given to the retina in two sittings, carefully avoiding the macular. The energy are placed 2 to 3 disc diameters away from the macula and the disc outside the arcades and extended peripherally upto the equator and beyond.
16100820|NCT02157337|Drug|Atorvastatin|80 mg (PO) once daily for 6 days
16100821|NCT02157337|Drug|placebo|80 mg (PO) once daily for 6 days
16100822|NCT02157324|Drug|acalabrutinib|
16100823|NCT02157324|Drug|ACP-319|
16100824|NCT02157311|Drug|Four consecutive days on treatment and 3 days off|All patients will take a combination of three of these treatment with a weekly strategy of 4 consecutive days on treatment followed by 3 days off treatment
16100825|NCT02157298|Drug|Dapagliflozin 5 mg|Dapagliflozin, a blood glucose lowering drug. Oral dose
16100826|NCT02157298|Drug|Placebo tablet|Placebo tablet. Oral dose
16100827|NCT02157285|Behavioral|Peer Mentor Counseling|Peer mentoring will entail the peer mentor describing her positive experience with her LARC method. The participant will then have a chance to ask any experience related questions to the mentor. Any clinical inquiries or questions the mentor does not feel comfortable answering, she will defer to the contraceptive counselor/ physician who will be subsequently providing the routine counseling. The entire peer mentor encounter should not last more than 10 minutes.
16100828|NCT02157272|Drug|Experimental: Rivaroxaban|The investigated drug is Rivaroxaban 20mg, a film coated tablet, which is a highly selective direct factor Xa inhibitor. It should be administered orally, every day at any time (always the same), with food. The treatment should be performed for all the treatment period.
16100829|NCT02157246|Other|Pimonidazole|
16100830|NCT02157246|Other|F-MISO PET|
16100831|NCT02157246|Other|pCT|
16100832|NCT02157246|Other|Functional MRI|
16100833|NCT02157246|Procedure|Biopsy|
16100834|NCT02157246|Procedure|Blood sample|
16100835|NCT02157233|Behavioral|Rest|
16100836|NCT02157233|Behavioral|Exercise|
16100837|NCT02157220|Device|Fixed bearing prosthesis|
16100838|NCT02157220|Device|Mobile bearing prosthesis|
16100839|NCT02157207|Dietary Supplement|Antioxidant|Comparison of antioxidant supplementation with a placebo. Effects of race and age and race in repsonse to the supplementation will be evaluated.
16100840|NCT02157207|Other|Placebo|Comparison of antioxidant supplementation with a placebo. Effects of race and age and race in repsonse to the supplementation will be evaluated.
16100841|NCT02157181|Drug|2CdA +/- Rituximab|Cladribine 0.14 mg/kg daily subcutaneous bolus injection Rituximab 375 mg/m² infusion
16100879|NCT02156752|Behavioral|SR|Treatment is based on Self-Regulation theory.
16100880|NCT02156752|Behavioral|WLO|Treatment is based on cooking tips and demonstrations.
16100881|NCT02156739|Procedure|Contrast-enhanced Magnetic Resonance Imaging|Undergo contrast-enhanced MRI
16100882|NCT02156739|Drug|Gadobutrol|Given IV
16100883|NCT02156739|Drug|Gadoxetate Disodium|Given IV
16100884|NCT02156726|Drug|low-dose FCR|FCR with attenuated dose of fludarabine and cyclophosphamide
16100885|NCT02156713|Behavioral|CIMT Camp|
16100842|NCT02157168|Behavioral|Community health worker|"Community health workers (CHWs) in Hispanic communities, often referred to as promotoras, are members of the community who use resource sharing, partnership development, education, outreach, health promotion, and disease prevention strategies to improve the health of their communities.
~IG1: The intervention itself consists of a 45-minute one-on-one presentation and tailored planning session delivered by a CHW in a community setting of the new member's choosing. Presentations (in English or Spanish) will be delivered using a tablet computer or a hand held flipchart. Two booster telephone interactions will be performed at 2 and 4 months. At month 6, the participant will receive a call from the telephone interviewer to administer the informed patient choice survey."
16100843|NCT02157155|Biological|LPS|LPS is endotoxin from gram negative bacteria. It is used scientifically to mimic infection lasting 4-8 hours.
16100844|NCT02157142|Device|HLT Transcatheter Aortic Valve System|Transcatheter aortic valve replacement with an HLT Transcatheter Aortic Valve System
16100845|NCT02157129|Device|LipoAerosol© inhalation|LipoAerosol© inhalation, 5x/d for 30min
16100846|NCT02157129|Other|Physiologic saline inhalation|Physiologic saline inhalation, 5x/d for 30min
16100847|NCT02157116|Drug|cisplatin|
16100848|NCT02157116|Drug|Docetaxel|
16100849|NCT02157116|Drug|Pegfilgrastim|
16100850|NCT02157103|Drug|Bevacizumab 25 mg in 1 ml subcutaneously daily|Bevacizumab delivered by subcutaneous injection instead of intravenous infusion.
16100851|NCT02157090|Other|Herpes Patch SOS (Hansaplast®)|
16100852|NCT02157090|Other|Herpes vesicle patch of Compeed®|
16100853|NCT02157077|Drug|Aflibercept|Intravitreal Injection
16100854|NCT02157051|Biological|CD105/Yb-1/SOX2/CDH3/MDM2-polyepitope Plasmid DNA Vaccine|Given ID
16100855|NCT02157051|Other|Laboratory Biomarker Analysis|Correlative studies
16100856|NCT02157038|Device|Pedometer|
16100857|NCT02157038|Device|MRI|
16100858|NCT02157025|Device|Cartoon video fixation target and cartoon character voice audio instructions during Humphrey perimetry|
16100859|NCT02157025|Other|Usual Care procedures during Humphrey perimetry for children|
16100860|NCT02157012|Drug|The effectiveness of Xeljanz in rheumatoid arthritis patients|
16100861|NCT02156999|Device|Ibandronic acid, vitamin D|
16100862|NCT02156973|Other|Video information|A six minute information film to address the common themes raised by patients. This will clearly show the scanner, discuss the use of beta-blockers and radiation, and explain the likely side effects of x-ray dye (which can be alarming if patients are not expecting them). In this way we hope patients will be better prepared for the scan.
16100863|NCT02156960|Drug|Denosumab treatment in osteoporotic patients|To examine the effectiveness of denosumab in osteoporotic patients
16100864|NCT02156960|Drug|Teriparatide treatment in osteoporotic patients|To examine the effectiveness of teriparatide in osteoporotic patients
16100865|NCT02156960|Drug|Denosumab and teriparatide treatment in osteoporotic patients|To examine the effectiveness of denosumab and teriparatide in osteoporotic patients
16100866|NCT02156947|Procedure|Laparoscopic cholecystectomy|The technique used for LC was the conventional four-trocar approach (10-mm optic at the umbilicus, 10-mm trocar in the epigastrium and two 5-mm trocars in the right upper abdomen).
16100867|NCT02156934|Biological|paraurethral injection|Paraurethral injection of muscle derived stem cell in patients with stress urine incontinency.
16100868|NCT02156921|Other|App-based training|
16100869|NCT02156908|Drug|D-serine|D-serine 60 mg/kg
16100870|NCT02156869|Other|Decision aid|Intervention was use of a decision aid. Decision aid contained information about: 1) the epidemiology of prostate cancer; 2) what is a PSA test and advantages and limits of screening for prostate cancer using it (including risk of overtreatment and risk of becoming impotent and/or incontinent) and; 3) the position on screening for prostate cancer of major scientific societies in France at the time of the study. The second page contained a visual representation of the benefits of PSA screening for prostate cancer versus usual care based on the results of the European Randomized study of Screening for Prostate Cancer trial (ERSPC) The decision aid was pretested with 20 patients to ensure clarity and wording. It was revised accordingly to comments.
16100871|NCT02156843|Drug|Pyridorin|300 mg BID (twice daily, every 12 hours), oral capsule taken until end stage renal disease or death occurs, or the study is terminated by the sponsor.
16100872|NCT02156843|Drug|Placebo|Placebo excipients without the active drug, oral capsule taken BID (twice daily, every 12 hours), until end stage renal disease or death occurs, or the study is terminated by the sponsor.
16100873|NCT02156817|Other|Amplitude integrated electroencephalogram, Cardiorespiratory signal acquisition|
16100874|NCT02156804|Drug|Nivolumab (BMS-936558)|
16100875|NCT02156791|Biological|gpASIT+TM|
16100876|NCT02156778|Behavioral|Active Comparator: Extended Standard Care (Stroke Card)|"Standard Care plus
~extended training with access to weekly educational lectures (education of patients and relatives), implementation of My Stroke Card containing (a) an adopted version of the 'post-stroke checklist' (ascertainment of post-stroke complications), (b) self-administered internet-based tools for risk factor monitoring and reinforcement of target level achievement, and (c) information and educational materials.
~3-Mo outpatient appointment with standardized assessment of risk factors and screening for complications, health problems and residual deficits, estimation of the patient's demand for nursing services and support, guideline-conform secondary prevention with full achievement of target levels, assessment of patient adherence to drug prescriptions.
~6-Mo and 9-Mo visits on the discretion of the study team in case of medical needs.
~12-Mo clinical visit and outcome assessment."
16100877|NCT02156778|Behavioral|Active Comparator: Standard Care|"In-hospital training (education of patients, next of kin and caregivers on risk factor management and assessment, life style improvement, and compliance).
~Complimentary provision of a book / information material dealing with patient and caregiver relevant aspects of stroke care.
~Advise by a dietitian (general advise and individualized recommendations in patients with diabetes and obesity).
~Standardized information materials (e.g. for OAK or NOAK therapy). Support for smoking cessation and weight reduction if necessary or requested. Detailed medical reports (doctor's letter for the general practitioner and patient) at discharge containing target levels for risk factor management.
~AF detection at the Stroke Unit (1-5 day monitoring) and/or at the ward (24-hour ECG).
~12-Mo clinical visit and outcome assessment."
16100878|NCT02156752|Behavioral|ACT|Treatment is based on Acceptance and Commitment Therapy
16100886|NCT02156700|Procedure|Shear wave elastography|Measurement of tumor stiffness by Shear wave elastography - SWE™
16100887|NCT02156687|Device|Y mesh|Y mesh
16100888|NCT02156687|Device|Dual flat mesh|Dual flat mesh
16100889|NCT02156674|Drug|Naglazyme®|1 mg per kg of body weight administered once weekly as an intravenous infusion
16100890|NCT02156661|Drug|Oxytocin|
16100891|NCT02156648|Other|Feasibility study|All participants will have blood draws for biomarkers during the course of the study at visit 1, 2, 3, 4, 5, 6, 7 and 8. they will also have the speckle tracking echocardiogram at visit 1, 4, 5, 6, 7 and 8. For women 45 an over a cardiac PET scan will be performed at visit 1 and 5.
16100892|NCT02156635|Device|Transcranial direct current stimulation|
16100893|NCT02156635|Behavioral|Constraint-Induced Movement Therapy|
16100894|NCT02156635|Other|Placebo|
16100895|NCT02156609|Device|Percutaneous ventricular support with the HeartMate PHP|The HeartMate PHP device will be inserted percutaneously prior to the start of high risk coronary interventions (complex disease, reduced ejection fraction, etc.) to provide hemodynamic support,
16100896|NCT02156596|Drug|IV NSAI|100 mg of ketoprofen in 50 ml volume given in 30 minutes by IV root
16100897|NCT02156596|Drug|NM|3 nebulisations of 5 mg morphine chlorhydrate each given over 30 minutes (10 minutes per nebulisation)
16100898|NCT02156596|Drug|IV Serum Saline|50 ml of SS is given by IV root over 30 minutes
16100899|NCT02156596|Drug|Nebulised Serum Saline|3 nebulisations of 5ml SS each are given over 30 minutes
16100900|NCT02156570|Drug|Sofosbuvir and ribavirin|Sofosbuvir 400mg daily plus weight-based dosing ribavirin (1000mg <75kg, 1200mg >/= 75 kg) Treatment will be for 6 weeks in all participants.
16100901|NCT02156557|Biological|Colon KCC Heptapeptide|"Your colonoscopy will happen as it would normally, including the medications, the colonoscope, and any clinically indicated biopsies or polypectomies.
~The fluorescent peptide will be sprayed on to the walls of your colon around the areas that might have a polyp, areas of IBD, or another area of interest. Your doctor will select one area to apply the peptide in your colon. The peptide comes in a single-use sealed vial from the investigational pharmacy. Sterile saline (salt-water) is added to the vial. The powder is mixed well and pulled into a syringe. The peptide is then injected into a special, single-use sprayer, like a garden hose, that fits down the endoscope channel. The peptide will be sprayed in your colon. This is part of the study.
~The endoscopist will take pictures of the area before and after the peptide spraying. They will use the camera that is part of the colonoscope.
~We will obtain copies of your endoscopy report and any pathology reports."
16100902|NCT02156544|Drug|CKD-519|
16100903|NCT02156544|Drug|placebo|
16100904|NCT02156531|Behavioral|Self-Administered, Active Cognitive Bias Modification (CBM)|Cognitive Bias Modification (CBM) is a novel treatment delivered via a downloadable computer program. CBM retrains individuals' attention away from negative/threatening stimuli and toward more balanced attention toward neutral stimuli.
16100905|NCT02156531|Behavioral|Self-Administered, minimally effective attention-control version of the CBM program|Identical to the active CBM program except that during the presentation of the trails where a disgusted face is present, the probe will appear with equal frequency (50-50) in the position of disgusted or neutral face. This, the balanced (random) presentation of the probe in this condition is not designed to explicitly train attention away from threat and toward neutral stimuli, in contrast to the active version of CBM.
16100906|NCT02156518|Procedure|Vocal Function Exercises|Vocal Function Exercises
16100907|NCT02156518|Procedure|Vocal Hygiene|Vocal Hygiene
16100908|NCT02156505|Procedure|placement of double bare stent|
16100909|NCT02156505|Device|DoubleBare stent|
16100910|NCT02156492|Drug|Evacetrapib|Administered orally.
16100911|NCT02156492|Drug|Simvastatin|Administered orally.
16100912|NCT02156492|Drug|Atorvastatin|Administered orally.
16100913|NCT02156466|Drug|MSB0010841|MSB0010841(Anti- IL-17A/F Nanobody) will be administered at a dose of 30 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
16100914|NCT02156466|Drug|MSB0010841|MSB0010841 will be administered at a dose of 60 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
16100915|NCT02156466|Drug|MSB0010841|MSB0010841 will be administered at a dose of 120 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
16100916|NCT02156466|Drug|MSB0010841|MSB0010841 will be administered at a dose of 240 mg as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
16100917|NCT02156466|Drug|Placebo|Placebo matched to MSB0010841 will be administered as SC injection every other week (Day 1, Day 15 and Day 29) for a total duration of 6 weeks.
16100918|NCT02156453|Procedure|Total knee arthroplasty|All patients will undergo total knee replacement using midvastus approach by single surgeon.
16100919|NCT02156440|Dietary Supplement|SierraSil Joint Formula 14|667 mg SierraSil® hydrothermal mineral complex
16100920|NCT02156440|Dietary Supplement|Placebo|
16100921|NCT02156427|Device|VITICELL|graft of autologus cells (kaeratonicytes and melanocytes) obtained after trypsinization of thin skin biopsy resuspended into hyaluronic acid
16100922|NCT02156427|Device|PLACEBO|hyaluronic acid alone
16100923|NCT02156414|Procedure|Radical Prostatectomy|Radical Prostatectomy
16100924|NCT02156414|Procedure|Extended Lymphadenectomy|Extended Lymphadenectomy
16100925|NCT02156388|Biological|GW003|freeze-dried powder；single SC injection
16100926|NCT02156375|Drug|Ustekinumab|Participants will receive a single 6 milligram per kilogram (mg/kg) intravenous infusion of 90 milligram per milliliter (mg/mL) liquid in vial (LIV) formulation, diluted in saline, on Day 1.
16100927|NCT02156375|Drug|Ustekinumab|Participants will receive a single 6 mg/kg intravenous infusion of 5 mg/mL LIV formulation, diluted in saline, on Day 1.
16100928|NCT02156362|Other|follow up visit|At least 1 follow up visit per year will be done and an additional visit if needed.
16100929|NCT02156349|Device|Accu-Chek Smart Pix Software|Software with adherence evaluation software used according to Integrated Personalized Diabetes Management (PDM)
16100930|NCT02156349|Device|Accu-Chek Smart Pix readout Device|Smartpix device for data upload out of blood glucose meter devices
16100931|NCT02156336|Drug|Ranolazine|Oral administration, BID; for a maximum of 51 days.
16100932|NCT02156336|Drug|Placebo|Oral administration, BID; for a maximum of 51 days.
16100934|NCT02156323|Drug|RO7033877|Multiple doses of RO7033877 over 2.5 days
16100935|NCT02156323|Drug|RO7033877 + CMS|Multiple doses of RO7033877 and CMS over 2.5 days
16100936|NCT02156284|Behavioral|Empathic behaviour by nurses|"Control group: patients without specific empathic behaviour
~Intervention group: patients who received the empathic behaviour was performed by a trained nurse."
16100937|NCT02156271|Drug|ramelteon|
16100938|NCT02156271|Drug|placebo|
16100939|NCT02156258|Device|FFDM Mammography|Standard mammography image collection
16100940|NCT02156258|Device|DBT Mammography|Collection of breast images using DBT mammography
16100941|NCT02156245|Other|conventional rehabilitation program (including concentric cycle ergometer)|
16100942|NCT02156245|Other|cycling included into a conventional rehabilitation program|
16100943|NCT02156232|Procedure|TIPS|TIPS was performed in a conventional fashion or in combination of percutaneous transhepatic or transsplenic approach. TIPS revision was planned if any evidence of shunt dysfunction was seen.
16100944|NCT02156232|Procedure|embolization|Embolization of SPSS was conducted via the same jugular vein before TIPS implantation. The major procedures included (a)angiography of SPSS after successful intrahepatic puncture of a branch of the portal vein and (b)embolization of SPSS with coils of varying diameters, which resulted in the SPSS disappearing at postembolization angiography.
16100945|NCT02156219|Other|Separation of women and men in the metro of Mexico City|"The measure of separation between men and women exists in all modes of public transport in Mexico City (metro, metro-bus, trolley, bus and light rail), although it is not 100% implemented on all lines and in all hours. These differences in implementation schedule can be a way to identify a treatment group and a control group, and the fact that it has not been implanted in all lines/paths will allow to have a baseline.
~The implementation of the measure of separation of men and women on the subway consists of three operational tasks:
~Control: Surveillance that men do not use cars corresponding to women.
~Dosage: Regulation of entry women.
~Assignment: Of the women, to the part of the platform where the first wagons stop."
16100946|NCT02156206|Behavioral|123 women emergency phone line in Medellin, Colombia|"123 is the emergency number in Colombia. The 123- woman line consists of supplementary emergency services to meet the demands of urgency in relation to cases of VAW. This service is implemented by the mayor of Medellin, in collaboration with the national police who is the institution in charge of managing the 123 line.
~When the police attends an emergency on VCM, the call is derived to the 123- woman line. There, a team consisting of a psychologist and a lawyer serves women in crisis, as emergency services provided by the police are developed in parallel. The team verifies that the rights of women are respected and that women are oriented to the relevant services. The 123- woman line operates from 7:00 am to 7:00 pm, Monday through Friday."
16100947|NCT02156193|Procedure|Prophylactic clip|Prophylactic clipping
16100948|NCT02156193|Procedure|No prophylactic management|No prophylaxis
16100949|NCT02156167|Device|CP810 and Codacs™ system test|Nucleus® CP810 Sound Processor for the Codacs™ system (CE marked) and Codacs™ Test System (CE marked)
16100950|NCT02156154|Drug|Intravenous Acetaminophen|
16100951|NCT02156141|Other|Supervised high intensity training|8 weeks of supervised training
16100952|NCT02156141|Other|Optional training|8 weeks of optional training on cycle ergometer. No program needs to be followed. Participant decides whether they want to keep training or not.
16100953|NCT02156141|Other|Control period|8 weeks with no training.
16100954|NCT02156141|Other|Unsupervised High intensity training|8 weeks of unsupervised high intensity training.
16100955|NCT02156128|Behavioral|Cogmed working memory training|
16100956|NCT02156128|Behavioral|Control group|
16100957|NCT02156089|Other|Highly unsaturated omega-3 fatty acids|Nitrient - Matched Placebo of 3 g/d of macademia nut oil (in comparison to 3 g/d of omega-3 highly unsaturated fatty acids).
16100958|NCT02156076|Drug|BMS-919373|
16100959|NCT02156076|Drug|Placebo (Matching with BMS-919373)|
16100960|NCT02156063|Drug|NT100|
16100961|NCT02156063|Drug|Placebo|
16100962|NCT02156050|Device|two sessions of 4 hours Phototherapy treatment|two sessions of 4 hours Phototherapy treatment
16100963|NCT02156037|Behavioral|Diabetes Dashboard Intervention|The Diabetes Dashboard Intervention Condition involved a program of five, in-person, one-on-one diabetes education and behavior change visits with a diabetes nurse or diabetes dietician, scheduled at baseline, two weeks, one month, three months, and six months post-enrollment.
16100964|NCT02156037|Behavioral|Usual Diabetes Care|The UDC condition was delivered by four bicultural, bilingual diabetes nurses and diabetes dietitians who comprised the clinical site's long-standing, in-house diabetes program.
16100965|NCT02156024|Drug|Gastrodia and Uncaria Drink|Gastrodia and Uncaria Drink, 1 dose at a time, twice a day, duration: 4 weeks
16100966|NCT02155985|Drug|Aspirin|Aspirin is a nonsteroidal antiinflammatory drug (NSAID) effective in treating fever, pain, and inflammation in the body.
16100967|NCT02155985|Drug|Placebo|Placebo for aspirin
16100968|NCT02155972|Dietary Supplement|Bifidobacterium infantis|Probiotic supplement
16100969|NCT02155972|Other|Placebo|Placebo capsules
16100970|NCT02155959|Device|toric intraocular lens|toric intraocular lens
16100971|NCT02155946|Device|Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit|Active brain stimulation
16100972|NCT02155946|Device|Transcranial direct current stimulation (tDCS) Soterix Medical Inc. tDCS unit|Sham (placebo)
16100973|NCT02155933|Other|Blood sampling|Blood sampling for later hormone measurements
16100974|NCT02155920|Drug|Everolimus|The recommended dose of Everolimus is 4.5 mg/m2/dose, once daily for up to 2 years, until disease progression or unacceptable toxicity occurs.
16100975|NCT02155894|Behavioral|Disease control, Telemedicine, doctor|"Control of disease activity by a telemedicine consultation carried out by a doctor.
~The telemedicine consultation will be based on a telephone consultation, following a predefined consultation checklist.
~Patients who have expressed a desire to complete questionnaires in webform, will receive a letter a week before the consultation to remind them that they must assess their disease activity through the software interphase, within the next couple of days. Patients, who have expressed a wish to fill in questionnaires in paperform, will receive the questionnaire a week before the consultation.
~During telephone consultation, updated clinical test results will be available through the electronic medical system."
16100976|NCT02155894|Behavioral|Disease control, Telemedicine, nurse|"Control of disease activity by a telemedicine consultation carried out by a nurse.
~The telemedicine consultation will be based on a telephone consultation, following a predefined consultation checklist.
~Patients who have expressed a desire to complete questionnaires in webform, will receive a letter a week before the consultation to remind them that they must assess their disease activity through the software interphase, within the next couple of days. Patients, who have expressed a wish to fill in questionnaires in paperform, will receive the questionnaire a week before the consultation.
~During telephone consultation, updated clinical test results will be available through the electronic medical system."
16100977|NCT02155881|Drug|Ciclesonide|Ciclesonide nasal spray 50 mcg/actuation
16100978|NCT02155881|Drug|Ciclesonide Placebo|Ciclesonide placebo-matching nasal spray
16100979|NCT02155868|Other|Correction rSO2 desaturation.|"Predefined protocol of interventions for correcting rSO2 desaturation (< 60%) during cardiac surgery and the first six hours after it.
~In case of rSO2 decrease less than 60% correct:
~head position; position of aortic,venous cannulae and central venous catheters; partial pressure of carbon dioxide in arterial blood < 35 mmHg; mean arterial pressure < 60 mmHg; central venous pressure > 10 mmHg; cardiac index < 2.0 l/min/m2; mixed venous oxygen saturation < 60%; hemoglobin < 65 g/L during cardiopulmonary bypass or hemoglobin < 90 g/L after cardiopulmonary bypass; decrease cerebral O2 consumption."
16100980|NCT02155868|Other|Standard treatment|Standard treatment
16100981|NCT02155855|Other|Telemedicine|Study group will test blood glucose at least 4 times a day Each time the meter timestamps the reading. All meter readings will upload to the cloud via Myglucohealth website, where they can be accessed by caregivers, including providers and parents. Parents will be notified by device about the blood glucose testing results. Provider will set device to alert patient or patient's family or send alerts if uploaded numbers are outside an identified range (<70 mg/dL > 300 mg/dL). As per the standard of care, parents are trained to administer sugar containing liquids, or inject extra insulin for hyperglycemia correction. Parents will be encouraged to contact study personnel if they are concerned about the diabetes control. Study personnel will access home blood glucose monitor data, and provide insulin dosing advice. Parents will be asked to upload blood glucose readings prior to each visit.
16100982|NCT02155855|Other|Control|Routine care
16100983|NCT02155842|Behavioral|High intensity endurance exercise|
16100984|NCT02155842|Behavioral|Moderate continuous endurance exercise|
16100985|NCT02155829|Drug|Riluzole|
16100986|NCT02155829|Drug|Placebo (for Riluzole)|
16100987|NCT02155816|Dietary Supplement|Omega 7 + 3|Ingestion of omega 7 + 3 daily for 8 weeks.
16100988|NCT02155816|Dietary Supplement|Omega 3|Omega 3 daily for 8 weeks.
16100989|NCT02155816|Dietary Supplement|Placebo|Medium chain triglycerides
16100990|NCT02155803|Drug|ACTHAR Gel (adrenocorticotropic hormone)|ACTHAR GEL (adrenocorticotropic hormone) 80 units subcutaneously twice weekly for 12 weeks
16100991|NCT02155790|Device|The Peregrine System Infusion Catheter|The ASI catheter is inserted bilaterally into the renal arteries and a specified amount of a neurolytic agent is inserted into the vessel walls.
16100992|NCT02155777|Drug|OrthoNovum 1/35|
16100993|NCT02155764|Device|Octacalcium phosphate|Bone augmentation, after tooth extraction, with Octacalcium Phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.
16100994|NCT02155764|Device|Bio-Oss|Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide
16100995|NCT02155764|Device|Tricalcium phosphate|Bone augmentation, after tooth extraction, with Tricalcium Phosphate (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.
16100996|NCT02155751|Behavioral|Nutrition Lifestyle Intervention Program (NLIP)|The dietary program will mimic the gestational diabetic meal plan: a) individualize total energy intake with a minimum of 2000 kcal/day (8360 kJ/day), taking into account the usual energy intake as indicated by each dietary assessment (including 3-day food intake records) with a restriction of not more than 33% total energy intake; b) adjust if necessary the total carbohydrate intake to 40-50% of total energy intake, distributing carbohydrate intake throughout the day with three balanced meals, and three snacks per day emphasizing complex carbohydrates and low glycemic index foods; c) adjust the total fat intake to 30% of total energy intake (substituting monounsaturated fatty acids for saturated and trans-fatty acids), with the remaining 30% dedicated to protein intake; and d) meet all micronutrient and fluid needs recommended during pregnancy.
16100997|NCT02155751|Behavioral|Exercise Lifestyle Intervention Program (ELIP)|The exercise program includes a walking program in which pregnant women walk for 25 minutes, 3 to 4 times per week, adding 2 minutes each week, until 40 minutes is reached and then maintained until delivery. Each woman will be given a pedometer and log sheet to keep track of daily steps and to initiate self-monitoring behaviour.
16100998|NCT02155738|Drug|IV Acetaminophen|
16100999|NCT02155738|Drug|IV normal saline|IV normal saline
16101000|NCT02155725|Drug|Human Fibrinogen concentrate|Injection as soon as possible and within 30 min following the start of prostaglandin infusion
16101001|NCT02155725|Drug|Placebo|As soon as possible and within 30 min following the start of prostaglandin infusion
16101004|NCT02155699|Behavioral|Exercise 1|65% of VO2max and 2 sessions per week
16101005|NCT02155699|Behavioral|Exercise 2|85% intensity and 3 sessions per peek
16101006|NCT02155686|Device|Biosensors|Device: Biometric sensors; Home automation; telecare
16101007|NCT02155686|Device|Home automation|
16101008|NCT02155673|Drug|GCS-100|1.5 mg/m2 or 30 mg/m2 GCS-100. GCS-100 will be administered as IV infusions once weekly for 8 weeks with a 1 week and 4 week follow-up period and then at least every 30 days for up to a total of 1 year.
16101009|NCT02155660|Drug|Benralizumab Arm A|Benralizumab subcutaneously on study week 0 until study week 48 inclusive
16101010|NCT02155660|Drug|Benralizumab Arm B|Benralizumab subcutaneously on study week 0 until study week 48 inclusive
16101011|NCT02155660|Drug|Benralizumab Arm C|Benralizumab subcutaneously on study week 0 until study week 48 inclusive
16101012|NCT02155660|Drug|Placebo|Benralizumab subcutaneously on study week 0 until study week 48 inclusive
16101054|NCT02155335|Drug|Smartject Device delivery of Golimumab|Golimumab 50 mg solution for subcutaneous injection using Smartject Device.
16101013|NCT02155647|Drug|Avelumab|Avelumab was administered at a dose of 10 milligram per kilogram (mg/kg) as 1-hour intravenous infusion once every 2 weeks until therapeutic failure, significant clinical deterioration, unacceptable toxicity, or any criterion for withdrawal from the trial or investigational medicinal product occurs.
16101014|NCT02155634|Drug|Lenalidomide|Treatment with lenalidomide capsules 10 mg, 5mg daily or 5mg every other day given on days 1-21 of each 28 day cycle.
16101015|NCT02155621|Genetic|Genome sequencing|Subjects will have their cancers biopsied and blood samples taken; both will undergo genomic sequencing and analysis
16101016|NCT02155608|Device|Active eTNS|Participants will receive active trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks, followed by one week of observation and followup while remaining blinded following treatment discontinuation. Participant deemed to be positive responders to blinded active treatment will be invited to continue open eTNS in a 12 month extension period.
16101017|NCT02155608|Device|Sham eTNS|Participants will receive sham trigeminal nerve stimulation (TNS) administered by the Monarch eTNS System nightly during sleep for 4 weeks, followed by one week of observation and followup while remaining blinded following treatment discontinuation. At the conclusion of the blinded trial, participants randomized to the sham group will be offered 4 weeks of open eTNS treatment. Participants deemed to be positive responders to open treatment will be invited to continue open nightly eTNS in a 12 month extension period.
16101018|NCT02155595|Other|500 without BP treatment|lab tests, X-ray, bone scan or MRI, as needed
16101019|NCT02155595|Other|500 with BP treatment|lab tests, X-ray, bone scan or MRI, as needed (90 of these individuals can opt for iliac crest bone biopsy)
16101020|NCT02155582|Drug|Copanlisib (BAY80-6946)|0.8 mg/kg body weight and 0.4 mg/kg (not to exceed 65 mg) for the non-diabetic patients;45 mg and 60 mg for the diabetic patients; Intravenous (IV) infusion over 1 hour. Dosing of copanlisib will be on Days 1, 8, and 15 of each 28 day treatment cycle.
16101021|NCT02155569|Procedure|Extraperitoneal Cesarean|Pfannenstiel incision, paravesical approach to lower uterine segment extraperitoneally and Kerr incision for uterine entry
16101022|NCT02155569|Procedure|Transperitoneal Cesarean|Pfannenstiel-Kerr technique for laparatomy and uterine entry
16101023|NCT02155543|Drug|AGN-223575 Formulation A|One drop of AGN-223575 Formulation A administered in the study eye(s) per protocol.
16101024|NCT02155543|Drug|AGN-223575 Formulation B|One drop of AGN-223575 Formulation B in both eyes on day 1, followed by one drop of AGN-223575 Formulation B twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation B in both eyes on day 15.
16101025|NCT02155543|Drug|AGN-223575 Formulation C|One drop of AGN-223575 Formulation C in both eyes on day 1, followed by one drop of AGN-223575 Formulation C twice daily in both eyes for 13 days, and a single drop of AGN-223575 Formulation C in both eyes on day 15.
16101026|NCT02155543|Drug|AGN-223575 Vehicle|One drop of AGN-223575 vehicle administered in the study eye(s) per protocol.
16101027|NCT02155530|Drug|Atorvastatin 40mg|homogenous neointimal pattern at baseline OCT and randomized to atorvastatin 40 mg group
16101028|NCT02155530|Drug|pravastatin 20 mg|Intervention description : homogenous neointimal pattern at baseline OCT and randomized to pravastatin 20 mg group
16101029|NCT02155517|Drug|Evaluation of propofol effect|"The study will make in two stages:
~STAGE I: All volunteers will receive propofol infusion with the first model randomly chosen (Schnider or Cortinez) using TCI device, and the initial effect-site target concentration of propofol will be 3 ug/ml for 20 minutes."
16101030|NCT02155517|Drug|Evaluation of propofol effect|STAGE II: 72 hours after stage I . All volunteers will receive propofol infusion with the first model randomly chosen (Schnider or Cortinez) using TCI devices, and the initial effect-site target concentration of propofol will be 3 ug/ml for 20 minutes.
16101031|NCT02155504|Drug|ASP3700|oral
16101032|NCT02155504|Drug|itraconazole|oral
16101033|NCT02155504|Drug|Placebo|oral
16101034|NCT02155478|Device|ISERT 250 (HOYA, Japan): a standard IOL|
16101035|NCT02155478|Device|AMO ZCB00 IOL (Abbott Medical Optics, United States): a standard IOL|
16101036|NCT02155465|Drug|Ruxolitinib|"Ruxolitinib 10mg PO BID
~Ruxolitinib 15mg PO BID
~Ruxolitinib 20mg PO BID"
16101037|NCT02155465|Drug|Erlotinib|Erlotinib 150mg PO QD
16101038|NCT02155452|Procedure|ALA Test group|"Prior to surgery all patients would receive freshly prepared solution of 5-ALA, 20 mg/kg bodyweight dissolved in 100 ml of potable water orally approximately 4 hours (range 4-6 hrs) before the commencement of anesthesia induction for surgery.
~The surgery would then be performed with the help of navigation. After craniotomy, the navigation software would be used to identify the selected target areas based on the preoperative images (MR as well as PET when available) and directed image-guided biopsies from these representative areas will be collected for histological evaluation"
16101039|NCT02155439|Drug|5-fluorouracil|antimitotic drug
16101040|NCT02155439|Drug|Triamcinolone|
16101041|NCT02155400|Device|Bair Hugger|Forced Air Warming Blanket placed over the body of the patient during surgery
16101042|NCT02155400|Device|Prototype / Experimental device|Contact heating device provides heat to the sole of the foot and popliteal fossa while providing intermittent compression to the lower leg.
16101043|NCT02155374|Drug|Sliding scale insulin|
16101044|NCT02155374|Drug|Intermediate acting insulin|
16101045|NCT02155374|Behavioral|Dietary advice|Dietary advice to avoid food products with high glycemic index / high glucose load
16101046|NCT02155374|Drug|Glucose lowering medication|Regular glucose lowering medication as prescribed by the patient's own physician before study entry
16101047|NCT02155374|Drug|Chemotherapy|Chemotherapy (containing glucocorticoids) as prescribed by the patient's own physician
16101048|NCT02155361|Drug|Topical Citrullus colocynthis fruit oil (1%)|
16101049|NCT02155361|Drug|Topical vehicle oil|
16101050|NCT02155348|Procedure|Bilateral cataract surgery with implantation of multifocal IOLs|Lentis LS-313, multifocal, target refraction of the distance-dominant eye: 0.00D, target refraction of the other eye: -0.50D
16101051|NCT02155348|Procedure|Bilateral cataract surgery with monovision|Lentis L-313, monofocal, target refraction of the distance-dominant eye: 0.00D to -0.25D, target refraction of the other eye: -1.50D
16101052|NCT02155348|Device|Lentis LS-313|
16101053|NCT02155335|Drug|Prefilled Syringe delivery of Golimumab|Golimumab 50 mg solution for subcutaneous injection using prefilled syringe
16101055|NCT02155322|Biological|Pegylated Interferon Alfa-2b|6 μg/kg, weekly dosing, subcutaneous administration, Induction Phase - first 8 weeks
16101056|NCT02155322|Biological|Pegylated Interferon Alfa-2b|3 μg/kg SC once weekly for a 42-week maintenance phase (for a total treatment of up to approximately 1 year)
16101057|NCT02155309|Drug|Scopolamine|
16101058|NCT02155309|Drug|Placebo|
16101059|NCT02155296|Behavioral|Restorative Practices Intervention|"RPI has the 3 core components of an optimal comprehensive positive youth development intervention:
~(1) sustained relationships with adults-RPI creates positive and sustained adult-youth relationships through teacher-student dialogue that occurs in circles; (2) skills building-RPI uses teachers and other school staff to coach students on 7 of the 11 essential practices; and (3) application of skills building-As students develop proficiency in the 7 essential practices they are coached to perform, school staff transfer responsibility for running the circles over to students. Restorative conferences for serious and or chronic behavior problems are the only circles that teachers continue to facilitate. Quasi-experimental studies have shown that schools implementing RPI have reductions in disciplinary referrals and school suspension."
16101060|NCT02155283|Device|Continuous Passive Motion|Daily self-treatments at home for 3 weeks, with up to three 10-minute treatment sessions per day
16101061|NCT02155270|Procedure|Corneal precut 600µm|
16101062|NCT02155270|Procedure|Corneal stabincision|
16101063|NCT02155257|Drug|Modafinil|
16101064|NCT02155257|Drug|Gabapentin|
16101065|NCT02155257|Drug|Placebo|
16101066|NCT02155218|Other|Standard Injection Rate|Normally an IV is placed in an arm and the gadolinium contrast (30-40 cc, depending on patient size) is administered through the IV with a power injector as a single bolus. Subjects will have a test bolus and main bolus.
16101067|NCT02155218|Other|Patient Tailored Injection Rate|"Normally an IV is placed in an arm and the gadolinium contrast (30-40 cc, depending on patient size) is administered through the IV with a power injector as a single bolus. Subjects will have a test bolus and main bolus. We will use a mathematical algorithm to rapidly analyze the test bolus and calculate a predicted best way to inject the main bolus - likely slower and multi-phasic, meaning different flow rates as the bolus injection evolves."
16101068|NCT02155218|Other|gadolinium contrast|
16101069|NCT02155205|Drug|Telotristat etiprate|1500 mg telotristat etiprate (six 250 mg tablets)
16101070|NCT02155205|Drug|Placebo|Matching placebo
16101071|NCT02155205|Drug|Moxifloxacin|400 mg moxifloxacin (one 400 mg tablet)
16101072|NCT02155192|Drug|No Intervention|
16101073|NCT02155166|Drug|Intracervical anesthesia with lidocaine 2%|5 min before LNG-IUS placemen
16101074|NCT02155166|Drug|ibuprofen 400 mg|1 hour prior to the LNG-IUS insertion
16101075|NCT02155153|Other|Sugar Free Chewing Gum|'Extra' sugar free gum will be used as an intervention. Patients will be required to chew a gum for 30 min at intervals of 6 hours for first 48 hours post operatively or until they pass flatus.
16101076|NCT02155140|Dietary Supplement|Jejunal feeding|A feeding jejunostomy tube is inserted at the time of surgery to provide enteral nutritional support.
16101077|NCT02155127|Behavioral|walking|
16101078|NCT02155101|Drug|Darunavir|Darunavir (PREZISTA) is a film coated, oval shaped, light orange 19.1mm tablet, debossed with 400 mg on one side and TMC on the other side.
16101079|NCT02155101|Drug|ART with 2 NRTIs plus LPV/r (or ATV/r)|Patients on second line antiretroviral therapy take 2 NRTIs and either protease inhibitor lopinavir/ritonavir or atazanavir/ritonavir.
16101080|NCT02155088|Drug|BYL719|Dose escalation beginning at 250 mg/day
16101081|NCT02155088|Drug|Gemcitabine|Dose escalation beginning at 800 mg/m^2
16101082|NCT02155088|Drug|(nab)-paclitaxel|125 mg/m^2 dose
16101083|NCT02155075|Device|MIRA device imaging|MIRA device imaging for adjunctive detection of breast cancer. Arm 1 administarte result
16101084|NCT02155062|Other|Whole grain rye|
16101085|NCT02155062|Other|Whole grain wheat|
16101086|NCT02155062|Other|Refined cereal|
16101087|NCT02155049|Drug|bimatoprost 0.03%|The patients will receive a single daily drop of bimatoprost for six months.
16101088|NCT02155036|Other|Exercise|The intervention will include 2 sessions of gym-based exercise per week, both of which will be supervised for 3 months, supervision will then decrease to once-weekly until 6 months, and then be through phone support for the remaining 6 months. Warm up and cool down of minimum of five minutes on stationary exercise cycle, rate of perceived exertion (RPE) ~11, followed by gentle stretching. Progressive resistance training (PRT) will use eight PRT machines training large muscle groups (e.g. bench press, latissimus pulldown, bicep curl, triceps pull down, leg press, knee extension, hamstring curl, calf raises). Intensity will be 80% of one repetition maximum (1RM), building up to 3 sets of 8 repetitions. 1RM will be re-assessed monthly, and program adjusted accordingly.
16101089|NCT02155023|Drug|Insulin dosing|
16101090|NCT02155023|Device|Glucose sensors IR-Glucose Reader (Joanneum Research, Austria), IR-CGM (IMM, Germany)|
16101091|NCT02155010|Drug|Dexmedetomidine|Dexmedetomidine infusion before intrathecal injection of heavy bupivacaine
16101092|NCT02155010|Drug|Dexmedetomidine with heavy bupivacaine|Dexmedetomidine infusion after IT of heavy bupivacaine
16101093|NCT02154984|Behavioral|behavioral dietary intervention|Follow tRD
16101094|NCT02154984|Behavioral|telephone-based intervention|Receive coaching calls
16101095|NCT02154984|Other|laboratory biomarker analysis|Correlative studies
16101096|NCT02154932|Drug|2 doses 400 microgram misoprostol|2 doses 400 microgram misoprostol, 3 and 1 hours
16101097|NCT02154932|Drug|single dose misoprostol|1 dose, 1 hours, prior surgery
16101098|NCT02154919|Procedure|Percutaneous coronary intervention|
16101099|NCT02154906|Device|DFDBA|
16101100|NCT02154906|Device|autologous platelet rich fibrin|
16101101|NCT02154893|Device|Ultrasound plus Laser and therapeutic exercise|Ultrasound with frequency 1 Mhz and infrared laser with output power at 100 mW. The resistance training was performed.The treatments are done once a week, for 3 months.
16101102|NCT02154893|Device|Ultrasound plus Laser|Ultrasound with frequency 1 Mhz and infrared laser with output power at 100 mW. The treatments are done once a week, for 3 months.
16101103|NCT02154893|Device|Utrasound plus Laser Placebo|The device with Ultrasound and infrared laser without emitting electromagnetic or mechanical waves was applied (null dose).
16101169|NCT02154477|Drug|placebo (intranasal saline)|saline
16101104|NCT02154880|Procedure|PFT|Lung function endpoints of FVC, FEV1, FEV1/FVC, and FEF25-75% will be measured with the flow-volume loop recorder on a NDD EasyOne Pro system before and after bronchodilator administration.
16101105|NCT02154880|Procedure|lab work|The blood will be processed for serum, plasma, and PBMCS, and a portion stored to be used for future use. A hemoglobin and Carboxyhemoglobin will be done in order to calculate the DLCO.
16101106|NCT02154880|Procedure|6MWT|The six-minute walk tests are performed in a 100-foot segment of straight hallway marked at 1-foot intervals.
16101107|NCT02154880|Other|questionnaires|TEAL, MMRC and ST. George's Questionnaire will be administered. They are paper questionnaires that inquire about respiratory symptoms, quality of life, smoking history and other health issues
16101108|NCT02154867|Biological|Fecal transplantation|Preparation of flesh feces by blending in 0.9 % saline and crude filtering. The solution is applied in proximal colon of IBS patient by colonoscopy after standard bowel preparation.
16101109|NCT02154867|Other|Placebo fecal transplant|Fecal transplantation with own feces
16101110|NCT02154854|Drug|Tacrolimus targeted half-dose|
16101111|NCT02154854|Drug|Tacrolimus targeted plain dose|
16101112|NCT02154841|Behavioral|Questionnaire, taste test, visual food test|
16101113|NCT02154828|Behavioral|Integrative practices|
16101114|NCT02154815|Other|Questionnaires : Patient-Reported Outcomes|Patient-Reported Outcomes completion every six months prior to surgery, at hospital discharge, and at 3, 6,12, and 24 months
16101115|NCT02154802|Behavioral|video: community member|
16101116|NCT02154802|Behavioral|video: physician|
16101117|NCT02154802|Behavioral|video: choice of video|
16101118|NCT02154789|Drug|polidocanol|
16101119|NCT02154789|Procedure|infra-red coagulation|
16101120|NCT02154789|Procedure|cryotherapy|
16101121|NCT02154776|Drug|LEE011|3 weeks on and 1 week off
16101122|NCT02154776|Drug|Buparlisib|daily
16101123|NCT02154776|Drug|Letrozole|2.5 mg daily;
16101124|NCT02154763|Drug|Ropivacaine|
16101125|NCT02154763|Drug|Normal Saline|
16101126|NCT02154750|Device|Long, fixed AV delay|Pacemaker will be set to a long, fixed AV delay to minimize ventricular pacing
16101127|NCT02154750|Device|Short, optimized AV delay|Pacemaker will be set to the AV delay that produces the greatest cardiac output in echocardiography for each patient enrolled.
16101128|NCT02154737|Drug|Gemcitabine|Gemcitabine will be administered intravenously at 1000 mg/m2 on Days 1, 8, and 15 of a 28-day cycle.
16101129|NCT02154737|Drug|Erlotinib|Erlotinib will be administered orally on Days 2-4 and Days 16-18 of a 28-day cycle in serial cohorts with doses of 750mg, 1000mg, 1250mg, 1500mg, 1750mg, and 2000mg.
16101130|NCT02154724|Device|aDBS|The aDBS is applied for 2 hours for two days with two different modalities (aDBS and DBS) in random order.
16101131|NCT02154724|Device|DBS|The aDBS s applied for two hous in DBS modality.
16101132|NCT02154698|Other|22-gauge Standard Needle|Acquisition of lymph nodes samples using the 22-gauge Standard Needle, following subject-sedation and the introduction of an EBUS scope into the airway.
16101133|NCT02154698|Other|22-gauge ProCore Needle|Acquisition of lymph nodes samples using the 22-gauge ProCore Needle, following subject-sedation and the introduction of an EBUS scope into the airway.
16101134|NCT02154685|Behavioral|Retrieval-Extinction|A relatively brief exposure to cues prior to conducting more protracted cue exposure. This is referred to as retrieval-extinction training.
16101135|NCT02154685|Behavioral|Non-Retrieval Extinction|Neutral cue exposure.
16101136|NCT02154659|Device|24hr pH monitoring|
16101137|NCT02154646|Drug|LY2157299|Administered orally
16101138|NCT02154646|Drug|Gemcitabine|Administered IV
16101139|NCT02154633|Behavioral|Family Gene Toolkit|Psychosocial educational presentations over the Internet (Webinars) Two Webinars lasting 1 hour each One follow-up phone call lasting 20 minutes Webinars and phone calls are delivered to one mutation carrier and one non-tested relative Genetic counselors and nurses with master's degree and experienced in oncology deliver the content of the intervention
16101140|NCT02154633|Behavioral|Delayed Family Gene Toolkit|Psychosocial educational presentations over the Internet (Webinars) Two Webinars lasting 1 hour each One follow-up phone call lasting 20 minutes Webinars and phone calls are delivered to one mutation carrier and one non-tested relative Genetic counselors and nurses with master's degree and experienced in oncology deliver the content of the intervention
16101141|NCT02154620|Procedure|Volar plate|An anatomically countoured volar plate is implanted through a Henry's incision.
16101142|NCT02154620|Device|Synthes TCP volar plate|
16101143|NCT02154607|Device|CO2-Laser Treatment|
16101144|NCT02154594|Drug|Acacia catechu|
16101145|NCT02154594|Drug|Chlorhexidine gluconate|
16101146|NCT02154594|Other|Distilled water|
16101147|NCT02154581|Device|SLActive implant|
16101148|NCT02154568|Drug|hyperpolarized helium MRI of the chest|Using hyperpolarized helium as an inhaled gaseous contrast agent for MRI, we will measure the velocity of inhaled breath in the trachea.
16101149|NCT02154555|Procedure|debridement|post-operative debridement at 1 week follow-up visit
16101150|NCT02154542|Device|Neurovent Monitor XIII|
16101151|NCT02154529|Drug|Tesevatinib|
16101152|NCT02154529|Drug|Trastuzumab|
16101153|NCT02154516|Device|ODH Hip System|
16101154|NCT02154503|Device|topical 5% Minoxidil (Microneedling)|
16101155|NCT02154490|Drug|Docetaxel|Given IV
16101156|NCT02154490|Biological|Durvalumab|Given IV
16101157|NCT02154490|Drug|Erlotinib Hydrochloride|Given PO
16101158|NCT02154490|Drug|FGFR Inhibitor AZD4547|Given PO
16101159|NCT02154490|Biological|Ipilimumab|Given IV
16101160|NCT02154490|Other|Laboratory Biomarker Analysis|Correlative studies
16101161|NCT02154490|Biological|Nivolumab|Given IV
16101162|NCT02154490|Drug|Palbociclib|Given PO
16101163|NCT02154490|Other|Pharmacological Study|Correlative studies
16101164|NCT02154490|Biological|Rilotumumab|Given IV
16101165|NCT02154490|Drug|Talazoparib|Given PO
16101166|NCT02154490|Drug|Taselisib|Given PO
16101167|NCT02154490|Biological|Tremelimumab|Given IV
16101168|NCT02154477|Drug|intranasal insulin|insulin
16101173|NCT02154438|Drug|Ketamine|ketamine 0.5mg/kg loading followed by 0.5mg/kg/h infusion during operation
16101174|NCT02154425|Procedure|Breast milk sampling|Pharmacokinetic (PK) samples will be taken from breast milk of lactating mothers on an established dosing regimen of CZP on Day 0 of the Sampling Period, just prior to next scheduled dose of CZP, and on Days 2, 4, 6, 8, 10, 12, and 14 (pre-dose for mothers on CZP Q2W), relative to CZP administration on Day 0. In addition, in mothers on a CZP Q4W dosing regimen, the concentration of CZP in breast milk will also be evaluated on or about Day 28 (i.e., prior to and on the same day of the next scheduled administration of CZP).
16101175|NCT02154425|Biological|Certolizumab Pegol|Mothers who decided to continue on, or to start treatment with, Certolizumab Pegol (CZP) for an approved indication with their treating physician prior to participation into this study. The mother is responsible for procuring her own supply of commercial CZP. The CZP dose and administration schedule will be as per the locally approved label.
16101176|NCT02154412|Other|Respiratory Training|Assembled together using a T-shaped connector, a threshold Positive Expiratory Pressure Device (Respironics, Inc.) & an Inspiratory Muscle Trainer (IMT, Respironics Inc.) with mouthpiece will be used. During inhalation, the subjects will initiate each breath from residual volume (RV) and to sustain the effort until their lungs feel full. During exhalation, the subjects will breathe from total lung capacity and sustain their effort until their lungs feel empty. Participants will be asked to train 45 minutes per day, 5 days per week, for 4 weeks. The training will be initiated with a load equal to 20% of their individual PImax and PEmax with progressive increases as tolerated up to 40% of their baseline PImax or PEmax.
16101177|NCT02154399|Drug|EF5|Given IV
16101178|NCT02154399|Other|Laboratory Biomarker Analysis|Correlative studies
16101179|NCT02154399|Procedure|Therapeutic Conventional Surgery|Undergo surgery/thoracotomy
16101180|NCT02154399|Other|Tissue Oxygen Measurement|Undergo tumor hypoxia measurement
16101181|NCT02154386|Device|Ridge preservation using DFDBA|tooth extraction followed by ridge preservation grafting using DFDBA
16101182|NCT02154360|Drug|Aprepitant|Subjects will add 375 mg daily dosing of aprepitant (Emend®) to their current antiretroviral therapy for 28 days
16101183|NCT02154347|Drug|KAD-1229|
16101184|NCT02154347|Drug|Placebo|
16101185|NCT02154347|Drug|Insulin|
16101186|NCT02154334|Drug|Esketamine|Participants will self-administer one Intranasal spray of 14 mg esketamine solution in each nostril on Day 1 at time 0 and 5 minutes (total esketamine dose will be 56 mg) in Period 1 and Period 2.
16101187|NCT02154334|Drug|Mometasone|Healthy participants will self-administer 2 intranasal sprays of 50 mcg mometasone suspension in each nostril for a total dose of 200 mcg on days 1 to 15 and 2 intranasal sprays of 50 mcg mometasone suspension in each nostril prior to 1 intranasal spray of esketamine solution 14 mg in each nostril at Time 0 and 5 minutes for a total dose of 56 mg on Day 16 in Period 2.
16101188|NCT02154334|Drug|Oxymetazoline|Nasal rhinitis participants will self-administer 2 intranasal sprays of Oxymetazoline 0.05% w/v solution in each nostril at time -1 hour before administration of 1 Intranasal spray of 14 mg esketamine solution in each nostril at time 0 and 5 minutes, for a total dose of 56 mg in Period 1or Period 2.
16101189|NCT02154321|Device|Electroencephalogram (EEG)|The electroencephalogram assesses brain electrical activity through surface recording disks (electrodes) which are placed near the participants' head using a custom designed Lycra cap. The electrodes transmit the signals which are then amplified and stored on a computer. The procedure is entirely non-invasive. Once an accurate signal is assured, the signal derived from the electrode cap is then amplified, transmitted to a computer, and stored for later analysis. Each participant will undergo the electroencephalogram (EEG) procedure only once for the duration of 30-45 minutes.
16101190|NCT02154308|Biological|IL-YANG FLU Vaccine Prefilled Syringe INJ 0.5mL|IL-YANG FLU Vaccine Prefilled Syringe INJ 0.5mL by intramuscular injection
16101191|NCT02154295|Device|Infraredx Test Catheter|
16101192|NCT02154282|Behavioral|ipod games|Patients will be given ipod games for 4 weeks and tested in related and unrelated cognitive measures
16101193|NCT02154269|Drug|Treatment with G-CSF (Granulocyte colony stimulating factor)|Subjects will be randomly assigned to receive treatment with G-CSF (10mg/kg/day) for five days, during 4 cicles.
16101194|NCT02154269|Drug|Placebo saline|Subjects will be randomly assigned to receive treatment saline for five days, during 4 cicles.
16101195|NCT02154256|Behavioral|Increasing incentives|Offer incentives that increase over time.
16101196|NCT02154256|Behavioral|Decreasing incentives|offer incentives that decrease over time
16101197|NCT02154256|Behavioral|stable incentives|offer incentives that are stable over time, but higher than usual care
16101198|NCT02154243|Drug|Midodrine|10 mg, p.o., once, on day of surgery after first physical therapy session
16101199|NCT02154243|Other|Intravenous fluid bolus|15 cc/kg, once, on day of surgery after first physical therapy session
16101200|NCT02154230|Dietary Supplement|"Acqua Santa di Chianciano® (sulphate-bicarbonate-calcium water)"|"During the first 4 weeks the SW-D patients will be asked to drink every morning, before breakfast, within 30 minutes, 500 mL of Acqua Santa di Chianciano® at room temperature."
16101201|NCT02154230|Dietary Supplement|Tap water|During the first 4 weeks the TW-D patients will be asked to drink every morning, before breakfast, within 30 minutes, 500 mL of tap water at room temperature.
16101202|NCT02154217|Drug|Bimatoprost|
16101203|NCT02154217|Drug|Latanoprost/Timolol|
16101204|NCT02154191|Procedure|Surgical Intervention|The clinical intervention in this study is the routine surgical procedures taken for patients requiring surgery for degenerative lumbar spinal stenosis.
16101205|NCT02154178|Other|Biomarker group|use of invasive fungal disease biomarkers (β-1,3-glucan, mannan/anti-mannan antibodies)
16101206|NCT02154165|Other|Phototherapy|The infants were randomized to phototherapy with either blue og turquoise light
16101207|NCT02154152|Drug|Homoeopathic Medicine causticum 200c|
16101208|NCT02154139|Drug|Leuprorelin acetate|Leuprorelin acetate SR 11.25 mg for injection
16101209|NCT02154126|Device|Continuous Glucose Monitoring Device (Senseonics)|
16101210|NCT02154113|Device|Ultrashape|All subjects receive 3 successive Ultrashape treatments every two weeks in the anterior abdomen.
16101211|NCT02154113|Device|Velashape II|All subjects receive 3 successive Velashape treatments every two weeks in the anterior abdomen.
16101295|NCT02153502|Drug|Placebo|Placebo capsules administered twice a day over a 10-week period
16101212|NCT02154100|Dietary Supplement|Tart Cherry|12 weeks of tart cherry juice taken in two doses of 240 ml per day.
16101213|NCT02154100|Dietary Supplement|Placebo|12 weeks of tart cherry juice taken in two doses of 240 ml per day.
16101214|NCT02154087|Biological|HP802-247|260 µL (130 µL, one spray, of each component) containing 0.5 x 10.6 cells per mL, alternating weekly with Vehicle
16101215|NCT02154074|Drug|general anesthesia induction|general anesthesia induction: midazolam 0.1mg/Kg, sufentanil 1ug/Kg, cisatracurium 0.15mg/Kg, and then immediatly administrate etomidate 0.2 mg/Kg
16101216|NCT02154074|Drug|Isoflurane|inhale Isoflurane 1.5MAC
16101217|NCT02154074|Drug|Dexmedetomidine|anesthesia induction period: intravenous pumping Dexmedetomidine 4ug/Kg/h; after 10 minutes,turn to 0.4ug/Kg/h.
16101218|NCT02154074|Drug|normal saline|the same volume of saline + Isoflurane during operation
16101219|NCT02154061|Drug|IIV Flu Vaccine|This is an FDA approved and tested Inactivated Flu Vaccine.
16101220|NCT02154061|Drug|Metronidazole|This is a standard antibiotic
16101221|NCT02154061|Drug|Neomycin|This is a standard antibiotic.
16101222|NCT02154061|Drug|Vancomycin|This is a standard antibiotic.
16101223|NCT02154048|Drug|Ropivacaine|
16101224|NCT02154048|Drug|Dexamethasone|
16101225|NCT02154048|Other|Placebo|
16101226|NCT02153983|Drug|Colchicine 0.6Mg Cap|Colchicine 0.6 mg given twice daily
16101227|NCT02153983|Drug|Placebo capsules given|Placebo capsules given twice daily
16101228|NCT02153983|Drug|Colchicine 0.6Mg Tab|Open-label colchicine
16101230|NCT02153944|Drug|Propanolol|placebo to be given during study visit
16101231|NCT02153944|Drug|Methylphenidate|60mg during study visit
16101232|NCT02153918|Biological|PROSTVAC-V/TRICOM|A recombinant vaccinia virus vector vaccine containing the genes for human prostatic specific antigen (PSA) and three co-stimulatory molecules.
16101233|NCT02153918|Biological|PROSTVAC-F/TRICOM|A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.
16101234|NCT02153905|Drug|Aldesleukin|Aldeskeukin 720,000 IU/kg (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).
16101235|NCT02153905|Drug|Fludarabine|Days -7 to -3: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
16101236|NCT02153905|Drug|Cyclophosphamide|Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
16101237|NCT02153905|Biological|Anti-MAGE-A3 human leukocyte antigen serotype within HLA-A A serotype group (HLA-A* 01)-restricted T-cell receptor (TCR)|Day 0: MAGE-A3-A1 transduced peripheral blood lymphocytes (PBL) will be infused intravenously on the Patient Care Unit over 20-30 minutes.
16101238|NCT02153892|Device|GDS Accucinch System|Percutaneous Coronary Intervention
16101239|NCT02153879|Drug|Fenofibrate|fenofibrate 145/day for 12 weeks
16101240|NCT02153879|Drug|Niacin plus laropiprant|Niacin 2 g/day plus Laropiprant for 12 weeks
16101241|NCT02153866|Biological|rotavirus vaccine|3ml/dose, oral
16101242|NCT02153866|Biological|measles-rubella vaccine|0.5ml per dose, subcutaneous injection
16101243|NCT02153866|Biological|measles-mumps-rubella vaccine|0.5ml per dose, subcutaneous injection
16101244|NCT02153840|Drug|PSORI-CM01（YXBCM01） granule|
16101245|NCT02153840|Drug|placebo|
16101246|NCT02153827|Other|Eccentric Shoulder External Rotator Training|Eccentric training exercise for the external rotators, 3 sets of 15 daily.
16101247|NCT02153827|Other|General Shoulder exercise|general exercise consisting of active shoulder movements
16101248|NCT02153814|Procedure|Endometrial Scratch|After cleansing the cervix with Betadine, the procedure will be performed using a 3mm endometrial sampling curette, with three passes made of the endometrium along the length of the fundus. Patients will be given the option to take ibuprofen 600mg one hour prior to the scheduled procedure. The first endometrial scratch procedure or sham procedure will be performed up to two weeks prior to expected menses, and the second endometrial scratch or sham procedure will be performed cycle day 5-11 of the stimulation cycle.
16101249|NCT02153814|Procedure|Sham procedure|For the sham procedure, after cleansing the cervix with betadine, the endometrial sampling curette will be placed 2-3cm into the cervix without entering the uterine cavity
16101250|NCT02153801|Procedure|During the surgical procedure of Laparoscopic Low Anterior Resection with Total mesorectal Excision .|"For High Ligation The opening of the peritoneum proceeds cephalad towards the duodenojejunal angle of Treitz, and the mesenteric root is incised 1 cm below the inferior margin of the pancreas. The aortomesenteric window is opened wide and the inferior mesenteric vessels are exposed. The inferior mesenteric artery (IMA) is ligated and divided at 2 cm from its origin. The inferior mesenteric vein is ligated and divided below the pancreatic margin.
~For Low Ligation The opening of peritoneum proceeds upward and then laterally towards the sigmoid colon. Left colic artery is identified and preserved while low ligation of the inferior mesenteric artery (superior hemorrhoidal artery) is performed. Lymphadenectomy is carried on medially along the inferior mesenteric artery until 2 cm from the aorta.
~For both groups dissection is then carried on windowing Toldt and Gerota fascias till the parietocolic gutter."
16101251|NCT02153788|Drug|Temazepam|Temazepam 15 mg orally at bedtime
16101252|NCT02153788|Drug|Placebo|
16101253|NCT02153775|Behavioral|Progressive Muscle Relaxation|Comparison of progressive muscle relaxation and no intervention (e.g., reading newspaper of the day) for the same amount of time.
16101254|NCT02153762|Drug|Locoid Lipocream|Patients were randomized to apply Locoid Lipocream followed by Hylatopic Plus lotion on either the right or left side target lesion with the reverse order on the other side.
16101255|NCT02153762|Drug|Hylatopic Plus|Patients were randomized to apply Locoid Lipocream followed by Hylatopic Plus lotion on either the right or left side target lesion with the reverse order on the other side.
16101296|NCT02153489|Drug|Aclidinium bromide|
16101297|NCT02153489|Drug|Placebo|
16101298|NCT02153476|Drug|2.0mg of ALG-1001|
16101299|NCT02153476|Drug|Balanced Salt Solution|
16101300|NCT02153463|Behavioral|Physical Activity Counselling|Physical Activity Counselling weekly for 8 weeks
16101256|NCT02153749|Behavioral|Cognitive Regulation of Craving|"Regulation strategy practice: Participants will be trained to use a CBT-based cognitive regulation strategy. They will be asked to think of their individualized negative consequences for and thing of them when they see the instruction LATER during the task. Participants will practice using this strategy for multiple cigarette stimuli. High-Risk Situation Practice: Participants will identify 10 situations in which they usually smoke, or are likely to smoke in the next 48 hours. For each situation, they will be asked to practice using the strategy and to plan to use this strategy to regulate craving in daily life."
16101257|NCT02153749|Behavioral|Mindfulness-Based Regulation of Craving|"Each training session in this condition will be identical to the CBT-based training session described, with the exception of the strategy being trained. Specifically, participants will be trained in using the MBT-based strategy (notice craving and accept the feeling without judgment or reaction). To do so, they will be asked to generate their own non- reactive responses to craving (e.g., I can just sit here and notice this. I can ask myself, 'can I be ok with this feeling?') Participants will then be instructed to think of those accepting and non-reactive responses when they see the instruction ACCEPT during the task. All other components will be identical."
16101258|NCT02153736|Behavioral|SPEEDI Intervention|Behavioral intervention provided through a collaboration between the mother of enrolled subjects and a physical therapist. Intervention starts in the Neonatal Intensive Care Unit and continues after discharge. SPEEDI includes both parent education and developmental activities.
16101259|NCT02153723|Drug|Glatiramer Acetate|
16101260|NCT02153710|Behavioral|Semantic Feature Analysis therapy|Control therapy; current standard of care therapy
16101261|NCT02153710|Behavioral|Phonomotor Therapy|Experimental therapy.
16101262|NCT02153697|Device|Q-switched SINON Ruby Laser|Solar lentigines on the right back of the hand side are treated with the Q-switched SINON Ruby Laser at Baseline and if required at day 28.
16101263|NCT02153697|Drug|Pigmanorm Cream|Solar lentigines on the left back of the hand side are treated once a day during 7 weeks with Pigmanorm cream, a bleaching cream containing hydrochinon.
16101264|NCT02153671|Biological|A(H5N1) inactivated influenza vaccine (IIV)|Prepared from the NIBRG-23 vaccine virus strain. One vaccine dose (0.5 ml) contained 15 mg of influenza A(H5N1) virus hemagglutinin (HA), adjuvanted with aluminum hydroxide. Two doses were administered intramuscularly 28 days apart.
16101265|NCT02153671|Biological|A(H5N2) live attenuated influenza vaccine (LAIV)|Two doses of A(H5N2) live attenuated influenza vaccine (LAIV) administered 28 days apart, approximately 1.5 years prior to receiving A(H5N1) IIV
16101266|NCT02153658|Procedure|Subjects cleaned the foreskin with soapy water using a syringe once a day.|
16101267|NCT02153658|Procedure|Subjects cleaned the foreskin with diluted chlorhexidine (1%) using a syringe once a day.|
16101268|NCT02153645|Drug|240mg Amantadine HCl ER tablets|
16101269|NCT02153645|Drug|Placebo tablets|
16101270|NCT02153645|Drug|320mg Amantadine HCl ER tablets|
16101271|NCT02153632|Drug|amantadine HCl ER|Subjects are given either 240 mg amantadine HCl ER tablet or 320 mg amantadine HCl ER tablet
16101272|NCT02153632|Drug|Placebo|subjects are given an identical placebo tablet
16101273|NCT02153619|Behavioral|Meaning-Centered Grief Therapy (MCGT)|MCGT is a manualized, one-on-one intervention that uses psychoeducation, experiential exercises, and homework focusing on themes related to meaning, identity, purpose, and legacy. Post-intervention qualitative exit interviews will assess acceptability of the MCGT intervention (see Appendix I). Participants randomized to MCGT will provide their feedback about MCGT and the measures (n = 33).
16101274|NCT02153619|Behavioral|Supportive Psychotherapy (SP)|"SP is the comparison condition in this study and is a standardized, manualized intervention developed by the MSK Psychiatry Service and utilized in our completed and ongoing RCTs of Meaning-Centered Psychotherapy."
16101275|NCT02153619|Behavioral|questionnaires assessments|
16101276|NCT02153606|Drug|Glycerin Suppository|The treatment intervention will be a 250 mg glycerin suppository placed in the rectum once daily starting 48-72 hours after birth.
16101277|NCT02153606|Other|Sham Suppository|Sham suppositories will be created by placing a 250 mg glycerin suppository in the diaper once daily starting 48-72 hours after birth. This intervention works as a non-invasive placebo to maintain blinding.
16101278|NCT02153593|Drug|Tranexamic Acid|1g intra-articular before closing the wound surgery
16101279|NCT02153593|Drug|Fibrin glue|5mL intra-articular before closing the wound surgery
16101280|NCT02153593|Procedure|Electrocauterization|Coagulation blood from vessels by means of a electrocautery
16101281|NCT02153580|Biological|Autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes|Given IV
16101282|NCT02153580|Drug|Bendamustine Hydrochloride|Given IV
16101283|NCT02153580|Drug|Cyclophosphamide|Given IV
16101284|NCT02153580|Drug|Etoposide|Given IV
16101285|NCT02153580|Drug|Fludarabine Phosphate|Given IV
16101286|NCT02153567|Drug|Escitalopram|Escitalopram 5mg daily will be given for the first 2 weeks and then Escitalopram 10mg daily will be given for the next 8 weeks.
16101287|NCT02153567|Other|Placebo|Placebo will be given for the next 10 weeks.
16101288|NCT02153554|Behavioral|Training civil servants on attention to violence against women|The Secretary of Women of Medellin, through the ICONTEC, intends to conduct training to officials of the 22 family commissioners in Medellin. The objective of these trainings is to standardize procedures in order that women do not feel re-victimized and can forward complaints.
16101289|NCT02153541|Drug|Antipyrine-benzocaine otic solution|Participants receiving antipyrine-benzocaine otic solution are expected to decrease usage of rescue inhalers.
16101290|NCT02153541|Other|Mineral oil|50% of participants will receive the mineral oil. These participants will be randomly selected and unaware that they are receiving the placebo and are expected to have no change in usage of rescue inhalers.
16101291|NCT02153528|Drug|double rimfampicin|Compared to standard regimen dosing of rifampicin is doubled, while standard dose isoniazid, pyrazinamide and ethambutol are maintained
16101292|NCT02153528|Drug|Standard TB treatment|Standard regimen for TB treatment according to guidelines of the International Union against Tuberculosis and Lung Disease
16101293|NCT02153515|Other|Your own ( autologous) finger prick of blood produced with a diabetic lancet|
16101294|NCT02153502|Drug|AVP-786 (d6-dextromethorphan hydrobromide and quinidine sulfate combination)|AVP-786 capsules administered twice a day over a 10-week period
16101301|NCT02153450|Drug|metformin hydrochloride|Given PO
16101302|NCT02153450|Radiation|stereotactic radiosurgery|Undergo stereotactic radiosurgery
16101303|NCT02153437|Drug|BMS-919373|
16101304|NCT02153437|Drug|Sotalol|
16101305|NCT02153437|Drug|Placebo for BMS-919373|
16101306|NCT02153424|Drug|Apixaban|
16101307|NCT02153398|Drug|D961H sachet 10 mg|
16101308|NCT02153398|Drug|D961H capsule 10mg|
16101309|NCT02153398|Drug|D961H capsule 20 mg|
16101310|NCT02153385|Other|Yoga|Yoga program was 60 min per session, twice per week for 8 weeks. Led by an experienced yoga instructor.
16101311|NCT02153372|Other|BMC2012|
16101312|NCT02153359|Device|High Efficiency Particulate Air Cleaner|
16101313|NCT02153359|Device|Sham air cleaner|
16101314|NCT02153346|Other|Valuation of lost productivity questionnaire|A new, composite questionnaire that can be used to assess the impact of health conditions on lost productivity in monetary units. It measures absenteeism, presenteeism, and non work activities.
16101315|NCT02153346|Other|Work productivity and activity impairment questionnaire|A six item questionnaire used as a patient-reported quantitative assessment of the amount of absenteeism, presenteeism, and daily activity impairment attributable to a specific health problem.
16101316|NCT02153333|Procedure|Serum sample|Serum samples collected at pre-vaccination and at 1-2 months post Dose 2 in the previously conducted clinical trials will be assessed for anti-PCV-1 antibodies in this study. Additionally, pre-vaccination sera samples from any infants testing positive for PCV-1 antibodies at the post-vaccination time point will also be evaluated.
16101317|NCT02153320|Procedure|Blood Sampling|Single blood sample taken from subjects who had participated in the study 287615 (NCT00508833).
16101318|NCT02153307|Device|Implantable loop recorders system Reveal ICM LINQ®,|
16101319|NCT02153294|Procedure|low tidal volume|Patients are randomized and ventilated with a low tidal volume (4-6 ml/kg PBW)
16101320|NCT02153294|Procedure|high tidal volume|Patients are randomized and ventilated with a high tidal volume (8-10 ml/kg PBW)
16101321|NCT02153281|Other|phenelzine treatment|Subjects will have a PET and MRI scan before and after treatment with phenelzine.
16101322|NCT02153268|Procedure|Single Arm - Liposuction procedure and BonoFill transplantation will be done for all subjects on study|"Liposuction - will be performed on Visit 2, BonoFill will be based on subject's autologous Human Adipose Tissue Derived Cells (HATDCs).
~BonoFill Transplantation will be performed on Visit 6. BonoFill will be administrated to the subject in a single session at one tested cell dose."
16101323|NCT02153229|Radiation|Photodynamic Therapy|
16101324|NCT02153229|Procedure|Radical Pleurectomy|
16101325|NCT02153229|Radiation|Chemotherapy|
16101326|NCT02153229|Drug|Photofrin 2.0 mg/kg|If randomized to the RP with PDT arm, subject will receive Photofrin 2.0 mg/kg as an intravenous infusion 24 hours (range 18-30 hours) prior to intra-operative light delivery (PDT) during radical pleurectectomy
16101327|NCT02153203|Behavioral|Prevent-Teach-Reinforce Model|Implementation of the model once to twice per week over a period of 8 weeks
16101328|NCT02153203|Other|Individual Parent Training Session|One 2- to 3-hour individual parent training session on the assessment and treatment of problem behavior
16101329|NCT02153190|Device|HYBRID|During the HYBRID Period, the patient will use the AP model when at home, from dinner to wake-up time whereas the patient will self manage glucose control with insulin pump and CGM for the rest of the day.
16101330|NCT02153190|Device|OPEN|During the control period called OPEN Period, patient self management of diabetes by insulin pump and CGM will be done at all times.
16101331|NCT02153177|Procedure|Rotator cuff repair|Arthroscopic procedure
16101332|NCT02153177|Drug|Ibuprofen, Hydrocodone/Acetaminophen, Omeprazole|In addition to pain medication after the procedure patients will receive Ibuprofen and Omeprazole. Omeprazole is given to minimize the gastrointestinal side effects of Ibuprofen.
16101333|NCT02153177|Drug|Hydrocodone/Acetaminophen|Hydrocodone/Acetaminophen is given for pain control after the surgery.
16101334|NCT02153151|Other|Cytology specimen|Correlative studies
16101335|NCT02153151|Other|Laboratory biomarker analysis|Correlative studies
16101336|NCT02153138|Device|Endo-pat 2000|"The endo peripheral arterial tonometry (PAT) provides an index of endothelial function in two forms:
~The reactive hyperemia index (RHI) is the post-to-preocclusion PAT signal ratio in the occluded side, normalized to the control side and further corrected for baseline vascular tone.
~The logarithm RHI (LnRHI) is s similar index as RHI after natural log transformation with a matched cutoff. LnRHI provides better double-sided distribution than RHI and one that is closer to normal distribution"
16101337|NCT02153138|Device|carotid intima media thickness Ultrasound|cIMT is the distance between the intimal-luminal interface and the medial-adventitial interface. It will be studied by B-mode ultrasonography of the extracranial carotid arteries. A duplex system with a 7-10 megahertz (MHz) linear array multi-frequency transducer will be used.
16101338|NCT02153138|Device|Dexa- Bone densitometer & Bone ultrasonometer System|A means of measuring bone mineral density and body composition by a dual energy X-ray absorptiometry (DEXA) machine
16101339|NCT02153125|Drug|Eplerenone|
16101340|NCT02153112|Biological|GI.1/GII.4 (15/15)|Norovirus GI.1/GII.4 (15 μg/15 μg) bivalent VLP vaccine combined with 500 μg aluminum hydroxide for IM injection
16101341|NCT02153112|Biological|GI.1/GII.4 (15/50)|Norovirus GI.1/GII.4 (15 μg/50 μg) bivalent VLP vaccine combined with 500 μg aluminum hydroxide for IM injection
16101342|NCT02153112|Biological|GI.1/GII.4 (50/50)|Norovirus GI.1/GII.4 (50 μg/50 μg) bivalent VLP vaccine combined with 500 μg aluminum hydroxide for IM injection
16101343|NCT02153112|Biological|GI.1/GII.4 (50/150)|Norovirus GI.1/GII.4 (50 μg/150 μg) bivalent VLP vaccine combined with 500 μg aluminum hydroxide for IM injection
16101344|NCT02153112|Drug|Placebo|Placebo saline solution
16101345|NCT02153099|Drug|TAK-058 (ENV8058)|TAK-058 (ENV8058) oral solution
16101346|NCT02153099|Drug|Placebo|TAK-058 (ENV8058) placebo-matching oral solution
16101347|NCT02153086|Drug|Ramelteon|Ramelteon tablets 8 mg
16101348|NCT02153073|Drug|Omega-3 fatty acid ethyl esters|Omega-3 fatty acid ethyl esters granular capsules
16101349|NCT02153060|Drug|Dexamethasone|Dexamethasone was given at a dose of 40 mg,daily for 4 consecutive days
16101350|NCT02153060|Drug|Dexamethasone|Dexamethasone was given at a dose of 20 mg,daily for 4 consecutive days
16101351|NCT02153047|Behavioral|Spirometry|Will be given a brief but structured smoking cessation advice (according to the standards of the Tobacco Study Group of the Catalan Society of Family Medicine) together with a detailed and structured 20-minutes visit with details of the spirometry data (values of respiratory capacity and volumes referring on the theoretical)
16101352|NCT02153021|Radiation|Phototherapy|"phototherapy: all patientes will received application of phototherapy after exercise session. The phototherapy will be applicated in abdominal and dorsal circumference/ quadriceps and biceps femoral.
~Type Ga-Al-As Wavelength 808nm Frenquency Continue wave Optical output 100mW Spot diameter 0.6mm Power density 60W/cm2 Energy per minute 6J/point Number of Points 64points Total energy delivered 48J"
16101353|NCT02152995|Procedure|Computed Tomography|Undergo iodine I-124 PET/CT
16101354|NCT02152995|Other|Iodine I 124|Undergo iodine I-124 PET/CT
16101355|NCT02152995|Radiation|Iodine I-131|Given PO
16101356|NCT02152995|Other|Laboratory Biomarker Analysis|Correlative studies
16101357|NCT02152995|Other|Pharmacodynamic Study|Correlative studies
16101358|NCT02152995|Procedure|Positron Emission Tomography|Undergo iodine I-124 PET/CT
16101359|NCT02152995|Drug|Trametinib|Given PO
16101365|NCT02152969|Drug|Telmisartan|
16101366|NCT02152969|Drug|Amlodipine|
16101367|NCT02152969|Drug|Chlorthalidone|
16101368|NCT02152956|Drug|Flotetuzumab|Flotetuzumab is a CD123 x CD3 bispecific antibody-based molecular construct referred to as a DART® molecule.
16101369|NCT02152943|Drug|Everolimus|Given PO
16101370|NCT02152943|Other|Laboratory Biomarker Analysis|Correlative studies
16101371|NCT02152943|Drug|Letrozole|Given PO
16101372|NCT02152943|Biological|Trastuzumab|Given IV
16101373|NCT02152930|Drug|Omega-3 fatty acids|1000 mg of omega-3 fatty acid ethylesters, 2 times daily, for 4 weeks, followed by 12 weeks of supervised exercise therapy in combination with 2 times daily omega-3 fatty acid supplementation.
16101374|NCT02152917|Drug|Tranexamic acid|
16101375|NCT02152917|Drug|Floseal®|
16101376|NCT02152891|Behavioral|CHAP-EMS/CP@clinic|Community Paramedicine program to assess cardiovascular, diabetes, and fall risk; discuss lifestyle changes and goals; and refer to appropriate resources.
16101377|NCT02152878|Device|Sham stimulation|For sham tDCS, the device will be turned off after 30 seconds of stimulation.
16101378|NCT02152878|Device|Active stimulation|"For active tDCS, we will place the anode and the cathode over the left and right dorsolateral prefrontal cortex areas, respectively (corresponding to F3 and F4 according to the EEG 10-20 system). We will use 5x5 cm electrodes and a 2mA current for 30 minutes per day. This montage is known as bifrontal setup and has been previously used in major depression trials"
16101379|NCT02152865|Drug|Lupeol|Patients are supposed to apply lupeol cream to one side of their face two times per day for 8 weeks.
16101380|NCT02152865|Drug|Control vehicle|Patients are supposed to apply their control vehicle to the other side of their face for 8 weeks
16101381|NCT02152852|Behavioral|Community Health Worker Intervention|For the intervention group, a trained Community Health Worker (CHW) will provide education, support and service coordination through in-home visits. The CHW will first make an in-home assessment visit. At the assessment visit, the participant has the opportunity to ask questions and sign written consent. During this visit, the CHW assesses the participant's history with diabetes, medication adherence, self-management activities, healthcare utilization and will administer a finger stick blood test for HbA1c and a full lipid panel. After enrollment, the participant receives up to five follow-up educational visits 0.5, 1.5, 3.5, 7 and 10 months later. In addition to scheduled visits, the CHWs work with their participants on an as-needed basis via telephone, or additional home visits.
16101382|NCT02152839|Behavioral|Resistance Exercise|6 Weeks progressive unilateral resistance exercise, 3 times per week, 70% 1-RM, 6 x 8 Repetitions. 2 minutes rest between sets
16101383|NCT02152826|Device|Potassium oxalate|Professional application
16101384|NCT02152813|Behavioral|TENS and Task-orientated training|All subjects will undergo 16 sessions of their assigned intervention (60 minutes, twice a week, for 8 weeks). All subjects will receive 60 minutes task-oriented lower limb training (TOT) with electrical stimulation protocol assigned concurrently:
16101385|NCT02152800|Drug|valacyclovir hydrocholoride|
16101386|NCT02152787|Drug|Injection of propofol 1.0mg/kg|
16101387|NCT02152787|Drug|propofol 0.5mg/kg|
16101388|NCT02152787|Drug|normal saline|
16101389|NCT02152774|Drug|Rho-Kinase Inhibitor|
16101390|NCT02152761|Drug|bimagrumab|Bimagrumab was administered as intravenous infusion starting on Day 1 until week 20.
16101391|NCT02152761|Other|placebo|Matching placebo was administered as intravenous infusion starting on Day 1 until week 20.
16101392|NCT02152748|Genetic|analyze systematically morphological and molecular changes associated with glioblastoma progression and therapy-resistance|
16101393|NCT02152735|Procedure|Cleaning the uterine cavity|These participants will have their uterine cavities cleaned with a dry laparotomy sponge after delivery of the placenta. Per standard protocol, the uterus will be explored with one hand holding a sponge to remove any remaining membranes or placental tissue, while the other hand is placed on the fundus to stabilize the uterus
16101394|NCT02152709|Biological|3 dose of 10µg/0.5ml hepatitis B vaccine|3 dose of 10µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside were administered intramuscular injection at 0, 1, 6 momth interval.
16101395|NCT02152709|Biological|3 dose of 5µg/0.5ml hepatitis B vaccine|3 dose of 5µg/0.5ml hepatitis B vaccine made by recombinant deoxyribonudeic acid techniques in saccharomyces cereviside were administered intramuscular injection at 0, 1, 6 momth interval.
16101396|NCT02152696|Drug|Methotrexate|Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels.
16101528|NCT02151656|Drug|F17464|
16101529|NCT02151656|Drug|Placebo|
16101397|NCT02152696|Procedure|Uterine Evacuation|Uterine evacuation or dilation and curettage. At the clinician's discretion, this can be performed using local anesthesia, sedation or general anesthesia and can use a manual or electrical evacuation.
16101398|NCT02152696|Other|Expectant Management|Pregnancy will be expectantly managed using serum hcg monitoring
16101399|NCT02152683|Device|Renova|Low- Intensity Shockwave
16101400|NCT02152670|Drug|Methylphenidate|
16101401|NCT02152670|Drug|Alpha Methyl Para Tyrosine (AMPT)|
16101402|NCT02152670|Other|[11C]PHNO|
16101403|NCT02152670|Other|[11C]raclopride|
16101404|NCT02152657|Other|Mesenchymal stem cell transplantation|Mesenchymal stem cell transplantation through percutaneous injection.
16101405|NCT02152631|Drug|Abemaciclib|Administered orally
16101406|NCT02152631|Drug|Erlotinib|Administered orally
16101407|NCT02152618|Other|Parent Management Training - Oregon Model (PMTO)|Evidence-based, behavioral parent management training model, Parent Management Training - Oregon Model (PMTO) tailored to address permanency barriers of parents of children with SED.
16101408|NCT02152605|Drug|UMEC/VI|Dry white powder delivered via DPI (2 strips with 30 blisters each, first containing UMEC 62.5 mcg per blister and second containing VI 25 mcg per blister), administered as one inhalation of UMEC/VI 62.5/25 mcg
16101409|NCT02152605|Drug|Placebo|Dry white powder delivered via DPI (2 strips with 30 blisters each, both containing lactose with magnesium stearate), administered as one inhalation of placebo
16101410|NCT02152592|Drug|PCM/Oxy1|Controlled Release oxycodone 10 mg orally twice a day for 24 hours
16101411|NCT02152592|Drug|PCM/Oxy2|CR oxycodone 10 mg orally twice a day for 48 hours
16101412|NCT02152579|Drug|Isosorbide-5-mononitrate|Patients will receive 20mg monocordil tablets (Baldacci Laboratories).
16101413|NCT02152566|Device|Nasal High flow therapy device|Nasal high flow therapy via nasal cannula.
16101414|NCT02152553|Drug|Hydrocortisone|
16101415|NCT02152553|Drug|Placebo|
16101416|NCT02152540|Device|rTMS|Repetitive Transcranial Magnetic Stimulation
16101417|NCT02152540|Device|Sham rTMS|Placebo Device that simulates active rTMS treatment
16101418|NCT02152514|Drug|Intrathecal Morphine/Sufentanil|
16101419|NCT02152514|Device|PCA|
16101420|NCT02152501|Other|Exercise Energy Expenditure 300 kcal/day|
16101421|NCT02152501|Other|Exercise Energy Expenditure 600 kcal/day|
16101422|NCT02152475|Drug|mouthwash with curcumin|Mouthwash with 20 ml of curcumin solution for 5 minutes
16101423|NCT02152475|Device|blue LED illumination|Oral cavity was illuminated with blue light for 5 minutes
16101424|NCT02152462|Other|Exergaming|The participants in the Wii Fit exergaming group will be encouraged to meet and then maintain a goal of 150 min/wk of moderate intensity exercise for 6 months. Goals per individual will be based on their baseline data. Exercise duration will increase gradually from 75 min/wk at week 1 to 150 min/wk by week 4. Thereafter, women will maintain >150 min/wk of moderate-intensity physical activity. The training will consist of 3 days/wk of supervised physical activity using Nintendo Wii Fit active videogames.
16101425|NCT02152449|Dietary Supplement|Oral nutritional supplementation|
16101426|NCT02152436|Other|Simulation - based curriculum|Operating room medical and non-medical members will be asked to carry out a simulation session preceded by an educational maze with videos. Outcomes will be compared and correlated after and before this curriculum
16101427|NCT02152423|Drug|LOVENOX|LMWH
16101428|NCT02152423|Drug|ENOXAMED|LMWH
16101429|NCT02152410|Device|acupuncture|Acupuncture will be applied according to the standards for reporting interventions in clinical trials of acupuncture (STRICTA)
16101430|NCT02152410|Drug|Morphine|bolus of 5 mg of morphine (5 cc) and 2 mg (2cc) every 10 minutes if no improvement of VAS (VAS> 30).
16101431|NCT02152397|Behavioral|Therapist-led brief intervention (TBI)|
16101432|NCT02152384|Drug|Insulin Peglispro|Administered SC
16101433|NCT02152384|Drug|Insulin Lispro|Administered SC
16101434|NCT02152384|Drug|Insulin Glargine|Administered SC
16101435|NCT02152371|Drug|Dulaglutide|Administered SQ
16101436|NCT02152371|Drug|Placebo|Administered SQ
16101437|NCT02152371|Drug|Insulin Glargine|Administered SQ
16101438|NCT02152371|Drug|Metformin|Administered orally
16101439|NCT02152358|Drug|Aciclovir|Intravenous 15 mg/kg/d during 14 days
16101440|NCT02152358|Drug|Ganciclovir|intravenous 10 mg/kg/d for 14 days
16101441|NCT02152358|Drug|Placebo|
16101442|NCT02152345|Drug|Belatacept|"Belatacept 10 mg/kg will be administered in the operating room approximately 1 hour prior to kidney allograft reperfusion (Day 0). It will then be administered at 10 mg/kg on the following post-transplantation days: Day 5, 14, 30, 56, and 84.
~Belatacept 5 mg/kg will be administered every four weeks thereafter until end of study."
16101443|NCT02152345|Drug|Tacrolimus|"Tacrolimus 0.05 mg/kg by mouth every 12 hours will be on Day 0 after transplantation. It will then be administered at 8-12 ng/mL on the following post-transplantation days: Day 3-90; at 8-10 ng/mL Day 91-180.
~Tacrolimus 6 - 8 ng/mL will be administered daily thereafter until end of study.
~(standard of care)"
16101444|NCT02152345|Drug|Mycophenolate|"An immunosuppressive agent used with other medicines to lower the body's natural immunity in patients who receive kidney transplants.
~720 mg by mouth every 12 hours (Day 0)(1080 mg AA).
~(standard of care)"
16101445|NCT02152345|Drug|rATG|"1.5 mg/kg IV daily on Day 0-3.
~(standard of care)"
16101446|NCT02152345|Drug|Methylprednisolone|"500 mg (Day 0), 250mg (Day 1), 125mg (Day 2), 75 mg (Day 3) IV administered from Day 0-3.
~(standard of care)"
16101447|NCT02152345|Procedure|Renal transplant|Standard organ transplant of a kidney into a patient with end-stage renal disease.
16101448|NCT02152332|Drug|JNJ-54861911-Therapeutic Dose|JNJ-54861911 50 mg once daily for 7 days in all treatment sequence.
16101449|NCT02152332|Drug|JNJ-54861911 - Supratherapeutic Dose|JNJ-54861911 150 mg once daily for 7 days in all treatment sequence.
16101450|NCT02152332|Drug|JNJ-54861911-Matched Placebo|JNJ-54861911-matched placebo once daily for 7 days in all treatment sequence.
16101451|NCT02152332|Drug|Moxifloxacin|Moxifloxacin 400 mg on Day 7 in all treatment sequence.
16101452|NCT02152332|Drug|Moxifloxacin Matched Placebo|Moxifloxacin matched placebo, 400 mg on Day 7 in all treatment sequence.
16101530|NCT02151643|Drug|PT20|Modified ferric oxide adipate tablets
16101453|NCT02152319|Device|KHV reporting|Clinicians will view the KHV motor symptom severity reports and use KHV to videoconference with subjects to titrate medications.
16101454|NCT02152319|Procedure|Standard care|Subjects will receive the same disease management as if they were not participating in this study.
16101455|NCT02152306|Drug|Fimasartan and Amlodipine|
16101456|NCT02152306|Drug|Fimasartan|
16101457|NCT02152280|Drug|Danhong Injection|Danhong Injection 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 10 days.
16101458|NCT02152280|Drug|Normal Saline|0.9% sodium chloride solution 40 ml add 250 ml of 0.9% sodium chloride solution, injection intravenous drip, 1 time a day, for 10 days;
16101459|NCT02152267|Device|tDCS|The transcranial direct current stimulation allows the neuronal membranes to neuromodulate and it can enhance or inhibit the potential actions on the cortex. Studies with animals has shown that anodal stimulation modulate the membrane in the way to depolarize which results in a long term potential in the stimulated area
16101460|NCT02152254|Drug|Targeted Therapy Based on Molecular Profiling|Molecular profiling results are used to assign targeted therapy. Patients receive targeted therapy by participating in a Phase I or a Phase II clinical trial. If a clinical trial is not available, and a commercially available targeted therapy exists (Food and Drug Administration [FDA]-approved for another indication), patients can receive the FDA-approved drug.
16101461|NCT02152254|Drug|Standard-of-Care Therapy|Standard-of-care treatment regimen will be left to the discretion of the treating physician.
16101462|NCT02152228|Drug|EnteraBio's Oral Parathyroid Hormone (1-34)|Oral administration
16101463|NCT02152215|Procedure|Acellular dermal matrix membrane|The surgical procedure will consist of a full-thickness papilla preservation flap performed on the buccal and a full thickness flap on the palatal to expose the alveolar ridge and the tooth to be extracted. The group will receive an intrasocket cancellous particulate allograft plus a facial overlay graft using a bovine xenograft covered by an acellular dermal matrix, composed of human connective tissue matrix.
16101464|NCT02152215|Procedure|Polylactic acid membrane|The surgical procedure will consist of a full-thickness papilla preservation flap performed on the buccal and a full thickness flap on the palatal to expose the alveolar ridge and the tooth to be extracted. The group will receive intrasocket cancellous particulate allograft plus a facial overlay graft using a bovine xenograft, covered by a bioabsorbable membrane made of polylactic acid and a citric acid ester
16101465|NCT02152202|Other|Semi-upright position|In this group patients' bed will be set into 45 degree angle during sleep in the night time.
16101466|NCT02152202|Other|Supine position|Control: Supine position during nocturnal sleep for at least two postoperative nights.
16101467|NCT02152189|Other|Screening for Fabry disease|
16101468|NCT02152176|Device|Titration of morphine by Patient Controlled Analgesy|PCA is never used for titration but only for relay of titration. Self-controlled analgesia by PCA is our intervention.
16101469|NCT02152163|Drug|IV Ibuprofen|
16101470|NCT02152163|Drug|placebo|
16101471|NCT02152150|Other|Iron bio-fortified pearl millet|Pearl millet variety ICTP8203-Fe (82 mg/kg iron content) prepared as a traditional flatbread (bhakri)
16101472|NCT02152150|Other|Control pearl millet|Conventional pearl millet: variety DG9444 (22 mg/kg iron content) and JKBH778 (52 mg/kg iron content), prepared as a traditional flatbread (bhakri)
16101473|NCT02152137|Drug|efatutazone|Given PO
16101474|NCT02152137|Drug|paclitaxel|Given IV
16101475|NCT02152111|Dietary Supplement|Coconut flour|Patients 9 months following treatment, starting at 3 months with diet hipoenergetica 3 months washout and sixth month diet hiponergetic more coconut flour.
16101476|NCT02152111|Behavioral|Diet|Patients were instructed to follow the dietary treatment for 6 months.
16101477|NCT02152098|Procedure|Acute Early onset of rehabilitation|Early onset of rehabilitation
16101478|NCT02152098|Procedure|Acute Delayed onset of rehabilitation|Delayed onset of rehabilitation
16101479|NCT02152098|Procedure|Chronic Exercise|Exercise
16101480|NCT02152098|Procedure|Chronic Control|Control
16101481|NCT02152085|Device|Narrow pulse|Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises narrow (0.4 ms) stimulus pulses.
16101482|NCT02152085|Device|Wide pulse|Participants will be randomly assigned to one of two study arms to receive a 6 week treatment of electrical stimulation that comprises wide (1 ms) stimulus pulses.
16101483|NCT02152072|Other|Using Simulation-Based Training to Incorporate Lung Ultrasound into Physical Examination|
16101484|NCT02152059|Drug|BIBF1120|BIBF1120 is a VEGFR, FGFR and PDGFR inhibitor
16101485|NCT02152046|Procedure|ROP exam with spring loaded retractor|
16101486|NCT02152046|Procedure|ROP exam with screw retractor|
16101487|NCT02152033|Behavioral|Home-based Continuing Care|All sessions will occur over the phone or Cisco WebEx meetings. Parents will participate in 5 individual sessions and 1 joint session with their child (45-50 min. each). Young Adults (YAs) will participate in 1-3 individual meetings (30- 45 min. each) and 1 joint session (45-50 min.). In addition, YAs will be contacted weekly for the first 8 weeks of HCC, then every other week for the remaining 24 weeks (20 calls total). He or she will be asked questions addressing risk and protective factors for relapse. Finally, parents will be trained to collect and test their child's urine sample and deliver incentives to the YA contingent upon biologically-verified abstinence and verified engagement in continuing service plan activities. Urine samples will be collected regularly over a 32 week period.
16101488|NCT02152033|Behavioral|Services as Usual|Young Adults (YAs) will be told to follow the continuing service plan recommended by the residential treatment program. Parents will be told to support this and be sent information on continuing care developed by the Treatment Research Institute and the Partnership @ Drugfree.org (http://continuingcare.drugfree.org). We will provide no supplemental services during the study. We will train parents; however, on how to collect urine samples for research purposes only. They will not be trained on how to test the urine sample, only how to collect it and mail the sample to our staff for testing. We will offer separate 4 hour-workshops to parents and YAs after they have completed participation as an added study participation incentive for this group.
16101489|NCT02152020|Behavioral|Survey|
16101490|NCT02152007|Drug|1% sirolimus cream (TD201 1%)|1% sirolimus cream (TD201 1%)
16101491|NCT02151994|Drug|BIA 5-1058|oral administration
16101492|NCT02151994|Drug|Placebo|oral administration
16101493|NCT02151981|Drug|Chemotherapy|Randomization to either Osimertinib or platinum-based doublet-chemotherapy on Day 1 of every 21d cycle in a 2:1 (Osimertinib:platinum-based doublet-chemotherapy) ratio
16101494|NCT02151981|Drug|Cross-over to Osimertinib|"Once subjects on the platinum-based doublet chemotherapy arm are determined to have objective radiological progression according to RECIST 1.1 by the investigator and confirmed by independent central imaging review, they will be given the opportunity to begin treatment with Osimertinib 80mg, once daily. These subjects may continue treatment with Osimertinib even after disease progression, as long as they are continuing to show clinical benefit, as judged by the investigator.
~Subjects who stop platinum-based doublet chemotherapy for reasons other than objective disease progression according to RECIST 1.1 will not be eligible to cross-over to Osimertinib."
16101495|NCT02151968|Procedure|Local Anaesthetic Injection|Local anaesthetic is injected into the eye.
16101496|NCT02151968|Procedure|Ultrasound-Guidance|"Device: Ultrasound Machine
~Peribulbar block local anaesthetic is injected into the eye with ultrasound guidance."
16101497|NCT02151955|Behavioral|Individual|10 to 15 Individual parent child therapeutic intervention focusing on the quality of the parent child relationships using attachment theory and parent infant psychotherapy
16101498|NCT02151929|Device|Bioresorbable vascular scaffold|stenting of an acute thrombotic lesion in patient within STEMI
16101499|NCT02151929|Device|Everolimus eluting stent|stenting of an acute thrombotic lesion in patient within STEMI
16101500|NCT02151916|Other|Dental care, AG, MI & fluoride varnish|Dental care during pregnancy, or soon thereafter, will comprise of a screening oral examination, extractions, restorations, scaling and prophylaxis, if needed, and will take as many dental visits as required to achieve a non-diseased mouth. Fluoride varnish application to the teeth of children in the immediate intervention group will occur when children are aged 6 to 10 months (time of tooth eruption), 12 and 18 months, as well as at 24 months. Oral health anticipatory guidance and motivational interviewing for the caregivers/mothers in the immediate intervention group will occur during pregnancy and when the children are aged 6-10 months (time of tooth eruption), 12 and 18 months.
16101501|NCT02151916|Other|Delayed intervention|Delayed intervention controlled design; all participants ultimately receive the benefits of the interventions. The intervention group receives the interventions when the mother is pregnant until the child is two years old. The delayed intervention group receives the interventions when the child is two years old until the child is three years old.
16101502|NCT02151903|Drug|DI-Leu16-IL2|DI-Leu16-IL2 will be administered per dose and schedule specified in the arm.
16101503|NCT02151890|Biological|Stem Cell|Out of 112 high risk patients for POF diagnosis was established in 10 cases. Endometrial fractional biopsy was taken, stained with H&E stain and by Immunohistochemical (IH) staining by stem cell marker OCT4. IH expression of stem cell was evaluated before and after transplantation according to Edessy Stem Cell Scoring (ESS). After laparoscopic injection of stem cell sample in the ovaries, participants were followed up monthly for a period of one year by hormonal (FSH, LH and E2), clinical (resuming menstruation and pregnancy), US (folliculometry), histopathological (HP), and IH expression of stem cell (stem cell positivity and scoring according to ESS).
16101504|NCT02151877|Drug|Inhaled Nitric Oxide|delivering inhaled Nitric Oxide into the cardiopulmonary bypass circuit during neonatal cardiac surgery
16101505|NCT02151877|Drug|placebo|inhaled Nitric Oxide not delivered to the cardiopulmonary bypass circuit during neonatal cardiac surgery
16101506|NCT02151864|Drug|LDE225|LDE225 will be administered orally, on a continuous once daily dosing schedule at a dose determined by the cohort the patient is enrolled in until progression or unacceptable toxicity develops
16101507|NCT02151851|Biological|Certolizumab Pegol|"Active substance: Certolizumab Pegol
~Pharmaceutical Form: Prefilled syringes
~Concentration: 200 mg/ml
~Route of administration: Subcutaneous injection"
16101508|NCT02151851|Drug|Methotrexate|"Active substance: Methotrexate
~Pharmaceutical form: Tablet
~Concentration: Maximum dose 10 mg per week
~Route of administration: Oral"
16101509|NCT02151851|Other|Placebo|"Active substance: Placebo
~Pharmaceutical form: Prefilled syringes
~Concentration: 0.9 % saline
~Route of Administration: Subcutaneous injection"
16101510|NCT02151825|Dietary Supplement|Synbiotic|3 capsules per day containing 4 billion CFU of Bifidobacterium lactis BB-12, Lactobacillus acidophilus LA-5, Lactobacillus casei 431 and Saccharomyces boulardii in combination with prebiotics Inulin (1 g) and Galactooligosaccharides (100 mg)
16101511|NCT02151825|Other|Placebo|3 capsules of Maltodextrin per day
16101512|NCT02151812|Device|Agent Paclitaxel-coated balloon|After successful pre-dilatation, the index lesion is dilated with a single drug-coated balloon that completely covers the restenotic lesion.
16101513|NCT02151812|Device|SeQuent® Please Paclitaxel-coated Balloon|After successful pre-dilatation, the index lesion is dilated with a single drug-coated balloon that completely covers the restenotic lesion.
16101514|NCT02151799|Procedure|Abdominoplasty and liposuction|
16101515|NCT02151786|Drug|Lansoprazole|Lansoprazole intravenous 30 mg
16101516|NCT02151773|Drug|Freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain)|Freeze-dried live attenuated measles and rubella combined vaccine (Schwarz FF-8 strain/TO-336 strain)
16101517|NCT02151760|Drug|18F-DCFPyL|
16101518|NCT02151734|Drug|KALOMIN™ Tab.|
16101519|NCT02151734|Drug|Umckamin syrup|
16101520|NCT02151721|Drug|Vorinostat, gefitinib|Vorinostat 200, 300, or 400 mg orally once daily on days 1-7 with washout on days 8-14 plus gefitinib 250 mg orally once daily on days 1-14
16101521|NCT02151708|Drug|Placebo|Eligible subjects were randomly allocated in a 1:1:1 ratio to receive either 90mg motilitone or 180mg motilitone or placebo motilitone three times daily for 2weeks.
16101522|NCT02151708|Drug|motilitone|Eligible subjects were randomly allocated in a 1:1:1 ratio to receive either 90mg motilitone or 180mg motilitone or placebo motilitone three times daily for 2weeks.
16101523|NCT02151695|Procedure|panretinal photocoagulation|
16101524|NCT02151695|Drug|Aflibercept intravitreal injections|
16101525|NCT02151682|Drug|Tapentadol prolonged release|
16101526|NCT02151682|Drug|Morphine prolonged release|
16101527|NCT02151669|Behavioral|Mediterranean Diet|Nutritional intervention conducted by a dietitian who designs a nutrition program to enhance the traditional Mediterranean diet pattern using new technology as an educational tool in primary care: DIET blog. Participants will be referred to a single annual visit and one group session per year for two years.
16101531|NCT02151643|Drug|Placebo|Placebo tablets matched to each PT20 dose arm
16101532|NCT02151630|Drug|Pyruvic acid|
16101533|NCT02151630|Drug|Salicylic Acid|
16101534|NCT02151617|Drug|PF-06743649|40 mg tablet one time once with a meal and once without a meal, followed by once daily dosing for 14 days
16101535|NCT02151617|Drug|Placebo|Placebo tablet one time once with a meal and once without a meal, followed by once daily dosing for 14 days
16101536|NCT02151617|Drug|PF-06743649|To be decided dose, tablet once daily dosing for 14 days
16101537|NCT02151617|Drug|Placebo|Placebo tablet once daily dosing for 14 days
16101538|NCT02151617|Drug|PF-06743649|To be decided dose, tablet, one time once with a meal and once without a meal, followed by once daily dosing for 14 days
16101539|NCT02151617|Drug|Placebo|Placebo tablet one time once with a meal and once without a meal, followed by once daily dosing for 14 days
16101540|NCT02151617|Drug|PF-06743649|To be decided dose, tablet, one time without a meal, followed by once daily dosing for 14 days
16101541|NCT02151617|Drug|Placebo|Placebo tablet one time once without a meal, followed by once daily dosing for 14 days
16101542|NCT02151617|Drug|PF-06743649|Tablet, to be decided dose, once daily, 14 days
16101543|NCT02151617|Drug|Placebo|Tablet, once daily, 14 days
16101544|NCT02151604|Drug|Inhalation of hyperpolarized xenon gas|The xenon gas is inhaled immediately before acquisition of an MR image to enable the lung structure to be seen.
16101545|NCT02151591|Drug|Varenicline|"12-weeks of treatment. Dose will be titrated as follows:
~Days 1-3: 1 0.5mg tablet once per day Days 4-7: 1 0.5mg tablet twice per day Day 8 - Week 11: 1 1mg tablet twice per day"
16101546|NCT02151578|Other|home/community case management|
16101547|NCT02151565|Device|HTEMS|
16101548|NCT02151565|Device|TENS|
16101549|NCT02151552|Drug|Endotoxin (E. coli O:113, Reference Endotoxin)|The endotoxin will be reconstituted with sterile water to a final concentration of 2,000 endotoxin units/ml. The dose of 4 ng/kg will be prepared to a final volume of 2 ml and will be administered using a 5F balloon-tipped monitoring catheter inserted via a fiberoptic bronchoscope into the lateral segment of the right middle lobe of the lung on the morning of Day 2.
16101550|NCT02151552|Drug|[18F](+/-)NOS|7 mCi of [18F](+/-)NOS will be injected intravenously at the start of a 60-minute dynamic PET scan acquisition
16101551|NCT02151539|Other|medical chart review|Ancillary studies
16101552|NCT02151539|Other|quality-of-life assessment|Ancillary studies
16101553|NCT02151526|Drug|LentiGlobin BB305 Drug Product|LentiGlobin BB305 Drug Product was administered by intravenous (IV) infusion.
16101554|NCT02151513|Device|Intrathecal Pump Placement|
16101555|NCT02151500|Behavioral|Stress and Health Interview|A stress and health interview which aims to help patients: a) disclose their stressful experiences and emotional conflicts, which might be contributing to their symptoms; b) learn about associations between their stress and physical symptoms; and c) learn about the potential value of experiencing and expressing their emotions related to these stressful situations.
16101556|NCT02151487|Drug|Ropivacaine|Ropivacaine alone
16101557|NCT02151487|Drug|Ropivacaine and dexamethasone|Ropivacaine combination with dexamethasone
16101558|NCT02151487|Drug|Ropivacaine and clonidine|Ropivacaine combination with clonidine
16101559|NCT02151487|Drug|Ropivacaine, dexamethasone and clonidine|Ropivacaine combination with dexamethasone and clonidine
16101560|NCT02151474|Drug|INCB047986|
16101561|NCT02151474|Drug|Placebo|
16101562|NCT02151461|Drug|Low Metformin|1100 mg L Leucine in combination with 125 mg of Metformin BID
16101563|NCT02151461|Drug|Metformin|500 mg metformin BID until day 14 with dose escalation at day 14 to 850 mg metformin BID
16101564|NCT02151461|Drug|Mid Metformin|1100 mg of Leucine in combination with 250 mg Metformin BID
16101565|NCT02151461|Drug|High Metformin|1100 mg of Leucine in combination with 500 mg Metformin BID
16101566|NCT02151448|Biological|DC vaccine|Administered on Monday of each cycle: 1 intranodal ultrasound-guided injection (target dose of 3 x 10e6 cells in 0.5 mL) + 1 intradermal injection (target dose of 3 x 10e6 cells in 0.5 mL)
16101567|NCT02151448|Drug|Celecoxib|Administered at 200 mg, once a day orally, starting the day of the first DC vaccine through week 4/cycle 2. Participants will not take celecoxib while receiving standard of care chemotherapy as instructed by their local oncologist. Celecoxib will continue starting week 20/cycle 3 and continue until the Friday of the last day of the CKM administration, cycle 4. Administered at 400 mg, 200 mg twice a day orally, on days participants receive vaccine and CKM.
16101568|NCT02151448|Drug|Interferon Alfa-2b|Intravenous infusion over 20 minutes: doses tested in Phase 1 portion (5, 10, or 20 MU/m2) will determine the Phase 2 dose. Administered on the Tuesday of each CKM cycle.
16101569|NCT02151448|Biological|rintatolimod|Intravenous infusion of 200 mg on Wednesday and Friday only of the CKM regimen. The protocol allows for de-escalation to 100 mg if attributable adverse effects are observed.
16101570|NCT02151422|Behavioral|Breathing exercise|Patients will be thought 3 different exercises included yoga pranayama, diaphragmatic breathing and pursed lip breathing. Patients will be asked to repeat these exercises at least twice daily for a one month period. Also patients will be thought 4 different exercises which they could use in the event of an asthma exacerbation. Teaching will be supplemented by a breathing exercise brochure and patients will be asked to demonstrate proper technique at initial visit and at the return visit.
16101571|NCT02151409|Drug|NNC 0151-0000-0000|A single dose (SD), administrated i.v. (intravenous) at 8 dose levels.
16101572|NCT02151409|Drug|NNC 0151-0000-0000|A single dose (SD), administrated s.c. (subcutaneously) at 7 dose levels
16101573|NCT02151409|Drug|placebo|A single dose (SD), administrated i.v. (intravenous) or s.c. (subcutaneously).
16101574|NCT02151396|Behavioral|Working memory training|
16101575|NCT02151396|Device|Functional magnetic resonance imaging (fMRI)|
16101576|NCT02151383|Drug|Serelaxin|Serelaxin was administered intravenously for up to 48 hours.
16101577|NCT02151357|Drug|DCBCI0901|DCBCI0901 7.5mg/m2 iv infusion for day 1 to day 5 and day 15 to day 20
16101578|NCT02151344|Biological|H7N9 A/Anhui/13 ca influenza virus vaccine|Participants will receive approximately 10^7.0 fluorescent focus units (FFU) of the vaccine; the vaccine will be administered with a nose spray device.
16101654|NCT02150824|Drug|Placebo|BI 187004 low dose matching placebo once daily
16101579|NCT02151344|Biological|Inactivated subvirion H7N9 vaccine|Participants will receive a dose of 30 mcg of the vaccine; the vaccine will be administered as an injection.
16101580|NCT02151331|Behavioral|External Facilitation|Non-responding sites randomized to receive external facilitation
16101581|NCT02151331|Behavioral|External + Internal Facilitation|Non-responding sites randomized to receive both internal and external facilitation
16101582|NCT02151305|Drug|Propofol, remifentanil|
16101583|NCT02151305|Drug|Sevoflurane|
16101584|NCT02151279|Other|Chitosan as wine fining agent|The possibility of allergic reactions attributed to traces of chitosan used as a fining agent in wine has not been ruled out, particularly in shrimp allergic patients to whom small traces of the potential allergen may be enough to trigger anaphylactic reactions.
16101585|NCT02151279|Other|Control|
16101586|NCT02151266|Behavioral|Exercise and Cognitive retraining|Walking 5 times per week at moderate intensity; cognitive retraining one-hour 2 times per week.
16101587|NCT02151266|Behavioral|Exercise Only|
16101588|NCT02151266|Behavioral|Stretching and Flexibility|
16101589|NCT02151253|Drug|Armodafinil|Armodafinil 50 - 250 mg pills Subjects took armodafinil once daily, before 8 am. Armodafinil was initiated at a dose of 50 mg (1 tablet) and titrated to 150 mg after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 250 mg or reduced back to 50 mg based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
16101590|NCT02151253|Drug|Placebo|Subject given placebo tablets to match Armodafinil pills. Subjects took placebo once daily, before 8 am. Placebo was initiated as 1 tablet and titrated to 3 tablets after 1 week on the basis of the investigator's and patient's perception of efficacy and side-effects. After two weeks the medication could be increased to 5 tablets or reduced back to 1 tablet based on the investigator's and patient's perception of efficacy/side-effects. No increases in dosage were allowed after week 2. The dosage was decreased at a week 3 phone call if indicated on the basis of side-effects.
16101591|NCT02151240|Drug|Foscarnet Sodium|
16101592|NCT02151240|Drug|Acyclovir|
16101593|NCT02151214|Other|Parenteral nutrition|Administration of standard intravenous nutritional products. The products are commonly used in the department where the research is conducted
16101594|NCT02151201|Behavioral|Influenza vaccination video education|Influenza vaccination video education
16101595|NCT02151201|Behavioral|Hand washing video education|Hand washing video education
16101596|NCT02151188|Dietary Supplement|Bread, Soy milk and cow milk|The study will examine the metabolic effects of two liquid proteins (soy milk and cow milk) with carbohydrate (bread) meals.
16101597|NCT02151188|Device|real-time ultrasonography (GE LOGIQ P5 ultrasound in CNRC)|
16101598|NCT02151175|Device|LIFUP|
16101599|NCT02151162|Behavioral|Mindfulness-based stress management program|Mindfulness-based stress management program will be conducted by senior nurses in four individual sessions within these three months. Senior nurses have taken a 7-hour workshop including lectures and role-playing sessions. The detailed manual and videos including lectures will be provided to the senior nurses.
16101600|NCT02151162|Dietary Supplement|Omega-3 fatty acids pills|Omega-3 fatty acids pills will include 1200 mg of eicosapentaenoic acid and 600 mg of docosahexaenoic acid per day.
16101601|NCT02151162|Behavioral|Psychoeducation leaflet|Psychoeducation leaflet will include information about screening of stress, sleep hygiene, relaxation, and a list of consultants about mental health.
16101602|NCT02151162|Dietary Supplement|Placebo pills|Placebo pills will include rapeseed oil, soybean oil, olive oil and fish oil.
16101603|NCT02151149|Drug|nab-paclitaxel|
16101604|NCT02151149|Drug|Carboplatin|
16101605|NCT02151136|Drug|24% sucrose|
16101606|NCT02151136|Drug|Sterile water|
16101607|NCT02151136|Other|Standard care|The current standard of care at the study site is use of topical anesthetic (Ametop or EMLA), upright holding of toddler by parent/caregiver during procedure, use of age appropriate nurse directed distraction, and sucking on a pacifier (if normally used by child)
16101608|NCT02151110|Biological|MEDI4920 3 mg|Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1.
16101609|NCT02151110|Biological|MEDI4920 10 mg|Participants received single IV dose of MEDI4920 10 mg infused on Day 1.
16101610|NCT02151110|Biological|MEDI4920 30 mg|Participants received single IV dose of MEDI4920 30 mg infused on Day 1.
16101611|NCT02151110|Biological|MEDI4920 100 mg|Participants received single IV dose of MEDI4920 100 mg infused on Day 1.
16101612|NCT02151110|Biological|MEDI4920 300 mg|Participants received single IV dose of MEDI4920 300 mg infused on Day 1.
16101613|NCT02151110|Biological|MEDI4920 1000 mg|Participants received single IV dose of MEDI4920 1000 mg infused on Day 1.
16101614|NCT02151110|Biological|MEDI4920 3000 mg|Participants received single IV dose of MEDI4920 3000 mg infused on Day 1.
16101615|NCT02151110|Other|Placebo|Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1.
16101616|NCT02151084|Drug|Selumetinib|
16101617|NCT02151084|Drug|Cisplatin|
16101618|NCT02151084|Drug|Gemcitabine|
16101619|NCT02151071|Device|EnLight|The Lightpoint EnLight beta particle detector is an investigational non CE-marked medical device
16101620|NCT02151071|Device|LightPath|The LightPath Imaging System is an investigational non CE-marked in vitro diagnostic device
16101621|NCT02151058|Drug|Colgate® Regular Cavity Protection|Brushing twice daily with an ADA - Accepted fluoride - containing dentifrice (Colgate Cavity Protection)
16101622|NCT02151058|Drug|Experimental Mouth Rinse|Brushing twice daily with an ADA - Accepted containing toothpaste, followed by rinsing with 10 mL for 60 seconds with the investigational product.
16101623|NCT02151058|Other|Crest® 3D White Multi-Care Whitening Rinse, Glamorous White, Fresh Mint|Brushing twice daily with an ADA - Accepted containing toothpaste, followed by rinsing with 15 mL for 60 seconds with the active comparator.
16101624|NCT02151045|Procedure|Non target epidural infiltration done at L3-L4 stage|For patients included in control arm, a non target posterior epidural space infiltration of corticoids will be done at L3-L4 stage on scan control
16101655|NCT02150824|Drug|BI 187004|BI 187004 medium dose once daily
16101656|NCT02150824|Drug|BI 187004|BI 187004 low dose once daily
16101625|NCT02151045|Procedure|Epidural infiltration on contact of disco radicular conflict|For patients included in experimental arm, an epidural infiltration of corticoids will be done in lateral on contact of disco radicular conflict on scan control.
16101626|NCT02151032|Behavioral|Booklet|Participants read a booklet about colorectal cancer screening tests.
16101627|NCT02151032|Behavioral|Audio CD|Participants listen to an audio CD that will narrate the colorectal cancer screening tests booklet.
16101628|NCT02151032|Behavioral|Video with Non-Moving Images|Participants watch a video with non-moving images about colorectal cancer screening tests on an iPad.
16101629|NCT02151032|Behavioral|Video with Animated Images|Participants watch a video with animated images about colorectal cancer screening tests on an iPad.
16101630|NCT02151032|Behavioral|Questionnaires|Questionnaire completion before and after viewing the program.
16101631|NCT02151019|Radiation|IMRT|IMRT will be given to some patients to enable comparison of the acute grade 2 GI toxicities compared to those patients receiving their radiotherapy by 3-DCRT
16101632|NCT02151006|Drug|DHEA|
16101633|NCT02150993|Drug|Tenofovir + Emtricitabine or Lamivudine + Zidovudine|TDF +FTC or 3TC (Tenofovir disoproxil fumarate 245 mg and emtricitabine 200 mg or lamivudine 300mg) QD (evenings orally with meals) + ZDV (Zidovudine 300 mg) 1 tb BID (mornings and evenings orally)
16101634|NCT02150993|Drug|Tenofovir + Emtricitabine or Lamivudine + Lopinavir/ritonavir|TDF +FTC or 3TC (Tenofovir disoproxil fumarate 245 mg and emtricitabine 200 mg or lamivudine 300mg) QD (evenings orally with meals) + Lop/r (Lopinavir/ritonavir lopinavir 200/50 mg) 2 tbs BID (mornings and evenings orally)
16101635|NCT02150993|Drug|Tenofovir + Emtricitabine or Lamivudine + Raltegravir|TDF +FTC or 3TC (Tenofovir disoproxil fumarate 245 mg and emtricitabine 200 mg or lamivudine 300mg) QD (evenings orally with meals) + RAL (Raltegravir 400 mg) 1 tb BID (mornings and evenings orally)
16101636|NCT02150967|Drug|BGJ398 (infigratinib)|Capsule for oral use
16101637|NCT02150954|Drug|pitocin|
16101638|NCT02150941|Device|BioVac Direct Suction Device|The BioVac Direct Suction Device (US Endoscopy) is an endoscopic device that enhances the suction power of the gastroscope.
16101639|NCT02150941|Device|Standard Endoscopy Suction|Standard Endoscopy Suction refers to the suction provided on the gastroscope (Olympus EVIS EXERA III).
16101640|NCT02150928|Drug|Erwinaze® (Asparaginase Erwinia Chrysanthemi)/Erwinase® (Crisantaspase)|"Enrolled patients will receive asparaginase Erwinia chrysanthemi 25,000 IU/m2 administered intramuscularly (IM) on a Monday/Wednesday/Friday schedule (all dosing regimens will start on a Monday)
~All patients will receive at least 1 course (2 weeks) of treatment with asparaginase Erwinia chrysanthemi (1 course=6 doses), and a maximum number of courses needed to complete their remaining asparaginase therapy (up to 15 courses)
~Eligible patients may not begin treatment with asparaginase Erwinia chrysanthemi until their serum asparaginase activity level is below the assay detectable limit"
16101641|NCT02150915|Other|Acupuncture therapy (leopard spot needling technique)|Comparison of the effects of a new or extraordinary acupoint versus a classical acupoint
16101642|NCT02150902|Procedure|Wide area circumferential catheter ablation|All subjects in the control arm of the trial will undergo wide area circumferential catheter ablation (WACA; lesions delivered 1-2 cm away from the pulmonary vein ostium) around all four pulmonary veins to the endpoint of electrical isolation (demonstrated by entry and exit block using differential pacing). Catheter ablation will be performed using contact force (CF) and electroanatomical mapping system guidance (average CF >10g, FTI > 500 g-sec and minimum ablation duration >10 sec). Dormant pulmonary vein conduction will be tested using adenosine, after completion of the lesion set, and additional lesions will be delivered to eliminate dormant PV conduction.
16101643|NCT02150902|Procedure|Augmented- wide area circumferential ablation procedure|Subjects in this group will have WACA performed as described for WACA. Following completion of the WACA procedure a second set of circumferential ablation lesions will be delivered around the first set of ablation lesions. The ablation catheter tip will be positioned at each of the ablation lesions along the first WACA line and then moved away (from the PV ostia) until healthy, non ablated tissue is recorded from the catheter tip. Energy will be delivered using CF and FTI data as described previously. Once the first WACA ablation line has been completely duplicated the procedure will be deemed complete. In case PV isolation is not achieved after the first WACA lesion set repeat electrophysiologic testing will be performed to determine whether the augmented-WACA procedure was successful in achieving PV isolation.
16101644|NCT02150889|Behavioral|Running Program|16 week supervised running program
16101645|NCT02150889|Behavioral|Yoga Program|once weekly supervised yoga
16101646|NCT02150863|Device|Ultrapulse Carbon Dioxide Laser|
16101647|NCT02150863|Device|Cellutome epidermal harvesting system|
16101648|NCT02150837|Other|5 & 2 & 2 Plan|Medifast has developed the 5 & 2 & 2 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 5 & 2 & 2 Plan consists of 5 Medifast meal replacements, 2 Lean & Green meals, and 2 healthy snacks and provides 1,200-1,400 kcal, >72g protein, >100g of carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack(s) included in this plans consists of a consumer selected serving of grain/starch, dairy, or fruit.
16101649|NCT02150837|Other|4 & 2 & 1 Plan|Medifast has developed the 4 & 2 & 1 Plan as a higher calorie and higher carbohydrate alternative. This plan may be selected for very obese (BMI ≥ 40kg/m2) or older (>65 years) individuals, or for medical (e.g., diabetes) or behavioral reasons (individuals engages in high levels of physical activity). The 4 & 2 & 1 Plan consists of 4 Medifast meal replacements, 2 Lean & Green meals, and 1 healthy snack, providing 1,000-1,200 kcal, >72g protein, >100g carbohydrate, and <30% of calories from fat. The Lean & Green meal is consumer selected and consists of 5-7 ounces of a lean protein, 1 ½ - 3 cups of non-starchy vegetables, and up to 2 healthy fat servings. The healthy snack included in this plans consist of a consumer selected serving of grain/starch, dairy, or fruit.
16101650|NCT02150824|Drug|Placebo|BI 187004 high dose matching placebo once daily
16101651|NCT02150824|Drug|Placebo|BI 187004 medium dose matching placebo once daily
16101652|NCT02150824|Drug|Placebo|BI 187004 high dose matching placebo once daily add on to background metformin
16101653|NCT02150824|Drug|BI 187004|BI 187004 high dose once daily add on to background metformin
16101657|NCT02150824|Drug|BI 187004|BI 187004 high dose once daily
16101658|NCT02150798|Other|High fat and low carbohydrate diet|high fat and low carbohydrate diet. At baseline and at 2 month of following, the variables that were evaluated,
16101659|NCT02150798|Other|Control diet|Control diet. At baseline and at 2 month of following, the variables that were evaluated,
16101660|NCT02150785|Drug|Streptokinase|
16101661|NCT02150772|Procedure|Shear Wave Elastography (SWE)|
16101662|NCT02150759|Drug|Dexmedetomidine|dexmedetomidine infusion during spinal anesthesia
16101663|NCT02150759|Drug|Fentanyl|add dexmedetomidine during position change
16101664|NCT02150759|Drug|Ketamine|add dexmedetomidine during position change
16101665|NCT02150746|Procedure|Peripheral/Central Venous Blood Draw|Baseline sample of whole blood to be assessed for circulating tumor cells. Samples will be acquired via venipuncture unless a pre-existing central venous catheter is in place in which case the sample will be drawn from this.
16101666|NCT02150746|Procedure|Peritoneal Wash|Prior to the start of the surgical resection, irrigation of the abdominal cavity will be performed and collected to determine baseline pancreatic cancer cells that may be present in the abdominal cavity.
16101667|NCT02150733|Drug|Tivantinib|Single oral administration of Tivantinib 120 mg on Day 1 followed by Tivantinib 360 mg twice daily in the extension phase.
16101668|NCT02150733|Drug|Tivantinib|Single oral administration of Tivantinib 120 mg on Day 1 followed by Tivantinib 120 mg twice daily in the extension phase
16101669|NCT02150733|Drug|Tivantinib|Single oral administration of Tivantinib 120 mg on Day 1 followed by Tivantinib 120 mg once daily in the extension phase
16101670|NCT02150733|Drug|Tivantinib|Single oral administration of Tivantinib 120 mg on Day 1 followed by Tivantinib 120 mg once every other day in the extension phase
16101671|NCT02150720|Drug|Tranexamic Acid|1g intra-articular before closing the wound surgery
16101672|NCT02150720|Drug|Fibrin glue|5mL intra-articular before closing the wound surgery
16101673|NCT02150720|Procedure|Electrocauterization|Coagulation blood from vessels by means of a electrocautery.
16101674|NCT02150707|Drug|Dipeptidyl-Peptidase IV Inhibitors|Dipeptidyl-Peptidase IV Inhibitors to treat hyperglycaemia
16101675|NCT02150707|Drug|Glucagon-Like Peptide 1|Glucagon-Like Peptide 1 to treat hyperglycaemia
16101676|NCT02150694|Procedure|Forearm venous occlusion plethysmography|Forearm venous occlusion plethysmography to study to measure forearm blood flow during intra-arterial infusion of the apelin peptides.
16101677|NCT02150694|Procedure|Aellig hand vein technique|Hand vein measurements will be used to assess the response to apelin peptides and apelin receptor blocker in the human hand vein vascular bed.
16101678|NCT02150694|Other|Apelin agonist infusion|Escalating doses of apelin (1/10/100nmol/min) will be administered.
16101679|NCT02150694|Other|Apelin receptor antagonist infusion|Dose finding study (range 1-300nmol/min) and co-infusion study with apelin peptides
16101680|NCT02150681|Behavioral|Mindfulness-based cognitive therapy|This is an 8-week treatment for women with mood disorders. The focus of sessions 1 through 4 is to establish a foundation of mindfulness practice and bringing nonjudgmental awareness to the present moment, beginning with concrete targets of attention and moves to more emotionally challenging and abstract targets (e.g., depression-specific thoughts). Participants are guided to become aware of the automatic patterns of their minds and in such moments to return attention to thoughts, feelings and body sensations. Participants engage experientially with the ways in which thoughts and emotions become engaged with rumination. In sessions 5 through 8, participants learn to extend their basic mindfulness skills to become aware of relapse risk signs and develop prevention plans.
16101681|NCT02150668|Behavioral|Homework, Organization, and Planning Skills (HOPS) Intervention|
16101682|NCT02150668|Behavioral|Homework Support Intervention (HSI)|
16101683|NCT02150655|Biological|Lactobacillus GR-1 and Lactobacillus RC-14 oral capsules|
16101684|NCT02150655|Biological|Placebo|
16101685|NCT02150616|Behavioral|Moderate altitude sojourn|Participants will travel from Zurich (490 m) to St. Moritz Salastrains (2048 m) and stay there for 2 days
16101686|NCT02150616|Behavioral|Low altitude sojourn|Low altitude baseline evaluations will be performed during a stay at Zurich (490)
16101687|NCT02150616|Drug|Oxygen|Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
16101688|NCT02150616|Drug|Sham oxygen (room air)|Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights at 490 m and 2048 m
16101689|NCT02150590|Drug|Oxygen|Nocturnal nasal oxygen during stay at 2048 m
16101690|NCT02150590|Drug|sham oxygen (room air)|
16101691|NCT02150577|Behavioral|Evidence Based Quality Improvement|Facilitation of the identification, adoption, adaption and implementation of evidence based practices.
16101692|NCT02150564|Device|Sonowand|Initially a 2D acquisition will be performed and ultrasound parameters adjusted to obtain the best image resolution. Then anatomical landmarks will be identified if possible and the lesioncharacterized. Once the lesion is identified a rapid 3D-US acquisition will be performed. Tumor resection will proceed guided by the 3D US images using a trackable pointer to navigate. Repeat 3D US images will be obtained as many times as required during the surgery to update the information as tumor debulking proceeds. A final US will be obtained at the end of the procedure and after dural closure
16101693|NCT02150564|Procedure|Navigation|Routine microneurosurgical procedures would be adopted in all cases.Sonowand system will be used for navigation control arm as well as sononavigation experimental arm. Image registration (on the previously imported DICOM images) will be done on the system and after positioning, patient-toimage registration will be completed. The Registration accuracy will be documented.
16101694|NCT02150551|Biological|Allogeneic bone marrow-derived mesenchymal stromal cells|This study is a pilot phase 1 study of patients with moderately to severely active Crohn Disease (CD) and ulcerative colitis (UC) (≥ 18 years, Mayo score: ≥6 or CDAI: ˃ 220; <18 years, Pediatric Crohn's Disease Activity Index (PCDAI) :> 30) or Pediatric Ulcerative Colitis Activity Index (PUCAI) : >34). A fixed dose will be studied: 1 x 106 cells/kg administered intravenously (IV) weekly for 4 consecutive weeks, with the option of an additional 4 weeks of treatment, at the discretion of the principal investigator.
16101695|NCT02150538|Device|Cardiac resynchronization therapy pacemaker|biventricular stimulation with cardiac resynchronization therapy pacemaker (crt-p)
16101696|NCT02150538|Device|Dual chamber pacemaker|right ventricular stimulation with dual chamber pacemaker
16101697|NCT02150525|Dietary Supplement|omega-3 fatty acid|Given PO (by mouth) daily
16101698|NCT02150525|Other|placebo|Given PO(by mouth)daily
16101699|NCT02150525|Behavioral|Questionnaire administration|Measures of self-reported outcomes: Self-reported symptoms will be documented with the Urogenital Atrophy Questionnaire (UAQ), Menopausal Rating Scale (MRS), Female Sexual Function Index (FSFI), Center for Epidemiological Studies Short Depression Scale (CES-D 10), and Brief Pain Inventory (BPI).
16101700|NCT02150512|Device|Transpulmonary Thermodilution|Initial trigger for fluid loading when circulatory insufficiency is present will be SVV. If SVV ≤10% in patients on controlled mechanical ventilation with tidal volumes of ≥8 ml/kg, fluid loading will not be performed. If SVV >10% or spontaneous breathing efforts are present, a fluid challenge should be performed. Also if patients are on controlled mechanical ventilation with tidal volumes of ≤7 ml/kg, a fluid challenge should be performed. If fluid responsiveness is present and SVV decreases to ≤10%, further fluid loading should be stopped. If SVV is still >10%, the increase in EVLW will decide whether to continue fluid loading or not; if EVLW is ≥12 mL/kg PBW and EVLW increases upon fluid loading, further fluid loading should be stopped.
16101701|NCT02150512|Device|Surviving Sepsis Guidelines (SSG)|Initial trigger for fluid loading when circulatory insufficiency is present will be the CVP (target ≥12 mmHg). If circulatory insufficiency is absent, fluid loading will not be initiated or stopped independently of the actual CVP level.
16101702|NCT02150499|Drug|levalbuterol tartrate HFA inhalation aerosol|
16101703|NCT02150499|Drug|placebo|
16101704|NCT02150473|Drug|Adalimumab|adalimumab 40 mg every other week in combination with MTX for 24 weeks
16101705|NCT02150473|Drug|Placebo|Placebo the same amount as adalimumab
16101706|NCT02150460|Procedure|One-site peribulbar injection|injection into the inferior medial orbital compartment
16101707|NCT02150460|Procedure|Two- site peribulbar injection|Two injections into the infero-temporal and supero-nasal orbital compartments
16101708|NCT02150447|Drug|Proton pump inhibitor|Lansoprazole 30 mg, daily
16101709|NCT02150447|Drug|Placebo|Placebo, daily
16101710|NCT02150434|Device|Automated oxygen titration|Automated oxygen titration every second to maintain stable SpO2 at a predefined value (94% in the present study)
16101711|NCT02150434|Drug|Compressed air|compressed air delivered at a fixed flow of 2 L/min
16101712|NCT02150434|Drug|Oxygen constant flow|oxygen delivered at a fixed flow of 2L/min
16101713|NCT02150408|Other|PET-CT|
16101714|NCT02150395|Other|music therapy|
16101715|NCT02150356|Other|Aleurone|Diet based in aleurone-enriched products for a period of 8 weeks.
16101716|NCT02150356|Other|Control|Diet based on refined cereal products for a period of 8 weeks.
16101717|NCT02150343|Drug|HDM-SPIRE|1 dose every 4 weeks
16101718|NCT02150343|Drug|Placebo|1 dose every 4 weeks
16101719|NCT02150330|Drug|Dehydroepiandrosterone (DHEAS)|
16101720|NCT02150317|Procedure|TACE+Sorafenib|TACE followed by Sorafenib
16101721|NCT02150317|Procedure|TACE|TACE alone
16101722|NCT02150291|Dietary Supplement|Folic acid|
16101723|NCT02150291|Drug|Neurobion|
16101724|NCT02150291|Drug|placebo|
16101725|NCT02150278|Behavioral|Brief intervention|The brief intervention consist of one face to face minimal advice to reduce drinking-driving behavior and it was personalized according to the state of change of the patient (based on the Prochaska and DiClemente model). An additional informative pamphlet is offered to the participant. The intervention was done by the general practitioner or nurse that regularly attends the patient.
16101726|NCT02150265|Behavioral|SMART manual cognitive behavioral therapy|
16101727|NCT02150252|Drug|Bu-Yang-Huan-Wu Tang|control group,Recruited patients should be received the placebo-BYHWT 3.0 g TID every day for continuously 6 weeks except ordinary medical care; 2) treatment group, the method is identical control group
16101728|NCT02150239|Procedure|operation|
16101729|NCT02150226|Device|Lava plus (3M) crowns and bridges|Zirconia monolithic dental crowns and bridges evaluation
16101730|NCT02150213|Procedure|MRI, CT or ultrasound was permitted if MRI was contraindicated|MRI/CT/ultrasound of abdomen
16101731|NCT02150213|Procedure|Dexamethasone Supression Test|Low dose of dexamethasone is administered in the evening; the next morning, a blood sample is collected to measure cortisol
16101732|NCT02150213|Procedure|Sonogram|Sonogram of the uterus (females only)
16101733|NCT02150213|Procedure|Biopsy|Uterine endometrial biopsy (females only)
16101734|NCT02150213|Drug|BGG492|No study-drug was administered in this study
16101735|NCT02150200|Other|shorter hospitalization stay|
16101736|NCT02150200|Other|questionnaires|
16101737|NCT02150187|Dietary Supplement|HCap Formula|Pill should be taken every other day during the treatment phase.
16101738|NCT02150187|Dietary Supplement|Placebo|Similar pills without active ingredients
16101739|NCT02150174|Behavioral|Retrieval practice effect using word pairs and cued recall tests with feedback|"In the first phase (encoding), people study a list of 48 word pairs non semantically associated.
~Then (initial test), they recall half of word pairs or restudy the other half.
~In the second phase (final test) which takes place 2 days later, they recall all the 48 the word pairs."
16101740|NCT02150161|Drug|Lidocaine/ ketamine|
16101741|NCT02150161|Drug|Fentanyl|
16101742|NCT02150148|Behavioral|Experimental: Mentored Gardening Intervention|receives raised bed or earthboxes and gardening supplies and instruction on vegetable gardening
16101743|NCT02150135|Other|Oncothermia|Oncothermia is a kind of hyperthermia treatment. It serves heat energy more selectively than conventional hyperthermia.
16101744|NCT02150122|Dietary Supplement|Vitamin D3|
16101745|NCT02150109|Device|Subjects WITH/WITHOUT Diabetes Use Karajishi Contour BGMS|Untrained subjects WITH and WITHOUT diabetes use Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma.
16101827|NCT02149524|Drug|Herceptin (trastuzuamb)|Intravenous administration
16101828|NCT02149524|Drug|SB3 (proposed trastuzumab biosimilar)|Intravenous administration
16101746|NCT02150109|Device|Subjects WITH Diabetes Use Karajishi Contour BGMS|Untrained subjects WITH diabetes use the Karajishi Contour BGMS (Blood Glucose Monitoring System). Subjects tested capillary fingerstick blood (and study staff tested subject fingerstick blood) using the Karajishi Contour BGMS. All BG results were compared to reference method results obtained with subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma.
16101747|NCT02150096|Other|continuous ultrasound group|the group will be treated with 1,5 W/cm² 6 minutes in each side of the lumbar spine in 6 points around the lumbar spine
16101748|NCT02150096|Other|pulsed ultrasound group|the group will be treated with 1,5 W/cm² 6 minutes in each side of the lumbar spine in 6 points around the lumbar spine
16101749|NCT02150096|Other|low level laser therapy group|the group will be treated with 3 J 6 minutes in each side of the lumbar spine in 6 points around the lumbar spine
16101750|NCT02150083|Procedure|OR retrograde fill|
16101751|NCT02150070|Drug|ASP2408|Intravenous (IV) infusion and subcutaneous (SC) injection
16101752|NCT02150070|Drug|Placebo|Intravenous (IV) infusion and Subcutaneous (SC) injection
16101753|NCT02150057|Device|Breg Fusion Unloading Brace|This group is assigned to wear an unloading brace and report pain and quality of life by completion of a pain diary and related questionnaires.
16101754|NCT02150044|Device|Acclarent Tympanostomy Tube Delivery System (TTDS).|tympanostomy tube delivery system
16101755|NCT02150031|Drug|0.2% Chlorhexidine|mouthwash with 10 ml for 1 minute
16101756|NCT02150031|Drug|1% Chlorhexidine|subgingival irrigation
16101757|NCT02150031|Drug|1% Chlorhexidine|supragingival irrigation
16101758|NCT02150031|Procedure|Blood extraction|Blood extraction using an intravenous access at baseline, 30 seconds after antiseptic aplication, 30 seconds and 15 minutes after tooth extraction.
16101759|NCT02150031|Drug|Lidocaine plus adrenaline|local anaesthesia using lidocaine plus adrenaline (1:100,000) no more than 2 cartridges.
16101760|NCT02150031|Procedure|Tooth extraction|dental extraction
16101761|NCT02150018|Other|non invasive ventilation|
16101762|NCT02150005|Procedure|Periodontal treatment|
16101763|NCT02149992|Dietary Supplement|myo-inositol|myo-inositol, oral, 2g, twice a day for 5 days total
16101764|NCT02149992|Device|Continuous glucose monitoring surveillance|monitoring device will be placed by experienced research members to the patient on Day 1 and she will continue to wear until Day 7. This device monitors overall glycemia every 5 minutes and records the information, which can be downloaded after discontinued.
16101765|NCT02149992|Device|Glucose monitoring|patients will use the glucose meter, test strips, and lancets to determine her capillary glucose levels 4 times per day (fasting, and 1 hour post-prandial levels)
16101766|NCT02149979|Device|Temperature Controlled Laser Soldering|This study had a prospective within-subject design. Patients allocated to laparoscopic cholecystectomy procedure were enrolled. After the completion of the laparoscopic cholecystectomy surgical procedure, 4 trocar port sites were randomly either sutured or laser soldered by employing the temperature-controlled laser soldering system.
16101767|NCT02149966|Drug|AG-348|A range of doses of AG-348 will be tested based on the assessment of safety and tolerability. AG-348 will be administered by mouth (orally) each day for a period of 14 days.
16101768|NCT02149966|Drug|Placebo|Placebo will be administered by mouth (orally) each day for a period of 14 days.
16101769|NCT02149953|Dietary Supplement|Glycine Intake|Oral consumption of eight hourly experimental meals- Includes 4 tracer-free experimental meals containing a mixture of free amino acids, calories from a flavored liquid and protein free cookies and 4- labeled amino acid experimental meals.
16101770|NCT02149940|Other|heart-failure related pharmaceutical intervention|
16101771|NCT02149927|Drug|Sevoflurane|
16101772|NCT02149914|Device|Ryodoraku|Ryodoraku to assess the energy of meridian system for each patient before and after taking the medication
16101773|NCT02149914|Device|ANSWatch|ANSWatch to assess the autonomic nervous system for each patient before and after taking the medication
16101774|NCT02149914|Device|UGI endoscopy|UGI endoscopy to assess the grade of reflux esophagitis for each patient before and after taking the medication
16101775|NCT02149914|Other|GerdQ|GerdQ to assess the severity of GERD for each patient before and after taking the medication
16101776|NCT02149914|Drug|PPI|
16101777|NCT02149901|Drug|Pseudoephedrine + 480 ml water|30 mg pseudoephedrine to be given with a pressor dose (480 ml) of drinking water
16101778|NCT02149901|Drug|Pseudoephedrine + 50 ml water|Pseudoephedrine given with a non-pressor (50 ml) dose of drinking water
16101779|NCT02149901|Other|Placebo + 480 ml water (optional)|placebo PO with a pressor (480 ml) dose of drinking water
16101780|NCT02149901|Other|Placebo + 50 ml water (optional)|placebo PO with a non-pressor (50 ml) dose of drinking water
16101781|NCT02149888|Drug|Tenofovir/emtricitabine|Once daily Tenofovir/emtricitabine (Truvada®)
16101782|NCT02149875|Drug|Dl-3-n-butylphthalide|Intravenous infusion of 100 ml dl-3-n-butylphthalide and sodium chloride injection for 10 days, twice daily.
16101783|NCT02149875|Drug|Cerebrolysin|Intravenous infusion of 30 ml Cerebrolysin per day in 100 ml normal saline for 10 days.
16101784|NCT02149875|Drug|Placebo|100 ml saline intravenous infusion once daily for 10 days.
16101785|NCT02149862|Other|Urine infrared analysis|Collected urine sample will be stored at -80°C for further infrared analysis. Spectra will be analyzed by visual inspection, and statistical method such as Principal Components Analysis and logistic regressions methods.
16101786|NCT02149849|Procedure|Modified lateral positioning.|Right before surgery, the patient are posistioned in lateral position with arm elevated (not more than 90 degree from torso). In the intervention, the arm will be lowered and placed in towards the torso for patients enrolled in the experimantal arm.
16101829|NCT02149459|Radiation|Partial brain re-irradiation.|Partial brain re-irradiation to a dose of 30-35Gy delivered over 2 weeks (10 fractions).
16101830|NCT02149459|Drug|Metformin|Different cohorts will receive no, low dose or higher dose metformin.
16101831|NCT02149459|Behavioral|low carbohydrate diet|Under close supervision of a dietician, patients will receive a low carbohydrate diet, enriched as necessary with medium chain triglyceride (MCT) supplements.
16101865|NCT02149212|Procedure|Unna boot dressing|CEAP 6 > Unna boot dressing
16102292|NCT02145910|Radiation|Radiosurgery (SRS)|Undergo SRS
16101787|NCT02149836|Drug|ezogabine|"Treatment Week 1: 100mg of Ezogabine by mouth three times per day (total daily dose = 300mg) Treatment Week 2: dose will be increased to 150 mg Ezogabine by mouth three times per day (total daily dose = 450mg).
~Treatment Week 3: dose will be increased to 200mg of Ezogabine by mouth three times per day (total daily dose = 600mg).
~Treatment Week 4: dose will be increased to 250mg of Ezogabine by mouth three times per day (total daily dose = 750mg).
~Treatment Week 5: dose will be increased to 300mg of Ezogabine by mouth three times per (total daily dose = 900mg).
~Participants will continue to take 900mg of Ezogabine per day and return weekly to the clinic for the remainder of the study.
~Following this primary outcome visit, participants will be instructed to taper the study medication over the following 3 weeks based on FDA recommended guidelines as follows:
~250 mg po TID daily x 1 week, then 200 mg po daily x 1 week, then 100 mg po daily x 1 week, then discontinue"
16101791|NCT02149810|Behavioral|Automatic Self Transcending Meditation|as above
16101792|NCT02149797|Procedure|Four port laparoscopic cholecystectomy|Classical four port laparoscopic cholecystectomy
16101793|NCT02149797|Procedure|SILC-Pick'n roll-Beginning (group I)|"SILC-PR was performed by the intraumbilical single port technique. A 10-mm, 30º scope was used. The surgeon was elevated gallbladder fundus with left hand using grasper in whole operation. If required, infindibulum was freed with monopolar hook. A 2.0 straight needle was inserted through the right of the falciform ligament, grasped with a laparoscopic needleholder using by surgeon's right hand, and passed through the Hartmann's pouch at the lowest point. To allow free manipulation, the passing suture with needle was turned around the suture to form a half-knot. The needle was passed back out from the right of the midclavicular line. An assistant was grasped two ends of the suture and with the help of right or left hand dominant pulling tension, critical view of safety was provided"
16101794|NCT02149797|Procedure|SILC-Pick'n roll-Experienced (group II)|Similar technique of SILC-Pick'n roll-Beginning (group I) was used
16101795|NCT02149784|Procedure|Surgical resection of primary tumor|Surgical resection of primary tumor of mCRC patients who were respond to first line chemotherapy'
16101796|NCT02149771|Procedure|chemoembolization|Conventional chemoembolisation by administering Doxorubicin and Oxaliplatin mix with 5-20 mL iodised oil.Gelatine sponge was used to embolise the feeding artery of the tumour.Repeat if patients with viable lesions demonstrated by CT or MRI.
16101797|NCT02149771|Device|endovascular stents implantation|Bare stents implant within portal vein.
16101798|NCT02149771|Procedure|iodine-125 seed strand implantation|Iodine-125 seed strand implant within portal vein.
16101799|NCT02149758|Drug|Etoricoxib|
16101800|NCT02149745|Procedure|Calling the patient's name|calling the patient's name during anesthesia reversal
16101801|NCT02149745|Procedure|Not calling the patient's name|giving verbal stimulus other than the patient's name during anesthesia reversal
16101802|NCT02149732|Biological|cultivated oral mucosal epithelial sheet transplantation|Autologous cultivated oral mucosal epithelial cell sheet transplantation using oral mucosal adult stem cells in the patients with intractable corneal limbal deficiency
16101803|NCT02149719|Other|Desensitisation using boiled peanut|
16101804|NCT02149719|Other|Desensitisation using boiled peanut (deferred start)|
16101805|NCT02149706|Biological|NeuroVax|NeuroVax consists of a Trivalent TCR Peptide Formulation in IFA
16101806|NCT02149706|Biological|IFA Incomplete Freund's Adjuvant|IFA Placebo Incomplete Freund's Adjuvant
16101807|NCT02149693|Other|high-fidelity simulation and teamwork training|
16101808|NCT02149693|Other|traditional resuscitation training|
16101809|NCT02149667|Device|total hip arthroplasty implant|
16101810|NCT02149654|Device|Engager Transcatheter Aortic Valve Implantation System|The Engager Transcatheter Aortic Valve Implantation System is indicated for use in patients with symptomatic severe aortic valve stenosis requiring aortic valve replacement and are at high or extreme risk for operative mortality or comorbidity judged by the heart team to pose an absolute or relative contraindication for conventional aortic valve replacement. The system is intended for use in patients with a life expectancy of at least one year following TAVI. The intended performance of the system is to provide relief of aortic valve obstruction without inducing significant regurgitation, thereby restoring effective hemodynamic function of the diseased aortic valve. The intended purpose of the system in this clinical study is in line with the intended purpose in the Instructions for Use.
16101811|NCT02149641|Radiation|Intensity modulated radiotherapy with chemotherapy|
16101812|NCT02149628|Drug|propofol|
16101813|NCT02149628|Drug|Desflurane|
16101814|NCT02149615|Other|Retinal nerve fibre layer measurement|Measurement of retinal nerve fibre layer thickness using optic coherence tomography.
16101815|NCT02149602|Radiation|Intensity modulated radiotherapy|Bilateral superficial lobe parotid sparing intensity modulated radiotherapy
16101816|NCT02149589|Procedure|Mechanical ventilation|
16101817|NCT02149576|Procedure|Low Dose Computed Tomography Imaging|
16101818|NCT02149576|Procedure|Chest Radiograph Imaging|
16101819|NCT02149563|Device|oxygen-enriched air -Normobaric hyperoxia treatment for depression|Forty percent oxygen or regular air will be supplied from oxygen concentrators, through standard plastic nasal prongs, at a flow rate of 5 liters/minute, for 7 hours a day, throughout the night.
16101820|NCT02149550|Other|NF135 n=5|Subjects will be infected with the NF135.C10 strain of Plasmodium falciparum through the bites of 5 infected Anopheline mosquitoes.
16101821|NCT02149550|Other|NF135 n=2|Subjects will be infected with the NF135.C10 strain of Plasmodium falciparum through the bites of 2 infected Anopheline mosquitoes.
16101822|NCT02149550|Other|NF135 n=1|Subjects will be infected with the NF135.C10 strain of Plasmodium falciparum through the bite of 1 infected Anopheline mosquito.
16101823|NCT02149550|Other|NF166 n=5|Subjects will be infected with the NF166.C8 strain of Plasmodium falciparum through the bites of 5 infected Anopheline mosquitoes.
16101824|NCT02149550|Other|NF166 n=2|Subjects will be infected with the NF166.C8 strain of Plasmodium falciparum through the bites of 2 infected Anopheline mosquitoes.
16101825|NCT02149550|Other|NF166 n=1|Subjects will be infected with the NF166.C8 strain of Plasmodium falciparum through the bite of 1 infected Anopheline mosquito.
16101826|NCT02149537|Drug|hydroxyurea|
16101832|NCT02149446|Device|Surgisis (C-SLRA-ECH60) made by COOK Medical|Surgisis is extracellular matrix collagen made of the submucosal layer of pigs intestines. Surgisis is gradually remodeled, leaving behind organized tissue
16101833|NCT02149433|Drug|Prednisone|The steroid regime will be oral prednisone at 2 mg/kg for 7 days, then 1 mg/kg for 7 days, then 0.5mg/kg for 7 days for a total of 21 days.
16101834|NCT02149433|Drug|Placebo|
16101835|NCT02149420|Drug|VAY736|
16101836|NCT02149420|Drug|Placebo|
16101837|NCT02149407|Drug|Glycerin|"Glycerin group GG will receive the 0.5 suppository (700 mg) twice daily for 48 hours. We will use the rounded part and discard the other part then will hold baby's buttocks for 2 minutes to ensure its delivery."
16101838|NCT02149407|Procedure|Rectal stimulation|"Rectal stimulation SG by soft cotton swab inserted to around 3 cm. The stick will press against the rectal wall in all direction for 2 minutes twice daily for 48 hours. Ky gel will be used to lubricate the stick and minimize direct friction to rectal wall."
16101839|NCT02149407|Other|Control|"Control group CG will receive routine NICU medical care without any specific intervention for the infant. The research nurse will do shame placebo twice daily by opening his diaper to blind the team for 2 minutes."
16101840|NCT02149394|Other|Ice popsicle|"Patients were assessed according to the following criteria before each intervention: level of awareness; airway protection capacity; and absence of nausea and vomiting, according to the Safety Protocol for Thirst Management. The experimental group received an ice popsicle made of 10 mL mineral water.
~The ice popsicles were made according to the predetermined volumes and packed in the freezer of the anesthetic recovery room at the institution researched. The block of ice were supported by a stick, allowing the patients to control the intensity of cold conferred by the ice for their comfort."
16101841|NCT02149394|Other|Water at room temperature|Patients were assessed according to the following criteria before each intervention: level of awareness; airway protection capacity; and absence of nausea and vomiting, according to the Safety Protocol for Thirst Management. The usual activities adopted by the nursing staff of the anesthetic recovery room were maintained for the control group that received 10 mL mineral water at room temperature in a syringe.
16101842|NCT02149381|Behavioral|CBASP|Cognitive behavioral group intervention for individuals suffering from chronic depression
16101843|NCT02149381|Behavioral|Befriending|Social support intervention, sessions once per week
16101844|NCT02149381|Other|Treatment as usual|Conventional psychiatric outpatient treatment (individual counseling)
16101845|NCT02149355|Other|teeth molding|teeth molding in patients suffering from congenital fourth nerve palsy
16101846|NCT02149342|Drug|Hexylaminolaevulinate cream|0.2% Hexylaminolaevulinate (Hexvix, Photocure) mixed with Unguentum M (Allmiral) cream (2014)
16101847|NCT02149342|Drug|Methylaminolaevulinate cream|MAL 16% is used as photosensitizer for daylight-PDT
16101848|NCT02149329|Drug|Discontinuation of imipenem-cilastatin or meropenem|Discontinuation of imipenem-cilastatin or meropenem after 3x24 hours irrespective of presence of fever.
16101849|NCT02149316|Procedure|RIPC+RIPostC|Four 5 min cycles of upper limb ischemia and reperfusion by a cuff inflated to 200 mmHg, twice (after anesthesia induction and before surgery started, at 20min after aortic declamping)
16101850|NCT02149316|Procedure|control|a deflated cuff placed on the right upper arm
16101851|NCT02149303|Drug|Dabigatran 75 mg|PO BID
16101852|NCT02149303|Drug|Dabigatran 150 mg|PO BID
16101853|NCT02149290|Device|Trends-equipped LifeVest 4000|LifeVest 4000 monitors patients for VT/VF, notifies the patient if VT/VF occurs, and instructs them to press response buttons. In unresponsive patients, LifeVest delivers defibrillation therapy. Trends modifications for heart failure monitoring include: body position data collection; heart rate measurements, activity data collection; ability to perform a health survey; ability to guide patients through a walk test
16101854|NCT02149277|Drug|Filgrastim|The fertility specialist will inject the study medication or its placebo on the 6th day of gonadotrophin stimulation for IVF subjects. For the subjects undergoing embryo transfer, the injection will be done once the endometrial lining measure more than 8mm.
16101855|NCT02149264|Drug|Testosterone gel (FE 999303)|
16101856|NCT02149251|Genetic|Pre-genetic diagnosis|
16101857|NCT02149238|Dietary Supplement|flavanol|
16101858|NCT02149238|Dietary Supplement|methylxanthine|
16101859|NCT02149238|Dietary Supplement|flavanol + methylxanthine|
16101860|NCT02149225|Drug|APVAC1 vaccine plus Poly-ICLC and GM-CSF|"APVAC1 vaccines (i.d.) will be individually assembled for each patient and can be applied to the patient approx. 3 months after enrollment. APVAC1 drug products are composed of 5 to 10 peptides from the GAPVAC warehouse. The APVAC1 vaccine will be applied concurrent to maintenance TMZ cycles after completion of chemoradiation therapy (CRT). Beginning on day 15 of the first maintenance TMZ cycle, patients will receive 11 vaccinations with APVAC1 drug products during 22 weeks. 578 μg per peptide per vial are used.
~Poly ICLC (1.5 mg s.c.) will be used as immunomodulator with all vaccinations except the second applications of APVAC1 (Day 2) and APVAC2 vaccines (Day 2*) to avoid dose accumulation on consecutive days.
~The 2. immunomodulator GM-CSF (75 μg) will be applied i.d. with the first six vaccinations with both vaccines, APVAC1 and APVAC2. A total of 12 GM-CSF doses will be applied. GM-CSF will be applied to the APVAC vaccination site 10-30 min before injection of the APVACs."
16101861|NCT02149225|Drug|APVAC2 vaccine plus Poly-ICLC and GM-CSF|"APVAC2 vaccines (i.d.) will be ready for use ca. 6 months after enrollment, as these peptides have to be newly synthesized for each patient following identification of the mutanome and corresponding mutated peptides in the HLA ligandome. APVAC2 drug products are composed of 1 or 2 peptides de novo synthesized for an individual patient. Patients will be repeatedly vaccinated with APVAC2 drug products beginning on day 15 of the 4. maintenance TMZ cycle. Patients will receive 8 vaccinations within 10 weeks. 578 μg per peptide per vial are used.
~Poly-ICLC (1.5 mg s.c.) will be used as immunomodulator with all vaccinations except the second applications of APVAC1 (Day 2) and APVAC2 vaccines (Day 2*) to avoid dose accumulation on consecutive days.
~GM-CSF (75 μg) will be applied i.d. with the first six vaccinations with both vaccines, APVAC1 and APVAC2. A total of 12 GM-CSF doses will be applied. GM-CSF will be applied to the APVAC vaccination site 10-30 min before injection of the APVACs."
16101862|NCT02149212|Drug|Phlebotonic|Aminaftone -- 75 mg BID
16101863|NCT02149212|Device|Stent|Iliac Vein Stenting
16101864|NCT02149212|Procedure|Limb elastic compression support|CEAP 3-5 > 20-30 mmHg compression stockings CEAP 6 > elastic bandages
16101866|NCT02149199|Drug|budesonide/formoterol 'as needed' + budesonide placebo bid|Symbicort (budesonide/ formoterol) 160/4.5 μg powder for inhalation 'as needed' plus Pulmicort placebo 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment
16101867|NCT02149199|Drug|terbutaline 'as needed' + placebo budesonide bid|Terbutaline 0.4 mg powder for inhalation 'as needed' plus placebo Pulmicort (budesonide) 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening), 52-week treatment
16101868|NCT02149199|Drug|budesonide bid + terbutaline 'as needed'|Pulmicort (budesonide) 200 μg powder for inhalation, 1 inhalation twice daily (morning and evening) plus terbutaline 0.4 mg powder for inhalation 'as needed', 52-week treatment
16101869|NCT02149186|Device|iCTuS-L|
16101870|NCT02149173|Procedure|Computed Tomography|Undergo F-18 FES PET/CT
16101871|NCT02149173|Procedure|Computed Tomography|Undergo FDG PET/CT
16101872|NCT02149173|Drug|F-18 16 Alpha-Fluoroestradiol|Undergo F-18 FES PET/CT
16101873|NCT02149173|Drug|Fludeoxyglucose F-18|Undergo FDG PET/CT
16101874|NCT02149173|Other|Laboratory Biomarker Analysis|Correlative studies
16101875|NCT02149173|Procedure|Positron Emission Tomography|Undergo F-18 FES PET/CT
16101876|NCT02149173|Procedure|Positron Emission Tomography|Undergo FDG PET/CT
16101877|NCT02149160|Drug|FRM-0334|
16101878|NCT02149160|Drug|Placebo|
16101879|NCT02149134|Dietary Supplement|TeHF2013-01|
16101880|NCT02149121|Biological|CT-P10|1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion
16101881|NCT02149121|Drug|Rituxan|1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion
16101882|NCT02149121|Drug|MabThera|1000mg by intravenous infusion. 2 infusions with a 2-week interval between the first and second infusion
16101883|NCT02149108|Drug|Nintedanib (BIBF 1120)|
16101884|NCT02149108|Drug|Placebo|
16101885|NCT02149108|Drug|BSC|
16101886|NCT02149108|Drug|BSC|
16101887|NCT02149095|Drug|TransCon PEG treprostinil|
16101888|NCT02149082|Device|Infrascanner Model 2000|The Infrascanner Model 2000 device is a small, portable handheld device that uses near infrared (NIR) technology to screen patients for intracranial bleeding.
16101889|NCT02149056|Behavioral|observation|
16101890|NCT02149056|Other|Impaired Glucose Tolerance|Impaired Glucose Tolerance
16101891|NCT02149043|Device|Thermography|Thermographic imaging of the patient's abdomen surface
16101892|NCT02149043|Procedure|Colonoscopy|Endoscopic examination of the colon
16101893|NCT02149030|Other|Cytological screening in A1 and A3|Cytological screening.
16101894|NCT02149017|Radiation|SNUBH-NM-333(18F)|5-10 mCi
16101895|NCT02148978|Drug|Saxagliptin|The participants in this study will undergo an OGTT at recruitment and then will start treatment with the DPP IV inhibitor- Saxagliptin at a dose between 2.5- 5mg a day. After 6 weeks of treatment the participants will return to perform a second OGTT.
16101896|NCT02148965|Behavioral|Physical Exercise / Physical Activity|Lifestyle intervention Exercise intervention, three weekly sessions. Each session will last around 60 minutes and will include aerobic exercises (treadmill or stationary cycling) and strength training (with focus on major muscle groups and pregnancy-specific exercises to help alleviate low back pain and work abdominal and pelvic floor muscles to prevent urinary incontinence).
16101897|NCT02148952|Behavioral|WHO Safe Childbirth Checklist Program|The IHF group will receive the WHO Safe Childbirth Checklist Program designed to maximize likelihood of effective and sustained uptake of the program by birth attendants in the designated facilities. The program includes three key implementation steps that involve: engagement of leadership and clinicians at the state, district, and local levels, a formal launch to introduce the Checklist, and support through peer coaching and data feedback. The intervention facilities will also receive a standardized maternity register to ensure appropriate data collection.
16101898|NCT02148913|Drug|Cohort 1: Carfilzomib 15 mg/m2|Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 15 mg/m2 on day -2, -1, + 5 and +6
16101899|NCT02148913|Drug|Cohort 2: Carfilzomib 20 mg/m2|Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 100 mg/m2 on day -2 and day -1 Carfilzomib 20 mg/m2 on day -2, -1, + 5 and +6
16101900|NCT02148913|Drug|Cohort 2b: Carfilzomib 20 mg/m2|Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 20 mg/m2 on day -2, -1 and + 5
16101901|NCT02148913|Drug|Cohort 3b: Carfilzomib 27 mg/m2|Carfilzomib 20 mg/m2 on days -29, -28, -22, -21, -15, and -14 Bendamustine 120 mg/m2 on day -2 and 100 mg/m2 day -1 Melphalan 140 mg/m2 on day -1 Carfilzomib 27 mg/m2 on day -2, -1 and + 5
16101902|NCT02148874|Biological|influenza virus vaccination|comparison of immune responses to the flu vaccine in obese and non-obese populations
16101903|NCT02148861|Drug|Insulin icodec|Administered once-weekly subcutaneously (s.c., under the skin) for 35 days
16101904|NCT02148861|Drug|insulin degludec|Administered once-daily subcutaneously (s.c., under the skin) for 35 days
16101905|NCT02148861|Drug|placebo|Administered subcutaneously (s.c., under the skin) once-daily for 35 days
16101906|NCT02148848|Drug|Risedronate|Take risedronate 35 mg orally every week
16101907|NCT02148835|Other|Sausage: Triomeg|Commercial sausages enriched with 330 - 510 mg EPA+DHA / 100 g Approximate average composition of active product per 80 g Sausage (Triomeg): 250 mg EPA+DHA as ethyl-ester Energy content 500 kJ (120 kcal), protein 12 g, Carbohydrates 0.8 g, total fat 9 g, of which 2.8 g saturated fatty acids, 4.5 g monounsaturates, 1.4 g polyunsaturates. sodium 0.66 g.
16101908|NCT02148835|Other|Sausage: Control|Control sausage: as active, but no EPA+DHA ethyl-ester.
16101909|NCT02148809|Radiation|1mL of I-131 Human Serum Albumin is injected prior to the measurements|
16101910|NCT02148796|Drug|Broncho-Vaxom (BV)|Active Ingredient: Lyophilised bacterial extract; Chemical Name: OM-85 BV; Strength: 3.5 mg; Excipients: bacterial extract, propyl gallate, sodium glutamate, mannitol, pregelatinised starch, magnesium stearate; Appearance: Blue and white capsule; Dosage Form: 3.5 mg capsule; Manufacturer: OM Pharma, Switzerland (OM stands for Omnia Medicamenta) Storage: Store in the original package
16101911|NCT02148796|Other|Placebo|A placebo capsule will be used that will be indistinguishable from the active study drug.
16101912|NCT02148783|Drug|methylphenidate|This is an open-labeled 4 week methylphenidate administration, 30 mg twice daily by mouth. Placebo and methylphenidate will also be administered as a single dose before one of the two PET and TMS sessions, in a single blinded manner (the participant will not know whether active drug or placebo was administered). PET imaging with [11C]-raclopride, a D2/D3 receptor ligand will be performed after administration of placebo or oral methylphenidate to measure endogenous DA release in TBI patients. Structural MRI will be performed before methylphenidate administration. TMS after placebo or methylphenidate will be performed to measure intracortical inhibition and dopaminergic activity.
16101913|NCT02148783|Drug|Placebo|
16101914|NCT02148770|Device|Neurofeedback|Networks involved in eating behaviour can be modified by neurofeedback training. We will perform a neurofeedback task using the technology of fMRI-based Brain Computer Interface (BCI). BCI approaches based on real-time fMRI (rtfMRI) allow voluntary regulation of brain regions. For the rtfMRI, a well-established setup will be used which translates the blood oxygen level dependent (BOLD) signal of a specific brain region of interest into a visual signal (e.g. moving bar) in real time using brain voyager® and matlab. The study will include 1 training-sessions In the up-regulation condition subjects will learn to up regulate their dlPFC. In the sham-condition subjects are get the same instructions, however they will receive sham feedback.
16101915|NCT02148757|Procedure|Doppler Ultrasound|
16101916|NCT02148744|Biological|XmAb7195|Part 1 and 2: Single IV infusion of XmAb7195 or placebo Part 3: Two-dose sequential IV infusion of XmAb7195 or placebo on Day 1 and Day 8
16101917|NCT02148744|Biological|Placebo|
16101918|NCT02148731|Other|Frailty markers|Brief screening assessment, CGA and frailty markers will be evaluate at inclusion. CGA and frailty markers will be evaluated at 3, 6, 12 and 18 months after the beginning of chemotherapy. Criteria for toxicity and adverse outcomes will be recorded at each cycle or visits
16101919|NCT02148718|Biological|adalimumab|Adalimumab pre-filled syringe, administered by subcutaneous injection
16101920|NCT02148705|Drug|NexoBrid|
16101921|NCT02148705|Procedure|Standard of Care (SOC)|
16101922|NCT02148705|Drug|Gel Vehicle|
16101923|NCT02148692|Procedure|Higher PEEP|
16101924|NCT02148692|Procedure|Lower PEEP|
16101925|NCT02148679|Other|DASH/SRD|Study food for this investigation will be designed and prepared by PurFoods, LLC (Des Moines, IA) dietitians under the direction of Dr. Sam Beattie, Ph. D., and in consultation with research dietitians at the University of Michigan and Columbia University. Study patients randomized to food delivery will select from an available menu of meal options that adhere to nutritional targets as above. Study food will be pre-packaged for storage with preparation (typically microwave heating) to be completed at home by the subject, and will be delivered every 1 to 2 weeks under the direction of PurFoods.
16101926|NCT02148679|Other|Usual care|Standardized advice to restrict dietary sodium intake to < 2000 mg/day
16101927|NCT02148653|Other|Multifunctional diet (MFD)|A mixed diet containing multiple functional foods/concepts with the ability to modulate blood lipid levels, glycemia, insulinemia and prothrombotic status.
16101928|NCT02148653|Other|Control diet|A nutritionally well formulated diet that excludes the functional food items present in the MFD.
16101929|NCT02148640|Drug|Innovator infliximab|
16101930|NCT02148640|Drug|Biosimilar infliximab|
16101931|NCT02148627|Drug|LY3041658 (SC)|Administered SC
16101932|NCT02148627|Drug|LY3041658 (IV)|Administered as slow IV infusion
16101933|NCT02148627|Drug|Placebo|Administered as slow IV infusion
16101934|NCT02148614|Drug|Placebo|Phase 1. Two tablets in a single preprandial dose Phase 2. Two tablets daily for 60 days
16101935|NCT02148614|Drug|Libramed|Phase 1. Two tablets in a single postprandial dose Phase 2. Two tablets daily for 60 days
16101936|NCT02148601|Other|Fecal Microbiota Transplantation|
16101937|NCT02148601|Drug|Standard Antibiotic Therapy|
16101938|NCT02148601|Drug|Vancomycin (before randomization)|Vancomycin will be administered in all patients for 5 days before randomization. Then, patients will be randomized in FMT Group or Standard Antibiotic therapy Group. Patients in the FMT Group will stop vancomycin 24 hours before the fecal microbiota transplantation. Patients in the Standard Antibiotic Therapy Group will continue vancomycin.
16101939|NCT02148588|Drug|Ultrasound-guided peripheral nerve block with 2% lidocaine|"Patients will have a peripheral nerve blockade with a local anesthetic (lidocaine)
~Assessment of spontaneous and evoked pain responses
~Completion of NPSI questionnaire
~Mapping of the affected limb"
16101940|NCT02148575|Behavioral|Self-Management Group|
16101941|NCT02148575|Behavioral|Symptom Management Group|
16101942|NCT02148549|Drug|FIRINOX|FIRINOX regimen by eliminating LV and bolus 5-FU, and irinotecan reduced to 150mg/m2 of 180mg/m2 from FOLFIRINOX regimen.
16101943|NCT02148536|Procedure|Transjugular intrahepatic portosystemic shunt|
16101944|NCT02148523|Behavioral|Comparison to peers|
16101945|NCT02148523|Behavioral|Adherence feedback|
16101946|NCT02148523|Device|Electronic pill bottle|This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial.
16101947|NCT02148510|Device|Monobloc|Construction fitted to upper and lower jaw
16101948|NCT02148510|Device|Bibloc|Biblock construction
16101949|NCT02148497|Procedure|Multi-colored Placido disk imaging|The multi-colored Placido disk instrument records the tear surface using video imaging.
16101950|NCT02148484|Behavioral|Prolonged Exposure for Adolescents|
16101951|NCT02148484|Behavioral|Client Centered Therapy|
16101952|NCT02148458|Other|Mediterranean diet|Mediterranean diet for 8 weeks, followed by 8 weeks of Mediterranean diet with intermittent fasting (i.e. 2 non-consecutive days of fasting per week)
16101953|NCT02148458|Other|Control group|control group eating their usual Western diet for 8 weeks, followed by 8 weeks of usual diet with intermittent fasting (i.e. 2 non-consecutive days of fasting per week).
16101954|NCT02148445|Other|Standard Smoking Cessation|Participants in the standard smoking cessation (SC) arm will receive a standard approach to smoking cessation, including smoking cessation counseling supplemented with 10 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) if they are willing to make a quit attempt.
16102044|NCT02147886|Drug|Cabaletta for IV infusion once weekly during 24 weeks|Cabaletta for IV infusion once weekly
16101955|NCT02148445|Other|Extended Nicotine Replacement Therapy|Participants in the guided maintenance therapy (GMT) arm will receive counseling focused on medication adherence and smoking reduction plus up to 52 weeks of combination nicotine replacement therapy (NRT) (nicotine patch plus choice of gum or lozenge) regardless of their interest in quitting.
16101956|NCT02148445|Drug|Nicotine replacement therapy|
16101957|NCT02148432|Drug|dexmedetomidine infusion rate, 0.5 mcg/kg/hr|continuous infusion of dexmedetomidine at rate of 0.5 mcg/kg/hr
16101958|NCT02148432|Drug|dexmedetomidine infusion rate, 1.0 mcg/kg/hr|continuous infusion of dexmedetomidine at rate of 1.0 mcg/kg/hr
16101959|NCT02148419|Other|no intervention|
16101960|NCT02148406|Behavioral|Yoga Skills Training (YST)|Undergo YST
16101961|NCT02148406|Other|questionnaire administration|Ancillary studies
16101962|NCT02148406|Other|fatigue and depressive symptom assessment and management|Ancillary studies
16101963|NCT02148406|Other|psychological stress assessment|Ancillary studies
16101964|NCT02148406|Other|laboratory biomarker analysis|Correlative studies
16101965|NCT02148406|Other|Attention Control|
16101966|NCT02148393|Procedure|Vitrification with subsequent-cycle embryo thawing/transfer|"The vitrification process will be performed under the same conditions of all other vitrification procedures usually performed in our centre. In summary, vitrification will be accomplished using closed high security straws (CryoBioSystem®) in combination with dimethylsulfoxide, ethylene glycol and sucrose as cryoprotectants (Irvine ScientificR Freeze Kit®).
~In the meantime, patients will wait for a subsequent cycle before starting exogenous hormone therapy for endometrial preparation."
16101967|NCT02148393|Procedure|Intensified luteal phase support for fresh embryo transfer|A single administration of 1500 IU of exogenous hCG (Pregnyl®) 1 hour after oocyte retrieval followed by daily vaginally-administered progesterone 200 mg tid (Utrogestan®) and oestradiol valerate 2 mg bid (Progynova®).
16101968|NCT02148393|Drug|Pregnyl®|1500 IU
16101969|NCT02148393|Drug|Utrogestan®|200 mg tid
16101970|NCT02148393|Drug|Progynova®|2 mg bid
16101971|NCT02148393|Device|CryoBioSystem®|CryoBioSystem® in combination with dimethylsulfoxide, ethylene glycol and sucrose as cryoprotectants (Irvine ScientificR Freeze Kit®) closed in high security straws
16101972|NCT02148380|Drug|pemetrexed plus carboplatin|
16101973|NCT02148380|Drug|gefitinib|
16101974|NCT02148367|Drug|Erythropoietin|"This is a double blind randomized placebo-cotrolled study. Randomization and blinding will be done by the NIH Pharmacy. Participants and study staff will be blinded as to group assignment.Participants randomized into the placebo group will receive placebo once weekly for 4 weeks. In total, 10 participants will be randomized in this group.
~Participants randomized into the experimental group will receive active drug. In total, 20 participants will be randomized in this group. A clinic nurse or physician will administer the study drug, EPO or placebo, to the study participants at the Clinical Center. The study drug is administered by injection under the skin in the arm, leg, or buttock."
16101975|NCT02148354|Behavioral|Smiling is Fun|"Smiling is Fun is an internet-delivered self-help program for emotional disorders, which will allow the individual to learn and practice adaptive ways to cope with depression and daily problems. The program includes eight modules: Motivation for change, Understanding emotional problems; Learning to move on; Learning to enjoy; Learning to live; Living and learning and From now on, what else…?. Furthermore the program uses three transversal tools: 1) Activity report for self-monitoring, whose aim is to provide feedback to the user and help him see that his mood is related to the activities performed, 2) The calendar, and 3) How am I? offers a set of graphs and feedbacks to chart the user's progress."
16101976|NCT02148341|Other|Community of Practice Facilitation|
16101977|NCT02148341|Other|Usual Care|
16101978|NCT02148328|Biological|Trivalent virosomal influenza vaccine|Trivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
16101979|NCT02148328|Biological|Commercial vaccine 1|Trivalent commercial virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
16101980|NCT02148328|Biological|Quadrivalent virosomal influenza vaccine|Quadrivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
16101981|NCT02148328|Biological|Commercial vaccine 2|Quadrivalent commercial influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
16101982|NCT02148315|Behavioral|garden|
16101983|NCT02148302|Device|Harvesting Device (CelluTome©)|Subjects who continue to meet eligibility criteria will be randomized to one of two groups: (1) Up to 3 applications of Epidermal grafting harvested utilizing the CelluTome® system at day zero, week 4 and week 8, visits plus standard of care (multi-layer compression) (2) Multilayer compression alone.
16101984|NCT02148289|Dietary Supplement|Nitrate rich beverage|Following randomisation on day 1, subjects will consume either the nitrate or nitrate-free beverage and then the crossover beverage on day 8.
16101985|NCT02148289|Dietary Supplement|Nitrate free beverage|Following randomisation on day 1, subjects will consume either the nitrate or nitrate-free beverage and then the crossover beverage on day 8.
16101986|NCT02148263|Device|senofilcon A|
16101987|NCT02148250|Drug|U-500 insulin, 100 syringe units|Subjects are randomized to receive 100 syringe units of U-500 insulin. Subjects will receive opposite treatment after 4-8 weeks.
16101988|NCT02148250|Drug|U-500 insulin, 200 syringe units|Subjects are randomized to receive 200 syringe units of U-500 insulin. Subjects will receive opposite treatment after 4-8 weeks.
16101989|NCT02148237|Behavioral|Contingency Management|Participants in this condition will receive usual WIC care in addition to Contingency Management (CM). BF will be determined by direct observation.
16101990|NCT02148211|Other|Data collection|Initial and follow-up data was collected using questionnaires.
16101991|NCT02148198|Dietary Supplement|NWT-03, an egg-white protein hydrolysate|For placebo comparator, a combination of sweetener + aroma, which was equal to the combination used in the intervention period, was given
16101992|NCT02148198|Dietary Supplement|Placebo|A combination of sweetener + aroma, which was equal to the combination used in the intervention period was given as placebo comparator.
16101993|NCT02148185|Drug|MT-1303|
16101994|NCT02148172|Procedure|Standard Plyometric Training|Participants will undergo individualized practice exercises of jumping, hopping, and cutting tasks consistent with standard published exercises.
16101995|NCT02148172|Procedure|Plyometric Training with BWS|Participants will undergo individualized practice exercises of jumping, hopping, and cutting tasks consistent with standard published exercises while their body weight is supported via adjustable harness.
16101996|NCT02148159|Device|Cachexia Acupuncture-A (Peace Classic Needles® )|Acupuncture-A group will receive acupuncture in a pre-determined set of the acupuncture points.
16101997|NCT02148159|Device|General Acupuncture-B (Peace Classic Needles®)|Acupuncture-B group will receive acupuncture in a pre-determined set of the acupuncture points.
16101998|NCT02148146|Drug|Omegaven|Fish oil emulsion given 1g/kg/day as infusion
16101999|NCT02148133|Drug|Eltrombopag 12.5 mg|White, round, film-coated tablets containing 12.5 mg of eltrombopag free acid (SB-497115-GR, eltrombopag) in each tablet
16102000|NCT02148133|Drug|Eltrombopag 25 mg|White, round, film-coated tablets containing 25 mg of eltrombopag free acid (SB-497115-GR, eltrombopag) in each tablet
16102001|NCT02148120|Drug|Beclometasone Dipropionate 100 µg + Formoterol Fumarate 6 µg|
16102002|NCT02148120|Drug|Beclometasone Dipropionate 200 µg + Formoterol Fumarate 6 µg|
16102003|NCT02148120|Drug|Placebo|
16102004|NCT02148107|Drug|BI 691751|BI 691751 Dose 1
16102005|NCT02148107|Drug|BI 691751|BI 691751 Dose 2
16102006|NCT02148107|Drug|BI 691751|BI 691751 Dose 3
16102007|NCT02148107|Drug|BI 691751|BI 691751 Dose 4
16102008|NCT02148107|Drug|BI 691751|BI 691751 Dose 5
16102009|NCT02148107|Drug|BI 691751|BI 691751 Dose 6
16102010|NCT02148107|Drug|Placebo|Placebo
16102011|NCT02148094|Drug|Truvada|The demonstration project will use a prospective cohort design, enrolling individuals and following them up at multiple intervals over the course of 16 months. Study participants will be asked to take one tablet of Truvada daily, as HIV Pre-Exposure Prophylaxis, over this period. They will be asked to attend 7 regular visits at the project sites over the course of the project. In between visits, they will receive peer educator home visits every other day, as part of regular DMSC (Kolkata) and Ashodaya (Mysore/Mandya) outreach prevention activities. We plan to enroll 2000 female sex workers equally split between the two sites.
16102012|NCT02148068|Procedure|Bariatric Surgery|Patients enrolled will undergo either a laparoscopic Roux-en-y Gastric Bypass or laparoscopic Sleeve Gastrectomy. The determination of which operation performed will be made independent of patients' enrollment in the study.
16102013|NCT02148055|Other|Comparaison between MR and autopsy in the macroscopic evaluation of intra uterine death.|
16102014|NCT02148029|Other|Exercise|Upper and Lower extremity exercise
16102015|NCT02148029|Other|Control|Standard care: anticoagulation, compression & ad-lib ambulation
16102016|NCT02148016|Procedure|LSCs and amniotic membrane (Modified Technique)|"Limbal stem cells (LSCs) from the contralateral eye will be harvested and expanded in feeder-free, chemically defined media for one week on a collagen-coated contact lens. The LSCs on contact lens will be transplanted onto a corneal surface in vivo, following removal of scar tissue due to chemical injury or pterygium. The contact lens will then be covered with amniotic membrane to secure it in place.
~The eye will be treated with antibiotics (levofloxacin) and steroids (betamethasone), and then patched."
16102017|NCT02148016|Procedure|Amniotic membrane only (Traditional Technique)|Amniotic membrane alone will be used to cover the corneal surface, after removal of scar tissue from a chemical injury or pterygium.
16102018|NCT02148016|Procedure|PRK, LSCs, and amniotic membrane (Modified Technique)|"Limbal stem cells (LSCs) from the contralateral eye will be harvested and expanded in feeder-free, chemically defined media for one week on a collagen-coated contact lens. The LSCs on contact lens will be transplanted onto a corneal surface in vivo, following photo-refractive keratectomy (PRK). The contact lens will then be covered with amniotic membrane to secure it in place.
~The eye will be treated with antibiotics (levofloxacin) and steroids (betamethasone), and then patched."
16102019|NCT02148016|Procedure|PRK only (Traditional Technique)|PRK alone will be performed.
16102020|NCT02148016|Drug|Levofloxacin|
16102021|NCT02148016|Drug|Betamethasone|
16102022|NCT02148016|Drug|Limbal stem cells (LSCs)|
16102023|NCT02148003|Procedure|RFA at 90 degrees Celsius|Ablation at 90 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 90 degrees Celsius
16102024|NCT02148003|Procedure|RFA at 80 degrees Celsius|Ablation at 80 degrees Celsius is defined as radiofrequency ablation of the lumbar facets nerve supply will be performed at 80 degrees Celsius
16102025|NCT02148003|Device|C-arm guided 20-gauge radiofrequency needle|Needles will be adjusted to optimize sensory and motor stimulation.
16102026|NCT02147990|Drug|Rociletinib|Rociletinib will be administered to patients orally
16102027|NCT02147977|Dietary Supplement|dietary supplement: n-3 PUFA|
16102028|NCT02147977|Dietary Supplement|olive oil|
16102029|NCT02147964|Drug|Testosterone 1% Gel|Testosterone 1% gel 5g daily for 4 months [all subjects]
16102030|NCT02147964|Drug|Acyline|Acyline 300 ug/kg SQ injections every 2-weeks for 4 months [all subjects]
16102031|NCT02147964|Drug|Dutasteride|Dutasteride 2.5 mg (day 1) followed by 0.5 mg daily for 4 months
16102032|NCT02147964|Drug|Ketoconazole|ketoconazole 400 mg PO daily for 4 months
16102033|NCT02147964|Drug|HCG|HCG 60 IU injection Subcutaneously, every other day for 4 months
16102034|NCT02147964|Drug|placebo dutasteride|placebo oral dutasteride PO daily for 4 months
16102035|NCT02147964|Drug|placebo ketoconazole|placebo ketoconazole daily for 4 months
16102036|NCT02147951|Drug|Talimogene Laherparepvec|Up to 4ml of talimogene laherparepvec per cycle visit
16102037|NCT02147938|Drug|Tacrolimus|oral
16102038|NCT02147925|Drug|Liraglutide combined with metformin|Liraglutide, 0.6mg per day for the first week, and will be increased to 1.2mg per day for the second week, and finally 1.8mg per day since the third week
16102039|NCT02147925|Drug|Insulin glargine combined with metformin|The initial dose will be 0.2 unit/kg/d
16102040|NCT02147925|Drug|Sitagliptin combined with metformin|The dose throughout the study will be 100mg per day.
16102041|NCT02147912|Other|Aerobic Exercise|Aerobic exercise intervention consists of lower (treadmill and cyclette) and upper arts (arm ergometer Davenbike®) training, as well as calisthenic exercises with increasing intensity from a minimum of 80% to a maximum workload for lower arts in a minimum time.
16102042|NCT02147899|Drug|SYM-1219|Oral
16102043|NCT02147899|Drug|Placebo|Oral
16102045|NCT02147886|Drug|Cabaletta for IV infusion once weekly during 24 weeks|
16102046|NCT02147873|Drug|birinapant|
16102047|NCT02147873|Drug|Azacitidine|
16102048|NCT02147873|Drug|Placebo|
16102049|NCT02147860|Device|Diabetes Assistant (DiAs) with USS Virginia|DiAs is the central component of our system. It is a standard cell phone running on an Android operating system. The cell phone has been changed to prevent from (1) using it as a phone or browser, (2) changing the volume (3) accidentally shutting it off. The cell phone runs an algorithm and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range and help avoid hypoglycemia during the night.
16102050|NCT02147860|Other|Sensor Augmented Pump Therapy|Subjects randomized to this placebo group will wear a continuous glucose monitoring system (CGM) to measure sensor glucose and a physiological monitor to measure heart rate and 3-axis accelerometer for 24-72 hours.
16102051|NCT02147847|Behavioral|Video game based training 1|32 one-hour, home-based training sessions over 8 weeks
16102052|NCT02147847|Behavioral|Video game based training 2|32 one-hour, home-based training sessions over 8 weeks
16102053|NCT02147834|Drug|Ranolazine|"Ranolazine 500mg tablet
~500mg tablet two times per day for 7 days then,
~500mg tablet (1000mg) two times per day for 15 weeks"
16102054|NCT02147834|Drug|Sugar pill|"sugar pill manufactured to mimic ranolazine 500mg tablet
~500mg tablet two times per day for 7 days then,
~500mg tablet (1000mg) two times per day for 15 weeks"
16102055|NCT02147821|Procedure|No Pleural Chest Tube|
16102056|NCT02147808|Drug|Telotristat etiprate|All subjects will receive two 250 mg telotristat etiprate tablets three times daily.
16102057|NCT02147808|Drug|Midazolam|All subjects will receive 3 mg (1.5 mL oral syrup [2mg/mL]).
16102058|NCT02147769|Device|NIRS monitoring|All enrolled infants will undergo NIRS monitoring of cerebral oxygenation in addition to monitoring of continuous arterial blood pressure.
16102059|NCT02147756|Device|CO2RE|"Subjects will be randomly assigned to three different time-points of laser treatment: immediately, 1 week or 4 weeks prior the scheduled abdominoplasty. Subjects will be required to attend between 2 to 3 visits depending on the interval between the treatment and the abdominoplasty procedure. One side of the abdomen will be treated using the CO2RE device and the other side with the RePair device. The investigator will also leave an untreated area (control).
~Punch biopsies will be obtained before or during the abdominoplasty procedure from the two treated areas (CO2RE and RePair) and one control (un-treated) areas (on the abdominoplasty area) for histological evaluation."
16102060|NCT02147756|Device|Repair|
16102061|NCT02147743|Behavioral|CCP+MDFT|Multidimensional Family Therapy (MDFT; Liddle, 2002) is one of a new generation of multi-systems oriented family-based intervention for adolescent substance abuse and delinquency. It has demonstrated considerable success with juvenile justice youth at various stages of their involvement in the justice system. The model has demonstrated efficacy in reducing substance use and delinquency, increasing the prosocial behaviors (e.g., family functioning, school outcomes) of substance abusing and court involved adolescents.
16102062|NCT02147743|Behavioral|CCP+SAU|Services As Usual community partners will provide individualized mental health counseling and psychiatric services, psychoeducational groups and substance abuse counseling.
16102063|NCT02147730|Procedure|regional anesthesia|all patients receiving a regional anesthesia/analgesia technique
16102064|NCT02147730|Procedure|non-regional anesthesia|all patients receiving other-than-regional anesthesia techniques
16102065|NCT02147717|Device|Laser stimulation|"Infants will be divided in 2 groups:
~Placebo group: Placebo (fake laser stimulation) plus opioid treatment before ETS
~Experimental group: Laser stimulation plus opioid treatment before ETS. Low level laser acupuncture, 670 nm, 10Hz, 0,3 J per acupoint, 6 points per neonate (Zu san li, He Gu, Nei Guan) marquage CE, premio 30 laser duo de Sedatelec. Overall 3 minutes of treatment.
~This sequence will be repeated 4 times during the study (1 hour before surgery and every 12 hours after surgery)"
16102066|NCT02147717|Device|Fake laser stimulation|newborns have the same preparation procedure as the intervention to put them under the same conditions group. The laser pen is turned off, off-voltage
16102067|NCT02147704|Dietary Supplement|High-sodium diet|"One of high- or low sodium intake for 7 days during each period
~High sodium intake: 50 mmol/day by diet + 250 mmol/day by salt tablets"
16102068|NCT02147704|Dietary Supplement|low-sodium diet|"One of high- or low sodium intake for 7 days during each period
~Low sodium intake : 50 mmol/day by diet"
16102069|NCT02147691|Drug|Azelaic acid 15%|Applied to the face each AM and PM
16102070|NCT02147691|Drug|Brimonidine 0.33%|Applied to the face each AM 30 minutes after the application of Azelaic acid 15%
16102071|NCT02147678|Drug|Etomidate|
16102072|NCT02147678|Drug|Propofol|
16102073|NCT02147678|Drug|Remifentanil|During anesthesia maintenance, all patients will be given remifentanil at the speed of 0.2~0.4 μg/kg/min.
16102074|NCT02147678|Drug|Anesthesia induction|For all patients, the induction protocol is midazolam 0.1 mg/kg, sufentanil 0.3 μg/kg, cisatracurium 0.15 mg/kg.
16102075|NCT02147665|Other|Hookah smoking|Subjects will smoke waterpipe in a controlled research environment.
16102076|NCT02147652|Other|Personalized music|
16102077|NCT02147639|Dietary Supplement|Sodium Nitrate|
16102078|NCT02147639|Dietary Supplement|Sodium Nitrate - double dose|
16102079|NCT02147639|Dietary Supplement|Placebo|
16102080|NCT02147639|Procedure|Increased exercise intensity|
16102081|NCT02147626|Behavioral|Web-based educational and motivational modules|
16102082|NCT02147626|Behavioral|Information and Screening Group|
16102083|NCT02147613|Other|High intensity interval training|3 days per week at 85-90% peak heart rate (4x4 bouts) for 1 month (12 sessions of exercise)
16102084|NCT02147613|Other|Moderate intensity exercise training|3 days/week, 30 mins at 70% Peak heart rate for 1 month (12 sessions of exercise)
16102085|NCT02147587|Drug|Tofacitinib|5 mg twice daily of tofacitinib with background methotrexate for 12 weeks
16102086|NCT02147587|Drug|Placebo|Placebo tablets twice daily with background methotrexate for 12 weeks
16102137|NCT02147054|Drug|Rocuronium|
16102138|NCT02147054|Drug|Sugammadex|Effect of Rocuronium will be reversed at the appropriate time using Sugammadex 16mg/kg as a single dose which may be repeated once.
16102139|NCT02147041|Drug|EGCG(Epigallocatechin Gallate)|500mg, three times a day, duration:12 weeks
16102140|NCT02147041|Drug|Placebo|
16102087|NCT02147574|Procedure|Anti-peristaltic ileosigmoid anastomosis|1,Laparoscope Sub-total Colectomy： After the entire colon mobilization,the ileum is resected at 10cm from ileocecum and 10-15cm colon up to peritoneal reflection is reserved. The ileocolic artery should be reserved carefully.2, Intestinal tract reconstruction: The terminal ileum is turned over 180°in anti-clockwise direction along the superior mesenteric vein long axis. To avoid the small mesenteric torsion , we should turn the broken edge towards inside. The terminal ileum and 10-15cm colon anastomose in anti-peristaltic direction,the anastomotic length is 8-10 cm.3, Sewn the space between anastomotic Intestine and posterior peritoneum. A drain is placed in the abdominal cavity and another one is placed in anal canal.
16102088|NCT02147561|Biological|botulinum toxin Type A|Botulinum toxin Type A injected across specific head and neck muscles on Day 0.
16102089|NCT02147548|Drug|etifoxine|
16102090|NCT02147548|Drug|lorazepam|
16102091|NCT02147548|Drug|Placebo|
16102092|NCT02147535|Drug|Methylphenidate|10 mg as a single dose followed by one blood sample 3 hours post-dose
16102093|NCT02147522|Behavioral|Self-care management|AHH behavioral intervention is provided by promotoras
16102094|NCT02147509|Drug|0.02% Fm, SH|Sjogren's Syndrome patients with severe dry eye
16102095|NCT02147509|Drug|0.02% Fm, SH, 0.05% CsA|Sjogren's Syndrome patients with severe dry eye
16102096|NCT02147509|Other|0.02% Fm, SH, tBCL|Sjogren's Syndrome patients with severe dry eye
16102097|NCT02147509|Drug|0.02% Fm, SH, AS|Sjogren's Syndrome patients with severe dry eye
16102098|NCT02147496|Other|Dietary Intervention|
16102099|NCT02147483|Behavioral|Mindfulness Based Relapse Prevention|Mindfulness based relapse prevention therapy provided over eight sessions in person to prevent alcohol relapse.
16102100|NCT02147483|Behavioral|Treatment as usual|Treatment usually provided by clinician
16102101|NCT02147470|Drug|Definity ultrasound contrast agent|All subjects will undergo CEUS of the kidney at baseline to measure renal blood flow. This procedure will be repeated after volume expansion and if indicated, once again after treatment with albumin, midodrine and octreotide.
16102102|NCT02147431|Drug|semaglutide|"2 periods of 12 weeks of once weekly dosing with multiple doses of semaglutide, for subcutaneous (s.c., under the skin) injection, escalated up to 1.0 mg semaglutide.
~Each treatment period will be followed by a hypoglycaemic clamp"
16102103|NCT02147431|Drug|placebo|"2 periods of 12 weeks of once weekly dosing, subcutaneous (s.c., under the skin) injection.
~Each treatment period will be followed by a hypoglycaemic clamp."
16102104|NCT02147392|Drug|[11C]ER-176|
16102105|NCT02147379|Drug|Lurasidone|
16102106|NCT02147366|Behavioral|Music & lifestyle changes|Music intervention involved listening to raga bhimpalas played on bansuri/flute (an Indian instrument) for 15 minutes daily for 3 months.
16102107|NCT02147366|Behavioral|Lifestyle|Lifestyle intervention was based on Joint national committee VII guidelines for hypertension
16102108|NCT02147353|Drug|Sinecatechins 15% Ointment|Following cryotherapy, half of the subjects will be randomized to treatment with sinecatechins ointment twice daily starting one week after cryotherapy (Week 1).
16102109|NCT02147353|Drug|Cryotherapy alone|Cryotherapy will be standardized in all subjects and for all treated lesions.
16102110|NCT02147301|Device|LC Bead|"Doxorubicin Eluting Bead Transarterial Chemoembolization (DEB-TACE):
~Doxorubicin-loaded LC Beads® are administered via a co-axially placed commercially available hepatic artery catheter into hepatic arteries targeted for treatment. Procedure is performed under direct fluoroscopic visualization until stasis of arterial flow is achieved or until a total of 4 ml of microspheres have been administered, whichever occurs first."
16102111|NCT02147288|Device|Renasys*GO Negative Pressure Wound Therapy System|Continuous, mechanical negative pressure wound therapy applied to drain in the immediate post-operative period (vs standard, closed-suction JP drains).
16102112|NCT02147262|Drug|doxycycline orally, 100 mg, bid, 14 days|
16102113|NCT02147262|Drug|doxycycline orally, 100 mg, bid, 28 days|
16102114|NCT02147249|Drug|antibiotic treatment|Patient will be treated with: doxycycline orally, 100 mg, bid, 14 days or cefuroxime axetil orally, 500 mg, bid, 14 days or amoxicillin orally, 500 mg, tid, 14 days
16102115|NCT02147236|Behavioral|Social Skills Training|
16102116|NCT02147223|Dietary Supplement|Flavanol rich intervention|Flavanol intervention products (250 mg, 500 mg and 750 mg flavanols)
16102117|NCT02147223|Dietary Supplement|Flavanol free intervention|Calorically, micro- and macronutrient matched control product free of flavanols
16102118|NCT02147210|Other|biological analysis|
16102119|NCT02147197|Drug|Ulipristal acetate (UPA)|UPA tablet
16102120|NCT02147197|Drug|Placebo|Matching placebo tablet.
16102121|NCT02147171|Dietary Supplement|VisionAce|
16102122|NCT02147171|Dietary Supplement|Placebo|
16102123|NCT02147158|Drug|Ulipristal acetate (UPA)|Ulipristal acetate (UPA) tablet.
16102124|NCT02147158|Drug|Placebo|Matching placebo tablet.
16102125|NCT02147132|Drug|Nicotine Nasal Spray|7 days. 1 mg/dose, up to 40x/day.
16102126|NCT02147132|Drug|Varenicline|14 days. Days 1-3: 0.5 mg once daily; Days 4-7: 0.5 mg twice daily; Days 8-14: 1 mg twice daily.
16102127|NCT02147132|Drug|Placebo Nasal Spray|7 days. 1 mg/dose, up to 40x/day.1 mg/dose, up to 40x/day. This will appear similar to the Nicotine Nasal Spray, but will be a placebo.
16102128|NCT02147132|Drug|Placebo Varenicline|14 days. Days 1-3: 0.5 mg once daily; Days 4-7: 0.5 mg twice daily; Days 8-14: 1 mg twice daily. This will appear identical to the drug Varenicline, but will be a placebo.
16102129|NCT02147119|Procedure|Coronary angiography|
16102130|NCT02147106|Other|Videoconsultation|
16102131|NCT02147093|Device|Test (multi-focal)|contact lens was to be worn a daily wear.
16102132|NCT02147093|Device|Control (Sphere)|contact lens was to be worn a daily wear with spectacles
16102133|NCT02147080|Behavioral|UV4me|Tailored website includes: personalized responses to quizzes, information on skin type and burn risk, UV damage photo of similar individual, avatar activity, age progression images, personal risk calculator, SPF (sun protection factor) calculator
16102134|NCT02147080|Behavioral|Skin Cancer Foundation website|Current best practice website for skin cancer and prevention. Includes information, images, news, and opportunities for advocacy.
16102135|NCT02147067|Drug|Ranolazine|Ranolazine 1,000 mg twice daily
16102136|NCT02147067|Drug|Placebo|Placebo
16102141|NCT02147028|Radiation|Hippocampal sparing whole brain radiotherapy|30 Gy in 10 fractions hippocampal sparing whole brain radiotherapy will be administered by Helical Tomotherapy, IMRT, or VMAT
16102142|NCT02147028|Radiation|Conventional whole brain radiotherapy|30 Gy in 10 fractions conventional whole brain radiotherapy will be administered
16102143|NCT02147015|Drug|Glucocorticoids|
16102144|NCT02147015|Drug|Antibiotics|
16102145|NCT02147015|Drug|Inhaled corticosteroid (ICS)|
16102146|NCT02147015|Drug|Long-Acting Muscarinic Antagonists(LAMA)|
16102147|NCT02147015|Drug|Short-acting beta2-agonist (SABA)|
16102148|NCT02147015|Other|Physical treatments|
16102149|NCT02147015|Drug|long-acting beta2-agonist (LABA)|
16102150|NCT02147002|Dietary Supplement|Gold omega 3|At the beginning and at the end of the observation period, besides the clinical test, some other tests will be carried out: echocardiography, pulse wave velocity (PWV), ambulatory blood pressure monitoring (ABPM). Blood will be collected for laboratory tests such as: lipid profile, uric acid, CRP, BUN, creatinine, morphology, Ca, P, Ca x P, ionogram, xanthine oxidase, MPC1,Omega-3 acids, resolvin and protectins - the metabolites of Omega-3 acids, creatinine excretion, MPC1 excretion and excretion of uric acid.The patients will be treated with Omega-3 acids as a Gold Omega 3 preparation (2x1 capsule where 1 capsule = 1000 mg) for 6 months.
16102151|NCT02146989|Other|reproducibility of upper extremity strength measurements|inter-rater reliability and test-retest reliability
16102152|NCT02146976|Drug|propofol|introvenious infusion of propofol
16102153|NCT02146976|Drug|sevoflurane|sevoflurane (1.0-1.3 Minimum Alveolar Concentration)
16102154|NCT02146937|Drug|Bicalutamide plus Finasteride- Combination therapy|3-month (90-day) course of bicalutamide 50 mg by mouth daily and finasteride 5 mg by mouth daily
16102155|NCT02146924|Biological|CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T-lymphocytes|Given IV
16102156|NCT02146924|Biological|CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes|Given IV
16102157|NCT02146924|Other|Laboratory Biomarker Analysis|Correlative studies
16102158|NCT02146911|Drug|Bupropion|
16102159|NCT02146911|Drug|Varenicline|
16102160|NCT02146911|Behavioral|Weekly Motivational Emails|The e-mails will include tips on several things other than the medications that participants can do to help them quit smoking. The contents of the emails will vary from week to week. The e-mails will provide tips on ways to create an atmosphere that promotes quitting and staying abstinence. They will also include recommendations on how to address issues with withdrawal symptoms and cravings. In addition, they will provide positive motivational messages by stating facts on benefits of quitting smoking.
16102161|NCT02146898|Other|Position|
16102162|NCT02146885|Other|Weight Control|Weight Control
16102163|NCT02146846|Drug|Imatinib|Patients with chronic myeloid leukemia who receive Imatinib as treatment
16102164|NCT02146833|Drug|Selinexor|Comparison of different dosages and dosing schedules of drug.
16102165|NCT02146820|Device|GentleMax system|Picosecond Laser System for the Treatment of Pigmented Lesions
16102166|NCT02146807|Device|Picosecond Laser system|Picosecond Laser System for the Treatment of Unwanted Tattoos
16102167|NCT02146794|Device|Renal denervation|Renal denervation
16102168|NCT02146781|Biological|CryJ2-DNA-LAMP plasmid vaccine by intradermal injection|"Immunomic Therapeutics Inc. CryJ2-DNA-LAMP vaccine is a frozen product formulated in physiological saline and contains no preservative. The study product is packaged in a 1 ml volume in a 3 ml glass vial, with label complying with FDA requirements.
~Subjects will receive CryJ2-DNA-LAMP plasmid vaccine by intradermal injection using the Biojector 2000 devibe."
16102169|NCT02146781|Other|Saline Control|The subjects in Cohort 1 will receive four doses of saline control 14 days apart, beginning Day 0. Each dose will be delivered as four separate injections of 0.200 mL volumes administered Intradermally (ID) using the needless Biojector 2000 device in separate skin sites. The use of the four 0.200 mL volumes is necessitated in order to compare the skin test sites to the number of sites in Cohorts 2 (4 sites per dose) and Cohort 3 (2 sites per dose). The multiple intradermal administration sites per dose are because of the dilute vaccine material (2.7 mg/mL).
16102170|NCT02146742|Drug|ASP1707|oral
16102171|NCT02146742|Drug|Placebo|oral
16102172|NCT02146729|Procedure|Percutaneous Pedicle Screw Fixation|Percutaneous Pedicle Screw Fixation
16102173|NCT02146729|Procedure|Open Treatment|Midline posterior incision with instrumentation.
16102174|NCT02146716|Other|Energetic Resonance by Cutaneous Stimulation|Energetic Resonance by Cutaneous Stimulation (RESC) is a non-invasive method based on energetic Chinese medicine principles and digital contact. RESC is characterized by echo phenomena between two stimulation points.
16102175|NCT02146703|Drug|Gemcitabine, and S-1|"Treatment will be delivered as a 3-week cycle.
~Gemcitabine 1000 mg/m2 iv on day 1, 8
~S-1 60 mg/day po on day 1-14"
16102176|NCT02146690|Other|osteopathic manipulative treatment|
16102177|NCT02146690|Other|sham therapy|
16102178|NCT02146690|Other|usual care|
16102179|NCT02146677|Other|Osteopathic manipulative treatment|
16102180|NCT02146677|Other|Sham therapy|
16102181|NCT02146677|Other|Usual care|
16102182|NCT02146664|Drug|DLBS1033|Investigational drug or placebo will be given in addition to the standard therapy which consists of: aspirin enteric-coated tablet 1 x 160 mg (two tablets @ 80 mg) and clopidogrel film-coated tablet 1 x 75 mg daily for eight weeks. Standard therapy alone will still be given afterwards, for another sixteen weeks
16102183|NCT02146664|Drug|Placebo|Investigational drug or placebo will be given in addition to the standard therapy which consists of: aspirin enteric-coated tablet 1 x 160 mg (two tablets @ 80 mg) and clopidogrel film-coated tablet 1 x 75 mg daily for eight weeks. Standard therapy alone will still be given afterwards, for another sixteen weeks
16102184|NCT02146651|Drug|BioChaperone insulin lispro 0.2U/Kg|Single dose of 0.2U/Kg body weight injected subcutaneously
16102185|NCT02146651|Drug|BioChaperone insulin lispro 0.1U/Kg|Single dose of 0.1U/Kg body weight injected subcutaneously
16102186|NCT02146651|Drug|BioChaperone insulin lispro 0.4U/Kg|Single dose of 0.4U/Kg body weight injected subcutaneously
16102187|NCT02146651|Drug|Humalog®|Single dose of 0.2U/Kg body weight injected subcutaneously
16102188|NCT02146638|Drug|Morphine|
16102189|NCT02146638|Drug|Fentanyl|
16102190|NCT02146625|Drug|CJ-40002|
16102191|NCT02146612|Other|Amino Acid Supplement Group|Group receiving nutritional supplement
16102192|NCT02146599|Other|Administration of patient self-assessment|
16102193|NCT02146573|Behavioral|Continuity Care Intensivist Communication Training|Physicians enrolled in the intervention arm will complete a two to three part communication training. Survey measures of communication competency and burnout will be administered at baseline, after training, and at the end of the study. After the communication training, physicians will undergo an OSCE assessment with a simulated patient to evaluate communication skills. At the end of the study, CCI providers will receive surveys that assess the experience and challenges of the role, repeat surveys assessing competency with communication and frequency of engaging families in goals of care conversations, in addition to a follow-up focus group that will assess their experience with the intervention, the time required and the potential tradeoffs in other duties required by them to participate as a CCI.
16102194|NCT02146573|Behavioral|Continuity Care Intensivist (CCI) Provider Program|"After undergoing CCI training, CCI providers will fulfill a standardized role with parent-patient dyads:
~CCI will meet with families on a regular basis and at change of physician of record throughout their entire PICU hospitalization.
~Help patients/families navigate decisions in concert with preferences and beliefs
~Help patients/families and other care providers look at bigger picture; trajectory of illness, goals, and hopes for the patient.
~Serve as point person for active intensivists on service and other specialists
~Help resolve conflict when multiple providers have different opinions on course of action"
16102195|NCT02146547|Drug|Aripiprazole|Administration in once-a-day schedule without regard to meals.
16102196|NCT02146547|Drug|Aripiprazole depot|Abilify Maintena is an intramuscular (IM) depot formulation of oral aripiprazole. It provides the efficacy and safety profile of oral aripiprazole in a once-monthly injection.
16102197|NCT02146547|Drug|Paliperidone|Administration once a day orally standardised in relation to food intake.
16102198|NCT02146547|Drug|Paliperidone palmitate|In selected patients with schizophrenia and previous responsiveness to oral paliperidone or risperidone, Xeplion may be used without prior stabilization with oral treatment if psychotic symptoms are mild to moderate and a long-acting injectable is needed.
16102199|NCT02146534|Drug|extended release fampridine|pts will receive Fampyra 10 mg BID PO for the duration of the study
16102200|NCT02146534|Drug|Placebo|placebo will be taken PO BID
16102201|NCT02146508|Procedure|Endoscopic Mucosal Resection (EMR)|Endoscopic removal of regions of ESD.
16102202|NCT02146508|Device|Radiofrequency ablation|Endoscopic radiofrequency ablation of regions of ESD
16102203|NCT02146495|Device|EEG-NF|
16102204|NCT02146482|Other|Sit-stand computer workstation|A sit-stand computer workstation allows one to sit or stand throughout the day while maintaining continued use of one's computer.
16102205|NCT02146469|Biological|2 doses with an 3 months interval|varicella vaccination
16102206|NCT02146469|Biological|A second dose with an 1 year interval|varicella vaccine
16102207|NCT02146469|Biological|A second dose with an 3 year interval|varicella vaccine
16102208|NCT02146469|Biological|A second dose with an 5 year interval|varicella vaccine
16102209|NCT02146469|Biological|1 dose Varicella vaccine and 1 dose MMR given at the same time|varicella vaccine and MMR
16102210|NCT02146469|Biological|1 dose MMR|MMR
16102211|NCT02146456|Drug|Tranexamic Acid|
16102212|NCT02146443|Other|Stretched arm test|Measurement of static arm strength. Test subject is asked to hold a 2.5 kg weight in their dominant arm fully extended at 90-degree flexion and 15-degree abduction as long as possible without moving.
16102213|NCT02146443|Other|Stress|During completion of the star shaped manual dexterity test, the test subject is asked to identify cards from a regular deck of playing card by naming the suit and rank of the card. They will be asked to identify one random card during each of the 10 rounds in the completion of the test
16102214|NCT02146443|Device|Star shaped manual dexterity test|On a piece of wood, a piece of metal (dimensions 22 cm x 22 cm) is mounted. In the center of the metal plate, is a star shaped track. The star has 6 points and the track is 9 mm wide. It measures 15,3 cm from the tips of opposing arms of the star. With a surgical scissor in his dominant hand, the test subject is instructed to follow the star shaped track ten times, five times clockwise and five times counter clockwise. Contact with the border of the track is counted as an error. A computer software program automatically registers completion time and number of errors. The test is conducted in an undisturbed environment.
16102215|NCT02146430|Drug|DS-5565|DS-5565 15 mg tablet for oral administration
16102216|NCT02146430|Drug|Pregabalin|Pregabalin 150 mg capsule for oral administration
16102217|NCT02146430|Drug|Placebo tablet|Placebo tablet (matching DS-5565) for oral administration
16102218|NCT02146430|Drug|Placebo capsule|Placebo capsule (matching pregabalin) for oral administration
16102219|NCT02146417|Procedure|Low pressure pneumoperitoneum|
16102220|NCT02146417|Procedure|Normal pressure pneumoperitoneum (12 mmHg)|
16102221|NCT02146417|Procedure|Deep neuromuscular block|
16102222|NCT02146404|Other|hypoglycemia|Blood glucose levels will be kept at ~3.0 mmol/l
16102223|NCT02146404|Other|euglycemia|Blood glucose levels will be kept at ~5.0 mmol/l
16102224|NCT02146391|Drug|Androxal 25 mg Capsules|
16102225|NCT02146378|Drug|Vyndaqel|20mg/day
16102226|NCT02146352|Device|AXIOS Stent with Electrocautery Enhanced Delivery System|Endoscopy with ultrasonography to implant AXIOS stent using electrocautery enhanced delivery system to allow drainage of pancreatic pseudocyst. Removal of AXIOS stent after 30 or 60 days.
16102227|NCT02146339|Other|Cheese n°1- cheese n°2 - cheese n°3|"Each subject will receive a single dose of cheese n°1, then cheese n°2 after a wash-out period of 4 weeks, then cheese n°3 after a wash-out period of 4 weeks.
~Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product"
16102228|NCT02146339|Other|Cheese n°1- cheese n°3 - cheese n°2|"Each subject will receive a single dose of cheese n°1, then cheese n°3 after a wash-out period of 4 weeks, then cheese n°2 after a wash-out period of 4 weeks.
~Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product"
16102264|NCT02146092|Procedure|Incentive spirometry|
16102265|NCT02146092|Other|Physiotherapy|Standard of care exercise training and supervision
16102229|NCT02146339|Other|cheese n°2 - cheese n°1- cheese n°3|"Each subject will receive a single dose of cheese n°2, then cheese n°1 after a wash-out period of 4 weeks, then cheese n°3 after a wash-out period of 4 weeks.
~Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product"
16102230|NCT02146339|Other|Cheese n°2- cheese n°3 - cheese n°1|"Each subject will receive a single dose of cheese n°2, then cheese n°3 after a wash-out period of 4 weeks, then cheese n°1 after a wash-out period of 4 weeks.
~Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product"
16102231|NCT02146339|Other|Cheese n°3 - cheese n°1- cheese n°2|"Each subject will receive a single dose of cheese n°3, then cheese n°1 after a wash-out period of 4 weeks, then cheese n°2 after a wash-out period of 4 weeks.
~Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product"
16102232|NCT02146339|Other|Cheese n°3- cheese n°2 - cheese n°1|"Each subject will receive a single dose of cheese n°3, then cheese n°2 after a wash-out period of 4 weeks, then cheese n°1 after a wash-out period of 4 weeks.
~Cheese n°1 = unfortified cheese product Cheese n°2 = 3 g milk polar lipid fortified cheese product Cheese n°3 = 5 g milk polar lipid fortified cheese product"
16102233|NCT02146326|Behavioral|Motivational Interviewing (MI)|MI is a common counseling technique. It was offered as an 8-9 hour workshop across 3 sessions to mental health agency staff who were randomly assigned to MI. Each session occurred approximately one month apart.
16102234|NCT02146326|Behavioral|Burnout Reduction: Enhanced Awareness, Tools, Handouts, and Education (BREATHE)|BREATHE is a program developed to attempt to improve or prevent the symptoms of burnout. It was offered as an 8-9 hour workshop across 3 sessions to mental health agency staff who were randomly assigned to BREATHE. Each session occurred approximately one month apart.
16102235|NCT02146313|Drug|DMUC4064A|Participants will receive escalated DMUC4064A dose or RP2D, as a single agent by intravenous (IV) infusion q3w on Day 1 of each cycle (21 days).
16102236|NCT02146300|Biological|1. session birch pollen nasal exposure 2. session xylometazoline nasal exposure|Aquagen SQ 10 000 SQ/ml nasal exposure Xylometazoline 1 mg/ml nasal exposure
16102237|NCT02146287|Other|Cycled Light|"Cycled light was provided in an 11-hour-on, 11-hour-off pattern. Daylight (240-700 lux) was provided with the incubator cover folded on top of the incubator allowing light in from four sides, or with the bassinet cover off during day hours (0730-1830). With the daylight range of 240-700 lux and limited access to natural light, excessive daylight was prevented.
~Continuous near darkness was provided as (5-30 lux) throughout the day except from 0630-0730 and 1830-1930, when lighting levels varied based on nursing care needs at the change of shift. Near-darkness (5-30 lux) was provided by using incubator (totally covered or with the front flap back) and bassinet covers, and dimming individual bedside light during the day (0730-1830) and night hours (1930-0630)."
16102238|NCT02146261|Drug|E6011|Subcutaneous administration of E6011 (at doses of 50, 100, 200 and 400 mg)
16102239|NCT02146261|Drug|Placebo|Subcutaneous administration of placebo
16102240|NCT02146248|Drug|combined oral contraceptive|combined oral contraceptive pill will be dosed continuously for 30 days without cycle interruption
16102241|NCT02146248|Drug|DepoProvera|injectable hormonal contraceptive
16102242|NCT02146235|Behavioral|Psycho-Music Therapy|
16102243|NCT02146222|Drug|VEGFR/PDGFR dual kinase inhibitor X-82|Given PO
16102244|NCT02146222|Drug|docetaxel|Given IV
16102245|NCT02146222|Other|fluorine F 18 fluorothymidine|Undergo FLT PET/CT
16102246|NCT02146222|Procedure|positron emission tomography/computed tomography|Undergo FLT PET/CT
16102247|NCT02146222|Other|pharmacological study|Correlative studies
16102248|NCT02146222|Other|laboratory biomarker analysis|Correlative studies
16102249|NCT02146209|Drug|Metronidazole benzoate|Single oral dose of 400 mg
16102250|NCT02146209|Drug|Flagyl 125 mg/5 ml oral suspension|Single oral dose of 500 mg (20 ml suspension)
16102251|NCT02146209|Drug|Flagyl 400 mg Tablets|Single oral dose of 400 mg
16102252|NCT02146196|Device|4 weeks robotic assisted training with the Lokomat®|During a prespecified time period (4weeks) a three times weekly robotic assisted gait training during 30-45 minutes. Strength training, interval training and endurance training are possible.
16102253|NCT02146196|Device|One week robotic assisted gait training with the Lokomat®|During a prespecified time period (1week) a three times weekly robotic assisted gait training during 10-40 minutes. Strength training, interval training and endurance training are possible
16102254|NCT02146183|Dietary Supplement|Carbohydrate steviol glycosides|To investigate if intake of stevioside in addition to a carbohydrate-containing composition after work related depletion of muscle glycogen will increase the rate of glycogen re-synthesis as compared with intake of the carbohydrate-containing composition alone.
16102255|NCT02146183|Dietary Supplement|Placebo Corn Starch|500 mg/day
16102256|NCT02146157|Dietary Supplement|herb and mineral combination product|herb and mineral product containing cinnamon, turmeric and holy basil
16102257|NCT02146157|Dietary Supplement|Placebo|Placebo of herb and mineral product containing cinnamon, turmeric and holy basil
16102258|NCT02146144|Procedure|ILM Peeling|"common surgical procedure:
~For phakic eyes with cataract • phacoemulsification and implantation of a posterior chamber intraocular lens
~For all patients:
~Central and peripheral 25 Gauge vitrectomy
~dissection of the epimacular membrane
~injection of Membraneblue-Dual® according to protocol, wait of 1 minute with the infusion line closed, and then suction of surplus and washing of the vitreous cavity
~Intraoperative picture to see the possible spontaneous ILM peeling
~If no spontaneous ILM peeling, the patient will be randomized at the operating block
~Specific surgical procedure:
~• • Randomization into two groups:
~Arm 1: no peeling, where the ILM peeling will not be made
~Arm 2: active peeling, where the ILM peeling will be made"
16102259|NCT02146131|Device|Standard FB with fluoroscopy|Technique used, to go through the patient's airway, locate and obtain samples from pulmonary lesions
16102260|NCT02146131|Device|R-EBUS with ultrathin bronchoscope|Technique used to go through the patient's airway and using radial ultrasound, locate and obtain samples from pulmonary lesions
16102261|NCT02146118|Drug|Erlotinib|Erlotinib 150 mg/day q 4 weeks
16102262|NCT02146118|Dietary Supplement|Silybin-phytosome|Silybin-phytosome 1g bid/day q 4 weeks
16102263|NCT02146105|Other|Yoga For Knee Osteoarthritis|Yoga program specifically for women with knee osteoarthritis.
16102266|NCT02146079|Drug|semaglutide|Subjects will be randomised to receive either semaglutide 0.5 mg, semaglutide 0.5 mg placebo, semaglutide 1.0 mg or semaglutide 1.0 mg placebo within each group. Treatment with active drug or placebo blinded within each dose level. After randomisation, the subjects will follow a fixed dose escalation. The maintenance dose of 0.5 mg will be reached after 4 weeks of 0.25 mg. The maintenance dose of 1.0 mg will be reached after 8 weeks (4 weeks) of 0.25 mg and 4 weeks of 0.5 mg). Once-weekly subcutaneous (s.c., under the skin) administration. Trial duration per subject is 18 to 21 weeks depending on the individual subject's schedule
16102267|NCT02146079|Drug|placebo|Subjects will be randomised to receive either semaglutide 0.5 mg, semaglutide 0.5 mg placebo, semaglutide 1.0 mg or semaglutide 1.0 mg placebo within each group. Treatment with active drug or placebo blinded within each dose level. After randomisation, the subjects will follow a fixed dose escalation. The maintenance dose of 0.5 mg will be reached after 4 weeks of 0.25 mg. The maintenance dose of 1.0 mg will be reached after 8 weeks (4 weeks) of 0.25 mg and 4 weeks of 0.5 mg). Once-weekly subcutaneous (s.c., under the skin) administration. Trial duration per subject is 18 to 21 weeks depending on the individual subject's schedule.
16102268|NCT02146066|Biological|DCVax-L|Autologous Dendritic Cells Pulsed with Tumor Lysate Antigen
16102269|NCT02146053|Dietary Supplement|ferrous sulfate|ferrous sulphate (200 mg capsules containing 65 mg of iron) to be taken at mealtimes twice daily for 7 days during the treatment period.
16102270|NCT02146053|Dietary Supplement|Placebo|placebo capsules: methyl cellulose
16102271|NCT02146027|Dietary Supplement|Fermented Milk Drink Yakult 40|Lactobacillus casei Shirota, with 40 billion bacteria per 80 g (concentration of 5 x 10^8 CFU/g). Intervention will be used for 12 weeks.
16102272|NCT02146027|Dietary Supplement|Fermented Milk Drink Yakult 40|Ingredients: Skimmed milk and/or Reconstituted Skimmed Milk, Sugar, Glucose, Live Lactic Bacteria (Lactobacillus casei Shirota) 40 billions per 80 g - concentration of 5 x 108 CFU/g), Flavour. Gluten Free.
16102273|NCT02146014|Other|Placebo|"Transcranial Direct Current Stimulation (tDCS) is a procedure that uses a small battery-driven unit to deliver weak electrical currents (1-2 mA) through the intact scalp. The procedure is painless and is thought to modulate the excitability of the underlying cerebral tissue for hours or days after sessions.
~In the placebo group the current will be off."
16102274|NCT02146014|Device|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation (tDCS) is a procedure that uses a small battery-driven unit to deliver weak electrical currents (1-2 mA) through the intact scalp. The procedure is painless and is thought to modulate the excitability of the underlying cerebral tissue for hours or days after sessions.
16102275|NCT02146001|Other|Reducing sedentary behavior group|This intervention will use individual counseling and the the BodyMedia armband to self-monitor sedentary behavior. The goal will be to decrease time spent in sedentary behavior by 60 minutes each day.
16102276|NCT02146001|Other|Moderate-to-vigorous activity group|This group will be administered an individual, behavioral intervention using the BodyMedia armband to self-monitor physical activity. The prescription will be 150 minutes of moderate exercise (e.g. brisk walking) each week.
16102277|NCT02145988|Drug|DLBS1033|Investigational drug or placebo will be given in addition to the standard therapy: aspirin at the dose of 80 mg, once daily, every day for twelve weeks of study period
16102278|NCT02145988|Drug|Placebo|Investigational drug or placebo will be given in addition to the standard therapy: aspirin at the dose of 80 mg, once daily, every day for twelve weeks of study period
16102279|NCT02145975|Drug|Fentanyl|The nurse will administer 1 ug per kg during 5 seconds when the patient complain of pain (visual analog scale, VAS, ≥7). Immediately with the onset of drug administration a timer started; every 5 minutes the researcher assess the EVA and the drug will be administered if VAS > 3, until the patient manifests as a lower pain VAS ≤ 3 (mild). The nurse in charge in the PACU will manage the drug and will take 100 ug of fentanyl which is diluted in 10 mL of normal saline leaving a 10μg per ml concentration, are not labeled and for the physical and chemical characteristics of both drugs (colorless) risks of unblinded is minimized.
16102280|NCT02145975|Drug|Morphine|The nurse will administer 0,1 mg per kg during 5 seconds when the patient complain of pain (visual analog scale, VAS, ≥7). Immediately with the onset of drug administration a timer started; every 5 minutes the researcher assess the EVA and the drug will be administered if VAS > 3, until the patient manifests as a lower pain VAS ≤ 3 (mild). The nurse in charge in the PACU will manage the drug and will take 10 mg of morphine which is diluted in 10 mL of normal saline leaving a 1 mg per ml concentration, are not labeled and for the physical and chemical characteristics of both drugs (colorless) risks of unblinded is minimized.
16102281|NCT02145962|Device|Forearm tissue exposure with ELF-MF|The treatment was delivered 2 hours/day, 2 times/week and consisted of sinusoidal oscillating magnetic fields of 120 Hz using a solenoid, with nominal field amplitude of approximately 0.6-0.8 mT (6-8 Gauss) RMS at the center of the stimulation system. The amount of blood exposed to the therapeutic ELF-MF using the forearm device is approximately 30 ml/min or 3.6 lt/session.
16102282|NCT02145962|Device|Thorax tissue exposure with ELF-MF|The treatment was delivered 25 minutes/day, 2 times/week and consisted of 120 Hz using a quasi-Helmholtz coil configuration, with nominal field amplitude of approximately 0.6-0.8 mT (6-8 Gauss) RMS at the center of the stimulation system. The amount of blood exposed to the therapeutic ELF-MF using the thorax device should be approximately 6,500 ml/min or 162.5 lt/session, which is approximately 45 times more blood volume stimulation per unit of time compared with the Forearm exposure system.
16102283|NCT02145949|Drug|Essential Amino Acids (EAA)|Twice daily ingestion of 20 or 23 grams of EAA for 7 days leading up to surgery and continuing for 6 weeks after surgery [surgery = primary total knee arthroplasty]
16102284|NCT02145949|Drug|Placebo (Alanine)|Twice daily ingestion of 20 or 23 grams Placebo (alanine) for 7 days leading up to surgery and continuing for 6 weeks after surgery [surgery = primary total knee arthroplasty]
16102285|NCT02145936|Other|diet|Participants are fed diets enriched in oleic acid, palmitic acid or stearic acid.
16102286|NCT02145923|Procedure|Peripheral blood stem cell mobilisation and collection|
16102287|NCT02145923|Drug|High-dose chemotherapy|High-dose chemotherapy will be performed according to protocols ICE and BEAM (standard scheme)
16102288|NCT02145923|Drug|Bone marrow derived allogeneic MMSCs infusion|
16102289|NCT02145923|Procedure|Autologous peripheral blood stem cells infusion|
16102290|NCT02145910|Drug|Vemurafenib|Given PO
16102291|NCT02145910|Radiation|Whole-brain radiation therapy (WBRT)|Undergo WBRT
16102293|NCT02145897|Biological|Autologous Stromal Vascular Fraction (SVF)|Study arm A subjects will receive single dose of autologous adipose derived Stromal Vascular Fraction (SVF) SVF divided in two fraction and infused intravenously and intramuscularly
16102294|NCT02145897|Biological|Autologous Adipose Derieved MSCs|Study arm B subjects will receive one dose of 1 million per kg body weight adipose tissue derived Ex-vivo expanded Mesenchymal stem cells (MSC) intravenously and one dose of 1 million per kg body weight adipose tissue derived Ex-vivo expanded Mesenchymal stem cells (MSC) intramuscularly
16102295|NCT02145897|Other|Control|
16102296|NCT02145884|Drug|timolol maleate 0.5% gel|Apply timolol gel 1-2 drops twice a day to lesion
16102297|NCT02145871|Other|standard fluid management|
16102298|NCT02145871|Other|fluid management guided by the EV1000|
16102299|NCT02145858|Device|Blood drainage post cardiac surgery using PleuraFlow System|
16102300|NCT02145845|Device|Injectable SIS|Injectable SIS
16102301|NCT02145832|Drug|Fluconazole|
16102302|NCT02145832|Drug|Micafungin|
16102303|NCT02145819|Drug|hCG|
16102304|NCT02145819|Other|LH peak|
16102305|NCT02145793|Behavioral|ADHD Group Curriculum|Study specific ADHD Group curriculum was designed and implemented for the study. Parent curriculum included the following topics: What is ADHD, medications, educational advocacy, how to prevent behavioral issues and how to defuse common behavioral challenges and manage stress. Child curriculum included the following topics: what is ADHD, social skills and friendships, handling school and organization skills, understanding feelings and managing negative emotions
16102306|NCT02145780|Dietary Supplement|2g of grape polyphenol extract|Men will have to consume daily 2g of grape polyphenol extract during the 31 days of overfeeding.
16102307|NCT02145780|Dietary Supplement|Dietary Supplement: 2g of placebo (lactose)|Men will have to consume daily 2g of placebo during the 31 days of overfeeding.
16102308|NCT02145767|Drug|Progesterone|
16102309|NCT02145767|Drug|Placebo|
16102310|NCT02145754|Other|MKP media|one half of skin specimen was put in MKP media
16102311|NCT02145754|Other|BSK-H media|one half of skin specimen was put in BSK-H media
16102312|NCT02145741|Drug|Xentuzumab, low dose, every week (qw)|Patient to receive low dose of Xentuzumab IV
16102313|NCT02145741|Drug|Xentuzumab, middle dose, qw|Patient to receive middle dose of Xentuzumab IV
16102314|NCT02145741|Drug|Xentuzumab, high dose, qw|Patient to receive high dose of Xentuzumab IV
16102315|NCT02145728|Behavioral|Individual Cognitive Functional Therapy|Cognitive functional therapy (CFT) is a novel, patient centred behavioural intervention which addresses multiple dimensions in non-specific chronic low back pain (NSCLBP). It combines a functional behavioural approach of normalising provocative postures and movements while discouraging pain behaviours, with cognitive restructuring of the NSCLBP problem.
16102316|NCT02145728|Behavioral|Group Exercise Classes|Each class involves a combination of education, exercise and relaxation/mindfulness. The education topics include pain and the nervous system, posture and ergonomics, exercise and relaxation and sleep. The exercise component includes 10 stations of a combination of aerobic, strength and flexibility exercises. These will be walking/jogging on the spot, mini-squats, sit to stands, wall push ups, bridging, step-ups and a combination of leg and low back stretches. The relaxation/mindfulness component will take place at the end of each class and will involve breathing and relaxation of the body.
16102317|NCT02145715|Drug|Velcade|
16102318|NCT02145715|Drug|Thalidomide|
16102319|NCT02145715|Drug|Dexamethasone|
16102320|NCT02145715|Drug|Panobinostat|
16102321|NCT02145702|Other|Aerobic Exercise|Each exercise session will be conducted at the KUMC Exercise and Cardiovascular Health (REACH) Laboratory. Exercise sessions will include a warm-up period, exercise period and a cool down period. Exercise intervention individualized based on health of participant. Subject will be asked to completed two exercise sessions per week for 12 weeks.
16102322|NCT02145702|Procedure|Standard Care Dialysis|12 weeks of standard of care.
16102323|NCT02145689|Biological|onabotulinumtoxinA|Up to 4 treatments of onabotulinumtoxinA injected into muscles of the study limb on fulfillment of the retreatment criteria.
16102324|NCT02145676|Biological|onabotulinumtoxinA|OnabotulinumtoxinA injected into predefined muscles of the study limb on Day 1.
16102325|NCT02145676|Drug|placebo (normal saline)|Placebo (normal saline) injected into predefined muscles of the study limb on Day 1.
16102326|NCT02145650|Other|No Intervention|There is no intervention administered in this study.
16102327|NCT02145637|Drug|Afatinib plus Ruxolitinib combination therapy|
16102328|NCT02145624|Drug|Repevax|vaccine
16102329|NCT02145624|Drug|Boostrix-IPV|vaccine
16102330|NCT02145611|Drug|Glibenclamide|Glibenclamide
16102331|NCT02145611|Drug|Vildagliptin|Vildagliptin
16102332|NCT02145598|Drug|Lenalidomide|after 6 cycles VMP Patients will receive Lenalidomide given as two capsules 5 mg capsules p.o. daily until progressive disease (PD)
16102333|NCT02145598|Drug|Placebo|after 6 cycles VMP Patients will receive Placebo given as two capsules 5 mg capsules p.o. daily until progressive disease (PD)
16102334|NCT02145585|Device|Test of pharmacologic anesthesia robot (labVIEW® software)|
16102335|NCT02145559|Drug|Metformin XR|
16102336|NCT02145559|Drug|Delayed Metformin|
16102337|NCT02145559|Drug|Sirolimus|
16102338|NCT02145546|Drug|Amiodarone|Amiodarone: 200mg three times a day for two weeks, then change to 200mg per day for the rest of the study.
16102339|NCT02145546|Drug|Propafenone|150mg per 8 hours, 3 times per day
16102340|NCT02145546|Drug|Sotalol|80mg twice per day.
16102341|NCT02145520|Drug|Magnesium Sulfate|The use of magnesium sulfate intravenous in patient with bronchiolitis in pediatric emergency; follow Broncholitis severity score and length of stay
16102342|NCT02145520|Other|placebo|use of placebo with standard therapy
16102343|NCT02145507|Drug|SOLX|SOLX is regulated as a drug but is not intended to provide a direct therapeutic benefit.
16102344|NCT02145494|Radiation|Radiotherapy|Stereotactic body radiotherapy (SBRT) to the whole prostate (36.25 Gy in 5 fractions) with a focal boost (47.5 Gy in 5 fractions) to the MRI-defined dominant tumour nodule.
16102345|NCT02145481|Behavioral|Decision Aid|Decision aid describing treatment choices for patients with coronary artery disease.
16102384|NCT02145182|Drug|Placebo|0.9% sodium chloride
16102346|NCT02145481|Behavioral|CAD Education|Education for patients with coronary artery disease
16102347|NCT02145468|Drug|Losmapimod 7.5 mg twice daily|Subjects will receive Losmapimod 7.5 mg as film-coated, round, plain faced tablets.
16102348|NCT02145468|Drug|Placebo twice daily|Subjects will receive placebo as film-coated, round, plain faced tablets.
16102349|NCT02145468|Drug|Standard therapy|Subjects will receive standard therapy consistent with the appropriate guidelines from professional societies. The standard therapy includes nitrates, morphine sulfate, beta adrenergic blockers, renin-angiotensin aldosterone inhibitors, other anti-ischemic therapies, and analgesic therapy.
16102350|NCT02145455|Device|Unity Total Knee Replacement System|
16102351|NCT02145455|Device|Unity Total Knee Replacement System|
16102352|NCT02145442|Dietary Supplement|Obex|Obex® will be administered two sachets daily dissolved in a glass of water, 30 minutes before lunch and dinner during three months. Participants will be not trained about changes of lifestyle on their diets, or physical activity.
16102353|NCT02145429|Behavioral|Problem Solving therapy and Brief Behavioral Treatment of Insomnia|"Problem Solving therapy teaches problem solving skills that participants can use in their everyday life. A problem is identified, various solutions identified and explored with the underlying focus to learn behavioral and self management strategies.Social casework and management of chronic disease is also included as per the participant's need.
~Brief Behavioral Treatment of Insomnia focuses on improving sleep by promoting sleep hygiene such as time spent in bed and decreasing night time stimuli. The therapy has been suitably modified to suit the needs of the participants to be recruited in the Low and Middle income countries keeping in mind the low level of literacy and the local social and health care services."
16102354|NCT02145403|Drug|Carfilzomib|"Carfilzomib will be administered starting at dose level 1 (20 mg/m2 IV) on day +1, +2, +6 and +7.
~Dose escalation will be performed on the day +6 and day +7 doses only in each dose level. Day +1 and day+2 doses will be fixed at 20 mg/m2 IV in all dose levels."
16102355|NCT02145403|Drug|Tacrolimus|Tacrolimus will be administered at 0.03 mg/kg continuous infusion over 24 hours, starting on day -3 as standard graft-versus-host disease prophylaxis.
16102356|NCT02145390|Procedure|Transurethral Resection of the Bladder Tumor & Cystoscopy|"TURBT and Cystoscopy will be performed by the participating urologist prior to start of neoadjuvant chemotherapy, per the study protocol:
~Cystoscopic evaluation
~Bimanual examination under anesthesia,
~Transurethral resection of the bladder tumor,
~Biopsy of the prostatic urethra including both mucosa and stroma using a resection loop."
16102357|NCT02145390|Radiation|Intensity Modulated Radiation Therapy|"For subjects with complete response to neoadjuvant chemotherapy. Subjects will receive 25 daily fractions (5 weeks) of radiation therapy for 5 days a week (Monday to Friday) except on weekends or holidays, when remaining fractions will be added to the end of treatment. The overall schema is for IMRT based radiation to the entire bladder, prostate (in men) and the pelvic lymph nodes:
~Pelvic lymph nodes: 45 Gy in 25 fractions at 1.8 Gy per fraction.
~Whole bladder and prostate: 50 Gy in 25 fractions at 2.0 Gy per fraction.
~Tumor boost area: 60-65 Gy in 25 fractions at 2.4-2.6 Gy per day
~Final boost dose will be determined at the discretion of the treating physician based on normal tissue exposure and volume."
16102358|NCT02145390|Behavioral|Expanded Prostate Cancer Index Composite Short Form 12|Quality of life questionnaire to be administered to subjects at intervals defined by the study protocol.
16102359|NCT02145390|Behavioral|International Prostate Symptom Score|Quality of life questionnaire to be administered to subjects at intervals defined by the study protocol.
16102360|NCT02145377|Biological|PXVX0200 10E8|Oral dose of PXVX0200 10E8
16102361|NCT02145377|Biological|PXVX0200 10E9|Oral dose of PXVX0200 10E9
16102362|NCT02145377|Biological|Placebo|Oral dose of sodium bicarbonate buffer
16102363|NCT02145377|Biological|Shanchol|Licensed comparator
16102364|NCT02145364|Device|Ultherapy® treatment|Microfocused ultrasound treatment
16102365|NCT02145351|Device|Rate adaptive atrial pacing using a dual-chamber pacemaker|The Azure XT DR is a permanent, dual-chamber cardiac pacemaker with the ability to continuously monitor and record patient activity, and respond to activity by pacing faster and increasing the heart rate (rate adaptive atrial pacing). It will be programmed in AAIR mode to pace the right atrium. The leads will be placed in the right atrium and right ventricle using CapSureFix model 5086.
16102366|NCT02145351|Device|Pacemaker system will be implanted but set to Pacing Off.|The identical pacing system will be implanted, but will be set to Pacing Off.
16102367|NCT02145338|Drug|Nitrofurantoin or Trimethoprim or Cefalexin|Antibiotic prophylaxis
16102368|NCT02145338|Other|No prophylaxis|Discrete treatment courses of antibiotics as indicated by symptoms or signs of UTI.
16102369|NCT02145325|Drug|Expanded Tregs|
16102370|NCT02145312|Drug|BYL719|BYL719 is an oral class I α-specific PI3K inhibitor belonging to the 2-aminothiazole class of compounds.
16102371|NCT02145299|Device|TruePath CTO Device|"The TruePath CTO Device is composed of a 0.018 guidewire and a motor housing with a connector cable along with a sterile, disposable battery-powered Control Unit for manipulation of the device during operation. The TruePath CTO Device is indicated to facilitate the intra-luminal placement of conventional guidewires beyond peripheral artery chronic total occlusions."
16102372|NCT02145299|Device|CROSSER CTO Device|
16102373|NCT02145286|Radiation|Stereotactic Body Radiation Therapy|SBRT is a high dose and highly conformal radiation dose treatment with the goal of rapid tumor killing and/or ablation of tumors
16102374|NCT02145273|Behavioral|Interpersonal Psychotherapy for Depression -Group|
16102375|NCT02145260|Drug|Lower dialysate sodium (138 mmol/L; using Renasol hemodialysis concentrate)|A lower dialysate sodium will bes used in the active comparator arm (138 mmol/L)
16102376|NCT02145260|Drug|Higher dialysate sodium (142 mmol/L; using Renasol hemodialysis concentrate)|A higher dialysate sodium will be used in the experimental arm (142 mmol/L)
16102377|NCT02145247|Drug|hCG|"3. On study day one, recombinant-hCG (r-hCG) will be administered intravenously at a dose of 25 micrograms.
~4. Blood samples will be obtained at T = -0.5, 0, and +24 hours."
16102378|NCT02145234|Drug|BMS-986089|
16102379|NCT02145234|Drug|Placebo matching with BMS-986089|
16102380|NCT02145221|Other|Music Therapy|
16102381|NCT02145208|Device|TIND System|An implant
16102382|NCT02145195|Dietary Supplement|Vitamin D3 (cholecalciferol)|
16102383|NCT02145182|Drug|Eculizumab|Eculizumab is a complement component 5 inhibitor.
16102385|NCT02145169|Drug|Inhaled Nitrous Oxide|Patients undergoing procedural sedation with Ketamine will receive inhaled Nitrous Oxide
16102386|NCT02145156|Behavioral|Tailored educational materials|The tailored intervention will use participants' baseline survey responses to generate tailored educational messages about the HPV vaccine. These educational messages will reflect the top concerns indicated by the participant about the HPV vaccine. Additional tailoring will occur in the form of images matched to self-reported race and age, and using participants' first name in the information presented.
16102387|NCT02145156|Behavioral|Untailored educational materials|"The untailored intervention will present educational information on the iPad that is not responsive to participants' baseline questionnaire answers and instead is derived directly from the HPV Vaccine Information Sheet that has been created by the Centers for Disease Control and Prevention."
16102388|NCT02145156|Behavioral|Survey-only|Those in the usual care arm will be provided with a paper version of the Post Intervention Survey. This will be provided to participants after their clinic visit is completed.
16102389|NCT02145143|Drug|Vemurafenib|
16102390|NCT02145143|Device|serial 124I PET/CT|
16102391|NCT02145143|Drug|thyrotropin alpha|
16102392|NCT02145130|Biological|denovoDerm|Transplantation of an autologous tissue-engineered dermal substitute, covered with autologous split-thickness skin
16102393|NCT02145130|Biological|denovoSkin|Transplantation of autologous tissue-engineered dermo-epidermal skin substitute, no additional coverage needed
16102394|NCT02145117|Behavioral|MBSR|Behavioral
16102395|NCT02145104|Drug|valsartan 160mg, cilnidipine 10mg, cilinidipine 5mg|
16102396|NCT02145091|Drug|Moderately-high dose of psilocybin|Oral dose of a moderately-high dose of psilocybin.
16102397|NCT02145091|Drug|Moderately-low dose of psilocybin|Oral dose of a moderately-low dose of psilocybin.
16102398|NCT02145091|Drug|Very-low dose of psilocybin|Oral dose of a very-low dose of psilocybin.
16102399|NCT02145091|Drug|Placebo|An oral placebo (lactose pill).
16102400|NCT02145078|Drug|docetaxel|Given IV
16102401|NCT02145078|Drug|pemetrexed disodium|Given IV
16102402|NCT02145078|Drug|gemcitabine hydrochloride|Given IV
16102403|NCT02145078|Other|laboratory biomarker analysis|Correlative studies
16102404|NCT02145065|Drug|Local drug delivery via microcrystalline paclitaxel balloon coating (PAK,Balton, Poland)|
16102405|NCT02145065|Device|Plain balloon angioplasty, uncoated balloon (Neptun, Balton, Poland)|
16102406|NCT02145052|Other|Continuous suture|A continuous suture is considered standard of care.
16102407|NCT02145052|Other|Interrupted suture|Interrupted sutures are considered standard of care.
16102408|NCT02145039|Drug|Fludarabine|Fludarabine 30 mg/m2 IV over 30-60 minutes on days -6 through -2 before transplant.
16102409|NCT02145039|Drug|Cyclophosphamide|Cyclophosphamide 14.5 mg/kg IV over 1-2 hours on days -6 and -5 before transplant and Cyclophosphamide 50 mg/kg IV on days 3 and 4 post-transplant.
16102410|NCT02145039|Radiation|Total Body Irradiation|TBI 200cGy on day -1 before transplant.
16102411|NCT02145039|Biological|Haploidentical stem cell transplant|Non-T-cell depleted bone marrow infusion
16102412|NCT02145026|Drug|Epoetin beta|Epoetin beta 30,000 or 60,000 IU per week SC injection
16102413|NCT02145013|Procedure|Liver resection|Hepatectomy by either open, laparoscopic or robotic procedures
16102414|NCT02145000|Biological|Rotavirus vaccine (BRV-PV)|Three doses of BRV-PV containing ≥ Log10 5.6 FFU/Dose of each serotype G1, G2, G3, G4 and G9, or placebo, will be administered at 4 week intervals between doses (with a window of -1 to +4 weeks). The first administration will occur at 6-8 weeks of age.
16102415|NCT02145000|Biological|Placebo|
16102416|NCT02144987|Biological|Bone Marrow CD133+ Stem Cell Transplantation|"Bone Marrow Stem Cell (BMSC) mobilization peripheral blood induced by granulocyte-CSF (G-CSF) 5 mcg/kg sc every 12 hours for 4 days.
~BMSC recollection with apheresis procedure and positive selection of the CD133+ cells.
~The selection procedure will be performed for a maximum of 3 hours or until at least 50 million cells are collected.
~CD133+ cells transplantation into the uterine spiral arterioles by intra-arterial catheterization
~Subsequently Hormonal Replacement Therapy (HRT) will be given to the patients
~Hysteroscopy will be performed 2-3 months after stem cell transplantation
~Embryo transfer will be performed 3-6 months after stem cell transplantation with HRT endometrial preparation"
16102417|NCT02144948|Drug|e.-coli-nissle|1 ml qd for 24 weeks
16102418|NCT02144922|Drug|Pitavastatin|statin
16102419|NCT02144922|Other|Control|Life style modification alone
16102420|NCT02144909|Behavioral|Partners in Care with Semi-Structured Support Group|
16102421|NCT02144896|Other|Ankle splinting|Ankle dorsiflexion splinting will be performed 30 minutes per day, 5 days per week for 4 weeks.
16102422|NCT02144883|Behavioral|Telephone counseling|Subjects randomized into the telephone counseling condition received one comprehensive pre-quit call lasting about 45 minutes; five follow-up calls during the pregnancy, scheduled according to the risk of relapse after the quit attempt (1, 3, 7, 14, and 30 days after the quit date) one 30-minute pre-birth call scheduled after 36 weeks gestation and two additional follow-up sessions scheduled for 14 and 28 days after the baby's birth. The counseling used a proactive calling procedure in that counselors made all the calls based on agreed-upon dates with the clients. This proactive approach aimed to foster a positive counseling relationship, provide accountability, and create opportunities to address wavering motivation, reduce attrition, and minimize relapse.
16102423|NCT02144883|Behavioral|Self-help materials|All subjects received a self-help quit kit for pregnant smokers and fact sheets on second-hand smoke and additional tips for quitting while pregnant. Subjects in the counseling intervention group received five additional mailings. These mailings were designed to remind them of their commitment to quitting and of the presence of counseling support if they needed help. Mailings included a pamphlet on pregnancy facts, a refrigerator magnet with the quitline number, and a social support planning worksheet that were sent at 4.5 months, 6 months, and 7.5 months gestation, respectively. They also received a congratulatory card soon after the birth and a brochure with tips for parenting newborns that was sent at one month postpartum.
16102424|NCT02144870|Behavioral|Habit Reversal Training|awareness training, competing response training
16102425|NCT02144870|Behavioral|Resources activation|
16102426|NCT02144857|Drug|etanercept|50 mg
16102427|NCT02144857|Drug|ustekinumab|45 mg
16102428|NCT02144857|Drug|cyclosporine|Cyclosporine 2.5-3 mg/kgr
16102431|NCT02144844|Behavioral|Insight-Plus Cognitive Behavioral Intervention|Insight-Plus is a 6-session, manualized, cognitive behavioral intervention (CBI) culturally tailored for a diverse group of rural low-income women at low and high risk for antepartum depression.
16102432|NCT02144831|Drug|anti-thrombotic treatment using Aspirin (ASA 75-325mg) and Clopidogrel (75mg)|comparisson of what is the efficacy and safety of 10 days to 30 day treatment of aspirin (ASA)+Clopidogrel
16102433|NCT02144818|Drug|Ovitrel|Triggering of ovulation with Ovitrel
16102434|NCT02144818|Drug|Decapeptyl|Triggering with GnRH agonist
16102435|NCT02144805|Procedure|Suturing in a single layer|The procedure define the use of one single suture for closure of the uterine incision following cesarean section.
16102436|NCT02144805|Procedure|Suturing in two layer|The procedure define the use of two sutures for closing the uterine incision following cesarean section
16102437|NCT02144792|Drug|[11C] -verapamil PET|While P-gp inhibitor (Cyclosporin A, 2.5mg/kg/hr during 2hours, intravenous) is infused, PET scans were done using [11C] -verapamil, a substrate of P-gp.
16102438|NCT02144779|Behavioral|Assigned to palliative care team|Communication and Support through the palliative care team assigned to intervention participants.
16102439|NCT02144779|Behavioral|Usual Care|usual hospital care, not assigned to palliative care team
16102440|NCT02144766|Drug|ropivacaine|caudal block with 1 ml/kg of ropivacaine 0.2%
16102441|NCT02144766|Drug|saline|caudal block with 1 ml/kg of saline
16102442|NCT02144753|Dietary Supplement|NTX-1|Investigational NTX-1 fiber to be taken as three (6g each) packets of the fiber per day, one 8g packet in the morning (one hour before eating breakfast) and the other two 8g packets in the afternoon and evening.Fasting required for the morning dose and recommended with afternoon and evening dose.
16102443|NCT02144753|Drug|psyllium (15 g)|Psyllium (an over-the-counter fiber) to be taken as three (5g each) packets of the fiber per day, one 5g packet in the morning (one hour before eating breakfast) and the other two 5g packets in the afternoon and evening.Fasting required for the morning dose and recommended with afternoon and evening dose.
16102444|NCT02144740|Dietary Supplement|NWT-03, an egg-white protein hydrolysate|For placebo comparator, a combination of sweetener + aroma, which was equal to the combination used in the intervention period, was given
16102445|NCT02144740|Dietary Supplement|Placebo|A combination of sweetener + aroma , which was equal to the combination used in the intervention period, was given.
16102446|NCT02144727|Procedure|D2 distal subtotal gastrectomy|D2 includes Nos.1.3,4sb,4d,5,6,7,8a,9,11p,and 12a nodes in Japanese classification. Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy.
16102447|NCT02144727|Procedure|D1+ distal subtotal gastrectomy|D1+ includes Nos.1,3,4sb,4d,5,6,7,8a,and 9 nodes in Japanese classification. Systemic en bloc lymph node dissection is mandatory. Resection margin should be negative for malignancy with intraoperative frozen biopsy
16102448|NCT02144714|Biological|SB5|
16102449|NCT02144714|Biological|EU sourced Humira®|
16102450|NCT02144714|Biological|US sourced Humira®|
16102451|NCT02144701|Dietary Supplement|Lactobacillus rhamnosus GG|Given PO
16102452|NCT02144701|Other|laboratory biomarker analysis was not performed because of no differences in the clinical outcomes|Correlative studies
16102453|NCT02144688|Drug|Change in antiretrovirals|Change in ARVs to improve cognition: Personalized change in antiretrovirals will be based on CSF analysis
16102454|NCT02144675|Drug|choline magnesium trisalicylate|Given PO
16102455|NCT02144675|Drug|idarubicin|Given IV
16102456|NCT02144675|Drug|cytarabine|Given IV
16102457|NCT02144675|Other|laboratory biomarker analysis|Correlative studies
16102458|NCT02144662|Drug|Ranibizumab|0.5mg ranibizumab intravitreal injection
16102459|NCT02144649|Dietary Supplement|dietary intervention (tangerine tomato juice)|Group II will consume two 5.5 oz. cans of tangerine tomato juice every day until their scheduled surgery. (approximately 4 weeks).
16102460|NCT02144649|Dietary Supplement|dietary intervention (red tomato juice)|Group III will consume two 5.5 oz. cans of red tomato juice every day until their scheduled surgery (approximately 4 weeks).red tomato juice
16102461|NCT02144649|Other|questionnaire administration|Men enrolled in the study will be asked to complete a 3-Day Food Record and a series of additional questionnaires (urologic symptom and quality of life questionnaire) at home.
16102462|NCT02144649|Other|Correlative studies|Blood and urine samples at enrollment and blood, urine, and prostate tissue at the time of surgery to determine compliance with the intervention product and tomato phytochemical biodistribution. Additionally, we will correlate each type of tomato juice with lycopene presence in plasma, urine, and tissue provided by subjects on the day of surgery.
16102463|NCT02144636|Dietary Supplement|herbalife protein shake|
16102464|NCT02144623|Drug|Valproate|
16102465|NCT02144610|Biological|HGF Plasmid (AMG0001)|IM
16102466|NCT02144610|Biological|Matching Placebo|IM
16102467|NCT02144597|Dietary Supplement|Liquid formula low-calorie diet (LCD)|The liquid formula low-calorie diet (LCD) will provide 800kcal/day from powdered milkshakes and soups. The diet will be provided by Cambridge Weight Plan.
16102468|NCT02144597|Procedure|Roux-en-Y gastric bypass (RYGB)|Participant went through Roux-en-Y gastric bypass (RYGB) surgery
16102469|NCT02144597|Other|Control diet|
16102470|NCT02144584|Drug|Memantine XR|The active drug will be encapsulated by the University of Utah Research Pharmacy to maintain blinding.
16102471|NCT02144584|Drug|Placebo (for memantine)|Placebo to be capsuled to look identical to active drug (memantine)
16102472|NCT02144571|Behavioral|Lifestyle|Participants are consented and randomized into the intervention group or delayed intervention group(intervention offered one year later). Participants in intervention group attend 12 weekly sessions and 9 monthly sessions. All participants attend 3 clinics in which we collect data, measurements and blood samples. These clinics occur at baseline, 12 weeks and one year.
16102473|NCT02144558|Other|penile vibratory stimulation (PVS) or masturbation|penile vibratory stimulation (PVS) or masturbation
16102474|NCT02144545|Procedure|Bougie Size 33 Fr|Comparison of the bougie size and distance from the pylorus for the sleeve gastrectomy
16102475|NCT02144545|Procedure|Bougie Size 42 Fr|Comparison of the bougie size and distance from the pylorus for the sleeve gastrectomy
16103069|NCT02140021|Other|Laboratory Biomarker Analysis|Correlative studies
16102476|NCT02144545|Procedure|Distance pylorus 2 cm|Comparison of the bougie size and distance from the pylorus for the sleeve gastrectomy
16102477|NCT02144545|Procedure|Distance pylorus 5 cm|Comparison of the bougie size and distance from the pylorus for the sleeve gastrectomy
16102478|NCT02144532|Device|short-sleeved vest CICATREX SED®)|Each patient wears a compression custom-made garment (short-sleeved vest CICATREX SED®) according to the medical prescription during the first 4 weeks (BEFORE phase). Then each patient should not wear the compression garment for the next 4 weeks (AFTER phase).
16102479|NCT02144519|Behavioral|Healthy Eating and Physical Activity|Create partnerships with ASPs to help facilitate changes in programming to meet the National Afterschool Alliance's HEPA Standards.
16102480|NCT02144506|Other|T&E|
16102481|NCT02144506|Other|OTAGO|
16102482|NCT02144493|Other|The existence of periampullary diverticulum|Periampullary diverticulum has been postulated as risk factor of recurrent CBD stone.
16102483|NCT02144493|Other|CBD angle|Narrow CBD angle has been postulated as risk factor for the development of recurrent CBD stone
16102484|NCT02144480|Behavioral|Intensive training|The IT group will receive physiotherapy twice daily with longer duration and higher intensity
16102485|NCT02144480|Behavioral|traditional training|usual care: conventional rehabilitation
16102486|NCT02144467|Device|MRI|fMRI, sMRI, ASL and DTI
16102487|NCT02144454|Dietary Supplement|Saturated fat|
16102488|NCT02144454|Dietary Supplement|Monounsaturated fat|
16102489|NCT02144454|Dietary Supplement|n-6 polyunsaturated fat|
16102490|NCT02144441|Drug|glargine and aspart|Inpatient will administer hospital-dispensed basal-bolus insulin (glargine and aspart) according to a regimen developed in collaboration with the diabetes consult service.
16102491|NCT02144415|Drug|EB-1020 400 mg|4 x EB-1020 100-mg capsules, and 4 matching placebo capsules
16102492|NCT02144415|Drug|EB-1020 800 mg|8 x EB-1020 100-mg capsules
16102493|NCT02144415|Drug|lisdexamfetamine 150 mg|3 x capsules, each containing 1 lisdexamfetamine 50-mg capsule, and 5 x matching placebo capsules
16102494|NCT02144415|Drug|d-amphetamine 40 mg|4 x capsules, each containing 2 d-amphetamine 5-mg tablets, and 4 x matching placebo capsules
16102495|NCT02144415|Drug|Placebo|8 x matching placebo capsules
16102496|NCT02144402|Other|infant formula with DHASCO|
16102497|NCT02144402|Other|infant formula with DHASCO-B|
16102498|NCT02144389|Drug|Praziquantel (PZQ)|"40 mg/kg, a single dose, administered orally
~1 g of corn/soybean oil (50%/50%), administered orally"
16102499|NCT02144389|Dietary Supplement|Arachidonic acid (ARA)|ARA (40% of total fatty acid)
16102500|NCT02144389|Dietary Supplement|PZQ+ARA|A single dose of PZQ administered seven days in advance of initial treatment with ARA.
16102501|NCT02144376|Dietary Supplement|Ispaghula|
16102502|NCT02144376|Dietary Supplement|Maltodextrin|
16102503|NCT02144350|Procedure|Hyperbaric oxygen|patients will be placed in a monoplane chamber and pressurized to 2.4 atmospheres with 100% oxygen for 90 minutes per session.
16102504|NCT02144350|Procedure|Sham Hyperbaric Air|Patients will undergo a brief compression to 1.34 atmospheres with room air and then they will be brought back to 1.1 atmospheres to complete a 90 minute session.
16102505|NCT02144337|Behavioral|Steps To Active Kids (STAK) programme|Intervention described in Arm/Group Description.
16102506|NCT02144324|Device|Tandem Appliance|We are going to use a modified version of the Tandem Appliance
16102507|NCT02144311|Procedure|PET/CT Scan|
16102508|NCT02144311|Procedure|MRI|
16102509|NCT02144285|Drug|LY3113593|Administered IV
16102510|NCT02144285|Drug|LY3113593|Administered SC
16102511|NCT02144285|Drug|Placebo|Administered IV
16102512|NCT02144285|Drug|Placebo|Administered SC
16102513|NCT02144272|Drug|LY3114062 SC|LY3114062 administered SC.
16102514|NCT02144272|Drug|Placebo|Placebo administered SC.
16102515|NCT02144272|Drug|LY3114062 IV|LY3114062 administered IV.
16102516|NCT02144259|Drug|DMPA immediately postpartum|DMPA is an intramuscular injection of 150mg of depot medroxyprogesterone acetate.
16102517|NCT02144259|Drug|Implanon immediately postpartum|Implanon ® is a subdermal implant that contains 68mg of etonogestrel.
16102518|NCT02144246|Other|Non-hormonal period|
16102519|NCT02144246|Drug|Ortho-cyclen, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg|
16102520|NCT02144233|Procedure|Occlusal adjustment|"The first step consists of the elimination of premature tooth contacts during retruded jaw closure.
~The second step included reduction of the steeper lateral anterior guidance; the magnitude of this alteration will be estimated by the following equation: (right condylar path) × (left anterior guidance) = (left condylar path) × (right anterior guidance)"
16102521|NCT02144233|Procedure|Placebo occlusal adjustment|Placebo occlusal adjustment will take place in a manner identical to the real adjustment. However, a specially fabricated inactive rotary instrument will be used, and no enamel will be removed.
16102522|NCT02144220|Other|Virtual care visit|Video-conferencing visit with a Parkinson disease specialist
16102523|NCT02144207|Device|Glidescope|
16102524|NCT02144194|Drug|Vinorelbine-Docetaxel|Vinorelbine I.V: 20mg/m2 D1 Docetaxel: 60mg/m2 D1 Vinorelbine Oral: 60mg/m2 D8 Every 3 weeks x 6 cycles
16102525|NCT02144194|Drug|Vinorelbine|Oral Vinorelbine 60mg/m2 or 80mg/m2 D1, D8 every 3 weeks until disease progression, unacceptable toxicities or patient refusal to continue (dose schedule is at investigator's discretion)
16102526|NCT02144181|Device|Ulthera System Treatment|Focused ultrasound energy delivered below the surface of the skin
16102527|NCT02144168|Dietary Supplement|Prebiotics-free enteral formula|Patient will be given Osmolite 1 cal for 2 weeks after baseline stool sample obtained
16102528|NCT02144168|Dietary Supplement|Prebiotics containing enteral formula|Patient will be given Ensure Fos for 2 weeks after baseline stool sample obtained
16102529|NCT02144155|Drug|Oxytocin: 24IU - 168 IU|Oxytocin: 24IU - 168 IU
16102530|NCT02144155|Drug|Placebo|placebo drug
16102531|NCT02144142|Biological|Moisturizer with each subject's own antimicrobial bacteria|
16102532|NCT02144129|Other|active Whole Body Electromyostimulation|
16102533|NCT02144129|Other|Passive WB-EMS|
16102534|NCT02144129|Device|WB-EMS application|
16102719|NCT02142751|Drug|Fosfomycin sodium intravenous|4g every 6 hours iv (60 min infusion)
16102535|NCT02144116|Other|Dance-movement therapy|The dance-movement was practised in groups. Dance-movement therapy derived from dance education. The goals of dance-movement therapy included assessing patient needs, communicating emotions, improving self-control, organizing thoughts and actions, developing interpersonal skills, integrating physical and emotional selves, promoting body awareness, and supporting healing.
16102536|NCT02144116|Other|Control group|Standardized educational information in the form of a leaflet about balance disorders and quality of life in fibromyalgia.
16102537|NCT02144103|Other|Subtenon administration of autologous ADRC|
16102538|NCT02144103|Procedure|Liposuction|
16102539|NCT02144103|Device|ADRC isolation|ADRC isolation performed using Celution 800/CRS System (Cytori Therapeutics Inc) according to manufacturer's protocol
16102540|NCT02144090|Device|Fractional flow reserve measurement|Fractional flow reserve measurement
16102541|NCT02144077|Drug|BF-200 ALA|Topical treatment for photodynamic therapy combining drug application and subsequent illumination with a narrow spectrum light source (after 3 h of drug incubation)
16102542|NCT02144077|Drug|methyl-aminolevulinate|Topical treatment for photodynamic therapy combining drug application and subsequent illumination with a narrow spectrum light source (after 3 h of drug incubation)
16102543|NCT02144064|Drug|Heparin|Group A (n = 100) are put on Inj. UFH (Cal-heparin) 5000 U subcutaneous twice daily plusAspirin 81 mg/day (Juspirin) with the ﬁrst positive pregnancy test, Inj. UFH is given either into anterior abdominal wall or anterior aspect of thigh subcutaneously
16102544|NCT02144051|Drug|AZD5312|AZD5312 is a generation 2.5 antisense oligonucleotide (ASO) which is designed with the purpose of specifically suppressing human Androgen Receptor (AR) expression, thereby providing potential therapeutic benefit for the treatment of mCRPC and other AR-dependent cancers.
16102545|NCT02144038|Drug|LGH447|pan-PIM inhibitor
16102546|NCT02144038|Drug|BYL719|PI3K-alpha inhibitor
16102547|NCT02144025|Drug|Cyclosporine|Use of topical cyclosporine (one drop of cyclosporine in each eye, twice a day for 12 months)
16102548|NCT02144012|Drug|Trastuzumab|For the first three-week cycle, trastuzumab was administered IV at 8 mg/kg. For subsequent cycles, trastuzumab was administered IV at 6 mg/kg Q3W.
16102549|NCT02144012|Drug|Trastuzumab Emtansine|Trastuzumab emtansine 3.6 milligrams/kilogram (mg/kg) was administered intravenously (IV) over 30-90 minutes Q3W.
16102550|NCT02144012|Drug|Docetaxel|Docetaxel was administered IV at either 75 milligrams/square meter (mg/m^2) or 100 mg/m^2 Q3W.
16102551|NCT02143973|Drug|nalbuphine HCl ER|nalbuphine HCl ER
16102552|NCT02143960|Device|VelaShape III|Subjects will receive one treatment to their entire waist / love-handle/ flanks area in a split-waist fashion, so that one side is treated with one device and the other side is treated with the other device. The treatment session will include: one side (right or left) treated with the VelaShape III device and the other side (left or right, respectively) with the CoolSculpt device. The subject will be randomized to one of 2 treatment groups, one will receive treatment to the left side with the VelaShape II and the right side will receive treatment with the CoolSculpt. The other group will receive treatment to right side with the VelaShape II and the left side will receive treatment with the CoolSculpt.
16102553|NCT02143960|Device|CoolSculpt|Noninvasive Cryolipolysis
16102554|NCT02143947|Device|Maximal Arch Subtalar Stabilization|Custom made semi-rigid thermoplastic heel cup extending to the base of the metatarsals with a full foot length 3.0mm thick EVA and ultra-suede top cover
16102555|NCT02143947|Device|Full Contact Orthosis|"The Full Contact orthosis is constructed from a 5/32 blue polypropylene with posting material comprised of white polypropylene."
16102556|NCT02143934|Drug|Primaquine|
16102557|NCT02143934|Drug|Placebo|Sugar pills, appearance identical to Primaquine tablets
16102558|NCT02143934|Drug|Chloroquine|
16102559|NCT02143934|Drug|Artemether Lumefantrine|
16102560|NCT02143921|Behavioral|Training intervention|Intervention group service providers received intervention training
16102561|NCT02143908|Dietary Supplement|lysine supplementation|
16102562|NCT02143908|Dietary Supplement|Placebo|
16102563|NCT02143882|Drug|Fluenz|Live attenuated influenza vaccine
16102564|NCT02143869|Device|Bioelectrical Impedance Analysis|Measurements of body composition including fat mass, lean body mass, muscular mass, mineral mass, total body water, intra and extracellular water.
16102565|NCT02143856|Drug|100 mg GLPG1205|A single dose of 100 mg GLPG1205 administered as two capsules of 50 mg
16102566|NCT02143843|Drug|Bimatoprost|Bimatoprost Ocular Insert used continuously for 7 months, then replaced with a new Bimatoprost Ocular Insert and used continuously for another 6 months.
16102567|NCT02143830|Drug|Busulfan|"A standard dose of busulfan, associated with excellent outcomes in our previous trial will be used for young patients with marrow aplasia (arm A).
~A higher dose of busulfan will be used in younger patients with MDS and AML (arm B) to maximize disease control.
~A lower dose of busulfan will be used in older patients (arm C) to minimize toxicity."
16102568|NCT02143830|Drug|Cyclophosphamide|Arms A, B and C - Cytoxan will be given as a 1-2 hour infusion for 4 days. The dose will be adjusted according to patients ideal body weight for obese patients.
16102569|NCT02143830|Drug|Fludarabine|Arms A, B and C - Fludarabine will be given IV over 30 minutes daily for 4 days. The dose will be adjusted according to renal function according to Institutional guidelines.
16102570|NCT02143830|Drug|rabbit ATG|Arms A, B and C - 4 doses will be given prior to transplant to promote engraftment.
16102571|NCT02143830|Drug|G-CSF|All patients will also receive G-CSF post-transplant to foster engraftment.
16102572|NCT02143830|Biological|Peripheral blood stem cell|The source of stem cells for all patients will be peripheral blood stem cells (PBSC) induced and mobilized by treatment of the donor with G-CSF for 4-6 days. T-cell depletion will be uniformly performed by positive CD34 selection with the use of the Miltenyi system (CliniMACS device).
16102573|NCT02143817|Dietary Supplement|L-citrulline supplementation|
16102615|NCT02143466|Drug|Part A - AZD9291 in combination with continuous selumetinib (Asian subjects)|Part A - AZD9291 and selumetinib (continuous treatment) administered in different doses to investigate the safety and tolerability of this combination in Asian subjects and to define the combination dose for further clinical evaluation in Part B.
16102720|NCT02142751|Drug|Meropenem intravenous|1g every 8 hours (15-30 min infusion) It depends on strain sensitivity: Strain with resistance to cephalosporins
16102574|NCT02143817|Other|Whole Body Vibration Training|The Whole body vibration training intervention consists of lower-body exercise in a vibration platform 3 times per wk for 8 wk. The subjects will perform static and dynamic exercises for the legs on the vibration platform. Dynamic exercises will be performed with slow controlled movements starting from an upright position into a 60 degree knee flexion (squat) and maximal heel elevation (toestand). Static exercises will be performed without movement in the joint angles described previously. The training volume will increase progressively over the 12-week training period by increasing the intensity of vibration, duration of the exercise set (30-60 sec), number of sets per exercise, and total duration of the training session, and decreasing the duration of rest periods (30-60 sec).The intensity of vibration and amplitude will also be increased progressively (25-30 Hz of frequency and from low to high amplitude).
16102575|NCT02143804|Biological|oncolytic adenovirus expressing GMCSF|Treatment once weekly by intravesical route. Use of DDM to first remove the GAG layer of the bladder and to improve virus transduction. Installation of 100 ml. of CG0070 at 10e12 viral particles for 45 minutes inside bladder.
16102576|NCT02143791|Procedure|Burst stimulation|
16102577|NCT02143791|Device|Prodigy system|
16102578|NCT02143778|Device|Methacetin Breath Test|13C labelled methacetin solution for breath test monitoring
16102579|NCT02143765|Drug|Mitiglinide|three times a day, orally, for 12 weeks
16102580|NCT02143765|Drug|Acarbose|three times a day, orally, for 12 weeks
16102581|NCT02143752|Behavioral|Mindfulness|Group behavioral intervention using mindfulness to help smokers quit smoking
16102582|NCT02143752|Behavioral|Quit Line|see arm
16102583|NCT02143726|Drug|sorafenib|Given PO
16102584|NCT02143726|Drug|everolimus|Given PO
16102585|NCT02143713|Drug|Elagolix|Elagolix tablets administered orally
16102586|NCT02143700|Other|Cognitive assessment|Patients are going to be assessed regarding the outcome measures
16102587|NCT02143687|Behavioral|Moderate altitude sojourn|Participants will travel from Zurich (490 m) to St. Moritz Salastrains (2048 m) and stay there for 2 days
16102588|NCT02143687|Behavioral|Low altitude sojourn|Low altitude baseline evaluations will be performed during a stay at Zurich (490)
16102589|NCT02143687|Drug|Oxygen|Oxygen administration via a nasal cannula at a rate of 3 L/min during nights spent at 2048 m
16102590|NCT02143687|Drug|Sham oxygen (room air)|Sham oxygen (room air) administration via a nasal cannula at a rate of 3 L/min during nights at 490 m and 2048 m
16102591|NCT02143674|Other|Muscle stretching and Strength Training|"Each step of stretching on specific muscles was repeated three times by keeping the posture for 30 seconds, (Arnold and Kokkonen, 2007; Toraman A, Yildirim. 2010; Dai, Ware, Giuliani, 2012; Duque et al., 2013; Granacher et al., 2013). The Pectoral, Quadriceps, Paraspinal, Abdominal and Ischial tibial and sural triceps muscles were elongated.
~Strength Training Muscle strengthening was performed using weights and dumbbells. The training load individually determined through the test of strength with 10 repetitions maximum. The load was reevaluated four weeks of training. The Abdominal, Paraspinal, Quadriceps and Posterior thigh muscles (hamstrings) were submitted to the intervention protocol."
16102592|NCT02143674|Other|Educated about physical exercises|
16102593|NCT02143648|Drug|nalbuphine HCl ER tablets 60 mg BID|nalbuphine HCl ER tablets 60 mg BID administered for 6 weeks
16102594|NCT02143648|Drug|nalbuphine HCl ER tablets 120mg BID|nalbuphine HCl ER tablets 120mg BID administered for 6 weeks
16102595|NCT02143648|Drug|Placebo tablets BID|Placebo tablets BID administered for 8 weeks
16102596|NCT02143635|Drug|HDM201|
16102597|NCT02143635|Drug|ancillary treatment|
16102598|NCT02143622|Biological|LJM716|antibody
16102599|NCT02143622|Biological|cetuximab|antibody
16102600|NCT02143609|Drug|oxygen|Nocturnal nasal oxygen during stay at 2048 m
16102601|NCT02143609|Drug|sham oxygen (room air)|Sham oxygen (room air) via nasal cannula, 3 L/min, at 2048 m
16102602|NCT02143596|Other|normal saline|the infusion rate of normal saline is determinated by clinicians according to Bun/Cr ratio followed
16102603|NCT02143570|Drug|Darifenacin|Darifenacin will be prescribed in a starting dose of 7.5mg, once daily. This dose may be increased to 15mg a day in cases with refractory symptoms.
16102604|NCT02143570|Procedure|Physiotherapy|All patients will received a tailored pelvic floor exercise programme as part of the standard of care of overactive bladder at the study centre. This intervention will be mainly comprised of biofeedback stimulation techniques.
16102605|NCT02143557|Other|Fat-Modified Breast Milk|
16102606|NCT02143557|Other|MCT formula|
16102607|NCT02143544|Device|Intra-aortic balloon pump.|Preoperative placement of the intra-aortic balloon pump.
16102608|NCT02143531|Drug|4 mg of Ondansetron IV|
16102609|NCT02143531|Drug|1mg of Haloperidol IV|
16102610|NCT02143518|Biological|Na-GST-1/Alhydrogel®|The Na-GST-1 candidate vaccine contains the recombinant Na-GST-1 protein expressed by Pichia pastoris. Purified Na-GST-1 was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10% glucose and 10 mM imidazole. The final concentration of Na-GST-1 in the drug product is 0.1 mg/ml whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-GST-1 will be delivered by injecting different volumes of the 0.1 mg/ml Na-GST-1 preparation.
16102611|NCT02143518|Biological|CpG 10104|Unmethylated cytosine-guanine dinucleotides (CpGs) are found in bacterial DNA in the expected frequency predicted by random usage, whereas their occurrence is suppressed 4-fold in vertebrate DNA. In vertebrate DNA CpG motifs are also usually methylated. Bacterial CpG-DNA motifs are recognized by the human innate immune system via Toll-like Receptor-9 (TLR-9), a pathogen-associated molecular pattern (PAMP) receptor that is expressed, in particular, by antigen-presenting dendritic cells. Interactions between CpG-DNA and TLR9 rapidly activate antigen-presenting dendritic cells to upregulate co-stimulatory molecules and to produce Th1-polarizing cytokines such as interleukin-12 and interferon gamma. CpG 10104 is a short synthetic oligodeoxynucleotide of the following sequence: 5'-TCG TCG TTT CGT CGT TTT GTC GTT-3'.
16102612|NCT02143505|Drug|Ca plus vit D|elemental calcium 1200mg/d plus vitamin D3 250 IU/d daily supplements
16102613|NCT02143479|Drug|Tacrolimus|oral
16102614|NCT02143466|Drug|Part A - AZD9291 in combination with AZD6094|Part A - AZD9291 and AZD6094 administered in different doses to investigate the safety and tolerability of this combination and define the combination dose for further clinical evaluation in Part B.
16102616|NCT02143466|Drug|Part A - AZD9291 in combination with continuous selumetinib (non-Asian subjects)|Part A - AZD9291 and selumetinib (continuous treatment) administered in different doses to investigate the safety and tolerability of this combination in non-Asian subjects and to define the combination dose for further clinical evaluation in Part B.
16102617|NCT02143466|Drug|Part A - AZD9291 in combination with intermittent selumetinib|Part A - AZD9291 and selumetinib (intermittent treatment) administered in different doses to investigate the safety and tolerability of this combination and to define the combination dose for further clinical evaluation in Part B.
16102618|NCT02143466|Drug|Part A - AZD9291 in combination with MEDI4736|"Part A - AZD9291 and MEDI4736 administered in different doses to investigate the safety and tolerability of this combination and to define the combination dose for further clinical evaluation in Part B.
~Note: Enrolment into the patient cohort that evaluated AZD9291 treatment in combination with MEDI4736 as 1st line treatment has been terminated due to an increased incidence of ILD-like events (interstitial lung disease/pneumonitis), and is no longer being evaluated in this study."
16102619|NCT02143466|Drug|Part B - AZD9291 in combination with AZD6094|Part B - AZD9291 and AZD6094 administered in the dose identified in Part A (AZD9291 80mg OD + AZD6094 600mg OD) to further investigate the safety and tolerability of this combination.
16102620|NCT02143466|Drug|Part B - AZD9291 in combination with selumetinib|Part B - AZD9291 and selumetinib administered in the dose identified in Part A (AZD9291 80mg OD + selumetinib 75 mg BD intermittent [4 days on/3 days off]) to further investigate the safety and tolerability of this combination.
16102621|NCT02143466|Drug|Part B - AZD9291 in combination with MEDI4736|"Part B - AZD9291 and MEDI4736 administered in the dose identified in Part A to further investigate the safety and tolerability of this combination.
~Note: Enrolment into the patient cohort that evaluated AZD9291 treatment in combination with MEDI4736 as 1st line treatment has been terminated due to an increased incidence of ILD-like events (interstitial lung disease/pneumonitis), and is no longer being evaluated in this study."
16102622|NCT02143466|Drug|Part C - AZD6094 monotherapy (Japan only)|Part C - AZD6094 monotherapy to assess the safety, tolerability and pharmacokinetics of the monotherapy of AZD6094 in Japanese patients with advanced NSCLC.
16102623|NCT02143466|Drug|Part C - AZD9291 in combination with AZD6094 (Japan only)|Part C combination cohort - AZD9291 80mg OD administered in combination with AZD6094 400mg OD (AZD6094 dose in which DLTs have not been identified in the Japanese monotherapy cohort) in order to confirm the safety, tolerability, pharmacokinetics and preliminary anti-tumor activities of this combination in Japanese subjects. The 400mg OD dosing schedule will be initiated in the first cohort. The dose may be subsequently reduced in further cohorts in response to emerging safety, or PK findings or other reasons identified in the savolitinib programme.
16102624|NCT02143466|Drug|Part D - AZD9291 in combination with AZD6094|Part D - AZD9291 80mg OD administered in combination with AZD6094 300mg OD to further evaluate the safety, tolerability, pharmacokinetics and antitumor activity in terms of ORR and PFS in patients with locally advanced or metastatic cMET positive EGFRm+ and T790M-negative NSCLC, following progression on EGFR-TKI treatment. The choice of AZD6094 dose of 300 mg is based on results from preclinical and clinical studies. Clinical testing of the 300 mg OD dose will enable better assessment of impact of lower AZD6094 exposure on overall tolerability and hepatotoxicity risk as well as exploration of the efficacy and overall safety profiles with a dose meaningfully lower than the current dose of 600 mg OD.
16102625|NCT02143453|Other|Endurance training|30 to 60-minute continuous exercise at 80% of the peak heart rate
16102626|NCT02143453|Other|High intensity interval training|3 to 6 sets of 60-second sprints at 100% of the peak velocity interspersed by a 3-min active recovery period.
16102627|NCT02143440|Behavioral|The initial assessment of daily insulin dose.|
16102628|NCT02143427|Behavioral|Social Skills Training|"Behavioral: computer-based Treatment Program for Children with Aggressive Behavior 16 sessions with the child aiming at the reduction of peer related aggressive behavior via social skills training. Additionally up to 2 sessions with relatives of the child in most cases with the parents and subsequent Treatment Program for Children with Aggressive Behavior 16 sessions with the child aiming at the reduction of peer related aggressive behavior via social skills training. Additionally up to 6 sessions with relatives of the child in most cases with the parents.
~Arms: Social Skills Training"
16102629|NCT02143427|Behavioral|Treatment Program with techniques to activate resources|"Behavioral: Treatment Program with techniques to activate resources 16 sessions with the child aiming at the reduction of peer related aggressive behavior via activate resources. Additionally up to 2 sessions with relatives of the child in most cases with the parents and subsequent computer based Treatment Program for Children with Aggressive Behavior 16 sessions with the child aiming at the reduction of peer related aggressive behavior via social skills training.
~Arms: Treatment Program with techniques to activate resources of the child and subsequent Social Skills Training"
16102639|NCT02143401|Other|Laboratory Biomarker Analysis|Correlative studies
16102640|NCT02143401|Biological|Navitoclax|Given PO
16102641|NCT02143401|Other|Pharmacological Study|Correlative studies
16102642|NCT02143401|Drug|Sorafenib|Given PO
16102643|NCT02143401|Drug|Sorafenib Tosylate|Given PO
16102644|NCT02143388|Drug|IMRT combine with cisplatin concurrent chemotherapy|Patients in the control arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during RT.
16102645|NCT02143388|Drug|IMRT combine with cisplatin concurrent chemotherapy plus capecitabine adjuvant chemotherapy|Patients in the experimental arm received radical radiotherapy with IMRT, and cisplatin (100mg/m2 on day 1) every three weeks for three cycles during RT,followed by adjuvant chemotherapy with oral capecitabine(1000mg/m2/ twice a day for 14 days)every three weeks for eight cycles.
16102718|NCT02142764|Biological|Blood samples|The blood will be sampled in order to be tested in Immunology, once, the day they sign their agreement (at the inclusion)
16103596|NCT02136082|Behavioral|Asha Support Only|
16102646|NCT02143375|Device|810 Diode Laser|The 810-nm diode laser has energy and wavelength characteristics that specially target the soft tissues. It has an affinity for hemoglobin and melanin, so it is an excellent soft tissue laser and is applicated for cutting and coagulating gingival tissue.Today,sparse studies have been published assessing physiologic gingival pigmentation using diode laser,therefore the aim of this study was to evaluate the effect of diode laser on the treatment of gingival pigmentation in adult patients.
16102647|NCT02143362|Drug|Anesthesia induction,propofol, remifentanil ,cisatracurium|"Target Controlled Infusion propofol and remifentanil to targeted plasma concentrations are 4 μg/ ml and 4 ng/ml respectively.
~Intermittent injection cisatracurium (0.15mg/kg).
~A laryngeal mask airway will be placed when bispectral electroencephalogram index is reduced to 60."
16102648|NCT02143362|Drug|Anesthesia maintenance , propofol,remifentanil,cisatracurium|"Closed-loop target controlled infusion of propofol ,Bispectral electroencephalogram index feedback value will be set at 50.
~Target Controlled Infusion remifentanil , targeted plasma concentrations are 3~6ng/ml ,maintain heart rate to 60~100 beats per minute and mean blood pressure to 70~105 mmHg.
~Intermittent injection cisatracurium (0.05mg/kg)."
16102649|NCT02143362|Procedure|Awaken test|"Stopped Closed-loop target controlled infusion of cisatracurium and propofol 30 minutes before awaken test.
~In dexmedetomidine group,dexmedetomidine infusion rate will be reduced to 0.1 μg•kg-1•h-1. In control group ,normal saline infusion will be given with the same infusion rate as dexmedetomidine group .
~Call patients' name and require them to move both feet every 30 seconds after patients recovered normal respiration.
~Patients will be considered to be awake when recover normal respiration and make responsive to verbal commands correctly .
~Patients will receive initial anesthesia after finish awaken test."
16102650|NCT02143349|Dietary Supplement|Coleus forskohlii extract|Ingestion of 250 mg Coleus forskohlii extract capsule twice a day for 12 weeks
16102651|NCT02143349|Other|Placebo|Ingestion of 250 mg placebo capsule twice a day for 12 weeks
16102652|NCT02143336|Procedure|subcuticular suture|
16102653|NCT02143336|Procedure|Skin staples|
16102654|NCT02143323|Drug|Augmentin tablet|
16102655|NCT02143310|Device|EVP|
16102656|NCT02143284|Device|Endoscopy exploratory single arm (EndoChoice FUSE(TM) System)|The investigational device will be applied in otherwise standard procedures (upper and lower Gastrointestinal tract endoscopy)
16102657|NCT02143271|Drug|KHK7580|Oral administration
16102658|NCT02143258|Procedure|Stenting of the venous sinus|Patients with medically refractory idiopathic intracranial hypertension who meet the eligibility criteria will be offered stenting of their venous sinus in effort to reduce their intracranial pressure and improve their visual capabilities.
16102659|NCT02143245|Diagnostic Test|Synovial Biopsy|Synovial biopsy is a procedure using a guided needle, where 6 to 8 small tissue samples with be extracted from the shoulder using an x-ray guided needle.
16102660|NCT02143245|Diagnostic Test|Open Tissue Biopsy|During the standard of care revision surgery, 6 to 8 small tissue samples will be taken in order to test for infection. This is standard of care treatment. As part of this study, an additional 1 to 2 samples of tissue would be taken in order to develop a test to determine more precisely what type of infection there may be.
16102661|NCT02143232|Device|remote patient monitoring (Telus RPM)|All joint replacement patients in the study will use the same type of remote patient monitor for 4 days post operation at home.
16102662|NCT02143219|Drug|Oxaliplatine|Oxaliplatine : 85mg/m², 2-hours IV infusion (D1), then,
16102663|NCT02143219|Drug|Folinic acid|Folinic acid (FA): 400 mg/m² , 2-hour IV infusion (D1),
16102664|NCT02143219|Drug|Irinotecan|"Irinotecan (at the dosage determined by the UGT1A1 status), 90 min IV infusion starting 30 min after the FA starts
~Homozygous 6/6 or 6/7: irinotecan will start at 150 mg/m², then will be increased according to clinical/biological tolerance by 10% steps, at each cycle, up to 180 mg/m² at max.
~Homozygous 7/7: irinotecan will start at 130 mg/m² in the first cycle then be increased up to a max of 150 mg/m², by 10% steps, according to tolerance."
16102665|NCT02143219|Drug|5-FU|"5-FU (according to the DPD pharmacogenetic status), continuous IV infusion of 46 hours, starting at the end of FA infusion:
~If no DPD deficiency, 5-FU start at 1600 mg/m² and can be modulated according to clinical/biological tolerance after each course, i.e., 1800 mg/m² the 2nd course and 2000 mg/m² the 3rd one
~If partial DPD deficiency: 5-FU start at 1200 mg/m² and can be increased up to 1800, then 2000 if the clinical/biological tolerance are good at the 2nd and 3rd course."
16102666|NCT02143193|Behavioral|Skin-to-Skin Contact|
16102667|NCT02143167|Drug|SR-fampridine|"One arm receives SR-fampridine 10 mg BID for 24 weeks followed by four weeks of inactive placebo BID.
~The other arm receives placebo BID for 24 weeks followed by four weeks of SR-fampridine 10 mg BID for four weeks."
16102668|NCT02143167|Drug|Placebo|
16102669|NCT02143141|Drug|duramorph|duramorph 150 mcg given with spinal anesthetic, then receipt of placebo capsules postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching.
16102670|NCT02143141|Drug|placebo|placebo in an equal volume to that of duramorph 150 mcg given with spinal anesthetic, then receipt of oral acetaminophen 1000mg during first 24 hours postoperatively. evaluation postoperative day 1 for measurement of itching, nausea, vomiting, pain and itching.
16102671|NCT02143115|Procedure|Optical colonoscopy|Examination of the colon with a colonoscope
16102672|NCT02143115|Radiation|CT-Colonography|A computerized X-ray that may find out if there are polyps or cancers and also pictures the contents of the abdomen and pelvis
16102673|NCT02143089|Device|Foley's Catheter|Urinary tract infection inpatient catheterized versus non catheterized
16102674|NCT02143076|Behavioral|Demographic Questionnaire|At study enrollment, participants will complete a questionnaire to collect demographic information about the participant's family background, education and living situation.
16102675|NCT02143076|Behavioral|Medical Adherence Measure Questionnaire|"At the two-month follow-up visit, participants will be asked to complete a questionnaire describing all medications prescribed for them, when they take their medications, how much medication they take each time, how many times during the week they missed taking or were late taking each medication, reasons why they missed or were late, and how they manage their medications.
~In the case that a participant's clinic schedule is delayed greater than two months from the time of consent (e.g., missed appointment, change in clinic appointment frequency), procedures scheduled for the anticipated 2-month visit will take place at the participant's next clinic appointment."
16103904|NCT02133976|Behavioral|behavioral therapy|
16102676|NCT02143076|Behavioral|Acceptability Questionnaire|"At the two-month follow-up visit, participants will be asked to complete a questionnaire about their perceptions of using the Wise electronic medication container.
~In the case that a participant's clinic schedule is delayed greater than two months from the time of consent (e.g., missed appointment, change in clinic appointment frequency), procedures scheduled for the anticipated 2-month visit will take place at the participant's next clinic appointment."
16102677|NCT02143063|Behavioral|prize contingency management on a traditional twice weekly schedule for cocaine abstinence|
16102678|NCT02143063|Behavioral|prize contingency management on a variable interval schedule for cocaine abstinence|
16102679|NCT02143063|Behavioral|standard care|
16102683|NCT02143037|Behavioral|prize contingency management for attending treatment|
16102684|NCT02143037|Behavioral|usual care|
16102685|NCT02143024|Behavioral|Family-based depression intervention|The primary focus of our approach is on effectively engaging family members of depressed older men in the care of the patient. The interventionist (social worker) will 1) work jointly with a family member and older men to strengthen depression self-management and participation during primary care visits and 2) conduct a brief training module for primary care provider skills to strengthen their skills in working with family members.
16102686|NCT02143024|Behavioral|Usual care plus educational materials|Control subjects will receive usual care in the clinic augmented by psychoeducation. Family members will be given standard psychoeducational materials on depression.
16102687|NCT02143011|Other|orange juice|intervention assigned: 2-week consumption of naturally-sweetened orange juice providing 25% of energy requirement
16102688|NCT02143011|Other|sucrose|intervention assigned: 2-week consumption of sucrose-sweetened beverage providing 25% of energy requirement
16102689|NCT02142998|Other|24 pH monitoring|The study is performed with the patient fasting for a minimum of 6 hours. A single channel or dual channel (15 cm spacing) pH probe is inserted trans nasally. The pH sensor, or distal pH sensor in the case of 2 channel testing, is positioned 5 cm above the proximal margin of the LES, as determined by esophageal manometric testing. pH-Z ambulatory monitor (Given Imaging Digitrapper) is used for data acquisition and the data analyzed with pH Analysis Program (Given Imaging AccuView). The number of reflux events, defined as a drop in esophageal pH readings below 4.0, is recorded and the percentage of time with esophageal acid exposure is analyzed using defined protocols and accepted normal values.
16102690|NCT02142998|Other|Esophageal Manometry:|A high resolution esophageal manometry catheter is used for testing and inserted Trans nasally. The patient is given 10 liquid swallows (5mL of water), at intervals of approximately 30 seconds. The catheter (Sierra Scientific/Given Imaging) has 36 sensors, each one averaging pressures from 12 circumferential positions. This gives a total of 432 data points. The sensors are placed 1 cm apart, spanning a length of 35 cm. The catheter simultaneously records pressure readings from the esophagus, sphincter regions (UES and LES), pharynx and stomach without the need for a station pull-through technique. Results are reported according to defined protocols and accepted normal values.
16102691|NCT02142985|Drug|Sodium Chloride 0.9% Intravenous|vascular filling with 500 ml of crystalloid solution (sodium chloride 0.9%) over 30 minutes
16102692|NCT02142959|Drug|Omaveloxolone Lotion 0.5%|Omaveloxolone lotion 0.5% will be applied topically twice-daily, for up to 13 weeks, during the course of radiation therapy
16102693|NCT02142959|Drug|Omaveloxolone Lotion 3%|Omaveloxolone lotion 3% will be applied topically twice-daily, for up to 13 weeks, during the course of radiation therapy
16102694|NCT02142959|Drug|Lotion vehicle/Placebo|Lotion vehicle manufactured to mimic RTA 408 lotion will be applied topically twice-daily, for up to 13 weeks, during the course of radiation therapy
16102695|NCT02142959|Radiation|3D conformal radiation therapy|45 50.4 Gy in 1.8 Gy per day, in addition to 10 - 16 Gy boost or 46 - 50 Gy in 2 Gy per day, in addition to 10 - 16 Gy boost, at the physician's discretion
16102696|NCT02142933|Other|vagino-perineal swab|
16102697|NCT02142920|Drug|PF-05212384|Single 89 mg Dose via 30 minute IV infusion
16102698|NCT02142894|Device|CST001|
16102699|NCT02142881|Other|Antihypertensive medication intensification|Antihypertensive medications will be adjusted by study staff based on ambulatory and clinic BP results at baseline and 2 months with a target 24hr systolic blood pressure of <130 mmHg.
16102700|NCT02142881|Other|Usual care|Antihypertensive medications will be adjusted by the participants' providers (usual care).
16102701|NCT02142868|Drug|Palbociclib|Palbociclib will be administered orally once a day at 125 mg/day for 21 days followed by 7 days off treatment for each 28-day cycle (Schedule 3/1)
16102702|NCT02142868|Drug|Letrozole|Letrozole will be administered orally at 2.5 mg once daily as continuous daily dosing schedule according to product labeling and in compliance with its local prescribing information.
16102703|NCT02142855|Behavioral|Concentric Exercise Training|8 weeks concentric exercise training, 3 x per week, 60% 1-RM; 4 x 12-15 repetitions, 2 min rest between sets
16102704|NCT02142855|Behavioral|Eccentric Exercise Training|8 weeks eccentric exercise training, 3 x per week, 60% 1-RM; 4 x 12-15 repetitions, 2 min rest between sets
16102705|NCT02142842|Biological|Autologous adipose tissue stromal vascular fraction and platelet rich plasma|
16102706|NCT02142829|Drug|EXPAREL|
16102707|NCT02142829|Drug|On-Q Pain Ball|bupivacaine HCl 0.25%
16102708|NCT02142816|Device|Doppler|Fluid therapy guided by doppler
16102709|NCT02142816|Other|PVI'|Fluid therapy guided by PVI
16102710|NCT02142803|Biological|Bevacizumab|Given IV
16102711|NCT02142803|Other|Laboratory Biomarker Analysis|Correlative studies
16102712|NCT02142803|Other|Pharmacological Study|Correlative studies
16102713|NCT02142803|Drug|Sapanisertib|Given PO
16102714|NCT02142790|Drug|paclitaxel liposome injection|
16102715|NCT02142777|Drug|S -Equol|We will determine if the intervention (S-equol) alters platelet mitochondria COX activity.
16102716|NCT02142777|Drug|Placebo|The placebo has no active ingredients but is made to look like the study drug.
16102717|NCT02142764|Biological|Blood samples|The blood will be sampled in order to be tested in Immunology, twice, the day they sign their agreement and six months after in case of positive myelin pentamer test (at inclusion and 6 months after the inclusion).
16103905|NCT02133976|Other|treatment as usual|
16102721|NCT02142751|Drug|Ceftriaxone intravenous|1g every 24 hours iv (2-4 min infusion) It depends on strain sensitivity: Strain with resistance to quinolone but sensitivity to cephalosporins
16102722|NCT02142738|Drug|Pembrolizumab|Pembrolizumab IV solution
16102723|NCT02142738|Drug|Paclitaxel|Paclitaxel IV solution
16102724|NCT02142738|Drug|Carboplatin|Carboplatin IV solution
16102725|NCT02142738|Drug|Pemetrexed|Pemetrexed IV solution
16102726|NCT02142738|Drug|Cisplatin|Cisplatin IV solution
16102727|NCT02142738|Drug|Gemcitabine|Gemcitabine IV solution
16102728|NCT02142725|Drug|LT-02|four times per day
16102729|NCT02142725|Drug|LT-02|two times per day
16102730|NCT02142725|Drug|Placebo|four times per day
16102731|NCT02142712|Drug|Diphenhydramine|Diphenhydramine 12.5 mg BID intravenous or 25 mg BID oral for 4 days along with current standard of care.
16102732|NCT02142712|Drug|Pantoprazole|Pantoprazole intravenous 40mg q daily as part of standard of care for stress ulcer prophylaxis along with current standard of care.
16102733|NCT02142712|Drug|Famotidine|Famotidine 40 mg intravenous BID (maximum dose of 80 mg/day) for 4 days as part of standard of care for stress ulcer prophylaxis along with current standard of care.
16102734|NCT02142712|Drug|Dextromethorphan|Dextromethorphan 60 mg QID orally (maximum dose of 240 mg/day) for 2 days (total of 4 doses) along with current standard of care. If the drug can't be given orally, then feeding tube (G-tube, NG Tube or DHT) will be used for drug administration.
16102735|NCT02142699|Drug|Heme arginate|
16102736|NCT02142686|Device|Filling pressure 80|After the hysteroscope is introduced into the uterine cavity, the filling pressure will remain at 80mm Hg.
16102737|NCT02142686|Device|Filling pressure 50|After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 50mm Hg.
16102738|NCT02142686|Device|Filling pressure 30|After the hysteroscope is introduced into the uterine cavity, the filling pressure will be reduced to 30mm
16102739|NCT02142673|Device|Filling pressure 80|The hysteroscope filling pressure will be 80mm Hg
16102740|NCT02142673|Device|Filling pressure 60|The hysteroscope filling pressure will be reduced to 50mm Hg
16102741|NCT02142673|Device|Filling pressure 40|The hysteroscope filling pressure will be 40mm Hg
16102742|NCT02142660|Procedure|ablation of gastric|Applied to the operating zone during an ablation of gastric died ring at obese patients programmed for the second bariatric surgery to type of bypass gastric or of gastrectomie in wing
16102743|NCT02142647|Behavioral|a high-protein complementary diet with meat|infants will consume a high-protein complementary diet with protein mainly from meat
16102744|NCT02142647|Behavioral|a high-protein complementary diet with dairy|infants will consume a high-protein complementary diet with protein mainly from dairy
16102745|NCT02142634|Drug|Budesonide granules 9 mg|per day
16102746|NCT02142634|Drug|Placebo granules|per day
16102747|NCT02142621|Other|transpyloric feeding|
16102748|NCT02142621|Other|gastric feeding|
16102749|NCT02142608|Drug|BR55|Ultrasound contrast agent
16102750|NCT02142595|Drug|dexmedetomidine|The sedative solution administered intravenously started at rate of kg (weight of patient)*0.6 ml/h over a 10-min period and then at rate of kg (weight of patient)*0.15 ml/h through syringe pump to the end of surgery
16102751|NCT02142595|Drug|Midazolam|The sedative solution administered intravenously started at rate of kg (weight of patient)*0.6 ml/h over a 10-min period and then at rate of kg (weight of patient)*0.15 ml/h through syringe pump to the end of surgery
16102752|NCT02142582|Dietary Supplement|WHO ORS|Participants will be randomized into one of the two groups. They will be provided with one of the two ORS solutions. Then, they will be followed for 6 months.
16102753|NCT02142582|Dietary Supplement|Commercial ORS|Participants will be instructed to dilute contents of the provided ORS to a 1 liter bottle and sip all day.
16102754|NCT02142569|Drug|Sugar Pill|Sugar Pills/Placebo 4 capsules/day for 12 weeks.
16102755|NCT02142569|Drug|Chinese Red Yeast Rice (CRYR)|CRYR 1200mg/day, including 6 mg mevinolin as Monacolin K (2 capsules) + placebo (2 capsules) for 12 weeks.
16102756|NCT02142569|Drug|CRYR + TRF|CRYR 1200mg/day, including 6 mg mevinolin as Monacolin K (2 capsules) + TRF 300mg/day including 60 mg tocotrienols (2 capsules) per day for 12 weeks.
16102757|NCT02142569|Device|Tocotrienol-enriched Fraction of Palm Oil (TRF)|TRF 300mg/day, including 60 mg tocotrienols (2 capsules) + placebo (2 capsules) per day for 12 weeks.
16102758|NCT02142556|Drug|Administration of quetiapine XR|The treatment was initiated with a 7-day cross-titration period. Previous antipsychotic medication was maintained at the original dose from day 1 to day 3; then reduced to 50% of the original dose from day 4 to day 7 and discontinued on day 8. Meanwhile, the patients started quetiapine XR with daily dose at 300 mg on day 1, 600 mg on day 2 and up to 800 mg after day 2. From day 8 until the end of the study, the dose of quetiapine XR was adjusted within 400-800 mg per day, depending on the clinical response and tolerability of the patients.
16102759|NCT02142543|Drug|2-DeNT powder|powder included dexamethasone, diphenhydramine, tetracycline, metronidazole, nystatin, zinc oxide, and karaya gum
16102760|NCT02142543|Drug|Placebo Comparator|
16102761|NCT02142530|Drug|Carfilzomib|
16102762|NCT02142530|Drug|Belinostat|
16102763|NCT02142517|Procedure|Duct to mucosa PJ group|Duct to mucosa PJ was performed by a two layer end to side PJ. The pancreatic capsule and jejunal serosa were anastomosed by interrupted silk suture 3/0 to form the outer layer in both the anterior and posterior wall of the anastomosis. Jejunostomy was done matched to the pancreatic duct diameter. The inner layer duct to mucosa was performed in eight to twelve stitches with 5/0 prolene. A pancreatic duct stent was inserted during anastomosis to allow easy and accurate suture placement, ensure adequate pancreatic duct exposure, and protect the opposite wall from being inadvertently held by needles then it was removed at the end of anastomosis.
16102824|NCT02141854|Drug|FS MDPI|"FS MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate and salmeterol xinafoate dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened.
~During the treatment period, participants were randomized to either fluticasone propionate/salmeterol MDPI 200/12.5 mcg or fluticasone propionate/salmeterol MDPI 100/12.5 mcg twice a day for a total daily dose of 200/25 mcg or 400/25 mcg.
~Participants were instructed to rinse their mouth and expectorate (not swallow) after study drug administration."
16102764|NCT02142517|Procedure|Invagination PJ group|Invagination PJ was performed as an end to side. The pancreatic capsule and jejunal serosa were anastomosed by interrupted silk suture 3/0 to form the outer layer in both the anterior and posterior wall of the anastomosis. Jejunostomy was done matched to the pancreatic stump diameter. The inner layer was performed with 5/0 prolene between pancreatic parenchyma and mucosa. The duct was taken posteriorly and anteriorly to jejunal mucosa. A pancreatic duct stent was inserted during anastomosis and removed at the end of taking the stitches. Reconstruction was completed by end to side hepaticojejunostomy (retrocolic) and gastrojejunostomy (GJ) (antecolic) end to side manually.
16102765|NCT02142504|Biological|Norovirus Bivalent VLP Vaccine|Norovirus GI.1/GII.4 bivalent VLP vaccine adjuvanted with or without MPL and/or aluminum hydroxide IM injection
16102766|NCT02142504|Drug|Placebo (Saline)|Placebo-matching norovirus bivalent VLP vaccine
16102767|NCT02142478|Behavioral|Adapted Exercise for Health (EFH) scheme|"12-week subsidised exercise programme at local authority-run leisure centres. Each participant receives a programme of activities tailored to their needs, based on a standard recommendation of two exercise sessions per week. In February 2012, Centre A introduced some changes to the EFH scheme as follows:
~Pre-scheme meeting with a health trainer to help the patient decide if EFH is for them.
~Participants offered specially tailored group classes (exclusive to EFH participants, e.g. low-impact circuits, Zumba) as well as access to the main gym.
~Opportunities to attend daily.
~Although subsidised access to mainstream group classes and swim sessions (i.e. includes all leisure centre members) is also available, this option is not openly advertised on the adapted scheme."
16102768|NCT02142478|Behavioral|Standard Exercise for Health (EFH) scheme|"12-week subsidised exercise programme at local authority-run leisure centres. Each participant receives a programme of activities tailored to their needs, based on a standard recommendation of two exercise sessions per week.
~The scheme includes exclusive EFH gym sessions (i.e. includes EFH participants only) on two to three days of the week, plus subsidised access to mainstream group classes and swim sessions (i.e. includes all leisure centre members)."
16102769|NCT02142452|Behavioral|behavioral intervention|Behavioral intervention will include a group class for women in their 3rd trimester followed by a mobile texting program to support behavior change postpartum.
16102770|NCT02142452|Other|Usual Prenatal Care|
16102771|NCT02142439|Behavioral|Strength training|Three times per week with strength training
16102772|NCT02142400|Drug|DS-1093|DS-1093 in capsules with 2.5mg or 25mg per capsule
16102773|NCT02142400|Drug|placebo|matching placebo capsules to DS-1093 capsules
16102774|NCT02142387|Other|BLS CPR program with dispatcher assisted CPR simulation|the training program more focuses on cooperation with a dispatcher, from recognition to perform DA-CPR and hands-on practice.
16102775|NCT02142361|Device|enfilcon A|Silicone hydrogel toric lenses.
16102776|NCT02142335|Drug|Rituxan|The dose of Rituxan is 375 mg/m2¬ administered as an IV infusion during weeks 1 & 3 (days 1 & 15)Abraxane will be administered at a fixed dose of 100 mg/m2 as an IV infusion weekly for three weeks in a row followed by one week of rest
16102777|NCT02142322|Drug|MODIFIED FOLFOX6|Modified FOLFOX6 regimen consists of oxaliplatin 100 mg/m2 and FA 100 mg/m2 given as a 2 hour intravenous infusion, followed by 5-FU 2.4 g/m2 given as a continuous infusion over 46 hour, repeated every 2 weeks. Patients receive 4 cycles of neoadjuvant modified FOLFOX6 followed by curative radical surgery with D2 dissection and 4 cycles of adjuvant modified FOLFOX6.
16102778|NCT02142309|Drug|Glimepiride|Weekly adjustment based on self-monitoring of blood glucose level to a maximum of 4 mg daily
16102779|NCT02142309|Drug|Vildagliptin|Reduce to 50 mg if estimated glomerular filtration rate (eGFR) <45 mL/min
16102780|NCT02142309|Drug|Pioglitazone|Start with 15 mg/day and advance to 30 mg/day
16102781|NCT02142309|Drug|Canagliflozin|Start with 200 mg/day and advance to 300 mg/day on the basis of fasting glucose monitoring
16102782|NCT02142296|Drug|Eylea|monthly injections for 3 months and then every other month to 1 year. volume administered is 0.05ml
16102783|NCT02142283|Device|Trevo Thrombectomy Procedure|stent retriever; intended to restore blood flow in the neurovasculature by removing thrombus (clot)
16102784|NCT02142283|Other|Medical Management|Standard of Care not including mechanical thrombectomy, no intra arterial treatment, may include aspirin, therapy etc
16102785|NCT02142257|Procedure|Gastric Bypass|Gastric Bypass surgery reduces the size of the stomach by use of staples. The smaller gastric pouch is then connected to the intestine bypassing a portion of the small intestine.
16102786|NCT02142257|Device|AspireAssist Aspiration Therapy|AspireAssist employs an endoscopically placed A-Tube (similar to a gastrostomy tube) and a Companion system which facilitates portion control by aspiration of stomach contents 20 minutes after each meal combined with behavioral Therapy.
16102787|NCT02142244|Procedure|Near infra red sentinel node biopsy|Explicated in the protocol arm
16102788|NCT02142244|Drug|Indocyanine green|Explicated in the protocol arm
16102789|NCT02142244|Device|Intraoperative Near-Infrared Imaging System|Explicated in the protocol arm
16102790|NCT02142231|Device|Acupuncture|Sterile Acupuncture Needles (Seirin (R) 0.15x0.2) will be used, Needles are inserted for approx. 0.5-1 cm until deqi response is elicited
16102791|NCT02142231|Device|Laser Acupuncture|Therefore a laser irradiation is faked, approaching a nonfunctioning laser pen, which has been deactivated by the manufacturer (3B Scientific GmbH, Hamburg, Germany). Only red light is emitted. To further emphasize the imaginary power of this sham procedure, visual and acoustic signals accompany the red light emission. Patients are treated at the same acupuncture points as in the acupuncture group for one minute without skin contact. The resting time after treatment is 18 minutes.
16102792|NCT02142218|Drug|Nivolumab|
16102793|NCT02142205|Biological|BG00002|IV Infusion
16102794|NCT02142192|Drug|natalizumab|Administered as specified in the treatment arm
16102825|NCT02141854|Drug|Fp MDPI|"Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened.
~During the treatment period, participants were randomized to either 200 mcg or 100 mcg of Fp one inhalation twice a day for a total daily dose of 400 mcg or 200 mcg.
~Participants were instructed to rinse their mouth and expectorate (not swallow) after study drug administration."
16102869|NCT02141581|Biological|Fluzone® (IM)|This vaccine is given intramuscularly (IM)
16105535|NCT02121717|Drug|Chiglitazar|Take orally
16102795|NCT02142179|Behavioral|Knowledge about Asthma and Respiratory Education (KARE)|KARE - Knowledge about Asthma and Respiratory Education is an educational curriculum intervention organized with school staff to be applied to the intervention group. This intervention will consist of theoretical - practical weekly workshops with a targeted content for asthma and involves aspects related to anatomy and physiology of the respiratory tract, conceptualization of asthma, prevention, treatment, maintenance and retrieval; recognition and actions in periods of exacerbations and use the action plan. These workshops are suitable for the course plan of disciplines sciences, biology, chemistry, physics, history, geography, portuguese and mathematics. Those are characterized as a mandatory curriculum component and they should be developed for all students.
16102796|NCT02142166|Procedure|Biomarker in serum, liquor, micro-dialysate|Daily (21 days) analysis of biomarker in serum, in liquor and in micro-dialysate
16102797|NCT02142166|Procedure|Biomarker in serum and in liquor|Single analysis of biomarker in serum and liquor
16102798|NCT02142153|Drug|F901318|"Comparison of adverse events, clinically significant safety laboratory abnormalities and ECG abnormalities.
~Pharmacokinetic profile"
16102799|NCT02142153|Drug|Placebo|Comparison of adverse events and clinically sign significant safety lab and ECG abnormalities
16102800|NCT02142140|Behavioral|Academic and Organization skills|This program aims at teaching children organization, time management and stress management skills. They are also taught academic strategies in reading, writing, and math. The program consists of six, 90 minute sessions.
16102801|NCT02142140|Behavioral|Parent Training|The Parent Training Program: The parent training program is designed to increase parental understanding of ADHD; establish attentive, positive interactions, and solve problems collaboratively. Eight weekly group sessions lasting about 2 hours each will be conducted by trained psychologists, social workers, or clinical nurses. Homework assignments and detailed summary sheets will be used to promote technique acquisition and generalization.
16102802|NCT02142140|Behavioral|Social Skills Training|Social Skills and Anger Management Training: The social skills training program is based on understanding yourself and others, and being able to understand things from the other's perspective. The program uses direct instruction, modelling, behavioural rehearsal, feedback, and social reinforcement. The following are covered: joining in, understanding emotions, dealing with anger, using self-control, responding to teasing / bullying, and staying out of fights.
16102803|NCT02142140|Drug|Long-acting stimulant|The medication prescribed is usually a long-acting stimulant that is carefully titrated to the child's optimal dose (normally that dose above which further improvement is not seen and side effects are manageable). Once optimal dose is reached, children are followed at regular once per three month visits for medication monitoring. In this group the child can be referred for a medication reevaluation and adjustment as many times as is needed.
16102804|NCT02142140|Drug|Long-acting stimulant|The medication prescribed is usually a long-acting stimulant that is carefully titrated to the child's optimal dose (normally that dose above which further improvement is not seen and side effects are manageable). Once optimal dose is reached, children are followed by their pediatrician, with a frequency at his/her discretion.
16102805|NCT02142127|Drug|14C-labelled GFT505 120 mg|
16102806|NCT02142114|Device|Eye injection by 30 or 32 gauge needle|Consented patients receiving monthly bi-lateral injections of the same dose of ranibizumab will have one eye injected with a 30 gauge needle and the other eye injected with a 32 gauge needle. Bi-lateral injections may be performed on the same day or with one week of each other, depending on the subject preference and their normal injection regimen. On the first visit following enrollment in the study, the eye to receive the injection from the 30 or 32 gauge needle will be determined randomly. The other eye will be injected with the other needle size. When the patient returns for their next set of bi-lateral injections, the eyes receiving the 30 and 32 gauge needle injection will switch.
16102807|NCT02142088|Device|GlySure Intravascular Continuous glucose monitoring sensor|Comparator device is an iSTAT device from Abbott Diagnostics
16102808|NCT02142075|Drug|Daptomycin|
16102809|NCT02142049|Drug|Ibrutinib|Ibrutinib
16102810|NCT02142049|Drug|DA-EPOCH-R|Etoposide, Prednisone, Doxorubicin, Cyclophosphamide, Vincristine, Rituximab, Pegfilgrastim
16102811|NCT02142049|Drug|Lenalidomide|Lenalidomide
16102812|NCT02142036|Drug|EMA-approved ATI based targeted therapy|All drugs that may be used in the study are approved by EMA for treatment of disseminated cancer in the palliative setting, but not for the particular tumor type in question.
16102813|NCT02142010|Drug|paclitaxel liposome injection plus cisplatin|Paclitaxel liposome injection 80 mg/m2, given on days 1, 8,15 and 22 of a 28-day cycle. Cisplatin 25 mg/m2, given on days 1, 8 and 15 of a 28-day cycle, for 4 cycles(4 months)
16102814|NCT02141997|Biological|adalimumab|adalimumab administered as subcutaneous injection every other week (EOW)
16102815|NCT02141997|Biological|ABT-122|ABT-122 administered as subcutaneous injection every other week (EOW)
16102816|NCT02141958|Drug|Fenretinide|Fenretinide oral capsules of 100mg, each selected dose being administered once daily for 21 days (treatment cycle). Up to three total daily dose levels will be assessed in the study, as follows: 100mg of Fenretinide (one capsule) for the first treatment cycle, 200mg of Fenretinide (two capsules) in the second treatment cycle, and 300mg or 400mg of Fenretinide (3 or 4 capsules) will be selected for the third treatment cycle, based on safety and PK data collected.
16102817|NCT02141958|Drug|Placebo|A matching placebo will be used to keep the study double-blind.
16102818|NCT02141932|Procedure|Bed-side pocket size ultrasound imaging|
16102819|NCT02141932|Device|GE Ultrasound Vscan|
16102821|NCT02141906|Other|Oncozene-DEB-TACE|ONCOZENE microspheres are the newly available microspheres for DEB-TACE. It appears (based on the preliminary bench tests) that these microspheres may allow more efficient drug loading, and slow elution and equivalent vascular occlusion(12). In this pilot study, we aim to assess the safety of these microspheres when used for chemoembolization of unresectable hepatocellular carcinoma.
16102822|NCT02141893|Behavioral|CALMA plus|Participants received a family education intervention (previously tested) known as CALMA plus physician education and organizational change of the clinics were addressed with a culturally tailored program developed by adapting content from several evidence-based provider training programs
16102823|NCT02141893|Behavioral|CALMA|Family Education Intervention on management of pediatric asthma
16102826|NCT02141854|Drug|Placebo MDPI|The placebo multidose dry powder inhaler (MDPI) was identical to the devices used to deliver active drug, and indistinguishable from the active treatments. Patients took one inhalation twice a day (approximately 12 hours apart). Patients were instructed to rinse their mouth and expectorate (not swallow) after study drug administration.
16102827|NCT02141854|Drug|Albuterol/salmeterol HFA MDI|Albuterol/salmeterol hydrofluoroalkane (HFA) metered dose inhaler (MDI) was supplied to participants throughout the study to be used as needed as a rescue medication.
16102828|NCT02141828|Drug|EPZ-5676|28-day continuous IV infusion of each 28-day cycle, given until disease progression or unacceptable toxicity develops.
16102829|NCT02141815|Dietary Supplement|Arabinoxylan-oligosaccharides|
16102830|NCT02141815|Dietary Supplement|Maltodextrine|
16102831|NCT02141802|Behavioral|Doubling standing time|Doubling standing time using child's previously prescribed standing frame with a progression of 10% increase in time/month up to 2 hrs/day maximum
16102832|NCT02141802|Behavioral|control|Continue with usual standing time with a progression of 10% increase in time/month up to 1 hr/day maximum
16102833|NCT02141789|Behavioral|Outpatient Cognitive Behavioral Psychotherapy|Integrated CBT intervention for alcohol dependence and comorbid psychiatric disorder (we include only patients with comorbid mood or anxiety disorders).
16102834|NCT02141789|Behavioral|Outpatient Cognitive Behavioral Psychotherapy|The intervention is a well established form of psychotherapy that has infrequently been used in the German system with this group of patients in contrast to many other countries where it is the standard approach, e.g. the US.
16102835|NCT02141776|Device|Transcranial direct current stimulation (t-DCS)|The subjects randomized to this group will receive anodal t-DCS stimulation daily for four weeks. The stimulation parameters: current 2 mA continuously for 30 minutes.
16102836|NCT02141776|Other|Sham Controlled Arm|The subjects randomized to this group will not receive stimulation daily for four weeks.
16102837|NCT02141763|Drug|UCB4940 40 mg|"Active Substance: UCB4940
~Pharmaceutical Form: solution
~Concentration: vials at 80 mg/mL will be diluted with 0.9 % sodium chloride to a final concentration calculated to achieve the correct dose
~Route of Administration: intravenous"
16102838|NCT02141763|Drug|UCB4940 80 mg|"Active Substance: UCB4940
~Pharmaceutical Form: solution
~Concentration: vials at 80 mg/mL will be diluted with 0.9 % sodium chloride to a final concentration calculated to achieve the correct dose
~Route of Administration: intravenous"
16102839|NCT02141763|Drug|UCB4940 160 mg|"Active Substance: UCB4940
~Pharmaceutical Form: solution
~Concentration: vials at 80 mg/mL will be diluted with 0.9 % sodium chloride to a final concentration calculated to achieve the correct dose
~Route of Administration: intravenous"
16102840|NCT02141763|Drug|UCB4940 240 mg|"Active Substance: UCB4940
~Pharmaceutical Form: solution
~Concentration: vials at 80 mg/mL will be diluted with 0.9 % sodium chloride to a final concentration calculated to achieve the correct dose
~Route of Administration: intravenous"
16102841|NCT02141763|Drug|UCB4940 320 mg|"Active Substance: UCB4940
~Pharmaceutical Form: solution
~Concentration: vials at 80 mg/mL will be diluted with 0.9 % sodium chloride to a final concentration calculated to achieve the correct dose
~Route of Administration: intravenous"
16102842|NCT02141763|Drug|UCB4940 560 mg|"Active Substance: UCB4940
~Pharmaceutical Form: solution
~Concentration: vials at 80 mg/mL will be diluted with 0.9 % sodium chloride to a final concentration calculated to achieve the correct dose
~Route of Administration: intravenous"
16102843|NCT02141763|Other|Placebo|"Pharmaceutical Form: solution
~Concentration: 0.9 % sodium chloride
~Route of Administration: intravenous"
16102844|NCT02141737|Drug|Lidocaine Hydrochloride Injection|Lidocaine injection should be give before the injection of etomidate. In groups L1 and L2, 20 mg and 30 mg lidocaine injection will be diluted to 2ml separately.
16102845|NCT02141737|Drug|Etomidate Fat Emulsion Injection|1 minute after the injection of lidocaine, 0.3 mg/kg etomidate will be given in 30 to 60 s.
16102846|NCT02141737|Drug|normal saline|2 ml normal saline will be given 1 minute before the injection of etomidate in patients in group C, and in group L1 and L2, normal saline is used to dilute lidocaine injection to 2 ml.
16102847|NCT02141737|Drug|Midazolam Injection|0.02 mg/kg midazolam will be given to the patients in all groups 90 s after the injection of etomidate.
16102848|NCT02141737|Drug|Fentanyl Citrate Injection|3 μg/kg fentanyl will be given to patients in all groups after the injection of midazolam.
16102849|NCT02141737|Drug|Rocuronium Injection|0.6 mg/kg rocuronium will be given to patients in all groups after the injection of fentanyl.
16102850|NCT02141724|Other|Positioning consultation|Assessment of pain,bedsores and postural troubles
16102851|NCT02141711|Drug|TAK-438|TAK-438 tablets
16102852|NCT02141711|Drug|TAK-438 Placebo|TAK-438 placebo-matching tablets
16102853|NCT02141698|Drug|TAK-438|TAK-438 tablets
16102854|NCT02141698|Drug|TAK-438 Placebo|TAK-438 placebo-matching tablets
16102855|NCT02141698|Drug|Esomeprazole|Esomeprazole tablets
16102856|NCT02141672|Drug|Voclosporin High Dose|
16102857|NCT02141672|Drug|Voclosporin Low Dose|
16102858|NCT02141672|Drug|Placebo|
16102859|NCT02141659|Drug|TAK-385|TAK-385 Tablets.
16102860|NCT02141646|Behavioral|Motivational Interviewing|The main goals of motivational interviewing are to engage clients, elicit change talk, and evoke motivation to make positive changes from the client.
16102861|NCT02141646|Behavioral|Behavioral Skills Training|Behavioral Skills Training (BST) is a training package that utilizes instructions, modeling, rehearsal, and feedback in order to teach a new skill.
16102862|NCT02141633|Procedure|echocardiogram plus albuterol|participants will performed echocardiogram before and 15 minutes after inhaled albuterol
16102863|NCT02141633|Procedure|airway blood flow plus albuterol|participants will performed echocardiogram before and 15 minutes after inhaled albuterol
16102864|NCT02141633|Drug|Fluticasone propionate|participant will be received a 4-week course of inhaled fluticasone (220 μg fluticasone twice a day administered as a MDI using a spacer)
16102865|NCT02141633|Drug|placebo|participant will be received a 4-week course of identically appearing placebo (2 puffs twice a day via spacer).
16102866|NCT02141620|Drug|Cocaine|The pharmacodynamic effects of cocaine will be determined during maintenance on placebo and n-acetylcysteine.
16102867|NCT02141620|Drug|n-Acetylcysteine|
16102868|NCT02141620|Drug|Placebo|
16102870|NCT02141581|Biological|Fluzone® Intradermal (ID)|This vaccine is given intradermally (ID)
16102871|NCT02141581|Biological|2011-2012 FluMist®|This vaccine is given intranasally
16102872|NCT02141568|Other|Medical and Psychological treatment|"Medical and psychological treatment by the staff of the functional neurology clinic at Soroka UMC. This treatment will include an initial visit to the staff neurologist and further multidisciplinary treatment as per his decision (the team includes a psychologist and a physical therapist)."
16102873|NCT02141555|Drug|Vaginal Misoprostol|Misoprostol inserted into vagina
16102874|NCT02141555|Drug|Buccal Misoprostol|Misoprostol placed between the gum and cheek and allowed to dissolve for 30 minutes with the remnants swallowed after this time.
16102875|NCT02141542|Drug|Tremelimumab|
16102876|NCT02141542|Drug|MEDI3617|
16102877|NCT02141529|Procedure|Unipolar pulsed radiofrequency thermocoagulation|Unipolar pulsed radiofrequency thermocoagulation, intraarticular administration into the knee joint
16102878|NCT02141529|Procedure|Bipolar pulsed radiofrequency thermocoagulation|Bipolar pulsed radiofrequency thermocoagulation, intraarticular administration into the knee joint
16102879|NCT02141516|Biological|rMenB+OMV|2 doses of vaccine 2 months apart
16102880|NCT02141516|Biological|rMenB+OMV|2 doses of vaccine 2 months apart
16102881|NCT02141516|Biological|rMenB+OMV|2 doses of vaccine 2 months apart
16102882|NCT02141490|Drug|Ferumoxytol|7.5mg/kg intravenous (IV) infusion
16102883|NCT02141490|Diagnostic Test|Magnetic Resonance Imaging (MRI)|3 MRIs: pre-infusion, 24 and 48 hours post-infusion
16102884|NCT02141477|Drug|Omacetaxine|Phase I and Phase II Omacetaxine Dose: 1.25 mg/m2 subcutaneously every 12 hours on Days 1 - 3 of a 28 day cycle.
16102885|NCT02141477|Drug|Decitabine|"Phase I Starting Decitabine Dose: 20 mg/m2 by vein on Days 1 - 5 of a 28 day cycle.
~Phase II Starting Decitabine Dose: Maximum tolerated dose from Phase I."
16102886|NCT02141451|Drug|Rituximab|Rituximab 375 mg/m2 IV after day +28 (as late as day 75) re-staging and again 1 and 7 weeks later
16102887|NCT02141451|Drug|INCB7839|INCB7839 at assigned dose twice daily for 90 days - begin the morning of the 2nd dose of rituximab
16102889|NCT02141425|Drug|ASP015K|oral
16102890|NCT02141425|Drug|Placebo|oral
16102891|NCT02141412|Drug|dexmedetomidine 0.25 µg/kg IV|
16102892|NCT02141412|Drug|dexmedetomidine 0.5 µg/kg IV|
16102893|NCT02141412|Drug|dexmedetomidine 1 µg/kg IV|
16102894|NCT02141412|Drug|Placebo Comparator|Patients in Group IV will receive same volume of normal saline at closure of sevoflurane
16102895|NCT02141399|Drug|ALKS 5461|Sublingual tablet, taken daily
16102896|NCT02141386|Other|PACR (Plasticity-based, Adaptive, Computerized Cognitive Remediation)|
16102897|NCT02141373|Device|Glubran 2|
16102898|NCT02141360|Device|MRI Diagnostic|Commercially available MRI scanner using investigational or standard of care MR coils and a series of investigational Application Packs containing a predetermined set of MRI pulse sequences
16102899|NCT02141347|Drug|Tremelimumab|Tremelimumab administered intravenously
16102900|NCT02141347|Drug|MEDI4736|MEDI4736 administered intravenously.
16102901|NCT02141321|Drug|Misoprostol|
16102902|NCT02141321|Drug|Placebo|
16102903|NCT02141295|Drug|5-FU|5-FU will be administered according to dose and schedule described in respective arm.
16102904|NCT02141295|Drug|Bevacizumab|Bevacizumab will be administered according to dose and schedule described in respective arm.
16102905|NCT02141295|Drug|Folinic acid|Folinic acid will be administered according to dose and schedule described in respective arm.
16102906|NCT02141295|Drug|Oxaliplatin|Oxaliplatin will be administered according to dose and schedule described in respective arm.
16102907|NCT02141295|Drug|Vanucizumab|Vanucizumab will be administered according to dose and schedule described in respective arm.
16102908|NCT02141282|Drug|ABT-199|ABT-199 monotherapy
16102909|NCT02141256|Dietary Supplement|Protein enriched products|Newly developed products with extra protein. Specially developed for elderly.
16102910|NCT02141243|Procedure|Lingual Frenotomy|For newborns receiving the ankyloglossia frenotomy, the tongue will be elevated and the frenulum exposed with a grooved director or 2 cotton tipped applicators. The frenulum tissue will then be incised with a straight scissor. If thick, it will be crushed with a straight clamp to provide anesthesia and decrease bleeding, and the exposed and previously clamped tongue frenulum will be incised with a straight scissor.
16102911|NCT02141243|Procedure|Labial Frenotomy|For newborns receiving the maxillary labial frenotomy, 0.1 ml of 1% lidocaine will be injected into the area. The upper lip will be lifted and the frenum stretched. Then an iLaseTM 940 ± 15 nm laser will be used to release its attachment to the level of the periosteum.
16102912|NCT02141243|Procedure|Sham Procedure|For newborns receiving the maxillary labial frenotomy, 0.1 ml of 1% lidocaine will be injected into the area. The upper lip will be lifted and the frenum stretched. Then an iLaseTM 940 ± 15 nm laser will be used to release its attachment to the level of the periosteum.
16102913|NCT02141230|Drug|Alli® 60 mg|Participants purchasing Alli®
16102914|NCT02141217|Drug|Amoxicillin/clavulanate|Amoxicillin/clavulanate 1 g bd for at least 5 days or maximum 7 days depending upon the treatment response.
16102915|NCT02141217|Drug|Clindamycin|Clindamycin 150 mg qid for at least 5 days or maximum 7 days depending upon the treatment response.
16102916|NCT02141204|Biological|HRV Liquid|Two doses administered orally according to a 0, 1-month schedule.
16102917|NCT02141204|Biological|HRV Lyophilized|Two doses administered orally according to a 0, 1-month schedule.
16102918|NCT02141191|Drug|inhaled hypertonic saline (7%)|Inhaled hypertonic saline delivered by nasal cannula using the Parion transnasal Pulmonary Aerosol Delivery (tPAD) device
16102919|NCT02141178|Drug|Bupivacaine|
16102920|NCT02141178|Drug|Exparel|
16102921|NCT02141165|Device|Diagnosis, autoCPAP, follow up.|comparison between the efficacy of two protocol
16102922|NCT02141139|Drug|NSAIDS (ketorolac and ibuprofen)|
16102923|NCT02141126|Other|Resistance training|Usual physiotherapy care and twice weekly tailored and progressive resistance lower limb exercises Circuit-type format, sessions will last 35 minutes and will include a warm-up and cool-down period. Exercises tailored to each patient and will use ankle weights as the resistance, using 65-75% of their 1-Repetition Maximum. Intervention will last for 6 weeks.
16102924|NCT02141126|Other|Usual care|Standard inpatient 'usual care' physiotherapy
16102925|NCT02141113|Drug|Guanfacine Hydrocholride|"mg Guanfacine Hydrochloride (orally)
~mg Guanfacine Hydrochloride (orally)
~mg Guanfacine Hydrochloride (orally)
~mg Guanfacine Hydrochloride (orally)
~mg Guanfacine Hydrochloride (orally)
~mg Guanfacine Hydrochloride (orally)"
16102926|NCT02141113|Drug|Guanfacine Hydrocholride|"mg Guanfacine Hydrochloride (orally)
~mg Guanfacine Hydrochloride (orally)
~mg Guanfacine Hydrochloride (orally)
~mg Guanfacine Hydrochloride (orally)
~mg Guanfacine Hydrochloride (orally)
~mg Guanfacine Hydrochloride (orally)"
16102927|NCT02141100|Drug|6-thioguanine|"All eligible patients will be supplemented with 6-thioguanine in addition to the standard therapy with 6-mercaptopurine and methotrexate.
~In case of significant myelo-/hepatotoxicity all therapy will be paused. If patients develop VOD they will be excluded from further 6TG therapy."
16102928|NCT02141087|Drug|Pirfenidone|
16102930|NCT02141061|Drug|Telapristone Acetate, Proellex 12 mg Formulation A|
16102931|NCT02141061|Drug|Telapristone Acetate, Proellex 12 mg Formulation B|
16102932|NCT02141048|Behavioral|Positive Parenting Skills Training|This parenting programme is delivered by facilitators from the Parent Centre. It is intended for any caregivers of children between the ages of 6-12 years. It consists of seven weekly 3-hour sessions, and is group-based. Once the group size reaches 20 or more people sessions are co-facilitated. The first session provides an overview of the programme. The remaining sessions consider topics including: factors that affect child behaviour, understanding children's feelings, building children's self-esteem, assertive parenting, gaining child-co-operation, effective discipline, and problem solving. The programme is knowledge-based and encourages the development of various parenting skills through the inclusion of experiential activities (e.g., role-plays and homework practice).
16102933|NCT02141035|Drug|Acetyl-l-carnitine|Those randomized to the treatment arm will receive the medication at 1 g tid for 60 days
16102934|NCT02141035|Drug|placebo|The control subjects will receive placebo tablets that are identical in appearance and taste to the active medication tid for 60 days
16102935|NCT02141022|Other|plasticity-based computerized cognitive remediation program|
16102936|NCT02141022|Drug|Gileyna|
16102937|NCT02141009|Biological|Prevnar 13|
16102938|NCT02140996|Drug|Ad-sig-hMUC-1/ecdCD40L vector vaccine|
16102939|NCT02140983|Drug|Liraglutide|90 days of liraglutide up to 1.8mg/day.
16102940|NCT02140983|Drug|Placebo|Placebo medication
16102941|NCT02140970|Drug|Ibuprofen|10 mg/kg orally up to a maximum of 400 mg given once at least 15 minutes prior to ureteral stent removal
16102942|NCT02140970|Drug|Placebo|Similar-tasting and appearing liquid placebo of equal volume to be given once orally at least 15 minutes prior to ureteral stent removal
16102943|NCT02140957|Behavioral|Educational Intervention|Parents of children in both intervention and control groups received standardized counseling on healthy nutrition based on Canadian Paediatric Society guidelines. In addition, during the same 9-month doctors visit, parents of infants allocated to the intervention group were given a sip cup (Avent Magic CupTM) and shown how to use it. A trained research assistant told intervention group parents the risks of continued bottle use. They were also instructed to limit daily milk consumption to 16 ounces. Parents were also counseled to discontinue bottle use in the next 1 week using a step-wise protocol described on a handout to be placed on their refrigerator. Parents of infants allocated to the control group did not receive this information.
16102944|NCT02140931|Drug|Injections|Intra-muscular injections
16102945|NCT02140918|Drug|Fludrocortisone 100 μg|Fludrocortisone 100 μg/day
16102946|NCT02140918|Drug|Fludrocortisone 200 μg|Fludrocortisone 200 μg/day
16102947|NCT02140918|Drug|Fludrocortisone 400 μg|Fludrocortisone 400 μg/day
16102948|NCT02140918|Drug|Placebo|
16102949|NCT02140892|Procedure|respiratory physical therapy manual technique- Autogenic Drainage|
16102950|NCT02140892|Device|respiratory physical therapy technique- IPV|
16102951|NCT02140879|Dietary Supplement|Capsule 1 or Capsule 2|Capsules will be consumed on a daily basis during pregnancy. One group, the placebo group of the study, will take capsules (2/day) containing oil '1 ' which is a mixture of corn and soy oils . The other group, the supplement group, will take capsules containing oil '2' which is an algal oil. Both oils are found in our diets.
16102952|NCT02140879|Dietary Supplement|Capsule 2|Two capsules will be consumed on a daily basis during pregnancy. The other group, the supplement group, will take capsules containing oil '2' which is an algal oil. Both oils are found in our diets. One group, the placebo group of the study, will take capsules containing oil '1 ' which is a mixture of corn and soy oils .
16102953|NCT02140866|Other|Hand Exercise|
16102954|NCT02140866|Other|Compensatory Intervention Program (CIP)|
16102955|NCT02140840|Drug|Trametinib|2 mg of Trametinib daily by mouth in 28 day cycles
16102956|NCT02140827|Other|IMP interactive education|The detail and FAQ (Frequently Asked Questions) of bowel preparation instructions is delivered by Wechat.
16102957|NCT02140814|Dietary Supplement|Niacinamide|
16102958|NCT02140801|Drug|Ticagrelor|Plain, round, yellow, filmcoated tablet, 90 mg
16102959|NCT02140801|Drug|Clopidogrel|Orange brown capsule, containing one 75 mg clopidogrel tablet (cut into 2 halves)
16102960|NCT02140788|Drug|Metformin|
16102961|NCT02140788|Drug|Fish Oil|
16102962|NCT02140775|Behavioral|Behavioral Activation Counseling|Behavioral Activation counseling is a manualized intervention adapted from a behavioral activation treatment for depression (BAT-D) and provides a basic foundation for behavior change. The individual sessions last one hour and are scheduled every two weeks. The counseling offers a brief, structured approach to identifying and scheduling activities in life areas to reduce avoidant behavior and increase activity level with the goal of achieving employment or enroll in training.
16103016|NCT02140320|Drug|RV1729 single dose|Safety and tolerability of single dose
16102963|NCT02140762|Biological|MenABCWY|Subjects received one dose of 0.5 mL MenABCWY vaccine (intramuscular (IM) injection) at day 1 and a second dose after 2 months.
16102964|NCT02140762|Other|Placebo|0.5 mL saline solution (IM)
16102965|NCT02140762|Biological|MenACWY|Subjects received one dose of 0.5 mL placebo (IM) at day 1 and one dose of 0.5 mL MenACWY vaccine (IM) after 2 months.
16102966|NCT02140749|Dietary Supplement|sc-FOS 2g/day|Chewing tablets containing Short-chain fructooligosaccharides 2g/day
16102967|NCT02140749|Dietary Supplement|sc-FOS 4g/day|Chewing tablets containing short-chain Fructooligosaccharides 4g/day
16102968|NCT02140749|Dietary Supplement|sc-FOS 8g/day|Chewing tablets containing short-chain Fructooligosaccharides 8g/day
16102969|NCT02140749|Dietary Supplement|Placebo|Chewing tablets without short-chain Fructooligosaccharides
16102970|NCT02140736|Drug|Epoetin biosimilar|
16102971|NCT02140723|Radiation|preoperative short course radiation|
16102972|NCT02140710|Procedure|Osteopathic treatment|visceral osteopathic treatment algorithm: Global listening and local listening on the abdomen Release lower ribs and thoracic diaphragm Pylorusrelaxation Release of the Duodenum and the C-Loop Small intestine diagnosis- Lifting the gut and bringing it to a stillpoint Root of mesentery diagnosis (and manipulation) Mobilisation of the ileocoecalic valve Mobilisation of colon ascendens, transversum, descendens Root of sigmoid diagnosis and manipulation
16102973|NCT02140697|Dietary Supplement|Hippophae rhamnoides L. Leaf Extract (3g/day)|Hippophae rhamnoides L. Leaf extract (3g/day), parallel design
16102974|NCT02140697|Dietary Supplement|Placebo (3g/day)|Placebo (3g/day), parallel design
16102975|NCT02140684|Device|eNO monitoring|Patient undergoing review with eNO monitored using either NIOX MINO® and NIOX Flex®
16102976|NCT02140658|Behavioral|multiple health education interventions|
16102977|NCT02140658|Behavioral|conventional health education|
16102978|NCT02140645|Drug|linagliptin|non-randomized
16102979|NCT02140632|Procedure|Local methylprednisolone acetate and lidnocaine injection|
16102980|NCT02140632|Device|wrist splinting|
16102981|NCT02140619|Behavioral|multiple health education interventions|
16102982|NCT02140606|Drug|Cafusertib Hydrochloride|Drug: Cafusertib Hydrochloride (d1 and 15) Cafusertib (d1 and 15 - one hour iv.v) Drug: Cytarabine Cytarabine 2 x 20 mg/d s.c. d1-15.
16102983|NCT02140593|Drug|Group STANDARD: Rocuronium 0.6 mg/kg followed by bolus rocuronium according to standard treatment combined with saline infusion (placebo).|
16102984|NCT02140593|Drug|Group DEEP: Rocuronium 0.6 mg/kg followed by rocuronium infusion with target level PTC 0-1 combined with bolus saline (placebo) mimicking standard treatment.|
16102985|NCT02140580|Device|Minimally invasive surfactant therapy|Active Comparator
16102986|NCT02140580|Other|Continuation on CPAP|Sham Comparator
16102987|NCT02140554|Genetic|bb1111|bb1111 is administered by IV infusion following myeloablative conditioning with busulfan.
16102988|NCT02140528|Biological|Mesenchymal stem cell injection|Injection of adipose derived mesenchymal stem cell in the site of tibia fracture .
16102989|NCT02140528|Biological|Placebo|
16102990|NCT02140515|Drug|Lutropin alfa|Administration of Gonal-F or recombinant Follicle Stimulating Hormone (rFSH)
16102991|NCT02140515|Drug|Follitropin alfa and Lutropin alfa|Administration of (rFSH) and (rLH)
16102992|NCT02140489|Drug|amosartan|
16102993|NCT02140489|Drug|rosuvastatin|
16102994|NCT02140489|Drug|amosartan and rosuvastatin|
16102995|NCT02140476|Device|Bipolar vessel sealing and cutting device|This device will be used in half of the patients with thyroid goiter and half of the patients with papillary thyroid cancer.
16102996|NCT02140476|Procedure|Conventional thyroidectomy|Tie and suture technique. This device will be used in half of the patients with thyroid goiter and half of the patients with papillary thyroid cancer.
16102997|NCT02140450|Drug|Timolol|2 drops of timolol, 10 minutes apart, 1-2 hours before intravitreal injection
16102998|NCT02140450|Drug|Brimonidine|Brimonidine eyedrop, 2 drops 5 minutes apart, 1-2 hours before intravitreal injection
16102999|NCT02140450|Drug|Acetazolamide|Acetazolamide tablet, 2 tabs, 2 hours before intravitreal injection
16103000|NCT02140450|Drug|Mannitol|Intravenous mannitol, 1.5 gram/kg, 1 hour before intravitreal injection
16103001|NCT02140450|Drug|Placebo|Artificial tears, 2 drops, 1-2 hours before intravitreal injection
16103002|NCT02140437|Drug|Fulvestrant|Adding fulvestrant to the standard endocrine therapy, anastrozole
16103003|NCT02140437|Drug|Anastrozole|standard endocrine therapy
16103004|NCT02140411|Drug|Ranibizumab Intravitreal injections|Ranibizumab intravitreal injections 3 months 1 per month and after PRN treatment.
16103005|NCT02140398|Procedure|Endometrial Currettage|Only Laparoscopic ovarian drilling without endometrial currettage will be performed
16103006|NCT02140385|Procedure|Abdominoplasty-Scarpa's fascia preservation|Thicker abdominal flaps will be preserved during the surgery.
16103007|NCT02140385|Procedure|Abdominoplasty-Scarpa's fascia ablation|Thinner abdominal flaps will be preserved during surgery.
16103008|NCT02140385|Device|Lymphoscintigraphy|Post-operative lymphatic imaging will be conducted using a common radiographic medium
16103009|NCT02140385|Device|3D Imaging|Post-operative 3-dimensional photography will take place at a regularly scheduled clinic appointment.
16103010|NCT02140385|Device|Abdominal ultrasound|Post-operative abdominal ultrasound will be used to determine the presence of fluid collections (seromas).
16103011|NCT02140372|Drug|Colchicine|Colchicine 1.2 mg followed by 0.6 mg one hour later
16103012|NCT02140359|Behavioral|Motivational Network Interview|Residents of a housing first permanent supporting housing program will be randomly assigned to this arm after screening and baseline assessments. They will meet roughly every two weeks with a case manager and answer questions about their social network, will be shown visual feedback about their networks, and will participate in a motivational interview conducted by the case managers. The questions and visualizations will be facilitated by an electronic tool for presenting screens with questions, capturing responses, processing and visualizing social network data.
16103013|NCT02140346|Drug|RV1729 28 day repeat dose|Safety and tolerability of repeat doses
16103014|NCT02140346|Drug|RV1729 matching placebo 28 day repeat dose|Safety and tolerability of repeat doses
16103015|NCT02140333|Drug|Erlotinib|100mg vs. 150mg
16103017|NCT02140320|Drug|RV1729 matching placebo single dose|Safety and tolerability of single dose
16103018|NCT02140320|Drug|RV1729 14 day repeat dose|Safety and tolerability of repeat doses
16103019|NCT02140320|Drug|RV1729 matching placebo 14 day repeat dose|Safety and tolerability of repeat doses
16103020|NCT02140320|Drug|RV1729 28 day repeat dose|Safety and tolerability of repeat doses
16103021|NCT02140320|Drug|RV1729 matching placebo 28 day repeat dose|Safety and tolerability of repeat doses
16103022|NCT02140307|Behavioral|Relaxation Response-based Mental Health Promotion (RR-MHP)|"The Open and Calm intervention is based on a standardized 9-week program. Week 1 uses a simple mantra-based meditation. Week 2 and 5 uses focus on the body. Week 3 and 6 uses focus on thoughts and emotions. Week 4 and 7 uses focus on social relationships. Weeks 8 and 9 were entitled The focus you feel like, where participants chose their own focus (e.g. two weeks of bodily focus if that was most relevant for a person, while another might chose 1 week focusing on emotions and another focusing on a social relationship)."
16103023|NCT02140294|Dietary Supplement|Polymeric nutritional supplements|
16103024|NCT02140294|Dietary Supplement|Standard Nutrional Treatment|
16103025|NCT02140281|Drug|Treatment A (cefadroxil alone)|A single 500 mg oral dose of cefadroxil will be given on the morning of Day 1
16103026|NCT02140281|Drug|Treatment B - AZD1722 followed by cefadroxil|15mg oral dose of AZD1722 will be given twice daily from Day 1 to Day 4 followed on the morning of Day 5 by a single dose of 15 mg AZD1722 taken together with a single 500mg dose of cefadroxil
16103027|NCT02140268|Drug|Midazolam|Volunteers will receive a single dose of Midazolam 7.5 mg on Day 1
16103028|NCT02140268|Drug|AZD1722|Volunteers will receive twice daily, oral doses of AZD1722 15 mg on Days 2-14
16103029|NCT02140268|Drug|AZD1722 and Midazolam|On Day 15 volunteers will receive AZD1722 15 mg and Midazolam 7.5 mg at the same time in the morning. In the evening on Day 15 AZD1722 15 mg will be administered alone.
16103030|NCT02140255|Drug|Nucleoside Reverse Transcriptase Inhibitors (NRTIs)|Chosen by the site investigator and dosed according to World Health Organization (WHO) or individual country or local standard guidelines.
16103031|NCT02140255|Drug|Nevirapine (NVP)|Administered orally. Dosed according to study step/participant's age/participant's weight.
16103032|NCT02140255|Drug|Lopinavir/Ritonavir (LPV/r)|Administered orally. Dosed according to study step and participant's age.
16103033|NCT02140255|Drug|Raltegravir (RAL)|Administered orally. Dosed according to study step and participant's age.
16103034|NCT02140255|Drug|VRC01|40 mg/kg administered subcutaneously
16103035|NCT02140242|Drug|study part 1 - dose daunorubicin|standard induction dose of daunorubicin 60 mg/m2 on days 3-5
16103036|NCT02140242|Procedure|induction cycles|single induction cycle versus double induction cycles (only patients with good response after first induction) Allocation is randomized for cytogenetic risk.
16103037|NCT02140229|Device|US power doppler|Clinical evaluation according to DAS28 and US every 3 months. US examination is realized in B and Doppler power mode for each studied joint: Ankles, shoulders, elbows, wrists, MCP 1 to 5, PIP 1 to 5, knees and MTP 1 to 5.
16103038|NCT02140229|Other|Usual care|Clinical evaluation and follow-up according to the practice of the referring rheumatologist every 3 months
16103039|NCT02140229|Other|ACR/EULAR criteria|Evaluation based on clinical evaluation according to DAS28 and ACR/EULAR remission criteria every 3 months.
16103040|NCT02140216|Biological|No blood transfusion|No blood transfusion
16103041|NCT02140216|Biological|Day 0 blood transfusion|Patients undergoing elective spine surgery receiving intra- or immediate-postoperative red cell blood transfusion.
16103042|NCT02140216|Biological|Day 1 or 2 blood transfusion|Patients undergoing elective spine surgery receiving first red cell blood transfusion on day 1 or 2 after surgery.
16103043|NCT02140203|Other|Yoga Training|one-year experimental training (three times per week and one hour per session)
16103044|NCT02140164|Drug|Minocycline|Oral dose of 100 mg (or appropriate weight-adjusted pediatric dose) of minocycline twice daily for 12 months.
16103045|NCT02140151|Drug|Ranibizumab 0.5mg|
16103046|NCT02140138|Biological|CV9104|
16103047|NCT02140138|Device|needle free injection device (Tropis®)|
16103048|NCT02140125|Drug|ASP2408|subcutaneous administration
16103049|NCT02140125|Drug|Placebo|subcutaneous administration
16103050|NCT02140112|Biological|Trichuris suis ova|
16103051|NCT02140112|Other|Placebo|
16103052|NCT02140099|Behavioral|Healthy Relationships Plus Program (HRPP)|The Healthy Relationships Plus Program (HRPP) is an out-of-school time program that is facilitated by a teacher or other youth leader. HRPP sessions use interactive teaching strategies to discuss healthy relationships, dating violence, personal values/boundaries, communication skills, emotional health and well-being, and helping friends.
16103053|NCT02140099|Behavioral|Control Condition (Classroom Activities)|
16103054|NCT02140086|Behavioral|Buteyko based Remedial Breathing Therapy|Buteyko based remedial Breathing Therapy after Dr. Buteyko
16103055|NCT02140073|Drug|omeprazole+domperidone SR|omeprazole 20mg+domperidone SR 30mg, 2 capsules in the morning
16103056|NCT02140073|Drug|omeprazole|40mg in the morning
16103057|NCT02140060|Drug|Dose Level A / Brinzolamide 1% ophthalmic suspension|Fixed combination
16103058|NCT02140060|Drug|Dose Level B / Brinzolamide 1% ophthalmic suspension|Fixed combination
16103059|NCT02140060|Drug|Dose Level C / Brinzolamide 1% ophthalmic suspension|Fixed combination
16103060|NCT02140060|Drug|Brinzolamide 1% ophthalmic suspension AZOPT®|
16103061|NCT02140060|Drug|Travoprost 0.004% ophthalmic solution TRAVATAN Z®|
16103062|NCT02140060|Drug|Travoprost solution vehicle|Inactive ingredients used for masking purposes
16103063|NCT02140060|Drug|Brinzolamide suspension vehicle|Inactive ingredients used for masking purposes
16103064|NCT02140047|Biological|Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-Low + DPT-IPV|0.25mL, subcutaneous injection
16103065|NCT02140047|Biological|Haemophilus b conjugate vaccine diphteria CRM197 protein conjugate)-High + DPT-IPV|0.5mL, subcutaneous injection
16103066|NCT02140047|Biological|Haemophilus influenza type b conjugate vaccine + DPT-IPV|0.5mL, subcutaneous injection
16103067|NCT02140034|Procedure|Extensive Peritoneal Lavage|
16103068|NCT02140021|Procedure|Biospecimen Collection|Undergo anal, cervical, vaginal, and oral sample collection
16103070|NCT02140008|Device|Insertion of I-gel|After induction of general anesthesia, I-gel will be inserted according to randomly allocated group.
16103071|NCT02140008|Device|Insertion of air-Q|After induction of general anesthesia, air-Q was inserted according to randomly allocated group.
16103072|NCT02139995|Behavioral|RBC transfusion based on different protocols|transfusion trigger for experimental group is the WCTS-CP；for active comparator is the physician's experience
16103073|NCT02139982|Procedure|specific nerve block|specific nerve blocks of the musculocutaneous, radial, ulnar, or median nerves at axillary region
16103074|NCT02139982|Drug|ropivacaine|Different concentration of ropivacaine
16103075|NCT02139969|Device|GreenLight XPS Laser System|
16103076|NCT02139956|Device|ultrasonography|open
16103077|NCT02139943|Drug|Canagliflozin 100 mg|Canagliflozin capsule of 100 mg dose will be taken orally, before the first meal of the day.
16103078|NCT02139943|Drug|Canagliflozin 300 mg|Canagliflozin capsule of 300 mg dose will be taken orally, before the first meal of the day.
16103079|NCT02139943|Drug|Placebo|Matching placebo capsule will be taken orally, before the first meal of the day.
16103080|NCT02139930|Behavioral|Normal Nicotine Control Group|Participants will smoke experimental cigarettes for a period of 20-weeks.
16103081|NCT02139930|Behavioral|Immediate Nicotine Reduction Group|Participants will smoke experimental cigarettes for a period of 20-weeks.
16103082|NCT02139930|Behavioral|Gradual Nicotine Reduction Group|Participants will smoke experimental cigarettes for a period of 20-weeks.
16103083|NCT02139917|Behavioral|Transitional community based palliative care|"transitional palliative care include:-
~telephone follow up for early identification of signs and symptoms
~relief of signs and symptoms encountered
~home visit with spiritual support"
16103084|NCT02139904|Drug|Vinorelbine|Vinorelbine was first licensed in the UK for Non-Small Cell Lung Cancer (NSCLC) and advanced breast cancer in 1997. Vinorelbine (Navelbine®) is a semi-synthetic, third generation, vinca alkaloid. The cytotoxic effect of vinorelbine is through the disruption of mitotic spindle formation, blocking mitosis at the G2-M stage resulting in cell death.
16103085|NCT02139904|Other|Active Symptom Control|
16103086|NCT02139891|Device|Cardiac Resynchronization Therapy with MultiPoint Pacing|
16103087|NCT02139878|Other|Wild blueberry juice|
16103088|NCT02139878|Other|Placebo wild blueberry juice|
16103089|NCT02139865|Behavioral|30% 1RM|Participant exercises using a protocol tailored at 30% of their 1RM
16103090|NCT02139865|Behavioral|80% 1RM|Participant exercises using a protocol tailored at 80% of their 1RM
16103091|NCT02139852|Dietary Supplement|Capsaicin|
16103092|NCT02139839|Other|Lactobacillus capsules|L. rhamnosus GR-1 and L. reuteri RC-14 capsules manufactured by Chr. Hansen
16103093|NCT02139839|Drug|Placebo gelatin pill|Placebo Comparator capsules, identical in appearance to the active product; 98% Gelatin with no L. rhamnosus GR-1 and L. reuteri RC- 14.
16103094|NCT02139826|Drug|IX-01|
16103095|NCT02139813|Procedure|Laparoscopic Mini-gastric bypass|"The laparoscopic Omega Loop Bypass will consist of:
~a long gastric tube, stapled approximately 1.5 cm from the left of the lesser curvature of the antrum to the angle of His
~a narrow gastric tube will be calibrated to be approximately 1.5 cm wide
~an Omega loop of 200 cm
~a unique gastro-jejunal anatomosis of 200cm from the ligament of Treitz, using a linear stapler"
16103096|NCT02139813|Procedure|Procedure of reference in bariatric surgery|"The laparoscopic Roux-en-Y Gastric Bypass will consist of:
~a small gastric pouch (about 30cc)
~an antecolic alimentary limb
~a gastro-jejunal anastomosis using a linear stapler
~a 150cm long alimentary limb
~a 50cm biliary limb
~a latero-lateral jejuno-jejunal anastomosis
~closure of the mesenteric defects"
16103097|NCT02139800|Procedure|Sustained Inflation|The first sustained inflation will use inflation pressure of 20 cm H20 for 15 seconds
16103098|NCT02139800|Procedure|Standard of Care|Newborn Resuscitation Program (NRP) Guidelines using a standard PEEP/CPAP of 5-7 cm H2O as compared to the Sustained Inflation intervention
16103099|NCT02139787|Other|Radio Story|
16103100|NCT02139787|Other|Control -listened to a brochure|
16103101|NCT02139774|Behavioral|Walk with Ease|A six week walking program by the Arthritis Foundation
16103102|NCT02139761|Drug|l-tetrahydropalmatine (l-THP)|Subjects will be dosed 30 mg BID (2 capsules total a day, total of 60mg/day), matching placebo or l-THP) (total 60 mg daily). The half-life of l-THP is about 10 hours, so subjects will reach steady state in about 2-3 days. The l-THP will be prepared at the University of Maryland School of Pharmacy to Chemistry under Good Manufacturing Practice (GMP) and standards. The identical placebo and active capsules will be manufactured and sent to the Maryland Psychiatric Research Center Pharmacy, where they will be stored, randomized and dispensed. Medication will be transported by the study staff to the participant once dispensing occurs.
16103103|NCT02139761|Drug|Placebo|Subjects will be dosed 30 mg BID (2 capsules total a day, total of 60mg/day), matching placebo or l-THP) (total 60 mg daily). The half-life of l-THP is about 10 hours, so subjects will reach steady state in about 2-3 days. The l-THP will be prepared at the University of Maryland School of Pharmacy to Chemistry under Good Manufacturing Practice (GMP) and standards. The identical placebo and active capsules will be manufactured and sent to the Maryland Psychiatric Research Center Pharmacy, where they will be stored, randomized and dispensed. Medication will be transported by the study staff to the participant once dispensing occurs.
16103104|NCT02139748|Procedure|Dental Implant & ADM|A dental implant will be placed and the buccal soft tissue will be grafted using an acellular dermal matrix allograft.
16103105|NCT02139748|Procedure|Dental Implant & ADM & bone xenograft|A dental implant will be placed along with a buccal acellular dermal matrix allograft which will cover a bone xenograft.
16103106|NCT02139735|Other|Ultrasound|3 MHz ultrasound in continuous mode with an intensity of 1.0 W / cm ² was applied for 3 minutes in the TMJ and masseter muscles bilaterally
16103107|NCT02139735|Other|Ultrasound associated with stretching|"3 MHz ultrasound in continuous mode with an intensity of 1.0 W / cm ² was applied for 3 minutes in the TMJ and masseter muscles, bilaterally.
~Active stretching of the masseter muscles with mouth opening and closed lips"
16103108|NCT02139735|Other|Placebo|Turned off ultrasound application on area of TMJ and masseter muscle, bilaterally.
16103197|NCT02139059|Procedure|initial urinary drainage|initial urinary drainage is done using nephrostomy or double J stent to stabilize renal functions. this is followed several days later by definitive ureteroscopy.
16103109|NCT02139722|Behavioral|Video Doctor, PA + PPN|The intervention consists of a Video Doctor and Provider Alert. For the Video Doctor, we will develop a series of 30-60 seconds video clips, a branching algorithm, and a mobile application linking the baseline survey to the clips. The Provider Alert is a point-of-care reminder printout generated by the mobile application to facilitate patient-provider communication. The intervention integrates guidelines, literature, guidance from the Systems Model, our prior work, and input from patients and providers.
16103110|NCT02139709|Dietary Supplement|Ganglioside|
16103111|NCT02139709|Dietary Supplement|Placebo|
16103112|NCT02139696|Radiation|PET and MRI|Patients will be imaged using PET and MRI at baseline, and twice during treatment
16103113|NCT02139683|Device|HIFU treatment|HIFU treatment in patients with fibroadenoma
16103114|NCT02139657|Biological|RIG-C|
16103115|NCT02139644|Drug|FS MDPI|"FS MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) and salmeterol xinafoate (Sx) dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened.
~During the treatment period, participants were randomized to either 100/12.5 mcg Fp/Sx or 50/12.5 mcg Fp/Sx in the morning and evening for a total daily dose of 200/25 mcg or 100/25 mcg Fp/Sx.
~Participants were instructed to rinse their mouth and expectorate (not swallow) after study drug administration."
16103116|NCT02139644|Drug|Fp MDPI|"Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened.
~During the treatment period, participants were randomized to either 100 mcg or 50 mcg of Fp one inhalation twice a day for a total daily dose of 200 mcg or 100 mcg.
~Participants were instructed to rinse their mouth and expectorate (not swallow) after study drug administration."
16103117|NCT02139644|Drug|Placebo MDPI|Placebo administered via a multidose dry powder inhaler (MDPI) one puff in the morning and one puff in the evening for 12 weeks.
16103118|NCT02139644|Drug|albuterol/salbutamol|A short-acting β2-adrenergic agonists (SABA), albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI), was provided to be used as needed for the relief of asthma symptoms during both the run-in and treatment periods (to replace the subject's current rescue medication).
16103119|NCT02139644|Drug|Beclomethasone dipropionate|QVAR (beclomethasone dipropionate) 40 mcg inhalation aerosol is a pressurized MDI that contains a Food and Drug Administration (FDA)-approved formulation of beclomethasone dipropionate. Patients took 1 puff twice a day from open-label QVAR 40 mcg hydrofluoroalkane (specifically, HFA-134a) metered-dose inhaler (MDI) for the duration of the Run-in Period (14-21 days) and prior to randomization. A clinically equivalent dose of inhaled corticosteroid (ICS) was substituted in countries where QVAR 40 mcg was not available.
16103120|NCT02139631|Other|Noninvasive ventilation|Assess the hemodynamic repercussions of the positive end expiratory pressure applied noninvasively
16103121|NCT02139618|Drug|Methyl Aminolevulinate (MAL)|
16103122|NCT02139618|Drug|Placebo|
16103123|NCT02139605|Procedure|D3 Lymphadenectomy|D3 Lymphadenectomy involves surgical removal of lymph nodes from echelon or compartments 1 to 3 in gastric cancer patients
16103124|NCT02139592|Drug|Brentuximab vedotin (recombinant)|Brentuximab vedotin (recombinant) for IV infusion
16103125|NCT02139579|Drug|Bevacizumab|7.5 mg/kg every 3 weeks
16103126|NCT02139566|Behavioral|Video consent (high-tech)|Consent provided by an animated video with captions
16103127|NCT02139566|Behavioral|Video consent (low-tech)|This consent is a video production of the informed consent information, taped using a staff member with basic video equipment.
16103128|NCT02139566|Behavioral|FAQ format consent|"This consent modality will present the basic information from the informed consent in an interactive, frequently asked questions format. Upon clicking each question, the participant will be shown a short text response to that question."
16103129|NCT02139566|Behavioral|Standard consent|The standard consent form will present the full informed consent document in a scrolling text window within the browser window. Participants will be asked to review the document online.
16103130|NCT02139566|Behavioral|PDF informed consent document|A PDF of the full consent document will be available for download, through hyperlink on the consent page. This is provided for video (low-tech), video (high-tech), FAQ format, and standard informed consent.
16103131|NCT02139553|Procedure|Rhythmic rehabilitation|Stroke patients have 12 rehabilitation sessions on a planar rehabilitation robot, Reaplan, focussed on rhythmic arm movements.
16103132|NCT02139540|Drug|Nitrous Oxide|"Patients will receive either up to 50% nitrous oxide/50% oxygen for 1 hour or placebo (50% nitrogen [inert]/50% oxygen) in two separate sessions. Both sessions will be 1 week apart."
16103133|NCT02139540|Drug|Placebo|50% nitrogen [inert]/50% oxygen - otherwise completely identical administration and setup
16103134|NCT02139527|Device|Total Disc Replacement|
16103135|NCT02139514|Behavioral|Virtual Reality Social Cognition Training|Social skills training via virtual reality with trained therapist.
16103136|NCT02139501|Drug|Recombinant Human Thrombopoietin (rhTPO)|rhTPO was given intravenously at a dose of300Units/kg ,daily for 14 consecutive days;at a dose of 300Units/kg ,one times every other day for 7 times; or at a dose of 300Units/kg ,daily for 7 consecutive days
16103137|NCT02139488|Other|Fiducial markers|
16103138|NCT02139488|Other|Fiducial markers, Pet and MRI|Insertion of Fiducial markers in esophageal wall.
16103139|NCT02139475|Procedure|Colonoscopy|
16103140|NCT02139462|Other|Standard FBT training|Therapists will receive standard training in Family Based Treatment (FBT)
16103141|NCT02139462|Other|Novel FBT training|Therapists will receive a novel training in Family Based Treatment (FBT)
16103142|NCT02139449|Procedure|ICD/CRT|cardiac resynchronized therapy (CRT), implantable cardioverter defibrillator (ICD) implantation
16103143|NCT02139436|Other|FES-row-training|
16103144|NCT02139436|Other|Arms-only-row training|
16103145|NCT02139423|Other|CMV PCR|
16103146|NCT02139410|Procedure|IGF-1 serum value|Evaluation of IGF-1 serum value at baseline, 24 and 48 months
16103147|NCT02139397|Drug|DFMO|
16103148|NCT02139397|Drug|Bortezomib|
16103149|NCT02139371|Other|Injection of 64Cu-DOTA-AE105|One injection of 64Cu-DOTA-AE105 (app. 200 Mbq) followed by Positron Emission Tomography Scan 1, 3 and 24 hours post injection
16103150|NCT02139358|Drug|Gemcitabine|The Phase I trial will start at the recommended phase II dose (RP2D) for gemcitabine but will have a de-escalation dose levels in the event that an unacceptable toxicity requires dose reduction. Dose level 0 = gemcitabine (1200 mg/m2) IV D1,8 q21 days; Dose level -1 = gemcitabine (1000 mg/m^2) IV D1,8 q21 days; Dose level -2 = gemcitabine (850 mg/m^2) IV D1,8 q21 days. The RP2D will be the dose level where 0-1 dose limiting toxicities (DLTs) in six patients occur.
16103151|NCT02139358|Drug|Trastuzumab|Trastuzumab will be given using an 8 mg/kg loading dose on cycle one, day one (C1D1), followed by 6 mg/kg IV on subsequent cycles every (q) 21 days.
16103152|NCT02139358|Drug|Pertuzumab|Pertuzumab will be given using an 840 mg IV loading dose on C1D1, followed by 420 mg IV on subsequent cycles q 21 days.
16103153|NCT02139345|Device|TC-A PS Total Knee Replacement System|Subject will be implanted with the TC-A PS Total Knee Replacement System
16103154|NCT02139345|Device|TC-PLUS Solution PS Total Knee Replacement System|Subject will be implanted with the TC-PLUS Solution PS Total Knee Replacement System
16103155|NCT02139332|Behavioral|PFR Group|"The intervention consists of delivering the Promoting First Relationship (PFR) program. PFR comprises 10 sessions and lasts approximately 12 weeks. Each session begins with a brief discussion and education on the target topic for that week . Then 20 minutes is spent on video recording a structured interaction between the caregiver and child or viewing the previous session's recording and engaging in reflective discussion about successful caregiving strategies and child's response to caregiver behavior (alternating weeks). Trained PFR specialists who are community members use the 5 consultation strategies, labeled Joining, Positive Feedback, Instructive Feedback, Reflective Questions and Comments, and Instruction with Handouts."
16103156|NCT02139332|Behavioral|Resource & Referral Group|The Resource & Referral program consists of 1) an initial needs assessment to determine if the enrolled family has any unmet needs (housing, financial, health, mental health, etc…), 2) a tailored resource and referral packet will be mailed to the participant with the most important referrals marked, 3) a follow-up call will be made two weeks after mailing the packet to verify that the participant has received it, and 4) a second follow-up call will be made three months after the initial session, to assess types of services actually received, barriers to receiving services, and reassessing resources needed and providing additional referrals if needed.
16103157|NCT02139319|Drug|Botulinum toxin|
16103158|NCT02139319|Drug|Placebo|
16103159|NCT02139306|Drug|Ataluren (PTC124®)|Oral Ataluren TID
16103160|NCT02139306|Drug|Placebo|Oral Placebo TID
16103161|NCT02139293|Device|PrimeStim|Intermittent auricular vagus nerve stimulation at different ear points
16103162|NCT02139280|Drug|Cyclophosphamide|Mechanism of action: Cyclophosphamide is a pro drug that requires activation. Following hepatic and cellular activation, phosphoramide mustard and acrolein are formed. Phosphoramide mustard is the alkylating agent that demonstrates cytotoxic effects. Acrolein binds to proteins but does not contribute to the anti-tumor effects.
16103163|NCT02139267|Biological|GX-188E|DNA vaccine administered via IM route using TDS-IM electroporation device
16103164|NCT02139241|Drug|Ramosetron|0.3 mg IV as bolus before induction of general anesthesia
16103165|NCT02139241|Drug|Normal saline|2 ml normal saline as bolus before induction of general anesthesia
16103166|NCT02139228|Biological|Hib-CRM197|No vaccine administered in V37_07E2 study
16103167|NCT02139228|Biological|Hib-TT|No vaccine administered in V37_07E2 study
16103168|NCT02139202|Behavioral|Social Influence|
16103169|NCT02139202|Behavioral|Electronic Pill Bottles|
16103170|NCT02139202|Behavioral|Financial Incentives|
16103171|NCT02139189|Device|P-ECM Implant|P-ECM Implant into damaged ischemic and/or infarcted myocardium
16103172|NCT02139176|Behavioral|contract referral|A female partner signs a contract saying it is permissible for a community worker to trace a male sex partner in the community.
16103173|NCT02139176|Behavioral|patient referral|A patient agrees to recruit their partner using the invitation.
16103174|NCT02139163|Other|Cohort Study|
16103175|NCT02139150|Radiation|[18F] FLT|
16103176|NCT02139150|Device|PET/CT scans|
16103177|NCT02139137|Other|Computerized Cognitive Training - active|Cognitive training using working memory span task
16103178|NCT02139137|Other|Computerized cognitive training - sham|Sham training condition
16103179|NCT02139124|Drug|Placebo|Oral placebo capsule
16103180|NCT02139124|Drug|PRC-063 25 mg|Oral 25 mg capsule - active
16103181|NCT02139124|Drug|PRC-063 45 mg|Oral 45 mg capsule - active
16103182|NCT02139124|Drug|PRC-063 70 mg|Oral 70 mg capsule - active
16103183|NCT02139124|Drug|PRC-063 100 mg|Oral 100 mg capsule - active
16103184|NCT02139111|Drug|Placebo|Oral placebo capsule
16103185|NCT02139111|Drug|PRC-063 25 mg|Oral 25 mg capsule - active
16103186|NCT02139111|Drug|PRC-063 45 mg|Oral 45 mg capsule - active
16103187|NCT02139111|Drug|PRC-063 70 mg|Oral 70 mg capsule - active
16103188|NCT02139111|Drug|PRC-063 85 mg|Oral 85 mg capsule - active
16103189|NCT02139098|Drug|Amitriptyline|50 mg capsule amitriptyline before going to bed on 8 out of 17 nights
16103190|NCT02139098|Drug|Zolpidem|5 mg capsule zolpidem before going to bed on 8 out of 17 nights
16103191|NCT02139098|Drug|Amitriptyline|50 mg capsule amitriptyline before going to bed on 13 out of 17 nights
16103192|NCT02139098|Drug|Placebo|Placebo
16103193|NCT02139085|Device|GSV Electrocoagulation|The energy source will be the Electrosurgical Generator (FX-Valley Lab; USA) and the GSV thermo ablation will be performed with 60 Watts per 10 seconds. The catheter and electrocoagulation device head will be pulled back in increments of 2 cm also to overlap the treatment sites.
16103194|NCT02139085|Device|GSV Radiofrequency|The second generation RF device (Closure FAST; Covidien, USA) will be used. The treatment component of the device is 7 cm in length and works with a segmental pullback protocol. Once the catheter is in position, activation of the generator delivers 20- seconds cycles of energy to the catheter tip, which heats the vein wall to 120 o C.
16103195|NCT02139072|Device|CoaguChek XS|CoaguChek XS will be used to measure INR in patients with APL
16103196|NCT02139072|Procedure|Standard Lab Draw|Patients on warfarin for any indication other than APL will measure INR by venous lab draw
16103338|NCT02137928|Drug|chemotherapy|Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months.
16103198|NCT02139059|Procedure|direct ureteroscopy|direct ureteroscopy is done without initial urinary drainage and before return to normal chemistry. this is followed follow-up of renal functions for several days before treatment of the contralateral side.
16103199|NCT02139046|Drug|Febuxostat IR|Febuxostat IR over-encapsulated tablets
16103200|NCT02139046|Drug|Febuxostat XR|Febuxostat XR over-encapsulated capsules
16103201|NCT02139046|Drug|Febuxostat placebo|Febuxostat placebo-matching capsules
16103202|NCT02139046|Drug|Colchicine|Colchicine tablets
16103203|NCT02139046|Drug|Naproxen|Naproxen tablets
16103204|NCT02139046|Drug|Lansoprazole|Lansoprazole capsules
16103205|NCT02139033|Drug|Retaine™|
16103206|NCT02139020|Other|Plasma samples|Plasma samples at baseline (and one whole blood sample) and at every radiological evaluations
16103207|NCT02139007|Drug|Alendronate|
16103208|NCT02138994|Device|Next Science Wound Gel|
16103209|NCT02138994|Drug|Triple Antibiotic Ointment Neosporin|"Subjects randomized to Neosporin will be required to complete 1 month of treatment comprising a screening/baseline, 2-week and 1-month visits. After 1 month the following may occur based on wound progression and/or the investigator's clinical judgment:
~Subject may continue the application of Neosporin until wound closure or
~Subject may cross over to the treatment group for 3 months"
16103210|NCT02138981|Procedure|Chemoembolization and Response-Dependent Resection|patients underwent transarterial chemoembolization (TACE) as initial treatments, and only patients who showed good response were subjected to surgical resection.
16103211|NCT02138981|Procedure|Immediate Resection|patients received immediate surgical resection.
16103212|NCT02138968|Other|Multidisciplinary intervention|Multidimensional intervention based on: good control of baseline diseases, review of medication adequacy, exercise program, nutritional assessment and control, social assessment and control.
16103213|NCT02138955|Drug|Liposomeal curcumin|
16103214|NCT02138942|Device|Learning Intravenous Resuscitator (LIR) system|The usual patient pathways and recommendations concerning vascular filling remain strictly unchanged in this study. The only thing that differs from usual care is the use of the LIR system to automatically optimize fluid resuscitation during general anesthesia, with continuous supervision by the anesthesiologist present during the entire period of use of the device.
16103215|NCT02138929|Drug|Everolimus|Induction and Dose Expansion Phase: 10 mg by mouth daily in a 28 day cycle.
16103216|NCT02138929|Drug|LDE 225|"Induction Phase Starting Dose: 400 mg by mouth daily in a 28 day cycle.
~Expansion Phase Starting Dose: Maximum tolerated dose from Induction Phase."
16103217|NCT02138916|Drug|Benralizumab Arm A|Benralizumab subcutaneously on study week 0 until study week 48 inclusive
16103218|NCT02138916|Drug|Benralizumab Arm B|Benralizumab subcutaneously on study week 0 until study week 48 inclusive
16103219|NCT02138916|Drug|Placebo|Placebo subcutaneously on study week 0 until study week 48 inclusive
16103220|NCT02138903|Other|trans thoracic echocardiography|
16103221|NCT02138890|Device|APS|Intra-articular Injection
16103222|NCT02138890|Device|Saline|Intra-articular injection
16103223|NCT02138877|Procedure|After coming stent after dismembered pyeloplasty|Dismembered pyeloplasty through lumbar incision. The patients who are randomized to the after coming stent arm, an after coming stent is inserted. Distal part of it is positioned in the mid ureter. The proximal end is passed through the renal parenchyma (usually the lower kidney calyx) to be exteriorized through stab wound and fixed to the skin. The size of external stent is 4-5 F.
16103224|NCT02138877|Procedure|Stentless dismembered pyeloplasty|Dismembered pyeloplasty through lumbar incision. No stents are inserted
16103225|NCT02138864|Radiation|18F-FP-(+)-DTBZ|no available
16103226|NCT02138851|Dietary Supplement|Ficus Carica (300g/day)|Ficus Carica (300g/day), parallel design
16103227|NCT02138851|Dietary Supplement|Placebo (300g/day)|Placebo (300g/day), parallel design
16103228|NCT02138838|Drug|Cinacalcet HCl|Capsules were opened and either sprinkled onto soft food (≥ 5 mg dose) or suspended into a sucrose syrup (≥ 2.5 mg dose) to create a liquid suspension for administration. Tablets were used for doses of 30 mg and higher in participants who could swallow tablets.
16103229|NCT02138838|Dietary Supplement|Standard of Care|Standard of care therapy included the use of vitamin D sterols, calcium supplementation, and phosphate binders.
16103230|NCT02138825|Drug|Riociguat (Adempas, BAY63-2521)|Active drug 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID/day as per individual dose titration. The starting dose will be 0.5 mg TID, and the dose will be adjusted every two weeks for ten weeks in 0.5 mg increments up to a maximum dose of 2.5 mg TID based on patient's systolic blood pressure and well-being.
16103231|NCT02138825|Drug|Placebo|Inactive dosed at 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg and 2.5 mg TID/day as per individual dose titration for 26 weeks
16103232|NCT02138812|Drug|BAY1161909|Given orally, with a starting dose of 0.75 mg twice daily from C1D1 onwards in a 2 days on/5 days off dosing schedule as single agent treatment in Cycle 1 (14 days), and from C2D8 onwards in a 2 days on/5 days off dosing schedule in 28-day cycles. For single-dose PK cohort: a single oral dose on C1D1
16103233|NCT02138812|Drug|Paclitaxel|75 mg/m^2 (initial dose escalation) or 90 mg/m^2 (second dose escalation), weekly intravenously (IV) infusion on D1, D8, and D15 of the 28-day cycles from C2D1
16103234|NCT02138799|Drug|enzalutamide|oral
16103235|NCT02138799|Drug|rifampin|oral
16103236|NCT02138786|Drug|selinexor|"60 mg dose twice weekly, on Days 1 and 3 of weeks 1-4 of each 4-week cycle; dose may be increased to 80 mg after Cycle 1 unless clinically contraindicated (Protocol V.5.0).
~60 mg dose twice weekly on Days 1 and 3 of weeks 1-3 of each 4-week cycle; dose may be increased to 80 mg at Cycle 3 Day 1 unless clinically contraindicated (Protocol V.4.0).
~60 mg/m² dose, based on BSA, twice weekly, on Days 1 and 3 of weeks 1-3 of each 4-week cycle (Protocol V. 3.0).
~60 mg/m² dose, based on BSA, twice weekly, on Days 1 and 3 of weeks 1-4 of each 4-week cycle (Protocol V. < 3.0)."
16103237|NCT02138773|Drug|Tamsulosin formulation-A|oral
16103238|NCT02138773|Drug|Tamsulosin formulation-B|oral
16103239|NCT02138760|Procedure|MRI UroNav fusion biopsy|
16103240|NCT02138747|Drug|Mirabegron|Oral
16103241|NCT02138747|Drug|Tolterodine ER|Oral
16103339|NCT02137915|Biological|Human Central Nervous System Stem Cells|
16103438|NCT02137213|Drug|Naloxone|Naloxone will be added to oral methadone preparation in methadone:naloxone ratio of 50:1
16103242|NCT02138734|Biological|BCG+N-803|"BCG and N-803 will be mixed together (with saline) and administered via intravesical instillation weekly for 6 consecutive weeks for induction. Phase IIb includes maintenance treatment consisting of BCG+N-803 for 3 consecutive weeks at 3, 6, 12, & 18 months.
~An additional 6 week re-induction of BCG+N-803 for patients with eligible disease at 3 months in phase IIb is included."
16103243|NCT02138734|Biological|BCG|"BCG will be administered via intravesical instillation weekly for 6 consecutive weeks for induction. Phase IIb includes maintenance treatment consisting of BCG for 3 consecutive weeks at 3, 6, 12, & 18 months.
~An additional 6 week re-induction of BCG for patients with eligible disease at 3 months in phase IIb is included."
16103244|NCT02138721|Procedure|Radical Prostatectomy (RP)|Radical Prostatectomy with extended Pelvic Lymph Node Dissection within 8 weeks after inclusion.
16103245|NCT02138708|Other|Pharmacological test of pulmonary endothelial|
16103246|NCT02138682|Drug|l-123 Ioflupane|5 millicuries of Ioflupane
16103247|NCT02138669|Device|Intacs|INTACS® prescription inserts are an ophthalmic medical device designed for the reduction or elimination of myopia and astigmatism in patients with keratoconus so that their functional vision may be restored and the need for a corneal transplant procedure can potentially be deferred.
16103248|NCT02138656|Other|Chiropractic|Chiropractic treatment delivered in accordance with clinical protocols developed and agreed with the participant clinicians
16103249|NCT02138656|Other|Best Standard Care|Counselling and advice delivered in accordance with the Map of Medicine care pathway for Infantile colic
16103250|NCT02138643|Procedure|Endoscopic surgery|These will be treated with Endoscopic surgery - Peroral endoscopic myotomy (POEM)
16103251|NCT02138643|Procedure|Laparoscopic surgery|These will be treated with Laparoscopic surgery - Laparoscopic Heller myotomy.
16103252|NCT02138630|Dietary Supplement|Capsaicin|
16103253|NCT02138630|Dietary Supplement|Placebo|Sugar capsule
16103254|NCT02138617|Drug|5-Fluorouracil|400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours, Day 1 and Day 15 .
16103255|NCT02138617|Drug|Leucovorin|200-400 mg/m2 IV over 2 hours, Day 1 and Day 15
16103256|NCT02138617|Drug|Irinotecan|IV infusion over 90 minutes, dosed at 180, 260 or 310 mg/m2 based on genotype.
16103257|NCT02138617|Drug|Bevacizumab|Bevacizumab (5 mg/kg IV infused as per institutional policy, IV, Day 1, 15)
16103258|NCT02138591|Procedure|Blood draw pre-operatively|Pre-Operative blood draw of approximately 32ml will check the following: Vitamin D (25-OHD), Calcium, Cathelicidin and Resistin levels in the blood.
16103259|NCT02138591|Procedure|Blood draw post-operative Day 1|Blood draw of approximately 32ml to check the following: Vitamin D (25-OHD), Calcium, Cathelicidin and Resistin levels in the blood.
16103260|NCT02138591|Procedure|Blood draw post-operative Day 2|Blood draw of approximately 32ml to check the following: Vitamin D (25-OHD), Calcium, Cathelicidin and Resistin levels in the blood.
16103261|NCT02138578|Radiation|SBRT|
16103262|NCT02138578|Radiation|RFA|
16103263|NCT02138565|Procedure|Gastric by-pass surgery|
16103264|NCT02138552|Drug|Octenidine dihydrochloride|Mouthrinsing - comparison of different dosages of Octenidine dihydrochloride over 4 days vs. Placebo
16103265|NCT02138552|Drug|Placebo|Mouthrinsing - comparison of different dosages of Octenidine dihydrochloride over 4 days vs. Placebo
16103266|NCT02138539|Other|Herbal depigmenting agent (Epionce)|A two product herbal pigmentation reducing regimen is applied twice a day to either the left or right side of the face for a duration of 4 months.
16103267|NCT02138539|Drug|Hydroquinone|Hydroquinone 4% is applied twice a day to either the left or right side of the face for a duration of 4 months.
16103268|NCT02138526|Drug|pazopanib|pazopanib 800mg OD without food
16103269|NCT02138526|Other|continental breakfast|pazopanib 600mg OD with food
16103270|NCT02138513|Behavioral|Mindfulness Based Cognitive Therapy|This MBCT protocol consists of 8 weekly sessions of 2,5 hours each and a silent day of 6 hours of meditation practice. Similar to group MBCT, in the online MBCT group, participants will be asked to practice at home for 45 minutes, 6 days a week. They will receive files with meditation and yoga exercises to support this.
16103271|NCT02138500|Drug|PF-06372865|Single, oral dose administration of 10 mg PF-06372865 using tablet formulation.
16103272|NCT02138500|Drug|PF-06372865|Single, oral dose administration of TBD dose PF-06372865 using tablet/extemprep formulation.
16103273|NCT02138500|Drug|PF-06372865|Single, oral dose administration of TBD dose PF-06372865 using tablet/extemprep formulation.
16103274|NCT02138487|Other|liberal postoperative activity|Women will be given specific instructions regarding postoperative activities and will not have any limitations regarding activity.
16103275|NCT02138487|Other|Restricted postoperative activity|Women in this group will be given instructions regarding postoperative activity and will need to abstain from heavy lifting, running, aerobics for 3 months.
16103276|NCT02138474|Other|Lacticum acidum homaccord|Homeopathic remedy, made using sucrose pillules
16103277|NCT02138474|Other|Placebo|Unmedicated sucrose pillules
16103278|NCT02138448|Behavioral|Interactive Preventive Health Record|The interactive preventive healthcare record (IPHR) is a patient-centered application that links patients to their clinician's record, explains information in lay language, displays tailored recommendations and educational resources, and makes preventive care actionable.
16103279|NCT02138435|Other|MRI exercise test|Measuring cardiac output with MRI during exercise on an ergometer bicycle.
16103280|NCT02138435|Other|Gas-exchange exercise test|Measuring cardiac output by gas-exchange, while during exercise on an ergometer bicycle.
16103281|NCT02138422|Biological|Xilonix|
16103282|NCT02138422|Biological|Placebo|
16103283|NCT02138409|Drug|Fentanyl Sublingual Spray (FSS)|Fentanyl sublingual spray (FSS) packaged to deliver 100 µg/spray, 200 µg/spray or 400 µg/spray
16103284|NCT02138409|Drug|Placebo Sublingual Spray (PSS)|Placebo sublingual spray (PSS) packaged to match FSS, but deliver no drug
16103285|NCT02138396|Drug|Fentanyl Sublingual Spray (FSS)|A single dose of fentanyl, 400 mcg per sublingual spray
16103286|NCT02138396|Drug|Fentanyl Citrate Injection (FCI)|A single dose of fentanyl citrate, 100 mcg per intramuscular injection
16103287|NCT02138396|Drug|Naltrexone|Naltrexone is provided as a 50 mg tablet before and after product dosing to minimize unacceptable adverse effects of fentanyl.
16103439|NCT02137213|Drug|Placebo|Normal saline will be added to oral methadone preparations as placebo.
16103288|NCT02138383|Drug|Enzalutamide|The starting dose of enzalutamide will be 80 mg (Level 1) daily, taken orally. The dose escalation schedule is a standard 3 + 3 design. In the first part of the study, different doses of enzalutamide will be tested. In the second part of the study, all patients will be started at the same dose of enzalutamide.
16103289|NCT02138383|Drug|Gemcitabine|The starting dose of gemcitabine will be 1000 mg/m^2 administered intravenously on days 1, 8 and 15 of each cycle.
16103290|NCT02138383|Drug|Nab-paclitaxel|The starting dose of nab-paclitaxel will be 125 mg/m^2 administered intravenously on days 1, 8 and 15 of each cycle.
16103291|NCT02138357|Drug|buprenorphine transdermal delivery system (BTDS)|
16103292|NCT02138357|Drug|Placebo for BTDS patch|A placebo patch will be manufactured to mimic the BTDS patch.
16103293|NCT02138331|Biological|MSC exosomes.|Exosomes: (Size) 40-100 nm, (markers) CD63, CD9, Alix, TSG 101, HSP 70 Microvesicles: (Size) 100-1000 nm, (markers) Annexin V, Flotillin-2, selectin, integrin, CD40 metalloproteinase
16103294|NCT02138318|Other|High definition (HD) endoscopy|
16103295|NCT02138318|Other|chromoendoscopy|
16103296|NCT02138305|Device|ComboMap XT Guidewire|Intracoronary pressure and flow measurements
16103297|NCT02138305|Procedure|'SPY' NIRF During CABG|FDA approved use of injection of indocyanine green for the purposes of performing pre and post coronary grafting graft patency and perfusion assessment with the SPY near infra red fluorescence system
16103298|NCT02138292|Drug|Trametinib (2mg)/Digoxin (.25mg)|"Trametinib (2mg) will be administered orally on a daily basis.
~Digoxin (0.25mg) will be administered orally on a daily basis.
~On a 8 week cycle, duration of treatment can last from 8 to 104 weeks."
16103299|NCT02138266|Device|Topcon Specular Microscope SP-1P|
16103300|NCT02138266|Device|Konan Specular Microscope CELLCHEK XL|
16103301|NCT02138253|Drug|IDN-6556|
16103302|NCT02138253|Drug|Placebo|Placebo control
16103303|NCT02138240|Behavioral|Social network intervention|The intervention combined a social network approach with strategies that address public housing residents' challenges related to the built environment to improve dietary habits. Given the frequent intake of sugar-sweetened beverages (SSB) in this population, the intervention focused on reducing added sugar intake through the reduced consumption of SSB.
16103304|NCT02138227|Behavioral|Assisted CEaD Condition|In the assisted condition, participants use the CEaD training materials supplemented with simulators to practice the communication skills. OPO requesters will be assisted by having the CEaD DVD supplemented through working the scenarios with live simulated patients who will be trained to act out the scenarios with the OPO requesters and provide feedback.
16103305|NCT02138227|Behavioral|Autonomous CEaD Condition|In the autonomous condition, participants view the CEaD training materials on a DVD along with a self-training guide.
16103306|NCT02138214|Procedure|Thyroidectomy|Undergo total thyroidectomy
16103307|NCT02138214|Procedure|entral lymph node dissection (CLND)|Undergo total thyroidectomy with ipsilateral prophylactic CND
16103308|NCT02138214|Other|Quality-of-life assessment|Voice evaluation, interviews, ancillary studies
16103309|NCT02138162|Drug|enzalutamide|oral
16103310|NCT02138136|Drug|Lubiprostone|12 or 24 mcg soft capsules for oral administration
16103311|NCT02138123|Procedure|IOL-shell technique|Phacoemulsification was performed with the same device and handpieces, using the same phaco chop technique as in the conventional procedure group. What was different was that before the emulsification of the last nuclear fragment, cohesive viscoelastic material was injected below the nuclear fragment and a foldable IOL was implanted into the well inflated capsular bag posterior to the nuclear fragment. The remaining last piece of nuclear fragment was then emulsified and removed within the capsular bag.
16103312|NCT02138123|Procedure|Conventional procedure|In this procedure, a IOL was not implanted until all the nuclear fragments were removed.
16103313|NCT02138110|Device|Neuro-Spinal Scaffold|Implantation of a Neuro-Spinal Scaffold into the epicenter of the post-irrigation contusion cavity during open spine surgery
16103314|NCT02138084|Drug|BMS-663068|BMS-663068
16103315|NCT02138084|Drug|Rifabutin|Rifabutin
16103316|NCT02138084|Drug|Ritonavir|Ritonavir
16103317|NCT02138058|Drug|Topiramate|
16103318|NCT02138058|Behavioral|Cognitive restructuring intervention|4 sessions of a manualized cognitive restructuring intervention for compulsive buying
16103319|NCT02138045|Drug|Placebo treatment|Treatment continues at highest tolereable dose (minimum 1.2 mg/day). Intervention time 26 weeks at target dose.
16103320|NCT02138045|Drug|Liraglutide treatment|Treatment continues at highest tolereable dose (minimum 1.2 mg/day). Intervention time 26 weeks at target dose.
16103321|NCT02138032|Behavioral|Gains Framed Message|
16103322|NCT02138032|Behavioral|Loss Framed Message|
16103323|NCT02138019|Procedure|Fibrin Glue assisted external eye surgery|
16103324|NCT02138019|Device|Fibrin glue|
16103325|NCT02138006|Drug|Intensive insulin treatment|Mealtime insulin (Actrapid) Basal insulin (Monotard)
16103326|NCT02138006|Drug|Standard insulin treatment|Insulin Mixtard
16103327|NCT02137993|Drug|A-prexa|A-prexa 5-20 mg for 6 weeks
16103328|NCT02137993|Drug|Zyprexa|Zyprexa 5-20 mg for 6 weeks
16103329|NCT02137967|Procedure|NaOCl pulpotomy|Use 2.5% NaOCl as pulpotomy medicament for primary molars
16103330|NCT02137967|Procedure|FC pulpotomy|Use 20% Formocresol as pulpotomy medicament for primary molars
16103331|NCT02137967|Drug|2.5% NaOCl|
16103332|NCT02137967|Drug|20% Formocresol|
16103333|NCT02137954|Drug|Lidocaine|
16103334|NCT02137954|Drug|Placebo|
16103335|NCT02137941|Behavioral|techniques to optimize potential (TOP)|The TOP consists of learning easy techniques in mental skills to improve cognitive-based problem-solving using respiration, relaxation, and visualization.
16103336|NCT02137941|Behavioral|heart coherence (HC)|The heart coherence (HC) is based on the fact that the heart rhythm becomes more erratic with negative emotions such as anger and anxiety, and more ordered/coherent with sustained positive emotions such as appreciation, love, or compassion, leading to optimal performance and well-being. The HC program uses feedback from a simple pulse sensor to reflect changes of the emotional/psychological state, and to learn how to reduce stress and stabilize emotions.
16103337|NCT02137928|Drug|carboplatin periocular injection|20mg/2ml carboplatin periocular injection together with chemotherapy
16103550|NCT02136420|Drug|Placebo|Placebo
16103340|NCT02137902|Behavioral|Tobacco/Physical Activity Intervention|Telemedicine stage-tailored counseling intervention focused on increasing intrinsic motivation and goal setting for tobacco and physical activity, adherence with nicotine replacement therapy (NRT, patch plus gum or lozenge), and self-monitoring with a pedometer-based walking program.
16103341|NCT02137902|Behavioral|Diet plus BP/CHOL Intervention|Telemedicine stage-tailored counseling intervention focused on increasing intrinsic motivation, goal setting for managing HTN and HCL, and adherence with antihypertensives and statins with supportive dietary changes. Includes a native diet cookbook and medication bag.
16103342|NCT02137889|Drug|VAY736|VAY736 is a human immunoglobulin of the G class (IgG1/k) monoclonal antibody (mAb) designed to specifically bind the BAFF receptor. VAY736 binds primarily to B-cells through its fragment antigen binding (Fab) region, in human whole blood and spleen samples; it does not bind to natural killer (NK) cells, monocytes, dendritic cells, granulocytes, or platelets.
16103343|NCT02137876|Procedure|Blood Draws|Patients will be asked to provide blood for immune tests.Patients will not take any study medications, all the research will be performed on blood donated for the study.Patients will donate about 20mls of blood (2 tbls)to be used to determine the subject's blood group and tissue typing (genetic).Results and the patient's contact information will be maintained in a database that is accessible only by the investigators and study personnel conducting the study.For the duration of this study, the investigator will contact patients by phone to request additional samples when needed. Study staff may ask patients donate more blood on short notice (1 day). This will consist of 60-120 ml (6-12 tbls) of blood.The frequency of blood collection will not exceed more than 2 times per week.The total amount of blood collected from subjects will not exceed 360 ml (1.5 cups) within any eight week period throughout the two year timespan patients may be asked to participate in this study.
16103344|NCT02137863|Drug|Dexmedetomidine|"Intravenously 1μg/kg/10min administered just before the procedure.
~1 μg/kg/h administered during the angiography and was continued 1 hour after the angiography."
16103345|NCT02137863|Drug|0.9 % NaCl|During 12 hours before the procedure 3 ml/kg/h 0.9 % NaCl infusion and 1 ml/kg/h during the angioplasty and 12 hours after the procedure.
16103346|NCT02137863|Drug|0.9 % NaCl|"100 ml/10min infusion just before the angiography
~1 ml/kg/h infusion during the angiography and was continued 12 hours after the procedure"
16103348|NCT02137837|Drug|Fulvestrant|
16103349|NCT02137837|Drug|Anastrozole|
16103350|NCT02137837|Drug|Everolimus|
16103351|NCT02137837|Drug|Placebo - Anastrozole|
16103352|NCT02137837|Drug|Placebo - Everolimus|
16103353|NCT02137824|Procedure|sinus floor elevation|
16103354|NCT02137811|Other|MICK Assay|An automated microculture kinetic (MiCK) assay for measuring drug induced apoptosis in tumor cells; the MiCK assay for apoptosis provides a mechanism-based approach to studying effects of cytotoxic agents on tumor cells.
16103355|NCT02137798|Device|Radio-frequency catheter ablation|Radio-frequency atrial fibrillation catheter ablation includes circumferential PV isolation and voltage-map guided substrate modification, which means low voltage zone (amplitude < o.5 mV) will also be ablated.
16103356|NCT02137785|Drug|Aminolevulinic Acid (ALA)|20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
16103357|NCT02137785|Drug|Topical Solution Vehicle|Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
16103358|NCT02137785|Device|Blue Light Photodynamic Therapy Illuminator (BLU-U)|10 J/cm2 blue light delivered at 10mW/cm2
16103359|NCT02137772|Drug|Letermovir|Letermovir 240 mg / 480 mg tablets, or 240 mg / 480 mg intravenous solution in 250 mL to be infused over 60 minutes.
16103360|NCT02137772|Drug|Placebo|Placebo tablets, or intravenous solution in 250 mL to be infused over 60 minutes.
16103361|NCT02137759|Radiation|Standard Radiation Therapy|Radiation therapy to 60 Gy
16103362|NCT02137759|Drug|Standard Temozolomide|Temozolomide given orally
16103363|NCT02137759|Drug|Belinostat|Belinostat dose to be determined, given intravenously over 30-45 minutes
16103364|NCT02137746|Biological|Dendritic Cells DCVAC/PCa|DCVAC/PCa Experimental therapy
16103365|NCT02137733|Drug|Bisoprolol|
16103366|NCT02137733|Drug|Carvedilol|
16103367|NCT02137720|Behavioral|Telephonic Diabetes Self-Management Support|
16103368|NCT02137720|Other|Educational Print Materials|
16103369|NCT02137707|Drug|Gilenya|All patients will receive Gilenya
16103370|NCT02137694|Other|vaginal auto-takings and urinary test|vaginal auto-takings and urinary test
16103371|NCT02137681|Drug|Rituximab|Rituximab was given intravenously at a dose of 375mg/m(2) weekly for 2 consecutive weeks (Day 1, 8) in 2 cycles arm; or 4 consecutive weeks (Day 1, 8, 15, 22) in standard 4 cycles arm
16103372|NCT02137668|Drug|Oral Vancomycin|Oral Vancomycin is given to PSC or BA participants
16103373|NCT02137642|Drug|RM-131|Double blind RM-131 (100 ug) will be delivered once by injection during study procedure.
16103374|NCT02137642|Drug|Placebo|Double blind placebo will be delivered once by injection during study procedure.
16103375|NCT02137629|Drug|Vidaza®|The recommended starting dose for the first treatment for all patients regardless of baseline hematology values is Vidaza® 75mg/m2 subcutaneous(SC) injection or intravenous (IV) infusion, daily for 7 days.
16103376|NCT02137616|Drug|risperidone|Risperdal tablets
16103377|NCT02137616|Drug|olanzapine|olanzapine tablets
16103378|NCT02137616|Drug|Quetiapine|quetiapine tablets
16103379|NCT02137616|Drug|Aripiprazole|Aripiprazole tablets
16103380|NCT02137603|Other|Patients discharged home the same day following appendectomy|Patients are discharged to home on the same day following appendectomy with oral antibiotics.
16103381|NCT02137590|Dietary Supplement|Spanish Black Radish product|
16103382|NCT02137577|Procedure|DEB catheter|DEB catheter (trade name: Litos/Tulip)
16103383|NCT02137577|Procedure|common PTA balloon catheter|common PTA balloon catheter
16103384|NCT02137564|Drug|gamma secretase inhibitor PF-03084014|Given PO
16103385|NCT02137564|Other|pharmacological study|Correlative studies
16103386|NCT02137564|Other|laboratory biomarker analysis|Correlative studies
16105536|NCT02121717|Drug|Placebo|Take orally
16103387|NCT02137551|Other|ABM|The ABM involves synchronizing all medications to come due on the same say of the month and the individual receives a pre-appointment phone call from the pharmacy staff to review medications and identify any changes.
16103388|NCT02137538|Drug|Letrozole|
16103389|NCT02137538|Drug|Anastrozole|
16103390|NCT02137525|Drug|Morphine 6 mg|Intravenous infusion - delivering morphine 6 mg
16103391|NCT02137525|Drug|Fentanyl 100 µg|Fentanyl sublingual spray - single unit delivering 100 µg fentanyl
16103392|NCT02137525|Drug|Fentanyl 200 µg|Fentanyl sublingual spray - single unit delivering 200 µg fentanyl
16103393|NCT02137525|Drug|Fentanyl 400 µg|Fentanyl sublingual spray - single unit delivering 400 µg fentanyl
16103394|NCT02137525|Drug|Placebo Sublingual Spray|Matching sublingual spray - single unit delivering 0 µg fentanyl
16103395|NCT02137525|Drug|Intravenous Placebo|Matching intravenous infusion - delivering 0 mg morphine
16103396|NCT02137512|Device|Closed-Loop Control System|"This investigational device system included the following components:
~DiAs - a smart-phone medical platform;
~Dexcom G4 Platinum CGM system connected to DiAs via CGM receiver and USB-Bluetooth relay hardware;
~Roche Accu-Chek insulin pump connected to DiAs via wireless Bluetooth;
~Remote Monitoring Server connected to DiAs via 3G or local Wi-Fi network
~Modular Closed-Loop Control Algorithm Running on DiAs, which is of Control-to-Range (CTR) class"
16103397|NCT02137512|Device|Sensor-Augmented Pump (SAP)|"This commercial device system included the following components:
~Dexcom G4 Platinum CGM system;
~Roche Accu-Chek insulin pump"
16103398|NCT02137499|Device|geko device|Small transcutaneous electrical stimulator. Manufactured in UK by Firstkind UK Ltd, and licensed for use in humans
16103399|NCT02137473|Other|Human milk-based fortifier|
16103400|NCT02137473|Other|Bovine protein-based fortifier|
16103401|NCT02137447|Device|Negative Pressure treatment|
16103402|NCT02137434|Other|Dietary calcium|Dietary calcium from skimmed milk
16103403|NCT02137434|Dietary Supplement|Supplementary calcium|Supplementary calcium from calcium carbonate
16103404|NCT02137421|Dietary Supplement|Resveratrol (3, 4´, 5 trihydroxystilbene)|Resveratrol (RES) (3, 4´, 5 trihydroxystilbene)
16103405|NCT02137408|Dietary Supplement|Docosahexaenoic acid 200 mg|Participants will be randomized to 200 mg docosahexaenoic acid daily (1-200mg capsule) PO beginning at 18-20 weeks gestation through 6 weeks post-partum.
16103406|NCT02137408|Drug|Docosahexaenoic acid 1000 mg|Participants will be randomized to 1000 mg (5-200mg capsules) docosahexaenoic acid PO daily beginning at 18-20 weeks gestation through 6 weeks post-partum.
16103407|NCT02137395|Drug|Dexamethasone|dexamethasone administration, intravenously
16103408|NCT02137395|Drug|Placebo|saline administration intravenously
16103409|NCT02137382|Drug|Creon®|active comparator
16103410|NCT02137382|Drug|Creon N|experimental drug
16103411|NCT02137369|Drug|Selective serotonin re-uptake inhibitor|Escitalopram, 20mg-40mg daily or Sertraline 50-150 mg daily for 12 weeks
16103412|NCT02137369|Behavioral|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy, standardized, 16 sessions over 12 weeks.
16103413|NCT02137369|Other|Combination treatment (SSRI + CBT)|study participants who do not remit in the first 12 weeks will be offered combination treatment of both treatments for 12 more weeks.
16103414|NCT02137356|Radiation|standard dose pelvic radiation therapy|"radiation therapy to pelvis delivered using standard conformal or IMRT techniques.
~50.4-55 Gy"
16103415|NCT02137356|Drug|standard dose capecitabine|825 mg/m2 twice daily, 5 days a week (max dose 2000mg twice daily), only on days when radiation is delivered
16103416|NCT02137356|Drug|dose-escalated selinexor treatment|Selinexor oral drug will be given twice weekly according to the dose escalation schedule described in the protocol. Selinexor will be started on the day radiation begins, until the end of week 6.
16103417|NCT02137343|Drug|Rilotumumab|Rilotumumab is a fully human monoclonal antibody immunoglobulin G, type 2 (IgG2) against human hepatocyte growth factor/scatter factor (HGF/SF) that blocks binding of HGF/SF to its receptor MET, inhibiting HGF/SF/MET-driven activities in cells.
16103418|NCT02137343|Drug|Placebo|Placebo
16103419|NCT02137343|Drug|Cisplatin|A platinum containing chemo-therapy compound that reacts in vivo, binding to and causing crosslinking of DNA, which ultimately triggers apoptosis (programmed cell death)
16103420|NCT02137343|Drug|Capecitabine|A chemo-therapy prodrug that is enzymatically converted to 5-fluorouracil in the tumor, where it inhibits DNA synthesis and slows growth of tumor tissue.
16103421|NCT02137330|Device|Swallowable Obalon® Gastric Balloon|
16103422|NCT02137317|Device|LAPPE (locally adapted personal protective equipment)|"Hand: Nitrile gloves flexible enough to grip pesticide container firmly and in a length appropriate for mixing and spraying such as wrist length. They should not contain lining inside. In case, nothing is available disposable plastic bags can provide sufficient protection. In both cases wearing a cotton glove underneath.
~Upper and lower body: As thick or as heavy cotton blouse and trousers as can be worn and plastic sheets cut as a long poncho.
~Feet: Unlined rubber boots or shoes at least calf height with thick cotton socks underneath with possibility for trousers to be worn outside rubber boots or shoes."
16103423|NCT02137304|Device|Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA)|Cough Assist® (JH Emerson Compagny, Cambridge, MA, USA) mechanical insufflation to increase peak cough flow
16103424|NCT02137278|Drug|Vasoactive drug therapies|Continue current vasoactive therapy
16103425|NCT02137278|Other|Stop/reduce vasoactive drugs|Discontinuation of any vasoactive therapy or reduction of vasoactive drug therapies as much as possible according to clinical judgment.
16103426|NCT02137265|Drug|Clomiphene|Clomiphene citrate 50 mg orally daily
16103427|NCT02137265|Drug|Placebo|One pill every other day
16103428|NCT02137252|Drug|Naltrexone|
16103429|NCT02137252|Drug|Sugar Pill|
16103430|NCT02137239|Drug|Thymoglobulin|
16103431|NCT02137239|Drug|Belatacept|
16103432|NCT02137239|Drug|mycophenolate mofetil(MMF)|
16103433|NCT02137239|Drug|Corticosteroids|
16103434|NCT02137239|Drug|Everolimus(EVL)|
16103435|NCT02137239|Drug|Tacrolimus(TAC)|
16103436|NCT02137226|Drug|BI 695501|BI 695501, every two weeks for 48 weeks (25 injections in total)
16103437|NCT02137226|Drug|US-licensed Humira®|one injection every 2 weeks for 48 weeks (25 injections in total)
16105537|NCT02121704|Device|Magnetic Endoscope Imaging (Scope Guide)|
16103440|NCT02137200|Procedure|Immediate pushing|Women in this arm will be instructed to initiate pushing as soon as complete cervical dilation is documented.
16103441|NCT02137200|Procedure|Delayed pushing|Women assigned to delayed pushing will be instructed to wait for 60 minutes from complete cervical dilation before pushing. Women will be allowed to push earlier if they feel an irresistible urge to push, the fetal head is visible at the perineum, or the fetal heart tracing is non-reassuring.
16103442|NCT02137187|Procedure|AV junction ablation|AV junction ablation
16103443|NCT02137187|Device|CRT|Implantation of device for pacing and cardiac resynchronization therapy (CRT-P or CRT-D according to guidelines)
16103444|NCT02137187|Drug|Optimized drug therapy|Optimized drug therapy for heart failure and atrial fibrillation rate control
16103445|NCT02137187|Device|ICD|Implantable defibrillator (in control Group or in association with CRT in study Group) according to guidelines
16103446|NCT02137174|Other|Home and school visits|Each child in the intervention group received, in addition to the standard care at the diabetic clinic, home and school visits by a multidisciplinary team during one year.
16103447|NCT02137161|Drug|Dexamethasone+Tobramycin eye drop|dexamethasone 0.1% and tobramycin 0.3% ophthalmic suspension
16103448|NCT02137161|Drug|Bromfenac eye drop|bromfenac ophthalmic solution 0.09%
16103449|NCT02137148|Device|Use of Ultrasound to assist in needle placement|Use of the Sonic Window handheld Ultrasound device to assist in needle placement by providing a coronal image of the patient anatomy.
16103450|NCT02137135|Other|HAD scale|The anxiety/depression scale (HAD) was used to assess anxiety and depression.
16103451|NCT02137135|Other|The SF 12 test|The SF 12 test (SHORT FORM 12) was used to evaluate quality of life.
16103452|NCT02137135|Other|Visual analogue score|Visual analogue score vas used to evaluate pain.
16103453|NCT02137122|Device|Sham Stimulation|Administer 30 seconds of 2 mA electrical current to the head through saline soaked electrodes.
16103454|NCT02137122|Device|Transcranial Direct Current Stimulation|Participants will undergo 20 minutes of 2 mA electrical stimulation to the head through saline soaked electrodes.
16103455|NCT02137109|Drug|natalizumab|Administered as specified in the treatment arm.
16103456|NCT02137096|Drug|Etoposide phosphate|Etoposide is one of three drugs used in the high-dose conditioning phase
16103457|NCT02137096|Drug|Carboplatin|Carboplatin is one of the drugs used in the high-dose conditioning phase.
16103458|NCT02137096|Drug|Ifosfamide|Ifosfamide is one of the drugs used in the high-dose conditioning phase
16103459|NCT02137096|Procedure|Autologous Stem Cell Transplantation|Autologous Stem Cell Transplantation follows the high-dose chemotherapy phase of the arm.
16103460|NCT02137083|Drug|Docetaxel|75mg/m2 D2 every 21 days
16103461|NCT02137083|Drug|Fulvestrant|500mg D1, D15, D29, D57, every 28 days later
16103462|NCT02137070|Procedure|Bariatric Surgery Candidates|Participants who are intending to have bariatric surgery for weight loss
16103463|NCT02137070|Other|Non surgical/Community volunteers|Healthy adults with body mass index >35 who will not undergo bariatric surgery for weight loss
16103464|NCT02137044|Behavioral|Collaborative Care (CC)|Collaborative care (CC) is a systematic and integrated approach to improving the delivery and utilization of effective treatments for chronic pain and depression. The care was delivered through an interdisciplinary team, organized around a CC manager (CCM) who guided the patient through various aspects of care during the 16-week treatment phase. The team also included the patient's MS physician and the CC Supervisors, a group of clinicians who were experts of the study domain . The CCM offered all subjects care management, collaborative medical management, and psychosocial treatment appropriate to their problem area (i.e., pain, depression, or both) described below. If the patient had both pain and depression, he or she received care management and collaborative medical management for both.
16103465|NCT02137031|Device|Mini Link REAL-Time Transmitter|Children used the Mini Link REAL-Time Transmitter to measure glucose continuously for a minimum of three days per week for three months.
16103466|NCT02137018|Device|PPL fixation by BP|A surgical scar was performed on the abdominal linea alba and carried out deeply into a pocket between large abdominal muscle and abdominal fascia. A pocket was created between the two layers. 5cm PLL prosthesis was implanted and fixed by BP patch. The scar was sutured with absorbable stitches on subcutaneous incision and not absorbable stitches on the cutaneous layer.
16103467|NCT02137018|Device|PPL mesh|A surgical scar was performed on the abdominal linea alba and carried out deeply into a pocket between large abdominal muscle and abdominal fascia. A pocket was created between the two layers. 5cm PLL prosthesis was implanted and fixed by absorbable stichtes. The scar was sutured with absorbable stitches on subcutaneous incision and not absorbable suture on the cutaneous layer.
16103468|NCT02136992|Drug|Pirfenidone|Pirfenidone（200mg）tablets will be taken two tablets 3 times a day during the whole study process.
16103469|NCT02136992|Drug|placebo|placebo will be taken two tablets 3 times a day during the whole study process
16103470|NCT02136979|Drug|Propofol|group of patients with propofol-based anesthesia
16103471|NCT02136979|Drug|Sevoflurane|group of patients with sevoflurane-based anesthesia
16103472|NCT02136966|Other|MNP + IYCN counseling + cooking demonstrations|Growth monitoring and promotion sessions will take place every month at village level for all children 0-23 months of age and will serve as an entry point for all the interventions. During these sessions children under 24 months will be weighed monthly and screened for MAM and uncomplicated SAM for treatment in the community as well as complicated SAM for referral to health facility During the monthly sessions cooking demonstrations will take place in which the community Health workers will instruct the mother how to prepare a good complementary food for 6-23 months olds adding the MNP. These meals will be given to the child during the session. Mothers will be encouraged to prepare the same meal at home During the monthly sessions enhanced IYCN counseling will be given to the mothers of 6-23 months olds, using improved BCI messages developed based on the rapid assessment of practices and foods available in the community and adaptation of the WHO manual.
16103473|NCT02136953|Behavioral|Exercise|12 weeks of structured aerobic exercise, 3 times a week, following a two-stage graduated regimen: 1) Initial stage (weeks 1-4): 40-60% intensity, 15-30 min duration (+ 5 min warm-up/cool-down), and 2) Improvement stage (weeks 5-12): 60-80% intensity, 30-45 min duration. Adherence measures include self-reported exercise session logs and weekly phone checks by research assistants.
16103551|NCT02136420|Behavioral|No hypergravity training|Subjects do not receive normal Earth gravity
16103474|NCT02136953|Behavioral|Cognitive Behavioural Therapy (CBT)|CBT will be delivered in group format, 2 hours per week, for 12 consecutive weeks with 8-10 participants per group and will be conducted according to a session-by-session treatment manual that incorporates Exposure and Response Prevention (ERP) in the early phases of treatment and then increases emphasis on cognitive approaches for obsessions and compulsions outlined in step-by-step strategies.
16103475|NCT02136940|Drug|AMA0076|
16103476|NCT02136940|Drug|Placebo|
16103477|NCT02136927|Drug|SPARC1210|
16103478|NCT02136927|Drug|Reference1210|
16103479|NCT02136914|Drug|ADS-5102|Oral capsules to be administered once nightly at bedtime, for 25 weeks
16103480|NCT02136914|Other|Placebo|Oral capsules to be administered once nightly at bedtime, for 25 weeks
16103481|NCT02136901|Device|NUsurface® Meniscus Implant|The NUsurface Meniscus Implant is a Polycarbonate-Urethane (PCU)-based device reinforced with high tensile Ultra High Molecular Weight Polyethylene (UHMWPE) fibers. The product is available in different sizes, left and right, and with trials so as to allow the surgeon several size options for implantation. The NUsurface® Meniscus Implant, is designed to be conceptually analogous to the natural meniscus whose structural characteristics include a highly orientated collagen fiber network supports the large hoop stresses to produce better distribution of contact pressures within the knee joint. Restoring the distribution of joint loads post-meniscectomy is thought to reducing joint overload and to reducing pain.
16103482|NCT02136901|Drug|NSAID's and Non-surgical Treatment Options|Non-prescription drugs, creams, vitamins, and supplements, Prescription or Non-Prescriptions NSAIDs, Non-weight bearing and/or open chain physical therapy or self-administered exercise
16103483|NCT02136901|Drug|Intra-Articular Injections with Corticosteroids|Intra-articular injection of a corticosteroid, such as 40 mg of Triamcinolone (e.g. Aristocort or Kenalog).
16103484|NCT02136901|Drug|Intra-Articular Injections with Hyaluronic Acid (HA)|Intra-articular injection of a hyaluronic acid treatment, such as SYNVISC® HA Injections.
16103485|NCT02136888|Drug|Ponesimod Placebo|
16103486|NCT02136888|Drug|Moxifloxacin Placebo|
16103487|NCT02136888|Drug|Ponesimod 10 mg|
16103488|NCT02136888|Drug|Ponesimod 20 mg|
16103489|NCT02136888|Drug|Ponesimod 40 mg|
16103490|NCT02136888|Drug|Ponesimod 60 mg|
16103491|NCT02136888|Drug|Ponesimod 80 mg|
16103492|NCT02136888|Drug|Ponesimod 100 mg|
16103493|NCT02136888|Drug|Moxifloxacin 400 mg|
16103494|NCT02136875|Drug|Double dose of Salmeterol + Fluticasone Propionate|
16103495|NCT02136875|Behavioral|Self-management education on the use of a self-administered prescription for exacerbation.|Patients will be instructed to start treatment within 48 hours of experiencing an acute exacerbation of COPD and/or after starting their self-administered prescription.
16103496|NCT02136875|Drug|Self-administered prescription|"An Acute Exacerbation of COPD (AECOPD) is defined as a sustained worsening of dyspnea, cough or sputum production leading to an increase in the use of maintenance medication and/or supplementation with additional medication. In addition, exacerbations should be defined as either purulent or non-purulent.
~Standing prescriptions for exacerbation:
~1) Purulent exacerbation - Antibiotic: Avelox 400 mg daily for 5 days. 2a) Mild to moderate exacerbation - Combination therapy (SFP - Advair) to be increased as follows: If regular treatment is Advair 250/50 BID then dose should be increased to Advair 500/100 BID for 10 days; if regular treatment is Advair 500/50 BID then increase to Advair 1000/100 BID for 10 days.
~2b) Severe exacerbation - Prednisone (oral): 40 mg once daily for 7-10 days"
16103497|NCT02136823|Drug|sugar pill|
16103498|NCT02136823|Drug|Riluzole|
16103499|NCT02136823|Drug|Isradipine|
16103500|NCT02136823|Drug|Memantine|
16103501|NCT02136823|Procedure|Therapeutic muscle stretching|
16103502|NCT02136797|Biological|CMVpp65 Specific T-cells|
16103503|NCT02136784|Drug|morphine sulfate|Participants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance.
16103504|NCT02136784|Drug|hydrocodone|Participants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance.
16103505|NCT02136784|Drug|hydromorphone HCI|Participants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance.
16103506|NCT02136784|Drug|oxycodone|Participants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance.
16103507|NCT02136784|Drug|buprenorphine|Participants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance.
16103508|NCT02136784|Drug|oral tablet placebo|Participants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance.
16103509|NCT02136784|Drug|sublingual tablet placebo|Participants will receive randomly assigned order of study drug (opioid) and then have 7 days of testing with test days at least 3 days apart. Pain testing will utilize cold pressor test, in which the participant submerges his arm and hand in a bath of ice cold water to determine pain threshold and tolerance.
16103510|NCT02136771|Dietary Supplement|Vitamin D3|The treatment group receives 2,800 IU vitamin D3 per day as oily drops (Oleovit D3, producer: Fresenius Kabi Austria, A-8055 Graz) for 8 weeks
16103511|NCT02136771|Dietary Supplement|Placebo|
16103512|NCT02136758|Behavioral|CRC lifestyle modification program|Intervention group enrolled in lifestyle program in which they developed individualized therapeutic lifestyle plans to reduce cardiovascular risk.
16103513|NCT02136745|Behavioral|Relaxation Response Mind-Body Intervention|The Relaxation Response Mind-Body Intervention (RR-MBI) involved a 9-week group program conducted by a nurse practitioner or psychologist skilled in MBI, which included a GI-specific session conducted by a physician. The groups met once weekly for 1.5 hours. Three consecutive, mixed-disorder groups, ranging in size from 10 to 18 participants each. The program was multidimensional and included daily elicitation of the RR using a variety of methods (including breath focus, single-pointed focus, imagery, contemplation, yoga, and mindful awareness); cognitive reappraisal skills, health enhancing behaviors, and the promotion of optimism and acceptance. Throughout the course of treatment, participants were asked to elicit the RR at home each day for 15-20 minutes.
16103514|NCT02136732|Other|Active self-management intervention|Participants will set health goals at baseline. They will then receive, at minimum, a visit or a phone call to assess how progress and coaching toward meeting goals on a monthly basis from a nurse and/or social worker. The frequency and exact activities associated with the intervention are dependent on each participant's unique health goals.
16103515|NCT02136732|Other|Attention control phone calls|Participants will be called by a social service aide at 2, 4, 6, 8, 10, and 12 months.
16103516|NCT02136719|Procedure|bimanual uterine compression|bimanual uterine compression immediately after delivery of placenta for 5 minutes
16103517|NCT02136706|Procedure|Myocardial Perfusion imaging with 10 minute waiting period|After the Myocardial Perfusion Imaging testing the investigators will wait 10 minutes to take images and then wait the 30 minute standard of care time to take images.
16103518|NCT02136693|Drug|Psyllium fiber|3.5 g /day of pure Psyllium fiber for 180 days after STARR
16103519|NCT02136693|Drug|Placebo|3.5 g /day of inert compound for 180 days after STARR
16103520|NCT02136680|Other|CASA Education|Basic palliative care competencies for outpatient use.
16103521|NCT02136654|Behavioral|Culturally tailored diabetes program|Includes family member and peer support Includes communication training
16103522|NCT02136641|Drug|Midazolam|Was applied Midazolam 0.03 mg / kg, IV (in the vein), single dose.
16103523|NCT02136641|Drug|Midazolam+Fentanyl Combination|Was applied Midazolam 0.015 mg / Kg + Fentanyl 0.8mcg/kg, IV (in the vein), single dose.
16103524|NCT02136641|Drug|Midazolam+Ketamine Combination|Was applied Midazolam 0,015 mg / Kg + ketamine 0.25 mg / kg, IV (in the vein), single dose.
16103525|NCT02136628|Procedure|Method RTL|"The method consists of two lines of suture, each, over the fascial wound edge. It starts with a suture strand (in this study was used PDS number 0) in one end of the fascial wound where the suture is run longitudinally and parallel to the aponeurotic edge. The needle should go in and out at intervals of 1 cm away and always kept at 0.5 cm from the edge of the fascia. Upon reaching the opposite angle of the wound suture strand another repeating the same process on the fascial edge otherwise used. The ends of the two suture strands are tied in fascial angles.
~Thus the fascial wound is sutured with two lines of strengthening its edges. Then proceed to close the wound with continuous súrgete always ensuring that the suture lines remain anchored on suture reinforcement."
16103526|NCT02136589|Drug|dicrofenac and travoprost|dicrofenac drop 3 times a day travoprost 0.005% once daily
16103527|NCT02136576|Device|Sensodyne|Subjects will be instructed to brush with Sensodyne twice daily (2 minutes each time in the morning and the evening) during the duration of the study.
16103528|NCT02136576|Device|Crest Cavity Protection & MI Paste Plus|Subjects will be instructed to brush twice daily (2 minutes each time in the morning and the evening) using Crest Cavity Protection toothpaste. They will be instructed to apply MI Paste Plus (CPP-ACP with fluoride) twice daily to the study teeth after brushing their teeth. MI Paste Plus will be applied to the study teeth with a finger.
16103529|NCT02136576|Device|Clinpro 5000|Subjects will be instructed to brush with Clinpro 5000 twice daily (2 minutes each time in the morning and the evening) during duration of the study.
16103530|NCT02136550|Behavioral|Smoking cessation|Smoking cessation is a program that gives all the support to the subject: orientation, medications, exams, etc
16103531|NCT02136537|Device|Bilateral NMES legs|Stimulation with the geko(TM) device, Firstkind Ltd, UK. 4 hours per day, bilateral, applied to the skin overlying the common peroneal nerve
16103532|NCT02136537|Other|Best medical therapy|Treated according to local NHS protocol. At Imperial College Healthcare Trust, this will include diagnostic tests (medical interview and examination, ultrasound of blood vessels, diagnostic treadmill test, blood tests and Xrays as appropriate). This also includes lifestyle advice, treatment with appropriate drugs such as aspirin and statins, and supervised exercise.
16103533|NCT02136524|Drug|cobimetinib|Single, oral dose given as a tablet on Day 1 after a minimum 8 h fast
16103534|NCT02136524|Drug|cobimetinib|Single, oral dose given as 4 capsules on Day 1 after a minimum 8 h fast
16103535|NCT02136511|Drug|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily
16103536|NCT02136511|Drug|Rituximab|Rituximab administered intravenously starting at 375 mg/m^2 at Week 0 and continuing with a dose of 500 mg/m^2 at Weeks 2, 4, 6, 8, 12, 16, and 20.
16103537|NCT02136498|Drug|Varenicline|Standard 12 week course of varenicline, provided in both arms
16103538|NCT02136498|Behavioral|Cognitive-behavioral self-help|Standard self-help education for smoking cessation, delivered via mobile-optimized website accessible via smartphone.
16103539|NCT02136498|Behavioral|MyMAP (My Mobile Advice Program)|Same standard self-help intervention as in control arm + automatically-tailored support and advice for managing nicotine withdrawal symptoms + secure messaging with cessation counselor
16103540|NCT02136485|Behavioral|Mindfulness-based stress reduction (MBSR)|8 sessions of MBSR
16103541|NCT02136485|Other|waiting list control|
16103542|NCT02136459|Other|Small Tube size|An endotracheal tube of size 6.5 in females and 7.0 in males was used for endotracheal intubation of patients undergoing thyroid surgery
16103543|NCT02136459|Other|Large Tube size|An endotracheal tube of size 7.5 in females and 8.0 in males was used for endotracheal intubation of patients undergoing thyroid surgery
16103544|NCT02136446|Device|EchoGlo Nerve Block Catheter|Catheter used for a paravertebral anesthesia block
16103545|NCT02136446|Device|Pajunk® Nerve Block Catheter|Nerve Block Catheter
16103546|NCT02136433|Device|Tablet - self exercise|
16103547|NCT02136433|Other|GRASP self exercise|
16103548|NCT02136420|Drug|Promethazine|Subject receives promethazine
16103549|NCT02136420|Behavioral|Hyper gravity training|Subject receives hypergravity training before testing
16103552|NCT02136394|Other|Gastro-esophageal reflux|This is an observational study. The exposure is the gastro-esophageal reflux.
16103553|NCT02136381|Behavioral|LEAP intervention|"LEAP has 5 modules of tools and resources. LEAP is personalised based on information provided at different stages. The user determines the modules to complete (skipping or revisiting modules). Users can choose among 8 animated mentors (4 female; 4 male) to guide them through the intervention.
~Users will provide demographic data, health-related information, and current lifestyles in order to tailor the advice to be received.
~Advice will focus on adopting elements of a Mediterranean dietary pattern, increase physical activity, and improve social connectedness.
~Participants will receive 1) Mediterranean diet recipes; 2) a step counter to monitor physical activity goals; 3) advice in how to enhance social engagement and facilitate social roles"
16103554|NCT02136381|Behavioral|Control|"Thirty participants will be randomised to a minimal intervention comparator condition, where participants will be emailed a direct link to the National Health Service (NHS) choices 'LiveWell' website (http://www.nhs.uk/LiveWell/Pages/Livewellhub.aspx).
~The email will encourage the participants to access the health resources and information on the pages labelled men's health 40-60, men's health 60-plus, women's health 40-60, women's health 60-plus, as appropriate.
~Participants in the control group will be assessment after two months."
16103555|NCT02136368|Behavioral|Multi-modal exercise|Community-based group exercise classes following Canadian Centre for Activity and Aging exercise guidelines. Exercise classes consist of 5 min warm-up, 20 min aerobic exercise, 5 min aerobic cool-down, 10 min full-body resistance exercise, 5 min stretching (total 45 min)
16103556|NCT02136368|Behavioral|Mind-Motor Exercise|Square Step Exercise involves mimicking a stepping pattern demonstrated by an instructor. The stepping patterns become progressively difficult and involve forward, backward, lateral and diagonal movements on a 250cm long mat with 25cm square grids (15 min).
16103557|NCT02136368|Behavioral|Balance and range of motion exercises|Community-based group exercise designed to improve balance and range of motion of the joints (15 min)
16103558|NCT02136355|Radiation|Stereotactic Body Radiation Therapy plus Surgery|Stereotactic body radiation therapy followed by surgical resection
16103559|NCT02136342|Drug|chlorogenic acid|
16103560|NCT02136329|Drug|Sildenafil|"The active study drug, Revatio®, is the citrate salt of sildenafil, a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type-5 (PDE5). Sildenafil citrate is designated chemically as 1-[[3-(6,7-dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo [4,3-d] pyrimidin-5-yl)-4-ethoxyphenyl] sulfonyl]-4-methylpiperazine citrate.
~The active study medication is supplied in single use glass vials and as a clear, colourless, sterile, ready-to-use solution containing 10 mg (12.5 mL) of sildenafil. Each mL of solution contains 1.124 mg sildenafil citrate, 50.5 mg dextrose and water for injection.
~Sildenafil is manufactured under Good Manufacturing Practice (EU-GMP) by Pfizer Inc"
16103561|NCT02136316|Drug|ASP7962|Oral
16103562|NCT02136316|Drug|Placebo|Oral
16103563|NCT02136303|Dietary Supplement|S1: Dosage-dependency|kale extract: placebo, 1 mg lutein, 2 mg lutein, 5 mg lutein tagetes extract: placebo, 1 mg lutein, 2 mg lutein, 5 mg lutein, 10 mg lutein
16103564|NCT02136303|Other|S2: Kale extract versus kale purée|
16103565|NCT02136303|Other|S3: Kale extract: AMD-patients|
16103566|NCT02136290|Behavioral|Prepackaged meals|Portion-controlled prepackaged meals
16103567|NCT02136290|Behavioral|Usual Care|Usual care dietary counseling
16103568|NCT02136277|Drug|Hartmann's solution|Administered in 250ml boluses, until cardiac output has been optimised.
16103569|NCT02136264|Other|PCFA interventional dietary counselling|
16103570|NCT02136264|Other|conventional DASH diet counselling|
16103571|NCT02136238|Device|Hosmer 5XA voluntary opening hook|"Voluntary opening prosthetic terminal device (hand)"
16103572|NCT02136238|Device|TRS Grip 3 voluntary closing hook|"Voluntary closing prosthetic terminal device (hand)"
16103573|NCT02136225|Behavioral|Means restriction counseling|Health care providers will counsel parents on the risks of having a gun, particularly an unlocked gun, in the home where youth are present.
16103574|NCT02136212|Behavioral|Approach-positive AAT|
16103575|NCT02136212|Behavioral|Control AAT|
16103576|NCT02136199|Other|Active Implementation of ShareEBM Toolkit|
16103577|NCT02136199|Other|Passive Dissemination of Share EBM|
16103578|NCT02136186|Device|Philips Telehealth|patients will be provided with a philips home telemonitoring system post hospital discharge
16103579|NCT02136173|Device|Heliosphere bag (air filled balloon)|sequential balloons . Heliosphere bag (air filled balloon)
16103580|NCT02136160|Behavioral|attitude change, behavioral change|
16103581|NCT02136160|Behavioral|prevention program|
16103582|NCT02136147|Drug|methylphenidate medication|
16103583|NCT02136147|Drug|atomoxetine medication|
16103584|NCT02136147|Drug|lisdexamphetamine medication|
16103585|NCT02136147|Drug|guanfacine medication|
16103586|NCT02136134|Drug|Daratumumab|Daratumumab will be administered as an IV infusion or 16 mg/kg weekly for the first 3 cycles, on Day 1 of Cycles 4-9, and then every 4 weeks thereafter. As per protocol amendment-6 participants receiving treatment with daratumumab IV will have the option to switch to daratumumab SC 1800 mg on Day 1 of any cycle, at the discretion of the investigator.
16103587|NCT02136134|Drug|VELCADE (Bortezomib)|VELCADE will be administered at a dose of 1.3 mg/m2 subcutaneously (SC) on Days 1, 4, 8 and 11 of each 21-day cycle. Eight VELCADE treatment cycles are to be administered.
16103588|NCT02136134|Drug|Dexamethasone|Dexamethasone will be administered orally at 20 mg on Days 1, 2, 4, 5, 8, 9, 11 and 12 of the first 8 VELCADE treatment cycles.
16103589|NCT02136121|Device|da Vinci Sp Surgical System - Robotic|robotic assisted laparoscopic single-port system
16103590|NCT02136108|Other|OPENtext|Participants will receive 12 weeks of daily text messages sent from an automated system. The text messages will assist participants in managing their chronic pain.
16103591|NCT02136108|Other|OPENnav|Particpants will be linked with a RIPN PEER Navigator who will assisted them in managing their health care
16103592|NCT02136095|Procedure|Intraoperative fluorescent cholangiography (IFC)|A standardized protocol with IFC including concomitant angiography was performed during laparoscopic cholecystectomy.
16103593|NCT02136082|Behavioral|Asha Support + Training|
16103594|NCT02136082|Behavioral|Asha Support + Food|
16103595|NCT02136082|Behavioral|Asha Support + Training + Food|
16103597|NCT02136069|Drug|Etrolizumab|105 mg administered by subcutaneous (SC) injection once every 4 weeks (Q4W) until Week 52.
16103598|NCT02136069|Drug|Infliximab|5 mg/kg of infliximab will be administered by intravenous (IV) infusion at Weeks 0, 2, and 6 and then every 8 weeks until Week 46.
16103599|NCT02136069|Other|Placebo (IV)|Administered by (IV) infusion at Weeks 0, 2, and 6 and then every 8 weeks until Week 46.
16103600|NCT02136069|Other|Placebo (Injection)|Administered by SC injection Q4W until Week 52
16103601|NCT02136056|Behavioral|Self-management program (SMP)|A self-management course
16103602|NCT02136043|Device|PBASE system 1.1 (active treatment)|
16103603|NCT02136030|Drug|Liposomal amphotericin B|4mg/kg/day, IV infusion
16103604|NCT02136030|Drug|Amphotericin B-deoxycholate|1mg/kg/day, IV infusion
16103605|NCT02136004|Device|Closer VSS|At the end of a percutaneous endovascular procedure, the femoral arterial access site is closed with the Closer device to achieve arterial hemostasis.
16103606|NCT02135991|Behavioral|Getting To Outcomes|These sites will receive written materials, training, and on site technical assistance to use the Getting To Outcomes process to implement Project CHOICE at their sites.
16103607|NCT02135991|Behavioral|Project CHOICE|Sites will receive standard training for Project CHOICE.
16103608|NCT02135978|Other|Shoulder home exercise program|Patients receive instruction and practice on the shoulder home exercise program, receive a notebook with handouts including pictures and written instructions on how to perform the program, and receive a kit containing the exercise equipment. Patients are asked to perform the exercises at home 3 days a week over the next 3 years.
16103609|NCT02135965|Drug|2mg of Albuterol|2mg of Albuterol on metabolic rate
16103610|NCT02135965|Drug|4mg of Albuterol|4mg of Albuterol on metabolic rate
16103611|NCT02135965|Drug|100mg of Caffeine|100mg of caffeine on metabolic rate
16103612|NCT02135965|Drug|200mg of Caffeine|200mg of Caffeine on metabolic rate
16103613|NCT02135965|Drug|Albuterol 2mg & Caffeine 100mg|Albuterol 2mg and 100mg of Caffeine
16103614|NCT02135965|Drug|Albuterol 2mg and Caffeine 200mg|Albuterol 2mg and Caffeine 200mg on metabolic rate
16103615|NCT02135965|Drug|Albuterol 4mg and Caffeine 100mg|Albuterol 4mg and Caffeine 100mg on metabolic rate
16103616|NCT02135965|Drug|Albuterol 4mg and Caffeine 200mg|Albuterol 4mg and Caffeine 200mg on metabolic rate
16103617|NCT02135952|Procedure|SRP|SRP in four to six appointments lasting approximately 1 h each, using manual curettes and ultrasonic device under local anesthesia.
16103618|NCT02135952|Other|Placebo|Administration of placebo for 14 days started immediately after the first session of SRP.
16103619|NCT02135952|Drug|MTZ+AMX|Administration of antibiotics (metronidazole and amoxicillin) for 14 days started immediately after the first session of SRP.
16103620|NCT02135939|Behavioral|Diet|Whole foods plant based vegan diet vs the American Heart Association-recommended diet
16103621|NCT02135926|Device|Thrombectomy|Stent retriever are intended to restore blood flow in patients with acute ischemic stroke secondary to intracranial occlusive vessel disease by providing temporary bypass across the occlusion and/or by the non-surgical removal of emboli and thrombi. They may be used with aspiration and with the injection or infusion of contrast media and/or other fluids. For subjects enrolled in this protocol who are randomly assigned to undergo the thrombectomy procedure, the device will be used according to the Instructions-for-Use (IFU) that is packaged with the device.
16103622|NCT02135926|Other|Best medical care|Best medical treatment will be performed as detailed in established Standard Operating Procedures, following regional guidelines (American Heart Association (AHA), European Stroke Organisation (ESO), Deutsche Schlaganfall-Gesellschaft (DSG), local country, etc.).
16103623|NCT02135913|Dietary Supplement|Vitamin D|All subjects enrolled into the study will be prescribed standard of care Vitamin D
16103624|NCT02135900|Drug|Heliox|From the onset of sleep until 2:00 am, patients will be placed on heliox 70/30. At 2:00 am patients will be switched to CPAP for titration according to American Academy of Sleep Medicine (AASM) guidelines.
16103625|NCT02135887|Drug|MB-6|6# TID with meal
16103626|NCT02135887|Drug|Placebo|6# TID with meal
16103636|NCT02135861|Procedure|DCE-MRI scans|Subjects will be placed supine in the scanner and will be prepared for intravenous contrast agent administration. The contrast agent is administered using a power injector before imaging.
16103637|NCT02135861|Other|Gadobutrol|Gadobutrol at a dose less than or equal to 0.1 millimoles per kilogram (mmol/kg) will be given intravenously as a bolus using a power injector.
16103638|NCT02135848|Drug|GSK1278863|GSK1278863
16103639|NCT02135848|Drug|Placebo|Placebo
16103640|NCT02135835|Drug|Shenfu Zhusheye|
16103641|NCT02135835|Drug|5% glucose injection|
16103642|NCT02135822|Drug|nanoparticle albumin-bound paclitaxel|Nanoparticle albumin-bound paclitaxel is given at 120 mg/m2 intravenously on day 1 and 8 of each 21-day cycle. Number of cycles: 6 cycles.
16103643|NCT02135822|Drug|gemcitabine|Gemcitabine is given intravenously at 1000 mg/m2 on day 1 and 8 of each 21-day cycle. Number of cycles: 6 cycles.
16103644|NCT02135809|Device|WallFlex Pancreatic Stent|Temporary placement of the WallFlex Pancreatic Stent for treatment of refractory pancreatic duct strictures in patients with painful chronic pancreatitis. Stent will be removed after 3-6 months indwell.
16103645|NCT02135796|Other|Echocardiography|
16103646|NCT02135783|Procedure|Decompressive Craniectomy|A portion of frontal,temporal, and parietal bone was removed by craniectomy and the size of decompression was about 10x12 cm2.Intracerebral hematoma was evacuated by transcortical approach with the aid of a surgical microscope.
16103647|NCT02135783|Procedure|non-Decompressive Craniectomy|a simple hematoma removal by osteoplastic craniotomy group (HR) or Intracerebral hematoma was evacuated by transcortical approach with the aid of a surgical neuroendoscopyand the size of decompression was about 3x2.5 cm2.
16103648|NCT02135770|Drug|Unfractionated heparin|10 unit/kgBW/hour continuous infusion for 72 hours
16103649|NCT02135744|Behavioral|Bundle tool|Tool consists of 1. screening measures to identify the presence of various risk factors for COPD exacerbations and 2. Educational components for the disease of COPD.
16103650|NCT02135731|Other|Medication review software with pictures|The intervention is a self-service software program that displays each prescription on screen along with an image of the pharmaceutical product. Patients must use response buttons to describe adherence patterns and to advance through the questionnaire items.
16103651|NCT02135718|Device|ELLIPTA inhaler|ELLIPTA inhaler, placebo DPIwith 30 doses (2 strips with 30 blisters per strip containing lactose in strip first strip and Lactose blended with magnesium stearate in second strip)
16103652|NCT02135718|Device|Placebo Inhalation Aerosol (MDI)|Placebo inhaler MDI will be supplied containing aerosol propellant
16103653|NCT02135705|Drug|Lomitapide|As prescribed by Physician.
16103654|NCT02135692|Biological|Mepolizumab|Mepolizumab is a fully humanised IgG antibody (IgG1, kappa) with human heavy and light chain frameworks. Mepolizumab will be supplied as a lyophilised cake in sterile vials for individual use.
16103655|NCT02135692|Drug|SOC|Standard of Care (SOC) will differ by participant, however it will generally include oral corticosteroids and an inhaled controller medicine (an inhaled corticosteroid plus a long acting beta agonist) and/or short acting beta agonists
16103656|NCT02135679|Radiation|Radiotherapy|
16103657|NCT02135666|Procedure|Blood sampling|At Years 16 - 20 after first dose of the primary vaccination in HAB-084 (208127/084) study.
16103658|NCT02135653|Radiation|Radiotherapy|
16103659|NCT02135653|Other|Eischens Yoga|
16103660|NCT02135640|Drug|denosumab 60mg|solution
16103661|NCT02135640|Drug|denosumab 120 mg|solution
16103662|NCT02135640|Drug|placebo|solution
16103663|NCT02135627|Drug|TC-325 monotherapy on initial endoscopy ± radiation therapy, angioembolization, and/or surgery.|
16103664|NCT02135627|Other|Current standard therapy|
16103665|NCT02135614|Drug|Presatovir|Presatovir 200 mg (4 x 50 mg tablets) administered orally
16103666|NCT02135614|Drug|Presatovir placebo|Presatovir placebo tablets administered orally
16103667|NCT02135601|Other|Water colonoscopy|Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope. The water infusion involves putting warm sterile water into the colon to open up the colon for advancement of the colonoscope until the end of the colon (cecum) is reached. The water is delivered through scope irrigation channel by an infusion pump equipped with a foot switch which will be controlled by the endoscopist. Infused water used to cleanse residual fecal matter will be suctioned as needed to clear the colonic lumen.
16103668|NCT02135588|Drug|Combination TISSUE PLASMINOGEN ACTIVATOR (TPA) AND DORNASE ALFA (DNASE)|
16103669|NCT02135575|Behavioral|Spinning|After the baseline studies the pre and postmenopausal women will be randomized to spinning training groups and the intervention will last for 3 months. The spinning group will spin three times per week under guidance of a trained instructor. The training is heart rate monitored.
16103670|NCT02135562|Dietary Supplement|Dietary Intervention|Follow the Protein-Sparing Modified Fast (PSMF) intervention. This diet has participants consume enough lean beef, pork, poultry, and seafood to provide 1.2 grams of protein per kilogram of their obesity adjusted ideal body weight.
16103671|NCT02135562|Other|Informational Material|Receive carbohydrate reintroduction handout
16103672|NCT02135562|Other|Dietary Education|Receive education on nutrition label reading for carbohydrates
16103673|NCT02135562|Dietary Supplement|Weight Maintenance|weight maintenance diet consists of gradual addition of previously eliminated carbohydrate containing food groups to the high protein PSMF diet. During weight maintenance, consumption of non-starchy vegetables is unlimited
16103674|NCT02135562|Other|Average score of Obesity and Weight-Loss Quality of Life Questionnaire|Participants will take a tailored quality of life questionnaire. These scores will be averaged and a group mean reported. Higher scores indicate greater quality of life.
16103675|NCT02135549|Dietary Supplement|SugarDown|4 or 8 gram dose in tablet form, before meals, daily for one week
16103676|NCT02135549|Drug|Placebo Oral Tablet|Placebo comparator
16103677|NCT02135536|Biological|NGM282|NGM282
16103678|NCT02135523|Radiation|involved-field radiation therapy|Participants will receive involved-field radiotherapy (external beam radiotherapy or brachytherapy) over 45Gy for residual or locoregionally recurrent epithelial ovarian cancer after definitive treatment. Patients will be treated with 1.8-2.0Gy fraction, five times per week. It starts 2 weeks later of chemotherapy.
16103679|NCT02135510|Drug|metoclopramide|
16103680|NCT02135510|Drug|dexamethason|
16103681|NCT02135510|Drug|palonosetron|
16103682|NCT02135484|Drug|Alpharadin|50 kBq (0.0014 mCi)/kg body weight, administered by slow intravenous injection over 1 minute every 4 weeks for 6 cycles (6 doses total).
16103683|NCT02135471|Drug|acellular dermal matrix graft|On one side, the previously reflected partial-thickness flaps will be coronally positioned to entirely cover the acellular dermal matrix graft (ADMG), and also sutured with sling sutures using 6-0 bioabsorbable sutures.
16103684|NCT02135471|Drug|enamel matrix derivative|On the other side, the same procedure will be performed, with an additional layer of enamel matrix derivative between the acellular dermal matrix graft (ADMG) and the flap, and between the ADMG and the root surface by using a sterile brush.
16103685|NCT02135458|Other|Telemonitoring|
16103686|NCT02135458|Other|Conventional care|
16103687|NCT02135445|Drug|TAK-385|TAK-385 tablet
16103688|NCT02135445|Drug|Degarelix|Degarelix injection
16103689|NCT02135432|Drug|Ivacaftor|
16103690|NCT02135432|Drug|Placebo|
16103698|NCT02135406|Biological|CART-19 T cells|
16103699|NCT02135393|Dietary Supplement|13C5-folic acid or 13C5-6S-5-FormylTHF|Subjects with an insitu transjugular intrahepatic porto systemic stent shunt assigned to receive either a physiological 500 nmol (220 µg folic acid equivalent) dose of 13C5-folic acid or 13C5-6S-5-FormylTHF at the time of routine shunt venography to check patency followed by portal venous sampling at pre defined time points for 85 minutes and then given 13C5-6S-5-FormylTHF ator 13C5-folic acid at their next annual venography patency check with portal venous sampling at pre defined time points for 85 minutes
16103700|NCT02135380|Biological|Autologous Stromal Vascular Fraction (SVF)|Study arm A subjects will receive single dose of autologous adipose derived Stromal Vascular Fraction (SVF) intravenously.
16103701|NCT02135380|Biological|Autologous Adipose Derived MSCs (ADMSCs)|Study arm B subjects will receive total 3 doses of 2 million per kg body weight adipose tissue derived Ex-vivo expanded Mesenchymal stem cells (MSC) intravenously each. All the three doses will be given at weekly intervals.
16103702|NCT02135380|Other|Control|Standard Therapy
16103703|NCT02135367|Biological|PRP|injections of Platelet rich Plasma
16103704|NCT02135354|Drug|Azithromycin|"From day 1 up to and including day 3: 500 mg azithromycin PO once a day
~From day 4 up to and including day 90: 250 mg azithromycin PO once every 2 days"
16103705|NCT02135354|Drug|Placebo|"From day 1 up to and including day 3: 500 mg placebo PO once a day
~From day 4 up to and including day 90: 250 mg placebo PO once every 2 days"
16103706|NCT02135341|Drug|Botulinum toxin A|BoNT-A 100 units in normal saline 10ml, suburothelial injection at 20 sites of bladder wall in single treatment
16103707|NCT02135341|Drug|Botulinum toxin A|BoNT-A 100 units in normal saline 10ml, suburothelial injection 50 U in 10 sites and 50 U urethral injections in 5 sites
16103708|NCT02135328|Behavioral|Radio Story|"For the purposes of this study a Radio Story is an audio recorded story of about a family's success story about type 2 diabetes mellitus prevention and management."
16103709|NCT02135328|Behavioral|Audio brochure|The control participants listened to an adio version of a standard brochure about prevention and management of type 2 diabetes.
16103710|NCT02135315|Drug|Isosorbide Dinitrate|"continuous infusion of Isosorbide dinitrate (40 mg per 40 ml) depending on the systolic blood pressure value.
~SBP: under 120 mmHg : no drug SBP: 120 to 130: 1 mg per hour SBP: 130 to 140: 2 mg per hour SBP: 140 to 150: 3 mg per hour SBP: 150 to 160: 4 mg per hour SBP: above 160 mmHg : 6 mg per hour"
16103711|NCT02135315|Drug|Labetalol or nicardipine|continuous infusion of Labetalol (Trandate) or Nicardipine (Loxen) are used if the arterial pressure objectives are not reached with the Isosorbide Dinitrate alone.
16103712|NCT02135302|Drug|eravacycline|Eravacycline (TP-434) is a parenteral and oral antibiotic of the tetracycline class that is highly active in vitro and in established animal infection models against both nosocomial and community-acquired methicillin-susceptible or -resistant Staphylococcus aureus strains, vancomycin-susceptible or -resistant Enterococcus faecium and Enterococcus faecalis, and penicillin-susceptible or -resistant strains of Streptococcus pneumoniae. In addition, eravacycline is highly active against clinically important species of Enterobacteriaceae (including those isolates that produce extended-spectrum β-lactamases and/or are carbapenem-resistant), Acinetobacter baumannii, and anaerobes.
16103713|NCT02135276|Drug|eravacycline|All subjects will receive s single dose of intravenous eravacycline (1.5 mg/kg) administered over 60 minutes on Day 1. This study includes an up to 21-day Screening Period, a 5-day Treatment Period, and an End of Study Visit occurring approximately 2 weeks (±2 days) after study drug administration. Approximately 12 subjects will be enrolled: 6 subjects with ESRD and 6 healthy subjects with normal renal function. Healthy subjects will be matched to renally impaired subjects in gender, age, and body mass index (BMI).
16103714|NCT02135263|Drug|Methylphenidate|10 mg as a single dose followed by blood samples for the next 33 hours
16103715|NCT02135263|Drug|Enalapril|10 mg as a single dose followed by blood samples for the next 72 hours
16103716|NCT02135250|Drug|Xinkeshu tablets|4 Xinkeshu tablets are given three times per day
16103717|NCT02135250|Other|placebo|the placebo is not drug.
16103718|NCT02135237|Behavioral|Prize Contingency Management for Alcohol Abstinence|The systematic reinforcement of desired behaviors and the withholding of reinforcement for undesired behaviors
16103719|NCT02135237|Behavioral|Standard Care|
16103720|NCT02135224|Drug|Fentanyl|
16103721|NCT02135224|Drug|Normal saline|
16103722|NCT02135211|Behavioral|Lifestyle counseling|
16103723|NCT02135198|Drug|2 mg AZD7325|A single 2 mg oral dose of AZD7325
16103724|NCT02135198|Drug|10 mg AZD7325|A single 10 mg oral dose of AZD7325
16103725|NCT02135198|Drug|Placebo|A single oral dose
16103726|NCT02135185|Other|custom work endurance|Experimental: Rehabilitation effort
16103727|NCT02135185|Behavioral|dietary management adapted to the nutritional status|dietary management adapted to the nutritional status
16103728|NCT02135172|Behavioral|Sitting|
16103729|NCT02135172|Behavioral|Standing|
16103730|NCT02135172|Behavioral|Walking|
16103731|NCT02135159|Drug|TDM1|administration of the TDM1 by IV perfusion
16103732|NCT02135159|Radiation|Brain Sequential RT|local RT
16103733|NCT02135146|Drug|Plasmalyte 3ml/kg/hr group|This group will have intravenous plasmalyte fluid limited to a rate of 3 ml/kg/hr. and a nexfin monitor placed on them
16103734|NCT02135146|Drug|Plasmalyte 6ml/kg/hr group|This group will have intravenous plasmalyte fluid limited to a rate of 6 ml/kg/hr. and a Nexfix Monitor placed on them
16103735|NCT02135133|Drug|Idelalisib|150 mg BID Oral Daily
16103736|NCT02135133|Drug|Ofatumumab|Ofatumumab will then be administered at 1000 mg weekly to complete 8 weeks (days 64, 71, 78, 85, 92, 99, 106) throughout Cycles 3 and 4. This will be followed by monthly ofatumumab on weeks 20, 24, 28, 32 to complete 4 additional cycles (5-8).
16103737|NCT02135120|Drug|Combined spinal epidural anesthesia technique with intrathecal morphine|
16103738|NCT02135120|Drug|A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block|
16103739|NCT02135120|Drug|A combination of combined spinal-epidural (with intrathecal morphine) and femoral nerve block as well as sciatic nerve block|
16103740|NCT02135107|Drug|Rabeprazole|Rabeprazole 10 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded).
16103741|NCT02135107|Drug|Rabeprazole|Rabeprazole 20 mg was administered orally twice daily during the treatment period for 8 weeks (unblinded).
16105570|NCT02121483|Drug|empagliflozin medium dose|
16103742|NCT02135107|Drug|Rabeprazole|Rabeprazole 10 mg or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered once daily during the maintenance period (double-blind).
16103743|NCT02135107|Drug|Rabeprazole|Rabeprazole 10 or 20 mg were administered orally twice daily during the treatment period (unblinded), and 10 mg was administered twice daily during the maintenance period (double-blind).
16103744|NCT02135094|Device|Active ultrasound therapy device|low intensity continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2 for treatment duration of 4 hours per day
16103745|NCT02135094|Device|Placebo ultrasound therapy device|The placebo device appears and operates identically to the active device except that it does not emit ultrasound.
16103746|NCT02135068|Device|Medtronic MiniMed Closed Loop (CL) System|The Medtronic MiniMed Closed Loop (CL) System is an investigational system that uses some commercially available products. An investigational Enlite 2 glucose sensor measures the sensor glucose. The glucose sensor signal is sent to the insulin pump. From the insulin pump the sensor glucose is sent through the translator, which then relays the signal on to a controller. An Android Mobile Device (off the shelf) has the control algorithm installed. This device is known as the controller. The controller serves as the control center for the Android system, receiving data from the sensor and pump components, feeding the data to its control algorithm, issuing delivery commands to the pump to apply the algorithm's recommend therapy, and providing a means to monitor the system.
16103747|NCT02135068|Other|Snacking|Up to 45 g of oral glucose via Gatorade
16103748|NCT02135055|Other|blood sample collection|Patients were included 1 hrs later(before the study drug is administrated), 3 d and 7 d after sedation with midazolam, blood sample is collected. Flow cytometry is performed to test the mHLA-DR and according the value of mHLA-DR, assign the participant to the 4 groups as described in the arm.
16103749|NCT02135055|Drug|Midazolam|The loading dose of midazolam is 0.03-0.3 mg/kg, intravenous injected slowly for 10 minutes, then 0.04-0.2 mg/kg/h for maintenance of sedation.
16103750|NCT02135055|Drug|Morphine|Morphine is the only analgesic drug that permitted to use. 2 mg morphine is given a bolus when the participant feel pain. If the pain is not alleviated, 0.4-1 mg/h morphine is maintained.
16103751|NCT02135055|Procedure|Sedation interruption|Sedation interruption is performed at 8 am every morning.
16103752|NCT02135042|Drug|Cisplatin|Given IV
16103753|NCT02135042|Other|Clinical Observation|Undergo clinical observation
16103754|NCT02135042|Drug|Fluorouracil|Given IV
16103755|NCT02135042|Drug|Gemcitabine Hydrochloride|Given IV
16103756|NCT02135042|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16103757|NCT02135042|Other|Laboratory Biomarker Analysis|Correlative studies
16103758|NCT02135042|Drug|Paclitaxel|Given IV
16103759|NCT02135042|Other|Quality-of-Life Assessment|Ancillary studies
16103760|NCT02135029|Drug|Bococizumab (PF-04950615;RN316)|150 mg every 2 weeks by subcutaneous injection for 24 weeks
16103761|NCT02135029|Drug|Atorvastatin|Atorvastatin PO QD
16103762|NCT02135029|Other|Placebo for Bococizumab (PF-04950615;RN316)|150 mg every 2 weeks by subcutaneous injection for 24 weeks
16103763|NCT02135029|Other|Placebo for atorvastatin|PO QD
16103764|NCT02135016|Drug|1% lidocaine|epidural anesthesia with 1% lidocaine 10ml before propofol TCI
16103765|NCT02135016|Drug|2% lidocaine|epidural anesthesia with 2% lidocaine 5ml before propofol TCI
16103766|NCT02135016|Drug|0.9% normal saline|epidural anesthesia with 0.9% normal saline 5ml before propofol TCI
16103767|NCT02135003|Other|patient-selected care buddy|Patient-selected Care buddy intervention: In addition to standard of care, pre-ART patients randomized to this arm were requested to choose a care buddy who was aware of the patient's HIV infection and resided in the same household or in close proximity. Care buddies attended at least two HIV health education sessions similar to those provided to study participants. Information on HIV, and the importance of adhering to scheduled clinic visits and to prescribed medications will be emphasized. Buddies were requested to remind participants to take their prophylactic treatments, and remind them of clinic appointments
16103768|NCT02134990|Drug|Oshadi D and Oshadi R|Anti cancer agents
16103769|NCT02134990|Drug|Docetaxel|Chemotheraphy
16103770|NCT02134977|Drug|Leuprorelin Acetate|Leuprorelin Acetate SR 11.25 mg Injection Kit
16103771|NCT02134964|Drug|OLT1177 Capsules|OLT1177 Capsules are an experimental drug.
16103772|NCT02134964|Drug|Placebo Capsules|Placebo Capsules are identical in all ways to the study drug, but contain no active pharmaceutical ingredient.
16103773|NCT02134951|Drug|Ketamine|intravenous infusion of saline solution with ketamine
16103774|NCT02134951|Drug|Normal saline|Normal saline will be used for placebo in this group
16103775|NCT02134938|Dietary Supplement|Konjac Glucomannan|Konjac Noodles (Wellbond Import Export Inc.), Vegan Konjac Shrimp (Sophie's Kitchen), Konjac Gel Cubes
16103776|NCT02134925|Other|Laboratory Biomarker Analysis|Correlative studies
16103777|NCT02134925|Biological|MUC1 Peptide-Poly-ICLC Vaccine|Given SC
16103778|NCT02134925|Other|Quality-of-Life Assessment|Ancillary studies
16103779|NCT02134925|Other|Saline|Given SC
16103780|NCT02134912|Drug|crizotinib|Given PO
16103781|NCT02134912|Drug|pemetrexed disodium|Given IV
16103782|NCT02134912|Other|laboratory biomarker analysis|Correlative studies
16103783|NCT02134912|Other|pharmacological study|Correlative studies
16103784|NCT02134899|Drug|Everolimus|Change from a calcineurin inhibitors-based immunosuppression to an everolimus-based immunosuppression
16103785|NCT02134899|Drug|Calcineurin inhibitors maintenance|Usual treatment
16103786|NCT02134886|Drug|Erlotinib Hydrochloride|Given PO
16103787|NCT02134886|Other|Laboratory Biomarker Analysis|Correlative studies
16103788|NCT02134886|Other|Pharmacological Study|Correlative studies
16103789|NCT02134886|Other|Quality-of-Life Assessment|Ancillary studies
16103827|NCT02134587|Other|Multifaceted educational intervention|"Application of questionnaire of knowledge, attitudes and skills in pharmacovigilance.
~Lecture regarding the theoretical framework and importance of pharmacovigilance, and distribution of educational material
~Distribution of educational material
~Practical class to explain the correct fill of adverse drug events form
~Reapplication of questionnaire of knowledge, attitudes and skills in pharmacovigilance."
16105571|NCT02121483|Drug|empagliflozin high dose|
16103790|NCT02134873|Other|sucrose|Sucrose will be administered by a research nurse experienced in neonatal intensive care using a standardized procedure and timing consistent with policies in the participating units, including: (a) administering sucrose 2 minutes prior to the heel lance to ensure peak effects; (b) giving the total volume of sucrose drop by drop via syringe on the anterior surface of the tongue, as tolerated, over a period of up to 1 minute to allow for individual infant swallowing rates and to ensure analgesic effects are sustained during the heel lance procedure; and (c) offering a pacifier for non-nutritive sucking (NNS) immediately following sucrose administration.
16103791|NCT02134860|Other|Bed rest|8 days of full bed rest
16103792|NCT02134860|Other|OGTT|Oral glucose tolerance test with 75 g of glucose before and after bed rest
16103793|NCT02134860|Other|IVGTT|Intravenous glucose tolerance test mimicking the glucose profile from the corresponding OGTT
16103794|NCT02134860|Other|Cognitive testing|Daily testing of memory and concentration using standardized tests
16103795|NCT02134860|Other|Muscle and fat biopsies|Biopsies will be obtained before and after bed rest
16103796|NCT02134860|Other|Dual-energy X-ray Absorptiometry (DXA) scan|DXA scan to evaluate fat and muscle distribution before and after bed rest
16103797|NCT02134860|Other|MRI|Functional MRI to evaluate cognitive function and abdominal MRI to evaluate visceral fat before and after bed rest
16103798|NCT02134847|Other|SCS intervention schedule|
16103799|NCT02134834|Drug|OP0595|Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation
16103800|NCT02134834|Drug|Placebo|Five cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation
16103801|NCT02134821|Procedure|Surgery for lumbar spinal stenosis|decompression with or without fusion for lumbar spinal stenosis
16103802|NCT02134808|Drug|Creatine|Creatine is a nutritional supplement.
16103803|NCT02134808|Drug|Placebo|The placebo is an inactive ingredient similar in appearance, weight and density to the active treatment.
16103804|NCT02134795|Device|TNM (trade name), a form of brainstem Stimulation|The device is worn like a music headset and the patient lies on a wedge pillow while the device is active. Each session lasts under 20 minutes. The stimulation is non-invasive and non-electrical. The form of stimulation acts on the brainstem.
16103805|NCT02134782|Behavioral|Individualized Yoga Intervention Group|These children will not receive a study-supplied iPad. Use of child or hospital supplied iPad games, music, movies or books will be permitted without any modification, encouragement or discouragement of these activities. There will be no restrictions on concomitant medications. Standardized sleep hygiene recommendations will be provided.
16103806|NCT02134782|Other|iPad Activity Control Group|These children will not receive yoga during the 3 week iPad activity period; instructors will receive specific training to ensure that no yoga occurs during this time frame. Use of child or hospital supplied iPad activities will be permitted instead of the study-supplied iPad activities. There will be no restrictions on concomitant medications. Standardized sleep hygiene recommendations will be provided.
16103807|NCT02134769|Device|Bionecteur|Using Bionecteur at each lumina of the catheter; handling according to institutional guideline
16103808|NCT02134756|Drug|NutraStem Active|
16103809|NCT02134756|Drug|NutraStem Placebo|
16103810|NCT02134743|Procedure|Implant surgery|Dental implant surgery with two different kinds of implant surface (SLA and modified SLA)
16103811|NCT02134730|Behavioral|FRIENDS for life|Friends for life (FFL). The FFL is a prevention program created by professor Paula Barrett, Brisbane, Australia. It is based on cognitive behavioral treatment strategies, for example the link between thoughts and feelings, negative and positive thoughts, breathing and relaxing exercises, support from others, breaking challenging situation in smaller steps, and problem-solving techniques. The children's workbook comprises practice-sheets for use during class, and homework assignments. The group leader manual comprises detailed instructions to all exercises.
16103812|NCT02134717|Drug|all subjects will receive maraviroc 300mg orally twice a day for 6 weeks|
16103813|NCT02134717|Procedure|Bronchoscopy with bronchoalveolar lavage|Bronchoscopy employs a flexible instrument that is inserted into the trachea and proximal airways after topical anesthesia. Bronchoalveolar lavage involves the instillation of saline solution through the bronchoscope into the airways followed by recovery under suction to collects lung fluid containing cells and proteins.
16103814|NCT02134717|Procedure|venipunctures|Venipunctures will be performed at study entry, after two weeks, and at the end of the study to collect blood for research studies and safety laboratories.
16103815|NCT02134717|Procedure|Skin biopsy|For subjects with sarcoidosis skin lesions, an optional skin biopsy specimen may be collected for research studies.
16103816|NCT02134704|Other|Data recording with all sensors|The sensors will be placed in the child body and will allow the collection of all the data of the trial.
16103817|NCT02134691|Behavioral|Prolonged Exposure|
16103818|NCT02134691|Behavioral|Applied Relaxation|
16103819|NCT02134678|Behavioral|self-system therapy|
16103820|NCT02134678|Behavioral|cognitive therapy|
16103821|NCT02134652|Other|diagnostic bedside ultrasound|"Patients enrolled in this study will undergo bedside ultrasound during their initial presentation to the emergency department. Ultrasound imaging protocols include the following:
~FAST Exam - Standard images will be obtained using the abdominal transducer. Images include the following: 1) sub-xyphoid 2)right upper quadrant (with right thorax) 3)left upper quadrant (with left thorax) and 4) suprapubic
~Right Upper Quadrant Exam - Standard images will be obtained using the abdominal transducer. Images include the following: 1) Long axis of the gallbladder 2) Transverse axis of the gallbladder fundus 3) Transverse axis of the gallbladder body and 4) Transverse axis of the gallbladder neck."
16103822|NCT02134639|Procedure|68Ga-DOTATOC PET-CT Imaging|
16103823|NCT02134626|Drug|Simvastatin|40mg / pill, one pill orally once a day for three months
16103824|NCT02134626|Drug|Placebo pill|
16103825|NCT02134613|Other|99mTc-anti-TNF-alpha Scintigraphy|99mTc-anti-TNF-alpha Scintigraphy will be analysed and discussed by physicians who are in charge of the patients.
16103826|NCT02134600|Dietary Supplement|Omega-3 enriched fruit juice|"Different doses of omega-3 will be administered to five different groups:
~400, 800, 1200, 2400 and 3000 mg/m2."
16103828|NCT02134574|Biological|hematologic malignancy|hematologic malignancy with a sampling of blood
16103829|NCT02134561|Behavioral|psychological interview|
16104703|NCT02127970|Drug|Dalbavancin|Dalbavancin IV infusion over 30 minutes.
16103830|NCT02134561|Radiation|MRI|This MRI is a specific intervention assign to the subjects of the study, that's why it is an interventionnal study
16103831|NCT02134561|Other|cognitive tests|
16103832|NCT02134561|Other|neurological tests|
16103833|NCT02134522|Device|Continuous positive airway pressure (CPAP).|Continuous positive airway pressure is a commonly prescribed therapy for obstructive sleep apnea which is recommended for the treatment of obstructive sleep apnea in children and adults.
16103834|NCT02134509|Behavioral|Experimental App|It is comprised of twenty-two modules of 10-15 minutes each, designed to teach behavioral strategies for smoking cessation using psychoeducation-based audio and videos, animations to reinforce key concepts, and in vivo exercises. In addition, 5 bonus modules become available upon completion of earlier modules; these may be accessed for additional practices to bolster other modules
16103835|NCT02134509|Behavioral|Active Comparator App|It is comprised of 6 prompts per day asking individuals about their experience, behavior, and smoking habits, for 22-days.
16103836|NCT02134496|Procedure|assessment of motorfunction in PACU|assessment of motorfunction in PACU after spinal anesthesia
16103837|NCT02134483|Biological|Parathyroid allo-transplantation|parathyroid allotransplantation with a new tecnique without immunosuppression
16103838|NCT02134470|Drug|Testosterone supplementation|Low-dose testosterone supplementation will be facilitated by using hormone patches. For pharmacokinetic aspects circadian profiles of saliva/blood/urine will be measured under native conditions and under exogene hormone application. In addition, cross-reactivity of a standardized exercise bout and hormone application will be of further interest.
16103839|NCT02134457|Biological|ranibizumab|
16103840|NCT02134444|Behavioral|Experimental group|Experimental group will receive a game-based exercise program delivered at home. This includes provision of a head-mounted motion mouse. This provides a treatment tool applied to gaze control, and allows incorporation of balance exercises. It also allows many different therapeutic exercises to be coupled to a wide range of inexpensive commercial computer games. Participants will attend 3 clinical sessions during which time the home therapy programs will be established and training in the use of the motion mouse and games will be provided. The treating physiotherapist will attend the participant's home to ensure proper set-up and operation of the computer applications. Participants will be asked to perform their respective home programs four times per week for 20 minutes per session.
16103841|NCT02134444|Behavioral|Control group|Control group will receive a vestibular exercise program which will include the Herdman gaze stabilization exercises and balance training program. This program is presently a standard of vestibular care. Participants will attend an out-patient physical therapy clinic once a week for 12 weeks. The program also includes a 20 minute home exercise program prescribed 4 times per week.
16103842|NCT02134431|Device|flexible sigmoidoscopy or colonoscopy with biopsies|Lower endoscopy with biopsies (specifically either colonoscopy or flexible sigmoidoscopy) in both HIV-positive subjects already on oral tenofovir , as well as HIV negative subjects. Biopsies will be taken to laboratory for quantification of HIV-1 and drug levels of tenofovir.
16103843|NCT02134418|Behavioral|CBT of irony comprehension|Over the course of intervention participants will analyze and discuss short film scenario's that end with an ironic statement, and will experience completing short scenario's that contain irony. Intervention will include 5 sessions, each session will take 40 minutes, 3-5 subjects will participate in each group.
16103844|NCT02134405|Drug|Rebamipide|Rebamipide 100mg tid
16103845|NCT02134405|Drug|Placebo (for Esomeprazole)|Sugar pill manufactured to mimic Esomeprazole
16103846|NCT02134405|Drug|Esomeprazole|Esomeprazole tablets 20mg o.d. for 8 weeks
16103847|NCT02134392|Biological|Fecal Microbiota Transplantation|250 ml of a fecal suspension diluted in saline will be administered via colonoscopy or enema in patients with recurrent c-diff.
16103848|NCT02134379|Device|Medtronic ICDs, CRT-Ds, and CRT-Ps|Any Medtronic implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy (CRT) device. Device must have capacity to measure thoracic impedance as described in protocol. This includes the majority of FDA-approved Medtronic devices currently in use.
16103849|NCT02134366|Drug|Clobazam|Comparison of AED use in Epilepsia Partialis Continua
16103850|NCT02134366|Drug|Clonazepam|Comparison of AED use in Epilepsia Partialis Continua
16103851|NCT02134366|Drug|Lorazepam|Comparison of AED use in Epilepsia Partialis Continua
16103852|NCT02134353|Drug|Inhaled mannitol|Inhaled mannitol 400 mg BD for 26 weeks
16103853|NCT02134353|Drug|Placebo Comparator: Arm B - Control|Placebo Comparator: Arm B - Control BD for 26 weeks
16103854|NCT02134340|Drug|[I-124]-CPD-1028 Injection|A single intravenous dose of [I-124]-CPD-1028 Injection will be given at Visit 2 (within 21 days of screening Visit 1), and may be followed by whole body PET/CT imaging approximately 3 hours post-injection. PET/CT imaging will occur at Visit 3 (2-3 days after Visit 2) and Visit 4 (5-7 days after Visit 2). PET/CT imaging may also occur at Visit 5 (16-18 days after Visit 2). Visit 6 (28 +/- 2 days after Visit 2) is a follow-up telephone call for a post-treatment safety assessment. At Visits 2-5, whole body biodistribution and tumour uptake will be assessed. At all visits, safety will be assessed.
16103855|NCT02134340|Biological|CPD-1061|[Optional] An intravenous dose of 0.4, 1.4 or 6 mg/kg of body weight of CPD-1061 may be given 1-2 hours prior to injection of [I-124]-CPD-1028 at Visit 2. The decision to use CPD-1061 and the dose amount is based on an adaptive design and is dependent on interim reviews of imaging data.
16103856|NCT02134327|Drug|Combination of Dexmedetomidine with Midazolam|
16103857|NCT02134314|Drug|C1 Esterase Inhibitor|C1 Esterase Inhibitor 50 units per kilogram intravenous infusion administered on day of transplant, and another dose at 24 hours post-operatively. Total: 2 doses
16103858|NCT02134314|Drug|Placebo|Placebo medication identical to study drug (C1 esterase inhibitor) volume will be administered on day of transplant, and another dose at 24 hours post-operatively. Total: 2 doses
16103859|NCT02134301|Drug|Oritavancin|
16103860|NCT02134288|Drug|Belatacept|
16103861|NCT02134288|Drug|Everolimus|
16103862|NCT02134275|Behavioral|Whole body vibration training|Each whole body vibration session will consist of a 20 min timed stand on the vibration platform where participants will stand with their knees in a slightly flexed position (120°) while the plate oscillates. The vibration frequency will be set at ranges between 20-40Hz and the amplitude set at 2mm displacement.
16103902|NCT02133976|Behavioral|cognitive therapy|
16103903|NCT02133976|Behavioral|mindfulness training|
16103863|NCT02134275|Behavioral|Control group|Participants in this group will be asked to not make any significant changes to their lifestyle behaviors, such as diet and exercise, for the duration of the study.
16103864|NCT02134262|Drug|Cyclophosphamide or Bendamustine|Cyclophosphamide [1.5 g/m^2 x 1 day Intravenous (IV)] or Bendamustine [120 mg/m^2 x 2 days Intravenous (IV)] is administered as Pre-treatment medication of CD19-CAR-T.
16103865|NCT02134262|Genetic|Dose Level -1|CD19-CAR-T [1 x 10^5 cells/kg x 1 day and 2 x 10^5 cells/kg x 1 day Intravenous (IV)] are administered.
16103866|NCT02134262|Genetic|Dose Level 1|CD19-CAR-T [1/3 x 10^6 cells/kg x 1 day and 2/3 x 10^6 cells/kg x 1 day Intravenous (IV)] are administered.
16103867|NCT02134262|Genetic|Dose Level 2|CD19-CAR-T [1 x 10^6 cells/kg x 1 day and 2 x 10^6 cells/kg x 1 day Intravenous (IV)] are administered.
16103868|NCT02134262|Genetic|Dose Level 3|CD19-CAR-T [1/3 x 10^7 cells/kg x 1 day and 2/3 x 10^7 cells/kg x 1 day Intravenous (IV)] are administered.
16103869|NCT02134249|Drug|Diosmin|2 tab / 8 hs Diosmin ( 500mg) will be given at day of HCG injection and for14 days
16103870|NCT02134249|Drug|Cabergoline|1 tab/day Cabergoline( 0.5 mg) will be given at day of HCG injection and for 8 days
16103871|NCT02134223|Behavioral|Dialectical behavior therapy|"in standard DBT, we will employ all treatment modalities: a weekly individual (1 hour) and group (2 hours) session, available telephone consultation, and DBT consultation team.
~DBT participants will be assigned to the next available individual therapist and relevant skills training group.
~Groups have a minimum of four members before commencement and a maximum of twelve members. Entry to the skills group occurs only at the commencement of the next skills module."
16103872|NCT02134223|Other|Treatment as Usual: any other drug or psychotherapy offered to participants, except DBT|
16103873|NCT02134210|Drug|Etanercept|Head-to-head comparison
16103874|NCT02134210|Drug|CHS-0214|
16103875|NCT02134197|Drug|Lupartumab Amadotin (BAY1129980)|Starting dose is 0.15mg/kg intravenous (I.V.) administration every 21 days.
16103877|NCT02134171|Other|Biological and imaging investigations|From day 1 to day 3, specific blood tests will be performed (serum troponin Ic and brain natriuretic peptide [BNP]). A cardiac ultrasonography within the 4 first days and a cerebral MRI within the first 7 days after TMA diagnosis will be performed.
16103878|NCT02134158|Device|anodal tDCS and sham tDCS stimulations|"Two conditions will be tested in randomized order: 2 arms in the first one anodal tDCS and then sham tDCS. In the other arm sham tDCS and then anodal tDCS.
~All the investigations will associate with clinical, functional and 3D motion analysis assessments."
16103879|NCT02134132|Biological|Platelet Gel|Application of platelet gel in patients suffering from diabetic foot ulcers.
16103880|NCT02134132|Other|Placebo|The patients with Diabetic foot ulcer who receive placebo instead of PL Gel.
16103881|NCT02134119|Dietary Supplement|Echinacea-based dietary supplement|Echinacea-based dietary supplement given at 8,000mg/day or 16,000 mg/day by mouth
16103882|NCT02134119|Drug|Placebo|Sugar pill manufactured to mimic dietary supplement
16103883|NCT02134106|Drug|Polymyxin B|Intravenous polymyxin B will be started on a standard dose of 25,000U/kg body weight, in 2 divided doses each day, infused over 2 hours. The duration of intravenous antibiotic treatment for subjects with either bacteremia or VAP or HAP will be at least 10 days. The duration of intravenous polymyxin B can be prolonged based on clinical indication, e.g., deep-seated source of infection, etc. For patients with VAP, nebulized colistin at the dose of 2 MU 8 hourly for 5 days will be prescribed.
16103884|NCT02134106|Drug|Polymyxin B + Doripenem|Standard dose of intravenous polymyxin B at 25,000U/kg body weight will be given in 2 divided doses each day with each dose infused over 2 hours and intravenous doripenem 500mg, with each dose infused over 4 hours. For patients with VAP, nebulized colistin at the dose of 2 MU 8 hourly for 5 days will be prescribed.
16103885|NCT02134093|Drug|Induction of anesthesia,midazolam ,sufentanil,etomidate and rocuronium|Anesthesia induction:midazolam (0.03~0.05 mg/kg), sufentanil(0. 5~0.8 μg/kg), etomidate ( 0.2~0.6mg/kg) and rocuronium(0.6mg/kg)
16103886|NCT02134093|Drug|Dexmedetomidine|Continuous pump infusion dexmedetomidine at 0.5μg/kg （low dose group）or 1μg/kg （high dose group）for 15 minutes before anesthesia induction，then followed by a continuous pump infusion at 0.2 μg/kg/h（low dose group）or 0.4μg/kg/h（high dose group） until the end of surgery.
16103887|NCT02134093|Drug|Normal saline|Continuous pump infusion normal saline with identical volume of dexmedetomidine.
16103888|NCT02134093|Drug|Maintenance of anesthesia , propofol, remifentanil,vecuronium|Continuous infusion of propofol （3~6 mg/kg/h）, remifentanil （0.05~0.3 μg/kg/min）is required to maintain Entropy within 40~60,Mean Arterial Blood Pressure more than 20% of baseline level , Oxygen Saturation more than 90% , airway pressure less than 40 cm H2O, intermittent injection vecuronium （0.05~0.1mg/kg） as needed to maintain muscle relaxation.
16103889|NCT02134080|Drug|PF-04457845|PF-04457845 will be administered orally at 4mg daily for four weeks.
16103890|NCT02134080|Drug|Placebo|Placebo will be administered orally at 4mg daily for four weeks.
16103891|NCT02134067|Drug|TAS-119|
16103892|NCT02134067|Drug|Paclitaxel|A dose of 90 mg/m2 is used in combination with various doses of TAS-119.
16103893|NCT02134041|Other|traumatic brain injury|mild TBI, GCS >/=13 after traumatic brain injury
16103894|NCT02134028|Drug|Dupilumab|Pharmaceutical form: Solution for injection Routes of administration: Subcutaneous
16103895|NCT02134015|Drug|Patritumab|Infusion of Patritumab (loading dose of 18 mg/kg, followed by 9 mg/kg every 3 weeks)
16103896|NCT02134015|Drug|Erlotinib|Oral erlotinib 150 mg/day
16103897|NCT02134015|Drug|Placebo|Placebo infusion every 3 weeks
16103898|NCT02134002|Drug|Disulfiram|Thirty cocaine dependant patients will be included in this study during their hospitalization for withdrawal. After the inclusion visit, they will be randomized to receive disulfiram 250 mg/day or placebo over the 15 days of their hospitalization.
16103899|NCT02134002|Drug|Placebo|Thirty cocaine dependant patients will be included in this study during their hospitalization for withdrawal. After the inclusion visit, they will be randomized to receive disulfiram 250 mg/day or placebo over the 15 days of their hospitalization.
16103900|NCT02133989|Drug|Ticlopidine + Ginko biloba|ticlopidine hydrochloride 250mg, ginko leaf ext. 80mg, twice daily
16103901|NCT02133989|Drug|Clopidogrel|clopidogrel bisulfate 97.875mg(75mg as clopidogrel)
16103906|NCT02133950|Procedure|elective cryopreservation of available embryos after PGD|no elective fresh embryo transfer; freeze all
16103907|NCT02133950|Procedure|PGD and elective fresh embryo transfer plus cryopreservation of supernumerary available embryos after PGD|PGD and elective fresh embryo transfer plus cryopreservation of supernumerary available embryos after PGD
16103908|NCT02133937|Drug|gantenerumab|Single subcutaneous injection of a high concentration liquid formulation
16103909|NCT02133937|Drug|gantenerumab|Single subcutaneous injection of a lyophilized formulation
16103912|NCT02133911|Drug|Ranolazine|
16103913|NCT02133898|Other|L-methylfolate|L-methylfolate, an FDA approved medical food will be administered in 15 mg capsule form once daily for 90 days
16103914|NCT02133885|Drug|Minocycline Group|These subjects will start with minocycline for 16 weeks, followed by a washout period for 3 weeks, then will receive a placebo for 16 weeks, followed by a washout period for 3 weeks, then will finish with minocycline for 16 weeks.
16103915|NCT02133885|Other|Placebo Group|These subjects will start with placebo (tablet looking just like minocycline) for 16 weeks, followed by a washout period for 3 weeks, then will receive minocycline for 16 weeks, followed by a washout period for 3 weeks, then will finish with placebo for 16 weeks.
16103916|NCT02133872|Drug|Minocycline dose escalation|Subjects will receive minocycline 50mg if no mean daytime ABPM SBP decline =/> 5mm Hg; subjects will receive minocycline 100mg, if no mean daytime ABPM SBP decline =/> 5mm Hg BP subjects will receive minocycline 200 mg.
16103917|NCT02133846|Drug|TPI 287 2 mg/m2|2 mg/m2 of TPI-287 diluted with 500mL 0.9% sodium chloride. TPI-287 is a microtubule inhibitor belonging to the taxane diterpenoid (taxoid) family, and specifically to the abeotaxane class.Drug: Placebo Drug: Placebo 500mL 0.9% sodium chloride.
16103918|NCT02133846|Drug|TPI-287 20 mg/m2|20 mg/m2 of TPI-287 diluted with 500mL 0.9% sodium chloride. TPI-287 is a microtubule inhibitor belonging to the taxane diterpenoid (taxoid) family, and specifically to the abeotaxane class
16103919|NCT02133846|Drug|Placebo|500mL 0.9% sodium chloride
16103920|NCT02133846|Drug|TPI-287 6.3 mg/m2|6.3 mg/m2 of TPI-287 diluted with 500mL 0.9% sodium chloride. TPI-287 is a microtubule inhibitor belonging to the taxane diterpenoid (taxoid) family, and specifically to the abeotaxane class
16103921|NCT02133833|Device|Quantum Spectrum Radiation Emitter|The patients receive stimulation treatment of Quantum Spectrum Radiation Emitter (5 quantum chips) daily for three weeks. The emitters are placed around the shoulder.
16103922|NCT02133820|Drug|4 mg 12 hourly capsule - strong pain killer fasted|
16103923|NCT02133820|Drug|4 mg 12 hourly capsule - strong pain killer fed|
16103924|NCT02133820|Drug|12 hourly capsule strong painkiller with antagonist fasted)|
16103925|NCT02133820|Drug|4 mg 12 hourly capsule strong painkiller with antagonist fed|
16103926|NCT02133807|Procedure|Specific Lp(a) apheresis|"Specific Lp(a) apheresis procedures were carried out weekly with Lp(a) Lipopak columns (POCARD Ltd., Moscow, Russia) according to the standard protocol"
16103927|NCT02133794|Device|Tomosynthesis|
16103928|NCT02133781|Biological|Fluzone® 2009-2010 Formula|This vaccine is given intramuscularly
16103929|NCT02133781|Biological|FluMist® 2009-2010 Formula|This vaccine is given intranasally
16103930|NCT02133755|Drug|Bromocriptine|Three month administration of bromocriptine. Baseline ultrasound and laboratory parameters measured. Repeat measures at discontinuation of drug at 3 months.
16103931|NCT02133742|Drug|Axitinib|Axitinib at starting dose of 5 mg and 3 mg BID.
16103932|NCT02133742|Drug|MK-3475|MK-3475 with two dose levels: 2 mg/kg every three weeks to find the maximum tolerated dose and continue treatment in a dose expansion phase.
16103933|NCT02133729|Other|Blood sampling and OGTT|
16103934|NCT02133716|Other|expressed breast milk|"The administration will be by direct instillation feeding syringe (maximum capacity 1ml) in the front of the mouth of the infant and accompanied throughout the administration of non-nutritive sucking (pacifier) and manual containing both sucrose treatment oral, as in the oral expressed breastmilk.
~A single dose prior to venipuncture of expressed breast milk given two minutes in the sequence and then will proceed to the venipuncture care nurse responsible for the child, accompanied at all times provided the technical permitted with non-nutritive sucking and containment."
16103935|NCT02133716|Behavioral|sucrose 24% oral|"The administration will be by direct instillation feeding syringe (maximum capacity 1ml) in the front of the mouth of the infant and accompanied throughout the administration of non-nutritive sucking (pacifier) and manual containing both sucrose treatment oral, as in the oral expressed breastmilk.
~A single dose prior to venipuncture of oral sucrose 24% given two minutes in the sequence and then will proceed to the venipuncture care nurse responsible for the child, accompanied at all times provided the technical permitted with non-nutritive sucking and containment."
16103936|NCT02133703|Behavioral|Enhanced Internet DA|BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support including a preference clarification tool. This intervention is designed to provide education and decision support regarding the available risk management options.
16103937|NCT02133703|Behavioral|Internet DA|BRCA1/2 carriers randomized to this arm will have access to Internet-based decision support. This intervention is designed to provide education regarding the available risk management options.
16103938|NCT02133703|Behavioral|Enhanced Print DA|BRCA1/2 carriers randomized to this arm will receive print-based decision support materials which include a preference clarification tool. This intervention is designed to provide education and decision support regarding the available risk management options.
16103939|NCT02133703|Behavioral|Print DA|BRCA1/2 carriers randomized to this arm will receive print education materials designed to provide information regarding the available risk management options.
16103940|NCT02133703|Behavioral|Inconclusive Results DA|Women who receive uninformative BRCA1/2 results randomized to this arm will have access to Internet-based decision support including a preference clarification tool. This intervention is designed to provide education and decision support regarding the available risk management options.
16103941|NCT02133690|Biological|Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV)|Live Attenuated Pentavalent (G1-G2-G3-G4-G9) Human X Bovine Reassortant Rotavirus Vaccine (BRV-PV), at a dosage of ≥ Log10^5.6 fluorescent focus units (FFU)/Serotype/Dose in 2.5 ml of buffered diluent
16103942|NCT02133690|Other|Placebo|Lyophilized minimal essential medium (MEM) + excipients reconstituted in 2.5 ml of buffered diluents
16103943|NCT02133677|Drug|temozolomide 100mg|WBRT: 30 Gy in 15 fractions (2 Gy per fraction, 5 fractions per week) CT: TMZ 200 mg p.o. q.d. x 5 days per week x 3 weeks
16103944|NCT02133664|Drug|lipoic acid and omega-3 fatty acids|alpha lipoic acid as racemic form at 1,200 mg per day omega-3 fatty acids as fish oil concentrate containing a daily dose of 1.35 grams docosahexanoic acid and 1.95 grams of eicosapentaenoic acid
16103945|NCT02133664|Drug|Placebo|placebo lipoic acid and placebo oil
16103946|NCT02133638|Drug|Sevoflurane|Induction of anesthesia: fentanyl 2 µg kg-1 and a bolus inhalation of 8% sevoflurane in an 8 L.min-1 fresh gas flow. Anesthesia maintenance: 1 minimal alveolar concentration (MAC) sevoflurane at a low fresh gas flow of 0.6-0.8 L min-1 in a 60% air-oxygen mixture supplemented with boluses of fentanyl.
16103947|NCT02133638|Drug|Propofol|Induction of anesthesia: propofol 2 mg kg-1 and fentanyl 4 µg kg-1. Maintenance of anesthesia: infusion of propofol 8 mg kg-1 h-1 and boluses of fentanyl 3 µg kg-1.
16103948|NCT02133625|Drug|carboplatin|
16103949|NCT02133625|Drug|pioglitazone|
16103950|NCT02133612|Drug|paclitaxel; cisplatin|The adjuvant chemotherapy regimen consisted of paclitaxel 150mg/m2 intravenously (IV) over 3 hours on day 1, followed by cisplatin 50mg/m2 IV on day 2 every 14 days for 4 to 6 cycles.
16103951|NCT02133599|Drug|IOHEXOL|Patients receive 5 mL of Iohexol prior to cycle 1 and 4 of HDMTX
16103952|NCT02133586|Other|Ozone|Exposure to 300ppb ozone with intermittent exercise as either the first exposure in a two-exposure series or as the second exposure approximately 22 hours after the first exposure (either clean air or nitrogen dioxide) in a two-exposure series.
16103953|NCT02133586|Other|Nitrogen dioxide|Exposure to 500ppb nitrogen dioxide with intermittent exercise as either the first exposure in a two-exposure series or as the second exposure approximately 22 hours after the first exposure (either clean air or ozone) in a two-exposure series.
16103954|NCT02133573|Drug|Progesterone|Crinone is supplied in a single use, disposable, white polypropylene vaginal applicator with a teal twist-off cap. Each applicator delivers 1.125 grams of Crinone gel containing 90 mg (8% gel) of progesterone in a base containing glycerin, mineral oil, polycarbophil, carbomer 934P, hydrogenated palm oil glyceride, sorbic acid, purified water and may contain sodium hydroxide. Crinone 8% is administered vaginally at a dose of 90 mg twice daily. The rounded tip of the applicator is inserted into the vagina. After insertion, the plunger is pushed to release the gel into the vagina. The applicator is removed.
16103955|NCT02133573|Drug|Vaginal lubricant|Replens Long-Lasting Moisturizer is supplied in pre-filled, sealed and individually wrapped applicators.Replens Long-Lasting Moisturizer will also be dosed at one applicator intravaginally twice daily.
16103956|NCT02133560|Behavioral|Video recording|Subjects will be asked to monitor their daily iron chelator administration by taking a video recording of preparing it and ingesting at least one sip. The data collected will be analyzed to describe patient adherence and comfort level with the process of daily recording of medication management.
16103957|NCT02133560|Behavioral|Medication Administration Log|Subjects will be asked to monitor their daily iron chelator administration by completing the medication administration log on a daily basis. The data collected will be analyzed to describe patient adherence and comfort level with the process of daily recording of medication management.
16103958|NCT02133560|Behavioral|Education|"During this first six months period a study staff member will see subjects at each scheduled clinic visit they attend for regular blood transfusion.
~Subjects will receive educational material and short quizzes related to sickle cell disease, thalassemia, iron overload, or iron chelation."
16103959|NCT02133534|Drug|Atorvastatin|
16103960|NCT02133521|Drug|DLBS1033|Investigational drug or placebo will be given in addition to the standard therapy, consists of: aspirin enteric-coated tablet 1 x 80 mg daily, simvastatin film-coated tablet 1 x 20 mg daily, and vitamin B complex 1 x 1 tablet
16103961|NCT02133521|Drug|Placebo|Investigational drug or placebo will be given in addition to the standard therapy, consists of: aspirin enteric-coated tablet 1 x 80 mg daily, simvastatin film-coated tablet 1 x 20 mg daily, and vitamin B complex 1 x 1 tablet
16103962|NCT02133495|Procedure|Non Cadaveric Human Acellular Dermal Tissue|
16103963|NCT02133482|Drug|Placebo|placebo solution
16103964|NCT02133482|Drug|BI 639667|oral solution BI 639667, single rising doses
16103965|NCT02133469|Biological|PCV7 (Pneumococcal 7-Valent Conjugate Vaccine)|injection 0.5 mL, single dose
16103966|NCT02133469|Biological|Hib Vaccine|Single Dose
16103967|NCT02133443|Device|PSV - pressure support ventilation|Gold standard partial ventilator support: Pressure Support Ventilation performed with Servo-i® ventilator (MAQUET,Critical Care, Sweden). Pressure support ventilator assistance to obtain a tidal volume of 6-8 ml/kg of ideal body weight.
16103968|NCT02133443|Device|Neurally Adjusted Ventilatory Assist|"Partial ventilator support partial ventilation mode (NAVA) performed with Servo-i® ventilator (Maquet,Critical Care, Sweden). Different levels of neurally adjusted ventilatory assist are tested. Stepwise implementation of the NAVA level (steps of 25% ), returning to the  optimal  level between each evaluation (PSV 100%, NAVA 100%, 75%, 50%, 125%, 150%)."
16103969|NCT02133430|Device|Bispectral index, as measured by a BIS processor|Comparisons of incidence of postoperative delirium.
16103970|NCT02133417|Device|Quantitative Transmission Ultrasound|Quantitative Transmission Ultrasound (QTUS) as an automated breast ultrasound procedure for women who have a mammographically detected mass.
16103971|NCT02133404|Drug|ASP7991|oral
16103972|NCT02133404|Drug|Cinacalcet|oral
16103973|NCT02133404|Drug|Placebo|oral
16103974|NCT02133391|Other|Centralized Reminder/Recall (R/R)|Method of increasing immunization delivery using reminder/recall techniques, which are implemented centrally.
16103975|NCT02133391|Other|Practice-based Reminder/Recall|Method of increasing immunization delivery using reminder/recall techniques, which are implemented at the practice level.
16103976|NCT02133378|Device|Hemopatch|Baxter Hemopatch
16103977|NCT02133378|Behavioral|Traditional Hemostasis Techniques (dry or wet gauze compression or similar)|
16103978|NCT02133365|Behavioral|Mindfulness and Interoceptive Exposure|The Mindfulness and Interoceptive Exposure intervention will be delivered in 4-5 manualized, individualized therapy sessions, of 1.5 hours - 2 hours each. The intervention is comprised of four established cognitive-behavioral strategies: psychoeducation, mindfulness, interoceptive exposure and skills generalization.
16103979|NCT02133352|Drug|Ranolazine|Single arm- ranolazine, initiated at 500 mg BID and increased to 1000 mg BID as tolerated
16103980|NCT02133339|Drug|TRN-157|
16103981|NCT02133339|Drug|Placebo|
16103982|NCT02133326|Drug|Caldolor|Subject will be given Caldolor by IV prior to surgery.
16103983|NCT02133326|Drug|Ofirmev|Subject will be given Ofirmev prior to surgery.
16103984|NCT02133300|Other|electrical stimulation|
16103985|NCT02133287|Device|AVI® Arsenic trioxide drug eluting stent delivery system|
16103986|NCT02133287|Device|Firebird2® sirolimus eluting stent system|
16103987|NCT02133274|Behavioral|Brief Psychosocial Intervention|Five weekly sessions of a Brief Psychosocial Intervention based of Behavioral Cognitive Therapy designed specifically for the present study.
16103988|NCT02133274|Other|Early Palliative Care|Early integration of Palliative Care into the standard oncologic care. Patients starting first line chemotherapy will receive immediately evaluation by the board-certified palliative care physicians.
16103989|NCT02133235|Procedure|conventional|insertion endobronchial blocker with the guidance of fiberoptic bronchoscopy
16103990|NCT02133235|Procedure|auscultation|insertion endobronchial blocker by auscultation, without the guidance of fiberoptic bronchoscopy
16103991|NCT02133222|Procedure|blood sample|
16103992|NCT02133209|Behavioral|Mindfulness Based Stress Reduction|Mindfulness Based Stress Reduction (MBSR) involves focused attention while practicing moment-to-moment nonjudgmental awareness of the self with the goal of achieving emotional balance and clarity of thought. There will be 8 weekly sessions and a half day retreat followed by 4 bi-weekly sessions over a period of 4 months.
16103993|NCT02133209|Behavioral|Stress Management for Headaches|Intervention involves a standardized stress management for headaches (SMH) group intervention that focuses on stress and general stress management skills, headache symptoms and their management, sleep hygiene, and healthy eating. There will be 8 weekly sessions followed by 4 bi-weekly sessions over a period of 4 months.
16103998|NCT02133183|Other|Laboratory Biomarker Analysis|Correlative studies
16103999|NCT02133183|Other|Pharmacological Study|Correlative studies
16104000|NCT02133183|Drug|Sapanisertib|Given PO
16104001|NCT02133183|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16104002|NCT02133170|Behavioral|Mindfulness Based Cognitive Therapy (MBCT)|The MBCT program is conducted in HULP (BRV and CBP), which also train therapists from Vitoria, in order to homogenize the intervention. Random sessions are video or audio recorded to be discussed and analyzed by the treatment team. The manualized MBCT therapy consists of 8 weekly sessions of 90 minutes and is applied in groups of approximately 10-15 patients. At least two programs in H. La Paz and two in the hospital de Santiago (Vitoria) will be provided.
16104003|NCT02133170|Behavioral|Psychoeducation|Psychoeducation program will be held in groups of 10 to 15 patients in 90-minute weekly sessions led by two therapists also outside the research team. The specific program of 8 sessions is focused addressing disease awareness, adherence to treatment and early detection of prodromal symptoms. Homework will also be included. The program is based on the Psychoeducation Manual for Bipolar Disorder . F.Colom , E.Vieta . Ars Medica, 2004. Attendance at least 80 % of the sessions of both interventions will be required to be considered complete.
16104004|NCT02133170|Behavioral|Standard treatment|Treatment as usual (TAU), including standard psychiatric care with psychopharmacological treatment.
16104005|NCT02133157|Drug|Sulfatinib|Sulfatinib is a capsule in the form of25, 50mg , 100mg; oral, once a day
16104006|NCT02133144|Behavioral|overeating fat|
16104007|NCT02133144|Behavioral|overeating carbohydrate|
16104008|NCT02133131|Drug|Grazoprevir/Elbasvir FDC|FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken q.d. by mouth.
16104009|NCT02133131|Drug|Sofosbuvir|Sofosbuvir 400mg tablet taken q.d. by mouth.
16104010|NCT02133118|Drug|individual SUs, insulin, pioglitazone|
16104011|NCT02133105|Drug|Levosimendan|
16104012|NCT02133105|Drug|Dobutamine|
16104013|NCT02133092|Other|No intervention|This is an observational study. The children hospitalized with lower respiratory tract infection (LRTI) with a laboratory confirmed RSV infection will be monitored for maximum 7 days or until hospital discharge.
16104014|NCT02133079|Biological|autologous gp96 vaccination|vaccination of autologous gp96 derived from tumor tissue + basal treatment
16104015|NCT02133066|Procedure|Bedside Ultrasound-Assisted Site Marking|Patient will receive a bedside ultrasound-assisted site marking of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap using Mindray M7 Ultrasound.
16104016|NCT02133066|Device|Mindray M7 Ultrasound|Patient will receive a bedside ultrasound exam of the most appropriate site for lumbar puncture prior to the clinician completing the spinal tap
16104017|NCT02133066|Procedure|Routine lumbar puncture|Lumbar puncture will be performed per routine standard of care
16104018|NCT02133053|Other|Medical Device, drug-like|Ectoin Allergy Nasal Spray
16104019|NCT02133053|Drug|Beclomethasone|Beclomethasone nasal spray
16104020|NCT02133027|Procedure|Rouviere's sulcus|Dissection may be started safely by division of the peritoneum immediately ventral to the sulcus and continued in a triangle bounded by the liver surface, the neck of the gallbladder and the plane of the sulcus.
16104021|NCT02133027|Device|surgical instruments|surgical instruments used in the laparoscopic cholecystectomy,such as ratcheted grasper,atraumatic grasper ,scissors.
16104022|NCT02133014|Procedure|laparoscopic-assisted percutaneous catheter drainage|Removing necrotic pancreatic organizations and putting the catheter around the region of pancreas.After the surgery,patient's cavity are continuously douched by catheter using 0.5% 5-fluorouracil normal saline
16104704|NCT02127970|Drug|Dalbavancin-matching Placebo|Dalbavancin-matching placebo IV infusion over 30 minutes.
16104023|NCT02133014|Drug|0.5% 5-fluorouracil normal saline|On the one hand,0.5% 5-fluorouracil normal saline directly inhibit DNA synthesis of pancreatic acinar cells which result in the synthesis of amylopsin of and trypsase is restrained.On the other hand,it can induce pancreatic cells apoptosis and alleviate pancreatic necrosis.
16104024|NCT02133001|Drug|Esketamine|Esketamine 84 mg will be self-administered by participants as intranasal spray as two times a week, for 4 weeks (that is, Day 1,4,8,11,15,18,22,25). Dose may be reduced to 56 mg per day based on Investigator's discretion.
16104025|NCT02133001|Drug|Placebo|Matching placebo will be self-administered by participants as intranasal spray as two times a week, for 4 weeks (that is, Day 1,4,8,11,15,18,22,25).
16104026|NCT02132988|Biological|OPT-822/OPT-821|
16104027|NCT02132975|Device|Biopsies using Apollo and UroStation®|Apollo : Motorised probe handler for prostate biopsies
16104028|NCT02132975|Procedure|Biopsies using UroStation® (image fusion)|
16104029|NCT02132962|Dietary Supplement|Amino acid infusion|
16104030|NCT02132962|Other|Bloodsamples, Biopsies.|
16104031|NCT02132949|Drug|5-Fluorouracil|Participants will receive 5-fluorouracil 500 mg/m^2 IV on Day 1 of each cycle q3w.
16104032|NCT02132949|Drug|Cyclophosphamide|Participants will receive cyclophosphamide 600 milligrams per square meter (mg/m^2) intravenous (IV) given on Day 1 of each cycle q2w.
16104033|NCT02132949|Drug|Docetaxel|Participants will receive docetaxel at a starting dose of 75 mg/m^2 IV for the first cycle and the dose may be escalated to 100 mg/m^2 for subsequent cycles q3w.
16104034|NCT02132949|Drug|Doxorubicin|Participants will receive doxorubicin 60 mg/m^2 IV on Day 1 of each cycle q2w.
16104035|NCT02132949|Drug|Epirubicin|Participants will receive epirubicin 100 mg/m^2 IV on Day 1 of each cycle q3w.
16104036|NCT02132949|Drug|Paclitaxel|Participants will receive paclitaxel 80 mg/m^2 IV given weekly.
16104037|NCT02132949|Drug|Pertuzumab|Participants will receive pertuzumab at a loading dose of 840 milligrams (mg) IV loading dose, then 420 mg IV q3w.
16104038|NCT02132949|Drug|Trastuzumab|Participants will receive trastuzumab at a loading dose of 8 milligrams per kilogram (mg/kg) IV, then 6 mg/kg IV q3w.
16104039|NCT02132936|Drug|LEO 90100 aerosol foam|
16104040|NCT02132936|Drug|Aerosol foam vehicle|
16104041|NCT02132936|Drug|Calcipotriol BDP gel|
16104042|NCT02132936|Drug|Gel vehicle|
16104043|NCT02132923|Biological|No intervention|This is an observational study. The children hospitalized with lower respiratory tract infection (LRTI) with a laboratory confirmed RSV infection will be monitored for maximum 7 days or until hospital discharge.
16104044|NCT02132910|Other|RESTORE Intervention|
16104045|NCT02132897|Drug|Auration CR Tablets 400 Single Dose-Tegretol CR 400 Single Dose|Carbamazepine CR Tablets 400 milligrams is given orally with 250 mL of water at room temperature.
16104046|NCT02132897|Drug|Tegretol CR 400 Single Dose-Auration CR 400 Single Dose|Auration CR 400 milligrams Single Dose is given orally with 250 mL of water at room temperature.
16104047|NCT02132884|Other|cytology specimen collection procedure|Undergo collection of tissue and blood samples
16104048|NCT02132884|Procedure|therapeutic procedure|Receive standard of care treatment
16104049|NCT02132884|Drug|targeted therapy|Receive specific targeted therapy
16104050|NCT02132884|Other|laboratory biomarker analysis|Correlative studies
16104051|NCT02132871|Device|Impedance cardiography Physioflow ®|
16104052|NCT02132858|Other|cytology specimen collection procedure|Correlative studies
16104053|NCT02132858|Other|laboratory biomarker analysis|Correlative studies
16104054|NCT02132845|Other|cytology specimen collection procedure|Undergo collection of tissue and blood samples
16104055|NCT02132845|Drug|targeted therapy|Receive target-directed therapy
16104056|NCT02132845|Procedure|therapeutic procedure|Receive standard of care therapy
16104057|NCT02132845|Other|laboratory biomarker analysis|Correlative studies
16104058|NCT02132832|Drug|Buspirone|Buspirone is an anxiolytic compound marked by modulation of both 5-HT1A and D3 receptors. Buspirone is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks. 10 mg buspirone is administered on days 1-4, then the dose is increased by 10 mg every 3 days to a maximum of 40 mg buspirone on days 10-19.
16104059|NCT02132832|Drug|Placebo|Placebo is administered orally twice per day (9:00 AM and 6:00 PM) for 3 weeks.
16104060|NCT02132819|Other|Withholding feeds|At least 2 feeds before the transfusion, 2 feeds after the transfusion and feeds during the transfusion are withholded
16104061|NCT02132819|Other|feeding during transfusion|The feeding process will be continued during the transfusion
16104062|NCT02132806|Procedure|Piezosurgery with biomaterial mp3 + bracket|
16104063|NCT02132806|Procedure|Piezosurgery with biomaterial mp3|
16104064|NCT02132806|Procedure|Piezosurgery|
16104065|NCT02132793|Behavioral|Anger Management Therapy|Anger Management Therapy (AMT) is a 12-session manual-driven cognitive-behavioral intervention found efficacious for anger management treatment.
16104066|NCT02132793|Behavioral|Anger Management Therapy & RELAX app|Anger Management Therapy (AMT) is a 12-session manual-driven cognitive-behavioral intervention found efficacious for anger management treatment. RELAX app (1) enables the practice of anger management strategies remotely through mobile phone interfaces; (2) integrates with evidence-based treatments through implementing an existing CBT anger management course; (3) provides information, direction, and feedback through physiological sensors; and (4) supports communication and direction by the therapist through a web-based therapist interface and a remote and secure patient data server.
16104067|NCT02132767|Drug|Amiodarone|"Amiodarone Initial Dose
~Oral: 400 mg po TID for 3 days is recommended
~For patients incapable of taking oral: 150 mg IV bolus over 10 min, then 1 mg/min over 6 hours followed by 0.5 mg/min over 18 hours Maintenance Dose
~Oral: at least 200 mg/day to be continued until 60 days after randomization
~If drug cannot be given orally or via NG tube: 0.5 mg/min administered through central line (e.g., PICC) until oral dosing is started"
16104068|NCT02132767|Procedure|DC-cardioversion|DC-Cardioversion - frequency and duration determined by medical professional as medically needed
16104069|NCT02132767|Drug|Rate Control|Beta-blocker and/or Calcium channel blockers and/or Digoxin - Dose, frequency and duration determined by medical professional as medically needed
16104070|NCT02132754|Biological|MK-4166|
16104071|NCT02132754|Biological|Pembrolizumab|
16105572|NCT02121483|Drug|empagliflozin low dose|
16104072|NCT02132728|Other|Flaxseed or rice raw powder ingestion|The experimental groups received isocaloric diets and different proportions of carbohydrates, and the introduction of 60g of brown flaxseed or rice raw powder. Flaxseed and raw rice were crushed weekly by minimal particle type mill and appropriate sieves for fine grinding grain with a degree to 250 mm/micrometers. After crushing flaxseed and raw rice, they were weighed in semi-analytical balance. The addition of flaxseed or raw rice powder was made in the collation (40 g added to milk) and lunch (20 g added to baked beans). The volunteers received flaxseed or rice raw powder, portioned to be used for 42 days, including the weekends.
16104073|NCT02132715|Behavioral|Resistance Exercise|
16104074|NCT02132715|Behavioral|KAATSU exercise|
16104075|NCT02132702|Device|Ekso|
16104076|NCT02132689|Drug|Actilyse (Thrombolytic therapy)|
16104077|NCT02132689|Drug|Heparine (Standard anticoagulation therapy)|
16104078|NCT02132663|Other|Control: Marketed routine infant formula|
16104079|NCT02132663|Other|An investigational infant formula containing an alternate source of DHA|
16104080|NCT02132650|Behavioral|ACC training|Rehabilitation of walking using accurate (ACC) walking tasks, such as stepping on targets, over obstacles, etc.
16104081|NCT02132650|Behavioral|SS training|Rehabilitation of walking using typical steady state (SS) walking. Conducted overground and on treadmill. 36 sessions of training conducted over the course of 12 weeks. Each session lasts about 1 hour.
16104082|NCT02132637|Drug|Insulin Peglispro|Administered SQ
16104083|NCT02132637|Drug|Insulin Glargine|Administered SQ
16104084|NCT02132624|Biological|Autologous 3rd generation CD19-targeting CAR T cells|Autologous CD19-targeting CAR T cells with three signaling domains derived from CD3zeta, CD28 and 4-1BB.
16104085|NCT02132611|Device|Diamondback 360® Coronary OAS Micro Crown|The Diamondback 360® Coronary OAS Micro Crown consists of a diamond-coated crown mounted to a shaft. The OAD ablates occlusive material in order to facilitate stent delivery. During orbit, forces press the crown against the coronary plaque, reducing calcified plaque on the vessel wall.
16104086|NCT02132598|Drug|cabozantinib|
16104087|NCT02132585|Procedure|Speckle tracking echocardiography|
16104088|NCT02132572|Device|BIOCELL™ Textured 410 Implant|Previously received a Natrelle BIOCELL™ textured 410 implant for primary breast augmentation.
16104089|NCT02132559|Drug|DHEA|
16104090|NCT02132546|Drug|Chlorhexidine|
16104091|NCT02132533|Drug|Nifedipine|Nifedipine 20 mg orally, then nifedipine 20 mg orally after 90 minutes if still contracting. Continue nifedipine 20 mg orally every 4 hours after the first dose for 48 hours.
16104092|NCT02132533|Drug|Placebo|Placebo orally, then placebo orally after 90 minutes if still contracting. Continue placebo orally every 4 hours after the first dose for 48 hours.
16104093|NCT02132533|Other|Usual care|Usual evaluation, monitoring and care for women with preterm labor.
16104094|NCT02132520|Device|rTMS|Low frequency rTMS (either real or sham) will be applied to the contralesional hemisphere at a rate of 1Hz for 10 minutes.
16104095|NCT02132520|Behavioral|BCI Training|BCI training will consist of a series of EEG-based motor-imagery tasks with virtual feedback presented on a computer screen.
16104096|NCT02132494|Behavioral|Physical activity|
16104097|NCT02132481|Other|EMA Only|The EMA only condition consists of: a) RSAU, b) an Android phone, c) a 6-hour EMA training on how to use the phone, HIV and SUD prevention, self-monitoring, procedures for completing the EMAs (see Appendix), d) an EMA signaling schedule covering 6 EMA prompts over a 16-hour time period per day tailored to each participant's schedule, e) research office visits twice a week during 1st month for staff to check participant's proficiency using the phone and completing EMAs, and f) collecting urine screens.
16104098|NCT02132481|Other|EMI Only|The EMI only condition includes: a) RSAU, b) an Android phone, c) a 6-hour EMI training on how to use the phone, HIV and SUD prevention, how each EMI relates to relapse prevention or HIV risk reduction, and how to access each EMI, d) research office visits twice weekly in 1st month as described above except visits focus on EMIs, and e) collecting urine screens.
16104099|NCT02132481|Other|EMA+EMI|"The combined condition includes: a) RSAU, b) an Android phone, c) the 6-hour EMA training, d) EMA signaling schedule, e) the 6-hour EMI training, f) research office visits 2 times a week during 1st month, and g) feedback following each EMA, which will include participants' current risk of use in the next 7 days ."
16104100|NCT02132481|Other|Neither - RSAU|"The neither smartphone condition will still have access to community recovery support as usual (RSAU). Standard discharge practice is to provide a recovery plan and relevant referrals. A recent RCT indicated that after leaving treatment, 37% of the clients attended self-help in the community, 41% participated in substance-free structured activities, and about 14% returned to treatment within 6 months. They will also participate in office visits twice a week during 1st month to complete non-phone related surveys and provide urine for screens."
16104101|NCT02132468|Drug|fosbretabulin tromethamine|60 mg/m2, IV on Day 1, 8 and 15 of a 3-week cycle; 3 cycles or until progression or unacceptable toxicity
16104102|NCT02132455|Procedure|colonoscopy|colonoscopy (colon examination with flexible tube and a camera) is to find early precancerous growth in the colon (polyps) and remove them before they turn into cancer
16104103|NCT02132442|Dietary Supplement|Ergocalciferol, placebo|Ergocalciferol 50000 IU capsules Microcrystalline cellulose
16104104|NCT02132429|Drug|AMG 333|Oral administration available in varying dose strength.
16104105|NCT02132429|Drug|Placebo|Placebo containing no active drug
16104106|NCT02132416|Drug|NSAID|Will be used if tolerated.
16104107|NCT02132416|Drug|Opioids|Initially intravenous administration and when tolerated oral slow-release pils will be used.
16104108|NCT02132416|Drug|Thoracic Epidural anaesthesia|Given by specialists in anaesthesiology and intensive care.
16104109|NCT02132416|Drug|Paracetamol|1g QID will be given to all patients unless allergies.
16104110|NCT02132416|Procedure|Surgical management|Fracture stabilization
16104111|NCT02132403|Drug|BTH1704|BTH1704 at assigned doses administered on days 1, 8, 15, and 22 of a 28-day (4 week) cycle.
16104112|NCT02132403|Drug|IMPRIME PGG|Imprime PGG at assigned doses administered on days 1, 8, 15, and 22 of a 28-day (4 week) cycle.
16104113|NCT02132403|Drug|Gemcitabine|Gemcitabine on days 1, 8, and 15, at assigned doses, of a 28-day (4 week) cycle.
16104114|NCT02132390|Drug|Goserelin|
16104115|NCT02132390|Drug|Toremifene|
16106499|NCT02114775|Drug|Sildenafil|50 mg by mouth daily
16104116|NCT02132364|Other|optimised follow-up|optimised follow-up will be done by nursing personnel associated with a caregiving member of his social circle.
16104117|NCT02132338|Behavioral|The Education Health Program|The operation of the educational program for the group under intervention will consist of groups operating with the triad of diabetes mellitus (pathophysiology of the disease, physical activity and diet), to be held in five times (cycles) approach, an interval of three months being held between them . In each session, participants will be the same (under multidisciplinary team intervention), the content will also be the same, however, using different educational strategies. During the intervals between cycles these users will be monitored by phone by equity and / or nursing students of the Federal University of São João Del Rei properly trained to do so. The educational program will be developed in five times (T0, T3, T6, T9, T12) and with an interval of three months. At every moment the educational process will be conducted with three consecutive meetings with one week interval. In summary, 15 educational sessions with the experimental group will be held.
16104118|NCT02132325|Behavioral|Dignity Therapy|Dignity Therapy/Life Plan will be provided by an advanced practice nurse or chaplain (APN/Chap), who has undergone training in provision of Dignity Therapy (offered through a 3-day group workshop by Dr. Harvey Chochinov).
16104119|NCT02132312|Drug|OMS302|
16104120|NCT02132312|Drug|Phenylephrine HCl|
16104121|NCT02132299|Biological|PfSPZ Vaccine|Aseptic, purified, vialed, metabolically active, non-replicating (live, radiation attenuated) cryopreserved Plasmodium falciparum sporozoites (PfSPZ)
16104122|NCT02132299|Biological|Normal Saline (Placebo)|
16104123|NCT02132299|Biological|PfSPZ Challenge|Live, infectious, aseptic, purified, vialed, cryopreserved Plasmodium falciparum sporozoites (PfSPZ) for CHMI
16104124|NCT02132286|Drug|Quetiapine XR (extended release)|Treatment of quetiapine XR ( extended release)in MDD patients with S/Lg alleles
16104125|NCT02132273|Other|Educational Story|Educational story with pictures illustrating overnight polysomnography procedure accompanied by simple narrative.
16104126|NCT02132260|Drug|Naftifine Hydrochloride Cream 2%|Naftifine Hydrochloride Cream 2% (Taro Pharmaceuticals Inc.) applied once-daily for two weeks
16104127|NCT02132260|Drug|Naftin® (Naftifine Hydrochloride) Cream 2%|Naftin® (Naftifine Hydrochloride) Cream 2% (Merz Pharmaceuticals, LLC) applied once-daily for two weeks.
16104128|NCT02132260|Drug|Placebo Topical Cream|Placebo Topical Cream (Taro Pharmaceuticals Inc.) applied once-daily for two weeks.
16104129|NCT02132247|Drug|Diclofenac hydroxyethylpyrrolidine|
16104130|NCT02132234|Drug|Etanercept|biological treatment according to rheumatologic indication
16104131|NCT02132234|Drug|Adalimumab|biological treatment according to rheumatologic indication
16104132|NCT02132234|Drug|Certolizumab|biological treatment according to rheumatologic indication
16104133|NCT02132234|Drug|Infliximab|biological treatment according to rheumatologic indication
16104134|NCT02132221|Behavioral|Cognitive Behavioral Therapy|10- weekly 1h30 group sessions including psychoeducation and group discussions on pain, pain coping, opioid mechanisms, and relationship between mood, sleep, stress and pain.
16104135|NCT02132195|Drug|ACTH|Patients will receive ACTH twice weekly for 6 months, with a 50% dose reduction allowed for side effects. The dose will be reduce by 50% at 6 months and continued for an additional 6 months.
16104136|NCT02132182|Biological|Blood draw|The patient population for this study will be comprised of individuals who present to clinic with newly diagnosed osteosarcoma with or without infection and without known metastasis to the lung. These patients would have a standard-of-care blood draw. For the study we will be drawing an additional 15-20mL of blood (no additional needle stick).
16104137|NCT02132169|Drug|Drug: AC-170 0.24%|
16104138|NCT02132169|Drug|AC-170 0%|
16104139|NCT02132143|Radiation|intensity-modulated radiation|For concurrent chemoradiotherapy, the intensity-modulated radiation therapy(IMRT)will be given at the first day of therapy,total dose of 5000cGy～6000cGy/5-6 Weeks.
16104140|NCT02132143|Radiation|intensity-modulated radiation|For sequential chemoradiotherapy,the intensity-modulated radiation will(IMRT) will be given when patients received adjuvant chemotherapy for four cycles,total dose of 5000cGy～6000cGy/5-6 Weeks.
16104141|NCT02132130|Drug|CGF166|CGF166 is a recombinant adenovirus 5 (Ad5) vector containing the human Atonal transcription factor (Hath1) cDNA for administration via intra-labyrinthine infusion
16104142|NCT02132117|Drug|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 29 days.
16104143|NCT02132117|Drug|Vehicle to Oxymetazoline HCL Cream|Vehicle to Oxymetazoline HCL Cream (AGN-199201) applied to the face once daily for 29 days.
16104144|NCT02132104|Procedure|Uterine application of amnion membrane|Uterine application of amnion membrane following hysteroscopic adhesiolysis.
16104145|NCT02132104|Device|Foley balloon|Uterine application of Foley balloon
16104146|NCT02132104|Drug|Femoston|Hormones treatment after surgery.
16104147|NCT02132091|Other|Intermittent Fasting|The intermittent fasting paradigm used in this study will require participants to alternate between days of feasting (175% of normal caloric intake) and fasting ( 25% of normal caloric intake). Food will be provided by University of Florida Clinical Research Center with macronutrient composition prepared according to the 2010 Dietary Guidelines for Americans.
16104148|NCT02132091|Dietary Supplement|400 IU Vitamin E|once each day in morning; oral pill form
16104149|NCT02132091|Dietary Supplement|1000 mg Vitamin C|500mg twice each day; morning and evening; oral pill form
16104150|NCT02132065|Drug|TAP block|Patients will be scheduled to receive routine analgesic and an unilaterally dual TAP block with 2 points injections of 15 ml of 0,375 % Ropivacain( in total 30 ml 0,375% Ropivacain) in the same side of nephrectomy.
16104151|NCT02132039|Other|12-step sitting Tai Chi Chuan|The intervention consists of eight home-based sessions on 12-step sitting Tai Chi Chuan. Each session will last for an hour.
16104152|NCT02132039|Other|Control|The control consists of eight home-based sessions on useful health-care information. Each session will last for an hour.
16104153|NCT02132026|Drug|Denosumab|
16104154|NCT02132026|Drug|Alendronic Acid|
16104155|NCT02132026|Drug|Denosumab Placebo|subcutaneous injection of 0.9%Saline at baseline, 6 months, 12 months and 18 months
16104156|NCT02132026|Drug|Alendronic Acid Placebo|Inert Capsule containing lactose monohydrate manufactured and labelled by Investigational Supplies Group (ISG) University of Edinburgh.
16104157|NCT02132013|Behavioral|Intervention SUBLIME|Intervention: dietary sodium restriction supported by 2 group meetings, structured self-regulation computer program, e-coaching.
16104158|NCT02132000|Drug|toremifene or tamoxifen|
16104159|NCT02131961|Drug|Collagenase ointment|250 collagenase units/g
16104160|NCT02131961|Device|Modified Contact Cast System|1 Unit
16104161|NCT02131948|Drug|Intranasal insulin|Intranasal spray
16104162|NCT02131948|Drug|Intranasal placebo|Intranasal spray
16104163|NCT02131922|Procedure|Intensive Treatment|Intensive Surgical Treatment of Periodontitis
16104164|NCT02131922|Procedure|Dental Hygienization Treatment|
16104165|NCT02131922|Drug|Chlorhexidine (Intensive Treatment)|Chlorhexidine (PerioKIN) (0.2%) implantation in dental pockets
16104166|NCT02131909|Procedure|mirror therapy|During a session, the child performs a series of 10 single, bilateral and synchronous movements while viewing the reflected image
16104167|NCT02131909|Procedure|bimanual rehabilitation exercises|During a session, the child performs a series of 10 single, bilateral and synchronous movements while watching his two hands
16104168|NCT02131896|Other|Interventional arm-Mediterranean diet|
16104169|NCT02131896|Other|Control Arm- regular nutritional instructions in accordance with the accepted nutritional guidelines|
16104170|NCT02131883|Behavioral|Group-Cognitive Behavioral Therapy|psychoeducation, stress management, cognitive restructuring, response prevention, exposure, relapse prevention
16104171|NCT02131883|Other|Wait-List with treatment as usual|Intervention typical supportive talks from general practitioner. No restrictions for interventions for patients here.
16104172|NCT02131870|Dietary Supplement|L plantarum DSM 9843 or placebo|
16104173|NCT02131857|Behavioral|active interventional program based on Mindfulness training|active interventional program based on Mindfulness training
16104174|NCT02131844|Other|Facilitated early mobilization|Participants randomized to this group, in addition the preoperative education (usual care), will have early mobilization facilitated by a trained health professional. This health professional will: (1) visit the participant on the day of surgery to reinforce mobilization goals and assist with transfer to a chair and (2) visit the participant three times per day starting from POD 1 to reinforce mobilization goals and walk with the participant (at least the length of the hallway). Targeted walking distances will increase according to the participant's tolerance. This intervention will be undertaken until POD 3 or hospital discharge, whichever comes first.
16104175|NCT02131844|Other|Usual care|Participants randomized to this group will receive instructions about postoperative mobilization in a preoperative education session and will receive a booklet describing mobilization goals for each POD (sit in a chair for 2 hours on the day of surgery, stay out of bed for at least 6 hours/day from POD 1 until hospital discharge)
16104176|NCT02131818|Drug|Amoxicillin|The patient will be received amoxicillin 500 mg 2 capsules orally bid pc for 5 days
16104177|NCT02131818|Drug|Placebo|The patient will be received placebo 2 capsules orally bid pc for 5 days
16104178|NCT02131805|Radiation|Electronic Skin Surface Brachytherapy|
16104179|NCT02131805|Behavioral|Quality of life assessment|
16104180|NCT02131792|Procedure|Slanted recession of the lateral rectus muscle|All patients who had intermittent exotropia with convergence weakness was enrolled to the slanted lateral rectus muscle recession group.
16104181|NCT02131779|Behavioral|Men's Workshops|Two male Community Health Advisors will be trained using traditional/classroom methods and provided with technical assistance/support to implement the 4 part workshop series.
16104182|NCT02131779|Behavioral|Co-Educational Workshops|One male and one female Community Health Advisor will be trained using traditional/classroom methods and provided with technical assistance/support to implement the 4 part workshop series. Two break out sessions will occur in the Health Partner condition with separate discussion sessions for men and female health partners.
16104183|NCT02131766|Device|DiAs|DiAs is the central component of our system. It is a standard cell phone running on an Android operating system. The cell phone has been changed to prevent from (1) using it as a phone or browser, (2) changing the volume (3) accidentally shutting it off. The cell phone runs an algorithm and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range and help avoid hypoglycemia during the night.
16104184|NCT02131766|Other|Sensor Augmented Pump Therapy|Insulin pump plus CGM.
16104185|NCT02131753|Drug|Cladribine s.c. injection, HCL treatment|Patients with hairy cell leukemia and the need for treatment are given cladribine 0.14 mg/kg for 5 consecutive days as a s. c bolus injection
16104186|NCT02131740|Other|Eye rubbing|eye rubbing for 1 minute in horizontal direction clockwise, 5 second rest & eye rubbing for a further 1 minute.
16104187|NCT02131740|Other|No eye rubbing|This eye will not be rubbed
16104188|NCT02131727|Behavioral|Hand Hygiene Improvement Intervention|Participants received a 4 minute video about protective hand hygiene behaviors and other activities (cough ettiquette, and staying home when ill) to reduce the risk of contracting respiratory tract and GI infections. In addition, motivational posters and hand hygiene supplies were distributed in the work setting.
16104189|NCT02131727|Behavioral|Ask Me 3|"Participants in the control group received a 4 minute training video about the Ask Me 3 program to promote effective communication with health care providers, along with an Ask Me 3 brochure and a key-chain with the Ask Me 3 principles for effective communication with health care providers."
16104190|NCT02131714|Behavioral|counseling and exercises|These individuals were asked about parafunctional habits and the treatment was applied by providing an explanation concerning the role of pain, possible aetiological factors of the patient's TMD, the relationship between chronic pain and psychosocial distress, and its benign character. They also had to perform once daily application of hot packs on both sides of the face for 20 minutes and after that they must perform active free therapeutic exercise of mouth opening for 10 times
16104191|NCT02131714|Behavioral|lifestyle counseling|
16104192|NCT02131701|Behavioral|Physical activity|
16104193|NCT02131688|Drug|Mitoxantrone Hydrochloride Liposome|
16104194|NCT02131675|Dietary Supplement|Boost shake|Blood draw after mixed-meal consumption
16104195|NCT02131662|Drug|BAY1002670|Subjects received 4 milligram (mg) Vilaprisan (VPR) tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
16105358|NCT02123082|Device|Storz single Lumen Ureteroscope|Single lumen, flexible scope for ureteroscopies
16104196|NCT02131662|Drug|BAY1002670|Subjects received 2 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
16104197|NCT02131662|Drug|BAY1002670|Subjects received 1 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
16104198|NCT02131662|Drug|BAY1002670|Subjects received 0.5 mg VPR tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
16104199|NCT02131662|Drug|Placebo|Subjects received matching placebo tablet once daily orally for 12 weeks (84 days) from the first week of the menstrual cycle following randomization.
16104200|NCT02131649|Device|18F-FCH PET/MRI Scan|Patients will first undergo screening to ensure eligibility. If eligible, they will undergo a PET/MRI scan using 18F-FCH as the radiolabeled tracer. If prostate cancer is detected outside the prostate, patients may undergo a biopsy or follow-up 18F-FCH PET/MRI to confirm the results.
16104201|NCT02131636|Drug|AGN-199201|AGN-199201 applied to the face once daily for 29 days.
16104202|NCT02131636|Drug|Vehicle to AGN-199201|Vehicle to AGN-199201 applied to the face once daily for 29 days.
16104203|NCT02131597|Drug|Guadecitabine|Given SC
16104206|NCT02131558|Procedure|ICG Dye|ICG Dye injections
16104207|NCT02131545|Drug|Quetiapine 25 mg gel applied topically|Quetiapine 25 mg gel applied topically; 9 serum quetiapine levels drawn over the course of 8 hours
16104208|NCT02131545|Drug|Quetiapine 25 mg tablet by mouth|Quetiapine 25 mg tablet administered by mouth; 9 serum quetiapine levels drawn over the course of 8 hours
16104209|NCT02131545|Drug|Quetiapine 25 mg rectal suppository|Quetiapine 25 mg suppository administered rectally; 9 serum quetiapine levels drawn over the course of 8 hours
16104210|NCT02131545|Drug|Quetiapine 25 mg gel applied topically|Quetiapine 75 mg gel applied topically every 4 hours for 24 hours; 6 serum quetiapine levels drawn over the course of 24 hours
16104211|NCT02131532|Behavioral|A brief psychological intervention|This intervention is based on the principle of cognitive-behavioral therapy
16104212|NCT02131519|Procedure|internal jugular vein catheter placement|
16104213|NCT02131506|Drug|Lapatinib, Caelyx|Lapatinib, Caelix: Lapatinib is given at escalating doses orally and continuously on days 1-21. Caelyx is administered at escalating doses in a 60-minute i.v. infusion on day 1. Each cycle is defined as 21 days. Four dose levels are planned. Dose level -1, Caelyx 30 mg/mq & Lapatinib 1000 mg die; dose level 1, Caelyx 30 mg/mq & Lapatinib 1250 mg die; dose level 2, Caelyx 30 mg/mq & Lapatinib 1500 mg die; dose level 3, Caelyx 40 mg/mq & Lapatinib 1500 mg die
16104214|NCT02131493|Drug|S-1, Gemcitabine|
16104215|NCT02131480|Drug|Doxorubicin|60 mg/m²
16104216|NCT02131480|Drug|Trabectedin|1,1 mg/m²
16104217|NCT02131467|Drug|Perampanel|oral drug
16104218|NCT02131454|Other|Inhalation technique training|Training in inhalation technique in asthmatics and COPD patients
16104219|NCT02131441|Procedure|laparoscopic hepatectomy|
16104220|NCT02131441|Procedure|open liver resection|
16104221|NCT02131402|Device|ocufilcon D|Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (ocufilcon D) in the contra lateral eye.
16104222|NCT02131402|Device|omafilcon A|Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (omafilcon A) in the contra lateral eye.
16104223|NCT02131402|Device|methafilcon A|Contralateral pair of study lenses. Test lens (enfilcon A) in one eye and a control lens (methafilcon A) in the contra lateral eye.
16104224|NCT02131389|Device|Iconacy Hip System|
16104225|NCT02131376|Procedure|Non-renorrhaphy|The suture closure of the renal cortex after tumor removal is omitted. A base layer running stitch only is performed for hemostasis and urine leak prevention.
16104226|NCT02131376|Procedure|Renorrhaphy|After tumor resection the patient will have both a deep and cortical layer reconstruction
16104227|NCT02131363|Device|Ingrowing Toenail Treatment Kit|detailed in arm description
16104228|NCT02131350|Procedure|Photocoagulation|Photocoagulation include focal/grid laser and/or panretinal photocoagulation
16104229|NCT02131350|Drug|Ranibizumab|
16104230|NCT02131337|Other|Electrophysiology study|after 3 months to check for pulmonary vein isolation (PVI) status
16104231|NCT02131324|Drug|DFD06 Cream|
16104232|NCT02131324|Drug|Clobetasol Propionate Cream 0.05%|
16104233|NCT02131311|Device|disposable, single-use pessary|
16104234|NCT02131298|Drug|Palbociclib Alone|A single 125 mg dose of palbociclib free base capsule given orally alone in the fed state, followed by 120 hours of PK sample collection
16104235|NCT02131298|Drug|Palbociclib plus itraconazole|Itraconazole 200 mg once daily with food for a total of 11 days; on Day 5, a single oral 125 mg dose of palbociclib will be given with itraconazole after a meal, followed by 168 hours of PK sample collection.
16104236|NCT02131285|Other|Sensory training|
16104237|NCT02131272|Drug|Insulin detemir|Administered subcutaneously (s.c., under the skin) once or twice daily. The subjects' pre-trial OAD's i.e. metformin treatment should continue unchanged during the treatment period.
16104238|NCT02131272|Drug|Insulin NPH|Administered subcutaneously (s.c., under the skin) once or twice daily. The subjects' pre-trial OADs i.e. metformin treatment should continue unchanged during the treatment period.
16104239|NCT02131272|Behavioral|Diet/exercise|Intervention will be performed through family based changes in eating and activity behaviours.
16104240|NCT02131259|Drug|Afatinib dimaleate|20mg - 50mg
16104241|NCT02131246|Drug|Faster-acting insulin aspart|Subjects will receive a single dose of either Faster-acting insulin aspart or NovoRapid® at a predefined fixed dose level in connection to intake of a standardised meal. Administered subcutaneously (s.c., under the skin)
16104242|NCT02131246|Drug|insulin aspart|Subjects will receive a single dose of either Faster-acting insulin aspart or NovoRapid® at a predefined fixed dose level in connection to intake of a standardised meal. Administered subcutaneously (s.c., under the skin)
16104243|NCT02131233|Drug|Reformulated Raltegravir|Reformulated raltegravir 1200 mg (2x 600 mg tablets) orally once daily
16104244|NCT02131233|Drug|Raltegravir|Raltegravir 400 mg tablet orally twice daily
16104836|NCT02126813|Procedure|Current used interventional threshold for urinary bladder catheterization (500 ml)|
16104245|NCT02131233|Drug|TRUVADA™|Emtricitabine / tenofovir disoproxil fumarate 200 / 300 mg tablet administered once-daily with food (open-label)
16104246|NCT02131233|Drug|Placebo to Reformulated Raltegravir|Placebo to reformulated raltegravir 2 tablets orally once daily
16104247|NCT02131233|Drug|Placebo to Raltegravir|Placebo to raltegravir 1 tablet orally twice daily
16104248|NCT02131220|Drug|Prourokinase|20mg intracoronary bolus infusion using selective catheter during PCI
16104249|NCT02131220|Drug|Tirofiban|10ug/kg intracoronary bolus infusion using selective catheter during PCI
16104250|NCT02131220|Drug|normal saline|intracoronary bolus infusion using selective catheter during PCI
16104251|NCT02131207|Device|magnetic resonance imaging|Undergo pelvic MRI
16104252|NCT02131207|Procedure|prostate biopsy|Undergo prostate biopsy
16104253|NCT02131194|Dietary Supplement|Lenstatin|Dietary Supplement Lenstatin
16104254|NCT02131194|Drug|Placebo|Placebo sugar pill manufactured to mimic Lenstatin
16104255|NCT02131155|Drug|Placebo|Once daily
16104256|NCT02131155|Drug|Afatinib|Once daily
16104257|NCT02131142|Device|BioFreedom drug coated coronary stent|Placement of a BioFreedom drug coated stent in a narrow coronary artery
16104258|NCT02131129|Device|rTMS|"The stimulation sites will be the left and right DLPFC, defined as 5 cm anterior to the scalp positions at which the MTs were determined. Treatments will be delivered within the following stimulation parameters: 110% of MT, 20 Hz, 30 trains, 1.0 second per train, 20 pulses per train, inter-train interval of 30 seconds (600 pulses/hemisphere, for a total of 1200 pulses/session/day).
~Ten sessions over a two week duration"
16104259|NCT02131129|Device|Sham Comparator|"The stimulation sites will be the left and right DLPFC, defined as 5 cm anterior to the scalp positions at which the MTs were determined. Treatments will be delivered within the following stimulation parameters: 110% of MT, 20 Hz, 30 trains, 1.0 second per train, 20 pulses per train, inter-train interval of 30 seconds (600 pulses/hemisphere, for a total of 1200 pulses/session/day).
~Ten sessions over a two week duration"
16104260|NCT02131116|Behavioral|Integrated Metacognitive Therapy|Integrated Metacognitive Therapy
16104261|NCT02131116|Behavioral|Treatment as Usual|Treatment as Usual
16104262|NCT02131103|Other|Percutaneous coronary intervention|"All patients received fibrinolysis, aspirin 300 mg and clopidogrel (300 mg for participants 75 years of age or younger or 75 mg for participants older than 75 years of age). Patients older than 75 years of age did not receive enoxaparin.
~Patients will be randomly assigned to either the group that received routine early PCI (hereinafter termed the early-PCI group) or the group that received standard treatment (PCI performed after 24-72 hours of successfully fibrinolysis). Randomized will perform within 24 hours after successful fibrinolytic therapy. PCI will be performed when persistent occlusion or substantial stenosis of the infarct-related artery (either stenosis of 70% or more of the diameter of the artery or stenosis of 50-70% with thrombus, ulceration, or spontaneous dissection) was present. In case of multivessel disease, only culprit lesion will be correct."
16104263|NCT02131090|Device|Tegaderm TM|This is a generic adhesive dressing which is commonly used to secure epidural catheters.
16104264|NCT02131090|Device|Lock-it Plus|This dressing is specifically designed for securing epidural catheters. It is adhesive to the patient's back and has a plastic clamp through which the epidural catheter passes. Once closed, the clamp secures the catheter.
16104265|NCT02131090|Device|Epifix|This dressing is specifically designed to secure epidural catheters. It is adhesive to the patient's back and has a foam, moulded mechanism through which the catheter is passed. An adhesive flap folds over the whole mechanism to secure the catheter.
16104266|NCT02131077|Biological|ALLO-ASC-TI|
16104267|NCT02131077|Drug|Placebo|
16104268|NCT02131064|Drug|Carboplatin|Carboplatin IV infusion at a dose to achieve an AUC of 6 mg*min/mL q3w
16104269|NCT02131064|Drug|Docetaxel|Docetaxel 75 mg/m^2 IV infusion q3w
16104270|NCT02131064|Drug|Pertuzumab|Pertuzumab 840 mg (loading dose); and 420 mg (maintenance dose) IV infusion q3w
16104271|NCT02131064|Drug|Trastuzumab|Trastuzumab 8 mg/kg (loading dose); and 6 mg/kg (maintenance dose) IV infusion q3w
16104272|NCT02131064|Drug|Trastuzumab Emtansine|Trastuzumab Emtansine 3.6 mg/kg IV infusion q3w
16104273|NCT02131038|Other|Medica device, drug-like|Ectoin (R) Allergy Nasal Spray
16104274|NCT02131012|Drug|Intravitreal Celecoxib|1-4 mg intravitreal celecoxib
16104275|NCT02130999|Drug|tasimelteon 20 mg capsule|
16104276|NCT02130999|Drug|tasimelteon 2 mg I.V.|
16104277|NCT02130986|Other|Procalcitonin level|A procalcitonin (PCT) will be drawn level within one hour after randomization in the ED, and if hospitalized, 6-24 hours after the initial ED blood draw, and on Days 3, 5, and 7. Days 3, 5, and 7 blood draws for procalcitonin will only occur in hospitalized patients on antibiotics and/or at the treating physician's discretion.
16104278|NCT02130986|Other|Results of procalcitonin (PCT) level to treating clinician|In the ED, we will quickly (<1 hour goal) provide clinicians the procalcitonin result.
16104279|NCT02130986|Other|Provide procalcitonin guideline to treating clinician|"Procalcitonin antibiotic guideline --
~Procalcitonin level (ug/L) -- Bacterial etiology -- Recommendation
~< 0.1 -- Very unlikely -- Antibiotics strongly discouraged(1)
~0.1 - 0.25 -- Unlikely -- Antibiotics discouraged(1)
~> 0.25 - 0.5 -- Likely -- Antibiotics recommended(2)
~> 0.5 -- Very likely -- Antibiotics strongly recommended(2)
~Initial antibiotics can be considered for critical illness, Legionella pneumophilia. Procalcitonin should be evaluated in context with all findings and the total clinical status; clinical judgment always necessary.
~For outpatients, antibiotic duration based on level (> 0.25-0.5 ug/L:3 days; > 0.5-1.0 ug/L:5 days; >1.0 ug/L:7 days). Physician follow-up is recommended."
16104280|NCT02130986|Other|Telephone Visit|We will collect the number of antibiotic days during telephone visits occurring on or around Day 15 and Day 30
16104281|NCT02130973|Drug|Standard Clinical Practice Regimen|Standard Clinical Practice Regimen
16104282|NCT02130973|Drug|Experimental Cyclic Regimen|Experimental Cyclic Regimen
16104283|NCT02130947|Behavioral|Exercise|
16104284|NCT02130934|Procedure|Cardiac 3D MRI|
16104313|NCT02130817|Drug|Thymoglobulin (ATG)|Thymoglobulin (ATG) Induction. Thymoglobulin will be administered to a total cumulative dose of 4.5-6 mg/kg via a peripheral or central vein, starting in the operating room.
16104314|NCT02130817|Drug|Myfortic|Patients will receive 720mg bid of Myfortic throughout the study, starting day 1 after surgery.
16104837|NCT02126813|Device|Intermittent bladder catheter|
16104285|NCT02130921|Behavioral|Intervention to Address Drug Use and HIV in Vietnam|"Intervention for CHWs: 3 sessions will cover the understanding stigma and its impact, self-protection and universal precaution adherence, effective communication with patients and family members, and motivational enhancement for behavioral change.
~Intervention for IDUs: CHWs who participate in the intervention will be required to conduct 3 individual sessions with participating IDUs covering the following topics: physical health, risk reduction behaviors, mental health, and community integration.
~Intervention for FMs: CHWs who participate in the intervention will be required to conduct 2 group sessions with participating FMs covering the following topics: healthy family routine, coping with caregiver burdens, enhance family relationships, support positive behavior change."
16104286|NCT02130908|Other|Lean fish|Participants consumed 150g of lean fish, five times per week for 4 weeks
16104287|NCT02130908|Other|Fatty fish|Participants consumed 150g of fatty fish, five times per week for 4 weeks
16104288|NCT02130908|Other|Lean meat|Participants consumed 150g of lean meat, five times per week for 4 weeks
16104289|NCT02130895|Other|STOPP Criteria Decision Support Content|"55 previously developed clinical decision support suggestions based on the STOPP criteria will be activated in the physician EMR. Each suggestion provides a patient specific rule that, if triggered will display its title in an existing Clinical Decision Alerts box on the bottom right hand column in the patient's EMR chart. For example, in a patient with diabetes and on a beta blocker then the suggestion Consider: avoiding b-blockers in elderly diabetics with >=1 hypoglycaemic episodes / month will be presented to the physician in the side bar (not a popup). The physician then can decide to review, consider, or ignore the recommendation."
16104290|NCT02130882|Drug|benralizumab|An afucosylated humanized antibody to IL-5 receptor alpha
16104291|NCT02130882|Other|Placebo|A sterile solution containing 20 mM histidine/histidine-HCl, 0.25 M trehalose dihydrate, and 0.006% (w/v) polysorbate 20, pH 6.0, in saline
16104292|NCT02130869|Biological|CD133+ selected autologous stem cell infusion|Hematopoietic stem cells will be collected from children with high-risk solid tumors. After collection, they will be immuno-magnetically selected using CD133 as a marker in efforts to reduce tumor cell contamination in the stem cell graft. After high dose chemotherapy, those selected stem cells will be infused, followed shortly thereafter by an infusion of haploidentical natural killer cells.
16104293|NCT02130869|Biological|IL-2|Following infusion of haploidentical natural killer cells, interleukin-2 (IL-2) subcutaneously (SQ) will be given to support the in vivo survival of donor NK cells.
16104294|NCT02130869|Biological|hu14.18K322A|Participants with neuroblastoma (Group A) will receive hu14.18K322A intravenously (IV).
16104295|NCT02130869|Drug|Busulfan|Given IV - Group A only.
16104296|NCT02130869|Drug|Melphalan|Given IV - All groups.
16104297|NCT02130869|Biological|GM-CSF|Given SQ - All groups.
16104298|NCT02130869|Drug|Bendamustine|Given IV - Group B only.
16104299|NCT02130869|Drug|Etoposide|Given IV - Group B and Group C. In case of etoposide reactions, etoposide phosphate will be given.
16104300|NCT02130869|Drug|Cytarabine|Given IV - Group B only.
16104301|NCT02130869|Drug|Carboplatin|Given IV - Group C only.
16104302|NCT02130869|Device|Haploidentical natural killer cell infusion|NK cell product will be collected from donors using leukapheresis procedures. The autologous hematopoietic stem cell graft product will be positively selected using the investigational CliniMACS device and CD133 Microbead reagent. Following standard laboratory procedures, the NK cell product will be enumerated and assessed for viable cell content. NK cells will be infused by slow IV push over 3 to 15 minutes immediately after processing, evaluation and release testing.
16104303|NCT02130869|Biological|G-CSF|Given SQ - All Groups.
16104304|NCT02130869|Drug|Etoposide phosphate|In case of etoposide reactions, etoposide phosphate will be given IV. - Group B and Group C only.
16104305|NCT02130869|Device|CliniMACS|The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells.
16104306|NCT02130856|Device|Neonatal kit|"Contents of the neonatal kit:
~Clean birth kit: sterile blade, a clean plastic square, plastic gloves, hand soap, and cord ties/clamp.
~4% Chlorhexidine (CHX) lotion (15 mL) and a bag of cotton balls.
~Sunflower oil emollient (50 mL)
~ThermoSpot
~Mylar infant sleeve
~Click to heat warmer (http://www.heatinaclick.ca/products/pocket_size.html) in a fitted cloth pouch.
~Handheld electric scale with suspended cloth sling. The scale will not be included with the kit but rather one will be issued to each Lady Health Worker."
16104307|NCT02130843|Device|INSERTION OF URETEHRL CATHETER|USE OF A TIEMANN CATHETER TO INSERT THE URODYNAMIC STUDY CATHETER INTO THE BLADDER
16104308|NCT02130830|Drug|Topical 2,5% lidocaine + 2,5% prilocaine gel|The topical gel is administered in the anal canal at the moment of the anoscopy
16104309|NCT02130830|Drug|Placebo|Placebo gel to mimic topical anesthesia administered in the anal canal at the moment of the anoscopy
16104310|NCT02130817|Drug|Belatacept|Belatacept will be added to the standard of care regimen and will be given at days 0,5, weeks 2, 4, 8 and 12 (10 mg/kg) and every 4 weeks (5 mg/kg) for one year.
16104311|NCT02130817|Drug|Tacrolimus withdrawal|Tacrolimus dosing will begin on Days 1 through 5 post transplant at up to 2 mg BID to achieve target trough levels of 9-11 ng/ml. The dose will be tapered through the end of week 2 to achieve a trough level of 4 ng/ml which will be maintained for six weeks. Tacrolimus will be withdrawn at the end of eight weeks post transplant.
16104312|NCT02130817|Procedure|Plasmapheresis/Intravenous Immunoglobulin G|Enrolled patients will start with standard of practice treatment including plasmapheresis and IVIG therapy twice after transplant, on days 2 and 4 and potentially once before transplant. Plasmapheresis and albumin exchange for one volume of blood will be performed in the infusion center at the University of Wisconsin Hospital and Clinics (UWHC). Each pheresis session will be completed by IVIG infusion. While plasmapheresis will help with the removal of circulating Donor Specific Antibodies (DSA), IVIG therapy will provide immunomodulatory characteristics that include sterilizing immunity from infections, inhibiting and scavenging activated complement fragments, modifying cell-mediated immune responses, inducing regulatory T cells and importantly, inhibiting deleterious antibody production.
16104431|NCT02129803|Device|High-Flow, 20 LPM (via Optiflow cannula)|Nasal high flow humidification (20LPM) therapy will be administered using Optiflow with Airvo 2.
16104315|NCT02130817|Drug|Steroids|Patients will receive Dexamethasone IV on the day of surgery (Day 0) with tapered doses through Day 4 followed by prednisone tapered to 10mg/d by day 30.,
16104316|NCT02130804|Drug|Salsalate (4 g/day)|Given orally twice daily
16104317|NCT02130804|Drug|Placebo (4 g/day)|Given orally twice daily
16104318|NCT02130791|Behavioral|Sleep|
16104319|NCT02130778|Drug|Synthetic GLP-1 (1.5 pmol/kg/min) dissolved in 500 ml 0.9% saline|infusion of synthetic GLP-1 (1.5 pmol/kg/min) saline
16104320|NCT02130778|Other|500 ml 0.9% saline|infusion of saline
16104321|NCT02130765|Device|Cardiac catheter ablation with ICD/CRT-D|Cardiac ablation catheter system
16104322|NCT02130752|Device|Monopolar electrocautery|During the procedures of the abdominal approach D2 distal gastrectomy, use the monopolar electrocautery (Device) to coagulation and cut off blood vessel, separate and dissection lymph-nodes .
16104323|NCT02130752|Device|Ultrasonic scalpel|During the procedures of the abdominal approach D2 distal gastrectomy, use ultrasonic scalpel (Device) to coagulation and cut off blood vessel, separate and dissection lymph-nodes
16104324|NCT02130739|Procedure|thoracic epidural anesthesia|thoracic epidural anesthesia following continuous thoracic epidural analgesia for mastectomy
16104325|NCT02130739|Procedure|mastectomy|mastectomy with/without breast reconstruction
16104326|NCT02130739|Drug|Ropivacaine|Thoracic epidural anesthesia performed using 0.375% or 0.5% ropivacaine
16104327|NCT02130739|Drug|Propofol|Thoracic epidural anesthesia performed followed by sedation consisting of propofol
16104328|NCT02130739|Drug|Fentanyl|thoracic epidural analgesia continued; supplemented by a continuous epidural infusion of ropivacaine 0.15%, 2 ml/h with fentanyl 8mcg/h.
16104329|NCT02130726|Procedure|Minimally-invasive gastrectomy|Patients allocated to the 'Minimally-invasive gastrectomy' arm will receive total gastrectomy via laparoscopy.
16104330|NCT02130726|Procedure|Open Gastrectomy|patients allocated to the 'Open gastrectomy' group will receive total gastrectomy via laparotomy
16104331|NCT02130713|Drug|Third generation fluoroquinolone|Prulifloxacin 600 mg
16104332|NCT02130713|Dietary Supplement|Nutritional supplement + third generation fluoroquinolone|Serenoa repens 320 mg, Lactobacillus Sporogens 200 mg, Arbutin 100 mg and prulifloxacin 600 mg
16104333|NCT02130700|Drug|VT-464: given orally twice daily in 28-day cycles|Oral VT-464 given twice daily, in continuous 28-day cycles at the recommended Phase 2 dose
16104334|NCT02130700|Drug|VT-464: given orally once daily in 28-day cycles|Oral VT-464 given once daily, in continuous 28-day cycles at the recommended Phase 2 dose
16104335|NCT02130687|Drug|Placebo|"Subjects will receive two capsules of placebo to preserve the blinding of the study.
~In a separate period, subjects will receive one capsule of placebo and one capsule of sitagliptin."
16104336|NCT02130687|Drug|Sitagliptin|Subjects will receive sitagliptin 100mg daily for 7 days. In addition, subjects will receive either aprepitant or a capsule of placebo to preserve the blinding of the study.
16104337|NCT02130687|Drug|Aprepitant|Subjects will receive aprepitant (125 mg on the first day followed by 80mg/d) for 7 days along with sitagliptin.
16104338|NCT02130687|Other|Mixed Meal Test (MMT)|The first 18 subjects per arm/ group will undergo a mixed meal test on the 7th day of each medication intervention. This will take place after the first half of the study day at the clinical research center, following a 30 minute rest. Subjects will ingest a shake (combination of fixed carbohydrates/ fat/ protein) and have blood pressure, heart rate, and venous blood sample measurements collected for 4 hours after the meal.
16104339|NCT02130674|Drug|Dipeptiven|two groups: group 1: continuous infusion for 24 hours group 2: continuous infusion for 5 days
16104340|NCT02130661|Drug|Rilapladib 25 mg|White, round, biconvex, film coated tablet of 25 mg. Taken orally along with food.
16104341|NCT02130661|Drug|Rilapladib 250 mg|White, round, biconvex, film coated tablet of 250 mg. Taken orally along with food.
16104342|NCT02130661|Drug|Itraconazole|100 mg capsule with a blue opaque cap and pink transparent body. Taken orally along with food.
16104343|NCT02130648|Other|A sampling of blood|A sampling of blood de 14 ml
16104344|NCT02130635|Drug|GSK2269557 100 MCG|100 mcg of GSK2269557 blended with lactose per blister administered using a dry powder inhaler device
16104345|NCT02130635|Drug|GSK2269557 500 MCG|500 mcg of GSK2269557 blended with lactose per blister administered using a dry powder inhaler device
16104346|NCT02130635|Drug|PLACEBO|Lactose administered using a matching dry powder inhaler device
16104347|NCT02130622|Drug|Promethazine|
16104348|NCT02130622|Drug|Sugar pill|
16104349|NCT02130609|Device|Skintel|
16104350|NCT02130596|Behavioral|Acceptance-Based Behavioral Intervention|
16104351|NCT02130596|Other|Nutritional Counselling|
16104352|NCT02130583|Behavioral|Positive Affect Skills Training|Individual sessions (3-4) delivered on the inpatient unit, focused on psycho-education regarding positive affect and mood monitoring and teaching of skills to attend to positive affect such as mindfulness, gratitude, and savoring. In-person sessions are followed by weekly phone calls and daily text messages for one month, with option to extend.
16104353|NCT02130583|Behavioral|Treatment as Usual|Participants will follow the intervention plan laid out in their discharge summary, but do not receive any individual sessions regarding positive affect. Upon discharge, they will receive generic text messages regarding healthy habits for one month, with option to extend.
16104354|NCT02130570|Other|Multi-Model Intensive Discharge Intervention|"Inpatient medication safety interventions
~Inpatient discharge advocate
~Structured visiting nurse (VNA) appointments
~Post-discharge phone call by primary care personnel within 2 business days of discharge
~Structured post-discharge clinic appointment with PCP and other PCMH personnel within 2 weeks of discharge
~Improved communication between inpatient and primary care teams
~High-risk patients will receive additional interventions as needed:
~Home pharmacist visit
~Enrollment in the Partners integrated Care Management Program (iCMP)
~Enrollment in telemedicine programs for patients with CHF
~Palliative care consultation regarding goals of care
~Novel health information technology to facilitate communication and transfer of clinical information"
16104432|NCT02129803|Device|Low FLow, 5 LPM (via Optiflow cannula)|standard humidified wall medical air.
16104633|NCT02128464|Procedure|Standard knee cutting guides|Standard cutting guides use traditional instrumentation to determine knee implant positions. During surgery, a rod is placed in the leg bone and the cutting guide is attached to that rod.
16104355|NCT02130557|Drug|Bosutinib|Bosutinib (Bosulif®) is an orally bioavailable, potent, multi-targeted, dual Src-Abl tyrosine kinase inhibitor (TKI) that has been approved for the treatment of adult patients with Philadelphia positive (Ph+) chronic phase (CP), accelerated phase (AP) and blast phase (BP) chronic myelogenous leukemia (CML) previously treated with other TKI inhibitor therapy.[1] This study will investigate the use of bosutinib as first-line treatment for patients with Ph+ CP CML.
16104356|NCT02130557|Drug|Imatinib|"Imatinib mesylate (referred to in this protocol as imatinib) is an inhibitor of the BCR-ABL kinase and been the standard first-line therapy for patients with chronic-phase CML. Imatinib was granted approval by the European Commission in November 2001 and by the FDA in December 2002 for the treatment of newly diagnosed patients with CP Ph+ CML based on results from the IRIS trial.
~Imatinib is considered the standard of care for both first-line and later line settings, and consequently is an appropriate active comparator."
16104357|NCT02130531|Drug|Emixustat HCl Tablet|Tablet for oral administration
16104358|NCT02130531|Other|Placebo Tablet|Tablet for oral administration
16104359|NCT02130518|Drug|Auriclosene Irrigation Solution, 0.2%|
16104360|NCT02130518|Drug|Auriclosene Vehicle Solution|
16104361|NCT02130505|Dietary Supplement|OGTT|Oral glucose tolerance test (OGTT) with 75 g of oral anhydrous glucose
16104362|NCT02130492|Radiation|FDG|The intervention arm consists of treatment with increasing doses of [18F]-Fluorodeoxyglucose.
16104363|NCT02130479|Behavioral|Contingency Management-Family Engagement|
16104364|NCT02130479|Behavioral|Treatment as Usual|
16104365|NCT02130466|Biological|Pembrolizumab|IV infusion
16104366|NCT02130466|Drug|Dabrafenib|oral capsule
16104367|NCT02130466|Drug|Trametinib|oral tablet
16104368|NCT02130466|Drug|Placebo|IV infusion
16104369|NCT02130453|Drug|Regadenoson|0.4 mg by vein given during nuclear stress testing with echocardiography strain measurements.
16104370|NCT02130440|Drug|Resveratrol nasal spray|
16104371|NCT02130427|Diagnostic Test|CT scan|Weekly 3D/4D CT scan
16104372|NCT02130414|Drug|Sandimmun® IV|2 mg/kg IV
16104373|NCT02130414|Drug|CyCol® capsules|37.5 mg CyCol® capsules
16104374|NCT02130401|Device|TNM (thermoneuromodulation device)|The device is worn like a music headset and the patient lies on a wedge pillow while the device is active. Each session lasts under 20 minutes.
16104375|NCT02130388|Dietary Supplement|Zinc|
16104376|NCT02130375|Procedure|the IncontiLaseTM procedure|Utilizing laser (IncontiLaseTM) to treat the anterior vaginal wall area to intensify periurethral tissue and achieve urinary continence
16104377|NCT02130336|Behavioral|Aerobic interval training|
16104378|NCT02130336|Behavioral|Continuous moderate-intensity exercise|
16104379|NCT02130323|Drug|Imiquimod|12.5mg (5%) once a week vaginally for 16 weeks
16104380|NCT02130323|Procedure|Loop Electrosurgical Excision Procedure|Patients with CIN 2-3 will be randomized to receive intervention, CKC or LEEP versus medical therapy with Imiquimod.
16104381|NCT02130310|Biological|CureXcell®|CureXcell® is a cell based therapy obtained from donated whole blood. The blood is collected from healthy young adults, the white blood cells are separated and then activated by hypo-osmotic shock.
16104382|NCT02130310|Other|Placebo injection|Normal saline injected at each centimeter of ulcer bed
16104383|NCT02130297|Device|Laser Treatment|The subject will receive ablative fractional resurfacing with the Deep and Active FXTM platforms of the Lumenis Ultrapulse CO2 laser. The settings for treatment of scars on the face with the Deep platform will be 15% coverage, 15mJ at 150 Hz and 15% coverage, 12.5 mJ at 150 Hz for off the face. The Active platform settings will be 90 mJ with a density of 3 for the face and 70 mJ and a density of 2 for off the face. The DeepFXTM platform will be applied to the scar prior to the ActiveFX TM platform. Half of the excision scar will be treated with the appropriate settings and half will go untreated.
16104384|NCT02130284|Device|Predictive Low Glucose Management Feature in Insulin pump|All subjects will undergo hypoglycemic induction at Visit 2 with target set to 65 mg/dL using the rate of change basal increase algorithm. Low Limit setting when PLGM ON is 65 mg/dL.
16104385|NCT02130271|Drug|Radioactive dye|The radioactive dye [11C]PBR28 will be administered through an intravenous line (IV).
16104386|NCT02130271|Radiation|PET/MRI|All subjects will undergo a simultaneous PET/MRI scan. The scan will be up to 2 hours long.
16104387|NCT02130271|Other|Blood draw|Up to 11 tablespoons of blood will be drawn through an intravenous line (IV-line) for two purposes: 1) testing for the subject's genetic affinity to the radioactive dye, and 2) testing for the presence inflammatory biomarkers.
16104388|NCT02130258|Device|Quantitative Sensory Testing (QST)|Subjects will undergo hot and cold temperature testing using the QST device at two points: 1) Before ESI and 2) after ESI.
16104389|NCT02130258|Procedure|Epidural Steroid Injection (ESI)|Subjects will receive an ESI by their clinical physician as part of their clinical treatment. This procedure is not given as part of the research study.
16104390|NCT02130245|Procedure|Early cholecystectomy|Early laparoscopic cholecystectomy for acute cholecystitis after admission
16104391|NCT02130245|Procedure|Delayed cholecystectomy|Laparoscopic cholecystectomy well be done after a period on conservation
16104392|NCT02130232|Behavioral|Lifestyle Intervention|
16104393|NCT02130232|Other|Usual Care|
16104394|NCT02130219|Device|Non-invasive intracranial pressure measurement|The noninvasive ICP measurement device Vittamed 205 aICP meter used in this study has been developed in Lithuania. The method is based on two-depth transcranial Doppler technique for simultaneously measuring flow velocity pulsatilities in the intracranial and extracranial segments of the ophthalmic artery (OA). These measurements are made while applying a series of small pressure steps to the tissues surrounding the eye-ball. The intracranial segment of the OA is compressed by ICP and the extracranial segment of the OA is compressed by the externally applied pressure Pe. Blood flow pulsatility parameters in both of these OA segments are monitored.Pulsatilities are approximately the same when Pe = ICP. Two-depth TCD device is used as an indicator of the pressure balance point.
16104395|NCT02130219|Device|Brain MRI/CT|"1.5 T MRI using T1 and T2 regimes, brain MRI angiography, performed for selected patients to analyze anatomical features of ophthalmic artery and optical nerves sheath diameter.
~Brain CT performed to evaluate hemorrhage and stroke volume."
16104533|NCT02129166|Drug|Dasatinib|In this group, subjects will take dasatinib only. Dose regimen: dasatinib 20 mg single oral dose
16104396|NCT02130219|Procedure|Lumbar puncture and cerebrospinal fluid pressure measurement|Lumbar puncture performed in lateral decubitus position while knees and head flexed. After local antiseptics and anesthesia puncture in lumbar 3/4 or 4/5 intervertebral space performed. As CSF appears legs and head are relaxed and slightly straightened. Spinal manometer graded 0-40 cm H₂O with stopcock connected to the needle. CSF pressure monitored for 10 minutes and recorded. CSF collected for diagnostic test. Spinal needle Number 22 and Rocket Spinal Manometer Set (No. R55990) used for this study.
16104397|NCT02130206|Other|Caries Free|Gums will be examined. On some visits Saliva and plaque will be collected. Toothpaste assigned will include DenClude 1.5% Arginine.
16104398|NCT02130206|Other|Caries Active|Gums will be examined. On some visits Saliva and plaque will be collected. Toothpaste assigned will include DenClude 1.5% Arginine.
16104399|NCT02130206|Other|Caries Free - Placebo|Gums will be examined. On some visits Saliva and plaque will be collected. Marketed Toothpaste will be assigned.
16104400|NCT02130206|Other|Caries Active - Placebo|Gums will be examined. On some visits Saliva and plaque will be collected. Marketed Toothpaste will be assigned.
16104401|NCT02130193|Drug|Danirixin|Danirixin is available as 50 or 75 mg white, film coated immediate release tablet.
16104402|NCT02130193|Drug|Placebo|Subjects will receive danirixin matching placebo
16104403|NCT02130167|Drug|Atropine|Compare different concentrations of atropine eye drops (0.01% vs 0.05%) in the efficacy of controlling myopia progression and side effects of atropine
16104404|NCT02130154|Other|18-FDG PET CT scan and 123I-MIBG SPECT scan|
16104405|NCT02130141|Dietary Supplement|Dark chocolate|Mildly hypertensive subject will replace their usual snacks with with 50 g dark chocolate daily for a period of 8 weeks.
16104406|NCT02130141|Other|Dietary counselling|Usual snacks are limited.
16104407|NCT02130128|Device|LungPoint ATV System|The LungPoint ATV System is an image-guided navigation system used to access tissue samples in the lungs.
16104408|NCT02130115|Device|LungPoint ATV System|The LungPoint ATV System is an image-guided navigation system used to access tissue samples in the lungs.
16104409|NCT02130102|Device|The ModuLAAr Ambient Assisted Living System|"The system consists of the following modules which will be provided to the volunteers according to their needs:
~tablet computer (digital photo album, video telephone, meal ordering system, reminder system), bodyweight scale, blood pressure meter, emergency call system, mobile phone (documentation of personal health-related data), bathroom surveillance system, blood glucose meter, house automation technologies/smart home technologies"
16104410|NCT02130089|Behavioral|Intensive Tailored Education|
16104411|NCT02130063|Drug|iron isomaltoside 1000 (Monofer®)|
16104412|NCT02130063|Drug|iron sucrose (Venofer®)|
16104413|NCT02130037|Behavioral|application|along standard psychotharpy we use a smartphone application that allows the patient to monitor her meals, behaviours, emotions and thoughts and to communicate them directly in real time to their therapists.
16104414|NCT02130037|Other|psychotherapy|standard psychotherapy for eating disorders
16104415|NCT02130024|Drug|Ranibizumab 0.5 mg|Administered as an intravitreal injection
16104416|NCT02130024|Drug|Aflibercept 2.0 mg|Administered as an intravitreal injection
16104417|NCT02130011|Other|with feeding/fluid instruction|No additional intervention besides standard treatment prescription will be added. Investigators foresee daily kV cone beam CT matching (already standard in house). this subgroup of 10 patients will be asked not to eat or drink carbonated fluids three hours before CT simulation and daily treatment
16104418|NCT02129998|Other|IVF/ICSI treatment|
16104419|NCT02129985|Drug|Exenatide|Exenatide (10 ug/bid for 3 months)
16104420|NCT02129985|Drug|Metformin|Metformin 850 mg/bid for 3 months
16104421|NCT02129972|Device|Colon videocapsule endoscopy (PillCam colon 2)|"This is a simple blind (blind for the lecture of the CVC record) study to evaluate the diagnostic value of the colon capsule endoscopy for the detection and the control of colon lesions, the feasibility, tolerance and safety of the CVC compared to the conventional colonoscopy under general sedation in children presented with Inflammatory Bowel Disease.
~Over one week, the patient will undergo two exams (CVC and colonoscopy under general sedation). The exams will be done by two different physicians.
~In order to assess the tolerance, after the completion of both exams, the patients will be asked to answer a comfort score questionnaire.
~In order to assess the safety of the CVC, the patients will have a follow-up for adverse events over a 3 weeks period after completion of the CVC and only if the colon video capsule was not recovered during the conventional colonoscopy."
16104422|NCT02129946|Other|Resistant Starch|In a randomized crossover fashion, participants will consume bagels that are made with either high-resistant starch or standard wheat flour, daily for a period of 8 weeks, with a 4 week washout period.
16104423|NCT02129933|Drug|Bevacizumab-IRDye800CW|"Intravenous administration of a microdose (4.5mg, subtherapeutic) of Bevacizumab-IRDye800CW 2 days prior to the fluorescence endoscopy procedure.
~* amendment June 2015: topical administration bevacizumab-800CW (100ug/ml)"
16104424|NCT02129933|Device|Near infrared fluorescence endoscopy platform|A flexible fiber-bundle is attached with its proximal end to a camera which can detect near infrared fluorescent light. The distal end is inserted into the working channel of a clinical video endoscope to visualize the luminal wall. The fluorescent imaging will be performed prior and post the endoscopic resection (within the same endoscopic session)
16104425|NCT02129920|Other|This is an observational study|
16104426|NCT02129894|Device|abdominal Binder|placement of abdominal binder
16104427|NCT02129881|Biological|Autologous regulatory T Cell Product|Autologous regulatory T Cell Product (1-10 million cells/kg) infused intravenously 5 days post renal transplantation. Recipients also receive prednisolone, mycophenolate mofetil, and tacrolimus as detailed in the arm description.
16104428|NCT02129868|Device|Closed-loop (Android Closed-Loop platform)|"The closed-loop system is purpose-built and comprises a hand-held computer containing a model predictive control (MPC) based glucose control algorithm and communicating with the CGM device and the insulin pump.
~The Android Closed-Loop platform employs the Medtronic MiniMed Paradigm® Veo™ insulin pump system with CGM capability (use of MiniLink™Transmitter and sensor). A Radiofrequency (RF) translator module translates the RF protocol to Bluetooth® technology. An Android device containing an algorithm will use sensor glucose data to calculate pump strokes."
16104429|NCT02129829|Drug|Tenofovir disoproxil|Tenofovir disoproxil 245 mg once daily
16104430|NCT02129816|Drug|Bryophyllum|
16104433|NCT02129790|Behavioral|Mentalization-Based Therapy|Up to 21 individual MBT-A sessions plus 9 monthly family sessions. MBT-A sessions will focus on the adolescent's recent social experiences and the resulting mental states and managing interpersonal challenges, particularly those involving separation or loss. The goal of this intervention is to improve the adolescent's ability to mentalize: to understand, acknowledge, and predict thoughts and feelings in oneself and others.
16104434|NCT02129777|Drug|Namilumab|Namilumab subcutaneous injection
16104435|NCT02129777|Drug|Placebo|Placebo subcutaneous injection
16104436|NCT02129764|Drug|Prednisone|
16104437|NCT02129764|Drug|Allopurinol|
16104438|NCT02129751|Drug|bupropion hydrobromide|study drug
16104439|NCT02129751|Drug|Placebo|placebo arm
16104440|NCT02129738|Device|LoFric catheters|LoFric single use catheters to be used 4-6 times daily for 4 weeks.
16104441|NCT02129725|Drug|Sildenafil citrate|Sildenafil citrate 25 mg, 1 capsule three times a day for 3 months
16104442|NCT02129725|Drug|Placebo Oral Capsule|placebo capsules, 1 capsule po three times a day for 3 months
16104443|NCT02129712|Behavioral|Cognitive training|
16104444|NCT02129699|Drug|Denosumab|Denosumab: 120 mg, s.c. every 3-4 weeks (in cycle 1 additional dose on day 8) until unacceptable toxicity, patient refusal or patient's death (max. 4 years 3 months).
16104445|NCT02129699|Other|None, standard chemotherapy only|"Possible standard chemotherapies (3 weeks cycles, duration: 4 - 6 cycles):
~Cisplatin 75 mg/m2 as an infusion on day 1 Gemcitabine 1250 mg/m2 as an infusion days 1 and 8 or Carboplatin AUC 5 as an infusion on day 1 Gemcitabine 1000 mg/m2 as an infusion days 1 and 8 or Cisplatin 75 mg/m2 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1 or Carboplatin AUC 5 as an infusion on day 1 Pemetrexed 500 mg/m2 as an infusion on day 1"
16104446|NCT02129686|Procedure|Immediate Acupuncture Group|
16104447|NCT02129686|Procedure|Delayed Acupuncture Group|
16104448|NCT02129673|Drug|VS101 Insert Dose A|Sustained release of latanoprost into the eye
16104449|NCT02129673|Drug|VS101 Insert Dose B|Sustained release of latanoprost into the eye
16104450|NCT02129673|Drug|VS101 Insert Dose C|Sustained release of latanoprost into the eye
16104451|NCT02129673|Drug|Latanoprost 0.005% eye drops|Latanoprost 0.005% eye drops administered once daily on the eye
16104452|NCT02129660|Drug|Dose 1 of glycopyrrolate, 2.0% QD|Dose 1 of glycopyrrolate Topical Wipes
16104453|NCT02129660|Drug|Dose 2 of glycopyrrolate, 3.0% QD|Dose 2 of glycopyrrolate Topical Wipes
16104454|NCT02129660|Drug|Dose 1 of glycopyrronium, 2.5% QD|Dose 1 of glycopyrronium Topical Wipes
16104455|NCT02129660|Drug|Dose 2 of glycopyrronium, 3.75% QD|Dose 2 of glycopyrronium Topical Wipes
16104456|NCT02129660|Other|Vehicle|Vehicle Topical Wipes
16104457|NCT02129647|Drug|Axitinib|
16104458|NCT02129634|Device|CB-PTA|
16104459|NCT02129634|Device|DEB-PTA|
16104460|NCT02129621|Procedure|Urinary and blood lipococalin levels determination|Blood test on an empty stomach. Urinary taking on arrival in the service
16104461|NCT02129621|Drug|Spironolactone|For the group 5, at the time of the V0 visit, a treatment by aldactone will be set up (posology: 1 to 2 mg/kg).
16104462|NCT02129608|Device|LLLT|The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.
16104463|NCT02129608|Drug|Lorcaserin|10 mg pills twice daily for 12 weeks.
16104464|NCT02129595|Dietary Supplement|placebo|A placebo will given for 30 days or 34 days (if included in brown adipose tissue measurement), twice daily. One pill will be provided with lunch, and the other pill will be provided with dinner.
16104465|NCT02129595|Dietary Supplement|resveratrol|resveratrol will be given for 30 days or 34 days (if included in brown adipose tissue measurement), twice daily. One pill, which contains 75 mg of resveratrol, will be provided with lunch, and the other pill, also containing 75 mg will be given with dinner. So in total a dose of 150 mg/day will be given.
16104466|NCT02129582|Radiation|total marrow irradiation|Undergo TMI
16104467|NCT02129582|Drug|fludarabine phosphate|Given IV
16104468|NCT02129582|Drug|busulfan|Given IV or PO
16104469|NCT02129582|Procedure|myeloid progenitor cell transplantation|Undergo allogeneic hematopoietic progenitor cell transplant
16104470|NCT02129582|Biological|anti-thymocyte globulin|Given IV
16104471|NCT02129582|Drug|tacrolimus|Given IV or PO
16104472|NCT02129582|Drug|methotrexate|Given IV
16104473|NCT02129582|Other|laboratory biomarker analysis|Correlative studies
16104474|NCT02129569|Other|Psychoeducational intervention|Receive information about strategies for cognitive self-management of distress
16104475|NCT02129569|Behavioral|behavioral intervention|Receive individualized walking prescription and wear pedometer
16104476|NCT02129569|Other|counseling intervention|Receive supplemental counseling support over the phone
16104477|NCT02129569|Other|educational intervention|Receive NCI educational booklets and a link to the ACS website
16104478|NCT02129569|Other|telephone-based intervention|Receive calls that are primarily social in nature
16104479|NCT02129569|Other|questionnaire administration|Ancillary studies
16104480|NCT02129569|Other|quality-of-life assessment|Ancillary studies
16104481|NCT02129556|Drug|MK-3475|The phase Ib trial will determine the recommended dose from three MK-3475 dose levels: 1mg/kg, 2 mg/kg or 10 mg/kg.
16104482|NCT02129543|Procedure|Blood Draw|Whole blood samples will be collected from study subjects for immune cell and plasma analysis per protocol.
16104483|NCT02129530|Behavioral|Community Social Mobilization program|
16104484|NCT02129517|Other|IMPACT intervention|Tailored, web-based educational short video clips
16104485|NCT02129517|Other|Online education materials|Online NCI-based educational materials
16104486|NCT02129517|Other|survey administration|Ancillary studies
16104487|NCT02129504|Device|root coverage comparing two techniques|The aim of this study was to compare and show the benefits of the extended flap technique (new technique) compared to coronal advanced technique (gold standard technique) both techniques using the porcine collagen matrix for root coverage.
16104534|NCT02129166|Drug|Dasatinib+Imatinib|"In this group, subjects will take imatinib prior to dasatinib administration.
~Dose regimen: Imatinib: 400 mg single oral dose Dasatinib: 20 mg single oral dose"
16104488|NCT02129478|Drug|Olanzapine|"Patients will receive olanzapine once daily starting just before the first dose of chemotherapy within the study chemotherapy block and continuing until discharge from hospital or for a maximum of 4 doses after the last dose of chemotherapy.
~Olanzapine will be dosed at 0.14mg/kg/dose (maximum 10mg/dose) as a single daily oral dose rounded to the nearest increment of a half-tablet (2.5mg)."
16104489|NCT02129439|Drug|SB012|"The treatment phase lasts 28 consecutive days. The IMP will be administered for the first time at the study site in the morning on Day 1 (IMP administration training by study site staff). The final administration will be performed at the study site in the morning of Day 28. On all other treatment days (Day 2 to Day 27), the IMP will be self-administered by the subject at home.
~SB012 will be available in this clinical trial in a concentration of 7.5mg/ml hgd40 in 30ml PBS (Maximum daily dose: 225mg)
~The IMP is formulated as an enema and will be administered in this clinical trial by the rectal route. The enema is a ready-for-use preparation. No further preparation steps are required.
~No modifications are permitted to the dosing regimen except for premature study discontinuation."
16104490|NCT02129439|Drug|Placebo|"Intervention of placebo-treated subjects does not vary to SB012-treated subjects.
~The treatment phase lasts 28 consecutive days. Placebo will be administered for the first time at the study site in the morning on Day 1 (Administration training by study site staff). The final administration will be performed at the study site in the morning of Day 28. On all other treatment days (Day 2 to Day 27), the IMP/Placebo will be self-administered by the subject at home. Placebo will be administered with a volume of 30ml.
~The IMP/Placebo is formulated as an enema (plastic rectal tube) and will be administered in this clinical trial by the rectal route. The enema is a ready-for-use preparation. No further preparation steps are required."
16104491|NCT02129426|Drug|Ketamine|Sedation medication
16104492|NCT02129426|Drug|Midazolam|Sedation medication
16104493|NCT02129426|Drug|Dexmedetomidine|Sedation medication
16104494|NCT02129413|Device|Delta system|
16104495|NCT02129400|Drug|Xenon pro Anaesthesia 100 % (V/V)|Xenon-gas inhalation of indicated concentrations during indicated time
16104496|NCT02129400|Drug|Aer medicinalis Linde 100%|
16104497|NCT02129374|Procedure|Direct repair of pars defect|Direct repair at pars defect was performed with 4.5mm cortical screw in young spondylolytic patients.
16104500|NCT02129348|Drug|Lithium|
16104501|NCT02129348|Drug|Placebo|
16104502|NCT02129335|Other|stress|stress level and survival
16104503|NCT02129322|Drug|Sorafenib|
16104504|NCT02129322|Drug|S-1|
16104505|NCT02129322|Drug|Oxaliplatin|
16104506|NCT02129309|Procedure|Forearm plethysmography|Dose response study
16104507|NCT02129309|Procedure|Haemodynamic studies|Dose response study
16104508|NCT02129296|Device|Air filled balloon|Balloon filled with air according to the manufacturing company orders
16104509|NCT02129296|Device|Bioenteric BIB® balloon|Balloon filled with saline and methylene blue according to the manufacturing company orders
16104510|NCT02129283|Behavioral|Simulation training|End-of-life simulation training. The simulation training will include training with standardized patients (actors) using 9 essential skills for communication and interpersonal relationships. The control group will have no training.
16104511|NCT02129270|Drug|Lidocaine HCl 2% .|comparison of different dosages of drug
16104512|NCT02129270|Drug|Lidocaine HCl 1%|comparison of different dosages of drug
16104513|NCT02129257|Drug|AFLIBERCEPT|
16104514|NCT02129257|Drug|Irinotecan|
16104515|NCT02129257|Drug|5-Fluorouracil|
16104516|NCT02129257|Drug|Folinic Acid|
16104517|NCT02129244|Other|NCM-Plus|"The NCM will follow the domains of the chronic care model by:
~Assuring effective, efficient clinical care and self-management support
~Promoting clinical care consistent with scientific evidence and patient preferences
~Organizing data to facilitate efficient, effective care
~Empowering and preparing patients to manage their health and health-care needs
~Mobilizing community resources to meet the needs of patients"
16104518|NCT02129231|Drug|calcined magnesia|We ensured the patient took the drug at night before meals
16104519|NCT02129231|Drug|Ezetimibe/simvastatin|We ensured the patient took the drug at night before meals
16104520|NCT02129231|Drug|Rosuvastatin|We ensured the patient took the drug at night before meals
16104521|NCT02129218|Other|questionnaire administration|Ancillary studies including three day food record, twenty-four hour dietary recall, and a food acceptability questionnaire.
16104522|NCT02129218|Other|laboratory biomarker analysis|Correlative studies
16104523|NCT02129218|Behavioral|Standard Dietary Intervention|Participants will be contacted by a nutritionist, in person every 2 weeks with phone contact on the alternating weeks. At the initial visit, each participant will be given verbal and written patient education materials, including low glycemic load diet recipes, meal plans, food preparation, and grocery shopping information. Individual instruction will be tailored to their baseline dietary preferences (e.g. vegan, allergies, etc).
16104524|NCT02129218|Behavioral|Intensified Dietary Intervention|Patients will be contacted weekly, in person, by a nutritionist . Participants will take part in a cooking demonstration at the time of their initial visit. The demonstration will be hands-on and participants will be able to sample foods and recipes. In addition to grocery shopping information, participants will be accompanied by a nutritionist to their local grocery store to practice new shopping habits for their target dietary glycemic load. Each participant will also receive weekly random phone calls to assess his or her progress.
16104525|NCT02129218|Behavioral|Low glycemic load|
16104526|NCT02129218|Behavioral|Medium Glycemic Load|
16104527|NCT02129205|Drug|PF-06650808|Dose Escalation Phase [Part 1] - PF-06650808 will be administered at doses starting at 0.2 mg/kg. Increases in dose will continue until MTD is determined.
16104528|NCT02129205|Drug|PF-06650808|Dose Expansion Phase [Part 2] - Patients will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.
16104529|NCT02129192|Drug|Amlodipine 5mg capsule|Amlodipine 5mg capsule
16104530|NCT02129192|Drug|T80/H12.5 mg FDC tablet|Telmisartan 80 mg/Hydrochlorothiazide 12.5 mg FDC tablet
16104531|NCT02129192|Drug|T80/A5/H12.5 mg FDC tablet|Telmisartan 80 mg/Amlodipine 5 mg/Hydrochlorothiazide 12.5 mg FDC tablet
16104532|NCT02129179|Drug|Glucagon-Like Peptide 1|
16104535|NCT02129153|Behavioral|LIFT (Parent Information)|"Parents will receive specific information about class assignments that the student missed or about poor performance on tests/quizzes. Parents will also be notified about behavioral problems, such as poor attention and class disruption. RA will communicate with parents in Spanish or English by text message, phone, email according to the parents preference for communication
~Parents will be invited to parenting seminars to discuss parenting strategies regarding what to do with their child's academic and behavioral information once they receive it from research staff. Sessions will take place at school and last 2 hours. Multiple sessions will be offered throughout the academic year and parents may attend as many sessions as they wish."
16104536|NCT02129140|Device|Hernia graft/mesh|observational group
16104537|NCT02129127|Device|Paclitaxel Coated Chocolate Balloon Angioplasty|Balloon Angioplasty with the Chocolate Balloon resulting in vessel dilatation and localized delivery of Paclitaxel
16104538|NCT02129114|Device|ReDura Onlay|Subject will be clinically followed post-surgery until hospital discharge or within ten (10) days of the procedure and at three (3) months and six (6) months. The data up to and including the 6 month follow-up visit will be used in demonstrating the performance of ReDura Onlay.
16104539|NCT02129114|Device|DuraGen|Subject will be clinically followed post-surgery until hospital discharge or within ten (10) days of the procedure and at three (3) months and six (6) months. The data up to and including the 6 month follow-up visit will be used in demonstrating the performance of DuraGen.
16104540|NCT02129101|Drug|Azacitidine|Given SC or IV
16104541|NCT02129101|Drug|Decitabine|Given IV
16104542|NCT02129101|Other|Laboratory Biomarker Analysis|Correlative studies
16104543|NCT02129101|Other|Quality-of-Life Assessment|Ancillary studies
16104544|NCT02129101|Drug|Sonidegib|Given PO
16104545|NCT02129088|Drug|Esketamine|Esketamine 14 mg will be self-administered by participants as intranasal spray into each nostril on Day 1 to cohort 1 and cohort 2 in a fixed sequence.
16104546|NCT02129088|Drug|Placebo|Placebo will be self-administered as intranasal spray by participants after 5 and 10 minutes of esketamine administration into each nostril on Day 1 of Treatment period 2 to Cohort 2.
16104547|NCT02129075|Biological|DEC-205/NY-ESO-1 Fusion Protein CDX-1401|Given SC or ID
16104548|NCT02129075|Other|Laboratory Biomarker Analysis|Correlative studies
16104549|NCT02129075|Biological|Neoantigen-based Melanoma-Poly-ICLC Vaccine|Given SC
16104550|NCT02129075|Other|Pharmacological Study|Correlative studies
16104551|NCT02129075|Biological|Recombinant Flt3 Ligand|Given SC
16104552|NCT02129062|Drug|Ibrutinib|Given orally 560 mg daily (dispensed as 4 x 140-mg capsules)
16104553|NCT02129062|Other|Laboratory Biomarker Analysis|Correlative studies
16104554|NCT02129049|Other|educational intervention|Participate in the Enhancing Connections Telephone Program
16104555|NCT02129049|Behavioral|telephone-based intervention|Participate in the Enhancing Connections Telephone Program
16104556|NCT02129049|Other|questionnaire administration|Ancillary studies
16104557|NCT02129023|Device|Xbox 360|For each participant in the experimental arm, two Xbox 360 exercise items were randomly selected from the nine items, which are related to user health. Each participant takes the two exercise items in turn.
16104558|NCT02128997|Device|Closed incision wound vacuum (Prevena)|wound vacuum to be placed on a closed incision
16104559|NCT02128984|Dietary Supplement|Symbiotic Formula with DHA and antioxidants|6 months intervention.
16104560|NCT02128984|Dietary Supplement|Standard Formula|6 months intervention.
16104561|NCT02128971|Dietary Supplement|Ferrochel® 90 mg|Ferrochel® capsule 90 mg, administered orally once daily in the morning after breakfast, for 30 days
16104562|NCT02128971|Dietary Supplement|Sumalate® 90 mg|Sumalate® capsule 90 mg, administered orally once daily in the morning after breakfast, for 30 days
16104563|NCT02128971|Dietary Supplement|Ferrous fumarate 90 mg|Ferrous fumarate capsule 90 mg, administered orally once daily in the morning after breakfast, for 30 days
16104564|NCT02128971|Dietary Supplement|Ferrous Sulfate 90 mg|Ferrous Sulfate capsule 90 mg, administered orally once daily in the morning after breakfast, for 30 days
16104565|NCT02128971|Dietary Supplement|Ferric Glycinate 90 mg|Ferric Glycinate capsule 90 mg, administered orally once daily in the morning after breakfast, for 30 days
16104566|NCT02128971|Dietary Supplement|Placebo|Placebo capsule, administered orally once daily in the morning after breakfast, for 30 days
16104567|NCT02128958|Drug|CF102|orally q12h
16104568|NCT02128958|Drug|Placebo|orally q12 hours
16104569|NCT02128945|Other|[18F] - Fludarabine PET/CT|[18F] - Fludarabine PET/CT before treatment
16104570|NCT02128932|Drug|semaglutide|Injected subcutaneously (under the skin) once weekly. Following 4 doses (4 weeks) of 0.25 mg semaglutide weekly subjects will receive 0.5 mg semaglutide weekly for 26 weeks.
16104571|NCT02128932|Drug|insulin glargine|Injected subcutaneously (under the skin) once daily. Subjects will start on 10 IU once daily and the dose will be adjusted according to fasting plasma glucose.
16104572|NCT02128919|Device|tDCS|Transcranial Direct Current Stimulation
16104573|NCT02128906|Drug|Cisplatin|Cisplatin 40 mg/m2 weekly x 7
16104574|NCT02128906|Radiation|IMRT|IMRT: once daily, M-F, 7 weeks (70 Gy)
16104575|NCT02128906|Drug|Docetaxel|Docetaxel 15 mg/m2 weekly x 7
16104576|NCT02128906|Drug|Cetuximab|Cetuximab 400 mg/m2 load, one week prior to IMRT Cetuximab 250 mg/m2 weekly x 7
16104577|NCT02128893|Drug|Isavuconazole|oral
16104578|NCT02128893|Drug|Esomeprazole|oral
16104579|NCT02128880|Behavioral|CARRII|CARRII is an interactive, personalized and tailored Internet intervention designed to reduce the risk of AEP among drinking women of childbearing age.
16104580|NCT02128880|Behavioral|CARRII Education|CARRII Education provides information on women's health related to drinking and contraception in a static website format.
16104581|NCT02128867|Other|Assisted Autogenic Drainage (AAD)|
16104582|NCT02128867|Other|bouncing and AAD|
16104583|NCT02128867|Other|bouncing|
16104632|NCT02128464|Procedure|Patient specific cutting guides|Patient specific cutting guides are custom-made for each patient based on Magnetic Resonance Imaging (MRI). Before surgery, MRI of the knee is done and used to create a cutting guide that is formed to the exact shape of the knee. The patient specific cutting guides have platforms that can be attached to the bone, so the rod does not need to be placed in the leg bone.
16104584|NCT02128854|Behavioral|Tablets Intervention|The TABLET intervention adds a novel tablet-based delivery mechanism to provide real-time videoconferencing education about diabetes self-management behaviors to high-risk, low-income African American (AA) adults with diabetes. Cardiovascular disease (CVD) knowledge/ information modules consist of materials developed from a CVD patient education booklet adapted from Maine Heart Center of Maine Health and supplemented by clinical guidelines to specifically address behavioral risk factors. Motivation/behavioral skills training modules consist of patient activation (asking questions to providers), patient empowerment (CVD responsibility contracts, flow charts for lab results), and behavioral skills training (self-monitoring, goal-setting).
16104585|NCT02128841|Drug|Rivaroxaban|Direct Factor Xa Inhibitor
16104586|NCT02128828|Drug|cenicriviroc|cenicriviroc given once daily for 24 weeks; number of pills dependent on recommended modifications based on patient's other antiretroviral medications and certain other medications anticipated to interact with cenicriviroc
16104587|NCT02128815|Other|Coaching|Care translation - behaviour modification, personalized/tailored diabetes education and psychosocial support
16104588|NCT02128802|Procedure|Gastric Bypass|
16104589|NCT02128802|Other|Weight Loss Program|
16104590|NCT02128789|Other|Elder Tree website|Elder Tree is a private, secure information, support and communication website developed for this study.
16104591|NCT02128776|Other|Comprehensive care medical home|Comprehensive care provided in our High-Risk Children's Clinic as a medical home augmented by measures to prevent serious illness
16104592|NCT02128776|Other|Usual Care|Usual care provided in the offices of private pediatricians or our general pediatrics clinic staffed by faculty-supervised residents.
16104593|NCT02128763|Drug|Omega-3 supplements|2000 mg EPA and 1000 mg DHA per day
16104594|NCT02128763|Drug|Placebo|Olive oil gelcaps manufactured to mimic Omega-3 gelcaps
16104595|NCT02128750|Other|contrast echographie with hexafluorur of sulfur|Echography of contrast after injection of product of contrast (sonovue (r))
16104596|NCT02128737|Behavioral|Sleep|
16104597|NCT02128724|Drug|BKM120|Buparlisib is a highly specific inhibitor of phosphatidylinositol 3-kinase (PI3K). Buparlisib is supplied as 10mg and 50mg hard gelatin capsules.
16104598|NCT02128698|Dietary Supplement|Protein|Postoperative intake of 25 g per day starting on the first day after hospital discharge until 6 months postoperatively.
16104599|NCT02128698|Dietary Supplement|Placebo|Postoperative intake of 25 g per day starting on the first day after hospital discharge until 6 months postoperatively.
16104600|NCT02128698|Behavioral|Computer-assisted exercise|Postoperative regular computer-assisted exercise using Nintendo Wii Mini, Nintendo Wii Balance Board and Wii Fit Plus Software. Exercise is advised to be done 4 times per week.
16104601|NCT02128698|Behavioral|Usual exercise|Postoperative regular exercise using written exercise instructions. Exercise is advised to be done 4 times per week.
16104602|NCT02128685|Drug|Dydrogesterone|
16104603|NCT02128685|Drug|Placebo|
16104604|NCT02128672|Procedure|Spinal Cord Stimulator Lead Placement|
16104605|NCT02128659|Behavioral|SHE Project|Consists of five-sessions, starting on a Monday and ending Friday. Each day involves an approximately 2 hour session.
16104606|NCT02128646|Drug|EXPAREL|
16104607|NCT02128646|Drug|Ketorolac|
16104608|NCT02128646|Procedure|laparoscopic abdominal hernia repair|
16104609|NCT02128646|Procedure|an open surgery for abdominal hernia repair|
16104610|NCT02128633|Drug|placebo gel|Manipulated at Novaderme ®, Santa Maria, RS, Brazil.
16104611|NCT02128633|Drug|5% sodium fluoride, potassium oxalate 5%, strontium chloride 10%|Manipulated at Novaderme ®, Santa Maria, RS, Brazil.
16104612|NCT02128633|Drug|Fluoride neutral NaF gel 2 %|The product had similar appearance and viscosity than others.
16104613|NCT02128620|Behavioral|Game-Based Appointment System|Users randomized to the www.sjekkdeg.no B version, consisting in the web app www.sjekkdeg.no including the Game-Based Appointment System
16104614|NCT02128607|Device|SNAG|sustained natural apophyseal glide: SNAG / Mulligan technique
16104615|NCT02128607|Device|Sham|
16104616|NCT02128594|Behavioral|Serosorting Intervention|Single session, behavioral intervention
16104617|NCT02128581|Drug|Exendin-9,39|use Exendin-9,39 @ 750pmol/kg/min and Exendin-9,39 @ 300pmol/kg/min to block endogenous GLP-1 in humans after gastric bypass and determine contribution of GLP to satiety after meal ingestion
16104618|NCT02128581|Other|Saline|
16104619|NCT02128568|Behavioral|Youth Readiness Intervention|The YRI brings together six empirically-supported practice elements shown to be efficacious across different mental health interventions, as well as methods intended to socialize youth and improve self-efficacy. Practice elements address the broad scope of problems evidenced in Sierra Leonean war-affected youth and enhance the YRI's pacing, which progresses through three phases traditionally used in trauma treatments (stabilization, integration, connection). The weekly intervention takes place over 12 sessions lasting approximately one hour and a half. Groups are divided by gender and age. Each group is paired with two interventionists of the same gender.
16104620|NCT02128555|Procedure|Total Ankle Replacement|The joints are resurfaced with metal implants and a mobile plastic liner is placed between them as the gliding surface.
16104621|NCT02128555|Procedure|Arthrodesis|The remaining damaged cartilage is removed from the ends of the bone and the two bones are then held together in compression using screws, or plates until they join to become one (bone fusion), so that there is no longer any movement at that joint.
16104622|NCT02128542|Drug|Sofosbuvir|Sofosbuvir 400 mg tablet administered orally once daily
16104623|NCT02128542|Drug|RBV|Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16104624|NCT02128516|Other|oral powder in sachet|
16104625|NCT02128503|Other|HBV DNA level monitoring|HBV DNV level being monitoring regularly
16104626|NCT02128490|Drug|Febuxostat IR|Febuxostat IR over-encapsulated tablets
16104627|NCT02128490|Drug|Febuxostat XR|Febuxostat over-encapsulated capsules
16104628|NCT02128490|Drug|Febuxostat placebo|Febuxostat IR and XR placebo-matching capsules
16104629|NCT02128490|Drug|Colchicine|Colchicine tablets
16104630|NCT02128490|Drug|Naproxen|Naproxen tablets
16104631|NCT02128490|Drug|Lansoprazole|Lansoprazole capsules
16104634|NCT02128451|Drug|Meperdine|15ml 0.5% bupivacaine,25 mg of meperdine and 1 ml of clonidine will be injected epidurally in meperdine Group.
16104635|NCT02128451|Drug|Fentanyl|15ml 0.5% bupivacaine, 25 micrograms of fentanyl and 1 ml of clonidine will be injected epidurally in fentanyl Group
16104636|NCT02128425|Drug|FOLFOXIRI|"irinotecan* 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 3200 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle
~*reduced in UGT1A1 7/7 patients"
16104637|NCT02128425|Drug|FOLFOX|oxaliplatin 85 mg/m² + leucovorin 400 mg/m² +5-FU 400mg/m² bolus iv.+ 5-FU 2400 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle
16104638|NCT02128412|Device|Oversized stent deployed at low pressure (Multi-Link Bare Metal Stent or Xience Prime Evenolimus Eluting Stent)|Stent can include both bare metal stents and drug eluting stents. Depending on availabilities, different stent brands may be used.
16104639|NCT02128412|Device|Stent deployed at high pressure (Multi-Link Bare Metal Stent or Xience Prime Evenolimus Eluting Stent)|Stent can include both bare metal stents and drug eluting stents. Depending on availabilities, different stent brands may be used.
16104640|NCT02128373|Procedure|Usual care|Health care provided by physician, physician's nurse, and social worker
16104641|NCT02128373|Other|computer-assisted intervention|Caregiver will virtually attend visit using the CLOSER intervention
16104642|NCT02128373|Other|Distress Thermometer|Average score of a one item scale (range 0-10) where higher scores indicate more distress
16104643|NCT02128373|Other|Profile of Mood States (POMS-B)|average score of five items scored 0-4 which describe how someone is feeling. Higher scores indicate increased discomfort
16104644|NCT02128373|Other|Quality of Life: Functional Assessment in Cancer Therapy - (FACT)|Average score of FACT which quantitatively assesses brain cancer patient's physiological functional and quality of life. FACT questions are scored 0-4 with higher numbers indicating more functionality
16104645|NCT02128373|Other|Tension-Anxiety Subscale|six item scale which asks to qualitatively describe which areas in you life are causing stress
16104646|NCT02128360|Drug|Letrozole, Gonadotropins|
16104647|NCT02128360|Drug|Gonadotropins|
16104648|NCT02128347|Other|Electronic Patient Portal|RelayHealth is a web-based application that allows patients and clinicians to communicate through a secure, password protected online electronic portal with data transfer capabilities. The system allows physicians and nurses to view patient questions, patient data and transmit messages to patients in response to questions or after clinic visits in an electronic message. In addition, patients can be made aware of upcoming investigations or clinic visits. Patients can also use the interface to identify any proposed changes (which would minimize recall mistakes after clinic visits) and submit queries pertaining to dialysis. Both patients and clinicians are made aware of new messages through email prompt, which moderates the asynchronous nature of electronic communication. Telephone communication can be maintained, but reserved for more urgent issues that require immediate assistance.
16104649|NCT02128334|Drug|Eligard 45 mg Exposure|Subcutaneous injections
16104650|NCT02128321|Drug|Isavuconazole|oral
16104651|NCT02128321|Drug|Repaglinide|oral
16104652|NCT02128321|Drug|Caffeine|oral
16104653|NCT02128308|Drug|Levofloxacin and Streptomycin added|
16104654|NCT02128308|Drug|Moxifloxacin and Kanamycin added|
16104655|NCT02128295|Device|Electric breast pump - A|
16104656|NCT02128295|Device|Electric breast pump - B|
16104660|NCT02128269|Biological|Study Drug- ALXN1007|10 mg/kg IV q 2 weeks x 12 doses
16104661|NCT02128256|Device|Cerament G|
16104662|NCT02128243|Drug|S-1 de-escalation|S-1 30 mg/m² bid d1-14 q21d
16104663|NCT02128243|Drug|Chemotherapy by Investigator's choice|"Polychemotherapy administration as in induction therapy consists of a platinum and fluoropyrimidine compound as well as optional a taxane / an anthracycline compound.
~Two-Drug combinations:
~FLO / mod. FOLFOX-6; Cisplatin, S-1; Cisplatin, 5-FU; Cisplatin, Capecitabine (XP)
~Three-drug combinations:
~EOX/EOF FLOT"
16104664|NCT02128230|Device|myPRS|Genome expression profiling used to identify high-risk and low-risk multiple myeloma
16104665|NCT02128230|Drug|Induction 1 - MEL-10+CFZ-TD-PACE|"Melphalan (MEL) and Carfilzomib (CFZ) will be given into a central venous catheter. Thalidomide (T) is a capsule and Dexamethasone (D) is a pill; both will be taken by mouth. Cisplatin (P), Adriamycin (A), Cyclophosphamide (C) and Etoposide (E) are all given into the vein (IV) by a continuous infusion through a central catheter. After completion of the continuous chemotherapy, Granulocyte colony-stimulating factor (G-CSF), a shot just under the skin to help the bone marrow and blood counts recover more quickly after chemotherapy, will be given.
~Regimen: CFZ 20 mg/m2 on days 1, 5, & 6; MEL 10mg/m2 on day 3; T 200 mg/d, D 40 mg/d, P 10 mg/m2/d, A 10 mg/m2/d, C 400 mg/m2/d, and E 40 mg/m2/d on days 5-8; G-CSF 10 mcg/kg/day from day 11 through end of Peripheral Blood Stem Cell (PBSC) collection.
~Optional Bridging with T 50 mg/d and D 20 mg on day 1-4 every 21 days until 1st transplant."
16104666|NCT02128230|Drug|First Transplant - MEL-80+CFZ-TD-PACE + PBSC (biologic)|"Melphalan (MEL) and Carfilzomib (CFZ) will be given into a central venous catheter. Thalidomide (T) is a capsule and Dexamethasone (D) is a pill; both will be taken by mouth. Cisplatin (P), Adriamycin (A), Cyclophosphamide (C) and Etoposide (E) are all given into the vein (IV) by a continuous infusion through a central catheter. After completion of the continuous chemotherapy, Granulocyte colony-stimulating factor (G-CSF), a shot just under the skin to help the bone marrow and blood counts recover more quickly after chemotherapy, will be given.
~Regimen: CFZ 20 mg/m2 on days -5 & -4; MEL 20 mg/m2/d, T 200 mg/d, D 40 mg/d, P 10 mg/m2/d, A 10 mg/m2/d, C 100 mg/m2/d, and E 80 mg/m2/d on days -5 & -2; PBSC transplant on day 0.
~Optional Bridging with T 50 mg/d and D 20 mg on day 1-4 every 21 days until inter-therapy."
16104700|NCT02127996|Drug|placebo|Normal saline
16104701|NCT02127983|Behavioral|Early intervention|"Training non-paid informal healthcare providers (such as store-keepers) in TB and HIV disease recognition, sputum specimen collection, referral to the public health system, and raising community awareness.
~Front line public health personnel and community leaders were sensitised to support the intervention"
16104702|NCT02127983|Behavioral|Delayed intervention|Delayed intervention arm, engaging informal providers Received the intervention after one year
16104667|NCT02128230|Drug|Inter-Therapy - MEL-20+CFZ-TD-PACE (75%)|"Melphalan (MEL) and Carfilzomib (CFZ) will be given into a central venous catheter. Thalidomide (T) is a capsule and Dexamethasone (D) is a pill; both will be taken by mouth. Cisplatin (P), Adriamycin (A), Cyclophosphamide (C) and Etoposide (E) are all given into the vein (IV) by a continuous infusion through a central catheter. After completion of the continuous chemotherapy, Granulocyte colony-stimulating factor (G-CSF), a shot just under the skin to help the bone marrow and blood counts recover more quickly after chemotherapy, will be given.
~Regimen: CFZ 27 mg/m2 on days 1-2; MEL 5 mg/m2/d, T 200 mg/d, D 20 mg/d, P 7.5 mg/m2/d, A 7.5 mg/m2/d, C 75 mg/m2/d, and E 60 mg/m2/d on days 1-4.
~Optional Bridging with T 50 mg/d and D 20 mg on day 1-4 every 21 days until 2nd transplant."
16104668|NCT02128230|Drug|Second Transplant - MEL-80+CFZ-TD-PACE + PBSC (biologic)|"Melphalan (MEL) and Carfilzomib (CFZ) will be given into a central venous catheter. Thalidomide (T) is a capsule and Dexamethasone (D) is a pill; both will be taken by mouth. Cisplatin (P), Adriamycin (A), Cyclophosphamide (C) and Etoposide (E) are all given into the vein (IV) by a continuous infusion through a central catheter. After completion of the continuous chemotherapy, Granulocyte colony-stimulating factor (G-CSF), a shot just under the skin to help the bone marrow and blood counts recover more quickly after chemotherapy, will be given.
~Regimen: CFZ 20 mg/m2 on days -5 & -4; MEL 20 mg/m2/d, T 200 mg/d, D 40 mg/d, P 10 mg/m2/d, A 10 mg/m2/d, C 100 mg/m2/d, and E 80 mg/m2/d on days -5 & -2; PBSC transplant on day 0.
~Optional Bridging with T 50mg/d and D 20 mg on day 1-4 every 21 days until consolidation."
16104669|NCT02128230|Drug|Consolidation - CFZ-TD-PACE|"Carfilzomib (CFZ) will be given into a central venous catheter. Thalidomide (T) is a capsule and dexamethasone (D) is a pill; both will be taken by mouth. Cisplatin (P), adriamycin (A), cyclophosphamide (C) and etoposide (E) are all given into the vein (IV) by a continuous infusion through a central catheter.
~Regimen: CFZ 27 mg/m2 on days 1-2; T 200 mg/d, D 40 mg/d, P 7.5 mg/m2/d, A 7.5 mg/m2/d, C 300 mg/m2/d, and E 30 mg/m2/d on days 1-4."
16104670|NCT02128230|Drug|Maintenance - CFZ-R(T)-D|"Carfilzomib (CFZ) will be given into a central venous catheter. Thalidomide (T) and lenalidomide (R) are capsules and dexamethasone (D) is a pill; all will be taken by mouth.
~Regimen: For Cycles 1-12 CFZ 27 mg/m2/wk and D 12 mg/wk on days 1, 8, 15, & 22; lenalidomide (R) 15 mg/d on days 1-21. For Cycles 13-24 CFZ 27 mg/m2/wk and D 12 mg/wk on days 1, 8, 15, & 22. T may be substituted for R at 100 mg/day at the treating physician's discretion."
16104671|NCT02128217|Drug|Sofosbuvir|Participants received one 400 mg tablet of sofosbuvir (SOF) orally every morning with food
16104672|NCT02128217|Drug|Ribavirin|Participants received weight-based ribavirin RBV orally, 2 times a day, every morning and every evening, with food. Weight under 75 kg, 600 mg (3 tablets) morning and 400 mg (2 tablets) evening. Weight over 75 kg, 600 mg (3 tablets) morning and 600 mg (3 tablets) evening. The dose of RBV was based on subject's weight at entry. Changes in weight after entry did not require a change in dose. Doses were only changed for toxicity management.
16104673|NCT02128217|Drug|Ledipasvir/Sofosbuvir|Participants received one daily fixed-dose combination tablet orally every morning of 90 mg of Ledipasvir (LDV) and 400 mg of SOF.
16104674|NCT02128204|Device|lidocaine contained hyaluronate facial dermal filler|HYADERMIS LA Facial Dermal Implant contains 20 mg/ml hyaluronate and 0.3 % lidocaine.
16104675|NCT02128204|Device|hyaluronate facial dermal filler|Hya-Dermis Facial Dermal Implant contains 20 mg/ml hyaluronate.
16104676|NCT02128191|Drug|Oral ibuprofen|Initial dose of 10 mg/kg of oral ibuprofen, followed by two doses of 5 mg/kg 24 and 48 hours later
16104677|NCT02128191|Drug|Normal saline|Initial dose of normal saline followed by second and third dose 24 and 48 hours later, at equal volume to ibuprofen arm
16104678|NCT02128178|Drug|Enoxaparin 40 mg 2 hours before arm|Enoxaparin 40 mg 2 hours before surgery
16104679|NCT02128178|Drug|Enoxaparin 40 mg 12 hours before arm|Enoxaparin 40 mg 12 hours before surgery
16104680|NCT02128165|Device|BMI more than 45 BMI|Air filled gastric balloon (Heliosphere) those BMI above 45
16104681|NCT02128165|Device|BMI less than 45 BMI|Air filled gastric balloon (Heliosphere) those BMI below 45
16104682|NCT02128152|Device|Ekso exoskeleton|
16104683|NCT02128126|Drug|ISA101/ISA101b|Four dose levels ISA101/ISA101b
16104684|NCT02128113|Drug|Placebo|Opthalmic suspension manufactured to mimic RTA 408 suspension
16104685|NCT02128113|Drug|0.5% Omaveloxolone Ophthalmic Suspension|0.5% ophthalmic suspension of RTA 408
16104686|NCT02128113|Drug|1% Omaveloxolone Ophthalmic Suspension|1% ophthalmic suspension of RTA 408
16104687|NCT02128100|Drug|Folfirinox|"Oxaliplatin 85 mg/m² for over 2 hours,
~Leucovorin 400n mg/m² for over 2 hours,
~Irinotecan 180 mg/m² for over 90 minutes, along with Leucovorin infusion
~Fluorouracil 400 mg/m² as a fast infusion over 15 minutes
~Fluorouracil 2400 mg/m² as a slow infusion over 46 hours"
16104688|NCT02128100|Radiation|Stereotactic Body Radiation Therapy|5 treatments of stereotactic ablative radiotherapy (SABR) over the course of two weeks with a minimum of 36 hours in between each treatment.
16104689|NCT02128087|Behavioral|Two-way SMS intervention|"Clients will receive a weekly two-way SMS, meaning that the clients in this group will receive the same message as in the one-way SMS study arm, but in addition will be asked how they feel. Clients are required to either press 1 or respond well or press 2 or write 'Unwell in response in the language of their choice within 48 hours. A missing response after 48 hours triggers a second SMS to remind the client to respond. If after 24 more hours the participant still does not respond or if at any point s/he responds unwell then the study coordinator will follow up with a call within 24 hours."
16104690|NCT02128087|Behavioral|One-way SMS intervention group|Clients will receive a weekly one-way SMS message. There will be no prompt for any response.
16104691|NCT02128074|Drug|KRX-0502|1g tablets of KRX-0502
16104692|NCT02128061|Drug|Lenalidomide|
16104693|NCT02128061|Drug|Rituximab|
16104694|NCT02128048|Device|Assessment of body composition and muscle function|Assessment of body composition by DEXA and BIA Measurement of muscle function by hand-grip dynamometer and physical tests Comparison between quitters and continued smokers
16104695|NCT02128035|Procedure|With Lead Shield|"A pelvic lead shield will be draped on patient from umbilicus to knees.
~Interventional cardiologists who will perform the procedure will wear a radiation protection cap in all procedures."
16104696|NCT02128022|Drug|GLP-1 (7-36) amide|Infusion of GLP-1 (7-36) amide 1.2 pmol/Kg/min
16104697|NCT02128022|Drug|Glibenclamide|Oral Glibenclamide 5mg
16104698|NCT02128009|Other|osteoporosis|
16104699|NCT02127996|Drug|GLP-1|GLP-1 (7-36) amide infused at 1.2 pmol/Kg/min
16104705|NCT02127957|Other|Exercise|Exercise will be prescribed by kinesiologist and will be done 3 times a week for 1 hour by subject. Every 4 weeks subject will be on supervised training session.
16104706|NCT02127931|Device|Groundskeeper for ADHD group|Groundskeeper, a Video Game Diagnostic Tool for ADHD is administered to probands with ADHD and age, gender matched controls without ADHD.
16104707|NCT02127931|Device|Groundskeeper for control group|Groundskeeper, a Video Game Diagnostic Tool for ADHD is administered to probands with ADHD and age, gender matched controls without ADHD.
16104708|NCT02127918|Drug|ESES treated with clobazam|The patients that will participate in the protocol will be those that are administered for clinical reasons oral clobazam.
16104709|NCT02127905|Biological|CD34+ selected cells|Compassionate treatment of Fanconi Anemia patients with unrelated bone marrow or peripheral blood HSCT followed by the infusion of CD34+ selected cells using CliniMACS
16104710|NCT02127892|Biological|unrelated BM with T cell depletion|Remaining unmanipulated bone marrow will be processed to isolate CD34+ cells (T cell depleted).
16104711|NCT02127892|Biological|unrelated cord blood|Cord blood will be thawed (and processed if ABO incompatibility) per institutional SOP.
16104712|NCT02127892|Biological|haplo BM with T cell depletion|haplo-identical (parental) bone marrow will be processed for CD34+ cell isolation.
16104713|NCT02127892|Device|unrelated PBSC with T cell depletion|peripheral blood stem cell will be processed for CD34+ cell isolation.
16104714|NCT02127879|Device|Transcranial Magnetic Stimulation|16 sessions/4 days (4 sessions per day), 2000 stimuli per one session, 20 trains per session (train interval= 10 sec., intertrain interval= 30sec.), stimulation intensity 110 % related to the individual resting motor threshold; in total 32,000 stimuli, 20 min. pause is between every stimulation session for safety reasons.v
16104715|NCT02127879|Device|Transcranial Magnetic Stimulation with sham coil|16 sessions/4 days (4 sessions per day), 2000 stimuli per one session, 20 trains per session (train interval= 10 sec., intertrain interval= 30sec.), stimulation intensity 110 % related to the individual resting motor threshold; in total 32,000 stimuli, 20 min. Pause is between every stimulation session for safety reasons.
16104716|NCT02127866|Drug|CHF 5259 plus Foster 100/6 µg|Comparison of different doses of CHF 5259 (on top of Foster 100 /6 µg) versus Foster 100/6 µg over a treatment period of 6 weeks. Each subject will be allocated to 3 ouf of the 4 possible treatments performed in sequence during a cross over design (incomplete block)
16104717|NCT02127866|Drug|Foster 100/6 µg|"Active comparator
~Comparison of different doses of CHF 5259 (on top of Foster 100 /6 µg) versus Foster 100/6 µg over a treatment period of 6 weeks. Each subject will be allocated to 3 ouf of the 4 possible treatments performed in sequence during a cross over design (incomplete block)"
16104718|NCT02127853|Drug|gabapentin|100 mg tid of gabapentin is prescribed to the patient for 1 week after the first eye surgery
16104719|NCT02127853|Drug|placebo|the same regimen of placebo drug is prescribed to the patient for 1 week after the first eye surgery
16104720|NCT02127840|Drug|Synacthen infusion during adrenal venous sampling|Adrenal venous sampling during Synacthen infusion
16104721|NCT02127827|Device|Automated Ambulatory Glycemic Controller (AAGC)|
16104722|NCT02127814|Dietary Supplement|Lactobacillus reuteri|One chewable tablet of 1E8 CFU L. reuteri, once per day
16104723|NCT02127801|Drug|REGN1908-1909|
16104724|NCT02127801|Drug|placebo|
16104725|NCT02127788|Drug|Micafungin|intravenous
16104726|NCT02127775|Drug|Lesinurad 400 mg (manufactured at Site 1)|
16104727|NCT02127775|Drug|Lesinurad 400 mg (manufactured at Site 2)|
16104728|NCT02127762|Behavioral|Mindfulness Based Stress Reduction|Consists of eight weekly 2.5 hour sessions and one 6 hour session midway through the course. All sessions will be conducted by a psychologist or social worker with experience in chronic pain, formal MBSR training and 5 years of experience leading MBSR groups.
16104729|NCT02127749|Drug|Endotoxin|Both groups will receive 2 ng/kg LPS (endotoxin) intravenously
16104730|NCT02127749|Drug|Vancomycin, Metronidazole, Ciprofloxacin|ciprofloxacin 500mg 2 times per day, vancomycin 500mg 3 times per day metronidazole 500mg 3 times per day All together during 7 days
16104731|NCT02127736|Drug|Amitriptyline|
16104732|NCT02127736|Drug|Placebo|
16104733|NCT02127723|Device|Hyaluronic acid injection (Macrolane VRF30)|Injection of Macrolane subcutaneously in the buttocks area to reduce cellulite
16104734|NCT02127710|Drug|AZD6094|AZD6094 is a potent and selective small molecule mesenchymal epithelial transition (c-MET) kinase inhibitor.
16104735|NCT02127697|Drug|NVA237|NVA237 capsules for inhalation, delivered via Concept1 once daily
16104736|NCT02127697|Drug|Placebo to NVA237|Placebo to NVA237 delivered via Concept1 once daily
16104737|NCT02127697|Drug|salbutamol/ albuterol|Taken as rescue medication
16104738|NCT02127684|Drug|ranibizumab|ranibizumab 0.3mg intravitreally monthly
16104739|NCT02127684|Drug|ranibizumab|ranibizumab given every 2 weeks for 8 weeks then monthly as needed
16104740|NCT02127671|Other|IDEAL intervention|
16104741|NCT02127671|Other|Control|
16104742|NCT02127658|Other|Hygiene education|Participants will receive specific hygiene instructions according to existing recommendations.
16104743|NCT02127658|Other|Hygiene education and Decolonization|Participants in this intervention group will receive the same hygiene instructions as the participants in the first intervention group. In addition, intervention number 2 will include the following for all consented household members: Twice weekly 15 minute soaks in diluted bleach water (2/3 cup of 8.25% sodium hypochlorite [Clorox; The Clorox Company] for a standard 50 gallon tub of water, or a teaspoon for each 1.5 gallons of water used) for the duration of 6 weeks. Application of 2% mupiricin ointment by the use of clean swab to the bilateral anterior nares twice daily for ten days
16104744|NCT02127645|Procedure|SRT-TEM|SRT-TEM underwent 25 Gy RT followed by TEM
16104745|NCT02127645|Procedure|LRT-TEM|TEM following 46 Gy RT
16104746|NCT02127645|Procedure|Transanal Endoscopic Microsurgery (TEM)|Transanal Endoscopic Microsurgery (TEM)
16104747|NCT02127645|Procedure|Total Mesorectal Excision (TME)|Laparoscopic Total Mesorectal Excision
16104748|NCT02127632|Device|Endotracheal Tube|ETT:Ruschelit, Teleflex Medical Snd. Bhd. Malaysia. Ref:112482
16104882|NCT02126436|Other|Usual care|The group will receive usual care (including physiotherapy, occupational therapy, medical intervention and any other intervention as deemed appropriate by clinical staff).
16104749|NCT02127632|Device|Laryngeal Mask Airway-Supreme|"Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based K-YTM gel (Johnson & Johnson Ltd. Maidenhead, UK) without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted.
~Other Names:
~LM-S (The Laryngeal Mask Company Limited, Singapore) serial number: 175030 lot: hmabw7"
16104750|NCT02127619|Device|Total knee replacement with the ROCC® knee prosthesis|replacement of an osteoarthritic knee with a total knee prosthesis operation may be for a single knee ( unilateral) or both knees of a patient ( bilateral)
16104751|NCT02127606|Device|Vibration with tilt-table standing|
16104752|NCT02127593|Drug|Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Wet Process)|Norgestimate /Ethinyl estradiol tablets (NGM/EE) containing norgestimate 250 mcg and ethinyl estradiol 35 mcg, formulated by wet process will be orally administered on Day 1 of Period 1 or Period 2.
16104753|NCT02127593|Drug|Norgestimate /Ethinyl estradiol tablets (NGM/EE) (Dry Process)|Norgestimate /Ethinyl estradiol tablets (NGM/EE) containing norgestimate 250 mcg and ethinyl estradiol 35 mcg, formulated by dry process will be orally administered on Day 1 of Period 1 or Period 2.
16104754|NCT02127580|Procedure|BAV|
16104755|NCT02127580|Procedure|without BAV|
16104756|NCT02127567|Other|online writing tool|The writing tool contained the main CONSORT item and extension items for non pharmacological treatments along with bullet points indicating key elements to report from the explanation and elaboration publications of the CONSORT. Participants were also instructed to detail information they felt important to report but that was not available in the study protocol they were provided.
16104757|NCT02127567|Other|writing with no specific support|The control tool simply provided the domain or section heading with a space too write. Similar to for the experimental intervention, participants were to indicate information they felt important to report but unavailable in the provided study protocols.
16104758|NCT02127541|Other|Ga -exendin PET/CT, In- exendin SPECT/CT, MRI|Comparison of different imaging modalities
16104759|NCT02127515|Procedure|Non Invasive Prenatal Testing|
16104760|NCT02127515|Procedure|Invasive Prenatal Testing|
16104761|NCT02127489|Drug|1 mL/kg bupivacaine 0.25%.|40 children between 2 and 10 years of ASA I-II were randomized and they received caudal anesthesia under general anesthesia. Patients underwent the application of caudal block in addition with saline and 1 mL/kg bupivacaine 0.25%. In the postoperative period, Group C (n=20) was given 5mL saline and Group M (n=20) was given 0.30 mg/kg rectal midazolam diluted with 5mL saline. Sedation scale and postoperative pain scale (CHIPPS) of the patients were evaluated. The patients were observed for their analgesic need, first analgesic time, and adverse effects for 24 hours.
16104762|NCT02127476|Drug|KHK6640|Single ascending dose and multiple ascending doses administration
16104763|NCT02127476|Drug|Matching Placebo|Single ascending dose and multiple ascending doses administration
16104764|NCT02127463|Drug|MC-1101|Topically, two times a day, morning and bedtime
16104765|NCT02127463|Drug|MC-1101 Vehicle|Topically, two times a day; morning and bedtime
16104766|NCT02127437|Drug|Lanreotide|120 mg, subcutaneously, once every 4 weeks
16104767|NCT02127437|Drug|saline|0,5 ml, subcutaneously, once every 4 weeks
16104768|NCT02127424|Procedure|Nurse-driven HIV targeted screening|
16104769|NCT02127424|Procedure|Current practice|
16104770|NCT02127411|Behavioral|Mindfulness-Based Relapse Prevention|The MBRP is an adjuvant treatment for people that have been treated for drug use related problems
16104771|NCT02127398|Biological|fecal microbiota|fecal microbiota in capsule form
16104772|NCT02127372|Drug|Docetaxel, Cisplatin and STI571|"Treatment will consist of docetaxel plus cisplatin IV every 21days and oral STI571 given on Days -5 to 2 with each chemotherapy cycle. A maximum of 6 cycles will be given.
~Phase 1 dose levels are:
~Level 1 Docetaxel/Cisplatin 60 mg/m2, STI571 300mg
~Level 2 Docetaxel/Cisplatin 60 mg/m2, STI571 400mg
~Level 3 Docetaxel/Cisplatin 70 mg/m2, STI571 400mg
~Level 4 Docetaxel/Cisplatin 70 mg/m2, STI571 600mg
~Level 5 Docetaxel/Cisplatin 75 mg/m2, STI571 600mg
~Level 6 Docetaxel/Cisplatin 75 mg/m2, STI571 800mg
~Once the MTD level has been established, the previous dose level will be the dosing schedule for Phase II."
16104773|NCT02127372|Drug|Docetaxel|
16104774|NCT02127372|Drug|Cisplatin|
16104775|NCT02127320|Drug|Rosuvastatin 20mg|
16104776|NCT02127320|Drug|Ezetimibe 10mg|
16104777|NCT02127320|Drug|Rosuvastatin 20mg + Ezetimibe 10mg|
16104778|NCT02127294|Device|transcatheter patent foreman ovale closure|
16104779|NCT02127281|Device|Prevena|Device will be applied at end of procedure over closed incision.
16104780|NCT02127268|Drug|Thymosin-α1|with Thymosin-α1 1.6mg twice a week
16104781|NCT02127255|Procedure|Manual acupuncture implemented by acupuncturist 1|Manual acupuncture once per day. Acupuncture treatment regimens (acupoints, needling methods, needle retention time) were decided by acupuncturist 1 according to the syndrome differentiation of patients. Acupuncturist 1 has to have more than 15 years of acupuncture clinical practice experience.
16104782|NCT02127255|Procedure|Manual acupuncture implemented by acupuncturist 2|Manual acupuncture given by acupuncturist 2 once per day. Acupuncture treatment regimens (acupoints, needling methods, needle retention time) were decided by acupuncturist 1 according to the syndrome differentiation of patients. Acupuncturist 2 has to have less than 5 years of acupuncture clinical practice experience.
16104783|NCT02127242|Procedure|ureteroscopic air-pressure ballistic lithotripsy|In case of large, hard or impacted stones ureteroscopic air-pressure ballistic lithotripter is used for fragmentation. The probe of the lithotripter target towards the stone and then fragmented.
16104784|NCT02127229|Procedure|Endoscopist informed of cost per procedure|Following each procedure, endoscopists will get a cost report regarding the amount spent on disposable accessories.
16104785|NCT02127216|Behavioral|MOSES|MOSES is an integrated system between a patient, peer patients, and healthcare providers.
16104786|NCT02127190|Drug|CXA-10 emulsion|CXA-10 Injectable Emulsion is a sterile emulsion containing CXA-10 in a formulation containing soybean oil, medium chain triglycerides oil, egg phospholipids, sucrose, and disodium EDTA. CXA-10 Injectable Emulsion will be administered intravenously. The active emulsion will be diluted in a vehicle emulsion.
16104787|NCT02127190|Drug|Placebo|
16104913|NCT02126111|Biological|DEPIGOID Placebo|Placebo for subcutaneous administration
16104788|NCT02127177|Device|Continuous Positive Airway Pressure Ventilator|CPAP group received fixed-level CPAP titration using an automated pressure setting device for one night. The optimal CPAP pressure for each patient in the CPAP group was set at the minimum pressure required to abolish snoring, obstructive respiratory events, and airflow limitation for 95% of the night, according to a previous validation by our study.
16104789|NCT02127164|Device|"Veraflo device, Dakin's solution"|Veraflo device will be installed on the wound to create negative pressure after surgery. Dakin's solution will be instilled through this device into the wound at the regular intervals.
16104790|NCT02127151|Drug|BMN 673|Starting oral dose of 1.0 mg once daily to be taken until progression, death, unacceptable toxicity, withdrawal consent or any other criterion felt by the Investigator to preclude continuation of treatment.
16104791|NCT02127138|Device|Sirolimus eluting Drug stent|Use the Sirolimus-eluting Drug stents has been approved by the CFDA，But does not allow use taxol-eluting Drug stents and Drug-eluting stent without Polymer.
16104792|NCT02127125|Drug|Maltodextrin|Maltodextrin treatment as a placebo group. Maltodextrin, 6 gm three times a day for 4 weeks.
16104793|NCT02127125|Drug|Synbiotic|Synbiotic [5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming unit (CFU)/g) three times a day) for 4 weeks.
16104794|NCT02127125|Drug|Sevelamer|Sevelamer (1.6 g sevelamer + 4.4 g maltodextrin three times a day), for 4 weeks
16104795|NCT02127112|Procedure|Block Allograft plus Matrix Allograft|A cancellous block allograft plus a demineralized bone matrix allograft will be used as the positive control treatment.
16104796|NCT02127112|Procedure|Moldable Matrix Allograft|The test arm of this study will include a demineralized bone matrix allograft placed over resorbable bone pins.
16104797|NCT02127086|Other|Intervention Group|The PAIN Algorithm and analgesic order sets to be used by nurses to assess and reassess pain and opioid-related side effects will include orders for: 1) managing pain based on MOPAT Behavioral Dimension cut scores, 2) pre-medication before painful procedures, 3) titration of drugs, and 4) managing major opioid side effects. The order sets will start with small doses of opioids that will be titrated upwards for peak analgesic effect and allow for adjustment for patient characteristics and type of pain while simultaneously monitoring for and treating side effects.
16104798|NCT02127073|Drug|Intranasal Oxytocin|Intranasal spray, one spray or 4 IU of oxytocin will be administered into each nostril of each patient about 15-30 minutes before NAF collection
16104799|NCT02127060|Drug|Vitamin C|for 1 month postoperative period, vitamin C was administered orally to the patients.
16104800|NCT02127060|Drug|Placebo drug|for 1 month postoperative period, placebo medication administered orally to the patients.
16104801|NCT02127047|Drug|Sitagliptin|
16104802|NCT02127047|Drug|Exercise|
16104803|NCT02127034|Drug|Mirabegron|oral
16104804|NCT02127034|Drug|Solifenacin|oral
16104805|NCT02127034|Drug|Digoxin|oral
16104806|NCT02127021|Drug|Norzyme® 40000 IU|A kind of pancreatic enzyme supplement containing lipase: 40,000 FIP, amylase: 25,000 FIP, and protease: 1,500 FIP Single capsule of Norzyme® 40000 IU will be prescribed three times a day while taking a meal meal
16104807|NCT02127021|Drug|Placebo|Single capsule of placebo drug with the same appearance of Norzyme® 40000 IU will be prescribed three times a day while taking a meal meal.
16104808|NCT02127008|Procedure|Resection of epidural fat|During surgical procedure, the epidural fat with pituitary forcep and rongeur was resected.
16104809|NCT02127008|Procedure|No resection of epidural fat|During surgical procedure, the epidural fat with pituitary forcep and rongeur was not resected.
16104810|NCT02126995|Drug|MG01CI extended-release tablet|Metadoxine, MG01CI extended-release tablet taken for 6 weeks treatment. Starting with a dose of 700 mg for 2 weeks followed by a 2 weeks of 1400 mg and then 2 weeks of 700 mg or 1400 mg.
16104811|NCT02126969|Radiation|Low dose fractionated radiation - 80cGy with chemotherapy|Chemotherapy + 80 cGy of RT
16104812|NCT02126969|Drug|Docetaxel and Carboplatin AUC 6|Docetaxel 75 mg/m2 and Carboplatin AUC 6 without Radiation
16104813|NCT02126956|Drug|ACT-128800|ACT-128800 was supplied as a powder mix in hard gelatin capsules for oral administration. The capsules contained a co-precipitated mixture of non-radiolabeled and 14C-labeled ACT-128800 formulated at a dose strength of 40 mg with a maximum radioactive content of 102 μCi (3.79 MBq).
16104814|NCT02126943|Drug|Opsumit (macitentan)|10 mg tablets
16104815|NCT02126930|Other|Pharma consult|Upon hospital discharge, patients randomized to the experimental arm will have a pharmaceutical consultation concerning their anti-infectious treatment.
16104816|NCT02126930|Other|Routine care|Patients randomized to this arm will receive care in the habitual manner.
16104817|NCT02126917|Drug|HC-ER + 40% Alcohol|HC-ER 50 mg + 240 mL solution of 40% alcohol/orange juice in fasted state
16104818|NCT02126917|Drug|HC-ER + 20% Alcohol|HC-ER 50 mg + 240 mL solution of 20% alcohol/orange juice in fasted state
16104819|NCT02126917|Drug|HC-ER + 0% Alcohol|HC-ER 50 mg + 240 mL solution of 0% alcohol/orange juice in fasted state
16104820|NCT02126904|Drug|IVA group|
16104821|NCT02126891|Procedure|Tests|Individual parameters of echocardiography and heart rate variability
16104823|NCT02126865|Drug|Placebo to BI 1060469|tablet
16104824|NCT02126865|Drug|BI 1060469 Healthy|tablet
16104825|NCT02126865|Drug|Placebo to BI 1060469 asthmatics|tablet
16104826|NCT02126865|Drug|BI 1060469 asthmatics|tablet
16104827|NCT02126852|Device|Acceleromyography (AMG, one-dimensionally)|Neuromuscular monitoring
16104828|NCT02126852|Device|Acceleromyography (AMG, three-dimensionally)|Neuromuscular monitoring
16104829|NCT02126852|Device|Electromyography (EMG)|Neuromuscular monitoring
16104830|NCT02126839|Drug|Albuterol MDPI|90 mcg/actuation of the multidose dry powder inhaler (MDPI).
16104831|NCT02126839|Drug|Placebo|Matching Placebo delivered via a multidose dry powder inhaler (MDPI).
16104832|NCT02126839|Drug|ProAir HFA inhaler|Rescue medication, ProAir hydrofluoroalkane (HFA) inhaler, was dispensed at the run-in visit for the relief of asthma symptoms to be administered as needed.
16104833|NCT02126826|Drug|BI 1026706|Multiple Rising Doses (oral solution, tablet)
16104834|NCT02126826|Drug|Placebo to BI 1026706|Multiple Rising Doses (oral solution / tablet, identical to active treatment)
16104835|NCT02126813|Procedure|increased interventional threshold for urinary bladder catheterization (800 ml)|
16104838|NCT02126787|Behavioral|Intensive Group Analytic Psychotherapy|The form of intensive group analytic therapy to be used in the trial has been manualized by the research team for the study. It is rooted in group analysis tradition (Bion 1961; Foulkes & Anthony, 1965). It is based on two recent group analytic psychotherapy manuals, one developed by Lorentzen (2014), the other by Garland (2010). The manual has been adapted to day treatment setting and also draws on polish psychoanalytical group experiences practiced in a public service. Like in other psychodynamic short-term therapies this approach is more structured and focused on issues relevant to symptoms relief. Thereby additional techniques are used: psychodrama, non-verbal techniques, movie therapy, memoir, summary or relaxation.
16104839|NCT02126787|Behavioral|Intensive transdiagnostic cognitive-behavioral group therapy|GCBT was designed for treatment in naturalistic settings of diagnostically mixed anxiety disorder patients with comorbid Personality Disorders (PD's) (Holas, Szaniawska, Suszek, Błażejewski, & Kokoszka, in prep.). It is based on the transdiagnostic approach to emotional and particularly anxiety disorders that has been developed over the past ten years (Barlow, 2000; Barlow, Allen, & Choate, 2004; Norton, 2006), additionally it includes interventions for personality disorders based of schema therapy and modes of personality disorders. This approach assumes a high overlap between anxiety disorders and is focused on the common aspects of them. Intensive GCBT developed by our group shares the classical assumptions of cognitive-behavioral therapy (Beck, 1976).
16104840|NCT02126761|Biological|Adjuvanted, trivalent subunit influenza vaccine|Group 1 and group 5 are active comparators; group 5 includes placebo comparator as a second injection in contralateral deltoid
16104841|NCT02126761|Biological|Adjuvant level modified adjuvanted, trivalent subunit influenza vaccine|Group 2 and group 6 are experimental; group 2 has double dosage of MF59 in a single injection; group 6 has triple dosage of MF59 and includes placebo comparator in contralateral deltoid
16104842|NCT02126761|Biological|Antigen level modified adjuvanted, trivalent subunit influenza vaccine|Group 3 is experimental with double the usual antigen dosage
16104843|NCT02126761|Biological|Antigen and adjuvant level modified adjuvanted, trivalent subunit influenza vaccine|Group 4 and 7 are experimental; group 4 has one injection with double the antigen and adjuvant; group 7 has two injections with double the antigen and adjuvant
16104844|NCT02126748|Other|inhalation 4ml hypertonic saline 3% 3x/day|
16104845|NCT02126748|Device|Intrapulmonary Percussive Ventilation|
16104846|NCT02126748|Procedure|Assisted Autogenic Drainage|
16104847|NCT02126722|Procedure|Gastroscopy|Gastroscopy with multiple biopsies will be performed in all patients enrolled
16104848|NCT02126722|Device|EndoFaster test|During the gastroscopy the EndoFaster test will be carried out in all patients enrolled.
16104849|NCT02126722|Other|Clo test|During the gastroscopy the Clo test will be carried out in all patients enrolled.
16104850|NCT02126722|Other|Faecal Helicobacter pylori antigen|On the day of the endoscopic procedure all the enrolled patients will bring a stool sample for the detection of Helicobacter pylori antigen.
16104851|NCT02126709|Drug|Repigel|Repigel will be used as the intervention in the treatment group
16104852|NCT02126683|Drug|Hydroxychloroquine|
16104853|NCT02126670|Drug|ACT01|
16104854|NCT02126670|Drug|Comp01|
16104855|NCT02126670|Drug|Comp02|
16104856|NCT02126670|Drug|Comp03|
16104857|NCT02126670|Drug|Comp04|
16104858|NCT02126657|Drug|70% glycolic acid|
16104859|NCT02126644|Drug|70% glycolic acid|
16104860|NCT02126579|Biological|Peptide Vaccine (LPV7) + Tetanus peptide|1.5 mL administered half intradermally and half subcutaneously.
16104861|NCT02126579|Other|PolyICLC|1 mL administered half intradermally and half subcutaneously
16104862|NCT02126579|Other|Resiquimod|500 mg applied to vaccine site after vaccine administration
16104863|NCT02126579|Other|IFA|2 mL administered half intradermally and half subcutaneously
16104864|NCT02126566|Device|Administration of light therapy - measurement of results before and after therapy|
16104865|NCT02126553|Other|Laboratory Biomarker Analysis|Correlative studies
16104866|NCT02126553|Drug|Lenalidomide|Given PO
16104867|NCT02126540|Device|Pantheris Atherectomy System|Treatment device in primary cohort arm; OCT image guided directional atherectomy
16104868|NCT02126527|Drug|auranofin|Given PO
16104869|NCT02126527|Drug|sirolimus|Given PO
16104870|NCT02126527|Other|laboratory biomarker analysis|Correlative studies
16104871|NCT02126527|Other|pharmacological study|Correlative studies
16104872|NCT02126514|Drug|AZD3293|7 subjects will receive AZD3293
16104873|NCT02126501|Other|Gradual pressure wean|NCPAP will be removed by gradually decreasing pressure over 24 hours once the weaning is decided
16104874|NCT02126488|Behavioral|treadmill slip perturbation|Group A will receive perturbation training on a treadmill with precisely controlled slip-like displacements and then encounter an unannounced novel slip during over-ground walking.
16104875|NCT02126488|Behavioral|treadmill training placebo|An age-matched control group (Group B) will receive only placebo training (on the same treadmill for the same duration but without perturbation) but encounter an identical novel slip during their over-ground walking.
16104876|NCT02126488|Behavioral|observation training|An age-matched observation-training group (Group C) will watch a training video and slides. When exposed to an identical novel slip in over-ground walking, they will know where and how the slip is going to occur and how to resist a fall.
16104877|NCT02126462|Biological|Na-APR-1 (M74)/Alhydrogel®|
16104878|NCT02126462|Biological|Na-GST-1/Alhydrogel®|
16104879|NCT02126462|Biological|Hepatitis B vaccine|Hepatitis B vaccine co-administered with saline
16104880|NCT02126449|Other|Fasting mimicking diet|
16104881|NCT02126436|Other|Acupuncture|"Participants will receive a course of traditional Chinese acupuncture. Acupuncture will be pragmatic but strict guidelines will be adhered to including:
~using a combination of body and auricular acupuncture, treating the opposite limb to amputation and possibly the residual limb, using auricular acupuncture points such as shen men, sympathetic, points corresponding to the lower limb, using body acupuncture points around the stump (depending on tissue health and the patient), mirroring local and distal points by needling them on the opposite limb, points on the lower back taking a segmental approach to dermatomal pain, including points such as LI4 + LR3, LR3, GV20, SP10, electro-acupuncture may be used, retaining the needles for 20-30 minutes, treating twice weekly for four weeks."
16104883|NCT02126423|Other|Conjunctival and nasopharyngeal swabs|For conjunctival samples, a sterile swab is moistened with ophthalmic balanced salt solution and gently swept along the lower fornix from the medial to the lateral canthi, with all attempts to avoid the eyelashes and eyelids. For nasopharyngeal cultures, the sterile swab is inserted 2 cm into the naris and rotated against the anterior nasal mucosa for 3 seconds.
16104884|NCT02126397|Procedure|polyps resection with Laser Diode|resection of endometrial polyps by hysteroscopy without anesthesia
16104885|NCT02126397|Procedure|polyps resection with bipolar electrode|
16104886|NCT02126384|Drug|pneumovax vaccination|vaccination
16104887|NCT02126371|Drug|LEO32731|
16104888|NCT02126358|Drug|Gemigliptin and/or Rosuvastatin|
16104889|NCT02126345|Device|MASTER SL femoral stem and DELTA TT acetabular cup|
16104890|NCT02126332|Other|ropivacaine and sufentanil|Thoracic epidural analgesia will be performed using ropivacaine (2 mg/ml), sufentanil (0.5 microg/ml) administered through a patient-controlled deviced (PCEA : patient-controlled epidural analgesia). PCEA parameters will be fixed as follows : continuous administration of 5 to 15 ml/h and bolus of 3 to 10 ml every 10 minutes. Iterative epidural administration of clonidine (1 mckg/kg) will be allowed to achieve analgesia goals.
16104891|NCT02126332|Other|acetaminophen, nefopam, tramadol, opidoids|Conventional analgesia will include enteral and/or parental administration of usual analgesics, ranging from step 1 to step 3 drugs according to WHO classification (including acetaminophen, nefopam, tramadol, opidoids). The route, dose and frequency of analgesics administrations will be based on participating ICUs protocols.
16104892|NCT02126319|Behavioral|Cognitive Affective preparation|"Forty five minute cognitive-affective preparation session, wherein individuals were encouraged to experience and self-assess their personal reactions to the information they had just received about their prostate cancer risk status, and to anticipate (pre-live) and role play their potential psychological reactions to normal and abnormal test results and associated follow-up diagnostic and management recommendations. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)"
16104893|NCT02126319|Behavioral|General Health Education|A general health educational comparison session administered by research staff in order to equate for factual content, time, and attention. Participants in this session received information of relevance to men at risk for Pca, focusing on recommendations for general health (i.e., diet, exercise, alcohol use, and smoking) and were encouraged to freely probe, explore, and discuss their own attitudes, beliefs, expectations, and feelings about these topics in an interactive format. Combined with standard Prostate Risk Assessment Program (Group Prostate Cancer Education Session, Individual Counseling, Screening feedback)
16104894|NCT02126306|Drug|Beta Glucosylceramide|Beta Glucosylceramide
16104895|NCT02126306|Drug|Placebo|normal saline
16104896|NCT02126293|Drug|Zinc Supplement|
16104897|NCT02126293|Procedure|Repeat blood and urine tests|
16104898|NCT02126280|Other|In vitro estimation of individual reactivity of monocytes|Technique for isolation/separation of monocytes with culture purity more than 95 % CD14-positive cells according to flow cytometry, the share of viable cells at least 98% by trypan blue vital staining, capable of producing TNFa at concentration of at least 50 pg/ml when stimulated with 100 ng/ml IFN-gamma, and CCL18 at concentration at least 30 pg/ml when stimulated with 10 ng/ml interleukin.
16104899|NCT02126267|Procedure|Scaling and root planing|Scaling procedures were performed per quadrant (30 min. per quadrant) at weekly intervals between sessions;
16104900|NCT02126267|Procedure|Full mouth disinfection|Procedures for scaling and root planing were performed in a single stage (24 hours) divided into two sessions (60 min per session) on two consecutive days
16104901|NCT02126267|Drug|Chlorhexidine gel and gluconate|application of chlorhexidine (CX) (1%) gel in pockets after scaling, brushing tongue for 1 min. with CX (1%) gel and mouthwash at the beginning and end of each session with CX 0.2% for 30 seconds (with the form of a gargle in the last 10 seconds)
16104902|NCT02126267|Drug|Chlorhexidine gluconate solution|Home use fo CX 0.2% for 60 consecutive days after the end of the first session of scaling.
16104903|NCT02126267|Drug|Azithromycin|Azithromycin (500 mg) once daily for 3 consecutive days.
16104904|NCT02126254|Device|Hemodynamic group|NICAS guided treatment
16104905|NCT02126241|Other|NICaS guided CRT optimization|"Baseline CO measurement by NICaS
~AV delay optimization:
~AV delay will be changed (increase and decrease) by 30 ms steps , and for each new AV value, the CO will be real-time measured by NICaS
~The AV delay yielding the maximal CO, will be considered the optimal AV delay
~The device will be programmed using the optimal AV delay
~VV delay optimization:
~After Step 2, the baseline VV delay will be changed (increase and decrease; meaning that we will be pacing alternatively the LV before the RV, then the RV before the LV), by 30 ms steps, and for each new VV value, the CO will be real-time measured by NICaS
~The VV delay yielding the maximal CO, will be considered the optimal VV delay
~The device will be programmed using the optimal VV delay"
16104906|NCT02126215|Procedure|MRI CO2 and O2 stress testing|Pre and post operatively
16104907|NCT02126202|Procedure|Coronary angiography and revascularization if feasible|Coronary angiography and revascularization with PCI or CABG (coronary artery bypass grafting) if feasible
16104908|NCT02126163|Behavioral|Treatment Group|Responsible Drinking intervention sessions include an internet-based, computer-tailored intervention (CTI) grounded in the Transtheoretical Model of Behavior Change (TTM). The intervention includes stage-matched and tailored feedback on alcohol use, alcohol-related problems, and theoretically identified behavior change strategies, as well as access to a web-based portal with stage-matched interactive activities to reinforce and promote stage progression. Finally, the intervention will include 7 months of stage-matched behavior change SMS messages.
16104909|NCT02126137|Drug|Ezetimibe|
16104910|NCT02126124|Device|Sham Treatment|In the sham treatment, the electrical field induced by the sham coil cannot invoke any action potentials and if no action potentials are induced, then the electric field is insignificant and there is no treatment effect on the the brain.
16104911|NCT02126124|Device|Active dTMS Treatment|Deep Transcranial Magnetic Stimulation (dTMS) is a new form of TMS which allows direct stimulation of deeper neuronal pathways than the standard TMS. The Brainsway Coil is a novel dTMS coil desigend to allow deeper brain stimulation without significant increase of electric fields induced in superficial cortical regions.
16104912|NCT02126111|Biological|DEPIGOID phleum|Subcutaneous Immunotherapy with modified extract of Phleum pollen.
16104914|NCT02126085|Procedure|Endovascular recanalisation|"Endovascular recanalisation by mechanical thrombectomy with e.g. stent retriever device, possibly following intravenous thrombolysis within a bridging concept"
16104915|NCT02126072|Dietary Supplement|Alcohol|They consume 1gram of alcohol per kilogram of bodyweight in wine (12%)
16104916|NCT02126072|Dietary Supplement|Water|Volunteers consume the same volume of water as the would in wine according toe the protocol.
16104917|NCT02126059|Behavioral|Reminiscence|"The 10 session topics include Happy to seeing you, Childhood stories, Food flavor, Our old songs, Festival, My family, My Carrier, Unforgettable events, My home, and My award.
~small group intervention (8-12 per group), expected total number of group is 5."
16104918|NCT02126059|Behavioral|Cognitive stimulation|"The 10 session topics include psycial activities, sound, face, food, word association, number and games, being creative, categorizing objects, orientation, and team qiuz.
~small group intervention (8-12 per group), total number of group is 5."
16104919|NCT02126059|Behavioral|Aroma-massage|Researcher will conduct hand and arm massage to a patient, once a week, each time session for 30 mins with natural tested and safe aroma-essential oil.
16104920|NCT02126046|Genetic|unrelated CB following haplo-identical hematopoietic stem cells transplantation|
16104921|NCT02126033|Procedure|take blood samples|
16104922|NCT02126020|Drug|topical infliximab|topical infliximab administered QID for 3 months followed by BID for 9 months
16104923|NCT02126007|Behavioral|Sleep and Rhythm Intervention|
16104924|NCT02126007|Behavioral|Dietary Modifications|
16104925|NCT02125994|Procedure|Interscalene nerve block|
16104926|NCT02125981|Drug|Limaprost|taking Limaprost α-Cyclodextrin Clathrate 1 Tablets (166.67 μg), three times per day
16104927|NCT02125981|Drug|Placebo|taking placebo drug
16104928|NCT02125968|Other|interactive video game|short- and medium-term therapeutic effects
16104929|NCT02125968|Other|therapeutic exercise|short- and medium-term therapeutic effects
16104930|NCT02125955|Dietary Supplement|Prebiotic fiber|Dissolved in water.
16104931|NCT02125955|Dietary Supplement|Placebo|Dissolved in water
16104932|NCT02125942|Behavioral|Central Meditation and Imagery Therapy|mindfulness, guided imagery, meditation
16104933|NCT02125929|Procedure|Robotic surgery|Robotic surgery: enucleation benign Pancreatic Neuroendocrine Tumors
16104934|NCT02125929|Procedure|Laparoscopic surgery|Laparoscopic surgery: enucleation benign Pancreatic Neuroendocrine Tumors
16104935|NCT02125929|Procedure|Open surgery|Open surgery: enucleation benign Pancreatic Neuroendocrine Tumors
16104936|NCT02125916|Other|oxygen therapy|
16104937|NCT02125903|Drug|Ropivacaine|Regional Anesthesia performed with 0.375% Ropivacaine 15ml (56,25mg)
16104938|NCT02125890|Drug|Tranexamic Acid|two doses of Tranexamic Acid will be given to patients with rupture abdominal aortic aneurysms
16104939|NCT02125877|Drug|Deferasirox dispersible tablet|Deferasirox DT was provided as 125 mg, 250 mg and 500 mg dispersible tablets for oral use.
16104940|NCT02125877|Drug|Defearisox film-coated tablet|Deferasirox FCT was provided as 90 mg, 180 mg and 360 mg film-coated tablets for oral use.
16104941|NCT02125864|Drug|Aflibercept|
16104942|NCT02125851|Other|Xanthan Gum|esophageal mucosal contact time vs sucralose slurry
16104943|NCT02125851|Other|Honey|esophageal mucosal contact time of honey vs sucralose slurry
16104944|NCT02125838|Device|Laryngeal Mask Airway-Supreme|Group LM-S (Laryngeal Mask Airway-Supreme)Before LM-S was inserted, to lubricate the surface in contact with the palate a water-based gel without local anesthetic was applied to completely cover the LM-S cuff. Depending on the patient's body weight For <50 kg, no. 3 Between 50-70 kg, no. 4 Between 70-100 kg, no. 5 LM-S (The Laryngeal Mask Company Limited, Singapore) was inserted.
16104945|NCT02125838|Device|Endotracheal Tube|ETT
16104946|NCT02125812|Other|scaling and systemic moxifloxacin|scaling and root planing (SRP) combined with systemic moxifloxacin
16104947|NCT02125812|Other|scaling and root planing|scaling and root planing
16104948|NCT02125799|Device|Accelerated HF-rTMS (Magstim Rapid 2 stimulator)|Twice daily rTMS sessions involving 10 Hz in 75 trains of 4 seconds duration, with 26 seconds intertrain intervals (6,000 pulses per day) at 120% of the resting motor threshold.
16104955|NCT02125773|Behavioral|Informed Risk Score|Subjects in the intervention arm will receive an estimate of their risk of HIV infection as estimated by the UCSD calculator. The risk of HIV infection will be based on the subject's responses to the self-reported sexual risk questionnaire and the risk of HIV infection in one year will be extrapolated based on continuation of the same risk behavior. The subjects will also be provided the calculated risk if they were to take PrEP. Subjects in the control arm will not be provided with the results of the risk calculators. Both arms will receive standard of care risk reduction education and information sheets about PrEP.
16104956|NCT02125760|Other|Inspiratory Muscle Training (IMT)|Sham IMT at a fixed workload of 10 cmH2O. 5 sets of 10 repetitions, twice a day, 7 days per week, for 4 weeks.
16104957|NCT02125760|Other|High-intensity IMT|High Intensity IMT. The training load is the maximum inspiratory load defined according to patient tolerance. This load will be equivalent to 10 maximal repetitions (RM) as 10 consecutive inspirations (x 5 sessions), twice a day.
16104958|NCT02125747|Other|No Respiratory Therapy|Patients received conventional treatment.
16107313|NCT02109159|Other|A short online video with emotional content|
16104959|NCT02125747|Other|Respiratory Therapy|"Respiratory Therapy consists of postural drainage, positive expiratory pressure (PEP) and vibropercussion (it is a postural drainage method, which uses chest clapping with a flexible wrist and cupped hands or a mechanical vibrator to loosen and mobilize retained secretions that can then be expectorated or drained). Postural drainage is an airways clearance technique in which patient's body is positioned so that the trachea is inclined downward and below the affected chest area.
~The PEP consists of expiratory cycles through a system generating a positive pressure of 10-20 cc (cubic centimeter) water. Vibropercussion is applied by the use of a mechanical system following rib movement during expiration to enhance clearance of secretions.
~Intervention group received 30-minute-sessions twice a day, 7 days per week, during hospitalization period."
16104960|NCT02125734|Drug|QVA149|QVA149 capsules 110/50 µg for inhalation via Concep-1-inhaler device, taken once a day
16104961|NCT02125734|Drug|Tiotropium|Tiotropium 18 µg capsules for inhalation via HandiHaler device taken once a day
16104962|NCT02125721|Drug|Tiopronin 1g per day|500mg PO BID x 7 days
16104963|NCT02125721|Drug|Tiopronin 2g per day|1g PO BID x 7 days
16104964|NCT02125721|Drug|Tiopronin 3g per day|1.5g PO BID x 7 days
16104965|NCT02125708|Device|OvulaRing®|The OvulaRing® is a non-invasive thermometer measuring the intravaginal temperature every 5 minutes. It was originally invented to assess the moment of ovulation and optimize fertility. This plastic ring including a high-tech-sensor thermometer should be placed into the vaginal fornix for a maximum of 30 days, measuring the intravaginal core-temperature 288 times a day.
16104966|NCT02125695|Procedure|Skin Taping|Skin taping from affected and unaffected sites (4 tape harvestings/area plus photograph of taping site)
16104967|NCT02125695|Procedure|Blood Sampling|Sampling for biomarker and basic research in CLE and AD
16104968|NCT02125695|Procedure|Skin Biopsy|As described in the treatment arm
16104969|NCT02125682|Drug|atovastatin 10 mg/day|patients will receive 10 mg of atorvastatin daily for 8 weeks, then wash out for 6 weeks then cross over to atorvastatin 80 mg daily for 8 weeks
16104970|NCT02125682|Drug|Atorvastatin 80 mg/day|patients will receive 80 mg of atorvastatin daily for 8 weeks, then wash out for 6 weeks then cross over to atorvastatin 10 mg daily for 8 weeks
16104971|NCT02125669|Procedure|Laser treatment|Pulsed dye laser 595nm
16104972|NCT02125669|Device|SHAM-Treatment|using the pulsed dye laser (PDL) laser without releasing a pulse
16104973|NCT02125656|Other|High Intensity Interval Training|6 sessions in 2 weeks (Monday, Wednesday and Friday). Each training session will consist of repeated high-intensity efforts in a workload that matches the peak oxygen uptake for 60 seconds. These sprints are interspersed with active recovery for 75 seconds on low intensity (30W). The training sessions will have three minutes of heating in 30W. There will be 8 shots in the first and second session, 10 shots in the third and fourth session and 12 shots in the fifth and sixth session.
16104974|NCT02125643|Drug|Caffeine|
16104975|NCT02125643|Other|Flour|Flour will be administered as the placebo.
16104976|NCT02125630|Procedure|Surgery|Surgery to primary tumor
16104977|NCT02125630|Drug|Systemic therapy|Systemic therapy based on tumor phenotype
16104978|NCT02125617|Drug|Abiraterone|1000 mg/day
16104979|NCT02125617|Drug|Prednisolone|10 mg/day
16104980|NCT02125604|Drug|dimethyl fumarate|capsules administered according to the prevailing product label
16104981|NCT02125591|Device|Active CN-NINM PoNS|Delivery of active stimulation of the tongue during in-person therapy sessions (1 hour) and during two home sessions (40 minutes) daily on 6 of 7 days per week (120 total sessions). Stimulation sessions will be separated by at least 4 hours.
16104982|NCT02125591|Device|Sham CN-NINM PoNS|Delivery of sham stimulation of the tongue during in-person therapy sessions (1 hour) and during two home sessions (40 minutes) daily on 6 of 7 days per week (120 total sessions). Stimulation sessions will be separated by at least 4 hours.
16104983|NCT02125578|Drug|BIIB017 (PEGylated Interferon Beta-1a)|Each participant will receive BIIB017 every other week or every 4 weeks.
16104984|NCT02125578|Drug|Placebo|Each participant will receive placebo every other week or every 4 weeks.
16104985|NCT02125565|Other|Injected subcutaneous local (lidocaine) anaesthesia|Trial of technique
16104986|NCT02125552|Procedure|Ultrasound guidance|The ultrasound machine will be used to guide intravenous line placement in patients randomized to the ultrasound guided intravenous line group
16104987|NCT02125552|Procedure|Traditional intravenous access|Placement by experienced nurse using standard IV techniques
16104988|NCT02125539|Behavioral|Navigating my Journey program|The online relapse prevention program called Navigating my Journey is designed for adolescents who are receiving outpatient treatment for substance abuse. Since the Navigating my Journey program will be available to adolescents 24/7, it is easy for them to access at their convenience. The program functions as an adjunct to treatment and is designed to complement and enhance the work the adolescent does with the counselor during counseling sessions. The core intervention is expected to last for 12 weeks.
16104989|NCT02125539|Behavioral|Attention Control|Client participants in the control group will receive their typical course of counseling and a link to online online health information in PDF form as an attention control.
16104990|NCT02125526|Device|Intra-aortic balloon pump|The intra-aortic balloon pump is placed in the descending thoracic aorta and inflates and deflates in synchrony with the cardiac cycle, providing diastolic augmentation and improving coronary blood flow, while deflating before systole, providing afterload and workload reduction for the myocardium.
16104991|NCT02125513|Drug|carboplatin and paclitaxel followed by surgery|
16104992|NCT02125500|Drug|Sofosbuvir/Ledipasvir fixed dose|SOF 400 mg/LDV 90 mg FDC tablet administered orally once daily
16104993|NCT02125487|Behavioral|Teaching using Hybrid Simulation of breast examination|"Students in the intervention/experimental group will receive the regular lecture given at the American University of Beirut and will attend a screening of an educational video on the technique of CBE, in addition to the hybrid simulation teaching activities in the simulation lab (standardized patient wearing breast examination simulator jackets)"
16104994|NCT02125487|Behavioral|Teaching using traditional method|"Students in the control group will receive the regular lecture given at the American University of Beirut and will attend the usual simulation lab teaching activities (single breast silicone model without any actors). The only new introduction to the curriculum is an educational video on the technique of CBE."
16107314|NCT02109159|Other|A short online video with less emotional content|
16104995|NCT02125474|Radiation|[177Lu] DOTA-TATE|We have designed a one-arm phase II prospective sequential clinical trial to assess the therapeutic efficacy of 177-Lu-[DOTA 0, Tyr 3] octreotate (177-Lu- DOTATATE) applied intravenously in three separate doses to patients with inoperable progressive WDNET.
16104996|NCT02125461|Drug|MEDI4736|MEDI4736 by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier . The 2:1 ratio (MEDI4736 to placebo).
16104997|NCT02125461|Other|PLACEBO|PLACEBO by intravenous infusion. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier . The 2:1 ratio (MEDI4736 to placebo).
16104998|NCT02125448|Device|MRI and PET-CT|
16104999|NCT02125435|Drug|ASP2408|intravenous
16105000|NCT02125435|Drug|Placebo|intravenous
16105001|NCT02125422|Device|Cefaly tDCS|Cefaly tDCS (transcranial direct current stimulation) is able to modify cortical excitability, in particular anodal tDCS increases it. The side effects of tDCS are minor, especially sensations of itching and scalp paresthesias.
16105002|NCT02125409|Drug|Acetylsalicylic acid|One tablet of Adiro 100 mg will be administered daily for 7 days.
16105003|NCT02125409|Procedure|Screening colonoscopy|
16105004|NCT02125396|Other|Transarterial chemoembolization|Adjuvant transarterial chemoembolization [5-15 ml lipiodol 5-fluorouracil (500 mg/m2) and adriamycin (30 mg/m2)]
16105005|NCT02125396|Other|Radiotherapy|Adjuvant radiotherapy is used for postoperative curative HCC
16105006|NCT02125383|Procedure|Active tDCS|Anodal tDCS will be applied over motor cortex for 20 minutes, three times during the night while the subject sleeps, each separated by 1 hour
16105007|NCT02125383|Procedure|Sham tDCS|Sham tDCS will be applied over motor cortex for 20 minutes, three times during the night while the subject sleeps, each separated by 1 hour
16105008|NCT02125370|Other|Qualitative and survey|
16105009|NCT02125357|Drug|Abiraterone acetate|Abiraterone acetate 1000mg PO OD with prednisone 5mg PO BID or 10mg OD as per standard of care.
16105010|NCT02125357|Drug|Enzalutamide|160mg PO OD as per standard of care.
16105011|NCT02125344|Drug|non-pegylated liposomal doxorubicin|20 mg/m2, i.V. 18 times weekly
16105012|NCT02125344|Drug|Carboplatin|Carboplatin AUC 1.5 18 times weekly (only in patients with triple-negative breast cancer).
16105013|NCT02125344|Drug|Paclitaxel|paclitaxel 80mg/m² 18 times weekly
16105014|NCT02125344|Drug|Epirubicin|150mg/m² every 2 weeks for 3 cycles.
16105015|NCT02125344|Drug|Cyclophosphamide|2000 mg/m² every 2 weeks for 3 cycles.
16105016|NCT02125344|Drug|Pertuzumab|420 (840) mg every 3 weeks simultaneously to all T and C cycles in the ETC arm and to all cycles in the PM(Cb) arm.
16105017|NCT02125344|Drug|Trastuzumab|Trastuzumab 6 (8) mg/kg every 3 weeks simultaneously to all T and C cycles in the ETC arm and to all cycles in the PM(Cb) arm.
16105018|NCT02125344|Drug|Ferric carboxymaltose|after first anemia grade ≥2 and in case of randomisation: Ferric carboxymaltose i.V. 1000 mg followed 1 week later by an injection of ferric carboxymaltose i.V. 500 mg (if body weight is <70 kg) or 1000 mg (if body weight is ≥70 kg). In case body weight is <50 kg, both dosages will be reduced to 500 mg each.
16105019|NCT02125331|Procedure|Device: Blood pressure monitoring with GE Healthcare CARESCAPE B650 Patient Monitor-Patient Side Module (PSM) or Patient Data Module (PDM)|3-15 Non-Invasive Blood Pressure readings on the CARESCAPE B650 Patient Monitor equipped with PSM-Datex-Ohmeda and PDM-SuperSTAT NIBP measurement devices during non-emergent heart catheterization
16105020|NCT02125318|Drug|Anagrelide CR|Starting dose of 0.5 mg b.i.d. (1.0 mg/day) titrated at weekly intervals, on an individual basis, to achieve the lowest dose required to achieve and maintain a target platelet count of 150 - 400 x 10e9/L, tolerability permitting. The dose will be increased at weekly intervals in steps not exceeding 0.5 mg/day; the rate of dose titration may be reduced (i.e., up to once every 2 weeks) at the discretion of the Investigator.
16105021|NCT02125305|Drug|Metformin|
16105022|NCT02125292|Drug|Mesalamine|
16105023|NCT02125279|Drug|Calcitriol|
16105024|NCT02125266|Drug|V404|Sustained Release
16105025|NCT02125253|Drug|Mometasone Furoate Nasal Spray, 50 mcg|a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate
16105026|NCT02125253|Drug|Nasonex Nasal Spray, 50 mcg|a metered-dose, manual pump spray unit containing an aqueous suspension of mometasone furoate monohydrate
16105027|NCT02125253|Drug|Placebo Nasal Spray|a metered-dose, manual pump spray unit containing an aqueous suspension
16105028|NCT02125240|Drug|Icotinib|125 mg three times daily (375 mg per day) by mouth
16105029|NCT02125240|Drug|Placebo|1 tablet three times daily by mouth
16105030|NCT02125227|Drug|Rosuvastatin, Metformin, YH14755|single dose
16105031|NCT02125227|Drug|YH14755|single dose
16105032|NCT02125214|Device|Target Controlled Infusion system (Orchestra Base Primea, Fresenius, France)|Intravenous induction with propofol using the pharmacokinetic model by Schnider et al. The initial cerebral concentration will be 0.5 µg ml-1, which will be increased stepwise by 1.0 µg ml-1 until 2.5 µg ml-1, and then by 0.5 µg ml-1 until loss of consciousness
16105033|NCT02125201|Drug|Fentanyl|A neonate will recieve Fentanyl intranasal or intravenous 5 minutes before the procedure The nurse will check his pain scale If the pain scale will be more than 4 the neonate will recieve the second dose of Fentanyl
16105034|NCT02125188|Drug|Desmopressin|Desmopressin 3ug/kg ivdrip before surgery
16105035|NCT02125188|Drug|saline|saline 100ml ivdrip before surgery
16105036|NCT02125175|Radiation|Hypofractionated IMRT boost Radiotherapy|
16105037|NCT02125162|Drug|BCX4161|Each subject will receive Treatments A, B, and C in an open-label, randomized sequence with a washout period of at least 7 days between each dose
16105038|NCT02125149|Other|Exercise Intervention|
16105039|NCT02125136|Drug|Gem/nab-Pac|"All patient receive:
~2 cycles gemcitabine/nab-paclitaxel ([Gem/nab-Pac]; duration of each cycle 28 days)
~Then:
~Nab-paclitaxel 125 mg/m2, IV infusion over 30 minutes, followed by gemcitabine 1000 mg/m2 as a 30-minute IV infusion on D1, D8, D15 of each 28-day cycle"
16105080|NCT02124785|Procedure|Blood sampling|At Years 21 to 25 after their second vaccine dose.
16105081|NCT02124772|Drug|Trametinib|Trametinib was administered orally, once daily. It was available in tablets (0.125 mg, 0.5 mg, 2 mg dose) as well as in powder form for oral solution (0.05 mg/mL dose).
16107352|NCT02108847|Drug|Saline|
16105040|NCT02125136|Drug|FOLFIFINOX|"All patient receive:
~2 cycles gemcitabine/nab-paclitaxel ([Gem/nab-Pac]; duration of each cycle 28 days)
~Then:
~Oxaliplatin 85 mg/m2, given as a 2-hour intravenous infusion D1 Folinic acid 400 mg/m2, given as a 2-hour intravenous infusion D1 Irinotecan 180 mg/m2, given as a 90-minutes intravenous infusion D1 (application through a Y-connector parallel to infusion of folinic acid or 30 minutes after start of folinic acid possible) Fluorouracil 400 mg/m2, administered by intravenous bolus, followed by a continuous intravenous infusion of fluorouracil 2400 mg/m2 over a 46-hour period D1.
~To be repeated on D1 of each cycle."
16105041|NCT02125123|Other|Nutritional Supplement and Counseling|Ready-to-feed nutritional supplement and dietary counseling
16105042|NCT02125123|Other|Counseling|Dietary counseling
16105043|NCT02125110|Device|MRI|
16105044|NCT02125110|Other|neuropsychological assessment|
16105045|NCT02125097|Device|Barrel™ Vascular Reconstruction Device (VRD)|Intended for use with embolic coils for the treatment of wide-neck bifurcating or branch intracranial aneurysms arising from a parent vessel with a diameter of ≥ 2.0 mm and ≤ 4 mm, measured by 2D Digital Subtraction Angiography (DSA). Wide-neck is defined as having a neck width ≥ 4 mm or a dome-to-neck ratio < 2.
16105046|NCT02125084|Drug|Everolimus|
16105047|NCT02125084|Drug|Enzalutamide|
16105048|NCT02125071|Other|Blood Sample Collection|Blood Sample Collection before and after the administration of I.V. Hepabig Inj. on LT day(0 day); 1 day after; 1, 4, 12 and 24 weeks after LT.
16105049|NCT02125058|Procedure|Transcutaneous sutures|Conventional excision followed by subcutaneous sutrues and transcutaneous sutures
16105050|NCT02125058|Procedure|Intracutaneous sutures|Conventional excision followed by subcutaneous sutrues and intracutaneous sutures
16105051|NCT02125045|Dietary Supplement|L-GSH|Reduced glutathione is formed by cysteine, glycine and glutamate. It enters into the detoxification processes of endogenous products, such as peroxides which are the final pathway of many reactions caused by cardiovascular risk factors. It also acts on the exogenous compounds, such as pollutants, heavy metals and some drugs.
16105052|NCT02125045|Dietary Supplement|Placebo|Placebo will be prepared using the same excipients of the dietary supplement without active substance.
16105053|NCT02125032|Device|Transcranial low voltage pulsed electromagnetic fields (T-PEMF)|
16105054|NCT02125032|Device|Placebo Transcranial low voltage electromagnetic fields|
16105055|NCT02125006|Behavioral|Mindfulness-Based Stress Reduction|Consists of eight weekly 2.5 hour sessions and one 6 hour session midway through the course. All sessions will be conducted by a psychologist or social worker with experience in chronic pain, formal MBSR training and 5 years of experience leading MBSR groups. To assess therapist adherence to the protocol, sessions will be recorded. A random selection of 50% of sessions will be rated by an MBSR trainer who completed the University of Massachusetts Centre for Mindfulness in Medicine, Health Care and Society Teacher Development Intensive using a checklist of specified treatment components. A percentage score for each session rated will be calculated to determine therapist adherence.
16105056|NCT02124993|Other|Questionnaire|Dr. Ballanger's office will administer a FPQ upon approval of an informed consent. Subjects will be asked to complete the questionnaire at a pre-operative visit and six weeks post-operatively.
16105057|NCT02124980|Behavioral|Recovery Line|
16105058|NCT02124967|Other|Exercise|A one hour exercise class including both aerobic activity and resistance training
16105059|NCT02124954|Drug|TA-8995|
16105060|NCT02124954|Drug|Midazolam|
16105061|NCT02124954|Drug|Digoxin|
16105062|NCT02124941|Drug|N-acetyl cysteine|Upon completion of baseline (abstinence) 1H-MRS scanning, CU and HC subjects will participate in two additional 1H-MRS scans, including after 2 weeks of placebo and 2 weeks of NAC administration (3600 mg/day) given in double-blind, randomized, counterbalanced order.
16105063|NCT02124941|Diagnostic Test|[18F]FDG PET scan|All subjects will undergo [18F]FDG PET to establish previously demonstrated reductions in glucose utilization in PFC and assess VS/nucleus accumbent metabolism at baseline.
16105064|NCT02124941|Diagnostic Test|1H MRS|All subjects will undergo three magnetic resonance spectroscopy (1H-MRS) scans at 7T, including before and after two-weeks of placebo and NAC administration.
16105065|NCT02124941|Diagnostic Test|[11C]APP311 PET scan|All subjects will undergo [11C]APP311 PET imaging to investigate whether there are differences in synaptic integrity / neuronal plasticity in the brains of individuals abstinent from cocaine compared to healthy controls at baseline.
16105066|NCT02124928|Procedure|Carotid endarterectomy|Carotid endarterectomy is a surgery used to reduce the risk of stroke, by correcting stenosis in the carotid artery. Endarterectomy is the removal of material on the inside (end-) of an artery.An incision is made on the midline side of the Sternocleidomastoid muscle. The incision is between 5 and 10 cm in length. Then the patients get 5000 IU heparin by the anesthesia. The internal, common and external carotid arteries are carefully identified, controlled with vessel loops, and clamped. The lumen of the internal carotid artery is opened, and the atheromatous plaque removed. The artery is closed using suture. The procedure is performed under local anesthesia. Local anesthesia, opposite to general, allows for direct monitoring of neurological status by intra-operative verbal contact and testing of grip strength.
16105067|NCT02124902|Drug|Docetaxel|
16105068|NCT02124902|Drug|Carboplatin|
16105069|NCT02124902|Procedure|FDG-PET/MR|"Prior to initialization of Cycle 1 and completion of cycle 1 (preferably on cycle 2 day 1)
~This is not optional for final 30 participants enrolled on the study"
16105070|NCT02124889|Behavioral|Weekly Internet surveys|Subjects will receive weekly Internet surveys asking them how their treatment is working, how often they took the medication, and how easy it was to use the medication.
16105071|NCT02124863|Device|Intrapulmonary Percussive Ventilation|20 min IPV freq 300/min, p 10cmH2O
16105072|NCT02124850|Drug|Motolimod|
16105073|NCT02124850|Drug|Cetuximab|
16105074|NCT02124850|Drug|Nivolumab|
16105075|NCT02124837|Behavioral|Park walk during lunch break|
16105076|NCT02124837|Behavioral|Relaxation during lunch break|
16105077|NCT02124824|Drug|BQ-123|Endothelin subtype A antagonist
16105078|NCT02124811|Drug|Minocycline|
16105079|NCT02124798|Device|Belimumab autoinjector|Single use, disposable autoinjector assembled with the prefilled syringe containing the drug product belimumab with unit dose strength of 200mg/mL and 1 mL will be given as a once weekly SC dose
16107395|NCT02108548|Drug|Placebo|oral
16105082|NCT02124772|Drug|Dabrafenib|Dabrafenib was administered orally, twice daily. The daily dose was divided into two equal doses. It was available in capsules (50 mg and 75 mg), dispersible tablets (10 mg) and powder for oral suspension (10 mg/mL dose).
16105083|NCT02124759|Drug|Sevelamer|1.6 g sevelamer + 4.4 g maltodextrin three times a day
16105084|NCT02124759|Drug|Synbiotic|5 g of oligofructose + 1 g Bifidobacterium longum R0175 (4 billion colony forming units (CFU)/g) three times a day.
16105085|NCT02124759|Drug|Maltodextrin|This is a control group. Maltodextrin, 6 g three times a day
16105086|NCT02124759|Other|High Fat diet|The High Fat diet consists of 60% energy from fat (50% saturated), 15% of energy as carbohydrate and 25% from protein consumed while study intervention is being administered.
16105087|NCT02124759|Other|Low Fat diet|The isocaloric low fat diet will provide 55% energy from carbohydrates, 20% from fat and 25% from protein.
16105088|NCT02124746|Drug|Momelotinib|Momelotinib tablets administered orally once daily
16105089|NCT02124733|Procedure|Aminolevulinic acid based photodynamic therapy|The PDT treatments will be done in two stages. ALA (Levulan® Kerastick™) will be applied to the entire treatment area, and then the longer light exposure (lasting up to 1 hr) will be performed on one-half of the treatment area (Side A). After that, a shorter (16 min 40 sec) light exposure will be done on the other half (Side B).
16105090|NCT02124720|Behavioral|iSTIM|Trained research assistants and parents will implement the assessments and interventions recommended by the iSTIM mobile application during sessions lasting between 10 and 60 minutes
16105091|NCT02124707|Drug|Cetuximab|400mg/m2 IV (in the vein) on day 1 of week 1 and 250mg/m2 IV (in the vein) on day 1 of weeks 2-6. Patients with stable disease may continue on maintenance therapy at the 250mg/m2 dose until disease progression.
16105092|NCT02124707|Drug|Paclitaxel|135mg/m2 IV (in the vein) on day 1 of each 1 week for 6 weeks.
16105093|NCT02124707|Drug|Carboplatin|AUC2, IV (in the vein) on day 1 of each 1 week for 6 weeks.
16105094|NCT02124694|Behavioral|HTUG|HTUG is a group psychotherapy...
16105095|NCT02124681|Drug|Hydroxychloroquine|Hydroxychloroquine sulfate 400mg/d PO for 13±1 weeks
16105096|NCT02124681|Other|Placebo|Placebo PO for 13±1 weeks
16105097|NCT02124668|Drug|Enzalutamide|oral
16105098|NCT02124655|Drug|Essential oils|
16105099|NCT02124655|Drug|0.2% chlorhexidine|
16105100|NCT02124655|Drug|Sterile water|
16105101|NCT02124642|Dietary Supplement|Folic acid, 400 mcg/day|The supplement regime for this arm will consist of (1) a women's multivitamin/ multimineral (MVM) supplement containing 400 mcg folic acid, (2) a capsule containing 200 mg DHA and (3) a capsule formulated to contain 10 mg iron (which represents the difference in the amount of iron in the women's MVM formulation and that in prenatal MVM supplements).
16105102|NCT02124642|Dietary Supplement|Folic acid 800 mcg/day|The supplement regime for this arm will consist of (1) a women's multivitamin/ multimineral (MVM) supplement containing 400 mcg folic acid, (2) a capsule containing 200 mg DHA and (3) a capsule formulated to contain 10 mg iron (which represents the difference in the amount of iron in the women's MVM formulation and that in prenatal MVM supplements) and 400 mcg folic acid.
16105103|NCT02124590|Other|Acute Exercise|Repeated isometric leg exercises at varying intensities for up to twelve minutes per bout. Leg exercises will target the quadriceps muscles.
16105104|NCT02124590|Other|Acute Exercise|Aerobic exercise session on a bike at 50% of peak VO2 for 30 minutes.
16105105|NCT02124564|Drug|Lacosamide|"Lacosamide (LCM) immediate-release, film-coated tablets at a strength of 50 mg orally administered twice daily in two equally divided doses.
~4-week Titration Period: Starting on LCM 100 mg/day increased by 100 mg/day each week until 400 mg/day dose reached at the beginning of Week 4 .
~The AED Withdrawal Period and Monotherapy Period (52- week Evaluation Period plus a Follow Up Period): During the AED Withdrawal and Monotherapy Period, the investigator may increase or decrease the dose of LCM to optimize tolerability and seizure control. The LCM dose may be decreased no lower than 200 mg/day or increased, no faster than 100 mg/day per week, up to 600 mg/day."
16105106|NCT02124525|Drug|N-acetylcysteine|N-acetylcysteine 3000mg a day for 12 weeks versus Placebo for 12 weeks
16105107|NCT02124512|Drug|Rifaximin SSD|Study Drug dosing will be 80 mg SSD once daily
16105108|NCT02124512|Other|Placebo|80 mg placebo once daily
16105109|NCT02124486|Procedure|Bariatric surgery|Participants randomised to the bariatric surgery arm of the trial will be referred to the surgery pathway according to NICE guidelines at Birmingham Heartlands Hospital (BHH), Heart of England NHS Foundation Trust.
16105110|NCT02124486|Behavioral|Dietetic intervention|Participants randomised to the dietetic arm will be given vouchers at baseline, 3, 6 and 9 months that exempt them from paying for consecutive and specified weeks of their local Weight Watchers.
16105111|NCT02124473|Other|Homeopathy|
16105112|NCT02124473|Other|Placebo|
16105113|NCT02124460|Behavioral|Health Coaching|"Parent/child duos enrolled in the intervention group will participate in a total of six visits with a trained health coach. During these visits, the health coach will coach the parent/child duos on improving obesity-related behaviors .
~The health coach will also help the family identify supports to assist with behavior change; discuss family health habits and the home environment; and review and encourage use of materials related to both specific target behaviors and available resources in the community.
~Following the first call with the health coach, parents will receive semi-weekly text messages designed by the study team. The messages will alternate in structure between 2 types of messages; 1) skills training messages will deliver tips and motivational messages to help their child practice the study's goals and 2) self monitoring messages will ask parents to respond to the message and track health behaviors important to this study."
16105114|NCT02124447|Drug|PEG+E|Split dose 4 liter polyethylene glycol with electrolytes
16105115|NCT02124447|Drug|PEG+Asc|Split dose 2 liter polyethylene glycol with ascorbic acid
16105116|NCT02124447|Drug|P+MC|Split dose sodium picosulfate, magnesium oxide, and anhydrous citric acid
16105117|NCT02124447|Drug|sulfate|Split dose sodium sulfate, magnesium sulfate, and potassium sulfate solution
16105118|NCT02124421|Procedure|Cytoreductive Surgery (CRS)|Cytoreductive surgery
16105119|NCT02124421|Drug|Adjuvant Chemotherapy|Six weeks post-surgery (CRS or CRS/HIPEC) standard combination chemotherapy will be administered every 21 days for 6 cycles
16105120|NCT02124421|Other|Questionnaire|Questionnaires designed to assess quality of life in ovarian cancer patients will be administered to study participants
16105121|NCT02124421|Procedure|Hyperthermic intraperitoneal chemotherapy|Hyperthermic intraperitoneal chemotherapy with carboplatin, AUC=6
16105122|NCT02124421|Drug|Carboplatin|AUC=6 mg/mL/min IV (in the vein), on day 1. Repeat every 21 days for 6 cycles.
16105123|NCT02124421|Drug|Paclitaxel|175 mg/m2 IV (in the vein), day 1. Repeat every 21 days for 6 cycles
16105124|NCT02124421|Drug|Paclitaxel|Day 1: paclitaxel 135 mg/m2 IV (in the vein). Repeat every 21 days for 6 cycles Day 8: paclitaxel 60 mg/m2 IP (intraperitoneal). Repeat every 21 days for 6 cycles
16105125|NCT02124421|Drug|Cisplatin|Day 2: cisplatin 75 mg/m2 IP (intraperitoneal). Repeat every 21 days for 6 cycles
16105126|NCT02124408|Behavioral|Personalized Behavioral Intervention|
16105127|NCT02124395|Other|Health-related Quality of Life in Rare Kidney Stone Questionnaire|
16105128|NCT02124369|Drug|Abraxane|125mg/m2, IV, on days 1,8 & 15 of each 28 day cycle, up to 6 cycles.
16105129|NCT02124369|Drug|Gemcitabine|1000mg/m2, IV, on days 1,8 & 15 of a 28 day cycle, up to 6 cycles.
16105130|NCT02124356|Other|Evaluation of functional performance|
16105131|NCT02124343|Other|Interval Exercise|
16105132|NCT02124330|Dietary Supplement|montmorillonite 5 g|5g montmorillonite + 15 g protein (ratio 1:3)
16105133|NCT02124330|Dietary Supplement|montmorillonite 3 g|3g MONT+ 15 g protein (ratio 1:5)
16105134|NCT02124330|Dietary Supplement|Montmorillonite 1 g|1g MONT+ 15 g protein (ratio 1:15)
16105135|NCT02124317|Drug|nanoparticle albumin-bound paclitaxel|nanoparticle albumin-bound paclitaxel is given at 120 mg/m2 intravenously on day 1 and 8 of each 21 day cycle. Number of cycles: 6 cycles.
16105136|NCT02124317|Drug|S-1|S-1 is orally administered (40-60 mg according to the body surface, twice a day) on day 1-14 of each 21 day cycle. Number of cycles: 6 cycles.
16105137|NCT02124304|Device|Neck exercises using both manual and Thera-Band elasatic resistance|Exercises will include cervical flexion and extension, and cervical right and left side-bending, and rotation. All 6 exercises will be done with both manual and elastic (Thera-Band) resistance.Manual Resistance is applied by the subject placing their own hand on their head and pushing in to it. Thera-Band bands will be used to provide elastic resistance
16105138|NCT02124291|Device|Mechanical Assisted Hatching|The technique of assisted hatching using partial zona pellucida dissection to create an artificial opening of the zona pellucida of early cleaved embryos. While the embryo is stabilized by a holding pipette of micromanipulator, the zona pellucida is pierced with a microneedle that is pushed tangentially through the space between the zona pellucida and blastomeres until it pierces through the zona pellucida again.
16105139|NCT02124278|Drug|PUL-042 Inhalation Solution|
16105140|NCT02124265|Drug|CeraLyte 90|"This is a prospective pilot study of patients with moderate-major burn wounds (20-65% TBSA).
~Patients who meet inclusion/exclusion criteria will be enrolled in the study upon admission to the Burn Unit.
~Fluid requirements will be calculated according to the Parkland Formula (4 cc/kg/% Total Body Surface Area) administered over 24 hours since time of injury.
~5. Patients will be monitored according to standard of care.
~a. If gastric residuals are >300cc, ORT will be stopped and only IV fluid resuscitation will be used."
16105141|NCT02124252|Behavioral|Community-based testing with standard linkage to care|Women will be offered HPV-based cervical cancer screening followed by standard linkage to care for women who test positive (to subdistrict or district hospitals).
16105142|NCT02124252|Behavioral|Community-based HPV testing with enhanced linkage to care|Women will be offered HPV-based cervical cancer screening followed by enhanced linkage to care using the strategies determined in partnership with the key stakeholders in the communities.
16105143|NCT02124239|Drug|Ingenol mebutate|
16105144|NCT02124226|Drug|Methotrexate|7.5 mg/week + folic acid the day after
16105145|NCT02124226|Drug|Placebo|matched placebo
16105146|NCT02124213|Drug|30 mg PF-06412562|Subject will receive a single dose of 30 mg PF-06412562
16105147|NCT02124213|Drug|PF-06412562|The dose will be selected based on the results obtained for Cohort 1. This Cohort is optional.
16105148|NCT02124213|Drug|PF-06412562|"The dose will be selected based on the results obtained for Cohort 1 and Cohort 2.
~This Cohort is optional."
16105149|NCT02124200|Device|EGO/CE4, 9mg nicotine|
16105150|NCT02124187|Device|Ecig 24 mg nicotine|eCig 24 mg nicotine for 12 weeks
16105151|NCT02124187|Device|Ecig 0 mg nicotine|eCig 0 mg nicotine for 12 weeks
16105152|NCT02124187|Device|Nicotine free inhalator|eCig 24 mg nicotine for 12 weeks
16105153|NCT02124174|Drug|Vidaza and Valproic Acid|"Days 1-5: 5-Azacytidine 40 mg/m^2 daily Days 1-5: +Valproic acid 15 mg/kg daily Days 6-28: Valproic acid 15 mg/kg daily
~*treatments will be repeated on the same days of each cycle for up to 4 total cycles. Each cycle will consist of 28 days."
16105154|NCT02124161|Biological|13-valent pneumococcal conjugate vaccine|One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.
16105155|NCT02124161|Biological|Seasonal Inactivated Influenza Vaccine|One (1) dose of SIIV will be administered intramuscularly into the right deltoid of all subjects at Visit 1.
16105156|NCT02124161|Other|Placebo|One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.
16105157|NCT02124161|Other|Placebo|One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.
16105158|NCT02124161|Biological|Seasonal Inactivated Influenza Vaccine|One (1) dose of SIIV will be administered intramuscularly into the right deltoid of all subjects at Visit 1.
16105159|NCT02124161|Biological|13-valent pneumococcal conjugate vaccine|One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.
16105160|NCT02124148|Drug|Prexasertib|Administered IV
16105161|NCT02124148|Drug|Cisplatin|Administered IV
16105162|NCT02124148|Drug|Cetuximab|Administered IV
16105163|NCT02124148|Drug|G-CSF|Administered SC
16105164|NCT02124148|Drug|Pemetrexed|Administered IV
16105165|NCT02124148|Drug|Fluorouracil|Administered IV
16105166|NCT02124148|Drug|LY3023414|Administered PO
16105167|NCT02124148|Drug|Leucovorin|Administered IV
16105359|NCT02123082|Device|Dual Lumen Ureteroscope|Dual lumen, flexible scope for ureteroscopies
16105168|NCT02124135|Behavioral|Diet/Nutrition Education|"As described elsewhere, all participants will receive 1 phone call and 3 in person sessions with the registered dietitian.
~Participants in the clinic arm will receive the education intervention in the clinic.
~Participants in the restaurant arm will receive the education intervention while dining in a restaurant."
16105169|NCT02124122|Biological|Lactobacillus reuteri|Probiotic
16105170|NCT02124122|Biological|Placebo|Placebo
16105171|NCT02124083|Drug|Vorinostat|Histone deactylase inhibitor
16105172|NCT02124070|Drug|rh Growth Hormone|
16105173|NCT02124044|Drug|Asunaprevir and Daclatasvir|Oral treatment with Asunaprevir 100mg (ASV), twice daily, and Daclatasvir 60mg (DCV), once daily, for 24 weeks in HIV/HCV genotype 1b patients
16105174|NCT02124044|Drug|Asunaprevir and Daclatasvir with BMS-791325|Oral treatment with Asunaprevir 200mg (ASV), Daclatasvir 30 mg (DCV) and BMS-791325 75 mg in a fixed dose combination pill (FDC), twice daily, for 12 weeks in HIV/HCV genotype 1a or 1b patients
16105175|NCT02124018|Procedure|Programmed ventricular stimulation|Programmed ventricular stimulation in high-risk patients based on non-invasive evaluation
16105176|NCT02124018|Device|ICD implantation|ICD implantation in patients with induced VT in programmed ventricular stimulation
16105177|NCT02124005|Drug|Bupivacaine|
16105178|NCT02123992|Device|Elevate Apical and Posterior|
16105179|NCT02123992|Procedure|Native Tissue Repair for pelvic organ prolapse|
16105180|NCT02123979|Drug|Neupro® transdermal patch/placebo|8mg transdermal patch Neupro® transdermal patch/placebo
16105181|NCT02123966|Drug|Sirolimus|
16105182|NCT02123953|Drug|TAK-438|TAK-438 tablets
16105183|NCT02123953|Drug|TAK-438 Placebo|TAK-438 placebo-matching tablets
16105184|NCT02123940|Device|lung ultrasound score|Prospective randomized clinical multicentric study on ICU comparing a treatment strategy (nasal humidified high flow therapy and Noninvasive Ventilation) in patients with high-risk of postextubation distress in ICU based on a Lung Ultrasound Score VERSUS standard strategy
16105185|NCT02123927|Drug|TAK-438|TAK-438 tablets
16105186|NCT02123927|Drug|Placebo|TAK-438 placebo-matching tablets
16105187|NCT02123914|Other|Aerobic exercise with Vit. C|"walking - running on a treadmill at intensity of 65-70% HRR for 30 minutes per session three times a week combined with taking vitamin C supplemented daily with an oral dose of 2,000 mg 2 times/day for 8 weeks.
~Nasal challenge with house dust mites with the evaluation of cytokines in nasal lavage fluid,
~Nasal peak flow measurement,
~Nasal blood flow measurement,
~Exercise training regimen including VO2max measurment at baseline and at the end of the experiment."
16105188|NCT02123914|Other|Aerobic exercise|"walking - running on a treadmill at intensity of 65-70% HRR for 30 minutes per session three times a week for 8 weeks.
~Nasal challenge with house dust mites with the evaluation of cytokines in nasal lavage fluid,
~Nasal peak flow measurement,
~Nasal blood flow measurement,
~Exercise training regimen including VO2max measurment at baseline and at the end of the experiment."
16105189|NCT02123914|Other|No exercise|"Sedentary control.
~Nasal challenge with house dust mites with the evaluation of cytokines in nasal lavage fluid,
~Nasal peak flow measurement,
~Nasal blood flow measurement,
~Exercise training regimen including VO2max measurment at baseline and at the end of the experiment."
16105190|NCT02123901|Other|Walking Meditation|"Walking Meditation training program will be based on aerobic walking exercise combined with Buddhist meditation. The subjects will perform walking on the treadmill while concentrated on foot stepping by voiced Budd and Dha with each foot step that contacted the floor to practice mindfulness while walking. Walking Meditation will be conducted at mild to moderate intensity (50-60% maximum heart rate) and in phase 2 (week 7-12), the training intensity will be increased to moderate intensity (60-70% maximum heart rate). In both phases the training will be performed for 30 minutes, 3 times per week."
16105191|NCT02123901|Other|Walking|Walking training program will be based on aerobic walking exercise. The subjects will perform walking on the treadmill and conducted at mild to moderate intensity (50-60% maximum heart rate) and in phase 2 (week 7-12), the training intensity will be increased to moderate intensity (60-70% maximum heart rate). In both phases the training will be performed for 30 minutes, 3 times per week.
16105192|NCT02123901|Other|No exercise|Sedentary life style.
16105193|NCT02123888|Radiation|Cone Beam Computed Tomography|Simultaneous Cone Beam Computed Tomography acquisition during arc radiotherapy
16105194|NCT02123875|Other|Physiotherapy|
16105195|NCT02123875|Other|Control arm|Routine hospital based physiotherapy
16105196|NCT02123849|Drug|Aspirin|Given PO
16105197|NCT02123849|Other|Laboratory Biomarker Analysis|Correlative studies
16105198|NCT02123849|Other|Placebo|Given PO
16105199|NCT02123836|Biological|NK cells|"7 days of preparatory treatment are given before the NK cell infusion. Chemotherapy will be given over 6 days. This chemotherapy will promote donor NK cells engraftment. After which, a drug called Interleukin-2 (IL-2) will be given as an injection just under the skin three times per week for at least 2 weeks (total of 6 doses). This treatment is used to help keep the donor NK cells alive.
~Blood cells will be collected from an eligible and suitable family donor 10 days before infusion. The collection sample will be processed to remove red blood cells and as many T-cells as possible. T-cells from the donor might cause these donor cells to attack the body, usually the skin, liver, and intestines.
~NK cells will be activated in the National University Hospital lab and ready for infusion on Day 0.
~The NK cells will then be infused into the vein, through a peripheral catheter."
16105200|NCT02123823|Drug|Everolimus|10mg dose
16105201|NCT02123823|Drug|Everolimus|at recommended dose as per Phase I data
16105202|NCT02123823|Drug|Everolimus|Dose escalation (24-48 patients) in Phase I. 3 dose levels depending on the dose cohort explored: 5mg, 7,5mg and 10mg
16105203|NCT02123823|Drug|Exemestane|Fixed dose at 25mg
16105204|NCT02123823|Drug|BI 836845|Human monoclonal antibody at recommended dose as per Phase I data
16105205|NCT02123823|Drug|BI 836845|Human monoclonal antibody. Dose escalation (24-48 patients) in Phase I. 2 dose levels (high or low) depending on the dose cohort explored
16105206|NCT02123823|Drug|Exemestane|Fixed dose at 25mg
16105207|NCT02123823|Drug|Exemestane|Fixed dose at 25mg
16105208|NCT02123810|Other|CPR|Simulated cardiac arrest on a manikin Chest Compression CPR for 6 minutes
16105257|NCT02123615|Drug|Efficacy of Gammagard subdermally at Week 36|(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
16105209|NCT02123758|Drug|Abiraterone Acetate|Administered orally (by mouth) once daily in morning at a dose of 1000 mg for up to the end of treatment (EoT) visit (ie, for up to approximately 18 months).
16105210|NCT02123758|Drug|Prednisone|Administered orally twice a day at a dose of 5mg for up to the end of treatment (EoT) visit (ie, for up to approximately 18 months).
16105211|NCT02123758|Drug|JNJ-56021927|Administered orally once daily in morning at a dose of 240 mg starting on Day 8, Treatment Cycle 1 for up to the end of treatment (EoT) visit (ie, for up to approximately 18 months).
16105212|NCT02123745|Device|The ivWatch Model 400|The ivWatch Model 400 monitored the site during the course of the infiltration and issued red and/or yellow notifications if an infiltration was detected.
16105213|NCT02123732|Dietary Supplement|DbXell|
16105214|NCT02123732|Dietary Supplement|Placebo|
16105215|NCT02123719|Other|Surgery|
16105216|NCT02123693|Other|Osteopathic manipulative treatment|
16105217|NCT02123693|Other|Sham Therapy|
16105218|NCT02123693|Other|No Intervention|
16105219|NCT02123654|Drug|Daclatasvir|
16105220|NCT02123654|Drug|Asunaprevir|
16105221|NCT02123654|Drug|DCV 3DAA|
16105222|NCT02123654|Other|Placebo for DCV 3DAA|
16105223|NCT02123654|Other|Placebo for Daclatasvir|
16105224|NCT02123654|Other|Placebo for Asunaprevir|
16105225|NCT02123641|Other|Heavy resistance training|Supervised heavy resistance training three times weekly for 52 weeks.
16105226|NCT02123641|Other|Moderate intensity training|Moderate intensity training supervised once weekly and home based unsupervised two times weekly for 52 weeks.
16105227|NCT02123641|Other|Control|No training
16105228|NCT02123628|Drug|duration of the antibiotic therapy|
16105229|NCT02123615|Drug|Gadolinium For abdomen|"Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subdermally with ASIS Device for 30 patients.
~Gadolinium For abdomen Total Persistent % subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs."
16105230|NCT02123615|Drug|Gadolinium For abdomen|"Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subcutaneously for 30 patients.
~Gadolinium For abdomen Total Persistent % subcutaneously on MRI at 6 hrs, 12 hrs, and 24 hrs."
16105231|NCT02123615|Drug|Gadolinium For abdomen|Gadolinium For abdomen Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI.
16105232|NCT02123615|Drug|Gadolinium For lower back|Gadolinium For lower back Total Persistent % subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs. Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subdermally with ASIS Device for 30 patients.
16105233|NCT02123615|Drug|Gadolinium For lower back|Gadolinium For lower back Total cumulative Persistent % of Gadolinium subcutaneously on MRI at 6 hrs, 12 hrs, and 24 hrs. Gadolinium 1cc/ diluted with 19cc normal saline (for <40kg) or 29cc normal saline (for >40kg) subcutaneously for 30 patients.
16105234|NCT02123615|Drug|Gadolinium For lower back|Gadolinium For lower back Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI .
16105235|NCT02123615|Drug|Efficacy of Gammagard subcutaneously at Week 12|subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 12.
16105236|NCT02123615|Drug|Efficacy of Gammagard subcutaneously at Week 12|Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 12.
16105237|NCT02123615|Drug|Efficacy of Gammagard subcutaneously at Week 12|subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
16105238|NCT02123615|Drug|Efficacy of Gammagard subcutaneously at Week 12|Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 12.
16105239|NCT02123615|Drug|Efficacy of Gammagard subcutaneously at Week 12|subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
16105240|NCT02123615|Drug|Efficacy of Gammagard subcutaneously at Week 12|Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 12.
16105241|NCT02123615|Drug|Efficacy of Gammagard subcutaneously at Week 12|(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
16105242|NCT02123615|Drug|Efficacy of Gammagard subcutaneously at Week 12|Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 12.
16105243|NCT02123615|Drug|Efficacy of Gammagard subcutaneously at Week 24|subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 24.
16105244|NCT02123615|Drug|Efficacy of Gammagard subcutaneously at Week 24|Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 24.
16105245|NCT02123615|Drug|Efficacy of Gammagard subcutaneously at Week 24|subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
16105246|NCT02123615|Drug|Efficacy of Gammagard subcutaneously at Week 24|Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 24.
16105247|NCT02123615|Drug|Efficacy of Gammagard subcutaneously at Week 24|subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 24.
16105248|NCT02123615|Drug|Efficacy of Gammagard subcutaneously at Week 24|Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 24
16105249|NCT02123615|Drug|Efficacy of Gammagard subcutaneously at Week 24|(%) with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
16105250|NCT02123615|Drug|Efficacy of Gammagard subcutaneously at Week 24|Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 24.
16105251|NCT02123615|Drug|Efficacy of Gammagard subcutaneously at Week 36|subjects (%) of any infections as Efficacy of Gammagard subcutaneously at Week 36.
16105252|NCT02123615|Drug|Efficacy of Gammagard subcutaneously at Week 36|Annual rate of any infections as Efficacy of Gammagard subcutaneously at Week 36.
16105253|NCT02123615|Drug|Efficacy of Gammagard subcutaneously at Week 36|subjects (%) with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
16105254|NCT02123615|Drug|Efficacy of Gammagard subcutaneously at Week 36|Annual rate with Antibiotic use as Efficacy of Gammagard subcutaneously at Week 36.
16105255|NCT02123615|Drug|Efficacy of Gammagard subcutaneously at Week 36|subjects (%) with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
16105256|NCT02123615|Drug|Efficacy of Gammagard subdermally at Week 36|Annual rate with Days out of work as Efficacy of Gammagard subcutaneously at Week 36.
16105258|NCT02123615|Drug|Efficacy of Gammagard subdermally at Week 36|Annual rate with hospitalized infections as Efficacy of Gammagard subcutaneously at Week 36.
16105259|NCT02123615|Drug|Efficacy of Gammagard subdermally at Week 12|subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 12
16105260|NCT02123615|Drug|Efficacy of Gammagard subdermally at Week 12|Annual rate of any infections as Efficacy of Gammagard subdermally at Week 12
16105261|NCT02123615|Drug|Efficacy of Gammagard subdermally at Week 12|subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
16105262|NCT02123615|Drug|Efficacy of Gammagard subdermally at Week 12|Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 12
16105263|NCT02123615|Drug|Efficacy of Gammagard subdermally at Week 12|subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 12
16105264|NCT02123615|Drug|Efficacy of Gammagard subdermally at Week 12|Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 12
16105265|NCT02123615|Drug|Efficacy of Gammagard subdermally at Week 12|(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 12
16105266|NCT02123615|Drug|Efficacy of Gammagard subdermally at Week 12|Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 12.
16105267|NCT02123615|Drug|Efficacy of Gammagard subdermally at Week 24|subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 24.
16105268|NCT02123615|Drug|Efficacy of Gammagard subdermally at Week 24|Annual rate of any infections as Efficacy of Gammagard subdermally at Week 24.
16105269|NCT02123615|Drug|Efficacy of Gammagard subdermally at Week 24|subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
16105270|NCT02123615|Drug|Efficacy of Gammagard subdermally at Week 24|Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 24.
16105271|NCT02123615|Drug|Efficacy of Gammagard subdermally at Week 24|subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 24.
16105272|NCT02123615|Drug|Efficacy of Gammagard subdermally at Week 24|Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 24.
16105273|NCT02123615|Drug|Efficacy of Gammagard subdermally at Week 24|(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
16105274|NCT02123615|Drug|Efficacy of Gammagard subdermally at Week 24|Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 24.
16105275|NCT02123615|Drug|Efficacy of Gammagard subdermally at Week 36|subjects (%) of any infections as Efficacy of Gammagard subdermally at Week 36.
16105276|NCT02123615|Drug|Efficacy of Gammagard subdermally at Week 36|Annual rate of any infections as Efficacy of Gammagard subdermally at Week 36.
16105277|NCT02123615|Drug|Efficacy of Gammagard subdermally at Week 36|subjects (%) with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
16105278|NCT02123615|Drug|Efficacy of Gammagard subdermally at Week 36|Annual rate with Antibiotic use as Efficacy of Gammagard subdermally at Week 36.
16105279|NCT02123615|Drug|Efficacy of Gammagard subdermally at Week 36|subjects (%) with Days out of work as Efficacy of Gammagard subdermally at Week 36.
16105280|NCT02123615|Drug|Efficacy of Gammagard subdermally at Week 36|Annual rate with Days out of work as Efficacy of Gammagard subdermally at Week 36.
16105281|NCT02123615|Drug|Efficacy of Gammagard subdermally at Week 36|(%) with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
16105282|NCT02123615|Drug|Efficacy of Gammagard subdermally at Week 36|Annual rate with hospitalized infections as Efficacy of Gammagard subdermally at Week 36.
16105283|NCT02123615|Drug|Adverse Reactions of Gammagard subcutaneously at Week 12|Adverse Reactions of Gammagard subcutaneously at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
16105284|NCT02123615|Drug|Adverse Reactions of Gammagard subcutaneously at Week 24|Adverse Reactions of Gammagard subcutaneously at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
16105285|NCT02123615|Drug|Adverse Reactions of Gammagard subcutaneously at Week 36|Adverse Reactions of Gammagard subcutaneously at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
16105286|NCT02123615|Drug|Adverse Reactions of Gammagard subdermally at Week 12|Adverse Reactions of Gammagard subdermally at Week 12, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain
16105287|NCT02123615|Drug|Adverse Reactions of Gammagard subdermally at Week 24|Adverse Reactions of Gammagard subdermally at Week 24, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
16105288|NCT02123615|Drug|Adverse Reactions of Gammagard subdermally at Week 36|Adverse Reactions of Gammagard subdermally at Week 36, in number of Local Reactions, Headache, Fever, Nausea, Vomiting, Fatigue, Diarrhea, Asthma, Oropharyngeal, and Abdominal Pain.
16105289|NCT02123602|Other|core stabilization|
16105290|NCT02123602|Other|lower extremity training only|
16105291|NCT02123589|Drug|Deep sedation(midazolam and fentanyl )|0.05~0.1mg/kg midazolam and 1~2μg/kg fentanyl,IV; 0.05mg/kg.h midazolam and1~2μg/kg.h fentanyl,continuous intravenous infusion ; the target level of sedation,RASS score between -5 and -3
16105292|NCT02123589|Drug|Deep and daily interruption of sedation(midazolam and fentanyl )|0.05~0.1mg/kg midazolam and 1~2μg/kg fentanyl,IV; 0.05mg/kg.h midazolam and1~2μg/kg.h fentanyl continuous intravenous infusion ; The target level of sedation,RASS score between -5 and -3. Daily interruption of sedation will be taken from the second day after admitted in ICU
16105293|NCT02123589|Drug|Light sedation(midazolam and fentanyl )|0.05~0.1mg/kg midazolam and 1~2μg/kg fentanyl,IV; 0.05mg/kg.h midazolam and1~2μg/kg.h fentanyl,continuous intravenous infusion ; The target level of sedation,RASS score between -2 and +1;
16105294|NCT02123576|Drug|Pentoxyfylline|
16105295|NCT02123576|Drug|Placebo|
16105296|NCT02123576|Drug|AMO Therapy|Albumin, midodrine and octreotide therapy (standard of care for HRS)
16105328|NCT02123355|Procedure|Intubation|After muscle relaxed and loss of eyelash reflex of the patients, intubation is done,then mechanical ventilation is performed, and maintain the PETCO2于35~40 mmHg，pulse oxygen saturation is more than 95%.
16105360|NCT02123069|Device|Brachial artery catheter|A catheter will be placed in the brachial artery by a physician on the study day.
16105297|NCT02123563|Other|Ultrason Essential oils rinse|Test treatment strategy combined mechanical and chemical procedures. Mechanical procedures were: a) ultrasonic debridement to remove dental plaque, calculus and teeth staining; b) dental polishing and c) oral hygiene instructions related to brushing and flossing. Toothbrush, dental floss and fluoride dentifrice were monthly provided. Within the same visit participants performed at the study center the first supervised rinse. Other rinses were performed at home unsupervised. A diary card was used to register times of rinsing. Participants rinsed twice a day a commercially available non-prescription essential-oils solution (20mL, 30 seconds for each rinse) for 3 months. This solution is composed of eucalyptol 0.092%, menthol 0.042%, methyl salicylate 0.060%, thymol 0.064%, zinc chloride and sodium fluoride 0.0221%.
16105298|NCT02123563|Other|Ultrason Placebo rinse|Comparative treatment strategy combined mechanical and chemical procedures. Mechanical procedures were: a) ultrasonic debridement to remove dental plaque, calculus and teeth staining; b) dental polishing and c) oral hygiene instructions related to brushing and flossing. Toothbrush, dental floss and fluoride dentifrice were monthly provided. Within the same visit participants performed at the study center the first supervised rinse. Other rinses were performed at home unsupervised. A diary card was used to register times of rinsing. Participants rinsed twice a day a placebo solution (20mL, 30 seconds for each rinse) for 3 months.
16105299|NCT02123537|Device|Bioness L300 Foot Drop System|Participants will use the Bioness L300 Foot Drop System during waking hours for 12 weeks.
16105300|NCT02123524|Drug|Rivaroxaban|
16105301|NCT02123524|Drug|Placebo|
16105302|NCT02123511|Drug|acetylcysteine|Oral rinse
16105303|NCT02123511|Other|placebo|Oral rinse
16105304|NCT02123511|Other|quality-of-life assessment|Ancillary studies
16105305|NCT02123511|Other|questionnaire administration|Ancillary studies
16105306|NCT02123498|Drug|Omeprazole|40mg, to be taken once daily by mouth, 30-60 minutes before meals, for at least 6 weeks
16105307|NCT02123498|Drug|Ranitidine|300mg, to be taken once daily by mouth, before bedtime, for at least 6 weeks
16105308|NCT02123498|Drug|Pantoprazole|40mg, to be taken twice daily by mouth, 30-60 minutes before meals, for at least 6 weeks. (Alternative intervention if participant cannot tolerate omeprazole, is on an anticoagulant medication, or if on medication contraindicated for omeprazole and ranitidine)
16105309|NCT02123498|Procedure|24-Hour Diagnostic pH-Probe Test|Participants will undergo a routine clinical 24-hour diagnostic pH-probe test to assess quantitative measures for laryngopharyngeal reflux.
16105310|NCT02123498|Procedure|Laryngoscopy|Participants will undergo routine clinical laryngoscopy to assess presence of laryngopharyngeal reflux.
16105311|NCT02123485|Device|Low frequency (1 hz) rTMS, as add-on to ECT|Right prefrontal Low frequency (1 hz) repetitive transcranial magnetic stimulation as add-on to ECT.
16105312|NCT02123485|Device|Sham-rTMS|Right prefrontal Low frequency (1 hz) sham-stimulation using af double blind placebo coil as add-on to ECT.
16105313|NCT02123472|Drug|Cephalexin|Administered Orally
16105314|NCT02123459|Drug|Cephalexin|Administered orally
16105315|NCT02123446|Drug|Cephalexin|Administered orally.
16105316|NCT02123433|Biological|pneumococcal conjugate 13 valent vaccine|"Pneumococcal polysaccharide conjugate vaccine(13-valent adsorbed) conjugated to CRM197 carrier protein and adsorbed on aluminum phosphate (0.125 mg of aluminum).
~Pharmaceutical form: suspension for injection. Dosage: 0.5 ml, containing 2.2 g of polysaccharide for serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, and 4.4 micrograms for serotype 6B.
~Prevenar 13 is administered in two doses,each of 0.5 ml, with an interval of 2 months, injected intramuscularly in the deltoid muscle of the arm."
16105317|NCT02123420|Device|Nobel Replace Tapered Groovy implant; (Nobel Biocare®, Sweden)|"Both sites received tapered implants with an anodised surface, one site received: Nobel Replace Tapered Groovy PS implant; (Nobel Biocare, Goteborg, Sweden), with diameters of 4.3 or 5.0 mm and lengths of 10 or 8 mm, (PS group), the contralateral site received Nobel Replace Tapered Groovy implant with Replace Select connection with diameters of 4.3 or 5.0 mm and lengths of 10 or 8 mm, (RP group).
~Healing abutments were connected to implants at the same time of surgery , then flaps were sutured with Vicryl 4.0 sutures (Vicryl, Ethicon J&J International, St-Stevens-Woluwe, Belgium)."
16105318|NCT02123407|Drug|Carbon Nanoparticles|Carbon Nanoparticles will be injected into the subserosa of stomach around the tumor.Gastrectomy with D2 dissection will be performed after the injection.
16105319|NCT02123407|Procedure|Gastrectomy with D2 dissection|In the control arm,Gastrectomy with D2 dissection will be performed directly,without any coloring materials.
16105320|NCT02123394|Other|Placebo|The patients allocated to the Placebo group will be treated with detuned pulsed ultrasound therapy for 5 minutes and detuned short wave diathermy in pulsed mode for 25 minutes. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week).
16105321|NCT02123394|Other|McKenzie method|The patients of the McKenzie group will be treated according to the principles of the method and the choice of therapeutic intervention will be guided by the physical examination findings and classification. Patients will also receive written instructions from the Treat Your Own Back book and will be asked to perform home exercises based on the principles of McKenzie method. The description of the exercises that will be prescribed in this study are already published elsewhere. Compliance with home exercises will be monitored by means of a daily-log that the patient will fill in at home and bring to the therapist at each subsequent session. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week).
16105322|NCT02123381|Radiation|preoperative radiotherapy|"Patients receive intensity modulated radiation therapy(IMRT) or image-guided radiation therapy(IGRT)from week 1 to week 4,once a day, 5 times per week.
~Radiotherapy dose：95% gross tumor volume（GTV-T） 40Gy/20f，GTV-N 40Gy/20f，CTV-T 40Gy/20f，CTV-N 40Gy/20f."
16105323|NCT02123381|Drug|cetuximab|400mg/m2/week, 2 hours,iv,at week 1;250mg/m2/week,1hour,iv,at week 2-4
16105324|NCT02123368|Drug|Hyaluronic acid|Single intraarticular injection of Hyaluronic acid (Hyal One)
16105325|NCT02123368|Biological|10 million Bone marrow mesenchimal stem cells|10 million of Bone marrow mesenchimal stem cells
16105326|NCT02123368|Biological|100 million Bone marrow mesenchimal stem cells|100 million of Bone marrow mesenchimal stem cells
16105327|NCT02123355|Drug|Induction of anesthesia|Midazolam 0.05 mg/kg、Propofol 1.0 mg/kg、Sufentanyl 3μg/kg、Victracurium 0.1 mg/kg sequential intravenous injection
16105357|NCT02123108|Drug|Basiliximab|Peri-operative 40 mg IV dose and 20mg IV postoperative dose will be given in the treatment arm
16105329|NCT02123355|Drug|Sevoflurane, remifentanil ,vecuronium|Sevoflurane（1%-2%）is inspirated, and remifentanil 0.1-0.5μg/kg//min is continuously pumped,vecuronium 0.03 mg/kg is injected intermittently.
16105330|NCT02123355|Drug|Dexmedetomidine|Dexmedetomidine is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over.
16105331|NCT02123355|Drug|Placebo|Normal saline is given at 0.5μg/kg/h by continuous infusion and is stopped to given 30 minutes before the surgery is over.
16105332|NCT02123342|Behavioral|Exercise programme plus SMS reminders|Participants will receive SMS reminders for their myPAtHS exercise programme compared to the other group where participants will only receive the myPAtHS exercise programme.
16105333|NCT02123329|Behavioral|Pharmacist delivered smoking cessation program|"The first session will be time-intensive taking around 30 minutes. In this session, the study pharmacist will facilitate the participant's preparation to quit. The participant will select a quit date within the next 2-4 weeks. The pharmacist will discuss with the participant the benefits of smoking cessation and will provide him or her with tailored behavioral and lifestyle strategies.
~To prevent nicotine withdrawal symptoms, the participant will be offered nicotine replacement therapy (NRT) The first follow-up session will be scheduled after 1 week of the participant's quit day and will take around 20 minutes. In this session, the pharmacist will determine the participant's smoking status and assess the NRT tolerability.
~• If the participant fails to quit smoking, the pharmacist will carefully review the participant's experience during the attempt to quit and will work through the identified problems"
16105334|NCT02123329|Other|Control arm (i.e: regular care)|Participants in the control group will receive 5-10 minutes of unstructured brief smoking cessation advice by the pharmacist. In addition they will be provided with educational materials about smoking cessation and will be offered nicotine replacement therapy (NRT).
16105335|NCT02123316|Biological|Pangramin Plus D. pteronyssinus|Subcutaneous immunotherapy with Dermatophagoides pteronyssinus
16105336|NCT02123316|Biological|Placebo|Placebo for subcutaneous injection
16105337|NCT02123290|Drug|DSM265 400mg|
16105338|NCT02123290|Drug|DSM265 xmg|Dose of DSM265 to be determined based on the results of the first cohort
16105339|NCT02123290|Drug|DSM265 ymg|Dose of DSM265 to be determined based on the results of the second cohort
16105340|NCT02123277|Device|Balloon catheter for the Eustachian tube|Balloon catheter is inserted in the Eustachian tube to dilate it.
16105341|NCT02123264|Drug|Zoledronic acid|Zoledronic acid: 5 mg/year x 2 years
16105342|NCT02123251|Behavioral|Financial Incentives|This intervention will examine the effects of incentives on improving adult diabetic Medicaid beneficiaries' health outcomes and reducing associated costs through healthy behavior changes in their diabetes self-management. Incentives focus on improving self-management of diabetes, compliance with ADA recommended preventive, treatment and management measures, primary biometric measures of diabetes, and eliminating barriers to a healthy lifestyle
16105343|NCT02123238|Other|bed positioning|
16105344|NCT02123212|Other|Mailer|Henry Ford intentifies patients meeting birth cohort screening criteria and then sends mailers to those individuals. Mailers contained HCV guidelines, the importance of screening, laboratory slips and locations for patients to act directly on their own behalf. If patients do not respond to the initial mailer, Henry Ford sends additional mailers.
16105345|NCT02123212|Other|In-person recruitment|UAB used study coordinators to actively screen and recruit patients who met the inclusion criteria for birth-cohort screening. Study coordinators were located at two internal medicine clinics, where they approached eligible participants in person. A control group was pulled from an additional two internal medicine clinics, which screened using a risk-based strategy. A cross-over approach was used, so that the intervention and control clinics switched at the midpoint of data collection, allowing all four clinics to participate in both arms of the study.
16105346|NCT02123212|Other|EHR Alert|EHR include a Best Practice Alert (BPA) prompting the Medical Assistant and/or clinican to order a Hepatitis C lab test for patients in the birth cohort.
16105347|NCT02123199|Drug|Indacaterol (Onbrez®) /QAB149|
16105348|NCT02123186|Other|newborn screening test for SMA|Routine newborn screening dried blood spots sample is used to test if missing 2 copies of SMN1 gene.
16105349|NCT02123160|Behavioral|Child Parent Psychotherapy (CPP)|Child Parent Psychotherapy (CPP) is a multi-theoretical approach to enhance the caregiver-child relationship in the context of the caregiver's psychiatric history (e.g., depression) and/or caregiver/child exposure to traumatic events. Mother and child's in-session interactions are used to provide developmental guidance, and reinforce reciprocity between parent and child, affect regulation , continuity in daily living, and helping mother and child understand themselves and each other in the context of the maternal psychiatric functioning and/or familial exposure to trauma. When there is a history of trauma exposure for mother and/or child, mother and child create a joint narrative of the trauma, identify and address traumatic triggers, and focus on safety issues.
16105350|NCT02123160|Behavioral|Control (usual treatment)|Following Time 1 (pre-treatment) assessment, mother-child patient dyads randomized to the control group will be referred to usual treatment in the community for psychoeducation, counseling/ therapy for maternal depressive symptoms, and child behavioral/ emotional difficulties. Control patient dyads will be closely monitored through regular contact with the study research assistant and follow up by a licensed study clinician to assess mother/ child's psychiatric functioning and make necessary referrals to alternative treatments or arrange an emergency evaluation, if needed.
16105351|NCT02123134|Drug|ATX-101|Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
16105352|NCT02123134|Drug|Placebo|Phosphate buffered saline placebo for injection
16105353|NCT02123121|Drug|Resveratrol 1000 mg/day|Orally consume resveratrol 1000 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
16105354|NCT02123121|Drug|Resveratrol 1500 mg/day|Orally consume resveratrol 1500 mg/day capsule following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
16105355|NCT02123121|Other|Vegetable cellulose|Orally consume placebo vegetable cellulose capsule a day following each main meal (i.e. breakfast, lunch, and dinner), (i.e. take 3 capsules per day) for 90 Days.
16105356|NCT02123121|Other|All groups|All Participants will have the following done: Physical Exams, Physical Measurements, Medical History, Questionnaires, Blood Samples, Tests of physical performance, and muscle tissue samples.
16107396|NCT02108548|Drug|naproxen|oral
16105361|NCT02123069|Drug|Acetylcholine|Acetylcholine will be infused into the brachial catheter while blood flow levels in the forearm are measured. Acetylcholine will be infused at the following doses: 1.0, 2.0, 4.0, and 8.0 ug/100 ml tissue/min for 2 minutes each.
16105362|NCT02123069|Drug|Nitroprusside|Nitroprusside will be infused into the brachial catheter while blood flow levels in the forearm are measured. Nitroprusside will be infused at the following doses: 0.25, 0.5, 1.0, and 2.0 ug/100 ml tissue/min for 2 minutes each.
16105363|NCT02123069|Drug|Norepinephrine|Norepinephrine will be infused into the brachial catheter while blood flow levels in the forearm are measured. Norepinephrine will be infused at the following doses: 1.0, 2.0, 4.0, and 8.0 ug/100 ml tissue/min for 2 minutes each.
16105364|NCT02123069|Drug|Nitroprusside and phenylephrine|A single dose of nitroprusside (100 ug) will be infused through an IV; one minute later, a single dose of phenylephrine (150 ug) will be infused.
16105365|NCT02123056|Drug|Metoprolol|the daily dose range is 25mg twice a day to a maximum of 100mg twice a day
16105366|NCT02123056|Drug|Matching Placebo|the daily dose range is 25mg twice a day to a maximum of 100mg twice a day
16105367|NCT02123043|Behavioral|Motor learning-based training|The motor learning-based training will focus on some of the core concepts in the field of motor learning. The key concepts will include variable practice with respect to speed, feedback (both intrinsic and extrinsic but focusing on extrinsic), feedback focusing on three main variables (wheeling pattern, speed of hand when contacting push rim, push angle), sequential learning (specifically relating to wheeling pattern), and mental imagery (during the rest breaks).
16105368|NCT02123043|Behavioral|Practice wheeling|The practice wheeling will consist of the same amount of wheeling exposure compared to the motor learning-based training group, however no feedback regarding an individuals's wheeling will be provided. Participants randomized to this group will wheel for two 5-minute trials/ visit for 6 visits for a total of 60 minutes of wheeling exposure.
16105369|NCT02123017|Drug|90 grams of Crystalline Lactulose|15 mg of bisacodyl, plus 30 grams crystalline lactulose x 3 doses
16105370|NCT02123017|Drug|135 grams of Crystalline Lactulose|15 mg of bisacodyl, plus 45 grams crystalline lactulose x 3 doses
16105371|NCT02123017|Drug|180 grams of Crystalline Lactulose|15 mg of bisacodyl, plus 60 grams crystalline lactulose x 3 doses
16105372|NCT02123004|Drug|Ticagrelor|180mg loading dose for one day ,and then 90mg per day for 4 weeks
16105373|NCT02123004|Drug|Clopidogrel|300mg loading dose for one day ,and then 75mg per day for 4 weeks
16105374|NCT02122978|Behavioral|Mindfulness Based Cognitive Therapy|MBCT 8 week course delivered by trained facilitator
16105375|NCT02122978|Behavioral|MBSC - minimal contact|8 week course in Mindfulness Based Self Compassion delivered remotely by audio guided MP3
16105376|NCT02122978|Behavioral|Mindfulness Based Self Compassion Therapy|Mindfulness Based Self Compassion Therapy - 8 wee course delivered by trained facilitator
16105377|NCT02122965|Other|Pharmacist-led medication review|Medication review is a structured, critical examination of a patient's medications with the objective of reaching agreement with the patient about treatment, optimizing the medications' impact, and minimizing the number of medication-related problems and adverse drug events.
16105378|NCT02122952|Biological|AVXS-101|Self-complementary AAV9 carrying the SMN gene under the control of a hybrid CMV enhancer/chicken-β-actin promoter
16105379|NCT02122939|Drug|Escitalopram|
16105380|NCT02122926|Other|Intensive discharge intervention|"The intervention is a multi-modal program consisting of the following:
~Inpatient protocol for adjusting the discharge diabetes regimen;
~Nurse practitioner discharge advocate to schedule follow-up appointments, prepare an after-hospital care plan, and patient education and counseling;
~Inpatient pharmacist counseling (identifying and addressing previous barriers to medication adherence, performing enhanced medication reconciliation, and patient education);
~Visiting nurse intervention after discharge;
~Follow-up in a post-discharge clinic with the NP discharge advocate and pharmacist /certified diabetes educator within 3 days of discharge;
~Telemonitoring of POC glucose levels to the study CDE, patient's PCP, or endocrinologist as appropriate; and
~Follow-up with PCP or endocrinologist within 1 week of discharge."
16105381|NCT02122913|Drug|Larotrectinib (Vitrakvi, BAY2757556)|BAY2757556 will be administered orally as capsule or in liquid form over continuous 28-day cycles.
16105382|NCT02122887|Behavioral|Peace-Building Intervention Process|"The eight sessions include (1) presentation of the self to others members (2) getting familiar with the other culture (3) what is a conflict - how do conflicts come about, what are adaptive and non-adaptive modes of resolving conflict (4) getting to know the Other - preconceived notions about the other side (5) on dialogue- what is dialogue, can dialogue offer means for conflict resolution, what are the benefits of dialogue to inter-cultural and inter-racial conflicts, (6) empathy, generosity, and kindness (7) wrapping up - hopes for the future at the personal and community levels, practical suggestions (8) goodbye and summary - what have we learned ,gift giving, summary of process by group leaders."
16105383|NCT02122874|Device|Percutaneous Neurostimulation (PENS) of dermatome T7|The patients undergo PENS of dermatome T7 and follow a 1200 Kcal diet
16105384|NCT02122874|Other|1200 Kcal diet|
16105385|NCT02122861|Biological|ID-LV305|pembrolizumab
16105386|NCT02122848|Device|BiLevel|The intervention will be performed using BiLevel ventilation mode with EPAP=10 cmH2O and a IPAP which manages 6-8ml/kg tidal volume.
16105387|NCT02122835|Behavioral|aerobic exercise training|12 weeks of supervised aerobic exercise training
16105388|NCT02122822|Biological|gp96|vaccination of autologous gp96 derived from tumor tissue + basal treatment
16105389|NCT02122809|Drug|Chiauranib|Take orally
16105390|NCT02122796|Other|Acupuncture|Acupuncture involves inserting thin, sterile needles into the skin at certain points in the body.
16105391|NCT02122783|Device|ADR™ brace resistance|
16105392|NCT02122783|Device|Conventional brace resistance (using hard stops)|Conventional polypropylene custom molded ankle foot orthosis (MAFO) with Lawrence style double channel adjustable joints containing pins/springs
16105393|NCT02122770|Drug|MLN4924|MLN4924 intravenous solution.
16105394|NCT02122770|Drug|Fluconazole|Fluconazole tablets.
16105395|NCT02122770|Drug|Itraconazole|Itraconazole oral solution.
16105396|NCT02122770|Drug|Docetaxel|Docetaxel intravenous solution.
16105397|NCT02122770|Drug|Carboplatin|Carboplatin intravenous solution.
16105398|NCT02122770|Drug|Paclitaxel|Paclitaxel intravenous solution.
16105399|NCT02122757|Device|Cefaly tDCS|Cefaly tDCS (transcranial direct current stimulation) is able to modify cortical excitability, in particular anodal tDCS increases it. The side effects of tDCS are minor, especially sensations of itching and scalp paresthesias.
16105400|NCT02122757|Device|sham Cefaly tDCS|2mA during 30sec
16105401|NCT02122744|Device|Super Rapid Magstim Stimulator|"The repetitive transcranial magnetic stimulation (rTMS) is able to modify cortical excitability and reactivity. 1Hz rTMS inhibits the cortex, 10Hz excites it. In particular, a new paradigm of rTMS, the rTMS quadri pulse has a more lasting and effective activity.
~The side effects are rare and transient: migraine,contractions of the muscles of the neck due to muscle stimulation by the electromagnetic field of the coil."
16105402|NCT02122744|Device|Super Rapid Magstim Stimulator (sham)|coil perpendicular to the scalp
16105403|NCT02122731|Drug|Amiloride|5 mg(daily of amiloride was added to patients triple antihypertensive therapy and increased to 10 mg/daily if office blood pressure at 4 weeks was above 130/80 mmHg.
16105404|NCT02122718|Drug|Allopurinol|
16105405|NCT02122718|Drug|Placebo|
16105406|NCT02122705|Device|VPIA remifentanil|Vital signs controlled patient assisted intravenous analgesia using remifentanil
16105407|NCT02122692|Drug|Lu AE58054 30 mg|Lu AE58054 encapsulated film-coated tablets, once daily, Day 1-5, orally
16105408|NCT02122692|Drug|Lu AE58054 30 mg + itraconazole 200 mg|Lu AE58054 encapsulated film-coated tablets, once daily, Day 6-11, orally + itraconazole capsules, once daily, Day 6-11, orally
16105409|NCT02122692|Drug|Itraconazole|Itraconazole capsules, once daily, Day 12-13, orally
16105410|NCT02122679|Drug|Tranexamic Acid|
16105411|NCT02122679|Drug|placebo|
16105412|NCT02122666|Procedure|muscle biopsy|A member of the study team will obtain a small sample of muscle tissue from the patient's thigh (vastus lateralis muscle).
16105413|NCT02122653|Other|Weight training|Participants will perform 4 weeks of Weight training for lower extremities.
16105414|NCT02122653|Device|Electronic muscle stimulator|Participants will perform 4 weeks of electrical stimulation for Quadriceps muscle belly.
16105415|NCT02122627|Drug|Vitamin D|Colecalciferol 16.800 IU per week
16105416|NCT02122627|Drug|Placebo|
16105417|NCT02122614|Behavioral|Pulmonary rehabilitation (PR) plus PA monitoring and feedback from a pedometer|Patients will enrol in a 12-week PR program comprising exercise training (3 times per week) and psychoeducation sessions (once a week). Patients will also receive a pedometer to self-monitor their PA during and after the PR program and individualized step-count goals.
16105418|NCT02122614|Behavioral|Pulmonary rehabilitation (PR)|Patients will enrol in a 12-week PR program comprising exercise training (3 times per week) and psychoeducation sessions (once a week).
16105419|NCT02122601|Drug|LBSA0103 (BDDE cross-linked sodium hyaluronate gel)|
16105420|NCT02122562|Drug|Ketamine|Treatment
16105421|NCT02122562|Other|Alcohol Infusion|Biomarker
16105422|NCT02122549|Device|HWD1000|Wearable cardioverter-defibrillator designed for inpatient use
16105423|NCT02122536|Drug|Xeomin to right side of face in half of the subjects; Xeomin to left side of face in the other half of subjects|Subjects were randomized to which side of the face would be treated with Xeomin.
16105424|NCT02122536|Drug|Botox to right side of face in half of the subjects (randomized); Botox to the left side of the face in the other half of subjects|Subjects were randomized to which side of the upper face would be treated with Botox
16105425|NCT02122523|Procedure|Near-Infrared (NIR) dye Indocyanin Green (ICG)|
16105426|NCT02122510|Drug|Bupivacine group|Bupivacaine group(n=30) will receive post-delivery bilateral TAP block with 10 ml of bupivacaine 0.5 % mixed with 10 ml saline and 10 μg dexmetonedine in 20 ml syringe
16105427|NCT02122510|Drug|Dexmedetomidine|Dexamedtomedine group will receive post-delivery bilateral TAP block with 10 ml of bupivacaine 0.5 % mixed with 10 ml saline and 10 μg dexmetonedine in 20 ml syringe
16105428|NCT02122497|Procedure|abdominal aortic surgery|
16105429|NCT02122484|Drug|Colchicine|colchicine p.os 0.5 mg bid for two days before undergoing elective CABG surgery and eight days after the operation
16105430|NCT02122471|Drug|Plecanatide|
16105431|NCT02122471|Drug|Placebo|
16105432|NCT02122458|Device|mild-gain hearing aids|open-fit hearing aids with mild amplification in the high frequencies.
16105433|NCT02122445|Device|Cramer Sports Motion Tape|lower body exercises with and without Cramer Sports Motion tape applied to the hip
16105434|NCT02122432|Other|Teledermatology|"General practitioner takes 3 photographs per dermatologic lesion using either a telephone with a 3Mega Pixel minimum camera or a standard camera following recommendations of the practice guidelines for teledermatology (2007) of the American Telemedicine Association.
~Photographs are sent by email using a secured mail server with at least the following information=date of symptoms, symptomatology, topography of lesions, description of lesions, extension, recent drug intakes)
~Photographs are read and analyzed by a single dermatologist who gives an expert answer (diagnosis and/or treatment). Answer is sent back to the general practitioner by email (using a secured mail server). Answer contains at least the following information= are photographs usable? What is the diagnosis? If necessary, which treatment should the general practitioner begin ? If necessary, does the patient need a consultation with a dermatologist ?"
16105435|NCT02122419|Other|lateral|spinal anesthesia performed during lateral position
16105436|NCT02122419|Other|sitting|spinal anesthesia performed during sitting position
16105437|NCT02122406|Other|Hospital Anxiety and Depression Scale (HADS) questionnaire|Patients filled in the Hospital Anxiety and Depression Scale (HADS) questionnaire
16105438|NCT02122393|Drug|Sertraline|
16105439|NCT02122393|Behavioral|Cognitive Behavioural Therapy|
16105440|NCT02122380|Drug|Sitagliptin|Sitagliptin 100 mg by mouth daily for 30 Days
16105441|NCT02122380|Drug|Placebo|1 placebo pill by mouth per day for 30 days
16105442|NCT02122367|Other|HES 130/0.4 (VolulyteⓇ, Fresenius Kabi, Canada)|HES 130/0.4 (VolulyteⓇ, Fresenius Kabi, Canada) 6ml/kg of ideal body weight loading
16105443|NCT02122354|Behavioral|"Hide and Seek videogame"|
16105490|NCT02122055|Drug|Midazolam|Midazolam 2 mg is slowly titrated to Riker Sedation Agitation Score(SAS) 3-4 every 10 minutes, then Midazolam 0.02-0.1 mg/kg/h is maintained.
16105603|NCT02121262|Drug|Dexamethasone|Dexamethasone 700 μg intravitreal injection in the study eye on Day 1, Months 5, and 10.
16105444|NCT02122341|Device|BackStop|BackStop™ is a FDA approved device. It is intended for use during ureteroscopic lithotripsy to prevent retrograde migration of stones and stone fragments. It is comprised of a solution of a thermosensitive polymer, a purified version of poloxamer 407 having been fractionated in saline. BackStop™, which is injected above the stone, is provided in sterile, pre-filled 2.5ml and 5ml syringes along with and a corresponding injector and a catheter (3F or 5F).
16105445|NCT02122328|Procedure|Sequential laser photocoagulation of communicating vessels.|
16105446|NCT02122328|Procedure|Selective laser photocoagulation of communicating vessels|
16105447|NCT02122315|Other|Physical therapy plus dry needling|Best-evidence physical therapy intervention in addition to a single session of TrP-DN targeted to active TrPs in the neck-shoulder muscles
16105448|NCT02122315|Other|Physical therapy|Best-evidence physical therapy intervention
16105449|NCT02122302|Device|CarePrep Online Health Assessment|Patients can utilize a web-based self-assessment system to answer questions that address medical, psychological, social, behavioral, and quality-of-life issues that are relevant to pancreatic disease. Patients can enter and track their symptoms over the Internet from home or clinic. The system is also designed to gather clues to identify neuropathic pain, which occurs when the nervous system fails to properly regulate pain signals.
16105450|NCT02122289|Device|Application of Smartphone|Weekly questionnaire on smartphone
16105451|NCT02122289|Other|No application Smartphone|No weekly questionnaire on smartphone
16105452|NCT02122276|Procedure|Ankle continuous passive motion machine.|A rehabilitation program of machine driven passive stretch exercise on ankle.
16105453|NCT02122250|Behavioral|Interactive web-based materials|Interactive web-based materials for self-management of diabetes
16105454|NCT02122250|Behavioral|Static web-based materials|Static web-based materials
16105455|NCT02122237|Device|Cefaly tDCS|Cefaly tDCS (transcranial direct current stimulation) is able to modify cortical excitability, in particular cathodal tDCS decreases it. The side effects of tDCS are minor, especially sensations of itching and scalp paresthesias.
16105456|NCT02122224|Other|High fiber breakfast|Breakfast will contain 10-11g fiber.
16105457|NCT02122224|Other|High Protein Breakfast|Breakfast will contain 19-20g of protein.
16105458|NCT02122224|Other|High Protein/High Fiber Breakfast|Breakfast will include 19-22g of protein and 10-12g of fiber.
16105459|NCT02122211|Drug|Betaine supplement|
16105460|NCT02122198|Drug|Leuprolide acetate|Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 9 months. First 6 months under parent study (FAME) protocol (NCT01712230); months 6-9 under sub-study.
16105461|NCT02122198|Drug|Estradiol|Climara transdermal patch 0.075mg/day applied weekly months 6-9
16105462|NCT02122198|Drug|Medroxyprogesterone|Provera 5mg tablets once daily by mouth for 12 days beginning at week 30.
16105463|NCT02122198|Drug|Placebo|placebo
16105464|NCT02122185|Drug|metformin hydrochloride|Given PO
16105465|NCT02122185|Drug|placebo|Given PO
16105466|NCT02122185|Drug|Chemotherapy|Participants will received standard chemotherapy (6-8 cycles). Specific regimen to be given is at the discretion of their treating physician.
16105467|NCT02122172|Drug|afatinib dimaleate|Given PO
16105468|NCT02122172|Other|laboratory biomarker analysis|Correlative studies
16105469|NCT02122159|Biological|MA09-hRPE Cellular Therapy|A suspension of either 50,000 MA09-hRPE cells (first cohort), 100,000 MA09-hRPE cells (second cohort), 150,000 MA09-hRPE cells (third cohort) or 200,000 MA09-hRPE cells (fourth cohort) in 150 uL of BSS plus will be implanted over 1 minute in the space created.
16105470|NCT02122146|Drug|PF-06664178|Part 1 - PF-06664178 will be administered intravenously every 21 days in cohorts of 2 or more patients starting at a dose of 0.15 mg/kg. Increases in dose will continue until MTD is determined.
16105471|NCT02122146|Drug|PF-06664178|Part 2 - patients with select tumor types (Non Small Cell Lung Cancer ovarian cancer, and breast cancer ) will be treated at the MTD selected in Part 1.
16105472|NCT02122133|Device|PC 400|
16105473|NCT02122120|Dietary Supplement|HEN|Patients with tube feeding with FSMP for at least twelve months
16105474|NCT02122094|Behavioral|Sexual Health Promotion Intervention|The seven core modules are 1) the Importance of Sexual Health, 2) Sexual Diversity, 3) HIV and other STIs, 4) Behavioral Risk and Risk Reduction, 5) Alcohol and Drugs, 6) Stigma and 7) Health Seeking Practices. The five optional modules are 1) HIV Treatment and Adherence, 2) Stress Reduction, 3) HIV Status Disclosure, 4) MSM/Gay Disclosure, and 5) Other Sexual Health Concerns
16105475|NCT02122081|Radiation|radiation therapy|Undergo organ-sparing marrow irradiation BID on days -6 to -4
16105476|NCT02122081|Drug|cyclophosphamide|Given IV over 1-2 hours every 24 hours on days -3 to -2.
16105477|NCT02122081|Biological|anti-thymocyte globulin|
16105478|NCT02122081|Drug|tacrolimus|Given IV or PO
16105479|NCT02122081|Drug|methotrexate|Given IV
16105480|NCT02122081|Procedure|allogeneic bone marrow transplantation|Undergo allogeneic peripheral blood progenitor cell or bone marrow transplant on day 0
16105481|NCT02122081|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo allogeneic peripheral blood progenitor cell or bone marrow transplant
16105482|NCT02122081|Procedure|peripheral blood stem cell transplantation|Undergo allogeneic peripheral blood progenitor cell or bone marrow transplant
16105483|NCT02122081|Other|laboratory biomarker analysis|Correlative studies
16105484|NCT02122068|Behavioral|Mentalizing Imagery Therapy|4 week long meditation and mindfulness intervention
16105485|NCT02122068|Behavioral|Relaxation cd|
16105486|NCT02122055|Drug|Fentanyl|Fentanyl 0.7-1μg/kg，prn pain assessment is done every 4 hours，maintain Behavioral Pain Scale（BPS） 0-2.
16105487|NCT02122055|Procedure|Sedation assessment|Sedation assessment is done every 4 hours,maintain the Riker Sedation Agitation Score(SAS) 3-4.
16105488|NCT02122055|Procedure|Screen of weaning|1. Screen of weaning is done at 8:00 every morning. 2 If the patient is successful to wean, stop the Dexmedetomidine sedation. 3. If failed to wean, the patient is ventilated again and try to wean after 24 hours, until it is successful to wean and stop sedation，
16105489|NCT02122055|Drug|Propofol|Propofol is started with dosage of 0.3 mg/kg/h, observe the patient's response, increase 0.3 mg/kg/h propofol every 10 minutes until target sedation level is obtained(Riker Sedation Agitation Score(SAS) 3-4),then 0.3-3 mg/kg/h propofol is maintained.
16105491|NCT02122055|Drug|Dexmedetomidine|After the screen of the weaning is passed, change to Dexmedetomidine sedation, the dose is 0.2-0.7 mg/kg/h and continuously pumped, increase the dose 0.1-0.2 mg/kg/h every 30 minutes, titrate to Riker Sedation Agitation Score(SAS) 3-4，the maximum dose is 1 mg/kg/h maintained，and prepare for weaning.
16105492|NCT02122042|Biological|HBOT|
16105493|NCT02122029|Behavioral|Lifestyle counselling|Behavioral techniques for weight management
16105494|NCT02122029|Procedure|Bariatric Surgery|Vertical Banding Gastroplasty
16105495|NCT02122016|Device|SmartCare|Ventilator with a SmartCare module that is capable of performing a computer-driven weaning trial taking into account patients lung mechanics and exaled CO2.
16105496|NCT02122016|Other|Conventional weaning protocol|A conventional weaning protocol performed by physiotherapist with a daily weaning screen and a spontaneous breathing trial
16105497|NCT02122003|Drug|Sorafenib|Sorafenib 400 mg bid
16105498|NCT02121990|Drug|Paclitaxel,|
16105499|NCT02121990|Drug|Bevacizumab|
16105500|NCT02121990|Drug|Cisplatin|
16105501|NCT02121990|Drug|Olaparib|
16105502|NCT02121977|Device|Elevate Anterior and Apical|
16105503|NCT02121977|Procedure|Native Tissue Repair for pelvic organ prolapse|
16105504|NCT02121964|Procedure|Capsulectomy in Direct Anterior Total Hip Arthroplasty|Surgical intervention in which the surgeon will perform anterior capsulectomy during total hip arthroplasty.
16105505|NCT02121964|Procedure|Capsulotomy in Direct Anterior Total Hip Arthroplasty|Surgical intervention in which the surgeon will perform anterior capsulotomy during total hip arthroplasty. Surgeon will repair the joint capsule.
16105506|NCT02121951|Procedure|Local Anesthetic infiltration|Lignocaine infiltration through the nephrostomy track
16105507|NCT02121951|Procedure|Quadratus Lumborum block|A linear 12-MHz ultrasound probe will be placed in the anterior axillary line to visualize the typical triple abdominal layers. Then, the probe will be placed in the midaxillary line and at this point the layers of abdominal layers starte to taper. The probe will be placed in the posterior axillary line, sonoanatomy will show first the transversus abdominis disappearing then the internal oblique and external oblique forming aponeurosis and appearance of QL will be noticed. At the posterior border of the quadratus lumborum muscle and outside the fascia, Touhe needle will be inserted in plane and confirmed its position by injecting saline. Under ultrasound (US) guidance, local anesthetic mixure will be deposited separating the fascia
16105508|NCT02121951|Drug|MAC|Incremental doses are given to the targed sedation and analgesia
16105509|NCT02121912|Device|FPH Pilairo Q CPAP mask|CPAP nasal-pillow mask
16105510|NCT02121912|Device|Any other market released nasal or nasal-pillow CPAP mask|Any other market released nasal or nasal-pillow CPAP mask
16105511|NCT02121886|Procedure|venous reconstruction with the parietal peritoneum|
16105512|NCT02121873|Device|Nipple aspirator|The subject will undergo nipple aspiration with a suction device designed to elicit fluid from the nipple.
16105513|NCT02121873|Device|Ductal lavage microcatheter|Upon completion of the nipple aspiration procedure, subjects will undergo a nipple block with local anesthesia. The duct will be lavaged with the ductal lavage microcatheter. Samples will be immediately processed for shipping to Covance for WGS. Subjects will be contacted 24 hours and again 2 weeks after the procedure to collect any untoward effects of participating in the study.
16105514|NCT02121873|Device|Blood draw|Blood will be drawn and immediately processed for shipping to Covance for WGS.
16105515|NCT02121860|Drug|IDN-6556|
16105516|NCT02121847|Drug|cyclosporine 0.05% ophthalmic emulsion|Cyclosporine 0.05% ophthalmic emulsion (Restasis®) eye drops administered twice daily for 6 months.
16105517|NCT02121847|Drug|carboxymethylcellulose-based lubricant eye drops|Carboxymethylcellulose-based lubricant eye drops (Refresh OPTIVE® Advanced) administered as needed for 6 months.
16105518|NCT02121834|Drug|LY3050258|
16105519|NCT02121834|Drug|Placebo|
16105520|NCT02121821|Behavioral|SMS reminder messages|The study is prospective and interventional comparing differences between pregnant women who receive reminder messages via the SMS Mother Reminder system to those who are not. Pregnant women will be followed from their first ANC visit at a health facility through delivery. The study will examine the effect of the mobile phone intervention on attendance to ANC appointments and IPTP2 coverage. The intervention group will be composed of pregnant women receiving SMS reminder messages in comparison with a control group of pregnant women receiving no intervention (i.e. no SMS reminders).
16105521|NCT02121808|Procedure|NIPPV|"Ventilation: non-invasive positive pressure ventilation (NIPPV)
~Positive end-expiratory pressure: 10 cmH20 Pressure support: 5 - 20 cm H2O for tidal volume of 10 mL / kg (ideal body weight)"
16105522|NCT02121808|Procedure|Tidal volume|Tidal volume spontaneous ventilation, no assistance.
16105523|NCT02121795|Drug|FTC/TDF|200/300 mg FDC tablets administered orally once daily
16105524|NCT02121795|Drug|F/TAF|Tablets administered orally once daily
16105525|NCT02121795|Drug|Allowed third antiretroviral agent|An allowed third antiretroviral agent of the participant's pre-existing regimen may include one of the following: ritonavir-boosted atazanavir (ATV/r), ritonavir-boosted lopinavir (LPV/r), ritonavir-boosted darunavir (DRV/r), efavirenz (EFV; Sustiva®), rilpivirine (RPV; Edurant®), nevirapine (NVP;Viramune®), raltegravir (RAL; Isentress®), dolutegravir (DTG;Tivicay®), and maraviroc (MVC; Selzentry®).
16105526|NCT02121795|Drug|FTC/TDF Placebo|Tablets administered orally once daily
16105527|NCT02121795|Drug|F/TAF Placebo|Tablets administered orally once daily
16105528|NCT02121782|Biological|Quadrivalent influenza vaccine|GC3110A, 0.5ml, intramuscular, a single dosing at Day 1
16105529|NCT02121782|Biological|Trivalent influenza vaccine|GC Flu Pre-filled Syringe Inj., 0.5ml, intramuscular, a single dosing at Day 1
16105530|NCT02121769|Drug|Omegaven|10% Omegaven 1g/kg/day, Intravenous by continuous infusion in conjunction with parenteral nutrition, until the patient no longer requires parenteral nutrition or until participation in the study is terminated.
16105531|NCT02121756|Drug|Dipyridamole|Dipyridamole 100 mg four (4) times daily for 24 weeks from Baseline to Week 24
16105532|NCT02121756|Drug|Placebo, then Dipyridamole|Placebo for Dipyridamole four (4) times daily for 12 weeks from Baseline to Week 12 followed by Dipyridamole 100mg four (4) times daily for 12 weeks from Week 12 to Week 24
16105533|NCT02121743|Device|strattice|use of a strattice
16105534|NCT02121743|Procedure|No strattice|no use of a strattice
16105538|NCT02121691|Behavioral|Walk by Faith|The Walk by Faith program is aimed at increasing physical activity and improving healthy eating to reduce or maintain healthy BMI among members of the churches.
16105539|NCT02121678|Other|Resistance training|"Participants do resistance training of selected muscle groups. Resistance are predefined from 1-repetition max (1-RM) and increased during the 12 weeks of training:
~Week 0-4: 70-80 % of 1-RM
~Week 5-8: 75-86 % of 1-RM
~Week 9-12: 80-92% of 1-RM
~Participants trains unilateral, the opposite site serves as reference.
~MMN patients train elbow (flexion/extension) and wrist (flexion/extension)
~CIDP patients train knee (flexion/extension) and elbow (flexion/extension)"
16105540|NCT02121678|Other|Aerobic training|"Participants train on ergometer bicycle 2 times weekly increasing during the first weeks to 3 times weekly. Workload is measured before initiation and VO2-max, heart rate and blood pressure will be measured as well.
~Patients train with 60-75 % of VO2-max for 30 minutes per training session. They use heart rate monitor to store data."
16105541|NCT02121665|Drug|Probiotic (Inersan)|Each Inersan lozenge contains not less than 1 billion CFU of Lactobacillus brevis CD2
16105542|NCT02121665|Drug|Placebo|Each placebo lozenge contains all excipients except the active constituent (Lactobacillus brevis CD2)
16105543|NCT02121652|Behavioral|Cognitive behavioral therapy for insomnia|Cognitive behavioral therapy for insomnia includes content on sleep restriction, stimulus control, relaxation, cognitive restructuring and sleep hygiene content delivered in a 90 minute group intervention with two follow up phone calls.
16105544|NCT02121652|Behavioral|Healthy eating control|Healthy eating control involves healthy eating content delivered in a 90 minute group session with two follow up phone calls.
16105545|NCT02121639|Drug|Placebo|
16105546|NCT02121639|Drug|AZD5363|
16105547|NCT02121613|Drug|Permixon® 160 mg|Oral administration - 160 mg twice daily.
16105548|NCT02121613|Drug|Tamsulosine LP|Oral administration - 0.4 mg daily.
16105549|NCT02121613|Drug|Placebo matching Permixon® 160 mg|Oral administration - twice daily.
16105550|NCT02121613|Drug|Placebo matching Tamsulosine LP|Oral administration - daily.
16105551|NCT02121600|Other|[F-18]-FCH|Before the PET/MRI or PET/CT scan, patients will receive an [F-18]-Fluorocholine injection in the arm.
16105552|NCT02121600|Radiation|PET scan|A whole body PET scan will be performed, combined with either whole body MRI or CT scan. This will be performed at baseline and after 12 weeks of treatment
16105553|NCT02121600|Radiation|MRI scan|Whole body MRI scan will be performed. This may be combined with PET scan or may be performed separately. MRI scan will be done at baseline and after 12 weeks of treatment
16105554|NCT02121587|Behavioral|Pain self-management course|This is an observational study of patient-reported outcomes from an experiential pain self-management course which integrates mindfulness and acceptance-based exercises into osteopathic manual therapy treatment. The intervention consists of six, individual, one-hour osteopathic evaluation and treatment sessions which incorporate pain education, the development of mindfulness skills to enhance body awareness, and the identification of personal values to promote compassionate self-care and sustain commitment to active coping strategies. The intervention aims to enhance patients' well-being and resilience through developing psychological and behavioural flexibility in response to persistent pain.
16105555|NCT02121574|Device|Zero flux and ingestible thermometers|
16105556|NCT02121561|Behavioral|Self-Acceptance Group Therapy|SAGT is an 8-week group therapy for persons with high levels of shame focused on providing psychoeducation regarding shame and self-acceptance and teaching skills for effectively responding to shame. SAGT is based on a cognitive-behavioral framework. Group members are taught how to recognize and challenge shame-eliciting thoughts, effectively discuss shame-eliciting topics with others, and build self-acceptance. Group members also complete weekly homework assignments that allow them to practice their new skills. All sessions include a review of homework and previously discussed concepts, introduction of new material, and in-session discussions/activities. The content of SAGT includes: defining self-acceptance and recognizing shame; increasing balanced thinking about oneself; improving social connections; increasing skillful interpersonal disclosure; challenging unhelpful expectations; handling setbacks; review and commitment to future practice.
16105557|NCT02121548|Behavioral|CHW Outreach and HPV Self-sampling|The intervention strategies will involve three overlapping domains 1)provide health education on cervical cancer screening, 2) motivation to encourage women to have screening 3) provide navigation services to obtain the screening. We envision visits lasting no more than 60 minutes. Women who are randomized to this arm will also include information on the alternative screening method. They will be told that cervical self-sampling is an alternative screening technique for the Pap smear and they will be offered the choice of having the HPV screen done during that home visit or have a Pap Smear at the participating FQHC.
16105558|NCT02121548|Behavioral|CHW Outreach|The intervention strategies will involve three overlapping domains 1)provide health education on cervical cancer screening, 2) motivation to encourage women to have screening 3) provide navigation services to obtain the screening. We envision visits lasting no more than 60 minutes.
16105559|NCT02121535|Drug|T80/A5 mg FDC tablet|
16105560|NCT02121535|Drug|T80/A5 mg FDC tablet|A Telmisartan 80 mg/ Amlodipine 5 mg FDC tablet
16105561|NCT02121535|Drug|H12.5 mg tablet|
16105562|NCT02121535|Drug|T80/A5/H12.5 ng FDC tablet|A Telmisartan 80 mg/Amlodipine 5 mg/HCTZ 12.5 mg FDC tablet
16105563|NCT02121535|Drug|H12.5 mf tablet|A HCTZ 12.5 mg tablet
16105564|NCT02121535|Drug|T80/A5/H12.5 mg FDC tablet|
16105565|NCT02121522|Drug|BI 144807|twice daily
16105566|NCT02121509|Drug|Linagliptin|1 x Linagliptin tablet
16105567|NCT02121509|Drug|Linagliptin/Metformin ER FDC|2 x Linagliptin/Metformin ER FDC tablet
16105568|NCT02121509|Drug|Metformin ER|3 x Metformin ER tablets
16105569|NCT02121496|Behavioral|Resources for Postpartum Parenting|The intervention includes four-sessions that targets maternal caregiving of young infants to increase infant sleep and reduce fuss/cry behavior and thereby simultaneously consolidate women's enjoyment of and confidence in their maternal role, this, in turn, promotes a cycle of a mutually re- warding engagement in the mother-infant dyad - the antithesis of a 'toxic' experience, and a strong foundation for improving the chances of a successful psychosocial adjustment, including adequate employment. Investigators believe PREPP holds tremendous promise as an intervention to fill the science-practice gap in the promotion of an optimal emotional environment for the developing infant, particularly for women and children living in poverty and/or facing significant psychosocial hardship.
16105573|NCT02121457|Dietary Supplement|Brazil nut|Participants of the treatment group were instructed to take one Brazil nut daily during 6 months. Brazil nuts were supplied in 2-month allowances at no cost together with written nutritional information and a calendar to monitor the compliance. Compliance was monitored in intervals of 2 months by checking the calendar and counting returned nuts. Compliance was considered to be adequate if ≥85% of Brazil nuts were consumed. All subjects were instructed to maintain their normal diet and to avoid additional Brazil nuts during the study.
16105574|NCT02121457|Dietary Supplement|selenium|
16105575|NCT02121444|Drug|Interferon beta-1b (Betaferon, BAY 86-5046)|
16105576|NCT02121444|Device|BETACONNECT auto-injector.|
16105577|NCT02121431|Behavioral|Triple P--Positive Parenting Program|The Triple P--Positive Parenting Program (Triple P), which has an extensive evidence base, is grounded in a common set of core principles of positive parenting and draws on a broad menu of parenting strategies. A key provision of Triple P is that parents are the decision-makers about program goals and selection/implementation of specific parenting strategies consistent with their preferences and values.
16105578|NCT02121418|Drug|Cytarabine|Given IV
16105579|NCT02121418|Drug|Decitabine|Given IV
16105580|NCT02121418|Other|Laboratory Biomarker Analysis|Correlative studies
16105581|NCT02121405|Procedure|Rectectomy|Include anterior resection or abdominoperineal resection by open or laparoscopy with Total Mesorectal Excision (TME).
16105582|NCT02121405|Radiation|Radiotherapy|45-50 Gy in 25-28 fractions to the pelvis. After 45 Gy a tumor bed boost with a 2 cm margin of 5.4 Gy in 3 fractions for preoperative cancers or 5.4-9.0 Gy in 3-5 fractions for postoperative cancers could be considered. Radiotherapy is used only for patients with pathological confirmed positive circumferential margin in Group primary surgery. Radiotherapy is used to all of the patients in Group preoperative radiochemotherapy.
16105583|NCT02121405|Drug|Capecitabine|Capecitabine 825 mg/m2 twice daily 5 or 7 days/week with concurrent radiotherapy in Group primary surgery and Group preoperative radiochemotherapy. Capecitabine 1250 mg/m2 twice daily 1-14 every 3 weeks to a total of 6 weeks after preoperative radiochemotherapy in Group preoperative radiochemotherapy. Capecitabine 1250 mg/m2 twice daily 1-14 every 3 weeks to a total of 6 months postoperative therapy for a part of stage II patients in Group of primary surgery. Capecitabine 1000 mg/m2 twice daily 1-14 every 3 weeks with oxaliplatin day 1 to a total of 6 months postoperative therapy for stage III patients in Group of primary surgery.
16105584|NCT02121405|Drug|Oxaliplatin|Oxaliplatin 130 mg/m2 over 2 hours, day 1, with capecitabine every 3 weeks. Repeat every 3 weeks to total of 6 months postoperative therapy.
16105585|NCT02121392|Device|Adductor Canal Nerve Block Catheter|ACNB catheter will be placed by anesthesia residents under the supervision of board-certified anesthesiologists familiar with regional anesthesia techniques, who are part of the anesthesia pain service. They will be performed at the bedside, aseptically, with the patient's vital signs monitored throughout the procedure. 1% lidocaine will be infiltrated in the skin and subcutaneous tissues overlying the adductor canal as visualized on ultrasound. Via a 17 gauge touhy needle a closed tip non-stimulating, epidural catheter will be placed after 1% lidocaine is used to hydrodissect the space lateral to the superficial femoral artery within the adductor canal. The catheter will be secured to the skin. All catheters will be connected to infusion pumps with opaque plastic bags covering the pumps. The functional ACNB pumps will run 8cc/h.
16105586|NCT02121392|Device|Adductor Canal Nerve Block Sham Catheter|Patients randomized to the sham catheter will have a chlorhexidine prep of the skin and ultrasound examination of the adductor canal on postoperative day #1. To minimize patient risk, a wooden applicator will be used to apply 10 seconds of pressure to the leg followed by catheter securing to the skin with the same tegaderm and paper tape dressing used on functional catheters. All catheters will be connected to infusion pumps with opaque plastic bags covering the pumps. The sham catheter pumps will not be turned on.
16105587|NCT02121392|Drug|Bupivacaine|In the functioning continuous adductor canal block, 0.125% bupivacaine will be infused at a rate of 8cc/hr.
16105588|NCT02121379|Behavioral|pulmonary rehabilitation|
16105589|NCT02121366|Procedure|EUS-guided ethanol ablation|Diagnostic evaluation for suspected insulinoma is performed by cytology or immunohistochemistry. EUS-FNA is performed to obtain samples. After puncturing with the needle, ethanol under the guidance of EUS was injected into the lesion. The amount of ethanol is administrated according to the size of lesion.
16105590|NCT02121353|Drug|Lucentis|Single-use 2 mL vial designed to deliver 0.05 mL of 10 mg/mL ranibizumab solution. Excipients: Alpha, alpha-trehalose dihydrate; histidine hydrochloride, monohydrate; histidine; polysorbate 20; water for injections Route of Administration: Intra-vitreal
16105591|NCT02121353|Drug|PF582|Single-use 2 mL vial designed to deliver 0.05 mL of 10 mg/mL ranibizumab solution. Excipients: Alpha, alpha-trehalose dihydrate; histidine hydrochloride, monohydrate; histidine; polysorbate 20; water for injections Route of Administration: Intra-vitreal
16105592|NCT02121340|Behavioral|Behavioral Activation|
16105593|NCT02121327|Other|disease management|disease management program include self management education
16105594|NCT02121327|Other|usual care|usual care group receive regular outpatient treatment
16105595|NCT02121314|Drug|intravenous administration of 1st line TB drugs, day 1|TB drugs IV on day 1 for calculation of bioavailability while fasting or fed
16105596|NCT02121301|Drug|Low Dose 0.155µg/mL SkQ1 ophthalmic solution|eyedrops
16105597|NCT02121301|Drug|High Dose 1.55µg/mL SkQ1 ophthalmic solution|eyedrops
16105598|NCT02121301|Drug|Placebo (Vehicle) opthalmic solution|eyedrops
16105599|NCT02121288|Drug|Ticagrelor|Day 1: Loading dose of ticagrelor 180mg (two 90mg tablets) followed by 90mg dose at 12 hours after loading dose. Subject continues to take ticagrelor 90mg twice a day (morning and evening) for 7 days until next visit (Day 7).
16105600|NCT02121288|Drug|clopidogrel|Day 1: Clopidogrel 75mg oral tablet. Subjects will continue to take clopidogrel 75mg once a day for 7 days until next visit (Day 7/Visit 3). Note: no loading dose is given for the clopidogrel as those subjects are already on chronic dosing.
16105601|NCT02121275|Device|Ultrasound of the lungs|Ultrasound examination of the lungs
16105602|NCT02121275|Device|Electric impedance tomography|Electric impedance tomography (EIT) is a noninvasive tool based on the measurement of electrical impedance changes within the thorax and lung tissue during ventilation and depicts the regional changes in ventilation in real time. To use electric impedance tomography 16 electrodes are applied in a circular fashion around the patient's chest, typically at the level of the 7th intercostal space.
16105604|NCT02121262|Procedure|Laser Photocoagulation|Laser photocoagulation on Day 1, and on Months 3, 6, and 9, if retreatment indicated.
16105605|NCT02121249|Device|Renaissance, Mazor Robotics Ltd, Caesare, Israel|Renaissance (Mazor Robotics Ltd, Caesare, Israel) is the name of the robot
16105606|NCT02121249|Procedure|free hand technique|"No specific device is necessary in the free hand technique"
16105607|NCT02121223|Device|post-dilatation with a Quantum Maverick balloon|post-dilatation with a Quantum Maverick balloon at high pressure (>=16atm) for at least 15 seconds.
16105608|NCT02121223|Device|manual thrombus aspiration + Promus Element stent implant|manual thrombus aspiration followed by Promus Element stent implantation at normal pressure
16105609|NCT02121210|Drug|sarilumab SAR153191 (REGN88)|Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous
16105610|NCT02121197|Drug|Ozurdex|
16105611|NCT02121184|Drug|Routine oxytocin|per regular oxytocin protocols
16105612|NCT02121184|Drug|Half-dose oxytocin|The dose of oxytocin currently being administered will be halved and not increased until after 60 minutes initiation of labor analgesia
16105613|NCT02121171|Device|Ologen Collagen Matrix|Use of ologen Collagen Matrix in trabeculectomy (ologen) Place ologen CM on the top of the loosely-sutured scleral flap under conjunctiva before suturing. It is recommended to suture the scleral flap with 1 or 2 stiches loosely and to coordinate with the tamponading effect of ologen CM to create a fluctuating scleral flap that prevents bleb wound adhesion and modulates aqueous humor outflow for ideal IOP control without leakage.
16105614|NCT02121171|Procedure|Combined trabeculotomy-trabeculectomy|Combined trabeculotomy and trabeculectomy is a standard surgery for congenital glaucoma, however, it has its known complications.
16105615|NCT02121158|Device|Implantable Cardioverter Defibrillator|The ICD and lead(s) will be FDA-approved.
16105616|NCT02121158|Other|Optimal Medical Therapy|Guidance on lifestyle modification, exercise training, and disease management including review of American Heart Association (AHA) Guidelines for Primary Prevention of Cardiovascular Disease and Stroke.
16105617|NCT02121145|Biological|Vivotif|3 oral doses
16105618|NCT02121145|Biological|Typherix|one intramuscular dose
16105619|NCT02121119|Drug|Lidocaine|Continuous block with lidocaine in both legs. Lidocaine infusion starts 0.5% to 5 ml hour Baxter Infusor elastomeric pump LV 5 ml / hr
16105620|NCT02121119|Drug|Bupivacaine|Continuous block with lidocaine in both legs. Infusion starts bupivacaine 0.1% to 5 ml hour Baxter Infusor elastomeric pump LV 5 ml / hr
16105621|NCT02121106|Behavioral|Cognitive Remediation|
16105622|NCT02121106|Behavioral|Sham Cognitive Remediation|
16105623|NCT02121093|Procedure|vibration|
16105624|NCT02121080|Drug|REGN2222(SAR438584)|
16105625|NCT02121080|Drug|placebo|
16105626|NCT02121067|Drug|Levonorgestrel Intrauterine System (LNG-IUS)|The LNG-IUS will be inserted at two-weeks postpartum (day 14-20 postpartum) in all 50 women enrolled
16105627|NCT02121041|Drug|Amlodipine|Amlodipine 5 mg or 10 mg
16105628|NCT02121041|Drug|Chlorthalidone|Chlorthalidone 12.5 mg or 25 mg
16105629|NCT02121041|Drug|Losartan|Losartan 50 mg or 100 mg
16105630|NCT02121015|Behavioral|Share|
16105631|NCT02121015|Behavioral|Self-Directed|
16105632|NCT02121002|Drug|Diclofenac Sodium Topical Gel, 1%|Opaque, white gel
16105633|NCT02121002|Drug|Voltaren Topical Gel, 1%|Opaque, white gel
16105634|NCT02121002|Drug|Vehicle Diclofenac Sodium Topical Gel|Opaque, white gel
16105635|NCT02120989|Behavioral|Partner-Assisted Cognitive Behavioral Therapy for Insomnia|Study treatment includes partner-assisted Cognitive Behavioral Therapy for Insomnia (CBT-I) and consists of 7-8 weekly group therapy sessions of 2 hours each. Partner-assisted CBT-I focuses on altering patients' sleep schedules and changing their behaviors and patterns around sleeping in order to help them sleep in a single block of time overnight. As part of this treatment, participants will be asked to change, possibly reduce, the amount of time spent in bed and to maintain a specific bed time and wake time, as well as other potential changes depending on his/her specific insomnia pattern. This treatment has been shown to be safe and efficacious for a wide range of patients.
16105636|NCT02120976|Drug|JTT-252 or Placebo|Subjects will receive JTT-252 or Placebo
16105637|NCT02120976|Drug|JTT-252|Subjects will receive JTT-252
16105638|NCT02120963|Behavioral|Person-centered physical therapy intervention program|Comparison of person-centered physical therapy and control group
16105639|NCT02120950|Drug|Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)|Eylea is administered as an intravitreal injection
16105640|NCT02120950|Other|Visudyne|Photodynamic therapy is a combined therapy of drug (Visudyne) applied to reinforce the action of a device (laser)
16105641|NCT02120937|Behavioral|MBCT-C Therapy|Mindfulness Based Cognitive Therapy for Children is a manualized psychotherapeutic intervention that combines mindfulness techniques with certain features of cognitive behavioral therapy. This particular protocol for youth includes weekly group sessions, regular home practice, and the core curriculum of formal mindfulness practices (e.g., body scan, sitting, movement, and walking meditations).
16105642|NCT02120924|Drug|Azelaic acid|Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
16105643|NCT02120924|Drug|Vehicle|Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
16105644|NCT02120924|Drug|Finacea|Dosage form: Topical gel Dosage: Apply gel to the affected areas of the face twice daily for 12 weeks. The amount needed depends upon the size of the lesion site. Assure that enough is applied to adequately cover each lesion. Normally 0.5 g of gel is used on each 5 cm x 5 cm lesion site.
16105645|NCT02120911|Drug|Pertuzumab, trastuzumab|Pertuzumab and trastuzumab will be combined with standard chemoradiation with carboplatin and paclitaxel.
16105646|NCT02120898|Drug|Imiquimod|Cream, generic formulation of the brand product.
16105647|NCT02120898|Drug|Zyclara®|Cream, brand product.
16105648|NCT02120898|Drug|Vehicle Cream|Vehicle cream in the same image of the generic imiquimod. Has no active ingredient.
16107575|NCT02107131|Drug|Intravitreal ranibizumab 0.3mg|
16105649|NCT02120885|Behavioral|physical activity intervention|Exercise program is scheduled to be conducted in three phases. Phase I is in-hospital exercise program. This program will be conducted in hospital during 1 week after surgery. Phase II is home-exercise program that will be performed at home during 1 week after discharge. Phase III is main-exercise program that will be conducted the fitness center nearby hospital during 8 weeks after phase II program. Main-exercise program is focused on the functional recovery.
16105650|NCT02120872|Drug|Platelet rich fibrin and simvastatin|Three wall intrabony defect sites treated with Open Flap Debridement. 0.1 mL prepared SMV gel (1.2 mg/0.1 mL) was mixed with PRF. The PRF - SMV mixture was delivered to the defect.
16105651|NCT02120872|Biological|Platelet rich fibrin|Three wall intrabony defect sites treated with Open Flap Debridement. PRF was placed into the intrabony defect.
16105652|NCT02120872|Procedure|Open Flap Debridement alone|Three wall intrabony defect sites treated with Open Flap Debridement only. No PRF or SMV was delivered to the defect.
16105653|NCT02120859|Device|FFR - guided DEB angioplasty|DEB-only angioplasty is attempted in all patients. At baseline, quantitative coronary angiography (QCA) and fractional flow reserve (FFR) using an intracoronary standard bolus of adenosine are performed. If FFR at baseline is greater than 0.8, PCI is deferred, otherwise predilation with a non-coated balloon is performed. In case of severe recoil (> 50% residual stenosis) or flow-limiting dissection the procedure is deemed not suitable for DEB-only angioplasty and stent implantation is performed at the discretion of the operator. In all other cases, the lesion is treated using a Sequent Please® paclitaxel-eluting balloon (DEB). QCA and FFR measurements are repeated and the result is considered satisfactory if there is no flow-limiting dissection, residual stenosis < 40% and FFR > 0.8.
16105654|NCT02120859|Device|Provisional bare metal stenting|In case of suboptimal results after the FFR-guided DEB angioplasty described above, a bare metal stent is implanted inside the segment previously treated by DEB.
16105655|NCT02120846|Other|Flywheel leg-press resistance exercise|
16105656|NCT02120833|Device|EpiCeram® Skin Barrier Emulsion|Device (including sham) Apply in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin as directed.
16105657|NCT02120833|Drug|Colloidal Oatmeal Cream|Drug (including placebo) Apply in a thin layer to the affected skin areas 2 times per day (or as needed) and massage gently into the skin as directed.
16105658|NCT02120820|Behavioral|Multisensory environment (MSE)|Participants are staying in multisensory environment (MSE only) for 30 minutes in each session, and twice per week for 10 weeks. An enabler stays with the participant throughout the session.
16105659|NCT02120820|Behavioral|Massage therapy (MT)|A trained massage therapist provides 15 minutes massage therapy (MT) to the participants, twice a week for 10 weeks. The massage therapist acts as an enabler.
16105660|NCT02120820|Other|Control group|Usual residential care will be given to these participants. Only attention and social interactions from the enabler will be provided.
16105661|NCT02120820|Behavioral|Massage therapy in multisensory environment (MT-MSE)|Participants receive 15 minutes massage therapy while staying in multisensory environment for 30 minutes, twice a week for 10 weeks.
16105662|NCT02120807|Drug|Certolizumab|
16105663|NCT02120807|Drug|cisplatin|
16105664|NCT02120807|Drug|pemetrexed|
16105665|NCT02120794|Device|530G Insulin pump|Subjects will use 530G insulin pump with Threshold Suspend (TS) feature for one year.
16105666|NCT02120781|Biological|Azficel-T (autologous fibroblasts)|"Autologous fibroblasts will be cultured from three 3-mm post auricular punch biopsies. Biopsies will be shipped from the clinical sites to the Fibrocell manufacturing site where the cells will be harvested, tested for sterility, endotoxin level, cell identity, viability and concentration. When the desired cell number is reached, cells will be transported to the investigative site as a suspension in shipping media.
~Depending upon the clinical circumstances for each subject, the vocal fold(s) will be injected transorally or percutaneously in order to deposit 1.0 mL of study drug into the lamina propria layer of each vocal fold. The injection process will be visualized via a flexible fiberoptic laryngoscope inserted through the nostril."
16105667|NCT02120781|Drug|Placebo|Subjects randomized to placebo will receive injections of sterile saline into the vocal fold(s).
16105668|NCT02120768|Procedure|barrier resection/1cm resection|"For Arm Barrier resection, if a recurrence occurs, patients would be assigned to 1cm resection for their recurrent sarcomas; For Arm 1cm resection, if a recurrence occurs, patients would be assigned to barrier resection for their recurrent sarcomas."
16105669|NCT02120755|Biological|AmnioClear™ Human Allograft Amniotic Membrane|
16105670|NCT02120742|Behavioral|SMS message reminder|SMS texts will be delivered to study participants over a 6-week period.
16105671|NCT02120729|Other|Genotype-guided care|Pharmacogenetic alerts are furnished to the clinician within 2 days of admission. Buccal cell DNA is analyzed for 21 common CYP2D6 polymorphisms and results quantified into a drug metabolism reserve index to establish levels of sub-normal function (poor metabolizer) or supra-normal function (rapid metabolizer). For the estimated 50% of patients who are poor or rapid metabolizers, CEMS will proscribe medications which are major CYP2D6 substrates.
16105672|NCT02120716|Behavioral|Health Check-Up for Expectant Moms|Participants randomly assigned to the treatment condition will receive a 60-minute brief intervention on the Tablet after the baseline assessment. The software will personalize the intervention content based on the current risk status of each participant and will include a plan addressing endorsed risks. Within one month of baseline, there will be a 15-20 minute, computer-delivered booster session reviewing the personalized plan and identifying barriers in the reduction or risks and/or meeting the goals in the plan.
16105673|NCT02120703|Drug|Pregabalin|Pregablin 75 mg per oral two times a day
16105674|NCT02120703|Drug|Gabapentin|Gabapentin 200 mg twice daily per oral
16105675|NCT02120690|Device|Trigeminal nerve stimulation|10-day TNS interventional protocol over an 10-day follow-up. Subjects will have electrodes (Superior Silver 1.25-in. diameter) placed on their foreheads to stimulate the V1 branches of the trigeminal nerve bilaterally for approximately 30 minutes each day. Current was adjusted to maintain comfortable but perceptible levels of stimulation
16105743|NCT02120183|Behavioral|Psycho-educational support group therapy|"Weekly sessions lasting 60 minutes. Topics addressed each week:
~Week 1: Coping with the diagnosis of loved one and dealing with uncertainty
~Week 2: Caring for the carer 1: Feeding your body (self-care, stress management, mindfulness concepts)
~Week 3: Caring for the carer 2: Feeding your mind (challenging negative thinking habits)
~Week 4: The emotions of caregiving (handling emotional reactivity)"
16105676|NCT02120677|Drug|Itraconazole|Itraconazole comes in the form of capsules and liquid (oral solution). It is FDA approved for treatment of systemic Blastomycosis, Histoplasmosis and Aspergillosis in immunocompromised and non-immunocompromised patients at doses ranging from 200mg to 400mg daily. The current FDA approved dosage recommendation for treating toenail onychomycosis (nail fungus) is 200mg PO per day for 3 months. Test materials in this study will be prepared as an ointment (compounded in petrolatum jelly).
16105677|NCT02120664|Drug|Florbetapir (18F)|
16105678|NCT02120664|Drug|11C-PiB|
16105679|NCT02120651|Procedure|Fibrin monomer|Fibrin monomer by microscopic tympanoplasty, every 4 weeks up to 3 months is evaluated graft integrity by standard audiologic and tympanometric parameters.
16105680|NCT02120651|Procedure|Hemostatic sponge|Hemostatic sponge by microscopic tympanoplasty, every 4 weeks up to 3 months is evaluated graft integrity by standard audiologic and tympanometric parameters.
16105681|NCT02120638|Drug|Pyrazinamide containing regimen|Pyrazinamide 33-50kg 1000-1750 mg daily, 51-70kg 1750-2000 daily, >70kg 2000-2500mg daily Amikacin 600mg daily Levofloxacin 33-70kg 750 mg daily, >70kg 1000 mg daily Clarithromycin 33-50kg 500 mg daily, >50kg 1000 mg daily Prothionamide 33-50kg 500 mg daily, 51-70kg 750 daily, >70kg 1000 mg daily All treatment is taken daily, for a duration of up to 12 months depending on treatment arm.
16105682|NCT02120638|Drug|Regimen without Pyrazinamide|Isoniazid 600mg daily Amikacin 600mg daily Levofloxacin 33-70kg 750 mg daily, >70kg 1000 mg daily Clarithromycin 33-50kg 500 mg daily, >50kg 1000 mg daily Prothionamide 33-50kg 500 mg daily, 51-70kg 750 daily, >70kg 1000 mg daily All treatment is taken daily, for a duration of up to 18 months depending on treatment arm.
16105683|NCT02120625|Device|Lumbar MB RFN|Patients will be placed in a prone position and prepped. The C-arm will be adjusted to establish a true anteroposterior image of the target vertebra. The C-arm will then be rotated until the target point at the base of the SAP is clearly visualized. The Nimbus probe, with the tines (filaments) in the retracted position, will be inserted and advanced to the bony target site using a down the beam approach. The probe hub will be rotated to accomplish a full deployment of the tines with a medial or lateral angular bias, as dictated by the SAP anatomy and angle of entry of the NMEE probe. Motor stimulation at 2 Hz up to 2 volts will be administered (safety check). The lesion site will be anesthetized before the radiofrequency (RF) generator is set to achieve a temperature of 80°C for 80 seconds, following 30 second temperature ramp up. Impedance and power will be recorded.
16105684|NCT02120612|Other|Naloxone Education Intervention|"The Naloxone Education Intervention is a curriculum that has been adapted from New York State Department of Health's, Opioid Overdose Prevention program for non-medical responders."
16105685|NCT02120599|Dietary Supplement|ready-to-use supplementary food|
16105686|NCT02120599|Dietary Supplement|corn-soy blend|
16105687|NCT02120599|Dietary Supplement|iron|
16105688|NCT02120599|Dietary Supplement|folic acid|
16105689|NCT02120599|Dietary Supplement|UNIMMAP|
16105690|NCT02120586|Other|Inspiratory Muscle Training (IMT).|"Supervised interval-based program consisting of seven cycles of 2-minutes work and 1-minute rest. This protocol is published as a practical guide for clinicians by Hill et al (2010).
~The sessions will take place 3 times per week over a twelve-week period for a total of 36 sessions. All participants will be familiarized with the breathing exercises over a two-week familiarization period at the beginning of the protocol. The load will be adjusted at ≥ 50% of baseline MIP. Participants remain seated in groups of 8 to 10."
16105691|NCT02120586|Other|Peripheral muscle training|"The supervised training program consists of one cycle of 10 exercises, 12 repetitions each one. The main peripheral muscles to be trained will be those recommended by Cruz-Jentoft et al (2011): brachial biceps and triceps, pectorals, deltoid, hand flexors and extensors, spine extensor muscles, psoas-iliac, quadriceps femoris and sural triceps.
~The sessions will take place 3 times per week over a twelve-week period for a total of 36 sessions. All participants were familiarized with the force exercises over a two-week familiarization period at the beginning of the protocol. The load will be adjusted at ≥ 50% of maximum muscle force. Participants remain seated in groups of 8 to 10."
16105692|NCT02120573|Other|Workshop using Lecture and human model|workshop to teach CPR with lecture and human models
16105693|NCT02120573|Other|Workshop using Educational Film|workshops using film review about CPR
16105694|NCT02120573|Other|Workshop using Lecture, human model as well as Educational Film|using educational films and human model and lecture for training
16105695|NCT02120573|Other|Workshop using Lecture, human model, Educational Film as well as reference book|training volunteers with lecture, films, and human models and giving them reference book for referral
16105696|NCT02120560|Procedure|Atrial Fibrillation Ablation|Both treatment arms will undergo atrial fibrillation ablation.
16105697|NCT02120547|Drug|Cenicriviroc in mild liver impaired|Subjects with mild hepatic impairment will receive CVC, 1 tablet once daily, for 14 days. Matching healthy subjects will receive CVC, 1 tablet once daily, for 14 days.
16105698|NCT02120547|Drug|Cenicriviroc in moderate liver impaired|Subjects with moderate hepatic impairment will receive CVC, 1 tablet once daily, for 14 days. Matching healthy subjects will receive CVC, 1 tablet once daily, for 14 days.
16105699|NCT02120508|Device|rTMS|To test the efficacy of this specific setting.
16105700|NCT02120495|Procedure|condylectomy|The condylectomy via intraoral approach will avoid the risk of facial nerve injury and skin scar compared with the preauricular incision.And it can also greatly reserve the temporomandibular jiont anatomy and function.
16105701|NCT02120482|Device|Combined apheresis|Semiselective immunoadsorption combined with membrane filtration
16105702|NCT02120469|Drug|everolimus|Given PO
16105703|NCT02120469|Drug|eribulin mesylate|Given IV
16105704|NCT02120469|Other|pharmacological study|Correlative studies
16105705|NCT02120469|Other|laboratory biomarker analysis|Optional correlative studies
16105706|NCT02120456|Drug|LEO 43204|
16105707|NCT02120456|Drug|Placebo|
16105708|NCT02120443|Device|ivWatch Model 400|The ivWatch Model 400 monitored tissue at common IV sites over a 24 hour period.
16105744|NCT02120170|Procedure|Colon polypectomy|
16105745|NCT02120157|Drug|Cyclophosphamide|Chemotherapy administration
16105746|NCT02120157|Radiation|TBI|Radiation Therapy
16105747|NCT02120157|Drug|Busulfan|Chemotherapy Administered
16105748|NCT02120157|Other|Unmanipulated Bone Marrow|Bone Marrow Transplant
16105749|NCT02120157|Drug|Tacrolimus|Immunosuppressive Drug Administered
16105709|NCT02120430|Other|Video|"The video was developed by a multidisciplinary team (psychologists, paediatricians, filmmaker). It was conceived as an aid to parenting in the first year of life, providing opportunities for parents to look at their own experiences. The video lasts 24 minutes and describes the birth of a new relationship between primary caregivers and their babies, in chronological order, starting from late pregnancy to the end of the first year. Caregiver-child interactions are shown from early contact after delivery to common care practices, with an emphasis on four specific activities, which are believed to improve child development and caregiver-child interaction: reading aloud to the baby, exposure to songs, rhymes and music, promotion of early socialization for parents and for children."
16105710|NCT02120417|Drug|Ruxolitinib|"5 mg tablets to be administered by mouth
~Ruxolitinib 15 mg BID (starting dose)"
16105711|NCT02120417|Drug|Capecitabine|Capecitabine 2000 mg/m^2 daily given as 1000 mg/m^2 twice a day (BID) (starting dose) Day 1-14 of each 21 day cycle
16105712|NCT02120417|Drug|Placebo|5 mg matching placebo tablets to be administered by mouth
16105713|NCT02120404|Drug|Esmolol administration|"Esmolol will be administered during 24 hours, beginning with a titration period to determine the minimal dose allowing to achieve the randomized heart rate reduction of 10% or 20%, as defined by randomization.
~Titration will be performed in sequences of increasing doses, beginning with 5 μg/kg/min as initial dose, and increasing by 5 μg/kg/min each 30 minutes until the target heart rate reduction is obtained. The maximum dose is 200 μg/kg/min.
~The titrated dose will be maintained for a total duration of 24 hours."
16105714|NCT02120391|Other|iPhone Application|All subjects will receive the iPhone App on their phone however not all subjects will have the intervention (medication notifications) turned on.
16105715|NCT02120365|Drug|Perampanel|Perampanel is a noncompetitive (allosteric) antagonist of the AMPA-R that is well-absorbed (100% bioavailability), has good blood-brain-barrier penetration, and rapidly reaches peak plasma concentrations (1 hour). To date, there have been no clinical trials of AMPA-R antagonists (e.g., perampanel) for the treatment of alcoholism.
16105716|NCT02120365|Drug|Placebo|Placebo given in place of perampanel during the pre-treatment period and lab session days.
16105717|NCT02120352|Drug|GSK744|White to almost white oval shaped film coated 30 mg tablets for oral administration.
16105718|NCT02120352|Drug|GSK744 LA|Sterile white to slightly colored suspension containing 200 mg/mL of GSK744 as free acid (GSK1265744 free acid), polysorbate 20, polyethylene glycol 3350, mannitol, and water for injection, packaged in a 3 mL USP Type I glass vial, for administration by IM injection
16105719|NCT02120352|Drug|TMC278 LA|Sterile white suspension containing 300 mg/mL of TMC278 as free base, poloxamer 338, sodium dihydrogen phosphate monohydrate, citric acid monohydrate, glucose monohydrate, sodium hydroxide, water for injection, packaged in a 2 mL USP Type I glass vial, for administration by IM injection.
16105720|NCT02120352|Drug|ABC/3TC|ABC/3TC fixed dose combination (FDC) oral tablet, containing 600 mg of ABC (as abacavir sulfate) and 300 mg of 3TC
16105721|NCT02120352|Drug|RPV|Off-white, round, biconvex, film-coated 25 mg Rilpivirine (RPV) tablets for oral administration. Eligible subjects switching from the oral regimen to the IM regimen in the Extension Period will receive 2 weeks of RPV 25 mg once daily, from Week 102 through Week 104
16105722|NCT02120339|Drug|Carvedilol|
16105723|NCT02120326|Device|Transcranial direct current stimulation of the motor cortex|"The area of stimulation is determined by by EEG system 10/20. The two electrodes are soaked in saline and then placed on the scalp.
~Stimulation parameters:
~2 mA intensity
~Continuous stimulation for 20 min with rise times and fall times of 10 seconds each"
16105724|NCT02120326|Device|simulation of Transcranial direct current stimulation of the motor cortex|"The area of stimulation is determined by by EEG system 10/20. The two electrodes are soaked in saline and then placed on the scalp.
~Stimulation parameters:
~The intensity of the stimulation current is 2 mA
~The current is applied during the first 30 seconds with rise times and fall times of 10 seconds each. Then the session will be continued without actual stimulation."
16105725|NCT02120313|Other|inpatient rehabilitation|
16105726|NCT02120313|Other|outpatient rehabilitation|
16105727|NCT02120300|Drug|LDV/SOF|90/400 mg FDC tablet administered orally
16105728|NCT02120300|Drug|SOF|400 mg tablet administered orally once daily
16105729|NCT02120300|Drug|RBV|Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16105730|NCT02120287|Drug|Bevacizumab|Patients will receive bevacizumab (10 mg/kg) one day before and then at day 14 followed by10 mg/kg/day every 14 days until progression.
16105731|NCT02120287|Procedure|Magnetic Resonance Spectroscopy (MRS)|Subjects will have MRS prior to BZ-SRS.
16105732|NCT02120287|Procedure|Border Zone Stereotactic Radiosurgery (BZ-SRS)|The 'border zone' of the tumor will be targeted by SRS in a single session.
16105733|NCT02120274|Drug|Vitamin D|Oral vitamin D 2,000 IU qd throughout, irrespective of baseline vitamin D level.
16105734|NCT02120274|Drug|Vitamin B 12|Intramuscular vitamin B12 5000 UI will be given weekly in the first 12 weeks followed by a monthly injection until the end of therapy.
16105735|NCT02120261|Drug|Normal Saline|Trigger point injection (TPI) with 1 mL of normal saline solution. Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.
16105736|NCT02120261|Drug|Lidocaine Hydrochloride|Trigger point injection (TPI) with 1 mL of conventional drug mix (lidocaine 1%; 10 mL+ triamcinolone acetonide 40 mg/mL). Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.
16105737|NCT02120261|Drug|Triamcinolone acetonide|Trigger point injection (TPI) with 1 mL of conventional drug mix (lidocaine 1%; 10 mL+ triamcinolone acetonide 40 mg/mL). Trigger point injection involves a single injection in the area of maximal tenderness or trigger point. This will be performed by the treating physician under sterile technique with a 25 gauge needle.
16105738|NCT02120248|Other|Telephone-based breastfeeding peer counseling|
16105739|NCT02120222|Drug|selinexor|Given PO
16105740|NCT02120222|Other|Correlative studies|Blood will be collected for pK and pDn analysis pretreatment on day 1 and 8 hours after treatment, on day 1 of cycles 1 and 2.
16105741|NCT02120196|Drug|Rifaximin|rifaximin 1200 mg daily versus norfloxacin 400 mg once daily
16105742|NCT02120196|Drug|Norfloxacin|FDA approved:400mg once daily
16105750|NCT02120157|Drug|Mycophenolate mofetil|Immunosuppressive Drug Administered
16105751|NCT02120144|Other|Observation & imagination|It is a combination of an observation phase followed by an immediate imagination phase of a straight gait with an imposed cadency.
16105752|NCT02120144|Other|Reading|"A 10 minutes reading phase of François Mauriac's Therese Desqueyroux on a computer"
16105753|NCT02120118|Radiation|Radiation|2Gy/5fx/week for a subtotal of 40Gy/20fx/4 weeks, followed by reduced-field boost with 10Gy/2fx/2 weeks (5Gy once a week during 5th and 6th week), totalling 50Gy/22fx/6 weeks.
16105754|NCT02120118|Other|Hyperthermia|42℃ ± 0.5℃ for 40 minutes within 2hr after irradiation, once a week since the 1st week of radiation for a total of 6 times
16105755|NCT02120118|Drug|Cisplatin|30mg/m2
16105756|NCT02120118|Drug|Taxotere|20mg/m2
16105757|NCT02120092|Drug|Clopidogrel|1x Loading dose 600 mg 6x maintenance dose 150 mg
16105758|NCT02120092|Drug|Ticagrelor|1x Loading dose: 180 mg 6x Maintenance dose: 90 mg bid
16105759|NCT02120092|Drug|ASA|"7x 100mg acetylsalicylic acid (clopidogrel arm)
~1x 300 mg acetylsalicylic acid (ticagrelor arm)"
16105760|NCT02120092|Drug|Placebo|7x 300mg acetylsalicylic acid placebo
16105761|NCT02120079|Drug|Lotemax|Lotemax (loteprednol etabonate) 0.5% will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.
16105762|NCT02120079|Drug|Soothe Tired Eyes Lubricant Eye Drop (Artificial Tears)|Soothe Tired Eyes Lubricant Eye Drop will be applied topically to both eyes for 6 weeks with the following regimen: four times a day for 2 weeks, twice daily for 2 weeks, and once daily for 2 weeks.
16105763|NCT02120079|Diagnostic Test|In Vivo Confocal Microscopy (IVCM)|In vivo confocal microscopy (IVCM) is a new imaging method, which allows visualization of the corneal structures at the cellular level. With a magnification of 800 times, it makes it possible to detect and quantify changes in the epithelial layers and sub-basal nerve plexus.
16105764|NCT02120066|Procedure|Vitrectomy for submacular hemorrhage|
16105765|NCT02120066|Drug|subretinal injection of tissue-plasminogen activator|
16105766|NCT02120053|Device|Conventional protocol|Teeth extractions and conventional immediate complete denture placement
16105767|NCT02120053|Device|Bone substitute material group|Teeth extractions and sockets filling with bone replacement material before immediate complete denture placement
16105768|NCT02120040|Other|evaluation of anxiety with psychosocial scales|
16105769|NCT02120027|Drug|Ibodutant 10 mg|Oral tablet, to be given once daily.
16105770|NCT02120027|Drug|Placebo|Oral tablet (identical in appearance and weight to ibodutant tablets) to be given once daily.
16105771|NCT02120014|Procedure|blood volume measurement|"Patients will drink a solution 30 minutes prior to the test. They will need to lie still on a flat surface for 15 minutes. During the blood volume analysis portion of the test, a small amount of a radioactive isotope or tracer is injected.Blood samples are taken at 6 time points during the test. The blood volume test is used to measure the amount of blood in the patients body.
~A hematocrit measurement is done on the blood samples taken. This blood test calculates the percentage of red blood cells in the bloodstream."
16105772|NCT02120014|Procedure|venous plethysmography|venous plethysmography is a non-invasive test to measure how well your veins and arteries in your forearm and calf work. Cuffs similar to blood pressure cuffs are placed on the upper and lower arm and the thigh and calf. Measurements are taken
16105773|NCT02120001|Device|ETT cleaning maneuver|"EndOclear is a commercially available device. It consists of an endotracheal tube cleaning apparatus with a flexible central tube and a cleaning device at its distal end. In operation, the collapsed cleaning apparatus is inserted into the ETT through a Y-shaped connector. The device is then expanded by a safety toggle protected trigger mechanism that, when fired, presses the device's smooth silicone disc against the inside surface of the endotracheal tube. The cleaning apparatus is then pulled out of the endotracheal tube removing mucus deposits and secretions.
~We plan to add the use of endOclear to the standard ICU practice, scheduling the systematic use of the device every 8 hours for the whole intubation period."
16105774|NCT02119988|Procedure|TIPS|TIPS was performed in a conventional fashion or in combination of percutaneous transhepatic or transsplenic approach. TIPS revision was planned if any evidence of shunt dysfunction was seen.
16105775|NCT02119988|Procedure|Embolization|Embolization of gastroesophageal collaterals was conducted via the same jugular vein before TIPS implantation. The major procedures included (a)angiography of gastroesophageal collaterals after successful intrahepatic puncture of a branch of the portal vein and (b)embolization of SPSS with coils of varying diameters, which resulted in the gastroesophageal collaterals disappearing at postembolization angiography.
16105776|NCT02119975|Behavioral|Working memory training|
16105777|NCT02119975|Behavioral|Placebo training|
16105778|NCT02119962|Behavioral|Working memory training|
16105779|NCT02119962|Behavioral|Placebo training|
16105780|NCT02119949|Behavioral|Working memory training|The working memory training started the day after the pre-test and included 24 sessions of 25 minutes each. Participants trained, under supervision of an experimenter, on weekdays in the clinic. The training consisted of two tasks: the Symmetry Span and the N-back Task. Participants in the experimental group executed versions of these task that adapt to their working memory capacity, to train their working memory optimally.
16105781|NCT02119949|Behavioral|Placebo training|The working memory training started the day after the pre-test and included 24 sessions of 25 minutes each. Participants trained, under supervision of an experimenter, on weekdays in the clinic. The training consisted of two tasks: the Symmetry Span and the N-back Task. Participants in the placebo group executed easy versions of these task that did not adapt to their level, to prevent training.
16105782|NCT02119936|Behavioral|Heart Rate Variability Biofeedback Tool|The Heart Rate Variability Biofeedback tool (emWave 2) will capture heart rate variability (HRV) before and after deep breathing exercises are used among participants. Participants will be able to visualize changes in their HRV and then fill-out self-reported anxiety measures to determine if the breathing exercises and visualization of HRV affected anxiety.
16105828|NCT02119611|Device|Deep Brain Stimulation Management|The DBS surgery will be performed according to standard of care in the centers of referral. If performed at the NIH, this will be done under protocol 11-N-0211 or other protocols permitting DBS surgery depending on future availability.
16105829|NCT02119572|Behavioral|peer support|
16105830|NCT02119572|Other|usual education lectures|
16105783|NCT02119923|Behavioral|Working memory training|The WM consisted of two tasks; the Number-letter task (Rogers & Monsell, 1995) and an Updating task. The Number-letter task trains the ability to shift between task relevant stimuli. Participants need to shift between four categories. In the Updating task participants receive a set of three words in which they have to compare the two consecutive words on emotional valence (positive or negative) to train their updating skills. Participants executed the training three times a week during four weeks.
16105784|NCT02119923|Behavioral|Placebo training|Both the WM and the placebo training consisted of two tasks; the Number-letter task (Rogers & Monsell, 1995) and an Updating task. To prevent training WM the placebo training was a simplified version of the Number-letter task in which shifting was not required. In the Updating task the placebo group only had to count the number of positive or negative words. Participants executed the training three times a week during four weeks.
16105785|NCT02119910|Behavioral|Technology Supported Manual|
16105786|NCT02119897|Device|Low Level Light Therapy|
16105787|NCT02119884|Drug|Terlipressin|Patients in the terlipressin group receive a single IV injection of 2 mg of terlipressin and a continuous IV infusion of normal saline.
16105788|NCT02119884|Drug|Octreotide|Patients in high dose octreotide receive a single injection of 100μg octreotide and continuous IV infusion of 50 μg/h of octreotide.
16105789|NCT02119871|Procedure|Bilateral Open Pleurae|Both pleurae are opened Right pulmonary vein drainage
16105790|NCT02119871|Procedure|Right Pleura Open|Right pleura open Left ventricular apical drainage
16105791|NCT02119858|Drug|indocyanine green solution|Given transperineally
16105792|NCT02119858|Other|diffuse optical imaging|Undergo near infrared fluorescence imaging
16105793|NCT02119858|Procedure|robot-assisted laparoscopic surgery|Undergo robot-assisted laparoscopic radical prostatectomy
16105794|NCT02119858|Procedure|therapeutic lymphadenectomy|Undergo lymphadenectomy
16105795|NCT02119845|Device|Endovascular AVF (EndoAVF)|The FLEX System will be used to endovascularly create a fistula in CKD patients who require hemodialysis vascular access.
16105796|NCT02119832|Device|Endovasccular AVF (EndoAVF)|The FLEX System will be used to endovascularly create a fistula in CKD patients who require hemodialysis vascular access
16105797|NCT02119819|Drug|LY2944876|Administered SC
16105798|NCT02119819|Drug|Exenatide extended-release|Administered SC
16105799|NCT02119819|Drug|Placebo|Administered SC
16105800|NCT02119819|Drug|Metformin|Oral
16105801|NCT02119806|Drug|Benzodiazepine|Receive as premedication in the Benzodiazepine group.
16105802|NCT02119806|Drug|Fentanyl|Receive as maintenance in the Benzodiazepine group. Can receive as premedication in the Non-Benzodiazepine group. Receive as maintenance in the Non-Benzodiazepine group.
16105803|NCT02119806|Drug|Propofol|Receive postoperatively in the Benzodiazepine group. Can receive as premedication in the Non-Benzodiazepine group. Receive postoperatively in the Non-Can receive as premedication in the Non-Benzodiazepine group.
16105804|NCT02119793|Device|YVOIRE contour|YVOIRE contour injection into the anteromedial malar region
16105805|NCT02119780|Device|YVOIRE® contour|YVOIRE® contour injection into the anteromedial malar region
16105806|NCT02119780|Device|Restylane SubQ™|Restylane SubQ™ injection into the anteromedial malar region
16105807|NCT02119754|Drug|Plurogel PN|
16105808|NCT02119728|Drug|HPPH|Undergo photodynamic therapy with HPPH
16105809|NCT02119728|Device|Light Infusion Therapy™|Undergo photodynamic therapy with HPPH
16105810|NCT02119728|Procedure|therapeutic conventional surgery|Undergo standard of care surgery
16105811|NCT02119715|Drug|Pegylated rhG-CSF 100μg/kg|Patients were administered pegylated rhG-CSF 100 ug/kg once at the 3rd day of 2 to 4 chemotherapy cycle(epirubicin 75mg/m2+docetaxel 75mg/m2 for neoadjuvant therapy and epirubicin 100mg/m2+cyclophosphamide 600mg/m2 for adjuvant therapy).
16105812|NCT02119715|Drug|Pegylated rhG-CSF:150 μg/kg|Patients were administered pegylated rhG-CSF 150 ug/kg once at the 3rd day of 2 to 4 chemotherapy cycle(epirubicin 75mg/m2+docetaxel 75mg/m2 for neoadjuvant therapy and epirubicin 100mg/m2+cyclophosphamide 600mg/m2 for adjuvant therapy).
16105813|NCT02119715|Drug|rhG-CSF 5 μg/kg/day|Patients were administered rhG-CSF 5 ug/kg daily during chemotherapy cycle(epirubicin 75mg/m2+docetaxel 75mg/m2 for neoadjuvant therapy and epirubicin 100mg/m2+cyclophosphamide 600mg/m2 for adjuvant therapy) until (1)continuous injection for 14 days (2)two successive ANC counts exceed 5.0×109/L（3）ANC counts exceed 15×109/L at anytime.
16105814|NCT02119689|Other|Diabetic Patients|measuring CD34 cell function in relation to diabetic retinopathy status
16105815|NCT02119689|Other|Healthy Controls|measuring CD34 cell function
16105816|NCT02119676|Drug|Ruxolitinib|"5 mg tablets to be administered by mouth
~Ruxolitinib 20 mg twice a day (BID) (Part 1) (NOTE: The starting dose for the randomized portion of study (Part 2) was 15 mg BID based on results from Part 1.)"
16105817|NCT02119676|Drug|Regorafenib|Regorafenib 160mg once daily for the first 21 days of each 28-day cycle. (NOTE: Dose interruptions and modifications for regorafenib are expected when toxicities occur in which dose interruptions or modifications are appropriate.)
16105818|NCT02119676|Drug|Placebo|5 mg matching placebo tablets to be administered by mouth
16105819|NCT02119663|Drug|Ruxolitinib|5 mg tablets to be administered by mouth twice daily (BID)
16105820|NCT02119663|Drug|Placebo|5 mg matching placebo tablets to be administered by mouth twice daily (BID)
16105821|NCT02119663|Drug|Capecitabine|150 mg or 500 mg tablets to be administered by mouth twice daily (BID)
16105822|NCT02119650|Drug|Ruxolitinib|5 mg tablets to be administered by mouth at dose selected from safety run-in phase (Ruxolitinib 15 mg twice daily (BID))
16105823|NCT02119650|Drug|Placebo|5 mg matching placebo tablets to be administered by mouth
16105824|NCT02119650|Drug|Pemetrexed|500 mg/m^2 administered as an intravenous infusion over 10 minutes
16105825|NCT02119650|Drug|Cisplatin|75 mg/m^2 infused over 2 hours beginning 30 ± 5 minutes after the end of the pemetrexed infusion
16105826|NCT02119637|Device|Transcranial magnetic stimulation (TMS)|1 Hz rTMS for 20 minutes. TMS sessions were separated by at least 24 hours.
16105827|NCT02119637|Device|MRI|Anatomical MRI, resting state MRI and functional MRI using gentle brushing and finger movement
16105831|NCT02119559|Other|Blood analysis by EPISPOT and CellSearch®|
16105832|NCT02119546|Other|Aerobic exercise|Aerobic exercise and dual-task training
16105833|NCT02119546|Other|Stretch exercise|Stretch exercise & sitting balance
16105834|NCT02119520|Drug|Platelet rich fibrin +Atorvastatin|
16105835|NCT02119520|Drug|Platelet rich fibrin|
16105836|NCT02119520|Procedure|open flap debridement|
16105837|NCT02119507|Device|Curodont Repair|Single application on Day 0
16105838|NCT02119507|Other|No treatment - control|
16105839|NCT02119481|Behavioral|Mindfulness-based stress reduction|
16105840|NCT02119481|Behavioral|Expressive writing condition|
16105841|NCT02119468|Drug|ixazomib citrate|Given orally
16105842|NCT02119468|Drug|dexamethasone|Given orally
16105843|NCT02119468|Drug|pomalidomide|Given orally
16105844|NCT02119455|Device|Vibration Device|Subjects receiving the OrthoAccel Aura device will be instructed to use the device for 20 minutes/day per the manufacturer's instructions during the study period.
16105845|NCT02119442|Device|Transcather Valve Implantation|Transcather Valve Implantation
16105846|NCT02119429|Dietary Supplement|Pumpkin Seed Oil|2 grams per day, everyday for 12 weeks.
16105847|NCT02119429|Dietary Supplement|Wheat Germ Oil|2 grams per day, everyday for 12 weeks.
16105848|NCT02119416|Drug|Placebo Administration first|"All participants received each dose on two days and the order of administration was counterbalanced.
~Order of Administration for Visits 1-6: 0mg, 1mg, 2mg, 0mg, 1mg, 2mg"
16105849|NCT02119416|Drug|Low Caffeine Administration first (1mg/kg body weight)|"On two of the 6 visits, participants received a placebo (flattened sprite) added to their beverage.
~Order of Caffeine Administration for Visits 1-6: 1mg, 2mg, 0mg, 1mg, 2mg, 0mg"
16105850|NCT02119416|Drug|High Caffeine Administration first (2mg/kg body weight)|"On two of the 6 visits, participants received a placebo (flattened sprite) added to their beverage.
~Order of Caffeine Administration for Visits 1-6: 2mg, 0mg, 1mg, 2mg, 0mg, 1mg"
16105851|NCT02119403|Other|There are no other inteventions.|This device gives patients the opportunity to receive nitrous oxide where no such opportunity exists. There is no other intervention available that creates immediate short term minimal sedation.
16105852|NCT02119390|Behavioral|Staff-delivered intervention sessions|In addition to standard clinical care, participants in the Pill Trial+ arm will receive staff-delivered intervention sessions individualized for each participant at HAART initiation, 1-month, and 3-month follow-up. Two booster sessions will also be provided at two weeks following intervention session 1 (in clinic) and intervention session 2 (by phone) to assess any difficulties using the created adherence plans.
16105853|NCT02119390|Other|Demographic Questionnaire|Participants will complete a questionnaire developed for the purposes of the current study assessing basic background information.
16105854|NCT02119390|Other|Questionnaires|Self-reported adherence, health-related quality of life and other questionnaire measures will be administered using a password protected laptop the same day as participants' regularly scheduled outpatient clinic appointments.
16105855|NCT02119377|Other|questionnaire|
16105856|NCT02119364|Other|Working memory training|The child will use the computer program at home under parental supervision for 25 sessions, each lasting 30-45 minutes and the family has 6 weeks to complete the training. Each session consists of 8 different tasks presented by an animated robot. The tasks all require the child to hold information in working memory and to manipulate the information.
16105857|NCT02119351|Device|ViaValve™ Safety IV Catheter|Safety peripheral IV catheter with a blood control feature
16105858|NCT02119351|Device|ProtectIV® Plus Safety IV Catheter|Safety peripheral IV catheter with no blood control feature
16105859|NCT02119338|Drug|5-ala|dose of 5-ala will be taken as either 5 mg/kg, 10 mg/kg, or 20 mg/kg approximately 3 hours before going to surgery.
16105860|NCT02119325|Dietary Supplement|25% fibre|Test is a powdered beverage with an active component of 25% of fibre (resistant maltodextrin)
16105861|NCT02119325|Dietary Supplement|0% fibre|Placebo is an energy matched powdered beverage
16105862|NCT02119299|Device|SMART device|Sensor Monitored Alimentary Restriction Therapy (SMART) device
16105863|NCT02119286|Drug|FF|Dry white powder containing 100mcg of Fluticasone Furoate blended with lactose per blister was administered by DPI.
16105864|NCT02119286|Drug|VI|Dry white powder containing 25mcg of Vilanterol micronised drug (as the 'M' salt triphenylacetate) blended with lactose and magnesium stearate per blister was administered by DPI.
16105865|NCT02119286|Drug|UMEC|Umeclidinium bromide in a powder blend with lactose and magnesium stearate was used at two different doses 62.5mcg and 125mcg.
16105866|NCT02119286|Drug|Placebo|The matching placebo DPI identical in appearance to the inhaler containing active study medication.
16105867|NCT02119273|Drug|Prednisone|See arm description
16105868|NCT02119273|Drug|Placebo|See arm description
16105869|NCT02119260|Drug|GSK2798745 solution|Clear, colourless GSK2798745 (0.1 to 0.4mg) solution in aqueous citrate buffer with 4% captisol
16105870|NCT02119260|Drug|GSK2798745 suspension|Aqueous suspension of GSK2798745 (>=0.5 mg)
16105871|NCT02119260|Drug|GSK2798745 capsule|White Opaque granule filled capsules of GSK2798745 (>=0.5 mg)
16105872|NCT02119260|Drug|Placebo solution|Clear, colourless solution of aqueous citrate buffer with 4% captisol
16105873|NCT02119260|Drug|Placebo suspension|Visually matching aqueous suspension of hypromellose acetate succinate powder
16105874|NCT02119260|Drug|Placebo capsule|Matching white opaque placebo blend filled capsule
16105875|NCT02119247|Device|CHF 6001 dry powder for inhalation via NEXThaler®|
16105876|NCT02119247|Device|CHF 6001 DPI capsules for inhalation via Aerolizer|
16105879|NCT02119221|Drug|Copanlisib (BAY80-6946)|Intravenous infusion of 12 mg copanlisib labeled with 2.76 MBq (75 μCi) of [14C]
16105880|NCT02119208|Behavioral|Intensity and timing of exercise|
16105881|NCT02119195|Procedure|Sealant|resin-based sealant (Clinpro Sealant, 3M ESPE)
16105882|NCT02119182|Behavioral|In-Person Outcome Assessment|NIH Flexible Outcome Assessment Battery Framework Measures In-Person at 2 Weeks, 6 Months, and 12 Months, and by Phone at 3 Months.
16105883|NCT02119182|Behavioral|Phone Outcome Assessment|NIH Flexible Outcome Assessment Battery Framework Measures by Phone at 2 Weeks, 3 Months, 6 Months, and 12 Months.
16105884|NCT02119182|Procedure|3T Magnetic Resonance Imaging (MRI)|3T Research MRI at 2 weeks and 6 months.
16105885|NCT02119182|Procedure|Blood Draw for Plasma, DNA, Serum, RNA|Blood Draw for Plasma, DNA, Serum, RNA at baseline, in hospital (if applicable), 2 weeks, and 6 months (DNA at baseline only).
16105886|NCT02119169|Device|Pigtail catheter|pigtail catheter for pleural drainage
16105887|NCT02119156|Drug|Belimumab|Monthly intravenous infusions dosed as 10 mg/kg body weight
16105888|NCT02119143|Dietary Supplement|vitamines and minerals|given for 24 weeks, after 4 week wash out of all supplements and dietetic products
16105889|NCT02119143|Dietary Supplement|placebo|given for 24 weeks, after 4 weeks wash out of all supplements and dietetic products
16105890|NCT02119130|Device|QGIT|Seven pairs of clinics will be included in this study. One clinic in each pair will be selected by a computerized randomization program to be the standard of care arm (TST only) and the other will be in the QGIT arm.
16105891|NCT02119117|Dietary Supplement|CoQ10|This is a dietary supplement which will be administered daily to the patient for 3 months prior to IVF
16105892|NCT02119117|Dietary Supplement|Placebo|This is a placebo which will be administered daily to the patient for 3 months prior to IVF.
16105893|NCT02119104|Drug|Prevenar (13v)|Prevenar (13v)
16105894|NCT02119091|Drug|Moxifloxacin|
16105895|NCT02119078|Other|Acute Care of Elders focused geriatric care|Patients admitted to the ACE Service will receive standard care as well as additional use of geriatric-specific order sets and protocols and oversight of care by a geriatric-trained Advanced Practice Provider (APP).
16105896|NCT02119065|Procedure|positron emission tomography|Undergo PET/CT scan
16105897|NCT02119065|Procedure|computed tomography|Undergo PET/CT scan
16105898|NCT02119052|Drug|octeotride|
16105899|NCT02119052|Drug|placebo|
16105900|NCT02119039|Device|RGTA OTR 4120 (CACICOL20)|
16105901|NCT02119039|Device|Genteal HA eye drops|
16105902|NCT02119026|Drug|Capecitabine|"800mg/m2 bid d1-14
~± 1000 mg/m2 bid,days 1-14 q3w: maintenance"
16105903|NCT02119026|Drug|Capecitabine|1000mg/m2 bid d1-14,
16105904|NCT02119026|Drug|Bevacizumab|7,5 mg/kg given on d1 q3w
16105905|NCT02119026|Drug|Oxaliplatin|130mg/m2 iv. d 1 q3w
16105906|NCT02119026|Drug|Irinotecan|200mg/m2 iv. d 1 q3w .
16105907|NCT02119013|Drug|Octeotride|
16105908|NCT02119013|Drug|Placebo|
16105909|NCT02119000|Drug|PEG/electrolytes 2L/2L split dose|Polyethylene glycol 17gm X 4 At 18h00 the day prior the colonoscopy, dilute 2 sachets in 2 L of water and drink 240 mL every 10 minutes On the day of the procedure, 4-5 hours prior the colonoscopy, dilute 2 sachets in 2 L of water and drink 240 mL every 10 minutes
16105910|NCT02119000|Drug|Bisacodyl 15 mg and PEG/electrolytes 1L/1L split dose|"Bisacodyl 15 mg x 3
~At 14h00 the day prior the endoscopic procedure: take 3 tablets of Bisacodyl ER (15 mg) orally then 5 hr later:
~PEG/electrolytes 1L/1L Polyethylene glycol 17gm Dilute one sachet of Polyethylene glycol 17gm in 1 L of water Start drinking at around 19h00 the night prior the colonoscopy Drink 240 ml every 10 minutes The day of the colonoscopy. At (4 hrs prior the procedure). Dilute on sachet of PEG and drink 240 ml every 10 minutes"
16105911|NCT02118987|Drug|Omalizumab|
16105912|NCT02118974|Procedure|Hysterectomy|Hysterectomy
16105913|NCT02118961|Biological|Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DTaP vaccine, BK1301)|0.5 mL, subcutaneous injection
16105914|NCT02118961|Biological|Adsorbed Diphtheria-Tetanus Combined Toxoid (DT toxoid)|0.1 mL, subcutaneous injection
16105915|NCT02118948|Behavioral|Abuse-focused intervention|
16105916|NCT02118948|Behavioral|Sexual behavior-focused intervention|
16105917|NCT02118935|Other|Previously marketed cow's mlik-based infant formula|
16105918|NCT02118935|Other|Marketed cow's milk-based infant formula with prebiotics|
16105919|NCT02118922|Procedure|Brillouin imaging|
16105920|NCT02118909|Drug|Pracinostat|
16105921|NCT02118909|Drug|Itraconazole|
16105922|NCT02118909|Drug|Ciprofloxacin|
16105923|NCT02118896|Drug|FK506E|oral
16105924|NCT02118883|Other|Essentia Water|
16105925|NCT02118883|Other|Bottled water|
16105926|NCT02118870|Drug|Treatment 90 days DAPT|Short term DAPT arm: will continue DAPT with P2Y12 inhibitors and ASA up to 90 days, after which patients will continue.
16105927|NCT02118870|Drug|Treatment 360 days DAPT|Long term (360 days) DAPT arm: will continue DAPT with P2Y12 inhibitors and ASA up to 360 days, after which patients will continue on monotherapy with ASA only, unless contraindications for ASA emerge
16105928|NCT02118857|Other|Omnivore, vegetarian and vegan subjects.|Omnivore, vegetarian and vegan subjects collected the feces, urina and saliva samples for 3 weeks from recruiting.
16105929|NCT02118844|Drug|rocuronium|
16105930|NCT02118831|Biological|Blood Sample Collection|Subjects will have their blood drawn for analysis following their first and third injections of anti-VEGF.
16105931|NCT02118831|Drug|Aflibercept|an intravitreal injection of Aflibercept administered three times on a monthly basis.
16105932|NCT02118831|Drug|Bevacizumab|an intravitreal injection of Bevacizumab administered three times on a monthly basis.
16105933|NCT02118831|Drug|Ranibizumab|an intravitreal injection of Ranibizumab administered three times on a monthly basis.
16105934|NCT02118818|Genetic|Next generation sequencing|There will be no intervention. This is an observational trial to examine the differences in genetic variants and gene expression between patients with and without RHD.
16105935|NCT02118792|Drug|AN2728 Topical Ointment, 2%|
16105936|NCT02118792|Drug|Matching vehicle control|
16105937|NCT02118779|Behavioral|Behavioural change intervention|The intervention is cognitive behaviour therapy (CBT). The CBT consists of six different modules. All patients will start with individual goal setting and psycho-education about the role of cognitive-behavioural variables in the disabilities patients' experience. The patient formulates his or her treatment goals in concrete terms and later on in the therapy the goals are realised step by step by the patient. The treatment is tailored to the patient's problems: which of the six modules a patient will receive is dependent on the scores on measures that have been collected at baseline assessment. Based on our previous experience with modular interventions we expect that most patients will receive less than four modules.
16105938|NCT02118766|Drug|AN2728 Topical Ointment, 2%|
16105939|NCT02118766|Drug|Matching vehicle control|
16105940|NCT02118753|Drug|Eplerenone|eplerenone administered ex vivo (to the organ bath in which human atrial tissue is exposed)
16105941|NCT02118727|Drug|Memantine|All randomized patients will be instructed to take one tablet once a day for the first week from a blinded bottle that contains 10 mg tablets or matching placebo. At week two, patients will be instructed to take one tablet twice a day from the 10 mg bottle or matching placebo. At week three, patients will be instructed to take two tablets in the morning from the 10 mg bottle and one tablet from the 10 mg bottle or the matching placebo bottle in the evening. At week four patients will be instructed to take two pills twice a day from the 10 mg bottle or matching placebo.
16105942|NCT02118727|Drug|Placebo (for Memantine)|All randomized patients will be instructed to take one tablet once a day for the first week from a blinded bottle that contains 10 mg tablets or matching placebo. At week two, patients will be instructed to take one tablet twice a day from the 10 mg bottle or matching placebo. At week three, patients will be instructed to take two tablets in the morning from the 10 mg bottle and one tablet from the 10 mg bottle or the matching placebo bottle in the evening. At week four patients will be instructed to take two pills twice a day from the 10 mg bottle or matching placebo.
16105943|NCT02118714|Drug|Atrasentan|Atrasentan
16105944|NCT02118701|Other|Shared Decision-Making educational training|
16105945|NCT02118688|Drug|Risperidone|
16105946|NCT02118688|Drug|Trazodone|
16105947|NCT02118688|Drug|Placebo|
16105948|NCT02118675|Other|Body Measurements|A series of body measurements will be taken by trained staff. These measurements include height and weight. These measurements will be completed twice during this time. You will wear a hospital gown and bathing suit for these measurements. Your BMI will be calculated from these measurements.
16105949|NCT02118675|Other|Body Composition and Circumference measurements|This test is to measure the amount of water in your body. After a fasting urine sample is collected, you will drink a glass of water that has been enriched with an atom called a stable isotope (deuterium). After you drink this non-radioactive heavy water, you will provide urine samples several times over the next 4 hours.
16105950|NCT02118675|Other|Whole Body DXA scan|This scan measures the amount of bone, muscle, and fat in your body. The scan will be performed using a whole-body scanner. You will be required to wear a hospital gown, to remove all metal-containing objects from your body, and to lie down on the table. You will be carefully positioned on the table, and your legs will be placed together using two Velcro straps. A scanner emitting low energy X-rays and a detector will pass along your body. You will be asked to remain completely still while the scan is in progress. The scan takes approximately ten minutes.
16105951|NCT02118675|Other|Bioelectrical Impedance Analysis (BIA)|These tests will measure the amount of fat in your body. You will be asked to change into a hospital gown and to remove all footwear and socks/stockings. Once changed and barefoot, you will be asked to stand on a scale (similar to a large gym scale) and to hold on to hand electrodes on each side of the scale. You will be asked to step off of the scale once the measurement is complete (less than one minute). You will repeat this procedure on three different BIA systems.
16105952|NCT02118675|Other|BodPod|This test will estimate the amount of fat mass and fat free mass in your body. You will be required to change into a swimsuit and swim cap that we will provide for this procedure. If your swimsuit meets the necessary criteria, you can bring and wear it for the procedure, or PBRC will provide one for you. You will step onto a scale for a quick weight measurement. Next, you will sit inside of the system like you are sitting in a chair. The door of the system will be closed, but you will have a window so that you can see outside of the system while the measurements are completed. The test will be completed in about 15 minutes.
16105953|NCT02118675|Other|Circumferences|This test will measure the circumferences of your waist, hip, neck, arms, and legs and the lengths of your forearm, upper arm, thigh, and lower leg. The circumference measurements will be made by a trained observer using a calibrated tape measure and an automated circumference measurement device (KX-16). These measurements will be made in about 30 minutes.
16105954|NCT02118675|Other|Ultrasound|An ultrasound is a procedure that uses sound waves to create a picture of an organ or soft tissue. This test measures the size of your tissue thicknesses for fat and skeletal muscle. For this procedure, you will be asked to raise your shirt, disrobe from the waist up, or change into a hospital gown and lie flat on your back on an examination table, or sit on a chair, or stand for measuring your leg dimensions. A gel will be spread on the ultrasound probe, and the probe will be applied directly to the skin on your arms, legs, and abdomen. You will feel slight pressure when the probe is applied. The entire procedure will take approximately 30 minutes.
16105955|NCT02118662|Other|Energy Expenditure during seated in an office chair|You will first rest motionless in a chair for 20 minutes. You will complete the working conditions for 15 minutes each at your own self-selected level of effort. A rest period of 5 minutes will be given between each condition. During the working conditions, you will be asked to retype a displayed standard set of text.
16105956|NCT02118662|Other|Energy Expenditure during seated and typing|You will complete this working conditions for 15 minutes. A rest period of 5 minutes will be given between each condition. During the working conditions, you will be asked to retype a displayed standard set of text.
16105957|NCT02118662|Other|Energy Expenditure during Treadmill walking work condition|You will complete the working conditions for 15 minutes each at your own self-selected level of effort. A rest period of 5 minutes will be given between each condition. During the working conditions, you will be asked to retype a displayed standard set of text.
16105958|NCT02118662|Other|Energy Expenditure during cycling work condition|You will complete the working conditions for 15 minutes each at your own self-selected level of effort. A rest period of 5 minutes will be given between each condition. During the working conditions, you will be asked to retype a displayed standard set of text.
16105959|NCT02118649|Behavioral|Game|
16105960|NCT02118623|Behavioral|Moderated discussion board|"All groups will have access to asynchronous, moderated discussion boards. Assignment to discussion board will be stratified by randomization group (Level 1, 2 or 3). Level 1 access to the discussion board will serve as our peer support control condition, although we do expect some modest benefit from this intervention alone.
~The discussion boards will be moderated by research staff, who will be supervised by a trained clinician (masters levels or higher). Discussion boards will be asynchronous, with all posts screened by the moderator(s) before appearing to the group."
16105992|NCT02118376|Drug|Exenatide|5ug bid,Subcutaneous injection
16105993|NCT02118350|Behavioral|Mat Pilates Training|Mat Pilates training performed two times at week for 16 weeks.
16106540|NCT02114502|Drug|Glutamine|15 g four times a day, swished, gargled and spit on Day -9 until discharge.
16105961|NCT02118623|Behavioral|Psychoeducation|"Online psychoeducation is only available to those randomized to Levels 2 and 3. The core modules of MoodSwings 2.0 will use videos and improved organization of content based on feedback from previous pilot work. Module topic areas include:
~What is bipolar disorder? - Content about symptoms and diagnosis
~Stress and triggers of illness
~Medication and the biological basis of bipolar disorder
~Depression - Symptoms, early detection and helpful strategies
~Mania and hypomania - Symptoms, early detection and helpful strategies."
16105962|NCT02118623|Behavioral|Interactive Psychosocial Tools|"Online psychosocial tools are only available to those randomized to Level 3. They include structured mood monitoring, medication monitoring, and life charting visual tools. There are also interactive worksheets that encourage awareness of negative thoughts and strategies to challenge them, help participants weight the costs and benefits of different behaviours, problem solving and goal setting, and reinforcing self-affirmation. Participants have the opportunity to build a record of personal triggers of illness and illness profile - including early warning signs, and symptoms typically experienced during an episode of illness, as well as a personal relapse prevention plan."
16105963|NCT02118610|Drug|L-tetrahydropalmatine (30mg)|Active comparator
16105964|NCT02118610|Drug|Sugar pill|Placebo
16105965|NCT02118597|Drug|Boceprevir|Boceprevir administered according to corresponding summary of product characteristics (SmPC).
16105966|NCT02118597|Drug|Simeprevir|Simeprevir administered according to corresponding summary of product characteristics (SmPC).
16105967|NCT02118597|Drug|Pegylated Interferon (Peginterferon) Alfa-2a|Pegylated interferon (peginterferon) alfa-2a according to corresponding summary of product characteristics (SmPC).
16105968|NCT02118597|Drug|Ribavirin|Ribavirin according to corresponding summary of product characteristics (SmPC).
16105969|NCT02118584|Drug|Etrolizumab|Participants will receive etrolizumab 105 milligrams (mg), administered subcutaneously (SC) every 4 weeks for up to 9 years or until either commercial availability or the Sponsor's decision to terminate the study.
16105970|NCT02118558|Device|Negative Pressure Wound Therapy (NPWT)|
16105971|NCT02118558|Drug|standard prophylactic therapy|administration of antibiotics before the first incision, keeping the surgery field sterile and performing several rinsing
16105972|NCT02118532|Device|IN.PACT Admiral Paclitaxel-Eluting Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter|IN.PACT Admiral Paclitaxel-Eluting Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter originally developed, approved and commercialized by Invatec Technology Center GmbH is the investigational medical device used in the study. Medtronic Inc. acquired Invatec on April 21, 2010. Medtronic
16105973|NCT02118519|Biological|Autologous Mesenchymal Stem Cells|Comparison of clinical outcomes of patients injected by mesenchymal stem cells only with patients injected with mesenchymal stem cells supported by platelet lysate
16105974|NCT02118506|Other|Physical practice|"The control group underwent familiarization of gait phases using cards with gait phases and physical gait training.
~Familiarization with gait cycle: Cards with pictures of an elderly person performing movements related to the adjustment of posture, gait initiation and gait phases were shown to the subjects. They should have organized them sequentially, showing that they learned gait phases. Then, they were submitted to a physical gait training. They underwent a single training session during 1 hour and 30 minutes and were reassessed 10 minutes and 1 day after the end of the session, in respect of the kinematic gait and mobility."
16105975|NCT02118506|Other|Mental and physical practice|"The experimental group underwent familiarization of gait phases using cards with gait phases, mental practice of gait and physical gait training.
~Familiarization with gait cycle: Cards with pictures of an elderly person performing movements related to the adjustment of posture, gait initiation and gait phases were shown to the subjects. They should have organized them sequentially, showing that they learned gait phases.
~Then, they were submitted to a mental training of gait. They imagined the gait steps per 400 repetitions. While imagining, they verbalized the gait phases.
~Finally, they were submitted to a physical gait training. They executed 400 steps.
~They underwent a single training session during 1 hour and 30 minutes and were reassessed 10 minutes and 1 day after the end of the session, in respect of the kinematic gait and mobility."
16105976|NCT02118493|Device|Benign Biliary Stenosis, Laser|Single use of laser to attempt excision of biliary ductal tissue causing stenosis.
16105977|NCT02118480|Other|cognitive remediation program: REHACOP|Specifically, REHACOP group remediation with PD patients consisted of: Attention unit (4 weeks) training sustained, selective, alternant and divided attention; Memory unit (3 weeks) focusing on visual and verbal learning, recall and recognizing memory; Language unit (3 weeks) including grammar, syntax, vocabulary, verbal fluency, verbal comprehension, abstract language; Executive functions unit (2 weeks) training cognitive planning, proverbs, analogies; and Social cognition unit (1 week) exercising theory of mind, social reasoning and moral dilemmas.
16105978|NCT02118480|Other|Occupational Therapy|The activities included drawing, reading the daily news and constructing using different materials (such as paper or wood). These activities were accomplished in a group format and with the same frequency as the implementation of REHACOP in the experimental group.
16105979|NCT02118467|Drug|Norepinephrine|Dose range 0.03 to 0.3 mcg/kg/minute, titrated to target blood pressure.
16105980|NCT02118467|Drug|Epinephrine|Dose range 0.03 to 0.3 mcg/kg/minute, titrated to target blood pressure.
16105981|NCT02118467|Drug|Phenylephrine|Dose range 0.3 to 3.0 mcg/kg/minute, titrated to target blood pressure.
16105982|NCT02118467|Drug|Vasopressin|Dose range 0.1 to 0.6 milliunits/kg/minute, titrated to target blood pressure.
16105983|NCT02118454|Behavioral|Daily IVR Calls Intervention|
16105984|NCT02118454|Behavioral|Weekly IVR Survey Only|
16105985|NCT02118441|Device|Ultrasound-guided Radial Artery Catheter Insertion|
16105986|NCT02118441|Device|Direct Palpation-guided Radial Artery Catheter insertion|
16105987|NCT02118428|Device|Mirasol-treated Whole Blood|Transfusion with fresh Whole Blood treated with the Mirasol Pathogen Reduction Technology System for Whole Blood
16105988|NCT02118428|Biological|Untreated Whole Blood|Transfusion with untreated fresh Whole Blood
16105989|NCT02118415|Other|Hsp70-peptide TKD/IL-2 activated, autologous NK cells|Adjuvant treatment with Hsp70-peptide TKD/IL-2 activated, autologous NK cells following completion of standard radiochemotherapy (Cisplatin/Vinorelbine)
16105990|NCT02118402|Dietary Supplement|Fortified maize porridge|Maize porridge will be home-fortified with either A) MNP, B) MNP+Fe, C) MNP+Fe+GOS
16105991|NCT02118389|Dietary Supplement|Glucerna|Glucerna 52g meal replacement
16105994|NCT02118337|Biological|MEDI0680|Participants will receive IV infusion of MEDI0680 0.1 or 0.5 or 2.5 or 10 or 20 mg/kg Q2W in dose-escalation phase and 20 mg/kg Q2W in dose-expansion phase.
16105995|NCT02118337|Biological|Durvalumab|Participants will receive IV infusion of durvalumab 3 and 10 mg Q2W in dose-escalation phase and 750 mg Q2W in dose-expansion phase.
16105996|NCT02118337|Biological|Nivolumab|Participants will receive IV infusion of nivolumab 240 mg Q2W in dose-expansion phase.
16105997|NCT02118324|Behavioral|Exergaming Program|Participants will exercise through exergaming play.
16105998|NCT02118311|Biological|T Regulatory cells|Fixed dose of nTreg cells will be infused on day 0 of transplant after the umbilical cord blood cells
16105999|NCT02118311|Drug|Fludarabine|Fludarabine 30mg/m^2 IV over 1 hour on days -6 through -2 from transplant
16106000|NCT02118311|Drug|Cyclophosphamide|Cyclophosphamide 50 mg/kg IV over 2 hours on day -6 from transplant
16106001|NCT02118311|Radiation|Total Body Irradiation|Total Body Irradiation (TBI) 200 cGy administered on day -1 in a single fraction will be given at a dose rate of 10-19 cGy/minute prescribed to the midplane of the patient at the level of the umbilicus.
16106002|NCT02118285|Drug|Fludarabine|Fludarabine 25 mg/m^2 IV on days -6 through -2 from NK cell infusion
16106003|NCT02118285|Drug|Cyclophosphamide|Cyclophosphamide 30 mg/kg IV on days -5 and -4 from NK cell infusion
16106004|NCT02118285|Biological|NK cells|CD3-/CD19- selected NK cells administered by intraperitoneal (IP) infusion on day 0
16106005|NCT02118285|Biological|IL-2|IL-2 at 6 million units/dose IP 3 times a week x 6 doses with the 1st dose given immediately after the NK cell infusion
16106006|NCT02118285|Drug|INCB024360|INCB024360 at assigned dose by mouth twice a day begin day -2 and continue for 90 days (+/- 3 days)
16106007|NCT02118272|Device|Physica KR|
16106008|NCT02118259|Other|Before-after study|"The before-after study is composed of a first observational phase followed by a proactive phase, and then finally by a second observational phase.
~The first observational phase corresponds to retrospective data-collecting for the information necessary for calculating the baseline ADE geriatric risk score.
~The proactive phase corresponds to a multidisciplinary review of drug prescriptions (especially long-term drugs) for all included patients in the residence.
~During the second observational phase, the same data as in the first observational phase will be collected a second time."
16106009|NCT02118246|Device|Dry Needling|Dry needling was performed for one week, three times a week.
16106010|NCT02118246|Device|Kinesio Tape|Kinesio tape was performed for one week, three times a week.
16106011|NCT02118220|Other|Concussion Questionnaire|
16106012|NCT02118207|Other|Aerobic running exercise|60 min of aerobic intervals completed prior to SCUBA diving
16106013|NCT02118181|Dietary Supplement|HMB|
16106014|NCT02118168|Other|No intervention|No intervention is foreseen in this Observational Study
16106015|NCT02118155|Procedure|Connective tissue graft|Periodontal surgical technique to treat gingival recessions
16106016|NCT02118142|Dietary Supplement|Betaine|6 gram one-time dose of betaine delivered in encapsulated form with an unsweetened beverage
16106017|NCT02118142|Dietary Supplement|Dextrose|6 gram one-time dose of dextrose delivered in encapsulated form with an unsweetened beverage
16106018|NCT02118129|Behavioral|an educational video|
16106019|NCT02118129|Other|wait listed|
16106020|NCT02118116|Other|Applied Suicide Intervention Skills Training|Applied Suicide Intervention Skills Training is a 2-day, 14-hour intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide. The ASIST program has five learning sections: 1) Preparing - Sets the tone, norms, and expectations of the workshop; 2) Connecting - allows participants to explore their own attitudes towards suicide and creates an understanding of the impact that attitudes have on the intervention process. 3) Understanding - Describes the intervention needs of a person at risk. 4) Assisting - Presents a model for suicide intervention. 5) Networking - Generates information about resources in the local community.
16106021|NCT02118103|Procedure|Spinal Manipulation|Lumbar spinal manipulation
16106022|NCT02118090|Drug|Chloroquine sulfate|Chloroquine sulfate (NIVAQUINE) - 30 mg/kg for 3 days
16106023|NCT02118090|Drug|DHA-PP|DHA-PIP (Duo-Cotecxin®, DHA 40 mg and PP 320 mg, Zhejiang Holley Nanhu Pharamaceutical Co. Ltd, Jiaxing, Zhejiang province, China): one tablet of DHA-PIP contains 40 mg of dihydroartemisinin (DHA) and 320 mg piperaquine (PIP). It is an oral administration, one dose a day for 3 consecutive days. An adult dose (≥40 kg to 60kg body weight or more than 15 years old) consisted of three doses of 3 tablets over consecutive days (Total dose 9 tablets). The approximate total adult dose was 2-4 mg/kg for DHA and 20mg/kg for PP.
16106024|NCT02118077|Biological|G17DT|
16106025|NCT02118064|Biological|G17DT-Irinotecan|500µg dose of G17DT intramuscular injection in combination with 125 mg/m^2 intravenous infusion of Irinotecan over 90 minutes.
16106026|NCT02118051|Drug|Ganirelix 0.25 mg.|Ganirelix 0.25 mg. Route of administration: Subcutaneous use. Dose: 250μg/24h since the day observe a follicle> 14mm.
16106027|NCT02118051|Drug|Recombinant choriogonadotropin alfa|Recombinant choriogonadotropin alfa. Route of administration: Subcutaneous use. Dose: 6,500 IU, pods, when follicles> 17 mm are observed
16106028|NCT02118051|Drug|Micronized natural progesterone.|Micronized natural progesterone. Route of administration: vaginal . Dose: 400mg/24, from embryo transfer until the day of b-hCG.
16106029|NCT02118025|Procedure|Off-pump coronary artery bypass graft|Patients operated with the heart beating, without heart arrest.
16106030|NCT02118025|Procedure|Mini extracorporeal circulation bypass|Patients operated with a modified extracorporeal circulation system
16106031|NCT02118012|Drug|Chlorcyclizine HCl|Chlorcyclizine HCl (75 mg twice daily)
16106032|NCT02118012|Drug|Ribavirin|RBV was dosed via a weight-based regimen of 1000 mg daily<75 kg and 1200 mg daily ≥75 kg.
16106033|NCT02117999|Device|Cross-linking with iontophoresis|The procedure involves a constant current source and two electrodes. The active electrode is a bath tube, which includes a stainless steel grid, placed into the cup at a minimal distance from the cornea. The reservoir is filled with dextran-free, hypotonic riboflavin-5-phosphate solution. The generator applies a constant current of 1mA for a preset period of 5 min. After the riboflavin administration by iontophoresis, the cornea is irradiated using a UVA lamp of 10mW/cm2 for 9 minutes.
16106078|NCT02117700|Dietary Supplement|N-acetyl cysteine 600mg twice/day|N-acetyl cysteine 600 mg twice/day for 16 weeks
16106034|NCT02117999|Device|Standard corneal cross-linking|In the standard CL, the epithelium is mechanically removed. Then, a solution of riboflavin is instilled each minute for 30 minutes. Corneas are irradiated using a UVA lamp of 3mW/cm2 for 30 minutes.
16106035|NCT02117986|Drug|colistin|One arm will receive a loading dose of colistin (6 million international units), and a maintenance dose of 3 million every 8 hours. The other arm will receive a maintenance dose of 3 million international units every 8 hours.
16106036|NCT02117973|Procedure|iAssist Technique using Persona system vs. the conventional technique using Persona system|
16106037|NCT02117960|Dietary Supplement|Omega-3|4 cap 1 g Omega-3 per day for 2 months
16106038|NCT02117960|Dietary Supplement|Placebo|4 cap 1 g Placebo(paraffin) per day for 2 months
16106039|NCT02117947|Behavioral|Behavioral Counseling|Behavioral counseling used components of evidence-based smoking intervention treatment to promote maternal smokers efforts in reducing their children's exposure to secondhand smoke.
16106040|NCT02117947|Behavioral|Self-help control|This intervention group received a comprehensive self-help manual that included information and advice about how to protect children from secondhand smoke (e.g., adopting a smokefree home and car.)
16106041|NCT02117934|Biological|HEPLISAV|Intramuscular injections at Week 0 and Week 4, plus a placebo injection at Week 24
16106042|NCT02117934|Biological|Engerix-B|Intramuscular injections at Week 0, Week 4, and Week 24
16106043|NCT02117921|Behavioral|One-on-one interview and educational sessions. Reading material for educational series provided.|A one-on-one interview with the patient and the principal investigator and group educational sessions.
16106044|NCT02117908|Device|RESMED AUTOSET S9|Continuous positive pressure during surgery
16106045|NCT02117895|Procedure|Celiac plexus resection|Celiac plexus at the left side of aorta, between celiac trunk and superior mesenteric artery will be resected.
16106046|NCT02117895|Procedure|Pancreatectomy|Standard distal pancreatectomy includes distal pancreatectomy, splenectomy, and regional lymph nodes resection for pancreatic cancer at the body and tail. Regional lymph nodes includes group 8, 10, 11, 18, 7, 9, 14, 15, according to the 2003 edition of lymph nodes group system defined by Japan Pancreas Society (JPS).
16106047|NCT02117869|Other|Low furanocoumarin hybrid grapefruit juice|3 consecutive daily doses of 200ml low furanocoumarin grapefruit juice plus midazolam 5mg orally on the third day.
16106048|NCT02117869|Other|Regular grapefruit juice|3 consecutive daily doses of 200ml regular grapefruit juice plus midazolam 5mg orally on the third day.
16106049|NCT02117869|Other|Water (control)|3 consecutive daily doses of 200ml water plus midazolam 5mg orally on the third day.
16106050|NCT02117856|Procedure|1 implant placed surgically in the mandibular midline|Participants receive an implant in the mandibular midline using a surgical flap procedure with local anaesthesia.
16106051|NCT02117856|Procedure|2 implants placed surgically in the mandibular canine sites|Participants receive implants bilaterally in the site of the mandibular canines using a surgical flap procedure with local anaesthesia.
16106052|NCT02117856|Procedure|Soft reline (Coe Comfort) of the existing complete lower denture|Participants receive a soft reline of the existing complete lower denture approximately 10 days after placement of the implant(s).
16106053|NCT02117856|Device|2.25mm ball patrix placed on 1 healed implant|A 2.25mm ball patrix is screwed onto the 1 implant approximately six weeks after placement of the implant.
16106054|NCT02117856|Device|2.25mm ball patrices placed on 2 healed implants|2.25mm ball patrices are screwed onto the 2 implants approximately six weeks after placement of the implants.
16106055|NCT02117856|Procedure|Reline (Ivoclar acrylic-resin) with 1 retentive matrix in the lower denture|Participants have their complete lower denture relined with a laboratory-processed acrylic resin to incorporate 1 retentive matrix in the denture-base to retain on the implant.
16106056|NCT02117856|Procedure|Reline (Ivoclar acrylic-resin) with 2 retentive matrices in the lower denture|Participants have their complete lower denture relined with a laboratory-processed acrylic resin to incorporate 2 retentive matrices in the denture-base to retain on the implants
16106057|NCT02117843|Device|AVI® Arsenic trioxide drug eluting stent|AVI® Arsenic trioxide drug eluting stent
16106058|NCT02117830|Drug|Androxal 25 mg capsules|
16106059|NCT02117830|Drug|Androxal 250 Capsules|
16106060|NCT02117830|Drug|Placebo Capsules|
16106061|NCT02117830|Drug|Moxifloxacin 400 mg|
16106062|NCT02117817|Drug|BKM120|
16106063|NCT02117817|Drug|Nabpaclitaxel|Given IV
16106064|NCT02117804|Other|Early Screen for Discharge Planning|This screen is completed by a study coordinator within 24 hours of patient admission to the hospital. The screen measures four variables available from routine hospital admission clinical data (walking limitation, age, living alone prior to admission, and level of disability) that exhibit high sensitivity and specificity (AUC's were .82 and.84) in identifying patients who should receive targeted attention from a DP expert.
16106065|NCT02117791|Drug|Riociguat (ADEMPAS, BAY63-2521)|The treatment of Riociguat should comply with the local product information (start dose: 3 mg/day, maximum dose: 7.5 mg/day)
16106066|NCT02117778|Procedure|Continuous Nerve Block|
16106067|NCT02117765|Drug|Ustekinumab|
16106068|NCT02117752|Drug|dapsone gel|Patches containing dapsone gel will be applied to the skin.
16106069|NCT02117752|Drug|dapsone gel vehicle|Patches containing dapsone gel vehicle will be applied to the skin.
16106070|NCT02117752|Drug|sodium lauryl sulfate|Patches containing sodium lauryl sulfate (Positive Control) will be applied to the skin.
16106071|NCT02117752|Drug|Normal saline|Patches containing normal saline (Negative Control) will be applied to the skin.
16106072|NCT02117739|Drug|dapsone gel|Patches containing dapsone gel will be applied to the skin.
16106073|NCT02117739|Drug|dapsone gel vehicle|Patches containing dapsone gel vehicle will be applied to the skin.
16106074|NCT02117726|Drug|Dexmedetomidine,midazolam|
16106075|NCT02117726|Drug|Propofol,midazolam|
16106076|NCT02117713|Drug|LUM001 (Maralixibat)|Dosing of LUM001 also known as Maralixibat (MRX) with the objective of achieving optimal control of pruritus at a dose level that is tolerated by the participant and up to a maximum daily dose of 280 micrograms per kilogram (mcg/kg).
16106077|NCT02117700|Dietary Supplement|N-acetyl cysteine 600 mg once/day|NAC 600 mg once/day + Placebo once/day for 16 weeks
16106079|NCT02117700|Other|Placebo twice/day|Placebo capsules twice/day for 16 weeks
16106080|NCT02117687|Drug|carboxymethylcellulose 0.5%/glycerin 0.9%|1-2 drops OPTIVE FUSION™ (carboxymethylcellulose 0.5%/glycerin 0.9%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
16106081|NCT02117687|Drug|sodium hyaluronate 0.18%|1-2 drops VISMED® Multi (sodium hyaluronate 0.18%) in each eye as needed at least 2 times and no more than 6 times daily, for 3 months.
16106082|NCT02117674|Procedure|standard forward-viewing colonoscopy|examination of the colon with a conventional colonoscope
16106083|NCT02117674|Procedure|full-spectrum colonoscopy|examination of the colon with full-spectrum colonoscope
16106084|NCT02117674|Procedure|right colon retroflexion|examination of the right colon with scope retroflexion (both with conventional and fuse scope)
16106085|NCT02117661|Dietary Supplement|L-carnitine capsules|Oral
16106086|NCT02117661|Dietary Supplement|Cellulose capsules|oral
16106087|NCT02117648|Drug|Abemaciclib|Administered orally
16106088|NCT02117648|Drug|Clarithromycin|Administered orally
16106089|NCT02117635|Biological|CTX DP|20 million cell dose administered by surgery to the damaged area of the brain
16106090|NCT02117622|Drug|insulin degludec|Treatment according to routine clinical practice at the discretion of the treating physician. The assignment of the patient to Tresiba® is decided in advance of this study
16106091|NCT02117609|Dietary Supplement|New DELICAL formula|3 months with the option of continuing until 6 months.
16106092|NCT02117609|Dietary Supplement|Standard DELICAL formula|3 months with the option of continuing until 6 months.
16106093|NCT02117596|Drug|Sirolimus|"Tacrolimus (Prograf®) At 6 months post-transplantation, patients will have Prograf® tapered by 25% per week such that they will be off of this medication by 7 months post-transplantation.
~Sirolimus (Rapamune®):
~At 6 months post-transplantation, all patients will be administered Sirolimus at a dose of 1.65-2.79 mg/m2/day as a tablet or liquid (administered q 12 hours)."
16106094|NCT02117583|Drug|Oxycodone|One capsule of 40 mg PF-00345439 Formulation K, taken whole, single dose, under fasting conditions
16106095|NCT02117583|Drug|Oxycodone|One capsule of 40 mg PF-00345439 Formulation K, taken whole, single dose, under fed conditions
16106096|NCT02117583|Drug|Oxycodone|One capsule of 40 mg PF-00345439 Formulation K, Chewed, single dose, under fasting conditions
16106097|NCT02117583|Drug|Oxycodone|One capsule of 40 mg PF-00345439 Formulation K, Chewed, single dose, under fed conditions
16106098|NCT02117570|Biological|Clostridium difficile vaccine|0.5 mL intramuscular injection on day 1, day 8, and day 30.
16106099|NCT02117570|Biological|Clostridium difficile vaccine|0.5 mL intramuscular injection on day 1, day 8, and day 30.
16106100|NCT02117570|Biological|Placebo|Placebo (0.9 percent saline) given as a 0.5 mL intramuscular injection on day 1, day 8, and day 30.
16106101|NCT02117557|Procedure|Single incision laparoscopic surgery|
16106102|NCT02117557|Procedure|Conventional laparoscopic surgery|
16106103|NCT02117544|Device|Lotrafilcon B multifocal contact lenses (new)|
16106104|NCT02117544|Device|Lotrafilcon B multifocal contact lenses|
16106105|NCT02117518|Other|blood drawing|
16106106|NCT02117505|Drug|Formulation 2|Single-dose of JNJ-54781532 formulation 2 will be administered as 150 milligram (mg) oral tablet in one of the treatment periods.
16106107|NCT02117505|Drug|Formulation 1|Single-dose of JNJ-54781532 formulation 1 will be administered as 150 milligram (mg) oral tablet (5*30 mg tablet=150 mg) in one of the treatment periods.
16106108|NCT02117492|Procedure|Cuff Closure|Closure of the vaginal cuff following hysterectomy.
16106109|NCT02117479|Drug|Ruxolitinib|5 mg tablets to be administered by mouth twice daily (BID)
16106110|NCT02117479|Drug|Placebo|5 mg tablets to be administered by mouth twice daily (BID)
16106111|NCT02117479|Drug|Capecitabine|150 and 500 mg tablets to be administered by mouth twice daily (BID)
16106112|NCT02117466|Drug|Dose escalation cetuximab|dose escalation of cetuximab (described in the second arm)
16106113|NCT02117466|Drug|Standard dose cetuximab|500mg/m2 bsa cetuximab (described in the first arm)
16106114|NCT02117453|Drug|Rosuvastatin|Rosuvastatin 20 mg/day
16106115|NCT02117453|Drug|Placebo|Placebo
16106116|NCT02117427|Biological|MDGN201 TARGTEPO|Erythropoietin secreted by TARGTEPO transduced with MDGN201
16106117|NCT02117414|Device|MRI scan sequences of the head and chest regions|Non-diagnostic MRI scans
16106118|NCT02117414|Other|Waiting Period Visit|Waiting period time will equate to 1 hour
16106119|NCT02117401|Drug|mivacurium chloride|intravenously injected during induction with the dose according to allocated group, and intravenously injected with the dose of 0.1 mg/kg when T1 recovers to 25% during period of maintenance.
16106120|NCT02117401|Drug|midazolam|"Before induction: after moving into operating room, oral administration with dose of 0.5 mg/kg or mixed with ketamine (midazolam 10 mg+ ketamine 100 mg) with dose of 0.1 ml/kg by intramuscular route for uncooperative children
~Induction: for children who didn't receive mixture of midazolam and ketamine before induction, it will be given with the dose of 0.05 ml/kg"
16106121|NCT02117401|Drug|ketamine|"mixed with ketamine (midazolam 10 mg+ ketamine 100 mg) with dose of 0.1 ml/kg by intramuscular route for uncooperative children
~Induction: for children who didn't receive mixture of midazolam and ketamine before induction, it will be given with the dose of 0.05 ml/kg"
16106122|NCT02117401|Drug|propofol|Induction: 2 to 3 mg/kg Maintenance: 50 to 100 mcg/kg/min
16106123|NCT02117401|Drug|Remifentanil|Induction: 2 mcg/kg Maintenance: 0.1 to 0.3 mcg/kg/min
16106124|NCT02117388|Behavioral|Sleep Restriction|Sleep Restriction therapy will limit the time spent in bed in order to make sure participants are sleepy enough to fall asleep quickly.
16106125|NCT02117388|Behavioral|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy is designed to identify incorrect ideas about sleep, challenge their validity, and replace them with correct information. This therapy tries to reduce worry, anxiety, and fear that one won't sleep by providing accurate information about sleep.
16106126|NCT02117388|Behavioral|Combined Therapy|Sleep Restriction and Cognitive Therapy will be combined so that the two therapies reinforce each other.
16106127|NCT02117375|Device|spinal cord MRI follow-up|Evaluation : focal lesions (number, volume, localisation), atrophy, parameters from Diffusion Tensor Imaging and parameters from Magnetization Transfer Ratio
16106170|NCT02117115|Radiation|Dynamic contrast-enhanced computed tomography|CT scan performed between Day +7 and Day +14.
16106128|NCT02117375|Other|clinical follow-up|Relapses, treatments, global disability,walking performance, upper limbs motor performance, sphincter disturbances and walking difficulty
16106129|NCT02117375|Other|brain MRI follow-up|
16106130|NCT02117362|Biological|1 mg/kg GR-MD-02|1 mg/kg GR-MD-02 on Days 1, 22, 43, and 65.
16106131|NCT02117362|Biological|2 mg/kg GR-MD-02|2 mg/kg GR-MD-02 on Days 1, 22, 43, and 65.
16106132|NCT02117362|Biological|4 mg/kg GR-MD-02|4 mg/kg GR-MD-02 on Days 1, 22, 43, and 65
16106133|NCT02117362|Biological|8 mg/kg GR-MD-02|8 mg/mg GR-MD-02
16106134|NCT02117362|Biological|Ipilimumab|3 mg/kg ipilimumab on Days 1, 22, 43, and 65
16106135|NCT02117349|Drug|Raplixa|Raplixa is a biological product approved for use in adults to help control bleeding from small blood vessels when standard surgical techniques, such as suture, ligature or cautery, are ineffective or impractical. When applied to a bleeding site, Raplixa is dissolved in the blood and a reaction starts between the fibrinogen and thrombin proteins. This results in the formation of blood clots to help stop the bleeding.
16106136|NCT02117349|Device|Gelfoam|Gelfoam Sterile Sponge is a medical device (USP, Pfizer) intended for application to bleeding surfaces as a hemostatic. It is a water-insoluble, off-white, nonelastic, porous, pliable product. It may be cut without fraying, used wet or dry, and is able to absorb many times its weight in blood and other fluids.
16106137|NCT02117349|Drug|Rescue treatment|Thrombin-containing hemostats included in standard care at the site
16106138|NCT02117336|Drug|P1446A-05|"The study have dose escalation phase, followed by a dose extension phase.
~Dose escalation phase: five Dose Levels will be evaluated in the 'dose escalation' phase. The Dose Levels selected are 50 mg (Dose Level 1), 75 mg (Dose Level 2), 125 mg (Dose Level 3), 200 mg (Dose Level 4) and 275 mg (Dose Level 5), once daily. If required, a 25 mg once daily dose (Dose Level -1) will also be studied. For Dose Levels 1, 2 and 3 there will be 2- dosing periods: Single Dose and Continuous Dose. At least 3-patients will be enrolled at each Dose Level. Dosing regimens planned for Dose Level 4 and 5 are 200 and 275 mg once daily. In the continuous dose period, patients will receive P1446A-05 on a 28-day cycle, until the occurrence of disease progression or unacceptable toxicity.
~Dose Extension Phase: Up to a total of 14 patients will be treated at the MTD of P1446A-05, determined in the dose escalation phase, until the occurrence of disease progression or unacceptable toxicity or death."
16106139|NCT02117310|Drug|indocyanine green|ICG will be administered to identify the blood supply at two distinct stages of endonasal cranial base surgery: during nasoseptal flap harvest and after final positioning of the nasoseptal flap to ensure its viability before ending the case.
16106140|NCT02117297|Drug|Gemtuzumab Ozogamicin|Gemtuzumab, 9.0 mg/m2, will be given IV over 2 hours two times post allogeneic transplantation.
16106141|NCT02117271|Device|continuous positive airway pressure|device to treat obstructive sleep apnea using positive airway pressure with a nasal mask
16106142|NCT02117271|Other|Breathe Right ®|Nasal dilator strip treatment used during sleep to open the nasal airway
16106143|NCT02117258|Drug|Z-360|Gemcitabine (1,000 mg/m^2) will be given by 30-minute intravenous infusion on Day 1, 8, and 15 followed by a one week rest in all 28-day Cycles, while Z-360 (60, 120 or 240 mg) will be taken orally, twice daily (BID) after a meal. Dosing will continue until the patient fulfills the withdrawal criteria.
16106144|NCT02117258|Drug|Placebo|Gemcitabine (1,000 mg/m^2) will be given by 30-minute intravenous infusion on Day 1, 8, and 15 followed by a one week rest in all 28-day Cycles, while placebo will be taken orally, twice daily (BID) after a meal. Dosing will continue until the patient fulfills the withdrawal criteria.
16106145|NCT02117232|Device|Visualization balloon|"The Visualization Balloon is a disposable medical device that is used during the advancement of the colonoscope inside the colon. The intended use of the Visualization Balloon is to help insertion of the colonoscope into the colon without the aid of gas (air or CO2) insufflation as with standard colonoscopy. The Visualization Balloon is inserted through the biopsy channel of the colonoscope prior to the colonoscope introduction into the rectum. The Visualization Balloon is an inflatable balloon that opens up the lumen of the gastrointestinal tract, thereby allowing the endoscopist to advance the endoscope inside and to view the gastrointestinal tract through the clear balloon."
16106146|NCT02117232|Device|Traditional CO2 insufflation colonoscopy|"Traditional colonoscopy performed with CO2 insufflation without Visualization balloon"
16106147|NCT02117219|Biological|MEDI4736 Evaluate MEDI4736 in MDS|MEDI4736 will be administered by IV infusion
16106148|NCT02117219|Drug|VIDAZA|VIDAZA will be administered subcutaneously as described on the package insert VIDAZA will be administered in combination with MEDI4736 upon progression from MEDI4736 monotherapy
16106149|NCT02117219|Biological|tremelimumab|tremelimumab will be administered by IV infusion
16106150|NCT02117206|Drug|L-arginine (L-arginine Veyron)|
16106151|NCT02117206|Drug|Nacl|
16106152|NCT02117193|Other|Alcohol intake|The subjects will be drink beer (with or without alcohol) before sleep intervention (normal sleep and sleep deprivation).
16106153|NCT02117193|Other|Sleep deprivation|One night of sleep deprivation or one night of normal sleep.
16106154|NCT02117180|Other|FODMAP's diet|The safety and efficacy of a low FODMAP diet will be evaluated in a convenience sample of children with functional gastrointestinal disorders, over a 6 week intervention period.
16106155|NCT02117167|Drug|AZD2014|Target: m-TOR
16106156|NCT02117167|Drug|AZD4547|Target: FGFR
16106157|NCT02117167|Drug|AZD5363|Target: AKT
16106158|NCT02117167|Drug|AZD8931|Target: HER2, EGFR
16106159|NCT02117167|Drug|Selumetinib|Target: MEK
16106160|NCT02117167|Drug|Vandetanib|Target : VEGF, EGFR
16106161|NCT02117167|Drug|Standard maintenance for squamous NSCLC|
16106162|NCT02117167|Drug|Pemetrexed|Standard maintenance for non squamous NSCLC
16106163|NCT02117167|Drug|Durvalumab|Target: PD-L1
16106164|NCT02117167|Drug|savolitinib|target : MET
16106165|NCT02117167|Drug|Olaparib|target : PARP
16106166|NCT02117154|Device|6-day Continuous Glucose Monitoring System|performed 3 times on a patient, one month apart
16106167|NCT02117141|Drug|HC-ER 20 mg capsule (fasted)|Single oral dose HC-ER 20 mg capsule after overnight fast (fasted)
16106168|NCT02117141|Drug|HC-ER 20 mg capsule (fed)|Single oral dose HC-ER 20 mg capsule after high fat meal (fed)
16106169|NCT02117128|Drug|Tranexamic acid|
16106257|NCT02116530|Drug|Chemotherapy (cisplatin or cyclophosphamide and doxorubicin)|oral or IV
16106171|NCT02117115|Drug|Ioversol|To optimize visualization of bowel mucosal, patient will be given 1350 ml, or as much as can be tolerated, of negative oral contrast to distend the small bowel one hour prior to scanning. A weight-based volume of Optiray-350 will be injected at a rate of 4 cc/sec followed by 50 cc of saline flush also at 4 cc/sec.
16106172|NCT02117102|Other|Bladder and lumbar stimulation technic|
16106173|NCT02117089|Device|Electrical Stimulation; Rehabilitation Robot|The recruited subjects will receive 20-session device assisted upper limb training with an intensity of 3 to 5 sessions/week, which will be finished within 7 consecutive weeks. In each session, the subjects will conduct the system assisted and task-oriented upper limb training for 1.5 hours.
16106174|NCT02117076|Drug|Gabapentin immediate release|up to 1200 mg per day
16106175|NCT02117076|Drug|Gabapentin enacarbil extended release|up to 1200 mg per day
16106176|NCT02117063|Behavioral|Go Girls! Fitness Support Group|Go Girls! is a dance-based patient fitness support group offered by the University of Virginia Pediatric Endocrinology division in conjunction with the Center for Research in Reproduction and the Children's Fitness Clinic at the University of Virginia for girls. The goals of the program are to introduce girls to exercise in a fun, non-threatening environment, meet other girls, enable girls to discover and develop a personal enjoyment of exercise, and enable low-pressure interactions with medical care providers.
16106177|NCT02117050|Drug|Rebif®|Rebif® will be administered subcutaneously three times a week at a dose of 8.8 to 44 microgram (mcg) in initial titration schedule (5 weeks), followed by Rebif® 44 mcg subcutaneously three times a week by using Rebif® Rebidose® auto-injector device till Week 24.
16106178|NCT02117037|Other|blood sample|
16106179|NCT02117024|Drug|Viagenpumatucel-L|Vaccine derived from irradiated human lung cancer cells genetically engineered to continually secrete gp96-Ig
16106180|NCT02117024|Drug|Metronomic Cyclophosphamide|One 50mg tablet administered orally daily for 7 days on alternating weeks for a total of 6 weeks of therapy over 12 weeks
16106181|NCT02117024|Drug|Physician's Choice Regimen (Vinorelbine, Erlotinib, Gemcitabine, Paclitaxel, Docetaxel, Pemetrexed)|"Physician will select one of the following to be given in nominal 21 day cycles with dose and route according to investigator's standard practice:
~Vinorelbine
~Erlotinib
~Gemcitabine
~Paclitaxel
~Docetaxel
~Pemetrexed"
16106182|NCT02117011|Other|Physical Activity|Those participants randomized to the exercise group will be required to exercise 5 days/week for 8 weeks coinciding with the radiation treatment sessions. The exercise intervention will consist of aerobic training. Participants will be required to meet and maintain a goal of 75 min/week of aerobic exercise by using portable cycle ergometers; that is; 15 min/day for 5 days/week. The cycle ergometer consists of two cycling pedals mounted to a stationary block that allows patients to exercise while sitting. The tension on the pedals can be adjusted to provide desired tension. Patients can also move the equipment so they can use it conveniently while sitting anywhere and with any chair.
16106183|NCT02116998|Biological|GEN-004 with Aluminum Hydroxide Adjuvant|"GEN-004: 100 µg of each antigen, with adjuvant, 350 µg aluminum hydroxide, administered as a 0.5 mL intramuscular (IM) injection.
~GEN-004 is a recombinant S. pneumoniae protein subunit vaccine consisting of 3 recombinant T cell antigens:
~GB104: ABC transporter, substrate-binding protein
~GB144: Maltose/maltodextrin binding protein, ABC transporter
~GB152: Hypothetical protein
~GEN-004 is filled in 2 mL vials containing 0.5 mL (350 µg/mL of each antigen).
~Aluminum hydroxide adjuvant is filled in 2 mL vials containing 1 mL at a concentration of 5 mg/mL."
16106184|NCT02116998|Biological|Placebo|Placebo: normal saline, 0.5 mL per dose, IM.
16106185|NCT02116998|Biological|Streptococcus pneumoniae inoculation|Intranasal inoculation of S. Pneumoniae (80,000 CFU/100μl per nostril) serotype 6B.
16106186|NCT02116985|Device|Dual-loop TCI|the controller in the current study measures and calculates the error(NI error),which is the difference between the set point(NI=36)and the measured NI.If the NI error is different from 0,the controller determines a new propoflo and/or remifentanil concentration.
16106187|NCT02116985|Device|manual|the investigator modified the effect-site target concentrations of both drugs without minimum or maximum concentration limits without using the Narcotrend monitor only depend on the experience of anesthesiologist.
16106188|NCT02116972|Drug|FX006 32 mg|Single 5 mL IA injection
16106189|NCT02116972|Drug|Placebo|Single 5 mL IA injection
16106190|NCT02116972|Drug|FX006 16 mg|Single 5 mL IA injection
16106191|NCT02116959|Drug|Melphalan|
16106192|NCT02116959|Drug|Carboplatin|
16106193|NCT02116959|Drug|Etoposide|
16106194|NCT02116959|Drug|Vincristine|
16106195|NCT02116946|Biological|Platelet Rich Plasma (PRP)|Injection of Leukocyte-rich or Leukocyte-poor Platelet Rich Plasma prepared by the Angel cPRP System along with a 12 week exercise program for treatment of patients with patellar tendinopathy.
16106196|NCT02116946|Other|Saline + exercise|Peritendinous saline injection plus 12 week exercise program.
16106197|NCT02116933|Procedure|Adipose Derived Stem Cells|Adipose derived stem cells harvested from autologous lipoaspirate
16106198|NCT02116933|Procedure|SVF Enriched Autologous Fat Grafting|Cell assisted lipotransfer
16106199|NCT02116907|Drug|E2007|14C-labeled perampanel dissolved in ethanol and administered using a capsule formulation in a single dose, one day
16106200|NCT02116894|Biological|PF-03446962|PF-03446962 will be an investigational formulation supplied by Pfizer . PF-03446962 injection, 10 mg/mL is presented as a sterile solution for IV administration in a formulation consisting of precedented excipients. We will be administering PF-03446962 intravenously at a starting dose of 4.5 mg/kg and escalating to up to 7 mg/kg.
16106201|NCT02116894|Drug|Regorafenib|We will be administering regorafenib on-label for the indication of metastatic colorectal cancer. The indicated dose is 160 mg once daily for the first 21 days of a 28 day cycle. We will start at a regorafenib dose of 120 mg in the combination therapy, but may increase to 160 mg during dose escalation.
16106202|NCT02116881|Procedure|Colorectal Surgery|Application of postoperative questionnaires will be completed by patients. The intervention is the standard of care.
16106203|NCT02116868|Device|Pupillometry guided analgesia (PP)|Analgesia is guided by pupillary reflex provided by the pupillometer (AlgiScan). The anesthesiologist in charge must adjust the peroperative remifentanil dose (Target controlled infusion) during surgery according to the algorithm proposed (Tailored remifentanil controlled infusion). Administration of antihypertensive drugs or vasopressors is also guided.
16106541|NCT02114502|Drug|Pyridoxine|100 mg by vein or mouth three times a day from Day -1.
16106204|NCT02116868|Drug|Tailored remifentanil controlled infusion|The anesthesiologist in charge must adjust the peroperative remifentanil dose (Target controlled infusion) during surgery according to the algorithm proposed
16106205|NCT02116868|Drug|Tailored antihypertensive drug administration|Administration of antihypertensive drugs or vasopressors is guided by the results of the pupillary reflex.
16106206|NCT02116855|Other|according to the efficacy of AJBRs|
16106207|NCT02116842|Drug|0.1% bupivacaine|Epidural block in early labour.
16106208|NCT02116842|Drug|0.075% bupivacaine|Epidural block in early labour.
16106209|NCT02116842|Drug|40 µg fentanyl|Given with different doses of bupivacaine in epidural block.
16106210|NCT02116829|Other|Danish butter|The effect of butter intake versus olive oil (refined) intake on blood lipids (primarily)
16106211|NCT02116829|Other|Olive oil|
16106212|NCT02116816|Dietary Supplement|Polyphenol|Polyphenol
16106213|NCT02116803|Drug|dovitinib|Dovitinib was available in two formulations: capsules of 100 mg strength, and tablets of 100 mg strength and taken orally.
16106214|NCT02116803|Drug|fulvestrant|Fulvestrant is generally available as solution for injection in pre-filled syringes containing 250 mg of fulvestrant in 5 mL solution.
16106215|NCT02116790|Drug|Naproxen|Subjects will take one 250mg Naproxen capsule
16106216|NCT02116790|Drug|Sinemet|Subjects will take one 12.5mg/50mg Sinemet.
16106217|NCT02116790|Drug|Sinemet|Subjects will take one 25mg/100mg Sinemet.
16106218|NCT02116790|Drug|Placebo|Subjects will take two placebos.
16106219|NCT02116777|Other|Laboratory Biomarker Analysis|Correlative studies
16106220|NCT02116777|Other|Pharmacological Study|Correlative studies
16106221|NCT02116777|Drug|Talazoparib|Given PO
16106222|NCT02116777|Drug|Temozolomide|Given PO
16106223|NCT02116738|Procedure|Flap Transposition Procedures|Modified Limberg Flap Transposition Procedure and Lateral Advancement Flap Transposition with Burrow's Triangle Procedure in The treatment of Pilonidal Sinus Diseases
16106224|NCT02116725|Other|Shower gel with zinc|Standard shower gel (Sanex) supplemented with zinc sulfate.
16106225|NCT02116725|Other|Plain shower gel|Standard shower gel (Sanex).
16106226|NCT02116725|Other|Distilled water|Sterile distilled Water.
16106227|NCT02116712|Drug|Saracatinib|Saracatinib is escalated as follows: Three dose levels will be administered for 1 month each: 50 mg, 125 mg and 175 mg. Three subjects will be treated at the lowest daily dose of 50 mg. If no subject experiences DLT (dose limiting toxicity), the dose level is escalated to 125 mg/day for the next cohort of 3 different subjects and so on to next dose.
16106228|NCT02116699|Other|oropharyngeal mother's milk|Application of 0.2 mL of own mother's milk onto the infant's oral mucosa, for an initial treatment period of every 2 hours for 48 hours, followed by an extended treatment period of every 3 hours until 32 weeks corrected gestational age
16106229|NCT02116699|Other|oropharyngeal sterile water|Application of 0.2 mL of sterile water onto the infant's oral mucosa, for an initial treatment period of every 2 hours for 48 hours, followed by an extended treatment period of every 3 hours until 32 weeks corrected gestational age
16106230|NCT02116686|Device|ventilatory polygraphic recordings|Standard nocturnal in-home ventilatory polygraphic recordings were performed using an Embla device (Embla®, Broomfield, USA) and scored according to the AASM recommendations (RemLogic® software, Broomfield, USA).
16106231|NCT02116673|Other|Cognitive rest|The intervention is providing discharge instructions instructing cognitive rest and graduated return to usual activities in patients whom have experienced minor traumatic brain injury.
16106232|NCT02116673|Other|Usual care|These are usual care emergency department discharge instructions provided at emergency department discharge for minor traumatic brain injury.
16106233|NCT02116660|Drug|Raltegravir (MK-0518)|Raltegravir (MK-0518) 400 mg tablets
16106234|NCT02116660|Drug|Nevirapine|Nevirapine (NVP) 200 mg tablets
16106235|NCT02116660|Drug|Lamivudine|Lamivudine (3TC) 150 mg tablets
16106236|NCT02116660|Drug|Tenofovir|Tenofovir disoproxil fumarate (TDF) 300 mg tablets
16106237|NCT02116660|Drug|Emtricitabine|Emtricitabine (FTC) 200 mg tablets
16106238|NCT02116660|Drug|Lopinavir|Lopinavir (LPV) 200 mg tablets
16106239|NCT02116660|Drug|Ritonavir|Ritonavir (r) 100 mg tablets
16106240|NCT02116660|Drug|Atazanavir|Atazanavir (ATV) 300 mg tablets
16106241|NCT02116660|Drug|Darunavir|Darunavir (DAR) 400 mg tablets
16106242|NCT02116647|Behavioral|Psychoanalytic therapy|
16106243|NCT02116634|Biological|mesenchymal stem cell|intra spinal injection of 1 ×10(8) mesenchymal stem cells +10cc normal saline
16106244|NCT02116621|Behavioral|Trialist Intervention|Clinician and patient set up N-of-1 trial and patient uses Trialist smartphone app to answer daily questions about pain and associated side effects.
16106245|NCT02116621|Device|smartphone|
16106246|NCT02116608|Drug|Betadine|Apply locally as needed.
16106247|NCT02116608|Drug|Silver Nitrate|Arzol Silver Nitrate Applicators may be applied directly to mucous membranes and other moist surfaces. In the case of dry skin, the applicator tip should be dipped in water immediately before use. Apply carefully to the area to be treated.
16106248|NCT02116608|Drug|Hydrocortisone Butyrate Cream, 1.0%|Hydrocortisone butyrate cream, 1.0% should be applied to the affected area as a thin film two or three times daily depending on the severity of the condition.
16106249|NCT02116595|Other|high or low acid diet|high or low acid diets
16106250|NCT02116582|Drug|Enzalutamide|Participants received 160 mg of enzalutamide (soft capsules) orally once daily.
16106251|NCT02116569|Drug|Daratumumab|Participants will be administered intravenously with daratumumab at a dose of 8 or 16 mg/kg up to 8 weeks (total 7 infusions). After 8 weeks, participants will receive daratumumab intravenously at a same dose, two times in every 2 weeks until Week 24 followed by one time in 4 weeks until study discontinuation. If the dose exceeds 24 mg/kg, then it will be considered as overdose in this study.
16106252|NCT02116556|Drug|Prednisone|Prednisone PO 40mg/day or IV equivalent dosage for 30 days. Patients not responding at 7 days (e.g. Lille Model ≥ 0.45) treatment with Prednisone will be suspended.
16106253|NCT02116556|Drug|Rifaximin|Rifaximin PO 1200 mg/day for 90 days
16106254|NCT02116543|Drug|TD-6450|
16106255|NCT02116543|Drug|Placebo|
16106256|NCT02116530|Drug|Olanzapine|oral
16108200|NCT02102308|Other|Exercise|Multicomponent exercise
16106258|NCT02116530|Drug|Antiemetic treatment (ondansetron or granisetron or palonosetron; plus dexamethasone; plus fosaprepitant or aprepitant)|oral or IV
16106259|NCT02116530|Other|Placebo|oral
16106260|NCT02116517|Dietary Supplement|green tea extract|500 mg three times per day
16106261|NCT02116517|Dietary Supplement|Placebo|cellulose 500mg three times a day for 6 weeks
16106262|NCT02116504|Procedure|Sampling of blood|Sampling of blood for dosage of antibodies
16106263|NCT02116491|Device|Visual Sputum Suctioning System|All ES procedures were performed on indication by RICU nurses and according to protocol, according to which Closed suction system was performed which the patient remained connected to the ventilator. The double-lumen catheter of the Visual Sputum Suctioning System integrated with a 0.9-mm micro-imaging fiber was inserted into the endotracheal tube until resistance was met and withdrawn 0.5 cm. A negative pressure of maximum 150mmHg was set, and the catheter was withdrawn while gently rotating. The procedure lasted for a total of 10 seconds. Nonsterile gloves were to be used during all procedures.
16106264|NCT02116478|Procedure|surgical proximal medial gastrocnemius recession|proximal medial gastrocnemius recession
16106265|NCT02116465|Drug|Levodopa Carbidopa immediate release tablets|oral administration
16106266|NCT02116452|Dietary Supplement|Supplemented Formula|50:50 mixture of GOS/PDX formula will be administered
16106267|NCT02116426|Biological|Blood work in the ambulance|Blood sample for copeptin and troponin HS testing is taken during ambulance care.
16106268|NCT02116426|Biological|Blood work upon arrival in the emergency room|Blood in drawn for copeptin and troponin HS testing upon arrival in the emergency room.
16106269|NCT02116426|Biological|Blood work at 3 hours post-arrival in the emergency room|Blood is drawn for troponin HS testing 3 hours after the patient's arrival in the emergency room.
16106270|NCT02116413|Procedure|Fluid challenge|The fluid challenge starts at minute 0 (T0) and consists of 500ml of crystalloids over 10 minutes.
16106271|NCT02116413|Procedure|Cardiac ultrasound|Ultrasound measures are made at T0, T2, T4, T6, T8, T10, T20 and T30.
16106272|NCT02116400|Other|Interview|All patients are interviewed at the BEC. Questionnaires and scores are administered. See endpoints.
16106273|NCT02116400|Other|Neuropsychological testing|Neuropsychological tests are administered (requires computer use). See endpoints.
16106274|NCT02116400|Biological|Serum concentration of lithium or sodium divalproate.|Venous blood is drawn and tested for serum concentration of lithium or sodium divalproate.
16106275|NCT02116387|Other|Routine Physical Therapy|Patients randomized to this arm will participate in a classic physical therapy program (15 weeks, a total of 15 sessions).
16106276|NCT02116387|Device|I-Moove Physical Therapy|Patients randomized to this arm will participate in a physical therapy program using the I-Moove device (15 weeks, a total of 15 sessions).
16106277|NCT02116374|Other|Physiopathology study|
16106278|NCT02116361|Biological|onabotulinumtoxinA|OnabotulinumtoxinA injected into protocol-specified areas on Day 1.
16106279|NCT02116361|Drug|Normal Saline|Placebo (normal saline) injected into protocol-specified areas on Day 1.
16106280|NCT02116348|Drug|Cerebrolysin (Nerve growth factor)|Cerebrolysin will be given to the intervention group
16106281|NCT02116335|Drug|Bosentan|Stress response and vascular function will be assessed 3 days following 125 mg twice per day of Bosentan
16106282|NCT02116335|Drug|Placebo|Stress response and vascular function will be assessed 3 days following twice per day placebo
16106283|NCT02116322|Procedure|EUS-FNA with Corkscrew technique|
16106284|NCT02116322|Device|Expect 19 G Flex needle|
16106285|NCT02116309|Drug|Rectal Indomethacin|
16106286|NCT02116309|Drug|Epinephrine|
16106287|NCT02116296|Behavioral|ToyBox-intervention|
16106288|NCT02116283|Behavioral|48 hour smoking abstinence|Participants will maintain smoking abstinence for 48 hours
16106289|NCT02116283|Other|Smartphone|Participants will use an Android-based smartphone as their own for one month
16106290|NCT02116270|Biological|Blood sample|3 tubes of 5 ml tubes and 4 of 7 ml for biological assays at t0.
16106291|NCT02116257|Drug|Propacetamol|total 4g of Propacetamol added to patient's PCA regimen
16106292|NCT02116257|Drug|PCA regimen|
16106293|NCT02116244|Drug|Civamide Nasal Spray|
16106294|NCT02116231|Drug|Concurrent chemotherapy with cisplatin|Three cycles of weekly Cisplatin 100 mg/m2 starting on the first day of IMRT
16106295|NCT02116231|Radiation|Intensity modulated radiotherapy|Intensity modulated radiotherapy is a technique of radiotherapy.
16106296|NCT02116218|Procedure|acupuncture|Acupuncture in the Hegu (LI4), Shousanli (LI10), Zusanli (ST36), Yanlinquan (GB34), Taichong (LV3) and Ouch point. Needles would be correctly inserted and manually stimulated until the 'De Qi' sensation is elicited. The needles would stay in place for 15 minutes.
16106297|NCT02116218|Procedure|Vaccaria seed|We put Vaccaria seeds near the acupoints without acupressure as an intervention in control group.
16106298|NCT02116205|Biological|HTNV/PUUV DNA vaccine|HTNV/PUUV DNA vaccine mixture, composed of pWRG/HTN-M(co) and pWRG/PUU-M(s2)
16106299|NCT02116205|Biological|Placebo|0.9% sodium chloride
16106300|NCT02116205|Device|TriGrid Delivery System (TDS)|The TDS-IM is an integrated, fully automated clinical EP system designed for delivering DNA-based vaccines and therapies to target tissues, through temporary disruption of cellular membranes via electrical pulses
16106301|NCT02116192|Behavioral|Experimental: Low-fructose, reduced carbohydrate diet|"Low Carbohydrate (Low Fructose and Sucrose) Diet (Prescribed Hypocaloric regimen to promote 7% initial weight loss via 25-30kCal/kg;40-45% CHO, 20-25% Protein, 30-40% Fat)
~● Aim for less than 25g fructose daily."
16106302|NCT02116192|Behavioral|General Healthy Diet|Prescribed Hypocaloric regimen to promote 7% initial weight loss via 25-30kCal/kg; 50-60% CHO, 15-20% Protein, 20-30% Fat
16106303|NCT02116179|Behavioral|DVD Intervention|Participants will be randomly assigned, with a baseline and 3 month follow up assessments
16106304|NCT02116140|Other|[C11]Acetate and HED PET|
16106305|NCT02116127|Device|Active tDCS|The intervention is active 2mA transcranial direct current stimulation (tDCS). Direct current will be transferred with a pair of saline soaked sponge electrodes (contact area 5 x 7cm), and delivered for 30 minutes. The electrodes will be placed over F3 and F4 according to the 10-20 international system for EEG placement.
16106542|NCT02114489|Drug|ibandronate|Unique perfusion of ibandronate 3 mg IV
16106306|NCT02116127|Device|Sham tDCS|The sham intervention is transcranial direct current stimulation (tDCS). 2mA of direct current will be transferred with a pair of saline soaked sponge electrodes (contact area 5 x 7cm), and the current will be turned off after 54 seconds.The electrodes will be placed over F3 and F4 according to the 10-20 international system for EEG placement.
16106307|NCT02116114|Other|Aerobic training|The program of aquatic exercise training was developed involving the following steps : heating : dynamic stretching exercises aerobic exercises , lasting 10 minutes was performed, aquatic fitness : aerobic training and slowdown. The intensity was prescribed based on the Borg scale score 4-6. Aerobic training was performed at intervals. The duration of aerobic fitness was started with eight 20-minute sessions , progressing to eight sessions of 30 minutes and finished with eight 40-minute sessions. Downturn : global stretching exercises , lasting 10 minutes were performed. During all sessions , the patients were instructed to breath with pursed - lip .
16106308|NCT02116101|Dietary Supplement|Bright Momchilovtsi Yogurt|"Oral consumption of Bright Momchilovtis Yogurt containing 1×106cfu/g prebiotics including Lactobacillus bulgaricus and Streptococcus thermophilus
~Dosage: 110g at a time, twice per day at 10 am and 4 pm. Duration: 7 weeks (March 10, 2013 - April 27, 2013) The active study product has similar package and taste as the placebo."
16106309|NCT02116101|Dietary Supplement|Bright Dairy Beverage|Oral consumption of Bright Dairy Beverage Dosage: 110g at a time, twice per day at 10 am and 4 pm. Duration: 7 weeks (March 10, 2013 - April 27, 2013) The active study product has similar package and taste as the placebo.
16106310|NCT02116088|Behavioral|Teacher Coaching|
16106311|NCT02116075|Procedure|Epidural Prolotherapy|caudal injection of 10mL 5% dextrose
16106312|NCT02116075|Procedure|Epidural Steroid|caudal injection of 1mL 80mg depo-medrol with 9ml of 1% lidocaine
16106313|NCT02116062|Device|1. Amniotic membrane transplantation on the cornea with the Da Vinci Si HD© robot (Inlay or overlay technique)|
16106314|NCT02116062|Device|Pterygium removal and autograft of the conjunctiva with the Da Vinci Si HD© robot (Kenyon technique)|
16106315|NCT02116062|Device|Penetrating keratoplasty using Baron trephine and nylon stitches with the Da Vinci Si HD© robot|
16106316|NCT02116049|Behavioral|Disclosure Intervention|The experimental condition is a 4-session + 3 month booster intervention. Session 1 includes an introduction to the project, goal setting, assessment of disclosure strategies or tactics utilized, and disclosure triggers. Session 2 focuses on the costs and benefits of disclosing to casual sexual partners and previous best and worst disclosure experiences. Session 3 begins with the delivery of the encouraging messages and review of the disclosure strategies already employed. Session 4 is a continuation of session 3 activities with an additional focus on expanding the participant's repertoire of strategies; discussion of methods of sexual negotiation, and rehearsal. The booster session includes a discussion of what strategies have been used in the preceding months, which strategies worked and how can these be enhanced, which strategies did not work with opportunities for troubleshooting, and an examination of rewards experienced or costs encountered.
16106317|NCT02116049|Behavioral|Attention Control Case Management|Comprehensive Risk Counseling and Services (CRCS) will be used to guide the case management activities. CRCS combines traditional case management and HIV risk-reduction in an individualized, client-centered program which focuses on the reduction of risk behavior and addresses a client's psychosocial and medical needs. CRCS focuses on seven core elements: recruitment and engagement; screening, enrolling, and assessing; prevention planning; risk reduction counseling; referrals and service coordination; monitoring; and discharge and maintenance.
16106318|NCT02116036|Drug|Rivaroxaban|
16106319|NCT02116023|Other|Orange flavored beverage|
16106320|NCT02116010|Drug|E. coli Phages cocktail|Use of Pherecydes Pharma Phages cocktail to treat respectively E. coli burn wound infection
16106321|NCT02116010|Drug|Standard of care : Silver Sulfadiazine|Use of Standard of care : Silver Sulfadiazine, to treat E. coli or P. aeruginosa infected burn wound
16106322|NCT02116010|Drug|P. Aeruginosa, Phages cocktail|Use of Pherecydes Pharma Phages cocktail to treat P. aeruginosa burn wound infection
16106323|NCT02115997|Drug|Methylprednisolone|Methyprednisolone will be administered 1 to 3 pulses at a dose of 1000 milligram (mg) IV at the discretion of the investigator.
16106324|NCT02115997|Drug|Prednisone|Prednisone will be administered orally at tapered dose (start at 1 milligrams per kilogram per day [mg/kg/day]) at the discretion of investigator given daily until participants are off the drug.
16106325|NCT02115997|Drug|Rituximab|Rituximab will be administered at 375 milligrams per meter square (mg/m^2) of body surface area given by IV infusion once weekly from Week 1 to 4.
16106326|NCT02115984|Drug|Panagen|
16106327|NCT02115984|Drug|Placebo|
16106328|NCT02115984|Procedure|Chemotherapy|Chemotherapy course includes 500 mg/m2 cyclophosphan, 50 mg/m2 doxorubicin, and 500 mg/m2 fluorouracil administered intravenously in one day.
16106329|NCT02115971|Other|Jumping exercise|Total 120min exercise
16106330|NCT02115971|Other|Strength exercise|Total 120 min exercise
16106331|NCT02115958|Biological|cancer stem cell vaccine|
16106332|NCT02115945|Other|DN4 test|The DN4 test was used to evaluate neuropathic pain.
16106333|NCT02115945|Other|The SF 12 test|The SF 12 test (SHORT FORM 12) was used to evaluate quality of life.
16106334|NCT02115945|Other|HAD scale|The anxiety/depression scale (HAD) was used to assess anxiety and depression.
16106335|NCT02115945|Other|Visual analogue score|Visual analogue score vas used to evaluate pain.
16106336|NCT02115945|Procedure|femoral block|
16106337|NCT02115945|Procedure|epidural block|
16106338|NCT02115932|Other|Strength & Balance Training|Subjects will be guided through 8 weeks (1 hour per week) of home-based strength and balance training sessions. During each session, a trainer will guide subjects to perform muscle strengthening, range of motion, static balance, dynamic balance and endurance exercises, after an initial warm up. They will also be given advice on continuing such training as well as daily walking for the rest of the week.
16106339|NCT02115919|Drug|Leukocyte Interleukin, Injection 200IU|Cohort A participants will receive 200IU Multikine perilesional injections once daily, Monday through Friday, for 14 days, then 14 days off with out any Multikine injections received. After the 14 days without receiving the Investigational Product injections they will begin a second round of 200IU Multikine perilesional injections once daily, Monday through Friday for 14 days.
16106543|NCT02114489|Drug|Placebo|
16108201|NCT02102308|Other|Education classes|
16106340|NCT02115919|Drug|Leukocyte Interleukin, injection 400IU|Cohort B participants will receive 400IU Multikine perilesional injections once daily, Monday through Friday, for 14 days, then they will not receive any Multikine perilesional injections for 14 days. After the 14 day rest period when the participants did not receive the Investigational Product injections they will begin a second round of 400IU Multikine perilesional injections every day, Monday through Friday, for 14 days.
16106341|NCT02115906|Other|1H/31P Magnetic Resonance Spectroscopy|The 31P-MRS examinations will be performed in a 7 T MR system (Siemens Healthcare, Erlangen, Germany) using a double-tuned (31P/1H) surface coil (Rapid Biomedical Ltd, Rimpar, Germany), with a diameter of 10 cm. Participants will be investigated lying in lateral position with the right lobe of the liver positioned over the coil.
16106342|NCT02115906|Other|oral glucose tolerance testing|"In patients without overt diabetes, glucose tolerance will be assessed by an oral glucose tolerance test, routinely performed at the outpatients clinic. The test will be performed in the morning after an overnight fast of at least 8 hours. Blood will be drawn via a catheter placed in an antecubital vein of one arm. Blood samples for the assessment of glucose, insulin, C-peptide, free fatty acids and growth hormone will be drawn at baseline as well as 30, 60, 90 and 120 minutes after ingestion of 75g glucose in a solution.
~Concentrations of glucose, insulin and C-peptide will be used to derive parameters of insulin secretion and insulin sensitivity by mathematical modelling."
16106343|NCT02115906|Other|Thyroid sonography|In acromegalic patients thyroid morphology will be assessed at the outpatient clinic of the Division of Endocrinology and Metabolism, using standard ultrasound technique. Measurements will be performed by a well- experienced physician at baseline and at each follow up examination in an out-patient care setting.
16106344|NCT02115893|Dietary Supplement|Sodium Nitrate|
16106345|NCT02115893|Dietary Supplement|Sodium Chloride|
16106346|NCT02115880|Behavioral|Prevention programme|Based on a group- and family-based cognitive behavioural manual developed by Bruce Compas and colleagues in the USA, and adapted for a German sample. The programme is for parents and children and consists of 8 weekly sessions and 4 monthly booster sessions.
16106347|NCT02115867|Dietary Supplement|Probiotic|Symprove probiotic
16106348|NCT02115854|Other|labial biopsy|
16106349|NCT02115841|Device|"Enraf-Nonius Muscle stimulator"|The order 15Hz TENS stimulation session and sham stimulation session will also be randomized.
16106350|NCT02115828|Drug|Vismodegib|
16106351|NCT02115815|Biological|Placebo|Participants will receive placebo (sterile saline for human use from commercial source liquid) on Day 1.
16106352|NCT02115815|Biological|RSV sF 20 mcg|Participants will receive single dose of 20 mcg RSV sF by intramuscular injection on Day 1.
16106353|NCT02115815|Biological|MEDI7510 (20 mcg RSV sF)|Participants will receive single dose of MEDI7510 containing 20 mcg RSV sF by intramuscular injection on Day 1.
16106354|NCT02115815|Biological|RSV sF 50 mcg|Participants will receive single dose of 50 mcg RSV sF by intramuscular injection on Day 1.
16106355|NCT02115815|Biological|MEDI7510 (50 mcg RSV sF)|Participants will receive single dose of MEDI7510 containing 50 mcg RSV sF by intramuscular injection on Day 1.
16106356|NCT02115815|Biological|RSV sF 80 mcg|Participants will receive single dose of 80 mcg RSV sF by intramuscular injection on Day 1.
16106357|NCT02115815|Biological|MEDI7510 (80 mcg RSV sF)|Participants will receive single dose of MEDI7510 containing 80 mcg RSV sF by intramuscular injection on Day 1.
16106358|NCT02115802|Device|Activa PC+S|Subjects will undergo placement of bilateral standard Deep Brain Stimulation (DBS) electrodes (Medtronic model 3387/3389) and implantation of the Activa PC+S, a modified impulse generator (IPG) for DBS with the added technology of neural signal recording.
16106359|NCT02115789|Behavioral|Visual Analog Scale|"Subjects will review examples of both linear and zigzag scars and rate the aesthetic appearance of both configurations of scars on a scale of 1 through 10, with 1 being normal skin and 10 being the worst scar imaginable."
16106360|NCT02115776|Drug|Amoxicillin-Potassium Clavulanate|Administer Amoxicillin-Potassium Clavulanate following endotracheal intubation prior to single tooth-extraction
16106361|NCT02115776|Drug|Amoxicillin|Administer Amoxicillin following endotracheal intubation prior to single tooth-extraction
16106362|NCT02115776|Drug|Chlorhexidine|Administer Chlorhexidine Digluconate following endotracheal intubation prior to single tooth extraction
16106363|NCT02115763|Drug|Caffeine|
16106364|NCT02115763|Drug|Placebo|
16106365|NCT02115750|Drug|Etanercept|Head-to-head comparison
16106366|NCT02115750|Drug|CHS-0214|
16106367|NCT02115737|Behavioral|Dialectical Behavior Therapy Skills Group|
16106368|NCT02115737|Behavioral|Psychoeducation group treatment|
16106369|NCT02115724|Dietary Supplement|Antioxidant cocktail|Flow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment
16106370|NCT02115724|Other|Biopsy|Under sterile conditions, a small incision (¼ - ½ inch) by the study doctor will be made and the piece of fat will be taken out. Fat tissue was chosen for this study because it is a big source of small blood vessels which we are studying
16106371|NCT02115724|Other|Placebo|Flow-Mediated Dilation will be determined at baseline and 2 hours following acute antioxidant treatment
16106372|NCT02115724|Drug|NMD; 0.4mg sub-lingual nitroglycerin spray|Nitroglycerin mediated dilation will be measured immediately following an administered 0.4mg dose of nitroglycerin spray, sub-lingual.
16106373|NCT02115711|Behavioral|Community health worker|The intervention is a multi-component one that is tailored to the individual and will target lifestyle changes, health seeking behavior and medication compliance. The CHW, after identifying the cardiovascular risk factors, will give advice about lifestyle interventions and will encourage hypertensives and diabetics to seek a physician. The first phase of the intervention will target hypertension, while the second phase which will be introduced 6 months after the first visit will target diabetes and smoking. The CHW will continue visiting the home of the participants every 2 months to reinforce the previous recommendations, seek to address reasons for non-adherence, address knowledge deficits and encourage physician visits.
16106374|NCT02115698|Procedure|Heavy Resistance Training|Supervised Heavy Resistance Training three times weekly for 52 weeks.
16106375|NCT02115698|Procedure|Light Intensity Training|Home-based Light Intensity Training three-five times weekly for 52 weeks.
16106376|NCT02115698|Dietary Supplement|Protein Whey|Two daily 20 g whey protein and 10 g carbohydrate supplementations for 52 weeks.
16106377|NCT02115698|Dietary Supplement|Protein Collagen|Two daily 20 g collagen protein and 10 g carbohydrate supplementations for 52 weeks.
16106378|NCT02115698|Dietary Supplement|Carbohydrate|Two daily 30 g carbohydrate supplementations for 52 weeks.
16106379|NCT02115685|Other|Treadmill Training|Subjects will be randomized to a high intensity and low intensity group. The high intensity group will train at 70-80% of their HRR and the low intensity group will train at 30-40% of their HRR.
16106380|NCT02115672|Drug|BL-8040|BL-8040 will be added to imatinib to improve CML response.
16106381|NCT02115659|Drug|Triptolide-Containing Formulation|Triptolide-Containing Formulation (1mg/kg/d) plus standard treatment of complications. Anti-hypertension drug(s) for hypertension; Antibiotics for cyst infections; cause oriented treatment for flank pain.
16106382|NCT02115659|Drug|Placebo|Placebo plus standard treatment of complications. Anti-hypertension drug(s) for hypertension; Antibiotics for cyst infections; cause oriented treatment for flank pain, etc.
16106383|NCT02115646|Device|fractionated carbon dioxide laser|patients will have serial laser treatments
16106384|NCT02115633|Device|Walkasins ON|Subjects will be wearing a device that works as intended and provides real-time vibrotactile feedback that reflects center of pressure sway.
16106385|NCT02115633|Device|Walkasins OFF|Subjects will be wearing a device that is turned off.
16106386|NCT02115620|Other|Telemedicine|Daily updates on symptoms, weight, vital signs, and relevant labs will be communicated by phone with cardiology nurses at Providence Heart Clinic. Concerning changes in symptoms or signs will trigger a telemedicine clinic visit with a HF specialist using remote video/audio, virtual stethoscope technology, and VZ Cloud managed hosting. The consult will include a virtual face-face interview and physical examination between patient and HF clinician using Cisco Yabber Video, Littman e-stethoscope, and Verizon managed hosting. Medication changes, laboratory testing, additional virtual visits, or in-person clinic visits can be arranged as appropriate.
16106387|NCT02115607|Drug|Definity infusion|3 ml of Perflutren Lipid Microspheres (Definity) mixed in 50 ml of saline is infused at a rate of approximately 4ml/min
16106388|NCT02115594|Drug|Fulvestrant|
16106389|NCT02115594|Drug|Entinostat|
16106390|NCT02115594|Drug|Placebo|
16106391|NCT02115581|Drug|Coenzyme Q10|dose of 2 mg/kg/day in 2 or 3 divided doses and increased to the maximum dose of 10 mg/kg/day according to the patient's tolerance
16106392|NCT02115581|Drug|Placebo|dose of 2 mg/kg/day in 2 or 3 divided doses and increased to the maximum dose of 10 mg/kg/day according to the patient's tolerance
16106393|NCT02115555|Behavioral|HIT-aided approach|Subjects randomized to this approach will be using the HIT-aided monitor.
16106394|NCT02115555|Behavioral|Contracted conflict management system|Subjects randomized to this arm will be using the behavioral contracted conflict management system.
16106395|NCT02115555|Behavioral|HIT plus contracted conflict management|Subjects randomized to this arm will use both the HIT-aided approach and the behavioral contract conflict management system.
16106396|NCT02115542|Drug|Regorafenib|Four 40 mg regorafenib tables should be taken in the morning with approximately 8 fluid ounces (240 mL) of water after a low-fat (<30% fat) breakfast.
16106397|NCT02115529|Drug|Nabilone|Nabilone (0.5 mg) or placebo given preoperatively
16106398|NCT02115529|Drug|Placebo|Placebo Comparator: identical capsule containing placebo (single dose) given preoperatively
16106399|NCT02115516|Biological|PfSPZ Challenge|Aseptic, purified, vialed, cryopreserved, infectious P. falciparum sporozoites, strain NF54
16106400|NCT02115516|Biological|0.9% Sodium Chloride (Placebo)|
16106401|NCT02115490|Drug|Bisphosphonates|
16106402|NCT02115477|Procedure|Lymphadenectomy|Pelvic and/or paraaortic lymphadenectomy
16106403|NCT02115464|Drug|Metformin plus Chemo-radiotherapy|Metformin 2000 mg a day for 12 months plus cisplatin-based chemotherapy with or without consolidation with standard radiotherapy of 60-63 Gy for 6 weeks.
16106404|NCT02115464|Radiation|Chemo-radiotherapy|Cisplatin-based chemotherapy with or without consolidation with standard radiotherapy of 60-63 Gy for 6 weeks.
16106405|NCT02115425|Other|Body Measurements|A series of body measurements will be taken by trained staff. These measurements include height and weight. These measurements will be completed twice during this time. You will wear a hospital gown and bathing suit for these measurements.
16106406|NCT02115425|Other|Whole Body DXA Scan|This scan measures the amount of bone, muscle, and fat in your body. The scan will be performed using a whole-body scanner. You will be required to wear a hospital gown, to remove all metal-containing objects from your body, and to lie down on the table.
16106407|NCT02115425|Other|Bioelectrical Impedance Analysis (BIA)|These tests will measure the amount of fat in your body. You will be asked to change into a hospital gown and to remove all footwear and socks/stockings. Once changed and barefoot, you will be asked to stand on a scale (similar to a large gym scale) and to hold on to hand electrodes on each side of the scale. You will be asked to step off of the scale once the measurement is complete (less than one minute). You will also hold on to hand electrodes for three other BIA systems.
16106408|NCT02115425|Other|Bioelectrical Impedance Analysis (BIA)|These tests will measure the amount of fat in your body. You will be asked to change into a hospital gown and to remove all footwear and socks/stockings. You will be asked to hold on to hand electrodes on a hand hold device. You will be asked to complete 3 measurement (less than one minute). You will also hold on to hand electrodes for two other BIA systems.
16106409|NCT02115425|Other|add name here|
16106410|NCT02115386|Drug|Nilotinib|supplied in 150 mg capsules to be taken orally
16106411|NCT02115373|Drug|Tepotinib|Participants received a single oral dose of Tepotinib 300 milligram (mg) in each 21 days treatment cycle until progressive disease, intolerable toxicity, death, or withdrawal from treatment.
16106412|NCT02115373|Drug|Tepotinib|Participants received a single oral dose of Tepotinib 500 mg daily in each 21 days treatment cycle until progressive disease, intolerable toxicity, death, or withdrawal from treatment.
16106492|NCT02114814|Behavioral|Diabetes self-management program for Hispanics and their families|The intervention group received an 8-weekly culturally tailored diabetes self-management and family support education program delivered in Spanish
16106493|NCT02114814|Behavioral|General health educational program for Hispanics and their families|The attention control group received 8-weekly education program on general health information
16106494|NCT02114801|Device|manual brushing|Tooth brushing
16106413|NCT02115360|Drug|Calcitonin|Under full aseptic conditions, the epidural space was identified at the L 2-3 or L 3-4 lumbar interspace using the loss-of-resistance to saline technique using 16-gauge Tuohy needle. A test-dose of 3 mL of a 2% solution of lidocaine with adrenaline (1:200,000) will be given to exclude subarachnoid or intravenous catheter placement. An injection of a2 ml hyperbaric bupivacaine will be injected into the subarachnoid space through 25 gauge spinal needle, then 15ml 0.5% bupivacaine, 100 micrograms of fentanyl and 1ml normal saline will be injected epidurally in Bupivacain- fentanyl (BF) Group, then a 16G Portex catheter was inserted for post- operative analgesia.
16106414|NCT02115360|Drug|Fentanyl|Under full aseptic conditions, the epidural space was identified at the L 2-3 or L 3-4 lumbar interspace using the loss-of-resistance to saline technique using 16-gauge Tuohy needle. A test-dose of 3 mL of a 2% solution of lidocaine with adrenaline (1:200,000) will be given to exclude subarachnoid or intravenous catheter placement. An injection of a2 ml hyperbaric bupivacaine will be injected into the subarachnoid space through 25 gauge spinal needle, then 15ml 0.5% bupivacaine, 100 micrograms of fentanyl and 1ml normal saline will be injected epidurally in Bupivacain- fentanyl (BF) Group, then a 16G Portex catheter was inserted for post- operative analgesia.
16106415|NCT02115347|Drug|Ertugliflozin 15 mg|Tablet
16106416|NCT02115334|Behavioral|professional therapists delivering the PHPA|PHPA are delivered by professional therapists, which including gross motor, fine motor, cognition verbal, social interactions, activity of daily living(ADL).
16106417|NCT02115334|Behavioral|parents executing the PHPA|PHPA are executed by parents, which including gross motor, fine motor, cognition verbal, social interactions, ADL.
16106418|NCT02115334|Behavioral|health education|health education of the children with DD.
16106419|NCT02115321|Drug|Grazoprevir|GZR was supplied as two 25 mg tablets in the Part A CP-B arm, or as either one GZR 100 mg tablet or one fixed-dose combination (FDC) tablet containing GZR 100 mg + EBR 50 mg in a single tablet (MK-5172A) in the Part A NC arm. GZR was taken q.d. by mouth.
16106420|NCT02115321|Drug|Elbasvir|EBR was supplied as 50 mg tablets and was taken q.d. by mouth.
16106421|NCT02115321|Drug|MK-5172A|MK-5172A FDC tablet containing GZR 100 mg + EBR 50 mg taken q.d. by mouth.
16106422|NCT02115308|Drug|Regadenoson|Regadenoson injection is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging.
16106423|NCT02115295|Drug|Cladribine|Given IV
16106424|NCT02115295|Drug|Cytarabine|Given IV
16106425|NCT02115295|Drug|Gilteritinib|Given PO
16106426|NCT02115295|Drug|Idarubicin|Given IV
16106427|NCT02115295|Other|Laboratory Biomarker Analysis|Correlative studies
16106428|NCT02115295|Drug|Midostaurin|Given PO
16106429|NCT02115295|Drug|Venetoclax|Given PO
16106430|NCT02115282|Drug|Entinostat|Given PO
16106431|NCT02115282|Drug|Exemestane|Given PO
16106432|NCT02115282|Drug|Goserelin|Given PO
16106433|NCT02115282|Drug|Goserelin Acetate|Given SC
16106434|NCT02115282|Other|Placebo Administration|Given PO
16106435|NCT02115282|Other|Quality-of-Life Assessment|Ancillary studies
16106436|NCT02115256|Drug|Intravenous Terbutaline|0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline.
16106437|NCT02115256|Drug|Intravenous Nitroglycerine|The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it's short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.
16106438|NCT02115243|Drug|Ipilimumab|
16106439|NCT02115230|Procedure|Renal denervation + medical therapy|Renal denervation + medical therapy Renal sympathetic denervation with an irrigated radiofrequency catheter with Celsius Thermocool (Biosense Webster, California, USA) + standard optimized medical therapy for diastolic heart failure
16106440|NCT02115217|Device|Leukotape K|All interventions will be performed by a qualified physiotherapist in a standardized manner. Tape will be extended to the recommended length (120%) and applied along the outer side of the leg, along the path of the peroneal muscle. Starting in the middle of the foot arch, the tape ends 1 cm below tibial head.
16106441|NCT02115217|Device|Sham kinesiotape|KT put with no effects
16106442|NCT02115204|Drug|Epirubicin|
16106443|NCT02115204|Drug|Cyclophosphamide|
16106444|NCT02115204|Drug|Docetaxel|
16106445|NCT02115204|Drug|Methotrexate|
16106446|NCT02115204|Drug|5-fluorouracil|
16106447|NCT02115191|Device|2-octylcyanoacrylate|After sedation with midazolam (0.5 mg/kg orally) a Foley catheterization with a 10 Fr gauge siliconized catheter will be placed, with the balloon inflated with 1.5 ml water to prevent bladder spasm. After this we will apply the adhesive by using dissecting forceps to approximate the edges of the UCF, and then apply it several thin layers of OCA.
16106448|NCT02115191|Procedure|Surgical reintervention|The reoperation will consist on mobilizing dartos flaps and closing the defect in layers with absorbable sutures. Urinary bladder drainage will be provided with a 10 Fr silicone Foley catheter, with the balloon inflated with 1.5 ml water to prevent bladder spasm.
16106449|NCT02115178|Other|Lithotomy or Prone position|The surgery, haemodynamic measurements will be performed in Lithotomy or Prone position
16106450|NCT02115165|Drug|Cabazitaxel|On Day 1 of each cycle, patients will receive cabazitaxel at a dose of 25 mg/m², administered by IV route in 1 hour
16106451|NCT02115152|Drug|fluorouracil|
16106452|NCT02115152|Drug|capecitabine|
16106453|NCT02115152|Drug|cyclophosphamide|
16106454|NCT02115152|Drug|Epirubicin|
16106455|NCT02115139|Drug|Ipilimumab|Ipilimumab 3mg/Kg iv q 3 weeks for 4 cycles
16106456|NCT02115126|Biological|LMP2A-loaded conventional DC vaccine|"Vaccine #1 will be administered 9-13 weeks status post peripheral blood stem cell (PBSC) infusion. At the time of vaccination, ANC must be > 1.5.
~Vaccine #2, the booster vaccine, will be administered 4 weeks +/- 7 days status post vaccine #1. At the time of vaccination, ANC must be > 1.5.
~Vaccines will be administered following standard institutional practice for IV infusions using a peripheral or central line and following sterile technique. On the day of vaccination, the patient will be given a total dose of 3 x 107 cells in 30ml of normal saline per vaccination."
16106495|NCT02114801|Device|electric toothbrush linked|Tooth brushing
16106496|NCT02114801|Device|off electric toothbrush|Tooth brushing
16106497|NCT02114788|Other|Internet-based|
16106457|NCT02115126|Biological|DUK-CPG-001|"On the day of vaccination, for those patients who are randomized to receive DUK-CPG-001, a single vial will be dispensed to the nurse, upon request, by Duke ICS. DUK-CPG-001 will be thawed at room temperature right before use and 0.5 ml (5 mg) will be injected subcutaneously immediately after vaccination.
~DUK-CPG-001 will be stored at -20ºC until use. It will be stored in the Duke Investigational Chemotherapy Service pharmacy.
~Using standard institutional guidelines and sterile technique for subcutaneous injections, 5 mg of DUK-CPG-001 will be injected subcutaneously immediately after each vaccination."
16106458|NCT02115113|Drug|Everolimus|Commercial product labeled according to local requirements will be provided as 0.25 mg and 0.75 mg tablets for oral administration.
16106459|NCT02115113|Drug|Tacrolimus|Commercial product labeled according to local requirements will be provided as 0.5 mg, 1.0 mg and 5.0 mg capsules for oral administration.
16106460|NCT02115100|Procedure|procedure|Renal ablation+pulmonary vein isolation OR pulmonary vein isolation only
16106461|NCT02115087|Procedure|ultrasound guided rectus sheath block|the application of rectus sheath block with ultrasound guidance
16106462|NCT02115087|Drug|Morphine|
16106463|NCT02115074|Drug|Fluvastatine|"Escalation dose : Level 1: 2mg/kg/day. Level 2: 4mg/kg/day. Level 3: 6mg/kg/day. Level 4: 8mg/kg/day.
~Per os from D1 to D14 of each 28 day cycle.
~Number of Cycles: until progression or unacceptable toxicity develops."
16106464|NCT02115074|Drug|Celebrex|"Dose levels : 100 mg twice a day (< 20 kg), 200 mg twice a day (20-50 kg), 400 mg twice a day (> 50 kg)
~Per os from D1 to D28 of each 28 day cycle.
~Number of Cycles: until progression or unacceptable toxicity develops."
16106465|NCT02115061|Device|Treatment: coil + cyanoacrylate|This group had fourteen patients who met all inclusion criteria. These will be treated with coil + cyanoacrylate.
16106466|NCT02115061|Device|Treatment: cyanoacrylate|This group owned fourteen patients who met all the inclusion criteria. These will be treated with cyanoacrylate.
16106467|NCT02115048|Drug|Letrozole|
16106468|NCT02115048|Drug|Afatinib|
16106469|NCT02115035|Drug|Vermurafenib|960 mg of Vermurafenib twice daily orally on a 28 day schedule
16106470|NCT02114983|Other|compression ultrasonography|CUS in patients with a high pre-test clinical probability of DVT and/or a positive D-dimer
16106471|NCT02114970|Other|Randomized- paper consent|
16106472|NCT02114970|Other|Randomized- Tablet-delivered consent|
16106473|NCT02114970|Other|Focus Group- paper and tablet consent|
16106474|NCT02114957|Dietary Supplement|800mg dietary supplement CognIQTM (4 capsules) by oral at hour 0|
16106475|NCT02114944|Device|NIV|Patients treated, as per attending physician's decision, with noninvasive ventilation
16106476|NCT02114944|Device|CPAP|Patient treated, as per attending physician's decision, with CPAP
16106477|NCT02114944|Device|Standard oxygen|Patient treated, as per attending physician's decision with standard oxygen therapy either as primary respiratory therapy or rest therapy during breaks off CPAP or NIV
16106478|NCT02114944|Device|HFNC|Patients treated, as per attending physician's decision, with high-flow nasal cannula either as primary therapy or rest therapy during breaks off NIV or CPAP
16106479|NCT02114931|Biological|ABP 501|Solution for subcutaneous injection in a syringe containing 40 mg/0.8 mL ABP 501
16106480|NCT02114918|Behavioral|Attention Modification Program|"Each trial begins with a fixation cross presented in the center of the computer screen for 500 ms. The cross is then replaced by a word pair presented in the center of the screen for 500 ms. The word pair disappears and a probe (i.e., the letter E or F) appears immediately in the location of one of the two words. Participants will be instructed to decide whether the letter is an E or an F and press the corresponding mouse button. This paradigm has been modified to facilitate an attention bias away from threatening material. In this case, the probe always replaces the neutral word. Thus, although there will be no specific instruction to direct attention away from the threat word, on all trials, the position of the neutral word will indicate the position of the probe."
16106481|NCT02114918|Behavioral|Attention Control Condition|"Each trial begins with a fixation cross presented in the center of the computer screen for 500 ms. The cross is then replaced by a word pair presented in the center of the screen for 500 ms. The word pair disappears and a probe (i.e., the letter E or F) appears immediately in the location of one of the two words. Participants will be instructed to decide whether the letter is an E or an F and press the corresponding mouse button. This paradigm is not intended to facilitate an attention bias away from threatening material. In this case, the probe randomly replaces the threat or neutral word."
16106482|NCT02114905|Behavioral|OTs Trained and Deliver CBIT|"CBIT is a highly structured therapy that typically takes place on a weekly basis. The patient is taught to perform a specific behavior that makes the tic more difficult to do, as soon as the tic or urge appears. This competing response helps to reduce, and in some cases, even eliminate the tic. The functional intervention (FI), is based on the fact that certain situations or reactions to tics can make them worse than they might otherwise be. The goal of FI is to identify these situations and have the patient and family attempt to change them so the tics aren't made worse unnecessarily."
16106483|NCT02114892|Drug|Resveratrol|Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day.
16106484|NCT02114892|Drug|Placebo|Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg
16106485|NCT02114879|Behavioral|Enhanced Medical Rehabilitation|Daily PT/OT provided by therapists trained in Enhanced Medical Rehabilitation. This training focuses on improved communication, patient engagement, and intensity.
16106486|NCT02114879|Behavioral|Standard of Care Rehabilitation|Daily PT/OT provided by therapists not trained in the treatment intervention.
16106487|NCT02114840|Procedure|Pronator quadratus preservation after volar plate fixation in wrist fractures|Pronator quadratus preservation after volar plate fixation in wrist fractures
16106488|NCT02114840|Procedure|Pronator quadratus repair after volar plate fixation in wrist fractures|Pronator quadratus repair after volar plate fixation in wrist fractures
16106489|NCT02114840|Procedure|Pronator quadratus nonrepair after volar plate fixation in wrist fractures|Pronator quadratus nonrepair after volar plate fixation in wrist fractures
16106490|NCT02114827|Behavioral|Video|23-minute video
16106491|NCT02114827|Behavioral|FAQ Sheet|
16106498|NCT02114775|Drug|Growth Hormone|0.4 mg/day injected subcutaneously for one month then increased to 0.6 mg/day for two months during crossover phase. After crossover phase, 0.6 mg/day for six months
16106500|NCT02114775|Drug|Placebo|Placebo either injected (GH group) or orally (sildenafil group) daily for three months during crossover phase of the study
16106501|NCT02114762|Procedure|Balloon dilation of the Eustachian tube|Insert a balloon into one Eaustachian tube and inflate it for up to one minute. The balloon is then removed.
16106502|NCT02114749|Device|a set of wearable respiration and cardiac monitoring devices|feasibility of methods for detecting physiological state changes from a set of wearable respiration and cardiac monitoring devices
16106503|NCT02114736|Procedure|Tenotomy of the proximal rectus femoris tendon|Surgical release of the proximal tendon of the rectus femoris
16106504|NCT02114736|Drug|Botulinum Toxin injection in the rectus femoris muscle|Injections of 200U of Botox in the rectus femoris muscle with a 2ml/100U dilution
16106505|NCT02114723|Device|Medical Taping Concept|"The material used is a lengthways tape bandage of cotton with elastic properties, provided with a layer of anti-allergic adhesive in one of its sides that does not contain latex. This layer of glue is applied according to a special pattern so as to allow adequate transpiration.
~The bandage is applied at the time that menstrual pain begins and is stuck to the skin for 4-5 days until menstrual pain disappears"
16106506|NCT02114710|Drug|Hydrocortisone|Hydrocortisone hemisuccinate (Roussel-Uclaf, Romainville, France), 50 mg intravenously every 6 hrs
16106507|NCT02114697|Drug|Statin therapy|Statin therapy includes rosuvastatin 20 mg administered orally, once a day, for the duration of the trial, which is 3 years. Participants may also receive a different type of statin as prescribed by their cardiologist based on clinical judgement.
16106508|NCT02114697|Behavioral|Lifestyle modification|Lifestyle modification includes a recommended exercise regimen, a healthy diet and decreasing alcohol intake for 3 years.
16106509|NCT02114684|Drug|moxifloxacin|[isoniazid (H), rifampicin (R), pyrazinamide (Z), moxifloxacin (M)]
16106510|NCT02114671|Drug|Faldaprevir high dose|capsules, oral
16106511|NCT02114671|Drug|Placebo|capsule, oral
16106512|NCT02114671|Drug|Ciprofloxacin|tablets, oral
16106513|NCT02114671|Drug|Faldaprevir low dose|capsules, oral
16106514|NCT02114658|Drug|Sorafenib (Nexavar,BAY43-9006)|Sorafenib 400 mg will be administered orally,twice daily in a 28 day cycle
16106515|NCT02114645|Drug|Leuprolide acetate|in experimentals groups,on fifth and tenth day after embryo transfer 0,5mg leuprolide acetate is given subcutaneously as luteal phase support
16106516|NCT02114645|Drug|vaginal progesterone|crinone gel is applied till fetal heart beat is detected
16106517|NCT02114645|Drug|4 mg oral estradiol valerate|estrofem is given twice a day
16106518|NCT02114632|Dietary Supplement|Eye Q|3 months of treatment with a polyunsaturated fatty acids or placebo. At 3 months a one-way treatment crossover of the placebo-group to active treatment was made so that both patient groups received active treatment for the remaining 3 month period.
16106519|NCT02114619|Drug|Low dose of I-131|We wil administer 100 micro currie of iodine per thyroid gram
16106520|NCT02114619|Drug|Intermediate dose|We will administer 150 micro currie of iodine per thyroid gram
16106521|NCT02114619|Drug|High dose|We will administer 200 micro currie of iodine per thyroid gram
16106522|NCT02114606|Device|Cytosponge™ Cell Collection Device|The Cytosponge™ Cell Collection Device (Cytosponge) is intended to collect surface cells from the esophagus. The device consists of a swallowable capsule, which dissolves in the body cavity, releasing a self-expandable sponge. The sponge is then retrieved from the esophagus using an attached cord. During the retrieval process, the sponge collects cells from the most superficial layer of the esophageal mucosa. Once removed from the body cavity, the sponge and cells are retained for investigation and/or testing. The Cytosponge™ Cell Collection Device (Cytosponge) received 510(k) clearance from the FDA on November 26, 2014 (K142695). The Cytosponge ™ Cell Collection device is a Class II product under 21 CFR 874.4710 esophagoscope (flexible or rigid) and accessories.
16106523|NCT02114593|Behavioral|Parent support program|Parent support program
16106524|NCT02114580|Other|physical training|"Participants in both the aerobic and stretching groups will carry out their activity routines 3 d/wk for 45 to 60 minutes per session for 4 months. Training will be on one on one basis, where each participant will be supervised by an experienced trainer at the participant's home.Aerobic intervention protocol: subjects will practice with stationary bicycle. Exercise intensity will be monitored through wireless HR monitor. Participants will be also monitored for the intensity of their workouts by the Borg's Rating of Perceived Exertion and the talk test (a subjective method for estimating of appropriate cardiorespiratory exercise intensity).
~Stretching exercise protocol: Participants in the stretching control group will carry out a prescribed routine of stretching and balance exercises."
16106525|NCT02114567|Other|PEEP titration|In both groups, PEEP was titrated and set to 0, 40%PEEPi, 80%PEEPi, and 120%PEEPi
16106526|NCT02114528|Drug|Antiarrhythmic Drug Therapy|Either one or more of the following antiarrhythmic drugs: sotalol, mexiletine, procainamide, or amiodarone.
16106527|NCT02114528|Procedure|Catheter ablation|Ventricular tachycardia catheter ablation.
16106528|NCT02114515|Behavioral|Hospital usual care|Written discharge instructions provided to patients prior to hospital discharge.
16106529|NCT02114515|Behavioral|Navigator intervention|A Patient Navigator will provide social support, literacy appropriate education, and act as a conduit between the patient and the patient's medical team
16106530|NCT02114515|Behavioral|Peer-led telephone support line|The peer-led telephone support line will provide social support, peer-to-peer coaching, and facilitate communication with the patient's medical care team.
16106531|NCT02114502|Drug|Carfilzomib|27 mg/m2 by vein on Days -7 and -6, then on Days -2 and -1
16106532|NCT02114502|Drug|SAHA|1,000 mg by mouth on Days -8 to -3.
16106533|NCT02114502|Drug|Gemcitabine|Loading dose of 75 mg/m2 followed by continuous infusion of the remaining dose of 1875 mg/m2 by vein on Days -8 and -3.
16106534|NCT02114502|Drug|Busulfan|Test dose of 32 mg/m2 by vein on Day -10 if inpatient, on Day -12 if outpatient, then AUC of 4,000 microMol.min on Days -8 to -5.
16106535|NCT02114502|Drug|Melphalan|60 mg/m2 by vein on Days -3 and -2.
16106536|NCT02114502|Procedure|Stem Cell Transplant (SCT)|Stem cell transplant on Day 0.
16106537|NCT02114502|Drug|Palifermin|60 microgram/kg by vein on Days -12 to -10 and Days 0, +1 and +2.
16106538|NCT02114502|Drug|Dexamethasone|8 mg by vein twice a day from Day -9 PM to Day -2 PM.
16106539|NCT02114502|Drug|Caphosol|30 mL oral rinse four times a day from Day -9 until discharge.
16106544|NCT02114476|Device|progestin implant|two small (2.5 mm × 43 mm) silicone rods each containing 75 mg of levonorgestrel in a polymer matrix
16106545|NCT02114476|Device|Placebo|
16106546|NCT02114463|Procedure|Local analgesic|Patient will be performed under combined lumbar plexus and sciatic nerve block with 0.33% ropivacaine.At the end of surgery,two catheters are left in the wound.One is intraarticular and the other is on the surface of articular cavity.And then a pump elastomeric infusion pump will be connected with the catheters, which runs 5mL every hours.
16106547|NCT02114463|Procedure|Intravenous analgesic|People in this group will also receive an anesthesia of combined lumbar plexus and sciatic nerve block with 0.33% ropivacaine.An intravenous electronic analgesia pump infusion of flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg will will provide postoperative pain management.The patients will received a 2 mL/h continuous basal infusion and 1 mL boluses with a lockout time of 30 min after a 5 mL Loading dose at the end of the surgery.
16106548|NCT02114463|Drug|ropivacaine|0.2% ropivacaine
16106549|NCT02114463|Drug|flurbiprofen|flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg
16106550|NCT02114450|Behavioral|Robot-assisted training with the H2 lower limb powered exoskeleton|The H2 is a powered, robotic lower limb exoskeleton with actuated hips, knees and ankles. A custom control algorithm has been implemented in this device, which allows for provision of assistance to lower limb segments during movement, dependent on user needs.
16106551|NCT02114450|Behavioral|Supervised motor practice|Supervised motor practice involves lower limb rehabilitation, primarily walking and other applicable lower limb exercises performed by participants under the guidance and supervision of a research physical therapist.
16106552|NCT02114437|Device|Closed-loop TCI|the controller in the current study measures and calculates the error(NI error),which is the difference between the set point(NI=36)and the measured NI.If the NI error is different from 0,the controller determines a new propoflo and/or remifentanil concentration.
16106553|NCT02114437|Device|Opened-loop TCI|the investigator modified the effect-site target concentrations of both drugs without minimum or maximum concentration limits to maintain NI at approximately 36 within a range of 26 to 46 to the extent possible.
16106554|NCT02114424|Device|Positional vibrator belt|Belt with vibarator to avoid sleep supine
16106555|NCT02114411|Procedure|GastroPanel test|Dyspeptic patients will be referred for the GastroPanel test, containing four biomarkers specific for the gastric mucosa: 1) Pepsinogen I (P-PGI), 2) Pepsinogen II (P-PGII), 3) Gastrin-17 (P-G-17) and 4) H. pylori antibody (P-HpAb).
16106556|NCT02114411|Procedure|Gastroscopy|Dyspeptic patients will undergo gastroscopy examination, with targeted biopsies from the antrum and corpus, following the protocol of the OLGA classification for chronic gastritis and Sydney Classification.
16106557|NCT02114398|Other|usual treatment|usual treatment
16106558|NCT02114398|Other|usual treatment + sophrology|usual treatment + sophrology
16106559|NCT02114385|Biological|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine, 0.5-mL intramuscular injection
16106560|NCT02114385|Biological|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine, 0.5-mL intramuscular injection
16106561|NCT02114359|Drug|Capecitabine/cisplatin|Capecitabine/cisplatin (XP) : cisplatin 50mg/m2 (80% dose of 60mg/2m) iv over 15min D1, capecitabine 1000mg/m2 (80% dose of 1250mg/m2) po bid D1-14, q 3wks
16106562|NCT02114359|Drug|S-1/cisplatin|S-1/cisplatin (SP) : cisplatin 50mg/m2 (80% dose of 60mg/2m) iv ov 15min D1, S-1 30mg/m2 (80% dose of 40mg/m2) po bid D1-14, q3wks
16106563|NCT02114359|Drug|Capecitabine/oxaliplatin|Capecitabine+oxaliplatin (XELOX): oxaliplatin 100mg/m2 (80% dose of 130mg/m2)iv ov 120min D1, capecitabine 800mg/m2 (80% dose of 1000mg/m2) po bid D1-14, q3wks
16106564|NCT02114359|Drug|5-fluorouracil/oxaliplatin|5-fluorouracil/oxaliplatin (FOLFOX): oxaliplatin 80mg/m2 (80% dose of 100mg/m2) iv ov 120min, leucovorin 80mg/m2 (80% dose of 100mg/m2) iv ov 120min, 5-fluorouracil 1900mg/m2 (80% dose of 2400mg/m2) iv ov 46h D1, q 2wks
16106565|NCT02114359|Drug|Capecitabine|Capecitabine : 1250mg/m2 po bid D1-14 q3wks (if Ccr <60ml/min, 1000mg/m2 po bid)
16106566|NCT02114359|Drug|S-1|S-1 : 40mg/m2 po bid D1-14 q3wks (if Ccr <60ml/min, 30mg/m2 po bid)
16106567|NCT02114359|Drug|5-fluorouracil|5-fluorouracil (FL) : leucovorin 100mg/m2 iv ov 2h, 5-fluorouracil 2400mg/m2 iv ov 46h D1, q2wks
16106568|NCT02114346|Drug|Atorvastatin|
16106569|NCT02114346|Drug|Placebo|
16106570|NCT02114346|Drug|0.9% sodium chloride|Patients with estimated glomerular filtration rate of less than 60 mL/min/1.73 m2 are hydrated with 0.9% sodium chloride for 2 hours, from 1 hour before (3 mL/kg/hour) to 1 hour after (1 mL/kg/hour) operation. Patients with left ventricular ejection fraction less than 40% or New York Heart Association functional class III-IV, are hydrated with 0.5 mL/kg/hour.
16106571|NCT02114333|Biological|Zostavax|0.65ml, subcutaneous
16106572|NCT02114333|Biological|HZ/su vaccine|0.5ml, intramuscular
16106573|NCT02114333|Biological|Placebo|0.65ml, subcutaneous
16106574|NCT02114320|Device|EUS-BD|EUS-guided hepaticogastrostomy (EUS-HG) will be performed in patients with hilar stricture or altered anatomy such as Roux-en-Y anastomosis, and EUS-guided choledochoduodenostomy (EUS-CD) will be performed in patients with mid to distal extrahepatic bile duct strictures. Because EUS-guided rendezvous technique can be attempted only in patients in whom the papilla is endoscopically accessible. Following bile duct puncture using a 19-gauge fine needle, one-step or graded tract dilatation will be performed. Then, finally we insert a partially or fully covered metallic stent.
16106575|NCT02114307|Device|REVITIVE IX|neuromuscular electrical stimulation device
16106576|NCT02114294|Other|Isolated hip strengthening|Exercise program that is carried out by subjects under supervision once a week and then performed at home 2 additional times without supervision for a total of 6 weeks. Hip strengthening group will train hip abduction, hip external rotation and hip extension.
16106577|NCT02114294|Other|Quadriceps based training|Exercise program that is carried out by subjects under supervision once a week and then performed at home 2 additional times without supervision for a total of 6 weeks. Quadriceps group will train mini-squat, straight leg raising, terminal extensions.
16106578|NCT02114294|Other|Active control|Patients receive standardised information concerning patellofemoral pain syndrome, but receive no prescribed exercise regime. They are encouraged to remain active.
16106579|NCT02114281|Other|Care|
16106580|NCT02114281|Other|Not care|
16106801|NCT02112630|Drug|P-IFN alfa 2a|P-IFN alfa 2b 0.75 mcg/kg/week
16106581|NCT02114268|Drug|MEDI8897 Intravenous|Participants received a single fixed dose of 300 mg MEDI8897 intravenous infusion on Day 1.
16106582|NCT02114268|Drug|Placebo|Participants received placebo on Day 1.
16106583|NCT02114268|Drug|MEDI8897 Intravenous|Participants received a single fixed dose of 1000 mg MEDI8897 intravenous infusion on Day 1.
16106584|NCT02114268|Drug|MEDI8897 Intravenous|Participants received a single fixed dose of 3000 mg MEDI8897 intravenous infusion on Day 1.
16106585|NCT02114268|Drug|MEDI8897 Intramuscular|Participants received a single fixed dose of 100 mg MEDI8897 intramuscular injection on Day 1.
16106586|NCT02114268|Drug|MEDI8897 Intramuscular|Participants received a single fixed dose of 300 mg MEDI8897 intramuscular injection on Day 1.
16106587|NCT02114255|Other|Placebo|Administration of 0.9% NaCl.
16106588|NCT02114255|Biological|BCG|Vaccination with the live attenuated BCG vaccine.
16106589|NCT02114242|Other|CSF, blood and urine sampling|PSP and MSA patients will receive CSF and blood sampling at two study visits (baseline and after 12 months).
16106590|NCT02114242|Other|clinical measures of disease severity and progression|Questionnaires (quality of life, motricity scales, cognitive scales, depression scales, scale of sleep quality)
16106591|NCT02114229|Drug|alisertib|Alisertib will be administered orally at 80 mg/m^2 per day for enteric coated tablet formulation and 60 mg/m^2 per day for oral solution formulation.
16106592|NCT02114229|Drug|methotrexate|Methotrexate will be given at a dose of 5 g/m^2/dose as an intravenous infusion over 24 hours on day 1 of each induction cycle except in patients ≤ 31 days of age at enrollment. These young infants will receive methotrexate at a reduced dose of 2.5g/m^2/dose.
16106593|NCT02114229|Drug|cisplatin|Cisplatin will be given intravenously (IV): 75 mg/m^2 IV infusion.
16106594|NCT02114229|Drug|carboplatin|Carboplatin may be substituted for cisplatin during induction for patients having Grade 4 ototoxicity or bi-lateral hearing loss after having prior cisplatin dose reduction. Route of administration is IV.
16106595|NCT02114229|Drug|cyclophosphamide|Cyclophosphamide will be given 1.5 g/m^2 IV infusion during induction and consolidation.
16106596|NCT02114229|Drug|etoposide|"Etoposide will be given 100 mg/m^2 IV infusion.
~In case of etoposide reactions, etoposide phosphate will be given 40 mg/kg/day."
16106597|NCT02114229|Drug|topotecan|Topotecan will be administered by intravenous infusion over 4 hours on days 1-5 of each consolidation cycle for Stratum B2 and B3 patients not receiving craniospinal irradiation. The initial dose of Topotecan will be based on patient's age with subsequent doses adjusted, if necessary, to achieve a topotecan lactone area under the curve (AUC) of 140 ± 20 ng/mL*hr.
16106598|NCT02114229|Drug|vincristine|Vincristine will be given 1 mg/m^2 IV via 25 mL normal saline (NS) mini-bag (maximum 2 mg for all patients) or administration per local institutional standards for participating sites.
16106599|NCT02114229|Procedure|Surgical resection|"For patients with localized AT/RT, gross total resection results in a significant survival benefit. Maximal resection that can be achieved without undue risk to the patient should be attempted prior to trial enrollment. Decisions about initial resectability will be at the discretion of the local neurosurgeon. In rare instances, the feasibility of completely resecting residual tumor may change as a result of induction chemotherapy; in these cases a second-look operation is encouraged if and may be performed prior to consolidation therapy."
16106600|NCT02114229|Radiation|Radiation therapy|The guidelines for this protocol were developed to maximize the curative potential of radiation therapy and minimize the risk of treatment complications for children with newly diagnosed CNS AT/RT. Focal irradiation is indicated for children < 36 months with no evidence of metastatic disease. Craniospinal irradiation is indicated for children age > 36 months.
16106601|NCT02114216|Procedure|endoscopic mucosal biopsy|endoscopic mucosal biopsy was undertaken for every participant.
16106602|NCT02114203|Drug|PDE9i|oral dose, every 12 hours for 28 days
16106603|NCT02114203|Drug|PDE9i|oral dose, every 12 hours for 28 days
16106604|NCT02114203|Drug|placebo for PDE9i|oral dose, every 12 hours for 28 days
16106605|NCT02114203|Drug|PDE9i|oral dose, every 12 hours for 28 days
16106606|NCT02114190|Behavioral|Adolescent Mindful Eating Group|Adolescents will learn mindfulness and meditation, how to be mindful when eating, mindful yoga, how to recognize hunger cures, understand emotional eating, trigger foods and how to apply mindful eating in social situations.
16106607|NCT02114190|Behavioral|Parent Integrated Group|Adolescents will receive learn same techniques as adolescents in Adolescent Mindful Eating Group. The group component of the parent intervention is designed for parents only and will be run parallel to the adolescent group. The goal of these sessions is to teach parents skills to support adolescent by developing effective parenting styles, parenting skills, strategies around eating behavior change, productive problem solving, and the role of all other family members with regard to the treatment process. The last five sessions will be dedicated to teaching a slightly reduced MEAL adult protocol to allow parents to learn mindfulness skills as it applies to their own eating behaviors and affective reactivity.
16106608|NCT02114177|Drug|Simeprevir|150 participants will receive 1 capsule of 150 mg simeprevir orally once daily for 12 weeks in Arm 1.
16106609|NCT02114177|Drug|Simeprevir|150 participants will receive 1 capsule of 150 mg simeprevir orally once daily for 8 weeks in Arm 2
16106610|NCT02114177|Drug|Sofosbuvir|150 participants will receive 1 tablet of 400 mg sofosbuvir orally once daily for 12 weeks in Arm 1.
16106611|NCT02114177|Drug|Sofosbuvir|150 participants will receive 1 tablet of 400 mg sofosbuvir orally once daily for 8 weeks in Arm 2.
16106612|NCT02114164|Device|AirSeal System|To analyze the results of patients randomized to either the AirSeal system or Standard Endopath trocar.
16106613|NCT02114164|Device|Standard Endopath|This group receives the Standard Endopath Trocar for intraoperative insufflation.
16106614|NCT02114151|Drug|Simeprevir|100 participants will receive 1 capsule of 150 mg orally once daily for 12 weeks.
16106615|NCT02114151|Drug|Sofosbuvir|100 participants will receive 1 tablet of 400 mg sofosbuvir orally once daily for 12 weeks.
16106616|NCT02114138|Procedure|pathogenesis of perioperative acute kidney injury|understand pathogenesis of perioperative acute kidney injury in elective and emergent surgery
16106617|NCT02114138|Diagnostic Test|urine collection|urine collection will be performed on both the control group and hospitalized participants
16106618|NCT02114125|Behavioral|Physical Activity|group-based physical activity
16106619|NCT02114125|Behavioral|Cognitive Training|individual-based, multi-domains cognitive training
16106620|NCT02114112|Other|NCPAP cycling|
16106621|NCT02114112|Other|NCPAP continuous|
16106622|NCT02114099|Drug|Atorvastatin|10 mg qd x1 year
16106623|NCT02114073|Drug|Cyclosporine|In study arm, ophthalmic emulsion of cyclosporine A 2% will be prescribed in postoperative phase.
16106624|NCT02114073|Drug|Betamethasone|In control arm, betamethasone eye drop will be prescribed in postoperative period.
16106625|NCT02114060|Biological|GEN-003 Vaccine (30μg of each antigen)|HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
16106626|NCT02114060|Biological|GEN-003 Vaccine (60μg of each antigen)|HSV-2 protein subunit vaccine consisting of 2 recombinant T cell antigens: internal fragment of the immediate early (IE) protein ICP and glycoprotein D
16106627|NCT02114060|Biological|Matrix-M2 Adjuvant (25μg)|Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
16106628|NCT02114060|Biological|Matrix-M2 Adjuvant (50μg)|Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
16106629|NCT02114060|Biological|Matrix-M2 Adjuvant (75μg)|Matrix-M2 is derived from fractionated Quillaja saponins, phosphatidylcholine, and cholesterol.
16106630|NCT02114060|Biological|Placebo|0.9% Normal Saline (NaCl)
16106631|NCT02114021|Drug|betamethasone gel|betamethasone gel (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.
16106632|NCT02114021|Drug|lidocaine jelly|the effect of lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.
16106633|NCT02114021|Drug|distilled water|The effect of betamethasone gel and lidocaine jelly (over tracheal tube cuff) compared with distilled water on the post intubation syndrome incidence.
16106634|NCT02114008|Other|Endoscopic examinations|Patients underwent two endoscopic examinations within two weeks. RGV was measured by aspiration of gastric contentes into a graduated cylinder after traditional fasting (at least 8 hours before the test) and after abbreviated fasting (3 hours with 200ml of water containing 25g of 12.5% maltodextrin). All patients received both oral and written information about the protocol at the outpatient clinic.
16106635|NCT02113995|Other|ACERTO protocol vs Traditional care|Three sample blood collections were performed, being one in the anesthesic induction and the others in the next 24 to 48 hours. The blood was sent to the laboratory for dosages of glucose, insulin, C-reactive protein, albumin, prealbumin, alpha 1 acid glycoprotein and interleukin 6. During the anesthesic induction we also collected blood for analize glycosylated hemoglobin.
16106636|NCT02113982|Drug|SL-401|
16106637|NCT02113969|Device|Vaginal Pessary|Pessary fitting session at recruitment, follow up at 1 week, then monthly to complete 1 year follow up. QoL, symptoms and sexual function Surveys will be conducted at recruitment, 6 and 12 month. The absence of bacterial vaginosis (through study of vaginal discharge and pH) will be checked prior to positioning pessary and then each control. At the end of follow up period the success related variables will be determine with a statistical model. This information will be analyzed by an expert panel aiming to identify relevant clinical variables not included. This panel will generate a Standardized Management Protocol for symptomatic pelvic organ prolapse using vaginal pessaries.
16106638|NCT02113956|Behavioral|Guy2Guy (G2G)|"G2G is a text messaging-based healthy sexuality and HIV prevention program specifically for 14-18 year old GBQ adolescent males. Content is guided by the Information-Motivation-Behavioral Skills (IMB) model and focuses on: HIV information, motivations to engage in HIV preventive behavior, communication skills, behavioral skills (e.g., using a condom; HIV testing); and healthy/unhealthy relationships. Behavioral skills content is reinforced using brief online videos. The intervention is 5 weeks long. A booster is delivered 6-weeks post-intervention end and reviews the topics covered in the intervention. G2G content is tailored based upon whether one is abstinent or sexually active."
16106639|NCT02113943|Drug|Citalopram 30mg|
16106640|NCT02113930|Biological|Constitution of a biobank of frozen cells, plasma and serum samples|Depending on clinical presentation and based on previous data obtained by our group, we will investigate the immune responses against Human papilloma virus (HPV), Cryptococcus neoformans,implication of chemokines involved in lymphocyte migration (CXCR4 and CCR7 receptors) and signalisation in response to cytokines controlling LT CD4+ homeostasis (IL-7 et IL-2).
16106641|NCT02113930|Genetic|Genetic study|High rate genome wide genetic screening, investigation of mutations associated with identified primary immune deficiencies (adenosine deaminase et class II MHC)
16106642|NCT02113917|Biological|Identification of biological markers|
16106643|NCT02113904|Drug|Adalimumab|6 injections (one every 15 days during 3 months)
16106644|NCT02113891|Drug|Eculizumab|"Eculizumab induction: 900 mg IV every 7 days for 4 doses, a fifth 1200 mg dose 7 days later Eculizumab maintenance: 15 1200 mg doses every 14 days.
~(each patient will receive a total of 20 eculizumab doses during the whole treatment period from 3 month to 12 month post-transplant)."
16106645|NCT02113878|Drug|BKM120|BKM120 is a potent and highly specific oral pan-class I PI3K inhibitor.
16106646|NCT02113878|Drug|Cisplatin|Cisplatin is a chemotherapy drug
16106647|NCT02113878|Radiation|Intensity-modulated radiotherapy (IMRT)|IMRT is the medical use of ionizing radiation, generally as part of cancer treatment to control or kill malignant cells
16106648|NCT02113839|Procedure|Spirometry|Before re-breathing (if the patient not performed one 6 months in advance).
16106649|NCT02113839|Procedure|CO Exhaled breath|In current smokers of both arms to confirm that the patient has not smoked in the past three hours and to asses the smoking status (heavy, moderate, light).
16106650|NCT02113839|Procedure|P01|P01 is the negative airway pressure generated during the ﬁrst 100 ms of an occluded inspiration. It's an estimation of the neuromuscular drive to breathe.
16106651|NCT02113839|Procedure|FeNO|The measurement of fraction of exhaled nitric oxide during exacerbations of COPD is higher than normal.
16106652|NCT02113826|Drug|Pazopanib|Pazopanib 800mg qd daily for 4 weeks = 1 cycle
16106653|NCT02113813|Drug|naquotinib|oral
16106654|NCT02113813|Drug|midazolam|oral
16106655|NCT02113800|Drug|Everolimus (Afinitor®)|Formulation: 10 mg/day Route: oral (tablet)
16106656|NCT02113787|Procedure|Pharmacokinetic study|Patients who are examen pharmacokinetic study after taking Topamax or Topiramate during 7 days
16106802|NCT02112630|Drug|P-IFN alfa 2b|P-IFN alfa 2a 135 mcg/kg/week
16106657|NCT02113774|Other|antimicrobial treatment according to in-vitro susceptibility|
16106658|NCT02113748|Other|Downhill walking training|Walk on a treadmill with a negative inclination.
16106659|NCT02113748|Other|Conventional walking training|Walk on a treadmill without inclination. Possible to progress training intensity with positive inclinations
16106660|NCT02113735|Drug|H.P. Acthar® Gel (repository corticotropin injection)|
16106661|NCT02113735|Drug|Placebo|
16106662|NCT02113722|Procedure|Left cardiac sympathetic denervation|Left cardiac sympathetic denervation via a video
16106663|NCT02113722|Procedure|Standard of Care|Medical therapy
16106664|NCT02113709|Device|Occlusion therapy by Eye Patch|The good eye was occluded by a stick-on eye patch to stimulate the amblyopic eye and its neural connections to learn to see again.
16106665|NCT02113709|Device|Occlusion therapy|To see how much improvement in visual acuity occurs by full-time occlusion therapy.
16106666|NCT02113696|Dietary Supplement|Omega 3 intake, morbid obesity|Individuals of both sexes with ages between 18 and 65 years took 3g of omega 3, and 1.8g eicosapentaenoic acid (EPA) and 1.2g docosahexanoic acid (DHA) for 8 weeks.
16106667|NCT02113696|Dietary Supplement|Placebo Capsules|They received gelatin (colorless) capsules. A nutritional evaluation was performed, a 24-h recordatory was applied to verify macro and micronutrients intake, biochemical evaluation before and after the intervention. Macro and micronutrients were calculated using the Avanutri 2.0 system. Clinical history was verified through a questionnaire previously filled out by a physician.
16106668|NCT02113670|Other|SUI 1|instillation of 50ml of air into the urinary bladder before the urodynamic test
16106669|NCT02113657|Drug|Ipilimumab|3 mg/kg by vein once every 3 weeks for a total of 4 doses.
16106670|NCT02113644|Other|Lifestyle intervention|
16106671|NCT02113631|Drug|Telaprevir|
16106672|NCT02113631|Drug|Boceprevir|
16106673|NCT02113631|Drug|Peg-IFN|Administration 45-180mcg in 0.5 ml solution s.c. weekly for 24-48 weeks
16106674|NCT02113631|Drug|Ribavirin|Administration: 200 mg capsules; 800 mg-1200 mg daily for 24-48 weeks
16106675|NCT02113618|Behavioral|Cogmed training|Cogmed® working memory training session consists 90 trials and lasts for approximately 30 minutes per day, 5 days a week and during a total training period of 5 weeks (i.e. total training time approximately 12,5 hours). In order to complete the study each subject must complete 20 - 25 training sessions within maximum 6 weeks. The program adjusts the difficulty of the different tasks trial-by-trial, which allows for each subject to train at a level adjusted to his or her current Working memory capacity
16106676|NCT02113618|Behavioral|Standard Training|Standard training session in an online training and also consists 90 trials and lasts for approximately 30 minutes per day, 5 days a week and during a total training period of 5 weeks. In order to complete the study each subject must complete 20 - 25 training sessions within maximum 6 weeks. The program does not increase in difficultly level
16106677|NCT02113605|Other|Cognitive behavior therapy|Exposure-based cognitive behavior therapy in a 10 week face-to-face treatment
16106678|NCT02113592|Behavioral|Interdisciplinary pain program|Interdisciplinary pain program, which includes behavioral health, nurse case management, physical therapy, and pharmacy embedded in primary care.
16106679|NCT02113579|Device|Experimental Mouth Rinse 12027-033|After brushing for at least one-minute using at least one-inch strip of toothpaste, rinse with water and then rinse 60 seconds with 10mL of mouth rinse, twice daily.
16106680|NCT02113579|Other|Placebo Mouth Rinse|After brushing for at least one-minute using at least one-inch strip of toothpaste, rinse with water and then rinse 60 seconds with 10mL of mouth rinse, twice daily.
16106681|NCT02113566|Drug|Acetaminophen 1000mg|Subjects who require rescue medication between hours 4 and 6 will be allowed to take Dose 2 of the study medication. If the subject chooses to take a rescue analgesic (acetaminophen 1000mg), they will be considered a treatment failure. This intervention will be use for the placebo and Ibuprofen arm.
16106682|NCT02113553|Drug|Triptorelin|Triptorelin administered once every 28 days in addition to chemotherapy
16106683|NCT02113540|Drug|Atorvastatin|
16106684|NCT02113449|Drug|Carbon Dioxide|Nasal administration of carbon dioxide (CO2) through the delivery device for 10 seconds
16106685|NCT02113436|Drug|FP/ SLM HFA MDI 50/25 mcg|Metered-dose aerosol product containing 50 mcg of fluticasone propionate and 25 mcg of salmeterol per inhalation
16106686|NCT02113436|Drug|FP HFA MDI 50 mcg|Metered-dose aerosol product containing 50 mcg of fluticasone propionate per inhalation
16106687|NCT02113423|Radiation|3D-CRT, IMRT, BT, BT combined 3D-CRT or IMRT|3D - CRT（3D-Conformal Radiotherapy）: CTV-P 50-60Gy(2 Gy or 1.8 Gy per daily fraction, 5 days per week) IMRT（Intensity Modulated Radiotherapy）: GTV-P 50-60 Gy(2 Gy or 1.8 Gy per daily fraction, 5 days per week) BT(Brachytherapy): 2.5Gy BID*10F one week interval BT combined 3D - CRT or IMRT: First,GTV-P 40Gy(2 Gy or 1.8 Gy per daily fraction, 5 days per week);Then, 2.5Gy BID*2F
16106688|NCT02113410|Behavioral|Sit 'N' Fit Chair Yoga (SNFCY)|Experimental: Sit 'N' Fit Chair Yoga - a twice-weekly, 8-week yoga program of 45-minute sessions. Active Comparator: Health Education Program (HEP), a twice-weekly, 8-week program of 45-minute sessions
16106689|NCT02113410|Behavioral|Health Education Program (HEP)|Willing and eligible subjects randomized to the Health Education Program (HEP) attended twice-weekly 45-minute health education sessions for 8 weeks, for a total of 16 sessions.
16106690|NCT02113397|Drug|TOBI™ Podhaler™ 112 mg inhaled twice daily|
16106691|NCT02113397|Drug|Colistimethate 75 mg inhaled two times daily|
16106692|NCT02113384|Other|Observational study.|Biobanking of tissue (tumor biopsy, peritoneal lavage, blood specimen) from patients with locally advanced rectum cancer undergoing surgical resection of the primary tumor at the Norwegian Radium Hospital.
16106693|NCT02113371|Behavioral|Intervention|
16106694|NCT02113358|Drug|Intravenous colloid bolus with Voluven|
16106695|NCT02113345|Behavioral|Metamemory Cognitive Intervention|Metamemory Cognitive Intervention
16106696|NCT02113332|Drug|Liraglutide|
16106697|NCT02113332|Drug|Placebo|
16106698|NCT02113319|Drug|dasatinib|dasatinib 50 mg and 20 mg During one year
16106699|NCT02113306|Device|t-VNS|The device that will be used is approved for systematic use by those with epilepsy and depression in the European Union. It has been used in studies of acute stimulation with healthy participants with no significant changes in heart rate or breathing (Kraus et al., 2007; Busch et al., 2013).
16106700|NCT02113306|Device|sham stimulation|electrodes will be put upside down
16106701|NCT02113293|Drug|CyclASol®|Cyclosporine A Solution
16106702|NCT02113293|Drug|Placebo (vehicle)|Vehicle Solution
16106703|NCT02113280|Procedure|Arthroscopy|Patients to receive knee arthroscopy and meniscal debridement
16106704|NCT02113280|Procedure|Physiotherapy|Outpatient standardised physiotherapy regime with focus on exercise therapy
16106705|NCT02113267|Drug|Mometasone furoate|4 spray doses à 50 micrograms by mouth to be swallowed 4 times daily after meals with no eating or drinking allowed 30 minutes after intake. Duration of treatment is 8 weeks.
16106706|NCT02113267|Drug|Placebo|4 spray doses à 50 micrograms by mouth to be swallowed 4 times daily after meals (9) with no eating or drinking allowed 30 minutes after intake. Duration of treatment is 8 weeks.
16106707|NCT02113254|Other|Corn zeaxanthin|The treatment will consist in a daily consumption of a box of 125g of corn with strong zeaxanthin content during 10 weeks. This corresponds to a daily contribution of at least 1,2 mg of lutein and 2,2 mg de zeaxanthin
16106708|NCT02113241|Drug|Dapagliflozin|Dapagliflozin capsules, 10 mg, one per day before breakfast during 90 days.
16106709|NCT02113241|Drug|Placebo|Placebo capsules, 10 mg, one per day before breakfast during 90 days.
16106710|NCT02113215|Procedure|Stable Isotope Infusion|9-hour infusion of stable isotope tracers
16106711|NCT02113202|Drug|Bevacizumab-IRDye800CW|Intravenous administration of a 4.5 mg, 10 mg or 25 mg of Bevacizumab-IRDye800CW 3 days prior to the fluorescence endoscopy procedure.
16106712|NCT02113202|Device|Near infrared fluorescence endoscopy platform|A flexible fiber-bundle is attached with its proximal end to a camera which can detect near infrared fluorescent light. The distal end is inserted into the working channel of a clinical video endoscope, which is used for the surveillance endoscopy procedure.
16106713|NCT02113189|Other|Walking program with ankle brace|Walking program will include instructions on walking activities at home such as time of walking. Walking will be done with the bilateral ankle braces on.
16106714|NCT02113189|Other|Individualized walking program|Walking program will include instructions on walking activities at home such as time of walking
16106715|NCT02113189|Other|Walking program with custom braces.|Walking program will include instructions on walking activities at home such as time of walking. Walking will be done with custom-fabricated ankle braces on.
16106716|NCT02113176|Drug|Minocycline|
16106717|NCT02113163|Drug|Metformin Eicosapentaenoate|
16106718|NCT02113163|Drug|Metformin HCl and Vascepa|
16106719|NCT02113150|Drug|remifentanil|renal function
16106720|NCT02113150|Drug|Ketamine|renal function
16106721|NCT02113137|Drug|group 1: drug: chlorine dioxide|"First, each group practiced tooth brushing only for one week. After that each group was requested to do the following procedures.
~group 1 - additional use of 12ml chlorine dioxide (ClO2) mouthwash two times per day, for three consecutive weeks besides tooth brushing.
~At last, each group practiced all three methods of tooth brushing, tongue cleaning, mouth washing."
16106722|NCT02113137|Device|group 2: device: small tooth brush for tongue cleaning|"First, each group practiced tooth brushing only for one week. After that each group was requested to do the following procedures.
~group 2 - additional practice of tongue cleaning by a small tooth brush two times per day, for three consecutive weeks besides tooth brushing.
~At last, each group practiced all three methods of tooth brushing, tongue cleaning, mouth washing."
16106723|NCT02113111|Behavioral|Fasting|Fasting therapy was adapted from Buchinger, including a fasting period of 7 days. After 2 prefasting days with 800kcal per day from vegetables and rice/potatoes, fasting starts with the ingestion of an oral laxative. During fasting patients receive small quantities of juice and herbal teas, and a vegetable broth for lunch, altogether no more than 350kcal per day. At the end, fasting is broken by an apple or cooked potato, and for the following 3 days nutrition returns to normocaloric diet.
16106724|NCT02113098|Other|Treadmill, ankle load|The experimental group will perform gait training on a treadmill (Gait Trainer 2®) with added load to the ankle of the non-paretic lower limb, plus physical therapy correction for restore gait symmetry. The intervention will last 30 minutes, in nine sessions for two weeks
16106725|NCT02113098|Other|Treadmill|The control group (active comparator) will perform gait training on a treadmill (Gait Trainer 2®) with physical therapy correction for restore gait symmetry. The intervention will last 30 minutes, in nine sessions for two weeks
16106726|NCT02113085|Behavioral|Self-determination enhancement|Self-determination enhancement through individual coaching and peer mentoring workshops
16106727|NCT02113072|Drug|Beclomethasone|The wheezing infants will be using the inhaled corticosteroid beclomethasone 50mcg - 02 jets per day (100mcg/dia).
16106728|NCT02113072|Drug|Probiotics|Lyophilized form, each sachet containing 1 g of the probiotic, to be used in addition to milk, juice or yoghurt in the first morning meal once daily for 60 days.
16106729|NCT02113072|Drug|Placebo|The placebo will be supplied in the same way with the same organoleptic characteristics of formula with probiotics, 1 g sachet for 60 days, in the juice, milk or yoghurt.
16106730|NCT02113046|Procedure|pancreatico-jejunal anastomosis|
16106731|NCT02113046|Procedure|traditional anastomosis|
16106732|NCT02113033|Device|Equilia® Vagal Nerve Stimulation|Vagal Nerve Stimulation synchronized with cardiac activity
16106733|NCT02113020|Drug|TAK-233|Oral administration of TAK-233
16106734|NCT02113020|Drug|Placebo|Oral admininstration of Placebo
16106735|NCT02113007|Drug|Rituximab plus Temozolomide|Treatment cycles will be repeated every 14 days (2 weeks) for the lead-in portion. If no prohibitive toxicities are observed in the first 6 patients during the first 2 treatment cycles, the study will continue enrolling patients. Treatment cycles for the Phase II portion will be repeated every 14 days (2 weeks) for a total of 12 cycles.
16106736|NCT02112994|Drug|Sebelipase Alfa|IV infusion of sebelipase alfa
16106737|NCT02112981|Device|Sirolimus Eluting Coronary Stent|BioMimeTM Sirolimus Eluting Stent (CE Marked) has cobalt chromium NexGenTM platform (CE Marked) with Tamarin BlueTM balloon Delivery System (CE marked and with FDA clearance under 510k). Stent is coated with combination of Sirolimus drug and Biodegradable PLLA and PDLG polymers.
16106738|NCT02112981|Device|Everolimus-eluting Coronary stent|Xience V/Xience Xpedition/Xience Prime stent is MULTI-LINK MINI VISION or MULTI-LINK VISION platform Cobalt chromium stent with Everolimus (active ingredient) embedded in a non-erodible polymer (inactive ingredient).
16106739|NCT02112968|Procedure|Proscan|One device (500 Hz Excimer Laser) with three interventions (Proscan, Zyoptix and Supracor as algorithms)
16106740|NCT02112968|Procedure|Zyoptix|One device (500 Hz Excimer Laser) with three interventions (Proscan, Zyoptix and Supracor as algorithms)
16106741|NCT02112968|Procedure|Supracor|One device (500 Hz Excimer Laser) with three interventions (Proscan, Zyoptix and Supracor as algorithms)
16106742|NCT02112955|Behavioral|Stroke self-management program|A nurse-led community-based self-efficacy enhancing stroke self-management program.
16106743|NCT02112955|Behavioral|Usual care|Usual care such as hospital-based or community-based health education or services.
16106744|NCT02112942|Drug|IDX21459|
16106745|NCT02112942|Drug|Matching Placebo|
16106746|NCT02112929|Drug|Hyperpolarized xenon|Inhalation of up to one litre of polarized xenon gas, up to four inhalations per day are permitted.
16106747|NCT02112916|Drug|Bortezomib|Given IV
16106748|NCT02112916|Drug|Cyclophosphamide|Given IV
16106749|NCT02112916|Drug|Cytarabine|Given IT, IV, or SC
16106750|NCT02112916|Drug|Daunorubicin|Given IV
16106751|NCT02112916|Drug|Daunorubicin Hydrochloride|Given IV
16106752|NCT02112916|Drug|Dexamethasone|Given PO or IV
16106753|NCT02112916|Drug|Doxorubicin|Given IV
16106754|NCT02112916|Drug|Doxorubicin Hydrochloride|Given IV
16106755|NCT02112916|Drug|Etoposide|Given IV
16106756|NCT02112916|Drug|Hydrocortisone Sodium Succinate|Given IT
16106757|NCT02112916|Drug|Ifosfamide|Given IV
16106758|NCT02112916|Drug|Leucovorin Calcium|Given PO or IV
16106759|NCT02112916|Drug|Mercaptopurine|Give PO
16106760|NCT02112916|Drug|Methotrexate|Given IT, IV, or PO
16106761|NCT02112916|Drug|Pegaspargase|Given IV
16106762|NCT02112916|Radiation|Radiation Therapy|Undergo radiation therapy
16106763|NCT02112916|Drug|Thioguanine|Given PO
16106764|NCT02112916|Drug|Vincristine|Given IV
16106765|NCT02112916|Drug|Vincristine Sulfate|Given IV
16106766|NCT02112903|Drug|Encapsulated vortioxetine IR tablet, 20 mg|
16106767|NCT02112903|Drug|Vortioxetine MR capsule 20 mg (pH 5.5)|
16106768|NCT02112903|Drug|Vortioxetine MR capsule 20 mg (pH 6.0)|
16106769|NCT02112903|Drug|Vortioxetine MR capsule 20 mg (pH 7.0)|
16106770|NCT02112890|Other|Data collection|Data of the selected subjects (through structured questionnaires and interviews) and stored serum samples obtained from the ENSANUT 2012. A subset database will be designed by the NIPH for the purpose of this study. Extracted data and laboratory results of the selected subjects will be captured in the study database.
16106771|NCT02112877|Device|Veniti Vici™ Venous Stent System|
16106772|NCT02112864|Drug|Dexamethasone|10 mg (2.5 ml)
16106773|NCT02112864|Drug|Normal Saline|2.5 mL normal saline
16106774|NCT02112851|Other|Orange flavored beverage|Intervention involves consumption of one beverage of 240ml following baseline measurements
16106775|NCT02112838|Drug|Fostamatinib 150 mg|Fostamatinib 150 milligram (mg) tablet twice daily by mouth, over the course of 24 weeks
16106776|NCT02112838|Drug|Fostamatinib 100 mg|Fostamatinib 100 mg tablet twice daily by mouth, over the course of 24 weeks
16106777|NCT02112838|Drug|Placebo|Placebo tablet twice daily by mouth, over the course of 24 weeks
16106778|NCT02112825|Behavioral|Exercise|Blended supervised-home based walking exercise 3-4 times per week for 30-45 minutes
16106779|NCT02112812|Drug|Eradication therapy for H.pylori infection|Patients who were positive for H.pylori infection received an eradication therapy consisting of oral esomeprazole 40 md daily, oral clarithromycin 500mg bd and oral amoxicillin 1000mg bd for 14 days.
16106780|NCT02112812|Drug|Eradication of Helcobacter Pylori|Patients who are positive on urea breath test are given eradication therapy for 14 days, Eradication therapy includes esomeprazole 40mg daily, clarithromycin 500mg bd, amoxicillin 1g bd
16106781|NCT02112812|Drug|Eradication therapy for Helicobacter pylori|
16106782|NCT02112799|Drug|NVR 3-778|
16106783|NCT02112799|Drug|Placebo for NVR 3-778|Sugar pill manufactured to mimic the NVR 3-778 capsule
16106784|NCT02112799|Drug|Pegasys|
16106785|NCT02112786|Device|Intermittent or Continuous Setting RestorePrime Implanted Impulse Generator|This is a routine procedure already performed, we are simply changing a post surgical setting to observe for improvement.
16106786|NCT02112760|Other|specific stabilization exercise|The specific stabilization exercise refers to an exercise that targets the deep trunk muscle, including the multifidus and transversus abdominis with ultrasound feedback.
16106787|NCT02112747|Other|Patient Navigator|Patients are randomized to receive the assistance of a patient navigator to understand, obtain assistance with following the screening recommendations of the personal prescription given to them by the website survey.
16106788|NCT02112734|Drug|Vitamin D|400 IU/daily until age 12 months
16106789|NCT02112734|Drug|placebo|identical placebo daily
16106790|NCT02112721|Dietary Supplement|Vitamin D|
16106791|NCT02112721|Dietary Supplement|Placebo|
16106792|NCT02112708|Other|Rational-Emotive-Behavioral Therapy|A social worker held eight 30 minutes sessions fortnightly. First session is informative about the type of treatment to be performed. The next sessions work events, thoughts and feelings with the goal of changing the dysfunctional thoughts by other more rational ones, measured by scales.
16106793|NCT02112708|Other|Control Group usual care|In the control group the depression is treated as usual with the conventional treatment.
16106794|NCT02112695|Other|[11C]diprenorphine|3 micrograms [11C]diprenorphine - intravenous use - 1 time
16106795|NCT02112682|Procedure|Completion axillary treatment|Completion axillary treatment according to the Dutch breast cancer guideline
16106796|NCT02112669|Device|VasQ|
16106797|NCT02112656|Drug|ThermoDox|Thermally Sensitive Liposomal Doxorubicin 50 mg/m2 Single 30 minute intravenous infusion
16106798|NCT02112656|Drug|Dummy infusion|Sodium Chloride 0.9% or 5% Dextrose (D5W), Single 30 minute intravenous infusion
16106799|NCT02112643|Drug|Sodium selenate|A 100 microgram pill will be orally administered twice a day for 6 months.
16106800|NCT02112643|Dietary Supplement|Sugar pill|The placebo pill will be constructed to look exactly like the selenium pill, but will have no active ingredients. This will be orally administered for 6 months.
16106803|NCT02112630|Drug|Ribavirin|200 mg PO once daily or 200 mg PO three times a week
16106804|NCT02112630|Drug|Boceprevir|800 mg PO three times daily starting at week 4
16106805|NCT02112617|Radiation|Proton Beam Radiation Therapy|Proton radiation will be delivered daily for 3-4 weeks, depending on the dose prescribed by study doctor. Treatment is delivered (Monday - Friday) for 5 days (no weekends or holidays). Each treatment the participant will lie on a table for 30-45 minutes.
16106806|NCT02112604|Device|Ventilator|Mechanical ventilator used to replace or assist spontaneous breathing.
16106807|NCT02112604|Device|Alice PDx|Alice PDx is a polysomnography monitor used to study stages of sleep and detect sleep-disordered breathing. The device monitors PO2, airflow, EEG, EOG and abdominal wall movements to detect sleep apnea.
16106808|NCT02112604|Other|Pulmonary function test|The pulmonary function tests are used to study upper airway patency.
16106809|NCT02112604|Other|Muscle strength tests|MRC score (0-60) is a clinical assessment of muscle power on abduction of the arm, flexion of the forearm, extension of the wrist, flexion of the leg, extension of the knee and dorsal flexion of the foot with the score of (0-5) on each measurement
16106810|NCT02112604|Other|Grip strength measurement|Grip strength has been shown to be an accurate means of assessing muscle function in the critically ill. Muscle weakness may have an impact on upper airway patency.
16106811|NCT02112604|Drug|Sedatives and muscle relaxants given in the ICU|Patients in the ICU are administered sedatives, anesthetics, opiods, anti-pyschotics and neuromuscular blocking agents as part of routine care. We hypothesize that the use of these drugs is associated with sleep-disordered breathing following extubation. We will collect the drug doses from the patient's chart.
16106812|NCT02112591|Procedure|transobturator subtrigonal tape S-TOT|Minimally invasive surgery for placement of suburethral polypropylene tape (TOT), which is widely used around the world and considered the standard of treatment at present, has very limited efficacy when considering the correction of SUI without affecting normal micturition. There is evidence that the placement of autologous fascia tape in subtrigonal position has higher efficacy. Thus, the subtrigonal placement of polypropylene mesh tape through minimally invasive procedures could have higher efficacy.
16106813|NCT02112591|Procedure|Transobturator suburethral tape (TOT)|Minimally invasive procedures in which needles are inserted via transobturator approach for the placement in mid-urethral position of polypropylene tape that is 1.5cm wide for the treatment of SUI
16106814|NCT02112578|Drug|Meclizine|25 mg, 3 times per day up to 30 days
16106815|NCT02112578|Drug|Dimenhydrinate|50 mg, 3 times per day up to 30 days
16106816|NCT02112565|Drug|RNR inhibitor COH29|Given PO
16106817|NCT02112565|Other|laboratory biomarker analysis|Correlative studies
16106818|NCT02112565|Other|pharmacological study|Correlative studies
16106819|NCT02112552|Drug|Paclitaxel|Given IV
16106820|NCT02112552|Drug|Carboplatin|Given IP
16106821|NCT02112552|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo 3D conformal radiation therapy
16106822|NCT02112552|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16106823|NCT02112552|Other|Quality-of-Life Assessment|Ancillary studies
16106824|NCT02112552|Other|Laboratory Biomarker Analysis|Correlative studies
16106825|NCT02112539|Other|platelet aggregation measurement|
16106826|NCT02112526|Drug|Acalabrutinib|
16106827|NCT02112500|Biological|Mesenchymal Stem Cell|Mesenchymal stem cells will be intravenously infused. Mesenchymal stem cells will be cultured and extracted from the bone marrow of the patients.
16106828|NCT02112487|Drug|Macitentan|10 mg once daily
16106829|NCT02112474|Device|Spinal Cord Stimulation|Crossover design whereby subjects will undergo Spinal Cord Stimulation in two arms: low frequency stimulation and high frequency stimulation
16106830|NCT02112474|Device|Group 1|9 days of spinal cord stimulation at 30 Hertz and perceptible paraesthesias
16106831|NCT02112474|Device|Group 2|9 days of spinal cord stimulation with 1000 Hertz and sub-perception paraesthesias
16106832|NCT02112461|Behavioral|SCP-Hospice Alert|The intervention in Project 1 SCP utilizes a multi-faceted system. The SCP-Hospice symptom management model will include several features: 1) a computer-based telecommunication system to monitor symptoms as perceived and reported by the family caregiver; 2) tailored care management messages that SCP provides directly to the caregivers to promote care management based on the individualized patient symptom profile and caregiver distress; and 3) an automated alerting function that notifies the hospice nurse of unrelieved symptoms that have exceeded a pre-set threshold.
16106833|NCT02112448|Drug|continuous infusion|Continuous morphine/midazolam and 'as needed' doses. Will receive scheduled acetaminophen and ketorolac.
16106834|NCT02112448|Drug|as needed dosing|morphine and midazolam as needed. Will receive scheduled acetaminophen and ketorolac..
16106835|NCT02112448|Drug|Acetaminophen|Acetaminophen will be given every 4 hours for a total of 24 hours.
16106836|NCT02112448|Drug|ketorolac|Ketorolac 0.5 mg/kg will be given every six hours to all subjects in the study.
16106837|NCT02112435|Device|Somnyx ®|Active mandibular advancement splint
16106838|NCT02112435|Device|Narval ORM ® or SomnoDent ®|Mandibular advancement splint
16106839|NCT02112422|Drug|Control|The control group will receive 0.15 mg/kg of intravenous dexamethasone (maximum dose 20mg) in 100ml normal saline immediately prior to skin incision.
16106840|NCT02112422|Drug|Intervention|Patients in the intervention group will receive 0.15 mg/kg of intravenous dexamethasone (maximum dose 20mg) in 100ml normal saline 45-60 minutes prior to the OR.
16106841|NCT02112409|Procedure|cell salvage technique|blood from the surgical field is collected, anti-coagulated, filtered, centrifuged, washed and re-suspended in saline to produce autologous blood with a resultant haematocrit of 50-80% for transfusion back to the patient using specific cell saver device
16106842|NCT02112409|Procedure|acute normovolemic hemodilution|Removal of 500ml whole blood from the patient after induction of anesthesia, with restoration of blood volume with acellular fluid using equivolume of 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven) to maintain isovolemia
16106903|NCT02112097|Drug|PASI 75 n(%) subdermally at Week 36|PASI 75 n(%) as Efficacy of Enbrel subdermally at Week 36, in terms of the proportion of patients who achieved a reduction in score of at least 75% from baseline by the PASI.
16107053|NCT02111044|Drug|Octreotide|octreotide 100 mcg sc t.i.d. for 4 weeks
16106843|NCT02112396|Behavioral|Community Reinforcement and Family Training|The Intervention is based on the CRAFT literature and includes Building and sustaining motivation of CSOs, functional analysis of problem behaviors, domestic violence precautions (if mandatory), improving communication skills of CSOs, use of negative consequences of drinking behavior, positive reinforcement of clean and sober behavior, strategies to enrich CSOs lives, and strategies for inviting the addicted individual to enter treatment.
16106844|NCT02112383|Behavioral|Cognitive behavior group therapy|For participants in the group intervention condition, the modules from a self-help treatment for procrastination will be delivered at four consecutive three-hour sessions at the Student Health Centre at Karolinska Institutet, with approximately two modules given at each session. The sessions will be spaced two weeks apart, during which participants are instructed to complete assignments related to the modules that were in focus of the previous session, e.g., goal-setting, time management, and behavioral experiments, which they are advised to present and discuss with the other participants.
16106845|NCT02112383|Behavioral|Internet-based cognitive behavior therapy|For participants in the Internet-based condition, the modules from a self-help treatment for procrastination will be distributed weekly during the treatment period, with one module given each week, i.e., ten weeks. In comparison to the group condition, participants will not receive a therapist contact or attend any sessions. In addition, the participants are expected to complete both the reading material and the assignments that are included in each module.
16106846|NCT02112370|Drug|Ropivacaine with epinephrine injection|1 mg/mL 1cc epinephrine is diluted in 100cc normal saline and then 7.5 mg/mL 30cc ropivacaine is diluted in the same normal saline. The mixture is injected into the subcutaneous layer for the initial flap dissection for the experiment group.
16106847|NCT02112370|Other|Placebo|100cc normal saline is injected into the subcutaneous layer for the initial flap dissection for the placebo group.
16106848|NCT02112344|Radiation|IMRT|
16106849|NCT02112331|Other|Raw human milk|
16106850|NCT02112331|Other|Pasteurized human milk|
16106851|NCT02112331|Other|Pasteurized-homogenized human milk|
16106852|NCT02112331|Other|Gastric samples|
16106853|NCT02112305|Drug|isotonic magnesium sulphate|2.5 ml of isotonic magnesium sulphate (150 mg, 245 mmol/L) NB on three occasional at 20 minutes interval
16106854|NCT02112305|Drug|50% magnesium sulphate|magnesium sulphate 50mg/kg/dose intravenous drip in 20 minutes for one dose
16106855|NCT02112292|Drug|tetrahydrocannabinol|
16106856|NCT02112292|Drug|cannabidiol|
16106857|NCT02112292|Drug|Placebo|
16106858|NCT02112279|Biological|Donor microbiota applied via colonoscopy.|"B. Preparation of donor sample 1. Instillation via Colonoscopy
~1. Stool mixture is administered into the terminal ileum and cecum through the biopsy channel of a colonoscope while the patient is sedated.
~Administer 300-700 ml of slurry through biopsy channel of colonoscope with a piston syringe."
16106859|NCT02112266|Other|Mail support|between post treatment and follow up two groups: one with unspecific mail support every 2 weeks one without
16106860|NCT02112266|Other|no mail support|follow-up without mail support
16106861|NCT02112253|Device|Deep brain stimulator ventral electrode up to 2 mA|
16106862|NCT02112253|Device|Deep brain stimulator ventral electrode up to 3 mA|
16106863|NCT02112253|Device|Deep brain stimulator dorsal electrode up to 2 mA|
16106864|NCT02112253|Device|Deep brain stimulator dorsal electrode up to 3 mA|
16106865|NCT02112253|Device|Deep brain stimulator empirical programming|
16106866|NCT02112240|Other|Intraoperative Mobile Gamma Camera imaging|Intraoperative images will be taken with a unique mobile gamma camera to identify sentinel lymph nodes in the rectum.
16106867|NCT02112240|Drug|Endoscopic injection of 99mTc-sulfur colloid|Radiotracer injection around the rectal tumor for pre- and intra-operative imaging.
16106868|NCT02112240|Other|Endoscopic injections of Spot|Dye injection for tattooing rectal tumor prior to surgical resection.
16106869|NCT02112240|Procedure|Preoperative flexible sigmoidoscopy|Flexible sigmoidoscopy prior to surgery to facilitate endoscopic injections of radiotracer and dye.
16106870|NCT02112240|Radiation|SPECT/CT|Preoperative imaging to identify lymph nodes in rectum.
16106871|NCT02112227|Other|PACT-HF Model|PACT-HF Model includes the following 1) comprehensive patient assessment 2) self-care education 3) patient-centered discharge summary 4) early follow up with FP 5) referral of high-risk patients to regional multidisciplinary HF clinic and to nurse-led home care
16106872|NCT02112214|Drug|10-day bismuth-based quadruple therapy|Bismuth 300 mg (4 times a day), lansoprazole 30 mg (twice a day), metronidazole 500 mg (3 times a day), and tetracycline 500 mg (4 times a day) for 10 days
16106873|NCT02112214|Other|Placebo|Placebo for bismuth-based quadruple therapy
16106874|NCT02112201|Behavioral|Integrated intervention for parents and adolescent girls|The intervention will consist of individually administered preventive curriculum for adolescent girls involved in the juvenile justice system that integrally addresses delinquency, drug abuse, and trauma exposure, along with group-based training and support for parents.
16106875|NCT02112188|Behavioral|In-depth Patient Interviews|
16106876|NCT02112188|Behavioral|Adaptation of IMCP for Chinese Immigrant Cancer Patients|
16106877|NCT02112188|Behavioral|Individual Meaning-Centered Psychotherapy for Chinese (IMCP-Ch) (For Phase 3)|The six sessions will be delivered every or every other week over a span of 6-16 weeks, depending on participant and interventionist availability. Sessions may also be delivered within 2 weeks to accommodate schedules. Sessions will take place via MSK-approved videoconferencing platforms (e.g. Zoom) or by telephone, depending on participant preference
16106878|NCT02112175|Drug|Lenalidomide|
16106879|NCT02112162|Radiation|fludeoxyglucose F 18|Undergo FDG PET/MRI
16106880|NCT02112162|Device|positron emission tomography|Undergo FDG PET/MRI
16106881|NCT02112162|Device|magnetic resonance imaging|Undergo FDG PET/MRI
16106882|NCT02112162|Other|laboratory biomarker analysis|Correlative studies
16106904|NCT02112097|Drug|Adverse Reactions of Enbrel subcutaneously|Adverse Reactions of Enbrel subcutaneously at Week 36, in number of Injection site reactions, Heart failure, Allergic Reactions, Blood problems/low blood counts, Nervous system, Infections, Malignancies, Immunogenicity, and Autoantibodies.
16106969|NCT02111655|Procedure|ktv test|Weekly ktv measurement using biosensors. In patients who have been dialyzed in monitors with no biosensors, ktv will be measured monthly using monocompartimental Daugirdas equation
16106883|NCT02112149|Behavioral|LIVESTRONG|The LIVESTRONG at the YMCA is a twelve-week, small group (< 16 participants) program designed for adult cancer survivors. YMCA fitness instructors work with each participant to fit the program to their individual needs. The instructors are trained in the elements of cancer, post rehabilitation exercise and supportive cancer care. There are two YMCA fitness instructors overseeing each exercise session. Each session is 90 min in duration, twice per week, for 12-wks (total of 24 sessions). Each session begins with a warm-up, then aerobic exercise (e.g., treadmill) and resistance training exercises, followed by a cool-down period, and follows the recommendations of the American College of Sports Medicine.
16106884|NCT02112136|Other|Blood Collection|Phenotype and Genotype Analysis, Biological Analysis
16106885|NCT02112123|Drug|Icariin|
16106886|NCT02112123|Dietary Supplement|Matching placebo|
16106887|NCT02112110|Drug|BMS-791325|
16106888|NCT02112110|Drug|[13C]-BMS-791325|
16106889|NCT02112097|Drug|Gadolinium|"For Left Upper Arm Total Persistent % subdermally, on MRI at 6 hrs, 12 hrs, and 24 hrs.
~Gadolinium Magnevist® (gadopentetate dimeglumine)
~.1cc/ diluted with .9cc normal saline subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients."
16106890|NCT02112097|Drug|Gadolinium|"For Left Upper Arm Total Persistent % subcutaneously, on MRI at 6 hrs, 12 hrs, and 24 hrs.
~Gadolinium Magnevist® (gadopentetate dimeglumine)
~.1cc/ diluted with .9cc normal saline subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients."
16106891|NCT02112097|Drug|Gadolinium|For Left Upper Arm Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI.
16106892|NCT02112097|Drug|Efficacy of Enbrel subcutaneously at Week 12|"sPGA 50 n(%) as Efficacy of Enbrel subcutaneously at Week 12, in terms of Proportion of patients who achieve a score of clear or minimal by the Static Physician Global Assessment (sPGA) and the proportion of patients with a reduction of PASI of at least 50% from baseline.
~The sPGA is a 6-category scale ranging from 5 = severe to 0 = none indicating the physician's overall assessment of the psoriasis severity focusing on indurations, erythema, and scaling. Treatment success of clear or minimal consists of none or minimal elevation in plaque, up to faint red coloration in erythema, and none or minimal fine scale over < 5% of the plaque."
16106893|NCT02112097|Drug|Efficacy of Enbrel subcutaneously at Week 24|"sPGA 50 n(%) as Efficacy of Enbrel subcutaneously at Week 24, in terms of Proportion of patients who achieve a score of clear or minimal by the Static Physician Global Assessment (sPGA) and the proportion of patients with a reduction of PASI of at least 50% from baseline.
~The sPGA is a 6-category scale ranging from 5 = severe to 0 = none indicating the physician's overall assessment of the psoriasis severity focusing on indurations, erythema, and scaling. Treatment success of clear or minimal consists of none or minimal elevation in plaque, up to faint red coloration in erythema, and none or minimal fine scale over < 5% of the plaque."
16106894|NCT02112097|Drug|Efficacy of Enbrel subcutaneously at Week 36|"sPGA 50 n(%) as Efficacy of Enbrel subcutaneously at Week 36, in terms of Proportion of patients who achieve a score of clear or minimal by the Static Physician Global Assessment (sPGA) and the proportion of patients with a reduction of PASI of at least 50% from baseline.
~The sPGA is a 6-category scale ranging from 5 = severe to 0 = none indicating the physician's overall assessment of the psoriasis severity focusing on indurations, erythema, and scaling. Treatment success of clear or minimal consists of none or minimal elevation in plaque, up to faint red coloration in erythema, and none or minimal fine scale over < 5% of the plaque."
16106895|NCT02112097|Drug|Efficacy of Enbrel subdermally at Week 12|"sPGA 50 n(%) as Efficacy of Enbrel subdermally at Week 12, in terms of Proportion of patients who achieve a score of clear or minimal by the Static Physician Global Assessment (sPGA) and the proportion of patients with a reduction of PASI of at least 50% from baseline.
~The sPGA is a 6-category scale ranging from 5 = severe to 0 = none indicating the physician's overall assessment of the psoriasis severity focusing on indurations, erythema, and scaling. Treatment success of clear or minimal consists of none or minimal elevation in plaque, up to faint red coloration in erythema, and none or minimal fine scale over < 5% of the plaque."
16106896|NCT02112097|Drug|Efficacy of Enbrel subdermally at Week 24|"sPGA 50 n(%) as Efficacy of Enbrel subdermally at Week 24, in terms of Proportion of patients who achieve a score of clear or minimal by the Static Physician Global Assessment (sPGA) and the proportion of patients with a reduction of PASI of at least 50% from baseline.
~The sPGA is a 6-category scale ranging from 5 = severe to 0 = none indicating the physician's overall assessment of the psoriasis severity focusing on indurations, erythema, and scaling. Treatment success of clear or minimal consists of none or minimal elevation in plaque, up to faint red coloration in erythema, and none or minimal fine scale over < 5% of the plaque."
16106897|NCT02112097|Drug|Efficacy of Enbrel subdermally at Week 36|"sPGA 50 n(%) as Efficacy of Enbrel subdermally at Week 36, in terms of Proportion of patients who achieve a score of clear or minimal by the Static Physician Global Assessment (sPGA) and the proportion of patients with a reduction of PASI of at least 50% from baseline.
~The sPGA is a 6-category scale ranging from 5 = severe to 0 = none indicating the physician's overall assessment of the psoriasis severity focusing on indurations, erythema, and scaling. Treatment success of clear or minimal consists of none or minimal elevation in plaque, up to faint red coloration in erythema, and none or minimal fine scale over < 5% of the plaque."
16106898|NCT02112097|Drug|PASI 75 n(%) subcutaneously at Week 12|PASI 75 n(%) as Efficacy of Enbrel subcutaneously at Week 12, in terms of the proportion of patients who achieved a reduction in score of at least 75% from baseline by the PASI.
16106899|NCT02112097|Drug|PASI 75 n(%) subcutaneously at Week 24|PASI 75 n(%) as Efficacy of Enbrel subcutaneously at Week 24, in terms of the proportion of patients who achieved a reduction in score of at least 75% from baseline by the PASI.
16106900|NCT02112097|Drug|PASI 75 n(%) subcutaneously at Week 36|PASI 75 n(%) as Efficacy of Enbrel subcutaneously at Week 36, in terms of the proportion of patients who achieved a reduction in score of at least 75% from baseline by the PASI.
16106901|NCT02112097|Drug|PASI 75 n(%) subdermally at Week 12|PASI 75 n(%) as Efficacy of Enbrel subdermally at Week 12, in terms of the proportion of patients who achieved a reduction in score of at least 75% from baseline by the PASI.
16106902|NCT02112097|Drug|PASI 75 n(%) subdermally at Week 24|PASI 75 n(%) as Efficacy of Enbrel subdermally at Week 24, in terms of the proportion of patients who achieved a reduction in score of at least 75% from baseline by the PASI.
16106936|NCT02111863|Drug|Cyclophosphamide|Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml 5% dextrose in water (D5W) over 1 hr.
16106905|NCT02112097|Drug|Adverse Reactions of Enbrel subdermally at Week 36|Adverse Reactions of Enbrel subdermally at Week 36, in number of Injection site reactions, Heart failure, Allergic Reactions, Blood problems/low blood counts, Nervous system, Infections, Malignancies, Immunogenicity, and Autoantibodies.
16106906|NCT02112097|Drug|Gadolinium|"For Right Upper Arm Total Persistent % subdermally, on MRI at 6 hrs, 12 hrs, and 24 hrs.
~Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9cc normal saline subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients."
16106907|NCT02112097|Drug|Gadolinium|"For Right Upper Arm Total Persistent % subcutaneously, on MRI at 6 hrs, 12 hrs, and 24 hrs.
~Gadolinium Magnevist® (gadopentetate dimeglumine) .1cc/ diluted with .9cc normal saline subcutaneously for 30 patients, and subdermally with ASIS Device for 30 patients."
16106908|NCT02112097|Drug|Gadolinium|For Right Upper Arm Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium subcutaneously on MRI.
16106909|NCT02112084|Behavioral|Individualized DPM|The intervention includes 7 LO phone sessions and 7 RO home visits provided by trained interventionists. The primary focus of the LO phone conversations will be on grief work issues, daily functioning, and emotional support. The calls will provide an opportunity to discuss how grief could be interfering with their daily functioning, dealing with grief-related feelings- emotions they are experiencing, the frustrations associated with taking on new responsibilities while still trying to meet their own needs, critical time periods like anniversaries and holidays, unfinished business, coping strategies, including using humor, and having realistic expectations about the bereavement process. The RO home visits will be based specifically on the bereaved partners' skill and knowledge needs.
16106910|NCT02112071|Behavioral|Exercise|Blended supervised-home based walking program 3-4 times per week for at least 30 minutes.
16106911|NCT02112058|Behavioral|A Family-Strengthening Program for Low-Income Families|"The program's central and most intensive component was a series of relationship and marriage education workshops for groups of couples that was offered in the first four to five months of enrollment in the program.
~Complementing the workshops was a second component, offered for the year after enrollment, that consisted of supplemental activities: educational and social events that were intended to build on and reinforce lessons from the curricula.
~The third component, family support services, paired couples with a specialized staff member who maintained contact with them and facilitated their participation in the other two components throughout the duration of the program."
16106912|NCT02112045|Drug|Granix|
16106913|NCT02112045|Drug|High dose melphalan (HDR)|
16106914|NCT02112045|Procedure|Autologous Stem Cell Transplant (ASCT)|
16106915|NCT02112032|Drug|MK-3475|This is a dose escalation study to determine the serious and non-serious adverse events that occur as the dose increases.
16106916|NCT02112032|Drug|Peginterferon alfa-2b|This is a dose escalation study to determine the serious and non-serious adverse events that occur from the combination of Peginterferon and MK-3475 as the doses increase.
16106917|NCT02112019|Procedure|Sialoendoscopy|
16106918|NCT02112019|Drug|saline|
16106919|NCT02112019|Drug|hydrocortisone|
16106920|NCT02112006|Procedure|0.5% bupivacaine injected in the forearm|Median, Ulnar, and Radial nerve blocks performed in the forearm
16106921|NCT02112006|Procedure|20-30ml of 0.5% bupivacaine.|supraclavicular, infraclavicular, or axillary nerve block using 20-30ml of 0.5% bupivacaine.
16106922|NCT02111993|Device|Standard Defibrillation Testing|Once the ICD is implanted, Standard Defibrillation Threshold (DFT) testing will begin. A low energy shock will be delivered to the heart at the peak of the T wave to induce ventricular fibrillation (VF). Once VF is induced, a rescue shock of 25J will be delivered to restore sinus rhythm. This process will be repeated once more after 5 minutes.
16106923|NCT02111993|Device|Upper Limit of Vulnerability Testing|Once the ICD is implanted, Upper Limit of Vulnerability (ULV) testing will commence. An 18 J shock will be delivered will at different points from the t-wave. If VF is not induced with any of these shocks, then the ULV will be considered to be 18J. If VF is induced, then a 25 J rescue shock will be delivered.
16106924|NCT02111980|Device|RF Assure Scanning|CIED and temporary pacemaker patients will be scanned with RF surgical sponge detection wand and mat as well as with and without the RF sponge. The scanning will only be conducted on the device scheduled for removal. Patients will have device interrogated before and after scanning (for CIEDs) to determine if there have been any clinically significant changes in programming or settings due to scanning with RF technology. Vitals will be monitored and recorded before, during, and after scanning.
16106925|NCT02111967|Other|Questionnaire administration|
16106926|NCT02111967|Other|Laboratory biomarker analysis|
16106927|NCT02111954|Diagnostic Test|1 PET/CT with F-18-FCH + 1 PET/CT with Ga-68-NODAGA-MJ9|Each patient will have two PET/CT
16106928|NCT02111941|Other|Laboratory Biomarker Analysis|Correlative studies
16106929|NCT02111941|Biological|Multi-epitope Folate Receptor Alpha-loaded Dendritic Cell Vaccine|Given ID
16106930|NCT02111928|Device|NovaTears® Eye Drops|Topical eye drops for lubrication of the ocular surface
16106931|NCT02111915|Behavioral|THPP-P|Trial participant s who are in the THPP group will receive, in addition to Enhanced Usual Care (EUC), 14 sessions of THPP (simplified cognitive behaviour therapy) starting from their recruitment in the third trimester until up to 5 months after child birth.
16106932|NCT02111915|Other|EUC|EUC will comprise communicating the results to the mother's Lady Health Worker and medical officer (MO) at the Basic Health Unit (BHU) of her area, providing the MO with the WHO mental health gap (mhGAP) guidelines for the treatment of depression, and providing guidance on referral of depressed mothers to mental health services.
16106933|NCT02111889|Other|[11C] kinase inhibitor PET [15O]water PET and tumor biopsies.|[11C] kinase inhibitor PET (i.e. sorafenib and erlotinib in this study, with the aim to investigate others in future studies) and [15O]water PET will be performed before and after 2 weeks of treatment. Tumor biopsies will be performed before and after 2 weeks of therapy.
16106934|NCT02111863|Drug|Aldesleukin|Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
16106935|NCT02111863|Drug|Fludarabine|Fludarabine 25 mg/m^2/day (intravenous piggyback) IVPB daily X 5 days.(The fludarabine will be started approximately 1-2 hours after the cyclophosphamide on Days -5 and -4)
16106937|NCT02111863|Biological|4-1BB Selected Tumor Infiltrating Lymphocytes (TIL)|On day 0, cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (one to four days after the last dose of fludarabine).
16106938|NCT02111850|Biological|Anti-MAGE-A3-DP4 TCR PBL|Day 0: cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes
16106939|NCT02111850|Drug|Cyclophosphamide|Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg /day X 2 days over 1 hr.
16106940|NCT02111850|Drug|Fludarabine|Days -7 to -3: Fludarabine 25 mg/m2 /day IVPB daily over 30 minutes for 5 days.
16106941|NCT02111850|Drug|Aldesleukin|Aldeskeukin 720,000 IU/kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).
16106942|NCT02111837|Other|Standard infant formula|
16106943|NCT02111837|Other|Standard infant formula with PL1|
16106944|NCT02111837|Other|Standard infant formula with PL2|
16106945|NCT02111824|Device|MIMIG System|Minimally Invasive MultiModality Imaging Guidance System (MIMIG)
16106946|NCT02111824|Drug|Indocyanine Green (ICG)|Use of ICG as staining for fiberoptic visualization of lung tissue via introducer needle prior to obtaining tissue samples.
16106947|NCT02111811|Other|Veterans Work and Health Initiative|CBT based intervention focused on work productivity
16106948|NCT02111798|Drug|Placebo|Participants will be randomly assigned to receive placebo powder in twice-daily capsules at the end of week 2.
16106949|NCT02111798|Drug|Bupropion XL|Participants will be randomly assigned to receive bupropion XL 150mg/day in twice-daily capsules at the end of week 2.
16106950|NCT02111798|Behavioral|Abstinence Initiation|Participants will provide urine samples thrice weekly during weeks 1-6 of the study. Urine samples will be tested immediately onsite for evidence of recent cocaine exposure. Participants who do not provide 3 urine samples that test negative for cocaine by the end of week 6 will be assigned to an Abstinence Incentive condition.
16106951|NCT02111798|Behavioral|Relapse Prevention|Participants will provide urine samples thrice weekly during weeks 1-6 of the study. Urine samples will be tested immediately onsite for evidence of recent cocaine exposure. Participants who provide 3 urine samples that test negative for cocaine will be promptly assigned to a Relapse Prevention incentive condition.
16106952|NCT02111785|Drug|Dexamethasone|Treatment with a short course of oral dexamethasone
16106953|NCT02111785|Procedure|Burr Hole Craniostomy|Treatment with surgical burr hole craniostomy and evacuation of SDH
16106954|NCT02111772|Biological|Rhinovirus|
16106955|NCT02111759|Procedure|knee flexion angle 1|0 degrees of knee flexion during ACL graft fixation
16106956|NCT02111759|Procedure|knee flexion angle 2|30 degrees of knee flexion during ACL graft fixation
16106957|NCT02111746|Drug|Exparel|Participants will receive 266mg of liposomal bupivicaine (equivalent of one 1.3% 20ml vial of EXPAREL®) diluted in 60ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.
16106958|NCT02111746|Drug|Bupivacaine hydrochloride|Participants will receive 125mg of bupivacaine hydrochloride (equivalent of one 0.25% 50ml or five 0.25% 10ml vials ) diluted in 30ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.
16106959|NCT02111746|Drug|Patient Controlled Analgesia (PCA)|Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day
16106960|NCT02111733|Other|Hs-TNT dosage|Bloodwork before and after hemodialysis for high sensibility troponins T blood level
16106961|NCT02111720|Behavioral|Maybe, Maybe Not|The goals of session one are to introduce participants to the intervention, to assess current decision context, to assist in the clarification of participant values, and to encourage the participant to set specific goals for disclosure decision-making. The goals for session two are to explore the participants' motivations to disclose or not to disclose and the potential costs and rewards of both disclosing and not disclosing. The goals for session three are to guide participants through disclosure decision making, and to support comfort/acceptance with decisions made. The goal of session four is to support the decision-making process. The booster session is used to reinforce the effects of the intervention through continued discussion of disclosure decisions in the preceding months, strategies used in disclosing, and rewards and costs of decision-making.
16106962|NCT02111720|Behavioral|Comprehensive Risk Counseling and Services|CRCS combines traditional case management and HIV risk-reduction in an individualized, client-centered program which focuses on the reduction of risk behavior and addresses a client's psychosocial and medical needs.CRCS focuses on seven core elements: recruitment and engagement; screening, enrolling, and assessing; prevention planning; risk reduction counseling; referrals and service coordination; monitoring; and discharge and maintenance. These core elements represent the framework of the intervention, and provide enough flexibility to allow implementation that most appropriately serves the needs of clients.
16106963|NCT02111707|Drug|Rectal indomethacin 100mg one time before or after ERCP|Patients will receive rectal indomethacin suppository 30 minutes before or immediately after ERCP for prevention of post-procedure pancreatitis. Patients will be randomized to the timing of administration.
16106964|NCT02111694|Behavioral|Bottle Type|Infants will be fed from a conventional, clear bottle during one feeding and from an opaque, weighted bottle from another feeding
16106965|NCT02111681|Device|Calypso Beacon Implantation|Bronchoscopic Calypso Beacon Implantation
16106966|NCT02111655|Device|Second generation surveillance of AVF|"Doppler ultrasound and transonic dilution method technique will be performed in the experimental group quarterly.
~QA will be measured by both techniques and haemodynamic repercussion stenosis will be evaluated by doppler ultrasound."
16106967|NCT02111655|Procedure|vital signs|Effective blood flow, venous pressure, arterial pressure, at the beginning and at the end of the dialysis session
16106968|NCT02111655|Procedure|physical examination of AVF|Predialysis physical examination of AVF every dialysis session.
16106970|NCT02111655|Procedure|urea method|Quarterly recirculation with urea method.
16108269|NCT02101853|Biological|Blinatumomab|Given IV
16106971|NCT02111642|Other|Online risk calculator|A new online risk calculator tool has been developed to predict a woman's individual risk of developing de novo stress urinary incontinence after prolapse surgery. This validated tool has been shown to outperform preoperative prolapse reduction stress testing results and expert predictions when providing risk assessment of de novo stress urinary incontinence after vaginal prolapse surgery. After inputting individual patient characteristics, including patient age, body mass index, number of vaginal deliveries, presence or absence of urgency urinary incontinence and diabetes, and prolapse reduction stress testing results if available, this tool calculates the theoretical risk of postoperative de novo stress urinary incontinence both with and without an anti-incontinence procedure.
16106972|NCT02111629|Drug|Fluconazole and Secnidazole|
16106973|NCT02111616|Behavioral|Survivorship Care Plan (SCP)|Cancer Survivorship Care Plan (SCP) adapted from JourneyForward template. Each SCP is individualized to patient's care regimen. SCP is delivered at the conclusion of cancer treatment and during the patient's transition visit with nurse practitioner or physician assistant.
16106974|NCT02111616|Behavioral|Coordinated PCP visit|Visit with PCP scheduled on behalf of patient at the conclusion of cancer treatment and patient's transition visit.
16106975|NCT02111603|Drug|Colesevelam|Subjects will receive 1875 mg of Colesevelam orally twice daily for 10 days
16106976|NCT02111590|Drug|Immunoglobulins|SCIG dosage is individualized for each patient according to previous IVIG dosage
16106977|NCT02111577|Biological|DCVAC/PCa|DCVAC/PCa concurrently with docetaxel plus prednisone every 3 weeks (± 7 days). DCVAC/PCa was administered at least 7 days before or and at least 7 days after the nearest chemotherapy (days 8-15 of chemotherapy cycles). After discontinuation of chemotherapy for any reason, each following dose of DCVAC/PCa was given every 4 weeks (-7/+14 days) for up to a total of 15 doses.
16106978|NCT02111577|Biological|Placebo|Placebo concurrently with docetaxel plus prednisone every 3 weeks (± 7 days). Placebo was administered at least 7 days before or and at least 7 days after the nearest chemotherapy (days 8-15 of chemotherapy cycles). After discontinuation of chemotherapy for any reason, each following dose of placebo was given every 4 weeks (-7/+14 days) for up to a total of 15 doses.
16106979|NCT02111564|Drug|Rivaroxaban, 10 mg|Patients, randomly allocated to the rivaroxaban arm, with a creatinine clearance at screening greater than or equal to (>=)50 mL/min will receive 10 mg rivaroxaban tablet with or without food.
16106980|NCT02111564|Drug|Rivaroxaban, 7.5 mg|Patients, randomly allocated to the rivaroxaban arm, with a creatinine clearance at screening from >=30 to less than (<)50 mL/min will receive 7.5 mg rivaroxaban tablet with or without food.
16106981|NCT02111564|Drug|Placebo|All patients, randomly allocated to the placebo arm, will receive one placebo tablet with or without food.
16106982|NCT02111551|Drug|DMXB-A 150 mg|
16106983|NCT02111551|Other|placebo|
16106984|NCT02111551|Drug|DMXB-A 75 mg|
16106985|NCT02111538|Other|Dietary advice|Standard dietary advice are provided to all patients at baseline and during the follow-up to all requiring or asking for
16106986|NCT02111512|Drug|Administration of Live attenuated influenza vaccine (LAIV)|
16106987|NCT02111499|Drug|LAS41004-IMP1|daily topical application
16106988|NCT02111499|Drug|LAS41004 IMP2|daily topical application
16106989|NCT02111499|Drug|LAS41004 IMP3|daily topical application
16106990|NCT02111499|Drug|LAS41004 IMP4|daily topical application
16106991|NCT02111499|Drug|LAS41004 IMP6|daily topical application
16106992|NCT02111499|Drug|LAS41004 IMP5|once daily, topical
16106993|NCT02111486|Other|breakfast|
16106994|NCT02111473|Drug|Testosterone|Testosterone 250 mg injection per 3-4 weeks for 6 months
16106995|NCT02111460|Radiation|Loco-regional Radiotherapy|with or without Loco-regional Radiotherapy
16106996|NCT02111447|Drug|Propofol|Propofol infusion with nasal oxygen
16106997|NCT02111447|Drug|Propofol|Propofol infusion with an LMA
16106998|NCT02111447|Drug|Sevoflurane|Sevoflurane with an LMA
16106999|NCT02111447|Drug|Isoflurane|Isoflurane with an LMA
16107000|NCT02111434|Drug|Testosterone|Testosterone 250 mg injection per 3-4 weeks for 6 months
16107001|NCT02111421|Drug|Dexmedetomidine 01|Initial dose of dexmedetomidine was 1.0 μg/kg, with dose adjustment intervals of 0.1μg/kg in first three turning points and 0.05μg/kg in the last four turning points,after the umbilical cord was clapped.The wight used to calculate the dose of dexmedetomidine would be that the total weight of the mother minus the weight of the placenta, amniotic fluid and fetal.
16107002|NCT02111421|Drug|Dexmetomidine 02|Initial dose of dexmedetomidine was 1.0 μg/kg, with dose adjustment intervals of 0.1μg/kg in first three turning points and 0.05μg/kg in the last four turning points,as soon as the spinal anesthesia
16107003|NCT02111382|Other|CV4 Cranial (4th ventricle technique) Osteopathic Manipulative|"The participant will be in supine position during the whole procedure. The practitioner sits behind the participant's head, contacts participant's lateral protuberances of the squama occipitalis (medially to the occipitomastoid suture) with the thenar eminence of both hands.
~When the practitioner feels the PRM (a pulsating rhythm caused by liquor production and reabsorption), the flexion phase will be resisted and the extension phase exaggerated. The compressive force is held until the PRM stops (event known as 'Still point'). The compression will be held until the practitioner feels PRM gradual return; the compression will be slowly diminished, and then, the practitioner remove the hands from the occipital bone, laying the participant's head on the table.
~The CV4 technique will be performed by an osteopath D.O. - member of the Brazilian Register of Osteopaths."
16107004|NCT02111382|Other|CV4 (4th ventricle technique) manual therapy sham technique|"The participant will be in supine position and the practitioner will be seated behind the participant's head. The practitioner places the fingers (2nd to 5th) under the occipital bone, touching only the squama occipitalis. The practitioner will hold this position for 5 minutes, and after this period the participant's head will be placed on the table.
~The CV4 sham will be performed by a registered physiotherapist."
16107005|NCT02111369|Drug|Propranolol|After a discussion of the risks and benefits of propranolol therapy, the patient will then be given a prescription by the principal investigator for propranolol. This prescription will consist of a starting dose of generic immediate-release at 10 mg three times daily (30 mg each day) with an increase in dose in 5-7 days if there is no effect (60 mg each day) and if the patient had demonstrated no side effects. Dose may be increased to 240 mg each day depending on patient improvement and side effect profile.
16107006|NCT02111369|Procedure|Botulinum Toxin|At the second evaluation, patient will receive botulinum toxin injections. The risks and benefits of botulinum toxin therapy will be explained to the patient, and bilateral injections will take place.
16107007|NCT02111356|Device|Phinhole glasses|Wearing the pinhole glasses (Trayner Pinhole Glasses, Trayner Glasses, U.K.)
16107008|NCT02111343|Other|Computer-based auditory training (CBAT)|"There are 3 listening games (i.e. Doggy, Who-Is-Right, Story-in-noise) that target on speech-in-noise training and 1 listening game (i.e. TATP) that aims to train dichotic listening.
~Patient was required to undergo the training for 30 minutes per day, 5 sessions per week, for a duration of 12 weeks. Parents were advised to keep a journal to record child's training hour of the day."
16107009|NCT02111330|Drug|PBF-509|
16107010|NCT02111330|Drug|Placebo|
16107011|NCT02111317|Drug|ASP015K|oral
16107012|NCT02111317|Drug|verapamil|oral
16107013|NCT02111304|Drug|iOWH032|
16107014|NCT02111291|Biological|Collagenase SANTYL® Ointment|Daily application directly to the ulcer bed, approximately 2 mm thick.
16107015|NCT02111291|Biological|Hydrogel (if needed) and foam dressing|Daily application of hydrogel directly to the ulcer bed (if necessary), covered with foam dressing
16107016|NCT02111278|Other|Lumbar Manipulation|The manipulating therapist performs the lumbar manipulation technique. With the patient supine, the therapist stands opposite the side to be manipulated. The patient is passively side-bent away from the therapist. The therapist rotates the thoracic spine and then delivers a quick posterior and inferior thrust through the anterior superior iliac spine. The manipulation is performed on the side the patient reported to be more symptomatic. If the patient is unable to identify a more painful side, the side to be manipulated is left to the manipulating therapist discretion. If a cavitation is experienced, no more manipulations are performed that session. If no cavitation is produced, the patient is repositioned, and the manipulation is attempted again. If no cavitation is experienced again, the therapist attempts to manipulate the opposite side. A maximum of two attempts per side will be attempted.
16107017|NCT02111278|Other|Sham Manipulation|The manipulating therapist will perform the sham lumbar manipulation technique with the patient side-lying. The therapist passively flexes both hips until slight lumbar flexion is noted at the patient's most painful vertebral level. The therapist will take time palpating patient's spine taking care to avoid rotating the spine. The therapist will then place both hands on the same lumbar spinous process. An equal and opposite force is then applied to the spinous process with both hands. No physiologic motion is expected with this technique. The patient will then be setup for the same sham technique on the opposite side. The sham manipulation technique will be performed in an attempt to blind the patient to group allocation. This technique is designed to provide similar hands on treatment time as the manipulation intervention.
16107018|NCT02111278|Other|Physical Therapy|Patients will receive 4 weeks of physical therapy with 2 visits per week. The treating physical therapist is blinded to group allocation. The treating physical therapist will prescribe exercises based on patient presentation. Therapy visits last approximately 45-60 minutes depending of patient ability to perform exercises. The treating physical therapist will perform no mobilizations or manipulations on the patient.
16107019|NCT02111265|Drug|Remifentanil|"Remifentanil 0.1-0.2μg/ ( kg•min) is continuously pumped at steady speed for analgesia for induction and maintenance of anesthesia.
~Remifentanil is stopped before skin closure"
16107020|NCT02111265|Drug|Cisatracurium|"Cisatracurium 0.15 mg/kg for induction and 0.12 mg/kg/h continuous infusion for maintenance of anesthesia.
~Cisatracurium is stopped before skin closure."
16107021|NCT02111265|Drug|Sufentanil|Before skin closure, remifentanil is stopped and sufentanyl 0.1μg/kg is given by intravenous injection.
16107022|NCT02111265|Device|Bispectral index(BIS) monitor|BiS is maintained at 40-60 during anesthesia.
16107023|NCT02111252|Drug|TAK-850|TAK-850 injection
16107024|NCT02111239|Device|CTA|pelvic/abdominal CTA scan
16107025|NCT02111239|Device|MRA|pelvic/abdominal MRA scan
16107026|NCT02111226|Other|SMS text messaging|short message service
16107027|NCT02111213|Behavioral|Virtual Advisor|The virtual advisor is named Carmen. She is an animated, computer-generated figure that speaks to participants and gives advice and support for physical activity.
16107028|NCT02111213|Behavioral|Promotora for physical activity|A promotora is a trained, lay health worker. Promotoras will be trained and supervised to provide advice, support and guidance to people to encourage them to be more physically active. They work with people face to face and by telephone to offer support and advice.
16107029|NCT02111200|Drug|Sodium Benzoate|Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.
16107030|NCT02111200|Drug|Sodium Phenylbutyrate|Subjects will be instructed to take the study medication with meals (08:00 breakfast; 13:00 lunch; 19:00 dinner) for 3 days.
16107031|NCT02111187|Drug|LDE225|Sonidegib was given as an oral drug at 800mg daily for 28 days prior to prostetoctomy
16107032|NCT02111174|Device|Scrambler Therapy|
16107033|NCT02111174|Device|Sham Therapy|
16107034|NCT02111161|Drug|IVIG (Privigen)|Three doses of 25 g IVIG (250 ml)
16107035|NCT02111161|Drug|Saline 0.9%|Three doses of Saline 0.9% (250 ml)
16107036|NCT02111148|Procedure|Urea and creatinine|the vagina will be washed with 5ml saline, urea and creatinine will be detected biochemically in the vaginal wash.
16107037|NCT02111148|Procedure|Nitrazine|Nitrazine detection in vaginal wash
16107038|NCT02111148|Drug|5ml saline|the vagina will be washed with 5ml saline and vaginal wash will be collected.
16107039|NCT02111135|Biological|b-OPV|
16107040|NCT02111135|Biological|m-OPV2|
16107041|NCT02111135|Biological|m-IPV HD|
16107042|NCT02111135|Biological|t-IPV|
16107043|NCT02111122|Drug|Sodium Oxybate|
16107044|NCT02111122|Drug|Placebo|
16107045|NCT02111109|Device|Side Stream Dark Field Microscopy|
16107046|NCT02111096|Drug|LY2409021|Administered orally
16107047|NCT02111096|Drug|Sitagliptin|Administered orally
16107048|NCT02111096|Drug|Placebo|Administered orally
16107049|NCT02111096|Drug|Metformin|Administered orally
16107050|NCT02111096|Drug|Sulfonylurea|Administered orally
16107051|NCT02111083|Biological|Insulin Lispro|LY275585 administered SC.
16107052|NCT02111070|Biological|IL-YANG FLU Vaccine|0.5mL
16107054|NCT02111044|Drug|ITF2984 500 mcg|ITF2984 500 mcg sc b.i.d for 4 weeks
16107055|NCT02111044|Drug|ITF2984 1000 mcg|ITF2984 1000 mcg sc b.i.d for 4 weeks
16107056|NCT02111044|Drug|ITF2984 2000 mcg|ITF2984 2000 mcg sc b.i.d for 4 weeks
16107057|NCT02111018|Device|CytoSorb Device|
16107058|NCT02111018|Procedure|CVVH|
16107059|NCT02110992|Drug|Docetaxel|Docetaxel 15mg/m2 IV, given days 1, 8, and 15 during SBRT
16107060|NCT02110992|Radiation|Stereotactic Radiation|SBRT will be given over 5 fractions separated by > 48 hours. Dose will be determined based upon dose escalation schedule and will range from 25-40 Gy.
16107061|NCT02110979|Behavioral|Use of a PDA to assist shared decision making|
16107062|NCT02110966|Drug|Mepivacaine|Drug: Tramadol 1.8 ml of Mepivacaine 2% epinephrine 1:100000.
16107063|NCT02110966|Drug|Mepivacaine plus Tramadol|0.5 ml of Tramadol mixed with 1.3 ml of Mepivacaine.
16107064|NCT02110953|Combination Product|irinotecan-eluting beads|Receive irinotecan hydrochloride-eluting beads via hepatic artery embolization
16107065|NCT02110953|Procedure|hepatic artery embolization|Receive irinotecan hydrochloride-eluting beads via hepatic artery embolization
16107066|NCT02110940|Other|Neurodynamic mobilization exercise|"The mobilization exercise is conducted with 10 repetitions for each action, the action is hold for 5 seconds when subjects had the stretch feeling. The series of exercise is told to perform 2 sets a day, daily practice.
~Subjects' conditions will be reviewed at the end of 4th and 8th week. An exercise log book will be provided for each subject to record down the compliance of the exercise."
16107067|NCT02110940|Other|Conservative Physiotherapy|The control group is assigned to received conventional treatment in the physiotherapy department with the standard rehabilitation protocol consisted of electrotherapy for pain relief, strengthening exercise to increase the strength of the thigh
16107068|NCT02110927|Device|Transcutaneous microcurrent|Microcurrent in the abdominal region with four transcutaneous electrodes in a parallel position, intensity below the sensitivity threshold and a maximum of 1 mA. Every 15 minutes changed from 25 Hz to 10 Hz.
16107069|NCT02110927|Device|Aerobic exercise|50 minutes of aerobic moderate-intensity exercise (45-55% of maximal oxygen consumption (VO2 max)) using Karvonen´s formula, performed on a cycloergometer. Were used Borg scale (12-13), Polar® heart monitors to control heart rate and K4b2 to analyze the quantity of oxygen (O2) consumption and carbon dioxide (CO2) produced during exercise.
16107070|NCT02110914|Behavioral|Coaching|"Coaching is based on the principles of the Co-active coaching model and performed by a certified coach. At the first coaching session the coach and client will make an agreement about the format for subsequent coaching sessions. The first and the last coaching session will always be face to face at the hospital and last 1- 1½ hours. Intervening coaching sessions will be approximately 60 minutes by phone or face to face. In total, ten coaching sessions will be offered, one every 1-2 weeks early in the program and one every 2-4 weeks later in the process. The duration of the coaching intervention will be between 6 and 9 months."
16107071|NCT02110901|Drug|PRT-201|
16107072|NCT02110901|Drug|Placebo|
16107075|NCT02110862|Other|Transittime. Defecography|
16107076|NCT02110849|Radiation|Proton|Proton Therapy for Prostate Cancer
16107077|NCT02110836|Dietary Supplement|Glucose ingestion|Glucose ingestion during exercise at 1.8 g/min
16107078|NCT02110836|Dietary Supplement|Sucrose ingestion|Sucrose ingestion during exercise at 1.8 g/min
16107079|NCT02110810|Drug|Indomethacin|Indomethacin suppository of 100 mg immediately afterwards while still under sedation
16107080|NCT02110810|Drug|2.6-g suppository of glycerin|to receive a 2.4 g of glycerin suppository immediately afterwards while still under sedation
16107081|NCT02110797|Other|biological markers and evaluation of the mineral density at the lumber spine using DEXA|
16107082|NCT02110784|Drug|Eurartesim tablets|dosage bands: 24 to <36 kg body weight: 2 tablets a day for three consecutive days 36 to <75 kg body weight: 3 tablets a day for three consecutive days 75 to 100 kg body weight: 4 tablets a day for three consecutive days
16107083|NCT02110771|Behavioral|GAÏA - facial affect recognition targeted|"2 sessions of one hour per week with therapist. Intervention proposes 3 stages : 1)discovering and learning facial affects recognition and discrimination criterions for joy, sadness and anger (photos exercises); 2) facial affect recognition training (computer based and role game exercises); 3) generalization to other emotions (photos, role games and computer based exercises).
~The therapist chooses the change of stages; 5 sessions or more are proposed for the generalization stage."
16107084|NCT02110771|Behavioral|RECOS - attentional process targeted|2 sessions of one hour per week with therapist the first of those two session is allocated to paper and pen exercises (search and validation of strategies to resolve cognitive training exercises or functional problems). the second session is allocated to computer based exercises.
16107085|NCT02110758|Other|Pilot of Patient-Centered Oncology Care|Patient-Centered Oncology Care addresses six domains: track & coordinate referrals, provide access and communication, identify and coordinate patient populations, plan and manage care, track & coordinate care, and measure and improve performance.
16107086|NCT02110745|Drug|Sevofluorane|Comparison of different induction drugs and techniques
16107087|NCT02110745|Drug|Propofol|Comparison of different induction drugs and techniques
16107088|NCT02110732|Dietary Supplement|Lactobacillus rhamnosus GG|
16107089|NCT02110719|Drug|Celebrex|
16107090|NCT02110719|Drug|Gabapentin|
16107091|NCT02110719|Drug|IV acetaminophen|
16107092|NCT02110719|Drug|oral acetaminophen|
16107093|NCT02110719|Drug|oral ibuprofen|
16107094|NCT02110719|Drug|percocet|
16107095|NCT02110719|Drug|vicodin|
16107096|NCT02110719|Drug|Oxycodone|
16107097|NCT02110719|Drug|dilaudid|
16107098|NCT02110719|Drug|Dexamethasone|
16107099|NCT02110719|Drug|zofran|
16107100|NCT02110706|Drug|Rituximab|Intervention (rituximab): The treatment group will receive a total of two cycles of rituximab separated by 6 months. Each cycle is defined as one infusion (375mg/m2 IV) per week for four consecutive weeks
16107101|NCT02110706|Drug|Placebo|The placebo group will receive a vehicle control infusion
16107181|NCT02110108|Device|Revlite Laser System|Revlite Laser System for the Treatment of Facial Solar Lentigines
16107102|NCT02110693|Other|Interviewer and tablet administration of the TAPS Tool|All participant will self-administer substance use screening instrument (TAPS Tool) on a tablet computer and will be administered the TAPS Tool by an interviewer.
16107103|NCT02110680|Device|Sports TENS 2|transcutaneous electric stimulation
16107104|NCT02110667|Device|Transperineal Ultrasound|
16107105|NCT02110654|Drug|Montelukast|
16107106|NCT02110654|Drug|mometasone furoate nasal spray|
16107107|NCT02110641|Behavioral|Weight Loss Counseling|The intervention will be based on the Diabetes Prevention Program weight loss program, which uses a combination of reduced caloric intake, increased physical activity, and behavior therapy. The content of the weight loss program will be similar for the in-person and telephone interventions, but the approach will vary (i.e., in-person vs. telephone counseling). The weight loss intervention will be conducted by a Registered Dietitian, who has training in exercise physiology and behavior modification.
16107108|NCT02110628|Procedure|Roux-en-Y anastomosis|Roux-en-Y anastomosis
16107109|NCT02110628|Procedure|Roux-en-Y+Pouch anastomosis|Roux-en-Y+Pouch anastomosis
16107110|NCT02110615|Other|Primary Care Practice Changes|The clinical intervention components included (1) advanced training on clinical quality improvement and obesity prevention, assessment, management; (2) computerized, point-of-care decision support tools for clinicians; (3) implementation of multi-disciplinary weight management programs within the community health centers, e.g. Healthy Weight Clinics (HWC); (4) integrating community health workers into the primary care and HWC teams; and (5) health center environmental changes to support behavior change modification.
16107111|NCT02110602|Other|Diet high in amino acid levels|Meals will be prepared in the Clinical Research Center Metabolism & Nutrition Metabolic Kitchen, and participants will eat only this food during the controlled-diet periods of the study. The diets will contain equivalent calories (matched to the requirements of each participant) and either a low or high percentage of all BCAAs relative to protein content.
16107112|NCT02110602|Other|Diet low in amino acid levels|Meals will be prepared in the Clinical Research Center Metabolism & Nutrition Metabolic Kitchen, and participants will eat only this food during the controlled-diet periods of the study. The diets will contain equivalent calories (matched to the requirements of each participant) and either a low or high percentage of all BCAAs relative to protein content.
16107113|NCT02110589|Device|Epidetect|Topically aplied muscle tonicity monitor (EMG recording)
16107114|NCT02110563|Drug|DCR-MYC|"Dosing: 2 hour IV infusion on Day 1 and 8 of each 21 day cycle.
~Starting dose: 0.1mg/kg/dose
~Dose escalation: 100%, 50%, or 25% increase in subsequent cohorts depending upon toxicity.
~Number of cycles: until progression or unacceptable toxicity develops."
16107115|NCT02110550|Other|IPS.emmax endocrown|
16107116|NCT02110537|Procedure|Active Acupuncture|Active acupuncture treatment group consists of electroacupuncture (EA) and intradermal acupuncture (IDA). For EA treatment, unilateral PC5, PC6, ST36, and ST37 are chosen. Disposable, sterile needles and low frequency electrical stimulator (ES-160, ITO, Japan) are used. Each needle is inserted to the depth of 2 ± 0.5 cm with a 90 degree angle. Thereafter, needles are connected with the pole and electrical stimulation is applied with 2Hz, continuous wave current for 20 minutes. For IDA treatment, bilateral HT7 and TF4 are selected. Disposable, sterile, sticker-type needles (0.18 mm x 1.3 mm x 1.5mm) are used. Attached needles are maintained as long as possible.
16107117|NCT02110537|Procedure|Sham acupuncture|For sham intervention, nonacupuncture points are used. As with active treatment group, two types of acupuncture, sham EA and sham IDA, compose the sham intervention. Electrical acupuncture is connected but electrical stimulation is not given to sham acupuncture group.
16107118|NCT02110537|Drug|flecainide|Both groups commonly take antiarrhythmic medication (flecainide 75 mg twice daily) during study period. Flecainide administration is initiated 2 weeks before electrical cardioversion and maintain during follow up period.
16107119|NCT02110524|Device|Percutaneous Transluminal Angioplasty|
16107120|NCT02110511|Other|blended lentils|blended lentils burritto breakfast
16107121|NCT02110511|Other|whole lentils|whole lentils breakfast burritto
16107122|NCT02110511|Other|no lentils|No lentils control breakfast burritto
16107123|NCT02110485|Other|Patient Activation Tool|An interactive tablet based tool designed to (1) teach patient activation strategies; (2) provide evidence-based information about a health condition, (3) help patient/caregiver dyads recognize and clarify their own values, and (4) provide guidance in decision making and communication among those involved with the decision.
16107124|NCT02110472|Device|Corneal inlay|Presbia Flexivue Microlens implantation in corneal pocket created in nondominant eyes of emmetropic presbyopes.
16107125|NCT02110459|Drug|POL7080|Intravenous infusion
16107126|NCT02110446|Drug|SS-1|"The patients will be divided into two groups (A and B) at random and all of them keep the routine treatment in the rheumatology OPD. Group A patients will receive 12 weeks SS-1 treatment first, and then stop the SS-1 for 4 weeks for wash-out phase, and then receive 12weeks placebo treatment. Group B patients receive 12 weeks placebo first, and then stop the placebo treatment for 4 weeks for wash-out phase, and then receive 12weeks SS-1 treatment.
~SS-1 is composed of 3 traditional Chinese herbal formula: Gan-Lu-Yin, Sang-Ju-Yin and Xuefu-Zhuyu-Decoction with the ratio of 2:1:1. The placebo is composed with corn starch, pigment and minimal dose of 1% SS-1. Patients in both groups take 6 gram of SS-1/Placebo three times per day."
16107127|NCT02110446|Drug|Placebo|The placebo is composed of corn starch, pigment and minimal dose of 1% SS-1. Patients take 6 gram of experiment medicine three times per day.
16107128|NCT02110433|Device|Placebo group|patient will be managed as recommended by ESC guidelines and follow up will be in accordance to ESC recommendations
16107129|NCT02110433|Device|Cordiva System (R)|Patients have to answer to 8 specific binary questions based on the main precipitating factors for decompensation and measure their body weight every day. If not they will be contact after two missing measures. Patient will be contact by phone call every month in order to reinforce the initial patient therapeutic education and patient-'s compliance. Patient have access to specific printed documents and to a specific web based platform where he can find some PowerPoint presentation on CHF aetiology, signs and therapy and where he can try to answer to monthly quiz in whom questions are based on key messages about CHF according to guidelines and consensus paper on patient therapeutic education.
16107182|NCT02110095|Device|Picosure Laser System|Picosure Laser System for the Treatment of Unwanted Tattoos
16107183|NCT02110082|Biological|Urelumab|
16107184|NCT02110082|Biological|Cetuximab|
16107130|NCT02110433|Device|BNP heartcheck|Patients had to measure the BNP plasma level using Alere home based BNP device heartcheck in a weekly basis in order to follow this parameter up. In case of clinical signs of CHF or a significant weight increase identified by the tele monitoring or the patient, the nurse will ask to the patient to do an extra measurement of home BNP testing in order to exclude a CHF decompensation (BNP < 100 pg/ml or remaining stable (< 30% increase).
16107131|NCT02110420|Drug|CC-90001|CC-90001 10mg will be administered as a single dose
16107132|NCT02110420|Drug|CC-90001|CC-90001 30mg will be administered as a single dose
16107133|NCT02110420|Drug|CC-90001|CC-90001 60mg will be administered as a single dose
16107134|NCT02110420|Drug|CC-90001|CC-90001 120mg will be administered as a single dose
16107135|NCT02110420|Drug|CC-90001|CC-90001 240mg will be administered as a single dose
16107136|NCT02110420|Drug|CC-90001|CC-90001 10mg will be administered daily for 14 days
16107137|NCT02110420|Drug|CC-90001|CC-90001 30mg will be administered daily for 14 days
16107138|NCT02110420|Drug|CC-90001|CC-90001 60mg will be administered daily for 14 days
16107139|NCT02110420|Drug|CC-90001|CC-90001 120mg will be administered daily for 14 days
16107140|NCT02110420|Drug|CC-90001|CC-90001 240mg will be administered daily for 14 days
16107141|NCT02110420|Drug|Placebo|Placebo will be administered once daily for up to 14 days depending on the Part of the study
16107142|NCT02110420|Drug|CC-90001|CC-90001 480mg will be administered as a single oral dose
16107143|NCT02110420|Drug|CC-90001|CC-90001 720mg will be administered as a single oral dose
16107144|NCT02110420|Drug|CC-90001|CC-90001 480mg will be administered daily for 14 days
16107145|NCT02110407|Device|tDCS|transcranial direct current stimulation (tDCS)
16107146|NCT02110407|Behavioral|training|intensive training of visual-spatial abilities (in LOCATO task)
16107147|NCT02110394|Other|bendamustine|Routine practice
16107148|NCT02110394|Other|rituximab|Routine practice
16107149|NCT02110381|Device|Device guided breathing RESPeRATE|"Participants will use a device called RESPeRATE which will measure how many breaths they take per minute. A strap wraps around the participants chest that measures breathing frequency. Headphones plug into the device to inform participants about their breathing. The device will help guide participants to breathe slowly using musical tones, with a goal of about ten breaths per minute.
~Participants will use the breathing device 5 days per week for about 15 minutes each day. Participants will keep a log of their exercises and return it with each visit."
16107150|NCT02110381|Device|Isometric hand grip Zona Plus|"Participants will use a device called the Zona Plus, which they will hold in their hand and squeeze. A session consists of 2 minutes of squeezing the device followed by 1 minute of rest. Participants will do a total of 4 sessions (2 sessions for each hand) for a total of about 12 minutes of exercise.
~Participants will do these exercises 5 days per week. Participants will keep a log of their exercise and return it with each visit."
16107151|NCT02110368|Drug|Testosterone Topical Gel, 1.62% Metered Pump|
16107152|NCT02110368|Drug|AndroGel (testosterone gel) 1.62% Metered-Dose Pump|
16107153|NCT02110355|Drug|AMG 232|Given as an oral tablet in escalating doses
16107154|NCT02110355|Drug|Trametinib|Trametinib is an anti-cancer agent
16107155|NCT02110355|Drug|Dabrafenib|Dabrafenib is an anti-cancer agent
16107156|NCT02110342|Drug|[14C] PF-04449913|Single oral dose of 100 mg PF-04449913 + 100µCi of [14C] PF-04449913
16107157|NCT02110329|Genetic|evaluation of the recurrence rate according to molecular analysis|
16107158|NCT02110316|Other|Dosage form of voriconazole|Instead of an oral dose of voriconazole, patients receive one intravenous dose of voriconazole (in the same dose as the oral dose).
16107159|NCT02110303|Drug|Ticagrelor|oral, 90mg tablets, twice daily, 12 month duration
16107160|NCT02110303|Drug|Placebo|Oral tablet (identical to ticagrelor), twice daily, 12 month duration
16107161|NCT02110277|Device|PAI/ultrasound Diagnostic Group|These patients will include women who are at risk for ovarian cancer and wish to undergo prophylactic oophorectomy, or who have an ovarian mass suggestive of a malignancy and are counseled to undergo oophorectomy.
16107162|NCT02110264|Drug|XR-NTX|Monthly injections of XR-NTX will be administered to participants assigned to either the XR-NTX or XR-NTX+PN groups.
16107163|NCT02110264|Behavioral|XR-NTX+PN|In addition to long-acting naltrexone (XR-NTX), participants assigned to the XR-NTX+PN condition will meet regularly with a patient navigator to assist in accessing psychosocial services when released from jail.
16107164|NCT02110264|Behavioral|ETAU|Participants assigned to the ETAU group will receive drug education.
16107165|NCT02110251|Behavioral|Supervised Exercise Therapy|
16107166|NCT02110238|Device|Supartz|Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
16107167|NCT02110238|Device|Euflexxa|Treatment is 3 injections over 2 weeks; Week 0 (baseline), Week 1, and Week 2.
16107168|NCT02110225|Drug|rhNGF 60 µg/ml eye drops solution|rhNGF 60 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes
16107169|NCT02110225|Drug|rhNGF 180 µg/ml eye drops solution|rhNGF 180 µg/ml eye drops solution, one drop 3 times a day for 24 weeks in both eyes
16107170|NCT02110225|Drug|Placebo|Placebo eye drops solution, one drop 3 times a day for 24 weeks in both eyes
16107171|NCT02110212|Procedure|U/S Surgery and CCC|Subjects will receive the standard of care for U/S cataract surgery and CCC to facilitate removal of the crystalline lens.
16107172|NCT02110212|Device|FS Laser Surgery|The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery.
16107173|NCT02110186|Device|Dynamic Stabilization|
16107174|NCT02110186|Procedure|Discectomy|
16107175|NCT02110186|Device|Instrumentation and fusion|
16107176|NCT02110147|Drug|uridine triacetate|
16107177|NCT02110134|Device|Revlite Laser System with hydroquinone skin care regimen|Revlite Laser System with hydroquinone skin care regimen for the Treatment of Melasma
16107178|NCT02110134|Other|Hydroquinone skin care regimen|Hydroquinone skin care regimen for the Treatment of Melasma
16107179|NCT02110121|Device|Picosure Laser System|Picosure Laser System for the Treatment of Unwanted Tattoos
16107180|NCT02110121|Device|Revlite Laser System|Revlite Laser System for the Treatment of Unwanted Tattoos
16107308|NCT02109185|Drug|Nasonex® Nasal Spray, 50 μg/actuation|
16107185|NCT02110069|Drug|Vincristine|Vincristine dose dependent upon weight. Weekly for 2 months (Induction); Weekly 2 months; every 2 weeks for next 5 months; every 3 weeks for 5 months (Maintenance)
16107186|NCT02110069|Drug|Sirolimus|Continuous dosing to maintain trough level of 10-15ng/ml.
16107187|NCT02110056|Device|tDCS|transcranial direct current stimulation (tDCS)
16107188|NCT02110056|Behavioral|training|intensive training of visual-spatial abilities (in LOCATO task)
16107189|NCT02110043|Device|tDCS|transcranial direct current stimulation (tDCS)
16107190|NCT02110043|Behavioral|training|intensive training of visual-spatial abilities (in LOCATO task)
16107191|NCT02110030|Device|Transcutaneous nerve stimulation|"The group with TENS received electrical stimulation (Endomed 182, Enraf-nonius, Germany) at a frequency of 80 Hz and with a pulse width of 150 ns. The TENS was applied by using 4 surface electrodes (5x5 cm Prim-Trode, Spain) into two channels: supraspinatus fossa and the insertion of the rotator cuff (channel 1) and V deltoid  (channel 2). The current intensity was set 3 times during each session according to each patient's sensitivity. Current was strong but it did not exceed the threshold of pain."
16107192|NCT02110030|Device|Interferential Currents|"The group with IC received a base frequency of 4000 Hz (Endomed 182, Enraf-nonius, Germany) with an amplitude-modulated frequency (AMF) and slope of 1/1 in tetrapolar mode, as previously indicated. For IC, the same number and type of surface electrodes (5x5 cm Prim-Trode, Spain) were placed onto the anterior and posterior deltoid, supraspinatus fossa and V deltoid. Similarly, the intensity of the current was set 3 times per session and the stimulation was strong but comfortable (without exceeding the threshold of pain)."
16107193|NCT02110017|Other|fMRI social cognition task|fMRI social cognition task : each subject will go through 3 runs of a fMRI paradigm, first one verbal then two visual runs, which are meant to activate the theory of mind network.
16107194|NCT02110004|Procedure|Ablation procedure|The primary purpose of the First-In-Man clinical investigation is to assess the Picasso NAV Catheter's ability to collect intra-cardiac signals within the desired chambers (atrial and/or ventricle) in the heart for the analysis of complex arrhythmias.
16107195|NCT02110004|Device|Picasso NAV Catheter|
16107196|NCT02109991|Device|CG-100 device|Colorectal surgery performed per standard of care with deployment of the CG-100 device in the anastomosis site
16107197|NCT02109965|Drug|Dexmedetomidine|Continue infusion (CIF) 0.1 - 0.7 mcg/kg/h Goal of sedation: Richmonad agitation-sedation scale 0 to -2
16107198|NCT02109965|Drug|Midazolam|CIF Goal of sedation: Richmonad agitation-sedation scale 0 to -2
16107199|NCT02109965|Drug|Propofol|CIF Goal of sedation: Richmonad agitation-sedation scale 0 to -2
16107200|NCT02109939|Genetic|GeneSight Psychotropic|"The GeneSight Psychotropic product is a pharmacogenomic decision support tool that helps clinicians to make informed, evidence-based decisions about proper drug selection, based on the testing for clinically important genetic variants in multiple pharmacokinetic and pharmacodynamic genes that affect a patient's ability to tolerate or respond to medications.
~The GeneSight Psychotropic product contains the most commonly prescribed antidepressant and antipsychotic medications, including a full representation of the SSRI and SNRI drug classes.
~tricyclic antidepressants, an MAOI, and typical and atypical antipsychotics are also represented."
16107201|NCT02109926|Other|Phone interview and blood test|Subjects will be interviewed about environmental, domestic and occupational exposures during several periods of life Two blood samples will be collected at enrollment to study genetic polymorphisms
16107202|NCT02109913|Drug|Everolimus plus Exemestane|Everolimus 10mg, oral, daily; exemestane 25 mg, oral, daily. Number of Cycles: until progression or unacceptable toxicity develops. From all patients, 4 additional blood samples, 6ml each, will be collected and an optional tumor biopsy will be taken, if eligible.
16107203|NCT02109900|Other|Serum Progesterone Levels|
16107204|NCT02109874|Biological|AERAS-404 (mcg H4/nmol IC31)|Dose escalation
16107205|NCT02109874|Biological|Sterile buffer containing 10 mmol/L tris and 169 mmol/L NaCl|
16107206|NCT02109861|Drug|Melphalan|A microdose of 2 mg/m2 iv Melphalan (1% of standard dose) is given two hours prior to planned standard dose Melphalan
16107207|NCT02109861|Drug|Bortezomib|A microdose of 0.013 mg/m2 iv Bortezomib (1% of standard dose) is given two hours prior to planned standard dose Bortezomib
16107208|NCT02109861|Drug|Dexamethasone|A microdose of 0.4 mg iv Dexamethasone (1% of standard dose) is given two hours prior to planned standard dose of Dexamethasone
16107209|NCT02109809|Radiation|total nodal irradiation|Undergo TLI
16107210|NCT02109809|Other|laboratory biomarker analysis|Correlative studies
16107211|NCT02109809|Other|questionnaire administration|Ancillary studies
16107212|NCT02109796|Device|transcranial Direct current stimulation|
16107213|NCT02109783|Dietary Supplement|Caffeine 2mg|Caffeine 2 mg versus 4 mg/kg or placebo
16107214|NCT02109783|Dietary Supplement|Caffeine 4 mg|To compare exercise performance of 2 or 4 mg of caffeine per kilogram of body weight to placebo within subjects. Subjects will perform 4 exercise tests.
16107215|NCT02109783|Dietary Supplement|Caffeine 0|To compare exercise performance of 2 or 4 mg of caffeine per kilogram of body weight to placebo within subjects. Subjects will perform 4 exercise tests.
16107216|NCT02109757|Other|Software intervention and education|Personal attenuation rating measurements will be taken before and after educating the patient using software program
16107217|NCT02109757|Other|Education only|
16107218|NCT02109744|Drug|Decitabine|
16107219|NCT02109731|Other|Negative airway pressure delivery|Negative airway pressure delivery (breathing against a vaccuum) in order to improve the tone of the upper airway muscles and make them less susceptible to collapse during sleep.
16107220|NCT02109718|Drug|Open Dressings with Petrolatum Jelly|participants randomized to this arm had their wounds dressed with a thin layer (1mm) of petrolatum gel applied over the burn wound and instructed to reapply the gel as needed in the event of gel coming off.
16107221|NCT02109718|Drug|Silver Sulfadiazine Gauze Dressing Group|Participants randomized to this arm had their wounds dressed using the standard methods at the Burn Center. An initial layer of fine mesh gauze is applied that is laden with a 2mm layer of silver sulfadiazine cream. This is covered with layers of moist gauze and an outer layer of dry gauze, secured by wrapping with rolled gauze. The dressing extends at least 1 inch beyond the wound edge.
16107222|NCT02109692|Other|blood sample|dosage of miRNA
16107223|NCT02109679|Drug|metformin|multiple doses metformin given as tablet
16107224|NCT02109679|Drug|BI 187004|multiple doses BI 187004 given as tablets
16107225|NCT02109679|Drug|BI 187004|multiple doses BI 187004 given as tablets
16107226|NCT02109679|Drug|metformin|multiple doses metformin given as tablet
16107227|NCT02109666|Drug|Abatacept|
16107228|NCT02109653|Drug|LGX818|Oral LGX818 300mg daily
16107229|NCT02109640|Drug|Targinact|Post-operative analgesia
16107230|NCT02109640|Drug|Oxycodone|Postoperative analgesia
16107231|NCT02109640|Procedure|Laparoscopic segmental colectomy|
16107232|NCT02109627|Drug|Ficlatuzumab|5-20 mg/kg; intravenous; Days 0, 14, 28, and 42. Number of cycles: until progression or unacceptable toxicity develops.
16107233|NCT02109627|Drug|Cytarabine|2 g/m2; intravenous; Days 2-7; Number of cycles: until progression or unacceptable toxicity develops.
16107234|NCT02109614|Drug|Extended release Niacin|Arm will be taking 1500-2000mg of niacin daily to see if lipoprotein(a) levels are lowered and aortic stenosis does not increase.
16107235|NCT02109614|Drug|Placebo Comparator|Placebo Comparator arm will be taking 1500mg of the placebo daily
16107236|NCT02109601|Other|Extensive bedside training for accessing patient portal|EXTENSIVE bedside training from a research assistant on how to access and effectively use their patient portal.
16107237|NCT02109601|Other|Limited bedside training on patient portal use.|EXTENSIVE bedside training from a research assistant on how to access and effectively use their patient portal.
16107238|NCT02109588|Behavioral|A supervised physical exercise program|"Supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training
~Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60% of heart rate reserve. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate"
16107239|NCT02109575|Diagnostic Test|Blood Draw of up to 10 ml|In a laboratory setting, the blood will be spun for plasma and buffy coat, DNA will be extracted for processing using the diagnostic test. The results of the test are not provided back to the clinical setting.
16107240|NCT02109562|Drug|RBP-7000|RBP-7000 90 mg and 120 mg were a mixture of the ATRIGEL Delivery System and 90 mg and 120 mg risperidone, respectively. The ATRIGEL Delivery System allows for sustained-release of risperidone in a controlled manner. Subcutaneous RBP-7000 injections on Days 1 and 29 in the lower quadrant of the abdomen rotating right and left on day 1 and 29.
16107241|NCT02109562|Drug|Placebo|Subcutaneous injection of placebo using the ATRIGEL Delivery System on Days 1 and 29 in the lower quadrant of the abdomen rotating right and left on day 1 and 29.
16107242|NCT02109562|Drug|Risperidone|Oral risperidone 0.25 mg tablets daily for the first two days of the screening period. The two 0.25 mg tablets confirmed whether study participants had any negative reaction to risperidone prior to receiving a long-acting injection of risperidone (RBP-7000).
16107243|NCT02109536|Device|Magnetic endoscopic imager.|recognizing loop type accuracy of loop type detection methods of loop reduction assessed by type
16107244|NCT02109523|Behavioral|Motivational Interviewing (MI|Five weekly motivational and volitional session sessions and each last about 50 minutes. Five registered psychologists will moderated the session. All MI technique and planing intervention will be used.
16107245|NCT02109523|Behavioral|volitional intervention|Five weekly motivational and volitional session sessions and each last about 50 minutes. Five registered psychologists will moderated the session. All MI technique and planing intervention will be used.
16107246|NCT02109523|Behavioral|Routine discharge counseling|
16107247|NCT02109510|Drug|nonintubated sedation anesthesia with dexmedetomidine IV, ketamine IV and intercostal nerve block with lidocaine infiltration|
16107248|NCT02109510|Drug|intubated general anesthesia with propofol IV, rocuronium IV ,sevoflurane and N2O gas|
16107249|NCT02109510|Procedure|single port thoracoscopic bullectomy|Thoracoscopic bullae resection with automated stapler through the single incision (2.0 cm length) at 5th intercostal space.
16107250|NCT02109497|Drug|PBT2|PBT2 250 mg administered
16107251|NCT02109484|Biological|P2-VP8 Subunit Vaccine 10mcg|10 mcg
16107252|NCT02109484|Biological|P2-VP8 Subunit Vaccine 30 mcg|30 mcg
16107253|NCT02109484|Biological|P2-VP8 Subunit Vaccine 60mcg|60 mcg
16107254|NCT02109484|Other|Placebo|
16107255|NCT02109458|Device|Navigation guided bronchoscopy|Navigation guided transthoracic needle aspiration (N-TTNA) and navigation guided bronchoscopy (NB); guidance system is by Veran Medical Technologies, Inc.
16107256|NCT02109445|Drug|PF-03084014|Tablets, orally administered twice daily on a continuous dosing schedule in 28 days cycles. Doses: 100 -150 mg BID
16107257|NCT02109445|Drug|Gemcitabine|Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 1000 mg/m2.
16107258|NCT02109445|Drug|Nab-paclitaxel|Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 125 mg/m2.
16107259|NCT02109445|Drug|PF-03084014|Tablets, orally administered twice daily on a continuous dosing schedule in 28 days cycles. Phase 2 dose will be the recommended phase 2 dose defined in phase 1.
16107260|NCT02109445|Drug|Gemcitabine|Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 1000 mg/m2.
16107261|NCT02109445|Drug|Nab-paclitaxel|Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 125 mg/m2.
16107262|NCT02109445|Drug|Gemcitabine|Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 1000 mg/m2.
16107263|NCT02109445|Drug|Nab-paclitaxel|Intravenously administered on Days 1, 8, 15 in 28 days cycles at the dose of 125 mg/m2.
16107264|NCT02109432|Behavioral|Self-Directed Pedal Desk|participants will have a pedal desk installed in their office and will have access to their daily recorded data but will not have any other form of feedback or goal-setting
16107265|NCT02109432|Behavioral|Facilitated Pedal Desk|participants are provided with their daily recorded pedal desk data and additional daily behavioral support from an interventionist (e.g., feedback and goal-setting) to increase their use of the pedal desk by an individually negotiated and agreed upon amount
16107309|NCT02109185|Drug|Nasonex® Nasal Spray Suspnsn, 50 μg/actuation|
16107310|NCT02109185|Drug|Placebo Nasal Spray, 50 μL/actuation|
16107311|NCT02109172|Drug|TD-4208|
16107312|NCT02109172|Drug|Placebo|
16107266|NCT02109432|Behavioral|Facilitated Pedal Desk with Pedometer|participants will be provided with their daily recorded pedal desk and step count data and additional daily behavioral support from an interventionist (e.g., feedback and goal-setting) to increase their use of the pedal desk by an individually negotiated and agreed upon amount and increase their step count by 3,000 steps/day compared to baseline.
16107267|NCT02109419|Other|HHT-G|Helping Hands Technology global cognitive function assessment
16107268|NCT02109419|Other|HHT-D|Helping Hands Technology depression assessment
16107269|NCT02109419|Other|Geriatric Depression Scale (DGS)|Geriatric Depression Scale (DGS)
16107270|NCT02109419|Other|MMSE|Mini Mental State Exam
16107271|NCT02109406|Drug|AZD2115 Dose 1|AZD 2115, Dose 1 administered as two inhalations BID
16107272|NCT02109406|Drug|AZD 2115, Dose 2|AZD 2115, Dose 2 administered as two inhalations BID
16107273|NCT02109406|Drug|Placebo MDI|Placebo MDI administered as two inhalations BID
16107274|NCT02109393|Other|MIRT|"It consists of a 4-weeks physical therapy which entails four daily sessions for five days. All treatments are performed in aerobic condition. The duration of each session, including recovery periods, is about one hour. The first session consists of a one-to-one session with physical therapist. The second session includes aerobic and repetitive exercises to improve balance and gait using different devices: a posturographic platform with visual cues, cycloergometer, treadmill-plus. The third is a session of occupational therapy. The last session includes one hour of speech therapy.
~All patients undergo 20-minutes treadmill-plus training per day, 5 times a week, for 4 weeks."
16107275|NCT02109393|Other|MIRT+Lokomat|It consists of a 4-weeks physical therapy which entails four daily sessions for five days. All treatments are performed in aerobic condition. The duration of each session, including recovery periods, is about one hour. The first session consists of a one-to-one session with physical therapist. The second session includes aerobic and repetitive exercises to improve balance and gait using different devices: a posturographic platform with visual cues and cycloergometer. The third is a session of occupational therapy to improve autonomy in activities of daily life. The last session includes one hour of speech therapy. All patients undergo 20-minutes Lokomat® training per day in spite of treadmill-plus.
16107276|NCT02109380|Behavioral|Bed rest|
16107277|NCT02109354|Biological|ALVAC-HIV|Formulated as a lyophilized vaccine for injection and is reconstituted with 1.05 mL of sterile Sodium Chloride solution (0.4% NaCl) for a single 1 mL dose of >1.0 x 106 CCID50/mL, to administer intramuscularly (IM).
16107278|NCT02109354|Biological|AIDSVAX B/E|300 mcg of subtype B (MN) HIV gp120 glycoprotein and 300 mcg of subtype E (A244) HIV gp120 glycoprotein adsorbed onto 600 mcg of aluminum hydroxide gel adjuvant. Each vial contains 1.2 mL of sterile suspension, to administer 1 mL IM.
16107279|NCT02109354|Biological|Placebo for ALVAC-HIV|A sterile, lyophilized product that consists of a mixture of virus stabilizer, and freeze drying medium and is reconstituted with 1.05 mL of sterile Sodium Chloride (0.4% NaCl) for a single 1 mL dose, to administer IM.
16107280|NCT02109354|Biological|Placebo for AIDSVAX B/E|Sodium Chloride for Injection, 0.9% administered IM.
16107281|NCT02109354|Biological|Hepatitis B vaccine|Each 1 mL dose contains 20 mcg of hepatitis B surface antigen (HBsAg) adsorbed onto 500 mcg aluminum as aluminum hydroxide, to administer IM.
16107282|NCT02109354|Biological|Tetanus toxoid vaccine|The active ingredient is tetanus toxoid (≥ 40 I.U. / 0.5 mL) adsorbed on aluminium hydroxide dihydrate (600 mcg of aluminium), to administer IM.
16107283|NCT02109354|Biological|Placebo for hepatitis B vaccine|Sodium Chloride for Injection, 0.9% administered IM.
16107284|NCT02109354|Biological|Placebo for tetanus vaccine|Sodium Chloride for Injection, 0.9% administered IM.
16107285|NCT02109341|Drug|Paclitaxel bound albumine|
16107286|NCT02109328|Drug|Alisertib|"SINGLE-ARM, SINGLE-DRUG PHASE: Alisertib will be given PO in a dosage of 50 mg BID for 7 Days (Days 1-7) of each 21 day treatment cycle.
~In the randomized phase, Experimental arm will consist of the following drugs:
~Alisertib will be given PO in a dosage of 40 mg twice daily on days 1-3, 8-10 and 15-17 of a 28 day cycle.
~Paclitaxel: 60 mg/m2 over 60 minutes on Days 1, 8, and 15 in a 28-day cycle."
16107287|NCT02109328|Drug|Paclitaxel|Placebo will be given PO. Paclitaxel will be infused at the dose of 80 mg/m2 IV over a period of 60 minutes on Days 1, 8, and 15 in a 28-day cycle.
16107288|NCT02109328|Drug|Placebo|Placebo oral tablets
16107289|NCT02109315|Drug|Vitamine C|C Vitamine endovenous 1000 mg/5 ml. Infusion dose: 30 mgr/min
16107290|NCT02109315|Drug|Liraglutide 6 mg|Liraglutide endovenous de 0.6 mg. one time a day
16107291|NCT02109302|Procedure|Blood sample|
16107292|NCT02109302|Procedure|Skin biopsy|
16107293|NCT02109302|Other|Questionnaire|
16107294|NCT02109289|Drug|etanercept|Etanercept is a tumor necrosis factor antagonist
16107295|NCT02109276|Device|Spheric Sensar(R) 3-piece IOL|Patients will be randomized to receive either a standard spheric intraocular lens or an aspheric intraocular lens
16107296|NCT02109276|Device|Aspheric Tecnis(R) 3-piece IOL|Patients will be randomized to receive either a standard spheric intraocular lens or an aspheric intraocular lens
16107297|NCT02109263|Procedure|saccharose versus breast-feeding|saccharose versus breast-feeding
16107298|NCT02109250|Drug|Caprelsa|Caprelsa® 100 mg or 300 mg film-coated oral tablets. Each film-coated tablet contains 100 mg or 300 mg of vandetanib.
16107299|NCT02109237|Procedure|Assessment of sleep disorders and treatment if required|Assessment of sleep disorders and treatment if required
16107300|NCT02109224|Drug|Ibrutinib|Given PO
16107301|NCT02109224|Other|Laboratory Biomarker Analysis|Correlative studies
16107302|NCT02109224|Other|Pharmacological Study|Correlative studies
16107303|NCT02109211|Device|Intubation with Magill forceps|
16107304|NCT02109211|Device|Intubation with altered Magill forceps|
16107305|NCT02109198|Device|Active CN-NINM PoNS|Delivery of active stimulation of the tongue during in-person therapy sessions (1 hour) and during two home sessions (40 minutes) daily on 6 of 7 days per week (120 total sessions). Stimulation sessions will be separated by at least 4 hours.
16107306|NCT02109198|Device|Sham CN-NINM PoNS|Delivery of sham stimulation of the tongue during in-person therapy sessions (1 hour) and during two home sessions (40 minutes) daily on 6 of 7 days per week (120 total sessions). Stimulation sessions will be separated by at least 4 hours.
16107307|NCT02109185|Drug|Mometasone Furoate Monohydrate Nasal Spray, 50 μg/act.|
16107315|NCT02109146|Drug|Transcatheter Arterial Chemoembolization|Transcatheter Arterial Chemoembolization should be used in the experimental group
16107316|NCT02109146|Other|No intervention No Transcatheter Arterial Chemoembolization|
16107317|NCT02109133|Procedure|deep neuromuscular blockade|deep neuromuscular blockade using rocuronium and reverse with sugammadex
16107318|NCT02109133|Procedure|moderate neuromuscular blockade|moderate neuromuscular blockade using atracurium and reverse with neostigmine
16107319|NCT02109133|Drug|Rocuronium|
16107320|NCT02109133|Drug|Sugammadex|
16107321|NCT02109133|Drug|Atracurium|
16107322|NCT02109133|Drug|Neostigmine|
16107323|NCT02109120|Procedure|vein blood collection|5 ml peripheral vein blood samples were collected from each patient admitted to our study at the following time-points：Pre-operative（morning of surgery），just before declamping，30mins after declamping and post-operative（12h）.
16107324|NCT02109107|Device|Erchonia EZ6 Laser|The Erchonia EZ6 is administered 6 times across 6 consecutive weeks, each administration seven days apart, each treatment lasting 60 minutes.
16107325|NCT02109081|Drug|Dexamethasone|
16107326|NCT02109081|Drug|Placebo|
16107327|NCT02109068|Behavioral|Weight Loss Counseling- Phone|"The intervention will be based on the Diabetes Prevention Program weight loss program, which uses a combination of reduced caloric intake, increased physical activity, and behavior therapy. The content of the weight loss program will be similar for the in-person and telephone interventions, but the approach will vary (i.e., in-person vs. telephone counseling). The weight loss intervention will be conducted by a Registered Dietitian, who has training in exercise physiology and behavior modification.
~During the 6-month intervention, participants will receive weekly (month 1), then bi-weekly (months 2 and 3), then monthly (months 4, 5, and 6) individualized counseling sessions. An advantage of tapering the frequency of visits from weekly to every other week and then monthly works as a process tool to help transfer the work or responsibility onto the participant for life long change and maintenance of behavior change."
16107328|NCT02109068|Behavioral|Weight Loss Counseling- In-Person|"The intervention will be based on the Diabetes Prevention Program weight loss program, which uses a combination of reduced caloric intake, increased physical activity, and behavior therapy. The content of the weight loss program will be similar for the in-person and telephone interventions, but the approach will vary (i.e., in-person vs. telephone counseling). The weight loss intervention will be conducted by a Registered Dietitian, who has training in exercise physiology and behavior modification.
~During the 6-month intervention, participants will receive weekly (month 1), then bi-weekly (months 2 and 3), then monthly (months 4, 5, and 6) individualized counseling sessions. An advantage of tapering the frequency of visits from weekly to every other week and then monthly works as a process tool to help transfer the work or responsibility onto the participant for life long change and maintenance of behavior change."
16107329|NCT02109055|Other|Pilates|The exercise program will be held during the period of hospitalization for six days, often two to three sessions per day, totaling 12 sessions.
16107330|NCT02109055|Other|Conventional Physiotherapy|The conventional physiotherapy group will continue with the routine hospital consisting of respiratory physiotherapy, twice daily, six days.
16107331|NCT02109042|Drug|Blosozumab|Administered subcutaneously
16107332|NCT02109029|Drug|Insulin Peglispro|Administered IV
16107333|NCT02109029|Drug|Human Insulin|Administered IV
16107334|NCT02109016|Drug|Lucitanib|"Lucitanib given orally to all patients, once daily (q.d.), on a continuous schedule over 28-day cycles, in fasting conditions (at least 2 hours prior to and 2 hours after any meal), until progressive disease or unacceptable toxicity.
~Starting dose is 10 mg/day and can be reduced in 2.5 mg decrements to 5 mg/day based on individual tolerability."
16107335|NCT02109003|Device|Pressure easy® device|Continuous control of tracheal cuff pressure using a mechanical device for 24h followed by manual control of cuff pressure using a manometer.
16107336|NCT02109003|Device|Manual control of Pcuff followed by continuous control.|Control 24h with manual control using a manometer followed by 24h of continuous control using a mechanical device.
16107337|NCT02108990|Drug|Acetaminophen|
16107338|NCT02108977|Other|Videoconferencing Genetic Consultation|Patients will travel to CBOC and receive genetic counseling session via videoconferencing
16107339|NCT02108977|Other|Teleconferencing Genetic Consultation|Patients will receive genetic counseling session via telephone (usual treatment)
16107340|NCT02108964|Drug|EGF816|EGF816 will be dosed once daily. On the first day of each treatment cycle, the patient receives an adequate drug supply for self-administration at home. The investigator will instruct the patient to take EGF816 exactly as prescribed.
16107341|NCT02108951|Drug|Nilotinib|Nilotinib 150mg hard gelatin capsules taken orally
16107342|NCT02108925|Drug|Oxygen|supplementary oxygen during exercise
16107343|NCT02108912|Other|ESTT|ESTT is early-standardized task-specific training is a treadmill and over ground gait protocol for gait recovery after stroke
16107344|NCT02108912|Other|Traditional outpatient|Traditional physical therapy includes standard of care for gait recovery after stroke such as pre-gait activities, standing balance activities, strengthening, walking with assistive devices.
16107345|NCT02108899|Behavioral|Retrieval practice effect using descriptive stories and free-call tests without feedback|"In the first phase (encoding), people study 2 short prose passages covering general scientific topics.
~In the second phase (initial test), they recall one text or restudy the other one.
~In the third phase (final test) which takes place 2 days later, they recall both texts."
16107346|NCT02108886|Drug|Montelukast|10 mg of Montelukast per day, from admission for preterm labor until delivery or 35 weeks of pregnancy.
16107347|NCT02108886|Drug|Placebo|empty capsule filled with sugar
16107348|NCT02108886|Other|urine and vaginal secretions sampling|Urine and vaginal secretions sampling, once a week in both groups
16107349|NCT02108860|Drug|Abatacept|Those randomized to abatacept will receive abatacept 125 mg administered by subcutaneous injection once a week Participants randomized to either the abatacept or the placebo arm who experience a non-severe disease relapse, non-severe disease worsening, or who have not achieved remission by month 6 will have the option of entering an open-label trial period whereby they would receive open-label abatacept. .
16107350|NCT02108860|Drug|placebo|Those randomized to placebo will receive a sterile placebo solution administered by subcutaneous injection once a week.
16107351|NCT02108847|Drug|.2% Ropivacaine|
16107353|NCT02108847|Procedure|Fascia Iliaca Block|Ultrasound-guided regional anesthesia block to the groin area.
16107354|NCT02108834|Procedure|nerve block|After general anaesthesia,the patient is placed in a supine position with the head turn away from the side to be blocked, and then the sternocleidomastoid muscle (SCM) is identified by slight head elevation. SCPB(superficial cervical plexus block) is performed with a 26-gauge needle that is inserted at the midpoint of the posterior border of the SCM muscle and the needle is advanced just past the SCM muscle. The mixture is prepared with 20ml of 0.5% ropivacaine in Group 1
16107355|NCT02108834|Procedure|placebo|After general anaesthesia,the patient is placed in a supine position with the head turn away from the side to be blocked, and then the sternocleidomastoid muscle (SCM) is identified by slight head elevation. SCPB(superficial cervical plexus block) is performed with a 26-gauge needle that is inserted at the midpoint of the posterior border of the SCM muscle and the needle is advanced just past the SCM muscle. The mixture is prepared with 20ml of 0.9% saline in Group 2.
16107356|NCT02108821|Biological|Fecal Microbiota Transplantation (FMT)|The process of fecal microbiota transplantation (FMT), where fecal bacteria from a healthy individual is transferred into a recipient as an alternative therapy for individuals affected with these life-altering diseases: Crohn's Disease (CD), and/or Ulcerative Colitis (UC).
16107357|NCT02108808|Drug|Ticagrelor|
16107358|NCT02108808|Drug|Prasugrel or Clopidogrel|
16107359|NCT02108795|Drug|Remifentanil|Children randomised to remifentanil group receive remifentanil 0.05 ug/kg/min. Children randomised to control group receive normal saline (placebo)
16107360|NCT02108795|Drug|Placebo|
16107361|NCT02108782|Drug|dovitinib lactate|Given PO
16107362|NCT02108782|Other|pharmacological study|Correlative studies
16107363|NCT02108782|Other|laboratory biomarker analysis|Correlative studies
16107364|NCT02108769|Behavioral|Yogic Breathing|"Chanting Om
~Sharp deep inhalation through nostrils
~Slow exhalation through mouth while chanting Om. At this step the subjects will perform a slow and complete exhalation.
~Repeat for 10 min. During the whole period of chanting, the subjects keep their eyes closed.
~Yogic Breathing:
~Check which of the two nostrils exhibit free flow of air. For the explanation purpose the nostril with free flow of air is treated as Nostril 1 and the other one as Nostril 2.
~Close Nostril 2 and inhale a sharp deep breath through Nostril 1 and then close both the nostrils so no inhaled air escapes. Air should not escape through mouth either. This inhalation step should take about 4 seconds.
~Hold breath in this position for about 16 seconds.
~Open Nostril 2 and exhale for about 8 seconds. Complete exhalation is required. Abdomen will slowly curve-in as the subject exhales. This is normal and encouraged. No air should leak through the Nostril 1 or mouth.
~Go to step a)."
16107365|NCT02108769|Behavioral|Attention Control|The participants will read a text of their choice for 20 minutes in a one-on-one session with the Yoga Instructor.
16107366|NCT02108756|Drug|L-pantoprazole sodium|2 injection L-pantoprazole sodium (40mg), Bid
16107367|NCT02108756|Drug|Panmeilu|An injection Panmeilu (80 mg) + 1 branch placebo, Bid;
16107368|NCT02108743|Drug|Albuterol.|2.5 mg of albuterol inhaled via jet nebulizer 15 minutes prior to symptom-limited maximal CPET.
16107369|NCT02108743|Drug|Normal saline placebo|Placebo inhaled via jet nebulizer 15 minutes prior to symptom-limited maximal CPET.
16107370|NCT02108730|Procedure|restrictive pancreatic resection|Restrictive, spleen-preserving resection of the pancreatic tail by laparoscopy
16107371|NCT02108717|Device|Remote CT reading using the iPhone|
16107372|NCT02108717|Device|CT reading using LCD monitor|
16107373|NCT02108704|Drug|Helicobacter pylori eradication therapy|
16107374|NCT02108704|Drug|Placebo|
16107375|NCT02108691|Dietary Supplement|Glycin max(L.) Merr. peel extract|Glycin max(L.) Merr. peel extract (2.5g/day)
16107376|NCT02108691|Dietary Supplement|Placebo|Placebo (2.5g/day)
16107377|NCT02108678|Behavioral|ACT-ME|1 hour discussion about migraine education (ME) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). Migraine education covers topics including migraine symptoms, triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations.
16107378|NCT02108678|Behavioral|Migraine Education Only|6 hour discussion of migraine education only (MEO). This will involve educating participants about migraine, its natural course, its prodromal symptoms and triggers for symptom worsening, risk for migraine chronification, how to use abortive migraine medications, medication overuse headache, medical and psychological treatments of migraine, migraine comorbidity, and menstrual migraine.
16107379|NCT02108665|Radiation|Radiographic hysterosalpingography|
16107380|NCT02108665|Radiation|Magnetic resonance imaging hysterosalpingography|
16107382|NCT02108639|Drug|DCV 3DAA FDC|
16107383|NCT02108639|Drug|BMS-791325|
16107384|NCT02108626|Drug|Nicotine|E-Cigarette with nicotine cartridge
16107385|NCT02108626|Drug|Placebo|E-Cigarette with 0mg nicotine cartridge
16107386|NCT02108613|Behavioral|Exercise Sessions|8 weeks of weekly exercise classes taught by a certified exercise physiologist.
16107387|NCT02108613|Behavioral|Nutrition Education|Four monthly education sessions on nutrition topics. Presentations and materials are were created by a BCCA dietitian.
16107388|NCT02108613|Behavioral|Peer Support Volunteer|Participants will be assigned a peer support volunteer who will preform adherence calls to discuss goals and motivations about improving exercise and healthy eating.
16107389|NCT02108600|Drug|Tocilizumab|Will receive tocilizumab 8 mg/kg intravenously at four-week intervals for a total of 6 doses. In addition, will continue usual immunosuppressive regimen.
16107390|NCT02108587|Device|optical coherence tomography|Undergo optical coherence tomography
16107391|NCT02108574|Device|Placebo Filter|
16107392|NCT02108574|Device|Rhinix Nasal Filter|
16107393|NCT02108561|Other|Post Surgical Her2 testing|Eligible patients will have post surgical Her2 testing on the primary tumor, a satellite lesion and a tumor positive node. The results will be provided to medical oncologist, who will comment as to whether the additional testing will prompt treatment recommendation changes
16107394|NCT02108548|Drug|ASP7657|oral
16107397|NCT02108535|Drug|Nanocrystalline silver|Flexible polyester low-grip coated nano-crystalline silver layer. The level of silver is 1.64 mg/ cm². This dressing enables the sustained release of silver in humid conditions dynamically and reached a higher plateau than 60 mg / L in less than 2 hours, and maintains a uniform level by 72 hours.
16107398|NCT02108535|Drug|Silver Sulfadiazine|This is at Standard treatment. The cream silver sulphadiazine at 1% was applied on the burn aseptically in a thick layer, approximately 3 to 5 mm, ie 5 g per 80 cm2
16107399|NCT02108522|Biological|Multivirus Specific T cells|
16107400|NCT02108496|Device|NUsurface® Meniscus Implant|The NUsurface Meniscus Implant is a Polycarbonate-Urethane (PCU)-based device reinforced with high tensile Ultra High Molecular Weight Polyethylene (UHMWPE) fibers. The product is available in different sizes, left and right, and with trials so as to allow the surgeon several size options for implantation. The NUsurface® Meniscus Implant, is designed to be conceptually analogous to the natural meniscus whose structural characteristics include a highly orientated collagen fiber network supports the large hoop stresses to produce better distribution of contact pressures within the knee joint. Restoring the distribution of joint loads post-meniscectomy is thought to reducing joint overload and to reducing pain.
16107401|NCT02108496|Drug|NSAID's and Non-surgical Treatment Options|Non-prescription drugs, creams, vitamins, and supplements, Prescription or Non-Prescriptions NSAIDs, Non-weight bearing and/or open chain physical therapy or self-administered exercise
16107402|NCT02108496|Drug|Intra-Articular Injections with Corticosteroids|Intra-articular injection of a corticosteroid, such as 40 mg of Triamcinolone (e.g. Aristocort or Kenalog).
16107403|NCT02108496|Drug|Intra-Articular Injections with Hyaluronic Acid (HA)|Intra-articular injection of a hyaluronic acid treatment, such as SYNVISC® HA Injections.
16107404|NCT02108483|Drug|dapsone gel|Patches containing dapsone gel will be applied to the skin.
16107405|NCT02108483|Drug|dapsone gel vehicle|Patches containing dapsone gel vehicle will be applied to the skin.
16107406|NCT02108470|Other|Dental consultation using OHIP|The S-OHIP[M] measure assesses the impact of one's oral health condition on QoL, contributing to 7 domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and handicap. Responses of each item are made on a Likert scale and coded as: 1 = never, 2 =hardly ever, 3= occasionally, 4= fairly often, and 5= very often.
16107407|NCT02108457|Radiation|[18F]Fluorothymidine (FLT) PET/CT Imaging|
16107408|NCT02108431|Device|balloon catheter for suprapubic bladder-drainage|suprapubic tube removal was allowed when the anastomosis was watertight, Day 5
16107409|NCT02108431|Device|balloon catheter for transurethral bladder-drainage|transurethral catheter withdrawal was allowed when the anastomosis was watertight, Day 5
16107410|NCT02108418|Drug|TG-2349 as the original formulation|single oral dose under fed condition
16107411|NCT02108418|Drug|TG-2349 as a new capsule formulation|single oral dose under fed condition
16107412|NCT02108379|Device|Rhinix Nasal Filters|
16107413|NCT02108366|Drug|Celecoxib|Celecoxib 200mg daily
16107414|NCT02108366|Drug|Oseltamivir|Oseltamivir 75mg bid
16107415|NCT02108366|Drug|Placebo|Placebo capsule identical in appearance to celecoxib capsule, containing corn starch
16107416|NCT02108353|Drug|Melatonin 2mg|once daily, 0.5-1 hours before going to bed and 1-2 hours after the last meal for 12 weeks.
16107417|NCT02108353|Drug|Placebo|once daily, 0.5-1 hours before going to bed and 1-2 hours after the last meal for 12 weeks.
16107418|NCT02108340|Procedure|Microwave radiometry|Microwave radiometry of the right lower quadrant in a room temperature of 20-24 degrees celsius, in order to record changes in the temperature of the inflamed appendix.
16107419|NCT02108327|Procedure|surgical blade|Using surgical blade all the time of surgery
16107420|NCT02108327|Procedure|electrocautery|Using electrocautery all the time except at skin incision
16107421|NCT02108314|Behavioral|Video Screening and Counselling|The intervention comprises 1) GP counseling, 2) 3-minute promotional video on mammography and 3) an informational brochure with relevant contact details and information for arranging a mammography screening. Pre- and post-consultation questionnaire were administered to participants to evaluate their health beliefs, with emphasis on breast cancer and mammography.
16107422|NCT02108301|Drug|tacrolimus-cyclosporine A|conversion of immunosuppression from tacrolimus to cyclosporine A in hepatitis C-positive renal transplant recipients
16107423|NCT02108288|Drug|OPC-1085EL ophthalmic solution|
16107424|NCT02108288|Drug|Carteolol long-acting ophthalmic solution|
16107425|NCT02108288|Drug|Latanoprost ophthalmic solution|
16107426|NCT02108262|Biological|CSL112|CSL112 is a novel formulation of apolipoprotein A-I (apoA-I) purified from human plasma and reconstituted to form high-density lipoprotein (HDL) particles.
16107427|NCT02108262|Biological|Placebo|0.9% weight/volume sodium chloride solution (ie, normal saline)
16107428|NCT02108249|Device|Annex™ Adjacent Level System|
16107429|NCT02108236|Device|acupuncture|Zhong-wan (RN12), Liang-men (ST21), Shui-fen (RN9) and Qi-hai (RN6) and bilateral acupuncture points Dai-mai (GB26), Tian-shu (ST25), Zu-sanli (ST36), Feng-long(ST40) and Liang-qiu(ST34) will be applied through the skin by acupuncture for 30 minutes every time. Electro-acupuncture apparatus will be connected to both Dai-mai, Zu-sanli and Feng-long, Zhong-wan and Qi-hai for 30 minutes with interrupted waves (2/100HZ).
16107430|NCT02108223|Drug|fix dose r-FSH (Gonal-f)|recombinant follicle stimulation
16107431|NCT02108223|Drug|r-LH supplementation|recombinant luteinizing hormone
16107432|NCT02108223|Drug|r-FSH (Gonal-f)|recombinant follicle stimulation hormone
16107433|NCT02108210|Drug|Anakinra|
16107434|NCT02108210|Drug|Placebo|
16107435|NCT02108197|Device|Continuous positive airway pressure (S9, ResMed)|
16107436|NCT02108184|Drug|Sequential therapy 10 days|(pantoprazole 40 mg + amoxicillin 1.0 g) bid for the first 5 days, subsequently (pantoprazole 40 mg + clarithromycin 500 mg + metronidazole 500 mg ) bid for the next 5 days : Sequential therapy 1
16107437|NCT02108184|Drug|Sequential therapy 14 days|(pantoprazole 40 mg + amoxicillin 1.0 g bid) for the first 7days, subsequently (pantoprazole 40 mg + clarithromycin 500 mg + metronidazole 500 mg bid) for the next 7 days : Sequential therpay 2
16107438|NCT02108184|Drug|Concomitant therapy 10 days|(pantoprazole 40 mg + amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg ) bid for 10 days : Concomitant therapy 1
16108270|NCT02101853|Drug|Cyclophosphamide|Given IV
16107439|NCT02108184|Drug|Concomitant therapy 14 days|(pantoprazole 40 mg +amoxicillin 1.0 g + clarithromycin 500 mg + metronidazole 500 mg bid) for 14 days : Concomitant therapy 2
16107440|NCT02108171|Drug|Dexmedetomidine|intranasal dexmedetomidine 1μg.kg-1，0.9% saline was added to make a final volume of 1 mL.all patients received intranasal medication at approximately 45-60 min before induction of anesthesia.
16107441|NCT02108171|Drug|placebo|0.9% saline 1 mL all patients received intranasal medication at approximately 45-60 min before induction of anesthesia.
16107442|NCT02108158|Drug|Azzalure|
16107443|NCT02108145|Procedure|bilateral metal stent insertion|
16107444|NCT02108145|Procedure|unilateral metal stent insertion|
16107445|NCT02108132|Biological|Cellular therapy|bone marrow derived mesenchymal stem cells for normal subjects will be separated and induced to adopt the hepatocyte phenotype then injected through the portal vein to hemophilia patients
16107446|NCT02108132|Biological|cellular therapy|Allogenic bone marrow derived MSCs will be isolated and subjected to induction of hepatic phenotype. After proof of in vitro secretion of albumin and factor 8 from the cell population. It will be injected into the portal vein via the spleen
16107447|NCT02108119|Dietary Supplement|Probiotics|
16107448|NCT02108119|Dietary Supplement|Control placebo|
16107449|NCT02108106|Drug|AG-348|A range of doses of AG-348 will be tested based on assessment of safety and tolerability.
16107450|NCT02108106|Drug|Placebo|
16107451|NCT02108093|Procedure|retrograde autologous priming|Retrograde autologous priming (RAP) is a technique where, the patient's own circulating blood partially replaces the priming solution in the CPB.
16107452|NCT02108054|Device|7T MRI|Modifying, refining, and verifying the feasibility and applicability of tasks for functional magnetic resonance imaging (fMRI) to measure intended concomitant brain activation
16107453|NCT02108015|Procedure|Brain Imaging (PET)|
16107454|NCT02108015|Procedure|Aterial Line|
16107455|NCT02108015|Procedure|Blood Sampling|
16107456|NCT02108002|Drug|Vorinostat|
16107459|NCT02107963|Biological|Anti-GD2-CAR engineered T cells|Administer anti-GD2 CAR T cells 1 x 105 transduced T cells/kg; 1 x 106 transduced T cells/kg; 3 x 106 transduced T cells/kg; and 1 x 107 transduced T cells/kg
16107460|NCT02107963|Drug|AP1903|If unacceptable toxicity occurs that is possibly, probably or likely related to anti-GD2-CAR T cells, AP1903, a dimerizing agent, may be administered to mediate clearance of the genetically engineered cells and resolve toxicity
16107461|NCT02107963|Drug|Cyclophosphamide|1800mg/m2/d X 2 days as a lymphodepleting regimen
16107462|NCT02107950|Biological|DCVAC/OvCa in parallel with chemotherapy|DCVAC/OvCa is the experimental therapy added on to Carboplatin and Gemcitabine
16107463|NCT02107950|Drug|Standard of Care|Carboplatin and Gemcitabine is Standard of Care First Line Chemotherapy
16107464|NCT02107937|Biological|DCVAC/OvCa with Standard of Care|DCVAC/OvCa is the experimental therapy added on to Carboplatin and Paclitaxel
16107465|NCT02107937|Biological|DCVAC/OvCa sequentially chemotherapy|DCVAC/OvCa added sequentially after Carboplatin and Paclitaxel
16107466|NCT02107937|Drug|Standard of Care|Carboplatin and Paclitaxel is Standard of Care First Line Chemotherapy
16107467|NCT02107924|Procedure|APPI of TKR-Stimulan|
16107468|NCT02107898|Drug|Placebo (for alirocumab)|Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with an auto-injector.
16107469|NCT02107898|Drug|Alirocumab|Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with an auto-injector.
16107470|NCT02107898|Drug|Lipid-Modifying Therapy (LMT)|Statin (pravastatin, simvastatin, fluvastatin, atorvastatin, pitavastatin, rosuvastatin) at stable dose with or without other LMT as clinically indicated.
16107471|NCT02107885|Drug|DS-1971|6 subjects in each group will receive DS-1971.
16107472|NCT02107885|Drug|placebo|2 subjects in each group will receive placebo.
16107473|NCT02107872|Drug|REGN1500|
16107474|NCT02107872|Drug|placebo|
16107475|NCT02107859|Drug|Ataluren|Ataluren will be administered per dose and schedule specified in the arm.
16107476|NCT02107846|Drug|PRX-112|
16107477|NCT02107833|Drug|OPRX-106|
16107478|NCT02107820|Behavioral|Bladder Training (BT)|All patients randomised to PTNS + BT group will have BT with the nurse for 20 minutes during PTNS sessions (which last 30 minutes). Since BT is recommended by NICE for a duration of 6 weeks. BT will be discussed for the first 6 sessions of the 12 week PTNS treatment cycle.
16107479|NCT02107820|Device|Percutaneous Tibial Nerve stimulation|"A needle electrode insertion site is located on the inner aspect of either leg approximately three fingerbreadths (5 cm or 2) cephalad to the medial malleolus and approximately one fingerbreadth (2 cm or ¾) posterior to the tibia. The needle electrode head is gently tapped to pierce the skin, maintaining a 60° angle, and insert to a depth of approximately 2cm. The electrode is then connected to the stimulator and the current setting needed is determined by the test mode on the stimulator. Once the current setting is known, the stimulator is started on the therapy mode which delivers the current for 30 minutes and shuts off automatically after 30 minutes. The needle is then removed and stimulator disconnected. The treatment involves twelve weekly sessions of 30 minutes each."
16107480|NCT02107807|Biological|Novartis Investigational H5N1 vaccine|2 doses of 0.5 ml, 3 weeks apart
16107481|NCT02107807|Biological|Novartis Investigational H5N1 vaccine|2 doses of 0.5 ml, 3 weeks apart
16107482|NCT02107807|Biological|Novartis Seasonal Influenza Vaccine|2 doses of 0.5 ml, 3 weeks apart
16107483|NCT02107807|Biological|Novartis Seasonal Influenza Vaccine|2 doses of 0.5 ml, 3 weeks apart
16107484|NCT02107794|Other|Decision Aid|Paper based decision aid will be utilized to facilitate treatment option conversation between clinician and patient.
16107485|NCT02107781|Device|AbViser abdominal compartment pressure measuring device|AbViser AutoValve IAP Monitoring Device will be used on all patient enrolled in the research study.
16107486|NCT02107768|Other|Aerobic exercise|"Other: Aerobic exercise The intervention group will conduct a 12 week training period with two training sessions of 60 minutes per week at a local hospital. The start shall be made within 6 weeks after stroke . The training shall be conducted in a group with a maximum of 10 participants and start running as new participants in the intervention group will be added.The intensity during the exercise program should be individualized and based on the initial tests . Patients should be advised to reach a degree of exertion 13-15/20,Rate of Perceived Exertion (Borg 's RPE scale) .
~Two fitness goals was to be achieved during the training session
~1. An individual training level corresponded to 50% or more of maximal oxygen uptake for at least 40 min ( Borg 9-11/20 ) . Which corresponds to 70 % of maximum heart rate.
~2:nd 80% or more of the estimated maximum oxygen uptake during two periods of 8 minutes( Borg 13-15/20 ) . Which corresponds to 85 % of maximum heart rate."
16107487|NCT02107755|Biological|ipilimumab|Given IV
16107488|NCT02107755|Radiation|stereotactic radiosurgery|Undergo stereotactic radiosurgery
16107489|NCT02107755|Other|laboratory biomarker analysis|Blood and tissue samples will be collected for research purposes.
16107490|NCT02107742|Procedure|Normal speed lidocaine injection|30 seconds
16107491|NCT02107742|Procedure|Slow lidocaine injection|speed 45 seconds
16107492|NCT02107742|Procedure|Fast lidocaine injection|speed 15 seconds
16107493|NCT02107729|Procedure|Large needle gauge lidocaine injection|21 G
16107494|NCT02107729|Procedure|Normal needle gauge lidocaine injection|23 G
16107495|NCT02107729|Procedure|Small needle gauge lidocaine injection|27 G
16107496|NCT02107716|Procedure|Lidocaine injection with bicarbonate|bicarbonate added to change pH
16107497|NCT02107716|Procedure|lidocaine injection|Lidocaine injection with pH unchanged
16107498|NCT02107703|Drug|Abemaciclib|Administered Orally
16107499|NCT02107703|Drug|Fulvestrant|Administered IM
16107500|NCT02107703|Drug|Placebo|Administered Orally
16107501|NCT02107690|Procedure|Low temperature lidocaine injection|4 °C
16107502|NCT02107690|Procedure|Room temperature lidocaine injection|20 °C
16107503|NCT02107690|Procedure|Body temperature lidocaine injection|37 °C
16107504|NCT02107664|Radiation|Palliative RT for bone cancer pain|
16107505|NCT02107638|Procedure|OMM treatment arm|"OMM is a gentle hand-on manual therapy. The research team created a protocol coined PARK-OMM protocol. These techniques aim to help treat myofascial restrictions and improve joint range of motion."
16107506|NCT02107638|Other|Counseling|Patients will be counseled on Parkinson's Disease related issues including prevention of falls, medications, diet, nutrition, exercise, tai-chi, yoga, meditation, and mental health.
16107507|NCT02107625|Behavioral|Diet A i.e. Low FODMAP diet|
16107508|NCT02107625|Behavioral|Diet B, i.e. Traditional IBS diet|
16107509|NCT02107612|Device|Integrated system to insert two splinted (bar) mini dental implants for mandibular overdenture|
16107510|NCT02107612|Other|Denture|
16107511|NCT02107599|Drug|Florbetapir (18F)|No Florbetapir (18F) will be administered in this study.
16107512|NCT02107586|Procedure|Biceps tenotomy|A biceps tenotomy procedure involves cutting of the long head of the biceps just prior to its insertion on the superior labrum of the glenoid.
16107513|NCT02107586|Procedure|Biceps tenodesis|Biceps tenodesis involves detaching the long head of the biceps from it's superior labrum in the shoulder and reattaching it to the humerus bone just below the shoulder.
16107514|NCT02107573|Procedure|Rotator Cuff Repair without Suprascapular Nerve decompression|Traditional rotator cuff repair without Suprascapular nerve decompression
16107515|NCT02107573|Procedure|Rotator Cuff Repair with Suprascapular Nerve decompression|Traditional rotator cuff repair with Suprascapular nerve decompression
16107516|NCT02107547|Procedure|Biceps tenodesis|A biceps tenodesis involves cutting the tendon within the shoulder joint and reattached further down the arm.
16107517|NCT02107547|Procedure|Labral repair|Repair of a Superior Labrum Anterior and Posterior lesion involves placing small anchors in the glenoid to re-attach the torn labrum.
16107518|NCT02107534|Behavioral|parent training (dyslexia)|The intervention program is designed for group sizes of three to ten persons. A cognitive behavioral approach was chosen.
16107519|NCT02107521|Other|Intracytoplasmic morphologically selected sperm injection|Sperm selection for injection will be performed at 6600x magnification
16107520|NCT02107521|Other|Intracytoplasmic sperm injection|sperm selection for injection will be performed under 400x magnification
16107521|NCT02107495|Device|Samsung LABGEO IVD-A20 CHF Test|
16107522|NCT02107482|Device|Levia Narrow Band UVB|The device's spectral output is is Narrow Band UVB (NB-UVB) (NB-Levia): 308-312 nm
16107523|NCT02107482|Device|Levia sham/visible-light source|the light spectrum is in the range of 400-700nm, the light is produced using the same Levia® device. Levia® enable the user to switch off the UVB light and only produce visible light spectrum.
16107524|NCT02107469|Drug|Sida cordifolia roots|Sida cordifolia roots, crude drug (coarse powder) a plant product 7g (packages prepared) are soaked in 112ml water (measurement cup provided) for 12 hours and then boiled until the level is reduced to 1/4 of hight. Fluid is filtered an drunk after cooling down to room temperature - orally 2 times a day before breakfast and dinner
16107525|NCT02107469|Drug|Phyllanthus niruri|Phyllanthus niruri (whole plant) fine powder 3g three times a day with warm water before meals taken orally.
16107526|NCT02107469|Drug|Sida cordifolia roots extract|gelatine capsule with 300mg Sida cordifolia roots spraydry extract 12:1 concentrated normalized to alkaloids (alcoholic/aqueous extract) - 2 capsules taken orally 2 times a day with warm water before meal
16107527|NCT02107469|Drug|Phyllanthus niruri extract|gelatine capsule with 300mg Phyllanthus niruri spray dry extract 5:1 concentrated normalized to bitters (alcohol/aqueous extract) - 2 capsules taken orally 3 times a day with warm water before meal
16107528|NCT02107469|Other|Sida cordifolia placebo|300mg inert Maltodextrin in gelatine capsule. 2 capsules given 2 times a day orally with warm water before meals
16107863|NCT02105012|Drug|BD MDI 320 µg|Budesonide Inhalation Aerosol administered as 2 inhalations BID
16107529|NCT02107469|Other|Phyllanthus niruri placebo|300mg inert Maltodextrin in gelatine capsule. 2 capsules given 3 times a day orally with warm water before meals
16107530|NCT02107456|Device|Dry Needling|Dry needling was performed for one week, three times a week.
16107531|NCT02107443|Behavioral|Geriatric Assessment Summary|Complete summary of results from the Geriatric Assessment
16107532|NCT02107443|Behavioral|Geriatric Assessment Targeted Recommendations|"Recommendations are made based on areas patients were impaired in on the Geriatric Assessment. They include referrals, tests, medication review, instructions, and support services. The choice of which recommendation to implement is left to the discretion of the physician.
~Treatment modifications"
16107533|NCT02107443|Behavioral|Geriatric Assessment (GA)|A GA measures the issues important to older patients, including function, psychological status, cognitive abilities, social support, and the impact of medical problems on quality of life.
16107534|NCT02107430|Biological|Dendritic Cells DCVAC/PCa|DCVAC/PCa arm post radiotherapy
16107535|NCT02107430|Radiation|Standard radiotherapy|radiotherapy
16107536|NCT02107417|Device|active TENS|Experimental Group (EG) who will receive the application of active TENS. The participants of these group will receive TENS within the following parameters: VF mode TENS with a variable frequency between 7 Hz and 65 Hz. It has a pulse width of 200 µs, this is the highest tolerable intensity while still remaining comfortable for the patient. It has an application time of 60 minutes with the highest tolerable intensity, while still remaining comfortable for the patient.
16107537|NCT02107417|Device|placebo TENS|who will be administering the placebo TENS.The participants of these group will receive TENS within the following parameters: VF mode TENS with a variable frequency between 7 Hz and 65 Hz. It has a pulse width of 200 µs, this is the highest tolerable intensity while still remaining comfortable for the patient. It has an application time of 60 minutes The TENS-placebo will be applied where no current will be emitted. Patients in the placebo group will only feel the tingling for 45 seconds and after this period the device will not emit impulses, but it will work for 1 hour.
16107538|NCT02107404|Biological|Dendritic Cells DCVAC/PCa|DCVAC/PCa Experimental therapy
16107539|NCT02107391|Biological|Dendritic Cells DCVAC/PCa|Combination therapy with DCVAC/PCA add on to and Standard of Care Hormone Therapy
16107540|NCT02107391|Drug|Leuprolide acetate|Standard of Care Hormone Therapy as an Active Comparator
16107541|NCT02107391|Drug|Goserelin Acetate|Standard of Care Hormone Therapy as an Active Comparator
16107542|NCT02107378|Biological|DCVAC/OvCa|DCVAC/OvCa is the experimental therapy added on to Paclitaxel or topotecan or doxorubicin
16107543|NCT02107378|Drug|Standard of Care (Paclitaxel or topotecan or doxorubicin)|Paclitaxel or topotecan or doxorubicin is Standard of Care First Line Chemotherapy
16107544|NCT02107365|Drug|Asunaprevir|Asunaprevir 100 mg, 1 capsule twice a day from Day 0 to Week 24
16107545|NCT02107365|Drug|Daclatasvir|Daclatasvir 60 mg, 1 tablet once a day from Day 0 to Week 24
16107546|NCT02107365|Drug|Ribavirin|Ribavirin tablets or capsules 200 mg, weight-based daily dose ( <75 kg : 1000 mg ; ≥ 75 kg : 1200 mg), from Day 0 to Week 24
16107547|NCT02107365|Drug|Pegylated Interferon alpha-2a|Pegylated Interferon alpha-2a, by subcutaneous injection 180µg / week, from Day 0 to Week 24
16107548|NCT02107339|Drug|Methadone|Methadone 0.2 mg/kg administered at induction of anesthesia
16107549|NCT02107339|Drug|Hydromorphone|Hydromorphone 2 mg administered at the conclusion of anesthesia
16107550|NCT02107326|Device|Webdia Software|
16107551|NCT02107313|Drug|Fed Cohort PBT2|PBT2 250 mg is administered orally following a period of fasting for 10 hours and a high fat breakfast.
16107552|NCT02107313|Drug|Fasted Cohort PBT2|PBT2 250 mg is administered orally after a period of fasting of 10 hours and without food
16107553|NCT02107300|Drug|NeutraSal|NeutraSal is a powder that when dissolved in water creates a supersaturated calcium phosphate rinse.
16107554|NCT02107300|Drug|Placebo Comparator|Placebo is a powder consisting of sodium chloride only; chosen to mimic NeutraSal
16107555|NCT02107287|Radiation|IMRT Technique|
16107556|NCT02107274|Drug|Azithromycin|Azithromycin (C38H72N2O12 MW 749) is a 15-membered azalide, a subclass of macrolide antibiotics
16107557|NCT02107274|Drug|Placebo for Azithromycin|In Part One of the study participants will be randomised to receive 12 weeks of either placebo or azithromycin in a 1:1 ratio in a double-blinded fashion. After 12 weeks, in Part Two of the study, all participants will receive placebo in a double-blinded fashion for an additional 12 weeks.
16107558|NCT02107261|Drug|incobotulinumtoxin A|Incobotulinumtoxin A is being used on average doses between 10U and 30 Units per subject, but at no time will any subject receive over 100 Units. Each study visit, the assessing physician will select the muscles and the amounts of medication to be injected.
16107559|NCT02107248|Behavioral|Sleep position: no restrictions|during the first eight weeks after total hip replacement following a posterolateral surgical approach
16107560|NCT02107248|Behavioral|Sleep position: supine|during the first eight weeks after total hip replacement following a posterolateral surgical approach
16107561|NCT02107235|Drug|oral rigosertib|
16107562|NCT02107235|Drug|cisplatin|
16107563|NCT02107235|Radiation|Radiotherapy|
16107564|NCT02107222|Device|CO2-Removal (PALP-Device/MaquetCP)|extracorporeal circuit to remove CO2 out of the blood
16107565|NCT02107209|Procedure|Bronchoscopic Lung volume reduction|Fiberoptic bronchoscopy is used to inject the biological agents into the targeted lung segment
16107566|NCT02107196|Drug|Ibodutant 10 mg|Oral tablet, to be given once daily.
16107567|NCT02107196|Drug|Placebo|Oral tablet, (identical in appearance and weight to ibodutant tablets), to be given once daily.
16107568|NCT02107183|Device|Optiflow (Fisher & Paykel Healthcare)|This device delivers high-flow oxygen through nasal cannula
16107569|NCT02107183|Device|Venturi mask|This device delivers low-flow oxygen at predetermined concentrations
16107570|NCT02107170|Drug|Sevoflurane|sevoflurane-based general anesthesia
16107571|NCT02107170|Drug|Propofol|total intravenous anesthesia
16107572|NCT02107170|Drug|Remifentanil|
16107573|NCT02107157|Device|755nm Laser with Cap Array|
16107574|NCT02107144|Drug|trimetazidine|After being randomized to Trimetazidin and cardiac medication vs. only cardiac medication, patient will undergo scheduled PCI of single, new, native coronary artery lesion using balloon predilatation and subsequent stenting.
16107576|NCT02107118|Biological|ARM 1: AdMSC: adipose stem cells|Adipose tissue will be harvested from all patients as previously described and stem cells will be cultured. Cells are returned to the study doctor for installation into the subject every 2 weeks for 3 months.
16107577|NCT02107118|Other|ARM 2: Placebo|Adipose tissue will be harvested from all patients as previously described and stem cells will be cultured. For those subjects in the placebo arm, the stem cells will be frozen for later use after one year when the patients cross over into the treatment arm.
16107578|NCT02107105|Other|Quality-of-Life Assessment|Complete quality of life questionnaire
16107579|NCT02107105|Other|Questionnaire Administration|Complete quality of life questionnaire
16107580|NCT02107092|Drug|Sodium Zirconium Cyclosilicate|Oral 10g once daily with breakfast for 11 months.
16107581|NCT02107079|Drug|Melatonin|swallowing 1 piece, collecting saliva afterwards
16107582|NCT02107066|Behavioral|Exercise|Weekly telephone counseling to increase aerobic exercise to 150 min/wk for 6 months.
16107583|NCT02107053|Dietary Supplement|PJ|
16107584|NCT02107053|Drug|IV iron|IV iron is routinely administered to dialysis patients worldwide to correct anemia
16107585|NCT02107027|Device|nMARQ catheter|"In this arm the circular ablation catheter will be used for a quick mapping of left atrium with Carto system. The catheter will be positioned to pulmonary veins ostium to deliver radiofrequency on 1 to 10 electrodes simultaneous. The same catheter will be used to document pulmonary veins isolation (PVI).
~A waiting period of 30 minutes will be observed after PVI to document possible reconnection(s). Adenosine will be injected (except in case of adenosine contraindication) and reconnection(s) site(s) will be noted."
16107586|NCT02107027|Device|Navistar catheter|"In this arm the conventional catheter will be used. It will be used for a left atrium quick mapping on Carto system. Radiofrequency will be delivered in a sequential manner in pulmonary veins for point by point ablation. Isolation will be guided and confirmed with the Lasso decapolar diagnostic catheter (Biosense Webster, Diamond Bar, USA).
~A waiting period of 30 minutes will be observed after PVI to document possible reconnection(s). Adenosine will be injected (except in case of adenosine contraindication) and reconnection(s) sites will be noted."
16107587|NCT02107014|Drug|Low Dose Naltrexone|Naltrexone 4.5 mg p.o. nocte
16107588|NCT02107001|Procedure|Lung ultrasound|Lung ultrasonography performed and interpreted by a physician (Pulmonologist or Emergency Physician) possessing specific knowledge in the procedure and a training of at least 100 thoracic ultrasonographies in accordance to a prespecified protocol.
16107589|NCT02106988|Radiation|Radiation Therapy|Radiation therapy delivered for a total dose of 50.4 to 54 Gy 5 days a week for 28 to 30 treatments.
16107590|NCT02106988|Drug|Dexamethasone|40 mg by vein Days 1-3 in a 21 day cycle.
16107591|NCT02106988|Drug|Etoposide phosphate|67 mg/m2 by vein on Days 1-3 of a 21 day cycle.
16107592|NCT02106988|Drug|Ifosfamide|1 g/m2 by vein on Days 1-3 of a 21 day cycle.
16107593|NCT02106988|Drug|Mesna|0.4 g/m2 by vein on Days 1-3 with Ifosfamide, 0.6 g/m2 by vein over 24 hours daily on Days 1-3 via ambulatory pump.
16107594|NCT02106988|Drug|Carboplatin|200 mg/m2 by vein on Day 1 of a 21 day cycle.
16107595|NCT02106975|Drug|Ascorbic Acid|Intervention
16107596|NCT02106975|Drug|Placebo: 5% Dextrose in water|Placebo
16107597|NCT02106962|Drug|Topical Tranexamic Acid 5% with bacitracin|Selected participants received a fixed amount of tranexamic acid 5 %and bacitracin applied with compression up to 3 times (13 minutes total) per hemodialysis fistula needle site.
16107598|NCT02106962|Other|Topical Tranexamic Acid 25% with bacitracin|Selected participants received a fixed amount of tranexamic acid 25%and bacitracin applied with compression up to 3 times (13 minutes total) per hemodialysis fistula needle site.
16107599|NCT02106949|Device|SMS contact with patient after discharge in intervention group|
16107600|NCT02106923|Drug|1 tablet Empagliflozin/2 tablets Metformin XR|Active Comparator: 1 x Empagliflozin/2x Metformin XR tablets
16107601|NCT02106923|Drug|10 mg Empagliflozin/1000 mg Metformin XR|Experimental: high dose Empagliflozin/Metformin XR, FDC tablet
16107602|NCT02106923|Drug|1 tablet 10 mg Empagliflozin/3 tablets Metformin XR|Active Comparator: 1 x Empagliflozin/3 x Metformin XR tablets
16107603|NCT02106923|Drug|2 tablets 5 mg Empagliflozin/750 Metformin XR|Experimental:2 x low dose Empagliflozin/Metformin XR FDC tablets
16107604|NCT02106923|Drug|1 tablet Empagliflozin/2 tablets Metformin XR|Active Comparator: 1 x Empagliflozin/2x Metformin XR tablets
16107605|NCT02106923|Drug|10 mg Empagliflozin/1000 mg Metformin XR|Experimental: high dose Empagliflozin/Metformin XR, FDC tablet
16107606|NCT02106910|Device|Cytosponge|The Cytosponge is a simple, non-endoscopic device developed for endoscopic screening of subjects at risk for Barrett's esophagus (BE) by investigators at the University of Cambridge in the U.K. The Cytosponge is an ingestible gelatin capsule enclosing a compressed spherical polyurethane mesh sponge of 3 cm diameter, the center of which is attached to a string (Astralen, braided synthetic non-absorbable suture) (Figure 1). The capsule and string are swallowed with water. The string is held at the mouth without tension by means of a 7 cm cardboard tab attached to the string, and esophageal peristalsis and gravity move the capsule into the stomach. After 5 to 7 minutes (during which the gelatin capsule dissolves and the sponge is liberated), the sponge is withdrawn by gentle traction on the string and as it does so, collects cells from the lining of the esophagus. The sponge is placed in fixative for 48 hours, then the cells are pelleted, and processed into paraffin blocks
16107607|NCT02106897|Drug|BIIB059|See Arm Descriptions
16107608|NCT02106897|Drug|Placebo|See Arm Descriptions
16107609|NCT02106884|Drug|Nab-paclitaxel|
16107610|NCT02106884|Drug|Gemcitabine|
16107611|NCT02106871|Drug|Sildenafil|50mg of Sildenafil daily for 4 weeks
16107612|NCT02106858|Drug|Regorafenib (Stivarga,BAY73-4506)|Patients treated by Physician with Stivarga under approved local prescriptions
16107613|NCT02106845|Drug|Digoxin|Single dose of digoxin 0.5 mg (2 tablets 0.25 mg) orally without and with regorafenib
16107614|NCT02106845|Drug|Rosuvastatin|Single dose of rosuvastatin 5mg (1 tablet 5 mg) without and with regorafenib 160 mg q.d. (4 tablets 40 mg)
16107615|NCT02106845|Drug|Regorafenib (Stivarga, BAY73-4506)|Once daily orally 160 mg (4 tablets 40 mg)
16107616|NCT02106832|Drug|Ciprofloxacin (BAYQ3939) dry powder for inhalation|Ciprofloxacin dry powder for inhalation (DPI) 32.5 mg inhaled twice daily in cycles of 28 days on-treatment and 28 days off-treatment.
16108075|NCT02103309|Device|Nelfilcon A contact lenses|
16107617|NCT02106832|Drug|Ciprofloxacin (BAYQ3939) dry powder for inhalation|Ciprofloxacin DPI 32.5 mg inhaled twice daily in cycles of 14 days on-treatment and 14 days off-treatment.
16107618|NCT02106832|Drug|Placebo|Matching placebo inhaled twice daily intermittently for 28 days on / 28 days off
16107619|NCT02106832|Drug|Placebo|Matching placebo inhaled twice daily intermittently for 14 days on / 14 days off
16107620|NCT02106819|Behavioral|Testing of emotional communication ability|Assessment of comprehension and expression of emotional facial and prosodic expressions and assessment of emotional reactivity via ratings of emotionally evocative pictures and words.
16107621|NCT02106819|Procedure|magnetic resonance imaging (MRI) of the brain|Cerebellar participants who score at least 1 and a 1/2 standard deviations below the mean on the Florida Affect Battery and who have no contra-indications to scanning will be given an MRI. Healthy control participants who are willing and able to be scanned will also be given an MRI of the brain to use for analysis comparison.
16107622|NCT02106806|Dietary Supplement|Zinc|35 mg of elemental zinc twice daily for 16 weeks
16107623|NCT02106806|Other|Placebo|One capsule, twice daily for 16 weeks
16107624|NCT02106793|Drug|Mitomicin C|Mitomicin C (0.4 mg/ml) will be provided in a sterile vial and prepared by pharmacist at the Faculty of Medicine Ramathibodi Hospital.The treatment solution will be drawn and soaked ono two one inch neurosurgical cotton pledgets. Each pledget will be placed on each side of the nose for 5 minutes. The nurse will set the alarm for removal of the cotton pledgets, then normal saline will be used to irrigate both sides of the nose, using 100 ml on each side.
16107625|NCT02106793|Drug|Identical placebo solution|Identical placebo solution
16107626|NCT02106780|Drug|14C-labeled ASP1707|oral
16107627|NCT02106767|Drug|Rosuvastatin|Rosuvastatin 20mg po x1
16107628|NCT02106767|Drug|Rosuvastatin plus rifampin|Rifampin 600mg IV infused over 30 minutes followed by rosuvastatin 20mg PO x1
16107629|NCT02106754|Behavioral|Brief Intervention|
16107630|NCT02106754|Behavioral|Brief Intervention with Coaching|
16107631|NCT02106754|Behavioral|Treatment as Usual|
16107632|NCT02106741|Behavioral|Relaxation acupressure|"The relaxation acupressure protocol will use a set of nine fixed acupoints: forehead, twixt the eyebrows (unilateral); posterior neck, behind the ears (bilateral); palmer side of hand at wrist (bilateral); inside of lower leg (bilateral); top of foot (bilateral).
~A trained acupressure educator will meet with each participant and demonstrate the sites and techniques for self-administered acupressure. Additionally, each participant will receive a demonstration DVD and a laminated handout detailing the locations of each acupoint.
~Participants will be asked to perform daily acupressure sessions using the assigned sites. Each site is stimulated for 3 minutes, and the entire session can be completed in approximately 30 minutes."
16107633|NCT02106741|Behavioral|Stimulating acupressure|"The stimulating acupressure protocol will use a set of ten fixed acupoints: top of the head (unilateral); below the navel (unilateral); back of the hand (bilateral); outside of lower leg (bilateral); inside of lower leg (bilateral); inside of ankle (bilateral).
~A trained acupressure educator will meet with each participant and demonstrate the sites and techniques for self-administered acupressure. Additionally, each participant will receive a demonstration DVD and a laminated handout detailing the locations of each acupoint.
~Participants will be asked to perform daily acupressure sessions using the assigned sites. Each site is stimulated for 3 minutes, and the entire session can be completed in approximately 30 minutes."
16107634|NCT02106728|Behavioral|Multi-Family Therapy|Multi-Family Therapy is conducted once per week over the course of 8 weeks for 1.5 hours per session. Therapy is provided to a minimum of 3 families and a maximum of 6 families with the aid of two to three therapist group leaders. Group topics are set and cover material on eating disorder psychoeducation, care-giving styles, meal support, and relapse prevention.
16107635|NCT02106728|Behavioral|Supportive Family Therapy|Supportive Family Therapy is treatment as usual in the eating disorders program at TGH. Families meet independently with a therapist once per week for 1 hour per session. The length of the therapy and the topics of therapy are decided upon collaboratively with the therapist and the family.
16107636|NCT02106715|Other|Training|Two exercises for training of core stability and mobility.
16107637|NCT02106702|Behavioral|Navigator enhanced case-management|Patient navigators are non-clinical, paraprofessional peers who are HIV-infected and have lifetime histories of detention and substance abuse. Working with the patient, they facilitate adherence to a comprehensive care plan designed to address clients' multiple risks and needs. Patients have access to Navigator services for one year after study enrollment.
16107638|NCT02106702|Behavioral|Forensic AIDS Project|The Forensics AIDS Project provides primary care to HIV-infected detainees, as well as up to 90 post-release case-management services which include discharge planning.
16107639|NCT02106689|Device|Needle free system|Approximately 60 patients will be randomized in a 1:1 ratio to either receive their gonadotropin injections using the Comfort-in™ needle free system (treatment group), or through the standard needle and syringe (control group).
16107640|NCT02106689|Device|Standard needle injection system|Approximately 60 patients will be randomized in a 1:1 ratio to either receive their gonadotropin injections using the Comfort-in™ needle free system (treatment group), or through the standard needle and syringe (control group).
16107641|NCT02106663|Procedure|Circumferential Pulmonary Vein Ablation|Contiguous ablation lesions will be performed to encircle the two left and right pulmonary veins (PVs) of the left atrium, guided by 3D electroanatomic mapping. After completion of the circumferential ablation, PV isolation will be confirmed by the mapping catheter, and further focal ablation performed as required until electrical PV isolation is confirmed.
16107642|NCT02106663|Procedure|Segmental Pulmonary Vein Isolation|Electrical potentials recorded in the pulmonary vein (PV) ostium using a circular mapping catheter, representing electrical connections between the left atrium and PVs will be ablated at or just proximal to the PV ostium in the PV antrum. Ablation will be performed segmentally at multiple sites guided by the mapping catheter until mapping demonstrates elimination of all PV potentials.
16107643|NCT02106650|Drug|Folotyn and Leucovorin|
16107644|NCT02106650|Drug|Folic Acid|Folic acid (1.0 mg PO QD) is to be initiated at least 10 days prior to Folotyn administration, or per the USPI for Folotyn.
16107689|NCT02106338|Other|Placebo|Placebo capsules have the same inert components as CRS3123; 2 subjects randomized in each cohorts recieve 200mg, 400mg; and 600mg, or 100mg are planned respectively given orally every 12 hours for 10 days
16108076|NCT02103309|Device|Etafilcon A contact lenses|
16107645|NCT02106650|Drug|Vitamin B12|Vitamin B12 (1 mg IM) is to be administered within 10 weeks prior to initiation of Folotyn and can be administered during Screening. Subsequent vitamin B12 injections may be given the same day as treatment with Folotyn and patients are to receive vitamin B12 every 8 to 10 weeks while treated with Folotyn.
16107646|NCT02106637|Drug|Varenicline|drug will be initiated during hospitalization and continued for 12 weeks following discharge
16107647|NCT02106637|Drug|placebo|placebo
16107648|NCT02106624|Other|nitrogen supply|Nitrogen supply could be administered through amino acid in parenteral nutrition, proteins in enteral nutrition.
16107649|NCT02106611|Other|Clinical Assessment|HL treatment will be determined by review of available medical records as archived at MSKCC. Recorded variables will include: (1) RT - field, fractional and cumulative dose, and duration; (2) chemotherapy - regimen, planned interval, dose per cycle, and cumulative dosages. Patients will also be asked to complete the FACT-LYM questionnaire and the FACIT Fatigue questionnaire.
16107650|NCT02106611|Procedure|Stress cardiac MRI|Both imaging tests will be performed within a 30 day interval, with the two modalities interpreted by dedicated study investigators blinded to the results of the other modality.
16107651|NCT02106611|Procedure|Stress echocardiogram|Both imaging tests will be performed within a 30 day interval, with the two modalities interpreted by dedicated study investigators blinded to the results of the other modality.
16107652|NCT02106598|Drug|fluorescent cRGDY-PEG-Cy5.5-C dots|
16107653|NCT02106585|Drug|JTT-251 or Placebo|Subjects will receive JTT-251 or Placebo
16107654|NCT02106572|Drug|abnobaVISCUM 900|intravesical instillation of abnobaVISCUM 900 13 times during treatment period
16107655|NCT02106572|Drug|Mitomycin C|intravesical instillation of Mitomycin C 10 times during treatment period
16107656|NCT02106559|Drug|porfimer sodium|Given IV
16107657|NCT02106559|Procedure|therapeutic conventional surgery|Undergo tumor resection and/or radical pleurectomy
16107658|NCT02106559|Drug|photodynamic therapy|Undergo PDT
16107659|NCT02106546|Drug|Carboplatin|Carboplatin administered intravenously over approximately 15 to 30 minutes at (AUC 6 mg/mL/min) immediately following paclitaxel infusion.
16107660|NCT02106546|Drug|Veliparib|Capsules taken orally twice a day, 12 hours apart.
16107661|NCT02106546|Drug|Paclitaxel|Paclitaxel administered intravenously over 3 hours at a dose of 200 mg/m².
16107662|NCT02106546|Drug|Placebo to veliparib|Capsules taken orally twice a day, 12 hours apart.
16107663|NCT02106533|Other|Aerobic exercise training|The exercise training program was comprised of three 60-minute exercise sessions per week over a 3-month period. Each exercise session consisted of a 5 minute warm up, 30-50 minutes of aerobic exercise performed on a treadmill and 5 minutes of cool-down exercises. Aerobic exercise intensity was set at the corresponding heart rate between the VAT and RCP. All patients were able to achieve the set aerobic training intensity.
16107664|NCT02106520|Drug|Bevacizumab|
16107665|NCT02106520|Drug|placebo|
16107666|NCT02106507|Drug|apalutamide|apalutamide, 240 mg/day, oral
16107667|NCT02106507|Drug|Everolimus|5 mg/day of everolimus dose of everolimus will be escalated to 10 mg/day depending on the safety seen during dose escalation and steady-state trough drug levels as recommended
16107668|NCT02106494|Drug|APF530|
16107669|NCT02106494|Drug|Ondansetron|
16107670|NCT02106494|Drug|Ondansetron placebo|
16107671|NCT02106494|Drug|APF530 placebo|
16107672|NCT02106494|Drug|Fosaprepitant|
16107673|NCT02106494|Drug|Dexamethasone|
16107674|NCT02106481|Drug|Femoral Nerve Catheters|"Catheter will be bolused with 0.5 % ropivacaine around the femoral nerve and occlusive dressing applied over the catheter.
~Patients with CFNB will receive ropivacaine 0.2% infusion (the infusion rate will be dependent on the clinical judgement of the anaesthesiologist)"
16107675|NCT02106481|Drug|Single Shot Femoral Nerve Blocks|The group with SSFNB will receive a femoral nerve block before the surgery in the pre-operative area guided by a nerve stimulator and ultrasound. A bolus of 0.5 % ropivacaine will be injected around the femoral nerve.
16107676|NCT02106468|Drug|Prednisone tablet 5mg|This group included 15 patients who received prednisone (Delta-cortene Fort®, Lepetit, Carmano, Melano, Italy) at 40mg /day (8 tablets/day in divided dose , 4 tablet at morning and 4 at evening) for 6 weeks then 20mg/day for 2 week then to 10 mg/day for 2 week, and finally to 5 mg /day for the last 2 weeks.
16107677|NCT02106468|Drug|Omega-3 soft capsules 1000 mg|This group included 15 patients who received Omega-3 soft gelatin capsules 1000 mg (Super Omega; Technopharma, Cairo, Egypt). The patients received instruction to take one capsule three times daily for 3 months.
16107678|NCT02106455|Drug|Sodium risedronate|Sodium risedronate tablets
16107679|NCT02106442|Drug|Sodium risedronate|Sodium risedronate tablets
16107680|NCT02106416|Procedure|PET/MRI|Simultaneous PET/MRI (3T system)
16107681|NCT02106403|Other|Prototype disinfectant spray formulation|0.13% w/w BAC and 1% MGA. After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound
16107682|NCT02106403|Other|Reference product|0.13% w/w BAC. After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound
16107683|NCT02106403|Other|Negative control|0.9% w/v sodium chloride solution. After wounding, the product will be held approximately 10 cm above the wounding area, and sprayed twice towards the wound
16107684|NCT02106390|Biological|Meningococcal group B Vaccine, rMenB+OMV NZ|4 doses administered intramuscularly on Days 1, 61, 121 and 301 with blood draw visits at Days 1, 151, 301 and 331 and who will receive reminder calls at 2 and 4 days after each vaccination visit and safety calls on Days 201 and 251.
16107685|NCT02106390|Biological|Meningococcal ACWY Conjugate Vaccine, MenACWY|4 doses administered intramuscularly on Days 1, 61, 121 and 301 with blood draw visits at Days 1, 151, 301 and 331 and who will receive reminder calls at 2 and 4 days after each vaccination visit and safety calls on Days 201 and 251.
16107686|NCT02106364|Drug|Insulin Peglispro|Administered SQ
16107687|NCT02106364|Drug|Insulin Glargine|Administered SQ
16107688|NCT02106351|Biological|Botulinum toxin type A|Subjects randomised to receive Dysport 2 U/kg, 8 U/kg or 16 U/kg administered intramuscularly in the study limb.
16107729|NCT02106065|Other|Supplemental Education Materials|Participants randomized to the Usual Care (UC) group will receive supplemental educational materials related to aging and dementia.
16107690|NCT02106338|Drug|CRS3123|CRS3123, a methionyl-tRNA synthetase inhibitor, formulated in 100 and 200 mg capsules; 8 subjects randomized in Cohorts A through C receive doses of 200 mg, 400 mg; and 600 mg or 100mg are planned respectively given orally every 12 hours for 10 days.
16107691|NCT02106325|Drug|Ketamine|IV of Ketamine (.25mg/kg)
16107692|NCT02106325|Drug|Diphenhydramine|Intravenous Diphenhydramine (25mg) at the time of presentation to Emergency Department
16107693|NCT02106312|Radiation|dose reduction of preoperative radiotherapy in MLS|A: The primary sarcoma in case of non-metastatic disease for management is with curative intent (regime to be chosen=18 x 2 Gy) B: In case of oligometastatic patients, the metastasis may also be irradiated to a dose of 36 Gy in order to postpone the time interval to next systemic chemotherapy. These patients are usually not operated upon and the total dose may also be reached in 12 times 3 Gy, for convenience purposes.
16107694|NCT02106299|Device|Regen sling|Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a Regen sling (medprin).
16107695|NCT02106299|Device|tension-free vaginal tape-obturator(TVT-O)|Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator sling TVT-O™ (gynecare™, USA).
16107696|NCT02106286|Drug|Bisoprolol|
16107697|NCT02106273|Device|Bronchial blocker (Coopdech, Arndt)|Using bronchial blocker with LMA
16107698|NCT02106273|Device|LMA-ProsealTM|
16107699|NCT02106260|Drug|CLS003|
16107700|NCT02106247|Drug|BI 1181181 high dose|two tablet
16107701|NCT02106247|Drug|BI 1181181 low dose|one tablet
16107702|NCT02106247|Drug|Placebo|tablet
16107703|NCT02106234|Other|No prophylactic iv hydration|Control group: Patients having been referred for an elective procedure involving intravascular iodinated contrast material administration and for intravenous prophylactic hydration according to current guidelines (but only those patients with an eGFR ≥30ml/min/1.73m2) will NOT receive the standard intravenous prophylactic hydration treatment with normal saline prescribed.
16107704|NCT02106221|Other|Intervention|Will receive payments based on achievement in meeting goals based on specified high value elements as well as effort.
16107705|NCT02106221|Other|Control|Will receive payments based on achievement in meeting goals.
16107706|NCT02106208|Other|Cheese diet|
16107707|NCT02106208|Other|Butter diet|
16107708|NCT02106208|Other|CHO diet|
16107709|NCT02106208|Other|MUFA diet|
16107710|NCT02106208|Other|PUFA diet|
16107711|NCT02106195|Drug|Belumosudil|
16107712|NCT02106182|Drug|Silodosin|
16107713|NCT02106182|Other|Laboratory tests|"Subject's overall health state will be evaluated by clinical laboratory tests.
~Serum chemistry test: Creatinine, Blood Urea Nitrogen(BUN), Aspartate aminotransferase(AST), Alanine aminotransferase(ALT) Urinalysis: Urine Specific Gravity, Urine pH, Urine Protein, Urine Glucose, Urine Ketone, Urine Bilirubin, Urine Urobilinogen, Urine Nitrite, Urine Occult Blood(OB), Urine Red Blood Cell(RBC), Urine White Blood Cell(WBC) Immunoassay: Prostate Specific Antigen(PSA)"
16107714|NCT02106182|Other|3-days voiding diary|3-day voiding diaries will be distributed on Visits 1, 2 and 3. Subjects will record incidence of nocturia during 3 days on the diaries within 7 days of Visits 2 (baseline), 3 and 4. The average will be used to confirm the change in incidence of nocturia (at baseline, results from within 1 week from screening may be used but will be excluded for subjects needing wash-out period).
16107715|NCT02106182|Other|12 weeks|
16107716|NCT02106169|Behavioral|Therapeutic education group|
16107717|NCT02106156|Drug|Pegylated interferon alfa-2a|Pegylated interferon alfa-2a administered according to corresponding summary of product characteristics (SmPC).
16107718|NCT02106156|Drug|Ribavirin|Ribavirin administered according to corresponding summary of product characteristics (SmPC).
16107719|NCT02106143|Device|RejuvenAir™ Radial Spray Cryotherapy|Metered dose radial spray cryotherapy treatment
16107720|NCT02106130|Drug|Rebamipide|oral administration, 3 times/day
16107721|NCT02106130|Drug|Mosapride citrate|oral administration, 3 times/day
16107722|NCT02106104|Drug|Linagliptin 5 mg QD (N=24)|Linagliptin 5 mg will be taken orally, once daily for 8 weeks
16107723|NCT02106104|Drug|Glimepiride 1 mg QD (N=24)|Glimepiride 1 mg will be taken orally, once daily for 8 weeks
16107724|NCT02106091|Drug|AFM11|Accelerated-titration dose-escalation with 1 patient per dose-level, followed by standard dose-escalation (3 + 3 design), Treatment duration: 4 weeks.
16107725|NCT02106078|Behavioral|Moderated Discussion Board|"All groups will have access to asynchronous, moderated discussion boards. Assignment to discussion board will be stratified by randomization group (Level 1, 2 or 3). Level 1 access to the discussion board will serve as our peer support control condition, although we do expect some modest benefit from this intervention alone (Mead et al., 2010).
~The discussion boards will be moderated by trained clinicians (masters level or higher). Discussion boards will be asynchronous, with all posts screened by the moderator(s) before appearing to the group."
16107726|NCT02106078|Behavioral|Psychoeducation|"Online psychoeducation is only available to those randomized to Levels 2 and 3. The core modules of MoodSwings 2.0 will use videos and improved organization of content based on feedback from previous pilot work. Module topic areas include:
~What is bipolar disorder? - Content about symptoms and diagnosis
~Stress and triggers of illness
~Medication and the biological basis of bipolar disorder
~Depression - Symptoms, early detection and helpful strategies
~Mania and hypomania - Symptoms, early detection and helpful strategies"
16107727|NCT02106078|Behavioral|Interactive Psychosocial Tools|"Online psychosocial tools are only available to those randomized to Level 3. They include structured mood monitoring, medication monitoring, and life charting visual tools. There are also interactive worksheets that encourage awareness of negative thoughts and strategies to challenge them, help participants weight the costs and benefits of different behaviors, problem solving and goal setting, and reinforcing self-affirmation. Participants have the opportunity to build a record of personal triggers of illness and illness profile - including early warning signs, and symptoms typically experienced during an episode of illness, as well as a personal relapse prevention plan."
16107728|NCT02106065|Behavioral|Education and Skill-Building Rehabilitation (ESBR)|ESBR intervention consists of four, 90-minute sessions over a 4-6 week period. These four sessions are supplemented with booster sessions at 3 and 9 months post-intervention. Each group session (10 or fewer participants) is attended either in-clinic or via video telehealth technology within the VAPAHCS.
16107730|NCT02106052|Other|Aerobic exercise|The aerobic exercise condition is a graduated program of supervised aerobic exercise up to one hour per day, three days per week, and lasting 6 months. The structured exercise portion of the sessions will initially last for 15-20 minutes at 40-50% heart rate reserve (HRR) and progressively increase up to 35-40 minutes in duration at 65-75% HRR during the last month of the program. The program will focus on large, dynamic movements of the lower extremities (e.g. leg cycling ergometry). There may be some individual variation in adaptations that dictate the exact characteristics of the program.
16107731|NCT02106052|Other|Stretching and toning exercise|The stretching and toning condition is a supervised stretching program with Therabands up to one hour per day, three days per week, and lasting 6 months. The stretching exercises will be based on a manual published by the National Multiple Sclerosis Society (NMSS) that has been standardized, manualized for reproducibility, and the investigators will progressively include more exercises and sets with Therabands for resistance over the course of the 6-month period.
16107732|NCT02106039|Procedure|intensive monitoring|
16107733|NCT02106026|Other|Preventive education|The intervention group received education to facilitate successful breastfeeding and symptom management as nipple pain. This was supported by strategies designed to (1) prevent problems associated with breastfeeding (nipple lesions, cracks and mastitis), (2) perform breast-care procedures, (3) strengthen information about the advantages of maternal breastfeeding (nutritional support, importance as food for the baby, availability, post-partum recovery) and (4) provide asepsis and hygiene measures.
16107734|NCT02106000|Device|Inhalation profile recorder|Up to three inhalation profiles will be recorded whilst inhaling with maximal effort
16107735|NCT02105987|Drug|ABC/DTG/3TC FDC|Purple, oval, biconvex tablets containing 702 mg Abacavir sulphate which is equivalent to 600 mg ABC, 52.62 mg Dolutegravir sodium which is equivalent to 50 mg Dolutegravir free acid and 300 mg 3TC
16107736|NCT02105987|Drug|Ongoing cART regimen|Stable cART regimens including boosted PI (or ATV unboosted) + 2 NRTIs; NNRTI + 2 NRTIs, or INI (RAL or EVG)+ 2 NRTIs
16107737|NCT02105974|Drug|Fluticasone Furoate/Vilanterol|100 mcg FF micronized drug blended with lactose per blister in one strip and 25 mcg VI micronized drug blended with lactose and magnesium stearate per blister in another strip, administered together by ELLIPTA™ inhaler
16107738|NCT02105974|Drug|Vilanterol|25 mcg of Vilanterol micronized drug (as the 'M' salt triphenylacetate) blended with lactose and magnesium stearate per blister in one strip and lactose in another strip, administered together by ELLIPTA™ inhaler
16107739|NCT02105961|Drug|Mepolizumab|Humanised IgG antibody (IgG1, kappa) with human heavy and light chain frameworks, provided as a lyophilised cake in sterile vial. Vial to be reconstituted with Sterile Water for Injection, just prior to use.
16107740|NCT02105961|Drug|Placebo|Sterile 0.9percent sodium chloride solution
16107741|NCT02105948|Drug|Mepolizumab|Humanised IgG antibody (IgG1, kappa) with human heavy and light chain frameworks, provided as a lyophilised cake in sterile vial. Vial to be reconstituted with Sterile Water for Injection, just prior to use.
16107742|NCT02105948|Drug|Placebo|Sterile 0.9% sodium chloride solution
16107743|NCT02105922|Procedure|Heavy Resistance Training|Supervised Heavy Resistance Training three times weekly for 3 months.
16107744|NCT02105922|Procedure|Light Intensity Training|Home-based Light Intensity Training three-five times weekly for 3 months.
16107745|NCT02105922|Procedure|Protein Whey|Two daily 20g whey protein and 10g carbohydrate supplementations for 3 months.
16107746|NCT02105909|Other|GWAS|
16107747|NCT02105883|Other|Use of identification badge during scenarios|
16107748|NCT02105870|Drug|Abciximab|This drug will be administered intracoronary before percutaneous coronary intervention.
16107749|NCT02105857|Other|grade A+ knee mobilization|grade A+ knee mobilization using the joint active systems knee device, 20minutes twice a day in knee extension and knee flexion
16107750|NCT02105831|Other|Contrast ultrasound skeletal muscle perfusion imaging|1. Contrast ultrasound perfusion imaging will be performed in patients in whom LVAD will be placed for clinical indications of severe heart failure.
16107751|NCT02105805|Behavioral|Dietetic group sessions|Group sessions to improve dietary adherence
16107752|NCT02105792|Drug|second- or third-line glucose-lowering diabetes treatment|Observation of response and disease progression following clinician's addition of a glucose-lowering diabetes therapy (Sulphonylurea, DPP-4 inhibitor, GLP-1R agonist, SGLT2 inhibitor or Glitazone) to existing therapy.
16107753|NCT02105779|Other|Targeted Cognitive Training|At present, the TCT exercises consist of three modules: an Auditory Processing Module (40-50 hours of training); a Visual Processing Module (30 hours); a Cognitive Control Module prototype (20 hours). [Based on the results of our current RCT, Posit Science has revised aspects of the training modules in order to further optimize its effectiveness for treatment of schizophrenia. In this study, we will use updated versions of the training software: an Auditory Module (30 hours), and a Visual Module (30 hours). Features from the Cognitive Control module prototype have been expanded and incorporated into these new modules.
16107754|NCT02105779|Other|Social Cognitive Training|We developed a systematic approach to basic training in facial emotion identification and discrimination and simple social perception and theory of mind tasks using components drawn from three commercially available software packages: the MicroExpressions Training Tool and The Subtle Expressions Training Tool (METT and SETT), plus the MindReading program. Training begins with simple emotion identification tasks, and slowly progressed to more difficult tasks that required subjects to discriminate between two subtle emotion expressions, and to correctly interpret the emotional significance of brief social scenes. A total of 10 hours of training occurred over 8 weeks.
16107755|NCT02105766|Drug|Alemtuzumab|Immunosuppressant
16107756|NCT02105766|Drug|Sirolimus|Immunosuppressant
16107757|NCT02105766|Drug|Cyclophosphamide|Immunosuppressant
16107758|NCT02105766|Drug|Pentostatin|Immunosuppressant
16107759|NCT02105766|Procedure|Radiotherapy|Immunosuppressant and myelosuppressant
16107760|NCT02105753|Device|1210nm Diode Laser treatments|
16107761|NCT02105740|Behavioral|Hypnosis|The hypnosis intervention consists of two 40-minute sessions, with an interval of 7 days between them, emphasizing the pain blocking, the well-being of the patient and the reduction of the symptoms of anxiety and depression of the same.
16107858|NCT02105077|Drug|Anesthesia with inhalative application of xenon gas|
16107859|NCT02105064|Device|Active rTMS|rTMS over supplementary motor area, 1hz, no pauses, 20 minutes/sessions, 5 sessions/week, 4 weeks. Total 20 sessions.
16107762|NCT02105740|Behavioral|Control|The control and experimental groups respond in 3 different moments to Visual Analogue Scale (VAS) for the evaluation of pain, and to Hospital Anxiety and Depression Scale (HADS) to evaluate depression and the anxiety. The first meeting will be made before the hypnosis. In the second meeting, within an interval of 7 days, the scales will be applied in all patients. Before applying the scales, the hypnosis group will be submitted to the session. The third meeting will occur two weeks later, where the scales will be only applied to compare the groups.
16107763|NCT02105727|Behavioral|Community-based salt reduction|
16107764|NCT02105714|Procedure|Stool culturing for pathogenic bacteria|
16107765|NCT02105714|Procedure|Kato-Katz technique|
16107766|NCT02105714|Procedure|Baermann technique|
16107767|NCT02105714|Device|Mini-FLOTAC|
16107768|NCT02105714|Device|Crypto/Giardia Duo Strip|
16107769|NCT02105714|Procedure|Formalin-ether concentration technique|
16107770|NCT02105714|Device|CCA RDT|
16107771|NCT02105714|Procedure|Koga agar plate culture|
16107772|NCT02105714|Procedure|Kinyoun staining|
16107773|NCT02105714|Device|Multiplex PCR|
16107774|NCT02105714|Procedure|Metagenomics analysis|
16107775|NCT02105701|Drug|Grazoprevir + Elbasvir|FDC tablet containing grazoprevir 100 mg and elbasvir 50 mg.
16107776|NCT02105701|Drug|Ribavirin|200 mg capsule
16107777|NCT02105688|Drug|Grazoprevir 100 mg/Elbasvir 50 mg FDC tablet (MK-5172A)|Grazoprevir 100 mg/Elbasvir 50 mg FDC tablet, taken once daily by mouth for 12 weeks.
16107778|NCT02105688|Drug|Placebo to Grazoprevir 100 mg/Elbasvir 50 mg FDC tablet|Placebo Grazoprevir 100 mg/Elbasvir 50 mg FDC tablet, taken once daily by mouth for 12 weeks.
16107779|NCT02105675|Biological|Dendritic Cells DCVAC/PCa|DCVAC/PCa is the experimental therapy added on to Docetaxel
16107780|NCT02105675|Drug|Docetaxel|Docetaxel is Standard of Care First Line Chemotherapy
16107781|NCT02105662|Drug|Grazoprevir 100 mg/Elbasvir 50 mg fixed-dose combination tablets|MK-5172A FDC tablet: MK-5172 (100 mg)/MK-8742 (50 mg)
16107782|NCT02105649|Other|Strengthening exercise + Electrical stimulation of calf muscle|
16107783|NCT02105649|Other|selected physical therapy program|
16107784|NCT02105636|Drug|Nivolumab|
16107785|NCT02105636|Drug|Cetuximab|
16107786|NCT02105636|Drug|Methotrexate|
16107787|NCT02105636|Drug|Docetaxel|
16107788|NCT02105623|Behavioral|Standard Therapy|Risk factor control Diet Exercise for 24months
16107789|NCT02105623|Drug|Rosuvastatin|Risk factor control rosuvastatin 5mg/day for 24months
16107790|NCT02105610|Drug|desflurane, isoflurane, sevoflurane|
16107791|NCT02105610|Drug|total intravenous anesthetics|
16107792|NCT02105597|Other|Mobile application|The intervention in this study is a mobile application which will be downloaded into the participant's smartphone.
16107793|NCT02105584|Device|Implantation of LAA closure device|
16107794|NCT02105571|Behavioral|Intervention|
16107795|NCT02105558|Drug|Epidural anesthesia|"￼An epidural involves injecting pain-blocking medication into a space between the vertebrae and the spinal fluid; it usually takes about 15 minutes to work.
~Epidurals will be placed in a sterile fashion using a 17g Tuohy needle to locate the epidural space via loss-of-resistance to saline at the lumbar vertebral level. 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine will then be used for test dose to exclude intrathecal or intravenous placement of the catheter. Epidural solution composed of 5ml of 0.2% ropivacaine and another 5 ml of 0.2% ropivacaine will then be administered."
16107796|NCT02105558|Drug|Combined spinal and epidural anesthesia|"A spinal is an injection directly into the spinal fluid; it is given in addition to the epidural technique and takes effect in five minutes.
~The epidural space will be located with a 17g Tuohy needle and dural puncture performed with 25g Pencan needle via needle-through-needle technique. Spinal injection of 2ml 0.2% ropivacaine will then be performed and spinal needle removed. An epidural catheter will then be placed and test dose performed with 3 ml of 1.5% lidocaine with 5ug/ml of epinephrine. Maintenance dose will be via an epidural pump using 0.2% ropivacaine at a rate of 12 ml/hr."
16107797|NCT02105545|Other|Cancer Treatment Options|Patients may meet, depending on test results, with their physician and a genetic counselor to discuss possible changes in their treatment options and/or lifestyle changes.
16107798|NCT02105532|Other|Restrictive transfusion policy|Participants allocated to this group will be eligible for transfusion once their Hb level is ≤ 8 g/dL after presentation to hospital. The objective for the attending clinician is to maintain the Hb level between 8.1-10 g/dL for the duration of hospital stay.
16107799|NCT02105532|Other|Liberal Transfusion Policy|Participants allocated to this group will be eligible for transfusion once their Hb level is ≤ 10 g/dL after presentation to hospital. The objective for the attending clinician is to maintain the Hb level between 10.1-12 g/dL for the duration of hospital stay.
16107800|NCT02105519|Biological|Seasonal influenza vaccine (AdimFlu-S)|Participants receiving 0, 1 and 2 dose of AdimFlu-S during the study period.(a) No vaccination: no any influenza vaccination during the study period.(b) One dose of AdimFlu-S group: patient will receive one dose of Seasonal influenza vaccine (AdimFlu-S) at the initiation of the study.(c)Two doses of AdimFlu-S group: patients will receive one dose of Seasonal influenza vaccine (AdimFlu-S) at week 0 and 4 weeks after the initiation of the study.
16107801|NCT02105506|Drug|Tachosil patch|
16107802|NCT02105493|Drug|500 microgram of Nitroglycerin|500 microgram of Nitroglycerin (in 5 mL saline) given intra-arterially through the sheath at the end of transradial procedure
16107803|NCT02105493|Drug|Saline 5 mL|Saline 5 mL given intra-arterially through the sheath at the end of transradial procedure
16107804|NCT02105480|Device|Computer aided auscultation (CAA)|
16107805|NCT02105467|Drug|Grazoprevir 100mg / Elbasvir 50 mg FDC|
16107806|NCT02105467|Drug|Placebo to Grazoprevir / Elbasvir 50 mg FDC|
16107807|NCT02105454|Drug|Grazoprevir (GZR)|100 mg oral tablet (total daily dose)
16107808|NCT02105454|Drug|Elbasvir (EBR)|10 mg oral capsule (total daily dose = 5 capsules)
16107809|NCT02105454|Drug|Ribavirin (RBV)|200 mg oral capsule (total daily dose = 4-7 capsules)
16107810|NCT02105441|Device|Cochlear implant|Implantable hearing device
16107860|NCT02105064|Device|SHAM rTMS|Sham rTMS, without brain stimulation
16107861|NCT02105038|Other|Spinner knob|
16107862|NCT02105038|Other|No Knob|
16107811|NCT02105428|Behavioral|Aerobic Exercise Training|A progressive increase in duration, frequency and intensity so the last 8 weeks of exercise are performed for 60 min, 5 days per week and at 80% of aerobic capacity. The duration includes a 5 minute warm up and 5 minute cool down. All exercise will be performed on a stationary bicycle (i.e., cycle ergometer).
16107812|NCT02105415|Drug|Ketamine / Propofol Admixture|
16107813|NCT02105415|Drug|Etomidate|
16107814|NCT02105402|Behavioral|PROMPT|The PROMPT approach utilizes a motor-speech hierarchy (MSH) to guide speech language pathologists (SLP) in selecting speech movement goals for treatment. PROMPT treatment generally proceeds systematically in a bottom-up fashion starting with the lowest subsystem in the hierarchy where a child has control issues. Furthermore, in the PROMPT approach specific techniques are used to stimulate sensory input that are assumed to facilitate the formation of sensory-motor pathways required for the acquisition and accurate production of speech movement patterns. As the speech motor behaviors are established, the clinician reduces the number of cues and the frequency and immediacy of feedback and practices transfer and generalization activities.
16107815|NCT02105389|Behavioral|Individualized Yoga Intervention|
16107816|NCT02105376|Device|Trigeminal Nerve Stimulation (TNS)|Trigeminal Nerve Stimulation (TNS)
16107817|NCT02105363|Other|measure of skin movement on surface of the back|
16107818|NCT02105363|Other|Measurement of skin movement on surface of back|
16107819|NCT02105350|Drug|MEK 162|
16107820|NCT02105350|Drug|Gemcitabine|
16107821|NCT02105350|Drug|Oxaliplatin|
16107822|NCT02105324|Device|Bionic Pancreas|Automated blood glucose control via a closed-loop bionic pancreas device.
16107823|NCT02105324|Other|Usual Care|As a comparator control, usual diabetes camp care with the participant's own insulin pump.
16107824|NCT02105311|Device|Selective laser trabeculoplasty|Selective laser trabeculoplasty platform The Lumenis Selecta® Duet™ (Lumenis Ltd., Yokneam, Israel)
16107825|NCT02105311|Drug|Travoprost|Travoprost benzalkonium-free ophthalmic solution (40 microgram/ml) (Alcon Laboratories, Inc., Fort Worth, TX, USA)
16107826|NCT02105285|Drug|OPC-1085EL ophthalmic solution|
16107827|NCT02105285|Drug|Carteolol long-acting ophthalmic solution|
16107828|NCT02105272|Drug|OPC-1085EL ophthalmic solution|
16107829|NCT02105272|Drug|Latanoprost ophthalmic solution|
16107830|NCT02105259|Behavioral|Psychodynamic Internet Treatment|Psychodynamic Internet Treatment for patients social anxiety disorder
16107831|NCT02105259|Other|Waiting list|Waiting list, where participants wait for delayed treatment
16107832|NCT02105246|Behavioral|Referral to home-based cardiac rehab|Home-based cardiac rehab is a 12 week, home-based lifestyle intervention that includes counseling regarding heart healthy lifestyle changes.
16107833|NCT02105246|Behavioral|Referral to center-based cardiac rehab|Center-based cardiac rehab is a health center-based cardiac rehabilitation program that involves counseling in healthy heart behaviors and exercise delivered in a clinical setting.
16107834|NCT02105233|Biological|brain mimicking fluid|filled into the operation cavity during surgery for glioblastoma
16107835|NCT02105220|Other|Respiratory mechanics assessment|Data collection on respiratory mechanics, end expiratory lung volumes, gas exchanges, work of breathing. Data will be obtained by setting different end expiratory pressures and recording esophageal and airways pressure tracings.
16107836|NCT02105207|Other|Lung Ultrasound|Lung ultrasound evaluation is performed after clinical assessment and before chest radiography
16107837|NCT02105207|Other|Chest Radiography|Chest Radiography is performed after clinical evaluation without using ultrasound assessment
16107838|NCT02105194|Drug|Hyperbaric oxygen therapy|total body exposure to greater than atmospheric pressure oxygen
16107839|NCT02105181|Device|Placement of a FCMS in the biliary tract of the patients|During an ERCP procedure, a fully covered biliary metal stent (FCMS) is placed across a benign biliary stricture
16107840|NCT02105168|Procedure|Blood sample|Optional
16107841|NCT02105168|Procedure|Tumorous biopsy|Optional
16107842|NCT02105168|Procedure|Healthy material sample|Optional
16107843|NCT02105155|Drug|Conversion at day 7 ± 3 Prograf® to Advagraf®|Conversion from Prograf® (tacrolimus administered twice daily) to Advagraf® (once-daily prolonged-release tacrolimus) at day 7±3
16107844|NCT02105155|Drug|Conversion at day 90±5 Prograf® to Advagraf®|Conversion from Prograf® (tacrolimus administered twice daily) to Advagraf® (once-daily prolonged-release tacrolimus) at day 90±5
16107845|NCT02105142|Behavioral|ADHD Group Visits|Parents and children attend separate but concurrently run group visits every three months; groups are facilitated by general pediatricians
16107846|NCT02105142|Behavioral|ADHD Group Visits plus Online Discussion Portal|Parents and children attend separate but concurrently run group visits every three months; groups are facilitated by general pediatricians. Parent participants will be granted access to the online discussion portal to allow for communication in between in-person group visits.
16107847|NCT02105142|Behavioral|Computer Decision Support|ADHD Module of the Child Health Improvement through Computer Automation (CHICA) system Designed to facilitate physician adherence to clinical care guidelines for ADHD identification and chronic care management
16107848|NCT02105129|Drug|HMPL-523|HMPL-523: Oral administration with a single dose of 5, 20, 50, 100, 200 and 300 mg in Part A, followed by multiple doses of selected strength in Part B Other Name: NA
16107849|NCT02105129|Drug|Placebo|Oral administration
16107850|NCT02105116|Drug|fludarabine phosphate|Given IV
16107851|NCT02105116|Drug|cytarabine|Given IV
16107852|NCT02105116|Biological|donor lymphocytes|Undergo infusion of donor lymphocytes
16107853|NCT02105116|Other|laboratory biomarker analysis|Correlative studies
16107854|NCT02105116|Drug|G-CSF|Given IV
16107855|NCT02105103|Device|Accu-Chek® Insight Insulin Pump|A new insulin pump, the Accu-Chek® Insight insulin pump, will be used by all subjects enrolled in this study. The usability of the Accu-Chek® Insight insulin pump for the intended use has already been investigated in a Human Factor study. The study subjects may encounter the following potential risks of CSII therapy while participating in the study: Possible hypoglycemia; Possible hyperglycemia which might progress to ketosis and DKA; Infusion site reactions (bleeding, bruising, discomfort, pruritus, pain, plaster reactions, inflammation, infection etc.)
16107856|NCT02105090|Drug|Anesthetics, Local|
16107857|NCT02105090|Drug|Sodium Chloride 0.9%|
16107864|NCT02105012|Drug|BD MDI 160 µg|Budesonide Inhalation Aerosol administered as 2 inhalations BID
16107865|NCT02105012|Drug|BD MDI 80 µg|Budesonide Inhalation Aerosol administered as 2 inhalations BID
16107866|NCT02105012|Drug|BD MDI 40 µg|Budesonide Inhalation Aerosol administered as 2 inhalations BID
16107867|NCT02105012|Drug|Placebo MDI|Placebo MDI administered as 2 inhalations BID
16107868|NCT02104999|Device|Point-of-care test for CRP|Device: C Reactive Protein (CRP) measurement on capillary blood using a point-of-care test to determine the CRP level in the blood
16107869|NCT02104986|Drug|Velbe-Bleomycin-Cisplatin|Limitation of the number of chemotherapy courses (≤ 4) after the achievement of a clinical and biological response in NSMGCT patients treated with cisplatin-based chemotherapy, in order to reduce treatment long-term effects
16107870|NCT02104986|Drug|Vepeside-ifosfamide-Cisplatin|
16107871|NCT02104973|Behavioral|Lifestyle counseling|We will intent to modify the diet of the children. The intervention is designed to promote the increase the intake of fruits and vegetables and to reduce the high density foods consumption.
16107872|NCT02104960|Other|Dermatological clinical examination|Clinical pictures, Dermatoscopy, Elastography, Sebumetry
16107873|NCT02104960|Other|Biopsy|Skin biopsy for examinations by confocal microscopy ex vivo and histopathology
16107874|NCT02104960|Other|Confocal microscopy in vivo|Examination by confocal microscopy in vivo
16107875|NCT02104947|Drug|idarucizumab|idarucizumab
16107876|NCT02104934|Procedure|Adductor Canal Block|
16107877|NCT02104908|Procedure|paravertebral nerve|a lumbar, sacral plexus and paravertebral nerve block(LSP) group with 20ml 0.5% ropivacaine at lumbar plexus(level L3-4) , 10ml 0.5%ropivacaine at sacral plexus and 10ml 0.5%ropivacaine at paravertebral nerve(level L1).
16107878|NCT02104908|Procedure|lumbar and sacral plexus block|a lumbar and sacral plexus block(LS) group with 20ml 0.5% ropivacaine at lumbar plexus(level L3-4) and 10ml 0.5%ropivacaine at sacral plexus;
16107879|NCT02104895|Radiation|Accelerated partial breast irradiation (APBI)|Accelerated partial breast irradiation (APBI) using intensity modulated radiotherapy (IMRT)
16107880|NCT02104895|Radiation|Whole breast irradiation (WBI)|Conventional whole breast irradiation (WBI)
16107881|NCT02104882|Radiation|Intraoperative Radiotherapy (Applicator Surface Dose: 20-40 Gy)|
16107882|NCT02104869|Biological|Trivalent influenza vaccine (inactivated and fragmented).|
16107883|NCT02104856|Device|Alair System (Bronchial Thermoplasty)|
16107884|NCT02104843|Drug|Daclatasvir, Asunaprevir and BMS-791325 FDC|
16107885|NCT02104843|Drug|BMS-791325|
16107886|NCT02104843|Drug|Rosuvastatin|
16107887|NCT02104830|Biological|Empegfilrastim 6 mg|Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg.
16107888|NCT02104830|Biological|Filgrastim|Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir.
16107889|NCT02104830|Biological|Placebo №1|Placebo №1 is supplied as solution for injection 1.0 ml. Placebo №1 is to be administered 24 h after the chemotherapy at dose of 1.0.
16107890|NCT02104830|Biological|Placebo №2|Placebo №2 should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Placebo №2 is supplied as solution for injection 0.0083 ml/kg.
16107891|NCT02104830|Biological|Empegfilrastim 7.5 mg|Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 6 mg.
16107892|NCT02104817|Drug|Epanova® (omega-3 carboxylic acids)|Adjunct to statin therapy and diet in high risk adult patients for the prevention and reduction of major adverse cardiovascular events (MACE)
16107893|NCT02104817|Drug|corn oil control|corn oil control arm
16107894|NCT02104804|Drug|Saxagliptin 5mg|Saxagliptin 5mg (plus stable insulin dose), given orally once daily (24 weeks); subjects stratified by use of stable metformin dose; flexible insulin dose (as needed for rescue).
16107895|NCT02104804|Drug|Placebo for Saxagliptin|Placebo tablets (plus stable insulin dose), given orally once daily (24 weeks); subjects stratified by use of stable metformin dose; flexible insulin dose (as needed for rescue).
16107896|NCT02104791|Drug|procalcitonin|In patient with preterm premature rupture of membrane (PPROM) is the procalcitonin can be used to predict intra-amniotic subclinical infection?
16107897|NCT02104778|Drug|Dexamethasone|In dexamethasone group, dexamethasone 8 mg is added to 0.5% ropivacaine 20 ml for sciatic nerve block.
16107898|NCT02104778|Drug|Epinephrine|Epinephrine 1:200,000 is added to 0.5% ropivacaine 20 ml for sciatic nerve block
16107899|NCT02104765|Drug|LY2951742|Administered subcutaneously.
16107900|NCT02104765|Drug|Placebo|Administered subcutaneously.
16107901|NCT02104752|Drug|Curcumin|360 mg/day (divided into twice daily oral doses)
16107902|NCT02104752|Drug|Placebo|"Inactive, matched placebo (Sugar Pill)"
16107903|NCT02104739|Drug|Exenatide|Single subcutaneous injection (10 mcg)
16107904|NCT02104739|Drug|Saxagliptin|Single dose orally (5 mg)
16107905|NCT02104739|Drug|Exenatide extended-release (ER)|Subcutaneous injection (2mg) weekly for 6 weeks
16107906|NCT02104739|Other|Placebo|Placebo tablets and Placebo (normal saline) injections
16107907|NCT02104726|Other|Fluoroscopy guided steroid injection|We want to compare if there is a difference between the two arms, with the assumption that with fluoroscopy will deliver the steroid more accurately and see better outcomes.
16107908|NCT02104726|Other|Blind Steroid Injection|Want to compare it to fluoroscopy guided, with assumption that it will be less effective in reducing pain
16107909|NCT02104713|Biological|Allogeneic (MSC's) Application to the Burn Wounds|"Allogeneic (MSC's) Application to the Burn Wounds. The first group of 5 will be started on the lowest dose. If there are no adverse reactions, the second group of 5 will receive a higher dose. This will be repeated for the third and fourth groups with each receiving a higher dose
~Initial dose level will be 2.5 x 10³ Allogeneic MSCs cells/square cm.
~Second dose level 5 X 10³ Allogeneic MSCs cells/square cm.
~Third dose level 1 X 10⁴ Allogeneic MSCs cells/square cm.
~Fourth dose level 2 X 10⁴ Allogeneic MSCs cells/square cm.
~Up to 2 administrations of cells will be allowed per dose level to be given over a period of no more than 8 weeks. Each administration of cells will be no less than ten days apart and no more than 6 weeks apart."
16107910|NCT02104700|Drug|Rilpivirine/Emtricitabine/Tenofovir|Rilpivirine 25mg/Emtricitiabine 200mg/Tenofovir 300mg FDC qday
16107911|NCT02104687|Procedure|Flow group|After induction, each patient will obtain Transesophageal Dopplerometry probe (CardioQ) in order to monitor the parameters of CI, FTc, PV and SVR.
16107912|NCT02104687|Procedure|Press group|After induction, the parameters of MAP and CVP will be monitored in each of the patients.
16107913|NCT02104674|Drug|lebrikizumab|Given SC on Days 1, 29, and 57
16107914|NCT02104674|Drug|montelukast [Singulair]|10 mg given orally once daily for 12 weeks
16107915|NCT02104674|Other|placebo|SC injection given on Days 1, 29, and 57
16107916|NCT02104661|Drug|Oxcarbazepine|Oxcarbazepine 150mg tablet, over encapsulated and back-filled with Microcrystalline Cellulose/Magnesium Stearate 1%.
16107917|NCT02104661|Drug|Placebo|Placebo in a matched capsule containing Microcrystalline Cellulose/Magnesium Stearate 1%.
16107918|NCT02104648|Other|Placebo RO4602522|Daily oral doses
16107919|NCT02104648|Drug|RO4602522|Daily oral doses
16107920|NCT02104648|Drug|RO4602522|Single, oral dose
16107921|NCT02104648|Drug|moxifloxacin|400 mg oral dose given on Day 1 or 11
16107922|NCT02104648|Other|moxifloxacin placebo|Dose given orally on Days 1 and/or 11
16107923|NCT02104635|Behavioral|Delivery of a Post-Partum Package|
16107924|NCT02104622|Device|ReWalk Rehabilitation 2.0|
16107925|NCT02104609|Drug|Levonorgestrel 1.5mg by mouth once|Levonorgestrel 1.5mg by mouth given on menstrual cycle day 8
16107926|NCT02104596|Device|Xylitol|
16107927|NCT02104583|Drug|Eleclazine|Eleclazine tablets administered orally
16107928|NCT02104583|Drug|Placebo to match eleclazine|Placebo to match eleclazine tablets administered orally
16107929|NCT02104570|Other|Kinesio taping with tension|
16107930|NCT02104570|Other|Kinesio taping without tension|
16107931|NCT02104570|Other|Fatigue protocol|
16107932|NCT02104557|Other|Non intervention|Non intervention
16107933|NCT02104557|Other|Non intervention|Non intervention
16107934|NCT02104505|Drug|Gamma Tocopherol 700 mg capsules,|2 capsules daily
16107935|NCT02104505|Drug|Placebo|Safflower oil capsules
16107936|NCT02104492|Other|a 12-week Respiratory Muscles Training Program (RMTP)|Every session will be lasted 50 minutes and performed under supervision of a physiotherapist. It will be comprised of 30 minutes of progressive aerobic training program followed by peripheric resistive muscle training program which will be supplemented by a 12-week Respiratory Muscles Training Program (RMTP) with ORYGEN Dual® device for 20 minutes. Patients will be instructed to maintain adequate inspiration and expiration while using the Origen-Dual® valve at a rate of 15-20 breaths/minute. Participants will be performed five sets of 10 repetitions followed by 1-2 minutes of unloaded recovery breathing off the device, once a day, 2 days per week, for 12 weeks. The respiratory muscles training will be begun at 30% of MIP achieved at baseline and increased by 5% each week to reach 60% of the baseline assessment MIP.
16107937|NCT02104492|Other|Active Comparator|Every session will be comprised of 30 minutes of progressive aerobic training program followed by peripheric resistive muscle training program and Health Education Program.
16107938|NCT02104466|Procedure|Acupuncture|Acupuncture will be delivered in a group setting, in a common space with multiple reclining chairs. The initial acupuncture treatment will include a one-on-one diagnostic interview with one of the study acupuncturists for up to 30 minutes, followed by administration of acupuncture needles retained for 20-40 minutes. For subsequent group acupuncture treatments, participants will have a 10-15 minute diagnostic intake with the acupuncturist, followed by administration of acupuncture needles retained for 20-40 minutes. Eight to twelve needles will be administered in acupuncture points selected based on a treatment manual developed for the study. All treatments will be administered using sterile, disposable, surgical stainless steel acupuncture needles.
16107939|NCT02104453|Procedure|airway maneuver|"Three-period crossover study: During general anesthesia induction, subjects are assigned to one of the 6 airway maneuver sequences (ABC, CAB, BCA, ACB, CBA, or BAC) in accordance with a randomization schedule. Each maneuver is performed 5 times in a period.
~Airway maneuver A: E-C clamp mask holding technique; Airway maneuver B: two-handed mask ventilation with jaw thrust airway maneuver; Airway maneuver C: two-handed mask ventilation with triple airway maneuver(combine jaw thrust and head tilt chin lift)"
16107940|NCT02104440|Biological|"Sequential infusion of allogeneic mesenchymal stem cells expanded in vitro"|
16107941|NCT02104427|Drug|TG-0054 combined with G-CSF|
16107942|NCT02104414|Drug|Exparel|266 mg/20mL Exparel (to be diluted with 10 mL sterile saline to make 30 mL)
16107943|NCT02104414|Drug|Bupivacaine HCl with Epinephrine|75mg/30mL 0.25% Bupivacaine HCl with epinephrine
16107944|NCT02104414|Drug|Normal Saline|30mL Normal Saline
16107945|NCT02104401|Device|tDCS|tDCS will be applied with a Soterix CT tDCS Device with a HD-tDCS 4x1 Multi-Channel Stimulation Interface. During stimulation, a low level of constant DC electrical current (1-2 mA) will be applied via the electrodes. Current will be ramped up over 10-60 seconds, and typically causes very mild tingling and itching sensations. The current will be applied for no more than 20 minutes per session, at which time the current is ramped down over 10-60 seconds. Subjects will be seated in a chair throughout tDCS administration. Subjects will receive tDCS 5 days/week for 4 weeks.
16107946|NCT02104388|Drug|SJP-0035 Ophthalmic Solution|
16107947|NCT02104388|Drug|Vehicle of SJP-0035 Ophthalmic Solution|
16107948|NCT02104375|Dietary Supplement|L-citrulline|2 weeks of L-citrulline supplementation (6g/day).
16107949|NCT02104362|Radiation|exclusive single-fraction irradiation|
16107950|NCT02104349|Behavioral|Mindfulness meditation|One hour training with mindfulness instructor. Listening to mindfulness CD twice a day for 2 weeks prior to spine surgery. Post-operative practice will be at least 1 track per day.
16107951|NCT02104336|Drug|EPI-743|EPI-743 is the quinone oxidation product of alpha-tocotrienol
16107952|NCT02104323|Drug|Endostatin|Method of drug administration:continuous intravenous pumping; Dosage: 7.5mg/m2/d; Course of treatment: 3 months;Total three treatment courses.
16107953|NCT02104310|Drug|Fluorine-18-L-dihydroxyphenylalanine|5 millicuries ± 10%; Intravenous injection; 1 time
16107954|NCT02104297|Drug|deksmedetomidine|deksmedetomidine infused during operation 0.2 mcg/kg/hour
16107955|NCT02104297|Drug|Remifentanil|Remifentanil infused during operation 0.2 mcg/kg/min
16108077|NCT02103296|Procedure|Drawing admission labs from cord blood|
16107956|NCT02104297|Drug|Saline|During operation saline infused equal volüme of deksmedetomidine and remifentanil
16107957|NCT02104284|Procedure|methacholine and mannitol bronchial challenge tests|"Airway hyperresponsiveness is a common feature of asthma. Methacholine and mannitol are two representative agonists for bronchial challenge. They have theoretically different mechanisms of action, and may have different diagnostic properties. However, their difference has not been directly evaluated among Korean adults. In this study, we compare the diagnostic properties of methacholine and mannitol bronchial provocation tests.
~Asthmatic patients and non-asthmatic controls were recruited prospectively from four referral hospitals in Korea. Participants were challenged with each of methacholine and mannitol inhalation on different days. Their diagnostic utility was evaluated by calculating their sensitivity, specificity, positive/negative predictive values for asthma diagnosis."
16107958|NCT02104271|Procedure|Argon Plasma Coagulation|"APC was performed during sigmoidoscopy exam. Bowel preparation begins on the eve of the exam associated with waste liquid diet without oral intake of 10mg of bisacodyl (5mg/dragee) at 14 o'clock and 18pm and 130ml of phosfoenema (16g of sodium phosphate monobasic monohydrate and 6g of sodium phosphate dibasic heptahydrate per 100ml) diluted in 100ml of orange juice or lemon to 19h. On the day of the exam is administered 130ml of phosfoenema rectally immediately before the exam.
~All patients were previously sedated with fentanyl (0.05mg/ml), midazolam (5mg/5ml) and propofol (10mg/ml) and have intravenous introduction of the flexible colonoscope to the transverse colon to the exchange of gases following the routine of the Department of Endoscopy, Cancer Hospital Barretos."
16107959|NCT02104271|Procedure|Historical control|"APC was performed during sigmoidoscopy exam. Bowel preparation begins on the eve of the exam associated with waste liquid diet without oral intake of 10mg of bisacodyl (5mg/dragee) at 14 o'clock and 18pm and 130ml of phosfoenema (16g of sodium phosphate monobasic monohydrate and 6g of sodium phosphate dibasic heptahydrate per 100ml) diluted in 100ml of orange juice or lemon to 19h. On the day of the exam is administered 130ml of phosfoenema rectally immediately before the exam.
~All patients were previously sedated with fentanyl (0.05mg/ml), midazolam (5mg/5ml) and propofol (10mg/ml) and have intravenous introduction of the flexible colonoscope to the transverse colon to the exchange of gases following the routine of the Department of Endoscopy, Cancer Hospital Barretos."
16107960|NCT02104258|Other|Physiotherapy ASPETAR|Standardized physiotherapy protocol
16107961|NCT02104258|Other|Physiotherapy ASPETAR+|Standardized physiotherapy protocol including early lengthening exercises
16107962|NCT02104245|Drug|Ciprofloxacin dispersion for inhalation|
16107963|NCT02104245|Drug|Placebo|
16107964|NCT02104232|Behavioral|THPP-I|
16107965|NCT02104232|Behavioral|EUC|
16107966|NCT02104193|Drug|simvastatin in addition to radiation therapy|simvastatin 80 mg tablet once daily during the radiation therapy period in addition to radiation therapy 30 Gy delivered in 10 fractions over 2 weeks
16107967|NCT02104193|Radiation|radiation therapy|radiation therapy 30 Gy delivered in 10 fractions over 2 weeks
16107968|NCT02104180|Device|Urgotul|sterile, hydrocolloid dressing, that consist of a polyester fabric coated with hydrocolloid particles and vaseline
16107969|NCT02104180|Device|TulleGras M.S.|Sterile dressing that consists of viscose tissue coated with mineral vaseline
16107970|NCT02104167|Device|ROIC interbody cage with VerteBRIDGE plating|
16107971|NCT02104154|Device|Samsung LABGEO PT10 Hepatic Panel|
16107972|NCT02104141|Device|ROIA Interbody Cage with VerteBRIDGE plating|
16107973|NCT02104128|Drug|Bupropion|Bupropion MR will be given open label to all participants in the depression group. Participants will receive 150mg od for one week. The dose will then be increased to 150mg bd for the following 5 weeks. Participants in the control group will recieve no drug. Note that the study is not assessing the safety or efficacy of buprion-- it is using bupropion to assess the neural effects of altering central dopaminergic function in depressed patients.
16107974|NCT02104115|Other|MRI scanners|
16107975|NCT02104115|Other|VAS Symptom scores|
16107976|NCT02104102|Other|Mirror Therapy|Mirror Therapy, which is based on the activation of mirror neurons from the illusion generated by viewing the reflection of a member in a mirror, that is, intended to facilitate the movement through the practice of bilateral symmetric activities, since it is able to stimulate cortical plasticity, promoting reversal of the decrease and the reestablishment of motor function.
16107977|NCT02104102|Other|Kinesiotherapy|Hands movements.
16107978|NCT02104089|Device|Zenith® t-Branch™ Thoracoabdominal Endovascular Graft|Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guide the study device(s) into place in the aorta.
16107979|NCT02104076|Device|Evolution® Biliary Stent-Fully Covered|Implantation of the Evolution® Biliary Stent-Fully Covered in the common bile duct utilizing ERCP
16107980|NCT02104063|Procedure|MRI-PET|Participants will have an MRI-PET scan (the Index test) in addition to the procedures they would normally receive as their standard of care (Reference tests). The accuracy of MRI-PET in detecting or ruling out metastatic penile cancer will be compared to the reference tests.
16107981|NCT02104050|Drug|Placebo Gel|6 mL of Placebo Gel administered TID for 6 weeks
16107982|NCT02104050|Drug|OLT1177 Gel|6 mL of OLT1177 Gel (5%) administered TID for 6 weeks
16107983|NCT02104037|Procedure|Lumbar puncture|
16107984|NCT02104024|Other|Contrast Enhanced Ultrasound Scanning|
16107985|NCT02104011|Drug|Propranolol|
16107986|NCT02103998|Drug|thryoid hormone T4 + oral potassium iodide (KI) for 42 days|Continuous infusion of 4 µg/Kg/day T4 with 30 µg/Kg/day oral potassium iodide (KI) for 42 days
16107987|NCT02103998|Drug|D5W - 5% dextrose water|Equivalent volume of infusion as study drug
16107988|NCT02103985|Drug|JNJ-39823277|Participants will receive 100 mg of JNJ-39823277 tablet orally (by mouth) as a single dose.
16107989|NCT02103972|Dietary Supplement|GM080|
16107990|NCT02103972|Dietary Supplement|Maltodextrin|
16107991|NCT02103959|Drug|CMX-2043|Slow bolus IV administration of CMX-2043
16107992|NCT02103959|Drug|Placebo comparator|Slow bolus IV administration of PBS
16108078|NCT02103296|Procedure|Drawing admission labs from infant blood|
16108079|NCT02103283|Drug|Teprotumumab|Teprotumumab 20mg/kg administered by intravenous infusion every 3 weeks for 3 infusions
16108263|NCT02101892|Drug|Amitriptyline|per os, daily, evening
16107993|NCT02103946|Procedure|Serratus Anterior Muscle Plane block (SAM block)|The US probe is placed in the mid-axillary line at level of the 6th intercostal space. From caudal to cranial, an in-plane approach, the block needle is inserted until the tip is placed between SAM and intercostal muscles and the LA injection will be visualized in real-time. The injection usually consists of 0.4ml/kg of bupivacaine 0.25% plus adrenaline (5ug/ml). Intraoperatively, all subjects will receive a general anesthetic using inhaled anesthetic and oxygen. Intravenous fentanyl will be administered for cardiovascular stability to noxious stimuli.For postoperative analgesia, all subjects will receive oral acetaminophen. Patients will receive a ketorolac IV injection then morphine as a rescue analgesic for breakthrough pain.
16107994|NCT02103946|Procedure|Paravertebral Block|After skin preparation and sterile draping applied. Target paravertebral space will be located using US guidance. The paravertebral space between the third and fourth thoracic vertebrae will be identified in a parasagittal view approximately 3 cm lateral to midline on the side of surgery. A local anesthetic skin wheal will be raised caudal to the ultrasound transducer. A 17-gauge, Tuohy-tip needle will be inserted through the skin wheal in-plane beneath the ultrasound transducer and directed to the paravertebral space. Normal saline (5 mL) will be injected via the needle to help identify the paravertebral space and observe the pleura being displaced anteriorly. 0.4 ml\kg of 0.25% Bupivacaine with epinephrine, 5 μg/mL, will be slowly injected with gentle aspiration every 3 mL.
16107995|NCT02103907|Other|Targeted dynamic balance training|Participants in this study group will complete dynamic balance training exercises four times per week, for ten weeks. Exercise sessions at the university will last approximately one hour, and home exercise sessions will take approximately 30 minutes to complete. Exercises will emphasize dynamic balance control, muscle strength and proprioception and will be progressed over three phases during the ten weeks (with more difficult exercises phased in, and exercises that have been mastered phased out).
16107996|NCT02103894|Drug|[18F]T807 ([18F]MNI-777)|All enrolled subjects will undergo an [18F]MNI-777 PET imaging visit. For individuals with AD or CTE, [18F]florbetapir imaging may also be performed to serve as a means of correlating disease severity by evaluating the relationship of β-amyloid uptake (measured by [18F]florbetapir imaging) and tau protein uptake (measured by [18F]MNI-777 PET imaging). For individuals with Parkinsonian symptoms, [123I]β-CIT SPECT imaging may be performed to evaluate for a reduction in dopamine transporter uptake.
16107997|NCT02103881|Drug|Ketamine|500 mg of intramuscular ketamine for severe pre-hospital agitation
16107998|NCT02103881|Drug|Haloperidol|Haloperidol 10 mg intramuscular for severe prehospital agitation.
16107999|NCT02103868|Behavioral|Tobacco Cessation Counseling|Doing group and personal counseling for tobacco cessation
16108000|NCT02103855|Drug|Belatacept|
16108001|NCT02103842|Drug|Omega-3 fatty acids|
16108002|NCT02103829|Behavioral|Brief Intervention #1|Brief online suggestion intended to increase the likelihood of quitting smoking that takes less than 1 minute to complete.
16108003|NCT02103829|Behavioral|Brief Intervention #2|Brief online suggestion intended to increase the likelihood of quitting smoking that takes less than 1 minute to complete.
16108004|NCT02103829|Behavioral|Brief Intervention #3|Brief online suggestion intended to increase the likelihood of quitting smoking that takes less than 7 minutes to complete.
16108005|NCT02103816|Device|SmartLipo Triplex laser system along with the SideLaze800 hand piece|
16108006|NCT02103790|Device|Home NIV installation|
16108007|NCT02103777|Drug|Caffeine citrate|Caffeine will be given by either high dose in Arm 1 or low dose in Arm 2
16108008|NCT02103764|Drug|Desogestrel|Desogestrel Dosage form : Desogestrel 150 mcg/capsule Dosage : 150 mcg/day Frequency : 1 capsule/day before bed time Duration: 10 day/month
16108009|NCT02103764|Drug|Medroxyprogesterone acetate|Medroxyprogesterone acetate Dosage form : 10 mg./capsule Dosage : 10 mg./day Frequency : 1 capsule/day before bed time Duration : 10 day/month
16108010|NCT02103738|Other|0.5 mg Ranibizumab intravitreal injections|All eligible patients will initially be treated in a fixed loading phase, consisting of one intravitreal injection of Ranibizumab 0.5 mg per month for 3 consecutive months (Day 1, Month 1, and Month 2). After the loading phase, patients will be treated according to the treatment arm to which they have been assigned, either a continued once monthly dosing regimen, or an extended schedule of Ranibizumab intravitreal injections as described below. The planned duration of total treatment is 24 months.
16108011|NCT02103725|Drug|pimecrolimus 10 mg/g cream|
16108012|NCT02103725|Drug|Vehicle cream|
16108013|NCT02103712|Other|Qualitative|
16108014|NCT02103699|Drug|No intervention|This is an observational study. Patients receiving simeprevir (single capsule of 150 mg once daily) as prescribed by the health care provider will be observed.
16108015|NCT02103686|Drug|Lyrica|
16108016|NCT02103686|Drug|Experimental drug|sustained release formulation of pregabalin
16108017|NCT02103686|Dietary Supplement|High fat meal|
16108018|NCT02103686|Dietary Supplement|fasted|
16108019|NCT02103673|Drug|DAOIB|Intervention drug: DAOIB. Dosage: 250-1500 mg/day by mouth. Duration: 6 weeks
16108020|NCT02103673|Drug|Placebo|Intervention drug: placebo by mouth. Duration: 6 weeks
16108021|NCT02103660|Drug|Depo-Medroxyprogesterone Acetate|150 mg Depo-Medroxyprogesterone Acetate administered every 13 weeks
16108022|NCT02103660|Drug|Progestin Contraceptive (Jadelle)|2 implants containing 75 mg of levonorgestrel will be implanted and will last for up to 5 years
16108023|NCT02103647|Drug|Immediate release capsule(lyrica 150mg * 2/day)|Immediate release capsule
16108024|NCT02103647|Drug|sustained release tablet|sustained release tablet
16108025|NCT02103634|Device|NaF PET/MRI|
16108026|NCT02103634|Device|NaF PET/CT|NaF PET/CT images will be obtained through fusion software. Researchers will fuse the Non AC and AC NaF images with the low dose CT obtained in the FDG PET/CT study.
16108027|NCT02103634|Device|FDG PET/CT|
16108028|NCT02103621|Behavioral|Unified Protocol (UP)|
16108029|NCT02103621|Behavioral|Taper and Monitoring (TAP-M)|
16108030|NCT02103608|Device|Glide|6 facial hair reduction treatments with the Glide device, two weeks apart.
16108031|NCT02103595|Device|Accu-Chek FlexLink|Insulin pump device used for 4-weeks under real life conditions
16108032|NCT02103595|Device|Accu-Chek FlexLink Plus|Insulin pump device used for 4-weeks under real life conditions
16108156|NCT02102737|Procedure|clamp|hyperinsulinemic euglycemic clamp
16108033|NCT02103582|Other|Intervention|Participants who are randomized to the 'intervention arm' will be asked to come to the study site to exercise 3 days per week for 12 weeks. The exercise duration will increase over time from 75 minutes per week to 150 minutes per week. Intervention participants will have anthropometric measurements of weight, height, hip size and waist size taken at the beginning of the study, 6 weeks, and at 12 weeks. Intervention participants will also have a fitness test on a treadmill, full body scan, blood pressure, heart rate and questionnaires given at the beginning of the study, 6 weeks and at 12 weeks.
16108034|NCT02103569|Drug|FDC of Daclatasvir, Asunaprevir and BMS-791325|
16108035|NCT02103569|Drug|FDC of Norethindrone and Ethinyl Estradiol|
16108036|NCT02103569|Drug|BMS-791325|
16108037|NCT02103556|Other|Mineral oil|4 ml daily (adjusted as needed), for 4 weeks
16108038|NCT02103556|Dietary Supplement|Olive oil|4 ml daily (adjusted as needed), for 4 weeks
16108039|NCT02103556|Dietary Supplement|Flaxseed oil|4 ml daily (adjusted as needed), for 4 weeks
16108040|NCT02103543|Other|physical therapy|physical therapy consisting of core strengthening, low back stretching and range of motion 3 sessions
16108041|NCT02103543|Procedure|lumbar interlaminar epidural steroid injection|single lumbar interlaminar epidural steroid injection
16108042|NCT02103543|Drug|epidural steroid injection|Dexamethasone 10mg or Depomedrol 40mg, together with Bupivacaine 0.25% (for 3-5mL total injectate volume)
16108043|NCT02103530|Other|FLT PET/CT|All PET/CT scans were performed using a hybrid PET/CT scanner (Gemini TF 64 with Astonish TF, Philips). F-18 FLT (2.96 MBq/kg) in 2-5 mL of normal saline was injected intravenously. One hour after FLT injection, CT began at the vertex and progressed to the upper thigh (120 kVp, 100 mA and 4 mm slice thickness). PET emission data were acquired immediately for 1 min at each bed position followed. The CT data were used for attenuation correction. Images were reconstructed using a standard ordered-subset expectation maximization algorithm with 3 iterations and 33 subsets.
16108044|NCT02103517|Dietary Supplement|Omega -3 fatty acids|Each subject assigned to active treatment group will receive 4 g/day capsule of omega-3 fatty acids.
16108045|NCT02103517|Dietary Supplement|Placebo: Corn oil|Each subject assigned to the control group will receive 4 g/day capsule of corn oil.
16108046|NCT02103504|Device|DePuy Attune posterior stabilized fixed bearing total knee replacement|
16108047|NCT02103491|Dietary Supplement|Salt administration|Participants were provided with 3 plastic bags each one containing 4 white capsules (e.g., a total of 12 capsules). In the salt group, the capsules were filled with a commercially available product that contains buffered electrolyte salts (Saltstick caps, Saltstick, California US). The total amount of electrolytes provided in the salt group was: 2580 mg of sodium (113 mmol), 3979 mg of chloride (112 mmol), 756 mg of potassium (19.3 mmol) and 132 mg of magnesium (5.4 mmol). In the control group, participants received the same number of capsules with the exact same appearance but filled with an isocaloric placebo (cellulose). All the participants were instructed to ingest the contents of the first bag in the transition between the swimming and cycling sections, the second bag around the middle of the cycling leg and the third bag during the transition between the cycling and running sections.
16108048|NCT02103491|Dietary Supplement|Placebo administration|
16108049|NCT02103478|Drug|ASTX727 Dose Escalation|Oral investigational product and approved IV decitabine
16108050|NCT02103478|Drug|ASTX727 Dose Confirmation|Randomization cross over design for courses 1 and 2
16108051|NCT02103478|Drug|ASTX727 Fixed-Dose Combination|Fixed-dose investigational product
16108052|NCT02103465|Drug|Rotigotine|transdermal patch
16108053|NCT02103465|Drug|Placebo|transdermal patch
16108054|NCT02103452|Procedure|Ovarian and endometrial samples|Ovarian and endometrial samples were evaluated by hematoxlin &amp;eosin for histopathology (HP) and of oct-4 for immunohistochemistry (IH) for SCE
16108055|NCT02103439|Drug|Algeron|1.5 µg/kg of body weight subcutaneously, once a week
16108056|NCT02103439|Drug|PegIntron|1.5 µg/kg of body weight subcutaneously, once a week
16108057|NCT02103426|Drug|ASP0113|intramuscular injection
16108058|NCT02103426|Drug|Placebo|intramuscular injection
16108059|NCT02103413|Device|EUS-BD|When the ERCP was unsuccessful, we tried one-step EUS-BDS using a linear-array echoendoscope (GF-UCT 240-AL 10 or AL 5, Olympus Medical Systems, Tokyo, Japan) at the same ERCP unit on the same session. EUS-BDS was performed by EUS-guided choledocoduodeostomy (EUS-CD) or EUS-guided hepaticogastrostomy (EUS-HG) at the discretion of involved endosonographers. Based on our modified protocol from two our proposed protocols, EUS-BD with transmural stenting was only considered.
16108060|NCT02103413|Device|PTBD|PTBD was performed in selected patients with an 8.5F catheter inserted under fluoroscopic or ultrasound guidance by experienced interventional radiologists or endoscopists.
16108061|NCT02103400|Other|Experimental group|Exercise Training Group
16108062|NCT02103400|Other|Control group|Exercise control group
16108063|NCT02103387|Behavioral|Cognitive Behavioral Training|Cognitive Behavioral Training [CBT] (stress awareness, cognitive restructuring, coping skills training, interpersonal skills training)
16108064|NCT02103387|Behavioral|Relaxation Training|Relaxation Training [RT] (muscle relaxation, deep breathing, guided imagery, meditation)
16108065|NCT02103387|Behavioral|Health Education Control|Health Education control condition (information about breast cancer diagnosis and treatment, side-effect management, recurrence, physical activity and nutrition, and life after breast cancer)
16108066|NCT02103374|Drug|Atrovent + Bricanyl or Atrovent + Ventoline|3 daily inhalations of Atrovent mixture to form Bricanyl or Ventolin form during 48 weeks
16108067|NCT02103374|Drug|Placebo|1 capsule lactose during 48 weeks
16108068|NCT02103361|Drug|Ustekinumab|
16108069|NCT02103361|Drug|Guselkumab|
16108070|NCT02103335|Drug|pomalidomide|Oral Pomalidomide, days 1-21 of 28 day cycle, dose 3 to 4 mg
16108071|NCT02103335|Drug|marizomib|IV Marizomib, 0.2 to 0.5 mg/m2 on days 1, 4, 8, 11 of 28 day cycle
16108072|NCT02103335|Drug|low-dose dexamethasone|Oral Dexamethasone, days 1, 2, 4, 5, 8, 9, 11, 12, 15, 16, 22, 23 of 28 day cycle, 5 or 10 mg
16108073|NCT02103322|Drug|Imatinib Mesylate Tablets, 400 mg|Brown, oval, scored, film coated, beveled edge tablet. Debossed with AN on scored side and 795 on the other side.
16108074|NCT02103322|Drug|Imatinib Mesylate Tablets, 400 mg|"Very dark yellow to brownish orange, film-coated tablets, ovaloid, biconvex with bevelled edges, debossed with 400 on one side with score on the other side, and SL on each side of the score."
16108080|NCT02103270|Drug|Peanut Protein 4,000mg|"Arm A will be defined as clinically tolerant if there is no clinical reactivity at the Week 104 and Week 117 DBPCFC. Clinical reactivity is defined as any reaction ≥ Grade 1 based on the Bock's Criteria (Appendix 4). Individuals in Arm A who meet the definition of clinically tolerant will continue to avoid peanut protein (i.e. continue on 600 mg per day of oat flour) as long as each subsequent DBPCFC (performed every 13 weeks until end of study) shows no clinical reactivity."
16108081|NCT02103270|Drug|Oat Flour|"Arm C will be defined as natural loss of responsiveness if they show no clinical reactivity at DBPCFCs (week 117 to end of study)."
16108082|NCT02103270|Drug|Peanut Protein 300 mg|"Arm B will be defined as desensitized to a minimum of 300 mg per day of peanut protein if they show no clinical reactivity at DBPCFCs (week 117 to end of study)."
16108083|NCT02103257|Drug|Sequential Icotinib Plus Chemotherapy|Sequential icotinib plus chemotherapy: pemetrexed 500mg/m2 iv d1, cisplatin 75mg/m2 d1, icotinib 125 mg is administered orally three times per day d 8-21, every 3 weeks for a cycle. After receiving a maximum of 4 cycles treatment, non-progressive patients continue to receive icotinib as maintenance treatment until disease progression or intolerable toxicity.
16108084|NCT02103257|Drug|Icotinib|Icotinib 125 mg is administered orally three times per day until disease progression or intolerable toxicity.
16108085|NCT02103244|Drug|Carboplatin|carboplatin will be dosed according to newly developed dosing algorithm.
16108086|NCT02103218|Behavioral|Education, activities, empowerment, racial pride building|Intervention focuses on information aimed toward reducing or preventing risky sex behaviors of minority adolescent females.
16108087|NCT02103218|Behavioral|General Health education, activities|Intervention focuses on information regarding general health knowledge and healthy behaviors (not including sex).
16108088|NCT02103205|Dietary Supplement|Formula with low iron concentration (2 mg/L) supplemented with bovine lactoferrin|
16108089|NCT02103205|Dietary Supplement|Formula with low iron concentration (2mg/L) without lactoferrin|
16108090|NCT02103205|Dietary Supplement|Formula with normal iron concentration (8 mg/L) without lactoferrin|
16108091|NCT02103192|Other|Anti-Oxidant Drink|
16108092|NCT02103179|Procedure|surgical treatment|all the patients in the study must have been treated by the surgery at the first time and have been confirmed as 'complete section' by the post-surgery radiological image.
16108093|NCT02103166|Drug|Hyoscine bromide|20 mg of hyosine bromide diluted in 100 ml of physiological serum (0.9% NaCl).
16108094|NCT02103166|Drug|Physiological serum|100 ml of physiological serum (0.9% NaCl).
16108095|NCT02103153|Device|Picosure Laser System|
16108096|NCT02103140|Behavioral|Facility-based Exercise|Supervised Facility-Based Exercise Intervention Arm The participants randomized to the exercise group will be required to meet and maintain a goal of 150 min/wk of moderate intensity exercise for 6 months. This intervention will use heart rate and rating of perceived exertion (RPE) to define moderate intensity. Participants will exercise for the prescribed duration at a heart rate in the range of 45-65% of their maximal oxygen consumption (VO2 max), as determined during baseline testing, and with an RPE in the range of 11-14 on the 20-point scale. The exercise will primarily utilize treadmills and exercise bikes.
16108097|NCT02103140|Behavioral|Home-based Exercise|Home-Based Exercise Intervention Group The participants randomized to this intervention arm will be required to meet and maintain a goal of 150 min/wk of moderate intensity exercise for 6 months, the same as the supervised intervention group. Their exercise goal will be to achieve a total of 10,000 steps per day, as measured by pedometers. Participants will be required to have a cell phone with text messaging capabilities.
16108098|NCT02103127|Device|755nm Alexandrite laser with lens array|
16108099|NCT02103114|Drug|Anti-thrombin III|"Intraoperatively- (correcting to 100%) according to the following formula:
~Units required = ((100%- baseline ATIII level*%) X body weight)/1.4
~expressed as a % normal level based on functional ATIII assay"
16108100|NCT02103114|Other|Placebo|Normal saline placebo
16108101|NCT02103101|Other|Measurement of Plasma Concentrations of NOACs|Plasma concentrations of dabigatran, rivaroxaban or apixaban will be measured using High Performance Liquid Chromatography (HPLC) coupled with tandem mass spectrometry (MS/MS). Blood samples will be taken in an EDTA tube and rapidly centrifugated. Plasma will be aliquoted and frozen at minus 80 degrees Celsius for later analysis.
16108102|NCT02103101|Genetic|Identification of ABCB1 polymorphisms coding for P-gp|To investigate the existence of a relation between polymorphisms of ABCB1 and plasma concentrations of new oral anticoagulants, the SNaPshot® Multiplex System will be used enabling multiplexing of SNPs (single nucleotide polymorphisms) of the ABCB1 gene (namely rs4148738, rs2235046, rs1128503, rs10276036, rs1202169, rs1202168, rs1202167).
16108103|NCT02103088|Behavioral|Sexual and urological intervention|Sexual and urological intervention consisting of: i) DVD instruction in pelvic floor muscle training ii) group instructions in pelvic floor muscle training by physiotherapist including three individually follow-up and ii) up to six couple sessions performed by a sexual nurse counselor.
16108104|NCT02103075|Device|Neuromuscular electrical stimulation|All groups received an accumulated 30-minute NMES (25 Hz, on/off: 800ms/800ms) intervention on median nerve.
16108105|NCT02103062|Drug|ABI-007|
16108106|NCT02103049|Drug|Ezetimibe|Patients on standard immunosuppressive therapy with statin will be added ezetimibe for 6 months. Thereafter ezetimibe will be discontinued for three months. Biochemical parameters will be analysed at the time of enrolment, after 3 months, 6 months and 9 months.
16108107|NCT02103036|Procedure|Core Stability Exercises (CSE)|The increase in intra-abdominal pressure stiffens and strengthens the relevant structural support around the spine, compacts the arthrogenic structures and in combination with abdominal contraction, it can encourage a rigid cylinder and stiffness to occur around the spine. The relevant anatomy in these type of exercises are deep muscles like transversus abdominous, multifidus or pelvic floor. The participants will have to do 10 different exercises. They will have to perform from 8 to 10 repetitions of every exercise, guided by a physical therapist. They will be recommended about making some series more at home, three days a week, when the treatment was finished.
16108157|NCT02102724|Dietary Supplement|Fish oil that contains omega-3 fatty acids|Fish oil gelcaps that contain 800 mg of EPA, 600 mg of DHA, 200 mg other omega-3 fatty acids
16108158|NCT02102724|Dietary Supplement|Placebo|Gelcaps that contain 1 gram of oleic sunflower oil
16108159|NCT02102711|Dietary Supplement|Vitamin A oral drops|
16108160|NCT02102698|Drug|Ecopipam|Ecopipam is a selective antagonist of the dopamine D1 receptor family.
16108108|NCT02103036|Procedure|Traditional Back School|The back school exercises are based in the traditional activity used for improve the back pain symptoms using the breathing with the stretching of the trunk muscles, the erector spinae reinforcement, the abdominal reinforcement or the postural movements. The participants will have to do 10 different exercises. They will have to perform from 8 to 10 repetitions of every exercise, guided by a physical therapist. They will be recommended about making some series more at home, three days a week, when the treatment was finished.
16108109|NCT02103036|Device|TENS|"Used equipment: MEGASONIC 313 P4 (Carin). Application program number 15: analgesic TENS with stimulation of afferent fibers.
~Type of current: two-phase TNS. Width of the impulse: 70µs. Frequency of the impulse: 100Hz. Train: Not. Pause / pause activates: Not. Time of treatment: 20 minutes."
16108110|NCT02103036|Device|Infra-red|Used equipment: INFRA - 2000 (Enraf Nonius) with the following parameters: 230 V / 50-60 Hz / 1.2 A
16108111|NCT02103023|Drug|Imiquimod ointment|5% 250mg imiquimod ointment
16108112|NCT02103023|Drug|Aqueous cream|aqueous cream
16108113|NCT02103023|Biological|Intradermal influenza vaccine|intradermal trivalent influenza vaccine (Intanza15)
16108114|NCT02103023|Biological|Intramuscular influenza vaccine|intramuscular trivalent influenza vaccine (Vaxigrip)
16108115|NCT02102984|Device|covered biliary stents|endoscopic placement of covered biliary stents
16108116|NCT02102984|Device|uncovered biliary stents|endoscopic placement of uncovered biliary stents
16108117|NCT02102971|Procedure|Hepatocellular carcinoma|Participants undergoing a liver resection/liver transplantation surgery. During the liver surgery a small piece of tissue will be removed to undergo additional laboratory testing.
16108118|NCT02102958|Behavioral|DSME with Nonvisual Foot Examination|Diabetes Self-Management Education (DSME) with Nonvisual Foot Examination included comprehensive DSME taught by Certified Diabetes Educators that included instruction in nonvisual self-examination of feet using the senses of touch and smell.
16108119|NCT02102958|Behavioral|DSME with Usual Foot Examination Instruction|DSME with usual foot examination instruction was comprehensive diabetes self management education taught by Certified Diabetes Educators that included usual care instructions for examination for feet at home by visually impaired persons, i.e., to have a sighted person check the feet regularly.
16108120|NCT02102945|Procedure|Computed tomography perfusion|Computed tomography perfusion of the head
16108121|NCT02102932|Drug|5 mg empagliflozin/850 mg metformin FDC|5 mg empagliflozin/850 mg metformin FDC
16108122|NCT02102932|Drug|12.5 mg empagliflozin|10 mg empagliflozin tablet and 2.5 mg empagliflozin tablet
16108123|NCT02102932|Drug|12.5 mg empagliflozin|10mg empagliflozin tablet and 2.5 mg empagliflozin tablet
16108124|NCT02102932|Drug|850 mg metformin|850mg metformin tablet
16108125|NCT02102932|Drug|5 mg empagliflozin|5 mg empagliflozin
16108126|NCT02102932|Drug|5 mg empagliflozin|5 mg empagliflozin
16108127|NCT02102932|Drug|850 mg metformin|850 mg metformin
16108128|NCT02102932|Drug|12.5 mg empagliflozin/850 mg metformin FDC|12.5 mg empagliflozin/850 mg metformin FDC
16108129|NCT02102932|Drug|12.5 mg empagliflozin/500 mg metformin FDC|12.5 mg empagliflozin/500 mg metformin FDC
16108130|NCT02102932|Drug|5 mg empagliflozin/500 mg metformin FDC|5 mg empagliflozin/500 mg metformin FDC
16108131|NCT02102932|Drug|500 mg metformin|500 mg metformin
16108132|NCT02102932|Drug|500 mg metformin|500 mg metformin
16108133|NCT02102919|Device|SR-WBV|Participants will undergo a training program set over eight weeks, three times a week with 3 to 6 Hz, Noise 4.
16108134|NCT02102919|Device|Virtual Games (VG)|Participants will undergo a training program set from week 5 to 8, three times a week over 20 minutes.
16108135|NCT02102919|Other|SR-WBV|Participants will undergo a training program set over eight weeks three times a week with 1 Hz, Noise 1.
16108136|NCT02102919|Device|Aktiv Tramp (Swiss Frei AG, Switzerland)|Participants will undergo a training program set from the 5 to 8 week, three times a week with 1Hz.
16108137|NCT02102906|Procedure|Transcranial magnetic stimulation|Single pulse TMS - 20 pulses at 120% motor threshold. Using the Magstim rapid 2 stimulator, which has a CE mark and will be used within the indications specified by the CE mark.
16108138|NCT02102880|Genetic|the polymerase chain reaction (PCR)|
16108139|NCT02102854|Drug|rATG|Infusion of horse or rabbit-derived antibodies against human T cells, used to prevent & treat acute rejection in organ transplantation
16108140|NCT02102841|Procedure|Skin biopsy|
16108141|NCT02102841|Procedure|Skin suction blister|
16108142|NCT02102841|Biological|Mantoux test|
16108143|NCT02102828|Device|extended compression|Home use of extended compression therapy and aspirin
16108144|NCT02102828|Other|Aspirin|standard therapy of aspirin
16108145|NCT02102815|Drug|Dexamethasone|Dexamethasone 0.15mg/kg mixed with NSS up to 50 mL IV slowly push over 5 minutes
16108146|NCT02102815|Drug|Normal saline|NSS 50 mL IV slowly push over 5 minutes
16108147|NCT02102802|Drug|Full dose MDMA|Participants receiving 125 mg MDMA
16108148|NCT02102789|Drug|mFOLFOX6|Patients will receive mFOLFOX6 every 28 days: Oxaliplatin 85 mg/m2 IV over 3 hours on Day 1, 15; Leucovorin (l-LV) 200mg/m2 IV over 2 hours on Day 1, 15; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion on Day 1, 15.
16108149|NCT02102789|Drug|HAI|"Patients will receive HAI every 28 days: 0.12 mg/kg/day floxuridine (FUDR) and 25 mg dexamethasone in normal saline to a total volume of 300 ml will be administered through the HAI pump.
~This will be repeated on Day 1 of each 28 day cycle. FUDR administration will be a 14-day continuous infusion using the HAI pump."
16108150|NCT02102776|Procedure|MMC|Standardized cotton soaked in mitomycin C (0.02%) will be applied underneath conjunctiva for 5 minutes after pterygium excision.
16108151|NCT02102776|Procedure|AMT|Amniotic membrane transplantation will be applied to cover the conjunctival defect after pterygium excision.
16108152|NCT02102776|Procedure|CAG|A conjunctival autograft, harvested from the superior bulbar conjunctiva of the operating eye, will be applied to cover the conjunctival defect after pterygium excision.
16108153|NCT02102776|Procedure|Pterygium excision|Pterygium head, minimal conjunctiva and anterior tenon's capsule underneath will be removed in the excision of pterygium tissue.
16108154|NCT02102750|Drug|Preservative free tafluprost opthalmic solution|0.0015% eye drops q.d, in both eyes for 7 to 9 days
16108155|NCT02102737|Drug|6-DIG|injection of 6-DIG
16108161|NCT02102685|Procedure|VAC Therapy|within the first three days the VAC therapy was placed , proceeding as follows : Wound cleaning was performed with irrigating solution and replacement of the sponges every 72 hours according to evolution, photographs were taken to assess the percentage of viable tissue and granulation. A Sample to culture was taken prior to placement of VAC therapy , during the use of it and at the time of removal of the system. When the wound presents clinical signs of improvement (elimination of purulent discharge and granulation tissue ) VAC therapy was withdrawn , and follow by delayed primary closure.
16108162|NCT02102685|Procedure|TRADITIONAL THERAPY|after surgical drainage, a culture was taken, photographs every three days (during hospital stay ) and secretion culture; daily cleaning stipulated by the service was perform. The control of the patients were made until wound closure (presence of epithelialization tissue) .
16108163|NCT02102672|Drug|Trimetazidine|
16108164|NCT02102659|Genetic|Upper Limit Nutrition Support Therapy|"Upper limit nutrition support therapy will be used in patens assigned to this group based on the patient's curve of apoptosis of oral mucosal epithelium"
16108165|NCT02102659|Genetic|Formula Nutrition Support Therapy|"Formula nutrition support therapy will be used in patens assigned in this group based on Harris Bendiest Formula."
16108166|NCT02102646|Drug|Triptorelin|Androgen deprivation therapy by Pamorelin 22,5mg/24 weeks administered intramuscularly.
16108167|NCT02102646|Procedure|Orchiectomy|Androgen deprivation therapy by bilateral subcapsular orchiectomy
16108168|NCT02102633|Drug|Dabigatran|Dabigatran 150 mg orally
16108169|NCT02102633|Drug|Bosutinib|Bosutinib 500 mg orally
16108170|NCT02102633|Drug|Dabigatran|Dabigatran 150 mg orally
16108171|NCT02102620|Drug|Intra-articular injection with corticosteroid|After rigorous antisepsis with alcoholic 0.5% chlorhexidine. Sterile insulin syringe BD ™ Ultra Fine needles 8 mm x 0.3 mm 30 G) was used in all patients. The anatomical place used for needle entry was located in the dorsal - lateral joint aspect. After the procedure, the injected joint was immobilized for 48 hours.
16108172|NCT02102620|Drug|Intra-articular injection with lidocaine|After rigorous antisepsis with alcoholic 0.5% chlorhexidine. Sterile insulin syringe BD ™ Ultra Fine needles 8 mm x 0.3 mm 30 G) was used in all patients. The anatomical place used for needle entry was located in the dorsal - lateral joint aspect. After the procedure, the injected joint was immobilized for 48 hours.
16108173|NCT02102607|Other|age|subjects stratified according to age: 20-30 years (Group 1), 31-40 years (Group 2), 41-50 years (Group 3), 51-60 years (Group 4), 61-70 years (Group 5), and 71-80 years (Group 6).
16108174|NCT02102594|Drug|Bortezomib|Bortezomib will be subcutaneously applicated in 2 treatment cycles with 4 injections of 1.3 mg Bortezomib /m2 body surface per cycle.
16108175|NCT02102581|Procedure|short time tourniquet|short time tourniquet: the tourniquet starting from the implantation of prosthesis to the completion of the operation.
16108176|NCT02102555|Drug|IV acetaminophen|Single dose of one gram of IV acetaminophen given in pre-operative area
16108177|NCT02102555|Drug|placebo|placebo (IV normal saline)
16108178|NCT02102529|Procedure|laparoscopic colonic surgery|women with typical symptoms including pelvic pain, infertility and endometriotic bowel lesions who underwent laparoscopic surgery including colonic resection performed from 2009 to 2012
16108179|NCT02102516|Drug|SPRIX(intranasal ketorolac tromethamine)|"Dose: Subjects weighing 3.0 kg received 3.15 mg (1 spray/1 nostril), subjects weighing 5.1 - 10.0 kg received 5.25 mg (1 spray/1 nostril), subjects weighing 10.1 - 15.4 kg received 10.5 mg (1 spray/1 nostril), subjects weighing 15.5 - 31.7 kg received 15.75 mg (1 spray/1 nostril), and subjects weighing >=31.8 kg received 31.5 mg (1 spray/2 nostrils).
~Duration of Treatment: Subjects received a dose of SPRIX every 6 hours from the day of surgery until the morning of post-operative Day 2. Dosing may have resumed after final PK assessment of the morning of post-operative Day 3 until post-operative Day 4. A follow-up phone interview took place 14 days after the final dose of study drug."
16108180|NCT02102503|Behavioral|Standard Treatment|
16108181|NCT02102503|Behavioral|MI and Medication review|
16108182|NCT02102490|Drug|Abemaciclib|Administered orally
16108183|NCT02102477|Procedure|Prostatectomy/Surgery|Radical prostatectomy with or without adjuvant or salvage radiotherapy
16108184|NCT02102477|Other|Radiotherapy with adjuvant androgen deprivation therapy|Radiotherapy with adjuvant androgen deprivation therapy
16108185|NCT02102464|Device|LipiFlow treatment|The LipiFlow® Thermal Pulsation System is a prescription device intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye.
16108186|NCT02102438|Drug|Trastuzumab|"Trastuzumab (at a loading dose of 4mg/kg and a maintenance dose of 2mg/kg) will be given concomitantly with chemotherapy.
~After completion of four chemotherapy cycles, Trastuzumab will be given at a dose of 6mg/kg every 21 days, for a total 14 cycles."
16108187|NCT02102438|Drug|Weekly Paclitaxel|Weekly paclitaxel at 80mg/m2 at D1, D8 and D15 in a 28-day cycle, for a total of 4 treatment cycles.
16108188|NCT02102438|Drug|Carboplatin|Carboplatin at an Area Under the Curve (AUC) of 2 at D1, D8 and D15 in a 28-day cycle, for a total of 4 treatment cycles.
16108189|NCT02102425|Procedure|Patients with or without bandage over exit site|
16108190|NCT02102412|Biological|screening colonoscopy|performance of a colonoscopy with the experimental device followed by complete conventional colonoscopy
16108191|NCT02102399|Behavioral|Vocal Warm-up|Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
16108192|NCT02102399|Behavioral|Respiratory Muscle Training|Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
16108193|NCT02102373|Device|polyethylene glycol 3350|Patients received a polyethylene glycol 3350 solution starting at afternoon the day before the colonoscopy at a dose of 1000 ml/15 kg (maximum 4 L). The patients were instructed to drink all solution in about 4-6 hours.
16108194|NCT02102360|Device|Anorganic Bovine Bone|used to improve periodontal regenerative procedures.
16108195|NCT02102360|Device|Enamel Matrix Derivative|used to improve periodontal regenerative procedures.
16108196|NCT02102347|Other|exercise|
16108197|NCT02102347|Other|Phototherapy|
16108198|NCT02102321|Drug|albendazole|
16108199|NCT02102321|Drug|placebo|
16108202|NCT02102295|Drug|Experimental toothpaste|Experimental toothpaste was containing 0.3% L-ascorbic acid 2-phosphate magnesium salt and 950 ppm fluoride. The registered participants were instructed to brush their teeth twice a day in their customary manner.
16108203|NCT02102295|Drug|Control toothpaste|Control toothpaste was containing 950 ppm fluoride. The registered participants were instructed to brush their teeth twice a day in their customary manner.
16108204|NCT02102269|Device|actimove sling|
16108205|NCT02102269|Device|shoulderlift|
16108206|NCT02102256|Device|Auditory Brainstem Implant|
16108207|NCT02102243|Drug|DEFINITY® infusion|The DEFINITY® vial contains components that upon activation yield perflutren lipid microspheres, a diagnostic drug that is intended to be used for contrast enhancement during echocardiographic procedures. The vial contains a clear, colorless, sterile, non-pyrogenic, hypertonic liquid, which upon activation with agitation, provides a homogeneous, opaque, milky white injectable suspension of perflutren lipid microspheres. The suspension of activated DEFINITY® will be infused intravenously at a rate of 0.20 to 0.27 ml/min, not to exceed a maximum dose of 2 vials per study subject per day or visit.
16108208|NCT02102243|Drug|Human Recombinant Regular Insulin infusion|The plasma insulin concentration will be acutely raised and maintained at at a steady state by a prime-continuous insulin infusion.
16108209|NCT02102243|Drug|Dextrose infusion|The plasma glucose concentration will be held constant at 90 mg/dl by a variable glucose infusion during euglycemic hyperinsulinemic clamp
16108210|NCT02102243|Procedure|Flow mediated vasodilation|Flow mediated vasodilation (FMD), which is a non-invasive assessment of endothelial function, will be performed on the brachial artery using ultrasound. After a clear picture of the artery has been obtained, the cuff on the same arm will be inflated until it is tight for five minutes. During and following this, the subject's arm will continue to be imaged to monitor maximal increase in the brachial artery diameter.
16108211|NCT02102243|Procedure|Endothelial cell collection|We will collect endothelial cells from a superficial vein, usually in the arm. Following insertion of a peripheral intravenous (IV) catheter, we will collect cells from the inner lining of the vein using a thin, flexible J-tipped wire. The wire will be inserted through the IV into the vein and then removed, along with a sampling of endothelial cells. The cells collected will be processed and stained for several proteins involved in endothelial cell function, using immunofluorescent technique.
16108212|NCT02102243|Procedure|Microvascular perfusion assessment using Definity|Using high-resolution ultrasound, we will measure skeletal muscle blood flow during infusion of a solution containing the octafluoropropane microbubble contrast agent, Definity. The solution will be a dilution of 1 vial of Definity to 30 cc of normal saline. The ultrasound probe will be placed over the forearm to obtain images while octafluoropropane microbubbles (Definity) are infused intravenously at the rate of 0.20 to 0.27 ml/min, not to exceed a maximum dose of 2 vials per study subject per day or visit. The microvascular perfusion assessment using Definity be performed at rest as well as during slow and fast handgrip exercises.
16108213|NCT02102243|Procedure|Microneurography|Sympathetic nerve activity from the peroneal nerve measured by inserting a tiny needle directly into the nerve in the leg. Investigators will localize the nerve by electrical stimulation over the skin using a blunt probe. .The recording needle will remain in position throughout the study.
16108214|NCT02102230|Behavioral|Cognitive Behavioral Therapy for Insomnia (CBT-I)|This is a group-delivered version of the six-session Cognitive-Behavioral Treatment for Insomnia that has been disseminated throughout the VA. It incorporates psychoeducation, diary-based sleep assessment, estimation of sleep scheduling and efficiency, evaluation/mitigation of dysfunctional sleep-related beliefs/ behaviors, generation of sleep prescription (typically restriction), iterative review of sleep efficiency and prescription, and planning for maintenance of gains.
16108215|NCT02102230|Behavioral|Cognitive Behavioral Therapy for Insomnia Plus Mobile App (CBT-I-MA)|This is a mobile-app-augmented, group-delivered version of the six-session Cognitive-Behavioral Treatment for Insomnia that has been disseminated throughout the VA. It incorporates psychoeducation, diary-based sleep assessment, estimation of sleep scheduling and efficiency, evaluation/mitigation of dysfunctional sleep-related beliefs/ behaviors, generation of sleep prescription (typically restriction), iterative review of sleep efficiency and prescription, and planning for maintenance of gains. The mobile-app augmentation substitutes a smartphone-based sleep diary with time-stamping of records to mitigate the common postponement of diary recording and consequent loss of validity. The app also records the sleep prescription, making it, along with links to web-based psychoeducational materials, easily accessible to users. The app also provides plots of bed times, wake times, and sleep efficiency over time, with the goal of promoting adherence.
16108216|NCT02102230|Behavioral|Desensitization Treatment for Insomnia|"This is a group-delivered version of the sham sleep improvement treatment developed by Edinger which purports to desensitize the patient to the various aspects of the sleep experience which are presented as distressing."
16108217|NCT02102217|Procedure|PRECious|Standardized measurement of serum CRP levels on postoperative day 3,4 and 5.
16108218|NCT02102204|Drug|Etelcalcetide|Etelcalcetide was supplied as a sterile, preservative-free, ready-to-administer aqueous solution.
16108219|NCT02102191|Device|e-cigarette|smoking cigarette without tobacco
16108220|NCT02102191|Device|cigarette|smoking cigarette with tobacco
16108221|NCT02102178|Other|Tapestry|"A gauze screen, wool thread appropriate for tapestry and a large needle were used.
~The entire screen was filled with a striped pattern made of embroidered half-stitches in the individuals' preferred colors. To fill the screen with half-stitches, the needle was always worked in diagonal movements, point to point. The stitches were started keeping a distance of three points from the four edges."
16108222|NCT02102178|Other|Regular occupation therapy|All the patients were followed up daily for 10 days by a single occupational therapist for around 30 minutes, during which they received guidance regarding how best to perform their ADLs, i.e. how to position themselves when sitting down and standing up, dressing and undressing, feeding themselves, performing personal hygiene and undertaking leisure activities, with the aim of protecting their joints, reducing the pain and expending less energy.
16108264|NCT02101892|Drug|placebo|per os, daily, evening
16108265|NCT02101866|Drug|Vapendavir 300 mg tablet|tablet - single dose
16108266|NCT02101866|Drug|Vapendavir 132 mg capsules|2 capsules - single dose
16108267|NCT02101853|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic HSCT
16108268|NCT02101853|Drug|Asparaginase|Given IM or IV
16108223|NCT02102178|Other|Weaving a scarf on a nail frame|"Weaving a scarf on a nail frame: this activity used a rectangular wooden frame (30 cm x 10 cm), with an empty space in the middle and nails distributed at 1 cm intervals along all sides, together with a crochet needle and wool thread.
~Procedure: The thread was measured out on the frame and all the fringes were cut to the same length. After this, each thread was knotted, leaving a loop that was placed over each nail. A wool thread was tied to the nail at the corner and a zigzag pattern was woven between alternate nails. On the return, the zigzag weave went via the nails that had initially been missed out. Using the crochet needle, the loop of the fringe was pulled across on top of the zigzag. The scarf went on coming out from under the frame. The zigzag sequence and the needle movement were repeated until the scarf reached the desired length."
16108224|NCT02102178|Other|Domino game|"Each player received seven dominos and kept them concealed from the adversaries' eyes. The player with the double-six (domino with the number six at both ends) started the game. If this domino had not been dealt out to any player, the one with the highest double domino started. Following on from this first player, in clockwise direction, each subsequent player placed one domino at one of the ends of the chain that was formed as the dominos were played. If a player did not have a domino that could be played, he would go to the pile and keep on picking up dominos until getting one that would fit. If no such domino existed, the player would then pass his turn on to the next player. The first player to get rid of all his dominos was the winner. If the game became blocked, i.e. there was no longer any possibility of adding dominos to the chain, the points in each player's hand were counted and the winner was the one with the lowest number of points in his hand."
16108225|NCT02102165|Procedure|metastatic lesion biopsy|a medical test commonly performed by a surgeon or an interventional radiologist in order to collect tissues for examination; in this case from a metastatic lesion
16108226|NCT02102152|Drug|Tobramycin|
16108227|NCT02102139|Drug|DXM + Propofol|"After induction as mentioned at 'arm description', the effect-site propofol concentration was fixed at 5.0 μg mL-1 at the time of diluted epinephrine injection and was unchanged during the entire hydrodissection period in all patients.
~The first patients received effect-site concentrations of remifentanil of 4 ng mL -1, respectively. The EC50 of remifentanil for stable hydrodissection was determined by a modification of Dixon's up-and-down method.If the response was success (SBP during the entire hydrodissection period being ±20% from baseline), the next target concentration of remifentanil was decreased by a step of 0.5 ng mL -1. If the response was fail(SBP > ±20% from baseline), the target concentration was increased by 0.5 ng mL-1."
16108228|NCT02102139|Drug|Saline + Propofol|All procedure would be same in DXM+Propofol group except saline loading rather than DXM loading before induction.
16108229|NCT02102126|Procedure|Renal denervation|
16108230|NCT02102113|Drug|Placebo|placebo
16108231|NCT02102113|Drug|Very Low Dose THC|Subjects will receive 0.010mg/kg.
16108232|NCT02102113|Drug|Low Dose THC|Subjects will receive 0.018 mg/kg over 20 minutes.
16108233|NCT02102100|Drug|nicotine|In each of 3 test sessions, subjects in each arm will receive a randomized sequence of three intravenous infusions (30 sec each), one hour apart. The infusions will consist of saline, nicotine (.25 mg / 70kg) and nicotine (0.5 mg / 70 kg). The randomized sequence will remain the same between test sessions for a given subject.
16108234|NCT02102100|Drug|menthol|In each of 3 test sessions, subjects will take 6 inhalations from the study e-cigarette, one inhalation every 15 seconds, of the randomized menthol condition for that test session ust prior to each intravenous infusion. The menthol conditions are: 3.2% menthol, 0.5% menthol and tobacco-flavor only (0.0% menthol)
16108235|NCT02102087|Device|Initial Specimen Diversion Device (ISDD)|
16108236|NCT02102087|Device|Lab standard practice (LSP)|
16108237|NCT02102061|Other|multidisciplinary intervention|"a health- and quality of life-oriented program comprising exercise, nutrition advices, and philosophy meetings, without a focus on weight loss, following the philosophical principles from Health at Every Size."
16108238|NCT02102048|Drug|Atazanavir|
16108239|NCT02102035|Procedure|Direct and reversed dorsal digital island flap|The direct dorsal digital island flap is used to cover the defects of adjacent fingers. The reversed dorsal digital island flap is used to cover the defects of the same fingers.
16108240|NCT02102022|Drug|ADI-PEG 20 plus modified FOLFOX6|
16108241|NCT02102009|Dietary Supplement|Complete enteral formula|"Product: Complete nutritional formula in powder enriched with key nutrients to be administered orally (200 ml of water per 57 g product).
~Time of intervention: 3 months."
16108242|NCT02102009|Other|Dietary Advise|Patients will receive the usual dietary advise in these patients according hospital clinical practice .
16108243|NCT02101996|Other|high-fat diet|Subjects consume a high-fat diet for three weeks before the in-hospital stay.
16108244|NCT02101983|Drug|Cytosine Arabinoside|
16108245|NCT02101970|Dietary Supplement|Omega-3 Fatty Acids|Amber 4020 Ethyl Ester (EE) 1000 mg omega-3 capsule contains 420 mg of EPA and 210 mg of DHA both as the ethyl esters (380 mg EPA and 190 mg DHA)
16108246|NCT02101970|Other|Placebo Capsule|
16108247|NCT02101970|Other|Diet and Exercise|Increasing physical activity required over 6 month period to be tracked by a Fitbit. Diet based on caloric intake and eating approved foods.
16108248|NCT02101957|Drug|RP103|
16108249|NCT02101957|Drug|Placebo|
16108250|NCT02101944|Drug|Carfilzomib|Given IV
16108251|NCT02101944|Drug|Dexamethasone|Given IV
16108252|NCT02101944|Other|Laboratory Biomarker Analysis|Correlative studies
16108253|NCT02101944|Biological|Pelareorep|Given IV
16108254|NCT02101931|Drug|Amino levulinic Acid|The bladder cancer patients is required to swallow a chemical called Amino levulinic Acid, about 10mg/kg body weight. 5ml of blood and one urine samples will be taken before using Amino levulinic Acid. The patient must drink water then the urine will be collected after 4, 8 and 12 hours of taking ALA and the samples will be analyzed by photodynamic diagnostic procedure. ALA gets metabolized into certain types of porphyrins which selectively bind on to the tumor tissues (for a longer time than the normal tissues).
16108255|NCT02101918|Radiation|Computed Tomography Perfusion Imaging|Undergo computed tomography perfusion imaging
16108256|NCT02101918|Other|Laboratory Biomarker Analysis|Correlative studies
16108257|NCT02101918|Biological|Ziv-Aflibercept|Given IV
16108271|NCT02101853|Drug|Cytarabine|Given IT and IV or SC
16108272|NCT02101853|Drug|Dexamethasone|Given PO or IV
16108273|NCT02101853|Drug|Etoposide|Given IV
16108274|NCT02101853|Other|Laboratory Biomarker Analysis|Correlative studies
16108275|NCT02101853|Drug|Leucovorin Calcium|Given IV or PO
16108276|NCT02101853|Drug|Mercaptopurine|Given PO
16108277|NCT02101853|Drug|Methotrexate|Given IT, IV, and PO
16108278|NCT02101853|Drug|Mitoxantrone|Given IV
16108279|NCT02101853|Drug|Mitoxantrone Hydrochloride|Given IV
16108280|NCT02101853|Drug|Pegaspargase|Given IV
16108281|NCT02101853|Other|Pharmacological Study|Correlative studies
16108282|NCT02101853|Radiation|Radiation Therapy|Undergo cranial radiation therapy
16108283|NCT02101853|Drug|Therapeutic Hydrocortisone|Given IT
16108284|NCT02101853|Drug|Thioguanine|Given PO
16108285|NCT02101853|Drug|Vincristine|Given IV
16108286|NCT02101853|Drug|Vincristine Sulfate|Given IV
16108287|NCT02101840|Drug|Apo-Oxycodone CR®|a single 40mg oral dose of the controlled release oxycodone formulation Apo-Oxycodone CR®
16108288|NCT02101840|Drug|OxyNEO®|a single 40mg oral dose of the controlled release oxycodone formulation OxyNEO®
16108289|NCT02101840|Drug|Placebo|a single oral dose of placebo prepared using gelatin capsules and lactose filler with identical looking study capsules as the oxycodone products
16108290|NCT02101814|Procedure|Roux-en-Y gastric bypass (bariatric surgery)|
16108291|NCT02101801|Other|vegetables from fresh or recycled water|
16108292|NCT02101801|Other|receives vegetables from fresh water or recycled waste water farms|
16108293|NCT02101788|Drug|Letrozole|Given PO
16108294|NCT02101788|Drug|Paclitaxel|Given IV
16108295|NCT02101788|Drug|Pegylated Liposomal Doxorubicin Hydrochloride|Given IV
16108296|NCT02101788|Other|Quality-of-Life Assessment|Ancillary studies
16108297|NCT02101788|Other|Questionnaire Administration|Ancillary studies
16108298|NCT02101788|Drug|Tamoxifen Citrate|Given PO
16108299|NCT02101788|Drug|Topotecan|Given IV
16108300|NCT02101788|Drug|Trametinib Dimethyl Sulfoxide|Given PO
16108301|NCT02101775|Drug|Adavosertib|Given PO
16108302|NCT02101775|Drug|Gemcitabine Hydrochloride|Given IV
16108303|NCT02101775|Other|Laboratory Biomarker Analysis|Correlative studies
16108304|NCT02101775|Other|Pharmacological Study|Correlative studies
16108305|NCT02101775|Other|Placebo Administration|Given PO
16108306|NCT02101775|Other|Questionnaire Administration|Ancillary studies
16108307|NCT02101749|Biological|trivalent inactivated influenza|intradermal or intramuscular injection in the deltoid area.
16108308|NCT02101736|Drug|Cabozantinib|This is an open label Phase II clinical trial. For both cohorts, subjects will receive cabozantinib orally in continuous cycles. Each cycle is 28 days. In absence of progressive disease or dose limiting toxicity (DLT), subjects may continue therapy for a total of 12 cycles. Subjects with radiographic response (20% or greater reduction in tumor volume) at the end of 12 cycles can continue on therapy for up to an additional year. However, subjects who do not achieve 15% reduction in tumor volume after 8 cycles will be considered treatment failure and taken off study. Subjects will be carefully monitored for toxicities associated with cabozantinib.
16108309|NCT02101723|Dietary Supplement|MNP + Zn/Fe|Micronutrient powder with 12 mg Fe and 5 mg Zn provided daily from 6-9 months of age
16108310|NCT02101723|Dietary Supplement|MNP + Zn|Micronutrient powder with 5 mg Zn provided daily from 6-9 months of age
16108311|NCT02101723|Dietary Supplement|Placebo|Placebo powder without micronutrients
16108312|NCT02101710|Drug|Elantan SR 60 mg|"Trade Name: Elantan
~Active Substance: Isosorbide 5-mononitrate
~Pharmaceutical form: Tablet
~Concentration: 60 mg
~Route of Administration: Oral administration"
16108313|NCT02101710|Drug|Imdur SR 60 mg|"Trade Name: Elantan
~Active Substance: Isosorbide 5-mononitrate
~Pharmaceutical form: Tablet
~Concentration: 60 mg
~Route of Administration: Oral administration"
16108314|NCT02101697|Behavioral|HIV Stigma Reduction Intervention|"The HIV stigma reduction intervention consists of two computer-administered sessions and one group session.
~Session 1. (approx. 60 min). Introduction of the concepts of stigma and discrimination, vulnerable populations and symbolic stigma delivered in an interactive tablet format, using games and videos.
~Session 2. (approx. 60 min). Interactive activities to address HIV transmission myths and misconceptions and the importance of universal precautions.
~Session 3. (approx 90 min). Patient interaction skills. In person interactive group session co-facilitated by PLHIV and staff focusing on skills building through role-plays and feedback.
~Our previous research has found that these modules address factors identified as contributing to health professionals' stigma."
16108315|NCT02101684|Drug|Orteronel 300mg BID|
16108316|NCT02101658|Other|clinic-based weight measurements|
16108317|NCT02101645|Procedure|Periodical low intensity direct current (LIDC) stimulation of wound.|Wound is stimulated using LIDC current. Stimulation current magnitude is in micro-ampere range. Stimulation sequence is 1 hour on and 1 hour off for 72 hours or 96 hours.
16108318|NCT02101645|Procedure|Compression therapy of swollen limbs.|Compression bandage is used for reducing swelling of the limbs.
16108319|NCT02101632|Dietary Supplement|Bee Venom Ointment|2 weeks
16108320|NCT02101632|Other|Vaseline Ointment|2 weeks
16108321|NCT02101606|Drug|Tenecteplase (TNK) (0.25 mg/kg, to maximum of 25mg)|TNK will be administered within 30 minutes once MRI and CTP inclusion criteria are determined to have been met.
16108322|NCT02101593|Drug|ADI-PEG 20|
16108323|NCT02101580|Drug|ADI-PEG 20|
16108324|NCT02101567|Drug|Pabal 100 mcg iv infusion over 1 minute given after delivery of fetal head|In the first group of patients, carbitocin 100 mcg will be given iv infusion over one minute after delivery of the head in cesarean section.
16108325|NCT02101567|Drug|Oxytocin 5 IU iv infusion and Methtergine 0.2 mg iv|In the second group of patients oxytocin 5 IU will be given iv infusion and Methergine 0.2 mg iv
16108326|NCT02101554|Drug|Ages 7-11|Oral/Capsule, once per day or twice per day dosing; Treatment duration consists of a 1 to 4 week Conversion/Titration Phase leading to a 2 to 6 week Maintenance Treatment duration.
16108327|NCT02101554|Drug|ages 12-17|Oral/Capsule, once per day or twice per day dosing; Treatment duration consists of a 1 to 4 week Conversion/Titration Phase leading to a 2 to 6 week Maintenance Treatment duration.
16108328|NCT02101541|Procedure|FIRM ablation|Radiofrequency catheter ablation of atrial fibrillation driving sources detected by sequential bi-atrial panoramic contact mapping.
16108329|NCT02101515|Other|Length of Second Stage|The experimental group will have one additional hour in the second stage of labor
16108330|NCT02101502|Other|Questioner|Obstetrics and gynecology health problems questionnaire for patients Educational effectiveness special questionnaire for medical staffs Institutional capacity special questionnaire for institution employees
16108331|NCT02101489|Other|Foley Catheter|20 with intraoperative Foley catheter measurement of the urethral length and 20 without
16108332|NCT02101476|Drug|Percocet|10mg/650mg
16108333|NCT02101476|Drug|Xartemis|15mg/650mg
16108334|NCT02101463|Device|surgeon-modified fenestrated-branched stent-grafts (sm-FBSG)|
16108335|NCT02101450|Procedure|Extra-abdominal removal of the placenta|The uterus will be dragged out of the abdominal cavity, prior to removal of the placenta.
16108336|NCT02101450|Procedure|Extra-abdominal removal of the placenta|The placenta will be manually removed extra-abdominally, with uterine massage as soon as possible.
16108337|NCT02101450|Procedure|Extra-abdominal removal of the placenta|The cesarean incision will be sutured with no. 1 Vicryl ®.
16108338|NCT02101450|Procedure|Extra-abdominal removal of the placenta|Uterus will be replaced in the abdominal cavity.
16108339|NCT02101437|Procedure|miRNA within 24hr|miRNA within 24hr
16108340|NCT02101437|Procedure|miRNA after 1 week|miRNA after 1 week
16108341|NCT02101437|Procedure|miRNA after 1 month|miRNA after 1 month
16108342|NCT02101411|Diagnostic Test|PRU(Platelet reactivity unit)|measure by VeryfyNow.
16108343|NCT02101398|Device|eldith DC-stimulator, configuration F7A|tDCS will be delivered during a 20 minutes speech-language therapy session
16108344|NCT02101398|Device|eldith DC-stimulator, configuration F7C|tDCS will be delivered during a 20 minutes speech-language therapy session
16108345|NCT02101398|Device|eldith DC-stimulator, configuration T5A|tDCS will be delivered during a 20 minutes speech-language therapy session
16108346|NCT02101398|Device|eldith DC-stimulator, configuration T5C|tDCS will be delivered during a 20 minutes speech-language therapy session
16108347|NCT02101398|Device|eldith DC-stimulator, configuration Sham|Sham tDCS will be delivered during a 20 minutes speech-language therapy session
16108348|NCT02101385|Drug|Genomically Directed Monotherapy|Participants randomized to Experimental Arm A will receive an FDA approved drug at standard dose for four cycles (12-16 weeks total duration, depending on cycle length). The CGTB will assign therapy to each participant individually based on biomarkers/pathways identified by DNA sequencing:
16108349|NCT02101385|Other|Observation/Standard Therapy|Currently no standard therapy has proven efficacy in this patient population and thus observation alone would be considered standard of care. Additional therapy is permitted, however, if deemed appropriate by the treating physician.
16108350|NCT02101372|Behavioral|treatment as usual|case management
16108351|NCT02101372|Behavioral|Psychoeducation group treatment|Psychoeducation therapy problem solving focus
16108352|NCT02101359|Drug|T2380|200 microlitres of T2380 will be administrated intracamerally
16108353|NCT02101359|Drug|Mydriatics|3 drops of tropicamide and phenylephrine were instilled 30 minutes before surgery. The second and the third instillation of both phenylephrine and tropicamide will be realised respectively within 20 and 10 minutes before surgery.
16108354|NCT02101359|Drug|Tetracaine|Two drops of tetracaine were instilled in the eye to be operated 5 minutes and 1 minute before surgery
16108355|NCT02101346|Dietary Supplement|Mixed High Fat Diet|Healthy, Round 1
16108356|NCT02101346|Dietary Supplement|Saturated fat diet|Healthy, Round 1 Healthy, Round 2
16108357|NCT02101346|Dietary Supplement|Monounsaturated fat diet|Healthy, Round 1
16108358|NCT02101346|Dietary Supplement|Polyunsaturated fat diet|Healthy, Round 1
16108359|NCT02101346|Dietary Supplement|Triolein 13C|Healthy, Round 2
16108360|NCT02101346|Dietary Supplement|Low fat|Healthy, Round 1
16108361|NCT02101333|Drug|Tocilizumab|intravenous injection 8 mg/kg, monthly during 6 months
16108362|NCT02101320|Device|TRECAM|using the camera during the surgery
16108363|NCT02101294|Device|Interossei Lumbricals Neuro Interface|Finger Relief's keyboard home row layout [actual home row placement order: asdeihotlrn], plus substitutions on the upper row [qwfgjyuk;p] and bottom row [zxcvb'm,.] moves or shifts finger and thumb movement from the elbow muscles to the finger muscles. The movement of finger bending toward the palm is shifted to the interosseous and lumbrical muscles of the hand and fingers from the full flexion and extension muscle control to reduce contraction and expansion of tendons and the movement in the carpal canal adjacent to the median nerve and reduces pressure on the median nerve. Pressure on the median nerve compromises the nerve leading to symptoms of the carpal tunnel syndrome of pain, tingling, and numbness.
16108364|NCT02101294|Device|Standard QWERTY keyboard|Report of onset and severity symptoms of carpal tunnel syndrome when typing with QWERTY keyboard and the Finger Relief device.
16108365|NCT02101281|Drug|rhNGF 20 µg/mL|1 drop for each eye, twice daily for 28 day
16108366|NCT02101281|Drug|rhNGF 4 µg/mL|1 drop each eye, twice daily for 28 day
16108367|NCT02101268|Drug|Momelotinib|Momelotinib tablet administered orally once daily
16108368|NCT02101268|Drug|Best Available Therapy (BAT)|Regimens for BAT may include but are not limited to chemotherapy (eg hydroxyurea), anagrelide, corticosteroid, hematopoietic growth factor, immunomodulating agent, androgen, interferon, and may include no myelofibrosis treatment.
16108369|NCT02101255|Device|Curodont Repair|"Self-assembling peptide, biomimetic re-mineralisation
~Application on Day 0 and Day 360"
16108370|NCT02101255|Device|Fluoride|Application on Day 0, Day 180, Day 360, Day 540
16108371|NCT02101229|Drug|Insulin, Asp(B28)-|"the insulin dose is calculated by the Diabeloop algorithm and then administered to the patient"
16108372|NCT02101216|Drug|Prurisol|Experimental Drug
16108373|NCT02101216|Drug|Ziagen|Active comparator
16108374|NCT02101203|Drug|Placebo|
16108375|NCT02101203|Drug|0.5 mgTestosterone + 10 mg Buspirone|"A total of 28 doses will be provided. Subjects are required to take a minimum of 8 doses over the 8-week treatment period (1 dose/week). The other 20 doses may be taken as desired (ie, on demand) throughout the 8-week treatment period; dosing is permitted every 2 days (ie, on alternate days)."
16108376|NCT02101190|Drug|BIA 9-1067|Opicapone, OPC
16108377|NCT02101164|Biological|denosumab|Treatment Group A - 120 mg SC dose every 4 weeks at Day 1 and week 5 Treatment Group B - 120 mg SC dose every 4 weeks at Week 9 and Week 13
16108378|NCT02101164|Drug|pamidronate|Treatment Group A - 90 mg IV dose every 4 weeks at Week 9 and Week 13 Treatment Group B - 90 mg IV dose every 4 weeks at Day 1 and Week 5
16108379|NCT02101151|Dietary Supplement|Vitamin D3(cholecalciferol)|
16108380|NCT02101138|Drug|Dexpramipexole|Dexpramipexole (KNS 760704) is a synthetic amino-benzothiazole developed for use in amyotrophic lateral sclerosis (ALS)
16108381|NCT02101125|Drug|BMS-986020|
16108382|NCT02101125|Drug|Rosuvastatin|
16108383|NCT02101112|Drug|Apixaban|
16108384|NCT02101099|Device|Colonoscopy Force Monitor|Use of Colonoscopy Force Monitoring device (CFM) to measure forces applied to the colonoscope during the procedure.
16108385|NCT02101086|Other|Blood transfusion|Whenever the infant indicated to receive transfusion, a blood product request was sent to the blood bank. This infant was randomly assigned to the autologous or the allogeneic product labeled for each patient at birth in the blood bank
16108386|NCT02101073|Biological|ALX-0061|single dose, intravenous
16108387|NCT02101073|Biological|ALX-0061|single dose, subcutaneous
16108388|NCT02101060|Other|exercise|16-week progressive aerobic and resistance exercise training
16108389|NCT02101047|Drug|Phenylephrine|
16108390|NCT02101034|Biological|Cetuximab|
16108391|NCT02101034|Drug|PD 0332991|
16108392|NCT02101021|Drug|Momelotinib|Tablet (s) administered orally once or twice daily
16108393|NCT02101021|Drug|Placebo to match momelotinib|Placebo to match momelotinib tablets administered orally once or twice daily
16108394|NCT02101021|Drug|Nab-paclitaxel|Intravenously administered over approximately 30-40 minutes or as per institutional standard of care on Days 1, 8, and 15 of each cycle
16108395|NCT02101021|Drug|Gemcitabine|Intravenously administered over approximately 30 minutes or as per institutional standard of care on Days 1, 8, and 15 of each cycle
16108396|NCT02101008|Drug|disulfiram and chelated zinc|
16108397|NCT02100995|Behavioral|Intervention Simultaneously Targeting Obesity and Pain|
16108398|NCT02100995|Behavioral|Weight Loss/Weight Self-Management|
16108399|NCT02100995|Behavioral|Chronic Pain Self-Management|
16108400|NCT02100982|Other|Customized Care|Customized Care consists of two components. The first component is a Discussion Prioritization Tool (DPT) which forces patients to make trade-offs between competing concerns to help them determine which are the most important to discuss. The second component is a customized question prompt list (QPL) to help patients communicate their priorities to the PCP. The QPL will be generated after patients use the DPT, and consists of question prompts tailored to the patients' priorities. Consented patient-participants will be told that the subsequent office visit with the PCP will be audio-recorded to assess patient-PCP communication.
16108401|NCT02100982|Other|Care As Usual|Participants in this condition will interact with the research staff who will help the participant use an iPad in the waiting room to complete baseline health assessments. Consented patient-participants will be told that the subsequent office visit with the PCP will be audio-recorded to assess patient-PCP communication.
16108402|NCT02100969|Drug|HIZENTRA ®|Patients must fulfill inclusion criteria and remain stable at week 0, which means QMG does not increase by 3 points, will enter receive Hizentra for 12 weeks.
16108403|NCT02100956|Drug|oxytocin 100 micrograms|oxytocin 100 micrograms administered intrathecally (IT)
16108404|NCT02100956|Drug|Normal Saline (preservative free)|Normal Saline (preservative free) administered intrathecally (IT)
16108405|NCT02100930|Biological|Anti-GD2 3F8 Monoclonal Antibody|
16108406|NCT02100930|Drug|GM-CSF (granulocyte-macrophage colony-stimulating factor)|
16108407|NCT02100930|Drug|oral isotretinoin|
16108408|NCT02100917|Drug|DMB-3111|
16108409|NCT02100917|Drug|trastuzumab|
16108410|NCT02100904|Procedure|Radiofrequency ablation of fibroids|
16108411|NCT02100904|Procedure|Myomectomy of fibroids|
16108412|NCT02100891|Procedure|Allogeneic HCT|Patients will undergo HLA-haploidentical bone marrow transplant preceded by reduced-intensity chemotherapy and radiation therapy, followed by donor NK cells on day +7 after transplant.
16108413|NCT02100891|Drug|Donor NK Cell Infusion|Patients will undergo HLA-haploidentical bone marrow transplant preceded by reduced-intensity chemotherapy and radiation therapy, followed by donor NK cells on day +7 after transplant.
16108414|NCT02100865|Device|Solar powered oxygen|
16108415|NCT02100865|Device|Oxygen from cylinders|
16108416|NCT02100852|Drug|TGR-1202 + Obinutuzumab + Chlorambucil|TGR-1202: Oral dose Obinutuzumab: IV infusion Chlorambucil: Oral dose
16108417|NCT02100839|Drug|AEM-28|Solution for injection
16108418|NCT02100839|Drug|Normal Saline|0.9% saline for injection
16108419|NCT02100826|Drug|Cephalexin|Administered orally.
16108420|NCT02100813|Drug|LEO 43204|
16108421|NCT02100813|Drug|Placebo|
16108422|NCT02100800|Other|MR and CT measurements of emphysema quantification|
16108423|NCT02100787|Other|TheraTears lubricating drops|A over-the-counter lubricating eye drop to be used 1 drop in both eyes 4 times a day (QID) for 8 weeks
16108424|NCT02100761|Drug|Voriconazole|Patients with creatinine clearance at least 50 ml/min will be treated with voriconazole by intravenous drip infusion at the dose of 6 mg/kg twice daily on the first day (Day 1) and 4 mg/kg twice daily from day 2 onward. The IV treatment is at least 7 days. Then switch to 200 mg orally twice daily between meals. The total treatment duration is at least 14 days Patients with creatinine clearance <50 ml/min will be treated with oral voriconazole (loading dose of 400 mg twice daily followed by maintenance dose of 200 mg twice daily between meals for at least 14.0 days).
16108425|NCT02100748|Drug|TRV130|TRV130 1 - 4 mg will be administered every 4 hours
16108426|NCT02100748|Drug|Morphine|Morphine 4 mg will be administered every 4 hours
16108427|NCT02100748|Drug|Placebo|Placebo will be administered every 4 hours
16108428|NCT02100735|Other|Sedation protocol|Nursing driven sedation protocol
16108429|NCT02100722|Procedure|FFR guided PCI|
16108430|NCT02100722|Procedure|CABG|
16108431|NCT02100709|Device|BiLevel Noninvasive Ventilation|Positive pressure applied through an oro-nasal mask. The pressure is altered between inspiration and expiration.
16108719|NCT02098785|Drug|Caffeine citrate|Oral solution
16108432|NCT02100696|Drug|Etrozulimab|Participants will receive 105 mg etrolizumab administered by SC injection Q4W.
16108433|NCT02100696|Drug|Placebo|Participants will receive placebo (matched with etrolizumab) administered by SC injection Q4W.
16108434|NCT02100683|Device|PDA Coil|The Nit-Occlud PDA is a permanently implanted prosthesis indicated for percutaneous, transcatheter closure of small to moderate size patent ductus arteriosus with a minimum angiographic diameter < 4 mm.
16108435|NCT02100670|Drug|1% diclofenac sodium plus 3% menthol|To be applied four times daily for 10 days.
16108436|NCT02100670|Drug|1% diclofenac sodium plus 0.09% menthol|To be applied four times daily for 10 days.
16108437|NCT02100670|Drug|3% menthol|To be applied four times daily for 10 days.
16108438|NCT02100670|Drug|Placebo with 0.09% menthol gel|To be applied four times daily for 10 days.
16108439|NCT02100657|Drug|Plitidepsin|
16108440|NCT02100657|Drug|Bortezomib|
16108441|NCT02100657|Drug|Dexamethasone|
16108442|NCT02100644|Drug|Lamotrigine tablets 25/100 mg|Lamotrigine (LTG) is administered according to the package insert: that is, 25 mg of LTG will be orally administered once every other day for the first 2 weeks and then once daily for the next 2 weeks. Thereafter, the dose will be gradually escalated by 25-50 mg every 1-2 week for once or twice daily administration. During the VPA reduction phase and LTG&amp;VPA maintenance phase, as specified in the information of package insert, maintenance dose of LTG will be administered twice daily.
16108443|NCT02100631|Biological|PXVX0200|
16108444|NCT02100631|Biological|Placebo|
16108445|NCT02100618|Procedure|Blood sampling|Blood samples will be collected from all subjects at Year 6.5
16108446|NCT02100605|Device|Phytosun, decongestant, nasal spray|one time application of the nasal spray
16108447|NCT02100592|Other|Early rehabilitation treatment on Erigo Hocoma|5 weekly sessions of erigo for three weeks. Expected tilt angle up to 60 °
16108448|NCT02100592|Other|Early rehabilitation treatment on Erigo Hocoma|Early verticalization treatment with Erigo Hocoma, a tilt table with stepping system
16108449|NCT02100579|Drug|Bupivacaine|10 ml of 0.25% bupivacaine
16108450|NCT02100579|Drug|Preservative free normal saline|10 ml of preservative free normal saline
16108451|NCT02100566|Behavioral|Counseling (Care giver burden focus)|An advance directive (AD) document is provided to the patient along with counseling that focuses on care giver burden as the reason for adoption of the AD.
16108452|NCT02100566|Behavioral|Counseling (patient autonomy focus)|An advance directive (AD) document is provided to the patient along with counseling that focuses on patient autonomy (control) as the reason for adoption of the AD.
16108453|NCT02100553|Drug|CE/BZA|CE 0.45mg/BZA 20mg tablets, single dose
16108454|NCT02100553|Drug|Itraconazole|Two 100 mg capsules, once daily for 7 days
16108455|NCT02100553|Drug|CE/BZA|CE 0.45mg/BZA 20mg tablets, single dose on Day 5
16108456|NCT02100553|Drug|CE/BZA|CE 0.45mg/BZA 20mg tablets, single dose
16108457|NCT02100553|Drug|Itraconazole|Two 100 mg capsules, once daily for 7 days
16108458|NCT02100553|Drug|CE/BZA|CE 0.45mg/BZA 20mg tablets, single dose on Day 5
16108459|NCT02100540|Drug|I placebo capsule|I placebo capsule
16108460|NCT02100540|Drug|II RDC 0.3mg capsule|II RDC 0.3mg capsule
16108461|NCT02100540|Drug|III RDC 0.6mg capsule|III RDC 0.6mg capsule
16108462|NCT02100527|Drug|PF-05175157|200 mg (as 2x100 mg tablets) twice a day (BID) for 6 weeks
16108463|NCT02100527|Drug|Placebo|placebo matching 200 mg (as 2x100 mg tablets) BID for 6 weeks
16108464|NCT02100514|Drug|Bococizumab (PF-04950615; RN316)|150 mg every 2 weeks, subcutaneous injection for 52 weeks.
16108465|NCT02100514|Other|Placebo|Subcutaneous injection every 2 weeks for 52 weeks.
16108466|NCT02100488|Device|Closed-loop insulin infusion system|"Each subject will undergo two Open-loop and two Closed-loop meal tests, each one at 1-2 week intervals, thus completing the 4 experiments in about 6 weeks. The day of the experiment, a standard mixed meal test containing 60 g of carbohydrates (CHO), will be administered. On two occasions, patients will receive in a randomized order the standard insulin bolus based on the individual insulin to CHO ratio (First arm, Open-loop study). On the other two occasions they will receive a Sliding Mode Reference Conditioning (SMRC) Closed-loop insulin administration, based on subcutaneous continuous glucose monitoring (Second arm, Closed-loop study). Commercial insulin infusion systems and continuous glucose monitoring devices will be used."
16108467|NCT02100488|Other|Open-loop insulin infusion system|Standard subcutaneous insulin infusion based on the individual insulin to carbohydrate ratio. Commercial insulin infusion systems and continuous glucose monitoring devices will be used.
16108468|NCT02100475|Drug|insulin degludec/liraglutide|"Insulin degludec/liraglutide will be given subcutaneously (s.c., under the skin) once daily in combination with metformin.
~Dose individually adjusted."
16108469|NCT02100475|Drug|insulin aspart|Dose titration of insulin aspart will be based on the respective pre-meal(s) and bedtime SMPG measured daily.
16108470|NCT02100462|Drug|Chlorthalidone 12.5 mg|
16108471|NCT02100462|Drug|Hydrochlorothiazide 25 mg|
16108472|NCT02100462|Drug|Aspirin 81 mg|
16108473|NCT02100449|Other|Lung ultrasound and Doppler (Day 0)|In patients presenting a consolidation of suspected atelectatic nature, a lung ultrasound examination using pulsed-wave Doppler will be performed on Day 0 only.
16108474|NCT02100449|Other|Lung ultrasound and Doppler (Day 0 and Day 3 to 5)|In patients presenting a consolidation of suspected infectious nature, a lung ultrasound examination using pulsed-wave Doppler will be performed on Day 0 and on Day 3 to 5. A bronchoalveolar lavage will also be performed on Day 0.
16108475|NCT02100436|Biological|Influenza Virus Vaccine, Monovalent A/H3N2v A/Minnesota/11/2010 NYMC X-203|A unadjuvanted subvirion monovalent inactivated split influenza virus vaccine (H3N2v MIV) produced in eggs. Subjects are enrolled in 3 cohorts stratified by age. 6-35 month old subjects receive 2 doses of H3N2v MIV, intramuscularly (IM) as 7.5 micrograms (mcg) of hemagglutinin (HA)/0.25 milliliter (mL) dose, 21 days apart, or 2 doses of H3N2v MIV, IM as 15mcg HA/0.5mL dose, 21 days apart. 3-8 year old subjects and 9-17 year old subjects receive 2 doses of H3N2v MIV, IM as 15mcg HA/0.5mL dose, 21 days apart.
16108476|NCT02100423|Drug|curcumin|Given PO
16108477|NCT02100423|Dietary Supplement|cholecalciferol|Given PO
16108478|NCT02100423|Other|laboratory biomarker analysis|Correlative studies
16108479|NCT02100423|Other|pharmacological study|Correlative studies
16108480|NCT02100410|Device|Delefilcon A toric contact lens T1|Iteration 2-87-1 with embossed mark
16108481|NCT02100410|Device|Delefilcon A toric contact lens T2|Iteration 2-87-1 without embossed mark
16108482|NCT02100410|Device|Delefilcon A toric contact lens T3|Iteration 2-87-2 with embossed mark
16108483|NCT02100410|Device|Delefilcon A toric contact lens T4|Iteration 2-87-2 without embossed mark
16108484|NCT02100410|Device|Delefilcon A toric contact lens T5|Iteration 2-87-3 with embossed mark
16108485|NCT02100410|Device|Delefilcon A toric contact lens T6|Iteration 2-87-3 without embossed mark
16108486|NCT02100397|Biological|Salmonella enterica serovar Paratyphi A (strain NVGH308)|Ingestion of 1-5x10³ to 1-5x10⁵ colony forming units (CFU) of the challenge strain after bicarbonate buffer solution.
16108487|NCT02100384|Procedure|Peri-implant maintenance|The peri-implant maintenance will be performed by two experienced Registered Dental Hygienists with titanium scalers or ultrasonic instrumentation
16108488|NCT02100371|Drug|BMS-833923|BMS-833923, by mouth, at the dose and schedule administered while enrolled in CA194002.
16108489|NCT02100319|Drug|Azilsartan|Azilsartan tablets
16108490|NCT02100306|Behavioral|Auditory Feedback 100%|Patients will receive constant auditory feedback across training trials.
16108491|NCT02100306|Behavioral|Auditory Feedback 50% alternate|Patients will receive alternating auditory feedback (1 trial auditory feedback; 1 trial no auditory feedback) across trials
16108492|NCT02100293|Drug|magnesium sulfate 30 mg/kg|Patients in each group received the magnesium sulfate 30 mg/kg for 2 min in 0.9% normal saline (total volume 100 ml) intravenously for 5 min before induction of anesthesia
16108493|NCT02100293|Drug|saline|Patients in each group received 0.9% normal saline (total volume 100 ml) alone intravenously for 5 min before induction of anesthesia
16108494|NCT02100280|Drug|deep block|sugammadex 4 mg/kg are administered IV for reversal of neuromuscular block
16108495|NCT02100267|Drug|Methacholine Chloride (SK-1211)|Subjects received saline and 0.039-25 mg/mL of Methacholine chloride
16108496|NCT02100254|Behavioral|behavioral intervention|View personal narrative informational video
16108497|NCT02100254|Behavioral|behavioral intervention|View fact-based informational video
16108498|NCT02100241|Procedure|Active stretching|The participants performed three specific exercises of static active stretching of the hamstring muscles, maintaining the maximum tightness that was tolerable without pain for 15 seconds. Each exercise were performed twice, with a total of six repetitions.
16108499|NCT02100228|Drug|Apixaban|Oral, 2.5 or 5 mg BID
16108500|NCT02100228|Drug|Parenteral heparin and/or oral Vitamin K antagonist|Parenteral heparin and/or locally used oral Vitamin K antagonist e.g. warfarin (excludes other novel oral anticoagulants)
16108501|NCT02100215|Other|Common readings and educational handouts|Participants in all groups have common readings related to policies for nursing care in acute care facilities. There will be additional handouts related to performing safety checks and a focused physical assessment.
16108502|NCT02100215|Other|Expert Modeling|70 minutes of expert modeling videos
16108503|NCT02100215|Other|Voice Over Power Point|60 minutes of Voice Over PowerPoint presentations
16108504|NCT02100202|Other|Placebo|
16108505|NCT02100202|Dietary Supplement|BioTurmin (Curcuma longa rhizomes extract)|
16108506|NCT02100202|Dietary Supplement|BioTurmin-WD (Water dispersible curcuminoids)|
16108507|NCT02100202|Dietary Supplement|MaQxan (Tagetes erecta flower extract)|
16108508|NCT02100189|Other|Cytology Specimen Collection Procedure|Undergo esophageal cytology collection
16108509|NCT02100189|Procedure|Esophagogastroduodenoscopy|Undergo standard EGD or endoscopy
16108510|NCT02100189|Other|Laboratory Biomarker Analysis|Correlative studies
16108511|NCT02100176|Other|Multidisciplinary intensive rehabilitation treatment|The first session comprises cardiovascular warm-up activities, relaxation exercises, muscle-stretching exercises, exercises to improve the range of motion of spinal, pelvic and scapular joints, exercises to improve the functionality of the abdominal muscles, and postural changes in supine position. The second session comprises exercises to improve balance and gait using a stabilometric platform with a visual cue and treadmill plus. The last session is a session of occupational therapy aimed to improve autonomy in daily living activities.
16108512|NCT02100176|Drug|Rotigotine|Rotigotine 2-8 mg/24 h
16108513|NCT02100163|Behavioral|Virtual Reality Hypnosis|The patient receives virtual reality hypnosis daily.
16108514|NCT02100163|Behavioral|Audio Hypnosis|Patient will listen to an Audio Hypnosis recording daily.
16108515|NCT02100163|Other|Standard treatment|
16108516|NCT02100150|Drug|NNZ-2566|Glycyl-L-2-Methylpropyl-L-Glutamic Acid (NNZ-2566) supplied as a lyophilized powder (3g in 30 milliliter vials) for reconstitution with strawberry flavored solution 0.5% v/v in Water for Injection.
16108517|NCT02100150|Drug|Placebo|Strawberry flavored solution 0.5% v/v in Water for Injection
16108518|NCT02100137|Other|vaginal ultrasound|vaginal ultrasound performed at a routine gyn examination
16108519|NCT02100124|Behavioral|Reproductive Life Planning (RLP)|
16108520|NCT02100124|Behavioral|Contraceptive Action Planning|
16108521|NCT02100124|Behavioral|Contraception information|
16108522|NCT02100085|Biological|GX-188E|In phase I study, 9 patients were assigned to three dose groups (1mg, 2mg and 4mg) and were administered three times with GX-188E by electroporation during an entire period of study. After the final administration, the follow-up will be conducted to investigate safety and efficacy aspects.
16108523|NCT02100072|Device|Nd:YAG 1440 nm laser|
16108524|NCT02100059|Other|Transcutaneous Electrical Nerve Stimulation|The TENS electrodes will be applied on the medial and lateral superior, as well as the medial and lateral inferior, borders of the patella. A continuous biphasic pulsatile current (150 Hz, phase duration 150 µs) will be applied at an intensity that produces a comfortable sensation but not a muscle contraction. The duration of intervention will be 40 minutes.
16108525|NCT02100046|Drug|Zarontin® (ethosuximide) and Stodal®|
16108526|NCT02100033|Device|acupuncture|
16108527|NCT02100020|Other|Direct Referral to physical activity|Participants randomized to the Direct Referral to Physical Activity Arm will be provided with a referral to a physical activity program in their community and will be closely monitored in this program for 16 wks.
16108715|NCT02098811|Device|940nm Laser|Patient will be treated with 940nm Laser prior to abdominoplasty
16108528|NCT02100007|Drug|ME-344|"Part 1: ME-344 IV at 10 mg/kg on Days 1, 8, 15, and 22 of each 28-day cycle. Part 2: ME-344 IV at the dose defined in Part 1 on Days 1, 8, 15, and 22 of each 28 day cycle.
~Patients will be allowed to continue receiving ME-344 infusions weekly according to the assigned dose level as long as there is clinical benefit to the patient as assessed by the Investigator."
16108529|NCT02100007|Drug|Topotecan|Part 1: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle. Part 2: Topotecan 4 mg/m2 i.v. weekly on Days 1, 8 and 15 of each 28-day cycle.
16108530|NCT02099994|Biological|Ad35-GRIN|intramuscular administration of Ad35-GRIN 5 x 10^10 vp or saline placebo
16108531|NCT02099994|Biological|MVA.HIVconsv|IM administration of MVA.HIVconsv 2 x 10^8 pfu or saline placebo
16108532|NCT02099994|Biological|pSG2.HIVconsv DNA|IM administration of pSG2.HIVconsv DNA 4 mg or saline placebo
16108533|NCT02099994|Biological|Electroporated pSG2.HIVconsv|IM administration of electroporated pSG2.HIVconsv 4mg or saline placebo
16108534|NCT02099981|Drug|Aminoguanidine|
16108535|NCT02099968|Behavioral|Comprehensive Lifestyle Modification|"Fasting (1st week), followed by:
~Vegetarian and modified DASH diet (plant-based, low-salt)
~Aerobic exercise
~Stress reduction techniques: progressive muscle relaxation, meditation, yoga"
16108536|NCT02099968|Behavioral|Standard Lifestyle Modification / modified DASH|"Modified DASH (vegetarian focused, plant-based, low-salt)
~Aerobic exercise
~Stress reduction techniques: progressive muscle relaxation"
16108537|NCT02099955|Drug|Vitamin D3|4000 IU/day or 2000 IU/day for 12 weeks
16108538|NCT02099942|Device|V8 Balloon Aortic Valvuloplasty (BAV) Catheter|"The V8 device can be used for BAV as follows:
~as stand-alone intervention
~as a bridge to transcatheter aortic valve replacement (TAVR)
~as a bridge to surgical aortic valve replacement (SAVR)
~as an intraprocedural predilatation prior to TAVR"
16108539|NCT02099929|Other|Coffee with Sugar|300mL of Coffee with 30g of Sugar
16108540|NCT02099929|Other|Coffee without Sugar|300mL of Coffee without Sugar
16108541|NCT02099929|Other|Decaffeinated Coffee without Sugar|300mL of Decaffeinated Coffee without Sugar
16108542|NCT02099929|Other|Water with Sugar|300mL of Water with 30g of Sugar
16108543|NCT02099929|Other|Water without Sugar|300mL of Water without Sugar
16108544|NCT02099916|Drug|gonadotropins plus DHEA|Women in the DHEA group will received 25 mg of DHEA three times a day for at least 12 weeks.
16108545|NCT02099916|Drug|Gonadotropins|All patients will be stimulated with a fixed GnRH-antagonist protocol. Ovarian stimulation will be initiated with 450 IU of gonadotropins either in the form of a combination of highly purified urinary FSH and LH or with a combination of Rec FSH and Rec LH.
16108546|NCT02099903|Device|transcatheter renal denervation|Renal sympathetic denervation with an irrigated radiofrequency catheter.
16108547|NCT02099890|Dietary Supplement|Omega-3|
16108548|NCT02099890|Dietary Supplement|Vegetation Protein Powder|
16108549|NCT02099890|Dietary Supplement|InflanNox|
16108550|NCT02099890|Dietary Supplement|Anti-oxidant Network|
16108551|NCT02099890|Dietary Supplement|Chlorella|
16108552|NCT02099877|Drug|Fentanyl|Epidural analgesia will be initiated with 100µg of epidural fentanyl
16108553|NCT02099864|Drug|Enzalutamide|Given PO
16108554|NCT02099851|Device|Carotid body ablation (Cibiem)|
16108555|NCT02099838|Drug|Pioglitazone and Metformin|taking 1 tablet twice a day (before breakfast and before dinner) orally for 12 weeks
16108556|NCT02099838|Drug|Placebo|taking 1 tablet twice a day (before breakfast and before dinner) orally for 12 weeks
16108557|NCT02099825|Drug|d-cycloserine and mifepristone|All participants will receive a one-time only dose of both, d-cycloserine and mifepristone at Session 2
16108558|NCT02099799|Behavioral|Pedometer and Website|Pedometer and website with feedback, goal setting, educational and motivational content, and community forum.
16108559|NCT02099786|Other|COMP-VA|Hearing testing at each treatment interval by the comp-va audiologist
16108560|NCT02099786|Other|Standard of care|Hearing testing done in the audiology clinic after oncology referral or patient self referral
16108561|NCT02099760|Device|STD testing (GC/Ct/trich)|
16108562|NCT02099747|Drug|hATG|
16108563|NCT02099747|Drug|CsA|
16108564|NCT02099747|Drug|Eltrombopag|
16108565|NCT02099734|Behavioral|Questionnaires|
16108566|NCT02099734|Other|sample of blood or saliva|A sample of blood or saliva will be obtained for DNA extraction. Approximately 2-4 tubes of blood will be collected or one tablespoon of saliva. If a participant has already provided a DNA sample for another MSKCC IRB approved protocol, they may not need to provide an additional sample.
16108567|NCT02099721|Device|ICD or CRT-D Device|Subjects who receive an ICD/CRT-D device implant will be implanted and follow protocol-specified programming. The programming is not investigational. Consistent programming is desirable in order to compare groups during statistical analysis.
16108568|NCT02099708|Drug|Lansoprazole|Lansoprazole Capsules 15 mg/ Orally Disintegrating (OD) Tablets 15 mg
16108569|NCT02099695|Drug|Oxybutynin|The doses will increase due to the absence/ lack of therapeutic response of the previous dose assessed during the study visits.
16108570|NCT02099695|Drug|Placebo|The quantity of tablets will increase due to the absence/ lack of therapeutic response.
16108571|NCT02099682|Drug|Lansoprazole|Lansoprazole Capsules 15/ OD Tablets
16108572|NCT02099669|Other|Red Blood Cell Transfusions|
16108573|NCT02099656|Drug|Lebrikizumab|Lebrikizumab will be administered by SC injection on Day 1, Day 8, Week 4, and Week 8.
16108574|NCT02099656|Drug|Placebo|Lebrikizumab matching placebo will be administered by SC injection on Day 1, Day 8, Week 4, and Week 8.
16108575|NCT02099656|Drug|Inhaled corticposteroids (ICS)|Participants will continue their ICS controller therapy, as they are receiving prior to screening, throughout the study. Protocol does not specify any particular ICS.
16108576|NCT02099656|Drug|Second Asthma Controller Medication|Participants will continue their asthma controller therapy, as they are receiving prior to screening, throughout the study.
16108577|NCT02099617|Procedure|Percutaneous Coronary Intervention (PCI) with short DAPT duration with Synergy II stent|
16108578|NCT02099617|Procedure|Percutaneous Coronary Intervention (PCI) with short DAPT duration with Omega stent|
16108579|NCT02099617|Procedure|Percutaneous Coronary Intervention (PCI) with short DAPT duration with Rebel stent|
16108580|NCT02099604|Drug|Vitamin D + Pegylated Interferon Alpha 2b + Ribavirin|Vitamin D ARM: 28000UI/week during 4 weeks (lead in phase) then 28000 UI/week associated with PegIFN/RBV during 48 weeks
16108581|NCT02099591|Drug|Naloxegol|Opioid Antagonist
16108582|NCT02099578|Dietary Supplement|25 g of Freeze-dried Strawberry Powder|Participants will be given one packet of 25 g of freeze-dried strawberry powder and one packet of 25 g of placebo powder and asked to consume one packet in the morning and one at night.
16108583|NCT02099578|Dietary Supplement|50 g of Freeze-dried Strawberry Powder|Participants will be given two packets of 25 g of freeze-dried strawberry powder and asked to consume one packet in the morning and one at night.
16108584|NCT02099578|Dietary Supplement|Placebo Powder|Participants will be given two packets of 25 g of placebo powder and asked to consume one packet in the morning and one at night.
16108585|NCT02099539|Biological|ALT-803|Intravenous infusion for cohort 1, 2, 3 and 4; subcutaneous injection for cohort 5, 6 and 7; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
16108586|NCT02099513|Device|The Mobile Health Platform|
16108587|NCT02099500|Procedure|Liposuction|Liposuction using aspiration syringe and tumescent local anesthesia
16108588|NCT02099500|Other|Stem Cell Injection|Stem cell implantation will be performed using intramuscular injection into the affected ischemic site of interest
16108589|NCT02099487|Radiation|Radiation|hypofractionated IMRT
16108590|NCT02099474|Other|Study of pharmacokinetic properties of raltegravir during the 3rd trimester of pregnancy|Introduction of a catheter for performing 5 blood samples in pregnant women infected by HIV-1, before the raltegravir intake, 0.5, 3, 8 and 12 hours after the intake at each of two visits (between 30 and 37 weeks of amenorrhea, and 4 to 6 weeks after delivery)
16108591|NCT02099461|Drug|Denosumab|Single sucutaneous dose
16108592|NCT02099461|Procedure|Percutaneous core needle breast biopsy|
16108593|NCT02099435|Device|Hemospray|The Hemospray™ device comes in a 7F kit and a 10F kit. Each kit includes two 220 cm Teflon application catheters, a handle with CO2 cartridge and a syringe containing approximately 20 g of the Hemospray™ material. Hemospray™ is a proprietary inorganic mineral powder that acts as a mechanical barrier when sprayed over a bleeding lesion and the surrounding mucosa.
16108594|NCT02099409|Device|FLORENCED2|FLORENCED2 device ensures the closed loop between Freestyle Navigator II and the DANA DIABECARE R
16108595|NCT02099396|Drug|Docetaxel+lobaplatin|
16108596|NCT02099396|Drug|Gemcitabine+lobaplatin|
16108597|NCT02099383|Other|normal saline|intravenous normal saline 20cc per kilogram of body weight over a period of 8 hours
16108598|NCT02099357|Dietary Supplement|Creatine|Daily supplementation with 3g of monohydrate creatine during 8 weeks
16108599|NCT02099357|Dietary Supplement|Placebo|
16108600|NCT02099357|Dietary Supplement|Vitamin D|Vitamin D supplementation with 25000 IU each two weeks during eight weeks
16108601|NCT02099344|Device|Artegraft|Surgical placement of graft for hemodialysis access
16108602|NCT02099344|Device|Propaten|Surgical placement of graft for hemodialysis access
16108603|NCT02099331|Drug|Melatonin|
16108604|NCT02099331|Drug|Placebo (for Melatonin)|Sugar pill manufactured to mimic Melatonin 20 mg
16108605|NCT02099318|Other|Active SRP cases|The SRP involves preoperative rehearsal and planning. Similarly to the CT/MRI studies, the SRP will be available for surgeons during the surgery for evaluation of optional surgical approaches.
16108606|NCT02099318|Other|Control cases|Control cases will consist of video recorded cases done in the exact same way as they have been performed prior to the implementation of the SRP for neurosurgery cases. Due to the alternation of cases, both the SRP and control cases will take place in the same period.
16108607|NCT02099305|Other|Adolescent Depression Awareness Program (ADAP)|Depression education curriculum delivered by trained school health education teachers or other school personnel
16108608|NCT02099292|Drug|Rituximab and DexaBEAM|combination treatment
16108609|NCT02099279|Device|echocardiography examination|patients underwent echocardiography examination
16108610|NCT02099266|Device|Administration of hyperbaric oxygen|Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours
16108611|NCT02099253|Drug|Dexmedetomidine 01|Initial doses was 1μg/kg, with dose adjustment intervals of 0.05μg/kg.
16108612|NCT02099253|Drug|Dexmedetomidine 02|Initial doses was 0.7μg/kg, with dose adjustment intervals of 0.05μg/kg.
16108613|NCT02099240|Drug|oral antibiotics|intravenous antibiotics with early switch to oral antibiotics, antibiotic type will be dependent on bacteria type
16108614|NCT02099240|Procedure|intravenous antibiotics|intravenous antibiotics for the full duration of therapy, antibiotic type will be dependent on bacteria type
16108615|NCT02099214|Device|3Tesla cardiac MRI|
16108616|NCT02099214|Device|Electrocardiogram (EKG)|
16108617|NCT02099214|Biological|Iron and cardiac markers|Serum iron, serum transferrin, transferrin saturation, serum ferritin, NT-proBNP
16108618|NCT02099214|Biological|Pregnancy test|Beta-hCG
16108619|NCT02099214|Device|Echocardiography at rest|Transthoracic echocardiograph
16108620|NCT02099214|Biological|Urinary pregnancy test|
16108621|NCT02099214|Device|3Tesla abdominal MRI|
16108622|NCT02099201|Drug|ACT-389949 40 mg|
16108623|NCT02099201|Drug|ACT-389949 200 mg|Predicted dose
16108624|NCT02099201|Drug|ACT-389949 800 mg|Predicted dose
16108625|NCT02099201|Drug|ACT-389949 (Group C1 dose to be selected)|
16108626|NCT02099201|Drug|ACT-389949 (Group C2 dose to be selected)|
16108627|NCT02099201|Drug|Placebo|
16108628|NCT02099188|Drug|Cisplatin|80 mg/m2 or 33 mg/m2/day or 100 mg/m2 - Concentrate for solution for infusion
16108629|NCT02099188|Drug|Docetaxel|75 mg/m2 - Concentrate for solution for infusion
16108630|NCT02099188|Drug|5-fluorouracil|800 mg/m2/day - Concentrate for solution for infusion
16108631|NCT02099188|Drug|Etoposide|150 mg/m2/day - Concentrate for solution for infusion
16108632|NCT02099188|Drug|Adriamycin|20 mg/m2/day - Powder for solution for infusion
16108633|NCT02099188|Drug|Ifosfamide|3000 mg/m2/day - Powder for solution for infusion
16108634|NCT02099188|Drug|Leucovorin|250 mg/m2/day - Powder for solution for infusion
16109285|NCT02094651|Other|Placebo|The placebo is an inactive substance that looks like the active drug.
16108635|NCT02099188|Radiation|Radiotherapy - Patients needing Elective Nodal Volume (ENI)|"LR-PTV: 50.4-54 Gy with 1.8-2 Gy per fraction will be prescribed. This volume will always be treated with photons IMRT.
~Particle boost with ENI:
~HR-PTV: carbon ions 18 - 21 Gy (relative biological effectiveness, RBE) in fractions of 3 Gy (RBE) without concomitant chemotherapy IR-PTV: this volume is optional, if used it will receive the first 3 fractions i.e. 9 Gy (RBE) of the boost.
~Photons boost with ENI. HR-PTV: at least 70 Gy with 2-2.12 Gy per fraction and 66 Gy at 2Gy per fraction in radical setting will be prescribed. IR-PTV: 59.4-60 Gy with 1.8 Gy-2 Gy per fraction will be prescribed."
16108636|NCT02099188|Radiation|Radiotherapy - Patients not needing ENI|"Treatment with particles. IR-PTV: this volume can be larger or equal to HR-PTV according to individual situations. 50.4-54 Gy with 1.8-2 Gy per fraction will be prescribed to IR-PTV with protontherapy with concomitant chemotherapy. HR-PTV: carbon ions 18 - 21 Gy (RBE) in fractions of 3 Gy (RBE) without concomitant chemotherapy. The first 3 fractions may be given to the bigger IR-PTV.
~Treatment with photons. HR-PTV: at least 70 Gy with 2-2.12 Gy per fraction and 66 Gy at 2Gy per fraction in radical setting will be prescribed. IR-PTV: 59.4-60 Gy with 1.8 Gy-2 Gy per fraction will be prescribed."
16108637|NCT02099188|Radiation|Radiotherapy - Patients needing curative neck irradiation|"LR-PTV: 50.4-54 Gy with 1.8-2 Gy per fraction will be prescribed. This volume will always be treated with photons IMRT.
~Particle boost. HR-PTV: carbon ions 18 - 21 Gy (RBE) in fractions of 3 Gy (RBE) without concomitant chemotherapy IR-PTV: this volume is optional, if used it will receive the first 3 fractions i.e. 9 Gy (RBE) of the boost.
~Photons boost. HR-PTV: at least 70 Gy with 2-2.12 Gy per fraction and 66 Gy at 2Gy per fraction in radical and postoperative setting will be prescribed. IR-PTV: 59.4-60 Gy with 1.8 Gy-2 Gy per fraction will be prescribed."
16108638|NCT02099175|Drug|Cisplatin|80 mg/m2 or 33 mg/m2 or 100 mg/m2 - Concentrate for solution for infusion.
16108639|NCT02099175|Drug|Docetaxel|75 mg/m2 - Concentrate for solution for infusion
16108640|NCT02099175|Drug|5-fluorouracil|800 mg/m2/day - Concentrate for solution for infusion
16108641|NCT02099175|Drug|Etoposide|150 mg/m2/day - Concentrate for solution for infusion
16108642|NCT02099175|Drug|Adriamycin|20 mg/m2/day - Powder for solution for infusion
16108643|NCT02099175|Drug|Ifosfamide|3000 mg/m2/day - Powder for solution for infusion
16108644|NCT02099175|Drug|Leucovorin|250 mg/m2/day - Powder for solution for infusion
16108645|NCT02099175|Radiation|Radiotherapy - Patients needing Elective Nodal Volume (ENI)|"Particle boost with ENI:
~HR-PTV: carbon ions 18 - 21 Gy (RBE) in fractions of 3 Gy (RBE) without concomitant chemotherapy IR-PTV: this volume is optional, if used it will receive the first 3 fractions i.e. 9 Gy (RBE) of the boost.
~Photons boost with ENI:
~HR-PTV: at least 70 Gy with 2-2.12 Gy per fraction and 66 Gy at 2Gy per fraction in radical and postoperative setting will be prescribed. IR-PTV: 59.4-60 Gy with 1.8 Gy-2 Gy per fraction will be prescribed"
16108646|NCT02099175|Radiation|Radiotherapy - Patients not needing ENI|"Treatment with particles IR-PTV: this volume can be larger or equal to HR-PTV according to individual situations. 50.4-54 Gy with 1.8-2 Gy per fraction will be prescribed to IR-PTV with protontherapy with concomitant chemotherapy. HR-PTV: carbon ions 18 - 21 Gy (RBE) in fractions of 3 Gy (RBE) without concomitant chemotherapy. The first 3 fractions may be given to the bigger IR-PTV.
~Treatment with photons. HR-PTV: at least 70 Gy with 2-2.12 Gy per fraction and 66 Gy at 2Gy per fraction in radical and postoperative setting will be prescribed. IR-PTV: 54-60 Gy with 1.8 Gy-2 Gy per fraction will be prescribed"
16108647|NCT02099175|Radiation|Radiotherapy - Patients needing curative neck irradiation|"LR-PTV: 50.4-54 Gy with 1.8-2 Gy per fraction will be prescribed. This volume will always be treated with photons IMRT.
~Particle boost:
~HR-PTV: carbon ions 18 - 21 Gy (RBE) in fractions of 3 Gy (RBE) without concomitant chemotherapy IR-PTV: this volume is optional, if used it will receive the first 3 fractions i.e. 9 Gy (RBE) of the boost.
~Photons boost. HR-PTV: at least 70 Gy with 2-2.12 Gy per fraction and 66 Gy at 2Gy per fraction in radical and postoperative setting will be prescribed. IR-PTV: 59.4-60 Gy with 1.8 Gy-2 Gy per fraction will be prescribed.
~Concomitant chemotherapy will be administered only in case of radiotherapy with photon beams exclusively."
16108648|NCT02099162|Device|coronary stents|e.g. Sirolimus eluting stent, Paclitaxel-eluting stent, Zotarolimus-eluting stent, Everolimus-eluting stent, Biolimus eluting stent, EPC(endothelial progenitor cell) Capture stent, etc
16108649|NCT02099136|Procedure|UV Light Therapy|Undergo UV-irradiation
16108650|NCT02099136|Other|Placebo|Given PO
16108651|NCT02099136|Drug|Celecoxib|Given PO
16108652|NCT02099136|Procedure|Biopsy|Undergo skin biopsy
16108653|NCT02099136|Other|Imaging Biomarker Analysis|Correlative studies
16108654|NCT02099123|Drug|Atorvastatin|Atorvastatin 20 mg tablet
16108655|NCT02099123|Drug|Placebo (for Atorvastatin)|Inactive pill manufactured to mimic Atorvastatin 20 mg tablet
16108656|NCT02099110|Drug|Matching Placebo to Ertugliflozin 5 mg|Placebo to ertugliflozin 5 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period
16108657|NCT02099110|Drug|Matching Placebo to Ertugliflozin 10 mg|Placebo to ertugliflozin 10 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period
16108658|NCT02099110|Drug|Matching Placebo to sitagliptin 100 mg|Placebo to sitagliptin 100 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period
16108659|NCT02099110|Drug|Ertugliflozin 5 mg|Ertugliflozin 5 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period
16108660|NCT02099110|Drug|Ertugliflozin 10 mg|Ertugliflozin 10 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period
16108661|NCT02099110|Drug|Sitagliptin 100 mg|Sitagliptin 100 mg tablet, oral, once daily for 52 weeks during the double-blind treatment period
16108662|NCT02099110|Drug|Metformin >= 1500 mg/day|Metformin >= 1500 mg/day, tablets, oral, for 52 weeks while receiving blinded investigational product during the double-blind treatment period
16108663|NCT02099110|Biological|Insulin Glargine Rescue Medication|Open-label insulin glargine, subcutaneous injection, as required as a rescue medication; dose determined per the investigator's discretion
16108664|NCT02099110|Drug|Glimepiride Rescue Medication|Open-label glimepiride tablets, oral, as required as a rescue medication, dose determined per the investigator's discretion
16108665|NCT02099097|Other|web-based video game (Quit IT)|
16108716|NCT02098798|Procedure|HD Colonoscopy|High definition colonoscopy procedure in surveillance colonoscopy
16108717|NCT02098798|Procedure|HD Colonoscopy + iSCAN|
16108718|NCT02098798|Procedure|HD Colonoscopy + dye spray|
16108666|NCT02099097|Behavioral|Questionnaires|In order to maximize survey the response rate, patients will be mailed a reminder letter approximately two weeks before the 1 month follow up surveys are due. If the survey is not returned, patients will be sent additional reminders on the survey due date as well as two weeks past the due date.
16108667|NCT02099097|Other|Salvia sample|The investigators will inform patients prior to obtaining their self-reports that a saliva test or expired CO sample for those using NRT or electronic cigarettes will be performed to examine recent tobacco exposure.
16108668|NCT02099084|Drug|Teduglutide|Participants will receive Teduglutide 0.05 mg/kg/d administered subcutaneously.
16108669|NCT02099084|Drug|Placebo|Participants will receive placebo matching study drug, administered subcutaneously.
16108670|NCT02099071|Drug|ACT-389949 1 mg|
16108671|NCT02099071|Drug|ACT-389949 5 mg|
16108672|NCT02099071|Drug|ACT-389949 20 mg|
16108673|NCT02099071|Drug|ACT-389949 50 mg|
16108674|NCT02099071|Drug|ACT-389949 100 mg|
16108675|NCT02099071|Drug|ACT-389949 200 mg|
16108676|NCT02099071|Drug|ACT-389949 500 mg|
16108677|NCT02099071|Drug|ACT-389949 1000 mg|
16108678|NCT02099071|Drug|Placebo|
16108684|NCT02099045|Device|Point of Care Ultrasonography|
16108685|NCT02099032|Other|3g milk polar lipid fortified cheese consumption|Women will have to consume daily 100g of a 3g milk polar lipid fortified cheese product instead of usual cheese products during four weeks.
16108686|NCT02099032|Other|5g milk polar lipid fortified cheese consumption|Women will have to consume daily 100g of a 5 g milk polar lipid fortified cheese product instead of usual cheese products during four weeks.
16108687|NCT02099032|Other|Unfortified cheese product consumption|Women will have to consume daily 100g of a unfortified cheese product instead of usual cheese products during four weeks
16108688|NCT02099006|Drug|Amitriptyline|Topical application of the drug at a 2% concentration in combination with 2% Baclofen
16108689|NCT02099006|Drug|Baclofen|Used topically at 2% concentration in combination with 2% amitriptyline
16108690|NCT02099006|Drug|Ketoprofen|To be applied topically at a 10% concentration
16108691|NCT02099006|Drug|Ketamine|To be applied topically at a 10% concentration
16108692|NCT02099006|Drug|Loperamide|To be applied topically at a 5% concentration
16108693|NCT02099006|Drug|Gabapentin|To be applied topically at a 6% concentration
16108694|NCT02099006|Drug|placebo|Compounding base to be used alone as a placebo
16108695|NCT02098993|Drug|Unfractionated heparin|
16108696|NCT02098980|Dietary Supplement|Vitamin D|
16108697|NCT02098967|Drug|RO6839921|Non-escalating IV doses given on Days 1-5 of Cycle 1.
16108698|NCT02098967|Drug|RO6839921|Escalating IV doses of RO6839921 in solid tumor patients. Dose escalation will be calculated using the new Continual Reassessment Method (nCRM). RO6839921 will be given on Days 1-5 of 28-day cycles. Treatment will continue until disease progression, unacceptable toxicity or study discontinuation.
16108699|NCT02098967|Drug|RO6839921|Escalating IV doses of RO6839921 in AML patients. Escalation will follow an adapted rolling 6 design. Starting dose </= dose inducing Grade 2 toxicity in patients with solid tumors. RO6839921 will be given on Days 1-5 of 28-day cycles. Treatment will continue until disease progression, unacceptable toxicity or study discontinuation.
16108700|NCT02098954|Drug|Gemcitabine platinum combined with erlotinib|patients will received a 28 days gemcitabine platinum combined with erlotinib scheme, after 4 cycles combined chemotherapy, patients will receive erlotinib for maintain treatment until progression disease.Gemcitabine for day 1 and day 8, 1250mg/m2. Platinum for day 1, 75mg/m2. Erlotinib for day 9-21 during combined chemotherapy, 150mg/day, then erlotinib should be used daily until patients develop progression disease.
16108701|NCT02098928|Behavioral|Hand-acupuncture|Use Hand-acupuncture directly. Four acupoints:Tianshu,Zigong,Guanyuan and Sanyinjiao. Every patient are supposed to have 24 times acupuncture treatment. 30 minutes per time.
16108702|NCT02098928|Device|Electrico-acupuncture|Use Electrico-acupuncture device to therapy. Four acupoints:Tianshu,Zigong,Guanyuan and Sanyinjiao. Every patient are supposed to have 24 times acupuncture treatment. 30 minutes per time.
16108703|NCT02098915|Drug|intravenous metoclopramide|the experimental arm will receive intravenous metoclopramide dosed according to the current Sick Kids guidelines based upon weight and age
16108704|NCT02098915|Other|Placebo|equivalent volume to intravenous metoclopramide (dosed according to the current Sick Kids guidelines based upon weight and age ) of sterile sodium chloride 0.9% injection as a placebo
16108705|NCT02098902|Behavioral|Smart Moms Intervention|Reduction in child sugar-sweetened beverage consumption and maternal caloric beverage consumption, in addition to self-selected 100-calorie dietary and physical activity changes made by the mother to promote modest weight loss. Content will be delivered via one in-person group meeting, weekly online lessons, and weekly text messages. Mothers will self-monitor their weight and their own and their child's beverage consumption via text message every 2-3 days.
16108706|NCT02098889|Drug|hyoscine-N-butyl bromide(HBB)|A single dose intravenously(IV) 20 mg (20ml) hyoscine-N-butyl bromide(HBB) versus placebo ( a single dose of 20ml IV NaCl) on the active phase of labor
16108707|NCT02098889|Drug|Saline|placebo ( a single dose of 20ml IV NaCl) versus A single dose intravenously(IV) 20 mg (20ml) hyoscine-N-butyl bromide(HBB)on the active phase of labor
16108708|NCT02098876|Device|Resolute Integrity Zotarolimus eluting stent|PCI with Resolute stent
16108709|NCT02098876|Device|Xience Xpedition everolimus eluting stent|PCI with Xience stent
16108710|NCT02098837|Drug|Dolutegravir|Dolutegravir 50mg once daily
16108711|NCT02098824|Drug|Galantamine|Single administration of capsule containing 16 mg of Galantamine
16108712|NCT02098824|Drug|Methylphenidate|Single administration of capsule containing 10 mg of Methylphenidate
16108713|NCT02098824|Drug|Placebo|Single administration of capsule containing placebo
16108714|NCT02098811|Device|1064nm Laser|Patient will be treated with 1064nm Laser prior to abdominoplasty
16108720|NCT02098772|Drug|Custodiol-N|comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery
16108721|NCT02098772|Drug|Custodiol|comparison of two cardioplegic solutions, Custodiol-N versus Custodiol, in aortic valve surgery
16108722|NCT02098759|Device|epilepsy early diagnosis protocol|Infants that have epileptiform discharges on vEEG and no clinical seizures, if their parents/caregivers give consent, will enter the randomized part of the study. Those children will be randomized into two groups: group A will be diagnosed as having epilepsy after subclinical (electroencephalographic) epileptiform discharges (based on epilepsy early diagnosis protocol), and the patients in group B will be diagnosed as epileptic after clinical seizures appear. All infants diagnosed with epilepsy will receive standard therapy with recommended first line antiepileptic drug starting from the day of diagnosis.
16108723|NCT02098746|Drug|Pioglitazone/glimepiride|Pioglitazone/glimepiride combination tablets
16108724|NCT02098733|Drug|Pioglitazone/glimepiride|Pioglitazone/glimepiride combination tablets
16108725|NCT02098720|Drug|Conbercept|
16108726|NCT02098707|Other|Stabilometric Platform|Stabilometric platform is a device used for assessment and training of balance basing on ground reaction force evaluation in static conditions.
16108727|NCT02098694|Other|Physiotherapy follow-up|"Physiotherapy consultation every 4 months containing assessment of the spine and its mobility, including axial joints, assessment of the patients activity profile.
~Instruction in home-exercises and recommendations for optimization of activity profile. Information regarding the disease and the importance of physical activity and exercise."
16108728|NCT02098668|Other|Fertility treatment|Fertility treatment
16108729|NCT02098655|Other|Stabilometric platform|Stabilometric platform is a device used for assessment and training of balance basing on ground reaction force evaluation in static conditions.
16108730|NCT02098642|Other|MIRT|A 4-week cycle of physiotherapy that entailed three daily sessions, 5 days a week. The first session comprised cardiovascular warm-up activities, relaxation exercises, muscle-stretching, exercises to improve the range of motion of spinal, pelvic and scapular joints, and exercises to improve the functionality of abdominal muscles and postural changes in the supine position. The second session included exercises to improve balance and gait using a stabilometric platform with a visual cue and treadmill training associated with auditory and visual cues (treadmill plus). The last was an occupational therapy session with the aim of improving autonomy in daily living activities.
16108731|NCT02098642|Other|Mobilization of the metatarsophalangeal joint of the hallux|MIRT and mobilization of the metatarsophalangeal joint of the hallux
16108732|NCT02098629|Drug|Milrinone|"Approximately 5 minutes before stent deployment, the patients in the milrinone+esmolol group start to receive continuous intravenous drug infusion for 10 minutes. Milrinone and esmolol (each in 10 ml volume) will be placed in two separate syringes being connected to their respective venous catheters.
~Dosage of study drugs: Syringe #1 Milrinone 5 ug/kg/min Syringe #2 Esmolol 10 ug/kg/min"
16108733|NCT02098629|Drug|Esmolol|"Approximately 5 minutes before stent deployment, the patients in the milrinone+esmolol group start to receive continuous intravenous drug infusion for 10 minutes. Milrinone and esmolol (each in 10 ml volume) will be placed in two separate syringes being connected to their respective venous catheters.
~Dosage of study drugs: Syringe #1 Milrinone 5 ug/kg/min Syringe #2 Esmolol 10 ug/kg/min"
16108734|NCT02098629|Drug|Saline Infusion|Approximately 5 minutes before stent deployment, the patients in the placebo group start to receive continuous intravenous saline infusion for 10 minutes. Two syringes containing saline (10 ml volume in each) will be connected to two separate venous catheters during the infusion
16108735|NCT02098616|Drug|DCV/ASV/BMS-791325|Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) orally twice a day
16108736|NCT02098616|Drug|DCV/ASV/BMS-791325 + RBV|Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day
16108737|NCT02098603|Behavioral|Testing & Intervention|Intervention involves a scripted peer-taught interactive curriculum, which is delivered as twelve, 30 minute weekly sessions incorporated into a team's usual work time or overtime activities.
16108738|NCT02098590|Biological|CPS-immunization|Subjects will be exposed 3 times to bites from 15 NF54 Plasmodium infected mosquitoes during each immunization, while taking chloroquin prophylaxis.
16108739|NCT02098590|Biological|malaria challenge infection, P. falciparum NF135.C10|Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum NF135.C10 sporozoites.
16108740|NCT02098590|Biological|malaria challenge infection, P. falciparum NF166.C8|Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum NF166.C8 sporozoites.
16108741|NCT02098590|Biological|malaria challenge infection, P. falciparum NF54|Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum NF54 sporozoites.
16108742|NCT02098590|Drug|atovaquone/proguanil|All participants will be treated with atovaquone/proguanil when they develop a malaria infection or on day 28 after malaria challenge infection.
16108743|NCT02098577|Other|Crossover|Crossover cycle
16108744|NCT02098577|Other|Stabilometric Platform|This Stabilometric plate allows to assess the balance with an objective and reliable measurement, in both standard static or dynamic unstable condition
16108745|NCT02098564|Other|Joint mobility exercises hand therapy|Joint mobility exercises which are appropriate for their injury, both in the therapy setting and as a home exercise program
16108746|NCT02098564|Other|activity-based hand therapy|intervention involve joint mobility exercises which are appropriate for their injury and training with specific meaningful activities which they performed prior to the hand-related injury. Activity-based hand therapy will be performed both in the therapy setting and as a home exercise program.
16108747|NCT02098551|Other|SPT and APT|"All patients will be tested by skin prick testing (SPT: Histamine, buffer, commercial birch pollen extract, rBet v 1 (20 and 40 μg/ml), rBet v 1 fragment 1 (20 and 40 μg/ml), rBet v 1 fragment 2 (20 and 40 μg/ml), equimolar rBet v 1 fragment mix (20 and 40 μg/ml) in duplets.
~Atopy patch testing (APT: birch pollen extract, rBet v 1:160 μg/application, rBet v 1 fragment 1: 160 μg/application, rBet v 1 fragment 2: 160 μg/ml, equimolar mix of rBet v 1 fragments: 160 μg/application; negative control with vaseline alone."
16108783|NCT02098304|Device|Calcivis Caries Activity Imaging System|Teeth imaged with the Calcivis Caries Activity Imaging System
16108784|NCT02098291|Drug|G17DT|
16108785|NCT02098278|Drug|CAT-2003|
16108786|NCT02098278|Drug|Placebo|
16108748|NCT02098538|Drug|Regorafenib|All eligible patients will receive a starting regorafenib dose of 120 mg daily taken orally for 3 weeks in a 4-week cycle. Patients for whom regorafenib dose reduction was not performed or required may have their treatment dose increased to the FDA-approved dose of 160 mg daily orally for 3 weeks in a 4-week cycle in cycle #2 or beyond (this is not mandatory). RECIST v1.1 tumor assessments will be made at baseline (CT or MRI) and then approximately every 2 cycles (or every 8 weeks (+/- 1 week)). After 10 months, imaging will be done every 3 cycles (or every 12 weeks (+/- 1 week)). Patients may remain on study until progression of disease or unacceptable toxicity
16108749|NCT02098512|Drug|Brentuximab Vedotin|"Brentuximab Vedotin will be administered every 21 days starting on or around Day +42 post allogeneic stem cell transplant for a TOTAL of 4 doses as outlined below:
~42 (+/-7 days) Brentuximab Vedotin 1.8 mg/kg (max=180 mg) IV x 1
~63 (+/- 7 days) Brentuximab Vedotin 1.8 mg/kg (max=180 mg) IV x 1
~84 (+/- 7 days) Brentuximab Vedotin 1.8 mg/kg (max = 180 mg) IV x 1
~105 (+/- 7 days) Brentuximab Vedotin 1.8 mg/kg (max=180 mg) IV x 1"
16108750|NCT02098512|Procedure|Allogeneic Stem Cell Transplantation|Following conditioning with chemotherapy, patients will receive stem cells from a matched related or unrelated donor.
16108751|NCT02098512|Drug|Reduced Intensity Conditioning|Patients will receive reduced intensity chemotherapy with one of three regimens: Busulfan/Fludarabine; Gemcitabine/Fludarabine/Melphalan; Fludarabine/Cyclophosphamide
16108752|NCT02098499|Drug|Haloperidol|5mg IV
16108753|NCT02098499|Drug|Metoclopramide 10mg|10mg IV
16108754|NCT02098499|Drug|Diphenhydramine|25mg IV
16108755|NCT02098486|Drug|Moxifloxacin|
16108756|NCT02098486|Drug|ceftriaxone|
16108757|NCT02098473|Drug|RPC4046|
16108758|NCT02098473|Drug|Placebo|
16108759|NCT02098460|Drug|Atorvastatin, Probucol, Cilostazol|
16108760|NCT02098447|Device|PrimeStim|
16108761|NCT02098434|Behavioral|Montreal Imaging Stress Task|Math task developed to induce a stress response in a laboratory setting
16108762|NCT02098421|Drug|Oxytocin|Use of oxytocin while the Foley bulb is in place
16108763|NCT02098408|Behavioral|Cognitive remediation|"Neurocognition will be trained using the NEAR model (Medalia et al. 2003), whereas the training of social cognitive skills will be by use of the SCIT manual (Social Cognition and Interaction Training) developed by Roberts et al. 2014.
~The intervention consists of 24 group sessions taking place once a week (two hours) and additional neurocognitive training at home. Furthermore, there will be a total of 12 individual sessions aiming at bridging the cognitive training to the everyday functioning of the patients."
16108764|NCT02098408|Behavioral|Standard treatment|Patients allocated to the control condition are free to choose whatever standard treatment they are offered by the clinicians managing their treatment. Usually standard treatment consists of regular contact to health professionals in the in- and outpatient facilities in Copenhagen, Denmark, and encompass different kinds of supportive counselling.
16108765|NCT02098395|Drug|liraglutide|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment will receive 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects will receive 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
16108766|NCT02098395|Drug|liraglutide|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment will receive 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects will receive 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
16108767|NCT02098395|Drug|liraglutide|Subjects randomised to 1.8 mg liraglutide treatment as an add-on to their pre-trial insulin treatment will receive 0.6 mg liraglutide for 2 weeks followed by 1.2 mg liraglutide for 2 weeks. After 4 weeks of treatment subjects will receive 1.8 mg liraglutide for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
16108768|NCT02098395|Drug|placebo|Subjects randomised to 0.3 mL liraglutide placebo as an add-on to their pre-trial insulin treatment will receive 0.1 mL for 2 weeks followed by 0.2 mL for 2 weeks. After 4 weeks of liraglutide placebo, subjects will receive 0.3 mL for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
16108769|NCT02098395|Drug|placebo|Subjects randomised to 0.3 mL liraglutide placebo as an add-on to their pre-trial insulin treatment will receive 0.1 mL for 2 weeks followed by 0.2 mL for 2 weeks. After 4 weeks of liraglutide placebo, subjects will receive 0.3 mL for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
16108770|NCT02098395|Drug|placebo|Subjects randomised to 0.3 mL liraglutide placebo as an add-on to their pre-trial insulin treatment will receive 0.1 mL for 2 weeks followed by 0.2 mL for 2 weeks. After 4 weeks of liraglutide placebo, subjects will receive 0.3 mL for 22 weeks. Administered subcutaneously (s.c., under the skin) once daily.
16108771|NCT02098382|Device|Dilapan-S|Dilapan-S synthetic osmotic dilator for cervical ripening prior to labor induction
16108772|NCT02098369|Behavioral|Written education material (basic)|Education material on COPD distributed to all participants.
16108773|NCT02098369|Behavioral|Additional education material|Additional education material sent to participants in the proactive and reactive arms.
16108774|NCT02098369|Behavioral|PELICAN-Proactive|In the proactive arm, calls will be initiated by the coach. The phone calls will involve educational and social support components. PELICAN is grounded on the social cognitive theory of behavior change and seeks to improve patient adherence by addressing patient self-efficacy and outcome expectancy.
16108775|NCT02098369|Behavioral|PELICAN-Reactive|Participants allocated to the reactive PELICAN group will be offered the opportunity to access the COPD Foundation Infoline toll-free.
16108776|NCT02098356|Other|Low Bicarbonate|Low bicarbonate hemodialysis - 30 mEq/L dialysate bicarbonate
16108777|NCT02098343|Drug|APR-246|Intravenous infusion.
16108778|NCT02098343|Drug|Carboplatin and Pegylated Liposomal Doxorubicin Hydrochloride (PLD)|Intravenous infusion.
16108779|NCT02098330|Drug|Ginkgo biloba & Methylprednisolone|Ginkgo biloba 160 mg/day (per oral, 80 mg twice a day) for 1 month. Methylprednisolone 48 mg/day(per oral, once a day for first 9 days. And then methylprednisolone tapering was started every 2 days. The entire duration of methylprednisolone treatment was 14 days.
16108780|NCT02098330|Drug|Ginkgo biloba|Ginkgo biloba 160 mg/day (per oral, 80 mg twice a day) for 1 month.
16108781|NCT02098317|Drug|DHA plus Vitamin D|DHA 500 mg plus Vitamin D 800 IU
16108782|NCT02098317|Drug|Placebo|Placebo pearls mimicking pearls with DHA and Vitamin D
16108787|NCT02098265|Device|Functional Electric Stimulation (FES)|FES uses low energy electrical pulses to artificially generate body movements in individuals with muscle paralysis. FES can be used to generate muscle contraction in otherwise paralyzed limbs to restore function.
16108788|NCT02098265|Behavioral|Behavioral Assessments|These assessments will include measures of upper extremity motor assessments, standard stroke scales, and measures of activities of daily living.
16108789|NCT02098265|Other|Magnetic Resonance Imaging|A functional magnetic resonance image will be collected.
16108790|NCT02098265|Other|EEG|EEG electrodes will be attached to the participant's scalp using a standard, commercially available electrode cap. Proper electrode placement is made according to the international 10-20 system, ensuring complete electrode coverage over sensorimotor cortex.
16108791|NCT02098265|Other|RecoveriX|RecoveriX is a brain driven rehabilitation system for stroke patients that pairs mental activities with motor functions.
16108792|NCT02098265|Other|Delay|10 week delay before intervention
16108793|NCT02098265|Device|BCI-FES|
16108794|NCT02098252|Procedure|Neurosurgery|Surgical resection to be used when the lesion is considered by a multidisciplinary team to be safely 'operable'.
16108795|NCT02098252|Radiation|Radiation therapy|when the AVM is smaller than 3 cm, and considered to not be safely 'operable'.
16108796|NCT02098252|Procedure|Embolization|Curative embolization, when the lesion is considered curable by embolization.
16108797|NCT02098239|Drug|G17DT|
16108798|NCT02098213|Other|Immediate spa treatment|soon after randomization: Spa treatment of 3 weeks. Spa treatment : that best adapted to the concerned pathology and common to all participating of spa resorts (walk in a specially pool, whirlpool bath with automatic air and water massages cycles, massaging shower etc)
16108799|NCT02098213|Other|Late Spa treatment|soon after 4,5 months visit: Spa treatment of 3 weeks. Spa treatment : that best adapted to the concerned pathology and common to all of spa resorts (walk in a specially pool, whirlpool bath with automatic air and water massages cycles, massaging shower etc)
16108800|NCT02098200|Device|TriCinch System|Percutaneous treatment of Tricuspid Regurgitation
16108801|NCT02098187|Drug|Below target dose MP-3180|MP-3180 0.5 µmol/kg (0.186 mg/kg) dose (fluorescent tracer agent) was administered by IV injection over 2 minutes, followed by a 10 mL saline flush IV over 2 minutes.
16108802|NCT02098187|Drug|At target dose MP-3180|MP-3180 1 µmol/kg (0.186 mg/kg) dose (fluorescent tracer agent) was administered by IV injection over 2 minutes, followed by a 10 mL saline flush IV over 2 minutes.
16108803|NCT02098187|Drug|2 times above target dose MP-3180|MP-3180 2 µmol/kg (0.744 mg/kg) dose (fluorescent tracer agent) was administered by IV injection over 2 minutes, followed by a 10 mL saline flush IV over 2 minutes.
16108804|NCT02098187|Drug|4 times above target dose MP-3180|MP-3180 4 µmol/kg (1.488 mg/kg) dose (fluorescent tracer agent) was administered by IV injection over 2 minutes, followed by a 10 mL saline flush IV over 2 minutes.
16108805|NCT02098187|Device|ORFM prototype|The Optical Renal Function Monitor (ORFM) investigational device noninvasively monitors fluorescent light emission from an exogenous tracer agent over time. Prior to administration of MP-3180 and iohexol, ORFM sensor probes were affixed to each of the participants via standard adhesive pads to four locations: forehead, sternum, upper inner arm, side trunk. The administration of the MP-3180 infusion and iohexol infusion occurred at least 15 minutes after the start of the data acquisition software.
16108806|NCT02098187|Other|Iohexol comparator|Iohexol (Omnipaque 300, 5 mL) (comparator agent) was administered by IV injection over 2 minutes after MP-3180 injection, followed by a 10 mL saline flush IV over 2 minutes.
16108807|NCT02098174|Drug|MP-3180|MP-3180 (1 µmol/kg or 0.372 mg/kg) (fluorescent tracer agent) was administered by IV injection (2.5 mL to 3.5 mL for participant weights of 70 kg to 91 kg) over 2 minutes, followed by a 10 mL saline flush IV over 2 minutes.
16108808|NCT02098174|Other|Iohexol comparator|Iohexol (Omnipaque 300, 5 mL) was administered by IV injection over 2 minutes, followed by a 10 mL saline flush IV over 2 minutes.
16108809|NCT02098161|Other|Laboratory Biomarker Analysis|Correlative studies
16108810|NCT02098161|Other|Questionnaire Administration|Ancillary studies
16108811|NCT02098161|Drug|Smac Mimetic LCL161|Given PO
16108812|NCT02098148|Drug|Xenon|
16108813|NCT02098148|Drug|Placebo|
16108814|NCT02098135|Device|ArmeoSenso|Virtual realty therapy with a touchscreen computer and movement sensors, over 42 days.
16108815|NCT02098109|Drug|XM02 Filgrastim|
16108816|NCT02098109|Drug|Filgrastim|
16108817|NCT02098109|Procedure|Apheresis|
16108818|NCT02098109|Drug|Plerixafor|
16108819|NCT02098109|Procedure|Stem Cell Transplant|
16108820|NCT02098096|Other|Negative Work|"Exercise will be performed twice per week for 12 weeks and exercise intensity will be progressed in three phases. These phases are:
~Familiarization
~Acclimatization
~Progression
~Exercise volume will be 3 sets of 10 repetitions (progressing to 4 sets at Week 6) for the knee flexors and extensors.
~All exercise will be supervised by a physical therapist and performed on a Biodex isokinetic dynamometer."
16108821|NCT02098096|Other|Stretching|Home exercise program will be performed by the Placebo Comparator group and feature stretching over the 12 week intervention period.
16108822|NCT02098057|Dietary Supplement|Gluten Healthy|Assessment of current diet and amount of gluten consumed will be determined by the dietitian and by means of a questionnaire at baseline. Subjects will have a 2-week run in period, in which they will continue or initiate a gluten free diet plan prepared by the dietitians. After the run-in period, participants will be randomized to either a gluten containing diet (GCD) or placebo (GFD) for 4 weeks.
16108823|NCT02098057|Drug|Placebo|"A total of 24 patients with NCGS and 12 healthy controls will be recruited for this study. The 24 patients with NCGS will be randomized to receive one of two diets (GFD or GCD) in a 1:1 ratio
~Assessment of current diet and amount of gluten consumed will be determined by the dietitian and by means of a questionnaire at baseline. Subjects will have a 2-week run in period, in which they will continue or initiate a gluten free diet plan prepared by the dietitians. After the run-in period, participants will be randomized to either a gluten containing diet (GCD) or placebo (GFD) for 4 weeks."
16108824|NCT02098031|Other|Improving nutrition knowledge among mothers|
16108825|NCT02098018|Behavioral|Program 2|A well-established behavioral method for reducing stress. To maintain blinding, details will be given to participants after randomization.
16108963|NCT02097043|Drug|Placebo|
16108826|NCT02098018|Behavioral|Program 1|A well-established behavioral method for reducing stress. To maintain blinding, details will be given to participants after randomization.
16108827|NCT02098005|Other|usual care evidence-based physiotherapy|Arm 1 (i.e., the control group) will be subjected to a control intervention, including back/neck school and general exercises. 3 sessions of education (session 1: group session; session 2: online module; session 3: individual session) will be given by a physiotherapist, followed by 15 sessions of traditional physiotherapy and general exercises. The 18 sessions will be spread over a period of 3 months.
16108828|NCT02098005|Other|modern neuroscience approach|Arm 2 (i.e., the experimental group) will receive pain neuroscience education (3 sessions of education), followed by 15 sessions of cognition-targeted motor control training (15 sessions). The 18 sessions will be spread over a period of 3 months.
16108829|NCT02097992|Drug|Roflumilast Placebo|Placebo pill
16108830|NCT02097992|Drug|Roflumilast|500 Ug ORAL TABLET
16108831|NCT02097979|Behavioral|Glaucoma Educational Intervention|
16108832|NCT02097966|Drug|Daclatasvir|
16108833|NCT02097966|Drug|Sofosbuvir|
16108834|NCT02097966|Drug|Ribavirin|
16108835|NCT02097953|Drug|Daptomycin|
16108836|NCT02097953|Drug|Rifampin|
16108837|NCT02097940|Other|proprioceptive exercises|Exercises with movements, jumping and imbalance.
16108838|NCT02097927|Behavioral|Mango-flavour beverage|The study will be a 3-way crossover design: it will assess the impact of a high-energy, sensory-enhanced beverage on energy intake through ad libitum food consumption and subjective feeling of appetite using visual analogue scales (VAS) compared to 2 control beverages following repeated exposures. Each participant will consume each beverage 10 times. This includes 2 satiety-testing sessions on site at Leatherhead Food Research, and 8 occasions consuming the product as a mid-morning snack during the participants' normal routine. Each participant will attend the Nutrition Unit on 6 different occasions before and after repeated exposures to the beverages at home. There will be a two-week washout period in which none of the beverages are consumed between the different beverage manipulations.
16108839|NCT02097914|Behavioral|Educational print materials and coaching call|Intervention group participants receive three sets of mailed educational materials about making their home smoke-free and one coaching call.
16108840|NCT02097901|Procedure|Microfracture|Rotator Cuff Repair AND Microfracture
16108841|NCT02097901|Procedure|NO microfracture|Rotator Cuff Repair without microfracture
16108842|NCT02097875|Drug|BLZ-100|
16108843|NCT02097862|Procedure|Adipose Stem Cells|Injection of adipose derived stem cells intra-discally
16108844|NCT02097849|Drug|dimethyl fumarate|Throughout the study participants will remain on their existing, stable dosing regimen of Tecfidera.
16108845|NCT02097849|Biological|tetanus diphtheria toxoids vaccine|Administered as described in the treatment arm
16108846|NCT02097849|Biological|23-valent pneumococcal polysaccharide vaccine|Administered as described in the treatment arm
16108847|NCT02097849|Biological|meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent)|Administered as described in the treatment arm
16108848|NCT02097849|Drug|non-pegylated interferon|Throughout the study participants will remain on their existing, stable dosing regimen of non-pegylated IFN.
16108849|NCT02097836|Device|Targeted Training|Custom training devices were imported from The Movement Centre for research purposes. The typical course of treatment involves loaning the customized equipment to each family for use in their home or in their child's educational setting. Training occurs once daily usually for 30-45 minutes. This is done 5 or 6 days per week. Training programs typically involve playing with balls or balloons or video games that motivate the child to hold the head erect and to wave the arms and hands and move the upper body.
16108850|NCT02097823|Drug|Olanzapine|
16108851|NCT02097823|Drug|Aprepitant|
16108852|NCT02097810|Drug|Entrectinib|
16108853|NCT02097797|Other|Fecal Transplantation|Fecal microbiota (50-100g of stool from donor resuspended in 250-350ml of physiological serum and filtered) given by infusion in coecum during colonoscopy
16108854|NCT02097797|Other|Sham Transplantation|250-350ml of physiological serum given by infusion in coecum during colonoscopy
16108855|NCT02097784|Procedure|Echocardiography|
16108856|NCT02097771|Device|LMA SupremeTM|
16108857|NCT02097771|Device|AuraOnceTM|
16108858|NCT02097758|Device|Transcatheter device closure|"Closure of atrial septal defect with device
~choosing device size with 3D image and the formula
~we do not use sizing balloon for choosing of the device size"
16108859|NCT02097745|Drug|methotrexate|a 10-25 mg stable dose given orally or parenterally throughout study
16108860|NCT02097745|Drug|rituximab [MabThera/Rituxan]|1 g given by intravenous infusion on Days 1 and 15 of each treatment course
16108861|NCT02097732|Drug|Ipilimumab|Ipilimumab 3mg/kg given intravenously over 90 minutes, every 3 weeks for a total of 4 doses.
16108862|NCT02097732|Procedure|Stereotactic Radiosurgery|Stereotactic radiosurgery is a type of focused radiation therapy. It requires the placement of a metal frame on the head for several hours.
16108863|NCT02097719|Drug|bimatoprost 0.01%|Bimatoprost 0.01% administered to both eyes once daily for 12 weeks.
16108864|NCT02097719|Drug|travoprost 0.004%|Travoprost 0.004% administered to both eyes once daily for 12 weeks.
16108865|NCT02097719|Drug|timolol 0.5%|Timolol 0.5% administered to both eyes once daily for 12 weeks.
16108866|NCT02097719|Drug|hypromellose 0.3%|Hypromellose 0.3% lubricant eye drops (for masking purposes) administered to both eyes once daily for 12 weeks.
16108867|NCT02097706|Drug|NMDA receptor antagonist (active drug)|
16108868|NCT02097706|Other|Lactose packed capsule (inert/inactive arm)|
16108869|NCT02097680|Drug|Letrozole|One Letrozole 2.5 mg capsule every two days during four months
16108870|NCT02097680|Drug|Placebo|One placebo capsule every two days during four months
16108871|NCT02097654|Other|SENATOR software generated pharmacotherapy advice report.|
16108872|NCT02097641|Biological|Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells|Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells was administered intravenously over approximately 60-80 minutes.
16108873|NCT02097641|Biological|Plasma-Lyte A|Plasma-Lyte A placebo was administered intravenously over approximately 60-80 minutes.
16108874|NCT02097628|Procedure|tidal volume|In the volume controlled ventilation group using laryngeal mask airway Guardian,a tidal volume of 8-12ml/kg,respiratory rate12-16bpm.
16108875|NCT02097628|Procedure|peak airway pressure|In the pressure controlled ventilation group using laryngeal mask airway Guardian,a peak airway pressure that provides a tidal volume of 8-12ml/kg with an upper limit of 35 centimeter water column,respiratory rate12-16bpm.
16108876|NCT02097615|Procedure|chlorhexidine gluconate|chlorhexidine gluconate spray of 0.125% . Application in the area of the ulcer every 24 hours for six weeks
16108877|NCT02097615|Other|deionized water|application every 24 hours six weeks
16108878|NCT02097589|Drug|Atorvastatin|10-person arm receiving treatment for 28 days: 40 mg atorvastatin, taken orally, once daily, for 28 days.
16108879|NCT02097589|Drug|Pneumovax 23|Pneumovax 23 injected once, intramuscularly at Day 7.
16108880|NCT02097589|Other|Placebo (lactose pill)|10-person arm receiving treatment for 28 days: Placebo (lactose pill), taken orally, once daily for 28 days.
16108881|NCT02097576|Other|Saline mixed with Manuka Honey|Saline mixed with MH nasal rinses participants will be instructed how to mix a rounded teaspoon of MH (Wedderspoon® 100% Raw Manuka Honey Active 16+) with 4-6 oz of lukewarm distilled or previously boiled water, to add along with distilled or previously boiled water and the NeilMed® Sinus Rinse packet to the rinse bottle to a final volume of 240 ml. Participants will be instructed to rinse slowly with the MH/saline rinse mixture to maximize contact time with the MH/saline mixture.
16108882|NCT02097576|Other|NeilMed Saline Sinus Rinse|Saline nasal rinses will be performed using a NeilMed® Sinus Rinse 240 ml bottle and one NeilMed® packet containing sodium chloride/sodium bicarbonate at a concentration to make an isotonic solution when mixed with distilled or previously boiled water.
16108883|NCT02097563|Behavioral|High Intensity Training|This is a training method involving a live workshop followed by high intensity technical consultation.
16108884|NCT02097563|Behavioral|Low Intensity Training|Clinicians complete an online workshop in family-focused therapy, followed by technical consultation sessions after every third session.
16108885|NCT02097550|Other|eHealth Intervention|Patients randomized to this arm will receive eHealth materials every 2-4 weeks over the 12-month intervention. However, the exact nature of timing, dose, and delivery channel will be informed by the formative research.
16108886|NCT02097537|Drug|Methacholine Chloride (SK-1211)|
16108887|NCT02097524|Drug|Sarilumab|
16108888|NCT02097524|Drug|Tocilizumab|
16108889|NCT02097511|Drug|Sarpogrelate pretreatment|Sarpogrelate hydrochloride 100 mg pretreatment three times a day for three days
16108890|NCT02097511|Drug|Sarpogrelate|Sarpogrelate hydrochloride 100 mg three times a day
16108891|NCT02097511|Drug|Metoprolol|Metoprolol Tartrate 100 mg once a day
16108892|NCT02097498|Other|Directed feedback|Group will receive feedback from an airway management expert while the paramedic review their baseline simulation scenario through recorded video
16108893|NCT02097498|Other|Basic Videolaryngoscopy Videos|Group will watch a series of educational videos related to common airway management errors.
16108894|NCT02097485|Drug|Abametapir Lotion 0.74% w/w|200mL abametapir lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water.
16108895|NCT02097485|Drug|Vehicle Lotion|control to abametapir: 200mL Vehicle Lotion topically administered to the scalp and hair and once fully saturated left for 10 minutes and then washed out thoroughly with warm water.
16108896|NCT02097472|Biological|PATH-wSP|Streptococcus pneumoniae Whole Cell Vaccine adsorbed to Alum
16108897|NCT02097472|Biological|Synflorix|"1 dose (0.5 mL) contains:
~1 μg of each of the following pneumococcal polysaccharide serotypes:
~1, 5, 6B, 7F, 9V, 14, and 23 F
~And 3 μg of the following pneumococcal polysaccharide serotypes:
~4, 18C and 19F.
~The serotypes are conjugated to either:
~protein D (derived from Non-Typeable Haemophilus influenzae) carrier protein, tetanus toxoid carrier protein or diphtheria toxoid carrier protein"
16108898|NCT02097472|Biological|Pentavac|"Each PFS contains 0.5 ml (single dose):
~Diphtheria Toxoid 20 Lf to 30 Lf Tetanus Toxoid 2.5 Lf to 10 Lf B. Pertussis 4 IU HBsAg (rDNA) 10 mcg Purified capsular HIB Polysaccharide (PRP) Conjugated to Tetanus Toxoid (carrier protein) 10 mcg Adsorbed on Aluminium Phosphate, AL+++ 1.25 mg Preservative: Thiomersal 0.005 % Dose: O.5ml by intramuscular injection."
16108899|NCT02097472|Other|Saline|0.9% Sodium Chloride Injection, USP
16108900|NCT02097459|Drug|Anastrozole|
16108901|NCT02097459|Drug|Tamoxifen|
16108902|NCT02097459|Drug|Toremifene|
16108903|NCT02097446|Device|Guardix-FL|
16108904|NCT02097446|Device|Interceed|
16108905|NCT02097433|Drug|Dacomitinib|A single 45 mg oral dose of Dacomitinib will be administered under fasted conditions to healthy Chinese volunteers
16108906|NCT02097420|Device|Mitral valve replacement SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve|Implantation of the SJM™ Masters HP™ 15mm Rotatable Mechanical Heart Valve in the mitral and aortic positions
16108907|NCT02097407|Drug|Group C : Saline + propofol group|"All patients were pre-oxygenated with 100% oxygen with spontaneous breathing for 3 min before the end of loading of normal saline. Anaesthesia was induced with predetermined effect-site propofol concentrations using a target-controlled infusion device (Orchestra; Fresenius-Vial, Brezins, France). The first patient in Group C received an effect-site propofol concentration of 3 and 5 µg mL-1, respectively, over 5 min.
~After equilibration of the plasma and effect-site propofol concentrations, i-gel (size 4 for patients weighing 50-90 kg, size 3 for patients weighing 30-50 kg) was inserted using the standard technique by a single anaesthesiologist staff member with expertise in i-gel insertion and who entered the operating room immediately before i-gel insertion to blind him to the group assignment"
16108908|NCT02097407|Drug|Group D : Dexmedetomidine + propofol group|"All patients were pre-oxygenated with 100% oxygen with spontaneous breathing for 3 min before the end of loading of dexmedetomidine. Anaesthesia was induced with predetermined effect-site propofol concentrations using a target-controlled infusion device (Orchestra; Fresenius-Vial, Brezins, France). The first patient in Group D received an effect-site propofol concentration of 3 and 5 µg mL-1, respectively, over 5 min.
~After equilibration of the plasma and effect-site propofol concentrations, i-gel (size 4 for patients weighing 50-90 kg, size 3 for patients weighing 30-50 kg) was inserted using the standard technique by a single anaesthesiologist staff member with expertise in i-gel insertion and who entered the operating room immediately before i-gel insertion to blind him to the group assignment."
16108909|NCT02097394|Drug|Combizym|Combizym( 1 tablet, po, tid)
16108910|NCT02097394|Drug|Bifidobacteri|Bifidobacteri (2 tablet, po, tid)
16108911|NCT02097394|Drug|Combizym + Bifidobacteri|Combizym( 1 tablet, po, tid) + Bifidobacteri (2 tablet, po, tid)
16108912|NCT02097381|Drug|Tenofovir-Emtricitabine plus Lopinavir/Ritonavir or Darunavir/Ritonavir|"Conventional antiretroviral therapy started in naïve patients for antiretroviral treatment that met the criteria to start cART according to International Guidelines.
~The antiretroviral treatment consisted in a tenofovir-emtricitabine NRTI backbone (TDF/FTC, 300/200 mg/ml, once a day) plus boosted protease inhibitor, lopinavir/ritonavir (LPV/r, 400/100 mg twice a day) or darunavir/ritonavir (DRV/r 800/100mg once a day)."
16108913|NCT02097368|Procedure|tongue strength measurement|tongue strength measurement
16108914|NCT02097368|Procedure|respiratory function measurement|respiratory function measurement
16108915|NCT02097368|Procedure|swallowing tests|swallowing tests
16108916|NCT02097368|Other|Magnetic resonance imaging|Magnetic resonance imaging
16108917|NCT02097355|Other|TriVox for clinical care|Use TriVox disease modules to manage patients
16108918|NCT02097342|Drug|Linagliptin|Tablet Linagliptin (5mg) per oral, once daily will be given to 10 patients for 6 months
16108919|NCT02097342|Drug|Placebo|Tablet placebo per oral, once daily will be given to 10 patients for 6 months
16108920|NCT02097342|Drug|Voglibose|Tablet Voglibose (0.2mg) per oral thrice daily(with meals) to 10 patients for 6 months
16108921|NCT02097329|Drug|palbociclib commercial free base|125 mg oral capsule single dose
16108922|NCT02097329|Drug|famotidine|20 mg oral tablet 10 hours before and 2 hours after palbociclib
16108923|NCT02097329|Drug|rabeprazole|2 x 20 mg oral tablets daily for 6 days then on 7th day, 4 hours after palbociclib
16108924|NCT02097329|Drug|palbociclib commercial free base|125 mg oral capsule single dose
16108925|NCT02097329|Drug|antacid|30 mL orally once (2h before palbociclib)
16108926|NCT02097329|Drug|antacid|30 mL orally once (2h after palbociclib)
16108927|NCT02097316|Device|JewelPump|
16108928|NCT02097316|Device|usual insulin pump|
16108929|NCT02097303|Drug|Concurrent use of Radium Ra 223 dichloride and Abiraterone Acetate plus Prednisone|Radium Ra 223 dichloride - A targeted alpha particle-emitting pharmaceutical (a radiopharmaceutical drug) is a ready-to-use solution for intravenous injection containing the drug substance radium dichloride. The active moiety is the alpha particle emitting nuclide Ra-223, present as a divalent cation (223Ra2+) and Abiraterone Acetate - A CYP17 inhibitor, indicated in combination with prednisone for the treatment of subjects with metastatic castration-resistant prostate cancer. Administration of Abiraterone Acetate may result in mineralocorticoid-related adverse events (AEs), due to CYP17 inhibition. Therefore, Abiraterone Acetate is administered in combination with Prednisone to reduce the frequency of these AEs.
16108930|NCT02097290|Device|CRT-D|For all subjects with the AUTOGEN CRT-D, the autothreshold algorithms will be evaluated
16108931|NCT02097277|Biological|BMS-986036|
16108932|NCT02097277|Biological|Placebo (Matching with BMS-986036)|
16108933|NCT02097264|Drug|NNC0109-0012|Solution for injection administered subcutaneously (s.c. - under the skin). 240 mg NNC0109-0012 will be administered weekly for 12 weeks
16108934|NCT02097264|Drug|Adalimumab|Solution for injection administered subcutaneously (s.c. - under the skin). Administered every other week for 12 weeks; Each active treatment involves 1 (one) s.c. injection of adalimumab 40 mg/0,8 mL solution for injection for paediatric use (Humira®)
16108935|NCT02097264|Drug|placebo|"Solution for injection administered subcutaneously (s.c. - under the skin).
~1 active adalimumab injection and 2 placebo injections per active treatment (every other week), and 3 placebo injections on placebo visits (alternative weeks)."
16108936|NCT02097251|Drug|UX003|Open Label
16108937|NCT02097238|Drug|Eribulin Mesylate|Given IV
16108938|NCT02097238|Other|Pharmacological Study|Correlative studies
16108939|NCT02097225|Drug|Dabrafenib|Given PO
16108940|NCT02097225|Other|Laboratory Biomarker Analysis|Correlative studies
16108941|NCT02097225|Drug|Onalespib|Given IV
16108942|NCT02097225|Other|Pharmacological Study|Correlative studies
16108943|NCT02097225|Drug|Trametinib|Given PO
16108944|NCT02097199|Other|Increased sports workload|"At least 150 minutes of moderate or 75 minutes of vigorous exercise per week. The Recommendations for Adults From the American College of Sports Medicine and the American Heart Association clearly define physical exercise intensity levels. The present study follows these recommendations. Consequently, moderate physical activity can be reached by e.g. quick walking, slow bicycling, slow swimming...; it is also possible to reach the expected workload by engaging in vigorous exercise (e.g. jogging/running, quick swimming, playing soccer/tennis...). The gain in performance will objectified by performing a bicycle stress test at the beginning and the end of the study."
16108945|NCT02097186|Procedure|Remote ischaemic preconditioning|Ischaemic preconditioning is a phenomenon whereby a brief period of non-lethal ischaemia in a tissue renders it resistant to the effects of a subsequent much longer ischaemic insult. Remote ischaemic preconditioning works on the theory that brief ischaemia in one tissue could confer protection on distant organs.
16108946|NCT02097173|Drug|Methotrexate|
16108947|NCT02097160|Other|Vitamin D fortified yogurt and cheese products|
16108948|NCT02097160|Other|Control Group 1|
16108949|NCT02097147|Drug|Vilazodone 20 mg|Oral administration, once per day.
16108950|NCT02097147|Drug|Vilazodone 40 mg|Oral administration, once per day.
16108951|NCT02097147|Drug|Paroxetine 20 mg|Oral administration, once per day.
16108952|NCT02097147|Drug|Placebo|Oral administration, once per day.
16108953|NCT02097134|Drug|Melphalan|Given IA
16108954|NCT02097121|Biological|OnabotulinumtoxinA|OnabotulinumtoxinA injected into the detrusor wall on Day 1. Treatments are readministered as needed with a minimum 12 week interval between doses.
16108955|NCT02097108|Drug|Raltegravir|
16108956|NCT02097082|Device|STANZA Drug-eluting resorbable Scaffold|
16108957|NCT02097069|Dietary Supplement|Folic acid|Folic acid 400 mcg/day
16108958|NCT02097069|Dietary Supplement|Myo-inositol|myo-inositol 2000 mg twice a day
16108959|NCT02097069|Dietary Supplement|D-Chiro-inositol|D-chiro inositol 250 mg twice a day
16108960|NCT02097069|Dietary Supplement|Myo-inositol plus D-chiro inositol|Myo-inositol plus D-chiro inositol 550mg/13,8 mg twice a day
16108961|NCT02097056|Drug|Donepezil HCL|Donepezil HCl 23 mg once daily, just before bed, for 24 weeks
16108962|NCT02097043|Drug|DA-7218|
16108964|NCT02097030|Device|filcon II 3|Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.
16108965|NCT02097030|Device|etafilcon A|Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.
16108966|NCT02097030|Device|nelfilcon A|Participants wear a first pair of lenses for three days and then crossover and wear a second pair of lenses for three days.
16108967|NCT02097017|Drug|Lidocaine|will local application of lidocaine to the cervix alleviate pain of laminaria insertion
16108968|NCT02097017|Other|placebo comparator|
16108969|NCT02097004|Biological|Peginterferon alfa-2a|once weekly 180 μg subcutaneous injection for 48 weeks
16108970|NCT02097004|Biological|HBV vaccination|1.0 mL (20 μg) intramuscular injection at 4, 8, 12 and 28 weeks
16108971|NCT02097004|Drug|Entecavir|Continue Entecavir(0.5mg) for 100 weeks
16108972|NCT02096991|Other|Can 1|drink the beverage in a can and a glass bottle
16108973|NCT02096991|Other|Can 2|Consume two canned beverage
16108974|NCT02096991|Other|Glass|consume two glass bottled beverage
16108975|NCT02096978|Procedure|Preparing the osteotomy to accept a standard implant device|Preparing the osteotomy with one of two randomly assigned protocols
16108976|NCT02096965|Drug|Tolvaptan|Patients will receive daily dose of 45 mg (30 mg at 8 AM and 15 mg at 4 PM).
16108977|NCT02096965|Drug|Placebo|Patients will receive daily dose at 8 AM and at 4 PM.
16108978|NCT02096952|Drug|Methylphenidate extended-release liquid formulation|
16108979|NCT02096939|Procedure|Adrenal extirpation|
16108980|NCT02096939|Drug|Antihypertensive medication|
16108981|NCT02096926|Drug|Placebo|
16108982|NCT02096926|Drug|Ibuprofen|400 mg PO
16108983|NCT02096913|Drug|Dolormin® extra (Ibuprofen)|"Ibuprofen Tablets (as lysine-salt) 2400mg/d (400mg 2-2-2) applied orally for 4 weeks (Arm I; n=6).
~In order to reduce the risk of damage to the gastrointestinal mucosa Pantoprazole is applied as concomitant medication in a dosage 40mg/d during the treatment period."
16108984|NCT02096913|Drug|Dolormin® extra (Ibuprofen)|"Ibuprofen Tablets (as lysine-salt) 2400mg/d (400mg 2-2-2) applied orally for 12 weeks (Arm II, n=6).
~In order to reduce the risk of damage to the gastrointestinal mucosa Pantoprazole is applied as concomitant medication in a dosage 40mg/d during the first 4 weeks of treatment and may be reduced to 20mg/d during the following treatment period after individual risk-benefit assessment."
16108985|NCT02096900|Drug|zolpidem|Zolpidem will be given one time at 0.25 mg/kg pre-operatively
16108986|NCT02096900|Drug|Midazolam|
16108987|NCT02096887|Behavioral|Patient Education|"Patient Education using the following two instruments:
~Framingham Risk Score calculator:
~Know your numbers patient booklet"
16108988|NCT02096874|Drug|Bevacizumab|Intravitreal injection of 1.25mg/0.05 cc each 5 weeks for the first 3 months then PRN for six month
16108989|NCT02096861|Biological|CT-P13|CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
16108990|NCT02096861|Biological|Remicade|Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
16108991|NCT02096835|Device|Transcutaneous electrical acupoint stimulation|A surface electrode will be applied to the P6 acupoint on the dominant upper extremity, located approximately 3cm proximal to the distal wrist crease between the tendons of the flexor carpi radialis and the palmaris longus, and a negative surface electrode placed on the opposing dorsum aspect of the forearm.
16108992|NCT02096835|Device|Sham transcutaneous electrical acupoint stimulation|The same TEAS protocol will be applied unless silicone covers will be attached to both electrodes. The device will also be turned on during the procedure.
16108993|NCT02096835|Drug|Tropisetron|will be given at the start of skin closure
16108994|NCT02096835|Drug|Dexamethasone|will be given after induction
16108995|NCT02096822|Behavioral|Facilitated tucking + non-nutritive sucking|
16108996|NCT02096822|Other|non-nutritive sucking|
16108997|NCT02096809|Procedure|One week loading of Bone Anchored Hearing Aid (BAHA)|Patients in this arm will be fitted with the BAHA one week after surgery.
16108998|NCT02096809|Device|Cochlear Baha BI300/BA400 Implant System|
16108999|NCT02096783|Other|informational intervention|Given scripted intervention
16109000|NCT02096783|Other|counseling intervention|Given standard counseling
16109001|NCT02096783|Other|questionnaire administration|Ancillary studies
16109002|NCT02096757|Dietary Supplement|Pro-Omega|Pro-Omega (Nordic Naturals, Watsonville, CA, USA). Each ProOmega capsule contains 325mg of EPA and 225mg of DHA. 4.4gm/day 2 weeks prior to surgery and continued for 4 weeks after
16109003|NCT02096757|Other|Pro-Omega Placebo|Placebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA); 4.4gm/day 2 weeks prior to surgery and continued for 4 weeks after
16109004|NCT02096744|Drug|Catapres-TTS-1|Catapres-TTS-1 Oppanol
16109005|NCT02096744|Drug|Intervention 1: Catapres-TTS-3|Catapres-TTS-3 Oppanol
16109006|NCT02096744|Drug|Intervention 1: Catapres-TTS-3|Catapres-TTS-3 Oppanol
16109007|NCT02096744|Drug|Intervention 2: Catapres-TTS-3|Catapres-TTS-3 Vistanex
16109008|NCT02096744|Drug|Catapres-TTS-1|Catapres-TTS-1 Vistanex
16109009|NCT02096744|Drug|Intervention 2: Catapres-TTS-3|Catapres-TTS-3 Vistanex
16109010|NCT02096718|Drug|Afatinib healthy|
16109011|NCT02096718|Drug|Afatinib severe renally impaired|
16109012|NCT02096718|Drug|Afatinib moderate renally impaired|
16109013|NCT02096705|Drug|Dapagliflozin|Tablet
16109014|NCT02096705|Drug|Dapagliflozin Placebo|Tablet
16109015|NCT02096692|Device|Patients with a ProMRI ICD System|Tachycardia Fast Heart Beat
16109016|NCT02096692|Other|Magnetic Resonance Imaging (MRI) scan|MRI scan of heart/chest or thoracic spine
16109017|NCT02096679|Drug|AZD9291|Volunteer will receive a single oral dose of 20 mg [14C]-AZD9291 as a solution on Day 1
16109018|NCT02096666|Drug|AMG 337|Phase 1- AMG 337 150 mg, 200mg and 300 mg orally daily. Additional 150 mg and 200 mg orally twice daily. Phase 2- AMG 337 (dose determined by Phase 1)
16109019|NCT02096653|Procedure|X-ray SI joint steroid injection|Injection of steroid and local anesthetic into the joint cavity using fluoroscopic guidance
16109150|NCT02095626|Drug|AP-301|orally delivered doses of 87.6 mg AP301 (dose per subject, 5 ml nebulizer filling dose) are inhaled every 12 hours for a total of 7 days
16109020|NCT02096653|Procedure|Landmark-guided SI steroid injection|Injection of steroid into the joint area based on palpation. The injection may be inside the joint (intra-articular) or outside the joint in the ligaments (extra-articular)
16109021|NCT02096640|Procedure|Type of surgical teqnique for tracheostomy|
16109022|NCT02096614|Drug|TBI-1201|TBI-1201(5*10^8 or 5*10^9) is administered.
16109023|NCT02096614|Drug|Cyclophosphamide|Cyclophosphamide (750mg/m2/day x 2 days Intravenous (IV)) is administered as pre-treatment medication of TBI-1201
16109024|NCT02096614|Drug|Fludarabine|Fludarabine (20mg/m2 x 5 days Intravenous(IV)) is administered as pre-treatment medication of TBI-1201 in combination with cyclophosphamide.
16109025|NCT02096601|Drug|Levodopa and carbidopa SC solution|Levodopa and carbidopa SC solution
16109026|NCT02096601|Drug|Oral levodopa and carbidopa|Oral levodopa and carbidopa
16109027|NCT02096588|Drug|Simvastatin|Simvastatin will be administered on an outpatient basis orally at a dose of 40 mg once daily.
16109028|NCT02096588|Drug|Doxorubicin/cyclophosphamide|The standard chemotherapy regimen that must be planned for all participants in order to take part in this study. The regimen is given every 2 or 3 weeks per standard of care, at the direction of the treating physician.
16109029|NCT02096575|Other|Nitrous oxide administration|"All participants will receive 800 mg of oral ibuprofen 30 minutes pre-operatively. The NO group will get two placebo pills and the standard care group will get one 5/325 mg Vicodin, and 1 mg of Ativan 30 minutes before the procedure. The standard care group will get oxygen intraoperatively.
~NO or oxygen will be administered via a scented nasal mask to blind patients to the intervention.
~All patients will get local anesthesia via a standardized PCB."
16109030|NCT02096562|Other|Patients use compression stockings for 10 days after surgery|patients wear compression stocking for 24 hours in the first 2 days after surgery and for at least 8 hours at day 3-10 after surgery
16109031|NCT02096562|Other|normal therapy - no compression stockings|the patients receive the common therapy according to S2 guidelines
16109032|NCT02096536|Drug|Vancomycin|vancomycin administration based on decision of treating physician
16109033|NCT02096523|Other|Blood collection for platelet protein samples|
16109034|NCT02096510|Drug|Solu-Cortef|administration by pump for minimum 2 weeks
16109035|NCT02096510|Drug|Cortef|tablet treatment 2 ro 3 times per day for 14 days
16109036|NCT02096484|Behavioral|Group Metacognitive Therapy|
16109037|NCT02096484|Behavioral|Mindfulness Meditation Therapy|
16109038|NCT02096471|Drug|PD-0325901|
16109039|NCT02096458|Drug|Dexlansoprazole|Dexlansoprazole delayed-release orally disintegrating tablets
16109040|NCT02096445|Device|robot-assisted neurocognitive therapy of hand function|2 degrees-of-freedom hand rehabilitation robot to train fine motor skills during grasping and forearm rotation.
16109041|NCT02096445|Other|Conventional neurocognitive rehabilitation|Use sensory perception (tactile, proprioception but not vision!) to solve a by the therapist guided (passive) or patient controlled (active) therapy task, e.g. discrimination/identification of different spring resistances, sponges, different sized blocks, etc.
16109042|NCT02096432|Behavioral|Behavior Activation|Behavioral Activation includes the following components: empowering education, referral to treatment, care Management, and behavior activation
16109043|NCT02096432|Behavioral|Usual Community Care|Community standard care as usual
16109044|NCT02096419|Drug|Clopidogrel dose adjustment|"Patients in the interventional arm will receive clopidogrel dose adjustment to maintain optimal platelet reactivity determined by Multiplate function analyzer (19-46U).
~They will undergo platelet function testing on day 1,2,3,7,30 and month 2,3,6,9 and 12.
~On first two measurements patients will receive up to 2 additional clopidogrel loading doses (600 mg) and put on 150 mg and 75 mg a day if platelet reactivity >18U and <18U, respectively. Maintenance dose will be determined on following measurements - increased by 75 mg if >46U; not changed if 19-46U; decreased by 75 mg if <19U. Minimal dose - 75 mg; maximal dose 300 mg (for patients >70 years 150 mg)"
16109045|NCT02096406|Drug|ACE/ARB continuation|ACE/ARB will be taken the morning of surgery with a sip of water
16109046|NCT02096406|Drug|ACE/ARB withdrawal|ACE/ARB will be stopped 48 hours prior to surgery
16109047|NCT02096393|Device|Zimmer Patient specific instruments|A custom made cutting block will be used during total knee replacement surgery. The cutting block is made specific to patient's anatomy based on MRI scans taken 6 weeks prior to surgery.
16109048|NCT02096393|Device|Standard instrumentation|Standard instrumentation will be used during total knee replacement surgery.
16109049|NCT02096380|Drug|One cycle TPF induction chemotherapy for NPC|"One cycle TPF induction chemotherapy for NPC
~Patients receive docetaxel (60mg/m2 on day 1), cisplatin (20mg/m2 on day 1-4) and fluorouracil (800mg/m2/d, continuous infusion, d1-4) every three weeks for single one cycle before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30mg/m2) every week for six cycles during radiotherapy.
~A total dose of 70Gy in 30 fraction to PTV-P, 60Gy in 30 fraction to PTV-1 and 54Gy in 30 fraction to PTV-2."
16109050|NCT02096380|Drug|Three cycles TPF induction chemotherapy for NPC|"Three cycles TPF induction chemotherapy for NPC
~Patients receive docetaxel (60mg/m2 on day 1), cisplatin (20mg/m2 on day 1-4) and fluorouracil (800mg/m2/d, continuous infusion, d1-4) every three weeks for three cycles before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30mg/m2) every week for six cycles during radiotherapy.
~A total dose of 70Gy in 30 fraction to PTV-P, 60Gy in 30 fraction to PTV-1 and 54Gy in 30 fraction to PTV-2."
16109051|NCT02096367|Other|Gait analysis|
16109052|NCT02096367|Other|Kinematic gait analysis in lower limb|
16109053|NCT02096367|Other|Analysis of static posture|
16109054|NCT02096367|Other|Gait on treadmill|Treadmill during 2 minutes
16109055|NCT02096367|Device|Muscle vibration stimulation|Vibration stimulation at a 70 Hz frequency of biceps brachii muscle (sham), posterior neck muscles and gluteus medius muscle on the hemiplegic side
16109056|NCT02096354|Drug|RRx-001|
16109057|NCT02096354|Drug|Regorafenib|
16109058|NCT02096354|Drug|Irinotecan|To be dosed after RRx-001 or regorafenib
16109059|NCT02096341|Drug|RRx-001|"RRx-001 Dose level 1 (16 mg/m2) twice weekly
~RRx-001 Dose level 2 (27 mg/m2) twice weekly"
16109060|NCT02096328|Drug|POL7080|Intravenous infusion
16109061|NCT02096315|Drug|POL7080|Intravenous infusion
16109471|NCT02093195|Drug|Symbicort turbuhaler|
16110653|NCT02084056|Drug|Linagliptin|Linagliptin
16109062|NCT02096302|Dietary Supplement|Infant Formula with a novel probiotic CECT7210|Bottle-feeding with a new infant formula enriched with probiotic CECT7210 during the first 3 months of life.
16109063|NCT02096302|Dietary Supplement|Standard formula|Standard formula without probiotics
16109064|NCT02096289|Drug|Thioridazine|
16109065|NCT02096276|Other|Data collection|Initial and follow-up data will be collected using questionnaires.
16109066|NCT02096263|Biological|Infanrix hexa|3 doses administered intramuscularly in the right thigh.
16109067|NCT02096263|Biological|Pediarix|3 doses administered intramuscularly in the right thigh
16109068|NCT02096263|Biological|ActHIB|4 doses administered intramuscularly in the upper left thigh
16109069|NCT02096263|Biological|Pentacel|4 doses administered intramuscularly in the right thigh
16109070|NCT02096263|Biological|Engerix-B|2 or 3 doses administered intramuscularly in the upper left thigh
16109071|NCT02096263|Biological|Infanrix|1 dose administered intramuscularly in the right thigh
16109072|NCT02096263|Biological|Hiberix|1 dose administered intramuscularly in the left thigh
16109073|NCT02096263|Biological|Prevnar13|3 doses administered intramuscularly in the lower left thigh
16109074|NCT02096263|Biological|Rotarix|2 doses administered orally
16109075|NCT02096250|Other|NaFeEDTA|
16109076|NCT02096250|Other|Ferrous fumarate|
16109077|NCT02096250|Other|NaFeEDTA + ferrous fumarate|
16109078|NCT02096237|Device|IgE adsorber|Two plasma volumes of each patient in the apheresis group will be treated per session
16109079|NCT02096224|Drug|Sevoflurane|Sevoflurane will be used.
16109080|NCT02096224|Drug|Desflurane|Desflurane will be used
16109081|NCT02096211|Device|COC 36mm|Total Hip Replacement with COC 36mm Acetabular Cup System
16109082|NCT02096185|Radiation|3 dimensional tomosynthesis imaging|Each operative specimen will be imaged twice using each condition
16109083|NCT02096185|Radiation|2 dimensional digital imaging|
16109084|NCT02096159|Drug|trimethoprim-sulfamethoxazole|
16109085|NCT02096159|Other|placebo|
16109086|NCT02096146|Procedure|TMT Fusion plate|Patients are treated with TMT Fusion Plate a post-market device to encourage bony fusion of the 1st TMT joint.
16109087|NCT02096146|Procedure|Two crossed screws|Patients are treated with two crossed screws.This procedure is a standard treatment for 1st TMT joint fusion.
16109088|NCT02096133|Drug|Cholecalciferol|Vitamin D3 solution
16109089|NCT02096133|Other|Placebo comparator|Placebo comparator
16109090|NCT02096107|Drug|Everolimus|Convert mycophenolate to everolimus with subsequent reduction in exposure to tacrolimus
16109091|NCT02096107|Other|Standard of Care|Tacrolimus, mycophenolate mofetil and steroids
16109092|NCT02096094|Procedure|Standardization phase|Prior the principal intervention, each volunteer should complete a standardization phase, which consists in the daily bathing for two weeks with a antiseptic free soap and shampoo. Likewise would avoid chemical showers such as swimming. At the end of this phase a quantification of skin flora will be perform.
16109093|NCT02096094|Procedure|Control bath|Volunteers will be ask to perform full body bath with wipes without impregnation for 3 to 5 days, each day the volunteer will answer a survey regarding side effects (skin reactions) and comfort related to the bath. At the end of the intervention, a skin culture to quantify skin colonization will be performed.
16109094|NCT02096094|Procedure|Bath with chlorhexidine|Volunteers will be asked to perform full body bath with wipes with 2% chlorhexidine impregnation and with 0.15% chlorhexidine shampoo (for the head and genitalia) for 3 to 5 days. Each day the volunteer will answer a survey regarding side effects (skin reactions) and comfort related to the bath. At the end of the intervention, a skin culture to quantify skin colonization will be performed.
16109095|NCT02096081|Drug|IncobotulinumtoxinA|20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection
16109096|NCT02096081|Drug|OnabotulinumtoxinA|20U injection: equal aliquots of 0.1 mL (4U) to 5 injection points; mode of application: intramuscular injection
16109097|NCT02096068|Drug|Dexmedetomidine (Dexdor®)|Dexmedetomidine (Dexdor 100 micrograms/ml concentrate for solution for infusion)
16109098|NCT02096068|Drug|0.9% Sodium Chloride|Solution for infusion: Sodium Chloride : 9.0 g/l; Each ml contains 9 mg sodium chloride mmol/l : Na+ : 154. Cl-: 154.
16109099|NCT02096055|Drug|Cladribine|Given IV
16109100|NCT02096055|Drug|Guadecitabine|Given SC
16109101|NCT02096055|Drug|Idarubicin|Given IV
16109102|NCT02096042|Drug|Brentuximab Vedotin|"Pilot Phase: Starting dose of Brentuximab Vedotin 1.2 mg/kg intravenous (IV) infusion over approximately 30 minutes on days 1, 8, and 15 of each 28-day cycle.
~Phase I Dose-Escalation Phase: Starting dose of Brentuximab Vedotin 1.0 mg/kg IV (starting dose level 1), or one-dose level lower than the established MTD if the pilot portion of the study establishes a lower MTD, infusion over approximately 30 minutes on days 1, 8, and 15 of each 28-day cycle.
~Phase II Dose-Expansion Phase: Patients receive Brentuximab Vedotin at MTD from dose-escalation phase by vein on Days 1, 8, and 15 of each 28-day cycle."
16109103|NCT02096042|Drug|5-Azacytidine|Phase I Dose-Escalation Phase and Phase II Dose-Expansion Phase: 5-Azacytidine at 75 mg/m2/day by vein or subcutaneously on days 1-7 every 28 days.
16109104|NCT02096029|Other|Nicotine Replacement Therapy (NRT) Sampling|2 week supply of 4 mg nicotine lozenge and 14 mg nicotine patch
16109105|NCT02096029|Behavioral|Ask, Advise, Refer (physician brief advice)|
16109106|NCT02096016|Procedure|Human Papilloma Virus test from the vaginal vault|Surveillance after surgical treatment of early stage cervical cancer
16109107|NCT02096003|Drug|Intrathecal morphine|0.25mg intrathecal morphine is the standard opioid medication the investigators use for analgesia for cesarean sections. It is the control arm.
16109108|NCT02096003|Drug|Intrathecal hydromorphone|50mcg intrathecal hydromorphone will be added to 1.5mg 0.75% bupivicaine for single shot spinal anesthesia.
16109109|NCT02095990|Drug|Hydroquinone|
16109110|NCT02095990|Drug|Placebo|
16109111|NCT02095977|Procedure|fluoroscopy|Fluoroscopic evaluation of three different views (left anterior oblique, right anterior oblique and anterior/posterior) and magnification will be performed to check for externalized cables at 15 frames per second using the best visualized angle per screening electrophysiologist.
16109472|NCT02093169|Drug|Part A: Lu AF35700|One 30 mg single dose for one day; orally
16109112|NCT02095977|Procedure|synchronized high-voltage shock|"If fluoroscopic evaluation shows externalized conductors or if patient is deemed high-risk, the patient will be consented for synchronized high voltage shock through his/her device. This will be done in the non-invasive electrophysiology lab with conscious sedation as is done during defibrillation threshold testing.
~For patients undergoing a generator (ICD) change as part of standard of care, performance of synchronized, high-voltage shock will be performed at the discretion of the electrophysiologist."
16109113|NCT02095977|Procedure|Holter monitor|Participants will be given a 24-hour Holter monitor at baseline and once annually, and will be followed at least every three months throughout the study. Participants who are found to have an electrical abnormality at any point during the study may be given a 24-hour Holter monitor if it is believed that this procedure will provide clinically useful information regarding the integrity of the lead.
16109114|NCT02095951|Drug|Ethanol lock therapy (ELT)|Participants will be randomized to receive early (preemptive) ELT (after 12 hours from time blood culture drawn, but before blood culture positive, R/O sepsis) with systemic antimicrobials versus standard ELT (placed in catheter when blood culture is positive for growth of a germ) with systemic antimicrobials.
16109115|NCT02095938|Drug|amisulpride|Amisulpride (Solian) will be orally administered once or twice daily after meal intake for 8 weeks. Patients initially will receive a low dose of amisulpride (200-400mg/day). The dosage may be adjusted to between 400 and 800mg/day according to the clinical decision by treating physician.
16109116|NCT02095899|Drug|Rufinamide|2x200mg up to max 2x800mg a day Titration over 20days
16109117|NCT02095886|Drug|BMS-955176|BMS-955176
16109118|NCT02095873|Dietary Supplement|Glyoxalase 1 (Glo1) inducer|Dietary bioactive
16109119|NCT02095873|Dietary Supplement|Placebo|Mannitol, 108 mg
16109120|NCT02095860|Drug|DCV 3DAA FDC|Fixed Dose Combination of Daclatasvir (DCV), Asunaprevir (ASV) and BMS-791325
16109121|NCT02095847|Procedure|High-Resolution Microendoscopy Imaging|Once the cervix has been dilated, a hysteroscope will be introduced in the uterine cavity to evaluate for presence of tumor. Location and size of tumor documented. White-light images obtained using the HRME camera introduced through the hysteroscope. Once completed; the hysteroscope will be removed and the uterine cavity will be infused with 10 mL of proflavine (an acridine dye) (0.01% Proflavine (10ml)). A resectoscope will then be introduced in the uterine cavity and fluorescent images obtained using the HRME camera.
16109122|NCT02095847|Drug|Proflavine|After hysteroscopy with HRME camera, uterine cavity infused with 10 mL of Proflavine.
16109123|NCT02095834|Drug|Bendamustine Hydrochloride|Given IV
16109124|NCT02095834|Drug|Carfilzomib|Given IV
16109125|NCT02095834|Drug|Dexamethasone|Given PO or IV
16109126|NCT02095834|Other|Laboratory Biomarker Analysis|Correlative studies
16109127|NCT02095808|Procedure|Imaging Biomarkers|Want to see if using 13C-glucose helps in detecting cancer and deciding on a treatment plan.
16109128|NCT02095795|Device|Technological Rehabilitation|The Lokomat (Hocoma, Zurich, Switzerland) is robotic device conformed as an exoskeleton on the lower limbs of the patient. Through active and passive actuators, it realize a proper trajectory with an associated motion profile of the involved limbs. The results are physically guide repetitive, rhythmic, bilateral lower extremity movements in order to simulate a physiological gait cycle.The system uses a dynamic body weight-support system to support the participant above a motorized treadmill synchronized with the Lokomat. Participants were provided verbal encouragement to actively step in conjunction with the movement presented by the Lokomat.
16109129|NCT02095795|Other|Control Rehabilitation|When needed, more than one therapist are employed in the intervention for safety reasons.
16109130|NCT02095782|Drug|Intercalated combination of chemotherapy and erlotinib|"Primary therapy stage:
~Paclitaxel Patients receive six cycles of Paclitaxel (175 mg/m² on days 1 of a 4 week cycle, intravenously) plus carboplatin (AUC=5, intravenously on day 1 of a 4 week cycle, intravenously) with sequential erlotinib (150 mg/day) on days 8-21 of each cycle.
~Maintenance therapy stage:
~Patients, who complete 6 cycles of therapy without progression or intolerable toxicity, receive erlotinib (150 mg/day) as maintenance therapy until progression, intolerable toxicity or death."
16109131|NCT02095756|Other|755nm Alexandrite Laser and Lytera Skin Brightening System (Non-Hydroquinone Topical Therapy)|
16109132|NCT02095756|Other|Lytera Skin Brightening System (Non-hydroquinone topical therapy)|
16109133|NCT02095743|Device|implanted port for chemo administration (X-port isp)|
16109134|NCT02095743|Device|Use of a PICC line for chemo administration (PowerPICC SOLO²)|The description of the device could found on the published marketing authorisation
16109135|NCT02095730|Drug|Epithelium-On Riboflavin|Riboflavin 0.1% Phosphate Sodium solution with Benzalkonium Chloride Preservative
16109136|NCT02095730|Drug|Epithelium-Off Riboflavin|Riboflavin 0.1% Phosphate Sodium solution
16109137|NCT02095730|Device|UV Light - Continuous Beam|5 minutes of constant UV exposure to saturated cornea
16109138|NCT02095730|Device|UV Pulsed Beam|5 minutes of UV exposure to saturated cornea, alternating 1 minute of treatment with 1 minute rest for a total time of 10 minutes
16109139|NCT02095717|Drug|Curcumin|
16109140|NCT02095717|Drug|Placebo|
16109141|NCT02095717|Drug|Taxotere|
16109142|NCT02095704|Drug|paracetamol oral solution|dosage form: paracetamol oral solution;dosage:15.6ml(containing 500 mg of the active ingredient);frequency:single dose
16109143|NCT02095704|Drug|paracetamol tablet|dosage form: paracetamol tablet;dosage: 500 mg;frequency:single dose
16109144|NCT02095691|Device|Celsius® ThermoCool® Renal Denervation|The investigational device is indicated for the treatment of resistant hypertension by renal denervation.
16109145|NCT02095678|Procedure|liver biopsy|patients with HCC or metastatic lesions will have a liver biopsy performed after the experimental MRI. This biopsy will be examined to confirm the imaging results
16109146|NCT02095678|Device|free-breathing MRI|All patients will be asked to come in for an MRI scan using techniques developed which minimize the time a patient has to hold their breath to image the liver to <8 seconds and validate quantifiable techniques which improve liver image quality
16109147|NCT02095665|Drug|Mirabegron|50 mg of Mirabegron daily from stent insertion until removal 5 to 10 days
16109148|NCT02095665|Drug|Tamsulosin|0.4 mg of Tamsulosin daily and 1 tab of Percocet every 4 hours as necessary from stent insertion until removal 5 to 10 days
16109149|NCT02095665|Drug|Tylenol #3|1 tab of Tylenol #3 every 6 hours as necessary from stent insertion until removal 5 to 10 days
16109151|NCT02095626|Drug|saline solution|placebo solution (0.9 % physiologic NaCl, 5 ml nebulizer filling dose) is inhaled every 12 hours for a total of 7 days
16109152|NCT02095613|Other|traditional food|
16109153|NCT02095613|Other|food that is nutrient dense|
16109154|NCT02095600|Radiation|Radiosurgical thalamotomy|
16109155|NCT02095587|Drug|IPI-145|25 mg single oral capsule
16109156|NCT02095574|Drug|[14C]ABT-199 (GDC-0199)|[14C]ABT-199 will be administered as a single oral administration
16109157|NCT02095561|Other|HPV self testing|Community Health Workers instructed women about cervical cancer and HPV testing, advised them on how to seek screening at health centers, and offered them the option of self-testing, providing women with educational materials on how to perform it.
16109158|NCT02095548|Drug|SM04690, 0.03mg/2mL|
16109159|NCT02095548|Drug|SM04690, 0.07mg/2mL|
16109160|NCT02095548|Drug|SM04690, 0.23mg/2mL|
16109161|NCT02095548|Drug|Placebo|
16109162|NCT02095535|Drug|Chlorhexidine gluconate|antiseptic
16109163|NCT02095522|Drug|Colchicine|Colchicine 1mg per day for one month
16109164|NCT02095522|Drug|Placebo|Placebo
16109165|NCT02095509|Drug|Enoxaparin|Drug class: Low-molecular weight heparin
16109166|NCT02095496|Device|Intellivent-ASV|12 hours of mechanical ventilation with intellivent-ASV
16109167|NCT02095496|Device|Conventional ventilation|12 hours of mechanical ventilation with pressure support ventilation
16109168|NCT02095470|Device|video laryngoscope|newly developed innovatory device
16109169|NCT02095470|Device|traditional laryngoscope|traditional way for intubation
16109170|NCT02095457|Behavioral|Frequent monitoring and feedback|In the intervention arm, patients routinely fill short monitoring questionnaires, the results of which are fed back to their therapists and staff. The frequency of monitoring is between once a week to once every three months, depending on the type of therapy
16109171|NCT02095444|Drug|Menstrual blood stem cells|10*7 cells/kg, intravenous injection for 4 times during two weeks
16109172|NCT02095418|Drug|Mycophenolate mofetil, Corticosteroids|tacrolimus (low dose, trough level of 5-12ng/ml)+Mycophenolate mofetil(500-1500mg/day*, bid)+ Basiliximab + corticosteroids 500mg to 5mg or above (2 weeks)
16109173|NCT02095418|Drug|Corticosteroids, Mycophenolate mofetil|tacrolimus (low dose, trough level of 5-12ng/ml)+Mycophenolate mofetil(500-1000mg/day*, bid)+ Basiliximab + corticosteroids 500mg to 5mg or above (3 month±2weeks)
16109174|NCT02095405|Drug|Caffeine|"SVT group: Oral tablets of Caffeine prior to the electrophysiology study in patients with SVT.
~AF group: Dark chocolate and Caffeinated substances in patients with AF at the time of Ambulatory monitoring."
16109175|NCT02095405|Other|Placebo|"SVT group: Oral tablets of placebo prior to the electrophysiology study in patients with SVT.
~AF group: White chocolate and Decaffeinated substances in patients with AF at the time of Ambulatory monitoring."
16109176|NCT02095392|Dietary Supplement|P1000/Ca0|22 subjects consume for 8 weeks a beverage enriched with phosphate [1g phosphorus/d]
16109177|NCT02095392|Dietary Supplement|P1000/Ca500|22 subjects consume for 8 weeks a beverage enriched with phosphate [1 g phosphorus/d] and calcium [0,5 g calcium]
16109178|NCT02095392|Dietary Supplement|P1000/Ca1000|22 subjects consume for 8 weeks a beverage enriched with phosphate [1 g phosphorus/d] and calcium [1 g calcium]
16109179|NCT02095392|Dietary Supplement|Placebo|all participants consume two weeks before intervention the beverage without phosphate and calcium
16109180|NCT02095379|Other|oligosecretary|not abvailable
16109181|NCT02095366|Drug|Morphine|"Intravenous administration Patient receives simultaneously IV morphine administration and IN placebo spray.
~Pain is controlled by:
~at 0 minute : Placebo IN (2 sprays, one spray in each nostril) + morphine IV 0,1mg/kg
~at 10 minutes and if NPRS>3 : Placebo IN (1 spray) + morphine IV 0,05mg/kg
~at 20 minutes and if NPRS>3: Pacebo (1 spray) + morphine IV 0,05mg/kg"
16109182|NCT02095366|Drug|Sufentanil|"Intranasal spray with one spray, equivalent to an half-dose. Patient receives simultaneously IV placebo administration and IN sufentanil spray.
~Pain is controlled by:
~at 0 minute : Sufentanil IN 0,3µg/kg (2 sprays, one spray in each nostril) + NaCl 0,9% IV
~at 10 minutes and if NPRS>3 : Sufentanil IN 0,15µg/kg (1 spray) + NaCl 0,9% IV
~at 20 minutes and if NPRS>3: Sufentanil IN 0,15µg/kg (1 spray) + NaCl 0,9% IV"
16109183|NCT02095366|Drug|Placebo|"Intravenous administration Patient receives simultaneously IV placebo administration and IN sufentanil spray.
~Pain is controlled by:
~at 0 minute : Sufentanil IN 0,3µg/kg (2 sprays, one spray in each nostril) + NaCl 0,9% IV
~at 10 minutes and if NPRS>3 : Sufentanil IN 0,15µg/kg (1 spray) + NaCl 0,9% IV
~at 20 minutes and if NPRS>3: Sufentanil IN 0,15µg/kg (1 spray) + NaCl 0,9% IV"
16109184|NCT02095366|Drug|Placebo|"Intranasal spray with one spray, equivalent to an half-dose. Patient receives simultaneously IV morphine administration and IN placebo spray.
~Pain is controlled by:
~at 0 minute : Placebo IN (2 sprays, one spray in each nostril) + morphine IV 0,1mg/kg
~at 10 minutes and if NPRS>3 : Placebo IN (1 spray) + morphine IV 0,05mg/kg
~at 20 minutes and if NPRS>3: Pacebo (1 spray) + morphine IV 0,05mg/kg"
16109185|NCT02095340|Other|Positive Interpretation Bias Training|
16109186|NCT02095340|Other|Neutral Interpretation Bias Training|
16109187|NCT02095314|Biological|Pentavalen|Batch 5010613
16109188|NCT02095301|Other|Herbal Beverage|
16109189|NCT02095288|Procedure|Blood draw|This is a single blood donation, no drugs or devices administered
16109190|NCT02095262|Other|reactive auditory training|
16109191|NCT02095262|Other|Interactive auditory training|
16109192|NCT02095249|Drug|Pimonidazole|Pimonidazole is to be administered to patients scheduled for radical prostatectomy one day prior to surgery.
16109193|NCT02095236|Behavioral|organ motion|Three-dimensional intrafractional motion of a fiducial marker or a transponder during a radiotherapy treatment session. Image and/or signal acquisition will be performed by ultrasound, computed tomography, magnetic resonance imaging or by specialized signal detectors.
16109231|NCT02094937|Drug|Fluticasone Furoate 100 mcg|FF 100 mcg is available as a dry white powder to be given once daily in the evening via dry powder inhaler
16109232|NCT02094937|Drug|Fluticasone Propionate 250 mcg|FP 250 mcg is available as a dry white powder to be given twice daily (morning and evening) via dry powder inhaler
16109233|NCT02094937|Drug|Fluticasone Propionate 100 mcg|FP 100 mcg is available as a dry white powder to be given twice daily (morning and evening) via dry powder inhaler
16110654|NCT02084056|Drug|Metformin|Metformin
16109194|NCT02095223|Device|Electromyographic Biofeedback|Electromyographic biofeedback is a device that enables a patient or clinician to measure the intensity of a muscle contraction using electrodes placed on the skin over a muscle of interest. In this study, participants in the electromyographic biofeedback supplemented exercise will also be instructed on correct setup and use of the electromyographic biofeedback unit. These instructions will focus on correct placement of the electromyographic recording electrodes over quadriceps muscle as well as correct tuning of the feedback threshold for each exercise to maximize the benefit of the intervention. Electromyographic biofeedback will be used during all exercises throughout the course of the study for this group.
16109195|NCT02095223|Behavioral|Traditional Exercise|All participants will be asked to complete 3 set of 10 repetitions of isometric quadriceps contractions with a 15 second hold time, supine straight leg raises, body weight squatting, and body weight lunges daily. Participants will be required to complete the single limb exercises on the previously injured limb only.
16109196|NCT02095210|Other|Radiolabeled [68Ga]ABY-025|Single dose of 100 μg ABY-025 labeled with 500 MBq gallium-68, administrated as a slow intravenous injection. All patients will receive the same dose.
16109197|NCT02095197|Drug|Triamcinolone 80mg|C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.
16109198|NCT02095184|Drug|Anastrozole|1 mg daily
16109199|NCT02095184|Drug|Letrozole|2.5 mg daily
16109200|NCT02095171|Drug|PRX002|
16109201|NCT02095171|Other|Placebo|
16109202|NCT02095158|Drug|Oxymetazoline HCL Cream 1.0%|Oxymetazoline HCL Cream 1.0% applied to the face once daily for 52 weeks.
16109203|NCT02095145|Other|Laboratory Biomarker Analysis|Correlative studies
16109204|NCT02095145|Other|Pharmacological Study|Correlative studies
16109205|NCT02095145|Other|Placebo|Given PO
16109206|NCT02095145|Drug|Pomegranate-Extract Pill|Given PO
16109207|NCT02095132|Drug|Adavosertib|Given PO
16109208|NCT02095132|Drug|Irinotecan Hydrochloride|Given PO
16109209|NCT02095119|Drug|Nimotuzumab|Monoclonal antibody Nimotuzumab will be administered alone at a 200mg dose weekly during the first 4 weeks. Posteriorly it will be administered with a maintenance dose of 200 mg every 2 weeks in combination with chemotherapeutic agents Cisplatin in patients with good renal function or Gemcitabine in patients with kidney failure data until exclusion or death occurs. The administration will be intravenously in 250 ml of saline solution in a time period of 30 minutes.
16109210|NCT02095119|Drug|Cisplatin|Cisplatin will be administered at a calculated dose of 50mg/m2/BSA every 21 days as concomitant therapy to Nimotuzumab, until 6 cycles are completed, exclusion or death occurs, only in patients whose creatinine clearance as defined by the Cockcroft-Gault equation is >/= 60. The administration form will be intravenously.
16109211|NCT02095119|Drug|Gemcitabine|Gemcitabine will be administered at a calculated dose of 800 mg/m2/BSA every 21 days as concomitant therapy to Nimotuzumab, until 6 cycles are completed, exclusion or death occurs, in patients with kidney failure data(Creatinine clearance as defined by the Cockcroft -Gault equation < 60). The administration form will be intravenously.
16109212|NCT02095119|Procedure|CT Scan|A CT Scan will be performed in all patients prior to the beginning of treatment to assess any measurable tumor found by this method. The CT Scan will be repeated once the patient completes the induction phase with Nimotuzumab (4 once a week doses), when the patient has completed 3 full cycles of combination therapy with Nimotuzumab (every 2 weeks)and Gemcitabine or Cisplatin (every 21 days)and once more when the patient has completed 6 full cycles of the aforementioned therapy.
16109213|NCT02095106|Device|Waterproof Cast|
16109214|NCT02095106|Device|Traditional cast|
16109215|NCT02095093|Device|Intellijoint HIP|Intellijoint HIP is an intra-operative, imageless intelligent instrument used to provide real-time information to surgeons about leg length and hip offset changes during total hip replacement surgery.
16109216|NCT02095093|Device|Outrigger|The outrigger is a pin and caliper device that is used to assess leg length and offset during total hip arthroplasty. It is the current standard of care at Mount Sinai Hospital.
16109217|NCT02095080|Dietary Supplement|Leucine intake|Oral consumption of eight hourly experimental meals- Includes 4 tracer-free experimental meals containing a mixture of free amino acids, calories from a flavored liquid and protein free cookies and 4- labeled amino acid experimental meals.
16109218|NCT02095067|Device|Video consultation|
16109219|NCT02095054|Drug|Regorafenib|"Dose Escalation Group Starting Dose of Regorafenib: 80 mg by mouth once a day for 21 days (5 days on and 2 days off) in a 28 days cycle.
~Dose Expansion Group Starting Dose of Regorafenib : MTD from Dose Escalation Group."
16109220|NCT02095054|Drug|Cetuximab|"Dose Escalation Group Starting Dose of Cetuximab: 200 mg/m2 initial dose, then 150 mg/m2 by vein over about 1-2 hours on Days 1, 8, 15, and 22 of each 28 day cycle.
~Dose Expansion Group Starting Dose of Cetuximab: MTD from Dose Escalation Group."
16109221|NCT02095054|Behavioral|Questionnaire|Symptom questionnaire completed at each study visit.
16109222|NCT02095028|Behavioral|Dietary and lifestyle intervention|participants in the intervention group were provided with an individualized dietary intake protocol. Patients received a diet of not fewer than 1500 calories per day in the first trimester and not fewer than 1800 calories per day after 13wks of gestation.
16109223|NCT02094989|Other|posture dependence of VCG-ECG-transformation|
16109224|NCT02094976|Device|Jackson surgical table|After standard total intravenous anesthesia using propofol and remifentanil continous infusion, patients were turned to the prone position on a Jackson table with two padded supports on each side. The supports were positioned under the lateral chest and at the iliac crest.
16109225|NCT02094976|Device|Wilson frame|After standard total intravenous anesthesia using propofol and remifentanil continous infusion, patients were turned to the prone position on a Wilson frame. The supports were positioned vertically from shoulder to iliac crest.
16109226|NCT02094976|Device|Chest roll|After standard total intravenous anesthesia using propofol and remifentanil continous infusion, patients were turned to the prone position on a chest roll. The supports were positioned vertically from shoulder to iliac crest.
16109227|NCT02094963|Drug|Ticagrelor|180mg loading and 90mg bid
16109228|NCT02094963|Drug|Clopidogrel|600mg loading and 75mg qd
16109229|NCT02094950|Procedure|Acupuncture|
16109230|NCT02094937|Drug|Fluticasone Furoate/Vilanterol|FF/VI 100mg/25 mcg is available as a dry white powder to be given once daily in the evening via dry powder inhaler
16109234|NCT02094937|Drug|Fluticasone Furoate Placebo|Matching placebo of Fluticasone Furoate will be given once daily in the evening via dry powder inhaler
16109235|NCT02094937|Drug|Fluticasone Propionate Placebo|Matching placebo of Fluticasone Propionate will be given twice daily (morning and evening) via dry powder inhaler
16109236|NCT02094924|Drug|GSK587323|Single dose of FDC tablet formulation to be taken orally.
16109237|NCT02094924|Drug|FDC of candesartan cilexetil 16 mg and HCTZ 12.5mg|Single dose of FDC tablet formulation to be taken orally
16109238|NCT02094911|Behavioral|Combined lifestyle intervention|"10-month intervention period with:
~weekly group-based sports lessons supervised by a physiotherapist
~individual dietary advice by a dietician
~case management by practice nurse
~maintenance programme to guide subjects to maintain lifestyle behaviour change"
16109239|NCT02094911|Other|Usual care group|Written information on healthy lifestyle was provided at baseline, no individual advice or programme was provided. No additional appointments were scheduled, apart from the visits for follow-up measurements
16109240|NCT02094898|Drug|Ketamine|0.3 mg/kg/hr of ketamine infused for 100 minutes
16109241|NCT02094885|Biological|Bioseal Fibrin Sealant|
16109242|NCT02094885|Other|Manual Compression|
16109243|NCT02094872|Other|cytology specimen collection procedure|Undergo collection of tissue and blood samples
16109244|NCT02094872|Drug|MEK 162 therapy or molecularly targeted therapy|molecularly targeted therapy, MEK 162 therapy
16109245|NCT02094872|Procedure|therapeutic procedure|
16109246|NCT02094872|Other|laboratory biomarker analysis|Correlative studies
16109247|NCT02094872|Other|quality-of-life assessment|Ancillary studies
16109248|NCT02094846|Behavioral|Voice messages|Voice messages reinforced with self-efficacy
16109249|NCT02094833|Biological|DTaP-IPV-Hep B-PRP~T combined vaccine|0.5 mL, Intramuscular
16109250|NCT02094833|Biological|DTaP-IPV//PRP~T and Hepatitis B vaccine|0.5 mL, Intramuscular
16109251|NCT02094807|Drug|NSAID|Will be used if other drugs are not tolerated.
16109252|NCT02094807|Procedure|thoracic epidural anesthesia|Continous epidural anesthesia will be introduced by specialists in Anesthesia and Intensive care.
16109253|NCT02094807|Drug|opioids|During firs 24 hours i.v will be used. Then slow releas tabletts will be preferred.
16109254|NCT02094807|Drug|paracetamol|100mg x 4 i.v. during the first 24 hours. Then orally 100mg x 4.
16109255|NCT02094807|Procedure|operative fixation of rib fractures|Fractures will be stabilized on the outside of of the ribs.
16109256|NCT02094794|Drug|etoposide|Given IV
16109257|NCT02094794|Drug|cyclophosphamide|Given IV
16109258|NCT02094794|Radiation|total marrow irradiation|Undergo TMLI
16109259|NCT02094794|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo allogeneic peripheral blood stem cell or bone marrow transplant
16109260|NCT02094794|Procedure|allogeneic bone marrow transplantation|Undergo allogeneic peripheral blood stem cell or bone marrow transplant
16109261|NCT02094781|Dietary Supplement|Whey protein and creatine supplement|Each sachet contained 30g whey protein powder and 5g creatine powder, administered twice a day. The first serving was consumed with breakfast and the second serving was consumed within 60 minutes of completing training or in the evening on non-training days. Participants also drank at least 2 litres of water per day
16109262|NCT02094781|Dietary Supplement|Whey protein only supplement|Each sachet contained 30g of whey protein powder and 5g of bulking agent powder, administered twice a day. The first serving was consumed with breakfast and the second serving was consumed within 60 minutes of completing training or in the evening on non-training days. Participants also drank at least 2 litres of water per day
16109263|NCT02094781|Dietary Supplement|Placebo|Each sachet contained 30g of isocaloric carbohydrate powder and 5g of bulking agent powder, administered twice a day. The first serving was consumed with breakfast and the second serving was consumed within 60 minutes of completing training or in the evening on non-training days. Participants also drank at least 2 litres of water per day
16109264|NCT02094768|Dietary Supplement|Reduced Fat Milk|Subjects will be provided with and instructed to consume the equivalent of 20oz. reduced fat milk per day for 3 weeks
16109265|NCT02094768|Dietary Supplement|Sugar Sweetened Soda|Subjects will be provided with and instructed to consume 2 cans (24oz) of sugar sweetened soda per day for 3 weeks
16109266|NCT02094755|Other|Blood draw only|Blood draw only
16109267|NCT02094742|Procedure|biopsy|
16109268|NCT02094729|Drug|BAN2401 2.5 mg/kg|Cohorts 1: Intravenous infusions of 2.5 mg/kg BAN2401 for 60 +/- 10 minutes.
16109269|NCT02094729|Drug|BAN2401 5 mg/kg|Cohorts 2: Intravenous infusions of 5 mg/kg BAN2401 for 60 +/- 10 minutes.
16109270|NCT02094729|Drug|BAN2401 10 mg/kg|Cohorts 3: Intravenous infusions of 10 mg/kg BAN2401 for 60 +/- 10 minutes
16109271|NCT02094729|Drug|Placebo|Intravenous infusions of placebo for 60 +/- 10 minutes.
16109272|NCT02094716|Drug|Permethrin Foam 4%|Topical application, whole-body treatment
16109273|NCT02094716|Drug|Permethrin Foam 5%|Topical application, whole-body treatment
16109274|NCT02094716|Drug|Vehicle Foam|Topical application, whole-body treatment
16109275|NCT02094703|Drug|Levofloxacin|
16109276|NCT02094703|Drug|Solifenacin succinate|
16109277|NCT02094703|Drug|Placebo (for Solifenacin succinate)|
16109278|NCT02094690|Device|Therabite|10 repetitions holding Therabite for 30 seconds. The exercises should begin one day before the onset of Radiotherapy and kept until the end of RT. Repeated 4x a day (after breakfast, lunch, dinner and before going to bed).
16109279|NCT02094690|Device|Hyperboloid|5 min of bilateral mastication alternated with hyperboloid. The exercises should begin one day before the onset of Radiotherapy and kept until the end of RT. Repeated 4x a day (after breakfast, lunch, dinner and before going to bed).
16109280|NCT02094677|Device|filcon II 3|Participants were randomized to wear filcon II 3 test lens.
16109281|NCT02094677|Device|etafilcon A|Participants were randomized to wear etafilcon A control lens.
16109282|NCT02094677|Device|nelfilcon A|Participants were randomized to wear nelfilcon A control lens.
16109283|NCT02094664|Device|Heated and humidified oxygen|
16109284|NCT02094651|Drug|divalproex sodium|The drug is an FDA approved medication for seizures but has not been approved for the treatment of epileptiform EEG abnormalities in the absence of clinical seizures.
16109286|NCT02094625|Drug|N-Acetylcysteine|"NAC will be administered intravenously over ~60 minutes starting 4 hours following completion of cisplatin chemotherapy.
~Three dose levels have been pre-determined:
~Dose Level 1: 225 mg/kg Dose Level 2: 300 mg/kg Dose Level 3: 450 mg/kg
~Should Dose Level 3 exceed the MTD, the study will examine blood levels of NAC and if below the target blood level necessary for hearing protection, the study will de-escalate from Dose Level 3 to an intermediate Dose Level 2.5 and test a dose of 375 mg/kg.
~As of August 2018: Dose escalation completed with MTD not reached. Dose level 3 (450mg/kg) selected for expansion with NAC."
16109287|NCT02094612|Device|Quotient®|Patients will be randomized once at the time of ADHD assessment to either usual clinic ADHD care or usual clinic ADHD care plus the Quotient using computer-generated random numbers.
16109288|NCT02094612|Behavioral|Usual Clinic ADHD Care|Usual ADHD care as provided by the clinic
16109289|NCT02094599|Drug|Dronabinol 10 mg|Dronabinol at a strength equivalent to 10 mg provided in capsules or as an oral solution in syringes.
16109290|NCT02094599|Drug|Dronabinol 30 mg|Dronabinol at a strength equivalent to 30 mg provided in capsules or as an oral solution in syringes.
16109291|NCT02094599|Drug|Placebo|Matching placebo provided in capsules or as an oral solution in syringes.
16109292|NCT02094586|Biological|PXVX0200 Lot A|Lot P700-1CA03
16109293|NCT02094586|Biological|PXVX0200 Lot B|Lot P700-3CA03
16109294|NCT02094586|Biological|PXVX0200 Lot C|Lot P700-6BA03
16109295|NCT02094586|Biological|Placebo|Placebo
16109296|NCT02094573|Drug|Brigatinib|Brigatinib tablets
16109297|NCT02094560|Drug|CAP7.1|CAP7.1 is a prodrug of Etoposide released after via specific carboxyesterase
16109298|NCT02094547|Dietary Supplement|New infant formula|New infant formula
16109299|NCT02094547|Dietary Supplement|Standard infant formula|Standard infant formula
16109300|NCT02094547|Dietary Supplement|Breastfeeding|Exclusive breastfeeding or less tan 25% formula intake
16109301|NCT02094534|Biological|ORMD-0801 Capsules|API (recombinant human insulin USP), in Oramed's proprietary formulation in capsules.
16109302|NCT02094534|Other|Placebo|Fish oil capsules, identical in appearance to the experimental intervention.
16109303|NCT02094521|Drug|NNC0113-0987|For oral administration. All subjects will be treated for 10 consecutive days with five days on 5 mg NNC0113-0987 followed by five days on 10 mg NNC0113-0987. Dose escalation is chosen to increase gastrointestinal tolerability.
16109304|NCT02094482|Device|The IMD is a resilient palatal implant which is introduced through a stab incision into the palate.|The IMD is a resilient palatal implant which is introduced through a stab incision into the palate. Two implants are placed underneath the rostral part of the palatal bone and continue into the upper part of the soft palate
16109305|NCT02094469|Drug|Cilostazol|Oral, Bid, 24 weeks
16109306|NCT02094456|Procedure|Endoscopic clipping of diverticula|Colonoscopy with identification of each individual colonic diverticula and endoscopic clipping.
16109307|NCT02094456|Procedure|Follow-up colonoscopy|Patients will undergo a repeat colonoscopy 6 months after endoscopic clipping procedure.
16109308|NCT02094443|Drug|Alisporivir|ALV 100 and 200 mg soft gel capsules administered orally
16109309|NCT02094443|Drug|Ribavirin|RBV 200 mg tablets (weight-based dose: < 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose
16109310|NCT02094430|Drug|biological: human fibrinogen concentrate|
16109311|NCT02094417|Drug|AMG531|Subcutaneous, weekly injection
16109312|NCT02094391|Drug|Ipilimumab|Ipilimumab is to be administered as an IV infusion with a 1.2μm in-line filter (see current version of Investigator's Brochure), using a volumetric pump, at the 3 mg/kg dose, at the ratio and rate specified in the pharmacy manual, to complete the infusion in 90 minutes with a 100 cc normal saline flush at the end. The total dose needed should be diluted to a total volume of 250 mL in 0.9% sodium chloride injection, USP or 5% Dextrose Injection, USP.. The total dose must be calculated using the most recent subject weight (obtained on the same day of, and prior to, the infusion). If the patient weighs more than 125,0 kg, the Coordinating Investigator needs to be contacted to discuss the total infusion volume, infusion rate and duration. Ipilimumab 3 mg/kg will be administered as a single dose intravenously over 90 minutes every 3 weeks for 4 cycles (Weeks W1, W4, W7, W10). A time interval of +/- 3 days is allowed for Ipilimumab administration.
16109313|NCT02094378|Drug|Esketamine|84 mg esketamine administered intranasally
16109314|NCT02094378|Drug|Placebo|Placebo administered intranasally
16109315|NCT02094365|Drug|ALS-008176|
16109316|NCT02094365|Drug|vehicle|
16109317|NCT02094352|Drug|Ketamine Infusion + Epidural Infusion|The ketamine and epidural infusions will be administered over 96 hours with appropriate titration.
16109318|NCT02094352|Drug|Control Group + Epidural infusion|The saline and epidural infusions will be administered over 96 hours with appropriate titration.
16109319|NCT02094352|Drug|Ketamine Booster Infusion|Patients will receive three ketamine booster infusions over the course of three months.
16109320|NCT02094352|Drug|Control Group Booster Infusion|Patients will receive three saline booster infusions over the course of three months.
16109321|NCT02094339|Procedure|Local analgesic|Patient will be performed under combined lumbar plexus and sciatic nerve block with 0.33% ropivacaine.At the end of surgery,two catheters are left in the wound.One is intraarticular and the other is on the surface of articular cavity.And then a pump elastomeric infusion pump will be connected with the catheters, which runs 5mL every hours.
16109322|NCT02094339|Procedure|Nerve Block|Combined lumbar plexus and sciatic nerve block with 0.33% ropivacaine will be performed before the surgery.After the a bolus of 30mL ropivacaine around lumbar plexus,a catheter will be left in Psoas gap with 6cm.A pump elastomeric infusion pump running 5mL every hours will also be connected with the catheters at the end of the operation.
16109323|NCT02094339|Procedure|Intravenous analgesic|People in this group will also receive an anesthesia of combined lumbar plexus and sciatic nerve block with 0.33% ropivacaine.An intravenous electronic analgesia pump infusion of flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg will will provide postoperative pain management.The patients will received a 2 mL/h continuous basal infusion and 1 mL boluses with a lockout time of 30 min after a 5 mL Loading dose at the end of the surgery.
16109324|NCT02094339|Drug|ropivacaine|0.2% ropivacaine
16109325|NCT02094339|Drug|ropivacaine|0.2% ropivacaine
16109326|NCT02094339|Drug|opioid|flurbiprofen axetil 250mg,palonosetron 0.5mg,pentazocine 240mg.dezocine 30mg
16109327|NCT02094313|Drug|Atorvastatin|The aim of this pilot study is to evaluate the efficacy and the safety of a decrease of cholesterol blood levels, induced by taking atorvastatin, on sperm quality of normocholesterolaemic and healthy men without confounding factors.
16109328|NCT02094300|Device|Zenith® Dissection Endovascular Graft|Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guide the study device(s) into place in the aorta.
16109329|NCT02094287|Drug|dimetindene|receiving either dimetindene or a placebo (saline) via infusion
16109330|NCT02094287|Behavioral|instruction|information about the drug dimetindene and its efficacy versus no information and unawareness of treatment influencing expectations of an efficient treatment
16109331|NCT02094287|Other|conditioning|classical conditioning; experiencing and observing the efficiency of a drug manipulated by a conditioning process versus no learning experience.
16109332|NCT02094274|Drug|LAS40468|
16109333|NCT02094274|Drug|Salmeterol/fluticasone propionate|
16109334|NCT02094274|Drug|Placebo|
16109335|NCT02094261|Drug|AZD9291|Once daily tablet 80 mg
16109336|NCT02094248|Drug|TPO|rhTPO（Recombinant Human Thrombopoietin，TPIAO®, Shenyang Sunshine Pharmaceutical Company Limited [SUNSHINE], Shenyang, China）， 15000U/ml, s.c injection
16109337|NCT02094248|Drug|control|Normal saline，1ml/day, s.c injection
16109338|NCT02094235|Drug|E6005 0.05%|
16109339|NCT02094235|Drug|Placebo|0.5 g placebo ointment
16109340|NCT02094235|Drug|E6005 0.2%|
16109341|NCT02094222|Drug|RAVICTI|open label expanded access protocol of titrated dosing regimen of RAVICTI for up to 60 weeks
16109342|NCT02094209|Device|SmartFix|AO Fracture Monitor attached postoperatively to a connection rod of the external fixator. The device continuously measures deformation of the fixator frame due to weight bearing for up to 4 months by means of a strain gauge.
16109343|NCT02094196|Other|Alcohol detoxification|Detoxified alcohol- dependent patients in an inpatient setting
16109344|NCT02094183|Other|GLP-1|GLP-1
16109345|NCT02094183|Dietary Supplement|low calorie diet|low calorie diet
16109346|NCT02094157|Drug|Tapered warfarin regimen|This intervention is assigned to the experimental arm - Tapered warfarin regimen
16109347|NCT02094157|Drug|Bridged regimen Low-molecular-weight heparin|This intervention is assigned to the active control arm - Bridged regimen
16109348|NCT02094144|Other|Brisk walking program|The intervention consists on achieve 40 minutes of brisk walking 3d/wk for 6 months (two supervised sessions and one session performed one their own per week with a detailed program). The intensity of the program is adapted to the heart rate work and gradually increases over the 6-month program
16109349|NCT02094144|Other|physical activity habit|The Intervention consists on maintain the lifestyle and especially their physical activity habits during 6 months
16109350|NCT02094131|Other|Voldyne group (VG)|"VG: slow deep breaths through the mouthpiece of the incentive Voldyne5000® were conducted from the tidal volume (TV) until the total lung capacity (TLC), holding the maximum inspiration. All individuals should maintain yellow cup (yellow flow cup) at a range of flow Best in as long as possible. The training lasted approximately 50 minutes, were held twice a week on alternate days, for five consecutive weeks, totaling 10 sessions. Performed three sets of 15 repetitions."
16109351|NCT02094131|Other|Cliniflo group (CG)|"CG: slow deep breaths through the mouthpiece of the incentive Cliniflo® from tidal volume (TV) were performed until the total lung capacity (TLC), holding the maximum inspiration. The volume flow of 100 ml / s for Cliniflo® was standardized, being envisaged to keep the yellow indicator behind the happy face for all individuals.The training lasted approximately 50 minutes, were held twice a week on alternate days, for five consecutive weeks, totaling 10 sessions. Performed three sets of 15 repetitions."
16109352|NCT02094118|Biological|Point-of-care washed red blood cell transfusion.|
16109353|NCT02094118|Biological|Standard of care red blood cell transfusion.|
16109354|NCT02094105|Procedure|Endoscopy examination with iodine staining|Endoscopy examination with Lugol's iodine staining and questionnaire once time and early treatment on precancerous lesions was undergone for the intervention group.
16109355|NCT02094092|Other|ProTectis drops (five drops per day) for 21 days|
16109356|NCT02094092|Other|Placebo drops (five drops per day) for 21 days|
16109357|NCT02094079|Other|biomedical outcomes|Evaluation of abnormal blodtests (evaluating thyroid function) from predefined control program
16109358|NCT02094066|Drug|tranexamic acid|preoperative ıv 50 mg/kg tranexamic acid infusion at 45 minutes
16109359|NCT02094066|Drug|serum physiologic|preoperative 100 cc ıv serum physiologic
16109360|NCT02094053|Drug|E2020-Donepezil hydrochloride|3 mg of E2020 (oral) once daily, for 24 weeks
16109361|NCT02094053|Drug|E2020-Donepezil hydrochloride|5 mg of E2020 (oral) once daily, for 24 weeks
16109362|NCT02094053|Drug|Placebo|placebo (oral) once daily, for 24 weeks
16109363|NCT02094040|Behavioral|Receive municipality-based follow-up visit|Systematic electronic referral from hospital to municipality of high risk people at discharge from a medical ward. Contact from municipality service to primary physician and citizen, to arrange first home visit within 7 days with focus on: medication, rehabilitation plan and health care appointments, functional level and need for further health care initiatives. The visit is concluded by planning of further visits (up till tree) and division of responsibilities between primary physician and the municipality service.
16109364|NCT02094027|Behavioral|Guided Self Help|A behaviourally orientated guided self help book designed to reduce binge eating prior to surgery
16109365|NCT02094027|Other|Treatment As Usual|Binge eating disordered participants receive treatment as usual in the form of bariatric surgery (i.e. no pre-operative intervention to reduce binge eating)
16109366|NCT02094014|Behavioral|Normal Auditory Feedback|Participants will produce sentences under normal speaking conditions, able to hear their own speech.
16109367|NCT02094014|Behavioral|Masked Auditory Feedback|Participants will produce sentences while listening to speech-shaped noise at 85 decibels (sound pressure level) to mask ability to hear their own speech.
16109368|NCT02094014|Behavioral|Altered Auditory Feedback|Participants will produce sentences while listening to their speech shifted up one octave and delayed.
16109473|NCT02093169|Drug|Part B: Lu AF35700|Daily dosing: 10 mg for 3 days, 20 mg for 3 days, 45 mg on Day 7; orally
16109550|NCT02092584|Dietary Supplement|Omega-3|4 cap 1 g Omega-3 per day for 2 months
16109369|NCT02094001|Radiation|Cardiac PET imaging using F-18-FDG, N-13 ammonia( NH3)|After an overnight fast, patients will undergo a 20 minute dynamic PET scan with injection of 3 MBq/kg of N-13 ammonia (NH3) to measure myocardial perfusion. Followed by a 60 min dynamic PET scan with injection of 3MBq/kg of F-18-FDG to measure glucose uptake.
16109370|NCT02093988|Drug|Topical TXA|
16109371|NCT02093988|Drug|Intravenous TXA|
16109372|NCT02093975|Device|iPad air with 4G/3G SIM card|"iPad air with 4G/3G SIM card is used as device for videoconferencing. LifeSizeClearSea solution is used for videoconferencing.
~Video consultation"
16109373|NCT02093962|Drug|TH-302 combination with pemetrexed|"400 mg/m2 of TH-302 will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.
~Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after TH-302 administration."
16109374|NCT02093962|Drug|Matched placebo in combination with pemetrexed|"Matched placebo will be administered by IV infusion over 30 - 60 minutes on Day 1 and Day 8 of a 21-day cycle.
~Pemetrexed (500 mg/m2) will be administered as an IV infusion on Day 1 two - four hours after placebo administration."
16109375|NCT02093949|Procedure|Routine substrate ablation without pulmonary vein Isolation|
16109376|NCT02093949|Procedure|Routine conventional ablation with pulmonary vein Isolation|
16109377|NCT02093923|Drug|DX-2930|Participants will receive SC injection of DX-2930 (a recombinant, Chinese hamster ovary [CHO] cell expressed, fully human immunoglobulin IgG1, kappa light chain, monoclonal antibody) once and followed by the second dose after 2 week into the upper arm.
16109378|NCT02093923|Drug|Placebo|Participants will receive matching placebo subcutaneously.
16109379|NCT02093910|Drug|Monosialotetrahexosylganglioside|
16109380|NCT02093897|Biological|rVIII-SingleChain|
16109381|NCT02093884|Other|Text Messaging Intervention|
16109382|NCT02093884|Other|Standard Referral|
16109383|NCT02093871|Device|ThermalCore Hyperthermia System|Patients will undergo 6 cycles of therapeutic hyperthermia with the ThermalCore Perfusion Induced Systemic Hyperthermia System every 28 days
16109384|NCT02093845|Device|Biomatrix NeoFlex coronary stent|Percutaneous coronary intervention involving use of stent
16109385|NCT02093845|Device|SYNERGY stent|Percutaneous coronary intervention involving use of stent
16109386|NCT02093832|Other|There are no specific Intervention|are no specific Intervention
16109387|NCT02093819|Drug|Placebo to BI 416970|single rising doses
16109388|NCT02093819|Drug|BI 416970|single rising doses
16109389|NCT02093806|Other|measurment|
16109390|NCT02093793|Device|PRECISION SCS Adapted for High-Rate SCS|Comparison of spinal cord stimulation parameters
16109391|NCT02093780|Behavioral|Alberta Anti-inflammatory diet|Patients randomized to Alberta Anti-inflammatory diet will follow a strict menu plan designed by certified dietitian for 6 months.
16109392|NCT02093780|Behavioral|Canada's Food Guide Diet|Patients randomized to Canada's Food Guide diet will receive counseling by certified dietitian for 6 months and will design their own diet following Canada's Food Guide.
16109393|NCT02093767|Dietary Supplement|Synergy1|The prebiotic preparation, Synergy-1, consists of 1:1 inulin and oligosaccharide. The chicory derived inulin has a degree of polymerization (DP) of 10 to 60 (average DP of 25). The oligofructose is produced by partial enzymatic hydrolysis of chicory derived inulin and has a DP ranging between 3 and 7 (average DP of 4).
16109394|NCT02093754|Procedure|MRI and biopsy|
16109395|NCT02093741|Biological|Octocog alfa (recombinant human coagulation factor VIII) [ADVATE]|The investigators shall determine all treatment regimens according to product labeling information and standard practice.
16109396|NCT02093728|Drug|selumetinib|Volunteers will recieve single oral dose of 25mg selumetinib in sequence 1, treatment A
16109397|NCT02093728|Drug|itraconazole|Volunteers will receive oral doses of itraconazole 200 mg twice daily on Day 1 to Day 7 in sequence 1 treatment B:
16109398|NCT02093728|Drug|itraconazole|Volunteers will recieve a single morning dose of 200mg itraconazole on Day 8 and twice daily doses of 200mg itraconazole on Day 8 to Day 11; sequence 1 treatment C.
16109399|NCT02093728|Drug|selumetinib|Volunteers willl recieve a single oral dose of 25 mg selumetinib (4 hours fasted state) on Day 8; sequence 1 treatment C.
16109400|NCT02093728|Drug|selumetinib|Volunteers will recieve single oral dose of 25mg selumetinib in sequence 2, treatment A.
16109401|NCT02093728|Drug|fluconazole|Volunteers will recieve a single dose of 400 mg fluconazole on Day 1 and daily doses of 200 mg fluconazole on Day 2 to Day 7; sequence 2 treatment D.
16109402|NCT02093728|Drug|fluconazole|Volunteers will receive a morning dose of 200mg fluconazole on Day 8 and daily doses of 200mg fluconazole on Day 8 to Day 11; sequence 2 treatment E
16109403|NCT02093728|Drug|selumetinib|Volunteers will receive a single dose of 25mg selumetinib (4 hours fasted state) on Day 8; sequence 2 treatment E
16109404|NCT02093702|Behavioral|Physical activity and exercise education and behaviour counseling from a Registered Kinesiologist and a YMCA Wellness Coach|
16109405|NCT02093702|Behavioral|Unstructured Physical Activity and Exercise Education|
16109406|NCT02093689|Drug|Part 1 OMS302|OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5-mL solution containing 60.75 mM phenylephrine HCl (12.37 mg/mL) and 11.25 mM ketorolac trometamol (4.24 mg/mL) formulated in a 20 mM sodium citrate buffer (pH 6.3 ± 0.5). For administration to patients, 4.0 mL of the drug product is added to a 500-mL bottle of commercially available irrigation solution.
16109407|NCT02093689|Drug|Part 2 OMS302|OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5-mL solution containing 60.75 mM phenylephrine HCl (12.37 mg/mL) and 11.25 mM ketorolac trometamol (4.24 mg/mL) formulated in a 20 mM sodium citrate buffer (pH 6.3 ± 0.5). For administration to patients, 4.0 mL of the drug product is added to a 500-mL bottle of commercially available irrigation solution.
16109408|NCT02093689|Drug|Part 2 Placebo|Placebo drug product is a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL of solution containing 20 mM sodium citrate buffer (pH 6.3 ± 0.5). For administration to patients, 4.0 mL of the drug product is added to a 500-mL bottle of commercially available irrigation solution.
16109409|NCT02093676|Behavioral|"experimental protocol treatment The New Authority"|
16109547|NCT02092597|Drug|Exenatide|
16109548|NCT02092597|Drug|Linagliptin|
16109410|NCT02093663|Drug|MMX Mesalamine/Mesalazine (Low Dose)|Once daily, tablets - the amount depends on the participants weight; 900 milligram per day (mg/day) for participants weighing 18 kg to less than or equal to (<=) 23 kilograms (kg); 1200 mg/day for participants weighing greater than (>) 23 kg to <= 35 kg; 1800 mg/day for participants weighing > 35 kg to <= 50 kg; 2400 mg/day for participants weighing > 50 kg to <= 90 kg.
16109411|NCT02093663|Drug|MMX Mesalamine/Mesalazine (High Dose)|Once daily, tablets - the amount depends on the participants weight;1800 mg/day for participants weighing 18 kg to <= 23 kg; 2400 mg/day for participants weighing > 23 kg to <= 35 kg; 3600 mg/day for participants weighing > 35 kg to <= 50 kg; 4800 mg/day for participants weighing > 50 kg to <= 90 kg.
16109412|NCT02093650|Drug|black cohosh extract|Black cohosh extract 80 mg
16109413|NCT02093650|Drug|Placebo|Soy bean oil
16109414|NCT02093637|Other|Placebo acupuncture|Placebo Comparator
16109415|NCT02093637|Other|Battlefield Acupuncture|Experimental
16109416|NCT02093611|Dietary Supplement|Placebo|
16109417|NCT02093611|Dietary Supplement|ATP|400 mg of ATP
16109418|NCT02093598|Drug|Temsirolimus|
16109419|NCT02093585|Drug|abacavir (600 mg QD)|
16109420|NCT02093585|Drug|tenofovir (245 mg QD)|
16109421|NCT02093572|Other|3 standard meals/day|
16109422|NCT02093572|Other|2 meals/day (omit breakfast)|
16109423|NCT02093559|Behavioral|Brief counseling Intervention|The brief counseling intervention will utilize MI and skills-building techniques to modify personal overdose risk behaviors and develop skills as a peer responder for witnessed overdose. The counselor will draw upon themes of safer substance use to address HIV risk behaviors and determine readiness for change in substance use.
16109424|NCT02093546|Procedure|Biospecimen Collection|Undergo collection of blood and tumor
16109425|NCT02093533|Drug|Eculizumab|
16109426|NCT02093520|Procedure|MILD Procedure|The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue.
16109427|NCT02093520|Drug|Epidural Steroid Injection|Injection of epidural steroids into the lumbar spine
16109428|NCT02093507|Other|parents manipulation|parents perform manipulation the child foot to correct the deformity
16109429|NCT02093494|Device|Initial Specimen Diversion Device (ISDD)|
16109430|NCT02093494|Procedure|Lab standard practice (LSP)|
16109431|NCT02093494|Device|Peripheral Intravenous Catheters (PIVC)|
16109432|NCT02093481|Other|Test meal|
16109433|NCT02093481|Other|Reference|
16109434|NCT02093481|Other|Priming|The reference or test meal was eaten 3 days prior to measurements of variables.
16109435|NCT02093481|Other|No priming|The reference or test meal was eaten 1 days prior to measurements of variables.
16109436|NCT02093468|Drug|MST-188|
16109437|NCT02093468|Drug|Saline|
16109438|NCT02093455|Dietary Supplement|Chardonnay Seed Flour (CSF)|CSF is made from wine grape skins and seeds.
16109439|NCT02093455|Dietary Supplement|Placebo|
16109440|NCT02093442|Procedure|Endometrial injury|Endometrial biopsy using a pipelle de Cornier
16109441|NCT02093429|Drug|INCB047986|INCB047986 will be supplied as tablets.
16109442|NCT02093403|Drug|decitabine|Given IV
16109443|NCT02093403|Drug|selinexor|Given PO
16109444|NCT02093403|Other|pharmacological study|Correlative studies
16109445|NCT02093403|Other|laboratory biomarker analysis|Correlative studies
16109446|NCT02093390|Drug|TAK-385|TAK-385 tablets
16109447|NCT02093390|Drug|Fluconazole|Fluconazole tablets
16109448|NCT02093390|Drug|Atorvastatin|Atorvastatin tablets
16109449|NCT02093377|Device|Adaptive servo-ventilation|Adaptive servo-ventilation (ASV, most recent technology of AutoSetCS device, ResMed, Sydney, Australia)
16109450|NCT02093351|Drug|Olaparib|2 x 150mg tablets, twice daily Day 1-5, and Day 27 onwards (Cohort 1), Day 20 onwards (Cohort 2) or Day 39 onwards (Cohort 3)
16109451|NCT02093351|Drug|Tamoxifen|60mg Tamoxifen once daily, Day 10 - Day 13; 20mg Tamoxifen once daily, Day 14 - Day 31
16109452|NCT02093351|Drug|Anastrozole|1mg Anastrozole once daily Day 10 - Day 24
16109453|NCT02093351|Drug|Letrozole|2.5mg Letrozole once daily Day 10 - Day 43
16109454|NCT02093351|Procedure|Pharmacokinetic sampling|Blood sampling over 12-24 hour period for pharmacokinetic analysis
16109455|NCT02093338|Dietary Supplement|Lactobacillus fermentum CECT5716|
16109456|NCT02093338|Other|Placebo Comparator: maltodextrin|Placebo
16109457|NCT02093325|Drug|Eltrombopag|This will be a Phase III, randomized, double-blind, placebo-controlled clinical trial. Qualified subjects will be randomly assigned to receive either the test treatment or the placebo at 2:1 ratio. Once subjects are randomized, they will be treated with Arm A: Eltrombopag 50 mg/day (n=55) or Arm B: placebo (n=28) once a day for 7 days.
16109458|NCT02093325|Drug|Placebo|This will be a Phase III, randomized, double-blind, placebo-controlled clinical trial. Qualified subjects will be randomly assigned to receive either the test treatment or the placebo at 2:1 ratio. Once subjects are randomized, they will be treated with Arm A: Eltrombopag 50 mg/day (n=55) or Arm B: placebo (n=28) once a day for 7 days.
16109459|NCT02093312|Dietary Supplement|Home food-delivery service|A home food-delivery service is offered the intervention group of cancer patients
16109460|NCT02093299|Drug|Clopidogrel|a blood sample is drawn on all patients to determine responder status
16109461|NCT02093273|Biological|tOPV pilot batch|the tOPV vaccine is given orally
16109462|NCT02093273|Biological|tOPV commercial batch|tOPV vaccine is given orally
16109463|NCT02093260|Biological|Vaccine|"Flubio (Influenza HA) Vaccine
~The vaccine will be given intramuscularly."
16109464|NCT02093234|Behavioral|mobile health care application|mobile health application for cell phones to assist patients in managing their diabetes.
16109465|NCT02093234|Behavioral|CHWs and mobile health care application|CHWs will assist diabetic patients in managing their health in conjunction with the mobile health care application.
16109466|NCT02093234|Behavioral|Community Health Worker (CHW)|CHWs assist patients in managing their diabetes in various ways.
16109467|NCT02093221|Biological|180 mg/kg Alpha1-PI|
16109468|NCT02093221|Biological|90 mg/kg Alpha1-PI|
16109469|NCT02093221|Biological|Placebo|
16109470|NCT02093195|Drug|Bosentan|
16109474|NCT02093156|Other|Bowel preparation instructions|The same-day preparation method was used as previously reported. Briefly, all patients were instructed to have a regular diet for breakfast and lunch, but only clear liquids for dinner on the day before the colonoscopy. They were asked to drink two bags of PEG-ELP (polyethylene glycol electrolyte powder) dissolved in 2 L of water, or 45 mL of sodium phosphate be diluted in 240 mL of cool water follow with at least 1.5 L of water at 05:00-06:00 h within 2 h on the day of colonoscopy. Patients were encouraged to drink more clear liquids after purgatives for adequate hydration before colonoscopy.
16109475|NCT02093143|Drug|Remifentanil|Target-controlled infusion of remifentanil 50 µg/ml using the pharmacologic model of Minto et al. to achieve a theorical brain concentration of 1.5 ng/ml.
16109476|NCT02093130|Dietary Supplement|Pomegranate Juice|
16109477|NCT02093130|Dietary Supplement|Placebo|
16109478|NCT02093117|Procedure|Recruitment maneuver|continuous positive airway pressure of 30 cm of water for 30 seconds
16109479|NCT02093117|Procedure|Sham recruitment maneuver|Continuous positive airway pressure of 5 cm of water for 30 seconds
16109480|NCT02093091|Procedure|Dental caries was removed from primary molars and was filled with the recent filling material; Ketac Nano.|Class I carious primary molars were selected. Dental caries was removed and cavities were prepared. The recent nano-filled RMGI filling (Ketac Nano) was used to fill these cavities.
16109481|NCT02093091|Procedure|Dental caries was removed from primary molars and was filled with the conventional filling material;Vitremer|Class I carious primary molars were selected. Dental caries was removed and cavities were prepared. The conventional RMGI filling (Vitremer) was used to fill these cavities.
16109482|NCT02093078|Behavioral|CARD|"Intervention: CARD
~This group will be introduced to the CARD protocol which focuses on clarification of individual roles and distribution of tasks. It relies on large identification cards specially designed for each team member's profession and role. Each card worn by a team member identifies the specific tasks associated with that individual's role. CARD enables the team leader and other team members to quickly recognize everyone's role at the code, and each team member can commence their assigned tasks without delay."
16109483|NCT02093052|Behavioral|Attachment and Biobehavioral Catch-up|Enhance nurturance and following the lead among parents. In-home intervention with parents and children present.
16109484|NCT02093052|Behavioral|Developmental Education for Families|Enhance children's cognitive development. In-home intervention with parents and children present.
16109485|NCT02093039|Device|decision aid group|The paper-based leaflet DECIDEO is a 12-page pocket leaflet providing scientific information about the advantages and disadvantages of participating in the national breast screening program, understandable by all, constructed to conform with the International Patient Decision Aid Standards
16109486|NCT02093026|Drug|Rituximab|Participants will receive rituximab 1 gram IV on Days 1 and 15 of each course of retreatment.
16109487|NCT02093026|Drug|Methotrexate|Participants will receive methotrexate 10-25 mg/week orally or parenterally.
16109488|NCT02093026|Drug|Methylprednisolone|Participants will receive methylprednisolone 100 mg IV 30 minutes prior to each rituximab infusion.
16109489|NCT02093026|Drug|Folic Acid|Participants will receive folic acid >= 5 mg/week or equivalent.
16109490|NCT02093013|Other|Integrated care program|Integrated care program meant in effect, calling on the family medicine group (FMG) nurses to evaluate and support asthmatic patients. The FMG and asthma education centre (AEC) nurses received special training and followed a protocol based on the theoretical model and the Canadian asthma management recommendations then in force. The protocol had five main aspects: 1) asthma assessment, 2) self-management, 3) environment and lifestyle, 4) collaborative care plan, and 5) information sharing and follow-up.
16109491|NCT02093000|Drug|Bevacizumab|Participants will receive bevacizumab 7.5 milligrams per kilograms (mg/kg) intravenously according to bevacizumab summary of product characteristics/local labeling.
16109492|NCT02092987|Other|Social work support|All study participants were provided access to social support services at Riverstone Senior Life services
16109493|NCT02092987|Other|Educational material|All participants received educational material about dementia and caregiving in addition to information about resources for persons with dementia and their caregivers, including resources at the Alzheimer's Association such as support groups, and clinical and service resources available citywide.
16109494|NCT02092987|Behavioral|NYU caregiver counseling intervention|"The first component consists of 2 individual and 4 family counseling sessions. These sessions last between 1 and 1.5 hours. The second component of the intervention is participation in a caregiver support group . The third component of the treatment is ad hoc counseling. New psychiatric and behavioral problems of patients, which are generally more stressful than the need for assistance with activities of daily living or physical limitations, often precipitate ad hoc calls from caregivers."
16109495|NCT02092987|Behavioral|REACH OUT counseling intervention|All aspects of the REACH OUT Intervention involve problem solving techniques and the development of written action plans. The goal of this intervention is to engage the caregiver in joint problem-solving with the objective of creating a written action plan targeting specific caregiving problems. The basic steps of problem solving are: 1.Define the problem. 2. Set goals 3. Brainstorm with caregiver and List possible solutions on a pad of paper, 4. Select solutions, 5. Develop an action plan based on these solutions, 6. Implement the action plan, track progress, and make adjustments as needed
16109496|NCT02092974|Procedure|tDCS|
16109497|NCT02092974|Drug|Citalopram|
16109498|NCT02092974|Other|sham-tDCS + placebo|
16109499|NCT02092961|Drug|Fostamatinib|Fostamatinib 100mg twice daily.
16109500|NCT02092961|Drug|Adalimumab|Adalimumab 40 mg by subcutaneous injection every 2 weeks for 24 weeks.
16109501|NCT02092961|Drug|Placebo of Fostamatinib|Placebo bid for 6 weeks.
16109502|NCT02092961|Drug|Placebo of Adalimumab|Placebo injection once every two weeks.
16109503|NCT02092948|Radiation|[124I] PSCA-Minibody PET/CT imaging of the whole body|Whole body Imaging
16109504|NCT02092935|Drug|SMT19969|
16109505|NCT02092935|Drug|Vancomycin|
16109506|NCT02092922|Drug|Filanesib, KSP (Eg5) inhibitor; intravenous|multiple dose, single schedule
16109507|NCT02092922|Drug|Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous|standard of care
16109508|NCT02092909|Drug|IMO-8400|IMO-8400 at escalating dose levels by subcutaneous injection
16109549|NCT02092597|Drug|Gliclazide|
16109509|NCT02092896|Drug|Liraglutide|Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 1 is performed.
16109510|NCT02092896|Drug|Placebo|Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 1 is performed.
16109511|NCT02092896|Drug|Liraglutide|Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 2 is performed.
16109512|NCT02092896|Drug|Placebo|Subjects randomised to 1.2 mg liraglutide treatment or liraglutide placebo will receive 0.6 mg for 1 weeks followed by 1.2 mg for 11 weeks. At baseline and week 12 study 2 is performed.
16109513|NCT02092883|Drug|ACTH|PK PET scan before and after ACTH treatment
16109514|NCT02092870|Drug|Adipose derived stem cells|ASCs harvested from autologous lipoaspirate
16109515|NCT02092857|Dietary Supplement|Arachidonic acid (25 mg/100 kcal )|
16109516|NCT02092857|Dietary Supplement|Arachidonic acid (34 mg/100 kcal)|
16109517|NCT02092857|Dietary Supplement|Placebo|10 weeks exclusive infant formula feeding (without supplemental arachidonic acid).
16109518|NCT02092844|Behavioral|CBT for Menopausal Insomnia (CBTMI)|Cognitive Behavioral Therapy for Menopausal Insomnia (CBTMI) includes education about sleep, sleep restriction, stimulus control, cognitive restructuring of sleep interfering thoughts, and relapse prevention; while also addressing women's beliefs about and reactions to hot flashes.
16109519|NCT02092831|Drug|GDC-0941|Single dose market image tablet of hardness 1
16109520|NCT02092831|Drug|GDC-0941|Single dose market image tablet of hardness 2
16109521|NCT02092831|Drug|GDC-0941|Single dose market image tablet of hardness 3
16109522|NCT02092831|Drug|GDC-0941|Single dose Phase 2 tablet formulation
16109523|NCT02092818|Drug|Riociguat (Adempas, BAY63-2521)|The decision on clinical management of the patient including the actual treatment duration will be determined solely by the physician not by the clinical study protocol (CSP)
16109524|NCT02092805|Procedure|Real rTMS(20 Hz, 10 trains, inter train interval 30 sc with total pulses 2000, intensity 80% of motor threshold) daily for 10 consecutive days (5 days/week)|
16109525|NCT02092805|Procedure|Sham rTMS (same parameters but with coil elevated and angled away from the head) every day for 10 consecutive days (5 days/week).|
16109526|NCT02092792|Drug|DLYE5953A|Escalating doses of DLYE5953A
16109527|NCT02092792|Drug|DLYE5953A|Administration of DLYE5953A at the recommended phase II dose (RP2D)
16109528|NCT02092766|Drug|artesunate|
16109529|NCT02092766|Drug|quinine|
16109530|NCT02092753|Other|Standard diet (SD)|Nutrition intervention following the recommendations of the germans society for nutrition (DGE)
16109531|NCT02092753|Other|Experimental 1: Ketogenic diet (KD).|Nutritional intervention: recommendations to follow a ketogenic diet
16109532|NCT02092753|Other|"Experimental 2: Low glycämic and insulinemic diet (LOGI)"|"Nutritional intervention: patients were instructed to follow the LOGI diet regimen"
16109533|NCT02092727|Behavioral|Behavioral Interventions for Dialysis Facilities|"Educational seminars and monthly educational webinars
~Peer-to-peer mentoring program
~Bulletin boards about transplantation
~Facility-specific feedback reports detailing transplant referral data for their center compared to state average
~Formulate a facility-specific improvement plan to increase transplant referrals.
~Requirement to form a Patient and Family Advisory Group to increase outreach about transplant education within the facility.
~Monthly monitoring and reporting of patient referrals to ESRD Network
~Conduct a patient and family education session about transplantation
~Host a movie day to show Living ACTS (About Choices in Transplantation & Sharing) video"
16109534|NCT02092714|Other|laboratory biomarker analysis|Correlative studies
16109535|NCT02092701|Drug|Cholecalciferol|
16109536|NCT02092688|Device|novel kit for the detection of PAMG-1|The novel kit for the detection of PAMG-1 is a diagnostic device employing monoclonal antibodies that detect Placental α1 Microglobulin present in cervico-vaginal secretions manufactured by AmniSure® International, LLC, Boston, MA. The in vivo sensitivity detection threshold is 4ng/ml. During the test procedure, PAMG-1 from the sample sequentially binds to monoclonal antibody conjugated with labeled particles, then to monoclonal antibody immobilized on an insoluble carrier. The test requires a 30 second swab saturation in the vagina (a sterile speculum examination is not required), a 30 second active washing step whereby the swab just removed from the vagina is actively rotated in a solvent filled vial and lastly, a 5 minute waiting period from the time the swab is removed and the test strip is inserted if two testing lines do not appear sooner.
16109537|NCT02092662|Other|stroke|task-oriented therapy: physical and occupational therapy emphasizing integration of the patients needs, environment and context
16109538|NCT02092662|Other|Healthy controls|no treatment
16109539|NCT02092649|Dietary Supplement|Omega-3 Complete|
16109540|NCT02092649|Dietary Supplement|Placebo Pill|
16109541|NCT02092636|Other|NIR/US Diagnostic Group|Patients receiving an ultrasound-guided biopsy will participate in one study visit on the day of the biopsy. The NIR/US scan will be completed immediately prior to the biopsy procedure and takes about 5-10 minutes to perform.
16109542|NCT02092636|Other|NIR/US Neoadjuvant Chemotherapy Group|Patients may have the NIR/US scan performed at the time of their initial ultrasound-guided biopsy. In addition, patients in this group may also have NIR/US performed according the schedule in Table 1. The number of NIR/US study visits for these subjects will vary from 1-11 depending on the subject's treatment regimen. The expected duration of study participation for these patients is approximately 6 months.
16109543|NCT02092636|Other|NIR/US Process Validation Group|Patients who present with visible lumps at initial ultrasound but do not have ultrasound visible lumps on the day of the biopsy procedure will not require a biopsy. NIR/US scan will be performed. Data from the NIR/US scan will be used to validate instrument measurements.
16109544|NCT02092623|Device|Transvaginal posterior mesh|A trocar-free fixation system with low-weight mesh
16109545|NCT02092610|Device|Novel Implant BI300|The Novel Implant BI300 was the new titanium implant and abutment for the Baha system developed by Cochlear Bone Anchored Solutions AB. The novel implant is 4.5 mm wide and 4.0 mm long.
16109546|NCT02092610|Device|Standard Implant BI300|The Standard Implant BI300 was the standard titanium implant and abutment in the Baha system developed by Cochlear Bone Anchored Solutions AB. The implant is 3.75 mm wide and 4.0 mm long
16109551|NCT02092584|Dietary Supplement|Placebo|4 cap 1 g Placebo(paraffin) per day for 2 months
16109552|NCT02092571|Drug|Progesterone vaginal ring,|Participants will be randomized to receive treatments in 1 of 2 treatment sequences (AB or BA)
16109553|NCT02092558|Drug|Second-generation cephalosporin, nitrofurantoin, 1% aminoglycoside solution|
16109554|NCT02092558|Drug|cephalosporin with chemotherapeutics|Second-generation cephalosporin was prescribed for 10 days, and then treatment crossover with chemotherapeutics in therapeutic dose (change in every week) during 3 months
16109555|NCT02092545|Other|Ketogenic diet|
16109556|NCT02092532|Drug|Rescue Intravitreal Aflibercept Injection|Patients can receive additional IAI treatment (Months 3, 5, 7, 9, and 11) if the re-treatment criteria are met.
16109557|NCT02092532|Procedure|Rescue Therapy with PDT, Laser or Intravitreal Steroids|Starting at Month 3, patients can receive non-anti VEGF rescue therapy (ie: PDT, laser, intravitreal steroids) if the pre-defined criteria are met.
16109558|NCT02092519|Device|Needle with sideport (NA-230H-8020)|EUSFNA using needle with sideport
16109559|NCT02092519|Device|Needle without sideport (NA-220H-8022)|EUSFNA using needle without sideport
16109560|NCT02092506|Drug|10 day triple therapy|10 day triple therapy
16109561|NCT02092506|Drug|10 day sequential therapy|10 day sequential therapy
16109562|NCT02092506|Drug|10 day concomitant therapy|10 day concomitant therapy
16109563|NCT02092493|Device|ScopeGuide|These patient will have their procedure undertake with the use of ScopeGuide, which provides a 3d configuration of the colonoscope in the patient
16109564|NCT02092480|Behavioral|If I Were Jack|The If I Were Jack intervention is a classroom-based RSE resource designed to be delivered by teachers over four weeks. It is composed of: (i) An interactive video drama which asks pupils to put themselves in Jack's shoes and consider how they would feel and what they would do if they were Jack; (ii) Classroom materials for teachers containing detailed lesson plans with specific classroom-based and homework activities; (iii) 60-minute training session for teachers wishing to implement the intervention; (iv) 60-minute information and discussion session for parents/guardians delivered by RSE teachers; (v) Brochures and factsheets about the intervention and unintended teenage pregnancy for schools, teachers, teacher trainers, young people and parents.
16109565|NCT02092467|Drug|tofacitinib|Oral tablet, 5 mg BID
16109566|NCT02092467|Drug|tofacitinib|Oral tablet, 10 mg BID
16109567|NCT02092467|Biological|adalimumab|Pre-filled syringe, 40 mg subcutaneous injection, every other week
16109568|NCT02092467|Biological|etanercept|Pre-filled syringe, 50 mg subcutaneous injection, every week
16109569|NCT02092454|Drug|Benzocaine|topical otic solution
16109570|NCT02092454|Drug|Placebo|topical otic solution
16109571|NCT02092441|Other|Alcohol prep pad group|Subjects inhale scent of alcohol pad
16109572|NCT02092441|Other|Normal Saline prep pad|Subjects inhale scent of placebo (normal saline) pads
16109573|NCT02092428|Other|Image Quality|"The following procedures may be conducted as part of this study:
~Coronary MRI scan with no contrast
~Coronary MRI scan enhanced with a gadolinium-based contrast agent (Optimark, MultiHance, Ablavar) administered intravenously at a total dose of up to 0.2 mmol/kg
~MRI scan with an oral beta blocker (metoprolol)
~Cardiac Stress Test MRI scan with a pharmacologic stress drug; either adenosine (dosage depends on the subject's weight and is set at 140mcg/kg/min) or regadenoson (0.4mg/5ml bolus)
~Determination of study drugs will be made depending upon study focus, subjects' health conditions, blood pressure, heart rate and concomitant medications. Both groups are eligible for all combinations of interventions."
16109574|NCT02092428|Other|Diagnostic Accuracy|Both groups are eligible for all combinations of interventions. This arm will also include collection of conventional x-ray angiography.
16109575|NCT02092415|Device|Application of a Junctional Tourniquet|All subjects will be studied at baseline and after placement of a junctional tourniquet to the femoral artery.
16109576|NCT02092402|Other|Fecal transplantation|
16109577|NCT02092376|Drug|Cholecalciferol|
16109578|NCT02092376|Drug|Placebo|
16109579|NCT02092363|Drug|OMP-54F28, Paclitaxel and Carboplatin|
16109580|NCT02092350|Drug|Grazoprevir|Grazoprevir 100 mg tablet
16109581|NCT02092350|Drug|Elbasvir|Elbasvir 50 mg tablet
16109582|NCT02092350|Drug|Placebo to Grazoprevir|Placebo tablet matched to grazoprevir
16109583|NCT02092350|Drug|Placebo to Elbasvir|Placebo tablet matched to elbasvir
16109584|NCT02092337|Other|computer-assisted speech training|
16109585|NCT02092324|Other|Laboratory Biomarker Analysis|Correlative studies
16109586|NCT02092324|Other|Quality-of-Life Assessment|Ancillary studies
16109587|NCT02092324|Other|Questionnaire Administration|Ancillary studies
16109588|NCT02092324|Drug|Ruxolitinib Phosphate|Given PO
16109589|NCT02092311|Procedure|Combined Microscopic Varicocelectomy|After making a mini-incision at inguinal level, veins are evaluated, and if the including criteria (Complexity and tortuosity of the veins and/or existence of veins that are contiguous with arteries so that separating and ligation of the veins could jeopardize the artery) are existed, only external spermatic vein, if dilated, is ligated at the depth of the inguinal canal, and other veins are left alone for prevention of damage to the artery. Subsequently, another mini-incision is made at high inguinal level and the rest of surgery is conducted by retroperitoneal approach, which is also done microscopically
16109590|NCT02092311|Procedure|Inguinal and Subinguinal varicocelectomy|Microscopic Inguinal and Sub inguinal varicocelectomy, recommended by Goldstein and associates, are currently popular approaches. In this approach the spermatic cord structures are pulled up and out of the wound so that the testicular artery, lymphatics, and small periarterial veins may be more easily identified. In addition, an inguinal or subinguinal approach allows access to external spermatic and even gubernacular veins.
16109591|NCT02092298|Drug|Mitomycin C|Mitomycin C 30 mg delivered laparoscopically for 60 minutes.
16109592|NCT02092298|Drug|Cisplatin|Cisplatin 200 mg delivered laparoscopically 60 minutes, 2-8 weeks after completion of systemic chemotherapy.
16109593|NCT02092298|Drug|Sodium Thiosulfate|Loading dose of 7.5 gm/M2 of Sodium Thiosulfate infused prior to addition of Cisplatin to the peritoneal perfusion circuit. Then a maintenance infusion of Sodium Thiosulfate 25.56 gm/M2 delivered by continuous infusion pump over 12 hours.
16109594|NCT02092285|Drug|Golimumab|50mg or 100mg solution for injection; subcutaneous injection
16109595|NCT02092272|Behavioral|instructional exercise video source|instructional exercise video source
16109596|NCT02092246|Device|Ultrasound machine|Use of ultrasound machine guidance for accurate needle placement into the knee joint
16109597|NCT02092246|Device|Unguided injection|Needle placement will take place without ultrasound machine guidance
16109598|NCT02092220|Device|Bionic Pancreas|
16109599|NCT02092220|Device|Insulin pump with or without CGM|
16109600|NCT02092207|Drug|KL7016 900mg|oral administration, 150mg 3tab, bid
16109601|NCT02092207|Drug|KL7016 600mg|oral administration, 150mg 3tab, bid
16109602|NCT02092207|Drug|Placebo|oral administration, 150mg 3tab, bid
16109603|NCT02092194|Procedure|High Dose Online HDF|Convection volume; 33-43 L/treatment (140-180 mL/min)
16109604|NCT02092194|Procedure|Standard Dose Online HDF|convection volume; 16.8-21.5 L/treatment (70-90 mL/min)
16109605|NCT02092181|Drug|Mirabegron|25 mg po daily for 32-40 days. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
16109606|NCT02092181|Drug|Placebo|Placebo 25 mg po daily. Following up-titration to 50 mg po daily. This is pending no adverse events on the 25 mg dose.
16109607|NCT02092168|Drug|BIA 9-1067|
16109608|NCT02092142|Biological|Q fever Vaccine|Subcutaneous 0.5 mL Q fever Vaccine, Phase I, Inactivated, Dried, NDBR 105
16109609|NCT02092116|Drug|Romidepsin|Latency reversing agent
16109610|NCT02092116|Biological|Vacc-4x|Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
16109611|NCT02092116|Biological|rhuGM-CSF|Granulocyte macrophage colony stimulating factor as a local adjuvant
16109612|NCT02092103|Procedure|Cord Milking|See description in cord milking arm.
16109613|NCT02092090|Behavioral|Dietary sodium reduction|Ongoing dietary advice and a supply of a reduced-sodium added-potassium salt substitute
16109614|NCT02092077|Drug|TV-1106|TV-1106 0.554mg, TV-1106 0.924 mg, TV-1106 1.20 mg
16109615|NCT02092077|Drug|somatropin|Dose may be adjusted as required
16109616|NCT02092051|Device|Continuous glucose monitoring with DexCom G4 platina|
16109617|NCT02092038|Drug|Temozolomide|Neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.
16109618|NCT02092038|Radiation|partial brain irradiation|Neoadjuvant treatment with concurrent temozolomide and radiation therapy, followed by surgery and then further temozolomide.
16109619|NCT02092038|Procedure|stereotactic biopsy of brain tumor|will be assessed for tumor type and tumor markers
16109620|NCT02092038|Procedure|craniotomy and tumor resection|maximal safe resection
16109621|NCT02092025|Drug|Azilsartan|Azilsartan tablets
16109622|NCT02092012|Drug|dexketoprofen trometamol|ıv 50 mg dexketoprofen trometamol after anaesthesia induction
16109623|NCT02092012|Drug|Dexmedetomidine|ıv 1 mcg/kg dexmedetomidine after anaesthesia induction
16109624|NCT02091999|Drug|enfortumab vedotin|intravenous (IV) infusion
16109625|NCT02091986|Drug|Symbicort pMDI|Budesonide/formoterol pMDI 80/2.25 µg, 2 acuations twice daily
16109626|NCT02091986|Drug|Symbicort pMDI|Budesonide/formoterol pMDI 80/4.5µg, 2 acuations twice daily
16109627|NCT02091986|Other|Budesonide pMDI|Budesonide pMDI 80µg, 2 acuations twice daily
16109628|NCT02091973|Drug|Everolimus|Everolimus dosing to target tough level 6-10 mg/ml
16109629|NCT02091973|Drug|Tacrolimus|Tacrolimus dosing to target tough level 5-10 ng/ml
16109630|NCT02091960|Drug|Enzalutamide|Capsules for oral administration
16109631|NCT02091960|Drug|Trastuzumab|Intravenous infusion (IV) or subcutaneous injection if it is standard of care within a country
16109632|NCT02091947|Device|FMS (Magstim rapid2)|5 Hz FMS, over bilateral sacral roots.
16109633|NCT02091934|Procedure|Wavefront-guided PRK|Wavefront-guided PRK
16109634|NCT02091934|Procedure|Wavefront-optimized PRK|Wavefront-optimized PRK
16109635|NCT02091921|Drug|Ticagrelor|All patients will be switched from clopidogrel to ticagrelor 90 mg twice daily for two weeks and the VerifyNow and VASP platelet reactivity assays repeated, samples will be collected before and 6±1 hours after the last ticagrelor dose.
16109636|NCT02091908|Biological|Novartis Investigational H5N1 vaccine|2 doses of 0.5 ml, 3 weeks apart
16109637|NCT02091908|Biological|Novartis Investigational H5N1 vaccine|2 doses of 0.5 ml, 3 weeks apart
16109638|NCT02091908|Biological|Novartis Seasonal Influenza Vaccine|2 doses of 0.5 ml, 3 weeks apart
16109639|NCT02091908|Biological|Novartis Seasonal Influenza Vaccine|2 doses of 0.5 ml, 3 weeks apart
16109640|NCT02091895|Procedure|probe-based confocal laser endomicroscopy|"After shooting 10% fluorescein sodium in,2.5-5 .0 ml to the object with colorectal disease, the lesion will observed and evaluated with pCLE in real-time and also stored the inspection images.
~Then, determines the treatment plan to determine which is applied currently in clinical, Sensitivity, specificity, accuracy, amphoteric predict of pCLE diagnosis, and calculate the agreement of prediction compared to the pathological findings of lesions Based on the inspection image stored, using Delphi approach tests, two or more are discussed, to derive a significant technical phrases.
~Check diagnostic agreement of technical phrases which are derived, the matching degree between observers, and developed a new classification method based on this."
16109642|NCT02091869|Other|Paper Asthma Action Plan|Participants will utilize a paper based asthma action plan to record asthma symptoms and medication usage.
16109643|NCT02091869|Device|Mobile Phone|Participant will be able to log peak flow data, medications, and symptoms in their mobile phones utilizing the mobile app.
16109742|NCT02091141|Drug|Cobimetinib|Cobimetinib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
16109644|NCT02091856|Behavioral|Cognitive Behavioral Therapy (CBT)|Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Positive CBT intervention includes set of exercises devised from the positive psychology paradigm. Similarly, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief.
16109645|NCT02091843|Procedure|DBS of the Basolateral Nucleus of the Amygdala|
16109646|NCT02091843|Device|Medtronic Activa PC DBS of the Basolateral Nucleus of the Amygdala|
16109647|NCT02091830|Drug|Paracetamol and nonsteroidal antiinflammatory drug (NSAID)|
16109648|NCT02091830|Other|Physiotherapy|
16109649|NCT02091830|Drug|Cortisone Injection|
16109650|NCT02091830|Other|Others|
16109651|NCT02091817|Drug|Oxytocin|Intervention will be examined on control group, and on experimental group as well.
16109652|NCT02091817|Drug|Placebo|Placebo will be given to control group and experimental group as well.
16109653|NCT02091804|Behavioral|Immediate Group|"The intervention consists of delivering the Promoting First Relationship (PFR) program. PFR comprises 10 sessions and lasts approximately 12 weeks. Each session lasts approximately 30 minutes, and begins with brief (~10 min) discussions and education on the target topic for that week . The remaining 20 minutes will alternate between video recording a structured interaction between the caregiver and child or viewing the previous session's recording and engaging in reflective discussion about successful caregiving strategies and child's response to caregiver behavior. Trained PFR specialists who are community members use the 5 consultation strategies, labeled Joining, Positive Feedback, Instructive Feedback, Reflective Questions and Comments, and Instruction with Handouts."
16109654|NCT02091804|Behavioral|Wait-List group|"The intervention consists of delivering the Promoting First Relationship (PFR) program. PFR comprises 10 sessions and lasts approximately 12 weeks. Each session lasts approximately 30 minutes, and begins with brief (~10 min) discussions and education on the target topic for that week . The remaining 20 minutes will alternate between video recording a structured interaction between the caregiver and child or viewing the previous session's recording and engaging in reflective discussion about successful caregiving strategies and child's response to caregiver behavior. Trained PFR specialists who are community members use the 5 consultation strategies, labeled Joining, Positive Feedback, Instructive Feedback, Reflective Questions and Comments, and Instruction with Handouts."
16109655|NCT02091791|Procedure|Traction sessions|
16109656|NCT02091778|Device|Fast gelling dressing|
16109657|NCT02091765|Behavioral|Internet-based cognitive behavioral therapy.|
16109658|NCT02091752|Drug|Ruxolitinib|Starting dose was based on reason for previous discontinuation of ruxolitinib (i.e. loss of response or AE) and baseline platelet count. For participants who previously discontinued ruxolitinib due to loss of response, the starting dose was determined based on baseline platelet counts as follows: participants with a baseline platelet count of ≥ 200 x 109/L began dosing at 20 mg po bid; participants with a baseline platelet count of 100 x 109/L to <200 x 109/L began dosing at 15 mg po bid. Participants who previously discontinued ruxolitinib due to an AE initiated therapy at a total daily dose 5 mg lower than the total daily dose prior to discontinuation.
16109659|NCT02091739|Drug|IncobotulinumtoxinA (100 Units)|Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
16109660|NCT02091739|Drug|IncobotulinumtoxinA (75 Units)|Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
16109661|NCT02091739|Drug|Placebo|Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
16109662|NCT02091726|Procedure|Unicirc instrument plus cyanoacrylate tissue adhesive|Volunteers will be circumcised using the Unicirc surgical instrument and the incision will be sealed using cyanoacrylate tissue adhesive
16109663|NCT02091713|Other|Functional movement screen|The subjects will undergo movement and balance screens, measures of power, demographic data and biopsychosocial measures. Injury data will be collected through physician exam, self-report, profile data, and healthcare utilization data. Injury data will be collected at baseline and for six iterations, every 60 days, over the course of one year following baseline. Based on the data collected, clinical prediction rules will be used to develop computerized algorithm to predict injury risk in these populations.
16109664|NCT02091700|Other|Indocyanine Green ICG|
16109665|NCT02091674|Device|Hyaluronic acid|Injected gel
16109666|NCT02091661|Procedure|Radical retropubic prostatectomy|The surgery arm underwent radical retropubic prostatectomy, performed by a technique described by Walsh. The prostatectomy is performed in retrograde way, preserving the neurovascular bundles if feasible. The degree to which the surgeon preserve the nerves is categorized as non-nerve-sparing, unilateral nerve-sparing, or bilateral nerve-sparing. Pelvic lymph node dissection is performed if feasible. The operative time is about 2 to 3 hours and required hospital stay. The patient has a urinary catheter placed for 6 to 9 days to facilitate bladder emptying.
16109667|NCT02091661|Radiation|External beam radiotherapy|External beam radiotherapy is carried out with intensity-modulated radiation technique. The treatment is designed to maximize the radiation dose to the prostate and seminal vesicles and minimize exposure to surrounding structures, including the bladder and rectum. Radiation to the prostate was delivered in fractionated doses divided over multiple treatments (180 to 200 centigray (cGy) daily fractions, 5 days per week) for a total dose to the prostate of 68 to 77 gray (Gy), prescribed at 90% to 100% of the isodose line.
16109668|NCT02091648|Behavioral|I Can Cope Intervention|"Participants randomized to the I Can Cope condition will receive 6 face-to-face individualized sessions over a 2-month period. Each session will last 50 minutes and take place at the child's school either during approved times during the school day or as part of the after-school program. Sessions are psychoeducational and experiential and include opportunities for the child with asthma to: (1) learn about the pathophysiology of asthma; (2) understand the biological impact of stress on the body; (3) learn the relationship among thoughts, feelings, actions, and asthma; (4) acquire a set of coping skills to help deal with asthma-related and day-to-day stressors in their lives, and (5) receive training in biofeedback-assisted relaxation techniques."
16109870|NCT02089958|Procedure|Laparoscopic incisional hernia repair|Standardized laparoscopic incisional hernia repair with mesh
16109669|NCT02091648|Behavioral|Standard Education Intervention|"This group will receive the standard American Lung Association (ALA)Open Airways for Schools program. This program includes six 40-minute sessions covering the National Heart Lung and Blood Institute's recommendations for asthma education."
16109670|NCT02091635|Drug|Placebo (for Motilitone)|Eligible subjects were randomly allocated in a 1 : 1 ratio to receive either 60 mg motilitone (motilitone group) or placebo (placebo group) three times daily (before meals) for 5 days (days 1-5).
16109671|NCT02091635|Drug|Motilitone|Eligible subjects were randomly allocated in a 1 : 1 ratio to receive either 60 mg motilitone (motilitone group) or placebo (placebo group) three times daily (before meals) for 5 days (days 1-5).
16109672|NCT02091622|Other|Educative intervention|Two municipalities (in charge of nursing homes) and two hospitals were randomized to receive an interactive half-day course about ITEOL for physicians and nurses.
16109673|NCT02091609|Other|dental interproximal brush|use of this to maintain oral hygiene
16109674|NCT02091609|Other|dental floss|use of this to maintain oral hygiene
16109675|NCT02091596|Drug|PluroGel N|Study Drug
16109676|NCT02091596|Drug|PluroGel|PluroGel Vehicle Placebo Comparator
16109677|NCT02091583|Dietary Supplement|Butter, sunflower and safflower oil|
16109678|NCT02091583|Dietary Supplement|High Oleic Canola Oil and DHA (HOCO-DHA)|
16109679|NCT02091583|Dietary Supplement|Barley beta-glucan|
16109680|NCT02091583|Dietary Supplement|HOCO-DHA and Barley beta-glucan|
16109681|NCT02091570|Other|Nutrition Bar|Intervention involves consumption of one nutrition bar of approximately 50 g in the beginning of each visit of the crossover sequence
16109682|NCT02091557|Drug|GnRH-analogue|
16109683|NCT02091544|Other|Lifestyle intervention|
16109684|NCT02091531|Drug|MLN0128|
16109685|NCT02091518|Behavioral|MR Screening Questionnaire|All participants will complete the MR Screening Questionnaire before the MRI exam. During the MRI exam, all participants will be observed through the window from the operator console. Verbal communication will be kept with the participant throughout the exam via a speaker system.
16109686|NCT02091518|Device|Magnetic Resonance Imaging Acquisition and Analysis|MRI Studies: The MRI scans will be performed on a 1.5T or 3T MRI scanner. Conventional MRI studies will be performed using the standard clinical sequences. The new research sequences will be performed.at any point during the clinical exam. Total imaging time for volunteers will be 30-45 minutes.
16109687|NCT02091505|Drug|Ranibizumab|
16109688|NCT02091492|Drug|Teriparatide|Teriparatide 20 µg sc (subcutaneous injection) each day for 12 weeks
16109689|NCT02091492|Drug|Placebo|Placebo teriparatide sc (subcutaneous injection) each day for 12 weeks
16109690|NCT02091479|Drug|UFH Early group|"Either curative dose, intravenous unfractionated heparin (UFH) so as to reach an anti-Xa activity between 0.3 and 0.7 IU/mL, lengthening the activated prothrombin time as determined by each centre according to the treatment area (depending on the coagulometer and reactants).
~Or low-molecular-weight, curative dose, subcutaneous heparin (LMWH) so as to reach an anti-Xa activity corresponding to treatment areas as determined for each type of molecule (about 0.5 to 1 anti-Xa IU for most LMWHs, administered via 2 daily injections, and about 0.5 to 1.5 anti-Xa IU for tinzaparin, 1 injection daily)."
16109691|NCT02091479|Drug|UFH Late group|"Either curative dose, intravenous unfractionated heparin (UFH) so as to reach an anti-Xa activity between 0.3 and 0.7 IU/mL, lengthening the activated prothrombin time as determined by each centre according to the treatment area (depending on the coagulometer and reactants).
~Or low-molecular-weight, curative dose, subcutaneous heparin (LMWH) so as to reach an anti-Xa activity corresponding to treatment areas as determined for each type of molecule (about 0.5 to 1 anti-Xa IU for most LMWHs, administered via 2 daily injections, and about 0.5 to 1.5 anti-Xa IU for tinzaparin, 1 injection daily)."
16109692|NCT02091466|Device|pre-warming|warming patients 30 minutes prior to anesthesia
16109693|NCT02091453|Behavioral|APT training|APT training was used as intensive area-specific cognitive training at four levels: sustained, selective, divided and alternating attention. The APT also includes education in acquired attention deficits and training for generalization. Each session took 45-90 minutes to perform. The APT-test was used to determine the level of difficulty for the attention training.
16109694|NCT02091453|Behavioral|Multiprofessional rehabilitation|Attention training in activities included standard occupational training within an interdisciplinary rehabilitation programme. The programme consisted of training and the use of compensatory strategies in attention-demanding activities of daily living, performing independent work with attention-demanding tasks at individual level and group activities
16109695|NCT02091440|Device|Implant of the HW005 Ventricular Assist System.|The HW005 Pump is in implantable centrifugal pump that was designed to provide flows up to 10 L/min. It is a small device which is both lightweight and simple to use.
16109696|NCT02091414|Drug|mycophenolate mofetil (MMF)|1.0 g PO BID
16109697|NCT02091414|Drug|cyclosporine A (CsA)|Initial loading dose of 4 to 6 mg/kg within 48 hours of transplantation, adjusted thereafter to a blood trough concentration of 150 to 300 ng/mL
16109698|NCT02091414|Drug|corticosteroids|As per the practice of each participating center
16109699|NCT02091401|Device|Springfusor infusion pump|
16109700|NCT02091401|Other|IV administration|
16109701|NCT02091401|Drug|Magnesium Sulfate|
16109702|NCT02091388|Drug|LY03004|
16109703|NCT02091388|Drug|Risperdal® Consta®|
16109704|NCT02091375|Drug|GWP42003-P 20 mg/kg/day Dose|GWP42003-P was an oral solution containing 100 mg/milliliter (mL) cannabidiol (CBD) dissolved in the excipients, sesame oil and anhydrous ethanol (79 mg/mL), with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL).
16109705|NCT02091375|Drug|Placebo control|Placebo oral solution contained the excipients, sesame oil and anhydrous ethanol (79 mg/mL), with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL).
16109706|NCT02091362|Drug|LY2409021|Administered orally
16109707|NCT02091362|Drug|Placebo|Administered orally
16109708|NCT02091362|Drug|Metformin|Administered as background therapy.
16109709|NCT02091349|Other|polydextrose|polydextrose- 7, 14, or 21 grams/day 3X3 latin square with 3 periods
16109710|NCT02091349|Other|soluble corn fiber|nutirose- 7, 14, or 21 grams/day
16109711|NCT02091336|Drug|Metformin|patients treatment
16109712|NCT02091336|Drug|Glyburide|patients treatment
16109713|NCT02091323|Procedure|gastric bypass surgery|With the patient under intubation and general anesthesia, a pneumoperitoneum was created and the pressure was set to 15 mmHg. All LRYGB operations were performed using four trocars. Separate cardiac angle and hepatogastric ligament from the left gastric artery between 2 and 3 branch by hanging liver on the abdominal wall so as to enter into the lesser sac. Reveal the ligament of Treitz, lift the jejunum from the Treitz ligament 75 ~ 150 cm, connect the distal jejunum to the posterior wall of the stomach with a linear cutting staple by an end-to-side anastomosis and suture the common opening at last.
16109714|NCT02091310|Drug|Placebo|
16109715|NCT02091310|Drug|GFT505|
16109716|NCT02091310|Drug|Moxifloxacin 400 mg|
16109717|NCT02091297|Drug|TAP Block|This intervention of a TAP block will be compared to the intervention of Common Care and to the intervention of Patient Controlled Epidural Analgesia
16109718|NCT02091297|Drug|Ropivacaine|The intervention of the Patient Controlled Epidural Analgesia will be compared to the intervention of a TAP block and the intervention of Common Care
16109719|NCT02091297|Drug|Acetaminophen|"Common ways to treat pain control after Cesarean Section include oral and IV opioids, non-narcotic adjuncts such as non-steroidal anti-inflammatory drugs and acetaminophen, and long-acting spinal or epidural opioids such as morphine. Due to the potential issues such as ineffectiveness and fear of respiratory depression, increasing the dosing of these opioids may not be ideal.
~The intervention of Common Care will be compared to the intervention of a TAP block and the intervention of Patient Controlled Epidural Analgesia"
16109720|NCT02091297|Drug|Morphine|
16109721|NCT02091284|Device|transcranial Direct Current Stimulation|Direct currents were transferred via a pair of carbonated-silicone electrodes (35 cm2) with a thick layer of high conductive gel for EEG underneath them. The electric current will be delivered by an electric stimulator. To stimulate the left DLPFC, the cathode electrode was placed over F3 according to the 10-20 international system while the anode was placed over the contralateral F4 region. The currents flowed continuously for 20 minutes with an intensity of 2 milliamperes.
16109722|NCT02091245|Drug|KPT-330|
16109723|NCT02091232|Biological|T Regulatory Cell Infusion|After blood is collected from the donor and recipient, the facility will sort out one particular kind of immune cell called a regulatory T cell which is strongly influenced by tolerance induction to minimize (suppress) responses to the donor cells. In this study, these regulatory T cells are the cells which will be given back to the recipient on Day 7 (+3 days) post-transplant.
16109724|NCT02091219|Drug|Vitamin D|2400 IU/day by mouth for 16 weeks
16109725|NCT02091219|Drug|25(OH)D3|20 micrograms/day by mouth for 16 weeks
16109726|NCT02091206|Drug|GWP42003-P 5 mg/kg/day Dose|GWP42003-P was an oral solution containing 25 mg/milliliter (mL) cannabidiol (CBD) or 100 mg/mL CBD dissolved in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL). Participants were randomly assigned to receive either 5, 10 or 20 mg/kg/day.
16109727|NCT02091206|Drug|Placebo control|Placebo oral solution contained the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL).
16109728|NCT02091206|Drug|GWP42003-P 10 mg/kg/day Dose|GWP42003-P was an oral solution containing 25 mg/mL CBD or 100 mg/mL CBD dissolved in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL). Participants were randomly assigned to receive either 5, 10 or 20 mg/kg/day.
16109729|NCT02091206|Drug|GWP42003-P 20 mg/kg/day Dose|GWP42003-P was an oral solution containing 25 mg/mL CBD or 100 mg/mL CBD dissolved in the excipients sesame oil and anhydrous ethanol (79 mg/mL) with added sweetener (0.5 mg/mL sucralose) and strawberry flavoring (0.2 mg/mL). Participants were randomly assigned to receive either 5, 10 or 20 mg/kg/day.
16109730|NCT02091193|Dietary Supplement|Krill Oil (Supplement A)|
16109731|NCT02091193|Dietary Supplement|Placebo (Supplement B)|
16109732|NCT02091180|Drug|Mannitol|0.5g/kg of 20% intravenous (i.v.) mannitol infusion over 10 minutes immediately before induction of anesthesia
16109733|NCT02091180|Drug|Control|Saline infusion
16109734|NCT02091167|Device|transcranial Direct Current Stimulation|Direct currents are transferred via a pair of carbonated-silicone electrodes (35 cm2) with a thick layer of high conductive gel for EEG underneath them. The electric current is delivered by an electric stimulator. To stimulate the left DLPFC, the cathode electrode is placed over F3 according to the 10-20 international system while the anode is placed over the contralateral F4 region. The currents flows continuously for 20 minutes with an intensity of 2 milliamperes.
16109735|NCT02091154|Behavioral|USDA Regulations|"Implement new USDA regulations assigned school cafeterias.
~Fruit or vegetable on every tray
~Meet requirements for vegetable varieties
~50% of all grains must be whole grain
~Milk must be 1% or skim; flavored milk must be skim"
16109736|NCT02091154|Behavioral|Marketing Kit|"This marketing tool kit is designed to encourage purchasing of school lunches. The marketing tool kit included the following components:
~56''x72'' vinyl sign with the words [school mascot] Cafe
~8.5''x11'' signs describing the foods offered on a specific day
~2''x4'' signs used to name all foods. These were to be placed in a visible location near the corresponding food.
~Magnetic board displaying a tray onto which magnets shaped as food can be placed to show what foods were being offered during a specific lunch shift."
16109737|NCT02091154|Behavioral|Smarter Lunchrooms Makeover (SLM)|"Implement three basic Smarter Lunchrooms techniques. It consists of the following components:
~Place fruit in an attractive bowl or serving dish and set on two places on the line. One of the places should be at or near the register.
~Give all vegetables descriptive names and write or type them on a 2''x4'' card. These cards should be visible and placed near the corresponding food.
~Make white milk the most prominent milk in the milk coolers by making it the most available milk and easiest to take."
16109738|NCT02091141|Drug|Trastuzumab|Trastuzumab will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
16109739|NCT02091141|Drug|Pertuzumab|Pertuzumab will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
16109740|NCT02091141|Drug|Erlotinib|Erlotinib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
16109741|NCT02091141|Drug|Vemurafenib|Vemurafenib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
16109743|NCT02091141|Drug|Vismodegib|Vismodegib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
16109744|NCT02091141|Drug|Alectinib|Alectinib will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
16109745|NCT02091141|Drug|Atezolizumab|Atezolizumab will be administered as per the schedule specified in the respective arm, until tumor progression or occurrence of unacceptable toxicity.
16109746|NCT02091115|Dietary Supplement|dairy drink with probiotic culture|The participants were instructed to consume the dairy drink with probiotic culture containing animalis bifidobacterium with 3.2 x 107 UFC for 60 days and a glass of 150 ml daily.
16109747|NCT02091115|Dietary Supplement|Dairy drink|
16109748|NCT02091102|Device|755nm Alexandrite Laser|755nm Alexandrite Laser for the treatment of Wrinkles
16109749|NCT02091089|Device|755nm Alexandrite laser|755nm Alexandrite laser for the treatment of wrinkles
16109750|NCT02091076|Device|Silk fibroin with bioactive coating layer dressing|
16109751|NCT02091076|Device|Bactigras wound dressing|
16109752|NCT02091063|Drug|ACY-1215|All patients will take the oral ACY-1215 160mg for 28 consecutive days on a 28-day treatment cycle. Each dose will be administered at least 1 hour after ingestion of food and followed by at least 4 ounces of water. Patients will be instructed not to ingest food or other oral medication for at least 2 hours after each ACY-1215 dose.
16109753|NCT02091050|Other|2D HDR planning|HDR planning using simple radiograph (2D)
16109754|NCT02091050|Other|3D HDR planning|HDR planning using computed tomography (3D)
16109755|NCT02091024|Dietary Supplement|ECE (Ecklonia cava extract)|ECE 200mg, twice a day
16109756|NCT02091024|Dietary Supplement|Placebo|Placebo 200mg, twice a day
16109757|NCT02090998|Procedure|SPG Block with 5% Lidocaine gel|cotten tipped applicators are with 5% lidocaine gel and placed in the nares to lye in the skin over the sphenopalitine ganglion. The applcator is use to saturate the spenopalitine ganglion with 5ml of 1% lidocaine local anesthesia
16109758|NCT02090998|Drug|Amitriptyline|The intervention will be Amitriptyline daily (starting with 10 mg) PO for 30 Days
16109759|NCT02090985|Procedure|Lipomodelling of symptomatic peri-stomal skin contour abnormalities|
16109760|NCT02090959|Drug|Ataluren|Ataluren will be administered per the dose and schedule specified in the arm.
16109761|NCT02090933|Drug|Celecoxib|Given PO
16109762|NCT02090933|Other|Laboratory Biomarker Analysis|Correlative studies
16109763|NCT02090933|Procedure|UV Light Therapy|Undergo UV-irradiation
16109764|NCT02090920|Drug|Nifedipine|Nifedipine 10 mg immediate release tablet by mouth loading dose Nifedipine administered orally every 15-20 minutes for the first hour to a maximum loading dose of 30 mg, followed by a maintenance dose of 10-20 mg immediate release nifedipine administered orally every 6 hours
16109765|NCT02090907|Drug|Levothyroxine|
16109766|NCT02090907|Drug|Placebo|
16109767|NCT02090894|Device|UV Light (Laser Genesis)|
16109768|NCT02090881|Other|Ultrasound scan|Trans cranial Doppler ultrasound examination of cerebral arterial blood flow
16109769|NCT02090868|Other|Oral Intake Screening Tool|A screening tool developed from a literature review and expert opinion. It will be used by nurses to assess patients receiving non-invasive ventilation ability to eat and drink orally and suggest what actions should be taken if they are unable to do so
16109770|NCT02090842|Dietary Supplement|Ca-caseinate|
16109771|NCT02090842|Dietary Supplement|Maltodextrin|
16109772|NCT02090842|Dietary Supplement|Whey protein isolate|
16109773|NCT02090829|Drug|Syntocinon (synthetic oxytocin)|Syntocinon is a nine residue cyclic peptide; the hormone is prepared synthetically to avoid possible contamination with vasopressin and other small polypeptides with biologic activity.
16109774|NCT02090829|Other|Placebo|"Placebo Comparator: Intranasal Placebo Intranasal placebo The placebo is identical to the oxytocin formulation with the exception of the active compound.
~Route of administration: Intranasal Planned exposure: Each participant will receive one dose of intranasal placebo per day for 5 days.
~One dose equals 6 spray puffs (3 puffs in each nostril)."
16109775|NCT02090816|Procedure|Surgery of liver and lung|Simultaneous resection of liver and right lung metastases in a single surgical session through a new approach
16109776|NCT02090790|Drug|iv dexamethasone|2 ml 8 mg iv dexamethasone
16109777|NCT02090790|Drug|femoral dexamethasone|2ml 8mg dexamethasone administration added 30 ml 0,5 % bupivacain
16109778|NCT02090790|Drug|serum physiologic|2 ml iv serum physiologic
16109779|NCT02090777|Behavioral|Health Coach|
16109780|NCT02090764|Drug|Ozenoxacin|
16109781|NCT02090764|Drug|Placebo|
16109782|NCT02090738|Drug|Acetazolamide group|
16109783|NCT02090738|Drug|Standard regimen group|
16109784|NCT02090725|Drug|3-4 Diaminopyridine|
16109785|NCT02090712|Procedure|PCI|Balloon dilatation of the culprit artery followed by stent implantation will be made immediately for patients not receiving thrombolysis or after 3 to 24 hours after thrombolysis, under clinical indication and current practice patterns, in the setting of acute myocardial infarction
16109786|NCT02090686|Device|Pulsatile Cupping|"8 cupping sessions (each 8 minutes) in 4 weeks (-150 to -350 mbar), interval 2 seconds.
~Paracetamol on demand as rescue medication (maximum dosage 4 x500 mg/day)"
16109787|NCT02090686|Device|Minimal Cupping|8 cupping sessions (each 8 minutes) in 4 weeks witth (-60 to -70 mbar). Paracetamol on demand as rescue medication (maximum dosage 4 x500 mg/day).
16109788|NCT02090673|Drug|Exenatide|
16109789|NCT02090660|Other|ICG Localization with Spy thoracoscope localization|
16109790|NCT02090647|Behavioral|aesthetic outcome|
16109791|NCT02090634|Behavioral|Psychoeducation|Participants will also receive daily text messages to evaluate mood, but these messages will not remind participants about medication adherence.
16109792|NCT02090634|Behavioral|individualized Texting for Adherence Building (iTAB)|Intervention is designed to send automated text messages to HIV+ persons who have bipolar disorder (BD+). Text messages are personalized, automated, real-time text messages. The iTAB intervention is designed to improve adherence to ART and psychotropic medications among HIV+/BD+ persons above and beyond an active comparator group.
16109913|NCT02089568|Drug|Normal Saline|Placebo - 0.9% saline
16110385|NCT02086006|Device|DESolve Novolimus Eluting Bioresorbable Coronary Scaffold|
16109793|NCT02090621|Procedure|Extracorporeal photopheresis|Extracorporeal photopheresis with Methoxsalen(UVADEX)and immunosuppression reduction Extracorporeal photopheresis (ECP) is an immunomodulatory excellent technical tolerated initially designed for the treatment of cutaneous T-cell lymphoma and various autoimmune diseases, which has been proven effective in reversing episodes acute heart transplants, kidney and lung rejection, and in the treatment of Disease graft versus host both acute and chronic.
16109794|NCT02090608|Drug|Paricalcitol|Paricalcitol was administered at the dose of 1 mcg/die
16109795|NCT02090595|Behavioral|MBCT-C|A 12 week group therapy program for children with anxiety disorders. This involves teaching the children the pay attention to anxiety related cues with openness and non-judgment. Group leaders begin each session with: sitting meditation, review of the previous session and home practices, teaching a new mindfulness exercise, reading a group poem or story, distributing handouts, etc. There will be a new theme each week.
16109796|NCT02090595|Behavioral|Waitlist Control|Waitlist Control (WC) will be the comparison condition. Some of the children in the study will initially participate in a 12 week WC prior to their participation in the MBCT-C. At each visit during the waitlist control period, participants and their families will receive materials about mood and anxiety disorders in youth, bipolar disorders, familial risk for bipolar disorder and treatment strategies for anxiety and depression in youth.
16109797|NCT02090582|Other|Structured Palliative Care|Structured palliative care approach, defined as the gynecologic oncology team performing comprehensive symptom assessment with the Quality Data Collection Tool Palliative Care (QDACT-PC) and providing interventions based on National Comprehensive Cancer Network (NCCN) guidelines. Symptom scores above the acceptable threshold in the QDACT-PC tool that occur after two consecutive visits will automatically trigger palliative care consultation.
16109798|NCT02090582|Other|Usual Care|Usual care described as current practice by the gynecologic oncology team with referral to PC specialist at provider discretion or at the request of the patient or their families.
16109799|NCT02090569|Device|Functional micro-Doppler Sonography (fmDS)|"Craniotomy according to MRI images
~Dura opening
~Sulcal Localization using neuronavigation
~Functional micro-Doppler Sonography including morphologic (Bmode) and functional measurement of the cerebral blood volume dynamics at high spatio-temporal resolution (100µm-20ms) using high-frequency (15MHz) ultrasound. At least 5 2-minute periods of spontaneous data will be recorded with a sampling rate for data acquisition of 15KHz and highpass filter of 10 to 70 Hz.
~Exeresis of the dysplasic tissue
~Control using fmDS before wound closure"
16109800|NCT02090556|Drug|Abatacept|
16109801|NCT02090543|Drug|Phenprocoumon (Marcumar)|common use, no requirements (real life situation)
16109802|NCT02090543|Drug|Rivaroxaban (Xarelto, BAY-59 7939)|common use, no requirements (real life situation)
16109803|NCT02090530|Other|Biospecimen collection|Specimens to be collected include a fresh tumor biopsy, previously obtained tumor specimens or blocks (if available), whole blood, serum, plasma and buccal smear.
16109804|NCT02090517|Device|Pulsed Dye Laser|Pulsed dye laser treatments will be performed with a 595 nanometer wavelength, 20 millisecond pulse duration, at 10 Joules/cm2, with a 10 millimeter spot size.
16109805|NCT02090517|Device|Long Pulsed Alexandrite Laser|Alexandrite laser will be used with a 755 nanometer wavelength, 40 millisecond pulse duration, at 88Joules/cm2, with a 6 millimeter spot size.
16109806|NCT02090517|Device|Pulsed Dye Laser Plus Nd:YAG Laser|The Cynergy with MultiPlex will be used with a multiplex mode system with a pulse dye laser at 585 nanometer wavelength, 20 milliseconds pulse duration, at 7 Joules/cm2 with a 7 millimeter spot size, with a short delay, followed by a Nd:YAG 1064 nanometer wavelength, 20 millisecond pulse duration, at 50 Joules/cm2 with a 7 millimeter spot size.
16109807|NCT02090517|Procedure|Electrodesiccation|A curette is used to scrape off the cancer down to the dermis. The scraping is then paused while an electrosurgical device like a hyfrecator is used next. Electrodesiccation is performed over the raw surgical ulcer to denature a layer of the dermis and the curette is used again over the surgical ulcer to remove denatured dermis down to living tissue.
16109808|NCT02090504|Drug|Sodium Oxybate (SMO)|
16109809|NCT02090504|Drug|Oxazepam|
16109810|NCT02090478|Other|Low sugar diet|All subjects followed their usual diet during month 1. For months 2-4: sham diet intervention for the control group, 40% reduction in sugar calories for the experimental group. All subjects were allowed to chose any diet they wished during month 5.
16109811|NCT02090478|Other|Sham diet manipulation|Subjects in the control group will meet with a dietician and discuss diet records, but the dietician will not instruct the control subjects to reduce the number of calories from simple sugars in the diet
16109812|NCT02090465|Drug|Ingenol Mebutate|No intervention: observation of routine use of Picato®
16109813|NCT02090452|Device|Real time transmission of patient related data. Device used: MobiMed 3.1, manufactured by Ortivus AB Sweden|
16109814|NCT02090439|Drug|Silodosin|
16109815|NCT02090426|Other|Link2Care|
16109816|NCT02090413|Drug|dimethyl fumarate|
16109817|NCT02090413|Drug|acetylsalicylic acid|enteric-coated capsule
16109818|NCT02090413|Drug|ASA-Placebo|matched placebo
16109819|NCT02090400|Drug|Bazedoxifene|20 mg Oral daily for 12 months
16109820|NCT02090400|Drug|Calcium/Vit D|Calcium 500 mg / 400 IU Vit D
16109821|NCT02090387|Other|ONS without AN777|2 servings a day
16109822|NCT02090387|Other|ONS containing AN777|2 servings a day
16109823|NCT02090374|Other|TLR Agonist|Preceding incremental ascending dose study to be used to assess top safe dose.
16109824|NCT02090374|Other|Tuberculin nasal challenge|Preceding incremental ascending dose study to be used to assess safe top dose.
16109825|NCT02090374|Other|Timothy Grass Pollen|Dose: 5000 SQ-U/100µl
16109826|NCT02090361|Procedure|skin graft|Epidermization of the defect by applying a thin layer of autologous epidermis
16109827|NCT02090348|Drug|dimethyl fumarate|Administered as specified in the treatment arm
16109828|NCT02090335|Behavioral|In SHAPE|In SHAPE is a health promotion intervention consisting of a fitness club membership and a health promotion coach with basic certification as a fitness trainer, instruction on principles of healthy eating and nutrition, and training in tailoring individual wellness plans to the needs of persons with serious mental illness.
16109829|NCT02090335|Behavioral|Fitness Club Membership|Fitness club membership with education in using the exercise equipment.
16110001|NCT02088918|Drug|Nateglinide|
16109830|NCT02090322|Procedure|Injection of bevacizumab intravitreal (Avastin)|"The treatment of Retinopathy of prematurity is with bevacizumab intravitreal for resolution of the illness.
~When there is a Retinopathy of prematurity type 1, is the indication for the infection"
16109831|NCT02090309|Drug|Hydrocortisone|100 mg IV (in the vein) injection as a single bolus of hydrocortisone for the study group.
16109832|NCT02090309|Drug|normal saline 0.9%|IV injection of 5 ml normal saline 0.9% as a single bolus.
16109833|NCT02090296|Drug|Hydroxyurea|
16109834|NCT02090296|Other|Placebo|
16109835|NCT02090283|Drug|SD-101 dermal cream (6%)|SD-101 is a white, crystalline powder that is formulated within an odorless, soft, white cream base. SD-101-6.0 cream contains allantoin, a diureide glyoxylic acid, at a concentration of 6% and other excipients.
16109836|NCT02090257|Behavioral|TRANSIT|Educational Modules, staff follow up.
16109837|NCT02090244|Drug|Teriparatide|Daily injections with teriparatide 20 µg (PTH 1-34 (Forteo®)) during four weeks
16109838|NCT02090231|Device|rTMS, Magstim Rapid2|5 Hz rTMS
16109839|NCT02090218|Device|I-Gel|I-Gel supraglottic airway device
16109840|NCT02090218|Device|LTS, ETI or current airway management practice|Laryngeal tube, endotracheal tube, bag-mask-ventilation
16109841|NCT02090205|Procedure|Non-ventilation during CPB|Patients that will not be ventilated during cardio-pulmonary bypass
16109842|NCT02090205|Procedure|Ventilation with CPAP|These patients will receive CPAP (at least 5 cmH2O and FiO2 50%-80%)
16109843|NCT02090205|Procedure|Ventilation with 5 act/minute|These patients will receive mechanical ventilation (5 acts/minute) during CPB
16109844|NCT02090205|Device|CPAP|Continuous Positive Air Pressure, applicated during cardio-pulmonary bypass
16109845|NCT02090205|Device|Ventilator: 5 act/minute|Tidal volume = 2-3 ml/kg + PEEP = 3-5 cmH2O.
16109846|NCT02090192|Procedure|WBV training|
16109847|NCT02090192|Procedure|PRT training|
16109848|NCT02090166|Other|Blood test|a blood test will be taken from each patient
16109849|NCT02090153|Drug|S-1|40~60mg bid，d1~7 q2W
16109850|NCT02090153|Drug|LV|LV is given simultaneously at a ﬁxed dose of 25 mg b.i.d. on days 1-7, followed by a 7 day rest.
16109851|NCT02090140|Procedure|ADSC Application|Patients will undergo arthroscopic resection of approximately 5cc of the infrapatellar fat pad, which will be collected for processing for a population of ADSCs. Patients will undergo arthroscopy and preparation of the chondral defect and removal of the calcified cartilage layer. Tisseel Fibrin glue will be placed at the base of the defect side, followed by the application of the acellular collagen dermal matrix, ADSCs, and an additional layer of fibrin glue.
16109852|NCT02090140|Procedure|Microfracture|Microfracture surgery is the standard of care for articular cartilage lesions. Patients will undergo arthroscopy with standard technique of microfracture preparation, including the creation of vertical, stable defect edges and removal of the calcified cartilage layer. A microfracture awl will then be used to perform the microfracture technique (6mm below the subchondral plate).
16109853|NCT02090127|Drug|ficlatuzumab|humanized anti-hepatocyte growth factor (HGF) monoclonal antibody IV administration at 16.5mg/kg every 2 weeks with a ±2 day window around dosing dates, as long as subject is deriving clinical benefit as determined by the Investigator
16109854|NCT02090114|Drug|Testosterone cypionate|DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
16109855|NCT02090114|Drug|Testosterone Enanthate|Testosterone Enanthate Injection, for intramuscular injection, contains testosterone enanthate which is the oil-soluble ester of the androgenic hormone testosterone. Enanthate Injection is available as a colorless to pale yellow solution. Each mL contains 200 mg testosterone enanthate in sesame oil with 5 mg chlorobutanol as a preservative.
16109856|NCT02090114|Drug|Abiraterone acetate (Cohort B = CLOSED TO ACCRUAL)|Abiraterone is an inhibitor of CYP17 (17α-hydroxylase/C17,20-lyase). Each ZYTIGA tablet contains 250 mg of abiraterone acetate.
16109857|NCT02090114|Drug|Enzalutamide (Cohort A = CLOSED TO ACCRUAL)|XTANDI is provided as liquid-filled soft gelatin capsules for oral administration. Each capsule contains 40 mg of enzalutamide as a solution in caprylocaproyl polyoxylglycerides.
16109858|NCT02090101|Drug|ANAKINRA|
16109859|NCT02090088|Drug|Not applicable- observational study|
16109860|NCT02090075|Drug|apixaban|5 po or 2.5 po bid.
16109861|NCT02090075|Drug|warfarin|
16109862|NCT02090049|Dietary Supplement|Puravita Breakfast|The study was done in duplicate i.e two different days each meal (control and experimental) separated at least one week in time. Subjects were instructed to consume the test meal within 10 min from commencement. They subsequently completed VAS on appetite sensation every 30 min until a total of 4 hours. At the end of the test day, an ad libitum lunch consisting of a standardized pizza (17E% protein, 34E% fat and 49E% carbohydrate) and water (300 ml) was served. The subjects were instructed to eat until comfortably satisfied. Food intake was registered and energy intake (EI) calculated afterwards.
16109863|NCT02090049|Dietary Supplement|Control|The control breakfast consisted of white bread (85 g), jam (10 g) and margarine (2 g) to adjust for energy density, fat and sugar levels.
16109864|NCT02090036|Drug|Primaquine (For artemether-lumefantrine+primaquine arm)|A 0.25 mg/kg single-dose primaquine will be administered concomitantly with the first dose of artemether-lumefantrine in all patients randomized into the artemether-lumefantrine+primaquine arm.
16109865|NCT02090036|Drug|Placebo (For artemether-lumefantrine arm)|Volume of normal saline mixed with coloured fruit juice measured based on weight bands will be given orally concomitantly with first dose of artemether-lumefantrine.
16109866|NCT02090010|Procedure|Seldinger technique|"The aimed vessel(subclavian vein) is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and the needle is removed.
~After that catheter is passed over the guidewire into the vessel."
16109867|NCT02090010|Procedure|Modified Seldinger technique|The aimed vessel is punctured with the needle that is covered with guiding sheath. After vessel is punctured, guiding sheath is instantly slid over the needle into the vessel. The needle is removed, guidewire is advanced through the sheath, central catheter is placed into the vessel.
16109868|NCT02089997|Drug|Sodium Risedronate|Sodium risedronate tablets
16109869|NCT02089984|Behavioral|Internet Based CBT Training|
16109871|NCT02089932|Drug|peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block|"ultrasound guided femoral nerve block with injection of 25 ml bupivacaine 0.5% perineurally with 1 ml dexmedetomidine 25, 50, or 75 microgram perineurally.
~After adequate assessment of femoral nerve block, patients will be transferred to the operating room to receive a standard general anesthesia."
16109872|NCT02089932|Drug|Placebo|
16109873|NCT02089919|Biological|cancer stem cell vaccine|
16109874|NCT02089893|Device|Fundus photography|Non-mydriatic fundus photographs
16109875|NCT02089880|Device|C-brace|The participant will receive 6 sessions of training over a one month period in using the C-brace in all levels of functional gait. The participant will then continue use of the C-brace for one month following training. The C-Brace from Otto Bock is an orthosis that controls throughout stance and swing phases of gait with a micro-processor (MP) controlled knee.
16109876|NCT02089880|Device|Stance control orthosis|The participant will receive 6 sessions of training over a one month period in using his current stance control knee-ankle-foot orthosis (SCO) in all levels of functional gait. The participant will then continue use of the SCO for one month following training. The SCO controls the knee by maintaining it straight and extended during the stance phase of gait.
16109877|NCT02089867|Other|Ezetimibe + plant sterols|The ezetimibe + plant sterols group will receive ezetimibe 10 mg/day + spread enriched with 2g daily of plant sterols for 6 weeks
16109878|NCT02089867|Drug|Ezetimibe|The ezetimibe group will receive 10 mg/day ezetimibe for 6 weeks.
16109879|NCT02089867|Dietary Supplement|Plant sterols|The plant sterol group will receive spread enriched with 2g daily of plant sterols for 6 weeks
16109880|NCT02089854|Drug|Toremifene; Anastrozole|Toremifene 60mg PO. per day for premenopausal and perimenopausal patients; Anastrozole 1mg PO. per day for postmenopausal patients
16109881|NCT02089841|Drug|Artemether-lumefantrine|Blood samples will be collected on blood slides and filter papers for asexual parasites assessment both by microscope and molecular genotyping respectively following treatment with artemether-lumefantrine, to assess its efficacy.
16109882|NCT02089828|Other|autologous purified CD34+ cells|
16109883|NCT02089828|Other|autologous peripheral blood mononuclear cells|
16109884|NCT02089815|Behavioral|Home based exercise|modified Otago exercise program to simple designed home based exercise program
16109885|NCT02089815|Other|fall prevention education and counseling|
16109886|NCT02089802|Drug|Pazopanib|
16109887|NCT02089763|Biological|pegylated recombinant human arginase|
16109888|NCT02089750|Other|Orthotics|
16109889|NCT02089750|Other|Orthotics Plus Chiropractic Care|The six week Chiropractic Care portion of this intervention may include the use of ice packs, hot packs, massage, and chiropractic manipulations to the spine or lower extremities (utilizing High Velocity Low Amplitude and/or Flexion Distraction manipulations).
16109890|NCT02089750|Other|Wait List|
16109891|NCT02089737|Drug|Panitumumab|Panitumumab for intravenous infusion
16109892|NCT02089698|Device|Mini-flared|Mini-flared Kelman tip
16109893|NCT02089698|Device|Reversed tip|Reversed Kelman tip
16109894|NCT02089685|Biological|Pembrolizumab|
16109895|NCT02089685|Biological|PegIFN-2b|
16109896|NCT02089685|Biological|Ipilimumab|
16109897|NCT02089672|Device|Catheter ablation|This is observational trial studying the effects of a standard intervention of a catheter ablation procedure.
16109898|NCT02089659|Drug|Doravirine|Following an overnight fast, a single tablet of 100 mg doravirine was be administered orally
16109899|NCT02089633|Biological|PACOX|Pegylated recombinant human arginase 1 in combination with Oxaliplatin and Capecitabine
16109900|NCT02089620|Drug|Yasmin|will be used every 21 days for three months by the patient
16109901|NCT02089620|Dietary Supplement|Calver|Calver will be given daily for 3 months
16109902|NCT02089620|Drug|Placebo 1|Patients will receive a daily placebo similar in size and structure to calvar.
16109903|NCT02089620|Drug|Placebo 2|Women will receive an oral placebo similar to COC for 21 days starting from the 3rd day of menstruation
16109904|NCT02089607|Device|Thoracoabdominal Aortic Aneurysm Arm|"The Zenith Fenestrated-Branched System is a tubular graft made of polyester fabric sewn to stainless steel stents that keep the graft open. The graft will be inserted through arteries in the leg (called endovascular repair). This procedure uses catheters that go inside the blood vessel to place a stent graft above and below the aneurysm.
~The graft includes 1 to 5 small holes (fenestrations) or cuffs (side branches). The arteries to the liver, intestine, and kidneys will be have a stent (small tubular stainless steel structures) to help keep the arteries open and aligned with the fenestrations or branches."
16109905|NCT02089607|Device|Aortic Arch Aneurysm Arm|The endovascular graft includes the main aortic arch portion and one to three cuffs (side branches) that allow the graft to be located in the aortic arch. The number of cuffs is decided based on the anatomy of your aneurysm. The arteries in the aortic arch are the innominate artery (Zone 0), left common carotid artery (Zone 1) and the left subclavian artery (Zone 2). These arteries supply the right arm and right side of the brain, the left side of the brain and the left arm, respectively. The main aortic endovascular graft will be connected into the innominate artery, left common carotid artery and left subclavian artery using additional stents into the branch vessels.
16109906|NCT02089594|Drug|Hyperbaric Oxygen|HBOT Group: Pressurization will proceed with 100% oxygen at 1.0 pounds per square inch (psi) per minute, the minimal pressurization rate, to 1.5 ATA (atmospheres absolute) or 7.35 psi and will take approximately 7 minutes. Pressurization will then resume until the final depth of 1.5 ATA is achieved. The patient will remain at depth for approximately 45 minutes and the subject will be informed of the onset of depressurization, which will occur at the same rate as pressurization. Total dive time will be 60 minutes.
16109907|NCT02089594|Drug|No Hyperbaric Oxygen|Subjects will receive their usual care during the equivalent eight-week HBOT treatment period. There will be no hyperbaric chamber experience. At the conclusion of the eight-week control period both control and experimental subjects will be retested and the control group will be crossed over to receive the identical 40 HBOTs of the HBOT group.
16109908|NCT02089581|Drug|Active comparator MR2XXX|comparison of two new oral formulations with existing formulation
16109909|NCT02089581|Drug|MRXXX|MRXXX
16109910|NCT02089581|Drug|MR1XXX|
16109911|NCT02089581|Drug|MRXXX and MR1XXX|MRXXX and MR1XXX in fed and fasted state
16109912|NCT02089568|Drug|Co-Amoxiclav|Will receive 1.2g co-amoxiclav at induction
16109914|NCT02089555|Procedure|Lumbar puncture|Cerebrospinal fluid (CSF) will be collected via lumbar puncture. During lumbar puncture, a needle is inserted between two lumbar bones (vertebrae) to remove a sample of cerebrospinal fluid. The procedure involves inserting a thin, hollow needle between the two lower vertebrae (lumbar region), through the spinal membrane (dura) and into the spinal canal and extracting a small amount of fluid. The procedure takes about 45 minutes.
16109915|NCT02089555|Procedure|Blood draw|One tube of blood will be collected in an ethylenediaminetetraacetic acid (EDTA)-K2 plasma tube for DNA analysis.
16109916|NCT02089555|Procedure|Magnetic Resonance Imaging (MRI)|Each participant will undergo Magnetic Resonance Imaging (MRI) analysis using a modified Alzheimer's Disease Neuroimaging Initiative (ADNI) protocol with a 3 Tesla (3T) MRI Scan. The exam takes approximately 20 minutes.
16109917|NCT02089542|Other|MB and fluorescent imaging|Single arm study for the development of a protocol stipulating the optimum dose and time to peak near infra-red fluorescence from intraoperative injection of low dose Methylthioninium chloride
16109918|NCT02089529|Drug|Ibuprofen|Ibuprofen/Ibumetin with no information, positive information and neutral information
16109919|NCT02089529|Drug|Placebo|Placebo with no information, positive information and neutral information
16109920|NCT02089503|Other|intravitreal injections of Lucentis|intravitreal injections FOR ALL PATIENTS of Lucentis as required in the normal condition of use
16109921|NCT02089490|Device|NEVELIA® implantation|Skin substitute implantation followed by ultra-thin epidermal graft
16109922|NCT02089477|Other|Support group|"The participants in the intervention group receives the intervention and support consisting of:
~Individual Goal Setting: 2-3 functional goals related to everyday life evaluated every 4th week.
~SMS send every Sunday with 5 possible responses. depending on the answer of the participant it will cause a telephone call from a project about motivation and barriers for interval walking."
16109923|NCT02089464|Device|NBS-guided rTMS|
16109924|NCT02089464|Device|Sham rTMS|
16109925|NCT02089464|Procedure|Task oriented rehabilitation|
16109926|NCT02089451|Drug|Faster-acting insulin aspart|Drug: insulin aspart (faster acting insulin aspart) Subjects will receive five single dose level of faster acting insulin aspart. Three single dose s.c under the skin (abdomen, deltoid/upper arm, thigh), one single dose i.m. (intramuscularly, into the muscle) and one single dose i.v. (intravenously, into the vein)
16109927|NCT02089438|Drug|Saxagliptin|Saxagliptin (5 mg) is given before breakfast
16109928|NCT02089438|Drug|Vildagliptin|Vildagliptin (50mg) is given before breakfast and dinner
16109929|NCT02089438|Drug|Sitagliptin|Sitagliptin (100 mg) is given before breakfast
16109930|NCT02089425|Drug|K-103-IP|
16109931|NCT02089425|Drug|Placebo|Placebo comparator
16109932|NCT02089412|Drug|E2006|
16109933|NCT02089399|Drug|Sevikar(amlodipne/olmesartan)|Treatment AB
16109934|NCT02089399|Drug|crestor(Rosuvastatin)|Treatment AB/Treatment C
16109935|NCT02089386|Drug|Tamoxifen|
16109936|NCT02089386|Procedure|Endoscopy|
16109937|NCT02089373|Procedure|Probe-based confocal laser endomicroscopy|In this arm1, an investigator observes a cancerous lesion using white light endoscopy. In addition, contrast dye for confocal laser endomicorscopy (fluorescein sodium 0.1mL/kg) is administered. Then, the cancerous lesion is observed using probe-based confocal laser endomicroscopy. The biopsy would be done 5 times at the most suspcious parts of the cancerous lesion.
16109938|NCT02089373|Procedure|White light endoscopy|In this arm2, an invesigator observes a cancerous lesion using white light endoscopy. The biopsy would be done 5 times at the most suspicious parts of the cancerous lesion.
16109939|NCT02089347|Biological|Tdap: Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed|0.5 mL, intramuscularly.
16109940|NCT02089347|Biological|Diphtheria and Tetanus toxoids adsorbed|0.1 mL, Subcutaneously
16109941|NCT02089334|Drug|RX-0201|"RX-0201 will be administered in a dose up to 250mg/m^2/day as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles in Stage 1.
~In Stage 2, RX-0201 will be administered the dose determined in Stage 1 as a continuous infusion for a cycle of 21 days (14 days infused followed by 7 days off) for up to 8 cycles."
16109942|NCT02089308|Drug|Test treatment : V0116 transdermal patch|
16109943|NCT02089308|Drug|Reference treatment : Nicotine transdermal patch|
16109944|NCT02089295|Drug|Oxycodone|One capsule of 5 mg PF-00345439 Formulation K, single dose, under fed conditions
16109945|NCT02089295|Drug|Oxycodone|One capsule of 20 mg PF-00345439 Formulation K, single dose, under fed conditions
16109946|NCT02089295|Drug|Oxycodone|One capsule of 40 mg PF-00345439 Formulation K, single dose, under fed conditions
16109947|NCT02089282|Device|Ultrasound|
16109948|NCT02089256|Drug|Liraglutide|"Graded glucose infusion test (GGIT)will be performed on baseline. 1 week later treatment with liraglutide 0.6mg/day (injected between 21.00-23.00) will be initiated.
~GGIT will be repeated 12 hours after first injection and after 21 days on-treatment (12 hours after last injection)."
16109949|NCT02089243|Procedure|Vagus nerve stimulation therapy|The adjustments in device parameters were performed, individually, and solely at the discretion of the primary epileptologist with a formal protocol guiding changes.
16109950|NCT02089243|Procedure|Resective surgery|The experienced neurosurgery are responsible for the selection of surgical techniques employed for medically refractory medial temporal lobe epilepsy that provide an effective treatment with significant preservation of neurological function and acceptable surgical risks.
16109951|NCT02089230|Drug|MEK 162|"Phase I Starting Dose of MEK 162: 15 mg by mouth twice a day in a 28 day cycle.
~Phase II Starting Dose of MEK 162: Maximum tolerated dose from Phase I."
16109952|NCT02089217|Procedure|Carotid endarterectomy (CEA)|Carotid endarterectomy
16109953|NCT02089217|Device|Carotid Stenting (CAS)|Carotid stenting
16109954|NCT02089217|Other|Intensive Medical Management - no CEA|Intensive Medical Management alone - no CEA
16109955|NCT02089217|Other|Intensive Medical Management - no CAS|Intensive Medical Management alone - no CAS
16109956|NCT02089204|Radiation|FMISO-PET/CT|Fluorine-18-labeled fluoromisonidazole PET/CT-guided dose escalation chemoradiotherapy (group C). Radiotherapy was delivered using the simultaneous modulated accelerated radiation therapy (SMART) technique in the dose-escalation treatment arms. Patients received concurrent and adjuvant chemotherapy.
16110002|NCT02088918|Drug|Nateglinide/Metformin|
16110003|NCT02088918|Drug|Metformin|
16109957|NCT02089204|Radiation|FDG-PET/CT|18F-FDG PET/CT -guided dose escalation chemoradiotherapy. Radiotherapy was delivered using the simultaneous modulated accelerated radiation therapy (SMART) technique in the dose-escalation treatment arms. Patients received concurrent and adjuvant chemotherapy.
16109958|NCT02089204|Radiation|contrast-enhanced CT|contrast-enhanced CT -guided dose escalation chemoradiotherapy. Radiotherapy was delivered using the simultaneous modulated accelerated radiation therapy (SMART) technique in the dose-escalation treatment arms. Patients received concurrent and adjuvant chemotherapy
16109959|NCT02089191|Device|Nelfilcon A contact lenses|
16109960|NCT02089191|Device|Stenfilcon A contact lenses|
16109961|NCT02089178|Procedure|intravenous anesthesia|total intravenous anesthesia group: propofol-remifentanil
16109962|NCT02089178|Procedure|inhalation anesthesia|inhalation anesthesia group: sevoflurane-remifentanil
16109963|NCT02089178|Drug|propofol-remifentanil|
16109964|NCT02089178|Drug|sevoflurane-remifentanil|
16109965|NCT02089165|Dietary Supplement|Krill oil|Krill oil from Antarctic krill, per oral, capsule, targeted daily n-3 PUFA dose of 1 700 mg, single administration
16109966|NCT02089165|Dietary Supplement|Krill meal|Krill meal, granular meal from Antarctic krill, per oral, targeted daily n-3 PUFA dose of 1 700 mg, single administration
16109967|NCT02089165|Dietary Supplement|Fish oil|Fish oil, per oral, capsule, targeted daily n-3 PUFA dose of 1 700 mg, single administration
16109968|NCT02089152|Other|An educational programme for prevention of melioidosis|The intervention will be randomly implemented at 10, 10 and 10 diabetic clinics at the end of years 1, 2 and 3, respectively. The education will be conducted using small group education, in which 20 to 25 participants at a time will attend group sessions conducted by the study team.
16109969|NCT02089139|Device|Discogel|DiscoGel is a sterile viscous solution containing ethyl alcohol, cellulose derivative product and tungsten (radio-opaque element)
16109970|NCT02089139|Other|conventional treatment|"Conventional treatment based on current guidelines regarding the management of discogenic low back pain, including but not limited to:
~medications (analgesics, NSAIDs, muscle relaxants),
~physical therapy,
~manual techniques,
~transcutaneous electrical nerve stimulation (TENS),
~blocks"
16109971|NCT02089126|Drug|Gemigliptin/Glimepiride combination|
16109972|NCT02089113|Drug|Dexamethasone|
16109973|NCT02089113|Procedure|Placebo Vehicle|
16109974|NCT02089100|Radiation|stereotactic body radiation therapy|
16109975|NCT02089100|Radiation|Systemic treatment|
16109976|NCT02089087|Biological|CFZ533|Single dose at varying dosage levels depending on treatment assignment
16109977|NCT02089087|Drug|Placebo|
16109978|NCT02089074|Behavioral|Drug use counselling|
16109979|NCT02089061|Drug|BMS-919373|
16109980|NCT02089061|Drug|Rosuvastatin|
16109981|NCT02089061|Drug|Atorvastatin|
16109982|NCT02089048|Drug|Auranofin|Auranofin is a gold-containing chemical salt available as 3mg capsules. Cohort 1 receives 6mg oral dose of auranofin once every 24 hours for 7 days
16109983|NCT02089035|Dietary Supplement|MUFA-rich dairy products (UHT milk, cheese and butter)|
16109984|NCT02089035|Dietary Supplement|Conventional dairy products (UHT milk, cheese, butter)|
16109985|NCT02089022|Other|Physiotherapy resources|The application of ice has been accomplished by means of a plastic bag containing 1.5 kg of crushed ice. The duration of the application was 30 minutes. The use of shortwave diathermy was performed by means of rectangular electrodes having a duration of 20 minutes.
16109986|NCT02089009|Other|Retinal imaging|Retinal imaging by using non-mydriatic camera devices
16109987|NCT02089009|Other|Vessel measurements|Vessel measurements based on the taken images by the use of a specialized software
16109988|NCT02089009|Other|Change in vessel diameters|Change of vessel diameters before and after delivery based on the taken images by the use of a specialized software
16109989|NCT02088996|Device|longwave diathermy on high power and interferential therapy|
16109990|NCT02088996|Device|longwave diathermy on low power|
16109991|NCT02088983|Dietary Supplement|CDP-Choline|Capsule
16109992|NCT02088983|Dietary Supplement|Cellulose|Capsule
16109993|NCT02088970|Device|Crosslinking|"The procedure of the cross linking is standard:combined riboflavin(Ricrolin®)-ultraviolet type A rays (UVA) collagen cross-linking. Radiant energy was 3 milliwatts/cm2 or 5.4 joule/cm2 for a 30-minute exposure irradiation of the cornea.
~Patients are checked every days during the hospitalisation and one week, one month and 3 months after the hospitalisation."
16109994|NCT02088970|Drug|antibiotic treatment|"If not the contact lens wearer -> Cocci Gram positive cocci
~Vancomycin + Fortum
~If contact lens wearer -> Gram negative bacillus
~Fortum + Amiklin
~If corticosteroids, immunosuppression, latent evolution -> Fungus.
~= Fortum + vancomycin + Fungizone"
16109995|NCT02088957|Drug|Brivaracetam intravenous solution|"Active Substance: Brivaracetam
~Pharmaceutical Form: Solution for infusion
~Concentration: 10 mg/mL
~Route of Administration: Intravenous bolus use"
16109996|NCT02088957|Drug|Brivaracetam oral tablets|"Active Substance: Brivaracetam
~Pharmaceutical Form: Film-coated tablet
~Concentration: 10 mg and 25 mg tablets; Daily Dose: 200 mg/day (100 mg bid)
~Route of Administration: Oral use"
16109997|NCT02088957|Drug|Phenytoin intravenous solution|"Active Substance: Phenytoin
~Pharmaceutical Form: Solution for infusion
~Concentration: 50 mg/mL
~Route of Administration: Intravenous use"
16109998|NCT02088957|Drug|Phenytoin oral tablets|"Active Substance: Phenytoin
~Pharmaceutical Form: Tablet
~Concentration: Weight based
~Route of Administration: Oral use"
16109999|NCT02088944|Drug|Infliximab|
16110000|NCT02088931|Biological|Treg infusion|At the time of Treg infusion (day 0), maintenance immunosuppression will remain unchanged which consists of TAC, MPA and steroids. On follow-up biopsy 2 weeks after Treg infusion, the inflammatory load will be assessed by computer assisted image analysis looking at the number of infiltrating cells per square mm as well as the percentage of renal cortex infiltrated with lymphocytes. If the inflammatory load has decreased by ≥50% and infused Tregs are observed in the allograft, everolimus will be started at 1.5 mg bid and the dose of tacrolimus will be decreased by 50%. After 2 weeks, tacrolimus will be discontinued. These patients will remain on everolimus, mycophenolic acid and prednisone through the end of the study and the follow-up period. If on the 2-week follow-up biopsy, there is no decrease in the inflammatory load or there is a decrease <50%, no change will be made to the maintenance immunosuppressive regimen consisting of TAC, MPA and prednisone.
16110004|NCT02088905|Behavioral|Parent Child Interaction Therapy|Parent-Child Interaction Therapy (PCIT) is a research-supported parent coaching intervention that has been found to be highly effective among typically developing preschoolers presenting with a range of mental health concerns, especially defiance and noncompliance.6 PCIT holds considerable promise as a potentially effective treatment for children with ASD because it directly addresses the behaviors parents of children with ASD report to be most problematic for them - defiance, stubbornness, and temper tantrums. PCIT is theoretically consistent with other approaches that have shown promise in treating ASD (i.e., behaviorally-based); however, PCIT is unique in that it incorporates a socially-based initial phase which may have some unique benefits for children with ASD.
16110005|NCT02088892|Drug|BCG SSI|Intradermal injection
16110006|NCT02088892|Drug|BCG Tice|Intradermal injection
16110007|NCT02088879|Behavioral|chest compression with kneeling position|
16110008|NCT02088879|Behavioral|chest compression with standing position|
16110009|NCT02088866|Drug|Transdermal Lidocaine|The intervention will use 5% commercially available transdermal lidocaine in clinical practice for the treatment of tinnitus. This dose will be tailored to patient preference.
16110012|NCT02088827|Other|Inactivity|Subjects will remain inactive (lying on a bed) for 4 hours.
16110013|NCT02088827|Other|Activity|Subjects will spend 4 hours of inactivity (lying on a bed) broken up by 2 minutes of moderate intensity biking (on a stationary bike) every 20 minutes.
16110014|NCT02088814|Behavioral|'EPICAP'|standardized, secondary preventive psychological intervention with parents of children ages 1-4 with acute burn injuries, consisting of psychoeducation, trauma narrative, storybook, provision of coping skills
16110015|NCT02088801|Device|Airtraq, blade without channel for tracheal tube intubation|Intubation
16110016|NCT02088801|Device|KingVision , blade without channel for tracheal tube intubation|
16110017|NCT02088801|Device|A.P. Advance, blade without channel for tracheal tube intubation|
16110018|NCT02088801|Device|Macintosh|
16110019|NCT02088788|Device|Board|Also has radio-dense pelvic shielding
16110020|NCT02088788|Device|No Board|Radio-lucent armboard for radial access with radio-dense drape across pelvis
16110021|NCT02088775|Procedure|PET scan|Undergo PET-CT scan
16110022|NCT02088775|Procedure|CT Scan|Undergo PET-CT scan
16110023|NCT02088775|Procedure|hepatic artery embolization|Undergo standard radioembolization
16110024|NCT02088762|Procedure|surgical excision|comparison of safety margin 1 versus 2 cm
16110025|NCT02088749|Behavioral|lifestyle intervention for obesity|
16110026|NCT02088736|Device|Intraosseous|
16110027|NCT02088736|Device|Intravenous|
16110028|NCT02088723|Behavioral|Head of bed elevation|head of bed elevation elevation the head of the bed with 15 cm (head of bed elevation) and compare the apnea-hypopnea index with the standard polysomnography
16110029|NCT02088710|Behavioral|Enhanced information about endocrine therapy|Enhanced information about endocrine therapy, extending clinical routine information
16110030|NCT02088697|Drug|Placebo|
16110031|NCT02088697|Drug|ASC-01|
16110032|NCT02088684|Drug|LEE011|LEE011: supplied as capsules of dosage strength of 50 mg or 200 mg. The capsules will be differentiated through different sizes
16110033|NCT02088684|Drug|BYL719|BYL719: supplied as tablets of dosage strength of 10 mg, 50 mg or 200 mg. Tablets will be differentiated through different sizes and/or colors.
16110034|NCT02088684|Drug|fulvestrant|Fulvestrant will be supplied according to local practice and regulation. Fulvestrant is a commercially available product, comes in 500 mg dose and is an injection for intramuscular (i.m.) administration.
16110035|NCT02088684|Drug|BKM120|BKM120: supplied as 10 mg or 50 mg capsules. The capsules will be differentiated through different sizes.
16110036|NCT02088671|Drug|Propofol induction followed by randomized doses of desflurane|Anesthesia in all patients will be induced with iv propofol 1.5 mg/kg with extra 0.5 mg/kg doses as needed. Anesthesia will be maintained using inhaled desflurane in oxygen/air with the initial desflurane concentration of 1.2 MAC, which will be changed in steps of ±0.4 MAC after reaching the post-intubation steady state. The step changes will be initiated every 7.5 min, as follows: at every level of MAC there is a 1/3 chance in remaining at this level and a 2/3 chance of changing it. The anesthesiologist can accept the change to move to the new level. However, he/she can also reject it to remain at the current level for another 7.5 min. This scheme yields 3 possible desflurane levels: 0.8, 1.2 and 1.6 MAC. The anesthesiologist can also leave the randomization schedule at anytime if clinically indicated, and later re-start it at his/her discretion. All anesthetic doses and their changes fall within conventional dosing.
16110037|NCT02088671|Device|Recording of EEG using NeuroSENSE|"The NeuroSENSE NS-701 system is a 2-channel device for brain activity monitoring in the operating room, intensive care unit, emergency room and other clinical settings. The system acquires and processes electroencephalograms (EEGs) via noninvasive electrodes placed on a patient's forehead. The acquired raw EEG signals and processed EEG variables are continuously displayed for interpretation by the clinician.
~The proprietary processed variable, WAVcns, quantifies the patient's brain activity, which is typically affected by anesthetic drugs. The system displays processed variables based on 2 bilateral channels (1 per brain hemisphere) for use as a supplement to the anesthesia standard of care.
~Note: the indications provided by the NeuroSENSE monitor are not used for anesthesia dosing or patient assessment in this study, and the anesthesia provider is blinded to the monitor readings. The device is used only for acquisition of EEG signals and may be used to log the events of interest."
16110074|NCT02088411|Other|Placebo|
16110075|NCT02088398|Drug|ACY-1215|
16110076|NCT02088385|Device|Hemospray|
16110077|NCT02088385|Device|Combined Conventional Technique|
16110079|NCT02088359|Other|Cycled light|We covered the incubator with blanket for darkness approximately 12 hours.
16110080|NCT02088359|Other|Continue near darkness|We covered the incubator with blanket all days.
16110081|NCT02088346|Other|Telemedicine consultation system|Telemedicine consultation system based on portable hardwares
16110038|NCT02088671|Other|Data collection|"Non-invasive blood pressure (BP), heart rate (HR), respiratory rate (RR) and electroencephalogram (EEG) will be recorded during the surgery in all subjects. Also, information about all medically significant events, all study-related events (incl. patient's reactions, responses, observations and assessments) and administered medications (incl. end-tidal (ET) desflurane concentration) will be recorded along with time stamps.
~The anesthesia and physiological parameters (e.g., BP, HR, RR, ET agent concentration) outputted from the anesthesia monitor will be recorded electronically during the surgery by the anesthesia monitoring system (data-points will be recorded at least every 3 min for BP and every 10 sec for other variables).
~The EEG signal will be continuously recorded by NeuroSENSE NS-701 Monitor (described under a separate intervention).
~The CRC will also be present in the Operating Room (OR) to record and manage the recording of all the required information."
16110039|NCT02088671|Other|Drug: Emergence by stepping down the desflurane ET|Anesthesia will be reduced to facilitate rapid recovery at the discretion of the anesthesiologist, about 20 minutes before the end of surgery. The desflurane ET will be stepped down from 0.8 MAC by steps of 0.2 MAC approximately every 5 min during the Emergence.
16110040|NCT02088658|Behavioral|Technology Intensified|The intervention is based on the Information-Motivation-Behavioral Skills (IMB) model and provides information, motivation, and behavioral skills training (using motivational enhancement techniques). Patients will be assigned the FORA 2-in-1 Telehealth System and provided glucose test strips to allow testing at least once a day. They will be asked to perform glucose testing and blood pressure measurement using the FORA system once daily. They will be asked to upload the measurements daily as soon as possible after the test is performed. The nurse educators will have access to a secure server to which the uploaded measurements are stored in real time. The glucose and BP readings will be used to tailor and reinforce behavior change during weekly telephone-delivered diabetes education sessions.
16110041|NCT02088645|Drug|177Lu-PP-F11N|
16110042|NCT02088632|Biological|Incobotulinumtoxina|Incobotulinumtoxina (Xeomin) is botulinum toxin type A and is administered via intramuscular injection.
16110043|NCT02088632|Other|Placebo Comparator|Normal saline is sterile sodium chloride without and preservatives.
16110044|NCT02088619|Behavioral|Quality of Life Therapy (QOLT)|
16110045|NCT02088619|Behavioral|Heart Healthy Education (HHE)|
16110046|NCT02088593|Device|Simulated Dawn Light Box|per3 model of Naturebright It was set at the participants habitual wake time, and automatically began ramping between 30 and 90 minutes prior to that time (based upon participant preference). The ramp increased in a curvilinear fashion, mimicking sunrise during the summer at 45 degrees North latitude and reached a maximum light intensity of 300lux. They were allowed to switch the lamp off during the ramp period, and sleep in on off days, but were asked to allow the light to begin its ramp.
16110047|NCT02088593|Behavioral|Sleep Hygiene instructions|Sleep Hygiene instructions read aloud
16110048|NCT02088580|Procedure|Triple Chronotherapy|
16110049|NCT02088567|Procedure|Total Knee Arthroplasty|Total knee arthroplasty, per the usual practice of the physician.
16110050|NCT02088567|Other|Application of dHACM|Application of dHACM at end of procedure before closing wound between the underlying fascia and the overlying skin layers to reduce scar formation
16110052|NCT02088541|Drug|Selinexor|Selinexor oral tablet.
16110053|NCT02088541|Drug|Hydroxyurea|
16110054|NCT02088541|Drug|Ara-C|Ara-C Subcutaneous Injection.
16110055|NCT02088528|Device|Aurolab glaucoma drainage device|Patients undergoing surgery will receive an implant
16110056|NCT02088528|Procedure|Trabeculectomy with mitomycin-c|Trabeculectomy surgery augmented by application of mitomycin C (0.4 mg/ml) to the sclera in the region of the trabeculectomy site for a period of exactly 3 minutes.
16110057|NCT02088515|Drug|Nedaplatin|
16110058|NCT02088515|Drug|Cisplatin|
16110059|NCT02088515|Drug|Docetaxel|
16110060|NCT02088502|Drug|N-acetylcysteine|
16110061|NCT02088502|Drug|Theophylline|
16110062|NCT02088502|Drug|0.9% sodium chloride|All patients are hydrated with 0.9% sodium chloride (1 mL/kg/hour) for 24 hours, 12 hours before operation. Patients with left ventricular ejection fraction less than 40% or New York Heart Association functional class III-IV, are hydrated with 0.5 mL/kg per hour.
16110063|NCT02088489|Device|Atrial flutter irrigated catheter|A duodecapolar isthmic curve catheter will be introduced to demonstrate cavo-tricuspidal bidirectional block. We performed atrial flutter ablation with conventional irrigated Thermocool® (Biosense Webster, Diamond Bar, CA) catheter Continuous lesions from tricuspidal annulus to inferior vena cava will be realized and then complete isthmic block will be confirmed by bidirectional stimulation
16110064|NCT02088489|Device|Atrial flutter porous tip catheter|A duodecapolar isthmic curve catheter will be introduced to demonstrate cavo-tricuspidal bidirectional block. We performed atrial flutter ablation with Porous tip Thermocool® SF(Biosense Webster, Diamond Bar, CA)irrigated catheter Continuous lesions from tricuspidal annulus to inferior vena cava will be realized and then complete isthmic block will be confirmed by bidirectional stimulation
16110065|NCT02088463|Procedure|mobilization (manual therapy)|mobilization is one of the manual therapy or treatments with the application of a gentle oscillatory passive movement to the spinal region specifically at the level of L3 in this study at the posterio-anterior direction.
16110066|NCT02088463|Procedure|Placebo mobilization|placebo mobilization is a tactile stimulation at the same level L3 without application of any force.
16110067|NCT02088463|Device|Ultrasound and infrared devices|ultrasound and infrared are the traditional treatment for low back pain , they are electrical modalities used in the field of physiotherapy to decrease the inflammation and the pain in musculoskeletal systems
16110068|NCT02088450|Drug|Active treatment with nitrendipine (10-40 mg/day).|If necessary, the dihydropyridine calcium-channel blocker was combined with or replaced by enalapril maleate (5-20 mg/day), hydrochlorothiazide (12.5-25 mg/day), or both drugs.
16110069|NCT02088437|Other|Intensive physiotherapy|additional once daily physiotherapy and once daily allied health assistant intervention (equals two more treatments) whilst an inpatient in acute hospital
16110070|NCT02088437|Other|Usual Care|once daily physiotherapy whilst acute hospital inpatient
16110071|NCT02088424|Other|insulin resistance(fasting glucose/fasting insulin)|insulin resistance(fasting glucose/fasting insulin )
16110072|NCT02088411|Drug|Diclofenac|
16110073|NCT02088411|Dietary Supplement|Wobenzym|
16110082|NCT02088333|Behavioral|mCRC intervention|a multilevel intervention consisting of tablet-based patient education about CRC screening, post-visit patient electronic messaging, and clinic protocols to facilitate ordering of screening tests
16110083|NCT02088333|Behavioral|Healthy Lifestyles video|a brief video about healthy lifestyle habits displayed on a tablet device
16110084|NCT02088307|Dietary Supplement|CardioLife|Participants randomized to treatment arm will take dietary supplement as instructed.
16110085|NCT02088294|Behavioral|Lifestyle Education (LS)|See arm description
16110086|NCT02088294|Behavioral|LS + Stress Reduction Guided Imagery|See Arm Description
16110087|NCT02088294|Behavioral|LS + Activity/Eating Guided Imagery|See arm description
16110088|NCT02088281|Drug|Indigo naturalis extract in oil ointment|Apply 0.5 g of INEO ointment per 10 x 10 cm psoriasis lesion twice daily.
16110089|NCT02088268|Other|wound healing|wound healing
16110090|NCT02088255|Procedure|Static surface|During all session time the subject will walk on the floor with partial body weight support. This protocol will be repeated in all sessions.
16110091|NCT02088255|Procedure|Dynamic surface|During all session time the subject will walk on the treadmill with partial body weight support. This protocol will be repeated in all sessions.
16110092|NCT02088242|Drug|Astaxanthin|Oral supplementation with the food supplement Astaxanthin. Subjects receiving Astaxanthin will be asked to ingest 3 capsules containing 4mg of Astaxanthin each (a daily dose of 12mg).
16110093|NCT02088242|Drug|Placebo|3 capsules identical in shape, colour and size to the Astaxanthin capsules, which contain only the inactive ingredients of the same formulation.
16110094|NCT02088216|Drug|N-acetylcysteine|600mg po twice a day for 12 months
16110095|NCT02088216|Other|On-demand treatment|receive as-needed therapy
16110096|NCT02088203|Dietary Supplement|Dose 1|Russian Tarragon Nutrasorb 0.3 g
16110097|NCT02088203|Dietary Supplement|Dose 2|Russian Tarragon Nutrasorb 1 g
16110098|NCT02088203|Dietary Supplement|Dose 0|Placebo
16110099|NCT02088203|Dietary Supplement|Dose 3|Russian Tarragon Nutrasorb 3 g
16110100|NCT02088203|Dietary Supplement|Dose 4|Russian Tarragon Nutrasorb 10 g
16110101|NCT02088203|Dietary Supplement|Dose 5|Russian Tarragon Nutrasorb 20 g
16110102|NCT02088203|Dietary Supplement|Dose 6|Russian Tarragon Nutrasorb 30 g
16110103|NCT02088190|Procedure|Sleeve gastrectomy|Type of bariatric surgery
16110104|NCT02088177|Drug|Long-acting injectable naltrexone|Vivitrol is a long-acting opioid antagonist which blocks opioid agonists from binding at opioid receptors. It be administered as described above.
16110105|NCT02088151|Device|Selective retinal pigment epithelium laser therapy using the R:GEN Laser System|Patients receive selective retinal pigment epithelium laser treatment using the R:GEN Laser System by Lutronic Corporation, Korea.
16110106|NCT02088138|Device|Functional Electrical Stimulation|Functional electrical stimulation twice per week for eight weeks totaling sixteen sessions.
16110107|NCT02088138|Device|Functional Electrical Stimulation placebo|Functional electrical stimulation in the sensory threshold level, twice a week for eight weeks, totaling sixteen sessions.
16110108|NCT02088125|Other|Breath Stacking|Breath Stacking A mask was used with two one-way valves (inspiratory limb and expiratory limb), which was coupled to the patient's face allowing only inspiration, while the expiratory branch remained occluded for the individual only perform successive inspiratory efforts.
16110109|NCT02088125|Other|Incentive Spirometry|The Incentive Spirometry was characterized by the use of the incentive spirometer volume, in which volunteer used a nasal clip and was instructed to inhale slowly and deeply through the mouthpiece of the equipment from functional residual capacity to total lung capacity.
16110110|NCT02088112|Drug|Gefitinib|Gefitinib QD
16110111|NCT02088112|Drug|MEDI4736|MEDI4736 IV Q2W
16110112|NCT02088099|Other|Complex clinical intervention|The complex intervention in CONNECT will be tested in 3 target populations: (1) Individuals hospitalized for TBI; (2) their family members; (3) their local health care providers. All intervention components will be delivered remotely: there will be no face-to-face interaction with the research subjects. The complex intervention tested in CONNECT is comprised of the clinical direction and advice to local providers, educational, and supportive services of the Mayo Brain Rehabilitation Clinic (BRC). The specific communication modes used to interact with individual study subjects, and the specific clinical and educational support services that are provided to an individual subject by these modes, will be determined by clinical need, individual preference, and technological capacity.
16110113|NCT02088099|Other|Treatment as usual|Participants in this arm will receive, experience, or provide the care that is usual and customary in their communities.
16110114|NCT02088086|Behavioral|BMI screening|Students in grades 3-8 will have their heights and weights measured annually at school and their BMIs calculated.
16110115|NCT02088086|Behavioral|BMI reporting|Schools will send a report home to parents that provides their child's height, weight, and BMI results.
16110116|NCT02088086|Behavioral|Fitness testing|Students in grades 5-8 will participate in five fitness assessments (curl-ups, sit-ups, push-ups, sit-and-reach, and the PACER test or mile run) annually at school.
16110117|NCT02088073|Drug|Sodium zirconium cyclosilicate|Sodium zirconium cyclosilicate
16110118|NCT02088073|Drug|Placebo|Randomized to mimic doses of experimental drug administered once daily with breakfast for 28 days (maintenance phase)
16110119|NCT02088060|Drug|Cannabidiol|Cannabidiol capsules
16110120|NCT02088060|Drug|Olanzapine|Olanzapine capsules
16110121|NCT02088060|Drug|Placebo Cannabidiol|Placebo cannabidiol capsules
16110122|NCT02088060|Drug|Placebo Olanzapine|Placebo olanzapine capsules
16110123|NCT02088047|Device|ProFoveate|ProFoveate™ intervention for nystagmus is a management approach comprised of non-magnetic, 1.2 mm spheres that can be made from either stainless steel, gold plated stainless steel or titanium, placed strategically about the face and ears and a set of exercises designed to support improved vision for patients with nystagmus.The spheres (i.e., stimulating press balls or pellets) are supplied in packages of 20 with each sphere supplied on a transparent hypoallergenic adhesive tape approximately 7.6 mm in diameter. Within each package, all spheres are individually contained on a single paper backing measuring approximately 8.5 cm by 1.7 cm. Individual pellets (with adhesive tape) are removed from the backing as needed according to the prescribed treatment regimen.
16110566|NCT02084706|Procedure|J-tip lidocaine administration|
16110124|NCT02088034|Behavioral|Promotora-led Intervention|Behavioral life-style program lead by a team of trained community health workers (called promotoras) with 2 principal goals - encouraging participants to lose 7% of their total weight and complete 150 minutes of moderate physical activity per week.
16110125|NCT02088034|Drug|Metformin Therapy|Participants in this group will receive metformin 850 mg bid for one year.
16110126|NCT02088034|Other|Usual Care|Participants in this arm will attend one physician visit to discuss healthy lifestyle behaviors and will receive standard educational materials.
16110127|NCT02088021|Device|Portico Transcatheter Aortic Valve|Placement of the SJM Portico aortic valve with a ALC delivery system
16110128|NCT02088008|Drug|cinidipine, valsartan|
16110129|NCT02087995|Device|Continuous Glucose Monitoring|A prescribed clinic session day for participating subjects.
16110130|NCT02087969|Procedure|Dry Needling|
16110131|NCT02087969|Procedure|Stretching|
16110132|NCT02087956|Behavioral|Navigation|The navigator provides up to 4 months outreach and support to implement the personal care plan. Patients determine the preferred frequency and type of contact with the navigator. . At the end of the four months, the patient and navigator will review the personal care plan, and the navigator will work with the patient as to how she can continue progress through accessing other supports and resources as needed.
16110133|NCT02087956|Behavioral|Enhanced Screening and Referral|Patients assigned to ESR will be provided with a print-out of their Promote-W comprehensive health screening results. More specifically, they will receive a list of concerns they endorsed plus a resource list of locations where they can obtain assistance with those issues, which are largely free.
16110134|NCT02087943|Drug|Apremilast|Orally twice a day (BID)
16110135|NCT02087943|Drug|Apremilast|Orally twice a day (BID)
16110136|NCT02087943|Drug|Placebo|Orally twice a day (BID)
16110137|NCT02087943|Drug|Placebo|Orally twice a day (BID)
16110138|NCT02087917|Drug|HS-25|Assigned study drug (HS-25 or placebo) is to be administered orally once daily in the morning with or without food. Treatment duration 4 weeks.
16110139|NCT02087917|Drug|Placebo|Assigned study drug (HS-25 or placebo) is to be administered orally once daily in the morning with or without food. Treatment duration 4 weeks.
16110140|NCT02087904|Biological|ABT-981|
16110141|NCT02087904|Other|Placebo|
16110142|NCT02087891|Behavioral|Web-based Stress Management Program (WSM)|The intervention, developed by the Cleveland Clinic, is an 8-week online, interactive, educational program based on mindfulness meditation. Briefly, each week subjects are introduced to the (1) weekly audio introduction to the mindfulness theme or particular meditation technique of the week, (2) weekly audio meditation techniques for relaxation, (3) daily articles providing scientific evidence and merits of meditation, and (4) bi-weekly email reminders. The introductory talks and meditation exercises were also provided on compact discs (CD) in mp3 format.
16110143|NCT02087891|Behavioral|Group Support (WSMg1)|Subjects will meet once per week for 1 hour during the 8-week duration and practice 2-minutes of deep breathing exercises, listen to 10-minutes audio recording of the weekly lesson and practice 20-30 minutes guided meditation exercise. The remainder of the time will be used to foster sharing experiences and answering specific questions related to the weekly lesson.
16110144|NCT02087891|Behavioral|Clinical Expert Support (WSMg2)|A clinical psychologist will replace the non-expert facilitator during 4 group support sessions.
16110145|NCT02087865|Drug|donepezil HCL|
16110146|NCT02087865|Drug|Placebo|
16110147|NCT02087852|Other|salvia for germline DNA|
16110148|NCT02087852|Behavioral|the Kidney Cancer Questionnaire|Patients will complete the appropriate surveys on either paper or on the computer/iPad in the office using REDCap software. If patients are unable to complete their questionnaires at the time of their in-office visit, a link to the questionnaires in REDCap will be emailed to them. The survey data that is collected in REDCap will be stored in REDCap. Clinic staff may also call patients to remind patients to complete questionnaires.
16110149|NCT02087852|Behavioral|Family History Questionnaire (when applicable)|Patients will complete the appropriate surveys on either paper or on the computer/iPad in the office using REDCap software. If patients are unable to complete their questionnaires at the time of their in-office visit, a link to the questionnaires in REDCap will be emailed to them. The survey data that is collected in REDCap will be stored in REDCap. Clinic staff may also call patients to remind patients to complete questionnaires.
16110150|NCT02087852|Other|Blood draw|
16110151|NCT02087852|Behavioral|Epidemiologic Questionnaire|Patients will complete the appropriate surveys on either paper or on the computer/iPad in the office using REDCap software. If patients are unable to complete their questionnaires at the time of their in-office visit, a link to the questionnaires in REDCap will be emailed to them. The survey data that is collected in REDCap will be stored in REDCap. Clinic staff may also call patients to remind patients to complete questionnaires.
16110152|NCT02087826|Other|Mixed Meal Tolerance Test|The meal will provide a standard amount of total calories, protein, fat, and carbohydrate to each participant at both study visits. Pre-packaged and prepared food, weighed to the nearest gram, will be used.
16110153|NCT02087826|Drug|Metformin|Metformin will be administered during this study. This medication is safely prescribed at a maximum dose of 1000 mg twice daily for the treatment or prevention of type 2 diabetes, as well as for other metabolic conditions. To minimize potential side effects of metformin (e.g., GI upset), participants will take ½ the maximum dose of this medication (500 mg twice daily) and for only 5 days. Participants will be informed of the potential side effects of metformin. They will be asked to contact study staff and discontinue the medication if symptoms are very uncomfortable.
16110154|NCT02087813|Drug|Alpha1-antitrypsin|
16110155|NCT02087813|Drug|methylprednisolone|3-5 days 1000mg IV methylprednisolone at first presentation with acute attack.
16110156|NCT02087800|Behavioral|F phase lab session|F phase sessions will occur three to seven days post the onset of menses. It will include blood draws, an acute stressor and completion of questionnaires.
16110157|NCT02087800|Behavioral|L phase lab session|L phase sessions will occur six to ten days prior to the onset of the next expected menses. It will include blood draws, an acute stressor and completion of questionnaires.
16110158|NCT02087787|Behavioral|BMT Legal Clinic|2 hour consultation with an attorney in the BMT Legal Clinic with potential follow-up as needed.
16110159|NCT02087774|Behavioral|6 minutes activity|Group added 6 minutes of physical activity daily during school day.
16110160|NCT02087748|Drug|1% diclofenac sodium gel|Diclofenac sodium 1% gel 4 grams applied topically Q6 hour for 48 hours
16110161|NCT02087748|Drug|Placebo|Placebo gel 4gm applied topically Q6 hour for 48 hours
16110162|NCT02087735|Dietary Supplement|Cranberry extract|The aim of this pilot study is to evaluate the urinary catabolites of PACs as a biomarker of consumption of cranberry extracts within 9 hours of intercourse. Once a week, for 3 weeks, the women will receive a sequence of 3 different cranberry extracts (72 mg, 36 mg and 2mg (placebo)). The participant will have to collect its urine for a period of 9 hours in 3 different containers (one different container for 3 hours).
16110163|NCT02087722|Drug|KI1001|
16110164|NCT02087722|Drug|Placebo|
16110165|NCT02087709|Other|Low-calorie diet|
16110166|NCT02087696|Drug|Tocilizumab|Tocilizumab dose 8mg/kg administered every 4 weeks during 24 weeks.
16110167|NCT02087683|Other|Vitamin D Supplementation|Participants in this group will receive vitamin D supplements of 5 000 International units per day for 12 months. Each patient will attend their respective clinic for clinical evaluation by their cardiologist, whom will give them the vitamin supply for a month.
16110168|NCT02087683|Other|Control group (Placebo)|Participants in this group will receive a placebo made of gelatin and corn oil per day for 12 months. Each patient will attend their respective clinic for clinical evaluation by their cardiologists, whom will give the vitamin supply for a month.
16110169|NCT02087670|Other|controlled, supervised exercise protocol|exercise program within a cardiac rehabilitation program
16110170|NCT02087670|Other|exercise protocol no supervised|Exercise program at the community
16110171|NCT02087657|Device|Administration of hyperbaric oxygen|Hyperbaric oxygen at 2.5 atmospheres absolute (ATA) for a total of 2 hours
16110172|NCT02087644|Biological|CYT003|Injections
16110173|NCT02087644|Biological|Placebo|Injections
16110174|NCT02087631|Drug|Extended-release quetiapine fumarate|Dosing schedule for RRMS: Group 1: Day 1-3:50 mg Day 4-6:100 mg Day 7-28:150 mg Day 29-30:100mg Day 31-32:50mg; Group 2: Day 1-2:50 mg Day 3-4:150 mg Day 5-6:200 mg Day 7-28:300 mg Day 29-30:250mg Day 31-32:200mg Day 33-34:150mg Day 35-36:100mg Day 37-38:50mg; Group 3: Day 1:50 mg Day 2:100 mg Day 3:200 mg Day 4-28:300 mg Day 29-30:250mg Day 31-32:200mg Day 33-34:150mg Day 35-36:100mg Day 37-38:50mg Dosing schedule for progressive MS: Group 1: Day 1-14: 50 mg Day 15-28: 100 mg Day 29-30: 50mg; Group 2: Day 1-5: 50 mg Day 6-10: 100 mg Day 11-15: 150 mg Day 16-28: 200 mg Day 29-30: 150mg Day 31-32: 100mg Day 33-34: 50mg; Group 3: Day 1-5: 50 mg Day 6-10: 100 mg Day 11-15: 200 mg Day 16-28: 300 mg Day 29-30: 250mg Day 31-32: 200mg Day 33-34: 150mg Day 35-36: 100mg Day 37-38: 50mg
16110175|NCT02087618|Other|Kodro+|Kodro+ participants will utilize Kodro Solution on a tablet for 30 minutes a day for 36 weeks
16110176|NCT02087618|Other|Kodro+D|Kodro+D participants will utilize the Kodro Solution program 12-weeks post-baseline for 30 minutes per day for 24-weeks
16110177|NCT02087592|Behavioral|Structured exercise training plus mediterranean diet|
16110178|NCT02087579|Drug|Aripiprazole, oral formulation|Aripiprazole tablets will be administered orally (by mouth), at no dose restriction, as per the locally approved label indications.
16110179|NCT02087579|Drug|Olanzapine, oral formulation|Olanzapine tablets will be administered orally, at no dose restriction as per the locally approved label indications.
16110180|NCT02087579|Drug|Paliperidone, oral formulation|Paliperidone prolonged-release/extended-release (XR) formulation tablets will be administered orally, at no dose restriction, as per the locally approved label indications.
16110181|NCT02087579|Drug|Paliperidone, LAI|Paliperidone long-acting injectable (LAI) i.e., paliperidone palmitate injections, will be administered per the locally approved label indications.
16110182|NCT02087579|Drug|Quetiapine, oral formulation|Quetiapine immediate-release (IR) formulation or extended-release (XR) formulation tablets will be administered orally, at no dose restriction, as per the locally approved label indications.
16110183|NCT02087579|Drug|Risperidone, oral formulation|Risperidone tablets will be administered orally, at no dose restriction, as per the locally approved label indications.
16110184|NCT02087579|Drug|Risperidone, LAI|Risperidone LAI injections will be administered will be administered per the locally approved label indications.
16110185|NCT02087566|Drug|600 mg linezolid|
16110186|NCT02087553|Biological|Transfusion of red blood cells|(non-experimental) PRBC transfusion
16110187|NCT02087553|Biological|Infusion of albumin/saline|(non-experimental) albumin/saline infusion
16110188|NCT02087540|Drug|Telmisartan 80mg|
16110189|NCT02087540|Drug|Rosuvastatin 20mg|
16110190|NCT02087540|Drug|Rosuvastatin 10mg|
16110191|NCT02087540|Drug|Placebo(for Telmisartan 80mg)|
16110192|NCT02087540|Drug|Placebo(for Rosuvastatin 20mg)|
16110193|NCT02087540|Drug|Placebo(for Rosuvastatin 10mg)|
16110194|NCT02087527|Drug|Dexamethasone|IV Dexamethasone 0.15 mg/kg every 6 hours for 48 hours
16110195|NCT02087527|Drug|Normal Saline|IV normal saline every 6 hours for 48 hours
16110196|NCT02087514|Procedure|Blood Transfusion|A routine medical procedure in which blood is given through an intravenous (IV) line a blood vessel.
16110197|NCT02087514|Other|Packed red blood cells|"Red blood cells that have been collected, processed, and stored in bags as blood product units available for blood transfusion.
~A standard autologous leukoreduced packed red blood cell unit will be collected and stored in AS-3 solution in the Columbia University Medical Center blood bank.
~The number of weeks in storage are as follows:
~1 week
~2 weeks
~3 weeks
~4 weeks
~5 weeks
~6 weeks"
16110198|NCT02087501|Device|Horizon™ Abdominal Aortic Aneurysm Stent Graft System|All patient eligible to undergo stent implantation will receive the Horizon™ Abdominal Aortic Aneurysm Stent Graft System and its designated Delivery System.
16110199|NCT02087488|Other|auricular acupuncture(AA)|"Auricular acupoints: Shenmen (TF4), Heart (CO15), Subcortex (AT4), modifying points according to different patterns.
~Auricular attachment material: disposable Seirin Pyonex Needle Seirin Pyonex Needle manufacturer: Seirin Corporation, a Japanese company. Medical Device Certification number: No. 15500BZZ00806000.
~Treatment frequency: every 3 days.
~Duration: 4 weeks."
16110200|NCT02087488|Other|placebo AA|"Auricular acupoints: Wrist (SF1), Clavicle (SF6), Shoulder (SF4、5), Tooth (LO1), Tonsil (LO7, 8, 9).
~Auricular attachment material: the disposable Pyonex Zero Needle Pyonex Zero Needle manufacturer: Seirin Corporation, a Japanese company.
~Treatment frequency: every 3 days.
~Duration: 4 weeks."
16110384|NCT02086019|Procedure|Invasive Arm|angiogram with PCI or CABG revascularisation if appropriate
16110201|NCT02087488|Drug|Eszopiclone|"Dosage form: tablet.
~Dosage: 1 piece (3mg).
~Drug manufacturer: Kanghong pharmaceutical limited liability company, Chengdu.
~Production license: NO. H20100074 approved by the state.
~Treatment frequency: 15 mins before going to bed everyday.
~Duration: 4 weeks."
16110202|NCT02087475|Drug|Irinotecan|
16110203|NCT02087475|Drug|5-fluorouracil|
16110204|NCT02087475|Radiation|Local radiotherapy|
16110205|NCT02087475|Procedure|R0 resection|
16110206|NCT02087462|Other|Electroacupuncture (EA)|"Main acupoints: Da chang shu (BL25), Huan tiao (GB30), bilateral Jiaji point of attacked lumbar vertebra, Ashi points, modifying points according to different patterns.
~Electroacupuncture: choose the dilatational wave, frequency is 2Hz/100Hz, electric current ranges from 0.1mA to 1.0mA, 30 mins per time.
~Treatment frequency: 5 times per week in the first 2 weeks, 3 times per week in the 3rd and 4th week, 2 times per week in the 5th and 6th week.
~Duration: 6 weeks."
16110207|NCT02087462|Other|Traction|An electric pelvis traction in supine position will be applied. The treatment frequency and duration are the same as EA.
16110208|NCT02087462|Drug|Voltaren|"Medication: 50 mg, twice per day
~Treatment frequency: In the first 2 weeks, take medicine for continuous 5 days with a 2-day interval each week; in the 3rd and 4th week, take medicine every 2 days, totally 3 times each week; in the 5th and 6th week, take medicine every 3 days, totally 2 times each week.
~Duration: 6 weeks."
16110209|NCT02087462|Drug|Vitamin B1|"Medication: 10mg, twice per day.
~Treatment frequency: In the first 2 weeks, take medicine for continuous 5 days with a 2-day interval each week; in the 3rd and 4th week, take medicine every 2 days, totally 3 times each week; in the 5th and 6th week, take medicine every 3 days, totally 2 times each week.
~Duration: 6 weeks."
16110211|NCT02087436|Device|Taperloc Complete Microplasty|Taperloc Complete Microplsty cementless stem is designed to transmit load to the proximal femur, thereby preserving bone density, and preventing long term instability and loosening secondary to proximal bone resorption.
16110212|NCT02087436|Device|Taperloc Complete Standard|Taperloc Complete Standard is designed after the philosophy of a flat tapered wedge. It has evolved to incorporate the Reduced Distal and Microplasty stems to better address all patient anatomies, and facilitate multiple surgical techniques.
16110213|NCT02087423|Drug|MEDI4736|MEDI4736 (durvalumab) by intravenous infusion every two weeks. Treatment from Day 1 for a maximum of 12 months or study drug withdrawal if this occurs earlier. Patients who achieve CR, PR or SD through the end of the initial 12-month treatment period can restart treatment with MEDI4736 (durvalumab) when they eventually do progress. This retreatment period can continue for as long as the investigator considers to patient to be receiving clinical benefit.
16110214|NCT02087397|Other|Liposuction|Liposuction using aspiration syringe and tumescent local anesthesia
16110215|NCT02087397|Biological|AD-SVF Cell Injection|Stem cell implantation will be performed using direct injection into the Corpus Cavernosum with local anesthesia
16110216|NCT02087384|Biological|Gardasil|Intramuscular Gardasil vaccination at 0, 2 and 6 months.
16110217|NCT02087384|Drug|Placebo|injection of 0.9% saline
16110218|NCT02087332|Drug|Prolonged release Torasemide (Britomar)|
16110219|NCT02087332|Drug|Torasemide (Diuver)|
16110220|NCT02087319|Other|hair loss, baldness (patient's own platelet-rich plasma)|hair loss, baldness
16110221|NCT02087306|Drug|Brincidofovir|BCV administered twice weekly, dose depending on weight.
16110222|NCT02087293|Behavioral|Intervention arm - automated call and phone-based pharmacist counseling|patients receive automated phone call with questions about side effects and an opportunity to speak with a pharmacist
16110223|NCT02087267|Procedure|1- or 2-level spinal fusion|1- or 2-level lumbar or lumbar-sacral spinal fusion with the icotec CF/PEEK Pedicle System in combination with the icotec CF/PEEK TLIF Cage ETurn™
16110224|NCT02087241|Drug|AZD1775|AZD1775 is a highly selective, adenosine-triphosphate (ATP) competitive, small molecule inhibitor of the WEE 1 kinase that sensitizes tumor cells to cytotoxic agents and is being developed for the treatment of advanced solid tumors and p53 pathway deficient malignancies
16110225|NCT02087241|Drug|AZD1775 Matching Placebo|AZD1775 is a highly selective, adenosine-triphosphate (ATP) competitive, small molecule inhibitor of the WEE 1 kinase that sensitizes tumor cells to cytotoxic agents and is being developed for the treatment of advanced solid tumors and p53 pathway deficient malignancies
16110226|NCT02087241|Drug|pemetrexed|This drug is a part of a general group of chemotherapy drugs called anti-metabolites. It prevents cells from using folate to make DNA and RNA. Because cancer cells need these substances to make new cells, this drug helps to stop the growth of cancer cells.
16110227|NCT02087241|Drug|carboplatin|This drug is a platinum chemotherapy drug that acts like an alkylating agent. It stops the growth of cancer cells, causing the cells to die.
16110228|NCT02087228|Device|Genesys HydroTherm Ablator|Heated water is circulated inside the uterus to destroy the lining of the uterus
16110229|NCT02087228|Device|radiofrequency energy ablation device|
16110230|NCT02087215|Drug|boron gel|application of a formulation gel: addition of borate as sodium penta boric acid pentahydrate 3% (w/v) and two different copolymer as pluronic block namely F68 2% (w/v) and f127 2% (w/v) to diabetic foot ulcers.
16110231|NCT02087215|Drug|Placebo|
16110232|NCT02087202|Drug|Magnesium Sulfate|magnesium sulfate is added to the patients
16110233|NCT02087202|Drug|ketamine|ketamine is added to the patients.
16110234|NCT02087189|Device|First ICD/CRT-D implantation or upgrade from pacemaker|
16110235|NCT02087176|Drug|AZD1775|AZD 1775 + antimitotic agent+ pegfilgrastim, restage every 2 cycles; continue until disease progression or unacceptable toxicity
16110236|NCT02087176|Drug|AZD1775 Placebo|Placebo (to match dose) + antimitotic+ pegfilgrastim, restage every 2 cycles; continue until disease progression or unacceptable toxicity
16110237|NCT02087176|Drug|Antimitotic Agent|The antimitotic is a drug that stops cells from dividing. This leads to cell death. Because cancer cells divide faster than normal cells, they are more likely than normal cells to be affected by this drug.
16110238|NCT02087176|Drug|pegfiligrastim|Pegfilgrastim is a man-made version of a protein called granulocyte-colony stimulating factor (G-CSF). This protein is made by cells in the body to stimulate the bone marrow to make more infection-fighting white blood cells.Pegfilgrastim is made by attaching filgrastim to a molecule called polyethylene glycol (PEG). This addition helps it stay in the body longer than filgrastim, which means it can be given less often.
16110239|NCT02087163|Device|Movement Enhancement Technique|Conventional Orthodontic treatment
16110240|NCT02087163|Device|Clear Aligner|Orthodontic treatment with Clear Aligner
16110241|NCT02087150|Device|Acclarent Eustachian Tube Balloon Catheter (ETBC)|
16110242|NCT02087137|Behavioral|Memory and Aging Program|
16110243|NCT02087124|Other|Whey protein|Different amounts of whey protein dissolved in 200 mL water.
16110244|NCT02087111|Drug|Telaprevir|375 mg film coated tablets
16110245|NCT02087111|Drug|40 Kd Pegylated interferon alfa 2a|180 µg in pre-filled syringe for sub-cutaneous injection
16110246|NCT02087111|Drug|Ribavirin|200 mg tablets
16110247|NCT02087098|Drug|Solifenacin|Patients with residual OAB symptoms (urge urinary incontinence, urgency, and frequency) after treatment with other antimuscarinics
16110248|NCT02087085|Drug|400 µg Brimonidine Implant|400 µg brimonidine implant in the study eye using Brimo DDS® applicator on Day 1, and every 3 months through Month 21.
16110249|NCT02087085|Other|Sham|Sham treatment with needleless applicator (no implant) to the study eye on Day 1, and every 3 months through Month 21.
16110250|NCT02087072|Other|Collaborative visit with provider and pharmacist|
16110251|NCT02087059|Drug|Ruxolitinib|
16110252|NCT02087046|Device|ANS Totally Implantable Deep Brain Stimulation System|ANS Totally Implantable Deep Brain Stimulation System will be implanted in the VIM nucleus of the thalamus
16110253|NCT02087033|Dietary Supplement|ritmonutra|2 tablets a day by mouth for 4 weeks
16110254|NCT02087033|Dietary Supplement|placebo|sugar pill manufactured to simulated ritmonutra: 2 tablets a day for 4 weeks
16110255|NCT02087020|Procedure|Debridement, antibiotics and implant retention|DAIR treatment protocol embodies an extensive surgical debridement and a radical excision of infected tissue. This is followed by exchange of modular components (articulating surfaces of the implant such as the femoral head, acetabular liner in total hip arthroplasty and the tibial insert, the polyethylene meniscus, in total knee arthroplasty). The wound is then copiously irrigated (> 9 litre) with 0.9 % sodium chloride and then closed.
16110256|NCT02087007|Drug|Cilostazol|100mg oral tablets bid during 2 weeks after dosing of 50mg oral tablets bid during 2 weeks
16110257|NCT02087007|Drug|placebo|100mg oral placebo tablets bid during 2 weeks after dosing of 50mg oral placebo tablets bid during 2 weeks
16110258|NCT02086994|Drug|misoprostol|given after the delivery of the anterior shoulder of the baby.
16110259|NCT02086994|Drug|carbetocin|given after delivery of anterior shoulder
16110260|NCT02086968|Drug|Injectafer|2 doses of Injectafer, at 15mg/kg for a maximum single dose of 750mg given on days 0 and 7 for a total of up to 1500mg
16110261|NCT02086968|Drug|Ferrous Sulfate tablets|325mg (1 tablet) three times a day for 28 days
16110262|NCT02086955|Behavioral|Nursing counseling|The participants who are randomized in the intervention group receive standardized education regarding diabetic foot care. The nurse-led outpatient intervention lasts five weeks. During a period of five weeks, the participants are provided with weekly skill training, and counseling sessions on foot care. Each participant receives a foot care kit with essential foot care material and a foot care diary.
16110263|NCT02086942|Drug|Bortezomib|Induction therapy：1.6mg/m2 or 1.3mg/m2 SC,Days 1, 6, 11, 16 of each 28 day cycles,4 cycle Intensive therapy：1.6mg/m2 or 1.3mg/m2 SC,Days 1, 6, 11, 16 of each 28 day cycles,5 cycles.
16110264|NCT02086942|Drug|cyclophosphamide|Induction therapy：300mg/m2 VD Days 1-3 of each 28 day cycles,4 cycles. Intensive therapy：300mg/m2 VD Days 1-3 of each 28 day cycles,5 cycles. Maintenance treatment with CP: 200mg PO Days 1-14 of each 28 day cycles,12 cycles.
16110265|NCT02086942|Drug|Dexamethasone|Induction therapy：40 mg/d VD Days 1,6,11,16 of each 28 day cycles,4 cycles Intensive therapy：40 mg/d VD Days 1,6,11,16 of each 28 day cycles,5 cycles.
16110266|NCT02086929|Drug|Trazodone|
16110267|NCT02086929|Drug|Venlafaxine|
16110268|NCT02086903|Drug|Ticagrelor 90 mg|The subjects administer Ticagrelor 90 mg as loading dose (LD) follow by 90 mg/day as maintenance dose (MD) for 5 days, following a 2-week washout period, to receive the alternate thienopyridine (Clopidogrel 600 mg as LD follow by 75 mg/day as MD for 5 days).
16110269|NCT02086903|Drug|Clopidogrel 600 mg|The subjects administer Clopidogrel 600 as loading dose (LD) follow by 75 mg/day as maintenance dose (MD) for 5 days, following a 2-week washout period, to receive the alternate thienopyridine (Ticagrelor 90 mg/day as LD, follow by 90 mg/day as MD for 5 days).
16110270|NCT02086890|Device|Electro-acupuncture|
16110271|NCT02086890|Device|Laser Acupuncture|
16110272|NCT02086890|Device|Transcorneal Electrical Stimulation|
16110273|NCT02086890|Device|Sham Electro-acupuncture|
16110274|NCT02086890|Device|Sham laser acupuncture|
16110275|NCT02086890|Device|Sham transcorneal electrical stimulation|
16110276|NCT02086864|Drug|lactose/sucrose granule (Individualized homeopathic medicine treatment)|The homeopathic remedy (study medication) for each patient will be chosen from among the homeopathic medicines manufactured by Boiron Canada and currently approved for sale in Canada by Health Canada. As per classical homeopathy practice, once the most appropriate homeopathic remedy has been chosen, it will be prescribed by the homeopath according to her/his clinical judgment (maximum on a daily basis, 3 times per day, minimum 1 dose (or zero doses on the second consult or later)) with administration instructions given to the parent and patient as appropriate. Water dosing, in which a lactose/sucrose granule remedy is dissolved in 250 ml of water will be used based on the homeopath's clinical judgment. Only one remedy will be administered at a time.
16110277|NCT02086864|Drug|Placebo lactose/sucrose pill|
16110278|NCT02086864|Behavioral|Homeopathic consultation|
16110279|NCT02086851|Behavioral|Lifestyle Intervention|
16110280|NCT02086851|Behavioral|Parent Motivational Interviewing|
16110281|NCT02086838|Drug|Theragran Hematinic|
16110282|NCT02086838|Drug|low molecular weight iron dextran|
16110283|NCT02086825|Drug|Rifaximin|(Xifaxin®, Salix Pharmaceuticals) 550mg tablet twice daily.
16110284|NCT02086825|Drug|Lactulose|20g dose titrated
16110285|NCT02086799|Drug|IV thyroxin|Patients will receive treatment with intra-venous thyroxine 100mcg once on admission and additional 100mcg after 12 hours.
16110286|NCT02086799|Drug|Placebo|Patients will receive treatment with normal saline 100ml once on admission and additional 100ml after 12 hours
16110287|NCT02086786|Drug|Risperidone ISM|"Four doses of 75 mg of Risperidone ISM as intramuscular (IM) injection into the deltoid muscle at 28-day intervals.
~Four doses of 75 mg of Risperidone ISM as intramuscular injections into the gluteal muscle at 28-day intervals."
16110288|NCT02086773|Biological|Red blood cell transfusion|
16110289|NCT02086760|Other|Ultrasonography with oral hydration|Before, 30 min and 90 min following oral hydration
16110290|NCT02086760|Radiation|Scintigraphy|
16110291|NCT02086747|Drug|Acetaminophen|100 ml iv, 4 times a day for 72 hours
16110292|NCT02086747|Drug|Isotonic|100 ml iv, 4 times a day for 72 hours
16110293|NCT02086734|Other|Perfusion-CT|"Baseline Perfusion CT-Scan (before AAT)
~Follow-Up I Perfusion-CT Scan 7 days after start with AAT
~Follow-Up II Perfusion-CT Scan 8 weeks after start with AAT"
16110294|NCT02086721|Drug|L19-IL2|"Patients receive a schedule of 1 x 30 Gy, 3 x 15-20 Gy; 5 x 12 Gy; 8 x 7.5 Gy; to the 80 % or 100 % isodose.
~Step -1: Toxicity of 10 Mio IU of L19-IL2 (n=3-6)10 Mio IU of L19-IL2 (max. 6 cycles) via i.v. bolus injection.
~Toxicity scored at every i.v. drug administration and on day 7, 14 and 21. Step 1: Toxicity of 15 Mio IU of L19-IL2 (n=3-6)(max. 6 cycles) via i.v. bolus injection.
~Step 2: Toxicity of 22.5 Mio IU of L19-IL2 (n=3-6)(max. 6 cycles) via i.v. bolus injection.
~Toxicity scored at every i.v. drug administration and on day 7, 14 and 21 of the cycle.
~Step 3: Expansion cohort of the maximally tolerable dose (n=10) Administration of the maximally tolerable dose of L19-IL2(max. 6 cycles) via i.v. bolus injection.
~Toxicity scored at every i.v. drug administration and on day 7, 14 and 21 of the cycle."
16110295|NCT02086708|Device|Shear Wave sonoelastography|Shear Wave Sonoelastography as a ultrasound technique to measure liver fibrosis is performed on patients scheduled for non-focal liver biopsy. Results are compared with pathological score of fibrosis from liver biopsy.
16110296|NCT02086669|Procedure|Pneumatic dilatation|
16110297|NCT02086669|Procedure|Laparoscopic myotomy|
16110298|NCT02086656|Drug|capecitabine, oxaliplatin, irinotecan and bevacizumab|perioperative COI-B
16110299|NCT02086643|Procedure|Retroclavicular block|Retroclavicular ultrasound guided nerve block with total injection of 40 ml of a mixture of 20 ml ropivacaine 0,5% (5 mg/ml) + 20 ml mepivacaine 1,5% (15 mg/ml) + epinephrine 1 : 400 000 (2,5 mcg/ml). Incremental injections of 5 ml separated by an aspiration test.
16110300|NCT02086630|Behavioral|Heart to Heart|
16110301|NCT02086617|Other|ultrasound of aorta|
16110302|NCT02086604|Drug|Brentuximab vedotin|
16110303|NCT02086604|Drug|Lenalidomide|
16110304|NCT02086591|Drug|Doxycycline|
16110305|NCT02086578|Device|Breast MRI|
16110306|NCT02086578|Behavioral|Breast-Q© questionnaire|
16110307|NCT02086578|Radiation|Multi-Beam IMRT|The radiation dose (50-50.4 Gy/25-28 fractions in approximately 5-6 weeks), treatment-planning and delivery aspects are according to departmental guidelines for breast IMRT.
16110308|NCT02086565|Behavioral|Portal training and home visits|patient portal training and home visits by CHW to coordinate care
16110309|NCT02086565|Behavioral|Portal training|training in use of patient portal
16110310|NCT02086552|Other|Laboratory Biomarker Analysis|Correlative studies
16110311|NCT02086552|Drug|Lenalidomide|Given PO
16110312|NCT02086552|Drug|Sonidegib|Given PO
16110313|NCT02086539|Other|Large Envelope|
16110314|NCT02086539|Other|Priority Mail|
16110315|NCT02086539|Other|Amazon|
16110316|NCT02086526|Drug|Metformin|Approximately 37 patients will start metformin therapy 3 months after their visit 2. All other patients will receive metformin therapy at their visit 2.
16110317|NCT02086513|Drug|LDE225|Treatment with LDE225
16110318|NCT02086500|Drug|Tranexamic Acid|1 gram of prehospital Tranexamic Acid
16110319|NCT02086500|Other|Saline control|Saline Control
16110320|NCT02086487|Drug|Nilotinib 300 mg.|"Patients diagnosed with chronic myeloid leukemia receiving treatment of Imatinib 400 mg once a day but are determined to be sub-optimally responding to Imatinib therapy as per the ELN 2013 guidelines will be switched to Nilotinib 300 mg BID and then will be assessed for therapy response. ELN guidelines 2013 for imatinib therapy response states as:
~Minor cytogenetic response mCyR or minimal response at 3 months (Ph+ metaphases in BM 35 to 95 %); BCR-ABL1 transcript > 10% at 3 months; Partial cytogenetic response at 6 months Ph+ metaphases in BM 0to 35); BCR-ABL1 transcript is 1 to 10% at 6 months. Less than a major molecular response at > 12 months; i.e (BCR-ABL1 0.1 -1%)"
16110321|NCT02086474|Drug|Hyaluronan|Intra-articular injection
16110322|NCT02086474|Drug|Bupivacaine|Extra-capsular injection
16110323|NCT02086461|Device|Pneumatic pyloric dilatation|
16110324|NCT02086461|Other|15 mm pyloric balloon dilatation|
16110325|NCT02086448|Device|CPAP|CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevents apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
16110326|NCT02086448|Device|sham-CPAP|
16110327|NCT02086448|Other|Sleep hygiene|Information about sleep apnea and healthy sleep. Information about local sleep resources
16110328|NCT02086435|Procedure|Extracorporeal morcellation|"patients treated with protected removal by endobag and extracorporeal myoma morcellation with cold scissors and scalpel blade or with power morcellator used inside the bag itself"
16110329|NCT02086435|Procedure|Intracorporeal morcellation|patients treated with standard intracorporeal morcellation, using reusable electronic device
16110330|NCT02086422|Drug|ivabradine|
16110331|NCT02086422|Drug|Placebo|
16110332|NCT02086422|Other|Exercise|
16110333|NCT02086409|Dietary Supplement|Yogurt supplemented with vitamin D and calcium|The product is a yogurt containing 200 IU of vitamin D and 400 mg of calcium. Participants take 2 yogurts per day.
16110334|NCT02086409|Dietary Supplement|Yogurt not supplemented with vitamin D and calcium|The comparator is represented by a yogurt not supplemented with vitamin D and calcium.Participants take 2 yogurts per day.
16110335|NCT02086396|Dietary Supplement|pumpkin seed flour|The pumpkin seed flour group received 20g/day of pumpkin seed flour during 12 weeks
16110336|NCT02086396|Dietary Supplement|Placebo (cassava flavored flour)|The group placebo (cassava flour flavored) received 20g/day of cassava flour flavored during 12 weeks.
16110337|NCT02086370|Procedure|Standard PBS|the tube will be removed by coagulation and section of the tissue beginning from the very distal fimbrial and proceeding toward the uterine cornu. The resection will be performed at the level of the posterior tubal margin, sparing the mesosalpinx.
16110338|NCT02086370|Procedure|Radical PBS|the tube will be removed by coagulation and section of the tissue beginning from the very distal fimbrial and proceeding toward the uterine cornu. The resection will be performed at the level of ovarian margin and the uterus-ovarian ligament, including the mesosalpinx removal.
16110339|NCT02086357|Procedure|SWUE|
16110340|NCT02086344|Procedure|PBS|TLH plus PBS
16110341|NCT02086344|Procedure|TLH _adnexal preservation|TLH without PBS
16110342|NCT02086331|Procedure|Contrast enhanced ultrasound|Infusion of microbubbles to enhance blood vessels in the leg for ultrasound
16110343|NCT02086331|Behavioral|Treadmill test|Exposes you to exercise in a controlled environment. We will see if we can detect this change with our new ultrasound protocol
16110344|NCT02086331|Procedure|Contrast enhanced ultrasound|
16110345|NCT02086318|Other|OvAge assessment|Basal serum anti-Mullerian hormone (AMH), Follicle-stimulating hormone (FSH) and Estradiol (E2), antral follicle count (AFC), ovarian volume, Vascularization Index (VI), Flow Index (FI) and Vascularization Flow Index (VFI) will be measured in all women between day 1 and day 4 of menstrual cycle. Evaluation can be repeated after every kind of intervention regarding ovaries, both medical or surgical. Evaluation can be repeated also at interval of 3-6-12 months in order to study the modification of ovarian age when time passes.
16110346|NCT02086305|Behavioral|Transitional Care Model|Symptom assessment and management, care goal setting, post-discharge support
16110347|NCT02086305|Behavioral|Usual care|Usual care is the routine practice in the hospital
16110348|NCT02086292|Procedure|2 ml 1% Lidocaine|
16110349|NCT02086292|Procedure|1 ml 2% Lidocaine|
16110350|NCT02086279|Drug|GnRH analogue|"Patients with uterine myoma, endometriosis, fibromatous uterus, chronic pelvic pain in list for laparoscopic surgery or laparotomy are usually pharmacologically treated by administration of GnRHa, 11.25 mg at 21° day of the menstrual cycle and repeated after 3 months. This treatment is part of our preoperative routine in order to reduce pain symptoms, menstrual blood loss, uterine or fibroids vascularization and size, during the months spent on surgery waiting list.
~Patients who will satisfy inclusion and exclusion criteria will be enrolled in this study protocol and will be subjected to valuation of ovarian reserve: specifically, serum levels of AMH and antral follicle count (AFC) between first and fourth days of the menstrual cycle will be measured."
16110351|NCT02086266|Other|PILATES|
16110352|NCT02086266|Other|PFMT and AES|
16110353|NCT02086253|Drug|BQ-788 and/or BQ-123|
16110354|NCT02086240|Drug|XBD173|XBD173 (Emapunil is an anxiolytic drug which acts as a selective agonist at the peripheral benzodiazepine receptor), a drug which binds the TSPO with high affinity.
16110355|NCT02086227|Drug|Glucagon for Injection (Fresenius Kabi USA)|Test product: A 1 mg (1 IU/ml) Glucagon for Injection (Fresenius Kabi USA)
16110356|NCT02086227|Drug|Glucagon for Injection (Bedford Laboratories)|Reference product: B 1 mg (1 IU/ml) of GlucaGen® for Injection (Bedford Laboratories)
16110357|NCT02086214|Device|Proprioceptive pressure therapy|Proprioceptive pressure therapy using a a LYCRA® compressive sleeve initially used in burn therapy : 15 to 25 mmHg.
16110358|NCT02086214|Device|Control|LYCRA® non-compressive sleeve initially used in burn therapy : < 5 mmHg.
16110359|NCT02086201|Behavioral|Problem Solving Therapy|PST is a behavioral intervention for depression that is delivered by trained therapists over a 9 week period. It consists of a process to help patients understand and then solve the problems in their lives they feel is contributing to their depression.
16110360|NCT02086201|Behavioral|Engage|Engage is a weekly behavioral intervention that is delivered over a 9 week period of time by trained therapists. The focus of Engage is to help patient reconnect with activities that they have lost interest in pursuing due to depression.
16110361|NCT02086188|Drug|Mirabegron|see detailed information in associated Arm Description
16110362|NCT02086188|Drug|Placebo|Sugar pill manufactured to mimic Mirabegron 25mg tablet.
16110365|NCT02086162|Behavioral|Web-based motivational decision support system|
16110366|NCT02086162|Behavioral|NCI Education|
16110367|NCT02086149|Behavioral|Aerobic Exercise|12-week moderate-intensity behavioral exercise intervention. Weekly sessions with an exercise physiologist who will also assign weekly exercise goals. Two month course of the nicotine patch initiated during week 5.
16110368|NCT02086149|Behavioral|Health Education|12-week health education control. Weekly sessions about 12 different topics related to the health effects of smoking, led by an expert in smoking cessation.
16110369|NCT02086123|Procedure|Epidural Analgesia|Bupivacaine + Fentanyl
16110370|NCT02086123|Procedure|Parenteral Analgesia (Intravenous)|Dilaudid 0.2 -0.4 mg IV every 3 hours
16110371|NCT02086110|Dietary Supplement|Synbiotic|
16110372|NCT02086110|Dietary Supplement|Prebiotic|
16110373|NCT02086097|Drug|Dexketoprofen trometamol|25m of dexketoprofen (oral intake) every 8 hours
16110374|NCT02086097|Drug|Ibuprofen|600 mg of Ibuprofen (Oral Intake) every 8 hours
16110375|NCT02086097|Drug|PLACEBO|INACTIVE SUGAR PILLS
16110376|NCT02086084|Device|NIV|Standard care
16110377|NCT02086084|Device|ECCO2R|Application of ECCO2R in addition to NIV
16110378|NCT02086071|Procedure|re biopsy|re biopsy depending on the location of the pathology
16110379|NCT02086045|Device|DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System|percutaneous coronary
16110380|NCT02086032|Drug|1mg 17 beta-estradiol|Comparing sleeping quality between micronized progesterone and dydrogesterone users.
16110381|NCT02086032|Drug|Dydrogesterone|Comparing sleeping quality between micronised progesterone and dydrogesterone users.
16110382|NCT02086032|Drug|micronized progesterone|Comparing sleeping quality between micronised progesterone and dydrogesterone users
16110383|NCT02086019|Drug|Conservative Arm|crossover to angiogram only if predefined criteria met
16111441|NCT02077946|Drug|sitagliptin|No treatment given.
16110386|NCT02085980|Device|Laser treatment|The laser handpiece (probe) will be deposited in the vaginal canal and the laser energy will be delivered through the handpiece
16110387|NCT02085967|Drug|rifampin 600 mg|
16110388|NCT02085967|Drug|itraconazole 200 mg|
16110389|NCT02085967|Drug|midazolam 2 mg with bupropion 75 mg|
16110390|NCT02085967|Drug|E2006|
16110391|NCT02085941|Procedure|Cryoablation|Type and number (Mean 3, range 1-10) of cryoprobe(s) used depend on size and shape of target lesion
16110392|NCT02085941|Device|Biopsy|If target lesion has not been previously biopsied, a core biopsy may be taken prior to the cryoablation.
16110393|NCT02085928|Other|Intratissue percutaneous electrolysis, associated with eccentric exercise and stretching|"The EPI technique was performed under ultrasound-guidance on the clinically relevant area (or areas of maximum tenderness to palpation and with ultrasonographic degenerative tendon changes) using an intensity of 4-6 mA during 3 seconds, approximately 3 times. We used the EPI machine (Cesmar Electromedicina S.L., Barcelona, Spain) and a GE Logiq E Portable Ultrasound Machine with GE Linear probe 12L-RS (5-13 mhz) (GE Healthcare, Wisconsin, EEUU).
~The eccentric exercise program consisted of three series of up to 10 repetitions of eccentric work, repeated twice daily (morning and afternoon), under maximum load (initially with one kilogram) in an optimal and functional pain-free range.
~The stretching program consisted of a stretching exercise for the epicondylar muscles consisting in three series of 7 repetitions twice a day (morning and afternoon."
16110394|NCT02085915|Other|strip Peri Screen|
16110395|NCT02085902|Drug|Ropivacaine|
16110396|NCT02085889|Other|no intervention: observational study|observational
16110397|NCT02085876|Other|2 additional MRI sequences|
16110398|NCT02085876|Other|An additional blood sample|
16110399|NCT02085863|Drug|laquinimod|Oral laquinimod 0.6 mg capsules (with oral contraceptives tablets containing 30 μg ethinylestradiol and 150 μg levonorgestrel (Microgynon®)
16110400|NCT02085863|Drug|Placebo|Placebo (with oral contraceptives tablets containing 30 μg ethinylestradiol and 150 μg levonorgestrel (Microgynon®)
16110401|NCT02085837|Other|Education|Additional education will be provided by nurses to improve communication and reduce fragmentation of care.
16110402|NCT02085837|Other|Daily weight measurement and monitoring|Monitor weight to avoid problems related to hypervolemia.
16110403|NCT02085837|Other|Universal Dietary education|To improve diet and health
16110404|NCT02085837|Other|Medication review|Medication will be reviewed by nurses to detect any discrepancies to reduce medication error.
16110405|NCT02085837|Other|Focused advanced directive program|Education will be provided to increase awareness and encourage patients to have advanced directive.
16110406|NCT02085837|Other|Countdown to fistula program|To reduce the number of patients starting dialysis with catheter in place, comprehensive stepwise intervention will be provided by nurses to ensure arterio-venous (AV) fistula placement in all appropriate patients, with coordinated follow up and failure recovery processes.
16110407|NCT02085824|Drug|Enoxaparin|
16110408|NCT02085824|Drug|rivaroxaban|
16110409|NCT02085824|Drug|dabigatran|
16110410|NCT02085811|Other|radiography standard|
16110411|NCT02085798|Other|Either Wait and See, or Supportive Treatment, or Active Treatment at physician discretion|As described above
16110412|NCT02085785|Behavioral|Coached group|Participants randomized to the coached arm will receive 1) education and self-monitoring materials [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], 2) a home visit by an exercise specialist, and 3) 11 telephone calls (over a 20-week period) by a health coach who will utilize motivational interviewing techniques to help the participant set eating and activity goals and trouble shoot problems when they occur
16110413|NCT02085785|Behavioral|Self-directed control group|Participants randomized to the self-directed control arm will receive the same educational and self-monitoring materials as the coached group [e.g., a booklet, calorie count book, pedometer, and scale (if they do not have one)], but no home visit and no coaching calls. They will be encouraged to make behavior changes on their own.
16110414|NCT02085785|Other|Screened only|Screened only - No intervention -- individuals who are contacted and/or screened for eligibility
16110415|NCT02085772|Other|Blood samples at 37-38 Weeks of amenorrhea|
16110416|NCT02085772|Other|Blood samples at 41 Weeks of amenorrhea if prolonged pregnancy|
16110417|NCT02085746|Other|Defining Sexual Activity Questionnaire|
16110418|NCT02085720|Device|CPAP therapy|As OSA may increase the risk of cardiovascular mortality, all elderly subjects with AHI ≥ 15 or those with AHI ≥ 5 plus either cardiovascular risk factors or ESS score ≥ 10 received patient education program. Elderly subjects who agree for home CPAP treatment were prescribed nasal CPAP units with time clocks to assess objective compliance (run time). ESS, sleep apnea specific quality of life index (SAQLI), and cognitive function tests were performed at baseline, 3 months, 6 months and 12 months after CPAP treatment.
16110419|NCT02085707|Procedure|Total hip replacement arthroplasty|treatment with total hip replacement arthroplasty with the implant chosen by the institution
16110420|NCT02085707|Procedure|Closed reduction and internal fixation|treatment with closed reduction and internal fixation with 2 cannulated hip pins
16110421|NCT02085694|Drug|Lactobacillus brevis CD2|
16110422|NCT02085681|Other|Tele-medicine|Patients at the diabetes clinics will be subjected to non-mydriatic retinal imaging and the images will be transferred to the eye hospital via internet using a specified software - Aravind Diabetic Retinopathy Evaluation Software (ADRES) that enables a retinal specialist to read and grad the image and send the feedback immediately to the diabetes clinic. Based on the presence or absence of DR the patients will be referred to the eye hospital for detailed retinal examination.
16110423|NCT02085681|Other|Conventional referral|All eligible patients in the conventional arm will be counselled on the importance of eye screening and will be referred to the eye hospital
16110424|NCT02085668|Device|Renal denervation (Symplicity™)|Delivery of radiofrequency through the wall of the renal artery to disrupt the surrounding renal nerves under angiography control
16110425|NCT02085655|Drug|pegaspargase|pegaspargase: 2000U/m2 im on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
16110426|NCT02085655|Drug|Gemcitabine|1000mg/m2, ivd on day 1 and 8 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
16112295|NCT02071472|Other|DP medication reconciliation|
16110427|NCT02085655|Drug|Oxaliplatin|100mg/m2 ivd on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops
16110428|NCT02085655|Drug|Methotrexate|3000m g/m2 civ 6-hour on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
16110429|NCT02085655|Drug|Dexamethasone|40mg ivd on day 1 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
16110430|NCT02085655|Drug|Thalidomide|100-200mg, PO, after chemotherapy
16110431|NCT02085642|Other|Acupuncture|Single disposal needle to be used, 0.02 mm x 25 mm in length
16110432|NCT02085642|Other|Sham needle|Retractable needle with no skin puncture
16110433|NCT02085629|Biological|Donor M reg (Mreg_UKR)|"Experimental: M reg treatment
~Donor M reg (2.5-7.5 million cells/kg) IV infused (6-7d before Tx) into recipients of a living donor renal Tx. Recipients also receive prednisolone, mycophenolate mofetil and tacrolimus background immunosuppression (as described in detail in the arm description)."
16110434|NCT02085616|Behavioral|Proactive service|In the proactive service the callers to the quitline are offered a number of callbacks.
16110435|NCT02085616|Behavioral|Reactive service|In the reactive service the callers to the quitline are informed that they can themselves call back whenever they like.
16110436|NCT02085603|Drug|Saracatinib|
16110437|NCT02085603|Drug|Placebo|
16110438|NCT02085590|Biological|BCG vaccine|
16110439|NCT02085590|Biological|Lipopolysaccharide (LPS) E. Coli 1 ng/kg intravenously|
16110440|NCT02085577|Drug|(S)-(+)-Ketamine Hydrochloride Solution 25 mg/ml|Ketamine (25 mg/ml) bolus 0.5 mg/kg administered immediately after induction of anesthesia, followed by infusion ketamine 0,25 mg/kg/hour that is terminated when the last suture to the skin has been performed.
16110441|NCT02085577|Drug|Isotonic sodium chloride 0.9 percent|Isotonic sodium chloride 0.9 percent 0.02 ml/kg administered immediately after induction of anesthesia, followed by infusion isotonic sodium chloride 0.01 ml/kg/hour that is terminated when the last suture to the skin has been performed.
16110442|NCT02085577|Drug|Paracetamol 1 g|Paracetamol 1 g orally 1 hour preoperatively and every 6 hours after extubation time during the first 24 hours.
16110443|NCT02085577|Drug|Morphine Sulphate 1 mg/ml|Morphine Sulphate 1 mg/ml administered as patient-controlled analgesia (PCA, bolus 2.5 mg, lockout 5 minutes) 0-24 hours postoperatively
16110444|NCT02085577|Drug|Morphine Sulphate 1 mg/ml|Morphine Sulphate 1 mg/ml, bolus 2.5 mg administered by the PACU nurse on request of the patient for the first hour postoperatively.
16110445|NCT02085577|Drug|Ondansetron 2 mg/ml|Ondansetron 2 mg/ml 4 mg iv in case of moderate to severe nausea, supplemented by Ondansetron 1 mg iv if needed
16110446|NCT02085577|Drug|Usual daily opioids|The patients usual daily opioid consumption are administered during the study period
16110447|NCT02085577|Drug|Morphine Sulphate 1 mg/ml|Morphine Sulphate 1 mg/ml, bolus 0.4 mg/kg administered 45 minutes before expected awakening.
16110448|NCT02085577|Drug|Sufentanil 5 microgram/ml|Sufentanil 5 microgram/ml, bolus 5 micrograms administered by the anaesthetic nurse in the operating room if the patient is in pain upon awakening.
16110449|NCT02085564|Procedure|Peritoneal washing cytology|The methode is describes in the detailed study description
16110450|NCT02085551|Device|Mechanical Thrombectomy by the Indigo System|
16110451|NCT02085538|Drug|palbociclib|palbociclib 125 mg oral capsule with food once
16110452|NCT02085538|Drug|palbociclib|palbociclib 125 mg oral capsule with food once
16110453|NCT02085538|Drug|palbociclib|palbociclib 125 mg oral capsule with food once
16110454|NCT02085538|Drug|palbociclib|palbociclib 125 mg oral capsule with food once
16110455|NCT02085525|Other|Nurse Practitioner Clinic|"The nurse practitioner (NP) clinic is staffed by two NPs, one registered nurse, and several medical assistants. Patients can be seen by either NP during their treatment course. Patients will be scheduled to be seen in the (NP) clinic based on randomization assignment.
~Each clinic visit focuses on specific concerns and toxicities of the patient and their significant other. This will include physical as well as psychological, social and spiritual needs."
16110456|NCT02085512|Procedure|Neurocognitive retraining Web Based Intervention|"Neurobehavioral training will be delivered through the web, with prompting for training tasks accomplished through daily emails that include a single integrated log-in system using a customized implementation with OneLogin. All training tasks have game-like features making them visually engaging, and motivating. The training tasks provide immediate feedback about performance, and are specifically designed to target circuitry critical for executive functioning (EF) and emotional reactivity."
16110457|NCT02085512|Other|Control, web-based tasks|No training modules
16110458|NCT02085499|Other|non-synchronized NIMV|"During the study each infant will undergo a 2-hour period of NIMV at a frequency of 30 cycles per minute.
~NIMV will be provided by a time cycled, pressure limited neonatal ventilator (Puritan Bennett 840, Covidien, Boulder, CO)."
16110459|NCT02085499|Other|Synchronized NIMV|"During the study each infant will undergo a 2-hour period of S-NIMV at a frequency of 30 cycles per minute.
~S-NIMV will be provided by a time cycled, pressure limited neonatal ventilator, with leak compensation capacity and nasal flow triggered ventilation (Puritan Bennett 840, Covidien, Boulder, CO). Synchronization will be achieved by the leak compensation software and the internal sensor of the ventilator."
16110460|NCT02085486|Device|Ultrasound-assisted puncture|Portable ultrasound device
16110461|NCT02085486|Other|Standard|Standard inspection, palpation.
16110462|NCT02085473|Biological|Tralokinumab 300 mg|Participants will receive 300 milligram (mg) tralokinumab when delivered as a 2 milliliter (mL) subcutaneous injection at different flow rates.
16110466|NCT02085447|Behavioral|CAE-L|Eight sessions of the manualized intervention, Customized Adherence Enhancement (CAE), will be delivered along with a long-acting injectable antipsychotic (either haloperidol decanoate or paliperidone palmitate dosed per package insert) over the course of six weeks. Study staff will also communicate with the participant's mental health provider to help ensure treatment continuation after study end.
16110567|NCT02084706|Procedure|Triamcinolone (20 g) Injection over the A1 pulley.|
16110572|NCT02084641|Other|Over feeding|Study participants will be given low saturated fat snacks, an additional 750-1000 calories to gain 6-8 lbs over 4 weeks
16110467|NCT02085434|Behavioral|FITLINE practice-based referral program|The FITLINE practice-based referral program provides pediatric practices an easily accessible resource to help families make AAP-recommended Stage 1 lifestyle changes. The program includes a pediatric practice-based component (systems to identify overweight and obese children ages 8-12, a brief pediatric provider-delivered intervention, referral to the FITLINE counseling program, and feedback from the FITLINE nutritionist) and a parent support component(eight weekly FITLINE counseling telephone calls delivered by centrally located nutritionists). Providers receive a summary from the nutritionist of the progress made by families so they may support maintenance of an improved lifestyle, or refer for additional intervention.
16110468|NCT02085421|Device|tDCS|Transcranial direct current stimulation (tDCS) is a form of non-invasive neuromodulation that has been shown to enhance learning. tDCS is applied with current intensity of 1-2 mA of direct current and can be applied both before and during each cognitive remediation treatment session. Two saline soaked electrode sponges will be applied to the scalp.
16110469|NCT02085408|Drug|clofarabine|Given IV
16110470|NCT02085408|Drug|daunorubicin hydrochloride|Given IV
16110471|NCT02085408|Other|clinical observation|Undergo clinical observation
16110472|NCT02085408|Drug|cytarabine|Given IV
16110473|NCT02085408|Drug|decitabine|Given IV
16110474|NCT02085408|Other|laboratory biomarker analysis|Correlative studies
16110475|NCT02085408|Procedure|quality-of-life assessment|Ancillary studies
16110476|NCT02085408|Other|questionnaire administration|Ancillary studies
16110477|NCT02085395|Drug|SR-T100 ® Gel|
16110478|NCT02085382|Procedure|Kangaroo Mother Care|"The infants were placed on continuous skin to skin contact between the mother and the baby as soon as possible. The mother kept her newborn infant between the breast, in close contact with her body and covered with the kangaroo tube. Infants wore diaper and a cap during the procedure. Breastfeeding was the standard feeding method.
~When the baby was not in KMC, the baby was placed in the bassinet under warm lamp, if needed, adequately clothed and covered."
16110479|NCT02085382|Procedure|Conventional Mother Care|"This is generally included: an artificial warming system (heated room overhead lamp warmers). Breastfeeding was also the standard feeding method but if indicated, babies can also be fed through tube or cup feeding. The mothers were allowed to visit their babies anytime but skin to skin contact was not allowed.
~Babies in both groups were monitored hourly. Their heart rate, respiratory rate and temperature were monitored and recorded. Any untoward events like hypothermia, hypoglycemia, apnea, signs of sepsis, and feeding problems were also noted."
16110480|NCT02085356|Behavioral|Protect your family|"Protect Your Family intervention is a manualized, closed, structured behavioral risk reduction program targeting HIV, stigma, disclosure, communication, intimate partner violence (IPV), PMTCT knowledge, safer conception, family planning and dual method sexual barrier use.
~Intervention participants will attend 3 prenatal weekly 2 hour gender-specific (male or female, 5-7 participants) group sessions followed by 1 individual counseling session and 2 monthly couples or individual (women-only) counseling sessions (1 prenatal, 2 postpartum) led by study-trained clinic staff (e.g., nurses, HIV counseling and testing (HCT) counselors) plus standard of care (PMTCT)"
16110481|NCT02085343|Behavioral|EXP|Participants will receive one-session exposure therapy consisting of six-6 minute trials of exposure to heights, involving ascending a 9-landing flight of outdoor stairs. Participants will be asked to ascend, accompanied by the therapist who will provide verbal encouragement throughout supporting efforts at exposure. An instructional set will be provided prior to treatment presenting the rationale for exposure as an effective means of reducing pathological fear.
16110482|NCT02085343|Behavioral|EXP + SBF|Participants will receive one-session exposure therapy consisting of six-6 minute trials of exposure to heights, involving ascending a 9-landing flight of outdoor stairs. Participants will be asked to ascend, accompanied by the therapist who will provide verbal encouragement supporting efforts at exposure. An instructional set will be provided prior to treatment explaining how safety behaviors serve to maintain fear, and how their elimination may enhance fear reduction. Additionally, the therapist will identify safety behaviors and prompt participants to reduce their utilization of them during treatment.
16110483|NCT02085343|Behavioral|EXP + SBF + AA|Participants will receive one-session exposure therapy consisting of six-6 minute trials of exposure to heights, involving ascending a 9-landing flight of outdoor stairs. Participants will be asked to ascend, accompanied by the therapist who will provide verbal encouragement supporting efforts at exposure. An instructional set will be provided explaining the rationale for eliminating safety behaviors, and how engagement in anti-phobic actions may enhance fear reduction. Additionally, the therapist will identify safety behaviors and prompt participants to reduce their utilization of them during treatment, and will instruct participants to enact a series of progressively challenging anti-phobic actions which oppose the prototypical fear response.
16110484|NCT02085330|Device|Hyperbaric oxygen therapy|100%, 2 ATA, 90 minutes
16110485|NCT02085317|Drug|acetylcholine Iontophoresis|Using a protocol similar to the one developed by Rossi and co-workers (Rossi et al., 2008), ACh (Acetylcholine - Sigma-Aldrich, St. Louis, USA) was delivered by 9 iontophoretic pulses of 0.1 mA for 20 s with 60 s interval between pulses using a drug delivery electrode filled with 0.1 ml of 1% ACh solution, attached to the dorsal aspect of the second left finger by a double-sided adhesive disc.
16110486|NCT02085317|Drug|sodium nitroprusside Iontophoresis|After Ach, SNP (Nipride® 10mg/ml - Biolab, São Paulo, Brazil) was delivered by 7 iontophoretic pulses of 0.2 mA for 20 s with 180 s interval between pulses using another drug delivery electrode filled with 0.1 ml of 1% SNP solution, attached to the dorsal aspect of the third left finger. In both situations, an indifferent electrode was attached on the dorsal aspect of the left hand. Endothelial-dependent and independent skin vasodilator response to each iontophoresis pulse was measured in PUs, as mean value during each interval from one pulse to the following one.
16110487|NCT02085304|Procedure|Gross total resection and Gliadel(R) wafers implanted|Complete removal of tumor and implant of Gliadel(R) wafers that are small, dime-sized wafers designed to deliver the chemo drug, carmustine, directly into the cavity made when the brain tumor was removed.
16110488|NCT02085304|Radiation|GammaKnife(R) stereotactic Radiosurgery|GammaKnife® (GK) radiosurgery dose of 15 Gy in one fraction to the resection cavity margin
16110489|NCT02085304|Radiation|Standard fractionated radiation therapy|standard fractionated RT of 60 Gy in 30 fractions (over approximately six weeks)
16110649|NCT02084082|Drug|Linagliptin/Metformin ER FDC|1x Linagliptin/Metformin FDC tablet
16110650|NCT02084082|Drug|Linagliptin|1x Linagliptin tablet
16110490|NCT02085304|Drug|Temozolomide|temozolomide 75 mg/m2 daily for 42 days, will be administered to all patients beginning within 24 hours of GK/RT initiation as is routine clinical care. There will be a one month drug holiday following the 42 days before adjuvant chemotherapy begins. Adjuvant temozolomide administered 5 days monthly at 150-200 mg/m2/day will be administered for 12 months as is routine clinical care.
16110491|NCT02085291|Drug|Norepinephrine|Norepinephrine infusion to titrate MAP to usual level
16110492|NCT02085291|Drug|Crystalloid|Patients received 500 ml crystalloid for fluid challenge within 20 minutes, then a PLR test was performed to predict fluid responsiveness. If the patient was fluid responsive, more 500 ml crystalloids were given until fluid nonresponsive. If the MAP still not achieved the target value, NE was increased to achieve the target one.
16110493|NCT02085278|Device|Apollo Micro Catheter device|Detachable Tip Micro catheter
16110494|NCT02085265|Drug|Perindopril|Perindopril 2 mg, 4 mg or 8 mg/day (depending on kidney function and tolerability)
16110495|NCT02085265|Drug|Telmisartan|Telmisartan 40 mg or 80 mg/day (depending on age and tolerability)
16110496|NCT02085252|Drug|Leuprorelin|Solution for injection
16110497|NCT02085252|Drug|Bicalutamide|Bicalutamide tablets
16110498|NCT02085239|Drug|Lidocaine Ropivacaine|"8-10 ml of Lidocaine given by subcutaneous injection
~8-10 ml of Ropivacaine given by subcutaneous injection"
16110499|NCT02085239|Drug|Lidocaine alone|
16110500|NCT02085226|Other|Creative Engagement Intervention|"The CEI has 5 component stages which map the participant's journey with the Artist
~Meeting with Artist, discuss interests, stroke and explore initial creative goals.
~Introduction to materials and mark making to create interpretations of established images.
~From mark making and interpretations to developing personal project ideas.
~Turning personal project ideas into creative finished pieces.
~Review of completed work, mounting and display of work, future plans.
~It is recognised that participants will progress differently. Components may be repeated or retuned to or may be addressed simultaneously. Participants may progress rapidly and so move from stage 5 back to stages 2, 3 or 4 to progress new work or experience new materials or processes."
16110501|NCT02085226|Other|Portfolio Group|The Portfolio group will receive conventional rehabilitation activity at each site. In addition, to control for effects of art related attention received by the intervention group, after baseline assessment and randomisation, this group will receive from the research assistant, a portfolio of work produced by previous participants of the Tayside CEI, with details of community programmes that people with stroke can attend after hospital discharge. Participants will be invited to view the portfolio during their stay. Prior to outcome assessment, the research assistant will visit participants again to answer questions and to discuss options for community programmes, if the person is interested.
16110502|NCT02085213|Drug|Glyceryl Trinitrate|
16110503|NCT02085213|Drug|Matched Placebo|Matched placebo
16110504|NCT02085200|Other|horizontal adduction stretch with scapular stabilization|Scapular is stabilized during manual horizontal adduction stretch
16110505|NCT02085200|Other|Horizontal adduction stretch without scapular stabilization|Scapula stabilization is not performed during horizontal adduction stretch
16110506|NCT02085187|Other|Telemedicine training and counselling|"Training and counselling by the physiotherapist consisted of 3 weekly sessions, lasting 30-45 minutes, over a 3 week period, i.e. a total of 9 supervised sessions. Heart rate and oxygen saturation were monitored during the exercise training. This included thoracic mobilization exercises, cardio training, strength training and breathing exercises. The training intensity was progressed continuously.
~There were 1-2 sessions with the occupational therapist, which consisted of training and counselling on energy conservation techniques. The first session was 60 minutes long and included assessment, counselling and training. This session was delivered in the second week of the intervention. The intervention concluded in the third week, with sessions of 30 minutes as required."
16110507|NCT02085161|Drug|placebo to tiotropium + olodaterol|comparator
16110508|NCT02085161|Drug|tiotropium+olodaterol|tiotropium 5 mcg once daily
16110509|NCT02085161|Drug|tiotropium +olodaterol|olodaterol 5 mcg once daily fixed dose combination
16110510|NCT02085161|Drug|tiotropium|tiotropium 5 mcg once daily fixed dose combination
16110511|NCT02085148|Drug|Regorafenib (BAY73-4506)|Regorafenib will be given orally once a day, across cycles of 21 days each. During each cycle regorafenib is taken for 2 weeks followed by one week off the drug. Doses of the study drug used in this study are age-dependent and the children's dose will been adjusted based on the age and the body surface area and given either as tablets or granulate.
16110512|NCT02085148|Drug|Vincristine (Cellcristin®)|Vincristine will be given at a dose of 1.5 mg/m2 (0.05 mg/kg for subjects ≤ 10 kg, maximum 2.0 mg) on Day 1 and Day 8 in 21-day cycles.
16110513|NCT02085148|Drug|Irinotecan (Irinotecan Cell pharm®)|Irinotecan will be administered at a starting dose of 50 mg/m2/day from Day 1 to Day 5, in 21 day cycles.
16110514|NCT02085135|Drug|ALKS 5461|Sublingual tablet taken once daily
16110515|NCT02085122|Other|noninvasive ventilation|Ventilatory support with bilevel positive pressure was held for 30 minutes with the volunteer sitting comfortably. A fan with two pressure levels (Vivo 40 Bi-Level, General Electric Company), which was attached to the face of the individual through a face Macara ( Respironics), was initially adopted one of 15 cmH2O IPAP and EPAP was used 5 cmH2O, making admissible pressure of 10 cm H2O, where the IPAP would be increased, subject to the comfort of the patient until the patient reached a tidal volume of 6-8 ml / kg, not exceeding the maximum of 20 cmH2O for IPAP.
16110516|NCT02085109|Dietary Supplement|Fat milkshake|
16110517|NCT02085109|Dietary Supplement|Theobromine|
16110518|NCT02085096|Behavioral|Problem-Solving Therapy|Problem-solving therapy programs have been shown to be effective among parents of children diagnosed with cancer. Efforts have been made to apply this same strategy to spouses/significant others of men diagnosed with prostate cancer. The purpose of this study is to test the efficacy of problem-solving therapy on the spouses of prostate cancer patients.
16110568|NCT02084693|Device|COMPREHENSIVE|Comprehensive® Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.
16110569|NCT02084680|Behavioral|community health workers|community health workers offering individual prenatal education to pregnant women
16110570|NCT02084654|Drug|Exenatide 5 and 10 mcg 2 times a day|
16110571|NCT02084654|Drug|placebo|
16110519|NCT02085083|Behavioral|Telephone and email correspondence with an Inflammatory Bowel Disease Nurse|"The IBD pediatric-adult transition nurse will send an email each month containing:
~Brief Questionnaire: A link to a secured website will be provided where participants will respond to a questionnaire.
~Direct Nurse Contact: Telephone and email correspondence with an Inflammatory Bowel Disease Nurse
~Educational module: Every other month, we will include in the email another link to an optional educational module that will be part of a curriculum to facilitate transition readiness.
~MyHealth Passport
~Study Questionnaire: A personalized link to a more comprehensive study questionnaire similar to the baseline questionnaire will be emailed in the 6th and 12th (final) email."
16110520|NCT02085083|Behavioral|Minimal Intervention Arm|Patients randomized to the control group will have receive email based questionnaires and information relating to the MyHealth Passport application. This intervention is not expected to significantly improve outcomes.
16110521|NCT02085070|Drug|MK-3475|IV MK-3475
16110522|NCT02085057|Procedure|Functional Magnetic Resonance Imaging|
16110523|NCT02085044|Dietary Supplement|Ready-to-Used Supplement Food administration|
16110524|NCT02085031|Procedure|Intracorporeal Roux-en-Y esophagojejunostomy|During totally laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy intracorporeally using a transorally inserted anvil (OrVil™) will be performed.
16110525|NCT02085031|Procedure|Extracorporeal Roux-en-Y esophagojejunostomy|During laparoscopic total gastrectomy, Roux-en-Y esophagojejunostomy extracorporeally using a transabdominally inserted anvil will be performed.
16110526|NCT02085018|Drug|Omeprazole|Drug
16110527|NCT02085018|Drug|Matched placebo|Matched placebo
16110528|NCT02085005|Drug|Capecitabine|Pharmaceutical form:tablet Route of administration: oral
16110529|NCT02085005|Drug|Aflibercept AVE0005|Pharmaceutical form:concentrate for infusion Route of administration: intravenous
16110530|NCT02085005|Drug|Oxaliplatin SR96669|Pharmaceutical form:solution for infusion Route of administration: intravenous
16110531|NCT02084992|Other|Expanded technology disease management|Tablet computers loaded with a web-based disease management program will be given to patients for the duration of the study.
16110532|NCT02084992|Other|Telephonic disease management|
16110533|NCT02084979|Behavioral|telepsychiatry evaluation|telepsychiatry evaluation and consultation to primary care
16110534|NCT02084966|Procedure|Procedure/Surgery: Transplantation: OCT of Kidney Transplant|Device: Optical Coherence Tomography of Kidney Transplant
16110535|NCT02084953|Drug|BMS-791325|
16110536|NCT02084953|Drug|Moxifloxacin|
16110537|NCT02084953|Drug|Placebo matching BMS-791325|
16110538|NCT02084940|Drug|GnRH antagonist depot Degarelix|Women receive 20 mg of Degarelix on the first day of menstrual cycle followed by a fixed dose of 225 IU of recombinant FSH on the second day until the day of ovulation triggering
16110539|NCT02084927|Biological|HBOT|HBOT of 2 ATA for 90 minutes, for 60 treatments
16110540|NCT02084914|Procedure|Endometrial scratching|Group A: pipelle Group B: sound
16110541|NCT02084901|Device|Drug-eluting biodegradable stent Orsiro implantation|Drug-eluting biodegradable stent Orsiro implantation
16110542|NCT02084901|Device|Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation|Drug-eluting biodegradable stent BioMatrix or BioMatrix Flex implantation
16110543|NCT02084875|Drug|tofacitinib modified-release (MR) formulation|A single dose of tofacitinib modified release 11 mg tablet after receiving the standard FDA high fat/high calorie meal.
16110544|NCT02084875|Drug|tofacitinib modified-release (MR) formulation|tofacitinib modified release (MR) 11 mg tablet after a 10 hour overnight fast.
16110545|NCT02084862|Device|Ultrasound guided percutaneous tracheostomy|Ultrasound guided percutaneous tracheostomy
16110546|NCT02084862|Device|Bronchoscopy guided percutaneous tracheostomy|Bronchoscopy guided percutaneous tracheostomy
16110547|NCT02084836|Other|Functional Magnetic Resonance Imaging|
16110548|NCT02084823|Biological|cancer stem cell vaccine|
16110549|NCT02084810|Drug|activated recombinant human factor VII|"All subjects will receive one i.v. (intravenous, into the vein) injection of 90μg/kg.
~Each subject will be allocated to two treatment periods separated by a wash-out period of a week."
16110550|NCT02084810|Drug|eptacog alfa (activated)|All subjects will receive one i.v. injection of 90μg/kg. Each subject will be allocated to two treatment periods separated by a wash-out period of a week.
16110551|NCT02084797|Drug|V2R (Vasopressin 2 receptor)|All ten subjects were used as their own controls in this double-blind, randomized controlled trial assessing the effect of the V2R on sweat sodium concentration via use of a V2R blocker (antagonist), stimulator (agonist), against a placebo (drug naive state).
16110552|NCT02084784|Drug|Indocyanine green|Subcutaneous injection around the areola with 2-4 points Indocyanine green with 1ml of 0.5%
16110553|NCT02084784|Drug|methylene blue|Subcutaneous injection around the areola with 2-4 points Methylene blue with 1ml of 1%
16110554|NCT02084771|Drug|Intravenous Saline|Patients randomized to this arm will receive intravenous isotonic (0.9%) saline. The rate of isotonic saline will be 3 mL/kg given the one hour before CT and 1 mL/kg/hour for 6 hours post-CT as per Canadian guidelines. Patients weighing more than 110 kg will receive the rate as per a 110 kg patient. The dose will be rounded up to the nearest 5 mL.
16110555|NCT02084771|Biological|Oral Salt and Water|Oral salt capsules and water, based on patient weight
16110556|NCT02084758|Dietary Supplement|Nitrate supplementation|7 days of supplementation with sodium nitrate solution
16110557|NCT02084758|Dietary Supplement|Placebo supplementation|7 days of supplementation with sodium chloride solution
16110558|NCT02084745|Procedure|Boston keratoprosthesis type 1|The Boston KPro, purchased from Massachusetts Eye and Ear infirmary (Boston, MA), is implanted using the usual standard technique.
16110559|NCT02084745|Procedure|Glaucoma drainage device|The GDD that will be used is the Ahmed implant (New World Medical, Rancho Cucamonga, CA). The Ahmed implant will be implanted using the standard technique either at the time of KPro surgery in group 1, or 6 months following KPro in group 2.
16110560|NCT02084732|Drug|Sorafenib|drug
16110561|NCT02084719|Device|Oraquick HCV Rapid Antibody Test|
16110562|NCT02084719|Device|Standard algorithm|
16110563|NCT02084706|Procedure|Triamcinolone (20 g) and 2% Lidocaine injection over the A1 pulley|
16110564|NCT02084706|Drug|2% Lidocaine|
16110565|NCT02084706|Drug|Triamcinolone (20 g)|
16110573|NCT02084628|Drug|Gadoxetate disodium (Eovist/Primovist, BAY86-4873)|Participants to receive single dose of Eovist/Primovist as a manual injection at a dose of 0.1 milliliter per kilogram (mL/kg) body weight (BW) (0.025 millimole [mmol]/kg BW), followed by a flush of at least 5 mL saline (sodium chloride 0.9 percent [%] solution) manually.
16110574|NCT02084615|Drug|Aspirin|Subjects will undergo open inguinal hernia repairs while taking their normal dose of 81mg, 325mg, or no aspirin
16110575|NCT02084602|Drug|Artesunate|Orally administration of artesunate 4mg/Kg by three days
16110576|NCT02084602|Drug|Mefloquine|Orally administration of mefloquine 15mg/Kg in the fourth day Orally administration of mefloquine 10mg/Kg in the fifth day
16110577|NCT02084589|Other|PCEA with basal infusion and demand dose using ropivacaine 0,15% and fentanyl 2μg/ml for pain relief in labor|
16110578|NCT02084589|Other|PCEA without basal infusion (demand only) using ropivacaine 0,15% and fentanyl 2μg/ml for pain relief in labor|
16110579|NCT02084576|Drug|Nepafenac|One drop in the study eye 3 times daily for 30 days
16110580|NCT02084576|Drug|Ketorolac|One drop in the study eye 4 times daily for 30 days
16110581|NCT02084563|Drug|Induction Chemotherapy|"Induction chemotherapy for patients with AML eligible for intensive chemotherapy:
~Cytarabine 200 mg/m2 IV continuous infusion days 1-7
~Daunorubicin 90 mg/m2 intravenous piggyback days 1-3"
16110582|NCT02084563|Drug|Consolidation Chemotherapy|"Consolidation chemotherapy for patients eligible for intensive chemotherapy with low-risk AML or patients with intermediate-/high-risk AML who do not have matched donors:
~-Cytarabine 1.5 g/m2 IV in 3 hours days 1, 3 and 5 for 3 cycles"
16110583|NCT02084563|Drug|Autologous Stem Cell Transplantation|"Autologous Stem Cell Transplantation for consolidation of patients eligible for intensive chemotherapy with low-risk AML or patients with intermediate-/high-risk AML who do not have matched donors:
~Busulfan 1 mg/Kg PO q6h or 130 mg/m2 IV once daily days -7 to -4
~Cyclophosphamide 60 mg/Kg IV once daily days -3 and -2"
16110584|NCT02084563|Drug|Allogeneic Stem Cell Transplantation|"Allogeneic Stem Cell Transplantation for consolidation of patients eligible for intensive chemotherapy with intermediate-/high-risk AML
~Conditioning regimen:
~Busulfan 1 mg/Kg PO q6h or 130 mg/m2 IV once daily days -7 to -4
~Cyclophosphamide 60 mg/Kg IV once daily days -3 and -2 or Fludarabine 40 mg/m2 IV once daily days -7 to -4"
16110585|NCT02084563|Drug|Low Dose Cytarabine|"Chemotherapy for patients with AML who are not fit for intensive chemotherapy:
~Cytarabine 60 mg/m2 subcutaneous (SQ) bid days 1-5 (until CR or maximum 4 cycles)
~Cytarabine 40 mg/m2 SQ bid days 1-5 (after CR, until a maximum of 3 years of therapy or relapse, whichever comes first)"
16110586|NCT02084563|Drug|Decitabine|"Chemotherapy for patients with AML who are not fit for intensive chemotherapy:
~Decitabine 20 mg/m2 IV once daily days 1-10 (until CR or maximum 4 cycles)
~Decitabine 20 mg/m2 IV once daily days 1-5 (after CR, until a maximum of 3 years of therapy or relapse, whichever comes first)"
16110587|NCT02084550|Dietary Supplement|Vaminolac|Vaminolac with an amino acid content corresponding humane breast milk.
16110588|NCT02084550|Other|Saline|Intravenous isotonic saline with a sodium chloride content of 9mg/ml.
16110589|NCT02084537|Procedure|Endoscopic treatment|Treated by single or multiple transmural cystogastrostomy tracts, 15mm balloon dilation, two 7fr double pigtail plastic stents or lumen-apposing metal stents and nasocystic drainage catheter, with or without endoscopic necrosectomy as needed.
16110590|NCT02084537|Procedure|Minimally invasive surgical necrosectomy|Video-assisted retroperitoneal debridement (VARD) or laparoscopic cystogastrostomy with internal debridement.
16110591|NCT02084524|Procedure|Malnutrition screening and perioperative nutritional support|"Multidisciplinary training sessions for malnutrition and malnutrition risk screening, postoperative nutritional procedures according to the ESPEN Guidelines
~Preoperative Geriatric evaluation : eligibility criteria, nutritional status, previous history, comorbidities, clinical examination, activities of daily living (ADL) and Instrumental activities of daily living (IADL)
~Implementation of an adapted nutritional support based on ESPEN Guidelines"
16110592|NCT02084511|Drug|Placebo to BI 1026706 solution|Placebo to BI 1026706 solution
16110593|NCT02084511|Drug|BI 1026706|BI 1026706
16110594|NCT02084511|Drug|Placebo to BI 1026706 tablet|Placebo to BI 1026706 tablet
16110595|NCT02084511|Drug|Celecoxib|Celecoxib capsule
16110596|NCT02084498|Device|Automated bolus calculator|Training in Advanced Carbohydrate Counting and the use of an automated bolus calculator according to the BolusCal concept.
16110597|NCT02084498|Behavioral|Advanced Carbohydrate Counting|Training in advanced carbohydrate counting.
16110598|NCT02084485|Drug|PH-797804|30 MG Single dose
16110599|NCT02084485|Drug|Placebo|matching placebo
16110600|NCT02084472|Other|Baby oil|patient in study 1, arm B washed unscented liquid paraffin (baby oil) in place of aqueous cream
16110601|NCT02084472|Other|petroleum jelly|patients in this arm, use petroleum jelly (vaseline), replacing emulsifying ointment as a moisturiser
16110602|NCT02084472|Other|Glycerine:petroleum jelly 2:1|patients in this arm use glycerine and petroleum jelly mixed at a ratio of 2:1 in place of cetomacrogol as a moisturiser
16110603|NCT02084459|Behavioral|Autonomy-supportive counselling (GSD)|GSD, an educational method, comprising 32 semi-structured reflection sheets inviting the patients in groups of 4 through 8 sessions of 150 minutes' duration to reflect on the patient's own situation and to be active in co-operation with the nurses.
16110604|NCT02084446|Drug|Everolimus|Everolimus: initial dose of 1 mg twice a day starting at Day 1. Dose will be adjusted to keep everolimus trough levels between 3 and 8 ng/mL.
16110605|NCT02084446|Drug|Very Low Tacrolimus|Tacrolimus: initial dose of 0.05 mg/kg twice a day starting at Day 1. Dose will be adjusted to keep tacrolimus trough levels between 4 and 7 ng/mL during the first 3 months and 2 and 4 ng/mL thereafter.
16110606|NCT02084446|Drug|Low Tacrolimus|Tacrolimus: initial dose of 0.05 mg/kg twice a day starting at Day 1. Dose will be adjusted to keep tacrolimus trough levels between 4 and 7 ng/mL.
16110607|NCT02084446|Drug|Steroids|Corticoids: endovenous Methylprednisolone will be administered 30-60 minutes before the first 3 doses of r-ATG: 250 mg (D0) and 125 mg (D2 and D4); Prednisone, 10 mg per oral, will be administered before the last dose of r-ATG (D6). Maintenance with Prednisone at post-transplant period will be performed in accordance with center local practice, i.e., only in patients with chronic previous use of corticosteroids, as well as in patients with autoimmune disease (systemic lupus erythematous, rheumatoid arthritis, etc).
16110651|NCT02084082|Drug|Metformin ER|2x Metformin ER tablets
16110608|NCT02084446|Drug|Thymoglobulin|All patients will receive induction with rabbit Thymoglobulin (r-ATG) in four doses of 1.5 mg/kg (maximum total dose of 6 mg/kg), administered according to center local practice (before graft revascularization and at days 2, 4, and 6 post-transplant).
16110609|NCT02084446|Drug|Sodium Mycophenolate|Sodium Mycophenolate: initial dose of 720 mg twice a day starting at Day 1.
16110610|NCT02084433|Procedure|intraosseous anaesthesia using a computerized system|"1 / Anesthesia of periosteum (Articaine 1/100000) 2 / penetration of the needle rotated to the apex 3 / osteocentral injection "
16110611|NCT02084433|Procedure|conventional anasthesia|para-apical maxillary and locoregional mandibular (Articaine 1/100000) anaesthesia
16110612|NCT02084420|Drug|Ilaprazole|10mg 2 BID( 2 times / day), before breakfast and dinner
16110613|NCT02084420|Drug|Pantoprazole|40mg, BID(2 times / day), before breakfast and dinner
16110614|NCT02084407|Other|Clinical examination, skin biopsy, blood and urine sampling|
16110615|NCT02084381|Device|MCO-Ci 400|hemodialysis
16110616|NCT02084381|Device|Revaclear 400|hemodialysis
16110617|NCT02084368|Procedure|Nerve block|Patients in this group were assigned to receive lumbar plexus block and sciatic nerve block both using 0.33% ropivacaine 30ml guided by PNS
16110618|NCT02084368|Procedure|Combined spinal and epidural anesthesia|Combined spinal and epidural anesthesia were performed in patients of this group with 0.5% hyperbaric bupivacaine 8~10mg at L2-3 or L3-4.
16110619|NCT02084368|Drug|Ropivacaine|Patients will be assigned to receive lumbar plexus block and sciatic nerve block both using 0.33% ropivacain 30ml guided by PNS.
16110620|NCT02084368|Drug|Bupivacaine|Combined spinal and epidural anesthesia will be performed in patients with 0.5% hyperbaric bupivacaine 8~10mg.
16110621|NCT02084355|Drug|oral oxycodone|
16110622|NCT02084355|Drug|oral hydromorphone|
16110623|NCT02084355|Drug|fentanyl patch|
16110624|NCT02084342|Drug|tranexamic acid and sodium chloride injection|10mg/kg, IV (in the vein) for 30min, before incision. then at 1mg/kg/h, IV pump, until the surgery is over.
16110625|NCT02084342|Drug|normal saline|100ml, IV for 30min,before incision.
16110626|NCT02084342|Drug|desmopressin acetate injection|0.3μg/kg dissolved in 100ml NS，IV for 30min，before incision.
16110627|NCT02084329|Device|Weighted Compression Vest|
16110628|NCT02084316|Behavioral|One4All|Participants with HIV-positive screening results on EIA will immediately have their blood drawn for CD4 and VL tests. Participants will receive post-screening test counseling. Two venous blood samples will be collected-one for immediate numeration of CD4 T-lymphocytes in the same hospital lave using PIMA POC CD4 analyzer and the other for later VL testing at the province CDC which takes 10-15 days. Participant will be notified in person of their CD4 results on the same day and provided post-CD4 test counseling. Counseling in the One4all intervention has been modified from the national SOC guidelines due to the different order of tests and the shortened time period between screening and CD4 testing. The participant will be provided with a tentative assessment of ART eligibility based on CD4 results and other factors. Those who are eligible for ART are encouraged to seek HIV care at the study hospitals via China's National Free ART program.
16110629|NCT02084316|Behavioral|Standard of Care|"The control condition is the current standard of care (SOC) utilized within the county hospitals in Guangxi China. This SOC has some variability between counties but in general follows the national policies. After the initial positive screening on EIA and subsequent repeat screening, participants will receive post-screening test counseling. Participants will then be tested by WB either at the same visit or a subsequent visit. The WB is sent offsite.
~After WB test results are reported to the hospital, the health care provider will contact the participant by phone. The participant will be asked to return to the hospital for results and post-WB test counseling. At this visit, a blood sample will be collected for CD4 testing, and an initial epidemiological investigation will be carried out.
~Once CD4 test results are available, participants must be located again to inform them of their results and ART eligibility and to provide post-CD4 test counseling."
16110630|NCT02084303|Other|Ferumoxytol injection after focal epileptic seizure followed by iron-sensitive MRI|
16110631|NCT02084290|Behavioral|Shared Decision Making Program|This study is cluster randomized by study-site, Subjects enrolled at intervention sites will access an educational program and risk prediction tool. Their decisions about treatments will be compared to subjects that did not view the educational program or risk prediction tool.
16110632|NCT02084277|Device|Self-ligating brackets (SLB)|
16110633|NCT02084277|Device|Conventional brackets (CB)|
16110634|NCT02084251|Drug|PB-119|
16110635|NCT02084238|Drug|Interleukin-2|Patients receive low dose recombinant human Interleukin-2（HrIL-2） (1 million units every other day subcutaneously (HrIL-2 1X 106, ip, Qod) for a period of 14 days. After a 14-day rest, another cycle started) for 3-6 courses according to the situation of the disease.
16110636|NCT02084225|Procedure|ultrasound guided regional nerve block|participants were the physicians performing the procedure
16110637|NCT02084212|Other|Microperimetry|
16110638|NCT02084199|Drug|GLPG0634|100 mg oral tablet, intake once daily for 10 days
16110639|NCT02084186|Other|herb-partitioned moxibustion|Ignited moxa cones are placed upon herbal cake. Herbs are smashed into powder. Every 2.8g medicine powder mix with 3g millet wine and then be pressed into herbal cakes which are 28mm in diameter and 7mm in high with a specific mould. Then the herbal cake with a moxa cone will be fixed on Tianshu and Shangjuxu.
16110640|NCT02084186|Other|bran-partitioned moxibustion|Ignited moxa cones are placed upon bran cake. Every 2.8g bran powder mix with 3g millet wine and then be pressed into bran cakes which are 28mm in diameter and 7mm in high with a specific mould. Then the bran cake with a moxa cone will be fixed on Tianshu and Shangjuxu.
16110641|NCT02084173|Behavioral|MET + CRA|
16110642|NCT02084147|Device|positron emission tomography|Undergo PET
16110643|NCT02084147|Device|computed tomography|Undergo CT
16110644|NCT02084147|Device|magnetic resonance imaging|Undergo MRI
16110645|NCT02084134|Drug|hydrocortisone|100mg at the time of surgery
16110646|NCT02084134|Drug|dexamethasone|0.5mg every 6 hours for a total of four doses
16110647|NCT02084121|Biological|Enriched Hematopoetic Stem Cell Infusion|Enriched Hematopoetic Stem Cell Infusion
16110648|NCT02084108|Other|intervention|intervention group that will be provided, in addition, in-home multidimensional geriatric assessment with access to a 24h/7 day a week call service, and coordinated long-term follow-up.
16110655|NCT02084056|Drug|Linagliptin/Metformin FDC|Linagliptin/Metformin FDC
16110656|NCT02084043|Drug|Nebulization of Amikacin during NIV (RR: 15 cycles/minute)|500 mg/4 mL Amikacin nebulized using vibrating mesh nebulizer associated with a single limb bilevel ventilator. The nebulizations are considered as finished when there is no visible evidence of nebulization for a period of 30 seconds. The NIV is set with an IPAP of 15 cmH2O and EPAP of 5 cmH2O. The lung model is simulated with a respiratory rate of 15 cycles/minute
16110657|NCT02084043|Drug|Nebulization of Amikacin during NIV (RR: 25 cycles/minute)|500 mg/4 mL Amikacin nebulized using vibrating mesh nebulizer associated with a single limb bilevel ventilator. The nebulizations are considered as finished when there is no visible evidence of nebulization for a period of 30 seconds. The NIV is set with an IPAP of 15 cmH2O and EPAP of 5 cmH2O. The lung model is simulated with a respiratory rate of 25 cycles/minute
16110658|NCT02084017|Device|Prevena (Negative Pressure Wound Therapy Device)|No other details required.
16110659|NCT02084017|Device|Standard Tegaderm (3M Healthcare, St. Paul, MN) adhesive dressing|
16110660|NCT02084004|Drug|Bifidobacterium viable pharmaceutics|
16110661|NCT02084004|Drug|Berberine Hydrochloride|
16110662|NCT02083991|Drug|Steroid-free low TAC-arm: Thymoglobulin Standard low-TAC arm: Simulect, prednisolon|
16110663|NCT02083978|Other|MRI scanning|
16110664|NCT02083965|Biological|rFVIIIFc|Administered as specified in the treatment arm.
16110665|NCT02083952|Other|Swaddle Blanket|Two arms involve varying time spent in blanket
16110666|NCT02083926|Drug|Ketamine|Ketamine (a single 0.5mg/kg intravenously over 40 minutes).
16110667|NCT02083926|Other|Saline|Saline (a single 0.5mg/kg intravenously over 40 minutes).
16110668|NCT02083913|Behavioral|Telehealth supervised exercise training|Endurance and strength training (3x/week during 12 weeks)
16110669|NCT02083900|Device|Banana Leaf Dressing|Banana leaf dressing will be prepared by cutting the mid rib of the leaf cutting the leaf into standard size of 12 x 12 inches to facilitate packing. The leaves are rolled and packed in polypropelene bags and subject to gamma irradiation or packed in paper bags for autoclaving. The Banana Leaf Dressing site will receive a single layer of banana leaf without any topical antibiotic applied to the wound followed by a layer of dry gauze for absorption of exudates. The dressing is secured with cling wrap to maintain an occlusive environment. This is then covered by rolled gauze and elastic bandage.
16110670|NCT02083900|Drug|Hydrocolloid Dressing (DuoDERM CGF)|The donor under HCD was covered with hydrocolloid (DuoDERM CGF). The hydrocolloid dressing was cut to the size of the donor site with an overlap of at least 2 centimeter around the wound edge. After pulling off the adhesive backing, care was taken to ensure that the adhesive was in direct contact with the raw surface. This was likewise covered with a top dressing of gauze for absorption of exudates and an elastic bandage to secure dressing.
16110671|NCT02083887|Biological|ChAd63 ME-TRAP / MVA ME-TRAP|Intramuscular administration of ChAd63 ME-TRAP 5 x 10^10 vp and MVA ME-TRAP 1 x 10^8 pfu
16110672|NCT02083874|Drug|CBD|
16110673|NCT02083861|Device|Sam Ultrasonic Diathermy Device|Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2.
16110674|NCT02083848|Other|7T MRI|Ultra high field magnetic resonance imaging
16110675|NCT02083822|Procedure|term MRI, executive EF functions testing|An MRI will be realized at term born between 25 and 32 weeks GA
16110676|NCT02083809|Drug|intravenous oxytocin|30 units of oxytocin added to 500ml of inert IV fluid (saline, lactated ringer)
16110677|NCT02083809|Drug|Intravenous Fluids and Electrolytes|500 ml of inert IV fluid
16110678|NCT02083796|Procedure|Shoulder impingement_TSM|A physiotherapist with 4 years of experience in manual therapy will administer the TSM targeting the middle thoracic spine of the subjects.
16110679|NCT02083796|Procedure|Asymptomatic_TSM|A physiotherapist with 4 years of experience in manual therapy administered the TSM targeting the middle thoracic spine of the subjects.
16110680|NCT02083796|Procedure|Shoulder impingement_sham|A physiotherapist with 4 years of experience in manual therapy administered the sham intervention targeting the middle thoracic spine of the subjects.
16110681|NCT02083796|Procedure|Asymptomatic_sham|A physiotherapist with 4 years of experience in manual therapy administered the sham intervention targeting the middle thoracic spine of the subjects.
16110682|NCT02083783|Drug|TRI102|formulation containing active moiety (amphetamine)
16110683|NCT02083783|Other|Placebo|formulation without active moiety
16110684|NCT02083770|Behavioral|Cancer Clinical Trials Education Program|Hispanic Americans are underrepresented in cancer clinical trials. The purpose of this study is to develop and test programs designed to reduce barriers and increase facilitators associated with cancer clinical trials participation for Hispanic Americans.
16110685|NCT02083744|Behavioral|PsychoEducational Support|
16110686|NCT02083744|Behavioral|Usual Care|Standard Heart Failure Care
16110687|NCT02083731|Biological|MSCs|
16110688|NCT02083718|Biological|PBSC|
16110689|NCT02083718|Biological|MSCs|
16110690|NCT02083705|Procedure|CC+SI|Chest compression will be superimposed by sustained inflation during CPR
16110691|NCT02083705|Procedure|3:1 CPR|CPR using 3:1 ratio (control group)
16110692|NCT02083692|Drug|Metformin|
16110693|NCT02083679|Drug|Part 1: Sym004 6 mg/kg + Cisplatin/Gemcitabine|Sym004 will be administered as an intravenous infusion at a dose of 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject meets any of the criteria for subject withdrawal, or withdrawal from the investigational medicinal product (IMP) in combination with platinum-doublet chemotherapy regimen of cisplatin/gemcitabine (cisplatin 75 mg/m^2 on Day 1 plus gemcitabine 1250 mg/m^2 on Days 1 and 8 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
16110694|NCT02083679|Drug|Part 1: Sym004 6 mg/kg + Cisplatin/Pemetrexed|Sym004 will be administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject meets any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of cisplatin/pemetrexed (cisplatin 75 mg/m^2 plus pemetrexed 500 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
16110780|NCT02083068|Biological|Vaccine PvCS N+C|Vaccine PvCS N+C 60 mcg, freeze dried powder, Batch n°P0RGA, Exp: 18.10.2015, at month 0
16112431|NCT02070471|Drug|LC28-0126 Dose C|LC28-0126 Dose C
16110695|NCT02083679|Drug|Part 1: Sym004 6 mg/kg + Carboplatin/Paclitaxel|Sym004 will be administered as an intravenous infusion at a dose 6 mg/kg weekly until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject meets any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin area under the concentration-time curve (AUC) = 6 milligram per millilitre per minute [mg/mL/min] plus paclitaxel 225 mg/m^2 on Day 1 of 3-Week cycle intravenously for a maximum of 6 treatment cycles).
16110696|NCT02083679|Drug|Part 1: Sym004 6/12 mg/kg + Carboplatin/Paclitaxel|Sym004 will be administered as an intravenous infusion at a dose 6 mg/kg on Day 1 and 12 mg/kg on Day 8 of a 3-Week cycle until unacceptable toxicity, progressive disease, withdrawal of consent, or until the subject meets any of the criteria for subject withdrawal, or withdrawal from the IMP in combination with platinum-doublet chemotherapy regimen of carboplatin/paclitaxel (carboplatin AUC = 6 mg/mL/min plus paclitaxel 225 mg/m^2 on Day 1 of every 3-Week cycle intravenously for a maximum of 6 treatment cycles).
16110697|NCT02083666|Drug|SOBI002|Test Product
16110698|NCT02083666|Drug|Placebo|Reference product
16110699|NCT02083653|Drug|Sym004 (12 mg/kg)|Sym004 is a 1:1 mixture of two mAbs (futuximab and modotuximab) which bind to two non-overlapping epitopes of the EGFR.
16110700|NCT02083653|Drug|Sym004 (9/6 mg/kg)|Sym004 is a 1:1 mixture of two mAbs (futuximab and modotuximab) which bind to two non-overlapping epitopes of the EGFR.
16110701|NCT02083653|Other|Best Supportive Care (BSC)|BSC is the best palliative care as per Investigator's discretion, excluding antineoplastic agents. BSC may include, but is not limited to, antibiotics, analgesics, antiemetics, blood transfusions, and nutritional support.
16110702|NCT02083653|Drug|Fluorouracil (5-FU)|5-FU will be administered at doses and schedules as per Investigator's discretion and in line with the local package insert.
16110703|NCT02083653|Drug|Capecitabine|Capecitabine will be administered at doses and schedules as per Investigator's discretion and in line with the local package insert.
16110704|NCT02083640|Drug|Palbociclib Formulation Reference|125 mg single dose of palbociclib formulation with 16 micrometer API particle size and dissolution level 1, which is representative of the intended commercial hard gelatin capsule.
16110705|NCT02083640|Drug|Palbociclib Formulation Test|125 mg single dose of palbociclib formulation with 41 micrometer API particle size and dissolution level 1
16110706|NCT02083640|Drug|Palbociclib Formulation Test|125 mg single dose of palbociclib formulation with 16 micrometer API particle size and dissolution level 2
16110707|NCT02083627|Drug|rosuvastatin|Oral
16110708|NCT02083627|Drug|fidaxomicin|Oral
16110709|NCT02083614|Procedure|to clamp or release the catheter for 2 days before removal|
16110710|NCT02083601|Behavioral|Parent Forum|In-person psychoeducational workshop that provides education (including problem-solving training) and psychological/peer support for caregivers of youth with SCI.
16110711|NCT02083601|Behavioral|Psychological support|Outreach from a mental health professional in the form of monthly phone calls for 12 months.
16110712|NCT02083588|Device|dTMS|All subjects will receive prefrontal deep rTMS of H1 Coil (75 trains of 2 seconds, 20 Hz, with 20 seconds inter-train intervals, up to 120% of motor threshold, a total of 3000 pulses per session), for 4 weeks, 5 days a week, overall 20 sessions.
16110713|NCT02083575|Drug|Vitamin C, Defriprone, deferisarox|adjuvant vitamin c with iron chelator.
16110714|NCT02083575|Drug|deferiprone , deferesarox|iron chelator
16110715|NCT02083549|Other|Blood collection|After transfusion of each shipment of blood products outlined in the current Massive Transfusion Protocol one 2.7mL citrated blood sample will be collected from the subject through the 5th shipment of blood products. A final sample will be collected 24 hours following the discontinuation of the massive transfusion protocol.
16110716|NCT02083536|Radiation|Low Dose Fractionated Whole Abdominal Radiation Therapy|A single fraction of LDFWART will be given 6-8 hours after the start of morning administration of Docetaxel for 6 cycles (the time of the start Docetaxel will be counted as the frame of reference for when the LDFWART can be given).
16110717|NCT02083536|Drug|Docetaxel|Chemotherapy will consist of 6 cycles of Docetaxel. Each cycle will follow standard of care and will be scheduled every 3 weeks ± 3 days. Chemotherapy should be administered in the morning to allow 6-8 hours before Radiation Therapy. On Day 1 of each cycle, chemotherapy will consist of Docetaxel 60 mg/m² infused intravenously over 30-60 minutes (with premedication of dexamethasone 10 mg given IV 30-60 minutes prior to docetaxel administration).
16110718|NCT02083523|Behavioral|Motivational Interview with Normative Feedback|NOrmative Feedback (NF) contrasts and individual's substance use to available norms for one's reference group (i.e., descriptive norms.) Essentially, NF highlights how an individual's behavior is non-normative, which in turn, is thought to lead to reduced substance use.
16110719|NCT02083523|Behavioral|Motivational Interview|The Motivational Interview (MI) addresses ambivalence about change. It's effects are mediated by how well counselors evoke change talk, or in-session client utterances about the: need for; commitment to; ability to; or steps needed, to change.
16110720|NCT02083510|Drug|Colchicine|
16110721|NCT02083497|Other|rigid bandage|
16110722|NCT02083497|Other|elastic bands|
16110723|NCT02083497|Other|without the use of banding|
16110724|NCT02083484|Biological|Pembrolizumab|Each participant will receive pembrolizumab every 3 weeks for up to 2 years or until confirmed radiographic disease progression, unacceptable toxicity, confirmed positive pregnancy test, withdrawal of consent, or pembrolizumab approval in the participant's country.
16110725|NCT02083471|Dietary Supplement|Specific Oral Tolerance Induction with Egg or Cow's milk|
16110726|NCT02083458|Procedure|Catheterization of the axillary vein.|
16110727|NCT02083445|Other|cognitive activities|Participants followed a day of cognitive activities 1 day (1 hour/day) per week during 12 weeks.
16110728|NCT02083445|Other|Exercise program|Exercise program of endurance, resistance and proprioception exercises, comprising three sessions per week and muscle electro-stimulation was applied using the Compex Vitality® vascular and capillarization program with electrodes fixed in quadriceps and abdominal muscles or cycling exercise.
16110729|NCT02083445|Device|Muscle electro-stimulation|A program of intermittent hypobaric hypoxia and muscle electro-stimulation of 3 days (3 hours/day) per week during 12 weeks
16110730|NCT02083445|Other|Intermittent hypobaric hypoxia|
16110781|NCT02083068|Biological|SSN Montanide ISA-51|SSN Montanide ISA-51 1 mL
16110731|NCT02083432|Behavioral|5 session of CBT performed by specially trained dentists|"A total of 60 participants are randomly assigned to a 5-weeks waiting list Control Group or directly enrolled to the 5-session of CBT treatment Group.
~The participants in the waiting list Control Group are enrolled to the treatment Group (5 sessions of CBT) after 5 weeks if they still meet the diagnostic criteria of a specific phobia (according to DSM-IV)."
16110732|NCT02083419|Device|LVAD CRT|The following procedures will be performed: limited echocardiogram, an adjustment to the CRT device's programmed settings, follow-up in 30 days to adjust the CRT device's programmed settings. In addition, quality of life questionnaires will be filled out and a 6 minute walk test will be completed.
16110733|NCT02083406|Drug|800mg OZ439 prototype formulation 1|
16110734|NCT02083406|Drug|800mg OZ439 prototype formulation 2|
16110735|NCT02083406|Drug|800mg OZ439 prototype formulation 3|
16110736|NCT02083406|Drug|960mg PQP|
16110737|NCT02083380|Drug|Artefenomel 800mg: piperaquine 640mg|Active, loose combination
16110738|NCT02083380|Drug|Artefenomel 800mg: piperaquine 960mg|Active, loose combination
16110739|NCT02083380|Drug|Artefenomel 800mg: piperaquine 1440mg|Active, loose combination
16110740|NCT02083354|Drug|Dabrafenib|Dabrafenib will be provided as 50 mg and 75 mg capsules. Each capsule will contain 50 mg or 75 mg of free base (present as the mesylate salt)
16110741|NCT02083354|Drug|Trametinib|Trametinib study medication will be provided as 0.5 mg and 2.0 mg tablets. Each tablet will contain 0.5 mg or 2.0 mg of trametinib parent (present as the DMSO solvate)
16110742|NCT02083341|Device|Lelo® Siri vibrator|external vibration device
16110743|NCT02083341|Device|Lelo® Siri vibrator with vibration component removed|external vibration device - sham
16110744|NCT02083328|Dietary Supplement|Caffeine|Caffeine will be filled in gelatine capsules and administrated in a dosage of 6mg per kg body mass
16110745|NCT02083328|Dietary Supplement|Placebo (Mannitol)|Mannitol filled in gelatine capsules
16110746|NCT02083315|Drug|TRV130 1.5 mg|TRV130 1.5 mg IV x 1 dose
16110747|NCT02083315|Drug|TRV130 3 mg|TRV130 3 mg IV x 1 dose
16110748|NCT02083315|Drug|TRV130 4.5 mg|TRV130 4.5 mg IV x 1 dose
16110749|NCT02083315|Drug|Morphine 10 mg|Morphine 10 mg IV x 1 dose
16110750|NCT02083315|Drug|Placebo|Dextrose 5% in water IV x 1 dose
16110751|NCT02083302|Behavioral|SCREAM Theater Dose 1|Intervention 1: A three part program: a skit acted out by peer educators that depicts a sexual assault; an in-character question and answer session; and an out-of-character information session.
16110752|NCT02083302|Behavioral|SCREAM Theater Doses 2 & SCREAM Theater Dose 3|"Dose 2: Scenes from the skit from Session 1 are re-created with small groups of students, but stop at certain points to allow audience members to explore different bystander intervention possibilities.
~Dose 3: The six scenes outlined in Session 2 are presented individually to small groups of student participants; specifically outlining potential points of bystander intervention."
16110753|NCT02083302|Behavioral|SCREAM Theater Dose 4|Booster Session
16110754|NCT02083289|Drug|ONO-9054|
16110755|NCT02083289|Drug|Latanoprost|
16110756|NCT02083276|Drug|Pivmecillinamhydrochlorid|PO 400 mg x3 for 7 days
16110757|NCT02083263|Device|Bilevel|3 months
16110758|NCT02083263|Device|PEP mask|3 months
16110759|NCT02083250|Procedure|Allogeneic Bone Marrow Transplantation|Undergo allogeneic peripheral blood stem cell or bone marrow transplant
16110760|NCT02083250|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic peripheral blood stem cell or bone marrow transplant
16110761|NCT02083250|Biological|Anti-Thymocyte Globulin|Given IV
16110762|NCT02083250|Drug|Busulfan|Given IV
16110763|NCT02083250|Drug|Clofarabine|Given IV
16110764|NCT02083250|Drug|Fludarabine Phosphate|Given IV
16110765|NCT02083250|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo allogeneic peripheral blood stem cell or bone marrow transplant
16110766|NCT02083250|Other|Pharmacological Study|Correlative studies
16110767|NCT02083250|Drug|Vorinostat|Given PO
16110768|NCT02083237|Behavioral|Behavioural Intervention Program|People with MCI and their close family member (80% spouses) participate jointly in the first hour, which provides education about MCI, lifestyle influences on cognitive health, and community resources. During the second hour, family members participate in a separate psychosocial group intervention, while the individuals with MCI participate in memory training. The first 6 of the 8 sessions occur weekly, the 7th occurs as a 1-month follow-up session and the 8th as a 3-month follow-up session. These follow-up sessions provide support to sustain positive outcomes and provide further assistance with resolving continued challenges.
16110769|NCT02083211|Drug|mAb Nimotuzumab|This group will receive a dose of 200 mg mAb hR3 (weekly over 18 weeks) plus chemotherapy (6 cycles every 21 days of Cisplatin (CDDP) 50 mg/m2 on day 1/, Vinorelbine 30 mg/m2 on day 1 and day 8)
16110770|NCT02083211|Device|Placebo|This group will receive a placebo in addition to chemotherapy in a similar regimen. Once the chemotherapy is completed a maintenance dose will be administered with 200 mg/dose of mAb hR3 every 14 days until progression.
16110771|NCT02083185|Drug|Relugolix|Relugolix tablets
16110772|NCT02083185|Drug|Leuprorelin|Leuprorelin subcutaneous injection
16110773|NCT02083172|Device|Ultrasound Cardiac Output Monitor and 2 D-Echo|Hemodynamic measurements obtained by 2D-Echo and USCOM will be compared.
16110774|NCT02083120|Device|NHF therapy|AIRVO 2 device therapy is either a humidifier with integrated flow generator that delivers warmed and humidified respiratory gases to spontaneously breathing patients through a variety of patient interfaces. Flow rates up to 60 L/min are available to the user, depending on the patient interface and mode of operation.In this study, flow rates of 20 L/min and 35 L/min will be compared.
16110775|NCT02083120|Other|Long term Oxygen Therapy (LOT)|Oxygen will individually be added to NHF in order to achieve stable oxygen saturation by pulse oximetry (SpO2) values of 88% to 92%.
16110776|NCT02083107|Drug|Misoprostol|Comparison of different routes of administration of 400 micro gram misoprostol
16110777|NCT02083107|Other|Placebo|
16110778|NCT02083081|Behavioral|Community level intervention|Community intervention plus individual counseling
16110779|NCT02083068|Biological|Vaccine PvCS N+C+R|Vaccine PvCS N+C+R 60 mcg, freeze dried powder, Batch n°P0RGB, Exp: 18.10.2015 At month 2 and 6
16110942|NCT02081755|Drug|Imuran|0.5 mg/kg to 2 mg/kg QD for 12 months
16110782|NCT02083055|Drug|Dexmedetomidine|controlled hypotensive anesthesia with dexmedetomidine compare with nitroglycerin on anesthetic outcome such as analgesic use, time to eye opening, follow verbal command, extubation and early postoperative pain
16110783|NCT02083055|Drug|Nitroglycerin|controlled hypotensive anesthesia with nitroglycerin compared with dexmedetomidine on anesthetic outcomes such as analgesic use, time to eye opening, follow verbal command, extubation, and early postoperative pain.
16110784|NCT02083029|Procedure|Simulated dive reflex|All subjects undergo simulated dive reflex, with 30s facial immersion and continuous HR and BP monitoring with Nexfin over a period of 6 minutes.
16110785|NCT02083016|Device|Ablation guided by conventional mapping.|Substrate mapping and ablation of ventricular tachycardia.
16110786|NCT02083016|Device|Ablation guided by ultra-high density mapping with multielectrode catheter.|Substrate mapping and ablation of ventricular tachycardia.
16110787|NCT02083003|Dietary Supplement|Polyamine low-diet|
16110788|NCT02083003|Dietary Supplement|Liberal alimentation|
16110789|NCT02082990|Behavioral|Face-to-Face Brief Intervention|One face-to-face Brief Intervention which is provided by General Practitioner or Nurse
16110790|NCT02082990|Behavioral|Online Brief Intervention|Primary care-based facilitated access to an alcohol reduction website (Brief Intervention)
16110791|NCT02082977|Drug|GSK2816126|GSK2816126 will be supplied as a solution containing 15 milligram per milliliter (mg/mL) GSK2816126 in water for injection.
16110792|NCT02082964|Other|SCIM|after lecture students had rotation in 6 groups through 6 stations, trained and practiced under supervision of 6 instructors about Initial Steps, Positive Pressure Ventilation(PPV), Intubation, Chest Compressions, Medications and management of advanced resuscitation
16110793|NCT02082964|Other|video|video about neonatal resuscitation presented then students repeated the video. Workshops was based on NRP and lasted 6 hours for each group the contentof the video was based on the educational content of the course
16110794|NCT02082951|Behavioral|Empathic behaviour by nurses.|The empathic behaviour in group 1 was performed by a trained nurse.
16110795|NCT02082951|Behavioral|Empathic behaviour by family.|Considered the empathic behaviour performed by family as a hospital visit with greater than 45 minutes duration, a person with whom the patient had a good relationship, he considered it to be important and welcome. It is emphasized that these families did not have any prior training and after the visit, patients were asked about how the visit had been seeking to detect the presence of any conversations that have been unpleasant for patients and, if present, the patients were excluded from the study.
16110796|NCT02082938|Device|Bracing|Twice a week, for a period of 5 weeks, before the sessions in the physiotherapy clinic the patients participating in the study were asked to walk at a self-selected speed on flat ground along a corridor 50 meters long, with the brace being used for fifteen minutes of gait retraining of the affected side.
16110797|NCT02082925|Other|Patient has to get up his hand when he defined his dyspnea threshold during 6MWT|
16110798|NCT02082912|Drug|D-cycloserine|D-cycloserine 100mg PO twice weekly (Monday and Wednesday) for three weeks
16110799|NCT02082912|Other|Placebo|Placebo pill PO twice weekly (Monday and Wednesday) for three weeks
16110800|NCT02082912|Device|HandMentor Pro|The HandMentor Pro (Kinetic Muscles Inc.) is a robotic device that has recording electrodes. The device gives feedback during various activities requiring varying levels of wrist control. The main goal of the hand robot is to improve active range of motion about the wrist and fingers and wrist control. The robotic therapy will be done over 3 consecutive weeks for 2 hours each session (days 1, 3, 5, 8, 10, 12, 15, 17 and 19, for 18 hours total).
16110801|NCT02082899|Drug|Active Comparator EBI-005 5 mg/mL|
16110802|NCT02082899|Drug|Placebo Comparator|
16110803|NCT02082860|Genetic|rAAV2/5-PBGD vector dosage 1|Intravenous injection of rAAV2/5-PBGD vector, single administration on Day 1.
16110804|NCT02082860|Genetic|rAAV2/5-PBGD vector dosage 2|Intravenous injection of rAAV2/5-PBGD vector, single administration on Day 1.
16110805|NCT02082860|Genetic|rAAV2/5-PBGD vector dosage 3|Intravenous injection of rAAV2/5-PBGD vector, single administration on Day 1.
16110806|NCT02082860|Genetic|rAAV2/5-PBGD vector dosage 4|Intravenous injection of rAAV2/5-PBGD vector, single administration on Day 1.
16110807|NCT02082834|Other|abdominal MDCT examination|
16110808|NCT02082808|Drug|DTG|DTG is provided as 9 millimetre white, film-coated, round tablets debossed with SV 572 on one side and 50 on the other side
16110809|NCT02082808|Drug|DCV|DCV is provided as a plain, green, biconvex, pentagonal film-coated tablet
16110810|NCT02082782|Procedure|Irreversible electroporation (IRE)|Percutaneous (CT-guided) or open (US-guided) irreversible electroporation of central colorectal liver metastasis.
16110811|NCT02082769|Drug|Febuxostat|
16110812|NCT02082769|Drug|Allopurinol|
16110813|NCT02082756|Drug|Bifidobacterium viable pharmaceutics|
16110814|NCT02082756|Drug|Berberine Hydrochloride|
16110815|NCT02082743|Behavioral|Outdoor activity in recess time|Outdoor activity in recess time
16110816|NCT02082730|Device|ASARM|The ASARM system combines objective and subjective measurements of sleep, rest and activity patterns by using a combination of low-cost devices and technologies. The patient wears a wrist-mounted Actigraphy device to measure their energy expenditure, and carries an electronic diary (a Smartphone app) for recording their activities and their subjective measures of mood and energy level. These synchronise daily with a remote server, accessible by the clinician through a web interface, to allow monitoring, data analysis and feedback to the patient.
16110817|NCT02082717|Drug|potassium chloride replacement|
16110818|NCT02082717|Drug|Experimental - 4% Sodium Bicarbonate|
16110819|NCT02082704|Behavioral|SE Game on DSME|Investigators created an online educational game by incorporating game mechanics into an evidence-based form of online education, termed 'spaced education' (SE). Based upon two psychology research findings (the spacing and testing effects), SE has been shown in randomized trials to improves knowledge acquisition, boosts learning retention for up to two years, and durably improves clinical behavior.
16110820|NCT02082704|Behavioral|SE Game on American History|Investigators created an online educational game by incorporating game mechanics into an evidence-based form of online education, termed 'spaced education' (SE). Based upon two psychology research findings (the spacing and testing effects), SE has been shown in randomized trials to improves knowledge acquisition, boosts learning retention for up to two years, and durably improves clinical behavior.
16110821|NCT02082691|Drug|G-202|Patient will receive G-202 for 3 days in a row, followed by 25 days without taking G-202. This cycle will be repeated every 28 days. Patient will receive G-202 as long as his/her cancer does not grow and the investigational drug side effects are tolerable.
16110822|NCT02082678|Drug|Ondansetron|Ondansetron is a serotonin receptor antagonist that is FDA-approved to treat nausea and vomiting caused by cancer therapy and surgery.
16110823|NCT02082678|Drug|Placebo|Inactive ingredient matching the active medication in appearance
16110824|NCT02082665|Drug|Rosuvastatin10 mg tablet|Commercially available Rosuvastatin 10 mg tablets will be supplied. Single oral dose of Rosuvastatin 10 mg will be administered on Day 1, 8 and 22
16110825|NCT02082665|Drug|Midazolam 3 mg syrup|Commercially available Midazolam syrup will be supplied.Single oral dose of Midazolam 3 mg syrup will be administered on Days 1, 8 and 22
16110826|NCT02082665|Drug|Dabrafenib 75 mg capsule|Dabrafenib 75mg will be supplied in the form of capsules. Oral dose Dabrafenib 150 mg (2 x 75 mg) BID will be administered at 12 h apart on Days 8 through 22 and 150 mg (2 x 75 mg) OD on Day 23.
16110827|NCT02082652|Drug|Etonogestrel|Etonogestrel single-rod subdermal implant (68mg/rod) is placed upon enrollment (day 0) and remains in place until participant requests removal or for the duration of active drug (currently approved for 3 years of use).
16110828|NCT02082639|Biological|Cervarix™|2 doses intramuscularly in the deltoid muscle of the non-dominant arm
16110829|NCT02082639|Biological|Havrix|2 doses intramuscularly in the deltoid muscle of the dominant arm
16110830|NCT02082626|Drug|Eribulin mesylate|
16110831|NCT02082613|Procedure|Lord´s procedure|
16110832|NCT02082613|Procedure|Sclerotherapy|
16110833|NCT02082600|Other|Sleep deprivation|This group will perform 24 sets of 10 maximum repetitions of eccentric contractions for quadriceps and than will keep awake for 60 hours (2 nights), followed by 1 night of sleep, all inside the lab. During whole protocol, it will be collected several blood samples for evaluation of hormones, cytokines and muscle damage parameters. It will be also evaluated isometric strength and pain.
16110834|NCT02082600|Other|Normal sleep|This group will perform 24 sets of 10 maximum repetitions of eccentric contractions for quadriceps and and will be able to sleep the 3 nights. During whole protocol, it will be collected several blood samples for evaluation of hormones, cytokines and muscle damage parameters. It will be also evaluated isometric strength and pain.
16110835|NCT02082561|Behavioral|Transdiagnostic Treatment (F-SET)|F-SET treatment consisted of five weekly individual sessions (approximately 50 minutes each). The participants learn to techniques and skills to help them reduce their anxiety. F-SET protocol is consistent with current CBT protocols for anxiety disorders.
16110836|NCT02082548|Other|Educational Intervention|This intervention will contain educational materials for both patients and providers that are specific to the needs in each participating country
16110837|NCT02082522|Drug|Photodynamic therapy-Photofrin|Photodynamic therapy (PDT) involves the i.v. injection of Photofrin (2 mg/kg) followed by the illumination of the tumor using a fiber optic device during an endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC). Two days after the injection, a laser light (180 J/cm(2)) will be applied to the tumor. A second light application will be given 96-120 hours after Photofrin injection if PDT could not initially be performed on all sides of the tumor. Post illumination, all patients will undergo stenting as part of standard medical care procedure. Up to 3 additional courses of PDT using a light dose of 120 J/cm(2) may be given at 3-month intervals.
16110838|NCT02082522|Procedure|Stenting procedure|As per standard medical procedures, stenting procedure consists in the placement of stents above the main tumors of the right and left hepatic bile ducts via endoscopic retrograde cholangiopancreatography (ERCP) or percutaneous transhepatic cholangiography (PTC) when the ERCP approach has been unsuccessful.
16110839|NCT02082522|Drug|Chemotherapy regimen|The regimen will comprise gemcitabine (1 000 mg/m(2)) followed by cisplatin (25 mg/m(2)), each administered on days 1 and 8 every 3 weeks (21 day-cycle) for four cycles. An additional 12 weeks of the same chemotherapy regimen may be administered if there is no disease progression or intolerable toxicity.
16110840|NCT02082496|Drug|Liraglutide|S.c. liraglutide 3.0mg once daily
16110841|NCT02082483|Other|Selective Screening|Patients randomized to selective-use of screening tests will not routinely undergo Myocardial Perfusion Scintography or Dobutamine Stress Echocardiography. If patients develop symptoms of CAD at any time, they will undergo investigations as per the usual standard of care.
16110842|NCT02082470|Other|follow-up care|Undergo survivorship care planning
16110843|NCT02082470|Other|active surveillance|Undergo cancer surveillance
16110844|NCT02082470|Other|questionnaire administration|Ancillary studies
16110845|NCT02082457|Drug|YKP10811 5mg|
16110846|NCT02082457|Drug|YKP10811 20mg|
16110847|NCT02082457|Drug|YKP10811 placebo|
16110848|NCT02082444|Other|Skipping lunch|
16110849|NCT02082418|Dietary Supplement|Alpha-lactalbumin|Subjects will ingest the liquid meal containing alpha-lactalbumin and carbohydrates (0.6 g/kg FFM protein + 0.3 g/kg FFM carbohydrates).
16110850|NCT02082418|Dietary Supplement|Whey|commercially available whey protein
16110851|NCT02082418|Dietary Supplement|Casein|commercially available casein protein
16110852|NCT02082405|Drug|bortezomib|Given SC or IV
16110853|NCT02082405|Drug|cyclophosphamide|Given PO
16110854|NCT02082405|Drug|dexamethasone|Given PO
16110855|NCT02082405|Other|laboratory biomarker analysis|Optional correlative studies
16110856|NCT02082405|Other|quality-of-life assessment|Ancillary studies
16110857|NCT02082392|Drug|Escitalopram|
16110858|NCT02082392|Drug|Placebo|A substance or treatment of no intended therapeutic value in a pill form.
16110859|NCT02082379|Behavioral|inhaled normal saline using different interfaces.|A Hudson nebulizer will be loaded with 3 mls of normal saline and operated at 7 L/min of wall air for 3 minutes with each scenario with a 5-minute interval between interfaces. The infants will be videotape while they receive inhaled aerosol, and sound will be captured. The camera will be positioned so the face of the parent holding the child will not be visible.
16110860|NCT02082366|Device|TCD monitoring of microembolic signal during procedure|monitoring of microembolic signal during procedure
16110861|NCT02082340|Behavioral|TB knowledge and socio-psychological counseling session|TB patients and their family members will participate in one-day counseling session provided by a trained psychologist and a TB nurse
16110862|NCT02082340|Other|SMS text messages|TB patients will receive SMS text messages every morning (except Sunday) during the whole ambulatory TB treatment phase as a reminder for taking the TB medication prescribed and provided by the TB physician
16110863|NCT02082340|Other|phone calls|Family members of the TB patients will receive phone calls every evening (except Sunday) during the whole ambulatory TB treatment phase to assure that the patient takes the medication prescribed and provided by the TB physician and to collect information on treatment adherence and possible side effects.
16110864|NCT02082340|Behavioral|Self-administered drug intake strategy|Once a week TB patients will receive the TB medication from their local outpatient TB centers and will use the medication every day (six days a week, except Sunday according to the TB treatment protocol) at home under supervision of a family member in charge.
16110865|NCT02082340|Behavioral|Educational leaflet|Educational leaflet containing information on TB infection; infection control measures; importance of TB treatment adherence and family support will be provided to all TB patients at the end of the counselling session
16110866|NCT02082327|Drug|IV migalastat HCl|
16110867|NCT02082327|Drug|IV placebo|
16110868|NCT02082327|Drug|oral migalastat HCl|
16110869|NCT02082314|Procedure|RFA Vertebroplasty|
16110870|NCT02082288|Other|Edessy ICSI Outcome Embryo Score|"EIOS:
~Age (ys) >35 (0) 30-35 (1) <30 (2) No of retrived oocyte <5 (0) 5-9 (1) ≥ 10 (2) No of EC embryos <2 (0) 2-4 (1) >4 (2) No of good quality embryos <3 (0) 3-5 (1) >5 (2) No of embryos transferred -------- (0) ≤2 (1) >2 (2)"
16110871|NCT02082275|Other|OB Nest|"Reduction in the number of clinic office visits
~Assignment to a specific nursing care team
~Support and direct interaction available through tools which supports mom's empowerment to address her concerns, care for herself and connect with OB as necessary between clinic visits.
~Empower and enable mothers to complete at home measurements for fetal heart rate, weight, and blood pressures.
~Augmentation of in-person visits between care providers and patients with video conversations.
~Maternal outcomes will be monitored through surveys and questionnaires."
16110872|NCT02082262|Drug|AGN-229666|One to two drops of AGN-229666 twice daily in each eye for 10 weeks.
16110873|NCT02082249|Drug|ABT-SLV187|Dose levels will be individually optimized
16110874|NCT02082236|Drug|Treatment Arm A: Sufenta®|Sufenta® intravenous (IV) (50 mcg/mL) 30 mcg infused over 1 minute
16110875|NCT02082236|Drug|Treatment B: Sufentanil SSM 30 mcg|single-dose SSM 30 mcg
16110876|NCT02082236|Drug|Treatment C: SSM 15 mcg|2 consecutive doses of SSM 15 mcg administered 20 minutes apart
16110877|NCT02082236|Drug|Treatment D: SSM 30 mcg|12 consecutive doses of SSM 30 mcg administered 1 hour apart
16110878|NCT02082223|Behavioral|Interventions to improve preop QOL/resilience deficits|Identify patients' and patients' care givers quality of life/resilience deficits and supply information and resources prior to undergoing complex GI surgery.
16110879|NCT02082210|Drug|Emibetuzumab|Administered Intravenously (IV)
16110880|NCT02082210|Drug|Ramucirumab|Administered Intravenously (IV)
16110881|NCT02082197|Drug|ABT-SLV176|ABT-SLV176 administered daily
16110882|NCT02082184|Device|Sensor Based Glucose Monitoring System|"Subjects will wear the Abbott Sensor Based Glucose Monitoring System (unmasked) for 6 months to monitor their glucose levels. Post completion of the 6 month intervention, subjects participating in this arm of the study will be given a further 6 month period of open access to the device.
~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
16110883|NCT02082184|Device|Standard Blood Glucose Monitoring|"Subjects will use an Abbott Blood Glucose Monitoring System (standard blood glucose meter) for 6 months to monitor their glucose levels. A 14-day masked wear of the Abbott Sensor Based Glucose Monitoring System is included for these subjects at the 6 month time point, to collect glycaemic variability data for comparison to the intervention group of the study.
~All subjects will wear a masked Abbott Sensor Based Glucose Monitoring System, for 14 days prior to randomisation."
16110884|NCT02082171|Other|Multidomain intervention|Multidomain preventive intervention designed by a multidisciplinary team on the basis of results of a comprehensive geriatric assessment
16110885|NCT02082158|Other|Study Procedures|Study activities include fit-testing, wearing the respirator while performing a series of motions that simulate healthcare worker tasks and completing a survey on the comfort and tolerability of the respirator worn.
16110886|NCT02082145|Device|NMES|Application of NMES device bilaterally, once a day, 5 times a week, for 10 weeks
16110887|NCT02082119|Radiation|Hypofractionated IMRT|Hypofractionated IMRT
16110888|NCT02082106|Other|Alpine skiing|
16110889|NCT02082106|Other|cross country skiing|
16110890|NCT02082106|Other|Indoor training (cycling)|
16110891|NCT02082093|Device|Telemedicine System|
16110892|NCT02082080|Other|Education|
16110893|NCT02082080|Other|Social support|
16110894|NCT02082067|Procedure|Adductor canal|Perinervous catheter (stimulong sono- Pajunk, Germany) will be insert in adductor canal through tuohy needle (18G, 100mm length) under ultrasound guidance.
16110895|NCT02082067|Procedure|Femoral|Perinervous catheter (stimulong sono- Pajunk, Germany) will be insert between femoral nerve and femoral artery through tuohy needle (18G, 100mm length) under ultrasound guidance.
16110896|NCT02082067|Procedure|Spinal Anesthesia|Spinal anesthesia will be perform at L3-L4 or L4-L5 level. Levobupivacaine 0,5% 12mg will be injected.
16110897|NCT02082067|Procedure|Local anesthetic infusion|Continuous infusion of levobupivacaine 0,125% at 8ml/h rate through perinervous catheter until 5th postoperative day.
16110898|NCT02082067|Procedure|Intravenous analgesia|Ketorolac 30mg 3 times/day and morphine Patients Control Analgesia (1mg/h, max 4mg/h) administered.
16110899|NCT02082067|Drug|Ropivacaine 0,75%|
16110900|NCT02082067|Drug|Levobupivacaine 0,5%|
16110901|NCT02082067|Drug|Levobupivacaine 0,125%|
16110902|NCT02082067|Drug|Ketorolac 30mg|
16110903|NCT02082067|Drug|Morphine|
16110904|NCT02082067|Device|stimulong sono, Pajunk, Germany|
16110905|NCT02082054|Drug|PSE 120 mg, CM 8 mg, Atr 0.36 mg|"Pseudoephedrine 120 mg, chlorpheniramine 8 mg, atropine 0.36 mg white, scored, tablets with M27 on scored side and plain on the other side"
16110906|NCT02082054|Drug|PSE 120 mg, CM 8 mg, Atr 0.24 mg|"Pseudoephedrine 120 mg, chlorpheniramine 8 mg, atropine 0.24 mg white, scored, tablets with M27 on scored side and plain on the other side"
16111031|NCT02081027|Drug|Riluzole|
16110907|NCT02082054|Drug|PSE 120 mg, CM 8 mg, Atr 0.12 mg|"Pseudoephedrine 120 mg, chlorpheniramine 8 mg, atropine 0.12 mg white, scored, tablets with M27 on scored side and plain on the other side"
16110908|NCT02082054|Drug|PSE 120 mg, CM 8 mg|Pseudoephedrine 120 mg, chlorpheniramine 8 mg tablets dosed BID
16110909|NCT02082054|Drug|Atropine 0.24 mg|"Atropine sulfate 0.24 mg white, scored, tablets with M27 on scored side and plain on the other side"
16110910|NCT02082028|Device|BGStar|
16110911|NCT02082028|Device|glucose meter|
16110912|NCT02082015|Device|Low frequency rTMS|Intensity: 100% of resting motor threshold; Location: Motor hotspot in primary motor cortex for the dominant hand; Frequency: 1Hz; Number of total stimuli: 1800; Coil orientation: tangential to scalp
16110913|NCT02081989|Procedure|Renal denervation|Renal denervation
16110914|NCT02081976|Behavioral|Integrated Care Group|The group (TG) consisted of periodontal treatment comprising one session of supragingival scaling and personalized oral hygiene instructions, followed by one to four sessions of subgingival scaling and root planing (SRP) by quadrant, under local anesthesia, in a period of 14 days. Individuals were be followed monthly during the first 6 months. In the follow-up sessions, professional plaque removal, oral hygiene instructions, cardiac support along with counseling reinforcement were be provided.
16110915|NCT02081976|Other|Standard Care Group|The group (TG) comprising one session of supragingival scaling followed by one to four sessions of subgingival scaling and root planing (SRP) by quadrant, under local anesthesia, in a period of 14 days.
16110916|NCT02081963|Drug|Amikacin|Nebulized 0.2g of amikacin and 2 mL of normal saline twice a day for 14 days in combination with standard treatment.
16110917|NCT02081963|Drug|Normal saline|Nebulized 3 mL of normal saline twice a day for 14 days in combination with standard treatment.
16110918|NCT02081950|Biological|Enoxaparin sodium|comparison of 2 different administration of drug
16110919|NCT02081937|Biological|anti-CD19-CAR vector-transduced T cells|
16110920|NCT02081924|Other|Kisspeptin 0.1|"Participants will receive kisspeptin hormone at a dose rate of 0.1nmol/kg/hour via a subcutaneous pump device for 8 days during the early follicular phase of their menstrual cycle.
~LH, FSH and oestradiol will be measured on day 1 and 8, at 10minute intervals for 8 hours and on Days 3 and 5 they will have a single blood measurement of the same hormones."
16110921|NCT02081924|Other|Saline|"Participants will receive placebo (saline) via a subcutaneous pump device for 8 days during the early follicular phase of their menstrual cycle.
~LH, FSH and oestradiol will be measured on day 1 and 8, at 10minute intervals for 8 hours and on Days 3 and 5 they will have a single blood measurement of the same hormones."
16110922|NCT02081924|Other|Kisspeptin 0.3|"Participants will receive kisspeptin hormone at a dose rate of 0.3 nmol/kg/hour via a subcutaneous pump device for 8 days during the early follicular phase of their menstrual cycle.
~LH, FSH and oestradiol will be measured on day 1 and 8, at 10minute intervals for 8 hours and on Days 3 and 5 they will have a single blood measurement of the same hormones."
16110923|NCT02081924|Other|Kisspeptin 1.0|"Participants will receive kisspeptin hormone at a dose rate of 1.0 nmol/kg/hour via a subcutaneous pump device for 8 days during the early follicular phase of their menstrual cycle.
~LH, FSH and oestradiol will be measured on day 1 and 8, at 10minute intervals for 8 hours and on Days 3 and 5 they will have a single blood measurement of the same hormones."
16110924|NCT02081911|Procedure|High Volume Adductor Canal Block|Adductor canal block performed in the distal thigh (1/3 of the total distance between the superior border of the patella and the femoral crease, cephalad to the patella) utilizing an injectate volume of 30 mL 0.25% bupivacaine/ epinephrine
16110925|NCT02081911|Procedure|Low Volume Adductor Canal Block|Adductor canal block performed in the distal thigh (1/3 of the total distance between the superior border of the patella and the femoral crease, cephalad to the patella) utilizing an injectate volume of of 10 mL 0.75% bupivacaine/ epinephrine
16110926|NCT02081911|Procedure|Femoral Nerve Block|Femoral nerve block with 10 mL 0.75 % bupivacaine/epinephrine
16110927|NCT02081898|Dietary Supplement|LCD|approximate 100 kcal/d caloric deficit
16110928|NCT02081885|Procedure|Tricalcium Phosphate / Chitosan|
16110929|NCT02081885|Procedure|Autologous Graft|
16110930|NCT02081859|Device|Embryoscope|The embryoscope is a microscope that allows for continuous time-lapse monitoring.
16110931|NCT02081859|Other|Conventional Criteria|
16110932|NCT02081846|Other|Nurse Home Visit|We will complete a single center, parallel, randomized, standard-of-care-controlled prospective study to determine the efficacy of a nurse home visit program, an intervention adapted from those studied in other populations (i.e., adults, high-risk infants) and re-engineered through Aim 2, in improving pediatric patient transitions from hospital to home
16110933|NCT02081846|Other|Standard of Care|Control patients will be randomized to receive standard-of-care at discharge. This care at our institution includes pediatric hospitalist to PCP (primary care physician) verbal and written communication prior to discharge, written documentation for the family regarding prescribed medication regimen, recommended follow-up with outpatient PCP and relevant consultant(s), and delivery of prescribed medications from the hospital pharmacy to the patient's bedside.
16110934|NCT02081794|Other|Tailored education intervention|Receive 2 minute video-assisted intervention on the risk and prevention of falls with tailored hand-outs depending on participant answers about fall risks
16110935|NCT02081794|Other|Standard fall care|Patient are given a generic handout on falling and receive standard care by nurses comprising of a fall risk assessment and verbal education
16110936|NCT02081781|Procedure|Probing|"A punctal dilator was used for dilating the punctum. The nasolacrimal system was irrigated through either the lower or upper punctum with a hollow 23-gauge irrigating cannula attached to a syringe. A #0 (or #00) Bowman probe was passed through either the lower or upper canaliculus into the lacrimal sac and then directed downward through the nasolacrimal duct into nasal cavity. A Hard resistance could be felt as the probe touched the end of the nasolacrimal duct. A Pop tactile sensation might be noted while the probe passing through an obstruction at the valve of Hasner."
16110937|NCT02081768|Radiation|90yttrium colloid|90yttrium colloid will be inserted into a sellar/parasellar cyst
16110938|NCT02081755|Drug|Everolimus|Everolimus Dosing: 1.5 mg BID (3.0 mg/day) for 12 months
16110939|NCT02081755|Drug|Tacrolimus|Tacrolimus Dosing: 0.05 mg/kg BID for 12 months
16110940|NCT02081755|Drug|Myfortic|Myfortic®: 360 mg to 1080 mg BID for 12 months
16110941|NCT02081755|Drug|CellCept|CellCept: 500 mg to 1500 mg BID for 12 months
16110943|NCT02081703|Drug|AYX1 Injection 660 mg / 6 mL|6 mL solution for intrathecal injection with 660 mg of AYX1
16110944|NCT02081703|Drug|AYX1 Injection 1100 mg / 10 mL|10 mL solution for intrathecal injection with 1100 mg of AYX1
16110945|NCT02081703|Drug|Placebo Injection 6 mL|6 mL solution for intrathecal injection; Vehicle formulation designed to mimic AYX1 Injection (with no active drug)
16110946|NCT02081703|Drug|Placebo Injection 10 mL|10 mL solution for intrathecal injection; Vehicle formulation designed to mimic AYX1 Injection (with no active drug)
16110947|NCT02081690|Drug|Macitentan|Macitentan tablet, dose of 10 mg, once daily
16110948|NCT02081677|Device|ACUVUE 2|worn in a daily wear modality; lenses will be replaced after 2 weeks
16110949|NCT02081677|Device|Prototype E1|worn in a daily wear modality; lenses will be replaced after 2 weeks
16110950|NCT02081677|Device|Prototype E2|worn in a daily wear modality; lenses will be replaced after 2 weeks
16110951|NCT02081677|Device|Prototype E3|worn in a daily wear modality; lenses will be replaced after 2 weeks
16110952|NCT02081664|Behavioral|lifestyle intervention|
16110953|NCT02081651|Dietary Supplement|Parmigiano Reggiano cheese|
16110954|NCT02081638|Drug|Aspirin|Daily Asprin daily
16110955|NCT02081638|Drug|Atorvastatin|Daily Atorvastatin Daily
16110956|NCT02081625|Drug|NS-065/NCNP-01|"NS-065/NCNP-01 for Infusion is packaged as 25 mg/mL in phosphate buffered saline with 1 mL per vial. Study dosages will be infused over a 1 hour period with Normal saline as follows:
~Cohort 1: 1.25mg/kg once weekly for 12 weeks; Cohort 2: 5.0mg/kg once weekly for 12 weeks; Cohort 3: 20.0mg/kg once weekly for 12 weeks"
16110957|NCT02081612|Behavioral|Nutrition Education|12 educational weight management group session each addressing a different weight loss topic
16110958|NCT02081612|Procedure|Acupuncture|12 weight loss acupuncture session using both body and auricular points.
16110959|NCT02081599|Drug|Teneli (Teneligliptin)|
16110960|NCT02081599|Drug|Placebo|
16110961|NCT02081599|Drug|Insulin|
16110962|NCT02081586|Behavioral|CBT|Therapists will work with patients to identify non-constructive thinking patterns that are serving as barriers to adequate self-management of Type 2 Diabetes.
16110963|NCT02081586|Device|Smartphone app|Smartphone app developed to assist patients practice CBT skills throughout the week
16110964|NCT02081586|Other|Standard Diabetes Care at PCP|Patients receive ADA standard of Care with physician at PCP office
16110965|NCT02081573|Behavioral|Brief CBT|During the course of the twice/month diabetes management phone sessions the nurse care manager will work collaboratively with the patient to identify a dysfunctional belief that may be affecting adherence and could be improved by a brief CBT intervention (5-7 minutes). The care manager will utilize the CBT phone app to identify a CBT intervention that will be most appropriate for the situation. Each intervention is described step by step in the app. The nurse will go through the intervention and when completed will assure the patient's understanding.CBT interventions are geared towards helping the patient identify and restructure thinking that is impairing successful self-management of a chronic disease
16110966|NCT02081560|Drug|Colistin|Colistin i.v. three times daily as long a necessary for infection treatment
16110967|NCT02081534|Drug|AZD1722|AZD1722, oral tablet
16110968|NCT02081534|Drug|Placebo|Placebo bid, double dummy technique
16110969|NCT02081521|Behavioral|Community behaviour change campaign|Community campaign targeting exclusive breastfeeding, handwashing with soap, and use of ORS and zinc to manage child diarrhoea. Includes a range of activities within the community (large events and small group sessions); clinic activities (ORS preparation), radio adverts.
16110970|NCT02081508|Behavioral|Interference onset|Temporal duration of interference onset.
16110971|NCT02081495|Drug|DOXIL/CAELYX reference product (Treatment A)|Participants will receive DOXIL/CAELYX reference product 50 mg/m2 as an intravenous (into a vein) infusion over 90 minutes on Day 1.
16110972|NCT02081495|Drug|DOXIL/CAELYX test product (Treatment B)|Participants will receive DOXIL/CAELYX test product 50 mg/m2 as an intravenous infusion over 90 minutes on Day 1.
16110973|NCT02081482|Radiation|18F-FDG PET|
16110974|NCT02081469|Other|TDF|To compare extend TDF 24 wks versus 48 wks prophylaxis efficacy in chemotherapy CHB patients
16110975|NCT02081456|Other|Soft Tissue Mobilization|Patients in the STM group received treatment in supine, with their head resting on one pillow and the involved UE positioned in abduction and external rotation to preload the neural structures of the upper limb. Manual pressure was applied to the soft tissues of the upper quadrant in a deep, stroking manner with the intention to improve the mobility of the soft tissues surrounding the pathway of the neural structures of the upper limb as well as any tender or tight tissues. The therapist spent approximately 7 minutes on the neck and scapular region, 4 minutes on the upper arm, and 4 minutes on the forearm and hand. The therapist was allowed to vary the time spent on each region according to his/her assessment of the patient's condition. The procedure lasted a total of 15 minutes.
16110976|NCT02081456|Device|Therapeutic Ultrasound|Patients received therapeutic US applied for a period of 5 minutes to the most painful region of the neck, then a second 5-minute dose at the most painful region of the upper extremity. The US dose was 0.5 w/cm2, with sonation time 50% and frequency 1 MHz.40,52 The patient lay supine with the hand of the involved upper extremity placed on the abdomen and the elbow supported on a pillow. The two US doses and interaction time with the patient lasted a total of 15 minutes in an attempt to have equal patient/therapist contact between the two groups.
16110977|NCT02081443|Drug|Ticagrelor 180mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
16110978|NCT02081443|Drug|Ticagrelor 90mg|The proposed study will have a prospective, randomized, parallel design in which patients on chronic ticagrelor therapy will be assigned to receive a reloading dose of 90 or 180 mg ticagrelor. Platelet function assays will be done following in vitro incubation with and without 500 nM cangrelor.
16110979|NCT02081430|Procedure|CT Manipulation|
16110980|NCT02081430|Procedure|Upper trapezius stretch|
16110981|NCT02081417|Behavioral|Seeking Safety|SS is a present-focused clinical intervention designed to target trauma/PTSD and SUDs.
16110982|NCT02081404|Drug|Esomeprazole|standard dose of proton pump inhibitor by mouth once a day for 30 days
16110983|NCT02081404|Drug|Placebo|placebo
16110984|NCT02081391|Drug|Tapentadol oral solution 4 mg/mL|"Participants aged 6 months to less than 18 years old with a body weight below 20 kg received tapentadol oral solution 4 mg/mL by mouth every 4 hours for up to 72 hours.
~Participants from birth to less than 6 months received tapentadol oral solution, diluted 4 fold."
16110985|NCT02081391|Drug|Tapentadol oral solution 20 mg/mL|Participants aged from 6 months to less than 18 years with a body weight greater than or equal to 20 kg received tapentadol oral solution 20 mg/mL by mouth every 4 hours for up to 72 hours.
16110986|NCT02081391|Other|Placebo|Matching placebo oral solution was administered by mouth every 4 hours up to 72 hours.
16110992|NCT02081365|Behavioral|Computerized Dental Anxiety Treatment|The Computerized Dental Anxiety Treatment Program consists of treatment modules that are be delivered through a computer. The modules use Cognitive Behavioral Therapy (CBT) to assist the participant in preparing a personal plan for managing his/her dental anxiety. The program incorporates a range of CBT techniques, including cognitive restructuring, exposure, and motivational interviewing.
16110993|NCT02081352|Other|DermaPure™|"A minimally manipulated human tissue regulated as human cells, tissues, and cellular and tissue-based products (HCT/Ps)"
16110994|NCT02081352|Other|Standard care|
16110995|NCT02081339|Drug|ranibizumab, aflibercept, pegaptanib, verteporphin|
16110996|NCT02081326|Biological|Bacillus Calmette-Guérin|2 BCG vaccinations spaced 4 weeks apart during the first year and then 1 vaccination every year for the next 4 years
16110997|NCT02081326|Biological|Saline injection|2 injections spaced 4 weeks apart during the first year, then 1 injection per year for the next 4 years
16110998|NCT02081313|Other|Biopsy|
16110999|NCT02081313|Other|Blood sample|
16111000|NCT02081300|Drug|Oral testosterone undecanoate, LPCN 1021|
16111001|NCT02081300|Drug|Topical testosterone gel 1.62 %|
16111002|NCT02081287|Drug|IP6|IP6 2,000 -3,000 mg per day given orally in two doses
16111003|NCT02081287|Drug|Lamotrigine|Dose up to 200 mg per day over 10 weeks
16111004|NCT02081274|Procedure|Surgery for congenital heart disease|
16111005|NCT02081261|Procedure|Coronary artery bypass surgery|coronary artery bypass surgery
16111006|NCT02081248|Other|Consent Form Specific Format 1|The Consent Form Specific Format 1 is the 'Standard Consent'. The standard consent does not have the format of two-columns with changes in layout readability, organization of content, typography and use of plain language. Standard consents are already used by sites for the BMT CTN 0901, 1101, 1203, and 1301 clinical trials.
16111007|NCT02081248|Other|Consent Form Specific Format 2|The Consent Form Specific Format 2 is the 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent is two-columns with changes in layout readability, organization of content, typography and use of plain language.
16111008|NCT02081235|Procedure|surgery for congenital heart disease|surgery for congenital heart disease
16111009|NCT02081222|Procedure|surgery for congenital heart disease with cardiopulmonary bypass|surgery for congenital heart disease with cardiopulmonary bypass
16111010|NCT02081209|Device|The Zeltiq System|Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
16111011|NCT02081196|Device|The Zeltiq CoolSculpting System|Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
16111012|NCT02081183|Drug|Mycophenolate mofetil (MMF)|1 g/day, PO BID for 2 weeks; 1.5 g/day PO TID for the next 2 weeks; and 2 g/day PO BID for the remainder of the Maintenance Phase.
16111013|NCT02081183|Drug|Cyclophosphamide, Maintenance Phase|0.5-1 g/m^2 IV pulse once every 3 months
16111014|NCT02081183|Drug|Cyclophosphamide, Induction Phase|0.5 - 1 g/m^2 IV pulse once per month
16111015|NCT02081183|Drug|Prednisone|1 mg/kg PO once per day; reduced by 5 mg every 2 weeks up to 20 mg/day; followed by a reduction of 2.5 mg every 2 weeks until reaching the maintenance phase of 10 mg/day.
16111016|NCT02081170|Procedure|Autologous platelet concentrate|"pars plana vitrectomy
~internal limiting membrane removal
~Fluid-air exchange
~Intravitreal autologous platelet concentrate injection
~Intravitreal gas (14% C3F8) injection
~Keep prone position for 7-14 days after surgery"
16111017|NCT02081157|Device|GalaFlex Mesh|
16111018|NCT02081144|Other|Smokefree TXT Program|The SmokeFreeTxt program is a library consisting of ~130 brief messages that can be proactively sent to smokers' cellphones using software developed and maintained by NCI. The message content is informed by principles of cognitive behavioral therapy. They are sent to smokers at random times of day (during normal waking hours), up to 5 messages per day.
16111019|NCT02081144|Drug|nicotine replacement patches|Subject will be given 4 weeks of Nicotine Replacement Patches, based on the amount he/she is smoking at baseline.
16111020|NCT02081144|Drug|Nicotine Replacement Gum|Subjects will be given 10 pieces of 2mg Nicotine Replacement Gum x 28 days.
16111021|NCT02081144|Behavioral|Faxed Referral CT Smokers Quitline|A faxed referral will be sent to the CT Smokers Quitline for the subject.
16111022|NCT02081131|Procedure|Open surgery|pancreatic head resection by open method
16111023|NCT02081131|Procedure|Laparoscopic surgery|laparoscopic pancreatoduodenectomy
16111024|NCT02081118|Drug|HM11260C|HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)
16111025|NCT02081118|Drug|Placebo|Placebo for HM11260C
16111026|NCT02081105|Other|PEEP of 5 or 15 cm H2O|PEEP of 5 or 15 cm H2O set at the respirator and applied to the patient for 10 minutes. Then, measurements are made at each PEEP in the following order: arterial blood gas, CXR, pressure-volume curve.
16111027|NCT02081079|Drug|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet administered orally once daily
16111028|NCT02081066|Other|cardiovascular risk factors|
16111029|NCT02081053|Device|STAR™ Tumor Ablation System and StabiliT® Vertebral Augmentation System|Radiofrequency targeted radiofrequency ablation (t-RFA) and targeted vertebral augmentation (RF-TVA)
16111030|NCT02081040|Other|Not applicable (observational study with no active intervention)|
16111033|NCT02081014|Drug|G-Pen Mini™ (glucagon injection)|stable, pre-mixed, liquid glucagon for subcutaneous injection
16111034|NCT02081001|Drug|Novo Nordisk GlucaGen®|single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg
16111035|NCT02081001|Drug|G-Pump™ (glucagon infusion)|single subcutaneous infusion doses at 0.3 μg/kg, 1.2 μg/kg and 2.0 μg/kg
16111036|NCT02080975|Other|Data Collection During Atrial Flutter Ablation|All enrolled patients are clinically indicated for an atrial flutter ablation. The patients who consent for this study will have additional electrocardiograms taken during their procedure for future review, as well as ultrasound images form inside their heart. This will lengthen the ablation by approximately 10 minutes, but is not a separate procedure.
16111037|NCT02080962|Radiation|30 Gy in 5 fractions|5 fractions of 600 cGy, once a day, five times a week - TDF: 89
16111038|NCT02080962|Radiation|40 Gy in 10 fractions|tumors > 2-5 cm in diameter: 10 fractions of 400 cGy, once a day, five times a week - TDF: 96
16111039|NCT02080949|Radiation|4fx x 5Gy|It'll be recruited 3 patients to the initial scheme of 4 fractions of 5 Gy on each brain metastasis with HSRT and if no patient has unacceptable toxicity, more 3 patients for subsequent scheme will be recruited. If 2 patients had unacceptable toxicity, the study ends and it'll be considered the study initiated with toxic regimen. If 1 patient has unacceptable toxicity, it'll be recruited 3 more patients for this scheme and if 1 or more patients had unacceptable toxicity, the scheme will be considered toxic and the study will be closed. If no patient develops unacceptable toxicity, the study will follow to the next cohort of 3 more patients with next dose level. The same criteria of recruitment will be performed till any scheme reach the MTD or up to the scheme of 4 fractions of 9 Gy.
16111040|NCT02080923|Behavioral|Brief Motivational Interview|The intervention is exclusively focused on Adolescent Dating Aggression and will always be delivered by a human interventionist. It is theory-based and its success as an intervention method for substance abuse and several other health-related issues is well established.
16111041|NCT02080910|Behavioral|Psychoeducation|
16111042|NCT02080871|Device|Stenting of the Common and/or External Iliac Arteries|Balloon expandable stenting of iliac occlusive disease.
16111043|NCT02080858|Drug|Ticagrelor + Apixaban + ASA|
16111044|NCT02080858|Drug|Ticagrelor + Apixaban|
16111045|NCT02080845|Dietary Supplement|no caffeine|
16111046|NCT02080845|Dietary Supplement|high caffeine|
16111047|NCT02080845|Dietary Supplement|no theobromine|
16111048|NCT02080845|Dietary Supplement|low theobromine|
16111049|NCT02080845|Dietary Supplement|high theobromine|
16111050|NCT02080832|Drug|Citalopram|20 mg or 40 mg daily for 8 weeks
16111051|NCT02080832|Drug|Placebo|Placebo daily for 8 weeks
16111052|NCT02080819|Drug|levodopa/carbidopa 400/100 BID|"Levodopa dose escalation (1 week): Days 1-2, one 50/12.5 mg tablet BID; Days 3-4, one 100/25 mg tablet BID; Days 5-6, one 200/50 mg tablet BID; Day 7, one 400/100 mg tablet BID.
~Maintenance phase (7 weeks): One 400/100 mg Levodopa/Carbidopa tablet BID or placebo in conjunction with once weekly individual cognitive behavioral therapy plus contingency management for attendance."
16111053|NCT02080806|Device|Mechanical Insufflation Exsufflation|Mechanical Insufflation Exsufflation -Each patient received daily treatments by means of a light-weight, elastic oronasal mask. Treatments were divided between morning and afternoon and were carried out 5 times a week. A total of 20 sessions were carried out by a a trained respiratory therapist.
16111054|NCT02080793|Other|Questionnaire|
16111055|NCT02080780|Drug|Clarithromycin XL|Clarithromycin XL administered once daily on Days 4 through 9 as 2 x 500 mg tablets, 1000 mg per day, for a total of 6000 mg
16111056|NCT02080780|Drug|2% Diltiazem|2% Diltiazem Hydrochloride Cream applied on Day 1 & Day 8 to the perianal area (~2.5 cm [1 inch]; ~8.5 mg)
16111057|NCT02080767|Drug|Tecovirimat|Oral tablet 600mg daily dose(three capsules, 200 mg/capsule)
16111058|NCT02080754|Other|effective sellick maneuver|Sellick maneuver is applied, as originally described by Sellick et al .
16111059|NCT02080754|Other|sham sellick maneuver|The operator who applied the maneuver is the only person who knows the arm inclusion of the patient. Thus, he sets his fingers as described in Sellick arms without exerting pressure on the cricoid cartilage.
16111060|NCT02080741|Other|Blood sample of 12 ml|
16111061|NCT02080728|Drug|Ropivacaine 500mg/100ml Naropeine|
16111062|NCT02080728|Drug|0.9% sodium chloride BAXTER|
16111063|NCT02080715|Drug|Tolcapone|2 x 100mg Tolcapone compared to placebo (randomized, double-blind, cross-over)
16111064|NCT02080715|Drug|Placebo|
16111065|NCT02080702|Device|Monosyn|Monosyn will be used to perform the gastrointestinal anastomoses
16111066|NCT02080689|Other|Decipher|
16111067|NCT02080663|Procedure|Proximal row carpectomy|
16111068|NCT02080650|Device|Mesenchymal-marker based ferrofluid (c-MET)|
16111069|NCT02080650|Device|Epithelial cell adhesion molecule (EpCAM) ferrofluid|
16111070|NCT02080637|Drug|Ambrisentan|Once daily oral dosing
16111071|NCT02080637|Other|Placebo|
16111072|NCT02080624|Drug|Drug: Topical Rapamycin|"After signing this consent form, you will be asked to undergo some screening tests or procedures to find out if you can be in the research study.
~A medical history, which involves questions about your health history, any medications you are taking or plan to take, any allergies and the treatments you received for your CM.
~A physical exam, during which you will be asked about any problems that you might be having. Additionally, your clinician will check your vital signs (blood pressure, heart rate, weight and height). The doctor will also evaluate your performance status, which indicates how much your illness affects your activity level.
~Blood tests, which will be done to make sure your hemogram, triglyceride and cholesterol levels are normal.
~A pregnancy test for females will be done to check that you are not pregnant. If theses tests show that you are eligible to participate in the research study, you will begin the study treatment."
16111073|NCT02080598|Behavioral|2 cigarettes in 15 minutes|
16111074|NCT02080585|Behavioral|Physical Activity advice.|Subjects receive advice regarding physical activities.
16111075|NCT02080559|Biological|4CMenB|0.5ml IM
16111076|NCT02080546|Procedure|Cut-Coag|"Incision using electrothermal cautery, with an attempt made to use the cut (continuous low-voltage, high-current) for colpotomy incision following the initial scoring of the cervico-vaginal tissue on the coag (pulsed high-voltage, low-current) mode."
16112432|NCT02070458|Drug|ixazomib|Given PO
16111077|NCT02080546|Procedure|V-mode|"Incision using electrothermal cautery in the V mode. The V mode combines real-time tissue sensing technology with the cut and coag waveforms to reduce the amount of thermal spread to the tissue without sacrificing hemostasis during monopolar electrothermal procedures."
16111078|NCT02080546|Device|Valleylab G3000 Electrosurgical Device|Use of surgical device Valleylab G3000 Electrosurgical Device
16111079|NCT02080533|Other|Slow-paced respiration therapy|The FDA-approved RESPeRATE device contains headphones and a sensor that attaches to the chest to detect inhalation and exhalation. Musical tones synchronize with the respiratory cycle to slowly guide the user to decrease respirations.
16111080|NCT02080520|Dietary Supplement|Nattokinase|
16111081|NCT02080520|Dietary Supplement|Placebo|
16111082|NCT02080507|Device|Active Neuronetics rTMS stimulator|In the active group, magnetic power output will be delivered to the subject through the coils.
16111083|NCT02080507|Device|Inactive Neuronetics rTMS stimulator|In the inactive group, no magnetic power output will be delivered to the subject through the coils.
16111084|NCT02080494|Drug|Tranexamic Acid|
16111085|NCT02080481|Device|Infiniti Plus needle guidance system|The Infiniti Plus needle guidance system is designed to help physicians perform ultrasound guided nerve blocks.
16111086|NCT02080481|Device|Conventional block needle|conventional block needle used for insertion of femoral nerve catheters.
16111087|NCT02080468|Drug|lomitapide|20 mg
16111088|NCT02080468|Drug|EE/norgestimate|1x0.035-mg EE/0.25-mg norgestimate tablet
16111089|NCT02080455|Drug|lomitapide|20 mg dose
16111090|NCT02080455|Drug|Atorvastatin|80 mg
16111091|NCT02080442|Other|Balance training|Training will consist of 30 minute sessions 2-3 times/week for a total of 18-24 sessions, in keeping with best practice guidelines for older adults.12 Sessions will be supervised by physical therapists, using a circuit training approach with different stations designed to target specific areas of impairment. Participants will work through stations in a group setting; however, will receive individualized exercise prescription regarding level of difficulty and exercise progression.
16111092|NCT02080429|Procedure|Passive Descent|
16111093|NCT02080429|Procedure|Pushing|
16111094|NCT02080416|Drug|Nelfinavir|Nelfinavir will be given 3000 mg orally twice daily on days 1-14 of a 14-day cycle. NFV will be continued in patients tolerating therapy for 4 cycles (8 weeks).
16111095|NCT02080403|Drug|2.5 mg Chlorhexidine gluconate chip|Subgingival debridement will be carried out for each one of the target implant. Upon completion of the debridement a PerioChip® will be inserted in each one of the target implant.
16111096|NCT02080390|Procedure|Transthoracic echocardiogram (ultrasound)|Any transthoracic echocardiogram (ultrasound) of the heart, performed as part of standard clinical care, will be further evaluated for special parameters that may help to detect weakening.
16111097|NCT02080377|Drug|Glibenclamide|
16111098|NCT02080377|Drug|Insulin|
16111099|NCT02080364|Drug|Azeliragon|Azeliragon 5mg administered orally, once daily for 18 months
16111100|NCT02080364|Drug|Placebo|Placebo administered orally, once daily for 18 months
16111101|NCT02080351|Behavioral|Simple cognitive task|
16111102|NCT02080338|Device|Orthodontic bracket slot system|Orthodontic treatment using different orthodontic bracket slot systems
16111103|NCT02080325|Other|High Protein-Weight loss-Soy diet|• The high protein (HP) weight loss diet will be fed to 100% resting metabolic rate (RMR) on a 5 day rotation menu, fed as three meals a day, 30% protein, 30% fat and 40% carbohydrate; the soya version based on soya protein or soya-tvp (textured vegetable protein).
16111104|NCT02080325|Other|High Protein-Weight loss-Meat|• The high protein (HP) weight loss diet will be fed to 100% resting metabolic rate (RMR) on a 5 day rotation menu, fed as three meals a day, 30% protein, 30% fat and 40% carbohydrate; the meat version will be based on chicken and beef meat.
16111105|NCT02080312|Drug|Magnevist (gadopentetate dimeglumine)|
16111106|NCT02080299|Procedure|Remote ischemic preconditioning (RIPC)|3 circles of 5 min left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 min reperfusion, preceding TAVI procedure.
16111107|NCT02080299|Procedure|Placebo|Prior to TAVI-procedure, the blood pressure cuff remains uninflated for 30 min.
16111108|NCT02080286|Behavioral|Prism Adaptation|All participants will undergo prism adaptation, a form of behavioural therapy involving reaching and pointing movements while wearing glasses that induce an optical shift.
16111109|NCT02080286|Device|Anodal tDCS|"Participants will receive 1mA anodal tDCS over the left primary motor cortex. The active (positive) electrode will be centered on the scalp overlying the primary motor cortex and the reference (negative) electrode will be placed over the contralateral supraorbital ridge.
~The stimulation will last 20 minutes and run concurrent with the duration of the prism adaptation therapy."
16111110|NCT02080286|Device|Sham tDCS|"Participants will receive 1mA sham tDCS over the left primary motor cortex. The active (positive) electrode will be centered on the scalp overlying the primary motor cortex and the reference (negative) electrode will be placed over the contralateral supraorbital ridge.
~The stimulation will last 20 minutes and run concurrent with the duration of the prism adaptation therapy."
16111111|NCT02080273|Drug|Colgate Cavity Protection toothpaste|0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment.
16111112|NCT02080273|Drug|Colgate Total toothpaste|0.32% sodium fluoride (1450 ppm NaF) and 0.3% triclosan. Colgate Total toothpaste is the active comparator toothpaste
16111113|NCT02080273|Drug|Parodontax toothpaste|1400 ppm sodium fluoride (NaF), Parodontax toothpaste is the active comparator toothpaste
16111114|NCT02080260|Drug|regorafenib|Single agent drug therapy with regorafenib
16111115|NCT02080247|Drug|Skin care regimen with Calmoseptine ointment|Application of Calmoseptine Ointment for 6 days will be applied on the affected area that will be calculated by multiplying the longest portion of the affected area measured in a head to toe orientation by the widest portion of the affected area measured from side to side(in Centimeters).
16111116|NCT02080247|Drug|Skin care regimen with Destin ointment|Application of Destin for 6 days will be applied on the affected area that will be calculated by multiplying the longest portion of the affected area measured in a head to toe orientation by the widest portion of the affected area measured from side to side(in Centimeters). Patients will receive treatment with Destin Maximum Strength 40% Zinc Oxide Diaper Rash Paste (Destin) for 6 days as part of a structured skin care regimen.
16111117|NCT02080234|Drug|GELOX|gemcitabine ：1250mg/m2 (ivdrip) on days 1, oxaliplatin :85 mg/m2 (ivdrip) on day 1, and pegaspargase : 2500 IU/m2 (intramuscular injection) on day 1.Cycle is repeated every 14 days
16111118|NCT02080234|Radiation|IFRT|IFRT is delivered using 6-MeV linear accelerator using 3-dimensional conformable treatment planning. The IFRT dose was 56 grays (Gy) in 28 fractions
16111119|NCT02080221|Drug|FOLFOXA|
16111120|NCT02080208|Device|Optiflow|patients receive oxygen via high flow oxygen therapy during 20 minutes
16111121|NCT02080195|Drug|Cyclophosphamide|14.5 mg/kg/day on Days -6 and -5. 50 mg/kg/day on Days 3 and 4.
16111122|NCT02080195|Drug|Fludarabine|30 mg/m^2/day on Days -6 through -2.
16111123|NCT02080195|Drug|Tacrolimus|Starting on Day 5. Dose will be adjusted according to blood levels.
16111124|NCT02080195|Drug|Mycophenolate Mofetil|15 mg/kg three times per day from Day 5 to Day 35.
16111125|NCT02080195|Drug|Rabbit antithymocyte globulin|0.5 mg/kg on Day -9. 2 mg/kg/day on Days -8 and -7.
16111126|NCT02080195|Radiation|Total body irradiation|200 centigray on Day -1.
16111127|NCT02080195|Biological|Allogeneic bone marrow transplant|Infusion on Day 0.
16111128|NCT02080182|Drug|Acetylcysteine|
16111129|NCT02080182|Drug|placebo acetylcysteine|
16111130|NCT02080169|Drug|midazolam|"If the target sedation level is not obtained using the above recommended dosage, midazolam 0.01-0.05 mg/kg is added every 10-15min, until the target sedation level is obtained.
~If it is over sedation (RASS -3 to -5), and reduction of the dosage of the sedation drug could not ease the situation, and then stop the sedation until the target sedation level is obtained."
16111131|NCT02080169|Drug|Dexmedetomidine|"If the target sedation level is not obtained using the above recommended dosage, midazolam 0.01-0.05 mg/kg is added every 10-15min, until the target sedation level is obtained.
~If it is over sedation (RASS -3 to -5), and reduction of the dosage of the sedation drug could not ease the situation, and then stop the sedation until the target sedation level is obtained."
16111132|NCT02080169|Drug|Fentanyl|Fentanyl is used as analgesic drug in order to obtain the VAS <3.
16111133|NCT02080156|Device|CPAP|
16111134|NCT02080143|Device|Thermal Adhesion Patch|
16111135|NCT02080143|Device|Thermal Adhesion Patch|
16111136|NCT02080130|Dietary Supplement|Saccharomyces boulardii|FLORATIL®. Saccharomyces boulardii 200 mg sachet. One sachet orally, BID, for 5 days.
16111137|NCT02080130|Dietary Supplement|Probiotics combination|LACTIPAN®. Probiotics combination sachet. One sachet orally, BID, for 5 days. Lactobacillus acidophilus............. 1.00 x 109 cfu Lactobacillus casei........................ 1.00 x 109 cfu Lactobacillus rhamnosus............. 4.40 x 108 cfu Lactobacillus plantarum............... 1.76 x 108 cfu Bifidobacterium infantis................ 2.76 x 107 cfu Streptococcus thermophillus....... 6.66 x 105 cfu
16111138|NCT02080130|Other|Placebo|Placebo
16111139|NCT02080117|Procedure|kidney transplantation, living or deceased donor|
16111140|NCT02080104|Drug|intarvenous and intramusculer 10 IU oxytocin|intarvenous and intramusculer 10 IU oxytocin
16111141|NCT02080078|Drug|Theophylline|
16111142|NCT02080078|Drug|Erlotinib|
16111143|NCT02080065|Procedure|living donor liver transplantation|
16111144|NCT02080052|Device|Robot-assisted prostate biopsy|
16111145|NCT02080039|Device|Electrical Stimulation|
16111146|NCT02080026|Biological|CPS-immunization|Subjects will receive four 'immunizations' with bites from 15 Plasmodium infected mosquitoes during each immunization, while taking chloroquine prophylaxis.
16111147|NCT02080026|Biological|Controlled Human Malaria Infection|Subjects will receive bites from 5 Anopheles mosquitoes infected with Plasmodium falciparum, NF54 strain.
16111148|NCT02080026|Drug|chloroquine|Registered for prophylaxis against infection with Plasmodium falciparum and the treatment of acute infections.
16111149|NCT02080026|Drug|atovaquone/proguanil|"Registered for use as an antimalarial agent for the treatment of acute infections with Plasmodium falciparum.
~One tablet contains: atovaquone 250 mg, proguanil(hydrochloride) 100 mg"
16111150|NCT02080013|Other|radiofrequency|ClosureFAST
16111151|NCT02080000|Other|Optimisation of V-V timing using R wave on surface ECG|
16111152|NCT02080000|Other|Standard V-V timing settings|
16111153|NCT02079987|Behavioral|ED-to-home care transition intervention|The Area Agency on Aging coach's role is to build self-management capabilities for the patient and their caregiver. During each contact, the coach reviews the four components of the Care Transition Intervention: 1: Follow-up Medical Visit. 2: Knowledge of Red Flag Symptoms. 3: Medication Reconciliation. 4: The Personal Health Record (PHR). The coach assists patients use the PHR to document and maintain vital information and to communicate with providers.
16111154|NCT02079987|Other|Usual Care|Patients randomized to usual care will receive verbal and written discharge instructions from the treating ED physician and nurse as is the standard of care.
16111155|NCT02079974|Drug|Pravastatin|20 mg pravastatin sodium daily for 3 months
16111156|NCT02079961|Dietary Supplement|Micronutrient-fortified yoghurt|A iron-fortified yogurt targeted to children 24-59 months old will be provided through the logistics of an existing value chain, to see if in return this can enhance the reliability of producers supply within this value chain.
16111157|NCT02079961|Behavioral|BCC|"Behavior Change Campaign (BCC)
~A behavior change campaign will be conducted during all the duration of the intervention to increase knowledge about good infant feeding practices and health."
16111158|NCT02079948|Drug|Methotrexate + Folic Acid|"Participants in the methotrexate + folic acid condition will have a
~Blood draw at each monthly visit
~Cognitive performance testing to assess memory performance
~Physical function testing to assess walking speed and measure muscle endurance
~Pain assessment testing to assess the presence and location of daily pain
~Self-reported function and quality of life to measure disability and mobility limitations, and
~Depression assessment testing to assess participants' level of depression."
16111159|NCT02079948|Drug|Placebo + Folic Acid|"Participants in the placebo + folic acid condition will have a
~Blood draw at each monthly visit
~Cognitive performance testing to assess memory performance
~Physical function testing to assess walking speed and measure muscle endurance
~Pain assessment testing to assess the presence and location of daily pain
~Self-reported function and quality of life to measure disability and mobility limitations, and
~Depression assessment testing to assess participants' level of depression"
16111243|NCT02079545|Drug|Sirukumab (SC injection with PFS-U)|Participants will receive a single SC injection of 50 mg sirukumab with PFS-U.
16111160|NCT02079948|Procedure|Functional MRI Experimental Tasks|Participants who are randomly assigned to the fMRI scan wil receive their study drugs at the the Baseline fMRI visit. Participants who are randomly assigned to the fMRI will also attend complete their last visit at the 6 month period.
16111161|NCT02079948|Procedure|Muscle Biopsy|Participants who are randomly assigned to the muscle biopsy assessment of the study will receive their study drugs at the Baseline muscle biopsy visit. Participants who are randomly assigned to the muscle biopsy portion of the study will also complete their last visit at the 6 month period.
16111162|NCT02079935|Behavioral|Cognitive Behaviour Therapy|Following group-modified protocol for cognitive behavioral therapy, CBT, first described by Fairburn 2008, modified by Modum Bad, Norway.
16111163|NCT02079935|Behavioral|Physical Activity and Dietary Therapy|Guided physical activity and dietary therapy, to (re-)introduce a more healthy lifestyle and help stabilizing a healthy weight. A detailed manual will be published.
16111164|NCT02079922|Drug|PF-06678552|PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
16111165|NCT02079922|Drug|Placebo|PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
16111166|NCT02079922|Drug|PF-06678552|PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
16111167|NCT02079922|Drug|Placebo|PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
16111168|NCT02079922|Drug|PF-06678552|PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
16111169|NCT02079922|Drug|Placebo|PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
16111170|NCT02079922|Drug|PF-06678552|PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
16111171|NCT02079922|Drug|Placebo|PF-06678552 or placebo will be administered as an extemporaneously prepared solution every 12 hours for 14 days.
16111172|NCT02079922|Drug|PF-06678552|PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
16111173|NCT02079922|Drug|Placebo|PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
16111174|NCT02079922|Drug|PF-06678552|PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
16111175|NCT02079922|Drug|Placebo|PF-06678552 or placebo will be administered as an extemporaneously prepared solution either once daily (QD), every 12 hours (Q12H), or every 8 hours (Q8H) for 14 days.
16111176|NCT02079909|Drug|T-817MA-H|224 mg or 448 mg T-817 MA once daily
16111177|NCT02079909|Drug|T-817MA-L|224 mg T-817 MA once daily
16111178|NCT02079909|Drug|Placebo|Placebo
16111179|NCT02079896|Drug|Lexaptepid pegol (NOX-H94)|anti-hepcidin L-RNA-aptamer (Spiegelmer)
16111180|NCT02079896|Drug|Placebo|
16111181|NCT02079870|Drug|semaglutide|Solution for subcutaneous (s.c. - under the skin) injection. 0.25 mg semaglutide once weekly for four weeks, 0.5 mg semaglutide once weekly for four weeks followed by 1.0 mg semaglutide once weekly for five weeks
16111182|NCT02079870|Drug|placebo|Solution for subcutaneous (s.c. - under the skin) injection
16111183|NCT02079857|Other|Standard protocol|Subjects will receive a standard treatment
16111184|NCT02079857|Other|Individualized protocol|Subjects will receive an individualized treatment
16111185|NCT02079857|Other|Sham acupuncture/Placebo moxa|Subjects will receive sham acupuncture/placebo moxa
16111186|NCT02079844|Drug|Roflumilast|Roflumilast tablets
16111187|NCT02079844|Drug|Placebo|Roflumilast placebo-matching tablets
16111188|NCT02079844|Drug|Second generation antipsychotic|Second Generation Antipsychotic (SGA) medication for standard of care therapy will be sourced and managed locally by the site.
16111189|NCT02079831|Behavioral|Energy Restriction|"Participants will receive an intervention specifically designed for adolescents and their group assignment that relies on nutrition education, nutritional counseling, social cognitive therapy, behavioral strategies, self-monitoring, portion size reduction, and increased physical activity.
~Participants will get an individualized dietary meal plan. Dietary counseling will be based on the MyPlate guidelines with extra attention and focus on appropriate protein food choice. Also in accordance to the MyPlate guidelines, all participants will be instructed to increase physical activity to 60 minutes a day as aerobic physical activity."
16111190|NCT02079831|Behavioral|Higher protein|The higher protein group will be instructed to consume 30% of energy as protein, with 25% and 45% of energy from fat and carbohydrate, respectively.
16111191|NCT02079831|Behavioral|Lower Protein|The lower protein group will be instructed to consume 15% of energy as protein, with 25% and 60% of energy from fat and carbohydrate, respectively.
16111192|NCT02079818|Device|Penumbra Ruby Coil System|The Penumbra Ruby™ Coil is a new generation of detachable coils developed by Penumbra Inc. This coil system is specifically designed for the occlusion of aneurysms and vessels that is equivalent to standard platinum coils. This system consists of: an implantable Coil attached to a Detachment Pusher as well as a Detachment Handle. The Detachment Pusher is comprised of a shaft with a radiopaque positioning marker, a Distal Detachment Tip, and a pull wire. The Detachment Handle is used to detach the Coil Implant from the Detachment Pusher. The Penumbra Ruby Coil is designed for endovascular embolization in the peripheral vasculature. Intended users for this device are physicians who have received appropriate training in interventional radiology and endovascular intervention.
16111193|NCT02079805|Drug|Azilsartan|Azilsartan tablets
16111194|NCT02079805|Drug|Telmisartan|Telmisartan tablets
16111195|NCT02079792|Procedure|Lying Head Back Position|Subjects randomized to the LHB position will be instructed to lay supine on the clinical table, with their head hanging over the edge of the bed as far as possible without discomfort.
16111196|NCT02079792|Procedure|Head Down and Forward Position|Subjects randomized to the HDF position will be instructed to kneel down, placing the top of their head on the ground and forehead close to the knees with the nostrils facing upwards.
16111244|NCT02079545|Drug|Sirukumab (SC injection with PFS-AI)|Participants will receive a single SC injection of 50 mg sirukumab with PFS-AI.
16111197|NCT02079779|Other|Robotic-assisted therapy|The robotic device is designed to intensively rehabilitate the upper limb. Indeed, this robot allows the patient to perform a lot of active, passive, or assisted exercises. The level of assistance is determined and provided by the robot in function of the patient performance (i.e. quality of movements).
16111198|NCT02079779|Other|Classical therapy|Conventional therapy will be performed by therapists specialized in neuro-rehabilitation
16111199|NCT02079766|Drug|florbetapir F 18|370 megabecquerel (MBq) IV single-dose
16111200|NCT02079766|Drug|Flortaucipir F18|370 megabecquerel (MBq) IV single-dose
16111201|NCT02079753|Device|Inogen|single pulse dose concentrator (Inogen One G2 portable. Inogen) device for 24 hours
16111202|NCT02079753|Device|Combination system of a portable and a stationary device.|"Combination system of a portable and a stationary device (reservoir of liquid oxygen Liberator 30, Caire and a liquid Stroller oxygen pack Caire for patients using previously liquid oxygen, or a VisionAire5 Airsep stationary concentrator and an Inogen One G2 portable Inogen concentrator for patients using previously concentrators)"
16111203|NCT02079740|Biological|Navitoclax|Given PO
16111204|NCT02079740|Drug|Trametinib|Given PO
16111205|NCT02079727|Drug|chondroitin sulfate|
16111206|NCT02079727|Drug|celecoxib|
16111207|NCT02079727|Drug|placebo|
16111208|NCT02079701|Biological|23-valent pneumococcal vaccine|randomization, based upon a random-number (block design) double-blind enrollment sequence. 1:1 ratio.
16111209|NCT02079701|Biological|Placebo|
16111210|NCT02079688|Drug|SB011, 2 % (Water/Oil/Water) emulsion of hgd40|"Treatment will be performed BID on 14 consecutive days and one single last application at the site on Day 15 (29 applications in total).
~Two preferably disseminated and contralateral, comparable lesional treatment areas of approximately 50 cm2 each and located on arms, legs, chest, stomach or neck will be chosen. All patients will perform treatment with both formulation SB011 containing 2% hgd40 and the active ingredient-free vehicle. Comparison of the IMPs will be performed intraindividually.
~Approximately 5 mg/cm2 (250 μl) of SB011 (2% hgd40) and the vehicle will be applied to the respective treatment areas. The time between the two applications should include min. 8 hours and max. 16 hours. Patients compliance will be controlled by weighing of the IMPs at each visit. On day 1 the application of the IMPs will be demonstrated to the patients at the clinical site. The first treatment as well as the morning treatment on Days 3, 5, 8, 12, and 15 will be carried out at the clinical site"
16111211|NCT02079688|Drug|Multiple W/O/W formulation, active ingredient-free vehicle|"Treatment will be performed BID on 14 consecutive days and one single last application at the site on Day 15 (29 applications in total).
~Two preferably disseminated and contralateral, comparable lesional treatment areas of approximately 50 cm2 each and located on arms, legs, chest, stomach or neck will be chosen. All patients will perform treatment with both formulation SB011 containing 2% hgd40 and the active ingredient-free vehicle. Comparison of the IMPs will be performed intraindividually.
~Approximately 5 mg/cm2 (250 μl) of SB011 (2% hgd40) and the vehicle will be applied to the respective treatment areas. The time between the two applications should include min. 8 hours and max. 16 hours. Patients compliance will be controlled by weighing of the IMPs at each visit. On day 1 the application of the IMPs will be demonstrated to the patients at the clinical site. The first treatment as well as the morning treatment on Days 3, 5, 8, 12, and 15 will be carried out at the clinical site"
16111212|NCT02079675|Drug|SKI3246 Low Dose|SKI3246 Low Dose will be taken for a 4-week duration (28 days) as 4 capsules a day: two capsules in the morning and two capsule in the evening
16111213|NCT02079675|Drug|SKI3246 High Dose|SKI3246 High Dose will be taken for a 4-week duration (28 days) as 4 capsules a day: two capsules in the morning and two capsule in the evening
16111214|NCT02079675|Drug|Placebo|SKI3246 Placebo will be taken for a 4-week duration (28 days) as 4 capsules a day: two capsules in the morning and two capsule in the evening
16111215|NCT02079662|Other|Behavioral, Psychological or Informational Intervention|Undergo IO intervention
16111216|NCT02079662|Other|Best Practice|Undergo standard of care
16111217|NCT02079662|Other|Cognitive Intervention|Undergo IO intervention
16111218|NCT02079662|Other|Computer-Assisted Intervention|Undergo IO intervention
16111219|NCT02079662|Other|Counseling|Undergo counseling
16111220|NCT02079662|Behavioral|Exercise Intervention|Undergo IO intervention
16111221|NCT02079662|Other|Laboratory Biomarker Analysis|Correlative studies
16111222|NCT02079662|Other|Quality-of-Life Assessment|Ancillary studies
16111223|NCT02079662|Other|Questionnaire Administration|Ancillary studies
16111224|NCT02079649|Drug|AL-53817 Ophthalmic Solution, 0.1%|
16111225|NCT02079649|Drug|AL-78843 Ophthalmic Solution, 0.03%|
16111226|NCT02079649|Drug|Dexamethasone Ophthalmic Suspension, 0.1%|
16111227|NCT02079649|Drug|AL-53817 Vehicle|Inactive ingredients used for masking purposes
16111228|NCT02079636|Drug|Abemaciclib|Administered orally
16111229|NCT02079636|Drug|Pemetrexed|Administered IV
16111230|NCT02079636|Drug|Gemcitabine|Administered IV
16111231|NCT02079636|Drug|Ramucirumab|Administered IV
16111232|NCT02079636|Drug|LY3023414|Administered orally
16111233|NCT02079636|Drug|Pembrolizumab|Administered IV
16111234|NCT02079623|Procedure|Electroporation/ Nano knife treatment|
16111235|NCT02079623|Device|NanoKnife|
16111236|NCT02079610|Behavioral|real-time fMRI neurofeedback: Amygdala|Participants are shown activity from their left amygdala in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories.
16111237|NCT02079610|Behavioral|real-time fMRI neurofeedback: HIPS|Participants are shown activity from their left horizontal segment of the intraparietal sulcus in real time and are instructed to increase the level of activity in that region by thinking of positive autobiographical memories.
16111238|NCT02079571|Dietary Supplement|Coconut water|250 ml Coconut water for each subject
16111239|NCT02079571|Dietary Supplement|ginger tea|250 ml for each subject
16111240|NCT02079558|Drug|Carbetocin|Carbetocin with single 100 microg IV dosage was used in this investigation
16111241|NCT02079558|Drug|Oxytocin|Oxytocin with 30 international units (IU) IV infusion was used in this investigation
16111242|NCT02079545|Drug|Sirukumab (IV infusion)|Participants will receive a single IV infusion of 100 mg sirukumab.
16111245|NCT02079545|Drug|Sirukumab (SC injection with PFS-U)|Participants will receive a single SC injection of 100 mg sirukumab with PFS-U.
16111246|NCT02079545|Drug|Sirukumab (SC injection with PFS-AI)|Participants will receive a single SC injection of 100 mg sirukumab with PFS-AI.
16111247|NCT02079532|Drug|rituximab [MabThera]|1 g was given by intravenous infusion on Days 1 and 15
16111248|NCT02079519|Drug|Bevacizumab|Bevacizumab was provided as a concentrate in vials.
16111249|NCT02079506|Drug|Candesartan|
16111250|NCT02079506|Drug|Rosuvastatin|
16111251|NCT02079493|Device|Total Knee Arthroplasty|Knee replacement
16111252|NCT02079480|Drug|BMS-986090|
16111253|NCT02079480|Drug|Placebo matching with BMS-986090|
16111254|NCT02079480|Drug|Keyhole limpet hemocyanin|
16111255|NCT02079467|Procedure|Unrestricted rehabilitation|Standard care range of motion restrictions will not be used
16111256|NCT02079467|Procedure|Standard rehabilitation|Standard care range of motion restrictions will remain in place
16111257|NCT02079428|Other|No interventions|
16111258|NCT02079415|Other|Prevention of complications in infants of diabetic mothers|strict glycemic control in diabetic pregnancies
16111259|NCT02079402|Drug|Isotonic crystalloids|
16111260|NCT02079389|Device|Lap+Lus|"In the standard arm (Lap) the conditions at the abdomen is only assessed by laparoscopy immediately prior to the resection. In the intervention arm the intra-abdominal conditions are also assessed by laparoscopy, but then supplemented with a laparoscopic ultrasound examination of the primary tumor, liver and retroperitoneum.
~All patients are given an CT scan of the abdomen after 3 months."
16111261|NCT02079376|Device|DIAMOND System|DIAMOND Implantable Pulse Generator (IPG)
16111262|NCT02079363|Other|No interventions, this is an observational study|
16111263|NCT02079350|Drug|%6 HES and %4 Gelofusine|
16111264|NCT02079337|Drug|Rocuronium|
16111265|NCT02079337|Drug|sugammadex|
16111266|NCT02079337|Drug|placebo|
16111267|NCT02079324|Biological|GX-051|intratumoral injection
16111268|NCT02079311|Device|Active self warming blanket|BARRIER® EasyWarm is a disposable self-warming blanket that produces heat via an exothermic chemical reaction initiated by exposure to air, resulting from the oxidation of iron.
16111269|NCT02079311|Device|Forced air warming device|Forced air warming is a temperature management unit, where heated air is used to warm subjects through convection.
16111270|NCT02079298|Drug|Treatment with fluconazole.|
16111271|NCT02079298|Drug|2. Treatment with both fluconazole and Ibuprofen.|
16111272|NCT02079298|Drug|3. Treatment with ibuprofen.|
16111273|NCT02079298|Other|4. No treatment with either fluconazole nor ibuprofen.|
16111274|NCT02079285|Procedure|EUS-FNA|
16111275|NCT02079272|Other|Helical tomotherapy for breast cancer|"At baseline, before helical tomotherapy is performed, for each included woman will have:
~measures of biomarkers of cardiac injury based on blood samples (including CRP, NT-Pro BNP, …, microparticles and miRNA)
~cardiologic examination including echocardiography for measurement of strain and strain rate
~a CT coronary angiogram for measurement of coronary plaque indexes
~Helical tomotherapy will be performed for all women included in the cohort.
~At the end of tomotherapy, follow-up will include:
~measures of biomarkers: at the end of radiotherapy, 6 months and 24 months after radiotherapy
~cardiologic examinations including a echocardiography 6 and 24 months after radiotherapy
~A CT coronary angiogram 24 months after radiotherapy"
16111276|NCT02079259|Procedure|Ultrafiltration|
16111277|NCT02079246|Drug|Idalopirdine 60 mg|once daily, encapsulated tablets, orally
16111278|NCT02079233|Drug|Cross-Linked Polyelectrolyte (CLP)|CLP was administered orally, in capsules, for 7 consecutive days.
16111279|NCT02079220|Drug|Arm A|"Capecitabine
~Oxaliplatin
~Ziv-aflibercept"
16111280|NCT02079220|Drug|Arm B|Capecitabine Oxaliplatin Ziv-aflibercept
16111281|NCT02079207|Biological|NBP606|13-valent peumococcal conjugate vaccine(13vPnC)
16111282|NCT02079207|Biological|Prodiax-23|23-valent peumococcal polysaccharide vaccine(23vPS)
16111283|NCT02079194|Drug|P2Y12 antagonist monotherapy|
16111284|NCT02079194|Drug|aspirin plus P2Y12 antagonist|
16111285|NCT02079181|Radiation|fluorine F 18 d-FMAU|Given IV
16111286|NCT02079181|Procedure|positron emission tomography|Undergo fluorine F 18 d-FMAU PET/CT scan
16111287|NCT02079181|Procedure|computed tomography|Undergo fluorine F 18 d-FMAU PET/CT scan
16111288|NCT02079168|Drug|RXI-109|
16111289|NCT02079168|Drug|Placebo|
16111290|NCT02079155|Procedure|robot-assisted laparoscopic surgery|Undergo RALP
16111291|NCT02079155|Procedure|robot-assisted laparoscopic surgery|Undergo R-LESS RP
16111292|NCT02079155|Other|laboratory biomarker analysis|Correlative studies
16111293|NCT02079155|Other|quality-of-life assessment|Ancillary studies
16111294|NCT02079155|Other|questionnaire administration|Ancillary studies
16111295|NCT02079142|Behavioral|High Intensity Strategy: Train-the-trainer|"Trainers in the high intensity condition will attend two separate workshops at Washington University in St. Louis designed to teach participants to conduct IPT and then to train IPT. Following participation in the first, two-day workshop, each trainer will return to their site and be encouraged to treat at least two cases with eating disorders or depression, audio recording each session.
~Trainers will then return to Washington University to be trained in how to train their other staff members in IPT."
16111296|NCT02079142|Behavioral|Low Intensity Strategy: Expert Consultation|Investigators will provide a two-day workshop on IPT at each site randomized to this condition to train therapists to use IPT for the treatment of Eating Disorders and depression.
16111297|NCT02079116|Other|60 grams of fat plus water solution|"A solution composed by 60 grams of fat and water at ambient temperature is administered to each volunteer, being of the with obesity group or the without obesity group, as follow:
~300 mL final volume of the solution.
~Time of oral ingestion inferior than 2 minutes.
~60 minutes before the radiopharmaceutical injection.
~12 hours fasting minimum."
16111298|NCT02079116|Other|Pure water|"Pure water at ambient temperature is administered to each volunteer, being of the with obesity group or the without obesity group, as follow:
~300 mL final volume of the solution.
~Time of oral ingestion inferior than 2 minutes.
~30 minutes before the radiopharmaceutical injection.
~12 hours fasting minimum."
16111440|NCT02077946|Drug|liraglutide|No treatment given.
16111299|NCT02079103|Device|Virtual Reality|During a 4 weeks period the patients will be offered 4-5 Virtual reality training sessions weekly of 45-60 minutes duration in addition to other rehabilitation. The Virtual reality training will be supervised by a physical or an occupational therapist. Virtual reality gaming parameters are adapted according to improving arm motor function.
16111300|NCT02079103|Behavioral|Conventional arm training|During a 4 weeks period the patients will be offered 4-5 supervised self-training sessions weekly of 45-60 minutes duration in addition to other rehabilitation. The training will be task-related and supervised by a physical or an occupational therapist. Exercises increase in difficulty according to improving arm motor function.
16111301|NCT02079090|Drug|Ketofol|0.5 mg/kg Ketamine IV, and 2 minutes later receive 1 mg/kg Propofol (Diprivan).
16111302|NCT02079090|Drug|Fentofol|1 microgram/kg Fentanyl, and 2 minutes later receive 1 mg/kg Propofol (Diprivan)
16111303|NCT02079077|Drug|Acetylsalicylic Acid (ASA)|Acetylsalicylic Acid (ASA) 81 mg. oral daily for two months
16111304|NCT02079077|Drug|Hydroxychloroquine (HCQ)|Hydroxychloroquine (HCQ) 200 mg. oral, daily for two months.
16111305|NCT02079064|Drug|Desflurane|Inhalational anesthetic
16111306|NCT02079064|Drug|Propofol|Intravenous anesthetic that can be given by continuous infusion
16111307|NCT02079051|Behavioral|Moderate intensity weight loss|A calorie restricted diet based on estimates of total energy expenditure (TEE) obtained from the measured resting metabolic rate (RMR) during a wt stable period. TEE will be estimated by multiplying RMR by a factor of 1.1-1.3 to cover activity energy expenditure based on an assessment of physical activity levels at baseline using accelerometry. We will use the TEE to create an individualized dietary rx for each pt, subtracting up to 500 calories from the estimated TEE. To ensure micronutrient needs are being met, total calories will not be decreased below 1200 kcal per day, regardless of the estimated TEE. They will receive a standard exercise program that will be designed to promote exercise energy expenditure of approximately 1200 kcal/week. We will prescribe resistance training for 2 days per week with a loading intensity of 60% of 1 rep max and volume of 3 sets at 8 reps per exercise. Aerobic training will be prescribed for 3 days per week.
16111308|NCT02079051|Behavioral|High intensity medical weight loss|Placed on complete meal replacement (MR) using the OPTIFAST medical wt loss protocol. Pts will consume a min of 86 g of protein daily in 5-6 servings of MR. Min caloric intake will be 960 kcal/day with adjustments in intake made based on BMI and activity levels, holding the percent of calories from protein constant at 35%. The MRs provide 100% of daily recommended needs for micronutrients and will be supplied weekly at clinic visits by the study. Pts will begin to incorporate food into their routine beginning at week 13 with guidance from a dietitian. From weeks 13-26, caloric prescriptions will be between 1100 to 1600 kcal/day, using a combo of MRs and food. Will receive an exercise program designed to promote exercise energy expenditure of approximately 1200 kcal/week. We will prescribe resistance training for 2 days per week with a loading intensity of 60% of 1 rep max and volume of 3 sets at 8 reps per exercise. Aerobic training will be prescribed for 3 days per wk.
16111309|NCT02079038|Device|Totalis|
16111310|NCT02079038|Procedure|Comparator Surgical Procedure|
16111311|NCT02079025|Device|High-resolution ultrasound guided prostate biopsy|Ultrasound guided prostate biopsy using ultra-high resolution ultrasound system
16111312|NCT02079025|Device|Standard ultrasound guided prostate biopsy|Ultrasound guided prostate biopsy using standard of care ultrasound system
16111313|NCT02079012|Behavioral|10-week walking program|
16111314|NCT02078986|Other|Whole Body Electromyostimulation|Supervised WB-EMS, 3 sessions in 2 weeks (1,5 sessions/week) for 14 weeks
16111315|NCT02078986|Other|High Intensity Resistance Exercise Training|Supervised High Intensity Resistance Exercise Training (HIT) 2-3 sessions/week for 14 weeks
16111316|NCT02078973|Drug|15 mg tolvaptan|15 mg pr day for 1 day
16111317|NCT02078973|Drug|30 mg tolvaptan|30 mg pr day for 1 day
16111318|NCT02078973|Drug|45 mg tolvaptan|45 mg pr day for 1 day
16111319|NCT02078973|Drug|Placebo|1 tablet Unikalk pr day for 1 day
16111320|NCT02078960|Drug|Omacetaxine mepesuccinate|3.5 mg omacetaxine mepesuccinate and 10 mg mannitol; The first dose of the day for cycle 1 will be administered at the investigational center. Subsequent doses (in prefilled syringes) may be administered on an outpatient basis after training takes place
16111321|NCT02078947|Behavioral|High Intensity Exercise|
16111322|NCT02078947|Behavioral|Moderate Continuous Exercise|
16111323|NCT02078947|Behavioral|Usual Care|
16111324|NCT02078934|Procedure|Endoscopic Gastric Plication|Evaluate the efficacy of endoscopic suturing for weight loss
16111325|NCT02078921|Drug|Sodium Nitrate|
16111326|NCT02078921|Drug|Placebo|
16111327|NCT02078908|Drug|Sodium nitrite, 40 micrograms/kg/hour|Continuous 2 hour infusion of sodium nitrite, 40 micrograms/kg/hour
16111328|NCT02078908|Drug|Sodium nitrite, 120 micrograms/kg/hour|Continuous 2 hour infusion of sodium nitrite, 120 micrograms/kg/hour
16111329|NCT02078908|Drug|Sodium nitrite, 240 micrograms/kg/hour|Continuous 2 hour infusion of sodium nitrite, 240 micrograms/kg/hour
16111330|NCT02078908|Drug|Placebo|Continuous 2 hour infusion of sodium chloride, 25 ml/hour
16111331|NCT02078895|Drug|Botox|Peri-Ureteral and Intradetrusor Injection of Botulinum Toxin Type A
16111332|NCT02078882|Biological|abatacept|125 mg subcutaneously each week for 24 weeks
16111333|NCT02078869|Drug|Progesterone in oil|
16111334|NCT02078869|Drug|vaginal progesterone suppositories|
16111335|NCT02078856|Drug|A3384|
16111336|NCT02078843|Drug|Gallium-68-DOTATATE PET/CT (index test)|Somatostatin-based imaging tracer
16111337|NCT02078843|Drug|Indium-111-Octreoscan (standard test)|Somatostatin-based imaging tracer
16111338|NCT02078830|Device|3M™ Tegaderm™ CHG I.V. Securement Dressing|Chlorhexidine gluconate (CHG) has been dissolved into a soft gel pad (3x4 cm) to provide a reservoir for consistent and continuous antimicrobial action over time. The gel pad is active on contact without requiring additional moisture. CHG migrates under the catheter to provide continuous circumferential antimicrobial protection at the insertion site. Soft and conformable, the gel pad moulds around the catheter and hub.
16111339|NCT02078830|Device|Placebo Comparator: 3M™ Tegaderm™ I.V. Advanced Dressing|Placebo Dressing with the same shape like the CHG-Dressing without CHG.
16111340|NCT02078817|Drug|Ketamine|IV infusions of 0.5mg/kg of Ketamine hydrochloride over a 40-minute infusion period. Participants will receive a total of 6 doses over a 2-week period.
16111341|NCT02078804|Procedure|Colonoscopy|20 000 individuals will be randomised to a primary screening colonoscopy and 60 000 to take a feces test for occult blood (FIT) and if positive (10% of individuals) they will be offered a follow-up colonoscopy.
16111342|NCT02078791|Drug|Botox infiltration|botox cervical infiltration in a group
16111343|NCT02078791|Behavioral|Psychology therapy|Psychology problem solving therapy lead by specialized nurses.
16111344|NCT02078791|Other|Botox infiltration & psychology therapy|Botox infiltration in cervical region and psychology problem solving therapy lead by specialized nurses.
16111345|NCT02078778|Device|CPAP|3 months of CPAP treatment
16111346|NCT02078752|Drug|PF-06647263|Part 1- PF-06647263 will be administered intravenously in either a 21 day cycle or weekly in cohorts of 2 or more patients starting at a dose of 0.015 mg/kg. Increases in dose will continue until MTD is determined.
16111347|NCT02078752|Drug|PF-06647263|Part 2- Patients with triple negative breast cancer will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.
16111348|NCT02078739|Behavioral|Yoga Program at home using internet technology|
16111349|NCT02078726|Drug|Glucagon|glucagon (hormone produced by the body)
16111350|NCT02078713|Behavioral|Contraceptive Decision Support Tool|"The decision support tool:
~Provides an educational session about different aspects of contraception
~Elicits patient preferences about different aspects of contraception
~Identifies potential contraindications to certain contraceptive methods
~Allows the patient to view details about and compare available contraceptive methods
~Suggests methods most appropriate based on the patient's preferences
~Collects questions the patient may have for her provider
~Generates a printout the patient can bring to her contraceptive counseling visit"
16111351|NCT02078700|Other|The early palliative care programme|The intervention consists of an early integration of a palliative care programme with the standard care performed by the oncologists-pneumologists that are following the cancer patients. The intervention will be delivered by the specialised Palliative Care Unit (PCU) of the hospital. Each patient meets the professionals of the PCU by 30 days by cancer diagnosis and at least monthly thereafter in the outpatint settings.
16111352|NCT02078687|Dietary Supplement|Enfamil HM fortifier, Mead Johnson|Enfamil was added to a small amount of mothers expressed milk and given in a bottle or with a small cup every day. Group 2 (HMF) received 5 packets each day for 4 month containing; 17.5 kcal, 1.375 g protein/ 5 packets
16111353|NCT02078687|Dietary Supplement|Enfalac Premature Formula, Mead Johnson Nutritionals|"Group 3 received Enfalac containing:
~68 kcal, 2 g protein, 7.4 g carbohydrate, 3.5 g fat/ 100 ml"
16111354|NCT02078687|Dietary Supplement|Mothers own milk|Group 1 received mothers own milk without fortification
16111355|NCT02078674|Biological|Monovalent Avian Influenza VLP (H7N9)|
16111356|NCT02078674|Biological|Matrix-M1™ adjuvant|
16111357|NCT02078674|Biological|Placebo|
16111358|NCT02078661|Drug|PG101|A topical gel containing either 1% or 0.25% PG101 active.
16111359|NCT02078648|Biological|SL-701; poly-ICLC (polyinosinic-polycytidylic acid stabilized with polylysine and carboxymethyl cellulose)|Within 20 minutes following the administration of the SL-701 emulsion, poly-ICLC should be administered as an IM injection in the same extremity (within 3 cm whenever possible) as was administered the SL-701 (deltoid muscle, unless contraindicated).
16111360|NCT02078648|Drug|Bevacizumab|Following the administration of SL-701 and poly-ICLC, bevacizumab will be administered IV at a dose of 10 mg/kg. Bevacizumab infusions may occur over 30, 60 or 90 minutes in accordance with institutional practices and guidelines.
16111361|NCT02078635|Behavioral|Portfolio Plus Diet|Foods on the Portfolio Plus plan will contribute 9 g/1000 kcal viscous fibre as β-glucan (oats, barley, oat bran bread and soups) and psyllium (cereal), 1 g plant sterol/1000 kcal diet (in sterol margarine), 22.5 g soy protein/1000 kcal (soy burgers, dogs, links, other soy meat analogues, soy milks, yogurts and cheese) and additional sources of plant proteins from pulses (eg. lentils, chickpeas, beans, etc); and 22.5 g almonds or equivalent of other nuts/1000 kcal and increase MUFA (as olive and canola oils, avocados, nuts, margarine and salad dressings). The glycemic index will be reduced from 83 to 70 GI units (bread scale)
16111362|NCT02078635|Behavioral|DASH-like (high fibre) dietary advice|Dietary advice will be given to encourage intake of whole grain foods (brown rice, whole wheat breads, muffins and breakfast cereals); to reduce red meat consumption, choose low fat dairy foods and a control margarine
16111363|NCT02078622|Other|Respiratory Therapist Education and Case Management|Respiratory Therapists will conduct home care visits over a period of one-year at two-week intervals
16111364|NCT02078609|Drug|LGH447|LGH447 in patients with AML or MDS
16111365|NCT02078609|Drug|LGH447 + midostaurin|LGH447 + midostaurin in patients with AML
16111366|NCT02078596|Drug|Divalproex|Patients were randomly assigned to receive divalproex or placebo first, follow by the converse treatment, for six weeks each
16111367|NCT02078583|Drug|Fentanyl|
16111368|NCT02078583|Drug|Remifentanil|
16111369|NCT02078583|Drug|Normal saline|
16111370|NCT02078557|Drug|MK-8892|
16111371|NCT02078544|Other|Integrated Molecular Analysis|
16111372|NCT02078518|Other|Questionnaires|
16111373|NCT02078505|Behavioral|diet|Carbohydrate poor diet
16111374|NCT02078492|Drug|10 mg of Ketorolac|Patients will receive 10 mg of Ketorolac for pain control.
16111375|NCT02078492|Drug|15 mg of Ketorolac|Patients will receive 15mg of Ketorolac for pain control.
16111376|NCT02078492|Drug|30 mg of Ketorolac|Patients will receive 30mg of Ketorolac for pain control.
16111377|NCT02078479|Procedure|20 Hz, 10 s, 10 trains with inter-train interval 30 s 2000 pulses , intensity 80% over hand area daily for 10 consecutive days (5 days/week).|
16111378|NCT02078479|Procedure|sham rTMS (same parameters but with coil elevated and angled away from the head)every day for ten consecutive days (5 days/week).|
16111379|NCT02078466|Other|Assessment of functional ability and follow-up at home|Assessment of functional ability and follow-up at home
16111380|NCT02078453|Procedure|Dental treatment|Dental treatment of all dental needs present in the children related or not to the dental caries.
16111381|NCT02078440|Drug|Bromocriptine mesylate|Cycloset (bromocriptine mesylate quick release) 0.8 mg tablets, weight adjusted 1.6 mg- 4.8 mg
16111382|NCT02078427|Biological|ADVATE|Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method
16111383|NCT02078427|Biological|ADYNOVI|Antihemophilic Factor (Recombinant) Pegylated
16111384|NCT02078388|Drug|Doxorubicin|
16111385|NCT02078375|Dietary Supplement|Protein|whey protein plus casein protein
16111386|NCT02078375|Dietary Supplement|Carbohydrate (Placebo)|The twice daily placebo will consist of a carbohydrate and a small amount of protein
16111387|NCT02078375|Other|Resistance Exercise Program|All participants will be enrolled in an individually supervised twice weekly (for 16 weeks) resistance exercise program
16111388|NCT02078349|Drug|KPT-330|Each dose will consist of KPT-330 (Selinexor) for oral administration on an mg/m2 basis, and should be based on the patient's actual calculated body surface area (BSA) at baseline. Patients with a BSA >2.5 m(2) will receive a dose based upon a 2.5 m(2) BSA.
16111389|NCT02078336|Drug|Midazolam Mylan|
16111390|NCT02078336|Drug|Lorazepam Mylan|
16111391|NCT02078336|Drug|Valium + Akineton + Dehydrobenzperidol + Atropine sulfate|
16111392|NCT02078323|Drug|Linaclotide|
16111393|NCT02078323|Drug|Placebo|
16111394|NCT02078310|Drug|ITI-007|ITI-007 for Part 1
16111395|NCT02078310|Drug|Placebo|ITI-007 for Part 1
16111396|NCT02078310|Drug|ITI-007|ITI-007 for Part 2
16111397|NCT02078310|Drug|Placebo|Placebo for Part 2
16111398|NCT02078284|Biological|CPP|One unit of frozen CPP contains approximately 3.4 x 10^11 irradiated platelets and approximately 6% DMSO in sterile 0.9% sodium chloride solution (total volume of 20 mL to 35 mL) stored frozen at ≤ -65°C.
16111399|NCT02078284|Biological|LSP|
16111400|NCT02078271|Other|FBDG group|The group received food based dietary guidelines for complementary feeding
16111401|NCT02078271|Other|Stimulation|The group received psychosocial stimulation
16111402|NCT02078271|Other|Combinded FBDG and stimulation|The group received both FBDG and psychosocial stimulation
16111403|NCT02078271|Other|Control group|
16111404|NCT02078258|Behavioral|ABMT|During a two-week period, 8 sessions of a modified dot probe task for attentional bias modification training (ABMT) condition, 8 sessions of a classic dot probe task for placebo training (PT) condition.
16111405|NCT02078245|Other|MRI|MRI
16111406|NCT02078232|Device|puncture of head of pancreas|"puncture of head of pancreatic solid mass with fine needle aspiration under endoscopic ultrasonographic control.
~randomization: puncture with either 22G needle or 19G flex needle"
16111407|NCT02078232|Device|puncture of head of pancreas|"puncture of head of pancreatic solid mass with fine needle aspiration under endoscopic ultrasonographic control.
~randomization: puncture with either 22G needle or 19G flex needle"
16111408|NCT02078219|Drug|RDEA3170|Oral Treatment
16111409|NCT02078219|Drug|Allopurinol|Oral Treatment
16111410|NCT02078219|Drug|Placebo|Oral Treatment
16111411|NCT02078206|Other|Neurocognitive stimulation|
16111412|NCT02078193|Drug|Belatacept|Patients will be converted from their MMF to Belatacept
16111413|NCT02078180|Drug|generic bupropion|We are comparing different formulations of bupropion that release this drug at different rates. The abbreviation IR75 means immediate release and the number is the dose in mg. The other abbreviations represent SR for sustained-release and XL for extended release, which release the drug slower than the IR formulation.
16111414|NCT02078167|Other|nutraceutical combination (red yeast rice, policosanols and berberine)|
16111415|NCT02078141|Drug|18F-deoxyglucose (FDG)|18F-deoxyglucose (FDG) One injection of 3.5 MBq/kg of 18FDG with a minimum of 220 MBq and a maximum of 400 MBq
16111416|NCT02078128|Dietary Supplement|oral beta-glucans|30 mg/kg, oral every day until wound healed completes or unacceptable toxicity develops.
16111417|NCT02078128|Drug|oral sugar powder|30 mg/kg, oral every day until wound healed completes or unacceptable toxicity develops.
16111418|NCT02078102|Drug|Meloxicam|15 mg tablets of Meloxicam will be taken orally in the morning, with or without food.
16111419|NCT02078102|Drug|Filgrastim|Filgrastim will be subcutaneously injected in one or two sites at home.
16111420|NCT02078089|Drug|Morphine|Morphine will be given to patients as part of their standard care
16111421|NCT02078089|Drug|Oxcarbazepine|Can be taken with or without food at the same time as morphine. Morphine will be provided to patients free of charge.
16111422|NCT02078076|Device|Magnetic Resonance Cardiac Imaging (with Gadolinium)|
16111423|NCT02078063|Drug|Mepivacaine|10 ml of Mepivacaine for injection (Carbocain®) 10 mg/ml instilled into the uterus through a hydrosonography catheter
16111424|NCT02078063|Drug|Placebo|10 ml of NaCl 0.9 mg/ml instilled into the uterus through a hydrosonography catheter
16111425|NCT02078050|Other|Phrenic nerves magnetic stimulations|
16111426|NCT02078037|Device|Arctic Sun cooling device|The Arctic Sun® 5000 Temperature management systems (Bard Medical), a non- invasive, surface cooling technology that allows rapid and precise manipulation of core body temperature will be employed to maintain normothermia (normal temperature) in patients with ICH randomized to the treatment group.
16111427|NCT02078037|Other|Standard of Care|Patient will be given standard fever management (acetaminophen + cooling blanket at the discretion of the treating physician)
16111428|NCT02078024|Drug|IVM plus ALB|
16111429|NCT02078024|Drug|IVM|
16111430|NCT02078011|Device|High Intensity Focused Ultrasound|The Echopulse device is a computer driven system which uses ultrasound to guide a high intensity focused ultrasound beam to a targeted area (the fibroadenoma in the breast).
16111431|NCT02077998|Radiation|carbon C 14 oxaliplatin|Given IV
16111432|NCT02077998|Drug|oxaliplatin|Given IV
16111433|NCT02077998|Other|laboratory biomarker analysis|Correlative studies
16111434|NCT02077985|Behavioral|Sensory Adapted Dental Environment|See study arm description.
16111435|NCT02077972|Device|High intensity whole-body infrared heating|The Whole Body Hyperthermia system uses water-filtered infrared-A (wIRA) heat radiation. The rise in the body's core temperature is correspondingly rapid and well-tolerated. There are two phases of the thermal challenge, 1) Irradiation phase during which the patient lies recumbent with his/her head positioned outside the tent. The wIRA irradiators are arranged above the exposed upper part of the body; and 2) heat retention phase during which the patient lies in the chamber with the walls of the tent positioned to retain heat. Core body temperatures will be raised to those comparable to a mild fever 37.8-38.5°C.
16111436|NCT02077959|Drug|lenalidomide|Given PO
16111437|NCT02077959|Biological|pidilizumab|Given IV
16111438|NCT02077959|Other|pharmacological study|Correlative studies
16111439|NCT02077959|Other|laboratory biomarker analysis|Correlative studies
16111442|NCT02077933|Drug|alpelisib|"alpelisib is administered orally once a day on a continuous dosing schedule and dosed on a flat-fixed dose and not adjusted by body weight or body surface area, starting on Day 8 of Cycle 1 in the dose escalation and Day 1 of Cycle 1 in the dose expansion.
~In the doublet dose escalation, the alpelisib starting dose is 300 mg. The alpelisib dose may be escalated or de-escalated, as needed.
~In the triplet dose escalation part, the alpelisib starting dose is one dose level lower of the MTD as determined during the doublet escalation. The alpelisib dose may be escalated or de-escalated, as needed.
~In the doublet dose expansion and triplet dose expansion (patients assigned to alpelisib, everolimus and exemestane), alpelisib is administered at the recommended dose determined in the dose escalation.
~In the triplet dose expansion (patients assigned to alpelisib and exemestane), alpelisib is administered at a dose of 250 mg daily."
16111443|NCT02077933|Drug|everolimus|"everolimus is administered orally once a day on a continuous dosing schedule and dosed on a flat-fixed dose and not adjusted by body weight or body surface area, starting on Day 1 of cycle 1 in both the dose escalation and dose expansion parts.
~In the dose escalation part, the everolimus starting dose is 2,5 mg. In the dose expansion part, everolimus is administered at the recommended dose determined in the dose escalation."
16111444|NCT02077933|Drug|exemestane|exemestane is administered orally once a day on a continuous dose of 25 mg starting on Day 1 of Cycle 1 in both the dose escalation and dose expansion.
16111445|NCT02077920|Drug|Chlorhexidine|"SFDA Approval No. H21020748; Jinzhou Jiu Tai Pharmaceutical Co., Ltd., Liaoning, China
~Drug administration and preparation:
~Drug administration: oropharyngeal rinsing and suctioning of subglottic secretions
~Drug preparation: 0.12% chlorhexidine solution prepared with distilled water that has been sterilized by autoclaving"
16111446|NCT02077920|Drug|0.9% sodium chloride injection|SFDA Approval No. H20045252; Shenyang Zhiying Pharmaceutical Co., Ltd., Liaoning, China
16111447|NCT02077920|Device|Endotracheal tube|Type 5-10115; size 7.0 mm, 7.5 mm, or 8.0 mm; purchased from Teleflex Medical (USA).
16111448|NCT02077920|Device|Fiber bronchoscope|For suctioning of subglottic secretions. BF-P30 (Olympus, Japan); BF-1T20 (Olympus, Japan); or FB-18BS (Pentax, Japan).
16111449|NCT02077907|Dietary Supplement|Super Cereal Plus (SC+)|
16111450|NCT02077907|Dietary Supplement|Super Cereal (SC), fortified oil, sugar|
16111451|NCT02077907|Dietary Supplement|Plumpy Sup|
16111452|NCT02077907|Dietary Supplement|Corn Soy Blend 14 (CSB14) and fortified oil|
16111453|NCT02077881|Drug|Nab-Paclitaxel|Nab-Paclitaxel 125 mg/m^2 given intravenously over 30-40 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity.
16111454|NCT02077881|Drug|Gemcitabine|Gemcitabine 1000 mg/m^2 given intravenously over 30 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest. Patients will continue until they experience disease progression or significant toxicity.
16111455|NCT02077881|Drug|Indoximod|"Indoximod will be administered in escalating doses. Initial dosing will be 600 mg BID by mouth with escalation planned to 1200 mg BID by mouth
~Indoximod in the form of 200 mg capsules will be given (3, 5, and 6 capsules depending on the escalated dose). Indoximod should be taken with water by mouth one hour before breakfast and one hour prior to dinner. The medication should be taken twice daily for 28 days each cycle. Patients will continue until they experience disease progression or toxicity."
16111456|NCT02077868|Other|Usual Maintenance|Usual maintenance therapy according to local investigator's practice, e.g. treatment break, reduced treatment, continued treatment, and other
16111457|NCT02077868|Drug|MGN1703 treatment|MGN1703 will be used as single agent maintenance treatment
16111458|NCT02077842|Device|Nasal Continuous Positive Airway Pressure|Nasal continuous positive airway pressure at 10 cmH2O
16111459|NCT02077842|Device|Low Flow Oxygen|Low flow oxygen delivered via face mask at 8 litres per minute
16111460|NCT02077829|Behavioral|Illness Management and Recovery|Evidence-based practice given individually or in groups, weekly for 10-12 months.
16111461|NCT02077803|Drug|Canagliflozin, 100 mg|Each tablet contains canagliflozin (CANA) of 100 mg to be taken orally (by mouth).
16111462|NCT02077803|Drug|Metformin XR, 500 mg|Each tablet contains metformin extended release (MET XR), 500 mg, to be taken orally (by mouth).
16111463|NCT02077803|Drug|CANA/MET XR FDC, Formulation 1, 50 mg/1000 mg|Each tablet contains 50 mg of canagliflozin and 1000 mg of metformin HCl granulate, formulation 1, to be taken orally.
16111464|NCT02077803|Drug|CANA/MET XR FDC, Formulation 2, 50 mg/1000 mg|Each tablet contains 50 mg of canagliflozin and 1000 mg of metformin HCl granulate, formulation 2, to be taken orally.
16111465|NCT02077790|Device|CASIA Cornea/Anterior Segment OCT SS-1000|"The SS-1000 is a three-dimensional, non-contact, non-invasive high resolution optical coherence tomography imaging device based on the principal of Swept Source OCT. The system achieves high resolution imaging of 10 μm (Axial) and 30 μm (Transverse) and high speed scanning of 30,000 A-scans per second."
16111466|NCT02077777|Drug|Mesalazine|Mesalazine cpr 800 mg t.i.d. for 3 months
16111467|NCT02077764|Procedure|OCT and coronary angiography|
16111468|NCT02077764|Procedure|Right heart cat.|
16111469|NCT02077764|Radiation|PET|
16111470|NCT02077764|Procedure|Echocardiography|
16111471|NCT02077764|Procedure|exercise test|
16111472|NCT02077764|Other|blood samples|
16111473|NCT02077751|Drug|biotin labelled RBCs|Autologous red blood cells are biotin labelled and transfused to the subject. Survival of these red blood cells is tracked through examination of blood samples until no biotin labelled red blood cells remain.
16111474|NCT02077738|Device|HFCWO (Hill-Rom Vest™ Airway Clearance System)|study subjects in the HFCWO group received HFCWO for 15 min twice a day for 5 days after extubation
16111475|NCT02077725|Other|interdisciplinary polypharmacy clinic visit|
16111476|NCT02077712|Drug|intranasal dexmedetomidine|1 or 2 ug/kg of intranasal dexmedetomidine
16111477|NCT02077699|Dietary Supplement|Lactobacillus casei DG|Lactobacillus casei DG (24 billion of live cells per pill) - 2 pills b.i.d. for 4 weeks
16111478|NCT02077686|Behavioral|Education - Diabetes and Travel|"Based on the treatment and education programme PRIMAS a problem-specific education module regarding Diabetes and Travel was created. The module covers specific and detailed aspects of the topic travel such as insulin adaption to intercontinental flights, dealing with exotic food, and treatment goals during vacation. With this module, a more comprehensive education of patients with specific interest is possible."
16112433|NCT02070458|Drug|mitoxantrone hydrochloride|Given IV
16111479|NCT02077660|Dietary Supplement|Four green tea bags per day for 12 weeks|Four green tea bags per day for 12 weeks
16111480|NCT02077660|Other|4 daily placebo tea bags for 12 weeks|4 daily placebo tea bags for 12 weeks
16111481|NCT02077634|Drug|abiraterone acetate + prednisone + LHRH-therapy|Hormon therapy will go on
16111482|NCT02077634|Drug|abiraterone acetate + prednisone|ormon therapy will be stopped
16111483|NCT02077621|Drug|PG2|Powder for Injection, 500 mg PG2/500 ml normal saline
16111484|NCT02077621|Drug|Placebo|500 mL normal saline
16111485|NCT02077595|Device|transcutaneous electrical nerve stimulation, TENS|Then participants will receive stimulation for 20 minutes.
16111486|NCT02077569|Drug|AZD5363|Stage 1: AZD5363 480mg or placebo twice daily oral dosing for 4 and 1/2 days (9 doses) Stage 2: AZD5363 360mg or 240mg daily oral dosing for 4 and 1/2 days (9 doses)
16111487|NCT02077556|Drug|Everolimus|Everolimus: 1 mg orally every 12 hours from post-operation day 1 to achieve trough concentrations of 3-8 ng/mL
16111488|NCT02077556|Drug|Mycophenolate mofetil|Mycophenolate mofetil: 10-15 mg/kg orally every 12 hours from post-operation day 1 (decrease 50% dose if white blood cell < 4000/mcL)
16111489|NCT02077556|Drug|Tacrolimus|Tacrolimus: 0.05-0.075 mg/kg orally every 12 hours from post-operation day 1 to achieve trough concentrations of 8-12 ng/mL
16111490|NCT02077556|Drug|Methylprednisolone|Methylprednisolone: 50 mg iv every 6 hours on post-operation day 1, 40 mg iv every 6 hours on post-operation day 2, 30 mg iv every 6 hours on post-operation day 3, 20 mg iv every 6 hours on post-operation day 4, 20 mg iv every 8 hours on post-operation day 5, 20 mg iv every 12 hours on post-operation day 6, 20 mg iv on post-operation day 7
16111491|NCT02077556|Drug|Prednisolone|Prednisolone: 20 mg orally once a day from post-operation day 8 to post-operation week 4, then titrated gradually
16111492|NCT02077543|Device|Brain Tissue Imprint - Medical Device (ProTool)|genomic, transcriptomic and proteomic studies.
16111493|NCT02077517|Procedure|Roux en Y Gastric Bypass|
16111494|NCT02077504|Other|MEG and MRI|CONDUCTOME
16111495|NCT02077491|Other|High-protein diet and resistance training|The intervention includes 1.7g/kg/day during admission combined with resistance training and a daily protein and energy supplement after discharge.
16111496|NCT02077478|Device|Remifentanil and propofol administration using TCI|
16111497|NCT02077478|Device|Remifentanil and propofol administration using MCI|
16111498|NCT02077465|Drug|Andecaliximab|400 mg andecaliximab administered intravenously
16111499|NCT02077465|Drug|Placebo to match Andecaliximab|Placebo to match andecaliximab administered intravenously
16111500|NCT02077452|Drug|HMS5552|
16111501|NCT02077452|Drug|Placebo|
16111502|NCT02077439|Device|Hand Robotic Training|Training for 20 sessions for one hour, 3-5 times per week.
16111503|NCT02077439|Device|Hand and Arm Robotic Training|Training for 20 sessions for one hour, 3-5 times per week.
16111504|NCT02077439|Other|Conventional therapy|Training for 20 sessions for one hour, 3-5 times per week.
16111505|NCT02077426|Other|Regional Specific Training (RSTS)|The RSTS protocol was designed to focus on specific peripheral muscle groups without imposing a significant cardiorespiratory strain. Each exercise involved contractions with moderate load but with an extended duration of up to six minutes. Eight specific exercises were performed to target all major muscle groups and enable the routine to be completed within 60 minutes including warm-up, rest periods and stretching between exercises, and cool down exercises.
16111506|NCT02077413|Procedure|Healthy Muscle Group|Six subjects will be enrolled in this group. MRI measures will be performed at baseline and 48 hours post-exercise, when the largest amount of muscle damage is typically observed. They will be tested for maximum strength of the dorsiflexors and then undergo an eccentric exercise protocol for both lower legs on the Biodex with varying loads. Approximately two days after the exercise protocol, the participants will have another MRI of the lower legs to assess any change in T2 relaxation time as a construct of muscle edema/damage.
16111507|NCT02077413|Procedure|Stretch-Contract Pre-rehabilitation Group|"All subjects will be tested initially with an MRI, blood work for creatine kinase levels (CK), subjective report of pain, range of motion (ROM) of the lower leg/ankle, and maximum strength of the dorsiflexors. They will also receive the stretch-contract protocol on one leg consisting of the following: a 5 second passive stretch of the dorsiflexors, followed immediately by a 5 second active isometric contraction of the dorsiflexors, and a 5 second rest/relaxation period. This cycle will continue for a duration of ~5 minutes."
16111508|NCT02077413|Procedure|Stretch-Contract Control Group|All subjects will be tested initially with an MRI, blood work for creatine kinase levels (CK), subjective report of pain, range of motion (ROM) of the lower leg/ankle, and maximum strength of the dorsiflexors.
16111509|NCT02077413|Procedure|Muscle Atrophy|These subjects will undergo MRI and strength testing at baseline and will also be assessed for CK levels, pain report, and ROM. They will then receive an eccentric loading paradigm for the dorsiflexor muscles of the involved leg using an isokinetic dynamometer with varying loads. Approximately two days after the exercise protocol, follow-up assessment of MRI, CK levels, pain report, ROM, and strength will be done.
16111510|NCT02077400|Drug|Cephazolin|Cephazolin
16111511|NCT02077387|Behavioral|CHild Inhibitory Control (CHIC) Play|CHIC Play paradigm: Children will exposed to several play paradigms that enhance inhibitory control around snack foods. Children will receive the intervention in the preschool setting over a 3 week period.
16111512|NCT02077387|Behavioral|Attention control|Children will receive an equal amount of time with the RA, but focus on other healthy behaviors and not use inhibitory control skills training techniques
16111513|NCT02077374|Drug|IDN-6556|25 mg BID for 28 days
16111514|NCT02077374|Other|Placebo|Placebo BID for 28 Days
16111515|NCT02077361|Genetic|rAAV2.REP1 vector|No additional details needed.
16111516|NCT02077348|Drug|Insulin withdrawal|Withdrawal of usual (evening) insulin, replaced by Insuman Rapid (10% of the amount of usual evening insulin) as a continuous IV- administration overnight until 8 o'clock on the study day.
16111517|NCT02077348|Drug|Norditropin|0,4 mg of GH administered at 7.05 A.M. on the study day.
16111561|NCT02076893|Drug|gabapentin|The active comparator arm will receive gabapentin as per dosing specifics listed in the study arm description.
16111562|NCT02076893|Drug|Tramadol|Both study arms will receive tramadol per dosing details listed in the study arm descriptions.
16112434|NCT02070458|Drug|etoposide|Given IV
16111518|NCT02077335|Radiation|HDR brachytherapy monotherapy|"Radiation therapy in the study consists of treatment with 2 separate interstitial HDR brachytherapy procedures with temporary interstitial catheters, each with one fraction of 13.5 Gray (Gy). Both procedures will be done in an identical manner. The 2 procedures will be separated by an interval of 7-14 days Treatments will be done with interstitial catheters inserted transperineally with transrectal ultrasound guidance under sterile conditions. Optimization of treatment plan will be done with Brachyvision software (Varian, Palo Alto CA) based on CT-scan imaging done post-implant. Optimization parameters will be the following:
~Prostate :
~V100 > 95%
~V150 30-35%
~V200 < 15%
~D90 > 90% (12,15Gy)
~Bladder
~• V75 < 1cc
~Rectum
~• V75 < 1cc
~Urethra
~V125 = 0cc D10 < 120%
~Treatments will be carried out with an Iridium-192 afterloader. Source and all catheters will be removed from the patient at the end of the procedure."
16111519|NCT02077322|Device|Silastic Spacer|The Silastic spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6 to 14 days following surgery.
16111520|NCT02077322|Device|Merocel Spacer|The Merocel spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6 to 14 days following surgery.
16111521|NCT02077309|Drug|Linagliptin|
16111522|NCT02077309|Drug|Placebo|
16111523|NCT02077270|Procedure|electroacupuncture|Patients allocated to this arm will receive electro-acupuncture bilaterally on the following points which are considered relevant both for sedation and abdominal distention:LI4 (Hegu),ii. St36 (Zusanli), Sp6 (Sanyinjiao), St25 (Tianshuv),. Du20 (Baihui),
16111524|NCT02077257|Drug|Rosuvastatin|Rosuvastatin 20 mg/d compared to 10 mg/day
16111525|NCT02077244|Behavioral|Follow up talks|Nurse led follow up talks at the ward and one and two months later.
16111526|NCT02077231|Drug|Vitamin A|use one drop in the eye
16111527|NCT02077231|Drug|carbomer eye gel|use one drop in the eye
16111528|NCT02077218|Procedure|computed tomography|Undergo cardiac CT
16111529|NCT02077218|Other|cytology specimen collection procedure|Undergo collection of blood samples
16111530|NCT02077218|Other|laboratory biomarker analysis|Correlative studies
16111531|NCT02077218|Other|questionnaire administration|Ancillary studies
16111532|NCT02077205|Behavioral|Manualised Cognitive Behavioral Therapy|16 Sessions of Manualised Cognitive Behavioral Therapy in a Routine Care Setting
16111533|NCT02077192|Drug|Fostamatinib Disodium|Fostamatinib Disodium tablet 100 mg or 150 mg by mouth twice a day
16111534|NCT02077179|Behavioral|HIP Program|"The entirety of the HIP Program is delivered through an interactive mobile website.
~The physical activity portion of the program consists of daily step counting, prescribed aerobic activity, structured strength and toning workouts, and daily stretching. The program was designed by a local trainer, specializing in postnatal exercise, to increase gradually in intensity, while encouraging a more active lifestyle. The program is designed to be completed at home with minimal equipment.
~The nutrition portion of the program consists of 16 video tutorials developed by a local Registered Dietitian and weekly diet logs. The video tutorials cover all aspects of healthy eating, from the basics of Canada's Food Guide, to smart snacking, to eating healthy over the holidays."
16111535|NCT02077166|Drug|Ibrutinib|
16111536|NCT02077166|Drug|Lenalidomide|
16111537|NCT02077166|Drug|Rituximab|
16111538|NCT02077153|Behavioral|Reminiscence therapy|
16111539|NCT02077153|Behavioral|Active participation in group setting|
16111540|NCT02077140|Drug|MDT-10013|
16111541|NCT02077140|Drug|Standard of care for pain|
16111542|NCT02077114|Biological|Vaccine consisting of a peptide derived from the protein IDO|All patients will receive seven vaccines containing IDOlong
16111543|NCT02077101|Other|Questionnaire|
16111544|NCT02077101|Other|Interview|
16111545|NCT02077088|Other|galactooligosaccharide|addition of food grade GRAS (Generally Regarded As Safe) galactooligosaccharides
16111546|NCT02077075|Behavioral|Web-based weight loss program|A 4-week web-based wellness program.
16111547|NCT02077075|Behavioral|On-line health coaching|A 4-week web-based wellness program with weekly personalized on-line health coaching.
16111548|NCT02077049|Device|serious games|"Execution of computer-based games that stimulate patient's mobility. The game is displayed on a Television (TV) screen and the patient's movements are detected by the sensors of the Kinect® camera, requiring therefore no game console.
~The Fit Bit®, a mobility tracker device, is attached at the patient's belt the whole day and measure all the trips performed and stairs climbed.
~This serious games program is instructed individually by experienced physiotherapists."
16111549|NCT02077049|Other|Conventional self-training|Participants perform conventional physical exercises that train their balance capabilities. There are instructed by experienced physiotherapists and are adapted to each patient's physical abilities. Detailed handouts are distributed to each participants.
16111550|NCT02077036|Device|Kinetic Oscillation Stimulation Device|
16111551|NCT02077036|Device|Kinetic Oscillation Stimulation Device in placebo mode|
16111552|NCT02077010|Drug|Inhaled nebulized milrinone|inhaled nebulized milrinone 60mg/4ml
16111553|NCT02076997|Drug|Methotrexate|"Patients will receive 5g/m^2 high dose methotrexate as a 24 hour infusion.
~The methotrexate level in the blood will be checked at two times during the 24-infusion. The dose will be reduced based on the level in the blood."
16111554|NCT02076984|Procedure|Laparoscopic incisional or ventral hernia repair|
16111555|NCT02076958|Behavioral|Community Health Advisor education|
16111556|NCT02076945|Procedure|US-guided sciatic block at the popliteal crease (30 mL1:1 mixture of lidocaine 1% and bupivacaine 0.5%)|
16111557|NCT02076932|Behavioral|Spinning|After the baseline studies, the women will perform Spinning three times a week. Two of the sessions are performed on our location by trained instructors and the third training is self-training in a local fitness center where we provide free membership. All trainings are heart rate monitored.
16111558|NCT02076919|Drug|LHA510 Ophthalmic Suspension|Ophthalmic suspension in 4 concentration levels topically administered in Part 1 and Part 2
16111559|NCT02076919|Drug|LHA510 Vehicle|Inactive ingredients used for masking purposes
16111560|NCT02076906|Device|Magnetic Resonance High Intensity Focused Ultrasound|MR-High intensity focused ultrasound (HIFU) is an ultrasound based technology which allows for non-invasive thermal ablation of tumors under the guidance of MR thermography.
16112435|NCT02070458|Drug|cytarabine|Given IV
16111563|NCT02076893|Drug|Ibuprofen|Both study arms will receive as needed (PRN) ibuprofen to take home.
16111564|NCT02076893|Drug|Placebo|Simple syrup suspension
16111565|NCT02076880|Other|Caloric restriction|"Caloric restriction of 1000 kcal per day compared to the usual food intake.
~usual breakfast of the patient (possibly limited in quantity)
~midday and evening meals from mixed and dehydrated meals, soups with protein and dairy desserts sweetened"
16111566|NCT02076880|Other|No caloric restriction|No change in eating habits to patients in this arm
16111567|NCT02076867|Behavioral|Intensive Short-Term Dynamic Psychotherapy|The ISTDP model is an emotion focused brief format of psychotherapy that helps the patients identify and address emotional factors that culminate into exacerbation and perpetuation of somatic symptoms. Treatment will be provided according to manualized recommendations. The emphasis is on awareness of emotions and how they affect the person's behavioral patterns and somatic presentation. The research protocol calls for the treatment duration to be initially agreed at 8 weeks and then reviewed. Treatment should be delivered as a maximum 20-session time-limited format. The first session is an extended 2-3 hour appointment; then sessions are planned to occur on a weekly basis lasting 60 minutes in duration. Treatment progress is reviewed, specifically at sessions 4 and 8 to clarify the goal and objectives of further sessions. Patients are informed of the maximum treatment length. Termination in fewer sessions is based upon agreement between therapist and patient.
16111568|NCT02076867|Behavioral|Medical Care As Usual (MCAU)|This Medical Care As Usual (MCAU) was selected to control for both the role of emergency department care and family doctors care, as well as the passage of time and the natural emergence and reduction in symptoms before further intervention. Participants allocated to this group are advised that care will continue to be provided to them by the ED and they will be contacted with an appointment to see a therapist in 8 weeks should they so wish. They are advised to contact their family physician for routine care where necessary
16111569|NCT02076854|Behavioral|Text-Message Intervention|
16111570|NCT02076841|Device|interferon beta-1a|Administered as specified in the treatment arm
16111571|NCT02076828|Drug|Ferro Sanol® sp|The children with IDA that included in Fe-S (Ferro Sanol® sp.)(Group I) were treated with a therapeutic dose Ferro Sanol® sp as 6 mg/kg/day in the first 2 months and followed by maintenance treatment at a dosage of 2 mg/kg/day for the next 2 months.
16111572|NCT02076828|Drug|Santafer® sp.|The children with IDA that included in Fe-OH-PM (Santafer® sp.)(Group II) were treated with a therapeutic dose Santafer® as 6 mg/kg/day in the first 2 months and followed by maintenance treatment at a dosage of 2 mg/kg/day for the next 2 months.
16111573|NCT02076828|Drug|Ferro Zinc® sp|The children with IDA that included in Fe-Zn (Ferro Zinc® sp.)(Group III) were treated with a therapeutic dose Ferro Zinc® sp. as 6 mg/kg/day in the first 2 months and followed by maintenance treatment at a dosage of 2 mg/kg/day for the next 2 months.
16111574|NCT02076815|Drug|Anagrelide retard|Overencapsulated tablets or matched placebo, twice daily, 2-12 weeks titration to achieve stable platelet count, followed by 4 more weeks
16111575|NCT02076815|Drug|Thromboreductin|Overencapsulated capsule, twice daily, 2-12 weeks titration to achieve the stable platelet count, followed by 4 more weeks
16111576|NCT02076802|Behavioral|physical exercises|
16111577|NCT02076776|Behavioral|Repetitive Task Practice (RTP)|This group will preform arm and hand therapy.
16111578|NCT02076776|Behavioral|Voluntary cycling + RTP|This group will preform arm and hand therapy and cycle on a bike.
16111579|NCT02076776|Behavioral|Assisted cycling + RTP|This group will preform arm and hand therapy and cycle on a bike.
16111580|NCT02076750|Dietary Supplement|Vitamin D3 (cholecalciferol)|
16111581|NCT02076737|Device|Model-based iterative reconstruction (MB-IR VEOTM) on CT Discovery 750HD (GE Healthcare, Milwaukee, WI)|
16111582|NCT02076724|Device|Biological mesh|
16111583|NCT02076724|Device|Synthetic mesh|
16111584|NCT02076711|Drug|Metoprololsuccinate|
16111585|NCT02076711|Drug|Placebo|Placebo
16111586|NCT02076698|Procedure|AN-DBS|Electrode and one multichannel stimulator surgical time: 4 to 6 hours 3 visits of adjustment
16111587|NCT02076698|Drug|Usual treatment|usual treatment of epilepsy Vagus nerve stimulation: maintained
16111588|NCT02076685|Drug|isoniazid|dose adjustment according to the pharmacogenomic results
16111589|NCT02076672|Drug|Artichoke WPC|Artichoke WPC 500 mg capsules. Dose = 1000 mg (2 - 500 mg capsules) just before breakfast and 1000 mg (2 - 500 mg capsules) before dinner. Duration: daily for a period of 90 days.
16111590|NCT02076659|Drug|F8IL10|"Weekly administration of F8IL10 (from 6 to 600 μg/kg), starting from 6 μg/kg cohort 1. The cohort 10 represents the last dose-level of the study.
~F8IL10 will be administered as subcutaneous (s.c.) injections. Patients will receive 4 cycles of treatment unless there is unacceptable toxicity or withdrawal of consent."
16111591|NCT02076659|Drug|Methotrexate|"Methotrexate will be administered at a fixed dose of 10-15 mg on Day 1, orally (p.o.), subcutaneously (s.c.) or intramuscularly (i.m.).
~Patients will receive 4 cycles of treatment unless there is unacceptable toxicity or withdrawal of consent."
16111592|NCT02076646|Drug|L19IL2 - Ph I|During phase I part of the study, increasing dose of L19IL2 from one cohort to the next will be performed in steps of 160,000 IU/kg starting at 480,000 IU/kg (i.e., 0.48; 0.64; 0.80 MioIU/kg until MTD is reached).
16111593|NCT02076646|Drug|L19IL2 at RD - Ph II|L19IL2 at RD will be administered to Arm 1 patients during phase II part of the study.
16111594|NCT02076646|Drug|DTIC|Dacarbazine: 1 hour intravenous infusion on day 1 of each 21-cycle at a dosage of 1000 mg/m2 (fixed dose).
16111595|NCT02076633|Drug|L19IL2+L19TNF|Patients will be treated with intratumoral injections of 10 MioIU L19IL2 and 312μg L19TNF once weekly for up to 4 weeks.
16111596|NCT02076620|Drug|L19TNFα|L19TNFα will be administered as a 2 hours i.v. infusion on days 1, 3, and 5 of each 3-week cycle.
16111597|NCT02076620|Drug|Doxorubicin|Doxorubicin will be administered as a 15 minutes i.v. infusion on day 1 of each 3-week cycle prior L19TNFα administration.
16111598|NCT02076607|Procedure|Arthrodesis|Posterior approach to toracolumbar spine fusion.
16111599|NCT02076607|Device|Brace|Toracolumbar imobilization
16111600|NCT02076594|Drug|Docetaxel|Powder for solution for infusion
16111601|NCT02076594|Drug|Epirubicin|Solution for infusion
16111602|NCT02076594|Drug|Oxaliplatin|Powder for solution for infusion
16111603|NCT02076594|Drug|Capecitabine|Film coated tablets
16112635|NCT02068781|Dietary Supplement|Low-sodium diet|50 mmol NaCl per 24h
16111604|NCT02076568|Behavioral|Education - Diabetes and Partnership|"Based on the treatment and education programme PRIMAS a problem-specific education module regarding Diabetes and Partnership was created. The module covers specific and detailed aspects of the topic partnership such as dealing with hypoglycemia, late complications, and talking about diabetes in a relationship. With this module, a more comprehensive education of patients with specific interest in these topics is possible."
16111605|NCT02076555|Behavioral|Education - Diabetes and Social Issues|"Based on the treatment and education programme PRIMAS a problem-specific education module regarding Diabetes and Social Issues was created. The module covers specific and detailed aspects of the topic social issues such as driver licence, hypoglycemia when driving, and the pass for severly handicapped persons. With this module, a more comprehensive education of patients with specific interest is possible."
16111606|NCT02076542|Behavioral|Education - Diabetes and Sports|"Based on the treatment and education programme PRIMAS a problem-specific education module regarding Diabetes and Sports was created. The module covers specific and detailed aspects of the topic sports such as insulin reduction, hypoglycemia awareness during physical activity, and blood glucose values prior to physical activity. With this module, a more comprehensive education of patients with specific interest is possible."
16111607|NCT02076529|Drug|Ramosetron 0.3mg|
16111608|NCT02076529|Drug|Ramosetron 0.45mg|
16111609|NCT02076529|Drug|Ramosetron 0.6mg|
16111610|NCT02076516|Device|Drug-eluting stent: CORACTO®|
16111611|NCT02076503|Procedure|PET-MR 18f-FACBC|
16111612|NCT02076503|Procedure|histology (gold standard)|histopathological classification of co-located dissected lymph nodes
16111613|NCT02076490|Other|Physical/Occupational therapy|At least 10 individual sessions over the clinical intervention period of 4 weeks followed by a 6 weeks self-management phase.
16111614|NCT02076477|Radiation|concurrent chemoradiotherapy|Radiation（image-guided radiotherapy）：（1）primary tumors≤3cm，Hypofractionated radiation therapy，accumulated dose BED ≥80Gy （central lung cancer），BED ≥100Gy（Peripheral lung cancer）.（2）primary tumors>3cm，conventional fractionated radiotherapy，accumulated dose BED=60-66Gy/30-33f.（3） regional lymph node:conventional fractionated radiotherapy，accumulated dose BED=60-66Gy/30-33f.（4） Brain metastases： whole brain radiation therapy，36Gy/12f,Intracranial metastases，48Gy/12f.（5） bone metastasis：36 Gy/12f.
16111615|NCT02076477|Drug|Docetaxel|Docetaxel:60mg/m2 d1,Given IV
16111616|NCT02076477|Drug|pemetrexed|pemetrexed: 500mg/m2 d1,Given IV
16111617|NCT02076477|Drug|Cisplatin|Cisplatin：25mg/m2 d1-3，Given IV
16111618|NCT02076464|Behavioral|StudentBodies - Eating Disorders|The intervention is a structured, cognitive-behavioral guided self-help program, derived from manual-based cognitive-behavioral therapy. The intervention targets the core eating disorder pathology (e.g., extreme dietary restraint, overvaluation of shape and weight, binge eating, compensatory behaviors), focusing on helping users develop regular eating patterns, self-control strategies, problem-solving skills, and relapse prevention tools for maintenance of behavior change. The program includes daily symptom checklists, journal exercises and activities, and an asynchronous moderated online discussion group.
16111619|NCT02076451|Drug|DS-8273a|DS-8273a will be administered as an intravenous (IV) solution. Subjects will receive DS-8273a on Day 1 of a 21 day cycle (once every 3 weeks
16111620|NCT02076438|Dietary Supplement|Probiotics|Randomized to receive probiotics or placebo
16111621|NCT02076425|Behavioral|PCIT-ED|
16111622|NCT02076412|Drug|Fostamatinib Disodium|Fostamatinib Disodium tablet 100 mg or 150 mg PO bid (morning and evening) over the course of 24 weeks.
16111623|NCT02076412|Drug|Placebo|Placebo tablet PO bid (morning and evening)
16111624|NCT02076399|Drug|Fostamatinib disodium|Fostamatinib (100 mg PO bid or 150 mg PO bid)
16111625|NCT02076399|Drug|Placebo|Placebo tablet PO bid (morning and evening) over the course of 24 weeks
16111626|NCT02076386|Drug|Dolutegravir|Prospective, non-interventional study of the use of doluetegravir as part of an antiretroviral combination therapy in routine daily practice in Germany. No drug will be provided. No study visits or procedures are mandated per protocol.
16111627|NCT02076373|Drug|recombinant human Erythropoietin|i.v. administration
16111628|NCT02076373|Drug|Placebo|i.v. administration
16111629|NCT02076360|Behavioral|Preoperative Video|Patients will watch preoperative instructional video
16111630|NCT02076347|Behavioral|Office visit intervention|Pharmacist communicates monitoring recommendations to physician through the electronic medical record prior to a scheduled patient office visit
16111631|NCT02076347|Behavioral|Electronic Message Intervention|Pharmacist communicates need for monitoring directly to patients and instructs them to obtain monitoring on their own time without need for an office visit with physician
16111632|NCT02076334|Other|Far Infrared Fabric|
16111633|NCT02076334|Other|Spandex|
16111634|NCT02076321|Drug|Acetaminophen|acetaminophen for pain control with dose and frequency of 10-15mg/kg/dose, Maximum dose 1000mg. Maximum amount per day: 75mg/kg (not to exceed 4g/day).
16111635|NCT02076321|Drug|Ibuprofen|ibuprofen for pain control with dose and frequency 4-10mg/kg/dose. Maximum of 40mg/kg/day, not to exceed 3,200mg/day. Maximum one-time dose of 800mg.
16111636|NCT02076308|Other|Electroacupuncture and physical therapy|real electroacupuncture
16111637|NCT02076308|Other|Sham-electroacupuncture and physical therapy|Sham electroacupuncture
16111638|NCT02076282|Other|1 MRI scan|"For healthy volunteers: 1 MRI scan without contrast
~For patients: 1 MRI scan with contrast"
16111639|NCT02076269|Other|No Intervention|Patients are receiving no treatment in this study and there is no investigational product involved
16111640|NCT02076256|Behavioral|The helping relationships intervention program|
16111641|NCT02076243|Drug|nab-paclitaxel|nab-paclitaxel (abraxane) administered weekly (days 1,8, and 15 of 28 day cycle) to patients with unresectable locoregional or distantly metastatic cutaneous squamous cell carcinoma (SCC).
16111642|NCT02076230|Drug|[14C] TH-302 (Label 1)|[14C]-labeled TH-302 (Label 1) will be administered as intravenous infusion over 30 minutes on Day 1 of Part A.
16111643|NCT02076230|Drug|[14C] TH-302 (Label 2)|[14C]-labeled TH-302 (Label 2) will be administered as intravenous infusion over 30 minutes on Day 1 of Part A.
16111778|NCT02075125|Drug|Prasugrel 60 mg|Patient administer prasugrel 60 mg as loading dose followed by 10 mg/day as maintenance dose.
16111644|NCT02076230|Drug|Unlabeled TH-302|Unlabeled TH-302 will be administered along with labeled TH-302 at the dose of 340 milligram per square meter (mg/m^2) as intravenous infusion over 30 minutes on Day 1 of Part A, followed by recommended Phase 2 dose (RP2D) of 480 mg/m^2 as monotherapy infusion over 30 minutes on Days 8 and 15 of Part A; and on Days 1, 8 and 15 of Part B, until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow up, or death.
16111645|NCT02076217|Drug|Copper T-380 IUD|
16111646|NCT02076217|Drug|LNG IUD|
16111647|NCT02076217|Device|Contraceptive implant Nexplanon|
16111648|NCT02076217|Drug|Depo-Provera|
16111649|NCT02076204|Behavioral|Home visiting|MIHOPE-Strong Start will examine local programs that use either of two home visiting service models that have shown previous evidence of improving birth outcomes: Healthy Families America (HFA) and Nurse-Family Partnership (NFP). HFA and NFP provide disadvantaged expectant mothers with individualized in-home services, including assessment of prenatal and postnatal risks to child well-being; referrals to needed health care or social services; and direct education of parents by home visitors on such topics as healthy prenatal behaviors, parenting, and child development.
16111650|NCT02076191|Drug|Ruxolitinib|Ruxolitinib will be administered at doses of 5mg, 10mg, 15mg, or 25 mg taken orally every 12 hours throughout the treatment cycle.
16111651|NCT02076191|Drug|Decitabine|Decitabine is administered intravenously at a dose of 20 mg/m2 daily for 5 days. Subsequent cycles of decitabine may be administered at 4 week intervals as clinically tolerated. Decitabine treatment may be deferred for up to 2 weeks to allow recovery from non-hematologic toxicity during the first 6 cycles and up to 2 weeks thereafter for hematologic toxicities as well. The first treatment cycle will last 35 days and will be the evaluable period for DLTs and RPTD determination for patients enrolled in the phase I portion only. Subsequent treatment cycles will be 4-6 weeks in duration as defined by decitabine administration.
16111652|NCT02076178|Drug|744 Tablet|White to almost white oval shaped film coated 30 mg tablets for oral administration
16111653|NCT02076178|Drug|744 LA Injection|Sterile white to slightly coloured suspension containing 200 mg/mL of 744 as free acid for administration by intramuscular (IM) injection
16111654|NCT02076178|Drug|Placebo Tablet|Microcrystalline cellulose, Opadry film-coating, white OY-S-28876
16111655|NCT02076178|Drug|Placebo Injection|Sterile saline 0.9% Sodium Chloride Injection
16111656|NCT02076165|Behavioral|Acceptance and the Behavioral Changes to Treat Insomnia|Participants attended 5 individual sessions incorporating behavioral treatment components plus acceptance and commitment therapy (ACT) with a trained instructor.
16111657|NCT02076165|Behavioral|Cognitive behavioral therapy for insomnia|Participants attended 5 individual sessions incorporating behavioral and cognitive therapy components with a trained instructor.
16111658|NCT02076152|Device|FMISO PET|
16111659|NCT02076152|Device|MRI|"MR scans will be performed with the same sequences and in the same order during each visit, including T1- and T2-weighted volumetric images, fluid attenuated inversion recovery (FLAIR), contrast agent enhanced T1-weighted permeability, diffusion tensor imaging (DTI), T2/T2*-weighted perfusion scans, and MR Spectroscopy. The Autoalign package available from the manufacturer will be used to achieve the same slice prescription in the same patient at each visit. Each MRI will last 60-75 minutes versus 45 minutes for standard brain MRIs."
16111660|NCT02076152|Drug|Bevacizumab|A cycle is defined as 28 days (1 month). The study duration is 12 months (12 cycles). Patients will be treated after 12 months or at the time of progression per discretion of their responsible physician.
16111661|NCT02076152|Drug|CCNU|A cycle is defined as 28 days (1 month). The study duration is 12 months (12 cycles). Patients will be treated after 12 months or at the time of progression per discretion of their responsible physician.
16111662|NCT02076139|Dietary Supplement|Nyaditum resae® 10e4|
16111663|NCT02076139|Dietary Supplement|Nyaditum resae® 10e5|
16111664|NCT02076139|Other|Distilled water|
16111665|NCT02076113|Procedure|Ventral (Front) decompression with Fusion|Ventral decompression and fusion will be performed using a multi-level discectomy (including partial or single level corpectomy) with fusion and plating. Allograft will be used at each disc space and all compressive osteophytes will be removed using the operating microscope. Fixation will be performed with rigid, semi-constrained, or dynamic titanium plates to optimize fusion and minimize complications.
16111666|NCT02076113|Procedure|Dorsal (Back) Decompression with Fusion|Dorsal decompression and fusion will be performed using midline cervical laminectomy with the application of lateral mass screws and rods for rigid fixation. All surgeons will use local bone and allograft as needed to perform a lateral mass fusion, which typically will include one level rostral to the levels decompressed.
16111667|NCT02076113|Procedure|Dorsal (back) Laminoplasty|Laminoplasty will be performed using an open-door approach with the application of plates and screws at each treated level. Ceramic or allograft laminar spacers (surgeon's choice) can be used with plates and screws to expand the canal diameter.
16111668|NCT02076100|Drug|Ruzasvir|Ruzasvir capsules, orally, starting at a dose of 60 mg once per day (QD) x 5 days with doses increasing or decreasing as clinically indicated.
16111669|NCT02076087|Procedure|Liposuction/lipectomy|Subcutaneous adipose tissue will be obtained from liposuction/lipectomy to determine the types of immune cells
16111670|NCT02076074|Radiation|accelerated partial breast irradiation|Undergo HG-PBI
16111671|NCT02076022|Device|Enhanced Fat Grafting|"The stromal vascular fraction (SVF) cell suspension (device output) will be processed using the Tissue Genesis Cell Isolation System™
~The Standard graft material and the stromal vascular fraction cells will be mixed and subsequently injected into the amputated stump at a concentration of 2.0 - 3.0 x 10 6 stromal vascular cells/ml of injected fat graft to each site. The volume of each injected fat graft will depend on the volume requirements for each injured extremity.
~To manually combine the standard fat graft material and the SVF suspension (device output), each of the syringes will be connected via luer to luer lock. The contents of the lipoaspirate syringe are transferred to the SVF syringe and the cell suspension will be injected slowly back and forth between the two (2) syringes. The final 1 mL SVF-fat graft syringe is now considered cell-enriched and ready for injection into the subject."
16111716|NCT02075658|Device|Conventional Insufflator and Trocar|Conventional insufflator and trocars are used in standard procedures and will serve as the base for comparison of the study device (AirSeal® System).
16111779|NCT02075125|Drug|Ticagrelor 180 mg|Patients administer ticagrelor 180 mg as loading dose followed by 90 mg bid as maintenance dose.
16111672|NCT02076022|Procedure|Standard fat graft|Aspirated fat tissue will be processed as standard graft material. It will be divided into small aliquots and centrifuged in a sterile rotor (3000 rpm for 3 minutes/1200g), and top fluid oil layer from the fat tissue fractions were removed, and transferred into 1ml syringes and injected into the amputation stump. This graft preparation will be performed in the operating room. Standard fat graft material will serve as a control treatment and will be injected into limb using specialized injection cannulas
16111676|NCT02075983|Biological|GTU®-multiHIV B clade|The investigational HIV-1 vaccine GTU®-MultiHIV B clade encodes for a MultiHIV antigen (synthetic fusion protein built up by full-length polypeptides of Rev, Nef, Tat, p17 and p24 with more than 20 Th and CTL epitopes of protease, reverse transcriptase (RT) and gp160 regions of the HAN2 HIV-1 B clade.
16111677|NCT02075970|Drug|Epoetin Alpha|"Infant study 1: VLBW infant study subjects (weighing 1.0 to 1.5 kg at birth) who are otherwise receiving standard clinical care will be treated with Epoetin Alpha according to a dosing algorithm.
~Infant study 2:
~Dosing algorithm will be determined by results of Infant Study 1."
16111678|NCT02075970|Drug|Biotinylated Red Blood Cells|Biotinylated red blood cells will be transfused to infants to determine red blood cell lifespan.
16111679|NCT02075944|Behavioral|High intensity aerobic exercise|
16111680|NCT02075944|Behavioral|Low intensity aerobic exercise|
16111681|NCT02075931|Other|Physical activity feedback with group meetings|Physical activity feedback
16111682|NCT02075931|Other|Control|No intervention
16111683|NCT02075892|Dietary Supplement|Mushroom Blend|Scivation
16111684|NCT02075892|Dietary Supplement|Placebo|
16111685|NCT02075879|Behavioral|Nurse-led interviewing|Participants in experimental arm received regular face-to-face interviews during dialysis sessions conducted by the designated case managers every week for 6 weeks and biweekly for another 6 weeks.
16111686|NCT02075879|Other|Brief group exercise|Participants in this arm only participated in the brief in-center exercise training. They received usual care from the nurse without the interviews and mutual goals developed.
16111687|NCT02075840|Drug|Alectinib|Participants will receive alectinib 600 mg orally (four 150 mg capsules) BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
16111688|NCT02075840|Drug|Crizotinib|Participants will receive crizotinib 250 mg capsules orally BID from Visit 0 (baseline) until disease progression, unacceptable toxicity, withdrawal of consent or death.
16111689|NCT02075827|Behavioral|Competitive video game|1 hour playing video game
16111690|NCT02075827|Behavioral|Little Big Planet|1 hour playing video game
16111691|NCT02075801|Other|Sealing of amalgam margin defects|Comparison between sealing of amalgam margins defects, replacement and non treated groups.
16111692|NCT02075801|Other|Sealing of amalgam margin defects|"A.Sealing of amalgam margin defects: were acid etched with 35% phosphoric acid for 15 seconds. A resin-based sealant (Clinpro Sealant, 3MESPE) was applied over the defective area. The sealant was polymerized with a photocuring unit (Curing Light 2500, 3M ESPE) for 40 seconds. Rubber dam isolation was used for this procedure. All treatments were applied by the same clinician.
~B.Replacement Group: The clinician totally removed and replaces the defective restoration with a new amalgam (Tytin, Kerr Corporation, Orange, CA, USA). Rubber dam isolation was used for this procedure. All treatments were applied by the same clinician.
~C.Control Group: The defective restorations did not receive any treatment."
16111693|NCT02075788|Other|Commercial white bread|
16111694|NCT02075788|Other|Corn based products (porridge etc.)|
16111695|NCT02075788|Other|Millet based products (porridge etc.)|
16111696|NCT02075762|Procedure|Transbronchial biopsy|
16111697|NCT02075762|Procedure|Cryoprobe biopsy|
16111698|NCT02075762|Procedure|VATS biopsy|
16111699|NCT02075749|Drug|Triamcinolone Acetonide|
16111700|NCT02075749|Drug|licorice mucoadhesive films|30 patients received licorice mucoadhesive films
16111701|NCT02075736|Procedure|KTP laser|
16111702|NCT02075736|Procedure|TUR-P|device
16111703|NCT02075723|Dietary Supplement|Overfeeding (130 % of energy requirements )|Overfeeding (130 % of energy requirements )
16111704|NCT02075723|Behavioral|Sleep restriction (4 hours per night)|Sleep restriction (4 hours per night)
16111705|NCT02075710|Other|High sugar/meal feed|Weight-maintaining diet relatively high in sugar fed as two large meals daily
16111706|NCT02075710|Other|High sugar/nibble|Weight-maintaining diet relatively high in sugar fed as 8 meals daily
16111707|NCT02075710|Other|High fat/meal feed|Weight-maintaining diet relatively high in fat fed as two large meals daily
16111708|NCT02075710|Other|High fat/nibble|Weight-maintaining diet relatively high in fat fed as 8 small meals daily
16111709|NCT02075710|Other|High sugar/ 3 meals a day|Weight-maintaining diet relatively high in sugar fed as 3 meals daily
16111710|NCT02075710|Other|High fat/ 3 meals a day|Weight-maintaining diet relatively high in fat fed as 3 meals daily
16111711|NCT02075684|Procedure|Renal Biopsy|
16111712|NCT02075671|Drug|Aminolevulinic acid topical solution 20%|Intervention used in the experimental arm only
16111713|NCT02075671|Device|Blu-U Light Therapy|Intervention used in experimental and sham arms
16111714|NCT02075671|Other|Placebo vehicle only|Intervention only includes the placebo vehicle solution
16111715|NCT02075658|Device|AirSeal® System-Interventional|The AirSeal® System consists of an insufflation, filtration, and recirculation system (AirSeal® IFS), a triple lumen filtered tube set, and a valve free trocar (AirSeal® Access Port). The device enables peritoneal access with a novel mechanism to maintain pneumoperitoneum without a mechanical seal.
16111717|NCT02075645|Other|Team training course|"A 1-day simulation-based team-training course. There will be 4 simulated resuscitation events. Simulation #1 will be the pre-course team performance and simulation #4 will be the post-course performance."
16111718|NCT02075632|Drug|Alclometasone dipropionate cream|Alclometasone dipropionate cream 0.05% (15 g)
16111719|NCT02075619|Drug|Amlodipine+Rosuvastatin|Amlodipine 10mg will be supplied as white or off-white, emerald shaped tablet. Rosuvastatin 20mg will be supplied as pink round film coated tablet.
16111720|NCT02075619|Drug|GSK3074477 FDC - 1|GSK3074477 containing combination of 10mg amlodipine and 20mg rosuvastatin, will be supplied as white caplet shaped film coated tablet.
16111721|NCT02075619|Drug|GSK3074477 FDC - 2|GSK3074477 containing combination of 10mg amlodipine and 20mg rosuvastatin, will be supplied as white caplet shaped film coated tablet.
16111722|NCT02075606|Drug|lanreotide acetate|Somatuline Autogel injection 120mg for first 3 months then 120, 90 or 60 mg administered via the deep subcutaneous route every 28 days
16111724|NCT02075580|Behavioral|psychological support (interactive/cognitive strategies)|"cognitive/behavioural intervention (6 times starting from hospital admission, in 90 days; for arm of intervention)
~metacognitive techniques (6 times starting from hospital admission, in 90 days; for arm of intervention)
~psychoeducational intervention (6 times starting from hospital admission; for arm of intervention)
~questionnaires: EORTC questionnaires and a written structured interview (3 times: hospital admission,15 days after surgical intervention, 90 days after intervention; in both arms)"
16111725|NCT02075567|Procedure|Experimental|
16111726|NCT02075554|Device|CALIBER|Expandable interbody spacer
16111727|NCT02075541|Biological|NTHi-10-AS01E|Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
16111728|NCT02075541|Drug|NaCl Placebo|Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
16111729|NCT02075528|Drug|Paliperidone ER|9 mg/d of paliperidone ER was administered during the first 2 weeks, after which the dose was adjusted clinically
16111730|NCT02075515|Biological|Herpes Zoster vaccine (GSK 1437173A)|2 doses administered intramuscularly in deltoid region of non-dominant arm.
16111731|NCT02075502|Behavioral|Exercise therapy|The exercise therapy program with training, monitoring and coaching enhanced by community-based participatory research (CBPR) (TMC+) is a comprehensive approach to community-based walking exercise for improving PAD patient outcomes. The components of TMC+ are optimal training guidelines for patients (i.e., T), monitoring from both investigators and patient self-monitoring (i.e., M), coaching from investigators on how to improve patients' walking ability (i.e., C), and finally enhancements from CBPR practices (+).
16111732|NCT02075502|Procedure|lower extremity ET|catheter-based revascularization of peripheral arteries (background treatment part of standard clinical care at hospital)
16111733|NCT02075502|Procedure|peripheral open intervention|revascularization of lower extremities with open bypass surgery (background treatment part of standard clinical care at hospital)
16111734|NCT02075489|Other|Acupressure treatment.|Acupressure will be provided 40 min/day, 2 days/week for 6 weeks (total of 12 sessions). Symptomatic veterans will receive standardized acupressure treatment for ~5 s on each acupoint until the subject gets the sense of soreness and numbness, and the procedure will be repeated three times. Kneading massage will be applied around eyes and forehead, and face will be swabbed by palm for ~ 5 min. Manipulation of these acupoints is aimed at helping to calm and ease the subject, lighten headache and migraine, relieve fatigue, and alleviate insomnia.
16111735|NCT02075489|Other|Reiki|Veterans in the control group will receive reiki treatment with the same dosage (40 min/session, 12 sessions in 6 wks). The practitioner will place his/her hands on the recipient in various positions covering head, the back of the torso, and the 4 limbs with fixed set of 12 hand positions. These covered areas will then be tapped and stroked, and practitioner will focus his/her gaze on these areas for 2-3 min, through which the healing energy is transferred to the subjects. In a format similar to acupressure treatment, it will be used as an inert control treatment to balance additional care the experimental group will receive.
16111736|NCT02075476|Procedure|Hemiarthroplasty|
16111737|NCT02075476|Procedure|reverse arthroplasty|
16111738|NCT02075463|Drug|GSK1278863|Film coated tablets containing 1 mg, 2 mg, 5 mg or 25 mg of GSK1278863
16111739|NCT02075463|Drug|Placebo|Matching placebo tablet for GSK1278863
16111740|NCT02075450|Device|CPRcard|CPR Card in place during chest compressions to provide immediate visual feedback.
16111741|NCT02075450|Other|Just in Time Video|CPR Just in Time training video administered before the simulation case
16111742|NCT02075437|Behavioral|Feeling and Body Investigators with Functional Abdominal Pain|"Investigator's ten session intervention trains children to be Feeling and Body Investigators. Half of the sessions will be done in clinic and half at home via web-camera to facilitate generalization. During the treatment child/caregiver dyads will 1) gather body clues (Learn), 2) investigate (Experience: perform interoceptive mystery missions to explore a body sensation), 3) organize body clues (Contextualize: recall other context that evoke similar sensations), and 4) go on increasingly daring missions (Challenge: decrease avoidance and safety behaviors).
~If successful, young children with FAP who complete the FBI early intervention will learn to experience changes in the viscera as fun and fascinating, rather than scary, and will develop new capacities for pain management, adaptive functioning, and emotion regulation."
16111743|NCT02075437|Behavioral|Treatment Strategies|"identify strategies with unique patterns of neural circuit maturation associated with early visceral pain on the gut-brain axis:
~adapt acceptance-based behavioral strategies used to address psychopathology in older children to younger children;
~incorporate caregivers as role models and facilitators based on attachment research."
16111773|NCT02075177|Drug|Fenretinide Lym-X-Sorb Oral Powder|Fenretinide Lym-X-Sorb 1500 mg/m2/day, daily for 7 days every 3 weeks
16111774|NCT02075177|Drug|Ketoconazole|Ketoconazole 6 mg/kg/day, daily for 7 days every 3 weeks.
16111775|NCT02075164|Dietary Supplement|Fructose|High oral Fructose challenge (150g per day for 56 days)
16111776|NCT02075164|Dietary Supplement|Glucose|Dietary Supplement: High oral Fructose challenge (167g per day for 56 days)
16111777|NCT02075151|Procedure|Bronchial Thermoplasty|Bronchial thermoplasty
16111744|NCT02075424|Other|salivary sampling by a biomnis swab|"Each call operator will have a series of salivary sampling taken when assigned to call reception, to the unit deployment station and to the assessment station.
~Only one sampling will occur to doctors who are assigned to a single workstation.
~Sampling will be taken every 15 minutes during one hour and half and one last sample will be taken 2 hours after the call.
~To improve interpretation of the results, a series of control-samples will be taken among the call operators and doctors during a day off and not during a security break.
~There will be 4x8 samples taken for each call operator and 2x8 samples per doctor.
~They will also be frozen at a temperature of -4°C and sent to the laboratory of the CHR Metz Thionville."
16111745|NCT02075411|Drug|bupivacaine|"Adolescent males receive the single shot femoral and sciatic nerve blocks prior to ACL repair.
~Males Single shot peripheral nerve block"
16111746|NCT02075411|Drug|bupivacaine|"Adolescent females receive the single shot femoral and sciatic nerve blocks prior to ACL repair.
~Females Single shot peripheral nerve block"
16111747|NCT02075411|Device|continuous perineural infusion catheter|Adolescent males receive the continuous peripheral nerve block infusion catheter prior to ACL repair.
16111748|NCT02075411|Device|continuous perineural infusion catheter|Adolescent females receive the continuous peripheral nerve block infusion catheter prior to ACL repair.
16111749|NCT02075385|Procedure|pre, during and pos-treatment swallowing exercises|Speech pathology therapy
16111750|NCT02075372|Other|Data registration|Patients diagnosed with the presence of one or more chronic total occlusions (CTOs) and who will receive treatment via percutaneous coronary intervention (PCI), which is standard medical practice for these types of lesions. This study will collect data on the patients' demographics, CTO characteristics, procedure and outcome. This will be done in the form of a registry
16111751|NCT02075333|Dietary Supplement|Ingestion of solution|Participants will ingest the solution
16111752|NCT02075333|Dietary Supplement|Rinising of solution|Participants rinse the solution in the oral cavity
16111753|NCT02075320|Device|Stationary Digital Chest Tomosynthesis|"The study scan, s-DCT, will be performed within two weeks of his/her clinical evaluations by chest CT and CR. There cannot be any intervening therapies or procedures (i.e. biopsy or excision of lesions) done in between the SOC imaging and the s-DCT. In the event that CRs are not included in the SOC imaging or are unusable (outside of acceptable window or poor quality), the scout image acquired by CT will be used in place of a CR.
~Images will be acquired by a trained radiologist technologist. The technologist will comfortably position the patient in the supine position on the imaging table. Then, all patients will have a breath held s-DCT scan in an anterior-posterior direction."
16111754|NCT02075307|Dietary Supplement|Blueberry Powder|
16111755|NCT02075307|Dietary Supplement|Placebo|
16111756|NCT02075294|Drug|Adefovir dipivoxil or Entecavir|"Adefovir tablet, 10mg, take orally, once per day, more than 3years, exact duration depend on specific conditions and guidelines.
~Entecavir tablet, 0.5mg, take orally, once per day, more than 3years, exact duration depend on specific conditions and guidelines"
16111757|NCT02075281|Biological|HM11260C|Glucagon-like peptide-1 analogue
16111758|NCT02075281|Biological|Placebo|
16111759|NCT02075268|Drug|prasugrel|prausugrel 10 or 30 mg will be administrated as single dose under overnight fast.
16111760|NCT02075255|Biological|Benralizumab|Benralizumab administered subcutaneously every 4 weeks
16111761|NCT02075255|Biological|Placebo|Placebo subcutaneously on study week 0 until study week 24 inclusive.
16111762|NCT02075255|Biological|Benralizumab|Benralizumab administered subcutaneously every 4 weeks for the first 3 dose and then every 8 weeks; matching placebo subcutaneously at the 4 week interim to maintain the blind.
16111763|NCT02075242|Drug|Mycophenolate Mofetil|experimental group receive Tacrolimus as a main immunosuppressants and assistant is My-rept capsule®(Mycophenolate Mofetil),
16111764|NCT02075242|Drug|Tacrolimus|control group receive same immunosuppressants except for My-rept capsule®(Mycophenolate Mofetil- investigational product
16111765|NCT02075229|Device|Cochlear implant|A cochlear implant consists of an implantable device that electrically stimulates surviving nerve fibers within the inner ear to produce perceptions of sound in patients with significant sensorineural hearing loss.. The implanted device is controlled by an external sound processor that converts acoustic sound signals into patterns of electrical stimulation that result in sound perception for the user.
16111766|NCT02075216|Procedure|Myoblast Transplantation|For each patient 4-7 Million cells per ml will be injected into 8 to 10 sites through a cystoscopic injection needle with a 10 mm long, 21 gauge needle connected to a 30 cm long plastic tube, using a 6.75Fr neonatal cystourethroscope. The suspension will be injected in the area of the external sphincter and along the posterior urethra proximal to the verumontanum, aiming to attain visual occlusion of the urethral lumen.
16111767|NCT02075216|Biological|Neonatal Cystourethroscope Injection|4-7 Million cells per ml will be injected into 8 to 10 sites through a cystoscopic injection needle with a 10 mm long, 21 gauge needle connected to a 30 cm long plastic tube, using a 6.75Fr neonatal cystourethroscope.
16111768|NCT02075203|Biological|AERAS-404|The H4 antigen is a fusion protein created from two Mtb antigens: antigen Ag85B and TB10.4. Ag85B is also referred to as α-antigen and is a 30-kDa mycolyl transferase protein. TB10.4 is one of three members of the very similar ESAT-6 group of proteins found in Mtb culture supernatants. TB10.4 induces broad immune responses in T cells isolated from TB subjects compared to BCG-vaccinated donors and unvaccinated donors. IC31 is a combination of a leucine-rich peptide named KLK & a synthetic oligonucleotide named ODN1a. The optimal molar ratio of KLK to ODN1a in mice is 25:1. AERAS-404 & saline placebo trial arms will be double-blinded since BCG causes a recognizable local injection site reaction, the BCG revaccination trial arm will be unblinded.
16111769|NCT02075203|Drug|Placebo|Saline
16111770|NCT02075203|Biological|Bacillus Calmette-Guérin (BCG)|BCG SSI Vaccine is registered in South Africa for prevention of TB in children and adults. BCG, an attenuated, live culture of the Bacillus Calmette-Guérin, was originally attenuated between 1906 and 1919 by serial passage of an M. bovis strain. The manufacturer Statens Serum Institut (SSI) in Copenhagen, Denmark derives this vaccine from the Danish BCG strain 1331. BCG SSI is supplied by the manufacturer in amber 10-dose vials containing 0.75 mg lyophilized SSI BCG. The BCG revaccination trial arm will be unblinded (open label).
16111771|NCT02075190|Other|Therapeutic Computerized intervention|Remediation training intervention
16111772|NCT02075190|Other|Nontherapeutic computerized intervention|Online gaming intervention
16113407|NCT02062632|Other|Placebo|Given orally
16111780|NCT02075112|Drug|Soy isoflavone|Patients will receive genistein 150 mg daily for the duration of radiation treatment. If a patient is experiencing significant side effects attributable to genistein, the treating physician has the option to reduce genistein to 150 mg every other day.
16111781|NCT02075112|Radiation|Radiation|All patients will undergo computed tomography (CT) simulation with intravenous (IV) contrast unless medical contraindications to IV contrast exist. Gross disease will be treated to 70 Gy in 2 Gy/day.
16111782|NCT02075112|Drug|Cisplatin|Cisplatin chemotherapy 100 mg/m² on days 1, 22, and 43 of radiation treatment.
16111783|NCT02075099|Other|tensing exercises|Donors will do tensing exercises during blood donation
16111784|NCT02075099|Other|No tensing exercises|Donors will not do tensing exercises during blood donation - control arm
16111785|NCT02075086|Drug|Xelox or Xeliri Bevacizumab|Chemotherapy treatment
16111786|NCT02075073|Biological|SB3|
16111787|NCT02075073|Biological|EU sourced Herceptin®|
16111788|NCT02075073|Biological|US sourced Herceptin®|
16111789|NCT02075060|Procedure|IPOI (pre-operative)|
16111790|NCT02075060|Procedure|IPOP (post-operative)|
16111791|NCT02075047|Drug|placebo oral capsules|Placebo matching the oral ziprasidone capsules of 20,40, 60 and 80 mg in strength. Subjects will be dosed for 4 weeks using a flexible dosing design. Dosing is stratified based on weight, with subjects <45 kg having a target dose range of 60-80 mg/day and subjects >/= 45 kg having a target dose range of 120-180 mg/day.
16111792|NCT02075047|Drug|ziprasidone oral capsules|Oral ziprasidone capsules of 20,40, 60 and 80 mg in strength. Subjects will be dosed for 4 weeks using a flexible dosing design. Dosing is stratified based on weight, with subjects <45 kg having a target dose range of 60-80 mg/day and subjects >/= 45 kg having a target dose range of 120-180 mg/day.
16111793|NCT02075034|Drug|rigosertib|Rigosertib will be supplied as soft gel capsules in strengths of 280 mg and 70 mg.
16111794|NCT02075021|Drug|Lenalidomide|
16111795|NCT02075021|Drug|nab-paclitaxel|
16111796|NCT02075008|Drug|QGE031|QGE031 120 mg/mL solution for subcutaneous injection
16111797|NCT02074995|Biological|BVS857|Group 1A&1B receive first dose as IV then remaining doses as SC. Groups 2, 3 and 4 receive only SC doses.
16111798|NCT02074995|Other|placebo|Group 1B receive first dose as IV then remaining doses as SC. Groups 2, 3 and 4 receive only SC doses.
16111799|NCT02074982|Drug|AIN457 300 mg|
16111800|NCT02074982|Drug|ustekinumab 45/90 mg|
16111801|NCT02074982|Drug|placebo secukinumab|Placebo
16111802|NCT02074969|Device|Gamma Nail 3|Patients who have sustained an unstable pertrochanteric hip fracture are getting treated by Gamma Nail 3.
16111803|NCT02074969|Device|PFNA|Patients who have sustained an unstable pertrochanteric hip fracture are getting treated by PFNA.
16111804|NCT02074956|Biological|AERAS-404|AERAS-404 is comprised of the H4 antigen, a fusion protein of Mycobacterium tuberculosis antigens 85B and TB10.4; and IC31 adjuvant, a combination of a leucine-rich peptide and a synthetic oligonucleotide.
16111805|NCT02074956|Biological|Placebo|Sterile buffer containing 10 mmol Tris and 169 mmol of NaCl in 0.8 mL of aqueous solution. This is the identical buffer solution in which H4 and IC31 are formulated.
16111806|NCT02074943|Biological|PRP|PRP will be inject to half head. The other half will be injected with normal saline.
16111807|NCT02074930|Device|Microporation by P.L.E.A.S.E. Professional / Prick needle|
16111808|NCT02074917|Procedure|Anatomical ACL reconstruction|Anatomical anterior cruciate ligament reconstruction in the anteromedial or central tunnels positions.
16111809|NCT02074904|Drug|Topiramate|
16111810|NCT02074904|Drug|Placebo|
16111811|NCT02074891|Drug|coformulated TDF/FTC|Daily oral dose of coformulated TDF/FTC
16111812|NCT02074878|Drug|Crixotinib 200 mg and Sunitinib Cohort 1|Crizotinib 200 mg, twice daily with Sunitinib 25.0 mg once a day
16111813|NCT02074878|Drug|Crixotinib 250 mg and Sunitinib Cohort 2|Crizotinib 250 mg, twice daily with Sunitinib 25.0 mg once a day
16111814|NCT02074878|Drug|Crizotinib & Sunitinib 37.5 mg Cohort 3|Crizotinib 250 mg, twice daily with Sunitinib 37.5 mg once a day
16111815|NCT02074865|Biological|biological samples|
16111816|NCT02074852|Other|Foley urethral catheter|
16111817|NCT02074839|Drug|AG-120|AG-120 administered continuously as a single agent dosed orally every day of a 28-day cycle. Subjects may continue treatment with AG-120 until disease progression, development of other unacceptable toxicity or hematopoietic stem cell transplant.
16111818|NCT02074813|Other|Inspiratory muscle training|Inspiratory muscle training
16111819|NCT02074800|Drug|CNTO 328 (Sp2/0-derived)|Participants will receive a single-dose of Sp2/0-derived CNTO 328 intravenously (into the vein) either 1.4 or 2.8 mg/kg in Part 1 and 1.4 mg/kg in Part 2.
16111820|NCT02074800|Drug|CNTO 328 (CHO-derived)|Participants will receive a single-dose of CHO-derived CNTO 328 intravenously (into the vein) either 1.4 or 2.8 mg/kg in Part 1 and 1.4 mg/kg in Part 2.
16111821|NCT02074800|Drug|Placebo|Participants will receive a single-dose of matching placebo intravenously in Part 1.
16111822|NCT02074787|Device|Thermography|Standard thermographic images
16111823|NCT02074787|Device|Laser Doppler|standard laser doppler analysis
16111824|NCT02074787|Device|Spectrophotometric Intracutaneous analysis|standard SIA scope imaging
16111825|NCT02074774|Device|IntellO2|Automated FiO2 regulator that responds to pulse oximetry measures
16111826|NCT02074774|Other|Manual control|Standard practice of manually titrating FiO2 as needed.
16111827|NCT02074761|Device|SImmetry|"The SImmetry device is commercially available. The implanted devices consist of a range of threaded, self-tapping, cannulated implants designed to transfix the sacrum and ilium, providing stability for intra-articular fusion.
~The SImmetry Surgical Instruments include standard manual surgical instruments used to access and prepare the sacroiliac joint space for intra-articular fusion."
16111828|NCT02074735|Drug|Placebo|Inactive ingredient matching the active comparator in appearance
16111829|NCT02074735|Drug|Citicoline|Citicoline is an over-the-counter nutritional supplement that is used for neuroprotective effects. It is a naturally occurring neurochemical in the human body.
16111857|NCT02074514|Drug|RBV|200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16112297|NCT02071459|Drug|placebo|initial period (4 weeks) followed by 8 weeks
16111830|NCT02074709|Drug|Plain bupivacaine|"Intraoperative: TAP block with plain bupivacaine + Acetaminophen 1000 mg IV + Ketorolac 30 mg IV .
~First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine.
~24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h,prn"
16111831|NCT02074709|Drug|Liposomal bupivacaine|"Group intraoperative: Wound infiltration with liposomal bupivacaine (Exparel) + IV acetaminophen 1000 mg IV + Ketorolac 30 mg IV
~First 24-h Postoperative: Ketorolac 30 mg, IV 3 more doses, + acetaminophen 1000 mg 3 more doses, + IV-PCA morphine
~24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn"
16111832|NCT02074683|Procedure|Year A Pathway|Fat Grafting Operative Procedure followed by Standard of Care Follow-up.
16111833|NCT02074683|Procedure|Year B Pathway|Standard of Care Followed by Fat Grafting Operative Procedure
16111834|NCT02074670|Other|Treadmill gait training|Five days a week, 40 sessions of Kinesiotherapy (passive and active mobilizations, muscle lengthening), Body Weight Supported Treadmill Training, bicycle, manual therapy (with and without assistance of a mechanical device) and daily life activities training.
16111835|NCT02074657|Biological|Activated and expanded natural killer cells (NKAEs)|Activated and expanded natural killer cells (NKAEs) from haploidentical donor
16111836|NCT02074644|Procedure|Prostatic Arterial Embolization|"The prostatic arteries are selectively catheterized with a Progreat 2.7 microcatheter and an angiography is performed to confirm that the catheter is in the prostatic artery. Bead Block 300-500 or PVA 100+200 micra particles are slowly injected under fluoroscopic control until the end point is reached. Embolization is considered finished when there is near stasis in the prostatic vessels with interruption of the arterial flow and prostatic gland opacification checked in both oblique and AP views. Upon finishing the embolization of the left prostatic arteries, the right prostatic arteries are embolized in the same way."
16111837|NCT02074644|Procedure|Sham procedure|The prostatic arteries are selectively catheterized with a Progreat 2.7 microcatheter and an angiography is performed to confirm that the catheter is in the prostatic artery. The catheter is removed and no particles are injected.
16111838|NCT02074631|Drug|Pamidronate|Subjects randomized to pamidronate treatment will receive infusions, 1 mg/kg (to a max dose of 60mg) over 4 hours, every 3 months at approximately 100 days, 180 days, and 270 days after HCT.
16111839|NCT02074631|Drug|Calcium and vitamin D|All subjects will receive a standard recommended dose of 600 IU/day of vitamin D. Subjects who do not meet the RDA will receive additional calcium supplementation.
16111840|NCT02074618|Other|Physical exercise.|Physical exercises were held three times a week on alternate days to hemodialysis sessions, with duration of 45 to 90 minute, supervised by a physiotherapist. In all the sessions the following measurements were performed: body weight and blood pressure, heart rate and peripheral oxygen saturation in the pre, during and post session. The exercises were: heating and stretching during 5 minutes, followed by aerobic physical exercise on treadmill and/or bike (about 30 minutes), muscle strengthening exercises (15 to 20 minutes), cooling and stretching (5 minutes). The time for aerobic and strengthening varied according to the tolerance of the patient. The resistance exercises have been conducted for the major muscle groups of the lower limbs.
16111841|NCT02074605|Biological|Interferon alpha|
16111842|NCT02074592|Behavioral|Self assessment of ultrasound fetal biometry images|self assessment of ultrasound fetal biometry images followed by automatically generated feedback
16111843|NCT02074592|Behavioral|assessment of ultrasound fetal biometry images by expert|assessment of ultrasound fetal biometry images by expert, followed by automatically generated feedback
16111844|NCT02074579|Drug|TU-100|15g daily, orally as 5g three times daily for 4 consecutive weeks
16111845|NCT02074579|Drug|Placebo|Matching placebo given 5g three times daily orally for 4 consecutive weeks
16111846|NCT02074566|Other|Cryoballoon ablation|PVI using cryoballoon
16111847|NCT02074553|Drug|Part 1 (Fasted): Treatment A|Participants following an overnight fast of at least 10 hours will receive 600 mg of alectinib orally as Treatment A (capsule formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 1.
16111848|NCT02074553|Drug|Part 1 (Fasted): Treatment B|Participants following an overnight fast of at least 10 hours will receive 600 mg of alectinib orally as Treatment B (capsule formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 1.
16111849|NCT02074553|Drug|Part 1 (Fasted): Treatment C|Participants following an overnight fast of at least 10 hours will receive 600 mg of alectinib orally as Treatment C (capsule formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 1.
16111850|NCT02074553|Drug|Part 1 (Fasted): Treatment D|Participants following an overnight fast of at least 10 hours will receive 600 mg of alectinib orally as Treatment D (capsule formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 1.
16111851|NCT02074553|Drug|Part 2 (Fed): Treatment A|Participants following an overnight fast of at least 10 hours will eat a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal will receive 600 mg of alectinib orally as Treatment A (capsule formulation containing 50% SLS) on Day 1 of any of the four intervention periods in Part 2.
16111852|NCT02074553|Drug|Part 2 (Fed): Treatment B|Participants following an overnight fast of at least 10 hours will eat a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal will receive 600 mg of alectinib orally as Treatment B (capsule formulation containing 25% SLS) on Day 1 of any of the four intervention periods in Part 2.
16111853|NCT02074553|Drug|Part 2 (Fed): Treatment C|Participants following an overnight fast of at least 10 hours will eat a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal will receive 600 mg of alectinib orally as Treatment C (capsule formulation containing 12.5% SLS) on Day 1 of any of the four intervention periods in Part 2.
16111854|NCT02074553|Drug|Part 2 (Fed): Treatment D|Participants following an overnight fast of at least 10 hours will eat a high-fat, high-calorie meal in 30 minutes or less and 30 minutes after the start of the meal will receive 600 mg of alectinib orally as Treatment D (capsule formulation containing 3% SLS) on Day 1 of any of the four intervention periods in Part 2.
16111855|NCT02074540|Other|Questionnaire|Questionnaire that is based on socio-demographic characteristics, Morisky's Four-Item Self-Reported Adherence Measure, Becker's Theory of Health Beliefs and Mishel's Theory of Uncertainty
16111856|NCT02074514|Drug|Sofosbuvir|400 mg tablet administered orally once daily
16111968|NCT02073838|Drug|Vismodegib|
16111858|NCT02074501|Other|training capacity in caregivers|"The participants of the InCARE programme (intervention group) will receive, additionally, intervention based on: (i) empowering caregivers to put hands on caring, which will be the key-point of the pilot programme; (ii) training handling techniques: mobility, bathing, (un)dressing, transferring, positioning, eating and drinking using technical aids, after 1 week, 1 month and 3 months, post hospital discharge."
16111859|NCT02074488|Other|Balancing Act exercise curriculum|"Balance improvement exercise curriculum titled Balancing Act"
16111860|NCT02074488|Other|Informational Brochure|Informational Brochure on falls prevention
16111861|NCT02074475|Other|Control group|A group of no Monitoring patients from larger AoA study with no adequacy of anaesthesia monitoring
16111862|NCT02074436|Drug|EACA|EACA 1000 mg twice a day. Patients will receive platelet transfusion in case of grade ≥ 2 bleeding.
16111863|NCT02074436|Other|Platelet transfusion|Prophylactic platelet transfusion. Additional platelet transfusions will be administered in case of grade ≥ 2 bleeding.
16111864|NCT02074423|Dietary Supplement|MealShape cinnamon extract|Acute administration of 1 g PO (2 capsules of 500 mg)
16111865|NCT02074423|Dietary Supplement|Placebo|Acute administration of 1 g PO (2 capsules of 500 mg)
16111866|NCT02074410|Drug|OMS643762|
16111867|NCT02074410|Drug|Placebo|
16111868|NCT02074397|Procedure|Distant extrafascial injection|
16111869|NCT02074397|Procedure|Subfascial injection|
16111870|NCT02074384|Device|Continuous Glucose Monitor|CGM device for measurement of interstitial glucose on a 24/7 continuous cycle.
16111871|NCT02074384|Device|Self Monitoring Blood Glucose|Participants will use their own SMBG device.
16111872|NCT02074384|Other|Clinician|Survey of clinicians after study visits
16111873|NCT02074358|Drug|Apixaban|
16111874|NCT02074358|Drug|Cofact (4-Factor PCC)|
16111875|NCT02074358|Drug|Beriplex P/N (4-Factor PCC)|
16111876|NCT02074358|Drug|Placebo (Saline solution)|
16111877|NCT02074345|Biological|TAK-816|TAK-816 intramuscular injection
16111878|NCT02074332|Behavioral|Physical activity guidance|Physical education class amelioration Additional physical activities for overweight&obese students Family physical activities Parent involvement
16111879|NCT02074332|Behavioral|Health education|Knowledge of obesity prevention and control
16111880|NCT02074319|Drug|Methotrexate|Treatment as usual or standard treatment for psychosis will be common in all arms
16111881|NCT02074306|Device|UROSHIELD®|An active UROSHIELD® device (low energy acustic wave generator) will be connected to an intratracheal tube externally. The device will transform low energy ultrasound waves on to the tube. These waves will by assumption lower the formation of bacterial growth and resistance to antibiotics.
16111882|NCT02074306|Device|SHAM UROSHIELD®|SHAM UROSHIELD® will be connected to endotracheal tubes unable to transform any waves.
16111883|NCT02074293|Drug|Gadolinium|Gadolinium .1cc/ diluted with .9ccNS intramuscularly with ASIS Device for 30 patients. Total cumulative Persistent % of Gadolinium intramuscularly on MRI at 6 hrs, 12 hrs, and 24 hrs.
16111884|NCT02074293|Drug|Gadolinium|Gadolinium .1cc/ diluted with .9ccNS subdermally with ASIS Device for 30 patients. Total cumulative Persistent % of Gadolinium subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs.
16111885|NCT02074293|Drug|Gadolinium|Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.
16111886|NCT02074293|Drug|Efficacy of Botox intramuscularly at Week 6|Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 6, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).
16111887|NCT02074293|Drug|Efficacy of Botox intramuscularly at Week 12|Efficacy of Botox intramuscularly at Week 12, in terms of Percent of Patients with Improved PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, Change from Baseline in Pain Intensity, Change from Baseline in CDSS (Cervical Dystonia Severity Scale).
16111888|NCT02074293|Drug|Efficacy of Botox intramuscularly at Week 18|Efficacy of Botox intramuscularly at Week 18, in terms of Percent of Patients with Improved PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, Change from Baseline in Pain Intensity, Change from Baseline in CDSS (Cervical Dystonia Severity Scale).
16111889|NCT02074293|Drug|Efficacy of Botox intramuscularly at Week 24|Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 24, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).
16111890|NCT02074293|Drug|Efficacy of Botox intramuscularly at Week 30|Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).
16111891|NCT02074293|Drug|Efficacy of Botox subdermally at Week 6|Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 6, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).
16111892|NCT02074293|Drug|Efficacy of Botox subdermally at Week 12|Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 12, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).
16111893|NCT02074293|Drug|Efficacy of Botox subdermally at Week 18|Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 18, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).
16111894|NCT02074293|Drug|Efficacy of Botox subdermally at Week 24|Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 24, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).
16111895|NCT02074293|Drug|Efficacy of Botox subdermally at Week 30|Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 30, in terms of improvement on the Physician Global Assessment Scale, and Change from Baseline in Pain Frequency, and Pain Intensity, as well as Cervical Dystonia Severity Scale (CDSS).
16111969|NCT02073838|Drug|Decitabine|
16111970|NCT02073825|Behavioral|Web Brief Intervention (WBI)|4-session WBI
16111896|NCT02074293|Drug|Adverse Reactions of Botox intramuscularly|Adverse Reactions of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
16111897|NCT02074293|Drug|Adverse Reactions of Botox subdermally|Adverse Reactions of Botox (onabotulinumtoxinA) subdermally at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
16111898|NCT02074280|Drug|rifaximin|Rifaximin is an antibiotic that is virtually non-absorbed after oral administration and exhibits broad spectrum antimicrobial activity against both aerobic and anaerobic gram-positive and gram-negative microorganisms within the gastrointestinal tract.
16111899|NCT02074267|Drug|Carbatin|"Carbatin® or Neurontin® is initiated at 100 mg at night and slowly titrated to 300~800 mg three times/day over 4 to 25 days.
~The dose of Carbatin® or Neurontin® taken by each patient will amount to 100 to 2400 mg /day oral if the pain intensity reaches a VAS score ≧4. The maintenance dose of Carbatin® or Neurontin® will throughout for at least 14 days of the treatment period."
16111900|NCT02074267|Drug|Neurontin|"Carbatin® or Neurontin® is initiated at 100 mg at night and slowly titrated to 300~800 mg three times/day over 4 to 25 days.
~The dose of Carbatin® or Neurontin® taken by each patient will amount to 100 to 2400 mg /day oral if the pain intensity reaches a VAS score ≧4. The maintenance dose of Carbatin® or Neurontin® will throughout for at least 14 days of the treatment period."
16111901|NCT02074241|Other|Expression analysis|Analysis of the expression of DNA repair genes (XPC, XPF, Brca1, Rad51,SNF5, etc.) in bladder cancer specimens.
16111902|NCT02074228|Drug|Methylphenidate (Concerta)|
16111903|NCT02074215|Other|Aerobic exercises|Aerobic exercises + dual task
16111904|NCT02074215|Other|Stretch exercise|Stretch exercise
16111905|NCT02074202|Drug|18F- fluorocholine|To compare the diagnostic efficacy of FCH PET scan to FDG PET scan.
16111906|NCT02074202|Drug|18F- fluorodeoxyglucose|To compare the diagnostic efficacy of FCH PET scan to FDG PET scan
16111907|NCT02074189|Drug|Gemcitabine, Cisplatin|Gemcitabine 1000 mg/m2 iv,D1,D8,D15;cisplatin 70 mg/m2 iv,D2.With 4 cycles. Treatment begins between 1-5 weeks after radical operation (within 42 days is recommended)
16111908|NCT02074163|Drug|Gadolinium|Gadolinium .1cc/ diluted with .9ccNS intramuscularly with ASIS Device for 30 patients. Total cumulative Persistent % of Gadolinium intramuscularly on MRI at 6 hrs, 12 hrs, and 24 hrs.
16111909|NCT02074163|Drug|Gadolinium|Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.
16111910|NCT02074163|Drug|Efficacy of Botox intramuscularly at Week 6|Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 6, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
16111911|NCT02074163|Drug|Efficacy of Botox intramuscularly at Week 12|Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 12, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
16111912|NCT02074163|Drug|Efficacy of Botox intramuscularly at Week 18|Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 18, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
16111913|NCT02074163|Drug|Efficacy of Botox intramuscularly at Week 24,|Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 24, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
16111914|NCT02074163|Drug|Efficacy of Botox intramuscularly at Week 30|Efficacy of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
16111915|NCT02074163|Drug|Efficacy of Botox subdermally at Week 6|Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 6, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
16111916|NCT02074163|Drug|Efficacy of Botox subdermally at Week 12|Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 12, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
16111917|NCT02074163|Drug|Efficacy of Botox subdermally at Week 18|Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 18, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
16111918|NCT02074163|Drug|Efficacy of Botox subdermally at Week 24|Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 24, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
16111919|NCT02074163|Drug|Efficacy of Botox subdermally at Week 30|Efficacy of Botox (onabotulinumtoxinA) subdermally at Week 30, in terms of Change in frequency of headache days, and Change in hrs of HA on HA days.
16111920|NCT02074163|Drug|Adverse Reactions of Botox intramuscularly|Adverse Reactions of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
16111921|NCT02074163|Drug|Adverse Reactions of Botox subdermally|Adverse Reactions of Botox (onabotulinumtoxinA) subdermally at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
16111922|NCT02074150|Drug|Gadolinium|"Gadolinium .1cc/ diluted with .9ccNS intramuscularly with ASIS Device for 30 patients.
~Total cumulative Persistent % of Gadolinium intramuscularly on MRI at 6 hrs, 12 hrs, and 24 hrs."
16111923|NCT02074150|Drug|Gadolinium|"Gadolinium .1cc/ diluted with .9ccNS subdermally with ASIS Device for 30 patients.
~Total cumulative Persistent % of Gadolinium subdermally on MRI at 6 hrs, 12 hrs, and 24 hrs."
16111924|NCT02074150|Drug|Gadolinium|Relative Prolongation Ability Score or total Persistent % of Gadolinium subdermally over total Persistent % of Gadolinium intramuscularly on MRI.
16111925|NCT02074150|Drug|Efficacy of Botox intramuscularly at Week 6|Efficacy of Botox intramuscularly at Week 6, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
16111971|NCT02073812|Drug|RPX7009 and RPX2014|The study is designed to enroll approximately 25 healthy subjects. The study will evaluate the plasma, epithelial lining fluid, and alveolar macrophage concentrations of Carbavance (RPX7009/RPX2014)
16112298|NCT02071433|Procedure|Saphenous nerve blockade|
16111926|NCT02074150|Drug|Efficacy of Botox intramuscularly at Week 12,|Efficacy of Botox intramuscularly at Week 12, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
16111927|NCT02074150|Drug|Efficacy of Botox intramuscularly at Week 18|Efficacy of Botox intramuscularly at Week 18, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
16111928|NCT02074150|Drug|Efficacy of Botox intramuscularly at Week 24|Efficacy of Botox intramuscularly at Week 24, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
16111929|NCT02074150|Drug|Efficacy of Botox intramuscularly at Week 30|Efficacy of Botox intramuscularly at Week 30, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
16111930|NCT02074150|Drug|Efficacy of Botox subdermally at Week 6|Efficacy of Botox subdermally at Week 6, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
16111931|NCT02074150|Drug|Efficacy of Botox subdermally at Week 12|Efficacy of Botox subdermally at Week 12, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
16111932|NCT02074150|Drug|Efficacy of Botox subdermally at Week 18|Efficacy of Botox subdermally at Week 18, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
16111933|NCT02074150|Drug|Efficacy of Botox subdermally at Week 24|Efficacy of Botox subdermally at Week 24, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
16111934|NCT02074150|Drug|Efficacy of Botox subdermally at Week 30|Efficacy of Botox subdermally at Week 30, in terms of Change from Baseline in PGAS, or improvement on the Physician Global Assessment Scale, and Change from Baseline in Elbow Ashworth, Change from Baseline in Wrist Ashworth, Change from Baseline in Finger Ashworth, and Change from Baseline in Thumb Ashworth.
16111935|NCT02074150|Drug|Adverse Reactions of Botox intramuscularly|Adverse Reactions of Botox (onabotulinumtoxinA) intramuscularly at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
16111936|NCT02074150|Drug|Adverse Reactions of Botox subdermally|Adverse Reactions of Botox (onabotulinumtoxinA) subdermally at Week 30, in number of Headache Migraine, Facial paresis, Eyelid ptosis, Bronchitis, Neck pain Musculoskeletal stiffness, Muscular weakness Myalgia, Musculoskeletal pain, Muscle spasms, Injection site pain, and Hypertension.
16111937|NCT02074137|Drug|CABAZITAXEL XRP6258|Pharmaceutical form:Solution Route of administration: Intravenous
16111938|NCT02074137|Drug|Prednisone|Pharmaceutical form:Tablet Route of administration: Oral
16111939|NCT02074137|Drug|Prednisolone|Pharmaceutical form:Tablet Route of administration: Oral
16111940|NCT02074098|Device|Macintosh laryngoscope|Direct Laryngoscope
16111941|NCT02074098|Device|Glidescope|Videolaryngoscope-1
16111942|NCT02074098|Device|Airwayscope|Videolaryngoscope-2
16111943|NCT02074072|Device|15 degree left-lateral tilt wedges|The wedges are made of aluminium
16111944|NCT02074072|Device|30 degree left-lateral tilt wedges|The wedges are made of aluminium
16111945|NCT02074059|Drug|Lucinactant for Inhalation|Lucinactant for Inhalation refers to the active investigational agent, lucinactant, in combination with the investigational delivery device (drug-device combination product)
16111946|NCT02074059|Device|nCPAP alone|nCPAP therapy
16111947|NCT02074046|Biological|cancer stem cell vaccine|
16111948|NCT02074020|Drug|Blisibimod|Administered via subcutaneous injection once per week
16111949|NCT02074020|Drug|Placebo|Administered via subcutaneous injection once per week
16111950|NCT02074007|Drug|AR01|drops administered as needed for pain
16111951|NCT02074007|Drug|Placebo Comparator|Glycerin ear drops (placebo) drops administered as needed for ear pain
16111952|NCT02073994|Drug|AG-120|AG-120 administered continuously as a single agent dosed orally on Days 1 to 28 of a 28-day cycle. Subjects may continue treatment with AG-120 until disease progression or development of other unacceptable toxicity
16111953|NCT02073968|Drug|Carboplatin|Given IV
16111954|NCT02073968|Procedure|Computed Tomography|Undergo PET-adjusted IMRT
16111955|NCT02073968|Radiation|Intensity-Modulated Radiation Therapy|Undergo PET-adjusted IMRT
16111956|NCT02073968|Drug|Paclitaxel|Given IV
16111957|NCT02073968|Procedure|Positron Emission Tomography|Undergo PET-adjusted IMRT
16111958|NCT02073968|Radiation|Proton Beam Radiation Therapy|Undergo proton beam radiation therapy
16111959|NCT02073929|Drug|Liraglutide for 26 weeks|GLP-1-analogue Liraglutide s.c. 1,8mg daily for 26 weeks
16111960|NCT02073929|Drug|placebo|Placebo s.c. daily for 26 weeks
16111961|NCT02073916|Drug|T-DM1|antibody-drug conjugate of trastuzumab and emtansine
16111962|NCT02073916|Drug|Lapatinib|Dual tyrosine kinase inhibitor (HER2 and EGFR)
16111963|NCT02073916|Drug|Abraxane|albumin-bound paclitaxel. Chemotherapy - microtubule inhibitor
16111964|NCT02073903|Behavioral|Patient Survey|
16111965|NCT02073903|Behavioral|Provider Survey|
16111966|NCT02073851|Device|TriGuard™HDH|TriGuard™HDH Embolic Deflection Device in patients undergoing Transcatheter Aortic Valve Replacement (TAVR)
16111967|NCT02073838|Drug|Ribavirin|
16111972|NCT02073799|Procedure|Laser prostatectomy (Photoselective vaporization of the prostate or Holmium laser enucleation of the prostate)|
16111973|NCT02073786|Device|Conventional lightwand intubation|Conventional lightwand intubation technique will perform during intubation
16111974|NCT02073786|Device|Rigid video stylet|Rigid video stylet will inserted through endotracheal tube before induction. After induction with propofol and remifentanil using TIVA infusion pump, rocuronium 0.6mg/kg were used to facilitate intubation. After 2minutes, board-certificated anesthesiologist perform intubation using Optiscope.
16111975|NCT02073773|Drug|Levodopa|"Levodopa 100mg with benserazide 25mg will be administered 3 hours prior to the start of the daily PT/OT session to maximize its pharmacokinetic window ie. blood plasma levels in the narrow window during which functional rewiring of neural circuits is thought to occur.
~Levodopa at the lowest available dose (100mg P.O qd) has been shown to improve motor function of stroke patients and their corresponding quality of life. The treatment proposed can be incorporated into their daily rehabilitation routine. Early intervention (within 7-21 days of the infarct) raises the chance for neuroplasticity and improved recovery of their motor function in the short and long run. Levodopa has been proven to be safe to be used in stroke patients (Lancet. 2001 Sep 8;358(9284):787-90., Arch Phys Med Rehabil. 2008 Sep;89(9):1633-41.), however, the side effects of this medication may include nausea, unusual tiredness, dizziness, excessive watering of mouth."
16111976|NCT02073773|Other|Virtual Reality based therapy|The VR therapy session consists of the subject interacting with a computer-based program in which they guide an avatar to gather items by using flexion and extension gestures of the affected upper limb. VR therapy sessions will last for 15-30 minutes depending on the subject's tolerance and participation. For patients who are unable to overcome gravity fully, they can still participate in this therapy by resting their arm on a table.
16111977|NCT02073760|Other|There is no intervention. The investigators are interviewing cardiac surgery staff with knowledge of infection prevention.|The investigators will conduct tape recorded interviews with hospital staff about infection prevention.
16111978|NCT02073747|Drug|Normal Saline|One hour inhaled normal saline
16111979|NCT02073747|Drug|Albuterol|One hour inhaled ten milligrams of albuterol
16111980|NCT02073734|Drug|Dexamethasone|Dexamethasone 8mg/IV
16111981|NCT02073734|Drug|Placebo|Placebo given IV
16111982|NCT02073721|Other|electrostimulation with exercises MAPs|this group will make the electrostimulation with exercises of the pelvic floor muscles with a focus on strengthening the pelvic floor muscles.the frequency will be 20 sessions, 2 times per week, lasting 30 minutes.
16111983|NCT02073721|Other|exercises MAPs|This group will focus exercises of the pelvic floor muscles with strengthening the muscles of the pelvic floor. the frequency will be 20 sessions, 2 times per week, lasting 30 minutes.
16111984|NCT02073695|Procedure|Operative procedure to fix proximal humeral|Operative fixation by the shoulder team at Torbay Hospital
16111985|NCT02073695|Device|Neutral Rotation Brace|Performed at the end of the surgical procedure at Torbay Hospital
16111986|NCT02073695|Other|Physiotherapy review|Physiotherapy review on day of surgery, and post-surgery at 6 weeks, 3 months and 1 year.
16111987|NCT02073695|Other|Functional outcome forms filled in|
16111988|NCT02073695|Other|Postal functional outcome scores|Sent to patient at 9 weeks post surgery
16111989|NCT02073695|Other|Post-operative Radiographs|Performed at 6 weeks and 3 months at shoulder clinic appointment at Torbay Hospital
16111990|NCT02073682|Drug|Edoxaban|After the 5 day treatment with LMWH, patients receive edoxaban 60 mg once daily (QD) as 2 × 30 mg tablets (or 1 x 30 mg tablet QD for patients requiring dose adjustment) for the remainder of the treatment period.
16111991|NCT02073682|Drug|Dalteparin|Dalteparin was administered via subcutaneous injection at a dose of 200 IU/kg (maximum daily dose 18,000 IU) for 30 days, and at a dose of 150 IU/kg from Day 31 to the end of treatment.
16111992|NCT02073682|Drug|Low molecular weight heparin|Therapeutic doses of subcutaneous LMWH were administered for at least 5 days (to patients in the edoxaban group); this 5-day period may have included the pre-randomization LMWH (if applicable). The choice of parenteral LMWH was up to the treating physician.
16111993|NCT02073669|Procedure|Answering the study Questionnaire and blood sampling for Interferon gamma release assay (IGRA)|
16111994|NCT02073656|Drug|LDV/SOF|90/400 mg FDC tablet administered orally once daily
16111995|NCT02073656|Drug|RBV|Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16111996|NCT02073630|Other|active cerebellar stimulation|
16111997|NCT02073630|Other|sham cerebellar stimulation|
16111998|NCT02073617|Radiation|Real-time 3-dimensional DynaCT|After coronary angiography is performed, a 6Fr pigtail catheter will be placed in the aorta and 40cc of 50% contrast media diluted normal saline will be delivered using standard automated injection during dynaCT cardiac image acquisition. Intravenous delivery of contrast as alternative.
16111999|NCT02073604|Other|Healthy volunteers|Morphological and functional brain MRI; transcranial magnetic stimulation
16112000|NCT02073604|Other|Congenital mirror movements|Morphological and functional brain MRI; transcranial magnetic stimulation
16112001|NCT02073591|Other|Ceradan Cream|
16112002|NCT02073591|Other|Ceradan Wash|
16112003|NCT02073578|Procedure|Peroral Endoscopic Myotomy (POEM)|Endoscopy myotomy for treatment of achalasia
16112004|NCT02073565|Device|OrbusNeich Combo stent™|The Combo Stent is composed of the OrbusNeich R stent™, with an abluminal coating of a bioabsorbable polymer matrix formulated with sirolimus for sustained release, and an anti-CD34 antibody cell capture coating on the luminal surface.
16112005|NCT02073565|Device|Everolimus Eluting Stent (EES)|Everolimus Eluting Stent (EES) (Xience V, Xience Prime, Xience Xpedition stents, Abbott Vascular/Abbott Vascular Japan). Xience Prime inherited the clinical result of Xience V and is a product that obtains efficiency essentially equal to Xience V.
16112077|NCT02073097|Drug|Pegfilgrastim|6 mg SC day 4 (every 21 days). Filgrastim 300 or 480 mcg IV/SC daily days 1-10 may be substituted if pegfilgrastim is not available. ONPROTM is also an acceptable method of administration.
16112078|NCT02073097|Drug|Acyclovir|PO (400mg)
16112079|NCT02073084|Drug|K-877 Low Dose|K-877 Low Dose
16112080|NCT02073084|Drug|Moxifloxacin|
16112081|NCT02073084|Other|Placebo|
16112082|NCT02073084|Drug|K-877 High Dose|K-877 High Dose
16112006|NCT02073552|Drug|Polyethylene glycol 4000|- Polyethylene glycol 4000: 16 envelopes (70 g of powder each). It includes electrolytes and sodium sulfate. These substances make PEG metabolically inert, achieving a suitable osmotic balance, despite having a high molecular weight. The preparation passes along the gastrointestinal tract without causing net absorption of fluid or electrolytes. It is routinely used in clinical practice for bowel cleansing, before abdominal surgery, barium enema and other colorectal and genitourinary tract tests. Participants will divide the whole doses in 4 liters of water taking half the day before the examination starting at 20.00 h and the other half at 6.00 pm on the day of the examination.
16112007|NCT02073552|Drug|Macrogol 3350 plus ascorbic acid|- Macrogol 3350 plus ascorbic acid: 4 envelopes, 2 containing 112 g polyethylene glycol and electrolytes and 2 with 2 g of ascorbic acid. The properties of the polyethylene glycol are the same as those mentioned previously, while ascorbic acid generates an osmotic gradient potentiating the effect of polyethylene glycol. It is used routinely as a bowel prep. Participants will divide the doses in 2 liters of water taking half the day before (112 g of PEG and an 11 g of ascorbic acid) the examination at 20.00 h and the other half at 6.00 pm on the day of the examination
16112008|NCT02073539|Device|Stryker ST104-747|760 x 2110 mm, 228 kg, Stryker Co., Kalamazoo, Michigan, US
16112009|NCT02073539|Device|Shinchang SB-34p|, 850 x 2080 mm,Shinchang Co.,Busan,ROK
16112010|NCT02073526|Drug|Infliximab, adalimumab, certolizumab pegol|Patients are treated with the above mentioned drugs decided by clinicians
16112011|NCT02073513|Device|Kinesiotape plus thenar pressure (PPTG)|"In the kinesiotape plus thenar pressure (PPTG). Kinesiotape was applied to control the cortical thumb sign. In addition a piece of plastazote aiming to give thenar pressure was also applied.
~The amount of pressure was regulated so that the child felt the pressure without being irritated and without restriction in grasping functions."
16112012|NCT02073513|Device|Taping Group (TG)|In the taping group (TG) kinesiotape was applied to control the cortical thumb sign.
16112013|NCT02073500|Other|Observational study.|"Analysis of metastatic tissue and blood specimens collected from patients with PSM undergoing CRS-HIPEC. CRS: Removal of all macroscopically detectable tumor.
~HIPEC: Instillation of heated chemotherapy in the abdominal cavity to remove residual cancer disease."
16112014|NCT02073487|Drug|T-DM1|antibody-drug conjugate of trastuzumab and emtansine
16112015|NCT02073487|Drug|Trastuzumab|anti-Her2 monoclonal antibody
16112016|NCT02073487|Drug|Lapatinib|Dual tyrosine kinase inhibitor (HER2 and EGFR)
16112017|NCT02073487|Drug|Abraxane|albumin-bound paclitaxel. chemotherapy - microtubule inhibitor.
16112018|NCT02073487|Drug|Paclitaxel|chemotherapy - microtubule inhibitor
16112019|NCT02073487|Drug|Pertuzumab|anti-HER2 monoclonal antibody
16112020|NCT02073474|Drug|Sativex®|Contains delta-9-tetrahydrocannabinol (THC), 27 mg/mL; cannabidiol (CBD), 25 mg/mL; in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Each actuation delivers THC 2.7 mg and CBD 2.5 mg.
16112021|NCT02073461|Drug|CD1579 2.5%|
16112022|NCT02073461|Drug|CD1579 5%|
16112023|NCT02073461|Drug|Vehicle|
16112024|NCT02073448|Drug|GK530G|
16112025|NCT02073448|Drug|CD0271|
16112026|NCT02073448|Drug|CD1579|
16112027|NCT02073435|Behavioral|Donor pain management|"The evidence-based donor pain management solution entails the following elements:
~Preoperative Assessment and Management:
~Assessment of Patient Risk factors for Respiratory Depression (e.g. OSA Assessment: STOP BANG Questionnaire)
~Bowel preparation (e.g. Colace or Golytely)
~Patient Postoperative Pain Education - Educational handout on postoperative pain
~At the end of the case in OR:
~Local Anesthetic (TAP block, OnQ device, intrathecal, local infiltration)
~I.V. Ketorolac (when adequate hemostasis is determined by surgeon and urine output is > 500cc)
~I.V. Steroids (Dexamethasone or Solumedrol)
~Postoperative Management:
~NSAIDS x 72 hours followed by po cox-inhibitor until discharge (e.g. Celecoxib)
~Opioids (Dilaudid PCA followed by oral opioids (e.g., Tylenol #3))
~Postoperative Assessment:
~o CO2 monitoring in PACU/ICU for early monitoring of respiratory depression"
16112028|NCT02073422|Device|Fractional flow reserve|Guidewire-based index of coronary artery stenosis severity measured when coronary microvascular resistance is minimised by administration of a vasodilator drug.
16112029|NCT02073422|Other|Magnetic resonance imaging|Cardiac magnetic resonance imaging at 3.0 Tesla, including perfusion MRI at rest and during pharmacological stress with intravenous adenosine (140-210 ug/kg/min).
16112030|NCT02073396|Diagnostic Test|Blood test|Patients will undergo the tests of thrombosis, before and after stabilisation of their cardiac condition. Cardiac stabilisation will be provided by clinical cardiac teams, outside and independently from the study.
16112031|NCT02073383|Procedure|Axillary brachial plexus block|
16112032|NCT02073357|Procedure|Light general anaesthesia (BIS = 50)|
16112033|NCT02073357|Procedure|deep general anaesthesia (BIS = 35)|
16112034|NCT02073344|Procedure|Renal replacement therapy|intermittent hemodialysis or peritoneal dialysis
16112035|NCT02073344|Other|no intervention|no renal replacement therapy
16112036|NCT02073318|Other|Task-oriented balance training|4 weeks individualized task-oriented balance training, twice a week and 1 hour each session
16112037|NCT02073318|Other|Upper extremities exercise|"4 weeks upper extremities exercise in sitting position, twice a week and 1 hour each session
~weeks"
16112038|NCT02073305|Other|No Sleep Apnea|No intervention
16112039|NCT02073305|Other|Sleep Apnea - untreated|No intervention
16112040|NCT02073305|Device|Sleep Apnea - treated|Sleep Apnea treatment by positive pression ventilation (CPAP/BIPAP) or sleep apnea oral appliance
16112041|NCT02073292|Procedure|c-RFA|
16112042|NCT02073292|Procedure|tRFA|
16112043|NCT02073279|Drug|Satralizumab|Satralizumab will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).
16112044|NCT02073279|Drug|Placebo|Placebo will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).
16112045|NCT02073266|Procedure|Macular hole surgery using a 25 G pars plana vitrectomy, ILM peeling, fluid-air exchange followed by air-gas exchange with SF6 or C3F8.|
16112083|NCT02073071|Other|Preterm infant formula per standard of care|Commercially available preterm infant formula
16112084|NCT02073058|Device|No treatment|
16112085|NCT02073045|Other|educational intervention|Receive educational handouts
16112086|NCT02073045|Other|lymphedema survey|Ancillary studies
16112046|NCT02073253|Other|Noninvasive ventilation|In the experimental phase with NIV ventilatory support with bilevel positive pressure was used for 30 minutes with the subject comfortably seated. The NIV (Vivo 40 Bi-Level, General Electric Company) was fitted to the face of volunteer through a face mask, was initially adopted an inspiratory pressure (IPAP) of 15 cm H2O and an expiratory pressure (PEEP) of 5 cmH2O, resulting in a variation in pressure of 10 cm H2O, where the IPAP would be increased, subject to the comfort of the patient until the patient reached a tidal volume of 6-8 ml / kg, not exceeding the maximum of 20 cmH2O for IPAP.
16112047|NCT02073240|Behavioral|Enhanced TB IC Package|"Facilities randomized to the intervention group will receive:
~Skills-based training addressing the hierarchy of TB IC measures, how to conduct a facility TB IC /risk assessment; and development, implementation, and monitoring of an operational TB IC plan for the facility
~Audits and Feedback of performance
~A TB IC collaborative membership
~A standardized unit-level daily checklist of critical IC activities"
16112048|NCT02073227|Drug|Canagliflozin, 300 mg|Each tablet contains canagliflozin (CANA) of 300 mg to be taken orally (by mouth).
16112049|NCT02073227|Drug|Metformin XR, 500 mg|Each tablet contains metformin extended release (MET XR), 500 mg, to be taken orally (by mouth).
16112050|NCT02073227|Drug|CANA/MET XR FDC, Formulation 1, 150 mg/1,000 mg|Each tablet contains 150 mg of canagliflozin and 1,000 mg of metformin HCl granulate formulation 1, in release-controlling polymers to obtain the XR granulation, to be taken orally.
16112051|NCT02073227|Drug|CANA/MET XR FDC, Formulation 2, 150 mg/1,000 mg|Each tablet contains 150 mg of canagliflozin and 1,000 mg of metformin HCl granulate formulation 2, in release-controlling polymers to obtain the XR granulation, to be taken orally.
16112052|NCT02073214|Other|Probiotic|Standard treatment plus probiotic
16112053|NCT02073214|Other|Placebo|Standard treatment plus placebo
16112054|NCT02073201|Other|High-functioning older adults|Participants with a SPPB score ≥ 11 will be categorized as high-functioning. The following test will be performed: Health and Quality of Life questionnaires, Mobility Assessments, Accelerometry, Body Composition (DEXA scan), Strength assessments, Neuromuscular stimulation, and Magnetic resonance imaging (MRI).
16112055|NCT02073201|Other|Lower-functioning older adults|Participants with a SPPB score ≤ 8 will be categorized as lower-functioning. The following test will be performed: Health and Quality of Life questionnaires, Mobility Assessments, Accelerometry, Body Composition (DEXA scan), Strength assessments, Neuromuscular stimulation, and Magnetic resonance imaging (MRI).
16112056|NCT02073201|Other|Young adults|Participants between the 20 - 30 years of age. The following test will be performed: Health and Quality of Life questionnaires, Mobility Assessments, Accelerometry, Body Composition (DEXA scan), Strength assessments, Neuromuscular stimulation, and Magnetic resonance imaging (MRI).
16112057|NCT02073188|Device|iBGStar|
16112058|NCT02073188|Device|Traditional Glucometer|
16112059|NCT02073175|Drug|Motherwell|The interventions involves a dietary supplement called Motherwell, at current stage, to reduce the intensity of sadness in women vulnerable to sadness.
16112060|NCT02073162|Procedure|Major Abdominal Surgery|•All types of open or lap-assisted abdominal or pelvic surgery with an expected duration of at least 2 hours, and an expected hospital stay of at least 3 days (for example, oesophagectomy, gastrectomy, pancreatectomy, colectomy, aortic or aorto-femoral vascular surgery, nephrectomy, cystectomy, open prostatectomy, radical hysterectomy, and abdominal incisional hernia repair)
16112061|NCT02073149|Dietary Supplement|Low-dose iron as NaFeEDTA|Daily home fortification for 30 days with 3 mg iron as NaFeEDTA, vitamin A (300 RE μg as retinyl palmitate) and 5 mg zinc (as gluconate)
16112062|NCT02073149|Dietary Supplement|Conventional dose iron as ferrous salt|Daily home fortification for 30 days with 12.5 mg iron as encapsulated ferrous fumarate, vitamin A (300 RE μg as retinyl palmitate) and 5 mg zinc (as gluconate)
16112063|NCT02073149|Dietary Supplement|Placebo|Daily home fortification for 30 days with vitamin A (300 RE μg as retinyl palmitate) and 5 mg zinc (as gluconate)
16112064|NCT02073136|Other|Diet with phosphate containing additives|
16112065|NCT02073136|Other|Diet without phosphate containing additives|
16112066|NCT02073123|Drug|Indoximod|"Initial dose of 600mg BID by mouth with escalation planned to 1200mg BID by mouth
~Dose escalation:
~If 0 of the 3 subjects forming the first cohort experience RLT, 1200mg BID cohort will be enrolled
~If 1 of the 3 subjects in any cohort experiences a RLT, then enrollment into that cohort will increase to a total of 6 subjects
~If > 1 of the 3-6 subjects experience a RLT, then the MTD has been exceeded and further enrollment into the cohort will cease
~If >1 subject at 600mg BID experiences a RLT, the dose will be de-escalated to 400mg BID. If >1 subject at this level experiences a RLT, one additional de-escalation to 200mg BID is allowed
~Dosing cycles are 21 days in length during the combination immunotherapy component (first 4 cycles) and 28 days during indoximod monotherapy. Patients will continue until they experience disease progression or limiting toxicity
~Phase 2 Treatment Plan (Cohort 2) Will receive fixed dose of indoximod determined in phase 1"
16112067|NCT02073123|Drug|Ipilimumab|Ipilimumab administered intravenously at 3 mg/kg every three weeks for a total of four doses.
16112068|NCT02073123|Drug|Nivolumab|Nivolumab administered intravenously at 240 mg every 2 weeks.
16112069|NCT02073123|Drug|Pembrolizumab|Pembrolizumab administered intravenously at 2 mg/kg every three weeks.
16112070|NCT02073110|Device|Percutaneous Optical Biopsy (OCT and DRS)|
16112071|NCT02073097|Drug|Carfilzomib|"Given IV, according to dose level. Cohorts begin with dose level (DL)1, escalated in standard 3+3 design to identify a recommended phase 2 dose DL (-2) 11 mg/m2 on day 1 and 2 every 21 days, cycles 1-6
~DL (-1) 15 mg/m2 on days 1 and 2 every 21 days, cycles 1-6
~DL (1) 20 mg/m2 days 1,2 every 21 days, cycles 1-6
~DL (2) 20 mg/m2 days 1,2 of cycle 1 followed by 27 mg/m2 days 1,2 every 21 days for cycles 2-6.
~DL (3) 20 mg/m2 days 1,2 of cycle 1 followed by 36 mg/m2 days 1,2 every 21 days for cycles 2-6.
~DL(4) 20 mg/m2 days 1,2 of cycle 1 followed by 45 mg/m2 days 1,2 every 21 days for cycles 2-6
~DL (5) 20 mg/m2 days 1,2 of cycle 1 followed by 56 mg/m2 days 1,2 every 21 days for cycles 2-6"
16112072|NCT02073097|Biological|Rituximab|Given IV (375mg/m^2)
16112073|NCT02073097|Drug|Cyclophosphamide|Given IV (750mg/m^2)
16112074|NCT02073097|Drug|Doxorubicin hydrochloride|Given IV (50mg/m^2)
16112075|NCT02073097|Drug|Vincristine sulfate|Given IV (1.4mg/m^2)
16112076|NCT02073097|Drug|Prednisone|Given PO (100mg)
16112087|NCT02073032|Other|No intervention, only observation|
16112088|NCT02073019|Drug|BL-8040|
16112089|NCT02073019|Drug|Placebo|
16112090|NCT02073006|Dietary Supplement|Natural Fibre Supplement|Natural Fibre Supplement 2 doses per day for 4 weeks
16112091|NCT02072993|Drug|AZD1979|Single dose, oral solution administration
16112092|NCT02072993|Drug|Placebo to match|Single dose, oral solution administration
16112093|NCT02072980|Device|Delefilcon A contact lenses|Silicone hydrogel contact lenses
16112094|NCT02072967|Other|Ribomustin|Routine practice
16112095|NCT02072967|Other|rituximab|Routine practice
16112096|NCT02072954|Drug|Asenapine Sublingual Tablets 10 mg|White to off-white, round, uncoated,unscored, flat-faced radius edge tablet. Debossed with A on one side and 17 on the other side
16112097|NCT02072954|Drug|Asenapine Sublingual Tablets 10 mg|"Round, white to off-white sublingual tablets, with 10 on one side within a circle"
16112098|NCT02072941|Behavioral|PREPARE Intervention|At week 1, 3, 6, and 12 months, interviews (telephone or in person based on preference) by blinded staff will assess engagement in advance care planning (ACP), self-efficacy with ACP, and activation in and satisfaction with decision making. Blinded telephone interviews will also assess surrogate reports of patient engagement in ACP.
16112099|NCT02072928|Biological|botulinum toxin Type A|botulinum toxin Type A (BOTOX®) prescribed as standard of care in clinical practice.
16112100|NCT02072915|Procedure|Suction|
16112101|NCT02072889|Other|Neck Angle|Ultrasound guided measures of the neck of subjects undergoing cardiac surgery who need internal jugular vein cannulated
16112102|NCT02072863|Drug|Oprozomib|Study subjects will receive oprozomib administered orally.
16112103|NCT02072863|Drug|Melphalan|Study subjects will receive melphalan 9 mg/m2.
16112104|NCT02072863|Drug|Prednisone|Study subjects will receive prednisone 60 mg/m2.
16112105|NCT02072850|Device|Coronary pressure wire|Guidewire-based coronary pressure- and temperature recordings (coronary thermodilution) with and without hyperaemia induced by intravenous administration of adenosine (140 ug/kg/min) in patients with acute ST-elevation myocardial infarction treated by emergency PCI.
16112106|NCT02072850|Other|Magnetic resonance imaging of the heart|Cardiac magnetic resonance imaging (MRI) with gadolinium contrast imaging at baseline (~ day 2) and 6 months (all participants) and in 30 subjects at 4 time-points (< 12 hours, days 2, 7-10 and at 6 months).
16112107|NCT02072824|Drug|Pregabalin Dose Level 1|Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 7.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase
16112108|NCT02072824|Drug|Pregabalin Dose Level 2|Pregabalin liquid dosed daily three times a day in equally divided doses escalated to 14.0 mg/kg/day beginning at Randomization through Taper Phase then tapered to 3.5 mg/kg/day during 1 week Taper Phase
16112109|NCT02072824|Drug|Placebo|Placebo Liquid dosed three times daily beginning at Randomization through Taper Phase
16112110|NCT02072811|Drug|DAC|"DNR 60 mg/m2 0,5h infusion iv on 1-3 days
~2-CdA 5 mg/m2 2h. infusion iv on 1-5 days
~Ara-C 200 mg/m2 12h infusion iv 2h after end of infusion with 2CdA on 1-7 days"
16112111|NCT02072811|Drug|CLAG|"G-CSF 30MU sc, on 0-5 days
~Mitoxantrone 10mg/m2 30 min infusion iv, on 1-3 days
~Cladribine 5mg/m2 in 2h infusion iv, on 1-5 days
~Ara-C 2000mg/m2 4h infusion iv, infusion start after 2h of Cladribine infusion end, on 1-5 day"
16112112|NCT02072811|Drug|Consolidation, I HAM cycle|"Ara-C 3g/m2; 3h infusion iv every 12h on 1,2,3 days
~Mitoxantrone 10mg/m2; 0,5h infusion iv on 3,4,5 days"
16112113|NCT02072811|Drug|II Consolidation HiDAraC|• Ara-C 3g/m2 every 12h; 3h infusion iv on 1,3,5 days (+ mobilization of CD34+)
16112114|NCT02072811|Drug|Consolidation, III HiDAraC cycle|"Ara-C 3g/m2 every 12h; 3h infusion iv on 1,3,5 days
~2-CdA 5 mg/m2 2h infusion iv on 1,3,5 days, 2h before Ara-C"
16112115|NCT02072798|Drug|Cefuroxime|iv Cefuroxime 1,5g administered 15-60 minutes before incision versus iv Cefuroxime 1,5g administered after umbilical cord clamping
16112116|NCT02072785|Drug|Vincristine Sulfate Liposome|
16112117|NCT02072785|Drug|Vincristine Sulfate|
16112118|NCT02072772|Behavioral|Positively Smoke Free group treatment|See Arm Description
16112119|NCT02072772|Behavioral|Standard Care|See Arm Description
16112120|NCT02072759|Dietary Supplement|Carnitine supplement|"Carnitine supplement (oral ingestion with meals)
~Total dosage of 2g carnitine per day for 36 days.
~1 carnitine supplement at breakfast (500mg)
~1 carnitine supplement at lunch (500mg)
~2 carnitine supplements at diner (2x 500mg=1000mg)"
16112121|NCT02072759|Dietary Supplement|Placebo|
16112122|NCT02072746|Dietary Supplement|Zinc|
16112123|NCT02072746|Dietary Supplement|Placebo|
16112124|NCT02072733|Other|Comprehensive geriatric assessment|Intervention is planned to be based on the findings of the geriatric assessment and could include optimizing on comorbidity, planning of physical exercise, improvement of the social situation and nutritional status.
16112125|NCT02072720|Drug|Bevacizumab|patients will receive bevacizumab (3mg/kg/wk) starting from the identified induction time point of VEGF expression
16112126|NCT02072707|Procedure|Epicardial VT ablation|Combined Epicardial and Endocardial VT Ablation
16112127|NCT02072707|Procedure|Endocardial VT Ablation|Endocardial Only VT ablation
16112128|NCT02072694|Other|75 grams of glucose plus water solution|"A solution composed by 75 grams of glucose and water at ambient temperature is administered to each volunteer, being of the with obesity group or the without obesity group, as follow:
~300 mL final volume of the solution.
~Time of oral ingestion inferior than 2 minutes.
~30 minutes before the radiopharmaceutical injection.
~12 hours fasting minimum."
16112129|NCT02072694|Other|Pure water|"Pure water at ambient temperature is administered to each volunteer, being of the with obesity group or the without obesity group, as follow:
~300 mL final volume of the solution.
~Time of oral ingestion inferior than 2 minutes.
~30 minutes before the radiopharmaceutical injection.
~12 hours fasting minimum."
16112130|NCT02072668|Drug|rivaroxaban|Subject will receive rivaroxaban 20mg PO daily for 4 weeks and then matching placebo 1 PO daily for 4 weeks, with a 2-week wash out period in between the two treatment phases. Both of the two treatments will be in capsule form OR Subject will receive placebo 1 PO daily for 4 weeks, then rivaroxaban 20mg PO daily for 4 weeks, with a 2-week wash out period in between the two treatment phases. Both of the two treatments will be in capsule form.
16112292|NCT02071511|Procedure|Ablation of ventricular arrhythmias + renal denervation|Intervention group: Ablation of ventricular arrhythmias + renal denervation
16112299|NCT02071433|Procedure|Femoral nerve blockade|
16112131|NCT02072668|Drug|placebo|Subject will receive rivaroxaban 20mg PO daily for 4 weeks and then matching placebo 1 PO daily for 4 weeks, with a 2-week wash out period in between the two treatment phases. Both of the two treatments will be in capsule form OR Subject will receive placebo 1 PO daily for 4 weeks, then rivaroxaban 20mg PO daily for 4 weeks, with a 2-week wash out period in between the two treatment phases. Both of the two treatments will be in capsule form.
16112132|NCT02072655|Procedure|socio-aesthetic care|"care of the face
~skin cleansing with cleansing milk to remove impurities
~a gentle scrub to exfoliate and cleanse the skin
~a relaxing massage
~moisturizing mask
~application of a moisturizer suited to specific patient skin: skin reactivity, dehydration ...
~care manicure / pedicure,
~massages
~makeup, advice (scarves, wigs care products adapted to the skin changes ...) and helping relationship."
16112133|NCT02072642|Device|active light therapy : Light therapy: DayVia lamp 10000 lux|4 weeks of active light therapy with DayVia lamp 10000 lux
16112134|NCT02072642|Device|Placebo light therapy|4 weeks with Placebo light therapy
16112135|NCT02072629|Other|Training of VHVs in iCCM|Village Health Volunteers will be trained in Integrated Community Case Management (iCCM) of childhood illness
16112136|NCT02072616|Other|Pancreatic adenocarcinoma diagnosis|
16112137|NCT02072603|Other|HITSystem|"Online, automated program designed to overcome current EID barriers by providing efficient prospective tracking of HIV-exposed infants and triggering electronic action alerts for both EID providers and lab technicians when time sensitive interventions are overdue for specific infants."
16112138|NCT02072603|Other|Standard of Care|current procedures that follow Kenyan National EID guidelines to diagnose and manage HIV infection among HIV-exposed infants.
16112139|NCT02072577|Behavioral|Video|"The student watched the video prepared individually in the ward where they were interned.
~After this step, the student demonstrated again the procedure for oral hygiene.
~At this point the researcher also observed the sequence, movements and technical procedures used to analyze the steps of oral hygiene, using the same instrument for such employee initially."
16112140|NCT02072564|Other|Questionnaire|Questionnaire with 100 questions divided into different groups: general data, work, physical activity, character, hobbies, disease and diet.
16112141|NCT02072525|Biological|Menveo®|One dose administered intramuscularly (IM) in the upper left deltoid of the arm.
16112142|NCT02072525|Biological|Boostrix®|One dose administered intramuscularly (IM) in the upper right deltoid of the arm.
16112143|NCT02072525|Biological|Pneumovax 23®|One dose administered intramuscularly (IM) in the non-dominant deltoid of the arm.
16112144|NCT02072525|Biological|Prevnar 13®|One dose administered intramuscularly (IM) in the non-dominant deltoid of the arm.
16112145|NCT02072512|Drug|Fulvestrant|Fulvestrant 500mg I.M. Once/28days,until progression or unacceptable toxicity develops
16112146|NCT02072512|Drug|Goserelin|goserelin 3.6mg subcutaneously every 28(± 3) days
16112147|NCT02072512|Drug|Anastrozole|Anastrozole 1mg P.O. once daily, until progression or unacceptable toxicity develops
16112148|NCT02072512|Drug|Goserelin|goserelin 3.6mg subcutaneously every 28(± 3) days
16112149|NCT02072499|Procedure|KTP Green Light Prostatectomy|
16112150|NCT02072499|Device|Green Light|
16112151|NCT02072499|Procedure|Open prostatectomy|
16112152|NCT02072486|Other|Laboratory Biomarker Analysis|Correlative studies
16112153|NCT02072486|Drug|Sorafenib Tosylate|Given PO
16112154|NCT02072473|Procedure|Coronary sinus / left-sided slow pathway ablation|"Patients with unsuccessful right-sided slow pathway ablation attempt will undergo a stepwise:
~coronary sinus slow pathway ablation, which, if unsuccessful, will be followed by
~left-sided slow pathway ablation, using trans-septal approach."
16112155|NCT02072460|Other|electromyography|
16112156|NCT02072460|Other|electroencephalography|
16112157|NCT02072460|Other|approaches from psychophysics|
16112158|NCT02072447|Drug|YH4808 PO and [14C]-YH4808 IV|
16112159|NCT02072434|Drug|Edoxaban|Edoxaban 30 mg tablets for oral administration
16112160|NCT02072434|Drug|Warfarin|Warfarin tablet, 1.0 or 2.5 mg, for oral administration
16112161|NCT02072434|Drug|Enoxaparin|Enoxaparin per label, at prescribed dose until PT INR at least 2.0
16112162|NCT02072421|Procedure|PCI|
16112163|NCT02072408|Drug|aflibercept|"Three monthly intravitreal aflibercept (2mg) injections
~Five bimonthly intravitreal aflibercept (2mg) injections
~Rescue treatment: Verteporfin photodynamic therapy
~Loss of five ETDRS letters or one Snellen line of vision from baseline
~Presence of subretinal fluid or intraretinal fluid despite three consecutive (monthly or bimonthly) aflibercept injection
~Presence of active polyp on indocyanine green angiography"
16112164|NCT02072395|Procedure|Plication|Plication of the stomach will be performed in conjunction with placement of a gastric band.
16112165|NCT02072382|Drug|Metformin|metformin 850mg twice a day for eight weeks
16112166|NCT02072382|Drug|Placebo|
16112167|NCT02072369|Other|VAEDA Glove|Voice And EMG-Driven Actuated glove used during training
16112168|NCT02072369|Other|Occupational Therapy|novel upper extremity occupational therapy focused on the hand
16112169|NCT02072356|Radiation|yttrium Y 90 glass microspheres|Given Interartrial
16112170|NCT02072356|Other|laboratory biomarker analysis|Alpha-fetoprotein assay
16112171|NCT02072343|Device|No-DCCM|
16112172|NCT02072343|Device|DCCM|
16112173|NCT02072343|Other|Water 5ml in tracheal tube|
16112174|NCT02072343|Other|Water 10ml in tracheal tube|
16112175|NCT02072330|Drug|TAK-536CCB|TAK-536CCB 20 mg/5 mg ＋Hydrochlorothiazide placebo tablets
16112176|NCT02072330|Drug|TAK-536CCB + Hydrochlorothiazide|TAK-536CCB 20 mg/5 mg and Hydrochlorothiazide 6.25 mg tablets
16112177|NCT02072330|Drug|Hydrochlorothiazide|TAK-536CCB placebo and Hydrochlorothiazide 6.25 mg tablets
16112178|NCT02072330|Drug|Hydrochlorothiazide|TAK-536CCB placebo and Hydrochlorothiazide 6.25 mg tablets x2
16112179|NCT02072330|Drug|TAK-536CCB + Hydrochlorothiazide|TAK-536CCB 20 mg/5 mg and Hydrochlorothiazide 6.25 mg tablets x2
16112180|NCT02072317|Drug|taxel plus raltitrexed|taxol 135 mg/m2, raltitrexed 3 mg/m2 ivgtt d1, every three weeks for a cycle
16112181|NCT02072317|Drug|taxol|taxol 135 mg/m2, every three weeks for a cycle
16112296|NCT02071459|Drug|L-Threo DOPS|initial dose titration period (4 weeks) followed by 8 weeks at the max tolerated dose
16113408|NCT02062632|Other|Quality-of-Life Assessment|Ancillary studies
16112182|NCT02072304|Behavioral|web-based CBT|A cognitive behavioral program in 8 weeks that will provide participants with the following: online interactive tools to do their homeworks and guidance on using cognitive and behavioral strategies to help reduce depressive symptoms, information about the depressive symptoms and cognitive behavioral therapy
16112183|NCT02072304|Behavioral|supportive care|supportive care group will receive supportive care for treating depression by e-mail per a week for 8 weeks with the following: psychoeducation about depression, stigma of mental illness, distraction technique, emotional regulation, active scheduling.
16112184|NCT02072291|Drug|Nifedipine|PO Nifedipine 5mg single dose
16112185|NCT02072278|Drug|Vortioxetine 10 mg|
16112186|NCT02072278|Drug|Vortioxetine 20 mg|
16112187|NCT02072278|Drug|Escitalopram 15 mg|
16112188|NCT02072278|Drug|Placebo|
16112189|NCT02072265|Device|Infrared thermal images|
16112190|NCT02072252|Behavioral|Mobile Phone Application|Mobile phone app teaching cognitive behavioral skills
16112191|NCT02072239|Device|Angioshield|The Angioshield wrap provides external structural support for the saphenous vein graft used in CABG surgery and is intended to prevent over distention of the graft under arterial pressure, potentially improving graft patency and reducing the likelihood of graft failure.
16112192|NCT02072226|Drug|Alteplase|Single dose of alteplase will be administered at 0.9 milligrams per kilogram (mg/kg) IV (maximal dose of 90 mg).
16112193|NCT02072226|Drug|Alteplase Placebo|Single dose of alteplase placebo will be administered as IV injection.
16112194|NCT02072226|Drug|Aspirin|Single dose of aspirin will be administered at 325 mg orally.
16112195|NCT02072226|Drug|Aspirin Placebo|Single dose of aspirin placebo will be administered orally.
16112196|NCT02072213|Drug|GL2702 GLARS-NF1|0.4mg once a day
16112197|NCT02072213|Drug|Omix Ocas|0.4mg once a day
16112198|NCT02072200|Drug|Lodotra®|Single arm will be received below oral 10mg tablet daily and maximum 10mg/d depending on the clinical symptoms and the patient's response
16112199|NCT02072187|Dietary Supplement|Active|
16112200|NCT02072187|Dietary Supplement|Placebo|
16112201|NCT02072174|Drug|Anaferon for Children|Anaferon for children: For oral use.
16112202|NCT02072161|Drug|ETC-1002|ETC-1002 capsules, taken once daily oral
16112203|NCT02072161|Drug|Placebo|Placebo capsules, taken once daily oral
16112204|NCT02072161|Drug|Statin Therapy|Patients remained on ongoing statin therapy (not study provided) of either Atorvastatin 10mg or 20mg; Simvastatin 5mg, 10mg or 20mg; Rosuvastatin 5mg or 10mg; or Pravastatin 10mg, 20mg or 40mg.
16112205|NCT02072148|Procedure|PET/CT|PET scan or CT scan q 4 months for 5 years
16112206|NCT02072148|Radiation|Radiotherapy|Postoperative XRT 5000 cGy
16112207|NCT02072148|Radiation|Concurrent Chemoradiation|"CCRT with cisplatin 40mg/m2/week IV over approximately 30 minutes, mixed in 250ml normal saline Weekly on Monday or Tuesday any time, or Wednesday prior to radiation
~Postoperative XRT 5000 cGy"
16112208|NCT02072148|Radiation|Concurrent Chemoradiation|"CCRT with cisplatin 40mg/m2/week IV over approximately 30 minutes, mixed in 250ml normal saline Weekly on Monday or Tuesday any time, or Wednesday prior to radiation
~Postoperative XRT 5600 cGy"
16112209|NCT02072135|Drug|Exparel|
16112210|NCT02072096|Drug|Glimepiride|Administered orally
16112211|NCT02072096|Drug|Metformin|Administered orally
16112212|NCT02072096|Drug|Pioglitazone|Administered orally
16112213|NCT02072096|Drug|Acarbose|Administered orally
16112214|NCT02072096|Drug|Linagliptin|Administered orally
16112215|NCT02072096|Drug|Sitagliptin|Administered orally
16112216|NCT02072096|Drug|Liraglutide|Administered subcutaneously (SC)
16112217|NCT02072096|Drug|Insulin Glargine|Administered SC
16112218|NCT02072096|Drug|Exenatide once weekly (QW)|Administered SC
16112219|NCT02072096|Drug|Exenatide twice daily (BID)|Administered SC
16112220|NCT02072083|Drug|Dexmedetomidine|via intranasal route 1 mcg/kg
16112221|NCT02072083|Drug|Ketamine|via intranasal route 7,5 mg/kg ketamine and 0,1 mg/kg midazolam
16112222|NCT02072070|Biological|TissueGene-C|TissueGene-C at 1.8 x 10^7 cells
16112223|NCT02072070|Drug|Placebo|Placebo control(Normal Saline)
16112224|NCT02072057|Drug|Ruxolitinib|
16112225|NCT02072044|Drug|Anlotinib|Anlotinib p.o. qd
16112226|NCT02072031|Drug|Anlotinib|Anlotinib p.o. qd
16112227|NCT02072031|Drug|Sunitinib maleate|Sunitinib 50 mg p.o. qd
16112228|NCT02072018|Drug|H-100|H-100 is a new compound to be applied to Peyronie's disease tissue with the intention of reducing disease symptoms.
16112229|NCT02072018|Drug|Placebo|Placebo is an established, standard compound to be applied to Peyronie's disease tissue that will have no effect on disease symptoms.
16112230|NCT02072005|Other|mSMART smartphone application|This application is an interface that provides subjects with information and questionnaires related to their medication.
16112231|NCT02071979|Device|Autologous PRP Gel|Autologous PRP Gel is prepared using the Arteriocyte Magellan® System (510(k) approved), an Autologous Platelet Separator Instrument, which is a microprocessor-controlled centrifuge designed to be used in the clinical laboratory or intraoperatively at point of care for the safe and rapid preparation of platelet poor plasma and platelet concentrate (platelet rich plasma) from a small sample of blood. The Arteriocyte Magellan® automatically and quickly separates PRP from anticoagulated blood and dispenses it into a separate sterile syringe. The prepared PRP is then activated (by mixing with thrombin and calcium chloride) and sprayed directly on the area to be treated.
16112232|NCT02071979|Device|Autologous PRP Injections|Autologous PRP Gel is prepared using the Arteriocyte Magellan® System (510(k) approved), an Autologous Platelet Separator Instrument, which is a microprocessor-controlled centrifuge designed to be used in the clinical laboratory or intraoperatively at point of care for the safe and rapid preparation of platelet poor plasma and platelet concentrate (platelet rich plasma) from a small sample of blood. The Arteriocyte Magellan® automatically and quickly separates PRP from anticoagulated blood and dispenses it into a separate sterile syringe. The prepared PRP is then drawn into multiple small syringes and injected directly into the wound bed or the skin surrounding it.
16112293|NCT02071498|Device|Pillbox app named ALICE|Participants in the experimental group were given a BQ tablet or an iPad with the ALICE app installed and personalised according to the medications they had been prescribed as listed in their medical record
16112233|NCT02071979|Device|Autologous PRP Gel plus PRP Injections|Autologous PRP Gel is prepared using the Arteriocyte Magellan® System (510(k) approved), an Autologous Platelet Separator Instrument, which is a microprocessor-controlled centrifuge designed to be used in the clinical laboratory or intraoperatively at point of care for the safe and rapid preparation of platelet poor plasma and PRP from a small sample of blood. The Arteriocyte Magellan® automatically and quickly separates PRP from anticoagulated blood and dispenses it into a separate sterile syringe. The prepared PRP is then divided into equal parts and half is drawn into multiple small syringes and injected directly into the skin surrounding the wound bed, half is activated (by mixing with thrombin and calcium chloride) and sprayed the wound bed.
16112234|NCT02071979|Procedure|Standard Wound Care|Subjects in the control group will receive Standard Wound Care treatment for chronic wounds according to accepted medical practices.
16112235|NCT02071966|Drug|Ticagrelor|Comparison of Ticagrelor with another anti-platelet drug (Clopidogrel)
16112236|NCT02071966|Drug|Clopidogrel|Comparison of Clopidogrel with another anti-platelet drug (Ticagrelor)
16112237|NCT02071953|Device|Experimental adhesive w/out phosphoric acid in post. rest.|Experimental adhesive without phosphoric acid in posterior restorations
16112238|NCT02071953|Device|Experimental adhesive with phosphoric acid in post. rest.|Experimental adhesive with phosphoric acid in posterior restorations
16112239|NCT02071940|Drug|PLX3397|PLX3397 capsules 1000mg/day as monotherapy
16112240|NCT02071927|Drug|CB-839|Single-agent CB-839
16112241|NCT02071927|Drug|CB-Aza|CB-839 in combination with standard dose azacitidine
16112242|NCT02071914|Drug|CT-P27|Influenza A treatment drug.
16112243|NCT02071914|Drug|Placebo|Placebo.
16112244|NCT02071901|Drug|eltrombopag olamine|Given PO
16112245|NCT02071888|Drug|CB-839|Glutaminase inhibitor
16112246|NCT02071888|Drug|CB-839 and low dose dexamethasone|CB-839 and low dose dexamethasone
16112247|NCT02071888|Drug|CB-839, pomalidomide, and low dose dexamethasone|CB-839, pomalidomide, and low dose dexamethasone
16112248|NCT02071875|Device|Nautilus NeuroWaveTM recording|Nautilus NeuroWaveTM recording 15 minute recording with Nautilus NeuroWave Neurodiagnostic .
16112249|NCT02071862|Drug|CB-839|CB-839 monotherapy
16112250|NCT02071862|Drug|Pac-CB|CB-839 in combination with standard dose paclitaxel
16112251|NCT02071862|Drug|CBE|CB-839 in combination with standard dose everolimus
16112252|NCT02071862|Drug|CB-Erl|CB-839 in combination with standard dose erlotnib
16112253|NCT02071862|Drug|CBD|CB-839 in combination with standard dose docetaxel
16112254|NCT02071862|Drug|CB-Cabo|CB-839 in combination with standard dose cabozantinib
16112255|NCT02071849|Device|HAART 200 Aortic Valve Annuloplasty Device|Surgical repair of bicuspid aortic valve using the HAART 200 Aortic Valve Annuloplasty Device .
16112256|NCT02071836|Behavioral|Right Turns web application|
16112257|NCT02071836|Behavioral|Treatment as usual|
16112258|NCT02071823|Drug|BIA 9-1067|A single oral dose of 50 mg (2 x 25 mg capsules) was administered in the morning of each study period under fasting or fed conditions. The two single dose administrations were separated by a wash-out of 7 days.
16112259|NCT02071810|Drug|BIA 9-1067|
16112260|NCT02071810|Drug|Placebo|
16112261|NCT02071797|Device|Induced Therapeutic Hypothermia|Head to head, direct comparator of two standard care devices/treatments (RhinoChill versus Blanketroll lll) to assess time to induced therapeutic hypothermia
16112262|NCT02071771|Device|Nelfilcon A toric contact lenses|
16112263|NCT02071771|Device|Etafilcon A toric contact lenses|
16112264|NCT02071758|Biological|LEISH-F3 + SLA-SE|
16112265|NCT02071758|Biological|LEISH-F3 + GLA-SE|
16112266|NCT02071732|Device|real repetitive Transcranial Magnetic Stimulation|
16112267|NCT02071732|Device|sham repetitive Transcranial Magnetic Stimulation|This sham stimulation is not true stimulation.
16112268|NCT02071706|Device|PET/MRI system|Enrolled subject undergoes PET/MR scan
16112269|NCT02071680|Other|Iodine-123 Meta-iodobenzylguanidine|"A single injection of the 123I-mIBG will be given. Imaging will be done twice following injection: at 0120 minutes and 3-5 hours. The timing is dependent on the specific participant and imaging characteristics.
~The imaging is done for approximately 24 minutes at each time point."
16112270|NCT02071667|Other|Blood draw|
16112271|NCT02071654|Device|Venus P-valve transcatheter implantation|Percutaneous implantation of Venus-P valve to treat RVOT stenosis patients
16112272|NCT02071641|Drug|Sunitinib|
16112273|NCT02071615|Drug|Methylphenidate 20 mg tablet given once by mouth|3-arm, single-drug dosage comparison study
16112274|NCT02071615|Drug|modafinil 200mg tablet given once by mouth|3-arm, single-drug dosage comparison study
16112275|NCT02071615|Drug|caffein 200mg tablet given once by mouth|3-arm, single-drug dosage comparison study
16112276|NCT02071615|Drug|placebo|
16112277|NCT02071602|Drug|CD-NP|Randomized 1:1:1
16112278|NCT02071589|Drug|Nifedipine soft gelatine capsules|3 Adalat capsules of 10 mg each one
16112279|NCT02071589|Drug|Nifedipine oral solution|6 mL of Nife Par solution
16112280|NCT02071576|Device|Proscan|One device (500 Hz Excimer Laser - TENEO) with one intervention (Proscan)
16112281|NCT02071563|Dietary Supplement|CSB14|
16112282|NCT02071563|Dietary Supplement|RUSF1|
16112283|NCT02071563|Dietary Supplement|SC+|
16112284|NCT02071550|Device|FORESİGHT cerebral oxygen monitor and INVOS cerebral oxygen monitor|
16112285|NCT02071550|Device|FORESIGHT and INVOS monitor|
16112286|NCT02071537|Drug|Chloroquine|Dose is 50, 100, 150, and 200 mg per day cohorts. It is given one week prior to the initiation of chemotherapy and then given for four 21 day cycles in combination with chemotherapy.
16112287|NCT02071537|Drug|Carboplatin|Administered day 1 of each 21 day cycle for 4-6 cycles.
16112288|NCT02071537|Drug|Gemcitabine|Administered days 1 and 8 of each 21 day cycle for 4-6 cycles.
16112289|NCT02071524|Drug|Group Colloid|Group Colloid: cristalloid 1:2 (gelofusine: ringer lactate)
16112290|NCT02071524|Drug|Cristalloid administration|Only Ringer Lactate administration
16112291|NCT02071511|Procedure|Ablation of ventricular arrhythmias|control group: Ablation of ventricular arrhythmias
16112294|NCT02071498|Other|oral and written information|oral and written information about the most common errors of patients
16112300|NCT02071420|Behavioral|Active Workstation Intervention|Participants in the experimental group will receive a seated active workstation at their work setting for 16 weeks.
16112301|NCT02071420|Behavioral|Ergonomic Intervention|Participants of both arms will receive a face to face ergonomic workstation optimization intervention. This consultation will take 30 minutes to complete and will be performed at the participant's actual work station.
16112302|NCT02071420|Behavioral|Email Intervention|Participants of both arms will receive three emails per week for 16 weeks. Messages will be consistent with what they hear in the ergonomic intervention (e.g., encourage taking breaks from sitting at work and adjusting posture to be in line with ergonomic principles).
16112303|NCT02071420|Device|Bluetooth enabled device (Wahoo Fitness Blue SC sensor) and accompanying iPod application.|
16112304|NCT02071407|Drug|Midazolam|"For patients allocated into group N2, 2 mg midazolam will be injected intravenously, and then it will be given at 0.05-0.1 mg/(kg·h) by intravenous infusion. If a surgery is needed, infusion of midazolam will begin 3 hours after the operation and continue for at least 72 hours. During the sedation with midazolam, BIS should be kept at 60 to 80.
~Morphine can be used to supply adequate analgesia."
16112305|NCT02071407|Drug|Placebo|
16112306|NCT02071394|Drug|Xenon gas|Inhalation via endotracheal tube of 50% xenon for 18 hours, including during transport for outborn babies, starting within 5 hours after birth.
16112307|NCT02071394|Other|Whole body cooling|Cooling of baby to reduce rectal temperature to 33.5 degree Centigrade(standard treatment), including during transport for outborn babies, starting within 3 hours after birth.
16112308|NCT02071381|Drug|DW330SR 45mg|
16112309|NCT02071381|Drug|DW1030 75mg|
16112310|NCT02071368|Drug|Canagliflozin, 300 mg|Each tablet contains canagliflozin (CANA) of 300 mg to be taken orally (by mouth).
16112311|NCT02071368|Drug|Metformin XR, 500 mg|Each tablet contains metformin extended release (MET XR), 500 mg, to be taken orally (by mouth).
16112312|NCT02071368|Drug|CANA/MET XR FDC, Formulation 1, 150 mg/500|Each tablet contains 150 mg of canagliflozin and 500 mg of metformin HCl granulate, formulation 1, to be taken orally.
16112313|NCT02071368|Drug|CANA/MET XR FDC, Formulation 2, 150 mg/500 mg|Each tablet contains 150 mg of canagliflozin and 500 mg of metformin HCl granulate, formulation 2, to be taken orally.
16112314|NCT02071355|Drug|TMC435 100 mg|Participants will receive TMC435 100 mg capsule once daily from Day 1 to Day 7 after food.
16112315|NCT02071355|Drug|TMC435 150 mg|Participants will receive TMC435 150 mg capsule once daily from Day 1 to Day 7 after food.
16112316|NCT02071342|Procedure|angioplasty|patients with acute coronary syndrome and coronary angioplasty with bioresorbable vascular scaffold.
16112317|NCT02071329|Drug|Vaccine FP-01.1|
16112318|NCT02071329|Drug|Placebo|
16112319|NCT02071329|Other|Virus Challenge|
16112320|NCT02071316|Drug|Hexacapron( Tranexamic acid)|1. Treatment group - receive I.V. Esomeprazole 80 mg once and then 8mg/h continuously with concurrent hexacapron( Tranexamic acid) I.V. every 6 hours until 72 hours and then the patient continue oral treatment 6 g /day for 7 days.
16112321|NCT02071316|Drug|esomeprazole|2. Standard of care group - receive I.V. Esomeprazole 80 mg once and then 8mg/h continuously
16112322|NCT02071303|Drug|Tramadol|Tramadol 100mg will be given to 70 women before the procedure.
16112323|NCT02071303|Drug|Celecoxib|Celecoxib 200mg will be given to 70 women before the procedure.
16112324|NCT02071303|Drug|Placebo|A placebo will be given to 70 women before the procedure.
16112325|NCT02071290|Device|Pneumatic tourniquet|"Four cycles of brief occlusion of bloodflow to the thigh (5 minutes) followed by reperfusion (5 minutes) using a pneumatic tourniquet
~Remote Ischemic Conditioning"
16112326|NCT02071277|Other|Pressure targeted modes|Intervention involving three different pressure-targeted modes (APRV, BIPAP, and BIPAPassist) each in a random order generated by a computer on one ventilator. Each mode will be studied for 20 minutes.
16112327|NCT02071264|Behavioral|HIV/STI intervention|The intervention covers HIV101 information, reproductive health and human rights national policies, goal setting activities as individuals and as a group, results of prior research on ethics of doing research with sex workers.
16112328|NCT02071251|Procedure|Prospective wound complication protocol|The skin and subcutaneous tissues were incised using a scalpel or cutting electrocautery. Use of coagulation current on the skin or subcutaneous tissues was not allowed, except focally to attain hemostasis. At the conclusion of surgery, a 7mm Jackson-Pratt drain was placed below Camper's fascia, which in turn was closed with 3-0 plain catgut suture. The skin was closed with staples. Dressings were retained for at least twenty-four hours. Staples were to be retained for at least two weeks.
16112329|NCT02071238|Behavioral|Pamphlet|Written pamphlet outlining the risks of surgery as discussed in consultation.
16112330|NCT02071238|Behavioral|Group Consultation|Informed consent discussion in group-format
16112331|NCT02071225|Drug|bendamustine|70 milligrams per square meter (mg/m^2) given by intravenous (IV) infusion on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of subsequent cycles.
16112332|NCT02071225|Drug|obinutuzumab|1000 mg given by IV infusion on Days 1, 8, and 15 of Cycle 1 and on Day 1 of subsequent cycles.
16112333|NCT02071212|Drug|Ticagrelor|Loading dose 180 mg . Maintainance dose 90 mg BID
16112334|NCT02071199|Drug|1X ACCS (Amnion-derived Cellular Cytokine Solution)|1X ACCS will be applied to the gingival margin daily 5 days per week for 2 weeks
16112335|NCT02071199|Drug|Normal saline|Saline will be applied to the gingival margin daily 5 days per week for 2 weeks
16112336|NCT02071199|Drug|0.3X ACCS|0.3X ACCS will be applied to the gingival margin daily 5 days per week for 2 weeks
16112337|NCT02071186|Device|Virtual Reality training|"Subjects will train with the VR system at the Tel Aviv Sourasky Medical Center 3 times per week for 6 weeks with each session lasting approximately 30 minutes.
~To assure participants' safety and maintaining progress, training with the VR will be individual and provided by qualified physiotherapists, who use the system on a daily basis."
16112338|NCT02071186|Other|Computerized Cognitive Remediation|Subjects in this study will train with the AttenGo program at home 3-5 times per week for 6 weeks with each session lasting approximately 30 minutes.
16112339|NCT02071186|Other|Standard of care|
16112384|NCT02070809|Procedure|tissue-engineered skin method|This method is composite of skin grafting over human acellular dermal matrix scaffold the investigators used before with skin basal cell as seed cells, moreover it was finished in the surgery without culturing the cells
16112340|NCT02071173|Device|ACUITY X4 quadripolar coronary venous lead and RELIANCE 4-FRONT defibrillation lead|"The ACUITY X4 leads are intended for chronic left ventricular pacing and sensing. The leads have 3 tip configuration designs (straight tip, short tip spiral, and long tip spiral), which is intended to provide choices for patients with different anatomies.
~The RELIANCE 4-FRONT leads are designed for right-side heart applications within the ventricle, atrium, and superior vena cava. It is intended for permanent sensing, pacing, and defibrillation when used with a compatible implantable cardioverter defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D).
~Subjects were allowed to receive both the ACUITY X4 and RELIANCE 4-FRONT lead."
16112341|NCT02071160|Drug|Melatonin|Melatonin is administered to the melatonin/hypothermia group (n=15) in a dose of 10 mg/kg daily for a total of 5 doses starting immediately at enrollment. Melatonin tablets (1 or 3 mg/tablet) (Puritan's Pride,Oakdale, NY, USA) are crushed, then dissolved in 5-10 ml of distilled water , then administered via an orogastric tube.
16112342|NCT02071147|Other|No Clinical Follow up|
16112343|NCT02071147|Other|Quality of Life questionnaire|
16112344|NCT02071147|Other|Patient satisfaction Questionnaire|Conducted at Research clinic.
16112345|NCT02071134|Device|Deep Brain Stimulation (DBS)|Subjects receiving Deep Brain Stimulation (DBS) for the treatment of their Parkinson's disease symptoms will be offered participation in this registry.
16112346|NCT02071121|Drug|BIIB061|BIIB061 capsules for oral administration
16112347|NCT02071121|Drug|Placebo|BIIB061 matching placebo capsules
16112348|NCT02071121|Drug|14C-BIIB061|Radiolabeled containing 14C-BIIB061 ≤ 500 nCi.
16112349|NCT02071108|Device|Shockwave Lithoplasty System|
16112350|NCT02071095|Drug|Arm A: Poly-ICLC|Poly-ICLC (Hiltonol®, Oncovir) Administration - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with 1.4 mg of Poly-ICLC (Hiltonol®, Oncovir). Each subject will receive a total of 2 SC doses of Poly-ICLC. The volume of each injection is 0.7ml. The investigators who are blinded will not be present at the time of injection by the study nurse.
16112351|NCT02071095|Drug|Arm B: Normal Saline|Normal Saline - On days 1 and 2, patients randomized to this arm will be injected subcutaneously in the arm with normal saline obtained from the Rockefeller University Pharmacy. Each subject will receive a total of 2 SC doses of normal saline. The volume of each injection is 0.7ml. The investigators who are blinded will not be present at the time of injection by the study nurse.
16112352|NCT02071082|Drug|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food
16112353|NCT02071069|Drug|Cetuximab|400mg/m2 d1,250mg/m2 every week or 500mg/m2 every 2 weeks
16112354|NCT02071069|Drug|irinotecan|180 mg/m2 IV every 2 weeks
16112355|NCT02071069|Drug|fluorouracil|400mg/m2 on day 1 and 2400mg/m2 civ46h every 2 weeks
16112356|NCT02071043|Drug|Capecitabine|Capecitabine 1000 mg/m2 ，orally taken 30 minutes after meal, bid ， d 1~14 every 3
16112357|NCT02071043|Drug|Oxaliplatin|Oxaliplatin：130mg/m2， iv infusion over 2h，d1,every 3 weeks
16112358|NCT02071030|Procedure|Third molar removal|Surgically removing the third molar in the lower jaw
16112359|NCT02071004|Drug|DS-1040b|IV of 6 mg given once over 30 minutes
16112360|NCT02071004|Drug|Aspirin|Dispersible tablet, 300mg & 75 mg, once daily for 5 days
16112361|NCT02070991|Drug|Macitentan|oral tablet, 10 mg once daily
16112362|NCT02070991|Drug|Placebo|matching placebo
16112363|NCT02070978|Drug|Atacicept 75 mg|Participants who received atacicept 75 milligram (mg) as once-weekly subcutaneous injection in the core study ADDRESS II continued to receive this dose during this LTE study. Participants in this reporting arm received the medication up to a maximum of 143.7 weeks.
16112364|NCT02070978|Drug|Atacicept 150 mg|Participants who received placebo in the core study ADDRESS II switched to receive atacicept 150 mg as once-weekly subcutaneous injection for up to a maximum of 97.7 weeks during this LTE study.
16112365|NCT02070978|Drug|Atacicept 150 mg|Participants who received atacicept 150 mg in core study ADDRESS II continued to receive atacicept 150 mg as once-weekly subcutaneous injection during this LTE study up to a maximum of 97.9 weeks.
16112366|NCT02070965|Drug|DFD01 Spray|
16112367|NCT02070965|Drug|Comp01 Lotion|
16112368|NCT02070952|Radiation|CyberKnife Stereotactic Ablative Body Radiation Therapy|The prescribed planned tumor volume (PTV) dose of 36.25 Gy shall be given in 5 fractions using CyberKnife Hypofractionated Stereotactic Ablative Body Radiation Therapy. PTV will be defined per parameters outlined in the protocol and will at minimum include the entire prostate gland.
16112369|NCT02070939|Drug|PF-06260414|Subjects will receive single doses of 1,3,6,30,100,200, 400 mg of PF-06260414 (solution) in a dose escalating format
16112370|NCT02070939|Drug|Placebo|Subjects will receive single doses of PF-06260414 matching placebo (solution) in a dose escalation format
16112371|NCT02070939|Drug|PF-06260414|Subjects will receive PF-06260414 doses (solution) twice daily for 14 days
16112372|NCT02070939|Drug|Placebo|Subjects will receive PF-06260414 matching placebo doses (solution) of 3, 10, 30, 100mg BID and 60 mg QD for 14 days
16112373|NCT02070939|Drug|PF-06260414|Japanese subjects may receive the highest dose of PF-06460414 tested in non Japanese cohort twice daily for 14 days
16112374|NCT02070939|Drug|Placebo|Japanese subjects may receive PF-06260414 matching placebo doses (solution) twice daily for 14 days
16112375|NCT02070900|Device|POC CD4|Point of Care device for CD4 count testing (to be used as a clinical monitoring tool)
16112376|NCT02070900|Other|Programmatic Mentoring|Programmatic Mentoring aimed at messaging around CD4 count to encourage retention on lifelong ART for PMTCT patients, administered by trained clinical mentors
16112377|NCT02070874|Behavioral|telehealth enhanced pain management|
16112378|NCT02070861|Other|Ventricular pacing and passive leg raise|Ventricular pacing and passive leg raise
16112379|NCT02070848|Other|Session 1-4|Familiarization sessions to knee-extensor exercise separated by 72h recovery
16112380|NCT02070848|Other|Session 4|After the last familiarization session, 1 maximal incremental test on a bicycle, followed by 72h rest
16112381|NCT02070848|Other|Session 5|2 maximal incremental tests of knee-extension exercise (concentric vs eccentric), separated by 3h rest.
16112382|NCT02070835|Device|ReCell®|ReCell® and skin graft
16112383|NCT02070835|Procedure|skin graft|split-thickness skin graft
16112385|NCT02070809|Procedure|split-thickness skin graft method|This method is traditional split-thickness skin graft
16112386|NCT02070796|Drug|Rotigotine PR2.2.1|"Treatment A:
~Rotigotine Transdermal patch 2 mg/24 hr (10 cm^2) Test drug product PR2.2.1. Single application of 1 patch for 24 hours."
16112387|NCT02070796|Drug|Rotigotine PR2.1.1|"Treatment B:
~Rotigotine Transdermal patch 2 mg/24 hr (10 cm^2) Reference drug product PR2.1.1. Single application of 1 patch for 24 hours."
16112388|NCT02070783|Drug|ARA290|
16112389|NCT02070783|Drug|Placebo|
16112390|NCT02070770|Dietary Supplement|Very low calorie diet|
16112391|NCT02070770|Other|Standard weight loss diet|
16112392|NCT02070757|Drug|Ceftolozane/tazobactam|Ceftolozane/tazobactam is an antibacterial consisting of a co-formulation of ceftolozane, a novel antipseudomonal cephalosporin and tazobactam, a well-established beta (β)-lactamase inhibitor (BLI) being developed for the treatment of serious bacterial infections.
16112393|NCT02070757|Drug|Meropenem|Meropenem is a broad spectrum injectable antibiotic widely used to treat serious infections such as ventilator-associated bacterial pneumonia and hospital-acquired bacterial pneumonia.
16112394|NCT02070744|Drug|VX-661|Tablet, oral use
16112395|NCT02070744|Drug|Ivacaftor|Film coated tablet, oral use
16112396|NCT02070744|Drug|Placebo matched to VX-661|Tablet, oral use
16112397|NCT02070744|Drug|Placebo matched to Ivacaftor|Film coated tablet, oral use
16112398|NCT02070731|Device|TriGuard HDH|TAVI with the TriGuard HDH embolic deflection device
16112399|NCT02070718|Drug|Standard Dose Kappa Agonist|
16112400|NCT02070718|Drug|Half Dose Kappa Agonist|
16112401|NCT02070718|Other|Placebo|
16112402|NCT02070705|Procedure|Dynamic Contrast-Enhanced Magnetic Resonance Imaging|Undergo DCE MRI
16112403|NCT02070705|Drug|Ferumoxytol|Given IV
16112404|NCT02070692|Drug|Tamoxifen|7 day course of tamoxifen during an episode of irregular vaginal bleeding
16112405|NCT02070692|Drug|Placebo|7 day course of placebo during an episode of irregular vaginal bleeding
16112406|NCT02070679|Drug|Vitamin E|
16112407|NCT02070666|Behavioral|Protective mechanical ventilation|"Ventilation mode: volume control, pressure control, dual modes (It is allowed to change to a spontaneous mode; a minimum of 5 cmH2O level of support should be used; in case the resulting tidal volume exceeds 6 mL/kg PBW this is accepted. This is not a reason to use more sedation and/or muscle relaxants, or to switch the ventilator to a controlled mode of ventilation).
~Tidal volume: 6 mL/Kg PBW, decreasing 1 mL/kg PBW each step if necessary (steps of 5 minutes), to maintain plateau pressure < 25 cmH2O until a minimum tidal volume of 4 mL/Kg PBW, unless the patient suffers from severe dyspnea or unacceptable acidosis.
~Fraction of inspired oxygen inspired oxygen fraction (FiO2) > 0.21 to maintain oxygen saturation 90-92%.
~PEEP ≥ 5 cmH2O, and optimized to maintain Oxygen saturation (SpO2) 90-92% (left to the discretion of the attending physician).
~Plateau pressure ≤ 25 cmH2O"
16112408|NCT02070666|Behavioral|Control group|"Ventilation mode: volume control, pressure control, dual modes (It is allowed to change to a spontaneous mode, with the level of support adjusted to reach tidal volumes minimum of 8 mL/kg predicted body weight PBW; if it is not possible, the data collection should be continue and an intention-to-treat analysis will be done).
~Tidal volume: minimum 8 mL/kg PBW. It is possible to increase until 10 mL/kg PBW unless plateau pressure increases above 25 cmH2O.
~· FiO2 > 0.21 to maintain oxygen saturation 90-92%.
~PEEP ≥ 5 cmH2O, and optimized to maintain SpO2 90-92% (left to the discretion of the attending physician).
~Plateau pressure ≤ 25 cm H2O."
16112409|NCT02070666|Other|Dead space|Volumetric capnography will be used. Dead space (Vd/Vt) measurements will be taken at baseline and daily after initiation of mechanical ventilation. Nursing and respiratory care activities (including changes to ventilator settings) will be suspended for at least 5 minutes prior to all Vd/Vt measurements.
16112410|NCT02070653|Drug|Ticagrelor|
16112411|NCT02070653|Drug|Placebo|
16112412|NCT02070640|Drug|Injection of indocyanine green (ICG)|2.5 mg of of ICG will be injected intravenously 60-30 minutes prior to surgery in order to visualize the biliary tree using a near-infrared light source and camera. An additional 2.5 mg of IV ICG may be given intraoperatively if fluorescence has faded prior to visualization.
16112413|NCT02070640|Device|Near Infrared Cholangiography Fluorescence (NIRF-C)|These devices are used to identify anatomy, using infrared light that causes the ICG to fluoresce.
16112414|NCT02070627|Drug|Indocyanine Green (ICG)|60-30 minutes prior to cholecystectomy, 2.5 mg of indocyanine green (ICG) will be injected intravenously. An additional 2.5 mg of ICG may be injected intraoperatively if the fluorescence fades prior to imaging.
16112415|NCT02070627|Device|Near Infrared Fluorescence Cholangiography (NIRF-C)|Near infrared fluorescence cholangiography will be performed intraoperatively in order to image anatomy.
16112416|NCT02070588|Device|MRI|MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects
16112417|NCT02070575|Other|blood draw|Venous blood will be collected in an EDTA Vacutainer tubeup to 10 mL and will be immediately put on ice. This sample may be drawn as a stand-alone blood draw. Samples will be centrifuged at 1900g (3000-3200 RPM) for 15 Minutes and the serum aliquoted into freezer vials and stored at -80°C until analysis. In addition patients who have not received treatment for biochemical recurrence after their first draw are eligible for subsequent draws to determine the reproducibility of the test over time.
16112418|NCT02070549|Drug|Trametinib|Given PO
16112419|NCT02070536|Other|sRAGE|
16112420|NCT02070523|Drug|VDCLD regimen|
16112421|NCT02070510|Drug|semaglutide|For oral administration once daily. Doses of 5 mg and 10 mg, respectively, will be given for 7 days followed by 20 mg administered on days 43-84.
16112422|NCT02070510|Drug|lisinopril|For oral administration. A single dose of 20 mg is administered three times either alone or conconmitantly with a perpetrator compound (days 1, 15 and 71).
16112423|NCT02070510|Drug|warfarin|For oral administration. A single dose of 5 mg is administered three times either alone or conconmitantly with a perpetrator compound (days 8, 22 and 78).
16112424|NCT02070510|Drug|placebo|A single dose of SNAC is administered conconmitantly with victim compounds (days 15 and 22).
16112425|NCT02070497|Other|case management|case management group will accept the case manager's service; the control group will just accept the routine care
16112426|NCT02070484|Biological|NuCel|
16112427|NCT02070484|Biological|Demineralized Bone Matrix|
16112428|NCT02070471|Drug|Placebo|Placebo
16112429|NCT02070471|Drug|LC28-0126 Dose A|LC28-0126 Dose A
16112430|NCT02070471|Drug|LC28-0126 Dose B|LC28-0126 Dose B
16112436|NCT02070432|Drug|LUZ11|LUZ11 i.v. administration followed by laser light irradiation
16112437|NCT02070419|Procedure|transarterial chemoembolization|Undergo TACE with doxorubicin-eluting beads
16112438|NCT02070419|Radiation|stereotactic radiosurgery|Undergo SBRT
16112439|NCT02070406|Drug|cyclophosphamide|Given IV
16112440|NCT02070406|Drug|fludarabine phosphate|Given IV
16112441|NCT02070406|Biological|NY-ESO-1 reactive TCR retroviral vector transduced autologous PBL|Given NY-ESO-1 reactive TCR retroviral vector transduced autologous T cells IV
16112442|NCT02070406|Biological|dendritic cell vaccine therapy|NY-ESO-1157-165 peptide pulsed DC vaccine given ID
16112443|NCT02070406|Biological|aldesleukin|Given SC
16112444|NCT02070406|Radiation|fludeoxyglucose F 18|Correlative studies
16112445|NCT02070406|Procedure|positron emission tomography|Correlative studies
16112446|NCT02070406|Other|laboratory biomarker analysis|Correlative studies
16112447|NCT02070393|Radiation|Proton|14-24 Radiation treatments using Protons
16112448|NCT02070380|Drug|MultiHance 0.1 mmol/kg|MultiHance administered at 0.1 mmol/kg
16112449|NCT02070380|Drug|Dotarem|Dotarem administered at 0.1 mmol/kg
16112450|NCT02070380|Drug|MultiHance 0.05 mmol/kg|MultiHance administered at 0.05 mmol/kg
16112451|NCT02070367|Other|Somatosensory rehabilitation|
16112452|NCT02070367|Other|Usual treatment: physiotherapy|
16112453|NCT02070341|Drug|Polyethylene Glycol|
16112454|NCT02070341|Drug|Picosalax|
16112455|NCT02070328|Other|Registry|
16112456|NCT02070302|Drug|Botulinum Toxin Type A|40 units of BOTOX® (onabotulinumtoxin A) divided into two injection sites of 20 units each
16112457|NCT02070302|Drug|Placebo|Placebo (Normal Saline) divided into 2 injections of .4cc each
16112458|NCT02070289|Drug|PF-06372865|Tablets, 2.5 mg BID, 14 days
16112459|NCT02070289|Drug|Placebo|Tablets, BID, 14 days
16112460|NCT02070289|Drug|PF-06372865|Tablets, to be decided dose, BID or titration, 14 days
16112461|NCT02070289|Drug|Placebo|Tablets, BID or titration, 14 days
16112462|NCT02070289|Drug|PF-06372865|Tablets, to be decided dose, BID or titration, 14 days
16112463|NCT02070289|Drug|Placebo|Tablets, BID or titration, 14 days
16112464|NCT02070289|Drug|PF-06372865|Tablets, to be decided dose, BID or titration, 14 days
16112465|NCT02070289|Drug|Placebo|Tablets, BID or titration, 14 days
16112466|NCT02070289|Drug|PF-06372865|Tablets, to be decided dose, BID or titration, 14 days
16112467|NCT02070289|Drug|Placebo|Tablets, BID or titration, 14 days
16112468|NCT02070289|Drug|PF-06372865|Tablets, to be decided dose, BID or titration, 14 days
16112469|NCT02070276|Procedure|Trans-thoracic echocardiography|Subcostal evaluation of inferior vena cava dimensions and colorability with cyclic spontaneous breathing in order to determine if the patients will be fluid responsive or not.
16112470|NCT02070276|Procedure|Passive Leg Raising Test|Application of this test in a standard manner in order to determine if our spontaneous breathing patients are fluid responsive before spinal anesthesia.
16112471|NCT02070250|Behavioral|From Cancer to Health (C2H-D)|From Cancer to Health gives people with cancer the information and tools they need to manage their stress to improve their health throughout the cancer journey. Each institution involved in this study will implement the core techniques of the C2H-D Intervention but may alter the format somewhat to meet their patient population needs (e.g., shorten hourly 18 week intervention into 2-hour 9 week intervention).
16112472|NCT02070237|Drug|Enoxaparin|Enoxaparin will be given in either once daily or twice daily doses. One arm will receive 40 mg enoxaparin subcutaneous injection daily. The other arm will receive 0.5 mg/kg dosed subcutaneously twice daily. This medication will be started 8-12 hours after cesarean section and will be continued while the patient is admitted. It will be stopped at the time of discharge.
16112473|NCT02070224|Other|Serum and urine samples collections|Serum and urine samples will be collected at baseline, 3 month, 6 month, 12 month to assess the predictive value of cartilage-specific biomarkers Coll2-1/Coll2-1NO2 on OA progression (MRI, Clinical and radiological progression)
16112474|NCT02070224|Other|Imaging (x-rays and MRI)|MRI will be done at baseline and 12 month and x-rays will be done at baseline
16112475|NCT02070211|Dietary Supplement|omega-3 PUFAs|4 capsules (2 in the morning; 2 in the evening) for a period of 12 weeks. The active treatment is a supplement of yellow gelatine 0.625 g capsules containing concentrated marine fish oil. The daily dose of 4 capsules will provide approximately 700 mg of eicosapentaenoic acid (EPA, 20:5n3), 480 mg of docosahexaenoic acid (DHA, 22:6n3), and 7.6 mg of Vitamin E.
16112476|NCT02070211|Other|Standard care|Standard care includes management by a psychiatrist or resident psychiatrist and non-neuroleptic pharmacotherapy as clinically indicated. Specifically, Cognitive-behavioural therapy (CBT) embedded within case management will be administered. The CBT will be based on the models developed at the PACE Clinic in Melbourne, in the EDIE trial, and in Cologne, as these have proven to be effective in RCTs. The number of sessions delivered will be captured for each client. In addition, fidelity will be monitored by therapists rating their own sessions on an established checklist of therapeutic interventions.
16112477|NCT02070211|Dietary Supplement|placebo|4 capsules of 0.7g of paraffin oil (which is not absorbed by the gastrointestinal tract) per day.
16112478|NCT02070198|Drug|Long acting FSH and GnRH antagonist|Woman in long acting FSH and GnRH antagonist arm receive an initial dose of 150 mcg Corifollitropin alfa on second day of the menstrual cycle followed by a fixed daily dose of 0.25 mg of GnRH antagonist on day 7 of the cycle onwards. On the ninth day of the cycle, a daily fixed dose of 300 IU of recombinant FSH will be administered until the day of ovulation triggering.
16112479|NCT02070198|Drug|Daily FSH and GnRH antagonist|Woman in daily FSH and GnRH antagonist arm receive a fixed dose of 300 IU of recombinantFSH starting 3 day of the menstrual cycle followed by a fixed daily dose of 0.25 mg of GnRH antagonist on day 7 of the cycle onwards until the day of ovulation triggering.
16112480|NCT02070198|Drug|Triptorelin and recombinant FSH|Women in Triptorelin and recombinant FSH arm receive a fixed dose of 0.05 mg of Triprorelin from the 1 day of the menstrual cycle followed by a fixed dose of 300 IU of recombinant FSH starting 3 day untill the day of HCG administration.
16112514|NCT02069808|Drug|Ganirelix|GnRH antagonist preventing a problematic risk of premature LH surge during ovulation induction therapy.
16112550|NCT02069522|Other|Standard Milk-based Formula Containing Carotenoid|Fed ad libitum
16112481|NCT02070185|Behavioral|2 exposures arm|"During this study, children were exposed to 2 flavored sweetened beverages: a high energy version (HE: 150kcal) and a no energy version (NE: 0kcal).
~During a 4-wk conditioning period, children were exposed either 2 times to each beverage.
~After a 3-wk stability period without exposure, children were exposed 3 times to both beverages in which the association between the flavor and the energy density had been switched (4-wk extinction period)."
16112482|NCT02070185|Behavioral|7 exposures arm|"During this study, children were exposed to 2 flavored sweetened beverages: a high energy version (HE: 150kcal) and a no energy version (NE: 0kcal).
~During a 4-wk conditioning period, children were exposed either 7 times to each beverage.
~After a 3-wk stability period without exposure, children were exposed 3 times to both beverages in which the association between the flavor and the energy density had been switched (4-wk extinction period)."
16112483|NCT02070159|Drug|Clopidogrel 600 mg|Patients administer 600 mg of clopidogrel as conventional loading dose of clopidogrel
16112484|NCT02070159|Drug|Prasugrel 30 mg|Patients administer 30 mg of prasugrel as lower loading dose of prasugrel.
16112485|NCT02070159|Drug|Prasugrel 60 mg|Patients take 60 mg of prasugrel as conventional loading dose of prasugrel.
16112486|NCT02070133|Drug|Simvastatin|Simvastatin 40 mg once a day during 12 weeks
16112487|NCT02070133|Drug|Placebo|Placebo once a day during 12 weeks
16112488|NCT02070120|Drug|Mitomycin C|Patients assigned to the chemoresection group will receive 4 once weekly intravesical instillations of 40mg MMC as outpatients.
16112489|NCT02070120|Procedure|Surgical Management|Patients in this group should be treated according to local practice. Surgical interventions may include transurethral resection (TUR) or ablation.
16112490|NCT02070107|Other|On Plan|"On Plan is a highly customizable software package developed by our co-investigator at the University of Louisville for a variety of applications related to compliance."
16112491|NCT02070081|Procedure|Roux-en-Y gastric bypass surgery or sleeve surgery|
16112492|NCT02070068|Device|PINPOINT System|
16112493|NCT02070055|Other|No intervention|
16112494|NCT02070042|Drug|Omega 3 Fatty Acid|Trunature® Triple Strength Omega-3, given twice a day. Each capsule contains 647 mg Eicosapentaenoic Acid (EPA) and 253 mg Docosahexaenoic Acid (DHA).
16112495|NCT02070042|Drug|Placebo|Placebo capsules (olive oil) twice a day
16112496|NCT02070029|Procedure|Acupuncture|"Acupuncture Therapy - Initial Evaluation History including: chief complaint, diet, level of diaphoresis, water intake, digestive function, menstrual cycling, sleep habits, overall mood.
~Physical Exam: inspection of tongue and palpation of central and peripheral pulses.
~Chinese Diagnoses for Female Sexual Dysfunction: Kidney Yang Deficiency; Liver Qi Stagnation; Generalized Blood Deficiency; Spleen Yang Deficiency; Heart Fire
~- Subsequent Sessions 25 minute sessions, twice weekly, for 5 weeks = total 10 sessions Needle usage = 8-20, average 14 per session Typically placed on the scalp, lower abdomen, elbows and knees"
16112497|NCT02070016|Device|Transcranial Magnetic Stimulation|
16112498|NCT02070003|Behavioral|Motivational Interviewing and Physician Guided Opioid Weaning|
16112499|NCT02069990|Drug|Cholecalciferol|
16112500|NCT02069977|Drug|Aripiprazole|
16112501|NCT02069951|Other|Practice a procedural module on a simulator|
16112502|NCT02069925|Behavioral|Early Detection (ED)|This intervention consists of educational campaigns directed at patients & families (who have yet to seek care) and professionals in educational and clinical settings to hasten referral of individuals with new onset psychosis to an established, best-practice first-episode service (i.e. STEP). Interleaved with this educational campaign will be procedures to make the STEP clinic more rapidly responsive to referrals to further shorten the duration of untreated psychosis
16112503|NCT02069925|Behavioral|Usual Detection|This intervention will provide equivalent best practice care without the benefit of an early detection campaign
16112504|NCT02069912|Behavioral|Collaborative depression care management|Collaborative depression care management will include acute depression treatment with antidepressant medication and/or counseling sessions based on structured problem solving therapy. Participants will also receive supportive patient navigation services and maintenance/relapse telephone monitoring. Counseling treatment will include 8 weekly 45-minute counseling sessions that are culturally and health literacy adapted for the study population. The length of medication treatment will depend upon participants' severity of depression and may last up to 12 months.
16112505|NCT02069899|Drug|NI-0501|In the event that NI-0501 treatment needs to be prolonged beyond Week 8 foreseen in the previous study, and upon request of the treating physician, patients will continue receiving NI-0501 in the context of this study.
16112506|NCT02069886|Drug|deferasirox|125, 250, 500 mg dispersable tablets
16112507|NCT02069873|Behavioral|16-Week Group Treatment|Within the 16-week group treatment, the cognitive block will contain 5 sessions, the exposure block will contain 5 sessions, and the skills block will contain 4 sessions.
16112508|NCT02069860|Device|Bone Anchored Port System (BAP)|The port body will be implanted onto the petrous bone and a sealing cap, a twofold valve system and a catheter are connected to the port body. The catheter is tunneled under the skin, enters the internal jugular vein and ends in the right atrium of the heart. The novelty of the access lies in its location (retro auricular on petrous bone) and its bone fixation.
16112509|NCT02069847|Drug|Budesonide|"Participants will be instructed to swallow budesonide 3mg twice daily for eight consecutive weeks following endotherapy with EMR or ESD. Budesonide will be provided in a capsule containing 3mg budesonide only by Mayo Clinic Pharmacy with full 8 weeks supply.
~The patient will require opening the capsule and mixing the budesonide powder in 10ml (2 teaspoons) honey, or pancake syrup.
~Patients will be instructed not to ingest any solid or liquids for 30 minutes before and after taking the budesonide. For purposes of this study, budesonide is used off-label but according to the same dose and efficacy as has been demonstrated in other esophageal inflammatory conditions. Patients will receive a handout with exact instructions how and when to take Budesonide."
16112510|NCT02069834|Drug|Arm 1 (intervention)|Dolutegravir 50 mg/j + Rilpivirine 25 mg/j qd orally (intake during meal)
16112511|NCT02069834|Drug|Arm 2 (control)|Continuation of existing HAART at the time of randomization
16112512|NCT02069821|Drug|combination administration|combination administration : amlodipine/valsartan 10/160mg and atorvastatin 40mg, qd, 10days(oral)
16112513|NCT02069808|Drug|Follistim|Follicle stimulating hormone promotes recruitment of follicles for ovulation.
16112549|NCT02069535|Biological|AVANZ Cupressus|AVANZ Cupressus
16112515|NCT02069808|Drug|Menotropins|Combination of follicle stimulating hormone and Luteinizing hormone activity promotes recruitment of follicles for ovulation. Absence or presence of this medication is the difference being tested between the two arms of the study.
16112516|NCT02069808|Drug|Leuprolide|Promotes endogenous LH surge signaling oocyte maturation followed by ovulation. This controls timing for oocyte collection.
16112517|NCT02069808|Procedure|Transvaginal ultrasound guided needle aspiration of oocytes|
16112518|NCT02069795|Other|Voice recording|
16112519|NCT02069782|Other|Home visiting|Home visits are used to assess family needs, provide support and education, and make referrals to relevant community services. The goals of the programs are to improve child health and development, promote positive parenting, prevent child maltreatment, improve maternal and child health, and increasing parental self-sufficiency.
16112520|NCT02069769|Behavioral|communication with oncology team|Oncology team will contact patients and families via telephone at specific intervals
16112521|NCT02069743|Other|ePAL Mobile Application|A mobile application designed to help cancer patients better self-manage cancer pain.
16112522|NCT02069730|Drug|Selinexor|"If no druggable aberrations are identified on the molecular profiling analysis, then patients will receive unmatched treatment with Selinexor, a selective inhibitor of nuclear export (SINE)."
16112523|NCT02069730|Drug|EGFR or HER2 Inhibitor|"If specific druggable aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with EGFR or HER2 Inhibitor"
16112524|NCT02069730|Drug|FGFR Inhibitor|"If specific druggable aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with FGFR Inhibitor"
16112525|NCT02069730|Drug|C-KIT Inhibitor|"If specific druggable aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with C-KIT Inhibitor"
16112526|NCT02069730|Drug|Anti-androgen|"If specific druggable aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with Anti-androgens"
16112527|NCT02069730|Drug|NOTCH Inhibitor|"If specific druggable aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with NOTCH Inhibitor"
16112528|NCT02069730|Drug|MEK or PI3K Inhibitor|"If specific druggable aberrations are identified on the molecular profiling analysis, then patients will receive matched treatment with MEK or PI3K Inhibitor"
16112529|NCT02069717|Other|Not applicable-observational study|
16112530|NCT02069704|Drug|Bevacizumab biosimilar (BEVZ92)|"Active ingredient Bevacizumab 25 mg/mL (strength = 100 mg/4 mL). 30-minute* IV infusion (5 mg/kg) every 2 weeks, prior to chemotherapy (Folfox any or Folfiri).
~FOLFIRI = Folinic Acid + Fluorouracil + Irinotecan FOLFOX = Folinic Acid + Fluorouracil + Oxaliplatin Treatment will continue until disease progression, unacceptable toxicity, patient withdraws consent or death (whichever occurs first).
~*The first infusion will be given over 90 minutes. If it is well tolerated, the second infusion can be given over 60 minutes. If it is well tolerated, subsequent infusions can be given over 30 minutes.
~The FOLFOX (any) or FOLFIRI regimen will be chosen as per investigator's criteria based on the hospital standard of care."
16112531|NCT02069704|Drug|Avastin® (bevacizumab, reference product)|"Active ingredient: Bevacizumab 25 mg/mL (strength: 100 mg/4 mL). 30-minute* IV infusion (5 mg/kg) every 2 weeks, prior to administration of chemotherapy. Treatment will continue until disease progression, unacceptable toxicity, patient withdraws consent or death (whichever occurs first).
~*The first infusion will be given over 90 minutes. If the first infusion is well tolerated, the second infusion can be given over 60 minutes. If this infusion is well tolerated, subsequent infusions can be given over 30 minutes.
~The FOLFOX (any) or FOLFIRI regimen will be chosen as per investigator's criteria based on the hospital standard of care."
16112532|NCT02069691|Device|virtual reality-cycling training system|
16112533|NCT02069665|Other|Fuxiong San|external application; 8-10cm wide, 0.3-0.5cm thick; 10mins for patient aged 1 to 3-year old; 15mins for those aged 3 to 5-year old; once daily
16112534|NCT02069665|Drug|Xiyanping injection|ivd. 5 to 10 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection.
16112535|NCT02069665|Drug|Ribavirin Injection|ivd. 10 to 20 mg/(kg•d), plus 5% Glucose Injection, 80 to 100 ml, ivd. Once a day injection.
16112536|NCT02069665|Drug|Xiaoer Qingfei Heji (mixture)|children aged 6 months to 1 year old: 10 ml, orally taken three times daily; children aged 1 to 3 year old: 15 ml, orally taken three times daily; children aged 3 to 5 year old: 20 ml, orally taken three times daily;
16112537|NCT02069665|Drug|Zhi Ke San|children aged 6 months to 1 year old: 0.5g, orally taken three times daily; children aged 1 to 3 year old: 1.5g, orally taken three times daily; children aged 3 to 5 year old: 2.0g, orally taken three times daily;
16112538|NCT02069665|Drug|Hua Tan San|children aged 6 months to 1 year old: 0.5g, orally taken three times daily; children aged 1 to 3 year old: 1.5g, orally taken three times daily; children aged 3 to 5 year old: 2.0g, orally taken three times daily;
16112539|NCT02069665|Drug|Guaifenesin Syrup|children aged 6 months to 1 year old: 3ml, orally taken three times daily; children aged 1 to 3 year old: 5ml, orally taken three times daily; children aged 3 to 5 year old: 8ml, orally taken three times daily;
16112540|NCT02069665|Drug|Ibuprofen Suspension|taken under prescription
16112541|NCT02069665|Drug|salbutamol|taken under prescription
16112542|NCT02069652|Behavioral|Lifestyle Counseling|Lifestyle Counseling
16112543|NCT02069639|Other|no treatment|
16112544|NCT02069626|Procedure|compression time of the laparoscopic linear stapler|
16112545|NCT02069600|Device|Continuous Positive Airway Pressure|"CPAP applies a positive pressure into the airway to avoid its collapse during sleep.
~The pressure used in each patient is calculate by an auto CPAP device during 3 months. This device calculate the pressure that avoid 95% of sleep-disordered breathing"
16112546|NCT02069587|Dietary Supplement|pomegranate|
16112547|NCT02069574|Procedure|non-surgical periodontal therapy|
16112548|NCT02069561|Dietary Supplement|Eicosapentaenoic Acid|Twenty patients with long-standing ulcerative colitis undergoing the usual colonoscopic surveillance + biopsy sampling will be recruited. At entry six extra biopsy samples will be collected from the colon. We will also collect blood (for serum, plasma and red cells isolation), urine and stools. Subjects will then receive 2 g/day of Eicosapentaenoic Acid (ALFA ™, SLA Pharma AG, Switzerland) as a supplement for 90 days. At the end of the study each subject will undergo sigmoidoscopy for the collection of 6 biopsies. Blood, urine and stools will be obtained prior to the procedure.
16112551|NCT02069522|Other|Investigational Milk-based Formula Containing Carotenoid|Fed ad libitum
16112552|NCT02069496|Biological|Arepanrix®|Injected according to the prescribing information in the locally approved label by the authorities.
16112553|NCT02069483|Behavioral|Motivational Interviewing|Subjects will engage in motivational interviewing in order to generate motivating messages related to quitting smoking.
16112554|NCT02069483|Behavioral|Tailored Feedback|Subjects will self-generate reasons they want to quit smoking during the baseline survey and record these reasons during the in-person activity.
16112555|NCT02069470|Behavioral|Continuing Medical Education|3-hour after work meeting. Multifaceted form. Content: Cancer symptoms positive predictive values, pit falls, reflections on barriers and attitudes towards early cancer diagnosis.
16112556|NCT02069444|Procedure|Macintosh laryngoscope|intubation criterias withMacintosh laryngoscopein pediatric patients
16112557|NCT02069444|Procedure|Truview EVO2 laryngoscope|intubation criterias with Truview EVO2 laryngoscope in pediatric patients
16112558|NCT02069431|Drug|Intranasal Oxytocin spray|Intranasal OT (24 IUs) self-administration will take place twice a day over a 28-day period.
16112559|NCT02069431|Other|Intranasal Placebo spray|placebo (containing all of the inert ingredients except for the oxytocin) self-administration will take place twice a day over a 28-day period.
16112560|NCT02069418|Radiation|18F-FLT-TEP|Patients are going to have two 18F-FLT-TEP : one during the two weeks before the beginning of erlotinib and the second one will occur during the second week after the initiation of erlotinib.
16112561|NCT02069418|Radiation|18F-FDG-TEP|Patients are going to have two 18F-FDG-TEP : one during the two weeks before the beginning of erlotinib and the second one will occur during the second week after the initiation of erlotinib.
16112562|NCT02069405|Other|Relaxation Music|
16112563|NCT02069392|Behavioral|Cognitive remediation training|
16112564|NCT02069392|Drug|Nicotine polacrilex lozenge|Of interest are the effects of nicotine on cognitive remediation training benefits.
16112565|NCT02069379|Drug|Metformin|Women classified as insulin resistant will participate in both a placebo and a metformin treatment arm, each lasting about 16 weeks. Women will be randomized to order of treatment arms.
16112566|NCT02069379|Drug|Placebo|Placebo capsules prepared identically to Metformin capsules
16112567|NCT02069366|Drug|Dronabinol|Dronabinol (7.5mg) is administered only once (approximately 120 min prior to fMRI scanning in Visit 3) by the oral route and is placed in opaque capsules with dextrose filler. Half of the participants in each diagnostic group [HC = 20; PTSD = 20; TEC = 20] will receive dronabinol.
16112568|NCT02069366|Drug|Placebo|Placebo is administered only once (approximately 120 min prior to fMRI scanning in Visit 3) by the oral route and contains only dextrose in opaque capsules. Half of the participants in each diagnostic group [HC = 20; PTSD = 20; TEC = 20] will receive placebo.
16112569|NCT02069353|Device|QFlow 500™ Perfusion Probe (Hemedex, Cambridge, MA)|
16112570|NCT02069353|Device|Spencer Probe Depth Electrode (Ad-Tech Medical, Racine, WI)|
16112571|NCT02069340|Drug|zoledronic acid|Given IV
16112572|NCT02069340|Other|pharmacological study|Correlative studies
16112573|NCT02069314|Dietary Supplement|Whey protein supplementation|subjects are asked to consume a smoothie with whey protein added
16112574|NCT02069314|Dietary Supplement|Carbohydrate (polycose) supplementation|Subjects are asked to consume a beverage with polycose added
16112575|NCT02069301|Behavioral|Integrated Depression/Microfinance Group|LIFE-DM Integrated Depression and Microfinance group, uses behavior activation and problem solving therapy skills to teach patients how to manage mood and reach livelihood goals.
16112576|NCT02069301|Other|Treatment as Usual|National Guideline for antidepressant care
16112577|NCT02069301|Other|Livelihood Support|Livelihood support, including group-based loans to develop small enterprise, personal finance management education, business management skills, vocational training, and rotating-credit savings program.
16112578|NCT02069288|Drug|Fludrocortisone|50 µg of fludrocortisone per os
16112579|NCT02069288|Drug|Placebo|1 tablet of placebo per os
16112580|NCT02069275|Other|Immediate mobilization|Patients are mobilized immediate after coronary angiography and percutaneous coronary intervention via femoral access and closed with Angio-seal closing device. Heparin reverted with Protaminsulphate
16112581|NCT02069275|Other|Two hours bedrest|Patients is following the usual regimen, two hours bedrest after coronary angiography and percutaneous coronary intervention via femoral access and closed with Angio-seal closing device before mobilization. Heparin is reverted with Protaminsulphate
16112582|NCT02069262|Other|rebleeding|Those who developed rebleeding during the observation would be crossed over to the other investigation modality.
16112583|NCT02069249|Behavioral|Healthy Sleep intervention|Healthy Sleep Intervention (HSI)- This online interactive e-learning system will include information for parents on the following topics: (a) establishing appropriate bedtime, including how to assess the sleep needs of their child, how to establish regular bedtime and overall sleep schedule, how to deal with daytime naps; (b) establishing a regular and enjoyable bedtime routine (e.g. bedtime stories); (c) coping with bedtime resistance, setting limits to excessive demands, rewarding appropriate sleep related behaviors; (d) coping with bedtime and nighttime fears, strategies to deal with separation anxieties, fears of darkness, scary imaginative creatures etc; (e) coping with excessive night-wakings and eliminating potential reinforcing consequences; (f) coping with nightmares, night terrors and other parasomnias (e.g., night-walking).
16112584|NCT02069249|Behavioral|Healthy Nutrition intervention|Healthy Nutrition Intervention (HNI)- This online system will include information for parents on the following issues: (a) increasing awareness and making healthy food choices; (b) increasing appeal of healthy food by games, rewards, and child involvement in preparation and cooking; (c) setting rules regarding proper eating environment, family meals and schedules; (d) limiting the presence of unhealthy food and beverage temptations at home; (e) limiting TV and other screen time and increasing physical activities; (f) encouraging parents to be positive role models for all these principles.
16112585|NCT02069236|Other|G6PD Test|All subjects are tested by multiple G6PD tests
16112586|NCT02069223|Procedure|Gastrectomy|
16112587|NCT02069223|Procedure|BPD-DS|
16112588|NCT02069210|Other|Blood transfusion|Intraoperative blood transfusion
16112634|NCT02068794|Biological|Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter|Given IP
16113539|NCT02061670|Biological|Placebo|
16112589|NCT02069197|Other|Ketogenic diet|ketogenic diet will consist of 3:1[fat]:[protein+carbohydrate]weight ratio with 1600 kcal restriction. Diet will last 9 months.
16112590|NCT02069197|Drug|Orlistat|Orlistat 120 mg TID for 9 months; life style intervention with recommended caloric goal of 1600 kcal/day.
16112591|NCT02069197|Other|Standardized diet|Standardized diet treatment for 9 months with recommended caloric goal of 1600kcal/day.
16112592|NCT02069184|Drug|IV Acetaminophen|1gm IV. 1st dose at the cord clamping and 3 more doses given every 6th hourly
16112593|NCT02069184|Other|Saline as placebo|100ml saline IV. 1st dose of 100 ml at cord clamping and 3 more 100ml doses every 6th hourly.
16112594|NCT02069158|Drug|PF-05212384|iv administrartion
16112595|NCT02069158|Drug|Paclitaxel|iv administration
16112596|NCT02069158|Drug|Carboplatin|iv administration
16112597|NCT02069145|Drug|OMP-54F28 with Sorafenib|
16112598|NCT02069132|Drug|Warfarin|warfarin treatment will be determined by treating physicians according to in-hospital guidelines, blindly to genotype assessment.
16112599|NCT02069119|Drug|OPC-108459|
16112600|NCT02069119|Drug|Placebo|
16112601|NCT02069106|Dietary Supplement|Pro-Omega LDL|
16112602|NCT02069106|Other|Placebo|
16112603|NCT02069093|Drug|Dexamethasone based mouthwash|Dexamethasone steroid-based oral solution, comprised of 0.5 milligrams per 5mL of alcohol-free dexamethasone.
16112604|NCT02069093|Drug|Everolimus|Commercially available everolimus 10 mg was prescribed to participants by the Investigator according to local regulations.
16112605|NCT02069093|Drug|Exemestane|Commercially available exemestane 25 mg was prescribed to participants by the Investigator according to local regulations.
16112606|NCT02069080|Drug|64-Cu-plerixafor|"Five subjects with CXCR4-positive tumor sample(s) will be administered an initial intravenous (IV) infusion of 64Cu-plerixafor of up to 8+0.8 mCi (0.48+0.048 rem) not to exceed 5 g of 64Cu-plerixafor at Day 0. These subjects will undergo an initial lowdose CT scan followed by 3 consecutive torso PET scans as soon as practical after the infusion, and 2 additional PET/CT scans at 4 hours +/- 1 hour and 24 hours +/- 2 hours post-infusion. Human dosimetry will be calculated based on these results, and a maximum dose will be used, not to exceed the calculated limit of a total effective dose of 5 rem, or the radiation exposure limit for each organ.
~The remaining subjects with CXCR4-positive (n=15) and CXCR4-negative (n=5) tumor sample(s) will be administered 64Cu-plerixafor at the same or a newly calculated dose and will undergo 1 PET/CT scan between 1 and 4 hours post-infusion."
16112607|NCT02069041|Biological|Ramucirumab|Administered IV.
16112608|NCT02069041|Drug|FOLFOX4|Administered IV.
16112609|NCT02069015|Behavioral|Patient education|Patient education on hypertension delivered through a touchscreen kiosk.
16112610|NCT02069002|Behavioral|Cognitive-Behavioral Therapy (CBT)|
16112611|NCT02069002|Behavioral|Applied relaxation group therapy|
16112612|NCT02069002|Behavioral|Information session (psychoeducation)|
16112613|NCT02068950|Behavioral|Progressive resistance training|A 12-week, supervised, group based, progressive resistance training program involving the major muscle groups of the body will be tested. Details of the program: 12 weeks, 3 sessions per week, 7 exercises (leg press, leg curl, hamstring curl, chest press, lateral pull down, sit-ups and back extensions). In general 2-3 sets of 8-15 repetitions will be performed following a progression plan starting with more repetitions at lower intensity progressing to fewer repetitions at higher intensity during the 12-week period (American College of Sports Medicine Position Stand)
16112614|NCT02068937|Drug|Furosemide and Phone contact|The intervention group is conducted by a nurse in a systematic way during one time per week. If signs and symptoms of congestion, the dose of diuretic ( furosemide ) is revised , nonpharmacological guidelines are provided. According to the algorithm 1KG weight changes are indicative of modifying the diuretic dose , with the addition or reduction 1 tablet a day (1 tablet equivalent to 40 milligrams of furosemide)
16112615|NCT02068937|Drug|Furosemide|This group received just diuretic adjusted (Furosemide 40 milligrams) by the doctor on the baseline.
16112616|NCT02068924|Other|Slow freezing versus vitrification|
16112617|NCT02068911|Device|Monitoring of ETCO2 and PTCO2|Concomitant monitoring of ETCO2 and PTCO2
16112618|NCT02068898|Drug|XS003|
16112619|NCT02068898|Drug|Tasigna|
16112620|NCT02068885|Behavioral|Feeding study|Food provision throughout the study to all 3 dietary arms, with the following phases: 1) Weight loss; 2) Weight maintenance; 3) Ad libitum
16112621|NCT02068872|Procedure|Sleeve Gastrectomy|To assess the safety, tolerability and feasibility of sleeve gastrectomy in the perioperative period following liver transplantation in obese (BMI of > 40 or > 35 kg/m2 in the presence of at least one major obesity related co-morbidities (e.g. type 2 diabetes, hypertension, sleep apnea, heart disease, etc) adult subjects aged 18-75 years of age.
16112622|NCT02068859|Drug|Diclofenac Cream 8%|Subjects will be given instructions to apply the study drug topically 3-4 times daily to the affected knee. Application instructions will also be printed on the tubes of products.
16112623|NCT02068859|Drug|Diclofenac Gel 1%|Subjects will be given instructions to apply the study drug topically 3-4 times daily to the affected knee. Application instructions will also be printed on the tubes of products.
16112624|NCT02068846|Drug|Ciprofloxacin|Over encapsulated Ciprofloxacin 500 mg will be taken twice daily for 28 days.
16112625|NCT02068846|Drug|Placebo|Placebo will over encapsulated to match active treatment, taken twice daily for 28 days.
16112626|NCT02068833|Procedure|Gastrectomy|
16112627|NCT02068833|Procedure|BPD-DS|
16112628|NCT02068820|Device|ISB dye and standard white light imaging|Sentinel lymph node mapping utilizing the da Vinci surgical system and ISB dye with standard white light imaging.
16112629|NCT02068820|Device|ICG dye and FireFly fluorescence imaging|Sentinel lymph node mapping utilizing the da Vinci surgical system with ICG dye and FireFly fluorescence imaging.
16112630|NCT02068807|Dietary Supplement|Lutein drops|After randomisation, the infant received orally a total dose of 0.28 mg of lutein in two doses: within 6 hours after birth and at 36 hours of life
16112631|NCT02068807|Dietary Supplement|Glucose drops|After randomization, newborns received 0.5 mL of 5% glucose solution in two doses: within 6 hours (hrs) after birth and at 36 hrs of life.
16112632|NCT02068794|Other|Laboratory Biomarker Analysis|Correlative studies
16112633|NCT02068794|Procedure|Mesenchymal Stem Cell Transplantation|Given IP
16112636|NCT02068781|Dietary Supplement|High-sodium diet|250 mmol NaCl per 24h
16112637|NCT02068768|Device|Avenue® L Interbody Fusion System (LDR Spine)|PEEK, intervertebral cage for interbody fusion of the lumbar spine
16112638|NCT02068742|Other|battery neuropsychological tests|Application of the scores will be on the day 0 (the day before the surgery), day 2 and day 4 (after the surgery).
16112639|NCT02068703|Behavioral|Sleep Education Presentation|Subjects will receive a 10 minute presentation, aimed at educating on the value of sleep WITHOUT a demonstration of tools to improve sleep.
16112640|NCT02068703|Behavioral|Sleep Tool Demonstration|Subjects will receive a 10 minute presentation, aimed at educating on the value of sleep PLUS a demonstration of tools to improve sleep.
16112641|NCT02068690|Drug|BI 425809 PfOS|BI 425809 PfOS
16112642|NCT02068690|Drug|Placebo|Placebo
16112643|NCT02068690|Drug|Placebo|Placebo
16112644|NCT02068690|Drug|BI 425809 tablet|BI 425809 tablet
16112645|NCT02068690|Drug|BI 425809 PfOS|BI 425809 PfOS
16112646|NCT02068677|Other|Sympathetic response|Sympathetic response will be defined as change in heart rate by >10 bpm and change in BP <10mmHg.
16112647|NCT02068677|Other|no sympathetic response|no Sympathetic response will be defined as change in heart rate by <10 bpm and change in BP <10mmHg.
16112648|NCT02068664|Behavioral|prism adaptation treatment|Prism goggles shift the image one sees toward the left (because the thicker portion of the glass lens is on the right). This will change the perception of where the image is in space, causing the person to adapt. The after-effects of the treatment is what is important. It has been shown to make it easier for people to move in the right space (if have right neglect) or improves ability to complete other functional tasks.
16112649|NCT02068651|Behavioral|Advance care planning programme|It is a multi-faceted programme which includes an educational component with support of multimedia materials, reflection on personal values and a facilitated discussion between patient and family carer over future care. It will be delivered to each pair of participant and family carer on individual basis. By the end of the programme, each participant will have a personal workbook summarising the advance care planning process for record.
16112650|NCT02068638|Procedure|IHE first, CONT second|IHE: intermittent high intensity exercise: integration of 10 s maximal sprints every 10 minutes in a continuous low to moderate intensity exercise of 90 minutes. CONT (occurring after a washout period of 2-8 weeks): continuous moderate intensity exercise of 90 minutes
16112651|NCT02068638|Procedure|CONT first, IHE second|CONT: continuous moderate intensity exercise of 90 minutes. IHE (occurring after a washout period of 2-8 weeks): intermittent high intensity exercise: integration of 10 s maximal sprints every 10 minutes in a continuous low to moderate intensity exercise of 90 minutes
16112652|NCT02068638|Procedure|GLU first, GLU-FRU second|: ingestion of a 6% carbohydrate solution (consisting of 90 g glucose dissolved in 1500 ml tap water) over a continuous moderate exercise of 90 minutes. GLU FRU (occurring after a washout period of 2-8 weeks): ingestion of a 12% carbohydrate solution (consisting of 90 g glucose + 90 g fructose dissolved in 1500 ml tap water) over a continuous moderate exercise of 90 minutes
16112653|NCT02068638|Procedure|GLU-FRU first, GLU second|GLU-FRU : ingestion of a 12% carbohydrate solution (consisting of 90 g glucose + 90 g fructose dissolved in 1500 ml tap water) over a continuous moderate exercise of 90 minutes. GLU (occurring after a washout period of 2-8 weeks): : ingestion of a 6% carbohydrate solution (consisting of 90 g glucose dissolved in 1500 ml tap water) over a continuous moderate exercise of 90 minutes.
16112654|NCT02068625|Drug|Rasagiline|Rasagiline 1mg daily orally for 7 days
16112655|NCT02068625|Drug|Placebo|Oral treatment with placebo for 7 days
16112656|NCT02068612|Behavioral|Moderate Intensity Continuous Training+Interval Training|
16112657|NCT02068612|Behavioral|Low Intensity Continuous Training|
16112658|NCT02068599|Drug|TV-45070|TV-45070 ointment administered twice a day (morning and evening) to target knee. Participants were provided with a laminated instruction sheet including pictures that both described and illustrated how the ointment was to be spread over the entire knee anteriorly, medially, and laterally in a thin layer that fully covered the area. The ointment was gently massaged into the skin.
16112659|NCT02068599|Drug|Placebo|Placebo ointment matching active intervention administered twice a day (morning and evening) to target knee. Participants were provided with a laminated instruction sheet including pictures that both described and illustrated how the ointment was to be spread over the entire knee anteriorly, medially, and laterally in a thin layer that fully covered the area. The ointment was gently massaged into the skin.
16112660|NCT02068586|Drug|Sunitinib|Given PO
16112661|NCT02068586|Drug|Valproic Acid|Given PO
16112662|NCT02068573|Device|Ventilation|The ventilation system is placed outside the house and provides filtered conditioned air to the child's bedroom, through insulated pipes mounted in a window opening. The window opening was built specifically for this purpose in form of a thermo plate replacing the window glass. The unit provides the bedroom with at least 2-3 air changes per hour
16112663|NCT02068573|Device|Placebo Ventilation|The placebo unit (DUPLEX 370) is a completely similar installation to the active ventilation unit, but it only recirculates the air in the room instead of replacing it with fresh conditioned air.
16112664|NCT02068560|Drug|dDAVP infusion|
16112665|NCT02068547|Biological|locally harvested autograft, demineralized bone matrix, and cadaveric allograft|
16112666|NCT02068547|Biological|Bone Marrow Aspirate|
16112667|NCT02068521|Drug|somavaratan|Subcutaneous injection
16112668|NCT02068508|Drug|Pioglitazone|Pioglitazone Tablets
16112669|NCT02068495|Drug|Candesartan cilexetil/Amlodipine besilate|Candesartan cilexetil/Amlodipine besilate tablets
16112670|NCT02068482|Drug|Rifaximin|Rifaximin 200 mg 6 tbs per day per 15 days/ month for 2 months
16112671|NCT02068456|Drug|Roflumilast|
16112672|NCT02068443|Drug|Alogliptin|Alogliptin tablets
16112673|NCT02068443|Drug|Metformin hydrochloride|Metformin hydrochloride tablets
16112674|NCT02068443|Drug|Metformin hydrochloride Placebo|Metformin hydrochloride placebo-matching tablets
16112675|NCT02068430|Drug|Riboflavin 0.1%|After topical anesthesia, 1 drop of Riboﬂavin 0.1% ophthalmic solution will be instilled topically in the eye every 2 minutes for 30 minutes. At the end of the 30 minute riboﬂavin pre-treatment period, the eye will be examined with blue light for the presence of a yellow ﬂare in the anterior chamber.
16113160|NCT02064595|Procedure|External fixator|Treatment with external fixation
16112676|NCT02068430|Other|UV-X™ Illumination System|When the yellow ﬂare in the anterior chamber is conﬁrmed, the eye will be aligned under the UV-X™ light with the treatment plane at a working distance that is 50mm from the UV-X™ beam aperture. The correct aperture setting will be selected for the size of the eye (7.5 , 9.5, or 11 mm), and the eye will be irradiated for 30 minutes, during which time instillation of riboﬂavin will continue (1 drop every 2 minutes). At the end of 30 minutes, the UV light source will automatically switch to the off position. The operator will keep track of irradiation time independently to conﬁrm the actual treatment time.
16112677|NCT02068417|Device|shock waves|extracorporeal shock waves: Verum: 0.1 mJ/mm2 Placebo: placebo stand-off
16112678|NCT02068404|Drug|Nifedipine|
16112679|NCT02068391|Behavioral|Stretching Program|The 'Stretching Program' will teach stretching for the upper and lower limbs, and the trunk, as well as breathing exercises for relaxation. Supervised group activities will be performed once per week (45 minutes) and self-directed stretching will be encouraged 4 days per week and monitored by an activity journal. The intensity of stretching and number of stretches will be progressed every 2 weeks. Heart rate and perceived exertion will be monitored. The program will last 6 months.
16112680|NCT02068391|Behavioral|Exercise Program|The 'Exercise Program' will prescribe specific aerobic exercise to the participants. Supervised group exercise will be performed once per week (60 minutes) and self-directed exercise will be encouraged 4 days per week and monitored by an activity journal. The initial walking prescription will be set at ~1.6 km and an intensity equivalent to the anaerobic threshold and/or 60% of peak oxygen uptake. Progressions will be made every 2 weeks, increasing distance to a maximum of 6.4 km and then increasing to a max intensity of 80% of peak oxygen uptake and/or max duration of 60 minutes. Heart rate and perceived exertion will be monitored. The program will last 6 months.
16112681|NCT02068378|Device|CMPE Optical Sensor Device|Christie Medical Physics & Enginieering visual feedback with optical sensing device.
16112682|NCT02068365|Drug|Pegyinterferon-alfa-2a|Pegyinterferon-alfa-2a 180mcq weekly for 48 weeks
16112683|NCT02068352|Drug|OPA-15406|0.3% or 1% OPA-15406 topical ointment, applied twice daily for 8 weeks
16112684|NCT02068352|Drug|Placebo|
16112685|NCT02068339|Drug|Oltipraz 1 (90mg)|
16112686|NCT02068339|Drug|Placebo|
16112687|NCT02068339|Drug|Oltipraz 2 (120mg)|
16112688|NCT02068326|Behavioral|Mentalization Based Treatment|
16112689|NCT02068326|Behavioral|Treatment As Usual|Treatment As Usual
16112690|NCT02068313|Radiation|Toxicity and outcome measures of IMRT|
16112691|NCT02068287|Drug|Esmolol|After, at least six hours of hemodynamic optimization, patients with an hyper dynamic shock received a conventional management with a continuous infusion of Esmolol titrated to gain a 20% reduction in heart rate. This infusion is maintained for six hours.
16112692|NCT02068261|Behavioral|Computerized Cogmed working memory training|Computerized working memory training with Cogmed QM software. The QM software consists of a set of verbal and visual working memory tasks which is trained for 25-40 minutes each session.
16112693|NCT02068261|Behavioral|Treatment as usual|Treatment as usual can consist of medication, psychotherapy, counseling, and psychological assessment.
16112694|NCT02068248|Dietary Supplement|Soluble Fibre|
16112695|NCT02068235|Drug|Ponesimod 5mg i.v.|
16112696|NCT02068235|Drug|Ponesimod i.v.|Dose and infusion rate will be adjusted according to the results of the pilot phase
16112697|NCT02068235|Drug|Ponesimod 10 mg tablet|
16112698|NCT02068222|Drug|ABT-450/ritonavir (r)|Tablet
16112699|NCT02068222|Drug|ABT-530|Tablet
16112700|NCT02068222|Drug|Ribavirin (RBV)|Tablet
16112701|NCT02068209|Drug|Tramadol|patients will receive Tramadol 50mg orally 1 hour before outpatient hysteroscopy.
16112702|NCT02068209|Drug|Placebo|patients will receive a placebo 1 hour before outpatient hysteroscopy
16112705|NCT02068170|Drug|Haloperidol, azi/clari/erythromycin, levo/moxifloxacin, co-trimoxazole, vori/keto/flu/itraconazole, methadone, tacrolimus, sunitinib|
16112706|NCT02068157|Other|Laboratory Biomarker Analysis|Correlative studies
16112707|NCT02068157|Drug|Photodynamic Therapy|Undergo image-guided I-PDT
16112708|NCT02068157|Drug|Porfimer Sodium|Given IV
16112709|NCT02068144|Dietary Supplement|Cranberry Extract|Participants will drink one 15.2 oz bottle of Cranberry Extract beverage daily for 8 weeks.
16112710|NCT02068144|Other|Placebo|Participants will drink one 15.2oz bottle of placebo beverage daily for 8 weeks.
16112711|NCT02068131|Drug|Novaferon|Recombinant anti-tumor and anti-virus protein for injection, 10μg, im, 3 times per week for first 2 weeks, followed by 20μg,im, 3 times per week after 2 weeks.
16112712|NCT02068131|Drug|Capecitabine|The dose of capecitabine is 1250 mg/m2/dose twice each day, orally, 12 hours apart, for 14 consecutive days, every 21 days (total daily dose = 2500 mg/m2).
16112714|NCT02068105|Drug|ALKS 5461|Sublingual tablet
16112715|NCT02068105|Drug|Placebo|Sublingual tablet
16112716|NCT02068092|Drug|Hydroxytyrosol|
16112717|NCT02068079|Drug|Vemurafenib and Trientine|
16112718|NCT02068053|Drug|[14C] BMS-986020|
16112719|NCT02068040|Dietary Supplement|CocoaVia|CocoaVia contains flavanols found natrually in cocoa beans. Capsules will contain 250mg of flavanol
16112720|NCT02068027|Drug|Clonidine Gel 0.1%|
16112721|NCT02068027|Drug|Placebo|
16112722|NCT02068001|Procedure|Roux-en-Y Gastric Bypass|
16112723|NCT02067988|Device|Holmium-166 microspheres hepatic radioembolization.|Holmium-166 microspheres hepatic radioembolization.
16112724|NCT02067975|Drug|Tryptophan|
16112725|NCT02067975|Drug|Placebo|
16112726|NCT02067962|Biological|Blood sample|Blood sample
16112887|NCT02066727|Drug|Dexmedetomidine|Dexmedetomidine is administrated as an adjuvant of lidocaine at a dose of 1.0 μg/ kg.
16112888|NCT02066727|Drug|Normal Saline|Normal Saline is administrated as an adjuvant of lidocaine.
16112727|NCT02067949|Drug|Simvastatin|single oral tablet 40 mg / day If the patient is able to swallow; the tablet will be given orally. Otherwise, it will be crushed, suspended in water and administered via any existing enteral feeding or gastric drainage tube
16112728|NCT02067936|Drug|Group A propofol + remifentanil|Predicted TOL90% according to Bouillon model
16112729|NCT02067936|Drug|Group B propofol + remifentanil|TOL 90% according to the Bouillon interaction model
16112730|NCT02067936|Drug|Group C propofol + remifentanil|TOL 90% according to the Bouillon interaction model
16112731|NCT02067936|Drug|group D propofol + remifentanil|TOL 90% according to the Bouillon interaction model
16112732|NCT02067910|Drug|Abatacept SC|Weekly subcutaneous administration of 125 mg Abatacept
16112733|NCT02067884|Procedure|dynamic contrast-enhanced ultrasound imaging|Undergo CEUS
16112734|NCT02067884|Procedure|shear wave elastography|Undergo SWE
16112735|NCT02067884|Drug|Definity, (Lipid Microspheres) Intravenous Suspension|Participant will receive contrast agent by intravenous administration
16112736|NCT02067884|Device|Philips Shear Wave Elastography|Equipment used for SWE
16112737|NCT02067871|Other|Laser Therapy|Low-level laser therapy was administered twice a week with a minimum of 48h between sessions over a period of eight weeks.
16112738|NCT02067871|Other|Electrical Stimulation|Neuromuscular electrical stimulation was administered twice a week with a minimum of 48h between sessions over a period of eight weeks and with progressive intensity and volume.
16112739|NCT02067858|Radiation|Stereotactic Radiosurgery|
16112740|NCT02067845|Behavioral|Adapted Many Men, Many Voices (3MV) group level intervention|"The intervention will adapt the Many Men, Many Voices (3MV) group level intervention for MSM to address individual and social determinants of HIV/STI risk and vulnerability. This intervention involves 6 consecutive 2-3 hours sessions conducted at a weekend retreat. We will have 1 retreat in Calgary and 1 retreat in Toronto; each retreat will include 20 persons.
~Based on the 3MV format, a draft template includes: Session 1: Intersectionality; Session 2: STI/HIV Prevention Among WSW and LBQ Women; Session 3: STI/HIV Risk Assessment and Prevention Options; Session 4: Relationship Issues; Session 5: Self-efficacy, Resilient Coping and Capacity for Change; Session 6: Social Support and Problem Solving to Maintain Change.
~Delivery methods include discussion, role-plays and risk-reduction planning."
16112741|NCT02067845|Behavioral|A group-based HIV/STI prevention intervention for women who have sex with women|
16112742|NCT02067819|Device|Active Oral Orthotic Treatment|Active treatment group will receive an occlusal splint adjusted to the appropriate therapeutic height (based on an initial fitting). Participants will be instructed to wear the orthotic 24/7 (or as close as possible) for the duration of the study.
16112743|NCT02067819|Device|Placebo Oral Orthotic Treatment|After two weeks, this treatment group will receive an occlusal splint adjusted to the appropriate therapeutic height (based on an initial fitting). Participants will be instructed to wear the orthotic 24/7 (or as close as possible) for the duration of the study.
16112744|NCT02067806|Drug|2-chloroprocaine hydrochloride, 1%|Study included male and female adult patients undergoing spinal anesthesia with chloroprocaine, when the planned surgical procedure was not expected to exceeded 40 minutes.
16112745|NCT02067793|Drug|NRX-1074 1 mg|Single intravenous administration of 1 mg into arm on Day 0
16112746|NCT02067793|Drug|Placebo|Single intravenous injection into the arm on Day 0
16112747|NCT02067793|Drug|NRX-1074 5 mg|Single intravenous injection of 5 mg into the arm on Day 0
16112748|NCT02067793|Drug|NRX-1074 10 mg|Single intravenous injection of 10 mg into the arm on Day 0
16112749|NCT02067780|Drug|Levofloxacin 500mg|One tablet per day for 7days.
16112750|NCT02067767|Drug|Abacavir/Lamivudine/Dolutegravir|"At Day 1 (D1):
~group 1 will switch their ongoing treatment of ABC/3TC + NVP to ABC/3TC/DTG ;
~group 2 will continue NVP and switch ABC/3TC to ABC/3TC/DTG for 6 days (D-5 to D0), then stop NVP from D1."
16112751|NCT02067741|Drug|CR1447|400 mg, corresponding to two 4 g stick packs applications twice daily
16112752|NCT02067728|Behavioral|FNPA tool|Intervention practice will train to use FNPA screening paired with Brief Action Planning. They will implement this approach during well child visits.
16112753|NCT02067728|Behavioral|Usual Care|Practices not undergoing intervention with FNPA tool will provide usual care to patients during well-child visits.
16112754|NCT02067715|Drug|Tooth bleaching|The bleaching agent will be used in a single-application of 45 minutes.
16112755|NCT02067702|Procedure|Limb Cooling Assessment of ET|The non-pharmacological treatment assessments of limb cooling will take place for the subjects which will include the upper limbs. Both clinical and physiological recordings will be measured for a difference in tremors at three different temperatures. 1)baseline assessment maintaining a normal body temperature (96-98°F). 2) at a temperature of 59°F and 3) at a temperature of 80°F for a period of 10 minutes. The clinical assessments will include the Tremor Rating Scale (TRS), Handwriting Assessment Battery (HAB) and the Functional Dexterity Test (FDT). In addition, the Bagnoli and Trigno EMG systems to record surface EMG signals from muscles and accelerometer readings.
16112756|NCT02067689|Device|Transcranial Direct Current Stimulation|Application of a weak electrical current to the scalp
16112757|NCT02067676|Biological|Capsule-Conjugate Campylobacter Vaccine (CJCV1)|The capsule of Campylobacter jejuni strain 81-176 (CPS81-176) conjugated to the mutated diphtheria toxin cross-reacting material 197 (CRM197) (lyophilized CPS-CRM197 conjugate) (CJCV1)
16112758|NCT02067676|Drug|Alhydrogel®, aluminum hydroxide adjuvant (alum)|
16112759|NCT02067663|Device|Paragard|The IUD will be placed as part of standard clinical care.
16112760|NCT02067663|Drug|Mirena|The IUD will be placed as part of standard clinical care.
16112761|NCT02067624|Other|Thai massage|
16112762|NCT02067611|Drug|X0002|Parallel Assignment
16112763|NCT02067611|Drug|Placebo|Parallel Assignment
16112764|NCT02067598|Other|scapular exercise|
16112765|NCT02067585|Dietary Supplement|Standardized Lipid meals|Standardized Lipid meals: 240 ml of Hormel Great Shake Plus liquid nutritional supplement, 203 Kcal/100mL; 49% calories from fat, mostly unsaturated fatty acids of soy origin; 38% calories from carbohydrates, 13% calories from proteins.
16112766|NCT02067572|Other|Saline mouthwash|
16112767|NCT02067572|Other|Salvia mouthwash|
16112889|NCT02066688|Drug|folic acid|Patients receive oral folic acid 1mg daily for 36 months in the absence of unacceptable toxicity or any other adverse effects.
16112768|NCT02067559|Behavioral|ICU Diary|Creation of an ICU diary: A bound empty journal will be stored at the patient's bedside near the nurse charting area. All family members and ICU staff are invited to write in the ICU diary at any time. Procedure for diary writing will follow previous research (see www.icu-diary.org).
16112769|NCT02067559|Behavioral|Psychoeducation|The psychoeducation brochure will describe procedures in the ICU (sedation, ventilation), and the delirium, hallucinations, and trauma that may result; as well as symptoms of PTSD post-ICU. It will provide instructions for follow-up, information, and emergency care. The brochure will instruct participants to contact their follow-up healthcare provider if they have any questions.
16112770|NCT02067546|Device|Experimental toilet seat|
16112771|NCT02067546|Device|Standard toilet seat|
16112772|NCT02067533|Procedure|soft tissue repair in flexion position|
16112773|NCT02067533|Procedure|soft tissue repair in extension position|
16112774|NCT02067520|Drug|intrathecal hydromorphone (IT hydromorphone)|
16112775|NCT02067507|Behavioral|Tailored education and referral|LACDPH Site: 5-minute tailored educational messages and clinic referral for vaccine plus tailored small media
16112776|NCT02067507|Behavioral|Staff training and patient reminders|AltaMed Health Services Corporation Site: (1) Health care provider training on the importance of HPV vaccination, strategies to appropriately frame the HPV vaccine conversation, and recommended processes and procedures for vaccine delivery; (2) Staff training on the importance of HPV vaccination, strategies to promote uptake of the vaccine, and recommended processes and procedures for vaccine delivery; (3) Patient reminders and provider cues for follow-up doses; and (4) Organizational strategies to improve processes for vaccine delivery, in addition to usual care activities
16112777|NCT02067507|Behavioral|Clinic-level reminder systems|Northeast Valley Health Corporation Site: Three different clinic-level reminder systems, including a mailed letter, automated/robo telephone call, or text message reminder
16112778|NCT02067494|Other|Myofascial Soft Tissue Release|Protocol: Myofascial release on thoracolumbar fascia, Myofascial release on diaphragm, Myofascial release in the psoas fascia, Indirect Myofascial release restrictions in the public area, Myofascial release in lumbo-sacral decompression, Myofascial release on sacrum, and Myofascial release on the lumbar fascia.
16112779|NCT02067494|Other|Kinesio taping treatment|"Two bands in I, with anchor onset in sacrum, on paravertebral muscles. Furthermore a strip will be applies on correction space point of maximum pain."
16112780|NCT02067481|Behavioral|Weight loss intervention|This single-arm pre-post study, that involved one-hourly weekly diet sessions delivered by a dietician and 75-minute bi-weekly Physical Activity (PA) sessions of moderate-to-high intensity led by PA monitors, was offered to overweight and obese BC survivors shortly after treatment. Before and after the intervention, anthropometry, dietary information, Quality of Life (QoL) and cardiorespiratory fitness (CRF) were collected.
16112781|NCT02067468|Device|HPV test|QIAGEN - The Digene HPV test®
16112782|NCT02067468|Procedure|COLPOSCOPY|Colposcopy routine health services
16112783|NCT02067468|Device|cytology|Cytology routine health services
16112784|NCT02067455|Other|adding 2 cardiopulmonary exercise testings : peak oxygen consumption (VO2 max) and stress echocardiography|
16112785|NCT02067442|Drug|oral acetaminophen|1000 milligrams given orally before surgery
16112786|NCT02067442|Drug|intravenous acetaminophen|1000 milligrams of intravenous acetaminophen given before surgery
16112787|NCT02067429|Procedure|Limbal Relaxing Incisions|
16112788|NCT02067429|Device|Toric Intraocular Lens|
16112789|NCT02067416|Drug|Anthracycline based chemotherapy|standard of care neoadjuvant treatment with anthracycline based chemotherapy
16112790|NCT02067416|Drug|taxane-based chemotherapy|neoadjuvant taxane based chemotherapy given as standard of care
16112791|NCT02067403|Other|Pressure-support Eadi optimization|
16112792|NCT02067377|Dietary Supplement|Serum bovine immunoglobulin (SBI) medical food|Serum bovine immunoglobulin (SBI) is an FDA regulated, orally administered prescription medical food intended for the nutritional management of patients who are unable to absorb necessary nutrients as a result of therapeutic or chronic medical problems.
16112793|NCT02067377|Dietary Supplement|Placebo (for serum bovine immunoglobulin)|
16112794|NCT02067364|Device|Fit & Function test|
16112795|NCT02067351|Behavioral|Mindfulness|Meditation, body scan, yoga.
16112796|NCT02067338|Drug|1 mg morphine soak in epidural oxidized cellulose|During posterior lumbar spinal surgery , patients received 1 mg morphine-soaked in epidural oxidized cellulose.
16112797|NCT02067338|Drug|normal saline|During posterior lumbar spinal surgery , patients received NSS -soaked in epidural oxidized cellulose.
16112798|NCT02067325|Other|Thai massage|
16112799|NCT02067312|Other|Thai massage|
16112800|NCT02067299|Drug|JNJ-42847922|Participants will receive suspension of JNJ-42847922 (10 mg, 20 mg, and 40 mg) orally on Day 1 of the appropriate treatment periods.
16112801|NCT02067299|Other|Placebo|Participants will receive placebo orally on Day 1 of the appropriate treatment periods.
16112802|NCT02067273|Device|Transcranial Magnetic Stimulation (TMS)|
16112803|NCT02067260|Device|X5 HairLaser|Treatment consists of three, 10-15 minute, at-home treatments per week (on nonconcurrent days) for 26 weeks.
16112804|NCT02067260|Device|X5 Hair Laser Sham Device|Treatment consists of three, 10-15 minute, at-home treatments per week (on nonconcurrent days) for 26 weeks.
16112805|NCT02067247|Device|BeamMed Speed-of-Sound bone strength test at forearm|BeamMed Speed-of-Sound bone strength test at forearm in addition to the DEXA test
16112806|NCT02067234|Other|Routine Care/Education|Nursing staff will spend time educating the patient and family about therapy involved in medically treating atopic dermatitis. This might include different topical therapy to use as well as how often to apply and when to apply.
16112807|NCT02067234|Behavioral|Psychoeducation/Coping Prevention|In addition to routine care, the psychologist will meet with family to review psychoeducation about the mind-body connection as well as introduce and review different strategies regarding coping with stress, sleep strategies, and behavior strategies.
16112808|NCT02067221|Device|RIRS|"RIRS arm
~Use of flexible ureteroscopy to access and remove renal stones without percutaneous nephrostomy tract"
16112809|NCT02067221|Device|MPCNL|"MPCNL arm
~A new technique that reduced the size of percutaneous tract to make renal stone into small pieces."
16113161|NCT02064595|Procedure|Intramedullary nail|Fracture treated with intramedullary nail
16112810|NCT02067208|Device|wedged insole|Wedged insoles are designed to reduce frontal plane knee joint mechanical loads during gait. Specifically, they can alter the knee adduction moment during gait - a variable associated with progression of knee osteoarthritis. In the experimental arm of this study, participants will undergo biomechanical gait analysis to identify the wedged insole that reduces the moments the most. The two options are medial wedge, where the medial aspect of the foot is elevated relative to the lateral aspect, and the lateral wedge, where the lateral wedge is elevated relative to the medial aspect.
16112811|NCT02067195|Drug|Receiving hydration with a 1 mL/kg bolus of intravenous isotonic saline (0.9% sodium chloride)|No hydration for patients without chronic kidney disease(CrCl<60ml/min),or Receiving hydration with a 1 mL/kg bolus of intravenous isotonic saline (0.9% sodium chloride) after diagnosis of chronic kidney disease until 24 hours after PCI. Hydration rate was reduced to 0.5 mL/kg per hour in patients with New York Heart Association class III or KillipⅡ/Ⅲ.
16112812|NCT02067195|Drug|3 mL/kg.hour bolus of intravenous isotonic saline (0.9% sodium chloride)|Receiving hydration with a 3 mL/kg.hour bolus of intravenous isotonic saline (0.9% sodium chloride) from randomization to the end of the procedure, the measurement of LVEDP was conducted after the procedure, a sliding-scale hydration was employed in the LVEDP-guided hydration arm that was based on LVEDP for 2 hours: 5 ml/kg/hr for LVEDP <13 mmHg, 3 ml/kg/hr for LVEDP 13-18 mmHg, and >1.5 ml/kg/hr for LVEDP >18 mmHg, whereas,0.5 ml/kg/hr for LVEDP >20 mmHg, continue hydration with a 1 mL/kg until 24 hours after procedure. Hydration rate was reduced to 0.5 mL/kg per hour in patients with New York Heart Association class III or KillipⅡ/Ⅲ.
16112813|NCT02067182|Drug|Dabigatran|"Antral pulmonary vein ablation for patients with AF
~left atrial fibrosis/electrical scar assessment by electroanatomical mapping
~followed by 6 months OAC (3 months blanking period + 3 months observation period)
~in case of AF-recurrence in month 4-6: re- pulmonary vein ablation
~followed again by 6 months OAC (3 months blanking period + 3 months observation period)
~AF-free patients as assessed by 72h Holter ECG and symptoms wil be random-izedals to the following two interventional arms:
~Experimental arm (group A): OAC with dabigatran for 12 months
~Control arm (group B): No OAC (no placebo medication) for 12 months - Cerebral MRI at randomisation and 12 months later"
16112814|NCT02067169|Biological|CMV Infection|Routine follow-up (viral load, creatininaemia, neutrophil count, isolation of CMV strains when possible) and biological sample collection for . Resistance testing towards any antiviral available by genotype and phenotype (when an isolate is obtained) when resistance criteria are fulfilled. Plasma collection at treatment initiation, and in case of neutropenia, for antiviral dosage.
16112815|NCT02067156|Drug|G-202|G-202 administered by intravenous infusion (IV, in the vein) on Days 1, 2 and 3 of each 28-day cycle until progression or development of unacceptable toxicity
16112816|NCT02067143|Drug|Prephase PDN + CY|
16112817|NCT02067143|Drug|Cycle 1 Induction|
16112818|NCT02067143|Drug|Cycle 2 Induction / Early consolidation|
16112819|NCT02067143|Drug|Cycle 3 Early consolidation|
16112820|NCT02067143|Drug|Cycle 4 Consolidation|
16112821|NCT02067143|Drug|Cycle 5 Consolidation|
16112822|NCT02067143|Drug|Cycle 6 Consolidation|
16112823|NCT02067143|Drug|Cycle 7 Consolidation|
16112824|NCT02067143|Drug|Cycle 8 Reinduction|
16112825|NCT02067143|Drug|Maintenance|If MRD negative MRD u/k SR
16112826|NCT02067143|Procedure|Allogeneic SCT or Autologous SCT|If MRD positive MRD u/k HR
16112827|NCT02067130|Procedure|Fibroscan|Transient elastography (Fibroscan®) is an affordable and noninvasive tool for measuring liver stiffness as a predictor of liver fibrosis. Since Fibroscan® measures liver's stiffness, its utility is not limited to fibrosis, and has been extended to other conditions that would increase the liver's stiffness, such as amyloidosis (Loustaud-Ratti et al. Amyloid 2011) and perhaps iron overload.
16112828|NCT02067117|Drug|GC FLU® Injection, GC FLU® Pre-filled Syringe Injection|
16112829|NCT02067104|Drug|Vismodegib|Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months.
16112830|NCT02067104|Drug|Placebo|Pulse therapy pattern of 2 months of daily treatment and 2 months of no treatment for 24 months.
16112831|NCT02067091|Device|stent implant in a coronary artery|"Implantation of device called a stent in a coronary artery
~Percutaneous coronary intervention"
16112832|NCT02067078|Drug|Dexamethasone 4 mg + Clonidine 75 microgram + Marcaine 90 mg + Adrenaline 90 microgram|Dexamethasone 4 mg Clonidine 75 microgram Marcaine 90 mg Adrenaline 90 microgram
16112833|NCT02067078|Drug|Dexamethasone 2 mg + Clonidine 37,5 microgram + Marcaine 45 mg + Adrenaline 45 microgram|Dexamethasone 2 mg Clonidine 37,5 microgram Marcaine 45 mg Adrenaline 45 microgram
16112834|NCT02067078|Drug|Ropivacaine + Toradol + Adrenaline|Ropivacaine 300 mg + Toradol 45 mg + Adrenaline 0,75 mg
16112835|NCT02067065|Drug|Non-anesthesiologist propofol sedation|Bolus propofol sedation administered according to non-anesthesiologist propofol sedation guidelines of the European Society of Gastrointestinal Endoscopy
16112836|NCT02067065|Drug|Propofol sedation administered by an anesthesiologist|Propofol sedation by an anesthesiologist
16112837|NCT02067065|Procedure|Colonoscopy|Elective total colonoscopy with or without biopsies, polypectomies or mucosal resection, as clinically indicated
16112838|NCT02067052|Procedure|Surgery, radiotherapy and chemotherapy|Surgery: vulvectomy and lymphadenectomy Radiotherapy: 180 cGy / day per 5 days untill maximum dose 4500 - 5940 cGy Chemotherapy: vulvectomy, lymphadenectomy
16112839|NCT02067052|Procedure|Surgery|Vulvectomy & lymphadenectomy
16112840|NCT02067039|Device|OraQuick in home & Sure Check HIV tests|Provision of OraQuick in home & Sure Check HIV tests
16112841|NCT02067026|Dietary Supplement|Aleurone|
16112842|NCT02067026|Dietary Supplement|Placebo|
16112843|NCT02067013|Drug|Ranibizumab|Subjects in the Ranibizumab arm will receive an injection of drug within 2 weeks prior to their surgery.
16112844|NCT02067013|Other|No Ranibizumab|Subjects in the control arm will NOT receive an injection of drug within 2 weeks prior to their surgery.
16112845|NCT02067000|Behavioral|Obstructive Sleep Apnea|Questionnaire about CPAP perceptions
16112890|NCT02066688|Drug|folic acid calcium vitamin D3|Patients receive oral folic acid 1mg + calcium 1200mg +vitamin D3 250 IU daily for 36 months in the absence of unacceptable toxicity or any other adverse effects .
16112891|NCT02066688|Drug|calcium|calcium 1200mg/d + vitamin D3 250 IU/d daily supplements
16113162|NCT02064582|Drug|Enzalutamide|160mg by mouth each day
16112846|NCT02066987|Behavioral|Implementation intention|"It may be helpful for you to plan when and where you will brush your teeth each day over the next month. Please write below when, where, and after what activity you will brush your teeth (e.g., at 8.00 a.m. and 9.00 p.m. in the bathroom after eating breakfast/dinner). Because you should brush your teeth twice a day, please make two plans.
~If it is _____ (WHEN) at or in _______ (WHERE) before/after ______ (ACTIVITY), then I will brush my teeth! If it is _____ (WHEN) at or in _______ (WHERE) before/after ______ (ACTIVITY), then I will brush my teeth!"
16112847|NCT02066987|Behavioral|Action planning|"It may be helpful for you to plan when and where you will brush your teeth each day over the next month. Please write below when, where, and after what activity you will brush your teeth (e.g., at 8.00 a.m. and 9.00 p.m. in the bathroom after eating breakfast/dinner). Because you should brush your teeth twice a day, please make two plans.
~I will brush my teeth at ___(WHEN) at or in ____(WHERE) before/after ___ (ACTIVITY).
~I will brush my teeth at ___(WHEN) at or in ____(WHERE) before/after ___ (ACTIVITY)."
16112848|NCT02066987|Behavioral|active control group|Participants in the active control group will receive an educational pamphlet containing what it is dental brushing, why it is done, and how it is done.
16112849|NCT02066974|Genetic|hepatoma requiring radiotherapy|hepatoma requiring radiotherapy
16112850|NCT02066948|Other|wt loss|subjects will consume a 750 reduced calorie daily diet based on current ht. wt and age
16112851|NCT02066948|Other|Meal Pattern|Even or skewed distribution of protein for a 16 week period of wt loss.
16112852|NCT02066948|Other|meal pattern|skew or even
16112853|NCT02066948|Dietary Supplement|even|even amount of protein distributed between each meal
16112854|NCT02066948|Dietary Supplement|skew|a skewed amount of protein is distributed between each meal
16112855|NCT02066935|Other|kidney transplant patient|kidney transplanted patients for at least one year
16112856|NCT02066922|Device|Delefilcon A contact lens|Commercially available silicone hydrogel contact lens
16112857|NCT02066922|Device|Narafilcon A contact lens|Commercially available silicone hydrogel contact lens
16112858|NCT02066922|Device|Spectacles|Incremental prescription worn over contact lenses if needed to provide acceptable vision
16112859|NCT02066909|Drug|0.15 mg PF-06649751|Oral dosing of 0.15 mg PF-06649751 extemporaneously-prepared solution given once-daily for 14 days.
16112860|NCT02066909|Drug|0.5 mg PF-06649751|Oral dosing of 0.5 mg PF-06649751 extemporaneously-prepared solution given once-daily for 14 days.
16112861|NCT02066909|Drug|0.5 mg PF-06649751|Oral dosing of tablets up to 0.5 mg PF-06649751 given once-daily for 14 days.
16112862|NCT02066909|Drug|1.5 mg PF-06649751|Oral dosing of tablets up to 1.5 mg PF-06649751 given once-daily for 14 days.
16112863|NCT02066909|Drug|1.5 mg PF-06649751 21 Days|Oral dosing of tablets up to 1.5 mg PF-06649751 given once-daily for 21 days.
16112864|NCT02066909|Drug|3.0 mg PF-06649751|Oral dosing of tablets up to 3.0 mg PF-06649751 given once-daily for 28 days.
16112865|NCT02066909|Drug|5.0 mg PF-06649751|Oral dosing of tablets up to 5.0 mg PF-06649751 given once-daily for 28 days.
16112866|NCT02066909|Drug|8.0 mg PF-06649751|Oral dosing of tablets up to 8.0 mg PF-06649751 given once-daily for 28 days.
16112867|NCT02066909|Drug|1.5 mg PF-06649751 in healthy Japanese subjects|Oral dosing of tablets up to 1.5 mg PF-06649751 given once-daily for 14 days given in healthy Japanese subjects.
16112868|NCT02066896|Device|Lasertherapy|Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide). The laser beam applied bilaterally in non contact mode to each salivary gland area, extra orally to the parotid and submandibular glands and intramurally to the sublingual gland/ 4 Joules/cm2 each point (active group)
16112869|NCT02066896|Device|Sham Lasertherapy|Laser 808 wave length infrared Ga AlAs(gallium-aluminum-arsenide).The device will be applied with the laser pen closed by aluminium foil (placebo group).
16112870|NCT02066870|Drug|Icotinib|Icotinib is administered orally 125 mg three times per day, until disease progression or untolerated toxicity.
16112871|NCT02066870|Drug|Arsenic trioxide|"Arsenic trioxide is administered by intravenous injection with an initial dose of 4mg/m2 per day for day 1 to day 14 every 21 days.
~Three dose levels, 4mg/m2, 6mg/m2 and 8mg/m2 will be evaluated according to predefined dose escalation decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at least 2 patients developed a DLT. There was no further dose escalation when this dose was achieved."
16112872|NCT02066857|Device|Cast made of generic plaster or fiberglass cast material|Patients will randomly receive a generic plaster or fiberglass cast for treatment of non-displaced distal radius fracture.
16112873|NCT02066857|Device|"Generic off the shelf removable splint"|"Patients will be randomized to receive a generic off the shelf removable splint for treatment of a non-displaced distal radius fracture."
16112874|NCT02066844|Drug|Celestone|2cc
16112875|NCT02066844|Drug|Lidocaine|5cc
16112876|NCT02066831|Behavioral|Telemedical coaching|
16112877|NCT02066831|Other|Telemedicine|
16112878|NCT02066818|Drug|Lidocaine/tetracaine patch|
16112879|NCT02066818|Drug|1% lidocaine|
16112880|NCT02066805|Drug|Database assessment of off-label XGEVA use|No intervention is planned during this study as it involves analyses of patient electronic records from Northern Jutland Region and Copenhagen
16112881|NCT02066792|Drug|D-Cycloserine|D-cycloserine is a medication thought to be associated with fear extinction.
16112882|NCT02066792|Drug|Placebo|Sugar pill
16112883|NCT02066792|Behavioral|Cognitive Behavioral Therapy|This will be a 5-session version of a group CBT protocol with 4-6 patients and 2 therapists per group emphasizing repeated exposure practices. Session 1 involves an introduction and orientation to the CBT model. Sessions 2-5 emphasize repeated exposure tasks, which consist of role-play activities to confront fearful situations in a group setting while disputing cognitive distortions (coupled with the fading of safety behaviors). At the conclusion of each exposure session, patients will be encouraged to continue to apply home-practice strategies (such as giving speeches in front of a mirror). Continued practice of the interventions will be considered part of treatment, and patients will be asked to refrain from alternative treatment for four weeks following completion of the last treatment session.
16112884|NCT02066766|Other|No treatment given|Patients will fill out a questionnaire by interview.
16112885|NCT02066753|Procedure|Mild therapeutic hypothermia|Mild therapeutic hypothermia with a target temperature between 32-34°C.
16112886|NCT02066740|Device|EverFlex™ stent with Entrust™ delivery system|
16112892|NCT02066675|Drug|Trabectedin|Each patients will receive intravenous trabectedin (1.5 mg/mq-1.3 mg/mq) over 24 hours every 3 weeks
16112893|NCT02066662|Drug|Rivaroxaban or Marcumar|"Arm A: Rivaroxaban (tablet) for patients with atrial fibrillation: with 20 mg once daily for patients with eGFR > 49 ml per minute and 15 mg rivaroxaban once daily for patients with eGFR of 15 to 49 ml. Rivaroxaban (tablet) for patients with pulmonary embolism : 2x a day 15 mg at day 1-21 and 1x 20 mg from day 22 ongoing;
~Arm B: Adjusted dose coumadin/phenprocoumon (tablet) titrated according to target international normalized ratio (INR) with a target range 2.0 to 3.0."
16112894|NCT02066649|Drug|Carvedilol|Administering carvedilol to patients diagnosed with large varices on endoscopy
16112895|NCT02066649|Procedure|Variceal band ligation|Performing variceal band ligation during endoscopy after diagnosis of large varices on endoscopy
16112896|NCT02066636|Drug|Nivolumab|
16112897|NCT02066623|Device|ABSORB Scaffold|Implantation of a drug-eluting vascular scaffold, which is completely resorbable to improve the blood flow in coronary arteries in the presence of stenosis
16112898|NCT02066610|Other|selenium and sodium selenate supplementation|Parenteral nutrition with selenium and sodium selenate supplementation of infant formula
16112899|NCT02066610|Other|selenium and sodium selenite supplementation|Parenteral nutrition with selenium and sodium selenite supplementation of infant formula
16112900|NCT02066610|Other|Without selenium and sodium selenate supplementation|Parenteral nutrition without selenium and sodium selenate supplementation of infant formula
16112901|NCT02066610|Other|Without selenium and sodium selenite supplementation|Parenteral nutrition without selenium and sodium selenite supplementation of infant formula
16112902|NCT02066597|Device|Thrombectomy|Within 96 hours of enrolment, patients will be treated with a single session of PMT using an AngioJet catheter without adjuvant thrombolysis . Venous access will be obtained at the popliteal vein in all patients with a 5-F sheath through which all subsequent venography procedures will be performed. The AngioJet catheter will then be passed over the guide wire and moved from proximal to distal to remove thrombus. Completion venography will be performed through the sheath in all patients. After the completion of the procedure patients are expected to remain in hospital for no more than six hours (1 hour in post-anaesthesia care unit followed by transfer to the surgical daycare unit from where they will be discharged).
16112903|NCT02066584|Other|Sibling oocyte incubation|
16112904|NCT02066571|Drug|Droxidopa|Droxidopa will be supplied in 100 and 200 mg pill sizes. The proposed dosing is 100mg twice daily at baseline, then titrate to 200 mg twice daily at day 7 and then titrate to 300mg twice daily at day 14. Subjects will stay on the 600mg daily for 2 weeks. Total exposure 28 days of study drug.
16112905|NCT02066571|Drug|sugar pill|Sugar pill or placebo will be supplied in pill sizes matched to droxidopa formulation. The study titration will be the same. Sugar pills will be used for 5 weeks during the study.
16112906|NCT02066558|Other|Carbon monoxide|carbon monoxide, 4.7, Purity 99.997, inhalation of carbon monoxide in a volume corresponding to carboxyhemoglobin 10 and 20%, calculated from baseline Hg and body mass.
16112907|NCT02066558|Other|Placebo|
16112908|NCT02066545|Drug|CLS001 Topical Gel|
16112909|NCT02066545|Drug|CLS001 Topical Gel Vehicle|
16112910|NCT02066532|Drug|Ruxolitinib|25 mg bid, 20 mg bid, 15 mg bid, or 10 mg bid, (oral, twice a day) on days 1 through 21 of each 21 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
16112911|NCT02066532|Drug|Trastuzumab|6 mg/kg every 3 weeks (cycle = 21 days). If no trastuzumab > 28 days, patients will be initially re-loaded at 8 mg/kg, then 6 mg/kg.
16112912|NCT02066519|Behavioral|Physical exercise programme using a rowing machine|3 sessions per week of individualized physical training using a rowing machine during 3 months.
16112913|NCT02066506|Other|asymptomatic group|2 visits with MRI
16112914|NCT02066506|Other|symptomatic group|2 visits with MRI
16112915|NCT02066467|Device|Left Ventricular lead implant: ACUITY X4® Lead Family|Implantation of (cardiac re-synchronization therapy with defibrillator) CRT-D devices for heartfailure treatment
16112916|NCT02066454|Drug|Apixaban|2.5mg x 2 per day during 6 months
16112917|NCT02066441|Dietary Supplement|Bio-D-Mulsion Forte®|According to the company's literature, Bio-D-Mulsion Forte® contains: vitamin D (as cholecalciferol), a water and gum Arabic emulsifier base, and sesame oil. This product is documented online at the following web address: http://www.bioticsresearch.com/node/1570
16112918|NCT02066441|Other|Placebo|
16112919|NCT02066428|Biological|AERAS-404|AERAS 404 (H4:IC31) contains a fusion protein of 2 mycobacterial antigens (Ag85B and TB 10.4) formulated in IC31 adjuvant.
16112920|NCT02066428|Biological|Placebo|Tris buffer saline consisting (10mM Tris and 169mM NaCI at pH7.4)
16112921|NCT02066415|Biological|Erenumab|Administered once a month subcutaneously by authorized investigational site study staff.
16112922|NCT02066415|Drug|Placebo|Administered once a month subcutaneously by authorized investigational site study staff.
16112923|NCT02066402|Drug|Tedizolid (BAY119-2631)|50 % of the participants will be randomized to this arm and will receive 200 mg Tedizolid once daily i.v to oral from 1-6 days
16112924|NCT02066402|Drug|Placebo Tedizolid (BAY119-2631)|50 % of the participants will be randomized to this arm and will receive 200 mg Placebo Tedizolid once daily i.v to oral from 7-10 days
16112925|NCT02066402|Drug|Linezolid|50 % of the participants will be randomized to this arm and will receive 600 mg Linezolid twice daily i.v. to oral from 1-10 days
16112926|NCT02066402|Drug|Placebo Linezolid|50 % of the participants will be randomized to this arm and will receive 600 mg Placebo Linezolid twice daily i.v. to oral from 1-10 days
16112927|NCT02066389|Drug|Placebo|Tablets for oral administration
16112928|NCT02066389|Drug|Upadacitinib|Tablets for oral administration
16112929|NCT02066363|Dietary Supplement|Dietician advise|Dietician advise 5 times, during 24weeks. Prescription of a diet plan if wanted from the patient.
16112930|NCT02066363|Dietary Supplement|Parenteral nutrition|Supportive parenteral nutrition.
16112931|NCT02066350|Procedure|Single pancreas transplantation|
16112932|NCT02066337|Procedure|scaling and root planing|
16112933|NCT02066337|Drug|placebo gel|
16112934|NCT02066337|Drug|Ozonated olive oil gel|
16112935|NCT02066311|Drug|Nelfinavir|
16112936|NCT02066298|Drug|Mometasone 220mcg BID|Mometasone is an ICS
16112937|NCT02066298|Drug|Tiotropium Respimat 5mcg QD|Tiotropium is a LMA
16112939|NCT02066285|Drug|Pazopanib|Treatment will continue until disease progression, development of unacceptable toxicity, non-compliance, withdrawal of consent by the patient or investigator decision.
16112940|NCT02066246|Device|AirSeal|100 patients are treated with the AirSeal insufflation and trocar system
16112941|NCT02066246|Device|Olympus UHI-3|100 patients are treated with a conventional insufflation and trocar system
16112942|NCT02066233|Device|EG Scan II (transnasal endoscopy)|
16112943|NCT02066233|Procedure|Standard Endoscopy|
16112944|NCT02066220|Radiation|Radiotherapy without Carboplatin|"Brain - 23.40 Gy in 13 daily fractions of 1.80 Gy Spine - 23.40 Gy in 13 daily fractions of 1.80 Gy Primary tumour boost - 30.60 Gy in 17 daily fractions of 1.80 Gy Total dose - 54 Gy Duration of radiotherapy 6 weeks
~LR Arm after Amendment (Protocol version 11- 17 Nov 2014):
~Brain - 18.0 Gy in 10 daily fractions of 1.80 Gy Spine - 18.0 Gy in 10 daily fractions of 1.80 Gy Primary tumour boost - 36.0 Gy in 20 daily fractions of 1.80 Gy Total dose - 54 Gy Duration of radiotherapy 6 weeks"
16112945|NCT02066220|Drug|Reduced-intensity maintenance chemotherapy|"Starts 6 weeks after radiotherapy. 6 cycles alternating Regimen A and Regimen B. Regimen A (cycles 1, 3, 5): cisplatin 70 mg/m2 day 1, CCNU 75 mg/m2 day 1, vincristine 1.5 mg/m2 days 1, 8 and 15, Regimen B: (cycles 2, 4, 6): cyclophosphamide 1 x 1000 mg/m2 days 1-2, vincristine 1.5 mg/m2 day 1.
~Interval after cycle A: 6 weeks, after cycle B: 3 weeks, for a total duration of 27 weeks.
~Cumulative doses of chemotherapy drugs: cisplatin 210 mg/m2, lomustine (CCNU) 225 mg/m2, vincristine 18 mg/m2, cyclophosphamide 6 g/m2."
16112946|NCT02066220|Radiation|Radiotherapy with Carboplatin|Brain - 23.40 Gy in 13 daily fractions of 1.80 Gy Spine - 23.40 Gy in 13 daily fractions of 1.80 Gy Primary tumour boost - 30.60 Gy in 17 daily fractions of 1.80 Gy Total dose - 54 G Carboplatin 35 mg/m2 5 times/week.
16112947|NCT02066220|Drug|Maintenance chemotherapy|"Starts 6 weeks after radiotherapy. 8 cycles alternating Regimen A and Regimen B. Regimen A (cycles 1, 3, 5, 7): cisplatin 70 mg/m2 day 1, CCNU 75 mg/m2 day 1, vincristine 1.5 mg/m2 days 1, 8 and 15 Regimen B: (cycles 2, 4, 6, 8): cyclophosphamide 1 x 1000 mg/m2 days 1-2, vincristine 1.5 mg/m2 day 1.
~Interval after cycle A: 6 weeks, after cycle B: 3 weeks. Duration 36 weeks. Cumulative doses of chemotherapy drugs: cisplatin 280 mg/m2, lomustine (CCNU) 300 mg/m2, vincristine 24 mg/m2, cyclophosphamide 8 g/m2, carboplatin 1050 mg/m2 (in randomized patients)."
16112948|NCT02066207|Drug|Fenofibrate|
16112949|NCT02066207|Drug|Atorvastatin|
16112950|NCT02066194|Procedure|Electroacupuncture|
16112951|NCT02066181|Other|Laboratory Biomarker Analysis|Optional correlative studies
16112952|NCT02066181|Other|Placebo Administration|Given PO
16112953|NCT02066181|Other|Quality-of-Life Assessment|Optional ancillary studies
16112954|NCT02066181|Drug|Sorafenib Tosylate|Given PO
16112955|NCT02066155|Behavioral|Parish nurse|On-going support following diabetes self-management education provided by Parish Nurse
16112956|NCT02066155|Behavioral|Peer Support|On-going support following diabetes self-management education provided by a trained person with diabetes
16112957|NCT02066142|Device|3D mammography (Tomosynthesis)|Tomosynthesis will be used as normally employed in clinical practice
16112958|NCT02066142|Device|Ultrasound|
16112959|NCT02066129|Drug|Fluticasone 44 mcg|Fluticasone is an inhaled corticosteroid
16112960|NCT02066129|Drug|Fluticasone 220 mcg|Fluticasone is an inhaled corticosteroid
16112961|NCT02066116|Procedure|Kinect-based rehabilitation plus occupational therapy|The developed kinect-based rehabilitation system will be used for 30min/session. Conventional 30min occupational therapy also will be applied for the patient enrolled.
16112962|NCT02066116|Other|sham virtual rehabilitation education plus occupational therapy|For the sham virtual rehabilitation, computer-based cognitive rehabilitation program will be used. Patients will be encouraged to use their affected arm to push the button but the motion will be minimal and not related to the concept of upper extremity rehabilitation.
16112963|NCT02066103|Drug|Paclitaxel|
16112964|NCT02066090|Device|Real acupuncture|"manual acupuncture (bilateral LI4, LI11, SP6, ST25, ST28, ST36) + electroacupuncture (middle CV6, CV12), twice a week, for 6 weeks
~common approaches for the treatment of obesity used by doctors of Korean medicine in Korea today"
16112965|NCT02066090|Device|Sham acupuncture|"sham acupuncture (bilateral LI4, LI11, SP6, ST25, ST28, ST36) + placebo acupuncture without electrical stimulation (middle CV6, CV12), twice a week, for 6 weeks
~sham acupuncture (0.25mm diameter x 40mm length, stainless steel, Acuprime, UK) as control for manual acupuncture (0.25mm diameter x 40mm length, stainless steel, Dongbangacupuncture Inc., Korea)
~placebo acupuncture without electrical stimulation as control for electroacupuncture (0.25mm diameter x 90mm length, stainless steel, Dongbangacupuncture Inc., Korea)"
16112966|NCT02066077|Drug|Etomidate|
16112967|NCT02066077|Drug|Propofol|
16112968|NCT02066077|Device|Bilateral temporal MECT|
16112969|NCT02066077|Device|The right temporal MECT|
16112970|NCT02066077|Device|Bilateral frontal MECT|
16112971|NCT02066064|Procedure|Standard Colonoscopy|Standard Colonoscopy
16112972|NCT02066064|Procedure|G-EYE(TM) Colonoscopy|G-EYE(TM) Colonoscopy
16112973|NCT02066051|Device|IPL|Intense Pulsed Light (IPL) treatment from Quadra Q4 Platinum Series, made by DermaMed Solutions. With the eyes patched closed the IPL was applied to the surface of the skin by the way of a hand-held wand in 30 spots over the skin in the lower lid, cheek area, and nose area starting and ending from in front of each ear.
16112974|NCT02066051|Procedure|Meibomian Gland Expression|After the IPL was applied, the eyes were numbed for 15 minutes with a numbing drop, and a sterile cotton swab was used to squeeze the eyelids and express clogged oil secretions from the miebomian glands.
16112975|NCT02066038|Drug|Erlotinib|150mg po on days 2-15 of each 3 week cycle for 4 cycles and 150mg po per day after 4 cycles until disease progression
16112976|NCT02066012|Other|dysmetabolic iron overload syndrome|
16112977|NCT02065986|Drug|Truvada (once daily tablet containing 300mg tenofovir disoproxil (TDF) and 200mg of emtricitabine (FTC)|
16112978|NCT02065973|Biological|R-enantiomer of 1,2-dioleoyl-3-trimethylammonium-propane chloride + Peptides from HPV-16 E6 and E7|
16112979|NCT02065960|Radiation|Stereotactic body radiotherapy (SBRT)|
16112980|NCT02065947|Procedure|paravertebral block|catheter with 3-level-injection
16112981|NCT02065947|Drug|fentanyl, propofol, atracurium|endotracheal intubation
16113158|NCT02064621|Drug|Candesartan 32mg/Amlodipine 10mg|Candesartan 32mg 1T, PO, QD for 9days/Amlodipine 10mg 1T, PO, QD for 9days
16112982|NCT02065947|Drug|lidocaine , adrenaline, ketamine bolus, midazolam|a mixture of 10 ml bupivacaine 0.5% plus 20 ml lidocaine 2% with adrenaline 1:200,000, ketamine bolus 0.5 mg/kg, midazolam 2-3 mg and continuous propofol using target-controlled infusion (TCI) system aiming at effect site concentration (Ce) of 1-1.5 mcg/mL
16112983|NCT02065947|Device|catheter with 3-level-injection|
16112984|NCT02065947|Drug|sevoflurane and 50% oxygen in air|
16112985|NCT02065934|Other|cardio-pulmonary resuscitation|
16112986|NCT02065895|Device|HIGH error|Overnight and breakfast closed-loop control were performed using a target glucose of 120 mg/dL but with the glucose-value-used-for-control equal to 1.33 times the true glucose value (analogous to higher gain lower target).
16112987|NCT02065895|Device|NO error|Overnight and breakfast closed-loop control were performed using a target glucose of 120 mg/dL and glucose-value-used-for-control equal to the true glucose value.
16112988|NCT02065895|Device|LOW error|Overnight and breakfast closed-loop control were performed using a target glucose of 120 mg/dL but with the glucose-value-used-for-control equal to 0.8 times the true glucose value (analogous to lower gain higher target).
16112989|NCT02065882|Biological|BT524 (fibrinogen concentrate from human plasma)|single intravenous infusion
16112990|NCT02065869|Biological|BPX-501 T cells|1x10E6 cells/kg infused on Day 0
16112991|NCT02065869|Drug|rimiducid|0.4mg/kg administered IV to treat GVHD
16112992|NCT02065856|Biological|AVANZ Salsola|AVANZ Salsola
16112993|NCT02065843|Drug|Mulungu|500 mg/single dose/1 hour before dental surgery
16112994|NCT02065843|Drug|Placebo|500 mg/single dose/1 hour before dental surgery
16112995|NCT02065843|Drug|Passiflora incarnata|100 mg/single dose/1 hour before dental surgery
16112996|NCT02065843|Drug|midazolam|15 mg/single dose/1 hour before dental surgery
16112997|NCT02065830|Device|EKSO|"The subjects will undergo inpatient rehabilitation consisting of a treatment cycle of 30/40 training section using the robot EKSO system device, according to individually tailored exercise scheduling.
~The practice will include robot-assisted walking at variable speeds for 45/60 min and balance training."
16112998|NCT02065817|Other|stable isotope of cholesterol|
16112999|NCT02065804|Drug|Bupivacaine|injection, once, 5 min
16113000|NCT02065791|Drug|Canagliflozin|One 100 mg over-encapsulated tablet orally once daily
16113001|NCT02065791|Drug|Placebo|One matching placebo capsule orally (by mouth) once daily
16113002|NCT02065778|Biological|Autologous bone marrow mononuclear cell transplantation|bone marrow derived mononuclear cells are administered intrathecally in chronic stroke patients
16113004|NCT02065752|Drug|Canagliflozin, 100 mg|Each tablet contains canagliflozin (CANA) of 100 mg to be taken orally (by mouth).
16113005|NCT02065752|Drug|Metformin XR, 500 mg|Each tablet contains metformin extended release (MET XR), 500 mg, to be taken orally (by mouth).
16113006|NCT02065752|Drug|CANA/MET XR FDC, Formulation 1, 50 mg/500 mg|Each tablet contains 50 mg of canagliflozin and 500 mg of metformin HCl granulate, formulation 1, in release-controlling polymers to obtain the XR granulation, to be taken orally.
16113007|NCT02065752|Drug|CANA/MET XR FDC, Formulation 2, 50 mg/500 mg|Each tablet contains 50 mg of canagliflozin and 500 mg of metformin HCl granulate, formulation 2, in release-controlling polymers to obtain the XR granulation, to be taken orally.
16113008|NCT02065739|Drug|JNJ-42165279|Participants will receive a single 30-mg (6 mL of oral suspension) dose of JNJ-42165279 orally (by mouth) on Day 1 (Period 1) and on Day 8 (Period 2).
16113009|NCT02065739|Drug|Itraconazole|Participants will receive itraconazole 200 mg (2 capsules) once a day orally on Days 4, 5, 6, 7, 8, 9, and 10 (Period 2).
16113010|NCT02065726|Dietary Supplement|Whey protein|Nutritional counseling consists in a personalized dietary prescription and regular (monthly) dietetic advise by a registered dietician + 20 g (2 x 10 g) of whey proteins
16113011|NCT02065726|Other|Nutritional counseling|Nutritional counseling consists in a personalized dietary prescription and regular (monthly) dietetic advise by a registered dietician
16113012|NCT02065713|Drug|Golimumab|Prefilled syringe with golimumab 50mg (Simponi®) administrated subcutaneously, once monthly, for 24 weeks.
16113013|NCT02065713|Drug|Methotrexate|MTX started at 15mg/weekly at baseline, increased to 20mg/weekly at week 4 and to 25mg/weekly at week 8, maintaining the dose of 25mg/weekly throughout the trial period of 24 weeks, except in case of intolerance or toxicity
16113014|NCT02065713|Drug|Placebo|The prefilled syringe with placebo will be administrated subcutaneously, once monthly, for 24 weeks.
16113015|NCT02065700|Drug|Filgotinib|Tablets administered orally
16113016|NCT02065687|Drug|Carboplatin|Given IV
16113017|NCT02065687|Other|Laboratory Biomarker Analysis|Correlative studies
16113018|NCT02065687|Drug|Metformin Hydrochloride|Given PO
16113019|NCT02065687|Drug|Paclitaxel|Given IV
16113020|NCT02065687|Other|Placebo Administration|Given PO
16113021|NCT02065687|Other|Quality-of-Life Assessment|Ancillary studies
16113022|NCT02065687|Other|Questionnaire Administration|Ancillary studies
16113023|NCT02065674|Drug|Abroma Augusta Q (mother tincture)|30 drops in 1 cup of water three times a day for 3 months
16113024|NCT02065635|Procedure|maintenance with sevoflurane|in patients allocated to the sevoflurane group, general anesthesia will be maintained with sevoflurane
16113025|NCT02065635|Procedure|maintenance with propofol|in patients allocated to the propofol group, general anesthesia will be maintained with propofol
16113026|NCT02065622|Drug|Adalimumab|
16113027|NCT02065622|Other|Placebo|
16113028|NCT02065609|Drug|89Zr-Trastuzumab Human Dosimetry and Safety|PET Imaging following administration of 89Zr labeled Trastuzumab for calculation of human dosimetry and overall safety
16113029|NCT02065609|Drug|HER2 Positive Lesion Detection and Safety|Detection of HER2 Positive Breast Cancer with 89Zr Labeled Trastuzumab and PET imaging
16113030|NCT02065596|Drug|Fludarabine|the study will begin with enrollment of an initial safety cohort of at least 10 subjects at the lowest dose, after which enrollment will pause until the dose-limiting toxicity (DLT) period has been completed. If a patient experiences DLT, defined as failure to engraft. In which case, the patient may be advanced to two higher doses.
16113075|NCT02065336|Drug|chlorpheniramine|In all cohorts, each participant received an 8 mg dose of oral chlorpheniramine 2 hours prior to each administration of ARC-520 Injection.
16113031|NCT02065596|Procedure|Hematopoietic Stem Cell Transplant (HSCT)|Three weeks after Immunomodulation patients will be infused with matched bone marrow from a sibling, unrelated donor, haploidentical donor, or cord blood. Patients will be followed for the following year.
16113032|NCT02065570|Drug|Adalimumab|
16113033|NCT02065570|Drug|Placebo|
16113034|NCT02065557|Biological|Adalimumab|Subcutaneous (SC) injection
16113035|NCT02065557|Biological|Placebo|Subcutaneous (SC) injection
16113036|NCT02065544|Behavioral|behavioral weight loss and exercise|Weight loss and exercise counseling
16113037|NCT02065531|Other|Myofascial Soft Tissue Release|Protocol: Transverse Plane-Level Clavicular Release. Diaphragmatic Transverse Plane Release. Square the Lumbar Fascia Release. Gluteal Fascia Release. Hint Of Pubic Region Release. Fascia Psoas Release. Lumbo-sacral Decompression. Pelvic Floor Release.
16113038|NCT02065531|Other|Mobilization with impulse technique.|Subject in lateral decubitus with extension and lower limb traction contact the couch with contralateral lower limb was performed triple flexion and left trunk rotation. This technique reduces the slack (tension joints) of the ventral pelvis, head and into the contralateral side of the sacrum support (base) with the forearm.
16113039|NCT02065518|Device|NMES|Participants will train at 15-20% of maximal voluntary contraction (MVC) during weeks 1-3, 21-30% of MVC during weeks 3-6 and 31-40% of MVC during weeks 6-9, 41-50% of MVC during weeks 9-12, then sustain 50% of MVC during weeks 12-18. Incremental increases will be made at the 3, 6, 9, and 12-week clinic visits.
16113040|NCT02065518|Behavioral|Strength Walking|Strength Walking participants will maintain a daily training log. Pedometer readings will form the basis for setting activity goals. Initial step goals will be 10% above the average 3-day pedometer step count taken at baseline, with a 10% increase every other week, and then a gradual increase when 30% above the baseline step count has been achieved. At week 7, participants will be given a weighted vest to begin the strengthening component. Participants will be instructed to wear the vest during their 30-minute walk, 3 to 4 days a week. The beginning weight load for the vest will be calculated using 2% of baseline body weight and it will be increased by that same amount every week thereafter until the end of the 12 weeks.
16113041|NCT02065518|Behavioral|Standard Rehabilitation Protocol|All participants will receive the current standard of care at the 2 military sites (Walter Reed National Military Medical Center (WRNMMC) and Malcolm Grow Medical Clinics and Surgery Center (MGMCSC)) of the physical therapy rehabilitation protocol for knee injuries. This program includes treatment with a physical therapist at WRNMMC and MGMCSC physical therapy clinic.
16113042|NCT02065505|Other|Mat Pilates|
16113043|NCT02065505|Other|Water Pilates|
16113044|NCT02065492|Drug|Standard Chelation|This will comprise of standard chelation drugs (Deferasirox or Deferoxamine or Combination of Deferoxamine and Deferiprone).The dosage and drug used will depend on ferritin levels and individual requirement, as determined by the treating hematologist and will be in accordance with the Iron chelation guidelines from Pakistan Thalassemia Society.
16113045|NCT02065492|Drug|Amlodipine|doses of 0.2 to 0.25 mg/kg/day PO would be given during this trial
16113046|NCT02065479|Drug|Prasugrel|Comparison of platelet reactivity between prasugrel and ticagrelor
16113047|NCT02065479|Drug|Ticagrelor|Comparison of platelet reactivity between prasugrel and ticagrelor
16113048|NCT02065466|Drug|nab-paclitaxel|
16113049|NCT02065466|Drug|Temozolomide|
16113050|NCT02065466|Drug|Bevacizumab|
16113051|NCT02065453|Device|disposable device (Ligasure, Covidien)|"One side of the uterine attachments would be transected using the disposable device (Ligasure, Covidien). . We will randomize the side for each energy source used on each side for every case. The number of sides performed by the attending surgeon will equal that of the less experienced resident surgeon."
16113052|NCT02065453|Device|Reusable device|One side of the uterine attachments would be transected using the reusable Robi bipolar and Storz laparoscopic
16113053|NCT02065440|Drug|Rhinoebastel|Rhinoebastel(ebastine 10mg/pseudoephedrine 120mg) 1 cap/day for 1 week unless progression or unacceptable toxicity develops.
16113054|NCT02065440|Drug|Placebo|Placebo 1 cap/day for 1 week unless progression or unacceptable toxicity develops
16113055|NCT02065427|Behavioral|Social Support|a) PHCT professionals: standardized training to implement caregivers intervention. b) Caregivers: 1 individualized counselling session, 1 family session, and 4 educational group sessions conducted by participating PHCT professionals; in addition to usual home health care visits, periodic telephone follow-up contact and unlimited telephone support.
16113056|NCT02065414|Other|Listerine Advance Gum Defense|
16113057|NCT02065414|Other|Mouth rinse containing Chlorhexidine|
16113058|NCT02065414|Other|Mouth rinse containing 5% Hydroalcohol|
16113059|NCT02065401|Drug|Deferitazole (disodium salt, granule)|Single oral dose of 1500 mg administered on Day 1
16113060|NCT02065401|Drug|Deferitazole (disodium salt, tablet)|Single oral dose of 1500 mg administered on Day 1
16113061|NCT02065401|Drug|Deferitazole (magnesium hydroxide salt)|Single oral dose of 2400 mg administered on Day 1
16113062|NCT02065388|Behavioral|Standard of care dosing for warfarin|
16113063|NCT02065388|Genetic|Genotype-guided dosingTaiwan algorithm for warfarin|
16113064|NCT02065388|Genetic|Genotype-guided dosing IWPC algorithm for warfarin|
16113065|NCT02065375|Drug|RTA 408 0.5% Ophthalmic Suspension|
16113066|NCT02065375|Drug|RTA 408 1.0% Ophthalmic Suspension|
16113067|NCT02065375|Drug|Placebo|
16113068|NCT02065362|Biological|DNR.NPC-specific T cells|"Each patient will receive 2 infusions, 14 days apart, according to the following dosing schedule:
~Dose Level 1:
~Day 0: 2 x 10^7 cells/m^2
~Day 14: 2 x 10^7 cells/m^2
~The doses are calculated according to the total T cell number."
16113069|NCT02065362|Biological|DNR.NPC-specific T cells + cyclophosphamide + fludarabine|"Patients will receive cyclophosphamide and fludarabine for 3 days before receiving the DNR.NPC-specific T cells.
~Each patient will receive infusions according to the following dosing schedule:
~Dose Level 2:
~Cy/Flu on Days -4 to -2 and then 4 x 10^7 cells/m^2 on Day 0, Day 1 or Day 2
~Dose Level 3:
~Cy/Flu on Days -4 to -2 and then 1 x 10^8 cells/m^2 on Day 0, Day 1, or Day 2"
16113070|NCT02065349|Drug|ASP8477|oral
16113071|NCT02065349|Drug|Placebo|oral
16113072|NCT02065336|Drug|ARC-520|
16113073|NCT02065336|Drug|Placebo|
16113074|NCT02065336|Drug|entecavir|
16113159|NCT02064608|Drug|AZD2014|mTOR inhibitor
16113076|NCT02065323|Drug|Standard ADT|Standard androgen deprivation therapy with either continually dosed LHRH agonist or antagonist, or achieved via bilateral orchiectomy.
16113077|NCT02065323|Drug|Dovitinib|Dovitinib 500 mg/day given on a five-days-on-two-days-off schedule. One cycle equals 28 days. Cycles will repeat continuously until disease progression, or removal from study for other reasons.
16113078|NCT02065310|Other|N2-(1-carboxyethyl)-2'deoxyguanosine (CEdG)|"Glucose and its adducts, such as HbA1c, decompose non-enzymatically to yield α-oxo-aldehydes are up to 20,000 x more reactive than the parent molecule. Amounts of an α-oxo-aldehyde, methylglyoxal (MG), are elevated up to 6-fold in patients with Type 1 dm. Quantitation of MG, but MG does form stable, irreversible adducts termed advanced glycation endproducts (AGEs) that can be measured. MG also reacts with DNA to yield primarily one stable DNA-AGE, CEdG, and suggests that measuring CEdG might allow for a direct method for assessing glycemic status and α-oxo-aldehyde burden.
~Investigators have shown that CEdG levels are significantly elevated in urine and tissue of Type 1 & 2 dm animal models. DNA-AGE may correlate with the development of diabetes complications and identify patients at higher risk. Therefore, the investigators hypothesize that CEdG, a DNA-AGE, can be used as a marker of diabetes control and complications."
16113079|NCT02065297|Other|1 blood sample|
16113080|NCT02065297|Other|2 to 3 blood samples (at inclusion, at 3 months and at 6 months in cases of relapse)|
16113081|NCT02065284|Other|Rhythmic Auditory Stimulation (RAS)|Rhythmic Auditory Stimulation (RAS) is a music therapy technique that provides rhythmic auditory cues (like a beat) to help improve patients' movements, especially when walking.
16113082|NCT02065271|Dietary Supplement|herbal supplement|
16113083|NCT02065271|Other|placebo supplement|
16113084|NCT02065258|Other|Breathing exercise|"It will be based on Yoga´s breathing technique (Eliade, 1996) and will be focus on to stimulate nasal and diaphragmatic breathings, to increase expiratory time, to slow respiratory flow and to regulate the breathing rhythm. Breathing exercises will be divided into 3 phases (lasting one month each) with progressive intensity every 8 sessions.
~All participants will be required to maintain their normal medical regimens during the interventions. Will be part of the routine of breathing exercises the following exercises: I) Kapalabhati, II) Uddhiyana"
16113085|NCT02065258|Other|Aerobic exercise|Exercise will be performed on a treadmill (Imbramed Export Plus, Brazil) with the initial intensity of 60% of the maximum predicted heart rate for patient´s age (Tanaka et al, 2001) reaching a maximal of 80% during the training. The intensity values will be calculated using Karvonen's formule (1957). Exercise intensity will be increased if the patient do not present any increase in asthma symptoms during the exercise for 2 consecutive training days. Before and after every session, patients will perform a peak expiratory flow test and if values were lower than 70% of the patient´s maximum value, they will be advised to use the rescue dose of bronchodilator prescribed the their physician
16113086|NCT02065245|Biological|Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs)|Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion
16113087|NCT02065245|Biological|Placebo|Placebo administered by peripheral intravenous infusion.
16113088|NCT02065245|Biological|Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs)|Penicillin/Streptomycin-Free Allogeneic Human Mesenchymal Stem Cells (allo-hMSCs) administered by peripheral intravenous infusion.
16113089|NCT02065232|Drug|Tilmanocept|
16113090|NCT02065232|Drug|Sulfur Colloid|
16113091|NCT02065219|Drug|Bupivacaine|10 ml of bupivacaine 2.5 mg/ml deposited by ultra-sound guidance around the spermatic cord
16113092|NCT02065219|Drug|Placebo|10 ml 0.9% physiological saline deposited by ultra-sound guidance around the spermatic cord
16113093|NCT02065193|Behavioral|ADOS/ADI-R/Clinical assessment|
16113094|NCT02065180|Dietary Supplement|commercially available nutrition supplement|the food supplement contains red rice yeast and olive extract
16113095|NCT02065180|Dietary Supplement|placebo|
16113096|NCT02065167|Biological|Cultured autologous Mesenchymal Cells|Cultured Mesenchymal Cells from bone marrow isolation, expanded under GMP protocol in associated facilities and introduced at the end of the appropriate forage up to the femoral head under fluoroscopic control.
16113097|NCT02065154|Drug|Cyclophosphamide|
16113098|NCT02065141|Other|sip feeding with stable isotope infusion|such as glycerol, D2O, tyrosine, phenylalanine, glucose, arginine, and citrulline
16113099|NCT02065128|Other|Capsaicin cough challenge test|The capsaicin cough challenge testing will be conducted in the pulmonary function laboratory at SMH by a pulmonary function technologist. The test involves having the participant inhale increasing concentrations of capsaicin solutions and assessing their response. The tidal breathing method and solution preparation presented by Nejla, et al. 12 will be used to conduct this testing. The tidal breathing method is preferred to the alternative dosimeter method as it produces similar results with lower capsaicin concentrations thereby resulting in less throat irritation for the participant. The technique is detailed in the following sections.
16113100|NCT02065115|Other|Cryotherapy (ice pack)|
16113101|NCT02065089|Other|playing the ipad quiz game|Individualized education to the patient via the quiz game, with optional additional education provided by medical providers.
16113102|NCT02065076|Drug|Sodium polystyrene sulfonate|
16113103|NCT02065076|Drug|Lactose with carob gum|
16113104|NCT02065063|Drug|Trametinib|Trametinib is available as a 0.5 mg yellow oval tablet or as a 2.0 mg pink round tablet.
16113105|NCT02065063|Drug|Palbociclib|Palbociclib is available as a 75 mg (size 2 sunset yellow) or 100 mg (size 1 sunset yellow/caramel) or 125 mg (size 0 caramel) capsule.
16113106|NCT02065050|Other|team-based care|Patients in the eDMS arm are called at least every month for their diabetes treatment.
16113107|NCT02065037|Device|room temperature air insufflation|control arm
16113108|NCT02065037|Device|warmed carbon dioxide insufflation|comparator arm
16113109|NCT02065024|Dietary Supplement|b-cryptoxanthin plus phytosterols|
16113110|NCT02065011|Drug|Blood draw for the laboratory assessment|
16113111|NCT02064998|Behavioral|Promillekoll|Smartphone app monitoring alcohol use with feedback on eBAC level.
16113112|NCT02064998|Behavioral|PartyPlanner|Smartphone-adapted web-based app for simulating an event with alcohol consumption in advance, real time monitoring of alcohol use with eBAC feedback during the event and later possibility of comparison between the plan and the event.
16113247|NCT02063945|Drug|Risperidone|As stated in arm/group
16113113|NCT02064998|Behavioral|TeleCoach|Smartphone app providing exercises and vignettes for reducing or abstaining from alcohol consumption.
16113114|NCT02064985|Drug|"Inhibition of Platelet Aggregation by Brilinta(Ticagrelor)"|To determine the Inhibition of Platelet Aggregation (IPA) profiles of single and multiple doses of ticagrelor 45, 60, and 90 mg in Chinese patients with stable coronary heart disease (CHD) on chronic low dose ASA (75-100mg daily).
16113115|NCT02064972|Other|Patients undergoing allo-HSCT, who manifest GvHD.|Changes in CEC counts in relation to GvHD ONSET
16113116|NCT02064959|Device|Temperature management Zoll Intravascular Temperature Management device|
16113117|NCT02064946|Dietary Supplement|vitamin D|50,000IU/week of vitamin D3
16113118|NCT02064946|Dietary Supplement|Placebo|
16113119|NCT02064920|Drug|Placebo|Placebo for donepezil hydrochloride capsule
16113120|NCT02064920|Drug|Donepezil|5 mg donepezil hydrochloride capsule.
16113121|NCT02064920|Drug|Donepezil|10 mg donepezil hydrochloride capsule.
16113122|NCT02064907|Drug|Dexlansoprazole Delayed Release Orally Disintegrating Tablets|Dexlansoprazole delayed-release, orally disintegrating (OD) tablets
16113123|NCT02064907|Drug|Dexlansoprazole Delayed Release Capsules|Dexlansoprazole delayed-release capsules
16113124|NCT02064894|Drug|oral morphine and oral ibuprofen|The combination of oral morphine and oral ibuprofen is one of the Experimental arm group
16113125|NCT02064894|Drug|Oral morphine|Oral morphine 0.2 mg/kg (syrup) up to a maximum dosage of 15 mg, administered once during the study
16113126|NCT02064894|Drug|Oral ibuprofen|oral ibuprofen combine to a placebo is the active comparator
16113127|NCT02064881|Drug|Metformin glycinate|All patients are going to begin the treatment with one tablet orally at night, 30 minutes before dinner (1 tablet of 620 mg glycinate metformin or one 500 mg tablet of metformin hydrochloride) and the dose will be administrated every 3 days to complete the dose of 2 tablets in the morning 30 minutes before breakfast and 2 tablets in the evening 30 minutes before dinner (1240 mg metformin glycinate every 12 hours or 1000 mg metformin hydrochloride every 12 hrs) .
16113128|NCT02064881|Drug|Metformin Hydrochloride|All patients are going to begin the treatment with one tablet orally at night, 30 minutes before dinner (1 tablet of 620 mg glycinate metformin or one 500 mg tablet of metformin hydrochloride) and the dose will be administrated every 3 days to complete the dose of 2 tablets in the morning 30 minutes before breakfast and 2 tablets in the evening 30 minutes before dinner (1240 mg metformin glycinate every 12 hours or 1000 mg metformin hydrochloride every 12 hrs)
16113129|NCT02064868|Drug|Serelaxin|30 µg/kg/day IV infusion
16113130|NCT02064868|Drug|Standard of Care|This treatment can include but is not limited to intravenous and/or oral diuretics, angiotensin-converting enzyme (ACE) inhibitors/angiotensin receptor antagonists, beta blockers and aldosterone receptor antagonists, etc.
16113131|NCT02064842|Drug|TMC647055|TMC647055 150 mg (1 capsule), 450 mg (3 capsules), 600 mg (4 capsules) taken orally (by mouth) once daily on Day 1 in Part 1. TMC647055 450 mg (3 capsules), and 600 mg (4 capsules) taken orally once daily on Days 1 to 7 in Part 2
16113132|NCT02064842|Drug|TMC435|TMC435 1 capsule of 75 mg, 100 mg, and 150 mg taken orally on Days 1 to 7 in Part 2
16113133|NCT02064842|Drug|Placebo|Placebo capsule once daily taken orally on Day 1 in Part 1
16113134|NCT02064842|Drug|Ritonavir (RTV)|RTV 30 mg (ie, 0.38 mL oral solution of RTV [80 mg/mL strength]) taken orally on Day 1 in Part 1 and on Days 1 to 7 in Part 2
16113135|NCT02064829|Drug|Nab-paclitaxel|260 mg/m2 administered intravenously over 30 minutes on Day 1 every 3 weeks
16113136|NCT02064829|Drug|IG-001|260 mg/m2 administered intravenously over 30 minutes on Day 1 every 3 weeks
16113137|NCT02064816|Drug|Rebif®|Rebif® will be administered at a dose of 44 microgram (mcg) subcutaneously three times a week in the morning using RebiSmart® self-injector device for 12 weeks.
16113138|NCT02064816|Drug|Rebif®|Rebif® will be administered at a dose of 44 mcg subcutaneously three times a week in the evening using RebiSmart® self-injector device for 12 weeks.
16113139|NCT02064803|Procedure|Gastro-entero anastomosis only|Gastro-entero anastomosis only
16113140|NCT02064803|Procedure|Gastric partitioning Plus Gastro-entero anastomosis|Gastric partitioning Plus Gastro-entero anastomosis
16113141|NCT02064777|Drug|Tacrolimus|
16113144|NCT02064751|Device|CRT with MultiPoint Pacing|
16113145|NCT02064751|Procedure|Hemodynamic measurements for CRT device programming|
16113146|NCT02064738|Behavioral|Restricting daily intake of omega-6 fatty acids to less than 4 grams and increasing omega-3 fatty acids to 3 grams|
16113147|NCT02064725|Drug|Sodium cridanimod|Eligible patients will be enrolled into the study and administered sodium cridanimod (500 mg i.m./ twice a week) in combination with megestrol acetate (160 mg p.o./ day) or medroxyprogesterone acetate (200 mg p.o./ day).
16113148|NCT02064712|Other|Low CPAP Wean|Infants receive NCPAP by Hudson nasal prongs.
16113149|NCT02064712|Other|High CPAP Wean|Infants receive NCPAP by Hudson nasal prongs.
16113150|NCT02064699|Biological|CMV Infection|"Routine follow-up (viral load, creatininaemia, neutrophil count, isolation of CMV strains when possible) and biological sample collection for.
~Using the QuantiFERON-CMV test for predicting the risk of CMV infection in the transplanted immune against CMV."
16113151|NCT02064686|Other|Exhaled breath temperature|
16113152|NCT02064673|Drug|Curcumin|Curcumin or placebo 500mg by mouth twice a day for 6 months
16113153|NCT02064673|Drug|placebo|placebo orally twice a day
16113154|NCT02064660|Device|massager|The patients will be doing self-stimulation using acupressure device, The acupuncture treatment will be applied two times per day for six months. Acupressure divice will stimulate for 14 minutes. Examples of acupuncture points to be used might include GB1, GB14, TE23, ST1, ST2, BL01, BL02, the Extra-point Tae-yang, In-dang.
16113155|NCT02064647|Other|Trend Arrow Adjustment Tool|The Trend Arrow Adjustment Tool formula is: if CGM shows a single arrow up or down: adjust bolus by +/- (1.5/ISF) and for 2 arrows up or down +/- (3/ISF). Where ISF is the patients own insulin sensitivity factor.
16113156|NCT02064647|Other|10/20% bolus adjustment|The 10/20% bolus adjustment formula is: if CGM shows a single arrow up or down: adjust bolus by +/- 10% and for 2 arrows up or down +/- 20%.
16113157|NCT02064621|Drug|Candesartan 32mg|Candesartan 32mg 1T, PO, QD for 9days
16113369|NCT02062905|Other|Placebo Vehicle|
16113163|NCT02064582|Drug|Leuprolide acetate|22.5 mg intramuscular every 3 months or 45mg intramuscular every 6 months
16113164|NCT02064582|Radiation|radiation|External beam radiation will be delivered as per standard radiation therapy protocol
16113165|NCT02064569|Genetic|GS010|
16113166|NCT02064556|Drug|Amlodipine 10mg|Amlodipine 10mg 1T, PO, QD for 9days
16113167|NCT02064556|Drug|Amlodipine 10mg/Candesartan 32mg|Amlodipine 10mg 1T, PO, QD for 9days/Candesartan 32mg 1T, PO, QD for 9days
16113168|NCT02064543|Other|GAITRite|mobility test assessing gait parameters
16113169|NCT02064543|Other|ADPM|mobility test assessing gait parameters
16113170|NCT02064530|Drug|Bupivacaine|21 ml 0.5 %bupivacaine is applied interfasially
16113171|NCT02064530|Drug|Dexmedetomidine|1 ml dexmedetomidin + 20 ml 0.5 % bupivacaine are applied interfasially
16113172|NCT02064530|Drug|serum physiologic|21 ml serum physiologic is applied interfasially
16113173|NCT02064517|Device|MTA|Creation of a barrier apicale in the MTA
16113174|NCT02064517|Device|Hydroxide of calcium|Revascularisation pulpaire with some hydroxide of calcium
16113175|NCT02064504|Drug|GSK961081|Dry white to off white powder
16113176|NCT02064504|Drug|Fluticasone furoate|Dry white powder
16113177|NCT02064491|Drug|Erlotinib|
16113178|NCT02064491|Drug|Chemotherapy|
16113179|NCT02064465|Drug|Lamotrigine Dispersible/Chewable tablet|Single dose of lamotrigine dispersible/chewable 100mg tablet at Day1
16113180|NCT02064465|Drug|Lamotrigine Compressed tablet|Single dose of lamotrigine compressed 100mg tablet at Day1
16113181|NCT02064452|Other|Triple P Online System|The Triple P Online System (TPOS) is an online parenting support program designed to assist parents in developing effective parenting practices for handling their children's problem behaviors. Content focuses on positive attention and praise, teaching strategies, effective discipline, antecedent strategies to avoid problems in high-risk situations, and applying these principles to specific situations. TPOS integrates 3 different levels of program intensity to meet different levels of family need, based on severity of children's behavior problems.
16113182|NCT02064452|Behavioral|Placebo Comparator|Enhanced Usual Community Care-Waitlist
16113183|NCT02064439|Drug|BAY 59-7939|10 mg tablet once daily for 12 months
16113184|NCT02064439|Drug|BAY 59-7939|20 mg tablet once daily for 12 months
16113185|NCT02064439|Drug|ASA|100 mg tablet once daily for 12 months
16113186|NCT02064426|Drug|Molidustat (BAY85-3934)|Subjects will continue with the same treatment they were receiving in the parent study (16208). BAY85-3934 will be administered daily as oral tablets. Dose assessments will be made every 4 (± 1) weeks. At the scheduled visits, the dose may be titrated on an individualized basis taking into account the subject's Hb response and the tolerability of the previous dose. Total treatment time is up to 36 months. Planned doses include 15, 25, 50, 75, 100, and 150 mg once daily.
16113187|NCT02064426|Biological|Epoetin alfa/beta|Subjects will continue with the same treatment they were receiving in the parent study (16208). Epoetin alfa / beta will be administered as intravenous (IV) or subcutaneous (SC) injections per individual subject regimen according to the local label. Dose assessments will be made every 4 (± 1) weeks. At the scheduled visits,dose may be titrated on an individualized basis taking into account the subject's Hb response and the tolerability of the previous dose.Total treatment time is up to 36 months.
16113188|NCT02064413|Device|ESS310 (BAY1454032)|
16113189|NCT02064400|Other|Musculoskeletal Ultrasound|7-joint musculoskeletal ultrasound scan
16113190|NCT02064400|Other|Semi-structured patient interview|Semi-structured patient interview
16113191|NCT02064387|Drug|GSK2857916|A clear or opalescent solution for IV infusion with unit dose strength of 20 mg/mililiter (mL) for multiple dose levels.
16113192|NCT02064374|Drug|Metformin 500 mg q12h|Metformin will be supplied as 500 mg tablet to be administered orally.
16113193|NCT02064374|Drug|Dolutegravir 50 mg q24h|Dolutegravir will be supplied as 50 mg tablet to be administered orally. To be taken once a day in the morning in Period 2 (Total daily dose 50 mg per day for Cohort 1 only)
16113194|NCT02064374|Drug|Dolutegravir 50 mg q12h|Dolutegravir will be supplied as 50 mg tablet to be administered orally. To be taken 50 mg tablets every 12 hours in Period 2 (Total daily dose 100 mg per day for Cohort 2 only).
16113195|NCT02064361|Other|High intensity exercise|Subjects performed a repeated Wingate protocol for the exercise condition of the study. This consisted of 4, 30 s maximal efforts on a weight-braked cycle ergometer (Monark 894E, Monark Exercise AB, Sweden) with 4 min active recovery between efforts, preceded by a 5 min warm up. The resistance was set at 7.5% bodyweight for the intervals and 2% for the warm up and active recovery periods.
16113196|NCT02064348|Drug|semaglutide|Solution for subcutaneous (s.c., under the skin) injection. Dose escalation to 1.5 mg.
16113197|NCT02064348|Drug|placebo|Solution for s.c. injection or tablets for oral administration
16113198|NCT02064348|Drug|moxifloxacin|Tablets for oral administration
16113199|NCT02064335|Behavioral|Physical activity coaching|Comparison the effects of physical activity coaching and no coaching on different health parameters in diabetic subjects
16113200|NCT02064322|Device|SImmetry Implant|"The SImmetry system is commercially available. The implanted devices consist of a range of thread-tapping cannulated implants designed to transfix the sacrum and ilim, providing stability for intra-articular fusion.
~The SImmetry Surgical Instruments include standard manual surgical instruments used to access and prepare the sacroiliac joint space for intra-articular fusion."
16113201|NCT02064309|Device|Beta-Air device for encapsulation of transplanted human islets|
16113202|NCT02064296|Device|Needle acupuncture (Traditional Acupuncture)|This group will receive needle acupuncture at 3 pairs of sites. The needles will be stimulated with low intensity, low frequency electric current using a constant-current electro-acupuncture device (AS Super 4 digital needle stimulator).
16113203|NCT02064296|Device|Laser acupuncture (Non-traditional Acupuncture)|For non-traditional acupuncture, a laser acupuncture device (Vita Laser 650, Lhasa OMS) will be positioned over all of the same acupoints used in EA. There will be no palpation prior to positioning these devices, and there will be no physical contact between device and skin.
16113204|NCT02064283|Procedure|Diffusion MRI|
16113205|NCT02064270|Device|Single-Use Negative Pressure Wound Therapy|Application of PICO Single-Use Negative Pressure Wound Therapy
16113206|NCT02064270|Device|Standard postsurgical dressings|Use of Standard postsurgical dressings
16113207|NCT02064257|Behavioral|Listening Project Protocol|The intervention will consist of listening to computer-altered acoustic stimulation, designed to modulate the frequency band of vocal music passed to the participant. The frequency characteristics of the acoustic stimulation are selected to emphasize the relative importance of specific frequencies in conveying the information embedded in human speech. Modulation of the acoustic energy within the frequencies of human voice, similar to an exaggerated vocal prosody, are hypothesized to recruit and modulate the neural regulation of the middle ear muscles and to functionally reduce sound hypersensitivities and improve auditory processing.
16113208|NCT02064244|Other|Ultrasound for measurement of Inferior Vena Cava size.|Focused bedside ultrasound will be performed for each patient as part of their routine care and initial assessment. The IVC size will be measured at the subcostal window, during inspiration and expiration, using the Sonosite cardiac probe P-21 (5-1 MHZ). The measurement is obtained by applying the M-mode, perpendicular to the IVC axis and 2 cm caudal from its junction with the right atrium.
16113209|NCT02064231|Device|Coloplast Test A|Coloplast Test A is a new ostomy appliance developed by Coloplast A/S
16113210|NCT02064231|Device|Coloplast Test B|Coloplast Test B is a newly developed ostomy appliance developed by Coloplast A/S
16113211|NCT02064231|Device|Own product|Own product is tested to get baseline results. Own product can be any 2-piece product that is commercially available. The manufactures can be Coloplast, Hollister, Convatec, Dansac, B. Braun and others.
16113212|NCT02064231|Device|Coloplast Test C|Coloplast Test C is a new ostomy appliance developed by Coloplast A/S
16113213|NCT02064231|Device|Coloplast Test D|Coloplast Test D is a new ostomy appliance developed by Coloplast A/S
16113214|NCT02064218|Drug|Anti-hypertensive drugs|
16113215|NCT02064205|Dietary Supplement|12.5 g polydextrose|Appetite suppressing supplement is added in yogurt and provided with breakfast (four hours before lunch) or 1.5h before lunch. Also yogurt with control (glucose syrup) is tested for its satiating effect.
16113216|NCT02064205|Dietary Supplement|glucose syrup|Glucose syrup is used a control product for the polydextrose
16113217|NCT02064166|Drug|Intranasal Insulin|"treatment arm: Insulin, 40 international units daily, intranasally, for 4 weeks;
~placebo arm: normal saline, daily, intranasally, for 4 weeks."
16113218|NCT02064153|Procedure|Cool dialysate|Each recruited patient undergoes a cool dialysate session ( 35.5ºC) and a warm dialysate session (37ºC). The sessions are minimum a week apart to remove the carryover effect.
16113219|NCT02064153|Procedure|Warm dialysate|All recruited patients will undergo two study sessions - Cool dialysis (35.5ºC) and Warm dialysis (37ºC)
16113220|NCT02064140|Drug|Rocuronium|
16113221|NCT02064114|Procedure|Intervention group|Start of optimal management of risk factors, every 2 weeks for 6 months after atrial fibrillation ablation. And followed for a period of 3,6 and 12 months after the procedure.
16113222|NCT02064114|Procedure|control group|Followed for a period of 3,6 and 12 months after the procedure.
16113223|NCT02064101|Procedure|Spinal Fusion|The investigators are studying the use of triggered EMG via the IPC POWEREASE screwdriver (Product Codes HBE, HWE, GWF) during spinal fusion surgery in adolescent idiopathic scoliosis by comparing it to the traditional triggered EMG OrthoMon probe system (Product Codes GWF, IKN).
16113224|NCT02064088|Drug|Injection of 0,2 ml/kg of 0,2% levobupivacaine for small volume group|Ultrasound guided administration of 0,2 ml/kg of 0,2% lévobupivacaine in the plane between the internal oblique and transversus abdominis muscles
16113225|NCT02064088|Drug|Injection of 0,4 ml/kg of 0,1% lévobupivacaine for high volume group|Ultrasound guided administration of 0,4 ml/kg of 0,1% lévobupivacaine in the plane between the internal oblique and transversus abdominis muscles
16113226|NCT02064075|Drug|Lactated Ringer's solution|15-50 ml/kg Lactated-Ringer's solution was given intravenously every day until discharge.
16113227|NCT02064075|Drug|Hydroxyethyl starch|15 ml/kg Lactated-Ringer's and 15-50 ml/kg hydroxyethyl starch solution was given intravenously every day until discharge.
16113228|NCT02064062|Biological|Autologous Mesenchymal Stem Cells|
16113229|NCT02064049|Drug|Sofosbuvir/velpatasvir|The treatment phase will commence in year 2. This is 12 weeks of the pangenotypic sofosbuvir/velpatasvir 400/100mg, coformulated into one tablet daily.
16113230|NCT02064036|Radiation|Stereotactic Radiosurgical Boost|Intensity Modulated Radiotherapy (IMRT)2 with Concurrent Androgen Blockade to Whole Pelvis, Prostate, and Seminal Vesicles Followed by: Stereotactic Radiosurgical Boost3 to the Prostate with Implanted Electromagnetic Transponder Beacon Intrafraction Guidance
16113231|NCT02064036|Drug|Casodex|Neoadjuvant Androgen Blockade before radiation therapy and Adjuvant Androgen Blockade after radiation therapy
16113232|NCT02064036|Drug|Leuprolide|Neoadjuvant Androgen Blockade before radiation therapy and Adjuvant Androgen Blockade after radiation therapy
16113233|NCT02064023|Device|insulin pump|subjects in the experimental arm will administer insulin using a pump
16113234|NCT02064023|Other|multiple daily insulin injection|Subjects will continue with usual insulin injections
16113235|NCT02064010|Drug|SNC-102|Acamprosate calcium (SNC-102) tablet, administered orally for 4 weeks
16113236|NCT02064010|Drug|Placebo|Placebo tablet, administered orally for 4 weeks
16113237|NCT02063997|Drug|Arhalofenate 600 mg|Arhalofenate 600 mg tablets once daily for 12 weeks
16113238|NCT02063997|Drug|Allopurinol 300 mg|Allopurinol 300 mg tablets once daily for 12 weeks
16113239|NCT02063997|Drug|Colchicine 0.6 mg|Colchicine 0.6 mg over-encapsulated tablets once daily for 12 weeks
16113240|NCT02063997|Drug|Placebo|Placebo tablets once daily for 12 weeks
16113241|NCT02063997|Drug|Arhalofenate 800 mg|Arhalofenate 800 mg tablets once daily for 12 weeks
16113242|NCT02063984|Behavioral|Intensive Outpatient Treatment (IOP) + Contingency Management (CM)|Multiple group sessions weekly, one individual counseling session weekly with teen to review and discuss contingency management abstinence-based incentives
16113243|NCT02063984|Behavioral|Working Memory Training|25 computer-delivered sessions of neurocognitive training
16113244|NCT02063971|Other|Soothing (formulation number: F#1048-082) and antiaging creams (F#841-020 and F#1374-002)|
16113245|NCT02063958|Drug|SNX-5422|Capsule dosed every other day for 21 days out of a 28 day cycle. Dose escalation based on safety not to exceed a dose of 100 mg/m2. Maintenance therapy of SNX-5422 at the MTD will be allowed for all patients not experiencing significant toxicity.
16113246|NCT02063945|Drug|Methylphenidate|As stated in arm/group
16113248|NCT02063932|Other|endomicroscopy, targeted biopsy and 16s rRNA gene sequencing|
16113249|NCT02063919|Other|the mucosal microbiome in the biopsy specimen was analysed|
16113250|NCT02063880|Other|Urgent ART|Children will be started on HAART <48 hours after enrollment.
16113251|NCT02063880|Other|Early ART|Children will be started on ART after stabilization 7-14 days after enrollment.
16113252|NCT02063867|Drug|Arm 2: Decolonization|"Daily chlorhexidine (CHG) shower or CHG cloth bath for all non-critical care patients.
~Topical intranasal mupirocin ointment (bilateral nares, twice daily) x5 days if non-critical care patients are MRSA+ by history, culture, or screen."
16113253|NCT02063854|Drug|NE-58095 IR|NE-58095 IR tablets
16113254|NCT02063854|Drug|NE-58095 IR Placebo|NE-58095 IR placebo-matching tablets
16113255|NCT02063854|Drug|NE-58095 DR|NE-58095 DR tablets
16113256|NCT02063854|Drug|NE-58095 DR Placebo|NE-58095 DR placebo-matching tablets
16113257|NCT02063841|Device|lead-free protective drape containing bismuth and antimony (RADPAD®)|
16113258|NCT02063841|Device|sterile identical sham drape|
16113259|NCT02063828|Device|Group A - Device guided breathing low dose|Group A: 15 minutes once a day, 5 days a week for 12 weeks.
16113260|NCT02063828|Device|Group B - Device guided breathing high dose|Group B - 15 minutes twice a day, 5 days a week for 12 weeks.
16113261|NCT02063828|Device|Group C - Usual Breathing Control Group|Group C - 15 minutes per day, 5 days a week for 12 weeks.
16113262|NCT02063815|Procedure|Fissure sealant application|
16113263|NCT02063802|Drug|metformin|total dose: 1 gr per day (250mg tablets). The patient takes 2 tablets with breakfast and 2 tablets with dinner and 2 placebo tablets with food by mouth for four months.
16113264|NCT02063802|Dietary Supplement|Conjugated Linoleic Acid|total dose: 3gr/día(500mg capsules). The patient takes 2 capsules with breakfast, 2 capsules with lunch and 2 capsules with dinner for four months.
16113265|NCT02063802|Drug|Placebo|Total dose 6 tablets per day. The patient takes 2 tablets with breakfast, two tablets with lunch and two tablets with dinner by mouth for four months
16113266|NCT02063802|Behavioral|Healthy habits program|
16113267|NCT02063789|Drug|Human immunoglobulin intravenous|After GC5107A Intravenous injection, evaluate platelet increase
16113268|NCT02063750|Other|strengthening exercises using a Swiss ball|"This group performed eight muscle strengthening exercises using a Swiss ball of 65 cm diameter and dumbbells with different loads.
~Each training session was 40 minutes long and was performed three times a week for 12 weeks. The exercises were performed in three sets of 12 repetitions, with an interval of one to two minutes of recovery between exercises, which alternated between upper limbs, lower limbs and abdomen. The load used was 60 % of one repetition maximum (1RM)."
16113269|NCT02063750|Other|strengthening exercises|The stretching group performed stretching exercises that targeted the same muscles trained in the IG. The participants remained in the stretched position for three sets of 30 s for each exercise. The total session time was 40 minutes.
16113270|NCT02063737|Behavioral|Text-message assessments only|Text message assessments only. No intervention for high level fatigue.
16113271|NCT02063737|Behavioral|Text-message interventions for high level fatigue|Intervention messages to promote alertness while on duty at work including activities. Additionally at the end of the shift, participants were queried on their adoption of the suggested activities and perception of the activities' effectiveness.
16113272|NCT02063724|Biological|HER-2 pulsed Dendritic Cell Vaccine|6 weekly HER-2 pulsed dendritic cell vaccines followed by 3 booster vaccines once every 3 months. Each dose will consist of between 1.0-2.0 x 10^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.
16113273|NCT02063711|Behavioral|Yoga intervention|
16113274|NCT02063698|Drug|auranofin|Given PO
16113275|NCT02063698|Other|placebo|Given PO
16113276|NCT02063698|Other|questionnaire administration|Ancillary studies
16113277|NCT02063685|Drug|R-CHOP or R-bendamustine|"As induction therapy all patients will receive 6 courses of:
~Rituximab: 375 mg/m² day 1 iv Cyclophosphamide: 750 mg/m² day 1 iv Doxorubicin: 50 mg/m² day 1 iv Vincristine: 1.4 mg/m² day 1 iv (max dose 2mg) Prednisone: 100 mg day 1-5 os To allow administration of all drugs on the same day, Rituximab rapid infusion is permitted starting from cycle 2. Cycles are to be repeated every 21 days.
~or 6 courses of:
~Rituximab: 375 mg/m² day 1 iv Bendamustine: 90 mg/m² day 1 and 2 iv. To allow administration of all drugs on the same day, Rituximab rapid infusion is permitted starting from cycle 2. Cycles are to be repeated every 28 days."
16113278|NCT02063685|Drug|Observation|not maintenance therapy and followed-up with MRD monitoring.
16113279|NCT02063685|Drug|Maintenance weekly x4|Four weekly doses of Rituximab (375 mg/m²). Rituximab could be repeated for MRD positive for a maximum of three courses
16113280|NCT02063685|Drug|Ibritumomab Tiuxetan + Maintenance|single dose of (90)Y Ibritumomab Tiuxetan (0.4 mCi/kg). Following RIT patients will continue maintenance with Rituximab (375 mg/m² every 2 months) for a total of 11 infusions.
16113281|NCT02063685|Drug|Standard Maintenance|Rituximab 375 mg/m² every 2 months for 2 years. Maintenance will have to be started no more than 12 weeks after the last induction chemoimmunotherapy infusion.
16113282|NCT02063672|Device|Lutonix DCB|
16113283|NCT02063672|Device|Standard Uncoated Balloon Angioplasty Catheter|PTA Catheter
16113284|NCT02063659|Drug|Telotristat etiprate|Telotristat etiprate tablets
16113285|NCT02063659|Drug|Placebo|Placebo-matching telotristat etiprate tablets
16113286|NCT02063646|Dietary Supplement|Polyphenol-rich extract|Two groups, each of 102 volunteers, are studied. For 24 weeks, one group of volunteers will consume the active product (polyphenol-rich extract) while the other one will consume the placebo product.
16113287|NCT02063646|Dietary Supplement|Placebo|"The placebo is a capsule with same appearance and organoleptic properties as the active product, containing no active component.
~Two groups, each of 102 volunteers, are studied. For 24 weeks, one group of volunteers will consume the active product (polyphenol-rich extract) while the other one will consume the placebo product."
16113288|NCT02063620|Drug|Ketamine HCL|ketamine HCL is using as adjuvant agent with local anesthetic agent in regional intravenous anesthesia procedure routinely
16113289|NCT02063607|Biological|Peginterferon lambda|
16113290|NCT02063594|Drug|NCTX (PEGylated Liposomal Iodixanol Injection)|Single dose of NCTX (PEGylated Liposomal Iodixanol Injection) administered at escalating doses from 9 mg I/kg up to 110 mg I/kg
16113291|NCT02063594|Drug|Saline Placebo|Single dose of 0.9% Sodium Chloride Injection, USP administered similarly and at an equivalent dose volume as the active drug
16113292|NCT02063581|Drug|ipatasertib (Capsule)|Orally administered single dose of Ipatasertib formulated as a capsule.
16113293|NCT02063581|Drug|ipatasertib (Tablet)|Orally administered single dose of Ipatasertib formulated as a tablet.
16113294|NCT02063568|Drug|Oxytocin|
16113295|NCT02063555|Biological|DAR-901|
16113296|NCT02063555|Biological|BCG|
16113297|NCT02063555|Biological|Sterile saline|
16113298|NCT02063529|Drug|FOLFOXIRI + Cetuximab|Cetuximab 500mg/m² + irinotecan* 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle until PD or resectability or to max. 12 cycles
16113299|NCT02063529|Drug|FOLFOXIRI|Irinotecan* 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 2800 mg/m² cont. inf. 46h all on day 1 of each 2 weeks cycle until PD or resectability or to max. 12 cycles
16113300|NCT02063516|Device|Guardian Laryngeal Mask|Guardian Laryngeal Mask: The Guardian Laryngeal Mask (Ultimate Medical Pty Ltd, Richmond, Vic, Australia) is a new silicone-based single-use extraglottic airway device that forms a seal with the glottis for ventilation and with the hypopharynx for airway protection, and provides a gastric drainage port. In addition, it has a port for suctioning material from the hypopharynx and a pilot balloon valve that constantly monitors intracuff pressure. In the following randomized, non-crossover study, the investigators test if oropharyngeal leak pressures differed between the Guardian Laryngeal Mask and the LMA proseal in paralysed, anaesthetised patients.
16113301|NCT02063516|Device|Proseal Laryngeal Mask Airway|Proseal Laryngeal Mask Airway: Silicon based, reusable, modified dorsal cuff and drainage tube
16113302|NCT02063503|Other|physiotherapy|every group receives 2 treatments every week during 9 consecutive weeks
16113303|NCT02063490|Behavioral|Adherence support|"One-time preparatory intervention offering adherence prerequisites (knowledge, social support and skills)
~+ One-year monthly individualised counselling sessions with a standardised intervention sheet listing the most prevalent problems with possible solutions"
16113304|NCT02063477|Dietary Supplement|Placebo|The placebo composition is for 1 gelule: 250 mg maltodextrin + 30 mg magnesium stearate; total weight: 280 mg/gelule
16113305|NCT02063477|Dietary Supplement|Oligopin®|"Oligopin® PUR' expert (%) is a red brown powder extracted from the bark of the Maritime Pine (Pinus pinaster) with composition:
~- TOTAL POLYPHENOL CONTENT > 96
~MONOMERS + PHENOLIC ACIDS 30
~DIMERS >15
~OTHER OLIGOMERS 50
~PROCYANIDINS CONTENT (GPC) > 67
~The Oligopin composition is for 1 gelule: 75 mg Oligopin + 175 mg maltodextrine + 30 mg magnesium stearate: total weight: 280 mg/gelule"
16113306|NCT02063451|Dietary Supplement|Very Low Calorie Diet (VLCD)|Very Low Calorie Diet (VLCD) using the HMR meal replacement (Health Management Resources, Boston, MA). Typically, individuals consume 850-1000 kilocalories per day until a targeted 15% reduction in body weight is achieved.
16113307|NCT02063438|Procedure|Pericostal suture technique|
16113308|NCT02063438|Procedure|Intracostal suture technique|
16113309|NCT02063425|Drug|Fluoxetine|1 pill of 20mg / day, during 3 months
16113310|NCT02063425|Drug|Placebo of fluoxetine|1 pill of 20mg/day, during 3 months
16113311|NCT02063386|Drug|AZD1722|Single oral dose 15 mg of [14C]AZD1722
16113312|NCT02063373|Other|Hyaluronic acid|treatment: Weekly intra-articular hyaluronic acid injection (20 MG / 2ML) into both knees for five weeks.
16113313|NCT02063360|Drug|BMS-663068|BMS-663068
16113314|NCT02063360|Drug|Darunavir (DRV)|Darunavir (DRV)
16113315|NCT02063360|Drug|Ritonavir (RTV)|Ritonavir (RTV)
16113316|NCT02063360|Drug|Etravirine (ETR)|Etravirine (ETR)
16113317|NCT02063334|Dietary Supplement|Vitamin D3|In total 25 pills will be taken by the subjects, each containing 80 micrograms of vitamin D3 or placebo. Of the 25 pills, 13 will be taken in the morning with breakfast and 12 with lunch.
16113318|NCT02063334|Dietary Supplement|Placebo|
16113319|NCT02063308|Dietary Supplement|Oxaloacetate (OAA)|
16113320|NCT02063295|Drug|ZGN-440 sterile diluent|ZGN-440 sterile diluent/placebo
16113321|NCT02063295|Drug|ZGN-440 for injectable suspension|
16113322|NCT02063269|Drug|Rivastigmine|9-18mg/rivastigmine for 52 weeks
16113323|NCT02063256|Dietary Supplement|7 nuts a day|add 7 nuts a day (whole shelled weight 75 grams) to standard diet
16113324|NCT02063256|Other|Diet modification|modify the diet allowing more intake of PUFA rich food and cutting the consumption of saturated fatty acids
16113325|NCT02063243|Procedure|Intralesional cryotherapy|Intralesional (IL) cryotherapy is a treatment for keloids and hypertrophic scars, in which the scar is frozen from inside with the use of a cryoneedle
16113326|NCT02063230|Drug|Selumetinib 50mg|HV and hepatic impaired patients with mild and moderat severity will recived selumetinib 50mg orally on day 1
16113327|NCT02063230|Drug|Selumetinib 25mg|Severe (Child Pugh C) hepatic impaired patients will receive selumetinib 25mg orally on Day 1
16113328|NCT02063217|Drug|Sodium Oxybate|Sodium oxybate h.s.
16113329|NCT02063217|Behavioral|Sleep deprivation|36hr sleep deprivation
16113330|NCT02063204|Drug|selumetinib|selumetinib 50 mg (2x25mg) administered by mouth as capsules
16113331|NCT02063178|Behavioral|Phone-based sessions (28 total) on a structured schedule|28 sessions will be reviewed weekly and then bi-weekly with a trained motivational interviewing counselor for those individuals randomly assigned to the counselor-initiated condition.
16113332|NCT02063178|Behavioral|Phone-based sessions upon request|For those individuals randomly assigned to the self-paced condition, the 28 sessions are still available to them, the participant has to call to initiate sessions.
16113333|NCT02063178|Behavioral|Weight self-monitoring|Each randomized participant will be given a Body Trace scale that will electronically record their weight.
16113334|NCT02063178|Behavioral|Dietary and physical activity self-monitoring|Each randomized participant will be given a free account to Lose It! Premium, an online food/activity diary for self-monitoring.
16113335|NCT02063178|Behavioral|Scheduled tailored interventionist feedback|Randomly assigned participants to the counselor-initiated condition will receive feedback on their progress throughout their sessions with their assigned interventionist.
16113336|NCT02063178|Behavioral|Dietary goals|Each randomized participant will receive a daily calorie goal range based on their current weight, gender, and BMI.
16113406|NCT02062632|Drug|Doxepin Hydrochloride|Given orally
16113337|NCT02063178|Behavioral|Meal replacements|Randomized participants will receive coupons for meal replacements including oatmeal and popcorn.
16113338|NCT02063178|Behavioral|Physical activity goals|Each participant will complete the Global Physical Activity Questionnaire which will determine their weekly exercise goals.
16113339|NCT02063178|Behavioral|Toolbox|The toolbox includes additional treatment options for those who wish to take advantage of them. Items may include: food scales, cookbooks, etc. These items may be checked out and must be returned prior to the completion of the study.
16113340|NCT02063178|Behavioral|Challenges|There will be several challenges designed to increase participant interest and provide a specific goal (e.g., increase self-monitoring). Participants who successfully completed the challenges will be given a small award.
16113341|NCT02063178|Behavioral|Tailored interventionist feedback upon request|Randomly assigned participants to the self-paced condition have the option to receive feedback on their progress upon request.
16113342|NCT02063165|Dietary Supplement|High Linoleic Safflower Oil|2 tsp per day (~10g of oil)
16113343|NCT02063139|Drug|Flutiform 50/5 ug (2 puffs bid) pMDI|
16113344|NCT02063139|Drug|Fluticasone 50 ug (2puffs bid) pMDI|
16113345|NCT02063139|Drug|Beclometasone Autohaler 50 ug (2 puffs bid)|
16113346|NCT02063126|Dietary Supplement|ReConnect (NADH plus CoQ10)|"ReConnect supplementation (NADH: 20 mg/day plus CoQ10: 200mg/day) divided into two daily dose ( 2 tablets/ before breakfast and 2 tablets/ before lunch)
~Placebo supplementation divided into two daily dose ( 2 tablets/ before breakfast and 2 tablets/ before lunch)"
16113347|NCT02063126|Dietary Supplement|placebo|placebo (phosphoserine/serine plus vitamin C) supplementation divided in two daily doses (2 tablets/before brekfast and 2 tablets/before lunch)
16113348|NCT02063113|Other|Vulnerability and therapeutic changes in older patients with multiple myeloma.|
16113349|NCT02063100|Drug|Shenyankangfu tablets|Shenyankangfu tablets 2.4g, po, 3/day and Losartan potassium placebo 2 tab, po, 1/day,all drugs and placebo are taken for 48 weeks.
16113350|NCT02063100|Drug|Losartan potassium 50mg|Shenyankangfu tablets placebo 5 tab, po, 3/day and losartan potassium 50mg,po, 1/day and losartan potassium placebo1 tab,po, 1/day, all drugs and placebo are taken for 48 weeks.
16113351|NCT02063100|Drug|Shenyankangfu tablets and Losartan potassium 50mg|Shenyankangfu tablets 2.4g, po, 3/day and losartan potassium 50mg,po, 1/day and losartan potassium placebo1 tab, po, 1/day, all drugs and placebo are taken for 48 weeks.
16113352|NCT02063100|Drug|Shenyankangfu tablets and Losartan potassium 100mg|Shenyankangfu tablets 2.4g, po, 3/day and losartan potassium 50mg×2,po, 1/day, all drugs and placebo are taken for 48 weeks.
16113353|NCT02063100|Drug|Losartan potassium 100mg|Shenyankangfu tablets placebo 5 tab, po, 3/day and losartan potassium 50mg×2,po, 1/day, all drugs and placebo are taken for 48 weeks.
16113354|NCT02063087|Other|Head CT Decision Aid|The decision aid, Head CT Choice, educates parents regarding how the clinician determined the severity of their child's head trauma, their child's quantitative risk for a clinically-important TBI, the pros and cons of cranial CT compared to active observation, and what signs and symptoms parents should watch for in the next 24 hours that should prompt a return visit to the ED.
16113355|NCT02063061|Device|Sham treatment|Patients will receive simulated treatment, with the same ESWT unit as in other arm. Placebo gel-pad is design to prevent shockwaves emission. Looks identical as active gel-pad.
16113356|NCT02063061|Device|ESWT treatment|ESWT treatment group will receive 600 low-energy, linear shockwaves against erectile dysfunction per week in 10 weeks.
16113357|NCT02063048|Behavioral|Text Message Based Weight Loss Support|
16113358|NCT02063035|Drug|Tranexamic Acid|A single topical application of 3 grams (g) of Tranexamic acid in 100 milliliter (mL) saline.
16113359|NCT02063035|Drug|Placebo|A single topical application of matching placebo, which is 100 mL of normal saline.
16113360|NCT02063022|Drug|Standard treatment (as per protocol ISG SSG III)|Induction treatment with: 4 cycle of Vincristine (9mg/,2), Dactinomycin (6mg/m2), Doxorubicin (160mg/m2), Cyclophosphamide (2.4g/m2), Ifosfamide (18g/M2) and Etoposide (450mg/m2) given every 3 weeks Maintenance treatment for poor responder (25 weeks): Vincristine (12mg/m2), Dactinomycin (1.5mg/m2), Doxorubicin (320mg/m2), Ifosfamide (27g/m2), Cyclophosphamide (8.8g/m2), Etoposide (1.5g/m2) and peripheral Cells Steam Transplant after Busulfan and Melphalan treatment Maintenance treatment (37 week) for good responder: Vincristine (18mg/m2), Dactinomycin (6mg/m2), Doxorubicin (400mg/m2), Ifosfamide (72g/m2), Cyclosphosphamide(6g/m2), Etoposide (1.8 g/m2)
16113361|NCT02063022|Drug|Intensified chemotherapy|"Induction treatment with: 4 cycle of Vincristine (10.5 mg/m2), Doxorubicin (320 mg/m2) and Ifosfamide (36 mg/m2) given every 3 weeks
~Maintenance treatment for poor responder (25 weeks): Vincristine (12mg/m2), Doxorubicin (400mg/m2), Ifosfamide (63g/m2), Cyclophosphamide (4g/m2), Etoposide (1.5g/m2) and Cells Steam Transplant after Busulfan and Melphalan treatment
~Maintenance treatment (25 week) for good responder: Vincristine (12mg/m2), Doxorubicin (400mg/m2), Ifosfamide (72g/m2), Etoposide (1.8g/m2)"
16113362|NCT02062996|Drug|Oxymetazoline|
16113363|NCT02062983|Drug|Herceptin|"Herceptin will be administered in different way per each setting as follow::total herceptin cycles are 18.
~Neu Adjuvant : chemo+herceptin, Surgery (hold herceptin) , Resume herceptin for 1 year period Adjuvant : Surgery, chemo+herceptin for 1 year period Metastatic : chemo+herceptin until progression."
16113364|NCT02062970|Biological|blood draw|
16113365|NCT02062944|Drug|Sirolimus|SRL minimization will be performed if clinically, biochemically and histologically stable. Patients entering the minimization phases will be reduced every month by 50% of total dose of Sirolimus until they reach .5mg daily for one month. Then .5 mg every other day, then twice weekly, the once weekly dosing. This should take approximately 6 month to complete minimization. Liver function tests will be monitored every 2 weeks. For any patient developing liver dysfunction, liver biopsy will be performed. Patients will then be completely withdrawn and followed post-withdrawal for 12 months.
16113366|NCT02062931|Biological|Stem Cell Preparation and Injection|"Stem Cells 60 ml of bone marrow will aspirated using local anathesia and used for stem cells isolation. Then stem cells will cultured using autologous serum, characterized and prepared.
~Blood sample drawn from venous blood centrifuged and then platelets rich plasma (PRP) collected. The purified and collected stem cells suspended in platelets rich plasma (PRP) using GMP rules and finally injected into ovarian tissues and ligaments .
~Stem Cell Dose: 3-5 Million Autologous MSCs Injected into Ovarian tissue."
16113367|NCT02062918|Device|Abdominal belt|
16113368|NCT02062905|Drug|Dexamethasone|
16113370|NCT02062892|Drug|Everolimus|Patients will be stable kidney transplant patients who are receiving an immunosuppressive drug regimen based on tacrolimus and sirolimus. 24 hours after the last sirolimus dose, the patients randomized to the tacrolimus/everolimus arm of the study will be switched from sirolimus to everolimus 1:1 (same sirolimus as everolimus dose). Everolimus doses will be adjusted so that trough blood concentrations are within 3-8 ng/mL. In detail: Tacrolimus (Prograf or FDA approved generic 0.5 mg, 1 mg or 5 mg capsules, twice a day) in combination with Everolimus (Zortress, 0.25, 0.5 and 0.75 tablets).
16113371|NCT02062892|Drug|Sirolimus|Patients will be stable kidney transplant patients who are receiving an immunosuppressive drug regimen based on tacrolimus and sirolimus. 24 hours after the last sirolimus dose, the patients randomized to the tacrolimus/sirolimus arm of the study will remain on tacrolimus/sirolimus. In detail: Tacrolimus (Prograf or FDA approved generic 0.5 mg, 1 mg or 5 mg capsules, once a day) in combination with Sirolimus (Rapamune, 0.5, 1, and 2mg tablets).
16113372|NCT02062879|Drug|Ketamine|Ketamine administered as patient-controlled analgesia.
16113373|NCT02062879|Drug|Hydromorphone|Hydromorphone administered as patient-controlled analgesia.
16113374|NCT02062866|Procedure|Purse-String|"The wound will be closed using one, long, continuous suture which will enter and exit run through the skin along the inner edge of the wound. The start and stopping point will be adjacent to one another. The suture will then be pulled on either side to essentially cinch down the wound, decreasing the size of the wound."
16113375|NCT02062866|Procedure|Second Intent|The wound will not be sutured, and allowed to heal on its own.
16113376|NCT02062853|Other|Video Group|Subjects will view a brief video today (about 5 minutes long) that provides information on the cream medication that will be used for treatment of your actinic keratoses.
16113377|NCT02062853|Other|Verbal Group|The physician will provide information about the cream medication for the treatment of actinic keratoses through a regular conversation.
16113378|NCT02062840|Device|High intensity whole-body infrared heating|The Whole Body Hyperthermia system uses water-filtered infrared-A (wIRA) heat radiation. The rise in the body's core temperature is correspondingly rapid and well-tolerated. There are two phases of the thermal challenge, 1) Irradiation phase during which the patient lies recumbent with his/her head positioned outside the tent. The wIRA irradiators are arranged above the exposed upper part of the body; and 2) Heat retention phase during which the patient lies in the chamber with the walls of the tent positioned to retain heat. Core body temperatures will be raised to those comparable to a mild fever 37.8-38.5°C.
16113379|NCT02062840|Device|Low intensity whole-body infrared heating|Attenuated heating using only heating coils at the bottom of the Heckel device. This results in only a minor increase in skin temperature and no increase in core body temperature. The participant will still feel heat and will see similar lighting and hear similar sounds as those occurring during actual WBH, and will be in the chamber for the same period of time.
16113380|NCT02062840|Device|Functional Magnetic Resonance Imaging (fMRI) and electrocardiogram (EKG)|A standard magnetic resonance imaging (fMRI) machine will be used to take images of the brain. An standard EKG (compatible with the fMRI machine) will be used to take measurements of cardiac vagal control.
16113381|NCT02062840|Other|Questionnaires|Weekly questionnaires to assess changes in depression, mood, perceptions of self and quality of life will be administered.
16113382|NCT02062827|Biological|M032 (NSC 733972)|A single dose of HSV-1 (M032) infused through catheters into region(s) of tumor defined by MRI
16113383|NCT02062801|Drug|Ephedrine|Patients received additional doses of ephedrine 10mg IV to a maximum of 30mg if BP remained low (<90mmHg systolic) and/was associated with persistent fetal bradycardia or maternal symptoms of dizziness and nausea
16113384|NCT02062801|Drug|Placebo|Patients received normal saline (placebo) administered immediately after combined spinal epidural (CSE) placement
16113385|NCT02062788|Dietary Supplement|Oral rehydration solution|Preoperative day #1: able to drink Oral rehydration solution (ORS) freely On day of Surgery: Allowed administration until 2hrs prior to surgery. 8AM patients(the first patients to undergo surgery of the day) are recommended to administer ORS at 5:30AM
16113386|NCT02062775|Procedure|Use of self-fixating mesh for inguinal hernia repair|Parietex ProGrip will be used to repair inguinal hernia
16113387|NCT02062775|Procedure|Use of non-fixating mesh for inguinal hernia repair|Parietex Anatomic mesh will be used to repair inguinal hernias.
16113388|NCT02062775|Procedure|Absorbable tacks may be used in hernias >2cm|Patients randomized to the Parietex ProGrip study group will be further randomized to either receive absorbable tacks or no tacks if the hernia measures >2cm
16113389|NCT02062762|Behavioral|Online-MBSR|8 week mindfulness based stress reduction online
16113390|NCT02062762|Behavioral|Expressive Writing Online|Online distributed expressive writing intervention as active control
16113391|NCT02062749|Drug|Oxaliplatin|Starting dose of Oxaliplatin is 175 mg/m2 delivered by hyperthermic intraperitoneal chemotherapy over 90 minutes.
16113392|NCT02062710|Drug|diphenhydramine/phenylephrine/cocoa; dextromethorophan; placebo|diphenhydramine 25 mg and phenylephrine 10 mg; dextromethorphan 30 mg; placebo.
16113393|NCT02062710|Drug|diphenhydramine/phenylephrine/cocoa; placebo; dextromethorphan|diphenhydramine 25 mg and phenylephrine 10 mg; placebo; dextromethorphan 30 mg.
16113394|NCT02062710|Drug|dextromethorphan; diphenhydramine/phenylephrine/cocoa; placebo|dextromethorphan 30 mg; diphenhydramine 25 mg and phenylephrine 10 mg; placebo
16113395|NCT02062710|Drug|dextromethorophan; placebo; diphenhydramine/phenylephrine/cocoa|dextromethorphan 30 mg; placebo; diphenhydramine 25 mg and phenylephrine 10 mg
16113396|NCT02062710|Drug|placebo; diphenhydramine/phenylephrine/cocoa; dextromethorphan|placebo; diphenhydramine 25 mg and phenylephrine 10 mg; dextromethorphan 30 mg
16113397|NCT02062710|Drug|placebo; dextromethorphan; diphenhydramine/phenylephrine/cocoa|placebo; dextromethorphan 30 mg; diphenhydramine 25 mg and phenylephrine 10 mg
16113398|NCT02062697|Procedure|Lavage of the Cavum uteri and proximal fallopian tubes|
16113399|NCT02062697|Procedure|Liquid-PAP smear|
16113400|NCT02062684|Drug|Blisibimod|
16113401|NCT02062684|Drug|Placebo|
16113402|NCT02062671|Procedure|renal denervation|
16113403|NCT02062658|Drug|Ketamine|0.5mg/kg IV
16113404|NCT02062658|Behavioral|Exposure and Response Prevention|A type of Cognitive Behavioral Therapy called Exposure and Response Prevention.
16113405|NCT02062645|Drug|amlodipine/valsartan|Fixed combination of amlodipine and valsartan in tablet; 5/160/mg, 10/160 mg
16113409|NCT02062632|Other|Questionnaire Administration|Ancillary studies
16113410|NCT02062619|Behavioral|Computer-based behavioural word reading therapy|"Each patient participates in two blocks of reading training (one with real tDCS, one with sham tDCS). Different words will be trained in each training block.
~Each training block comprises 10 hours of reading therapy per week for four weeks (three 1-hour sessions/week at research site; 1-hour of training/day at home)"
16113411|NCT02062619|Other|Real tDCS|Real tDCS 20 minutes per session, three times per week
16113412|NCT02062619|Other|Sham tDCS|Sham tDCS, 20 minutes per session, 3 sessions per week
16113413|NCT02062606|Device|MESA Rail™ Deformity System|MESA Rail™ (cross-sectioned rod) with MESA pedicle screws compared to traditional rod use in the literature
16113414|NCT02062593|Procedure|Coronary angioplasty|Percutaneous coronary intervention with drug-eluting stents and modern techniques
16113415|NCT02062580|Biological|BCG|
16113416|NCT02062541|Other|Funct. assessment+fast rehabilitation|
16113417|NCT02062541|Other|Funct. assessment+usual rehabilitation|
16113418|NCT02062541|Other|usual assessment+fast rehabilitation|
16113419|NCT02062528|Dietary Supplement|omega-3 fatty acids|highly dosed in EPA
16113420|NCT02062528|Dietary Supplement|placebo|
16113421|NCT02062515|Drug|icotinib|Icotinib is administered orally 125 mg three times per day continuously for four weeks
16113422|NCT02062502|Biological|VARIVAX™ New Seed Process|Varicella virus vaccine live manufactured with a new seed process
16113423|NCT02062502|Biological|VARIVAX™ 2007 process|Varicella virus vaccine live manufactured with the 2007 process
16113424|NCT02062502|Biological|M-M-R II™|Measles, Mumps, and Rubella virus vaccine live
16113425|NCT02062489|Drug|Tamoxifen|20 mg(2#)/day, PO, daily
16113426|NCT02062489|Drug|Placebo|2#/day, PO, daily
16113427|NCT02062476|Dietary Supplement|Lactobacillus GG|
16113428|NCT02062463|Drug|Budesonide and formoterol fumarate dehydrate (BF) SPIROMAX|SPIROMAX (BF) Budesonide and formoterol fumarate dehydrate (160/4.5 and 320/9 mcg)
16113429|NCT02062463|Drug|SYMBICORT TURBOHALER budesonide and formoterol fumarate|SYMBICORT® TURBOHALER® (200/6 and 400/12 mcg)
16113430|NCT02062450|Device|Primary surgery with Dual Mobility Cup|Hip joint replacement with a hip prosthesis including a Dual Mobility cup to replace the acetabular component.
16113431|NCT02062450|Device|Revision surgery with Dual Mobility Cup|Hip joint replacement with a hip prosthesis including a Dual Mobility cup to replace the acetabular component.
16113432|NCT02062424|Other|DIPI|
16113433|NCT02062411|Behavioral|CBT only|Participants will learn 12 sessions including educational information about ADHD and skills in organization and plan, reducing distractibility, and adaptive thinking.
16113434|NCT02062411|Behavioral|CBT with booster sessions|Participants are provided with the same CBT programme and additional 3 booster sessions which summarize and extend the 3 main topics of the CBT programme in order to improve the skills practice ability.
16113435|NCT02062398|Device|The Reprieve System|BlueWind Medical neurostimulator for the treatment of neuropathic pain
16113436|NCT02062385|Biological|V260|V260 (RotaTeq™; live, oral, pentavalent rotavirus vaccine)
16113437|NCT02062385|Biological|Placebo to V260|Placebo control
16113438|NCT02062385|Biological|OPV|Oral poliovirus vaccine administered according to the standard of care
16113439|NCT02062385|Biological|DTaP|Diphtheria, Tetanus, Acellular Pertussis vaccine administered according to the standard of care
16113440|NCT02062372|Device|7 T MRI|Overview Technical DetailsField strength: 7 Tesla Bore size: 60 cm System length: 317,5 cm RF power: 7,5 kW / 8x1 kW Gradient strength: SC 72 Gradients (max. 70 mT/m @ 200 T/m/s) Helium Consumption: Zero Helium boil-off technology
16113441|NCT02062372|Procedure|Biopsy|During surgery patients will receive standard biopsies plus one study biopsy from a region of interest. The neuro-surgeon will determine the feasibility of the extra biopsy and the optimal biopsy tract. A screen capture from the neuronavigation system will be saved for each biopsy to relate the findings on 3T and 7T MRI to histopathology.
16113442|NCT02062359|Biological|Anti-NY ESO-1 T cell receptor (TCR) cluster of differentiation 62L (CD62L)+ cells|"Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-NY ESO-1 T cell receptor (TCR) CD62L+ cells and high dose aldesleukin.
~On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes."
16113443|NCT02062359|Drug|Aldesleukin|Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
16113444|NCT02062359|Drug|Cyclophosphamide|On days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
16113445|NCT02062359|Drug|Fludarabine|On days -5 to -1: Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
16113446|NCT02062346|Drug|BQ123|Intravenous infusion of BQ123 ( selective ETA antagonist )
16113447|NCT02062346|Drug|BQ123/788|or BQ123/788 (mixed ETA/B antagonists)
16113448|NCT02062346|Drug|Placebo|Intravenous infusion of saline
16113449|NCT02062333|Drug|Dexmedetomidine|1 mcg/kg dexmedetomidine is applied bolus and 0.2 mcg/kg/h dexmedetomidine is applied iv infusion
16113450|NCT02062333|Drug|esmolol|500 mcg/kg brevibloc is applied bolus and 100 mcg/kg/h iv infusion
16113451|NCT02062281|Biological|23-valent pneumococcal polysaccharide vaccine|Single 0.5ml 23-valent pneumococcal polysaccharide vaccine was administered intramuscularly (IM)
16113452|NCT02062281|Biological|trivalent influenza vaccine|Single 0.5ml trivalent influenza vaccine was administered IM
16113453|NCT02062281|Biological|23vPPV+TIV|Single 0.5 ml 23-valent pneumococcal polysaccharide vaccine (23vPPV) and a single 0.5 ml trivalent inactivated influenza vaccine (TIV) were administered IM, in one day.
16113454|NCT02062268|Behavioral|health education & law enforcement|
16113455|NCT02062255|Drug|Aspirin|
16113456|NCT02062255|Dietary Supplement|Omega 3 FFA|
16113540|NCT02061657|Drug|Misoprostol|25 patients undergoing myomectomy operation will receive two tablets of misoprostol (400 mcg) rectally two hours before the operation
16113541|NCT02061657|Drug|Placebo( for misoprostol)|Include 25 patients undergoing myomectomy operation will not receive misoprostol before the operation.
16113457|NCT02062242|Other|Transvaginal electrical stimulation|The current employed is biphasic and the stimulation parameters are: frequency of 50 Hz, pulse width of 200 microseconds, contraction time (Ton) of 5 seconds and relaxation time (Toff) of 10 seconds. The current intensity is defined according to the tolerance of patient and the total stimulation time is 20 minutes.
16113458|NCT02062242|Other|Palpation|The patient is positioned supine with the lower limbs bent and feet flat on the stretcher. The examiner will hold vaginal palpation and to request her the contraction of PFM. It will be requested 3 sets of 10 contractions with a rest period between contractions. There are two minutes a rest period between sets.
16113459|NCT02062242|Other|Palpation with posterior pelvic tilt|The patient is positioned supine with the lower limbs bent and feet flat on the stretcher. The examiner will hold vaginal palpation and to request her the contraction of PFM associated with posterior pelvic tilt and contraction of accessory muscles. It will be requested 3 sets of 10 contractions with a rest period between contractions. There are two minutes a rest period between sets.
16113460|NCT02062242|Other|Control|The patient receive verbal instructions related to the pelvic floor and its contraction.
16113461|NCT02062203|Drug|AKB-6548 (therapeutic dose)|Single oral dose of AKB-6548 at a therapeutic dose level
16113462|NCT02062203|Drug|AKB-6548 (supratherapeutic dose)|Single oral dose of AKB-6548 at a supratherapeutic dose level
16113463|NCT02062203|Drug|Placebo|Single oral dose of placebo
16113464|NCT02062203|Drug|Moxifloxacin|Single oral dose of 400 mg moxifloxacin
16113465|NCT02062190|Drug|resveratrol|"100mg 2x/day
~1 month"
16113466|NCT02062177|Drug|Propofol|70 patients (35 upper endoscopy - 35 colonoscopy) are sedated with propofol TCI (Target Controlled Infusion) pump (concentration 1.2-1.6 mcg/ml).
16113467|NCT02062177|Drug|Midazolam|70 patients (35 upper endoscopy - 35 colonoscopy) in group midazolam are sedated with midazolam 0.04 mg/Kg if aged < 70, 0.03 mg/Kg if aged > 70.
16113468|NCT02062164|Procedure|bariatric surgery|The intervention takes place in the clinical care setting. The decision for surgery is made by a multidisciplinary team, according to the international guidelines and the recommendations of the German working group on obesity (AGA, www.a.g.a.de). The choice of procedure is made on an individual basis taking into consideration patient inherent factors as well as the recommendations of the operating center. Operations are conducted at certified bariatric centers according to the policies of the German working group on bariatric surgery (CAADIP), and in the context of a structured preparation and follow-up program. The program is offered by a multidisciplinary team (pediatrician, endocrinologist, surgeon, dietician, psychologist/psychiatrist, social worker) and comprises preparation for and education about the surgery and expected lifestyle changes, as well as a structured, multidisciplinary follow-up plan. Subjects sign a contract agreeing to adhere to the recommended follow-up schedule.
16113469|NCT02062164|Other|conservative care|Subjects will be seen by a trained study physician every 6 months. Stuctured health assessments will be conducted, and individual treatment recommendations will be made based on the patients motivation and ability(e.g. inpatient obesity rehab, exercise, dietary or behavioral intervention etc.)
16113470|NCT02062151|Other|Acupuncture|Acupuncture
16113471|NCT02062138|Other|continuous passive motion (CPM)|standard-of-care therapy (control intervention); Patients receive three 30 minutes CPM applications (unilateral op-leg) each day from the second postoperative day until 1 day prior to discharge.
16113472|NCT02062138|Other|controlled active motion (CAM I)|Patients receive three 30 minutes CAM applications (unilateral op-leg) each day from the second postoperative day until 1 day prior to discharge.
16113473|NCT02062138|Other|controlled active motion (CAM II)|Patients receive three 30 minutes CAM applications (bilateral alternating) each day from the second postoperative day until 1 day prior to discharge.
16113474|NCT02062112|Other|Pattern of flavoring of bowel laxative|Unflavored bowel laxative versus entire bowel laxative flavored versus liberal flavoring as decided by patient
16113475|NCT02062099|Drug|[18F]DPA-714 PET/ [18F]AV-45 PET/neuropsychological assessment|
16113476|NCT02062086|Dietary Supplement|deuterated creatine 30 mg|Study participants will take a single oral dose of deuterated creatine 30 mg in capsule form
16113477|NCT02062073|Drug|Abametapir Lotion 0.74% w/w|
16113478|NCT02062073|Other|0.1% sodium lauryl sulfate|
16113479|NCT02062073|Other|saline 0.9%|
16113480|NCT02062073|Other|Vehicle Lotion|
16113481|NCT02062060|Drug|Abametapir Lotion 0.74% w/w|
16113482|NCT02062060|Drug|Vehicle Lotion|
16113483|NCT02062047|Procedure|FMSRP|FMSRP in a maximum of 24 hours.
16113484|NCT02062047|Drug|Chlorhexidine|Application and irrigation of chlorhexidine, rinsing chlorhexidine solution during 60 days
16113485|NCT02062047|Procedure|PMSRP|Scaling and root planing in 4-6 sessions in a maximum of 2 weeks
16113486|NCT02062047|Other|Placebo|Application and irrigation of placebo, rinsing placebo solution during 60 days
16113487|NCT02062034|Drug|Ubiquinone|400mg daily of oral ubiquinone for 24 weeks
16113488|NCT02062034|Drug|Combined antioxidant therapy|(1 mg copper, 20 mg zinc, 180 mg vitamin C, 30 mg vitamin E, 1 mg zeaxanthin, 4 mg astaxanthin, 10 mg lutein) daily of oral, all of them in one Tablet for 24 weeks
16113489|NCT02062034|Drug|Placebo|100 mg of oral placebo with identical appearance, form, size than ubiquinone and antioxidant combined therapy for 24 weeks
16113490|NCT02062021|Other|No intervention|
16113491|NCT02062008|Device|PET-MRI|PET-MRI with intravenous Gadolinium and FDG. The entire study will take approximately one hour.
16113492|NCT02061995|Drug|PREOB® Intravenous Infusion|Each patient will undergo a single intravenous administration of PREOB®.
16113493|NCT02061982|Dietary Supplement|Coffee consumption|Coffee is consumed before cognitive tests. One cup of instant coffee with 75 mg of caffeine or 0 mg caffeine and will be prepared with 150-200 mL of hot water.
16113494|NCT02061969|Drug|linagliptin|5mg linagliptin tablets
16113495|NCT02061969|Drug|insulin glargine|
16113542|NCT02061644|Other|Spinal anesthesia|Routine spinal anesthesia procedure will be made to the patients for surgical anesthesia.
16113543|NCT02061631|Drug|Cisplatin|Pharmaceutical form:solution Route of administration: intravenous
16113544|NCT02061631|Drug|DOCETAXEL XRP6976|Pharmaceutical form:solution Route of administration: intravenous
16113545|NCT02061631|Drug|Dexamethasone|Pharmaceutical form:tablet Route of administration: oral
16113496|NCT02061930|Procedure|single crowns supported by implants|The implant placement procedures were planned based on clinical and radiographic evaluation. During the surgeries, the mid-crestal incision and intra-crevicular incision were made following local articaine infiltration anesthesia. No releasing incisions were made. After full-thickness flaps were elevated labially and lingually to expose the alveolar ridge, the implants were placed according to the standard surgical procedures defined by the manufacturer. After a healing time of 10-16 weeks, implant-level impressions were taken. The porcelain (Ivoclar-Vivadent AG, Schaan, Lichtenstein) fused to noble metal crowns were fabricated. Abutment screws were torqued to 15 Ncm. Crowns were cemented with HY-bond Glassionomer Cement
16113497|NCT02061917|Other|Tobacco-Heating Cigarette|Smokers switched to a tobacco-heating cigarette for 24 weeks
16113498|NCT02061917|Other|Snus (Smokeless Tobacco)|Smokers switched to snus product for 24 weeks
16113499|NCT02061917|Other|Tobacco-Burning Cigarette|Smokers switched to a tobacco-burning cigarette for 24 weeks
16113500|NCT02061904|Radiation|DEXA: dual energy X-ray absorptiometry|Bone mineral density development measured with dual energy X-ray absorptiometry
16113501|NCT02061904|Other|Short Form Health Survey 12|questionnaire for general health monitoring
16113502|NCT02061904|Other|VAS-satisfaction|questionnaire for intervention satisfaction monitoring
16113503|NCT02061904|Other|VAS-pain|questionnaire for pain monitoring
16113504|NCT02061904|Other|Harris Hip Score|questionnaire for hip function monitoring
16113505|NCT02061891|Procedure|Invasive coronary evaluation (Deferred)|Invasive coronary angiography and revascularization (PCI/CABG)
16113506|NCT02061891|Procedure|Invasive coronary evaluation (Acute)|Invasive coronary angiography and revascularization (PCI/CABG)
16113507|NCT02061878|Drug|Bexarotene|Marketed product Targretin® soft gelatin capsule (75mg/capsule) is over-encapsulated in a size AA-el Swedish orange capsule. The subjects will be administered three (3) capsules of Targretin™ (75 mg/capsule) on a twice daily basis (450 mg/day) for five days.
16113508|NCT02061878|Drug|Placebo|The subjects will be administered three (3) capsules of Avicel PH on a twice daily basis (450 mg/day) for five days.
16113509|NCT02061865|Drug|REGN2176-3|
16113510|NCT02061852|Device|Simeox|
16113511|NCT02061852|Procedure|Physiotherapy|
16113512|NCT02061839|Other|Sunscream with visible light protection|
16113513|NCT02061839|Other|Sunscream|
16113514|NCT02061813|Drug|Abametapir Lotion 0.74% w/w|applied 0.2 mL topically under occlusive condition
16113515|NCT02061813|Drug|Sodium Lauryl Sulfate|Sodium Lauryl Sulfate is prepared as a 0.2% aqueous solution by the site for topical administration, and applied 21 times over consecutive days under occlusive conditions, will serve as a positive control.
16113516|NCT02061813|Drug|Saline 0.9%|A solution of 0.9% saline for topical administration, applied 21 times over consecutive days under occlusive conditions, will serve as a negative control
16113517|NCT02061813|Drug|Placebo|
16113518|NCT02061800|Device|CliniMACS CD34+ Reagent System|The CliniMACS® Reagent System (Miltenyi Biotec, Germany), is a semi-automated immunomagnetic cell selection medical device that is used in vitro to select and enrich specific cell populations in a closed, sterile environment. The system is comprised of a computer controlled medical device containing a permanent magnet, a closed-system sterile tubing set containing columns coated with a ferromagnetic matrix, and a magnetic cell specific labeling reagent.
16113519|NCT02061800|Drug|Thiotepa|Standard of care: Thiotepa should be diluted in normal saline (NS) (1-5 mg/ml) and infused over 2 hrs on Days -5, -4. IV fluids should be at maintenance rate (1500 ml/m2). It is recommended that total parental nutrition not being used during Thiotepa administration as amino acid infusions may interfere with Thiotepa metabolism.
16113520|NCT02061800|Drug|Cyclophosphamide|Standard of care: Cyclophosphamide (Cytoxan) should be infused over one hour. The drug can be diluted in dextrose water solvent (D5W), NS, or other solutions (250cc) to a maximum concentration of 20 mg/mL.
16113521|NCT02061800|Drug|Alemtuzumab|Standard of care: Each dose of alemtuzumab is to be diluted in D5W or NS (maximum concentration: 0.3 mg/mL) for IV infusion over two hours.
16113522|NCT02061800|Drug|Tacrolimus|Standard of care: Tacrolimus dosing will be 0.03mg/kg/24 hours as continuous IV infusion or 0.12 mg/kg/day po divided Q8-12 hr
16113523|NCT02061800|Drug|Melphalan|Standard of care: Melphalan 45mg/m2 (1.5 mg/kg IV for children <1 year of age or <10 kg) diluted in 0.9% NS to a concentration of 0.1- 0.45mg/ml, given IV over 30 minutes.
16113524|NCT02061800|Drug|Busulfan|Standard of care: Busulfan will be given IV in 0.9% sodium chloride or D5W to a final solution for infusion equal to 10 times the volume of diluent to Busulfex (to a concentration >0.5 mg/mL), through a central venous access device over 2 hours.
16113525|NCT02061800|Drug|Fludarabine|Standard of care: Fludarabine will be given IV in 50-100 ml of D5W or 0.9% sodium chloride, over 30 minutes.
16113526|NCT02061800|Drug|Methylprednisolone|Standard of care: Methylprednisolone will be give IV slow infusion over 15-30 minutes.
16113527|NCT02061774|Drug|Acetaminophen|1 gram of intravenous Acetaminophen
16113528|NCT02061774|Drug|Placebo comparator|placebo comparator .9% NaCl (sodium chloride) 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours
16113529|NCT02061761|Biological|BMS-986016|Specified Dose on Specified Days
16113530|NCT02061761|Biological|BMS-936558|Specified Dose on Specified Days
16113531|NCT02061748|Drug|Observational|Retrospective Chart Review
16113532|NCT02061722|Radiation|PET Imaging with [18F]MNI-659|"The radioligands [11C]raclopride and [18F]MNI-659 will be administered at doses less than 10 micrograms, i.e. within the micro dosing concept, and no pharmacological effects are expected.
~The injected radioactivity of [11C]raclopride will be 300 MBq/70 kg of body weight ± 10%.
~The injected radioactivity of [18F]MNI-659 will be 185 MBq/70 kg of body weight ± 10%."
16113533|NCT02061709|Biological|Ragweed-SPIRE|
16113534|NCT02061709|Biological|Placebo|
16113535|NCT02061696|Device|Vascular Access Device|AXERA 2 Access System with Reduced Manual Compression
16113536|NCT02061696|Procedure|Standard Manual Compression|Closure procedure by Manual Compression
16113537|NCT02061683|Drug|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN®) 1 drop in the affected eye(s) once daily as monotherapy or adjunctive therapy for 3 months.
16113538|NCT02061670|Biological|Ragweed-SPIRE|Intradermal injection
16113546|NCT02061631|Drug|Dexamethasone|Pharmaceutical form:solution Route of administration: intravenous
16113547|NCT02061618|Behavioral|Bollywood Dance Exercise|
16113548|NCT02061605|Device|Laser Tissue Welding Device|Laparoscopic partial nephrectomy will be robotically assisted using the second generation da Vinci® Surgical System. Once the tumor is resected with laparoscopic scissors with a margin of healthy tissue, the solder will be dripped onto the cut surface of the parenchyma. A laparoscopic rigid 5mm spot-size laser hand-piece will be passed through the 10-mm port. The diode laser will be then used to weld a thin layer of solder onto the cut parenchymal surface. The 60 Watt 810-nm diode laser will be set to deliver continuous energy. During soldering, the tip of the laparoscopic laser hand-piece will be maintained 1 to 2 cm from the renal surface to generate a spot size of approximately 5 mm. Each spot will be treated with the laser until the color of the solder changes from green to white. The renal pedicle clamp will be removed to allow renal blood supply to be restored and the surgical site inspected for evidence of bleeding for 10 minutes prior to completing the surgical procedure.
16113549|NCT02061592|Device|etafilcon A|
16113550|NCT02061592|Device|etafilcon A|
16113551|NCT02061579|Behavioral|Structured Group Exercise|The study intervention is a 6-month exercise program with structured group sessions conducted in a clinical setting. Group sessions include Aerobic Training and Combined Training. Once-Weekly participants will attend one Combined Training session while thrice-weekly participants will attend two Combined Training sessions and one Aerobic Training session per week. Participants in both groups will attend three exercise evaluations during the intervention period. Participants will also use provided logs to track their daily exercise activities outside of group sessions. Physical activity will be assessed by group session attendance, exercise resistance and intensity, and exercise frequency data collected from exercise logs, surveys, and evaluations.
16113552|NCT02061553|Behavioral|Motivation|Control condition in which participants receive a single session with education on the importance of self-confidence and motivation, followed by 8 weeks of daily SMS messages with self-selected motivational statements.
16113553|NCT02061553|Behavioral|Intention|Implementation intentions are created collaboratively by participants and therapists in a single 2-hour session that uses principles of brief BA (the planning of rewarding activities). BA-based implementation intentions will then be delivered daily by text for 8 weeks.
16113554|NCT02061553|Behavioral|BA-Tech|Participants undergo a total of 8 sessions with a therapist. During these sessions, participants learn about the principles of BA (the translation of important life values into the planning of rewarding activities that support those values). The participants' values are explored and an activity schedule is created collaboratively by participants and therapists based on those values. Reminders to complete the scheduled activities will then be delivered by text once the schedule is made. Participants in this arm will also be monitoring their daily activities (and rating them based on enjoyment and perceived achievement) using a cell phone application.
16113555|NCT02061540|Drug|LUM001|LUM001 oral dose
16113556|NCT02061527|Procedure|Reconstruction with ADM.|If the patient wishes to undergo immediate implant based reconstruction, and meets the selection criteria for entering the study, she is randomly selected to be treated according to Group A or Group B. Group A (no intervention) will be reconstructed with expander or anatomical gel implant without ADM, using complete muscle coverage. Group B (Intervention) will be reconstructed with expander or anatomical gel implant using partial muscle coverage in conjunction with ADM.
16113557|NCT02061527|Procedure|Skin or nipple sparing mastectomy|Mastectomy for invasive or pre-invasive breast cancer
16113558|NCT02061527|Procedure|Reconstruction with implant|Immediate breast reconstruction with implant
16113559|NCT02061527|Procedure|Total submuscular coverage|Implant based breast reconstruction with total submuscular coverage
16113560|NCT02061527|Procedure|Partial submuscular coverage|Implant based breast reconstruction with partial submuscular coverage
16113561|NCT02061514|Procedure|maintenance with desflurane|in patients allocated to the desflurane group, general anesthesia will be maintained with desflurane
16113562|NCT02061514|Procedure|maintenance with propofol|in patients allocated to the propofol group, general anesthesia will be maintained with propofol
16113563|NCT02061501|Other|Optometric therapy during 6 months|Optometric therapy during 6 months, once a week
16113564|NCT02061501|Other|Optometric therapy during 12 months|Optometric therapy once a week, during 12 months
16113565|NCT02061488|Other|open-loop night|During the open-loop night the patient is using his insulin pump as usual
16113566|NCT02061488|Other|closed-loop night|During the closed-loop night glucose values measured by the sensor are collected every 15 minutes. The data are entered into the SP-MPC controler that calculate the insulin dose to be delivered. A diabetologist validates the insulin dose before the infusion (manually bolus infusion)
16113567|NCT02061475|Drug|Lidocaine Patches|
16113568|NCT02061462|Procedure|EVLP-DCD Group|Events: application of an open lung protective ventilatory strategy (recruitment manoeuvre, low volume-low frequency ventilation-high PEEP) to the DCD donors; procurement of lungs and cold storage on ice; reconditioning/evaluation by EVLP to assess suitability for transplantation; cold storage on ice; transplantation. Endpoints of suitability: oxygenation, respiratory mechanics, pulmonary vascular resistance, chest X-ray, fibrobronchoscopy
16113569|NCT02061449|Drug|Romidepsin|
16113570|NCT02061449|Drug|Poly ICLC|
16113571|NCT02061449|Radiation|Focal lesional radiation|
16113572|NCT02061423|Biological|HER-2 pulsed Dendritic Cell Vaccine|Each dose will consist of between 1.0-2.0 x 10^7 cells and will be injected into 1-2 different normal groin lymph nodes or axillary nodes.
16113573|NCT02061410|Device|Neuromuscular Electrical Stimlation (NMES)|The intervention was performed with subjects seated on a regular chair (hip and knee angles maintained at approximately 908), 3 times/week for a period of 8 weeks. NMES parameters included: rectangular biphasic symmetric current, pulse duration of 400 ms and stimulation frequency of 80 Hz.
16113574|NCT02061397|Drug|Simvastatin|Eligible patients on sirolimus or everolimus will be assigned to receive 20 mg of simvastatin once daily for a period of two months. If tolerated, the dosage of simvastatin will be advanced to 40 mg once daily in months 3 and 4.
16113575|NCT02061397|Drug|Sirolimus Oral Product|Eligible patients on sirolimus will be assigned to receive 20 mg of simvastatin once daily for a period of two months. If tolerated, the dosage of simvastatin will be advanced to 40 mg once daily in months 3 and 4.
16113703|NCT02060409|Genetic|spliceosome|spliceosome mutations
16113576|NCT02061397|Drug|Everolimus Oral Product|Eligible patients on everolimus will be assigned to receive 20 mg of simvastatin once daily for a period of two months. If tolerated, the dosage of simvastatin will be advanced to 40 mg once daily in months 3 and 4.
16113577|NCT02061384|Drug|13-cis retinoic acid|Accutane is used for the treatment of severe acne
16113578|NCT02061384|Drug|Calcitriol|Calcitriol is a form of vitamin D given twice daily (BID)
16113579|NCT02061371|Other|virtual therapy|
16113580|NCT02061371|Other|conventional physiotherapy|
16113581|NCT02061358|Drug|UV-4B 3 mg|Oral solution, single dose
16113582|NCT02061358|Drug|UV-4B 10 mg|Oral solution, single dose
16113583|NCT02061358|Drug|UV-4B 30 mg|Oral solution, single dose
16113584|NCT02061358|Drug|UV-4B 90 mg|Oral solution, single dose
16113585|NCT02061358|Drug|UV-4B 180 mg|Oral solution, single dose
16113586|NCT02061358|Drug|UV-4B 360 mg|Oral solution, single dose
16113587|NCT02061358|Drug|UV-4B 720 mg|Oral solution, single dose
16113588|NCT02061358|Drug|UV-4B 1000 mg|Oral solution, single dose
16113589|NCT02061358|Drug|Placebo|Oral solution, single dose
16113590|NCT02061332|Biological|HER-2 Pulsed Dendritic cell Vaccine|6 weekly HER-2 pulsed dendritic cell vaccines will be administered to subjects in each of the 3 arms.
16113591|NCT02061319|Behavioral|Nordic Walking|Participants in the Nordic walking group will be provided with walking poles (GymstickTM Nordic Walking Poles, Gymstick International OY, Lahti, Finland) for the duration of the study. They will attend on-site exercise classes twice weekly for 12 weeks. The on-site exercise training classes will be one hour in length and include the following components: a 15 minute chair warm-up that excludes resistance exercises; 10-15 minutes of walking with Nordic walking poles for the first 3 weeks, progressing to 30 minutes of continuous walking with poles for the remaining 9 weeks; and 15 minutes of cool down exercises. Participants will be instructed to take the walking poles home and perform 200-400 minutes of Nordic walking per week for 12 weeks
16113592|NCT02061293|Drug|Psilocybin|
16113593|NCT02061293|Drug|Diphenhydramine|
16113594|NCT02061293|Behavioral|Motivational Enhancement and Taking Action (META)|Manualized psychosocial intervention based on motivational enhancement therapy, functional analysis, and implementation of a change plan.
16113595|NCT02061280|Drug|fluticasone/salmeterol 250/50 Dry Powder Inhaler|Participants will receive Advair Diskus 250/50 Dry Powder Inhaler, administered twice daily for 12 weeks after randomization
16113596|NCT02061280|Drug|fluticasone/salmeterol 100/50 Dry Powder Inhaler|Participants will receive Advair Diskus 100/50 Dry Powder Inhaler administered twice daily for 12 weeks after randomization
16113597|NCT02061280|Drug|fluticasone 100mcg Dry Powder Inhaler|Participants will receive Flovent Diskus 100mcg Dry Powder Inhaler administered twice daily for 12 weeks after randomization
16113598|NCT02061267|Dietary Supplement|Niacin|The subjects will receive a vitamin B3 supplement (2 g)
16113599|NCT02061267|Dietary Supplement|Saturated meal|Test meal with high-fat (containing 72% saturated fat, 22% carbohydrate, and 6% protein)
16113600|NCT02061267|Dietary Supplement|Monounsaturated meal|Test meal with high-fat (containing 72% monounsaturated fat, 22% carbohydrate, and 6% protein)
16113601|NCT02061267|Dietary Supplement|Polyunsaturated meal|Test meal with high-fat (containing 72% polyunsaturated omega-3 fat, 22% carbohydrate, and 6% protein)
16113602|NCT02061254|Device|Cutometer|3 measures by cutometer on each area: the mean value will be the final value
16113603|NCT02061254|Device|High resolution ultrasonography (echography)|Cutaneous echography on the 3 areas, in order to measure skin thickness and echogenicity Measures are blinded to cutometer (by a different investigator)
16113604|NCT02061254|Device|Elastography|10 measures on the 3 areas (central measures will be doubled) Measures will be performed blinded to cutometer
16113605|NCT02061254|Procedure|Skin biopsy|Skin biopsy of 3 mm in diameter, for 30 participants, to evaluate histological fibrosis
16113606|NCT02061241|Procedure|Pacing in vein at site of latest mechanical activation|Pacing in vein at site of latest mechanical activation
16113607|NCT02061241|Procedure|Pacing in other suitable vein|Pacing in other suitable vein
16113608|NCT02061228|Device|Pipelle de Cornier®|Women in the intervention group will undergo an endometrial biopsy on the 6th day of ovarian stimulation using a Pipelle de Cornier® (CCD International, Paris, France). This class I individually and sterile-packaged medical device, complies with Directive 93/42/European Economic Community (EEC) and is routinely used in our centre for endometrial sampling. It is comprised of a flexible disposable polypropylene suction cannula with an outer diameter of 3.1 mm and a 2.4 mm diameter opening on the distal end, on one side of the cannula. An inner plunger creates a vacuum essential for the blind endometrial biopsy. After the introduction of the Pipelle into the uterine cavity, it will be rotated 360 degrees and moved up and down four times after withdrawing the piston.
16113609|NCT02061215|Other|CMV viral load|
16113610|NCT02061202|Drug|Mometasone Furoate|inhaled cortico-steroid (ICS) with a dosage of 220mcg once daily for 16 weeks
16113611|NCT02061202|Drug|Placebo|placebo training inhaler with the same instructions as the experimental group.
16113612|NCT02061189|Other|Physical exercise in a swimming pool during 6 months|10 patients will undergo a training program of physical exercise in a swimming pool, 3 days per week during 6 months. Each session will last for 20 minutes.
16113613|NCT02061176|Procedure|Transanal Haemorrhoidal Dearterialization|
16113614|NCT02061176|Procedure|Open Haemorrhoidectomy|
16113615|NCT02061163|Device|Contrast Enhanced Ultrasound|Subjects with Crohn's disease will undergo contrast enhanced ultrasound imaging with shear wave elastography. Both CEUS and shear wave elastography will be performed using FDA approved ultrasound machines.
16113616|NCT02061163|Drug|Optison|Optison is a microbubble contrast agent (dye) that will be injected during the CEUS imaging. Optison is FDA-approved for use in heart ultrasounds but not approved for use in bowel ultrasounds. Its use in this study is considered investigational (off-label).
16113617|NCT02061137|Drug|fingolimod (FTY720)|0.5 or 0.25 mg fingolimod orally daily for each of 6 patients with rett syndrome for 12 months
16113618|NCT02061124|Drug|Sevelamer 1600 mg TID for 7 days|
16113619|NCT02061124|Drug|Placebo 1600 mg TID for 7 days|
16113620|NCT02061098|Dietary Supplement|Pomegranate extract-first dose-Group A|Group A will consume 1 daily capsule of pomegranate extract for 3 weeks
16113744|NCT02060110|Device|MADIT-CRT ICD ONLY ARM|
16113621|NCT02061098|Dietary Supplement|Placebo-first dose-Group B|Group B will consume 1 daily capsules of placebo for 3 weeks.
16113622|NCT02061098|Dietary Supplement|Pomegranate extract-first dose-Group B|After 3 weeks of washout, group B will consume 1 daily capsule of pomegranate extract for 3 weeks.
16113623|NCT02061098|Dietary Supplement|Placebo-first dose-Group A|After 3 weeks of washout, group A will consume 1 daily capsule of placebo for 3 weeks.
16113624|NCT02061098|Dietary Supplement|Pomegranate extract-second dose-Group A|After 3 weeks of washout, group A will consume 4 daily capsules of pomegranate extract for 3 weeks.
16113625|NCT02061098|Dietary Supplement|Placebo-second dose-Group B|After 3 weeks of washout, group B will consume 4 daily capsules of placebo for 3 weeks.
16113626|NCT02061098|Dietary Supplement|Pomegranate extract-second dose-Group B|After 3 weeks of washout, group B will consume 4 daily capsules of pomegranate extract for 3 weeks.
16113627|NCT02061098|Dietary Supplement|Placebo-second dose-Group A|After 3 weeks of washout, group A will consume 4 daily capsules of placebo for 3 weeks.
16113628|NCT02061085|Drug|Eribulina|
16113629|NCT02061072|Other|Population pharmacokinetic estimation|Pre-existing individual PK data will be used to derive population PK models. Sparse concentration time data, acquired via a website, will be used to estimate individual pharmacokinetic parameters
16113630|NCT02061059|Other|block 1|shoemaker 1 produces shoes according to standard methods, shoemaker 2 uses plantar pressure measurements
16113631|NCT02061059|Other|block 2|shoemaker 2 produces shoes according to standard methods, shoemaker 1 uses plantar pressure measurements
16113632|NCT02061059|Other|standard|patient wears shoes produced with standard method
16113633|NCT02061059|Other|with measurements|patient wears shoes produced with plantar pressure measurements
16113634|NCT02061046|Device|CPAP therapy|8 weeks of CPAP therapy
16113635|NCT02061020|Drug|Cannabis (THC) in cigarettes of 30mg, 10mg and placebo|"Smoked THC containing cigarettes. Randomly allocated dosage 30mg, 10mg et placebo.
~Both chronic and occasional cannabis consuming volunteers will be allocated to smoking a cigarette containing (1) no THC (placebo), (2) a joint containing 1% THC (10 mg THC, i.e. low-dose) and (3) a joint containing 3% (30 mg THC) mixed with 1 g tobacco.
~Each cigarette will be followed by 24 hours testing in laboratory conditions. Each period is separated by 7 days (3 testing periods over 3 weeks). Each volunteer will undergo performance testing (driving simulator and PVT) before administration of the substance (T0).
~Blood samples and repeat performance testing will be carried out at 1 hour, 2 hours, 4 hours, 6 hours, 8 hours, 12 hours and 24 hours."
16113636|NCT02061007|Drug|Pimonidazole hydrochloride (Hypoxyprobe™-1)|Prior to surgery, patients will be administered a single dose of 0.5 g/m^2 (approximately 13 mg/kg) of oral Hypoxyprobe™-1 (pimonidazole, HCl).
16113637|NCT02061007|Drug|Optional 18F-FMISO PET scan (18F-fluoromisonidazole)|All patients will be offered the opportunity to receive an additional 18F-FMISO-PET scan, until 18 such scans are administered.
16113638|NCT02061007|Procedure|Surgical Resection of Melanoma Metastases|Participants will undergo surgical resection of melanoma metastases within 16 - 24 hours of consuming oral pimonidazole. Pimonidazole staining will be done on formalin-fixed and paraffin-embedded (FFPE) tissues for pimonidazole analysis. All participants will be contacted 24-72 hours post-surgery to be assessed for any adverse events (AEs) related to surgery, pimonidazole consumption and 18F-FMISO (when applicable).
16113639|NCT02060994|Other|No intervention|No intervention
16113640|NCT02060981|Behavioral|Control|Control group patients will then be mailed an American Heart Association brochure regarding hypertension and a brief, 5-question, paper-based survey.
16113641|NCT02060981|Behavioral|Interview Only|Patients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension.
16113642|NCT02060981|Behavioral|Interview plus decision support tool|Patients will be asked to participate in an interview regarding their views on hypertension and taking medications to treat hypertension and to provide feedback regarding a new decision support tool for helping patients learn more about their medications.
16113643|NCT02060968|Device|Promus PREMIER|
16113644|NCT02060955|Biological|ALECSAT|The ALECSAT will be administered at week 4, 9, 14, 26 and week 46. Cells are re-suspended in a plasmalyte injection fluid up to a total volume of 20 ml. The 20 ml cell suspension will contain between 10 million and 1 billion cells. Each dose is supplied in a sterile 20 ml syringe and should be injected intravenously.
16113645|NCT02060955|Drug|Bevacizumab/Irinotecan|Patients allocated to the Bevacizumab/Irinotecan (control group) will receive treatment according to standard praxis, i.e. up to 16 treatment cycles with 4 weeks duration. Each cycle consist of 2 dosing days; day 1 and day 15 in the cycle.
16113646|NCT02060929|Drug|Esketamine|Participants will self administer 1 spray of esketamine solution using a intranasal device with a nasal guide in Treatment A regimen and without nasal guide inTreatment B regimen at time 0 and repeated twice every 5 minutes (total dose: 84 mg).
16113647|NCT02060916|Drug|PAZ320|Single-center pilot study, open label dose escalation design
16113648|NCT02060903|Drug|Abametapir Lotion 0.74% w/w|Abametapir Lotion 0.74% was dispensed to subjects on Day 0 for self-administration at home on the same day.
16113649|NCT02060903|Drug|Vehicle Lotion|Vehicle Lotion was dispensed to subjects on Day 0 for self-administration at home on the same day.
16113650|NCT02060890|Other|specialized tumor board recommendation|feasibility of a specialized tumor board to come up with treatment recommendations no later than 35 days from surgery.
16113651|NCT02060877|Other|observational study: use of patient questionnaires|observational study, there is no study intervention, only patient questionnaires
16113652|NCT02060864|Dietary Supplement|AN-PEP|Two pills are consumed in the morning with a breakfast
16113653|NCT02060864|Dietary Supplement|Placebo|
16113654|NCT02060851|Other|standard PN|Group 1: a control group who received standard PN
16113655|NCT02060851|Drug|Vifor|iron sucrose, 200 μg/kg per day, was given everyday with PN,
16113656|NCT02060851|Drug|Vifor and EPO|EPO, 400U/kg, was given twice a week (Monday and Friday). IS, 200 μg/kg per day, was given everyday with PN, and the dose was continued until 2 weeks after birth
16113657|NCT02060838|Procedure|Acute normovolemic hemodilution (ANH)|Blood is drawn from our patients pre-bypass after obtaining the arterial line and administered back to the patient after separation from cardiopulmonary bypass (CPB) and reversal of heparin with protamine.
16113658|NCT02060825|Device|Regional saturation monitor|
16113659|NCT02060812|Procedure|Group I, SSNB & ANB|Suprascapular nerve block (SSNB) and axillary nerve block(ANB) were performed by one anesthesiologist under sono-guidance. 23 gauge spinal needle was used. SSNB was done at first and the entry site was the mid point between an anterolateral angle of acromion and medial end of scapular spine. With the linear probe, the suprascapular notch was identified and the block was performed penetrating the transverse scapular ligament because the scapular nerve and artery were located at the suprascapular notch. Just after the SSNB, ANB was performed and the entry site was the point 1.5 cm medial and 2cm inferior to posterolateral angle of acromion. With the linear probe, posterior circumflex artery was identified and the block was done at just above the artery.
16113660|NCT02060812|Procedure|Group II, SSNB alone|This is same as the Group I, SSNB & ANB, but ANB was performed with placebo(10mL normal saline).
16113661|NCT02060786|Drug|generic clopidogrel (Plavitor® )|
16113662|NCT02060786|Drug|original clopidogrel (Plavix® )|
16113663|NCT02060747|Behavioral|Coordinator-based post fracture program|
16113664|NCT02060734|Procedure|Lidocaine|Lidocaine injection 3-5 points in experimental group( using 25 gauge, 40mm long needle, pre-filled with 1% lidocaine inserting into the site of the trigger point).
16113665|NCT02060734|Other|Saline|The control group will receive a 25 gauge, 40mm long needle, pre-filled with saline inserting to subcutis.
16113667|NCT02060708|Device|HD-tDCS|HD-tDCS non-invasive brain stimulation using this same device (Soterix) has been designated a 'non-significant risk' by the US FDA.
16113668|NCT02060682|Device|Navvus Catheter FFR|Navvus Catheter provides Fractional Flow Reserve (FFR) measurement for each lesion identified according to standard of care of the center and the Instructions for Use (IFU).
16113669|NCT02060669|Drug|Xeloda|Xeloda
16113670|NCT02060656|Drug|Gemcitabine|1000mg/m2 IV D1, D8, D15 every 28 days
16113671|NCT02060656|Drug|Methylprednisolone|1000mg/m2 IV or PO D1-5 every 28 days
16113672|NCT02060656|Drug|Rituximab|375mg/m2 IV D1, D15 every 28 days
16113673|NCT02060656|Drug|Cisplatin|100mg/m2 IV D15 every 28 days
16113674|NCT02060656|Drug|Lenalidomide|25mg PO D1-21 every 28 days
16113675|NCT02060630|Procedure|Open surgical revascularization|
16113676|NCT02060630|Device|Endovascular revascularization|A variety of FDA approved devices will be used within this treatment arm. The trial will submit a proof-of-concept IDE application to the FDA to cover all devices.
16113677|NCT02060617|Behavioral|Patient Education|All subjects will receive education that back pain is common but rarely harmful in nature, that pain does not necessarily mean that there is structural damage to their back, and that they should try to remain as active as they are able within the limits of their pain. In addition, individualized education regarding posture, body mechanics, sleeping positions, or other concerns of the patient will be provided on a pragmatic basis as deemed appropriate by the treating clinician.
16113678|NCT02060617|Procedure|Manual therapy of the thoracolumbosacral spine and hips|Thrust and/or non-thrust manipulation and soft tissue mobilization as determined by mobility impairments identified on clinical examination.
16113679|NCT02060617|Procedure|Motor control exercises|Motor control exercises as determined by motor control impairments identified on clinical examination.
16113680|NCT02060617|Procedure|Treatment-Based Classification intervention|Lumbopelvic manipulation and range of motion exercise, spinal stabilization exercises, direction specific exercises, and/or traction will be applied as determined by the Treatment-Based Classification (TBC) Algorithm.
16113681|NCT02060604|Drug|Ketorolac + Ranibizumab|3 monthly ranibizumab, then as needed Ketorolac TID
16113682|NCT02060604|Drug|Ranibizumab|3 monthly ranibizumab, then as needed
16113683|NCT02060591|Drug|Exparel|
16113684|NCT02060591|Drug|Marcaine|
16113685|NCT02060578|Other|Questionnaire and interview|Questionnaire completed by the parents Interview with the parents and the psychologist (University Rennes 2)
16113686|NCT02060552|Drug|Diacerein|oral administration of IL-1βinhibitory
16113687|NCT02060552|Drug|Colchicine|"Colchicine is a toxic natural product and secondary metabolite, originally extracted from plants of the genus Colchicum (autumn crocus, Colchicum autumnale, also known as meadow saffron). It was used originally to treat rheumatic complaints, especially gout as the positive control"
16113688|NCT02060552|Drug|Febuxostat|A urate lowering drug, an inhibitor of xanthine oxidase that is indicated for use in the treatment of hyperuricemia and gout
16113689|NCT02060539|Device|Biofinity XR|
16113690|NCT02060526|Drug|Recombinant human heparan N-sulfatase [rhHNS]|Recombinant human heparan N-sulfatase [rhHNS]
16113691|NCT02060500|Procedure|Cardiaplication|
16113692|NCT02060487|Drug|sildenafil citrate|sildenafil citrate (PDE-5 inhibitor) 5 mg tablet TID until study treatment discontinued or end of study
16113693|NCT02060487|Drug|sildenafil citrate|sildenafil citrate (PDE-5 inhibitor) 20 mg tablet TID until study treatment discontinued or end of study
16113694|NCT02060487|Drug|sildenafil citrate|sildenafil citrate (PDE-5 inhibitor) 80 mg tablet TID until study treatment discontinued or end of study
16113695|NCT02060474|Drug|Triac|Triac is a naturally occuring T3 metabolite with similar bioactivity and receptor binding profile.
16113696|NCT02060461|Device|FS200 femtosecond laser LASIK|
16113697|NCT02060461|Device|IntraLase femtosecond laser LASIK|
16113698|NCT02060448|Behavioral|Emotion awareness training|Four weekly individual treatment sessions focused on increasing awareness of one's emotions.
16113699|NCT02060448|Behavioral|Cognitive reappraisal|Four weekly individual treatment sessions focused on thinking about stimuli in a way that diminishes one's emotions.
16113700|NCT02060435|Other|EBER|EBV RNA was detected by an in situ hybridization (ISH) technique using the EBV ISH kit (Leica Microsystems, Bannockburn, IL, USA).
16113701|NCT02060422|Behavioral|Mindfulness-based therapy|Mindfulness-based therapy is a four biweekly two-and-a-half-hour psychotherapy tailored for patients with drug-resistant epilepsy. The aims of this therapy are to introduce and practice mindfulness-based stress reduction techniques in coping with drug-resistant epilepsy.
16113702|NCT02060422|Behavioral|Social support group|Social support group is an attention-placebo with the same contact hours (four bi-weekly two-and-a-half-hour) as the experimental group, but without active treatment input. The aim of the social support group is to provide a supportive group atmosphere for patients with drug-resistant epilepsy.
16113704|NCT02060396|Drug|Acetylsalicylic acid|One tablet of Adiro 100 mg will be administered daily orally for 7 days.
16113705|NCT02060383|Drug|Pasireotide s.c.|Administered to Cushing's disease participants.
16113706|NCT02060383|Drug|Sitagliptin|Taken for approximately 16 weeks during the core study phase or until the drug was found not to be effective
16113707|NCT02060383|Drug|Liraglutide|Participant switched to liraglutide if sitagliptin was found not to be effective.
16113708|NCT02060383|Drug|Insulin|"Participant took insulin for 16 weeks. Insulin was also administered as rescue therapy in the incretin-based therapy arm if required.
~Insulin was administered to the BL-insulin group at the discretion of the Principal Investigator.
~Note: OAD and No OAD groups within the non-randomized arm did not take Insulin."
16113709|NCT02060383|Drug|Pasireotide LAR|Administered to Acromegaly participants.
16113710|NCT02060383|Drug|Metformin|"If previously normo-glycemic participants experienced increase in their fasting blood glucose and meeting the criteria for diabetes while on pasireotide, they started anti-diabetic treatment using metformin. If they continued to experience increase in their fasting blood glucose within the first 16 weeks, they were randomized in a 1:1 ratio to receive treatment with incretin based therapy or insulin for approximately 16 weeks. Metformin treatment was not required for the BL Insulin and OAD groups, within the non-randomized arm, but may have been prescribed at the discretion of the investigator.
~Note: No OAD group within the non-randomized arm did not take metformin."
16113711|NCT02060370|Drug|Sunitinib|"Starting dose: 50 mg by mouth daily given for 2 weeks on followed by 1 week off. 1 cycle is 6 weeks."
16113712|NCT02060370|Behavioral|Questionnaire|Questionnaire completion on Day 1 of Cycle 1, and on Day 35 of Cycles 2, 4, and 6.
16113713|NCT02060357|Device|Optical coherence tomography|
16113714|NCT02060318|Drug|Infliximab|The patients are included in the study when the decision to treat with Infliximab is already made. This study is observational, and all treatment and clinical follow-up are according to national guidelines.
16113715|NCT02060305|Drug|Bevacizumab intra-articular injection|Bevacizumab, 20~40mg, intra-articular injection every 28 days for 4 times
16113716|NCT02060279|Other|Lifestyle intervention and carotenoid supplements|2 week intervention partial hospitalization program followed by 8 bi-monthly sessions of a lifestyle intervention group run by a psychologist or health coach (research assistant). The entire intervention will last approximately 6 months. Children will participate in all aspects of the intervention including: dietary groups, life coaching, art and music therapy, school based learning, group therapy, physical activity, cooking, preparing meals, family therapy sessions, and yoga. The participants randomized to this study arm will also take Jarrow Formulas CaroteneAll® (5000 IU) supplement while at the intervention site for 2 weeks and then will continue to take the supplements for up to 6 months until their participation in the study is complete. Two capsules of supplement will be consumed daily with a meal with 6 oz. of water.
16113717|NCT02060279|Other|Lifestyle intervention and placebo|2 week intervention partial hospitalization program followed by 8 bi-monthly sessions of a lifestyle intervention group run by a psychologist or health coach (research assistant). The entire intervention will last approximately 6 months. Children will participate in all aspects of the intervention including: dietary groups, life coaching, art and music therapy, school based learning, group therapy, physical activity, cooking, preparing meals, family therapy sessions, and yoga. The participants randomized to this study arm will also take a gel-cap placebo while at the intervention site for 2 weeks and then will continue to take the placebo for up to 6 months until their participation in the study is complete. Two capsules of placebo will be consumed daily with a meal with 6 oz. of water.
16113718|NCT02060266|Drug|semaglutide|Subjects will receive a single dose subcutaneously (s.c., under the skin).
16113719|NCT02060253|Drug|ganetespib|Given IV
16113720|NCT02060253|Drug|paclitaxel|Given IV
16113721|NCT02060253|Biological|trastuzumab|Given IV
16113722|NCT02060253|Biological|pertuzumab|Given IV
16113723|NCT02060240|Behavioral|High Activity|The high activity group will undergo a 12 week ramped exercise protocol.
16113724|NCT02060227|Procedure|Open Latarjet procedure|
16113725|NCT02060227|Procedure|Arthroscopic Bankart repair|
16113726|NCT02060201|Drug|Saxagliptin|
16113727|NCT02060201|Drug|Dapagliflozin|
16113728|NCT02060201|Drug|Saxagliptin/Dapagliflozin FDC|
16113734|NCT02060175|Device|Cilotax drug-eluting stents implantation|
16113735|NCT02060175|Device|DESyne drug-eluting stents implantation|
16113736|NCT02060162|Other|Standard of care|routine standard of care per Ministry of Health protocol including blood draws and examinations.
16113737|NCT02060149|Drug|C/S plus minocycline.|Cefoperazone/ sulbactam 3.0g（intravenous infusion, q8h or q6h) combined with minocycline doxycycline 100mg (oral, q12h).
16113738|NCT02060149|Drug|nebulization with pH 7.4 solution|Patients will receive the nebulization with Sodium Bicarbonate of pH 7.4 (Each time the volume of aerosol solution is 5ml, q8h).
16113739|NCT02060149|Drug|nebulization with pH 7.8 solution|Patients will receive the nebulization with Sodium Bicarbonate of pH 7.8 (Each time the volume of aerosol solution is 5ml, q8h).
16113740|NCT02060149|Drug|No nebulization|No nebulization will be given to the patients.
16113741|NCT02060123|Behavioral|Qigong training|"a total of 103 hours over a period of 5.5 months, consisting of:
~Group learning and practice: a 2-hour qigong exercise training session will be provided by a qigong master twice a week for six consecutive weeks (24 hours),
~Weekly group follow-up: a 1-hour qigong exercise will be conducted with reinforcement of learning and remedial teaching by a qigong master once a week for four consecutive months (16 hours) after the group learning and practice, and
~Self-practice: participant will engage in qigong exercise for 30 minutes every day for the whole intervention period lasting 5.5 months (63 hours)."
16113742|NCT02060123|Other|Wait-list control- Health talks|Monthly health education talks unrelated to qigong will be provided starting from the point when the intervention group starts the qigong weekly follow-up.Once the intervention group has completed the qigong intervention program, the wait-list control group will receive the qigong exercise training.
16113743|NCT02060110|Device|Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study|
16113745|NCT02060097|Dietary Supplement|Cocoa flavanol beverage|
16113746|NCT02060097|Dietary Supplement|Placebo beverage|
16113747|NCT02060084|Drug|a control group|the same dose of luke warm water
16113748|NCT02060084|Drug|a probiotic-supplemented group|was orally administered starting from day 2 after birth, at a dose of 0.5g (the numbers of Long Bifidobacterium, Lactobacillus acidophilus and Enterococcus faecalis in live>0.5*107CFU), twice per day, for 2 weeks
16113749|NCT02060071|Other|Blood test|Blood test
16113750|NCT02060058|Drug|Stop trial intervention for boceprevir, PEG-IFN and RBV|"Stop trial intervention for patients with 32 week therapy (arm A): for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped.
~Stop trial intervention for patients with 48 weeks therapy (arm B): for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped.
~Stop trial intervention for for null responder or cirrhotic patients: (arm C) for all patients, if HCV RNA is more than 100 IU/ml at week 12 or HCV RNA is detectable at week 24, therapy will be stopped."
16113751|NCT02060045|Other|Bundle implementation|
16113752|NCT02060032|Drug|1.2% Atorvastatin local drug delivery|
16113753|NCT02060032|Drug|1.2% simvastatin local drug delivery|
16113754|NCT02060032|Drug|Placebo local drug delivery|
16113755|NCT02060019|Drug|administration of exforge 10/160mg for 3days. Next 7days administration of exforge 10/160mg and crestor 20mg.|
16113756|NCT02060006|Drug|Meloxicam 7.5mg daily for 8 weeks|Meloxicam 7.5mg daily for 8 weeks
16113757|NCT02059993|Device|continuous positive airway pressure|mean continuous positive airway pressure use was at least 4 hours per night;continuous positive airway pressure group received fixed-level continuous positive airway pressure titration using an automated pressure
16113758|NCT02059980|Behavioral|Response inhibition training|This is a computerized video game that offers 40 training levels, which aims to enhance the individual's response inhibition performance
16113759|NCT02059980|Behavioral|Placebo Control Training|This placebo control training looks very similar to the response inhibition training program in its appearance. However, it does not offer any practice related to response inhibition capabilities.
16113760|NCT02059967|Drug|Paclitaxel|Given IV
16113761|NCT02059967|Radiation|image-guided adaptive radiation therapy|Undergo IGART
16113762|NCT02059967|Drug|carboplatin|Given IV
16113763|NCT02059954|Procedure|Hysterectomy|
16113764|NCT02059928|Device|Intraosseous Device|
16113765|NCT02059915|Drug|Oxycodone|One capsule of 40 mg PF-00345439 Formulation X, single dose, under fed conditions
16113766|NCT02059915|Drug|Oxycodone|One capsule of 40 mg PF-00345439 Formulation K, single dose, under fed conditions
16113767|NCT02059915|Drug|Oxycodone|One capsule of 40 mg PF-00345439 Formulation X, single dose, under fasting conditions
16113768|NCT02059915|Drug|Oxycodone|One capsule of 40 mg PF-00345439 Formulation K, single dose, under fasting conditions
16113769|NCT02059902|Drug|Lidocaine|Lidocaine infusion runs for a total of 24 hours
16113770|NCT02059902|Other|Placebo|Normal saline runs for a total of 24 hours
16113771|NCT02059889|Device|diffusion-weighted magnetic resonance imaging|Undergo diffusion-weighted MRI
16113772|NCT02059889|Device|4-dimensional computed tomography|Undergo 4D CT
16113773|NCT02059889|Radiation|fludeoxyglucose F 18|Undergo FDG-PET
16113774|NCT02059889|Device|FDG-PET|Undergo FDG-PET
16113775|NCT02059876|Drug|carboplatin and paclitaxel and or without trastuzumab|dose-dense(biweekly) carboplatin and paclitaxel and or without trastuzumab as neoadjuvant treatment in early breast cancer
16113776|NCT02059863|Behavioral|SPRING|SPRING package: Home visits by community based agents carried out from pregnancy to 2 years of age to encourage key behaviours to promote child growth, survival and development together with regular supervision
16113777|NCT02059850|Biological|Autologous NY-ESO-1-specific CD8-positive T Lymphocytes|Given IV
16113778|NCT02059850|Drug|Cyclophosphamide|Given IV
16113779|NCT02059850|Other|Laboratory Biomarker Analysis|Correlative studies
16113780|NCT02059837|Procedure|recurrent pterygium excision and following grafting|The excision of recurrent pterygial tissue and autograft of conjunctiva was done.
16113781|NCT02059824|Device|Aesthesiometer|"The eyelid sensation will be tested on every third by applying the tip of the aesthesiometer filament perpendicular to the eyelid skin and tarsal plate until the filament bent slightly. The filament length will be set at 6 cm (longest length) and applied to the test site 3 times. This process will be repeated 3 times and if the patient verbally responded to the 3rd touch, the number 6 will be recorder.
~If the patient responded less than 3 of the 3 times, the filament will be shortened by 0.5 cm and the test will be repeated. This process will be continued by shortening the filament 0.5 cm each time, until the patient feels the filament touch 3 of 3 times. This filament length number will be recorded as the touch reading for that time period."
16113782|NCT02059811|Other|DASH Diet|The DASH diet is a nutritional intervention that is low in cholesterol and saturated fat and emphasizes high intake of the following: fruits, vegetables, low-fat dairy products, whole grains, fiber, and protein derived mostly from plant sources.
16113783|NCT02059811|Other|Control Diet|The control diet, which is a diet typical of most Americans, is relatively high in total and saturated fat and cholesterol, and low in servings of fruits, vegetables and low fat dairy products.
16113784|NCT02059785|Drug|Pinocembrin for Injection|
16113785|NCT02059772|Drug|ranibizumab|
16113786|NCT02059772|Procedure|micropulse diode laser|
16113787|NCT02059759|Drug|Placebo|Patients in this arm will receive sub-cutaneous injections of placebo (same vehicle as for experimental arms, and same volume) for 5 consecutive days at the beginning of three consecutive months (a total of 15 injections, 5 per month for 3 months).
16113788|NCT02059759|Drug|1.0 MIU IL-2 per day|Patients in this arm will receive sub-cutaneous injections corresponding to 1.0 MIU of IL-2 per injection for 5 consecutive days at the beginning of three consecutive months (a total of 15 injections, 5 per month for 3 months).
16113789|NCT02059759|Drug|2.0 MIU IL-2 per day|Patients in this arm will receive sub-cutaneous injections corresponding to 2.0 MIU of IL-2 per injection for 5 consecutive days at the beginning of three consecutive months (a total of 15 injections, 5 per month for 3 months).
16113844|NCT02059434|Drug|LAS190792 Dose 1 (Part 2)|
16113845|NCT02059434|Drug|LAS190792 Dose 2 (Part 2)|
16113790|NCT02059746|Other|Questionnaires sent by mail|The questionnaires necessary for the study are mailed to patients at 3 and 12 months post-partum.
16113791|NCT02059733|Drug|18F-DTBZ|"During this study, subjects will receive a single i.v. administration of approximately 10 mCi 18F-DTBZ immediately prior to imaging.
~The proposed dose for this study is based on our phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG."
16113792|NCT02059720|Procedure|HSCT|Patients randomly assigned in to either of groups will receive either autologous SCT or haplo-SCT after CR1 is achieved.
16113793|NCT02059707|Device|LARIAT RS Suture Delivery Device|LARIAT RS Suture Delivery Device
16113794|NCT02059694|Drug|Hyaluronidase|
16113795|NCT02059694|Other|2 mL of lidocaine 2% with epinephrine 1:100,000 without rHuPH20|
16113796|NCT02059681|Other|Autologous bone marrow derived-CD133+ cells|Cell therapy
16113797|NCT02059668|Biological|Biomarker analyses head & neck cancer tissue, blood specimen|For biomarker analyses, tumor tissues from previous biopsies and surgery and blood specimens taken during treatment at the treating institution will be used.
16113798|NCT02059655|Drug|Bimatoprost|
16113799|NCT02059655|Drug|Eye drop solution|Artificial tear drops
16113800|NCT02059642|Drug|MG01CI (1400 mg)|MG01CI (Metadoxine Immediate-release/Slow-release, Bilayer Caplet) 1400 mg administered orally once daily
16113801|NCT02059642|Drug|placebo|Placebo 1400 mg administered orally once daily
16113802|NCT02059629|Device|Eluna pacemaker family|"New pacemaker generation with new functions, like wandless RF telemetry SafeSync"
16113803|NCT02059629|Device|Sentus BP lead|over-the-wire (OTW), bipolar (BP), L-shaped (L), 4.8 French left ventricular lead
16113804|NCT02059616|Drug|Amlodipine 5mg|Daily oral administration for 8 weeks
16113805|NCT02059616|Drug|Amlodipine 10mg|Daily oral administration for 8 weeks
16113806|NCT02059616|Drug|Candesartan Cilexetil 8mg|Daily oral administration for 8 weeks
16113807|NCT02059616|Drug|Candesartan cilexetil 16mg|Daily oral administration for 8 weeks
16113808|NCT02059603|Procedure|Electroacupuncture|
16113809|NCT02059603|Procedure|Fast-track program|
16113810|NCT02059590|Drug|Pyridinylmethyl-14C-labeled isavuconazonium sulfate|Intravenous
16113811|NCT02059577|Dietary Supplement|Nutritional and Dietary Interventions|Day 0: Vitamin/Mineral supplementation begins. Day 30: Essential Fatty Acid supplementation begins. Day 60: Epsom Salt baths begin (2x/week) Day 90: Carnitine supplementation begins Day 180 Digestive Enzyme supplementation begins; Day 210: Healthy, casein-free, gluten-free diet is begun.
16113812|NCT02059564|Drug|HM11260C|doses of 6 mg, 16 mg
16113813|NCT02059564|Drug|Placebo|Normal saline solution
16113814|NCT02059564|Drug|Victoza|doses of 1.8 mg
16113815|NCT02059551|Procedure|MRI combined with venous ultrasonography of the legs|In case of positive D-dimer testing or in patients with a high probability of PE, MRI and a venous ultrasonography of the legs are done.MRI protocol includes 2 sequences: 1-Unenhanced steady-state-free precession sequences (SSFP) are acquired first without ECG-gating or breath-holding in the axial plane in the multiphase cine mode, with 6 phases per location.The acquisition is repeated to cover 2-3 of the thorax, from the roof of the aorta to the diaphragm. 2- A pulmonary gradient recalled echo (GRE) sequence is performed in the axial plane.The acquisition is triggered to start when contrast enhancement occurred in the right ventricle.Two acquisitions are necessary to cover the anatomy. For each acquisition, 0.15 mL kg-1 body weight of DOTAREM Gadolinium is injected at a rate of 3 mL s-1 followed by an injection of 15 mL of normal saline at 3 mL s-1.Venous ultrasonography of the legs: the examination consists of a real-time B-mode examination of the common femoral and popliteal veins.
16113816|NCT02059538|Other|Adipose tissue biopsies (omental and subcutaneous) liver|
16113817|NCT02059538|Radiation|CT-scan|
16113818|NCT02059538|Other|Stools sampling|
16113819|NCT02059538|Other|DNA sampling|
16113820|NCT02059538|Other|Blood sampling|
16113821|NCT02059538|Other|Urine sampling|
16113822|NCT02059538|Radiation|Dual energy X-ray absorptiometry-scan (DEXA-scan)|
16113823|NCT02059512|Procedure|Group 1|Coronary artery bypass grafting with intramyocardial administration of autologous bone marrow mononuclear cells 0.2 ml - 10 injection in the zone of blood supply LAD.
16113824|NCT02059512|Procedure|Group 0|Coronary artery bypass grafting with intramyocardial administration of 0.9 % NaCl (sodium chloride) 0.2 ml - 10 injection in the zone of blood supply LAD.
16113825|NCT02059512|Procedure|Group 2|Coronary artery bypass grafting with intramyocardial and intracoronary administration of autologous bone marrow mononuclear cells intramyocardial administration 0.2 ml - 10 injection in the zone of blood supply LAD.
16113826|NCT02059499|Drug|imiquimod|Given intra-anally
16113827|NCT02059499|Drug|fluorouracil|Given intra-anally
16113828|NCT02059499|Other|questionnaire administration|Ancillary studies
16113829|NCT02059499|Other|laboratory biomarker analysis|Correlative studies
16113830|NCT02059486|Behavioral|Teen Choice|The curriculum provides sexual education on topics such as anatomy, puberty, sexually transmitted infections, and contraceptive methods (including abstinence). It also covers topics such as gender and sex roles, sexual orientation, decision making and conflict resolution, adult-teen relationships, rape and sexual assault, and coping with stress.
16113831|NCT02059473|Procedure|Rotator cuff repair|Physiotherapy & Surgery
16113832|NCT02059473|Procedure|Physiotherapy|
16113833|NCT02059460|Drug|Terlipressin|Terlipressin (Glypressin®) will be started by continuous infusion at a dose of 1-4 µg/kg/h till day 4 postoperatively
16113834|NCT02059460|Drug|placebo|
16113835|NCT02059447|Other|No treatment waiting period|All subjects undergo a no treatment waiting period before being randomly allocated to either Mindfulness Based Cognitive Therapy or Relaxation Therapy
16113836|NCT02059447|Behavioral|Mindfulness Based Cognitive Therapy|
16113837|NCT02059447|Behavioral|Relaxation Therapy|
16113838|NCT02059434|Drug|LAS190792 Dose 1|
16113839|NCT02059434|Drug|LAS190792 Dose 2|
16113840|NCT02059434|Drug|LAS190792 Dose 3|
16113841|NCT02059434|Drug|LAS190792 Dose 4|
16113842|NCT02059434|Drug|LAS190792 Dose 5|
16113843|NCT02059434|Drug|LAS190792 Dose 6|
16113847|NCT02059434|Drug|Indacaterol 150 μg|
16113848|NCT02059434|Drug|Placebo|
16113849|NCT02059421|Behavioral|Cognitive Behavioral Therapy for Insomnia (CBT-I)|"- Therapy session administered by a clinical psychologist using web-based video conferencing software.
~Therapy sessions will include:
~Sleep restriction therapy
~Stimulus control instructions
~Sleep hygiene education"
16113850|NCT02059421|Other|Johrei therapy|"Therapy will be administered by a senior Johrei administrator at the University of Arizona or the patient's residence.
~Therapy sessions will consist of 3 sessions per week lasting 30 minutes each.
~Therapist will wash his hands and and pray for 1 minute while facing the subject at a distance.
~Therapy will be administered without physical contact.
~During therapy the administrator will sit adjacent to the patient and channel energy from his palm towards the patient."
16113851|NCT02059408|Other|Screen-Educate|Education program to improve blood pressure control among hypertensive non-diabetic persons. The Screen and Educate arm will recommend using creatinine, cystatin C and albuminuria for screening and risk stratification, followed by guideline-concordant CKD management appropriate for CKD stage. Recommendations are sent to the primary care provider via an electronic note.
16113852|NCT02059408|Other|Screen-Educate and Intensify Treatment|This arm adds option of a pharmacist. PCPs randomized to this arm will have the additional option to refer their higher-risk patients to a clinical pharmacist-led CKD management program with education. A primary care clinical pharmacist will schedule a series of appointments with patients found to have confirmed higher-risk CKD (defined as eGFRcreat-cys <45, or eGFR 45-59 and ACR ≥ 30 mg/g). The pharmacist will follow treatment algorithms recommended by the 2012 KDIGO international CKD guidelines, and designed by a team of internists and nephrologists.
16113853|NCT02059395|Other|Mastery based learning|Participants are allowed to follow the course content at their own speed
16113854|NCT02059395|Other|Time based learning|Participants follow the traditional Canadian Heart and Stroke Foundation Heartsaver Course according to the official course layout
16113855|NCT02059382|Behavioral|ChiRunning training|
16113856|NCT02059382|Behavioral|unblinded accelerometer|
16113857|NCT02059382|Behavioral|participation in online social network|
16113858|NCT02059382|Behavioral|participation in study website|
16113859|NCT02059382|Behavioral|Technology support for behavior change|
16113860|NCT02059369|Procedure|PVI+CFAE+DCC|pulmonary vein Isolation (PVI), CFAE for substrate modification and direct current cardioversion (DCC) if AF persists
16113861|NCT02059369|Procedure|PVI, CFAE, anterior and roof line, DCC|PVI, CFAE ablation. If AF persists linear lesions (anterior and roof line), cardioversion if AF persists
16113862|NCT02059330|Drug|Palbociclib 75mg|In Period 1, Japanese subjects will receive a single oral 75mg dose of palbociclib with food. Serial PK assessments will be collected over the next 120 hours.
16113863|NCT02059330|Drug|Palbociclib 125mg|In Period 2, Japanese subjects will receive a single oral 125mg dose of palbociclib with food. Serial PK assessments will be collected over the next 120 hours.
16113864|NCT02059330|Drug|Palbociclib 100mg|In Period 3, Japanese subjects will receive a single oral 100mg dose of palbociclib with food. Serial PK assessments will be collected over the next 120 hours.
16113865|NCT02059330|Drug|Palbociclib|In Period 4, Japanese subjects will receive a single oral dose of palbociclib with food. Serial PK assessments will be collected over the next 120 hours. The amount of the dose will be determined based on an interim analysis of the PK data from Periods 1 and 2.
16113866|NCT02059330|Drug|Palbociclib 125mg|In Period 1, healthy non-Asian subjects will receive a single oral 125mg dose of palbociclib with food. Serial PK assessments will be collected over the next 120 hours.
16113867|NCT02059317|Other|Flexion-extension in the sagittal plane|The movement required is a flexion - extension where the subject touches a target (adapted to his/her morphology) with both index fingers: the target is positioned in front of the subject, inline with his/her outstretched arms and at knee height. This movement simulates a lifting task without weight. The movement is repeated 30 times with a return to the initial position at a frequency of 0.32Hz.
16113868|NCT02059317|Other|Rotation in a transverse plane|The movement required of the subject is a rotational movement where the subject alternately touches with his/her left and right hands two targets. The latter are positioned horizontally on either side of the subject at shoulder height and at arm's length. The movement is repeated 30 times at a frequency of 0.28 Hz.
16113869|NCT02059317|Other|Complex movement in three dimensions|The subject is required to successively touch 4 targets situated (i) at knee height to the left of the subject, (ii) at shoulder height to the right of the subject, (iii) at shoulder height to the left of the patient, and (iv) at knee height to the right of the patient. The movement is repeated 30 times at a frequency of 0.16 Hz.
16113870|NCT02059304|Device|Measurement of cervical length with embryo transfer catheter|
16113871|NCT02059291|Drug|Canakinumab|Canakinumab solution for subcutaneous injection in vial which contained 150mg/mL canakinumab in 1 mL solution.
16113872|NCT02059291|Drug|Placebo|Matching placebo to canakinumab solution for subcutaneous injection
16113873|NCT02059278|Drug|T-2345|T-2345 Ophthalmic Solution
16113874|NCT02059278|Drug|Xalatan|Xalatan (latanoprost 0.005% ophthalmic solution)
16113875|NCT02059265|Drug|Dasatinib|Given PO
16113876|NCT02059265|Other|Laboratory Biomarker Analysis|Correlative studies
16113877|NCT02059252|Device|SmartMatrix dermal replacement scaffold|SmartMatrix dermal replacement scaffold
16113878|NCT02059239|Drug|Bendamustine|Days - 24 and Day - 23 followed by a short break of 10 - 14 days.
16113879|NCT02059239|Drug|Carmustine|300 mg/m2 on Day -6
16113880|NCT02059239|Drug|Etoposide|100 mg/m2 on days -5 to -2
16113881|NCT02059239|Drug|Melphalan|140mg/m2 on Day -1
16113882|NCT02059239|Drug|Cytarabine|200 mg/m2 on days -5 to -2
16113883|NCT02059239|Drug|Alemtuzumab|20 mg/m2 days -6 to -2 for UNRELATED donors, and 20 mg/m2 days -4 to -2 for RELATED donors
16113884|NCT02059239|Biological|Autologous Stem Cell Transplantation|
16113885|NCT02059239|Biological|Allogeneic Stem Cell Transplantation|
16113886|NCT02059239|Drug|Rituximab|Only to be administered in subjects with B-cell malignancies. Dose is 375 mg/m2 on Days 1 and 8 post-transplant
16113887|NCT02059226|Behavioral|cognitive behavioural therapy|Internet-based CBT
16113888|NCT02059226|Other|Internet-based resource page|Static webpage
16113889|NCT02059213|Drug|Ibrance|
16113893|NCT02059200|Behavioral|Mindfulness Based Compassionate Living|The MBCL program consists of eight biweekly group sessions of 2.5 hours, in which the participants get formal meditation exercises, some theoretical information and participate in inquiry on the meditation exercises and homework assignments. Homework assignments are given after every session, consisting of formal and informal meditation exercises primarily and some diary instructions.
16113894|NCT02059187|Drug|MK-1293|MK-1293 (insulin glargine) 100 units/mL administered subcutaneously once daily for 24 weeks. Participants not taking insulin at study entry will initiate MK-1293 at 10 units daily. Participants taking insulin will initiate MK-1293 at an appropriate dose based on prior insulin dosing. After initiation, the dose will be titrated to the suggested target for fasting finger stick glucose. MK-1293 dosing once daily at times other than bedtime will be permitted for participants with a previously established dosing time.
16113895|NCT02059187|Drug|Lantus™|Lantus™ (insulin glargine [rDNA origin]) 100 units/mL administered subcutaneously once daily for 24 weeks. Participants not taking insulin at study entry will initiate Lantus™ at 10 units daily. Participants taking insulin will initiate Lantus™ at an appropriate dose based on prior insulin dosing. After initiation, the dose will be titrated to the suggested target for fasting finger stick glucose. Lantus™ dosing once daily at times other than bedtime will be permitted for participants with a previously established dosing time.
16113896|NCT02059187|Drug|Prandial insulin|Participants taking prandial insulin will continue their current prandial insulin regimen during the insulin glargine titration. After the insulin glargine titration phase, the prandial insulin may be adjusted if the investigator determines it to be necessary for glucose control.
16113897|NCT02059174|Drug|MK-1293|MK-1293 0.4 units/kg administered subcutaneously
16113898|NCT02059174|Drug|EU-Lantus™|EU-Lantus™ 0.4 units/kg administered subcutaneously
16113899|NCT02059174|Drug|Novolog™|Participants will receive an intravenous infusion of insulin aspart (Novolog™ or other rapid-acting insulin analog) for several hours prior to MK-1293 or EU-Lantus™ dosing in each dosing period to meet basal insulin requirements
16113900|NCT02059161|Drug|MK-1293|MK-1293 dosed subcutaneously once daily at bedtime for 52 weeks. Initial dose will be determined based on the participant's previous insulin therapy. Thereafter, the dose will be titrated to the suggested target for fasting fingerstick glucose levels. MK-1293 dosing once daily at times other than bedtime will be permitted for participants with a previously established dosing time.
16113901|NCT02059161|Drug|Lantus™|Lantus™ dosed subcutaneously once daily at bedtime for 52 weeks. Initial dose will be determined based on the participant's previous insulin therapy. Thereafter, the dose will be titrated to the suggested target for fasting fingerstick glucose levels. Lantus™ dosing once daily at times other than bedtime will be permitted for participants with a previously established dosing time.
16113902|NCT02059161|Drug|Prandial Insulin|Participants will continue their prandial insulin during the study.
16113903|NCT02059148|Drug|LY2835219|Administered orally.
16113904|NCT02059135|Biological|Recombinant human antithrombin (ATryn)|Atryn 250 mg loading dose over 15 minutes, immediately followed by continuous infusion of 2000 mg per 24 hours. Total daily dose is 2250 mg for the first day and 2000 mg on subsequent days
16113905|NCT02059135|Other|Normal Saline 0.9%|Placebo Comparator: Normal Saline 0.9%
16113906|NCT02059109|Procedure|Hands on Assembly of Belmont Rapid Infuser|Participants will work individually or in pairs to assemble the Belmont Rapid Infuser in addition to completing the traditional training methods.
16113907|NCT02059096|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|
16113908|NCT02059083|Behavioral|Heart rate variability biofeedback|
16113909|NCT02059083|Behavioral|CBT|
16113910|NCT02059070|Drug|Ropivacaine|Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery.
16113911|NCT02059070|Drug|Bupivacaine|Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery.
16113912|NCT02059057|Device|LVRC System|
16113913|NCT02059044|Other|ISTOP-ADE|Interactive Voice Response System + Pharmacist
16113914|NCT02059031|Drug|GSK1265744 Reference formulation|GSK1265744 (micronized) reference formulation is available as 30 mg tablet to be orally administered with 240 mL of water
16113915|NCT02059031|Drug|GSK1265744 New formulation 1|GSK1265744 (micronized) New formulation 1 is available as 30 mg tablet to be orally administered with 240 mL of water
16113916|NCT02059031|Drug|GSK1265744 New formulation 2|GSK1265744 (un-micronized) New formulation 2 is available as 30 mg tablet to be orally administered with 240 mL of water
16113917|NCT02059018|Drug|COX-inhibitor|Administration of 1 drop voltaren 45 minutes before recordings of diameter changes of retinal vessels are initiated
16113918|NCT02059018|Drug|Nitroglycerin|Oral administration of tablet nitroglycerin 0,5mg 5 minutes before recordings of diameter changes of retinal vessels are initiated
16113919|NCT02059018|Drug|COX-inhibitor + Nitroglycerin|Combination of COX-inhibitor and nitroglycerin interventions.
16113920|NCT02059005|Behavioral|Specialized Community Disease Management|Specialized Community Disease Management is 90-day program that employs specialized teams including a trained clinical social worker and a peer-specialist community health worker who provide evidence-based telephone continuing care, home visits, and focus on patients' substance use following hospital discharge.
16113921|NCT02059005|Behavioral|Treatment As Usual|Treatment as Usual is a 90-day, post-discharge program that consists of medical monitoring by nurses and community health workers who have no special training in working with substance use disorder patients, and does not address substance use.
16113922|NCT02058992|Drug|Ramelteon|Ramelteon 8 mg tablets
16113923|NCT02058979|Drug|BOLUS INFUSION (Ancef)|Bolus Infusion of antibiotics
16113924|NCT02058979|Drug|CONTINUOUS INFUSION (Ancef)|Continuous Infusion of ANCEF with infusion pump
16113925|NCT02058966|Drug|Entacapone|Entacapone 200 mg oral dose
16113926|NCT02058966|Drug|Methamphetamine|Methamphetamine 20 mg oral dose
16113927|NCT02058966|Drug|Placebo|capsules compounded to be of similar appearance to the active drugs
16113928|NCT02058953|Procedure|Craniotomy scheduled|Resection of affected brain tissue
16113929|NCT02058953|Procedure|Collection for non-craniotomy|CSF, Blood, biopsy
16113930|NCT02058940|Drug|Exenatide|50 ng/min IV for 30 minutes, then start 25 ng/min IV for a maximum duration of 48 hours
16113931|NCT02058927|Drug|Measles vaccine|measles revaccination administered at 12 months from start of ART
16113932|NCT02058914|Dietary Supplement|high fructose sweetened beverage|710 ml per day of a HF-sweetened beverage
16113933|NCT02058914|Dietary Supplement|High Glucose sweetened beverage|HG-sweetened beverage
16113934|NCT02058901|Drug|Sunitinib|
16113935|NCT02058875|Drug|Myfortic®|
16113936|NCT02058875|Drug|Neoral®|
16113937|NCT02058875|Drug|Cellcept®|
16113938|NCT02058875|Drug|Prednisone|
16113939|NCT02058849|Drug|Beetroot|10g Beetroot powder mixed with 4-8 oz.
16113940|NCT02058849|Other|Placebo|Placebo
16113941|NCT02058836|Drug|Botox Injection|One-time injection of 100 Units of Botox in 10 mL of saline. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.
16113942|NCT02058836|Procedure|Normal saline injection|One-time injection of 10 mL of 0.9% sodium chloride (normal saline) solution. The 10 mL injection will be distributed in 4 areas around the spermatic cord and testicle of the affected side with 2.5 mL being injected at each area.
16113943|NCT02058823|Drug|Placebo|The subjects receive 1 oral pill of placebo each morning during the second week of the two periods, so 14 pills in all.
16113944|NCT02058823|Drug|Placebo|The subjects receive 1 oral pill of placebo each morning during the second week of the two periods, so 14 pills in all.
16113945|NCT02058823|Drug|Valsartan|The subjects receive 1 oral pill of Valsartan each morning during the second week of the two periods, so 14 pills in all. 1 pill equal 40 mg.
16113946|NCT02058823|Drug|Amlodipine|The subjects receive 1 oral pill of Amlodipine each morning during the second week of the two periods, so 14 pills in all. 1 pill equal 6,944 mg of amlodipine besilate with 5 mg of amlodipine.
16113947|NCT02058810|Device|Nasal high flow|
16113948|NCT02058810|Device|Conventional nasal oxygen|
16113949|NCT02058797|Behavioral|Coherence Therapy|Manualized individual treatment (3 + 1 one-hour sessions)
16113950|NCT02058797|Behavioral|Cognitive Behavioral Therapy|Manualized individual treatment (3 + 1 one-hour sessions)
16113951|NCT02058784|Drug|pracinostat|
16113952|NCT02058758|Device|Magnetic Resonance Imaging|MRI scanning with novel acquisition, reconstruction, and/or analysis methods.
16113953|NCT02058745|Behavioral|CAU+ (Enhanced Care as Usual)|"CAU+ is defined as the care received from the care recipient's oncologist supplemented by unlimited access to three components of the study website: caregiver guides, links to web-based resources, and a basic friends and family page. These resources are routinely available on the Internet. We provide these as a one-stop shopping resource in order to standardize care as usual for caregivers. All caregivers will be sent personalized e-mails from the project director every week during the intervention period."
16113954|NCT02058745|Behavioral|Beating the Blues|"Beating the Blues is an established, self-directed, web-based cognitive behavioral therapy program for managing depressive symptoms. Caregivers are asked to complete 8 weekly sessions, each lasting approximately 50 minutes. Participants are also given simple homework after each lesson."
16113955|NCT02058745|Behavioral|SmartCare|SmartCare is a web-based, nurse guided intervention for caregivers based on the Representational Approach of symptom management. The RA builds on traditional cognitive-behavioral interventions by promoting in depth reflection of previous and current experiences, beliefs, and knowledge (referred to as representations) prior to providing new information or engaging in problem-solving.
16113956|NCT02058732|Other|MRI|Subjects will have an MRI that lasts approximately 60 minutes at the same time points as during the stem cell study schedule; once before the stem cell surgery, and again at 1, 6, 12, 18, 24, 36, and 48 months after receiving stem cells. This magnetic resonance imaging(MRI)scan will be of the cervical spine and brain.
16113957|NCT02058706|Drug|enzalutamide|Given PO
16113958|NCT02058706|Drug|bicalutamide|Given PO
16113959|NCT02058706|Procedure|orchiectomy|Undergo orchiectomy or receive LHRH analogue therapy
16113960|NCT02058706|Drug|leuprolide acetate|Undergo orchiectomy or receive LHRH analogue therapy
16113961|NCT02058706|Drug|goserelin acetate|Undergo orchiectomy or receive LHRH analogue therapy
16113962|NCT02058706|Other|laboratory biomarker analysis|Correlative studies
16113963|NCT02058693|Drug|mixed salts amphetamine|adjunctive to ADT
16113964|NCT02058680|Biological|PSA/IL-2/GM-CSF|"In Stage 1 (Phase 1A), patients receive intradermal injections of PSA/IL-2/GM-CSF vaccine at Weeks 1, 2, 3, 7, 11, and 15.
~In Stage 2 (Phase 1B), patients will receive the same course of vaccine (induction as in Phase 1A; this will be followed in eligible patients by maintenance vaccinations alternating between IL-2 alone at Weeks 23, 31, and 39) and complete vaccine (PSA/IL-2/GM-CSF) at Weeks 27, 35, and 43."
16113965|NCT02058667|Radiation|Paclitaxel+Initial Radiation+Boost|Paclitaxel twice weekly + Initial Fields Radiation + Boost Radiation (10Gy)
16113966|NCT02058654|Drug|Creatine|Creatine powder (5 g)
16113967|NCT02058654|Drug|Placebo|Bulking agent powder (5 g)
16113968|NCT02058641|Drug|Darapladib|EC tablet with a unit dose strength of 160 mg administered once daily orally for 11 days.
16113969|NCT02058628|Drug|Clindamycin + BPO|Gel containing 1.2% clindamycin and 3% BPO for once daily application
16113970|NCT02058628|Drug|Azelaic acid|Cream containing 20% azelaic acid for twice daily application
16113971|NCT02058615|Behavioral|Male Spouse Transition Toolkit|
16113972|NCT02058602|Other|Assessment of Idiopathic Pulmonary Fibrosis over a period of up to 6 months|Patients are receiving no treatment on this study and there is no investigational product involved.
16113973|NCT02058589|Biological|Herpes Zoster vaccine GSK1437173A|2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
16113974|NCT02058589|Drug|Placebo|2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
16113975|NCT02058576|Drug|Commercially available combination of dutasteride 0.5 mg and tamsulosin HCL 0.4 mg|Commercially available, orange and brown, hard shell capsule, administered orally as a single dose on Day 1 under fed condition.
16113976|NCT02058576|Drug|Second generation dutasteride 0.5 mg and tamsulosin HCL 0.4 mg combination capsule|Orange and brown, hard shell capsule, administered orally, as a single-dose on Day 1 under fed condition
16113977|NCT02058563|Biological|Priorix®|1 dose administered as a subcutaneous (SC) injection.
16113978|NCT02058563|Biological|Merck's M-M-R®II, Measles, Mumps, and Rubella Virus Vaccine|1 dose administered subcutaneously.
16113979|NCT02058550|Other|survey administration|Receive reminder email survey
16113980|NCT02058550|Other|computer-assisted intervention|Receive reminder email survey
16113981|NCT02058550|Behavioral|telephone-based intervention|Receive reminder phone call
16113982|NCT02058537|Drug|Bethanechol|Due to the fact that this study has only 1 arm and all study subjects will receive the study drug in the same manner and dose, there are no other details to cover.
16113983|NCT02058524|Biological|fecal microbiota transplantation|
16113984|NCT02058511|Drug|Anesthesia Premedication, Induction and Maintenance|"The enrolled patients receive standard of care general anesthesia for knee arthroscopy. No additional pharmacological interventions are performed in study participants.
~The administered drugs, as outlined in the arms section, are midazolam, fentanyl, propofol, and sevoflurane. Study patients receive analgesic drugs as needed in the recovery room if they experience pain."
16113985|NCT02058511|Procedure|Pupillometry after administration of anesthetic drugs|"All study patients receive the standard of anesthetic care. Every time a anesthetic drug has been administered, changes in pupillary oscillations will be recorded.
~Assessment of pupil size and movements by shining infrared light into the eye and measuring the reflection over a 20 s period
~The administered drugs are:
~Midazolam 1-2 mg iv, Fentanyl 1mcg/kg body weight, Propofol for anesthesia induction 2-2.5 mg/kg body weight, Sevoflurane as needed for maintenance of general anesthesia."
16113986|NCT02058498|Behavioral|Physical activity|Participants will be provided physical activity walking instructions and asked to record their daily activity on an activity log. Participants will be given the International Physical Activity Questionnaire and asked about their quality of life at baseline, at 6 weeks and at 4 months.
16113987|NCT02058485|Drug|Midazolam|Midazolam was calculated by actual body weight of patients that had been diluted with saline to 40 ml. It was administered 15 min before induction of anesthesia via intravenous infusion. at a dose of 0.025 mg.kg-1
16113988|NCT02058485|Drug|Dexmedetomidine|Dexmedetomidine was calculated by actual body weight of patients that had been diluted with saline to 40 ml. Dexmedetomidine was administered 15 min before induction of anesthesia via intravenous infusion. at a dose of 0.5 µg.kg-1
16113989|NCT02058472|Drug|G3041|
16113990|NCT02058472|Drug|SEVIKAR®|
16113991|NCT02058459|Device|Holaira™ Lung Denervation System with energy delivery|
16113992|NCT02058459|Device|Holaira™ Lung Denervation System without energy delivery|
16113993|NCT02058446|Drug|Amlodipine/Valsartan|Amlodipine/Valsartan: 5 mg/80 mg
16113994|NCT02058433|Other|dosage of paclitaxel|Based on pharmacokinetics. Observe the toxicity in an individual patient after a fixed Paclitaxel dose depending on BSA and then the dosage of Paclitaxel is adjusted depending on pharmacokinetics follow up to avoid excess toxicity in subsequent cycles.
16113995|NCT02058433|Other|dosage of paclitaxel|Based on body surface area. The dosage of Paclitaxel is based on the BSA of the patient. Paclitaxel/carboplatin up to 4 cycles or disease progression or intolerable toxicity.
16113996|NCT02058420|Drug|Low tocotrienols group|300 mg tocotrienols daily
16113997|NCT02058420|Drug|High tocotrienols group|600 mg tocotrienols daily
16113998|NCT02058407|Drug|GSK2793660 solution|Clear, colourless solution at a unit dose strength of 0.1 mg/mL, in a glass bottle
16113999|NCT02058407|Drug|GSK2793660 capsule|Size zero swedish orange capsule at a unit dose of 3 mg, 10 mg, 20 mg and 50 mg
16114000|NCT02058407|Drug|Placebo solution|Matching placebo to GSK2793660 solution
16114001|NCT02058407|Drug|Placebo capsule|Matching placebo to GSK2793660 capsule
16114002|NCT02058394|Procedure|Phacoemulsification|Subjects will be recruited serially from eligible candidates on the basis of presentation for cataract evaluation and subsequent cataract surgery with phacoemulsification.
16114003|NCT02058381|Drug|alpelisib (BYL719)|BYL 719 350 mg will be administered orally once daily on a continuous dosing schedule starting on day 1 (Group 1 only).
16114004|NCT02058381|Drug|buparlisib (BKM120)|BKM120 100 mg will be administered orally once daily on a continuous dosing schedule starting on day 1 (Group 2 only)
16114005|NCT02058368|Drug|Dutasteride 0.5mg capsules|Dutasteride 0.5mg capsules will be supplied as plain, oblong, opaque, dull yellow soft gelatin capsules.
16114006|NCT02058368|Drug|Dutasteride placebo capsules|Dutasteride placebo will be supplied as plain, oblong, opaque, dull yellow soft gelatin capsules.
16114007|NCT02058368|Drug|Tamsulosin 0.2mg tablets|Commercially available tamsulosin 0.2mg tablets will be supplied.
16114008|NCT02058368|Drug|Disintegrating placebo tamsulosin tablet|Disintegrating placebo tamsulosin tablet will be supplied for the run-in period.
16114009|NCT02058355|Behavioral|Consequences List Feedback|
16114010|NCT02058355|Behavioral|Personalized Normative Feedback|
16114011|NCT02058342|Behavioral|Active Play at Home|The Active Play at Home (APAH) curriculum includes age-appropriate goal-oriented physical activities that combine playground and video games using the Nintendo Wii™ with exercises targeting: muscular strength and endurance, aerobic endurance, flexibility, balance, agility, and motor coordination. APAH was designed for children ages 8-11 without disability and ages 8-15 years with PWS. The playground games and interactive console-based games are to be performed twice weekly each. The activity is progressed from 25 to 45 minutes of moderate to vigorous physical activity throughout the 24 weeks period. Parents and children are trained to use the curriculum hands-on at baseline.
16114012|NCT02058329|Other|Home Visit|A geriatric fellow will conduct a comprehensive in hospital post discharge assessment of hip fracture patients discharged to home in the intervention group.Follow up home visits will occur at 1,3 and 6 months post discharge.Any problems will be referred to the patient's primary care physician.
16114013|NCT02058316|Device|Lateral Flow Device Test|Testing of leftover BAL samples from clinical routine by the lateral flow device test
16114014|NCT02058303|Drug|Exparel Forearm block|20-30 mL Mepivacaine will be used for the supraclavicular block following the forearm block.
16114015|NCT02058303|Drug|Bupivacaine supraclavicular block|20-30mL 0.5% bupivacaine
16114016|NCT02058290|Drug|IV morphine sulfate or Sponsor-approved equivalent|Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to a floor if the stay in the PACU is less than one hour.
16114136|NCT02057367|Drug|Scalp block with 0.9% normal saline|Anterior scalp block will be done by using 0.9% normal saline 20 ml.
16114944|NCT02051322|Device|Aerobika Nebulizer|
16114017|NCT02058290|Drug|EXPAREL|"Patients will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 40 cc administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
~All patients will be offered rescue analgesia, as needed."
16114018|NCT02058277|Drug|bosutinib or bosutinib + aprepitant|Single dose of bosutinib (500 mg) or single dose of bosutinib (500 mg) and aprepitant (125 mg)
16114019|NCT02058264|Drug|BBI-4000|
16114020|NCT02058251|Drug|Oxytocin|One 40 IU dose of intranasal oxytocin will be self-administered (5 puffs in each nostril) by participants.
16114021|NCT02058251|Drug|Placebo|Each participant will self-administer a 40 IU dose of intranasal saline.
16114022|NCT02058212|Drug|ascorbate 1000mg, vitamin E 400, zinc and selenium|anti oxidant in the form of ascorbate 1000mg, vitamin E 400, zinc and selenium) are given to half patients only before IVF , plasma level of ROS are detected before and on day of oocyte retrieval then correlated to pregnancy outcome
16114023|NCT02058199|Drug|rivaroxaban|Single dose pharmacodynamic study
16114024|NCT02058186|Drug|oral vitamin D|
16114025|NCT02058186|Drug|Placebo|
16114026|NCT02058173|Drug|150 mg/daily chloroquine compare to placebo for 12 week|
16114027|NCT02058173|Drug|Chloroquine|
16114028|NCT02058173|Drug|placebo|
16114029|NCT02058160|Drug|Insulin glargine/lixisenatide (HOE901/AVE0010)|"Insulin glargine/lixisenatide FRC was self-administered by subcutaneous (SC) injection within 1 hour before breakfast using one of 2 SoloStar® pen-injectors: Pen A (ratio of 2 Units (U) of insulin glargine U 100:1 mcg of lixisenatide) or Pen B (ratio of 3 U of insulin glargine U 100:1 mcg of lixisenatide). After run-in, the FRC was initiated at a dose of either 20 U/10 mcg with Pen A or 30 U/10 mcg with Pen B, depending on participant's dose of Insulin glargine on the day prior to randomization.
~Dose was adjusted weekly to reach and maintain fasting self-monitored plasma glucose (SMPG) of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L). Pen A was used for administration of doses up to 40 U/20 mcg and Pen B for administration of doses from 30 U/10 mcg up to 60 U/20 mcg."
16114030|NCT02058160|Drug|Insulin glargine (HOE901)|"Insulin glargine was self-administered QD by SC injection at approximately the same time every day.
~After screening, eligible participants entered 6 week run-in phase during which they were switched (if necessary) to insulin glargine and dose was stabilized. The first dose after randomization was same as the one administered on the day prior to randomization and then dose was adjusted weekly to reach and maintain fasting SMPG of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L)."
16114031|NCT02058160|Drug|Metformin (Background Drug)|Pharmaceutical form: Tablet; Route of administration: Oral administration
16114032|NCT02058147|Drug|Insulin glargine/lixisenatide Fixed Ratio Combination|Insulin glargine/Lixisenatide FRC was self-administered by subcutaneous (SC) injection in the morning within one hour before breakfast using one of the 2 prefilled disposable SoloStar® pen-injectors: Pen A containing 100 U/mL insulin glargine (Lantus, 100 U/mL) and 50 mcg/mL lixisenatide in a ratio of 2 U:1 mcg, used for administration of doses from 10 U to 40 U (10 U/5mcg to 40 U/20mcg). Pen B containing 100 U/mL insulin glargine (Lantus, 100 U/mL) and 33 mcg/mL lixisenatide in a ratio of 3 U:1 mcg, used to administer doses from 41 U to 60 U (41 U/13 mcg to 60 U/20 mcg). The starting dose was 10 U/5 mcg. Dose was then adjusted individually to reach and maintain fasting self-monitored plasma glucose (SMPG) of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L) while avoiding hypoglycemia.
16114033|NCT02058147|Drug|Insulin glargine (HOE901)|Insulin glargine (100 U/mL) was self-administered by SC injection at approximately the same time every day. Dose was adjusted individually to reach and maintain fasting SMPG of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L) while avoiding hypoglycemia.
16114034|NCT02058147|Drug|Lixisenatide (AVE0010)|Lixisenatide was self-administered by SC injection within 0 to 60 minutes before breakfast or evening meal. If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 10 mcg.
16114035|NCT02058147|Drug|Metformin|Pharmaceutical form: Tablet; Route of administration: Oral administration.
16114036|NCT02058134|Device|cardioPAT cell saver|
16114037|NCT02058121|Behavioral|Acceptance and Commitment Therapy|ACT is provided in 12 weekly two hour long sessions in a group setting
16114038|NCT02058121|Behavioral|Treatment as usual|Treatment as usual contains different interventions available at the clinic, such as individual therapy, group therapy, or contact with a physician, dietician and/or physiotherapist.
16114039|NCT02058108|Drug|Telbivudine|Patients of any age and weight< 30kg: telbivudine oral solution (20 mg/mL): 20 mg/kg up to 600 mg q.d corresponding to weight (kg) x1mL, p.o. once daily Patients < 12 years old and weight≥ 30kg: telbivudine oral solution (20mg/mL), 600 mg/day corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: telbivudine film-coated tablet, 600 mg/day, corresponding to 1 tablet p.o. once daily
16114040|NCT02058108|Drug|Placebo|Patients of any age and weight < 30kg: placebo oral solution corresponding to weight (kg) x1mL, p.o. once daily Patients < 12 years old and weight ≥ 30kg: placebo oral solution corresponding to 30 mL p.o. once daily Patients ≥ 12 years old and weight ≥ 30kg: placebo tablet, corresponding to 1 tablet p.o. once daily
16114041|NCT02058095|Drug|Tadalafil|"Tadalafil 5 mg tablet. Daily. Tadalafil dose varies from 5 mg to 20 mg for 12 weeks. If blood pressure is >95 then subject dismissed from the Clinical Research Unit (CRU) on 2 (5 mg) tabs of tadalafil or placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tab of Tadalafil.
~At 2 weeks (± 5 days) if blood pressure is> 100 than add 1 (5 mg) tab of Tadalafil to make a total of 3 (5mg) tabs of Tadalafil.
~At 4 weeks(± 5 days) if blood pressure is > 100 add 1 (5 mg) tab to make a total of 4 (5 mg) tablets of Tadalafil."
16114042|NCT02058095|Drug|Placebo|"Placebo tablet. Daily. Placebo tablets made to match appearance of 5mg Tadalafil tablets. Placebo dose varies from 5 mg to 20 mg (1 to 4 tablets) for 12 weeks. If blood pressure is >95 then subject dismissed from CRU on 2 tabs of placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tablet of placebo.
~At 2 weeks (± 5 days) if blood pressure is> 100 than add 1 tab of placebo to make a total of 3 tablets of placebo.
~At 4 weeks(± 5 days) if blood pressure is > 100 add 1 (5 mg) tab to make a total of 4 tablets of placebo."
16114043|NCT02058082|Procedure|Intracytoplasmic sperm injection|
16114044|NCT02058069|Device|Robotic Arm Assisted Total Knee Arthroplasty|The total knee implant system used for this study was the Kinetis implant system (MAKO Surgical Corp.).
16114045|NCT02058056|Radiation|Irradiation: HA-PCI|25 Gy in 10 daily factions, five times a week
16114046|NCT02058030|Device|Insertion of ProSeal laryngeal mask airway|"The patient's head was placed on the 3 cm or 6 cm height of a pillow in supine and PLMA was inserted using a standard method in the sniffing position.
~The success rate at first and second attempt, insertion time, Seal pressure, hemodynamic variables, complications(blood staining on cuff, sore throat and hoarseness) were assessed"
16114047|NCT02058017|Drug|OPB-51602|
16114048|NCT02058004|Procedure|Cricoid pressure|Firm pressure on the cricoid cartilage with the goal of occluding the esophagus during endotracheal intubation.
16114049|NCT02057991|Other|educational intervention|Watch an educational video
16114050|NCT02057991|Procedure|CAM exercise therapy|Watch a mindfulness exercise video
16114051|NCT02057991|Other|caregiver-related intervention or procedure|Watch mindfulness exercise video and/or educational video
16114052|NCT02057991|Other|questionnaire administration|Ancillary studies
16114053|NCT02057991|Other|laboratory biomarker analysis|Correlative studies
16114054|NCT02057978|Procedure|EXCEL DES implatation|Implant DES for CAD cases
16114055|NCT02057978|Procedure|EXCEL-II DES implantation|Implant DES for CAD cases
16114056|NCT02057965|Drug|Mesenchymal Stromal Cells|Two doses of autologous bone marrow (BM) derived MSCs IV, 7 days apart, 6 and 7 weeks after transplantation. Doses of MSCs will be 1-2x10^6 million MSCs per/kg body weight
16114057|NCT02057952|Behavioral|Education and exercise|The active groups will meet twice a week for 75 minutes over six months. They will be followed for an addition six months to monitor maintenance.
16114058|NCT02057939|Drug|enzalutamide|160 mg orally once daily for six months
16114059|NCT02057939|Drug|Androgen Deprivation|Two injections each lasting three months, for a total of six months of androgen deprivation therapy. Doctor will help determine which androgen deprivation drug to use.
16114060|NCT02057939|Radiation|Radiation Therapy|Daily (Monday-Friday) for 6-8 weeks, final dose of approximately 66 Gy
16114061|NCT02057926|Drug|The effect of tetracycline in degradation and permeability of collagen membranes.|
16114062|NCT02057913|Drug|Vinflunine|All patients will receive on Day 1 of a 21 day cycle, vinflunine 320mg/m2 via intravenous infusion in either 100ml sodium chloride 0.9% or glucose 5% over 20 minutes; four cycles to be given in total prior to formal re-staging.
16114063|NCT02057900|Biological|Human embryonic stem cell-derived CD15+ Isl-1+ progenitors|Epicardial delivery of a fibrin patch embedding human embryonic stem cell-derived CD15+ Isl-1+ progenitors
16114064|NCT02057887|Drug|HM10660A|
16114065|NCT02057887|Drug|Pegasys|180 mcg Pegasys SC once weekly
16114066|NCT02057874|Device|3 Tesla Magnetic Resonance Imaging|3T MRI consists of a series of radiofrequency (RF) pulse sequences optimized for acquiring CEST-, MT-, DW-, and DCE-MRI data in one seamless imaging examination. For DCE, MR contrast agent will be intravenously administered.
16114067|NCT02057874|Drug|Magnevist® (Intravenous (IV) administration of MRI contrast agent)|For the acquisition of DCE-MR data, the FDA-approved contrast agent Magnevist® (gadopentetate dimeglumine, 0.1 mmol/kg) will be delivered intravenously by the MR technologist at a rate of 2 mL/sec (followed by a saline flush) via a power injector after the acquisition of a set of baseline dynamic scans. The entire sequence lasts approximately 8 minutes.
16114068|NCT02057848|Other|low amount of carbohydrates|different regimens of carbohydrate administration to prevent hypoglycaemia during a standardized bout of moderate physical activity in patients with type 1 diabetes
16114069|NCT02057848|Other|high amount of carbohydrates|different regimens of carbohydrate administration to prevent hypoglycaemia during a standardized bout of moderate physical activity in patients with type 1 diabetes
16114070|NCT02057848|Other|Rapid-acting carbohydrates|different regimens of carbohydrate administration to prevent hypoglycaemia during a standardized bout of moderate physical activity in patients with type 1 diabetes
16114071|NCT02057835|Drug|Placebo to BI 691751|Placebo to BI 691751
16114072|NCT02057835|Drug|BI 691751 high dose|BI 691751 high dose
16114073|NCT02057835|Drug|BI 691751 middle dose|BI 691751 middle dose
16114074|NCT02057835|Drug|Placebo to BI 691751|Placebo to BI 691751
16114075|NCT02057835|Drug|BI 691751 low dose 1|BI 691751 low dose 1
16114076|NCT02057835|Drug|Placebo to BI 691751|Placebo to BI 691751
16114077|NCT02057835|Drug|Placebo to BI 691751|Placebo to BI 691751
16114078|NCT02057835|Drug|BI 691751 low dose 2|BI 691751 low dose 2
16114079|NCT02057822|Procedure|Cytokins assay in tears|
16114080|NCT02057796|Device|Xpert MTB/RIF®, Determine TB LAM, Chest X-ray|"The following point-of-care TB tests will be systematically performed:
~Xpert MTB/RIF® on sputum (in all patients able to provide sputum; no sputum induction will be requested in others), Urine LAM (all patients). Depending on clinical presentation, Xpert MTB/RIF® will also be performed on any relevant extra-pulmonary specimen.
~TB treatment will depend on the result of the tests:
~Criteria met for confirmed or probable TB : TB treatment will be initiated immediately (Visit 1) followed by ART initiation 2 weeks later (Visit 2); No evidence of confirmed or probable TB: ART will be started immediately (Visit 1)."
16114081|NCT02057796|Drug|ART (Atripla, Truvada, Efavirenz, Combivir)|"ART (TDF-3TC/FTC or AZT-3TC + efavirenz) will be started immediately after randomization in patients not put on TB treatment, and 2 weeks after initiation of TB treatment in others.
~ART will be initiated 2 weeks after the onset of TB treatment (V2) for Arm 2"
16114082|NCT02057796|Drug|Rifampin, isoniazid, pyrazinamide, ethambutol|Arm 1: Only patients who meet standardized criteria for TB at inclusion or during follow-up will receive a standard TB treatment (2ERHZ/4RH); Arm 2: • All patients will start a 6-month standard TB treatment (2ERHZ/4RH) at randomization
16114083|NCT02057783|Other|Physical activity|Physical activity will carry out 3 times per week during 12 weeks for intervention arm
16114084|NCT02057770|Drug|busulfan|
16114085|NCT02057770|Drug|fludarabine phosphate|
16114086|NCT02057770|Radiation|total-body irradiation (TBI)|
16114087|NCT02057770|Procedure|Stem cell transplant|
16114088|NCT02057770|Drug|cyclophosphamide|
16114089|NCT02057770|Drug|tocilizumab|
16114090|NCT02057757|Drug|Nitazoxanide|"Participants 1 to 3 years old: 5 mL oral suspension (100 mg NTZ) every 12 hours for 5 days.
~Participants 4 to 11 years old: 10 mL oral suspension (200 mg NTZ) every 12 hours for 5 days.
~Participants 12 years and older: two 300-mg NTZ tablets orally twice daily for 5 days."
16114938|NCT02051335|Drug|Roflumilast placebo|Roflumilast placebo-matching tablets
16114091|NCT02057757|Drug|Placebo|"Participants 1 to 3 years old: 5 mL placebo oral suspension every 12 hours for 5 days.
~Participants 4 to 11 years old: 10 mL placebo oral suspension every 12 hours for 5 days.
~Participants 12 years and older: two placebo tablets orally twice daily for 5 days."
16114092|NCT02057731|Genetic|Glycogen Storage Disease markers|Blood and urine tests will be performed on all groups to measure markers of GSD. A saliva DNA test will be used to determine the specific mutation the carrier has or to ensure noncarrier status. A questionnaire will also be filled out.
16114093|NCT02057718|Drug|LUM001 (Maralixibat)|LUM001 also known as Maralixibat (MRX) oral dose up to twice a day (BID).
16114094|NCT02057692|Drug|LUM001|LUM001 administered orally
16114095|NCT02057692|Drug|Placebo|Placebo administered orally
16114096|NCT02057679|Drug|Amoxicillin clavulanic|3 g per day divided into 3 oral intakes of 1 g each (2 pill of Amoxicillin Clavulanic every 8 hrs). This treatment will begin on postoperative day 1 for 5 days.
16114097|NCT02057679|Drug|Placebo|1 pill of the same characteristics as Amoxicillin clavulanic every 8 hs. This will begin on postoperative day 1 for 5 days.
16114098|NCT02057666|Drug|Tasquinimod|A patient initially received a 0.25 mg/day dose which was then titrated through 0.5 mg/day (from Day 15) to a maximum of 1 mg/day (from Day 29). If tolerability issues arose at 0.5 or 1 mg/day, patients had their dose reduced to 0.25 or 0.5 mg/day, respectively.
16114099|NCT02057666|Drug|Placebo|Placebo capsules were identical to tasquinimod capsules in appearance and excipients but excluded the active compound (tasquinimod).
16114100|NCT02057640|Drug|Panobinostat|20mg, on day 1, 3, 5, 15, 17, 19, 28
16114101|NCT02057640|Drug|Dexamethasone|20mg, on day 1, 2, 8, 9, 15, 16, 28
16114102|NCT02057640|Drug|MLN9708|4mg on day 1, 8, 15, 28
16114103|NCT02057627|Behavioral|Perinatal Dyadic Psychotherapy|8-session mother-infant psychotherapy (Perinatal Dyadic Psychotherapy) delivered by nurse-interventionists in participant's homes over 3 months
16114104|NCT02057627|Behavioral|Placebo Comparator|Standard care plus depression monitoring by phone
16114105|NCT02057601|Drug|Levobupivacaine infiltration group|The patients in the intervention group will receive peri-surgical site infiltration before wound closure with a solution of levobupivacaine 0.5% 2mg/kg body weight with epinephrine made up to a volume of 1.5ml/kg with saline.
16114106|NCT02057588|Procedure|LV pacing site|Patient will be paced in VVI mode from Left ventricle specific position for a short period of time per position in order to cover spontaneous ventricular activity
16114107|NCT02057575|Drug|PG324 Ophthalmic Solution 0.01%|1 drop in the evening (PM), once daily (QD), both eyes (OU)
16114108|NCT02057575|Drug|PG324 Ophthalmic Solution 0.02%|1 drop in the evening (PM), once daily (QD), both eyes (OU)
16114109|NCT02057575|Drug|Netarsudil (AR-13324) Ophthalmic Solution 0.02%|1 drop in the evening (PM), once daily (QD), both eyes (OU)
16114110|NCT02057575|Drug|Latanoprost Ophthalmic Solution 0.005%|1 drop in the evening (PM), once daily (QD), both eyes (OU)
16114111|NCT02057549|Drug|Haloperidol|Intravenous dose of haloperidol 5 mg.
16114112|NCT02057549|Drug|Conventional Therapy|Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.
16114113|NCT02057536|Other|Arm A Directed exercise program|
16114114|NCT02057536|Other|Observation|
16114115|NCT02057523|Drug|Acthar|Those interested will be started on Acthar 80 units twice weekly for 6 months. Those with minor adverse effects such as weight gain, worsening hypertension, or glucose intolerance will have their doses reduced to 40 unit twice weekly. Those with major adverse effects such as allergy or infection will discontinue the medication. If the primary endpoint of 50% reduction in proteinuria or total proteinuria less than 150mg/day is not reached, therapy may be continued for a total of 12 months.
16114116|NCT02057484|Drug|Tacrolimus|oral
16114117|NCT02057471|Drug|Intravenous ferric carboxymaltose|1 gram intravenous ferric carboxymaltose (FERINJECT) will be administered to all patients within the study
16114118|NCT02057458|Drug|Sildenafil (Acute-1 hour)|Vascular function will be assessed 1 hour following oral ingestion of sildenafil (50 mg)
16114119|NCT02057458|Drug|Sildenafil (Subchronic-4 weeks)|Vascular function will be assessed 4 weeks following 20 mg three times per day (TID) of sildenafil for four weeks
16114120|NCT02057458|Drug|Placebo|Sugar pill designed to mimic the sildenafil treatment
16114121|NCT02057445|Drug|EBV CTL's|Eligible patients with a matched cell line will be infused with 3rd party CTLs and monitored for adverse events and response. Patients who show a response and tolerate the infusion well may receive up to 5 infusions total 4-6 weeks apart.
16114122|NCT02057445|Other|Peripheral Blood Donor|Donors who are EBV+ and meet the eligibility criteria will be consented to provide 60-120 ml peripheral blood once for future use for this and other clinical trials using 3rd party CTLs.
16114123|NCT02057432|Device|intra-operative MRI|Patients will undergo an MRI during surgery.
16114124|NCT02057406|Drug|2:1 EPA/DHA|400 Eicosapentaenoic acid/200 docosahexaenoic acid fish oil 2 grams
16114125|NCT02057406|Drug|High EPA|
16114126|NCT02057406|Other|Placebo|
16114127|NCT02057393|Drug|Indocyanine green|Subjects receive 0.9ml of ICG subcutaneously about the primary melanoma. The ICG has an infrared signal that is detected with the SPY Elite system (Lifecell). The ICG travels through the lymphatics to the sentinel node.
16114128|NCT02057393|Drug|Technetium99|Technetium99 is a standard, widely used radiopharmaceutical that is injected subcutaneoulsy about the primary melanoma site. Lymphoscintigraphy is performed to identify the draining nodal basin, and a gamma probe is used in the operating room to track the radioactive signal and find the sentinel node.
16114129|NCT02057393|Drug|Methylene blue|Subjects receive 0.5-2ml of methylene blue subcutaneously about the primary melanoma at the time of surgery. The sentinel node should turn blue, which is visible with the naked eye.
16114130|NCT02057380|Drug|linsitinib|oral
16114131|NCT02057380|Drug|erlotinib|oral
16114132|NCT02057380|Drug|paclitaxel|Intravenous (IV) infusion
16114133|NCT02057380|Drug|Bortezomib|Subcutaneous or IV
16114134|NCT02057380|Drug|Dexamethasone|IV, Oral
16114135|NCT02057367|Drug|Scalp block with 0.5% plain Marcaine|Anterior scalp block will be done by using 0.5% plain Marcaine 20 ml.
16114137|NCT02057354|Behavioral|Aerobic Exercise|The goal of the aerobic exercise training is to increase aerobic endurance. Walking on treadmill at moderate intensity with grade adjusted. Exercise tailored to individual ability level.
16114138|NCT02057354|Behavioral|Non-Aerobic Exercise|The goal of this training is to improve overall muscle strength, balance and flexibility. Participants will do strength, balance and stretching exercises. Exercises tailored to individual ability level.
16114139|NCT02057341|Drug|ARRY-371797, p38 inhibitor; oral|multiple dose, single schedule
16114140|NCT02057328|Drug|TELMISARTAN|Patients of the group of telmisartan will take 40 mg of telmisartan daily in the morning. At the end of the first month of treatment, patients classified in the normal BP range based on the results of ABPM will continue on the same medication scheme. Patients still classified in the stage I hypertensive range will receive 80 mg of telmisartan daily in the morning. At the end of the 6th month from the beginning of the study patients classified in the normal BP range will continue on the same medication scheme. For patients still classified in the stage I hypertensive range12,5 mg of hydrochlorothiazide will be added. The end of the 12-month period from the beginning of the study indicates the completion of the project.
16114141|NCT02057328|Drug|NEBIVOLOL|Patients will take 5 mg of nebivolol daily in the morning. At the end of the first month of treatment, patients classified in the normal BP range based on the results of ABPM will continue on the same medication scheme. Patients classified in the stage I hypertensive range the nebivolol group will receive 10 mg of nebivolol daily in the morning. At the end of the 6th month from the beginning of the study patients classified in the normal BP range based on the results of ABPM will continue on the same medication scheme. For patients classified in the stage I hypertensive range 12,5 mg of hydrochlorothiazide will be added. The end of the 12-month period from the beginning of the study indicates the completion of the project
16114142|NCT02057315|Drug|ELS-M11|One dose of 5% ELS-M11 over 3 bilateral applications.
16114143|NCT02057315|Drug|Placebo|One dose of matching placebo over 3 bilateral applications.
16114144|NCT02057302|Drug|Xuezhikang capsule|
16114145|NCT02057289|Drug|Micafungin|Micafungin (trade name Mycamine) is an echinocandin antifungal drug developed by Astellas Pharma. It inhibits the production of beta-1,3-glucan, an essential component of fungal cell walls. Micafungin is administered intravenously. It received final approval from the U.S. Food and Drug Administration on March 16, 2005, and gained approval in the European Union on April 25, 2008.
16114146|NCT02057276|Device|Repetitive Transcranial Magnetic Stimulation|We will use a specific rTMS paradigm called Continuous Theta Burst Stimulation (cTBS) for this study.
16114147|NCT02057276|Device|Sham Repetitive Transcranial Magnetic Stimulation|
16114148|NCT02057276|Other|Occupational Therapy|
16114149|NCT02057263|Drug|Alendronate|Participants will receive 4 doses of alendronate during the course of the study.
16114150|NCT02057263|Drug|Hepatitis B Vaccine|Participants will receive 3 Hepatitis B vaccinations, according to the schedule outlined by the CDC.
16114151|NCT02057263|Drug|Placebo|Participants will receive 4 doses of placebo during the course of the study.
16114152|NCT02057250|Drug|Sarilumab|Pharmaceutical form: Solution Route of administration: Subcutaneous
16114153|NCT02057250|Device|Auto-Injector Device (AID)|
16114154|NCT02057250|Device|Pre-filled Syringe (PFS)|
16114155|NCT02057250|Drug|Methotrexate|Dispensed according to local practice.
16114156|NCT02057250|Drug|Sulfasalazine|Dispensed according to local practice.
16114157|NCT02057250|Drug|Leflunomide|Dispensed according to local practice.
16114158|NCT02057250|Drug|Hydroxychloroquine|Dispensed according to local practice.
16114159|NCT02057237|Drug|Mitotane|Mitotane will be administered at a starting dose of 1.5 g/day and increased in case of good gastrointestinal tolerance every 3rd day by 0.5 g up to a maximal dose of 5.0 g and then adjusted according to blood concentrations monthly and tolerability, up to a maximum of 10g daily
16114160|NCT02057224|Procedure|Renal denervation using Medtronic Symplicity System (mono-electrode)|Secondary hypertension is excluded by an extensive preoperative clinical investigation and the renal artery anatomy is visualized by computer tomography (with contrast). By cannulating the femoral artery both renal arteries are treated by a radiofrequency-catheter, 4-6 ablations in each artery.
16114161|NCT02057211|Biological|autologous mesenchymal stem cell transplantation|
16114162|NCT02057211|Procedure|sham transplantation of mesenchymal stem cells|Placebo control for transplantation of mesenchymal stem cells
16114163|NCT02057198|Drug|Fidaxomicin|
16114164|NCT02057198|Drug|Metronidazole|
16114165|NCT02057198|Drug|Vancomycin|
16114166|NCT02057185|Behavioral|Study questionnaire|Questionnaire based on work situation of enrolled patients.
16114167|NCT02057185|Behavioral|SF-36 Questionnaire|Version 1.6
16114168|NCT02057172|Drug|HM11260C|HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue)
16114169|NCT02057172|Drug|liraglutide|Liraglutide is a GLP-1 agonist.
16114170|NCT02057172|Drug|Placebo|Placebo
16114171|NCT02057159|Biological|NeuroVax|TCR peptides in IFA
16114172|NCT02057159|Biological|IFA Placebo|IFA Placebo
16114173|NCT02057146|Procedure|Duodenoscopy, pancreatoscopy, cholangioscopy, confocal microscopy|The intervention consists of mother-baby endoscopy of the bile and/or pancreatic duct with visual inspection, confocal laser microscopy, collection of fluid for cytology, and eventually biopsy.
16114174|NCT02057133|Drug|LY2835219|Administered orally.
16114175|NCT02057133|Drug|Letrozole|Administered orally.
16114176|NCT02057133|Drug|Anastrozole|Administered orally.
16114177|NCT02057133|Drug|Tamoxifen|Administered orally.
16114178|NCT02057133|Drug|Exemestane|Administered orally.
16114179|NCT02057133|Drug|Everolimus|Administered orally.
16114180|NCT02057133|Drug|Trastuzumab|Administered IV infusion.
16114181|NCT02057133|Drug|LY3023414|Administered orally.
16114182|NCT02057133|Drug|Fulvestrant|Administered IM.
16114183|NCT02057133|Drug|Pertuzumab|Administered IV infusion.
16114184|NCT02057133|Drug|Loperamide|Administered orally.
16114185|NCT02057133|Drug|Endocrine therapy|Endocrine therapy administered orally.
16114283|NCT02056275|Other|Dietary Counseling|Dietary counseling provided at each study visit by study dietitian.
16114939|NCT02051335|Drug|Donepezil|Donepezil overencapsulated tablets
16114186|NCT02057120|Procedure|Kinesio Taping|Application of Kinesio (Kinesio Tex Gold ®) of black color. The tape will be applied from proximal to distal, leaving the anterosuperior iliac spine Bottom, passing over the Rectus Femoris and ending in the region of the anterior tibia tuberosity with a voltage of 25 %.
16114187|NCT02057120|Device|Kinesio Taping placebo|The volunteer who is allocated at random in the placebo group will receive an application of Kinesio transverse way the rectus femoris muscle, in order to verify a possible placebo effect of application of tape.
16114188|NCT02057107|Radiation|SBRT|8.8-10 Gy per fraction (total: 44-50 Gy)
16114189|NCT02057107|Drug|Cetuximab|"Day -7 (One week prior to commencement of stereotactic radiosurgery):
~Cetuximab, 400 mg/m2
~Days 0 and 8 (The 1st and 2nd week of radiosurgery):
~Cetuximab, 250 mg/m2 Cetuximab, 250 mg/m2 will be given weekly ( following radiosurgery)"
16114190|NCT02057107|Drug|Docetaxel|Days 0 and 8 (The 1st and 2nd week of radiosurgery) Docetaxel, 25 mg/m2 Docetaxel, 25 mg/m2 will be given weekly (following radiosurgery)
16114191|NCT02057094|Dietary Supplement|Protein, High-Protein, and Control|
16114192|NCT02057081|Behavioral|Multifamily Group for mTBI for Couples|MFG-mTBI-C uses a structured problem-solving and skills training approach to provide Veterans and partners with tools and information to improve coping and help couples reconnect through positive behavioral exchanges.
16114193|NCT02057081|Behavioral|Group Health Education (GHE)|GHE is a 14-session, highly structured educational intervention providing general information on health problems that are common among the general OEF/OIF cohort including sleep and sleep problems, physical activity and exercise, and alcohol and drug use, as well as guidelines for improving health behavior in these areas.
16114194|NCT02057068|Behavioral|SLEEP-E Dyads Intervention|Described in arm/group description
16114195|NCT02057055|Other|Soap 300000027003|
16114196|NCT02057055|Other|Soap 300000029240|
16114197|NCT02057042|Behavioral|Peer-assisted computerized CBT|Patients in the PS-cCBT intervention will receive usual depression care and will also receive: 1) access to Beating the Blues (BTB), an online cCBT program, 2) support of a peer specialists for 12 weeks, 3) a copy of the Depression Helpbook by Wayne Katon and colleagues
16114198|NCT02057042|Behavioral|Enhanced usual care|Patients randomized to EUC will receive the following enhancements: 1) patient education regarding the symptoms of depression and evidence-based depression treatments, 2) a copy of the Depression Helpbook by Wayne Katon and colleagues 3) information about how to access local VA mental health depression treatment resources (groups, individual psychotherapy, etc), and 4) bi-weekly study mailings with depression management tips.
16114199|NCT02057029|Behavioral|BCI Assay Results|The nature of the intervention is to utilize the BCI results in the decision making process for ER-positive breast cancer patients and their physicians.
16114200|NCT02057003|Drug|DAA against HCV|
16114201|NCT02056990|Other|Advice|
16114202|NCT02056977|Other|Titration|Individualized PEEP according to PEEP titration monitored by EIT
16114203|NCT02056977|Other|control|PEEP selected according to a PaO2/FIO2 table as in the routines of the institution
16114204|NCT02056951|Procedure|Multidisciplinary rehabilitation|"Multidisciplinary rehabilitation includes interventions from the physical and psychological dimensions:
~health education
~exercise therapy
~back school
~physical treatments
~psychological interventions in groups and individual counselling
~rehabilitation/social counselling."
16114205|NCT02056951|Procedure|Interprofessional rehabilitation|"Interprofessional rehabilitation includes also interventions from the physical and psychological dimensions:
~education about low back pain
~behavioural exercise therapy
~coping with pain
~relaxation
~work related informations"
16114206|NCT02056938|Drug|Anti-Thymocyte Globulins treatment|
16114207|NCT02056938|Drug|Basiliximab treatment|
16114208|NCT02056925|Other|Echocardiography|
16114209|NCT02056912|Genetic|Amplification by PCR and direct sequencing on the entire coding sequence and intron-exons boundaries of the candidate gene|
16114210|NCT02056912|Biological|Perform blood cells and fibroblasts biochemical and immuno-labeled investigations|Performed only in the two index patients enrolled in the sub-study
16114211|NCT02056899|Drug|Gabapentin|
16114212|NCT02056886|Procedure|SLN detection +/- complementary axillary lymphadenectomy|breast cancer surgery with SLN detection +/- complementary axillary lymphadenectomy Whatever the detection method used in the lab (Arm A: OSNA; Arm B: Pathological Examination; Arm C: Extemporaneous) to assess the positivity of sentinel lymph-node invasion, if negative result (no tumor invasion in the sentinel LN), a complementary lymph-node dissection is not mandatory if positive result (tumor invasion in the sentinel LN), a complementary lymph-node dissection is performed, either immediately (Arm A and C) or in a second surgical procedure (Arm B)
16114213|NCT02056873|Device|DBS System|"The DBS system includes an implantable neurostimulator, CM thalamic leads, and Electrocorticography (ECOG) strips.
~The DBS system will be set to provide continuous stimulation for the 6 months following surgery. Subjects will be seen monthly for evaluation as a part of normal clinical care for DBS. At 6 months, the investigators will determine whether or not the subject is a candidate for responsive brain stimulation (RBS). Qualifying subjects will have the option to have their settings changed in order to participate in the RBS stimulation intervention. Subjects who do not qualify or do not participate will continue to receive this intervention for the duration of the study. These subjects will been seen every 6 months for evaluation as part of normal clinical care for DBS."
16114214|NCT02056873|Device|DBS System (RBS Setting)|"The DBS system includes an implantable neurostimulator, CM thalamic leads, and Electrocorticography (ECOG) strips.
~Six months post-surgery, the DBS system will be set to provide responsive stimulation for the duration of the study. Subjects will be seen every 6 months for evaluation as a part of normal clinical care for DBS.
~Data gathered from the subject during the first 6 months will be used to determine if this intervention is applicable for each individual subject. Subjects who do not qualify will continue to receive the other study intervention."
16114215|NCT02056860|Procedure|Group 1 will receive 15 Hz|Group 1 (n=30), these subjects will receive 10 minutes of High Frequency Oscillation at 15 Hz at .75 cm on day 1. Then will have a 24 hour washout. On day 2 will receive 10 minutes of low Frequency Oscillation at 15 Hz at 1.25 cm.
16114216|NCT02056860|Procedure|Group 2 will receive 30 Hz|Group 2 (n=30), these subjects will receive 10 minutes of High Frequency Oscillation at 30 Hz at .75 cm on day 1. Then will have a 24 hour washout. On day 2 will receive 10 minutes of low Frequency Oscillation at 30 Hz 1.25 cm.
16114367|NCT02055742|Device|illumigene CT and NG assays, illumipro-10|
16114217|NCT02056860|Procedure|Group 3 will receive 60 Hz|Group 3 (n=30), these subjects will receive 10 minutes of High Frequency Oscillation at 60 Hz .75 cm on day 1. Then will have a 24 hour washout. On day 2 will receive 10 minutes of low Frequency Oscillation at 60 Hz at 1.25 cm.
16114218|NCT02056860|Procedure|Group 4 will receive 100 Hz|Group 4 (n=30), these subjects will receive 10 minutes of High Frequency Oscillation at 100 Hz at .75 cm on day 1. Then will have a 24 hour washout. On day 2 will receive 10 minutes of low Frequency Oscillation at 100 Hz at 1.25 cm.
16114219|NCT02056860|Procedure|Phase II Optimal Frequency|Participants in Phase II will undergo 10 minutes of HFO at the optimal frequency as determined during Phase I.
16114220|NCT02056847|Drug|Pitavastatin calcium 4mg|taking once a day
16114221|NCT02056847|Drug|Pitavastatin calcium 2mg|Taking once a day
16114222|NCT02056834|Device|chronOS Inject|chronOS Inject is used as bone void filler in internal fixation of proximal tibial fractures
16114223|NCT02056808|Drug|SMT C1100|Comparison of safety and pharmacokinetic of different dosages of drug
16114224|NCT02056795|Device|Asia-Med Special No 16 (0.30x30mm) needles|Subjects will do balance assessment in lab. In treatment room, practitioner will clean insertion area with alcohol swab, allow adequate time to dry, and insert 2 Asia-Med Special No 16 (0.30x30mm) needles: one at proximal insertion of fibularis longus anterior to fibular neck, in proximity to common fibular nerve (GB-34); one over sinus tarsi and lateral ligaments of ankle mortise (GB-40). Needles will be inserted approximately 1-2cm, connected for 10 min at 2Hz to electrical stimulation (ITO ES-130, 500 ohm test load, 1 to 500Hz). Needles will disposed of in sharps container. Area will be wiped with long handled cotton swab, pressure will be applied for 2 seconds. Subjects will be asked to slowly get up from table and return to lab for second balance assessment.
16114225|NCT02056795|Device|Streitberger placebo needles (Asia-Med, 0.03 x 30 mm)|As with experimental group, controls will do balance assessment pre- and post-intervention. Streitberger placebo needles (Asia-Med, 0.03 x 30 mm), blunted with a telescoping mechanism, will be used. Subjects will feel slight prick, and shaft will telescope into handle, creating illusion of skin penetration. Needles will be held in place by plastic ring covered by a bandage. They are validated for blinding. They will be placed over non-traditional acupuncture points on medial aspect of leg, in direct opposition to treatment group needles. Needle placement is not intended to produce therapeutic outcome. The needles will be connected to a wire, which will be turned on for 10 minutes but no stimulation will be felt.
16114226|NCT02056782|Drug|PGX-ODSH-2013-AML-1|"Eligible patients will receive idarubicin at 12 mg/m2 days 1-3 of induction plus a seven-day continuous infusion of cytarabine at 100 mg/m2/day days 1-7 of induction. For consolidation, patients younger than 60 will receive cytarabine at 3 grams/m2 over 3 hours every 12 hours days 1, 3, and 5 of the cycle. Patients over 60 will come off study following induction.
~In induction, ODSH will be administered as a 4 mg/kg bolus 30 minutes after the first idarubicin dose followed immediately by a continuous intravenous ODSH infusion of 0.25 mg/kg/hour for 24 hours daily for seven consecutive days (days 1-7) for a total of 168 hours of continuous ODSH infusion.
~In consolidation, ODSH will be administered as a 4 mg/kg bolus 30 minutes after completion of the first 3-hour infusion of cytarabine, followed immediately by a continuous ODSH intravenous infusion of 0.25 mg/kg/hour for 24 hours daily for five consecutive days (days 1-5) for a total of 120 hours of continuous ODSH infusion."
16114227|NCT02056769|Radiation|CT Perfusion|Quantitative CT Perfusion imaging
16114228|NCT02056756|Drug|Carfilzomib|
16114229|NCT02056743|Drug|CYP cocktail|Each group administered CYP cocktail (Caffeine 200mg + Losartan 50mg + Omeprazole 20mg + Dextromethorphan 30mg + Midazolam 7.5mg) under fasting conditions.
16114230|NCT02056743|Drug|Fexofenadine 30mg|Each group administered Fexofenadine 30mg under fasting conditions.
16114231|NCT02056743|Dietary Supplement|Red ginseng|During 4~17th days, end of the period 1, the group of red ginseng administered red ginseng extract.
16114232|NCT02056743|Dietary Supplement|Fermented-red ginseng|During 4~17th days, end of the period 1, the group of fermented-red ginseng administered fermented-red ginseng extract.
16114233|NCT02056730|Drug|calcium sensing receptor agonist|For the Regpara those taking 25 mg per day to get the default dose and the dose is adjusted according to the levels of calcium and parathyroid hormone. By adjusting the dose of 25 mg every 3 weeks for a period of 12 weeks, the drug is between 25-75 mg dose, with a maximum dose of not more than 100 mg per day (weeks 3, 6, 9).
16114234|NCT02056717|Drug|Dexamethasone|Administration of dexamethasone 10 mg IV 1 h before UAE
16114235|NCT02056717|Drug|Normal saline|Administration of normal saline 2 mL IV 1 h before UAE
16114236|NCT02056704|Device|Angiography with IVUS|The use of IVUS to evaluate dialysis access failure.
16114237|NCT02056691|Procedure|Exercise programme|The exercise regime consists of 10 sessions of exercise against a constant load, each lasting 60 seconds, separated by 60 seconds of recovery eliciting 90% maximal heart rate. The 6 sessions are held over a 2 week period.
16114238|NCT02056691|Procedure|Muscle biopsy|muscle biopsy under local anaesthetic taken from the thigh, again for analysis and storage 3 times: before, during and after the exercise programme
16114239|NCT02056678|Drug|acetaminophen, IV preparation|
16114240|NCT02056665|Drug|MINOCYCLINE|Pill Minocycline 50 mg capsule
16114241|NCT02056665|Drug|PLACEBO (for Minocycline)|Pill manufactured to mimic Minocycline 50 mg capsule
16114242|NCT02056652|Device|Bioteque cup pessary|
16114243|NCT02056639|Device|Bioteque cup pessary|
16114244|NCT02056626|Drug|carvedilol|
16114245|NCT02056600|Drug|gemigliptin and metformin HCl extended release|Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg, for 1 day
16114246|NCT02056600|Drug|gemigliptin/metformin HCl sustained release|Administration of combination of gemigliptin 50mg/metformin HCl sustained release 1000mg, for 1day.
16114247|NCT02056587|Drug|Everolimus|All patients with metastatic renal cell carcinoma progressing on prior treatment with bevacizumab ± interferon enrolled into this study will receive everolimus in the dose of 10 mg daily until the disease progression or unacceptable toxicity.
16114248|NCT02056574|Drug|NA-1|
16114249|NCT02056574|Drug|Placebo|
16114250|NCT02056535|Behavioral|Brief Motivational Intervention|A short discussion is held with patients identifying pros and cons of their drinking, readiness for change is assessed, and a brief prescription drawn for behavior change signed by the patient.
16114549|NCT02054364|Behavioral|FBT and CRT|
16114550|NCT02054364|Behavioral|FBT and art therapy|
16114251|NCT02056496|Dietary Supplement|Pomegranate extract|Crossover study: The group will consume the pomegranate extract with low punicalagin:EA ratio (PE-1). After 2 weeks of washout, the same group will also consume the other extract with high punicalagin: EA ratio (PE-2).
16114252|NCT02056496|Dietary Supplement|Pomegranate extract|Crossover study: The group will consume the pomegranate extract with high punicalagin:EA ratio (PE-2) after 2 weeks of washout. The same group will also consume the other extract with low punicalagin: EA ratio (PE-1).
16114253|NCT02056483|Other|Screening-based nurse navigation|Screening-based nurse navigation for breast cancer rehabilitation
16114254|NCT02056470|Device|Freedom Total Knee|The Freedom Total Knee System is being implanted in subjects suitable for a total knee replacement
16114255|NCT02056470|Device|Total Knee Replacement|total Knee replacement implant
16114256|NCT02056470|Device|Freedom Total Knee System|Total Knee replacement implant
16114257|NCT02056457|Behavioral|Responsible Fatherhood or Healthy Marriage Program|RF grantees funded by the most recent re-authorization of the program must offer services in each of three categories: (1) healthy marriage; (2) responsible parenting; and (3) economic stability. HM grantees must provide one or more of eight allowable activities, which include marriage and relationship skills programs, mentoring, divorce reduction programs, and education in high schools on the value of marriage, relationships skills, and budgeting.
16114258|NCT02056457|Behavioral|Other services in the community|RF grantees funded by the most recent re-authorization of the program must offer services in each of three categories: (1) healthy marriage; (2) responsible parenting; and (3) economic stability. HM grantees must provide one or more of eight allowable activities, which include marriage and relationship skills programs, mentoring, divorce reduction programs, and education in high schools on the value of marriage, relationships skills, and budgeting.
16114259|NCT02056444|Drug|Tranexamic Acid|
16114260|NCT02056431|Behavioral|IVR Intervention Group|Participants will receive 3 interactive voice response (IVR) calls (2nd, 4th, and 6th month post-treatment start date) to collect information on medication use, side effects, rating of side effects, and pain symptoms to be fed back to their physicians.
16114261|NCT02056418|Dietary Supplement|enteral nutrition|enteral nutrition only (Nutrison Fibre, 20-30kcal/kg/day)
16114262|NCT02056418|Drug|corticosteroid|corticosteroid(equal dose to prednisone 0.75mg/kg/day,4 weeks)
16114263|NCT02056405|Drug|Mosapride|15 mg per day divided into 3 oral intakes of 5 mg each (1 pill of Mosapride every 8 hs with 30 ml tap water). This treatment will begin on postoperative day 1 until discharge from Hospital or unacceptable toxicity develops.
16114264|NCT02056405|Drug|Placebo|1 pill of the same characteristics as Mosapride every 8 hs with 30 ml tap water. This will begin on postoperative day 1 until discharge from Hospital or unacceptable toxicity develops.
16114265|NCT02056392|Drug|Selumetinib|Volunteers will receive 75 mg selumetinib oral dose (Treatment A)
16114266|NCT02056392|Drug|Moxifloxacin|Volunteers will receive 400 mg Moxifloxacin oral dose (Treatment B)
16114267|NCT02056392|Drug|selumetinib placebo|Volunteers will receive selumetinib placebo oral dose (Treatment C)
16114268|NCT02056379|Drug|Budesonide|The subjects will receive a 5 ml normal saline inhalation right after extubation and will be re-evaluated in 5 to 10 minutes. The ones who develop upper airway obstruction and stridor with a Downes-Raphaelly score of 2 or higher will receive 0.5 ml/kg of inhaled epinephrine 1:1000 diluted to a final volume of 5 ml with a maximum dose of 2.5 ml in children up to 4 years and 5 ml in children with 5 years and above, as recommended by the American Academy of Pediatrics. The subjects who do not show an improvement after the epinephrine treatment will then be randomized to receive 2 mg of inhaled budesonide and 3 ml of IV normal saline. If there is an improvement the following maintenance therapy will be instituted for 48 hs and the subjects will receive 2 mg of budesonide q12hs and 3 ml of IV NS q6hs.
16114269|NCT02056379|Drug|Dexamethasone|The subjects will receive a 5 ml normal saline inhalation right after extubation and will be re-evaluated in 5 to 10 minutes. The ones who develop upper airway obstruction and stridor with a Downes-Raphaelly score of 2 or higher will receive 0.5 ml/kg of inhaled epinephrine 1:1000 diluted to a final volume of 5 ml with a maximum dose of 2.5 ml in children up to 4 years and 5 ml in children with 5 years and above, as recommended by the American Academy of Pediatrics. The subjects who do not show an improvement after the epinephrine treatment will then be randomized to receive 8 ml of inhaled normal saline and 0.6 mg/kg of IV dexamethasone. The dexamethasone group will receive 8 ml of inhaled NS q12hs and 0.15 mg/kg/dose of dexamethasone q6hs.
16114270|NCT02056366|Drug|α-lipoic acid|α-lipoic acid 600mg PO medication,Per day, For 6weeks α-lipoic acid 1200mg PO medication,Per day, For 6weeks
16114271|NCT02056353|Device|LOGIC-Insulin algorithm|
16114272|NCT02056353|Device|Paper protocol|
16114273|NCT02056340|Drug|Atorvastatin|
16114274|NCT02056340|Drug|Placebo|
16114275|NCT02056327|Device|A novel monitoring suite of sensors will be inserted into the standard oral device.|
16114276|NCT02056314|Other|electronic tutorial|The electronic tutorial will provide information to the participants about the nature of gambling, and how to protect themselves against the risks of problem gambling including information on coping skills, and myths associated with gambling.
16114277|NCT02056314|Other|brochure|The brochure is the current means of informing people about the risks of problem gambling. It includes information about problem gambling and help resources.
16114278|NCT02056301|Drug|Hydromorphone|In keeping with standard practice at the TCH, the position of the thoracic epidural catheter tip will be confirmed by real time fluoroscopy and a single injection of 1 ml of omnipaque 180 mg/mL contrast. In keeping with current practice, a bolus of 0.2% ropivacaine 0.3 ml per kg (maximum dose 20 ml) will be administered in the epidural space to the patients in the TEA group at least 10 minutes prior to surgical incision.
16114279|NCT02056301|Drug|Morphine|This device runs a basal infusion of pain medicine (morphine) intravenously with additional allowable patient controlled doses every 10 minutes
16114280|NCT02056288|Drug|Fentanyl|Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction.
16114281|NCT02056288|Drug|Ropivacaine|Patients randomized to the systemic analgesia group will receive 1mcg/kg of fentanyl IV after induction. Patients randomized to the supraclavicular block group will receive an ultrasound guided nerve block with 0.2 ml/kg ropivacaine 0.5% (maximum 10 ml).
16114282|NCT02056275|Other|Nutrition supplement + dietary counseling|Nutritionally balanced nutritional supplement providing 1.0 kcal/ml.
16114284|NCT02056262|Other|Dental cavity evaluation|The dental cavities present will be evaluated using the ICDAS (International Caries Detection and Assessment System).
16114285|NCT02056262|Biological|Saliva sampling|A saliva sample will be harvested.
16114286|NCT02056262|Biological|Plaque sampling|Plaque samples from a healthy tooth and a tooth with a cavity will be harvested.
16114287|NCT02056249|Other|Norepinephrine Transporter (NET) ligand|Norepinephrine Transporter (NET) ligand for iv administration during Positron Emission Tomography scan to measure changes in brain NET concentration based on insulin levels.
16114288|NCT02056236|Drug|Anti-epileptic drugs|"Recommendations for the treatment of status epilepticus are based on recent international guidelines for treatment of overt status epilepticus.
~The objective of treatment with AED is to suppress all epileptiform activity. There is no clear proof that induction of a burst-suppression pattern is of additional value and induction of burst suppression is therefore not obligate. If the electroencephalographic status epilepticus returns after tapering sedative treatment at 24 hours, the procedure will be repeated. If the status returns after 2 x 24 hours, it will be considered refractory.
~Decisions regarding limitation or withdrawal of treatment will be done in accordance with the Dutch guideline postanoxic coma. Reasons for withdrawal of treatment will be documented."
16114289|NCT02056236|Other|No anti-epileptic drugs|"The non-intervention group will be treated conform standard guidelines of treatment of comatose patients after cardiac arrest, but without anti-epileptic drugs or EEG based deep sedation. Treatment to suppress clinical myoclonia or seizures with low dose propofol is left to the discretion of the treating physician.
~Decisions regarding limitation or withdrawal of treatment will be done in accordance with the Dutch guideline postanoxic coma. Reasons for withdrawal of treatment will be documented."
16114290|NCT02056223|Drug|Intravenous paracetamol|15 mg/Kg every 6 hours for three days
16114291|NCT02056223|Drug|Intravenous ibuprofen|10 -5-5 mg/Kg once a day for three days
16114292|NCT02056210|Drug|Mozobil|Subcutaneous injection of 0.24 mg/kg Mozobil once at 8:30am
16114293|NCT02056197|Other|Placebo|Shortwave
16114294|NCT02056197|Other|Stable surface exercises|Stable surface exercises
16114295|NCT02056197|Other|Unstable surface exercises|
16114296|NCT02056184|Drug|Adalimumab|
16114297|NCT02056171|Drug|quetiapine|Patients who are diagnosed with delirium and assigned to the intervention arm will receive quetiapine.
16114298|NCT02056171|Other|Placebo|Patients who are diagnosed with delirium and assigned to the placebo arm will receive placebo.
16114299|NCT02056145|Procedure|LFCNB|LFCNB - Normal Saline solution 10 cc
16114300|NCT02056145|Procedure|FNB|FNB - Normal saline solution 10 cc
16114301|NCT02056145|Procedure|LFCNB|LFCNB - Chirocaine 0.25%, 20 cc
16114302|NCT02056145|Procedure|FNB|FNB - Chirocaine 0.25%, 20 cc
16114303|NCT02056132|Other|Exhaled Breath Condensate|Lab results of Exhaled Breath Condensate
16114304|NCT02056119|Device|Vibrating Mesh Nebulizer Arm|"Physician order received for subject, randomization to vibrating mesh nebulizer occurred.
~Aeroneb® Solo (Aerogen, Galway, Ireland) vibrating mesh nebulizer to be placed before the heater on the dry side of the heater water chamber on the inspiratory ventilator circuit.
~Aerosol treatment delivered per physician order.
~Mesh nebulizer to be replaced every 30 days per hospital protocol. a. Prior to every nebulizer change or every 3 days, study staff to be notified in order to obtain cultures."
16114305|NCT02056119|Device|Jet Nebulizer Arm|"Physician order received for subject, randomization to jet nebulizer occurred.
~Jet nebulizer, Misty Max 10™ (Carefusion, CA), placed into spring loaded t-piece between the humidifier and the ventilator (approximately 15 cm from the gas outlet).
~Aerosol treatment delivered per physician order at flow rates of 8-10 L/min.
~Jet nebulizer to be replaced every 3 days per hospital protocol. a. Prior to every nebulizer change or every 3 days, study staff to be notified in order to obtain cultures."
16114306|NCT02056106|Drug|antidepressant therapy|
16114307|NCT02056093|Device|PSV mode|Application of PSV in all patients
16114308|NCT02056093|Device|PAV mode|Application of PAV mode in all patients
16114309|NCT02056093|Device|NAVA|
16114310|NCT02056067|Behavioral|Exercise|The exercise intervention group will receive social, behavioral support and research staff contact time to encourage them to increase their activity level to include twice weekly strength-training sessions and 150 min of walking/week (e.g., three 50-min walking sessions or five 30-min walking sessions) over 12 months.
16114311|NCT02056067|Behavioral|Attention Control (Health Education)|The Attention Control Group will be provided written information that emphasizes the importance of a healthy lifestyle. Participants will be encouraged to follow the NCI and ACS physical activity guidelines. This procedure was followed in our exercise trials, with no increase in physical activity levels observed at follow-up among women in the usual care group. Attention Control participants will also receive frequent contacts throughout the 12 month intervention. Each month, women randomized to attention control will be contacted by phone to discuss a health education topic of interest
16114312|NCT02056054|Other|Pediatric transplant subject with d-AIH|30 ml of blood will be collected during periods of disease quiescence and activity in recipients with d-AIH who are enrolled. The exact number of blood draws will depend on the patient's pattern of disease activity. No more than one blood draw will take place during an 8-week period. The maximum amount of blood draws over the 2 year study period will be 8.
16114313|NCT02056054|Other|Pediatric transplant subject with acute rejection|Recipients with acute rejection will have blood drawn at time of diagnosis before treatment for rejection is instituted.
16114314|NCT02056054|Other|Pediatric transplant subject with chronic rejection|Recipients with chronic rejection will have blood drawn either at diagnosis before treatment is instituted or for those with ongoing chronic rejection at the time of enrollment.
16114315|NCT02056054|Other|Adult non-transplant patients with auto-immune hepatitis|"75 ml of blood will be collected during periods of disease quiescence and activity in non transplanted subjects with AIH who are enrolled. Research blood draws will be drawn along with clinical blood draws.
~The exact number of blood draws for each subject will depend on his or her pattern of disease activity. No more than one blood draw will take place during an 8-week period. The maximum amount of blood draws over the 2 year study period will be 8.
~Liver tissue (2 mm) will be obtained at the time a clinically indicated liver biopsy is performed.
~In the event that any enrolled subject undergoes liver transplantation, a portion of the explanted liver will be obtained and stored in special media."
16114991|NCT02050906|Procedure|quality-of-life assessment|Ancillary studies
16114316|NCT02056054|Other|Adult non-transplant subjects with chronic hepatitis C virus|"For enrolled patients with chronic hepatitis C, 75 ml of blood will be collected before the start of treatment. This will be a onetime blood draw prior to treatment. Liver tissue (2 mm) will be obtained at the time a clinically indicated liver biopsy is performed.
~In the event that any enrolled patient undergoes liver transplantation, a portion of the explanted liver will be obtained and stored in special media."
16114317|NCT02056054|Other|Pediatric control subjects|2 tablespoons of blood (30 ml) will be collected at each blood draw over a 2-year period. . The maximum amount of blood draws will be 3 however there will be no more than 1 blood draw within an 8-week period.
16114318|NCT02056054|Other|Adult transplanted subjects with de novo autoimmune hepatitis|75 ml of blood will be collected during periods of disease quiescence and activity in recipients with d-AIH who are enrolled. The exact number of blood draws for each subject will depend on his or her pattern of disease activity. However, no more than one blood draw will take place during an 8-week period. The maximum amount of blood draws over the 2-year study period will be 8.
16114319|NCT02056041|Procedure|Hepatectomy|
16114320|NCT02056028|Procedure|Hepatic resection|
16114321|NCT02056015|Drug|[68Ga]MLN6907|IV Administration of [68Ga]MLN6907 on Day 1
16114322|NCT02056002|Other|Usual Care|- Standard CPAP educational training
16114323|NCT02056002|Other|Peer-Buddy System|"Two 30-minute in person sessions with Peer Buddy
~Standard CPAP educational training
~Eight phone conversations with Peer Buddy over 3 months
~Subsequent 3 months use of phone system to contact Peer Buddy as needed
~One Month Visit:
~- Home visit to collect CPAP information
~Three Month Visit:
~Questionnaires
~Psycho Motor Vigilance Test (PVT) Video Game
~Collect CPAP information
~Measure weight
~Measure blood pressure
~Six Month Visit:
~Questionnaires
~PVT (Video game)
~Collect CPAP information
~Measure Weight
~Measure Blood Pressure
~Evaluate the program and Peer Buddy"
16114324|NCT02056002|Other|Usual Care|- Educational Brochures
16114325|NCT02056002|Other|Usual Care|- Educational DVD videos mailed to participant
16114326|NCT02055989|Radiation|Dose-escalated radiotherapy level 1|
16114327|NCT02055989|Radiation|Sequential dose-escalated radiotherapy level 2|
16114328|NCT02055976|Drug|Bococizumab (PF-04950615;RN316)|Atorvastatin plus PF-04950615 50 mg subcutaneous administration at every two weeks (Q14D SC) for 16 week
16114329|NCT02055976|Drug|Bococizumab (PF-04950615;RN316)|Atorvastatin plus PF-04950615 100 mg Q14D SC for 16 week
16114330|NCT02055976|Drug|Bococizumab (PF-04950615;RN316)|Atorvastatin plus PF-04950615 150 mg Q14D SC for 16 week
16114331|NCT02055976|Drug|Placebo|Atorvastatin plus PF-04950615 Placebo Q14D SC for 16 week
16114332|NCT02055976|Drug|Ezetimibe|Atorvastatin plus Ezetimibe 10 mg oral administration once daily for 16 week (open)
16114333|NCT02055976|Drug|Bococizumab (PF-04950615;RN316)|50 mg Q14D SC for 16 week
16114334|NCT02055976|Drug|Bococizumab (PF-04950615;RN316)|100 mg Q14D SC for 16 week
16114335|NCT02055976|Drug|Bococizumab (PF-04950615;RN316)|150 mg Q14D SC for 16 week
16114336|NCT02055976|Drug|Placebo|Placebo Q14D SC for 16 week
16114337|NCT02055963|Drug|Minocycline|100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery) and continuing for 3 weeks postsurgery.
16114338|NCT02055963|Drug|Placebo|Placebo 100 mg given orally every 12 hours on Day -2, (i.e., 2 days prior to surgery) and continuing for 3 weeks postsurgery.
16114339|NCT02055963|Behavioral|Questionnaires|Questionnaire completion 2 days before surgery, on day of surgery, 1 and 3 days after surgery, then twice a week until follow up visit on day 21.
16114340|NCT02055950|Procedure|Storage of kidney in refrigerated solution|
16114341|NCT02055950|Procedure|Kidney perfused by pulsatile machine|
16114342|NCT02055937|Procedure|immediate implant breast reconstruction|Eligible patients will undergo radical mastectomy with axillary lymph nodes sampling followed by immediate and single-stage breast reconstruction using the acellular dermal matrix Strattice™
16114343|NCT02055924|Drug|Ibrutinib and immunochemotherapies|Combination of immunochemotherapies (R-DHAP or R-DHAOx) and ibrutinib
16114344|NCT02055911|Drug|Ranibizumab|monthly ranibizumab (0,5 mg injected intravitreally in a standard fashion) until maximum visual acuity (VA) is achieved and remains stable for three consecutive months (for a minimum of 3 initial injections).
16114345|NCT02055898|Drug|Sodium Oxybate|
16114346|NCT02055898|Other|placebo (fresh potable water)|
16114347|NCT02055872|Drug|Intravenous albumin|
16114348|NCT02055872|Drug|Normal saline|
16114349|NCT02055859|Radiation|Radiosurgery|
16114350|NCT02055846|Procedure|Realisation of blood sample, urinary sample and tumor biopsy|
16114351|NCT02055833|Dietary Supplement|Intensive nutritional counseling|Intensive nutritional counseling: nutritional counseling + oral nutritional supplements
16114352|NCT02055833|Other|Nutritional counseling|Nutritional counseling
16114353|NCT02055820|Drug|Venetoclax|Venetoclax 200 to 800 milligrams (mg) tablets will be administered orally once daily (QD) on Days 4-10 of Cycle 1 and Days 1-10 of Cycles 2-8 during Phase I and MTD will be administered according to the same schedule during Phase II.
16114354|NCT02055820|Drug|Cyclophosphamide|Cyclophosphamide 750 milligrams per square meter (mg/m^2) administered intravenously (IV) on Day 1 of each 21-day cycle up to Cycle 6.
16114355|NCT02055820|Drug|Obinutuzumab|Obinutuzumab will be administered by IV infusion as an absolute dose of 1000 mg on Days 1, 8, 15 of Cycle 1 and Day 1 of Cycles 2-8 (cycle length = 21 days).
16114356|NCT02055820|Drug|Rituximab|Rituximab 375 mg/m^2 dose will be administered IV on Day 1 of every 21-day cycle.
16114357|NCT02055820|Drug|Doxorubicin|Doxorubicin 50 mg/m^2 administered IV on Day 1 of each 21-day cycle up to Cycle 6.
16114358|NCT02055820|Drug|Vincristine|Vincristine 1.4 mg/m^2 (maximum 2 mg) administered IV on Day 1 of each 21-day cycle up to Cycle 6.
16114359|NCT02055820|Drug|Prednisone|Prednisone 100 mg per day orally on Days 1-5 of each 21-day cycle up to Cycle 6.
16114360|NCT02055807|Other|PEEP and recruitment maneuvers|
16114361|NCT02055807|Other|ZEEP (no PEEP nor recruitment maneuver)|
16114362|NCT02055794|Procedure|Suturing of the perineal skin|
16114363|NCT02055794|Procedure|Closing perineal skin with surgical glue|
16114364|NCT02055794|Procedure|No suturing of the perineal skin|
16114365|NCT02055781|Drug|Pacritinib|
16114366|NCT02055781|Drug|Best Available Therapy|
16114368|NCT02055729|Biological|3mm tissue punch biopsy|Bacterial samples will be collected using deep level tissue biopsy using a Steifel punch of 3 mm in diameter (days 0 and 28).
16114369|NCT02055729|Biological|Superficial bedsore sample|Bacterial samples will be taken from the surface of the bedsore via swabbing. (days 0 & 28)
16114370|NCT02055729|Biological|Stool sample|Stool samples will be collected on days 0 and 28.
16114371|NCT02055729|Biological|Urine sample|Urine samples will be collected on days 0 and 28.
16114372|NCT02055716|Drug|Sulforadex|
16114373|NCT02055716|Drug|alpha-cyclodextrin|
16114374|NCT02055703|Drug|E2609|
16114375|NCT02055703|Drug|itraconazole|
16114376|NCT02055703|Drug|rifampin|
16114377|NCT02055703|Drug|digoxin|
16114378|NCT02055703|Drug|donepezil|
16114379|NCT02055690|Drug|Pazopanib|Tyrosine Kinase Inhibitor
16114380|NCT02055690|Drug|Fosbretabulin|Vascular Disrupting Agent
16114381|NCT02055664|Drug|Ropivacaine 0.2%|
16114382|NCT02055664|Drug|Chlorure de sodium 0.9%|
16114383|NCT02055651|Behavioral|Examination and survey|Routine medical examination as required by law and follow-up for lifestyle change program
16114384|NCT02055638|Drug|SRX246|capsules
16114385|NCT02055638|Drug|Placebo|
16114386|NCT02055625|Biological|Mesenchymal stromal cells|Allogenous mesenchymal stromal cells will be injected directly underneath the mucosal lesions at one side under local anesthetic at 2.5-4 million cells/ml. A total of approximately 1.7 ml will be injected divided in 2-3 injections around the lesion. Patients will be followed every second day up to 7 days afterwards and then routinely at 14 days, 1 month, 2 months and 6 months to assess the healing process.
16114387|NCT02055586|Other|fluorine F 18 fluorothymidine|Undergo FLT-PET/MRI
16114388|NCT02055586|Device|positron emission tomography|Undergo FLT-PET/MRI
16114389|NCT02055586|Device|magnetic resonance imaging|Undergo FLT-PET/MRI
16114390|NCT02055573|Other|Ready To Learn (RTL)|See arm description
16114391|NCT02055573|Other|All Babies Cry (ABC)|See arm description
16114392|NCT02055547|Drug|MK-8521 35μg|Single dose 35μg subcutaneous (SC) injection in a treatment period (Part 3, Panel H)
16114393|NCT02055547|Drug|MK-8521 100μg|Single dose 100μg SC injection in a treatment period (Part 1, Panel A) and (Part 2, Panel D)
16114394|NCT02055547|Drug|MK-8521 125μg|Single dose 125μg SC injection in a treatment period (Part 2, Panel E) and (Part 3, Panel H)
16114395|NCT02055547|Drug|MK-8521 150μg|Single dose 150μg SC injection in a treatment period (Part 1, Panel B)
16114396|NCT02055547|Drug|MK-8521 175μg|Single dose 175μg SC injection in a treatment period (Part 1, Panel B)
16114397|NCT02055547|Drug|MK-8521 200μg|Single dose MK-8521 200μg SC injection in a treatment period (Part 1, Panel B)
16114398|NCT02055547|Drug|MK-8521 300μg|Single dose 300μg SC injection in a treatment period (Part 1, Panel A)
16114399|NCT02055547|Drug|MK-8521 50/72μg|MK-8521 50μg SC injection Days 1-5 and 72μg Days 6-10 (Part 2, Panel C)
16114400|NCT02055547|Drug|MK-8521 72/125μg|MK-8521 72μg SC injection Days 1-7 and 125μg Days 8-14 (Part 2, Panel F)
16114401|NCT02055547|Drug|MK-8521 100/150μg|MK-8521 100μg SC injection Days 1-5 and 150μg Days 6-10 SC in a treatment period (Part 2, Panel D)
16114402|NCT02055547|Drug|MK-8521 125/150μg|MK-8521 SC 125μg SC injection Days 1-5 and 150μg Days 6-10 (Part 2, Panel E)
16114403|NCT02055547|Drug|Placebo|Placebo to MK-8521 SC injection in a treatment period (Parts 1, 2, and 3)
16114404|NCT02055534|Other|Nutritional counseling|Nutritional counseling consists in: personalized dietary prescription associated with regular (every 3 weeks) dietetic advise by a registered dietician. Follow-up evaluations take place also during the visits scheduled by the oncologists
16114405|NCT02055534|Other|General dietary advices|General dietary advices are provided. Follow-up evaluations take place during the visits scheduled by the oncologists
16114406|NCT02055521|Procedure|Blood sample, biopsy|
16114407|NCT02055508|Behavioral|Exercise Intervention|
16114408|NCT02055508|Other|Care-Management-Phone-Calls|
16114409|NCT02055482|Drug|Molidustat (BAY85-3934)|BAY85-3934 will be titrated at the scheduled dose control visits to maintain the Hb in the target range of 10.0 to 12.0 g/dL. Available doses include 15, 25, 50, 75, 100, and 150 mg/day OD. Treatment will be for minimum of 6 months to up to a maximum of 36 months.
16114410|NCT02055482|Biological|Darbepoetin|Darbepoetin will be administered according to the local label and titrated at the scheduled dose by intravenous injection. Treatment will be for a minimum of 6 months to up to a maximum of 36 months.
16114411|NCT02055456|Drug|Nandrolone Decanoate|
16114412|NCT02055443|Other|12-lead holter monitor application|"-- The study coordinator will then obtain a 5-minute baseline high resolution (1000 samples/second), 12-lead resting ECG stream using H12+ holter ECG machine (Mortara Instruments, Milwaukee, WI). This ECG will be performed before the subject completed their clinical stress test.
~The patient will then complete the scheduled nuclear stress test that involves exercise treadmill testing followed by single-photon emission computerized tomography (SPECT) scan as per hospital protocols. The exercise treadmill test and SPECT nuclear imaging scan are clinical in nature, and therefore, separate from the research study.
~After completing the scheduled exam, the study coordinator will obtain another 5-minute 12-lead ECG stream prior to removing the chest electrodes but before their nuclear scan."
16114413|NCT02055430|Procedure|percutaneous nephrostomy insertion|The 1st arm was drained by PCN. This was performed under general anesthesia (GA) and fluoroscopic guidance.
16114414|NCT02055430|Procedure|bilateral double J ureteric stent|The 2nd arm was drained by bilateral JJ . This was performed under general anesthesia (GA) and fluoroscopic guidance.
16114415|NCT02055430|Procedure|Definitive stone management|(shockwave lithotripsy, chemodissolution therapy, ureteroscopy or open surgery) for clearance of stones.
16114416|NCT02055417|Behavioral|Personal Approaches to Treatment Choices for HIV|
16114417|NCT02055417|Behavioral|Stress Reduction Skills Program|
16114418|NCT02055404|Device|Delefilcon A spherical contact lens with molded marks|Silicone hydrogel contact lens with 9 different molded marks of varying widths and depths indented into the front surface (S1, S2, S3, S4, S5, S6, S7, S8, and S9). Each lens contained all 9 marks.
16114419|NCT02055404|Device|Etafilcon A toric contact lens|Hydrogel toric contact lens for daily wear, daily disposable use
16114420|NCT02055391|Behavioral|Behavioral Weight Loss|Weekly group meetings addressing behavioral weight loss skills including calorie counting, exercise, behavior modification, environmental changes, and coping with triggers.
16114421|NCT02055391|Behavioral|Enhanced Behavioral Weight Loss|Weekly group meetings that combine behavioral weight loss skills (calorie counting, exercise, behavior modification, environmental changes) with skills to decrease emotional eating by learning ways to manage and cope with emotions without eating.
16114422|NCT02055378|Drug|Atropine|topical 0.125% atropine eye drops
16114423|NCT02055378|Device|auricular acupoint stimulation|Five auricular acupoints (Shenmen, Xin, Yan, Mu 1 and Mu 2) Tapping stimulation was administered by using a 1-mm alloy ball (Magrain®; Sakamura, Kyoto, Japan) three times a day, each time for five minutes.
16114424|NCT02055365|Biological|Hepatitis B Vaccine (Recombinant)|All subjects will receive the standard 3-dose course of Recombivax HB (Merck) - Hepatitis B Vaccine (Recombinant).
16114425|NCT02055352|Drug|Budesonide|Budesonide 400 mcg twice a day via Breezhaler® device
16114426|NCT02055352|Drug|Fluticasone|Fluticasone 250 mcg twice daily via Accuhaler® device
16114427|NCT02055352|Drug|Indacaterol|Indacaterol 150 mcg once daily via Breezhaler® device
16114428|NCT02055352|Drug|Salmeterol|Salmeterol 50 mcg twice daily via Diskus® device
16114429|NCT02055339|Device|Fisher & Paykel heated humidified high flow nasal cannula|
16114430|NCT02055339|Device|InfantFlow/RAM nasal continuous positive airway pressure|
16114431|NCT02055326|Behavioral|Cognitive Behavioral Therapy for Smoking Cessation|one hour weekly for 8 weeks. Cognitive behavioral therapy for smoking cessation
16114432|NCT02055326|Behavioral|Yoga|One hour, twice weekly for 8 weeks of vinyasa yoga
16114433|NCT02055326|Behavioral|Health & Wellness|Lectures, handouts and printed materials on general health and wellness topics including healthy eating, cancer prevention and cardiovascular disease prevention.
16114434|NCT02055300|Drug|LY03005|
16114435|NCT02055300|Drug|Placebo|
16114436|NCT02055300|Other|Meal|
16114437|NCT02055300|Drug|Pristiq|
16114438|NCT02055287|Drug|LY03004|
16114439|NCT02055274|Drug|LY03003|
16114440|NCT02055274|Drug|Neupro|
16114441|NCT02055261|Device|Low frequency DBS of the pedunculopontine nucleus|
16114442|NCT02055196|Biological|carboxylesterase-expressing allogeneic neural stem cells|Given via intracerebral catheter
16114443|NCT02055196|Drug|irinotecan hydrochloride|Given IV
16114444|NCT02055196|Other|laboratory biomarker analysis|Correlative studies
16114445|NCT02055183|Drug|BAT|Noninterventional, retrospective, observational phase 4 patient Registry
16114446|NCT02055170|Drug|finasteride 5mg oral daily|
16114447|NCT02055157|Drug|BMN 111|BMN 111 will be administered daily for 24 months in an open-label sequential dose adjustment fashion.
16114448|NCT02055131|Drug|aspirin|
16114449|NCT02055118|Biological|idursulfase-IT|10mg
16114450|NCT02055118|Other|No IT treatment|Standard of Care
16114451|NCT02055105|Procedure|miRNA in Sepsis|miRNA in Sepsis
16114452|NCT02055079|Drug|Sirolimus|Fixed oral dose of 3 mg sirolimus (blinded) once weekly for 24 months.
16114453|NCT02055079|Drug|Placebo|Fixed oral dose of 3 mg placebo (blinded) once weekly for 24 months.
16114454|NCT02055066|Drug|ARGX-111|
16114455|NCT02055053|Drug|0.5% Bupivicaine|Local anesthetic
16114456|NCT02055027|Other|Comparison between groups|Comparison between the two groups (adherent and non-adherent patients) in order to discover criteria of non-adherence
16114457|NCT02055014|Drug|Liraglutide|
16114458|NCT02055014|Device|Duodenal-jejunal bypass liner - Endobarrier device|
16114459|NCT02054988|Other|caffeine|"After 5 day coffee wash-out period, patients were randomly assigned to caffeine for 10 days. At baseline: 2 cups of coffee consecutively after 5 hour by clopidogrel or prasugrel intake. Afterwards, 3 cups of coffee daily for 10 days.
~Platelet reactivity (expressed as P2Y(12) reaction units (PRU) by the point-of-care VerifyNow assay [Accumetrics, San Diego, California]) was measured at baseline and after 10-days of coffee intake."
16114460|NCT02054988|Other|not caffeine|evaluate the platelet reactivity after 10 days of no caffeine intake
16114461|NCT02054975|Drug|Vitamin D2 + vitamin D3|higher dose vitamin D
16114462|NCT02054975|Drug|Vitamin D3|lower dose vitamin D
16114463|NCT02054949|Drug|N-Acetyl Cysteine (NAC)|NAC will be started at 500 mg by mouth twice daily for the first 2 weeks, then increased to 500 mg in the am and 1000 mg in the pm for week 3, and then increased to 1000 mg am and pm for weeks 4 through 8. Subjects will be maintained at the highest tolerated dose.
16114464|NCT02054936|Drug|Rivaroxaban (Xarelto)|To date there has been little attention to evaluating differences in wound complications following TJA among patients treated with rivaroxaban compared to warfarin.
16114465|NCT02054936|Drug|Warfarin (Coumadin)|To date there has been little attention to evaluating differences in wound complications following TJA among patients treated with rivaroxaban compared to warfarin.
16114466|NCT02054923|Procedure|Implementation of routine videorecording|All screening centres (clusters) assigned to the routine video recording group will receive an appropriate number of video recorders and DVDs for each colonoscopy room. Screening centre coordinators will be responsible for the implementation of routine video recording of all screening colonoscopies (only withdrawal) in the centres. Every three months screening centre coordinators will be asked to send back all recorded DVDs. All the recorded DVDs will be reviewed to verify ceacal intubation and withdrawal time by the PCSP team and then stored.
16114467|NCT02054923|Behavioral|No routine videorecording|Screening centres (clusters) assigned to the control group will not receive video recorders and DVDs but will be allowed to record colonoscopies on demand.
16114468|NCT02054910|Procedure|Celiac Plexus Block|Patients will receive celiac plexus block during endoscopy.
16114469|NCT02054910|Procedure|Sham|Patients will not receive celiac plexus block during endoscopy.
16114470|NCT02054897|Drug|semaglutide|Once weekly, administrated subcutaneously (s.c. under the skin)
16114471|NCT02054897|Drug|placebo|Once weekly, administrated subcutaneously (s.c. under the skin)
16114554|NCT02054325|Drug|Polidocanol with Glucose|An application session 0.2% Polidocanol + 70% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects
16114472|NCT02054884|Drug|Arm A: F16IL2 in combination with paclitaxel|"Intravenous (i.v.) 1 hour infusions of paclitaxel 90 mg/m^2 followed, after 30 min pause, by 3 hour i.v. infusions of F16IL2 35 Mio IU on days 1, 8, 15 of each 28 day cycle.
~Patients will receive 4 week cycles of study therapy for a maximum of 24 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent."
16114473|NCT02054884|Drug|Arm B: Paclitaxel|"Intravenous (i.v.) 1 hour infusions of Paclitaxel 90 mg/m^2 on days 1, 8, 15 of each 28 day cycle.
~Patients will receive 4 week cycles of study therapy for a maximum of 24 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent."
16114474|NCT02054871|Procedure|RIPC|A standard, CE-approved tourniquet cuff will be placed around one arm of the patient. It will then be inflated to a pressure of 200mmHg for 5 minutes. For patients with a systolic blood pressure >185mmHg, the cuff will be inflated to at least 15mmHg above the patient's systolic blood pressure. The cuff will then be deflated and the arm allowed reperfuse for 5 minutes. This will be repeated so that each patient receives a total of 3 ischaemia-reperfusion cycles. Additional, blood and urine samples will be collected on Day 1, Day 2 and Day 3 post procedure.
16114475|NCT02054858|Procedure|RIPC|Remote ischaemic preconditioning (RIPC) is a simple technique whereby brief periods of skeletal muscle ischaemia and reperfusion triggers a period of resistance to ischaemia-reperfusion injury in distant tissues eg. heart or kidney. In this study preconditioning will be performed Immediately prior to the patient undergoing a CT scan. A CE-approved blood pressure cuff will be placed around one arm of the patient. It will then be inflated to a pressure of 200mmHg for 5 minutes. For patients with a systolic blood pressure >185mmHg, the cuff will be inflated to at least 15mmHg above the patient's systolic blood pressure. The cuff will then be deflated and the arm allowed reperfuse for 5 minutes. This will be repeated so that each patient receives a total of 4 ischaemia-reperfusion cycles.
16114476|NCT02054845|Behavioral|Body awareness therapy|"Experimental condition: BEWARE training group The physical and psychosocial elements of the training sessions will be complementary: psychological techniques are used to induce and endure wearing-off and physical techniques are used to improve body awareness to cope with the off-periods.
~Specifically the following techniques will be applied:
~Body scan
~Psychoeducation
~Acceptance Commitment Therapy / Mindfulness skills (sustained attention, concentration, non-reactivity, nonjudging of experience)
~Body Awareness Training
~Exposure training (imaginary exposure to induce response fluctuations)
~Training in cueing techniques to overcome problems with initiation and freezing
~Visual Feedback training
~Relaxation techniques"
16114477|NCT02054845|Other|Physical therapy|Control condition: Treatment as Usual The control group will receive treatment as usual based on the current guidelines for physical therapy in patients with Parkinson's Disease, with the same training schedule of 2x per week for 1,5 hours during 6 weeks. Group treatment will contain exercises for balance, walking, posture, transfers, arm/hand dexterity, strength, flexibility, relaxation and physical condition.
16114478|NCT02054832|Dietary Supplement|Glycosade|
16114479|NCT02054819|Other|Induction chemotherapy and concurrent radiation|Cycle 1: irinotecan 65mg/m2 and cisplatin 30 mg/m2 on Day 1 and 8 Q 21 days Cycles 2-4: irinotecan 65 mg/m2, and cisplatin 30 mg/m2 Day 1 and 8 Q 21 days PLUS radiation therapy 66 Gy/7weeks/33 daily fractions
16114480|NCT02054819|Other|Consolidation: Radiation therapy to metastatic sites|At least 60 Gy total (taking into account a possible 3 Gy x 4 pre-treatment or equivalent) to all metastatic sites. For brain, 2.5 Gy x 14 to whole brain to follow stereotactic radiosurgery (SRS).
16114481|NCT02054806|Biological|Pembrolizumab|IV infusion
16114482|NCT02054793|Drug|Itraconazole|100 mg 200 mg 300 mg
16114483|NCT02054793|Drug|Orteronel|300 mg
16114484|NCT02054780|Behavioral|Trauma-Focused Cognitive Behavioral Therapy|We propose using TF-CBT to address stress related problems (SRP) and reduce HIV risk behaviors. OVC lack behavioral and cognitive skills and intention necessary to use the available information and resources to prevent HIV. For example, internalizing problems are related to HIV risk through low self-efficacy, poor assertiveness skills, and reduced ability to negotiate safe sex. Given evidence on the link between abuse/trauma and elevated HIV risk, researchers have called for overlap between evidence-based mental health treatments like TF-CBT and HIV prevention programs. Some studies have found that skills-oriented interventions reduced HIV-risk behaviors among minority and troubled youths. An intervention study using CBT increased condom use and decreased high-risk sexual behaviors among runaway youths in a short-term follow-up evaluation. However, these studies were done in Western countries; their relevance to OVC in Africa is unproven.
16114485|NCT02054780|Behavioral|Psychosocial Counseling|"The curriculum Psychosocial Care and Counseling was developed for HIV Infected Children and Adolescents. The goal is to enable health care providers to provide safe supportive counseling and support services to HIV infected youth and their families. The course materials are designed to be adapted to different cultures and needs. The 14 modules cover child development, family systems, communicating with children, disclosure and adherence and legal/ethical issues. The course teaches basic counseling skills with children such as listening and play. It explores and challenges barriers to care such as caregivers' fear and reluctance to disclose an HIV positive diagnosis to a child, discussing adolescent sexuality, and practical issues such as inadequate legislation governing child rights. The curriculum was adapted for Zambia and endorsed by the MoH."
16114486|NCT02054767|Drug|Intervention: inferior alveolar nerve block injection|-22 patients received inferior alveolar nerve block injections of 3.6 mL (equivalent to 2 cartridges)
16114487|NCT02054754|Drug|Dexanabinol Dose Level 1|Oral formulation of dexanabinol
16114488|NCT02054754|Drug|Dexanabinol Dose Level 2|Oral formulation of dexanabinol
16114489|NCT02054754|Drug|Dexanabinol Dose Level 3|Oral formulation of dexanabinol
16114490|NCT02054754|Drug|Dexanabinol Dose Level 4|Oral formulation of dexanabinol
16114491|NCT02054754|Drug|Dexanabinol Dose Level 5|Oral formulation of dexanabinol
16114492|NCT02054754|Drug|Placebo|
16114493|NCT02054741|Other|Comprehensive Geriatric Assessment|Complete geriatric assessment
16114494|NCT02054741|Other|Quality-of-Life Assessment|Ancillary studies
16114495|NCT02054741|Other|Survey Administration|Ancillary studies
16114551|NCT02054351|Drug|IMAB027|Stage 1 (Intrapatient dose escalation): The starting dose is set to 1 mg/m2, followed by 10 mg/m2, 30 mg/m2 and 100 mg/m2 Stage 2 (Interpatient dose escalation): 4 dose level 100 mg/m2, 300 mg/m2, 600 mg/m2, 1000 mg/m2 Extension period: 4 dose level 100 mg/m2, 300 mg/m2, 600 mg/m2, 1000 mg/m2
16114641|NCT02053753|Drug|Denosumab CP2|Denosumab produced by a process referred to as CP2, administered subcutaneously.
16114496|NCT02054728|Other|RHC and IMT|"Eligible patients subjected to RHC will be instructed on how to do RMT using the Threshold IMT® two days in advance. RMT will be conducted with 20-30% of individual inspiratory muscle strength, which will be measured beforehand. A single training session consists of 7 cycles with 2 min inspiratory training each, followed by a 1 min break (total duration 21 min).
~The actual intervention consists of inspiratory muscle training (IMT) during right-heart catheterization for at least 2 min or as long as is necessary to measure all specified parameters."
16114497|NCT02054715|Behavioral|print educational intervention|print educational intervention
16114498|NCT02054715|Behavioral|multimedia psychoeducational intervention|multimedia psychoeducational intervention
16114499|NCT02054702|Drug|Brexpiprazole|Treatment (6 weeks) Up to 4 mg/day, once daily dose, tablets, orally
16114500|NCT02054702|Drug|Aripiprazole|Up to 20 mg/day, once daily dose, tablets, orally
16114501|NCT02054689|Radiation|Fractionated Stereotactic Radiosurgery|SRS SBRT CyberKnife Trilogy True Beam Radiosurgery
16114502|NCT02054676|Radiation|Cone-Beam Computed Tomography preoperative evaluation.|"Procedure: Cone-beam computed tomography (CBCT) preoperative evaluation (e.g. i-CAT, Imaging Sciences International, Hatfield, Pennsylvania, USA). CBCT voxel size is about 0,2 - 0,25 mm . Manufacturer recommended software is used. CBCT evaluation of partially edentulous jaw segments are made during preoperative stage (see Appendix 1):
~Non aesthetic and aesthetic zone edentulous jaw segment parameters (height, width, length, mandibular canal walls identification/jawbone quality type visual identification) evaluation;
~Every edentulous jaw segment parameter should be graded following: Type I (low risk), Type II (moderate risk), Type III (high risk).
~All graded measurements provide overall risk evaluation for implant treatment in non aesthetic and aesthetic zone without aesthetic parameters evaluation. Dental implant is selected if surgery is possible."
16114503|NCT02054676|Procedure|Intraoperative edentulous jaw segment parameters evaluation.|"Surgery is planned preliminary according to preoperative stage edentulous jaw segment evaluation results.
~Intervention related study parameters are provided on Appendix 2. Aesthetic parameters related to implant treatment success are evaluated after mucoperiosteal flap elevation: alveolar ridge vertical position, mesial and distal interproximal bone peak height (in the aesthetic zone).
~The additional parameters (non aesthetic) are evaluated after dental implant osteotomy preparation and implant placement:
~implant drill slippage deeper than planned;
~implant threads coverage;
~etc."
16114504|NCT02054676|Device|Endosseous dental implant placement.|"Endosseous dental implant (e.g. Bone Level SLA implant, Straumann AG, Basel, Switzerland) is placed if possible during intraoperative stage according to study protocol in the aesthetic or non aesthetic zone edentulous jaw segment. Optimally positioned dental implant is surrounded by at least 1 mm of bone for successful treatment outcome in the non aesthetic zone.
~Aesthetic zone implant is placed in the optimal three dimensional position. It is surrounded by bone at least 1 mm from lingual side and at least 2 mm from buccal side for successful treatment outcome.
~Dental implant apex is at least 2 mm away from anatomically important jaw vital structures.
~Dental implant parameters (length, width) are individual (depends on edentulous jaw segment parameters).
~Bone and soft tissue augmentation are made if necessary after dental implant placement."
16114505|NCT02054676|Radiation|Dental implant position evaluation.|"Periapical radiograph (e.g. Kodak RVG 6100 Intraoral Digital Imaging System, Carestream Health, Rochester, NY) evaluation is necessary (Appendix 2) to examine implant apex distance to anatomically important vital structures (possible injury) (mandibular canal, nose base) during early postoperative stage.
~Digital periapical radiographs are used to assess the edentulous jaw segment after implant placement. The long cone paralleling technique should be used for taking periapical X-ray (prevention of possible creation of foreshortening and elongation).
~Postoperative patient's neurosensory evaluation is necessary to assess possible inferior alveolar nerve and lingual nerve injury. After finishing of local anaesthesia patient should be contacted and if there are some sensory deficit complains, patient should be examined."
16114506|NCT02054676|Drug|Medications.|"Patients will be given amoxicillin 500mg for every 8 hours or clindamycin 300mg for every 8 hours for 7 - 10 days after surgery.
~Patients will be given Ibuprofen 600mg every 12 hours for pain relief following surgery at least for first three days as needed.
~Patients will be given chlorhexidine 0,12% mouth rinse at least every 8 hours starting 24 hours after surgery for 14 days."
16114507|NCT02054676|Procedure|Late postoperative soft tissue evaluation.|"Mesial and distal papillae appearance, vertical soft tissue deficiency (Appendix 3) evaluation during late postoperative stage is necessary for classification accuracy assessment during final single-tooth implant crown placement in the region of aesthetic zone (both parameters are evaluated) and non aesthetic zone (soft tissue vertical deficiency) edentulous jaw segment.
~The time after surgery is case depending before provisional and final crown placement.
~Peri-implant soft tissue conditioning is recommended with screw retained provisional single-tooth implant crown for approximately 4 - 8 weeks.
~Healing abutment placement after dental implant osseointegration is not recommended because of the treatment time saving."
16114508|NCT02054663|Drug|Clopidogrel|Patients on ticagrelor following an acute coronary syndrome, being transitioned to clopidogrel will be randomized to either a one time 600mg bolous dose of clopidogrel followed by 75mg daily or just starting at 75mg daily without a bolous dose.
16114509|NCT02054650|Other|Osteopathic Manual Treatment (OMT)|Osteopathic Manual Treatment (OMT) is a system of hands-on techniques used by osteopathic physicians to increase function and reduce pain.
16114510|NCT02054650|Other|Sham OMT|Sham OMT involves hand contact, active and passive range of motion, and sham techniques that simulate OMT, but that utilize such maneuvers as light touch, improper patient positioning, purposely misdirected movements, and diminished provider force.
16114511|NCT02054637|Drug|Lanreotide|
16114512|NCT02054624|Behavioral|Lifestyle intervention|"The weight-loss treatments will include two phases. Phase 1 will last 4 months and Phase 2 will last 12 more months.
~Phase 1 will be 4 months of weight loss treatment
~Phase 2 will be 12 months of follow-up contact by group telephone call.
~The participants will learn about nutrition, physical activity, and safe methods to lose weight during Phase 1.
~During Phase 2 participants will receive two phone calls per month from their group leader for the first 6 months, and one phone call per month for the next 6 months."
16114552|NCT02054338|Drug|Vinflunine+Gemcitabine|Vinflunine 320 mg/m² IV on day 1 and.Gemcitabine 1000 mg/m² on days 1 and 8 of each cycle repeated every 3 weeks
16114553|NCT02054338|Drug|Paclitaxel+Gemcitabine|paclitaxel 175 mg/m² on day 1 plus gemcitabine 1250 mg/m² on days 1
16114992|NCT02050906|Other|questionnaire administration|Ancillary studies
16114513|NCT02054624|Behavioral|Health education control|"The weight-loss treatments will include two phases. Phase 1 will last 4 months and Phase 2 will last 12 more months.
~Phase 1 will be 4 months of weight loss treatment
~Phase 2 will be 12 months of follow-up contact by email.
~The participants will learn about nutrition, physical activity, and safe methods to lose weight during Phase 1.
~During Phase 2 participants will receive a specially prepared newsletter two times per month. The newsletter will contain educational information about proper eating and physical activity. The newsletters will include low-fat and low-calorie recipes, along with tip sheets that describe strategies to help them maintain lost weight."
16114514|NCT02054624|Behavioral|Individual|"The weight-loss treatments will include two phases. Phase 1 will last 4 months and Phase 2 will last 12 more months.
~Phase 1 will be 4 months of weight loss treatment
~Phase 2 will be 12 months of follow-up contact by on-on-one telephone call.
~The participants will learn about nutrition, physical activity, and safe methods to lose weight during Phase 1.
~During Phase 2 participants will receive two phone calls per month from their group leader for the first 6 months, and one phone call per month for the next 6 months."
16114515|NCT02054624|Behavioral|All Groups|All participants will receive the following: Questionnaires, height, weight, waist measurement, blood pressure, heart rate, electrocardiogram, blood sample, urine sample, urine pregnancy test (for females only), 400 meter walking test
16114516|NCT02054611|Other|Online Educational Module|A descriptive video detailing the diagnosis of ARDS according to the Berlin Definition, along with online educational materials available for review.
16114517|NCT02054611|Other|Evaluation First (Placebo)|The respondents will view the descriptive video detailing the diagnosis of ARDS according to the Berlin Definition, along with online educational materials available for review only after they have completed the evaluation.
16114518|NCT02054598|Behavioral|Decision aid and navigation|Patients in the intervention group will receive a combined intervention consisting of a CRC screening decision aid and assistance from a trained patient navigator.
16114519|NCT02054585|Other|NaCl 0.9%|"Children will be included in each group in a randomized way using SAS (Statistical Analysis System) program.
~Intervention: In this arm children will receive 20 ml/kg bolus of IV NaCl 0.9% The bags will be identical and the content will be 1 liter. This way if a second bolus is administrated before hospitalization or discharge is decided, the child will still receive the same fluid."
16114520|NCT02054585|Other|NaCl 0.9 +5% dextrose|"Children will be included in each group in a randomized way using SAS (Statistical Analysis System) program.
~Intervention: In this arm children will receive 20 ml/kg bolus of IV NaCl 0.9% + 5% dextrose. The bags will be identical and the content will be 1 liter. This way if a second bolus is administrated before hospitalization or discharge is decided, the child will still receive the same fluid."
16114521|NCT02054572|Drug|[¹⁴C]Etelcalcetide|750 nCi of [¹⁴C]etelcalcetide formulated as a single 10 mg dose of etelcaletide in 2 mL liquid solution for bolus intravenous (IV) administration at the end of hemodialysis.
16114522|NCT02054559|Drug|R-CHOP|R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone (or prednisolone))
16114523|NCT02054559|Radiation|Radiotherapy|
16114524|NCT02054520|Drug|HyperAcute®-Melanoma (HAM) Immunotherapy|
16114525|NCT02054520|Drug|Ipilimumab|
16114526|NCT02054520|Drug|Pembrolizumab|
16114527|NCT02054520|Drug|Nivolumab|
16114528|NCT02054507|Behavioral|Cognitive evaluation (Wechsler IV tests)|Children born prematurely in a level III referral Center will undergo psychometric evaluation at 8 to 11 years of age by routine test (WISC IV). The relationship between cognitive scores and neonatal characteristics will be determined and compared with the results of schoolmate control children, born at term.
16114529|NCT02054481|Drug|BI 655066|Medium dose
16114530|NCT02054481|Drug|BI 655066|High dose
16114531|NCT02054481|Drug|Ustekinumab|
16114532|NCT02054481|Drug|BI 655066|Low dose
16114533|NCT02054468|Drug|Single-Shot Propofol|Single-shot propofol induction dose (1.5-2.5mg/kg body mass)
16114534|NCT02054468|Drug|30min infusion Propofol|30min of propofol infusion (4-6mg/kg/h)
16114535|NCT02054468|Drug|Remifentanil infusion|Remifentanil infusion (0.1-0.2µg/kg/min)
16114536|NCT02054468|Drug|Rocuronium (0.07mg/kg/body mass)|Rocuronium (0.07mg/kg/body mass)
16114537|NCT02054468|Drug|Rocuronium (0.1mg/kg/body mass)|Rocuronium (0.1mg/kg/body mass)
16114538|NCT02054468|Drug|Rocuronium (0.15mg/kg/body mass)|Rocuronium (0.15mg/kg/body mass)
16114539|NCT02054468|Drug|Rocuronium (0.2mg/kg/body mass)|Rocuronium (0.2mg/kg/body mass)
16114540|NCT02054468|Drug|Rocuronium (0.3mg/kg/body mass)|Rocuronium (0.3mg/kg/body mass)
16114541|NCT02054468|Drug|Rocuronium (0.45mg/kg/body mass)|Rocuronium (0.45mg/kg/body mass)
16114542|NCT02054455|Dietary Supplement|Lactobacillus paracasei F19|25x10E9 live bacterial cells for 3 days/week for 6 months
16114543|NCT02054455|Dietary Supplement|Placebo|Placebo will consist of a preparation similar to that of probiotic but with no added microorganisms.
16114544|NCT02054442|Drug|Cetuximab|We will perform a randomized phase II study to investigate in first line if the addition of cetuximab to MTX is beneficial, i.e. improvement in the PFS, for the patient.
16114545|NCT02054442|Drug|Methotrexate|
16114546|NCT02054429|Drug|Insulin|Intensive Insulin Therapy (IIT) will be given to you by two IV infusions. The insulin infusion will be started immediately after you are moved to the intensive care unit (ICU) after endovascular therapy and continued for 48 hours
16114547|NCT02054416|Device|ArtAssist© Device|The study intervention will consist of one hour of IPC with the ArtAssist© device to the remaining leg, three times a day for a three month period. We will obtain the usage data from the device when the subject returns the device (the device has an internal device that stores the usage data) to evaluate subject compliance.
16114548|NCT02054377|Other|Tai chi|"Tai Chi, a Chinese form of mindful exercise, may help alleviate CF symptoms, encourage active self-management and provide a practical way to relieve and manage stress for patients and carers. It involves gentle physical exercises, combined with breathing techniques and mindful awareness.
~It will be taught by qualified instructors either face to face in the participant's home or over videoconferencing technology e.g. Skype.
~A DVD of the Tai Chi was developed in Phase 1 which was successful for teaching adults, and will be used here, along with a child-friendly DVD. This will be filmed with and aimed at children aged 6-18. Teaching support materials, incorporating child-specific guidance such as animal-based Tai Chi movements, will be prepared for use in conjunction with the DVD."
16114555|NCT02054325|Drug|Glucose|An application session 75% Glucose to treat reticular veins of the lower limb selected, with a maximum volume of 5 ml. Return to a week to investigate the adverse effects and 2 months for proof of efficacy and adverse effects
16114556|NCT02054312|Behavioral|Family Based Interpersonal Psychotherapy (FB-IPT)|
16114557|NCT02054312|Behavioral|Client Centered Therapy (CCT)|
16114558|NCT02054299|Drug|Drug application Amitriptyline|Amitriptyline: 25 mg, single oral application
16114559|NCT02054299|Drug|Drug application Desvenlafaxine|Desvenlafaxine: 50 mg, single oral application
16114560|NCT02054299|Drug|Drug application Sumatriptan|Sumatriptan: 50 mg, single oral application
16114561|NCT02054299|Drug|Drug application Proguanil|Proguanil: 200mg, single oral application
16114562|NCT02054299|Drug|Drug application Fenoterol|Fenoterol: 180 mcg, single intravenous application
16114563|NCT02054299|Drug|Drug application Thiamine|Thiamine: 200mg, single oral application
16114564|NCT02054286|Biological|THV01-1|Intramuscular injection of THV01-1 (week 0)
16114565|NCT02054286|Biological|THV01-2|Intramuscular injection of THV01-2 (week 8)
16114566|NCT02054286|Biological|Placebo|Intramuscular injection of placebo matching THV01-1 and THV01-2
16114567|NCT02054260|Drug|Surgicel|
16114568|NCT02054247|Device|ultrasound|a frequency of 1 megahertz and with an intensity of 1 W/cm2, 5 days a week for a total of 15 sessions
16114569|NCT02054247|Device|pulsed ultrasound|a frequency of 1 megahertz and with an intensity of 1 W/cm2 and a pulsed mode duty cycle of 1:4, 5 days a week for a total of 15 sessions
16114570|NCT02054247|Device|placebo ultrasound|same ultrasound device as described above seemed to be working but without delivering any output, 5 days a week for a total of 15 sessions
16114571|NCT02054221|Procedure|myoectomy|The scheme of Extended septal myectomy: Two parallel incisions were made into the septal bulge and connected to remove the muscle mass. Myectomy was extended to the base of the papillary muscles, when midseptal thickening was present. The papillary muscles were grasped and pushed medially to visualize the abnormal connections between the papillary muscles and the anterior wall of the ventricle. A blade was used to divide the thickened abnormal attachments. A pituitary rongeur may be used to resect a portion of the junction of the papillary and lateral wall. This reduces the diameter of the papillary muscle and allows for posterior displacement of the anterior mitral leaflet. Division of abnormal attachments and thinning of the papillary muscles is critical for the treatment of SAM.
16114572|NCT02054221|Procedure|Mitral valve surgery|41 patients will be performed mitral valve replacement with complete excision of the subvalvular apparatus.
16114573|NCT02054221|Procedure|Mitral valve surgery|41 patients will be performed mitral valve repair. Results of mitral valve repair will be more appreciated intraoperatively. In case of unsatisfactory MV repair will reconnect the device artificial circulation and mitral valve replacement. There after, patients will be moved to the first group.
16114574|NCT02054208|Biological|human umbilical cord blood derived mesenchymal stem cells|"Low dose: 1 x 10^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4 week intervals
~High dose: 3 x 10^7cells/2mL 3 repeated intraventricular administrations via an Ommaya Reservoir at 4 week intervals"
16114575|NCT02054208|Other|Normal saline 2mL|Intraventricular administrations of 2mL Normal Saline at 4 week intervals via an Ommaya Reservoir, for a total of 3 administrations
16114576|NCT02054195|Behavioral|Training|Training model is consist of effort to provide intra uterine device post placental by organising a special guided training model for post-placental IUD insertion by pushing the head of IUD using index and middle finger close enough to fundal part of uterus to prevent expulsion.
16114577|NCT02054195|Behavioral|No Training|Control of Training model is without training on effort of pushing the head of IUD using index and middle finger to uterine fundus.
16114578|NCT02054182|Drug|Vitamin D|Vitamin D 2 500 IU daily from enrolment (within 24 hours of hospitalization) until discharge from hospital
16114579|NCT02054156|Drug|azithromycin|3 times weekly, oral suspension, 10 mg/kg/dose up to 500 mg, for 18 months
16114580|NCT02054156|Drug|placebo|3 times weekly, oral suspension, volume-matched to azithromycin, for 18 months
16114581|NCT02054156|Drug|Tobramycin solution for inhalation|300 mg, twice daily for 28 days when respiratory cultures are found positive for Pa at study visits for 18 months
16114582|NCT02054143|Procedure|Partial pressure of CO2 at the end of an exhaled breath|Three previously defined EtCO2 levels (partial pressure of CO2 at the end of an exhaled breath) were adjusted during anesthesia.
16114583|NCT02054143|Drug|Sevoflurane|Sevoflurane was administered to all patients at 1 minimal alveolar concentration (MAC) during the whole operation.
16114584|NCT02054130|Drug|Placebo|Participants received placebo matched to MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
16114585|NCT02054130|Drug|MEDI9929 70 mg|Participants received 70 milligram (mg) of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
16114586|NCT02054130|Drug|MEDI9929 210 mg|Participants received 210 mg of MEDI9929 subcutaneously once every 4 weeks from Day 1 to Week 48 along with subcutaneous placebo once every 4 weeks from Week 2 to Week 50.
16114587|NCT02054130|Drug|MEDI9929 280 mg|Participants received 280 mg of MEDI9929 subcutaneously once every 2 weeks from Day 1 to Week 50.
16114588|NCT02054117|Other|Intracerebral Hemorrhage|Spontaneous intracranial or intraparenchymal hemorrhage that occurred in a supratentorial location.
16114589|NCT02054104|Biological|H1299 cell lysates|H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and NED.
16114590|NCT02054104|Drug|Cyclophosphamide|50 mg PO BID for 7 days prior to the first dose of vaccine and then on days 8 through 14, and 22 through 28 of each treatment cycle.
16114591|NCT02054104|Drug|Celecoxib|400 mg PO BID for 7 days prior to the first dose of vaccine and then on days 1 through 28 of each treatment cycle.
16114592|NCT02054104|Biological|Iscomatrix adjuvant|H1299 cell lysate with iscomatrix adjuvant vaccine via subcutaneous injections once every cycle (cycle=28 days) for 6 cycles total. Additional 2 injections for patients with immunologic response and NED.
16114642|NCT02053740|Drug|Add R-S-Y-R-T (500 mg 3 times per day) for 6 months|
16114643|NCT02053740|Drug|Routine western medicine|
16114940|NCT02051335|Drug|Donepezil placebo|Donepezil placebo-matching overencapsulated tablets
16114593|NCT02054091|Dietary Supplement|Bovine colostrum|The BC powder to be used in this study is donated from a Danish company, Biofiber Damino. The raw colostrum used for production is collected within 1-2 milking from healthy Danish dairy cows (Danish Holstein). Antibiotic residues are screened upon collection and those tested positive are not used for production. Intact colostrum is pasteurized, low temperature spray-dried, and sterilized by γ-irradiation.
16114594|NCT02054078|Drug|Bevacizumab|Bevacizumab200mg by intrapleural administration
16114595|NCT02054078|Drug|Pulvis talci|Pulvis talci 4g by intrapleural administration
16114596|NCT02054065|Other|CAUTI Decision Support|Decision support used to prevent Catheter Associated Urinary Tract Infections
16114597|NCT02054052|Drug|Bevacizumab|Bevacizumab 100 mg, intrapleural injection treating MPE after the drainage of MPE
16114598|NCT02054039|Device|Incentive spirometry (IS)|Mechanical devices activated by an inspiratory effort, which is viewed by the elevation of a plateau or balls in a transparent cylinder having a calibrated scale that displays the inspired flow.
16114599|NCT02054039|Device|Breath Stacking (BS)|Equipment with a one-way valve that masks and promotes the accumulation of successive inspiratory volumes, preventing expiration
16114600|NCT02054026|Behavioral|Reducing the Risk|
16114601|NCT02054013|Procedure|Prostatic artery embolization|
16114602|NCT02054013|Procedure|monopolar transurethral prostatectomy|
16114603|NCT02054000|Drug|Tirofiban|Intracoronary administering of Tirofiban
16114604|NCT02054000|Other|Placebo|Intracoronary serum physiologic
16114605|NCT02053987|Other|Intensive rehabilitation in the home.|
16114606|NCT02053974|Drug|Spironolactone|Spironolactone
16114607|NCT02053974|Other|Placebo|Placebo
16114608|NCT02053961|Device|Deep Transcranial Magnetic Stimulation|1Hz dTMS real treatment
16114609|NCT02053961|Device|Deep Transcranial Magnetic Stimulation|1Hz dTMS SHAM treatment
16114610|NCT02053948|Procedure|Pursestring Wound Closure|
16114611|NCT02053948|Procedure|Gunsight Skin Incision and Closure Technique|
16114612|NCT02053935|Drug|Dopamine|Each subject will receive a priming dose of dextrose 20% to increase their glucose concentration by 125 mg/dl in the first 15 minutes. Then they will receive variable rates of dextrose 20% infusion to maintain glucose level at 180-220 mg/dl. Then, dopamine (200mg/250ml) will be titrated up to 5 mcg/kg/min with care not to increase blood pressure greater than 160 systolic. Dopamine will be infused for 3 hours.
16114613|NCT02053922|Drug|Syntocinon|Syntocinon ampoules (10 IU Oxytocin). (Novartis Pharma, Egypt) One ampoule 10 IU diluted in 10 ml normal saline and administered slowly (over 30- 60 seconds) intravenously just after delivery of the neonate during CS, followed by an intravenous drip of 20 IU oxytocin in 500 ml saline over 4 hours.
16114614|NCT02053922|Drug|Carbetocin|Carbetocin (Ampoule 100 μg/ml) . [Pabal, Marketing Authorization Holder: Ferring GmbH (Gesellschaft mit beschränkter Haftung), Kiel ,Germany. Manufactured by DRAXIS Pharma , a division of specialty Pharmaceuticals Inc. Montreal ,Canada] ,diluted in 10 ml normal saline and administered slowly (over 30- 60 seconds) intravenously just after delivery of the neonate during CS.
16114615|NCT02053922|Drug|Misoprostol|Misoprostol (200 mcg Tablet) [Misotac, Sigma Pharmaceutical Industries, SAE, Egypt] Two tablets (400 mcg) in the buccal space just after delivery of the neonate during CS.
16114616|NCT02053909|Drug|Aspirin|
16114617|NCT02053909|Drug|Ticagrelor|
16114618|NCT02053883|Drug|Cethrin (BA-210)|High or low doses of Cethrin administered extradurally in a fibrin sealant during spinal decompression/stabilization surgery.
16114619|NCT02053883|Drug|Placebo|Fibrin sealant alone administered extradurally during spinal decompression/stabilization surgery.
16114620|NCT02053870|Other|Physiotherapy+conventional treatment|Patients will be treated with daily medication prescribed by the physician, during 3 weeks. Additionally, they will be involved in 9 sessions (3 times a week during 2 weeks) of respiratory physiotherapy including breathing retraining and chest clearance techniques, exercises for thoracic mobility, expansion and flexibility, cardiorespiratory exercise training and education about the disease.
16114621|NCT02053870|Drug|Conventional treatment|Patients will be treated with daily medication prescribed by the physician, during 3 weeks.
16114622|NCT02053857|Dietary Supplement|RUTF|
16114623|NCT02053857|Dietary Supplement|RUTF-P|
16114624|NCT02053857|Drug|Amoxicillin|
16114625|NCT02053844|Other|lottery for tool users to win a $500 prize|Intervention group is eligible to enter a monthly lottery to win a $500 gift card if they use the tool each month.
16114626|NCT02053844|Other|enhanced promotion of the tool to employers and members|Intervention group also receives extra promotion of the tool through mailings, employer outreach, and automated phone calls
16114627|NCT02053818|Drug|Remifentanil|Randomization to receive Remifentanil (ultrashort acting opioid) as basic opioid in anaesthesia
16114628|NCT02053818|Drug|Sufentanil|Randomization to receive Sufentanil (medium/long acting opioid) as basic opioid in anaesthesia
16114629|NCT02053805|Other|PSA|PSA. Serum & plasma will be stored for future investigations
16114630|NCT02053805|Other|IPSS questionnaire|the validated International Prostate Symptom Score
16114631|NCT02053805|Other|DRE (Digital Rectal Examination )|physical examination for the prostate gland
16114632|NCT02053805|Other|urine flow and residual|The post void residual will be recorded by using ultrasound. Creatinine level will be checked.
16114633|NCT02053805|Procedure|a multiparametric prostate MRI|The MRI will be reported on a 5 point Likert Scale
16114634|NCT02053805|Procedure|trans-rectal ultra-sound guided prostate biopsy|12 core Trans-rectal prostatic biopsy for diagnostic purposes
16114635|NCT02053792|Biological|rIX-FP|Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP)
16114636|NCT02053779|Drug|Triptorelin 0.1mg|Triptorelin 0.1 mg administered subcutaneously 6 days after ovum pick-up (OPU) in IVF/ICSI cycles triggered by triptorelin 0.2 mg followed by hCG 1500 iu the day of OPU.
16114637|NCT02053766|Drug|Sevoflurane|Sevoflurane up to 8% will be administered to study subjects
16114638|NCT02053766|Drug|Dexmedetomidine|Dexmedetomidine (Precedex) infusion starting at 1mcg/ kg/ hr will be administered to study subjects.
16114639|NCT02053766|Drug|Propofol|Propofol up to 50 mcg/ kg/min will be administered to study subjects.
16114640|NCT02053753|Drug|Denosumab CP4|Denosumab produced by a process referred to as CP4, administered subcutaneously.
16115039|NCT02050360|Drug|Sildenafil 40 mg|
16114644|NCT02053727|Drug|Abatacept|Abatacept Injection, 125 mg/Syringe (125 mg/mL), is a sterile solution for SC administration, which contains approximately 126 mg abatacept.
16114645|NCT02053727|Drug|Placebo|
16114646|NCT02053714|Behavioral|Diabetes self-management and education|
16114647|NCT02053688|Device|Astigmatic Correction Lens (Nexis ACCL lenses)|Astigmatic refractive error correction
16114648|NCT02053688|Device|Toric Soft Contact Lenses|astigmatism correction using toric optics
16114649|NCT02053675|Drug|Vasopressin infusion|
16114650|NCT02053662|Procedure|Sample Collection|A collection of donated cancer and normal adjacent tissues, blood and urine which will be prospectively obtained from patients through the Tissue Procurement Shared Resources (TPSR) and The Ohio State University Comprehensive Cancer Center Biospecimen and Biorepository Resource (BBR) as needed.
16114651|NCT02053649|Behavioral|Triple Chronotherapy|triple chronotherapy (TC will consist of bright light therapy, sleep phase advance, and sleep deprivation/restriction
16114652|NCT02053649|Other|Usual Care|UC will consist of medication administered by a perinatal psychiatrist and/or psychotherapy
16114653|NCT02053636|Drug|lucitanib|
16114654|NCT02053610|Drug|obinutuzumab|1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles).
16114655|NCT02053610|Drug|rituximab|375 mg/m^2 rituximab intravenous (IV) infusion on Day 1 of Cycle 1 (Cycle duration is 28 days) then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6.
16114656|NCT02053610|Drug|chlorambucil|Chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle
16114657|NCT02053597|Drug|Doxorubicin|All patients will receive four cycles of doxorubicin (A) (50 mg/m2)
16114658|NCT02053597|Drug|paclitaxel|All patients will receive four cycles paclitaxel (P) (200 mg/m2), given on a three-weekly basis for four cycles, followed by weekly paclitaxel (P) (80 mg/m2) for twelve weeks.
16114659|NCT02053584|Device|Dario™ Blood Glucose Meter|Each subject will undergo a finger prick and also provide a venous blood sample
16114660|NCT02053584|Device|YSI2003|Blood samples will be tested using YSI (gold standard) for comparison to evaluate accuracy.
16114661|NCT02053571|Procedure|TIPS with 3D Overlay|
16114662|NCT02053558|Drug|Systemic lidocaine|Systemic lidocaine group will receive a lidocaine 1.5 mg/kg bolus after induction of anesthesia followed by a 2mg/kg/hr infusion and sham bilateral TAP blocks with normal saline 15mL on each side.
16114663|NCT02053558|Drug|TAP BLOCK with ropivacaine|TAP block group will receive bilateral TAP blocks using ultrasound guidance with 0.5% ropivacaine 15mL on each side and a bolus and infusion of normal saline after induction of anesthesia.
16114664|NCT02053545|Drug|Conditioning Regimen & GVHD Prophylaxis|"Stratum 1 (Refractory disease, relapse after previous transplant): Radiation Therapy (if patient had prior Central Nervous System (CNS) disease), Clofarabine, Melphalan,Thiotepa, Stem Cell Transplant, Cyclophosphamide, Mesna, Tacrolimus and MMF
~Stratum 2 (Myeloid in remission): Radiation Therapy (if patient had prior CNS disease), Busulfan, Fludarabine, Thiotepa, Stem Cell Transplant, Cyclophosphamide, Mesna, Tacrolimus, MMF
~Stratum 3 (Lymphoid in remission): Radiation Therapy (if patient had prior CNS disease), TBI, Fludarabine, Thiotepa, Stem Cell Transplant, Cyclophosphamide, Mesna, Tacrolimus, MMF"
16114665|NCT02053532|Procedure|Positron emission tomography/magnetic resonance imaging|Positron emission tomography/magnetic resonance (PET/MR) imaging using 18-F-fluorodeoxyglucose (FDG) as radio tracer
16114666|NCT02053519|Drug|Active Comparator: Vigantol Oil (Vitamin D3)|Vitamin D Oral oil 100.000iu in 5 mls
16114667|NCT02053519|Drug|Mygliol Oil|Matched placebo comparator
16114668|NCT02053506|Dietary Supplement|Immune-enhancing nutritional beverage|Combination of arginine, glutamine, omega-3 fatty acids, vitamin C and zinc.
16114669|NCT02053506|Dietary Supplement|Probiotics (BB-12)|Probiotics (Bifidobacterium Animalis Lactis, BB-12®, Chr Hansen A/S, Hoersholm, Denmark) will be administered as a strawberry-flavored, powdered candy (1 g). The candy will be packaged in a small foil pouch, and each pouch will contain approximately 1 billion colony forming units (CFU) of BB-12® in powder form.
16114670|NCT02053506|Dietary Supplement|Placebo (for nutritional beverage and probiotic)|Dietary protein at RDA of 0.8 grams•kg-1 body weight•day-1 and a placebo beverage during and after the period of sleep restriction.
16114671|NCT02053493|Drug|Isosorbide Mononitrate|"Dispense phase 1 study drug:
~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg ISMN Week 4: 60 mg ISMN Weeks 5 and 6: 120 mg ISMN
~Dispense phase-2 study drug:
~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg ISMN Week 10: 60 mg ISMN Weeks 11 and 12: 120 mg ISMN"
16114672|NCT02053493|Drug|Placebo|"Dispense phase 1 study drug:
~Weeks 1 and 2: No study drug (baseline) Week 3: 30 mg Placebo Week 4: 60 mg Placebo Weeks 5 and 6: 120 mg Placebo
~Dispense phase-2 study drug:
~Weeks 7 and 8: No study drug (washout) Week 9: 30 mg Placebo Week 10: 60 mg Placebo Weeks 11 and 12: 120 mg Placebo"
16114673|NCT02053467|Other|Champlain BASE eConsult Service|After undergoing registration, which includes orientation and brief training on the use of the service, physicians randomized to intervention arm will be able to submit patient-specific clinical questions to specialists through a secure, web-based application. Specialists are asked to respond within 7 days and, for each eConsult, are able to: (1) provide a recommendation, (2) request more information, or (3) recommend a face-to-face referral. The communication between PCPs and specialists is iterative and the discussion can occur back and forth until, ultimately, the PCP closes the case.
16114674|NCT02053454|Drug|patisiran (ALN-TTR02)|Ascending doses administered by intravenous (IV) infusion
16114675|NCT02053454|Drug|Sterile Normal Saline (0.9% NaCl)|Calculated volume to match active comparator
16114676|NCT02053428|Procedure|percutaneous image-guided gastrostomy|
16114677|NCT02053415|Dietary Supplement|Krill oil low dose|3 capsules krill oil per day
16114678|NCT02053415|Dietary Supplement|Krill oil high dose|9 capsules krill oil per day
16114679|NCT02053402|Drug|Vitamin D|Vitamin D daily for six months
16114680|NCT02053389|Behavioral|DVD Decision Aid|"The decision aid, Discussing the Choice: Talking with your Doctor about Early Stage Prostate Cancer is a DVD modeling patient communication strategies. The DVD includes vignettes with actors depicting patient-physician discussions of prostate cancer treatments. In these vignettes, the patient models communication strategies designed to facilitate patient activation."
16114824|NCT02052115|Behavioral|12 month exercise and weight loss intervention|
16114825|NCT02052102|Radiation|Radiation therapy|
16114681|NCT02053389|Behavioral|Written decision aid|"A written decision aid entitled Making the Choice: Deciding What to Do About Early Stage Prostate Cancer that describes treatment options for early stage prostate cancer."
16114682|NCT02053376|Drug|Regorafenib|regorafenib (120 mg) (160 mg for second and subsequent treatment cycles)orally once daily 21 days (3 weeks) on and 7 days (1 week) off in the 28-day (4-week) cycle.
16114683|NCT02053363|Drug|Tranexamic Acid (Cyklokapron)|
16114684|NCT02053350|Drug|Alanyl-glutamine|Alanyl-glutamine, 44g, taken by mouth daily for 10 days
16114685|NCT02053337|Device|Self adhesive foam dressing|Self adhesive foam dressing
16114686|NCT02053324|Combination Product|AvidinOX/ST2210|One intralesion injection of AvidinOX followed by an intravenous infusion of ST2210
16114687|NCT02053311|Drug|Orteronel|300mg orteronel
16114688|NCT02053311|Drug|Placebo|Placebo
16114689|NCT02053298|Drug|Timolol & Dorzolamide|Topical preservative-free fixed combination of timolol 0.5%+dorzolamide 2% to be applied bid for 1 month
16114690|NCT02053272|Drug|GWP42004|The total dose administered within any 24-hour interval will be two capsules (typically 12 hours apart).
16114691|NCT02053272|Drug|Placebo|The total dose administered within any 24-hour interval will be two capsules (typically 12 hours apart).
16114692|NCT02053259|Behavioral|Adaptive Goals|
16114693|NCT02053259|Behavioral|Reinforcement|
16114694|NCT02053259|Behavioral|Static Goals|
16114695|NCT02053246|Drug|Nebivolol|Nebivolol will be started at 2.5 mg by mouth daily if on a beta-blocker the dose will start at 5mg, and titrated up to 10 mg daily, as tolerated.
16114696|NCT02053233|Device|Walkbot group|"The physiotherapist typed patient's information then Walkbot would adjust itself to this data and the exoskeleton legs lengthen or shorten to the patient. The computer screen would provide information about speed, duration, cadence and distance. The monitor in front of the patient can offer image and feedback during the therapy process for patients.
~The whole Walkbot training process was observed by one physiotherapist and should be always ready to adjust the unloading, duration, speed and guidance force of Walkbot according to patients' different situation such as muscle spasticity, gait quality, labor-consuming and observe the changes of patients' state."
16114697|NCT02053233|Device|Control group|The control group received conventional functional rehabilitation for 40 min/session, 2 sessions/day, 5 days/week for 4 weeks, 40 sessions in all. After 4-week intervention all subjects received conventional physical therapy only, 40 min/day, 5 days/week for 4 weeks. During the test period, general rehabilitation and drug treatment can be done at the same time.
16114698|NCT02053220|Biological|Colo-Ad1|Oncolytic virus
16114699|NCT02053207|Behavioral|Cog-Train Intervention|Twenty-one days prior to surgery, patients will begin self-administering the intervention using an iPad tablet. This intervention will consist with daily sessions of at least 20 minutes of the Cog-Train task (the task and regimen used to obtain robust effects in previous studies by members of our group). Cog-Train is an n-back task - an adaptive working memory computer game that extends players' working memory capacity by getting progressively more difficult as the player's performance increases.
16114700|NCT02053194|Behavioral|Pharmacist-led educational intervention|1) Educational material to participants in the form of a written educational brochure on inappropriate prescriptions that was developed and tested during the EMPOWER study. 2) Evidence-based pharmaceutical opinions sent to the treating physicians.
16114701|NCT02053181|Drug|Cadazolid|Cadazolid was provided as dry powder for oral suspension (Amber glass bottles of 60 mL). The powder was reconstituted with tap water by a pharmacist immediately prior to dispensing to subjects.
16114702|NCT02053168|Device|Resorbable Mesh|Phasix Mesh
16114703|NCT02053155|Behavioral|Computer based patient education|
16114704|NCT02053142|Drug|Acyclovir|Single dose of acyclovir 200mg was given for pk study
16114705|NCT02053142|Drug|Placebo|
16114706|NCT02053129|Other|TB screening Questionnaire|All subjects will be screened with the questionnaire which assesses TB symptoms.
16114707|NCT02053129|Other|Sputum smear and culture (only in HIV negative women who are symptomatic)|specimens for sputum microscopy and culture collected and processed in accordance with WHO TB Infection Control Guidelines
16114708|NCT02053116|Drug|PF-05175157|Tablet, 200 mg, twice daily, 6 weeks
16114709|NCT02053116|Drug|Placebo|Tablet, 0 mg, twice daily, 2 weeks
16114710|NCT02053103|Drug|PF-05175157|Tablet, 200 mg, twice daily, 6 weeks
16114711|NCT02053103|Drug|Placebo|Tablet, 0 mg, twice daily, 6 weeks
16114712|NCT02053090|Behavioral|Group Education and Stretching|
16114713|NCT02053090|Procedure|Group Acupuncture|
16114714|NCT02053064|Genetic|SAF-301|
16114715|NCT02053051|Device|ABC4D|Advanced Bolus Calculator for Type 1 Diabetes (ABC4D) to calculate pre-meal insulin boluses
16114716|NCT02053051|Drug|Novorapid|Multiple daily injections(MDI) of insulin
16114717|NCT02053038|Device|iFR|Treatment guided by instantaneous wave-free ratio
16114718|NCT02053038|Device|FFR|Treatment guided by Fractional Flow Reserve
16114719|NCT02053025|Dietary Supplement|mycoprotein|
16114720|NCT02053025|Dietary Supplement|control protein|
16114721|NCT02053012|Device|PVT-192|PVT-192 Psychomotor Vigilance Task Monitor is a hand-held, self-contained system used for repetitive reaction time measurement.
16114722|NCT02052999|Drug|PAC-14028 cream 1%|Participants received topical PAC-14028 cream 1% twice daily for 8 weeks
16114723|NCT02052999|Other|Vehicle|Participants received topical Vehicle twice daily for 8 weeks
16114724|NCT02052999|Drug|Rozex gel 0.75%|Participants received topical Rozex gel 0.75% twice daily for 8 weeks
16114725|NCT02052986|Other|VASCAZEN|All enrolled subjects will receive 4 capsules daily of VASCAZEN which delivers 3.0 grams of EPA and DHA
16114726|NCT02052973|Other|Propolis varnish|Saliva and oral biofilm will be collected before and in regular times after the application of the propolis varnish. This data will be compared in order to evaluate the probable reduction of Streptococcus mutans in saliva and oral biofilm.
16114727|NCT02052960|Drug|CetuGEX™|60 mg/day 0, 930 mg/day 1, followed by 720 mg i.v. weekly administration
16114728|NCT02052960|Drug|Cetuximab|400 mg/sqm body surface area (BSA) on day 1, followed by 250 mg/sqm BSA i.v. weekly administration
16114729|NCT02052960|Drug|Chemotherapy|Combination of Cisplatin and 5-Fluorouracil (Carboplatin may substitute Cisplatin following the 1st cycle of therapy in case of toxicity)
16114730|NCT02052947|Radiation|SPECT-DaTscan|"Measurement of fixation of DaTscan® in the caudate and lenticular nucleus
~LP (Lumbar Puncture): the LP will follow the last guidelines published in 2011 (Armand Perret-Liaudet is co-author of these guidelines; Perret-Liaudet A. et al, Cerebrospinal Fluid Collection Tubes: a critical issue for Alzheimer Disease diagnosis. Clin Chem, 2012, accepted)."
16114731|NCT02052934|Biological|Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine|Attenuated, Recombinant Double Mutant Heat-Labile Toxin (dmLT) from Enterotoxigenic Escherichia coli (ETEC), LT(R192G/L211A); lot 1575. Subjects in 5 cohorts receive 3 doses ranging from 1 mcg to 50 mcg.
16114732|NCT02052934|Biological|Recombinant Double Mutant Heat-Labile Toxin LT(R192G/L211A) (dmLT) Oral enterotoxigenic Escherichia coli (ETEC) Vaccine|Attenuated, Recombinant Double Mutant Heat-Labile Toxin (dmLT) from Enterotoxigenic Escherichia coli (ETEC), LT(R192G/L211A); lot 1575. Subjects in 5b cohort receive 3 doses of 25 mcg.
16114733|NCT02052921|Procedure|Rectal resection|Surgical rectal resection
16114734|NCT02052921|Other|Observation|
16114735|NCT02052908|Other|Laboratory Biomarker Analysis|Correlative studies
16114736|NCT02052908|Drug|Naproxen|Given PO
16114737|NCT02052908|Other|Placebo Administration|Given PO
16114738|NCT02052882|Biological|romiplostim|
16114739|NCT02052869|Procedure|esophagus intubation|In these patients, automatic pressure waveform analysis is performed during the first three test ventilations on both the tracheal and oesophageal tube. ventilations will be performed by a blinded person. Subsequently, three conventional thoracic pushes will be performed.
16114740|NCT02052843|Behavioral|Steps to Success|
16114741|NCT02052843|Behavioral|Traditional Healthy Families|
16114742|NCT02052830|Behavioral|Wise Guys|Multi-session curriculum delivered in different formats that range in length from 5 to 12 weeks and topics covered include communication and masculinity, dating violence, abstinence and contraception, and sexually transmitted infections.
16114743|NCT02052817|Device|Optimal Medical Therapy Debridement + Toad Brace|
16114744|NCT02052817|Other|Optimal Medical Therapy - Debridement|
16114745|NCT02052791|Drug|nusinersen|Administered by intrathecal (IT) injection
16114746|NCT02052778|Drug|Futibatinib|"oral once daily dosing, 21-day cycle
~Dose escalation: Futibatinb (TAS-120) oral once daily or thrice per week dosing Dose expansion: Futibatinb (TAS-120) oral once daily dosing.
~Phase 2: Futibatinb (TAS-120) oral 20mg once daily dosing"
16114747|NCT02052765|Device|ECG continuous recording (Analyze ST)|During the ajmaline test, continuous ECG recording was forced to record ST shift
16114748|NCT02052752|Drug|3% Benzoyl Peroxide|Test product contained 3% benzoyl peroxide in the form of a gel. It was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
16114749|NCT02052752|Drug|3% Benzoyl Peroxide Placebo|The vehicle gel was similar to the test product except that it did not contain 3% benzoyl peroxide. The vehicle gel served as the negative control and was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
16114750|NCT02052752|Drug|Neutrogena Rapid Clear®|A commercial product containing 2% salicylic acid that reportedly improves acne lesions was applied on participant's face once-daily at approximately the same time on Days 0, 1, 2 and 3.
16114751|NCT02052739|Drug|SAGE-547|Intravenous
16114752|NCT02052726|Biological|C. difficile vaccine with adjuvant|C. difficile vaccine with adjuvant administered at Month 0, 1, and 3.
16114753|NCT02052726|Biological|Placebo|Placebo administered at Month 0, 1, and 3.
16114754|NCT02052726|Biological|C. difficile vaccine with adjuvant|C. difficile vaccine with adjuvant administered at day 1, 8, 30.
16114755|NCT02052726|Biological|placebo|Placebo administered at Day 1, 8, and 30.
16114756|NCT02052713|Drug|Commercially available combination of dutasteride 0.5 mg and tamsulosin HCL 0.4 mg|Commercially available, orange and brown, hard shell capsule, administered orally as a single dose on Day 1 under fasted condition.
16114757|NCT02052713|Drug|Second generation dutasteride 0.5 mg and tamsulosin HCL 0.4 mg combination capsule|Orange and brown, hard shell capsule, administered orally, as a single-dose on Day 1 under fasted condition.
16114758|NCT02052687|Drug|LFX453 H1|LFX453 high dose cream 1
16114759|NCT02052687|Drug|LFX453 L1|LFX453 low dose cream 1
16114760|NCT02052687|Drug|LFX453 H2|LFX453 high dose cream 2
16114761|NCT02052687|Drug|LFX453 L2|LFX453 low dose cream 2
16114762|NCT02052687|Drug|Imiquimod|Imiquimod cream
16114763|NCT02052687|Drug|Placebo 1|Placebo cream 1
16114764|NCT02052687|Drug|Placebo 2|Placebo cream 2
16114765|NCT02052674|Device|Vented urinary drainage system|This group will be catheterized with a vented urinary drainage system. Several data sets will be evaluated to compare the two arms of the study: retained urine volume, the difference (ΔH) in meniscus heights in the dependent loops, time necessary for drainage of dependent loops, and incidence of bacteriuria.
16114766|NCT02052674|Device|Non-vented urinary drainage system|This group will be catheterized with a non-vented urinary drainage system. Several data sets will be evaluated to compare the two arms of the study: retained urine volume, the difference (ΔH) in meniscus heights in the dependent loops, time necessary for drainage of dependent loops, and incidence of bacteriuria.
16114767|NCT02052661|Biological|Engerix™-B Kinder|Single dose administered intramuscularly in deltoid region of non-dominant arm.
16114768|NCT02052648|Drug|Indoximod|
16114769|NCT02052648|Drug|Temozolomide|
16114770|NCT02052648|Drug|Bevacizumab|
16114771|NCT02052648|Radiation|Stereotactic Radiation|
16114772|NCT02052635|Drug|ticagrelor|Single loading dose of 180mg of ticagrelor at time of bivalirudin administration. Beginning 12 hrs following study drug administration, all pts in the ticagrelor arm will receive ticagrelor 90 mg (maintenance dose) approximately every 12 hrs until Follow-up telephone contact.
16114773|NCT02052635|Drug|clopidogrel|Single loading oral dose of 600 mg of clopidogrel will be given at time of bivalirudin administration. Beginning 4 hrs following study drug administration, all pts in the clopidorgrel arm will receive ticagrelor 180 mg for the loading dose, followed by 90 mg maintenance dose approximately every 12 hours until the Follow-up telephone contact.
16114774|NCT02052609|Drug|KHK4827 140mg SC|Experimental1:KHK4827 140mg subcutaneous injection
16114775|NCT02052609|Drug|KHK4827 210mg SC|Experimental2:KHK4827 210mg subcutaneous injection
16115040|NCT02050360|Drug|Sildenafil 80 mg|
16114776|NCT02052596|Biological|Herpes Zoster vaccine GSK 1437173A|2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm at Visit Day 0 and Visit Month 2 for Co-Ad group and at Visit Month 2 and Visit Month 4 for Control group.
16114777|NCT02052596|Biological|Boostrix|1 dose administered intramuscularly (IM) in the deltoid region of the dominant arm at Visit Day 0 for both Co-Ad and Control groups.
16114778|NCT02052583|Procedure|therapeutic hypothermia at 32 ° C|
16114779|NCT02052583|Procedure|therapeutic hypothermia at 34 ° C|
16114780|NCT02052557|Drug|Bupivacaine|30ml of bupivacaine were injecting into the subcutaneous tissue at the incision sites after surgery in the OR
16114781|NCT02052557|Drug|Bupivacaine liposome suspension|30ml of Bupivacaine liposome injectable suspension were injecting into the subcutaneous tissue at the incision sites after surgery in the OR
16114782|NCT02052531|Drug|PAC-14028|Participants received topical PAC-14028 cream 0.3 or 1% twice daily for 4 weeks
16114783|NCT02052531|Other|Vehicle|Participants received topical Vehicle twice daily for 4 weeks
16114784|NCT02052518|Behavioral|Experimental|These participants will receive the enhanced intervention including decision support and problem solving skills in addition to the standard of care for the individuals in the Nuturing Family Network Home Visition Program
16114785|NCT02052505|Procedure|Medication review|The medication review will be based on the nurses experience, clinical knowledge and predefined categories of inappropriate prescribing
16114786|NCT02052492|Drug|EF-022 (Modified Vitamin D Binding Protein Macrophage Activator)|
16114787|NCT02052479|Other|Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT)|
16114788|NCT02052440|Drug|Baclofen|Treatment arm: baclofen 10mg tid
16114789|NCT02052440|Drug|Placebo|Sugar pill by mouth three times daily
16114790|NCT02052427|Device|Celution System|ADRCs processed by the Celution System for reintroduction into the myocardium
16114791|NCT02052427|Device|Placebo|Physiological solution made of Lactated Ringers solution and a small amount (<1mL) of autologous blood
16114792|NCT02052414|Drug|Gabapentin ER|"Patient who are on gralise will report efficacy by rating his or her pain rating on a digital pain scale (11 points) from 0 to 10 on each scheduled clinical visits, which will be compared to their pain level at baseline.
~In addition, patients will also record the doses and any adverse effects that might arise during the trial in a diary provided by the study. All information will be recorded in a paper diary that will be followed by coordinator during each follow up visits."
16114793|NCT02052401|Other|Domiciliary Intervention|Two time domiciliary application of an standardized protocol consisting of: a) evaluation of pharmacological and non pharmacological therapies adherence. b) application of a Checklist of home safety measures. c) development of a patient oriented occupational routine d) education in strategies for elderly global stimulation e) education strategies for identifying red flags and for correct use of health services.
16114794|NCT02052388|Drug|Daptomycin|Active Comparator
16114795|NCT02052388|Drug|Brilacidin|Experimental Drug
16114796|NCT02052375|Drug|ASP2408|subcutaneous injection
16114797|NCT02052375|Drug|Placebo|subcutaneous injection
16114798|NCT02052362|Drug|ABT-450/r/ABT-267|ABT-450, ABT-267 and ritonavir
16114799|NCT02052349|Drug|ABT-333|Dose of ABT-333
16114800|NCT02052336|Drug|CJ-12420 200mg + Clarithromycin 500mg|To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.
16114801|NCT02052336|Drug|CJ-12420 200mg|To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.
16114802|NCT02052336|Drug|Clarithromycin 500mg|To assess the effect of the coadministration of multiple dose of CJ-12420 and clarithromycin on the pharmacokinetics (PK) of CJ-12420 or clarithromycin.
16114803|NCT02052323|Drug|Artesunate/mefloquine (AS/MQ)|"artesunate (AS) 4mg/kg by mouth once daily at 0, 24 and 48 hours
~mefloquine (MQ) 15mg/kg by mouth once at 72 hours, and 10mg/kg once by mouth at 84-96 hours
~primaquine (PQ) 0.5mg/kg single dose by mouth at 84-96 hours"
16114804|NCT02052310|Drug|Roxadustat|Roxadustat will be administered per dose and schedule specified in the arm.
16114805|NCT02052310|Drug|Epoetin Alfa|Epoetin alfa will be administered TIW according to the epoetin alfa USPI or SmPC, or local SOC.
16114806|NCT02052297|Other|GSK2634673F|GSK2634673F is a synthetic peptide derived from the foot and mouth disease virus (FMDV2). GSK2634673F will be injected into a cubital or forearm vein intravenously and emission data acquired for up to 240 minutes. This radioactive ligand binds potently and specifically to the integrin alpha(V)beta6.
16114807|NCT02052284|Other|Sterile water application|Nurses are trained in proper dispensing and application of water in a sterile gentle way that will minimize shear force on the skin, risk for skin injury, and the potential for spread of fecal flora.
16114808|NCT02052271|Device|Cathodal cerebellar transcranial direct current stimulation|Active stimulation: duration: 20 mn, intensity: 2 mA; localisation : cerebellum; Placebo stimulation: duration: 9 seconds, intensity: 2 mA; localisation cerebellum;
16114809|NCT02052258|Drug|Oxytocin|
16114810|NCT02052232|Other|Experimental protein powder sachet|mixed with 8 oz. water
16114811|NCT02052232|Other|Control protein powder sachet|mixed with 8 oz. water
16114812|NCT02052219|Drug|Blisibimod|Blisibimod administered subcutaneously
16114813|NCT02052219|Drug|Placebo|Placebo administered subcutaneously
16114814|NCT02052206|Procedure|Shoulder replacement surgery|
16114815|NCT02052193|Drug|Dabrafenib|Measurement of toxicity related to UV exposure
16114816|NCT02052193|Drug|Vemurafenib|Measurement of toxicity related to UV exposure
16114817|NCT02052180|Drug|Exparel|EXPAREL arm: one vial (266 mg/20 mL) of EXPAREL (Bupivicaine Extended-Release Liposome, 13.3mg/ml), undiluted, will be administered for each of the specified procedures.
16114818|NCT02052180|Drug|Marcaine (Control)|15 cc of Marcaine 0.5% (Bupivacaine 0.5%, 5mg/ml) will be administered into the wrist per the Surgeon's Standard practice.
16114819|NCT02052167|Device|methotrexate prefilled pen|
16114820|NCT02052154|Biological|Prime-boost pneumococcal immunization|2 months between the 2 vaccines
16114821|NCT02052141|Biological|CINRYZE 500|500 Units of CINRYZE administered by IV injection
16114822|NCT02052141|Biological|CINRYZE 1000|1000 Units of CINRYZE administered by IV injection
16114823|NCT02052128|Drug|onapristone|
16114826|NCT02052089|Procedure|physiotherapy|Physiotherapy is the treatment of a wide range of conditions and injuries to the body through the use of various forms of passive mobilisation, massage, electrotherapy and exercises.
16114827|NCT02052089|Procedure|extracorporeal shockwave therapy|Extracorporeal shockwave therapy (ESWT) is noninvasive procedure, and has been shown to be effective in the treatment of chronic tendon pathology in the elbow, shoulder and plantar fascia. Shock wave therapy is traditionally categorized as either low energy (<0.2 mJ/mm2) or high energy (>0.2 mJ/mm2). Rompe, et al have hypothesized that there is an overstimulation of nerve fibers, resulting in an immediate analgesic effect (hyperstimulation analgesia). Physical effects on cell permeability and induction of diffusible radicals have also been postulated to cause disruption of the tendon tissue, resulting in induction of a healing process.
16114828|NCT02052089|Procedure|prolotherapy|Prolotherapy has been defined as the iatrogenic stimulation of wound healing and tissue repair through the injection of an irritant solution into damaged ligaments and tendons. Prolotherapy solutions are purported to initiate an inflammatory cascade at the site of injection, which induces fibroblast proliferation and subsequent collagen synthesis, resulting in a tighter and stronger ligament or tendon. The primary mechanism of action of prolotherapy is to induce a small inflammatory response to promote adequate healing or more viable scar tissue formation that results in stronger fibrous tissue at the lateral epicondyle, which leads to improved function and reduced pain.
16114829|NCT02052089|Procedure|platelet-rich plasma|Platelet-rich plasma (PRP) is defined as an autologous concentration of human platelets in a small volume of plasma which is mechanically treated to increase the concentration of platelets compared to whole blood. The supraphysiological concentration of platelets will provide a locally increased concentration of growth factors and cytokines that are contained within the platelets themselves.Based on these concepts, it is believed that PRP can augment or stimulate healing with the same biologic healing process that normally occurs in the human body after injury.
16114830|NCT02052076|Behavioral|Meal pattern|
16114831|NCT02052063|Device|stapled transanal rectal resection|transanal rectal resection using staple will be done for rectocele
16114832|NCT02052063|Device|Anal compliance measure with Endoflip system|Anal compliance will be measured using Endoflip system
16114833|NCT02052050|Other|core stability|
16114834|NCT02052037|Dietary Supplement|Egg inclusion|Participants will meet with a registered dietitian and receive instructions for including 2 eggs per day (10 to 14 eggs/week)in their meal plan, while preserving an isocaloric condition relative to the egg exclusion phase. The study dietitian will provide individualized guidance to participants on how to make room for eggs in their diet, while giving them latitude in determining how to adjust for the extra calories from the eggs, to better approximate real-world conditions. Treatment phase will last for 12 weeks.
16114835|NCT02052037|Dietary Supplement|Egg exclusion|"Participants will meet with the dietitian and receive relevant meal planning guidance and instructions to avoid eggs and specific egg-containing products.
~During both intervention phases, study participants will be advised to eat to their usual state of fullness, and dietary monitoring and weighing will be conducted to ensure that an isocaloric condition is maintained. Treatment phase will last for 12 weeks."
16114836|NCT02052024|Drug|Botox|Treatment group will receive 100 units of BOTOX and subjects will receive 1-3 injections per muscle at each visit.
16114837|NCT02052024|Drug|MYOBLOC|Treatment group will receive 5,000 units of MYOBLOC and subjects will receive 1-3 injections per muscle at each visit.
16114838|NCT02052011|Drug|Ranolazine|Subjects will take the extended-release Ranolazine for a total of 4 weeks. Subjects will take 500 mg twice daily for the first week and then 1000 mg twice daily for remaining period (Dosing will be adjusted with concomitant use of diltiazem, verapamil, erythromycin, simvastatin or metformin).
16114839|NCT02052011|Drug|Placebo|
16114840|NCT02051985|Other|Aerobic exercise training|"Days 1-2: active assisted mobilization (2 sessions/day, each 30 minutes duration).
~Days 3-4: as days 1-2 + unloaded bedside cycle ergometer (3 sessions/day, each 5-6 minutes duration).
~Days 5-6: as days 1-2 + bedside cycle ergometer at 10 W (3 sessions/day, each 15-20 minutes duration).
~Days 7-12: as days 1-2 + bedside cycle ergometer at 10-20 W (3 sessions/day, each 15-20 minutes duration).
~In addition, when possible according to their clinical conditions, patients will undergo one assisted ambulation session of 15-20 minutes per day."
16114841|NCT02051985|Other|Standard physical therapy|"Days 1-2: active assisted mobilization (2 sessions/day, each 30 minutes duration).
~Days 3-12: active assisted mobilization (1 session/day, 30 minutes duration).
~In addition, when possible according to their clinical conditions, patients will undergo one assisted ambulation session of 15-20 minutes per day."
16114842|NCT02051972|Device|Implanted with a Nanostim leadless pacemaker system|
16114843|NCT02051959|Device|Anodal stimulation of M1 + sham|8 active treatmments: 2mA anodal stimulation of M1 for 20 minutes (over the relevant cortex area) followed by 8 sham treatments.
16114844|NCT02051959|Device|Sham + Anodal stimulation of M1|8 sham treatments followed by 8 active treatmments: 2mA anodal stimulation of M1 for 20 minutes (over the relevant cortex area).
16114845|NCT02051959|Device|Cathodal stimulation of M1 + sham|8 active treatmments: 2mA cathodal stimulation of M1 for 20 minutes (over the relevant cortex area) , followed by 8 sham treatments.
16114846|NCT02051959|Device|Sham + Cathodal stimulation of M1|8 sham treatments followed by 8 active treatmments: 2mA cathodal stimulation of M1 for 20 minutes (over the relevant cortex area).
16114847|NCT02051946|Device|Retroject Device|
16114848|NCT02051946|Drug|ethacrynic acid injection|
16114849|NCT02051946|Drug|balanced salt solution|
16114850|NCT02051933|Drug|Botox|"At the time of definitive fixation, the hospital's investigational pharmacy will provide four syringes containing 0.5mL Botulinum toxin type A. The dose of botulinum toxin will be calculated based on the patient's weight in kilograms, such that a total dose of 200U of Botox will be used for a 70kg individual. The dosage will scale linearly in proportion to the patient's body weight, such that each kilogram change results in a 3U change in Botox (rounded to the nearest 30U interval change from 200U, with a maximum of 300U).
~45-55 kg: 140U 55-65 kg: 170U 65-75 kg: 200U 75-85 kg: 230U 85-95 kg: 260U 95-105 kg: 290U 105-115 kg: 300U"
16114893|NCT02051608|Drug|Gantenerumab|Gantenerumab will be administered as SC injection Q4W
16114894|NCT02051608|Drug|Placebo|Placebo will be administered as SC injection Q4W
16114941|NCT02051335|Drug|Scopolamine|Scopolamine subcutaneous injection
16114942|NCT02051322|Device|Jet Nebulizer|
16114943|NCT02051322|Device|Trunk Mask Nebulizer|
16114851|NCT02051933|Drug|Placebo|"At the time of definitive fixation, the hospital's investigational pharmacy will provide four syringes containing 0.5mL 0.9% sodium chloride solution . The dose of 0.9% sodium chloride will be calculated based on the patient's weight in kilograms, such that a total dose of 200U of Placebo will be used for a 70kg individual. The dosage will scale linearly in proportion to the patient's body weight, such that each kilogram change results in a 3U change in placebo(rounded to the nearest 30U interval change from 200U, with a maximum of 300U).
~45-55 kg: 140U 55-65 kg: 170U 65-75 kg: 200U 75-85 kg: 230U 85-95 kg: 260U 95-105 kg: 290U 105-115 kg: 300U"
16114852|NCT02051907|Device|KAM1403 Gel|
16114853|NCT02051907|Device|aloevera gel|
16114854|NCT02051894|Drug|Dobutamine|"Infants will receive treatment according to the preference of the responsible physician. As is common practice, dobutamine, dopamine and/or other treatments (including other cardiovascular drugs and/or volume replacement therapy with normal saline) will be administered.
~If dobutamine is used we will take a maximum of two blood samples from the baby for pharmacokinetic analysis."
16114855|NCT02051881|Other|Taking intestinal biopsies|
16114856|NCT02051868|Drug|Cisplatin|Cisplatin 60 mg/m2 as a 1 hour i.v. infusion once every 3 weeks.
16114857|NCT02051868|Drug|5-Fluorouracil (5-FU)|5-FU 1000 mg/m2/24h as a 96-hour continuous infusion over days 1 to 4 every 3 weeks.
16114858|NCT02051868|Drug|Carboplatin|Carboplatin 1-hour i.v. infusion to an area under the curve (AUC) of 5 once every 4 weeks.
16114859|NCT02051868|Drug|Paclitaxel|Paclitaxel 80 mg/m2 as a 1-hour i.v. infusion on day 1,8 and 15 of each (4-weekly) cycle.
16114860|NCT02051842|Drug|Metadoxine|
16114861|NCT02051829|Other|Comparison of the four screening score|Comparison of the four screening score, for patient making a preoperative assessment for SLBO (clinique Saint-Luc de BOuge)
16114862|NCT02051816|Device|Video Laryngoscopy|
16114863|NCT02051816|Device|Apneic Oxygenation|
16114864|NCT02051816|Device|Direct Laryngoscopy|
16114865|NCT02051816|Device|No Apneic Oxygenation|
16114866|NCT02051803|Behavioral|Distress Tolerance Treatment for Weight Concern (DT-W)|
16114867|NCT02051803|Behavioral|Health Education (HE)|
16114868|NCT02051790|Drug|florbetapir F 18|No study drug will be administered in this study - scans previously acquired in the course of clinical practice.
16114869|NCT02051777|Dietary Supplement|Oral Nutritional Supplement 1|Containing macro and micronutrients
16114870|NCT02051777|Dietary Supplement|Oral Nutritional Supplement 2|Containing macro and micronutrients
16114871|NCT02051777|Dietary Supplement|Dietary Advice|
16114872|NCT02051764|Drug|Flortaucipir F18|370 megabecquerel (MBq) IV single-dose
16114873|NCT02051764|Drug|Florbetapir F 18|370 megabecquerel (MBq) IV single-dose
16114874|NCT02051764|Procedure|Brain PET Scan|positron emission tomography (PET) scan of the brain
16114875|NCT02051751|Drug|BYL719|BYL719 will be administered orally once daily on a continuous dosing schedule and dosed on a flat-fixed dose and not adjusted by body weight or body surface area, starting on Day 2 in the dose escalation part and Day 1 in the dose expansion part. In the dose escalation part, the BYL719 starting dose will be 300mg, with anticipated dose escalation to 350mg. In the dose expansion part, BYL719 will be administered at the recommended dose determined in the dose escalation part.
16114876|NCT02051751|Drug|Paclitaxel|Paclitaxel will be administered once weekly at a dose of 80 mg/m2 i.v. (days 1, 8, 15 and 22) in a 28 day cycle in both dose escalation and expansion.
16114877|NCT02051738|Drug|Mebendazole - fasted state (Treatment A)|Participants will receive a single 500 mg dose of mebendazole fast-disintegrating chewable tablet in the fasted condition.
16114878|NCT02051738|Drug|Mebendazole - fed state (Treatment B)|Participants will receive a single 500 mg dose of mebendazole fast-disintegrating chewable tablet in the fed condition.
16114879|NCT02051725|Other|Active life-style intervention|
16114880|NCT02051712|Behavioral|exercise training|individualized exercise training
16114881|NCT02051712|Behavioral|Adherence measures|Measures to increase adherence to exercise training
16114882|NCT02051699|Procedure|radiographic of standing knee|the patients stand on their one leg with pillar support and both-leg then shoot the x-ray beam to their knee
16114883|NCT02051686|Drug|Tranexamic Acid|10 mg/kg TXA loading dose approximately 15 minutes before surgical start time and then 1 mg/kg/h TXA infusion over 10 hours.
16114884|NCT02051686|Drug|Placebo|The control group will receive a similar volume load of normal saline and maintenance doses.
16114885|NCT02051673|Biological|Biological/Vaccine: Enriched Hematopoetic Stem Cell Infusion|Enriched Hematopoetic Stem Cell Infusion
16114886|NCT02051660|Behavioral|Manualized CALM intervention|Managing Cancer and Living Meaning Cancer (CALM) is a short-term individual psychotherapy for patients with advanced disease.
16114887|NCT02051660|Behavioral|Non-manualized supportive intervention.|Supportive psycho-oncological intervention.
16114888|NCT02051634|Drug|Fermented Papaya Preparation (FPP)|A total of 9 grams of FPP per day (divided into three 3 gram doses) will be consumed for 8 weeks. Participants will consume three 3g sachets containing FPP per day - once 30-40 min before breakfast, once 30-40 min before lunch, and once 30-40 min before dinner. Participants will open the sachet, slowly empty contents into their mouth, and let it dissolve before swallowing.
16114889|NCT02051634|Drug|Sugar Pill|A total of 9 grams of placebo (sugar) per day (divided into three 3 gram doses) will be consumed for 8 weeks. Participants will consume three 3g sachets containing placebo per day - once with breakfast, once with lunch, and once with dinner. Participants will open the sachet, empty contents into their mouth, and let it dissolve before swallowing.
16114890|NCT02051621|Drug|Antiarrhythmic drug|medical treatment of atrial flutter with either flecainide (Tambocor ®) 100 mg twice daily, propafenone (Rytmonorm ®) up to 150 mg 3 times daily) or amiodarone (Cordarex®) 200 mg daily electrical cardioversion as needed
16114891|NCT02051621|Procedure|Cavo-tricuspid-isthmus-ablation|irrigated radiofrequency (RF)-ablation of the cavo-tricuspid-isthmus catheter used: Thermocool R (F-type), Biosense Webster, Diamond Bar, CA, USA
16114892|NCT02051621|Procedure|Pulmonary vein isolation|pulmonary vein angiography followed by antral pulmonary vein isolation using 3D-electroanatomical Mapping mapping system: Carto 3 (Biosense Webster, Diamond Bar, CA, USA) catheter used for irrigated RF-ablation: Navistar Thermocool R (D, E or F-type according to atrial dimensions), Biosense Webster, Diamond Bar, CA, USA
16114937|NCT02051335|Drug|Roflumilast|Roflumilast tablets
16114895|NCT02051595|Other|Vancomycin concentrations|Up to ten blood samples testing for vancomycin concentrations will be collected in subjects administered vancomycin as prophylaxis before cardiac surgery with cardiopulmonary bypass and modified ultrafiltration.
16114896|NCT02051582|Procedure|Surgeons using fluoroscopy with laser pointer|"Surgeons will attempt to obtain a perfect anterior-posterior (AP) and axillary views of a cadaver wrist using a mini-fluoroscopy unit equipped with a laser pointer.
~A perfect view is considered the ability to obtain perfect circle views through a cannulated mini acutrak screw that will have been placed into the cadaver prior to data collection.
~Surgeons will also be asked to wear three dosimeter badges: one on the collar, one on the waist, and a ring badge under a pair of regular sterile surgical gloves."
16114897|NCT02051582|Procedure|Surgeons using fluoroscopy without laser pointer|"Surgeons will attempt to obtain a perfect anterior-posterior (AP) and axillary views of a cadaver wrist using a mini-fluoroscopy unit equipped without a laser pointer.
~A perfect view is considered the ability to obtain perfect circle views through a cannulated mini acutrak screw that will have been placed into the cadaver prior to data collection.
~Surgeons will also be asked to wear three dosimeter badges: one on the collar, one on the waist, and a ring badge under a pair of regular sterile surgical gloves."
16114898|NCT02051569|Dietary Supplement|Tryptophan|Tryptophan and placebo are given in a crossover design, based on randomisation.
16114899|NCT02051556|Behavioral|Physical Therapy WSI|Each session has duration of one hour and includes a first part of warming up, a final part of cooling down (these two parts were the same for all the groups) and an active part that includes exercises with a number of repetitions according to the aim of potentiating the most affected side (WSI).
16114900|NCT02051556|Behavioral|Physical Therapy BSI|Each session has duration of one hour and includes a first part of warming up, a final part of cooling down (these two parts were the same for all the groups) and an active part that includes exercises with a number of repetitions according to the aim of potentiating the least affected side (BSI).
16114901|NCT02051556|Behavioral|Physical Therapy ST|Each session has duration of one hour and includes a first part of warming up, a final part of cooling down and an active part that includes exercises with a number of repetitions according to the aim of potentiating both sides equally (ST). In this case the number of repetitions was the same for both sides.
16114902|NCT02051543|Behavioral|Brief Behavioral Treatment of Insomnia -Military Version|
16114903|NCT02051530|Dietary Supplement|tryptophan depletion|tryptophan depletion involves the ingestion of an amino acid mixture that is devoid of tryptophan. on the other day participants receive placebo, being the same mixture but including tryptophan
16114904|NCT02051504|Behavioral|Incremental maximal exercise|The exercise test starts 2-4h after a standardised breakfast. After a 2-min resting period sitting on the cycle ergometer (Excalibur Sport, Lode B.V, Medical Technology, Groningen, Netherlands), the test starts at 30 watts with a 20 watts increment every 2min until exhaustion.
16114905|NCT02051504|Dietary Supplement|Oral Glucose Tolerance Test|The subjects arrive after an overnight fast and have a 75g Glucose Oral Charge.
16114906|NCT02051504|Procedure|Muscle biopsy|A sample of vastus lateralis (less than 150mg) is taken with a specific needle under local anesthesia.
16114907|NCT02051504|Procedure|Combined DLCO-DLNO|Lung carbon monoxide and nitric oxide diffusion capacities are assessed at rest in a sitting position.
16114908|NCT02051504|Procedure|Dual energy X-ray absorptiometry|Body composition is measured using dual energy X-ray absorptiometry at rest.
16114909|NCT02051504|Procedure|Accelerometry over one week|The subjects wear an uniaxial accelerometer over one week to assess their usual physical activity level
16114910|NCT02051504|Other|Questionnaires|Diet questionnaire, quality-of-life questionnaires, physical activity questionnaires
16114911|NCT02051491|Device|BP-NCPAP|Initial settings of BP-NCPAP will be a lower level PEEP of 5 cm H2O and a higher level PEEP of 8 cm H2O at a cycle rate of 20 per minute with 1 second at the higher PEEP per cycle. The settings can then be adjusted and titrated up to a maximum of 7 and 10 cm H2O for the lower and higher PEEPs respectively at a maximum rate of 30 cycles per second based on FiO2 requirements.
16114912|NCT02051491|Device|NIHFV|The initial settings will be a MAP of 8 cm H2O, frequency of 10 Hz, and amplitude of 20 cm H2O. The maximum allowable MAP will be 10 cm of H2O. The range of frequency allowed will be 6 - 14 Hz. Both frequency and amplitude will be adjusted to try and achieve palpable/visible chest movement and to achieve target CO2 levels for the particular patient.
16114913|NCT02051478|Other|Thoracic mobilization|Patients will receive 20 seconds bouts of grade III-IV of central posterior-anterior (PA) non-thrust mobilization from T3 to T6 spinous process as described by Maitland et al for an overall intervention time of approximately 2 minutes
16114914|NCT02051478|Other|Thoracic manipulation|A high-velocity, end range, anterior-posterior thrust applied through the elbows to the mid-thoracic spine will be applied
16114915|NCT02051465|Device|LumenR Retractor|Polyp removal using LumenR Retractor Modified overtube
16114916|NCT02051465|Device|Removal without overtube|Endoscopic removal of polyp without overtube
16114917|NCT02051452|Drug|Methylphenidate|
16114918|NCT02051452|Other|Saline|
16114919|NCT02051439|Procedure|Valsava|The patients were randomized to 2 groups. The first group performed conventional Valsava 3 times before balloon assisted Valsava 3 times. The second group performed balloon assisted Valsava 3 times before conventional Valsava 3 times for venous reflux examination by duplex scan.
16114920|NCT02051426|Other|D-serine|single P.O. administration of D-serine (2.1g)
16114921|NCT02051426|Other|Placebo|single P.O. administration of Placebo
16114922|NCT02051413|Drug|Venlafaxine extended release|antidepressant drug
16114923|NCT02051400|Device|the McGrath® MAC video laryngoscope|
16114924|NCT02051400|Device|the GlidesScope® Ranger video laryngoscope|
16114925|NCT02051400|Device|the Macintosh laryngoscope|
16114926|NCT02051387|Drug|Cannabidiol CR|
16114927|NCT02051387|Drug|Cannabidiol|
16114928|NCT02051387|Drug|Amisulpride|
16114929|NCT02051387|Drug|Olanzapine|
16114930|NCT02051387|Drug|Quetiapine|
16114931|NCT02051387|Drug|Risperidone|
16114932|NCT02051387|Drug|Placebo|
16114933|NCT02051374|Procedure|Decompression alone|
16114934|NCT02051374|Procedure|Decompression followed by fusion with instrumentation|
16114935|NCT02051348|Biological|Pylopass|Pylopass
16114936|NCT02051348|Biological|Placebo|Placebo
16114945|NCT02051309|Drug|Guanfacine|6mg/day ER with 3-week lead-in period. Maintained at steady state throughout 8 week treatment phase. After treatment phase, given taper supply of medication. Follow up at 1 month, 2 months and 6 months.
16114946|NCT02051309|Drug|Placebo|
16114947|NCT02051296|Drug|Minocycline|RCT blinded placebo trial
16114948|NCT02051296|Drug|placebo|RCT blinded placebo trial
16114949|NCT02051283|Other|RFA|RFA
16114950|NCT02051270|Other|Descriptive study|More than 65 years old elders
16114951|NCT02051257|Biological|Autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T cells|Given IV
16114952|NCT02051257|Biological|Autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tn/mem-enriched T-lymphocytes|Given IV
16114953|NCT02051257|Other|Laboratory Biomarker Analysis|Correlative studies
16114954|NCT02051231|Drug|Oxytocin|Oxytocin, 10-10mol/L to 10-5mol/L
16114957|NCT02051192|Behavioral|Parent-Led Exposure Therapy|Therapists will work with families for 10 sessions, twice weekly. The first treatment session will be a 90 minute parent only psychoeducation and treatment preparation session. Each subsequent session will last up to 60 minutes and will consist of exposure therapy using developmentally appropriate modulated behavioral approaches such as Participant modeling (PM) and Reinforced practice (RP).
16114958|NCT02051192|Other|Treatment As Usual|Patients randomized to the TAU arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice. These participants may also elect to receive no treatment at all during the TAU period.
16114959|NCT02051153|Drug|Modafinil|Modafinil (2-[(Diphenylmethyl) sulfinyl]acetamide (Provigil, 1997)) is a novel drug which has a demonstrable efficacy in the treatment of daytime sleepiness associated with narcolepsy (Benerjee et al., 2004). Studies on healthy volunteers show that modafinil improves neuropsychological task performance in some healthy individuals (Turner et al., 2004; Baranski et al., 2004; MÜller et al., 2004; Randall et al., 2005) and in patients with neuropsychiatric disorders (Minzenberg & Carter, 2008).
16114960|NCT02051153|Drug|Placebo|
16114961|NCT02051140|Dietary Supplement|Freeze-dried Strawberry|12g freeze-dried strawberry (powder), twice daily with water, for 90 days
16114962|NCT02051140|Dietary Supplement|Strawberry Placebo|12g blue, strawberry-flavored powder, twice daily with water, for 90 days
16114963|NCT02051127|Other|Exercise|Physical training Duration: 45-60 minutes Frequency: 3 times per week Intensity: mean heart rate > 75% of maximum heart rate determined by exercise test before start of the intervention
16114964|NCT02051101|Other|Biopsy sample from Port Wine Stain Birthmark|Biopsy sample from Port Wine Stain Birthmark
16114965|NCT02051088|Procedure|Revascularization with drug-eluting technology|Endovascular intervention with the use of drug-eluting devices (drug-coated balloons and/or drug-eluting stents).
16114966|NCT02051088|Procedure|Revascularization without drug-eluting technology|Endovascular intervention without using drug-eluting balloons or stents
16114967|NCT02051088|Device|drug-coated balloons and/or drug-eluting stents|
16114968|NCT02051075|Biological|PXN sperm treatment|immotile sperm activation with PXN
16114969|NCT02051075|Biological|Sperm activation with PXN and oocyte activation|
16114970|NCT02051062|Biological|One 5 mL of blood will be collected.|The blood sample should be collected no later than 24 hours post BAT® administration. To ensure sufficient detectable circulating levels of BAT® for pharmacokinetic analysis the target window of time for collection should be between 6 and 24 hours post-BAT® administration.
16114971|NCT02051036|Procedure|Moxibustion|"In the moxibustion treatment group, 5 moxibustion points (bilateral SP6, LV3 and unilateral CV4) will be heated with indirect moxibustion (KangHwa, Korea).
~The moxa pillars will be removed when the patient feel hotness and require to remove them.
~The moxibustion will be conducted repeatedly unless patients feel the sense of heat up to seven times per session."
16114972|NCT02051023|Drug|FML 0.1% eyedrops|Ocular topical application of fluorometholone 0.1% 4 times a day during 22 days
16114973|NCT02051023|Drug|Liquifilm artificial tears eyedrops|Liquifilm instillation 4 times a day for 22 days
16114974|NCT02050971|Biological|Umbilical Cord Blood Infusion|Cord blood collection after delivery of the baby. Preservation of blood in blood bank. Transfusion of autologous cord blood within the first 5 postnatal days.
16114975|NCT02050971|Biological|Intravenous Infusion of Peripheral Blood or its Components|Regular treatment of neonatal anemia with peripheral blood or its components transfusion.
16114976|NCT02050958|Drug|OXP001|
16114977|NCT02050958|Drug|Ibuprofen|
16114978|NCT02050945|Behavioral|Resistance training|
16114979|NCT02050945|Behavioral|Endurance training|
16114980|NCT02050932|Dietary Supplement|60 mg Fe as FeSO4 with stable isotopic labels|Subjects will receive FeSo4 supplements labeled with stable isotopic labels (54Fe, 57Fe, 58Fe) and iron absorption will be measured for each administration
16114981|NCT02050919|Drug|Epirubicin Hydrochloride|Given IV
16114982|NCT02050919|Radiation|External Beam Radiation Therapy|Undergo EBRT
16114983|NCT02050919|Drug|Ifosfamide|Given IV
16114984|NCT02050919|Other|Laboratory Biomarker Analysis|Correlative studies
16114985|NCT02050919|Drug|Sorafenib Tosylate|Given PO
16114986|NCT02050919|Procedure|Therapeutic Conventional Surgery|Undergo surgical resection
16114987|NCT02050906|Behavioral|behavioral dietary intervention|Patients undergo nutritional counseling over 30 minutes once weekly during months 1-2 and then every 2 weeks via telephone calls during month 3.
16114988|NCT02050906|Behavioral|exercise intervention|Patients undergo 1 hour of intensive exercise comprising 30 minutes of aerobic exercise and 30 minutes of resistance exercise twice weekly during weeks 1-6, once weekly during weeks 7-8, and independently during weeks 7-12.
16114989|NCT02050906|Other|behavioral activity counseling|Undergo behavioral activity and nutritional counseling
16114990|NCT02050906|Behavioral|telephone based counseling|Undergo behavioral activity and nutritional counseling
16114993|NCT02050893|Drug|sedatives(Midazolam and Propofol)|
16114994|NCT02050841|Biological|octaplas|Octaplas S/D Plasma
16114995|NCT02050828|Drug|AKB-9778|
16114996|NCT02050828|Drug|ranibizumab|
16114997|NCT02050828|Drug|Placebo|
16114998|NCT02050828|Drug|Sham|
16114999|NCT02050815|Drug|MEK162|
16115000|NCT02050802|Drug|Moxifloxacin 400 mg|
16115001|NCT02050802|Drug|Macitentan 10 mg|
16115002|NCT02050802|Drug|Macitentan 30 mg|
16115003|NCT02050802|Other|Placebo|
16115004|NCT02050789|Behavioral|flexible duty hours|If a hospital is assigned to the intervention arm, all categorical and preliminary general surgery residents in that general surgery program will switch to the flexible duty hours while at an enrolled hospital.
16115005|NCT02050776|Biological|Autologous bone marrow mononuclear cell transplantation|bone marrow derived mononuclear cells are administered intrathecally and intramuscularly in limb girdle muscular dystrophy patients
16115006|NCT02050763|Behavioral|The SHARE Project|"SHARE aimed to reduce IPV and used methodologies from two proven successful violence prevention frameworks: Stepping Stones (Welbourn, 1995) and the Resource Guide for Mobilizing Communities to Prevent Domestic Violence (Michau & Naker, 2003). SHARE promoted a process of social change based on the Transtheoretical Model's Stages of Change Theory (Prochaska & DiClemente, 1983; Prochaska & Velicer, 1997) which posits that although people realize they need to make changes in their life, they do it in stages instead of one major life change. There are five main stages of change: (1) pre-contemplation, (2) contemplation, (3) preparation for action, (4) action and (5) maintenance.
~We hypothesized that repeated exposure to the ideas included in SHARE would encourage men and women to begin a process of change that results in preventive behavior."
16115007|NCT02050724|Drug|Radioactive labelling of pulmonary nodules|Application directly into a pulmonary nodule
16115008|NCT02050724|Device|CT guided radioactive labelling|CT guided puncture is a standard procedure in radiology. In this study it is used to mark pulmonary nodules for the following thoracoscopic surgery, done with a handheld-SPECT device.
16115009|NCT02050724|Device|Electromagnetic guided bronchoscopic radioactive labelling|Electromagnetic guided bronchoscopy is a standard procedure. In this study it is used to mark pulmonary nodules.
16115010|NCT02050711|Behavioral|Pulmonary rehabilitation|
16115011|NCT02050711|Other|Usual care|
16115012|NCT02050698|Procedure|Protected weightbearing in a hard-soled shoe|Patients allocated to experiment group are allowed tolerable weightbearing in a hard-soled shoe after one week of immobilization in a posterior splint
16115013|NCT02050698|Procedure|Protected weightbearing in a short leg walking cast|Patients allocated to control group are allowed tolerable weightbearing in a short leg walking cast after one week of immobilization in a posterior splint
16115014|NCT02050685|Other|All patients incoming in the sleep study centre for a PSG|All patients incoming in the sleep study centre for a PSG. Comparison between screening score and AHI derived from PSG.
16115015|NCT02050672|Dietary Supplement|Myo-inositol|
16115016|NCT02050672|Other|untreated|
16115017|NCT02050646|Other|Low Salt Diet|On Day 0, patients will be randomized to one of the two crossover liberal/low or low/liberal salt diet groups. Each subject will complete two controlled dietary phases: 10-days of low salt diet, a washout period of 3-days, and 10-days of liberal salt diet.
16115018|NCT02050646|Other|Liberal salt diet|On Day 0, patients will be randomized to one of the two crossover liberal/low or low/liberal salt diet groups. Each subject will complete two controlled dietary phases: 10-days of low salt diet, a washout period of 3-days, and 10-days of liberal salt diet.
16115019|NCT02050607|Other|fecal microbiota transplantation from healthy lean donors|fecal microbiota transplantation from healthy lean donors
16115020|NCT02050594|Drug|Ipilimumab|
16115021|NCT02050555|Dietary Supplement|Placebo|
16115022|NCT02050555|Dietary Supplement|Koji-extracted beverage fermented with Pediococcus pentosaceus LP28|
16115023|NCT02050542|Procedure|systematic biopsies|90 patients will have to undergo 12 systematic transrectal ultrasound-guided biopsies of the prostate
16115024|NCT02050542|Procedure|Targeted biopsies guided by a fusion of MRI and ultrasound- images|Immediately after the 12 systematic biopsies, the same patients will have to undergo 3 additional targeted biopsies on the suspicious image detected by IRM, guided by a fusion of MRI and ultrasound- images with the Koelis ® system
16115025|NCT02050529|Drug|Labetalol|Group A( Labetalol) will be receive intravenous labetalol bolus doses as specified in protocol summary.
16115026|NCT02050529|Drug|Hydralazine|Group B(Hydralazine) will serve as control and will receive active comparator Hydralazine intravenous bolus doses as specified in summary.
16115027|NCT02050516|Other|micro-well group culture dish|an embryo culture dish containing nine micro-wells in the middle.
16115028|NCT02050477|Procedure|Laparoscopic Vertical Gastroplasty|The Magenstrasse and Mill procedure is a conservative vertical gastroplasty described in 1987 through a laparotomy. A tubular gastric pouch is created by a vertical stapling extending from the antrum to the angle of Hiss. In this study, we evaluate the laparoscopic technique of the procedure.
16115029|NCT02050451|Dietary Supplement|Ensure Plus®|
16115030|NCT02050451|Dietary Supplement|Multivitamin|
16115031|NCT02050438|Procedure|Total Knee Arthroplasty|
16115032|NCT02050425|Device|Placebo-CPAP device|short-term CPAP withdrawal by the use of Placebo-CPAP
16115033|NCT02050425|Device|CPAP|Patients continue therapeutic CPAP therapy
16115034|NCT02050412|Other|Cat fur scratch test|
16115035|NCT02050399|Other|Isometric exercise|The isometric protocol (handgrip) will be performed into 4 percentages of MVC (15, 30, 45 and 60%) to exhaustion in 3 postures (supine, seated and standing position). The percentages and the postures will be randomized. In the first day of exercise protocol the subjects will be at rest during 10 minutes and will perform 3 MVC during 5 seconds, with 5 minutes of recovery. The higher value of MVC will be used to prescribe the percentages. The subjects will perform two contractions until exhaustion in one posture in each day.
16115036|NCT02050386|Other|Cold pressor stimulation|Immersion of the foot in 0-2 degrees C water for 50 seconds
16115037|NCT02050386|Other|Sham Stimulation|Immersion of the foot in room temperature water for 50 seconds
16115038|NCT02050373|Radiation|Low-Level laser|Application of laser therapy in low power mucosa jugal right and left upper and lower labial mucosa, floor of the mouth, tongue side of the right and left and belly of the tongue.
16115042|NCT02050347|Genetic|CD19.CAR-CD28Z T Cells - dose escalation 2|"Patients will receive one of the following dose levels:
~Dose Level 1: 5 ×10^5 cells/kg
~Dose Level 2: 1×10^6 cells/kg
~Dose Level 3: 5×10^6 cells/kg"
16115043|NCT02050347|Genetic|CD19.CAR-CD28Z T Cells - dose escalation 1|"Patients will receive one of the following doses:
~Dose Level one: 1x10^5 cells/kg
~Dose Level 2: 5x10^5 cells/kg
~Dose Level 3: 1x10^6 cells/kg"
16115044|NCT02050334|Drug|CC100|CC100 reconstituted in diluent
16115045|NCT02050334|Drug|Placebo|Diluent. Amount to match CC100 dose.
16115046|NCT02050321|Drug|Acitretin|A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months
16115047|NCT02050321|Drug|Vemurafenib|A combination of Acitretin and Vemurafenib will be administered to determine if it reduces the incidence of biopsy-confirmed cSCC at 6 months
16115048|NCT02050308|Other|Internet-All Nations Breath of Life (I-ANBL)|"Participants will be asked to log into the website prior to the first session to allow for any problems with the site to be fixed prior to sessions starting. Topics we anticipate covering include, but are not limited to: preparing to quit, dealing with cravings, support systems, traditional tobacco, stress reduction, weight management, and staying quit, along with other topics determined during program development. For each session, the tribal college student will begin the session by answering a series of questions to produce an individually-tailored report that will be provided on the screen at the end of each week's session so that the smoker can work on strategies during the week before the next internet session
~Weekly procedures will follow the same format as for the first session"
16115049|NCT02050308|Other|Honoring the Gift of Heart Health|"These sessions help American Indians learn about what they can do to prevent heart disease. We will emphasize the increase consumption of fruits and vegetables as well as addressing other heart healthy activities. Honoring the Gift of Heart Health is a user-friendly program developed especially for American Indians. The manual provides the how-to for leading group education sessions. It offers hands-on activities that help people build the skills they need to make simple, practical, and lasting changes to help them fight heart disease. The protocol will follow procedures as the I-ANBL arm, however, this fruit and vegetable arm will not include individually tailored components, but just interactive web-based materials related to increasing heart health, including certain activities."
16115050|NCT02050308|Drug|Nicotine gum, Patch, or Lozenge or Zyban® or Chantix®|Regardless of the intervention arm to which subjects are assigned, they will choose the option of nicotine replacement therapy they want, as long as they are eligible for it. All participants are offered the medications, but they do not have to take any medication to participate in the study.
16115051|NCT02050295|Procedure|Nerve block washout|Saline will be infused through the perineural catheter to reverse motor block.
16115052|NCT02050295|Procedure|Sham washout|Infusion of saline to maintain catheter patency.
16115053|NCT02050295|Drug|Saline|
16115054|NCT02050282|Other|Supplementary NT-proBNP measurement|In patients randomized to the strategy with supplementary measurement of NT-proBNP, a blood sample will be drawn from the peripheral venous catheter that is routinely inserted and analyzed immediately using a COBAS H232 and Roche Diagnostics NT-proBNP assay.
16115055|NCT02050269|Drug|Iohexol|Iohexol, 300 mg/mL
16115056|NCT02050256|Other|continuing medical education and electronic decision support|
16115057|NCT02050256|Other|education and electronic support|Continuing medical education and electronic decision support to General Practitioners.
16115058|NCT02050243|Drug|5ALA|20mg/kg of oral suspension of 5ALA
16115059|NCT02050230|Biological|Blood transfusion|One unit of red blood cells will be transfused over the course of 20 minutes
16115060|NCT02050217|Procedure|Neurally Adjusted Ventilatory Assist|
16115061|NCT02050204|Behavioral|Intervention|The intervention was a 3-month structural and social change process designed to increase employee control over work time and family supportive supervisory behaviors (Kossek et al., in press). The change process was an integration of two previously evaluated interventions (Hammer et al., 2011; Kelly et al., 2011). A facilitator led 8 hrs of participatory sessions to transition employees from a time-based to a results-based work culture. Supervisors participated in all change activities plus 4hrs of training in supportive supervision. Training in family supportive supervision was implemented with behavioral computer-based training (cTRAIN, NWeta, Lake Oswego, OR) followed by 2 rounds of goal-setting and behavioral self-monitoring using an iPod Touch (Habitrack, OHSU, Portland, OR).
16115062|NCT02050191|Behavioral|www.princetonlivingwell.com|
16115063|NCT02050178|Drug|OMP-54F28, Nab-Paclitaxel and Gemcitabine|
16115064|NCT02050165|Dietary Supplement|KIND Bars|Consumption of KIND Bars for 12 weeks
16115065|NCT02050165|Dietary Supplement|Typical American Snack|Consumption of typical American snacks for 12 weeks
16115066|NCT02050152|Behavioral|Explicit and Implicit memory|Explicit and implicit memory will be tested visually (showing an animal) and auditory (telling a joke, stating a food type that starts with the letter B) and smell recall (bad smell of anesthesia)
16115067|NCT02050152|Drug|0% nitrous oxide, 30% nitrous oxide and 60% nitrous oxide|
16115068|NCT02050139|Dietary Supplement|L-cysteine|
16115069|NCT02050139|Other|Placebo|
16115070|NCT02050126|Device|Lumenis UltraPulse Encore.|Treatment using Lumenis UltraPulse Encore.
16115071|NCT02050113|Device|Custom Made Fenestrated or Branched Stent Graft|The surgeon will place a custom made graft, t-Branch device or modify commercially available stent grafts to match the anatomy of the patient being treated. Small fenestrations (holes) will be made in the stent graft so that additional stents can be inserted through the fenestration and into the blood vessels that lead to the kidneys, intestines or liver. These stents allow blood to flow freely to these organs. If the aneurysm is in the aortic arch stents may be placed in the carotid and subclavian arteries. This surgery is done through small incisions in the groin and sometimes in the upper arm.
16115072|NCT02050087|Device|Simple sling.|
16115073|NCT02050087|Device|Neutral brace|
16115074|NCT02050074|Drug|Colesevelam|
16115075|NCT02050074|Drug|Metformin|
16115076|NCT02050074|Other|Placebo|
16115077|NCT02050061|Other|compression stocking|study the impact of compression stocking
16115124|NCT02049606|Drug|CENATONE tablet|2 Tablets once a day
16115125|NCT02049593|Drug|PARP inhibitor BMN-673|Given PO
16115126|NCT02049593|Drug|temozolomide|Given PO
16115127|NCT02049593|Drug|irinotecan hydrochloride|Given IV
16115078|NCT02050048|Other|Administration of Lactated Ringer's (LR) Solution|"Patients will be randomized to low volume or high volume group. Patient in the low volume group will receive fluids via infusion at a rate of 1.5 cc/kg/hr. Fluid administration may be continued through the 90 minute post-procedure observation period. Patients in the high volume group will receive fluids via infusion by the following weight based regimen:
~initial bolus of LR prior to ERCP of 7.5 cc/kg over 1 hour
~LR fluid infusion during the procedure at 5 cc/kg/hr
~Post-procedure bolus of 20 cc/kg over 90 minutes"
16115079|NCT02050035|Other|Aerobic Exercise Training|Supervised outpatient moderate to vigorous aerobic training at 60% - 85% heart rate reserve, carried out for 45 minutes, three times per week over a twelve week period.
16115080|NCT02050009|Drug|metformin hydrochloride|Given PO
16115081|NCT02050009|Drug|carboplatin|Given IV
16115082|NCT02050009|Drug|paclitaxel|Given IV
16115083|NCT02050009|Other|laboratory biomarker analysis|Correlative studies
16115084|NCT02049983|Device|Use of Levita Magnetics Grasper|
16115085|NCT02049970|Drug|dexmedetomidine|1 ml 100 mcg dexmedetomidine+ 15 ml 0.25 % bupivacaine are applied around brachial plexus
16115086|NCT02049970|Drug|bupivacaine|30 ml 0.25 % bupivacaine is applied around brachial plexus
16115087|NCT02049957|Drug|Sapanisertib|Sapnisertib capsules
16115088|NCT02049957|Drug|Fulvestrant|Fulvestrant IM injection.
16115089|NCT02049957|Drug|Exemestane|Exemestane tablets.
16115090|NCT02049944|Drug|Cefazolin|Participants who are undergoing an elective cesarean section at term will receive 3 grams of Cefazolin at least 30, but no more than 60 minutes prior to skin incision administered through an intravenous line.
16115091|NCT02049931|Device|No brace treatment|Patients in the no brace group were allowed to ambulate without any braces as long as it would be tolerable.
16115092|NCT02049931|Device|Rigid brace|In rigid brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the rigid brace for a total of 8 weeks.
16115093|NCT02049931|Device|Soft brace|In soft brace group, brace is required to be worn at all times except when lying. All patients were instructed to wear the soft brace for a total of 8 weeks.
16115094|NCT02049905|Drug|Aldoxorubicin|
16115095|NCT02049905|Drug|Investigator's Choice Treatment (Darcabazine, Pazopanib, Gemcitabine + Docetaxel, Doxorubicin, Ifosfamide)|
16115096|NCT02049892|Other|Metal Ion Levels|
16115097|NCT02049879|Drug|Corticosteroids injection|A solution of triamcinolone 40 mg (Kenalog) mixed with 3 cc of 2% xylocaine without epinephrine.
16115098|NCT02049866|Drug|Denosumab|Denosumab 60mg, administered every 6 months by subcutaneous injection for 36 months
16115099|NCT02049853|Device|"NTproBNP measurement with point of care device Cobash232 in the POCT group"|
16115100|NCT02049840|Device|Altis Single Incision Sling System|Altis Single Incision Sling (SIS) System is a permanently implantable synthetic sling for the surgical treatment of Stress Urinary Incontinence
16115101|NCT02049827|Other|participation in the study|
16115102|NCT02049814|Drug|Metformin|Metformin tablets
16115103|NCT02049814|Drug|Voglibose|Voglibose tablets
16115104|NCT02049814|Drug|Acarbose|Acarbose tablets
16115105|NCT02049801|Drug|MEK inhibitor MEK162|Given PO
16115106|NCT02049801|Drug|idarubicin|Given IV
16115107|NCT02049801|Drug|cytarabine|Given IV
16115108|NCT02049801|Other|pharmacological study|Correlative studies
16115109|NCT02049801|Other|laboratory biomarker analysis|Correlative studies
16115110|NCT02049788|Behavioral|low calorie/fat diet|Conventional behavioural lifestyle modification instructions x 1/month for 6 months about low-calorie (approximately 1200-1300 kcal/day), low-fat (25% of total calories from fat) and about physical activity (increase non-weight bearing exercise 30 minutes/day at least x 3 times/week, increase physical activity in their routine and decrease sedentary activity).
16115111|NCT02049788|Behavioral|Low glycaemic index diet|Experimental behavioural lifestyle modification instructions x 1/month for 6 months about low glycaemic index diet (selection of low-GI carbohydrates with the caloric distribution of carbohydrate 50-55%: protein 15-20%: fat 30-35%, instruction by two-hour small classes with parental participation low GI cooking demonstration and food labeling guidance) and about physical activity (increase non-weight bearing exercise 30 minutes/day at least x 3/week, increase physical activity in their routine and decrease sedentary activity).
16115112|NCT02049775|Procedure|NBI|
16115113|NCT02049762|Drug|Aspirin|Aspirin 100 mg vs. placebo in ACS patients on P2Y12 inhibitors a month following PCI.
16115114|NCT02049749|Behavioral|Immediate CARE|CARE is a group parent training informed by the principles of Parent Child Interaction Therapy and was developed by Trauma Treatment Training Center and CHOP Policy Lab. CARE has been used in many populations including residential treatment center/domestic violence shelter staff, daycare providers, graduate students, biological parents, and foster parents/caseworkers. Goals are to decrease stress for caregivers, improve child behavior, and enhance the caregiver-child relationship, family stability, and wellness. The training teaches parents to follow a child's lead thus building a connection and promoting positive behaviors. The focus is on giving attention to child's pro-social behavior and ignoring minor misbehavior. The second phase teaches techniques for giving effective commands.
16115115|NCT02049736|Drug|Telbivudine|
16115116|NCT02049710|Behavioral|Seventeen Days|Interactive video includes highlighting salience of active choices in sexual decision making, modeling different responses to sexual situations, cognitive rehearsal of preventive behaviors, and information about hormonal and non-hormonal contraception
16115117|NCT02049710|Behavioral|Driving Skills for Life|Interactive video includes guidance and practice for safe driving techniques, driver and car care tips, an eco-driving learning module, and interactive driving games.
16115118|NCT02049697|Drug|14C-JNJ-39823277|Participants will receive a single oral dose of 25 mg 14C-JNJ-39823277 as a 50-mL solution.
16115119|NCT02049684|Procedure|Patch|
16115120|NCT02049671|Drug|Growth Hormone Therapy|
16115121|NCT02049632|Procedure|Omission of axillary clearance|
16115122|NCT02049619|Device|pharyngeal pack|Following endotracheal intubation, one saline soaked, gauze pharyngeal pack was inserted into the hypopharynx under direct vision using McGill's forceps. The packs were tied to the endotracheal tube and their placements were documented on the scrub nurse's count board.
16115123|NCT02049606|Drug|LAYLA tablet|1 Tablet twice a day
16115128|NCT02049593|Other|pharmacological study|Correlative studies
16115129|NCT02049593|Other|laboratory biomarker analysis|Correlative studies
16115130|NCT02049580|Drug|Thiotepa|Thiotepa (10 mg/kg /day) will be administered every 12 h, at day -6
16115131|NCT02049580|Drug|Fludarabine|"Fludarabine (30mg/m2/day x 4 days) will be dosed according to renal function. For decreased creatinine clearance (CCr) (≤ 61 mL/min) Fludarabine dosage should be reduced as follows:
~CCr 46-60 mL/min, fludarabine = 24 mg/ m2/day"
16115132|NCT02049580|Drug|Cyclophosphamide|"Pre-transplantation Cyclophosphamide(Cy) 30 mg/kg/day will be administered as a 1-2 hour intravenous infusion with a high volume fluid flush on Days -5.
~Cy will be dosed according to the recipient's ideal body weight (IBW), unless the patient weighs more than 125% of IBW, in which case the drug will be dosed according to the Adjusted IBW (AIBW)
~Cyclophosphamide [50 mg/kg/day IBW] will be given on Day 3 post-transplant (between 60 and 72 hours after marrow infusion) and on Day 4 post-transplant (approximately 24 hours after Day 3 cyclophosphamide). Cyclophosphamide will be given as an IV infusion over 1-2 hours (depending on volume)."
16115133|NCT02049567|Device|FluidVision AIOL|Investigational implantable medical device intended for long-term use over the lifetime of the cataract subject
16115134|NCT02049567|Procedure|Cataract Surgery|Performed using standard microsurgical techniques
16115135|NCT02049554|Other|Preconception Care Screener|
16115136|NCT02049541|Drug|PI3K inhibitor BKM120|Will be supplied to each patient on the first day of each cycle. It will subsequently be self administered by the patient themselves daily on days 1-28 of every 28 day cycle
16115137|NCT02049541|Biological|rituximab|Given IV (intervenously) on days 2, 8, 15, and 22 of cycle 1, and subsequently on day 1 of cycles 3, 5, 7, 9, and 11.
16115138|NCT02049541|Other|Pharmacodynamics|Pharmacodynamic samples from peripheral blood (for those with peripheral blood involvement) and bone marrow aspirate (for all patients) are drawn at baseline.
16115139|NCT02049541|Other|Correlative studies|Patients will undergo correlative studies to include bone marrow biopsy at study enrollment, and at the time of complete remission. In addition, patients with peripheral blood involvement at enrollment will have peripheral blood drawn for all planned research correlates.
16115140|NCT02049528|Drug|CC-122|CC-122
16115141|NCT02049528|Drug|CC-122|CC-122
16115142|NCT02049528|Drug|CC-122|CC-122
16115143|NCT02049515|Drug|IPI-145 (duvelisib)|PI3K Inhibitor
16115144|NCT02049515|Drug|Ofatumumab|
16115145|NCT02049502|Biological|biologically active human fecal microbiota|instillation of biologically active human fecal microbiota material via flexible sigmoidoscopy
16115146|NCT02049502|Procedure|sigmoidoscopy|
16115147|NCT02049489|Biological|ICT-121 DC vaccine|autologous dendritic cells pulsed with peptide antigens
16115148|NCT02049476|Drug|Dexamethasone pellet|"Dexamethasone pellet placement occurs within 14 days of baseline examination; for patients with bilaterally active uveitis, placement of a dexamethasone pellet in the second eye should occur within 14 days of the first implantation or within 30 day of the baseline examination.
~Repeated placement is permitted every 3 months based on the best clinical judgment of the doctor and the study protocol."
16115149|NCT02049450|Drug|ruxolitinib|Ruxolitinib was taken at a starting dose of 10 mg twice daily with dose adjustments within the range of 5 to 25 mg twice daily.
16115150|NCT02049437|Drug|tocilizumab|"Subjects will be randomized 1:1 to one of the following arms:
~ARM A: TCZ, 4 mg/Kg by IV infusion over 60 minutes (not to exceed 400 mg) once at study entry, followed by TCZ, 8 mg/Kg by IV infusion over 60 minutes (not to exceed 800 mg) at weeks 4 and 8, and THEN placebo by IV infusion at weeks 20, 24, and 28.
~ARM B: Placebo by IV infusion at study entry followed by placebo by IV infusion at weeks 4 and 8, and THEN TCZ, 4 mg/Kg (not to exceed 400 mg) by IV infusion over 60 minutes once at week 20, followed by TCZ, 8 mg/Kg (not to exceed 800 mg) by IV infusion over 60 minutes at weeks 24 and 28."
16115151|NCT02049437|Drug|Placebo|"Subjects will be randomized 1:1 to one of the following arms:
~ARM A: TCZ, 4 mg/Kg by IV infusion over 60 minutes (not to exceed 400 mg) once at study entry, followed by TCZ, 8 mg/Kg by IV infusion over 60 minutes (not to exceed 800 mg) at weeks 4 aned 8, and THEN placebo by IV infusion at weeks 20, 24, and 28.
~ARM B: Placebo by IV infusion at study entry followed by placebo by IV infusion at weeks 4 and 8, and THEN TCZ, 4 mg/Kg (not to exceed 400 mg) by IV infusion over 60 minutes once at week 20, followed by TCZ, 8 mg/Kg (not to exceed 800 mg) by IV infusion over 60 minutes at weeks 24 and 28."
16115152|NCT02049411|Drug|Ketamine|Ketamine: (dose 0.3 mcg/kg) included in physiological solution at 0.9% (250 ml) during 2 hours, intravenously.
16115153|NCT02049411|Drug|physiological solution|physiological solution at 0.9% (250 ml) during 2 hours, intravenously, with the same physical characteristics of ketamine.
16115154|NCT02049385|Drug|Diazoxide|A nondiuretic vasodilator thiazide-related agent
16115155|NCT02049385|Drug|Placebo|Placebo
16115156|NCT02049359|Other|Texting|Bidirectional texting once weekly for 12 weeks
16115157|NCT02049346|Drug|Epoetin alpha or beta (Epoetin group)|"Erythropoetin doses in that were adjusted according to the approved prescribing information, without additional restrictions.
~Doses of erythropoetin were decreased by 25% for Hb values >12 and ≤13 g/dL and increased by 25% for Hb <11 and ≥10 g/dL. erythropoetin doses were increased by 50% for Hb <10 g/dL. Treatment was interrupted temporarily if Hb exceeds 13 g/dL.
~The doses for all patients were adjusted so that haemoglobin concentrations were maintained within a target range of 11-12 g/dL during the study."
16115158|NCT02049346|Drug|Darbepoetin alfa|"Subjects in that group received Darbepoetin alfa once every week or every 2 weeks as per protocol. Doses of Darbepoetin alfa were decreased by 25% for Hb values >12 and ≤13 g/dL and increased by 25% for Hb <11 and ≥10 g/dL. Darbepoetin alfa doses and increased by 50% for Hb <10 g/dL. Treatment was interrupted temporarily if Hb exceeds 13 g/dL.
~The doses were adjusted so that haemoglobin concentrations were remain within a target range of 11-12 g/dL during the study.
~If a dose of Epoetin alpha/ beta does not equate exactly to a unit dose of Darbepoetin alfa at switching, then the nearest available unit dose of Darbepoetin alfa was used."
16115201|NCT02049034|Other|Placebo|Placebo for lixisenatide is supplied as green and purple colored disposable pen-injectors containing 3 mL of a sterile aqueous solution.
16115202|NCT02049021|Device|MECTA SPECTRUM 5000Q ECT|
16115203|NCT02049021|Procedure|Sham ECT|Sedation using propofol or etomidate and usual ECT preparation (no stimulation)
16115255|NCT02048761|Drug|1 % Metformin gel|After debridement, 1% Metformin gel gel was applied into the periodontal pockets with a syringe and a blunt canula.
16115159|NCT02049346|Drug|Methoxy polyethylene glycol-epoetin beta|"Patients in that arm received Intravenous MIRCERA monthly. The initial dose was 120 mcg, 200 mcg or 360 mcg, for patients had previously received a weekly dose of Epoetin alpha/ beta of less than 8000 IU, between 8000 to16 000 IU or more than16000IU respectively. MIRCERA doses were adjusted according to the approved prescribing information, without additional restrictions.
~Doses of MIRCERA were decreased by 25% for Hb values >12 and ≤13 g/dL and increased by 25% for Hb <11 and ≥10 g/dL. MIRCERA doses were increased by 50% for Hb <10 g/dL. Treatment was interrupted temporarily if Hb exceeds 13 g/dL.
~The doses of MIRCERA were adjusted so that haemoglobin concentrations were maintained within a target range of 11-12 g/dL during the study."
16115160|NCT02049333|Procedure|Phacoemulsification|
16115161|NCT02049333|Procedure|Endoscopic Cycloplasty (ECPL)|
16115162|NCT02049320|Drug|Remifentanil|
16115163|NCT02049307|Drug|Losartan 100mg daily|
16115164|NCT02049307|Drug|Matching placebo|
16115165|NCT02049294|Biological|Omalizumab (Xolair)|
16115166|NCT02049294|Drug|Placebo|
16115167|NCT02049281|Drug|Vintafolide|Intravenous (IV) bolus, starting dose 1.4 mg, on Days 1, 3, 5, 15, 17, and 19 of each 28-day cycle for up to 6 cycles.
16115168|NCT02049268|Drug|Nicotine + Alcohol|14 mg nicotine patch applied in combination with vodka and orange juice alcoholic beverage (to reach blood alcohol level (BAL) = 0.08 based on subject weight, which is approximately 2-3 drinks for 400 mL volume)
16115169|NCT02049268|Drug|Placebo Nicotine + Alcohol|Placebo nicotine patch applied in combination with vodka and orange juice alcoholic beverage (to reach BAL = 0.08 based on subject weight, which is approximately 2-3 drinks for 400 mL volume)
16115170|NCT02049268|Drug|Nicotine + Placebo Alcohol|14 mg nicotine patch applied in combination with 400 mL orange juice beverage with a trace of alcohol to create placebo alcohol mixture.
16115171|NCT02049255|Drug|Chloroprocaine|"The Group Chloroprocaine will receive: Chloroprocaine: 50 mg in rachianesthesia"
16115172|NCT02049255|Drug|Marcaine|"The Group Marcaine will receive: Marcaine: 12,5 mg in rachianesthesia"
16115173|NCT02049242|Procedure|triple tourniquet|"Triple tourniquet consist of two tourniquet applied both infundibulopelvic ligaments and one uterine isthmus to occlude the left and right ovarian vessels and to occlude the uterine arteries. For this purpose, a small opening is made in the avascular place of the broad ligament on either side of the uterine isthmus superior to the uterine vessels. A pediatric Foley catheter is threaded through the two holes and tied tightly anteriorly around the cervix at the level of the internal os.
~Through the same openings in the broad ligament each side a Foley catheter looped around the infundibulopelvic ligament lateral to the fallopian tube and ovary."
16115174|NCT02049242|Procedure|Single tourniquet|Single tourniquet is tourniquet applied uterine isthmus to occlude the uterine arteries. For this purpose, a small opening is made in the avascular place of the broad ligament on either side of the uterine isthmus superior to the uterine vessels. A pediatric Foley catheter is threaded through the two holes and tied tightly anteriorly around the cervix at the level of the internal os.
16115175|NCT02049229|Device|percutaneous coronary intervention|Optimax-stent implantation
16115176|NCT02049229|Device|percutaneous coronary intervention|Synergy stent implantation
16115177|NCT02049216|Other|Flexible tape|Flexible, elasticised, adhesive athletic tape
16115178|NCT02049216|Other|Fixomull|
16115179|NCT02049216|Other|Exercise|Participants in both groups will be prescribed a home exercise program to complete.
16115180|NCT02049203|Drug|Ataciguat|
16115181|NCT02049203|Drug|Placebo|
16115182|NCT02049190|Drug|onapristone|
16115183|NCT02049190|Drug|abiraterone|
16115184|NCT02049164|Drug|AR08|
16115185|NCT02049164|Drug|Placebo|
16115186|NCT02049151|Drug|Tecemotide|Tecemotide injection will be administered once weekly subcutaneously at a dose of 806 microgram up to Week 8 and from Week 14, every 6 weeks until end-of-trial, or until NSCLC progression.
16115187|NCT02049151|Drug|Placebo|Matching placebo injection will be administered once weekly subcutaneously up to Week 8 and from Week 14, every 6 weeks until end-of-trial, or until NSCLC progression.
16115188|NCT02049151|Drug|Cyclophosphamide (CPA)|CPA injection will be administered as a single intravenous infusion at a dose of 300 milligram per square meter (mg/m^2) (to a maximum of 600 mg) 3 days before the first injection of tecemotide.
16115189|NCT02049151|Drug|Saline (sodium chloride)|Matching placebo (saline) injection will be administered as a single intravenous (0.9 percent [%] sodium chloride) infusion 3 days before the first injection of tecemotide-matching placebo.
16115190|NCT02049138|Drug|ABT-494|Tablet; Oral
16115191|NCT02049112|Device|Salivary equivalent|14-day treatment with salivary equivalent sticks
16115192|NCT02049112|Device|Aequasyal|14-day treatment with Aequasyal oral spray
16115193|NCT02049112|Device|Biotene|14-day treatment with Biotene oral spray
16115194|NCT02049086|Behavioral|SBIRT-PM|Screening, Brief Intervention and Referral to Treatment with Pain-Management advice (SBIRT-PM)
16115195|NCT02049086|Behavioral|Pain Module|The pain module of SBIRT-PM with no substance abuse focus (Pain Module Only)
16115196|NCT02049073|Drug|Zonisamide|Zonisamide 100 mg or 200 mg pill administered orally every day for 2 weeks
16115197|NCT02049073|Drug|Methylprednisolone|Methylprednisolone 32 mg or 64 mg pill administered orally once
16115198|NCT02049060|Drug|Tivantinib|"•- 1 level: Tivantinib 120 mg p.o. BID + Carboplatin AUC 5 i.v. day 1 every 3 weeks + Pemetrexed 500 mg/mq i.v. day 1 every 3 weeks
~•0 level: Tivantinib 240 mg p.o. BID + Carboplatin AUC 5 i.v. day 1 every 3 weeks + Pemetrexed 500 mg/mq i.v. day 1 every 3 weeks
~•+ 1 level: Tivantinib 360 mg p.o. BID + Carboplatin AUC 5 i.v. day 1 every 3 weeks + Pemetrexed 500 mg/mq i.v. day 1 every 3 weeks"
16115199|NCT02049047|Drug|Everolimus|Everolimus will be orally administered at the dosage of 10 mg once daily. Each cycle will be considered as 21 days of treatment. Tumor assessment will be done every two cycles.Treatment should be administered until documented disease progression, unacceptable toxicity, or patient refusal.
16115200|NCT02049034|Other|Lixisenatide|"Lixisenatide and placebo are considered as investigational medicinal product (IMP). Metformin is not considered an investigational product but concomitant allowed antidiabetic medications.
~Lixisenatide is supplied as disposable pre-filled pen for subcutaneous injection: 10mcg Lixisenatide green pens; 20 mcg Lixisenatide purple pens. Dose titration-10mcg Lixisenatide for 14 days, 20 mcg for 14 days."
16115616|NCT02046239|Biological|Staple Group (control)|
16115204|NCT02049008|Other|Photodynamic Therapy|After a full-mouth scaling and root planning (SRP), the periodontal pockets of teeth selected to receive antimicrobial photodynamic therapy (aPDT) will be irrigated with distilled water. Shortly thereafter, the dye will be applied (phenothiazine hydrochloride- 10mg/mL) from the bottom of the pocket. After 1 minute, irrigation will be performed with distilled water to remove the excess of dye. The stained area will be irradiated with a diode laser (660 nm and a 60 mW/cm²). Six sites per tooth under treatment will be irradiated (10 seconds/ site). The applications of aPDT will be repeated in the same way until the second week (days: 2, 7,14). Before the application, the supragingival plaque will be removed.
16115205|NCT02049008|Other|Sham Photodynamic Therapy|After a full-mouth scaling and root planning (SRP), the periodontal pockets of teeth selected will receive a simulation of antimicrobial photodynamic therapy (aPDT): irrigation with distilled water and simulated laser application. The simulations of aPDT will be repeated in the same way until the second week (days: 2, 7,14). Before the application, the supragingival plaque will be removed.
16115206|NCT02048982|Behavioral|Guideline|Physicians will receive information on the Choosing Wisely Guideline
16115207|NCT02048982|Behavioral|Cost|Physicians will receive cost information.
16115208|NCT02048982|Behavioral|Victim|Physicians will receive information on an identifiable victim.
16115209|NCT02048969|Drug|Flumazenil|A priming dose bolus of 0.4 mg of flumazenil will be administered intravenously (Minute 0). At this time the 1H-MRS scan will begin. Over the next 6 minutes, a drip infusion of placebo mixed with saline will be administered to the patient at a rate of 0.1 mg per minute for a total of 7 doses during the scan. Total dose will be 1.0 mg.
16115210|NCT02048969|Drug|Placebo|A priming dose bolus of 0.4 mg of placebo will be administered intravenously (Minute 0). At this time the 1H-MRS scan will begin. Over the next 6 minutes, a drip infusion of placebo mixed with saline will be administered to the patient at a rate of 0.1 mg per minute for a total of 7 doses during the scan. Total dose will be 1.0 mg.
16115211|NCT02048956|Other|Hydrotherapy intervention|Participants randomized to the exercise programme received a training in a swimming pool focused on dance therapy.
16115212|NCT02048956|Other|Control group|Standard exercises of hydrotherapy
16115213|NCT02048943|Drug|dovitinib lactate|Given PO
16115214|NCT02048943|Drug|gemcitabine hydrochloride|Given IV
16115215|NCT02048943|Drug|paclitaxel albumin-stabilized nanoparticle formulation|Given IV
16115216|NCT02048943|Other|pharmacological study|Correlative studies
16115217|NCT02048943|Other|laboratory biomarker analysis|Correlative studies
16115218|NCT02048930|Device|Budesonide Easyhaler|
16115219|NCT02048930|Device|Budesonide dry powder inhaler|
16115220|NCT02048917|Drug|High Intensity Counseling + Long Acting NRT + PRN NRT|High Intensity Counseling + Long Acting NRT + PRN NRT
16115221|NCT02048917|Drug|High Intensity Counseling + bupropion + PRN NRT|High Intensity Counseling + bupropion + PRN NRT
16115222|NCT02048917|Drug|High Intensity Counseling + varenicline + PRN NRT|High Intensity Counseling + varenicline + PRN NRT
16115223|NCT02048917|Drug|High Intensity Counseling + Long Acting NRT|High Intensity Counseling + Long Acting NRT
16115224|NCT02048917|Drug|High Intensity Counseling + bupropion|High Intensity Counseling + bupropion
16115225|NCT02048917|Drug|High Intensity Counseling + varenicline|High Intensity Counseling + varenicline
16115226|NCT02048917|Drug|Low Intensity Counseling + Long Acting NRT + PRN NRT|Low Intensity Counseling + Long Acting NRT + PRN NRT
16115227|NCT02048917|Drug|Low Intensity Counseling + bupropion + PRN NRT|Low Intensity Counseling + bupropion + PRN NRT
16115228|NCT02048917|Drug|Low Intensity Counseling + varenicline + PRN NRT|Low Intensity Counseling + varenicline + PRN NRT
16115229|NCT02048917|Drug|Low Intensity Counseling + Long Acting NRT|Low Intensity Counseling + Long Acting NRT
16115230|NCT02048917|Drug|Low Intensity Counseling + bupropion|Low Intensity Counseling + bupropion
16115231|NCT02048917|Drug|Low Intensity Counseling + varenicline|Low Intensity Counseling + varenicline
16115232|NCT02048904|Drug|Sitagliptin|Sitagliptin 100 mg/day for 3 months
16115233|NCT02048904|Drug|Placebo|Placebo 1 pill/day for 3 months
16115234|NCT02048891|Drug|GnRH agonist trigger|
16115235|NCT02048891|Drug|hCG trigger|
16115236|NCT02048865|Drug|Apixaban|Apixaban 2.5 mg tablets BID for 6 months
16115237|NCT02048865|Drug|Placebo drug|placebo drug 2.5mg BID for 6 months
16115238|NCT02048852|Other|Reduced Nicotine Content- Non Menthol|Switch from own brand of cigarette to a research cigarette with a Reduced Nicotine Content of 0.07mg nicotine yield without menthol.
16115239|NCT02048852|Other|Reduced Nicotine Content- Menthol|Switch from own brand of cigarette to Reduced nicotine level of each research cigarette to 0.07mg nicotine yield with Menthol
16115240|NCT02048852|Other|Conventional Nicotine Content- Menthol|Allow own brand of Conventional Nicotine-Menthol Cigarette
16115241|NCT02048852|Other|Conventional Nicotine Content- Non Menthol|Switch from own cigarette to a research cigarette which contains Conventional Nicotine yield.
16115242|NCT02048826|Device|FINGER I|FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting I
16115243|NCT02048826|Device|FINGER II|FINGER is a robot that measures finger movements and allows patients to play computer game using those movements. Patients will be exercising with FINGER using setting II
16115244|NCT02048813|Drug|Cyclophosphamide|Given IV
16115245|NCT02048813|Drug|Fludarabine Phosphate|Given IV
16115246|NCT02048813|Drug|Ibrutinib|Given PO
16115247|NCT02048813|Other|Laboratory Biomarker Analysis|Correlative studies
16115248|NCT02048813|Other|Pharmacogenomic Study|Correlative studies
16115249|NCT02048813|Other|Quality-of-Life Assessment|Ancillary studies
16115250|NCT02048813|Biological|Rituximab|Given IV
16115251|NCT02048800|Drug|Treosulfan|Treosulfan will be administered over 3 days prior to HSCT at the following dose: 10 g/m2 (children aged < 3months) or 12 g/m2 (children aged 3/12 months) or 14 g/m2 (children aged > 12 months)
16115252|NCT02048787|Drug|Buparlisib|Subjects will receive a single dose of 50 mg buparlisib.
16115253|NCT02048774|Behavioral|Designation of Social Positioning|
16115254|NCT02048761|Drug|Placebo gel|After debridement, a single dose of the placebo gel was applied into the periodontal pockets with a syringe and a blunt canula
16115256|NCT02048748|Device|Weight and blood pressure device|Weight and blood pressure device integrated in a home telemonitoring kit. The weight scale is Withings The Smart Bodyscale. The blood pressure device is MEDISANA iHealth BP3.
16115257|NCT02048748|Device|Home telemonitoring device|An iPad 2 WiFi 16GB (Model A1395) tablet integrating the telemonitoring kit.
16115258|NCT02048722|Drug|regorafenib|Given PO
16115259|NCT02048709|Drug|GDC-0919|Supplied in 50 mg and 200 mg capsules. To be taken every 12 hours with water by mouth on an empty stomach (no food or drink other than water for 2 hours prior to dose). Taken twice daily for 21 days each cycle, followed by 7 days off; or taken twice daily on 28 consecutive days of a 28-day cycle
16115260|NCT02048696|Other|Secondary prevention and cardiac rehabilitation clinic|Secondary prevention and cardiac rehabilitation clinic of the Montreal Heart Institute. Subjects will undergo twice weekly exercise training with high intensity interval training for a period of 12 weeks.
16115261|NCT02048683|Drug|Short term sedation with sevoflurane in ICU|
16115262|NCT02048670|Device|Balance Belt|Vestibular habituation therapy worn under the clothes around the waist that uses sensitive motion detectors and vibrates against the skin at four locations to provide information about posture and gait
16115263|NCT02048657|Device|Foley Airway Stylet Tool|
16115264|NCT02048657|Device|introducer-tool|
16115265|NCT02048644|Drug|fostair|beclometasone dipropionate 200mcg and formoterol 12 mcg delivered by inhaler, twice a day for 28 days
16115266|NCT02048644|Drug|placebo|placebo matched inhaler 2puffs to be taken twice a day for 28 days
16115267|NCT02048618|Drug|GLPG0634|100 mg oral tablet, intake once daily for 20 weeks
16115268|NCT02048618|Drug|Placebo|placebo oral tablets, intake once daily for 20 weeks
16115269|NCT02048605|Behavioral|Psycho-social CBT based training|Number of Sessions: 9x Content: cognitive behavioral group-training-program to reduce stress and augment quality of life.
16115270|NCT02048605|Behavioral|Unspecific group training|Number of sessions: 9x Content: Music or Art Therapy Nutrition Education around Food Functional Movement Physical Activity Group discussion
16115271|NCT02048592|Dietary Supplement|Impact-Nutridrink|"IMPACT (immunonutrition) will be given in the first 8 weeks. Afterwards the patients will be returned to their previous nutrition support |(Nutridrink) for another 8 weeks."
16115272|NCT02048592|Dietary Supplement|Nutridrink-Impact|In this group of patients - the study starts with period of 8 weeks with no change of previous nutrition support (Nutridrink). After 8 weeks the laboratory results will be examined ant the patients will switch to immunonutrition (Impact) for another 8 weeks. After the laboratory examination including oxidative stress parameters will be evaluated.
16115273|NCT02048579|Behavioral|Behavior Therapy + Motivational Interviewing|
16115274|NCT02048566|Device|ImaCor PM|The ImaCor ClariTEE (hTEE) device is a transesophageal echocardiography system. It produces a single-plane two-dimensional image. The ImaCor probe is a 5.5 mm detachable probe; it can remain in situ for up to 72h and allows for reassessment of the patient's hemodynamic progress and the effect of selected interventions at any time. The probe is connected to a dedicated echocardiographic system which allows the for the recording of digital loops and performance of basic two-dimensional measurements. ImaCorPM subjects will receive echocardiography-guided hemodynamic management (hTEE) at the time of inclusion, at the time of occurrence of defined new organ system deterioration and/or at least every 4 hours during the first 72h after study inclusion or until one of the following events occurs: study primary endpoints reached, patient is extubated, withdrawal of active treatment.
16115275|NCT02048566|Device|ImaCor SM|The ImaCor ClariTEE (hTEE) device is a transesophageal echocardiography system. It produces a single-plane two-dimensional image. The ImaCor probe is a 5.5 mm detachable probe; it can remain in situ for up to 72h and allows for reassessment of the patient's hemodynamic progress and the effect of selected interventions at any time. The probe is connected to a dedicated echocardiographic system which allows the for the recording of digital loops and performance of basic two-dimensional measurements. ImaCorSM subjects will receive echocardiography-guided hemodynamic management (hTEE) at the time of inclusion, follow-up assessment intervals are at the discretion of the treating physician for the first 72h after study inclusion. hTEE monitoring is discontinued if one of the following events occurs: study primary endpoints reached, patient is extubated, withdrawal of active treatment.
16115276|NCT02048566|Other|Control PM|Group Control protocolized monitoring (ControlPM) will receive any hemodynamic monitoring of choice of the treating physician except ImaCor. Protocolized hemodynamic assessments will be performed at the time of inclusion, at the time of occurrence of defined new organ system deterioration or at least every 4 hours for the first 72h after study inclusion. Protocolized monitoring is discontinued if one of the following events occurs: study primary endpoints reached, patient is extubated, withdrawal of active treatment.
16115277|NCT02048566|Other|Control SM|Group Control standard monitoring (ControlSM) will receive any hemodynamic monitoring of choice of the treating physician except ImaCor. Protocolized hemodynamic assessments will be performed at the time of inclusion, follow-up measurement intervals are at the discretion of the treating physician for the first 72h. Data collection from standard monitoring is discontinued if one of the following events occurs: study primary endpoints reached, patient is extubated, withdrawal of active treatment.
16115278|NCT02048553|Device|Tablet-guided ventriculostomy|"In patients of the treatment group, ventriculostomy will be performed using a mini-tablet-guided assistance based on preoperative CT imaging. Any patient meeting the inclusion criteria and not violating the exclusion criteria may participate in the TABGUIDE study and be randomized to either a guided or freehand ventriculostomy, thus defining the two distinct groups  guided  or  freehand )."
16115279|NCT02048553|Procedure|Freehand|Patients in the control group will receive standard free-hand ventriculostomy using anatomical landmarks. The catheter may be placed for external drainage or internal (ventriculoperitoneal) shunting in both groups.
16115280|NCT02048540|Biological|Bevacizumab|Bev (5 mg/kg, d1) every 3 weeks, up to 2-4 cycles preoperation, and another 2-4 cycles postoperation up to total 6 cycles.
16115281|NCT02048540|Drug|docetaxel oxaliplatin 5-FU CF|docetaxel, 75 mg/m2, iv, d1; oxaliplatin, 85 mg/m2, iv, d1; 5-FU, iv infusion 600 mg/m2 and iv injection 400mg/m2, d1-2; CF, 200 mg/m2, d1 and d2 each 3-week, up to 2-4 cycles preoperation, and another 2-4 cycles postoperation up to total 6 cycles.
16115282|NCT02048540|Procedure|Gastrectomy|
16115283|NCT02048527|Other|Global|Single medium for the culture of embryos from Day1 to Day 5
16115416|NCT02047539|Drug|Aspirin|1000 mg/day of aspirin 1000 mg/day of sugar pill
16115284|NCT02048527|Other|Origio|Sequential media medium for the culture of embryos from Day1 to Day 3 (ISM1) and from Day 3 to Day 5 (BlastAssist)
16115285|NCT02048514|Device|The Nellix® EndoVascular Aneurysm Sealing System|
16115286|NCT02048501|Other|Resting Metabolic Rate (RMR)|Each subject will have their resting metabolic rate (RMR) measured. The RMR is assessed by indirect calorimetry measured with the metabolic cart. Oxygen consumption is converted into kilocalories. Subjects will be advised to avoid strenuous exercise for at least 48 hours prior to participation in the study and to sleep at least 6-8 hours the night before. Smoking and consuming caffeine will be prohibited 12 hours before the study begins.
16115287|NCT02048501|Other|Duel-energy x-ray absorptiometry (DEXA)|During a separate appointment on the same day, or within 7 business days if same day is not possible, a body compositions analysis, including fat mass and fat free mass, will be assessed by dual-energy x-ray absorptiometry (DEXA), using a Hologic system.
16115288|NCT02048501|Other|Visual Analog Scale (VAS)|Subjects will be asked to complete a 100-mm Visual Analog scale (VAS) to assess their appetite. The VAS will be completed prior to the meal stimulation test and at 30-minutes, 1-hour, 90 minutes and 2-hours after the meal. The VAS will contain questions assessing food intake, appetite, and hunger.
16115289|NCT02048501|Other|Meal Stimulation Test|Subjects will consume a mixed-nutrient liquid meal 240-ml in 20 minutes. Prior to the meal stimulation test, a baseline 10-ml blood sample will be collected. The, during the meal stimulation test, 10-ml venous blood sample will be collected at 30 minute intervals up to two hours, for a total of 5 samples including the baseline sample. The blood samples will be used to measure fasting blood glucose, adipokines, myokines, gut hormones, amino acids, bile acids, vitamin B and vitamin D analysis with the appropriate assay method.
16115290|NCT02048488|Drug|TSR-011|Number of cycles until progression or unacceptable toxicity develops.
16115291|NCT02048475|Other|desflurane|changing concentration
16115292|NCT02048423|Drug|Ketamine|IV Ketamine, 0.5 mg/kg X 15 mins. in PACU
16115293|NCT02048410|Dietary Supplement|Lactobacillus paracasei B21060|combination of probiotic (Lactobacillus paracasei B21060) and prebiotics (arabinogalactans, xyloooligosaccarides) and amine (L-glutamine)
16115294|NCT02048410|Other|low satured diet|
16115295|NCT02048397|Other|Pulmonary Rehabilitation|
16115296|NCT02048397|Dietary Supplement|Hyperproteic oral nutritional supplement enriched with beta-hydroxy-beta-methylbutyrate|
16115297|NCT02048384|Drug|metformin alone (Arm A)|metformin alone
16115298|NCT02048384|Drug|metformin (Arm B)|rapamycin + metformin
16115299|NCT02048384|Drug|rapamycin (Arm B)|rapamycin + metformin
16115300|NCT02048371|Drug|Regorafenib|Adults: 160 mg daily; 21 days on and 7 days off Pediatrics: 82mg/m2 (rounding to the nearest 20mg) daily; 21 days on and 7 days off
16115301|NCT02048371|Drug|Placebo|21 days on and 7 days off
16115302|NCT02048358|Drug|2B3-201|
16115303|NCT02048358|Drug|Placebo|
16115304|NCT02048358|Drug|Methylprednisolone hemisuccinate|
16115305|NCT02048345|Drug|Suspension Fasted State|
16115306|NCT02048345|Drug|Suspension Fed State|
16115307|NCT02048345|Drug|Solution Fasted State|
16115308|NCT02048345|Drug|Solution Fed State|
16115309|NCT02048332|Biological|Viral specific VST Infusion|"VSTs will be infused into stem cell transplant recipients who have evidence of viral infection or reactivation defined as any of the following:
~Blood adenovirus PCR ≥ 1,000
~Blood CMV PCR ≥ 500
~Blood EBV PCR ≥ 9,000
~Plasma BKV PCR >1,000
~Plasma JC Virus PCR >1,000
~Evidence of invasive adenovirus infection or disease, defined as the presence of adenoviral positivity in one or more sites.
~Evidence of invasive CMV infection, eg pneumonitis, retinitis, colitis
~Evidence of EBV-associated lymphoproliferation (EBV-LPD) defined as proven EBV-LPD by biopsy or probable EBV-LPD defined as an elevated EBV DNA level in the blood associated with clinical symptoms (adenopathy or fever or masses on imaging) but without biopsy confirmation, or EBV-associated malignancies.
~Evidence of symptomatic BK virus infection, which may include symptomatic hemorrhagic cystitis, or BK nephropathy.
~Evidence of PML or other CNS infection due to JC virus."
16115310|NCT02048319|Drug|Pasireotide LAR 60 mg|Pasireotide long acting release, intramuscular injection
16115311|NCT02048319|Procedure|Aspiration sclerotherapy|Percutaneous drainage of the hepatic cyst with subsequent ethanol instillation
16115312|NCT02048319|Drug|Placebo|Saline solution, injected as placebo
16115313|NCT02048306|Behavioral|Family-based PR program|The 12-week Family-based PR program will consist of psychoeducation for patients and family members (once a week) and exercise training for patients (3 times a week). The psychoeducation component aims to empower the family with strategies to facilitate a functional and healthy adjustment to the disease and includes educational and psychosocial support components.
16115314|NCT02048306|Behavioral|Conventional PR program|The 12-week Conventional PR program will consist of psychoeducation (once a week) and exercise training (3 times a week) for patients only.
16115315|NCT02048293|Drug|Remifentanyl, Ultiva®|Anesthetic induction for orotracheal intubation. Group O
16115316|NCT02048293|Drug|Remifentanil Laboratorios Chalver de Colombia S.A.|Anesthetic induction for orotracheal intubation. Group A
16115317|NCT02048293|Drug|Fada Remifentanilo|Anesthetic induction for orotracheal intubation. Group B
16115318|NCT02048280|Procedure|NAVA level|Peak inspiratory pressure will be measured at each NAVA level
16115319|NCT02048280|Other|NAVA level|Increase NAVA level every 3 minutes
16115320|NCT02048267|Procedure|Frey's procedure/Pylorus preserving pancreatoduodenectomy|Duodenum preserving head resection
16115321|NCT02048254|Radiation|brachytherapy|
16115322|NCT02048254|Radiation|IMRT|
16115323|NCT02048241|Behavioral|Parent Management Training|This is a psychological treatment that focuses on decreasing tantrums and outbursts by reducing the ability of the tantrum to coerce parents into giving in to the demand that precipitated the tantrum.
16115324|NCT02048241|Other|Placebo|Weekly dispensation of pills matching Intuniv but without the active medication
16115325|NCT02048241|Drug|Intuniv|Weekly administration of medication in doses as per protocol
16115326|NCT02048228|Drug|genotyping guided therapy Ticagrelor, Clopidogrel|CYP2C19*2 carriers will be given 90 mg ticagrelor twice daily, and non-carriers and patients in the standard treatment group will be given 75 mg clopidogrel daily.
16115327|NCT02048228|Drug|standard therapy clopidogrel|All patients will be administrated with clopidogrel 75 mg daily for 5 consecutive days.
16115328|NCT02048215|Drug|Caffeine|Patients are randomised to 30-day treatment with either EC (200/20mg t.i.d.) or placebo. The EC administration starts with an initial dose of 100/10 mg t.i.d. for the first week and then proceeds with the full dose of 200/20 mg t.i.d. Patients are hospitalised during the whole treatment period, at the metabolic unit of San Giuseppe Hospital-Istituto Auxologico Italiano at Piancavallo (VB, Italy). During the treatment period all patients are fed a hypocaloric diet (total energy content of ~70% of energy expenditure, as measured by indirect calorimetry), and containing 20% proteins, 55% carbohydrates, 25% fat half of which was monounsaturated, and 35 g/day fibres.
16115329|NCT02048215|Drug|Placebo|Patients are randomised to 30-day treatment with either EC (200/20mg t.i.d.) or placebo. The EC administration starts with an initial dose of 100/10 mg t.i.d. for the first week and then proceeds with the full dose of 200/20 mg t.i.d. Patients are hospitalised during the whole treatment period, at the metabolic unit of San Giuseppe Hospital-Istituto Auxologico Italiano at Piancavallo (VB, Italy). During the treatment period all patients are fed a hypocaloric diet (total energy content of ~70% of energy expenditure, as measured by indirect calorimetry), and containing 20% proteins, 55% carbohydrates, 25% fat half of which was monounsaturated, and 35 g/day fibres.
16115330|NCT02048215|Drug|Ephedrine|Patients are randomised to 30-day treatment with either EC (200/20mg t.i.d.) or placebo. The EC administration starts with an initial dose of 100/10 mg t.i.d. for the first week and then proceeds with the full dose of 200/20 mg t.i.d. Patients are hospitalised during the whole treatment period, at the metabolic unit of San Giuseppe Hospital-Istituto Auxologico Italiano at Piancavallo (VB, Italy). During the treatment period all patients are fed a hypocaloric diet (total energy content of ~70% of energy expenditure, as measured by indirect calorimetry), and containing 20% proteins, 55% carbohydrates, 25% fat half of which was monounsaturated, and 35 g/day fibres.
16115331|NCT02048215|Other|Hypocaloric diet|Patients are randomised to 30-day treatment with either EC (200/20mg t.i.d.) or placebo. The EC administration starts with an initial dose of 100/10 mg t.i.d. for the first week and then proceeds with the full dose of 200/20 mg t.i.d. Patients are hospitalised during the whole treatment period, at the metabolic unit of San Giuseppe Hospital-Istituto Auxologico Italiano at Piancavallo (VB, Italy). During the treatment period all patients are fed a hypocaloric diet (total energy content of ~70% of energy expenditure, as measured by indirect calorimetry), and containing 20% proteins, 55% carbohydrates, 25% fat half of which was monounsaturated, and 35 g/day fibres.
16115332|NCT02048189|Drug|LEVEMIR|
16115333|NCT02048189|Drug|APIDRA|
16115334|NCT02048150|Biological|anti-PSMA monoclonal antibody MDX1201-A488|Given IV
16115335|NCT02048150|Procedure|robot-assisted laparoscopic surgery|Undergo RALP
16115336|NCT02048150|Other|diffuse optical imaging|Undergo IOOI
16115337|NCT02048150|Other|pharmacological study|Correlative studies
16115338|NCT02048150|Other|Laboratory Biomarker|Correlative studies
16115339|NCT02048150|Other|Questionnaire|Ancillary studies
16115340|NCT02048137|Device|Transcranial direct current stimulation|
16115341|NCT02048124|Device|25g standard needle|
16115342|NCT02048124|Device|25d ProCor needle|
16115343|NCT02048111|Biological|IB1001|"Prophylaxis (during Treatment and Continuation phases): 40 - 75 IU/kg twice weekly.
~The starting dose for prophylaxis may be based on previous recombinant factor IX product use. The recommended starting prophylaxis dose is 40 - 60 IU/kg twice weekly, however, the investigator may prescribe up to 75 IU/kg twice weekly at their discretion (after clinically assessing the subject) and discretion of the subject.
~The dose or the frequency of IB1001 prophylaxis may be adjusted at the discretion of the investigator."
16115344|NCT02048098|Drug|Vaginal misoprostol|400 µg vaginal misoprostol per 3 hours up to 6 doses. The treatment will be withold if the patient has strong uterine contractions. If abortion had not occured in 24 hour after the start of the study a second course of 400 µg vaginal misoprostol per 3 hours up to 6 doses will be administered. If abortion had not occured in 48 hour after the start of the study it will be considered treatment failure and patient will be offered another induction/delivery method or to continue protocol.
16115345|NCT02048098|Drug|Buccal misoprostol|400 µg buccal misoprostol per 3 hours up to 6 doses. The treatment will be withold if the patient has strong uterine contractions. If abortion had not occured in 24 hour after the start of the study a second course of 400 µg buccal misoprostol per 3 hours up to 6 doses will be administered. If abortion had not occured in 48 hour after the start of the study it will be considered treatment failure and patient will be offered another induction/delivery method or to continue protocol.
16115346|NCT02048085|Drug|Ticagrelor|For ticagrelor arm, randomized STEMI patients with a history of fibrinolysis within last 24-48 and undergoing PCI will be loaded with ticagrelor 180 mg prior to PCI followed by maintenance dose of 90 mg bid.
16115347|NCT02048085|Drug|Clopidogrel|For clopdigrel arm, randomized STEMI patients with a history of fibrinolysis within last 24-48 and undergoing PCI will be loaded with clopidogrel 300 mg prior to PCI followed by maintenance dose of 75 mg QD
16115348|NCT02048072|Drug|Gilenya|Autonomic testing during first dose administration of Gilenya.
16115349|NCT02048059|Drug|ANG1005|
16115350|NCT02048033|Device|Regular endoscopy + endogastric suturing|Patients will get the usual endoscopy used for diagnosis. In addition, they will receive an endoscopic surgery using the APOLLO Endosuregery technique. The Apollo Endosurgery OverStitch is an endoscopic equipment which involves the suturing by endogastric way to decrease the size of the anastomosis gastrojujenal or gastric pouch
16115351|NCT02048033|Diagnostic Test|Regular endoscopy|Patients will get the usual endoscopy used for diagnosis.
16115352|NCT02048020|Drug|paclitaxel|Given IV
16115353|NCT02048020|Drug|carboplatin|Given IV
16115354|NCT02048020|Radiation|intensity-modulated radiation therapy|Undergo IMRT
16115355|NCT02048020|Procedure|quality-of-life assessment|Ancillary studies
16115356|NCT02048007|Drug|Azithromycin|Biannual mass oral azithromycin to children
16115357|NCT02048007|Drug|Placebo|Biannual mass oral placebo to children
16115358|NCT02047994|Drug|Triple therapy|"Participants who are positive with Helicobacter pylori in Group1 will receive triple therapy.
~Esomeprazole 40 mg bid for 10 days
~Clarithromycin 500 mg bid for 10 days
~Amoxicillin 1000 mg bid for 10 days"
16115359|NCT02047981|Drug|Azithromycin|Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral azithromycin suspension every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.
16115417|NCT02047539|Drug|Placebo|
16115360|NCT02047981|Drug|Placebo|Children aged 1 month to 60 months per community will be offered weight or height-based, directly observed, oral placebo every 6 months for 2 years. In Niger during year 3, all communities will be offered azithroymcin.
16115361|NCT02047968|Behavioral|wake therapy|
16115362|NCT02047955|Procedure|Shoulder Arthroplasty|
16115363|NCT02047942|Behavioral|Center-based cardiac rehabilitation|
16115364|NCT02047942|Behavioral|Home-based training with telemonitoring guidance|
16115365|NCT02047929|Other|Asthma Shared Decision Making (SDM) Toolkit|A potential solution to improving asthma outcomes is the use of patient-centered approaches like Shared Decision Making (SDM), In the SDM process, patients and their health care providers are engaged jointly in making decisions about medical tests and treatments. The research team for this proposal was funded by the Agency for Health Care Research and Quality to build, disseminate and evaluate a novel Asthma SDM Toolkit - The Asthma Comparative Effectiveness Study. The Toolkit development was completed in 2010 and has been in evaluation for 2 years. This study will continue to evaluate the Toolkit in a wide array of practices across NC while testing a new method of dissemination.
16115366|NCT02047903|Drug|Afatinib|50, 40, 30 or 20 mg
16115367|NCT02047890|Drug|BAY1000394 (2.5mg)|BAY1000934 2.5mg twice a day (bid) in a 3 days on and 4 days off schedule. (Cohort 1)
16115368|NCT02047890|Drug|BAY1000394 (5mg)|BAY1000934 5mg twice a day (bid) in a 3 days on and 4 days off schedule. (Cohort 2)
16115369|NCT02047864|Dietary Supplement|Creatine monohydrate|
16115370|NCT02047851|Other|Acupuncture|Patients are randomized to real acupuncture or sham acupuncture if they are in the intervention group
16115371|NCT02047838|Other|Anti-mullerian hormone (AMH) level dosage.|
16115372|NCT02047838|Other|Follicle-stimulating hormone (FSH) level dosage.|
16115373|NCT02047838|Other|Antral follicle count (AFC).|
16115374|NCT02047825|Other|Upper limbs intervention|An 8-week intervention with different exercises will be performed. This intervention will focus on upper limbs. The exercises will include plaster of resistance, elastic bands and other exercises.
16115375|NCT02047825|Other|Usual treatment|Occupational therapy and physiotherapy, twice a week, as usual.
16115376|NCT02047799|Dietary Supplement|Calcitriol|Subjects whom were enrolled for 6 weeks of treatment with a daily dose of Calcitriol (1000 UI)
16115377|NCT02047799|Dietary Supplement|Control|Subjects whom were enrolled for 6 weeks of treatment with a daily dose of Placebo
16115378|NCT02047773|Other|Duration|If bacterial load checked on day 7 is less than 10^6 cfu/ml then antibiotics will be stopped on day 8 (results take 24hrs). If bacterial load remains higher than this then patients will continue on intravenous antibiotics. Bacterial load will be checked again on day 10. If bacterial load is less than 10^6 cfu/ml then antibiotics will be stopped on day 11. If bacterial load remains higher than this then the patient will complete a 14day course of antibiotics. All patients will be seen and bacterial load assessed on day 1, day 7, day 10, day 14 and day 21.
16115379|NCT02047773|Drug|Colomycin|If there is a clinical deterioration a second antibiotic to augment treatment (Colomycin) will be added for both arms of the study.
16115380|NCT02047773|Drug|Meropenem|
16115381|NCT02047747|Drug|Dacomitinib|Dacomitinib 45 mg will be administered orally daily. Treatment cycles will consist of 28 days.
16115382|NCT02047734|Drug|Ozanimod|Oral capsule, daily for 24 months
16115383|NCT02047734|Drug|Ozanimod placebo|Oral capsule, daily for 24 months
16115384|NCT02047734|Drug|Interferon beta-1a|Intramuscular injection, 30 µg, weekly for 24 months
16115385|NCT02047734|Drug|Interferon beta-1a placebo|Intramuscular injection, weekly for 24 months
16115386|NCT02047721|Behavioral|Exercise|The intervention gradually increases EE from 150-200 kcal/day 5 days per week to a target of 400 kcal/d 5 days per week and will last a total of 12 weeks.
16115387|NCT02047721|Behavioral|Diet|A supervised diet program which has been successfully implemented by our group with a goal being to reduce energy intake by ~2000 kcal/week.
16115388|NCT02047708|Drug|Zibotentan|Selective endothelin-A antagonist
16115389|NCT02047682|Behavioral|Biopsychosocial|
16115390|NCT02047682|Behavioral|Reference|
16115391|NCT02047669|Behavioral|Biopsychosocial|
16115392|NCT02047669|Behavioral|Reference|
16115393|NCT02047656|Drug|LFF269|LFF269 capsules twice daily (b.i.d)
16115394|NCT02047656|Drug|Placebo to LFF269|Placebo LFF269 b.i.d for 10 days in healthy volunteers
16115395|NCT02047643|Device|Computer algorithm to initiate pump suspension|If the computer algorithm senses impending risk for hypoglycemia it sends an alert to an on-site physician to recommend a manual suspension of the subject's insulin pump
16115396|NCT02047630|Drug|Generic latanoprost|
16115397|NCT02047630|Drug|Brand-name latanoprost|
16115398|NCT02047617|Device|the standard physiotherapy group|Mobilization and rehabilitation program is progressively introduced after clinical stabilization
16115399|NCT02047617|Device|standing table group|The protocol involved a stepwise process to gradually raise the subject into a standing position on the standing table platform
16115400|NCT02047604|Drug|SAN-300 0.5 mg/kg QW|
16115401|NCT02047604|Drug|SAN-300 1.0 mg/kg QW|
16115402|NCT02047604|Drug|SAN-300 2.0 mg/kg QOW|
16115403|NCT02047604|Drug|SAN-300 4.0 mg/kg QOW|
16115404|NCT02047604|Drug|SAN-300 4.0 mg/kg QW|
16115405|NCT02047604|Drug|Placebo|
16115406|NCT02047578|Drug|Busulfan|First dose: busulfan (120 mg/m2 ivs once daily) (if age<1 yr: 80 mg/ m2) Second to forth dose: according to the daily pharmacokinetic study
16115407|NCT02047565|Drug|60mg edoxaban|
16115408|NCT02047565|Drug|180mg edoxaban|
16115409|NCT02047565|Drug|50 IU/kg Beriplex P/N|
16115410|NCT02047565|Drug|25 IU/kg Beriplex P/N|
16115411|NCT02047565|Drug|10 IU/kg Beriplex P/N|
16115412|NCT02047552|Drug|Iron sucrose|Iron sucrose 100 mg IV will be dosed daily for up to seven days if, on morning laboratory analysis, (1) TSAT < 25%, (2) Serum iron concentration < 150 ug/mL, and (3) Serum ferritin concentration < 1,500 ng/mL. Thus, the maximum possible cumulative dose of iron sucrose over the one-week dosing period will be 700 mg.
16115413|NCT02047552|Drug|Oxandrolone|10 mg PO Q12 hours for seven days
16115414|NCT02047552|Drug|IV iron placebo|100 mL normal saline
16115415|NCT02047552|Drug|Oxandrolone placebo|similar color and size sugar pill
16115418|NCT02047513|Drug|perioperative nab-paclitaxel/gemcitabine|2 cycles of nab-paclitaxel/gemcitabine (nab-paclitaxel 125 mg/m2, gemcitabine 1000 mg/m2 on day 1, 8 and 15 of an 28 day-cycles) followed by 3 weeks of rest and subsequent tumor surgery. Starting within 12 weeks after surgery adjuvant chemotherapy with 4 cycles of nab-paclitaxel/gemcitabine (nab-paclitaxel 125 mg/m2, gemcitabine 1000 mg/m2 on day 1, 8 and 15 of an 28 day-cycles)
16115419|NCT02047513|Drug|adjuvant nab-paclitaxel/gemcitabine|Tumor surgery followed by adjuvant chemotherapy with 6 cycles of nab-paclitaxel/gemcitabine (nab-paclitaxel 125 mg/m2, gemcitabine 1000 mg/m2 on day 1, 8 and 15 of an 28 day-cycles, starting within 12 weeks after surgery)
16115420|NCT02047500|Drug|TH-302|TH-302 will be administered at a dose ranging from 170-340 milligram per square meter (mg/m^2) as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.
16115421|NCT02047500|Drug|Nab-paclitaxel|Nab-paclitaxel will be administered at a dose ranging from 100-125 mg/m^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.
16115422|NCT02047500|Drug|Gemcitabine|Gemcitabine will be administered at a dose ranging from 800-1000 mg/m^2 as intravenous infusion over 30 minutes on Days 1, 8 and 15 of every 28-day cycle until evidence of progressive disease, intolerable toxicity or subject withdrawal.
16115429|NCT02047461|Drug|ORGN001 (formerly ALXN1101)|IV infusion
16115430|NCT02047448|Procedure|Pharmacist Counseling|The hospital pharmacist will meet with the patient and complete medication reconciliation, assess the patient's understanding of the medications, and identify medication-related problems. The hospital pharmacist will complete a pharmacist discharge care plan and a copy will be sent to the participating community pharmacist. The patients will be scheduled for the first meeting with their community pharmacist within 1 week of hospital discharge. The community pharmacist will interview the patient about their general health and any current symptoms of heart failure or COPD, identify any additional medication-related problems, follow-up on any issues as described in the pharmacist discharge care plan, and provide patient education. The patients will then meet with their community pharmacist for counseling and patient education at monthly intervals for 6 months following hospital discharge.
16115431|NCT02047435|Behavioral|Information, event and workshops at a cartoon museum|"An event at the Storm P. Museum consisting of:
~A guided tour at the museum
~A representative from the municipal DaneAge Association will tell about the municipality's activities for the elderly.
~The museum serves a refreshment and offer participants a season pass to the museum.
~And
~Workshops at The Storm P. museum, for up to 12 months with approximately two workshops a months. In collaboration with the museum the participants create memory material for nursing home resident with dementia. The workshop will use narrative as a method to give participants a mutual relationship that is perceived as meaningful and rewarding for each participant and in the dialogues a mutual understanding is created. The museum staff facilitates the process of storytelling using events, significant stories and artistic works by Storm P., to encourage the participants, via the method known as narrative interview, to share similar stories from their life."
16115432|NCT02047435|Behavioral|Information and event at a cartoon museum|"1. An event at the Storm P. Museum consisting of:
~A guided tour at the museum
~A representative from the municipal DaneAge Association will tell about the municipality's activities for the elderly.
~The museum serves a refreshment and offer participants a season pass to the museum."
16115433|NCT02047422|Drug|Furosemide|furosemide (doubling previous furosemide dose)
16115434|NCT02047422|Drug|metolazone|metolazone (add 2.5mg qod)
16115435|NCT02047422|Drug|furosemid/spironolactone|spironolactone (doubling previous spironoalctone dose or add 12.5mg BID if previous non-user)
16115436|NCT02047422|Drug|metolazone/spironolactone|no spironolactone (maintaining previous spironolactone dose or not add spironolactone if previous non-user)
16115437|NCT02047383|Other|Respiratory infection|An assessment of the patients included in the study will be conducted
16115438|NCT02047370|Other|Diaphragm stretching|The therapist stands behind the patient and passes his hands around the thoracic cage, carefully introducing fingers under the costal margins. The patient slightly rounds the trunk in order to relax rectus abdominis. During the exhalation of the patient the therapist grasps the lower ribs and costal margin and eases the hands caudally. This traction was maintained during 5-7 minutes.
16115439|NCT02047370|Other|Placebo|The same therapist, patient position and duration of the technique, but using disconnected ultrasound
16115440|NCT02047357|Other|Learning Through Play Plus|Learning Through Play (LTP) Plus is a low-literacy, sustainable program intended to provide parents with information on the healthy growth and development of their young children. The LTP research-based activities enhance children's development while simultaneously promoting attachment security through building parents' ability to read and be sensitive to their children's cues and through active involvement in their children's development. Plus the Thinking Healthy Program (THP) which adopts 'here and now' problem-solving approach. THP uses cognitive behavior therapy (CBT) techniques of active listening, changing negative thinking, and collaboration with the family.
16115441|NCT02047344|Drug|Antroquinonol|patients will receive one 12 week cycle of antroquinonol 200 mg t.i.d. or until disease progression, unacceptable toxicity, non compliance or withdrawal of consent by the patient, or the investigator decides to discontinue treatment, whichever comes first.
16115442|NCT02047331|Procedure|periarticular injection|patients were performed bupivacaine solution to the periarticular soft tissues during surgery by the surgeon.
16115443|NCT02047331|Procedure|fascia iliaca block|patients were performed fascia iliaca block with bupivacaine solution before surgery.
16115444|NCT02047318|Drug|LUM001|Dosing of LUM001 with the objective of achieving optimal control of pruritus at a dose level that is tolerated by the participant and up to a maximum daily dose of 560 micrograms per kilogram (mcg/kg).
16115499|NCT02046993|Behavioral|Smart phone telemonitoring HBP + enhanced usual care|Smart phone telemonitoring home Blood pressure (HBP) Patients input their HBP readings to their smart phone which is sent to the data center regulary
16115445|NCT02047305|Device|Radiofrequency Ablation|Patients with a histopathological diagnosis of moderate-grade intra-epithelial neoplasia (MGIN), high-grade intra-epithelial neoplasia (HGIN) and/or early flat-type SCCA of the esophagus, are treated with radiofrequency ablation, with repeat endoscopy and follow-up treatment at 3 month intervals.
16115446|NCT02047292|Device|THA Corail PinnacleCoC28|Uncemented THA with Corail stem and Pinnacle acetabular cup with CoC 28 mm head
16115447|NCT02047292|Device|THA Corail DeltaMotion36|Uncemented THA with Corail stem and DeltaMotion acetabular cup with 36 mm head
16115448|NCT02047292|Device|THA Corail DeltaMotion40|Uncemented THA with Corail stem and DeltaMotion acetabular cup with 40 mm head
16115449|NCT02047279|Procedure|maze procedure|"The scheme of lesion pattern: box lesion + line to mitral valve + line from box to left atrial appendage. The ablation procedure was performed by using a dry bipolar radiofrequency ablation clamp. The left atrial appendage was excluded in all cases."
16115450|NCT02047279|Procedure|mitral valve surgery|For mitral regurgitation or stenosis, the procedures will be a valve repair in the majority of cases. For valves that are not amenable to repair, a valve replacement will be performed.
16115451|NCT02047279|Procedure|left atrial reduction|The enlarged left atria are plicated (suture technique) between the left and right pulmonary vein down to the inferior end of left atrial incision on the half-moon shape.
16115452|NCT02047266|Procedure|MICS CABG|Minimally invasive coronary artery bypass grafting - beating heart multi-vessel procedure in which the anastomoses are performed under direct vision through a lateral left mini-thoracotomy. The left internal thoracic artery is used to graft the left anterior descending artery or circumflex artery territories. Radial artery or saphenous vein are used (Y - grafts) to graft another myocardial territories. Right internal thoracic artery can be used as free Y-graft, as in-situ graft with radial artery (extension technique) or as in-situ graft without composite technique. Right gastroepiploic artery can be used to graft right coronary artery territory. Hybrid approach (MICS CABG + PCI), parallel transfemoral extracorporeal circulation without cardioplegia and CABG from the ascending aorta are acceptable for achievement of the complete revascularization.
16115453|NCT02047266|Procedure|OPCABG|Off-pump coronary artery bypass grafting via sternotomy (aortocoronary bypass grafting or aortic no-touch technique composite grafting). Mechanical Devices are used for coronary artery stabilization and heart positioning. Pericardial traction sutures are used to position the heart where appropriate. Blowers and Intracoronary shunts are used routinely. Anticoagulation is obtained using sodium heparin at a dose of 2mg/kg with supplemental doses to maintain adequate heparinisation (Activated clotting time>250seconds).
16115454|NCT02047266|Procedure|ONCABG|On-pump coronary artery bypass grafting via sternotomy (aortocoronary bypass grafting or aortic no-touch technique composite grafting). Normothermic cardiopulmonary bypass and complex blood ante-retrograde cardioplegia are used. All patients are cannulated with an proximal aortic cannula and two-stage right atrial cannula. Extracorporeal circulation is provided by the Terumo System-1 heart-lung machine using cardiopulmonary bypass systems with physiological surfaces and opened venous reservoirs. The left internal thoracic artery is used to graft the left anterior descending artery, and radial artery or saphenous vein segments are used to graft another myocardial territories. Anticoagulation is obtained using sodium heparin at a dose of 3mg/kg (ACT, activated clotting time>450seconds).
16115455|NCT02047266|Device|Octopus® Nuvo, Starfish® Non-Sternotomy, thoracic retractor (ThoraTrak®)|Octopus® Nuvo - MICS CABG tissue stabilizer available for minimally invasive procedures. It minimizes the motion of a small area of the heart while the rest of the heart continues to beat normally and allows to perform anastomosis through a small incision. Starfish® Non-Sternotomy (NS) - MICS CABG heart positioner available for minimally invasive procedures. It allows for the positioning of the beating heart through a small incision, bringing coronary targets into the operative thoracotomy window. ThoraTrak® - a reusable, stainless steel MICS thoracic retractor system for minimally invasive heart surgery with multiple interchangeable blades, which allows to harvest left internal thoracic artery and to perform anastomosis through a small left thoracotomy(Medtronic, Inc., Minneapolis, MN).
16115456|NCT02047266|Device|Starfish®, Octopus®, Clearview® blower, ClearView® Shunt|Starfish® - heart positioner is designed to position and to hold the heart to give the surgeon easy access to the vessel requiring the bypass graft. Octopus® - tissue stabilizer minimizes / limits the motion of a small area of the heart while the rest of the heart continues to beat normally. This allows the surgeon to perform CABG surgery without stopping of the heart and without using the heart-lung machine. ClearView® Blower is designed to improve visualization of the surgical site. An irrigation mist gently clears blood from the site, improving visualization without drying or desiccating delicate tissue. The ClearView® shunt - Intracoronary shunt provides a clear anastomotic site during the procedure while providing blood flow to the distal myocardium (Medtronic, Inc., Minneapolis, MN)
16115457|NCT02047253|Drug|Carfilzomib|Carfilzomib will be administered on days 1, 2, 8, 9, 15, 16 within each 4 week cycle.
16115458|NCT02047253|Drug|Dexamethasone|Administered prior to administration of Study drug
16115459|NCT02047253|Drug|Acyclovir|Administered orally twice daily
16115460|NCT02047227|Drug|Pergoveris®|Pergoveris (follitropin alfa and lutropin alfa) was administered subcutaneously once daily with a starting dose of 300 International Unit (IU) recombinant human follicular stimulating hormone (rhFSH)/ 150 IU recombinant human luteinizing hormone (rhLH) after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 millimeter (mm); 250 microgram (mcg) of r-hCG (Ovidrel) was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments while maintaining the 2:1 ratio of r hFSH to r-hLH in the Pergoveris group based on the subject's response per site standard clinical practice.
16115461|NCT02047227|Drug|GONAL-f®|GONAL-f (r-hFSH) was self-administered subcutaneously once daily at a starting dose of 300 IU after confirmation of down regulation up to 21 days. After follicle attained mean diameter of 17-18 mm; 250 mcg of r-hCG was administered once subcutaneously to trigger final follicular maturation as per site standard practice. The dose adjustment for r-hFSH was allowed in 75 IU increments based on the subject's response per site standard clinical practice.
16115462|NCT02047227|Drug|Recombinant human chorionic gonadotrophin (r-hCG)|On r-hCG day, 250 mcg of r-hCG was administered once subcutaneously
16115463|NCT02047214|Drug|TPI 287|TPI 287 is a microtubule inhibitor belonging to the taxane diterpenoid (taxoid) family, and specifically to the abeotaxane class. TPI 287 is an Investigational Drug.
16115620|NCT02046200|Drug|Placebo|Matched placebo
16115464|NCT02047214|Drug|Bevacizumab|Avastin (bevacizumab) is an FDA approved drug indicated for multiple cancers, including as a single agent for GBM for adult patients with progressive disease following prior therapy. Single agent effectiveness is based on improvement in objective response rate; no data is available demonstrating improvement in disease-related symptoms or survival with bevacizumab.
16115465|NCT02047201|Radiation|IMRT|IMRT treatment planning using FDG-PET/CT images after induction chemotherapy (IC).
16115466|NCT02047201|Radiation|PET/CT|Assessing tumor response using FDG-PET/CT.
16115467|NCT02047201|Drug|Docetaxel|75 mg/m2, IV (in the vein) on day 1 every 3 weeks. Number of cycles: 3.
16115468|NCT02047201|Drug|Fluorouracil|750 mg/m2 continuous infusion for 120 h IV (in the vein) every 3 weeks. Number of cycles: 3.
16115469|NCT02047201|Drug|Cisplatin|75 mg/m2, IV (in the vein) on day 1 every 3 weeks. Number of cycles: 3.
16115470|NCT02047175|Drug|Telmisartan/S-Amlodipine|Telmisartan/S-Amlodipine 40/2.5mg 2T PO, QD for 9days
16115471|NCT02047175|Drug|Rosuvastatin|Rosuvastatin 20mg 1T PO, QD for 5days
16115472|NCT02047175|Drug|Telmisartan/S-Amlodipine + Rosuvastatin|Telmisartan/S-Amlodipine 40/2.5mg 2T + Rosuvastatin 20mg 1T PO, QD for 5days
16115473|NCT02047175|Drug|Telmisartan/S-Amlodipine + Rosuvastatin|Telmisartan/S-Amlodipine 40/2.5mg 2T + Rosuvastatin 20mg 1T PO, QD for 9days
16115474|NCT02047162|Drug|Bismuth subsalicylate|
16115475|NCT02047162|Other|Placebo|Chewable tablets identical to intervention tablets, but missing the bismuth subsalicylate
16115476|NCT02047149|Drug|Zileuton (Zyflo®) Dasatinib (Sprycel®)|To determine the maximum dose of zileuton/dasatinib in subjects with CML
16115477|NCT02047149|Drug|Dosing with Zileuton/Dasatinib in CML|Three dose levels of daily zileuton will be studied in conjunction with dasatinib to define the MTD
16115478|NCT02047149|Drug|Daily dosing of Zileuton/Dasatinib|Three dose levels of daily zileuton will be studied in conjunction with dasatinib to define the MTD
16115479|NCT02047149|Drug|Daily dosing with Zileuton/Dasatinib for CML|Three dose levels of daily zileuton will be studied in conjunction with dasatinib to define the MTD
16115480|NCT02047136|Other|Treatment group (on low histamine diet)|78 subjects who come to Allergy Centre for treatment of idiopathic urticaria, with or without angioedema and pruritus (U/A/P), will be randomized into two parallel groups; treatment group (TG) will be asked to follow a histamine-restricted diet for 4 weeks and the control group (CG) will be asked to follow a well-balanced diet instructed by a dietitian for 4 weeks. A well-balanced diet for the CG subject is tailor-made by the dietitian according to subject's usual intake to ensure that the subject's energy requirement is met and all food groups are consumed.
16115481|NCT02047136|Other|Well-balanced diet|Diet tailor-made by the dietitian according to subject's usual intake to ensure that the subject's energy requirement is met and all food groups are consumed.
16115482|NCT02047123|Dietary Supplement|Raw Flaxseed|The participants were randomly single blind controlled trial distributed into three groups: (1, n =30), (2, n =32), (3, n =27). For 30 days, participants in group 1 took with 15g flaxseed mixed with yoghurt and diet,(the 15g of flaxseed that was provided in addition to the linen package spoon so all would take far it) group 2 took yoghurt and diet, and group 3 only received the diet.
16115483|NCT02047110|Drug|placebo for risankizumab|Placebo for risankizumab administered by subcutaneous (SC) injection
16115484|NCT02047110|Drug|risankizumab|Risankizumab administered by subcutaneous (SC) injection
16115485|NCT02047097|Drug|dimethyl fumarate|Provided under routine clinical care
16115486|NCT02047071|Device|Continuous positive airways pressure|Optimal Continuous positive airways pressure treatment every night plus standard care for OSA consisting of hygienic-dietary advice and lifestyle counseling.
16115487|NCT02047045|Procedure|acupuncture|Electro-acupuncture at bilateral ST25, SP14 ,and ST37. Patients will be treated once per day for 30 minutes, 5 times/week for the first 2 weeks and 3 times/week for the next 6 weeks. Each treatment cycle will include 28 sessions for continuous 8 weeks.
16115488|NCT02047045|Drug|Prucalopride|Prucalopride Succinate will be taken orally at the dose of 2mg/day in the morning before breakfast. Each treatment cycle will be given for continuous 32 weeks.
16115489|NCT02047032|Procedure|acupuncture|For BL33, the needle (75mm) will be inserted at the point upper and outside of BL33. Insert the needle with a 30-45°angle to a depth of 50-60 mm. The needle will be manipulated with an even lifting, thrusting and twisting method and the sense of soreness and distention will radiate to the perineal region or the anus. For BL35, the needle will be inserted upward and outward slightly with an even lifting, thrusting and twisting method. The sense of soreness and distention will radiate to the perineal region or the anus. The electric stimulator will be put on the two pair of points with a spare-dense wave, 10/50 Hz, 0.1-5.0 mA. The current intensity will be increased until the participant can not stand.
16115490|NCT02047032|Drug|solifenacin|Solifenacin used in this trial is produced by Astellas Pharma Europe B.V.(Country medicine accurate character No. J20090109 )
16115491|NCT02047032|Procedure|PFMT|Intensity of the PFMT exercises will conform to the guideline of National Institute for Health and Clinical Excellence (NICE).
16115492|NCT02047019|Drug|Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)|Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), 30/16 mg, tablet, orally, once daily
16115493|NCT02047019|Drug|Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)|Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), 60/16 mg, tablet, orally, once daily
16115494|NCT02047019|Drug|Candesartan Cilexetil|Candesartan Cilexetil, 16 mg, capsule, orally, once daily
16115495|NCT02047019|Drug|Candesartan matching placebo|Candesartan matching placebo, capsule, orally, once daily
16115496|NCT02047019|Drug|Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) 30/16mg matching placebo|Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) 30/16mg matching placebo, tablet, orally, once daily
16115497|NCT02047019|Drug|Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)|Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), 60/16mg matching placebo, tablet, orally, once daily
16115498|NCT02047006|Drug|Rivaroxaban 10 mg|"Measurement of AUC of rivaroxaban and effect on coagulation assays:
~Venous blood samples (8.5 ml) are collected immediately before (t=0) and at t= 0,5, 1, 2, 4, 8, 12, 24, 36 and 44 hours after administration of rivaroxaban.
~Effect of dialysis on levels of rivaroxaban:
~Venous blood samples (8.5 ml) are collected at the start of dialysis (t=0) and at t=1, 2, 3 and 4 hours."
16115500|NCT02046993|Behavioral|Enhanced usual care|Encouraged to do HBP measurement and record BP readings in paper diary
16115501|NCT02046980|Procedure|Gufoni|
16115504|NCT02046967|Procedure|Endovenous laser ablation with 940 nm bare fiber|Endovenous laser ablation with 940 nm Diode laser using a bare fiber for treating the Great Saphenous Vein.
16115505|NCT02046967|Procedure|Endovenous steam ablation with steam vein sclerosis system.|Endovenous steam ablation with steam vein sclerosis.
16115506|NCT02046941|Behavioral|Speech Production Treatment|This treatment employs a response-contingent hierarchy made up of verbal modeling/repetition, graphic cueing, integral stimulation, and articulatory placement instruction.
16115507|NCT02046928|Drug|A6|A6 is self-administered subcutaneously two times a day for 6 cycles (1 cycle = 28 days).
16115508|NCT02046915|Drug|Imnovid (pomalidomide)|
16115509|NCT02046915|Drug|Dexamethasone|
16115510|NCT02046915|Drug|Endoxan (Cyclophosphamide)|
16115511|NCT02046889|Behavioral|Bicycle Training Intervention|
16115512|NCT02046876|Other|Multimodal Physiotherapy Program|Multimodal Physiotherapy Program integrates: physical land-based therapeutic exercise, adapted swimming and health education
16115513|NCT02046863|Device|Automated Programming|Prototype DBS-Expert software will be used to guide a clinician through DBS programming.
16115514|NCT02046850|Drug|selumetinib|Volunteers will receive a single oral dose of 75 mg selumetinib on day 1 (Treatment A).
16115515|NCT02046850|Drug|rifampicin|Volunteers will receive single, daily, oral doses of 600 mg rifampicin on Days 4 to 11 (Treatment B).
16115516|NCT02046850|Drug|selumetinib|On day 12 volunteers will receive a single oral dose of 75 mg selumetinib (Treatment C).
16115517|NCT02046850|Drug|rifampicin|On day 12 volunteers will receive a single oral dose of 600 mg rifampicin. Once daily rifampicin administrations will continue through to Day 14 (Treatment C).
16115518|NCT02046837|Behavioral|Supervised 1:1 exercise|The exercise program will be delivered in a personal training (1:1) format by a certified exercise specialist.
16115519|NCT02046837|Behavioral|Supervised group exercise|The exercise program will be delivered in a group format (4-8 participants per group) by a certified exercise specialist.
16115520|NCT02046837|Behavioral|Home-based exercise|The exercise program will be executed independently by participants in a home-based setting. Home-based participants will be supported with remote health coaching and smartphone technology.
16115521|NCT02046824|Device|Xtra®, Sorin cellsaver|when at least 750 mL of wound blood is collected in the reservoir during the operation, the washing process will be started using one of the three cell savers (see above). Samples will be taken from before and after the washing process. Thereafter, the blood will be retransfused to the patient.
16115522|NCT02046824|Device|C.A.T.S.®, Fresenius cellsaver|when at least 750 mL of wound blood is collected in the reservoir during the operation, the washing process will be started using one of the three cell savers (see above). Samples will be taken from before and after the washing process. Thereafter, the blood will be retransfused to the patient.
16115523|NCT02046824|Device|CardioPAT®, Haemonetics, cellsaver|when at least 750 mL of wound blood is collected in the reservoir during the operation, the washing process will be started using one of the three cell savers (see above). Samples will be taken from before and after the washing process. Thereafter, the blood will be retransfused to the patient.
16115524|NCT02046824|Other|no use of cell saver|When less than 750 ml of wound blood is collected in the reservoir at the end of the operation, patients will be automatically allocated to the control group. The collected blood will be cast away according to daily clinical practice and recommendations of the manufacturers.
16115525|NCT02046811|Behavioral|Patient activation and education (PAE)|Text messaging and web-based tutorials for a 12-month duration (a website and smartphone interface)
16115526|NCT02046811|Behavioral|PAE plus physician activation (PAE + MD)|Text messaging and web-based tutorials for a 12-month duration (a website and smartphone interface), physician activation/educational materials about: (1) survivors' increased skin cancer risk; (2) the benefits of and the skills needed to conduct full-body skin exams; and (3) the importance of recommending routine SSE to patients
16115527|NCT02046811|Behavioral|PAE physician activation, plus teledermoscopy (PAE +MD +TD)|Text messaging and web-based tutorials for a 12-month duration (a website and smartphone interface), physician activation/educational materials about: (1) survivors' increased skin cancer risk; (2) the benefits of and the skills needed to conduct full-body skin exams; and (3) the importance of recommending routine SSE to patients, and participant receipt of a dermoscopic lens
16115528|NCT02046798|Drug|ASP3652|oral
16115529|NCT02046785|Other|0.9% saline solution|comparing values obtained before and after administration of 500 ml of 0.9% salin
16115530|NCT02046772|Drug|Bupivacaine low dose|A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural
16115531|NCT02046772|Drug|Bupivacaine standard dose|Single intradural standard dose of bupivacaine
16115532|NCT02046772|Drug|Morphine Chloride|A dose of morphine chloride added to a low dose solution of bupivacaine administered intradural
16115533|NCT02046759|Other|Pharmacist- Intervention|Patients received additional education on basic facts about asthma, role of medications, the difference between long-term control medications and quick-relief medications, as well as patient skills in the first visit then reinforcement every two weeks.. The importance of proper inhaler technique, avoidance of asthma triggers and self-monitoring of asthma were also highlighted. Visual aids, physical demonstration as well as written information resources were supplied. Asthma care plans were tailored to patient needs and preferences. Patients were informed how to detect early signs of worsening asthma, when and how to seek medical care as appropriate.
16115534|NCT02046759|Other|Routine Care|Patients received usual care delivered by physician without pharmacist intervention. Patients were prescribed asthma medication with summarized basic information on asthma and medication use. Follow-up visits were not planned on consistent basis, but rather individually according to the disease status. No asthma action plans were provided.
16115535|NCT02046746|Other|Oral Nutritional Supplement (ONS)|renal specific commercially available ONS
16115536|NCT02046733|Drug|Ipilimumab|Induction phase: i.v. 3 mg/kg, once every 3 weeks × 4 cycles, to start within 6-8 weeks (42-56 days) from start of chemotherapy cycle 4, and not more than 2 weeks (14 days) after the date of randomisation)
16115617|NCT02046226|Device|Oxygenesys(TM) Dissolved Oxygen Dressing|OxyGenesys(TM) Dissolved Oxygen Dressing
16115618|NCT02046213|Drug|E2006|Single oral 10mg dose of 100 uCi [14C]E2006
16115619|NCT02046200|Drug|Ivermectin|Ivermectin is a semi-synthetic macrocyclic lactone used worldwide as a broad-spectrum antiparasitic avermectin.
16115537|NCT02046733|Drug|Nivolumab|Induction phase: Nivolumab i.v. 1 mg/kg, once every 3 weeks × 4 cycles, to start within 6-8 weeks (42-56 days) from start of chemotherapy cycle 4, and not more than 2 weeks (14 days) after the date of randomisation) Maintenance Phase: Nivolumab 240 mg i.v once every 2 weeks for a maximum of 12 months from start of maintenance (the first dose of maintenance nivolumab will be administered 3 weeks after the last IMP doses of induction Phase).
16115538|NCT02046720|Drug|Propofol induced sedation|"Propofol was administered using a commercially available target-controlled infusion with an incorporated pharmacokinetic model developed by Schnider (Base Primea , Fresenius-Kabi, Brezins, FRANCE)12. The initial effect-site target concentration of propofol (0.5 μg/ml) was incremented by 0.5 μg/ml every 5 minutes to ensure equilibration between plasma concentration and effect site, until loss of eyelash reflex. From the beginning of infusion until LOER patients received no other agent besides propofol for the duration of the trial.
~The BIS index was compared between a young population (18 to 64 years old) and an elderly population (65 and more)"
16115539|NCT02046707|Other|initial evaluation|
16115540|NCT02046707|Other|Period of cardiac rehabilitation|
16115541|NCT02046707|Other|final evaluation|
16115542|NCT02046707|Other|Concentric and eccentric exercise sessions|
16115543|NCT02046694|Drug|Allopurinol|At week 1, patients will begin allopurinol daily (100 mg for weight >30 kg, 50 mg for weight ≤30 kg) and will restart 6-MP and methotrexate at 50 percent of the most recent dose. Patients will continue taking allopurinol in combination with 6-MP and methotrexate for the duration of the study (total of 8 weeks).
16115544|NCT02046668|Drug|spironolactone|spironolactone 25mg daily for 12 weeks
16115545|NCT02046655|Drug|Corifollitropin alfa|
16115546|NCT02046655|Drug|rFSH|
16115547|NCT02046642|Behavioral|Maternal rest in left lateral position|After initial amniotic fluid index measurements, the participating pregnant women were instructed to turn their left sides and rest in that position for 15 minutes before a second amniotic fluid index measurement
16115548|NCT02046642|Behavioral|Maternal rest in right lateral position|After initial amniotic fluid index measurements, the participating pregnant women were instructed to turn their right sides and rest in that position for 15 minutes before a second amniotic fluid index measurement
16115549|NCT02046629|Drug|Teriflunomide HMR1726|Pharmaceutical form:tablet Route of administration: oral
16115550|NCT02046629|Drug|cholestyramine|Pharmaceutical form:power Route of administration: oral
16115551|NCT02046616|Drug|Tocilizumab|Tocilizumab 162 mg will be administered subcutaneously QW.
16115552|NCT02046616|Drug|Methotrexate|Methotrexate dosing is not specified by the protocol and will be given as per standard practice. Participants must be at a stable dose that was initiated at least 4 weeks prior to baseline.
16115553|NCT02046616|Drug|Non-Biologic DMARDs|Participants will receive non-biologic DMARDs (same non-biologic DMARD that participant was receiving at time of study entry). Dosing is not specified by the protocol and will be given as per standard practice. Participants must be at a stable dose that was initiated at least 4 weeks prior to baseline.
16115554|NCT02046603|Drug|Tocilizumab|Tocilizumab 162 mg will be administered once a week by SC injection and as a single fixed dose, irrespective of body weight, for the treatment duration of 52 weeks.
16115555|NCT02046603|Drug|DMARDs|Treatment with non-biologic DMARDs, at a stable dose that was initiated at least 4 weeks prior to baseline, is permitted during the study. The study protocol does not specify any particular therapy.
16115556|NCT02046603|Drug|Oral Corticosteroids|Stable oral corticosteroids doses (≤10 mg/day prednisone or equivalent) are allowed. The study protocol does not specify any additional detail on types of oral corticosteroids.
16115557|NCT02046603|Drug|Methotrexate|Methotrexate per investigator's discretion.
16115558|NCT02046590|Drug|Propofol|
16115559|NCT02046590|Other|General anesthesia|
16115560|NCT02046577|Dietary Supplement|Vitamin D3|Cholecalciferol administration
16115561|NCT02046577|Dietary Supplement|Placebo|Placebo liquid
16115562|NCT02046564|Drug|ASC-01|
16115563|NCT02046564|Drug|Placebo|
16115564|NCT02046551|Drug|Atomoxetine|
16115565|NCT02046551|Drug|Placebo|
16115566|NCT02046538|Drug|Leucovorin|400 mg/m2 IV over two hours (or administered concurrently with oxaliplatin or irinotecan, depending on the assigned regimen)
16115567|NCT02046538|Drug|Oxaliplatin|85 mg/m2 IV over two hours
16115568|NCT02046538|Drug|5-FU|400 mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46-48 hours
16115569|NCT02046538|Drug|Irinotecan|180 mg/m2 IV over 90 minutes
16115570|NCT02046525|Biological|Autologous fecal microbiota therapy|
16115571|NCT02046525|Other|Placebo|Saline enema
16115572|NCT02046512|Dietary Supplement|Probiotic|1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis
16115573|NCT02046512|Other|Placebo|Sugar pill
16115574|NCT02046499|Drug|Oxytocin|Oxytocin will be administered intravenously as per standard protocol
16115575|NCT02046499|Drug|Oxytocin ergometrine|Oxytocin ergometrine will be administered intra-musculalry
16115576|NCT02046486|Drug|Ticagrelor 180mg whole tablets|
16115577|NCT02046486|Drug|Ticagrelor 180mg crushed and dispersed|
16115578|NCT02046473|Procedure|Volumetric Flow in TIPS|Subjects who have a TIPS (transjugular intrahepatic portal-systemic shunt) for portal hypertension will undergo a clinical 3D ultrasound to determine if the TIPS is working properly. Additional ultrasounds will be obtained during the subject's clinically ordered ultrasound(s). These measurements will be taken by using a second ultrasound probe (plastic hand held device that is rubbed along the subject's abdomen). 15 minutes will be added to your clinically ordered exams that are completed 4 times a year.
16115579|NCT02046460|Drug|Acetylsalicylic acid|Acetylsalicylic acid, 300mg o.p.d.
16115580|NCT02046460|Drug|Vitamin K antagonist|Vitamin K-antagonists, target INR 2.0-3.0
16115581|NCT02046447|Drug|Primary Cervical Dystonia (Trihexyphenidyl)|After the baseline testing these subjects will receive a dose of trihexyphenidyl 2 mg an hour prior to the second functional magnetic resonance imaging (fMRI) scan. This is to test the change in cerebral blood flow based on blood-oxygen-level dependent (BOLD) contrast during a precision gripping task after administration of trihexyphenidyl compared to change in BOLD contrast during a precision gripping task. The subjects will be done with the study after the second MRI scan has been completed.
16115621|NCT02046200|Drug|Alcohol|
16115582|NCT02046447|Other|Controls Primary Cervical Dystonia (Trihexyphenidyl)|These subjects will receive the following: 1) data about clinical movement disorder history, age, gender, height, weight, and other medical conditions; 2) clinical neurological examination; 3) tests assessing cognitive abilities including: the Montreal Cognitive Assessment, Stroop, Digit Span, and Brief Test of Attention (BTA); 4) measures of anxiety and depression: the Beck Depression Index (BDI II). Only participants aged 18+ will be given the BDI; and 5) Functional magnetic resonance imaging (fMRI) and structural MRI will be performed.
16115583|NCT02046447|Other|DYT 1 Dystonia (Healthy Control)|These subjects will receive the following: 1) data about clinical movement disorder history, age, gender, height, weight, and other medical conditions; 2) clinical neurological examination; 3) tests assessing cognitive abilities including: the Montreal Cognitive Assessment, Stroop, Digit Span, and Brief Test of Attention (BTA); 4) measures of anxiety and depression: the Beck Depression Index (BDI II). Only participants aged 18+ will be given the BDI; and 5) Functional magnetic resonance imaging (fMRI) and structural MRI will be performed.
16115584|NCT02046447|Other|DYT 1 Dystonia|These subjects will receive the following: 1) data about clinical movement disorder history, age, gender, height, weight, and other medical conditions; 2) clinical neurological examination; 3) tests assessing cognitive abilities including: the Montreal Cognitive Assessment, Stroop, Digit Span, and Brief Test of Attention (BTA); 4) measures of anxiety and depression: the Beck Depression Index (BDI II). Only participants aged 18+ will be given the BDI; and 5) Functional magnetic resonance imaging (fMRI) and structural MRI will be performed.
16115585|NCT02046434|Drug|Glycerol Phenylbutyrate|
16115586|NCT02046421|Drug|mifepristone|Given PO
16115587|NCT02046421|Drug|carboplatin|Given IV
16115588|NCT02046421|Drug|gemcitabine hydrochloride|Given IV
16115589|NCT02046421|Other|laboratory biomarker analysis|Correlative studies
16115590|NCT02046421|Other|pharmacological study|Correlative studies
16115591|NCT02046408|Other|Computer Tablet|
16115592|NCT02046395|Drug|amlodipine, hydralazine, terazosin or hydrochlorothiazide|In the washout period, the Ace Inh or ARB classes of medicine(s) that are part of the patient's antihypertensive regimen will be discontinued. The patient will be started on alternative therapy with medications that are approved by the Food and Drug Administration for treatment of high blood pressure (such as amlodipine, hydralazine, terazosin or Hydrochlorothiazide) for control of their blood pressure.
16115593|NCT02046382|Drug|IV Acetaminophen|1000mg dose of IV acetaminophen in 100mL solution every 8 hours for 48 hours. The first dose will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
16115594|NCT02046382|Drug|Placebo|100 mL of Normal Saline every 8 hours for 48 hours. The first does will be administered intraoperatively following delivery of the baby. A total of 6 doses will be given.
16115595|NCT02046369|Drug|Lurasidone|Lurasidone flexibly dosed 20-80 mg once daily
16115596|NCT02046369|Drug|Placebo|Placebo Comparator once daily
16115597|NCT02046356|Procedure|MESS-RFA|
16115598|NCT02046343|Behavioral|Health education|Group health education sessions delivered by a promotora approximately 90 minutes in length. In the PA arm, health education incorporates at least 30 minutes group exercise.
16115599|NCT02046343|Behavioral|Telephone Counseling|Brief (10 minute) telephone counseling calls delivered by promotoras using motivational interviewing techniques. The counseling calls will emphasize behavior change strategies, including self-monitoring, goal setting, reinforcement, problem solving, stimulus control, and enlisting social support.
16115600|NCT02046343|Other|Newsletter|Educational, motivational and informational newsletters tailored for each community and hand-delivered by promotoras to participant homes.
16115601|NCT02046343|Other|Environmental Change|Create a site atmosphere that promotes PA and increases the number of PA program offerings.
16115602|NCT02046330|Device|Deep Brain Stimulation Model 3387 Model 3389|Implantation of all devices will be performed at a single session. Lead implantation will take place under local anesthesia, with implanted pulse generator (IPG) implantation under general anesthesia. The stereotaxic frame will be fitted on the day of surgery, following standard stereotactic surgical procedure. The leads will be inserted so that the stimulation sites span superolateral median forebrain bundle.
16115603|NCT02046317|Drug|Femoral Nerve Block|Femoral Nerve Block for isolated femur fractures
16115604|NCT02046317|Device|Echogenic needle|The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible.
16115605|NCT02046317|Device|Standard of care needle|The control group will receive ultrasound-guided femoral nerve block using standard of care needles.
16115606|NCT02046317|Device|Ultrasound|"The experimental arm will receive ultrasound-guided femoral nerve block using echogenic needles, which are micro laser etched near the tip to reflect sound waves back to the transducer and make the tip visible.
~The control group will receive ultrasound-guided femoral nerve block using standard of care needles."
16115607|NCT02046304|Drug|Gemcitabine|Starting dose: 400 mg/m2 by vein on days 1, 8, 22, 29, 43, and 50.
16115608|NCT02046304|Radiation|Radiation Therapy|Radiation therapy dose of 50 Gy in 25 fractions at 2.0 Gy per fraction. Radiotherapy given once daily (Monday through Friday) for 5 weeks.
16115609|NCT02046291|Drug|Romiplostim|Romiplostim at the assigned dose will be administered subcutaneously (SQ) once a week for 6 weeks. The dose will be assigned at the time of subject registration. This is a dose escalation to determine the maximum tolerated dose. The doses include 4 mcg/kg/dose, 6 mcg/kg/dose, 8 mcg/kg/dose, and 10 mcg/kg/dose.
16115610|NCT02046278|Device|LifeSeal™ Kit|
16115611|NCT02046265|Behavioral|Step Up to Prevention|Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic.
16115612|NCT02046265|Behavioral|Step Up to Prevention: knowledge|Participant receives an individual computer-delivered information session and participant is offered the HPV vaccine only by their nurse practitioner in clinic.
16115613|NCT02046265|Behavioral|Step Up to Prevention:belief|Participant receives a one-on-one tailored educational session with a trained study team member and participant is offered the HPV vaccine only by their nurse practitioner in clinic.
16115614|NCT02046265|Behavioral|Offered HPV vaccine only|Participant is offered the HPV vaccine only by their nurse practitioner in clinic.
16115615|NCT02046239|Procedure|Suture Group|
16115622|NCT02046187|Dietary Supplement|Ketogenic Diet|Patients/families meet with the study dietician after surgery to discuss the ketogenic diet (KD), ask questions and plan clinic visits. Before radiation and chemotherapy begins, training takes place about the diet, meal planning and ketone/glucose monitoring. Ketosis will begin with the help of the dietitian one week before radiation begins. The patient will follow a classic 4/1 KD during chemo-radiation, followed by a modified Atkins diet during monthly chemotherapy. At the end of this period patients will follow a normal low carbohydrate diet similar to a Diabetic diet. The dietitian will follow the patient over the course of treatment. The patient will take and record ketone and glucose blood levels daily from start to end of treatment MRI scan, and meet with the dietitian weekly during radiation, at follow-up visits and on an as-needed basis.
16115623|NCT02046187|Radiation|Radiation therapy|Patients receive standard dose (60Gy/30 fractions) external beam radiation
16115624|NCT02046187|Drug|Temozolomide|patients receive standard dose (75 mg/kg/day) temozolomide by mouth daily with radiation for 6 weeks. patients will also have standard maintenance dose (150-200 mg/kg/day) for five days each month for 12 cycles following radiation course.
16115625|NCT02046174|Biological|RENCA macrobeads|
16115626|NCT02046161|Procedure|colonoscopic examination in colon cleansing room|All patients drink two liter PEG-ELS in the colon cleansing room which is a in-hospital setting for colon preparation at 8:00 AM on the day of colonoscopy.
16115627|NCT02046148|Biological|GBS trivalent vaccine|Intramuscular injection - Liquid formulation of a vaccine containing polysaccharide capsules from serotypes Ia, Ib, and III of the Group B Streptococcus and conjugated to the Corynebacterium diphtheriae CRM197 carrier protein
16115628|NCT02046148|Biological|Placebo|Intramuscular injection - Normal saline
16115629|NCT02046135|Drug|Sodium Bicarbonate|
16115630|NCT02046135|Drug|Sodium Chloride|
16115631|NCT02046122|Drug|Idarubicin|"Eligible subjects will receive induction chemotherapy with idarubicin (12 mg/m2 intravenously for 3 days) and cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5.
~Subjects who experience no remission or partial remission will receive a second course of the identical induction chemotherapy."
16115632|NCT02046122|Drug|Cytarabine|"Cytarabine (100 mg/m2 intravenously for 7 days) starting Day 1 and ending Day 7. Patients 80 years or older will only receive 2 and 5 days of idarubicin and cytarabine respectively starting Day 1 and ending Day 5.
~Subjects who achieve a complete remission (CR) will receive 2 further courses of cytarabine postremission chemotherapy (consolidation) at 1.0 g/m2 for 6 dosages followed by HLA-mismatched DLI after the second consolidation."
16115633|NCT02046122|Biological|DLI|"HLA-mismatched DLI will be administered Day 9, approximately 24-48 hours following completion of chemotherapy at a dose of 1x10^8 cluster of differentiation 3 (CD3+) cells; however, due to logistics of planning infusions with staffing, donor availability, weekends/holidays, etc., it may be necessary to postpone cell infusion up to 96 hours.
~Given the time constraints presented by the need to start induction chemotherapy as soon as possible, in some cases, it may not be logistically possible to administer cells with induction. In these cases, patients would just receive standard induction chemotherapy and cells would be administered after consolidation 1 in addition to consolidation 2
~Subjects who achieve a CR will receive 2 further courses of cytarabine postremission chemotherapy (consolidation) at 1.0 g/m2 for 6 dosages followed by HLA-mismatched DLI after the second consolidation."
16115634|NCT02046109|Procedure|Repair|
16115635|NCT02046109|Procedure|Replace|
16115636|NCT02046096|Device|Günther Tulip® Vena Cava Filter|Temporary or permanent filter placement for the prevention of pulmonary embolism
16115637|NCT02046096|Device|Cook Celect® Vena Cava Filter|Temporary or permanent filter placement for the prevention of pulmonary embolism
16115638|NCT02046083|Drug|arachid|
16115639|NCT02046070|Drug|Cyclophosphamide|Cyclophosphamide tablets
16115640|NCT02046070|Drug|Ixazomib|Ixazomib capsules
16115641|NCT02046070|Drug|Dexamethasone|Dexamethasone tablets
16115642|NCT02046057|Procedure|PNB of SLN|Percutaneous biopsy of sentinel node
16115643|NCT02046044|Drug|Digoxin|
16115644|NCT02046044|Drug|Ivabradine|
16115645|NCT02046031|Drug|Ginkgolides Meglumine Injection|25 mg, ivdrip, once.
16115646|NCT02046018|Other|ICCM delivered by VHT|VHT's deliver ICCM to children under five in their communities
16115647|NCT02046018|Other|ICCM delivered by VHT with Cell Phone|ICCM delivered to children under 5 by VHT trained in ICCM and given cell phones
16115648|NCT02046018|Other|No intervention|VHT's selected by no ICCM training given and no drugs or cell phones.
16115649|NCT02046005|Behavioral|PRE-RA|Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) is an online tool that provides education about RA, collects data about demographics and behaviors, and presents personalized RA risk information.
16115650|NCT02046005|Behavioral|PRE-RA Plus|Personalized Risk Estimator for Rheumatoid Arthritis (PRE-RA) is an online tool that provides education about RA, collects data about demographics and behaviors, and presents personalized RA risk information. In addition, participants in this arm receive education from a health educator.
16115651|NCT02046005|Behavioral|General Rheumatoid Arthritis Education|Participants will receive general information about signs and symptoms of rheumatoid arthritis.
16115652|NCT02045992|Dietary Supplement|caffeine|Five doses of 100mg of caffeine diluted in 100 ml of decaffeinated coffee. One dose every hour for five hours
16115653|NCT02045979|Drug|BI 695501|BI 695501 single s.c. injection
16115654|NCT02045979|Drug|adalimumab-EU source|adalimumab-EU source single s.c. injection
16115655|NCT02045979|Drug|adalimumab-US source|adalimumab-US source single s.c. injection.
16115656|NCT02045966|Drug|Cocktail|Cocktail = Caffeine 200 mg, Metoprolol 50 mg, Montelukast 10 mg, Flurbiprofen 50 mg, Omeprazole 40 mg, Midazolam 5 mg, Digoxin 0.25 mg, and Pravastatin 40 mg
16115657|NCT02045966|Drug|DCV 3DAA FDC|DCV 30 mg + ASV 200 mg + BMS-791325 75 mg
16115658|NCT02045966|Drug|BMS-791325|
16115659|NCT02045953|Device|VENTOLIN Mini-Spacer|VENTOLIN mini-spacer will be used to dispense the SERETIDE Evohaler and FLIXOTIDE Evohaler
16115660|NCT02045953|Device|Aerochamber Plus spacer|Aerochamber Plus spacer will be used to dispense the SERETIDE Evohaler and FLIXOTIDE Evohaler
16115749|NCT02045238|Other|Respiratory virus screening test|Immunofluorescence analysis of nasal aspirate
16115661|NCT02045940|Drug|GSK2881078|Hot melt solution within Capsule for oral single ascending doses or repeat dose administration with planned dose level and strength of 0.1, 0.3, 1.0, 2.0, 4.0, 8.0, and 10.0 mg
16115662|NCT02045940|Drug|Placebo|Hot melt solution within Capsule for oral single ascending doses or repeat doses administration.
16115663|NCT02045927|Other|sedation monitoring with RASS score|
16115664|NCT02045927|Other|sedation monitoring with BIS-Guided monitoring|
16115665|NCT02045914|Other|calcium ionophore solution|After microinjection of sperm into the oocyte, oocytes are incubated for 15 minutes in a 30 microlitre droplet of calcium ionomycin solution
16115666|NCT02045901|Drug|Diclegis|On Day 1, all participants will take 2 tablets of Diclegis at bedtime. On Days 2 to 14, participants will take 2 tablets of Diclegis at bedtime. The minimum dosage will be 2 tablets daily at bedtime, increasing, when indicated, to the maximal dosage of 4 tablets per day on Days 3 to 14.
16115667|NCT02045901|Drug|Placebo (Sugar Pill)|On Day 1, all participants will take 2 tablets of Placebo at bedtime. On Days 2 to 14, participants will take 2 tablets of Placebo at bedtime. The minimum dosage will be 2 tablets daily at bedtime, increasing, when indicated, to the maximal dosage of 4 tablets per day on Days 3 to 14.
16115668|NCT02045888|Device|ADRCs prepared by investigational Celution Device|ADRCs (low dose and high dose) to be used in investigational treatment will be prepared using the investigational Celution Device which is being investigated under IDE 15363
16115669|NCT02045888|Biological|Placebo|Placebo is visually matched solution
16115670|NCT02045875|Drug|Dulera|Dulera is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist, FDA approved and indicated for treatment of asthma in patients 12 years of age and older.
16115671|NCT02045862|Drug|Solifenacin succinate|Participants received solifenacin 5 mg orally once a day at the same time each day.
16115672|NCT02045862|Drug|Mirabegron|Participants received mirabegron 50 mg orally once a day at the same time each day.
16115673|NCT02045862|Drug|Placebo to match solifenacin|Participants received placebo to match solifenacin 5 mg orally once a day at the same time each day. This intervention was given to maintain the blind during the study.
16115674|NCT02045862|Drug|Placebo to match mirabegron|Participants received placebo to match mirabegron 50 mg orally once a day at the same time each day. This intervention was given to maintain the blind during the study.
16115675|NCT02045849|Drug|GSK2140944 capsule|Immediate release capsule containing GSK2140944 and inactive formulation excipients with a unit dose strength of 500 mg
16115676|NCT02045849|Drug|GSK2140944 tablet|Immediate release tablet containing GSK2140944 and inactive formulation excipients with a unit dose strength of 750 mg
16115677|NCT02045849|Drug|Itraconazole capsule|Capsule containing Itraconazole with a unit dose strength of 100 mg
16115678|NCT02045836|Biological|Herpes Zoster vaccine GSK 1437173A|2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
16115679|NCT02045836|Biological|Licensed pneumococcal polysaccharide conjugate vaccine (23-valent, adsorbed), Pneumovax 23™|One dose administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
16115680|NCT02045810|Drug|Levobupivacaine|
16115681|NCT02045810|Drug|Saline|
16115682|NCT02045797|Drug|GSK2140944 Lyophile|GSK2140944 Lyophile (pale yellow to grayish yellow cake) containing 750 mg of GSK2140944 (as free base) per vial for IV infusion.
16115683|NCT02045797|Drug|GSK2140944 Capsules|GSK2140944 500 mg capsules will be supplied as pink hard gelatin capsule with no external markings filled with slightly agglomerated pale yellow to grayish yellow powder.
16115684|NCT02045784|Dietary Supplement|Infant formula|To establish dose-response relationships, formula-fed infants will be randomly allocated to three 11-day cross-over periods of exclusive consumption of infant formula providing different amounts of iodine. All iodine levels are within the required iodine levels for infant formula following the regulations of the United States, the European Union, Switzerland and New Zealand.
16115685|NCT02045784|Other|Breast milk|Unlimited breast feeding
16115686|NCT02045771|Behavioral|Behavioral Activation|"Behavioral activation is a therapy, which has been shown to be quite effective in the treatment of depression (Kanter, Manos et al. 2010; Martell, Dimidjian et al. 2010). Although previous therapies have focused more on the cognitive element, behavioural activation on its own has also been significantly effective for depression treatment (Jacobson, Dobson et al. 1996). The treatment works by increasing behaviours that help a patient with depression interact with an environment and providing consequences to positively reinforce antidepressant behaviour (Martell, Dimidjian et al. 2010)."
16115687|NCT02045771|Behavioral|Support Group|In addition to usual care, the control group will be offered a support group therapy format delivered at the same place, same visit frequency and duration of program as the intervention group. This support group is intended to simulate the intervention group format to minimize risk of biased estimate of BA effectiveness by reducing the potential placebo effect which can be seen due to frequent clinic visits and having additional attention beyond usual care.
16115688|NCT02045758|Device|Fingerstick|
16115689|NCT02045758|Device|TAP20-C|
16115690|NCT02045745|Biological|"Implantation of autologous mesenchymal stem cells (CSM) expanded in vitro and administered directly into the lung suture line"|Patients at risk of prolonged postoperative air leak will be treated by local administration of autologous mesenchymal cells expanded in vitro
16115691|NCT02045732|Biological|PF-06342674 0.25 mg/kg|Bi-Weekly Subcutaneous Injections X 6
16115692|NCT02045732|Biological|Placebo|Bi-Weekly Subcutaneous Injections X 6
16115693|NCT02045732|Biological|PF-06342674 1.5 mg/kg|Bi-Weekly Subcutaneous Injections X 6
16115694|NCT02045732|Biological|PF-06342674 6.0 mg/kg|Bi-Weekly Subcutaneous Injections X 6
16115695|NCT02045719|Drug|uncaria tomentosa (cat´s claw)|
16115696|NCT02045706|Other|Community Health Worker Trainings|
16115697|NCT02045693|Drug|Methadone|
16115698|NCT02045693|Drug|DCV 3DAA FDC|
16115699|NCT02045693|Drug|BMS-791325|
16115700|NCT02045693|Drug|Buprenorphine|
16115701|NCT02045693|Drug|Naloxone|
16115836|NCT02044458|Device|Stylette|use of stylette for successful insertion of foley catheter for induction of labor
16115837|NCT02044445|Procedure|Oocyte retrieval will be performed 36 h or 38 h after hCG administration|Oocyte retrieval will be performed 36 h or 38 h after hCG administration
16115838|NCT02044432|Other|ginger compress|Kidney ginger compress
16115702|NCT02045667|Drug|Mexiletine|"Mexiletine is a lidocaine-derivate and belongs to the class of 1B antiarrhythmic agents (Vaughan-Williams Classification of Antiarrhytmica). Class I antiarrhythmics have membrane-stabilizing properties. Drugs in this class work by interfering with the fast influx of sodium by inhibition of sodium ionchannels during the fast depolarization phase, thereby decreasing the maximal voltage and upshoot phase of the action potential.
~Mexiletine study-medication will be purchased from Stabilimento Chimico Farmaceutico Militare, Firenze, Italy."
16115703|NCT02045667|Drug|Placebo|Placebo tablets do not contain any active medicinal component.
16115704|NCT02045641|Procedure|pleuracentesis|Direct needle drainage of pleural effusions with dynamic ultrasound technique
16115705|NCT02045628|Behavioral|Investment intervention|Those in the investment group will complete carefully framed questions designed to raise the salience of the investment they have made in their procedure at baseline and 3 months follow up. The content of this intervention will be tailored to the recent experiences of the patient (ie pre or post surgery).
16115706|NCT02045615|Procedure|Proposed technique for removal of the Wichita Fusion Nail|
16115707|NCT02045602|Genetic|VCN-01|Genetically modified human adenovirus encoding human PH20 hyaluronidase
16115708|NCT02045602|Drug|Gemcitabine|1000 mg/m2 intravenous administration
16115709|NCT02045602|Drug|Abraxane®|125 mg/m2 intravenous administration
16115710|NCT02045589|Genetic|VCN-01|Genetically modified human adenovirus encoding human PH20 hyaluronidase
16115711|NCT02045589|Drug|Gemcitabine|1000 mg/m2 intravenous administration
16115712|NCT02045589|Drug|Abraxane®|125 mg/m2 intravenous administration
16115713|NCT02045576|Device|sleep position trainer|
16115714|NCT02045576|Device|Oral Appliance Therapy|
16115715|NCT02045563|Other|prise de sang|
16115716|NCT02045563|Other|magnetic resonance imaging and magnetic resonance spectroscopy|
16115717|NCT02045550|Drug|Prospan Syrup|2.5 ml twice daily for 4 weeks
16115718|NCT02045524|Other|Deep muscle injection|
16115719|NCT02045524|Other|Sub-Q Injection|
16115720|NCT02045511|Behavioral|Baltimore HEARS|Tailored aural rehabilitation for participant and communication partner
16115721|NCT02045511|Device|Baltimore HEARS|Tailored fitting and programming of a personal sound amplifier. This will be accompanied by a component of aural rehabilitation.
16115722|NCT02045498|Device|capnography feedback|capnography feedback was used for management of the resuscitation and quality of cpr performance in rescuers and outcomes of the patients was measured.
16115723|NCT02045472|Drug|VIS410|
16115724|NCT02045472|Drug|Placebo|
16115725|NCT02045459|Behavioral|Exercise Program|Subject will be exercising on a treadmill 3x/week. Subjects progress will dictate increases/decreases in time of exercise and pace.
16115726|NCT02045446|Radiation|Stereotactic Body Radiation Therapy|
16115727|NCT02045446|Drug|Maintenance chemotherapy|Maintenance chemotherapy
16115728|NCT02045433|Radiation|SABR Boost Therapy|"Initial Pelvic (+/- Para-aortic) fractionated external beam Radiation with 45 Gy to combined PTV with a boost to 55Gy for PET positive/CT enlarged nodes;
~Image Guided Hypofractionated Radiation Treatment boost to Cervix High risk CTV/PTV 28GY/4 fx.
~Patients will receive 4 fractions of 7 Gy each via stereotactic body radiation as boost therapy to a volume that encompasses the cervical tumor. A minimum of 40 hours should separate each treatment."
16115729|NCT02045394|Other|Chest X-ray|
16115730|NCT02045394|Other|computed tomography of the chest|
16115731|NCT02045394|Procedure|Bronchoscopy|In patients with haemoptysis bronchoscopy will be performed with flexible bronchoscope. A systemic research of bleeding site and causes will be done. Microbiological or pathological sampling will be executed if clinically required. In selected patients, bronchoscopy might be performed with the rigid instrument or the flexible bronchoscope in intubated patients.
16115732|NCT02045381|Procedure|MRI Group|A single research MRI
16115733|NCT02045368|Drug|IGF-Methotrexate conjugate|IV infusion at the assigned dose administered on days 1, 8, and 15 of a 28 day (4 week) cycle. Up to 7 dose levels will be tested, starting with 0.05 microequivalents per kg and up to 2.5 microequivalents per kg.
16115734|NCT02045355|Other|Fish intervention|The intervention will compare fish intake with a correspondent amount of meat. The basis for the comparison will be the estimated protein intake from fish and meat and should be almost similar both from fish and from meat. To ensure compliance and to add more variety to the diet, different fish types will be included in the intervention group and different meat sources in the control group. The types of fish (and that of meat in the control diet) that will be used will be accurately documented and will be similar for all participants included.
16115735|NCT02045342|Other|Carbohydrate drink|Ingest 500ml (1g/kg) prior to metabolic measures.
16115736|NCT02045342|Other|Placebo|Ingest 500ml of placebo prior to metabolic measures.
16115737|NCT02045303|Device|Contact Ultrasound Therapy|Following our protocol, the ultrasound wound therapy will start with contact ultrasound until it meets criteria to switch to noncontact ultrasound therapy.
16115738|NCT02045303|Device|Noncontact Ultrasound Therapy|Transition from contact to noncontact ultrasound when criteria for transition is met per our protocol.
16115739|NCT02045290|Drug|Metformin|The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in the morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.
16115740|NCT02045290|Drug|Placebo|
16115741|NCT02045277|Drug|IDP-118 Lotion|Lotion
16115742|NCT02045277|Drug|IDP-118 Monad HP Lotion|Active Comparator
16115743|NCT02045277|Drug|IDP-118 Monad Taz Lotion|Active Comparator
16115744|NCT02045277|Drug|IDP-118 Vehicle Lotion|Vehicle
16115745|NCT02045264|Drug|Icatibant (30 mg)|On Day 1, subjects will receive a single 30mg subcutaneous injection of icatibant in their abdominal area. Subjects will be discharged from the study on Day 3 after collection of study related assessments
16115746|NCT02045251|Drug|Pylera based reduced regimen|Patients with H. pylori infection will be treated with a 10 day course of reduced Pylera based regimen.
16115747|NCT02045238|Drug|Hypertonic Saline|Sodium Chloride 3% solution, previously prepared in 5 mL syringes.
16115748|NCT02045238|Radiation|Chest X-Ray|
16115839|NCT02044419|Drug|lomitapide|
16115750|NCT02045225|Behavioral|Reduction of social anxiety & substance use in gay/bi men|The study will provide Phase I trial data for a novel and innovative HIV prevention intervention for MSM built upon empirically supported interventions to reduce HIV risk among MSM and cognitive-behavioural therapy to reduce social anxiety. This study will test a novel integrated HIV prevention intervention that combines empirically supported treatments for social anxiety with HIV risk reduction counseling to reduce HIV sexual risk behaviour. Study objectives: 1) to provide data on the acceptability/feasibility of the intervention, 2) to provide data to test the intervention, and 3) to provide data that will allow for a RCT that will test intervention efficacy relative to HIV prevention interventions that do not reduce social anxiety or substance use in sexual situations.
16115751|NCT02045212|Drug|RPh201|SC injection twice a week during 13/26 weeks
16115752|NCT02045212|Drug|Placebo|SC injection twice a week during 13/26 weeks
16115753|NCT02045199|Device|Tested product : V0111 cream|Application twice a day during 28 days
16115754|NCT02045199|Device|Placebo|Application twice a day during 28 days
16115755|NCT02045186|Other|Assessment of Oral HPV Infection|"Saliva and exfoliated oral epithelial cells will be collected with collection supplies provided by OralDNA Labs. Patients will swish and gargle a saline solution for 30 seconds and expectorate it into a funneled collection tube. The collected specimen will be sent to OralDNA Labs. Three diagnostic tests will be performed on each sample to assess oral HPV infection:
~Polymerase chain reaction (PCR) for HPV DNA.
~Fluorescent in-situ hybridization (FISH).
~Viral expression: The test is based on the measurement of the viral RNA levels by methods of detection of the fluorochrome labeled HPV probes by flow cytometry."
16115756|NCT02045173|Other|Apneascan TM|Autoscoring algorithms with automatical detection of sleep apnea by the Apneascan TM
16115757|NCT02045173|Device|Polysomnography/polygraphy|1 night polysomnography/polygraphy
16115758|NCT02045147|Behavioral|Grp 1 Low Cognition, Low Activation|"The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The teach back method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation."
16115759|NCT02045147|Behavioral|Grp 2 Low Cognition, High Activation|"The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided at a 5th grade reading level. The teach back method is used to validate knowledge, skills and confidence. Once knowledge is validated, the interventions focused on motivation and handling stressful situations."
16115760|NCT02045147|Behavioral|Grp 3 Normal Cognition, Low Activation|"The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Education is provided for areas of misunderstanding. The teach back method is used to validate knowledge, skills and confidence. Interventions are focused on motivation and developing personal behavioral goals."
16115761|NCT02045147|Behavioral|Grp 4 Normal Cognition, High Activation|The intervention is focused on knowledge, skills, confidence and creating a partnership with the health care provider. Focus is on maintaining behaviors during hardship and stress. Empowering, motivating and validating are strategies utilized.
16115762|NCT02045134|Dietary Supplement|Placebo|Soluble corn flour not rich in anthocyanins
16115763|NCT02045134|Dietary Supplement|High-anthocyanin rich corn flour|Soluble corn flour at high content in anthocyanins
16115764|NCT02045121|Device|Indwelling Pleural Catheter|
16115765|NCT02045121|Procedure|Talc Pleurodesis|
16115766|NCT02045108|Behavioral|Active Retraining|
16115767|NCT02045108|Device|Sham TDCS|
16115768|NCT02045108|Device|Active TDCS|
16115769|NCT02045108|Behavioral|Sham Retraining|
16115770|NCT02045095|Drug|MLN7243|"Dose escalation stage Schedule A: Intravenous infusion on Days 1, 4, 8, 11 for a 21-day treatment cycle.
~Schedule B: Intravenous infusion on Days 1, 8, 15 for a 28-day treatment cycle.
~Dose expansion stage: MLN7243 will be administered following schedule A (twice-weekly, 21-day dosing) and/or B (once-weekly, 28-day dosing)."
16115771|NCT02045082|Procedure|Corneal sampling|Slit lamp corneal sampling with a Swab
16115772|NCT02045069|Drug|2 days Ivermectin|200-400 µg/kg once daily for 2 days and placebo once daily at D3
16115773|NCT02045069|Drug|3 days Ivermectin|200 -400 µg/kg once daily for 3 days
16115774|NCT02045069|Drug|Placebo|Placebo once daily for 3 days
16115775|NCT02045056|Drug|Gemfibrozil|
16115776|NCT02045056|Drug|Placebo|
16115777|NCT02045030|Drug|aflibercept + FOLFIRI|Aflibercept (Sanofi and Regeneron) targets the Vascular endothelial growth factor (VEGF) pathway that is a composite decoy receptor based on VEGFR-1 and VEGFR-2 fused to an Fc segment of IgG1. In pre-clinical assessments, aflibercept results in stronger angiogenesis inhibition than bevacizumab, exhibiting at least 100-1000 times higher affinity to the circulating VEGFs. It is postulated that in vivo, the binding of these ligands to aflibercept results in the blockade of tumor angiogenesis along with pruning of existing tumor vascular elements and reduction of VEGF-driven vascular permeability. The expected outcome is reduced growth of primary and metastatic tumors by impeding the density of tumor vasculature and diminishing the abnormal leakiness of tumor vessels that supply matrix components to the cancer.
16115778|NCT02045017|Drug|Pomalidomide and Dexamethasone|
16115779|NCT02044991|Drug|Corticosteroid|40mg of a non-fluorinated injectable glucocorticoid, methylprednisolone acetate (1cc) combined with 1cc of 1% Lidocaine
16115780|NCT02044991|Drug|Placebo Injection|A placebo injection
16115781|NCT02044978|Device|Zoledronate-coated dental implant|
16115782|NCT02044965|Other|Antibiotic|2 mg/kg per day via oral ingestion.
16115783|NCT02044965|Drug|Probiotic|2 capsules; 5 billion total organisms of L. rhamnosus GR-1 and L. reuteri RC-14 per capsule
16115784|NCT02044952|Drug|Mesalazine, Tripterygium glycosides|tripterygium glycosides: 2mg/kg/d, oral Mesalazine: 4g/d, oral
16115785|NCT02044939|Other|Pulmonary rehabilitation program|Pulmonary rehabilitation program should follow ATS/ERS Guidelines (2006)
16115786|NCT02044913|Behavioral|Phone-based Aftercare-Coordination|After inpatient treatment patients receive six phone contacts of aftercare-coordination at intervals of two weeks carried out by therapists for 12 weeks. The intervention is case-management orientated and aims at supporting the patients in finding and organising an adequate aftercare treatment.
16115840|NCT02044406|Drug|BI 1181181|single dose (low to high dose)
16115841|NCT02044406|Drug|BI 1181181, R|powder for oral solution
16115787|NCT02044887|Other|physical activity|The characteristics of the PCD and CF and motivation will be evaluated to increase the AF through the (Test Prochaska-Diclemente). For 3 months will receive instructions to perform AF autonomously (walking, preferably in the vicinity of the place of residence). The intervention will be conducted by a professional of the health center so only couples of the intervention group will have knowledge of the specific recommendations of the AFISDEMYF. It is an intervention that has demonstrated its effectiveness in the PEPAF study (large, Sanchez et al. 2009) adapted, designed and implemented by primary care professionals for patients with dementia and for family members who care for them.
16115788|NCT02044874|Drug|APD356-lorcaserin hydrochloride|
16115789|NCT02044874|Drug|Placebo|
16115790|NCT02044861|Drug|PFK-158|IV dose escalation
16115791|NCT02044848|Drug|Secukinumab|
16115792|NCT02044848|Drug|Placebo|Placebo
16115793|NCT02044835|Drug|Fu-zheng-qu-zhuo oral liquid|Fu-zheng-qu-zhuo oral liquid was composed of Ginseng, Astragalus, Angelica root, Tuckahoe, Rhubarb, etc. It was producted by manufacturing laboratory of Guang'anmen Hospital, China Academy of Chinese Medical Science (License code: 京药制字Z20063242)
16115794|NCT02044822|Drug|Idelalisib|150 mg tablets administered orally twice daily
16115795|NCT02044822|Drug|Rituximab|375 mg/m^2 administered intravenously once weekly x 8 weeks
16115796|NCT02044809|Drug|Cannabidiol|
16115797|NCT02044809|Drug|Placebo|
16115798|NCT02044796|Drug|Cladribine|Given IV
16115799|NCT02044796|Drug|Cytarabine|Given IV
16115800|NCT02044796|Biological|Filgrastim|Given SC
16115801|NCT02044796|Other|Laboratory Biomarker Analysis|Correlative studies
16115802|NCT02044796|Drug|Mitoxantrone Hydrochloride|Given IV
16115803|NCT02044783|Behavioral|Behavioral Counseling|
16115804|NCT02044757|Behavioral|SSB withdrawal|During days 1-5, participants will drink the beverages they normally consume (no intervention). On days 6-8, participants will be instructed to drink only water and unflavored milk during the withdrawal period (days 6-8).
16115805|NCT02044744|Behavioral|Physical activity referral|Provision of a primary care referral to at least one community-based physical activity program that is a good match for the participant's needs and preferences and patient follow-up on enrollment.
16115806|NCT02044731|Behavioral|Active and Healthy Families|A pediatric overweight/obesity intervention delivered through five bi-weekly family-based group sessions.
16115807|NCT02044705|Behavioral|Active and Healthy Families|Pediatric obesity intervention delivered through five bi-weekly Active and Healthy Families family-based group medical appointments (i.e., sessions).
16115808|NCT02044679|Other|Water|
16115809|NCT02044679|Other|No intervention|
16115810|NCT02044666|Device|Micronized Small Intestinal Submucosa (SIS)|Micronized Small Intestinal Submucosa (SIS)
16115811|NCT02044653|Drug|GX-E2|Each Group of Peritoneal dialysis patients (n=10) will be administered GX-E2 3ug/kg to 8ug/kg
16115812|NCT02044653|Drug|GX-E2|Each Group of Peritoneal dialysis patients (n=24) will be administered GX-E2 5ug/kg to 8ug/kg
16115813|NCT02044653|Drug|GX-E2|Each Group of Hemodialysis patients (n=30) will be administered GX-E2 5ug/kg to 8ug/kg
16115814|NCT02044653|Drug|NESP|Each Group of Hemodialysis (n=30) will be administered NESP 30ug
16115815|NCT02044653|Drug|MIRCERA|Each Group of Peritoneal dialysis (n=24) will be administered MIRCERA 0.6ug/kg
16115816|NCT02044640|Procedure|Appendectomy|
16115817|NCT02044627|Drug|[14C-ETC-1002]|
16115818|NCT02044614|Other|Adjuvant Peritoneal Dialysis in the context of ongoing Hemodialysis|
16115819|NCT02044601|Drug|Onartuzumab|"Phase I: Starting dose of Onartuzumab 10 mg/kg by vein on Day 1 of each 3 week cycle.
~Phase II: Maximum tolerated dose from Phase I."
16115820|NCT02044601|Drug|Erlotinib|Phase I and II: 150 mg by mouth every day throughout radiation, except for chemotherapy day.
16115821|NCT02044601|Drug|Paclitaxel|Phase I and II: 45 mg/m2 by vein once a week throughout radiation for 7 weeks.
16115822|NCT02044601|Drug|Carboplatin|Phase I and II: AUC 2 by vein once a week throughout radiation for 7 weeks.
16115823|NCT02044601|Radiation|Radiation Therapy|Phase I and II: Radiation therapy at 66 Gy in 33 fractions delivered 5 days a week for 7 weeks, or proton therapy delivered at biological equivalent to 66 Gy (RBE) (RBE = 1.1) in 33 fractions 5 days a week for 7 weeks.
16115824|NCT02044588|Biological|HBsAg positive kidney allograft donor|
16115825|NCT02044562|Dietary Supplement|nitrate supplementation|A 70 ml beetroot juice containing 0.45g nitrate will be provided to the patients for 7 days at the end of the radiotherapy.
16115826|NCT02044562|Dietary Supplement|Placebo|A 70 ml placebo containing 0 g nitrate will be provided to the patients for 7 days at the end of the radiotherapy.
16115827|NCT02044549|Drug|carbetocin|Oxycontin analogue
16115828|NCT02044549|Drug|Syntometrine|Uterotonins
16115829|NCT02044536|Other|No intervention|retrospective data review
16115830|NCT02044523|Device|Transient elastography, acoustic radiation force impulse, magnetic resonance elastography|Transient elastography (Fibroscan) Acoustic Radiation Force Impulse (ARFI) Magnetic Resonance Elastography (MRE)
16115831|NCT02044510|Drug|Mirabegron|Mirabegron 25mg PO daily for 2 weeks, with dose increase to Mirabegron 50mg PO daily for the remaining 8 weeks.
16115832|NCT02044510|Drug|Placebo|Matched placebo capsules to the intervention arm
16115833|NCT02044497|Drug|oral oxycodone|
16115834|NCT02044484|Behavioral|Multi-component intervention|"The computer-based intervention (CBI) is offered to patients whose viral load exceeds 1000 copies/mL at enrollment.
~Counseling is offered to patients whose viral load does not drop 1-log after the first CBI or remains above 200 copies/mL after completing two CBIs.
~The behavioral screener will be conducted of all patients at primary care visits. The patient completes the screener before seeing the provider. Responses are given to their provider who can use it in clinical care of the patient.
~At primary care visits, all patients are given a palm card containing 1 of 15 empowering messages before they leave the clinic. Messages cover three domains: adhering to antiretroviral therapy, regular care, and safer sex."
16115835|NCT02044471|Other|Remote Ischemic Conditioning (using Sphygmomanometer)|"Patients in experimental arm will have validated protocol of Remote Ischemic Conditioning (using Sphygmomanometer): 5 minutes with blood pressure cuff inflated at 200 mmHg, then deflated for 5 minutes; repeated for 3 cycles.
~Patient in control group will not perform this."
16115842|NCT02044406|Drug|BI 1181181, T2|tablet, fasted
16115843|NCT02044406|Drug|Placebo to BI 1181181|Placebo to BI 1181181
16115844|NCT02044406|Drug|BI 1181181, T1|tablet, fed
16115845|NCT02044393|Drug|itraconazole|multiple doses of itraconazole given as capsules
16115846|NCT02044393|Drug|BI 691751|single dose BI 691751 given as tablet
16115847|NCT02044393|Drug|BI 691751|single dose BI 691751 given as tablet
16115848|NCT02044380|Drug|Afatinib|40, 30, or 20mg tablets taken once daily, dosage depending on tolerability
16115849|NCT02044367|Drug|Dabigatran etexilate|Pellets (multiple dose of dabigatran)
16115850|NCT02044367|Drug|Dabigatran etexilate|Granules resolved in reconstitution solution (multiple dose of dabigatran)
16115851|NCT02044367|Drug|Dabigatran etexilate|Hard capsule (multiple dose of dabigatran)
16115852|NCT02044354|Drug|Taxotere|
16115853|NCT02044354|Drug|Jevtana|
16115854|NCT02044341|Drug|AR01|drops administered an needed for pain
16115855|NCT02044341|Drug|Glycerin ear drops|placebo drops administered for ear pain
16115856|NCT02044328|Drug|Icotinib|Icotinib is administered 125 mg three times per day.
16115857|NCT02044315|Device|ICD programming|
16115858|NCT02044302|Drug|Bupivacaine|
16115859|NCT02044302|Drug|Botulinum Toxins|
16115860|NCT02044302|Drug|Analgesics|
16115861|NCT02044276|Drug|lipegfilgrastim|6 mg
16115862|NCT02044276|Drug|pegfilgrastim|6 mg
16115863|NCT02044263|Behavioral|Internet CBT-i SHUTi|Computer program SHUTi is based on the same theoretical model of insomnia and involves the same interventions as ordinary CBT-I: a structured treatment focusing on education, behaviors and cognitions. Specifically, CBT-I usually consists of one or more of the following: psychoeducation about sleep, sleep restriction therapy, stimulus control, relaxation techniques, and challenging beliefs and perception of sleep.
16115864|NCT02044263|Behavioral|face-to-face CBT-i|
16115865|NCT02044250|Drug|Clopidogrel|Clopidogrel 75mg 1tab P.O. daily
16115866|NCT02044250|Drug|Aspirin|Aspirin 100~200mg 1~2tab P.O. daily
16115867|NCT02044237|Behavioral|Decoupling|
16115868|NCT02044237|Behavioral|Progressive relaxation|
16115869|NCT02044224|Drug|Dexmedetomidine|"Dexmedetomidine 0.4 µg/kg/hr infusion (from the start of anaesthesia until the end of anaesthesia).
~Anaesthesia induction: propofol 2 mg/kg, rocuronium 0.6 mg/kg iv, and fentanyl 2-3 mikrogram/kg.
~Anaesthesia maintenance: sevoflurane and oxygen 50%, rocuronium 0.1-0.2 mg/kg iv, fentanyl 1 mikrogram/kg as required"
16115870|NCT02044211|Behavioral|Collaborative Care for Heart Failure|"Nurse care managers will provide patients with education for their heart failure to facilitate self-management for their condition. In addition, the nurse will telephone the patient to review with their medical history, medications, diet, activity and sleep patterns, and plans for follow-up medical appointments, and offer basic care coordination relative to heart failure care including assistance attaining authorization for home health services in concert with the patient's primary care physician (PCP), and follow-up appointments.
~After case review with a study internist, the care manager may send treatment recommendations to the patient's physician(s) regarding guideline-indicated care. Afterwards, the care manager will telephone the patient approximately every other week to monitor and promote adherence with recommended care, and suggest adjustments in treatment as applicable following discussion with the clinical team and notification of the patient's PCP and cardiologist."
16115871|NCT02044211|Behavioral|Collaborative Care for Depression|"The care manager will telephone patients randomized to blended care patient to review their psychiatric history including use of antidepressant pharmacotherapy, herbal supplements, and alcohol possibly used to self-medicate depressive symptoms; provide basic psychoeducation about depression and its impact on cardiac disease; recommend various self-management strategies (e.g., sufficient rest and exercise); and describe treatment options. They will include: (1) use of a workbook or computer program to enhance patients' understanding and ability to self-care; (2) initiation or adjustment of antidepressant pharmacotherapy prescribed under their primary care physicians' direction; or (3) referral to a local mental health specialist. The nurse will then telephone the patient to monitor symptoms and pharmacotherapy use, practice skills imparted through workbook assignments, promote adherence with recommended care, and suggest adjustments in treatment as applicable."
16115872|NCT02044198|Biological|FMP2.1/AS01B|50 µg FMP2.1 in 0.5 mL of the adjuvant AS01B (containing 50 mcg MPL + 50 mcg QS21) is administered via intramuscular (IM) injection in the deltoid region of the non-dominant arm
16115873|NCT02044185|Drug|salvage chemotherapy, total body irradiation|there are no direct interventions to our patients.
16115874|NCT02044172|Procedure|Radical prostatectomy|radical prostatectomy
16115875|NCT02044172|Radiation|Conformal radiation therapy|Conformal radiation therapy, external beam
16115876|NCT02044172|Other|Active monitoring|Active monitoring of Prostate specific antigen levels and disease surveillance
16115877|NCT02044159|Drug|Hydrocortisone|Hydrocortisone will be made up as a 10 mg/ml solution so the volume of added fluid will be very small (2 to 10 mls even for the initial dose of 2 mg/kg).
16115878|NCT02044159|Other|Placebo|The placebo (normal saline) will be identical in appearance, volume and smell to the active study drug (hydrocortisone).
16115879|NCT02044146|Drug|Ticagrelor, Prasugrel, Clopidogrel|
16115880|NCT02044133|Other|Dosage Vitamine D|
16115881|NCT02044120|Drug|niraparib|
16115882|NCT02044120|Drug|Temozolomide|
16115883|NCT02044120|Drug|Irinotecan|
16115884|NCT02044107|Behavioral|Co-packaging and counseling messages|The intervention involves co-packaging in 2 distinct packages: 1) for diarrhea treatment to package zinc & ORS for the treatment of diarrhea using a plastic bag with printed messages that were pre-tested in formative research; and 2) for pneumonia treatment to co-package zinc & antibiotics in a plastic bag with printed messages that were pre-tested in a formative research phase. Pre-tested zinc treatment messages will be on posters displayed in the intervention health centers. Orientation will be provided to health facility staff in control and intervention areas.
16115885|NCT02044094|Drug|Buprenorphine|A subcutaneous depot injection of buprenorphine 300 mg was delivered using the ATRIGEL® Delivery System on study days 1 and 29. As the depot degrades, buprenorphine is released into systemic circulation over an extended period of time.
16115947|NCT02043587|Drug|Prednisone|60 mg/m2 orally once daily on days 1-28 during Courses 1A & 2A; Maintenance: Monthly, days 1-5
16115886|NCT02044094|Drug|buprenorphine and naloxone|Buprenorphine and naloxone (SUBOXONE® sublingual film) is given to participants on days -14 to day -1 (the SUBOXONE sublingual film stabilization period) or as soon as they start to experience withdrawal symptoms. SUBOXONE sublingual film may be initially administered several times daily until a stable dose between 8 mg and 24 mg daily is established.
16115887|NCT02044094|Drug|hydromorphone|"Hydromorphone IM challenges are administered during the screening period (days -17 to -15), on days -3 to -1 during the buprenorphine and naloxone (SUBOXONE sublingual film) stabilization period, and weekly during the 12-week treatment period after administration of RBP-6000. Each challenge consists of 3 days during which participants are randomly administered 0 mg (placebo), 6 mg and 18 mg hydromorphone via intramuscular (IM) injection daily in varying blinded sequences.
~Additionally, hydromorphone can also be earned during the afternoon Reinforcing effects tasks sessions up to the same randomized dose received in the hydromorphone challenge that morning (or money can be chosen)."
16115888|NCT02044094|Drug|placebo|Placebo for hydromorphone administered via intramuscular injection during each challenge.
16115889|NCT02044081|Drug|C16G2 Rinse|Active rinses are 1.6 mg/mL C16G2.
16115890|NCT02044081|Drug|Placebo|Placebo is the vehicle without C16G2
16115891|NCT02044081|Drug|C16G2 Gel|Active C16G2 Gel is 3.2 mg/mL
16115892|NCT02044003|Device|Innovasc Tack Intravascular Staple System (Tack)|Tack-It Dissection repair
16115893|NCT02043990|Device|Noninvasive NAVA ventilation|Noninvasive NAVA Ventilation versus conventional noninvasive Pressure Support Ventilation
16115894|NCT02043977|Drug|propofol injectable emulsion|
16115895|NCT02043964|Procedure|tears and cerebrospinal fluid sampling|All patients recruited in this study will undergo a cerebrospinal fluid sampling which is an invasive procedure included in the actual routine practice. In addition a sampling from eyes will be obtain using the Schirmer test to get tears from the lacrimal gland.
16115896|NCT02043951|Device|Lutonix Drug Coated Balloon Catheter|
16115897|NCT02043938|Device|SedLine EEG sensor|Test subjects in each group will receive the same device intervention (SedLine EEG) to monitor their EEG waves.
16115898|NCT02043925|Drug|drugs linked with QT-prolongation|all the drugs that are mentioned in the lists of QT-prolonging drugs of CredibleMeds (www.crediblemeds.org)
16115899|NCT02043912|Drug|Haloperidol|
16115900|NCT02043899|Drug|[124I]meta-Iodobenzylguanidine|Single intravenous administration of [124I]mIBG Solution for Injection on Day 1 with a maximum radioactive dose of 1.42 MBq/kg (±10%) and a maximum injected dose of 50 MBq [124I]mIBG equating to a maximum chemical dose of 10 micrograms of stable mIBG. The activity to paediatric patients will be scaled by weight based upon the EANM paediatric dose card (Lassmann et al., 2007). This will result in an activity between 10 MBq and 50 MBq depending on the patient's weight.
16115901|NCT02043886|Drug|Acarbose|Acarbose 50 mg by mouth given during Meal Test
16115902|NCT02043886|Drug|Placebo|Non active substance matched to look like Acarbose 50 mg tablets. Taken by mouth during Meal Test.
16115903|NCT02043860|Radiation|Total Marrow Irradiation|Subjects in this trial will receive total body irradiation (3Gy) per day for up to four days and as little as one day. Total IMT doses: 3Gy, 6Gy, 9Gy, or 12Gy.
16115904|NCT02043860|Procedure|Autologous Transplant|Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning with escalating doses of total marrow irradiation prior to autologous stem cell rescue.
16115905|NCT02043860|Drug|Melphalan|Subjects will receive standard melphalan 200mg/m^2 (100mg/m^2 day-2 and day-1) conditioning therapy prior to transplant.
16115906|NCT02043860|Drug|Filgrastim (G-CSF)|Subjects to begin GCSF 5 μg/kg/d SC or IV on Day 5 and continue until ANC > 1000/mm^3 over period of 3 days.
16115911|NCT02043834|Other|Balance Training|"Balance training will be conducted individually two times per week for 4 weeks. Each training session will include virtual reality tasks such as ankle reaching and obstacle crossing using a virtual obstacle shown on a computer screen. Each session will last 30 - 45 minutes."
16115912|NCT02043821|Drug|Capecitabine|14days
16115913|NCT02043821|Other|placebo|14 days
16115914|NCT02043795|Device|BVS, Abbott Vascular|The aim of this study is to study the safety and clinical efficacy of a novel Bioabsorbable Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS, Abbott Vascular).
16115915|NCT02043782|Device|Coloplast Test|Newly developed 1-piece convex ostomy product
16115916|NCT02043782|Device|Own product|The subjects Own product is used as baseline performance in this investigation. The products are commercial and available on the market, and are products manufactured by manufactures who produce convex ostomy products i.e. Coloplast, Convatec, Dansac, B.Braun, Hollister and more.
16115917|NCT02043782|Device|Competitor soft convex|A commercially available soft convex product
16115918|NCT02043756|Drug|Mitoxantrone Hydrochloride Liposome|6-16mg/m2, IV ,one time of each 28 day cycle,3 cycles
16115919|NCT02043756|Drug|Mitoxantrone|10mg/m2, IV ,on day 1 of each 28 day,3 cycles
16115920|NCT02043743|Biological|Biological: Stem Cells|Biological: Stem Cells 60 ml of bone marrow will aspirated and used for stem cells isolation. Then stem cells will cultured using autologous serum, characterized and prepared using GMP rules and finally 3-5 million MSCs injected into ovarian tissue.
16115921|NCT02043730|Drug|Nab-paclitaxel and Gemcitabine|Chemotherapy will consist of nab-paclitaxel 125 mg/mq over 30 min and gemcitabine 1000 mg/mq weekly on days 1, 8 and 15 of a 28-day cycle
16115922|NCT02043730|Drug|Gemcitabine|gemcitabine 1000 mg/mq over 30 minutes on days 1, 8 and 15 of a 28-day cycle.
16115946|NCT02043587|Drug|CTX|750 mg/m2 IV, days 1 &15 for subjects <40 year of age, substitute cyclophosphamide 500 mg/m2 IV over 60 minutes every 12 hours for 4 doses on days 15 & 16 for subjects < 40 years of age if day 14 bone marrow M2 or M3; Courses 1A & 2A
16115975|NCT02043366|Drug|Butorphanol|Butorphanol is intravenously administrated
16115923|NCT02043717|Dietary Supplement|Vitamin D|"Supplementing oral cholecalciferol according to the new guidelines by:
~Tangpricha V, Kelly a, Stephenson a, Maguiness K, Enders J, Robinson K a, et al. An update on the screening, diagnosis, management, and treatment of vitamin D deficiency in individuals with cystic fibrosis: evidence-based recommendations from the Cystic Fibrosis Foundation. The Journal of clinical endocrinology and metabolism [Internet]. 2012 May [cited 2012 Oct 31];97(4):1082-93. Available from: http://www.ncbi.nlm.nih.gov/pubmed/22399505"
16115924|NCT02043704|Drug|IV Acetaminophen|Details covered in arm description.
16115925|NCT02043691|Device|Cook Custom Aortic Endograft|The Cook Custom Aortic Endograft has a variable design such that seal and fixation may be obtained proximal and distal to pathology in the juxtarenal aorta, suprarenal or thoracoabdominal aorta. Grafts may include a combination of up to 5 fenestrations and branches.
16115926|NCT02043691|Device|Zenith t-Branch Endovascular Graft|The Zenith t-Branch Endovascular Graft is a tubular graft with four branches and a covered stent at the proximal end that contains barbs for proximal fixation of the device. The graft is designed to be connected with celiac, superior mesenteric and two renal arteries via self-expanding covered bridging stents.
16115927|NCT02043691|Device|Surgeon-Modified Endograft|The Surgeon-Modified Endografts are created in the operating room by modifying a commercially-available Cook Alpha Thoracic Endograft or Cook Zenith Infrarenal Aortic Device such that seal and fixation may be obtained proximal and distal to pathology in the juxtarenal aorta, suprarenal or thoracoabdominal aorta. Grafts may include a combination of up to 5 fenestrations and branches.
16115932|NCT02043665|Biological|CVA21/pembrolizumab|
16115933|NCT02043652|Drug|Chloroquine|Patients will receive 3-day treatment with chloroquine in accordance to treatment guidelines in Brazil. All patients will receive the same treatment as there is no comparison arm.
16115934|NCT02043652|Drug|Primaquine|Patients will receive 7-day treatment with primaquine, in conjunction with chloroquine, in accordance to treatment guidelines in Brazil. All patients will receive the same treatment as there is no comparison arm.
16115935|NCT02043626|Other|DISTRICT WELLNESS COMMITTEE|Three Targeted Schools (N+PA) will expand the District's school based wellness initiative, PAW-Physical Activity and Wellness. With District support, PAW schools develop School Wellness Teams (SWTs) to identify school health priorities, implement and sustain health initiatives through school campaigns, promote healthy behavior, and support wellness policies. Results from a 3-year evaluation suggest significant and sustained positive impact on school health culture, student behavior, time-on-task, and increased physical activity among students.
16115936|NCT02043626|Other|NUTRITIONAL QUALITY OF FOODS AND BEVERAGES ON CAMPUS|Policy changes will focus on 6 target schools. District will expand nutrition education by integrating other opportunities to learn and practice healthy behaviors across disciplines. Farm-to-School programs will include school visits by farmers to teach students about agriculture, healthy foods and nutrition, coinciding with Farmer's Market Menu Days. Schools will receive four 45 minute nutrition workshops per year. Community educators will offer culturally appropriate, interactive nutrition workshops and cooking demonstrations. Cafeterias will receive youth friendly nutritional messaging, regular promotion of new menu foods, and a variety of monthly nutrition-focused activities. The goals are to: increase number of students who try new menu items regularly, increase acceptance of healthy foods, and improve nutrition literacy. Policy states schools will limit celebrations that involve food to no more than 1 per class/month: 6 schools will pilot alternatives to food for celebrations.
16115937|NCT02043626|Other|HEALTH PROMOTION AND MARKETING|SWP addresses health promotion and marketing by limiting product marketing in schools, expanding nutrition education and broadening health communication with parents. In 3 targeted schools, we expand to include Staff Wellness Promotion. Adults in schools are trusted and influential role models for students; by increasing their positive health behaviors, students may be influenced to adopt similar behaviors. The District will work with the City's Employee Wellness Program to increase school staff participation.
16115938|NCT02043626|Other|OPPORTUNITIES FOR PHYSICAL ACTIVITY|District-wide policies include mandates for daily physical activity and PE and development of policies that prohibit withholding PE for punitive reasons. To further increase physical activity, the School Wellness Policy specifies expanding programs/activities that meet need, interest, and abilities of students. Exer-gaming consoles will be provided to 6 schools and will be integrated into 5th-8th grade PE classes and after-school programs. New and innovate gym equipment will be purchased for the 6 target schools for use in gym class and after school programming. Various pedometer and interactive programs encouraging physical activity in and outside of school are planned for the 6th grade.
16115939|NCT02043613|Other|Contextually enhanced physical surroundings of exercise|"Different physical surroundings of exercise may affects the patients differently and consequently influence the effect of exercise. The exercise rooms are different from each other on parameters such as source of lighting, acoustics, materials and decorations.
~The differences with the physical surroundings of exercise is the primary intervention for this study."
16115940|NCT02043613|Other|Neuromuscular exercise|The neuromuscular exercise program is the same across the two exercise groups. Consequently, this intervention is not the primary intervention of this study. The exercise program is based on the previously reported NEMEX program designed for patients with hip or knee osteoarthritis, originally published by Ageberg et al, 2010 in BMCMusculoskeletal Disorders.
16115941|NCT02043600|Behavioral|Yoga|12-week Hatha Yoga intervention 90 minutes once a week
16115942|NCT02043600|Behavioral|Self-care|Self-care books are provided for self-directed use
16115943|NCT02043587|Drug|DNR|Daunorubicin 60 mg/m2 IV (in the vein) daily 1,2,3 Courses 1A, 2A
16115944|NCT02043587|Drug|VCR|1.4 mg/m2 IV, days 1, 8, 15, 22 (cap at 2mg for ages >50) during Courses 1A, 2A; Maintenance: Day 1 during months 2-12
16115945|NCT02043587|Drug|PEG-asp|2,000 IU/m2 IV for ages </= 50, age > 50, 1000 IU/m2 IV Day 16, Courses 1A & 2A; Day 18, Course 1B; Day 17, Course 2B; Day 16, Maintenance, Month 1
16115976|NCT02043366|Drug|Flurbiprofen axetil|Flurbiprofen axetil is intravenously administrated
16115948|NCT02043587|Drug|Liposomal AraC|25 mg intrathecal (IT), on days 1 & 15 during Courses 1A & 2A; 50 mg intrathecal on day 1 during Maintenance Months 1 through 4
16115949|NCT02043587|Drug|MTX|220 mg/m2 IV bolus over 15 minutes then 60 mg/m2/hour for 36 hours once on days 2-3 and 16-17 during Courses 1B & 2B; 20 mg/m2 orally one day per week every 7 days during Maintenance Months
16115950|NCT02043587|Drug|LCV|50 mg/m2 IV over 15-30 minutes every 6 hours for 3 doses to begin immediately after completion of methotrexate infusion, then 10 mg/m2 orally or IV over 15-30 minutes every 6 hours until methotrexate level less than 0.1 micromolar during Courses 1B & 2B
16115951|NCT02043587|Drug|AraC|2,000 mg/m2 IV, days 1-4 during Courses 1C & 2C
16115952|NCT02043587|Drug|Etoposide|500 mg/m2 IV over 3 hours once daily on days 1-4 during Courses 1C & 2C
16115953|NCT02043587|Drug|Dasatinib|140 mg orally daily if BCR/ABL positive and/or Ph+
16115954|NCT02043587|Drug|Rituximab|375 mg/m2 IV once daily on days 1 & 15 (precursor B-cell ALL only, administer per institutional protocol) during Courses 1A, 1B, 1C & 2A
16115955|NCT02043587|Drug|Hydrocortisone|Randomize patients proceeding to Course 1B to hydrocortisone versus placebo prior to PEG-asparaginase treatments in Courses 1B, 2B, 3B, and Maintenance month 1
16115956|NCT02043574|Behavioral|Treadmill Exercise|Training will be started conservatively with a goal of 15 minutes total duration at 40-50% HRR. Training target HR = %(HRmax - HRrest) + HRrest. HR max is defined as peak HR based on 2 maximal exercise tests at baseline. Individuals unable to walk continuously will exercise intermittently for several minutes as tolerated, with rest intervals, and advanced as tolerated with HR, blood pressure monitoring, and Borg Perceived Exertion to assess subjective cardiopulmonary exercise tolerance, as previously described. Treadmill training velocity will advance as tolerated by week 6 to a target intensity of 70-80% maximal HRR. Duration will similarly advance to a target of 30 minutes by week 6. Following week 6, the progressive training protocol will continue with attempts to increase velocity on a weekly basis and increase duration by 5 minutes bi-weekly to peak at 50 minutes. After week 6, the target HR goal will be 75-85% of HRR as tolerated by the subject.
16115957|NCT02043574|Behavioral|Stretching (control)|Stretch controls will be enrolled in supervised stretching program for 2 days/week for 1 hour sessions. The stretch program will focus on basic mobility skills, including balance, endurance, sit-to-stand, weight shifting, leg strength, and truncal stability-coordination. Stretching will be done in groups up to 6 participants. Exercises will be performed in standing, seated, and lying positions. A log book on the stretching exercise participation and progression will be maintained and reviewed by the instructor with the participant at each session.
16115958|NCT02043561|Other|induction of urge by rectal distension|
16115959|NCT02043548|Drug|tocilizumab|given at a dose of 8mg/kg by IV infusion every 4 weeks at 6 time points (Visits 1, 2, 3, 4, 5 and 6).
16115960|NCT02043548|Drug|placebo|given by IV infusion every 4 weeks at 6 time points (Visits 1, 2, 3, 4, 5 and 6).
16115961|NCT02043535|Device|Delivery of precise levels of carbon dioxide with the RA-MR™ Virtual Sequential Gas Delivery System.|"All participants will undergo a baseline rest Rb-82 positron emission tomography (PET) myocardial perfusion imaging scan (MPI) with low-dose computed tomography. Following this baseline study, serial Rb-82 PET MPI using a target level of carbon dioxide (CO2) (approximately 60 mmHg (± 3 mmHg)) as a stress agent will be performed. The 60 mmHg level will be repeated following a minimum 10 minute rest. A rest/stress Rb-82 PET MPI will be performed after return to normal CO2 levels (normocapnea) using persantine as the stress agent.
~Myocardial perfusion stress testing"
16115962|NCT02043535|Device|Delivery of rubidium radioisotope (Rb-82) using the automated pump/elution system|All participants will undergo a baseline rest Rb-82 positron emission tomography myocardial perfusion imaging scan (PET MPI) with low-dose CT. Following this baseline study, serial Rb-82 PET MPI using three target levels of pulmonary end-tidal carbon dioxide tension (PetCO2) (approximately 60 mmHg (± 3 mmHg)) as a stress agent will be performed. The 60 mmHg level will be repeated following a minimum 10 minute rest. A second rest Rb-82 PET MPI will be performed after return to normocapnea, followed by a pharmacologic persantine stress Rb-82 PET MPI.
16115963|NCT02043522|Drug|Radioisotope|One dose of 10 mCi (370 mBq:± 10%, calibrated to time of injection) of 123I-mIBG (AdreView) administered as a single intravenous bolus over 1 or 2 minutes, followed by a saline flush.
16115964|NCT02043509|Behavioral|MiQuit|MiQuit is an automated responsive text message support programme lasting 12 weeks which provides tailored smoking cessation support and advice to the participant's mobile phone. This support includes motivational messages, advice about preparing for a quit attempt, how to manage cravings and withdrawal, dealing with trigger situations, information about how smoking affects babies and general encouragement.
16115965|NCT02043496|Behavioral|Integrative Cognitive-Affective Therapy|Integrative Cognitive-Affective Therapy is a psychotherapy treatment for binge eating that focuses on changing behaviors, feelings, thoughts, and relationships
16115966|NCT02043496|Behavioral|CBT-Guided Self Help|CBT-Guided Self Help focuses on changing behavior patterns through the use of reading and homework assignments along with sessions with a therapist.
16115967|NCT02043457|Other|phenotyping|
16115968|NCT02043444|Radiation|FDG PET-CT|
16115969|NCT02043405|Behavioral|Weight loss and exercise training intervention|Combined weight loss and exercise training intervention
16115970|NCT02043405|Behavioral|Weight loss Only Intervention|Weight loss Only Intervention
16115971|NCT02043392|Device|Magnamosis|Single-use, sterile device enables creation of a circular compression intestinal anastomosis. Device is comprised of matched pair of self-centering rare earth magnets encased in medical grade polycarbonate. Geometry of magnets' mating surfaces applies force on inside of mated rings to produce compression necrosis of intervening intestinal walls. Lesser force on outside of mated rings produces inflammatory healing of the two co-apted intestinal walls. Internal lumen creates patency of the anastomosis to prevent intestinal obstruction during compression anastomosis creation. In 5-10 days, mated rings with necrotic tissue falls into intestinal lumen and is naturally expelled with stool, leaving a well-healed anastomosis.
16115972|NCT02043379|Drug|IVIG|Those randomized to the study arm will receive a one time dose of IVIG at 12 our post-Cardiopulmonary bypass. This is significantly early than our current standard of care.
16115973|NCT02043379|Other|Placebo|If the subject is randomized to the placebo group they will receive a volume of normal saline that is equivalent to the volume of IVIG to be administered based on their weight.
16115974|NCT02043366|Drug|Normal Saline|Normal Saline is intravenously administrated before anesthesia induction
16115977|NCT02043366|Drug|Remifentanil|Remifentanil is intravenously administrated
16115978|NCT02043366|Drug|Sufentanil|Sufentanil is intravenously administrated
16115979|NCT02043340|Drug|indocyanine green|ICG group - scaling and root planing with application of 810 nm diode laser and ICG at a concentration of 5 mg/mL. Primary parameters included estimation of decrease in percentage of viable bacteria at baseline, immediate post treatment and end of 1 week and Lactate dehydrogenase (LDH) levels at baseline and end of 1 week. Secondary parameters included site-specific measures of plaque, gingivitis, pocket depth (PD) and clinical attachment loss (CAL) at specific time intervals.
16115980|NCT02043340|Device|LASER|LASER group - scaling and root planing with application of 810 nm diode laser Primary parameters included estimation of decrease in percentage of viable bacteria at baseline, immediate post treatment and end of 1 week and Lactate dehydrogenase (LDH) levels at baseline and end of 1 week. Secondary parameters included site-specific measures of plaque, gingivitis, pocket depth (PD) and clinical attachment loss (CAL) at specific time intervals.
16115981|NCT02043340|Procedure|Scaling and Root Planing|SRP group - scaling and root planning. Primary parameters included estimation of decrease in percentage of viable bacteria at baseline, immediate post treatment and end of 1 week and Lactate dehydrogenase (LDH) levels at baseline and end of 1 week. Secondary parameters included site-specific measures of plaque, gingivitis, pocket depth (PD) and clinical attachment loss (CAL) at specific time intervals.
16115982|NCT02043314|Drug|Isoniazida|
16115983|NCT02043301|Biological|Bococizumab (PF-04950615; RN316)|Single 150 mg PF-04950615 dose administered SC to the abdomen
16115984|NCT02043301|Biological|Bococizumab (PF-04950615; RN316)|Single 150 mg PF-04950615 dose administered SC to the upper arm
16115985|NCT02043301|Biological|Bococizumab (PF-04950615; RN316)|Single 150 mg PF-04950615 dose administered SC to the thigh
16115986|NCT02043288|Drug|NC-6004|"Study group (3 week/cycle):
~NC-6004 90 mg/m2 i.v. inf. over 60 min on Day 1"
16115987|NCT02043288|Drug|Gemcitabine|"Study group (3 week/cycle):
~Gemcitabine 1000 mg/m2 i.v. inf. over 30 min on Day 1 and Day 8 (follow by administration of NC-6004)
~Control group (4 week/cycle):
~Gemcitabine 1000 mg/m2 i.v. inf. over 30 min on Day 1, Day 8 and Day 15"
16115988|NCT02043275|Other|Leg training|Lower body resistance training twice per week for one hour each time.
16115989|NCT02043275|Other|Arm training|Upper body resistance training twice per week for one hour each time.
16115990|NCT02043262|Behavioral|Reablement|The intervention deals with improving function in daily activities the person defines as important in the areas of self-care, productivity and leisure.
16115991|NCT02043262|Behavioral|Standard treatment|The control intervention is standard home-based treatment/care in Norway.
16115992|NCT02043249|Other|CORD MILKING|MILKING OF UMBILICAL CORD OF THE BABY
16115993|NCT02043236|Behavioral|Healthy bones pamphlet|written educational material
16115994|NCT02043236|Behavioral|Bone Health Care Coordinator|The Bone Health Care Coordinator reviews educational materials with participant and facilitates ordering BMD.
16115995|NCT02043236|Behavioral|Letter to GP|The letter to the General Practitioner contains information about the study, recommendations for bone health, guidelines of Osteoporosis Canada, and the identical educational material that the participant received.
16115996|NCT02043223|Dietary Supplement|Vitamin A (<3-day postpartum)|Single dose 200,000 IU vitamin A supplementation at <3-day and placebo supplementation at 6-wk postpartum.
16115997|NCT02043223|Dietary Supplement|Vitamin A (6 wk postpartum)|Placebo supplementation at <3-day and single dose 200,000 IU vitamin A supplementation at 6-wk postpartum.
16115998|NCT02043223|Dietary Supplement|Vitamin A (<3-day and 6 wk postpartum)|200,000 IU vitamin A supplementation, both at <3-day and 6-wk postpartum
16115999|NCT02043223|Dietary Supplement|Placebo|Placebo supplementation, both at <3-day and 6-wk postpartum.
16116000|NCT02043210|Behavioral|Standard Treatment as Usual|Treatment normally offered at this clinic which could include individual or group substance use counseling sessions one time per week lasting one hour each time.
16116001|NCT02043210|Behavioral|CBT4CBT plus Standard treatment as usual|Subjects work with a computerized program in Spanish that teaches skills for stopping substance use and increasing coping skills. Computerized sessions are one time per week and last about one hour per session. Plus Standard treatment as usual
16116002|NCT02043184|Behavioral|Interactive Voice Response (IVR) Reminders|Reminders tailored to the oral cancer medication(s) the patients are receiving delivered by interactive voice response system with referral to a self-management guide when symptoms exceed thresholds.
16116003|NCT02043171|Dietary Supplement|Placebo|A Placebo comparator
16116004|NCT02043171|Drug|HMB plus Vitamin D|Active comparator of HMB (3 g/d) plus Vitamin D (2,000 IU/d)
16116005|NCT02043171|Behavioral|Non-Exercise|This group will not participate in 3 times per week strength training
16116006|NCT02043171|Behavioral|Exercise|This group will participate in a supervised 3 times per week strength training program
16116007|NCT02043158|Behavioral|Questionnaire|Questionnaire completion asking questions about quality of life, mood, social support, stress, diet, lifestyle, and demographic information. Questionnaire should take about 60-90 minutes to complete.
16116008|NCT02043158|Behavioral|Interview|Interview asking questions about the amount of stress participant may be having or have had in the past. It should take about 25-30 minutes to complete the interview.
16116009|NCT02043145|Biological|botulinum toxin Type A|Botulinum toxin Type A (BOTOX®) as prescribed according to standard of care in clinical practice.
16116010|NCT02043132|Drug|Tranexamic Acid|Patients randomized to TXA receive an infusion of the standard dose of Tranexamic acid (10 mg/kg) within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution.
16116011|NCT02043132|Drug|Placebo|Patients randomized to placebo receive an infusion of 10 mg/kg of normal saline within 60 minutes prior to surgery and at wound closure. The pharmacy uses the randomization list in sequential order to determine whether that patient will receive Tranexamic acid or placebo and will provide two unlabeled IV bags (patient receives two doses) of the appropriate solution.
16116012|NCT02043119|Behavioral|Breastfeeding Clinic|
16116013|NCT02043106|Other|plantar vibration|
16116116|NCT02042222|Drug|Hydroxyurea|
16116570|NCT02038647|Drug|Paclitaxel|Paclitaxel intravenous injection
16116014|NCT02043093|Behavioral|Sources of Strength|"Sources of Strength (http://www.sourcesofstrength.com/) has three phases:
~Introduction to school and community partners. Staff advisors for the program are identified and trained.
~A standard process is used for nominating student peer leaders, who are trained through a 4-hour interactive workshop. A major focus is on increasing knowledge of 'sources of strength' and skills for increasing use of those resources for themselves and other students.
~Peer Leaders plan and conduct messaging with Adult Advisor mentoring. A school-wide messaging phase involves presentations; media campaigns through posters, public service announcements, videos."
16116015|NCT02043080|Other|Xpert MTB/RIF Tuberculosis diagnostic tool|This is s new diagnostic tool that has been approved by WHO for the diagnosis of TB in HIV-infected patients in resource limited settings
16116016|NCT02043067|Other|Comprehensive TB screening|All enrollees will receive a comprehensive TB screening regardless of symptom presentation.
16116017|NCT02043054|Drug|Liraglutide|"Liraglutide (Victoza®, Novo Nordisk) is a stable analogue of the natural hormone glucagon-like peptide-1 (GLP-1). Liraglutide is licensed for use within the United Kingdom and recommended by NICE in combination with metformin, and/or sulphonylurea and/or thiazolidinedione if the following conditions are satisfied.
~BMI ≥ 35 kg/m2 in those of European descent (with appropriate adjustment for other ethnic groups) and specific psychological or medical problems associated with high body weight, or
~BMI < 35 kg/m2, and therapy with insulin would have significant occupational implications or weight loss would benefit other significant obesity-related comorbidities."
16116018|NCT02043054|Drug|Sitagliptin|Sitagliptin (Januvia®, Merck & Co) is an enzyme-inhibiting drug used to inhibit the natural enzyme dipeptidyl peptidase-4 (DPP-4). It is an oral antihyperglycaemic agent used in the treatment of T2DM. Sitagliptin is licensed to be used either alone or in combination with other oral antihyperglycemic agents (such as metformin or a sulphonylurea) and is recommended by NICE as a second line therapy.
16116019|NCT02043041|Other|Number of DBS Spots|The number of DBS spots on the card constitutes the experimental condition.
16116020|NCT02043028|Device|Chest compression with a step stool|Participants compress the chest of a manikin with a standing posture using a step stool during 5 minutes
16116021|NCT02043028|Device|Chest compression with a kneeling stool|Participants compress the chest of a manikin with kneeling posture using a kneeling stool during 5 minutes
16116022|NCT02043015|Behavioral|Condom choices|Men will receive the condom package that includes an assortment of styles, sizes, features and colors at their baseline visit, and will be able to get more condoms for free at any time after that visit by coming to a study clinic during clinic hours, or during a scheduled study visit.
16116023|NCT02043015|Behavioral|Condom-compatible lubricant choices|Men will receive condom-compatible lubricant that will include different types of lubricant (e.g., silicone-based) and different packaging (individual sachets or flat, discreet packages) at their baseline study visit, and participants will be able to access enhanced condom-compatible lubricant at any time after that visit by coming to a study clinic during clinic hours, or during a scheduled study visit.
16116024|NCT02043015|Behavioral|Couples HIV counseling and testing (CVCT)|Participants will be invited to schedule couples voluntary HIV counseling and testing (CVCT) appointments with a clinic counselor at any point after they complete their baseline study visit.
16116025|NCT02043015|Drug|Pre-exposure prophylaxis with FTC/TDF|For men who meet eligibility criteria, PrEP with Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF) will be made available beginning one month into the study. Men who express interest and meet eligibility criteria at their baseline visit can initiate PrEP at 1 month if they test negative for HIV. For men with extenuating circumstances, whose risk profile changes, of those who become more comfortable with the PrEP intervention through enrollment in the study, PrEP will be available to initiate at the 4 month visit. Men who accept PrEP will be required to have clinic visits, in addition to the regularly scheduled study visits, one month after starting PrEP and at least every 3 months afterward to monitor blood creatinine, AST/ALT and phosphorus levels.
16116026|NCT02043015|Other|Staff and provider MSM and LGBT sensitization training|The training for clinicians will focus on specific sexual health issues for MSM, including taking sexual histories in a non-judgmental way, physical examination techniques including anal examinations, and collection of rectal swabs for STI testing. Trainings will include topics about stigma, sexual identity and coming out, anal sex, STIs, and mental health. Training on LGBT sensitization will be provided for medical providers and staff in target clinics.
16116027|NCT02043015|Behavioral|HIV Testing and Risk-reduction counseling|Risk-reduction counseling will be provided to all men at baseline and additionally at 3, 6, and 12 month visits, with an additional counseling session for men on PrEP at their initiation visit (either month 1 or 4), their 1-month follow-up visit (either month 2 or 5) and at their 9 month visit. Risk reduction counseling will be client-centered counseling, according to CDC's Fundamentals of HIV Prevention Counseling protocol.
16116028|NCT02043015|Behavioral|Linkage to care|Men will be linked to needed services including HIV care and treatment for positives identified at baseline or during the study, including antiretroviral medications, and mental health services. At the end of their baseline visit, participants will receive service referral handouts for HIV care and treatment, mental health services, and other resources, as appropriate. Men who test positive for STIs will be treated at the clinic site.
16116029|NCT02043002|Procedure|18F-FDG-PET scan|
16116030|NCT02042989|Drug|MLN9708|"Dose Escalation Phase - Starting Dose of MLN9708: 3 mg by mouth on day 1, 8 and 15.
~Dose Expansion Phase Starting Dose of MLN9708: Maximum tolerated dose from Dose Escalation Phase."
16116031|NCT02042989|Drug|Vorinostat|"Dose Escalation Phase - Starting Dose of Vorinostat: 100 mg by mouth twice a day, total of 200 mg/day Days 1 to 21.
~Dose Expansion Phase Starting Dose of Vorinostat: Maximum tolerated dose from Dose Escalation Phase."
16116032|NCT02042976|Behavioral|Mindfulness-based cognitive therapy|
16116033|NCT02042976|Behavioral|Pulmonary rehabilitation|
16116034|NCT02042950|Drug|Carfilzomib|Starting dose: 20 mg/m2 by vein on Days 1 and 2 in Cycle 1 followed by 56 mg/m^2 for each subsequent dose thereafter) on days 1 and 2, 8 and 9, 15 and 16 of a 28-day cycle (following cycle 12 carfilzomib given on days 1 and 2 and 15 and 16 only).
16116035|NCT02042937|Other|Exercise|Exercise to improve gluteus maximus recruitment
16116036|NCT02042924|Radiation|FLT PET/CT|Functional marrow imaging using the FLT PET/CT will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).
16116118|NCT02042196|Drug|Placebo|Placebo pills designed to match the dissolvable KUVAN pills
16116037|NCT02042924|Device|MRI|MRI imaging will be performed prior to preparative for HSCT and approximately 3 months post-transplant (Day 100 +/- 5 days).
16116038|NCT02042911|Drug|SyB L-0501|SyB L-0501 is administered at 100 mg/m2/day by intravenous infusion on Day 1 and Day 2 followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 cycles. Dose administration can be delayed or discontinued from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle, but dose reduction is permitted from the 3rd cycle.
16116039|NCT02042898|Other|Restrictive Transfusion Strategy|
16116040|NCT02042898|Other|Liberal transfusion strategy|
16116041|NCT02042885|Drug|OPB-111001|
16116042|NCT02042872|Drug|Zoledronic acid|At baseline, study subjects in the treatment group will receive 5 mg of zoledronic acid (Reclast: 5 mg; Novartis Pharmaceuticals Inc., East Hanover, NJ) by intravenous infusion over 30 minutes.
16116043|NCT02042859|Device|Endoscopic Bipolar RadioFrequency Probe used to remove tumors in bile duct to manage Pancreatic Cancer|
16116044|NCT02042846|Device|SportWelding Fiji Anchor|
16116045|NCT02042820|Other|In vivo confocal microscopy (IVCM)|IVCM is a sensitive tool for detecting dry eye-associated subclinical inflammation.
16116046|NCT02042807|Drug|Placebo|
16116047|NCT02042807|Drug|MCS®|
16116048|NCT02042781|Drug|PG545|PG545 will be administered once weekly, as a one hour IV infusion. Patients will be treated until they exhibit disease progression, withdraw due to poor tolerability, or the study reaches its defined end-point. This study is a dose escalation study with doses of 25 mg to 250 mg anticipated.
16116049|NCT02042755|Device|trifocal intraocular lens|Standard cataract surgery
16116050|NCT02042742|Dietary Supplement|punicalagin and hydroxytyrosol mixture|Antioxidant Supplement (punicalagin and hydroxytyrosol mixture) During one period of crossover study (I or II) volunteers consume daily of functional supplement during 8 weeks. Additionally, volunteers must follow guidelines for healthy diet and physical activity.
16116051|NCT02042742|Dietary Supplement|Control supplement (maltodextrin)|During one period of crossover study (I or II) volunteers consume daily of functional supplement during 8 weeks. Additionally, volunteers must follow guidelines for healthy diet and physical activity.
16116052|NCT02042729|Drug|E2022- Current Formula Tape|"Cohort I: E2022 current formula tape administered on a skin application site and evaluated for 10 days during the introductory skin patch test.
~Cohort II: E2022 current formula tape administered to skin application site and evaluated for 20 days."
16116053|NCT02042729|Drug|E2022- New Formula Tape|"Cohort I: E2022 new formula tape administered on a skin application site and evaluated for 10 days during the introductory skin patch test.
~Cohort II: E2022 new formula tape administered to skin application site and evaluated for 20 days."
16116054|NCT02042729|Drug|E2022 Matching Placebo- Current Formula Tape|
16116055|NCT02042729|Drug|E2022 Matching Placebo- New Formula Tape|
16116056|NCT02042716|Other|diagnosis of white matter damage in preterm infants|Added value of supersonic shear imaging in the diagnosis of white matter damage in preterm infants
16116057|NCT02042703|Device|anterior segment OCT|
16116058|NCT02042690|Procedure|Haplo-identical HSCT|Haplo-identical Protocol: myeloablative human leukocyte antigen (HLA) haploidentical stem cell transplantation (haplo-SCT) using pretransplant ATG and granulocyte colony-stimulating factor (G-CSF)-stimulated grafts (ATG+G-CSF) GVHD prevention regimen: CSA/MMF/MTX, CSA 1.25mg/kg/d, i.v administrated in two doses from day -109 until bowel function returned to normal, at which time patients receive oral CSA until 12months after HRD-HSC and then gradually tapered. Every 12h, 0.5g MMF(0.25g for children) was administrated orally from day -10 to +30 and subsequently 0.25g from days +30 to +60. MTX was administrated at a dose of 15mg/m2 on day +1 and 10mg/m2 on days +3,+6, and +11.
16116059|NCT02042690|Drug|Chemotherapy|Patients receive 6 cycles of consolidation chemotherapy after randomization, including Hyper-CVAD-B regimen-Hyper-CVAD-A regimen/Hyper-CVAD-B regimen/Hyper-CVAD-A regimen/Hyper-CVAD-B regimen/Hyper-CVAD-A regimen.Maintenance treatment includes MTX 20mg/m2/w，po，6-mercaptopurine 60 mg/m2/d，po，d1-d28，VP（VDS 4mg,d1, Prednisone 1mg/kg d1-7) every one month for 2 years.
16116060|NCT02042664|Drug|BYETTA treatment|
16116061|NCT02042664|Drug|Metformine|
16116062|NCT02042651|Device|Low intensity extracorporeal shockwave therapy|Shockwaves will be applied to the perineum a total of 6 times once per week. The energy level applied will range between 0.25 and 0.40 mJ/mm2 with a frequency of 3 Hz for a total of 3000 shockwaves per treatment session
16116063|NCT02042651|Device|Sham low intensity extracorporeal shockwave therapy|Shockwaves will be applied to the perineum a total of 6 times once per week. The shockwaves will be blocked by a medium on the handheld applicator.
16116064|NCT02042638|Drug|hCG 1500 IU three times a week|
16116065|NCT02042638|Drug|Pregnyl (hCG) ampule 1500 IU/three times a week|
16116066|NCT02042625|Procedure|Nasopharyngeal|
16116067|NCT02042612|Drug|Sedation with sevoflurane during 48-hr in ICU|
16116068|NCT02042599|Drug|Sedation with sevoflurane during 48-hr in ICU|
16116069|NCT02042586|Other|Analysis of movement before total hip replacement|
16116070|NCT02042586|Other|Analysis of movement after total hip replacement|
16116071|NCT02042573|Device|rTMS|
16116072|NCT02042573|Drug|SSRI (SEROPLEX ou ZOLOFT)|
16116073|NCT02042573|Other|Genetic samples|
16116074|NCT02042560|Other|Blood samples|
16116075|NCT02042560|Other|Spleen samples|
16116076|NCT02042547|Other|Tissue samples from the right atrium|
16116077|NCT02042547|Other|Blood samples|
16116078|NCT02042534|Drug|Rivaroxaban|"Rivaroxaban group receive oral rivaroxaban 10 mg once daily for 5 consecutive days, followed by 20 mg or 15 mg in patients with a calculated creatinine clearance of 30-49 ml/min.
~The dosage of rivaroxaban is leveraged from results of ROCKET-AF trial, where 20 mg of rivaroxaban was shown to offer balanced efficacy and safety."
16116079|NCT02042534|Drug|Warfarin|To harmonize the warfarin regimen across the sites, fixed algorithm was used in dose calculation, both loading and maintenance, and age, sex, ethnicity, race, weight, height, smoking history, presence of liver disease, indication, baseline INR, target INR and concomitant medication were considered as cofactors (http://www.warfarindosing.org/Source/InitialDose.aspx). Investigators will manage anticoagulation with warfarin per routine clinical care.
16116117|NCT02042196|Drug|KUVAN|KUVAN will be given orally at 10mg/kg dose per body weight. KUVAN will be dissolved in 4-8oz water and consumed within 15 minutes.
16116080|NCT02042521|Drug|Dietary Supplement|The active evening dietary supplement is taken at 22:00. The active morning dietary supplement is taken at 8:00-8:15. The active evening dietary supplement is taken first. The active morning and evening dietary supplements are taken within 12 hours in time points as specified above.
16116081|NCT02042521|Drug|Lactose Placebo|This research study involves a placebo dietary supplement that does not have any of or only partial of the active ingredients in the active dietary supplement. The placebo dietary supplement will be given in identical time points to match that of the active dietary supplements.
16116082|NCT02042508|Other|strengthening|
16116083|NCT02042508|Other|hybrid training programme|
16116084|NCT02042495|Drug|Metformin|
16116085|NCT02042482|Dietary Supplement|Coenzyme Q10U, L-carnitine|
16116086|NCT02042456|Device|Digital Breast Tomosynthesis|digital breast tomosynthesis technology
16116087|NCT02042456|Device|Automated Whole Breast Ultrasound|Automated Whole Breast Ultrasound
16116088|NCT02042456|Device|Full Field Digital Mammography|
16116089|NCT02042443|Drug|Capecitabine|Given PO
16116090|NCT02042443|Drug|Fluorouracil|Given IV
16116091|NCT02042443|Other|Laboratory Biomarker Analysis|Correlative studies
16116092|NCT02042443|Drug|Leucovorin Calcium|Given IV
16116093|NCT02042443|Drug|Trametinib|Given PO
16116094|NCT02042430|Drug|Epacadostat|Given PO
16116095|NCT02042430|Other|Laboratory Biomarker Analysis|Correlative studies
16116096|NCT02042430|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16116097|NCT02042417|Device|INRatio2 and CoaguChek|
16116098|NCT02042404|Device|Sound amplification provided via EarLens System.|The EarLens System has two primary components: 1) an external Behind the Ear (BTE) Sound Processing Unit, and 2) a Tympanic Membrane Transducer (TM Transducer). In this system, light is used to wirelessly transmit both signal and power from the BTE Sound Processor to the TM Transducer. The BTE is designed to be able to be removed, reprogrammed, and have the battery recharged as needed, similar to a BTE for an air conduction hearing aid. The removable TM Transducer is customized for each patient, is placed and removed by a physician in an office visit procedure, and is designed to reside in the ear in a safe and stable manner for long periods of time.
16116099|NCT02042391|Drug|Rituximab sc|All patients will receive 4 courses of rituximab on days 1, 8, 15 and 22. Rituximab will be administered as a single therapeutic agent at a standard dosage of 375 mg/m2 infused intravenously at day 1. Three subsequent single therapeutic agent applications of rituximab will be administered subcutaneously at a fixed dose of 1400 mg once a week for 3 weeks at days 8, 15 and 22.
16116100|NCT02042391|Drug|Rituximab sc consolidation|Patients considered low-risk will receive four more single therapeutic agent applications of rituximab administered subcutaneously at a fixed dose of 1400 mg once every three weeks at days 50, 71, 92 and 113.
16116101|NCT02042391|Drug|Rituximab sc combined with CHOP chemotherapy|Patients considered high-risk will receive four more applications of rituximab administered subcutaneously at a fixed dose of 1400 mg combined with CHOP chemotherapy every 3 weeks at days 50, 71, 92 and 113. CHOP chemotherapy will be administered at standard doses: cyclophosphamide 750 mg/m2, adriamycine 50 mg/m2, vincristine 1.4mg/m2 (maximum total dose: 2mg) and prednisone 100mg (at day 1 to 5 of each cycle). Cyclophosphamid, adriamycine and vincristine will be infused intravenously. Prednison will be administered orally in a single dose. At day 3-4 of each treatment cycle either a single dose of 6 mg Peg-GCSF or repetitive doses of 5 µg/kg GCSF until recovery of WBC will be applied subcutaneously, as per institutional practice.
16116102|NCT02042391|Drug|Rituximab sc combined with alternating chemotherapy with CHOP and DHAOx|Patients considered very high-risk will receive six more applications of rituximab sc at a fixed dose of 1400 mg combined with chemotherapy every 3 weeks. Chemotherapy is CHOP at days 50, 92 and 134 (cyclophosphamide IV 750 mg/m2, adriamycine IV 50 mg/m2, vincristine IV 1.4mg/m2 (maximum total dose: 2mg) and prednisone PO 100mg (at day 1 to 5 of each cycles). Chemotherapy is DHAOx at days 71, 113 and 155 (oxaliplatin (130 mg/m2, day 1) and cytarabine (ARA-C, 2x 1000 mg/m2 at day 2) dexamethasone PO (40 mg/m2, day 1)), as per institutional practice. At day 3-4 of each treatment cycle either a single dose of 6 mg Peg-GCSF or repetitive doses of 5 µg/kg GCSF until recovery of WBC will be applied subcutaneously, as per institutional practice.
16116103|NCT02042378|Drug|Rucaparib|All patients will take oral tablets twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole.
16116104|NCT02042365|Procedure|ERAS (Enhanced recovery after surgery)|
16116105|NCT02042352|Other|pH glove|
16116106|NCT02042339|Drug|Hyperbaric oxygen|The treatment will be applied in a large walk-in drive-in hyperbaric chamber. Depending on their general condition, the patients will sit in comfortable chairs or remain in their own wheelchair or bed in relaxed position. They will be accompanied by a medical attendant or by a hyperbaric physician if necessary due to their general condition. Oxygen 100% will be distributed over a tight fitting oxygen-mask connected to the overboard-dumping system. The treatment will be administered according to the so-called problem-wound schedule once a day for six consecutive weeks. On weekends and on public holidays the patients will be off therapy.
16116107|NCT02042326|Drug|Sirolimus|For patients with swallowing problems, and for children under 6 years and / or who have an inability to swallow tablets, the 1mg/ml solution form should be used.
16116108|NCT02042313|Other|continuous epidural infusion|
16116109|NCT02042313|Other|combined paravertebral infusion and single shot of TAP block|
16116110|NCT02042300|Device|XIENCE Xpedition/Alpine/Sierra|
16116111|NCT02042287|Device|Vaginal lactic acid and glycogen gel|Medical device (registration number: 10-355-717, first licensed 12.08.2010)
16116112|NCT02042287|Drug|Metronidazole|Oral antibiotic
16116113|NCT02042274|Dietary Supplement|Fish oil supplement|Participants are instructed to consume fish oil supplements on a daily basis for a 3-month period.
16116114|NCT02042248|Biological|AGS-004|All participants in both arms will receive the same treatment and doses of AGS-004 in Step 2 at weeks 0, 4, 8, and 12.
16116115|NCT02042235|Behavioral|Parent-implemented intervention|In order to achieve the programme of parent-implemented language intervention, a detailed protocol for speech therapists recruited and trained for the present study has been established. The techniques and attitudes favouring use of oral language will be taught to the parents during 15 sessions with the parent(s) and child.
16116119|NCT02042196|Drug|Cetrotide|Cetrotide (0.25mg/d) will be taken daily for 10 days via abdominal subcutaneous injection.
16116120|NCT02042196|Drug|Climara|0.075mg/d transdermal patch will be placed on skin.
16116121|NCT02042196|Drug|Placebo transdermal patch|Inactive transdermal patch
16116122|NCT02042183|Drug|Lubiprostone|12 or 24 mcg soft capsules of lubiprostone for oral administration, depending on baseline weight and response during week 1
16116123|NCT02042183|Drug|Placebo|0 mcg soft capsules of placebo for oral administration
16116124|NCT02042170|Drug|human growth hormone self-injection|
16116125|NCT02042157|Behavioral|Bidet use|Participants used a bidet, a device installed on the toilet that provides fresh water to help clean the bottom and genitalia after having a bowel movement or urinating.
16116126|NCT02042157|Other|Regular toileting|Patients in the control arm will toilet as usual.
16116127|NCT02042144|Drug|Stivarga (Regorafenib, BAY73-4506)|Patients diagnosed with mCRC who have been previously treated with, or are not considered candidates for, other locally approved standard treatment(s) and for whom the decision has been made per investigator's routine treatment practice to prescribe regorafenib
16116128|NCT02042131|Behavioral|Treatment As Usual (TAU)|
16116129|NCT02042131|Behavioral|Standard Crisis Response Plan (S-CRP)|
16116130|NCT02042131|Behavioral|Enhanced Crisis Response Plan (E-CRP)|
16116131|NCT02042118|Device|Laryngeal Mask Airway|Laryngeal mask airway (LMA) ventilation will be provided for newborns in this arm during the first 2.5 minutes.
16116132|NCT02042118|Device|Face mask ventilation|Face-mask ventilation (FMV) will be provided for newborns in this arm during the first 2.5 minutes.
16116133|NCT02042092|Device|Ultrasound|
16116134|NCT02042092|Device|MRA|
16116135|NCT02042079|Procedure|EFTR with LA|(Endoscopic full-thickness resection with laparoscopic assistance)
16116136|NCT02042066|Device|Omnispec model Vascuspec|Energy Density: 0.09 - 0.1 mJ/mm2 Extracorporeal Shockwave Therapy
16116137|NCT02042053|Device|PET/CT|
16116138|NCT02042053|Device|PET/MRI|
16116139|NCT02042027|Drug|Gamunex-C|Patients will receive 50 mg (0.5 mL) subconjunctival Gamunex-C injection in addition to standard of care treatment (steroids and cyclosporine)
16116140|NCT02042014|Drug|QTI571|QTI571 200mg up to 400mg (depending on tolerability) taken orally, once a day.
16116141|NCT02042001|Drug|Immediate switch to TDF/FTC/RPV|
16116142|NCT02042001|Drug|Switch to TDF/FTC/RPV after 24 weeks|Patients will continue current EFV-containing regimen up to week 24 and then will be switched to TDF/FTC/RPV
16116143|NCT02041975|Dietary Supplement|Nutriose FB06|Wheat dextrin soluble fibre
16116144|NCT02041975|Dietary Supplement|Placebo|
16116145|NCT02041962|Behavioral|Chronic Care Model for Mood Disorders|"The mood disorders CCM intervention (Life Goals Collaborative Care) consists of: (a) a web-based patient self-management skills enhancement (CCM-1), (b) enhanced information flow and continuity of care via a care manager (CCM-2), and (c) decision support, or situation-specific evidence-based clinical practice guideline recommendations for providers (CCM-3). The CCM will be implemented utilizing telephonic contact with patients and providers by an Aetna care managers.The care managers will also use the Life Goals web portal as a guide for each session."
16116146|NCT02041962|Other|Educational Control|
16116147|NCT02041936|Device|NanoKnife IRE System|
16116148|NCT02041923|Behavioral|H-HOPE|Infant remediation using a developmentally appropriate multisensory intervention addresses the specific behavioral organization needs of premature infants. Maternal redefinition and re-education by a nurse-community advocate team uses participatory guidance to address the needs of mothers of premature infants.
16116149|NCT02041923|Other|Attention Control|Mothers received equal amount of attention from the team. Attention consisted of additional teaching regarding premature infant care.
16116150|NCT02041910|Biological|Stem Cells|MSCs injection intratesticular
16116151|NCT02041910|Biological|Stem Cells|60 ml of Bone marrow will aspirated for stem cells isolation and preparation. 5 ml of stem cells prepared according to GMP rules injected into testis.
16116152|NCT02041897|Procedure|EUS-FNA|Only one puncture will be performed. First the fluid will be aspirated out for biochemical analysis and cytology. Then the tissue will be aspirated out from the solid part of the lesion for pathology.
16116153|NCT02041884|Behavioral|iCBT for Adults with ADHD|A skill training internet-based treatment program based on CBT and DBT interventions .
16116154|NCT02041884|Behavioral|Internet stress-reduction|Internet-based psychoeducation, stress-reduction, and Applied Relaxation based on CBT (control group)
16116155|NCT02041884|Other|Treatment as usual (TAU)/waiting list|Treatment as usual (usually medications for ADHD), will be offered treatment after the FU3 (week 24)
16116156|NCT02041871|Dietary Supplement|Oral immunonutrition|Powder 74g within 250ml of water, 3 times per day during 7 days before surgery
16116157|NCT02041871|Dietary Supplement|Placebo|Powder 74g within 250ml of water, 3 times per day during 7 days before surgery
16116158|NCT02041858|Other|Altered Alarm Settings|An altered set of alarm parameter settings
16116159|NCT02041845|Radiation|45 Gy in 30 fractions|3D conformal thoracic radiotherapy at a total dose of 45 Gy in 30 fractions, 2 fractions per day, 5 days a week
16116160|NCT02041845|Radiation|60 Gy in 40 fractions|3D conformal thoracic radiotherapy at a total dose of 60 Gy in 40 fractions, 2 fractions per day, 5 days a week. If doses to organs at risk exceed normal tissue tolerance, the dose may be lowered to a minimum of 54 Gy.
16116161|NCT02041832|Other|Conventional Holter monitoring|Patients undergo 72h Holter monitoring
16116162|NCT02041832|Device|Implantable loop recorder|Implantation of loop recorder with follow-up by remote monitoring
16116163|NCT02041819|Drug|Nimotuzumab|Nimotuzumab: 200mg,IV once a week for 6 weeks during chemotherapy (days 1,8,15,22,29,36).
16116164|NCT02041793|Procedure|Laparoscopic cystogastrostomy|Patients undergo drainage of pseudocyst by laparoscopic technique
16116165|NCT02041793|Procedure|Endoscopic cystogastrostomy|Endoscopic cystogastrostomy or cystoduodenostomy will be performed either under direct endoscopic or endosonography guidance
16116166|NCT02041780|Procedure|Shearwave electrography|
16116167|NCT02041767|Drug|Ertapenem|One single injection of 1g of ertapenem before surgery
16116168|NCT02041754|Device|IQP-AK-102|
16116169|NCT02041754|Device|Placebo|
16116170|NCT02041741|Behavioral|Weekly tips|Participants in this condition receive weekly a more in-depth tip to increase feelings of happiness involving a (doing and experiencing) task
16116171|NCT02041741|Behavioral|Daily Tips|Participants in this condition receive daily a set of small tips aimed at increasing happiness
16116172|NCT02041715|Drug|TKM-100802 for Injection|IV infusion
16116173|NCT02041715|Drug|Placebo|IV infusion
16116174|NCT02041702|Diagnostic Test|Non-Diagnostic Cardiac MRI scan|
16116175|NCT02041689|Behavioral|Interview|Each participant will complete two interview sessions with the primary investigator. Each interview will be conducted in a private, quiet room. Parents may choose to remain with the child during the interview if they would like, but only the responses of the child will be analyzed. Each interview session will last no more than one hour; if the child is not able to respond to each of the primary interview questions during this time, a second follow-up session will be scheduled so that the remainder of the questions can be answered. All interviews will be audio-recorded and transcribed.
16116176|NCT02041689|Behavioral|Observations|Observations help to give insights about interpersonal interactions, actions, non-verbal cues, and the activities and function of areas within the hospital. Three kinds of observation will be used: participant observation, non-participant observation, and guided activities. These observations will be conducted to learn more about the hospital environment as it intersects with the learning experiences of the participants.
16116177|NCT02041689|Behavioral|Guided Activities|"This study will use three different types of arts and play-based activities to give participants a variety of ways to express their thoughts and perceptions of what it is like to learn about their cancer diagnosis and treatment.
~The first activity will be a guided medical play opportunity that prompts the child to use actual medical equipment while taking care of a doll.
~For the second activity, the child will be given a digital camera to use and a prompt that asks them to photograph things and individuals in the hospital that have helped them to learn about their diagnosis and treatment.
~The third activity will be an open-ended art prompt in which the child will create an artistic representation of what it means to have cancer and get treatment."
16116178|NCT02041676|Procedure|Chest physiotherapy|
16116179|NCT02041676|Procedure|Usual surveillance|Usual surveillance of the non invasive ventilation without chest physiotherapy.
16116180|NCT02041663|Biological|BNP|Repeated brain natriuretic peptide dosages and cardiac echographies up to day 5
16116181|NCT02041650|Drug|Ticagrelor|
16116182|NCT02041611|Procedure|Blood collections|pts will have 6 blood collections (30ml/collection) throughout course of standard treatment
16116183|NCT02041598|Other|CHW Intervention|5 group educational sessions, 2 1v1 Visits with a CHW, Phone Calls as needed during 6-month study period
16116184|NCT02041572|Behavioral|Attentional bias retraining|Participants complete a computer-based intervention, which is designed to correct cognitive biases associated with PTSD by training to attend to neutral information rather than the trauma-related cue words.
16116185|NCT02041546|Drug|Lung lavage with surfactant|
16116186|NCT02041546|Drug|Bolus surfactant|
16116187|NCT02041533|Biological|Nivolumab|
16116188|NCT02041533|Drug|Gemcitabine|
16116189|NCT02041533|Drug|Cisplatin|
16116190|NCT02041533|Drug|Carboplatin|
16116191|NCT02041533|Drug|Paclitaxel|
16116192|NCT02041533|Drug|Pemetrexed|
16116193|NCT02041520|Drug|omega 3 fatty acids|omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.
16116194|NCT02041520|Other|placebo|olive oil in similar presentation of omega 3 fatty acids will be administered until progression or unacceptable toxicity develops during 6 months follow up.
16116195|NCT02041507|Other|Air insufflation method.|Air insufflation colonoscopy.
16116196|NCT02041507|Other|Water Immersion method.|Water Immersion during insertion, air insufflation during withdrawal.
16116197|NCT02041507|Other|Water Exchange method.|Water Exchange during insertion, air insufflation during withdrawal.
16116198|NCT02041494|Device|Ventralight|
16116199|NCT02041494|Device|Strattice|
16116200|NCT02041481|Drug|MEK inhibitor MEK162|Given PO
16116201|NCT02041481|Drug|leucovorin calcium|Given IV
16116202|NCT02041481|Drug|fluorouracil|Given IV
16116203|NCT02041481|Drug|oxaliplatin|Given IV
16116204|NCT02041481|Other|pharmacological study|Correlative studies
16116205|NCT02041481|Other|Laboratory Biomarker Analysis|Correlative Studies
16116206|NCT02041455|Drug|Melatonin and Placebo|
16116207|NCT02041455|Drug|Amitriptyline and Placebo|
16116208|NCT02041455|Drug|Melatonin and Amitriptylin|
16116209|NCT02041442|Procedure|Electrical mapping of the urinary bladder|
16116210|NCT02041429|Drug|Ruxolitinib|
16116211|NCT02041429|Drug|Paclitaxel|
16116212|NCT02041390|Other|SMS reminder|Each month after stent implantation, one investigator sent a text massage by SMS to inform patients the necessity of regular stent removal/exchange and the disadvantage of delayed management, and to remind them the appropriate date back to the hospital for stent management. Patients were requested to response by SMS and were encouraged to contact with the investigator if they had any questions about stent management.
16116213|NCT02041390|Other|Conventional reminder|After stent implantation, all patients received oral instruction about further management. If single or multiple plastic stents were inserted, patients were informed back to our hospital at 3 months for stent removal/exchange; if FCSEMS was inserted, they were informed back to the hospital at 6 months.
16116214|NCT02041377|Device|Karajishi TS Investigational Blood Glucose Monitoring System|Subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi TS Investigational Blood Glucose Monitoring System with no training. All BG results were compared to reference method results obtained from subject capillary plasma. Also, study staff tested subject venous blood and BG results were compared to reference method results obtained from subject venous plasma.
16116215|NCT02041351|Drug|Docetaxel|evaluate the activity of docetaxel on, metastatic lesions when measured after 4 cycles of chemotherapy
16116216|NCT02041338|Drug|Paclitaxel and carboplatin|
16116217|NCT02041338|Drug|Paclitaxel|
16116218|NCT02041338|Drug|Epirubicin and Paclitaxel|
16116219|NCT02041325|Drug|Lenalidomide|Subjects will receive oral CC-5013 (lenalidomide) at 25 mg qd for 7 days prior to and 7 days after the vaccine.
16116220|NCT02041325|Drug|Placebo|Subjects will receive placebo for 7 days prior to and 7 days after the vaccine.
16116221|NCT02041312|Other|No intervention|No intervention will be needed.
16116222|NCT02041299|Drug|Deferiprone|
16116223|NCT02041299|Drug|Deferoxamine|
16116224|NCT02041286|Device|Karajishi Contour Investigational BG Monitoring System|Subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Karajishi Contour Investigational BG Monitoring System with no training. All BG results are compared to reference method results obtained from subject capillary plasma. Also, study staff test subject venous blood and BG results are compared to reference method results obtained from subject venous plasma.
16116225|NCT02041273|Drug|palbociclib isethionate (phase 1 and 2 studies)|125 mg palbociclib isethionate salt under overnight fasting conditions
16116226|NCT02041273|Drug|palbociclib isethionate (phase 1 and 2 studies)|125 mg palbociclib isethionate salt under minimal fasting conditions (1 hr before palbociclib administration and 2 hrs post dose)
16116227|NCT02041273|Drug|palbociclib commercial free base capsule|125 mg palbociclib commercial free base capsule under fed conditions ( moderate fat meal)
16116228|NCT02041260|Drug|Cabozantinib|
16116229|NCT02041247|Biological|VAC-3S|VAC-3S is administered via intra-muscular route in the arm.
16116230|NCT02041234|Procedure|Roux-en-Y Gastric Bypass (RYGB)|Roux-en-Y Gastric Bypass (RYGB) as per standard surgical protocol, with a 30 cc gastric pouch, 50 cm biliopancreatic limb and 100cm gastrointestinal limb.
16116231|NCT02041234|Drug|Incretin analogues|Incretin analogues: Liraglutide up to 1.8 mg daily
16116232|NCT02041234|Drug|Xenical|Xenical: Up to 120 mg tds
16116233|NCT02041234|Drug|SGLT2 inhibitors|SGLT2 inhibitors: Empagliflozin up to 25mg daily, Canagliflozin up to 300mg daily
16116234|NCT02041234|Drug|DPP-4 Inhibitors|Sitagliptin up to 100 mg daily, Linagliptin up to 5mg daily
16116235|NCT02041221|Drug|SPARC1316 Dose 1|The subjects will receive SPARC1316.
16116236|NCT02041221|Drug|Placebo|
16116237|NCT02041221|Drug|SPARC1316 Dose 2|
16116238|NCT02041221|Drug|SPARC1316 Dose 3|
16116239|NCT02041221|Drug|SPARC1316 Dose 4|
16116240|NCT02041221|Drug|SPARC1316 Dose 5|
16116241|NCT02041208|Procedure|kidney transplantation|kidney transplantation
16116242|NCT02041195|Drug|RM-493|
16116243|NCT02041195|Drug|Placebo|
16116244|NCT02041182|Behavioral|Pre-Visit Questionnaire|
16116245|NCT02041169|Other|Subsequent walking performance|Subsequent walking performance
16116246|NCT02041156|Other|aerobic and resistance training|
16116247|NCT02041156|Other|aerobic combined with balance training|
16116248|NCT02041143|Dietary Supplement|Milk protein|Study product will provide 25 g of protein to subjects.
16116249|NCT02041143|Dietary Supplement|Placebo|Product with no protein
16116250|NCT02041130|Device|Renal Denervation|
16116251|NCT02041117|Drug|Rosuvastatin|Rosuvastatin, 10mg for 4-weeks, then according to the results of the LDL-C, adjust dose of rosuvastatin, maximum to 20 mg/d, to reduce LDL-C under 70 mg/dl for two years.
16116252|NCT02041104|Dietary Supplement|Bread with added beta-glucans|Participants will daily consume bread with high content of beta-glucans. They will approximately consume 6 g beta-glucans per day in 200 g of bread. Intervention period will be 4 weeks. Meanwhile the participants will remain their usual eating habits except consuming any pro- or pre-biotics
16116253|NCT02041104|Dietary Supplement|Placebo Comparator: Bread without added beta-glucans|Participants will daily consume placebo bread without any added beta-glucans (approximately 200 g per day). Intervention period will be 4 weeks. Meanwhile the participants will remain their usual eating habits except consuming any pro- or pre-biotics.
16116254|NCT02041091|Drug|Tabalumab Auto-Injector|Administered SC
16116255|NCT02041091|Drug|Tabalumab Prefilled Syringe|Administered SC
16116256|NCT02041078|Procedure|Intrahepatic division of the right hepatic vein.|Ligation and division of the entrance of the right hepatic vein into the suprarenal cava vein are done at the end of transection of the liver parenchyma with CUSA.
16116257|NCT02041078|Procedure|Extrahepatic vein division|Standard surgical procedure with extrahepatic ligation/division of the right hepatic vein prior to parenchymal division with CUSA.
16116258|NCT02041065|Device|Waterjet induced dissection|Waterjet induced dissection of the liver during resection.Waterjet dissection device mechanically separates hepatic tissue from bile ducts and vessels, the latter two to be separately ligated.
16116259|NCT02041065|Device|CUSA induced dissection|Ultrasound based destruction of the liver
16116260|NCT02041052|Procedure|Subtotal gastrectomy as an adjunct to traditional whipple procedure.|Subtotal gastrectomy as an adjunct to traditional whipple procedure.
16116261|NCT02041052|Procedure|Conventional whipple procedure|All patients undergoing whipple procedure without risk for pancreaticojejunal anastomosis leakage.
16116262|NCT02041026|Dietary Supplement|probiotic yoghurt|The probiotic yoghurt will be prepared using lactobacillus NN20 isolated from Kimere (a traditional fermented food product) consumed in eastern part of kenya
16116263|NCT02041013|Other|Taking Card|Recordable greeting card-style discharge instruction card
16116264|NCT02041000|Other|Adipose Derived Stem Cells|
16116265|NCT02040987|Drug|AZD3293|AZD3293 oral solution - one single dose (low dose).
16116266|NCT02040987|Drug|AZD3293|AZD3293 oral solution - one single dose (high dose).
16116267|NCT02040987|Drug|Placebo|Placebo oral solution - one single dose
16116268|NCT02040987|Drug|Moxifloxacin|Moxifloxacin tablet - one single dose
16116269|NCT02040961|Device|ETView Double-Lumen Tube|Tracheal intubation is performed using a ETView Double-Lumen Tube
16116270|NCT02040948|Device|- Nexfin (Pulse Pressure Variation) - Radical 7 (Pleth Variability Index) - CardioQ (stroke volume)|
16116271|NCT02040935|Drug|Trastuzumab|600 mg SC Q3W by SID
16116272|NCT02040909|Drug|Propofol|Propofol, an anesthetic agent, is used to sedate the patients before endotracheal intubation. The propofol starting dose in all age groups will be 1.0 mg propofol/kg. After 5 patients per age group the next dose will be determined. Dose will be increased or decreased with 0.5 mg/kg for the next 5 patients. The study will be continued untill an adequate dose, that results in adequate sedation, good intubation conditions without hypotension, is determined. That dose will be valideted in another 5 patients per age group.
16116273|NCT02040883|Drug|Risperidone/Olanzapine/Quetiapine/Ziprasidone/Aripiprazole|Treated with a stable dose of an AAPD for at least three months before enrollment, which is suggested to attain the stable cognitive status.
16116274|NCT02040883|Drug|Tandospirone|Tandospirone，30mg per day
16116275|NCT02040870|Drug|LDK378|750 mg once daily
16116276|NCT02040857|Drug|Palbociclib|CDK 4/6 inhibitor
16116277|NCT02040857|Drug|Aromatase Inhibitor|Endocrine Therapy
16116278|NCT02040844|Drug|Received Cat-PAD Treatment 1 in Study CP007 [NCT01620762]|
16116279|NCT02040844|Drug|Received Cat-PAD Treatment 2 in Study CP007 [NCT01620762]|
16116280|NCT02040844|Drug|Received Cat-PAD Treatment 3 in Study CP007 [NCT01620762]|
16116281|NCT02040831|Biological|RSV LID ΔM2-2 Vaccine|10^5.0 plaque forming units (PFU); 0.5 mL dose delivered as nose drops (approximately 0.25 mL per nostril)
16116282|NCT02040831|Biological|Placebo Vaccine|0.5 mL dose delivered as nose drops (approximately 0.25 mL per nostril)
16116283|NCT02040818|Drug|tigecycline, N-acetylcysteine, heparin combination|
16116284|NCT02040818|Device|guide-wire exchange|
16116285|NCT02040805|Behavioral|Group Cognitive Behavioral Therapy|"Group therapy over approximately 20 weeks, based on a structured manual adapted from the individual CBT workbook for hoarding by Steketee and Frost (2006). Each session will be 2 hours in length and consists of weekly check-ins, psychoeducation about hoarding, developing understanding and awareness of one's hoarding symptoms and patterns, behavior modification, cognitive restructuring, goal-setting, motivational enhancement, in vivo and imaginal exposure for discarding and acquisition, executive skills training (organization, sorting, planning, decision-making, problem-solving, etc.), guidelines on establishing clutter buddies, and relapse prevention. Groups will be led by clinical postdoctoral psychology fellows in the Department of Psychiatry at UCSF."
16116286|NCT02040805|Behavioral|Peer Facilitated Support Group|Fifteen sessions of peer facilitated, group support, over the course of 20 weeks, based on a structured manualized approach (Buried in Treasures: Help for Compulsive Acquiring, Saving, and Hoarding). Each session will be 2 hours in length. In this model, two trained peers, usually, but not necessarily, with personal lived experience of hoarding, will guide the group chapter by chapter through the Buried in Treasures manual.
16116287|NCT02040792|Drug|TD-4208|
16116288|NCT02040792|Drug|Placebo|
16116289|NCT02040779|Drug|Beclomethasone dipropionate breath-actuated inhaler|Beclomethasone dipropionate (BDP) breath-actuated inhaler (BAI) given in dosages of either 40 mcg/inhalation or 80 mcg/inhalation. Study drug was administered twice each day, in the morning and in the evening, after the completion of the asthma symptom score and the PEF measurements, in that order.
16116290|NCT02040779|Drug|Placebo breath-actuated inhaler|Placebo was provided in matching breath-actuated inhaler (BAI) devices. The placebo devices were identical to the devices used to deliver active drug. Placebo was administered twice each day, in the morning and in the evening, after the completion of the asthma symptom score and the PEF measurements, in that order.
16116291|NCT02040779|Drug|albuterol/salbutamol|Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period
16116292|NCT02040766|Drug|Beclomethasone dipropionate BAI|Beclomethasone dipropionate (BDP), was delivered by a single inhalation using a breath-actuated inhaler (BAI) at levels of 40 mcg or 80 mcg per inhalation, twice each day.
16116293|NCT02040766|Drug|Placebo BAI|Placebo was delivered by a single inhalation using a breath-actuated inhaler (BAI) twice each day.
16116294|NCT02040766|Drug|albuterol/salbutamol 90 mcg|Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
16116295|NCT02040766|Drug|Beclomethasone dipropionate MDI|Beclomethasone dipropionate (BDP), was delivered by a single inhalation using a metered-dose inhaler (MDI) at levels of 40 mcg or 80 mcg per inhalation, twice each day.
16116296|NCT02040766|Drug|Placebo MDI|Placebo was delivered by a single inhalation using a metered-dose inhaler (MDI) twice each day.
16116297|NCT02040753|Behavioral|Intensive Lifestyle Intervention|Intensive Lifestyle intervention at Ubberup Folk High School for 10-14 weeks. Daily exercise for 1-3hrs. Calorie restriction. Education within Nutrition, exercise and healthy living in general.
16116298|NCT02040727|Behavioral|Resistance Training|Supervised strength training 3 days per week for 24 weeks
16116299|NCT02040727|Behavioral|No Resistance Training|No supervised strength training throughout the study
16116302|NCT02040662|Procedure|Continuous Thoracic Epidural Block|Before anesthesia, continuous thoracic epidural block of T5/T6 is performed (Portex Epidural Minipack set). Identification of paravertebral space by loss of resistance technique (air). A catheter is advanced ca. 3-5 cm, and test dose with 2 ml of lidocaine 2% i injected. At the end of surgery syringe with 0,25% bupivacaine with epinephrine 1:200.000 is connected to catheter and 6 ml bolus is injected, followed by an infusion of the same mixture at 0,06 ml/kg/h for postoperative pain management.
16116303|NCT02040662|Procedure|Continuous Thoracic Paravertebral Block|Before anesthesia, continuous thoracic paravertebral block of T5/T6 is performed (Portex Epidural Minipack set). Identification of paravertebral space by loss of resistance technique (normal saline). After injection of 5-10 ml of normal saline a catheter is advanced medially ca. 5 cm. At the end of surgery syringe with 0,25% bupivacaine with epinephrine 1:200.000 is connected to catheter and 20 ml bolus is injected, followed by an infusion of the same mixture at 0,08 ml/kg/h for postoperative pain management
16116304|NCT02040662|Procedure|Patient-Controlled Analgesia with Morphine|"Once arrived at the PACU all patients are placed on a postoperative analgesia regimen, that include:
~patient-controlled analgesia with morphine (bolus dose 2 mg, lockout time 10 min)
~paracetamol 1000 mg iv every 8 hrs
~ketoprofen 100 mg iv every 12 hrs"
16116305|NCT02040649|Other|Non-sedation|Patients are awake or have natural sleep during mechanical ventilation. Pain is treated with morphine iv.
16116306|NCT02040649|Other|Control, sedation (propofol, midazolam)|Continuous iv-sedation (propofol first 48 hours, from then midazolam) to Ramsey 3-4 with a daily wake up attempt, where sedation is stopped until patient is awake.
16116307|NCT02040636|Biological|Tetanus and Diphtheria Toxoids Adsorbed Combined with Component Pertussis Vaccine and IPV|0.5 mL, Intramuscular
16116308|NCT02040636|Biological|Hepatitis B vaccine|0.5 ml, Intramuscular
16116309|NCT02040623|Drug|R348 Ophthalmic Solution, 0.2%|R348 Ophthalmic Solution 0.2% 2 drops per eye twice a day
16116310|NCT02040623|Drug|R348 Ophthalmic Solution, 0.5%|R348 Ophthalmic Solution, 0.5% 2 drops per eye twice a day
16116311|NCT02040623|Other|Placebo Ophthalmic Solution|Placebo Ophthalmic Solution 2 drops per eye twice a day
16116312|NCT02040610|Radiation|Hypofractionated Proton Therapy|
16116314|NCT02040584|Drug|Minimisation of TAC|•EVR: Treatment started at a total daily dose of 2 mg within 24 hours after randomisation. The dose of EVR was adjusted upon reaching trough levels (C-0h) in whole blood of 3-8 ng/mL. The daily dose (in two administrations) of EVR may have been modified to maintain trough levels (C-0h) in whole blood of 3-8 ng/mL until Week 52 post-transplant. •TAC: Once confirmation was obtained, beginning in Week 5, that trough levels (C-0h) in whole blood of EVR were between 3-8 ng/mL, minimisation of TAC began, in order to reach trough levels (C-0h) of TAC in whole blood of ≤5 ng/mL no later than four weeks after randomisation (Week 8), which were levels that should have been maintained until Week 52 post-transplant. •MMF was withdrawn at the same time that EVR was introduced. •oral corticosteroids was administered in accordance with local clinical practice, although a therapeutic strategy free of corticosteroids was permitted
16116315|NCT02040584|Drug|TAC + MMF + corticosteroids|•Dose of TAC: Trough levels (C-0h) of TAC in whole blood should have been maintained between 6-10 ng/mL until Week 52 post-transplant. •Dose of MMF: Doses of 500-1000 mg/12 hrs was maintained until Week 52. •Corticosteroids: During the study, oral corticosteroids was administered in accordance with local clinical practice, although a therapeutic strategy free of corticosteroids was permitted (e.g. in patients with a history of HCV). It was recommended in any case that corticosteroids not be administered beyond Week 24 post-transplant except in cases of hepatopathy of autoimmune origin. At each centre all patients should have followed the same administration protocol for corticosteroids based on history of HCV.
16116316|NCT02040571|Device|Closed Loop|A total of 24 participants with T1 Diabetes with sensor augmented insulin pump therapy (SAPT) experience will be recruited from four tertiary hospitals and will enter an un-masked randomised-control crossover trial, with a run-in period followed by two phases (in-hospital and at-home) in each of two stages (Closed Loop and Open Loop in random order). Closed Loop will be the intervention for this study, and its performance will be assessed compared to Open Loop (control treatment).
16116317|NCT02040571|Device|Open Loop|"The performance of closed loop system will be compared to open loop system (Sensor Augmented Pump Therapy). Therefore, the Open Loop system will be the control treatment.
~In stage 1 of study, participants are randomized to either closed loop (CL) or open loop (OL). In stage 2, all participants will be crossed to the opposite study arm.
~Throughout the study, those who randomised to OL will receive exactly the same medical attention as the CL participants."
16116318|NCT02040558|Drug|MNK-010|
16116319|NCT02040532|Drug|Gabapentin|The study is a 7-week intervention study using open-label gabapentin at bedtime with a scheduled dose titration from 100-mg for one week, followed by 300-mg for 3 weeks, and then 600-mg for 3 weeks.
16116320|NCT02040519|Behavioral|Filling out voiding diaries.|
16116321|NCT02040506|Drug|IGN523|Given intravenously every week for 8 weeks. Dosing beyond 8 weeks will be permitted for subjects meeting criteria for ongoing clinical benefit and acceptable safety.
16116322|NCT02040493|Radiation|Intra-operative radiation therapy (IORT)|All subjects will receive IORT at the time of lumpectomy.
16116323|NCT02040480|Drug|GSK2110183 Gelatin Capsule|White opaque hard gelatin capsule with a unit dose strength of 25 milligrams (mg) for oral administration
16116324|NCT02040480|Drug|GSK2110183 IR Tablet|White round biconvex film coated IR tablet with a unit dose strength of 25 mg for oral administration
16116325|NCT02040454|Drug|Paclitaxel|
16116326|NCT02040454|Procedure|Standard Therapy|
16116327|NCT02040441|Drug|Spironolactone|
16116328|NCT02040441|Drug|Placebo|
16116329|NCT02040441|Drug|Standard care|Standard diabetes care
16116330|NCT02040428|Biological|EVARREST™ Fibrin Sealant Patch|
16116331|NCT02040428|Biological|Topical hemostat|
16116332|NCT02040415|Drug|DW-1030(eperisone HCl) 75mg|
16116333|NCT02040415|Drug|Myonal Tab.(eperisone HCl) 50mg|
16116334|NCT02040415|Drug|Placebo drug of DW-1030|
16116335|NCT02040415|Drug|Placebo drug of Myonal Tab.|
16116336|NCT02040402|Biological|7-valent pneumococcal conjugated vaccine|Pneumococcal vaccine 3+1 and 2+1 schedule comparison
16116337|NCT02040402|Biological|7-valent pneumococcal conjugated vaccine|3+1 doses vs 2+1 doses
16116338|NCT02040389|Behavioral|Picture book|Arm with showing and explaining for parents about perioperative typical surgery site/wound view by study's team
16116339|NCT02040389|Behavioral|Standard preoperative education|Arm with standard, verbal explaining for a parents about perioperative site/wound view
16116340|NCT02040376|Drug|Metformin|Metformin and placebo doses will be 500 mg/m2 po daily given in 2 doses for one week and if there are no concerns increased to 1000 mg/m2 po daily given in 2 doses for the rest of the 12 week trial. The investigators will use the closest dose according to body surface area (250-500-750-1000) BID.
16116341|NCT02040376|Drug|Placebo|Metformin and placebo doses will be 500 mg/m2 po daily given in 2 doses for one week and if there are no concerns increased to 1000 mg/m2 po daily given in 2 doses for the rest of the 12 week trial. The investigators will use the closest dose according to body surface area (250-500-750-1000) BID.
16116342|NCT02040363|Procedure|Muscular biopsy|
16116343|NCT02040363|Other|5-10 weeks sport training|
16116344|NCT02040350|Drug|Pralidoxime|Pralidoxime was compared to placebo to study the effects of the drug on mortatlity
16116345|NCT02040324|Device|Laryngeal mask with gastric access|
16116346|NCT02040324|Device|Endotracheal tube|
16116347|NCT02040311|Drug|Topiramate 96 mg daily|
16116348|NCT02040311|Drug|Topiramate 192 mg daily|
16116349|NCT02040311|Drug|Placebo|
16116435|NCT02039635|Dietary Supplement|Korean Red Ginseng|Given Orally
16116352|NCT02040285|Drug|Bisacodyl & PEG-CS|"the day before the CTC:
~low fiber diet
~at 15.00: 2 tablets of bisacodyl (5 mg)
~at 17.00: 1 litre of PEG-CS
~liquid diet
~the day of the exam:
~at home: 2 tablets of bisacodyl (5 mg)
~at the Hospital (3 hours after tablets intake): 90 ml of Iopamidol in 500 ml of water
~at the Hospital (5 minutes after Iopamidol intake): 10 mg of Metoclopramide mono chlorohydrate monohydrate im"
16116353|NCT02040285|Drug|Iopamidol|"the day before CTC:
~low fiber diet
~at 15.00: 90 ml of Iopamidol in 250 ml of water
~at 17.00: 90 ml of Iopamidol in 250 ml of water
~at 20.00: start liquid diet"
16116354|NCT02040272|Procedure|(Extended) pleurectomy decortication|
16116355|NCT02040246|Drug|Repaglinide|Initial dose of repaglinide 0.5 mg once daily. During the dose titration period of 1 week, the dose of repaglinide could be titrated up to 1 mg three times daily, according to fasting glucose values. The minimal dose was repaglinide 0.5 mg three times daily.
16116356|NCT02040246|Drug|Metformin|Initial dose of metformin 250mg once daily. During the dose titration period of 1 week, the dose could be titrated up to metformin 500 mg three times daily, according to fasting glucose values.
16116357|NCT02040233|Drug|BAY1067197 (10 mg)|10 mg BAY1067197 for 7 d treatment once daily as oral application
16116358|NCT02040233|Drug|BAY1067197|The dose escalation to the second dose step will proceed only if the previous dose step has shown acceptable safety and tolerability 5 mg / or 10 mg / or 20 mg BAY1067197 for 7 d treatment as oral application.
16116359|NCT02040233|Drug|Placebo (10 mg)|10 mg Placebo for 7 d treatment once daily as oral application
16116360|NCT02040233|Drug|Placebo|5 mg / or 10 mg / or 20 mg Placebo for 7 d treatment once daily as oral application
16116361|NCT02040220|Drug|Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)|2 mg of Eylea will be treated per one injection at more than one months interval usually.
16116362|NCT02040207|Drug|AM-101|AM-101 gel for intratympanic injection
16116363|NCT02040194|Drug|AM-101|AM-101 gel for intratympanic injection
16116364|NCT02040194|Drug|Placebo|Placebo gel for intratympanic injection
16116365|NCT02040155|Device|Novel nano-scintillator fiber-optic dosimeter (nanoFOD)|This is an observational study whose purpose is to determine the feasibility of using a novel nano-scintillator fiber-optic dosimeter (nanoFOD) for the real time dosimetric monitoring of brachytherapy treatment.
16116366|NCT02040142|Procedure|HIPEC|
16116367|NCT02040142|Drug|Mitomycin C|
16116368|NCT02040129|Device|Acrysof Toric IOL|Lens implantation following cataract surgery
16116369|NCT02040116|Drug|Rituximab Infusion|Participants will receive their first infusion of rituximab at the standard infusion rate provided in the manufacturer labeling. If they tolerate this infusion with a grade 2 of less infusion-related reaction, the next infusion will be administered as a 90 minute rapid infusion.
16116370|NCT02040103|Device|pneumatic compression|All IPC devices intended for DVT prophylaxis are acceptable in the study. Sequential devices (cuffs have several chambers) are preferred, but non-sequential (cuffs have single chambers) are acceptable.
16116371|NCT02040090|Drug|Active rabies vaccine (US-FDA approved)|A 1.0 ml dose of active vaccine (2.5 IU/ml), will be given on 5 occasions, on Days 0, 3, 7, 14, and 28 On day 0, the day when the HRIG is given, the first vaccine dose could be given within few minutes from the time of HRIG injection was given and never be administered into the same anatomical site as the HRIG.
16116372|NCT02040077|Behavioral|Computer + Fluency|
16116373|NCT02040077|Behavioral|Computer Only|
16116374|NCT02040077|Behavioral|Treatment as Usual|
16116375|NCT02040064|Drug|Gefitinib|Oral tablet
16116376|NCT02040064|Drug|Tremelimumab|IV
16116377|NCT02040051|Behavioral|Sound isolation / Music therapy|"Sound isolation: we will used headphones Noise Candelling HI-FI Polk Audio UF 8000 Control Talk for sound isolation.
~Music therapy: we will used relaxing Zen music. Light Reiki Touch (Album: Merlin's Magic; Composer: Andreas Mock. Published in 1995 by Inner Worl Music)"
16116378|NCT02040038|Behavioral|LIVE|3-D Virtual Environment for DSMT/S
16116379|NCT02040038|Behavioral|Website|2-D Website participation for DSMT/S
16116380|NCT02040012|Drug|AZP-531|
16116381|NCT02040012|Drug|Placebo|
16116382|NCT02039999|Other|Nebulised citric acid in serial dilutions|Citric acid will be delivered in serial dilutions as per the clinical trials unit standard operating procedure for cough challenge using KoKo Digidoser, based on ERS guidelines. Challenge will be repeated until C5 (5 coughs in 30 seconds following challenge) is elicited.
16116383|NCT02039999|Other|Nebulised ATP solution in serial dilutions|ATP solution will be delivered in serial dilutions as per the clinical trials unit standard operating procedure for cough challenge using KoKo Digidoser, based on ERS guidelines. Challenge will be repeated until C5 (5 coughs in 30 seconds following challenge) is elicited.
16116384|NCT02039999|Other|Nebulised TRPA1 agonist solution in serial dilutions|TRPA1 agonist will be delivered in serial dilutions as per the clinical trials unit standard operating procedure for cough challenge using KoKo Digidoser, based on ERS guidelines. Challenge will be repeated until C5 (5 coughs in 30 seconds following challenge) is elicited.
16116385|NCT02039973|Behavioral|Task-sharing approach to group therapy|"Participants will also identify, select and clarify common concerns/problems; provide orientation to steps in problem-solving; break down identified problems into manageable pieces; choose pieces of problem to address in facilitated discussion of problem solving for implementing solutions; support the sharing of feedback of strategies used in problem-solving and maintaining pleasurable activities.
~Additionally, the intervention to aim to effect behavior by: explaining the links between problems, negative thoughts, choices made on a day-to-day basis, behaviors, and mood (symptoms of depression); facilitate sharing of practical skills to tackle problems, to change mood-related thoughts, choices and/or behaviors; offer and provide feedback on homework assignments to encourage practice of skills; and help participants attribute reported improvements to the use of new skills during feedback sessions."
16116386|NCT02039973|Behavioral|Enhanced standard of care|
16116387|NCT02039960|Drug|Bupropion|Bupropion is a weak catecholamine reuptake inhibitor predominantly affecting serotonin, norepinephrine and dopamine and is approved for depression, smoking cessation and seasonal affective disorder.
16116388|NCT02039947|Drug|Dabrafenib|Dabrafenib will be provided as 50 mg and 75 mg capsules
16116389|NCT02039947|Drug|Trametinib|Trametinib will be provided as 0.5 mg and 2.0 mg tablets
16116436|NCT02039635|Dietary Supplement|Placebo|Given Orally
16116437|NCT02039596|Other|Diet|
16116390|NCT02039934|Other|High intensity interval training|"The intervention consists of 30 minute sessions of high-intensity interval training on a bicycle ergometer three times per week.
~Training program: After 5 minutes of warm-up the subject cycles for 10 intervals of 60 s. at 90 % maximum effort separated 60 s at 20% maximum effort, based on a previously performed spiroergometry, followed by 5 minutes of cool-down."
16116391|NCT02039908|Drug|Methylphenidate|Children will receive a double-blind assessment to determine their optimal starting dose of Concerta. Doses will be adjusted over the course of the school year and inceased if tolerance to the medication is detected.
16116392|NCT02039895|Radiation|HITS|Helical irradiation of the total skin by helical tomotherapy
16116393|NCT02039869|Device|Confocal endomicroscopy|The probe allows microscopic evaluation of tissue in real time during endoscopy.
16116394|NCT02039869|Drug|Proton pump inhibitor|Acid suppressing medication (over the counter)
16116395|NCT02039869|Drug|Sucralfate|Coating agent for damaged intestinal lining.
16116396|NCT02039856|Other|Multilevel stakeholder engagement|Structured, in-person stakeholder panel meeting of VA network, VA medical center, and primary care and women's health leaders using modified Delphi panel techniques to come to consensus on a quality improvement (QI) roadmap within each participating VA network, followed by intermittent progress reporting and post-24 months in-person capstone stakeholder panel meetings
16116397|NCT02039856|Other|Quality improvement (QI) education/training|Initial in-person and ongoing virtual team training in QI principles, methods, and project proposal development and refinement
16116398|NCT02039856|Other|Technical support|Research team provided technical review of and feedback on local QI project proposals, helped develop and/or recommend process/outcome measures, identified and shared relevant published literature (e.g., measures, interventions), and provided general technical support (e.g., how to analyze local data, how to conduct a local focus group)
16116399|NCT02039856|Other|Formative feedback|Research team provided aggregated all-site and local data from baseline patient and provider/staff surveys, 12-month patient surveys, and other data and findings to local teams for ongoing and new QI project idea development
16116400|NCT02039856|Other|External practice facilitation|Within and across site calls with local teams to review progress, identify needs, help solve problems, discuss current and new projects, as well as potential for spread
16116401|NCT02039856|Other|National policy guidance|VA Handbooks on policy and practice for PACT implementation guidance and on delivery of comprehensive women's health services disseminated to all VA facilities
16116402|NCT02039843|Other|Service Dog or Emotional Support Dog|"Emotional Support Dog. Service Dog - an assistance dog specifically trained to perform tasks that are specific to the person's disability and has public access privileges.
~-Emotional Support Dog - a dog that has earned AKC Good Canine Citizen certification and provides emotional support and comfort to the Veteran."
16116403|NCT02039843|Other|Emotional Support Dog|-Emotional Support Dog - a dog that has earned AKC Good Canine Citizen certification and provides emotional support and comfort to the Veteran.
16116404|NCT02039830|Behavioral|Group physiotherapy|Multimodal Group physiotherapy 12 weeks of weekly Group physiotherapy treatments including education and pelvic floor muscle exercises
16116405|NCT02039830|Behavioral|Individual one-on-one physiotherapy|Multimodal Individual physiotherapy 12 weeks of weekly Individual physiotherapy treatments including education and pelvic floor muscle exercises
16116406|NCT02039817|Drug|IDN-6556|
16116407|NCT02039804|Drug|Corticosteroids|Intra-bursal injection
16116408|NCT02039804|Device|Hyaluronic acid|Intra-bursal injection
16116409|NCT02039791|Biological|Nimotuzumab|200mg/w,weekly, 6 weeks
16116410|NCT02039791|Drug|Carboplatin|AUC 6, d1，1 cycle/21d, 2 cycles
16116411|NCT02039791|Drug|Paclitaxel|"175 mg/m2, d1
~1 cycle/21d, 2 cycles."
16116412|NCT02039778|Radiation|Stem Cell Radiotherapy (ScRT) and Temozolomide|"Stem Cell Radiotherapy (ScRT) and Temozolomide:
~The postoperative surgical bed + edema + margin & the ipsilateral subventricular zone (contoured as a 5mm rim of tissue around the ipsilateral lateral ventricles) will be included within the initial target volume and treated to 46 Gy in 23 fractions. After 46 Gy, the conedown or boost volume (surgical cavity + margin) will be treated to a total of 60 Gy, with seven additional fractions of 2 Gy each (14Gy boost dose).
~Temozolomide will be administered continuously from day 1 of radiotherapy to the last day of radiation at a daily oral dose of 75 mg/m2. The drug will be administered orally on an empty stomach, the first dose to be given the night prior or morning of the first radiation fraction, and continued until the last radiation fraction is completed (including weekends and holidays)."
16116413|NCT02039765|Drug|Brimonidine tartrate|
16116414|NCT02039752|Other|Treatment|
16116415|NCT02039739|Device|Orsiro™ Drug Eluting Stent group|
16116416|NCT02039726|Drug|Quizartinib|20 or 30 mg quizartinib tablets administered orally once daily
16116417|NCT02039726|Drug|Salvage Chemotherapy|Low dose cytarabine (LoDAC); mitoxantrone, etoposide, and intermediate-dose cytarabine (MEC); or fludarabine, cytarabine, and granulocyte colony stimulating factor (G-CSF) with idarubicin (FLAG-IDA) administered during 28-day cycles
16116418|NCT02039713|Device|DeSyne drug eluting stent group|
16116419|NCT02039700|Drug|Lesinurad 400 mg|
16116420|NCT02039700|Drug|[14C]lesinurad (100 μg per 10 mL)|
16116421|NCT02039687|Drug|ARA 290|A small peptide that activates the innate repair receptor to induce anti-inflammatory and tissue repair mechanisms.
16116422|NCT02039687|Other|Placebo|Formulation buffer
16116423|NCT02039674|Biological|Pembrolizumab|IV on Day 1 of each 3-week cycle prior to chemo/immunotherapy
16116424|NCT02039674|Drug|Paclitaxel|IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
16116425|NCT02039674|Drug|Carboplatin|IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
16116426|NCT02039674|Biological|Bevacizumab|IV on Day 1 of each 3-week cycle
16116427|NCT02039674|Drug|Pemetrexed|IV on Day 1 of each 3-week cycle
16116428|NCT02039674|Biological|Ipilimumab|IV on Day 1 of each 3-week cycle for a maximum of 4 administrations
16116429|NCT02039674|Drug|Erlotinib|Orally tablet once daily
16116430|NCT02039674|Drug|Gefitinib|Oral tablet once daily
16116431|NCT02039661|Drug|Lidocaine Spray|These patients received 2 puff lidocaine spray
16116432|NCT02039661|Drug|Placebo|
16116433|NCT02039648|Other|Rumex acetosa L. extract|
16116434|NCT02039648|Other|Placebo|
16116438|NCT02039583|Other|Smoke-free legislation|The intervention under study is the smoke-free legislation in England introduced overnight on 1 July 2007. As of this date virtually all enclosed public places and workplaces were by law required to be smoke-free. More detail can be found via the link provided at the end of this protocol.
16116439|NCT02039570|Other|Transvaginal scan|transvaginal scan conducted using duplex ultrasonography
16116440|NCT02039557|Genetic|NiCord®/CordIn™|
16116441|NCT02039544|Drug|Xuebi formula|
16116442|NCT02039544|Drug|placebo|
16116443|NCT02039531|Biological|Plasma rich in growth factors|
16116444|NCT02039531|Drug|Hyaluronic Acid|
16116445|NCT02039518|Drug|gemcitabine|gemcitabine 1000mg/m2，d1，d8，Q3W
16116446|NCT02039518|Other|observation group|observation group
16116447|NCT02039505|Drug|Vedolizumab|Vedolizumab intravenous infusion
16116448|NCT02039505|Drug|Vedolizumab placebo|Vedolizumab placebo
16116449|NCT02039492|Procedure|Sympathetic Renal Denervation|
16116450|NCT02039492|Drug|Treatment with aldactone|
16116451|NCT02039479|Drug|Lithium Carbonate|Lithium as Add on to every necessary treatment as usual
16116452|NCT02039479|Drug|Placebo|Placebo as ADD-on to every necessary treatment as usual
16116453|NCT02039466|Procedure|volume controlled ventilation|
16116454|NCT02039466|Procedure|pressure controlled ventilation|
16116455|NCT02039453|Drug|fentanyl doses|fentanyl doses 50μg (37.5kg to 62.5kg), 75μg (62.5kg to 87.5kg), 100μg (>87.5kg), single use Propofol doses 1.0mg/kg IV bolus loading, 20mg, IV bolus, titration (up to MOAAS 5)
16116456|NCT02039453|Drug|pethidine dose|pethidine dose 50mg, IV bolus (25mg if < 50kg or >70 years or significant co-morbidity), Propofol doses 1.0mg/kg IV bolus loading, 20mg, IV bolus, titration (up to MOAAS 5)
16116457|NCT02039440|Other|Blood draw|One-time blood draw
16116458|NCT02039427|Drug|Ketorolac|ketorolac 30 mg mixed with normal saline 1 ml : total volume of 2 ml
16116459|NCT02039427|Other|Dexamethasone|dexamethasone acetate10 mg : total volume of 2 ml
16116460|NCT02039427|Drug|Placebo|Normal saline 2 ml
16116461|NCT02039401|Biological|VM202|
16116462|NCT02039388|Procedure|Lavage of the Cavum uteri and proximal Fallopian tubes, performed in the luteal phase of the female cycle|
16116463|NCT02039375|Other|"Hopkins post tPA for ischemic stroke monitoring protocol"|"The Hopkins post tPA monitoring protocol includes: vital signs and neurochecks, per standard of care for the first two hours (every 15 minutes), then on arrival to unit, in one hour, every 2 hours for 8 hours, and every 4 hours to complete 24 hours."
16116464|NCT02039362|Drug|Tenofovir DF|Tenofovir DF will be started at week 28 of pregnancy and stopped or not, according to the physician's decision, at week 12 after birth
16116465|NCT02039349|Drug|PF-05190457|
16116466|NCT02039336|Drug|Dacomitinib|
16116467|NCT02039336|Drug|PD-0325901|
16116468|NCT02039336|Drug|Docetaxel|
16116469|NCT02039323|Drug|Tenofovir|
16116470|NCT02039323|Drug|Maraviroc|
16116471|NCT02039297|Other|Patient Centered Cloud-based Electronic System: Ambient Warning and Response Evaluation|Computer aided checklist and rounding tool implemented in the Intensive care unit environment
16116472|NCT02039284|Device|SES|SES group received the SES training in addition to traditional rehabilitation. Each SES session involved electrical stimulation followed by UE training in addition to home program.The novel SES programs were conducted three times per week, for 12 weeks. Each SES session involved electrical stimulation followed by UE training in addition to home program. The SES was applied to the forearm and whole hand with mesh glove for 20-30 minutes and arm with wrap for 20-30 minutes. The pulse width was set to 300 us for all stimulation levels. The frequency was set to 40-50 Hz.
16116473|NCT02039284|Device|VCT|The UE VCT programs were conducted three times per week, for 12 weeks. Each UE VCT session involved upper limb cycling training followed by UE training in addition to home program. The cycling program consisted of a warm-up exercise, twenty repetitions of hand push-up movements in the sitting position, UE cycling, and a cool-down exercise. The warm-up and cool-down exercises involved stretching and relaxing the head, neck, and the upper and lower body.
16116474|NCT02039284|Device|VRCIT|VRCIT group received the VRCIT training in addition to traditional rehabilitation, conducted three times per week, for 12 weeks. Each VRCIT session involved practice of functional tasks with the more affected UE followed by virtual-reality based eye-hand coordination tasks with the more affected UE for, in addition to home program, and restraint of the less affected UE for 3.5 to 4 hours per day. The functional training of the more affected UE focused on massive practice of functional activities using the more affected arm, with the principles of shaping and repetitive task practice applied during training.
16116475|NCT02039284|Device|traditional rehabilitation program|The absence of muscle contractions was controlled by the investigator the sham stimulation was carried out identically, but the stimulation amplitude was set to 0 milliampere(mA). Subjects were not informed about the stimulation level and were instructed to distract attention from the stimulation.
16116476|NCT02039271|Other|Music therapy|This will include 30 minutes before and after ambulation on post-op days 1 and 2. This will be contingent on when the participant had surgery the day prior and when they are ready and able to begin ambulating. Participants in the intervention group will do a VAS prior to listening to music and then afterward while those in the control group will do a VAS prior to and after each ambulation. Participants will be ambulating twice a day, in the AM and PM so the intervention will be given twice a day.
16116477|NCT02039258|Drug|CANA/MET XR FDC|Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination (FDC) tablet of 150 mg/1,000 mg
16116478|NCT02039245|Drug|CANA/MET XR FDC|Each tablet contains Canagliflozin/extended release Metformin (CANA/MET XR) fixed dose combination (FDC) of 150 mg/1,000 mg, to be taken orally (by mouth)
16116479|NCT02039232|Device|Pedicle screw system|
16116480|NCT02039219|Drug|Placebo|1 tablet of placebo, taken orally daily with water, approximately 30 minutes prior to breakfast for 6 weeks.
16116481|NCT02039219|Drug|10 mg Obeticholic Acid (OCA)|10 mg Obeticholic Acid (OCA) Study medication will be administered orally, once daily, approximately 30 minutes prior to breakfast for 6 weeks.
16116482|NCT02039206|Device|Deep TMS|1Hz Stimulation
16116519|NCT02038907|Biological|Hepatitis A Vaccine|Hepatitis A Vaccine IM injection
16116571|NCT02038634|Drug|Betamethasone|
16116483|NCT02039193|Behavioral|Cognitive behavioral therapy|CBT-manual (Zinbarg et al., 2006): Traditional cognitive-behavioral therapy (CBT) for GAD typically consists of psycho education of generalized anxiety disorder, relaxation training (RT), cognitive restructuring (CR) and with some in-vivo situational exposure for patients with overt behavioral avoidance (e.g., Barlow, Rapee, & Brown, 1992; Borkovec & Costello, 1993). Furthermore, imagery exposure as a GAD-specific form of in-sensu exposition will be applied to reduce experiential avoidance based on a well-introduced CBT-manual (Zinbarg et al., 2006). The manualized therapy follows an usual treatment format of 14 sessions to 50 minutes and a booster session after 6-months.
16116484|NCT02039180|Drug|AZD3293 oral solution|Subjects will receive AZD3293 as a tablet (Formulation A; Formulation B) and solution as a single dose on Day 1, Day 8 or Day 15.
16116485|NCT02039180|Drug|AZD3293 tablet formulation A|Subjects will receive AZD3293 as a tablet (Formulation A; Formulation B) and a solution as a single dose on Day 1, Day 8, or Day 15.
16116486|NCT02039180|Drug|AZD3293 tablet formulation B|Subjects will receive AZD3293 as a tablet (Formulation A; Formulation B) and a solution as a single dose on Day 1, Day 8 or Day 15.
16116487|NCT02039167|Device|Left atrial appendage occlusion|Percutaneous left atrial appendage closure using the WATCHMAN device.
16116488|NCT02039154|Behavioral|Aerobic and strength training group|A exercise training program will be developed individually for each subject with the goal of increasing duration and intensity consistent with modern training techniques. Workouts will vary with respect to mode (walk, cycle, swim), duration (30-60 minutes), and intensity (base, interval, recovery) to optimize the training response. Each subject will be assigned a personal trainer and a heart rate monitor so that every session is carefully tracked and recorded. For intervals, we will use the novel high intensity aerobic intervals (HAIT). Subjects will also perform strength training 1-2 days/week.
16116489|NCT02039154|Behavioral|Balance and flexibility group|For the balance and flexibility group, subjects will be encouraged to participate in yoga/tai chi/pilates classes that is approved by one of the exercise physiologists on the research team. The goal for this group is exercise classes that will be of benefit to them, but that will not include sustained aerobic, endurance exercise. In place of a group exercise class, subjects will have the option of purchasing videos for home use. The subjects will be encouraged to participate in some form of non-endurance training at least 3 days per week. Each subject will receive an exercise log in which they will be expected to record their training.
16116490|NCT02039141|Other|Every Little Step Counts Intervention|"Youth participants randomized to participate in the experimental group will attend weekly healthy lifestyles education session with their parent(s)/guardian(s) and will also attend exercise sessions 3 times a week for 12 weeks. The education sessions will cover topics such as healthy eating choices, roles and responsibilities of both parents and youth in the realm of the family unit as well as in youth's own health, and self esteem among other topics. The exercise sessions will incorporate both aerobic and resistance training as well as other free-play physical activities i.e. basketball, volleyball etc."
16116491|NCT02039128|Dietary Supplement|Krill oil or Fish oil|
16116492|NCT02039128|Dietary Supplement|Placebo|
16116493|NCT02039115|Drug|prednisone|6 weeks of prednisone and placebo therapy will be given over 6 weeks after both the first and second stage complete Barretts Excision.
16116494|NCT02039115|Drug|placebo|6 weeks of placebo therapy will be given in the same manner as the prednisone arm after the first and second stage complete Barretts excision.
16116495|NCT02039089|Drug|E2006 2.5 mg|
16116496|NCT02039089|Drug|E2006 10 mg|
16116497|NCT02039089|Drug|E2006 25 mg|
16116498|NCT02039089|Drug|Placebo|
16116499|NCT02039076|Drug|avatrombopag|
16116500|NCT02039063|Drug|E6011 2 mg/kg|
16116501|NCT02039063|Drug|E6011 5 mg/kg|
16116502|NCT02039063|Drug|E6011 10 mg/kg|
16116503|NCT02039063|Drug|E6011 15 mg/kg|
16116504|NCT02039050|Drug|Tiotropium|
16116505|NCT02039050|Drug|Aclidinium|
16116506|NCT02039037|Device|Acupuncture|Acupuncture Group, which will hold acupuncture needles brand Dong Bang 20x15 in specific spots for the treatment of low back pain.
16116507|NCT02039037|Device|Electroacupuncture (device 585)|Electro will be added through the use of electrical stimulation to the Electro Accurate use of the device 585 at the same points Pulse.
16116508|NCT02039024|Drug|18F- DTBZ|"During this study, subjects will receive a single i.v. administration of approximately 370MBq (10 mCi) 18F- DTBZ immediately prior to imaging. The dosage of DTBZ is 10 nmole. The effective dose in human body is about 5.6 mSV.
~During this study, subjects will receive a single i.v. administration of approximately 370MBq (10 mCi) florbetapir F-18 immediately prior to imaging. The dosage of DTBZ is 10 nmole. The effective dose in human body is about 5.6 mSV.
~The proposed dose for this study is based on our phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG (Lin 2010)."
16116509|NCT02039011|Drug|Indacaterol|Participants receive indacaterol for 2 to 4 weeks. Participants then enter a washout period and after the washout period receive the alternative treatment arm.
16116510|NCT02039011|Drug|Indacaterol and tiotropium|Participants receive indacaterol and tiotropium for 2 to 4 weeks. Participants then enter a washout period and after the washout period receive the alternative treatment arm.
16116512|NCT02038985|Other|Participants will receive ICG Dye|Participants will receive ICG Dye preoperatively for use in the Visual Diagnosis of Endometriosis
16116513|NCT02038972|Genetic|Autologous Stem Cells|The subjects autologous stem cells banked at Cord Blood Registry will be infused intravenously by gravity.
16116514|NCT02038959|Other|Virtual Visits|Virtual visits will be completed using HIPAA-compliant video conferencing software from SBR Health and Vidyo, designed specifically for use in the healthcare industry. The software is available for Windows and Mac OS, as well as iOS devices (iPad and iPhone).
16116515|NCT02038946|Drug|Nivolumab|
16116516|NCT02038933|Drug|Nivolumab|
16116517|NCT02038920|Drug|Vedolizumab|Vedolizumab IV injection
16116518|NCT02038920|Drug|Vedolizumab placebo|Vedolizumab placebo-matching IV infusion
16116520|NCT02038907|Biological|Norovirus Bivalent VLP Vaccine|Norovirus GI.1/GII.4 bivalent VLP vaccine IM injection
16116521|NCT02038894|Drug|Intubated with Sevoflurane (IS)|Anesthesia will be maintained with sevoflurane 3% in oxygen at 2 L/min. The endoscopist will begin the procedure. The sevoflurane inspired concentration will be adjusted between 1 to 2 times the minimum alveolar concentration (MAC) by the attending anesthesiologist to maintain an appropriate level of anesthesia.
16116522|NCT02038894|Drug|Intubated with Propofol (IP)|Anesthetic maintenance will be with 2 L/min flow of oxygen through the endotracheal tube and a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg and an increase in the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist if necessary to provide adequate anesthesia.
16116523|NCT02038894|Drug|Zofran - no intubation|A nasal cannula will be placed with oxygen administered at a rate of 3 L/min, and a bite block will be inserted. Zofran will be administered. Anesthesia will be maintained with a continuous propofol infusion at a rate of 250 mcg/kg/min. A maximum of two bolus doses of propofol 0.5 to 1 mg/kg, and an increase of the continuous infusion to 300 mcg/kg/min may be given at the discretion of the anesthetist.
16116524|NCT02038894|Drug|Propofol|
16116525|NCT02038881|Biological|IMVAMUNE®|0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml
16116526|NCT02038868|Drug|ASP4901|oral
16116527|NCT02038868|Drug|Tamsulosin|oral
16116528|NCT02038868|Drug|Placebo|oral
16116529|NCT02038855|Behavioral|Integrated Intervention for Dual Problems and Early Action|Integrated Intervention for Dual Problems and Early Action (IIDEA) includes psycho-education, Cognitive Behavioral Therapy and mindfulness; identifies triggers and challenging thoughts; provides motivational techniques for reducing substance use and/or smoking cravings; incorporates cognitive restructuring to identify and correct negative thinking patterns influenced by depression, anxiety and/or trauma; and includes self-monitoring of thoughts and risk behaviors that contribute to substance use, smoking and increased HIV risk.
16116530|NCT02038842|Biological|LIPO-5|LIPO-5: 1mL IntraMuscular, 2 shots;
16116531|NCT02038842|Biological|MVA HIV-B (MVATG17401)|MVA HIV-B (MVATG17401): 0.5mL IntraMuscular, 2 shots;
16116532|NCT02038842|Biological|GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots|GTU®-MultiHIV B: 0.5 mL IM via Biojector® 2000 and 0.5mL IntraDermic, 3 shots
16116533|NCT02038829|Drug|Placebo|Placebo
16116534|NCT02038829|Drug|SUN101 3 mcg|SUN-101 3 mcg bid
16116535|NCT02038829|Drug|SUN-101 6.25 mcg|SUN-101 6.25 mcg bid
16116536|NCT02038829|Drug|SUN-101 12.5 mcg|SUN-101 12.5 mcg bid
16116537|NCT02038829|Drug|SUN-101 50 mcg|SUN-101 50 mcg bid
16116538|NCT02038829|Drug|Aclidinium|Aclidinium 400 mcg bid
16116539|NCT02038816|Drug|Deferasirox + Azacitidine|"Deferasirox:
~20 mg/kg/d for < 14ml/kg/mo pRBCs (~ <4U/mo), 30mg/kg/d for ≥14ml/kg/mo pRBCs(≥4U/mo), 10mg/kg/d for transfusion-independent patients"
16116540|NCT02038816|Drug|Azacitidine|Azacitidine 75mg/m2 sc daily X 7 days (5-2-2 schedule permitted) on a 28 day cycle for 6 cycles
16116541|NCT02038790|Drug|Suboxone Sublingual Film|A single Suboxone sublingual film strip containing 8mg buprenorphine and 2mg naloxone taken sublingually on either Day 0 or Day 1, depending on randomized treatment arm assignment. Study drug will be administered by designated qualified study personnel at the site in the morning prior to 9:00 a.m. under fasting conditions.
16116542|NCT02038790|Drug|Zubsolv sublingual tablets|A single Zubsolv sublingual tablet containing 5.7mg buprenorphine and 1.4mg naloxone taken sublingually on either Day 0 or Day 1, depending on randomized treatment arm assignment. Study drug will be administered by designated qualified study personnel at the site in the morning prior to 9:00 a.m. under fasting conditions.
16116543|NCT02038777|Drug|PF-04449913|PF-04449913 administered orally and continuously in 28 day cycles.
16116544|NCT02038777|Drug|PF-04449913|PF-04449913 administered orally and continuously in 28 day cycles.
16116545|NCT02038777|Drug|Low dose ARA-C (LDAC)|Low dose ARA-C (LDAC) administered at 20 mg SQ, BID on Days 1 through 10.
16116546|NCT02038777|Drug|PF-04449913|PF-04449913 administered orally and continuously in 28 day cycles.
16116547|NCT02038777|Drug|Daunorubicin|Daunorubicin given using 60 mg/m2 for 3-days.
16116548|NCT02038777|Drug|Cytarabine|Cytarabine 100 mg/m2 on days 1 through 7.
16116549|NCT02038777|Drug|PF-04449913|PF-04449913 administered orally and continuously in 28 day cycles.
16116550|NCT02038777|Drug|Azacitidine|Azacitidine Combination Cohort; Azacitidine 75 mg/m2 for 7 days.
16116551|NCT02038777|Drug|PF-04449913|PF-04449913 administered orally and continuously in 28 day cycles.
16116552|NCT02038777|Drug|LDAC|Low dose ARA-C (LDAC) administered at 20 mg SQ, BID on Days 1 through 10.
16116553|NCT02038764|Drug|Placebo|Placebo
16116554|NCT02038764|Biological|PF-06342674 Dose A|Multiple SC Doses
16116555|NCT02038764|Biological|PF-06342674 Dose B|Multiple SC Doses
16116556|NCT02038764|Biological|PF-06342674 Dose C|Multiple SC Doses
16116557|NCT02038764|Biological|PF-06342674 Dose D|Multiple SC Doses
16116558|NCT02038738|Drug|68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography.|
16116559|NCT02038712|Dietary Supplement|Fed Condition|Subjects will consume a 600mL 600kcal liquid test meal
16116560|NCT02038712|Dietary Supplement|Fasted condition|Subjects will consume 600mL plain water.
16116561|NCT02038712|Procedure|Blood samples|Blood samples will be collected at -15, 0, 10, 30, 60, 90, 120 min
16116562|NCT02038712|Behavioral|Subjective appetite ratings|Appetite ratings will be collected at -15, 0, 10, 30, 60, 90, 120 min.
16116563|NCT02038712|Procedure|fMRI scan|Blood Oxygen Dependent (BOLD) signal response to pictures and words of food and non-food items will be measured using functional magnetic resonance imaging (fMRI).
16116564|NCT02038699|Drug|ONC201|ONC201 capsules will be administered orally once every three weeks with flat dosing. Dosage will be given according to a modified Fibonacci sequence with the anticipated starting dose being 125 mg.
16116565|NCT02038686|Device|PFN-A|
16116566|NCT02038673|Drug|ASP5878|oral
16116567|NCT02038660|Device|Balloon angioplasty|
16116568|NCT02038647|Drug|Alisertib|Alisertib tablets
16116569|NCT02038647|Drug|Placebo|Placebo matching tablets
16116572|NCT02038634|Device|Ultrasound|Ultrasound guided injection using GE Healthcare LOGIQ e Ultrasound
16116573|NCT02038621|Drug|Paclitaxel|
16116574|NCT02038621|Drug|Oxaliplatin and Capecitabine|Before randomization,all enrolled patients underwent 3 cycles XELOX chemotheray. After patients' disease achieved CR\PR\SD,then randomized into this clinical trial.
16116575|NCT02038608|Device|PET|
16116576|NCT02038595|Radiation|PET imaging|
16116577|NCT02038582|Other|POC CD4 Testing|Point of Care CD4 testing
16116578|NCT02038582|Other|CD4 Referral|Referral to CD4 testing
16116579|NCT02038582|Behavioral|Lay Counselor Follow-up|Follow-up from a lay counselor
16116580|NCT02038582|Behavioral|Clinic Accompaniment|Accompaniment to the clinic by a counselor
16116581|NCT02038582|Behavioral|Clinic Referral|Referral to clinic
16116582|NCT02038582|Behavioral|SMS Reminder|SMS reminder for male circumcision
16116583|NCT02038582|Behavioral|Circumcision Promotion|Promotion of male circumcision at the time of HIV testing
16116584|NCT02038582|Other|POC VL|POC VL testing for HIV infected persons on ART
16116585|NCT02038582|Other|Laboratory based VL assay|Laboratory based viral load testing for HIV infected persons on ART
16116586|NCT02038569|Drug|LEO 80185 gel|
16116587|NCT02038556|Behavioral|cognitive behaviorial therapy -Insomnia|
16116588|NCT02038543|Drug|Hydroxyproline and Leucine|Subjects will be infused with 13C5-hydroxyproline and 2H3-leucine for 6 hrs in the CRTU. The metabolic flux of 2H3-leucine has been well characterized, and is used as a control when studying the metabolism of trace infusions of labeled amino acids 3. Blood samples will be obtained every 30 min to determine the enrichment of plasma with 13C5-hydroxyproline and 2H3-leucine. Urine collections will be obtained hourly. The fluxes of whole body hydroxyproline and leucine will be calculated
16116589|NCT02038491|Procedure|regional anesthesia|Spinal, epidural, combined spinal epidural, nerve blocks
16116590|NCT02038478|Biological|Donor Stem Cell Transplantation|One day after they complete their radiation and Campath-1H treatments and have begun their Sirolimus, the donor blood stem cells described above are transfused through the central line. This process takes approximately 30 minutes to 2 hours and is normally completely without side effects.
16116591|NCT02038465|Device|Questionary|Test the effectiveness of two techniques of cognitive remediation of autobiographical memory using an innovative tool called SenseCam ® for patient
16116592|NCT02038465|Device|Questionary|Test the effectiveness of two techniques of cognitive remediation of autobiographical memory using an innovative tool called SenseCam ® for healthy volunteers
16116593|NCT02038452|Drug|Depo-Medrone|Steroid Injection
16116594|NCT02038452|Device|Wrist Splint|Simple wrist splint
16116595|NCT02038439|Behavioral|Intervention A - Online Clinical Questions Recorder|Clinicians allocated to this intervention will receive access to an online recorder for the clinical questions at the point of care. The recorder is accessible across a wide range of devices including phones, tablets, and desktop computers.
16116596|NCT02038439|Behavioral|Intervention B - Online Evidence Retrieval Coach|Clinicians allocated to this intervention will receive online guidance, embedded in the MPFS search engine, in the form of short videos, animations, demos and tips and tricks regarding evidence retrieval.
16116597|NCT02038439|Behavioral|Intervention C - Online Audit and Feedback|Clinicians allocated to this intervention will receive feedback on their current search performance compared to their peers, both online when using MPFS as well as by e-mail.
16116598|NCT02038426|Biological|BLOOD SAMPLES|
16116599|NCT02038426|Device|Radiographs of the sacroiliac joints|
16116600|NCT02038426|Device|Radiographs of heels|
16116601|NCT02038426|Device|SCAN|
16116602|NCT02038400|Device|KINETUBE medical Device|
16116603|NCT02038400|Device|insertion of tympanic ventilation tubes (tympanostomy)|
16116604|NCT02038387|Behavioral|normocaloric low cholesterol diet|
16116605|NCT02038374|Procedure|biopsies|
16116606|NCT02038361|Genetic|blood draw|
16116607|NCT02038348|Device|PET with 18F-FDOPA|
16116608|NCT02038335|Drug|DMPA|Depot medroxyprogesterone acetate
16116609|NCT02038335|Drug|NET-EN|Norethisterone enantate
16116610|NCT02038335|Drug|MPA/E2|Medroxyprogesterone acetate and estradiol cypionate
16116611|NCT02038335|Device|LNG-I|Levonorgestrel subdermal implant
16116612|NCT02038335|Device|ENG-I|Etonogestrel subdermal implant
16116613|NCT02038335|Device|Cu-IUD|Copper IUD
16116614|NCT02038322|Device|The Stork - Conception Aid|
16116615|NCT02038296|Procedure|transarterial chemoembolization|
16116616|NCT02038257|Procedure|MKTP (melanocyte keratinocyte transplant procedure)|Each subject will have the melanocyte keratinocyte transplant procedure on 4 distinct areas using the two different techniques being studied (carbon dioxide laser and dermabrasion) and the two different dressings being studied (vaseline impregnated gauze and collagen dressing).
16116617|NCT02038257|Device|Collagen Dressing|Each subject will have MKTP on 4 distinct areas. Two of these areas will be dressed with a collagen dressing.
16116618|NCT02038257|Device|Vaseline Impregnated Gauze|Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be dressed with vaseline impregnated gauze.
16116619|NCT02038257|Device|Carbon Dioxide Laser|Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be de-epithelialized using a carbon dioxide laser.
16116620|NCT02038257|Device|Dermabrasion|Each subject will have MKTP on 4 distinct areas of depigmented skin. Two of these areas will be de-epithelialized using dermabrasion.
16116621|NCT02038244|Other|Multimodal integrative medicine inpatient treatment program|
16116622|NCT02038231|Behavioral|Parenting Mindfully Program|see Arm Description.
16116623|NCT02038231|Other|Parent Education Program|See Arm Description.
16116663|NCT02037906|Radiation|Escalating Energy SWL|Dose escalation, 1500 SW at 18 kv, followed by 1500 SW at 20 kv and the following 1500 SW at 22 kv.
16116664|NCT02037906|Radiation|Constant Energy SWL|Constant dose at 20 kv
16116665|NCT02037906|Radiation|Reduction Energy SWL|Dose reduction, 1500 SW at 22 kv, followed by 1500 SW at 20 kv and the following at 18 kv.
16116666|NCT02037893|Drug|Antipyrine and Benzocaine otic solution|antipyrine 54 mg and benzocaine 14 mg
16116945|NCT02036112|Procedure|Individual ELAPE|device
16116624|NCT02038218|Drug|4-Demethyl-4-cholestryloxycarbonylpenclomedine|"This will be an open-label, uncontrolled two-arm, multi-center study in patients with CNS involvement from melanoma, breast, lung cancers or primary malignancies of the CNS. Patients can be previously treated with radiation and systemic therapies and are eligible if they also have other sites of cancer involvement.
~Two Cohorts of patients will be treated every 21 days with a single infusion of DM-CHOC-PEN as an out-patient:
~Cohort 1: Patients with liver involvement or history of disease will be treated at a dose of 85.8 mg/m2 and;
~Cohort 2: Patients without liver involvement or history of liver disease, will be treated at a dose of 98.7 mg/m2.
~Patients in both cohorts will discontinue dosing with DM-CHOC-PEN when there are any unacceptable toxicities, progression of cancer or patient compliance."
16116625|NCT02038192|Behavioral|Living with Hope Program|"The Living with Hope Program is based on the research team's grounded theory study Hope and Connection. The film  Connecting with Hope reflects the findings of the grounded theory study. Stories of the Present has been utilized in the team's previous research with family caregivers of persons with advanced cancer."
16116626|NCT02038192|Behavioral|Stories of the Present|Stories of the Present is a directed journaling activity in which participants write in a journal at the end of the day their challenges, hope and hope for tomorrow
16116627|NCT02038179|Drug|Allopurinol|Participants who received allopurinol as urate lowering therapy, at a daily dose of 300 mg once daily by mouth for a 4 week duration.
16116628|NCT02038179|Drug|Placebo|Participants who received placebo tablet (matching Allopurinol 300 mg) daily by mouth for a 4 week duration.
16116629|NCT02038153|Other|Laboratory Biomarker Analysis|Correlative studies
16116630|NCT02038153|Drug|Lenalidomide|Given PO
16116631|NCT02038140|Device|Zimmer Trabecular Metal Total Ankle System|Primary or revision total ankle replacement
16116632|NCT02038114|Behavioral|Instructed to read patient education pamphlets|The intervention in this study is the administration of patient education pamphlets and instructions to read them. Half of all patients who participate in this study will be required to read pamphlets on symptoms that are relevant to them (i.e. symptoms that they are experiencing). Subsequent to reading pamphlets, patients will complete study questionnaires to assess their impact.
16116633|NCT02038101|Behavioral|Education and Feedback|"Formal Rounds on AUC for TTE
~Appropriate Use for TTE Application for Smartphone
~Individualized Feedback Reports provided by email"
16116634|NCT02038075|Behavioral|Brief Cognitive Behavioral Therapy (BCBT)|
16116635|NCT02038075|Behavioral|Treatment As Usual (TAU)|
16116636|NCT02038062|Procedure|Sevoflurane preconditioning|Preconditioning by transient application of sevoflurane
16116637|NCT02038049|Drug|VAY736|Single intravenous infusion of VAY736 (10 mg/kg)
16116638|NCT02038049|Drug|Placebo|Placebo to VAY736
16116639|NCT02038036|Drug|Best Available Therapy|Best Available Therapy as selected by the investigator from: Hydroxyurea, Pegylated-Interferon (IFN/PEG-IFN), pipobroman, anagrelide, IMIDs, or observation. Participants randomized to BAT who did not respond by Week 28 were eligible to crossover and start treatment with ruxolitinib.
16116640|NCT02038036|Drug|Ruxolitinib|Ruxolitinib was administered at a starting dose of 10 mg twice a day (bid). Dose was adjusted based on efficacy and safety parameters up to a maximum dose of 25 mg bid.
16116641|NCT02038023|Drug|Intravaneous iron(low molecular weight iron dextran)|1000 mg of Iron dextran administered over one hour
16116642|NCT02038010|Drug|PI3K inhibitor BYL719|Given PO
16116643|NCT02038010|Biological|ado-trastuzumab emtansine|Given IV
16116644|NCT02038010|Other|pharmacological study|Correlative studies
16116645|NCT02038010|Other|laboratory biomarker analysis|Optional correlative studies
16116646|NCT02037997|Drug|docetaxel|docetaxel 75mg/m2 ivgtt D1
16116647|NCT02037997|Drug|pemetrexed|pemetrexed 500mg/m2 ivgtt D1
16116648|NCT02037997|Drug|Erlotinib|Erlotinib 150mg qd
16116649|NCT02037984|Biological|Prevnar 13®|Pneumococcal capsular polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 µg each), and 6B (4.4 µg) in each 0.5 mL dose.
16116650|NCT02037984|Biological|V114 1x:1x:1x|V114 1x:1x:1x contains 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 125 µg of Aluminum Phosphate Adjuvant (APA).
16116651|NCT02037984|Biological|V114 2x:2x:2x|V114 2x:2x:2x contains 4.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA.
16116652|NCT02037984|Biological|V114 2x:1x:2x|V114 2x:1x:2x contains 4.0 μg of polysaccharide serotypes 6A, 18C, 19A, 19F, and 23F; 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 7F, 9V, 14, 22F, and 33F; 8.0 μg of polysaccharide serotype 6B; and 250 µg of APA.
16116653|NCT02037984|Biological|V114 1x:1x:2x|V114 1x:1x:2x contains 2.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 4.0 μg of polysaccharide serotype 6B; and 250 µg of APA.
16116654|NCT02037984|Biological|V114 0.5x:0.5x:2x|V114 0.5x:0.5x:2x contains 1.0 μg of polysaccharide serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, and 33F; 2.0 μg of polysaccharide serotype 6B; and 250 µg of APA.
16116655|NCT02037971|Procedure|Aerobic Exercise|From 1st week up to and including 4th week, subjects will do: 5 minutes warm-up, then 15-30 minutes low to moderate (55-65% VO2) exercise, then 15 minutes stretching. From 5th week up to and including 16th week, subjects will do: 5 minutes warm-up, then intermittent training for between 30-40 minutes, then 10 minutes stretching.
16116656|NCT02037971|Other|Control Group|The control group will have monthly meetings to learn about: good sleep habits, Systemic Lupus Erythematosus (their disease) and general good health.
16116657|NCT02037958|Device|Laryngeal Mask Airway-Supreme|Patients who receive the LMA-S
16116658|NCT02037958|Device|Endotracheal Tube|Patients who receive endotracheal intubation
16116659|NCT02037945|Procedure|18F-FCH PET Scan|
16116660|NCT02037932|Device|Balloon Assisted Coiling using MicroVention second-generation hydrogel coils and MicroVention Scepter Occlusion Balloon Catheter.|Balloon Assisted Coiling using MicroVention second-generation hydrogel coils and MicroVention Scepter Occlusion Balloon Catheter.
16116661|NCT02037919|Other|Immediate Nexplanon Insertion|Patient will have a Nexplanon inserted within 15 minutes of her abortion
16116662|NCT02037919|Other|Post-op Nexplanon Insertion|Place Nexplanon at post operative visit rather than at surgery
16116784|NCT02037074|Drug|Placebo|Arm 4
16116667|NCT02037893|Drug|Antipyrine Otic Solution|Antipyrine 54 mg and glycerine dehydrated to 1.0 mL
16116668|NCT02037893|Drug|Benzocaine Otic Solution|benzocaine 14 mg and glycerine dehydrated to 1.0 mL
16116669|NCT02037893|Drug|Placebo Otic solution|Placebo otic solution will be glycerin that is dehydrated
16116670|NCT02037880|Procedure|Lumbar puncture|
16116671|NCT02037880|Device|Magnetic Resonance Imaging (MRI) of the brain|
16116672|NCT02037867|Device|Fibrosis Biomarkers|Liver disease stratification with liver stiffness scan (Transient Elastography) Analysis of diagnostic performance of serum fibrosis markers (as listed above) Whole blood samples obtained for DNA analysis
16116673|NCT02037854|Other|Nutrient formulation|
16116674|NCT02037841|Other|Nursing-driven clinical pathway for management of inpatient asthma|
16116675|NCT02037815|Drug|20% mannitol solution, 125 ml, IV infusion in 15 min|
16116676|NCT02037815|Drug|3.1% sodium chloride solution, 125 ml, IV infusion in 15 min|
16116677|NCT02037802|Device|B-Braun, Perifix® ONE Paed, Germany|caudal epidural catheterization bupivacaine fentanyl
16116678|NCT02037802|Drug|Pethidine|pethidine intravenous at a dose 1mg/kg when pain score more than 5 postoperative rescue analgesia
16116679|NCT02037802|Drug|Propofol|fentanyl propofol atracurium besylate
16116680|NCT02037802|Drug|Bupivacaine|
16116681|NCT02037802|Drug|Fentanyl|
16116682|NCT02037776|Drug|Rikkunshito|- Oral administration of rikkunshito (2.5 g t.i.d) before meals for 8 weeks
16116683|NCT02037776|Drug|Rikkunshito placebo|- Oral administration of rikkunshito placebo (2.5 g t.i.d) before meals for 8 weeks
16116684|NCT02037750|Behavioral|LINKS|"In the LINKS, foster/kin parents will participate in weekly group meetings led by well-trained and supervised paraprofessional facilitators (school behavioral aids and foster parents) where the curriculum is based on parent management training (PMT). In previous studies, attendance at such groups has been high, averaging about 75-80%. Missed sessions will be made up with an in-person visit to the foster/kin home during the week of the original session. In addition, youth in the intervention condition will receive individual skill building sessions from a Life Skills Coach to increase their competency at goal setting, refusal skills, and peer relations."
16116685|NCT02037737|Drug|Abatacept|
16116686|NCT02037724|Dietary Supplement|supplement containing 60 mg iron sulfate|control agent
16116687|NCT02037724|Dietary Supplement|iron rich food supplement (60 mg iron)|contains 60 mg of iron
16116688|NCT02037724|Dietary Supplement|iron rich food supplement (10 mg iron)|contains 10 mg iron
16116689|NCT02037724|Dietary Supplement|supplement containing 10 mg iron sulfate|control agent
16116690|NCT02037711|Drug|Levobupivacaine 0.5%|Group I (Chirocaine group) (n=20): Levobupivacaine 0.5% will be instilled during insufflations of CO2 at the beginning of surgery at a dose of 2mg/kg.
16116691|NCT02037711|Drug|Normal saline|Group II (control group) (n=20): laparoscopy done with instillation of normal saline instead of levobupivacain
16116692|NCT02037698|Device|Pre-PCI coronary CT scan|Coronary CT scan before CTO PCI
16116693|NCT02037685|Behavioral|Motivational Interviewing (MINT)|"MINT has the following basic structure and goals:
~Establishing a connection and reinforcing autonomy: open ended questions regarding the health status or well being of the participant to establish an empathetic connection with the subject via reflective listening.
~Empathizing with ambivalence and rolling with resistance. The counselor will help the subject express the ambivalence they may have regarding taking their statins.
~Coach the subject towards expressions of commitment. Commitment is predictive of change. Speaking commitment out loud to an other enhances the likelihood that the commitment will be acted upon"
16116694|NCT02037685|Other|Usual Care|We selected American Heart Association brochures on a variety of risk factors, including dyslipidemia and mailed them to subjects in the usual care.
16116695|NCT02037672|Drug|metformin|
16116696|NCT02037672|Drug|metformin and roflumilast|
16116697|NCT02037659|Procedure|DermaBond treatment of Gastric Varices|Endoscopic Ultrasound (EUS) administration of DermaBond glue to control bleeding gastric varices.
16116698|NCT02037646|Other|Qualitative fecal immunochemical test|This test measures the amount of blood within the submitted stool specimen
16116699|NCT02037646|Other|Quantitative fecal immunochemical test|This test detects presence or absence of blood within a submitted stool specimen.
16116700|NCT02037646|Procedure|Colonoscopy|Patients with positive tests will be subjected to colonoscopy to determine presence or absence of advanced colorectal neoplasms.
16116701|NCT02037646|Other|Cost analysis|Data on direct and indirect costs to patient and institution will be collected at each patient visit related to screening.
16116702|NCT02037646|Other|Anxiety scores|Hospital Anxiety and Depression Scale (HADS) questionnaire
16116703|NCT02037646|Other|Patient satisfaction scores|A 5-point patient satisfaction score will be documented at each patient visit related to screening.
16116704|NCT02037633|Drug|Fentanyl|Fentanyl IV
16116705|NCT02037633|Procedure|Fascia iliaca compartment block|Fascia iliaca compartment block using ropivacaine
16116706|NCT02037633|Drug|ropivacaine|
16116707|NCT02037620|Device|5-6-5 Specify electrode|
16116708|NCT02037620|Device|Restore Advance Pulse Generator|
16116709|NCT02037594|Behavioral|Sexual Health Counseling|This brief intervention presents PrEP within the context of a patient's comprehensive sexual health plan and is designed to enhance decision-making around PrEP use and decrease sexual risk taking.
16116710|NCT02037594|Behavioral|Enhanced Adherence Intervention|This brief intervention is provides standard of care PrEP adherence information plus specific counseling, troubleshooting, and support.
16116711|NCT02037594|Behavioral|PrEP Information (Active Control)|Standard of Care Information about PrEP
16116712|NCT02037594|Behavioral|Standard of Care Adherence Support (Active Control)|Standard of care information and instruction about PrEP adherence.
16116713|NCT02037581|Behavioral|Early detection and Integrated Care|Patients receive integrated care including therapeutic Assertive Community Treatment (TACT)
16116714|NCT02037581|Behavioral|Standard Care|Standard care as being offered by private psychiatrists
16116785|NCT02037061|Drug|Bupivacaine|Intraoperatively the patient will receive 10ml of bupivacaine injected into the sacrospinous ligament.
16116786|NCT02037061|Other|Normal Saline|
16116787|NCT02037048|Drug|oxaliplatin|Given IV
16116715|NCT02037568|Behavioral|fPER|"Briefly in order, the sessions will include: 1) Overview and introduction to stress management, 2) Stress and the mind-body connection, 3) How our thoughts can lead to stress, 4) Coping with stress, 5) Strategies for maintaining energy and stamina, 6) Coping with uncertainty and fear of unknown, 7) Managing changing relationships/communicating needs, and 8) Getting the support they need, modeled after a successful intervention for patient groups. Manualization is crucial for successful wider implementation. Sessions 9 and 10 will provide booster sessions in which the interventionist will assess current challenges for the caregiver, provide review, and emphasize further coping skills training that might assist the caregiver in managing current stressors such as coping with the new normal."
16116716|NCT02037555|Biological|AT-III (Human)|AT-III (Human) is an antithrombin concentrate prepared from pooled human plasma. AT-III (Human) is provided as a freeze-dried preparation for intravenous use. The AT-III (Human) preparation is reconstituted in 10 or 20 mL of sterile water for injection prior to intravenous administration.
16116717|NCT02037555|Other|Placebo|0.9% Sodium Chloride for Injection, United States Pharmacopeia
16116718|NCT02037542|Behavioral|Diet and exercise|Upon enrollment, the patient will be asked to meet with a dietitian to assess the individual patient's current diet and exercise routines. In the first session, the dietitian will provide individual counseling and together with the patient devise weight loss / exercise strategies that fit the patients' lifestyle. Following the initial assessment, patients will embark on a weekly program, with weekly meetings lasting 30min - 1h. Patients will be asked to record meal portions weekly in a Food Log (Appendix B), according to the established goal. At each meeting, the dietitian will review the Food Log with the patient and evaluate progress.
16116719|NCT02037529|Drug|Eribulin Mesylate|Given IV
16116720|NCT02037529|Other|Laboratory Biomarker Analysis|Correlative studies
16116721|NCT02037529|Drug|Paclitaxel|Given IV
16116722|NCT02037529|Other|Quality-of-Life Assessment|Ancillary studies
16116723|NCT02037516|Device|Accelomyography|quantitative measurement of the train-of-four with the TOF Watch to determine timing of administration of neostigmine and extubation To assure patient flow the time to reversal administration will be limited to approximately 30 minutes after achieving 4 twitches in qualitative monitoring
16116724|NCT02037516|Drug|Neostigmine|Neostigmine is used to reverse the effects of neuromuscular blocking agents
16116725|NCT02037516|Device|Qualitative Monitor|Qualitative (tactile or visual) assessment of residual neuromuscular paralysis
16116726|NCT02037503|Drug|Ketamine|
16116727|NCT02037503|Drug|Saline|
16116728|NCT02037490|Behavioral|Grow2Gether|"Participants in this intervention will:
~Participate in Facebook group of 6-12 peers for about 8 months, led by a professional group mentor.
~Complete an intervention video activity approximately weekly:
~View educational videos addressing topics related to healthy infant growth
~Create photos/videos modeling healthy behaviors and post them to the group
~Provide and receive feedback on posts
~Be encouraged to share information with key caregivers of their child
~Attend group party soon after enrollment, to meet peers and group leader in person."
16116729|NCT02037477|Drug|Vonoprazan|Vonoprazan tablets
16116730|NCT02037477|Drug|Esomeprazole|Esomeprazole capsules
16116731|NCT02037477|Drug|Rabeprazole sodium|Rabeprazole sodium tablets
16116732|NCT02037464|Dietary Supplement|Capsaicin Supplement (Cayenne by Nature's Way)|One capsule of the supplement to be taken twice daily.
16116733|NCT02037451|Procedure|rhythmic auditory stimulation|Participants perform the finger tapping at the same time give rhythmic auditory stimulation ,and need to execute tapping with auditory stimulation.
16116734|NCT02037438|Other|CONV care for the diagnosis and treatment of sleep disorders|The Conventional (CONV) intervention utilized standard-of-care diagnostic and treatment procedures for new patients with sleep disorders at the Stanford Sleep Medicine Center
16116735|NCT02037438|Other|PCCM for the diagnosis and treatment of sleep disorders|The Patient-Centered Outcomes and Coordinated Care Management (PCCM) intervention implemented new methodologies for the diagnosis and treatment of sleep disorders. It also incorporates the utilization of a web-based interactive portal that provides specific and relevant information and resources for patients, health care providers, and allied health professionals. The portal was designed to facilitate informed health care decisions among patients and health care providers through improved access to medical data and enhanced communications.
16116736|NCT02037425|Drug|onabotulinumtoxinA|BOTOX® (Formulation Number 9060X) contains 200 International Units (IU) of Clostridium botulinum Toxin Type A, reconstituted with 4 cc of normal saline providing 5 units per 0.1 cc. At visit 2, subjects will receive their first treatment at Day 29 (+/-3 days). All subjects will receive 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas. Injections will be repeated at day 113 (+/- 3 days) and at day 197 (+/- 3 days).
16116737|NCT02037412|Drug|Ticagrelor|Ticagrelor - 180 mg loading and 90 mg bid maintenance for 3 months
16116738|NCT02037412|Drug|Clopidogrel|Clopidogrel - 600 mg loading and 75 mg qd maintenance for 3 months
16116739|NCT02037399|Drug|intravenous dexamethasone|"Patients were enrolled in outpatient settings after evaluating appropriate ESD indications. A single study coordinator performed a randomization process by using a table of random numbers. The patients were allocated to receive intravenous dexamethasone (0.15 mg/kg) immediately after ESD. The patients with an odd number were assigned into DEXA group, and the patients with an even number were assigned into placebo group. The syringe including dexamethasone was completely covered with a paper sticker to mask treatment assignment. The operator and assisting nurse were also blinded to the study.
~At the day and next day of ESD, intravenous proton pump inhibitor was routinely administered to prevent complications including bleeding. At 3rd day of ESD, all patients started to take 40mg oral lansoprazole once a day and sucralfate suspension 3 times a day for 28 days."
16116788|NCT02037048|Drug|leucovorin calcium|Given IV
16116789|NCT02037048|Drug|fluorouracil|Given IV
16116790|NCT02037048|Procedure|therapeutic conventional surgery|Undergo therapeutic conventional surgery
16116791|NCT02037048|Radiation|radiation therapy|Undergo radiation therapy
16116792|NCT02037048|Drug|carboplatin|Given IV
16116793|NCT02037048|Drug|paclitaxel|Given IV
16116794|NCT02037035|Drug|Ketamine|
16116795|NCT02037022|Behavioral|Pivotal Response Treatment Package (PRT-P)|
16116796|NCT02037009|Other|Health care organization (anesthetic surveillance)|
16116740|NCT02037399|Drug|intravenous normal saline|"Patients were enrolled in outpatient settings after evaluating appropriate ESD indications. A single study coordinator performed a randomization process by using a table of random numbers. The patients were allocated to receive intravenous normal saline as placebo immediately after ESD. The patients with an odd number were assigned into DEXA group, and the patients with an even number were assigned into placebo group. The syringe including placebo was completely covered with a paper sticker to mask treatment assignment. The operator and assisting nurse were also blinded to the study.
~At the day and next day of ESD, intravenous proton pump inhibitor was routinely administered to prevent complications including bleeding. At 3rd day of ESD, all patients started to take 40mg oral lansoprazole once a day and sucralfate suspension 3 times a day for 28 days."
16116741|NCT02037386|Device|H-side branch stent|Implantation of H-side branch stent at coronary bifurcation stenotic lesion
16116742|NCT02037373|Biological|Octaplas™|Octaplas™ infusion solution for IV administration as prescribed by the treating physician.
16116743|NCT02037373|Biological|Plasma|Plasma as prescribed by the treating physician.
16116744|NCT02037360|Behavioral|Active Comparator App/Training|This is a free smoking cessation smartphone app using the latest evidence-based smoking cessation methods and behavior change theory. The app allows users to set a quit date, financial goals, and reminders, track daily smoking habits with an easy-to-use calendar, see graphs tracking money saved and number of packs not smoked, receive health milestones and craving tips to stay motivated, connect with social networks to give milestone updates, create a video diary, and watch personalized video messages from loved ones
16116745|NCT02037360|Behavioral|Experimental App/Training|It is comprised of twenty-two modules of 10-15 minutes each, designed to teach mindfulness for smoking cessation using psychoeducation-based audio and videos, animations to reinforce key concepts, and in vivo exercises. In addition, 5 bonus modules become available upon completion of earlier modules; these may be accessed for additional practices to bolster other modules.
16116746|NCT02037347|Drug|Palifermin|
16116747|NCT02037334|Device|Pregnolia System|No intervention is done except for measuring the stiffness of the cervix in pregnant women
16116748|NCT02037308|Dietary Supplement|Bread|
16116749|NCT02037295|Drug|Vancomycin|Vancomycin 125mg orally four times per day for 12 days
16116750|NCT02037295|Drug|Placebo oral tablet|Placebo pills orally four times per day for 12 days
16116751|NCT02037295|Other|Overfeeding diet (OF)|Diet in which the calories are 150% of their weight maintaining energy requirements
16116752|NCT02037295|Other|Underfeeding diet (UF)|Diet in which the calories are 50% of their weight maintaining energy requirements
16116753|NCT02037282|Drug|Anti-influenza IVIG|
16116754|NCT02037256|Drug|bortezomib|Given IV
16116755|NCT02037256|Biological|filgrastim|Given SC
16116756|NCT02037256|Procedure|autologous hematopoietic stem cell transplantation|Undergo autologous hematopoietic stem cell transplantation
16116757|NCT02037243|Behavioral|Standard Public Health Intervention with Water Treatment|Compound level meeting
16116758|NCT02037243|Behavioral|Standard Public Health Intervention with Water Treatment & Hand Washing|Compound level meeting
16116759|NCT02037243|Behavioral|Disgust and Shame Based Intervention with Water Treatment|Compound level meeting
16116760|NCT02037243|Behavioral|Disgust and Shame Based Intervention with Water Treatment & Hand Washing|Compound level meeting
16116761|NCT02037230|Drug|MK-1775|MK-1775 will be given as an oral capsule on days 1 and 2, and on days 8 and 9 of every 3-week cycle .
16116762|NCT02037230|Drug|Gemcitabine|Gemcitabine 1000mg/m2 will be infused over 30 minutes on days 1 and 8 of a 3 -week treatment cycle.
16116763|NCT02037230|Radiation|Radiation Therapy|52.5Gy in 25 fractions (2.1Gy/fraction), using intensity modulated radiation therapy (IMRT). Radiation therapy will be administered after chemotherapy.
16116764|NCT02037217|Device|ExAblate Transcranial MRgFUS System|
16116765|NCT02037204|Other|Cartilage repair surgery|Single-stage surgery, After debridement, the cartilage defect is filled with the fibrin glue carrier containing autologous chondrons and allogeneic MSCs
16116766|NCT02037191|Drug|Methotrexate|"Non responder patients in arm A will be re-randomized to receive from month 6 to the end of the study (month 12):
~methotrexate alone or methotrexate associated with prednisone 0.3 mg/Kg/day"
16116767|NCT02037191|Drug|Placebo|"Non responder patients in arm B will be re-randomized to receive from month 6 to the end of the study (month 12):
~methotrexate alone or methotrexate associated with prednisone 0.3 mg/Kg/day"
16116768|NCT02037178|Other|First ultrasound reading|First ultrasound reading of the sub-renal abdominal aorta by a general practitioner.
16116769|NCT02037178|Other|Second ultrasound interpretation|The untrasound images recorded by general practitioners will be interpreted a second time by an expert in vascular medecine, and evaluated for their image quality.
16116770|NCT02037165|Drug|Placebo to BI 1026706|Placebo tablet
16116771|NCT02037165|Drug|Pregabalin|Pregabalin hard capsule
16116772|NCT02037165|Drug|BI 1026706|BI 1026706 oral solution
16116773|NCT02037165|Drug|Celecoxib|Celecoxib hard capsule
16116774|NCT02037152|Behavioral|Body scan exercise|"The body scan includes 20 minutes of guided audio-- the pre-recorded voice of a narrator instructs the user to systematically direct attention to various parts of the body. The audio content is adapted from the body scan exercises traditionally taught in evidence-based mindfulness interventions."
16116775|NCT02037139|Other|Screening|Standard care screening
16116776|NCT02037139|Other|Brochure|Participants are given an illustrated educational brochure
16116777|NCT02037139|Behavioral|Education|Participants undergo a in-person educational intervention
16116778|NCT02037126|Drug|Psilocybin|this has been used in treating obsessive-compulsive disorders, cluster headaches, anxiety, and drug dependence.
16116779|NCT02037126|Drug|Diphenhydramine|This drug will be used as the control. Diphenhydramine is a histamine blocker.
16116780|NCT02037087|Behavioral|Good household prenatal practice|Knowledge on nutrition, labor, non-medical pain management, breastfeeding and depression
16116781|NCT02037087|Behavioral|Care seeking|"Danger-sign recognition
~Reminders for government projects"
16116782|NCT02037087|Behavioral|Full bank of SMS|"Danger-sign recognition
~Reminders for government projects
~Knowledge on nutrition, labor, non-medical pain management, breastfeeding and depression"
16116783|NCT02037074|Drug|Drug: EVP-6308|Arms 1, 2, 3
16116797|NCT02036983|Procedure|Transversus abdominis plane block (TAP BLOCK)|Ultrasound guided TAP block with local anesthetics and dexamethasone.
16116798|NCT02036983|Procedure|Instillation of surgical site with local anesthetic.|Instillation of surgical site with local anesthetics and dexamethasone.
16116799|NCT02036983|Procedure|Opioid IV medications (Control)|Standard anesthetic technique.
16116800|NCT02036970|Drug|Bardoxolone methyl|
16116801|NCT02036970|Drug|Placebo|
16116802|NCT02036957|Procedure|BALM ARM|The product will be applied throughout the body in abundant quantity to achieve that the skin be perfectly hydrated. The product will be applied twice a day (after showering in the morning and at night), massaging the area until completely absorption. Treatment will last three months, and at this time, We will measure toxicologic toxicity in both arms.
16116803|NCT02036957|Procedure|PLACEBO ARM|The product will be applied throughout the body in abundant quantity to achieve that the skin be perfectly hydrated. The product will be applied twice a day (after showering in the morning and at night), massaging the area until completely absorption. Treatment will last three months, and at this time, We will measure toxicologic toxicity in both arms.
16116804|NCT02036931|Device|Metal on Polyethylene articulation|G7 Acetabular Cup System with Metal head on Polyethylene liner articulation (MOP)
16116805|NCT02036931|Drug|Ceramic on Polyethylene articulation|G7 Acetabular Cup System with Ceramic head on Polyethylene liner articulation (COP)
16116806|NCT02036931|Device|Ceramic on Ceramic articulation|G7 Acetabular Cup System with Ceramic head on Ceramic linear articulation (COC) - Outside the United States ONLY
16116807|NCT02036918|Drug|Sipuleucel-T|
16116808|NCT02036918|Procedure|Lymph Node Biopsy|
16116809|NCT02036905|Other|Cervical and thoracic mobilization|Described in arm description
16116810|NCT02036905|Other|cervical and thoracic manipulation|described in arm description
16116811|NCT02036892|Behavioral|Lifestyle counseling with smartphone|Lifestyle counseling with health promoting smartphone software
16116812|NCT02036892|Behavioral|Lifestyle counseling|Lifestyle counseling
16116813|NCT02036879|Drug|Loestrin (norethindrone acetate and ethinyl estradiol)|This is an optional substudy that females participating in the main study can choose to participate in. Loestrin, an oral contraceptive or birth control pill, will be prescribed and taken daily for approximately 2 months.
16116814|NCT02036866|Other|Transcutaneous Electrical Nerve Stimulation|The TENS electrodes will be applied on the medial and lateral superior, as well as the medial and lateral inferior, borders of the patella. A continuous biphasic pulsatile current (150 Hz, phase duration 150 µs) will be applied at an intensity that produces a comfortable sensation but not a muscle contraction. The duration of intervention will be 8 hours per day for 1 week.
16116815|NCT02036866|Other|Physical Therapy Exercises|Patients will be given detailed verbal and hands-on instruction in a home exercise program. This program will consist of 6 exercises modeled from established protocols focuses on improving lower extremity strength. Patients will be instructed to do the exercises daily and to progress the exercises over the week for a maximum of 30 repetitions per day for 1 week.
16116816|NCT02036866|Other|No Intervention|Patients will be instructed to maintain their usual activity level.
16116817|NCT02036853|Drug|Triheptanoin|"Schedule A: Subjects previously treated with triheptanoin will continue to dose at approximately 35% of total daily calories (~1-4g/kg/day, depending on age).
~Schedule B: Subjects who are naïve to triheptanoin will begin a 2-week fixed titration schedule up until they have reached 35% of total daily calories (~1-4 g/kg/day depending on age). If a subject has not reached the target of 35% of total daily calories, by the end of the 2-week fixed titration period, dose titration should continue until achieved or until the maximally tolerated dose has been established."
16116818|NCT02036840|Drug|Antibiotic|
16116819|NCT02036827|Drug|Rocuronium|We will administrate neuromuscular blocking agent until moderate or deep neuromuscular blockade stabilized.
16116820|NCT02036814|Behavioral|Program Health Education|
16116821|NCT02036801|Other|Lung specific elastance|Measurement of lung specific elastance and lung mechanical characteristics at different PEEP levels and tidal volumes
16116822|NCT02036788|Other|Occlusion test|Occlusion test to assess the correct positioning of esophageal balloon catheter when the patient is breathing spontaneously.
16116823|NCT02036788|Other|Thoraco-abdominal compressions|Thoraco-abdominal compressions to assess the correct positioning of esophageal balloon catheter when the patient is sedated and paralyzed.
16116824|NCT02036775|Drug|Lasolvan tablet|One Lasolvan tablet 30 mg twice daily for 5 days.
16116825|NCT02036775|Drug|Lasolvan tablet|One Lasolvan tablet 30 mg twice daily for 5 days.
16116826|NCT02036775|Drug|Lasolvan tablet|One Lasolvan tablet 30 mg twice daily for 5 days.
16116827|NCT02036775|Drug|Lasolvan tablet|One Lasolvan tablet 30 mg twice daily for 5 days.
16116828|NCT02036775|Drug|Lasolvan effervescent tablet|One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.
16116829|NCT02036775|Drug|Lasolvan effervescent tablet|One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.
16116830|NCT02036775|Drug|Lasolvan effervescent tablet|One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.
16116831|NCT02036775|Drug|Lasolvan prolonged-release hard capsule|One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days
16116832|NCT02036775|Drug|Lasolvan prolonged-release hard capsule|One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days
16116833|NCT02036775|Drug|Lasolvan prolonged-released capsules|One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days
16116834|NCT02036775|Drug|Lasolvan tablet|One Lasolvan tablet 30 mg twice daily for 5 days.
16116835|NCT02036775|Drug|Lasolvan tablet|One Lasolvan tablet 30 mg twice daily for 5 days.
16116836|NCT02036775|Drug|Lasolvan prolonged-release hard capsule|One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days
16116837|NCT02036775|Drug|Lasolvan effervescent tablet|One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.
16116838|NCT02036775|Drug|Lasolvan prolonged-release hard capsule|One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days
16116839|NCT02036775|Drug|Lasolvan prolonged-release hard capsule|One Lasolvan prolonged-release hard capsule 75 mg once daily for 5 days
16116840|NCT02036775|Drug|Lasolvan effervescent tablet|One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.
16116898|NCT02036463|Drug|Placebo|
16116841|NCT02036775|Drug|Lasolvan effervescent tablet|One-half Lasolvan effervescent tablet 60mg twice daily for 5 days.
16116842|NCT02036762|Other|Stretching Exercises|The group submitted to stretching exercises in the respiratory muscles and treadmill exercises
16116843|NCT02036749|Procedure|nerve block|quadratus lumborum block
16116844|NCT02036736|Drug|Intraoperative anesthetic strategy by Propofol|"1- Arm Propofol: Propofol TCI induction target between 2 and 6 mg / mL
~Sufentanil (0.15 mg / kg intravenously (IV))
~Atracurium (0.5 mg / kg IV) Maintenance mode by Propofol TCI target between 2 and 4 micrograms / mL tune to 40 <BIS <60 Sufentanil bolus according to intraoperative analgesia Atracurium bolus according to the level of neuromuscular blockade"
16116845|NCT02036736|Drug|Intraoperative anesthetic strategy by Desflurane|"2- Arm Desflurane Desflurane induction (2-3 mg / kg)
~Sufentanil (0.15 mg / kg IV)
~Atracurium (0.5 mg / kg IV)) Desflurane closed by maintenance target with minimal alveolar concentration (MAC) to adapt the circuit to obtain a figure 40 <BIS <60 Sufentanil bolus according to intraoperative analgesia Atracurium bolus according to the level of neuromuscular blockade"
16116846|NCT02036723|Drug|Bevacizumab|Patients will receive bevacizumab at a dose 1.25 mg (in 0.05 ml of solution) as an intravitreal injection on day 1 and then every 28 days during 12 months.
16116847|NCT02036723|Drug|Ranibizumab|Patients will receive ranibizumab at a dose 0.50 mg (in 0.05 ml of solution) as an intravitreal injection on day 1 and then every 28 days during 12 months.
16116848|NCT02036697|Drug|Bupivacaine 4.5|Bupivacaine hyperbaric, 4.5 mg
16116849|NCT02036697|Drug|Bupivacaine 9|Bupivacaine hyperbaric, 9 mg
16116850|NCT02036697|Drug|Morphine|morphine 150 mcg.
16116851|NCT02036697|Drug|Fentanyl|15 mcg
16116852|NCT02036684|Behavioral|Prehabilitation (PREHAB)|
16116853|NCT02036671|Device|The FLEX System will be used to percutaneously create a fistula in CKD patients who require hemodialysis vascular access|
16116854|NCT02036658|Behavioral|Cognitive Behavioral Group Therapy|Cognitive Behavioral Group Therapy for social anxiety disorder is a 12-week treatment that involves psychoeducation, cognitive restructuring and exposure to social situations.
16116855|NCT02036658|Behavioral|Mindfulness-Based Stress Reduction|Mindfulness-Based Stress Reduction will be completed in 12 weeks in the study and includes enhancing one's awareness non-judgmentally by focusing on the present moment through the use of mindfulness meditation.
16116856|NCT02036645|Biological|MEDI1814 for IV injection|Monoclonal antibody for IV Injection
16116857|NCT02036645|Biological|MEDI1814 for Subcutaneous Injection|Monoclonal antibody for subcutaneous injection
16116858|NCT02036645|Biological|IV Placebo|Placebo for IV injection
16116859|NCT02036645|Biological|Placebo for Subcutaneous Injection|Subcutaneous Placebo Injection
16116860|NCT02036632|Device|Eye Patching|
16116861|NCT02036606|Behavioral|questionary|
16116862|NCT02036593|Behavioral|Walk Your Heart to Health|Walking group sessions conducted 3 times per week for 32 weeks.
16116863|NCT02036580|Biological|tralokinumab cohort 1|Tralokinumab is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor
16116864|NCT02036580|Biological|tralokinumab cohort 2|Tralokinumab is a human recombinant monoclonal antibody (MAb) of the subclass that specifically binds human IL-13, blocking interactions with the IL-13 receptor
16116865|NCT02036580|Other|Placebo|
16116866|NCT02036554|Drug|Everolimus|Decrease the level of Tacrolimus and add on Everolimus instead of Mycophenolic acid which is standard treatment.
16116867|NCT02036554|Drug|Tacrolimus|Decrease the level of Tacrolimus and add on Everolimus instead of Mycophenolic acid which is standard treatment.
16116868|NCT02036554|Drug|Mycophenolic acid|Decrease the level of Tacrolimus and add on Everolimus instead of Mycophenolic acid which is standard treatment.
16116869|NCT02036541|Device|AqueSys XEN 45 Glaucoma Implant|Placement of the AqueSys XEN 45 Glaucoma Implant in the study eye
16116870|NCT02036528|Drug|Gentamicin Topical Gel|
16116871|NCT02036528|Drug|Ciprofloxacin|
16116872|NCT02036528|Drug|Doxycycline|
16116873|NCT02036515|Drug|Ertugliflozin 5 mg|Ertugliflozin, oral, 5 mg tablet once daily for 52 weeks
16116874|NCT02036515|Drug|Ertugliflozin 15 mg|Ertugliflozin, oral, 5 mg and 10 mg tablet once daily for 52 weeks
16116875|NCT02036515|Drug|Placebo for ertugliflozin 5 mg|Matching placebo for ertugliflozin 5 mg, oral, once daily for 52 weeks
16116876|NCT02036515|Drug|Metformin|Participants are to remain on their stable doses of metformin (oral, >=1500 mg/day) while receiving blinded investigational product during the double-blind treatment period.
16116877|NCT02036515|Drug|Sitagliptin|Participants are to remain on their stable doses of sitagliptin (oral, 100 mg once daily) while receiving blinded investigational product during the double-blind treatment period.
16116878|NCT02036515|Drug|Glimepiride|Glimepiride rescue medication, oral, once daily, open-label glimepiride; dose determined per the investigator's discretion
16116879|NCT02036515|Biological|Insulin|Insulin glargine rescue medication, injectable, as required. In the event that an investigator considers use of glimepiride to not be appropriate for a participant meeting protocol specified glycemic rescue criteria, insulin glargine can be initiated as the rescue medication, and managed by the investigator according to clinical practice guidelines of the local country.
16116880|NCT02036515|Drug|Placebo for ertugliflozin 10 mg|Matching placebo for ertugliflozin 10 mg, oral, once daily for 52 weeks
16116881|NCT02036502|Biological|Pembrolizumab|Intravenous (IV) infusion
16116882|NCT02036502|Drug|Lenalidomide|Oral capsule
16116883|NCT02036502|Drug|Dexamethasone|Oral tablet IV infusion
16116884|NCT02036502|Drug|Carfilzomib|IV infusion
16116885|NCT02036489|Drug|Vincristine|
16116886|NCT02036489|Drug|Daunorubicin|
16116887|NCT02036489|Drug|Prednisone|
16116888|NCT02036489|Drug|L-asparaginase|
16116889|NCT02036489|Drug|Ciclophosphamide|
16116890|NCT02036489|Drug|Metotrexate|
16116891|NCT02036489|Drug|ARA-C|
16116892|NCT02036489|Drug|Hidrocortisone|
16116893|NCT02036489|Drug|Mercaptopurine|
16116894|NCT02036489|Drug|VP-16|
16116895|NCT02036489|Drug|Dexametasone|
16116896|NCT02036476|Drug|Cabozantinib|Cabozantinib 60 mg Oral Daily 28 days (4 weeks)
16116897|NCT02036463|Drug|Prednisone|
16116899|NCT02036450|Device|Implantable loop recorder (Medtronic Reveal LINQ(TM))|The patients in the experimental arm receive an implantable loop recorder (Medtronic Reveal LINQ(TM)) with continuous monitoring, and are followed by daily automated remote transmissions. New arrhythmia episodes are reviewed daily by an experienced medical doctor. If AF lasting ≥6 minutes is detected and confirmed by at least two senior cardiologists, OAC is initiated. Decision about specific type of OAC, and possible further clinical work-up or treatment, is left to the treating physician and the patient. The remote monitoring continues until end of service of the device, patient withdrawal or other end-of-study.
16116900|NCT02036437|Drug|Misotac® Sigma Pharmaceutical Industries|The solution will be orally administrated every two hours (maximum 12 hours) until adequate uterine contractions obtained (3 per 10 minutes each lasting 40-60 seconds) and then stopped. The initial dose of 20 ml (20 ug) will be increased to 40 ml (40ug) after two doses if there are no contractions. The timing and strength of contractions will be assessed by abdominal palpation. If the contractions are inadequate, augmentation of the active phase of labor will be attempted by hourly-titrated oral misoprostol (20 ml) +/- amniotomy. If the uterine contractions are judged to be adequate, the next dose of misoprostol will be omitted.
16116901|NCT02036437|Drug|Dinoprostone 3 mg|Dinoprostone 3 mg (Dinoglandin® Alexandria Co. for Pharmaceuticals) will be inserted in the posterior vaginal fornix and repeated after six hours if contractions are inadequate (i.e. two doses maximum). If the contractions become inadequate, augmentation of the active phase of labor will be attempted by Syntocinon (oxytocin) infusion +/- amniotomy.
16116902|NCT02036424|Drug|Ozurdex|intravitreal steroid
16116903|NCT02036424|Drug|Bevacizumab|antiVEGF
16116904|NCT02036398|Device|Double J stent without nephrostomy|Double J stent only left at the end of the procedure without placement of a nephrostomy tube
16116905|NCT02036398|Device|nephrostomy tube and double J stent|Double J stent and nephrostomy tube left at end of procedure
16116906|NCT02036372|Drug|Liraglutide|
16116907|NCT02036372|Drug|Insulin bolus|
16116908|NCT02036372|Drug|GIK infusion|continuous infusion
16116909|NCT02036359|Drug|erlotinib|150mg/day for 9 weeks unless disease progression, unacceptable toxicity or death.
16116910|NCT02036359|Drug|docetaxel|receive 3 cycles (9 weeks) of chemotherapy with docetaxel 35mg/m2 IV on day 1 and day 8, and cisplatin 75mg/m2 on day 8.
16116911|NCT02036346|Dietary Supplement|Oral Ηydration Solution|Oral rehydration solution containing: sodium chloride, sodium citrate, glucose, magnesium citrate, food additives and water.
16116912|NCT02036346|Other|Advise on calculated oral fluid requirements|
16116913|NCT02036346|Other|No nutritional advice will be given|
16116914|NCT02036320|Device|etafilcon A|Each study subject will be exposed to both test lenses following a washout period of five minutes between test periods.
16116915|NCT02036307|Dietary Supplement|DHA-enriched|DHA 3g + 600 mg EPA in 6 g of fish oil/day given for 4 weeks
16116916|NCT02036307|Dietary Supplement|EPA-enriched|EPA 2.4 g + DHA 600mg in 6 g of fish oil/day for 4 weeks
16116917|NCT02036294|Other|BREATHE program|A patient and family- centered transitional care intervention that includes a comprehensive biopsychosocial assessment, a tailored treatment plan, a tailored disease management program, and care management support services .
16116918|NCT02036294|Other|Usual Care|Standard Healthcare Services
16116919|NCT02036281|Drug|Substance P-Saporin|
16116920|NCT02036268|Behavioral|Standard|Standard ostomy education
16116921|NCT02036268|Behavioral|Pre-operative Education|In addition to standard ostomy education, an additional pre-operative ostomy education session will be conducted with the subject.
16116922|NCT02036268|Behavioral|Two-week Post Operative Education|In addition to standard ostomy education and an additional pre-operative ostomy education session, another ostomy education session will be conducted with the subject two weeks post-op.
16116923|NCT02036255|Drug|Taurolidine Urokinase|
16116924|NCT02036255|Drug|Taurolidine Heparin|
16116925|NCT02036242|Drug|Sole local anesthetic|0.125% ropivacaine 10-15 ml every 1h during labor delivery
16116926|NCT02036242|Drug|Sufentanil (Opioid plus local anesthetic)|Sufentanil combined with 0.125% ropivacaine, 10-15 ml every 1h during labor delivery
16116927|NCT02036242|Drug|Ropivacaine|
16116928|NCT02036229|Drug|ivermectin cream 0.5%|Each participant will be treated with topical ivermectin cream 0.5% qd for one half of the face and with a vehicle cream qd for the other half of the face for 1 month. In the second month all patients will be treated with ivermectin cream for the entire skin involvement.
16116929|NCT02036203|Device|SCu300A IUB|Spherical copper contraceptive
16116930|NCT02036203|Device|TCu380A IUD|T-shaped copper IUD
16116931|NCT02036177|Device|SCu300A IUB intrauterine device|Spherical copper IUD
16116932|NCT02036177|Device|T380A IUD|T-shaped copper IUD
16116933|NCT02036164|Radiation|Pelvic radiation|"Radiation:
~Pelvic radiation 1.8 Gy/ day, 5 days/ week, 6 weeks
~Brachytherapy 30-35 Gy for 4-5 times"
16116934|NCT02036164|Drug|Cisplatin|Cisplatin 40 mg/m2 i.v.
16116935|NCT02036164|Drug|Paclitaxel|Paclitaxel 175 mg m2 i.v.
16116936|NCT02036164|Drug|Carboplatin|Carboplatin AUC 5 i.v.
16116937|NCT02036151|Drug|xylitol|Mothers in the experimental group were instructed to chew 1 pellet of xylitol gum (Fennobon Oy, Yrittäjäntie, Finneland -gum, 3 times ) for a period of 3 months. control mothers did not receive any medications. All mothers received oral hygiene instructions and restorative treatment when needed. Offspring of both the experimental and control groups did not receive any medication and were followed for at 6,12, 18 and 24 month from initiation of mothers consumption. month
16116938|NCT02036151|Drug|fluoride varnish application|The control group participated in a preventive program under the supervision of the Pediatric Dentistry Department. The program activities consisted of oral hygiene instructions, fluoride varnish application (Duraphat 5% Na F ,Ultradent Products, Utah, USA) and restorative treatment when needed.
16116939|NCT02036138|Procedure|Laparoscopic Sleeve Gastrectomy|
16116940|NCT02036138|Procedure|Laparoscopic Roux-en-Y Gastric Bypass|
16116941|NCT02036138|Drug|Advanced Medical Therapy|
16116942|NCT02036125|Device|Ultrasound|Subjects will receive an ultrasound guided injection of 40 mg of methylprednisolone.
16116943|NCT02036125|Drug|methylprednisolone|Subjects will receive a blind injection of 40 mg of methylprednisolone.
16116944|NCT02036112|Procedure|conventional ELAPE|device
16116946|NCT02036099|Other|Driving in Mild Dementia Decision Tool|
16116947|NCT02036086|Drug|Vemurafenib|Drug
16116948|NCT02036086|Drug|Cobimetinib|Drug
16116949|NCT02036073|Drug|recombinant human erythropoietin|rhEPO 500U/kg was injected within 24h after birth, subsequent injection was given each other day fro 2 weeks.
16116950|NCT02036060|Drug|docetaxel 75 mg/m2 + prednisone 10 mg/d + abiraterone 1000 mg/d|Docetaxel 75 mg/m2 + prednisone 10 mg/d + abiraterone 1000 mg/d in 21 day cycles.
16116951|NCT02036060|Drug|docetaxel 75 mg/m2 + prednisone 10 mg/d|Docetaxel 75 mg/m2 plus prednisone 10 mg/d in 21 day cycles.
16116952|NCT02036047|Device|exclusive cold polypectomy snare (Exacto cold snare, product number 00711115)|
16116953|NCT02036047|Device|Regular polypectomy snare (Snare Master, SD-210U-10)|
16116954|NCT02036034|Device|forced air warmer (Bair Hugger)|forced air warmer placed under the chin before draping, forced air warmer inflated after draping is completed.
16116955|NCT02036034|Device|warming blanket|warming blanket placed on torso of patient under the drape.
16116956|NCT02036008|Other|Liver MRI with Gdfos|"Participants will receive Gdfos at a dose of 10 mL of 0.25mmol/mL. This will be administered automatically using an MRI-compatible power injector, as a bolus through an intravenous line placed in an antecubital vein at a rate of 1.5 mL/s followed by 25 mL of 0.9% saline flush.
~Participants will be imaged using a 3.0 T MRI scanner with an 8 channel body phased array coil utilized covering the entire liver. Images of the liver will be obtained including: axial precontrast phase, axial arterial phase, axial portovenous phase, axial 5 minute delayed phase, axial 10 minute delayed phase, axial 20 minute delayed phase.
~This study will be performed within 4 weeks of the MRI study with EcGd."
16116957|NCT02036008|Other|Liver MRI with EcGd|"Participants will receive a liver MRI with EcGd as per clinical institutional protocol.
~Participants will receive EcGd at a dose of 0.1 mL/kg body mass up to 10 mL. This will be administered automatically using an MRI-compatible power injector, as a bolus through an intravenous line placed in an antecubital vein at a rate of 1.5 mL/s followed by 25 mL of 0.9% saline flush.
~Participants will be imaged using a 3.0 T MRI scanner with an 8 channel body phased array coil utilized covering the entire liver. Images of the liver will be obtained including: axial precontrast phase, axial arterial phase, axial portovenous phase, axial 5 minute delayed phase, axial 10 minute delayed phase, axial 20 minute delayed phase. Additional noncontrast images will be obtained as per institutional protocol, including diffusion weighted imaging, in/out of phase imaging, and T2 weighted imaging."
16116958|NCT02035995|Other|Pregnant volunteers with GDM|
16116959|NCT02035982|Drug|Cholinesterase Inhibitor|"For participants randomized into the active treatment arm, they will be provided with the following study medications:
~Donepezil - 5 mg or 10 mg Galantamine - 8 mg and 16 mg and 24 mg Rivastigmine - 1.5 mg and 3 mg
~The type of study medication provided will depend on the type and dosage of the cholinesterase inhibitor they have been receiving for the last 3 months of their regular treatment. For example, if that have been taking Donepezil - 5 mg daily, they will continue on that same medication, dosage and frequency."
16116960|NCT02035982|Drug|Placebo|For participants randomized into the placebo intervention, placebo capsules will match capsules in the active intervention.
16116961|NCT02035969|Behavioral|Enhanced Treatment Support (ETS)|"Peer supporters, who are also caregivers of HIV-infected children, organize peer support group meetings. In the meetings one peer supporter discusses problems related to adherence with caretakers and provides them with information. Another supporter provides children above 3 years of age with age relevant information about their disease and treatment as well as games and play to enhance group bounds. The supporter will also have weekly telephone contact with all caretakers to assess the condition of the child.
~For children with poor adherence individual support to caretakers and patients will be arranged to assess the child's condition and reason for poor adherence, in case of complications the supporter gives advice or refers the child for medical checkup."
16116962|NCT02035956|Biological|IVAC MUTANOME, RBL001/RBL002|Each patient will receive multiple repeated intranodal injections of IVAC MUTANOME vaccine with or without initial treatment with RBL001/RBL002.
16116963|NCT02035943|Dietary Supplement|Insulin separated|separate continuos infusion of insulin
16116964|NCT02035943|Dietary Supplement|Insulin added to parenteral nutrition|Insulin added to parenteral nutrition
16116965|NCT02035930|Drug|dexmedetomidine|
16116966|NCT02035917|Device|Locking plate|
16116967|NCT02035917|Device|Non-Locking plate|
16116968|NCT02035904|Drug|Levobupivacaine PCIA (Patient Controlled Intrawound Analgesia)|patient controlled infusion from the 2nd day after surgery
16116969|NCT02035904|Drug|saline|patient controlled infusion from the 2nd day after surgery
16116970|NCT02035904|Drug|Levobupivacaine continuous infusion|Continuous infusion Levobupivacaine 0,25% 5ml/h for 24 hs in all patients
16116971|NCT02035904|Device|intrawound infusion catheter|placed by surgeon at the end surgery in all patients
16116972|NCT02035904|Drug|morphine|PCA with morphine: 0,5 mg/ml bolus 1 mg lock-out 5 min max 20 mg in 4 hs - for the first 24 hs as rescue analgesia
16116973|NCT02035904|Drug|Patrol|tramadol-paracetamol 37,5/325 mg oral fix combination-rescue analgesia from 2nd day (after morphine PCA removal)
16116974|NCT02035891|Drug|colchicine 0.5mg/d|on the basis of standard therapy to manage hyperglycemia, hypertension,dislipidemia etc.
16116975|NCT02035891|Drug|placebo 0.5mg/d|on the basis of standard therapy to manage hyperglycemia, hypertension,dislipidemia etc.
16116976|NCT02035878|Other|Probiotics|probiotic intervention: 400mg of probiotic capsule
16116977|NCT02035878|Drug|Placebo|placebo comparator
16116978|NCT02035852|Other|MRI|3T MRI vs. 7T MRI
16116979|NCT02035839|Device|Target Temperature Management of 34°C|In hospital target temperature management to achieve core body temperature of 34°C for 24 hours.
16116980|NCT02035839|Device|Target Temperature Management of 32°C|In hospital target temperature management to achieve core body temperature of 32°C for 24 hours.
16116981|NCT02035839|Device|Target Temperature Management of 33°C|In hospital target temperature management to achieve core body temperature of 33°C for 24 hours.
16117020|NCT02035527|Other|Correlative Studies|Correlative studies will be performed at the following time points. A total of three biopsies (blood and tumor samples) will be obtained in consenting patients.Pre-treatment biopsy to establish diagnosis and baseline data, Research biopsy obtained at the end of a two week period of sorafenib monotherapy just prior to administration of cycle1 with cisplatin and docetaxel, Research biopsy obtained at the end of two chemotherapy cycles.
16116982|NCT02035826|Behavioral|Behavioral Economics Intervention|Patients will receive an active intervention for 3 months followed by 3 months of observation. Incentives will be awarded at the end of the first 3 months, based on an improvement of at least 10 mg/dl in LDL relative to the patient's baseline LDL or achieving or sustaining LDL of 100, depending on baseline LDL and FRS. Adherence in all groups will be measured using Vitality GlowCaps as a recording device. Patients in all arms will be given the GlowCaps and instructions on use. Patients will receive adherence feedback electronically with daily lottery awards to match the timing of their task.
16116983|NCT02035813|Drug|Ribociclib|Ribociclib/Everolimus in combination with endocrine therapy
16116984|NCT02035813|Drug|Eribulin|
16116985|NCT02035800|Drug|Adalimumab|Patient will received medication as standard of care
16116986|NCT02035787|Drug|Metformin|Metformin added to standard non-surgical treatment with levonorgestrel-Releasing Intrauterine Device.
16116987|NCT02035774|Procedure|LSIB + SSNB|Patients will receive LSIB (31 ml ropivacaine 7.5 mg/ml)+ SSNB (4 ml Ropivacaine 5 mg/ml) or LSIB (31 ml ropivacaine 7.5 mg/ml)+ SSNB (4 ml placebo, saline)
16116988|NCT02035748|Drug|Ocriplasmin|0.5 mg/0.2 mL solution for injection
16116989|NCT02035735|Procedure|WL and NBI|For each patient with a suspicion of squamous cell carcinoma of the oropharynx, hypopharynx or larynx for whom a laryngoscopy under general anesthesia (LGA) is expected benefit the day before a transnasal endoscopy with white lamp (WL) and NBI by two different operators. Suspected mucosal abnormalities showed by one or the two technics are reported in a table wich describes the different areas of the pharynx and the larynx. During the LGA, several biopsies are performed and identified (WL and/or NBI).
16116990|NCT02035722|Behavioral|Printed materials|AMD-related information is presented to patients in the form of a brochure (i.e. printed materials)
16116991|NCT02035722|Behavioral|Video|AMD-related information is presented as in the form of a video
16116992|NCT02035709|Drug|Hydromorphone|Hydromorphone is given by PCA or TCI-PCA. The TCI-PCA System steer the hydromorphone infusion pump to achieve plasma concentrations of hydromorphone in predefined increasing steps on patient request and in predefined decreasing steps on lack of patient request within predefined plasma concentration range, lock times and infusion speed.
16116993|NCT02035696|Biological|Trivalent influenza vaccine (TIVc)|
16116994|NCT02035696|Biological|Trivalent influenza vaccine-licensed|Licensed influenza vaccine
16116995|NCT02035683|Procedure|PET/CT|PET/CT scan at baseline and 3 weeks after first cycle chemotherapy
16116996|NCT02035670|Other|Two-step diagnostic strategy|"The first step is to differentiate FUO according to the onset of disease and invasive pathogens. Apart from collecting detailed present medical history and careful physical examination, it focuses on seeking the clues of bacterial invasion two weeks before the fever onset from five aspects.To finish this part, the doctor needs to ask for informations following a list we already made, which covers more than forty definite items. If some of these items were proved existed, result of first step would be positive.
~The second step is calculating the integral score of inflammatory biomarkers and vital diagnostic clues, WBC& N, ESR, CRP, LDH, SF, ANCA, ANA, RF, PCT and T-Spot, as well as the clinical findings were included in this integrating system.The results of these items will be recorded and calculated with certain interval of time. If the score were more than nine, this part would be considered. positive."
16116997|NCT02035657|Biological|GLA-SE|Glucopyranosyl Lipid A in Stable Emulsion
16116998|NCT02035644|Drug|Jinlida granules|
16116999|NCT02035644|Drug|placebo granules|
16117000|NCT02035631|Behavioral|Diet|The dietary component, aimed to reduce calorie intake according to individual requirements, will be structured in 1-hour weekly sessions led by trained nutritionists. Sessions will concentrate on teaching participants about food groups, the food pyramid and Mediterranean diet, how to chose, prepare and cook hypo-caloric meals.
16117001|NCT02035631|Behavioral|Physical activity|The physical activity component will include two sessions per week led by trained physical activity monitors including aerobic exercise of high/moderate intensity, and instruction about the at-home exercise activities (3 more sessions).
16117002|NCT02035631|Behavioral|Minimal diet intervention|Some basic diet recommendations
16117003|NCT02035631|Behavioral|Minimal physical activity intervention|Some basic recommendations on physical activity
16117004|NCT02035618|Other|Exercises|Strengthening and stretching
16117005|NCT02035618|Other|Exercises + Manual Therapy|Mobilization; massage; post-isometric relaxation; strengthening; stretching
16117006|NCT02035605|Drug|ALN-AT3SC|Ascending doses of ALN-AT3SC by subcutaneous (sc) injection
16117007|NCT02035605|Drug|Sterile Normal Saline (0.9% NaCl)|Calculated volume to match active comparator
16117008|NCT02035592|Other|Full dose blueberry|"Full dose: 26g of freeze dried blueberry powder to be incorporated into the habitual diet.
~Dietary restrictions will be observed (i.e. avoidance of blueberry, and restricted intake of anthocyanin rich foods) for 21 days prior to the first assessment visit and throughout the study."
16117009|NCT02035592|Other|Half dose blueberry|"Half dose: 26g of freeze dried powder (containing 13g of freeze dried blueberry powder and 13g of placebo comparator material) to be incorporated into the habitual diet.
~Dietary restrictions will be observed (i.e. avoidance of blueberry, and restricted intake of anthocyanin rich foods) for 21 days prior to the first assessment visit and throughout the study."
16117010|NCT02035592|Other|Control|"Control: 26g of placebo comparator material to be incorporated into the habitual diet.
~Dietary restrictions will be observed (i.e. avoidance of blueberry, and restricted intake of anthocyanin rich foods) for 21 days prior to the first assessment visit and throughout the study."
16117011|NCT02035579|Behavioral|Aerobic Training Intervention|
16117012|NCT02035579|Behavioral|Stretching Intervention|
16117014|NCT02035553|Drug|Pimavanserin tartrate|Pimavanserin tartrate, 40 mg (two 20 mg tablets), once daily by mouth (equivalent to 34 mg free base pimavanserin)
16117015|NCT02035553|Drug|Placebo|Placebo, two tablets, once daily by mouth
16117016|NCT02035540|Other|Decellularized human valves|
16117017|NCT02035527|Drug|sorafenib tosylate|Given daily PO in the a.m.
16117018|NCT02035527|Drug|cisplatin|Given IV over 1 hour following Docetaxel administration
16117019|NCT02035527|Drug|docetaxel|Given IV 1 hour prior to cisplatin administration
16117021|NCT02035514|Biological|Bone marrow autologous mesenchymal stem cells transplantation|
16117022|NCT02035501|Drug|L-Tyrosine|
16117023|NCT02035501|Drug|Placebo|
16117024|NCT02035488|Drug|Tobramycin|Tobramycin dry powder 30 mg inhalation per dose; Dose escalation: 30-60-120 and 240 mg, each one time. One dose per week.
16117025|NCT02035475|Device|Intuitive Vessel Sealer|Investigators intend to use this device unilaterally so the contralateral side can serve as an internal control.
16117026|NCT02035449|Device|McGrath MAC|McGrath MAC is a videolaryngoscope
16117027|NCT02035436|Other|Non-sedation|Patients are awake or have natural sleep during mechanical ventilation. Pain is treated with morphine iv.
16117028|NCT02035436|Other|Control: Sedation|Continuous iv-sedation (propofol first 48 hours, from then midazolam) to Ramsey 3-4 with a daily wake up attempt, where sedation is stopped until patient is awake.
16117029|NCT02035423|Dietary Supplement|120 IU milk|Daily consumption of milk fortified with 120 IU vitamin D
16117030|NCT02035423|Dietary Supplement|200 IU Milk|Daily Consumption of milk fortified with 200 IU vitamin D
16117031|NCT02035423|Dietary Supplement|Non-Fortified Milk|Daily consumption of non-fortified milk
16117032|NCT02035410|Procedure|Hydrogen peroxide pretreatment group|Hydrogen peroxide pretreatment perform before cardiac devices Implantation. It disinfects the cardiac devices pocket using Hydrogen peroxide gauze.
16117033|NCT02035397|Drug|Botulinum Toxin Type A|
16117034|NCT02035397|Drug|Saline solution|
16117035|NCT02035384|Drug|turoctocog alfa|Patients will be treated with commercially available turoctocog alfa as prescribed by the treating physician in clinical daily practice and preferably according to the label for turoctocog alfa in the respective countries.
16117036|NCT02035371|Drug|Faster-acting insulin aspart|A single dose will be administered subcutaneously (s.c. under the skin)
16117037|NCT02035371|Drug|insulin aspart|A single dose will be administered subcutaneously (s.c. under the skin)
16117038|NCT02035358|Biological|HyperAcute®-Renal (HAR) Immunotherapy|"HyperAcute®-Renal Immunotherapy consisting of equal cell doses of each of two allogeneic renal cell cancer cell lines (HAR1 and HAR2) engineered to express the murine α(1,3)GT gene.
~Cells will be injected intradermally every 1 week x 4 weeks and then every 2 weeks for 10 immunizations to total 14 immunizations. Dose Cohort 1 will receive 150 million cells per immunization; Dose Cohort 2 will receive 300 million cells per immunization."
16117039|NCT02035345|Drug|Carboplatin|
16117040|NCT02035332|Device|Aurora Endometrial Ablation System|Ablation of the endometrial lining of the uterus using the Aurora System
16117041|NCT02035306|Other|non invasive co-oximetry haemaglobin measurement|
16117042|NCT02035293|Other|PEP|
16117043|NCT02035267|Drug|Deoxycholic Acid|Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
16117044|NCT02035267|Drug|Placebo|Phosphate buffered saline placebo for injection.
16117045|NCT02035254|Other|Web-based Wellness Program|Web-based educational modules and physical activity and/or health weight challenges
16117046|NCT02035241|Dietary Supplement|Spices 1|In this study, subjects are asked to consume 200 ml beverage drinks contain certain amounts of spices 1. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.
16117047|NCT02035241|Dietary Supplement|Spices 2|In this study, subjects are asked to consume 200 ml beverage drinks contain certain amounts of spices 2. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.
16117048|NCT02035241|Dietary Supplement|Spices 3|In this study, subjects are asked to consume 200 ml beverage drinks contain certain amounts of spices 3. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.
16117049|NCT02035241|Dietary Supplement|Herbs 1|In this study, subjects are asked to consume 200 ml beverage drinks contain certain amounts of herbs 1. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.
16117050|NCT02035241|Dietary Supplement|Herbs 2|In this study, subjects are asked to consume 200 ml beverage drinks contain certain amounts of herbs 2. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.
16117051|NCT02035241|Dietary Supplement|Control drink|As a control, subjects are asked to consume 200 ml control drinks. Following 10 min. beverage consumption, subjects will be given standardized breakfast corresponding to 50 g carbohydrate.
16117052|NCT02035228|Device|Abdominal Stimulation - low / early|"Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
~Stimulation is applied at low stimulation current for the first half of exhalation"
16117053|NCT02035228|Device|Abdominal stimulation - low/late|"Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
~Stimulation is applied at low stimulation current for the second half of exhalation"
16117054|NCT02035228|Device|Abdominal Stimulation - low/full|"Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
~Stimulation is applied at low stimulation current throughout exhalation"
16117055|NCT02035228|Device|Abdominal stimulation - med/early|"Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
~Stimulation is applied at medium stimulation current for the first half of exhalation"
16117056|NCT02035228|Device|Abdominal stimulation - med/late|"Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
~Stimulation is applied at medium stimulation current for the second half of exhalation"
16117057|NCT02035228|Device|Abdominal Stimulation - med/full|"Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
~Stimulation is applied at medium stimulation current throughout exhalation"
16117058|NCT02035228|Device|Abdominal Stimulation - high/early|"Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
~Stimulation is applied at high stimulation current for the first half of exhalation"
16117059|NCT02035228|Device|Abdominal Stimulation - high/late|"Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
~Stimulation is applied at hig stimulation current for the second half of exhalation"
16117433|NCT02032277|Drug|Paclitaxel|Paclitaxel
16117060|NCT02035228|Device|Abdominal Stimulation - high/full|"Transcutaneous electrical stimulation applied to the abdominal wall muscles in synchronous with volitional exhalation.
~Stimulation is applied at high stimulation current throughout exhalation"
16117061|NCT02035215|Drug|Atorvastatin 20mg|
16117062|NCT02035215|Drug|Omega-3-acids ethylesters 90 4g|
16117063|NCT02035215|Other|Placebo(Omega-3-acids ethylesters 90)|
16117064|NCT02035202|Behavioral|CBT2go|CBT administered using mobile intervention.
16117065|NCT02035202|Device|Smartphone|A smartphone platform will be used to deliver the CBT2go behavioral intervention and the surveys in the EMA-only arm.
16117066|NCT02035163|Procedure|Two sites cryoablation|Two ganglionic plexi around atrium was performed with 90-second cryoablation.
16117067|NCT02035150|Dietary Supplement|Oatmeal|A breakfast consisting of oatmeal
16117068|NCT02035150|Dietary Supplement|Frosted Flakes|A breakfast consisting of Frosted Flakes and milk
16117069|NCT02035150|Dietary Supplement|No Breakfast|A breakfast consisting of plain water
16117070|NCT02035137|Radiation|131I-MIBG|
16117071|NCT02035137|Drug|Vincristine|
16117072|NCT02035137|Drug|Irinotecan|
16117073|NCT02035137|Drug|Vorinostat|
16117074|NCT02035124|Drug|BKM 120|
16117075|NCT02035124|Drug|Cabazitaxel|
16117076|NCT02035111|Drug|Tianshu capsule|
16117077|NCT02035111|Drug|Sugar pill|
16117078|NCT02035098|Other|the Pac-IFicO programme|The Pac-IFicO programme is a complex interventions with multiple components. It includes focus group with ward professionals for identifying possible local obstacles to optimal pain control, informative material for the patients, an educational programs performed through guides from the wards, and an organisational intervention to the ward.
16117079|NCT02035085|Drug|CS-1000 labeled SVF cells|Patients will undergo autologous transplantation of CS-1000 labelled SVF cells in a sterile environment.
16117080|NCT02035072|Drug|Gemcitabine|Gemcitabine 1000 mg/m2
16117081|NCT02035072|Drug|Oxaliplatin|Oxaliplatin 100 mg/m2
16117082|NCT02035072|Radiation|Hypofractionated RT|Hypofractionated radiotherapy (35 Gy in 7 fractions)
16117083|NCT02035046|Procedure|Samplings of blood|
16117084|NCT02035046|Procedure|Sampling of urine|
16117085|NCT02035046|Procedure|Measure of the blood pressure|
16117086|NCT02035046|Procedure|glycemia test|
16117087|NCT02035020|Drug|gamma interferon|IFN gamma 1b (Immukin ®) will be administered by subcutaneous route at day 0, 14 and 28 at a dose of 100, 150 and 200 ug respectively.
16117088|NCT02035007|Device|PiCCO Catheter (Pulsiocath 5F)|Measuring of PiCCO derived values
16117089|NCT02034994|Behavioral|Eating behavior and physical activity change|A combination of two prevention school based programs will be addressed to schoolchildren over one year. Primary prevention will be developed monthly in order to reduce cookies and sugar sweetened beverages consumption, reduction of sedentary activities, increase meal consumption frequency and quality etc, in all children from 6th and 7th grades. Overweight and obese children will be invited to participate on a secondary prevention program in which daily physical activity classes will be performed by physical education teachers in school facilities.
16117090|NCT02034981|Drug|Crizotinib|"Patients will receive oral crizotinib, daily continuously, until progression or unacceptable toxicity develops.
~-250 mg twice daily for adults ≥ 18 years of age
~280 mg/m² twice daily for children and adolescents aged from 1 to 17 (except ALCL).
~165 mg/m² twice daily for ALCL patients aged from 1 to 17."
16117091|NCT02034968|Drug|Nimotuzumab|Nimotuzumab: 200mg,IV once a week during chemotherapy.
16117092|NCT02034955|Radiation|Post-operative Adaptive Radiation Therapy|
16117093|NCT02034942|Other|Non-sedation|
16117094|NCT02034942|Other|Sedation, control|
16117095|NCT02034929|Device|EndoCuff-assisted colonoscopy|EC-assisted colonoscopy
16117096|NCT02034929|Device|Standard colonoscopy|Standard colonoscopy
16117097|NCT02034916|Drug|talazoparib|
16117098|NCT02034903|Other|Feedings warmed with commercial warmer|
16117099|NCT02034890|Drug|Hyaluronic Acid|intravesical instillation of 40 mg of hyaluronic acid in 6 specific time points: 1,2,3 and 4 weeks postoperatively (After radical cystectomy and orthotopic neobladder reconstruction) 2 and 3 months postoperatively
16117100|NCT02034877|Biological|13-valent Pneumococcal conjugate vaccine|1 dose (0.5 mL/ pre-filed syringe) of 13vPnC administered at visit 1
16117101|NCT02034877|Procedure|Blood sample collection|10 mL of blood will be collected just before and approximately 1 month after vaccination.
16117102|NCT02034864|Other|Osteopathic manipulative treatment|A standardized manipulative treatment according to the results of a physical examination including 7 anatomical areas will be given by trained osteopaths during 6 sessions (with an interval of 2 weeks between 2 sessions). Each session will last 45 minutes. Osteopaths will have 3 days of training in standardized manipulative treatment.
16117103|NCT02034864|Other|Placebo of osteopathic manipulative treatment|"A standardized placebo of manipulative treatment consisting in light touch and according to the results of a physical examination including 7 anatomical areas will be given by trained osteopaths during 6 sessions (with an interval of 2 weeks between 2 sessions). Each session will last 45 minutes. Osteopaths will have 3 days of training in standardized placebo of manipulative treatment."
16117104|NCT02034838|Drug|atazanavir 300mg boosted with ritonavir 50 mg|"atazanavir 300 mg with ritonavir 100 mg once a day at 8:00 am for study day 1 and 9.
~atazanavir 300 mg with ritonavir 50 mg once a day at 8:00 am for 7 consecutive days (study days 2-8)"
16117105|NCT02034825|Other|Decipher Questionnaire|Each participant will complete the pre and post-Decipher eCRQs for a minimum of 5 cases, and a maximum of 25 cases.
16117106|NCT02034812|Other|Decipher Questionnaire|Pathological data from 12 de-identified patient cases will be reviewed by at least 25 Radiation Oncologists before and after exposure to the Decipher test results. Given the number of patient cases, reviewed by each participant, this allows for assessment of decision making based on 300 patient case reviews at each time point, immediately following RP and at the time of PSA rise.
16117107|NCT02034799|Biological|Bioseal Fibrin Sealant|
16117108|NCT02034799|Other|Standard of Care (SoC)|
16117239|NCT02033889|Drug|Placebo to Ertugliflozin|Placebo to ertuglioflozin (1 placebo ertugliflozin 5 mg tablet and/or 1 placebo ertugliflozin 10 mg tablet), orally once daily from Day 1 to Week 104.
16117434|NCT02032277|Drug|Carboplatin|Carboplatin
16117109|NCT02034786|Procedure|Adipose tissue collection|"Only the patients selected for the Test Group will go through the procedure. The adipose tissue collection will occur in an elective surgery liposuction, in patients who meet the inclusion criteria, after signing the informed consent form. Thus, the material that would be disposed after surgery will be donated to the study.
~The material for the study will be collected by the tumescent liposuction technique, which involves the removal of subcutaneous fat under local anesthesia."
16117110|NCT02034786|Biological|Transdermal injection|Transdermal injection of the filler agent composed of mesenchymal stem cells derived from autologous adipose tissue associated with hyaluronic acid.
16117111|NCT02034786|Procedure|Transdermal injection|Transdermal injection of hyaluronic acid only.
16117112|NCT02034773|Drug|CC-220|CC-220 0.3mg will be administered once daily for 14 days
16117113|NCT02034773|Drug|CC-220|CC-220 1mg will be administered once daily for 28 days + 1 dose of tetanus toxoid vaccination and 1 dose of pneumococcal vaccination
16117114|NCT02034773|Drug|CC-220|CC-220 0.3mg will be administered once daily for 28 days
16117115|NCT02034773|Drug|CC-220|CC-220 1mg will be administered once daily for 7 days on 2 separate occasions, with a 7-day washout in between, for a total of 14 days of dosing
16117116|NCT02034773|Drug|Placebo|Placebo will be administered once daily for up to 28 days
16117117|NCT02034773|Drug|CC-220|CC-220 0.3mg will be administered every 3 days for 14 days (5 total doses)
16117118|NCT02034773|Drug|CC-220|CC-220 1mg (once every 7 days for 28 days)
16117119|NCT02034773|Drug|CC-220|CC-220 1mg will be administered as a single dose in each of 2 study periods; once as a formulated capsule and once as two reference capsules
16117120|NCT02034760|Procedure|Heavy Resistance Training|Supervised Heavy Resistance Training three times weekly for 52 weeks.
16117121|NCT02034760|Procedure|Light Intensity Training|Home-based Light Intensity Training three-five times weekly for 52 weeks.
16117122|NCT02034760|Dietary Supplement|Protein Whey|Two daily 20g whey protein and 10g carbohydrate supplementations for 52 weeks.
16117123|NCT02034760|Dietary Supplement|Protein Collagen|Two daily 20g collagen protein and 10g carbohydrate supplementations for 52 weeks.
16117124|NCT02034760|Dietary Supplement|Carbohydrate|Two daily 30g carbohydrate supplementations for 52 weeks.
16117125|NCT02034747|Drug|Advagraf|oral
16117126|NCT02034747|Drug|Corticosteroid|oral
16117127|NCT02034734|Drug|ASP3652|oral
16117128|NCT02034721|Dietary Supplement|Protein supplement|24 g protein before, 12 g during, and 24 g after eccentric exercise
16117129|NCT02034721|Dietary Supplement|Placebo|Placebo
16117130|NCT02034708|Drug|Dotarem®|Dotarem® 0.1 mmoL/kg (0.2 mL/kg), intravenous (I.V.) bolus.
16117131|NCT02034708|Drug|Gadovist®/Gadavist®|Gadovist®/Gadavist®, 0.1mmol/kg (0.1mL/kg), intravenous (I.V.) bolus.
16117132|NCT02034682|Drug|Volulyte 6%|During elective coronary artery bypass grafting surgery, patients need to be attached to a cardiopulmonary bypass circuit. Administration of Volulyte 6% to the cardiopulmonary bypass circuit.
16117133|NCT02034682|Drug|Geloplasma|During elective coronary artery bypass grafting surgery, patients need to be attached to a cardiopulmonary bypass circuit. Administration of Geloplasma to the cardiopulmonary bypass circuit.
16117134|NCT02034669|Device|Laminectomy|surgical laminectomy with glial scar resection
16117135|NCT02034669|Device|Intradural space|ADSCs injection into Intradural space at damage site
16117136|NCT02034669|Device|Intrathecal|ADSCs Intrathecal into lumbar puncture
16117137|NCT02034669|Device|Intravenous|ADSCs intravenous
16117138|NCT02034643|Procedure|balloon pressure adjustment|Tracheal cuff pressure was adjusted to 18 mmHg (25 cmH2O) before TEE probe insertion
16117139|NCT02034630|Drug|Busulfan|First dose: busulfan (120 mg/m2 ivs once daily) (if age<1 yr: 80 mg/ m2) Second to forth dose: according to the daily pharmacokinetic study
16117140|NCT02034617|Behavioral|LiMoNid|One LiMoNid observation will be performed on day 1-3 post birth, one in time of discharge, and one in the home when the infant has reached 40 weeks (+/- 2 week). All observations are performed in presence of and in collaboration with the parents with the outspoken aim to guide the parents to learn how to read and respond to their infant' signals
16117141|NCT02034604|Drug|Naftofidil|
16117142|NCT02034604|Drug|Tamsulosin|
16117143|NCT02034591|Drug|Apixaban|
16117144|NCT02034591|Dietary Supplement|Boost Plus|
16117145|NCT02034578|Drug|Apixaban|
16117146|NCT02034565|Drug|Apixaban|
16117147|NCT02034552|Drug|Radium-223 dichloride (Xofigo, BAY88-8223)|Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg (55 kBq/kg after implementation of NIST [National Institute of Standards and Technology] update) every 4 weeks x 6 doses intravenous slow bolus
16117148|NCT02034552|Drug|Abiraterone acetate|Abiraterone acetate 1000 mg (4 x 250 mg tablets) taken orally once daily for up to two years following last dose of radium-223 dichloride
16117149|NCT02034552|Drug|Prednisone|Prednisone 5 mg capsule taken orally twice daily for up to two years following last dose of radium-223 dichloride
16117150|NCT02034552|Drug|Enzalutamide|Enzalutamide 160 mg (four 40 mg capsules) taken orally once daily for up to two years following last dose of radium-223 dichloride
16117151|NCT02034539|Device|VADOplex system|intermittent automatic pneumatic compression of the sole of the foot by the VADOplex system
16117152|NCT02034526|Device|DDDR-60|DDDR, lower pacing rate 60 bpm, RR activated (low-moderate)
16117153|NCT02034526|Device|DDD-40|DDD, lower pacing rate 40 bpm, RR function off
16117154|NCT02034513|Drug|insulin degludec|Administered once daily, injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.
16117155|NCT02034513|Drug|insulin glargine|Administered once daily, injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.
16117156|NCT02034513|Drug|insulin aspart|Administered 2-4 times daily injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.
16117157|NCT02034500|Biological|S. sonnei 1790GAHB|
16117158|NCT02034500|Biological|Placebo|
16117159|NCT02034487|Other|retrospective data collection|
16117160|NCT02034474|Drug|Tocilizumab|8mg/kg intravenously via iv drip over 60 min
16117161|NCT02034474|Drug|Placebo|intravenously via iv drip over 60 min
16117435|NCT02032277|Drug|Veliparib|Veliparib
16117436|NCT02032277|Drug|Placebo|Placebo for Veliparib
16117162|NCT02034461|Device|Utah Slanted Electrode Array|This study is using the microelectrode array device for scientific purposes only. This device will not be promoted or test marketed, and is not available for commercial distribution. There will be no costs to the participants for this device. This study is not aimed at collecting data for pre-market approval.
16117163|NCT02034448|Procedure|Continuous Renal Replacement Therapy|
16117164|NCT02034435|Other|Low Salt diet plus Placebo tablet|
16117165|NCT02034435|Other|Low Sodium diet plus Salt tablet|
16117166|NCT02034435|Drug|Epleronone|50mg daily
16117167|NCT02034435|Drug|Amlodipine|5mg daily
16117168|NCT02034422|Dietary Supplement|Oral Antioxidant|Consisting of vitamins C, E and alpha lipoic acid.
16117169|NCT02034422|Other|Exercise rehabilitation|8 weeks of exercise rehabilitation
16117172|NCT02034396|Procedure|Blood Draw|One blood draw at enrollment
16117173|NCT02034383|Other|Control|Controlled diet for 3 weeks with 0 servings/day of almonds.
16117174|NCT02034383|Other|Whole Almonds|Controlled diet for 3 weeks with 1.5 servings/day of whole, natural almonds.
16117175|NCT02034383|Other|Roasted Whole Almonds|Controlled diet for 3 weeks with 1.5 servings/day of roasted whole almonds.
16117176|NCT02034383|Other|Diced Almonds|Controlled diet for 3 weeks with 1.5 servings/day of diced almonds.
16117177|NCT02034383|Other|Almond Butter|Controlled diet for 3 weeks with 1.5 servings/day of almond butter.
16117178|NCT02034370|Device|Lung-function spirometry test|5 minute lung function test performed once preoperatively and once postoperatively
16117179|NCT02034370|Device|Overnight sleep test|Somte sleep monitor to be worn two nights before and the night of surgery.
16117180|NCT02034357|Other|Neurocognitive function|Each eligible participant will complete a neuro-cognitive assessment as measured by CVLT at the beginning of the study. Neurocognitive evaluations will be repeated at 4-month and 1-year follow-up.
16117181|NCT02034357|Other|Sleep evaluations|Each eligible participant will complete sleep questionnaires and undergo a baseline sleep study at the beginning of the study. The sleep questionnaires will be repeated at 4-month and 1-year follow-up.
16117182|NCT02034344|Procedure|Skin biopsy|Participants with LE will have 2 adjacent 4 mm punch biopsies collected from involved and uninvolved skin at one timepoint and again from the involved skin site approximately 12 weeks later. Healthy participants will have 2 adjacent 4 mm punch biopsies taken at one timepoint.
16117183|NCT02034344|Procedure|Blood collection|Blood for serum analyses will be taken from all participants. Blood for DNA analysis will only be taken from participants who consent to this separately.
16117184|NCT02034344|Procedure|Urine collection|Urine will be collected from all participants.
16117185|NCT02034331|Drug|Insulin iontophoresis|For insulin iontophoresis, the cathode electrode will contain 0.2 ml of liquid insulin. For preparation and instrumentation, the arms will be uncovered below the elbow; the participant's lower extremities will be uncovered below knee for leg evaluations. The laser Doppler flowmetry (LDF) lead will be placed bilaterally, 2 inches proximal to the lateral malleolus over the peroneus longus muscle. For arm evaluations, a lead will be placed (and secured with dual-sided transparent tape) bilaterally, 2 inches distal to the lateral epicondyle over the flexor carpi ulnaris muscle along the midline with the ulnar process. Baseline and peak cutaneous blood flow responses to application of insulin iontophoresis will be determined for each LDF lead during the evaluation.
16117186|NCT02034331|Drug|Placebo Iontophoresis|For placebo iontophoresis, the cathode electrode will contain 0.2 ml of preservative-free normal saline; the anode electrode will contain a medical grade adhesive for skin placement and last 20 minutes. Preparation, instrumentation and data collection for this intervention are the same as the insulin iontophoresis.
16117187|NCT02034331|Drug|Acetylcholine Iontophoresis|For acetylcholine iontophoresis, the anode electrode will contain 0.2 ml of 1% acetylcholine chloride; the cathode electrode will contain a medical grade adhesive for skin placement and last 20 minutes. Preparation, instrumentation and data collection for this intervention are the same as the insulin iontophoresis.
16117188|NCT02034331|Other|Heat application|For the provocation with heat, an insulated thermal heat pack (~106°F) will be applied to the exposed arm or leg for 18 minutes. The thermal heat pack is comparable to what is routinely used as a heat therapy in conventional rehabilitation settings. LDF leads and temperature sensors will be placed in the previously specified locations to evaluate the changes.
16117189|NCT02034292|Drug|Clopidogrel|
16117190|NCT02034292|Drug|Aspirin|
16117191|NCT02034292|Drug|APD791|
16117192|NCT02034292|Drug|Placebo|
16117193|NCT02034279|Drug|Albumin|Intravenous infusion of 20% albumin
16117194|NCT02034266|Dietary Supplement|Omega-3 supplementation|5 mL twice daily, administered under the tongue
16117195|NCT02034253|Drug|Risperidone|Patients with psychosis will be provided a 16 week regimen of the antipsychotic drug Risperidone in accordance with standard care.
16117196|NCT02034227|Drug|SG2000|intravenous doses given on Days 1, 2, and 3 of each 21-day cycle (1 to 6 cycles).
16117197|NCT02034214|Behavioral|Life skills education|The life skills curriculum drew upon Stepping Stones and CDC-Zimbabwe Talk Time, developed with input from the target population. It consisted of 14 modules delivered to groups of 25 over 4-6 weeks on: HIV/STI and reproductive health; relationship negotiation; strategies to avoid violence;and identification of safe and risky places in the community. Participants also attended a six-weeks-long home-based care training conducted through Red Cross Zimbabwe, to gain skills on safely caring for people living with HIV.
16117198|NCT02034214|Other|Reproductive health services|All participants were provided a health screening at every study visit and were treated for treatable STIs and minor ailments. They received condoms, and contraceptive pills or injectable free upon request. Participants who tested positive for HIV were referred to local clinics, where the study team assisted with ART registration including payment for CD4 tests required for enrolment.
16117240|NCT02033889|Other|Glimepiride|Open-label Glimepiride will be used for glycemic rescue therapy (up to a maximum of 6 or 8 mg per day, based on the local label of glimepiride) in the 26-week initial period. Blinded Glimepiride (up to a maximum of 6 or 8 mg per day, based on the local label of glimepiride will be used in the 78-week extension period in participants who were not rescued with open-label glimepiride during the 26-week initial period.
16117199|NCT02034214|Behavioral|Economic livelihoods|The Livelihoods intervention consisted of financial literacy and a choice of vocational training at local training institutes. Courses were 6-months-long, conducted in English, with a practical and a theoretical component. In spite of encouragement to venture outside of accepted gender norms, the most popular courses were hairdressing, garment-making, and receptionist/secretarial and nurse-aid training. Participants who passed developed business plans that were supported with a micro-grant valued at $100US in the form of capital equipment, supplies or additional training.
16117200|NCT02034201|Drug|Lisdexamfetamine|
16117201|NCT02034201|Drug|Placebo|
16117202|NCT02034188|Biological|Umbilical cord mesenchymal stem cells|
16117203|NCT02034175|Device|SomnaPatch|SomnaPatch is a standalone flexible diagnostic skin-adhesive patch with electronics inside. The patch is placed on the patient's face.
16117204|NCT02034175|Device|Polysomnography|Polysomnography performed in a sleep lab is considered a gold standard in diagnosing the sleep breathing disorders.
16117205|NCT02034162|Drug|Mebendazole|Mebendazole will be administered as a single-dose 500 mg chewable tablet. For children 1 year to <36 months of age, the tablet will be placed in a teaspoon and bottled water will be poured into the remaining volume of the teaspoon. The tablet will then be allowed to absorb all water (absorption time has been observed to take less than 1 minute) to become a soft semi-solid mass without any hard particles. This semi-solid form can then be easily ingested by the child.
16117206|NCT02034162|Drug|Placebo|Matching placebo will be administered as a single-dose chewable tablet. For children 1 year to <36 months of age, the tablet will be placed in a teaspoon and bottled water will be poured into the remaining volume of the teaspoon. The tablet will then be allowed to absorb all water (absorption time has been observed to take less than 1 minute) to become a soft semi-solid mass without any hard particles. This semi-solid form can then be easily ingested by the child.
16117207|NCT02034149|Behavioral|general management|All participants received a general education with the knowledge on care for early chronic kidney disease recently establishes by the National Health Insurance system. We then used the cross-theoretical model to assess the intervention among the three groups.
16117208|NCT02034149|Behavioral|self-management|Participants in the self-management group are expected to emphasize on self-managed interventions, including self-monitoring and records keeping, self-education with DVD courses. We negotiated their behavior change set goals for them etc.
16117209|NCT02034149|Behavioral|peer-assisted management|The peer-assisted management group received similar program for 3 months, the peer oriented group activities followed, including group discussions to share experience and sports map etc.
16117210|NCT02034136|Dietary Supplement|Ginsenoside|3.0 g/ d for 28 days
16117211|NCT02034136|Dietary Supplement|Dietary fiber fill|3g/day, 28days
16117212|NCT02034123|Drug|GSK2879552|Subjects will receive GSK2879552orally with approximately 200 milliliter (mL) of water.
16117213|NCT02034110|Drug|Dabrafenib|Dabrafenib is a 150 mg twice daily capsule administered orally on a continuous basis.
16117214|NCT02034110|Drug|Trametinib|Trametinib is a 2 mg once daily tablet administered orally on a continuous basis.
16117215|NCT02034097|Drug|Foretinib|Round yellow tablet containing 15 mg of foretinib will be orally administered in a dose level of 45 mg (3 x 15 mg) or 60 mg (4 x 15 mg) OD until disease progression
16117216|NCT02034097|Drug|Erlotinib|Round white tablet containing either 25 mg, 100 mg, or 150 mg of erlotinib will be orally administered in a dose level of 150 mg OD until disease progression
16117217|NCT02034084|Procedure|left radial approach|Coronary diagnostic procedures performed through left radial approach
16117218|NCT02034084|Procedure|Right radial approach|coronary diagnostic procedures performed through right radial approach
16117219|NCT02034071|Drug|DCCR|
16117220|NCT02034071|Drug|Placebo|
16117221|NCT02034058|Device|Wingspan Stent System|The Wingspan Stent System is used with the Gateway PTA Balloon Catheter. The Wingspan Stent System is a self-expanding, Nitinol stent and delivery system intended for use in the treatment of intracranial atherosclerotic disease. The Gateway PTA Balloon Catheter is an over-the-wire balloon catheter intended for the pre-dilation of the lesion prior to insertion and deployment of the Wingspan Stent System.
16117222|NCT02034045|Other|Community Paramedicine|
16117223|NCT02034045|Other|Usual Care|
16117224|NCT02034032|Procedure|Regenexx SD|stem cell treatment
16117225|NCT02034032|Behavioral|Exercise Therapy|exercise therapy control
16117226|NCT02034019|Drug|Dexamethasone|
16117227|NCT02034019|Drug|Punctum Plug|
16117228|NCT02034006|Drug|Ranibizumab|All patients received a single initial intravitreal injection of ranibizumab 0.5 mg/0.05 ml as per Committee for Human Medicinal Products (CHMP)approval. Further injections might have been required when monitoring reveals disease activity. Disease activity, defined as reduced visual acuity and/or signs of lesion activity, was evaluated based on clinical examination (BCVA, fundus), and/or optical coherence tomography (OCT), and/or fluorescein angiography (FAG). Bilateral treatment was allowed provided at least 14 days of intercurrence.
16117229|NCT02033993|Drug|Nab-Paclitaxel|
16117230|NCT02033993|Drug|Paclitaxel|
16117231|NCT02033980|Device|NBI|All detected colorectal lesions will be examined by high-definition NBI. For type 2 and type 3 lesions, subsequent magnifying NBI examination will be performed.
16117232|NCT02033967|Procedure|vasodilator induced hypovolemia|
16117233|NCT02033941|Drug|Meganatural-Az Grapeseed Extract|Meganatural-Az® doses: 30mg / day for 2 weeks; 4 weeks of 600 mg/day, 4 weeks 1000mg / day
16117234|NCT02033941|Drug|Placebo|Subjects receive capsules identical in appearance to the active agent with the same incremental schedule
16117235|NCT02033915|Other|Interactive discussion group|The investigators adopt the group intervention that provide interactive discussions regarding the assessment of suicide risk among inpatients in a general hospital.
16117236|NCT02033902|Drug|Perampanel|Perampanel tablets are administered orally according to prescribing information and the treating physician's clinical judgment
16117237|NCT02033889|Drug|Ertugliflozin 5 mg|Ertugliflozin 5 mg orally (1 ertugliflozin 5 mg tablet and 1 placebo ertugliflozin 10 mg tablet), once daily from Day 1 to Week 104.
16117238|NCT02033889|Drug|Ertugliflozin 15 mg|Ertugliflozin 15 mg orally (1 ertugliflozin 5 mg tablet and 1 ertugliflozin 10 mg tablet), once daily from Day 1 to Week 104.
16117382|NCT02032693|Other|Placebo|
16118423|NCT02024594|Behavioral|cognitive-behavioral therapy|
16117241|NCT02033889|Drug|Placebo to Glimepiride|Placebo to glimepiride will be used in the 78-week extension period in participants who were not rescued with open-label glimepiride during the 26-week initial period. Dosing and titration of placebo to glimepiride is at the discretion of the investigator.
16117242|NCT02033889|Biological|Basal Insulin|Basal insulin will be administered in the initial 26-week period for participants with glucose values exceeding protocol-specified values and for participants requiring rescue therapy in the 78-week extension period. Dosing and titration of basal insulin is at the discretion of the Investigator.
16117243|NCT02033889|Drug|Metformin|Metformin >=1500 mg/day, orally, once a day
16117244|NCT02033876|Drug|Ursodiol|
16117245|NCT02033850|Behavioral|Attention Process Training-II|Rehabilitation of attention using the Attention Process Training-II
16117246|NCT02033824|Other|dHACM|A piece of dHACM placed over any dural defect or dural closure during craniectomy.
16117247|NCT02033824|Procedure|Craniectomy|Removal of the skull flap followed by closure techniques per current SOC.
16117248|NCT02033798|Drug|Tamsulosin|Once Daily 0.2mg per oral for 6 months
16117249|NCT02033772|Procedure|Thoracoscopic surgery|
16117250|NCT02033759|Device|Bio-Impedance Testing|Participants in the BIA Arm will also undergo bio-impedance testing with this device.
16117251|NCT02033759|Other|Anxiety Questionnaire|21 item questionnaire
16117252|NCT02033759|Other|Traditional Circumferential Measurements|
16117253|NCT02033746|Device|Han's Acupoint Nerve Stimulator|frequency delivery(3 seconds of 2 Hz followed by 3 seconds of 100 Hz(dense disperse method).
16117254|NCT02033733|Drug|Cisatracurium infusion|"This group will include postcardiac arrest patients that have received a cisatracurium infusion as part of their therapeutic hypothermia protocol. It will only include patients that had their infusion started within 2 hours from protocol initiation. Patients that received an infusion as a rescue measure (beyond the first 2 hours) or did not receive and infusion at all will not be included in this group.
~Most patients admitted to our ICU postcardiac arrest prior to October 2011, will likely belong to this group (the cisatracurium infusion group)."
16117255|NCT02033733|Drug|Cisatracurium prn bolus|Patients that have not received a cisatracurium infusion within the first 2 hours from protocol initiation will be in this group. These are likely to be patients admitted to our ICU after October 2011 (when the protocol change happened).
16117256|NCT02033720|Other|No treatment|No therapeutic hypothermia was induced.
16117257|NCT02033720|Other|Therapeutic hypothermia|Hypothermia was induced after successful resuscitation from cardiac arrest.
16117258|NCT02033707|Drug|Hallucinogens and psychoactive substances|"One of the following or placebo will be given:
~Hallucinogens: DMT, 4-phosphoryloloxy-N-diethyltryptamine, dipropyltryptamine (DPT), ketamine, dextromethorphan, mescaline, PCP, psilocybin, salvinorin-A, LSD, d-lysergic acid amide (LSA), MDMA, cannabis
~Sedatives/anxiolytics: alprazolam, diazepam, lorazepam, secobarbital, temazepam, triazolam, zolpidem
~Antihistamines: diphenhydramine, chlorpheniramine
~Stimulants: d-amphetamine, caffeine, ephedrine, methylphenidate, diethylproprion
~Opioids: heroin, morphine, oxycodone, hydrocodone, methadone, codeine
~Other: alcohol, scopolamine, nicotine
~Each volunteer will receive a hallucinogen on at least one of five sessions. More drugs are listed than will be administered to increase the degree to which volunteers are blind to the drugs being studied. It is important that the volunteer and research staff be blinded to specific drug conditions to minimize confounding the results with expectations about the nature of drug effects."
16117259|NCT02033694|Device|NIRS-IVUS Imaging (TVC Imaging System)|Diagnostic Imaging Catheter
16117260|NCT02033681|Procedure|"One-per-mil Tumescent Solution Injection"|"One-per-mil tumescent solution containing 1:1,000,000 epinephrine concentration in saline solution, is injected to the finger."
16117261|NCT02033681|Procedure|Saline Solution|Saline solution is injected into the tissue as a placebo control.
16117262|NCT02033668|Drug|GSK933776 for SQ administration|Antibody solution for subcutaneous injection with unit dose strength of 50mg/mL administered as 200 mg single dose or as repeat dose of 50 mg weekly for 4 weeks
16117263|NCT02033668|Drug|GSK933776 for IM administration|Antibody solution for intramuscular injection with unit dose strength of 50mg/mL administered as 200 mg single dose
16117264|NCT02033668|Drug|GSK933776 for IV administration|Antibody solution for intravenous injection with unit dose strength of 50mg/mL administered as 200 mg single dose through an IV catheter over approximately 1 hour
16117265|NCT02033655|Dietary Supplement|Protein supplementation|> 30g of high quality protein will be achieved three times a day by subjects in this group, with all or predominantly all from animal source and 60-70% of animal protein from lean pork.
16117266|NCT02033655|Behavioral|Diet counseling and group education lessons|Participants meet once a week for 6 months to participate in group lessons and counseling.
16117267|NCT02033642|Behavioral|Family Based Behavioral Intervention|Family Based Behavioral Intervention (FBBI) is a 24-session lifestyle intervention designed to: (1) educate adolescent/young adult participants and their parents in principles of good nutrition and physical activity, and (2) train parents to implement lifestyle changes at home to facilitate weight loss in their child by monitoring diet and physical activity behaviors, setting goals, providing support and reinforcement, and assessing and making changes to the home environment.
16117268|NCT02033642|Behavioral|Maintenance|The Maintenance condition in this study is a 12-session intervention designed to extend FBBI and continue to teach adolescent/young adult participants and their parents to continue practicing lifestyle behaviors, generalize healthful behaviors to new environments, find additional social and community supports, and prevent and manage relapse.
16117269|NCT02033629|Drug|Ce 1 ng/ml|TCI Remifentanil Ce 1 ng/ml
16117270|NCT02033629|Drug|Ce 2 ng/ml|TCI Remifentanil Ce 2 ng/ml
16117271|NCT02033629|Drug|Ce 3 ng/ml|TCI Remifentanil Ce 3 ng/ml
16117272|NCT02033616|Biological|AVOVA-1|Comparison of a cancer treatment containing autologous dendritic cells loaded with tumor associated antigens (TAA) from autologous self-renewing tumor cells vs. a cancer treatment containing autologous immune cells.
16117273|NCT02033616|Biological|MC|Comparison of a cancer treatment containing autologous dendritic cells loaded with tumor associated antigens (TAA) from autologous self-renewing tumor cells vs. a cancer treatment containing autologous immune cells.
16117274|NCT02033603|Drug|Ropivacaine|30mls of 0.5% ropivacaine
16117275|NCT02033590|Device|Biodegradable (purified) surgical silk scaffold|
16117430|NCT02032277|Drug|Cyclophosphamide|Cyclophosphamide
16117276|NCT02033577|Procedure|Distal gastrojejunal bypass|RYGB with 200 cm BP limb and 150 cm common limb, effect on EWL, QoL and complications
16117277|NCT02033577|Procedure|RYGB|RYGB with 60 cm BP limb and 150 cm alimentary limb, effect on
16117278|NCT02033564|Device|Macintosh/Miller Laryngoscope|
16117279|NCT02033564|Device|Glidescope Laryngoscope|
16117280|NCT02033551|Drug|Veliparib|
16117281|NCT02033551|Drug|Carboplatin|
16117282|NCT02033551|Drug|Paclitaxel|
16117283|NCT02033551|Drug|FOLFIRI|combination of Fluorouracil, leucovorin and irinotecan
16117284|NCT02033538|Drug|nanoparticle albumin-bound paclitaxel|Paclitaxel protein-bound particles for injectable suspension (albumin-bound) 125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle
16117285|NCT02033525|Drug|XCEL-M-ALPHA and standard rehabilitation|Intraarticular infusion of autologous bone marrow derived ex vivo expanded mesenchymal stromal cells produced at Xcelia (Advanced Therapies Division of the Blood and Tissue Bank)
16117286|NCT02033525|Other|Rehabilitation|Standard rehabilitation program
16117287|NCT02033512|Drug|Transdermal Hormone Replacement Therapy|"The Blood samples were collected from the subjects early in the morning after an overnight fast. After serum testing, the identification hormone deficiencies, was determined and then, if necessary, additional transdermal progesterone was prescribed. The patients were evaluated 3 months after THRT treatment protocol.
~All the patients were instructed about how to use the progesterone pump for transdermal application, performed in the presence of an experienced physician, in order to guarantee standardization and correct use of the THRT. Compliance was defined as completing seventy percent or more of the transdermal applications."
16117288|NCT02033512|Drug|Transdermal Nanoformulation|The Blood samples were collected from the subjects early in the morning after an overnight fast. After serum testing, the identification hormone deficiencies, was determined and then, if necessary, additional transdermal hormones were prescribed.
16117289|NCT02033512|Drug|Transdermal formulation|66 patients completed the study. In the present analysis, the subjects received daily in the right and left forearm a transdermal nanostructured formulation of Estriol (0.1%) + Estradiol (0.25%) and Progesterone (10%) respectively (Biolipid B2®, Evidence, SP, Brazil) for sixty months. The effects of transdermal hormone formulation were analyzed.
16117290|NCT02033499|Behavioral|SMBG|Blood glucose levels are tested once daily.
16117291|NCT02033486|Device|TOBI + DBT|
16117292|NCT02033473|Drug|Apelin|An apelin clamp in which an apelin infusion will be administered
16117293|NCT02033473|Drug|Placebo|A clamp reference during which a placebo solution (saline solution) will be administered
16117294|NCT02033460|Other|Manual Therapy and Education|Manual therapy will consist on Traction oscillatory,craniocervical region, Mobilization of upper cervical region in flexion, Side glide roll, Mobilization upper cervical anteroposterior with Wedge, Sliding lateral techniques and High-velocity technique in dorsal region. And Education of the physiology of pain and Education about cognitive behavioral perspective will add to manual therapy treatment.
16117295|NCT02033460|Other|Manual Therapy|Manual therapy will consist on Traction oscillatory, Maintained traction in the craniocervical region, Mobilization of upper cervical region in flexion, Side glide roll, Mobilization upper cervical anteroposterior with Wedge, Sliding lateral C1- C2 ( 2 minutes) , C2 -C3, and C5 -C6 and High-velocity technique in dorsal region.
16117296|NCT02033460|Other|Manual therapy, Education and Exercise|Manual therapy will consist on Traction oscillatory,craniocervical region, Mobilization of upper cervical region in flexion, Side glide roll, Mobilization upper cervical anteroposterior with Wedge, Sliding lateral techniques and High-velocity technique in dorsal region. And Education of the physiology of pain and Education about cognitive behavioral perspective and Craniocervical exercise will add to this arm.
16117297|NCT02033447|Other|Magnetic Nanoparticle Injection|
16117298|NCT02033434|Drug|Intranasal Ketamine|Atomized Intranasal Ketamine, 50mg
16117299|NCT02033408|Drug|AB (antibiotics)|"PO Vancomycin 250mgX4/d for 3 weeks
~PO Amoxycillin 50mg/Kg divided by 3 (up to 500mgX3/d) - for 3 weeks
~PO Doxycycline 2mg/kg X2/d (up to 100mgX2/d) - for 3 weeks; OR- For children younger than 8 years: PO Ciprofloxacin 10mg/Kg X2/2 (up to 250mgX2/d) for 3 weeks
~Patients with known allergy to one of the drugs may be treated with oral Gentamycin (2.5mg/KgX3/d) for 3 weeks instead of the allergenic drug."
16117300|NCT02033408|Drug|CS (corticosteroids) Only|"methylprednisolone (1.5mg/kg up to 60mg daily in two divided doses)
~PO Metronidazole 5mg/Kg X3/d (up to 250mgX3/d) - for 3 weeks"
16117301|NCT02033369|Drug|Pramipexole|Dose will be started at 0.125 mg bid, and increased by 0.25 mg/day every 3-4 days to a target range of 1.0 - 2.5 mg/day.
16117302|NCT02033356|Procedure|Adductor canal block with lidocaine 1%|US-guided adductor canal block
16117303|NCT02033356|Drug|Lidocaine|
16117304|NCT02033343|Radiation|Prostate cancer radiotherapy using real-time tracking|Radiotherapy delivered using Calypso radiofrequency emitting beacon guided real-time prostate localisation and beam adjustment using Dynamic Multi-leaf Collimator tracking software.
16117305|NCT02033330|Dietary Supplement|phenolics form orange peel|
16117306|NCT02033317|Drug|patiromer|15 grams/day (5 grams 3 times daily) administered orally
16117307|NCT02033291|Procedure|Dynamic contrast enhanced Brain MRI|DCE-MRI is used to quantify the BBB permeability
16117308|NCT02033278|Drug|Infusion of autologous mononuclear bone marrow cells|Infusion of autologous mononuclear bone marrow cells plus conventional medical treatment (as indicated by clinician)
16117309|NCT02033278|Drug|Placebo infusion|Placebo infusion plus conventional medical treatment (as indicated by clinician)
16117310|NCT02033265|Procedure|Brachial plexus block|Ultrasound guided axillary brachial plexus block
16117311|NCT02033252|Device|Acupuncture|In the acupuncture treatment group, 10 acupuncture points (bilateral LI4, TE23, ST36, unilateral EHN-1, GV23, LI20 and LI4) will be inserted with 0.20 mm in diameter x 30 mm in length disposal needles. The needle will be inserted to a depth of 10 - 30 mm, according to the points selected. The participating acupuncture doctors will manually manipulate the acupuncture needles with de-qi sensation and maintain the needles for 10 minutes with two times of manual stimulation, at the beginning and at the end.
16117312|NCT02033239|Drug|Faster-acting insulin aspart|Subjects will receive different dose levels of faster acting insulin aspart and NovoRapid®. Single dose of trial products will be administered subcutaneously (s.c. under the skin).
16117431|NCT02032277|Drug|Placebo|Placebo for Carboplatin
16117432|NCT02032277|Drug|Doxorubicin|Doxorubicin
16117313|NCT02033239|Drug|insulin aspart|Subjects will receive different dose levels of faster acting insulin aspart and NovoRapid®. Single dose of trial products will be administered subcutaneously (s.c. under the skin).
16117314|NCT02033226|Device|Amniotic Membrane|AM strongly resembles the oral mucosal basement membrane and possesses several types of laminins, which can promote regeneration, accelerate tissue adhesion, and preserve tissues, all of which play a key role in improved healing of periodontal lesions and might result in reduction in probing pocket depth (PPD) and decrease in clinical attachment loss (CAL)
16117315|NCT02033226|Device|Control group (Hydroxyapatite only)|The placebo group was treated with Hydroxyapatite graft placement only.
16117316|NCT02033213|Other|Restrictive group|"A group of patients who received ≤ 8ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.
~The fluid administered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
16117317|NCT02033213|Other|Liberal group|"A group of patients who received > 8 ml/kg/h of intraoperative fluid during esophageal carcinoma surgery.
~The fluid admnistered: Plasma-Lyte 148 (pH 7.4; Viaflo, Baxter, US), 10% Aminoven (Fresenius Kabi AG, Bad Homburg, Germany) at 0.5 ml/kg/h, 5 ml/kg of colloid (6% Voluven 130/0.4, Fresenius Kabi AG, Bad Homburg, Germany), packed red blood cells."
16117318|NCT02033200|Drug|Stendra 200 mg|
16117319|NCT02033200|Drug|Placebo|
16117320|NCT02033187|Other|Chlorhexidine bathing|Patients in an ICU randomized to treatment arm 1 will be bathed with single use, no rinse, disposable cloths impregnated with 2% chlorhexidine gluconate solution (Sage® 2% Chlorhexidine Gluconate Cloths). Bathing of the skin of the arms, chest, abdomen, back, both legs, perineum, and buttocks will be performed daily and as needed after patients become soiled. The face and neck will not be bathed in this manner but will be bathed with water-moistened washcloths. All other infection control and cleaning procedures will be performed per the current practice in each intensive care unit.
16117321|NCT02033187|Other|Non-chlorhexidine bathing|Patients in an ICU randomized to treatment arm 2 will be bathed with single use, no rinse, disposable cloths that do not contain chlorhexidine gluconate solution (Sage Comfort Bath® Cleansing Washcloths). Bathing of the skin of the arms, chest, abdomen, back, both legs, perineum, and buttocks will be performed daily and as needed after patients become soiled. The face and neck will not be bathed in this manner but will be bathed with water-moistened washcloths. All other infection control and cleaning procedures will be performed per the current protocols in each intensive care unit.
16117322|NCT02033174|Other|Oral fat diet plus water with sugar|All participants were assigned to receive and oral fat diet plus sugar water. Oral fat diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat. Sugar water has equivalent caloric intakes as alcoholic beverages.
16117323|NCT02033174|Other|Oral fat diet plus alcoholic beverages|Oral fat diet contained 1487 kcal/m2 with 654 kcal/m2 (44%) as fat. In all cases, alcohol represented a daily total amount of 16 g/m2. The content of alcohol was 12% in red wine, 37% in rum, and 35% in brandy.Vodka was tri-distilled and contained 40% alcohol.
16117324|NCT02033161|Behavioral|Internet-delivered CBT|"The internet-treatment consisted of six modules during 8 weeks. Part 1: education about FGID and the treatment model. Part 2: individual symptom behavior. Part 3: toilet habits, or other common symptom behavior. Part 4 and Part 5: Exposure during 4 weeks. Part 6: relapse prevention.
~Parents received four modules over 8 weeks consisting of psycho-education about FGID and the treatment model, increased positive time with the child in order to reduce attention to pain, parental symptom behavior, support child exposure and relapse prevention.
~The therapists gave feedback weekly . All participants had at least 1 telephone call from their therapist during the fifth and sixth week of treatment."
16117325|NCT02033148|Drug|icotinib hydrochloride|Given PO
16117326|NCT02033148|Other|laboratory biomarker analysis|Correlative studies
16117327|NCT02033148|Other|pharmacological study|Correlative studies
16117328|NCT02033135|Procedure|Angioplasty with Zilver PTX|Angioplasty and stenting with a polymer free paclitaxel-eluting stent (Zilver-PTX)
16117329|NCT02033135|Other|Best medical treatment|Treatment with antiplatelet and statins, smoking cessation advice and unsupervised walking exercise.
16117330|NCT02033135|Device|Zilver PTX|
16117331|NCT02033122|Other|Aerobic training|the intervention will be an aerobic training program. For the TG subjects, breathing exercises will have duration of 30 minutes and will be always followed by aerobic training sessions that will consist in 35 minutes divided in 5 minutes of warm-up, 25 minutes of aerobic training and 5 minutes of cool down. Initially, aerobic training will be performed at the heart rate (HR) corresponding to one third of the difference between the anaerobic threshold (AnT) and the respiratory compensation point (RCP) obtained in the incremental cardiopulmonary testing (CPET) and after two weeks of the adaptation, the intensity will increased to two thirds of the difference between AnT and RCP. The program will be performed twice a week, for 3 months.
16117332|NCT02033122|Other|Breathing exercise|Patients from the control group will be taught breathing exercises with 30 min per session , twice a week , during 3 months. Every exercise will be performed in sets of 3 (2 min each) and 60 s of rest .
16117333|NCT02033109|Drug|PC-1005|Intravaginal use
16117334|NCT02033109|Drug|HEC gel|
16117335|NCT02033096|Drug|Stannsoporfin|No intervention was administered during this observational study
16117336|NCT02033096|Drug|Placebo Control|No intervention was administered during this observational study
16117337|NCT02033096|Other|Phototherapy (as needed)|No intervention was administered during this observational study
16117338|NCT02033083|Device|Laminaria|
16117339|NCT02033083|Device|Dilapan-S|
16117340|NCT02033057|Procedure|Muscular electrostimulation and percutaneus muscular biopsy.|Muscular electrostimulation everyday and percutaneus muscular biopsy weekly.
16117341|NCT02033044|Other|cognitive remediation|Cognitive Rehabilitation (CR). Consisted on group sessions (5 individuals per group) of 120-minutes, twice a week during a total period of 16 weeks (32 sessions). The exercises addressed neurocognitive issues related to sustained attention, processing speed, memory and executive functioning. The whole program aimed at getting new strategies to improve functional adaptation, thus tasks were carried out in the clinical setting and at home. Some homework tasks were based on their daily life difficulties and problems. The main objective of this program was the generalization of rehabilitated cognitive functions to daily life activities. Most of the techniques were based on a previous program for bipolar disorder.
16117342|NCT02033044|Other|Psychoeducation|Psychoeducation (PE). The psychoeducation intervention consisted of 16 weekly group sessions of 5 individuals of 120 minutes each (16 sessions). This therapy aimed at improving illness' consciousness , interpersonal abilities, family balance, therapeutical adherence, emotional management in frustrating situations, problems resolutions, and lifestyle regularity. On this intervention, no homework tasks were required. This intervention was based on the Systems Training for Emotional Predictability and Problem Solving (STEPPS) program therapy.
16117343|NCT02033031|Drug|Lucentis intravitreal injection|Lucentis intravitreal injection
16117344|NCT02033031|Drug|Avastin intravitreal injection|Avastin intravitreal injection
16117345|NCT02033018|Drug|Aflibercept Injection|Aflibercept intravitreal injection
16117346|NCT02032979|Behavioral|Psychiatric test|
16117347|NCT02032966|Procedure|Nonsurgical|"Randomized to nonsurgical: patient will receive surgical treatment of the inside portion (medial malleolus) of the tibia fracture only; the fibula fracture (and posterior malleolus fracture, if present) will be closed reduced (not repaired surgically)."
16117348|NCT02032966|Procedure|Surgical|"Randomized to surgical: patient will receive surgical treatment of both the inside portion (medial malleolus) of the tibia fracture, as well as the fibula fracture (lateral malleolus). Fixation of the posterior side of the tibia (posterior malleolus) may or may not be performed based upon intraoperative x-rays."
16117349|NCT02032953|Dietary Supplement|Travasol (amino acid injection)|an amino acid supplementation infused intravenously containing essential and non-essential amino acids
16117350|NCT02032953|Drug|Insulin|After the insertion of an arterial catheter and obtaining a baseline arterial blood glucose value, 2 units of insluin will be administered iv followed by an infusion of 2 microunits/kg*min. Ten minuts after starting the insulin, and when the the blood glucose is<6 mmol/L, dextrose 20% supplemented with phosphate (30mmol/L) will be infused. Blood glucose levels measured every 15 minutes and the dextrose infusion rate adjusted to maintain arterial glycemia between 4 and 6 mmol/L until end of study.
16117351|NCT02032927|Drug|Codeine/paracetamol|"Randomization to one of the two treatments will be done through appropriate randomization list.
~During the first 15 days of treatment in the event of failure of efficacy, understood as the average pain intensity higher than 4 (monitored with NRS) with the need to take more than two rescue doses of paracetamol per day, and in the absence of side effects, the patients will be instructed on how to proceed with dosage adjustments according to specific guidelines.
~The patient will be evaluated at 15 days, 1 month, 2 months and three months. Your health care professional who administer the assessment scales (WOMAC, SF-12, BFI, TMT) will not know in any way which treatment the patient is taking."
16117352|NCT02032927|Drug|Oxycodone/naloxone|"Randomization to one of the two treatments will be done through appropriate randomization list.
~During the first 15 days of treatment in the event of failure of efficacy, understood as the average pain intensity higher than 4 (monitored with NRS) with the need to take more than two rescue doses of paracetamol per day, and in the absence of side effects, the patients will be instructed on how to proceed with dosage adjustments according to specific guidelines.
~The patient will be evaluated at 15 days, 1 month, 2 months and three months. Your health care professional who administer the assessment scales (WOMAC, SF-12, BFI, TMT) will not know in any way which treatment the patient is taking."
16117353|NCT02032901|Drug|Daclatasvir|
16117354|NCT02032901|Drug|Sofosbuvir|
16117355|NCT02032888|Drug|Daclatasvir|
16117356|NCT02032888|Drug|Sofosbuvir|
16117357|NCT02032875|Drug|Daclatasvir|
16117358|NCT02032875|Drug|Sofosbuvir|
16117359|NCT02032875|Drug|Ribavirin|
16117360|NCT02032862|Drug|Sage extract, 3400 mg , DER 1:17|
16117361|NCT02032849|Procedure|Manual air-impingement operation|A method which we invented to clear subglottic secretion
16117362|NCT02032849|Device|subglottic secretion drainage|The conventional method with a special tube to drainage subglottic secretion
16117363|NCT02032836|Drug|lloprost(Ventavis,BAYQ6252, 20 µg/mL)|20 µg/mL iloprost nebulizer solution, inhaled with FOX nebulizer
16117364|NCT02032836|Drug|lloprost(Ventavis,BAYQ6252, 10 µg/mL)|10 µg/mL iloprost nebulizer solution, inhaled with I-Neb nebulizer
16117365|NCT02032823|Drug|Olaparib|Patients will be administred olaparib orally twice daily (b.i.d.) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 ml of water.
16117366|NCT02032823|Drug|Placebo|Patients will be administred matching placebo. Two (2) tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 ml of water.
16117367|NCT02032810|Drug|Panobinostat|Participants will be assigned to receive a certain dose of panobinostat (5, 10, 15, or 20 mg). The dose of panobinostat will depend on the time point the participant enters the study and the side effects of other participants already on the study.
16117368|NCT02032810|Drug|Ipilimumab|Dose of ipilimumab of 3 mg per kg (mg/kg) of body weight.
16117369|NCT02032797|Drug|Progesterone|
16117370|NCT02032784|Drug|octreotide|Octreotide 100mg subcutaneous every 8 hours for 5 days
16117371|NCT02032784|Other|No Octreotide|No drug
16117372|NCT02032771|Device|M22 IPL and ResurFX|The procedure will include an intense pulse light (M22 IPL) treatment followed by fractional non-ablative (M22 ResurFX) treatment.
16117373|NCT02032758|Drug|Propranolol|Single oral dose of 10 mg propranolol
16117374|NCT02032758|Device|Opal Device|The Opal Device (APDM, Inc.) will be used to measure wrist movement.
16117375|NCT02032758|Procedure|Science and Motion PuttLab (SAM)|The SAM will be used to study putter stroke movement and ball movement.
16117376|NCT02032758|Device|Surface Electromyography EMG|The surface EMG will be used to evaluate co-contraction of the wrist flexor/extensor muscle groups and the wrist pronator/supinator muscle groups.
16117377|NCT02032732|Other|leukocyte esterase test|leukocyte esterase test on fluid removed by intra-articular aspiration
16117378|NCT02032719|Behavioral|smartphone-assisted health coaching|smartphone with software provides self monitoring of exercise, diet and stress reduction; provision of timely reminders; photo-journaling of meals; secure text messaging
16117379|NCT02032719|Behavioral|Lifestyle counseling|Lifestyle counseling
16117380|NCT02032706|Device|Deliver therapy when the supine position is detected|Application of vibrotactile feedback to the neck when the supine position is detected
16117381|NCT02032693|Dietary Supplement|Everycell™|
16117383|NCT02032680|Behavioral|Web-based multi-family psychoeducational treatment|This intervention uses a website to provide multi-family psychoeducational treatment to Veterans and their family members or other supporters.
16117384|NCT02032680|Behavioral|In-persons Multi-Family Group Psycho-Education treatment|This intervention will provide the VA's evidence-based MFG. This intervention is delivered to Veterans and their families or other supporters using an in-person format.
16117385|NCT02032680|Other|Treatment as usual (TAU)|Treatment as Usual (TAU) is considered the usual care at the VA. Participants assigned to be in the Treatment as Usual arm will complete assessments at all data collection time points, (baseline, 6, 12, and 15 months.) These participants will not receive any study treatment but will continue to receive their treatment as usual through the VA.
16117386|NCT02032667|Behavioral|Multi-player condition|Children in the multi-player condition will be able to play with and compete against other children in real time.
16117387|NCT02032654|Drug|Flucloxacillin|
16117388|NCT02032654|Drug|Placebo (for flucloxacillin)|Sugar capsule manufactured to mimic flucloxacillin 500mg capsules
16117389|NCT02032641|Device|Laser treatment|Non-ablative, non-fractional, microsecond-pulsed Nd:YAG laser 500-1000 pulses, 0.3 msec pulse duration, 10-14 J/cm2, 5 mm spot size
16117390|NCT02032628|Behavioral|Exercise|The investigators will measure changes in DNA methylation as a result of four different intervention groups, i.e, high/longer, low/longer, high/shorter, low/shorter.
16117391|NCT02032615|Dietary Supplement|Education plus Gudness Nutritional Bar|
16117392|NCT02032615|Other|Education|
16117393|NCT02032602|Other|Deep Dry Needling|
16117394|NCT02032589|Behavioral|Self-generation treatment|self-generation treatment is a cognitive rehabilitation strategy aimed to improve memory. The self-generation strategy treatment, embedded within practice of various activities will consists of six individualized intervention sessions administered over 2-3 weeks
16117395|NCT02032576|Device|ECT for depressed patients|electroconvulsive therapy with a bipolar brief pulse square wave
16117396|NCT02032563|Drug|Indocyanine Green|intravenous injection of 0.25mg/kg Indocyanine Green just before the surgery
16117397|NCT02032550|Other|Preference Based Decision Aid|The objective of the preference based decision aid is to assess the treatment preferences of prostate cancer patients. The investigators will analyze the association between preferences, treatment choice and objective and subjective outcomes. The preference based decision aid will lead to a values-based patient centered treatment decision making. This will ultimately improve clinical decision making, clinical policy process, enhance patient centered care and improve prostate cancer outcomes.
16117398|NCT02032537|Drug|Callmax cream application over affected skin|Callmax cream application over affected skin Callmax cream or topical water containing emollient (placebo) will be applied by the patient on the affected skin area whenever the pruritus starts including night time. The frequency of application will be regulated by individual patients and increased according to pruritus severity.
16117399|NCT02032537|Drug|Placebo|Topical water containing emollient (placebo) will be applied by the patient on the affected skin area whenever the pruritus starts including night time. The frequency of application will be regulated by individual patients and increased according to pruritus severity. The data on efficacy, duration of effect and frequency of application will be collected.during the study.
16117400|NCT02032524|Drug|GZ402666|Pharmaceutical form: lyophilized powder reconstituted for infusion Route of administration: intravenous
16117401|NCT02032498|Drug|Indocyanine Green|Superficial injection of ICG in combination with deep injection of 99mTc-HSA to evaluate the complementarity of the two techniques
16117402|NCT02032485|Drug|Indocyanine Green|An iv injection will be performed for the colorectal cancer patient before the operation.
16117403|NCT02032472|Other|Measurement of Arterial Pressure|Pharmacies cooperate in measuring blood pressure of patients
16117404|NCT02032446|Biological|UMBILICAL CORD DERIVED MESENCHYMAL STROMAL CELLS (UC-MSC)|"pentostatin, dose 1 mg/m2
~§ MSC doses:
~3 patients → 3 infusions of 1x106 cells /kg
~3 patients → 3 infusions of 2x106 cells /kg
~3 patients → 3 infusions of 3x106 cells /kg"
16117405|NCT02032433|Drug|Extended-Release Naltrexone|Extended-Release Naltrexone (Vivitrol®)
16117406|NCT02032433|Drug|Buprenorphine-Naloxone|Buprenorphine-Naloxone (Suboxone®)
16117407|NCT02032420|Behavioral|STAR|
16117408|NCT02032420|Behavioral|ART|
16117409|NCT02032407|Drug|Dapsone Gel|Dapsone Gel (Aczone®) applied twice daily to the face for 12 weeks.
16117410|NCT02032394|Drug|Povidone-iodine|15 ml 10%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters
16117411|NCT02032394|Drug|Chlorhexidine|15 ml .2%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters
16117412|NCT02032394|Drug|Normal saline|15 ml .9%, 3 imes a day for 10 days /external use for Washing perinea area and catheter first 5 centimeters
16117413|NCT02032381|Other|late pulmonary complications occurring in children treated with allogeneic hematopoietic stem cells.|
16117414|NCT02032368|Procedure|transarterial chemoembolization (TACE)|
16117415|NCT02032355|Procedure|spinal anesthesia|
16117416|NCT02032342|Device|Endobronchial double lumen tube|Endobronchial double lumen tube for one lug ventilation
16117417|NCT02032342|Device|Arndt® blocker|Arndt® blocker for selective lobar deflation
16117418|NCT02032342|Device|Cohen blocker|Cohen blocker for selective lobar deflation
16117419|NCT02032342|Device|Fuji Uni-blocker|Fuji Uni-blocker foe selective lobar deflation
16117420|NCT02032329|Device|FastFES|Fast treadmill walking supplemented with FES to ankle plantarflexor and dorsiflexor muscles, using a VFT stimulation pattern. 12 weeks of 2-3x/week. Stimulation delivered using the customKYnetics study device.
16117421|NCT02032316|Device|Post-Ureteroscopy ADVA-Tec Uriprene™ Degradable Temporary Ureteral Stent|Renal stent placed after uncomplicated uteroscopy
16117422|NCT02032303|Procedure|Assessment of coronary flow reserve|
16117423|NCT02032303|Procedure|Percutaneous Coronary Intervention|
16117424|NCT02032303|Drug|Ticagrelor loading|
16117425|NCT02032303|Drug|Prasugrel loading|
16117426|NCT02032290|Procedure|Assessment of Coronary Flow Reserve|
16117427|NCT02032290|Procedure|Percutaneous coronary intervention|
16117428|NCT02032290|Drug|ticagrelor loading|
16117429|NCT02032290|Drug|Clopidogrel loading|
16117437|NCT02032264|Other|Comprehensive Chromosome Screening|On day 6 of embryo development, all embryos will undergo a trophectoderm biopsy using the standardized technique, as according to standard laboratory protocol and without regard to study. Comprehensive Chromosome Screening (CCS), will be performed via next generation sequencing and results will be available at the time of study completion.
16117438|NCT02032264|Other|Morphologically Best|Patients in this arm of the study will not receive CCS in selection of their embryo for transfer. The best looking embryo (morphology) will be transferred
16117439|NCT02032251|Drug|oral administration of ginger|Oral administration of ginger in patients with infertility.
16117440|NCT02032251|Drug|Placebo|
16117441|NCT02032238|Device|laser photocoagulation|Standard bevacizumab Injections will be combined with laser photocoagulation in a pre-defined manner
16117442|NCT02032225|Other|Skin biopsy|
16117443|NCT02032212|Other|EVP unflavoured|
16117444|NCT02032212|Other|EVP flavoured|
16117445|NCT02032212|Other|Nicotine inhalator|15 mg nicotine Nicorette
16117446|NCT02032212|Other|Conventional cigarette|
16117447|NCT02032186|Drug|Magnesium citrate|Oral Mg++citrate, 160 mg twice daily. Each capsule will contained 160 mg of elemental magnesium citrate. The participants will be instructed to take one capsule twice daily until delivery.
16117448|NCT02032173|Drug|Ranibizumab 0.5mg|Intravitreal injection with standard dose of 0.5 mg/0.05mL Pro re nata (PRN)
16117449|NCT02032160|Biological|Engerix B IM injection - 20ug|Engerix B IM injection - 20ug At 0, 1 and 6 months
16117450|NCT02032160|Biological|Fendrix IM injection - 20ug|Fendrix IM injection - 20ug At 0, 1 and 6 months
16117451|NCT02032147|Drug|NGF group|This group will be treated with NGF 18u per day im for 60 days
16117452|NCT02032134|Biological|Transfusion of Pooled Platelets Cryopreserved In DMSO|"Patients with severe thrombocytopenia will be admitted as in patients at the Hematology Unit of the Policlinic P. Giaccone- Palermo, if they require platelet transfusion (for bleeding, in preparation for surgery, after chemotherapy); they will receive buffy coat derived cryopreserved platelets,after thawing"
16117453|NCT02032121|Procedure|Blood specimen|
16117454|NCT02032121|Procedure|Echocardiography|
16117455|NCT02032108|Behavioral|lifestyle counselling|"A 45-min lifestyle educational session will be delivered to the subjects randomized to the intervention group every month for one year.
~Lifestyle intervention will consist in group counselling on dietary habits, effects of regular physical activity, importance of adherence to medications, diabetes complications, actions to control blood sugar and ways of coping with stress."
16117456|NCT02032095|Drug|GB-0998|
16117457|NCT02032082|Other|Carbone monoxide|
16117458|NCT02032069|Other|no intervention|
16117459|NCT02032056|Dietary Supplement|Probiotic (10^9 CFU/day)|
16117460|NCT02032056|Dietary Supplement|Probiotic (10^8 CFU/day)|
16117461|NCT02032056|Other|Placebo|
16117462|NCT02032043|Drug|Annual versus Semiannual Albendazole plus Ivermectin MDA|Annual or semiannual Albendazole plus Ivermectin, administered by the Ivorian Ministry of Health.
16117463|NCT02032017|Procedure|Ceramic on ceramic couple|All patients will get a standard total hip replacement (cementless hydroxyapatite coated cup and a titanium plasmasprayed stem) with a ceramic on ceramic (third generation biolox delta) couple. Preoperative leg length and offset are marked to reconstruct the preoperative leg length and to obtain the optimal offset.
16117464|NCT02032017|Procedure|Percutaneous assisted approach|
16117465|NCT02032017|Procedure|Anterolateral approach|
16117466|NCT02032017|Other|Usual care|Both groups will receive usual care (UC) after surgery. This includes standard physiotherapy care consisting of mobilizing and strengthening techniques. All patients will receive a booklet containing information about the surgery, weight bearing after the surgery, and rehabilitation in general.
16117467|NCT02032004|Biological|Allogeneic Mesenchymal Precursor Cells (MPC)|Rexlemestrocel-L consists of human bone marrow-derived allogeneic MPCs isolated from bone mononuclear cells with anti-STRO-3 antibodies, expanded ex vivo,and cryopreserved
16117468|NCT02032004|Other|Sham Comparator|The sham procedure will be staged to script and will not include actual cardiac mapping or delivery of rexlemestrocel-L.
16117469|NCT02031991|Biological|PF-06439535|Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.
16117470|NCT02031991|Biological|Avastin|Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.
16117471|NCT02031991|Biological|Avastin|Solution for intravenous infusion, single dose of 5mg/kg, administered as 90-minute infusion.
16117472|NCT02031965|Biological|oncolytic HSV-1716|Given IT
16117473|NCT02031965|Drug|dexamethasone|Given IV
16117474|NCT02031965|Procedure|therapeutic conventional surgery|Undergo surgical resection
16117475|NCT02031965|Other|laboratory biomarker analysis|Correlative studies
16117476|NCT02031952|Procedure|hepatectomy combined with lymphadenectomy|
16117477|NCT02031952|Procedure|hepatectomy alone|
16117478|NCT02031939|Drug|Induction and gap chemotherapy (Capecitabine combine with oxaliplatin)|All rectal cancer patients in this group will receive induction, gap chemotherapy(capecitabine combine with oxaliplatin) alone with standard chemoradiotherapy before surgery.
16117479|NCT02031939|Radiation|standard chemoradiotherapy|All rectal patients in this group will receive standard chemoradiotherapy and surgical resection.
16117480|NCT02031926|Device|Positive expiratory pressure|
16117481|NCT02031900|Device|NvisionVLE Imaging System: NvisionVLE Imaging Console, NvisionVLE Optical Probe and Inflation Accessory Kit|The NvisionVLE Imaging System is indicated for use as an imaging tool in the evaluation of human tissue microstructure, including esophageal tissue microstructure, by providing two-dimensional, cross-sectional, real-time depth visualization.
16117482|NCT02031887|Dietary Supplement|formula with synbiotics|
16117483|NCT02031887|Dietary Supplement|formula without synbiotics|
16117484|NCT02031861|Drug|nifedipine CR tablets (Xin Ran)|
16117485|NCT02031861|Drug|nifedipine CR tablets (Adalat)|
16117486|NCT02031848|Other|Diet Intervention|
16117487|NCT02031848|Other|Assessments and Diet Intake|
16117488|NCT02031835|Procedure|BWSTT (3 days a week for maximum of 20 minutes session)|
16117725|NCT02030002|Device|APC II Adhesive Coated Appliance System|APC II Adhesive Coated Appliance System
16117489|NCT02031822|Procedure|US-guided Greater Occipital Nerve Injection|Medication injected around the greater occipital nerve: 2ml 0.5% bupivacaine with epinephrine 1:200,000 and Depo-Medrol 40mg.
16117490|NCT02031796|Other|CAVAREC Image Processing algorithm|After deployment of the TAVI prosthesis, other trans catheter valve, or stent, but before the patient care episode is completed, a set of rotational x-ray angiography images will be acquired and reconstructed using the clinical DyanCT and research CAVAREC algorithms.
16117491|NCT02031783|Dietary Supplement|Mixture of glucose and fructose|
16117492|NCT02031783|Dietary Supplement|glucose|
16117493|NCT02031770|Drug|Sodium bicarbonate|Subjects will be treated with oral sodium bicarbonate two to three times per day for a goal serum bicarbonate (HCO3-) of ≥ 23 meq/L.
16117494|NCT02031770|Other|Control|subjects will receive no treatment
16117495|NCT02031757|Other|perturbation training|training utilizing a system that provides small, controlled and unpredictable perturbations during treadmill walking.
16117496|NCT02031757|Other|balance exercises|specific exercises regularly used in rehabilitation aiming to improve balance
16117497|NCT02031744|Drug|erlotinib [Tarceva]|150 mg oral administration once daily
16117498|NCT02031744|Drug|Placebo|15 mg/kg intravenous administration every 3 weeks
16117499|NCT02031744|Drug|Onartuzumab [MetMAb]|15 mg/kg intravenous administration every 3 weeks
16117500|NCT02031731|Drug|4 mg/kg Onartuzumab (MetMAb)|4 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks.
16117501|NCT02031731|Drug|15 mg/kg Onartuzumab (MetMAb)|15 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks.
16117502|NCT02031731|Drug|30 mg/kg Onartuzumab (MetMAb)|30 mg/kg Onartuzumab (MetMAb) will be administered intravenously every 3 weeks.
16117503|NCT02031718|Behavioral|Virtual Counseling|
16117504|NCT02031705|Procedure|cavotricuspid isthmus ablation|Isthmus ablation was performed in paroxysmal atrial fibrillation patients.
16117505|NCT02031705|Procedure|control group|Control group was performed no additional cavotricuspid isthmus ablation.
16117506|NCT02031692|Drug|400IU cholecalciferol and 500mg of elemental calcium as calcium carbonate|The patients allocated to the intervention group will have a test for serum vitamin D, and receive 800 IU of vitamin D and 1000 mg of calcium as calcium carbonate when the serum vitamin D is decreased. The patients in the control group will be followed up without intervention for one year.
16117507|NCT02031679|Drug|AZD1981|AZD1981 is an oral, potent, selective, reversible antagonist of CRTh2 (Chemoattractant Receptor Homologous Molecule expressed on Th2 cells).
16117508|NCT02031679|Drug|Placebo|Sugar pill manufactured to mimic AZD1981 10 mg tablet
16117509|NCT02031666|Drug|JNJ-56021927 capsule|Participants will receive oral soft gel capsules providing a total dose of 240 mg JNJ-56021927 on Day 1.
16117510|NCT02031666|Drug|JNJ-56021927 tablet|Participants will receive oral tablets providing a total dose of 240 mg JNJ-56021927 on Day 1.
16117511|NCT02031640|Drug|Beclomethasone dipropionate|
16117512|NCT02031640|Drug|Placebo|
16117513|NCT02031640|Drug|Albuterol/salbutamol|Rescue medication (albuterol/salbutamol hydrofluoroalkane (HFA) MDI [90 mcg ex-actuator] or equivalent) for use on an as-needed basis for the immediate relief of asthma symptoms throughout the treatment period.
16117514|NCT02031627|Device|pneumatic compression - 1 hour per day|Pneumatic compression treatment once per day (1 hour)
16117515|NCT02031627|Device|pneumatic compression - 2 hours per day|pneumatic compression treatment twice per day in the AM & PM (2 hours)
16117516|NCT02031627|Device|pneumatic compression - 4 hours per day|pneumatic compression treatment twice per day consisting of 2 consecutive 1 hour treatments in the AM & PM (4 hours)
16117517|NCT02031614|Procedure|Phlebotomy|Withdrawal of 500 mL of whole blood.
16117518|NCT02031601|Drug|Erlotinib|150mg po once a day on days 2-15 of each 3 week cycle for 4 cycles; then continue to receive erlotinib150mg po once a day daily until progression
16117519|NCT02031601|Drug|Gefitinib|250mg po once a day on days 2-15 of each 3 week cycle for 4 cycles; then continue to receive gefitinib 250mg po once a day daily until progression
16117520|NCT02031601|Drug|Icotinib|125mg po three time a day on days 2-15 of each 3 week cycle for 4 cycles; then continue to receive icotinib 125mg po three time a day daily until progression
16117521|NCT02031601|Drug|Docetaxel|75 mg/m2 ivgtt on days 1 of each 3 week cycle for 4 cycles
16117522|NCT02031601|Drug|Pemetrexed|500 mg/m2 ivgtt on days 1 of each 3 week cycle for 4 cycles
16117523|NCT02031601|Drug|Platinum (cisplatin or carboplatin)|cisplatin -- 75mg/m2 ivgtt on day 1 of each 3 week cycle for 4 cycles or carboplatin -- 5 x AUC ivgtt on day 1 of each 3 week cycle for 4 cycles
16117524|NCT02031601|Drug|Erlotinib|150mg po once a day daily until disease progression
16117525|NCT02031601|Drug|Gefitinib|250mg po once a day daily until disease progression
16117526|NCT02031601|Drug|Icotinib|125mg po three times a day daily until disease progression
16117527|NCT02031575|Behavioral|Interactive Treatment|Mobile phone text messaging service about reproductive health
16117528|NCT02031575|Behavioral|Basic Treatment|Mobile phone text messaging service about reproductive health
16117529|NCT02031575|Other|Control, comparator arm|
16117530|NCT02031562|Other|chiropractic|chiropractic
16117531|NCT02031562|Other|physical therapy|physical therapy
16117532|NCT02031549|Other|SpermComet assay|Measurement of DNA fragmentation in samples of surplus sperm (diagnostic, not an intervention).
16117533|NCT02031536|Drug|everolimus|Given PO
16117534|NCT02031536|Other|placebo|Given PO
16117535|NCT02031523|Drug|Sanjie analgesic capsule|Oral, four each time, 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle.or follow the doctor's advice.
16117536|NCT02031523|Drug|placebo|oral，four each time, 3 times a day, on the first day of menstruation to start taking, taking three consecutive menstrual cycle. Or Follow the doctor's advice.
16117537|NCT02031510|Drug|placebo|transversus abdominis plane block with saline 0.9%
16117538|NCT02031510|Drug|bupivacaine|transversus abdominis plane block bupivacaine 0.25%
16117539|NCT02031510|Drug|bupivacaine-dexmedetomidine|transversus abdominis plane block with bupivacaine 0.25% with dexmedetomidine 1 µg Kg-1
16117726|NCT02029989|Device|Glucose and lipids|"Point-of-care (POCT) screening for diabetes and dyslipidemia.
~Glucose and Lipids"
16117540|NCT02031497|Dietary Supplement|Drink with sweeteners|Subjects will have to consume a 330ml can of a drink with sweeteners twice per day as part of their usual fluid intake for 12 weeks.
16117541|NCT02031497|Dietary Supplement|Drink without sweeteners|Subjects will have to consume a 330ml can of a drink without sweeteners twice per day as part of their usual fluid intake for 12 weeks.
16117542|NCT02031471|Drug|tocilizumab|Fixed dose of 162 mg subcutaneously weekly
16117543|NCT02031458|Drug|Atezolizumab|1200 mg IV every 3 weeks
16117544|NCT02031445|Drug|MRX-6|
16117545|NCT02031445|Other|Placebo|
16117546|NCT02031432|Drug|Cebranopadol|Film-coated tablet; strengths: 200, 400, or 600 µg
16117556|NCT02031406|Other|Post-discharge counseling on medication adherence & literacy|
16117557|NCT02031380|Device|Open angle glaucoma - iDropper device|The iDropper system is an eye drop dispensing device and medication monitor designed to optimize adherence behaviors for glaucoma patients.
16117558|NCT02031367|Drug|Triamcinolone Acetonide|Corticosteroid arm
16117559|NCT02031367|Other|Platelet Rich Plasma|Platelet Rich Plasma
16117560|NCT02031354|Dietary Supplement|Lysine Chloride|Administration of 21g of lysine chloride (7g three times daily) for a period of time of 3 days
16117561|NCT02031328|Radiation|Stereotactic Ablative Radiation|
16117562|NCT02031302|Device|Lotus Valve System|The Lotus Valve System is indicated to improve aortic valve function for symptomatic subjects with severe calcific aortic stenosis (aortic valve area [AVA] of <1.0 cm2 or index of <0.6 cm2/m2) who are at high risk for standard surgical valve replacement.
16117563|NCT02031289|Drug|Erythropoietin/Ferric carboxymaltose/Vitamin B12/Folic Acid|"Treatment ) will be given the day before the operation (day -1) or a maximum of 2 days prior to the operation (day -2) in iron deficiency patients and a maximum of 3 days prior to the operation in anemic patients (day -3).
~Erythropoietin alpha (Eprex, Janssen-Cilag AG, Baar) 40'000 U sc. Ferric carboxymaltose (Ferinject, Vifor (International) AG, St. Gallen) 1000 mg in 100 ml NaCl over 30 min.
~Vitamin B12 (Vitarubin®-superconc., Streuli Pharma AG, Uznach) 1 mg sc. Folic acid (Acidum folicum, Streuli Pharma AG, Uznach) 5 mg po."
16117564|NCT02031276|Drug|risankizumab IV|risankizumab administered by IV infusion
16117565|NCT02031276|Drug|risankizumab SC|risankizumab administered by SC injection
16117566|NCT02031276|Drug|Placebo|Placebo for risankizumab administered by IV infusion
16117567|NCT02031263|Procedure|bronchial thermoplasty system|Check on the quality of life, emergency room uses, and sudden progress of the disease of the patients before and after the treatment by using bronchial thermoplasty system by using paired t test.
16117568|NCT02031250|Drug|Cisplatin|Cisplatin 40mg/m2 administered as an IV infusion prior to radiotherapy on day 1 of each week of chemo-irradiation
16117569|NCT02031250|Drug|Carboplatin|Patients considered medically unfit to receive Cisplatin as determined by the prescribing physician, will receive Carboplatin via IV infusion on day 1 of each week of chemo-irradiation
16117570|NCT02031250|Radiation|IMRT (Intensity-Modulated Radiation Therapy)|
16117571|NCT02031250|Radiation|Boost Radiation to Hypoperfused Volumes|
16117572|NCT02031237|Radiation|Single Fraction Stereotactic Radiosurgery (SRS)|Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment.
16117573|NCT02031237|Radiation|Fractionated Whole Brain Radiation Therapy (WBRT)|Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment.
16117574|NCT02031237|Radiation|Fractionated Stereotactic Radiation Therapy (FSRT)|Intervention will not be assigned by the investigator. Treatment determination will be made prior to study enrollment.
16117575|NCT02031237|Device|Magnetic Resonance Imaging (MRI) Assessments|MRI scans will include a routine clinical MRI series.
16117576|NCT02031224|Behavioral|Conventional low protein diet|
16117577|NCT02031224|Dietary Supplement|Very low protein diet supplemented with Ketosteril|
16117578|NCT02031211|Drug|Etanercept|The patient will receive 0.4 ml/kg as the 25mg/ml preparation subcutaneously.
16117579|NCT02031211|Drug|Placebo|The patient will receive 0.4 ml/kg of Normal Saline injected subcutaneously.
16117580|NCT02031198|Drug|AADvac1|Active immunization against pathological Alzheimer's disease tau protein
16117581|NCT02031185|Behavioral|FitBit only|Participants will use the FitBit device
16117582|NCT02031185|Behavioral|FitBit and Text Messages|Participants will use the FitBit device and receive daily affective text messages
16117583|NCT02031146|Procedure|Lumbar puncture|
16117584|NCT02031107|Device|cTBS|
16117585|NCT02031107|Device|cathodal tDCS|
16117586|NCT02031107|Device|sham stimulation|
16117587|NCT02031094|Other|Observational study: Sense Wear armband and indirect calorimetry used to measure resting energy expenditure|Observational methods of measuring resting energy expenditure
16117588|NCT02031081|Drug|Prucalopride|2 X 2 mg tablets (encapsulated) by mouth once daily for 28 days
16117589|NCT02031081|Drug|Placebo|2 X 100mg tablets (encapsulated) by mouth once daily for 28 days
16117590|NCT02031068|Behavioral|Active Rehabilitation Program|"The active rehabilitation program will be implemented for a maximum of 6-8 weeks. Each participant will be followed by regular weekly telephone calls or personal follow-up relating to outcome from concussion and managing symptoms. The participant will receive TAU (above) in addition to the 4 components listed below:
~Sub-maximal aerobic training for up to 15 minutes
~Light coordination and sport-specific exercises for up to 10 minutes
~Visualization and imagery techniques
~Home program
~A physiotherapist will supervise the rehabilitation."
16117822|NCT02029456|Drug|25 mg Actilyse ( Boehringer Ingelheim, Germany) infusion in 6 hours|
16117591|NCT02031068|Behavioral|Treatment-as-usual (TAU)|"The TAU program will be implemented after the initial assessment. It will consist of 2 components:
~An initial education session by an occupational therapist, relating to outcome from concussion and managing symptoms A school consultation to provide teacher education, recommend accommodations, and facilitate return to school"
16117592|NCT02031055|Drug|TAS-102 with a light tracer dose of [14C]FTD|A single dose of 60 mg TAS-102 with a light tracer dose (200 nCi, approximately 1.2 μg) of [14C]FTD administered as an oral solution on Day 1 (mass balance part)
16117593|NCT02031055|Drug|TAS-102 with a light tracer dose of [14C] TPI|A single dose of 60 mg TAS-102 with a light tracer dose (1000 nCi, approximately 5.6 μg) of [14C]TPI administered as an oral solution on Day 1 (mass balance part)
16117594|NCT02031055|Drug|TAS-102 tablets|35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met. Treatment starts during study extension part (day 9 of the study).
16117595|NCT02031016|Drug|Fentanyl|"fentanyl bolus injections on an as needed base, NEXT TO the fentanyl bolus injections on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium."
16117596|NCT02031016|Drug|Remifentanil|starting with 0.15 ug/IBW(kg)/min, next to fentanyl bolus injections (200-500 ug) on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium.
16117597|NCT02031016|Drug|Fentanyl|fentanyl bolus injections on predetermined times; before incision, at sternotomy, at aorta canulation and at opening of the pericardium.
16117598|NCT02031003|Dietary Supplement|Infant formula|Infant formula
16117599|NCT02030990|Drug|Mitomycin-C|0.01% applied to cornea with a sponge during PRK
16117600|NCT02030990|Drug|Fluorometholone 1% topical ocular steroid|topical steroid drops applied to the cornea after PRK
16117601|NCT02030977|Dietary Supplement|Resveratrol|
16117602|NCT02030977|Other|placebo|
16117603|NCT02030964|Drug|DFMO|
16117604|NCT02030964|Drug|Celecoxib|
16117605|NCT02030964|Drug|Cyclophosphamide|
16117606|NCT02030964|Drug|Topotecan|
16117607|NCT02030938|Device|SERI® Surgical Scaffold|Standard revision augmentation (with or without implant exchange) with the adjunctive use of SERI® Surgical Scaffold placed intra- or extra-capsularly.
16117608|NCT02030925|Drug|IW-3718|
16117609|NCT02030925|Drug|Matching Placebo|
16117610|NCT02030912|Drug|3 doses of amoxicillin daily for 7 days|
16117611|NCT02030912|Drug|2 doses of minocycline daily for five days|
16117612|NCT02030912|Other|2 doses of placebo daily for five days|
16117613|NCT02030899|Procedure|Cage fusion|Randomized selection of surgery type
16117614|NCT02030899|Procedure|Plate fusion|Randomized selection of surgery type
16117615|NCT02030886|Device|Sensimed Triggersfish® (TF)|All subjects will be monitored by Sensimed Triggerfish (TF) for 24 hours.
16117616|NCT02030873|Other|Virtual simulation training|Virtual simulation training in the Visible Ear Simulator.
16117617|NCT02030860|Drug|Paricalcitol|Dose: 25 micrograms Route: IV Frequency (within a 28 day cycle):Three times weekly for one cycle beginning day 1 of therapy until the day before surgery (+/- 3 days) (for subjects randomized to receive paricalcitol), then three times weekly for 3 cycles post-operatively (for all subjects).
16117618|NCT02030860|Drug|Abraxane|Dose: 125mg/m2 Route: IV infusion over 30 minutes Frequency (within a 28 day cycle): Day 1, 8, 15
16117619|NCT02030860|Drug|Gemcitabine|Dose: 1000mg/m2 Route: IV infusion over 30-100 minutes Frequency (within a 28 day cycle): Day 1, 8, 15
16117620|NCT02030847|Biological|CART-19|CART-19 cells transduced with a lentiviral vector to express anti-CD19 scFv TCR:41BB administered by a single i.v. infusion of 1 to 5 x 10^8 transduced CAR T cells
16117621|NCT02030847|Biological|CART-19|As of June 2014, dose was reduced to a single dose of 1-5x10^7 CART-19 cells.
16117622|NCT02030847|Biological|CART-19|In the protocol amendment in November 2014, the dose remained 1-5 x 10^7 CART-19 cells, but was revised to be administered via split dosing: 10% on Day 1, 30% on Day 2, 60% on Day 3.
16117623|NCT02030847|Biological|CART-19|In the protocol amendment in May 2015, the dose was changed to 1-5 x 10^8 CART-19 cells administered via split dosing: 10% on Day 1 (1-5x10^7), 30% on Day 2 (3x10^7-1.5x10^8), 60% on Day 3 (6x10^7-3x10^8).
16117624|NCT02030834|Biological|CART-19|Single infusion of CART-19 cells administered by i.v. injection (total dose of 1 - 5 x108 CART-19 cells, calculated as a range of 2-50% transduced cells in total cells).
16117625|NCT02030821|Drug|Amicar|Subjects randomized to receive Amicar will receive this during surgical intervention
16117626|NCT02030821|Drug|TXA|Subjects randomized to receive TXA will receive this during surgical intervention
16117627|NCT02030808|Drug|Muscle Relaxants (MR) group|patients received 0.2 mL/kg cisatracurium® (Nimbex) 0.2%, and a left-sided endobronchial double-lumen tube was placed when the TOF revealed one or two twitches
16117628|NCT02030808|Drug|Non- Muscle Relaxants (NMR) group|No cisatracurium® (Nimbex) will be administered
16117629|NCT02030795|Other|Disconnection group|The blocker cuff was deflated, the single lumen tube was disconnected from the ventilator for 60 s allowing the surgical lung to collapse, then the cuff was re-inflated with the same amount of air as determined previously and the ventilator was reconnected to the single lumen tube
16117630|NCT02030795|Other|Bronchial Suction group|The barrel part of a 1-mL insulin syringe was attached to the suction port of the bronchial blocker, and connected to -30 cm H2O of suction.
16117631|NCT02030782|Other|Quality Improvement (QI) for depression|Major intervention components included a) expert leader teams who planned and implemented the intervention at each clinic, b) care managers who supported primary care clinicians with depression evaluation and management, c) access to cognitive-behavior therapy for depression within each primary care clinic, and d) patient and provider choice regarding treatment modality.
16117632|NCT02030782|Other|Usual Care|Usual care enhanced by provider education regarding depression evaluation and management
16117633|NCT02030769|Drug|Pronase|use pronase to improve visibility during endoscopical iodine staining
16117634|NCT02030769|Drug|Control|No pronase plus Dimethicone and sodium bicarbonate. use without pronase to compare visibility during endoscopical iodiine staining
16117635|NCT02030756|Device|vibrating capsule|patients will receive vibrating capsule for 8 weeks of treatment [1 every 3 days (+/- 1 day)].
16117636|NCT02030756|Device|sham non-vibrating capsule|patients will receive sham non-vibrating capsule for 8 weeks of treatment [1 every 3 days (+/- 1 day)].
16117637|NCT02030743|Other|Visual training|6 training sessions with computerised visual attention paradigm
16117638|NCT02030730|Behavioral|Triple P Seminar Series|The intervention was delivered by the researcher and an accredited TripleP practitioner. The seminars took place in a conference room located within a bookshop. The seminars were re-offered for parents who could not attend the scheduled day.
16117639|NCT02030717|Drug|klonidin|spinal injection of 12 mg bupivacain,160 ug morfin och klonidin, according to age
16117640|NCT02030717|Drug|epidural anesthesia|epidural anesthesia: patients get an continuous infusion of a solution with bupivacain 1 mg/ml, fentanyl 1 ug/ml and adrenalin 1 ug/ml
16117641|NCT02030691|Device|Nasal continuous airway positive pressure (nCPAP)|
16117642|NCT02030691|Device|Nasal high frequency percussive ventilation (nHFPV)|
16117643|NCT02030678|Drug|irinotecan|Irinotecan monotherapy (trade name: Aili; batches 180103AG [40 mg] and 171231AG [100 mg]) will be administered intravenously at a dose of 100 mg/m2 on days 1 and 8 of each 3-week cycle.
16117644|NCT02030665|Behavioral|Contingency Management|Reinforcement provided contingent upon demonstration of negative drug tests
16117645|NCT02030665|Behavioral|Individualized Assessment & Treatment|Tailored Cognitive-Behavioral Treatment based on detailed records of patient behavior
16117646|NCT02030665|Behavioral|Cognitive-Behavioral Treatment|Standard psychoeducational approach to coping skills training
16117647|NCT02030652|Procedure|Intermittent nasal positive pressure positive ventilation.|
16117648|NCT02030652|Procedure|CPAP|Nasal continuous positive airway pressure
16117649|NCT02030639|Drug|rigosertib|A single dose of 450 mg of rigosertib containing 250 microcuries of carbon 14-labeled rigosertib ([14C]-rigosertib) administered as a continuous intravenous (CIV) infusion over 24 hours to healthy volunteers.
16117650|NCT02030626|Device|active or placebo rTMS or active or placebo tDCS|
16117651|NCT02030613|Genetic|Blood test|
16117652|NCT02030600|Drug|insulin degludec|Administered once daily injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.
16117653|NCT02030600|Drug|insulin glargine|Administered once daily injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.
16117654|NCT02030587|Procedure|Radiofrequency Ablation|
16117655|NCT02030587|Procedure|Laparoscopic Adrenalectomy|
16117656|NCT02030574|Drug|Gemcitabine and fractionated cisplatin (combination treatment)|1 Cycle = 21 days. GC x 4 cycles ----> cystectomy Gemcitabine: 1000mg/m2, days 1 and 8 Cisplatin: 35mg/m2, days 1 and 8
16117657|NCT02030561|Drug|Trastuzumab + NK cells|
16117658|NCT02030535|Drug|olodaterol|free combination with tiotropium
16117659|NCT02030535|Drug|tiotropium|free combination with olodaterol
16117660|NCT02030535|Drug|Placebo|
16117661|NCT02030535|Drug|tiotropium|fixed dose combination with olodaterol
16117662|NCT02030535|Drug|olodaterol|fixed dose combination with tiotropium
16117663|NCT02030522|Behavioral|Accelerated Resolution Therapy (ART)|"The ART protocol will be delivered in 2-5 sessions. Imaginal Exposure (IE) will be used whereby service members and veterans will be asked to recall (verbally or non-verbally) details of the traumatic event(s) while focusing their attention on physiological sensations, thoughts, and emotions. This short period of exposure to the memory will be followed by identification and diminishment of the emergence of any uncomfortable emotional or somatic symptoms. Imagery Rescripting (IR) will be used to change (replace) negative traumatic images to positive images. The service member/veteran will imagine and play out an affectively-driven solution to change sensory components of the memory, as if they were the director of the movie of the memory they are working on."
16117664|NCT02030509|Other|Quick diagnosis program|
16117665|NCT02030496|Procedure|open reduction and internal fixation|The surgery will be performed by a certified trauma surgeon. After the fracture site is exposed, the fracture will be reduced and provisionally fixed with K-Wires and reduction forceps. An appropriate volar locking plate which best suits the anatomy of the wrist and the fracture type will be selected. Screw placement and fracture reduction will be confirmed intra-operatively by radiographic images. No post-operative fixation will be applied and patients will be instructed to use the affected extremity in daily activities as pain allows. According to Dutch treatment standards, vitamin C 500 milligrams will be prescribed to all patients at initial presentation and for a duration of two months in order to prevent Complex Regional Pain Syndrome.
16117666|NCT02030496|Other|Closed reduction and plaster|Closed reduction will be performed according to the Robert-Jones method. This involves increasing the deformity first, then applying continuous traction and immobilising wrist and hand in the reduced position. Additional radiographs will be performed to verify the quality of the reduction. After this has been confirmed, the wrist will be immobilised according to Dutch guidelines: a splint for one week followed by a circular cast for another four weeks. According to Dutch treatment standards, vitamin C 500 milligrams will be prescribed to all patients at initial presentation and for a duration of two months in order to prevent Complex Regional Pain Syndrome.
16117667|NCT02030483|Drug|Palbociclib|Palbociclb will be given at predefined dose level of 75 mg, 100 mg, 125 mg, or 150 mg days 1-14 every 28 days (days 0-14 for cycle 1 only).
16117668|NCT02030483|Drug|Dexamethasone|20 mg by mouth on days 1, 8, 15 and 22 of a 28-day cycle (Day 1 dosing is omitted for cycle 1 only).
16117669|NCT02030483|Drug|Lenalidomide|Lenalidomide at predefined dose level of 5mg, 10 mg, 15 mg, 25 mg daily for days 8-21 (or days 1-21, depending on dose level cohort).
16117670|NCT02030470|Other|Fotosan®630. LED lamp. Toluidinblue. Photoactivated disinfection|
16117671|NCT02030457|Drug|Beclomethasone dipropionate BAI|Breath Activated Inhaler (BAI)
16117672|NCT02030457|Drug|Beclomethasone dipropionate MDI|Metered Dose Inhaler (MDI)
16117673|NCT02030444|Procedure|PET-MRI and EBUS-TBNA|
16117674|NCT02030431|Device|Dynaloc|
16117675|NCT02030431|Device|Cancellous screws|
16117676|NCT02030418|Device|Leadless Pacemaker|Patients will undergo an attempted leadless pacemaker implant
16117677|NCT02030405|Drug|Ixazomib|Given orally (PO)
16117678|NCT02030392|Behavioral|Intervention group|Cognitive-behavioral intervention
16117679|NCT02030392|Behavioral|Active control group|Education and information
16117680|NCT02030379|Behavioral|QPL-CT|Use the QPL-CT to prioritize questions
16117681|NCT02030353|Behavioral|Self-regulation plus activity monitoring|Individual in-person session, digital smart scale, online intervention, and an activity monitor.
16117682|NCT02030353|Behavioral|Self-regulation|Individual in-person session, digital smart scale, and online intervention.
16117683|NCT02030340|Procedure|lower urinary tract dysfunction|Urodynamic investigation with a double (two systems: air-charged and water filled) catheter system
16117684|NCT02030314|Drug|Chlorthalidone|treatment of resistant hypertension in kidney transplant patients
16117685|NCT02030301|Biological|VCL-HB01|Plasmid DNA vaccine encoding two HSV-2 proteins; formulated with Vaxfectin®
16117686|NCT02030301|Biological|VCL-HM01|Plasmid DNA vaccine encoding one HSV-2 protein; formulated with Vaxfectin®
16117687|NCT02030301|Biological|PBS|Phosphate-buffered saline
16117688|NCT02030288|Behavioral|Relational Agent Intervention|"Relational Agents are on-screen characters that speak to the patient and establish a relationship with them. They have been used to improve several health behaviors including diet and exercise, and can overcome communication barriers related to low levels of computer literacy. The Relational Agent can be placed on a desktop or tablet computer with a touch screen, on which patients indicate their responses. Using Motivational Interviewing and behavior change principles, the Relational Agent guides patients to consider change."
16117689|NCT02030275|Drug|RXI-109|surgery.
16117690|NCT02030275|Drug|Placebo|surgery.
16117691|NCT02030262|Procedure|Epiretinal membrane peeling with fluid-air exchange|The intervention starts with a pars plana vitrectomy and then a epiretinal membrane peeling is performed. During the fluid-gaz exchange, the gaz used will be air. The remaining of the intervention is the same between the two arms.
16117692|NCT02030262|Procedure|Epiretinal membrane peeling with fluid-SF6 exchange|The intervention starts with a pars plana vitrectomy and then a epiretinal membrane peeling is performed. During the fluid-gaz exchange, the gaz used will be SF6 (sulfur hexafluoride). The remaining of the intervention is the same between the two arms.
16117693|NCT02030249|Behavioral|Low calorie diet administered from 0 to 2 months|The 2-month low calorie diet is administered from the 0 months to the 2 months time point. It is designed to elicit a weight loss of 8% of initial body weight. Please see parent study for further intervention details: http://clinicaltrials.gov/ct2/show/NCT01777893?term=preview&rank=1
16117694|NCT02030249|Behavioral|High Protein / Low Glycaemic Index|Please see description of the Arm by the same name.
16117695|NCT02030249|Behavioral|Moderate Protein / High Glycaemic Index|Please see description of the Arm by the same name.
16117696|NCT02030236|Device|Cooling|Temperature reached Duration of exposure to cold.
16117697|NCT02030223|Procedure|Transversus abdominis plane block|ultrasound guided transversus abdominis plane block
16117698|NCT02030197|Behavioral|CRISP Program|Educational program to improve self-efficacy, loneliness and depression
16117699|NCT02030197|Other|Control Group|no treatment
16117700|NCT02030184|Drug|Rhenium Re 188-P2045|Topotecan at 1.0 mg/m2 or 1.5 mg/m2 for 3 days, followed by single dose of Rhenium Re 188-P2045, at one of the following dosage levels based on the Phase I Maximum Tolerated Dose (MTD): 40% of MTD; 50% of MTD; 75% of MTD; 85% of MTD or 100% of MTD.
16117701|NCT02030171|Other|functionnal reeducation|Specific functionnal reeducation for chronic low back pain
16117702|NCT02030145|Procedure|Compressive Thoracic Lymphatic Pump|This technique is a modification of the Classic Thoracic Lymphatic Pump where some pressure is maintained on the chest wall at the end of each exhalation and at the end of the third or fourth breathing cycle, during the inhalation phase, the hands are slowly removed from the chest wall, gradually releasing pressure on the chest without causing a sudden change in intrathoracic pressures.
16117703|NCT02030145|Procedure|Classic Thoracic Lymphatic Pump|This technique is well described in Chapter 68 of the Foundations for Osteopathic Medicine, 2nd Edition.
16117704|NCT02030132|Behavioral|Feedback compared to 75th percentile|
16117705|NCT02030132|Behavioral|Forgiveness|
16117706|NCT02030132|Behavioral|Financial Incentive|For the first three months of the study, a weekly lottery will be held. Teams whose average daily step count for that week is ≥ 7000 will be eligible to collect their lottery winnings. Teams whose average daily step count is less than 7000 will receive messages about how much they would have won had the team met its goal.
16117707|NCT02030132|Behavioral|Daily Feedback|Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before.
16117708|NCT02030119|Behavioral|Financial Incentives|
16117709|NCT02030119|Behavioral|Daily feedback|
16117710|NCT02030093|Behavioral|Telephone-based counseling|Telephone-based continuing care wil be provided to patients in different frequency
16117711|NCT02030080|Behavioral|Financial incentives|
16117712|NCT02030080|Behavioral|Teams|
16117713|NCT02030080|Behavioral|Framing of feedback|
16117714|NCT02030080|Behavioral|Daily Feedback|Participants will be given daily feedback on whether or not they walked 7000 steps or more the day before.
16117715|NCT02030067|Drug|RX-3117|escalating doses (Phase 1)
16117716|NCT02030054|Drug|Atorvastatin|Patients were randomly assigned to atorvastatin (40 mg day) for 30 days. After 1-week wash-out period to avoid any carryover effect, cross-over was performed, and patients were switched to the other drug which was continued for 30 days.
16117717|NCT02030054|Drug|Rosuvastatin|Patients were randomly assigned to rosuvastatin (20 mg day) for 30 days. After 1-week wash-out period to avoid any carryover effect, cross-over was performed, and patients were switched to the other drug which was continued for 30 days.
16117718|NCT02030041|Drug|Vitamin D|Vitamin D will be given to achieve normal serum levels
16117719|NCT02030041|Drug|Simvastatin|Simvastatin in a dose of 40 mg will be provided to the study participants
16117720|NCT02030041|Drug|Placebo|Placebo will be provided to the study participants
16117721|NCT02030028|Drug|ACTHAR gel|Subjects are given the ACTHAR gel subcutaneously twice per week for 12 weeks.
16117722|NCT02030015|Drug|miglustat|The Syner-G therapy regimen includes treating with orally-administered miglustat for the duration of the 60-month study.
16117723|NCT02030015|Other|Ketogenic Diet|The Syner-G therapy regimen includes switching the research subject to a full-time ketogenic diet for the 60-month duration of this study.
16117724|NCT02030002|Device|APC Flash-Free Adhesive Coated Appliance System|APC Flash-Free Adhesive Coated Appliance System
16117824|NCT02029430|Drug|aldoxorubicin|
16117727|NCT02029989|Device|Glycosylated Hemoglobin A1c|"Point-of-care (POCT) screening for diabetes
~Glycosylated Hemoglobin A1c"
16117728|NCT02029989|Device|Blood Pressure and Heart Rate|"Point-of-care (POCT) screening for hypertension
~Blood Pressure and Heart Rate"
16117729|NCT02029989|Device|Body mass index|Height and weight measurement used to calculate BMI = Mass(kg)/(height (m))squared
16117730|NCT02029989|Device|Waist and Hip circumference|"Measurement for Central Obesity
~Waist and Hip circumference"
16117731|NCT02029989|Behavioral|Comprehensive Medication Management|Defined at http://www.pcpcc.org/guide/patient-health-through-medication-management
16117732|NCT02029976|Behavioral|SNAPSHOT (Student, Nurses and Parents Seeking Healthy Options Together)|attention control condition after school weight management program
16117733|NCT02029976|Behavioral|Mailed monthly newsletters|Newsletters
16117734|NCT02029963|Device|Transcranial Magnetic Stimulation (rTMS)|A non-invasive method for brain stimulation
16117735|NCT02029963|Behavioral|Treatment as Usual|An individually-tailored maintenance plan as determined by a psychiatrist or primary care provider
16117736|NCT02029950|Drug|Cytarabine|Given IV
16117737|NCT02029950|Drug|Daunorubicin Hydrochloride|Given IV
16117738|NCT02029950|Drug|Etoposide|Given IV
16117739|NCT02029950|Drug|Idarubicin Hydrochloride|Given IV
16117740|NCT02029950|Other|Laboratory Biomarker Analysis|Correlative studies
16117741|NCT02029950|Other|Pharmacological Study|Correlative studies
16117742|NCT02029950|Drug|Pomalidomide|Given PO
16117743|NCT02029937|Drug|Proflavine, high resolution imaging|5-10 ml of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa. The HRME will then be inserted through the endoscope and gently placed against the mucosa. Imaging of abnormal tissues will be performed.
16117744|NCT02029924|Drug|BioChaperone insulin lispro|Single dose of 0.2 U/Kg body weight injected subcutaneously (under the skin)
16117745|NCT02029924|Drug|Humalog®|Single dose of 0.2 /Kg body weight injected subcutaneously (under the skin)
16117746|NCT02029911|Device|Aurora Endometrial Ablation System|Ablation of the endometrial lining of the uterus using the Aurora System
16117747|NCT02029898|Drug|Remifentanil|
16117748|NCT02029898|Drug|sodium chloride 0,9%|
16117749|NCT02029885|Device|Investigational Therapy (Surround Sound)|
16117750|NCT02029885|Device|Sham Control|
16117751|NCT02029872|Drug|Chlorhexidine gluconate soap|4% chlorhexidine gluconate (soap)
16117752|NCT02029872|Drug|Chlorhexidine gluconate oral rinse|chlorhexidine gluconate oral rinse 0.12%
16117753|NCT02029872|Drug|Mupirocin calcium 2 % ointment|nasal mupirocin calcium 2% ointment
16117754|NCT02029859|Procedure|Polygraphic examination|Polygraphic examination between 30 and 36 weeks of amenorhea
16117755|NCT02029846|Drug|Standard Treatment|traditional drugs only
16117756|NCT02029846|Drug|Incretin-Based Treatment|incretin-based drugs
16117757|NCT02029833|Other|Regular Canola Oil|
16117758|NCT02029833|Other|High Oleic Canola Oil|
16117759|NCT02029833|Other|Western Type Diet - Common Dietary Oils|
16117760|NCT02029820|Device|RenalGuard|Intravenous saline hydration matched with urine output, using the device Renalguard
16117761|NCT02029794|Procedure|HPV self-colleciton|Women will self-collect a cervical sample that will be provided to an outreach worker and then labelled and sent to laboratories in Kampala for HPV testing. Women who test positive for HPV will be contacted by phone and provided with follow-up instructions.
16117762|NCT02029794|Procedure|visual inspection with acetic acid (VIA)|
16117763|NCT02029794|Drug|3-5% acetic acid|
16117764|NCT02029781|Procedure|LAPP score|Use of the LAPP score during a diagnostic laparoscopy.
16117765|NCT02029755|Procedure|transversus abdominis plane block|bilateral ultrasound-guided transversus abdominis plane block, with 20 ml of 0.25% ropivacaine at each side after the induction of general anesthesia
16117766|NCT02029755|Procedure|local infiltration|local anesthetics infiltration at surgical wound with 20 ml of 0.5% ropivacaine before wound closure
16117767|NCT02029755|Procedure|Patient controlled analgesia|postoperative analgesia with intravenous patient controlled analgesia with morphine
16117768|NCT02029742|Behavioral|Community Health Worker (CHW)|CHWs will have scheduled interactions with subjects at home, by telephone or at Community League of the Heights (CLOTH), our partner community-based organization (CBO). CHWs will customize text messaging jointly with each youth and parent (Month 3) and text message reminders to both parent and youth will be implemented during Months 4-6. Subjects lacking a mobile phone or sufficient cell phone plan will be compensated to purchase or upgrade plans to accommodate texts.
16117769|NCT02029742|Behavioral|Education|Dyads randomized to the control group will continue usual clinic-based care, including monitoring and review of HbF levels, and similar frequency of clinic visits and access to sickle cell team staff. They will be provided with educational materials about sickle cell disease and hydroxyurea use for children.
16117770|NCT02029729|Drug|omaveloxolone|
16117771|NCT02029716|Drug|RTA 408 Lotion 0.5%, 1%, 3%|
16117772|NCT02029716|Drug|Lotion vehicle/placebo|
16117773|NCT02029703|Device|Synvisc-One Injection|
16117774|NCT02029703|Other|Sham Injection|
16117775|NCT02029690|Drug|ADI-PEG 20|
16117776|NCT02029664|Device|Visual distortion increment based on the gait pattern|
16117777|NCT02029651|Device|E-glove system|Novel rehabilitation system using game for upper extremity rehabilitation for patients with stroke
16117778|NCT02029651|Procedure|Conventional occupational therapy|conventional occupational therapy
16117779|NCT02029638|Biological|anti-thymocyte globulin|An initial dose of 0.5 mg/kg IV will be administered over 6 hours on Day -9. Thereafter the daily dose will be increased to 2 mg/kg IV given over 4 hours on Days -8 and -7. No more than 150 mg of ATG may be administered per day.
16117780|NCT02029638|Drug|Fludarabine|Fludarabine at dose 30 mg/m^2 will be administered daily by intravenous infusion over 30 minutes on Day -6 to Day -2.
16117825|NCT02029417|Drug|cytarabine|Given SC
16117826|NCT02029417|Drug|omacetaxine mepesuccinate|Given SC
16117827|NCT02029417|Drug|decitabine|Given IV
16117828|NCT02029417|Other|laboratory biomarker analysis|Correlative studies
16118264|NCT02025907|Drug|Placebo|One placebo capsule taken orally (by mouth) once daily.
16117781|NCT02029638|Drug|Cyclophosphamide|"Low dose pre-transplant cyclophosphamide will be administered intravenously (IV) over 1- 2 hours, (depending on volume) on Days -6 and -5. The dose of pre-transplant cyclophosphamide is 14.5 mg/kg/day.
~High dose cyclophosphamide [50mg/kg (Ideal Body Weight)] will be administered on Day 3 post-transplant (within 60 to 72 hours of marrow infusion) and on Day 4 post-transplant. Cyclophosphamide will be given IV over 1-2 hours depending on volume."
16117782|NCT02029638|Radiation|Total Body Irradiation|Total body irradiation, consisting of 200 centigray (cGy) Anterior-Posterior/Posterior-Anterior (AP/PA) with 4 Megavolts (MV) or 6 MV photons at 8-12 cGy/min at the point of prescription will be administered in a single day on Day -1.
16117783|NCT02029638|Drug|acetaminophen|650 mg orally prior to antithymocyte globulin infusion.
16117784|NCT02029638|Drug|diphenhydramine|25mg diphenhydramine orally prior to antithymocyte globulin infusion.
16117785|NCT02029638|Drug|methylprednisolone|On Days -9 to -7 methylprednisolone 1mg/kg IV 1 hour prior ATG. This dose may be repeated once 3 hours after the first dose of steroids. On Day -6 and -5, methylprednisolone 0.75 mg/kg/ IV as a single dose; on Days -4 and -3, methylprednisolone 0.5 mg/kg/ IV as a single dose; on Day -2 methylprednisolone 0.25 mg/kg/ IV as a single dose.
16117786|NCT02029638|Biological|bone marrow transplant|Unprocessed, unmanipulated bone marrow will be harvested from the donor and infused into the recipient on Day 0.
16117787|NCT02029638|Drug|MESNA|A series of MESNA doses will be administered for each dose of high dose, post-transplant cyclophosphamide. The total daily dose of MESNA is equal to 80% of the total daily dose of cyclophosphamide.
16117788|NCT02029638|Drug|mycophenolate mofetil|MMF will be administered at a dose of 15 mg/kg orally three times per day based upon actual body weight, with the maximum of 3 grams a day from Day 5 to 35. The dose will then be reduced to the standard 1 g twice daily thereafter.
16117789|NCT02029638|Drug|prednisone|Prednisone will be administered at a dose of 10 mg orally daily from Day 5 for 12 weeks. Thereafter the dose will be reduced to 5 mg orally daily.
16117790|NCT02029638|Drug|filgrastim|All recipients will receive 5 microgram/kg per day of filgrastim as a single, subcutaneous injection from Day 5 post-transplant until the absolute neutrophil count is greater than 1000/µl on three consecutive measurements over at least 2 days.
16117791|NCT02029625|Drug|NVP-1205|rosuvastatin/ezetimibe fixed dose combination orally, once daily on Period 1 or Period 2
16117792|NCT02029625|Drug|rosuvastatin and ezetimibe|coadministration of rosuvastatin and ezetimibe orally, once daily on Period 1 or Period 2
16117793|NCT02029612|Drug|Nicotine Patch|10 week supply of nicotine patches given to participants at baseline.
16117794|NCT02029612|Behavioral|Phone Counseling|Each participant counseled on quitting smoking at baseline.
16117795|NCT02029612|Behavioral|Questionnaires|Questionnaires completed at baseline, 3 months, and at 6 months.
16117796|NCT02029612|Behavioral|Breath Test|Breath test performed at 3 month and 6 month visit.
16117797|NCT02029612|Behavioral|Proactive Cell Phone Smoking Cessation Counseling|Participant receives 11 phone calls from study staff over a 6-month period.
16117798|NCT02029612|Behavioral|Text Message Smoking Cessation Support|Participants receive text messages for support about quitting smoking over a 6 month period.
16117799|NCT02029599|Drug|Fang yi qing feng shi granule|10g, Oral,Three each time, 3 times a day,for 3 months;
16117800|NCT02029599|Drug|placebo|10g, Oral,Three each time, 3 times a day,for 3 months
16117801|NCT02029599|Drug|Methotrexate|7.5-15mg per week，All patients should be used
16117802|NCT02029599|Drug|Acetaminophen tablets|Oral,0.5g, 1~2 times a day, when vas=10
16117803|NCT02029586|Drug|MB12066 200mg|oral administration, 100mg bid
16117804|NCT02029586|Drug|Placebo|oral administration, 100mg bid
16117805|NCT02029573|Drug|Atorvastatin|80 mg po daily until disease progression or unacceptable toxicity. (starting dose of 40 mg po daily for the first 21 days)
16117806|NCT02029573|Drug|Temozolomide|75mg/m2 po daily during radiotherapy, followed by 150-200mg/m2/day po on days 1-5 of each 6x4 week cycle of adjuvant therapy
16117807|NCT02029573|Radiation|Radiotherapy|60 Gy in 30 fractions
16117808|NCT02029547|Drug|Florbetapir (18F)|No Florbetapir (18F) will be administered in this study.
16117809|NCT02029534|Drug|Atorvastatin 20 mg|
16117810|NCT02029534|Drug|Atorvastatin 80 mg|
16117811|NCT02029521|Dietary Supplement|Oral reduced l-glutathione|The treatment was pharmaceutical-grade Reduced L-Glutathione (GSH) with a daily dose of 65 mg/kg. The placebo was calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
16117812|NCT02029521|Dietary Supplement|Placebo|calcium citrate with a daily dose of 65 mg/kg. The daily dose of each substance was divided into three doses given at mealtime.
16117813|NCT02029508|Procedure|Modified Epley maneuver|For Modified Epley maneuver, the patient was placed in the upright position with the head turned 45 degrees toward the affected ear. And then the patient was rapidly laid back to the supine head-hanging position for 1 minute. Next, the head was turned 90 degrees toward the other (unaffected) side for 1 minute. Next, the head is turned a further 90 degrees (usually necessitating the patient's body to also move from the supine position to the lateral decubitus position) such that the patient' head is nearly in the facedown position for 1 minute. The patient is then brought into the upright sitting position for 1 minute, completing the maneuver.
16117814|NCT02029508|Procedure|Semont maneuver|Patient's head was turned 45 degrees toward the healthy side. And then patient was rapidly moved to affected side-lying position and sustained for 2 minutes. Next, Patient is rapidly taken to the opposite side-lying position without pausing in the sitting position or changing the head position relative to the shoulder for 2 minutes. Next, Patient returns slowly with the head still tilted and fixed until the seated position for 1 minute.
16117815|NCT02029508|Procedure|Reverse Epley maneuver|Like the modified Epley maneuver, but the direction was reverse.
16117816|NCT02029495|Drug|210 mg brodalumab|210 mg brodalumab administered via subcutaneous injection
16117817|NCT02029495|Drug|140 mg brodalumab|140 mg brodalumab administered via subcutaneous injection
16117818|NCT02029495|Drug|Placebo|Placebo administered via subcutaneous injection until week 24.
16117819|NCT02029482|Drug|ACT-128800|
16117820|NCT02029482|Drug|Placebo|
16117821|NCT02029469|Device|Ascension HRA device|Patients who are treated with the Ascension® HRA for resurfacing of humeral head.
16118594|NCT02023229|Dietary Supplement|Branched-chain aminoacids|
16117829|NCT02029404|Procedure|Tibial nerve group|"After the recovery of the sensitivity we will start the continuous infusion of levobupivacaine 0,125% with a portable pump (Mini Rythmic Evolution, Micrel Medical Devices) with a flow basal rate 2 ml/h and a rescue bolus doses of 2 ml (lock out 20 minutes). Before the discharge from the hospital, if the NRS will be > 4, a bolus of 10 ml of Mepivacaine 1% through the catheter could be administered.
~An information sheet will be released at the discharge and the medical indication for any rescue doses at home.
~The patients will be contacted by phone at POD 1-2 and will allowed to answer to a questionnaire (see endpoint) At POD 3 the patients will come in our ambulatory where we will remove the catheter and they will return the pump"
16117830|NCT02029404|Procedure|Tibial peroneal nerve group|"After the recovery of the sensitivity we will start the continuous infusion of levobupivacaine 0,125% with a portable pump (Mini Rythmic Evolution ,Micrel Medical Devices )with a flow basal rate 2 ml/h and a rescue bolus doses of 2 ml (lock out 20 minutes). Before the discharge from the hospital, if the NRS will be > 4, a bolus of 10 ml of Mepivacaine 1% through the catheter could be administered.
~An information sheet will be released at the discharge and the medical indication for any rescue doses at home.
~The patients will be contacted by phone at POD 1-2 and will allowed to answer to a questionnaire (see endpoint) At POD 3 the patients will come in our ambulatory where we will remove the catheter and they will return the pump"
16117831|NCT02029391|Other|Manual pressure release|Therapist applied non-painful pressure with slowly increase over the myofascial trigger point until he felts a tissue resistance barrier.
16117832|NCT02029391|Other|Kinesio tape|Kinesio tape was adhered from insertion to origin of the upper trapezius muscle
16117833|NCT02029378|Drug|Eculizumab|
16117834|NCT02029365|Other|Autoquestionnary|autoquestionnary completed during the consultation for infertility
16117835|NCT02029365|Other|semi-structured interview|phone interview
16117836|NCT02029352|Drug|Sinecatechins 10%|
16117837|NCT02029352|Drug|Placebo|Composition, apart from the active substance, is otherwise identical to the investigational medical product.
16117838|NCT02029339|Device|Continuous topical triple-tube irrigation and suction|"The triple-tube device was continuous operated: instilled the topical solution through the washing tube, delivered negative pressure therapy at 100 - 125 mmHg continuously through the inner tube of sleeve tubes through the central negative pressure device in the wall of the ward. The outer tube was used for normalize and balance the distribution of the negative pressure around the inner tube to allow the solution to penetrate through the dressing to cover the wound, and protecting the inner tube from getting stuck with the sucked tissue. All tubes are all commercially available (Medical Silicone Tubing, Forbest Manufacturing Co., Ltd, China)."
16117839|NCT02029339|Device|SOC|Debridement, offloading, standard moist wound care, and conventional NPWT without continuous irrigation are the fundamental SOC for Open Abdomen with complicated abdominal infections.
16117840|NCT02029313|Drug|Montelukast|
16117841|NCT02029313|Drug|Montelukast sodium|
16117842|NCT02029300|Other|Fiberoptic Intubation through the nasal route|
16117843|NCT02029300|Other|Fiberoptic intubation through the oral route|
16117844|NCT02029287|Other|Hospital-Community-Family-Care Management Platform Online|Hospital-Community-Family-Care Management Platform Online: the remote monitoring service platform on line based on community and family for subjects with CHF under the guidance of the regional central hospital
16117845|NCT02029287|Other|Subjects with CHF via conventional clinic visit according to the latest relevant guidelines|Subjects with CHF via conventional clinic visit according to the latest relevant guidelines
16117846|NCT02029274|Drug|BAF312|BAF312 was provided as film-coated tablets in strengths of 0.25, 0,5, 1 and 2 mg for oral administration.
16117847|NCT02029274|Drug|Placebo|Matching placebo to BAF312 as tablets for oral administration.
16117848|NCT02029248|Other|Quality of life questionnaire|
16117849|NCT02029235|Drug|Acetaminophen/Ibuprofen|Postoperatively, subjects will be given acetaminophen 500 mg / ibuprofen 400mg every 4 hours, as needed, for one week or until essentially pain-free
16117850|NCT02029235|Drug|Acetaminophen/Hydrocodone|Postoperatively, subjects will be given acetaminophen 325 mg / hydrocodone 5 mg every 4 hours, as needed, for one week or until essentially pain-free
16117851|NCT02029209|Drug|Anlotinib|Anlotinib QD
16117852|NCT02029209|Drug|Placebo Capsule|Placebo capsule QD
16117853|NCT02029196|Other|E-vapour product|Smokers of conventional cigarettes who switch to use an e-vapour product.
16117854|NCT02029196|Other|Conventional cigarette|Smokers of conventional cigarettes who continue smoking conventional cigarettes.
16117855|NCT02029183|Device|Bi level positive pressure ventilation|Bi level positive pressure ventilation should be given for subject for 6 hours per night ，total 7 times.
16117856|NCT02029183|Device|bi-level positive airway pressure|
16117857|NCT02029170|Procedure|Early weightbearing|Patients allocated to early weightbearing group are allowed to weightbear after stitch out and application of a walking cast
16117858|NCT02029170|Procedure|Non-weightbearing|Patients allocated to non-weightbearing group are kept non-weightbearing till 6 weeks post-operative
16117859|NCT02029157|Drug|ARQ197|
16117860|NCT02029157|Drug|Placebo|
16117861|NCT02029131|Behavioral|Exercise|Educated exercise training for the trunk 3 times per week, each for 20 min. Recommendation of additional fitness courses as offered by the local healthy insurance company.
16117862|NCT02029118|Drug|Herbal plaster ( styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech)|Application containing herbal medicine that mainly include styrax, borneol, frankincense, santalum,trichosanthes kirilowii Maxim, allium macrostemon Bunge, leech and other herbal medicine.
16117863|NCT02029118|Device|acupoint|select acupoint according to traditional Chinese medicine
16117864|NCT02029118|Drug|Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn.|foundation treatment
16117865|NCT02029105|Biological|Mesothelin, hyaluronan, osteopontin, syndecan-1|We compere the serum levels of the tumor markers in patients with pleural diseases according to the groups for the diagnosis and differential diagnosis of the diseases.
16117866|NCT02029079|Dietary Supplement|E+|300 ml E+ per day (525 kcal, 22.5 gram protein) for 35 days.
16117867|NCT02029066|Drug|SR-T100 gel|2g of SR-T100 will topical apply on 100 cm^2 once for 24 hours.
16118336|NCT02025205|Device|Endobronchial Valve|Endoscopic Lung Volume Reduction with Zephyr Endobronchial Valve
16117868|NCT02029053|Device|Vaginal Lubrication Ring for Vaginal Dryness|"Participants will be asked to complete 4 study visits and one final follow-up phone call. Each study visit will include a brief vaginal exam where vaginal fluid levels and pH levels are checked and questionnaires are completed. Daily diaries will be completed at home and returned to the study staff at subsequent visits.
~Participants will self-insert the Intravaginal ring on the 1st study visit. The 2nd study visit will occur 3-4 days later.
~The 3rd study visit will occur approximately 7 days after the 1st visit. Participants will remove the device and self-insert a new intravaginal ring.
~The 4th study visit will occur approximately 14 days after the first visit. Participants will remove the intravaginal ring and undergo a final vaginal exam.
~Participants will be called approximately 7 days after the last visit and will be asked about their current vaginal dryness symptoms and how they felt about the device during the study."
16117869|NCT02029040|Drug|3% Hypertonic Saline|Within 5-15 minutes following the administration of the study drug, the Respiratory Distress Assessment Instrument (RDAI) score will be reassessed and study interventions are complete. The patient will be observed for one hour in the emergency department (ED). However, further treatments may be started immediately upon discretion of the treating physician. If the patient is discharged home study PI and/or research assistant will call the parents 7 days from the ED visit to check the number of visits to their primary doctor and/or EDs due to same illness.
16117870|NCT02029040|Drug|0.9 % normal saline|Within 5-15 minutes following the administration of the study drug, the Respiratory Distress Assessment Instrument (RDAI) score will be reassessed and study interventions are complete. The patient will be observed for one hour in the emergency department (ED). However, further treatments may be started immediately upon discretion of the treating physician. If the patient is discharged home study PI and/or research assistant will call the parents 7 days from the ED visit to check the number of visits to their primary doctor and/or EDs due to same illness.
16117871|NCT02029027|Device|GYNEFFIK(R)|Vaginal electro-stimulation medical device
16117872|NCT02029027|Other|Usual Care|Any treatment / physiotherapy sessions / muscular training ... usually recommended and/or prescribed by the patient's general practitioner or gynaecologist with the exception of vaginal electro-stimulation
16117873|NCT02029014|Device|LAA closure system|
16117874|NCT02029001|Drug|Nilotinib (400 mg BID)|Patient with advanced pigmented villonodular synovitis and tumors with mutations of ABL1, KIT, PDGFRA, PDGFRB, DDR1, DDR2, CSF1R, or amplification/translocation of the genes and/or of the ligands.
16117875|NCT02029001|Drug|Everolimus (10 mg QD)|Patients whose tumor harbors mutations or amplification of the PIK3CA, PIK3R1, AKT1, AKT2, mTOR, RICTOR, RAPTOR genes, or with TSC1, TSC2 or PTEN loss (defined as complete loss of both gene copies OR loss of one copy + mutation on the other copy or loss of one copy + loss of expression using immunohistochemistry).
16117876|NCT02029001|Drug|Sorafenib (400 mg BID)|Patients whose tumor harbors mutations of VEGFR1-3, PDGFRB, FLT3, BRAF (other than V600 mutations), CRAF, HRAS, KRAS or RET or amplification/translocation of the genes and/or of the ligands.
16117877|NCT02029001|Drug|Lapatinib (1500 mg QD)|Patients whose tumor harbors mutations or amplifications of HER2
16117878|NCT02029001|Drug|Pazopanib (800 mg QD)|Patients whose tumor harbors mutations of VEGFR1-3, PDGFRA, PDGFRB or KIT* or amplification /translocation of the genes and/or of the ligands.
16117879|NCT02029001|Drug|Olaparib (300 mg BID)|Mutation BRCA1/2 (somatic and germline) or BRCA like and mutations of HDR pathway genes (RAD51 family gene, PALB2, ATM, etc...); except in stomach; except for patients eligible to Olaparib's available labels in France.
16117880|NCT02029001|Combination Product|Durvalumab + Tremelimumab|Any molecular types of tumor (which are known to be immunogenic or with high mutation load), except lung, urothelial and head and neck or CNS tumors, or patients who fulfill conditions to receive any other MTT of the MOST Plus study.
16117881|NCT02028988|Drug|Enzalutamide|
16117882|NCT02028988|Radiation|External Beam Radiation|"Dose will be normalized such that exactly 98% of the PTV (planned target volume) receives the prescription dose and will be scored as per protocol. The maximum allowable dose within the PTV is 107% of the prescribed dose to a volume that is at least 0.03 cc. The minimum allowable dose within the PTV is >95% of the prescribed dose to a volume that is at least 0.03 cc.
~EBRT shall receive prescription doses to the PTV 75.6- 79.2 Gy delivered in 1.8 Gy fractions."
16117883|NCT02028975|Other|Measure the threshold of detection for linoleic acid|
16117884|NCT02028975|Other|Oral stimulation tests|
16117885|NCT02028975|Other|Venous blood samples|
16117886|NCT02028975|Other|Samples for genetic studies (ancillary study)|
16117887|NCT02028962|Behavioral|Lifestyle counseling|
16117888|NCT02028949|Drug|Zavedos®|
16117889|NCT02028949|Other|Blood samples|
16117890|NCT02028936|Other|Grape juice R@isol|
16117891|NCT02028936|Other|Commercially-available grape juice|
16117892|NCT02028923|Drug|Morphine gel|Topical
16117893|NCT02028923|Other|Neutral gel|Topical
16117894|NCT02028910|Drug|Ondansetron|"The treatment is administered orally in a single dose of 2.5 ml = 2 mg per 5 kg weight of the child, not to exceed the maximum dose of 10mg. A second dose, the same dose is given back if the child vomits within 15 minutes after the first administration.
~The bottle contains at least 2 doses of up to 10 mg for a second dose can be given back in case of vomiting within 15 minutes after the first dose in children weighing more than 25 kg.
~The dosage should be adjusted according to the weight of the child"
16117895|NCT02028897|Other|Conventional embryo culture|
16117896|NCT02028897|Other|Enclosed embryo culture|
16117897|NCT02028884|Drug|Satralizumab|Satralizumab will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).
16117898|NCT02028884|Drug|Placebo|Placebo will be administered subcutaneously (SC) at Weeks 0, 2, and 4, and thereafter once every 4 weeks (Q4W).
16117899|NCT02028884|Drug|Baseline Treatment|As specified in the protocol, one of the following drugs at a stable dose is required as monotherapy for baseline treatment during the double-blind period: azathioprine (AZA); mycophenolate mofetil (MMF); or oral corticosteroids (CS). For participants aged 12 to 17 years at the time of informed consent, baseline treatment with AZA or MMF in combination with oral CS is also permitted. Change or termination of baseline treatment is only permitted during the open-label extension period.
16117900|NCT02028871|Drug|Intranasal Insulin|
16117901|NCT02028871|Drug|Placebo|
16118337|NCT02025192|Drug|Tucatinib|Administered twice per day, orally.
16117902|NCT02028845|Device|Biliary cannulation with loop guidewire|Selective biliary cannulation during endoscopic retrograde cholangiopancreatography
16117903|NCT02028845|Device|Biliary cannulation with straight guidewire|Selective biliary cannulation during endoscopic retrograde cholangiopancreatography
16117904|NCT02028832|Procedure|PIM consult and service provision|If service is requested, treatment options include acupuncture/acupressure, massage, and reiki
16117905|NCT02028832|Procedure|Usual care|Usual care consists of all conventional care options in pediatric oncology including medication and other therapies.
16117906|NCT02028819|Drug|Dolutegravir Sodium Monohydrate|Dolutegravir taken 50mg orally twice daily
16117907|NCT02028819|Drug|Ibalizumab|Ibalizumab will be administered intravenously at a dose of 800mg once every two weeks.
16117908|NCT02028806|Drug|mFOLFIRINOX|Patients will receive mFOLFIRINOX every 2 weeks: Oxaliplatin 65 mg/m2 IV over 3 hours on Day 1; Irinotecan 150 mg/m2 IV over 90 minutes on Day 1; Leucovorin(l-LV) 200 mg/m2 IV over 2 hours on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion.
16117909|NCT02028780|Drug|Placebo to dose|placebo
16117910|NCT02028780|Drug|Idarucizumab|short infusion
16117911|NCT02028780|Drug|Placebo to Idarucizumab|Placebo to Idarucizumab
16117912|NCT02028780|Drug|dabigatran|2 capsules dabigatran
16117913|NCT02028780|Drug|Idarucizumab|short infusion
16117914|NCT02028767|Drug|Empagliflozin 2.5 mg|Empagliflozin 2.5 mg tablet
16117915|NCT02028767|Drug|Empagliflozin 10 mg|Empagliflozin 10 mg tablet
16117916|NCT02028767|Drug|Metformin 500 mg|Metformin 500 mg tablet
16117917|NCT02028767|Drug|Empagliflozin/Metformin FDC|12.5 mg Empagliflozin / 500 mg Metformin
16117918|NCT02028754|Drug|Sodium Carboxymethylcellulose|Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days post-cataract surgery.
16117919|NCT02028754|Drug|Levofloxacin|Levofloxacin 1 drop in the study eye 3 times a day for 7 days post-cataract surgery.
16117920|NCT02028754|Drug|Prednisolone|Prednisolone 1 drop in the study eye 4 times a day for the 1st week post surgery, 3 times a day for the 2nd week post surgery, 2 times a day for the 3rd week post surgery, and 1 time a day for the 4th week post surgery.
16117921|NCT02028741|Other|Transverse vertebral pressures|Graded transverse mobilization directed to the thoracic spine
16117922|NCT02028715|Drug|Placebo|Normal saline (100cc) will be given IV as the placebo medication every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.
16117923|NCT02028715|Drug|IV acetaminophen|IV acetaminophen (1,000mg) will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.
16117924|NCT02028702|Dietary Supplement|Placebo|water with color
16117925|NCT02028702|Dietary Supplement|Red Clover extract|Red Clover extract containing 80 mg Isoflavones. Dosage: 2 X 75 ml/day
16117926|NCT02028689|Drug|Lesinurad 400 mg|
16117927|NCT02028689|Drug|Metformin 850 mg|
16117928|NCT02028689|Drug|Furosemide 40 mg|
16117929|NCT02028676|Other|Clinically Driven Monitoring (CDM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. Screening results were used to assess eligibility. All subsequent results at and after randomisation were only returned if requested for clinical management (authorised by centre project leaders); haemoglobin results at week 8 were automatically returned on the basis of early anaemia in a previous adult trial as were grade 4 laboratory toxicities (protocol safety criteria). Total lymphocytes and CD4 tests were never returned for CDM participants, but for all children other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
16117930|NCT02028676|Other|Laboratory plus Clinical Monitoring (LCM)|Participants were examined by a doctor and had routine full blood count with white cell differential, lymphocyte subsets (CD4, CD8), biochemistry tests (bilirubin, urea, creatinine, aspartate aminotransferase, alanine aminotransferase) at screening, randomisation (lymphocytes only), weeks 4, 8, and 12, then every 12 weeks. All results were returned to physicians for patient management. Other investigations (including tests from the routine panels) could be requested and concomitant drugs prescribed, as clinically indicated at extra patient-initiated or scheduled visits.
16117931|NCT02028676|Drug|Arm A: ABC+3TC+NNRTI|Children received a standard WHO-recommended regimen of open-label lamivudine, abacavir, plus NNRTI continuously. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age.
16117932|NCT02028676|Drug|Arm B: ZDV+ABC+3TC+NNRTI->ABC+3TC+NNRTI maintenance|Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus NNRTI subsequently. The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age.
16117933|NCT02028676|Drug|Arm C: ZDV+ABC+3TC+NNRTI->ZDV+ABC+3TC maintenance|Children initiated ART using an induction-maintenance approach, starting with open-label four-drug lamivudine, abacavir, NNRTI, plus zidovudine for 36 weeks, then open-label lamivudine, abacavir, plus zidovudine subsequently (triple NRTI maintenance). The NNRTI (nevirapine or efavirenz) was chosen by clinicians according to local availability and age.
16117934|NCT02028676|Drug|Once-daily ABC+3TC|
16117935|NCT02028676|Drug|Twice-daily ABC+3TC|
16117936|NCT02028676|Drug|Continued cotrimoxazole prophylaxis|
16117937|NCT02028676|Other|Stopped cotrimoxazole prophylaxis|
16117938|NCT02028663|Drug|CJ-12420|Once daily, Oral administration
16117939|NCT02028663|Drug|Esomeprazole|Once daily, Oral administration
16117940|NCT02028650|Biological|the first donor's stem cell|HLA-matched stem cell infusion
16117941|NCT02028650|Biological|the second donor's stem cell|HLA-mismatched, the second donor's stem cell infusion
16117942|NCT02028637|Other|TLRs|Recently it has involved the role of TLR (toll-like receptors) in the pathogenesis of asthma.The possible role that TLRs play in the asthma and its recognition as a new endotype asthma, could open new therapeutic expectations.
16118031|NCT02027870|Device|EXCEL-II biodegradable polymer sirolimus-eluting stent|EXCEL-II biodegradable polymer sirolimus-eluting stent implantation
16118032|NCT02027857|Device|EIT monitoring|
16117943|NCT02028624|Behavioral|Nutrition counseling|Patients received nutrition counseling, through one-to-one sessions conducted once a month, until the 6-month evaluation. Nutrition counseling was based on goal-setting and aimed at increasing adherence to Mediterannean diet.
16117944|NCT02028598|Drug|Treatment 1|An oral single dose administration
16117945|NCT02028598|Drug|Treatment 2|An oral single dose administration
16117946|NCT02028598|Drug|Treatment 3|Co-administration of oral single doses
16117947|NCT02028585|Dietary Supplement|Low-fat milk group|
16117948|NCT02028559|Device|Propulse 1|Move kidney stones with Propulse 1 device.
16117949|NCT02028546|Procedure|bathing and moisturizer application|"regimen 1: soaking an arm for 10 minutes, no moisturizer application regimen 2: soaking an arm for 10 minutes,immediate moisturizer application regimen 3: soaking an arm for 10 minutes, delayed moisturizer application for 30 min.
~regimen 4: wait for 10 minutes,no soaking, moisturizer application (moisturizer alone) (All regimens were completed in all patients with 2 visits (7 days interval))"
16117950|NCT02028533|Drug|Oxytocin|
16117951|NCT02028533|Drug|Placebo|
16117952|NCT02028507|Drug|Palbociclib|
16117953|NCT02028507|Drug|Capecitabine|
16117954|NCT02028507|Drug|Exemestane|
16117955|NCT02028507|Drug|Fulvestrant|
16117956|NCT02028494|Drug|Capecitabine|Two dosages comparison
16117957|NCT02028481|Procedure|Postoperative air tamponade|Pars plana vitrectomy, ILM peeling and air tamponade. No postoperative face down positioning. All patients need to be pseudophakic prior to intervention.
16117958|NCT02028468|Procedure|hemiarthroplasty|
16117959|NCT02028455|Biological|Patient Derived CD19 specific CAR T cells also expressing an EGFRt|Defined Composition CD4 and CD8 T cells Lentivirally Transduced to Express a Second Generation 4-1BB:zeta CD19 CAR and EGFRt
16117960|NCT02028442|Biological|Enadenotucirev|Oncolytic virus
16117961|NCT02028429|Drug|Sildenafil.|Arm 1 :Sildenafil Drug Dosage: 25 mg once a day for one week followed by 25 mg twice daily for two weeks then 25 mg thrice daily for one week.
16117962|NCT02028416|Drug|ATG-fresenius|"we will create 2 arms as per randomization table. Both arms will receive ATG-Fresenius but with 2 different regimens.
~the first arm will receive ATG-F @10mg/kg for 3 days and second arm will receive ATG-F same dose but for 5 days"
16117963|NCT02028403|Drug|BMS-936559|0.3 mg/kg, 1 mg/kg, 3 mg/kg, or 10 mg/kg of BMS-936559, depending on which cohort participants are enrolled in, administered as an intravenous (IV) infusion
16117964|NCT02028403|Drug|Placebo for BMS-936559|Sodium chloride for injection 0.9%, USP, administered as an IV infusion
16117965|NCT02028390|Device|Scout takes visual and thermal images of external wounds|All images are taken after the wound has acclimated.
16117966|NCT02028390|Device|ImageReview's visual perimeter trace of the external wound|Trace is drawn by the study staff using the ImageReview software.
16117967|NCT02028390|Device|ImageReview's External Wound Trace Overlay|Study staff overlay the trace of the visual external wound's perimeter onto the corresponding thermal image of the external wound.
16117968|NCT02028390|Device|ImageReview's unaffected reference area selected|Study Staff select an unaffected reference area of an adjacent body surface.
16117969|NCT02028390|Device|Adjacent tissue trace of the wound trace overlay|Study staff select an adjacent tissue trace of the wound trace overlay
16117970|NCT02028377|Procedure|PET/MRI|PET/MRI
16117971|NCT02028364|Drug|Everolimus|10mg orally daily
16117972|NCT02028364|Drug|Exemestane|25mg orally daily
16117973|NCT02028338|Combination Product|placebo ring|intravaginal ring silicone elastomer intravaginal ring containing no drug product
16117974|NCT02028338|Combination Product|dapivirine ring|intravaginal ring silicone elastomer intravaginal ring containing 25 mg dapivirine
16117975|NCT02028325|Drug|Fluorescein Sodium|All patients enrolled in the study will prepare for surgery as per standard neurosurgical indications, procedures and institution protocols. At the time of the anesthesia induction, with the patient under general anesthesia, Fluorescein Sodium 10% (100mg/1mL) at a dose of 3-20 mg/kg will be administered intravenously (the optimal dosage will be determined within the study as the most minimal dose for adequate visualization will be used). For vascular lesions, fluorescein sodium 10% (100mg/1mL) will be injected and used to assess its application after the conventional methods have confirmed the exclusion of the aneurysm. No patient's care will be affected by the results of the Fluorescein angiography.
16117976|NCT02028312|Drug|Loteprednol etabonate|
16117977|NCT02028312|Drug|Artificial Tears|
16117978|NCT02028312|Drug|Restasis|
16117979|NCT02028299|Procedure|2D doppler echo with Definity solution|Correlate right heart catheterization results with results from 2D doppler echo with Definity Solution
16117980|NCT02028286|Drug|CLS001|
16117981|NCT02028260|Drug|Modafinil|200 mg daily
16117982|NCT02028260|Drug|Placebo|similar appearing inert tablet
16117983|NCT02028247|Behavioral|Personalized Cognitive-behavioral therapy|
16117984|NCT02028247|Behavioral|Standard Practice Cognitive-behavioral therapy|
16117985|NCT02028234|Drug|Pantoprazole,|os, 20 mg, once per day, for 30 days
16117986|NCT02028234|Drug|Omeprazole|os, 20 mg, once per day, for 30 days
16117987|NCT02028221|Drug|Metformin|metformin 850 mg 1 tablet taken by mouth daily X 4 weeks, then metformin 850 mg 1 tablet taken twice daily for the duration of he intervention period.
16117988|NCT02028221|Drug|Placebo|1 tablet daily by mouth X 4 weeks, then 1 tablet twice daily by mouth for the remaining duration of the trial (12 months)
16117989|NCT02028208|Diagnostic Test|Ammoniated mercury|Metal allergen panel containing ascending doses of ammoniated mercury and a negative control.
16117990|NCT02028208|Diagnostic Test|Aluminum chloride and aluminum lactate|Metal allergen panel containing ascending doses of alumium chloride, aluminum lactate and a negative control.
16117991|NCT02028208|Diagnostic Test|Sodium tetrachloropalladate|Metal allergen panel containing ascending doses of sodium tetrachloropalladate and a negative control.
16118033|NCT02027857|Device|non-invasive ICP monitoring|
16118034|NCT02027844|Behavioral|Cartoon|Cartoon watching by children during inhalational induction of sevoflurane
16118035|NCT02027844|Behavioral|parental presence|parental presence during inhalational induction of sevoflurane
16118036|NCT02027831|Drug|Indocyanine Green|
16118595|NCT02023229|Other|High-fiber high protein diet|
16117992|NCT02028195|Other|Health check|"The program includes four components:
~Invitation: All participants receive invitation by mail and a prefixed appointment time. A web-based questionnaire including self-reported health (SF12), physical activity, smoking habits and alcohol use/behaviour has to be answered before Health Examination (HE).
~The HE include: Blood pressure, waist, weight, lung function test, lipid profile, HbA1c and fitness (Aastrand).
~Health profile pamphlet: The participant receives a pamphlet with the results. The persons are stratified into three groups (I) referral to a consultation in general practice (GP) (II) targeted behavioural programs at the health centre (HC) or (III ) no identified need for health promoting follow-up.
~Follow-up according to risk-profile: If referred to GP treatment of risk conditions or diseases will follow national guidelines. The GPs were paid 50 Euros per health interview."
16117993|NCT02028182|Biological|Lyral®|Alergen panel containing ascending doses of Lyral (0.10 mg/cm^2, 0.20 mg/cm^2 and 0.40 mg/cm^2) and negative control
16117994|NCT02028156|Other|Partially Hydrolyzed Infant Formula|Commercially available infant formula
16117995|NCT02028143|Device|Biosense Webster irrigated tip catheter|The second group (study group) will have the ICE catheter placed through one of two existing 8F sheaths already in the left atrium. The ICE catheter will be exchanged in the sheath utilizing the lasso multipolar mapping catheter during left pulmonary vein ablation lines. During exchange, suction and irrigation techniques will be utilized to avoid any air or thrombus embolization. All patients will have standard anticoagulation during the procedure with heparin infusion adjusted to an activated clotting time (ACT) of 350-400. The left sided ICE catheter will be adjusted to visualize left sided structures, ablation tip and tissue interface, and adjacent noncardiac structures such as the esophagus during radiofrequency ablation of the left pulmonary vein system.
16117996|NCT02028143|Device|Biosense Webster irrigated tip catheter|Group 1 will receive standard pulmonary vein isolation (PVI) procedure utilizing intracardiac guided ultrasound (ICE) placed within the right atrium via the femoral vein.
16117997|NCT02028143|Procedure|Pulmonary vein isolation|
16117998|NCT02028143|Procedure|ICE catheter placed through one of two existing 8F sheaths|
16117999|NCT02028130|Procedure|LAA electrical isolation + occlusion|LAA electrical isolation + Watchman device implantation to occlude LAA
16118000|NCT02028117|Biological|Enadenotucirev|Oncolytic Virus
16118001|NCT02028104|Biological|Autologous bone marrow mononuclear cell transplantation|bone marrow derived mononuclear cells are administered intrathecally in traumatic brain injury patients
16118002|NCT02028078|Drug|Insulin human|Induces hypoglycaemia
16118003|NCT02028065|Drug|Sugammadex|Sugammadex 4 mg/kg or 16 mg/kg administered as a single IV bolus over 10 seconds
16118004|NCT02028065|Drug|Placebo|Placebo administered as a single IV bolus over 10 seconds
16118005|NCT02028052|Procedure|ROSE|The procedure will proceed with conventional EBUS-TBNA sampling of the target lesion with 22 gauge Vizishot needles. Each subject will be randomized to either ROSE by cytopathologist or no ROSE.
16118006|NCT02028052|Device|22 gauge Vizishot needles|
16118007|NCT02028039|Drug|IPI-145|75 mg orally twice daily for 4 weeks.
16118008|NCT02028039|Behavioral|Follow-up Visit/Call|Follow-up visit 30 days after last dose of study drug. If patient cannot make it to the clinic for this visit, they may speak by phone with a member of the study staff. This phone call should last about 10 minutes.
16118009|NCT02028026|Drug|Vilazodone|10mg/day for 1 week, 20 mg/day for 1 week, and then 40 mg/day for 6 weeks.
16118010|NCT02028026|Drug|Citalopram|20 mg/day for 2 weeks and then 40 mg/day for 6 weeks
16118011|NCT02028000|Procedure|Insorb staples skin closure|Patients will be randomized to Insorb staples skin closure and compared to Monocryl and Vicryl group.
16118012|NCT02028000|Procedure|Monocryl skin closure|Patients will be randomized to Monocryl skin closure and compared to Insorb skin closure and Vicryl skin closure.
16118013|NCT02028000|Procedure|Vicryl skin closure|Patients will be randomized to Vicryl skin closure and compared to Insorb and Monocryl skin closure groups.
16118014|NCT02027987|Drug|valproate acid|valproate acid is a common drug which is applied for epilepsy prevention and treatment.
16118015|NCT02027974|Device|Iconacy Hip System|Comparison of Iconacy I-Hip system to the Stryker Accolade hip system using a randomized study.
16118016|NCT02027974|Device|Stryker Accolade Hip System|Comparison of Iconacy I-Hip system to the Stryker Accolade hip system using a randomized study.
16118017|NCT02027961|Biological|Durvalumab|Intravenous dose of 3 or 10 mg/kg durvalumab.
16118018|NCT02027961|Drug|Dabrafenib|Oral dose of 150 mg dabrafenib capsule.
16118019|NCT02027961|Drug|Trametinib|Oral dose of 2 mg trametinib tablet.
16118020|NCT02027948|Other|nutritional and functional assessments|"Patients will undergo nutritional & functional assessments along the continuum of their chemoradiotherapy treatment. The initial assessment will be measurements of height, weight, & baseline weight loss. Patients will receive chemotherapy & radiation as per standard practice at MSKCC, which is induction chemotherapy for approximately 3 weeks, followed by concurrent chemoradiotherapy. A commonly used regimen is weekly carboplatin (AUC 2) with paclitaxel (50 mg/m2) & radiation consisting of 5040 cGy over 28 fractions. Patients in this study will undergo assessments at three time points (at baseline, after induction chemotherapy, & post-treatment.) At baseline, all patients will complete the functional assessment, dysphagia scale, & Mini- Nutritional Assessment (MNA). According to the baseline MNA score, patients will be categorized as normal nutrition, at risk for malnutrition, or malnourished & receive the appropriate intervention."
16118021|NCT02027935|Biological|Aldesleukin|Given SC
16118022|NCT02027935|Biological|Autologous CD8+ Melanoma Specific T Cells|Given IV
16118023|NCT02027935|Drug|Cyclophosphamide|Given IV
16118024|NCT02027935|Biological|Ipilimumab|Given IV
16118025|NCT02027935|Other|Laboratory Biomarker Analysis|Correlative studies
16118026|NCT02027922|Other|Fluor Protector S|Fluor Protector S intervention group A (25 ml) Duraphat group B (25ml)
16118027|NCT02027909|Device|Reprogramming dual chamber pacemaker|Reprogramming rate response feature in the Medtronic pacemaker to each arm with crossover
16118028|NCT02027896|Other|Accelerated medical clearance and surgery|Rapid medical clearance with targeted arrival to the operating room within 6 hours of diagnosis of a hip fracture requiring surgical repair.
16118029|NCT02027883|Device|Nominal T shock setting|Nominal Parameter Set 1 Programming Values for EnTrust
16118030|NCT02027883|Device|Educated T shock setting|Experimental Parameter Set 2 Programming Values
16118037|NCT02027818|Drug|Indocyanine Green|Observation of the correlation between fluorescence and margins of the tumour after IV injection of ICG
16118038|NCT02027805|Biological|T-Guard|
16118039|NCT02027792|Other|Cabbage leave wraps|
16118040|NCT02027792|Drug|Diclofenac Gel|
16118041|NCT02027779|Biological|GreenGene™ F|"Prophylaxis safety and efficacy substudy:
~intra venous infusion, 30 ± 10 IU/kg infusions 3 times per week with dose escalation to 45 ± 10 IU/kg if appropriate, for 50 exposure days"
16118042|NCT02027779|Biological|GreenGene™ F|"On-demand safety and efficacy substudy:
~minor bleed = 20 ± 10 IU/kg moderate bleed = 30 ± 10 IU/kg major bleed = 30 - 50 IU/kg"
16118043|NCT02027766|Other|Calf muscle stretching|
16118044|NCT02027753|Drug|INSULIN GLARGINE|Pharmaceutical form: solution Route of administration: subcutaneous
16118045|NCT02027753|Drug|Metformin|Pharmaceutical form: tablet Route of administration: oral
16118046|NCT02027753|Drug|DPP-4 inhibitor|Pharmaceutical form: tablet Route of administration: oral
16118047|NCT02027753|Drug|Sulphonylurea|Pharmaceutical form: tablet Route of administration: oral
16118048|NCT02027740|Dietary Supplement|almond|
16118049|NCT02027727|Other|No Intervention|no intervention- tihs is an observational study
16118050|NCT02027701|Biological|IgPro20|
16118051|NCT02027688|Other|q6 hour oral feeding schedule|The intervention is the schedule under which stable infants are offered oral feeding attempts: every 6 hours.
16118052|NCT02027688|Other|q3 hour oral feeding schedule|The intervention is the schedule under which stable infants are offered oral feeding attempts: every 3 hours.
16118053|NCT02027675|Other|High fat poor micronutrient meal|The meal will be prepared by a team of nutritionist in order to comply with the demand characteristics of an high fat poor micronutrient meal.
16118054|NCT02027675|Other|Mediterranean meal|The meal will be prepared by a team of nutritionist in order to comply with the demand characteristics of an Mediterranean meal
16118055|NCT02027662|Drug|Osvaren Granules|
16118056|NCT02027662|Drug|Osvaren film-coated tablets|
16118057|NCT02027636|Behavioral|Engagement and Counseling for Latinos (ECLA-F)|The Engagement and Counseling for Latinos - Face-to-face (ECLA-F) intervention is a cognitive behavioral therapy (CBT) plus care-management intervention delivered in person. The CBT component consists of 6-8 sessions, delivered by a Master's level clinician, and focusing on self-management techniques, problem-solving, and techniques for managing depression and stress. The care-management component of the intervention consisted of monitoring, assistance in scheduling appointments, and help with transportation. This intervention was identical to the telephone (ECLA-F) intervention, except for the delivery method.
16118058|NCT02027636|Behavioral|Engagement and Counseling for Latinos (ECLA-T)|The Engagement and Counseling for Latinos - Telephone (ECLA-T) intervention is a cognitive behavioral therapy (CBT) plus care-management intervention delivered via telephone. The CBT component consists of 6-8 sessions, delivered by a Master's level clinician, and focusing on self-management techniques, problem-solving, and techniques for managing depression and stress. The care-management component of the intervention consisted of monitoring, assistance in scheduling appointments, and technical assistance. This intervention was identical to the face-to-face (ECLA-F) intervention, except for the delivery method.
16118059|NCT02027623|Behavioral|Motor skill training|The participant will assist in selecting both simple and complex functional activities to practice. Difficulty will be graded to match the participant's motor capabilities. Three activities will be practiced per session. Within the practice of activities the training will emphasize 1) contraction of groups of specific trunk muscles, 2) earlier and greater movement of the hip, knee, and/or thoracic spine relative to the lumbar spine, 3) later and less movement of the lumbar spine relative to other regions. Within each activity the conditions of practice will vary based on 1) the participant's ability to perform the activity, and 2) the level of challenge the participant is faced with when performing the activity during his day. Equipment will be provided as needed.
16118060|NCT02027623|Behavioral|Strength and flexibility exercise|Exercises based on best evidence for effectiveness in people with chronic low back pain will be prescribed. Strengthening exercises will target all trunk muscles. Flexibility exercises will target all trunk and hip motions. All exercises will be performed at the intensity appropriate for the person's musculoskeletal fitness level based on the American College of Sports Medicine guidelines. Difficulty level, frequency, and number of repetitions will be modified based on guidelines described in the literature. Equipment will be provided as needed.
16118061|NCT02027597|Other|Attack of the S. Mutans|A research assistant led groups of students through the Attack of the S. Mutans exhibit. All participants played all the games and viewed all the graphical content of the exhibit.
16118062|NCT02027597|Other|Follow-up|This group experienced the Attack of the S. Mutans! exhibit and 3 doses of follow-up booster content at a web site.
16118063|NCT02027597|Other|SnowWorld|SnowWorld is a 3D first-person-shooter game developed by Firsthand Technology. In SnowWorld, the player shoots snowballs at penguins, polar bears, and other features of a frozen landscape. The game is designed to help burn victims cope with pain, and has no oral health messages.
16118064|NCT02027584|Other|collection of remnant of clinically indicated blood sample|collection of remnant of clinically indicated blood sample
16118065|NCT02027571|Behavioral|Intensive Lifestyle Intervention (ILI)|ILI consists of weight loss ( > 10%); caloric reduction; physical activity (180 min/week); monthly visits for group counseling for 6 months, followed by quarterly visits; and meal replacements.
16118066|NCT02027558|Behavioral|Insomnia treatment & PAP adherence|Manual-based cognitive behavioral treatment focusing on sleep, sleep apnea, and PAP adherence provided by allied health personnel in individual sessions.
16118067|NCT02027558|Behavioral|General sleep education|Manual-based non-directive general sleep education program provided by allied health personnel in individual sessions.
16118068|NCT02027545|Behavioral|Decision Aid|Printed booklet comprising educational information about benefits and harms of screening, individualized estimates of benefits and harms of screening, and values clarification exercise
16118069|NCT02027545|Behavioral|Provider Education|Providers of patients in both arms of the study will be given an educational module about recent data on the benefits and harms of screening how these data fit in with existing population-centered guidelines.
16118184|NCT02026609|Other|Oral glutamine challenge|Blood ammonia determination before, 30-, 60-, and 90-minute, after intake of 10 g of L-glutamine
16118070|NCT02027545|Behavioral|Performance Measure Modification|The clinical reminder system will be modified so to facilitate documentation of informed decision making about CRC screening, including specific reasons for not screening. Additionally, providers who indicate a specific exception for not screening (using the modified clinical reminder) will be considered as satisfying the requirements and will not be penalized in terms of performance pay, and will be removed from feedback reports that encourage population screening.
16118071|NCT02027545|Behavioral|Simple Informational Booklet|A simple informational booklet explaining colorectal cancer screening and current screening recommendations.
16118072|NCT02027532|Drug|Cefazolin|
16118073|NCT02027532|Drug|Vancomycin|
16118074|NCT02027519|Other|HIV Self-testing with Standard Counseling and Testing (SCT) Confirmation|"Partners of the index participants and other household members will be offered HIV self-testing by the mobile testing team. Those who consent to HIV self-testing with SCT confirmation will complete the following procedures:
~Undergo standardized pre-test counseling and demonstration of use of HIV rapid test kit by trained study staff, including how to determine test results
~Self-administer HIV rapid test and read test results
~Provide study staff with self-testing result
~Undergo confirmatory testing as well as post-test counseling by study staff (SCT) if the initial self-test is positive, there is any doubt about the results, or the test reveals couple discordance"
16118075|NCT02027493|Drug|Reiferon R|subcutaneous injection of 100 μg/m2
16118076|NCT02027493|Drug|Ribavirin|15 mg/kg daily on two divided doses
16118077|NCT02027467|Dietary Supplement|StemAlive®|
16118078|NCT02027467|Dietary Supplement|Placebo (For StemAlive®)|
16118079|NCT02027454|Drug|GSK1265744|White to slightly colored film coated tablet with unit dose strength of 30 mg and dose level of 150mg (5 tablets of 3 mg) administered orally every 12hours for 3 doses.
16118080|NCT02027454|Drug|GSK1265744 matching placebo|GSK1265744 matching placebo tablets administered orally every 12hours for 3 doses (5 tablets per dose).
16118081|NCT02027454|Drug|Moxifloxacin|Dull red, oblong, convex film coated tablets with unit dose strength of 400 mg administered orally as a single dose.
16118082|NCT02027441|Other|Standard Counseling and Testing|"Individuals who opt for standard counseling and testing will complete the following procedures:
~• Standardized pre- and post-test counseling and HIV testing using HIV rapid test per approved national guidelines"
16118083|NCT02027428|Drug|Abraxane (Induction)|100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 and 15 of each 21-day cycle, administered as standard of care
16118084|NCT02027428|Drug|Carboplatin (Induction)|6 mg/min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion
16118085|NCT02027428|Drug|Abraxane (Maintenance)|100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 of each 21-day cycle, administered as standard of care
16118086|NCT02027428|Other|Best Supportive Care (Maintenance)|The best palliative care per investigator (including but not limited to: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and/or focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis), excluding antineoplastic agents
16118087|NCT02027428|Drug|Abraxane (Induction)|100 mg/m2 IV infusion over 30 minutes on Days 1 and 8 and 15 of each 21-day cycle, administered as standard of care
16118088|NCT02027428|Drug|Carboplatin (Induction)|6 mg/min/mL IV on Day 1 of each 21-day cycle after completion of nab-paclitaxel infusion, administered as standard of care
16118089|NCT02027428|Other|Best Supportive Care (Maintenance)|The best palliative care per investigator (including but not limited to: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and/or focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis), excluding antineoplastic agents
16118090|NCT02027415|Dietary Supplement|Beet juice|2 cups of beet juice will be given before the car ride
16118091|NCT02027415|Dietary Supplement|Orange juice|2 cups of orange juice will be given before the car ride
16118092|NCT02027402|Procedure|Laparoscopic cholecystectomy with drain insertion|In the drain insertion group, investigators use the closed suction drain through a lateral 5-mm trocar and placed it in right subhepatic space
16118093|NCT02027376|Drug|LDE225|
16118094|NCT02027376|Drug|Docetaxel|
16118095|NCT02027363|Drug|Capecitabine|maintenance with apecitabine，1,000 mg/m2 twice a day， days1-15，every 3 weeks，until progression, unacceptable toxicity, or patient withdrawal.
16118096|NCT02027363|Other|Observation|Patients with metastatic colorectal cancer who achieved objective response or stable disease after 4-6 months first-line chemotherapy would stop the chemotherapy and observation
16118097|NCT02027350|Device|CD Leycom/Millar Instruments conductance catheter|Conductance catheter-Pressure volume relationship
16118098|NCT02027337|Drug|20 mcg ethinylestradiol /3 mg drospirenone|One contraceptive pill in each day of 28 day cycle. Number of Cycles: 12
16118099|NCT02027337|Drug|20 mcg ethinylestradiol/3 mg drospirenone and Selmevit|One contraceptive pill in each day of 28 day cycle. Number of Cycles: 12. Two pills of Selmevit in each day during 30 days, repeat of the course every 3 months.
16118100|NCT02027337|Drug|30 mcg ethinylestradiol/3 mg drospirenone|One contraceptive pill in each of 21 days, than 7 days break. Number of Cycles: 12
16118101|NCT02027337|Drug|30 mcg ethinylestradiol/3 mg drospirenone and Selmevit|One contraceptive pill in each of 21 days, than 7 days break. Number of Cycles: 12 Two pills of Selmevit in each day during 30 days, repeat of the course every 3 months.
16118102|NCT02027337|Drug|35 mcg ethinylestradiol/2 mg cyproterone|1 contraceptive pill in each day of 28 day cycle. Number of Cycles: 12
16118103|NCT02027337|Drug|35 mcg ethinylestradiol/2 mg cyproterone and Selmevit|One contraceptive pill in each day of 28 day cycle. Number of Cycles: 12. Two pills of Selmevit in each day during 30 days, repeat of the course every 3 months.
16118104|NCT02027324|Drug|Chlorhexidine-alcohol group|2% chlorhexidine in 70% isopropyl alcohol in accordance with manufacturer's instructions for safe usage.
16118105|NCT02027324|Drug|Povidone-Iodine Group|10% Povidone-Iodine for surgical antisepsis according to manufacturer's instructions.
16118106|NCT02027311|Drug|Etomidate|This cohort would be administered etomidate with meperidine. The initial dose of etomidate is 0.1mg/kg IV and meperidine, 25mg. Additional dose of etomidate is 2mg(1cc). In old age cased, more than 65 years old, 30% of initial dose discounted.
16118185|NCT02026609|Other|Psychometric Tests|PHES (portosystemic hepatic encephalopathy score) and ICT (inhibitory control test)
16118107|NCT02027311|Drug|Midazolam|This cohort would be administered midazolam with meperidine. The initial dose of midazolam is 0.06mg/kg IV and meperidine 50mg IV. Additional dose is 1mg of midazolam. In the elders, more than 65 years old, initial dose was declined to 70%.
16118108|NCT02027311|Drug|Meperidine|Both groups were administered same dose of meperidinie 50mg. Then elders > 80 years old were administered 25mg iv bolus.
16118109|NCT02027298|Drug|Abatacept|by SC injection of 125 mg weekly for 6 months
16118110|NCT02027285|Dietary Supplement|fortified milk|"FortifiedUltra-high temperature (UHT), partly-skimmed milk (1.6% fat), highly digestible (lactose <0.5%) produced by Granarolo s.p.a. supplemented with long chain unsaturated fatty acids DHA (Docosahexaenoic acid) +EPA (Eicosapentaenoic acid), vitamin D, B12, B6, B9, E,C, Zinc and Selenium versus placebo Ultra-high temperature (UHT), partly-skimmed milk (1.6% fat), highly digestible (lactose <0.5%) of the same manufacturer.
~The nutrients added are: DHA + EPA 1.4 mg/ml; vitamin D3 0.068 mcg/ml; B6 6.4 mcg/ml; B12 0.01 mcg/ml; B9 (folic acid) 0.80 mcg/ml; vitamin E 0.05 mg/ml; vitamin C 0.19 mg/ml; Zinc 0.04 mg/ml; Selenium 0.22 mcg/ml. The protein content of the milk is 0.04 g/ml."
16118111|NCT02027272|Drug|Dexamethasone|Intravenous Dexamethasone 12 mg, 2 doses, 12 hours apart
16118112|NCT02027259|Behavioral|Behavioral activation (BA)|The addition of Behavioral activation (BA) to our group visits in patients with DM and depression will consist of 4 weekly group visits of 2-hour duration followed by monthly booster group visits for 6 months to prevent relapse.
16118113|NCT02027246|Biological|Autologous bone marrow mononuclear cell transplantation|Bone marrow is aspirated by a standard procedure. Mononuclear cells are separated by density gradient method and then injected intrathecally by a standard lumbar puncture procedure
16118114|NCT02027233|Other|nasopharyngeal sample|The nasopharyngeal sample will be used to find the types and subtypes of influenza virus and other respiratory viruses (VRS, SARS-CoV-2 and others).
16118115|NCT02027220|Drug|G-CSF|G-CSF Intracutaneous injection (IC) on days 0, 1, 7, 8, 14, 15, 21 and 22, every four weeks.
16118116|NCT02027220|Drug|Bortezomib|Bortezomib Intravenous injection (IV) on days 1, 8, 15 and 22, every four weeks.
16118117|NCT02027220|Drug|Cyclophosphamide|Cyclophosphamide, Continuously Intravenous injection (CIV) on days 1, 8, 15 and 22, every four weeks.
16118118|NCT02027220|Drug|Dexamethasone|Dexamethasone Intravenous injection (IV) on days 1, 2, 8, 9, 15, 16, 22 and 23, every four weeks.
16118119|NCT02027207|Biological|Shanchol|"We will use the killed whole cell oral cholera vaccine, Shanchol that will be manufactured by Shantha Biotechnics, in Hyderabad, India for the study. The vaccine is registered in India and is prequalified by the WHO. Shanchol is available in a single dose vial. Vaccine will be maintained at 2-8oC. Each participant over the age of one year and non pregnant females living in communities will be individually randomized to receive vaccine.Pregnancy status will be enquired verbally for all married women of child bearing age during the census update as well as before vaccination to exclude them from the study.
~Prior to vaccination, informed consent will be taken from the adults and guardians of minor participants .Each dose of vaccine will be 1.5 ml in volume."
16118120|NCT02027207|Biological|Placebo|Placebo will be transported from the manufacturer and will be maintained at 2-8oC. Each participant over the age of one year and non pregnant females living in communities will be individually randomized to receive placebo.Each dose of placebo will be 1.5 ml in volume.Placebo will be dispensed in liquid form in identical vials.
16118121|NCT02027194|Drug|Cure-Allergic Rhinitis Syrup|Delivered one bottle for two weeks to the participants twice
16118122|NCT02027194|Drug|Yu-ping-fung San|Delivered one bottle for 2-week usage to the participants twice
16118123|NCT02027194|Drug|Placebo|Delivered one bottle (wheat power with favors) for 2-week usage to the participants twice
16118124|NCT02027181|Device|Device FreeO2 v2.0|"Automatic adjustment of oxygen through the Free O2 device.
~FreeO2 device in mode medical data collecting(SpO2,EtCO2...)."
16118125|NCT02027181|Device|Device FreeO2 v2.0|"Manual adjustment of oxygen without the assistance of the FreeO2 device.
~Only FreeO2 device in mode medical data collecting(SpO2,EtCO2...)."
16118126|NCT02027168|Other|CPA|Site specific, patient centered manual physical therapy regimen focused on restoring function to the entire body
16118127|NCT02027155|Drug|AR09 solution|moderate levels of sedation
16118128|NCT02027155|Drug|placebo|Sterile Saline, USP
16118129|NCT02027142|Other|Pittsburgh Sleep Quality Index.|"Pittsburgh Sleep Quality Index is an effective instrument used to measure the quality and patterns of sleep of patients. It allows evaluating poor from good sleep by assessing seven domains. A total score ≤ 5 indicated good sleep quality while a total score > 5 was indicated poor sleep quality."
16118130|NCT02027142|Other|Epworth sleepiness scale.|Epworth sleepiness scale is an 8-item questionnaire developed to measure average daytime sleepiness. A total score ≥ 10 indicates excessive daytime sleepiness.
16118131|NCT02027142|Other|Insomnia Severity Index.|Insomnia Severity Index is a 7-item questionnaire developed to measure insomnia. A total score between 0 and 7 correspond to not clinically significant insomnia, between 8 and 14 to subthreshold insomnia, between 15 and 21 to clinical insomnia (moderate), between 22 and 28 to clinical insomnia (severe).
16118132|NCT02027142|Other|The Endometriosis Health Profile.|The Endometriosis Health Profile is a patient generated instrument that evaluates disease-specific health-related quality of life in patients with endometriosis. The questionnaire is administrable to all patients with endometriosis and it consists in 30 items divided in 5 domains (pain, control and powerlessness, emotional well-being, social support and self-image). Each scale for each domain is comprised between 0 (indicating the best health status) and 100 (indicating the worst health status).
16118133|NCT02027129|Other|High Frequency Oscillation|Comparison of low frequency HFO/HFO-TGI with cuff leak and high frequency HFO without cuff leak on right ventricular function
16118134|NCT02027116|Biological|VGX-6150|Plasmid DNA delivered via IM injection with electroporation
16118135|NCT02027103|Drug|Metformin|Metformin 1000 mg fixed dose, twice daily (500 mg tablets x 2)
16118136|NCT02027103|Drug|Pioglitazone|Pioglitazone 30 mg fixed dose, twice daily (15 mg tablets x 2)
16118137|NCT02027090|Drug|Routine dose icotinib|Icotinib is administered 125 mg three times daily.
16118138|NCT02027090|Drug|Higher dose icotinib|After 8-week induction of icotinib with a dose of 125 mg three times daily, icotinib is administered 375 mg three times per day.
16118186|NCT02026596|Procedure|Magnetic resonance imaging|
16118378|NCT02024880|Device|Conventional catheter group|A standard embryo catheter
16118139|NCT02027077|Behavioral|Control group|No prescribed intervention/ Participants asked to follow normal initiatives to engage in physical activity a healthful diet behaviors for the duration of the intervention
16118140|NCT02027077|Behavioral|Lifestyle counselling|Participants will follow a prescribed behavioral intervention program seeking small changes in both physical activity and diet for the duration of the intervention.
16118141|NCT02027064|Drug|Interferon-alpha|
16118142|NCT02027038|Device|Pelvic belt application|
16118143|NCT02027025|Drug|SPARC1103 low dose|once daily
16118144|NCT02027025|Drug|SPARC1103 high dose|once daily
16118145|NCT02027025|Drug|SPARC Placebo|
16118146|NCT02027012|Device|Percutaneous renal denervation with the Vessix™ Renal Denervation System|
16118147|NCT02026986|Behavioral|sleep deprivation|sleep deprivation for one night
16118148|NCT02026973|Drug|Fulvestrant|
16118149|NCT02026973|Drug|Anastrozole|
16118150|NCT02026973|Drug|Placebo|
16118151|NCT02026973|Drug|Somatostatin|
16118152|NCT02026960|Device|RNA extraction and amplification from biopsy specimens|
16118153|NCT02026947|Drug|Sodium Benzoate|0.5 g/day during the first week, 1.0 g/day for the next 11 weeks. One capsule at the morning for the first week. One capsule at the morning and one at the evening for 2-12 weeks.
16118154|NCT02026947|Drug|Placebo|
16118155|NCT02026934|Device|CliniMACS CD34 Reagent System|Following screening and enrollment, peripheral blood or bone marrow collection will be performed on the donor followed by subsequent CD34+ cell selection using the Miltenyi CliniMACS device. There is no limit to the number of CD34+ progenitors that can be administered. The CD34+ selected cells will be infused within 12 hours of the initiation of processing.
16118156|NCT02026921|Drug|Carboplatin|Carboplatin, AUC5, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: 6 or until progression or unacceptable toxicity develops
16118157|NCT02026921|Drug|Docetaxel|75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: 6 or until progression or unacceptable toxicity develops.
16118158|NCT02026908|Device|Prostate Artery Embolization|Procedure completed in Interventional Radiology includes a pelvic/prostate angiogram and embolization with Embosphere microspheres to slow/block blood flow to the prostate.
16118159|NCT02026895|Genetic|Genetic blood sample|
16118160|NCT02026882|Device|Supreme Laryngeal Mask Airway|Supreme Laryngeal Mask Airway. Preoxygenation, rapid sequence induction and cricoid pressure. Induction of general anaesthesia.
16118161|NCT02026869|Drug|Metformin|Metformin is taken either orally or vaginally every 12 hours
16118162|NCT02026856|Drug|sodium selenite pentahydrate|
16118163|NCT02026856|Other|placebo - continuous saline NaCl 50 ml|
16118164|NCT02026817|Drug|HCP1201 750/10mg|750mg Metformin/10mg rosuvastatin fixed dose combination tablet orally in the morning on day1 or day8.
16118165|NCT02026817|Drug|Metformin SR 750mg|Co-administration of Metformin 750mg and Rosuvastatin 10mg orally in the morning on day1 or day8.
16118166|NCT02026817|Drug|Rosuvastatin 10mg|Co-administration of Metformin 750mg and Rosuvastatin 10mg orally in the morning on day1 or day8.
16118167|NCT02026791|Device|I-gel|"The patient was monitored at 1-5 minute intervals.
~While supplying oxygen through a mask, propofol 1.0mg/kg and remifentanil 0.5ug/kg were intravenously injected to induce anesthesia. When consciousness was not lost, propofol 0.5mg/kg was additionally injected. After consciousness was lost and spontaneous respiration disappeared, rocuronium 0.3 mg/kg was intravenously injected while performing manual ventilation.
~After injecting an anesthetic and muscle relaxant, the injection concentration of fresh gas including 6 L/min oxygen and desflurane was regulated to maintain BIS between 40 and 60. A train of four (TOF) was performed with a nerve stimulator for muscle relaxation monitoring to verify that a muscular contraction did not take place (TOF=0).
~Then, with the assistance of another anesthesiologist, I-gel prepared in advance was inserted."
16118168|NCT02026791|Device|Supreme-LMA|"The patient was monitored at 1-5 minute intervals.
~While supplying oxygen through a mask, propofol 1.0mg/kg and remifentanil 0.5ug/kg were intravenously injected to induce anesthesia. When consciousness was not lost, propofol 0.5mg/kg was additionally injected. After consciousness was lost and spontaneous respiration disappeared, rocuronium 0.3 mg/kg was intravenously injected while performing manual ventilation.
~After injecting an anesthetic and muscle relaxant, the injection concentration of fresh gas including 6 L/min oxygen and desflurane was regulated to maintain BIS between 40 and 60. A train of four (TOF) was performed with a nerve stimulator for muscle relaxation monitoring to verify that a muscular contraction did not take place (TOF=0).
~Then, with the assistance of another anesthesiologist, Supreme LMA prepared in advance was inserted."
16118169|NCT02026778|Drug|ondansetron|"The ondansetron group is given placebo (pyridoxin) instead of betahistine.
~The ondansetron group is given ondansetron 4 mg bolus at the end of surgery and ondansetron 8 mg added to the IV-PCA."
16118170|NCT02026778|Drug|ondansetron-betahistine|"The ondansetron-betahistine group is given betahistine 18mg orally in the morning of surgery and postoperative day 1.
~The ondansetron-betahistine group is given ondansetron 4 mg bolus at the end of surgery and ondansetron 8 mg added to the IV-PCA."
16118171|NCT02026765|Device|traditional lens|A random eyes with traditional lens
16118172|NCT02026765|Device|heparin surface modified aspheric lens|the other eye implant heparin surface modified aspheric lens
16118173|NCT02026739|Procedure|low supplemental oxygen concentration|low supplemental oxygen concentration would be used during the surgery
16118174|NCT02026739|Procedure|high supplemental oxygen concentration (conventional)|high supplemental oxygen concentration would be used during the surgery
16118175|NCT02026713|Other|quit smoking for a 2 weeks period|evaluate the platelet reactivity after 15 days by quit smoking
16118176|NCT02026700|Device|bariederm cream|patients are asked to apply twice a day a barrier cream on their hands for 3 weeks only
16118177|NCT02026687|Drug|Epidural|
16118178|NCT02026687|Drug|Intrathecal|
16118179|NCT02026674|Device|FloRite|Disposable home use urine flow meter.
16118180|NCT02026622|Behavioral|psychometric tests|NEO-PI, MADRS, MINI depression, MMSE, STAI-E, ERD, Anhedonia
16118181|NCT02026622|Device|MRI|ASL, rest f-MRI, FLAIR, white matter hyper intensities load
16118182|NCT02026622|Device|transcranial doppler and TPI|transcranial doppler TPI
16118183|NCT02026622|Behavioral|explicitative interview|
16118628|NCT02022930|Device|Hydros-TA|
16118187|NCT02026596|Procedure|Cerebral microdialysis catheter insertion|Is inserted only when invasive intracranial pressure monitoring is required. The same route with pressure probe is used for insertion.
16118188|NCT02026583|Drug|Simvastatin|
16118189|NCT02026570|Behavioral|Internal Focus of Attention|Providing instructions for the user to manipulate their residual limb in space during standing and walking tasks.
16118190|NCT02026570|Behavioral|External Focus of Attention|Providing instructions for the user to manipulate their prosthetic foot in space during standing and walking tasks.
16118191|NCT02026544|Device|Low Frequency Therapeutic Ultrasound|29 kHz (kilohertz) low frequency therapeutic ultrasound delivered transcutaneously
16118192|NCT02026531|Other|3-Helium gas|3-Helium gas for MRI contrast
16118193|NCT02026518|Dietary Supplement|Soy isoflavones|
16118194|NCT02026518|Dietary Supplement|cholecalciferol|
16118195|NCT02026518|Dietary Supplement|Placebo of soy isoflavones|
16118196|NCT02026518|Dietary Supplement|placebo of cholecalciferol|
16118197|NCT02026505|Drug|Bortezomib|
16118198|NCT02026492|Other|Exercise challenge in a cold chamber|Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in a cold chamber.
16118199|NCT02026492|Other|Methacholine challenge|nebulized metacholine administered at following doses: 0,01mg, 0,1mg, 0,4mg, 0,8mg und 1,6mg
16118200|NCT02026492|Other|Exercise challenge in room temperature|Exercise challenge is defined as running on a treadmill for 6-8 minutes on submaximal work load in room temperature.
16118201|NCT02026479|Drug|Dexamethasone Phosphate|5mg; postauricular injection
16118202|NCT02026479|Drug|Dexamethasone Phosphate|10mg; postauricular injection
16118203|NCT02026479|Drug|Ginaton|40mg/pill, 3times/day,oral
16118204|NCT02026453|Other|Pharmacist obtains admission medication history|
16118205|NCT02026453|Other|Pharmacy technician obtains admission medication history|
16118206|NCT02026414|Dietary Supplement|PrimaVie|Subjects will take 250 mg of PrimaVie (herbal supplement manufactured by Natreon, Inc) twice a day for the first 8 weeks they are enrolled in the study. For the last 4 weeks of the study, subjects will take 250 mg of PrimaVie (herbal supplement manufactured by Natreon, Inc) supplement twice a day while also completing supervised exercise on a treadmill (70-75% of maximum Heart Rate for 20 mins, plus 5 minutes of warm up and 5 minutes of cool down exercises for a total of 30 minutes a day 3 days a week). Subjects will participate for a total of 12 weeks and come for three total visits. At each visit, subjects will have muscle biopsies taken from their thigh or calf as well as approximately 2 tablespoons of blood drawn.
16118207|NCT02026414|Other|Exercise|
16118208|NCT02026401|Biological|NGM282|
16118209|NCT02026401|Biological|Placebo|
16118210|NCT02026362|Biological|MASCT:Multiple Antigens Specific Cellular Therapy|autologous immune cytotoxic of T-lymphocytes (CTL) induced by dendritic cells, (DC) loaded with multiple antigens DC loaded with survivin p53 her2 ect total 17 antigens .
16118211|NCT02026362|Other|The foundation treatment including against hepatitis b virus treatment using nucleoside analogue drug and protect liver treatment|
16118212|NCT02026349|Drug|favipiravir|"Administered twice daily over 5 consecutive days for a total of 10 doses.
~Day 1: 1800 mg twice daily (loading doses)
~Days 2 through 5: 800 mg twice daily"
16118213|NCT02026349|Drug|Placebo|Administered twice daily over 5 consecutive days for a total of 10 doses.
16118214|NCT02026336|Other|electronic nose|"Exhaled gas to assess e-nose VOC profiles was collected as described. Briefly, patients breathed through a mouthpiece into a 2-way nonrebreathing valve (Hans rudolph 2700, Hans rudolph, Kansas City, Mo) with an inspiratory VOC filter and an expiratory silica reservoir to dry the expired air. Expiratory air was collected in a 10-L Tedlar bag. Within not more than 10 minutes, the bag was connected to the e-nose device (Cyranose 320®; Smith Detections, Pasadena, CA), provided with a 32 organic polymeric nano-composite sensor array, for 5 minutes and changes in the nano-sensor electrical resistance generated a breath-print VOC profile."
16118215|NCT02026323|Other|acupuncture|acupuncture
16118216|NCT02026310|Drug|glimepiride|on the basis of metformin and glargine, glimepiride is added; with the maximun dose of glimepiride, if the targeted FPG is not reached, glargine dose will be increased.
16118217|NCT02026310|Drug|glargine and metformin|
16118218|NCT02026297|Drug|Tranexamic Acid|1 gram IV over 10 minutes
16118219|NCT02026297|Drug|Placebo; Normal Saline|0.9% Normal Saline
16118220|NCT02026284|Other|Questionnaire|A questionnaire was performed to gravid women who are to deliver, regarding theri anesthesia preferences.
16118221|NCT02026271|Biological|Ad-RTS-hIL-12|"2.0 x 10^11 viral particles (vp) per injection or 1.0 x 10^12 viral particles (vp) per injection
~one intratumoral injection of Ad-RTS-hIL-12"
16118222|NCT02026271|Drug|veledimex|"4 doses (20mg/day, 40mg/day, 80mg/day, and 120mg/day)
~14 oral daily doses of veledimex
~1 Expansion cohort at a single dose level at or below MTD"
16118223|NCT02026258|Procedure|Piezotome-Corticision|Local anesthetic will be administered to the labial sulcus of the mandibular incisors. A scalpel will be used to make three vertical incisions through the gingiva, 4mm below the interdental papilla, interproximally between mandibular canines and lateral incisors, and central incisors on the labial aspect of the mandible. The incisions will be 4mm in length. A piezosurgery knife will be used to create the cortical alveolar incisions to a depth of 1mm within the cortical bone. The depth of the cortical incision will be limited to 1mm for a safety margin. Postoperatively, subjects will be advised to rinse with chlorhexidine mouthwash twice a day for one week and take acetaminophen as needed.
16118224|NCT02026258|Device|Orthodontics|Subjects will be followed every 4-5 weeks after the first wire placement until full alignment of the lower arch (irregularity index 0-2mm). The archwire sequence will be 0.014-in Cu-NiTi wire for the first two visits followed by a 0.014 X 0.025-in Cu-NiTi wire until completion of alignment.
16118225|NCT02026245|Device|Data gloves to perform movements|"Using the electronic data gloves to perform a set routine of movements:
~5DT 'dataglove 14 Ultra' Electronic glove (commercially available)
~New 'Tyndall/UU' developmental dataglove"
16118226|NCT02026232|Drug|Hydroxychloroquine|200mg twice daily
16118227|NCT02026232|Other|Hydroxychloroquine Placebo|200mg placebo twice daily
16118228|NCT02026219|Drug|Clopidogrel|Clopidogrel 600mg loading
16118229|NCT02026219|Drug|Ticagrelor|Ticagrelor 180mg loading
16118263|NCT02025907|Drug|Canagliflozin, 300 mg|One 300 mg capsule taken orally (by mouth) once daily.
16118230|NCT02026206|Device|low-level light therapy|we used a skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule.
16118231|NCT02026206|Device|Placebo|we used a placebo skin-adhesive LLLT device called the Color DNA-WSF (Color Seven Co., Seoul, Korea) which consists of body for power supply and two microprocessor-controlled light-emitting diodes. We selected two acupuncture points, conception vessel 4 (CV4; Guanyuan) and CV6 (Qihai), for treating dysmenorrhea. The participants attached the placebo skin-adhesive LLLT device probes to both acupuncture points according to treatment schedule.
16118232|NCT02026193|Procedure|oocyte vitrification|
16118233|NCT02026193|Procedure|embryo freezing|
16118234|NCT02026180|Device|Micropuncture Access|Femoral arterial access will be obtained either with a 21G micropuncture needle kit or an 18G standard access needle.
16118235|NCT02026167|Behavioral|Collaborative Care|Addition of a Health Care Assistant to treatment team, case review by expert panel of supervisors, non-medical interventions
16118236|NCT02026141|Drug|Dexmedetomidine|
16118237|NCT02026141|Drug|Normal Saline Placebo|
16118238|NCT02026115|Behavioral|PAINReportIt|PAINReportIt is a software program first developed with an electronic MPQ (1970 version) and now includes questions about analgesics used by the patient and a shortened version of the pain Barriers Questionnaire (BQ). PAINReportIt is designed as an interactive, touch screen method for assessment of pain. It can be self-administered and requires little or no patient computer experience and minimal or no provider time for administration. Directions for self-administration allow the patient to read instructions on-screen and practice making all types of selection responses that are available in the program. Directions from the paper and pencil tools were modified to address the touch screen method of recording patient responses. The copyright is owned by Dr. Ronald Melzack for the MPQ and Dr. Sandra Ward for the BQ. Both of these individuals have authorized the modifications, presentation format, and computerized use of their tools.
16118239|NCT02026115|Behavioral|PAINConsultN|PAINConsultN for hospice nurses. Our previous studies support the feasibility and clinical effect of PAINConsultN. This narrative and graphic tool provides decision support for the nurse's clinical decisions regarding management of the patient's pain. Based on the PAINReportIt output and published cancer pain guidelines, PAINConsultN generates an algorithm-based consultation report with a list of recommendations that could be useful to provide improved pain relief. If the patient's PAINReportIt output indicates the pain level is consistent with the patient's goals for pain management and represents no pain or a mild pain level, the consultation report acknowledges the therapy plan and reinforces its consistency with pain guidelines.
16118240|NCT02026115|Behavioral|PAINUCope|We tested the prototype of the PAINUCope component of the intervention in three completed studies. PAINUCope is a multimedia, computer generated tool that provides tailored patient information to overcome their misconceptions about pain and to help them engage in self-care activities that contribute to reducing their pain. PAINUCope focuses on two crucial aspects of pain management: 1) reporting cancer pain; and 2) safe and effective use of pain medicines. All the educational materials were written at a 6th grade reading level and presented as 21st Century best-practices, evidence-based facts or scripts for the person living with cancer or sickle cell disease (in one study). The facts or scripts are customized to the patient's need for this type of health information. The patient's responses on PAINReportIt govern the specific health information that is shared with the patient via PAINUCope.
16118241|NCT02026102|Behavioral|ICD Decision Aid Toolkit|Research assistants will provide patients with a toolkit of decision aids. Participants will have the option of using all of the decision aids or just some of the decision aids.
16118242|NCT02026089|Biological|Varicella vaccine|Varivax 0.5ml subcutaneous injection
16118243|NCT02026076|Other|mechanical lumbar traction|15 minutes at up to 50% body weight lumbar traction in supine hooklying with split table open
16118244|NCT02026063|Drug|Telotristat etiprate|Telotristat etiprate tablet (250 mg)
16118245|NCT02026050|Procedure|intraarticular dexamethasone|2ml 8 mg dexamethasone administration for intraarticular
16118246|NCT02026050|Procedure|interscalene dexamethasone|2ml 8 mg dexamethasone administration interscalene brachial plexus added 30 ml 0.5 % bupivacaine
16118247|NCT02026050|Procedure|serum phsyologic|interscalene brachial plexus block was preoperative performed 30 ml 0.5 % bupivacaine+ 2ml serum phsyologic and after surgery 10 ml serum phsyologic administration for intraarticular
16118248|NCT02026037|Behavioral|Brief Treatment for Acutely Burned Patients (BTBP)|Brief Treatment for Acutely Burned Patients (BTBP) adapts CBT principles that have been validated with non-burn trauma survivors to the treatment of hospitalized burn patients. BTBP consists of three 1 to 1½ hour sessions per week for two weeks, as well as two sessions for family members or partners/spouses.
16118249|NCT02026011|Drug|Naltrexone|Naltrexone is an opioid receptor antagonist with highest affinity for mu opioid receptors
16118250|NCT02026011|Drug|Placebo|Sugar pill, matched to the active study medication in capsule size and color
16118251|NCT02025998|Drug|Ibudilast|Ibudilast is a glial cell modulator that inhibits phosphodiesterases -4 and -10 and macrophage migration inhibitory factor.
16118252|NCT02025998|Other|Matched placebo|A matched placebo (suggar pill) will be administered as a control condition.
16118253|NCT02025985|Drug|Selinexor|"Route of administration and dosage form: Oral tablet; Doses: 35 mg/m^2 BIW, 35 mg/m^2 QW, 50 mg/m^2 BIW, 50 mg/m^2 QW, 60 mg/m^2 BIW, 60 mg/m^2 QW.
~Treatment cycles were 4 weeks each i.e., 28 day cycles."
16118254|NCT02025972|Procedure|Allogeneic umbilical cord blood therapy|
16118255|NCT02025959|Behavioral|Educating hospital staff on good sleep hygiene for patients and screening for sleep disorders|
16118256|NCT02025933|Other|Salmon Group|The children are advised to eat at least 75g of salmon per serving, but no more than 150g
16118257|NCT02025933|Other|Cod Group|The children are advised to eat at least 75g of cod per serving, but no more than 150g
16118258|NCT02025933|Other|Meat Group|The children are advised to eat at least 75g of meat per serving, but no more than 150g
16118259|NCT02025920|Other|Salmon Group|
16118260|NCT02025920|Other|Cod Group|
16118261|NCT02025920|Other|Meat Group|
16118262|NCT02025907|Drug|Canagliflozin, 100 mg|One 100 mg capsule taken orally (by mouth) once daily.
16118265|NCT02025881|Drug|Carboplatin + etoposide|"Carboplatin 160 mg/m2 Day 1 to day 5 As an intravenous infusion over 1 hour. Dilution in 5 % glucose saline or sodium chloride 9 mg/ml (0.9%).
~Etoposide 100 mg/m2 D ay 1 to day 5 As an intravenous infusion over 1 hour. Dilution in physiological saline or 5 % glucose saline while not exceeding a concentration of 0.4 mg/ml etoposide in the infusion bottle."
16118266|NCT02025881|Drug|Thiotepa|Thiotepa 200 mg/m² Day-3 to day-1 As an intravenously infusion over 1 hour dilution in 200 ml/m² of 5% glucose saline or sodium chloride 9 mg/ml (0.9%)
16118267|NCT02025881|Drug|Cyclophosphamide + Busilvex|"Cyclophosphamide Level 1 20 mg/kg/day Level 2 30 mg/kg/day Level 3 40 mg/kg/day Level 4 50 mg/kg/day
~Busilvex < 9 kgs 0.8 mg/kg/dose - 3.2 mg/kg/day 9 à < 16 kgs 0.96 mg/kg/dose - 3.84 mg/kg/day 16 à 23 kgs 0.88 mg/kg/dose - 3.52 mg/kg/day > 23 à 34 kgs 0.76 mg/kg/dose - 3.04 mg/kg/day > 34 kgs 0.64 mg/kg/dose"
16118268|NCT02025868|Behavioral|adherence reinforcement|Directly observed treatment at home (family or relatives DOT); pillboxes; phone calls; SMS; home visits; adherence reinforcement sessions by trained health workers.
16118269|NCT02025868|Drug|Antiretroviral Therapy Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators)|"Second-line ART regimen : ongoing regimen at the time of inclusion will be continued.
~Third-line ART regimen : Darunavir/r + Raltegravir + 2 NRTIs (as chosen by the investigators)"
16118270|NCT02025855|Drug|Methadone|
16118271|NCT02025855|Drug|Placebo|
16118272|NCT02025803|Drug|TAS-114/capecitabine|"Part 1 (dose-escalation phase):
~Treatment cycles of TAS-114 and capecitabine orally BID for 14 days followed by 7 days rest until at least one of the discontinuation criteria are met TAS-114 dose starting at 20mg/m2/day with capecitabine dose of 760 mg/m2/day. TAS-114 doses will be escalated for each cohort up to 480mg/m2/day. If MTD is not reached by TAS-114 dose of 480mg/m2/day, the capecitabine dose will be escalated
~Part 2 (expansion phase):
~TAS-114 and capecitabine MTD established in Part 1 administered BID for 14 days followed by 7-day recovery period (21-day cycle)."
16118273|NCT02025790|Procedure|Per Oral Endoscopic Myotomy (POEM)|"Mucosal incision - After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 12 cm proximal to the gastroesophageal junction (GEJ).
~Submucosal tunneling. A long submucosal tunnel is created to 3 cm distal to the GEJ.
~Endoscopic myotomy is begun at 3 cm distal to the mucosal entry point, and is carried out in a proximal to distal direction to a total length of 10 cm.
~Long endoscopic myotomy is performed 10 cm proximal to GEJ extending
~Closure of mucosal entry: the mucosal incision is closed using hemostatic clips"
16118274|NCT02025790|Procedure|Pneumatic Dilatation|Pneumatic dilatation using a Rigiflex balloon up to 35 mm at 8 psi for 1 minute.
16118275|NCT02025777|Device|Capsule Endoscopy|
16118276|NCT02025751|Drug|Metoclopramide Nasal Spray|One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID)
16118277|NCT02025751|Drug|Placebo Nasal Spray|One placebo spray dose 30 minutes before meals and before bed for 28 days (QID)
16118278|NCT02025738|Device|MAGNET APPLICATION|
16118279|NCT02025738|Device|REPROGRAMING|
16118280|NCT02025738|Device|NO ACTION|
16118281|NCT02025725|Drug|Metoclopramide Nasal Spray|nasal spray formulation of metoclopramide
16118282|NCT02025725|Drug|Placebo Nasal Spray|nasal spray formulation with vehicle only
16118283|NCT02025712|Drug|Exemestane|Commercially available exemestane was supplied to sites as 25-mg tablets according to local regulations.
16118284|NCT02025712|Drug|Everolimus|Everolimus was administered by continuous oral dosing of two 5-mg tablets or one 10-mg tablets.
16118285|NCT02025686|Drug|Hyperbaric Oxygen|Subjects will breathe oxygen (FIO2 = 1.0) at 2.4 ATA in a hyperbaric chamber after the tonic heat stimulations. The duration of oxygen exposure is 90 min.
16118286|NCT02025686|Other|Normal ambient conditions|Normal ambient conditions (1 ATA, FIO2 = 0.21)
16118287|NCT02025660|Drug|Mw, 0.3ml x three days sc|
16118288|NCT02025660|Drug|Placebo|
16118289|NCT02025634|Drug|Intravenous Acetaminophen|Participants randomized to intravenous acetaminophen (Ofirmev) will receive an infusion of Ofirmev in 100 ml of 0.9 NS according to manufacturer's recommendations related to subject's weight.
16118290|NCT02025634|Drug|Placebo (0.9% Normal Saline infusion)|Infusion of 100 ml of 0.9% NS
16118291|NCT02025621|Drug|Levosimendan|
16118292|NCT02025621|Drug|Placebo|matching placebo
16118293|NCT02025608|Drug|Pramipexole|
16118294|NCT02025608|Drug|Placebo|
16118295|NCT02025582|Device|Kinesio Tape of the Ankle|Tibialis anterior facilitation/ gastrocnemius inhibition: Taping to be worn 3-5 days and repeated x 1
16118296|NCT02025569|Other|Strain Counterstrain|
16118297|NCT02025569|Other|Sham strain counterstrain|
16118298|NCT02025556|Biological|LBR-101 High Dose|Subcutaneously Administered High Dose LBR-101 Monthly x 3
16118299|NCT02025556|Biological|LBR-101 Low Dose|Subcutaneously Administered Low Dose LBR-101 Monthly x 3
16118300|NCT02025556|Biological|Placebo|Subcutaneously Administered Placebo (Vehicle) Monthly x 3
16118301|NCT02025543|Device|MRI|R2 MRI scan
16118302|NCT02025530|Other|Questionnaire|An indepth interview will be carried out and a structured questionnaire will be completed by both cases and controls
16118303|NCT02025517|Other|Cognitive Tasks.|The Experimental Group underwent treadmill gait training simultaneously to a protocol of cognitive tasks created specifically for this study, based on cognitive activities proposed in previous studies. The training sessions lasted 20 minutes. The first three minutes allowed subjects to familiarize themselves with the treadmill. From the 4th minute onward, the volunteer walked for 1 minute while performing cognitive tasks, and in the following minute, only walked. Thus, the 17 remaining minutes on the treadmill alternated between one minute of treadmill training combined with a cognitive task and the following minute only treadmill training. Treadmill gait speed was that reported by the patient as the fastest possible speed while maintaining a suitable comfort level.
16118304|NCT02025504|Device|ColoWrap|ColoWrap is an abdominal binder intended as an accessory to facilitate colonoscopy.
16118334|NCT02025231|Radiation|External beam radiotherapy|Study group 1: 3.5 Gray x 10, 5 fractions per week. Study group 2: 3.5 Gray x 10 + 7 Gray boost to biological target volume, 5 fractions per week. Study group 3: 5.9 Gray x 10, 5 fractions per week. Study group 4 (planning target volumes: 100 millilitres - 300 millilitres): 3.5 Gray x 10, 5 fractions per week. Phase II dosis: to be chosen based on results of phase I study.
16118335|NCT02025218|Drug|Gefitinib standard dose|
16118305|NCT02025491|Drug|Liposomal Amphotericin B|Liposomal Amphotericin B will be administered by intravenous route, 3 to 5 mg/kg/day, during 7 to 14 days of treatment. Complete hemogram, aminotransferases (AST, ALT), blood urea and creatinine will be determined in all patients on days -1, and three times/week up to the end of therapy. Patients will bemonitored for side effects daily. Patients will be followed-up at 1, 2, 3, 4 and 6 months post-therapy. Clinical and laboratory adverse events will be graded according to the Common Toxicity Criteria (CTC) of the National Cancer Institute.
16118306|NCT02025478|Dietary Supplement|Breastmilk|"A registered dietician will supervise milk provision, and additional calories will be provided by addition of the supplement Prolacta. To make 28 kcal/oz milk, 40 ml of Prolacta will be mixed with 60 ml human milk to make a total volume of 100 ml.
~If a nursing mother enrolls on the study, maternal and not donor milk will be given in the maximum volume possible, with Prolacta supplementation if clinically indicated and recommended by the registered dietician."
16118307|NCT02025465|Drug|Metoprolol|"The attending ED physician may use higher or lower intravenous doses depending on patient response as this is the norm in clinical practice for these two medications used for decades for AF/FL rate control.
~Conversion of intravenous to oral, chronic management will be left to the discretion of the ED or managing medical team."
16118308|NCT02025465|Drug|Diltiazem|"The attending ED physician may use higher or lower intravenous doses depending on patient response as this is the norm in clinical practice for these two medications used for decades for AF rate control.
~Conversion of intravenous to oral medication for rate control for chronic management will be left to the discretion of the ED or managing medical team."
16118309|NCT02025452|Other|Rapid diagnostic|Specimens from rectal mucosa will be obtained using flocked swabs at enrolment. Those in 'rapid diagnostic' groups will have them tested using multiplex PCR the day of enrolment and participants with treatable pathogens will have antimicrobials provided. Those in 'delayed diagnostic' groups will have the swabs batched at tested at the conclusion of the study, being treated as per standard of care.
16118310|NCT02025452|Dietary Supplement|Probiotic|Lactobacillus reuteri suspended in vegetable oil, 5 drops/day (1 x 10e8 CFU) x 2 months
16118311|NCT02025452|Other|Placebo|Identical in appearance to L. reuteri probiotic (same bottle), but simply vegetable oil. Dose is 5 drops/day x 2 months.
16118312|NCT02025439|Device|rTMS|
16118313|NCT02025439|Drug|Amantadine|
16118314|NCT02025426|Drug|Phenylephrine|
16118315|NCT02025426|Drug|Ephedrine|
16118316|NCT02025413|Device|Mesenchymal-marker based ferrofluid (N-cadherin or O-cadherin based)|
16118317|NCT02025400|Other|eRehab|"Growth in e-Health applications, defined as any computer or Internet application integrated into health services, has resulted in the development of treatment strategies to improve healthcare while reducing costs. The utilization of e-Health to provide a rehabilitative intervention has recently been identified in the cardiac literature as e-rehabilitation or eRehab. This study specifically compares an orthopedic eRehab Internet application to standard outpatient physical therapy as an adjunct in the treatment of non-complicated knee and shoulder disorders."
16118318|NCT02025400|Other|Formal Physical Therapy|This intervention involves referral to a licensed physical therapist or supervised ATC-L.
16118319|NCT02025387|Behavioral|Physical activity feedback|
16118320|NCT02025387|Behavioral|Usual care except physical activity measurement|
16118321|NCT02025374|Drug|Hyperbaric levobupivacaine|
16118322|NCT02025374|Drug|Hyperbaric bupivacaine % 0.5|
16118323|NCT02025361|Drug|intrarectal lidocaine gel|intrarectal local anesthetic application
16118324|NCT02025361|Drug|periprostatic nerve blockade|periprostatic local anesthetic application
16118325|NCT02025348|Drug|IntelliCap|Drug release from the IntelliCap® system will be actuated post-gastric emptying of IntelliCap® capsule.
16118326|NCT02025322|Behavioral|Peer Mentoring|"Participants in the Peer Mentoring arm will be paired with a Peer Mentor for the duration of the 4-month intervention. Peer Mentors are HIV-positive patients who demonstrate high levels of medication and treatment adherence and are knowledgeable about HIV/AIDS and barriers to care. During the 4-month intervention, Peer Mentors will contact participants weekly via in-person, phone, or email, with the option to provide more frequent contact, if needed. Peer Mentors will provide social support and remind participants to take their medications and attend upcoming medical appointments.
~Study participants will also attend four monthly, one hour workshops on HIV/AIDS, medication adherence, health literacy, and health and wellness, which will be developed and co-facilitated by Peer Mentors."
16118327|NCT02025309|Device|Neuromuscular monitorisation|
16118328|NCT02025296|Device|U-healthcare|use of a public switched telephone network (PSTN)-connected glucometer to measure their blood glucose level at the same frequency as the SMBG group
16118329|NCT02025283|Procedure|Group Decompression or Group Nucleoplasty|Group Decompression: Decompression with flexible intradiscal decompression catheter (SpineCATH®, Smith & Nephew, Memphis, TN) Group Nucleoplasty: Nucleoplasty with radiofrequency-compatible needle (Coblation: Perc DLE SpineWandTM [ArthroCare Spine, Sunnyvale, CA]
16118330|NCT02025270|Biological|Stem Cells|60 ml of bone marrow will aspirated and used for stem cells isolation. Then stem cells will cultured using autologous serum, characterized and prepared using GMP rules and finally injected into rete testis.
16118331|NCT02025257|Other|Exercise|Individually prescribed hospital based exercise in group two times a week, home-based exercise once a week. The exercise intervention consists of interval based aerobic exercise on a bicycle ergometer 30 minutes with intensity level at 13-17 at Borg scale, resistance exercises and balance exercises
16118332|NCT02025244|Procedure|Key Hole Biopsy ( KHB)|Patients with endoscopically detected Upper Gastrointestinal Submucosal Tumors with diameter ≥ 2cm are, according to randomization, allocated to undergo esophagogastroduodenoscopy with Key Hole Biopsy consisting of forceps biopsy through mucosal incision by a needle knife, with subsequent cytological /histological and immunohistochemical evaluation of specimen. In the case of Gastrointestinal Stromal Tumors (GIST), the possibility to determine the mitotic activity is evaluated.
16118333|NCT02025244|Procedure|EUS-FNA|Patients with endoscopically detected Upper Gastrointestinal Submucosal Tumors with diameter ≥ 2cm are after randomization allocated to undergo endosonography-guided fine-needle-aspiration biopsy (EUS-FNA) by 22G needle, with subsequent cytological /histological and immunohistochemical examination of the specimen. In the case of Gastrointestinal Stromal Tumors (GIST), the possibility to determine mitotic activity is evaluated. In case of failure of this method, the second one is performed.
16118338|NCT02025192|Drug|Capecitabine|1000mg/m^2 administered twice per day, orally in Days 1-14 of each 21-day cycle.
16118339|NCT02025192|Drug|Trastuzumab|Administered at a loading dose of 8 mg/kg IV followed by 6 mg/kg once every 21 days.
16118340|NCT02025179|Drug|Teriparatide|Teriparatide 20 ug daily Sub-Q over 12 months
16118341|NCT02025179|Device|Vibration|Vibration 10 min/day for 12 months
16118342|NCT02025166|Drug|Paracetamol|"Pain treatment with aniline analgesics (paracetamol) at the time of the procedure"
16118343|NCT02025166|Drug|lornoxicam|"Pain treatment with NSAID (lornoxicam) at the time of the procedure"
16118344|NCT02025153|Other|pain testing|physical testing, psychological testing, genetics testing and functional brain imaging
16118345|NCT02025140|Device|Computer controlled anesthesia|The IANB by the computer controlled local anesthetic device CCLAD and periodontal ligament anesthesia by the CCLAD
16118346|NCT02025140|Device|conventional anesthesia syringe|Active control
16118347|NCT02025127|Other|Enteral nutrition|Enteral nutrition introduced via a feeding tube
16118348|NCT02025114|Drug|selumetinib|The starting dose of selumetinib in combination with the standard dose of gefitinib (250mg QD) on a continuous dosing schedule will be 50mg QD. Total 3 doses of selumetinib will be tested (50mg QD, 50mg BID and 75mg BID).
16118349|NCT02025088|Procedure|Laser|Patients of this arm will undergo three sessions of laser treatment with an interval of six weeks between them. In each laser session, the non-ablative fractional erbium laser 1340 nm ProDeep (Etheria ® platform/Industra) with tip 100mtz/cm ² will be applied across the face, with a power of 120mJ/mtz time and pulse time of 5ms.
16118350|NCT02025088|Procedure|Microneedling|"Patients in this arm will undergo three sessions with microneedling, with an interval of six weeks between them. In the microneedling sessions, the instrument contains 192 microneedles with 2 mm depth, which will be applied to the face in four different directions, making up about 20 movements of coming and going in each direction."
16118351|NCT02025075|Drug|Rocuronium|Rocuronium 0.6 - 1.2 mg/kg with the dose adjusted to achieve 1-2 post-tetanic counts (Deep NMB) or 1-2 twitches in the train-on-four (Moderate NMB).
16118352|NCT02025062|Other|CGA and geriatric follow-up|The CGA is a multidimensional assessment of general health status, using validated scales. It produces an inventory of problems which can then serve to develop an individualized geriatric intervention plan of care and follow-up
16118353|NCT02025049|Drug|DP-b99|DP-b99 is a lipophilic analog of the divalent metal ion chelator O,O'-Bis(2-aminophenyl) ethyleneglycol-N,N,N',N'-tetraacetic acid (BAPTA)
16118354|NCT02025049|Drug|Placebo|mannitol-based DP-b99 look-alike
16118355|NCT02025036|Drug|Capecitabine(Aibin)|capecitabine(Aibin)：625mg/m2, bid d1-5; q1w, po,5 weeks in total
16118356|NCT02025036|Drug|Oxaliplatin(Aiheng)|Oxaliplatin(Aiheng)：65mg/m2，d1，8, 22, 29,I.V.
16118357|NCT02025036|Radiation|Radiotherapy|concurrent radiotherapy： 50Gy in total，2 Gy/d，5d/w，Until disease progression or unacceptable toxicity
16118358|NCT02025023|Drug|5-fluorouracil Injection|If the chalazion is present at follow-up visit, another injection of 5-FU will be given.
16118359|NCT02025023|Drug|Triamcinolone Acetonide|If chalazion present at follow-up, another Triamcinolone injection will be done.
16118360|NCT02025023|Procedure|Incision and Curettage|If chalazion present at follow-up visit, patient will be randomized to receive local injection of either triamcinolone, 5-FU, or triamcinolone/5-FU mixture.
16118361|NCT02025023|Drug|Triamcinolone Acetonide/5-fluorouracil mixture|If chalazion persists at follow-up visit, another injection of triamcinolone/5-FU mixture will be done.
16118362|NCT02025010|Drug|abiraterone acetate|Daily four 250 mg tablets (1,000 mg) of AA taken orally for 28 day cycles. No food should be consumed for at least two hours before the dose and for at least one hour after the dose. The tablets should be swallowed whole with water. Tablets should not be crushed or chewed.
16118363|NCT02025010|Drug|prednisone|Take with food 5 mg Oral Twice daily
16118364|NCT02025010|Procedure|pre-treatment and progression tumor biopsies|Participants will undergo pre-treatment and progression tumor biopsies. After the progression biopsy is performed, protocol therapy will be discontinued. Participants who stop protocol therapy before receiving four cycles of AA will not be asked to undergo the second biopsy.
16118365|NCT02025010|Genetic|assessment of serum corticosteroid intermediates and ACTH|•Participants will undergo assessment of serum corticosteroid intermediates and ACTH at baseline and subsequent treatment visits for correlation with symptoms of mineralocorticoid excess.
16118366|NCT02024997|Other|Magnetic Resonance Imaging (MRI)|
16118367|NCT02024984|Drug|Clomiphene Citrate|"Group A (study group) 'Luteal Clomid': will include 45 patients to whom 100 mg of CC will be administrated daily for five days starting the next day after finishing MPA (medroxyprogesterone acetate) 10 mg tablet for five days, for one menstrual cycle, then a wash out period for another menstrual cycle, then the group treatment plan is shifted to administration of 100 mg of CC daily for five days starting on day 2 of the cycle induced by MPA for another menstrual cycle.
~Group B (control group)'Follicular Clomid': will include 45 patients to whom 100 mg of CC will be administrated daily for five days starting on day 2 of the cycle induced by MPA, for one menstrual cycle, then a wash out period for another menstrual cycle, then the group treatment plan is shifted to administration of 100 mg of CC daily for five days starting the next day after finishing MPA (medroxyprogesterone acetate) 10 mg tablet for five days for another menstrual cycle."
16118368|NCT02024971|Drug|Pioglitazone/metformin hydrochloride|Pioglitazone/metformin hydrochloride combination tablets
16118369|NCT02024945|Drug|Propiverine|Propiverine 15 mg tablets or 30 mg regulated release capsules
16118370|NCT02024932|Drug|BVS857|BVS857 lyophilisate in vial; the lyophilisate was reconstituted with sterile water for injection, diluted as appropriate, and administered either i.v. or s.c..
16118371|NCT02024932|Drug|Placebo|Placebo lyophilisate in vial; the lyophilisate was reconstituted with sterile water for injection, diluted as appropriate, and administered either i.v. or s.c..
16118372|NCT02024919|Drug|intracoronary administration of diltiazem|
16118373|NCT02024919|Drug|intracoronary injection of 5 mL saline|
16118374|NCT02024906|Dietary Supplement|soy protein isolate (SPI)|
16118375|NCT02024906|Dietary Supplement|milk protein isolate (MPI)|
16118376|NCT02024893|Other|Observational study|"Observation and type of data collected are listged in detail under 'description"
16118377|NCT02024880|Device|Protective catheter group|The tip of this catheter is protected on insertion of the catheter.
16118379|NCT02024867|Drug|Trimethoprim-Sulfamethoxazole|3 versus 10 days of drug
16118380|NCT02024854|Behavioral|skin-to-skin|
16118381|NCT02024854|Behavioral|standard care|
16118382|NCT02024841|Drug|Intraperitoneal docetaxel|Intraperitoneal docetaxel, intravenous cisplatin and oral TS-ONE every 3 weeks for 3 cycles then stop
16118383|NCT02024828|Other|Early/Slow|
16118384|NCT02024828|Other|Early/Fast|
16118385|NCT02024828|Other|Late/Slow|
16118386|NCT02024828|Other|Late/Fast|
16118387|NCT02024815|Radiation|External Beam radiotherapy|External Beam radiotherapy
16118388|NCT02024789|Drug|Placebo|Orally twice daily, 26 weeks
16118389|NCT02024789|Drug|RG1662|120 mg (80 mg for subjects 12 and 13 years of age) orally twice daily, 26 weeks
16118390|NCT02024789|Drug|RG1662|240 mg (160 mg for subjects 12 and 13 years of age) orally twice daily, 26 weeks
16118391|NCT02024776|Behavioral|Prehabilitation|Tailored exercise training program
16118392|NCT02024763|Behavioral|Educational Intervention|Intervention was applied to classroom teachers by the multidisciplinary team of the RRIDA Project. Training lasted six weeks, 12 hours devoted to physical activity and 18 hours to nutritional content. Modules of educational activities to classroom teachers were to be replicated at PE classes to children from 1st and 2nd grades of three exposed schools. The physical activity module was based on a theoretical approach of physical activity benefits and risks for health, children's physical fitness and activity patterns, physical education and change behavior models.
16118393|NCT02024750|Behavioral|Tailored Resources|Based upon PRISM screening tool results that identifies self-management barriers, patient/family will receive self-management resources matched to their barriers. These resources could be focused on: 1. Understanding and organizing care; 2. Motivation to self-manage; and 3. Family Teamwork. Group session of about 6 families with the same barrier will meet four times fo 75-minutes over a year, at the clinic site on same date as routine clinic visit.
16118394|NCT02024737|Other|MRI lung imaging (not an intervention per se but the focus of the study)|"The purpose of this pilot study is to determine short and long term reproducibility of a comprehensive set of functional imaging data; using hyperpolarised gas MRI, conventional MRI and lung physiology measurements in patients with moderate to severe COPD. In addition,how sensitive the imaging techniques are to changes in lung function after treatment with a standard (bronchodilator) inhaler will also be assessed (the bronchodilator foradil is a non-investigative medicinal product as it is a medicine with a known effect which will be used to induce a known response).
~This pilot study will serve as a platform for future larger scale studies, aimed at better understanding of and intervention in early COPD."
16118395|NCT02024724|Drug|Bupivacaine|4 mL of 0.25% bupivacaine
16118396|NCT02024724|Drug|Triamcinolone|40 mg of Triamcinolone
16118397|NCT02024724|Drug|Dexamethasone|4 mg of Dexamethasone
16118398|NCT02024711|Device|EYEFILL® C.-US Viscoelastic|EYEFILL ® C.-US is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries.
16118399|NCT02024711|Device|Healon® Viscoelastic (CONTROL)|Healon® is designed for use during cataract extraction and intraocular lens implantation surgery to protect the corneal endothelium, and other intraocular tissues and to manipulate tissues during these anterior chamber ocular surgeries.
16118400|NCT02024698|Device|omafilcon A|contact lens
16118401|NCT02024698|Device|etafilcon A|contact lens
16118402|NCT02024685|Behavioral|Personalized Treatment Recommendations|This is a psychosocial/behavioral study. It will use a randomized trial to test the hypothesis that a decision analysis model that provides individualized estimates of quality-adjusted disease-free survival for each of the treatment options for clinically localized prostate cancer will lead to higher quality treatment decisions congruent with a patient's values leading to improved decisional regret and treatment satisfaction. In this trial, all patients would be evaluated at baseline for their utilities for various clinically important health states. The primary endpoint of this study will be regret-free survival at 2 years after treatment. There will be a 1:1 randomization. A random permuted design will be used to assure approximate balanced number of patients in the two groups over time.
16118403|NCT02024685|Behavioral|Standard patient-physician counseling interaction|Both patients and physicians will be unaware of the decision analysis recommendation and the patients will receive standard treatment counseling alone. After the patient has made a treatment decision he will be given a short questionnaire to assess decisional conflict. If after one month no treatment decision information is available, a letter and form requesting treatment information along with the decisional conflict questionnaire will be sent to patients.
16118404|NCT02024672|Other|Immediate postpartum placement of IUD|pelvic exam, transvaginal ultrasound (3 during the course of the study), bleeding and symptom diary
16118405|NCT02024659|Drug|budesonide|Patients receive 1mg/2ml budesonide twice daily via transnasal nebulization for 14 days.
16118406|NCT02024659|Other|placebo|patients receive placebo (saline solution) 2ml twice daily for 14 days.
16118407|NCT02024646|Drug|210 mg brodalumab|210 mg brodalumab administered via subcutaneous injection.
16118408|NCT02024646|Drug|140 mg brodalumab|140 mg brodalumab administered via subcutaneous injection.
16118409|NCT02024646|Drug|Placebo|Placebo administered via subcutaneous injection until week 24.
16118410|NCT02024633|Drug|icotinib|Three dose levels of icotinib are designed to be evaluated, 125 mg three times per day, 250 mg three times per day, and 375 mg three times per day. Dose escalations are based on predefined dose escalation decision rules. The Maximum Administered Dose (MAD) was reached at the dose level when at least 30% patients developed a dose limited toxicity.
16118411|NCT02024633|Drug|Gemcitabine|Gemcitabine: 1000 mg/m2 on Days 1, 8, and 15 of a 28 day cycle by IV administration every 4 weeks.
16118412|NCT02024620|Behavioral|Behavioral activation plus mobile app|
16118413|NCT02024620|Behavioral|Standard behavioral activation|
16118414|NCT02024607|Drug|BBI608|
16118415|NCT02024607|Drug|Fluorouracil|
16118416|NCT02024607|Drug|Oxaliplatin|
16118417|NCT02024607|Drug|Leucovorin|
16118418|NCT02024607|Drug|Irinotecan|
16118419|NCT02024607|Drug|Bevacizumab|
16118420|NCT02024607|Drug|Capecitabine|
16118421|NCT02024607|Drug|Regorafenib|
16118422|NCT02024594|Drug|Nitrous Oxide-Oxygen conscious sedation|
16118424|NCT02024581|Drug|10% East Indian sandalwood oil cream|A topical oil/water emulsion cream containing 10% East Indian sandalwood oil (EISO)
16118425|NCT02024581|Drug|Placebo Cream|A sandalwood-scented oil/water emulsion topical cream matching the appearance of the active comparator creams
16118426|NCT02024568|Drug|Pregabalin|See arm description
16118427|NCT02024568|Drug|Placebo|See arm description
16118428|NCT02024555|Drug|Levofloxacin|
16118429|NCT02024555|Drug|Ethambutol|
16118430|NCT02024555|Drug|Azithromycin|
16118431|NCT02024555|Drug|Rifampin|
16118432|NCT02024555|Drug|Placebo|This will serve as a placebo to the antibiotics used in antimycobacterial therapy.
16118433|NCT02024542|Other|Surgery|Patients wishing to participate in the research will complete all necessary pre-operative work-up labs, testing & counseling, complete and sign the informed consent. During weight loss surgery a small amount of subcutaneous and omental fat will be collected for analysis, with subsequent blood collection post surgery for analysis.
16118434|NCT02024529|Biological|Ampion|kDa ultrafiltrate of 5% human serum albumin
16118435|NCT02024529|Biological|Placebo|Saline
16118436|NCT02024516|Other|50 gr concentrated pomegranate juice|
16118437|NCT02024477|Drug|Saxagliptin|5 mg tablet once daily for 12 weeks
16118438|NCT02024477|Drug|Placebo|1 tablet daily for 12 weeks
16118439|NCT02024464|Device|Hydrus Microstent|Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.
16118440|NCT02024464|Device|iStent Trabecular Micro Bypass|Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.
16118441|NCT02024451|Device|Radial shock wave|radial shock wave: Treatment point is the origin attachment of upper trapezius at the external occipital protuberance. Radial shock wave therapy will be performed once per week, and will be continued for 3 weeks. Acetaminophen will be prescribed as rescue medication, and the amount given will be recorded at the end of the study.
16118442|NCT02024451|Device|Acupuncture|Acupuncture is performed at Fenfchi (GB20) point over upper back by the same physiatrist to all patients.
16118443|NCT02024438|Drug|monosialotetrahexosylganglioside Sodium|it is extracted from pig's brain,shenjie is the brand name
16118444|NCT02024438|Other|placebo|saline of the same appearance as monosialotetrahexosylganglioside Sodium
16118445|NCT02024425|Dietary Supplement|Functional bioactive supplement|1,25g of antioxidant extracted from rosemary, 18g of oligosaccharides derived from lactulosa and 1,25g of bioactive peptides
16118446|NCT02024425|Dietary Supplement|Control supplement|
16118447|NCT02024412|Drug|monosialotetrahexosylganglioside Sodium|it is a component extract from pig's brain,shenjie is the brand name
16118448|NCT02024412|Other|placebo|saline of the same appearance as monosialotetrahexosylganglioside Sodium
16118449|NCT02024399|Other|Exercise|Strength training, aerobic exercise and core strengthening, running
16118450|NCT02024386|Drug|Riociguat|After completion of first V02 max test at altitude, subjects will have a 3-hour rest period. Riociguat will be administered at the 90-minute mark of this rest period.
16118451|NCT02024373|Drug|Atorvastatin|20 mg (every evening orally) for 8 weeks
16118452|NCT02024373|Drug|placebo|20 mg (every evening orally) for 8 weeks
16118453|NCT02024360|Behavioral|Patient navigation|16 session (25 hour) home-based intervention with patient navigators encouraging families to adopt healthy eating, active living and parental skill building
16118454|NCT02024334|Drug|Leflunomide|
16118455|NCT02024308|Drug|Fludarabine|50 mg/m2, IV (in the vein) in combination with cytarabine 1.4mg/m2/d for 5 days with each cycle of 28 days. Number of cycles: 4
16118456|NCT02024308|Drug|Cytarabine|2000mg/m2/12h, IV (in the vein) for 3 days with each cycle of 28 days. Number of cycles: 4
16118457|NCT02024295|Drug|Ademethionine|ademethionine 1000mg ivgtt qd for 2 weeks, then orally 1000mg bid for 4 weeks.
16118458|NCT02024295|Drug|Polyene Phosphatidyl choline|Polyene Phosphatidyl choline 10ml ivgtt qd for 2 weeks, then Polyene Phosphatidyl choline 456 mg tid orally for 4 weeks.
16118459|NCT02024295|Drug|Ademethionine|after 6 weeks of core treatment stage, then ademethionine 1000mg bid or qd orally for 42 weeks
16118460|NCT02024282|Device|Use of C-reactive protein (CRP) point of care test|
16118461|NCT02024282|Other|Brief intervention and parent leaflet|"Brief interventions are commonly used to give opportunistic advice, discussion, negotiation or encouragement. Mostly they take between 5 to 10 minutes. We developed a brief intervention: we'll ask the clinicians to ask 3 specific questions, namely Are you concerned?, What exactly concerns you? and Why does this concern you?. This intervention is easy to implement in daily practice and no additional training is required.
~We developed a parent information leaflet that gives information about what they can do when their child is ill, which signs are important to follow up and when they really should get advice from a clinician. This could make it easier for them to cope with an ill child. The clinician could use this leaflet to give advice and make clear when they have to re-consult their physician to re-evaluate the child. Our hypothesis is that through creating this safety net, the improper demand for antibiotics could be reduced."
16118462|NCT02024282|Device|Finger Pulse Oximeter|All physicians will be asked to perform a measurement of the oxygen saturation on all children and enter the results on the case report form. The selected device is a clip-on system suitable for use in children, which measures oxygen saturation in the capillary blood as well as the pulse rate.
16118463|NCT02024269|Biological|Adipose Derived Stem Cells|
16118464|NCT02024256|Other|Cold pads soaked in Magnesium sulfate solution|
16118465|NCT02024256|Other|Cold pads soaked in water|
16118466|NCT02024243|Procedure|Punch Tissue Biopsy|Subjects will have two 3 mm punch tissue biopsies of the same wound/ulcer (for OCT & infection) collected on days 0, 14, and 28. Biopsies will not be collected if the wound has closed by day 14 or 28.
16118467|NCT02024230|Drug|Warfarin or Rivaroxaban|No limitations of previous medication (Warfarin or new oral anticoagulant drugs or no anticoagulant drug) and type of stent (bare metal stent or drug eluting stent) in both arms
16118468|NCT02024217|Radiation|S1，oxaliplatin，radiation|Radiation: 180 (cGy) /day, D1-5;S1: 50mg/m2,D1-5;
16118469|NCT02024204|Drug|Fluticasone propionate 230mcg for 3 Months|
16118554|NCT02023554|Drug|Theophylline alone|Drug: Theophylline(100mg,sustained release tablet). Multi-dose of theophylline(100mg,twice daily) will administered at 8 am and 8 pm from day 8 to day 14.
16118470|NCT02024204|Drug|Current Treatment or no treatment|Patients who had symptoms at monitoring visit but are now controlled at V1 will be asked to continue their current treatment (or no treatment) and will continue with the study. They will not be provided with any medications.
16118471|NCT02024204|Drug|Salmeterol 21mcg for 3 Months|
16118472|NCT02024191|Dietary Supplement|Glutamine|
16118473|NCT02024178|Procedure|Ultrasound Imaging|
16118474|NCT02024152|Drug|JDP-205 IV high dose|
16118475|NCT02024152|Drug|JDP-205 IV low dose|
16118476|NCT02024152|Drug|JDP-205 IM|
16118477|NCT02024152|Drug|Control: Zyrtec|
16118478|NCT02024139|Other|Chewing Sugarless Gum|Chewing sugar free gum three times per day for 5-10 minutes
16118479|NCT02024139|Other|Using Mouthwash|Rinse mouth with plax sensitive fluoridated mouthwash for 30 seconds, three times per day
16118480|NCT02024126|Other|Exercise therapy|Exercise therapy
16118481|NCT02024113|Other|Venous blood sample|Collection of a venous blood sample to investigate metabolic changes in blood
16118482|NCT02024087|Drug|Dalantercept plus sorafenib|Subcutaneous (SC) injection of dalantercept once every 3 weeks and oral sorafenib daily.
16118483|NCT02024074|Other|Sestamibi (Tc-MBI) scan of the breast|Patients will be given 8mCi of Sestamibi intravenously. following which Sestamibi scan will be performed on the breast. Sestamibi scan will be done prior to any surgical procedure..
16118484|NCT02024061|Behavioral|Peer support|
16118485|NCT02024061|Behavioral|Regular treatment|The participants in this arm will receive the regular obesity treatment provided by the hospital and university (interactive sessions and physical activity).
16118486|NCT02024048|Other|OCT|Optical coherence tomography in enhanced depth imaging mode
16118487|NCT02024035|Radiation|Radiotherapy|
16118488|NCT02024022|Drug|Standard approach|bowel cleansing with either 4L PEG or sodium picosulphate/magnesium citrate
16118489|NCT02024022|Drug|Individualized approach|
16118490|NCT02024009|Drug|nab-paclitaxel|Abraxane is a proprietary solvent-free, protein-stabilized formulation of paclitaxel comprised of paclitaxel and human albumin in a noncrystalline amorphous state
16118491|NCT02024009|Radiation|60Gy in 30#|
16118492|NCT02024009|Radiation|50.4Gy in 28#|
16118493|NCT02024009|Drug|Nelfinavir|VIRACEPT® (nelfinavir mesylate) is an inhibitor of the human immunodeficiency virus (HIV) protease.
16118494|NCT02024009|Drug|Capecitabine|Given in combination with gemcitabine, known as GemCap.
16118495|NCT02024009|Drug|Gemcitabine|Gemcitabine is indicated for treatment of patients with locally advanced or metastatic adenocarcinoma of the pancreas. It is administered as an infusion
16118496|NCT02023996|Radiation|89Zr-DFO-trastuzumab|
16118497|NCT02023996|Device|PET imaging|
16118498|NCT02023983|Other|Early discharge|Early discharge (within 72 hours) of selected patients with low risk of complications after myocardial infarction with ST segment elevation, treated with successful percutaneous coronary intervention
16118499|NCT02023983|Other|Standard discharge|Discharge after myocardial infarction with ST segment elevation in a standard way accordingly with present practice and physician´s decision (usually 4th-7th day)
16118500|NCT02023970|Device|Patients receiving animal-derived bioprosthetic heart valves.|
16118501|NCT02023970|Other|Echocardiography (1)|
16118502|NCT02023970|Other|Echocardiography (2)|
16118503|NCT02023970|Other|Echocardiography (3)|
16118504|NCT02023970|Biological|Blood sample (1)|
16118505|NCT02023970|Biological|Blood sample (2)|
16118506|NCT02023970|Biological|Blood sample (3)|
16118507|NCT02023957|Behavioral|Interactive computer-assisted screening (iCAS)|
16118508|NCT02023944|Other|Memory and Aging Course|This is a 12-week course that will provide participants with an understanding of what normal and pathological aging processes look like. It will also provide participants with methods to maintain healthy lifestyles as they continue to grow older.
16118509|NCT02023931|Drug|Broccoli Sprout Extract (BSE)|"The first regimen will involve oral delivery and ingestion of 600 μmole doses of glucoraphanin-rich BSE (GRR-BSE), and will represent systemic delivery of sulforaphane to oral mucosa, due to the necessity to metabolize GRR-BSE in the gut.
~The second regimen will involve oral delivery and ingestion of 100 μmole doses of sulforaphane-rich BSE (SFR-BSE), which will represent a combination of systemic and topical delivery to the oral mucosa.
~The third regimen will isolate topical exposure of the oral mucosa to sulforaphane. Participants will swish, hold, then spit 100 μmole doses of SFR-BSE. This regimen (SFR-BSE(T)) will theoretically isolate the pharmacodynamic impact of topical exposure of the oral mucosa to sulforaphane."
16118510|NCT02023918|Drug|pegvisomant|Pegvisomant 20 mg subcutaneously Qday will be administered by the study subject for 28 days during this study.
16118511|NCT02023905|Drug|Everolimus|everolimus at 10 mg daily continuously
16118512|NCT02023905|Drug|Temozolomide|Temozolomide will be dosed initially at 150 mg/m2/day for 5 days out of a 28-day cycle. TMZ will be stopped after 12 cycles
16118513|NCT02023892|Drug|atorvastatin|
16118514|NCT02023892|Drug|placebo|
16118515|NCT02023879|Drug|Alirocumab|Solution for injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre-filled pen).
16118516|NCT02023879|Drug|Placebo (for Alirocumab)|Solution for injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre-filled pen).
16118517|NCT02023879|Drug|Non-statin LMT|Ezetimibe or Fenofibrate at stable dose as background therapy.
16118518|NCT02023879|Other|Diet Alone|Stable cholesterol-lowering diet as background therapy.
16118519|NCT02023866|Drug|Cysteamine Bitartrate|Cysteamine Bitartrate Delayed-release capsules
16118520|NCT02023853|Procedure|ultrasonic|
16118521|NCT02023853|Procedure|erythritol|
16118522|NCT02023853|Drug|metronidazole gel|
16118523|NCT02023840|Drug|metronidazole gel|
16118524|NCT02023840|Procedure|ultrasonics|
16118525|NCT02023840|Procedure|erythritol|
16118526|NCT02023840|Drug|placebo|
16118555|NCT02023541|Radiation|Proton beam therapy|
16118556|NCT02023515|Behavioral|Emotional brain training|Stress management based program
16118557|NCT02023515|Behavioral|Behavioral weight loss|Standard behavioral weight loss
16118527|NCT02023827|Behavioral|RAYS Intervention|The Rise Above Your Situation program (RAYS) is a multimedia computer-tailored intervention that relies on the Transtheoretical Model of Behavior Change (TTM) and expert system technology to deliver assessments, feedback, printed reports, and helpgiver reports with intervention ideas. Helpgivers (probation officers in this case) use the reports to guide 1/2 hour follow-up discussions to reinforce intervention ideas and provide support.
16118528|NCT02023801|Device|Aurora Endometrial Ablation System|Ablation of the endometrial lining of the uterus using the Aurora System
16118529|NCT02023788|Biological|PNEUMOSTEM|"A single intratracheal administration
~Low Dose Group (3 patients): 1.0 x 10^7 cells/kg High Dose Group (6 patients): 2.0 x 10^7 cells/kg
~* The subjects were administered with Pneumostem in the earlier part of the Phase I study. No drug/biologics will be administered to any subject during this part of the study."
16118530|NCT02023775|Device|Melody valve implantation|
16118531|NCT02023749|Dietary Supplement|Nut group|
16118532|NCT02023736|Other|Systemic Therapy Inventory of Change (STIC)|The STIC is a computerized measurement and feedback system for use in psychotherapy. The measurement system consists of weekly questionnaires, completed on the computer, that target symptoms and functioning in a variety of domains of a clients life (e.g., individual symptoms, couple functioning, family functioning, relationship with children). The feedback system consists of a web-portal where therapists may access their clients' STIC responses, for the purposes of planning treatment, assessing progress, and discussing change with clients.
16118533|NCT02023736|Other|Treatment as Usual|Clients receive psychotherapy treatment as planned and implemented by their psychotherapists. Exact type of treatment varies by therapist and according to client need.
16118534|NCT02023723|Dietary Supplement|Energy Drink|16oz energy drinks - 2 consumed within 60 minutes
16118535|NCT02023723|Dietary Supplement|Active Control|16oz control drink: Caffeine 160mg, Sucrose 115g consume 2 - 16oz drinks within 60 minutes
16118536|NCT02023710|Drug|Paclitaxel|175 mg/m^2 by IV infusion on the first day of each 4-week cycle (dose was based on patient's weight and could be adjusted for weight change)
16118537|NCT02023710|Drug|Carboplatin|Dose based on patients' creatinine clearance (Calvert formula) and administered by intravenous (IV) infusion on the first day of each 4-week cycle
16118538|NCT02023710|Drug|Bevacizumab|5mg/kg by intravenous (IV) infusion every two weeks of each 4-week cycle (dose was based on patient's weight at screening and remained the same throughout study)
16118539|NCT02023697|Drug|Radium-223 dichloride (Xofigo, BAY88-8223)|
16118540|NCT02023684|Drug|control saline|Surgical bed irrigation with saline 40ml
16118541|NCT02023684|Drug|Lidocaine|surgical bed Irrigation Lidocaine 0.5%, 40ml
16118542|NCT02023684|Drug|Ropivacaine|surgical bed Irrigation Ropivacaine 0.2%, 40ml
16118543|NCT02023658|Other|pMTCT systems analysis and improvement|Five-step systems analysis and iterative improvement cycles carried out over a six-month period in intervention facilities.
16118544|NCT02023645|Dietary Supplement|active supplement|tablet
16118545|NCT02023645|Other|placebo|tablet
16118546|NCT02023632|Behavioral|Similar-Age-Same-Gender (SASG)|The core feature of the program is that it is exclusively for those of a similar age and same gender. Such an environment was reported to provide opportunities for social connectedness, as well as personal comfort. Secondly, exercise class instructors are volunteers- both providing 'similar-models' to enhance efficacy as well as reduce costs associated with instructors. Consistent with social identity and self-categorization perspectives, the program also makes use of a series of strategies to foster intra-group attraction and group identity. For many of the participants a major draw of the program is that it provides opportunities for the older adults to connect with one another after the classes have ended.
16118547|NCT02023632|Behavioral|Similar-Age-Mixed-Gender (SAMG)|The SAMG physical activity condition will mirror the SASG group condition, but will be open to older adults from both genders. The same strategies to those used within the SASG condition will also be utilized (development of a unique program name, T-shirts, opportunities to socialize after the program), and will be offered three days per week (Mon, Wed, Fri, or Tues, Thurs, Sat). Older adults will also be recruited to be instructors for the group classes (= 65 years), with both males and females invited to occupy these instructional roles. (As with the SASG condition, training will take place between September and December 2013, through the respective YMCA centres. The YMCA will oversee the training of these volunteers through their Fitness Leader Training Program).
16118548|NCT02023632|Behavioral|Mixed-Age-Mixed-Gender (MASG)|The third condition utilized within the RCT is designed to reflect 'standard' group based exercises that one sees in typical physical activity centres. Specifically, these classes are not restricted to participants on the basis of age or gender, and as such older adults will be participating in groups comprised of people younger than themselves as well as those of both gender.
16118549|NCT02023606|Drug|SPN-810M|
16118550|NCT02023593|Drug|FOLFIRI|Patients will receive FOLFIRI every 2 weeks: Irinotecan 180mg/m2 IV over 90 minutes on Day 1; Leucovorin IV over 2 hours on Day 1(l-LV 200 mg/m2 or dl-LV 400 mg/m2 ); 5-Fluorouracil 400 mg/m2 IV bolus on Day 1; followed by 5-Fluorouracil 2.4 g/m2 for 46 hours continuous infusion.
16118551|NCT02023580|Behavioral|Video treatments|"The treatment video vignettes to be delivered between Baseline and 3 Months include: 1) Condom use/anal sex without HIV status disclosure (potentially SDCAS); 2) Condom use/anal sex without HIV status disclosure and perceived responsibility; 3) Discussion of nondisclosure of HIV status prior to sex and perceived responsibility, STIs; 4) Stigma associated with disclosing HIV status to sex partners; 5) HIV/STI testing; and 6) Diagnosis of an STI; STI disclosure to sex partners and perceived responsibility.
~Video boosters to be delivered weekly for 4 weeks between 6 and 9 Months include: 7) HIV status disclosure, condom use, STIs; 8) STI disclosure to sex partners, disclosure to friends, serodiscordant partnerships; 9 & 10) Support of HIV disclosure and perceived responsibility."
16118552|NCT02023567|Drug|SSRIs|fluoxertine hydrochloride 20-60mg/day, paroxetine hydrochloride 20-60mg/day, sertraline hydrochloride 50-200mg/day, citalopram 20-60mg/day, escitalopram 10-20mg/day, fluvoxamine 50-300mg/day
16118553|NCT02023554|Drug|Theophylline with azithromycin|"Drug: Theophylline(100mg,sustained release tablets). Multi-dose of theophylline(100mg,twice daily) will administered at 8 am and 8 pm from day 1 to day 7.
~Drug:Azithromycin(250mg, capsules). Multi-dose of azithromycin(500mg,once daily) will administered at 8 pm from day 1 to day 7."
16118558|NCT02023502|Other|collection of urine and blood sample|
16118629|NCT02022930|Drug|Triamcinolone Acetonide|
16118559|NCT02023489|Device|1H/ 13C and 31P Magnetic Resonance Spectroscopy|Study participants will be studied in the fasting state after an overnight fast of at least 10 h. Participants will arrive at the MR-Centre in the morning of the study. Between 6:30 and 10:00 a.m., 1H MRI (3T) will be performed for the assessment abdominal adipose tissue distribution and composition as well as myocardial functional parameters. 1H/13C MRS examinations (7T) will be performed for measurements of myocardial, skeletal muscle and liver lipid content and composition as well as glycogen content. Additionally, ATP synthesis and energy metabolism will be assessed.
16118560|NCT02023489|Other|Meal Tolerance Test|"A meal tolerance test meal tolerance test according to Petersen et al. (PNAS, Vol 104, 2007) will be performed. After MRI and MRS examinations subjects will be returned at our outpatients clinic, where small polyethylene catheter will be inserted in an antecubital vein for hourly blood sampling. At 10:30 a.m. and 1:30 p.m. two liquid high carbohydrate meals of equal size containing all the required daily energy (30 kcal/kg of body weight; 55% carbohydrate, 10% protein, and 35% fat) with an additional 25% of the daily energy requirements added in the form of sucrose will be served.
~At 5 p.m. subjects will be returned at the MR - Centre for postprandial 1H / 13C MRS (7T) of muscle, liver and myocardial lipid and glycogen contents. Myocardial function parameters and abdominal fat distribution will be assessed again by 1H MRI (3T)."
16118561|NCT02023489|Other|Hyperglycemic-hyperinsulinemic clamp|"All volunteers will be admitted in the morning and basal 13C tracer enrichment will be assessed.
~At 8:00a.m. (0 min) a hyperglycemic-hyperinsulinemic-pancreatic clamp test will be initiated by somatostatin (-5-300 min: 0.1 µg·kg-1·min-1, UCB Pharma, Vienna, Austria) and insulin (0 - 8 min: 80 mU·min-1·m-2 body surface area; 8 -300 min: 40 mU·min-1·m-2 body surface area) infusion. Plasma glucose will be raised and maintained at ~180 mg·dL-1 by primed (0.2 g·kg-1)-variable dextrose infusion (20%w/v) enriched with [1-13C]glucose (40%w/w). A second catheter will be placed into an antecubital vein of the other arm and blood samples for the measurement of glucose, insulin and c-peptide. Glucose concentrations will be analysed immediately every 5 minutes, employing a glucose analyser. Myocardial glycogen concentrations will be measured before the clamp (-60 - 0 min) and from 90 min to 180 min during the clamp employing 13C MRS."
16118562|NCT02023476|Radiation|MRI|MRI- imaging on the upper arm
16118563|NCT02023463|Drug|Enzalutamide|Given PO
16118564|NCT02023463|Drug|Goserelin acetate|Given SC
16118565|NCT02023463|Drug|Leuprolide acetate|Given IM or SC
16118566|NCT02023463|Radiation|Radiation therapy|Undergo image-guided radiation therapy
16118567|NCT02023450|Drug|saquinavir and ritonavir|micro and low dose
16118568|NCT02023450|Drug|saquinavir and ritonavir|standard dose
16118569|NCT02023437|Device|Femtosecond laser cataract surgery|The VICTUS lens fragmentation procedure is part of the femtosecond laser assisted cataract procedure, which generates precise cuts inside the cataractous lens, leading to a softening and fragmentation of the lens.
16118570|NCT02023437|Device|Manual cataract surgery|"Manual: manual group acts as a control group where the lens fragmentation are per-formed manually without femtosecond laser assisted lens fragmentation"
16118571|NCT02023424|Drug|Glatiramer Acetate (Copaxone®)|GA is a potent inducer of Th2-cells and modulates these immune cells to secrete high levels of neurotrophic factors, particularly BDNF. The induced cells cross the blood brain barrier (BBB), accumulate in the CNS and express BDNF and other regulatory substances in situ.
16118572|NCT02023411|Drug|Teriparatide|recombinant human parathyroid hormone (1-34) subcutaneous every day at 8-9 pm
16118573|NCT02023411|Other|Placebo|Placebo
16118574|NCT02023398|Device|BTL-9000 HFT|Deep tissue heating with the BTL-9000 HFT for HFT group
16118575|NCT02023398|Device|sham BTL-9000 HFT|sham deep tissue heating with BTL-9000 HFT in Placebo group
16118576|NCT02023385|Device|BTL-9000 LLLT|Irradiation of adipocyte cells within the fat layer with BTL-9000 LLLT for the release of fat and lipids from these cells
16118577|NCT02023385|Device|sham BTL-9000 LLLT|Irradiation of adipocyte cells within the fat layer with sham BTL-9000 LLLT for the release of fat and lipids from these cells
16118578|NCT02023372|Other|NuCel with Autograft|NuCel is a minimally manipulated allograft product derived from amniotic membrane along with cells from amniotic fluid. Local autograft is bone that comes from the patient's own vertebrae and surrounding bony structures.
16118579|NCT02023359|Drug|Everolimus and exemestane|
16118580|NCT02023346|Behavioral|surveys and cognitive tests|
16118581|NCT02023333|Drug|Regorafenib|All patients that meet the eligibility criteria who have signed informed consent and have enrolled on the trial will be treated with regorafenib, daily 3 weeks on 1 week off for all cycles. Dose will be escalated to 120 mg in week 2 of cycle 1 and all remaining cycles if no excess toxicity is experienced by the patient at the discretion of the treating physician.
16118582|NCT02023320|Dietary Supplement|Low dose of blueberry dry powder|
16118583|NCT02023320|Dietary Supplement|High dose of blueberry dry powder|
16118584|NCT02023307|Device|V-Loc Suture|
16118585|NCT02023294|Procedure|Convetional laparoscopic Sleeve Gastrectomy|Convetional laparoscopic sleeve gastrectomy using 5 ports (incisions) in the abdominal wall
16118586|NCT02023294|Procedure|SILS Sleeve gastrectomy|Single incision Sleeve gastrectomy using only one port (incision) on the abdominal wall assisted by an special Traction Device for single port surgery (Endograb)
16118587|NCT02023281|Behavioral|Exercise|The experimental group will engage in mild-moderate level of exercise. This program will be structured and clinically supervised. Exercise will take place 2-3 days per week for a duration of 30-45 mins. for 12 weeks.
16118588|NCT02023268|Device|T2762|1 drop in each eye 3 to 6 times daily during 84 days
16118589|NCT02023268|Device|Vismed®|1 drop in each eye 3 to 6 times daily during 84 days
16118590|NCT02023255|Drug|JNJ-39393406|In Part A of the study, participants will receive single dose of JNJ-39393406 50 mg, 150 mg, 450 mg, 1,350 mg, and 2,700 mg once daily for 7 consecutive days. In Part B of the study, participants will receive single dose of JNJ-39393406 based on the PK data from Part A of the study once daily for 13 consecutive days.
16118591|NCT02023255|Other|Placebo|In Part A of the study, participants will receive placebo for 7 consecutive days and in Part B of the study, participants will receive placebo for 13 consecutive days.
16118592|NCT02023242|Device|Hydrus Microstent|Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.
16118593|NCT02023242|Device|iStent Trabecular Micro Bypass|Device inserted into Schlemm's canal to enhance aqueous flow from the anterior chamber.
16118596|NCT02023216|Device|Pacifier|The effect of NNS on GER features will be evaluated in preterm infants suffering from GER symptoms, for which a 24-hour pH-MII monitoring has been scheduled. During the monitoring period each infant will receive 8 meals: 4 meals will be followed by NNS, applied by pacifier, while the other 4 not. The sequence of NNS application will be consecutively alternated in study participants. At least 2 hours of NNS are required for the validity of each post-prandial evaluation; measures to fix the pacifier will be strictly forbidden. In the subgroup of babies with recurrent desaturations a simultaneous non-invasive 6-hour PSG monitoring comprehensive of 2 meals (one followed by NNS, the other not), will be performed to evaluate the effect of NNS on apneas, bradycardias and hypoxic episodes.
16118597|NCT02023203|Procedure|Totally Extraperitoneal laparoscopic inguinal hernia repair|Laparoscopic hernioplasty
16118598|NCT02023164|Drug|JDP-205 Injection|
16118599|NCT02023164|Drug|Diphenhydramine|
16118600|NCT02023151|Drug|Omalizumab|
16118601|NCT02023138|Other|Focus group|Two hours focus group to allow the participants to modify a clinical practice guideline recommendation
16118602|NCT02023138|Other|Wiki|A specially tailored interactive communication website (Wiki) to allow the participants to modify a clinical practice guideline recommendation
16118603|NCT02023125|Drug|Alectinib|A single 600-mg oral dose of alectinib will be administered in a fasted or fed condition.
16118604|NCT02023125|Drug|Esomeprazole|Esomeprazole 40 mg will be administered orally once daily for 6 days prior to alectinib administration.
16118605|NCT02023125|Other|High Fat and Calorie Meal|High fat and calorie meal served prior to alectinib administration
16118606|NCT02023125|Other|Standard Meal|Standard meal served prior to alectinib administration
16118607|NCT02023112|Drug|ABT-450/r/ABT-267|Tablet; ABT-450 coformulated with ritonavir and ABT-267
16118608|NCT02023112|Drug|Ribavirin|Capsule
16118609|NCT02023099|Drug|ABT-450/r/ABT-267|Tablet; ABT-450 coformulated with ritonavir and ABT-267
16118610|NCT02023099|Drug|Placebo|Tablet
16118611|NCT02023086|Procedure|Contrast sensitivity measurement|Contrast sensitivity test is made with targets alternating black and white lines. The larger the lines are, easier it is to see them. Targets are distributed in 5 rows, each oriented at a different angle. Contrast sensitivity level is determined by the smallest target seen by the participant, line by line. This test is done under dim lightning with the habitual visual correction worn.
16118612|NCT02023086|Procedure|Slit Lamp assessment and intra-ocular pressure measurement|Slit lamp is used to assess the presence of significant lens opacities known as Fabry cataracts. In fact, these opacities can induced a bias on the contrast sensitivity measurement and can increase the symptoms felt by the patient. A grade 2 (CFDI grading chart) of lens opacities is considered clinically significant and this will become an exclusion criteria for the following of the study. Intra-ocular pressure will be measured with a non contact tonometer (air pulsed) (Ocular Response Analyser, Reichert Instrumentation.)
16118613|NCT02023086|Procedure|Visual field testing|"Visual field will be assessed with an automated perimeter (Humphrey, Texas) using a threshold strategy. This implies that the subject has to identify not only if he perceives the visual stimulus but the minimal level of this stimulus (in decibels), to be seen, is also recorded. Visual field will be tested up to 30 degrees from the central point of fixation.
~In order to measure immediate variability of the visual testing among Fabry subjects, this test will be done at the beginning of the testing session (in the morning) and another time 1h00 later."
16118614|NCT02023086|Procedure|Oxygen flow at the optic nerve head measurement|"Pupils will be dilated with 1 drop of 1% tropicamide. The procedure is similar to the one used for taking a photo of the retina. Each measurement session represents a continuous recording of 20 simultaneous functions of reflectometry from the optic nerve area during 10 seconds.
~During all recording sessions, the systemic arterial oxygen saturation will be also monitored at the right index finger using a pulse oximeter (Escort M10, Invivo, Orlando, USA). Arterial blood pressure will be also monitored before and after the testing using a manual sphygmomanometer."
16118615|NCT02023086|Drug|Tropicamide|Used to dilate patient's pupil during testing
16118616|NCT02023086|Device|OSOME|The OSOME system is the only technology able to perform on line and real time capillaries blood oxygenation measurement in the eye. The system operates with 1200 discreet wavelengths between 400 nm to 700 nm with 500 millisecond integration times. It is not invasive, functioning just like a fundus camera.
16118617|NCT02023047|Drug|Nifedipine 12 mg coated suppositories|
16118618|NCT02023034|Other|Virtual exercises|The exercises will be performed with the Nintendo ® Wii Balance Board ® platform, and consist in: 1) Table Tilt; 2) Obstacle Course; 3) Tilt City; 4) Basic step; 5) Penguin; 6) Heading Soccer; 7) Basic Run. All patients underwent 12 sessions, twice a week for a period of 06 weeks.
16118619|NCT02023021|Drug|nab-paclitaxel|Patients firstly receive nab-paclitaxel 100 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.
16118620|NCT02023021|Drug|gemcitabine|Patients secondly receive gemcitabine 1000 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.
16118621|NCT02023008|Procedure|yoga therapy|Undergo integral yoga intervention with videoconferencing
16118622|NCT02023008|Other|internet-based intervention|Undergo integral yoga intervention with videoconferencing
16118623|NCT02023008|Other|questionnaire administration|Ancillary studies
16118624|NCT02022982|Drug|Palbociclib|Palbociclib will be administered orally once daily, 3 weeks out of every 4 in each cycle. The initial dose for phase 1 of the study will be 75 mg daily. Dosing will be adjusted until Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) are established. No pre-medications for palbociclib are required. It should be administered without food with patients fasting for 1 hour prior and 2 hours post drug administration.
16118625|NCT02022982|Drug|PD-0325901|PD-0325901 will be administered orally twice daily, 3 weeks out of every 4 in each cycle. The initial dose for phase 1 of the study will be 2 mg twice daily. Dosing will be adjusted until Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) are established. PD-0325901 will be administered using a flat-dosing plan. No premedications are required. As the effect of food on PD-0325901 is uncertain, patients will be permitted to dose either fasting or after food.
16118626|NCT02022956|Drug|Lorcaserin|
16118627|NCT02022930|Device|Hydros|
16118630|NCT02022917|Drug|Bevacizumab|Bevacizumab 15 mg/ Kg (from post-op cycle 2) intravenous infusion for 30 minutes in a 21 days' cycle for at least three cycles (best to 6 cycles) followed by 3-weekly maintenance bevacizumab 15 mg/ Kg intravenous infusion for 17 cycles.
16118631|NCT02022904|Device|Near infrared (NIR) emissive nanotechnology|
16118632|NCT02022891|Behavioral|systematic psychological care|Prevention treatment plan that provides systematic medical and psychological care at routine pediatric consultations for SCD. Bio-psychosocial paradigm applied at pediatric consultations.
16118633|NCT02022878|Procedure|PCI of CTO|
16118634|NCT02022852|Drug|Capecitabine|50Gy, 2Gy/day per time, 5 days a week, for 5 weeks+capecitabine 850mg/m2 bid on the day accept radiotherapy. Rest for 8 weeks and surgery followed.
16118635|NCT02022852|Drug|XELOX|XELOX 2 cycles (oxaliplatin 130mg/m2 ivgtt 2-6h day 1,capecitabine 1000 mg/m2 bid day 1-14 repeat every 3 weeks) → 50Gy, 2Gy/day per time, 5 days a week, for 5 weeks+capecitabine 850mg/m2 bid on the day accept radiotherapy → XELOX 1 cycle. Rest for 2 weeks and surgery followed.
16118636|NCT02022826|Device|SmartPill Monitoring System|
16118637|NCT02022813|Dietary Supplement|Supplemental parenteral nutrition (SPN)|The amount of energy delivered by SPN will depend on the indirect calorimetry measurement and actual enteral feed delivery. SPN will be reduced with progressing EN
16118638|NCT02022800|Other|PET 18FDOPA|contribution of PET 18FDOPAimagery in high level glioma diagnosis
16118639|NCT02022787|Other|patients with renal cell carcinoma|Chemokines that may be elevated in patients with RCC
16118640|NCT02022774|Drug|Fimasartan|Fimasartan 60 ~ 120 mg/po take one tablet once a day
16118641|NCT02022761|Drug|Laninamivir octanoate|40 mg dose consists of 2 laninamivir octanoate TwinCaps® DPI 80 mg dose consists of 4 laninamivir octanoate TwinCaps® DPI (2 administered 12 hours apart)
16118642|NCT02022748|Drug|ticagrelor|Group A is hemodialysis subjects. Crossover design will be implemented for Group A subjects. Group A will be randomized into 2 sequences, Sequence 1 and Sequence 2. In Sequence 1, subjects will receive treatment A in Period 1 and treatment B in Period 2. Washout period of at least 7 days between Period 1 and Period 2 in Sequence 1. Treatment A and Treatment B are defined as follows: Treatment A subjects will be dosed with oral 90 mg ticagrelor tablet 1 day following the dialysis session but 2 days before the next dialysis session. Treatment B will be dosed with oral 90 mg ticagrelor tablet just prior to dialysis session.
16118643|NCT02022748|Drug|ticagrelor|Group A is hemodialysis subjects. Crossover design will be implemented for Group A subjects. Group A will be randomized into 2 sequences, Sequence 1 and Sequence 2. In Sequence 2, subjects will receive treatment B in Period 1 and treatment A in Period 2. Washout period of at least 7 days between Period 1 and Period 2 in Sequence 2. Treatment A and Treatment B are defined as follows: Treatment A subjects will be dosed with oral 90 mg ticagrelor tablet 1 day following the dialysis session but 2 days before the next dialysis session. Treatment B will be dosed with oral 90 mg ticagrelor tablet just prior to dialysis session.
16118644|NCT02022748|Drug|ticagrelor|Group B is healthy subjects. Group B healthy subjects will receive oral 90 mg ticagrelor referred to as Treatment H.
16118645|NCT02022735|Device|Deep Brain Stimulator|DBS will provide brain stimulation.
16118646|NCT02022722|Drug|Trigger Point Injections Triamcinolone Acetonide, Bupivacaine Hydrochloride|The mixture is injected into the levator muscles, with half the volume on each side of the pelvic musculature.
16118647|NCT02022722|Procedure|Pelvic Rehabilitation|Pelvic floor massage will be performed on a weekly basis by a licensed physiotherapist specialized in pelvic floor pelvic therapy
16118648|NCT02022709|Drug|Fluoxetine|The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.
16118649|NCT02022709|Drug|Sertraline|The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.
16118650|NCT02022709|Drug|Paroxetine|The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.
16118651|NCT02022709|Drug|Citalopram|The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.
16118652|NCT02022709|Drug|Fluvoxamine|The dosage depends on clinician's judgement ,but not over the maximum tolerated dosage.
16118653|NCT02022709|Behavioral|Exposure and Response Prevention|8 exposure and response prevention (ERP) sessions,once a week
16118654|NCT02022696|Genetic|Lentiviral Gene Transfer|
16118655|NCT02022683|Device|ELVR (Endoscopic Lung Volume Reduction) with Zephyr Valves|
16118656|NCT02022670|Drug|Placebo|Sugar pill manufactured to mimic sodium nitrite capsules
16118657|NCT02022670|Drug|Sodium Nitrite|80 mg/d or 160 mg/d
16118658|NCT02022657|Drug|Truvada|Truvada is a combination pill consisting of tenofovir and emtricitabine used in PrEP
16118660|NCT02022631|Other|Alternative summary of findings table format|Investigators will compare one SoF table with alternative formats (Table A) against one SoF table with the current formats (Table B). In both tables, the clinical question in terms of patients and setting, intervention, comparator, and outcomes informed by the tables, and the complementary information included as footnotes will be the same. The only differences between the current and alternative SoF table formats will be different methods to either show the same data in a different way or to provide complementary data to the one showed in the current format (i.e. supplementary data as risk difference).
16118661|NCT02022631|Other|Current summary of findings table format|Investigators will compare one SoF table with alternative formats (Table A) against one SoF table with the current formats (Table B). In both tables, the clinical question in terms of patients and setting, intervention, comparator, and outcomes informed by the tables, and the complementary information included as footnotes will be the same. The only differences between the current and alternative SoF table formats will be different methods to either show the same data in a different way or to provide complementary data to the one showed in the current format (i.e. supplementary data as risk difference).
16118662|NCT02022605|Device|Hands-on EMS training|A trainer (SAH) gave a series of demonstrations of the proper techniques of ERCP step by step on the EMS. The demonstration included selective cannulation, sphincterotomy, guidewire exchange, balloon dilation, stone extraction and stent insertion. Then trainees practiced each technique with hands-on coaching from the trainer on the EMS. Each trainee could repeate the practice with the trainer giving only verbal correction of any errors for about 30min.
16118771|NCT02021656|Drug|LDV/SOF|90/400 mg FDC tablet administered orally once daily without regard to food
16118663|NCT02022605|Other|Standard training|The standard cannulation technique was used with a sphincterotome preloaded with a guidewire, positioned in the ampullary orifice, and targeting the presumed entry of CBD or PD. During the whole procedure of cannulation by trainees, the senior endoscopist would actively communicate with trainees through verbal and/or hands-on assistance to help them to make the performance more correctly. If the trainees failed to enter the targeted duct within 10min, the senior endoscopist would take over the duodenoscope and continue the following procedure of cannulation.
16118664|NCT02022592|Drug|Lormetazepam|
16118665|NCT02022592|Drug|Midazolam|
16118666|NCT02022579|Procedure|DCE-MRI and DWI|DCE-MRI defined lesion(s) compared with biopsy results or 1-year follow up
16118667|NCT02022566|Behavioral|A supported self management of osteoarthritis program|Three theoretical sessions, each of about 90 minutes, held as group sessions with about 10 participants in each group. After the intervention patients are offered an individual exercise program, and the opportunity to practice this program together with others under supervision of a physical therapist for 6 weeks.
16118668|NCT02022553|Procedure|usual rectal cancer surgery|
16118669|NCT02022553|Procedure|RACHEL|
16118670|NCT02022540|Drug|PAN-90806 Ophthalmic Solution|
16118671|NCT02022540|Drug|Lucentis|
16118672|NCT02022527|Drug|Acetyl Salicylic Acid|
16118673|NCT02022527|Drug|Warfarin|
16118674|NCT02022527|Drug|Placebo (for Aspirin)|Sugar pill manufactured to mimic 75 mg Aspirin
16118675|NCT02022514|Other|Mononuclear cells from autologous bone marrow|Mononuclear bone marrow cells autologous intracoronary
16118676|NCT02022514|Drug|Conventional medical treatment|
16118677|NCT02022501|Drug|DE-120|
16118678|NCT02022488|Drug|midazolam|Group M
16118679|NCT02022488|Drug|alfentanil|Group MA
16118680|NCT02022488|Drug|ketamine|Group MK
16118681|NCT02022475|Drug|Vitamin D|100 000 units oral vitamin D as 2 capsules 50 000 units each
16118682|NCT02022475|Other|placebo|2 placebo capsules will be applied as a single dose
16118683|NCT02022462|Behavioral|Health Navigation|"Experimental: Immediate peer health navigator intervention vs. waitlist control.
~The immediate peer health navigator intervention group will receive assistance for 6 months and then followed up with after an additional 6 months. Participants will receive training in how to self-manage their physical health and healthcare. The intervention is individualized and the number of contacts by the navigator will be determined by their need level. The waitlist control group will complete a baseline assessment and then wait for 6 months before receiving the peer health navigator intervention. They will complete a follow-up assessment after 6 months of the intervention."
16118684|NCT02022449|Behavioral|Stress management|Cognitive behavioral stress management Cognitive and emotionally focused coping enhancement strategies Progressive muscle relaxation Social support Strategies for parenting a child with cancer
16118685|NCT02022436|Drug|contrast ultrasound|Definity® is the contrast agent that will be administered by intravenous injection by a registered nurse during the ultrasound (contrast enhanced ultrasound (CUS). The purpose is to assist in identifying differences in AAA characteristics based on gender and AAA stability and growth.
16118686|NCT02022423|Behavioral|Telephone counseling|4 months of weekly contact to update exercise prescription and discuss barriers and challenges to adherence
16118687|NCT02022423|Behavioral|Internet-based walking program|Four-month Internet-based walking program consisting of weekly step count goals
16118688|NCT02022410|Other|CAS after primary and revision TKA|CAS and RAPT
16118689|NCT02022384|Other|Blood sample and life quality questionnaires|Blood will be drawn at distinct time points during and after radio(chemo)therapy
16118690|NCT02022371|Procedure|Targeted biopsies of the prostate|Multiple biopsies from a MRI lesion for analysis of intratumour heterogeneity
16118691|NCT02022358|Drug|Glucarpidase|Glucarpidase rescue (50 units/kg x 1, intravenously)
16118692|NCT02022358|Drug|Methotrexate|Methotrexate (12 g/m2 x 1, intravenously)
16118693|NCT02022358|Drug|Folinic Acid|Folinic acid rescue 15mg/m2 four times daily adjusted according to methotrexate levels
16118694|NCT02022345|Procedure|Percutaneous Coronary Intervention|
16118695|NCT02022319|Device|Ultrasonographic Shear Wave Elastography|
16118696|NCT02022306|Drug|TD-6450|
16118697|NCT02022306|Drug|Placebo|
16118698|NCT02022293|Drug|Atorvastatin|Patients in this group will take 20mg per night.
16118699|NCT02022293|Other|Placebo|
16118700|NCT02022280|Drug|Lansoprazole|
16118701|NCT02022254|Drug|semaglutide|Subjects will initiate treatment with 0.25 mg for the first four weeks followed by dose doubling every four weeks up to a dose of 1.0 mg.
16118702|NCT02022254|Drug|placebo|Semaglutide placebo will be administered s.c.
16118703|NCT02022254|Drug|metformin|For oral administration twice daily, in two periods, each of 3.5 days duration. The first period is initiated before semaglutide treatment and the second period is initiated at the end of semaglutide treatment.
16118704|NCT02022254|Drug|warfarin|For oral administration, given as a single dose. The first dose is given before semaglutide treatment and the second dose is given at the end of semaglutide treatment.
16118705|NCT02022241|Drug|triptorelin|0.2 mg, ih, at night and 0.2 mg, ih, 12 hours later when at least one of the following criteria was reached: (i) serum E2 ≥3500 pg/ml, (ii) ≥18 follicles measuring ≥11 mm.
16118706|NCT02022228|Drug|triptorelin|0.2 mg triptorelin, ih
16118707|NCT02022228|Drug|hCG|1000 IU hCG, im
16118708|NCT02022228|Drug|hCG|500IU hCG, im
16118709|NCT02022215|Drug|ME1111 Solution, Low strength|ME1111 Solution, Low strength, applied once daily for 48 weeks
16118710|NCT02022215|Drug|ME1111 Solution, High strength|ME1111 Solution, High strength, applied once daily for 48 weeks
16118711|NCT02022215|Drug|Matching Vehicle Solution|Matching Vehicle Solution, applied once daily for 48 weeks
16118712|NCT02022189|Procedure|Renal Biopsy|
16118713|NCT02022176|Other|Glucose Uptake|Glucose uptake is measured by oral glucose tolerance test and euglycemic clamp
16118714|NCT02022176|Other|Resting metabolic rate|Resting metabolic rate is measured by indirect calorimetry after an over-night fast
16118715|NCT02022176|Other|Nitrite infusion|Sodium nitrite or saline was infused at escalating doses at a rate of 1, 10 or 100 nmol kg-1 min-1 (10 minutes per dose) in a randomized, double blinded cross-over fashion
16118716|NCT02022163|Biological|Low dose of H7 VLP vaccine + Alhydrogel|Low dose of H7 VLP vaccine mixed with Alhydrogel, 2 doses given 21 days apart
16118717|NCT02022163|Biological|Med dose of H7 VLP vaccine + Alhydrogel|Med dose of H7 VLP vaccine mixed with Alhydrogel, 2 doses given 21 days apart
16118718|NCT02022163|Biological|High dose of H7 VLP vaccine + Alhydrogel|High dose of H7 VLP vaccine mixed with Alhydrogel, 2 doses given 21 days apart
16118719|NCT02022163|Biological|High dose of H7 VLP vaccine|High dose of H7 VLP vaccine, 2 doses given 21 days apart
16118720|NCT02022163|Biological|Placebo|Placebo, 2 doses given 21 days apart
16118721|NCT02022150|Behavioral|Body composition in paracentesis|Takin blood samples and bioelectrical impedance measurmeent, Neuropsychological tests evaluation
16118722|NCT02022137|Dietary Supplement|Red cereal bar|Consumption of the cereal bar with agave fructans or lactitol or lactose added each bar with 10 grams of dietary fiber and 1.2 grams of protein by weight and 20 to 30 grams of fiber.
16118723|NCT02022137|Dietary Supplement|Green cereal bar|Consumption of the cereal bar with agave fructans or lactitol or lactose added each bar with 10 grams of dietary fiber and 1.2 grams of protein by weight and 20 to 30 grams of fiber.
16118724|NCT02022137|Dietary Supplement|White cereal bar|Consumption of the cereal bar with agave fructans or lactitol or lactose added each bar with 10 grams of dietary fiber and 1.2 grams of protein by weight and 20 to 30 grams of fiber.
16118725|NCT02022124|Drug|Microcrystalline cellulose (open-label inert substance)|The intervention will be an inert substance, microcrystalline cellulose in a capsule. Participants will take two capsules daily.
16118726|NCT02022111|Behavioral|Patient Education and Behavioral Activation|To stimulate and motivate sustained, effective self-care, patient education materials and behavioral activation techniques that are adapted for the Indian population will be used by care coordinators. Behavioral activation strategies are brief, structured psychological interventions that are based on extensive theoretical and clinical literature, can be delivered by non-specialist providers, can be combined with antidepressant medications, and emphasize reinforcing behaviors to produce improvements in thoughts, mood, and quality of life.
16118727|NCT02022111|Behavioral|Supporting Self-Care (care coordinators)|Care coordinators will: (a) meet with intervention arm patients and collaboratively set treatment goals; (b) provide verbal education regarding diabetes and depression self-care ;(c) will use motivational interviewing and self-efficacy enhancement strategies to promote monitoring of depressive symptoms, glucose, BP; (d) will proactively follow-up to externally monitor depression symptoms and CVD indicators; (e) will enter updated patient indicators into decision-support electronic health record and utilize software outputs to prioritize patients for review; (g) will convene case review meetings with supervising physicians; and (h) will communicate physician-recommended treatment changes to patients and their routine providers.
16118728|NCT02022111|Other|Psychiatrist and Diabetologist Reviews|Senior psychiatrist and endocrinologist/diabetologist will be involved in weekly offline case review meetings with care coordinators. Case review meetings will be structured: the decision-support electronic health record will help prioritize cases that are new (within 3 weeks of randomization); have moderate/severe depression symptoms (based on Patient Health Questionnaire (PHQ)-9) ≥6 weeks after most recent treatment changes, or continued poor HbA1c, home glucose, BP, or LDL-c control in past 4 weeks; or have not been reviewed for 3 months. Based on patient indicators and current therapies, physicians will recommend treatment changes (initiation, increases, or simplification of medication regimens) which will be communicated by care coordinators to patients and their usual care providers.
16118729|NCT02022111|Other|Decision-support Electronic Health Record System|The decision-support electronic health record will store patient indicators entered by the Nurse Case Managers (NCM) and provide diabetes and depression care prompts based on an evidence-based treatment algorithm developed from recommended guidelines for control of diabetes and depression, Indian formularies, and TeamCare investigators. The decision-supported electronic health record (DS-EHR) will prioritize patients (new; poorly-controlled; or well-controlled but not reviewed ≥3 months) for case review meetings and promote accountability (physicians must justify rejecting electronic care prompts).
16118730|NCT02022111|Other|Standard of Care|Participants randomized to the control arm will receive the existing standard care and treatment for their diabetes that is provided routinely at each Clinic Site and their care provider will be notified regarding their depressive symptoms. The physicians treating the control arm will also be provided with trainings regarding identification and care for people with depression. The control participants will have no contact with care coordinators and will only be contacted at 6-monthly intervals for assessment by the blinded outcomes assessor.
16118735|NCT02022085|Device|Baha Attract System|The Cochlear Baha Attract System incorporates both implantable and external parts. The implantable parts include the BI300 Implant and the BIM400 Implant Magnet, which is intended to be fixated to the BI300 Implant. The external parts include the Sound Processor Magnet (SP Magnet), which, together with the Implant Magnet, constitute the transcutaneous coupling. The SP Magnet incorporates a soft material (Soft pad) at the tissue facing surface that is designed to distribute the pressure over the skin. The Baha Sound Processor attaches to the SP Magnet via a snap coupling.
16118736|NCT02022072|Device|measures of assisted vital capacity by a mechanical insufflation/exsufflation (Cough Assist®)|measures of assisted vital capacity by a mechanical insufflation/exsufflation (Cough Assist®)
16118737|NCT02022059|Drug|Lidocaine = group A|Patient requiring a SNG for nutrition entérale benefiting from a pre-medication by spray of lidocaïne during the insertion (group A = lidocaine)
16118738|NCT02022059|Drug|Group B placebo|Patient requiring a SNG for nutrition entérale benefiting from a pre-medication by placebo during the insertion
16118739|NCT02022046|Other|Methylation biosignature|Methylation biosignature, CKD staging, assessment of cardiovascular function, and traditional/uremia-related risk factors will be performed.
16118772|NCT02021643|Drug|Sofosbuvir|Sofosbuvir 400 mg tablet administered orally once daily
16118802|NCT02021422|Drug|fluorouracil|fluorouracil 2400 mg/m2 48 hours
16118848|NCT02021058|Other|Experimental Formula|Experimental formula
16118740|NCT02022033|Drug|FOLFOXA|"Abraxane: 150mg/m2 IV over 30 minutes, day 1 (administered first) every 14 days.
~Oxaliplatin: 85mg/m2, IV over 2 hours, day 1 every 14 days Leucovorin: 400mg/m2, IV over 2 hours, day 1 every 14 days 5-FU infusion:1200mg/m2/day, as a continuous IV infusion over 2 days, day 1 and day 2 (for a total dose of 2400mg/m2 over 46 hours.)"
16118741|NCT02022007|Drug|Metformin XR|"Start 2 pills (2 pills of 500 mg =1000mg XR) for 3 weeks
~Increase to 4 pills as tolerated (4 pills of 500 mg XR =2000 mg XR) for remainder of study"
16118742|NCT02022007|Drug|Saxagliptin|"Start 1 pill (5 mg)) for 3 weeks
~Remain at 1 pill (5mg dose) for remainder of study"
16118743|NCT02022007|Drug|Saxagliptin-Metformin XR|"Start 1 pill (2.5 mg/ 1000mg XR) for 3 weeks
~Increase to 2 pills as tolerated (5mg/2000 mg XR) for remainder of study"
16118744|NCT02021968|Biological|TetraVax-DV-TV003|TetraVax-DV-TV003 is a live attenuated recombinant tetravalent dengue virus vaccine, which will be administered as a 0.5 mL dose containing 10^3.0 plaque forming units (PFUs) each of DENV-1, DENV-2, DENV-3, and DENV-4. It will be delivered by subcutaneous injection in the deltoid region of the upper arm.
16118745|NCT02021968|Biological|rDEN2∆30-7169|The challenge virus, rDEN2∆30-7169, is a live recombinant attenuated DENV-2 candidate vaccine virus and will be administered as a 0.5 mL dose containing 10^3 PFUs of rDEN2∆30-7169. It will be delivered by subcutaneous injection in the deltoid region of the upper arm.
16118746|NCT02021968|Biological|Placebo|The placebo vaccine is the vaccine diluent 1X L-15, which will be administered as a 0.5 mL dose delivered by subcutaneous injection in the deltoid region of the upper arm.
16118747|NCT02021955|Behavioral|guideline treatment recommendations|Primary care clinicians receive guideline concordant treatment recommendations for their patients discharged from hospital for a COPD exacerbation.
16118748|NCT02021942|Drug|SOM230 LAR|SOM230 LAR in a dosage of 60 mg is administered i.m. once every 4 weeks.
16118749|NCT02021929|Drug|Sorafenib|"Sorafenib is a kinase inhibitor indicated for the treatment of:
~Unresectable hepatocellular carcinoma
~Advanced renal cell carcinoma
~Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment"
16118750|NCT02021929|Drug|Placebo|
16118751|NCT02021903|Other|V1: HGPO + meal and V2: placebo + meal|"Ambulatory polysomnography for the night preceding each test
~Usual antiparkinsonian treatments at their usual dose and timing
~Randomisation to receive an oral solution of glucose load or a placebo (fructose). Standard meal 4 hours after the test
~During two hours following the oral solution administration and the standardized meal, we will perform the followings for each patient :
~continuous digital blood pressure monitoring by Nexfin®
~blood pressure monitoring at brachial artery
~continuous polysomnographic recording
~synchronized continuous digital audiovisual recording
~glucose and insulin blood level monitoring Additional blood samples will be taken in order to assay the intestine-pancreatic neuropeptides including incretins GLP- 1 and GIP"
16118752|NCT02021903|Other|V1: placebo 75mg + meal and V2: HGPO 75mg + meal|"Ambulatory polysomnography for the night preceding each test
~Usual antiparkinsonian treatments at their usual dose and timing
~Randomisation to receive an oral solution of glucose load or a placebo (fructose). Standard meal 4 hours after the test
~During two hours following the oral solution administration and the standardized meal, we will perform the followings for each patient :
~continuous digital blood pressure monitoring by Nexfin®
~blood pressure monitoring at brachial artery
~continuous polysomnographic recording
~synchronized continuous digital audiovisual recording
~glucose and insulin blood level monitoring Additional blood samples will be taken in order to assay the intestine-pancreatic neuropeptides including incretins GLP- 1 and GIP"
16118753|NCT02021890|Behavioral|Dance program|two-hour dancing session twice a week, led by instructors in a private hall of a disco. Both solo and partner and group dances were performed during each session: an initial one-hour activity, chaired by two instructors who taught new steps and choreographies to patients (both individually and in group), was followed by a second hour, when patients danced in pairs both Latin and standard ballroom music
16118754|NCT02021890|Behavioral|Self-selected physical activity|gym sessions (with the support of sports associations), exercising at home (cycling, stepping) or walking, jogging or cycling outside with/without group support
16118755|NCT02021864|Drug|vitamin D3 50,000 unit|vitamin D3 50,000 unit/week for 8 weeks
16118756|NCT02021864|Drug|prenatal multivitamin|daily prenatal multivitamin containing elemental calcium 250 mg/day and vitamin D3 400 unit
16118757|NCT02021851|Drug|Dexamethasone and aprepitant|
16118758|NCT02021851|Drug|Dexamethasone and ondansetron|
16118759|NCT02021838|Other|Lethality Assessment Program|Law enforcement officers conduct risk screen of domestic violence victims, if high risk victims are referred to domestic violence services.
16118760|NCT02021838|Other|Domestic Violence High Risk Team|Law enforcement officers conduct risk screen of domestic violence victims, if high risk victims are referred to domestic violence services and a team who monitors the clinical and criminal justice progress.
16118761|NCT02021825|Drug|Mitoxantrone|The treatment protocol consisted of 12 mg/m2 MITO intravenous infusions every 3 months for 2 years. Dosage was adjusted according to side effects.
16118762|NCT02021812|Device|Branched TAG® Device|
16118763|NCT02021799|Dietary Supplement|Moringa and Lactobacillus rhamnosus GR-1|
16118764|NCT02021786|Behavioral|Mobile phone based intervention|Parents in the intervention group receive a six month mHealth program (the MINISTOP app) based on social cognitive theory with strategies to change unhealthy diet and physical activity behaviors. The program includes information, advice, and strategies to change unhealty behaviours and the possibility to register the child's intake of fruits, vegetables, candy, sweetened beverages, moderate-to-vigorous physical activity, and sedentary time. Feedback is then provided on reported variables. In addition, the parents are able to ask questions through the app to a dietician and a psychologist.
16118765|NCT02021773|Drug|LBR-101 High Dose|Subcutaneously Administered LBR-101 Monthly x 3
16118766|NCT02021773|Drug|LBR-101 Low Dose|Subcutaneously Administered LBR-101 Monthly x 3
16118767|NCT02021773|Drug|Placebo|Subcutaneously Administered Placebo (Vehicle) Monthly x 3
16118768|NCT02021760|Procedure|Primary Percutaneous Coronary Intervention|Primary Percutanous Coronary Intervention is performed in both Groups.
16118769|NCT02021669|Drug|Omega-3 supplement|Two grams of the EPA form of omega-3 daily and 50 mgs of sertraline daily for 10 weeks
16118770|NCT02021669|Drug|Placebo|Two grams of corn oil plus 50 mg of sertraline daily for 10 weeks.
16118801|NCT02021422|Drug|Irinotecan|Irinotecan 180 mg/m2 90 minutes
16118773|NCT02021643|Drug|RBV|Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
16118774|NCT02021643|Drug|PEG|Pegylated interferon alfa-2a (Peg-IFNα-2a) 180 µg/0.5 mL pre-filled syringe administered subcutaneously once a week
16118775|NCT02021630|Other|Outcomes|No intervention will occur during this study. Evaluation of changes in patients' family after having patient has bariatric surgery.
16118776|NCT02021617|Device|Intraosseous access|The EZ-IO Intraosseous Vascular Access System (Vidacare Corporation, Shavano Park, TX, USA) has been cleared by the U.S. Food and Drug Administration, Health Canada, and the European Union for the administration of drugs and fluids anytime vascular access is difficult to obtain in emergent, urgent, or medically necessary cases. It consists of a driver-a small battery-powered drill-and a needle set designed for insertion into the IO space of the proximal tibia, distal tibia, or proximal humerus. Needles are 15 gauge and available in three lengths: 15 mm, 25 mm, and 45 mm. In this study the 45 mm EZ-IO needle set will be used for all humeral placements and the 25 mm needle set will be used for all tibial placements.
16118777|NCT02021604|Drug|Fluorodopa F 18|A dose of Fluorodopa F 18, 3-6 MBq/Kg (0.08-0.16 mCi/kg), will be injected intravenously into the subject under the direct supervision of the radiology sub-investigator. Then, the PET imaging procedure will begin and proceed for up to 70 minutes after injection. An abdominal CT image will be made using intravenous contrast. Both images, PET and CT, will be co-localized by the radiologist for interpretation.
16118778|NCT02021591|Behavioral|Mobile Diabetes Detective (MoDD)|MoDD is a web-based application that is designed to help individuals with diabetes identify specific problems related to glycemic control, and engage in problem-solving process. MoDD includes a number of messages that explain its users the nature of various problems related to glycemic control, aspects of individuals' behaviors that might have contributed to these problems, and alternative behaviors that could help to improve glycemic control. In addition to these messages displayed on the MoDD website, study participants may receive SMS messages with reminders to test blood glucose, or to follow the selected new behavior.
16118779|NCT02021578|Behavioral|Family Cognitive Behavioral Prevention|Parent training and cognitive behavioral intervention with parents. Coping skills training with children.
16118780|NCT02021578|Behavioral|Written information|Reading materials about depression
16118781|NCT02021565|Behavioral|Immediate Intervention Group|Assistive Technology (AT) Specialists, experts on assistive technology devices and how to performing transfer tasks, train Veteran and caregiver dyads to safely, skillfully, and (when appropriate) independently perform three activities of daily living (ADLs): transferring in and out of bed, toileting, and bathing. During the baseline assessments, AT Specialists also recommend assistive technology equipment (grab bars, bed rails, raised toilet seats, etc.), environmental modifications, adaptive methods, and energy conservation techniques. On the first day of the intervention, AT Specialists provide and install recommended equipment and train the dyad to complete the three ADLs using the recommended the modified methods.
16118782|NCT02021565|Other|Delayed Intervention Control Group|Receives the in-home training intervention six weeks after completing the initial baseline assessment. This allows for a control comparison group while still providing the intervention to all participants.
16118783|NCT02021552|Other|blood sampling|5 ml blood sampling
16118784|NCT02021539|Procedure|Cervical ultrasound +elastography 1|Included patients will have a cervical ultrasound upon arrival in the maternity ward. This latter exam will include elastographic measurements, and will be followed by a vaginal fibronectin measurement. Patients will then be treated via a tocolytic (anti-contraction treatment), and two hours later a second cervial ultrasound including elastographic measures will be performed.
16118785|NCT02021539|Biological|Vaginal fibronectin measurement|Included patients will have a cervical ultrasound upon arrival in the maternity ward. This latter exam will include elastographic measurements, and will be followed by a vaginal fibronectin measurement. Patients will then be treated via a tocolytic (anti-contraction treatment), and two hours later a second cervial ultrasound including elastographic measures will be performed.
16118786|NCT02021539|Drug|Tocolytic treatment for 2 hours|Included patients will have a cervical ultrasound upon arrival in the maternity ward. This latter exam will include elastographic measurements, and will be followed by a vaginal fibronectin measurement. Patients will then be treated via a tocolytic (anti-contraction treatment), and two hours later a second cervial ultrasound including elastographic measures will be performed.
16118787|NCT02021539|Procedure|Cervical ultrasound +elastography 2|Included patients will have a cervical ultrasound upon arrival in the maternity ward. This latter exam will include elastographic measurements, and will be followed by a vaginal fibronectin measurement. Patients will then be treated via a tocolytic (anti-contraction treatment), and two hours later a second cervial ultrasound including elastographic measures will be performed.
16118788|NCT02021526|Drug|Triheptanoin|Triheptanoin (C7 oil) is a 7-carbon medium chain triglyceride.
16118789|NCT02021513|Dietary Supplement|Fish Oil|Fish Oil (2.25gm EPA and 2.25gm DHA total)
16118790|NCT02021513|Dietary Supplement|Olive Oil|Placebo group
16118791|NCT02021500|Drug|ABI-007|No intervention is being given in this extension study which is gathering survival information on participants of study NCT 00844649 (Celgene study CA046) who were known to be alive as of March 2013)
16118792|NCT02021474|Drug|Histamine Dihydrochloride|
16118793|NCT02021474|Drug|Subcutaneous placebo (Evan's solution = phenol 0.4%, isotonic sodium chloride).|
16118794|NCT02021461|Drug|ESL Banana taste|oral suspension with Banana flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
16118795|NCT02021461|Drug|ESL Grape taste|oral suspension with Grape flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
16118796|NCT02021461|Drug|ESL Tutti-Frutti taste|oral suspension with Tutti-Frutti flavor at a concentration of 50 mg/mL and was administered in 2.5 mL doses.
16118797|NCT02021448|Other|Annual visits among 3 years. During each visit different testings are performed in order to detect an obesity-hypoventilation syndrome (OHS)|Polygraphy/Polysomnography,Blood sampling, EKG,Lung function testing,Arterial blood gases,Thoracic radiography,Six-minute walk test,Respiratory questionnaires
16118798|NCT02021435|Dietary Supplement|salt substitute|Free salt substitute provided
16118799|NCT02021422|Drug|anakinra|Dosage Route Administration 100 mg SC Every Other Day
16118800|NCT02021422|Drug|Oxaliplatin|Oxaliplatin 85 mg/m2 2-4 hours
16118803|NCT02021409|Drug|BAY85-3934|Oral doses of BAY 85-3934 will be available in multiples of 5, 25, and 75 mg tablets
16118804|NCT02021409|Biological|Darbepoetin alfa|
16118805|NCT02021396|Procedure|Embolization|this arm of the study was interventional (splenic artery embolization)
16118806|NCT02021383|Behavioral|Bi-weekly in person meetings with a Registered Dietician|"Participants in the Contest Plus group had the opportunity to receive 5 in person meetings with a Registered Dietician. These meetings took place bi-weekly and gave the participants a chance to discuss food consumption, physical activity, meal planning and assessed the participant's weight at each visit.
~Participants in the Contest only and Control group were not eligible to receive these meetings."
16118807|NCT02021383|Behavioral|Financial incentives for weight loss maintenance|Participants in the Contest Plus and Contest Only groups were eligible for a lottery based financial incentive for maintaining their weight lost during phase 1 (Baseline to week 10) of the trial. There were three, month-long follow up assessments (weeks 16, 20 and 24) that participants were eligible for. The lottery prize was contingent upon the length of time they maintained their weight loss.
16118808|NCT02021370|Drug|BAY85-3934|25mg Tablet
16118809|NCT02021370|Drug|Placebo|Matching placebo tablet
16118810|NCT02021357|Behavioral|hyperboloid associated with the exercise of proprioceptive|
16118811|NCT02021357|Other|hyperboloid|
16118812|NCT02021344|Behavioral|Mental Health First Aid|Originally developed in 2001, MHFA is a 12-hour course comprised of six modules, covering depression, anxiety, psychosis, substance abuse, eating disorders, and self-harm. Each module includes information about the mental health-related problems (e.g., signs and symptoms), advice on how to respond appropriately, and interactive activities to enhance the learning process. Some modules include videos with perspectives of individuals recovering from mental disorders and examples of how to effectively use the MHFA intervention. Program participants learn how to help individuals in crisis and also how to recognize early warning signs and intervene before mental health problems progress to crises.
16118813|NCT02021331|Device|immediate implant placement without provisionalization|
16118814|NCT02021331|Device|immediate implant placement with immediate provisionalization|
16118815|NCT02021318|Drug|Roxadustat|Oral tablet.
16118816|NCT02021318|Drug|Darbepoetin alfa|Subcutaneous or intravenous injection.
16118817|NCT02021292|Drug|Macitentan|Macitentan 10 mg, oral tablet, to be taken once daily.
16118818|NCT02021292|Drug|Placebo|Matching placebo oral tablet, to be taken once daily.
16118819|NCT02021279|Device|MatriStem Pelvic Floor Matrix|
16118820|NCT02021279|Procedure|native tissue repair|
16118821|NCT02021266|Biological|Enriched Hematopoetic Stem Cell Infusion|Enriched Hematopoetic Stem Cell Infusion
16118822|NCT02021253|Dietary Supplement|Probiotic|Lactibiane TOLERANCE vs Placebo
16118823|NCT02021253|Dietary Supplement|Placebo|
16118824|NCT02021240|Drug|Ketamine|
16118825|NCT02021240|Drug|Dexamethasone|
16118826|NCT02021240|Drug|Normal Saline|
16118827|NCT02021227|Procedure|Early chair sitting exercise|A chair sitting exercise will be done at least once a day and for > 1 hour
16118828|NCT02021214|Drug|Methylphenidate|
16118829|NCT02021214|Drug|Placebo|
16118830|NCT02021201|Drug|risperidone|Patients with schizophrenia will be treated for 10 weeks treatment with risperidone
16118831|NCT02021201|Drug|Sertindole|Patients with schizophrenia will be treated for 10 weeks treatment with serindole
16118832|NCT02021175|Behavioral|Tailored CBME Therapy via Technology|6 Sessions of tailored interactive Cognitive-Behavioral Motivational Enhancement Therapy delivered through internet and cell phones
16118833|NCT02021175|Other|Standard of Care|Referral to currently available resources for 6 sessions of a standard smoking cessation approach
16118834|NCT02021149|Device|High intensity whole-body infrared heating|The Whole Body Hyperthermia system uses water-filtered infrared-A (wIRA) heat radiation. The rise in the body's core temperature is correspondingly rapid and well-tolerated. There are two phases of the thermal challenge, 1) Irradiation phase during which the patient lies recumbent with his/her head positioned outside the tent. The wIRA irradiators are arranged above the exposed upper part of the body; and 2) Heat retention phase during which the patient lies in the chamber with the walls of the tent positioned to retain heat. Core body temperatures will be raised to those comparable to a mild fever 37.8-38.5°C.
16118835|NCT02021149|Behavioral|Psychotherapy|Weekly psychotherapy using cognitive behavioral therapy sessions with a therapist.
16118836|NCT02021149|Other|Questionnaires|Weekly questionnaires to assess changes in mood, perceptions of self and perceptions of effectiveness of the therapist/patient bond will be administered.
16118837|NCT02021149|Device|Low intensity whole-body infrared heating|Attenuated heating using only heating coils at the bottom of the Heckel device. This results in only a minor increase in skin temperature and no increase in core body temperature. The participant will still feel heat and will see similar lighting and hear similar sounds as those occurring during actual WBH, and will be in the chamber for the same period of time.
16118838|NCT02021136|Device|Rebel Reliever|Rebel Reliever knee brace + usual antalgic treatment + physical exercises recommendations
16118839|NCT02021136|Other|Control|Usual antalgic treatment + physical exercises recommendations
16118840|NCT02021123|Drug|Anidulafungin 100mg single dose iv|Anidulafungin 100mg single dose iv pre-surgery (gastric bypass)
16118841|NCT02021110|Drug|Ursodeoxycholic Acid|The intervention group will receive 15-20mg/kg/day UDCA for 24 weeks
16118842|NCT02021097|Drug|Levonorgestrel 100 mcg and Ethinyl Estradiol 20 mcg|Tablet, orally, opd
16118843|NCT02021097|Drug|Levonorgestrel 150 mcg and Ethinyl Estradiol 30 mcg|Tablet, orally, opd
16118844|NCT02021084|Dietary Supplement|probiotic|Probiotics group - patients will received probiotics Bio -25 including 11 types of bacteria total of 25 billion germs in each capsule, patients will received one capsule a day for 3 month.
16118845|NCT02021084|Dietary Supplement|Placebo|Placebo group - patients will received placebo patients will received one capsule a day for 3 month.
16118846|NCT02021071|Radiation|XperGuide|Live 3D image needle guidance which overlays live fluoroscopy and 3D soft tissue imaging data from previous acquired CT, MR or XperCT.
16118847|NCT02021071|Radiation|XperGuide with virtual path planning|Instrument guidance allowing certain tasks that would normally occur using continuous X-ray guidance to be performed with reduced dose for patient and staff.
16118849|NCT02021058|Other|Standard control formula|Standard Infant formula
16118850|NCT02021045|Device|Renal hemodialysis (Fresenius 2008K, Bad Homburg, Germany)|Renal replacement therapy is frequently used in patients with renal failure in order to eliminate substances obligatory excreted by the urine.
16118851|NCT02021032|Device|Prolieve|Prolieve® is a transurethral microwave therapy device equipped with automated controls designed to deliver microwave energy to the prostate and balloon-administered compression for the treatment of symptomatic BPH. This device utilizes a transurethral catheter with microwave antenna to heat the prostate, with simultaneous 46 Fr. prostatic urethral catheter balloon-administered compression.
16118852|NCT02021019|Procedure|Renal Denervation|Renal Denervation
16118853|NCT02021006|Drug|nitrofurantoin|"antibiotic prophylaxis of urinary tract infections The antibiotic for prophylaxis will be chosen by Physicians according to the local resistance spectrum of bacteria responsible of UTIs
~Physicians can chose one the following schedules:
~nitrofurantoin 1.5-2 mg/kg per day
~amoxicilline/clavulanic acid 15 mg/kg per day (dose expressed in units equivalent to amoxicilline)
~cefixime 2 mg/kg per day
~trimethoprim/sulfamethoxazole 2.5 mg/kg per day (dose expressed in units equivalent to trimethoprim)"
16118854|NCT02021006|Other|No prophylaxis|children will be followed, but no antibiotic prophylaxis will be administered
16118855|NCT02021006|Drug|Amoxicillin-Potassium Clavulanate Combination|"antibiotic prophylaxis of urinary tract infections The antibiotic for prophylaxis will be chosen by Physicians according to the local resistance spectrum of bacteria responsible of UTIs
~Physicians can chose one the following schedules:
~nitrofurantoin 1.5-2 mg/kg per day
~amoxicilline/clavulanic acid 15 mg/kg per day (dose expressed in units equivalent to amoxicilline)
~cefixime 2 mg/kg per day
~trimethoprim/sulfamethoxazole 2.5 mg/kg per day (dose expressed in units equivalent to trimethoprim)"
16118856|NCT02021006|Drug|Trimethoprim/sulfamethoxazole|"antibiotic prophylaxis of urinary tract infections The antibiotic for prophylaxis will be chosen by Physicians according to the local resistance spectrum of bacteria responsible of UTIs
~Physicians can chose one the following schedules:
~nitrofurantoin 1.5-2 mg/kg per day
~amoxicilline/clavulanic acid 15 mg/kg per day (dose expressed in units equivalent to amoxicilline)
~cefixime 2 mg/kg per day
~trimethoprim/sulfamethoxazole 2.5 mg/kg per day (dose expressed in units equivalent to trimethoprim)"
16118857|NCT02021006|Drug|Cefixime|"antibiotic prophylaxis of urinary tract infections The antibiotic for prophylaxis will be chosen by Physicians according to the local resistance spectrum of bacteria responsible of UTIs
~Physicians can chose one the following schedules:
~nitrofurantoin 1.5-2 mg/kg per day
~amoxicilline/clavulanic acid 15 mg/kg per day (dose expressed in units equivalent to amoxicilline)
~cefixime 2 mg/kg per day
~trimethoprim/sulfamethoxazole 2.5 mg/kg per day (dose expressed in units equivalent to trimethoprim)"
16118858|NCT02020980|Biological|Botulinum toxin type A|"This is an observational study designed to reflect the clinical practice in real life as closely as possible.
~Botulinum Toxin Type A (BoNT-A) injection administered according to the local Summary of Product Characteristics (SmPC) and the locally agreed treatment guidelines."
16118859|NCT02020967|Other|Non-interventional cross-sectional survey|This is a survey which does not involve any intervention into routine clinical practice, including the use of any investigational therapy or special examination methods.
16118860|NCT02020954|Procedure|ECG, echocardiography, cardiac MRI, sera biomarkers|
16118861|NCT02020941|Drug|carfilzomib|Given IV
16118862|NCT02020941|Drug|dexamethasone|Given IV or PO
16118863|NCT02020941|Other|laboratory biomarker analysis|Correlative studies
16118864|NCT02020928|Device|Low level laser therapy|Low level laser therapy: Laser Therapy XT (DMC) having red light with a wave length of 660 nm (± 10 nm) and infrared light with a wavelength of 808 nm (± 10 nm) is used, both power of 100 mW (± 20%), applied in a timely manner.
16118865|NCT02020915|Procedure|lateral sphincterotomy|
16118866|NCT02020915|Procedure|ultrasound guided lateral sphincterotomy|
16118867|NCT02020902|Other|Cetrizine hydrochloride|As provided on the patient information leaflet
16118868|NCT02020889|Biological|Mepolizumab|Mepolizumab will be provided as a lyophilized cake in sterile vials for individual use to be reconstituted with sterile water for Injection, just prior to use.
16118869|NCT02020889|Drug|Placebo|Placebo will be available as 0.9% sodium chloride
16118870|NCT02020876|Other|DECIPHER Questionnaire|Participants are asked to complete a questionnaire to assess the impact of Decipher on physicians' treatment recommendation. All participants use the same data collection instrument. Each participant opinion is collected based on a random selection of cases.
16118871|NCT02020863|Device|Closed Loop|Fluid management in the closed loop group will be performed via a closed loop (automated) system that will use an infusion pump (Q-Core) and a controller (a computer run index and algorithm developed by Sironis) to make frequent, regular and accurate adjustments to the amount of fluid the patient receives using feedback from standard operating room monitors.
16118872|NCT02020837|Procedure|Lymphaticovenous Micro-Anastomosis|
16118873|NCT02020824|Behavioral|Exposure to anxiogenous environments|"The anxiogenous environments are defined by several levels of possible anxiety classified progressively and independently by each patient at the beginning of the study. The exposure is applied during the 8 sessions for each of the arms Exposure to anxiogenous environments (with or without control)."
16118874|NCT02020824|Other|Imagery with functional MRI initial|Subjects will be submitted to 1 session of fMRI during their first visit, in order to identify and evaluate the activation of cerebral fields involved during the exposure to anxiogenous environments.
16118875|NCT02020824|Other|Imagery with PET-scanner initial|Subjects will be submitted to 1 session of PET-scanner during their first visit, in order to measure the synaptic activity during the exposure to anxiogenous environments.
16118876|NCT02020824|Other|Imagery with functional MRI final|Patients will be submitted to 1 session of fMRI during a follow-up visit, in order to identify and evaluate the activation of cerebral fields involved during the exposure to anxiogenous environments.
16118877|NCT02020824|Other|Imagery with PET-scanner final|Patients will be submitted to 1 session of PET-scanner during a follow-up visit, in order to measure the synaptic activity during the exposure to anxiogenous environments.
16118878|NCT02020811|Device|Sentinel|
16118879|NCT02020798|Other|Dietary Intervention|
16118975|NCT02020070|Procedure|Radical Prostatectomy|
16119051|NCT02019472|Biological|sirukumab 100 mg|SC injections
16119052|NCT02019472|Biological|sirukumab 50 mg|SC injections
16118880|NCT02020785|Other|Higher phosphorus period|"Commercially-available unaltered food/beverage products containing phosphorus additives (~1gm/d of phosphorus) will be given for 3 weeks.
~All participants at the beginning of the study will receive dietary education to reduce their baseline consumption of phosphorus to a goal of ~1gm/d by receiving education on avoiding phosphorus-based additives."
16118881|NCT02020785|Other|Lower phosphorus period|"Commercially-available unaltered food/beverage products without phosphorus additives (<10mg/d of phosphorus) will be given for 3 weeks.
~All participants at the beginning of the study will receive dietary education to reduce their baseline consumption of phosphorus to a goal of ~1gm/d by receiving education on avoiding phosphorus-based additives."
16118884|NCT02020759|Device|Transcranial Doppler Ultrasound|Transcranial Doppler Ultrasound is used to monitor cerebral microembolism
16118885|NCT02020746|Drug|EscharEx|
16118886|NCT02020746|Drug|Gel Vehicle|
16118887|NCT02020733|Device|Balloon catheter|
16118888|NCT02020733|Device|metal cannula|
16118889|NCT02020720|Procedure|Biopsy|Undergo image-guided biopsy
16118890|NCT02020720|Procedure|Computed Tomography|Undergo 18F-DOPA-PET/CT
16118891|NCT02020720|Procedure|Diffusion Weighted Imaging|Undergo DTI
16118892|NCT02020720|Drug|Fluorine F 18 Fluorodopa|Undergo 18F-DOPA-PET/CT
16118893|NCT02020720|Other|Laboratory Biomarker Analysis|Correlative studies
16118894|NCT02020720|Procedure|Perfusion Magnetic Resonance Imaging|Undergo pMRI
16118895|NCT02020720|Procedure|Positron Emission Tomography|Undergo 18F-DOPA-PET/CT
16118896|NCT02020720|Procedure|Therapeutic Conventional Surgery|Undergo stereotactic craniotomy
16118901|NCT02020694|Drug|Vitamin D|
16118902|NCT02020694|Drug|Placebo (for vitamin D)|
16118903|NCT02020681|Device|Curodont Repair|Self-assembling peptide, biomimetic re-mineralisation
16118904|NCT02020681|Other|Placebo|Formulation of Curodont Repair without the peptide P11-4
16118905|NCT02020681|Device|Fluoride|Single application on day D90
16118906|NCT02020668|Other|Physiotherapy|
16118907|NCT02020668|Other|Wait list control|
16118908|NCT02020655|Other|Shear- force model|Shear- force model
16118909|NCT02020642|Procedure|Renal transplantation|Renal transplantation from cadaveric or live donor
16118910|NCT02020629|Drug|Lixisenatide|Lixisenatide is given for 6 weeks whereafter a hypoglycemia clamp is undertaken
16118911|NCT02020616|Drug|LY3053102|Administered SC
16118912|NCT02020616|Drug|Exenatide ER|Administered SC
16118913|NCT02020616|Drug|Placebo|Administered SC
16118914|NCT02020616|Drug|Metformin|Administered orally (PO)
16118915|NCT02020603|Device|epinephrine injection plus soft coagulation using hemostatic forceps|
16118916|NCT02020603|Device|epinephrine injection plus argon plasma coagulation|
16118917|NCT02020590|Drug|ALLOB® implantation|Each patient will undergo a single administration of ALLOB® into the delayed-union site under anesthesia.
16118918|NCT02020577|Drug|Cetuximab( erbitux®)|once per week
16118919|NCT02020577|Drug|Afatinib|once per day
16118920|NCT02020564|Behavioral|Speed of Processing Training|
16118921|NCT02020564|Behavioral|Placebo Control|
16118922|NCT02020551|Drug|Lidocaine Spray|
16118923|NCT02020551|Drug|Placebo|
16118924|NCT02020538|Other|Low-chloride perioperative intravenous fluid strategy|The low-chloride perioperative IV fluid strategy will include the use of PlasmaLyte 148 or Hartmann's solution as the crystalloid of choice and 20% albumin as the colloid of choice.
16118925|NCT02020538|Other|High-chloride perioperative intravenous fluid strategy|
16118926|NCT02020525|Procedure|restrictive transfusion strategy|Patients allocated to the restrictive transfusion strategy were transfused only when their hemoglobin concentration decreased below 7.7 g d dL-1 and were then maintained at hemoglobin concentrations between 7.7 and 9.9 g d dL-1.
16118927|NCT02020525|Procedure|liberal transfusion strategy|Patients assigned to the liberal strategy were transfused when their hemoglobin concentration fell below 9.9 g dL-1, aiming at maintaining hemoglobin at or above 10 g dL-1.
16118928|NCT02020512|Drug|0.03% Bimatoprost|0.03% bimatoprost (LUMIGAN®) 1 drop in the affected eye once daily in the evening as monotherapy or adjunctive therapy for 5 weeks.
16118929|NCT02020499|Drug|Somatuline Autogel® (lanreotide) 60, 90, 120 mg.|Patients receiving treatment as prescribed by the investigator and according to current treatment recommendations and routine clinical practice, and in line with local regulations.
16118930|NCT02020486|Drug|Perampanel|2 mg up to 4 mg
16118931|NCT02020486|Drug|Perampanel|2 mg up to 6 mg
16118932|NCT02020460|Device|Subdural trial lead|
16118933|NCT02020460|Device|Epidural trial lead|
16118934|NCT02020434|Drug|RPX7009 and RPX2014|The study is designed to enroll approximately 32 subjects. There will be approximately 24 subjects with varying degrees of renal insufficiency and approximately 8 subjects with normal renal function.
16119047|NCT02019498|Other|ususal care|Participants allocated to the usual care waiting list group will continue with their usual care without receiving any additional therapy
16118939|NCT02020408|Drug|[11C]raclopride|1.[11C]raclopride -The change (Δ) in BPND (the difference between the [11C]raclopride BPND at baseline and post-AMPH treatment normalized to the baseline BPND
16118940|NCT02020408|Drug|[11C]DASB|BPND of [11C]DASB.
16118941|NCT02020408|Drug|amphetamine|The change (Δ) in BPND (the difference between the [11C]raclopride BPND at baseline and post-AMPH treatment normalized to the baseline BPND.
16118942|NCT02020395|Dietary Supplement|test meal (500 kcal)|whole wheat bread (68 g), butter(10 g), ham (25 g); chocolate cream (90 g); orange juice (200 mL)
16118943|NCT02020395|Dietary Supplement|test meal (500 kcal)|whole wheat bread (68 g), butter(10 g), ham (25 g); chocolate cream (90 g); orange juice (200 mL)
16118944|NCT02020382|Device|qPCR diagnostic KIT of microRNAS|testing qPCR diagnostic KIT of microRNAS from colonic biopsies
16118945|NCT02020369|Biological|Coagulation Factor VIIa (Recombinant)|A cross over design to assess the efficacy of 2 separate dose regimens (75µg/kg and 225 µg/kg) of Coagulation Factor VIIa (Recombinant) for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to Factor VIII/IX
16118946|NCT02020356|Behavioral|Music therapy|"U sequence: the musical sequence lasts 20 minutes and is made up of several phases that progressively induce a relaxed state in the patient. The phase of maximum relaxation is followed by a stimulating phase."
16118947|NCT02020356|Behavioral|Placebo|Interview with an occupational activity (such as discussion of personal pictures or news) with the caregiver in charge of music therapy sessions with the same period.
16118948|NCT02020343|Behavioral|taste tests|"Subjects undergo sham feeding in which they take a bit of food, chew it and spit it out. This test should engage sensory mechanisms which may affect intestinal signaling."
16118949|NCT02020330|Drug|Artemether-lumefantrine 3 days|One tablet contains 20mg artemether and 120mg lumefantrine. The standard regimen is twice daily for 3 days with a delay of at least 8 hours between the first and second dose. It is dosed by weight categories. One gram of fish oil will be given to half of the participants in the 3 days arm.
16118950|NCT02020330|Drug|Artemether-lumefantrine 5 days|One tablet contains 20mg artemether and 120mg lumefantrine. The experiment regimen is twice daily for 5 days with a delay of at least 8 hours between the first and second dose. It is dosed by weight categories. One gram of fish oil will be given to half of the participants in the 5 days arm.
16118951|NCT02020317|Behavioral|decision support in potassium-inc. drug-drug-interactions|display of computer-based reminders for serum potassium monitoring and hyperkalemia alerts
16118952|NCT02020304|Drug|combined spinal epidural|Combined Spinal Epidural
16118953|NCT02020291|Drug|Foxy-5|
16118954|NCT02020278|Drug|Tolvaptan|"Tolvaptan 3.75-, 7.5-, 15-, and 30-mg spray-dried tablets. Dosage: Depending on age and weight, Tablet (3.75 mg - 60 mg daily). Frequency: Once daily.
~Duration: Participants may be eligible to receive short-term or long-term optional tolvaptan treatment at any time during their participation in the trial, with one or more treatment cycles over a 6-month period."
16118955|NCT02020265|Device|EEG neurofeedback|
16118956|NCT02020252|Behavioral|Testing an interactive technology in a diverse health literary population|Enrollment in therapeutic cancer trials remains low, and is especially challenging for patients with low health literacy. We tested an interactive technology designed for patients with diverse health literacy skills aimed at improving patient receptiveness, willingness, knowledge, self-efficacy and positive attitudes regarding clinical trials.
16118957|NCT02020239|Other|Exercise|
16118958|NCT02020226|Drug|TH-302|480 mg/m2 30 min IV infusion on Days 1, 8, and 15 of a 28 day cycle
16118959|NCT02020213|Drug|Posaconazole|400 mg po bid for 8 weeks
16118960|NCT02020200|Drug|MPH|MPH dosage will be determined according to participants' body weight: dosage: 10 mg in case weight<40 kg; 30 mg in case weight>90 kg; otherwise 20 mg.
16118961|NCT02020200|Drug|Placebo|
16118962|NCT02020187|Other|Exercise on a cycle-ergometer|Home training on an ergometer-cycle 30 minutes every other day or at least three times a week. Subject will exercise in a pulse interval corresponding to 70% of their maximal VO2.
16118963|NCT02020161|Drug|Atra|
16118964|NCT02020161|Drug|Idarubicin|
16118965|NCT02020161|Drug|methotrexate|
16118966|NCT02020135|Drug|PSMA ADC|Upon recommendation from the PI and after Sponsor approval, a subject benefiting from treatment could have received up to eight additional doses Q3W. Subjects were weighed prior to each cycle and dosing was calculated on a mg/kg basis prior to each dose, with a maximum weight of 100 kg for dosing calculations.
16118967|NCT02020122|Drug|Duloxetine|duloxetine 60mg
16118968|NCT02020122|Drug|Pregabalin|pregabalin 150mg
16118969|NCT02020122|Drug|Placebo|non active placebo
16118970|NCT02020109|Radiation|splenic irradiation|
16118971|NCT02020096|Procedure|Ultrasound and nerve stimulator guided lumbar plexus block|An insulated nerve block needle connected to a nerve stimulator that was delivering a current of 1.5 mA at a frequency of 2 Hz was then inserted in the long axis (in- plane) of the ultrasound transducer towards the the hypoechoic psoas compartment. If the quadriceps contraction which produces patella twitching was elicited with an initial current of 1.5mA,then the current should be reduced until contraction is still present between 0.3 to 0.5 mA .Afterward, the lumbar plexus nerve block was performed by using 30mL of 0.5% ropivacaine. Contraction should stop below a current of 0.3mA, otherwise intraneural needle position should be suspected.
16118972|NCT02020096|Procedure|Nerve stimulator guided lumbar plexus block|The block was conducted following traditional Winnie approach. The accepted end point for the lumbar plexus is stimulation of the femoral nerve component, observed by contraction of the quadriceps muscle. Quadriceps contraction which produces patella twitching should be sought with an initial current of 1.5mA, and once elicited the current should be reduced until contraction is still present between 0.3 to 0.5 mA. Afterward, the lumbar plexus nerve block was performed by using 30mL of 0.5% ropivacaine. Contraction should stop below a current of 0.3mA, otherwise intraneural needle position should be suspected.
16118973|NCT02020070|Drug|Degarelix|
16118974|NCT02020070|Drug|Ipilimumab|
16118976|NCT02020057|Procedure|Total knee arthroplasty|Total knee arthroplasty with standard incision and approach, and cement fixation. Zimmer Nexgen posterior stabilized total knee implants are used.
16118977|NCT02020044|Other|Endothelial Keratoplasty|
16118978|NCT02020031|Drug|Vancomycin|
16118979|NCT02020018|Device|Prevena Incision Management System|negative pressure therapy that will be applied instead of the regular dressing immediately postoperatively in high risk patients and kept for 6-7 days
16118980|NCT02020018|Other|Conventional sterile dry wound dressing|regular dressing that is applied immediately postoperatively for high risk patients in the operating room after sternotomy
16118981|NCT02020005|Other|Non-flavored 2mg nicotine gum|
16118982|NCT02020005|Other|Non-flavored 4mg nicotine gum|
16118983|NCT02020005|Other|Mint-flavored 2mg nicotine gum|
16118984|NCT02020005|Other|Mint-flavored 4mg nicotine gum|
16118985|NCT02020005|Other|Non-flavored nicotine inhaler|
16118986|NCT02020005|Other|Mint-flavored nicotine ihaler|
16118987|NCT02019979|Drug|metformin|Addition of metformin 1000 mg po bid to standard of care platinum based chemotherapy
16118988|NCT02019979|Behavioral|carbohydrate restricted diet|addition of dietary counseling and metformin 1000 mg po bid to platinum based chemotherapy
16118989|NCT02019953|Other|Yoga|The yoga intervention, which is taught based on Hatha yoga, will be offered to study participants in Study Arms 1, 2, and 3, is a combination of asanas (poses), pranayams (breathing exercises), and meditation. Blood pressure and heart rate measurements are taken before and after each session.
16118990|NCT02019953|Other|Walking|The walking intervention, which is Study Arm 4 includes, three guided walking sessions per week for 24 weeks. Each class is an hour in length and will include a minimum of 30 minutes of walking at the equivalent of a minimum of three miles per hour. Each session includes a ten-minute warm-up and ten-minute cool-down period of some stretches and walking at a leisurely pace. Blood pressure and heart rate measurements are taken before and after each session.
16118991|NCT02019953|Other|Healthy Lifestyles Education|Participants randomly assigned to the fifth study arm attend one 60-minute healthy lifestyles class per week for 24 weeks. The Healthy Lifestyles curriculum includes 24 independent lesson modules, which allows participants to begin their intervention at any time during the course schedule. Blood pressure and heart rate measurements are taken before and after each session.
16118992|NCT02019940|Drug|Riluzole|
16118993|NCT02019927|Device|Transcorneal Electrical Stimulation|The clinical trial will investigate whether Transcorneal Electrical Stimulation delivered by the Okuvision Stimulation Set manufactured by Okuvision GmbH, Reutlingen, Germany, is a potentially effective therapy for the restoration and rehabilitation of vision loss as measured by improvements in visual acuity in the following three patient populations: patients with ocular trauma, patients with optic neuritis associated with multiple sclerosis and patients with Non-arteritic Anterior Ischemic Optic Neuropathy.
16118994|NCT02019927|Device|Sham|Sham
16118995|NCT02019901|Other|Nurse-led clinic|
16118996|NCT02019875|Drug|Rifampin|P450 inducer
16118997|NCT02019875|Drug|Clarithromycin|CYP3A4 and Pgp inhibitor in both intestine and liiver
16118998|NCT02019875|Other|Grapefruit Juice|CYP3A4 inhibitor in intestine
16118999|NCT02019875|Other|Placebo|
16119000|NCT02019862|Device|TRJ® Total Hip Arthroplasty|
16119001|NCT02019849|Device|Plasmafit® Total Hip Arthroplasty|
16119002|NCT02019836|Other|Determining maternal and neonatal vitamin D levels|
16119003|NCT02019823|Behavioral|Informational SMS-text|
16119004|NCT02019823|Behavioral|Interactive SMS-text|
16119005|NCT02019823|Behavioral|Enhanced usual care|
16119006|NCT02019810|Drug|Norepinephrine|
16119007|NCT02019810|Drug|Dobutamine and norepinephrine|
16119008|NCT02019797|Drug|Desflurane|Patients are assigned to desflurane group (Des) or propofol group (Prop). Des receives desflurane (1-2 MAC) inhalation between the induction of anesthesia and before cardiopulmonary bypass (CPB). After the induction of CPB, the anesthesia in Des is switched to a total intravenous anesthesia (TIVA) with propofol. Prop receives a propofol during the surgery.
16119009|NCT02019784|Drug|Rifaximin-α|Rifaximin-α will be compared to placebo with the various outcome measures assessed at baseline (pre-randomisation), and then at 30 days and 90 days.
16119010|NCT02019784|Drug|Placebo Oral Tablet|Placebo Oral Tablet
16119011|NCT02019758|Drug|Oral Viscous Budesonide|Oral Viscous Budesonide - 1 mg/4 mL, 4 mL of slurry twice daily
16119012|NCT02019758|Drug|Fluticasone MDI|Fluticasone multi-dose inhaler - 4 puffs twice daily (880 mcg, twice daily)
16119013|NCT02019758|Drug|Placebo slurry|Slurry of sucralose - 4 mL twice daily
16119014|NCT02019758|Drug|Placebo inhaler|Placebo inhaler - 4 puffs twice daily
16119015|NCT02019745|Biological|LAIV|Standard dose of LAIV administered by a licensed health care providers.
16119016|NCT02019732|Other|Data collection|Data collection from existing electronic healthcare databases (Marketscan Commercial database, MarketScan Medicare Supplemental database).
16119017|NCT02019719|Drug|GSK1278863|GSK1278863 will be supplied as film coated tablets for oral administration containing 1 mg, 2 mg, or 5 mg of GSK1278863.
16119018|NCT02019719|Drug|Placebo|Film coated tablets of GSK1278863 matching placebo for oral administration.
16119019|NCT02019706|Radiation|DOTATATE PET-CT|68Ga-DOTATATE
16119020|NCT02019706|Radiation|F-DOPA PET CT|18F-DOPA PET CT
16119021|NCT02019706|Diagnostic Test|CT scan|routine CT scan
16119022|NCT02019706|Diagnostic Test|MRI|Routine MRI and gated MRI gadolimium
16119023|NCT02019693|Drug|INC280|Supplied by Novartis as film-coated tablet for oral use.
16119024|NCT02019667|Drug|SGS-742|
16119025|NCT02019667|Drug|Placebo|
16119026|NCT02019641|Other|No Intervention|Education Only
16119027|NCT02019641|Other|Aerobic Exercise Training (AET)|walking on a treadmill at vigorous intensity for up to 45 minutes
16119048|NCT02019485|Drug|Tapentadol Extended Release (ER) Tamper-Resistant Formulation (TRF)|Participants will receive a single dose of tapentadol ER TRF 100 mg tablet orally (by mouth) in treatment sequences AB and BA appropriately.
16119049|NCT02019485|Drug|Tapentadol Prolonged-Release Formulation 2 (PR2)|Participants will receive a single dose of tapentadol PR2 100 mg tablet orally in treatment sequences AB and BA appropriately.
16119132|NCT02018861|Drug|Itacitinib|
16119028|NCT02019628|Dietary Supplement|Rice Bran Arabinoxylan Compound (RBAC)|Participants enrolled in the study will receive BRM4 at a dosage level of either 1 gram/day or 3 gram/day for the 60-day period. Subjects will be instructed to not consume any known immune-active pharmaceutical agents, nutritional supplements containing vitamins C and D, and/or any mushroom products for two weeks prior to having the baseline assessments and until the conclusion of the 60-day period. According to the company's literature, RBAC is a water soluble extract of rice bran that has been acted upon by an enzyme complex extracted from Shiitake mushroom. BRM4 contains: microcrystalline cellulose, hypromellose, sucrose fatty acid ester, gellan gum, and potassium acetate.
16119029|NCT02019615|Device|transcranial direct current stimulation|anodal transcranial direct current stimulation on the left dorsolateral prefrontal cortex for the anodal session and sham stimulation (5secondes of tDCS) for the sham session
16119030|NCT02019602|Procedure|Blood sampling from mother|A blood sample from the mother will be taken within 24 hours before/after the delivery.
16119031|NCT02019602|Procedure|Blood sampling from infant|Blood samples from the infant will be taken within 24 hours after birth, at Week 4 and at Week 8.
16119032|NCT02019602|Procedure|Blood sampling from umbilical cord|A blood sample from the umbilical cord will be taken directly (within 1 hour ) after delivery.
16119033|NCT02019602|Biological|Certolizumab Pegol|"Mothers who decided to continue on, or to start treatment with, CZP for an approved indication with their treating physician prior to participation into this study. The mother is responsible for procuring her own supply of commercial CZP. The CZP dose and administration schedule will be as per the locally approved label.
~Active Substance: Certolizumab Pegol
~Pharmaceutical Form: Solution for injection
~Concentration: 200 mg/ml
~Route of Administration: Subcutaneous Use"
16119034|NCT02019589|Drug|Progesterone|
16119035|NCT02019589|Drug|Placebo|
16119036|NCT02019576|Radiation|Stereotactic radiotherapy|SRT to all areas of oligo-progression as follows: BRAIN: 20-24 Gy in 1 fraction if < 2 cm,18 Gy in 1 fraction if 2-3 cm,15 Gy in 1 fraction for 3-4 cm, alternatively 25-30 Gy in 5 fractions can be used; SPINE: 18-24 Gy in 1-2 fractions,24 Gy in 3 fractions or 30-40 Gy in 5 fractions; NON-SPINE BONE: 30-40 Gy in 5 fractions; LUNG: 48-60 Gy in 4 fractions or 54-60 Gy in 3 fractions for peripheral lung tumours,50 Gy in 5 fractions or 60 Gy in 8 fractions for central lung tumours; LIVER: 30-60 Gy in 3-6 fractions,higher doses for central liver lesions and lower doses for peripheral liver lesions depending on proximity to adjacent organ (stomach, small bowel, large bowel or kidney); ADRENAL OR KIDNEY TUMOURS: 30-40 Gy in 5 fractions; LYMPHADENOPATHY: 30-40 Gy in 5 fractions.
16119037|NCT02019563|Procedure|RCT Group|After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and the pulp tissue removed. The canal will be irrigated with water and then filled with non-reinforced ZOE.
16119038|NCT02019563|Procedure|MTA/FS pulpotomy Group|After complete removal of all caries, if a pulp exposure is detected the pulp chamber will be opened and vital coronal pulp to a depth of 2mm below free gingival margin will be removed. A solution of ferric sulfate will be applied to the amputated pulp surface and then flushed with water. MTA paste is then used to cover over the exposed amputated pulp surface.
16119039|NCT02019550|Device|Rebif Rebidose|Rebif 44 mcg will be injected subcutaneously three times a week using Rebif Rebidose self-injector device.
16119040|NCT02019550|Device|Rebiject II|Rebif 44 mcg will be injected subcutaneously three times a week using Rebiject II self-injector device.
16119041|NCT02019537|Procedure|Steroid injection into the subacromial space|"Group: Steroid
~Total volume of injection drugs: 4ml(1ml of triamcinolone acetonide 40mg/ml + 3ml of 2% lidocaine)
~The number of injections : only once during the study period
~Injection site : subacromial space
~Material : 25-gauze spinal needle
~Subacromial injections were performed using ultrasonographic guidance."
16119042|NCT02019537|Procedure|Allogeneic PRP injection into the subacromial space|"Group: Allogeneic PRP
~Total volume of injection drugs: 4ml
~The number of injections : only once during the study period
~Injection site : subacromial space
~Material : 25-gauze spinal needle
~Subacromial injections were performed using ultrasonographic guidance."
16119043|NCT02019524|Biological|E39 peptide vaccine|500mcg of lyophilized E39 peptide is suspended in bacteriostatic saline for injection and then frozen. At the time of vaccine administration, one vial of frozen suspended peptide is thawed and mixed with 250mcg GM-CSF in the syringe. This constitutes the E39 peptide vaccine. For patients randomized to the E39 vaccine arm, the primary vaccine series (PVS) consists of E39 vaccine administered intradermally every three to four weeks for six total vaccinations. After completion of the PVS, patients are assessed for significant residual immunity (SRI). Patients with SRI will be randomized to receive one inoculation of either the E39 vaccine or the J65 vaccine. Patients without SRI will be randomized to receive one inoculation of either the E39 vaccine or the J65 vaccine.
16119044|NCT02019524|Biological|E39 vaccine then J65 vaccine|The E39 vaccine is prepared as noted above. For the J65 vaccine, 500mcg J65 peptide is suspended in bacteriostatic saline for injection and then frozen. At the time of vaccine administration, one vial of frozen suspended E39 peptide is thawed and mixed with 250mcg GM-CSF in the syringe. This constitutes the J65 vaccine. For patients randomized to this arm, the primary vaccine series (PVS) consists of the E39 vaccine administered intradermally every 3-4 weeks for 3 total vaccinations. Patients are then administered the J65 vaccine every 3-4 weeks for a total of 3 vaccinations. After completion of the PVS, patients are assessed for significant residual immunity (SRI). Patients with SRI will be randomized to receive 1 inoculation of either the E39 vaccine or the J65 vaccine. Patients without SRI will be randomized to receive 1 inoculation of either the E39 vaccine or the J65 vaccine.
16119045|NCT02019524|Biological|J65 vaccine then E39 vaccine|The E39 and J65 vaccines are prepared as noted above. For patients randomized to this arm, the primary vaccine series (PVS) consists of the J65 vaccine administered intradermally every 3-4 weeks for 3 total vaccinations. Patients are then administered the E39 vaccine every 3-4 weeks for a total of 3 vaccinations. After completion of the PVS, patients are assessed for significant residual immunity (SRI). Patients with SRI will be randomized to receive 1 inoculation of either the E39 vaccine or the J65 vaccine. Patients without SRI will be randomized to receive 1 inoculation of either the E39 vaccine or the J65 vaccine.
16119046|NCT02019498|Behavioral|Relaxation exercise|Participants allocated to the relaxation group will apply daily but at least five days a week a 15-minutes relaxation exercise, guided by a smartphone application (App). On a daily basis, participants can select one out of the three exercises (guided imagery, mindfulness based training, autogenic training) which they want to apply
16119050|NCT02019472|Biological|adalimumab 40 mg|SC injections
16119053|NCT02019472|Drug|Placebo|SC injections
16119054|NCT02019459|Other|Very low nicotine content cigarettes|
16119055|NCT02019459|Other|standard nicotine content cigarettes|
16119056|NCT02019446|Device|Laser Treatment YAG laser|YAG Laser / FOX Laser
16119057|NCT02019446|Drug|Standard Treatment (control group) terbinafine hydrochloride tablets|Terbinafine hydrochloride tablets tablets
16119058|NCT02019433|Device|Structan®|
16119059|NCT02019420|Drug|Tedizolid phosphate|Tedizolid phosphate IV 200 mg once daily
16119060|NCT02019420|Drug|Linezolid|Linezolid IV 600 mg twice daily
16119061|NCT02019407|Procedure|PVI, CTI block|"PVI (pulmonary isolation)
~Catheter ablation of cavo-tricuspid isthmus line for treatment of atrial fibrillation
~Catheter is inserted into inferior venacava (IVC) and right atrium (RA) via femoral vein. And the procedure is to block bidirectionally between inferior venacava (IVC) and the annulus of tricuspid valve (TV) by using electrical energy of catheter tip."
16119062|NCT02019407|Procedure|PVI|PVI (pulmonary isolation)
16119063|NCT02019394|Drug|Lu AE58054|"Oral dosing: 90 mg Lu AE58054 as a single dose once and after a 3 days washout period, once daily for 7 days.
~Intravenous dosing: 90 μg/not more than (NMT) 1000 nCi/37 kBq 14C-Lu AE58054 for intravenous infusion once on Day 10."
16119064|NCT02019381|Dietary Supplement|Endocrine Society UL Dosage Vitamin D|Endocrine Upper limit arm will get 10,000IU Vitamin D and 1200mg Calcium
16119065|NCT02019381|Dietary Supplement|Institute of Medicine Dosage Vitamin D|IOM arm will get 600 IU Vitamin D and 1,200 mg Calcium
16119066|NCT02019381|Dietary Supplement|Calcium|1200mg of CaCO3 supplementation will be given to each participant in both groups
16119067|NCT02019368|Dietary Supplement|Placebo|
16119068|NCT02019368|Dietary Supplement|Aged garlic extract|
16119069|NCT02019355|Drug|5-fluorouracil 5% cream|
16119070|NCT02019355|Drug|Calcipotriol 0.005% ointment|
16119071|NCT02019355|Drug|Vaseline|
16119072|NCT02019342|Other|FACE quality improvement initiative (see below)|Feedback (F): Regular feedback to practitioners; MAP Alerts (A): Change in electronic alert systems for high and low mean arterial pressure with patient specific alerts; Checklist (C): Interactive checklist in relation to the quality improvement initiative; Education campaign (E): Education campaigns about best intraoperative management of blood pressure.
16119073|NCT02019342|Other|Pre-quality improvement initiative|Patients in the pre-quality improvement initiative arm would receive current standard practice.
16119074|NCT02019329|Other|Placebo|Oral daily administration from Days 1-12
16119075|NCT02019329|Drug|RO5545965|Oral daily administration from Days 1-12
16119076|NCT02019329|Drug|risperidone|13 day run-in phase until 4 mg daily dose level is reached. 4 mg daily oral dose until Day 17 of study, for a total of 30 days. Dose may be increased up to 6 mg at the investigator's discretion. After study treatment, risperidone dosage may be decreased, increased or omitted at the investigator's discretion during a wash-out phase while patients return to their chronic antipsychotic treatment. Patient response during wash-out will be monitored in-house for 48 hours after the last dose of RO5545965 or placebo is administered. This in-house observation may be extended as needed by the investigator.
16119077|NCT02019316|Dietary Supplement|BioSteel Sports Drink|Participants will ingest 500ml of BioSteel Sports Drink 3 times during an exercise session.
16119078|NCT02019316|Dietary Supplement|Isoenergetic Control|Participants will ingest 500ml of Gatorade 3 times during an exercise session.
16119079|NCT02019303|Procedure|FNA and Core biopsy|Both procedures will be performed on the same lymph node
16119080|NCT02019290|Drug|Midazolam|Single oral doses will be given on Days 1 and 15, after an overnight fast.
16119081|NCT02019290|Drug|bitopertin|An oral dose will be given daily in the morning from Days 2-15. On Days 14 and 15, bitopertin will be given after an overnight fast; on Days 2-13, bitopertin will be given under fed conditions.
16119082|NCT02019277|Drug|Docetaxel|Dosing regimen to be determined by the investigator, routine clinical practices.
16119083|NCT02019277|Drug|Nab-paclitaxel|Dosing regimen to be determined by the investigator, routine clinical practices.
16119084|NCT02019277|Drug|Paclitaxel|Dosing regimen to be determined by the investigator, routine clinical practices.
16119085|NCT02019277|Drug|Pertuzumab|Pertuzumab will be administered on Day 1 of the first treatment cycle as a loading dose of 840 mg, followed by 420 mg as an IV infusion every 3 weeks.
16119086|NCT02019277|Drug|Trastuzumab|Trastuzumab will be administered at a fixed dose of 600 mg SC every 3 weeks.
16119087|NCT02019264|Drug|Lorcaserin hydrochloride|APD356 10 mg twice daily
16119088|NCT02019264|Drug|Placebo|Placebo twice daily
16119089|NCT02019251|Drug|perfluorinated gas/oxygen mixture|Subjects are imaged with MRI one time with the use of perfluorinated gas / oxygen mixtures as an MRI contrast agent for lung function.
16119090|NCT02019251|Device|MRI|
16119091|NCT02019238|Other|Pulmonary Vein Isolation procedure|comparing the efficacy of PVI ablation vs PVI combined with empiric ablation
16119092|NCT02019225|Other|Dialysis session of at least 4.25 hours|Facilities randomized to the Intervention arm will adopt the practice of recommending dialysis session durations of at least 4.25 hours for all patients initiating hemodialysis treatment regardless of body size or dialysis solute clearance measurements.
16119093|NCT02019186|Dietary Supplement|Vitamin C|<30 kg 250 mg 30-60 kg 500 mg >60 kg 750 mg
16119094|NCT02019186|Dietary Supplement|Vitamin E|<30 kg 100 IU, 30-60 kg 200 IU, >60 kg 300 IU
16119095|NCT02019173|Behavioral|Boot Camp Balance Training|Intense physical rehabilitation directed at improving balance and mobility will be provided to individuals in a group setting (6 participants in a group) for 4 weeks, 3 days a week for 6 hours per day.
16119096|NCT02019160|Drug|25% AgNO3 solution followed by 5% NaF varnish|Dosage of 4.4μg±1.4μg fluoride per use
16119097|NCT02019160|Drug|38% SDF solution followed by placebo varnish|Dosage of 8.8μg±2.8μg fluoride per use
16119098|NCT02019134|Behavioral|relaxation exercise|relaxation exercise
16119099|NCT02019134|Other|ususal care|
16119133|NCT02018861|Drug|Rituximab|
16119134|NCT02018861|Drug|Ifosfamide|
16119135|NCT02018861|Drug|Carboplatin|
16119136|NCT02018861|Drug|Etoposide|
16119137|NCT02018848|Behavioral|Attention Training Program|
16119138|NCT02018835|Device|MRI|
16119139|NCT02018835|Device|cardiac echography transthoracic|
16119100|NCT02019108|Other|Progressive walking program with toe-out gait modification|Participants in this study group will perform continuous treadmill walking for a minimum of 30 minutes at each session, but the emphasis will be to increase toe-out angle by 10 degrees over that exhibited at baseline. A mirror will be provided for biofeedback and participants will be instructed on its use for achieving the target toe-out angle. Increased walking time and distance will be encouraged the same as for the control group.
16119101|NCT02019108|Other|Progressive walking program|At each scheduled visit, participants will perform treadmill walking for a minimum of 30 minutes depending on the individual's baseline activity level and the stage of the intervention. Emphasis will be solely on increasing walking time and distance to achieve the target of a 40% increase in daily activity.
16119102|NCT02019095|Other|Bronchoscopy for the sampling of bronchoalveolar lavage (BAL) fluid|
16119103|NCT02019082|Device|Electrical Stimulation (BTL-5000 series, United Kingdom)|Direct current ES
16119104|NCT02019082|Device|placebo|the intervention procedure was the same as that the ES group, but the current intensity was zero
16119105|NCT02019069|Drug|liposomal cytarabine-daunorubicin CPX-351|Given IV
16119106|NCT02019056|Drug|Placebo /bid P.O|
16119107|NCT02019056|Drug|MG-1|
16119108|NCT02019056|Drug|MG-2 : MG1000mg, Placebo /bid P.O|
16119109|NCT02019056|Drug|metadoxine|
16119110|NCT02019043|Other|Syphilis testing with routine HIV bloodwork|The intervention condition will be implemented as standing orders for syphilis serology whenever patients undergo their standard battery of follow-up bloodwork, i.e., when there is an order for HIV viral load or CD4 cell count. It is standard practice for HIV patients to undergo such tests every 3-6 months. We anticipate that the change in practice will be straightforward, involving minimal training of clinic staff. Team members who are physicians at these clinics will guide the specific approach that will be appropriate and sustainable for their setting. Options are quite simple. They include pre-printing a checkmark for 'syphilis serology' onto existing pre-printed requisitions for routine bloodwork; addition of the serology request form to the routine blood work package; or programming 'syphilis serology' into existing computerized routine order sets.
16119111|NCT02019017|Drug|Botulinum Toxin Type A 25 IU|
16119112|NCT02019017|Drug|Botulinum Toxin Type A 50 IU|
16119113|NCT02019004|Drug|Onabotulinum Toxin A|
16119114|NCT02019004|Drug|Incobotulinum Toxin A|
16119115|NCT02018991|Procedure|Everolimus-Eluting Stent (EES)|Patients treated with EES
16119116|NCT02018991|Procedure|Zotarolimus-Eluting-Stent (ZES)|Patients treated with ZES
16119117|NCT02018991|Procedure|Biolimus-Eluting-Stent (BES)|Patients treated with BES
16119118|NCT02018978|Behavioral|Comprehensive Triaged HIV Prevention (CTHP)|"HIV Voluntary Counseling and Testing at Community Prevention Center-The center will be open to all community members.
~Community Mobilization-HIV/AIDS and VCT information will be disseminated with pamphlets, community discussions, and meetings.
~Risk Assessment and Triaged Counseling and Recruitment-Clients identified at high-risk for HIV infection and HIV-infected clients we be offered an additional counseling session. Participation will be incentivized. These clients will also be provided with up to 3 referral cards to give to sexual partners. If partners come for VCT, they will receive a small incentive.
~Incentives & Support Activities - Modest and ethically appropriate incentives, including those providing nutritional support (food), health and hygiene benefits (bed nets), transport to access interventions, or income generation potential, will be provided for participation in some project interventions, and these will be graduated based on HIV risk potential."
16119119|NCT02018965|Drug|Niacin|"• Group 1: This group will receive an initial dose of ER niacin 500 mg by mouth, the first evening from week 0 to week 4 then increase it to 1000 mg once a day from week 5 to week 8, then increase to 1500 mg from week 9 to week 12 then increase to 2000 mg until weeks 24 and then stopped.
~Participants will continue to take their ART treatment as prescribed throughout the study."
16119120|NCT02018965|Drug|Niacin|"• Group 2: This group will not receive ER niacin for the first 24 weeks. This group will receive an initial dose of ER niacin 500 mg the first evening at week 25 by mouth from week 25 to week 28 then increase it to 1000 mg once a day from week 29 to week 32, then increase to 1500 mg from week 33 to week 36 then increase to 2000 mg until week 48 and then stopped.
~Participants will continue to take their ART treatment as prescribed throughout the study."
16119121|NCT02018952|Other|Ultrasonography assessment|"All patients will be seen at day 0, day 4, day 15 and at 3 months. These visits are usually programmed. Only monitoring ultrasonography, a non invasive exam, and self-administered questionnaires will be made, additional to standard exams for all patients included (no control group).
~Day 0 :
~Information of patient and no opposition getting
~Clinical exam
~Laboratory tests
~Radiography of the targeted joint
~Ultrasonography of the targeted joint and controlateral joint (about 20 minutes)
~Day 4 :
~Clinical exam
~Laboratory tests
~Ultrasonography of the targeted joint and controlateral joint (about 20 minutes)
~Day15 :
~Clinical exam
~Laboratory tests
~Ultrasonography of the targeted joint and controlateral joint (about 20 minutes)
~M3 :
~Clinical exam
~Laboratory tests
~Radiography of the targeted joint
~Ultrasonography of the targeted joint and controlateral joint (about 20 minutes)
~Functional outcome"
16119122|NCT02018939|Other|Pharmacokinetic profiling|Pharmacokinetic samples are taken from each Patient receiving Doripenem in each arm. No other interventions are performed during this trial. Doripenem is not administered due to the trial.
16119123|NCT02018926|Drug|Mocetinostat|Mocetinostat (a histone deacetylase [HDAC] inhibitor) 70 mg or 90 mg dose, oral capsules 3 times weekly beginning on day 5, for 10 doses in each 28 day cycle
16119124|NCT02018926|Drug|Azacitidine|Azacitidine (a hypomethylating agent [HMA]) 75 mg/m2 dose, by intravenous (IV) infusion or subcutaneous (SC) injection beginning on day 1 for 7 doses in each 28 day cycle
16119125|NCT02018900|Dietary Supplement|Ecologic 825/scFOS|
16119126|NCT02018900|Dietary Supplement|Placebo|
16119127|NCT02018887|Drug|LY2969822|Capsules administered orally
16119128|NCT02018887|Drug|Placebo|Capsules administered orally
16119129|NCT02018874|Drug|LY2780301|"LY2780301 will be given orally Q.D. at different dose levels. Because of a favourable safety profile, the different dose levels will be as follow :
~Dose level -1: 300 mg Q.D.
~Dose level -0.5: 400 mg Q.D.
~Dose level 1: 400 mg Q.D.
~Dose level 1.5: 500 mg Q.D.
~Dose level 2 : 500 mg Q.D."
16119130|NCT02018874|Drug|Gemcitabine|The dose level of Gemcitabine will be fixed (1000 mg/m2). Gemcitabine will be administered over a 30 minutes infusion.
16119131|NCT02018861|Drug|Parsaclisib|
16119140|NCT02018822|Device|urethane dimethacrylate|Experimental urethane dimethacrylate resin based composite resin for teeth used with prime and Bond Elect bonding agent
16119141|NCT02018822|Device|TPH3|light-cured resin composite for teeth
16119142|NCT02018822|Device|Esthet-X HD|light cured resin composite for teeth made by Dentsply Caulk
16119143|NCT02018809|Behavioral|Medication Adherence Partner|
16119144|NCT02018809|Device|Electronic pill bottle|This device can remotely track medication taking and will be used by subjects to store once-a-day statin medication already prescribed pre-trial.
16119145|NCT02018796|Drug|Mifepristone, misoprostol|200 mifepristone, followed 24 to 48 hours later by 600 mcg misoprostol
16119146|NCT02018783|Procedure|Colgate|Slow-speed handpiece with a Robson brush for 3 seconds by repeating the procedure
16119147|NCT02018783|Procedure|Sensodyne|Digital application for 60 seconds.
16119148|NCT02018783|Procedure|Nano P|Slow-speed handpiece with a Robson brush for 10 seconds
16119149|NCT02018783|Procedure|Cocorico|Digital application for 60 seconds
16119150|NCT02018770|Radiation|Phototherapy|Portable Cluster 9 PainAway ® diodes manufactured by Multi Radiance Medical ® (Solon, OH-USA), being 1 905 nm diode (1 mW average power 10 W of peak power, spot of 0.44 cm2), 875 nm diodes 4 (17.5 mW average power for each diode, spot of 1 cm2) and 670 nm diodes 4 (15 mW average power for each diode1 spot, cm2), frequency of 1000 Hz, irradiation time of 300 seconds, energy delivered from 39.3 Joules.
16119151|NCT02018770|Radiation|Placebo phototherapy|The volunteers will be subjected to the same Groups ' intervention and placebo pen Phototherapy.
16119152|NCT02018757|Drug|TACE containing As2O3|transarterial chemoembolization containing a mixture of 20mg of arsenic trioxide, 40mg of adriamycin and some dose of 40% ultra-fluid lipiodol
16119153|NCT02018757|Drug|TACE containing placebo|transarterial chemoembolization containing a mixture of 20mg of placebo, 40mg of adriamycin and some dose of 40% ultra-fluid lipiodol
16119154|NCT02018731|Drug|Metformin and Metformin & L-Citrulline|
16119155|NCT02018731|Drug|L-Citrulline and Metformin & L-Citrulline|
16119156|NCT02018718|Device|Magnetic Resonance Imaging (MRI)|
16119157|NCT02018692|Dietary Supplement|Alga Dunaliella Bardawil powder|9 cis beta carotene rich Alga Dunaliella Bardawil powder
16119158|NCT02018692|Dietary Supplement|Placebo:Starch|Starch powder
16119159|NCT02018679|Procedure|Er:YAG AFL-PDT|AFL was performed using a 2940-nm Er:YAG ablative fractional laser (Joule, Sciton Inc., CA, UA) at 550-600 µm ablation in depth, level 1 coagulation, 22% treatment density, and a single pulse. Immediately afterwards, a 1-mm thick layer of MAL (16% Metvix® cream, PhotoCure ASA, Oslo, Norway) was applied to the lesion and to 5 mm of surrounding healthy tissue. The area was covered with an occlusive dressing (Tegaderm, 3M, Saint Paul, MN, US) for 3 hours, after which the remaining cream was removed with saline gauze, and the red fluorescence of porphyrins was visualized with Wood's light. Each treatment area was then separately illuminated with red light-emitting diode (LED) lamps (Aktilite CL128; Galderma, Bruchsal, Germany) with peak emission at 632 nm and total light dose of 37 J cm2.
16119160|NCT02018679|Procedure|MAL-PDT|a 1-mm thick layer of MAL (16% Metvix® cream, PhotoCure ASA, Oslo, Norway) was applied to the lesion and to 5 mm of surrounding healthy tissue. The area was covered with an occlusive dressing (Tegaderm, 3M, Saint Paul, MN, US) for 3 hours, after which the remaining cream was removed with saline gauze, and the red fluorescence of porphyrins was visualized with Wood's light. Each treatment area was then separately illuminated with red light-emitting diode (LED) lamps (Aktilite CL128; Galderma, Bruchsal, Germany) with peak emission at 632 nm and total light dose of 37 J cm2. Areas which were scheduled to receive MAL-PDT received the second treatment 7 days later.
16119161|NCT02018666|Device|NAVA endotracheal tube|
16119162|NCT02018653|Drug|Calcium Alumina-Silicate (CASAD)|1 gram by mouth every 6 hours for up to 6 days.
16119163|NCT02018653|Other|Placebo|1 by mouth every 6 hours for up to 6 days.
16119164|NCT02018653|Behavioral|Questionnaire|Questionnaire completion at baseline about diarrhea and other symptoms.
16119165|NCT02018627|Drug|Xeris glucagon|The subject is given an injection of xeris glucagon
16119166|NCT02018627|Drug|Lilly glucagon|The subject is given an injection of lilly glucagon
16119167|NCT02018614|Other|algoplus|
16119168|NCT02018601|Procedure|BRILMA|
16119169|NCT02018601|Procedure|paravertebral block|
16119170|NCT02018601|Drug|dexketoprofen|
16119171|NCT02018601|Drug|paracetamol|
16119172|NCT02018588|Dietary Supplement|tryptophan|graded levels of tryptophan will be given to each subject
16119173|NCT02018575|Dietary Supplement|Crystalline Lysine Amino Acid Mix|Crystalline Lysine from Amino Acid Mixture in amount of 29, 37, 46 and 54% of the mean Lysine requirement of 35 mg/kg/d will be given to subjects.
16119174|NCT02018575|Dietary Supplement|White corn meal porridge|A cornmeal porridge including 29, 37, 46 and 54% of the mean Lysine requirement of 35 mg/kg/d will be given to subjects.
16119175|NCT02018562|Device|Portex Blueline Ultra Suctionaid Tracheostomy Tube|
16119177|NCT02018536|Drug|GSK2336805 30 mg|A single dose of 1 tablet of 30 mg of GSK2336805 taken orally (by mouth) on Day 1 under fasted conditions.
16119178|NCT02018536|Drug|GSK2336805 60 mg|A single dose of 2 tablets of 30 mg ie, 60 mg of GSK2336805 taken orally (by mouth) on Day 1 under fasted conditions.
16119179|NCT02018536|Drug|GSK2336805 120 mg|A single dose of 4 tablets of 30 mg ie, 120 mg of GSK2336805 taken orally (by mouth) on Day 1 under fasted conditions.
16119180|NCT02018536|Drug|TMC435 150 mg (Treatment A)|1 capsule of TMC435 150 mg taken once daily orally (by mouth) on Days 1 to 7 under fed conditions.
16119181|NCT02018536|Drug|GSK2336805 60 mg (Treatment B and part of Treatment C and D)|2 tablets of 30 mg GSK2336805 ie, 60 mg of GSK2336805 taken once daily orally (by mouth) on Days 1 to 7 under fed conditions.
16119182|NCT02018536|Drug|TMC435 100 mg (part of Treatment C)|1 capsule of TMC435 100 mg taken orally (by mouth) on Days 1 to 7 under fed conditions.
16119183|NCT02018536|Drug|TMC435 150 mg (part of treatment D)|1 capsule of TMC435 150 mg taken orally (by mouth) on Days 1 to 7 under fed conditions.
16119184|NCT02018523|Drug|Lenalidomide|lenalidomide 10mg/day orally until disease progression
16119185|NCT02018510|Biological|1 mg/kg, single dose IV administration of 3BNC117|1 mg/kg, single dose IV administration of 3BNC117
16119186|NCT02018510|Biological|3 mg/kg, single dose IV administration of 3BNC117|3 mg/kg, single dose IV administration of 3BNC117
16119187|NCT02018510|Biological|10 mg/kg, single dose IV administration of 3BNC117|10 mg/kg, single dose IV administration of 3BNC117
16119188|NCT02018510|Biological|30 mg/kg, single dose IV administration of 3BNC117|30 mg/kg, single dose IV administration of 3BNC117
16119189|NCT02018510|Biological|10 mg/kg, two doses IV of 3BNC117|10 mg/kg, two IV administrations of 3BNC117 at weeks 0 and 12
16119190|NCT02018510|Biological|30 mg/kg, two doses IV of 3BNC117|30 mg/kg, two IV administrations of 3BNC117 at weeks 0 and 12
16119191|NCT02018484|Procedure|Unicompartmental Knee Replacement|
16119192|NCT02018471|Behavioral|Psychoeducative training|The Psychological education was inspired by the technique, Systematic Desensitization (SD), a therapeutic procedure that seeks to eliminate fear and avoidance behaviour
16119193|NCT02018458|Biological|LA TNBC: DC vaccine+Preop chemo|LA TNBC patients will receive standard preop AC followed by TCb chemo for 24 weeks. Chemo and DC vaccinations will be given intratumoral and subcutaneous for 4 times prior surgery. During the AC cycles, vaccines will be given on any day between Days 9-12 of Cycles 1 and 3 of AC. Vaccines will be given on any day between Days 11-15 of Cycles 1 and 3 of TCb. Patients will undergo biopsies of their cancer prior to treatment and 1-2 days prior to or on Day 1 of Cycle 4 of AC. After this, patients will have surgery, locoregional radiation therapy to the breast or chest wall and regional lymphatics per standard of care, and will receive 3 boost DC vaccinations subcutaneously, rotating injection sites in the upper arm. The 1st vaccination will occur after the surgery and prior to radiation; 2nd will occur 30 days ± 3 days after radiation; the 3rd will occur 90 days ± 3 days after the 2nd boost.
16119194|NCT02018458|Biological|ER+/HER2-BC:DC vaccine+Preop chemo|ER+/HER2- BC patients will receive standard preop AC followed by weekly T given for 22 weeks. Chemo and DC vaccinations will be given intratumoral and subcutaneous, for 4 times prior surgery. During the AC cycles, vaccines will be given any day between Days 9-12 of Cycles 1 and 3 of AC. Vaccines will be given on Day 1 during Cycle 2 or Cycle 3 and on Day 1 during either Cycle 8 or Cycle 9 of T. Vaccine will be given after T infusion is completed. Patients will undergo biopsies of their cancer prior to treatment and 1-2 days prior to or on Day 1 of Cycle 4 of AC. Patients will have surgery, locoregional radiation therapy to the breast or chest wall and regional lymphatics per standard of care, and will receive 3 boost DC vaccinations subcutaneously, rotating injection sites in the upper arm. The 1st vaccination will occur after surgery and prior to radiation; the 2nd will occur 30 days ± 3 days after radiation; and the 3rd will occur 90 days ± 3 days after the 2nd boost.
16119195|NCT02018445|Procedure|Posterolateral Fusion|
16119196|NCT02018432|Drug|Roflumilast escalation dosage|"This is a randomized, prospective, open label, comparative study to assess whether the administration of roflumilast by dose escalation varies the incidence of discontinuations due to adverse events when compared with the usual dosage in severe and very severe COPD patients.
~Roflumilast 250 μg once daily for 4 weeks and then increased dose of Roflumilast 500 μg once daily for 12 weeks"
16119197|NCT02018432|Drug|Roflumilast conventional dosage|Roflumilast 500 μg once daily for 12 weeks
16119198|NCT02018419|Biological|AlloStim|AlloStim is derived from the blood of normal blood donors and is intentionally mismatched to the recipient.
16119199|NCT02018419|Procedure|Cryoablation|Percutaneous ablation of a single metastatic tumor lesion usually in liver or bone. The procedure is conducted under CT or ultrasound image-guidance.
16119200|NCT02018406|Drug|Combination injection of EPO and G-CSF|Subcutaneous EPO(300 U/kg)+G-CSF(10 μg/kg) injection once a day, 5 times a cycle (a week), total 3 cycles for 3 months.
16119201|NCT02018406|Drug|Injection of normal saline|Subcutaneous normal saline injection once a day, 5 times a cycle (a week), total 3 cycles for 3 months.
16119202|NCT02018380|Other|Shock Absorbing Insole (SofSole Athletes Plus)|The shock absorbing insole used in this study was the SofSole Athletes Plus, (Implus Inc, Durham, NC), recommended by the manufacturer for repetitive activities such as running and walking. It is readily available in most athletic shoe stores, retailing for under $20.00. The insole is full-length with a curved last made of Implus XP that has a shore A durometer reading of 60 (0 = softest to 100 = hardest).
16119203|NCT02018367|Drug|Proflavine, high resolution imaging|5-10mL of proflavine hemisulfate (0.01%) will be sprayed on the esophageal mucosa. The HRME will then be inserted through the biopsy channel of the endoscope and gently placed against the mucosa. The endoscopist will image each discrete lesion observed during white light endoscopy. For each HRME imaged area, an optical read will be obtained followed by a tissue biopsy.
16119204|NCT02018354|Procedure|Lateral Extra-Articular Tenodesis (LET)|Lateral extra-articular tenodesis: A 1cm wide x 8cm long strip of iliotibial band is fashioned, leaving the Gerdys tubercle attachment intact. The graft is tunneled under the fibular collateral ligament (FCL) and attached to the femur with a Richards' staple (Smith & Nephew), just distal to the intermuscular septum, proximal to the femoral insertion of the FCL. Fixation is performed with the knee at 70 degrees flexion, neutral rotation. Minimal tension is applied to the graft. The free end is then looped back onto itself and sutured using the No. 1 vicryl.
16119205|NCT02018354|Procedure|ACL Reconstruction|Anatomic ACL reconstruction using a four-strand autologous hamstring graft. If the diameter of the graft is found to be less than 7.5mm, semitendinosus will be tripled (5 strand graft) providing a greater graft diameter. Femoral tunnels will be drilled using an anteromedial portal technique, with femoral fixation provided by an Endobutton or equivalent. Tibial fixation will be provided by interference screw.
16119206|NCT02018341|Other|homeopathic remedy in 30C potency|
16119207|NCT02018341|Other|Placebo|
16119208|NCT02018328|Dietary Supplement|Curcumin|
16119209|NCT02018315|Drug|Triheptanoin|Triheptanoin is a 7-carbon medium chain triglyceride
16119210|NCT02018302|Drug|Triheptanoin|
16119211|NCT02018289|Procedure|Triclosan coated suture|Suture of the abdominal wall with triclosan coated suture
16119212|NCT02018289|Procedure|No triclosan|Suture of the abdominal wall with suture without triclosan coat
16119213|NCT02018276|Drug|Lidocaine|The administered drugs for each group were prepared by an anesthetist who did not participate in the study according to directions given by the patient in charge of the study. (for Lidocaine Group, 1% lidocaine 40 mL was prepared in a 50 mL syringe
16119214|NCT02018276|Drug|Magnesium|The administered drugs for each group were prepared by an anesthetist who did not participate in the study according to directions given by the patient in charge of the study. (for Magnesium Group, MgSO4 4g 40 mL was prepared in a 50 mL syringe)
16119215|NCT02018263|Drug|Cocaine hydrochloride|
16119216|NCT02018263|Behavioral|Exercise|
16119217|NCT02018263|Drug|Nicotine|
16119218|NCT02018250|Drug|MMB4 DMS|Subjects will be administered the drug product formulation at the assigned dosage of MMB4 DMS or placebo i.m. to the anterior thigh using a 5 mL syringe.
16119219|NCT02018250|Drug|Placebo|Subjects will be administered the drug product formulation at the assigned dosage of placebo i.m. to the anterior thigh using a 5 mL syringe. The placebo group in each cohort will receive the same injection volume and number of injections as the dose group in that cohort.
16119220|NCT02018237|Behavioral|High fructose corn syrup diet|Subjects will consume a high fructose corn syrup diet for 4 weeks. The food will be prepared by the bio-nutrition kitchen, and meals will be picked up every 3-4 days.
16119221|NCT02018237|Behavioral|Standard diet (low in high fructose corn syrup)|Subjects will consume a standard diet (low in high fructose corn syrup) for 4 weeks. The food will be prepared by the bio-nutrition kitchen, and meals will be picked up every 3-4 days.
16119222|NCT02018224|Procedure|End-to-end suturation without augmentation|End-to-end suturation without augmentation; Irregular tendon ends were cleaned and repaired by the Krackow technique with two separate 0-gauge absorbable sutures.
16119223|NCT02018224|Procedure|End-to-end suturation with augmentation.|End-to-end suturation with augmentation; End-to-end suturation as above with a 10 mm wide central gastrocnemius aponeurosis flap, as proposed by Silfverskjöld.
16119224|NCT02018211|Other|control|passive recovery following exercise test
16119225|NCT02018211|Device|graduated compression socks|graduated compression socks worn after test exercise
16119226|NCT02018211|Device|neuromuscular electrical stimulation device|neuromuscular electrical stimulation device worn after test exercise
16119227|NCT02018198|Diagnostic Test|FebriDx|Point of Care Host Immune Response Test
16119228|NCT02018185|Device|Transcranial Magnetic Stimulation|A non-invasive method for brain stimulation
16119229|NCT02018185|Device|Sham Transcranial Magnetic Stimulation|Sham stimulation of the brain.
16119230|NCT02018172|Drug|somatropin|
16119231|NCT02018159|Drug|menotropin|
16119232|NCT02018146|Other|Mask then nasopharyngeal|Patients will be randomly assigned to Mask ventilation followed by naso-pharyngeal ventilation
16119233|NCT02018146|Other|Nasopharyngeal then mask|Patients will be randomly assigned to naso-pharyngeal ventilation followed by mask ventilation.
16119234|NCT02018133|Drug|Vitamin D 2mg daily for 2 weeks oral paricalcitol|vitamin D 2 capsules daily
16119235|NCT02018133|Drug|Placebo|placebo 2 capsule daily
16119236|NCT02018120|Procedure|connective tissue graft|
16119237|NCT02018120|Procedure|platelet rich fibrin|
16119238|NCT02018107|Diagnostic Test|N-13 ammonia or F-18 fluorodeoxyglucose|PET tracer
16119239|NCT02018107|Diagnostic Test|PET scan|PET scan
16119240|NCT02018094|Drug|Co-amoxiclav|Augmentin 1.2g IV three times daily for 24 hours. If the patient is randomised to the 5-day duration antibiotic arm then Augmentin 625mg oral tablets three times daily are added to the 24 hour course for a further 4 days.
16119241|NCT02018094|Drug|Iodine|Intra-operative skin preparation prior to incision to skin.
16119242|NCT02018094|Drug|Metronidazole|500mg IV three times daily for 24 hours. If the patient is randomised to 5-day duration arm, then another 4 days of oral metronidazole at 400mg three times daily is added to the course
16119243|NCT02018094|Drug|Chlorhexidine|Alcoholic Chlorhexidine skin pre-op preparation
16119244|NCT02018094|Drug|Teicoplanin|Teicoplanin 400mg on induction. If penicillin allergic and on 5-day antibiotic arm then add clindamycin 300mg 4 times daily for further 4 days
16119245|NCT02018094|Drug|Clindamycin|Clindamycin 300mg 4 times daily orally to be used in case of penicillin allergy
16119246|NCT02018081|Drug|Levofloxacin|8 blood sampling by patients between the 48th and 60th
16119247|NCT02018068|Other|Remote control|When pain or sensory and motor block evaluation exceed the thresholds, the patient enters the data in the PCA (patient Control Analgesia) pump. The investigator is alerted by SMS on his smartphone and makes the necessary programming changes by remote control on the Micrel Care TM site. Systematic assessments via the PCA pump are scheduled for 9:00, 13:00 and 19:00 every day during 48 to 72 hours. The patient can alert his physician through his PCA pump of any additional requests (pain, motor blockade, numbness). The anesthesiologist receives an SMS alert and can make any necessary programming changes to the pump via the remote control.
16119248|NCT02018068|Other|At bedside care|When pain or sensory and motor block evaluation exceed the thresholds, the nurse contacts the physician and she will be able to modify the pump settings according to the anesthesiologist prescription. The delay between the call of the patient and the programming changes, the duration of the procedure are reported. Systematic evaluations via the PCA (Patient Control Analgesia) pump are done when the patient arrives in this surgical ward and at 9:00, 13:00 and 19:00 every day for 48 to 72 hours.Throughout the study, if necessary, the nurse or referring physician performs the programming changes directly on the PCA pump and notes the delay in treatment. All the reasons and the duration of any bedside visit are reported.
16119249|NCT02018055|Drug|Aspirin+Ticagrelor|Aspirin+ Ticagrelor after 1month of standard DAPT (Aspirin+Ticagrelor)
16119250|NCT02018055|Drug|Aspirin+Clopidogrel|Aspirin+ Clopidogrel after 1month of standard DAPT (Aspirin+Ticagrelor)
16119251|NCT02018042|Drug|Abatacept|"After the screening period, subjects will begin weekly self-administered subcutaneous abatacept and will continue treatment for 6 months. Patients will be instructed in self-administration of study medication at baseline (week zero) and will be observed self-administering medication at each visit. Instructions regarding study drug administration will be reinforced as needed.
~The 6-month treatment period is expected to provide adequate time to assess the short-term efficacy and safety of abatacept in patients with moderate to severe AAP. Responders will then be followed for 6 months off drug."
16119252|NCT02018029|Other|cardiac resynchronisation therapy|
16119253|NCT02017964|Drug|Carboplatin|Given IV
16119254|NCT02017964|Other|Cognitive Assessment|Optional ancillary studies
16119255|NCT02017964|Drug|Cyclophosphamide|Given IV
16119256|NCT02017964|Drug|Etoposide|Given IV
16119257|NCT02017964|Other|Laboratory Biomarker Analysis|Correlative studies
16119258|NCT02017964|Drug|Methotrexate|Given IV
16119259|NCT02017964|Drug|Vincristine Sulfate|Given IV
16119342|NCT02017249|Drug|arginine in powder form|
16119260|NCT02017938|Procedure|Virtual Reality anti-fatigue ergo cycling training (Self-made)|To establish a Virtual Reality systems to reduce fatigue of cycling training for PD subjects.
16119261|NCT02017925|Behavioral|exercise intervention|Undergo pulmonary rehabilitation
16119262|NCT02017925|Procedure|pulmonary complications management/prevention|Undergo pulmonary rehabilitation
16119263|NCT02017925|Procedure|quality-of-life assessment|Ancillary studies
16119264|NCT02017925|Other|questionnaire administration|Ancillary studies
16119265|NCT02017912|Biological|Autologous MSC-NTF cells|Single autologous MSC-NTF cells treatment by combined intramuscular and intrathecal administration
16119266|NCT02017912|Biological|Placebo|Excipient administration by combined intramuscular and intrathecal administration
16119267|NCT02017899|Biological|S. sonnei 1790GAHB|
16119268|NCT02017899|Biological|Placebo|
16119269|NCT02017886|Dietary Supplement|L. reuteri DSM 17938/ATCC PTA|L. reuteri DSM 17938/ATCC PTA twice daily for three weeks
16119270|NCT02017886|Dietary Supplement|Placebo|Placebo tablet twice daily for three weeks
16119271|NCT02017873|Drug|Peroxide Carbamide 10% - Dental bleaching treatment|During 3 hours in 3 weeks of bleaching in both groups in healthy patients and smokers patients
16119272|NCT02017860|Drug|Everolimus|Everolimus was provided by the investigator in 2.5 mg or 5 mg tablets for daily oral administration.
16119273|NCT02017834|Procedure|surgical resection|neck dissection and tumour resection will be performed either with or without the harmonic scalpel as an adjunct.
16119274|NCT02017821|Behavioral|high intensity aerobic training|
16119275|NCT02017795|Other|electronic asthma action plan (eAAP)|An electronic asthma action plan (eAAP) will be provided to intervention group
16119276|NCT02017795|Other|written asthma action plan (WAAP)|A written asthma action plan will be given to control group arm
16119277|NCT02017782|Device|Dust|Dust (250-300µg/m3),
16119278|NCT02017782|Device|Ozone|(0,1ppm ozone),
16119279|NCT02017782|Device|Dust and Ozone|Active Dust (250-300 ug/m3)+Ozone(0,1ppm)
16119280|NCT02017782|Device|Placebo (Filtered air)|Placebo treatment (Filtered air <20 ug/m3)
16119281|NCT02017730|Drug|BMS-986020|
16119282|NCT02017730|Drug|[11C]BMT-136088|
16119283|NCT02017717|Biological|Nivolumab|specified dose on specified days
16119284|NCT02017717|Biological|Bevacizumab|specified dose on specified days
16119285|NCT02017717|Biological|Ipilimumab|specified dose on specified days
16119286|NCT02017704|Radiation|Endo-HDR (if randomized to this arm)|Patients will be treated with a daily dose of 6.5 Gy over four consecutive days for a total of 26 Gy
16119287|NCT02017704|Drug|capecitabine and IMRT (if randomized to this arm)|Capecitabine shall be delivered at 825mg/m2 BID during IMRT radiotherapy
16119288|NCT02017704|Radiation|IMRT (intensity modulated radiation therapy)|Patients will receive IMRT along with capecitabine. External radiotherapy will be based on contouring guidelines from the RTOG atlas and Radiation Therapy Oncology Group (RTOG 0822) with some modifications
16119289|NCT02017704|Drug|FOLFOX6|"Oxaliplatin - 85 mg/m² in 500ml glucose 5% solution, 2-h infusion
~Leucovorin - bolus 400mg/m² following the oxaliplatin/FA infusions
~5 Fluorouracil (5FU) - 2400 mg/m², 46-h infusion following the 5-FU bolus An outpatient, 46 hour continuous IV infusion provided by a home IV infusion company. The 5FU is delivered by a small pump worn in a fanny pack around the waist. The home IV infusion company will arrange your disconnect at the end of the infusion."
16119290|NCT02017704|Procedure|Surgery|"After the patient has been identified as a candidate for the trial, the surgeon will assess the patient and will determine:
~Exact height and location of tumor with regards to the anal margin as measured by a rigid or flexible proctoscope and/or digital exam.
~Mobility of tumor as assessed if possible by rectal exam Type of surgical procedure: Abdominoperineal resection vs. sphincter saving procedures, which will include colo-anal with mucosectomy vs. stapled anastomosis."
16119291|NCT02017691|Device|Near Infrared Spectroscopy|If crSO2 is <10th centile, CPAP via face mask will be started or oxygen support will be increased depending SpO2, on the infants breathing efforts and the heart rate. If crSO2 remains stable >10th centile, or if crSO2 is > 90th centile CPAP via face mask will be stopped or FiO2 will be reduced depending on SpO2, the infants breathing efforts and the heart rate.
16119292|NCT02017691|Device|Pulse-oximetry|If SpO2 remains <10th centile, respiratory support via face mask will be started or FiO2 will be increased depending on the infants breathing efforts and the heart rate. If SpO2 remains stable or if SpO2 is >90th centile respiratory support via face mask will be stopped or FiO2 will be reduced depending on the infants breathing efforts and the heart rate.
16119293|NCT02017678|Biological|JX-594|5 weekly IV infusions of JX-594 followed by laparoscopy and biopsy on day 10 or 38.
16119294|NCT02017639|Drug|sarilumab SAR153191 (REGN88)|Pharmaceutical form:Prefilled syringe of sarilumab solution Route of administration: Subcutaneous injection
16119295|NCT02017639|Drug|simvastatin|Pharmaceutical form:Film-coated 20 mg Tablet Route of administration: oral
16119296|NCT02017626|Biological|mCyp c 1|2 patient groups with different doses of allergen.
16119297|NCT02017613|Drug|RP6530|Escalating doses starting at 25 mg BID
16119298|NCT02017600|Drug|ND-420|ND-420 50 mg/m2 on day1
16119299|NCT02017600|Procedure|Surgery|After induction chemotherapy, participants will be receive right or left thoracotomy for curative resection by total or subtotal thoracic esophagectomy.
16119300|NCT02017600|Drug|Cisplatin|cisplatin 70 mg/m2 on day1
16119301|NCT02017600|Drug|fluorouracil|fluorouracil 700 mg/m2 daily, day1 to day4
16119302|NCT02017574|Behavioral|Reaching Task|Learn a reaching task that requires coordination of the arm segments
16119303|NCT02017561|Behavioral|Lifestyle Counseling|Written and individualized information during the interview in all clinic visits, emphasizing the importance of a healthy lifestyle, engaging on regular moderate-intensity physical activity and eating an healthy diet.
16119304|NCT02017561|Drug|Metformin|Metformin treatment titrated to a maximum dose of 1000mg twice a day. Metformin treatment will start with 500mg at breakfast during the first week and, if well tolerated, increased to 500mg twice a day (breakfast and dinner) in the second week, 1000mg at breakfast and 500mg at dinner in the third week and finally for the target dose of 1000mg twice a day.
16119305|NCT02017548|Behavioral|Life-extension default advance directive|
16119306|NCT02017548|Behavioral|Comfort default advance directive|
16119307|NCT02017535|Drug|Fluoxetine|Prozac (fluoxetine capsules, USP) is a selective serotonin reuptake inhibitor for oral administration.
16119308|NCT02017535|Behavioral|Interpersonal Psychotherapy|Type of talk therapy that focuses on an adolescents relationship and communication skills in the context of of their depression.
16119309|NCT02017522|Device|11C-PBR PET|"Subjects will have a positron emission tomography (PET) CT scan using 11C-PBR28 as a radiotracer. This study will evaluate inflammation due to cardiac sarcoidosis. The CT scan will improve the images. The total scan time will be about 30 minutes. There will also be some time required for prep, such as inserting an intravenous (IV) catheter in an arm or forearm. Including prep time, the scan will take approximately two hours.
~Subjects will also undergo a cardiac MRI. Cardiac MRI uses strong magnetic fields to make pictures of the heart. We will use gadolinium containing contrast material, given through an intravenous (IV) catheter to highlight areas of scar in your heart which may be due to cardiac sarcoidosis. This scan will take about 60 minutes."
16119310|NCT02017509|Procedure|Diagnostic Biopsy and Surgical Procedure|A tumor sample from the diagnostic biopsy and surgical procedure will be used for research.
16119311|NCT02017509|Procedure|Intravoxel incoherent motion MRI (IVIM)|At the end of a standard MRI, we will perform IVIM, which is a diffusion-weighted imaging sequence that simultaneously characterizes the microscopic diffusivity of water and the macroscopic transport of water via bulk flow. IVIM may more accurately reflect the properties of the tumor microenvironment including vascular permeability, interstitial fluid pressure, and response to neoadjuvant therapy.
16119312|NCT02017509|Procedure|Dynamic Contrast Enhanced MRI (DCE-MRI)|Following a standard MRI scan, Dynamic Contrast Enhanced MRI (DCE-MRI) will be done. DCE-MRI is an indicator-dilution experiment in which the delivery and transcapillary transfer of a contrast agent, typically one of a number of gadolinium-based contrast agents (GBCA), is used to assess a number of parameters characterizing tissue physiology. In locally advanced rectal cancer patients, use of DCE-MRI for determining pathologic response has produced equivocal results but more promising data has been published recently in the cervical cancer literature.
16119313|NCT02017509|Genetic|RNA gene expression analysis|RNA will be collected from biopsy and surgical tissue for gene expression analysis.
16119314|NCT02017470|Other|Gender-tailored women's heart health outpatient programme|
16119315|NCT02017457|Biological|Donor lymphocyte infusion|"On day 1 of cycle 2, 4 and 6 of Azacytidine, patients will be infused with donor lymphocytes (ideally on day 1 but in case of organizational problems, DLI can be administered until day 5) .
~Patients with a sibling donor will receive:
~5x10exp7 CD3+/kg on day 1 of cycle 2
~5x10exp7 CD3+/kg on day 1 of cycle 4
~10x10exp7 CD3+/kg on day 1 of cycle 6
~Patients with an unrelated donor will receive:
~1x10exp7 CD3+/kg on day 1 of cycle 2
~5x10exp7 CD3+/kg on day 1 of cycle 4
~10x10exp7 CD3+/kg on day 1 of cycle 6"
16119316|NCT02017457|Drug|Azacytidine|"Cycle 1: Subcutaneous administration of 100mg/m2/day for 5 days.
~Cycle 2: Subcutaneous administration of 35mg/m2/day for 5 days. Cycles will be administered every 28 days.
~All patients will receive at least 6 cycles of Azacytidine except if progression requests additional disease-related treatment such as hydroxyurea or other chemotherapeutic agents. In such cases, the patient will be excluded from the study and only disease status and survival status will be reported during the 3-year follow-up period. In case of complete remission after cycle 5, 2 additional cycles will be administered after achievement of complete remission.
~In case of stable disease or partial response, Azacytidine will be continued until progression.
~In case of disease progression after cycle 6, Azacytidine will be stopped."
16119319|NCT02017431|Other|Allergen|Subject specific allergen is inhaled on day 1 of the triad
16119320|NCT02017431|Other|Saline|Saline is inhaled on day 1 of the triad
16119321|NCT02017431|Other|Particle depleted diesel exhaust|High-efficiency particulate filtration of diesel exhaust
16119322|NCT02017418|Dietary Supplement|zeaxanthin|softgel
16119323|NCT02017418|Dietary Supplement|combinatory supplement|softgel
16119324|NCT02017405|Other|Serum-derived bovine immunoglobulin protein isolate (SBI)|Serum-derived bovine immunoglobulin protein isolate is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. Serum-derived bovine immunoglobulin protein isolate does not contain any milk products such as lactose, casein, or whey. Serum-derived bovine immunoglobulin protein isolate is gluten-free, dye-free, and soy-free. Serum-derived bovine immunoglobulin protein isolate is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients.
16119325|NCT02017405|Other|Matching Placebo|
16119326|NCT02017392|Drug|Compound Lidocaine Cream|Compound Lidocaine Cream ,1-2 grams per person.
16119327|NCT02017379|Drug|Erythromycin|
16119328|NCT02017379|Drug|Metoclopromide|
16119329|NCT02017366|Other|Enteral feeding|Target of 1000 kCal/day enteral feeding or glucose 20%, perferably given overnight.
16119330|NCT02017353|Dietary Supplement|Curcuphyt|
16119331|NCT02017340|Drug|Nilvadipine|8mg of Nilvadipine taken once a day at lunch time for 78 weeks
16119332|NCT02017340|Drug|Placebo|8mg Placebo tablet taken once a day at lunch time for 78 weeks
16119333|NCT02017327|Drug|Monoprost|Monoprost®: Latanoprost 0.005% ophthalmic preparation is a sterile unpreserved oil-based solution for topical ophthalmic use. It is supplied in 0.30 ml single use polyethylene containers. The batch numbers and reanalysis dates will be stated in the certificate of analysis.
16119334|NCT02017327|Drug|Lumigan 0.01%|Lumigan® 0.01%: Bimatoprost eye drop solution is supplied in 3 ml multidose container.
16119335|NCT02017327|Drug|Lumigan 0.03% Unit Dose|Lumigan® 0.03% Unit Dose: Bimatoprost eye drop solution is supplied in 0.4 ml single use low density polyethylene (LDPE) containers.
16119336|NCT02017314|Drug|Morphine|
16119337|NCT02017301|Other|Nutritional assessment|Daily nutritional assessment with bioelectrical impedance vector analysis, phase angle and mid-arm muscle circumference
16119338|NCT02017275|Device|BuMA|This group will contain 1175 subjects.
16119339|NCT02017275|Device|EXCEL|This group will contain 1175 subjects.
16119340|NCT02017262|Behavioral|Self-management group|8 weekly sessions of group self-management
16119341|NCT02017262|Behavioral|Enhanced usual care|Usual care by primary care provider, plus educational pamphlet about depression, list of local mental health resources, and letter for provider advising him/her of depression diagnosis
16119343|NCT02017249|Drug|Silica and cellulose placebo powder|
16119344|NCT02017236|Drug|Volitinib|600mg Volitinib ,single dose,oral
16119345|NCT02017223|Device|Knowme Device Wear|
16119346|NCT02017197|Drug|Marevan®|Branded warfarin sodium tablets (manufacturer União Química Farmacêutica Nacional S/A, Brazil) by mouth; dose adjusted according to INR and medical judgement.
16119347|NCT02017197|Drug|generic warfarin #1|Generic warfarin sodium tablets, manufacturer (União Química Farmacêutica Nacional S/A, Brazil), by mouth; dose adjusted according to INR and medical judgement.
16119348|NCT02017197|Drug|generic warfarin #2|Generic warfarin sodium tablets, manufacturer (Laboratório Teuto Brasileiro S/A, Brazil), by mouth; dose adjusted according to INR and medical judgement.
16119349|NCT02017184|Biological|Noninvasive core temperature thermistor|
16119350|NCT02017171|Drug|Allopurinol|
16119351|NCT02017171|Drug|Placebo|Inactive oral tablets identical in appearance to allopurinol tablets.
16119352|NCT02017158|Other|Virtual Sprouts|The Virtual Sprouts intervention group will play Virtual Sprouts in a school-based implementation of the game.
16119353|NCT02017145|Drug|Chloraprep|
16119354|NCT02017132|Dietary Supplement|Pomegranate extract|
16119355|NCT02017119|Drug|Comparison between Lactulose and Lactulose-Paraffin|
16119356|NCT02017106|Procedure|Endovenous Laser ablation and concomitant phlebectomies|
16119357|NCT02017106|Procedure|Endovenous Laser ablation and sequential phlebectomies|
16119358|NCT02017093|Device|Error Enhancement|Patients underwent upper extremity robotic training with the error enhancement effect. Training have focused on hand reaching movements in varity of directions and range of motions.
16119359|NCT02017093|Device|control treatment|Patients underwent upper extremity robotic training without the error enhancement effect. Training have focused on hand reaching movements in varity of directions and range of motions.
16119360|NCT02017067|Procedure|hydraulic resistance circuit training|12 weeks (3 times per week, 40 min circuit) of hydraulic resistance circuit training that consisted of 7 types of equipments for different part of strength training.
16119361|NCT02017054|Other|Cath|No intervention - registry
16119362|NCT02017041|Device|Medsignals|MedSignals (www.medsignals.com) is a cellular communicating medication management device designed to improve adherence. It will be used to track when medication is removed from the device at dosing times and deliver audible and visual alerts at dosing times and to relay adherence data securely to patient files. Participants will use this device throughout the 5-week trial. It is a Class I device.
16119363|NCT02017041|Device|smartphone app|The smartphone app being evaluated in this study is designed to support effective medication management of opioid substitution patients taking buprenorphine/naloxone.
16119364|NCT02017015|Drug|nab-paclitaxel|nab-paclitaxel at 125 mg/m^2, by IV infusion over 30 to 40 minutes (maximum infusion time not to exceed 40 minutes)
16119365|NCT02017015|Drug|Gemcitabine|Gemcitabine at 1000 mg/m^2 IV infusion over 30 to 40 minutes given once weekly for 3 weeks (Days 1, 8 and 15) followed by a week of rest (28 day cycle).
16119366|NCT02017002|Procedure|Ivor Lewis|for the patients with lower-to mid third esophageal cancer, some surgeon performed Ivor lewis esophagectomy, which performing the esophago-gastrostomy in the chest after gastric mobilization without cervical incision wound
16119367|NCT02017002|Procedure|Tri-incision|a cervical incision was required for esophagogastrostomy after esophagectomy and gastric mobilization
16119368|NCT02016989|Device|RGTA OTR4120 (CACICOL20)|
16119369|NCT02016989|Device|physiological salt solution|
16119370|NCT02016976|Drug|EMLA Analgesic Cream|
16119371|NCT02016976|Drug|Dormicum 2.5 mg and Pethidine 25 mg|Routine anesthesia and analgesia ( Dormicum 2.5 mg and Pethidine 25 mg )normally given to patients before and during pacemaker implantation
16119372|NCT02016963|Biological|Raxibacumab|Raxibacumab will be supplied in 50 milliliter (mL) sterile, single-use vials containing 34.9 mL of liquid formulation per vial. Each vial contains 50 milligram (mg)/mL raxibacumab in 0.13 mg/mL citric acid, 2.8 mg/mL sodium citrate, 10 mg/mL sucrose, 18 mg/mL glycine, 0.2 mg/mL polysorbate 80, pH 6.5
16119377|NCT02016911|Drug|semaglutide|Once daily oral administration of semaglutide formulated with SNAC. Dose escalation, with 5 days on 5 mg followed by 5 days on 10 mg
16119378|NCT02016898|Procedure|Placement of the sponge|
16119379|NCT02016898|Drug|Mitomycin-C|
16119380|NCT02016885|Drug|glycopyrrolate, 1.0%|glycopyrrolate Topical Wipes, 1.0%
16119381|NCT02016885|Drug|glycopyrrolate, 2.0%|glycopyrrolate Topical Wipes, 2.0%
16119382|NCT02016885|Drug|glycopyrrolate, 3.0%|glycopyrrolate Topical Wipes, 3.0%
16119383|NCT02016885|Drug|glycopyrrolate, 4.0%|glycopyrrolate Topical Wipes, 4.0%
16119384|NCT02016885|Other|Vehicle|Vehicle Topical Wipes
16119385|NCT02016872|Drug|18F-FMISO|
16119386|NCT02016872|Other|PET/CT|
16119387|NCT02016859|Other|Immature Platelet Fraction|
16119388|NCT02016846|Drug|Liraglutide|
16119389|NCT02016846|Drug|Placebo|
16119390|NCT02016833|Procedure|Blood Sampling|Sampling of 80mL of whole blood
16119391|NCT02016820|Drug|Omeprazole (suspension)|1 mg/kg/day
16119392|NCT02016820|Other|Lifestyle Modification|Standard lifestyle modification: small meals, upright feeding, elevation of the head of the bed
16119438|NCT02016430|Behavioral|MeLT Dietary intervention|Mediterranean diet containing food with low TMAO content.
16119439|NCT02016430|Behavioral|TLC Dietary intervention|Standard American Heart Association (AHA) recommendations for dietary counseling
16119440|NCT02016430|Behavioral|MeLT dietary intervention with TMAO|Mediterranean diet containing food with low TMAO content with TMAO levels provided to the subject for guidance.
16119606|NCT02015195|Other|Isopropyl Alcohol (70%)|
16119393|NCT02016807|Device|ProThelial|August 2013, the FDA cleared the use of ProThelial, a polymerized high potency sucralfate paste, as a device for the management of oral mucositis.Standard potency non-polymerized sucralfate is not recommended by MASCC/ISOO for the treatment or prevention of mucositis, oral or alimentary. However high potency polymerized sucralfate has been associated with rapid amelioration and prevention of both oral and alimentary mucositis in a patient with advanced head neck cancer treated simultaneously with high dose chemo-radiation. High potency sucralfate is standard sucralfate polymerized into 'sucralfate sheets' that adhere and orderly layer upon the mucosa achieving and maintaining elevated concentrations of sucralfate long after the initial dose administration. Three hours following administration, high potency sucralfate maintains a 7 fold greater surface concentration of sucralfate on normal lining and a 23 fold greater concentration on inflamed, ulcerated mucosa.
16119394|NCT02016781|Procedure|Allogeneic Hematopoietic Cell Transplant|Bone marrow or peripheral blood stem cell transplant.from a fully matched related (6/6) or unrelated (8/8) donor. The specific transplant treatment regimen will be at the discretion of the treating physician but is required to be reduced-intensity.
16119395|NCT02016781|Procedure|Hypomethylating Therapy / Best Supportive Care|The specific non-transplant treatment regimen will be at the discretion of the treating physician.
16119396|NCT02016768|Procedure|decompressive cervical surgery|To make decompressive cervical surgery, either anterior cervical discectomy and fusion or posterior laminoplasty on the patients suffering from cervical spondylotic myelopathy and hypertension.
16119397|NCT02016755|Biological|HGF Plasmid|Intramuscular injection in the affected limb.
16119398|NCT02016742|Drug|RDC5|
16119399|NCT02016729|Drug|AMG 232|Given an an oral tablet in escalating doses.
16119400|NCT02016729|Drug|Trametinib|Trametinib is an oral tablet given in a fixed dose.
16119401|NCT02016716|Drug|Romosozumab 90 mg/mL|Administered as 2 SC injections of a 90 mg/mL concentration in a 1.17 mL crystal zenith resin prefilled syringe (PFS).
16119402|NCT02016716|Drug|Placebo 90 mg/mL|Placebo administered as 2 SC injections with the 1.17 mL crystal zenith resin PFS.
16119403|NCT02016716|Drug|Romosozumab 70 mg/mL|Administered as 3 SC injections of a 70 mg/mL concentration in a 1.0 mL glass PFS.
16119404|NCT02016716|Drug|Placebo 70 mg/mL|Placebo administered as 3 SC injections with the 1.0 mL glass PFS.
16119405|NCT02016703|Other|Erythritol drink|
16119406|NCT02016703|Other|Placebo drink|
16119407|NCT02016664|Drug|Ketamine|The St.Joseph's Heath Care Pharmacy will supply the compounded oral ketamine capsules. Patients who are going to participate in this study are already taking this oral ketamine as a part of their chronic pain medications. No new patient will start oral ketamine for the sake of this study. Two doses of oral ketamine will be used for the same patient, 10 mg and 20 mg every 8 hours. These doses are the standard doses in our clinic. Other clinics using much higher doses.
16119408|NCT02016651|Behavioral|Right side position|Enrolled infants are positioned on their back or right side. Tracheal aspirate is assessed for pepsin concentration as an index of aspiration.
16119409|NCT02016638|Other|Polysomnography and ambulatory blood pressure recording|
16119410|NCT02016625|Drug|Faldaprevir|
16119411|NCT02016625|Drug|Faldaprevir|
16119412|NCT02016625|Drug|Cyclosporine|
16119413|NCT02016625|Drug|Tacrolimus|
16119414|NCT02016612|Device|Seri Surgical Scaffold|An FDA approved Bioabsorbable mesh Seri Surgical Scaffold will be utilized in the study as an internal hammock mesh support of the breast.
16119415|NCT02016599|Other|Monitoring and biospecimen collection|The study team will use monitoring methods normally used in the NICU (physical exams, echocardiograms, and ECG) and some new monitoring methods (Near-infrared spectroscopy or NIRS) to find out all the changes that a baby's heart and lungs go through during the first week after delivery. In addition, blood samples will be taken to assess lactate, troponin, and creatinine levels.
16119416|NCT02016586|Dietary Supplement|Maternal Nutritional Supplement|S348S0
16119417|NCT02016573|Device|Renal Denervation|Renal Denervation Catheter
16119418|NCT02016560|Drug|florbetapir F 18|
16119419|NCT02016560|Drug|Flortaucipir F18|
16119420|NCT02016560|Procedure|Brain PET Scan|positron emission tomography (PET) scan of the brain
16119421|NCT02016547|Procedure|abciximab IV and thrombectomy|
16119422|NCT02016547|Drug|alteplase 0.9mg/kg (10% by IV bolus following by 90% by 1 hour IV drip)|
16119423|NCT02016534|Drug|AMG 337|AMG 337 300mg orally daily.
16119424|NCT02016521|Other|Cooling Fabric|Garment made of 100% nylon and consisting of long sleeved shirt and full trouser.
16119425|NCT02016521|Other|Placebo Garment|Garment made of 100% polyester consisting of long sleeved shirt and full trouser
16119426|NCT02016508|Drug|autologous bone marrow derived stem cells|intravitreal injection of autologous bone marrow stem cells in 0.1 ml volume
16119427|NCT02016495|Dietary Supplement|Magnesium plus alpha-lipoic acid|
16119428|NCT02016495|Drug|Placebo|
16119429|NCT02016482|Biological|Adalimumab|
16119430|NCT02016482|Other|Placebo|
16119431|NCT02016469|Other|co-transplantation of FMT and pectin|300ml Bacterial suspension (from 60g fresh stool )for fecal microbiota transplantation the first day and 20g pectin given continuously for total five days
16119432|NCT02016469|Other|single fecal microbiota transplantation|single fecal microbiota transplantation once the first day
16119433|NCT02016469|Dietary Supplement|pure give pectin 20g/d for five days|pure give pectin 20g/d for five days
16119434|NCT02016456|Device|Theta-Burst Stimulation|At 80% motor threshold determined using single pulse stimuli. Depending on the hemisphere determined by connectivity analysis and neuronavigation in each individual, either continuous (left prefrontal) or intermittent (right prefrontal) train of pulses will be delivered.
16119435|NCT02016456|Device|High frequency stimulation|Left prefrontal stimulation. 120% motor threshold with a pulse sequence of 10 Hz for 4 seconds, followed by a 26 second quiet period. Treatment will last for a total of 37.5 minutes this is a total of 3,000 pulses
16119436|NCT02016443|Drug|Tizanidine|Group Tizanidine (Group T) will receive 4 mg tizanidine per oral twice a day during the postoperative first week and the first dose will be administered 1 hour before surgery
16119437|NCT02016443|Drug|Placebo|Group Placebo (Group P) will receive a placebo per oral twice a day during the postoperative first week and the first dose will be administered 1 hour before surgery
16119441|NCT02016417|Drug|A combination of Gemcitabine and cisplatin|The GP regimen consists of gemcitabine at a dose of 1,000 mg/m2 by intravenous (i.v.) infusion over 30 min on day 1 and day 8, and cisplatin 80 mg/m2 by i.v. infusion for 4 h on day 1-3, The regime will be repeated every 3 weeks up to a total of 2-3 courses. Concurrent chemoradiotherapy is administrated with 3 cycles of weekly Cisplatin 100 mg/m2 starting on the first day of IMRT.
16119442|NCT02016417|Drug|A combination of Docetaxel, cisplatin and 5-Fluorouracil|The TPF regimen consists of docetaxel at a dose of 60 mg/m2/day on day 1, cisplatin 60 mg/m2 by i.v. infusion for 4 h on day 1-3, plus 5-Fluorouracil 600 mg/m2 CIV over 120 hours. The regime will be repeated every 3 weeks up to a total of 2-3 courses. Concurrent chemoradiotherapy is administrated with 3 cycles of weekly Cisplatin 100 mg/m2 starting on the first day of IMRT.
16119443|NCT02016404|Other|Low-sodium, high-potassium salt|Iodized low-sodium, high-potassium botcanh (a traditional mixture of salt, MSG, sugar and herbs) plus and iodized low-sodium, high-potassium salt for home food preparation
16119444|NCT02016404|Other|Regular salt|Regular iodized high-sodium botcanh (a traditional mixture of salt, MSG, sugar and herbs) and high-sodium salt
16119445|NCT02016391|Drug|Dexmedetomidine|Dexmedetomidine 0.4 µg/kg/hr infusion during RF procedure
16119446|NCT02016378|Behavioral|Bias retraining|Participants will view pictures of drug (e.g., alcohol) and non-drug stimuli (e.g., soft drinks) on a computer. Participants will then use the computer to make the drug pictures smaller and the non-drug pictures larger.
16119447|NCT02016378|Behavioral|Sham retraining|Participants will view pictures of drug and non-drug related stimuli on a computer. Participants will then use the computer to make the pictures larger or smaller based on the tilt of the picture (slightly to the left or right), but without regard to the content of the picture.
16119448|NCT02016365|Drug|Doxycycline|200 mg/day (100 mg twice daily, orally) for 4 weeks with a pause of 2 weeks in combination with UDCA
16119449|NCT02016365|Drug|Ursodeoxycholic acid|750 mg/day (500 mg +250mg orally) continuously
16119450|NCT02016352|Biological|patient CSF extraction with hydrocephalus|CSF extraction
16119451|NCT02016352|Biological|witness CSF extraction|CSF extraction from patient not suffering from hydrocephalus
16119452|NCT02016339|Behavioral|Standard care|24-h consultation telephone line to the sleep nurses to answer questions regarding CPAP usage. Patients were reviewed at 1 month and at 3 month intervals during the first year and every 6 months thereafter in the CPAP clinic by the nurse. Additional visits or phone calls by sleep specialist if doubts about a patient's compliance or willingness to continue with the therapy.
16119453|NCT02016339|Behavioral|Intensive care|Standard group care plus: Involvement of the patient's partner or family necessary. Extra education on sleep apnea and CPAP by sleep specialists via a 15-min videotape. 10- to 15-min lecture from the sleep clinic's nurses after CPAP titration study. Phone calls by nurses at 2 and 7 days. Early review of patients by sleep specialists at 15 and 30 days. Home visits by sleep nurses, if there doubts about a patients adherence
16119454|NCT02016326|Device|HD Colon|High Definition White Light
16119455|NCT02016326|Device|I-scan 1|I-Scan 1 has Contrast Enhancement(CE), Surface Enhancement(SE). SE mode highlights light-dark contrast thereby providing more mucosal surface detail. CE mode digitally adds blue to darker areas providing detailed imaging of subtle mucosal irregularities.
16119456|NCT02016326|Device|I-Scan 2|I-Scan 1 has Contrast Enhancement(CE), Surface Enhancement(SE)and Tone Enhancement(TE). SE mode highlights light-dark contrast thereby providing more mucosal surface detail. CE mode digitally adds blue to darker areas providing detailed imaging of subtle mucosal irregularities. TE provides a uniform color image and is intended for detailed inspection of distinct lesions.
16119457|NCT02016313|Other|physiotherapy|
16119458|NCT02016300|Device|Unloader Bracing|The bracing arm patients will be randomly selected and will wear an unloader brace post-operatively during the study period.
16119459|NCT02016300|Device|Non-Bracing|Microfracture performed with no post-operative unloader bracing
16119460|NCT02016287|Other|Sequential chemotherapy （paclitaxel 80mg/m2 d1,d8) and radiotherapy|Sequential paclitaxel chemotherapy and radiotherapy
16119461|NCT02016274|Other|Sequential chemotherapy (paclitaxel 175mg/m2 d1; cisplatin 37.5mg/m2 d1,d2) and radiotherapy|Sequential paclitaxel/cisplatin chemotherapy and radiotherapy
16119462|NCT02016261|Drug|Fluvoxamine|The subjects will be prescribed Fluvoxamine treatment for 24 weeks with dose 50-300 mg
16119463|NCT02016248|Radiation|Stereotactic Ablative Body Radiotherapy as Monotherapy|The prescribed planned tumor volume (PTV) dose of 36.25 Gy shall be given in 5 fractions using CyberKnife Hypofractionated Stereotactic Ablative Body Radiation Therapy. PTV will be defined per parameters outlined in the protocol and will at minimum include the entire prostate gland.
16119464|NCT02016248|Radiation|Stereotactic Ablative Body Radiotherapy as a Boost|The prescribed planned tumor volume (PTV) dose of 27.5 cGy shall be given in 5 fractions using CyberKnife Hypofractionated Stereotactic Ablative Body Radiation Therapy as a boost following 5040 cGy with external beam. PTV will be defined per parameters outlined in the protocol and will at minimum include the entire prostate gland. Hormonal therapy will given as indicated in the protocol.
16119465|NCT02016235|Drug|Phosphorus Supplement|250 mg po qid
16119466|NCT02016235|Other|Observation|Baseline blood and urine measurements only
16119467|NCT02016222|Procedure|tears sampling|
16119468|NCT02016209|Drug|nanoparticle albumin-bound paclitaxel|Neoadjuvant chemotherapy of nanoparticle albumin-bound paclitaxel in stage Ⅱ B and IIIA non-small cell lung cancer
16119469|NCT02016196|Drug|Rifaximin|"6 rifaximin caps of 200 mg morning and night, 15 days before and 6 months after TIPS
~--------------------------------------------------------------------------------"
16119470|NCT02016196|Drug|placebo|6 placebo caps per day morning and night, during 15 days before TIPS and 6 months after TIPS
16119471|NCT02016183|Drug|Candesartan cilexetil / hydrochlorothiazide|Candesartan cilexetil / hydrochlorothiazide combination tablets
16119472|NCT02016170|Drug|Ticagrelor 180mg|"After providing written informed consent, eligible patients on maintenance prasugrel meeting inclusion and exclusion criteria will be randomized in a 1:1:1 fashion to one of the following treatment arms:
~A. Ticagrelor 180 mg loading dose (two 90mg ticagrelor tablets) followed by 90 mg BID maintenance dose for 7±2 days.
~B. Ticagrelor 90 mg (one 90mg ticagrelor tablet) followed by 90 mg BID maintenance dose for 7±2 days C. Prasugrel 10 mg once daily maintenance dose for 7±2 days"
16119554|NCT02015611|Dietary Supplement|Placebo|Placebo
16119473|NCT02016170|Drug|Prasugrel 10mg|"After providing written informed consent, eligible patients on maintenance prasugrel therapy meeting inclusion and exclusion criteria will be randomized in a 1:1:1 fashion to one of the following treatment arms:
~A. Ticagrelor 180 mg loading dose (two 90mg ticagrelor tablets) followed by 90 mg BID maintenance dose for 7±2 days.
~B. Ticagrelor 90 mg (one 90mg ticagrelor tablet) followed by 90 mg BID maintenance dose for 7±2 days C. Prasugrel 10 mg once daily MD for 7±2 days"
16119474|NCT02016170|Drug|Ticagrelor 90mg|"After providing written informed consent, eligible patients on maintenance prasugrel therapy meeting inclusion and exclusion criteria will be randomized in a 1:1:1 fashion to one of the following treatment arms:
~A. Ticagrelor 180 mg loading dose (two 90mg ticagrelor tablets) followed by 90 mg BID maintenance dose for 7±2 days.
~B. Ticagrelor 90 mg (one 90mg ticagrelor tablet) followed by 90 mg BID maintenance dose for 7±2 days C. Prasugrel 10 mg once daily MD for 7±2 days"
16119475|NCT02016157|Drug|Moxifloxacin|TO ASSESS THE EFFICACY OF MOXIFLOXACIN IN SITU GEL IN THE TREATMENT OF PERIODONTAL POCKET.
16119476|NCT02016118|Device|Ialuril|The treatment is an intravesical administration of combined hyaluronic acid (HA) 1.6% and chondroitin sulphate (CS) 2.0% once per week for the first month, followed by one instillation every two weeks for the second month and one instillation per month until stable remission of the symptoms.
16119477|NCT02016105|Drug|GP2017 Adalimumab|
16119478|NCT02016105|Drug|Humira ® Adalimumab|
16119479|NCT02016079|Dietary Supplement|omega-3|200 ml fruit drink containing omega-3
16119480|NCT02016066|Drug|CR6261|CR6261 50 mg/kg solution will be administered as a single 2-hour intravenous infusion
16119481|NCT02016066|Drug|Placebo|Placebo will be administered as a single 2-hour intravenous infusion
16119482|NCT02016040|Procedure|High Intensity Focused Ultrasound|
16119483|NCT02016027|Drug|Carica folia|
16119484|NCT02016014|Device|Smartphone with APP|Smartphone with APP (EVIDENT) for 3 months
16119485|NCT02016014|Behavioral|Counseling on lifestyles|Counseling on physical activity and mediterranean diet
16119486|NCT02016001|Other|toothpaste 1 with maximum fluoride concentration|tooth paste 1 will be the tested intervention with maximum fluoride concentration (1500 ppm), which will be provided to the case group. They will brush the teeth twice daily for 2 minutes
16119487|NCT02016001|Other|toothpaste 2 with 1000 ppm of fluoride|tooth paste 2 will be the intervention with 1000ppm of fluoride, will be used by the control group. They will brush the teeth twice daily for 2 minutes
16119488|NCT02015988|Drug|Fenofibrate|
16119489|NCT02015988|Drug|Simvastatin|
16119490|NCT02015962|Drug|Intravenous potassium chloride|
16119491|NCT02015962|Drug|Oral potassium chloride|
16119492|NCT02015949|Drug|Methylphenidate|Cross-over design comparing methylphenidate 0.3 mg/kg (to nearest 5mg) twice daily to placebo
16119493|NCT02015949|Drug|Placebo|Twice daily placebo tablet for two weeks
16119494|NCT02015936|Behavioral|Six Week Physical Activity Intervention|Tailored Wii Fit prescription based on physical fitness assessments and a schedule of six home visits by an oncology RN.
16119495|NCT02015936|Other|Progress Reporting|Participants will keep a log to record the physical activities they have done with the Wii Fit during the 6-week period. Audio-recording may be included for quality control. Self-report data will be collected by Internet surveys through the University of South Florida (USF) Health Qualtrics application at baseline (T1) and at 6 weeks post-intervention (T2). The nurse will take small amount of the participant's hair (20 strands) for a hormone test during the first visit and last visit.
16119496|NCT02015923|Procedure|Colonic resection|Colonic cancer resection, R0 No surgical intervention on metastasis
16119497|NCT02015923|Drug|Chemotherapy- scheme|Chemotherapy, specified in each center with or without biological drugs
16119498|NCT02015910|Drug|Sitagliptin|Comparison of Sitagliptin a dipeptidyl-peptidase four (DPP-4) inhibitor 100mg pill with placebo comparator
16119499|NCT02015910|Drug|Placebo|Sugar pill manufactured to mimick Sitagliptin 100mg pill.
16119500|NCT02015897|Procedure|Physical TherapyA|"Group A:
~Skin care
~Manual lymphatic drainage
~Bandaging using Coban™2Lite
~Guidance on physical activity"
16119501|NCT02015897|Procedure|Physical TherapyB|"Group B:
~Skin care
~Bandaging using Coban™2Lite
~Guidance on physical activity"
16119502|NCT02015871|Drug|Degarelix|
16119503|NCT02015858|Procedure|Chest drain withdrawal|
16119504|NCT02015858|Device|Pain Monitor|
16119505|NCT02015845|Device|Accuvein|
16119506|NCT02015845|Device|Routine technique|Placement of peripheral intravenous catheters using the routine technique
16119507|NCT02015832|Device|Coronary stent|
16119508|NCT02015832|Radiation|Multi Slice Computed Tomography|A coronary non-invasive Multi Slice Computed Tomography will be performed in patients
16119509|NCT02015832|Device|instantaneous wave-free ratio|Pressure-derived, adenosine-free index on physiological assessment of stenosis severity
16119510|NCT02015832|Device|Fractional flow reserve|Pressure-derived index on physiological assessment of stenosis severity
16119511|NCT02015832|Device|Intravascular Ultrasound|Allows the application of ultrasound technology to see from inside blood vessels out through the surrounding blood column, visualizing the inner wall of blood vessels
16119517|NCT02015806|Behavioral|RxTimerCap|The RxTimerCap is a pill bottle cap with a digital timer that shows the time elapsed since the medication was last taken. Patients randomized to receive the RxTimerCap will receive a one-time mailing with one device for each of the maintenance medications they were using at the time of identification for study eligibility; additionally, patients will receive an information card explaining the device's use which includes a telephone number at which they can get additional information.
16119555|NCT02015598|Drug|Carbocysteine|carbocisteine (2×250 mg, three times daily) for 6 weeks. The tablets are provided by Baiyunshan Pharmaceutical, China. patients will interviewed after 3 weeks to check their adherence to the study regimen by collecting and counting the number of remaining tablets, record adverse events, and refill study tablets for the next 3 weeks.
16119518|NCT02015806|Behavioral|Take-N-Slide|The Take-N-Slide device is a patented strip with toggles for each day of the week which are meant to be slid after taking a medication. Each Take-N-Slide can be removed and reused for the next prescription bottle. Patients randomized to receive Take-N-Slide will receive a one-time mailing with one device for each of the maintenance medications they were using at the time of identification for study eligibility; additionally, patients will receive an information card explaining the device's use which includes a telephone number at which they can get additional information.
16119519|NCT02015806|Behavioral|Pillbox|The standard pillbox is a plastic organization box with one compartment for every day of the week. Patients randomized to receive a pillbox will receive a one-time mailing with one device for each of the maintenance medications they were using at the time of identification for study eligibility; additionally, patients will receive an information card explaining the device's use which includes a telephone number at which they can get additional information.
16119520|NCT02015793|Biological|Adalimumab|Adalimumab pre-filled syringe, administered by subcutaneous injection.
16119521|NCT02015793|Biological|Placebo for adalimumab|Placebo for adalimumab pre-filled syringe, administered by subcutaneous injection to maintain double-blind.
16119522|NCT02015780|Drug|Fasiglifam|Fasiglifam tablets
16119523|NCT02015780|Drug|Placebo|Fasiglifam placebo-matching tablets
16119524|NCT02015780|Drug|Antihyperglycemic therapy|Including any of the following alone or in combination: insulin, sulfonylurea, thiazolidinediones, glucagon-like peptide-1 (GLP-1) receptor agonists, meglitinides, alpha-glucosidase inhibitors or dipeptidyl peptidase-4 (DPP-4) inhibitors acceptable by local practice guidelines.
16119525|NCT02015754|Drug|DEBIRI|Irinotecan hydrochloride is a semisynthetic derivative of camptothecin, an alkaloid extracted from the tree Camptotheca acuminata. Irinotecan hydrochloride trihydrate is a pale yellow to yellow crystalline powder, it is mixed in DC Beads and injected in the tumor.
16119526|NCT02015754|Device|LC Bead M1|The LC Bead M1, loaded with irinotecan (DEBIRI-M1) to treat patients with hepatic metastases from colorectal cancer.
16119527|NCT02015754|Procedure|TACE|TACE a minimally invasive procedure performed to restrict a tumor's blood supply.
16119528|NCT02015741|Device|EEG monitoring with Bispectral Index and NeuroSENSE|
16119529|NCT02015741|Behavioral|Clinical observation|Patients will be observed during awake periods and during natural sleep.
16119530|NCT02015728|Device|Tumor biology testing|"Tumor biology studies will be performed in a CLIA-approved clinical pathology laboratory using standard procedures. Immunohistochemical (IHC) testing will be performed on formalin fixed tumor obtained at the time of diagnosis and/or relapse. Results will be interpreted by a qualified pediatric pathologist and will be scored on a scale of 0 to 4+ commenting on both percentage of positive cells and intensity of staining. Results will further be reported as a binary result (positive/negative). If more than one tumor specimen is available from different surgical procedures (e.g. initial diagnosis and relapse), the results from the relapse specimen will be prioritized. Results will determine kinase inhibitor treatment arm assignment which will be administered in addition to the best available combination of low-dose oral cytotoxic agents, including temozolomide and etoposide."
16119531|NCT02015728|Drug|Temozolomide|"Temozolomide combined with Etoposide is considered the best available combination of low-dose oral cytotoxic agents for patients with refractory or recurrent CNS tumors."
16119532|NCT02015728|Drug|Etoposide|"Etoposide combined with Temozolomide is considered the best available combination of low-dose oral cytotoxic agents for patients with refractory or recurrent CNS tumors."
16119533|NCT02015728|Drug|Sorafenib|Sorafenib is a broad-spectrum kinase inhibitor.
16119534|NCT02015728|Drug|Everolimus|Everolimus is an mTOR pathway inhibitor.
16119535|NCT02015728|Drug|Erlotinib|Erlotinib is a tyrosine kinase inhibitor of the ERBB family of proteins.
16119536|NCT02015728|Drug|Dasatinib|Dasatinib is a broad spectrum SRC inhibitor.
16119537|NCT02015715|Drug|RO6864018|A single oral ascending dose of RO6864018 capsules on Day 1.
16119538|NCT02015715|Drug|Placebo|A single oral dose of placebo matching RO6864018 capsules on Day 1.
16119539|NCT02015702|Other|One-on-one physician training|Physicians in the experimental arm were visited by a instructing physician at a computer while performing clinical duties who had observed others to identify best practices. Instructors watched subjects' work, looking for a specific tip that could be applied to the current work, then demonstrated the tip, and answered any questions the subject had about using or applying this new technique .
16119540|NCT02015702|Other|Usual training|Usual training included online e-modules, 12 hours of classroom time, practice in the EPIC Playground, user acceptability training classes,non-physician technical support on all of the floors, and a physician-only help line.
16119541|NCT02015689|Behavioral|Benefits to Child|CDC VIS + message emphasizing benefits to child of MMR vaccine
16119542|NCT02015689|Behavioral|Benefits to Society|CDC VIS + message emphasizing benefits to society of MMR vaccine
16119543|NCT02015689|Behavioral|Benefits to Child and Society|CDC VIS + message emphasizing benefits both to child and to society of MMR vaccine
16119544|NCT02015689|Behavioral|CDC VIS|CDC Vaccine Information Statement (VIS)
16119545|NCT02015676|Drug|trastuzumab|Initial loading does of 4 mg/kg IV, followed by 2 mg/kg IV weekly, until disease progression
16119546|NCT02015676|Drug|paclitaxel|60 mg/m^2 IV weekly; dose increased to 70 mg/m^2, and subsequently 80 mg/m^2, after 2 treatment cycles with no evidence of DLT until disease progression
16119547|NCT02015676|Drug|Myocet|40 mg/m^2 IV weekly; dose increased to 50 mg/m^2 IV after 2 treatment cycles with no evidence of DLT for 6 cycles
16119548|NCT02015663|Drug|Tobramycin Inhalation Powder|Tobramycin Inhalation Powder 112 mg (four 28-mg capsules) taken via inhaler once or twice a day, depending on study arm
16119549|NCT02015650|Drug|Cetuximab|Patients in treatment group A will receive Cetuximab at a loading dose of 400 mg/m2 (administered over 120 minutes) and weekly maintenance doses of 250 mg/m2 (administered over 60 minutes) in combination with radiation therapy.
16119550|NCT02015650|Drug|Mitomycin-C/ 5-Fluorouracil|Patients in treatment group B will receive 7 weeks of radiation therapy concomitant with Mitomycin-C 10mg/m² (max. 15mg/m²) d 8 and d 43 and 5-Fluorouracil 1000mg/m²/24h (max. 1500mg/m²/24h) d 8 - 12 and d 43 - 47. Radiation therapy will begin on day 8.
16119551|NCT02015637|Drug|Delafloxacin|single dose
16119552|NCT02015637|Drug|Ceftriaxone|single dose
16119553|NCT02015611|Dietary Supplement|Vitamin D|2,000 IU/ day of Vitamin D3
16119556|NCT02015598|Device|Continuous Positive Airway Pressure|Patients will interviewed after 3 weeks and the end of trial.We will check their compliance to device memory download , record adverse events and pressure .
16119557|NCT02015585|Procedure|interocclusal appliance|Patients will be submitted to the treatment with interocclusal appliances 30 days before the replacement of their complete dentures.
16119558|NCT02015585|Procedure|Relining of the complete dentures|Patients will be submitted to the relining of their old dentures 30 days before the replacement of their complete dentures.
16119559|NCT02015585|Procedure|Complete denture rehabilitation|All patients will be rehabilitated with new complete dentures in the study
16119560|NCT02015572|Behavioral|Occupational intervention|Early coordinated occupational intervention and supervision in physically activities by a physiotherapist.
16119561|NCT02015572|Other|Usual care|Intervention from physiotherapist, chiropractor, rheumatologist coordinated by the patient's general physician
16119562|NCT02015559|Drug|mucoadhesive oral wound rinse|Given PO
16119563|NCT02015559|Other|laboratory biomarker analysis|Correlative studies
16119564|NCT02015546|Drug|Vilazodone|All subjects will receive Vilazodone at 10, 20 or 40mg.
16119565|NCT02015533|Drug|CR8020|CR8020 50 mg/kg solution will be administered as a single 2-hour intravenous infusion.
16119566|NCT02015533|Drug|Placebo|Placebo will be administered as a single 2-hour intravenous infusion.
16119567|NCT02015520|Drug|Clazakizumab|
16119568|NCT02015520|Drug|Placebo (Matching with Clazakizumab)|
16119569|NCT02015507|Drug|ivacaftor|
16119570|NCT02015507|Drug|VX-661|
16119571|NCT02015507|Drug|ciprofloxacin|
16119572|NCT02015494|Biological|VAX2012Q|Recombinant influenza HA vaccine delivered IM
16119573|NCT02015481|Drug|Cabaletta|
16119574|NCT02015468|Other|Early mobilization|Early weightbearing and physiotherapy
16119575|NCT02015468|Other|Late mobilization|Late mobilization, none-weightbearing and home exercises
16119576|NCT02015455|Other|Epidemiologic benchmarks included in lumbar imaging reports|Epidemiologic benchmarks inserted into lumbar imaging reports
16119577|NCT02015442|Dietary Supplement|Sucrose|
16119578|NCT02015429|Dietary Supplement|Pasta meal with added fractions or control with no fractions|
16119579|NCT02015416|Biological|IDC-G305|NY-ESO-1 recombinant protein together with GLA-SE
16119580|NCT02015403|Drug|Standard Care + NAC (N -ACETYLCYSTEINE)|
16119581|NCT02015403|Drug|Standard Care (in control arm)|
16119582|NCT02015390|Procedure|Autogenous RIA bone grafting|After aseptic defect and adequate soft tissue coverage have been achieved, the defect reconstruction technique will include autogenous bone grafting harvesting using Reamer-Irrigator-Aspirator (RIA) and packing it within the defect.
16119583|NCT02015390|Procedure|Allogeneic bone grafting|After aseptic defect and adequate soft tissue coverage have been achieved, the defect reconstruction technique will include defect packing with allogeneic bone graft croutons combined with demineralized bone matrix (DBM).
16119584|NCT02015377|Other|High sugar versus low sugar meals|Participants visit our lab for two 8-hour periods with a minimum of two weeks washout in between. In one visit they receive high sugar low fiber meals, in the other they receive low sugar, high fiber meals. The order of meals is randomized
16119585|NCT02015364|Procedure|Controlled early mobilization|1. The intervention group: Must perform controlled mobilization-exercises from the beginning of week 3 - 8.
16119586|NCT02015351|Drug|bevacizumab|Injection technique: After lid speculum insertion and irrigation of the conjunctiva with 5% povidone-iodine, 0,05ml of bevacizumab will be inserted through the pars plana 3.5mm to 4.0mm posterior to the surgical limbus using a 30 gauge needle. After injection, topical antibiotics will be immediately applied in the injected eye. Immunosuppression: Corticosteroids will be prescribed (1mg/Kg/d) with tapering along 5 months. Immunosuppressive drug of choice is cyclosporine (3-5mg/Kg/d). In case of contraindication to cyclosporine use, azathioprine or mycophenolate mofetil will be prescribed.
16119587|NCT02015325|Behavioral|Planet Water Foundation's Program|Planet Water Foundation's Program (PWP) provides a school-based program with an aim to improve health outcomes in children using three components: (a) access to safe water, (b) access to hand washing facilities, and (c) access to water-health and hygiene education. As part of the PWP, access to safe water is provided through the use of an AquaTower, which incorporates an Ultra Filtration (UF) system. WASH messaging is also posted around the AquaTower as derived from PWP's school-based four week Water-Health & Hygiene education program.
16119588|NCT02015312|Drug|Epigallocatechin-3-gallate (EGCG)|"Pharmaceutical formulation: capsules
~Dose:
~400 mg/d for 3 months; 800 mg/d for 3 months, 1200 mg/d for 6 months Route of administration: p.o. Treatment duration: 12 months"
16119589|NCT02015312|Drug|Placebo|"Pharmaceutical formulation: capsules
~Dose:
~400 mg/d for 3 months; 800 mg/d for 3 months, 1200 mg/d for 6 months Route of administration: p.o. Treatment duration: 12 months"
16119590|NCT02015299|Drug|Linagliptin|one tablet linagliptin 5 mg/day for 26 weeks
16119591|NCT02015299|Drug|placebo|one tablet matching placebo/day for 26 weeks
16119592|NCT02015286|Device|easypod™|Saizen® (Somatropin) as per Summary of Product Characteristics administered by easypod™
16119593|NCT02015273|Device|easypod™|Saizen® (Somatropin) as per Summary of Product Characteristics administered by easypod™
16119594|NCT02015260|Drug|Topical NO|Varying doses of sodium nitrite and citric acid co-applied to warts
16119595|NCT02015260|Drug|Placebo|Placebo
16119596|NCT02015247|Procedure|computer-assisted surgery|use of computer-assisted navigation during periacetabular osteotomy
16119597|NCT02015234|Drug|TNX-102 SL|TNX-102 SL 2.8 mg taken daily at bedtime.
16119598|NCT02015221|Device|Dual Action Pneumatic Compression Device|A novel dual action pneumatic compression device that provides both sustained compression while ambulatory, and intermittent pneumatic compression when connected to an AC outlet.
16119599|NCT02015221|Device|Standard Compression Garments|Compression stockings with a 30-40mmHg level of compression.
16119600|NCT02015208|Drug|Ruxolitinib|20 mg orally on day 1 to 21 of each 28 day cycle. Number of Cycles: 7 or until progression or unacceptable toxicity develops.
16119601|NCT02015195|Other|Acetic Acid (5%)|
16119602|NCT02015195|Other|Sodium Bicarbonate Slurry (50%)|
16119603|NCT02015195|Other|Papain Slurry (70%)|
16119604|NCT02015195|Other|Ammonia (10%)|
16119605|NCT02015195|Drug|Lidocaine (4%)|
16119607|NCT02015195|Other|Hot Tap Water (40 degrees Celsius)|
16119608|NCT02015195|Other|No treatment|
16119609|NCT02015182|Other|Blood sample for bupivicaine pharmacokinetics|"Bupivacaine levels will be measured with an assay developed on the 4000 QTrap Tandem Mass Spectrometer (Applied Biosystems/ MDS Sciex).
~Data will be collected and analyzed using the Agilent ChemStation software (Rev A.10.02). The analytical column is an Agilent Zorbax Eclipse XDB-C8 (4.6 x 150mm, 5µm).Quantification of bupivacaine is based on analyzing a six point calibration curve (0 to 4.0 mg/L). An internal standard (Prilocaine 221.2/86.1) is included with each calibrator, quality control or patient sample. Instrumentation and Chromatographic conditions: The HPLC system consists of a Specta-System P1000 Isocratic Pump and an AS3000 Autosampler (Thermo Electron Corporation, Waltham MA)."
16119610|NCT02015169|Drug|Lapatinib|lapatinib 1250mg qd daily up to 8 cycles (3 weeks * 8 cycles = 24 weeks)
16119611|NCT02015156|Biological|PF-05280014|Concentrate for solution for infusion, sterile vial 150 mg, single-dose 6 mg/kg administered as 90-minute infusion on Day 1
16119612|NCT02015156|Biological|Herceptin®|Concentrate for solution for infusion, sterile vial 440 mg, single-dose 6 mg/kg administered as 90-minute infusion on Day 1
16119613|NCT02015130|Other|Individual treatment|See detailed description
16119614|NCT02015117|Other|Laboratory Biomarker Analysis|Correlative studies
16119615|NCT02015117|Other|Pharmacological Study|Correlative studies
16119616|NCT02015117|Procedure|Therapeutic Conventional Surgery|Undergo surgical resection of the tumor
16119617|NCT02015117|Drug|Trametinib|Given PO
16119618|NCT02015117|Radiation|Whole-Brain Radiotherapy|Undergo whole-brain radiation therapy
16119619|NCT02015104|Biological|BCG intravesical live (TICE Bacillus Calmette-Guerin (BCG))|TICE BCG for intravesical use, is an attenuated, live culture preparation of the Bacillus of Calmette and Guerin (BCG) strain of Mycobacterium bovis
16119620|NCT02015104|Biological|PANVAC|A recombinant virus vector vaccine containing genes for human carcinoembryonic antigen (CEA), mucin-1 (MUC-1) and three co-stimulatory molecules (designated Triad of costimulatory molecules (TRICOM): B7.1, intercellular adhesion molecule-1 (ICAM-1), and leukocyte function-associated antigen-3 (LFA-3).
16119621|NCT02015091|Biological|PfSPZ Vaccine|The PfSPZ Vaccine is composed of radiation-attenuated Plasmodium falciparum sporozoites (PfSPZ) and is designed to prevent malaria in adults, children, and infants. It is formulated in phosphate buffered saline (PBS) with 1% human serum albumin (HSA). Sanaria Incorporated (Sanaria), Rockville, Maryland, developed and produced the PfSPZ Vaccine.
16119622|NCT02015065|Drug|Vandetanib|Vandetanib administered orally once per day continuously using a 28 day cycle until disease progression or unacceptable toxicity
16119623|NCT02015039|Drug|BoNT Injections|
16119624|NCT02015039|Procedure|Occupational Therapy|
16119627|NCT02015000|Procedure|P.E.R.F.A.M.T|Surgical Result of Primary and Recurrent Pterygium by Using Pterygium Extended Removal followed by Fibrin Glue Assisted Amniotic Membrane Transplantation (P.E.R.F.A.M.T)
16119628|NCT02014987|Behavioral|Training programmes|"Runners with a high body mass index follow two types of training programmes:
~a running programme of 3 kilometres per week
~a running programme 6 kilometres per week
~The amount of running will be increased with 10 % per week."
16119629|NCT02014961|Procedure|Dermal biopsy|Skin biopsy
16119630|NCT02014961|Behavioral|Gastro-intestinal questionnaire|Pagi-Sym, Bristol Stool Chart, gastrointestinal symptom rating scale (GSRS)
16119631|NCT02014961|Genetic|Whole-exome sequencing|Whole-exome sequencing (WES)
16119632|NCT02014948|Other|Exercises|The individuals who make up this group performed exercises for 10 consecutive sessions.
16119633|NCT02014935|Other|Low intensity laser|"The study wants to evaluate the use of low intensity laser on the spastic muscle.
~Want to assess whether the Low level laser prove change in muscle performace of the individual but also alters muscle activity and blood lactate."
16119634|NCT02014922|Drug|TheraTears® Lubricant Eye Drop|
16119635|NCT02014922|Drug|TheraTears® preservative-free single-use containers|
16119636|NCT02014922|Dietary Supplement|TheraTears® Nutrition|
16119637|NCT02014922|Other|TheraTears® TheraLid® Eyelid Cleanser|
16119638|NCT02014909|Biological|KTN3379|Single agent KTN3379 or in combination administered until unacceptable toxicity or progressive disease
16119639|NCT02014896|Other|Biomarker blood draw|Comparison of gene expression profiles using RNA isolated from whole blood.
16119640|NCT02014883|Drug|GLUT1 DS|
16119641|NCT02014870|Other|1:1000 Live wild-type A/California/H1N1 2009|1:1000 dilution of neat virus
16119642|NCT02014870|Other|1:100 Live wild-type A/California/H1N1 2009|1:100 dilution of neat virus
16119643|NCT02014870|Other|1:10 Live wild-type A/California/H1N1 2009|1:10 dilution of neat virus
16119644|NCT02014857|Procedure|Gingival Crevicular Fluid Sampling|
16119645|NCT02014844|Drug|aldoxorubicin|
16119646|NCT02014831|Drug|Cetuximab|"Cetuximab treatment will be administered on specific days within a 21-days-cycle and for a maximum of 6 cycles as follow :
~CETUXIMAB I.V infusion of 400 mg/m2 on cycle 1 Day 0 for 2 hours, then 250 mg/m2 for subsequent infusions for 1 hour on Day 8, Day 15 and next cycles Day1, Day8, Day15.
~In case of documented toxicities, 2 drugs doses reductions are allowed according specific algorithms indicated in protocol"
16119647|NCT02014831|Drug|TIP|"The TIP combination of treatments will be administered on specific days within a 21-days-cycle and for a maximum of 6 cycles as follow :
~PACLITAXEL I.V infusion of 175 mg/m2, for 3 hours, on Day 1 of the cycle.
~IFOSFAMIDE I.V infusion of 1200 mg/m2, for 2 hours, on Day 1, Day 2, Day 3 of the cycle.
~CISPLATINE I.V infusion of 25 mg/m2, for 1 hour, on Day 1, Day 2, Day 3.
~In case of documented toxicities, 2 drugs doses reductions are allowed according specific algorithms indicated in protocol"
16119648|NCT02014818|Device|CoCr-EES|
16119649|NCT02014805|Radiation|radiotherapy|postoperative conformal radiotherapy for Masaoka stage II-III B type thymoma
16119650|NCT02014779|Behavioral|eChange|A web-based relapse intervention program consisting of 14 modules. The patient will have access to therapist support through a secure messaging system
16119651|NCT02014779|Behavioral|Face-to-face therapy|Face-to-face psychotherapy, consisting of 20 sessions. The content will be different for different therapists, but all have an evidence based approach to therapy
16119652|NCT02014766|Procedure|Interscalene block|Ultrasound-guided interscalene block is performed.
16119653|NCT02014766|Procedure|Supraclavicular block|Ultrasound-guided supraclavicular block is performed
16119654|NCT02014753|Device|cobalt-chromium everolimus-eluting stent (CoCr-EES)|
16119655|NCT02014740|Drug|Liraglutide|Liraglutide (Victoza) is an acylated analogue of glucagon-like peptide-1 (GLP-1) indicated for the treatment of type 2 diabetes mellitus• L-group will be started and dose-escalated to 1.8mg sc once daily according to below schedule: Liraglutide will be administered with a starting dose of 0.6 mg (after a least one week) and subsequent increments to 1.2 mg (after a least one week) and to 1.8 mg (after at least a week on 1.2 mg). L-group subjects will need to achieve the final dose of 1.8 mg by at least three weeks from the starting dose. Subjects who would not be able to achieve the dose of 1.8 mg (due to potential side effects) will be advised to lower the dose to 1.2 mg. Metformin regimen will be continued. .
16119656|NCT02014740|Drug|Metformin|
16119657|NCT02014727|Biological|Group A1 : 50µg AMA1-DiCo + Alhydrogel|
16119658|NCT02014727|Biological|Group A2 : 50 µg AMA1-DiCo+ GLA-SE|
16119659|NCT02014727|Biological|Group B2 : Placebo|
16119660|NCT02014714|Drug|Morphine|Drug: Morphine Depending on the randomization schedule, 0.1mg of morphine or will be added to the intrathecal mixture.
16119661|NCT02014714|Drug|Fentanyl|Drug: Fentanyl 40mcg Depending on the randomization schedule, 40μg of fentanyl will be added to the intrathecal mixture.
16119662|NCT02014701|Procedure|Echocardiogram|"Contrast echocardiography with Optison for assessment of regional wall motion. This will be performed immediately following the resting echocardiogram by a sonographer specifically trained in myocardial contrast echocardiography.
~Contrast echocardiogram with Optison for assessment of myocardial perfusion. This will be performed using a continuous infusion of Optison using low mechanical index power-modulation imaging of the myocardium and blood pool. Myocardial perfusion will be assessed offline using video intensity analysis software."
16119663|NCT02014675|Device|SD01 ICD lead|
16119664|NCT02014662|Other|Eccentric exercise|Each subject will perform eccentric exercise against a predefined personal maximal strength of their non-dominant leg on day 1. Changes on strength, biomarker concentrations and muscle protein synthesis during damage and recovery will be measured over 22 days.
16119665|NCT02014649|Drug|20 mg laninamivir octanoate|
16119666|NCT02014649|Drug|Placebo|
16119667|NCT02014649|Drug|40 mg laninamivir octanoate|
16119668|NCT02014636|Drug|Pazopanib|Pazopanib is an orally administered 200 mg tablet available in the dose range of 400 to 800 mg
16119669|NCT02014636|Drug|MK-3475|MK 3475 is an intravenously administered 100 mg/ 4mL solution available in the potential dose range of 1 to 10 mg/kg.
16119670|NCT02014623|Other|Grass pollen sublingual immunotherapy tablet|
16119671|NCT02014623|Drug|Control|
16119672|NCT02014597|Device|HOCD|feasibility of HOCD and comparison of HOCD results between subjects with and without glaucoma
16119673|NCT02014584|Drug|Dutasteride|Dutasteride will be supplied as soft gelatin capsules, containing 0.5 mg of dutasteride to be administered orally.
16119674|NCT02014584|Drug|Placebo|Dutasteride matching placebo will be supplied as capsules to be administered orally.
16119675|NCT02014571|Drug|GSK2878175|Round tablets (5.0mg) given once daily repeated (to 2 days), oral dose.
16119676|NCT02014571|Drug|Placebo|Round tablets (5.0mg) given once daily repeated (to 2 days), oral dose visually matching GSK2878175.
16119677|NCT02014558|Drug|Gilteritinib|Participants received gilteritinib oral tablets (10 mg, 40 mg or 100 mg, depending on the dose) once daily without food allowed for at least 2 hours before and 1 hour after dosing starting from day -2 and day of cycle 1, for continuous 28-day cycles.
16119678|NCT02014558|Drug|Voriconazole|Participants received 200 mg voriconazole tablets daily every 12 hours starting from day 16 of cycle 1 through day 1 of cycle 2.
16119679|NCT02014558|Drug|Midazolam|Participants received a single oral dose of 2 mg of midazolam syrup on day -1 and day 15 of cycle 1.
16119680|NCT02014558|Drug|Cephalexin|Participants received a single oral dose of 500 mg cephalexin tablet or capsule on day -1 and day 15 of cycle 1.
16119681|NCT02014545|Drug|Lucanthone|The dose of lucanthone to be administered will be calculated based on the patient's body weight. The dose to be given will be 250 bid, 250 tid or 375 tid dependent upon study progression.
16119682|NCT02014545|Other|Placebo|Only standard treatment of whole brain radiation therapy is done.
16119683|NCT02014532|Drug|Montelukast|Patients in Montelukast Group were treated with scaling and root planing (SRP) along with Montelukast (Montair 10mg), 1 tablet twice daily for 3 weeks.
16119684|NCT02014532|Drug|Placebo|Patients in Placebo Group were treated with scaling and root planing (SRP) along with Placebo therapy, 1 tablet twice daily for 3 weeks.
16119685|NCT02014519|Procedure|Blood sampling|A blood sample (2.5 mL) will be collected from all subjects
16119686|NCT02014519|Other|Data collection|Active questioning
16119687|NCT02014506|Drug|Fludarabine|40mg/M2 once daily IV on days -7 to -2
16119688|NCT02014506|Drug|Cyclophosphamide|50 mg/kg IV on day -3 and -2
16119689|NCT02014506|Biological|anti-thymocyte globulin|
16119690|NCT02014506|Biological|filgrastim|Beginning on day 4 and continuing until blood counts recover
16119691|NCT02014506|Radiation|Total body irradiation|200 cGy per day on D-6 to -4 (eligible disease except aplastic anemia) 200 cGy per day on D-5 & -4 (severe aplastic anemia)
16119692|NCT02014506|Procedure|TCRαβ-depleted hematopoietic cell transplantation|
16119693|NCT02014506|Device|CliniMACS|Immunogenetic depletion of TCRαβ cells
16119694|NCT02014493|Procedure|High Flow Nasal Cannulae (HFNC)|HFNC 6 l/pr.min
16119695|NCT02014493|Procedure|Continuous Positive Airway Pressure (CPAP)|CPAP 6 l/pr.min
16119696|NCT02014480|Device|Umeclidinium 62.5 mcg|Umeclidinium 62.5 mcg once daily in the morning via NDPI.
16119697|NCT02014480|Device|Vilanterol 25 mcg|Vilanterol 25 mcg once daily in the morning via NDPI.
16119698|NCT02014480|Device|Umeclidinium/Vilanterol 62.5/25 mcg|Umeclidinium/Vilanterol 62.5/25 mcg once daily in the morning via NDPI.
16119699|NCT02014467|Drug|Denosumab|Injection
16119700|NCT02014467|Drug|Placebo|Injection
16119701|NCT02014467|Dietary Supplement|Elemental Calcium|Oral, at least 600 mg
16119702|NCT02014467|Dietary Supplement|Vitamin D|Oral, at least 400 IU
16119703|NCT02014454|Drug|Propranolol eye drops|"All the enrolled preterm newborns will receive propranolol as ophthalmic solution (0,1%): 3 microdrops of 6 microliters (μL) propranolol solution (= 6 μg propranolol/microdrop) will be topically applied with a calibrated pipette, in each eye, three times daily (every 8 hours).The treatment will continue until the complete development of retinal vascularisation, but no more than 60 days.
~The propranolol treatment will be always associated to the conventional approach adopted by the ETROP Cooperative Group."
16119704|NCT02014441|Drug|Talimogene laherparepvec|Talimogene laherparepvec will be administered by intralesion injection at an initial dose of up to 4.0 mL of 10^6 PFU/mL. The second and subsequent doses will will be up to 4.0 mL 10^8 PFU/mL. The second dose should be administered 21 days from the initial dose. All subsequent doses should be given every 14 days.
16119705|NCT02014428|Dietary Supplement|Hyaluronic acid|
16119706|NCT02014428|Drug|Placebo|
16119707|NCT02014415|Procedure|Liver Biopsy (Biopsy Group Only)|A percutaneous (needle) liver biopsy will be performed on subjects in the Liver Biopsy Group, in Year 1 and Year 5 of the study.
16119708|NCT02014402|Biological|Human thrombin|Thrombin purified from human plasma reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
16119709|NCT02014402|Biological|Bovine thrombin|Thrombin of bovine origin reconstituted as a 1000 IU/mL solution in blinded syringes and applied using Gelfoam® sponges
16119710|NCT02014376|Drug|SD-101 dermal cream (3%)|SD-101 is a white, crystalline powder that is formulated within an odorless, soft, white cream base. SD-101-3.0 cream contains allantoin, a diureide glyoxylic acid, at a concentration of 3% and other excipients.
16119711|NCT02014376|Drug|SD-101 Dermal Cream (6%)|SD-101 is a white, crystalline powder that is formulated within an odorless, soft, white cream base. SD-101-6.0 cream contains allantoin, a diureide glyoxylic acid, at a concentration of 6% and other excipients.
16119712|NCT02014376|Drug|Vehicle (SD-101 0%)|A white, crystalline powder that is formulated within an odorless, soft, white cream base. It contains no allantoin, only excipients.
16119713|NCT02014363|Drug|ETS6103 (low dose)|
16119714|NCT02014363|Drug|ETS6103 (high dose)|
16119715|NCT02014363|Drug|Amitriptyline|
16119716|NCT02014350|Device|DePuy Delta Xtend Reverse TSA|
16119717|NCT02014337|Drug|Mifepristone and Eribulin in combination|Single Arm, Two Parts Part 1: Dose Escalation Phase to determine MTD and RP2D in up to 20 patients Part 2: Dose Expansion Phase at RP2D in 20 patients
16119718|NCT02014324|Procedure|Endosonography|"Complete endosonographic mediastinal staging is performed in 2 steps:
~Systematic EBUS (airways)
~Systematic EUS-B (esophagus)"
16119719|NCT02014311|Procedure|CTA+CTP guided treatment strategy|CTA+CTP guided treatment strategy
16119720|NCT02014311|Procedure|CTA guided treatment strategy|CTA guided treatment strategy
16119721|NCT02014298|Radiation|non-ablative fractional laser|3 treatments with 4-6 weeks interval
16119722|NCT02014298|Other|control|observation, comparison to laser-treated area
16119723|NCT02014285|Procedure|Muscle Ultrasound and Muscle Sample|The muscles to undergo ultrasound will include the biceps brachii, wrist extensors, quadriceps, and tibialis anterior. A muscle sample will be taken from the rectus femoris.
16119724|NCT02014272|Drug|RIN 150|Each subject will receive a single oral dose of 4 fixed dose combination tablets (RIN 150) each contains 150 rifampicin and 75 mg isoniazid.
16119725|NCT02014272|Drug|reference drugs|Each subject will receive a single oral dose of 4 x 150 mg rifampicin capsules and 3 x 100 mg isoniazid capsules.
16119726|NCT02014259|Drug|semaglutide|Once daily oral administration of semaglutide formulated with SNAC. Dose escalation, with 5 days on 5 mg followed by 5 days on 10 mg
16119727|NCT02014233|Dietary Supplement|Omega-3|
16119728|NCT02014233|Dietary Supplement|Olive oil|
16119729|NCT02014220|Other|dietary treatment|
16119730|NCT02014207|Other|dietary treatment|
16119731|NCT02014194|Behavioral|attentional bias modification treatment|The attentional bias modification treatment is a behavioral computerized program (software e-prime)
16119732|NCT02014181|Dietary Supplement|finely ground flaxseed powder|40 grams finely ground flaxseed powder daily for one month to patients with cystic fibrosis
16119733|NCT02014168|Biological|Viroflu® and MVA-NP+M1|"2013-2014 season Viroflu, manufactured by Crucell. Contains 15 microgrammes of haemagglutinin (HA) from an H1N1 subtype influenza A virus, an H3N2 subtype influenza A virus and an influenza B virus per 0.5 ml dose.
~MVA-NP+M1 manufactured by by IDT Biologika GmbH, Germany. Each vial of MVA-NP+M1 contains 700 microlitres volume at a concentration of 1.3 x108 pfu/ml in 10mM Tris buffer. The dose of MVA-NP+M1 to be used in this study will be 1.5 x108 pfu."
16119734|NCT02014168|Biological|Viroflu® and saline placebo|"2013-2014 season Viroflu, manufactured by Crucell. Contains 15 microgrammes of haemagglutinin (HA) from an H1N1 subtype influenza A virus, an H3N2 subtype influenza A virus and an influenza B virus per 0.5 ml dose.
~0.9% saline placebo."
16119735|NCT02014155|Other|Inspiratory Muscle Training|Will be held inspiratory muscle training associated with a pulmonary rehabilitation program. The inspiratory muscle training is performed with a load of 40 to 50% of the muscle strength of the subjects.
16119736|NCT02014155|Other|Pulmonary Rehabilitation|Pulmonary Rehabilitation consists of isotonic exercises of upper and lower limbs, 20-minute workout on cycle ergometer in standard deflation (expiration at the time of muscle contraction), is performed three times a week for eight weeks.
16119737|NCT02014142|Drug|Latanoprost Punctal Plug Delivery System (L-PPDS)|Latanoprost Punctal Plug Delivery System (L-PPDS)
16119738|NCT02014129|Drug|LY2835219|Administered orally
16119739|NCT02014116|Drug|LY3009120 capsule|Administered orally.
16119740|NCT02014103|Drug|Tacrolimus|Administration of each formulation will be determined by sequence.
16119741|NCT02014090|Other|Hemodynamic and biological measurements|by MCE, PWA, Doppler, Multiplex, FACS
16119742|NCT02014077|Procedure|VATS ( Video-Assisted Thoracoscopy )|the patients were randomized to a Video-Assisted thoracoscopy( VATS )for retained haemothorax
16119743|NCT02014077|Procedure|Thoracostomy Tube reinsertion|the patient is randomized to reinsertion of a Thoracostomy Tube for retained haemothorax
16119785|NCT02013700|Biological|Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs)|
16119786|NCT02013700|Biological|matched placebo|The placebo will be 25 ml of Plasma-Lyte A with 1% HSA in a Cryostore bag.
16119787|NCT02013687|Biological|Pfs25 VLP- FhCMB|
16119744|NCT02014064|Drug|Atomoxetine|"MA Group: Dispense 1 cap @ 8 AM on Treatment day 9 and 10 (total daily dose 40mg or 0); 1 cap SID @ 8 AM and 4 PM on day 11,12, and 13 (total daily dose 80mg or 0); 1 cap @ 8 AM on day 14 (total daily dose, 40mg or 0).
~Control Group Schedule:
~Day 1: 40mg @ 8:00am
~Day 2: 40mg @ 8:00am
~Day 3: 40mg @ 8:00am, 40mg @ 8:00pm
~Day 4: 40mg @ 8:00am, 40mg @ 8:00pm
~Day 5: 40mg @ 8:00am, 40mg @ 8:00pm
~Day 6: 40mg @ 8:00am = Testing day (fMRI scan & cognitive testing session)"
16119745|NCT02014064|Other|Placebo|Control Group: Day 1: 40mg @ 8am Day 2: 40mg @ 8am Day 3: 40mg @ 8am, 40mg @ 8pm Day 4: 40 mg @ 8am, 40mg @ 8pm Day 5: 40mg @ 8am, 40 mg @ 8pm Day 6: 40 mg @ 8am = Testing day (fMRI scan & cognitive testing session)
16119746|NCT02014051|Drug|SyB C-1101|"SyB C-1101（rigosertib sodium） will be administered to two cohorts at either 280 mg/day or 560 mg/day.
~The dose will be administered orally twice daily for 14 consecutive days, followed by 7-day observation period. The treatment period of 21 days (14 days of administration + 7 days of observation) constitutes 1 cycle.
~The study will involve treatment through the second cycle, but treatment can be continued for 3 or more cycles if conditions for continued administration are satisfied. However, treatment will be limited to a maximum of 6 cycles including the first cycle."
16119747|NCT02014025|Procedure|Open hepatectomy|We let the 45 patients who are meet the inclusion criteria .Hospital in hepatobiliary surgery A and D district is Group A ,they will accept Open Hepatectomy: tumors are totally resected by conventional laparotomy.
16119748|NCT02014025|Procedure|Laparoscope hepatectomy|We let the 45 patients who are meet the inclusion criteria .Hospital in hepatobiliary surgery E district is Group B ,they will accept Laparoscopic Hepatectomy: tumors are totally resected through laparoscopic.
16119749|NCT02013999|Other|Virtual reality program for upper extremity rehabilitation|
16119750|NCT02013999|Other|standard occupational therapy|
16119751|NCT02013986|Drug|etomidate|0.3mg/kg IV only once during induction of general anesthesia
16119752|NCT02013986|Drug|midazolam|midazolam 0.1mg/kg IV only once before using of etomidate/propofol during induction of general anesthesia
16119753|NCT02013986|Drug|propofol|2mg/kg IV only once during induction of general anesthesia
16119754|NCT02013973|Other|AMH-analysis|At the first visit to the IVF-clinic a blood sample for serum-AMH is taken and frozen for later analysis in the AMH-group. The AMH assay used is the Beckman Coulter AMH Gene II assay. The analysis result will be added to the algorthm deciding what starting gonadotropin dose the patient is having.
16119755|NCT02013960|Drug|Cytotec|Cytotec medication compared with cytotec and laminaria
16119756|NCT02013947|Other|2 weeks of exercise in low and moderate altitude|"Group A will spend 2 weeks at an altitude of 1900m and participants absolve a training program (3h, 4x a week, total training time 24h, training intensity 55-65% of maximal heart rate).
~Group B will spend spend 2 weeks at an altitude of 400m and participants absolve a training program (3h, 4x a week, total training time 24h, training intensity 55-65% of maximal heart rate)."
16119757|NCT02013934|Dietary Supplement|Probiotic|
16119758|NCT02013934|Dietary Supplement|Placebo|
16119759|NCT02013921|Other|Physical activity|
16119760|NCT02013908|Procedure|Acupuncture plus standard ED management|
16119761|NCT02013908|Procedure|Standard ED management alone|
16119762|NCT02013895|Device|99mTc-GSA|
16119763|NCT02013882|Procedure|1-1-12 wash-in|wash-in phase during start of low flow anesthesia
16119764|NCT02013869|Device|Flow-I|Desflurane Dialed setting 18 %
16119765|NCT02013869|Device|Asys|Desflurane dialed 18%
16119766|NCT02013856|Dietary Supplement|Low Epicatechin and procyanidin|70 mg epicatechin and 65 mg procyanidins once daily for 28 days
16119767|NCT02013856|Dietary Supplement|High Epicatechin and procyanidin|140 mg epicatechin and 130 mg procyanidins once daily for 28 days
16119768|NCT02013856|Dietary Supplement|High procyanidin|No epicatechin and 130 mg procyanidins once daily for 28 days
16119769|NCT02013856|Dietary Supplement|Placebo|Placebo control once daily for 28 days
16119770|NCT02013843|Behavioral|Community-based treatment of overweight and obesity|"Community based treatment of overweight and obese children using the Holbaek-method."
16119771|NCT02013830|Drug|bevacizumab [Avastin]|7.5mg/kg iv on day 1 of each 3 week cycle.
16119772|NCT02013830|Drug|capecitabine [Xeloda]|1600mg/m2/day po in 2 divided doses, on days 1 to 14 of each 3 week cycle.
16119773|NCT02013817|Drug|rituximab [MabThera/Rituxan]|Every 4 weeks for 6 cycles of induction, followed by maintenance therapy every 3 months x 8
16119774|NCT02013817|Drug|fludarabine|Every 4 weeks, 6 cycles
16119775|NCT02013817|Drug|cyclophosphamide|Every 4 weeks, 3 cycles
16119776|NCT02013804|Drug|MEDI0680 (AMP-514)|Study has planned dose escalation cohorts
16119777|NCT02013791|Drug|Vehicle|Vehicle of cyclosporine administered as per protocol
16119778|NCT02013791|Other|Sham|Sham administered to non-study eye as per protocol on Day 1
16119779|NCT02013791|Drug|Cyclosporine New Ophthalmic Formulation|Cyclosporine New Ophthalmic Formulation administered as per protocol
16119780|NCT02013778|Drug|HCQ|
16119781|NCT02013765|Drug|trastuzumab|Initial dose of 4 mg/kg i.v on Day 1, followed by weekly doses of 2 mg/kg i.v. beginning on Day 8 and continuing for up to 37 weeks.
16119782|NCT02013752|Device|Perineal protection device.|A device used to reduce perineal tears during delivery of the baby.
16119783|NCT02013726|Device|MBI Scan: The LumaGEM®|The LumaGEM Scanner is a dual-head, MBI scanner that has previously been cleared for medical marketing (510(k) number K111791), and has been used to image more than 5,000 patients to date. The LumaGEM MBI scanner is used as a diagnostic adjunct to mammography screening for problem cases The efficacy of MBI has been well documented in clinical trials. The LumaGEM MBI scanner is a dual-head, small field-of-view (FOV) device for developing an MBI image of Tc99m-Sestamibi uptake within the breast. The device consists of solid-state detectors, a data acquisition system, and a computer. The detectors are also used to immobilize the breast during image acquisition by mild compression. The detectors are housed in two heads that are positioned on both sides of a compressed breast.
16119784|NCT02013726|Device|3D Mammogram/Breast Tomosynthesis Scan: Selenia® Dimensions®|The breast tomosynthesis procedure involves x-ray imaging of the breast using a moving x-ray source and digital detectors composed of cesium iodide crystals on an amorphous silicon layer or of solely selenium in order to produce an image of the breast. This procedure is considered to basically be a modification of mammography and also is used as a diagnostic adjunct to mammography screening for problem cases.
16119788|NCT02013674|Biological|Allogeneic hMSCs|Allogeneic Adult Human Mesenchymal Stem Cells (MSCs) delivered via injection
16119789|NCT02013661|Procedure|Periodontal resective surgery|surgical periodontal debridement is performed after periodontal phase I
16119790|NCT02013648|Drug|Dasatinib|
16119791|NCT02013648|Drug|Cytarabine|
16119792|NCT02013648|Drug|Daunorubicin|
16119793|NCT02013648|Drug|Idarubicin|
16119794|NCT02013622|Drug|Brexpiprazole|Treatment (16 weeks) Up to 4 mg/day, once daily dose, tablets, orally
16119795|NCT02013609|Drug|Brexpiprazole|Treatment 12 weeks) - Up to 3 mg/day, once daily dose, tablets, orally
16119796|NCT02013596|Other|TEAS pretreatment|Electric stimulation was given through electrode attached to specific acupoints for 30mins before anesthesia induction
16119797|NCT02013596|Other|TEAS treatment|Transcutaneous Electrical Acupoint Stimulation was given to the patient at the same time of the start of anesthesia induction for 30mins
16119798|NCT02013583|Other|No intervention|This is an observational registry. No interventions are required or provided.
16119799|NCT02013570|Drug|Dexmedetomidine|2µg/kg dexmedetomidine in 2 ml normal saline (1 ml per tonsil),
16119800|NCT02013557|Behavioral|Text-message reminder|
16119801|NCT02013544|Drug|Placebo|
16119802|NCT02013544|Drug|Prasterone (DHEA)|
16119803|NCT02013531|Drug|Brexpiprazole|Treatment (6 weeks) - Up to 3mg/day, once daily dose, tablets, orally
16119804|NCT02013518|Behavioral|Cognitive Behavioural Therapy|11 standardised weekly one-hour sessions/6 modules: Module one - introduction to the programme. Module two - pleasant activities to improve mood and depressive symptoms. Module three - the use of external memory aids to help the patients to maintain independence in their daily life. Module four - establishing behavioural routines to reduce demands on memory. Module five - stimulates patients to actively engage in reminiscence and memories to improve mood and well-being. Module six - review of the programme and individual treatment goals.
16119805|NCT02013505|Other|Educational video|An educational video was developed based on the current paper instructions for bowel preparation. The video included a physician explaining the process, using more images and short clip videos of the example. The script of the video was approved by the patient education department of the University Hospital and language adjusted to 6th grade level.
16119806|NCT02013492|Drug|propranolol hydrochloride|Given PO
16119807|NCT02013492|Other|Correlative Studies|"Correlative studies will be conducted using the following materials:
~Plasma derived from peripheral blood.
~Peripheral blood mononuclear cells (PBMC) derived from patient blood
~Tumor tissue obtained at the time of core needle biopsy at the 2 month time point.
~Paraffin-embedded tumor tissue obtained pre-therapy to make the diagnosis of metastatic disease."
16119808|NCT02013479|Dietary Supplement|SelenoPRECISE|Produced by Pharma Nord ApS, Vejle, Denmark
16119809|NCT02013479|Dietary Supplement|Placebo|Produced by Pharma Nord ApS, Vejle, Denmark
16119810|NCT02013466|Dietary Supplement|Bolus ONS A|High-whey protein, leucine-rich, low-caloric ONS in powder format
16119811|NCT02013466|Dietary Supplement|Bolus ONS B|High casein-protein, low-caloric control product (isocaloric to product A)
16119812|NCT02013466|Dietary Supplement|Bolus ONS C|High casein-protein, high-caloric control product.
16119813|NCT02013466|Dietary Supplement|Bolus ONS D|high whey-protein, leucine-rich, high-caloric control product (isocaloric to product C)
16119814|NCT02013453|Drug|Omeprazole|40mg of Omeprazole will be administered daily by mouth.
16119815|NCT02013453|Drug|Carboplatin|Carboplatin will be administered over 30 minutes by continuous infusion.
16119816|NCT02013453|Drug|5FU|Administered by infusion.
16119817|NCT02013453|Drug|Paclitaxel|Administered by infusion.
16119818|NCT02013453|Drug|Pemetrexed|Administered by infusion.
16119819|NCT02013427|Drug|Naproxen|Take one 500mg naproxen capsule twice a day.
16119820|NCT02013427|Drug|Placebo|Take one placebo capsule twice a day.
16119821|NCT02013427|Drug|Omeprazole|Take one 20mg omeprazole capsule twice a day.
16119822|NCT02013414|Device|3D ultrasound-guided biopsy|Patients will have a PET/CT prior to the biopsy. The CT images will be combined with the PET images for improved localization of suspicious tumors. During the biopsy, the 3-D ultrasound images will be acquired immediately before the biopsy while the patient is on the table. The ultrasound images together with the PET images will be used to guide the targeted biopsy of the prostate.
16119823|NCT02013388|Drug|N91115|Given PO daily for 14 days
16119824|NCT02013388|Drug|Placebo|Given PO daily for 14 days
16119825|NCT02013388|Drug|N91115|Given PO only on Day 1
16119826|NCT02013388|Drug|Placebo-Day 1 only|Given PO- only on Day 1 (single dosed to match single dose treatments)
16119827|NCT02013375|Procedure|Haploidentical Transplant|All subjects will undergo pre-conditioning treatment with alemtuzumab (0.3 mg/kg Day -5, Day -4, Day -3) and total body irradiation (300cGy), followed by stem cell transplant, and post-transplant treatment with cyclophosphamide (50mg/kg/day) and sirolimus (target trough level of 10-15ng/mL).
16119828|NCT02013375|Drug|Alemtuzumab|On Day -7, the first test dose of alemtuzumab (0.03 mg/kg) will be administered and on Day -6, the second test dose of alemtuzumab (0.1 mg/kg) will be administered. Alemtuzumab (0.3 mg/kg) will be infused daily on Day -5, -4, and -3.
16119829|NCT02013375|Radiation|Total Body Irradiation|A 300cGy dose of TBI will be administered in a single fraction on Day -2.
16119830|NCT02013375|Drug|Cyclophosphamide|Cyclophosphamide (50 mg/kg IBW) IV, over approximately 1-2 hours, is given on Day 3 post-transplantation (ideally between 60 and 72 hours after marrow infusion) and on Day 4 (approximately 24 hours after Day 3 cyclophosphamide).
16119831|NCT02013375|Drug|Sirolimus|Sirolimus will be started on Day +5 (at least 24 hours after the completion of the cyclophosphamide infusion). The starting dose will be 12mg followed by 4mg PO daily. Doses will be adjusted to achieve a whole blood trough level of 4 - 12ng/mL.
16119832|NCT02013362|Drug|Pralatrexate injection|
16119833|NCT02013362|Dietary Supplement|Vitamin B12|
16119834|NCT02013362|Dietary Supplement|Folic Acid|
16119835|NCT02013349|Device|coronary intervention|
16119836|NCT02013336|Drug|MM-398 (Irinotecan Sucrosofate Liposome Injection) plus cyclophosphamide|
16119873|NCT02013011|Procedure|recruitment maneuver(RM) and positive end expiratory pressure(PEEP) or PEEP only|application of recruitment maneuver(RM) and positive end expiratory pressure(PEEP) in RM and PEEP group and application of only PEEP in PEEP group
16119837|NCT02013323|Drug|Scaling and root planing, and Septilin for 7 days|Subjects in septilin group received Septilin tablets (Septilin tablets, Himalaya Drug Company, India), 500 mg of 2 tablets to be taken thrice daily for 7 days after scaling and root planing and checked for clinical and micrbiological parameters at baseline, 10 days, 1 month, 3 months and 6 months.
16119838|NCT02013323|Drug|Scaling and root planing, and Placebo drug for 7 days|Subjects in placebo group received placebo tablets taken thrice daily for 7 days and checked for clinical and microbiological parameters at baseline, 10 days, 1 month, 3 months and 6 months
16119839|NCT02013310|Drug|HT-0712|
16119840|NCT02013310|Drug|Placebo|
16119841|NCT02013297|Radiation|SBRT treatment|"For Brain metastasis the SBRT treatment consists on 3 fractions of 8 Gy or 5 fractions of 7 Gy or 1 fraction of 18 Gy for a single metastasis which is less than 20 mm.
~For primary or secondary pulmonary tumors the SBRT treatment consists on 3 fractions of 15 Gy or 5 fractions of 10 Gy for peripheral lesions and on 5 fractions of 8 Gy for proximal lesions.
~For primary or secondary spinal or para-spinal tumors the SBRT treatment consists on 3 fractions of 9 Gy or 5 fractions of 7 Gy.
~For previously irradiated tumors (same locations) the SBRT treatment consists on 5 to 8 fractions of 5 Gy.
~For relapsed Ependymoma previously irradiated the SBRT treatment will be allocated by surgical stratified randomization and consists on either 3 fractions of 8 Gy or 5 fractions of 5 Gy."
16119842|NCT02013271|Device|Lutonix Paclitaxel Drug Coated Balloon (DCB)|Patients exposed to the DCB as part of their routine care.
16119843|NCT02013258|Drug|Intranasal oxytocin|This is a double-blind placebo controlled 2x2 study. Subjects will receive OT for 5 consecutive days during their 7 day stay. This will be followed by a wash out period of 4-6 weeks.
16119844|NCT02013258|Other|Placebo|This is a double-blind placebo controlled 2x2 study. Placebo will be given via intranasal spray, one spray in each nostril daily x 5 days. One month interval between arms of treatment.
16119845|NCT02013245|Biological|MTBVAC live vaccine|Live-attenuated Mycobacterium tuberculosis vaccine
16119846|NCT02013245|Biological|Commercially available BCG live vaccine|Live-attenuated Mycobacterium bovis vaccine
16119847|NCT02013232|Drug|Aripiprazole|
16119848|NCT02013219|Drug|Alectinib|Participants will receive 600 mg PO alectinib BID for 28 consecutive days during Cycle 1 and on Days 1-21 of each cycle thereafter (21-day cycles from Cycle 2 onwards) in Stage 1 and RP2D PO BID in Stage 2.
16119849|NCT02013219|Drug|Atezolizumab|Participants will receive 1200 mg atezolizumab IV infusion q3w on Day 8 of Cycle 1 and on Day 1 of each cycle thereafter in Stage 1 and in Stage 2.
16119850|NCT02013219|Drug|Erlotinib|Participants will receive 150 mg erlotinib PO QD for 28 consecutive days during Cycle 1 and on Days 1-21 of each cycle thereafter in Stage 1 (21-day cycles from Cycle 2 onwards) and RP2D PO QD in Stage 2.
16119851|NCT02013206|Drug|erlotinib [Tarceva]|Erlotinib tablets taken orally once daily in the morning.
16119852|NCT02013193|Device|Ranger DCB|After successful pre-dilatation the index lesion is treated with one or two Ranger DCB devices that completely cover the lesion. If two devices are deployed, overlap shall be minimal.
16119853|NCT02013193|Device|uncoated PTA balloon|The index lesion is treated with one or more uncoated standard PTA balloons that completely cover the lesion.
16119854|NCT02013167|Drug|Blinatumomab|Blinatumomab is administered as a continuous intravenous infusion (CIV).
16119855|NCT02013167|Drug|Standard of Care Chemotherapy|"FLAG (fludarabine, cytarabine arabinoside, and granulocyte colony-stimulating factor) ± anthracycline-based regimen (e.g. idarubicin 10 mg/m² days 1 & 3; fludarabine 30 mg/m² days 1-5; cytarabine arabinoside 2 g/m² days 1-5). Patients > 60 years: Idarubicin 5 mg/m² day 1 & 3; fludarabine 20 mg/m² day 1-5; cytarabine arabinoside 1 g/m² day 1-5
~HiDAC (high-dose cytarabine arabinoside) - based regimen ≥1 g/m²/day ± anthracycline and/or in combination with other drugs such as native Escherichia coli asparaginase, polyethylene glycol linked to asparaginase (PEG-asparaginase), vinca alkaloids, steroids, etoposide or alkylating agents
~High-dose methotrexate-based regimen (HDMTX; 500 mg/m² to 3 g/m² infused up to 24 hours) in combination with native E. coli asparaginase, PEG-asparaginase, vinca alkaloids, steroids, etoposide or alkylating agents.
~Clofarabine as a single agent as recommended in the prescribing information or clofarabine-based regimens with 20 mg/m²/day for up to 5 days."
16119856|NCT02013154|Drug|DKN-01|Administered by IV infusion
16119857|NCT02013154|Drug|Paclitaxel|Administered by IV infusion
16119858|NCT02013154|Drug|Pembrolizumab|Administered by IV infusion
16119859|NCT02013141|Drug|Telavancin|
16119860|NCT02013128|Drug|Ublituximab|Ublituximab (IV infusion)
16119861|NCT02013128|Drug|Ibrutinib|Ibrutinib oral daily dose
16119862|NCT02013115|Drug|Budesonide|Experimental: Cursurf and Budesonide The baby with respiratory distress syndrome was given Cursurf and Budesonide through intubation
16119863|NCT02013102|Drug|Decitabine Injection|Decitabine Injection 20mg/m2/d*5d, IV> 1h, one cycles per 4 weeks; Decitabine Injection 12mg/m2/d*8d, IV> 1h, one cycles per 4 weeks.
16119864|NCT02013089|Drug|Erlotinib or Gefitinib|Erlotinib 150mg talbet or Gefitinib 250 mg tablet per day for patients with EGFR gene alternation
16119865|NCT02013089|Drug|Everolimus|Everolimus 10 mg orally once daily every day for patients with mTOR gene alternation
16119866|NCT02013089|Drug|Imatinib|Imatinib 400 mg tablet orally per day for patietns with KIT, PDGFR, ABL gene alternation
16119867|NCT02013089|Drug|Sorafenib or Sunitinib|Sorafenib 400 mg twice a day at least one hour before or two hours after eating or Sunitinib 50 mg orally once a day with or without food for patients with VEGFR, KIT, RAF gene alternation
16119868|NCT02013089|Drug|Vandetanib|Vandetanib 300 mg orally once daily for patients with RET gene fusion.
16119869|NCT02013050|Drug|SGX942|
16119870|NCT02013050|Drug|Placebo|
16119871|NCT02013037|Drug|Eculizumab|"At the time of transplantation, 1200mg of Eculizumab will be administered via a 35 minute IV infusion, followed by thymoglobulin 1.5 mg/kg intravenous piggyback (IVPB). The administration of thymoglobulin will be repeated (if blood counts permit) for a total of five doses.
~On Day 1 post-transplant, 900 mg of Eculizumab will be given via an IV infusion.
~On Day 5 post-transplant, intravenous immunoglobulin (IVIG) 1 gram/kg will be administered daily for two consecutive days.
~On post-transplant days 7, 14, and 21 (+/- 2 days) 900mg of Eculizumab will be given via an IV infusion at each scheduled visit.
~On post-transplant days 28, 42, and 56 (+/- 2 days) 1200 mg of Eculizumab will be given via an IV infusion at each scheduled visit."
16119872|NCT02013024|Other|cryopreservation technique|
16119874|NCT02012998|Biological|HBVAXPRO 5µg|0.5mL intramuscular injection
16119875|NCT02012985|Biological|Oxabact OC5 capsules|The dose will be not less than (NLT) 1E+09 colony forming units (CFU) twice daily for 8 to 10 weeks. The dose (an enteric-coated size 4 capsule) will be administered orally with breakfast and dinner.
16119876|NCT02012985|Drug|Placebo capsules|An enteric-coated placebo capsule manufactured to mimic the OC5 capsule. The capsule will be administered orally with breakfast and dinner twice daily for 8 to 10 weeks.
16119877|NCT02012972|Behavioral|Referral for NCD care|Subjects in the NCD Risks group not already receiving care for the condition will be referred to a primary health clinic for care.
16119878|NCT02012959|Drug|Tolvaptan|
16119879|NCT02012946|Drug|Levosimendan|patient receiving levosimendan
16119880|NCT02012946|Drug|Dobutamine|patient receiving dobutamine
16119881|NCT02012933|Drug|3,4-diaminopyridine|10mg tablets for up to 100mg per day
16119882|NCT02012920|Drug|Seviteronel: given orally once daily in 28 day cycles|
16119883|NCT02012881|Behavioral|Physical activity intervention|Physical activity during recess, in academic subjects, active transportation and PA home work
16119884|NCT02012881|Behavioral|Usual practice|Normal curriculum
16119885|NCT02012868|Procedure|bariatric surgery|
16119886|NCT02012855|Behavioral|Exercise|
16119887|NCT02012855|Other|Diet (meal type)|
16119888|NCT02012842|Other|Non surgical periodontal treatment|Treatment of gingivitis: excavation and sealing of cavities, removal of overhanging restorations, extraction of hopeless teeth, supragingival calculus removal. Oral hygiene instruction, training and motivation will be given at each appointment. Treatment of periodontitis: subgingival scaling and root planing under local anesthesia.
16119889|NCT02012829|Behavioral|GPs communication skills and CRC screening|GPs of the intervention group received a four hours educational training focused on patients' centered care to improve GPs communication skills and enhance patients'participation in CRC mass screening . Triangulation of all qualitative data was performed in order to develop educational material and training based on the six components of the Patient-Centered Clinical Method . Two different scenarios were developed: one for a compliant patient, another for a non-compliant patient. Two videos were made with doctor and simulated patient. Interactive methods were used to elaborate educational training including role playing, the presentation of the video followed by an interactive discussion.
16119890|NCT02012816|Other|Peer-referral incentive program to increase VMMC uptake|The proposed intervention will allow men coming for male circumcision in randomly selected intervention clinics to refer up to 5 uncircumcised men in their social network and receive a monetary reward for each referred man who undergoes male circumcision. Men who come for circumcision will each be given 5 referral vouchers that they can then provide to uncircumcised men in their social network who may be interested in undergoing VMMC. If these uncircumcised men come to the CIDRZ VMMC clinics and undergo the circumcision procedure, they can present the referral voucher to clinic staff who will then retain the voucher until the man who made the referral comes to collect his incentive payment.
16119891|NCT02012803|Procedure|End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire suture|Operative treatment of achilles tendon rupture; End to end suturation by Krackow locking loop surgical technique with 2-Fiber-Wire suture and after operation identical protocol as conservative treatment.
16119892|NCT02012803|Other|Conservative treatment of achilles tendon rupture|Conservative treatment of achilles tendon rupture; 1 week equinus-cast without bearing, and then 6 week Vacoped orthosis with different equinus degrees and full weight bearing.
16119893|NCT02012790|Other|Diet|The dietary intervention provides dietary counseling, whole foods (enough for 2 meals and 2 snacks per day) including study oils
16119894|NCT02012777|Drug|propranolol|Propranolol hydrochloride is a synthetic beta-adrenergic receptor-blocking agent. This will be administered in an open-label single administration to 3 cohorts (10mg, 20mg, and 40mg) of children with sickle cell disease. Patient blood will be evaluated for red cell adhesion and patient data evaluated for safety monitoring.
16119895|NCT02012751|Device|Nevus doctor program|The Nevus doctor program supplies a diagnostic category of pigmented skin lesions based on dermatoscopy images.
16119896|NCT02012738|Behavioral|FORNET|"8 individual sessions:
~1 lifeline
~6 exposure sessions
~1 outlook"
16119897|NCT02012738|Behavioral|CBT|"7 individual sessions, according to the Integrated cognitive behavior change program manual, Bush et al., 1997, National Institute of Corrections, US Dept. of Justice."
16119898|NCT02012738|Other|Waiting List Control Group (camp)|Participants, if still meeting the criteria and interested, will receive FORNET by local counsellors after the 8-months follow up.
16119899|NCT02012738|Other|Waiting List Control Group (no camp)|Participants, if still meeting the criteria and interested, will receive FORNET by local counsellors after the 8-months follow up.
16119900|NCT02012725|Drug|Arm 1 MRI with gadolinium|Healthy volunteers will not receive gadolinium
16119901|NCT02012712|Behavioral|Personal Health Record (PHR)|"Iowa PHR is a Web-based application that features a tabbed interface design. Users can enter, view, and print their current and past medicines, allergies, health conditions, and health event tracking over time. An embedded tutorial video provides assistance with the system. The PHR was developed and refined using participatory design and focus group sessions as well as evaluation in a usability laboratory. The resulting design emphasizes the reduction of physical and cognitive demands on users, focusing on simplicity, readability, and quick navigation.
~Iowa PHR displayed a message when a user entered a medication with an associated Assessing Care of Vulnerable Elders project (ACOVE-3) safety concern. This included 16 safety issues for 12 drugs or drug classes with safety concerns. We also adapted four general medication use patient safety indicators from the ACOVE project and displayed them to all users on a rotating basis upon login."
16119902|NCT02012686|Device|TENS|transcutaneous electric nerve stimulation frequency of 100 Hz pulse duration of 200 µs wih stimulation intensity of feeling strong but non-painful paresthesia in the upper trapezius
16119903|NCT02012673|Device|Bronchoscopic lung volume reduction|Bronchoscopic lung volume reduction with the RePneu Lung Volume Reduction Coil system. The RePneu LVRC is an implantable device, delivered through a fiber-optic bronchoscope, designed specifically to treat patients suffering from emphysema. The Coil is intended to compress the most damaged parenchyma and tension the surrounding tissue, which increases elastic recoil, reduces hyperinflation and redirects air to healthier portions of the lung for more effective ventilation.
16120361|NCT02008773|Drug|placebo|placebo capsules 6/day oral for 16 weeks
16119904|NCT02012660|Other|Seasonality|The impact of high temperature during summer months on the prevalence of hyponatremia will be explores.
16119905|NCT02012647|Procedure|Transcranial Magnetic Stimulation (TMS)|Participants sit in a chair that looks like one in a dentist's office. A magnetic coil will be placed on the scalp on one side of the head, overlying the brain's motor cortex to stimulate the brain's output to the muscles in the opposite hand. A second magnetic coil will be placed on the scalp of the opposite side. Recordings from both hands will be made using the magnetic coils placed on scalp. Results will be compared for participants with and without Parkinson's Disease.
16119906|NCT02012647|Procedure|Motor Physiology Testing|Participants will be asked to move their upper and lower limbs while seated in a chair. Wireless EMG sensors placed on arm and leg muscles will record measurements during this procedure. Upper and lower limb testing will be performed separately.
16119907|NCT02012608|Drug|Glutamine|Oral glutamine for subjects undergoing breast conserving therapy
16119908|NCT02012608|Drug|Placebo|For subjects undergoing breast conserving therapy
16119909|NCT02012595|Other|[11C]donepezil PET|Positon Emission Tomography (PET) imaging of acetylcholinesterase using the ligand [11C]donepezil
16119910|NCT02012582|Drug|VAS203|i.v. infusion
16119911|NCT02012582|Drug|Saline|i.v. infusion
16119912|NCT02012569|Drug|TT-173|Bleeding of the lesion will be evaluated after each product application and will be recorded as bleeding vs. not bleeding. The product will be applied at 4 times for about 1 minute apart each application after skin graft obtention.
16119913|NCT02012569|Drug|Placebo|
16119914|NCT02012556|Drug|Tesamorelin|
16119915|NCT02012543|Dietary Supplement|Agar jelly|
16119916|NCT02012530|Procedure|HA|HA is widely applied in clinical practice with good results in many studies. HA forms part of the inflammatory process that can lead to the regeneration of cartilage in defective areas of the knee.
16119917|NCT02012530|Procedure|PRP|PRP uses reparative growth factors taken from the patient's own blood to create an environment in the knee conducive to wound healing that can fill cartilage defects. It's autologous origin, easy preparation and safety profile makes it a potentially ground breaking treatment option for knee cartilage defects and osteoarthritis.
16119918|NCT02012517|Drug|Prolonged antibiotic treatment|
16119919|NCT02012517|Drug|Short antibiotic course (standard of care)|
16119920|NCT02012491|Drug|Misoprostol|
16119921|NCT02012491|Drug|Mifepristone|
16119922|NCT02012478|Behavioral|MI- informed SMS program|
16119923|NCT02012465|Biological|Insulin protocol|"Within 24 hours of admission for diabetic participants, the inpatient oncology team will consult the endocrine team to apply the following part of the protocol, confirm NPH insulin dosing, and ensure that oral hypoglycemics are held.
~The following basal-bolus protocol is standard of care for inpatient diabetics requiring insulin at Barnes Jewish Hospital. The alternative practice has been to use 60-80% of the home insulin regimen while patients are hospitalized. For patients using home insulin, the admitting oncology team will enact one of these methods while awaiting the endocrine service's formal recommendations.
~Determine basal-bolus insulin requirement for the patient based on body weight: Patient weight (kg) x 0.5-0.7 Units/kg = Units of total insulin per 24 hours
~The TDD can be divided into 50% basal (glargine) and 50% meal time (lispro) insulin, plus sliding scale insulin (lispro)."
16119924|NCT02012452|Behavioral|Tobacco treatment|participants will be provided contingency management and cognitive behavioral therapy to help them quit tobacco prior to PTSD treatment
16119925|NCT02012452|Behavioral|Health Education|Participants will be provided education on a variety of health topics and will set health goals around each topic
16119926|NCT02012439|Behavioral|Mindfulness Based Cognitive Therapy|
16119927|NCT02012439|Behavioral|Cognitive Therapy|
16119928|NCT02012426|Behavioral|Weight management program|
16119929|NCT02012413|Device|PST - Pulsed Signal Therapy|PST application is a painless over-the-skin eletromagnetic field application. 9 sessions of application of electromagnetic therapy - PST - during 60 minutes
16119930|NCT02012413|Device|Placebo - Sham PST|"Placebo PST will be performed by applying the same device over the patient knee. The machine is not applying the PST but it appears to be on. In this way, patients are blinded to the intervation.
~9 sessions of application of Sham PST - during 60 minutes"
16119931|NCT02012400|Other|Exercise|The exercise group is given a 24-week individualized training program, including aerobic exercise, muscular training, relaxation exercises and stretching. Patients are asked to observe their asthma control daily and to mark in their diary asthma symptoms and activity limitations as well as duration, intensity and form of exercising on daily basis. They are also asked to perform PEF-measurements twice a day for one-week period every 4 weeks. The control group receives ordinary instructions.
16119932|NCT02012387|Biological|Active|Two injections will be administered every four weeks for four months, we will administer 4 doses within 16 weeks
16119933|NCT02012387|Biological|Placebo|Two injections will be administered every four weeks for four months, we will administer 4 doses within 16 weeks
16119934|NCT02012387|Biological|Open labeled|Two injections will be administered every four weeks for 8 months, we will administer 4 doses within 32 weeks
16119935|NCT02012374|Behavioral|Intensive Language Action Therapy|
16119936|NCT02012361|Procedure|Control Group|This group will be treated as any other patient would. Their anesthesia will be conducted as per routine with a target FiO2 of 0.25, (25%oxygen / 75%nitrogen) the only exception being that they will not be treated with inspired heliox.
16119937|NCT02012361|Procedure|Single-Dose Heliox Group|This group will be treated with a single dose of inspired 75/25 heliox (75% helium 25% oxygen) breathed continuously for 15 minutes over any convenient window prior to the inflation of the surgical tourniquet. This will be the only change in their clinical care. Their anesthesia will be conducted as per routine and as the anesthesia team sees fit with a target FiO2 of 0.25, the only exception being that they will receive 75/25 heliox prior to the inflation of the tourniquet.
16119938|NCT02012361|Procedure|Muscle Biopsy|During the course of the operation a small muscle biopsy will be collected.
16119939|NCT02012348|Other|Antibacterial soap with triclocarban|
16119940|NCT02012348|Other|Antibacterial soap + benzalkonium chloride|
16119941|NCT02012348|Other|Control soap|
16119942|NCT02012335|Drug|ECT + Ketamine|Brief pulse ECT with 0.05 mg/kg ketamine infusion in each session
16119943|NCT02012322|Dietary Supplement|Coenzyme Q10|100mg/day for three months
16119944|NCT02012322|Dietary Supplement|Coenzyme Q10|300mg/day for three months
16119945|NCT02012322|Dietary Supplement|Placebo|Three month period
16119946|NCT02012309|Biological|PCV-13|
16119947|NCT02012309|Biological|PPSV-23|
16119948|NCT02012296|Drug|enzalutamide|Given PO
16119949|NCT02012296|Drug|mifepristone|Given PO
16119950|NCT02012296|Other|laboratory biomarker analysis|Correlative studies
16119951|NCT02012296|Other|pharmacological study|Correlative studies
16119952|NCT02012283|Other|Food consumption|Cooked vegetables with spices or without spices
16119953|NCT02012270|Procedure|PRINCIPLES technique|"Principles technique for closure of midline laparotomy incisions
~closure with a running suture of a slowly absorbable monofilament suture- Monomax 2/0 of 150 cm length with a taper needle point ((1/2 circle, size: 30mm) (B.Braun, reference 0041453)
~the suture is started and ended with a self-locking knot, if more than one suture is used sutures are knotted separately, only the fascia will be sutured with small stitches close to each other
~the SL/WL ratio should be at least 4/1
~SL/WL = (150cm x number of sutures used) - (the suture remnants)
~the mean stitch length should be less than 4 cm (suture length / number of stitches placed)"
16119954|NCT02012270|Procedure|Conventional group|the fascia will be closed with the current method by the surgeons. There will be a great variation in sutures and techniques used. Study group: the fascia will be closed according
16119955|NCT02012257|Procedure|AMSA nerve block injectio|Sites of injection
16119956|NCT02012244|Drug|fentanyl-based analgesia|fentanyl based patient-controlled analgesia + additional pethidine for postoperative 48 hour
16119957|NCT02012244|Drug|local anesthetic wound infiltration-based anlagesia|continuous wound inflitration with ropivacaine + tramadol patient-controlled analgesia + additional ketorolac or propacetamol for postoperative 48 hour
16119958|NCT02012231|Drug|PLX8394|PLX8394 is a next-generation, orally available, small-molecule, selective inhibitor of BRAF.
16119959|NCT02012218|Drug|ADT|
16119960|NCT02012218|Drug|Brexpiprazole|
16119961|NCT02012205|Procedure|wet cupping|Participants assigned to the treatment group will receive wet-cupping therapy 3 times per week for 2 weeks
16119962|NCT02012192|Drug|Ganetespib|
16119963|NCT02012192|Drug|Paclitaxel|
16119964|NCT02012179|Other|Low sodium diet|Low sodium diet (65 mmol or 1500 mg/day)
16119965|NCT02012166|Drug|MK-0893 10 mg|MK-0893 10 mg administered orally in 240 mL of water
16119966|NCT02012166|Drug|MK-0893 40 mg|MK-0893 40 mg administered orally in 240 mL of water
16119967|NCT02012166|Drug|MK-0893 200 mg|MK-0893 200 mg administered orally in 240 mL of water
16119968|NCT02012166|Drug|MK-0893 1000 mg|MK-0893 1000 mg administered orally in 240 mL of water
16119969|NCT02012166|Drug|Placebo|Placebo administered orally in 240 mL of water
16119970|NCT02012166|Biological|Sandostatine®|Sandostatine® is a somatostatin analogue. At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period. These compounds are IV compatible and will be combined in one syringe. Intravenous Sandostatine® will be administered at 30 ng/kg/min.
16119971|NCT02012166|Biological|Insulin|At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period. These compounds are IV compatible and will be combined in one syringe. Intravenous insulin will be administered at 0.10 milli-international unit (mIU)/kg/min.
16119972|NCT02012166|Biological|Glucagon|At 24 and at 72 (Part I) or 120 (Part II) hours postdose, simultaneous infusions of the Sandostatine®, insulin, and glucagon will be administered over a 2-hour period. These compounds are IV compatible and will be combined in one syringe. Intravenous glucagon will be administered at 3 ng/kg/min.
16119973|NCT02012153|Biological|Mesenchymal Stromal Cells|
16119974|NCT02012140|Drug|ticagrelor|
16119975|NCT02012114|Other|Cysteamine bitartrate|No intervention
16119976|NCT02012101|Device|niv plus oxygen therapy|NIV given on Philips Respironics BiPAP Vision apparatus.
16119977|NCT02012101|Device|oxygen therapy|
16119978|NCT02012088|Drug|RCOMP|Day 1: Rituximab 375 mg/m2; Myocet® 50 mg/m2; cyclophosphamide 750 mg/m2; vincristine 1.4 mg/m2 (maximum 2 mg); prednisone 60 mg/m2 Days 2-5: Prednisone, 60 mg/m2 Administered every 21 days × 6 cycles
16119979|NCT02012088|Drug|RCHOP|Day 1: Rituximab 375 mg/m2; Doxorubicin 50 mg/m2; cyclophosphamide 750 mg/m2; vincristine 1.4 mg/m2 (maximum 2 mg); prednisone 60 mg/m2 Days 2-5: Prednisone, 60 mg/m2 Administered every 21 days × 6 cycles
16119980|NCT02012075|Drug|Extended-Release Carvedilol Sulfate|
16119981|NCT02012075|Drug|Sustained-release Metoprolol Succinate|
16119982|NCT02012062|Drug|TPF neoadjuvant chemotherapy|
16119983|NCT02012062|Drug|Concurrent chemotherapy with cisplatin during radiotherapy|
16119984|NCT02012062|Drug|Concurrent nimotuzumab during radiotherapy|
16119985|NCT02012062|Radiation|Radical radiotherapy|
16119986|NCT02012049|Drug|Risperdal OD Tab. 2mg|1 tablet Risperdal OD 2 mg administered orally.
16119987|NCT02012049|Drug|Risperdal Quicklet Tab. 2mg|1 tablet Risperdal Quicklet Tab. 2mg administered orally.
16119988|NCT02012036|Drug|Hexvix|"As this is a non-interventional study, detection of NMIBC with Hexvix is in a pre-defined group, chosen prior to and independently from the decision to enrol the subject in this study.
~The detection with Hexvix should be in accordance with local Summary of Product Characteristics [SmPC].
~Subjects will be treated in accordance with usual medical practice during their participation in this study, no additional assessment or tests will be required."
16119989|NCT02012023|Device|Low anterior resection|
16119990|NCT02012023|Device|tube ileostomy|
16119991|NCT02012023|Device|loop ileostomy|
16119992|NCT02012023|Device|accept reversal operation|
16119993|NCT02012023|Device|remove the tube ileostomy|
16119994|NCT02012010|Procedure|Manual syringe infusion method|Infuse the distension medium of hysteroscopy by manual syringe infusion method
16119995|NCT02012010|Procedure|Pump infusion method|Infuse the distension medium of hysteroscopy by pump infusion method
16119996|NCT02011997|Procedure|patients undergo cVATS segmentectomy|
16119997|NCT02011997|Procedure|Patients undergo cVATS lobectomy|
16120362|NCT02008760|Dietary Supplement|Omega Krill with D3|
16120706|NCT02006095|Behavioral|Neuropsychological testing|
16119998|NCT02011971|Drug|Vinpocetine|Vinpocetine is a chemical obtained from the leaves of the Lesser Periwinkle. It has been shown to improve cerebral metabolism and memory in animals and humans. In addition, it has been shown to enhance long-term potentiation, which has been linked to memory mechanisms. Furthermore, vinpocetine has been shown to have anticonvulsant effects and is more potent than several commonly used antiepileptic drug
16119999|NCT02011958|Drug|Liposomal Amphotericin B|"40 mg/kg total dose: IV infusion of 5mg/kg per day on day 1 to 5, 10,17,24 (when administered as a monotherapy)
~30 mg/kg total dose: IV infusion 5 mg/kg per day on day 1, 3, 5, 7, 9, 11 (when administered in combination with Miltefosine)"
16120000|NCT02011958|Drug|Miltefosine|"Orally taken every day during 28 days
~1 x 50 mg capsule per day if the patient weights less or equal to 25 kg
~2 x 50 mg capsules per day if the patient weights more than 25 kg (1 capsule in the morning / 1 capsule in the evening)"
16120001|NCT02011945|Drug|Dasatinib|
16120002|NCT02011945|Drug|Nivolumab|
16120003|NCT02011919|Device|Echopulse|HIFU Under ultrasound guidance
16120004|NCT02011906|Dietary Supplement|omega 3|
16120005|NCT02011906|Dietary Supplement|vitamin E|
16120006|NCT02011906|Dietary Supplement|placebo of omega 3|
16120007|NCT02011906|Dietary Supplement|placebo of vitamin E|
16120008|NCT02011893|Device|Tonic Stimulation|Prodigy Neurostimulation System with associated components
16120009|NCT02011893|Device|Burst Stimulation|Prodigy Neurostimulation System with associated components
16120010|NCT02011880|Dietary Supplement|Chinese Herbs|"Dietary Supplement:Experiment group:
~Fructus Cnidii,Psoralea Corylifolin L.，monkshood
~-Granules,Oral(add into the breast cancer postoperative prescription solution),A Pack(Fructus Cnidii 9g，Psoralea Corylifolin L. 15g，monkshood 9g),Bid Days,3 Periods(a month is a period),Until progression/unacceptable toxicity
~Breast Cancer Postoperative Prescription
~-Water Decoction,Oral,200ml,Bid Days,3 Periods(a month is a period),Until progression/unacceptable toxicity
~Dietary Supplement:Contrast Group:
~Breast Cancer Postoperative Prescription
~-Water Decoction,Oral,200ml,Bid Days,3 Periods( a month is a period),Until progression/unacceptable toxicity"
16120011|NCT02011867|Device|Cork Electrode|
16120012|NCT02011854|Device|rehabilitation|rehabilitation,To treat five times a week,Total course is eight weeks
16120013|NCT02011854|Device|Acupuncture|
16120014|NCT02011841|Drug|Rifaximin|rifaximin 1200 mg/day orally for 6 months
16120015|NCT02011841|Drug|Ciprofloxacin|ciprofloxacin 500 mg/day orally for 6 months
16120016|NCT02011828|Drug|Ergocalciferol|50,000 IU/week
16120017|NCT02011828|Drug|Placebo|Placebo tablet
16120018|NCT02011802|Device|Algosteril TM|
16120019|NCT02011802|Device|Sorbact TM|
16120020|NCT02011789|Dietary Supplement|Citrus Limonoid Beverage|The limonoid containing beverage will be 12-oz buffered, sterile, orange flavored, artificially sweetened, containing 60 mg vitamin C, 11 mg riboflavin and 250 mg limonin glucoside.
16120021|NCT02011789|Dietary Supplement|Placebo beverage|The placebo beverage will be 12-oz buffered, sterile, orange flavored, artificially sweetened, containing 60 mg vitamin C and 11 mg riboflavin.
16120022|NCT02011763|Biological|Avaxim 80U Pediatric: Inactivated Hepatitis A Virus|0.5 mL, Intramuscular (2 injection 6 months apart)
16120023|NCT02011750|Drug|Sodium Valproate treatment|Sodium Valproate treatment:During the entry period, all patients will have a placebo run-in for two weeks after which they will be evaluated for the outcome variables and then randomized to either Sodium Valproate (Depakote, DEP) or placebo (PLA) group in a 1:1 proportion. For the Sodium Valproate treatment group, this will be followed by a two week period to adjust the dose of DEP and attain therapeutic levels (50-100 µg/mL). Then DEP treatment will continue for 16 more weeks, after which DEP will be discontinued. Subject will be followed up for four weeks post-DEP discontinuation to monitor delayed adverse side effects.
16120024|NCT02011750|Drug|Placebo|Placebo: During the entry period, all patients will have a placebo run-in for two weeks after which they will be evaluated for the outcome variables and then randomized to either the experimental Sodium Valproate (Depakote, or DEP) or placebo (PLA) group in a 1:1 proportion. For the PLA group, this will be followed by a two week period of placebo during which members of the experimental Sodium Valproate (Depakote/DEP) will have DEP dose adjusted to attain therapeutic levels (50-100 µg/mL). Then PLA treatment will continue for 16 more weeks. Subjects will be followed up for four weeks post PLA-discontinuation to monitor for delayed adverse side effects.
16120025|NCT02011737|Drug|naftopidil 75mg|
16120026|NCT02011724|Device|Apligraf|
16120027|NCT02011698|Procedure|Lichtenstein technique groin hernia repair with mesh. Use of absorbale sutures for mesh fixation|
16120028|NCT02011698|Procedure|Lichtenstein technique groin hernia repair with mesh. Use of non absorbable sutures for mesh fixation|
16120029|NCT02011698|Procedure|Lichtenstein technique groin hernia repair with mesh. Use of fibrin biological glue for mesh fixation|
16120030|NCT02011685|Behavioral|Home BP Telemonitoring (HBPTM)|Participants will take home BP readings 3 days per week (morning and evening), one week out of every month for 12 months. BP readings will be transmitted wirelessly to a secure server. Patients' physicians will receive home BP reports via secure email before every scheduled appointment for the duration of the study to facilitate necessary treatment intensification and medication adjustments.
16120031|NCT02011685|Behavioral|Nurse Case Management (NCM)|Participants will complete 20 counseling phone calls with a nurse case manager (NCM) during the 12-month intervention: weekly calls for Months 1-2; biweekly calls for Months 3-4; and monthly calls for Months 5-12. The NCMs will provide self-management education, medication and appointment reminders, and will facilitate patient-provider communication. They will counsel patients on specific self-management behaviors using problem solving and motivational interviewing techniques. Target behaviors will include dietary changes, physical activity, weight loss, medication adherence, and smoking cessation. NCMs will also review patients' clinical information and provide feedback about abnormal lab results, and will communicate with the patient's physician as needed (e.g., regarding barriers).
16120032|NCT02011672|Other|nutrient-enriched milk|
16120033|NCT02011672|Other|regular milk|
16120034|NCT02011659|Drug|Ramosetron|
16120076|NCT02011256|Device|Implantable loop-recorder|All patients not diagnosed with atrial fibrillation with regular ECG or 72-hour Holter-monitoring will receive an ILR for 3 years.
16120495|NCT02007772|Device|nHF|nasal high-flow is used over a period of 6 weeks (outpatient)
16122110|NCT01994928|Procedure|Intubation|Intubation
16120035|NCT02011646|Behavioral|Healthy Weight|The PI will train 4 group leaders to deliver the intervention. Groups will be offered four times per week and consist of approximately 10 participants. Each group will be led by 2 group leaders and each group leader will lead two sessions per week during the 2.5 mo intervention period. Group leaders will digitally video-record all sessions of the first two groups they deliver so the PI can provide supervision and rate fidelity and competence for a random selection of 6 of these 12 sessions. Group leaders will transmit the video recordings via an encrypted, secure internet connection to Dr. Ochner (who was trained by Dr. Eric Stice, the creator of the intervention) within 3 d for supervision, and competence and fidelity assessments.
16120036|NCT02011646|Behavioral|Controlled Intervention|"The Weight of the World is a 51 min documentary focusing on the topics of obesity and healthy living. Via information presented by medical professionals and lifestyle experts, this film delves into issues related to preventing and combating obesity. Major topics include the importance of healthy eating and exercise behaviors and the changes that can be made by communities to reshape our lifestyles. Participants will be given a copy of the DVD. They will also be given the choice to stream it free on the web."
16120037|NCT02011633|Drug|HCP1201 500/10mg|500mg Metformin/10mg rosuvastatin fixed dose combination tablet orally in the morning on day1 or day8.
16120038|NCT02011633|Drug|Metformin SR 500mg|Co-administration of Metformin 500mg and Rosuvastatin 10mg orally in the morning on day1 or day8.
16120039|NCT02011633|Drug|Rosuvastatin 10mg|Co-administration of Metformin 500mg and Rosuvastatin 10mg orally in the morning on day1 or day8.
16120040|NCT02011620|Other|Isosorbide-5-mononitrate|Tablet Isosorbide mononitrate 20 mg; 1 tablet to be taken daily at night for a total duration of 6 months.
16120041|NCT02011594|Drug|Nimotuzumab|400mg Q2W intravenously
16120042|NCT02011594|Drug|Placebo|Normal saline
16120043|NCT02011568|Other|Therapeutic Hypothermia|
16120044|NCT02011542|Drug|VSL#3|This is a probiotic mixture
16120045|NCT02011542|Drug|Placebo|This is a pill with inactive ingredients.
16120046|NCT02011529|Other|TEAMcare treatment of diabetes|TEAMcare is an evidence-based collaborative care approach to the treatment of diabetes and psychiatric illness. It involves structured visits with a study nurse to monitor psychiatric symptoms, control of medical disease, and self-care activities. The nurses use motivational coaching to help patients solve problems and set goals for improved self-care and medication adherence. Medications for diabetes, hypertension, and hyperlipidemia are monitored and therapy intensified based on treat-to-target guidelines. All of these process and outcome measures are tracked in a registry designed for the study, and the nurses receive weekly supervision with a psychiatrist, an endocrinologist and a psychologist in order to review new cases and to track progress. Once a patient achieves targeted levels for relevant measures, the patient and the nurse develop a maintenance plan.
16120047|NCT02011516|Drug|Baclofen|
16120048|NCT02011516|Behavioral|Psychosocial|
16120049|NCT02011516|Drug|Placebo|
16120050|NCT02011503|Procedure|Multi-layer compression therapy|Application of multi-layer compression therapy.
16120051|NCT02011503|Other|Application of dHACM|Application of dHACM to ulcer.
16120052|NCT02011490|Drug|sugammadex|sugammadex 4 mg/kg IV bolus
16120053|NCT02011477|Other|Neural Glide|This technique involves two movements, throughout several joints to glide the nerves. The subject sit on a couch with the right lower limb extended and the left lower limb flexed. The therapist will take the subject's head by putting his hands on the suboccipital and front region. In the initial movement, performe craniocervical flexion in the subject, while he helped with his right elbow to rectify the dorsal spine of the subject; at the same time, the subject performed dorsiflexion of the right ankle. In the final movement, the subject must increase thoracic kyphosis at the same time as performing plantarflexion in the right ankle; also, the therapist performed craniocervical extension in the subject
16120054|NCT02011477|Other|Neural stretching|In the start position, the subject was supine on a couch, with knees bent with the right leg above the left, and supported with the popliteal zone. Both hands were crossed over the chest. The therapist was on the subject´s side, with his knee below the subject's head, bringing stability. One hand was placed on the occipital, and the other hand was placed over the crossed hands of the subject
16120055|NCT02011464|Drug|Exparel|Exparel is infiltrated into posterior compartment for pain control
16120056|NCT02011464|Other|Saline|Saline is infiltrated into posterior compartment for control
16120057|NCT02011451|Drug|95% Pure ECGC capsules 200mg|Theaphenon 95% 95% Pure EGCG
16120058|NCT02011451|Drug|Placebo Comparator:|
16120059|NCT02011438|Behavioral|UTalk|Prevention intervention delivered in group format adapted from IPT-AST, for adolescents who experience peer victimization and who are at risk for developing social anxiety and depression.
16120060|NCT02011425|Device|mandibular advancement appliance|mandibular advancement appliance
16120061|NCT02011399|Procedure|Brain Computer Interface for Mu Rhythm|"Device: Brain Computer Interface Subjects will wear an EEG (electrode) cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate a computer. Subjects will be asked to participate in 4-20 sessions.
~Arms: Brain Computer Interface Keyboard"
16120062|NCT02011386|Drug|Treatment|
16120063|NCT02011373|Procedure|fixation technique using a sterile synthetic liquid tissue glue: IFABOND™|
16120064|NCT02011360|Other|Low Carbohydrate diet|Low carbohydrate diet: 15%carb; 65%fat; 20% protein
16120065|NCT02011360|Other|Low Fat diet|Low Fat diet: 65%carb; 15%fat; 20% protein
16120066|NCT02011347|Drug|Ketamine|
16120067|NCT02011347|Drug|Placebo|
16120068|NCT02011334|Drug|tocilizumab [RoActemra/Actemra]|162 mg will be administered once weekly by subcutaneous injection.
16120069|NCT02011321|Drug|clevidipine|clevidipine infusion x4 hours
16120070|NCT02011308|Device|Green light Laser|Laser vs TURP
16120071|NCT02011308|Device|Transurethral Resection of the Prostate (TURP)|Laser vs TURP
16120072|NCT02011295|Procedure|ankle arthroscopy with debridement and microfracture of the OLT|ankle arthroscopy with debridement and microfracture of the OLT
16120073|NCT02011295|Other|Bone Marrow Aspirate injection|
16120074|NCT02011282|Other|Patients will receive daily sessions of electro-neuro-stimulation in the quadriceps muscle for 10 days|
16120075|NCT02011269|Biological|Trichuris Suis Ova|
16120234|NCT02009722|Drug|Hydromorphone|Hydromorphone (Dilaudid) is administered in the intrathecal space for post-operative pain control
16120077|NCT02011230|Other|Hoist Group|Hoist is a commercially available drink that is sold locally. This solution is isotonic meaning that it contains similar concentrations of salt and sugar that are found in the human body
16120078|NCT02011217|Other|Rye crisp bread A|In a randomized cross-over design each subject receive one of three iso-caloric breakfasts on three different occasions, separated by 1 week wash-out period.
16120079|NCT02011217|Other|Rye crisp bread B|In a randomized cross-over design each subject receive one of three iso-caloric breakfasts on three different occasions, separated by 1 week wash-out period.
16120080|NCT02011217|Other|Wheat crisp bread C|In a randomized cross-over design each subject receive one of three iso-caloric breakfasts on three different occasions, separated by 1 week wash-out period.
16120081|NCT02011204|Device|Electrical impedance myography (EIM)|"In EIM, high-frequency alternating electrical current is applied to localized areas of muscle via surface electrodes and the consequent surface voltage patterns analyzed.
~EIM is very sensitive to the compositional and structural elements of muscle. Data from both human subjects and animal disease models, including ALS, spinal muscular atrophy (SMA), and Duchenne muscular dystrophy (DMD), show that EIM may be sensitive to a variety of pathological states. It is anticipated that EIM will thus likely be able to assist in quantifying the severity of the disease affecting various muscle groups as well as in measuring changes in the disease over time."
16120082|NCT02011191|Dietary Supplement|Biotin Supplementation|10,000 micrograms biotin supplement daily for 8 weeks
16120083|NCT02011191|Dietary Supplement|Sugar Pill|Identical sugar pill, identical bottle as the biotin supplementation group
16120084|NCT02011178|Procedure|Optimal medical treatment and surgery|
16120085|NCT02011178|Procedure|Optimal medical treatment|
16120086|NCT02011165|Procedure|Positioning measuring device|A tennis ball in the night shirt will prevent supine position during sleep.
16120087|NCT02011139|Behavioral|Cognitive-behavioral group therapy|
16120088|NCT02011126|Drug|Imetelstat Sodium|Given IV
16120089|NCT02011126|Other|Laboratory Biomarker Analysis|Optional correlative studies
16120090|NCT02011113|Drug|Pomalidomide|4 mg oral pomalidomide once daily Days 1-21 of each 28-day cycle
16120091|NCT02011113|Drug|Dexamethasone|40 mg or 20 mg oral dexamethasone once daily on Days 1, 8, 15, 22 of each 28-day cycle
16120092|NCT02011100|Dietary Supplement|Carnosine|
16120093|NCT02011087|Procedure|bioelectric impedance analysis|Undergo bioelectric impedance analysis
16120094|NCT02011048|Procedure|Endoscopic components separation|Endoscopic components separation hernia repair
16120095|NCT02011022|Drug|3g MTX|The group of patients which are treated with 3g/m2 MTX, low risk ALL or NHL
16120096|NCT02011022|Drug|5g MTX|The group of patients which are treated with 5g/m2 MTX, they are high or middle risk ALL patients
16120097|NCT02011009|Other|HIV seropositive patients|During a routine visit, a self-administered anal swab will be proposed as well as an anonymous questionnaire about sexual practices. In addition to usual outpatient treatment an examination and an evaluation of a possible sexually transmitted infection (STI) will be realized. Some questions about risk factors traditionally associated with carriage of resistant bacteria will also be investigated with the aid of the questionnaire such as: use of antibiotics during the year, travel in areas at risk.
16120098|NCT02010996|Procedure|vacuum assisted closure|Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site.
16120099|NCT02010996|Procedure|Axillary dissection|Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids).
16120100|NCT02010983|Other|chromoendoscopy|chromoendoscopy (lugol stain and virtual chromoendoscopy)
16120101|NCT02010970|Drug|Group 1 AZD3293|AZD3293 oral solution
16120102|NCT02010970|Drug|Group 2 AZD3293|AZD3293 oral solution
16120103|NCT02010970|Drug|Group 3 AZD3293|AZD3293 oral solution
16120104|NCT02010970|Drug|Group 1 Itraconazole|itraconazole capsule
16120105|NCT02010970|Drug|Group 2 Diltiazem|Diltiazem ER tablet
16120106|NCT02010970|Drug|Group 3 Midazolam|midazolam syrup
16120107|NCT02010957|Other|FDG positron emission tomography|2 consecutive imaging studies (diagnostic study) within 1-2 weeks: FDG-PET and 123I-Iodometomidate imaging in patients with an indeterminate adrenal neoplasm
16120108|NCT02010957|Other|Iodometomidate imaging|2 consecutive imaging studies (diagnostic study) within 1-2 weeks: FDG-PET and 123I-Iodometomidate imaging in patients with an indeterminate adrenal neoplasm
16120109|NCT02010944|Drug|solifenacin succinate|oral
16120110|NCT02010944|Drug|mirabegron|oral
16120111|NCT02010944|Drug|mirabegron/solifenacin succinate|oral
16120112|NCT02010918|Drug|glucosamine sulfate /chondroitin sulfate - capsules|500 mg glucosamine sulfate + 400 mg chondroitin sulfate - capsules; One capsule, three times daily.
16120113|NCT02010918|Drug|glucosamine sulfate /chondroitin sulfate - sachet|1500 mg glucosamine sulfate / 1200 mg chondroitin sulfate - sachet; One sachet preparation, once daily.
16120114|NCT02010918|Drug|Cosamin DS®|500 mg glucosamine hydrochloride + 400 mg chondroitin sulfate - Capsules; One capsule, three times daily.
16120115|NCT02010905|Drug|Losartan|
16120116|NCT02010905|Drug|Placebo|
16120117|NCT02010892|Procedure|Stent Grafting (ESR)|
16120118|NCT02010892|Procedure|Open Surgery (OSR)|
16120119|NCT02010866|Behavioral|counseling|in-person counseling through RFWP offered to distressed respondents on the ISP and others who seek counseling (due to other reasons for referral)
16120120|NCT02010853|Other|IRMf|"evaluation in resting state fMRI during three successive visits:
~During the acute phase within 24 hours
~In 72 hours
~In 3 months"
16120121|NCT02010840|Behavioral|Psychoeducation program|
16120122|NCT02010827|Biological|isoglycemic intravenous glucose infusion and Glucagon infusion, day C|Infusion of 0.8ng/kg/min glucagon from time 0-25min
16120123|NCT02010827|Biological|Oral glucose tolerance test, day A|
16120124|NCT02010827|Biological|intravenous iv glucose infusion, day B|
16120125|NCT02010801|Procedure|irreversible electroporation|
16120126|NCT02010801|Device|nanoknife AngioDynamics US Ltd|
16120127|NCT02010788|Biological|botulinum toxin Type A|Botulinum toxin Type A treatment for Neurogenic Detrusor Overactivity or Overactive Bladder as per local standard of care in clinical practice.
16120128|NCT02010775|Biological|botulinum toxin Type A|Botulinum toxin Type A (BOTOX®) administered intramuscularly to the bilateral masseter muscles on Day 1 and retreatment at Day 180 if applicable.
16120129|NCT02010775|Drug|Normal saline|Normal saline (placebo) administered intramuscularly to the bilateral masseter muscles.
16120130|NCT02010762|Drug|Vitamin D|25.000 IU oral drops
16120131|NCT02010762|Drug|Placebo|placebo oral drops
16120132|NCT02010736|Other|Single treadmill gait training with additional loading|
16120133|NCT02010723|Procedure|surgery|crossectomy and avulsion of the varicose anterior accessory great saphenous vein (AAGSV) under local anesthesia
16120134|NCT02010723|Drug|sclerotherapy with aethoxysclerol foam|foam sclerotherapy with aethoxysclerol foam
16120135|NCT02010710|Device|INFANT software|The decision-support software to be evaluated in INFANT has been designed to run on the K2 data collection system (Guardian®). The data collection system (Guardian®) is a system for managing information from labour monitoring. It displays the CTG on a computer screen alongside other clinical data which are collected as part of routine clinical care. As such, it replaces conventional paper labour notes, the CTG machine and other recording systems for documenting care during labour.
16120136|NCT02010697|Behavioral|Messages targeting nonsmokers|
16120137|NCT02010697|Behavioral|Messages targeting smokers|
16120138|NCT02010684|Behavioral|Empowerment and CBT Classes|"Participants randomized to the intervention arm will receive a manual with 3 CBT modules and 1 Diabetes Empowerment module. CBT Module 1 covers Understanding Depression and Diabetes, Module 2 How Thoughts Affect Your Mood and Diabetes Care, Module 3 How Activities Affect Your Mood and Diabetes Care. The Diabetes Empowerment Module covers topics including the following: food, exercise, medicine, diabetes and your health, social support, communication skills, and community resources."
16120139|NCT02010671|Other|Survey|Survey
16120140|NCT02010658|Other|Cognitive Aid|
16120141|NCT02010645|Drug|Eltrombopag|Starting dose of Eltrombopag is 100 mg by mouth daily for each 28 day cycle. East Asians will start at 50 mg by mouth daily for each 28 day cycle.
16120142|NCT02010645|Drug|Decitabine|Starting dose of Decitabine is 20 mg/m2 by vein on Days 1-5 for each 28 day cycle.
16120143|NCT02010632|Drug|Generic clopidogrel product Apolets®|"Clopidogrel 75 mg once daily for 7 days
~Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
16120144|NCT02010632|Drug|Original clopidogrel product Plavix®|"Clopidogrel 75 mg once daily for 7 days
~Blood collection at 0 (before dosing), 1, 2, 4, 6, 8, 12, 24 hours after the last dose, administered at day 7"
16120145|NCT02010619|Behavioral|Cognitive behavior therapy|
16120146|NCT02010619|Behavioral|Supportive therapy|
16120147|NCT02010606|Biological|Dendritic cell vaccination, in addition to standard temozolomide chemotherapy and involved field radiation therapy|Patients will receive a series of four vaccines given weekly during the Induction phase, followed by vaccinations every 8 weeks during the Maintenance phase for as long as patients remain on the study or until the vaccine supply is depleted. In addition to the investigative treatment, patients with newly diagnosed glioblastoma will receive standard temozolomide chemotherapy and radiation treatment, with the vaccine Induction phase beginning at the conclusion of radiation.
16120148|NCT02010606|Biological|Dendritic cell vaccination, with optional bevacizumab treatment for patients previously treated with bevacizumab|Patients will receive a series of four vaccines given weekly during the Induction phase, followed by vaccinations every 8 weeks during the Maintenance phase for as long as patients remain on the study or until the vaccine supply is depleted. Patients with recurrent glioblastoma will not receive additional treatment other than the investigative treatment as long as they remain on study, unless they were previously treated with bevacizumab, in which case they will be allowed to continue receiving bevacizumab
16120149|NCT02010593|Drug|Dapivirine Vaginal Ring|Dapivirine, a non-nucleoside reverse-transcriptase inhibitor (NNRTI), is a substituted amino- pyrimidine (DAPY) derivative with potent antiviral activity against HIV-1. Dapivirine is chemically described as 4-[[4-[(2,4,6-trimethylphenyl)amino]-2- pyrimidinyl]amino]benzonitrile.6 The dapivirine matrix VR is a flexible ring containing 25 mg of drug substance dispersed in a platinum-catalyzed-cured silicone matrix. Dapivirine is known to be well-suited for delivery via VR,
16120150|NCT02010593|Drug|Placebo Vaginal Ring|The placebo VR is a flexible, platinum-catalyzed-cured silicone matrix ring, identical to dapivirine Ring-004, containing no active drug.
16120151|NCT02010567|Drug|CRLX101|CRLX101 is an experimental nanoparticle formulation of the anticancer agent camptothecin manufactured by Cerulean Pharma Inc..
16120152|NCT02010567|Drug|Capecitabine|Capecitabine is an oral fluoropyrimidine pro-drug, metabolically converted to 5-fluorouracil after administration. It is indicated as adjuvant treatment in patients with stage III colorectal cancer (Dukes' C colon cancer), and as first-line treatment of metastatic colorectal cancer.
16120153|NCT02010567|Radiation|Radiotherapy|"This protocol allows physician discretion as to the use of Intensity Modulated Radiation Therapy (IMRT) or 3D conformal planning techniques.
~Radiation begins on Day1 of neoadjuvant chemotherapy and continues for 28 (if <T4) or 30 (T4 disease) consecutive weekdays. Patient will receive 1.8 Gy daily fractions of radiotherapy without a break except for weekends and holidays.
~Dose is to be prescribed to an isodose surface that encompasses the planning target volume (PTV) and that satisfies the dose uniformity guidelines below. The minimum dose to PTV 1 and PTV 2 shall be no less than 95% of the protocol specified dose for that volume."
16120154|NCT02010567|Procedure|Surgery|Surgery will take place at least 6 weeks post completion of chemoradiotherapy in patients with resectable disease; tissue from surgical resection will be preserved for correlative studies in those patients who do not achieve a pCR.
16120155|NCT02010554|Behavioral|Brief Education|Give patients a pamphlet discussing pros and cons of disease modifying therapies
16120156|NCT02010554|Behavioral|Motivational Interviewing-Cognitive Behavioral Therapy|A telephone based talk therapy discussing pros and cons of medication use in MS.
16120157|NCT02010502|Dietary Supplement|Beetroot juice|
16120158|NCT02010502|Dietary Supplement|Beetroot powder|
16120159|NCT02010502|Dietary Supplement|Placebo|
16120320|NCT02009059|Device|Non-invasive temperature in hypothermia|accuracy of non-invasive temperature measurement in deep hypothermia compared to core temperature
16120160|NCT02010489|Other|12 week Exercise Program|Patients will be provided with a tour of the Reh-Fit Centre, exercise prescription, and supervised exercise session. The exercise prescription consists of 3 weekly 60-minute sessions, each with 10 minutes warm-up, 30 minutes endurance, 20 minutes strength training and 5 minutes cool-down. The program is overseen by an accredited Exercise Physiologist. Initial exercise intensity is determined by the kinesiologist and based on the patient's baseline fitness level. Goal intensity of endurance activity is based on the heart rate reserve (HRR) method. This is captured with a heart rate monitor at initial assessment and recorded on exercise logs. There are check-ins at each exercise session to determine progress (time, reps, weight, sets, etc). Endurance activities include treadmill, elliptical, walking, and aerobics. Strength training includes upper body, lower body, and trunk circuits. Patients will be asked to attend three weekly sessions at the Reh-Fit Centre.
16120161|NCT02010463|Other|Exercise|
16120162|NCT02010450|Other|Wearable Blanket (Sleep Sack)|
16120163|NCT02010450|Other|Incentive Item|
16120164|NCT02010437|Drug|Sodium Tetradecyl Sulphate (STS)|
16120165|NCT02010424|Other|control group|standard IVF protocol
16120166|NCT02010424|Device|Primo Vision embryo culture dish (CE labeled, Vitrolife)|
16120167|NCT02010411|Drug|Prolastin (drug)|Outcomes compared to saline or no intervention in each subject.
16120168|NCT02010398|Other|Cross-Training healthy subjects|The phase of intervention will consist of a 6-week cross-training of the stronger limb employing an isokinetic contraction regimen at maximal intensity.
16120169|NCT02010398|Other|Cross-Training multiple sclerosis|The phase of intervention will consist of a 6-week cross-training of the less-impaired limb employing an isokinetic contraction regimen at maximal intensity.
16120170|NCT02010398|Other|Standard-training multiple sclerosis|The phase of intervention will consist of a 6-week standard strength training of the more-impaired limb employing an isokinetic contraction regimen performed at maximal intensity.
16120171|NCT02010385|Drug|Octreotide|
16120172|NCT02010385|Drug|Saline|
16120173|NCT02010372|Other|Reminder Recall Report|Practices (administrators) that are randomized to this intervention will receive training in how to run reminder recall reports for patients due to receive any dose of HPV vaccine. After the training has been completed, administrators will be asked to continue running regularly scheduled reports over the course of one year. A tracking log will be sent regularly to the research team.
16120174|NCT02010372|Other|Audit-Feedback/Immunization Forecasting Reports|Practices (administrators) that are randomized to this intervention will receive training in how to run audit-feedback/immunization forecasting reports for patients due to receive any dose of HPV vaccine and to determine the % of patients in their practice who have received at least one dose of HPV vaccine within the study period. After the training has been completed, administrators will be asked to continue running regularly scheduled reports over the course of one year. A tracking log will be sent regularly to the research team.
16120175|NCT02010359|Drug|Lovaza|Lovaza 4 grams per day
16120176|NCT02010359|Drug|Placebo|Placebo pill
16120177|NCT02010346|Procedure|Early headgear treatment|The treatment with headgear is done as early treatment, beginning at ages 7-8 (Arm 1), or later, durning the maximal growth (arm 2)
16120178|NCT02010333|Drug|Ha44 Gel 0.74% w/w|HA44 Gel 0.74% comprises of Abametapir as the active pharmaceutical ingredient and Benzyl Alcohol as one of the excipients.
16120179|NCT02010320|Other|Computer dosing|Pharmacokinetic population model for individual dose estimations of tacrolimus based on concentrations measurements and inclusion of relevant covariates
16120180|NCT02010320|Other|Standard dose determination|Tacrolimus dose determination according to trough concentrations and standard TDM at the clinic
16120181|NCT02010307|Other|blood extraction|6 ml blood extraction from each patients in all 3 arms of the study
16120182|NCT02010294|Genetic|DNA samples, GAS strains|DNA samples,GAS strains
16120183|NCT02010281|Device|rTMS of prefrontal or motor cortex|description:rTMS of the motor or prefrontal cortex (repetitive magnetic stimulation targeting the motor or prefrontal cortex) assisted with neuronavigation
16120184|NCT02010268|Other|Collection of stool samples|A stool sample will be collected once a week from birth until discharge from the hospital, and every day during digestive episodes, that is to say during an interruption of enteral nutrition for more than 48 hours.
16120185|NCT02010255|Drug|LDV/SOF|LDV/SOF FDC tablet administered orally once daily
16120186|NCT02010255|Drug|RBV|RBV tablets administered orally in a divided daily dose
16120187|NCT02010242|Drug|GKT137831|1 capsule of 100 mg twice a day for the first 6 weeks of treatment, and 2 capsules of 100 mg twice a day for next 6 weeks of treatment
16120188|NCT02010242|Drug|Placebo|1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment.
16120189|NCT02010216|Drug|tocilizumab [RoActemra/Actemra]|8 mg/kg by intravenous infusion every 4 weeks
16120190|NCT02010203|Biological|HS-410|Vaccine derived from irradiated cancer cells genetically engineered to continually secrete gp96
16120191|NCT02010203|Biological|Placebo|Injection containing sterile solution but no cells
16120192|NCT02010203|Biological|BCG|Vaccine derived from a live bacterium
16120193|NCT02010164|Dietary Supplement|Co-enzyme Q10|600mg for 3 months
16120194|NCT02010151|Other|NAD-CPR|When Dispatcher detects OHCA, short message service (SMS)about the OHCA event and information about the location of nearest AED is sent to trained laypersons within geographically accessible area.
16120195|NCT02010138|Procedure|small-extent peeling|The internal limiting membrane was peeled in round shape with the radius of 0.75-disc diameter radius (1.5-disc diameter in total) centering at the center of the macular hole.
16120196|NCT02010138|Procedure|large-extent peeling|The internal limiting membrane was peeled in round shape with the radius of 1.5-disc diameter radius (3.0-disc diameter in total) centering at the center of the macular hole.
16120197|NCT02010112|Other|Breath Test Collection bags|Breath Collection bags will be used to collect breath of subjects before and after ingestion of 13-C breath test substrate
16120198|NCT02010099|Drug|PP110 Gel|
16120199|NCT02010099|Drug|PP110 Medicated wipes|
16120200|NCT02010099|Drug|Preparation-H Cream|
16120201|NCT02010086|Behavioral|Individual Cognitive Behavioral Therapy|Therapists will work with families for 32 weekly sessions, each lasting 90 minutes, implementing the CBT manual for children with ASD (Wood et al., 2007).
16120202|NCT02010086|Behavioral|Standard Community Treatment|In this condition, the child meets with a therapist for 32 weekly sessions, each 90 minutes. Therapists use an established manual to provide a standard community therapy treatment.
16120203|NCT02010060|Behavioral|Aerobic Exercise Training|Individuals randomized to the aerobic exercise training group will participate in 6 months of supervised exercise training. Exercise dose (expressed in kilocalories per kg per week [KKW]) during aerobic training will be 8KKW in week 1, 10KKW in week 2 and 12 KKW in week 3. the exercise dose of 12KKW will be maintained throughout the intervention. Pedometers will be worn by participant in blind-mode throughout the intervention, and removed during exercise training sessions. Participants will enter information about whether they wore their pedometer on the study website. Aerobic exercise group participants will be told to make no conscious alterations to their physical activity or dietary habits
16120204|NCT02010060|Behavioral|Aerobic Exercise+ Physical Activity|The Aerobic Exercise+ Physical Activity Group will participate in the same supervised exercise training intervention as the Aerobic Exercise Group, but will also increase the amount of non-exercise physical activity in their daily lives. After week 6 of intervention, participants will incrementally increase Non-Ex PA until they reach an average of 3,000 steps/day above baseline. Non-Ex PA will be increased with moderate physical activity consistent with daily living (i.e. leisurely walking in the evening, walking the dog etc.). Participants will also periodically have life-style counseling sessions with instructors with expertise in behavioral change support to their dietary habits
16120205|NCT02010047|Device|ALK qPCR assay|72 IHC ALK-negative and 72 IHC ALK-positive FFPE samples will tested with FISH and qPCR to determine the sensitivity and specificity of the ALK qPCR assay.
16120206|NCT02010034|Drug|Omegaven|Omegaven will be used in place of soy oil Intralipid
16120207|NCT02010021|Drug|Letrozole|Patients will receive Letrozole for 10-21 days prior to surgical resection of tumor tissue. This tissue will be used ex-vivo to study cell growth signaling pathway. The results will be compared to arm of the study with no intervention.
16120208|NCT02010008|Behavioral|Motivational Interviewing Intervention|An individual-level intervention that implements a motivational interviewing intervention led by a promotora
16120209|NCT02009995|Behavioral|Aerobic Training (AT)|All subjects will participate in a 10-week ramp-in period with the goal of achieving 150 minutes of moderate-to-vigorous physical activity per week. Walking and jogging will be the primary modes of achieving the prescribed aerobic activity as these are the modes of aerobic exercise that are most accurately recorded by an accelerometer. Subjects will use the Rate of Perceived Exertion (RPE) to guide aerobic exercise intensity. Aerobic activity will be objectively monitored by the Technogym MyWellness Key (MWK) accelerometer, which is a lightweight device worn on the waistband.
16120210|NCT02009995|Behavioral|AT plus Primarily Home-Based Resistance Band Training|"The bands + AT group will engage in RBT 3 times per week, progressing to 3 sets of 10-15 repetitions of 12 exercises. The exercises will be: chair squat, sitting chest press, seated rear fly, seated row, overhead press, lateral raise, biceps curl, triceps extension, leg extension, hamstring curl, gluteal extension, and abdominals. The resistance band exercise sessions will be between 25-60 minutes.
~Participants in this group will attend supervised group sessions weekly in weeks 1-4, every 2 weeks in weeks 5-8, and every 4 weeks thereafter to ensure proper form and appropriate progression. Participants in this group will be responsible to complete all remaining sessions (a total of 3 per week, including supervised sessions) at home on their own time."
16120211|NCT02009982|Procedure|Cardioneuroablation|Catheter Ablation of Vagal Inputs in Left Atrium
16120212|NCT02009982|Device|Biosense Webster Navistar ThermoCool Diagnostic/Ablation Deflectable Tip Catheter|This is the device that will be used to perform the Cardioneuroablation procedure
16120213|NCT02009956|Device|Subjects receiving DESyne Novolimus Eluting CSS|
16120214|NCT02009943|Drug|Ferric carboxymaltose|One time dosing
16120215|NCT02009943|Drug|Iron sucrose|Goal-directed dosing
16120216|NCT02009878|Drug|tolvaptan|Subjects will receive a single dose of 3.75, 7.5 or 15 mg of tolvaptan on study Day 1
16120217|NCT02009865|Drug|Epanova|Epanova will be provided in 1 g polyacrylate-coated soft gel capsules. Two capsules will be taken once per day, without regard to meals, for 12 weeks. At clinic visits, study drug will be administered at the clinic after fasting blood draws are complete.
16120218|NCT02009865|Drug|Olive Oil|Olive oil will be provided in 1 g polyacrylate-coated soft gel capsules. Two capsules will be taken once per day, without regard to meals, for 12 weeks. At clinic visits, study drug will be administered at the clinic after fasting blood draws are complete.
16120219|NCT02009839|Behavioral|Meeky Mouse program|
16120220|NCT02009839|Other|Computer Games|
16120221|NCT02009826|Radiation|[18F]-PBR111 Positron Emission Tomography (PET)|[18F]-PBR111 radioligand to assess binding to TSPO
16120222|NCT02009826|Behavioral|Cognitive and psychomotor tasks|Cognitive and psychomotor tasks on digitizing tablet
16120223|NCT02009826|Biological|Blood sampling|Blood sampling for peripheral inflammatory and neurotoxicity markers
16120224|NCT02009813|Procedure|Hyperbaric Oxygen Therapy|Participants will undergo 2 treatments of hyperbaric oxygen. Each treatment consists of 90 minutes compression at 2 atmospheres of pressure, with 30 minutes decompression back to 1 atmosphere. During this time, patients will be treated with 100% oxygen delivered via a hood system.
16120225|NCT02009800|Biological|Quadrivalent HPV vaccine|One dose of Gardasil administered in the intervention group
16120226|NCT02009787|Drug|vitamin D3 tablets|2000 IU vitamin D3 tablets were taken daily for 6 months
16120227|NCT02009787|Drug|placebo tablets|2000 IU placebo tablets were taken daily for 6 months
16120228|NCT02009774|Procedure|NBI Function|
16120229|NCT02009761|Drug|BI 655064|subcutaneous injection
16120230|NCT02009748|Dietary Supplement|Vitamin D supplementation|oral administration of colecalciferol 2.800 IU once daily
16120231|NCT02009748|Dietary Supplement|Placebo|oral administration of placebo (vehicle) once daily
16120232|NCT02009735|Device|virosensor|"virosensor, which was developed for the rapid and sensitive detection of viral antigen in medical samples, will be used for analyzing the interaction kinetics between anti-influenza-virus (or anti-EV71-virus) and its influenza virus antigen (or EV71 antigen) present in patients and normal samples.
~The system incorporates the use of chip formats. In antibody probing, antibodies are bound as a suitable probe, which specifically and selectively binds targeted molecules (virus antigen) in the test specimens."
16120233|NCT02009722|Drug|Morphine|Duramorph is administered as part of spinal anesthesia for post-operative pain relief.
16120235|NCT02009709|Drug|Riboflavin 0.1% ophthalmic solution|Instillation of 0.1% riboflavin ophthalmic solution, one drop every 3 minutes for 30 minutes before the procedure and one drop every 3 minutes during the procedure.
16120236|NCT02009709|Device|CCL-VARIO UV lamp|Application of ultraviolet light on the eye to be treated at an irradiance of 9 mW/cm2 for 10 minutes
16120237|NCT02009709|Device|CCL-VARIO at 18 mW/cm2|Application of ultraviolet light on the eye to be treated at an irradiance of 18 mW/cm2 for 5 minutes.
16120238|NCT02009696|Device|Patients with a ProMRI Pacemaker System|Bradycardia Slow Heart Beat
16120239|NCT02009696|Other|Magnetic Resonance Imaging (MRI) scan|MRI scan of heart/chest or thoracic spine.
16120240|NCT02009670|Dietary Supplement|13C inulin|Oral 13C inulin
16120241|NCT02009670|Other|Placebo|Oral maltodextrin
16120242|NCT02009644|Device|Subjects who receive the Treovance stent-graft|Eligible subjects will be implanted with the Treovance Stent-Graft
16120243|NCT02009631|Drug|Veliparib (ABT-888)|
16120244|NCT02009631|Drug|Placebo|
16120245|NCT02009618|Drug|Rifaximin|Rifaximin tablet is given as 200 mg 3x2/daily, for 10 days.
16120246|NCT02009618|Drug|placebo|
16120247|NCT02009605|Drug|Icotinib|125mg, oral administration, three times per day.
16120248|NCT02009592|Drug|Rifaximin|Both arms receive Rifaximin
16120249|NCT02009579|Drug|Nintedanib|Subjects will receive 6 cycles of 3-weekly carboplatin (AUC 5) + paclitaxel (175 mg/m2) and Nintedanib 200 mg BID followed by Nintedanib maintenance until progression or for a total maximum duration of 120 weeks.
16120250|NCT02009579|Drug|Placebo|Subjects will receive 6 cycles of 3-weekly carboplatin (AUC 5) + paclitaxel (175 mg/m2) and placebo 200 mg BID followed by placebo maintenance until progression or for a total maximum duration of 120 weeks.
16120251|NCT02009566|Radiation|Abdominal radiographs with microfabricated tags|Subjects will have 2 x-rays of their lower thorax/ abdomen taken. For each x-ray, a microfabricated tag or no tag will be placed in a different position. The x-rays will take approximately 15 minutes to complete.
16120252|NCT02009553|Other|Information sheet|
16120253|NCT02009553|Other|No information sheet|
16120254|NCT02009540|Drug|Botulinum toxin injected to bladder body|arm will receive 100u of onaBoNT-A in 20x1ml aliquots (5u/ml). 20 injections will be given into the bladder wall, sparing the trigone. Injections will be given through all layers of the bladder eg suburothelially and intradetrusor. The intervention will be performed under local anaesthetic using a flexible cystoscope.
16120255|NCT02009540|Drug|Botulinum toxin injected into trigone|Arm B will receive 100u onaBoNT-A injected into 10x1ml suburothelial peri-trigonal sites (aliquot dose 10u/ml). The procedure will be performed under local anaesthetic by flexible cystoscopy.
16120256|NCT02009527|Drug|N-hydroxy-nor-arginine|
16120257|NCT02009527|Drug|NaCl|
16120258|NCT02009514|Other|Glucose-containing compared to glucose-free hemodialysate|Comparison of effects on glucose variation
16120259|NCT02009501|Device|VAC VeraFlo with Dakins Instillation|VAC VeraFlo with Dakins instillation will be placed in the operating room after surgical debridement. Biopsies will be obtained prior to surgical debridement, after surgical debridement, on day 4, and on day 7.
16120260|NCT02009501|Device|VAC Ulta Therapy|VAC ULTA will be placed in the operating room after surgical debridement. Biopsies will be obtained prior to surgical debridement, after surgical debridement, on day 4, and on day 7.
16120261|NCT02009488|Drug|Canagliflozin, 100 mg|One 100 mg capsule taken orally (by mouth) once daily
16120262|NCT02009488|Drug|Canagliflozin, 300 mg|One 300 mg capsule taken orally (by mouth) once daily
16120263|NCT02009488|Drug|Placebo|One placebo capsule (inactive medication) once daily.
16120264|NCT02009475|Other|Interval exercise training|
16120265|NCT02009475|Other|Continues aerobic training|
16120266|NCT02009462|Drug|Artefill dermal filler|Four treatment visits will be scheduled at baseline and at weeks 4, 12, and 24. Each treatment session will utilize no more than 8 mL of Artefill and no more than 30 syringes of Artefill.
16120267|NCT02009449|Drug|Pegilodecakin|Daily subcutaneous injections of pegilodecakin up to 12 months
16120268|NCT02009449|Drug|Paclitaxel or Docetaxel and Carboplatin or Cisplatin|Day 1 of every 21 day cycle
16120269|NCT02009449|Drug|FOLFOX (Oxaliplatin/Leucovorin/5-Fluorouracil)|Intravenous administration on Day 1 and 2 of every 14 day cycle
16120270|NCT02009449|Drug|gemcitabine/nab-paclitaxel|Intravenous administration of the gemcitabine/nab-paclitaxel regimen on Day 1, 8 and 15 of each 28 day treatment cycle.
16120271|NCT02009449|Drug|Capecitabine|Capecitabine will be administered orally twice daily for 14 days out of every 21 days.
16120272|NCT02009449|Drug|Pazopanib|Pazopanib will be administered orally daily continuously
16120273|NCT02009449|Drug|Pembrolizumab|Pembrolizumab will be administered intravenously on Day 1 of every 21 day cycle.
16120274|NCT02009449|Drug|Paclitaxel|"Paclitaxel will be administered intravenously on Days 1, 8, 15 of each cycle (28 days= 1 cycle)
~• Paclitaxel 80 mg/ m2 IV"
16120275|NCT02009449|Drug|nivolumab|Nivolumab on Day 1 of each cycle (14 days = 1 cycle)
16120276|NCT02009449|Drug|Gemcitabine/carboplatin|gemcitabine and carboplatin on Days 1, 8 of each cycle (21 days = 1 cycle)
16120277|NCT02009436|Drug|Azacitidine|Given via nebulizer
16120278|NCT02009436|Other|Laboratory Biomarker Analysis|Correlative studies
16120279|NCT02009436|Other|Pharmacological Study|Correlative studies
16120280|NCT02009423|Drug|Masitinib|
16120281|NCT02009423|Drug|Placebo|
16120282|NCT02009410|Drug|Creon|Creon 25000 (2 capsules per meal 3 times per day and 1 capsule/snack 2 times per day) during 12 weeks
16120283|NCT02009410|Drug|Creon 25000 matching Placebo|Creon 25000 placebo matching capsules (2 capsules per meal 3 times per day and 1 capsule/snack 2 times per day) during 12 weeks
16120284|NCT02009397|Drug|Ipilimumab|
16120285|NCT02009397|Drug|GM-CSF|
16120287|NCT02009371|Device|Bright Light therapy|In this group, participants will be exposed to the LED treatment device (lightbox) which delivers bright light and meanwhile medicated with just one particular antipsychotics drug(a mood stabilizer or an atypical antipsychotic drug)except of antidepressants.
16120359|NCT02008786|Drug|placebo|Placebo
16122280|NCT01993589|Drug|comparison of pain relievers during curattage|
16120288|NCT02009371|Device|dim Red Light therapy|In this group, participants will be exposed to the same LED treatment device (light box) which delivers dim red light,which is considered to be biologically inactive, and meanwhile medicated with just one particular antipsychotics drug(a mood stabilizer or an atypical antipsychotic drug)except of antidepressants.
16120289|NCT02009358|Other|mental health promotion|
16120290|NCT02009332|Drug|ABI-009|ABI-009 is a nanoparticle albumin-bound (nab®) formulation of the mammalian Target of Rapamycin ( mTOR) inhibitor, sirolimus. Specifically, ABI-009 is a sterile lyophilized powder of albumin-bound sirolimus nanoparticles with a mean particle size of less than 100 nm.
16120291|NCT02009332|Drug|Gemcitabine|Gemcitabine is administered after ABI-009 in the Phase 2 study.
16120292|NCT02009306|Drug|PecFent and Epistatus|"PecFent will be supplied by Archimedes Pharma as two strengths of nasal spray solution at 1000 or 4000 mcg/mL fentanyl (as citrate). One spray contains 100 mcg or 400 mcg fentanyl (as citrate). Each bottle contains 1.55 ml ensuring delivery of 8 sprays of 100 or 400 mcg fentanyl (as citrate). PecFent is a commercially available product and packaging will be in accordance with the manufacturing authorisations (EU/1/10/644/001, EU/1/10/644/002, EU/1/10/644/005, EU/1/10/644/003, EU/1/10/644/004, EU/1/10/644/006).
~Epistatus will be supplied by Special Products Ltd. as buccal solution, packed in bottles containing solution for up to 4 x 1 ml doses, as per Specials licence. A pack also includes 4 x oral syringes used to administer the solution to the buccal cavity on either side of the mouth."
16120293|NCT02009306|Drug|Standard subcutaneous medication|"Subcutaneous as needed medication will include:
~Opioids for pain or dyspnoea
~Diamorphine
~Oxycodone
~Fentanyl
~Benzodiazepine and / or anti-psychotic for agitation
~Midazolam
~Levomepromazine
~Haloperidol Anti-emetic for nausea
~Cyclizine
~Metoclopramide
~Haloperidol
~Levomepromazine
~Anti-secretory drug for respiratory secretions
~Glycopyrronium
~Hyoscine butylbromide
~Hyoscine hydrobromide"
16120294|NCT02009306|Drug|Epistatus Alone|"Epistatus will be supplied by Special Products Ltd. as buccal solution, packed in bottles containing solution for up to 4 x 1 ml doses, as per Specials licence. A pack also includes 4 x oral syringes used to administer the solution to the buccal cavity on either side of the mouth."
16120295|NCT02009293|Other|Cough monitor|questionnaires about cough and quality of life
16120296|NCT02009280|Drug|Administration of anesthesia: Propofol|Maintenance of anesthesia with the propofol
16120297|NCT02009280|Drug|Administration of anesthesia: Sevoflurane|Maintenance of anesthesia with the sevoflurane
16120298|NCT02009267|Device|Patient controlled analgesia|A programable electronically controlled infusion pump that delivers an amount of intravenous analgesic when the patient presses a button.
16120299|NCT02009267|Procedure|Continuous thoracic epidural infusions|Continuous thoracic epidural infusions (TE) involves continuous infusion of drugs through a catheter placed into the epidural space, resulting in a loss of sensation-including the sensation of pain-by blocking the transmission of signals through nerve fibers in or near the spinal cord.
16120300|NCT02009267|Procedure|Continuous paravertebral blockade|Continuous paravertebral blockade (PVB) is the technique of injecting local anesthetic adjacent to the thoracic vertebra that anesthetizes the spinal nerve roots after they exit the spinal canal.
16120301|NCT02009254|Other|Dietary treatment|
16120302|NCT02009241|Other|Pulmonary Rehabilitation|
16120303|NCT02009228|Procedure|Ovarian cystectomy|
16120304|NCT02009215|Drug|Dihydroartemisinin-piperaquine (DP)|Intermittent preventive treatment (IPT) with dihyroartemisinin-piperaquine (DP) will be delivered to participating students monthly, for up to 6 rounds of treatment during one school year. DP will be given once a day for 3 days, using full strength tablets (40/320mg) according to weight-based guidelines. Treatment will be directly observed, and will not be blinded.
16120305|NCT02009202|Drug|polyethylene glycol|
16120306|NCT02009202|Drug|picosulphate|
16120307|NCT02009189|Drug|2% Taurolidine Lock|Catheter lock with 2% Taurolidine
16120308|NCT02009189|Drug|1.35% Taurolidine|Catheter lock with 1.35% Taurolidine + citrate
16120309|NCT02009176|Procedure|Laparoscopic Anatomical Hepatectomy|We let the 110 patients divide into A, B groups randomly who are meet the inclusion criteria .Group A is Laparoscopic Anatomical Hepatectomy: Anatomy the corresponding liver segment pedicle and hepatectomy along the Glisson fiber sheath
16120310|NCT02009176|Procedure|Laparoscopic Aon-anatomical Hepatectomy|We let the 110 patients divide into A, B groups randomly who are meet the inclusion criteria .Group B is Laparoscopic Aon-anatomical Hepatectomy:1 to 2 cm along the edge of the tumor complete hepatectomy
16120311|NCT02009163|Drug|Lisdexamfetamine dimesylate|SDP489 30, 50, or 70mg capsule once per day (open-label and double-blind periods)
16120312|NCT02009163|Other|Placebo|Placebo capsule once per day (double-blind period)
16120313|NCT02009137|Device|EVERA|EVERA apply for 12 weeks
16120314|NCT02009137|Device|ESTES|ESTES apply for 12 weeks
16120315|NCT02009124|Biological|Autologous bone marrow mononuclear cell transplantation|Bone marrow is aspirated by a standard procedure. Mononuclear cells are separated by density gradient method and then injected intrathecally by a standard lumbar puncture procedure
16120316|NCT02009111|Behavioral|Couple CARE for Parents|Couple CARE for Parents is a skill-based relationship enhancement program based on a self-regulatory model. It consists of seven sessions and two follow-up booster sessions that occur over the baby's first eight months of life. The first home visit is scheduled 7 - 14 days following recruitment. The next two sessions are scheduled in two week intervals. Sessions 4 through 7 are scheduled in three week intervals. Home visits are expected to last 1.5 to 2 hrs. Out-of-session viewing of the video and completing the exercises typically requires 45 min to 1 hr. The typical phone consultation lasts 15- to 30- min per person. Thus, the program lasts a minimum of 8 to 12 hours. The program will also include two booster sessions (beyond the 8 - 12 hrs).
16120317|NCT02009098|Drug|Cefuroxime|iv Cefuroxime 1,5g administered 15-60 minutes before incision versus iv Cefuroxime 1,5g administered after umbilical cord clamping
16120318|NCT02009072|Procedure|Sutureless and glue free limbal conjunctival autograft|Simple pterygium excision under local anesthesia was performed then closure of the bare sclera by sutureless and glue free conjunctival autograft in 50 eyes of 50 patients (group 1)
16120319|NCT02009072|Procedure|Sutured limbal conjunctival autograft|Simple pterygium excision under local anesthesia was performed then closure of the bare sclera by sutured limbal conjunctival autograft in 100 eyes of 100 patients (group 2).
16120360|NCT02008773|Drug|Valacyclovir HCI 500 mg tablets|Valacyclovir HCI 500 mg capsules 6/day oral for 16 weeks
16120321|NCT02009046|Behavioral|SEI Classroom Curriculum|Participants receive the 12-session Sexuality Education Initiative (SEI) classroom curriculum. The SEI classroom curriculum covers anatomy, abstinence, contraception and protection, STIs and HIV/AIDS, media messages, gender, relationships, rights and responsibilities, pregnancy, sexuality, peer pressure, negotiation and coercion, and decision making. These sessions are delivered over a two-month period. Each curriculum session is about 45 minutes in length.
16120322|NCT02009046|Behavioral|Control Classroom Curriculum|Participants receive the 3-session basic control curriculum. The control curriculum includes 3 sessions on sexually transmitted infections, anatomy and birth control delivered over a two- or three-week period. Each curriculum session is about 45 minutes in length.
16120323|NCT02009046|Behavioral|SEI Curriculum + 3 School Components|Participants receive SEI classroom curriculum and all three school wide components. The peer education/advocacy component recruits, trains and supervises students through an after-school leadership program to serve as resources to peers, organize health events, and refer students to school-based clinic services. The parent education component provides sessions for parents of students, covering reproductive health, teen pregnancy, and parent-teen communication, together with a parent education booklet for widespread use. The clinical services linkages includes health services on campus, including pregnancy/STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It includes training for teachers and staff to distribute condoms as needed.
16120324|NCT02009046|Behavioral|Control Curriculum + 1 School Component|Participants receive control classroom curriculum and one of the three school wide components, the clinical services linkages. This component includes health services on campus for students, including pregnancy and STI testing, contraceptive consultation and prescriptions, condom distribution, counseling, and referrals. It also includes training for teachers and school staff to distribute condoms to students as needed.
16120325|NCT02009033|Drug|Lactated Ringer|When normovolæmic status of the patient is secured, 35 ml/kg of the allocated fluid is infused during the operation (estimated time for this type of operation is 180 minutes), however max. 3500 ml.Lactated Ringer is the interventional medication.
16120326|NCT02009033|Drug|Hydroxyethylstarch|
16120327|NCT02009007|Drug|dopamine|continuous infusion during operation
16120328|NCT02009007|Drug|phenylephrine|continuous infusion of phenylephrine during operation
16120329|NCT02008994|Other|Genomic and Proteomic Profiling|Following review of targets by the Treatment Selection Committee, the treating physician will decide whether to continue with planned therapy or alter the course of treatment based on the genomic results.
16120330|NCT02008981|Drug|Curcuma longa|Curcuma longa in capsule form will be given with actual or placebo aspirin, each for a 3 week period. Clotting profile and platelet function test will be done before and after.
16120331|NCT02008981|Drug|Angelica sinensis|Angelicae sinensis in capsule form will be given with actual or placebo aspirin, each for a 3 week period. Clotting profile and platelet function test will be done before and after.
16120332|NCT02008981|Drug|Siwu Tang|"TCM formulation Siwu Tang consisting of 4 herbs ( Ligustici chuangxiong, Angelicae sinensis, Rehmanniae praeparata and Paeoniae alba) in tablet form will be given with actual or placebo aspirin, each for a 3 week period. Clotting profile and platelet function test will be done before and after."
16120333|NCT02008981|Drug|Aspirin|Aspirin (enteric-coated) at 100mg daily will be given one of the actual herb or placebo herb, each for a 3 week period. Clotting profile and platelet function test will be done before and after.
16120334|NCT02008968|Drug|allopurinol 300 mg./day|
16120335|NCT02008968|Other|No intervention|
16120336|NCT02008968|Drug|Normouricemic|
16120337|NCT02008955|Dietary Supplement|Lysine intake provided as a milkshake|There are 7 different lysine test levels ranging from 10 to 80 mg of lysine per kilogram body weight per day (10 - 80 mg/kg/d)
16120338|NCT02008942|Drug|PL2200 Aspirin Capsules|325 mg aspirin; once per day for 10 days
16120339|NCT02008942|Drug|Enteric-coated aspirin caplets|325 mg aspirin; once per day for 10 days
16120340|NCT02008929|Biological|MG4101|Ex vivo expanded allogeneic NK cell
16120341|NCT02008916|Drug|Secukinumab|AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL-17).
16120342|NCT02008916|Drug|Placebo secukinumab|Placebo to AIN457 (Secukinumab)
16120343|NCT02008890|Biological|Secukinumab 300mg|Secukinumab was used as 150 mg pre-filled syringes (PFS) in a double-blinded fashion. Secukinumab 300 mg s.c. (two PFS injections of the 150 mg dose) self-administered
16120344|NCT02008890|Biological|Secukinumab 150mg|secukinumab 150 mg s.c. (one PFS injection of the 150 mg dose + one PFS injection of placebo) self-administered
16120345|NCT02008890|Biological|Placebo|secukinumab placebo s.c. (two PFS injections of placebo) self-administered
16120346|NCT02008877|Drug|ganetespib|Phase 1 Dose 1: 150 mg/m² IV on days 1, 8, and 15 intravenously over 1 hour; Phase 1 Dose 2: 200 mg/m² IV on days 1, 8, and 15 intravenously over 1 hour; Phase 2: 200 mg/m² IV on days 1, 8, and 15 intravenously over 1 hour
16120347|NCT02008877|Drug|Sirolimus|4mg taken orally once daily on a continuous dosing schedule; Loading dose 12 mg on cycle 1 day 1 only.
16120348|NCT02008864|Drug|Senna|(7.5 mg of sennosoides A and B) Senna tablet/ 2 times per day
16120349|NCT02008864|Drug|Placebo|Placebo tablet/ 2 times per day
16120350|NCT02008851|Biological|Neo-kidney augment|Injection of 3.0 x 10e6 selected renal cells into the left kidney of the patient
16120351|NCT02008838|Dietary Supplement|Synbiotic|
16120352|NCT02008838|Dietary Supplement|Placebo|
16120353|NCT02008825|Device|Utilization of ViSiGi calibration tube|Utilization of ViSiGi calibration tube
16120354|NCT02008825|Device|Usual non suction Bougie|Usual non suction Bougie
16120355|NCT02008812|Device|Ad sensor|"Ad sensor, which was developed for the rapid and sensitive detection of viral antigen in medical samples, will be used for analyzing the interaction kinetics between anti-Adenovirus and its Adenovirus antigen present in patients and normal samples.
~The system incorporates the use of chip formats. In antibody probing, antibodies are bound as a suitable probe, which specifically and selectively binds targeted molecules (virus antigen) in the test specimens."
16120356|NCT02008799|Procedure|Bone marrow stem cell injection|Injection should be in testis and testicular artery
16120357|NCT02008786|Drug|ramipril|5-10mg (starting dose 5mg titrating up to 10mg if tolerated after 1 week)
16120358|NCT02008786|Drug|rosuvastatin|10-20mg (suggested dose 10mg for Asians, 20mg for everyone else)
16120363|NCT02008747|Drug|Magnesium sulphate|Continuous application of magnesium sulphate applied 40 mg/kg ideal body weight by bolus before the operation started, followed by a continuous infusion of 10 mg/kg ideal body weight/h for 24 hours
16120364|NCT02008734|Drug|PD0332991|
16120365|NCT02008721|Drug|EGCG as putative neuroprotective agent|Treatment with 800 mg - 1200 mg EGCG as putative neuroprotective agent
16120366|NCT02008721|Drug|Placebo|Placebo
16120367|NCT02008708|Behavioral|Livestock Microfinance|Participants randomized to the microfinance group receive the pig loan.
16120368|NCT02008708|Other|Delayed Control Group|Participants enrolled in delayed control receive their pig loan 12 months after the intervention group.
16120369|NCT02008695|Behavioral|adult microfinance|"Female piglet provided to household member. Participants agrees to repay participants' loan by giving two piglets (one to repay the loan and one for the interest on the loan) to the association from the first litter of piglets (on average 6-12 piglets). These piglets are then given to other village member households"
16120370|NCT02008695|Behavioral|Youth microfinance only|One child (10-15 years) receive rabbits loan. The child is mentored by microfinance and community mentors. The child repays the loan to program and other children in the family and community are provided a loan from the repayment.
16120371|NCT02008695|Behavioral|youth and adult micro finance|One child and adult member of household receive animal loan. The child and adult are mentored and repayment of the loan to the program is provided and the repayment animal is provided to other members of the community
16120372|NCT02008682|Drug|liraglutide|Administered subcutaneously (s.c., under the skin) once daily as add-on to the subject's stable pre-trial metformin dose.
16120373|NCT02008682|Drug|sitagliptin|Administered orally once daily as add-on to the subject's stable pre-trial metformin dose.
16120374|NCT02008669|Procedure|Blood sampling|A blood sample will be taken from each patient and the following parameters will be assessed : magnesium, albumin, Vitamin B12, Vitamin D, Calcium, Iron.
16120375|NCT02008669|Other|Gustatory sensitivity test using Taste strips|"16 Taste Strips impregnated with 4 flavors (sweet, sour, salty, bitter, each flavor present at 4 different concentrations), are offered to the patient one after the other in a so-called pseudorandomized sequence. The task of the patient is to choose one of the following answers: sweet / sour / salty / bitter / no taste.
~Each correct answer is granted one point. In addition to the impregnated strips, two tasteless strips can be integrated in the examination at any point of time (no point)"
16120376|NCT02008669|Other|Questionnaires|"Evaluation of the following parameters by validated questionnaires (name of the questionnaire in bracket):
~Fatigue (EMIF-SEP)
~Dysphagia (DYMUS)
~Food intake (semi-structured questionnaire)
~Depression (BDI-II)
~Daily energy expenditure (NAP)
~Visual analog scale to study quality of sleep"
16120377|NCT02008656|Drug|Oxaliplatin (OXAL)|
16120378|NCT02008656|Drug|5-Fluorouracil (5-FU)|
16120379|NCT02008656|Drug|Leucovorin|
16120380|NCT02008656|Drug|Capecitabine (Xeloda®)|
16120381|NCT02008656|Radiation|intensity modulated radiotherapy (IMRT)|
16120382|NCT02008656|Behavioral|Quality of Life Questionnaires|
16120383|NCT02008656|Procedure|DRE-Endoscopy|
16120384|NCT02008643|Other|filling questionnary to quality of life|filling questionnary to quality of life
16120385|NCT02008630|Other|Animal-assisted activity|
16120386|NCT02008630|Other|Animal-assisted therapy|
16120387|NCT02008617|Drug|Bupivacaine|30mL of Bupivicaine 0.20% with epinephrine 1:300,000
16120388|NCT02008617|Drug|Preservative free normal saline|Ultrasound guided posterior genicular nerve infiltration posterior knee with 30mL of preservative free normal saline
16120389|NCT02008591|Procedure|Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique|Three different techniques, using the same medications (bupivacaine and fentanyl)
16120390|NCT02008578|Biological|Intravenous hyperimmune immunoglobulin (Flu-IVIG)|
16120391|NCT02008578|Biological|Placebo|
16120392|NCT02008565|Drug|Loperamide|Participants randomized to the loperamide group will begin with 2mg of loperamide/day. The participant will be administered the Patient Global Symptom Control rating scale (PGSC) to determine dose escalation. Participants who report inadequate control of stool leakage on the PGSC will be instructed to increase the daily dose of loperamide by 2 mg up to a maximum of 8 mg per day (1-4 capsules). Bothersome adverse events and resulting dose reduction will be based exclusively on the result of the Patient Global Tolerability Scale (PGTS). The daily dose will be decreased by 2mg to a minimum of 2mg every other day. If a PGSC score indicates inadequate control of stool leakage combined with a PGTS score indicating bothersome side effects, the participant will discontinue the study medication.
16120393|NCT02008565|Drug|Placebo|Participants randomized to the placebo arm will begin the a dose of one capsule per day and will be dose increased or dose decreased using the same algorithm described for the loperamide arm.
16120394|NCT02008565|Behavioral|Anal exercises with biofeedback|Participants will receive a formal anal exercises training program that can be easily applied in an office setting with minimal participant burden. Participants will attend six anal exercises with biofeedback sessions with trained personnel over a 12-week period for the 24-week study. Sessions will include introduction, standard patient education, and exercises using anal manometry-assisted biofeedback introducing concepts such as shaping, generalization and termination. The protocol uses strength and sensory training including urge resistance training. During the final twelve weeks, participants will perform anal exercises on their own. The sessions with interventionists will occur every other week for 12 weeks (total 6 supervised sessions).
16120395|NCT02008565|Behavioral|Usual Care|Usual care consists of patients receiving an educational pamphlet on fecal incontinence created by the National Institute of Diabetes and Digestive and Kidney Diseases.
16120396|NCT02008552|Genetic|Sampling of blood|Sampling of blood was taken and analyse to research factor genetic
16120397|NCT02008539|Drug|MSC_apceth_101|
16120398|NCT02008526|Behavioral|Text Messages Transmitted by Peer Health Educators (TXT-PHE)|"Participants receive five gay-specific, theory-based pre-written messages per day sent on a predetermined schedule. Participants who respond to the pre-written text messages or initiate queries or requests for support (pull) are sent additional real-time messages back from the PHE. Text messages are transmitted and responded to in real time, at the peak hours of high-risk activities. During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days."
16120399|NCT02008526|Behavioral|Text Messages Transmitted by Automation (TXT-Auto)|Participants receive five gay-specific, theory-based pre-written messages per day sent on a predetermined schedule. During the 8-week intervention, participants receive a brief weekly text-based assessment on their methamphetamine use and HIV sexual behaviors in the previous seven days.
16120400|NCT02008513|Biological|AFFITOPE® AD02|
16120401|NCT02008513|Biological|Placebo|
16120402|NCT02008500|Other|placebo mouthwash|15 ml placebo mouthwash prescribed and VAS score assessed at Baseline, 3 weeks, 6 weeks and 12 weeks
16120403|NCT02008500|Other|Herbal Mouthwash|15 ml Herbal mouthwash prescribed and VAS score assessed at Baseline, 3 weeks, 6 weeks and 12 weeks
16120404|NCT02008500|Other|Non Herbal Mouthwash|15 ml Non Herbal mouthwash prescribed and VAS score assessed at Baseline, 3 weeks, 6 weeks and 12 weeks
16120405|NCT02008487|Other|Wound powder application|Powder application to wound per protocol.
16120406|NCT02008474|Behavioral|Online weight loss + incentives for behavior 3 months|Participants will receive monetary incentives for submitting their behavior change information into a study website
16120407|NCT02008474|Behavioral|Online weight loss + incentives for weight loss at month 3|Participants will receive an incentive for meeting their weight loss goal at month 3.
16120408|NCT02008474|Behavioral|Online weight loss + Incentives for behavior 12 months|Participants will receive incentives for submitting behavior change information over the course of 12 months.
16120409|NCT02008474|Behavioral|Online weight loss + Incentives for weight loss 12 months|Participants will be receive monetary incentives for reaching their weight loss goal at months 3 and 12.
16120410|NCT02008461|Procedure|radiofrequency ablation|
16120411|NCT02008461|Drug|botulinum toxin injection|
16120412|NCT02008448|Procedure|Pulmonary vein isolation|
16120413|NCT02008448|Procedure|Linear Lesion Ablation|
16120414|NCT02008448|Drug|BT injection|
16120415|NCT02008435|Behavioral|Enriched GLB|Habit formation techniques, namely if-then plans and their mental practice are being added to the standard Group Lifestyle Balance program.
16120416|NCT02008435|Behavioral|Standard GLB|This arm is the standard Group Lifestyle Balance program
16120417|NCT02008422|Drug|Oxaliplatin|130mg/m2 , iv, 3-4h, d1, 21 d as a cycle.
16120418|NCT02008422|Drug|Gimeracil and Oteracil Potassium Capsule|40 mg/m2, po., Bid., d1-14, 21 d as a cycle.
16120419|NCT02008422|Drug|Endostar injection|7.5 mg/m2/d, 2 mL/h continuous pumping into vein, d1-10, 21 d as a cycle.
16120420|NCT02008409|Device|EndoLift Liver Retractor|"During the surgery, the surgeon will use the new internal liver retractor device. The device will retract the liver out of the way and help the surgeon see better during the surgery. The device is placed inside the abdomen during the surgery. It is clipped onto 2 safe surfaces inside the abdomen. The device is removed before the surgery ends."
16120421|NCT02008396|Drug|Placebo|Subjects will receive capsules of lactose of identical appearance to MDMA capsules during each of two experimental sessions. Capsules will be administered along with psychotherapy.
16120422|NCT02008396|Drug|75 mg to 125 mg MDMA|Participants receive a capsule of 75 or 100 mg during the first of two experimental sessions and a capsule of 100 or 125 mg MDMA during the second experimental session. They will receive MDMA with psychotherapy.
16120423|NCT02008396|Behavioral|Psychotherapy|Psychotherapy conducted throughout experimental sessions. Therapists will use a largely nondirective approach. There will be periods of structured and unstructured interactions. The structured interactions will be selected based on elements of therapeutic interventions that are currently in use in this population for the treatment of social anxiety.
16120424|NCT02008383|Biological|Panitumumab|The FDA approved dose for panitumumab is 6mg/kg IV, every two weeks. This is the dose and schedule that will be used in this study.
16120425|NCT02008383|Drug|Cabozantinib|"There will be three parts to this phase I study: 1) the Combination Dose Finding cohort; 2) the Combination Expansion cohort; and 3) the Monotherapy MET Amplified cohort.
~Cabozantinib will start at a dose of 60 mg daily with reductions to 40 and 20 mg daily possible in the dose finding cohort. The combination expansion cohort dose will determined by the dose finding cohort. The Monotherapy MET Amplified cohort will recieve 60 mg Cabozantinib daily."
16120426|NCT02008370|Drug|Exparel infiltration|Exparel infiltrated into wound and chest tube sites
16120429|NCT02008344|Drug|favipiravir|"Administered twice daily over 5 consecutive days for a total of 10 doses.
~Day 1: 1800 mg twice daily (loading doses)
~Days 2 through 5: 800 mg twice daily"
16120430|NCT02008344|Drug|placebo|"Administered twice daily over 5 consecutive days for a total of 10 doses.
~Day 1: 1800 mg twice daily (loading doses)
~Days 2 through 5: 800 mg twice daily"
16120431|NCT02008331|Dietary Supplement|SYNBIOTIC|"INTERVENTION: Probinul neutro® assumed three times a day far from meals as 5 g powder packets dissolved in water. Probinul neutro® contains 5×109 Lactobacillus plantarum, 2×109 Lactobacillus casei subp. rhamnosus and 2×109 Lactobacillus gasseri, 1×109 Bifidobacterium infantis and 1×109 Bifidobacterium longum, 1×109 Lactobacillus acidophilus, 1×109 Lactobacillus salivarus and 1×109 Lactobacillus sporogenes and 5×109 Streptococcus termophilus, prebiotic inulin (2.2 g; VB Beneo Synergy 1) and 1.3 g of tapioca-resistant starch.
~PLACEBO: Tapioca-resistant starch powder similar in colour, texture and taste to the symbiotic mixture, assumed three times a day far from meals as 5 g powder packets dissolved in water."
16120432|NCT02008318|Drug|Galunisertib|Administered orally
16120433|NCT02008318|Drug|Placebo|Administered orally
16120434|NCT02008305|Device|protocol of optimization ALARA|
16120435|NCT02008305|Device|protocol of optimization Philips|
16120437|NCT02008279|Biological|100 mg CNTO 3157|A single subcutaneous (SC) (under the skin) injection of 100 mg CNTO 3157
16120438|NCT02008279|Biological|300 mg CNTO 3157|2 SC injections of CNTO 3157 providing a total dose of 300 mg
16120439|NCT02008279|Biological|600 mg CNTO 3157|4 SC injections of CNTO 3157 providing a total dose of 600 mg
16120440|NCT02008279|Biological|300 mg CNTO 3157|300 mg of CNTO 3157 as an intravenous (IV) infusion (into a vein) administered over a period of 30 minutes
16120441|NCT02008279|Drug|Placebo|SC injections of placebo (number of injections to equal number of injections of CNTO 3157)
16120442|NCT02008253|Procedure|INTRASTROMAL CORNEAL RING SEGMENT|Corneal tunnels were created by means of mechanical dissection in all eyes. Main outcome measures included UCVA, BCVA, refraction, keratometry and computerized analysis of corneal topography.
16120443|NCT02008240|Procedure|Needle aspiration of hydrosalpinx|Under deep sedation, the retrieval of oocytes is done and then an aspiration needle is inserted into the hydrosalpinx under ultrasonographic guidance and suction is applied to aspirate the hydrosalpingeal fluid completely . If there are bilateral hydrosalpinges, the process is repeated on the opposite side.
16120444|NCT02008240|Procedure|Salpingectomy|laparoscopic surgical removal of affected tube is done with bipolar electrocoagulation for hemostasis. The mesosalpinx is coagulated as close a possible to the fallopian tube to avoid any compromise in the ovarian blood supply . In cases with marked adhesion, proximal ligation and a distal fenestration is done .
16120445|NCT02008227|Drug|Atezolizumab|1200 mg IV infusion on Day 1 of each 21-day cycle
16120446|NCT02008227|Drug|Docetaxel|75 mg/m^2 IV infusion on Day 1 of each 21-day cycle
16120447|NCT02008214|Drug|Pentoxifylline|Addition of pentoxifylline to current HCV treatment
16120448|NCT02008214|Drug|Placebo|Placebo matching pentoxifylline dosage
16120449|NCT02008201|Dietary Supplement|vitamin D|
16120450|NCT02008175|Radiation|Conventional CXL|Crosslinking was done according to the standard protocol using hypo-osmolar riboflavin (<0.1%) to saturate the cornea following epithelial debridement and ultra - violet light of 370nm with energy density of 3 milliwatts/cm2 with riboflavin and distilled water alternated every 2 minutes was used for the procedure..
16120451|NCT02008162|Drug|Bronchodilators|Administration of both albuterol and tiotropium bromide after a 48h period of washout from all bronchodilators, followed by spirometry and plethysmography
16120452|NCT02008149|Other|Rowing exercise|Individuals with SCI will use the rowing exerciser to see if there is a benefit to skeletal health in the lower limbs.
16120453|NCT02008136|Drug|Botulinum Toxins|intramuscular injections
16120454|NCT02008123|Drug|Primidone|Primidone is an antiepileptic used for the management of generalized tonic-clonic seizures and for the management of complex partial seizures. One of primidone's active metabolite is phenobarbital, which is a potent cytochrome P450 inducer. In this study, primidone will be used to induce CYP 1A2 in order to provide more efficient metabolism of clopidogrel to its active form
16120455|NCT02008110|Drug|CA125 guided strategy|Up titration of loop diuretics according to plasma levels of CA125 in the active arm
16120456|NCT02008110|Drug|CA125 guided strategy|Consider statins in all patients in the active arm
16120457|NCT02008110|Drug|CA125 guided strategy|Consider omega-3 polyunsaturated fatty acids in the active arm
16120458|NCT02008110|Other|CA125 guided strategy|Frequency of monitoring according plasma evolution of CA125 in the active arm.
16120459|NCT02008110|Drug|Standard treatment strategy|All patients should be treated following standard european guidelines regarding angiotensin converting enzyme inhibitors, angiotensin receptor blockers, beta-blockers, aldosterone antagonists, diuretics, ivabradine and other treatments such as (diet, anticoagulants, antiarrhythmics, statins, omega-3 polyunsaturated fatty acids, digoxin, nitrates and vasoactive group).
16120460|NCT02008110|Drug|CA125 guided strategy|All patients should be treated following standard european guidelines regarding angiotensin converting enzyme inhibitors, angiotensin receptor blockers, beta-blockers, ivabradine and other treatments such as (diet, anticoagulants, antiarrhythmics, digoxin, nitrates and vasoactive group).
16120461|NCT02008097|Device|GE LOGIQ E9 Ultrasound System|"Subjects will have an ultrasound exam using the GE LOGIQ E9 Ultrasound System which has computer software that combines the color-flow image and B-mode image to produce the new B-Flow method of ultrasound."
16120462|NCT02008084|Drug|TRIA-662|Following Baseline randomized to active TRIA-662 2 x 500 mg tablets, three times daily with meals for 2 weeks and then active TRIA-662 2 x 1000 mg tablets, three times daily with meals for 12 weeks.
16120463|NCT02008084|Drug|Placebo|Following Baseline randomized to placebo TRIA-662 2 x 500 mg tablets, three times daily with meals for 2 weeks and then placebo TRIA-662 2 x 1000 mg tablets, three times daily with meals for 12 weeks.
16120464|NCT02008071|Behavioral|Daily step goal financial incentive|Participants' daily activity was incentivized. Reaching a predetermined/individualized step goal each day resulted in 1.00 per day.
16120465|NCT02008071|Behavioral|Standard of Care|Standard payment of 70.00 at the beginning of the study. Participants' daily activity was not incentivized.
16120466|NCT02008058|Behavioral|Survey|Patients will report pain and analgesic use through the automated telephone system, for 7 days in a row, once every 6 weeks. Data from diagnostic tests (CT Abdomen/Pelvis, Bone Scan, PSA, and circulating tumor cells) conducted during the study period will be collected from medical records by local personnel and entered into the secure online database quarterly, but no specific tests or schedules will be required in this observational study. Patients will remain on study for up to 26 months (slightly longer than the expected median survival in this population based on data from docetaxel, abiraterone, and MDV3100 pivotal phase 3 trials).
16120467|NCT02008045|Device|Magnetic Resonance Imaging|Brain MRI without Contrast
16120468|NCT02008045|Behavioral|Neurodevelopmental Testing|Validated battery of neurodevelopmental and psychological tests.
16120469|NCT02008032|Device|Stationary Breast Tomosynthesis|The patient will have the SDBT study performed in a similar manner as conventional mammography in the mediolateral oblique and cranio-caudal plane. The participant will stand up and the mammography research technologist, ensuring patient comfort, will assist in positioning their breast in the breast tomosynthesis unit with standard compression. Once positioned, the total scan time is approximately 10 seconds. Both the left and right breast will be imaged. The length of time for the positioning and examination of a subject's breast may vary but it is expected that the entire imaging procedure will take about 5-10 min, including positioning time.
16120470|NCT02008019|Drug|Everolimus 2.5 mg/day|Comparison between 2,5 mg/day of Everolimus per os to 10 mg/day, or to no treatment, taken during 30 days before chondrosarcoma surgery
16120471|NCT02008019|Drug|Everolimus 10 mg/day|Comparison between 10 mg/day of Everolimus per os to 2.5 mg/day, or to no treatment taken during 30 days before chondrosarcoma surgery
16120472|NCT02008006|Drug|BeEAM|"High Dose Chemotherapy (HDT) containing :
~Bendamustine 160 mg/m2 for 2 days (D-8 and D-7)
~Etoposide 200 mg/m2 and Cytarabine 400 mg/m2 for 4 days (D-6 to D-3)
~Melphalan 140 mg/m2 on D-2
~HDT will be followed by an Autologous Stem Cell Transplantation on D0"
16122333|NCT01993212|Drug|Placebo Capsules|
16120473|NCT02007993|Other|PDT|"A single session of PDT will be performed with the Chimiolux® photosensitizer at a concentration of 0.005% applied over the middle and posterior thirds of the dorsum of the tongue.
~Nine points will be irradiated, the device will be previously calibrated with a wavelength of 660 nm, power of 100 mW, energy of 9 joules for 90 seconds per point in Groups 2 and 4 and 12 joules for 120 second per point in Groups 3 and 5"
16120474|NCT02007993|Other|Tongue Scraper|The pacient will scrap the tongue 10 times.
16120475|NCT02007954|Device|DEBDOX|DEBDOX, loaded with doxorubicin, is a device that utilizes beads in place of lipiodol to deliver the chemotherapy into the liver tumor. The device allows for continuous elution of doxorubicin into the liver tumor tissue. The advantages of this method of delivery in comparison to conventional TACE are that the beads are able to deliver a greater volume and concentration of the drugs to the tumor because of their unique ability to elute the drug over a period of several days. As a result of this unique delivery, systemic toxicity is significantly reduced. The potential advantages of the smaller beads are deeper penetration into the tumor bed, while avoiding premature proximal occlusion of vessels feeding the tumor, and more consistent dosing. These properties translate into greater potency of therapy and potentially improved patient survival.
16120476|NCT02007941|Drug|CKD-501|From day 1 to day 3, Once(Day1) CKD-501 0.5mg is administered .
16120477|NCT02007928|Other|Rispéridone, aripiprazole, olanzapine|"Study:
~We propose a prospective, interventional multicenter study.
~Method:
~Both in and out patients may be included in the study Patients will be recruited over a period of 24 months. They will be followed up for 12 months. Each patient will receive one year of therapeutic monitoring after the introduction of the antipsychotic drug.
~The therapeutic monitoring will include clinical, electrocardiographical, and laboratory assessments. These assessments are performed at baseline (before prescribing treatment) and at 1 month (M1), at 3 months (M3), 6 months (M6), 9 months (M9), and at 12 months (M12) after the first prescription of the antipsychotic drug."
16120478|NCT02007915|Drug|Pamidronate Disodium|Pamidronate will be given intravenously over one hour, one day per month for three out of every four months. The initial dose is 0.5mg/kg and subsequent doses are 1mg/kg. Infusions will continue for at least one year with a second year possibly recommended by the surgeon from data on the x-ray and bone scan.
16120479|NCT02007902|Other|Evaluation of the relationship plasma protein levels - neonatal hemodynamics|"Patient inclusion at birth
~Total plasma protein values measurement on cord blood sample at birth
~Hemodynamic evaluation at 6 hours after birth with colour doppler echocardiography and organ blood flow colour doppler
~Total plasma protein and albumin values measurement on plasma sample at 12 hours after birth
~Blood pressure, heart rate, O2 saturation, capillary refill time, rSO2 [regional (cerebral and somatic) tissue oxygenation by NIRS - near infrared spectroscopy] will be monitored over 24 hours after birth."
16120480|NCT02007889|Drug|L-carnitine|50 mg/kg/day carnitine in divided 2-3 times/day (maximum 3 g/day) in addition to antibiotic regimens
16120481|NCT02007876|Behavioral|Mobility and Activity Training|"Pre-operative: Transfer training: bed and chair transferring exercises rising with and without use of hand assistance including supine to sit in or to the side in bed, and sit to stand from a normal and low height chair. GCS exercises: 1) supine pelvic bracing with transverse abdominal recruitment 2) hip bridges with abductor squeeze 3) supine bent leg abduction with light theraband and 4) supine isometric core and pelvic stabilization with legs flexed and shoulder flexion to raise arms over head with advancement to using theraband. For patients able to stand safely 5) standing mini squats against the wall.
~Post-operative: Early mobilization to include standard physical therapy techniques to enhance bed mobility, facilitated sit to stand and walking with therapist assist as needed. All GCS exercises begin 24 hr post op with goal of 5-10 reps and progressing to 3 sets of 10 reps. Participants will be encouraged to move from a roll to the side first supine to sit strategy by week 2."
16120482|NCT02007863|Procedure|Umbilical Cord Blood Transfusion|Following the administration of the preparative therapy, all subjects will undergo UCB transplantation. Umbilical Cord Blood Transfusion will occur on Day 0
16120483|NCT02007863|Drug|Fludarabine|Fludarabine 25 mg/m2/day will be administered over 30-60 minutes intravenous infusion on Days -13 through -9 for a total of 5 doses. Fludarabine will not be dose adjusted for body weight.
16120484|NCT02007863|Drug|Busulfan|Busulfan IV (Busulfex) will be administered IV every 6 hours on days -8 through -5 for a total of 16 doses. Seizure prophylaxis prior to first dose of busulfan till Day -3 will be administered.
16120485|NCT02007863|Drug|Melphalan|Melphalan 45 mg/m2/day will be administered over 60 minutes intravenous infusion on Days -4 through -2 for a total of 3 doses.
16120486|NCT02007850|Drug|ropivacaine|Patients receive 15 ml of 0.25% ropivacaine pre-operatively through femoral block catheter, followed by 0.2% ropivacaine continuous mode or patient controlled mode for 2 days after surgery
16120487|NCT02007837|Drug|Combined aspirin and multinutrient supplement|Single capsule with 80mg low-dose aspirin, 1.2 grams calcium, 600 IU vitamin D, 5mg folic acid and 1000 ug vitamin B12 mixed.
16120488|NCT02007837|Other|Daily text reminder text messages|
16120489|NCT02007824|Device|ULSD-12D|wound cleansing and debridement using ULSD-12D
16120490|NCT02007824|Device|SONOCA-180|wound cleansing and debridement using SONOCA-180
16120491|NCT02007811|Biological|allogeneic donor derived B-lymphocytes|CD3+-depleted, CD19+-enriched, cryopreserved (single administration after day 120 following allogeneic stem cell transplantation, donor-identical) in 4 groups with escalating doses
16120492|NCT02007798|Drug|dexmedetomidine|2 ml of dexmedetomidine at a concentration of 100 ug/ml is diluted by 98 ml normal saline to a concentration of 2 ug/ml. The required amount of experimental drugs is confirmed according to the weight and grouping, and diluted using normal saline to 20 ml.
16120493|NCT02007798|Drug|normal saline|100 ml per bag
16120494|NCT02007785|Behavioral|CO-OP treatment protocol|Participants with Parkinson's disease will be participating in up to 12 one-on-one treatment sessions with 2 sessions per week, for up to 6 weeks. Each session will last 45-60 minutes. During these treatment sessions, each participant will be taught a problem-solving strategy that teaches individuals to monitor and adjust their own actions. Participants will be guided by the principal investigator to select 5 individual treatment goals to work on during treatment. Sessions will continue until all 5 treatment goals have been met or until 12 sessions have been completed, whichever occurs earlier. Initially, each participant's respective primary caregiver will be required to attend treatment sessions, so that the caregiver may be familiar with the treatment strategy in order to coach the participant with Parkinson's disease when you he or she uses the strategy at home.
16120496|NCT02007772|Device|BiPAP|BiPAP is used over a period of 6 weeks (outpatient)
16120497|NCT02007759|Device|VitalStim|This group will receive active VitalStim treatment.
16120498|NCT02007759|Device|Sham VitalStim|This group will receive a sham VitalStim intervention.
16120499|NCT02007746|Other|Liver transient elastography (Fibroscan)|Fibroscan will be performed as a measure of liver stiffness. The study will be obtained free of charge in this study.
16120500|NCT02007746|Other|Ferriscan|Ferriscan will be done to assess the quantity of liver iron in iron overloaded subjects.
16120501|NCT02007746|Procedure|Liver biopsy in iron overloaded subjects.|Liver biopsy will be done and the results will be compared to Fibroscan results.
16120502|NCT02007733|Other|Serial Weights|We will collect serial weights on all children enrolled in this study.
16120503|NCT02007733|Other|IVC/Aorta Ultrasound|We will perform an ultrasound assessment of the IVC and Aorta size in each child enrolled.
16120504|NCT02007733|Other|Clinical Assessment|We will perform a clinical assessment of dehydration status in each child enrolled in the study, as well as collect data on mid-upper arm circumference, length, symptoms and demographic information.
16120505|NCT02007720|Drug|Serelaxin|Intravenous infusion
16120506|NCT02007720|Drug|Placebo|Intravenous infusion
16120507|NCT02007720|Other|Standard of CareTherapy|This treatment can include but is not limited to intravenous and/or oral diuretics, ACE inhibitors/angiotensin receptor antagonists, β blockers, and aldosterone receptor antagonists, etc.
16120508|NCT02007707|Behavioral|Tobacco LHW|Quit Smoking For a Healthy Family - This is a family-based psycho-education intervention using lay health worker (LHW) outreach. LHW will be trained to recruit smoke-family dyads and provide education and information about tobacco and health, and smoking cessation resources through 2 small-group education sessions and 2 individual phone calls over a 2-month period.
16120509|NCT02007707|Behavioral|Healthy Eating|Eating Healthy and Physically Active for You and Your Family - This is a attention-control comparison group using a family-based psycho-education intervention delivered through lay health worker (LHW) outreach. LHW will be trained to recruit smoke-family dyads and provide education and information about healthy eating and physical activity through 2 small-group education sessions and 2 individual phone calls over a 2-month period. Participants will receive writing information about smoking cessation resources.
16120510|NCT02007694|Behavioral|Virtual Reality Exposure Therapy (VRET)|Graded exposure to feared specific stimulus by computer-generated 3D virtual environments.
16120511|NCT02007681|Behavioral|Reduction of sedentary time by breaking it with low intensity physical activity|One 5-10 minute break per hour during the work day using a software that alert the participant, and perform 6000 steps above the baseline number of steps/day (previously evaluated), by adopting several domain specific strategies, during 7 days.
16120512|NCT02007668|Other|Kinesio Taping|Kinesio taping intervention is based upon the use of specific elastic tapes (known as Kinesio Tex Gold) that are applied with a certain amount of tension fixed to the skin of patients with the target muscles in a stretched position. The tapes will be placed over the lumbar spine.
16120513|NCT02007655|Drug|Eliquis|
16120514|NCT02007642|Procedure|Blood sampling / Body fluid sampling|"During the hospitalization of the patient, when a sampling is done for classic follow-up and diagnosis, additionnal blood sampling will be done, for the PATHOQUEST method.
~Other body fluids might be taken (if the sampling is done for the classic follow-up), such as cerebrospinal fluid, ascite..."
16120515|NCT02007629|Drug|Riociguat (Adempas, BAY63-2521)|Riociguat / BAY63-2521 film-coated tablets will be used in this study at a dosage of either 0.5, 1.0, 1.5, 2.0, and 2.5 mg. 3 times daily
16120516|NCT02007616|Other|Non-action video game training|Based on cognitive training Lumosity
16120517|NCT02007603|Drug|Administration of Amoxicillin / clavulanic acid|Patients receive amoxicillin / clavulanic acid due to clinical necessity
16120518|NCT02007603|Drug|Ampicillin / sulbactam|Patients receive ampicillin / sulbactam due to clinical necessity
16120519|NCT02007603|Procedure|Blooddraws for pharmacokinetic profiling|Blood will be sampled at multiple timepoints during multiple hemodialysis sessions
16120520|NCT02007590|Device|Aerosure 25 Hz|Active Aerosure device
16120521|NCT02007590|Device|Aerosure Sham|Device designed to appear identical to active device but with HFAO mechanism disabled
16120522|NCT02007577|Drug|salsalate|Participants will take 3, 500 mg tablets with breakfast and 4, 500 mg tablets with dinner
16120523|NCT02007577|Drug|Placebo|Participants will take 3 tablets with breakfast and 4 tablets with dinner
16120524|NCT02007564|Behavioral|LIFE Intervention|RSVs received intensive training in the manualized intervention, including practice opportunities. The manual and accompanying workbook consist of instructions about using the steps of problem solving to decide on a period of life and creative activity project; constructing a project; evaluation of the activity; and additional questions. With the help of the RSV, dyads narrow the focus to one time period in the patients' life that could be adequately represented in one tangible project (scrapbook, audiotapes). The RSV and dyad brainstormed ways to portray the life story and then narrowed the focus to one meaningful project. The dyad gathered all necessary materials (such as pictures) and actively worked on completing a portion of the project between sessions.
16120525|NCT02007551|Behavioral|Mealtime Intervention|The mealtime intervention constitutes once a week visits from a trained volunteer for 8 weeks, each visit lasting 90 minutes and comprising of preparing and sharing a meal together with the participant.
16120526|NCT02007525|Behavioral|Yoga intervention|Participants will attend one weekly 60 minute hatha yoga class taught by a certified yoga instructor for 6 weeks. Each participant is to practice yoga at home 3-5 days per week. Paper logs will be provided to record date, time and duration of yoga practice each week.
16120527|NCT02007512|Drug|Enzalutamide|160 mg/day administered as four 40mg soft gelatin capsules by mouth once daily with or without food.
16120528|NCT02007512|Drug|exemestane|25mg (overencapsulated to match 50mg dose during the blinded portion of the study and one 25mg tablet after unblinding) by mouth once daily after food.
16120529|NCT02007512|Drug|Placebo (for enzalutamide)|Sugar pill manufactured to mimic enzalutamide administered as four soft gelatin capsules by mouth once daily with or without food.
16120530|NCT02007512|Drug|exemestane|50mg (two 25mg tablets overencapsulated as a single capsule during the blinded portion of the study and two 25mg tablets after unblinding) by mouth once daily after food.
16122334|NCT01993212|Drug|Placebo Gel|
16120531|NCT02007486|Other|Cardiopulmonary Exercise Testing|Symptom-limited incremental exercise testing (10 watts/min) on an electronically braked cycle ergometer
16120532|NCT02007460|Behavioral|Exercise|multidirectional unilateral hopping exercise
16120533|NCT02007447|Drug|OCYTOCINA - SPRAY NASAL|The initial sample is divided into two groups (A and B): group A receive oxytocin intranasal for 8 weeks 24UI twice a day (3 applications per nostril 4UI 12/12 hours); group B will receive placebo for 8 weeks
16120534|NCT02007434|Drug|Deoxycholic Acid Injection|Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
16120535|NCT02007434|Drug|Placebo|Phosphate buffered saline placebo for injection
16120536|NCT02007434|Other|Cold Compress|A cold compress was applied to the injection area for 10 minutes before dosing and for 15 minutes after dosing.
16120537|NCT02007434|Drug|Lidocaine / Epinephrine|Lidocaine 4% topical cream applied 45 minutes prior to dosing across the area to be treated, followed by 0.4 mL SC injections of lidocaine HCl 1% / epinephrine 1:100,000 around the perimeter of the treatment area and across the treatment area in a regular pattern 25 minutes before dosing.
16120538|NCT02007434|Drug|Loratadine|Loratadine 10 mg orally from Day -7 until Day 7
16120539|NCT02007434|Drug|Ibuprofen|Ibuprofen 600 mg at least 1 hour prior to dosing and 600 mg 3 times a day for at least 3 days after dosing.
16120540|NCT02007434|Other|Compression Chin Strap|A compression chin strap was applied 15 minutes after dosing for at least 24 hours.
16120541|NCT02007421|Procedure|Participants asked questions about recent experiences of anal intercourse in the last six months.|"Therefore, it is proposed we conduct a longitudinal study of the epidemiology of low risk and high risk HPV infection and related low grade and high grade anal cancers in HIV negative and HIV positive homosexual men who are 35 years or older. Participants are asked questions about recent experiences of anal intercourse in the last six months.
~At baseline, all men (both HIV positive and HIV negative)will undergo a behavioural questionnaire, and anal swabs which will be tested for HPV and cytology. An HRA will also be performed on all men. Blood will be collected for HIV testing for HIV negative participants, syphilis and storage. Participants will be followed up for three years with one six-monthly visit in the first year then annually. A 6th study visit to discuss all study results will take place 2-3 months after the 5th study visit. A behavioural questionnaire, an anal swab, and HRA will be administered at all follow up interviews."
16120542|NCT02007421|Procedure|High Resolution Anoscopy|The HRA is performed on HIV positive and HIV negative participants by study doctor after an examination of the perianal region and perineum. The plastic anoscope is inserted into the anal canal and visualised under high resolution magnification. Biopsy samples will be taken by the clinician for histological assessment if there are any detected abnormalities.
16120543|NCT02007408|Drug|Paracervical block|
16120544|NCT02007408|Drug|Lidocaine spray|
16120545|NCT02007408|Drug|Paracervical block + lidocaine spray|
16120546|NCT02007369|Behavioral|WhatsApp|Intervention arm with relapse prevention intervention in the social group via the social networking service WhatsApp and the duration of the intervention will be 8 weeks.
16120547|NCT02007369|Behavioral|Facebook|Another intervention arm with the same intervention content, but the platform for the participants to share and receive quitting advice is Facebook and the duration of the intervention will be 8 weeks.
16120548|NCT02007356|Biological|IFN-γ positive selected T-cells|
16120549|NCT02007330|Drug|Systemic intravenous lidocaine infusion|In group L, intravenous lidocaine infusion (0.1mg/kg) for 1minutes after induction of anesthesia. After 1 minutes, lidocaine infusion continued at rate of 1.5mg/kg/hr during operation, and discontinued before move the patients to PACU.
16120550|NCT02007330|Drug|Normal saline infusion|In group C, the patients receive same volume of normal saline
16120551|NCT02007317|Drug|Oshadi D & Oshadi R|Anti tumor agents
16120552|NCT02007304|Behavioral|Eccentric exercise training|12 weeks of lower leg eccentric training
16120553|NCT02007278|Drug|vildagliptin and metformin (combination)|vildagliptin and metformin combination therapy as 50mg/850mg bid or 50mg/1000mg bid
16120554|NCT02007278|Drug|glimepiride|
16120555|NCT02007278|Drug|Metformin|
16120556|NCT02007252|Drug|ACZ885|ACZ885 150 mg liquid pre-filled syringes were administered s.c..
16120557|NCT02007252|Drug|Placebo|Matching placebo liquid pre-filled syringes were administered s.c..
16120558|NCT02007239|Drug|tocilizumab|single dose of tocilizumab (8mg/kg intravenously) within 24 hours of administration of standard immunochemotherapy.
16120559|NCT02007200|Other|Laboratory Biomarker Analysis|Correlative studies
16120560|NCT02007200|Drug|Soy Isoflavones|Given PO
16120561|NCT02007200|Other|Survey Administration|Ancillary studies
16120562|NCT02007187|Drug|Danhong injection|A kind of injection made from two kind of Chinese herbs: salvia miltiorrhiza and safflower
16120563|NCT02007187|Other|Standard medical care|Standard medical care is in accordance with China Guideline for the diagnosis and treatment of unstable angina (UA) and non-ST-elevation myocardial infarction (NSTEMI) (2007) issued by Chinese Society of Cardiology of Chinese Medical Association
16120564|NCT02007187|Drug|Placebo|0.9% saline added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion.
16120565|NCT02007174|Drug|Bevacizumab|
16120566|NCT02007174|Drug|Medical Treatment|Care treatment included topical eyedrops of 0.3% tobramycin and 0.1% dexamethasone (Trazidex, Laboratorios Sophia) three times daily, and 0.5 carboxymethylcellulose lubricating eye drops (Refresh-Tears, Allergan, Irving, California, USA). Topical antibiotics and corticosteroids were tapered and discontinued after two weeks.
16120567|NCT02007174|Drug|Medical Treatment|Care treatment included topical eyedrops of 0.3% tobramycin and 0.1% dexamethasone (Trazidex, Laboratorios Sophia) three times daily, and 0.5 carboxymethylcellulose lubricating eye drops (Refresh-Tears, Allergan, Irving, California, USA). Topical antibiotics and corticosteroids were tapered and discontinued after two weeks.
16120568|NCT02007174|Procedure|Argon laser treatment|
16120569|NCT02007161|Drug|Diclofenac potassium 50 mg|Diclofenac potassium 50 mg
16120570|NCT02007148|Drug|capecitabine|twice a day
16120571|NCT02007148|Drug|Docetaxel|cycles repeated every 3 weeks
16120572|NCT02007122|Other|Ceftaroline in CRRT|Plasma levels of ceftaroline will be measured in patients receiving CRRT
16120573|NCT02007122|Other|Ceftaroline in IRRT|Ceftaroline plasma levels will be measured in patients receiving intermittent renal replacement therapy
16120574|NCT02007096|Drug|Transabdominal Plane Block|0.25% bupivacaine injection in 6 different locations in abdomen. Weight <100kg: 50ml total; weight >100kg: 60ml total
16120575|NCT02007096|Drug|Non Transabdominal Plane Block|Saline injection in 6 different locations in abdomen. Weight <100kg: 50ml; weight >100kg: 60ml
16120576|NCT02007083|Procedure|Bilateral laminotomy (BL)|
16120577|NCT02007083|Procedure|Unilateral laminotomy with crossover (UL)|
16120578|NCT02007083|Procedure|Spinous Process Osteotomy (SPO)|
16120579|NCT02007070|Biological|Pembrolizumab|Intravenous infusion
16120580|NCT02007057|Procedure|Suprascapular nerve block|
16120581|NCT02007057|Procedure|Interscalene nerve block|
16120582|NCT02007044|Drug|Ibrutinib|Given PO
16120583|NCT02007044|Other|Laboratory Biomarker Analysis|Correlative studies
16120584|NCT02007044|Other|Quality-of-Life Assessment|Ancillary studies
16120585|NCT02007044|Other|Questionnaire Administration|Ancillary studies
16120586|NCT02007044|Biological|Rituximab|Given IV
16120587|NCT02007018|Device|Negative Pressure Wound Therapy|Prevena™ Incision Management System (PIMS) (Kinetic Concepts Inc. (KCI), San Antonio, TX) is an incisional vacuum assisted closure (PIMS) device intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy The PIMS applies continuous pressure to the closed surgical site at 125 mm Hg and is attached to a 45 mL canister for collection of exudate.
16120588|NCT02007018|Other|Usual Care of Surgical Wound|Patients will receive pre-operative antibiotics consisting of 1g cefazolin (or in the case of an allergy, an alternative e.g. ciprofloxacin/vancomycin) and 500 mg metronidazole given intravenously within the 30 minute prior to beginning the operative procedure. In cases extending > 4 hours, a second dose of each of the antibiotics will be administered. Hair at the operative site will be removed, if required, immediately prior to the skin incision using electric clippers. The abdomen will be prepped using 2% Chlorhexidiene solution (or 10% povidone if allergic). After closure of the skin, the surgical wound will be covered with a sterile adhesive dressing (Tegaderm), which will remain in place until the morning of post-operative day (POD)#2, unless saturated, in which case it is standard practice to change the dressing if the physician is in agreement. On POD#2, the surgical team will remove the initial dressing and daily dressing changes with standard gauze will be initiated.
16120589|NCT02007005|Drug|abnobaVISCUM Fraxini|intravesical instillation 6 times, once weekly, in increasing dosages until dose-limiting-toxicity occurs
16120590|NCT02006992|Other|RTF Infant Formula|a RTF extensively hydrolyzed infant formula
16120591|NCT02006992|Other|Powder Infant Formula|a powdered extensively hydrolyzed infant formula.
16120592|NCT02006979|Other|exercise|An acute bout of exercise performed 24 hours prior to every anthracycline infusion.
16120593|NCT02006966|Drug|Systemic intravenous lidocaine infusion|In group L, intravenous lidocaine infusion(0.1mg/kg) for 10minutes after induction of anesthesia. After 10 minutes, lidocaine infusion continued at rate of 3mg/kg/hr during operation, and discontinued before move the patients to PACU.
16120594|NCT02006966|Drug|Normal saline infusion|In group C, the patients receive same volume of normal saline
16120595|NCT02006953|Procedure|Bolus feeding schedule following gastrostomy tube placement|
16120596|NCT02006953|Procedure|Continuous chimney feeds following gastrostomy tube placement|
16120597|NCT02006940|Device|miniprobe Alveoflex|Alveoflex uses 488nm laser, generating real time moving images with an optical area of 600μm at a video frame rate of 12 images per second and a focus depth of 50μm
16120598|NCT02006927|Device|Nerve Stimulation|Placement and stimulation of implantable neurostimulation device/leads post radical robotic prostatectomy
16120599|NCT02006914|Dietary Supplement|Chromium Picolinate|Subjects will be asked to take chromium picolinate; 2 tablets per day, 1000 mcg or a placebo for a total of 8 weeks.
16120600|NCT02006901|Procedure|microdecompression|a minimal invasive surgical technique
16120601|NCT02006901|Procedure|laminectomy|The traditional open surgical technique: decompression with removal of the spinous process, lamina and often the medial facets
16120602|NCT02006888|Drug|IBI-10090|
16120603|NCT02006888|Drug|Placebo|Placebo
16120604|NCT02006875|Device|rTMS|Interventions started on the next weekday after pretest and were performed once a day for 15 consecutive weekdays. Participants in the E and C groups received rTMS (either real or sham, 1 Hz, 15 minutes), followed by a session of physical therapy for 45 minutes.
16120605|NCT02006849|Drug|Acthar|FDA approved drug being used in this study for sub-nephrotic proteinuria. Given Investigational New Drug (IND) exemption by FDA.
16120606|NCT02006836|Dietary Supplement|Pomelo|The sugar content of the pomelo was 5.86% of full weight, and we use 922g Majia pomelos which contained about 50g sugar equal to 50g glucose for GI measurement.
16120607|NCT02006836|Dietary Supplement|Glucose|We dissolved 50 g of glucose in 200 ml water.
16120608|NCT02006836|Other|Blank|For the self-control period the diabetic patients underwent 3-day CSII treatment without change of insulin dose and we did not applied any intervention.
16120609|NCT02006836|Drug|Insulin|Patients who were included in the test of glycemic responses to postprandial pomelo consumption were hospitalized with the treatment of Continuous Subcutaneous Insulin Infusion(CSII), and the insulin for CSII was insulin aspart(NovoRapid).
16120610|NCT02006836|Drug|met or diet|In diabetic group, 20 diabetic patients were included for GI measurement , 18 of whom were on metformin treatment. Only 2 patients were on diet control due to the early stage of this disease.
16120611|NCT02006810|Behavioral|Induction of endothelial function variations|
16120612|NCT02006797|Other|reconciliation|medication reconciliation at discharge and communication of this intervention to patient's community pharmacist
16120613|NCT02006771|Other|Southern Chinese meal|White rice (1 bowl), stir fried choi sum (0.5 bowl) and stir fried lean pork (0.5 bowl) cooked with maize oil
16120614|NCT02006771|Other|Northern Chinese meal|Noodles (1 bowl) and shredded pork with sweet bean sauce (0.5 bowl) cooked with blend oil
16120615|NCT02006771|Other|American meal|Hamburger with cheese (1 piece), French fries (117 g) cooked with canola blend oil and Coca-cola classic (21 fluid ounces)
16120667|NCT02006394|Other|Reduced glycemic index bread products|Made by Zone Labs
16120616|NCT02006771|Other|South Indian meal|Basmati rice (1 bowl), chicken curry dish (0.5 bowl), dry vegetable dish (i.e. green beans mixed with herbs) (0.5 bowl), yogurt made with milk powder mainly (0.5 bowl), pickle made with lemon, salt, chilli powder, Asafoetida and vegetable based oil (1 tablespoon)
16120617|NCT02006758|Device|EnligHTN™ Renal Denervation System|The EnligHTN™ Renal Denervation System is designed to deliver radiofrequency (RF) energy to the renal nerves to achieve targeted denervation. The system consists of the EnligHTN™ RF Ablation Generator (generator), the EnligHTN™ Renal Artery Ablation Catheter (ablation catheter), and the EnligHTN™ Guiding Catheter (optional).
16120618|NCT02006745|Drug|Ribavirin|24 weeks in those achieving RVR (undetectable HCV RNA at 4 weeks) or 48 weeks in those not achieving RVR
16120619|NCT02006745|Drug|Telaprevir|12 weeks in those achieving RVR, 24 weeks in those not achieving RVR (HCV RNA >25 but <1000 iU/mL at week 4) or 48 weeks in those not achieving RVR (HCV RNA >1000 iU/mL at week 4).
16120620|NCT02006732|Drug|olodaterol|fixed dose combination
16120621|NCT02006732|Drug|tiotropium|fixed dose combination
16120622|NCT02006732|Drug|placebo|
16120623|NCT02006719|Biological|Collagenase Clostridium Histolyticum|Treatment of Adhesive Capsulitis
16120624|NCT02006719|Other|Placebo|Placebo injection
16120625|NCT02006706|Drug|rituximab [MabThera/Rituxan]|1000 mg iv Days 1 and 15
16120626|NCT02006706|Drug|methotrexate|10 - 25 mg/week
16120627|NCT02006706|Drug|methylprednisolone|iv administration on Day 1 and 15 prior to MabThera/Rituxan infusion
16120628|NCT02006693|Device|XEN® Gel Stent|The XEN® Gel Stent (XEN45 implant) was placed in the study eye.
16120629|NCT02006693|Procedure|Cataract Surgery|Participants diagnosed with a cataract elected to have cataract surgery.
16120630|NCT02006667|Drug|trastuzumab|4 mg/kg i.v., Day 3 of Cycle 1, followed by weekly doses of 2 mg/kg i.v., Day 1 of Cycle 2 until disease progression
16120631|NCT02006667|Drug|gemcitabine|1200 mg/m2 i.v. on Days 1, 8, and 15 of Cycle 1 through 6
16120632|NCT02006667|Drug|cisplatin|70 mg/m2 i.v. on Day 2 of Cycles 1 through 6
16120633|NCT02006654|Drug|Placebo|Once daily, matching placebo capsules, orally
16120634|NCT02006654|Drug|Idalopirdine|Once daily, encapsulated tablets, orally
16120635|NCT02006641|Drug|Placebo|Once daily, matching placebo capsules, orally
16120636|NCT02006641|Drug|Idalopirdine|Once daily, encapsulated tablets, orally
16120637|NCT02006628|Drug|Placebo|Placebo oral solution (0 milligrams [mg]/mL CBD) contained the excipients sesame oil, ethanol, sucralose, and strawberry flavoring.
16120638|NCT02006628|Drug|GWP42003|GWP42003 was an oral solution containing 100 mg/mL CBD dissolved in the excipients sesame oil, ethanol, sucralose and strawberry flavoring.
16120639|NCT02006615|Device|Functional near infrared spectroscopy|Using high-sensitivity infrared to detect the active brain areas
16120640|NCT02006615|Device|rTMS|To modulate brain cortex
16120641|NCT02006602|Drug|Candesartan cilexetil (GW615775, Test formulation)|Test formulation candesartan cilexetil 16 mg will be supplied as round, biconvex white tablets with PX 16 embossed in one face and scored in the other face.
16120642|NCT02006602|Drug|Candesartan cilexetil (Reference treatment)|Reference treatment of candesartan cilexetil 16 mg will be supplied as round, biconvex pink tablets, scored in one face and with embossment in both faces (016 embossment in the plain face and A CH in the scored face).
16120643|NCT02006589|Drug|Candesartan cilexetil (GW615775, Test formulation)|Test formulation candesartan cilexetil 8 mg will be supplied as round, biconvex pink tablets with PX 8 embossed in one face.
16120644|NCT02006589|Drug|Candesartan cilexetil (Reference treatment)|Reference treatment of candesartan cilexetil 8 mg will be supplied as round, biconvex pink tablets, scored in one face and with embossment in both faces (008 embossment in the plain face and A CG in the scored face).
16120645|NCT02006576|Drug|600 mg ibuprofen three times daily for 48 weeks|
16120646|NCT02006576|Other|Placebo three times daily|
16120647|NCT02006537|Drug|GSK2256294|GSK2256294 is a 5 mg capsule administered orally as a 10 mg dose in the fasted or fed state
16120648|NCT02006524|Device|'MyDiagnostick|
16120649|NCT02006511|Device|Incisional Neg Pressure Wound Therapy (Prevena™)|Negative pressure wound therapy dressing applied over closed surgical incision
16120650|NCT02006511|Other|Standard of Care wound therapy|Gauze type dressing.
16120651|NCT02006498|Drug|Sillymarin|Sillymarin is derived from the milk thistle plant, Silybum marianum, a herbal remedy that has been used for centuries for diseases of the liver. It is a complex mixture of 6 major flavonolignans (silybins A and B, isosilybins A and B, silychristin, and silydianin), as well as other minor polyphenolic compounds.
16120652|NCT02006498|Drug|Placebo|Placebo capsule with same appearances as study drug
16120653|NCT02006485|Drug|Ublituximab + TGR-1202|Ublituximab IV infusion TGR-1202 oral daily dose
16120654|NCT02006485|Drug|Ublituximab + TGR-1202 + ibrutinib|Ublituximab IV infusion TGR-1202 oral daily dose Ibrutinib oral daily dose
16120655|NCT02006485|Drug|Ublituximab + TGR-1202 + bendamustine|Ublituximab IV infusion TGR-1202 oral daily dose Bendamustine IV infusion
16120656|NCT02006472|Drug|Pridopidine|22.5 mg and 45 mg capsules
16120657|NCT02006472|Other|Placebo|Capsules matching drug
16120658|NCT02006433|Device|Deep Brain Stimulation|Local anesthesis, MRI and CT scan of the brain followed by implantation of the stimulation device
16120659|NCT02006420|Device|ARFI-SVI Ultrasound|Ultrasound imaging of arm and leg lasting approximately 5-10 minutes. Participants will also undergo durometer scoring on the forearm and thigh as part of the study. This lasts approximately 5-10 minutes.
16120660|NCT02006407|Radiation|Cranial Radiotherapy|Standard cranial radiotherapy administered dependent upon patient and brain tumor type.
16120661|NCT02006407|Device|MRI with Diffusion Tensor Imaging (DTI)|Magnetic Resonance Imaging (MRI) with Diffusion Tensor Imaging (DTI)
16120662|NCT02006407|Behavioral|Neuro-cognitive Testing (CogState)|CogState is a computerized software testing system that offers various cognitive assessments based traditional expansive neurocognitive tests.
16120663|NCT02006394|Dietary Supplement|Fish Oil|fish oil capsules
16120664|NCT02006394|Dietary Supplement|Polyphenol Capsules|delphinidin polyphenol capsules
16120665|NCT02006394|Dietary Supplement|Corn Oil Capsules|Corn Oil Capsules
16120666|NCT02006394|Dietary Supplement|Corn starch capsules|Maltodextrin capsules
16120668|NCT02006394|Other|Market variety bread products|placebo bread products
16120669|NCT02006368|Other|Blood Collection and autologous re-infusion|"Subjects will donate one unit of whole blood. This unit will be stored at 4°C for a predefined storage period. A variety of in vitro metabolic and functional platelet assays will be performed on the stored unit.
~After the storage period, an aliquot from the whole blood unit will be processed to obtain platelets. The subject will return and donate a fresh sample of whole blood (43 mls) from which a fresh aliquot of platelets will be obtained. The stored and fresh platelets will each be labeled with a different radioisotope (either Chromium-51 or Indium-111) and reinfused into the subject. Using two different radioisotopes enables separate tracking of both the stored and fresh platelets. Follow-up blood samples will be drawn at 2 hours and on days 1, 2, 3, 5, 7±1 and 10±2. Stored and Fresh platelet recoveries and survivals will be calculated."
16120670|NCT02006355|Drug|Ropivacaine|
16120671|NCT02006342|Drug|Insulin Glargine|
16120672|NCT02006342|Drug|Regular Insulin|
16120673|NCT02006329|Device|acupuncture|
16120674|NCT02006316|Procedure|Microsurgical subinguinal varicocelectomy|
16120675|NCT02006303|Procedure|Green light PVP|The green light laser has a wavelength of 532 nm which is strongly absorbed by red tissues and hemoglobin; this renders a blood rich organ such as the prostate gland to be an excellent target. The procedure uses the technology of high-powered laser light combined with fiber optics to vaporize the overgrowth of prostate cells quickly and accurately. As the surgeon directs the laser at the prostate, the intense pulses of light emitted from the fiber are absorbed by the blood. Within moments, the temperature of the blood becomes so great it causes the nearby cells to vaporize. Once the procedure is completed, patients have immediate post-operative symptom relief and dramatic improvements in symptoms, urinary flow rates, and bladder emptying.
16120676|NCT02006303|Procedure|Prostatic artery embolization|Prostatic artery embolization consists of gaining access into the patients arterial system via a common femoral artery puncture using a small needle and sheath. Once the access is established, a micro-catheter is navigated through the arterial system using X-ray guidance into the arteries feeding the prostate. There, small polyvynil alcohol plastic beads are injected to block the blood flow to the prostate. By doing so, the prostate undergoes an ischemic injury and there is reduction in gland size and relief of obstructive symtpoms.
16120677|NCT02006290|Drug|PF-06412562|single oral split dose 30+20 mg QD
16120678|NCT02006290|Drug|Placebo|tablet, matching placebo, QD
16120679|NCT02006277|Drug|Crizotinib prototype microsphere 0.529 mg/mg|Subjects will take each sample into their mouths, swirl the sample for approximately 30 seconds, and then expectorate into an empty cup.
16120680|NCT02006277|Drug|crizotinib prototype microsphere 0.470 mg/mg|Subjects will take each sample into their mouths, swirl the sample for approximately 30 seconds, and then expectorate into an empty cup.
16120681|NCT02006277|Drug|crizotinib prototype microsphere 0.420 mg/mg|Subjects will take each sample into their mouths, swirl the sample for approximately 30 seconds, and then expectorate into an empty cup.
16120682|NCT02006277|Drug|crizotinib oral solution|Subjects will take each sample into their mouths, swirl the sample for approximately 30 seconds, and then expectorate into an empty cup.
16120683|NCT02006277|Drug|crizotinib prototype microsphere 0.529 mg/mg|Subjects will receive a single 250-mg oral dose of crizotinib.
16120684|NCT02006277|Drug|crizotinib prototype microsphere 0.470 mg/mg|Subjects will receive a single 250-mg oral dose of crizotinib.
16120685|NCT02006277|Drug|crizotinib prototype microsphere 0.420 mg/mg|Subjects will receive a single 250-mg oral dose of crizotinib.
16120686|NCT02006277|Drug|crizotinib capsule|Subjects will receive a single 250-mg oral dose of crizotinib.
16120687|NCT02006277|Drug|crizotinib oral solution|Subjects will receive a single 250-mg oral dose of crizotinib.
16120688|NCT02006264|Drug|TDF Intravaginal Ring|The TDF IVR intravaginal ring is formulated using flexible outer tubing, comprised of hydrophilic, aliphatic polyether urethane, and an inner core compartment comprised of 86% w/w TDF and 14% w/w sodium chloride (NaCl). The TDF intravaginal ring will be worn continuously for 14 days. It will be inserted into the vagina following cessation of participant's menses at Visit 3 and removed at Visit 7.
16120689|NCT02006264|Drug|Placebo Intravaginal Ring|The placebo ring is formulated using flexible outer tubing, comprised of hydrophilic, aliphatic polyether urethane, and an inner core comprised of sodium chloride (NaCl). The Placebo intravaginal ring will be worn continuously for 14 days. It will be inserted into the vagina following cessation of participant's menses at Visit 3 and removed at Visit 7.
16120690|NCT02006238|Device|Farabloc|The participants will be randomly received Farabloc (experimental) for one week, followed by a 7 day washout and then crossed over to received the Nylon fabric (placebo) for one week.
16120691|NCT02006238|Device|Nylon Fabric|The participants will be randomly received Nylon fabric (placebo) for one week, followed by a 7 day washout and then crossed over to receive Farabloc (experimental) for one week.
16120692|NCT02006225|Drug|Plerixafor|
16120693|NCT02006212|Procedure|If any intraoperative EEG abnormality and/or asymmetry is detected a cerebral CT scan will be performed in the immediate postoperative period|
16120694|NCT02006199|Behavioral|mindfulness meditation|8 weeks of mindfulness meditation specified for OCD patient
16120695|NCT02006186|Behavioral|Bicycle Train|The Bicycle Train intervention consists of research staff members who bike to and from school with enrolled participants
16120696|NCT02006173|Drug|Lidocaine|Xylocaine is a 2 % lidocaine hydrochloride contained liquid anesthesia
16120697|NCT02006173|Drug|Normal Saline|
16120698|NCT02006160|Drug|dalfampridine|10 mg bid
16120699|NCT02006160|Drug|placebo|10 mg bid
16120700|NCT02006147|Drug|TLC399|Dose-escalation Study from 100 mM PL (20 µL) with 0.24 mg DSP to 100 mM PL (20 µL) with0.36 mg DSP to 100 mM PL (20 µL) with 0.6 mg DSP to 50 mM PL (10 µL) with 0.6 mg DSP.
16120701|NCT02006121|Drug|Apomorphine hydrochloride|Apomorphine hydrochloride 5 mg/ml solution for infusion in pre-filled syringe
16120702|NCT02006121|Drug|Placebo|Sodium chloride 9 mg/ml
16120703|NCT02006108|Drug|Feraheme|Therapeutic classification: iron preparations. Use: Off-label use of ultrasmall paramagnetic iron nanoparticle as contrast agent for magnetic resonance imaging
16120704|NCT02006108|Other|MRI-GE Healthcare 3 Tesla magnet|All patients will undergo
16120705|NCT02006095|Other|Magnetic resonance imaging|arterial spin labeling, diffusion tensor imaging, and diffusion weighted imaging sequences will be used
16120707|NCT02006082|Device|Telemedicine video-consultation (TVC)|All patients enrolled in the study, were previously monitored by TVC, and the number and length of hospital stays within 6 and 12 months following TVC were compared to similar numbers before TVC in comparable time periods. Thus, TVC is actually not to be considered as an intervention.
16120708|NCT02006069|Device|MPP|"All patients enrolled in the study will be implanted (according to current Guidelines) with an MPP compatible CRT device.
~The MPP feature will be evaluated in two study phases. Patients randomized to MPP in Phase I will have MPP programmed per the physician's discretion (no mandated MPP programming) and patients randomized to MPP in Phase II will have MPP programmed per protocol requirements (mandated MPP programming)."
16120709|NCT02006056|Drug|Ondansetron|Patients will take Ondissolve (8mg) on the day of the radiation treatment at least one hour prior to treatment and repeat approximately 6-8 hours later in the day (bid). For patients who are being treated with 20Gy in 5 fractions, or 30 Gy in 10 fractions, this group will take Ondissolve twice (bid) on each day of treatment, at least 1 hour prior to treatment and also on weekends or holidays in between treatment.
16120710|NCT02006043|Drug|Erlotinib 150mg|
16120711|NCT02006030|Drug|ADI-PEG 20|
16120712|NCT02006030|Drug|Transarterial chemoembolization|
16120713|NCT02006017|Other|Evidence summary alone plus a recommendation|
16120714|NCT02006017|Other|Evidence summary alone|
16120715|NCT02005991|Drug|PF-05212377|Single, oral dose administration of 70 mg PF-0521377 using a capsule formulation.
16120716|NCT02005991|Drug|PF-05212377|Single, oral dose administration of 20 mg PF-0521377 using a capsule formulation. This dose is an estimate. The exact dose for Arm 2 will be based on the results from Arm 1.
16120717|NCT02005991|Drug|PF-05212377|Single, oral dose administration of 10 mg PF-0521377 using a capsule formulation. This dose is an estimate. The exact dose for Arm 2 will be based on the results from Arms 1 and 2.
16120718|NCT02005939|Dietary Supplement|Pomegranate extract|All randomised participants to the intervention arm receive one pomegranate capsule daily for 4 weeks
16120719|NCT02005926|Procedure|Wire-localized abnormal node|Before the sentinel lymph node biopsy (SLNB) operation, a hookwire was placed at the suspicious axillary lymph node by ultrasound guidance to localize the abnormal node. In the SLNB operation, radioactive nodes and wire-localized nodes were removed and labeled separately for pathological examination.
16120720|NCT02005900|Drug|Docosahexaenoic acid (DHA) administration to modulate Triglycerides in HIV patients under HAART|Multicenter, prospective, double-blind, randomized study of 48 weeks duration, in which the effect of 4 g daily of DHA vs 4 g daily of placebo (oleic acid) are studied on modulation of the Triglycerides and other lipids in patients with HIV infection under HAART treatment.
16120721|NCT02005887|Drug|triptorelin|Triptorelin 3.75 mg injected into the muscle on day 1 every 28 days for 6 cycles (1 cycle= 28 days)
16120722|NCT02005887|Drug|degarelix|Degarelix 240 mg injected under the skin given as two injections of 120 mg on the first day of treatment, followed by injection of 80 mg on day 1 of cycles 2 to 6 (1 cycle=28 days)
16120723|NCT02005887|Drug|letrozole|Letrozole 2.5 mg orally every day for 6 cycles
16120724|NCT02005861|Procedure|bone marrow cells transplantation on collagen scaffold|"120 ml of venous blood will be collected for the platelet gel production. The day of the surgery, 60 ml of bone marrow will be aspirate from the posterior iliac crest and concentrated. a standard ankle arthroscopy will be performed, with the patient in the supine position. The lesion will be detected and cleaned.
~An equine collagen type 1 scaffold (IOR-G1, Novagenit, Mezzolombardo, TN, Italy) will be loaded with 2 ml of bone marrow concentrate and cut into an appropriate shape to fit the lesion.
~After the scaffold implantation 2 ml of platelet gel will be loaded on the top of implant, in order to provide growth factors and to improve the stability of the implant."
16120725|NCT02005848|Biological|Alpha-1 Antitrypsin|
16120726|NCT02005848|Other|Placebo|Placebo
16120727|NCT02005835|Other|Community based peer support|"Community-based Support from Peer Mothers (Expert mothers):
~Routine standard clinical care based on the MoH guidelines Mentor mothers provide education and psychosocial support in community prior to each visit Monthly support groups in community Home visits for each missed appointment"
16120728|NCT02005835|Other|Facility-based Peer Support|"Facility-based Peer Support to provide the following at the clinic
~Routine standard clinical care based on the MoH guidelines Mentor mothers provide education and psychosocial support at facility Weekly support groups provided in clinic Phone call, SMS, or home visit for each missed appointment"
16120729|NCT02005822|Drug|Valganciclovir|Infants will be treated with valganciclovir for 6 weeks, 32 mg/kg daily dose in two doses, oral solution.
16120730|NCT02005809|Procedure|second look endoscopy|Second look endoscopy includes observation or prophylactic bleeding control of ESD site.
16120731|NCT02005796|Other|Dietary intervention|
16120732|NCT02005783|Drug|DBD|DBD:one dose of medicine twice per day, orally
16120733|NCT02005783|Drug|Epirubicin|Epirubicin:90mg/m2, d1, q3w*4
16120734|NCT02005783|Drug|Cyclophosphamide|Cyclophosphamide:600mg/m2, d1, q3w*4
16120735|NCT02005783|Drug|Docetaxel|Docetaxel:75mg/m2, d1, q3w*4
16120736|NCT02005770|Drug|Sevoflurane|
16120737|NCT02005770|Drug|Propofol|
16120738|NCT02005757|Drug|Bredinin tablet 150mg|Bredinin 150mg qd vs Bredinin 50mg tid
16120739|NCT02005757|Drug|Bredinin tablet 50mg|Bredinin 150mg qd vs Bredinin 50mg tid
16120740|NCT02005744|Drug|CKD-501|CKD-501 0.5mg, PO(per oral), once
16120741|NCT02005731|Device|Low intensity linear focused shockwave device ('Renova')|
16120742|NCT02005718|Drug|Cholecalciferol|
16120743|NCT02005705|Other|Outpatient Management of Low-risk Patients|"Labs will be obtained within 2-3 days of discharge from ED
~Clinic visit will be scheduled within 3 days of discharge from ED
~EGD will be scheduled within 7 days of discharge from ED
~Phone follow-up at day 7 and 30"
16120744|NCT02005705|Other|Inpatient Management of Low-risk Patients|"Labs will be obtained on day of discharge or day 2-3
~EGD will be performed in the hospital
~Phone follow-up at day 7 and 30"
16120745|NCT02005692|Device|DynaSense sensor|
16120746|NCT02005679|Behavioral|application of the mini-mental state test|
16120747|NCT02005666|Drug|Clindamycin Phosphate 1.2% / Benzoyl Peroxide 5% Gel|Drug:-1.2% Clindamycin Phosphate/ 5% Benzoyl Peroxide Gel of Cadila healthcare limited Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
16122335|NCT01993199|Procedure|deep biopsy via ESD technique|
16120748|NCT02005666|Drug|DUAC® Gel|Drug:-DUAC® Gel Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
16120749|NCT02005666|Drug|Placebo|Drug:-Placebo, Dosage Form:-Gel Dosage:-Thin Layer/Pea sized Frequency:-Once a day ,every evening Duration:-77 consecutive days
16120750|NCT02005653|Drug|Diethylcarbamazine|Diethylcarbamazine 300 mg tablet as single dose per day for 12 days
16120751|NCT02005653|Drug|Albendazole|Experimental
16120752|NCT02005653|Drug|Doxycycline|Experimental
16120753|NCT02005627|Drug|Grazax|The active treatment arm will receive active grass pollen immunotherapy tablet (AIT), Grazax Oral Lyophilisate 75,000 SQ-T once daily.
16120754|NCT02005627|Drug|Grazax Placebo|This arm will receive Grazax placebo once daily which contains the same composition as in the active Grazax tablet with the only difference being the exclusion of the grass pollen allergen extract.
16120755|NCT02005614|Procedure|Gamma Knife Radiosurgery|"Treatment will be administered on an outpatient basis. No other treatment, investigational or commercial agents or therapies other than those described below may be administered with the intent to treat the patient's brain metastases.
~Gamma knife radiosurgery is a one day out-patient procedure. Time from initiation of treatment (premedication and placement of a stereotactic frame) until end of treatment (completion of radiation delivery and removal of stereotactic frame) ranges from 3 to 16 hours."
16120756|NCT02005601|Drug|Placebo|Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.
16120757|NCT02005601|Drug|Duloxetine 60mg|Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.
16120758|NCT02005588|Drug|amino acid chelated iron|the drug will be given to pregnant women 14-18 weeks' gestation who prove to have iron deficiency anemia. the dose will be given according to hemoglobin level. for hemoglobin 7-9 g/dl, 2 capsules will be given daily. for hemoglobin 9.1-11 g/dl, 1 capsule will be given daily. complete blood picture and serum ferritin will be measured at 22-23, 29-30 and 36-37 weeks' gestation.
16120759|NCT02005588|Drug|iron salt (ferrous fumarate)|this drug will be given to pregnant women 14-18 weeks' gestation with iron deficiency anemia. the dose will be given according to hemoglobin level. for hemoglobin 7-9 g/dl, 2 capsules will be given daily, and for hemoglobin 9.1-11 g/dl, 1 capsule will be given daily. complete blood picture and serum ferritin will be measured at 22-23, 29-30 and 36-37 weeks' gestation.
16120760|NCT02005575|Drug|Bupivacaine and Dexamethasone|The standard of care is to use a regional block solution containing both decadron and bupivicaine.
16120761|NCT02005575|Drug|Placebo|
16120762|NCT02005562|Drug|mycophenolate mofetil|3 g p.o. in divided doses q12h beginning on the day of renal transplant, Day 0, or the day before, Day -1, and continuing to Week 52, adapted to MPA by AUC on Weeks 2, 6, 12, 26, and 52 to obtain AUC0-12 of 50 milligrams (mg) multiplied by (*) height (h)/ liter(L).
16120763|NCT02005562|Drug|mycophenolate mofetil|2 g p.o. in divided doses q12h beginning on the day of renal transplant, Day 0, or the day before, Day -1, and continuing to Week 52.
16120764|NCT02005562|Drug|anti-IL-2R|Induction by IL-2R was administered at Day 0 per standard of care at the site at the investigators discretion.
16120765|NCT02005562|Drug|methylprednisolone|500 mg intravenous (i.v.) was administered before or after the transplantation, and 0.5 mg/kg p.o. daily from Day 1 to Day 7.
16120766|NCT02005562|Drug|cyclosporine|100-1500 nanograms (ng) per milliliter (mL) from Day 0 to Week 4, 800-1200 ng/mL from Week 4 to Week 12 and 500-800 ng/mL from Week 12 to Week 52
16120767|NCT02005549|Drug|bevacizumab [Avastin]|15 mg/kg iv on Day 1 of each 3-week cycle, 5 cycles
16120768|NCT02005549|Drug|docetaxel|75 mg/m2 on Day 1 of each 3-week cycle, 6 cycles
16120769|NCT02005549|Drug|capecitabine [Xeloda]|950 mg/m2, orally twice daily, evening of Day 1 until morning of Day 15, followed by a 7 day rest period, every 3 weeks
16120770|NCT02005536|Biological|IMOVAX POLIO®: Inactive Poliovirus Vaccine|0.5 mL, Subcutaneous
16120771|NCT02005523|Drug|RNS60|
16120772|NCT02005523|Drug|Saline|
16120773|NCT02005510|Behavioral|Mailed in-home high-risk HPV testing kit|
16120774|NCT02005510|Other|Usual care|
16120775|NCT02005497|Other|HealthLinks|
16120776|NCT02005484|Drug|Trastuzumab|4 mg/kg initial dose, followed by 2 mg/kg
16120777|NCT02005471|Drug|Bendamustine|Bendamustine will be administered at a dose of 70 mg/m^2 via IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
16120778|NCT02005471|Drug|Venetoclax|"Venetoclax will be administered at an initial dose of 20 mg via tablet orally QD, incremented weekly up to a maximum dose of 400 mg during a 5-week ramp-up period. Venetoclax will be continued at 400 mg QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to disease progression (PD) or 2 years, whichever occurs first.
~R/C Substudy: venetoclax will be administered for 5-week dose ramp-up period to reach the target dose of 400 mg QD. Venetoclax will continue to be administered during the rituximab cycles until disease progression or for a maximum of 2 years from Cycle 1R/C Day 1 of the R/C Substudy."
16120779|NCT02005471|Drug|Rituximab|"Rituximab will be administered at a dose of 375 mg/m^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m^2 on Day 1 of Cycles 2-6.
~R/C Substudy: Following the venetoclax ramp-up period, rituximab will be administered for 6 cycles consisting of a single infusion on the first day of each 28-day cycle."
16120780|NCT02005458|Drug|YPEG-rhG-CSF, 20μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle|
16120781|NCT02005458|Drug|YPEG-rhG-CSF, 30μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle|
16120782|NCT02005458|Drug|YPEG-rhG-CSF, 45μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle|
16120783|NCT02005458|Drug|PEG-rhG-CSF, 100μg/kg, single s.c. at 48hrs after chemotherapy for each experimental cycle|
16120784|NCT02005445|Device|CPAP|Continuous positive airway pressure
16120785|NCT02005445|Behavioral|HLSE|Healthy living and sleep education
16120786|NCT02005432|Drug|Intravitreal Ranibizumabe|Intravitreal injection 0,05ml Ranibizumabe
16120787|NCT02005432|Drug|panfotocoagulation (PASCAL)|
16120788|NCT02005432|Drug|panfotocoagulation (PRP) single shoot (ETDRS)|
16120825|NCT02005172|Device|Alivecor monitor and 14 day event monitor|Alivecor monitor and 14 day event monitor
16120826|NCT02005159|Other|Microbiological studies|
16120827|NCT02005120|Drug|Bevacizumab|Intrapleural administration of bevacizumab
16120789|NCT02005419|Drug|Gemcitabine|Patients receive gemcitabine 1000 mg/m^2 (iv, 30 minutes) on days 1, 8, and 15 for 3 weeks, followed by one week without treatment, and also receive placebo (Arm I)/ metformin (Arm II) on days 1-28. Treatment repeats every 4 weeks for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.
16120790|NCT02005419|Drug|Metformin|Metformin will be administered at a dose of 500 mg twice daily. If well tolerated, the dose will be increased to 1000 mg twice daily in the second week. Treatment repeats every 4 weeks (2 g on days 1-28) for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.
16120791|NCT02005419|Drug|placebo|Placebo will be administered at a dose of 500 mg twice daily. If well tolerated, the dose will be increased to 1000 mg twice daily in the second week. Treatment repeats every 4 weeks (2 g on days 1-28) for up to 6 circles in the absence of disease recurrence or unacceptable toxicity.
16120792|NCT02005406|Device|Experimental group and control groupl|JET
16120793|NCT02005393|Device|FICE Image Acquisition followed by NBI Image Acquisition|Images Captured with FICE Device, followed by same locations imaged with NBI Image Acquisition System
16120794|NCT02005380|Other|Text-based task|Participants are required to take text-based exercise.
16120795|NCT02005380|Other|Graphic-based Task|Participants are required to take the graphic-based exercise.
16120796|NCT02005367|Behavioral|Natural Recovery-Horticulture|"Participants in Natural Recovery-Horticulture received a one-hour small group therapy session during the week using Horticulture modules with a staff facilitator while DAP-CP participants attended a large psychoeducational group at that time.
~Natural Recovery participants also pursued four hours of gardening on each weekend day while DAP-CP attended large-group lectures."
16120797|NCT02005367|Behavioral|Natural Recovery-Art/Music|Participants in Natural Recovery-Art/Music received a one-hour small group therapy session during the week using Art/Music modules with a staff facilitator while DAP-CP participants attended a large psychoeducational group at that time. Natural Recovery participants also pursued four hours of art or music on each weekend day while DAP-CP attended large-group lectures.
16120798|NCT02005354|Device|Trans-cutaneous Electrical Nerve Stimulation (TENS)|Patients in whom a bone marrow biopsy is planned will be randomised to one of two groups - a Placebo Comparator group where the TENS machine will be set at the lowest sensory threshold and an Active Comparator group where the TENS machine will be set at a recognised analgesic level (>50Hz and below the pain threshold for the patient).
16120799|NCT02005354|Drug|Standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide)|All patients will receive standard pain relief (ie. local anaesthetic with or without inhaled nitrous oxide)
16120800|NCT02005341|Device|nanOSS|
16120801|NCT02005341|Device|Autograft|
16120802|NCT02005328|Device|Tested product : DC161-DP0291|Application of product in the mouth twice daily
16120803|NCT02005328|Device|Tested product : DC161-DP0292|Application of product in the mouth twice daily
16120804|NCT02005328|Device|Tested product : DC161-DP0293|Application of product in the mouth twice daily
16120805|NCT02005328|Device|Reference product: solution for oromucosal sprays|Application of product in the mouth twice daily
16120806|NCT02005315|Drug|Vantictumab|Administered intravenous (IV) infusion.
16120807|NCT02005315|Drug|Nab-Paclitaxel|Nab-Paclitaxel will be administered by intravenous (IV) infusion.
16120808|NCT02005315|Drug|Gemcitabine|Gemcitabine will be administered by intravenous (IV) infusion.
16120809|NCT02005302|Drug|1,25(OH)2 Vitamin D3|Oral 1,25(OH)2 Vitamin D3 by 0.25 microgram once daily at start and regulate the dose according to the changes of blood levels of 25(OH)Vit D, calcium, phosphorus, and intact parathyroid hormone.
16120810|NCT02005302|Drug|Vitamin D2|Oral Vit D2 1.25mg(50,000 unit) once weekly as a start and maintain 1.25mg(50,000 unit) once monthly according to the blood 25(OH)vitamin D level.
16120811|NCT02005302|Dietary Supplement|low protein diet|Using nutritious software to make meals recipes and give dietary guidance for patients to reach the DPI goal of 0.6g-0.8g/kg/d.
16120812|NCT02005302|Dietary Supplement|normal protein diet|Using nutritious software to make meals recipes and give dietary guidance for patients to reach the DPI goal of more than 0.8g/kg/d.
16120813|NCT02005289|Biological|MOR00208|Given by IV infusion
16120814|NCT02005289|Drug|lenalidomide|Given PO
16120815|NCT02005289|Other|Correlative Studies|Correlative studies associated with this trial will focus on the effects of MOR00208 alone and in combination with lenalidomide on immune effector cell number and function.
16120816|NCT02005276|Behavioral|Basic Lottery|Participants who meet their daily step goals will be eligible for a daily lottery. They will have about a 1 in 4 chance of winning $5. Expected value is about $1.40 per person per day.
16120817|NCT02005276|Behavioral|Combined Lottery|Participants who meet their daily step goals will be eligible for a daily lottery. They will have about a 1 in 4 chance of winning $5 and a 1 in 100 chance of winning $50. Expected value is about $1.40 per person per day.
16120818|NCT02005276|Behavioral|Jackpot Lottery|Participants who meet their daily step goals will be eligible for a daily lottery. They will have about a 1 in 400 chance of winning $500. Expected value is about $1.40 per person per day.
16120819|NCT02005263|Procedure|Salpingography|Infusion of typically 1-2 mL of air bubbles in to the uterine cavity to assess whether they disappear through the ostia in to the Fallopian tubes.
16120820|NCT02005237|Behavioral|Aerobic Exercise|3-months exercise program tailored to the individual level of aerobic fitness. Patients will exercise on a bicycle ergometer (2-3 session per week) according to a predefined training plan with increasing duration and intensity
16120821|NCT02005224|Other|LCHF diet and a bout of exercise|Low-carbohydrate/high-fat diet; effect on insulin sensitivity, lipid profile, weight and body composition. Participants ingested LCHF diet for three weeks before undergoing an oral glucose tolerance test. The same afternoon the participated in an one hour indoor bicycle training at 75% at HFpeak. The following morning they underwent a new oral glucose tolerance test. Body composition and weight were measured before and after the intervention. Oral glucose tolerance test was also performed before the intervention for baseline. Blood samples were collected before and after the intervention for lipid profile analyses.
16120822|NCT02005211|Drug|AZD3293|Oral solution
16120823|NCT02005211|Drug|Placebo|Oral solution
16120824|NCT02005198|Other|No treatment given|Subject will only fill out a questionnaire when entering the non-interventional study
16122336|NCT01993186|Drug|UX007|oral liquid
16120828|NCT02005120|Drug|recombinant human endostatin|Intrapleural administration of recombinant human endostatin
16120829|NCT02005107|Drug|Venlafaxine IR and Venlafaxine XR|
16120830|NCT02005081|Device|Actifuse SHAPE|Actifuse Synthetic Bone Graft substitutes mixed with bone marrow aspirate in cervical spine fusion. Actifuse is a synthetic, porous, silicate-substituted hydroxyapatite and has shown that this maximizes a favorable bony response.
16120831|NCT02005081|Device|Autograft with Demineralized Bone Matrix|autograft mixed with demineralized bone matrix in cervical spine fusion.
16120832|NCT02005068|Drug|Ceftaroline|The duration of treatment will vary based on type of infection (acute osteomyelitis or joint infection) and if MRSA positive or negative.
16120833|NCT02005055|Procedure|Surgical excision with adjuvant high-dose-rate brachytherapy|The keloid was excised extralesionally and subsequently a metal tipped Varisource catheter was positioned between the dermal edges of the wound, 5 mm below the surface of the skin and extending out of the skin beyond the wound. Primary wound closure was performed and patients were transferred to the radiation department, where the catheter was connected to the Iridium-192 remote control afterloader. The planning target volume was defined as a cylinder along the axis of the scar, with a central diameter of 5mm. Patients received 2 fractions of HighDoseRate brachytherapy. Within 4 hours after the resection, the first brachytherapy fraction of 6 Gy at 5mm of the source axis was given. Within 24 hours after the first fraction a second fraction of 6Gy was administered to a total dose of 12Gy in 2 days. After the second fraction the catheter was gently removed.
16120834|NCT02005042|Behavioral|Feedback on smartphone|Receive personalized feedback (EMI) on smartphone regarding physical activity
16120835|NCT02005029|Drug|Erythromycin|
16120836|NCT02005029|Drug|placebo|
16120837|NCT02005016|Behavioral|Naming therapy|Participants will receive behavioral therapy which is designed to stimulate semantic (meaning) representations which are required for successful naming (word production). Therapy will be administered for 4 weeks on an intensive schedule (5 days a week, approximately 4.5 hours per day).
16120838|NCT02005003|Behavioral|Inhibitory task|Participants perform a binary decision on each presented stimuli. Of the two possible outcomes, participants are instructed to make a motor response (go) for one type, and are to withhold a response (no-go) for the other type. Reaction time and accuracy are measured for each event
16120839|NCT02005003|Procedure|Blood samples|Hormone levels will be analyzed from blood samples obtained before and after a caloric preload given at each visit
16120840|NCT02005003|Biological|Feces collection|Feces samples will be collected on the morning of each visit, before and after each 2-week intervention period, as well as after each 2-week washout period following each intervention period.
16120841|NCT02005003|Procedure|Caloric preload|A caloric preload will be given to participants, following which blood will be taken at 65 minutes later (specified in Blood sampling) following the ingestion of the caloric preload.
16120842|NCT02005003|Behavioral|Food selection task|Participants are given the opportunity to write and use a computer program to specify amount and type of food would ideally like to consume
16120843|NCT02005003|Behavioral|Memory task|Participants perform short memory tasks on each visit
16120844|NCT02005003|Behavioral|Food consumption task|Participants are given a selection of food items to consume on each visit
16120845|NCT02004990|Procedure|Single cleansing procedure of 10% Povidone Iodine|Single cleansing procedure of 10% Povidone Iodine prior to an in-office 5% Sodium Fluoride varnish application
16120846|NCT02004977|Behavioral|Improve access to the school breakfast program|Access to the school breakfast program is defined as implementation of a grab-n-go cart outside of the school cafeteria, policy change allowing students to eat in the hallway and marketing of the program. in rural high schools.
16120847|NCT02004951|Device|Misago RX|
16120848|NCT02004951|Device|Zilver PTX|
16120849|NCT02004938|Device|Sonosite Titan Ultrasound Machine|
16120850|NCT02004912|Other|Mentoring intervention|The mentoring intervention involves periodic supportive visits and education to health center staff by nurse mentors.
16120851|NCT02004899|Drug|Fentanyl|After obtaining informed consent, patients are randomized into one of two treatment groups or a control group by a computer generated random number table. After confirmation of epidural placement following test dose administration, a loading dose of 10 ml 0.08% Bupivacaine containing 20 mcg Fentanyl is administered after adding 1.6 ml 0.9% NaCl (Sodium Chloride) in the control group (F20).
16120852|NCT02004886|Drug|MK-0893|10 mg and 100 mg tablets
16120853|NCT02004886|Drug|Metformin|500 mg metformin tablets
16120854|NCT02004886|Drug|Placebo|Placebo tablets matching MK-0893
16120855|NCT02004886|Drug|Placebo|Placebo tablets matching metformin
16120856|NCT02004873|Device|Micra Pacemaker Implant|
16120857|NCT02004860|Drug|Protopic (R)|Protopic® 0.1% ointment - 2 applications per week for 6 months
16120858|NCT02004860|Drug|Mycoster (R)|Mycoster 1% - 2 applications per week for 6 months
16120859|NCT02004847|Device|PSO-CT02|The PSO-CT02 device is a non CE marked investigational medical device that is worn on the affected skin area where it irradiates the Psoriasis plaque for 30 minutes with blue light.
16120860|NCT02004834|Drug|levobupivacaine|Comparing: 0,5% levobupivacaine with 2% lidocaine
16120861|NCT02004821|Dietary Supplement|Renutryl® Booster, an oral nutritional supplement in a 300 ml bottle (600 kcal, 30 g protein, 72 g carbohydrate, 21 g fat). One bottle per day during 14 days.|
16120862|NCT02004795|Radiation|BNCT + IG-IMRT|Single faction of BNCT (20 Gy) plus IG-IMRT (40 Gy/20 fractions)
16120863|NCT02004782|Drug|Prednisolone|Daily prednisolone is taken for 6 weeks, at a dose of 40mg in week 1, 30mg in week 2, 20mg week 3 and 4, 10mg in week 5, and 5mg in week 6. Prednisolone is taken in the morning. Treatment commences the day of the procedure, with the dose taken with a sip of water prior to discharge. The 6-week treatment regimen is given after both the 1st and 2nd stage CBE.
16120864|NCT02004782|Drug|Placebo Oral Tablet|Daily placebo is taken for 6 weeks, at a dose of 40mg in week 1, 30mg in week 2, 20mg week 3 and 4, 10mg in week 5, and 5mg in week 6. Placebo is taken in the morning. Treatment commences the day of the procedure, with the dose taken with a sip of water prior to discharge. The 6-week treatment regimen is given after both the 1st and 2nd stage CBE
16120865|NCT02004769|Drug|Trastuzumab|Trastuzumab (Herceptin) will be administered at a loading dose of 8 mg/kg (on day 1) followed by 6mg/kg i.v. infusion every 3 weeks (q3w), until disease progress or intolerable toxicity.
16120866|NCT02004769|Drug|Docetaxel|Docetaxel 60mg/m2 (on day 1) every 3 weeks for 6 cycles.
16120867|NCT02004769|Drug|Capecitabine|Capecitabine (Xeloda) 2000mg/m2d, d1-14, every 3 weeks until disease progress or intolerable toxicity.
16120868|NCT02004756|Other|Exercise Program|The Fontan cohort will subsequently complete a 12-week moderate intensity exercise intervention whereby individualized activity-based home interventions will be prescribed (i.e., sample activities: walking, jogging, swimming, cycling, soccer). More specifically, individualized weekly exercise programs for participants will be provided incorporating two specific exercise components.
16120869|NCT02004743|Behavioral|Intervention|"Psychological guidelines and PET
~Patients will receive questionnaires at recruitment, 1 month, 3 months and 6 months based on the timeline of Diagnostic and Statistical Manual (DSM) -IV criteria for PTSD."
16120870|NCT02004743|Other|Treatment as usual|"Participants will experience treatment as usual.
~Patients will receive questionnaires at recruitment, 1 month, 3 months and 6 months based on the timeline of Diagnostic and Statistical Manual (DSM) -IV criteria for PTSD"
16120871|NCT02004730|Device|ABSORB implantation|ABSORB implantation for long (> 24mm) single vessel disease
16120872|NCT02004717|Drug|DS-8895a|
16120873|NCT02004704|Drug|GZ402665|"Pharmaceutical form: Powder for concentrate for solution for infusion
~Route of administration: intravenous infusion"
16120876|NCT02004678|Drug|DS-1150b|
16120877|NCT02004678|Other|Placebo|
16120878|NCT02004652|Drug|Prucalopride|Prucalopride, 2mg, tablet. First given 24 hours after surgery beginning on POD 1,until bowel movements or for a maximum of 7 days of postoperative treatment
16120879|NCT02004652|Drug|Placebo|Vitamin, 50mg, tablet.
16120880|NCT02004639|Radiation|Masticators sparing techniques|
16120881|NCT02004639|Other|electro-acupunture treatment|electro-acupunture treatment and sham-EA
16120882|NCT02004626|Drug|Collagenase|"Conduction of security tests: complete coagulation and glycosylated hemoglobin. Volunteers in childbearing age, with β-HCG (human chorionic gonadotropin) test.
~Verification of anthropometric data, clinical evaluation, PU evaluation, randomization and treatment start.
~Wash the wound with 0.9 % sterile saline solution; Apply of the investigational product directly in the devitalized tissue (necrotic tissue and Slough).
~Cover the wound with sterile gauze and dry transparent film. The procedures for the exchange of bandages must be done every day, twice a day until the total debridement of devitalized tissue.
~Photographic records."
16120883|NCT02004626|Drug|Kollagenase|"Conduction of security tests: complete coagulation and glycosylated hemoglobin. Volunteers in childbearing age, with β-HCG (human chorionic gonadotropin) test.
~Verification of anthropometric data, clinical evaluation, PU evaluation, randomization and treatment start.
~Wash the wound with 0.9 % sterile saline solution; Apply of the investigational product directly in the devitalized tissue (necrotic tissue and Slough).
~Cover the wound with sterile gauze and dry transparent film. The procedures for the exchange of bandages must be done every day, twice a day until the total debridement of devitalized tissue.
~Photographic records."
16120884|NCT02004613|Drug|Dexmedetomidine|Dexmedetomidine
16120885|NCT02004613|Drug|Placebo|Normal saline administration matching dexmedetomidine rate of infusion
16120886|NCT02004600|Procedure|Photodynamic therapy (PDT)|1 session of Photodynamic therapy (PDT) on epidermis dysplasia
16120887|NCT02004587|Drug|Gemigliptin|Gemigliptin is administered to each hepatic impairment subject for single oral dose. Also it is administered to healthy volunteer for single and multiple doses.
16120888|NCT02004574|Drug|Calcipotriol/betamethasone dipropionate gel|"All enrolled subjects will receive Xamiol® gel once daily for 8 weeks during the induction period and then will be assessed according to IGA at the end of 8-week induction period. Those subjects determined to be Responder by IGA will be randomized to one of the following three treatment groups and they will continue their therapy with randomized maintenance regimens for the duration of additional 8 weeks."
16120889|NCT02004548|Drug|Metatinib Tromethamine|
16120890|NCT02004535|Procedure|Cochlear Implantation|The standard surgical procedure for a cochlear implant will be used. The asymmetric participant will receive the cochlear implant in the deaf ear.
16120891|NCT02004522|Drug|Duvelisib|PI3K Inhibitor
16120892|NCT02004522|Drug|Ofatumumab|monoclonal antibody
16120893|NCT02004509|Drug|Anticoagulant|Anticoagulant treatment will be started in case of subclinical atrial fibrillation (>5,5 hours per day) be diagnosed by cardiac implantable electronic device at intervention group, or clinical atrial fibrillation in both groups.
16120894|NCT02004496|Device|Consilium|Patients use a mobile application to track their subjective well-being and adverse events (AE) while ambulant chemotherapy. The mobile app supports the patients in the structured and standardized entry of their data and is developed specifically for this study.
16120895|NCT02004483|Procedure|Percutaneous Coronary Intervention|Percutaneous coronary intervention is performed according to standard practice. Direct stenting is required for the procedure as it is done in most coronary interventions today. After insertion of the non-inflated stent into the coronary lesion there should still be flow to the distal vessel. The stent should be implanted at high-pressure with balloon inflation lasting for 60 seconds to allow adequate expansion of the stent. Post-dilatation should be performed if required. However, this should be done more than 5 minutes after stent implantation.
16120896|NCT02004470|Procedure|Active lavage and suction|Active lavage and suction of the right upper quadrant will be performed as the laparoscopic procedure is about to be terminated.
16120897|NCT02004457|Behavioral|ABBT|
16120898|NCT02004457|Other|TAU|
16120899|NCT02004418|Radiation|11C-Choline|
16120900|NCT02004405|Other|strengthening exercise|"The experimental group (STRE) will receive strengthening training in Station for lifting weight exercises (Flex Mega 8, Flex Fitness Equipment Brand) using the recommendations of the American College of Sports Medicine (ACMS, 2010), twice a week, during 45 minutes for 16 weeks."
16121334|NCT02000830|Drug|Placebo|Matching placebo administered by IM injection
16120901|NCT02004405|Other|flexibility exercise|The control group (FLEX) will receive stretching and flexibility exercise training according to the protocol of prescription and previously tested and described in appendix F (Valim et al., 2003), twice a week, during 45 minutes for 16 weeks.
16120902|NCT02004392|Drug|EVP-6124|
16120903|NCT02004366|Drug|Linagliptin|Linagliptin once daily + correction doses of rapid acting insulin if needed
16120904|NCT02004366|Drug|Basal Bolus|Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed
16120905|NCT02004366|Drug|Linagliptin|Patients with admission A1C < 7% will be discharged on same pharmacologic regimen (oral agents, insulin therapy) or linagliptin 5 mg/day for 3 months.
16120906|NCT02004366|Drug|Linagliptin + 50% Glargine dose on discharge|Patients with admission HbA1c between 7% and 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 50% of daily hospital dose for 3 months.
16120907|NCT02004366|Drug|Linagliptin + 80% Glargine|Patients with admission HbA1c ≥ 9% will be discharged on previous oral anti-diabetic agents plus linagliptin, and consider glargine insulin at 80% of daily hospital dose for 3 months.
16120908|NCT02004353|Device|Cochlear® Hearing Implants|Market approved hearing implants including: Nucleus Cochlear implants, Nucleus Auditory Brainstem Implants, Cochlear Baha implants, Cochlear Acoustic Implants
16120909|NCT02004340|Device|ear vagus nerve stimulator|
16120910|NCT02004327|Drug|DW1029M300mg|DW1029M300mg PO Once
16120911|NCT02004327|Drug|DW1029M600mg|DW1029M300mg 2 tablets Once
16120912|NCT02004327|Drug|DW1029M1200mg|DW1029M300mg 4 tablets PO Once
16120913|NCT02004314|Drug|Chloroquine|
16120914|NCT02004301|Drug|Radiolabelled T4 Tablet|
16120915|NCT02004301|Drug|Radiolabelled T6 Tablet|
16120916|NCT02004288|Dietary Supplement|Lactobacillus reuteri Protectis DSM17938|One chewable tablet with L. reuteri or placebo taken twice a day for 3 months. After the 3 month therapy both groups will be monitored for the next 3 months.
16120917|NCT02004275|Drug|pomalidomide|given PO
16120918|NCT02004275|Drug|ixazomib|given PO
16120919|NCT02004275|Drug|dexamethasone|given PO
16120920|NCT02004262|Biological|GVAX Pancreas Vaccine|
16120921|NCT02004262|Biological|CRS-207|
16120922|NCT02004262|Drug|Chemotherapy|Investigator's choice of one of the following commercially available products: gemcitabine; capecitabine; fluorouracil with or without leucovorin; irinotecan; or erlotinib.
16120923|NCT02004262|Drug|cyclophosphamide|
16120924|NCT02004236|Device|tRNS Fronto-temporal cortex|This group receive 35 sessions of tRNS over fronto-temporal cortex
16120925|NCT02004236|Device|tRNS over fusiform temporal cortex|This group receive 35 sessions of tRNS over fusiform temporal cortex
16120926|NCT02004236|Device|tRNS with sham|the subjects receive 35 session with sham
16120927|NCT02004223|Radiation|Dose escalation using stereotactic boost|"This is a dose escalation study. Participants will be allocated to the current dose level, or if the current dose level has been filled and acceptable toxicity has been established, they will be enrolled into the next dose level.
~The first dose level will be 20Gy in 2 fractions to PTV and 25Gy to Gross Target Volume (GTV) if identified. The second dose level will be 22Gy in 2 fractions to PTV and 27.5Gy to GTV if identified. The dose level will be 24 Gy in 2 fractions to PTV and 30Gy to GTV if identified.
~Following stereotactic boost, all participants will receive 46Gy in 23 fractions radiotherapy to the prostate / seminal vesicles +/- lymph nodes."
16120928|NCT02004210|Procedure|transarterial radioembolization (TARE)|transarterial radioembolization
16120929|NCT02004210|Procedure|transarterial chemoembolization (TACE)|transarterial chemoembolization
16120930|NCT02004197|Drug|Quadruple Allopathic therapy|
16120931|NCT02004197|Drug|Pylorex plus|
16120932|NCT02004184|Drug|maintenance pemetrexed|500 mg/m2 Body Surface Area is administered intravenously every 3 weeks
16120933|NCT02004184|Drug|pemetrexed at progression|500 mg/m2 Body Surface Area is administered intravenously every 3 weeks
16120934|NCT02004171|Other|electronic cigarette|V2 Cigs with 24 mg nicotine cartridges
16120935|NCT02004171|Drug|nicotine inhaler|nicotine inhaler with 10 mg nicotine cartridges
16120936|NCT02004158|Behavioral|Positive psychology intervention|
16120937|NCT02004145|Behavioral|Positive Psychology|The Positive Psychology intervention consists of 6 exercises that will be completed by the participant with the guidance of a trainer.
16120938|NCT02004145|Behavioral|Control Condition|The Control Condition consists of 6 exercises that will be completed by the participant with the guidance of a trainer.
16120939|NCT02004132|Drug|Axiron|Solution administered topically using pump and applicator
16120940|NCT02004119|Drug|KHK4577|
16120941|NCT02004119|Drug|Placebo|
16120942|NCT02004106|Drug|RO6895882|Participants will receive RO6895882 at different dose levels and schedules defined in respective arms as IV infusion.
16120943|NCT02004093|Drug|pertuzumab|Loading dose of 840 mg IV, followed by 420 mg IV every 3 weeks
16120944|NCT02004093|Drug|paclitaxel|175 mg/m2 IV every 3 weeks for 6 cycles
16120945|NCT02004093|Drug|gemcitabine|1000 mg/m2 IV Day 1 and 8 of each cycle for 6 cycles
16120946|NCT02004093|Drug|carboplatin|Target AUC of 5 following paclitaxel or AUC of 4 following gemcitabine IV every 3 weeks for 6 cycles
16120947|NCT02004080|Other|Intensive Care treatment|intensive care treatment
16120948|NCT02004067|Drug|Restasis|Restasis is an ophthalmic emulsion containing cyclosporine 0.5 mg/mL, produced by Allergan Inc.
16120949|NCT02004067|Drug|Refresh Endura|Refresh Endura is a topical lubricant produced by Allergan, Inc.
16120950|NCT02004054|Other|measure of pupil diameter|The measure will use infra-red cameras
16120951|NCT02004041|Drug|VLY-686|capsules containing 50 mg VLY-686
16120952|NCT02004041|Drug|Placebo|Sugar capsule to mimic VLY-686 50 mg capsule
16120953|NCT02004028|Drug|VS-6063|
16120954|NCT02004015|Drug|injection of placebo|0.5 mg/kg milligram(s)/kilogram
16120955|NCT02004015|Drug|injection of NMBA|
16120956|NCT02004002|Behavioral|Weight maintenance with normal protein intake|Control group will consume 1.4 g/kg/d of protein; consistent with the average protein intake in the US population.
16121423|NCT02000050|Procedure|TME (Total Mesorectal Excision)|TME (Total Mesorectal Excision)
16120957|NCT02004002|Behavioral|Weight maintenance with protein restriction|Protein restriction group will receive the Institute of Medicine RDA of 0.8 g protein/kg body wt/d.
16120958|NCT02003989|Other|ophthalmologic examination and MRI|thorough investigation of patients, not included in usual care.
16120959|NCT02003976|Procedure|Medial Opening Wedge High Tibial Osteotomy (HTO)|A lower limb realignment surgery to redistribute load away from the most affected portion of the knee.
16120960|NCT02003976|Other|Non-Surgical Treatment Program|A 12-week optimized non-surgical treatment program consisting of medication, physiotherapy and nutritional seminars.
16120961|NCT02003963|Behavioral|Klub Kinect|"Dance Central and Just Dance are a series of rhythm games developed by Harmonix Music Systems exclusively for the Xbox 360 Kinect. The Dance Central suite of games (Dance Central 1, 2, and 3) and Just Dance will be played on the Xbox 360+ Kinect gaming console, which employs whole body movement using an infrared sensor that tracks body movements such that an external controller device is not required. The player performs dance moves demonstrated by on-screen characters and set to popular music, with a choice of over 650 dance moves, 90 dance routines, and over 300 songs.
~The exergaming condition will wear a pedometer to record total steps during game play, and they will participate in private weigh-ins at each session to track body weight over the 12-week intervention."
16120962|NCT02003950|Other|Snack Condition Specification|Individuals recieve a different snack for every week of the study. This is viewed as 4 phases. Phase 1 measures of habitual chocolate candy consumption (1 week), Phase 2 assesses participants' chocolate consumption while anticipating an oncoming chocolate candy restriction (1 week), Phase 3 is the total chocolate candy restriction period, but participants will be given 3 non-chocolate-candy snack substitutes in a random order (1 week per snack type, 3 weeks total), and Phase 4 examines participants' chocolate candy consumption when the 3-week restriction is lifted (1 week).
16120963|NCT02003937|Behavioral|Aerobic conditioning|Subjects performed 12 weeks of aerobic training on a stationary cycle ergometer. Subjects compleeted a total of 42 training sessions of 30min. exercise at an individually adjusted moderate workload.
16120964|NCT02003924|Drug|Enzalutamide|160 mg by mouth once daily
16120965|NCT02003924|Drug|Placebo|Sugar pill to mimic enzalutamide
16120966|NCT02003911|Drug|Azithromycin|Azithromycin suspension (200mg/5mL)
16120967|NCT02003911|Drug|Placebo|
16120968|NCT02003898|Device|Medtronic MiniMed 530G Insulin Pump|
16120969|NCT02003885|Drug|increment of desflurane|"After achieving stable hemodynamics and BIS 40-60 with desflurnae 0.5 MAC and remifentanil 0.7-1.0 mcg/kg/min (T1), data including S', E', A', EF, E, A and BIS are determined.
~After 10 min exposure to the increased desflurane dosage 1.0 MAC (T2), data are determiend. After 10 min exposure to the increased desflurane dosage 1.5 MAC (T3), data are determined.
~Reduction of BP is managed by the increment of phenylephrine infusion"
16120970|NCT02003872|Device|Spatz 3 intragastric balloon|Intra gastric balloon implanted using gastroscopy
16120971|NCT02003833|Device|Poly-L-lactic acid|Sculptra injections
16120972|NCT02003833|Device|Placebo comparator|saline injections
16120973|NCT02003820|Behavioral|video modeled social story|Patient will watch a Youtube compatible video of a child in the same age range as the study participants demonstrating proper brushing technique. The video will be paired with written subtitles created using the Social Story format. The subtitles will be read to the participant as the video plays. The patient will watch the video immediately before each brushing session morning and night for the three week intervention. After the intervention period the video will be made available on Youtube.com for the participants to use as they wish.
16120974|NCT02003794|Drug|0.9% NaCl solution|0.9% NaCl solution intravenous infusion: 100 ml/hr for three days.
16120975|NCT02003768|Drug|Propofol|80 patients are randomly allocated into two groups: In TIVA group, propofol based total intravenous anesthesia is used to induce and maintain anesthesia for laparoscopic cholescystectomy.
16120976|NCT02003768|Drug|Desflurane|80 patients are randomly allocated into two groups : In Des group, inhalation anesthesia using desflurane is used to induce and maintain anesthesia for laparoscopic cholescystectomy.
16120977|NCT02003755|Procedure|Ankle continuous passive motion machine.|A rehabilitation program of machine driven passive stretch.
16120978|NCT02003742|Drug|NX-1207|Single TRUS-guided intraprostatic injection of 2.5 mg of NX-1207
16120979|NCT02003742|Drug|Tamsulosin|1 film coated, prolonged release tablet of tamsulosin 0.4 mg, to be taken orally (p.o.) QD
16120980|NCT02003729|Device|Portable Sleep Monitor|ApneaDx™ is a new PM that uses a microphone to record breath sounds and an acoustical analysis algorithm of breath sounds to determine the AHI.
16120981|NCT02003703|Biological|Recombinant Hepatitis B Virus Vaccine|
16120982|NCT02003690|Behavioral|Dialectical Behavior Therapy|Dialectical Behavior Therapy
16120983|NCT02003690|Behavioral|Standard of Care Psychotherapy|Standard of Care Psychotherapy
16120984|NCT02003690|Drug|Pharmacotherapy|Standard of Care Pharmacotherapy
16120985|NCT02003677|Drug|Faster-acting insulin aspart|Subjects - in a euglycaemic clamp setting - will receive a single dose. The trial products will be administered subcutaneously (s.c. under the skin).
16120986|NCT02003677|Drug|insulin aspart|Subjects - in a euglycaemic clamp setting - will receive a single dose. The trial products will be administered subcutaneously (s.c. under the skin).
16120987|NCT02003664|Drug|Baclofen ER|Comparison of Baclofen ER to placebo using a 2 to 1 chance of receiving Baclofen ER, the medication
16120988|NCT02003664|Drug|Placebo|Comparison of placebo to Baclofen ER using a 1 in 3 chance of receiving placebo
16120989|NCT02003651|Dietary Supplement|Quick Defense|Echinacea product from Gaia Herbs.
16120990|NCT02003651|Dietary Supplement|Placebo|Placebo
16120991|NCT02003638|Drug|Niacin|Niacin titrated to 6000 mg daily
16120992|NCT02003638|Drug|Placebo|Placebo provided in the same pill quantity as niacin arm
16120993|NCT02003625|Drug|GCSF|
16120994|NCT02003625|Drug|meloxicam|
16120995|NCT02003625|Drug|Placebo|
16120996|NCT02003612|Other|Not applicable - observational study|No intervention exists as this is a retrospective observational study
16120997|NCT02003599|Device|Laser therapy|The low level laser therapy used in this trial will be Photon Lase III (DMC, approved by ANVISA for medicinal purposes). This InGaAIP laser emits a pulsed 660 nanometer beam with an average output of 80 milliwatts and the average energy density delivered to the breast will be 3 J/cm2.
16120998|NCT02003599|Device|Placebo|In the control group, 26 patients will be submitted to a laser, but the laser will be disabled without affecting its apparent function , five days a week before radiotherapy .
16120999|NCT02003586|Dietary Supplement|plant-based ingredient|
16121000|NCT02003586|Dietary Supplement|No plant-based ingredient|
16121001|NCT02003573|Drug|decitabine iv|decitabine iv fixed dose
16121002|NCT02003573|Drug|volasertib iv infusion|volasertib iv infusion (Body Surface Area (BSA) based dosing)
16121003|NCT02003560|Radiation|accelerated partial breast irradiation|9 x 4.1 Gy accelerated partial breast irradiation delivered by 3D-CRT or IMRT over 5 consecutive days, using twice-a-day fractionation.
16121004|NCT02003547|Drug|AMA0076|
16121005|NCT02003547|Drug|Placebo|
16121006|NCT02003534|Drug|0.15% Brimonidine Tartrate|0.15% Brimonidine Tartrate (Alphagan® P) 1 drop in the affected eye 3 times daily for 3 months.
16121007|NCT02003521|Device|Lung Flute|A low frequency wave is generated at the mouth by exhaling through a mouthpiece over a laminar surface (Reed) inside the Lung Flute®. The resulting low frequency acoustic wave that is produced travels retrograde into the lower airways and lung parenchyma and increases mucociliary clearance. Patients expel air with the force required to blow out a single candle. Patients concentrate on producing a low tone through the device while breathing in a proscribed pattern. Twenty repetitions of a single two-breath pattern are performed with the device to complete a diagnostic session.
16121008|NCT02003495|Biological|MCV-ACYW135 Vaccine Group|0.5ml, intramuscular
16121009|NCT02003495|Biological|MPV-ACYW135 Vaccine Group|0.5ml, intramuscular
16121010|NCT02003495|Biological|MPV-A Vaccine Group|0.5ml, intramuscular
16121011|NCT02003495|Biological|MCV-AC Vaccine Group|0.5ml, intramuscular
16121012|NCT02003495|Biological|Hib Vaccine Group|0.5ml, intramuscular
16121013|NCT02003482|Radiation|Postop IMRT for head/neck cancer|Patients will be enrolled in study through the duration of their radiation therapy, approximately 6-8 weeks. After which time no further evaluations will be made.
16121014|NCT02003482|Device|CT for Radiation Treatment Planning|Treatment planning CT scans will be required to define tumor, clinical, and planning target volumes. This study requires CT scans prior to initiation of treatment then again on the third and sixth week of radiation treatment
16121015|NCT02003469|Device|Ambulatory Blood Pressure Monitoring|All enrolled patients have an ambulatory blood pressure monitor placed, pre-transplant/donation, again at 3 months and finally at 12 months post-transplant/donation to measure blood pressure and blood pressure patterns
16121016|NCT02003456|Drug|Cardiac PET scan w/18F-Fluorodeoxyglucose and rubidium-82|Study subjects will undergo a Cardiac PET scan that will take approximately 20 minutes to complete. In addition to standard clinical rubidium-82/18F-fluorodeoxyglucose (FDG) PET imaging, during a separate imaging session, participants will be infused with a second dose of the radio-tracer rubidium-82 during FDG imaging scan that will take an additional 10 to 15 minutes to complete.
16121017|NCT02003443|Behavioral|Self-Administered Acupressure|The intervention involves teaching and supporting subjects to administer acupressure on themselves.
16121018|NCT02003404|Device|Control Abdominal Skin|Three barrier materials will be peeled from abdominal skin after a set period at a set rate.
16121019|NCT02003404|Device|Peristomal Abdominal Skin|Three barrier materials will be peeled from abdominal skin after a set period at a set rate.
16121020|NCT02003391|Drug|Beta-blocker monotherapy|Per participant's current prescribed therapy
16121021|NCT02003391|Drug|Travoprost 0.004% / timolol 0.5% fixed combination ophthalmic solution|
16121022|NCT02003378|Device|Pacemaker sensor set to MV|Pacemaker sensor set to minute ventilation
16121023|NCT02003378|Device|Pacemaker sensor set to XL|Pacemaker sensor set to accelerometer
16121024|NCT02003365|Drug|FX006 10 mg|Extended-release formulation
16121025|NCT02003365|Drug|FX006 40 mg|Extended-release formulation
16121026|NCT02003365|Drug|TCA IR 40 mg|Immediate-release formulation
16121027|NCT02003352|Procedure|Functional Neurological Rehabilitation|Functional Neurological Rehabilitation Includes vestibular rehabilitation and physical rehabilitation. Vestibular rehabilitation utilizes strategies that involves movement of the head and eyes at various speeds and directions while the subject looks at a target. Physical rehabilitation involves exercises to increase mobility and increase strength.
16121028|NCT02003339|Other|Additional RMIs|
16121029|NCT02003326|Other|Inflammatory markers|
16121030|NCT02003313|Biological|Group T|0.5ml, Intramuscular
16121031|NCT02003313|Biological|Group C|0.5ml, Intramuscular
16121032|NCT02003287|Other|VFSS|Videofluoroscopic Swallow Study
16121033|NCT02003287|Other|FEES|Fiberoptic Endoscopic Swallow Study
16121034|NCT02003274|Other|Clamp-Mixed Meal|"Standard clinical parameters will be assessed in all patients.
~Metabolic tests:
~A. Euglycemic insulin clamp. A standard euglycemic insulin clamp will be carried out in type 1 diabetic patients to assess insulin sensitivity, as previously described (1).
~B. Mixed meal test. All participants will ingest a standardized mixed meal and will be monitored for 300 minutes thereafter. Right before meal ingestion, a s.c. fast insulin analogue bolus will be administered by the pump
~This test will determine the time courses of:
~1. plasma glucose, 2. 13C/12C glucose ratio (hence, meal-derived and endogenous glucose), 3. insulin, 4. free fatty acids, 5. aminoacids, 6. glucagon, 7. incretin hormones 8. glucose control coefficients (CCs) during a mixed meal."
16121035|NCT02003274|Other|IVGTT-Mixed Meal Arm|"Standard clinical parameters will be assessed in all subjects.
~Metabolic tests:
~A. IVGTT. A frequently sampled intravenous glucose tolerance test (IVGTT) in healthy controls will be carried out in study 1 and study 3 to assess insulin sensitivity.
~B. Mixed meal test. All participants will ingest a standardized mixed meal and will be monitored for 300 minutes thereafter.
~This test will determine the time courses of:
~1. plasma glucose, 2.13C/12C glucose ratio (hence, meal-derived and endogenous glucose), 3. insulin, 4. free fatty acids, 5. aminoacids, 6. glucagon, 7. incretin hormones 8. glucose control coefficients (CCs) during a mixed meal."
16121121|NCT02002650|Drug|Post-operational Rectal Indomethacin|Rectal Indomethacin was administrated immediately after ERCP in high-risk patients, while average risk patients did not.
16121122|NCT02002637|Device|Latella Knee Implant System|
16121123|NCT02002624|Device|PSI|
16121124|NCT02002624|Device|Conventional instrumentation|
16121125|NCT02002611|Drug|Lobeglitazone|
16121126|NCT02002611|Drug|Warfarin|
16121036|NCT02003261|Behavioral|Unified Protocol with Treatment As Usual|"Unified Protocol(UP) is a transdiagnostic cognitive-behavioral therapy for depressive and anxiety disorders, which is developed by Dr. Barlow and his colleagues at Boston university.
~UP is weekly, face to face, individual psychotherapy consisting of 9 to 20 sessions. Average session number is 16 sessions. Contents of the treatment includes motivational enhancement, psychoeducation of treatment rationale and emotion, emotion awareness training, cognitive reappraisal, avoidance and emotion driven behaviors, interoceptive exposure and emotion exposure."
16121037|NCT02003261|Other|Treatment As Usual|Most of the TAU will be drug therapy or nonsystematic supportive psychotherapy.
16121038|NCT02003248|Device|transcranial magnetic resonance guided focused ultrasound pallidotomy|Focused ultrasound is an attractive method for non-invasive thermal ablation of soft tissue, including functional brain targets. Treatment begins by acquiring a series of MR images of the target organ. The physician then identifies a target volume in the MR images, and delineates the treatment contours on the images. Therapy planning software calculates the parameters required to effectively treat the defined target volume. During the treatment, an ultrasound transducer generates a point of focused ultrasound energy, called a sonication. The sonication raises the tissue temperature within a well-defined region, enabling neurophysiological assessment in the low range, and thermal coagulation at higher ranges. MR images acquired during sonication provide a quantitative, real-time temperature map of the target area to confirm the location of the sonication and the size of the affected region.
16121039|NCT02003235|Device|Daily watching videos using Reviview™, a dichoptic video display device, for 60 min|
16121040|NCT02003222|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic hematopoietic SCT
16121041|NCT02003222|Biological|Blinatumomab|Given IV
16121042|NCT02003222|Drug|Cyclophosphamide|Given IV
16121043|NCT02003222|Drug|Cytarabine|Given IT, IV, or SC
16121044|NCT02003222|Drug|Daunorubicin|Given IV
16121045|NCT02003222|Drug|Daunorubicin Hydrochloride|Given IV
16121046|NCT02003222|Drug|Dexamethasone|Given PO
16121047|NCT02003222|Drug|Etoposide|Given IV
16121048|NCT02003222|Other|Laboratory Biomarker Analysis|Correlative studies
16121049|NCT02003222|Drug|Mercaptopurine|Given PO
16121050|NCT02003222|Drug|Methotrexate|Given PO, IT or IV
16121051|NCT02003222|Drug|Pegaspargase|Given IM or IV
16121052|NCT02003222|Drug|Prednisone|Given PO
16121053|NCT02003222|Biological|Rituximab|Given IV
16121054|NCT02003222|Drug|Vincristine|Given IV
16121055|NCT02003222|Drug|Vincristine Sulfate|Given IV
16121056|NCT02003209|Drug|Aromatase Inhibition Therapy|Given at the investigator's discretion
16121057|NCT02003209|Drug|Carboplatin|Given IV
16121058|NCT02003209|Other|Cytology Specimen Collection Procedure|Undergo 2 core biopsies
16121059|NCT02003209|Drug|Docetaxel|Given IV
16121060|NCT02003209|Drug|Goserelin Acetate|Given SC
16121061|NCT02003209|Other|Laboratory Biomarker Analysis|Correlative studies
16121062|NCT02003209|Biological|Pertuzumab|Given IV
16121063|NCT02003209|Other|Quality-of-Life Assessment|Ancillary studies
16121064|NCT02003209|Procedure|Therapeutic Conventional Surgery|Undergo lumpectomy or mastectomy
16121065|NCT02003209|Biological|Trastuzumab|Given IV
16121066|NCT02003209|Radiation|Whole Breast Irradiation|Undergo whole breast irradiation
16121067|NCT02003183|Radiation|[F-18]FDDNP|Each participant was injected with [F-18]FDDNP, a radiolabeled molecular imaging probe, prior to receiving a PET scan.
16121068|NCT02003157|Procedure|hypnosis during embryo transfer or usual transfer procedure|
16121069|NCT02003144|Biological|eculizumab|
16121070|NCT02003131|Biological|Trophic factors from umbilical cord mesenchymal stem cells|
16121071|NCT02003118|Drug|AKR 202|
16121072|NCT02003118|Drug|Placebo|
16121073|NCT02003092|Drug|RX-5902|escalating doses (mg)
16121074|NCT02003079|Behavioral|Cystic Fibrosis Questionnaire (Revised) for Teens/Adults|
16121075|NCT02003066|Procedure|Standard fluid therapy|In Standard fluid therapy group, the administration of fluid will be guided to maintain mean blood pressure more than 65 mmHg, urine output more than 0.5 ml/kg/hr, and central venous pressure less than 14 mmHg.
16121076|NCT02003066|Procedure|Conservative fluid therapy|In Goal directed fluid therapy group, the administration of fluid will be guided by stroke volume variation. The anesthesiologist will infuse volulyte (Fresenius Kabi, Bad Homburg, Germany) 200 ml if stroke volume variation is over 12%. If cardiac index is below 2.5 l/min/m2 and stroke volume variation is below 12%, start dobutamine.
16121077|NCT02003053|Device|Inspiratory Muscle Trainer|
16121078|NCT02003040|Device|Mespere Venus 1000 CVP System|An adhesive patch (connected to the Mespere Venus 1000 System) is placed on the neck of the subject. A CVP measurement is recorded at time of patient's hospital admission and discharge. CVP readings will remain concealed from the treating team.
16121079|NCT02003027|Drug|BT injection|
16121080|NCT02003014|Drug|Pioglitazone|Pioglitazone Tablets
16121081|NCT02003001|Drug|Botulinum Toxin|
16121082|NCT02002988|Procedure|endomyocardial BT injection|
16121083|NCT02002975|Drug|Pioglitazone|Pioglitazone tablets
16121084|NCT02002962|Procedure|radiofrequency ablation|
16121085|NCT02002962|Drug|Botulinum Toxin Type A injection|
16121086|NCT02002949|Procedure|Short daily hemodialysis|5 or 6 treatments per week for approximately 3 hours (range 2 to 4 hours) per treatment, to be performed at the patient's home, using any hemodialysis machine as chosen by the responsible clinician in each participating center
16121087|NCT02002949|Procedure|Conventional hemodialysis|3 treatments per week for approximately 4 hours (range 3 hours and 30 minutes to 4 hours) per treatment, to be performed in a dialysis clinic using any hemodialysis machine as chosen by the responsible clinicians in each participating center
16121127|NCT02002598|Drug|Bendamustine|"Bendamustine will be administered IV on days 1 and 2 with dose escalation up to 90 mg/m2 of each 28-day cycle.
~Dose escalation is as follows:
~-1 | 60 mg/m2
~| 70 mg/m2
~| 70 mg/m2
~| 90 mg/m2
~| 90mg/m2
~| 90 mg/m2"
16121128|NCT02002598|Drug|Carfilzomib|"Carfilzomib will be administered IV on Days 1, 2, 8, 9, 15, and 16 every 28 days.
~Dose Escalation is as follows:
~-1 | 27 mg/m2
~| 27 mg/m2
~| 36 mg/m2
~| 36 mg/m2
~| 45 mg/m2
~| 56 mg/m2"
16121088|NCT02002936|Drug|SyB C-1101|"SyB C-1101（rigosertib sodium） will be administered orally twice daily for 14 consecutive days, followed by 7-day observation period. The treatment period of 21 days (14 days of administration + 7 days of observation) constitutes 1 cycle.
~The dose at cycle 6 in the study 2012002 will be the dose (if needed, the dose can be reduced) at the first cycle in this study (cycle 7).
~From cycle 8 on, the dose of SyB C-1101 will be reduced, delayed, or discontinued according to adverse events and results of observation at the previous cycle."
16121089|NCT02002923|Procedure|Pulmonary vein isolation|The left atrium (LA) and pulmonary veins (PVs) are explored through a transeptal approach. Real-time 3D LA maps are reconstructed by using a nonfluoroscopic navigation system. The ipsilateral left and right PVs are encircled in one lesion line by circumferential PV isolation. Radiofrequency energy is delivered at 43°C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and is reduced to 43°C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation speed of 17 mL/min. Each lesion is ablated continuously until the local potential amplitude decreased by >80% or RF energy deliveries exceeded 40 s. The endpoint of circumferential PV isolation is PV isolation. Additional ablation lines are created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the roof of the LA between the two superior PVs. After the end of the procedure the implantable loop recorder is implanted in the parasternal area of the chest.
16121090|NCT02002923|Drug|Botulinum Toxin|Transseptal puncture is performed by used standard endovascular approach. Injection of the botulinum toxin is performed in main anatomical zones of ganglionated plexuses of left atrium using Myostar catheter (Biosense Webster).
16121091|NCT02002897|Device|Fractional carbon dioxide laser|Fractional carbon dioxide laser (10,600 nm), a session once per month, total of 3 sessions with full clinical evaluation and investigations before and one month after the last session of treatment.
16121092|NCT02002897|Device|Ultraviolet A1 phototherapy (UVA1)|localized UVA1 phototherapy (340-400 nm), low dose irradiation, at a rate of 3 sessions per week , total of 24 sessions with full clinical evaluation and investigations before and after treatment and clinical follow up one month after treatment.
16121093|NCT02002884|Drug|IncobotulinumtoxinA (8 Units per kg body weight)|Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl); Mode of administration: intramuscular injection into spastic muscles.
16121094|NCT02002884|Drug|IncobotulinumtoxinA (6 Units per kg body weight)|Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl); Mode of administration: intramuscular injection into spastic muscles.
16121095|NCT02002884|Drug|IncobotulinumtoxinA (2 Units per kg body weight)|Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl); Mode of administration: intramuscular injection into spastic muscles.
16121096|NCT02002871|Device|PSO-CT02 device|The PSO-CT02 device is worn on the affected skin area where it irradiates the target Eczema area for 30 minutes with blue light. A contralateral eczema area is left untreated and serves as control.
16121097|NCT02002858|Drug|Nicotine Patch|
16121098|NCT02002858|Behavioral|Depression and Anxiety Smoking Cessation Treatment|Cognitive-behavioral treatment program that blends smoking cessation, anxiety, and depression management/reduction treatment strategies
16121099|NCT02002858|Behavioral|Educational-Support Psychotherapy|Educational-based psychotherapy and standard smoking cessation treatment program
16121100|NCT02002845|Device|robotic surgery using the da Vinci Surgical System|
16121101|NCT02002832|Drug|Lurasidone tablets|Lurasidone tablets (40or80mg/day) and Risperidone tablets(Placebo)
16121102|NCT02002832|Drug|Risperidone tablets|Risperidone tablets(2-6mg/day) and Lurasidone tablets(Placebo)
16121103|NCT02002819|Drug|levetiracetam|
16121104|NCT02002806|Other|Alcohol Injection|Celiac plexus neurolysis by alcohol injection
16121105|NCT02002806|Other|Placebo Injection|
16121106|NCT02002793|Other|Early stage abdominal drainage|Ultrasound/CT/GUS guided abdominocentesis and drainage with single-chamber deep venous catheters shoule be implemented and the catheter should be removed when abdominal drainage flow≤100ml in two successive days;
16121107|NCT02002793|Other|Late stage abdominal drainage|Despite that it matches one of the cirteria as the study group:1．Intravesical pressure≥20cmH2O or 2．CT scan:acute peripancreatic liquid collection, the patients continue acquire prearranged integrative treatment and will not accept early stage abdominal drainage until any of the followings emerge:1.Intra-abdominal apartment syndrome; 2. Pancreatic pseudocyst;3. Pancreatic or peripancreatic necrosis;
16121108|NCT02002780|Behavioral|Day Camp|"The intervention will be delivered using a day camp structure, on a weekend or during school break in July 2011. Separate interventions will be offered for boys and girls. Each intervention will include two full days (0900 to 1600) of group activities lead by the researchers. Details of the camp activities will be developed by the researchers, based on the types of psychosocial stress identified during the screening phase of the project."
16121109|NCT02002767|Drug|Velpatasvir|Velpatasvir 100 mg (2 x 50 mg tablets) administered orally
16121110|NCT02002754|Drug|Bambuterol Hydrochloride tablets|Bambuterol Hydrochloride tablets(10mg) 3 tablets qd for three days(swallowed by warm water at 0.5-1h after each meal)
16121111|NCT02002741|Drug|Paracetamol|Ibuprofen 3 doses administered q24h + Paracetamol 12 doses administered q 6h
16121112|NCT02002741|Drug|Placebo|Ibuprofen 3 doses administered q24h + Placebo : 12 doses administered q 6h
16121113|NCT02002715|Drug|Inhaled budesonide|inhaled Budesonide 2puff Q12h,total 400µg/day for 4 weeks inhaled Budesonide 2puff Q12h,total 400µg/day for 8 weeks inhaled Budesonide 2puff Q12h,total 400µg/day for 16 weeks
16121114|NCT02002702|Drug|Serelaxin|Intravenous infusion
16121115|NCT02002702|Drug|Placebo|Placebo
16121116|NCT02002689|Drug|LDE225|LDE225 800 mg (hard gelatin capsules) will be administered orally once daily on a continuous dosing schedule
16121117|NCT02002663|Drug|ropivacaine 0.2%|PCA morphine 0.5 mg/ml bolus 1 mg LO 5 min max 20 mg in 4 hs
16121118|NCT02002663|Drug|Methylprednisolone 1mg/kg|
16121119|NCT02002663|Drug|saline 0.9%|
16121120|NCT02002650|Drug|Pre-ERCP rectal Indomethacin|Rectal Indomethacin was administrated within 30min before ERCP in all patients.
16121197|NCT02001948|Drug|intrathecal morphine 0.4 mg combined with intrathecal heavy bupivacaine 7.5 mg|
16121129|NCT02002598|Drug|Dexamethasone|Dexamethasone will be administered PO or IV, 20 mg, on 1, 2, 8, 9, 15, 16 and 22, 23 of each 28-day cycle.
16121130|NCT02002585|Procedure|Renal denervation|Catheter based renal sympathetic denervation is a endovascular method used for the treatment of resistent hypertension.
16121131|NCT02002572|Other|Magnetic Resonance Imaging (MRI), Surface scan, Motion capture, Digital Image Correlation|
16121132|NCT02002533|Behavioral|Brief Behavioral Therapy|Undergo BBT intervention
16121133|NCT02002533|Behavioral|Telephone-Based Intervention|Undergo BBT intervention
16121134|NCT02002533|Other|Educational Intervention|Undergo HEAL
16121135|NCT02002533|Behavioral|Telephone-Based Intervention|Undergo HEAL
16121136|NCT02002507|Other|comparison of different neurosurgical position|in 2 of 3 positions (supine, plus either prone or park bench) with both left and right internal jugular vein cross-sectional area of vein, doppler velocity, internal jugular venous flow, position of internal jugular vein in relation to carotid artery (All measured with the use of ultrasound)
16121137|NCT02002494|Other|Different positions|Jugular venous blood flow in healthy volunteers in 3 different positions- supine, prone and park bench
16121138|NCT02002481|Other|transport|The manikin will be resuscitated during a transport in a vessel by a professional team (emergency physician / paramedic).
16121139|NCT02002468|Other|Test result sent by letter|
16121140|NCT02002468|Other|Test result conveyed by general practitioners|
16121141|NCT02002455|Device|PET/CT, PET/MRI, mpMRI|FACBC dose 370 megabecquerel (MBq)
16121142|NCT02002442|Other|Mouthwash|An investigator will give the patient the assigned mouthwash based on the randomized group allocation. 30ml of the mouthwash will be given to the subject in a sterilized calibrated tube. The subject will be asked to rinse for 60 seconds. Then, the patient will spit the mouthwash.
16121143|NCT02002429|Procedure|Intra-articular injection|Intra-articular injection into the affected facet joint(s) with 0.5 ml of a 50:50 solution containing 10 mg of depo-methylprednisolone and 0.5% bupivacaine. If the subject has a positive block a radiofrequency denervation will be performed at the affected joint.
16121144|NCT02002429|Procedure|Medial branch block|Medial branch blocks at the nerves that supply the affected facet joint(s) with 0.5 ml of a 50:50 solution containing 10 mg of depo-methylprednisolone and 0.5% bupivacaine. If the subject has a positive block a radiofrequency denervation will be performed at the affected joint.
16121145|NCT02002429|Procedure|Saline injection|Injection into the affected facet joint(s) with 0.5 ml of normal saline. All subjects in the group will receive radiofrequency denervation.
16121146|NCT02002403|Drug|Danazol|
16121147|NCT02002390|Drug|Fingolimod|A sphingosine-1-phosphate receptor regulator
16121148|NCT02002377|Drug|Aflibercept|Aflibercept 2 mg (0.05 mL or 50 microliters) will be administered by intravitreal injection every 4 weeks for the first 8 weeks, followed by 2 mg (0.05 mL) via intravitreal injection once every 8 weeks for 36 weeks
16121149|NCT02002364|Procedure|tracheal intubation|
16121150|NCT02002325|Drug|Tissue-type plasminogen activator (alteplase)|Intravenous tissue-type plasminogen activator (alteplase) 0.6mg/kg body-weight up to a maximum of 60 mg, 10% as bolus, 90% over 1 hour as infusion (plus other standard treatment if needed)
16121151|NCT02002325|Other|Standard care|Standard treatment for acute stroke without intravenous alteplase.
16121152|NCT02002312|Drug|Lu-177-DOTA-girentuximab|"Drug: In-111-DOTA-girentuximab At day 1, every patient received girentuximab at a dose of 10 mg coupled to DOTA and labeled with 5 mCi of In-111.
~Drug: Lu-177-DOTA-girentuximab At day 8-10, every patient receives girentuximab at a dose of 10 mg coupled to DOTA and labeled with 65 mCi/m2 of Lu-177. If eligible, patients are retreated at a dose 75% of the previous dose, for a total of not more than three treatments."
16121153|NCT02002286|Drug|Tripterygium Wilfordii Hook F extract (TwHF extract)|The extract Tripterygium wilfordii Hook F (TwHF), a traditional Chinese medication, has been used as anti-inflammatory therapy to treat autoimmune diseases including rheumatoid arthritis and Crohn's disease.
16121154|NCT02002286|Drug|cART|Participants who will be enrolled in this trial would keep their previous combined antiretroviral therapy, such as zidovudine or stavudine plus lamivudine plus nevirapine or efavirenz.
16121155|NCT02002273|Procedure|Switching level of suction|
16121156|NCT02002260|Device|Levonorgestrel intrauterine system|
16121157|NCT02002260|Drug|Combined oral contraceptives|
16121158|NCT02002247|Drug|sodium selenite|All subjects will receive an IV bolus of 2000µg selenium within 30min after induction of anesthesia via the central venous catheter. After termination of surgery, immediately after admission to the ICU, all patients will receive a second bolus of 2000µg selenium. Then on every further morning during ICU-stay, patients will receive an IV bolus of 1000µg selenium via central or peripheral venous access until death, discharge from ICU to the ward, or for a maximum of 10 days.
16121159|NCT02002247|Drug|Placebo|All patients will receive an IV bolus of normal saline (equals to 40ml prepared solution) within 30min after induction of anesthesia via the central venous catheter. After termination of surgery, immediately after admission to the ICU, all patients will receive a second bolus of normal saline accordingly. Then on every further morning during ICU-stay, patients will receive an IV bolus of normal saline via central or peripheral venous access until death, discharge from ICU to the ward (treatment may continue in a step down or intermediate care unit), or for a maximum of 10 days.
16121160|NCT02002234|Procedure|Hemicraniotomy|Hemicraniotomy involves removing a large bone flap at least 12 cm in diameter and included parts of the frontal, temporal, parietal and occipital bones, with further craniectomy to the floor of the temporal fossa. The dura was opened widely and duraplasty was performed using periosteum and temporalis fascia. The bone flap was either stored in a subcutaneous pocket in the abdomen or placed in the bone bank.
16121161|NCT02002234|Procedure|Standard medical treatment|Standard medical treatment involves elevation of the head of bed at 30°, intermittent hyperventilation administered, and intravenous mannitol. Mean arterial pressure was maintained above 90 mm Hg. Hemoglobin concentration was maintained at all times above 90 g/L.
16121162|NCT02002221|Drug|Vildagliptin (LAF237)|Corresponds to vildagliptin (LAF237) 50 mg tablets twice daily
16121163|NCT02002221|Drug|Placebo|Matching placebo of vildagliptin 50 mg twice daily
16121198|NCT02001948|Device|standard monitoring with Datex Ohmeda anesthesia monitor, GE, Finland|electrocardiography, heart rate, pulse oximetry and noninvasive arterial blood pressure
16121466|NCT01999829|Drug|placebo|
16121164|NCT02002221|Drug|Insulin|"Patients continued their prescribed insulin dose. The dose of insulin remained within a 10% increase of the baseline dose throughout the trial (with no change in frequency or insulin type) unless dose adjustments were required for safety reasons.
~The insulin dose was allowed to be decreased for safety reasons at anytime without specific dose limits at the Investigator's discretion."
16121165|NCT02002221|Drug|Metformin|Patients continued their prescribed metformin dose, if applicable.
16121166|NCT02002208|Drug|OC000459|Oral CRTH2 antagonist
16121167|NCT02002195|Drug|FOLFOX|Oxaliplatin 85 mg/m2 is given as a 2 hours intravenous infusion, concomitant to and S-leucovorin 200 mg/m2, and followed by 5-FU 2,400 mg/m2 as a 46 hours continuous infusion.
16121168|NCT02002195|Drug|Capecitabine|Capecitabine 1,000 mg twice a day will be administered until disease progression, unacceptable toxicity or treatment refusal by the patient.
16121169|NCT02002182|Biological|ADXS11-001 (ADXS-HPV)|ADXS11-001 (ADXS-HPV) is a live attenuated Listeria monocytogenes (Lm)-LLO immunotherapy developed for the treatment of HPV-associated dysplasia and malignancy.
16121170|NCT02002169|Other|Shower Technique Protocol|Video and educational pamphlets of the STP will be used to assist in training participants randomized to this intervention. The participant must successfully demonstrate the STP on a training mannequin and be deemed by the study coordinator as ready to independently and correctly perform it before proceeding.
16121171|NCT02002169|Other|Standard CVC Care|Nuanced differences may be present at participating units; however, the key components of the intervention are 1) HD nurse delivery of CVC care 2) chlorhexidine or povidone cleansing 3) dry gauze dressing 4) standardized frequency. For both STP and control arms, participants whose HD centre uses polysporin triple ointment as part of standard CVC care will continue to have it applied as per program policy.
16121172|NCT02002156|Biological|BCG, NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix®|This group will receive BCG at birth and all routine vaccinations.
16121173|NCT02002156|Biological|BCG, NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix®|This group will receive BCG at three months old and all routine vaccinations.
16121174|NCT02002156|Biological|NeisVac-C®, Pediacel®, Infanrix™, Prevenar-13®, Menitorix®, Priorix®, Rotarix®|This group will receive no BCG but will receive all routine vaccinations.
16121175|NCT02002143|Behavioral|Group Appointments|"Participants randomly assigned to the intervention group will participate in GAs of 8 patients for 1.5 hours, every 3 months for 2 years. The 3-member Care Team (MD, nurse, behaviorist) will attend each session. The nurse facilitates the session and curriculum. The MD responds to specific health questions. Patients may schedule time before or after to review their clinical results with the MD/nurse (e.g. HbAIC).
~Key elements include 1) completed pre-appt questionnaires used to identify a patient's educational needs; 2) patients use goal setting and action plans to initiate and maintain healthy behaviors; 3) each class has a designated purpose and learning objectives; 4) sessional feedback, which is used to adapt the next class (3 months later) based on patient needs."
16121176|NCT02002143|Behavioral|Individual Appointments (IAs)|"Participants randomly assigned to the IAs group will receive eight traditional 1-to-1 appointments, seeing their physician quarterly as per standard care in BC. They will be referred to ancillary services such as nutrition advice, counseling, and physical activity promotion according to 'usual care' practice. In addition, we will organize 4 1-hour social events for these participants annually. The 4 social events will be 1) a potluck lunch; 2) a movie night; 3) an event chosen by participants; and 4) a talent show. From our experience, these events enhance compliance to reporting and minimize dropouts. These events also serve to minimize 'socialization bias' that may otherwise potentially influence health measures including quality of life."
16121180|NCT02002117|Other|DNA mass|DNA mass spectrometry
16121181|NCT02002091|Other|no specific treatment|lifestyle counseling, antihypertensive drugs, antidiabetic drugs (oral and / or insulin)treatment of comorbidity or complications of diabetes.
16121182|NCT02002078|Drug|methylprednisolon|
16121183|NCT02002065|Biological|Inactivated HAV vaccine|Inactivated vaccine: 0.5 ml per dose containing 250 u antigen, one dose
16121184|NCT02002065|Biological|Attenuated alive HAV vaccine|Attenuated alive vaccine: 1.0 ml per dose containing 6.50 lgCCID50 alive virus, one dose
16121185|NCT02002052|Drug|Concurrent platinum-based chemotherapy|Platinum-based concurrent chemotherapy in both arms
16121186|NCT02002052|Radiation|Standard Radiotherapy, 60 Gy in 30 fractions.|
16121187|NCT02002052|Radiation|Functional Lung Avoidance Radiotherapy, 60 Gy in 30 fractions|
16121188|NCT02002039|Drug|Erythropoietin|500 units /kg /day every other day for 5 doses
16121189|NCT02002026|Procedure|Uterine artery ligation|Uterine artery ligation during cesarean section before delivery of the baby
16121190|NCT02002000|Drug|vitamin D (cholecalciferol)|Patients from the vitamin D arm will receive an orally supplementation of 600 000 UI cholecalciferol in 3 doses: 200 000 UI at baseline (day 1), 200 000 UI on day 15 and 200 000 UI on day 30. Cholecalciferol will be presented in blisters, in a non-differentiable form in appearance and taste from placebo, either for the patient or the doctor
16121191|NCT02002000|Drug|Placebo, similar in appearance and taste to cholecalciferol|Patients from the placebo arm will receive 3 doses of placebo to be taken orally: one at baseline (day 1), one on day 15, one on day 30. Placebo will be presented in blisters in a non-differentiable form in appearance and taste from cholecalciferol either for the patient or the doctor.
16121192|NCT02001987|Drug|Tocilizumab|Tocilizumab will be administered at a dose of 162 mg as SC injection once a week.
16121193|NCT02001987|Drug|Methotrexate|Methotrexate will be administered at a stable dose that was initiated at least 4 weeks prior to Baseline, at investigator's discretion.
16121194|NCT02001987|Drug|csDMARDs|csDMARDs (at investigator's discretion) will be administered at a stable dose that was initiated at least 4 weeks prior to Baseline, at investigator's discretion.
16121195|NCT02001974|Drug|Paclitaxel+Reparixin|Association of Paclitaxel at fixed dosage with three increasing dosage of Reparixin
16121196|NCT02001948|Drug|intrathecal morphine 0.1 mg combined with intrathecal heavy bupivacaine 7.5 mg|
16121199|NCT02001948|Drug|intravenous cannulation and premedication|18-gauge intravenous cannula was inserted at the forearm opposite to the surgical side and routine iv premedication (midazolam 0.03 mg/kg) was given
16121200|NCT02001935|Drug|theophylline|After oral theophylline 200mg per day for two weeks,bood sample will be collected for determining plasma concentrations of theophylline and it's metabolites and the genotypes of CYP1A2 and CYP2E1
16121201|NCT02001922|Other|COPD integrated care|The intervention will target COPD integrated care, and include a combination of patient-related, professional and organizational elements. It will be centered on patients' needs and focus on self-management education, proactive follow-up (scheduled visits and/or phone contacts), team work, healthcare professionals' training, promotion of pulmonary rehabilitation, physical activity and smoking cessation.
16121202|NCT02001909|Drug|Regorafenib (Stivarga, BAY73-4506)|single oral dose (s.d.) 160 mg (four 40 mg tablets) of regorafenib on two occasions (Day 1, Period 1, and Day 1, Period 2) separated by a washout period of at least 14 days
16121203|NCT02001909|Drug|Neomycin|1 g tid (three times a day) regimen of Neomycin (oral) on five days in Period 2 starting 4 days before regorafenib intake on day 1 in period 2.
16121204|NCT02001896|Drug|gemcitabine; cisplatin or carboplatin; erlotinib|
16121205|NCT02001896|Drug|erlotinib|
16121206|NCT02001883|Drug|Association low-dose statin and nutraceuticals|
16121207|NCT02001870|Procedure|In Vitro Fecundation (IVF)|In vivo fertilization will be performed according to the usual procedure of each Assisted Reproductive Technology (ART) center.
16121208|NCT02001870|Procedure|Intra Uterine Insemination (IUI)|Intra-uterine insemination will be performed according to the usual procedure of each ART center
16121209|NCT02001857|Drug|1 TachoSil hemostatic sponge (9,5 cm x 4,8 cm) placed on each side on the external iliac artery.|at the end of surgery
16121210|NCT02001844|Device|Trial Foot Orthoses (FOs)|"Trial Group:
~The children who were randomly introduced into this group received the pre-formed semi-rigid FOs. The FOs were used as an off the-shelf device and subsequently customised with chair side modifications. In order to reproduce the exact same aesthetical appearance as the control FOs, grey poron (1mm) and black EVA (0.75mm) was used as well to cover the trial FOs.
~Furthermore, depending on the type of correction applied to the trial patient, the black EVA also allowed the correction applied on the surface of the device to be masked."
16121211|NCT02001844|Device|placebo foot orthoses (FOs)|"The control FOs, or placebo FOs was supplied to patients who were randomly included in the control group. The control FOs was made of leather board (1mm), grey Poron (1mm), and black EVA (0.75mm) as covering. This thin inner sole did not have any sort of biomechanical support, nor had it any effect on the distribution of pressure, as it was completely flat. In addition, the placebo FOs did not present with any intrinsic or extrinsic correction underneath the sub-talar-joint (STJ).
~The use of black EVA as the covering material and the leather-board as a base, allowed for gathering of a dynamic impression over the 6 months of the trial."
16121212|NCT02001831|Dietary Supplement|Supplement|
16121213|NCT02001831|Dietary Supplement|Placebo|
16121214|NCT02001818|Drug|Nilotinib, Pegylated interferon alpha-2b, Imatinib|All patients joining the study will receive treatment with oral nilotinib at 300mg twice daily. This will be given as monotherapy for 3 months initially, prior to commencement of combination therapy with Pegylated interferon alpha-2b added to nilotinib. Patients intolerant of nilotinib will have the option of switching to imatinib.
16121215|NCT02001792|Procedure|Position the patient during colonoscopy|Position the patient either in a left lateral position during colonoscopy
16121216|NCT02001792|Device|pulse oximeter|
16121217|NCT02001779|Device|Biliary SEMS loaded with 125I seeds|A self-expandable metallic biliary stent loaded with 125 iodine seeds is inserted in patients with inoperable malignant biliary obstruction.
16121218|NCT02001779|Device|Conventional biliary SEMS|A self-expandable metallic stent is inserted in patients with inoperable malignant biliary obstruction.
16121219|NCT02001766|Behavioral|Exercise training|
16121220|NCT02001753|Device|CMR|
16121221|NCT02001740|Drug|Triamcinalone (steroid) and lidocaine|receive once
16121222|NCT02001740|Other|Lidocaine|receive once
16121223|NCT02001727|Other|13C-Urea breath test for Helicobacter Pylori|
16121224|NCT02001727|Other|Questionaire|
16121225|NCT02001714|Behavioral|Group Behavioral Treatment|Group Behavioral Treatment class is a two hour class taught by certified interventionist covering urinary system anatomy, bladder health and self management strategies, pelvic floor training, pelvic floor muscle contracting techniques, and bladder training. Slides and handouts supplement the content of the class.
16121226|NCT02001701|Procedure|Intravitreal Injection of sulfahexafluoride gas|After the appropriate sterile and anesthetic preparation of the surgical field, the investigator will administer a single intravitreal injection of 0.3 to 0.5 cc of sulfahexafluoride gas in the study eye. An anterior chamber paracentesis may be performed if necessary. Following the procedure, the optic nerve will be monitored for perfusion.
16121227|NCT02001688|Drug|Kamada-AAT for Inhalation, 80mg|
16121228|NCT02001688|Drug|Placebo|
16121229|NCT02001688|Drug|Kamada-AAT for Inhalation, 160mg|
16121230|NCT02001675|Device|magnetic resonance imaging (MRI)|
16121231|NCT02001675|Device|31-phosphorous magnetic resonance spectroscopy (MRS-P31)|
16121232|NCT02001662|Procedure|Intervention group, block no. 1 - Ropivacain|Intervention group: 1. block ropivacaine - 2. block saline
16121233|NCT02001662|Procedure|Control group: 1. block - saline|Control group: 1. block saline - 2. block ropivacaine
16121234|NCT02001649|Genetic|SNP Genotyping|Individuals were genotyped at a total 96 SNP from 15 candidate gene
16121235|NCT02001649|Genetic|SNP genotyping|
16121236|NCT02001636|Drug|Resource Instant Protein 88|Protein product: Resource Instant Protein 88, Nestlé Health Nutrition; postoperative intake of 30 - 35 g powder per day over 6 months.
16121237|NCT02001636|Drug|Resource Maltodextrin|Placebo product (Resource Maltodextrin, Nestlé Health Nutrition). Postoperative intake of 30 - 35 g powder per day over 6 months.
16121238|NCT02001623|Drug|Tisotumab Vedotin (HuMax-TF-ADC)|
16121239|NCT02001610|Dietary Supplement|Acidophilus pearls|"Acidophilus pearls are encapsulated using patented process
~Subjects take one capsule (containing at least 1 x 10^9 colony forming units) every morning for 12 days"
16121331|NCT02000856|Dietary Supplement|Beetroot juice|
16122337|NCT01993186|Drug|Placebo|oral liquid
16121240|NCT02001610|Dietary Supplement|Hard shell gelatin capsules|"Hard-shelled gelatin capsule with same microbial formulation as pearl supplement
~Subjects consume one capsule (containing at least 1 x 10^9 colony forming units) every morning for 12 days"
16121241|NCT02001584|Drug|Baclofen|
16121242|NCT02001584|Drug|Memantine|
16121243|NCT02001584|Drug|Placebo|
16121244|NCT02001571|Drug|Abiraterone acetate|On the morning of Day 1, each participant was given four 250 mg tablets of abiraterone acetate with 240 mL of room temperature tap water. Dosing followed at least a 10-hour fast from food (not including water).
16121245|NCT02001558|Drug|Microcyn|Microcyn is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with Microcyn twice daily for the earlier of total wound closure or Week 24
16121246|NCT02001558|Other|Sterile saline|Sterile saline is liberally sprayed on wound and permitted to remain on wound which will then be dressed with gauze that is moistened with sterile saline twice daily for the earlier of total wound closure or Week 24
16121247|NCT02001519|Drug|AC4-CDDP4|4 cycles of Adriamycin 60 mg/m2 and Cyclophosphamide 600 mg/m2 every 3 weeks 4 cycles of cisplatin 75 mg/m2 every 3 weeks
16121248|NCT02001506|Drug|FEC3-D3|"Fluorouracil 500 mg/m2, every 3 weeks Epirubicin 100 mg/m2, every 3 weeks Cyclophosphamide 500, every 3 weeks
~Docetaxel 75 mg/m2, every 3 weeks"
16121249|NCT02001480|Device|12 lead Holter|12 lead Holter measurements will be performed for 7 days
16121250|NCT02001480|Device|CGM Continuous Glucose Monitoring|CGM will be performed continously for 7 days
16121251|NCT02001467|Other|Simulation-based training|
16121252|NCT02001428|Drug|dihydroartemisinin-piperaquine|Participating infants with uncomplicated malaria will be treated with a three day course (1 dose/day) of DHP (containing 40 mg dihydroartemisinin and 320 mg piperaquine) administered as a total dose over three days of 6mg/kg of dihydroartemisinin and 57 mg/kg of piperaquine.
16121253|NCT02001415|Other|Spectacles|Normal spectacle lenses were used to correct myopia as the control group.
16121254|NCT02001415|Other|Myovision|Myovision is a kind of specially designed spectacle glasses that could control the peripheral refraction of myopia patients. It is commercially available.
16121255|NCT02001415|Other|Orthokeratology|Orthokeratology lenses.
16121256|NCT02001389|Drug|EVP-6308|Arms 1, 2, 3, 4
16121257|NCT02001376|Other|Intensive exercise|The intensive exercise group will receive moderate aerobic exercise and strengthening exercise three times a week for three months.
16121258|NCT02001376|Other|Home exercise|The home-based exercise group will receive exercise instruction biweekly for three months
16121259|NCT02001376|Other|Control group live as usual|Control group means no any intervention for them. The control group who with metabolic syndrome risk factors just live as usual.
16121260|NCT02001363|Drug|liraglutide (Novo Nordisk, Bagsværd, Denmark)|once-daily subcutaneous liraglutide 0.6 mg for 2 days, then gradually increase the dosage, once-daily subcutaneous liraglutide 1.2 mg for 2 days ,once-daily subcutaneous liraglutide 1.8 mg for 3 days
16121261|NCT02001363|Drug|liraglutide placebo (Novo Nordisk)|once-daily subcutaneous liraglutide placebo 0.6 mg for 2 days, then gradually increase the dosage, once-daily subcutaneous liraglutide placebo 1.2 mg for 2 days ,once-daily subcutaneous liraglutide placebo 1.8 mg for 3 days
16121262|NCT02001350|Other|Ultrasonography|
16121263|NCT02001337|Other|medical chart review|baseline, quarterly follow-up for 24 months
16121264|NCT02001337|Other|survey administration|baseline
16121265|NCT02001337|Other|Specimen collection|baseline
16121266|NCT02001324|Other|Web-based data collection|
16121267|NCT02001324|Other|Paper-based data collection|
16121268|NCT02001311|Drug|Chlorhexidine gluconate|
16121269|NCT02001298|Drug|remifentanil|
16121270|NCT02001298|Drug|nitroprusside|
16121271|NCT02001285|Drug|Remifentanil|During intubation, remifentanil will be infused to prevent change arterial blood pressure and heart rate.
16121272|NCT02001272|Drug|Paclitaxel + Carboplatin every 3 weeks|Patients will receive a premedication of 130mg prednisolone the day before (22 pm) and the morning (7 am). A pretreatment using corticosteroids, antihistamines and H2 antagonists and setrons in accordance with local standards of care will be administered 30 minutes before Paclitaxel administration. At H0, Paclitaxel is administered at 175mg/m² in 3 hours then Carboplatin is administered at AUC 5mg/mL/min.
16121273|NCT02001272|Drug|Carboplatin monotherapy every 3 weeks|A pretreatment using setrons in accordance with local standards of care will be administered 30 minutes before Carboplatin at AUC 5 to 6mg/mL/min in 1 hour.
16121274|NCT02001272|Drug|Weekly Paclitaxel and Carboplatin|A pretreatment using corticosteroids, antihistamines and H2 antagonists and setrons in accordance with local standards of care will be administered 30 minutes before Paclitaxel 60mg/m² in 1 hour followed by Carboplatin at AUC 2mg/mL/min in 1 hour.
16121275|NCT02001259|Drug|epidural triamsinolone|add drugs into catheter at 48 hr after surgery
16121276|NCT02001259|Drug|epidural lidocaine|add into catheter at 48 hr after surgery
16121277|NCT02001246|Behavioral|Real Deal program for Anger Management|Real Deal is an eight week program with sessions one day per week. Each session is approximately 2 hr long.
16121278|NCT02001246|Behavioral|Mind-body Bridging (MBB) program|MBB is an eight week program with sessions one day per week. Each session is approximately 2 hr long.
16121279|NCT02001233|Biological|EV71 vaccine|inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
16121280|NCT02001220|Procedure|Once daily screening|"In the 'once daily screening arm', RTs will screen invasively ventilated patients between approximately 06:00 - 08:00 hours daily.
~The initial SBT will be 30-120 minutes in duration and may be conducted with any one of the following techniques: T-piece, CPAP < to 5 cm H2 O or PS < 8 cm H2 O with PEEP < 5 - 10 cm H2O. Higher levels of PEEP (8-10 cm H2O) will be permitted (and recorded) to allow for clinician discretion in conducting SBTs in specific patients (e.g., obese, chronic obstructive pulmonary disease) and use of different humidification strategies. Each centre will choose one technique to be used for all patients enrolled at their centre."
16121332|NCT02000843|Procedure|tympanoplasty -- conchal cavum approach|Incision is made inside the ear canal. It is extended into the conchal cavum. The incision allows a direct approach to the eardrum, and also allow easy harvesting of the perichondrium to be used as graft material.
16121333|NCT02000830|Drug|Stannsoporfin|Stannsoporfin administered by intramuscular (IM) injection
16121281|NCT02001220|Procedure|At least twice daily screening|In the 'at least twice daily' screening arm patients will be screened at a minimum between approximately 6:00-8:00 hours and 13:00-15:00 hours daily. Initial SBT will be conducted in the same manner as once daily screening arm. Subsequent SBTs will be 30-120 minutes in duration and may be conducted with any one of the following techniques: T-piece, CPAP < to 5 cm H2 O or PS < 8 cm H2 O with PEEP < 5 - 10 cm H2O. Higher levels of PEEP (8-10 cm H2O). Higher levels of PEEP (8-10 cm H2O) will be permitted (and recorded) to allow for clinician discretion in conducting SBTs in specific patients (e.g., obese, chronic obstructive pulmonary disease) and use of different humidification strategies. Each centre will be asked to choose one technique to be used for all patients enrolled at their centre.
16121282|NCT02001207|Other|Salivary cortisol test|
16121283|NCT02001194|Behavioral|Individual Incentives|
16121284|NCT02001194|Behavioral|Team Incentives|
16121285|NCT02001194|Behavioral|Individual plus Team Incentives|
16121286|NCT02001181|Drug|Tofacitinib ointment 20mg/g|Tofacitinib ointment 20mg/g twice daily (BID) for 4 weeks
16121287|NCT02001181|Drug|Placebo ointment (Vehicle)|Placebo ointment (vehicle) twice daily (BID) for 4 weeks
16121288|NCT02001168|Drug|Pemetrexed|Pemetrexed 500 mg/m2, d1, 21 d as a cycle.
16121289|NCT02001168|Drug|Docetaxel|Docetaxel 60mg/m2 d1＋Cis-platinum 60mg/m2, d1, 21 d as a cycle.
16121290|NCT02001168|Drug|rh-Endostatin|rh-Endostatin 7.5mg/m2 d1-14; 21 d as a cycle.
16121291|NCT02001168|Drug|Cis-platinum|Cis-platinum 60mg/m2, d1, 21 d as a cycle.
16121292|NCT02001155|Procedure|Water Drinking Test|The Water Drinking test has been identified as a reliable and safe tool to predict maximum intraocular pressure values during a diurnal tension curve and to assess the efficacy of surgical interventions. Participants are asked to drink 10 ml/kg water (or approximately 0.33 ounces of water for every 2.2 pounds of weight or about 2.5 cups for a 150 lb. individual) over 15 minutes. Intraocular pressure is assessed every 15 minutes for one hour.
16121293|NCT02001142|Other|Exercise|single session of exercise
16121294|NCT02001129|Behavioral|Automated Telephone System|Participants receive automated reminder phone calls.
16121295|NCT02001129|Behavioral|Personalized Telephone Call|Participants receive reminder phone calls by study staff.
16121296|NCT02001129|Behavioral|Usual Care|Participants receive a standard reminder letter in the mail.
16121297|NCT02001116|Other|Quality Improvement intervention|"Training for local trainers and medical staff on the National Adaptation of the WHO guidelines Pocket Book of Hospital Care for Children.
~Regular supporting supervision and monitoring at hospital level aimed at a sustainable improvement of the quality of the paediatric hospital care"
16121298|NCT02001103|Drug|Memantine|"Pills of memantine, including 5 or 10 mg, all prepared in the same capsules as used in the placebo arm.
~The Memantine 10 mg intervention arm will take 1 capsule of memantine and 1 capsule of placebo going into week 3."
16121299|NCT02001103|Drug|Placebo|Capsules with starch inside manufactured using the same capsules as used in the other 2 arms.
16121300|NCT02001077|Behavioral|Cognitive Behavioral Therapy for Insomnia (CBT-I)|
16121301|NCT02001077|Behavioral|Cognitive Behavioral Therapy for Pain (CBT-P)|
16121302|NCT02001064|Behavioral|Care4Today v2.0 mobile application + electronic monitoring of adherence|Care4Today mobile application will send automated medication alert messages to HIV-infected persons. The alert messages are customizable and automated, and real-time results are viewable within the application. The Care4Today intervention is designed to improve adherence to ART medications among HIV-infected persons who experience adherence difficulties over standard of care.
16121303|NCT02001051|Procedure|Adrenalectomy|Surgery to remove tumor when enrolled in the protocol.
16121304|NCT02001051|Other|Observation|Observation for 6 months prior to surgery
16121305|NCT02001038|Other|Survey|
16121306|NCT02001025|Device|Absorb scaffold|
16121307|NCT02001025|Device|Xience stent|
16121308|NCT02001012|Drug|Artemether-lumefantrine combination|
16121309|NCT02001012|Drug|Chloroquine|
16121310|NCT02000999|Other|brushing of bile duct strictures for cytology|
16121311|NCT02000986|Behavioral|Specimen Collection/Risk Factor Assessment -> Diet/Exercise -> Chemotherapy|Participants will be taught by a registered dietician about energy balance and how body weight relates to energy intake and expenditure, although specific calorie prescriptions will not be given. An exercise physiologist will create a personalized exercise plan and prescription which is tailored to his / her needs and current level of activity and fitness
16121312|NCT02000973|Drug|Lidocaine|General anesthesia combined with thoracic epidural 1% lidocaine
16121313|NCT02000973|Drug|Bupivacaine|General anesthesia combined with thoracic epidural 0.25% bupivacaine
16121314|NCT02000973|Drug|Ropivacaine|General anesthesia combined with thoracic epidural 0.3% ropivacaine
16121315|NCT02000973|Drug|Normal Saline|General anesthesia combined with thoracic epidural 0.9% normal saline
16121316|NCT02000960|Drug|Triheptanoin|Triheptanoin (C7 oil) is a triglyceride of the anaplerotic odd-chain fatty acid heptonate.
16121317|NCT02000947|Drug|MEDI4736|MEDI4736 is an anti-PD-L1 monoclonal antibody (MAb).
16121318|NCT02000947|Drug|Tremelimumab|Tremelimumab is an anti-CTLA4 monoclonal antibody (mAb).
16121319|NCT02000947|Drug|tremelimumab|Tremelimumab is an anti-CTLA4 monoclonal antibody (mAb).
16121320|NCT02000934|Drug|TAK-659|TAK-659 tablet
16121321|NCT02000921|Other|VLNC cigarettes|Modified risk tobacco product
16121322|NCT02000921|Other|Combusted Products|Options for combusted tobacco products include cigars, cigarillos, and little cigars, .
16121323|NCT02000921|Other|Non-combusted products|Options for non-combusted tobacco products include smokeless tobacco, novel snus products, e-cigarettes and medicinal nicotine.
16121324|NCT02000921|Other|CN cigarettes|Experimental cigarettes with conventional nicotine content.
16121325|NCT02000908|Device|photobiomodulation|The photobiomodulation delivered by Realief Therapy involves amplitude wavelength light delivered by a class IV therapeutic laser.
16121326|NCT02000908|Other|Sham treatment|All patients in sham treatment arm cross over to laser therapy followed by physiotherapy
16121327|NCT02000908|Other|Physiotherapy|Chiropractic massage and lymphedema treatment
16121328|NCT02000882|Drug|BKM120|
16121329|NCT02000882|Drug|capecitabine|
16121330|NCT02000882|Drug|Trastuzumab|
16121335|NCT02000817|Biological|Otelixizumab|Otelixizumab is available at unit dose strength of 5 milligram/mL provided as 1 mL solution per vial to be diluted to 0.1 mg/mL in 0.9% sodium chloride. The 0.1 mg/mL solution is to be administered by intravenous infusion using a syringe pump and an in-line 0.2 micron filter by study personnel following specified regimens
16121336|NCT02000817|Biological|Placebo|Placebo is available 0.9% w/v sodium chloride
16121337|NCT02000804|Drug|darapladib 160mg|drug
16121338|NCT02000791|Other|Comparison of fibreoptic view|
16121339|NCT02000778|Drug|EC17|
16121340|NCT02000765|Drug|GSK2140944 for Injection|GSK2140944 (1 gram) for Injection will be supplied as powder for injection containing [14C] GSK2140944. Non sterile powder is to be dissolved aseptically in sterile water for injection to a concentration of 4 mg/mL free base equivalent. IV solution is prepared by sterile filtration. 250 mL of IV solution, equivalent to 1000 mg GSK2140944, is then administered intravenously.
16121341|NCT02000765|Drug|GSK2140944 Capsule|GSK2140944 Capsule (2 gram) will be supplied as powder in capsule containing [14C] GSK2140944. Powder is to be filled in empty capsule to achieve 200-400 mg strength per capsules as free base equivalent. Sufficient capsules are administered to provide the required total dose of 2 gram as free base.
16121342|NCT02000752|Device|Acupuncture|
16121343|NCT02000752|Device|Sham acupuncture|Sham point acupuncture
16121344|NCT02000739|Genetic|Genetically Informed Therapy|If there is a genetic mutation that can be identified with current DNA sequencing and a drug has been developed for this mutation, participants may be able to receive that drug. If there is more than one drug available, the participant and his/her oncologist will decide which is the best one for the participant.
16121345|NCT02000726|Drug|Placebo|
16121346|NCT02000726|Drug|Citalopram|
16121347|NCT02000726|Drug|Fast acting antidepressant-like treatment. administered i.v. during the fMRI scanning session|Fast acting antidepressant-like treatment administered intravenously for 35 min. during the fMRI scanning session.
16121348|NCT02000713|Other|MRI|Subjects will have magnetic resonance imaging(MRI)scans of the cervical spine(neck). This involves lying on a table and sliding into a scanner consisting of a large magnet. This will take approximately one hour to complete. All subjects will be instructed to remove all jewelry and other metal-containing objects for the scan. During the MRI scan loud noises may be heard. Subjects may have a soft brace for the neck for positioning purposes.
16121349|NCT02000713|Other|Clinical Exam|Brief neurological exam will be performed.
16121350|NCT02000700|Drug|Canagliflozin 100 mg|One 100-mg tablet of canagliflozin orally administered daily for 14 days.
16121351|NCT02000700|Drug|Canagliflozin 50 mg|One 50-mg tablet of canagliflozin orally administered daily for 14 days.
16121352|NCT02000700|Drug|Canagliflozin 300 mg|One 300-mg tablet of canagliflozin orally administered daily for 14 days.
16121353|NCT02000700|Drug|Placebo|One matching placebo tablet orally administered at baseline phase.
16121354|NCT02000674|Drug|Succinylcholine : 1mg/kg|
16121355|NCT02000674|Drug|Rocuronium : 1.2 mg/kg|
16121356|NCT02000661|Device|Fractional Flow Reserve (FFR)|Fractional Flow Reserve (FFR) performed per guidelines to guide PCI
16121357|NCT02000635|Other|Quantitative PCR performed at H0 , H24, H48 , H72, 7th day and 14th day|
16121358|NCT02000622|Drug|Olaparib|Patients will be administered olaparib orally twice daily (bid) at 300 mg. Two (2) x 150 mg olaparib tablets should be taken at the same times each morning and evening of each day, approximately 12 hours apart with approximately 240 mL of water.
16121359|NCT02000622|Drug|Physician's choice chemotherapy|"Investigators will declare one of the following regimens:
~Capecitabine 2500 mg/m2 po daily (divided in 2 doses) x 14 days, repeat every 21 days
~Vinorelbine 30 mg/m2 IV Day 1 and Day 8, repeat every 21 days
~Eribulin 1.4 mg/m2 IV Day 1 and Day 8, repeat every 21 days"
16121365|NCT02000596|Drug|Trastuzumab plus Pertuzumab|
16121366|NCT02000596|Drug|Hormonal Therapy with Anastrozole and Fulvestrant|Anastrozole 1mg by mouth daily FULVESTRANT 500mg i.m. D1, D15, D28 then every 28-30 days
16121367|NCT02000596|Drug|Chemotherapy with Eribulin|
16121368|NCT02000583|Other|Aerobic Exercise|Aerobic group participants will engage in 150 minutes of aerobic exercise over 4-5 days per week for 52 weeks
16121369|NCT02000583|Other|Standard of Care|Control group participants will be provided educational materials on starting an exercise program, but will receive no formal support for their exercise program.
16121370|NCT02000570|Procedure|Sitting position (neurosurgery)|
16121371|NCT02000544|Device|Modular Cardiopulmonary Bypass Circuit|Open heart surgery with a novel hybrid modular extracorporeal circulation circuit which is a closed cardiopulmonary bypass circuit with enhanced safety as it can be instantly converted to an open circuit.
16121372|NCT02000531|Drug|Erlotinib|150 mg oral dose of erlotinib given once daily
16121373|NCT02000531|Drug|Chemotherapy|Cisplatin (75 mg/m^2 intravenously [IV]) on Day 1 and gemcitabine (1250 mg/m^2 IV) on Days 1 and 8 of 3-week chemotherapy cycles until disease progression, unacceptable toxicity or up to 4 cycles (whichever comes first)
16121374|NCT02000518|Radiation|external beam radiotherapy|
16121375|NCT02000505|Device|PocketCPR|5 minutes chest-compression-only CPR, using Zoll PocketCPR
16121376|NCT02000505|Device|Metronome|5 minutes chest-compression-only CPR, using a metronome
16121377|NCT02000505|Device|110bpm Song|5 minutes chest-compression-only CPR, using a song with 110bpm for support
16121378|NCT02000492|Behavioral|Football|
16121379|NCT02000492|Behavioral|Running|
16121380|NCT02000492|Behavioral|Circuit training|
16121381|NCT02000479|Other|training|
16121382|NCT02000466|Other|Data collection|Initial and follow-up data will be collected using questionnaires
16121383|NCT02000453|Drug|GSK2586184 400mg|White film coated round biconvex GSK2586184 200 mg tablets, administered 2 X twice daily. Tablet containing GSK2586184A, with the following excipients: microcrystalline cellulose, lactose, hypromellose, croscarmellose sodium, magnesium stearate and titanium dioxide.
16121599|NCT01998919|Drug|gemcitabine|1250 mg/m2 iv Days 1 and 8 of each 4-week cycle, 6 cycles
16121384|NCT02000440|Drug|Losmapimod|Losmapimod (micronized GW856553X) will be supplied as a film coated white, 7 mm round, biconvex, plain faced, tablet. Oral doses of losmapimod, 7.5 mg (1 tablet) or 15 mg (2 tablets), will be taken twice daily (BID) with food and swallowed whole (not chewed or crushed)
16121385|NCT02000427|Drug|Blinatumomab|Blinatumomab is administered as a continuous intravenous infusion (CIV). A single cycle of blinatumomab treatment is 6 weeks in duration, which includes 4 weeks of blinatumomab followed by a 2-week treatment-free interval.
16121386|NCT02000414|Drug|intraperitoneal daptomycin|intraperitoneal daptomycin administartion and study of daptomycin kinetics
16121387|NCT02000401|Drug|Ketorolac Tromethamine|
16121388|NCT02000388|Drug|Ketorolac Tromethamine|
16121389|NCT02000388|Other|Standard of Care|
16121390|NCT02000375|Drug|DHEA|DHEA: Daily oral administration of DHEA(Dehydroepiandrosterone) at the dosage of 100 mg/die in combination with a daily oral administration of anastrozole at dosage of 1 mg/die or letrozole at the dosage of 2.5 mg/die or exemestane at the dosage of 25 mg/die without interruption.
16121391|NCT02000362|Biological|Stem cells|
16121392|NCT02000349|Other|PGD|PGD using Next generation sequencing
16121393|NCT02000336|Drug|Prednisolone|To compare two standard p.o. GC starting dosages and the non-use of GCs in the treatment of patients with early active RA on the background of the established 'anchor' therapy with methotrexate (MTX).
16121394|NCT02000336|Drug|Placebo|
16121395|NCT02000323|Other|early enteral nutrition|"Naso-gastro-jejunal tube will be set up by X-ray within 24 hours of admission.
~The distal end of the feeding tube would be placed at the remote end of Treitz ligament, and verified by X-ray.
~• After catharsis, Standard enteral nutrition liquid regimen will be used step by step.
~Patients are targeted to receive calories for 25 kcal/kg/day.
~nutrition form: short peptide ,1 kcal/ml,target 200k kcal/day"
16121396|NCT02000323|Other|modified early enteral nutrition|"Naso-gastro-jejunal tube will be set up by X-ray within 24 hours of admission.
~The distal end of the feeding tube would be placed at the remote end of Treitz ligament, and verified by X-ray.
~After catharsis, Only Normal Saline were given through nasojejunal tube until 2 or more followed requirements were meted (mean arterial pressure≥65mmHg; oxygenation index≥ 300;APCHEII≤8; intra-abdominal pressure <20mmHg).Then Standard enteral nutrition liquid regimen (Peptisorb Liquid) will be used step by step.
~Patients are targeted to receive calories for 25 kcal/kg/day."
16121397|NCT02000297|Procedure|Allogenic bone graft|Patients in this arm is treated with allogenic bone graft to fill the bone defect created with medial open wedge high tibial osteotomy
16121398|NCT02000297|Procedure|Synthetic bone substitute (geneX®)|Patients in this arm is treated with synthetic bone substitute (geneX®) to fill the bone defect created with medial open wedge high tibial osteotomy
16121399|NCT02000271|Procedure|Vaginal packing|
16121400|NCT02000271|Procedure|No vaginal packing|
16121401|NCT02000258|Procedure|Double-bundle ACL reconstruction|
16121402|NCT02000258|Device|Magnetic resonance imaging (MRI)|MRI sequences were as follows: sagittal T1-weighted, proton density (PD)-weighted and T2-weighted fast spin echo (FSE) images with 4 mm slice and 1 mm gap, coronal T1-weighted and fat-saturated T2-weighted FSE images with 4 mm slice and 1 mm gap, axial fat saturated PD FSE images with 4 mm slice and 1 mm gap and oblique sagittal and oblique coronal T1 FSE images along AM graft plane with 3 mm slice and 0.3 mm gap.
16121403|NCT02000245|Behavioral|verbal expression for compassion|The doctor going to perform bronchoscopy tells a short sentence to a patient. (Hello, I'm Dr.OO. During this test, I will keep an eye on you. Don't worry)
16121404|NCT02000245|Behavioral|touch|The doctor going to perform bronchoscopy puts a hand on the patient's shoulder
16121405|NCT02000219|Biological|Oxalobacter formigenes|The dose will be (not less than) NLT ≥1E+09 colony forming units (CFU) twice daily. The dose (an enteric-coated capsule) will be administered orally with breakfast and dinner.
16121406|NCT02000206|Drug|Propofol|
16121407|NCT02000206|Drug|Ketamine|
16121408|NCT02000206|Drug|Alfentanil|
16121409|NCT02000193|Drug|fulvestrant|"Eligible patients will receive fulvestrant 500 mg intramuscular injection on day 1, 15, and 29， then every 28 days.
~The treatment will continue until disease progression or intolerable AE."
16121410|NCT02000180|Behavioral|Progressive Group|
16121411|NCT02000154|Drug|SyB L-1101|SyB L-1101 (rigosertib sodium) will be administered intravenously 72 continuous hours (3 days), followed by 25-day observation period. The treatment period of 28 days (3 days of administration + 25 days of observation) constitutes 1 cycle. The dose at cycle 8 in the study 2011005 will be the dose (if needed, the dose can be reduced) at the first cycle in this study (cycle 9). From cycle 10 on, the dose of SyB L-1101 will be reduced, delayed, or discontinued according to adverse events and results of observation at the previous cycle.
16121412|NCT02000141|Procedure|Endoscopic Mucosal Resection|
16121413|NCT02000128|Device|bioimpedance monitoring|To assess the body composition using Multi-frequency bioelectrical impedance analysis
16121414|NCT02000128|Other|clinical monitoring|clinical symptom and examination,such as edema, body weight, blood pressure, cardial function
16121415|NCT02000115|Device|Portico transcatheter aortic valve|St. Jude Medical transcatheter Portico aortic valve
16121416|NCT02000115|Device|Commercially available transcatheter aortic valve|Commercially available transcatheter aortic valve
16121417|NCT02000102|Drug|Intravitreal Injection of Aflibercept|
16121418|NCT02000089|Drug|Human synthetic secretin|I.V. bolus of 0.2 mcg/kg secretin given to induce pancreas juice secretion. This intervention offered for all cohorts
16121419|NCT02000076|Behavioral|Partial sleep deprivation allowing 3 h sleep at night|Participants sleep at home while monitored with ambulatory polysomnography. For the full sleep condition, they are instructed to go to bed and to get up at the usual times that they would normally do that. For the sleep deprivation condition, they are instructed to go to bed 3 hours before the time when they would usually get up, and then to get up at that time.
16121420|NCT02000076|Behavioral|Full sleep|Participants sleep at home while monitored with ambulatory polysomnography. For the full sleep condition, they are instructed to go to bed and to get up at the usual times that they would normally do that. For the sleep deprivation condition, they are instructed to go to bed 3 hours before the time when they would usually get up, and then to get up at that time.
16121421|NCT02000050|Drug|FOLFOX4|FOLFOX4
16121422|NCT02000050|Radiation|Tomotherapy|Tomotherapy
16122482|NCT01992107|Biological|TIV1c|Licensed Influenza Vaccine
16121424|NCT02000037|Device|IR Reflexotherapy|"18 IR reflexotherapy sessions :
~Once a week for 12 weeks at the beginning of the study
~Once a week for 3 weeks, 9 months after the beginning of the study
~Once a week for 3 weeks, 15 months after the beginning of the study"
16121425|NCT02000037|Behavioral|Dietary care|Dietary consultation 1, 2, 3, 6, 9, 12, 15 and 18 months after the beginning of the study
16121426|NCT02000024|Behavioral|Weight Watchers|"The standard Weight Watchers program will serve as the base curriculum. Persons with increased risk for developing type 2 diabetes will be exposed to an initial orientation session designed to frame the rationale for participation in the program and to encourage attendance to a core series of sessions. This orientation session will reinforce the pre-diabetes status of participants and present the rationale for lifestyle modification as a means to reduce diabetes risk. In addition, this session will highlight the recommended sessions and topics that are needed to help reduce risk."
16121427|NCT02000024|Behavioral|National Diabetes Education Program|
16121428|NCT02000011|Other|comprehensive geriatric assessment (CGA)|
16121429|NCT02000011|Other|Geriatric intervention plan (GIP)|
16121430|NCT01999998|Radiation|Radiotherapy|
16121431|NCT01999985|Drug|Dasatinib - 1A|1A: Begins Day 8. Level 1 - 100 mg, Level 2 - 100 mg, Level 3 - 140 mg.
16121432|NCT01999985|Drug|Afatinib - 1A|1A: Begins Day 1. Level 1 - 30 mg, Level 2 - 40 mg, Level 3 - 40 mg.
16121433|NCT01999985|Drug|Dasatinib - 1B|In Phase 1B, a mutationally selected 20 participants (total) will be treated at the recommended dose to confirm tolerability and evaluate for early response signal.
16121434|NCT01999985|Drug|Afatinib - 1B|In Phase 1B, a mutationally selected 20 participants (total) will be treated at the recommended dose to confirm tolerability and evaluate for early response signal.
16121435|NCT01999972|Drug|axitinib|Axitinib: tablets, dosage range 2 - 5 mg, given orally twice daily on a continuous dosing schedule in 28 days cycles.
16121436|NCT01999972|Drug|crizotinib|Crizotinib: capsules, dosage range 200-250 mg, given orally twice daily or every day on a continuous dosing schedule in 28 days cycle.
16121437|NCT01999972|Drug|axitinib|Axitinib: tablets, dosage be defined based on Arm 1 results, given orally twice daily on a continuous dosing schedule in 28 days cycles.
16121438|NCT01999972|Drug|crizotinib|Crizotinib: capsules, dosage be defined based on Arm 1 results, given orally twice daily or every day on a continuous dosing schedule in 28 days cycle.
16121439|NCT01999972|Drug|axitinib|Axitinib: tablets, dosage be defined based on Arm 1 results, given orally twice daily on a continuous dosing schedule in 28 days cycles.
16121440|NCT01999972|Drug|crizotinib|Crizotinib: capsules, dosage be defined based on Arm 1 results, given orally twice daily or every day on a continuous dosing schedule in 28 days cycle.
16121441|NCT01999959|Procedure|Pertubation|a lavage procedure of the intrauterine cavity and bilateral fallopian tubes
16121442|NCT01999946|Drug|Extended-Release Naltrexone|Extended-Release Naltrexone (Vivitrol®), 380mg administered 1x/month by intramuscular injection.
16121443|NCT01999933|Radiation|Radiation|Arm1, Arm2 and Arm3 patients should received the whole pelvic radiation.
16121444|NCT01999933|Drug|cisplatin（DDP） weekly|concurrent chemotherapy with cisplatin（DDP） weekly(40mg/m2),begin with radiation
16121445|NCT01999933|Drug|docetaxel plus cisplatin|concurrent docetaxel plus cisplatin tri-weekly (75mg/m2),2 cycles, begin with radiation
16121446|NCT01999933|Drug|docetaxel plus cisplatin|adjuvant chemotherapy with docetaxel plus cisplatin tri-weekly (75mg/m2), 4 cycles after radiation
16121447|NCT01999920|Drug|Vilazodone|10mg to 40mg per day for 12 weeks
16121448|NCT01999920|Drug|Placebo|One to two pills per day for 12 weeks
16121449|NCT01999907|Dietary Supplement|Vitamin D|100,000IU cholecalciferol given in a 2ml dose by mouth at baseline.
16121450|NCT01999907|Dietary Supplement|daily vitamin D supplement|Each group receives a daily vitamin D supplement for 6 months, providing 400IU per day.
16121451|NCT01999907|Other|Placebo|placebo given in a 2ml dose by mouth at baseline.
16121452|NCT01999894|Drug|Memantine HCl|Memantine extended release 3- and 6-mg capsules; dose ranging 3 - 18 mg/day; weight based dosing in 4 weight groups; oral administration. Dosing is once daily for 48 weeks.
16121453|NCT01999881|Behavioral|exercise intervention|Receive aerobic and exercise intervention
16121454|NCT01999881|Procedure|standard follow-up care|Receive usual care
16121455|NCT01999881|Procedure|quality-of-life assessment|Ancillary studies
16121456|NCT01999881|Other|laboratory biomarker analysis|Correlative studies
16121457|NCT01999868|Biological|Ustekinumab|"Ustekinumab interferes with the actions of proteins, interleukin 12 (IL12) and interleukin 23 (IL23), which reduces inflammation (swelling) in the skin. Stelara™ is the trade name for ustekinumab and is approved by the U.S. Food and Drug Administration (FDA) to treat psoriasis.
~Dose:
~Participants who weigh <= 100 kg at study entry will receive 45 mg of ustekinumab.
~Participants who weigh > 100 kg at study entry will receive 90 mg of ustekinumab."
16121458|NCT01999868|Biological|Abatacept|"Abatacept (one form of the protein called CTLA4-Ig) interacts with the immune system, reducing the activity of T-cells and may prevent relapse. Orencia™ is the trade name for abatacept, and it is approved by the FDA to treat rheumatoid arthritis in adults.
~Dose:
~125 mg sub-cutaneous injection"
16121459|NCT01999868|Drug|UST Placebo|The abatacept treatment group will also receive subcutaneous placebo for ustekinumab (sterile normal saline) at week 16 and week 28, corresponding to the ustekinumab dosing regimen.
16121460|NCT01999868|Drug|ABA Placebo|The ustekinumab treatment group will also receive weekly subcutaneous injections of placebo for abatacept from week 12 to week 39, corresponding to the abatacept dosing regimen.
16121461|NCT01999855|Other|Phoniatric tests|
16121462|NCT01999842|Biological|Investigational H7N9 vaccine GSK3206641A|One dose of GSK3206641A H7N9 vaccine administered intramuscularly (IM) in the deltoid region of arm at Day 0 and the second dose of GSK3206641A H7N9 vaccine administered IM in the deltoid region of arm at Day 21
16121463|NCT01999842|Biological|Investigational H7N9 vaccine GSK3206640A|One dose of GSK3206640A H7N9 vaccine administered IM at the deltoid region of arm at Day 0 and the second dose of GSK3206640A H7N9 vaccine administered IM at the deltoid region of arm at Day 21
16121464|NCT01999842|Biological|Placebo|One dose of placebo administered IM at the deltoid region of arm at Day 0 and the second dose of placebo administered IM at the deltoid region of arm at Day 21
16121465|NCT01999829|Drug|citrate of caffeine|
16121467|NCT01999816|Behavioral|Lifestyle Redesign|Individualized program for lifestyle redesign aimed at decreasing the risk of medically serious pressure ulcers led by licensed occupational therapists trained in the implementation of the lifestyle redesign program
16121468|NCT01999803|Drug|sNN0029|
16121469|NCT01999803|Drug|Placebo|
16121470|NCT01999790|Procedure|blepharotomy|upper eyelid surgery by blepharotomy
16121471|NCT01999790|Procedure|posterior approach|upper eyelid surgery by posterior approach
16121472|NCT01999777|Drug|USL261|
16121473|NCT01999777|Drug|Placebo|
16121474|NCT01999764|Drug|QLT091001|QLT091001 administered orally at multiple time points.
16121475|NCT01999764|Other|Placebo|Placebo is administered orally at multiple time points.
16121476|NCT01999751|Device|MRI Scan|Clinically indicated MRI scan of patients with pacemaker or implantable cardioverter-defibrillator in situ.
16121477|NCT01999738|Drug|EC1456 and EC20|"EC1456 is small molecule drug conjugate of folic acid and tubulysin B hydrazide (TubBH) that specifically binds to the membrane-bound FR and gains entry into the cell via endocytosis.
~EC20 is Etarfolatide, a conjugate of folic acid and a tripeptide moiety that can efficiently chelate the radioisotope 99mTechnetium (99mTc). When etarfolatide is labeled with 99mTc, the product (99mTc-etarfolatide) is able to quantify FR expressing tissues with SPECT imaging."
16121478|NCT01999725|Drug|EDP-788|EDP-788 Capsules and matching placebo capsules. EDP-788 Liquid Suspension and matching placebo. All interventions are given as single doses
16121479|NCT01999725|Drug|Placebo|Matching placebo capsules or matching suspension
16121480|NCT01999712|Procedure|Echocardiography|Patients will undergo an echocardiogram at baseline (preoperative) and at 30 and 90 days after LVAD implantation
16121481|NCT01999699|Biological|HEPLISAV|
16121482|NCT01999686|Drug|DLBS3233|
16121483|NCT01999686|Drug|Metformin XR|
16121484|NCT01999686|Drug|Placebo metformin|Placebo metformin has the same ingredients with Metformin XR caplet, except that it does not contain the active substance (metformin).
16121485|NCT01999686|Drug|Placebo DLBS3233|Placebo DLBS3233 has the same ingredients with DLBS3233 capsule, except that it does not contain the active substance (DLBS3233).
16121486|NCT01999673|Biological|bavituximab|
16121487|NCT01999673|Drug|Docetaxel|
16121488|NCT01999673|Other|Placebo (for bavituximab)|
16121489|NCT01999660|Device|SpaceOAR™ implantation|
16121490|NCT01999647|Procedure|Intraneural Injection for Subgluteal Sciatic Nerve Block|"The injection will start as the needle penetrates the outermost discernible layer of the nerve (epineurium) under ultrasound guidance. The injection will be adjudicated as intraneural if nerve cross section expansion and a reduction in echogenicity are observed.
~Short-axis real-time ultrasound imaging will be used, with an in-plane needle approach."
16121491|NCT01999647|Procedure|Perineural Injection for Subgluteal Sciatic Nerve Block|"The injection will start as the needle indents the outermost discernible layer of the nerve (epineurium) under ultrasound guidance. The injection will be adjudicated as intraneural if the drug infiltrates the space between the epimysium of the surrounding muscles and the outer epineurium of the sciatic nerve.
~Short-axis real-time ultrasound imaging will be used, with an in-plane needle approach."
16121492|NCT01999647|Procedure|Femoral Nerve Block|Patients will receive an ultrasound-guided femoral nerve block using a short- or long-acting local anesthetic, as deemed indicated.
16121493|NCT01999647|Procedure|Patient-Controlled Postoperative Analgesia|Patients will receive a patient-controlled intravenous or perineural catheter-based analgesia, depending on their preference and the anesthesiologist's indication.
16121494|NCT01999647|Drug|Ropivacaine|Thirty milliliters of 0.75% (wt/vol) ropivacaine will be used for the sciatic nerve block.
16121495|NCT01999634|Device|cma microdialysis catheter placement|the microdialysis catheters are sold by CMA
16121496|NCT01999595|Device|Control TENS|Control TENS was the application of electrical stimulation via skin with no current
16121497|NCT01999595|Device|Sham TENS|"Sham TENS was the application of electrical stimulation via skin with no current on the participant, who was told TENS is at a turn-on level whether or not you feel it"
16121498|NCT01999595|Device|High frequency TENS with large pads|High frequency TENS was delivered on large electrodes
16121499|NCT01999595|Device|Low frequency TENS with large pads|Low frequency TENS was delivered on large electrodes
16121500|NCT01999595|Device|High frequency TENS with small pads|High frequency TENS was delivered on small electrodes
16121501|NCT01999595|Device|Low frequency TENS with small pads|Low frequency TENS was delivered on small electrodes
16121502|NCT01999582|Biological|Sotatercept|Sotatercept is dosed intravenously every 14 days. The dose a subject receives will depend on the randomization arm and the dose group.
16121503|NCT01999582|Biological|Sotatercept|Sotatercept is dosed subcutaneously every 14 days. The dose a subject receives will depend on the randomization arm and the dose group.
16121504|NCT01999569|Drug|Letrozole|Letrozole administered daily through the time of ovulation.
16121505|NCT01999543|Dietary Supplement|plant-based dietary supplement|
16121506|NCT01999543|Other|Placebo|
16121507|NCT01999530|Drug|Prazosin Hydrochloride|Gradual upward titration to 15mg/day for approximately three weeks.
16121508|NCT01999517|Drug|Intravenous Nitroglycerin|
16121509|NCT01999517|Drug|IV Fluids|
16121510|NCT01999504|Other|PAL-2|meal
16121511|NCT01999504|Other|TFH-1|Meal
16121512|NCT01999504|Other|Reference|Meal
16121513|NCT01999465|Device|Standard NMES device|"Blinded parents will follow the NMES parent instructions and place the NMES on the biceps muscle of their child for 30 minutes every day for three months.
~Rate(35 Hz)
~Width (300 us)
~Ch1 Ramp+ (2 seconds)
~On Time 1 (10 seconds)
~Ch1 Ramp - (2 seconds)"
16121514|NCT01999465|Device|Sham NMES device|"Blinded parents will follow the NMES parent instructions and place the NMES on the biceps muscle of their child for 30 minutes every day for three months.
~Rate(35 Hz)
~Width (48 us)
~Ch1 Ramp+ (0 seconds)
~On Time 1 (0 seconds)
~Ch1 Ramp - (0 seconds)"
16121515|NCT01999452|Behavioral|Paleolithic diet|
16121516|NCT01999452|Behavioral|Diabetes diet|
16121600|NCT01998919|Drug|cisplatin|75 mg/m2 iv Day 1 of each 4.wek cycle, 6 cycles; or carboplatin
16121601|NCT01998919|Drug|carboplatin|5 x AUC iv Day 1 of each 4.week cycle, 6 cycles; or cisplatin
16121517|NCT01999439|Procedure|Eosinophilic Esophagitis with Dysphagia|"An upper endoscopy with biopsy at the time of diagnosis(which is a standard procedure to diagnose eosinophilic esophagitis. This will be done with sedation or general anesthesia, also a standard procedure. At the time of the anesthesia a small amount of blood will be drawn to measure markers of inflammation and fibrosis. This procedure will take approximately 45 minutes to complete. This endoscopy with biopsy will be repeated in 6 months.
~Subjects will also complete a magnetic resonance imaging(MRI)scan with 2 weeks of the initial clinical endoscopy with biopsy, prior to the initiation of your medical treatment. This MRI will be repeated in 6 months. Each magnetic resonance imaging(MRI)scan will take approximately 2 hours to complete."
16121518|NCT01999439|Procedure|Eosinophilic Esophagitis with Dysphagia|Subjects will also complete a magnetic resonance imaging(MRI)scan with 2 weeks of the initial clinical endoscopy with biopsy, prior to the initiation of your medical treatment. This MRI will be repeated in 6 months. Each magnetic resonance imaging(MRI)scan will take approximately 2 hours to complete.
16121519|NCT01999426|Other|Airway clearance intervention|Both respiratory and non-respiratory on-call physiotherapists provide similar airway clearance treatments, the precise components and delivery of which will vary between physiotherapists
16121520|NCT01999413|Drug|OMEGAVEN|AML Study treatment induction phase
16121521|NCT01999413|Drug|Daunorubicin|AML Study treatment induction phase
16121522|NCT01999413|Drug|Cytarabine|AML Study treatment induction phase
16121523|NCT01999400|Drug|Pentasa 500 mg capsule x 2 with 240 mL water; single dose|
16121524|NCT01999400|Drug|Apriso 375 mg capsule x 3 with 240 mL water; single dose|
16121525|NCT01999400|Drug|Lialda 1200 mg tablet x 1 with 240 mL water; single dose|
16121526|NCT01999400|Drug|Delzicol 100 mg mesalamine x 1 with 245 mL water; single dose|
16121527|NCT01999387|Dietary Supplement|Allergenic food|
16121528|NCT01999361|Drug|Myfortic|treatment with myfortic
16121529|NCT01999348|Drug|Fixed Combination Bimatoprost and Timolol|Patients with POAG or OHT treated with GANFORT® UD (fixed combination bimatoprost and timolol) administered in accordance with physician standard practice for up to 12 weeks.
16121530|NCT01999335|Drug|Oprozomib|Extended release (ER) tablets administered orally
16121531|NCT01999335|Drug|Pomalidomide|Capsules for oral administration
16121532|NCT01999335|Drug|Dexamethasone|Tablets for oral administration
16121533|NCT01999322|Drug|Faster-acting insulin aspart|Administered subcutaneously (s.c., under the skin). Dose individually adjusted.
16121534|NCT01999322|Drug|insulin aspart|Administered subcutaneously (s.c., under the skin). Dose individually adjusted.
16121535|NCT01999309|Drug|Simvastatin|The lipid-lowering drug simvastatin is added to normal antipsychotic treatment. One 40 mg simvastatin tablet daily for the treatment period of one year.
16121536|NCT01999309|Drug|Placebo|Placebo is added to normal antipsychotic treatment. One identical looking placebo tablet daily for the treatment period of one year.
16121537|NCT01999296|Device|Use of Thunderbeat (TM) in laparoscopic surgery|
16121538|NCT01999283|Other|Yoga Group Exercise|Yoga poses and postures modified to diminish stress on the cervical region and improve flexibility. Breathing and mind-body focus to address stress-related discomfort. A general Hatha yoga style will be used with components from Ashtanga Yoga. Intensity and range of motion will be progressively increased as tolerated.
16121539|NCT01999283|Other|Pilates Group Mat Exercise|The Pilates mat exercises focus on both spinal muscle activation and stability, progressive endurance of the stabilizing muscles with arm and leg challenges and dynamic mobility. The exercises are progressed from more supported to anti-gravity position, slow increases in arm weights and flexibility.
16121540|NCT01999270|Drug|Irinotecan|"Irinotecan IV over 90 minutes on Days 1, 15, and 29 of each cycle (except Cycle 1, when it will be started on Day 29)
~Note: Irinotecan can be removed from the treatment plan at the discretion of the healthcare provider."
16121541|NCT01999270|Drug|Bevacizumab|Bevacizumab will be given intravenously AFTER the irinotecan infusion is complete on Days 1, 15, and 29 of each cycle. The first dose will be given over 90 minutes, but doses after that may be given over 30-60 minutes.
16121542|NCT01999270|Device|FDOPA-PET/MRI imaging|FDOPA-PET/MRI imaging Baseline (before beginning Cycle 1 treatment) Cycle 1, Day 29 (before receiving your treatment with bevacizumab) and end of treatment or time of relapse
16121543|NCT01999257|Other|Online pre-test genetic education tool|See Arm Descriptions above.
16121544|NCT01999244|Behavioral|Self-monitoring skills|
16121545|NCT01999244|Behavioral|Technology|
16121546|NCT01999244|Behavioral|Interventionist Contact|
16121547|NCT01999231|Biological|ESAT6-CFP10|32 healthy subjects who meet the standard of protocol are allocated four different groups according to dosages of ESAT6-CFP10 :1μg/ml ESAT6-CFP10、5μg/ml ESAT6-CFP10、10μg/ml ESAT6-CFP10、20μg/ml ESAT6-CFP10.Each dose group have six healthy subjects(three male and three female) , at the same time set up two people for substitute (one male and one female) . ESAT6-CFP10 administered intradermally by the mantoux injection technique. Each receives only one dosage in right or left arm .
16121548|NCT01999218|Drug|Ertugliflozin 5 mg|Ertugliflozin, 5 mg, oral, once daily, from Day 1 to Week 104
16121549|NCT01999218|Drug|Ertugliflozin 10 mg|Ertugliflozin, 10 mg, oral, once daily from Day 1 to Week 104.
16121550|NCT01999218|Drug|Glimerpiride|Glimepiride, oral tablets, initiated at 1 mg daily and titrated up to the maximum approved dose (8 mg daily based on the local country label) or maximum tolerated dose
16121551|NCT01999218|Drug|Placebo to Ertugliflozin|Matching placebo to ertugliflozin, 5 mg and/or 10 mg, oral, once daily, from Day 1 to Week 104
16121552|NCT01999218|Drug|Placebo to Glimepiride|Matching placebo to glimepiride, 1 mg or 2 mg, oral, once daily, from Day 1 to Week 104.
16121553|NCT01999218|Drug|Metformin|Participants are to remain on their stable doses of metformin (oral, >=1500 mg/day) while receiving blinded investigational product during the double-blind treatment period. Participants on metformin <1500 at screening are up-titrated to >= 1500 daily.
16121554|NCT01999218|Drug|Sitagliptin|Open label, oral, once daily, rescue medication as required.
16121555|NCT01999205|Behavioral|Physical activity promotion|A nominated team in each participating company develops a plan to promote physical activity and to reduce sedentary behavior of the employees.
16121556|NCT01999192|Drug|Tregalizumab|humanized anti-CD4 mAb
16121557|NCT01999192|Drug|Placebo|identical end formulation buffer
16121558|NCT01999179|Drug|Heparin, Low-Molecular-Weight, or direct oral anticoagulants|Cancer patients will be treated with enoxaparin 1 mg/kg subcutaneously every 12 hours for one month following catheter removal or alternate enoxaparin dose or interval based on anti-factor Xa testing obtained by the clinical team or either apixaban, rivaroxaban, dabigatran, edoxaban following a catheter related blood clot
16121559|NCT01999166|Radiation|radiography (X-ray)|
16121560|NCT01999166|Genetic|DNA sampling|
16121561|NCT01999153|Drug|20 mL topically used during alginate dressing NAROPEINE|20 mL topically used during alginate dressing
16121562|NCT01999153|Drug|20 mL topically used during alginate dressing NaCl|20 mL topically used during alginate dressing
16121563|NCT01999114|Drug|Buprenorphine transdermal patch|Buprenorphine patch applied transdermally
16121564|NCT01999114|Drug|Naltrexone tablet|Naltrexone tablet; 1 tablet taken orally every 12 hours
16121565|NCT01999114|Drug|Placebos (for TDS and for naltrexone and for moxifloxacin)|Matching placebos
16121566|NCT01999114|Drug|Moxifloxacin tablet|Moxifloxacin tablet; 1 tablet taken orally on Days 6, 13 and 17
16121567|NCT01999101|Drug|Px-104|28 days treatment
16121568|NCT01999088|Other|Functional Meet|During the I period, volunteers weekly consumed three 150g/serving Functional Meat (FM) products (cooked Ham and Turkey breast). It was firmly recommended that all other meats and meat derivatives had to be excluded from the diet.
16121569|NCT01999088|Other|Control Meat|During the C period, volunteers consumed identical amounts of meat products that did not include functional ingredients (Control Meat (CM)).
16121570|NCT01999075|Device|Lung Volume Recruitment (LVR)|LVR will be used twice per day
16121571|NCT01999075|Other|Conventional Treatment|This may include: a. Physiotherapy, consisting of percussion, active cycle of breathing and/or postural drainage; b. Nutritional support, consisting of oral or tube-fed dietary supplements; c. Antibiotics (oral or intravenous), if there is evidence of respiratory infection; d. Non-invasive positive pressure ventilation, if there is evidence of nocturnal hypoventilation or sleep-disordered breathing; e. Systemic steroids
16121572|NCT01999062|Other|IMRT + CT + MR scan|
16121573|NCT01999023|Dietary Supplement|Low protein formula group|Low protein formula formula (28.5 g) twice a day
16121574|NCT01999010|Device|MHT|MHT and visualizer contains mood information about the patient themselves, which allows for self management of the mood disorder. Self-management interventions promote early recognition of mood episodes, medication adherence and self-management skills which have shown to improve outcomes in depression. MHT encourages patients to take an active role by engaging in mood journaling, while making this information available in explorable form to the patient and his / her team of clinicians.
16121575|NCT01998997|Behavioral|Family educational intervention|The intervention is an educational intervention directed towards delirium prevention specifically for family members of hospitalized seniors. Family members will be encouraged to perform specific interventions that may decrease incident delirium.
16121576|NCT01998984|Drug|ingenol mebutate|
16121577|NCT01998984|Other|Placebo|
16121578|NCT01998971|Drug|Daratumumab|Administered by intravenous infusion in combination with the applicable backbone treatment.
16121579|NCT01998971|Drug|Velcade|Administered subcutaneously in accordance with product labeling and local standards.
16121580|NCT01998971|Drug|Pomalidomide|Administered orally in accordance with product labeling and local standards.
16121581|NCT01998971|Drug|Dexamethasone|Administered intravenously or orally in accordance with product labeling and local standards.
16121582|NCT01998971|Drug|Melphalan|Administered orally in accordance with product labeling and local standards.
16121583|NCT01998971|Drug|Prednisone|Administered intravenously or orally in accordance with product labeling and local standards.
16121584|NCT01998971|Drug|Thalidomide|Administered orally in accordance with product labeling and local standards.
16121585|NCT01998971|Drug|Diphenhydramine|Administered in prophylactic doses intravenously (or equivalent) in accordance with product labeling and local standards.
16121586|NCT01998971|Drug|Acetaminophen|Administered in prophylactic doses by mouth in accordance with product labeling and local standards.
16121587|NCT01998971|Drug|Carfilzomib|Administered intravenously in accordance with product labeling and local standards.
16121588|NCT01998971|Drug|Lenalidomide|Administered orally in accordance with product labeling and local standards.
16121589|NCT01998971|Drug|Montelukast|Administered intravenously or orally only with the first daratumumab dose in accordance with product labeling and local standards.
16121590|NCT01998958|Drug|Esketamine 14 mg|1 to 6 sprays of esketamine 14 mg self-administered as an intranasal formulation for 4 days (Days 1, 4, 8, 11) during the double-blind phase and if applicable during the optional open-label phase for up to 4 days
16121591|NCT01998958|Drug|Esketamine 28 mg|1 to 6 sprays of esketamine 28 mg self-administered as an intranasal formulation for 4 days (Days 1,4, 8, 11) during the double-blind phase and if applicable, during the optional open-label phase for up to 9 days
16121592|NCT01998958|Drug|Esketamine 56 mg|1 to 6 sprays of esketamine 56 mg self-administered as an intranasal formulation for up to 4 days (Days 1, 4, 8, 11) during the double-blind phase and if applicable, during the optional open-label phase for up to 9 days
16121593|NCT01998958|Drug|Esketamine 84 mg|1 to 6 sprays of esketamine 84 mg self-administered as an intranasal formulation for up to 4 days (Days 1, 4, 8, 11) during the double-blind phase and if applicable, during the optional open-label phase for up to 9 days
16121594|NCT01998958|Drug|Placebo|1 to 6 sprays of placebo self-administered as an intranasal formulation for 2 days (Days 1 and 4) or depending on response on Day 8, for 4 days (Days 1,4, 8, 11) during the double-blind phase
16121595|NCT01998945|Behavioral|Exposure-based Cognitive Behavioral Therapy|Eight 75-minute, in-home sessions delivered twice weekly for 4 weeks of exposure-based cognitive behavioral therapy, a time-limited treatment that focuses on confronting avoided memories and situations and identifying and managing distressing thoughts.
16121596|NCT01998945|Behavioral|Relaxation Training|Eight 75-minute, in-home sessions delivered twice weekly for 4 weeks of Relaxation Training, that focus on muscle relaxation and diaphragmatic breathing to address the physical symptoms of anxiety.
16121597|NCT01998919|Drug|erlotinib [Tarceva]|150 mg orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by 150 mg orally daily
16121598|NCT01998919|Drug|placebo|orally daily Days 15 to 28 of each 4-week cycle for 6 cycles, followed by daily oral application
16121602|NCT01998906|Drug|Trastuzumab|8mg/kg IV on Day 1 of Cycle 1, followed by 6 mg/kg on Day 1 of Cycle 2 up a maximum of Cycle 17
16121603|NCT01998906|Drug|Doxorubicin|60 mg/m2 IV on Day 1 of Cycles 1 through 3
16121604|NCT01998906|Drug|Paclitaxel|150 mg/m2 IV on Day 1 of Cycles 1 through 3, followed by 175 mg/m2 IV on Day 1 of Cycles 4 through 7
16121605|NCT01998906|Drug|CMF|CMF: Cyclophosphamide (600 mg/m2 IV bolus), methotrexate (40 mg/m2 IV bolus), 5-fluorouracil (600 mg/m2 IV bolus) on Day 1 of Cycles 8 through 10
16121606|NCT01998893|Drug|rituximab [MabThera/Rituxan]|375 mg/m2 iv weekly for 4 weeks; for responders to first course of therapy a second course is possible after relapse
16121607|NCT01998880|Drug|obinutuzumab|1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 [first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles).
16121608|NCT01998880|Drug|rituximab|375 mg/m^2 rituximab intravenous (IV) infusion on Day 1 of Cycle 1 (Cycle duration is 28 days) then 500 mg/m^2 IV infusions on Day 1 of Cycles 2-6.
16121609|NCT01998880|Drug|chlorambucil|Chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle.
16121610|NCT01998854|Device|VizAblate System|The VizAblate System is indicated for use in transcervical intrauterine-guided radio frequency ablation of uterine fibroids
16121611|NCT01998841|Drug|Crenezumab|Crenezumab will be administered subcutaneously (every 2 weeks) or intravenously (every 4 weeks) for at least 260 weeks.
16121612|NCT01998841|Drug|Placebo|Placebo matched to crenezumab will be administered subcutaneously (every 2 weeks) or intravenously (every 4 weeks) for at least 260 weeks.
16121613|NCT01998828|Drug|Momelotinib|Momelotinib tablet administered orally once daily
16121614|NCT01998815|Procedure|Laparoscopic Roux-en-Y gastric bypass surgery|
16121615|NCT01998802|Drug|Active Comparator EBI-005|
16121616|NCT01998802|Drug|Placebo Comparator|
16121617|NCT01998789|Drug|Everolimus|Everolimus will be initiated within 24 hours of baseline at a dose of 1 mg po BID (2 mg/day).
16121618|NCT01998789|Drug|Standard Tacrolimus|"Subjects will be maintained on standard maintenance immunosuppression per local protocol, consisting of a tacrolimus plus enteric coated mycophenolic acid. Oral corticosteroids may not be eliminated sooner than 180 days post transplantation.
~Tacrolimus doses will be adjusted based on local lab results of tacrolimus trough levels."
16121619|NCT01998776|Drug|Misoprostol|Misoprostol 200ug four times daily
16121620|NCT01998776|Drug|Placebo|Placebo Starch four times daily
16121621|NCT01998763|Dietary Supplement|Placebo|placebo capsules have similar appearance and smell as 400 IU vitamin D3 capsules,
16121622|NCT01998763|Dietary Supplement|Vitamin D3|Vitamin D3 2000 IU per day
16121623|NCT01998724|Behavioral|Tai Chi|24 week tai chi intervention designed for individuals with COPD
16121624|NCT01998724|Behavioral|Group Walking|24 week group walking intervention
16121625|NCT01998711|Behavioral|Memory group|Five 1-1.5 hour weekly session of memory training
16121626|NCT01998698|Procedure|Phacoemulsification surgery|Phacoemulsification surgery with intraocular lens implantation and monovision correction
16121627|NCT01998698|Procedure|Phacoemulsification surgery|Phacoemulsification surgery with multifocal intraocular lens implantation
16121628|NCT01998685|Drug|Propofol|
16121629|NCT01998685|Drug|remifentanyl|
16121630|NCT01998685|Drug|Midazolam|
16121631|NCT01998685|Drug|Fentanyl|
16121632|NCT01998685|Drug|Sevoflurane|
16121633|NCT01998672|Drug|Px-102|Px-102 drinking solution, 0.5 mg/kg, 1.0 mg/kg and 1.5 mg/kg
16121634|NCT01998672|Drug|Placebo|Drinking solution
16121635|NCT01998659|Drug|Px-102|Px-102 drinking solution, 7 single ascending doses from 0.15 mg/kg up to 4.5 mg/kg
16121636|NCT01998659|Drug|Placebo|Oral drinking solution
16121637|NCT01998646|Drug|ASP4058|Oral tablet
16121638|NCT01998646|Drug|Placebo|Oral tablet
16121639|NCT01998633|Biological|Hematopoietic Stem Cell Transplant|"NOTE: The - sign is the number of days before the transplant and the + sign is the number of days after the transplant.
~Alemtuzumab 0.2mg/kg Day-14,-13,-12,-11,-10
~Fludarabine 30 mg/m2 on Day -8,-7,-6,-5,-4
~Melphalan 140mg/m2 on Day -3
~The GVHD prophylaxis will consist of the following:
~Cyclosporine on Day -3 to Day +100, maintaining a level of 250-500 ng/mL, then taper to Day +180.
~Methylprednisolone 2 mg/kg/day on Day -2 and -1, 1 mg/kg/day on Day 0 to Day +28, then taper over 1 month. Oral prednisone may be substituted starting on Day 0 (1.2 mg/kg/day)"
16121640|NCT01998620|Drug|Ademetionine 2|Ademetionine 1000mg ivgtt qd with general antiviral treatment for 2 weeks, then Ademetionine 500mg po bid with general antiviral treatment for 8 weeks
16121641|NCT01998620|Drug|Ademetionine 1|Ademetionine 2000mg ivgtt qd with general antiviral treatment for 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks
16121642|NCT01998620|Drug|Ademetionine 3|no treatment for 2 weeks, then Ademetionine 1000mg bid po with general antiviral treatment for 8 weeks
16121643|NCT01998607|Other|Physician Survey|Eligible physicians will be contacted to perform the physician survey. A standardised online questionnaire will be used to collect information about the physician's awareness of the Summary of Product characteristics (SPC) pertaining to osteonecrosis of the jaw (ONJ) in the last 6-18 months.
16121644|NCT01998594|Procedure|Arthroplasty|A longitudinal dorsoradial incision is made from the base of the first metacarpal to the radial styloid for access to the thumb CMC joint. Trapeziectomy is performed piecemeal using sharp and blunt dissection. The base of the first metacarpal is then decorticated with a sagittal saw. A 4x7 cm sheet of thin FlexHD (HADM) is fashioned by a 4-0 monocryl suture imbrication into the size and shape of the subject's trapezium, keeping the dermal side exposed as much as possible. The allograft is secured with multiple interrupted 3-0 Ticron sutures and the bundle is placed into the post-trapeziectomy space. Additional suture fixation is performed between the FlexHD and the volar capsule of the trapezium, and base of the thumb metacarpal using 4-0 Mersilene sutures. The control treatment group will have the same trapeziectomy but without the placement of the FlexHD acellular dermal matrix.
16121645|NCT01998581|Device|JUVEDERM VOLBELLA® XC|Up to 1.5 mL per lip (upper and lower) at each treatment (initial, touch-up, and repeat treatment). Additional product may be injected into the perioral area, as long as the total injection volume does not exceed 6.0 mL. Up to 6.0 mL allowed for repeat treatment.
16121681|NCT01998321|Other|conventional technique for TKA|
16122483|NCT01992107|Biological|TIV2c|Novartis Investigational Vaccine
16121646|NCT01998581|Device|Restylane-L®|Up to 1.5 mL per lip (upper and lower) at each treatment (initial, touch-up, and repeat treatment). Additional product may be injected into the perioral area, as long as the total injection volume does not exceed 6.0 mL.. Up to 6.0 mL allowed for repeat treatment.
16121647|NCT01998568|Other|Intraocular pressure measurement|Using different tonometers for intraocular pressure measurement
16121648|NCT01998555|Other|CBT|
16121649|NCT01998542|Biological|AlloVax|Personalized anti-cancer vaccine with AlloStim(TM) and CRCL
16121650|NCT01998542|Biological|CRCL|autologous tumor-derived chaperone protein mixture
16121651|NCT01998542|Biological|AlloStim|AlloStim (ID) injection AlloStim (IV) infusion
16121652|NCT01998529|Drug|Cisplatin|Starting dose of hyperthermic cisplatin 120 mg/m2. Perfusion continued for 60 minutes after adding the cisplatin at a target temperature of 41 C (+0.5 C).
16121653|NCT01998529|Drug|Amifostine|Amifostine administered intravenously over 15 minutes beginning 30 minutes (+ 15 minutes) after the cisplatin perfusion.
16121654|NCT01998503|Drug|Bortezomib|
16121655|NCT01998503|Drug|dexamethasone|Given orally
16121656|NCT01998503|Biological|filgrastim|Given subcutaneous
16121657|NCT01998503|Procedure|autologous hematopoietic stem cell transplantation (ASCT)|Given on day 0
16121658|NCT01998503|Drug|Melphalan|
16121659|NCT01998490|Other|Animal-assisted activity|
16121660|NCT01998490|Other|Robot-assisted activity|
16121661|NCT01998477|Biological|TIVc|Madin Darby Canine Kidney (MDCK) cell culture derived subunit influenza vaccine TIVc contained the purified viral envelope glycoproteins, hemagglutinin (HA) and neuraminidase (NA) derived from 3 strains (including HA for each strain [A/H1N1-like, A/H3N2-like, and B-like]) intramuscular (IM) injection recommended by the WHO for the 2013-2014 influenza season in the Northern Hemisphere
16121662|NCT01998477|Biological|TIV|A conventional egg derived subunit influenza vaccine (TIV) contained the purified viral envelope-glycoproteins, HA and NA derived from 3 strains (including HA for each strain [A/ H1N1-like, A/H3N2-like, and B-like]) IM injection recommended by the WHO for the 2013-2014 influenza season in the Northern Hemisphere.
16121663|NCT01998451|Drug|Tauroursodeoxycholic acid|patients from double sphincter group and general gallbladder sphincter group all received Tauroursodeoxycholic acid after surgery for 6 months.
16121664|NCT01998438|Drug|Tranexamic Acid|The loading doses were given in 15 minutes when incision.
16121665|NCT01998399|Drug|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg BID for 90 days
16121666|NCT01998399|Drug|Placebo|Placebo 180 mg loading dose followed by 90 mg BID for 90 days.
16121667|NCT01998386|Other|Placebo gel without hydrogen peroxide|Castings will be made of the upper and lower arches of the volunteers and plaster will be poured into the molds. Individual plastic molds (vacuum form, flexible acetate 1 mm in thickness) will be made for each arch using the plaster models. After fitting the molds in the oral cavity, the volunteers will receive oral and written instructions on how to use the whitening gel and will be instructed to perform proper oral hygiene with dental floss and a tooth brush prior to the application of the whitening agent. The volunteers will be instructed to use the molds with the gel one hour a day for seven days. Thirty days after the beginning of treatment, the volunteers in this group will receive the whitening treatment with 6.0% hydrogen peroxide - White Class with calcium.
16121668|NCT01998386|Other|6.0% hydrogen peroxide - White Class|Castings will be made of the upper and lower arches of the volunteers and plaster will be poured into the molds. Individual plastic molds (vacuum form, flexible acetate 1 mm in thickness) will be made for each arch using the plaster models. After fitting the molds in the oral cavity, the volunteers will receive oral and written instructions on how to use the whitening gel 6.0% hydrogen peroxide - White Class with calcium and will be instructed to perform proper oral hygiene with dental floss and a tooth brush prior to the application of the whitening agent. The volunteers will be instructed to use the molds with whitening gel one hour a day for seven days.
16121669|NCT01998386|Other|7.5% hydrogen peroxide - White Class|Castings will be made of the upper and lower arches of the volunteers and plaster will be poured into the molds. Individual plastic molds (vacuum form, flexible acetate 1 mm in thickness) will be made for each arch using the plaster models. After fitting the molds in the oral cavity, the volunteers will receive oral and written instructions on how to use the whitening gel 7.5% hydrogen peroxide - White Class with calciumand will be instructed to perform proper oral hygiene with dental floss and a tooth brush prior to the application of the whitening agent. The volunteers will be instructed to use the molds with whitening gel one hour a day for seven days.
16121670|NCT01998386|Other|7.5% hydrogen peroxide - Oral-B 3D White|The participants in this group will receive four disposable whitening 7.5% hydrogen peroxide - Oral-B 3D White strips for daily individual use. The volunteers will be instructed to perform proper oral hygiene with dental floss and a tooth brush prior to the application of the whitening strips. The volunteers will receive oral and written instructions on how to use the whitening strips, which will be placed on the surface of the teeth for 30 minutes twice a day for seven days.
16121671|NCT01998373|Behavioral|training leaflet and oral training|The intervention consisted of training leaflet and oral training. All of the patients were new cases and were divided into 2 groups. All patients were treated with routine medication, no addition medication for two groups were done, the case group attended the workshops and were trained In addition to medical therapy, continuing education and training workshop. The result of the effect of workshop was also filling out a questionnaire before and after training. Finally, two groups with statistical analysis were compared.
16121672|NCT01998360|Procedure|Surgical Control|The study is quasi-experimental, because the open surgical controls are not contemporaneous. They were performed at the same center as part of Unicirc 001 trial with the same conditions as the subsequent 50 Unicirc circumcisions.
16121673|NCT01998360|Procedure|Unicirc with tissue adhesive|Excision of foreskin with Unicirc device and wound sealing with tissue adhesive
16121674|NCT01998347|Drug|Paclitaxel liposome|
16121675|NCT01998347|Drug|Cisplatin|
16121676|NCT01998347|Drug|5-fluorouracil|
16121677|NCT01998334|Other|CVVH 6h|CVVH 6h for first three days
16121678|NCT01998334|Other|CVVH 10h|CVVH 10h for first three days
16121679|NCT01998334|Other|CVVHDF 6h|CVVHDF 6h for first three days
16121680|NCT01998321|Other|Patient specific instrument|A special software with the ability to perform 3D planning including sizing, alignment, bone cutting, positioning of implants, simulation & PSI designing and PSI production
16121682|NCT01998308|Drug|Crespine gel|50 Knees will have single injection of Crespine gel
16121683|NCT01998308|Drug|Intragel|50 Knees will have single injection of 2 ampules of Intragel
16121684|NCT01998308|Drug|Crespine plus gel|50 Knees will have single injection of Crespine Plus Gel
16121685|NCT01998308|Drug|Monovisc|50 Knees will have single injection of Monovisc
16121686|NCT01998295|Drug|Artemether/lumefantrine|Medication was given at 0, 8, 24, 36, 48 and 60 hours. Food was given to all patients prior to medication to ensure proper absorption of the drug.
16121687|NCT01998256|Device|AV optimization|Iterative DFT (diastolic filling time) method for AV optimization. Optimal AV delay for both atrial sensed and atrial paced settings was defined by two experienced echocardiographists, after 3 separate measurements.
16121688|NCT01998243|Device|Intragastric Balloon (IGB), group A|the intervention was to place An intragastric balloon (BIOENTERICS INTRAGASTRIC BALLOON (BIB) SYSTEM) endoscopically under conscious sedation and was kept in the stomach during minimum 6 months. Patients were also treated with proton bomb inhibitors (PPI), and prokinetics to control gastroesophageal reflux . The balloon was endoscopically removed with the patient under general anesthesia to avoid bronco-aspiration related problems
16121689|NCT01998243|Other|diet, control group B|the intervention in this cotrol group B was only 1200 Kilocalories (Kcal) diet
16121690|NCT01998230|Dietary Supplement|early oral feeding|In the early oral feeding group, the patients are encouraged to intake liquid food on post operative day 1.
16121691|NCT01998217|Drug|Remifentanil|Patients in Rem group receive sedation and analgesia with remifentanil, dose of which will be determined by the up-and-down method.
16121692|NCT01998217|Drug|Flurbiprofen and remifentanil|Patients in this group receive sedation and analgesia with flurbiprofen and remifentanil, dose of which was determined by the up-and-down method.
16121693|NCT01998191|Other|Explicit case note review checklist (nurse)|"A checklist to be used to screen notes for features of avoidable death used by nurses.
~to be compared with 'Implicit Case note review (physician)' 'Implicit Case note review (MDT)' 'Implicit Case note review (nurse)' and the other two intervention arms."
16121694|NCT01998191|Other|Explicit case note review checklist (physician)|"A checklist to be used to screen notes for features of avoidable death, used by a nurse.
~to be compared with 'Implicit Case note review (physician)' 'Implicit Case note review (MDT)' 'Implicit Case note review (nurse)' and the other two intervention arms."
16121695|NCT01998191|Other|Explicit case note review checklist (MDT)|"A checklist to be used to screen notes for features of avoidable death used by a nurse and an expert physician.
~to be compared with 'Implicit Case note review (physician)' 'Implicit Case note review (MDT)' 'Implicit Case note review (nurse)' and the other two intervention arms."
16121696|NCT01998165|Drug|Remifentanil|After intubation, continuous intravenous infusion of remifentanil (0.25 µg/kg/min) is started, while anesthesia is maintained with inhaled or intravenous anesthetics. In cases where sedation by general anesthetics and analgesia by lidocaine does not seem to provide a sufficient means of analgesia at the time of intubation, remifentanil may be used, beginning before intubation. The rate of infusion may be adjusted while monitoring the subject's general condition in 25% to 100% increments or in 25% to 50% decrements every 2 to 5 minutes, but should not exceed 1.3 µg/kg/min.
16121697|NCT01998152|Procedure|Nutritional counseling|Patients in the intervention-arm will receive individualized nutritional counseling by a registered dietitian during standard treatment with chemotherapy. The main goals of the nutritional intervention will be to enable every patient to achieve sufficient protein and energy intake with attention for sufficient intake of micronutrients and a sufficient physical activity level.
16121698|NCT01998126|Drug|Ipilimumab|Ipilimumab 3 mg/kg x 4 (given with standard Erlotinib or Crizotinib based on mutation)
16121699|NCT01998126|Drug|Erlotinib|Erlotinib 150 mg once daily or current tolerable dose (given with Ipilimumab)
16121700|NCT01998126|Drug|Crizotinib|Crizotinib 250 mg twice daily or current tolerable dose (given with Ipilimumab)
16121701|NCT01998126|Drug|Nivolumab|
16121702|NCT01998113|Drug|Glyburide vs Insulin trials|Affecting groups 1 and 2
16121703|NCT01998113|Drug|Metformin vs Insulin trials|Affecting groups 3 and 4
16121704|NCT01998113|Drug|Metformin vs Glyburide trials|Affecting groups 5 and 6
16121705|NCT01998100|Behavioral|Prolonged Exposure|75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders.
16121706|NCT01998100|Behavioral|Exercise|30 minutes of moderate-intensity treadmill exercise prior to the Prolonged Exposure
16121707|NCT01998087|Behavioral|Breastfeeding support|A breastfeeding brochure will be distributed to expectant mothers from 20 weeks gestation during their regular antenatal visit. This will be followed 2 weeks later by a phone call offering clarification/explanation of the brochure. Three phone calls, offering breastfeeding support, will be conducted at 2,6 and 10 weeks following the birth of the baby.
16121708|NCT01998074|Dietary Supplement|extensively hydrolyzed rice protein formula|
16121709|NCT01998061|Drug|EGFR tyrosine kinase inhibitor|Arm A
16121710|NCT01998061|Drug|EGFR tyrosine kinase inhibitor with chemotherapy|Arm B
16121711|NCT01998048|Procedure|Latarjet|A diagnostic arthroscopy is performed before the Latarjet operation in general anaesthesia. In case of a significant Hill-Sachs defect an additional remplissage procedure may be performed according to surgeons' decision by inserting 1 to 2 more suture anchors according to surgeon's preference into the deepest portion of the Hill-Sachs defect and tying the infraspinatus tendon down to fill the bony defect. Thereafter an open Latarjet operation is performed using standard techniques described by Walch or de Beer. A deltopectoral incision is used. The coracoid process is osteotomized and ventrally prepared to bleeding bone. The coracoid process is then transferred through the middle of the subscapularis and re-attached on to the freshened neck of the glenoid, just medial to the joint line with two screws and washers, according to the surgeon's preference.
16121751|NCT01997710|Device|all-ceramic RBFDP|Rehabilitation of tooth loss with an all-ceramic RBFDP
16121752|NCT01997697|Other|behavior change program|behavior change program among patients with obesity
16121782|NCT01997385|Procedure|KAPD-C|KAPD-C is a treatment prescribed 2000 mL fill volume per each 4 cycles of dialysis session with an exchange cycle of 90 minutes.
16121783|NCT01997385|Procedure|KAPD-A|KAPD-A is a treatment initially prescribed 1500 mL fill volume per each 2 cycles of dialysis session with an exchange cycle of 45 minutes and followed by 2 cycles of 2500 mL fill volume with an exchange cycle of 135 minutes.
16121712|NCT01998048|Procedure|Bankart|An arthroscopic Bankart operation is performed in general anaesthesia according to current practise (Provencher 2010). The intra-articular findings are recorded and the anteroinferior labrum and the IGHL are mobilized until subscapular muscle fibers can be seen. The IGHL complex is then re-attached to the freshened neck of the glenoid with 2 to 3 suture anchors according to surgeon's preference to re-create labral bumper and capsular tension. In case of a significant Hill-Sachs defect an additional remplissage procedure may be performed according to surgeon's decision by inserting 1 to 2 more suture anchors, according to surgeon's preference into the deepest portion of the Hill-Sachs defect and tying the infraspinatus tendon down to fill the bony defect.
16121713|NCT01998035|Drug|Romidepsin|"Romidepsin is an anti-cancer (antineoplastic or cytotoxic) chemotherapy drug. Romidepsin is classified as a Histone Deacetylase Inhibitor.
~Dose escalation (10, 14 mg/m2)"
16121714|NCT01998035|Drug|Oral 5-Azacitidine|"A pyrimidine nucleoside analogue of cytidine with antineoplastic activity.
~Dose escalation (100, 200, 300 mg)"
16121715|NCT01998009|Other|fecal occult blood tests|
16121716|NCT01997983|Device|TC-3 Gel mixed with Botox (BTX)|TC-3 gel mixed with Botox (BTX). Single intravesical instillations of 40 ml of TC-3 mixed with 200 units of preconstitued BTX, using catheter
16121717|NCT01997970|Behavioral|Treadmill workstation|The intervention group will receive a treadmill workstation for 12 months. They will use this at self-selected speed and will be recommended to use this for at least 1 hour per day. Participants in the control group will continue with conventional office work at their regular desk. Participants in the intervention group will receive four boosting e-mails during the study period, in which they will be encouraged to use the treadmill.
16121718|NCT01997970|Behavioral|Health talk|Participants in both groups will receive a health talk with recommendations about diet and physical activity habits.
16121719|NCT01997957|Drug|S-1|Begin oral administration of S-1 from the 2nd day after TACE therapy plus arterial indwelling catheter chemotherapy (Oxaliplatin)
16121720|NCT01997944|Biological|Human Serum ALbumin/interferon alpha2a|600,750 or 900 mcg dosing every 2 weeks
16121721|NCT01997944|Biological|Pegasys|180 mcg dosing every week
16121722|NCT01997931|Device|Bispectral Index Sedation monitor|
16121723|NCT01997905|Device|AtriClip LAA Exclusion Device|
16121724|NCT01997879|Drug|AR-13324 Ophthalmic Solution, 0.02%|Eyedrop
16121725|NCT01997866|Other|STOP-BANG Scoring Model|Patients with Congestive Heart Failure on non-Intensive Care Unit Medical Services and/or visiting our outpatient Congestive Heart Failure Clinic will be administered the STOP-BANG Scoring Model to determine whether they are considered high-risk or low-risk for Sleep Apnea.
16121726|NCT01997866|Other|Polysomnogram Sleep Study|Patients determined by the STOP-BANG Scoring Model to be high-risk for Sleep Apnea will be referred to the Sleep Center physicians for evaluation and treatment. If medically indicated, a Polysomnogram Sleep Study will be performed.
16121727|NCT01997853|Drug|Omega 3 fatty acid|Patients with Chronic Periodontitis in Test Group were prescribed Omega 3 fatty acid tablets 300mg once daily for 12 weeks and SRP at baseline
16121728|NCT01997853|Drug|Placebo|Patients with Chronic Periodontitis in Control Group were prescribed Placebo tablets once daily for 12 weeks and SRP
16121729|NCT01997840|Drug|ACY-1215 (Ricolinostat) in combination with pomalidomide and dexamethasone|ACY-1215 (Ricolinostat) 160mg QD Days 1-21 with pomalidomide 4mg QD Days 1-21 and dexamethasone 40mg QD Days 1,8,15,22 of a 28-day cycle
16121730|NCT01997827|Device|metal-ceramic RBFDP|Rehabilitation of tooth loss with a metal-ceramic RBFDP
16121731|NCT01997827|Device|all-ceramic RBFDP|Rehabilitation of tooth loss with an all-ceramic RBFDP
16121732|NCT01997814|Drug|herbal immunomodulator|Patients in Test Group were treated with scaling and root planing (SRP) along with Herbal Immunomodulators (Septilin) therapy, 2 tablets twice daily for 3 weeks.
16121733|NCT01997814|Drug|Placebo|Patients in Control Group were treated with scaling and root planing (SRP) along with Placebo therapy, 2 tablets twice daily for 3 weeks.
16121734|NCT01997801|Drug|Ketamine infusion|Ketamine will be infused intraoperatively (0.25 mg/kg intravenous bolus following continuous infusion of 100 mcg/kg/hr).
16121735|NCT01997801|Drug|NS infusion|Normal saline will be infused intraoperatively.
16121736|NCT01997788|Drug|The intrathecal morphine injection|A single injection of morphine intrathecally
16121737|NCT01997788|Drug|The intravenous patient-controlled analgesia|The intravenous injection of morphine using the patient-controlled analgesia machine
16121738|NCT01997788|Drug|Demerol on demand|Demerol 25 mg intravenously when pain scores more than 5.
16121739|NCT01997775|Drug|METFORMIN|Participants enrolled in this study will be treated with either chemotherapy (Cisplatin 75mg/m2 plus Pemetrexed 500mg/m2 on D1) for 4 cycles or targeted therapy (Gefitinib 250mg/d) till disease progression according to physicians' decision. For participants with plasma IL-6 > 2.0 pg/mL after 2 cycles of chemotherapy or targeted therapy, Metformin 500mg orally qd will be given on Day 1 of cycle 3. If patient could tolerate it well, metformin will be titrated to 500mg bid in the following week (Cycle 3 D8) and 500mg tid in the 3rd week (Cycle 3 D15). For patients receiving chemotherapy, metformin will be used for total 12 weeks and plasma IL-6 level will be checked at the end of metformin treatment. For patients receiving targeted therapy, metformin will be used till disease progression and plasma IL-6 level will be measured after use of metformin for 12 weeks.
16121740|NCT01997762|Dietary Supplement|Resveratrol|gel-coated capsules to be taken twice a day; one with breakfast and dinner
16121741|NCT01997762|Dietary Supplement|Placebo|
16121742|NCT01997749|Dietary Supplement|Ketocal 4:1 (Nutricia)|
16121743|NCT01997749|Dietary Supplement|Control diet: Regular diet offered at the hospitals|
16121744|NCT01997749|Dietary Supplement|Ketogenic meals|
16121745|NCT01997736|Device|Ablation|
16121746|NCT01997723|Device|Portable monitoring|A device applied over 1 arm (on the wrist and finger), worn overnight by patients to detect OSA.
16121747|NCT01997723|Other|Polysomnography|One attended diagnostic sleep study.
16121748|NCT01997723|Device|Home portable monitoring|Portable monitoring with WP200 device - applied by participants once at home.
16121749|NCT01997723|Device|Laboratory portable monitoring|Portable monitoring with WP200 device - applied by technologist once in the laboratory simultaneously with polysomnography.
16121750|NCT01997710|Device|all-ceramic inlay-retained RBFDP|Rehabilitation of tooth loss with an all-ceramic inlay-retained RBFDP
16121753|NCT01997684|Procedure|Colonic Stenting with Elective Surgery|"After preparation of the distal colon with an enema, the colonoscope will be introduced up to the site of the obstruction. The colonic stent will be placed along a guide wire through the lesion under radiologic or endoscopic guidance. A colonic stent will be chosen which was at least 3 cm longer than the lesion (1.5 cm at either end). When the colonic stent did not cover the entire length of the lesion, a second overlapping stent will be placed.
~If the colonic stenting failed (technical failure) or symptoms of colonic obstruction did not resolve within 3 days (clinical failure), patients were indicated for emergency surgery.
~Candidates for elective surgery were preferably operated on 5-14 days after colonic stenting, and no later than 4 weeks.
~Type and extent of the surgery were selected by the surgeon, including but not limited to: loop colostomy, Hartmann's procedure, and (sub) total colectomy with ileostomy or ileorectal anastomosis."
16121754|NCT01997684|Procedure|Emergency Surgery|Type and extent of the surgery were selected by the surgeon, including but not limited to: loop colostomy, Hartmann's procedure, and (sub) total colectomy with ileostomy or ileorectal anastomosis.
16121755|NCT01997671|Other|Information Support System|Practitioners in the intervention group may have access, whenever they want and through the computerized medical record program, to personalized information on their assigned patients who have started treatment of cardiovascular primary prevention with lipid-lowering. This information is updated monthly for 12 consecutive months.Information will be presented in two different and complementary ways to each practitioner: asynchronous information (the patient is not present when the practitioner receives the information) and synchronous information (the patient is present when the practitioner receives the information).
16121756|NCT01997658|Drug|Methylprednisolone|Patients in Methylprednisolone arm will receive injection methylprednisolone 500 mg I/V over 15 to 20 minutes, single dose, 30 minutes before starting surgery.
16121757|NCT01997658|Drug|Placebo|Patients in the placebo group will receive standard perioperative care and surgery, without preoperative administration of methylprednisolone.
16121758|NCT01997645|Procedure|LIFT|
16121759|NCT01997645|Procedure|RAF|
16121760|NCT01997632|Biological|a single dose of monovalent high-dose inactivated poliovirus type 2 vaccine (m-IPV2 HD)|a single dose m-IPV2 HD (study vaccine), 0,5ml
16121761|NCT01997632|Biological|a single dose of the standard trivalent inactivated poliovirus vaccine (IPV)(Imovax Polio®).|a single 0.5 ml dose Imovax Polio (control vaccine)
16121762|NCT01997606|Other|use of Purotex treated bedding covers|Purotex is a textile treatment that uses five 100% natural bacteria or probiotics, selected for their ability to clean up house dust mite allergen along with other allergen types. The active probiotics are placed inside of millions of capsules and are introduced during the textile production. These human friendly bacteria remain non-active until friction force is created between the mattress/pillow and the sleeper's body. Under the friction force a small part of the capsules is opened and probiotics become active. They saturate the bacterial capacity of the textile and by doing so, reduce the risk of dust mite allergen development and growth of molds and harmful bacteria. The patients will apply the covers around their mattress and around their pillow. On top of these covers the patients will apply their own fitted sheet and pillowcase (which they will change every 4 weeks).
16121763|NCT01997606|Other|placebo|
16121764|NCT01997593|Drug|intraperitoneal infiltration of ropivacaine|intraperitoneal infiltration of ropivacaine by a special equipment
16121765|NCT01997580|Drug|escitalopram|SSRI antidepressant
16121766|NCT01997567|Drug|Ropivacaine|Subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of ropivacaine 0.5% with epinephrine 1:200,000 (150mcg) as a tracer for intravascular injection (total 30 ml)
16121767|NCT01997567|Drug|Placebo|Group 2 consented subjects will receive for their hip arthroscopy procedures general anesthesia (sevoflurane) with single femoral and lateral femoral cutaneous nerve blocks under ultrasound guidance, with 20 ml solution for the femoral block and 10 ml for lateral femoral cutaneous block, for a total of 30 ml solution of saline with epinephrine 1:200,000 (150 mcg) (total 30 ml)
16121768|NCT01997554|Other|Blood sample|An extra blood sample of 10 ml is collected
16121769|NCT01997528|Device|Change of blood flow or sweep gas flow ( ILA Activve)|
16121770|NCT01997515|Drug|Ketamine|Group K (ketamine) will receive 0.5mg /kg of ketamine bolus followed by an infusion of 0.5 mg/kg/hour of ketamine throughout the intraoperative period (Adjusted body weight).
16121771|NCT01997515|Drug|placebo|Group P (placebo) will receive the same amount of saline.
16121772|NCT01997502|Device|Pulse CO-Oximetry Technology|"In addition to the standard pulse oximeter used for clinical care, up to six SpHb finger sensors will be applied to the patient. Additional sensors may also be applied to the forehead, neck, chest and ears.
~Masimo FDA cleared pulse CO-Oximeter devices: Radical-7, Rad-87, Rad-57, Pronto, Pronto-7, for the noninvasive measurement of SpO2, PR, PI, PVI, SpCO, SpMet, and SpHb, total hemoglobin and respiratory rate.
~No treatment decisions will be made based on the new technology and no extra medical procedures are required for the study."
16121773|NCT01997502|Other|Blood draw|4mL arterial blood samples (up to 1 per hour), outside standard of care, are drawn throughout the surgical procedure and sent to UCDMC lab/Masimo lab for analysis.
16121774|NCT01997489|Drug|Enzyme replacement|Observational study of current treatment and with no comparative groups
16121775|NCT01997476|Procedure|Combined EUS, e-PFT and sEUS Testing|"advantage of combined EUS, ePFT & sEUS testing to provide a more definitive diagnostic assessment, rather than each test alone.
~Establish the advantage of reduced time and cost of combining EUS and ePFT, rather than when done separately."
16121776|NCT01997463|Drug|Supervised asthma therapy in schools|Therapy observed daily in school. Asthma education by American Lung Association
16121777|NCT01997437|Device|Stem-cell seeded bioartificial tracheal scaffold|Seeding the synthetic scaffold with autologous stem cells; scaffold' cultivation within 48-72 hours in bioreactor, injection of growth factors into scaffold in the first and last stages of the cultivation, replacement of the damaged trachea by generated tissue-engineered organ
16121778|NCT01997424|Device|Controlled Attenuation Parameter (CAP), Echosens, Paris, France|
16121779|NCT01997424|Device|FibroScan, Echosens, Paris, France|
16121780|NCT01997411|Drug|Nasal Glucagon|
16121781|NCT01997411|Drug|Intramuscular Glucagon|
16122009|NCT01995513|Drug|Prednisone|5 mg by mouth twice daily
16121784|NCT01997372|Drug|ATG|Drug ATG:2.5mg/kg/d or 3.75mg/kg/d for 5 days; Drug Cyclosporine A (CSA):3-10mg/kg/d ,Adjust the dose to maintain drug levels between 150 and 300ng/ml; Drug prednisone:1mg/kg/d,d1-21 from the first dosage of ATG; Drug Granulocyte Colony-Stimulating Factor(G-CSF):5ug/kg/d until absolute neutrophil count (ANC) >1×109/L.
16121785|NCT01997333|Drug|CDX-011|
16121786|NCT01997333|Drug|Capecitabine|
16121787|NCT01997320|Other|Heavy resistance exercise and nutrition|Heavy resistance exercise of the lower extremities three times weekly for 12 weeks.
16121788|NCT01997320|Other|Nutrition supplement|Two daily administrations of nutrient supplementation, each containing 20g of milk protein.
16121789|NCT01997294|Drug|Sequential therapy of atorvastatin|80mg atorvastatin before PPCI and 40mg/d for 7 days after PPCI
16121790|NCT01997281|Dietary Supplement|dietary fiber-enriched cereal|"provided with 300 mL (150 mL at 10 p.m.) of milk, total 3 times (day 1: 6 p.m. and 10 p.m., day 2: 8 a.m.)
~amount: 79g for dinner and breakfast, 38.5g for night snack (10 p.m.)
~one serving of steamed egg is added for dinner and breakfast"
16121791|NCT01997281|Other|conventional cereal|"provided with 300 mL (150 mL at 10 p.m.) of milk, total 3 times (day 1: 6 p.m. and 10 p.m., day 2: 8 a.m.)
~amount: 80 g for dinner and breakfast, 40 g for night snack (10 p.m.)
~one serving (40g) of steamed egg is added for dinner and breakfast"
16121792|NCT01997268|Drug|Placebo|Corn Oil
16121793|NCT01997268|Drug|SC401B 2 capsules|
16121794|NCT01997268|Drug|SC401B 4 capsules|
16121795|NCT01997268|Drug|SC401B 6 capsules|
16121796|NCT01997255|Drug|Everolimus|Afinitor tablets will be administered at a starting dosage of 5 mg/ m2/ day, dosed once per day in the morning. To achieve appropriate doses for all subjects 2mg, 3mg, 5mg of everolimus Disperz tablets will be used. Subjects will take one or more of these tablets in combination to achieve the required dose. Dosages will be rounded to the nearest 2 mg when calculating doses for individual subjects.
16121797|NCT01997229|Biological|Eculizumab|Induction Phase: 900 mg IV weekly X 4 Maintenance Phase: 1200 mg IV every 2 weeks during Weeks 4-26
16121798|NCT01997229|Drug|Placebo|Placebo
16121799|NCT01997216|Device|Delefilcon A multifocal contact lens|Investigational silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines
16121800|NCT01997216|Device|Lotrafilcon B multifocal contact lens|Commercially marketed silicone hydrogel contact lens dispensed in low, medium, or high ADD per current AIR OPTIX® AQUA MULTIFOCAL fitting guidelines
16121801|NCT01997203|Drug|Vitamin D|vitamin D was given to 50 patients (HCV under treatment)
16121802|NCT01997190|Biological|AdV-tk + valacyclovir|AdV-tk will be administered intrapleural through pleural catheter followed by oral valacyclovir. Valacyclovir will be administered orally at a fixed dose for 14 days after each AdV-tk administration.
16121803|NCT01997164|Drug|REGN910-3|
16121804|NCT01997164|Drug|REGN910|
16121805|NCT01997164|Drug|Intravitreal Aflibercept Injection (IAI)|
16121806|NCT01997151|Behavioral|Healthy Pregnancy: Step by Step|
16121807|NCT01997138|Drug|Anakinra 100 mg in 2 ml saline IA|
16121808|NCT01997125|Device|Neural Bridge System|Implanted device
16121809|NCT01997112|Drug|Paracetamol|
16121810|NCT01997112|Drug|Placebo oral capsule|
16121811|NCT01997099|Device|CADD®-Solis VIP Pump|
16121812|NCT01997099|Device|CADD™ Solis Medication Safety Software Administrator|
16121813|NCT01997086|Procedure|Percutaneous transforaminal endoscopic discectomy (PTED)|Percutaneous transforaminal endoscopic discectomy
16121814|NCT01997086|Procedure|Microendoscopic discectomy (MED)|Microendoscopic discectomy
16121815|NCT01997060|Behavioral|Intensive Lifestyle Intervention|
16121816|NCT01997034|Behavioral|Intensive Lifestyle Intervention|The included subjects has previously participated in the Intensive Lifestyle Intervention intervention at Ubberup Folk High School. This intervention includes daily exercise and a hypocaloric diet (app. -700KCal/day) for 10-14 weeks. Furthermore theoretical and practical education within e.g. Nutrition, exercise and motivational psychology.
16121817|NCT01997021|Other|US|US is a 5-hour intervention/condition where participants will be required to sit quietly for 5 consecutive hours.
16121818|NCT01997021|Other|IW|IW is a 24-hour intervention/condition where participants interrupt sedentary time with short 1.5 minute walking bout.
16121819|NCT01997021|Other|CW|CW is a 24-hour intervention/condition where participants perform a 36 minute continuous walking bout and are seated the remainder of the time.
16121820|NCT01997008|Behavioral|Intervention|Positive Affect Skills Training
16121821|NCT01996995|Device|Nd:YAG laser pulse therapy|
16121822|NCT01996995|Device|Sham procedure|Sham procedure
16121823|NCT01996982|Device|CCS Device|Core Cooling System Device
16121824|NCT01996969|Drug|Regorafenib|Regorafenib will be given 160mg once daily for 3 weeks, followed by a 1 week rest. Treatment will be continued until disease progression or unacceptable toxicity occurs. Response evaluation (CT scans) will be performed every 2 cycles.
16121825|NCT01996956|Other|volume expansion|fluid loading of 10 ml/kg colloid or blood product
16121826|NCT01996943|Drug|Ethanol|6% volume/volume ethanol in 0.45% saline solution.
16121827|NCT01996943|Drug|Placebo|"The placebo with be 0.45% saline solution (half normal saline)."
16121828|NCT01996930|Drug|Haelan tape (steroid impregnated tape)|Medicated plaster applied daily. Max daily dose = 0.1mg (25cm squared per day)Maximum duration of treatment = 28 days
16121829|NCT01996930|Drug|Silver Nitrate|Cautery with silver nitrate cutaneous stick undertaken twice weekly for a maximum duration of treatment = 28 days
16121830|NCT01996917|Device|Prineo|After a Wise pattern breast reduction, one breast will have final layer closure with Prineo, while the other breast will be closed in the standard fashion with sutures.
16121831|NCT01996904|Procedure|arthroscopic repair|If the subscapularis tendon was not sufficiently mobile, further anterior interval release between subscapularis and scapula was performed. LHB (long head of biceps tendon) was either treated with a biceps tenodesis or by tenotomy when there was tear or subluxation of it. The footprint area of the subscapularis tendon, which is trapezoidal in shape on the proximal part of the lesser tuberosity, was thoroughly cleaned of soft tissue and meticulous bone preparation was done prior to placement of anchor sutures.
16122010|NCT01995500|Device|BioNIR|drug-eluting stent
16122011|NCT01995500|Device|Resolute|drug-eluting stent
16121832|NCT01996904|Procedure|arthroscopic debridement|Anterosuperior portal was made initially for debridement (capsulectomy and anterior bursectomy). A systematic release of the glenohumeral ligaments and the overlying subscapularis bursa was performed.The superior aspect of the tendon was freed from the surrounding structures (the coracohumeral and superior glenohumeral ligaments). The middle glenohumeral ligament was always released to identify the upper border of the subscapularis tendon.
16121833|NCT01996891|Other|Anti-Inflammatory Diet|The anti-inflammatory diet will focus on reducing glycemic load, and increasing fiber, fruits, vegetables, legumes and food-based omega-3 fatty acid content.
16121834|NCT01996865|Drug|Lenalidomide|
16121835|NCT01996865|Drug|Rituximab|
16121836|NCT01996852|Behavioral|Cognitive-behavioral Meetings|"The cognitive-behavioral intervention will consist of six monthly in-person meetings and five telephone follow-ups. In-person meetings include a 90-minute educational group session and five 60-minute therapeutic couple-based meetings which partners are asked to attend. The telephone follow-ups last 15-30 minutes and take place two weeks after each in-person meeting. They will review progress and provide support.
~Each monthly meeting has a focused topic: Introduction, Guided imagery, Sensate focus, Communication and relationship issues, and Review.
~Homework will be assigned at the end of each meeting. Generally, participants are instructed (a) practice guided imagery daily, (b) engage in sexual activity 1-2 times/ week after sildenafil intake and (c) use the pump every day for 10min."
16121837|NCT01996852|Drug|sildenafil citrate|"100mg of sildenafil citrate will be given twice a week to interested patients. Participants may start Sildenafil at a lower dose when needed.
~To increase external validity, participants will be given the choice of using Sildenafil in the study."
16121838|NCT01996852|Device|Vacuum Constriction Device|"The medical treatment entails a 10-minute daily use of VCD (pump).
~The VCD (pump) is a FDA approved marketing product and has a brochure and DVD that explain its usage. The clinical trials unit (CTU) nurse will dispense the VCD at the drug pick-up time and document it on a Device Accountability Form. The study coordinator has received manufacturer's training and can address questions that a subject may have about VCD on site or through a phone call."
16121839|NCT01996839|Drug|Loteprednol Etabonate Gel (BID)|One drop of LE gel instilled into the study eye two times per day (BID) for 14 days
16121840|NCT01996839|Drug|Loteprednol Etabonate Gel (TID)|One drop of LE gel instilled into the study eye three times per day (TID) for 14 days.
16121841|NCT01996839|Drug|Vehicle (BID)|One drop of vehicle instilled into the study eye two times per day (BID) for 14 days
16121842|NCT01996839|Drug|Vehicle (TID)|One drop of vehicle instilled into the study eye three times per day (TID) for 14 days
16121843|NCT01996826|Drug|Avastin® (bevacizumab)|One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks.
16121844|NCT01996826|Drug|0.9% NaCl & Refresh Liquigel|One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks.
16121845|NCT01996813|Device|Thigh-high compression stockings|The intervention in this study are thigh-high compression stockings manufactured by Covidien.
16121846|NCT01996800|Procedure|Spinal Manipulative Therapy (SMT)|Spinal manipulation is a therapeutic intervention performed on spinal articulations which are synovial joints. These articulations in the spine that are amenable to spinal manipulative therapy include the z-joints, the atlanto-occipital, atlanto-axial, lumbosacral, sacroiliac, costotransverse and costovertebral joints.
16121847|NCT01996800|Procedure|SMT and Neuromuscular Reeducation|Neuromuscular reeducation is a general term that refers to techniques that attempt to retrain the neuromuscular system to function properly. The basis of this idea is that the formation of certain patterns of communication between muscles and nerves allow people to perform simple everyday acts such as climbing stairs.
16121848|NCT01996787|Device|Air Optix Aqua|Lenses will be worn on a daily wear basis (i.e. removed at night and stored in solution) and worn in the normal way. Lenses will be worn for one month. Lenses should be worn for a minimum of six hours a day, four days a week. The lenses are also to be worn for a minimum of two hours before attending all follow-up visits.
16121849|NCT01996787|Device|Clariti with Handling Tint|Lenses will be worn on a daily wear basis (i.e. removed at night and stored in solution) and worn in the normal way. Lenses will be worn for one month. Lenses should be worn for a minimum of six hours a day, four days a week. The lenses are also to be worn for a minimum of two hours before attending all follow-up visits.
16121850|NCT01996761|Drug|porcine brain peptide (Cerebrolysin)|
16121851|NCT01996761|Drug|Placebo|
16121852|NCT01996748|Drug|DF277|Two administrations daily for 7 days
16121853|NCT01996748|Drug|Placebo|Two administrations daily for 7 days
16121854|NCT01996735|Drug|Ticagrelor 180 mg single dose|
16121855|NCT01996735|Drug|Placebo|
16121856|NCT01996709|Device|Hydrogen peroxide-based contact lens solution|
16121857|NCT01996709|Device|Habitual contact lens solution|Biguanide-preserved
16121858|NCT01996709|Device|Habitual contact lenses|Silicone hydrogel contact lenses with a biweekly or monthly replacement schedule
16121859|NCT01996696|Drug|Metformin|Metformin 500 mg PO TID x 30-36 months
16121860|NCT01996696|Drug|Placebo|Identical placebo TID x 30-36 months
16121861|NCT01996683|Drug|desferal, ferriprox, blood transfusion|"Deferiprone (75-100 mg/kg/d) and deferoxamine (20-60 mg/kg/d) aimed at achieving normal body iron stores in poly-transfued arm1.
~Arm 2 will only recieve blood transfusion with no chelation"
16121862|NCT01996657|Drug|Warfarin|
16121863|NCT01996644|Drug|Placebo vs Setraline|Placebo
16121864|NCT01996644|Drug|Setraline|250mg DCS
16121865|NCT01996618|Drug|Ranolazine|After the initial 6 days of treatment with ranolazine, 500 mg twice daily or matched placebo, subjects will undergo repeat 24 hour electrocardiographic monitoring. If tolerated, the subjects will then have their study medication increased (Ranolazine 1,000 mg twice daily) with the plan to then undergo a repeat 24 hour ambulatory electrocardiographic monitoring in 6 days.
16121866|NCT01996605|Drug|Oxytocin 15 mcg|Oxytocin 15 mcg will be administered spinally
16121867|NCT01996605|Drug|Oxytocin 150 mcg|Oxytocin 150 mcg will be administered spinally
16121868|NCT01996605|Drug|Placebo|placebo will be administered spinally
16122012|NCT01995487|Device|BioNIR|drug-eluting stent
16122013|NCT01995487|Device|Resolute|drug-eluting stent
16121869|NCT01996579|Dietary Supplement|Lactoferrin|Lactoferrin is an 80 kilodalton (kD) naturally occurring multifunctional glycoprotein of the transferrin family which is an important component of the human innate immune system. Lactoferrin is distributed widely in humans with the main sources of production being exocrine glands and specific granules of neutrophils. It is present in virtually all human secretions. The highest concentrations are found in milk and colostrum. Lactoferrin has multiple biological functions which make it of interest as a therapeutic agent in the critically ill. These include the ability to bind iron, antimicrobial activity including antibacterial, antifungal, antiviral properties, the ability to bind endotoxin, promotion of beneficial bacteria in the gastro-intestinal tract and immunomodulatory activity.
16121870|NCT01996579|Other|Placebo|Sterile water will be utilized as the placebo control in this double blind randomized-controlled trial.
16121871|NCT01996540|Other|Interventional arm: Early best palliative care|Patients will receive standard oncologic care and will be assigned to early systematic best palliative care. They will meet a member of the palliative care team within 2 weeks after enrolment. Thereafter, they shall be visited by a palliative care team member every 2 weeks until death.
16121872|NCT01996527|Device|3-Tesla magnetic resonance imaging|3-Tesla MRI is a multiparametric imaging exam that includes MR pulse sequences for CEST-MRI, DW-MRI, DCE-MRI, and DSC-MRI
16121873|NCT01996527|Device|CEST-MRI|Undergo CEST-MRI
16121874|NCT01996527|Device|DW-MRI|Undergo DWI-MRI
16121875|NCT01996527|Device|DCE-MRI|Undergo DCE-MRI
16121876|NCT01996527|Device|DSC-MRI|Undergo DSC-MRI
16121877|NCT01996527|Drug|IV administration of gadolinium-containing contrast agent|Gadolinium-containing paramagnetic contrast agent (Magnevist®; Berlex Lab, Wayne, New Jersey) in delivered via intravenous (IV) infusion to achieve DCE and DSC contrast
16121878|NCT01996514|Dietary Supplement|Glucose with water|Glucose (1.0 g•kg-1 body weight ) in 250 mL of water 30 min before meal
16121879|NCT01996514|Dietary Supplement|non-caloric sweetener with water|0.15 g of the high-intensity sweetener, Splenda sucralose in 250 mL of water 30 min before meal
16121880|NCT01996514|Behavioral|TV program with non-food advertisements while feeding|30 minutes of TV program containing non-food ads during a meal
16121881|NCT01996514|Behavioral|TV program with food advertisements while feeding|30 minutes of TV program containing non-food ads during a meal
16121882|NCT01996501|Drug|Olanzapine Orally Disintegrating 5mg Tablets|
16121883|NCT01996488|Drug|Olanzapine Orally Disintegrating Tablets 5mg|
16121884|NCT01996475|Drug|Escitalopram Oxalate Tablets|
16121885|NCT01996462|Drug|Escitalopram Oxalate Tablets|
16121886|NCT01996449|Drug|Eplerenone|The subject will be started on Eplerenone (Inspra) 50-200mg daily, which he or she will continue for a period of 8 weeks. Following the 8-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued
16121887|NCT01996449|Drug|Amlodipine|The subject will be started on Amlodipine (Norvasc) 2.5 -10mg daily, which he or she will continue for a period of 8 weeks. Following the 8-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.
16121888|NCT01996449|Procedure|Microneurography|Investigators will measure sympathetic nerve activity from the peroneal nerve by inserting a tiny needle directly into the nerve in the leg. Investigators will localize the nerve by electrical stimulation over the skin using a blunt probe. With this stimulation, subject will notice either involuntary twitching or a tingling sensation, which may be annoying but not painful. Investigators will then introduce a tiny, sterile wire needle (an electrode) through the skin at the same location. When the tip of the needle enters the nerve, subjects may again notice involuntary muscle twitches or tingling in the leg. Investigators will then turn the electrical stimulator off and make minor adjustments in the position of the needle until investigators begin to record the nerve signals. The recording needle will remain in position throughout the study.
16121889|NCT01996449|Procedure|Rhythmic handgrip exercise|Subjects will perform a rhythmic handgrip exercise at 30% or 45% of maximal voluntary contraction for 3 minutes. Investigators will measure cardiac output (non-invasive impedance plethysmography), blood pressure, and sympathetic nerve activity (SNA) at baseline and following this handgrip exercise
16121890|NCT01996449|Procedure|Sustained hand grip|Subjects will perform a sustained handgrip exercise at 30% of maximal voluntary contraction for 3 minutes. Investigators will measure cardiac output (non-invasive impedance plethysmography), blood pressure, and sympathetic nerve activity (SNA) at baseline and following this handgrip exercise.
16121891|NCT01996449|Procedure|Forearm blood flow|Using high-resolution ultrasound, investigators will measure skeletal muscle blood flow in the forearm at rest, following sustained handgrip exercise
16121892|NCT01996449|Procedure|Arm cycling exercise|Subjects will perform a cycling arm exercise with a stationary cycling device. Investigators will measure cardiac output (non-invasive impedance plethysmography), blood pressure, and sympathetic nerve activity (SNA) at baseline and following this exercise.
16121893|NCT01996449|Procedure|Cold Pressor test|Subjects will place hand in cold water with ice for 3 minutes. Investigators will measure cardiac output (non-invasive impedance plethysmography), blood pressure, and sympathetic nerve activity (SNA) at baseline, during and 2 minutes after the test.
16121897|NCT01996423|Dietary Supplement|Vitamin D3|
16121898|NCT01996423|Dietary Supplement|Placebo|
16121899|NCT01996410|Device|Acupuncture|
16121900|NCT01996397|Procedure|Cardiac resynchronization therapy device implantation|
16122014|NCT01995474|Other|Twisted Syringe|briefly disconnecting the syringe from the biopsy channel after a specimen is obtained and then reconnecting it
16122015|NCT01995474|Other|Conventional Technique|syringe is exchanged for the needle stylet and negative pressure is applied allowing acquisition of a cytology specimen.
16122108|NCT01994928|Device|Nose-mouth mask|Preoxygenation using a nose-mouth mask.
16122109|NCT01994928|Device|High flow nasal cannula oxygen|Preoxygenation using high flow nasal cannula oxygen.
16121901|NCT01996384|Procedure|Classical Acupuncture|Very thin needles (0.18mm) will be inserted into locations either on the front or the back of the body and may be placed near or far from the affected area. No needles will be inserted into the genital region. Locations needled will be in classical acupuncture points. On even-numbered visits, the needles may be electrically stimulated via an electro-acupuncture machine. Needles will be retained for 30 minutes per study visit. Acupuncture needles used are 0.18x30-40mm, manufactured by Dong Bae Corporation (DBC), Korea. The electrical acupuncture device is Pantheon Research Electrical Stimulator 8c, United States.
16121902|NCT01996384|Procedure|Non-classical acupuncture|Very thin needles (0.18mm) will be inserted into locations either on the front or the back of the body and may be placed near or far from the affected area. No needles will be inserted into the genital region. Locations needled will be in non-classical acupuncture points. On even-numbered visits, the needles may be electrically stimulated via an electro-acupuncture machine. Needles will be retained for 30 minutes per study visit. Acupuncture needles used are DBC Brand, Korea, 0.18x30-40mm. The electrical acupuncture device is Pantheon Research Electrical Stimulator 8c, United States.
16121903|NCT01996384|Drug|Lidocaine|Study participants will gently apply 5% lidocaine cream four times daily to vulvar area.
16121904|NCT01996371|Device|Pedicle Screw|
16121905|NCT01996358|Drug|Succinylcholine|Anaesthesia is induced and maintained with propofol (1-2 mg/kg) and remifentanil (0,5 µg/kg). The study arm is immobilized and after cleaning the skin a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. After induction of anaesthesia the patient receives muscle relaxant according to the study group.
16121906|NCT01996358|Drug|Rocuronium 0,3|General anaesthesia is induced and maintained with propofol (1-2mg/kg) and remifentanil (0,5µg/kg). The study arm is immobilized and after cleaning the skin a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. The Patient receives the muscle relaxant according to the study group.
16121907|NCT01996358|Drug|Rocuronium 0,6|General anaesthesia is induced and maintained with propofol (1-2mg/kg) and remifentanil (0,5µg/kg). The study arm is immobilized and after cleaning the skin a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. The Patient receives the muscle relaxant according to the study group.
16121908|NCT01996345|Procedure|Cervical Pessary Placement|For the patients assigned to receive a cervical pessary, they will be evaluated and fitted for a pessary by the physician within 3-4 days unless exclusion criteria develop. After it is placed she will be evaluated for comfort. She will be asked to leave it in at all times but informed that removal and withdrawal from the study is always her option.
16121909|NCT01996332|Drug|erlotinib [Tarceva]|150 mg/day until progressive disease or unacceptable toxicity
16121910|NCT01996319|Drug|QVA149|QVA149 (110/50 µg) once a day via Breezhaler® device
16121911|NCT01996319|Drug|Placebo|Placebo once a day via Breezhaler® device
16121912|NCT01996306|Biological|Bevacizumab|5 mg/kg intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on day 1 of a 2-week cycle.
16121913|NCT01996306|Drug|CPT-11 (Irinotecan)|150-180 mg/m2 intravenously administered over 90 minutes on day 1 of a 2-week cycle.
16121914|NCT01996306|Drug|5-FU Bolus|400 mg/m2 intravenous bolus on day 1 of a 2-week cycle.
16121915|NCT01996306|Drug|5-FU Infusion|2400 mg/m2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle.
16121916|NCT01996306|Drug|l-LV (dl-LV)|200 (dl-LV: 400) mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle.
16121917|NCT01996306|Biological|bevacizumab|7.5mg/kg IV intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on Day 1 of a 3-week cycle.
16121918|NCT01996306|Drug|CPT-11 (Irinotecan)|150-200 mg/m2 intravenously administered over 90 minutes on day 1 of a 3-week cycle.
16121919|NCT01996306|Drug|Capecitabine|1600mg/m2/day oral on day 1 (evening) to day 15 (morning)of a 3-week cycle.
16121920|NCT01996293|Drug|lamotrigine|Lamotrigine will be observed in women who have already under the guidance of a physician decide to continue lamotrigine for the treatment of Bipolar Disorder
16121921|NCT01996280|Behavioral|Motivational Interviewing|The MI is a single brief motivational intervention lasting 1.5 hrs. The MI includes MI structured strategies tailored to the patient's readiness to change such as: the Typical Day exercise, the use of personal feedback reports (e.g., normative feedback about their drinking), discussions about the pros and cons of use, and completion of a change plan; It is designed to follow MI principles of invoking autonomy and emphasizing collaboration with the interventionist.
16121922|NCT01996280|Behavioral|Culturally Tailored MI|CTMI is a single brief motivational intervention lasting 1.5hrs. The CTMI follows the same sequence of structured strategies as the MI arm, and while the components in CTMI and MI are parallel, the focus within them is different. CTMI components culturally relevant material, such as acculturation stress. The CTMI components, which are MI structured strategies, are culturally tailored to address relevant concerns and issues. There are also culturally tailored feedback element, such as ethnic normative feedback related to drinking.
16121925|NCT01996254|Device|SPRINT Peripheral Nerve Stimulation (PNS) System|"The SPRINT System is an Investigational Device which delivers mild electrical stimulation to nerves in the residual limb. The SPRINT System includes a small wire (called a Lead) that is placed through the skin in the upper leg. It also includes a device worn on the body that delivers stimulation (called the SPRINT Stimulator)."
16121926|NCT01996241|Behavioral|Multi-level, structural and norms-based intervention|Receive multi-level, structural and norms-based intervention
16121927|NCT01996228|Device|Stem Cell Educator|
16121928|NCT01996202|Drug|Ipilumimab|
16121929|NCT01996202|Radiation|Radiation|
16121930|NCT01996189|Device|Standard needle BBraun Sterican® 23G and 25mm in length|Arterial puncture using the hypodermic needle (BBraun Sterican® 23G and 25mm in length) attached to a 3 ml syringe.
16121931|NCT01996189|Device|Insulin|Arterial puncture using the insulin syringe (Terumo®- 0.5 ml with attached needle 29G and 13mm in length)
16122064|NCT01995188|Drug|Bevacizumab|Bevacizumab 15 milligrams per kilogram (mg/kg) administered via IV infusion on Day 1 of each 21-day cycle until disease progression or death, whichever occurs first.
16121932|NCT01996176|Behavioral|Intervention group|"The intervention consists of four components, which as described below:
~Information about sedentary behaviour and health: Delivered at the kick-off workshop, in a leaflet and the project website.
~Local adaptation: Participants adapt the intervention to their personal and local environment setting individual and common goals. Local ambassadors are chosen and support from the management is emphasised.
~Structural changes: Facilities for standing meetings, both formal and informal. Routes for walking meetings should be defined.
~Individual support: At the kick-off workshop participants set individual goals. The individual can choose to receive e-mails and text messages (SMS)from the project. The individual receives a post-it block and a postcard to remind them of the project."
16121933|NCT01996176|Behavioral|Control group|The control group receives the intervention after the last follow-up, the exact time will be settled together with each workplace in the control group.
16121934|NCT01996150|Drug|bleach bath (sodium hypochlorite)|Subjects will take diluted bleach bath (0.005% Sodium Hypochlorite) for 5-10 minutes twice a week for 12 weeks.
16121935|NCT01996137|Device|VASST II treadmill|Supervised treadmill training under physiotherapist
16121936|NCT01996124|Drug|Indacaterol Fumarate|150 mcg inhalation powder, hard capsules, once daily
16121937|NCT01996124|Drug|Placebo|Fructose, dry inhalation powder, hard capsules via breezhaler
16121938|NCT01996111|Procedure|Injection of 1.0 cc of 0.9% Saline|Injection of 1.0 cc of 0.9% Saline into affected area
16121939|NCT01996111|Procedure|Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension|Injection of 1.0 cc of 10 mg/ml micrograft dHACM suspension into affected area
16121940|NCT01996111|Procedure|Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspension|Injection of 1.0 cc of 20 mg/ml micrograft dHACM suspension into affected area
16121941|NCT01996111|Procedure|Injection of 1.0 cc of 40 mg/ml micrograft dHACM suspension|Injection of 1.0 cc of 40 mg/ml micrograft dHACM suspension into affected area
16121942|NCT01996098|Drug|6-month Icotinib|125 mg three times daily (375 mg per day) by mouth for 6 months
16121943|NCT01996098|Drug|12-month icotinib|125 mg three times daily (375 mg per day) by mouth for 12 months
16121944|NCT01996085|Drug|lisinopril|"Angiotensin converting enzyme inhibitor recommended in case of:
~hyperconstrictive profile (SVRI > 2500-2800 dyn•s•cm-5•m2)
~hyperdynamic profile (CI > 4.2 l/min/m2 and/or HR > 80/min) and office SBP ≥ 160 mm Hg and/or DBP ≥ 100 mmHg and/or 24-h mean SBP ≥ 140 mm Hg and/or 24-h mean DBP ≥ 90 mm Hg (in combination with nebivolol)
~hypervolemic profile (man - TFC > 34 1/kOhm; women - TFC > 24 1/kOhm) and office SBP ≥ 160 mm Hg and/or DBP ≥ 100 mmHg and/or 24-h mean SBP ≥ 140 mm Hg and/or 24-h mean DBP ≥ 90 mm Hg (in combination with diuretic)
~balanced profile"
16121945|NCT01996085|Drug|Telmisartan|Angiotensin receptor blocker recommended in terms as for lisinopril in case of its intolerance (e.i. cough)
16121946|NCT01996085|Drug|Nebivolol|"Beta-blocker recommended in case of:
~1.hyperdynamic profile (CI > 4.2 l/min/m2 and/or HR > 80/min)"
16121947|NCT01996085|Drug|Indapamide/hydrochlorothiazide|"hypervolemic profile (man - TFC > 34 1/kOhm; women - TFC > 24 1/kOhm)
~hyperconstrictive profile (SVRI > 2500-2800 dyn•s•cm-5•m2) and office SBP ≥ 160 mm Hg and/or DBP ≥ 100 mmHg and or 24-h mean SBP ≥ 140 mm Hg and/or 24-h mean DBP ≥ 90 mm Hg (in combination with lisinopril/telmisartan)"
16121948|NCT01996085|Drug|Amlodipine|1/ SVRI > 2800 dyn•s•cm-5•m2 (in combination with lisinopril/telmisartan)
16121949|NCT01996085|Drug|lisinopril|Drug choice at the discretion of physician (blinded to ICG)
16121950|NCT01996085|Drug|Telmisartan|Angiotensin receptor blocker recommended as for lisinopril in case of its intolerance (e.i. cough)
16121951|NCT01996085|Drug|Nebivolol|Drug choice at the discretion of physician (blinded to ICG)
16121952|NCT01996085|Drug|Indapamide/hydrochlorothiazide|Drug choice at the discretion of physician (blinded to ICG)
16121953|NCT01996085|Drug|Amlodipine|Drug choice at the discretion of physician (blinded to ICG)
16121954|NCT01996072|Drug|EC17|
16121955|NCT01996059|Procedure|Functional Jejunal Interposition|First, an end-to-side esophagojejunostomy was performed at 40 cm anal to Treitz's ligament. Then, an end-to-side duodenojejunostomy was created at the efferent limb 35 cm distal to the esophagojejunostomy, followed by a side-to-side jejunostomy at 5 cm distal to duodenojejunostomy and 20 cm distal to Treitz's ligament. Finally, 2 jejunal proper ligations were made at 5 cm oral to esophagojejunostomy and 2 cm distal to duodenojejunostomy.
16121956|NCT01996059|Procedure|Roux-en-Y|The distal end of the duodenum was closed. The jejunum was separated 15-20cm distal to the Treitz's ligament, and an end-to-side esophagojejunostomy was done at the distal side of the jejunum. Then, the continuity of the jejunum was reconstructed with side-to-end jejunojejunostomy at 40-45cm distal to esophagojejunostomy.
16121957|NCT01996046|Other|FDG PET/CT scan|[18F] FDG PET/CT scan at 4 weeks after starting new hormonal therapy
16121958|NCT01995981|Drug|Pazopanib|
16121959|NCT01995968|Other|Antenatal identification of fetal growth restriction|"FGR is considered as identified if:
~FGR was mentioned in medical charts
~OR at least one ultrasound fetometry had indicated an estimated fetal weight or an abdominal diameter below the 10th percentile (whatever the reference curve used)
~OR no (or insufficient) weight gain between two ultrasounds mentioned in medical charts
~OR pathological Doppler examination of the umbilical artery (absent or reversed blood flow at the end of diastole)
~OR utero-placental Doppler ultrasound indicated for suspicion of growth failure"
16121960|NCT01995955|Procedure|a new non-invasive imaging technique|a new non-invasive imaging technique for evaluation of cardiac microciculation in coronary artery disease
16121961|NCT01995929|Procedure|transnasal functional endoscopy|
16121962|NCT01995916|Behavioral|Mindfulness Intervention|The Mindfulness Group will meet once a week for 2.5 hours for 8 weeks with a half day retreat.
16121963|NCT01995916|Behavioral|Social Support Group|The Social Support Group will meet once a week for 2.5 hours for 8 weeks with a half day retreat.
16121964|NCT01995903|Diagnostic Test|MRI(magnetic resonance imaging)|Subjects with amyotrophic lateral sclerosis and lower neuron motor skills and healthy subjects will undergo an MRI(magnetic resonance imaging)scans of the brain to assess neurologic condition. The brain scans will take approximately 60 minutes to complete.
16121965|NCT01995890|Drug|nepafenac|
16122065|NCT01995188|Drug|Carboplatin|Carboplatin fixed dose of AUC=6 mg/mL*min administered by IV infusion on Day 1 of each 21-day dose escalation and expansion cycles. Carboplatin will be administered for a maximum of 6 cycles or until disease progression or unacceptable toxicity, whichever is first.
16121966|NCT01995877|Procedure|Subjects scheduled for IVC filter placement|"Subjects will have an intra vascular ultrasound (IVUS) performed while lying down on the exam table; this will be performed before and after the IVC (inferior vena cava) filter is placed. During the ultrasound, measurements of the diameter of different areas of the IVC will be taken. The table will then be moved so that you are in a standing position and the measurements will be taken again.
~The ultrasound will be done by the physician performing your procedure. When you are lying down, a sheath (small catheter) will be inserted into a vein in your groin. The IVUS (intra vascular ultrasound) catheter will be inserted through the sheath and used to measure the size of the IVC at various places.
~The IVUS procedure will add about 30-45 minutes to the filter placement procedure."
16121967|NCT01995864|Behavioral|CTI-TS|"The following briefly describes the three phases of CTI-TS:
~Phase 1: Initiation: The client and CTI-TS team formulate a treatment plan that focuses on selected areas identified as crucial for strengthening stability and facilitating the assimilation of the individual into community living.
~Phase 2: The Try-Out phase is devoted to testing and adjusting the support systems that have been established in the community.
~Phase 3: The final phase, Transfer of Care, is devoted to making any necessary improvements in the network of supports of the individual."
16121968|NCT01995838|Drug|E2006|E2006 1 mg, 2.5 mg, 5 mg, 10 mg, 15 mg, or 25 mg, in tablet form, taken orally, 30 minutes prior to bedtime, each night for 15 consecutive nights
16121969|NCT01995838|Drug|Placebo|E2006-matched placebo in tablet form, taken orally, 30 minutes prior to bedtime, each night for 15 consecutive nights
16121970|NCT01995825|Drug|Brand lamotrigine|Brand lamotrigine tablet 100mg tablets (1-3 either once or twice a day) for two weeks
16121971|NCT01995825|Drug|Generic lamotrigine|Generic lamotrigine tablet 100mg tablets (1-3 either once or twice a day) for two weeks
16121972|NCT01995812|Behavioral|Hula and heart health education|
16121973|NCT01995799|Device|Ferumoxytol enhanced MRI|Ferumoxytol enhanced MRI scan
16121974|NCT01995786|Device|Goal Directed Fluid Therapy FloTrac/Vigileo|
16121975|NCT01995734|Drug|Pasireotide long acting release formulation|Pasireotide LAR will be administered intramuscularly (i.m.) every 28 days until pasireotide becomes commercially available and reimbursed or until 31 December 2015, whichever occurs first.
16121976|NCT01995721|Biological|4-valent HPV vaccine|Vaccination with 4-valent HPV vaccine in months 0., 2., 6.
16121977|NCT01995708|Biological|CT7, MAGE-A3, and WT1 mRNA-electroporated Langerhans cells ( LCs)|Patients receive CT7/MAGE-A3/WT1 mRNA-electroporated autologous Langerhans-type dendritic cells ID on days 12, 30, and 90 after autologous stem cell transplant. Patients on the vaccine arm of the study will receive a total of 3 vaccinations, comprising a primary immunization on day +12 after ASCT followed by two boosters at days +30 and +90. Vaccines will be dosed at 9x10^6 LCs per vaccine x 3.
16121978|NCT01995708|Other|Standard of care|No vaccines
16121979|NCT01995695|Biological|Live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine|Participants will receive approximately 10^7.0 focus forming units (FFU) of the live attenuated H7N9 A/Anhui/13 ca influenza virus vaccine. The vaccine will be delivered by an Accuspray nasal spray device (0.25 mL per nostril for a total of 0.5 mL of vaccine).
16121980|NCT01995695|Biological|Inactivated subvirion H7N9 influenza vaccine|Participants will receive 30 mcg of the inactivated subvirion H7N9 vaccine by intramuscular injection.
16121981|NCT01995669|Other|Laboratory Biomarker Analysis|Correlative studies
16121982|NCT01995669|Drug|Lenalidomide|Given PO
16121983|NCT01995669|Biological|Obinutuzumab|Given IV
16121984|NCT01995656|Drug|Placebo - Capsule|Administered orally
16121985|NCT01995656|Drug|LY3108743 - Capsule|Administered orally
16121986|NCT01995656|Drug|Placebo - Solution|Administered orally
16121987|NCT01995656|Drug|LY3108743 - Solution|Administered orally
16121988|NCT01995643|Dietary Supplement|Active Capsule|GSE Capsule
16121989|NCT01995643|Dietary Supplement|Placebo Capsule|Placebo Capsule
16121990|NCT01995630|Device|AMO Tecnis ZA9003|
16121991|NCT01995630|Device|AMO Sensar AR40e|
16121992|NCT01995617|Biological|Placebo|normal saline, 0.5 mL per dose
16121993|NCT01995617|Biological|GEN-004 Low Dose|The GEN-004 Low Dose contains 10µg of each of the three antigens.
16121994|NCT01995617|Biological|GEN-004 Low Dose + Adjuvant|The GEN-004 Low Dose contains 10µg of each of the three antigens in combination with 350µg of aluminum hydroxide adjuvant.
16121995|NCT01995617|Biological|GEN-004 Mid Dose|The GEN-004 Mid Dose contains 30µg of each of the three antigens.
16121996|NCT01995617|Biological|GEN-004 Mid Dose + Adjuvant|The GEN-004 Mid Dose contains 30µg of each of the three antigens in combination with 350µg of aluminum hydroxide adjuvant.
16121997|NCT01995617|Biological|GEN-004 High Dose|The GEN-004 High Dose contains 100µg of each of the three antigens.
16121998|NCT01995617|Biological|GEN-004 High Dose + Adjuvant|The GEN-004 High Dose contains 100µg of each of the three antigens in combination with 350µg of aluminum hydroxide adjuvant.
16121999|NCT01995604|Other|Application of Sterile 0.9% Saline Solution|Application of Sterile 0.9% Saline Solution to half of face after UltraPulse laser therapy.
16122000|NCT01995604|Other|Application of dHACM|Application of dHACM to half of face after UltraPulse laser therapy.
16122001|NCT01995578|Drug|low dose 5'-azacitidine|5'-azacitadine will be given at a low dose of 32mg/m2 S.C for 5 days every 28 days (a cycle). Dose de-escalation will be permitted for hematologic and non- hematologic toxicities. Patients will start taking the study drug between days 60-120 post TCD allogeneic hematopoietic stem cell transplant and up to a year post-transplant or until there is a toxicity that requires cessation of therapy. Therefore patients will get between 8-10 cycles. Patients who come off-study for reasons unrelated to toxicities before completing 4 cycles will be replaced Since most cases of relapse occur early post transplant, in the first year, this is the most appropriate time to intervene. Treatment will start as soon as possible.
16122002|NCT01995565|Other|PLR|
16122003|NCT01995552|Device|External Loop Recorder|
16122004|NCT01995539|Behavioral|therapy regimen|Subjects will be recommend changes in therapy regimens.
16122005|NCT01995526|Drug|Insulin Peglispro|
16122006|NCT01995513|Drug|Enzalutamide|160 mg by mouth once daily
16122007|NCT01995513|Drug|Abiraterone|1000 mg by mouth once daily
16122008|NCT01995513|Drug|Placebo for Enzalutamide|Sugar pill manufactured to mimic Enzalutamide 40 mg capsule
16122016|NCT01995461|Drug|bilateral transforaminal epidural steroid injections|BTESI with local anesthetic and steroid, and the use of x-ray contrast, under fluoroscopy guidance performed by the PI. 10mg of dexamethasone (1cc) mixed with 1cc of 2% preservative-free xylocaine (lidocaine) will be injected on each side of the stenotic segment under fluoroscopic guidance after confirming epidural x-ray contrast (1-2cc) spread right before the steroid mixed with local anesthetic injection. The injection may be repeated, but not before 2 weeks after the first injection.
16122017|NCT01995448|Biological|Blood test|Residue of blood further to NFS.
16122018|NCT01995435|Device|Telemedicine refraction|
16122019|NCT01995435|Device|Traditional refraction|
16122020|NCT01995422|Other|Physical activity program|One hour sessions of active walking occurring three times a week during three months
16122021|NCT01995409|Behavioral|No smoking material provided in households with newborn infants|
16122022|NCT01995396|Procedure|APE with intersphincteric dissection|Abdominal operation where the rectum is resected down to the levator and then the anus is resected by an intersphincteric dissection and order to leave the outer sfincter and levator in place to avoid a large wound and a high rate of infectious complications.
16122023|NCT01995396|Procedure|Hartmann´s procedure|Abdominal operation where the rectum is resected and stapled off distally and a stoma is created
16122024|NCT01995383|Other|LS followed by NS diet condition|LS diet period followed by NS diet period
16122025|NCT01995383|Other|NS followed by LS diet condition|NS diet period followed by LS diet period
16122026|NCT01995383|Drug|Placebo|Single oral administrations
16122027|NCT01995383|Drug|Placebo|2 single oral administrations
16122028|NCT01995383|Drug|RO6836191|Orally administered, single ascending doses
16122029|NCT01995383|Drug|RO6836191|2 single oral doses
16122030|NCT01995383|Drug|RO6836191|Intravenous administration
16122031|NCT01995370|Drug|aspirin|Aspirin (81mg or 100mg) will be orally administered once daily.The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.
16122032|NCT01995370|Drug|clopidogrel|Clopidogrel (50mg or 75mg) will be orally administered once daily.The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.
16122033|NCT01995370|Drug|cilostazol|Cilostazol (100mg twice daily) will be orally administered. The treatment period will begin with the first visit of the first subject and end one year after the first visit of the last subject.
16122034|NCT01995357|Device|Coloplast Test A|Coloplast Test A is a newly developed ostomy appliance
16122035|NCT01995357|Device|Coloplast Test B|Coloplast Test B is a newly developed ostomy appliance.
16122036|NCT01995357|Device|Standard product|Standard product is the subjects usual product. Only subjects that usually use the CE-marked commercially available SenSura 1-piece flat and SenSura Mio 1-piece are included in the investigation.
16122037|NCT01995344|Drug|Cyclophosphamide|
16122038|NCT01995344|Drug|Fludarabine|
16122039|NCT01995344|Genetic|Tumour Infiltrating Lymphocytes|
16122040|NCT01995344|Drug|Interleukin-2|
16122041|NCT01995331|Drug|cyclophosphamide,cyclosporine A|"Drug,cyclophosphamide,cyclophosphamide (30 mg/kg/day) administered intravenously (IV) over 1 hr for 4 consecutive days Drug,cyclosporine A,5mg-12mg/kg.d,CSA was administered orally 40 days after the fourth dose of cyclophosphamide and maintained for 3 years. The dose of CSA was adjusted to maintain trough drug concentration above 150 μg/L and peak drug concentration above 300 μg/L.
~Drug, human granulocyte colony-stimulating factor (rhG-CSF), 5 μg/kg/day subcutaneously starting 24 hrs after the fourth dose of cyclophosphamide, and it was withdrawed when ANC was >1×109/L."
16122042|NCT01995318|Other|Kinesiotaping|Application of anti-edema type kinesiotaping to injured ankle.
16122043|NCT01995305|Genetic|human whole exome|he exome is the part of the genome formed by exons, coding portions of genes in the genome that are used in the synthesis of proteins, therefore, it is most likely to contribute to the phenotype of an organism. The exome of the human genome, is estimated to comprise 1.5% of the total genome (The human exome is about 30 MB).
16122044|NCT01995305|Genetic|whole genomic|This study propose to find the genes that are sensitive to DNA crosslink repair, and genes that have key roles in hematopoietic cell development and maturation.
16122045|NCT01995292|Device|bronchoscope|
16122046|NCT01995292|Device|Enk Fiberoptic Atomizer|
16122047|NCT01995279|Device|French ear acupuncture|Single session (20 minutes) of French ear acupuncture at specific location used to reduce low back pain.
16122048|NCT01995279|Other|Sham Ultrasound|Ultrasound turned off.
16122049|NCT01995266|Drug|Asunaprevir|
16122050|NCT01995266|Drug|Daclatasvir|
16122051|NCT01995253|Device|Energy expenditure estimation in controlled conditions|Volunteers were asked to perform several activities such as walking at different paces, running, sitting, standing still or taking public transportation for about 3h30 They wore 2 research sensors that estimate energy expenditure: Armband and Actiheart. They also wore a smartphone (in a front pant pocket) that collected accelerometry data.
16122052|NCT01995253|Device|Energy expenditure estimation in free-living conditions|Volunteers were asked to wear sensors during about 12 hours, one day. They wore 2 research sensors that estimate energy expenditure: Armband and Actiheart. They also wore a smartphone (in a front pant pocket) that collected accelerometry data.
16122053|NCT01995240|Drug|Gadobutrol|0.1 ml/kg Gadovist is administered at 5 ml/s followed by a 15 ml saline flush
16122054|NCT01995227|Biological|AlloVax|Personalized anti-cancer vaccine
16122055|NCT01995227|Biological|CRCL|Personalized anti-cancer vaccine
16122056|NCT01995227|Biological|AlloStim|ID injections IV infusion
16122057|NCT01995214|Drug|Propofol|Anesthesia maintenance with propofol+remifentanil guided by Narcotrend index monitoring.
16122058|NCT01995214|Drug|Sevoflurane|Anesthesia maintenance with sevoflurane+remifentanil guided by Narcrotrend index monitoring.
16122059|NCT01995201|Drug|DMARD|non-biological disease-modifying antirheumatic drugs at stable dose
16122060|NCT01995201|Drug|methotrexate|stable dose
16122061|NCT01995201|Drug|tocilizumab [RoActemra/Actemra]|162 mg subcutaneously (SC) qw, Weeks 1-24
16122062|NCT01995201|Drug|tocilizumab [RoActemra/Actemra]|162 mg SC qw or q2w, Weeks 24-48
16122063|NCT01995201|Drug|tocilizumab [RoActemra/Actemra]|162 mg SC qw, Weeks 24-48
16122066|NCT01995188|Drug|DNIB0600A|DNIB0600A at an initial dose of 1.2 mg/kg will be administered via IV infusion further following a dose-escalation until DLT under consultation of the investigator on Day 1 of 21 day dose-escalation cycle. RP2D will be administered further in dose-expansion for until disease progression or death, whichever occurs first.
16122070|NCT01995162|Device|Energy expenditure estimation|Volunteers were asked to wear sensors during about 12 hours, one day. They wore 2 research sensors that estimate energy expenditure: Armband and Actiheart. They also wore a smartphone (in a front pant pocket) that collected accelerometry data.
16122071|NCT01995149|Behavioral|Weight loss and dietary intervention|The weight loss intervention had a total duration of 6 months. Each participant's caloric prescription represented a deficit of 600 kcal per day as calculated from the person's resting energy expenditure and activity level using the Harris-Benedict equation. In general, prescribed energy intake was between 1200 kcal and 1600 kcal/day. Dietary composition consisted on 50-55% of carbohydrates, 15-20% of protein and 30% of fat and included a wide variety of foods typical of a Mediterranean diet. Patients were also provided with recipes and shopping counselling to improve intervention compliance and to achieve the weight loss goal. Individual consultations with a nutritionist were performed twice a month to motivate the weight loss and reinforce the intervention.
16122072|NCT01995136|Drug|Travoprost Ophthalmic Solution 0.004%|benzalkonium chloride (BAC) free
16122073|NCT01995123|Behavioral|Behavioral Activation Therapy|Behavioral Activation (BA) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. BA treatment will focus on encouraging subjects to participate in activities that they find enjoyable and rewarding.
16122074|NCT01995123|Behavioral|Health and Smoking Education|Health and Smoking Education (HSE) Treatment will be delivered in eight, 30 minute individual sessions over an 8-week period. HSE treatment will focus on smoking, health, and the impact of smoking on the subject's health.
16122075|NCT01995123|Behavioral|Standard Smoking Cessation Therapy|Standard smoking cessation therapy will be delivered in eight, 20-minute individual sessions over an 8-week period.
16122076|NCT01995110|Other|high-fat meal A|
16122077|NCT01995110|Other|high-fat meal B|
16122078|NCT01995110|Other|high-fat meal C|
16122079|NCT01995097|Behavioral|Scheduled Gradual Reduction Text Messages|
16122080|NCT01995097|Behavioral|Support Text Messages|
16122081|NCT01995084|Drug|[F-18]HX4|400 MBq [F-18]HX4, is administered in a single intravenous bolus injection, followed by a saline flush.
16122082|NCT01995071|Drug|ABT-493|Tablet
16122083|NCT01995071|Drug|ABT-530|Tablet
16122084|NCT01995071|Drug|ABT-450/r/ABT-267, ABT-333|Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
16122085|NCT01995071|Drug|Ribavirin (RBV)|Tablet
16122086|NCT01995058|Drug|cabozantinib|Tablets taken orally
16122087|NCT01995058|Drug|abiraterone|Tablets taken orally daily
16122088|NCT01995058|Drug|prednisone|Tablets taken orally twice daily
16122089|NCT01995045|Drug|Triamcinolone|Retrobulbar anesthesia
16122090|NCT01995045|Drug|Bupivicaine Hydrochloride|Retrobulbar anesthesia
16122091|NCT01995032|Drug|750 mg metformin and 7.5 g L-citrulline daily p.o.|
16122092|NCT01995032|Drug|Placebo|
16122093|NCT01995019|Drug|Methylprednisolone|1 ml single dose Intra-articular Depo-Medrol 40 mg/ml
16122094|NCT01995019|Drug|Physiologic saline|1 ml intra-articular placebo
16122095|NCT01995006|Drug|metamizole|metamizol tablets (500mg): 1000mg TID during 7 days
16122096|NCT01995006|Drug|Naproxen|Naproxen tablets (500mg): 500 mg BID during 7 days
16122097|NCT01994993|Drug|ampicillin and metronidazole and gentamicin|IV infusion of ampicillin and metronidazole and gentamicin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
16122098|NCT01994993|Drug|ampicillin and gentamicin and clindamycin|IV infusion of ampicillin and gentamicin and clindamycin for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
16122099|NCT01994993|Drug|gentamicin and Piperacillin- tazobactam|IV infusion of gentamicin and Piperacillin- tazobactam for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
16122100|NCT01994993|Drug|standard of care antibiotics and metronidazole|IV infusion of standard of care antibiotics and metronidazole for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
16122101|NCT01994993|Drug|metronidazole, clindamycin, or piperacillin-tazobactam|IV infusion of metronidazole, clindamycin, or piperacillin-tazobactam with scheduled CSF procedures per standard of care. Study drug will be given for for a total of 10 days. Dose based on postnatal age (PNA) and gestational age(GA)
16122102|NCT01994980|Drug|Default 4 days antibiotic therapy|The intervention for this trial involves a shorter duration of antibiotic therapy. Specifically, a default of 4 vs. 8 days.
16122103|NCT01994967|Drug|Levobupivacaine|Will be administered 3 ml of the investigational anesthetic in combination with morphine through the subarachnoid via.
16122104|NCT01994967|Drug|Bupivacaine|Will be administered 3 ml of the investigational anesthetic in combination with morphine through the subarachnoid via.
16122105|NCT01994954|Other|RHO|Recorded oximetry data will be downloaded from home oximeters, analyzed, and used to assist in supplemental oxygen weaning decisions.
16122106|NCT01994941|Drug|Clopidogrel|"A platelet aggregation inhibitor. Also a P2Y12 Receptor Blocker of a drug class Thienopyridine.
~Increasing evidence has shown that clopidogrel has wide inter-individual variability in pharmacokinetic and pharmacodynamic actions which lead to suboptimal antiplatelet effect especially in Asian population.
~A standard loading dose of 300mg or 600mg(according to clinical protocol) will be given to patients."
16122107|NCT01994941|Drug|Ticagrelor|"A platelet aggregation inhibitor.
~Though this agent has better anti-ischemic effects, it is associated with increased bleeding risk especially in Chinese patients whom are considered to be more prone to bleeding complications.
~A loading dose of 180mg will be used."
16122111|NCT01994915|Other|Occupational therapy|Patients included in this group are going to receive an occupational therapy intervention 3 sessions after hospital discharge. The intervention is based on energy conservation techniques improving the execution of the activities of daily living.
16122112|NCT01994902|Device|Coloplast test product|The Coloplast test product is a newly developed ostomy appliance
16122113|NCT01994902|Device|SenSura Convex Light|The comparator product is SenSura Convex Light, which is CE-marked and commercially available.
16122114|NCT01994889|Drug|Tafamidis|Tafamidis 20 mg in soft gel capsules administered once a day for 30 months
16122115|NCT01994889|Drug|Tafamidis|Tafamidis 80 mg in soft gel capsules administered once a day for 30 months
16122116|NCT01994889|Drug|Placebo|Placebo in soft gel capsules administered once a day for 30 months
16122117|NCT01994876|Device|Coloplast Test 1|Coloplast Test 1 is a newly developed 1-piece convex ostomy appliance
16122118|NCT01994876|Device|Coloplast Test 2|Coloplast Test 2 is a newly developed 1-piece convex ostomy appliance
16122119|NCT01994863|Device|Coloplast Test product|Coloplast test product is a newly developed 1-piece ostomy appliance
16122120|NCT01994863|Device|Standard Care|"Standard care consists of three already marketed 1-piece ostomy products
~Coloplast SenSura Hollister Moderma/Moderma Flex B.Braun Flexima/Softima"
16122121|NCT01994850|Drug|brentuximab vedotin|Trade name: Adcetris
16122122|NCT01994837|Drug|ABT-199|Tablet
16122123|NCT01994824|Drug|rabbit antithymocyte globulin|Thymoglobulin, 3 mg/kg, will be given on day 8 posttransplant to patients at high risk of significant GVHD per day 7 IL15 and IL2Ra levels.
16122124|NCT01994785|Diagnostic Test|Capnographic Monitoring|Capnographic Monitoring: Patients will undergo procedures with real-time capnographic monitoring
16122125|NCT01994772|Procedure|Targeted controlled temperature between 32.5 and 33.5°C|Therapeutic hypothermia ie targeted controlled temperature between 32.5° and 33.5°C will be induced in the active group. Usual method of controlled temperature will be use in ICU: internal active method or external active method.
16122126|NCT01994772|Procedure|Targeted controlled temperature between 36.5 and 37.5°C|Temperature was maintain between 36.5° and 37.5°C in the control group. In case of temperature superior to 37.5°C or inferior to 36.5°C, a pharmaceutical treatment and/or active cooling or warming was introduce to maintain temperature between the range of 36.5 - 37.5°C.
16122127|NCT01994759|Other|Training|Patients are instructed to carry out strengthening exercises for the fascia plantaris 3 days a week and stretching exercises every day. Four times in the first 2 months supervised training in groups is carried out with a physiotherapist supervising the exercises and instructing in progression and new exercises, and all participants are instructed to carry out a specific training program daily at home. The amount of training performed by each patient, is registered in a diary weekly
16122128|NCT01994759|Drug|Glucocorticosteroid injection|"Ultra sound guided injection af 1 ml og Glucocorticosteroid (methylprednisolone 40 mg) and 1 ml of lidocaine 5mg/ml from the medial side profound to the thickened part of the fascia plantaris.
~Glucocorticosteroid injections are given every month until the aponeurosis thickness is less than 4 mm as determined by ultrasonography (max 3 injections)."
16122129|NCT01994759|Behavioral|Reduction in impact|advocate reduction in standing, walking, running, jumping. advocate shock absorbing shoes advocate prefabricated insoles advocate taping in special occasions.
16122130|NCT01994746|Drug|Nasal Glucagon|
16122131|NCT01994746|Drug|Intramuscular Glucagon|
16122132|NCT01994733|Drug|Calcium carbonate ( Intensive phosphate control)|Individuals randomized to this arm will be exposed to a treatment strategy that targets a P of < 1.50 mmol/L, reflecting the recommendations of current guidelines. Titration of the calcium carbonate dose will be the core of this approach and this will be complemented by usual recommendations regarding dietary P restriction. Dietitians will be available to provide counseling with regards to any aspect of the end-stage renal disease diet, as per usual dialysis unit practice
16122133|NCT01994733|Drug|Calcium carbonate (Liberalized phosphate control)|"Individuals in this arm will be exposed to a treatment strategy that allows P to rise above 2.00 mmol/L. This will be accomplished through structured reduction of P binders already in use (as per the algorithm detailed below). Rescue P binding will be instituted if P rises above 2.50 mmol/L. Dietitians will be available to provide counseling regarding any aspect of the end-stage renal disease diet, as per usual dialysis unit practice, but will not provide counseling on dietary P restriction unless the P rises above 2.50 mmol/L."
16122134|NCT01994720|Drug|ticagrelor|ticagrelor, 180 mg (two tablets of 90 mg) loading dose on Day 1 followed by 90 mg twice daily.
16122135|NCT01994720|Drug|Acetylsalicylic acid (ASA)|ASA, 300 mg (three tablets of 100 mg) on Day 1, followed by 100 mg once daily.
16122136|NCT01994707|Procedure|Remote ischemic preconditioning|Blood pressure cuff inflation
16122137|NCT01994707|Procedure|Placebo|Deflated cuff on arm for 30 minutes.
16122138|NCT01994668|Drug|Lorazepam|A single intravenous administration of 2 mg lorazepam over 1 minute
16122139|NCT01994668|Drug|Placebo|A single intravenous administration of 0.9% saline over 1 minute
16122140|NCT01994655|Other|Doing exercise|We want to investigate the effects of exercise on climacteric symptoms
16122141|NCT01994655|Other|Doing exercise|Doing exercise at least 6 months including walking, running, yoga etc.
16122142|NCT01994642|Drug|Ciprofloxacin 0.3%/dexamethasone 0.1% sterile otic suspension|
16122143|NCT01994642|Drug|CIPRODEX® (ciprofloxacin 0.3%/dexamethasone 0.1%)|
16122144|NCT01994642|Drug|Placebo Sterile Otic Suspension|
16122145|NCT01994629|Biological|MenACWY-CRM|MenACWY-CRM
16122146|NCT01994629|Biological|MenACWY-TT|MenACWY-TT
16122147|NCT01994616|Procedure|Intralesional cryotherapy|Intralesional (IL) cryotherapy is a treatment for keloids and hypertrophic scars, in which the scar is frozen from inside with the use of a cryoneedle
16122148|NCT01994603|Behavioral|Opt-in or Opt-out testing|Study participants will be offered a health screening onsite.
16122149|NCT01994603|Behavioral|Focus Group|Study participants will be invited to participate in a focus group discussion.
16122150|NCT01994590|Drug|Dovitinib|Starting dose will be 400 mg by mouth daily on Days 1-5, 8-12, 15-19, and 22-26 of each 28 day cycle.
16122151|NCT01994590|Drug|Abiraterone Acetate|4 tablets (250 mg each) by mouth daily.
16122152|NCT01994590|Drug|Prednisone|5 mg by mouth twice daily.
16122153|NCT01994538|Other|Longer therapy duration|14 days of antimicrobial treatment
16122154|NCT01994538|Other|Shorter therapy duration|7 days of antimicrobial treatment
16122155|NCT01994525|Biological|PfRAS|Radiation-attenuated Plasmodium falciparum sporozoites (PfRAS) administered by the bite of infected Anopheles stephensi mosquitoes
16122156|NCT01994525|Biological|Placebo|Administered by the bite of noninfected Anopheles stephensi mosquitoes
16122157|NCT01994525|Other|Challenge|5 infectious Anopheles stephensi mosquito bites carrying infectious Plasmodium falciparum sporozoites within a controlled clinical environment.
16122158|NCT01994512|Procedure|Decompression without fusion|Decompressive surgery of both central and lateral component of the stenosis.
16122159|NCT01994512|Procedure|Decompression with fusion|Decompressive surgery of both central and lateral component of the stenosis AND concomitant instrumented or uninstrumented posterior fusion of decompressed segments.
16122160|NCT01994499|Device|Videothoracoscopy drainage|videothoracoscopy drainage of pleural effusion
16122161|NCT01994499|Drug|Medical drainage|Medical pleural drainage
16122162|NCT01994486|Drug|Telaprevir and Sofosbuvir|All subjects will have time to read and discuss IRB approved consent form prior to any study procedures. Following proper consenting, subjects will undergo physical exam including ECG and bloodwork prior to baseline visit. Subjects will return for research visits (vitals, collection of AEs, bloodwork, drug accountability) on Day 3, Weeks 1, 2, 3, 4, 6, 8, 10 and 12 of treatment and 4, 12, and 24 weeks after end of treatment. PK samples will be collected at week 2 and week 10.
16122163|NCT01994473|Drug|SEP-363856|SEP-36385625 as a single oral dose of 10, 25, 50, and 100 mcg
16122164|NCT01994473|Drug|Placebo|single oral dose placebo
16122165|NCT01994473|Drug|SEP-363856 Open Label|75 mg SEP-363856 given once-daily
16122166|NCT01994460|Drug|Linezolid|
16122167|NCT01994460|Drug|Ethambutol|
16122168|NCT01994447|Other|Student Enrollment|The standard informed consent process is for research nurses to provide verbal explanations of studies. In the intervention arm trained research students will use DVD's made by the studies principal investigator to explain study information in the informed consent process.
16122169|NCT01994434|Procedure|Decompression of the ulnar nerve|Surgical decompression of the Guyon's canal and ganglion excision
16122170|NCT01994421|Other|Kinesiotape|
16122171|NCT01994408|Other|default intensification|The investigators will determine which blood pressure medications to use. No specific drug will be tested but rather the automatic intensification of medications is the intervention. Examples of drugs used in this study are calcium channel blockers (e.g., amlodipine 2.5 mg to 10 mg) or ACE-inhibitors (e.g., lisinopril 5 mg to 40 mg) or diuretics (HCTZ 25 mg).
16122172|NCT01994395|Device|The Stride Management Assist (SMA) System|Participants will participate in 18 sessions of outpatient physical therapy + 3 sessions of testing for up to 8 weeks. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait. Treatment consists of 30 minutes high intensity gait training with device, 15 minutes functional mobility with device.
16122173|NCT01994395|Other|Impairment based therapy|Participants participate in 18 weeks of outpatient physical therapy + 3 assessment sessions. Assessment (strength, flexibility, balance, sensation, endurance, transfers, gait). Treatment will be divided into: 15 min balance training, 15 minutes functional mobility (transfers, strength or flexibility training) and 15 min high intensity gait training
16122174|NCT01994382|Drug|Cerdulatinib (PRT062070)|
16122175|NCT01994369|Drug|EC17|
16122176|NCT01994356|Behavioral|Physician self-disclosure of personal IUC use|Physicians self-disclosed personal intrauterine contraceptive use to subjects in intervention arm of study during contraceptive counseling
16122177|NCT01994356|Behavioral|Usual contraceptive counseling|all subjects recieved usual contraceptive counseling
16122178|NCT01994343|Other|Global posture reeducation|An assessment of the women is performed using global posture reeducation.
16122179|NCT01994330|Drug|desmopressin|0.3 mcg per kilogram administered in 30 minutes a half hour previous to surgical incision
16122180|NCT01994317|Other|Algorithm|IV sedation dosing calculated by algorithm
16122181|NCT01994317|Other|Standard care|IV sedation dosing calculated by standard care.
16122182|NCT01994304|Behavioral|SCC|The intervention involves introducing and orienting health providers on the SCC, facilitating availability of a specific set of commodities and regular targeted supervision. These are expected to improve adherence to life saving interventions immediately before, during and after birth, and reduce intrapartum mortality (still births and very early neonatal deaths).
16122183|NCT01994291|Drug|Ranibizumab|"Intravitreal Injection supplied as:
~10 mg/mL in a 0.2 mL vial with instructions on preparation and administration of the 0.5 mg (0.05 mL) dose.
~6 mg/mL in a single use vial with instructions on preparation and administration of the 0.3 mg (0.05 mL) dose.
~Adminstered once a month for 12 weeks"
16122184|NCT01994291|Drug|Placebo|"Oral Placebo is provided in tablet form to match the 50mg dose of PF-04634817.
~Dose is 4 tablets each day for 12 weeks"
16122185|NCT01994291|Drug|PF-04634817|Four 50mg tablets PF-04634817 once a day for 12 weeks.
16122186|NCT01994291|Drug|Masked Sham Therapy|Empty, needle-less syringe is used by the unmasked team once a month.
16122187|NCT01994278|Device|Peri Clean|
16122188|NCT01994265|Drug|Warfarin|Warfarin once daily, at fast, targeting INR between 2 and 3
16122189|NCT01994265|Drug|Dabigatran|
16122190|NCT01994252|Device|Optimal Medical therapy plus ICD|
16122191|NCT01994252|Device|Optimal Medical therapy plus CRT/ICD|
16122192|NCT01994239|Drug|Degarelix|First dose of 240 mg 5 Maintenance doses of 80 mg every 28 days(+/-3d)
16122193|NCT01994239|Radiation|Pelvic Radiotherapy|46 Gy in 23 fractions Prostate only-boost up to 66 Gy
16122194|NCT01994226|Drug|Low-dose colchicine|"Route of Administration: Tablet - Oral Use
~Dose: 500 mcg (one tablet) every eight hours for four days"
16122195|NCT01994226|Drug|Naproxen 750 mg/250 mg|"Route of Administration: Tablet - Oral Use
~Dose: Single initial dose of 750 mg (three tablets) followed by 250 mg (one tablet) every eight hours for up to seven days"
16122196|NCT01994213|Drug|Famitinib|Famitinib 25 mg p.o. qd
16122230|NCT01993875|Drug|Placebo|Matching liquid placebo, 0 mcg x 2 pumps administered orally twice daily (BID)
16122231|NCT01993862|Other|Same Day Discharge|Patients will send device data remotely to their physician on the day of discharge from the hospital and again 24 hours after discharge from the hospital.
16122541|NCT01991743|Drug|Group 5|Administration of 5 mg bupivacaine
16122197|NCT01994200|Other|Interdisciplinary Team-Based Approach|Three meetings will be scheduled with the oncology dedicated-nurse. First meeting: information about the physical illness; the emotional impact of being newly diagnosed with thyroid cancer; as well as surgery and its' short- and long-term consequences. Second meeting: information on radioactive iodine treatments and its associated safety precautions, nutrition and dietary considerations. Third meeting: how the cancer diagnosis can be an opportunity to make important lifestyle changes and establish new life-priorities. The dedicated nurse, in collaboration with the Department of Nursing and ENT, will develop and implement an interdisciplinary team-based approached developed for this study according to guidelines of the Programme québécois de lutte contre le cancer (PQLC).
16122198|NCT01994200|Other|Usual Care Control|Patients in the control group will be provided with usual care, comprised of meetings with surgeons and endocrinologists. All patients in this study will be provided with an information website containing information on their cancer, treatments, and treatment side-effects.
16122199|NCT01994187|Procedure|Carotid endarterectomy|
16122200|NCT01994187|Procedure|carotid angioplasty|
16122201|NCT01994161|Procedure|intracranial stenting|"all the participants in this group will be performed with intracranial stenting
~--------------------------------------------------------------------------------"
16122202|NCT01994148|Procedure|Laparoscopy|In this study, laparoscopic intervention will be performed under carbon dioxide pneumoperitoneum (pressure, 10-12 mm Hg; flow volume, 8-10 L/min). A 12-mm trocar will be placed in the umbilicus with use of an open technique and to establish pneumoperitoneum.A 10-mm and a 5-mm trocar will be inserted in the right and left flanks,respectively.
16122203|NCT01994135|Other|Reference food|Reference food will be used to which test food samples will be compared to.
16122204|NCT01994135|Other|Test food dose 1|Will contain low dose of a mixture of polyphenols in addition to the reference food
16122205|NCT01994135|Other|Test food dose 2|Will contain high dose (twice of the low dose) of a mixture of polyphenols in addition to the reference food
16122206|NCT01994109|Drug|MYOBLOC|"MYOBLOC (rimabotulinumtoxinB) Injection, or botulinum toxin type B, is the B serotype of botulinum toxin. It is the only commercially available B serotype, and also the only available botulinum toxin that does not require reconstitution for use."
16122207|NCT01994109|Other|PLACEBO|
16122208|NCT01994096|Drug|Caspofungin|
16122209|NCT01994083|Drug|Placebo|Administered orally
16122210|NCT01994083|Drug|IX-01|Administered orally
16122211|NCT01994070|Drug|Electrical-first|Patients will be placed on cardiopulmonary blood pressure monitoring, and sedated with propofol 0.5 - 1.0 mg / kg. Once a Ramsay Sedation Scale score of 5 or greater is reached, the physician will attempt synchronized electrical cardioversion with 100 J, 200 J, 200 J. If the patient converts to normal sinus rhythm by the third shock, the physician may discharge the patient. If atrial fibrillation is maintained, the patient will receive intravenous procainamide 17 mg / kg over 30 minutes. If the rhythm has changed from atrial fibrillation to normal sinus within one hour, the attending physician may discharge the patient, otherwise a cardiologist will be consulted.
16122212|NCT01994070|Drug|Chemical-first|Patients will be placed on cardiopulmonary blood pressure monitoring, and will receive intravenous procainamide 17 mg / kg over 30 minutes. If the rhythm has changed from atrial fibrillation to normal sinus within one hour, the attending physician may discharge the patient. If the rhythm has not changed, then the patient will be continue to have cardiopulmonary monitoring, but also be attended by a respiratory therapist. The patient will be sedated with propofol 0.5 - 1.0 mg / kg. Once a Ramsay Sedation Scale score of 5 or greater is reached, the physician will attempt synchronized electrical cardioversion with 100 J, 200 J, 200 J. If the patient converts to normal sinus rhythm by the third shock, the physician may discharge the patient, otherwise a cardiologist will be consulted.
16122213|NCT01994044|Procedure|Cervical fusion|
16122214|NCT01994031|Drug|Paclitaxel liposome injection|
16122215|NCT01994031|Drug|Paclitaxel injection|
16122216|NCT01994005|Behavioral|Facebook|Facebook page with contraception information used for counseling
16122217|NCT01994005|Behavioral|Pamphlet|Contraceptive knowledge pamphlets
16122218|NCT01993979|Drug|Chemotherapy|
16122219|NCT01993979|Other|Surveillance|Patients will be closely monitored for early signs of recurrence, for which they will receive treatment as decided in discussion between the clinician and patient. This may include chemotherapy.
16122220|NCT01993953|Other|BodyPump|Participants will be offered BP sessions at fitness centers in Oslo/Akershus. They will exercise three times a week. The instructors at all centers have a BP license from Les Mills, and the same program will be conducted at all centers at all times. The project manager has been in contact with Les Mills Scandinavia and has been given permission to use the training concept for research.
16122221|NCT01993953|Other|Personal training|Participants in this group will be offered training with a PT at the Norwegian School of Sports Sciences. They will exercise with their PT three times per week. The training program for this group will be based on the exercises in the BP class, but repetitions will vary between 3-15, and series between 2-4.
16122222|NCT01993953|Other|Resistance training with instructor|Participants in this group will be invited to train on their own, three times a week, at the Norwegian School of Sports Science. Prior to the intervention period they will receive a training manual, instructions of the exercises and advice about progression during the intervention period. They will also have a follow-up with the same instructor after six weeks. The training program for this group will be the same as for group B. The PT's from group B will also serve as training instructors.
16122223|NCT01993940|Drug|Naldemedine|Naldemedine 0.2 mg tablet taken orally once a day
16122224|NCT01993940|Drug|Placebo|Placebo tablet taken orally once a day
16122225|NCT01993927|Drug|Voglibose|Voglibose Tablets / Voglibose OD Tablets
16122226|NCT01993901|Other|CSRT led telephone follow up|Patients in the intervention group will be telephoned by the CSRT 4-6 weeks after completion of their treatment to assess any symptoms. A second follow up telephone call will be made at 12 weeks post treatment if required in order to address treatment related side effects that were identified during the first call and any interventions that were recommended
16122227|NCT01993888|Biological|EVARREST® Fibrin Sealant Patch|
16122228|NCT01993888|Other|Standard of Care (SoC)|
16122229|NCT01993875|Drug|Lubiprostone|Liquid formulation, 12 mcg x 2 pumps administered orally twice daily (BID)
16122279|NCT01993589|Drug|comparison of pain relievers during curattage|
16122232|NCT01993849|Drug|N-Acetylcysteine (NAC)|This is the medication N-acetylcysteine (NAC)
16122233|NCT01993849|Other|Placebo|Placebo, designed to match in appearance to NAC
16122234|NCT01993836|Drug|Total intravenous anesthesia with propofol|
16122235|NCT01993836|Drug|General anesthesia with isoflurane|
16122236|NCT01993823|Drug|G238|Five drops into the ear canal twice daily for 14 days
16122237|NCT01993823|Drug|Clotrimazole|Five drops into the ear canal twice daily for 14 days
16122238|NCT01993810|Drug|Carboplatin|Given IV
16122239|NCT01993810|Drug|Cisplatin|Given IV
16122240|NCT01993810|Biological|Durvalumab|Given IV
16122241|NCT01993810|Drug|Etoposide|Given IV
16122242|NCT01993810|Drug|Paclitaxel|Given IV
16122243|NCT01993810|Drug|Pemetrexed Disodium|Given IV
16122244|NCT01993810|Radiation|Photon Beam Radiation Therapy|Undergo photon beam radiation therapy
16122245|NCT01993810|Radiation|Proton Beam Radiation Therapy|Undergo proton beam radiation therapy
16122246|NCT01993810|Other|Quality-of-Life Assessment|Ancillary studies
16122247|NCT01993810|Other|Questionnaire Administration|Ancillary studies
16122248|NCT01993797|Other|Lung US|
16122249|NCT01993784|Drug|nimotuzumab|
16122250|NCT01993771|Procedure|Surgery with general anaesthesia.|
16122251|NCT01993771|Procedure|Raw EEG|
16122252|NCT01993758|Procedure|Low tourniquet pressure|Tourniquet pressure set as 120mmHg above the systolic blood pressure just before tourniquet inflation
16122253|NCT01993758|Procedure|Conventional tourniquet pressure|Tourniquet pressure set as 150mmHg above the systolic blood pressure just before tourniquet inflation
16122254|NCT01993732|Procedure|Retrieval and Cryopreservation|Females undergoing therapeutic procedures that will potentially lead to the irreversible loss of ovarian function will have their ovarian tissue retrieved and cryopreserved. Ideally, after treatment, the cryopreserved ovarian tissue can be thawed and auto-transplanted and ovarian function resumed.
16122260|NCT01993706|Drug|VRC-HIVMAB060-00-AB|
16122261|NCT01993693|Device|Ultrasonic Diathermy Device|The Ultrasonic Diathermy Device provides low intensity therapeutic ultrasound to musculoskeletal tissues and joints for the purpose of pain relief, relief of muscle spasm, treatment of joint contraction, and local increase of circulation. The device is FDA-cleared for up to 4 hours of continuous use per treatment. It is a stationary hands-free device.
16122262|NCT01993693|Device|Sham Ultrasonic Diathermy Device|Sham therapy delivered by Ultrasonic Diathermy Device that appears identical to active device but does not deliver ultrasound
16122263|NCT01993680|Drug|Pyridostigmine bromide|"Drug doses during the trial:
~Pyridostigmine bromide: 30mg p.o. 1-1-1 to 2-2-2 given for 14 days"
16122264|NCT01993680|Drug|fludrocortisone|drug dose during the trial Fludrocortisone: 0,1mg p.o. 1-0-0 to 2-0-0 given for 14 days
16122265|NCT01993667|Drug|Low Dose Acetazolamide|Administration of low dose acetazolamide
16122266|NCT01993667|Drug|Normal Dose Acetazolamide|Administration of normal dose acetazolamide
16122267|NCT01993654|Procedure|HRT III with Non-Contact Cornea Rostock Module|Confocal imaging of the conjunctival lesion
16122268|NCT01993641|Drug|pracinostat|Histone deacetylase inhibitor (HDACi) Pracinostat is to be taken before HMA administration 3 times/week (e.g., Monday, Wednesday, and Friday) for 3 weeks, followed by 1 week of rest as a 28-day cycle. Pracinostat administration will be at the clinic on Day 1 of Cycles 1 and 2 and subject will self-administer at home on all other days
16122269|NCT01993641|Drug|Azacitidine|All patients will receive the dose and schedule of azacitadine to which they previously failed to respond. (e.g. 75 mg/m2 via subcutaneous (SC) injection or intravenous infusion if SC injections are intolerable; 7 days of each 28 day cycle, either Days 1-7, or Days 1-5, rest on Days 6-7, and azacitadine dosing on Days 8-9)
16122270|NCT01993641|Drug|Decitabine|"All patients will receive the dose and schedule of decitabine to which they previously failed to respond. Common 28 day treatment regimens include: 20 mg/m2 IV for either 5 or 10 days of each 28-day cycle, 10 mg/m2 given intravenously daily for first 10 days of each 28 day cycle, or 20 mg/m2 given subcutaneously daily for the first 5 days of each 28 day cycle.
~The 6-week regimen utilizes a dose of 15 mg/m2 by continuous intravenous infusion over 3 hours repeated every 8 hours for 3 days repeated every 6 weeks."
16122271|NCT01993628|Other|Rey figure test|
16122272|NCT01993628|Other|MRI|
16122273|NCT01993615|Procedure|Arthroscopic Surgery|The hip arthroscopy will consist of acetabular rim trimming, labral repair or debridement and femoroplasty, all as indicated based on the surgeon's clinical judgment with input from pre-operative imaging, exam findings and intra-operative findings.
16122274|NCT01993615|Procedure|Physical Therapy|Subjects will participate in two 45-minute sessions for six weeks (total of 12 sessions). The physical therapy treatment plan will be based on individual impairments identified during the initial evaluation, and include manual therapy to the hip, lumbar spine, and pelvis, as well as therapeutic exercise all tailored to individual patient impairments.
16122275|NCT01993602|Procedure|Breathing exercises|"The intervention groups (CPAP, VIS, FIS and DB) used the specific device (or not) according to the group allocation.
~The intervention was performed 3 times per day, from 1 to 5 postoperative day. Patients performed 5 sets of 10 repetitions of the specific breathing exercise, with 30 seconds rest between each set.
~The sessions were held in the morning, early afternoon and early evening, always supervised by a physiotherapist.
~Before starting each session, the patient reported the sensation of pain, and if he quantify pain intensity more than 3 in the visual numeric scale (0 to 10) was asked the doctor to administer analgesics aiming that him to perform properly the breathing exercise."
16122276|NCT01993589|Drug|comparison of pain relievers during curattage|
16122277|NCT01993589|Drug|comparison of pain relievers|
16122278|NCT01993589|Drug|comparison of pain relievers during curattage|
16122281|NCT01993576|Drug|Indocyanine Green|Intravenous injection of 0.25 mg/kg Indocyanine Green (ICG) before the surgery
16122282|NCT01993563|Other|Graded Motor Imagery|"GMI program includes three steps: Implicit Motor Imagery (IMI); Explicit Motor Imagery (EMI) and Mirror Box Therapy (MT).
~IMI included a training based on Hand Laterality Discrimination Tasks. During these tasks 60 pictures of right and left hands are projected randomly on a 15 screen. Patients are asked to choose whether the images seen are right or left and therefore to click respectively the right or the left button on a mouse.
~EMI training consists in imagining a movement without actual performing it. It will be introduced during IMI's last two sessions and gradually enhanced increasing the complexity of motor skills to be imagined. The therapist shows or explains in details the movements the patient have to mentally rehearsed.
~MT treatments will start with simply watching the unaffected hand in the mirror and increased toward functional movement. When possible, gentle movement with the affected hand will be encouraged behind the reflecting part of the mirror."
16122283|NCT01993563|Other|Standard treatment|Patients will undergo to a standard treatment, that is thought to be the best option for that specific patients. In our hospital, treatment options include: motor training, functional training, occupational therapy, bilateral arm training or motor treatment using virtual reality devices.
16122284|NCT01993550|Behavioral|Telephone counseling|
16122285|NCT01993550|Behavioral|Education|
16122286|NCT01993537|Drug|Vitamin D|
16122287|NCT01993524|Dietary Supplement|probiotic|antibiotic plus probiotic
16122288|NCT01993524|Other|placebo|antibiotic plus placebo
16122289|NCT01993498|Procedure|blood sampling|blood samples collection
16122290|NCT01993472|Drug|Andrographolides|comparison of efficacy of Andrographolides combined with Capecitabine or Capecitabine alone in treatment of colorectal cancer
16122291|NCT01993472|Drug|Capecitabine|
16122292|NCT01993459|Drug|Midazolam|We will administer Midazolam 3mg intravenously once pre-operatively to patients just before they undergo surgery
16122293|NCT01993459|Drug|NaCl (sodium chloride) 0,9%|We will administer NaCl (sodium chloride) 0,9% 3ml intravenously once pre-operatively to patients just before they undergo surgery
16122294|NCT01993446|Drug|DRM02|
16122295|NCT01993446|Other|Vehicle|
16122296|NCT01993433|Drug|DRM02|
16122297|NCT01993433|Other|Vehicle|
16122298|NCT01993420|Drug|DRM02|
16122299|NCT01993420|Other|Vehicle|
16122300|NCT01993407|Behavioral|Task Switching Training|Participants will complete four, one-hour training sessions in which they will practice switching between tasks within an alternating runs task switching paradigm.
16122301|NCT01993407|Behavioral|Control Task|Participants will complete four, one-hour training sessions in which they will perform a single task each session
16122302|NCT01993394|Other|hypergravity|1hr sitting rest followed by 10 min of hypergravity (2 centrifuge runs)
16122303|NCT01993394|Other|gas mixture|breathing air, 44.5%O2 or 100%O2
16122304|NCT01993368|Other|flow cytometry|"These populations will be identified by different combinations of antibodies to identify:
~T cell subsets (CD45, CD3, CD4, CD8, CD45RA, CD69, CD28, TCRαβ, TCRγδ, CD197, CD25, FoxP3), B cells (CD45, CD19, HLA-DR, IgA), cells NK (CD45, CD3, CD56).
~Monocyte subsets (CD45, CD11b, CD14, CD16, CD1c, HLA-DR)
~Mesenchymal stromal cells (CD45, HLA-ABC, CD105, CD90, CD73)"
16122305|NCT01993355|Other|Physiotherapy|Physical therapy exercise program for CLBP patients. Its goal is to reduce pain and improve patients' health-related quality of life, functional capacity and well-being.
16122306|NCT01993355|Other|Intervention 1|Relaxation techniques-sophrology consists of a set of physical and relaxation exercises that include breathing methods, visualization, modification of states of consciousness, etc. with the goal to enhance balance between body and mind to improve health-related quality of life, reduce pain and foster patients' well-being.
16122307|NCT01993355|Behavioral|Intervention 2|Cognitive-behavioral therapy (in combination with motivational interviewing principles) is aimed to facilitate psychological adjustment and self-management of CLBP with the ultimate goal of increasing patients' health-related quality of life and well-being.
16122308|NCT01993342|Other|arthrocentesis|The made a diagnostic arthrocentesis to all patient we included
16122309|NCT01993342|Other|ultrasonography of the knee|We explored the affected knee with an ultrasound explanation in order to describe inflammatory changes based on standard examination.
16122310|NCT01993329|Drug|Gefapixant 50 mg|Gefapixant 50 mg tablet administered orally
16122311|NCT01993329|Drug|Gefapixant 300 mg|Gefapixant 300 mg tablet administered orally
16122312|NCT01993329|Drug|Placebo to mimic 50 mg tablets|Sugar pill manufactured to mimic gefapixant 50 mg tablets
16122313|NCT01993329|Drug|Placebo to mimic 300 mg tablets|Sugar pill manufactured to mimic gefapixant 300 mg tablets
16122314|NCT01993316|Device|Mitsar 201 neurofeedback|
16122315|NCT01993290|Drug|Ropivacaine|20 ml in total of 0,75% Ropivacaine is administered to each patient in all three arms.
16122316|NCT01993277|Device|Nexalin Brain Stimulator|
16122317|NCT01993277|Device|Fischer Wallace Stimulator|
16122318|NCT01993277|Device|David Delight Stimulator|
16122319|NCT01993277|Behavioral|Relaxation Therapy|
16122320|NCT01993264|Other|Fetal Echocardiogram|Subjects will then have sequential, abbreviated fetal echocardiograms performed by designated, highly trained, and experienced sonographers every 4 weeks, from 20-36 weeks.
16122321|NCT01993251|Drug|melatonin|one capsule, melatonin 0.5 mg, oral, once a day, 30 minutes before bedtime
16122322|NCT01993251|Drug|Melatonin|one capsule, melatonin 2 mg, oral, once a day, 30 minutes before bedtime
16122323|NCT01993251|Drug|Melatonin|one capsule, melatonin 6 mg, oral, once a day, 30 minutes before bedtime
16122324|NCT01993251|Drug|placebo|one capsule, placebo, oral, once a day, 30 minutes before bedtime
16122325|NCT01993238|Device|Liposonix System (Model 2)|Treatment of subcutaneous adipose tissue of the abdomen using high intensity focused ultrasound (Liposonix System Model 2).
16122326|NCT01993238|Drug|Pre-treatment analgesia|Pre-treatment analgesia (combination of ondansetron, ketorolac, and hydromorphone)
16122327|NCT01993225|Drug|Androxal 12.5 mg/25 mg|
16122328|NCT01993225|Drug|Placebo Capsules|
16122329|NCT01993225|Drug|AndroGel 1.62%|
16122330|NCT01993225|Drug|Placebo Gel|
16122331|NCT01993212|Drug|Androxal 12.5 mg or 25 mg|
16122332|NCT01993212|Drug|AndroGel 1.62%|
16122338|NCT01993173|Biological|Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap (ADACEL)|0.5 mL, Intramuscular
16122339|NCT01993173|Biological|DT vaccine (Diphtheria and Tetanus Combined Vaccine, Adsorbed)|0.5 mL, Intramuscular
16122340|NCT01993173|Biological|Td vaccine (Diphtheria and Tetanus Combined Vaccine for Adults and Adolescents, Adsorbed)|0.5 mL, Intramuscular
16122341|NCT01993160|Drug|Fluorocholine (18F-FCH) Injection|Before the PET-CT scan, the tracer (fluorocholine/FCH) will be injected into a vein in your arm just before the scan. This is the agent we are investigating in this study (not part of the standard procedure)
16122342|NCT01993160|Radiation|PET scan|A whole body PET scan will be performed, integrated with either whole body low dose CT or whole body MRI
16122343|NCT01993160|Radiation|Whole body MRI|A whole body MRI scan will be performed. This may be integrated with PET scan or performed separately.
16122344|NCT01993147|Behavioral|Dual task paradigm pilot|
16122345|NCT01993134|Procedure|Cefazolin|Cefazolin, 2g/IV, prior to surgery, and after surgery recieved 4 aditional doses 1g/IV of Cefazolin.
16122346|NCT01993134|Procedure|Cefazolin Single Dose|Patients received 2g of Cefazolin (Cefazolin Sodium - Ampoule- 1g - Genéricos Brasil), administered intravenously but none was administered in the post-operative period
16122347|NCT01993121|Other|Supervised Exercise Training|All subjects will perform three months of supervised exercise training.
16122348|NCT01993108|Drug|Methylphenidate|One dose 40mgs of methylphenidate one hour before fMRI scanning.
16122349|NCT01993108|Drug|Naltrexone|One dose 40mgs of naltrexone one hour before fMRI scanning.
16122350|NCT01993108|Drug|Placebo|One dose of placebo one hour before fMRI scanning.
16122351|NCT01993095|Behavioral|Home-based, DVD-delivered physical activity|Subjects will be participating in a home-based physical activity program that focuses on flexibility, toning and balance. Exercises will be progressive over the six-months and will highlight modifications for varying levels. This program will be delivered on 3 DVDs. Participants will be asked to exercise with the DVD at least three times per week.
16122352|NCT01993095|Behavioral|Behavioral: Usual care/Wait list|Participants in this arm will receive a DVD that focuses on healthy aging topics but does not include physical activity. They will receive the FlexToBa DVD after the completion of the 6-month follow-up testing.
16122353|NCT01993082|Behavioral|Aerobic Training Intervention|"For 24 weeks, subjects randomized into the aerobic training group will be asked to increase their physical activity level to meet the Centers for Disease Control and Prevention recommendations for physical activity of 150 minutes per week of moderate activity.
~A first visit with a fitness coach support provider, followed by weekly coaching texts and phone calls, will provide the framework for the activities in which participants should engage."
16122354|NCT01993069|Behavioral|Iyengar-based Yoga Training|6 weekly Iyengar-based yoga classes
16122355|NCT01993056|Behavioral|"FIFA 11+"|
16122356|NCT01993056|Behavioral|"no FIFA 11+"|
16122357|NCT01993030|Device|HQ® Matrix Medical Wound Dressing|
16122358|NCT01993030|Device|Sidaiyi® wound dressing|
16122359|NCT01993017|Other|Cognitive Behavioral Therapy (CBT)|"The main intervention is the impact of screening on quality of life and health care costs. CBT is provided only if depressive symptoms are detected and participant prefers this type of treatment.
~CBT will be centrally telephone-administered by a trained CBT treatment specialist. The treatment specialist will work with local team members throughout a participant's involvement in the study, and will closely follow each participant until he or she has reached a requisite level of improvement ."
16122360|NCT01993017|Drug|Antidepressant Medication|"The main intervention is the impact of screening on quality of life and health care costs. Antidepressant Medication is provided only if depressive symptoms are detected and patient prefers this type of treatment.
~Antidepressants should be started at the lowest dose, but should be adjusted upward to be within the therapeutic range within 1 week, with further adjustment higher in the therapeutic range possible at 3-4 weeks. Dosage of the first medication selected will be in the therapeutic range by 3 weeks of the initial step, as tolerated."
16122361|NCT01993017|Other|Standard Care|Participants will receive standard care from either their primary care provider (PCP), or PCP-referred mental health provider in one of the arms, IF depressive symptoms are detected.
16122362|NCT01993017|Other|Depressive symptom screener|8-item Patient Health Questionnaire, PHQ-8
16122363|NCT01993017|Other|No intervention|
16122364|NCT01992991|Device|Transcranial direct current stimulation|Transcranial direct current stimulation of motor cortex
16122365|NCT01992978|Procedure|Radiofrequency-assisted Hepatectomy|Radiofrequency-assisted resection: separating the tumor from liver by using the probe of radiofrequency to block the arterial and vessels before parenchymal transection.
16122366|NCT01992978|Procedure|Conventional Hepatectomy|Hepatectomy was conducted without RF assisted during parenchymal transection. Separating and dissecting the tumor with the routine clamp-crushing technical.
16122367|NCT01992965|Other|Different methods of blood glucose monitoring between groups|Finger prick blood glucose in conventional group versus real-time continuous glucose monitoring system of continuous glucose monitoring group
16122368|NCT01992952|Drug|AZD5363|Up to 480mg oral tablets twice a day, taken four days on, 3 days off treatment.
16122369|NCT01992952|Drug|Placebo|Placebo tablets taken twice a day, 4 days on treatment, 3 days off treatment
16122370|NCT01992952|Drug|Fulvestrant|2 x 250mg injections, received on Days 1 and 15 of cycle 1, and on day 1 of each subsequent 28 day cycle.
16122371|NCT01992939|Other|Specialized pulse oximetry probe with external heat pack|Pulse oximetry will be obtained using the specialized pulse oximetry probe with external heat pack for 45 minutes.
16122372|NCT01992939|Other|Standard of Care Pulse Oximetry Probe|Pulse oximetry will be obtained using a standard of care pulse oximetry probe for 45 minutes.
16122373|NCT01992926|Behavioral|interactive educational intervention|Use of a concise, literacy-sensitive, physician-led, educational interaction with the patient.
16122374|NCT01992913|Behavioral|integrated Cognitive Behavioral Therapy|Novel CBT paradigm for schizophrenia/schizoaffective disorder
16122375|NCT01992913|Other|Usual Care|The usual care that Veterans receive - not limited in scope (i.e., subjects may participate in any/all available treatments, outside the study condition)
16122376|NCT01992913|Behavioral|Computerized cognitive remediation (CCR)|Part of the iCBT paradigm, a four month block of bi-weekly computerized cognitive remediation using BrainHQ program.
16122377|NCT01992900|Drug|Eurartesim dispersible oral tablet|The first dose of Eurartesim dispersible oral tablet will be administered immediately after randomization. the other two doses will be administered with an interval of 24 hours. Eurartesim tablet will be dispersed in about 10 mL of water.
16122378|NCT01992900|Drug|eurartesim film coated tablet|The first dose of Eurartesim film coated tablet will be administered immediately after randomization. the other two doses will be administered with an interval of 24 hours. tablet will be crushed and dispersed in a few amount of water (about 10 ml).
16122379|NCT01992874|Drug|Pimasertib Capsule (Part A)|Pimasertib capsule administration at a single dose of 60 milligram (mg) orally on Day 1 in Part A.
16122380|NCT01992874|Drug|Pimasertib Tablet (Part A)|Pimasertib tablet administration at a single dose of 60 mg orally on Day 3 in Part A.
16122381|NCT01992874|Drug|Pimasertib Tablet (Part A)|Pimasertib tablet administration at a single dose of 60 mg orally on Day 1 in Part A.
16122382|NCT01992874|Drug|Pimasertib Capsule (Part A)|Pimasertib capsule administration at a single dose of 60 mg orally on Day 3 in Part A.
16122383|NCT01992874|Drug|Pimasertib Capsule (Part B and trial extension phase)|Subjects completing Part A to receive pimasertib capsule at a dose of 60 mg orally twice daily in cycles of 21 days each in Part B and trial extension phase until disease progression, intolerable toxicity, subject withdrawal, loss to follow-up or death.
16122384|NCT01992861|Procedure|Computed Tomography|Undergo FDG PET/CT
16122385|NCT01992861|Procedure|Diffusion Weighted Imaging|Undergo DW MRI
16122386|NCT01992861|Procedure|Dynamic Contrast-Enhanced Magnetic Resonance Imaging|Undergo DCE MRI
16122387|NCT01992861|Radiation|Fludeoxyglucose F-18|Undergo FDG PET/CT
16122388|NCT01992861|Procedure|Magnetic Resonance Spectroscopic Imaging|Undergo MR spectroscopy
16122389|NCT01992861|Procedure|Positron Emission Tomography|Undergo FDG PET/CT
16122390|NCT01992848|Other|Venous blood sampling|40ml venous blood sampling will be undertaken during participants' attendance for CT coronary angiography (the latter being performed as part of routine clinical investigation).
16122391|NCT01992848|Other|4-day food diary|
16122392|NCT01992848|Other|1 week UV dosimeter|To be worn on outerwear for one week week prior to attendance for pQCT
16122393|NCT01992848|Radiation|Peripheral Quantitative Computed Tomography of the radius|To be performed within one month of attendance for CT coronary angiography
16122394|NCT01992835|Other|Grass pollen allergen extract|Each subject will be challenged with a grass pollen allergen extract and with placebo.
16122395|NCT01992835|Other|placebo|
16122396|NCT01992822|Other|experimental pain induction|application of a pre-fixed pressure (160 kPa) on the forearm.
16122397|NCT01992809|Dietary Supplement|Omega 3|Omega-3 group (n=30) received capsules containing 945 mg of Omega-3 PUFA [α linolenic acid/ 64%, eicosapentaenoic acid (EPA)/16% and docosahexaenoic acid (DHA)/21%], in 3 capsules/ day
16122398|NCT01992796|Drug|Irbesartan|75 mg/per os/for 15 days
16122399|NCT01992783|Dietary Supplement|Hi-maize resistant starch|13.5 g/day
16122400|NCT01992783|Dietary Supplement|Maltodextrin|13.5 g/day
16122401|NCT01992770|Behavioral|Hierarchical graded exposure|"Individual Behavioural goal identification, depending on risk profile
~(1a). Catastrophising and/or fear-avoidance (2); hierarchical graded exposure, organized with individual coaching in connection to the physical training sessions, based on activities that each participant fear and/or avoid."
16122402|NCT01992770|Behavioral|Graded activity|"Individual Behavioural goal identification, depending on risk profile
~(1b) Graded activity;(2) self-monitoring of everyday life activities (3) functional behavioural analyses to describe, predict, and verify factors controlling patient's current and future activity performance (4) training of motor skills, cognitive skills, and strategies to organise everyday life including social support. (5) gradual application of acquired skills in everyday life situations as formulated by Specific, Measureable, Activity-related, Realistic, and Time- specified (SMART) goal setting (6) generalisation of skills to additional activities and challenging situations, and (7) strategies for maintenance and relapse prevention."
16122403|NCT01992770|Behavioral|Physical exercises|Participants will be scheduled for supervised, regular physical training twice a week during eight weeks 8
16122404|NCT01992731|Other|Drug: Follitropine Bèta|
16122405|NCT01992718|Procedure|Evaluation of MRI, US for pelvic and uterine conditions|"Pelvic ultrasound with transabdominal and transvaginal imaging. The transvaginal ultrasound will include elastography (TVUS-E). Also, a pelvic MRI will be performed if not done in the last 6 months. The MRI is performed with IV gadolinium-based contrast (MultiHance ®).
~A patient survey will be included."
16122406|NCT01992718|Procedure|Patient preference between MRI and Ultrasound|"Subjects may take part in this arm because they have recently had a MRI performed and scheduled for, or have recently undergone a pelvic ultrasound.
~Subjects will also be asked to complete a survey that will state their preference with regards to examination/imaging. This will be done over the phone and will take no longer than 30 minutes to complete."
16122407|NCT01992705|Other|Chemotherapy(FOLFIRINOX) + SBRT prior to surgery if applicable|Patients will receive chemotherapy (21d/cycle for a total of 4 cycles) plus SBRT before screening for surgical resection of the pancreas.
16122408|NCT01992705|Drug|-Oxaliplatin 85 mg/m2 IV on Day 1|Oxaliplatin 85 mg/m2 IV on Day 1 of each cycle (21d/cycle for a total of 4 cycles).
16122409|NCT01992705|Drug|-Irinotecan 180 mg/m2 IV on Day 1|Irinotecan 180 mg/m2 IV on Day 1 of each cycle (21d/cycle for a total of 4 cycles).
16122410|NCT01992705|Drug|-5-FU (Fluorouracil) 2,400 mg/m2 IV over 46-48 hours|5-FU (Fluorouracil) 2,400 mg/m2 IV over 46-48 hours of each cycle (21d/cycle for a total of 4 cycles.
16122411|NCT01992679|Behavioral|Exercise group|The BWSTT program will consist of biweekly training sessions for 20 weeks. Per neurorecovery network guidelines, each training session will include a minimum of 20 minutes of locomotor training and 20 minutes of balance training. Training will take place on a Therastride which consists of a treadmill with an air pressure powered pulley system connected to a harness system. The locomotor training strategy focuses on proper gait mechanics, including weight bearing, shifting and maintaining body positioning. Manipulating the participant's legs is done in such a way as to provide appropriate sensory-motor cues that facilitate the development and refinement of walking pattern.
16122412|NCT01992666|Genetic|Blood sampling|Immunologic and genetic analysis from a single blood sample.
16122484|NCT01992094|Biological|QIVc|Novartis Investigational Quadrivalent Vaccine
16122413|NCT01992653|Drug|Cyclophosphamide|Cyclophosphamide will be administered at 750 milligrams per square meter (mg/m^2) IV every 3 weeks (starting from Cycle 1 Day 1), for 6 or 8 cycles.
16122414|NCT01992653|Drug|Doxorubicin|Doxorubicin will be administered at 50 mg/m^2 IV every 3 weeks (starting from Cycle 1 Day 1), for 6 or 8 cycles.
16122415|NCT01992653|Drug|Obinutuzumab|Obinutuzumab will be administered at 1000 milligrams (mg) IV on Cycle 1 Days 1, 8, and 15 and on Day 1 of Cycles 3-8.
16122416|NCT01992653|Drug|Polatuzumab Vedotin|Polatuzumab vedotin will be administered at escalating doses (at a starting dose of 1 mg/kg) IV every 3 weeks, for 6 or 8 cycles.
16122417|NCT01992653|Drug|Prednisolone|Prednisolone will be administered at 100 mg orally daily for 5 days every 3 weeks (starting from Cycle 1 Day 1), for 6 or 8 cycles. Prednisone at 100 mg orally from Day -7 to Day -1 may be given at the discretion of the treating investigator physician.
16122418|NCT01992653|Drug|Prednisone|Prednisone will be administered at 100 mg orally daily for 5 days every 3 weeks (starting from Cycle 1 Day 1), for 6 or 8 cycles. Prednisone at 100 mg orally from Day -7 to Day -1 may be given at the discretion of the treating investigator physician.
16122419|NCT01992653|Drug|Rituximab|Rituximab will be administered at 375 mg/m^2 IV every 3 weeks (starting from Cycle 1 Day 1), for 6 or 8 cycles.
16122420|NCT01992627|Device|HILTERAPIA HIRO 3.0|High-intensity laser therapy (HILT), which involves higher-intensity laser radiation and which causes minor and slow light absorption by chromophores. This absorption is obtained not with concentrated light but with diffuse light in all directions (the scattering phenomenon), increasing the mitochondrial oxidative reaction and adenosine triphosphate, RNA, or DNA production (photochemistry effects) and resulting in the phenomenon of tissue stimulation called photobiology.
16122421|NCT01992614|Drug|PF-06678552 or Placebo|PF-06678552 or placebo will be administered as an extemporaneously prepared solution once in each period.
16122422|NCT01992614|Drug|PF-06678552 or Placebo|PF-06678552 or placebo will be administered as an extemporaneously prepared solution once in each period.
16122423|NCT01992614|Drug|PF-06678552 or Placebo|PF-06678552 or placebo will be administered as an extemporaneously prepared solution once in each period.
16122424|NCT01992601|Drug|Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg)|"For co-administration, Crestor 1 tablet and Micardis 1 tablet a day for 6 days in each period.
~For separate administration, Crestor 1 tablet a day for 6 days and Micardis 1 tablet a day for 6 days in each period."
16122425|NCT01992588|Drug|Faster-acting insulin aspart|"Subjects - in a euglycaemic clamp setting - will receive a priming (initial) dose followed by a continuous basal rate infusion and finally a bolus dose on top of the basal rate infusion.
~The trial products will be administered subcutaneously (s.c. under the skin) by means of an insulin pump."
16122426|NCT01992588|Drug|insulin aspart|"Subjects - in a euglycaemic clamp setting - will receive a priming (initial) dose followed by a continuous basal rate infusion and finally a bolus dose on top of the basal rate infusion.
~The trial products will be administered subcutaneously (s.c. under the skin) by means of an insulin pump."
16122427|NCT01992562|Drug|Ziconotide|
16122428|NCT01992562|Drug|placebo|
16122429|NCT01992549|Biological|Human-cl rhFVIII|
16122430|NCT01992536|Biological|MenABCWY+OMV|"Vaccine contains rMenB (50 µg per antigen) with 25 µg of OMV (a full dose) plus the fully lyophilized MenACWY vaccine"
16122431|NCT01992536|Biological|MenABCWY+¼OMV|Vaccine contains rMenB (50 µg per antigen) with 6.25 µg OMV (1/4 dose) plus the fully lyophilized MenACWY vaccine
16122432|NCT01992536|Biological|Placebo|Saline solution for injection (0.5mL)
16122433|NCT01992523|Drug|Ticagrelor mashed pills|The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor). Mashed pills administration will be prepared placing 2 ticagrelor pills in a mortar and mashing for 60 seconds using a pestle. The total contents of the mortar will be transferred to the dosing cup, 50 mL of purify water will be added, and the suspension mixed up before drinking. Afterwards, 100 mL of purify water will be administered to the patient.
16122434|NCT01992523|Drug|Ticagrelor integral pills|The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In all case before the end of the PCI (percutaneous coronary intervention) . In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered (90 mg Ticagrelor).
16122435|NCT01992497|Dietary Supplement|Probiotic|
16122436|NCT01992471|Behavioral|Pre-test Assessment|Subjects who consent to the study will complete a pre-test instrument that elucidates their baseline response to genetic testing (BRCA1/2) as measured by the Multidimensional Impact of Cancer Risk Assessment (MICRA), and their current cancer surveillance and prevention behaviors, as well asintentions to undergo surveillance and prevention in the next 6 months. The instrument will either be completed at the time of the counseling for multiplex testing, or by phone within approximately 7 days of sample donation.
16122437|NCT01992471|Behavioral|Pre test Counseling|Subjects will receive appropriate pre-test counseling that will describe the range of outcomes that may results from the multiplex testing. The subject will be asked for permission to audiotape the session for later qualitative review. An outline of the pretest counseling that will be provided. In addition to a description of the genes and syndromes being tested, subjects will receive specific education regarding the following categories and subcategories of possible results a. Definitive (informative) results, b. Variants of uncertain clinical significance (VUCS), c. Uninformative negative test results, d. d. Incidental results. Then Post-counseling selection of desired information After counseling, subjects will complete an instrument indicating which genetic test results they wish to receive. They will complete this instrument in the presence of a genetic counselor, so that the subject may ask questions in order to make the choice most consistent with their preferences.
16122438|NCT01992471|Other|Blood draw|After choosing the information they wish to receive, subjects will provide a blood sample (2 x 7 cc EDTA tubes, which will be sent to Myriad Genetics Laboratory for analysis.
16122439|NCT01992471|Behavioral|Post-test counseling, and post-test assessment|When results are available, subjects will be asked to return for in-person communication of the results. Results will be disclosed after confirmation of information preferences in a standard genetic counseling session.
16122485|NCT01992094|Biological|TIV1c|Licensed Influenza Vaccine
16122486|NCT01992094|Biological|TIV2c|Novartis Investigational Vaccine
16122440|NCT01992471|Behavioral|Follow-up assessments (6 and 12 months)|At 6 and 12 months post-results transmission (+/- 4 weeks), subjects will be contacted by telephone by the study RSA to complete follow-up instruments (Assessments 3 and 4; They will complete, by phone, the MICRA. They will also describe the surveillance and prevention behaviors of the preceding 6 months, and their intentions for the next 6 months. Subjects who express a high degree of distress will be offered referral to the Counseling Service, facilitated by Dr. Hay.
16122441|NCT01992393|Behavioral|TIME|TIME consists of 12 group sessions in which patients with epilepsy and mental illness will be coached on techniques to help manage their conditions. There will also be four follow-up telephone sessions after the series of group sessions is completed. In addition, approximately half of the participants will participate in qualitative interviews.
16122442|NCT01992380|Drug|Flortaucipir F18|IV injection, 370 MBq (10 mCi), two doses up to four weeks apart
16122443|NCT01992380|Procedure|Brain PET scan|positron emission tomography (PET) scan of the brain at 80-100 and 110-130 minutes after injection
16122444|NCT01992367|Drug|ASLAN003 ACTIVE|This is a single-centre, placebo-controlled, randomised, double-blind study involving SAD and MAD of ASLAN003 in healthy subjects.
16122445|NCT01992354|Device|PET MR Device|GE PET/MRI system
16122446|NCT01992341|Drug|AMG 386|Weekly 15 mg/kg of AMG 386 in combination with three weeks on/ one week off 80mg/m2 of paclitaxel. Continued therapy with AMG 386 with or without paclitaxel until progression, unacceptable toxicity develops, or study withdrawal.
16122447|NCT01992341|Drug|Paclitaxel|Three weeks on/ one week off 80mg/m2 of paclitaxel in combination with weekly 15 mg/kg of AMG 386 . Continued therapy with AMG 386 until progression, unacceptable toxicity develops, or study withdrawal. A cycle consists of 3 weeks on / 1 week off of paclitaxel.
16122448|NCT01992328|Drug|Immune Globulin|6 months once a month intravenous immunoglobulin (400mg/kg/4weeks)
16122449|NCT01992315|Device|Adipose-derived ECM|Each syringe of adipose-derived ECM will hold 2mL and will be for single use only. Up to 3 syringes (6mL total) may be used for each patient. Injections will be made under local anesthesia and sterile conditions using a 23-gauge needle. All injections will be performed in an outpatient clinic setting at study site by the principal investigator who will determine the method, depth, and volume of each implant. Decellularized adipose tissue-derived matrix will be infiltrated into the defect and the underlying musculature as well as the subcutaneous tissue surrounding the defect, with the goal of creating a smooth transition from surrounding structures to the filled defect. This will be performed using a series of multiple punctures or a single puncture with a fanning or threading technique. After the injection is completed, the treatment area will be massaged to conform to the contour of the surrounding tissue and ice will be applied as needed for swelling.
16122450|NCT01992289|Drug|EDI200|Long-term follow-up study of subjects that received EDI200 as part of protocol ECP-002
16122451|NCT01992276|Biological|CR8020|30 mg/kg administered as a single 2-hour intravenous infusion on Day 1
16122452|NCT01992276|Biological|CR6261|30 mg/kg administered as a single 2-hour intravenous infusion on Day 1
16122453|NCT01992276|Biological|Placebo|Administered as a single 2-hour intravenous infusion on Day 1
16122454|NCT01992263|Dietary Supplement|Vitamin D (600 IU)|Daily oral dose for 12 months
16122455|NCT01992263|Dietary Supplement|Vitamin D (2000 IU)|Daily oral dose for 12 months
16122456|NCT01992263|Dietary Supplement|Vitamin D (4000 IU)|Daily oral dose for 12 months
16122457|NCT01992263|Other|Placebo|Daily oral dose for 12 months
16122458|NCT01992250|Device|Visica 2 Treatment System|Cryoablation
16122459|NCT01992224|Other|early mechanical Ventilation|"Fulfillment of three or more criteria below:
~respiratory rate > 28 per minute serum lactate > 3 mmol/L PaO2/FiO2 Index <300 mmHg SvO2 < 65% lung infiltration or atelectasis, pleural exudation"
16122460|NCT01992224|Other|Conventional Mechanical Ventilation|other group who don't start early mechanical ventilation and fulfillment four criteria below: respiratory rate > 28 bpm dyspnea PaO2/FiO2 Index <200 mmHg Chest X-ray: lung infiltration exclude chronic heart failure and pulmonary disease
16122461|NCT01992211|Drug|Rosuvastatin|Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.
16122462|NCT01992211|Drug|Metformin|Participants will be co-administered a single oral dose of Rosuvastatin 10mg and Metformin SR 1000mg under Fed condition.
16122463|NCT01992211|Drug|BCWP_C003|Participant will be administered a single oral dose of BCWP_C003 under Fasting condition or Fed condition according to sequence.
16122464|NCT01992198|Drug|cefoperazone + metronidazole|"1.Clinical parameters (2 of 3):
~1)temperature<37.8℃ or 2)HR <100bpm or 3)SpO2 >95% 2.Laboratory parameters (3 of 3):
~1)CRP or 2)PCT reduction 70% compared to zenith for 2 consecutive samples 3)WBC <12×10E9/L for 2 consecutive samples 3.Image parameter (1 of 1): liquid collection developed <30% compared to that of 72h"
16122465|NCT01992198|Procedure|oral care by chlorhexidine gluconate|oral care by 0.2% chlorhexidine gluconate twice daily
16122466|NCT01992198|Procedure|enteral nutrition|
16122467|NCT01992198|Drug|Somatostatin|
16122468|NCT01992198|Drug|Meropenem|"All patients in cefo-group do not meet 1 of 3 laboratory parameter or image parameter or 2 of 3 clinical parameters.
~1.Clinical parameters (2 of 3):
~1)temperature<37.8℃ or 2)HR <100bpm or 3)SpO2 >95% 2.Laboratory parameters (3 of 3):
~1)CRP or 2)PCT reduction 70% compared to zenith for 2 consecutive samples 3)WBC <12×10E9/L for 2 consecutive samples 3.Image parameter (1 of 1): liquid collection developed <30% compared to that of 72h"
16122469|NCT01992185|Drug|Photocil for Vitiligo|Photocil for Vitiligo
16122470|NCT01992185|Other|Placebo - Sunscreen (SPF 2)|Placebo - Sunscreen (SPF 2)
16122471|NCT01992172|Drug|Photocil for Atopic Dermatitis|Photocil for Atopic Dermatitis
16122472|NCT01992172|Other|Placebo - Sunscreen (SPF 2)|Placebo - Sunscreen (SPF 2)
16122473|NCT01992159|Drug|Romosozumab|Administered by subcutaneous injection
16122474|NCT01992159|Drug|Placebo|Administered by subcutaneous injection
16122475|NCT01992146|Drug|Target-controlled naloxone-infusion|
16122476|NCT01992146|Drug|Placebo|
16122477|NCT01992133|Dietary Supplement|Vitamin D3|
16122478|NCT01992133|Dietary Supplement|Placebo|
16122479|NCT01992120|Other|Debriefing of high-fidelity sepsis simulation scenarios|Educational intervention
16122480|NCT01992120|Other|Placebo: Debriefing of high-fidelity non-sepsis simulation scenarios|
16122481|NCT01992107|Biological|QIVc|Novartis Investigational Quadrivalent Vaccine
16122487|NCT01992081|Device|Automated telehealth system|The automated telehealth system (used within its intended use) comprises of CE marked medical devices and a CE marked step counter (Fitbug®), all being used within their intended use. Coaching by investigators is performed during the study visits and is aimed to enhance physical activity in patients across a spectrum of COPD severity, in addition to the usual care.
16122488|NCT01992081|Other|Usual care|Participants will receive usual care associated with Chronic Obstructive Pulmonary Disease (COPD)
16122489|NCT01992055|Behavioral|Goal Management Training|Participants will be randomly assigned to the GMT Treatment. The GMT cognitive rehabilitation intervention program will be administered in group format, consisting of 8 sessions, including structured psychoeducation, relaxation training, and stepwise learning of GMT.
16122490|NCT01992055|Behavioral|Education & relaxation training|The Education & Relaxation Training Control Group program will also be administered in group format, consisting of two sessions, including structured psychoeducation and relaxation training. Participants assigned to the Control condition will be offered the opportunity to complete the full GMT program following the completion of the study.
16122491|NCT01992042|Drug|Fluvastatin|HMG-CoA reductase inhibitors that lowers cholesterol levels. 40mg twice daily
16122492|NCT01992042|Drug|Pimonidazole|
16122493|NCT01992029|Other|Clinical evaluation|Clinical evaluation using MRC scale, Norris bulbar scale, ALSFRS score and respiratory evaluation ( Vital Capacity, PiMax and SNIP) at M0, M4, M8, M12
16122494|NCT01992029|Procedure|Muscular biopsy|Muscular biopsy at M0
16122495|NCT01992029|Procedure|Lumbar puncture|Lumbar puncture at M0 and M12
16122496|NCT01992029|Procedure|Blood sampling|Blood sampling at M0, M4, M4, M8 and M12
16122497|NCT01992029|Other|Neurological assessments|Neurological assessments (MRC score and cognitive scales: MMS and BREF)
16122498|NCT01992029|Procedure|Neuro-muscular biopsy and lumbar puncture|Neuro-muscular biopsy and lumbar puncture for patients explored for peripheral neuropathy
16122499|NCT01992029|Procedure|Muscular biopsy|Muscular biopsy for patient explored for myopathy
16122500|NCT01992029|Procedure|Blood sample|Blood sample for qRT PCR, detection and quantification for miRNA
16122501|NCT01992029|Device|Cervical spinal cord and brain MRI|ALS patients : MRI at inclusion and Month 8 Control patients suffering from neuropathy : MRI at inclusion and Month 8 Control patients suffering from myopathy : MRI at inclusion Control subjects : MRI at inclusion
16122502|NCT01992016|Drug|Ranolazine|1000mg given orally twice daily for 1 day (2 doses).
16122503|NCT01991990|Drug|placebo|Single i.v. infusion
16122504|NCT01991990|Drug|tocilizumab [RoActemra/Actemra]|Single 8 mg/kg i.v. infusion
16122505|NCT01991977|Procedure|Diffusion Weighted Imaging|Undergo DTI
16122506|NCT01991977|Drug|Fluorine F 18 Fluorodopa|Undergo 18F-DOPA-PET
16122507|NCT01991977|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16122508|NCT01991977|Procedure|Perfusion Magnetic Resonance Imaging|Undergo pMRI
16122509|NCT01991977|Procedure|Positron Emission Tomography|Undergo 18F-DOPA-PET
16122510|NCT01991977|Other|Quality-of-Life Assessment|Ancillary studies
16122511|NCT01991977|Drug|Temozolomide|Receive temozolomide
16122512|NCT01991964|Other|laryngeal ultrasound|
16122513|NCT01991951|Drug|warfarin|
16122514|NCT01991938|Drug|VS-5584|
16122515|NCT01991925|Other|Interviews, questionaires, RAND-modified delphi method round|phase 1: RAND-modified delphi method round with experts in hereditary haemochromatosis phase 2: patient interviews, questionaires and focusgroup interviews
16122516|NCT01991912|Procedure|open lumbar decompression|A posterior midline incision is performed over the affected levels. Bilateral subperiosteal dissection of the paraspinal muscles is performed. Bilateral hemilaminotomies, foraminotomies and lateral recess decompression is performed followed by wound closure
16122517|NCT01991899|Biological|MMR Bio-Manguinhos|1170 children will receive 100% produced by Bio-Manguinhos, 3 diferents lots. Application of a 0.5 ml dose, subcutaneous 390 children will receive 0,5 ml, subcutaneous, MMR GlaxoSmithKline
16122518|NCT01991899|Biological|MMR GlaxoSmithKline|390 children will receive 0,5 ml MMR GlaxoSmithKline
16122519|NCT01991886|Device|Vapotherm Precision Flow|Application of nasal High Flow using 6-7 l/min delivered by nasal prongs from birth
16122520|NCT01991873|Drug|Maintenance Chemotherapy|
16122521|NCT01991873|Drug|Panitumumab (Within maintenance phase)|
16122522|NCT01991873|Drug|mFOLFOX6 (Within re-induction phase)|
16122523|NCT01991873|Drug|Panitumumab (Within re-induction phase)|
16122524|NCT01991860|Drug|APD421- Amisulpride for IV injection|APD421 ( Amisulpride) at 5mg given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia
16122525|NCT01991860|Drug|Placebo|Matching Placebo given by single intravenous (IV) administration, by slow push over one minute, at induction of anaesthesia
16122526|NCT01991847|Behavioral|Physical activity|The patients will perform increasing volumes of moderate intensity endurance (e.g. walking, cycling) exercise, leading up to 18 MET-hours per week by the end of three months. Patients will then maintain this activity level for the remaining 9 months, with reduced supervision.
16122527|NCT01991834|Procedure|gynecologic laparoscopy|Gynecological laparoscopy without opening hollow viscera.
16122528|NCT01991834|Drug|Cefazolin|Intravenous administration of 1 g of cefazolin
16122529|NCT01991834|Drug|Placebo|Intravenous administration of saline sterile solution
16122530|NCT01991821|Drug|APD421|
16122531|NCT01991821|Drug|Placebo|
16122532|NCT01991808|Radiation|Radiotherapy|
16122533|NCT01991795|Drug|Ticagrelor 60 mg|Ticagrelor 60 mg bd taken orally as tablets
16122534|NCT01991795|Drug|Ticagrelor placebo|Ticagrelor placebo bd taken orally as tablets
16122535|NCT01991782|Other|Telemedicine|Patients in the telemedicine cohort will have two follow-up visits (at 6 weeks and 6 months) through video calls.
16122536|NCT01991769|Behavioral|47 min moderate intensity training|
16122537|NCT01991769|Behavioral|exercise healthy volunteers|
16122538|NCT01991769|Behavioral|control; no exercise training|
16122539|NCT01991756|Device|Altura Endograft System|Subjects with a documented untreated, unruptured, infrarenal abdominal aorto-iliac aneurysm.
16122540|NCT01991743|Drug|Group 2.5|Administration of bupivacaine 2.5 mg.
16122542|NCT01991743|Drug|Group 7.5|Administration of 7.5 mg bupivacaine
16122543|NCT01991743|Drug|Group 10|Administration of 10mg bupivacaine.
16122544|NCT01991717|Device|Victus|The anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery
16122545|NCT01991717|Device|Conventional Phaco|The capsulotomy as well as the lens fragmentation is performed manually.
16122546|NCT01991691|Device|Tablet-based questionnaire|tablet-based patient reported outcomes (TabPRO)
16122547|NCT01991678|Drug|145 mg/m2 NKTR 102|
16122548|NCT01991678|Drug|120 mg/m2 NKTR 102|
16122549|NCT01991678|Drug|50 mg/m2 NKTR 102|
16122550|NCT01991665|Other|Digital examination|
16122551|NCT01991665|Other|Sonography evaluation|
16122552|NCT01991639|Other|Nutritional and physical activity intervention|Buddies visit malnourished, frail, elderly subjects twice a week for approximately one hour and they perform nutritional and physical activity interventions.
16122553|NCT01991626|Dietary Supplement|micronutrient powder|
16122554|NCT01991626|Dietary Supplement|micronutrient powder (containing FeSO4), phytase|
16122555|NCT01991626|Dietary Supplement|Iron pyrophosphate (FePP)|
16122556|NCT01991626|Dietary Supplement|Iron sulphate|
16122557|NCT01991613|Dietary Supplement|liquid protein supplement|The liquid protein supplement is already in use. The purpose of this study is to determine whether using the supplement earlier will lead to improved growth.
16122558|NCT01991600|Dietary Supplement|ferrous sulphate|
16122559|NCT01991600|Dietary Supplement|ferric iron oxide-organic acid (Fe-OA)|
16122560|NCT01991587|Biological|Low dose of quadrivalent VLP vaccine|A single low dose of quadrivalent VLP vaccine
16122561|NCT01991587|Biological|Medium dose of quadrivalent VLP vaccine|A single medium dose of quadrivalent VLP vaccine
16122562|NCT01991587|Biological|High dose of quadrivalent VLP vaccine|A single high dose of quadrivalent VLP vaccine
16122563|NCT01991587|Biological|Placebo|A single dose of placebo
16122564|NCT01991574|Drug|Calcium acetate|
16122565|NCT01991574|Dietary Supplement|Iron Hydroxide Adipate|
16122566|NCT01991574|Drug|Placebo|methylcellulose capsules
16122567|NCT01991561|Biological|Low dose of H5 VLP vaccine + Alhydrogel|Biological: low dose of H5 VLP vaccine 2 doses given 21 days apart of low dose of H5 VLP vaccine mixed with Alhydrogel
16122568|NCT01991561|Biological|Med dose of H5 VLP vaccine + Alhydrogel|Biological:Med dose of H5 VLP vaccine 2 doses given 21 days apart of Med dose H5 VLP vaccine mixed with Alhydrogel
16122569|NCT01991561|Biological|High dose of H5 VLP vaccine + Alhydrogel|Biological: High dose of H5 VLP vaccine 2 doses given 21 days apart of High dose of H5 VLP vaccine mixed with Alhydrogel
16122570|NCT01991561|Biological|Low dose of H5 VLP vaccine + GLA-SE|Biological: low dose of H5 VLP vaccine 2 doses given 21 days apart of low dose of H5 VLP vaccine mixed with GLA-SE
16122571|NCT01991561|Biological|High dose of H5 VLP vaccine + GLA-SE|Biological: High dose of H5 VLP vaccine 2 doses given 21 days apart of High dose of H5 VLP vaccine mixed with GLA-SE
16122572|NCT01991561|Biological|Placebo comparator: Placebo|Biological: Placebo 2 doses given 21 days apart of the placebo
16122573|NCT01991548|Device|MiniMed® 640G Insulin Pump and Guardian® Link Transmitter|
16122574|NCT01991535|Device|Spontaneous Ventilation Mode|"Respiratory rate and duration of inspiration are controlled by the patient.
~Device model: Stellar 150® (ResMed, Australia)."
16122575|NCT01991535|Device|Controlled Ventilation Mode|"Ventilator maintains the positive end-expiratory pressure until the patient inspires. At that point, the ventilator reaches the support pressure in a predetermined time. The patient fixes the respiratory rate and the duration of inspiration, triggering all the cycles.
~Device model: Stellar 150® (ResMed, Australia)."
16122576|NCT01991535|Device|Simulator Ventilation Mode|"Ventilator maintains a continuous positive airway pressure during the entire cycle.
~Device model: Stellar 150® (ResMed, Australia)."
16122577|NCT01991522|Behavioral|Curriculum Group|
16122578|NCT01991522|Behavioral|Self-directed learning group|
16122579|NCT01991509|Biological|LBR-101 IV|LBR-101 Administered Intravenously
16122580|NCT01991509|Biological|LBR-101 SC|LBR-101 Administered Subcutaneously
16122581|NCT01991483|Drug|LY2928057|Administered intravenously
16122582|NCT01991483|Drug|Placebo|Administered intravenously
16122583|NCT01991470|Device|Enlite sensors|Subject wears enlite sensor first and followed by enlite 3 sensor.
16122584|NCT01991457|Drug|Fludarabine|
16122585|NCT01991457|Procedure|Total Body Irradiation|
16122586|NCT01991444|Other|TAVI|no Intervention planned, Observation only
16122587|NCT01991405|Device|Computerized Working Memory Training.|"Auditive and visual Working Memory tasks, administrated on a computer under guidance. 5 x 45 minutes per week, for 5 weeks. The intervention group will train at an adaptive level that is not to difficult nor to easy, which is hypothesized as optimal for learning and training effect. The placebo group will train with a sham program that is fixed (non-adaptive in difficulty level), but otherwise identical."
16122588|NCT01991392|Device|Nasogastric tube|For nasogastric decompression.
16122589|NCT01991392|Device|No nasogastric tube|For nasogastric decompression.
16122590|NCT01991379|Drug|MEK162|Patients should take the study drug with a glass of water. MEK162 can be taken with or without food.
16122591|NCT01991379|Drug|Imatinib Mesylate (Gleevec®; STI571; NSC #716051)|
16122592|NCT01991379|Other|Blood draws|
16122593|NCT01991379|Procedure|biopsy|Following informed consent, the first 20 mandatory patients, except for patients who have already been treated with imatinib prior to consent, and subsequent voluntary patients enrolled on the phase II portion of the trial will undergo research biopsies. Patients should hold both imatinib and MEK162 doses on the day they undergo a biopsy.
16122594|NCT01991353|Procedure|With PRP|Following meniscal repair, PRFM will be delivered arthroscopically into the tear site using a portal skid, arthroscopic canula and arthroscopic atraumatic tissue grasper into the interface of the repair site.
16122595|NCT01991353|Procedure|Without PRP|Standard of care meniscal repair without augmentation.
16122596|NCT01991327|Drug|Androxal|
16122597|NCT01991327|Drug|Placebo|
16122598|NCT01991314|Drug|Ferrous sulphate|200mg tablets.
16122817|NCT01989572|Other|Laboratory Biomarker Analysis|Correlative studies
16122599|NCT01991301|Drug|carfilzumib|carfilzumib will be added to the standard regimen of drugs for prevention of graft-versus-host disease.
16122600|NCT01991288|Procedure|SNB Saphenous Nerve Block|Patients in group SNB received an ultrasound guided SNB (a sub sartorial approach) by a single operator with 10 mls 0.5% bupivacaine. At the end of surgery periarticular knee infiltration of 30 mls 0.5% levobupivacaine + 70 mls 0.9% saline + 0.5 mg adrenaline was performed in a staged fashion by the surgeon, beginning with infiltration of the deep structures on tibial surface at 1mm depth around all exposed tissues, medial and lateral collateral ligament origin, all cut surfaces of extensor mechanism, all cut surface of skin and subcutaneous tissue
16122601|NCT01991288|Procedure|NSNB Non Saphenous Nerve Block|All patients at the end of surgery received periarticular knee infiltration of 30 mls 0.5% levobupivacaine + 70 mls 0.9% saline + 0.5 mg adrenaline, in a staged fashion by the surgeon, beginning with infiltration of the deep structures on tibial surface at 1mm depth around all exposed tissues, medial and lateral collateral ligament origin, all cut surfaces of extensor mechanism, all cut surface of skin and subcutaneous tissue
16122602|NCT01991275|Drug|The intravenous patient-controlled analgesia|The intravenous injection of morphine using the patient-controlled analgesia machine
16122603|NCT01991275|Drug|The intrathecal morphine injection|A single injection of morphine intrathecally
16122604|NCT01991249|Other|blood draw|
16122605|NCT01991236|Behavioral|Video|Educational video discussing risks and benefits of chronic use of systemic corticosteroids.
16122606|NCT01991236|Behavioral|Standard Script|Standard scripted discussion of risks and benefits of chronic corticosteroid usage read to patients.
16122607|NCT01991223|Drug|Dex infusion|Dexmedetomidine will be injected (1 mcg/kg for 10 minutes and afterward 0.3 mcg/kg/hr)
16122608|NCT01991223|Drug|NS infusion|Normal saline will be infused during surgery
16122609|NCT01991210|Drug|DNIB0600A|DNIB0600A will be administered at a dose of 2.4 mg/kg IV every 3 weeks.
16122610|NCT01991210|Drug|PLD|PLD will be administered at a dose of 40 mg/m^2 IV every 4 weeks.
16122611|NCT01991197|Drug|Sitagliptin|"Week 0-16: Two 50mg tablets (or one 50mg tablet for participants with moderate kidney disease) once daily for 16 weeks during the double-blind phase.
~Week 16-32: Then two 50mg tablets (or one 50mg tablet for participants with moderate kidney disease) once daily for 16 weeks during the open-label phase of the trial."
16122612|NCT01991197|Drug|Gliclazide|"Double-blind phase (week 0-16):
~One 80mg capsule once daily for 4 weeks. The if no severe hypoglycaemic episodes one 80mg capsule twice daily for 4 weeks.
~Then if no severe hypoglycaemic episodes two 80mg capsules twice daily for 8 weeks."
16122613|NCT01991197|Drug|Sitagliptin matched placebo|Week 0-16: Two tablets (or one tablet for those with moderate kidney disease) daily for 16 weeks during the double-blind phase.
16122614|NCT01991197|Drug|Gliclazide matched placebo capsule|"Double-blind phase (week 0-16):
~One capsule daily for 4 weeks. Then if no severe hypoglycaemic episodes one capsule twice daily for 4 weeks. Then if no severe hypoglycaemic episodes two capsules twice daily for 8 weeks."
16122615|NCT01991184|Drug|GDC-0853|Multiple escalating doses
16122616|NCT01991171|Other|Kinesio Taping|Kinesiotaping intervention is based upon the use of specific elastic tapes (known as Kinesio Tex Gold) that are applied with a certain amount of tension fixed to the skin of patients with the target muscles in a stretched position. The tapes will be placed over the quadriceps muscle.
16122617|NCT01991158|Drug|High dose of methotrexate|Methotrexate 3.0g/Kg, intravenous drip D1
16122618|NCT01991158|Drug|Gemcitabine|Gemcitabine 1g/m2 intravenous drip D1,D8
16122619|NCT01991158|Drug|Pegaspargase|Pegaspargase 2500U/m2 intramuscular injection (IM) D1
16122620|NCT01991158|Drug|Dexamethasone|Dexamethasone 20mg/d intravenous drip D1, po D2-3
16122621|NCT01991145|Procedure|Umbilical Cord Blood therapy|HLA (Human Leukocyte Antigen) typing
16122622|NCT01991145|Biological|Erythropoietin alfa|
16122623|NCT01991145|Other|Rehabilitation|Active rehabilitation
16122624|NCT01991145|Procedure|Placebo UCB|
16122625|NCT01991145|Biological|Placebo EPO|
16122626|NCT01991132|Other|MediView 2.0 software|
16122627|NCT01991119|Drug|Propafenone|
16122628|NCT01991119|Drug|Dronedarone|
16122629|NCT01991106|Behavioral|High intensity interval training|Twelve weeks of 2-3 supervised training sessions each week.
16122630|NCT01991106|Behavioral|Moderate intensity continuous training|Twelve weeks of 2-3 supervised training sessions each week.
16122631|NCT01991106|Dietary Supplement|Nutritional advice|healthy food choices, portion sizes and regular mealtimes
16122632|NCT01991080|Behavioral|biofeedback|Patients will go through biofeedback sessions
16122633|NCT01991080|Drug|Wheatgerm juice|Patient will drink wheatgerm juice
16122634|NCT01991067|Biological|TBE virus vaccine|TBE virus vaccine FSME Immun is used in both arms for the study population and the control group
16122635|NCT01991054|Dietary Supplement|vitamin D3|
16122636|NCT01991028|Drug|Radiolabelled OligoG CF-5/20 DPI|Inhalation with dry powder by Mia Monodose Inhaler
16122637|NCT01991028|Drug|Radiolabelled OligoG CF-5/20 6% Solution|Inhalation with aerosolised solution by nebuliser
16122638|NCT01991002|Behavioral|14/21 diet|"Diet program is divided into 3 periods: 1. Low carb diet for 14 days; 2. Low carb and regular diet in alternating days for 21 days; 3. Individual carbohydrate-rich diet for 21 days.
~The diet consists of a free choice of food ingredients from a detailed list of foods in each category (proteins, carbohydrates, vegetables, fat etc.). The participants are free to choose the types of food as long as they are within the specified allowance (quantity) for each food group."
16122639|NCT01990976|Device|MRI|In Paris centre, a total body NMR imaging will be done with standard T2- and T1-weighted images.
16122640|NCT01990976|Procedure|Biopsy|biopsy of the vastus lateralis muscle
16122641|NCT01990950|Device|Zenith® Fenestrated AAA Endovascular Graft|The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System is indicated for the endovascular treatment of patients with abdominal aortic or aortoiliac aneursyms having morphology suitable for endovascular repair
16122642|NCT01990937|Drug|Oral midazolam|5 mg in 15 mL of apple juice, orally 30 minutes before undergoing EGD
16122643|NCT01990924|Radiation|15 FPS|X-ray pictures
16122644|NCT01990924|Radiation|7.5 FPS|X-ray pictures
16122680|NCT01990625|Device|Antenatal Ultrasound Scan|Women in the intervention arm will be provided two ultrasound scans to screen for pregnancy complications.
16122645|NCT01990911|Device|Renal denervation|In patients randomized to intervention both renal arteries will be treated with radio-frequency energy as per standard Symplicity protocol.In patients randomized to medical-treatment group only, sham renal denervation will be performed by only injecting contrast agent into both renal arteries.
16122646|NCT01990911|Drug|Medical therapy|Subjects will continue on their standard medical therapy as prescribed by their treating physician
16122647|NCT01990898|Drug|Cyclosporine|Drug will be provided to patient's at study visit. Drug is to be taken twice daily. Dosage will be calculated at study visit and provided to patient.
16122648|NCT01990885|Drug|BL-7010|
16122649|NCT01990885|Drug|Placebo|
16122650|NCT01990872|Dietary Supplement|Vitamin D3 (20 micrograms/day)|Vitamin D3 (20 micrograms/day)
16122651|NCT01990872|Dietary Supplement|Placebo|Placebo (0 micrograms vitamin D3/day)
16122652|NCT01990859|Biological|Ipilimumab|
16122653|NCT01990846|Drug|Flufirvitide 3|
16122654|NCT01990846|Drug|Placebo for Flufirvitide-3|
16122655|NCT01990820|Device|Acclarent Relieva Balloon Sinuplasty|"A rigid nasal endoscopy will be performed. After decongesting with oxymetazoline hydrochloride, the balloon catheter device will be inserted and the wire/balloon will be threaded through the maxillary sinus ostia. Confirmation of location will be per manufacturer's recommendation with either fluoroscopy or illumination. Following confirmation, the balloon will be dilated under visualization per manufacture's recommendation. After the visualization of the dilated ostia, cultures for aerobic/anerobic examination will be taken and irrigation with 10ml of isotonic sodium chloride will be performed.
~Adenoidectomy will be performed using either the microdebrider or suction electrocautery in the usual manner."
16122656|NCT01990820|Procedure|Adenoidectomy + Maxillary Sinus Irrigation|"A rigid nasal endoscopy will be performed. After decongesting with oxymetazoline hydrochloride, the maxillary sinuses will be entered via middle meati punctures using either a sterile spinal needle or a curved suction. Sinus contents will be aspirated and sent for aerobic/anaerobic cultures. Irrigation with 10ml of isotonic sodium chloride will be performed. If no material is aspirated initially, the sinus contents will be re-aspirated after irrigation and sent for aerobic/anaerobic cultures.
~Adenoidectomy will be performed using either the microdebrider or suction electrocautery in the usual manner.
~After adequate hemostasis, the patient will be awakened and brought to the recovery room. Depending on the recovery, the child will either be admitted or discharged home."
16122657|NCT01990807|Drug|Idarubicin(IDA)|6mg/M2 IV(in the vein) on day 16,22,29 of induction therapy, until progression or unacceptable toxicity develops.
16122658|NCT01990781|Drug|LD: Lidocaine and dexamethasone|LD: intravenous lidocaine 1.5 mg/kg and dexamethasone 8 mg before induction of anesthesia
16122659|NCT01990781|Drug|L:Lidocaine|Intravenous lidocaine 1.5 mg/kg before induction of anesthesia
16122660|NCT01990781|Drug|D: Dexamethasone|D:intravenous dexamethasone 8 mg before induction of anesthesia
16122661|NCT01990781|Drug|N: Normal saline (placebo)|Normal saline: 2ml
16122662|NCT01990768|Drug|1 gram Tranexamic Acid (TXA)|TXA produces an antifibrinolytic effect by competitively inhibiting the activation of plasminogen to plasmin.
16122663|NCT01990768|Drug|2 grams TXA|TXA produces an antifibrinolytic effect by competitively inhibiting the activation of plasminogen to plasmin.
16122664|NCT01990768|Drug|0.9% Sodium Chloride injectable|Loading dose of 0.9% Sodium Chloride solution given prior to hospital arrival followed by a placebo of 0.9% Sodium Chloride solution infusion over 8 hours after hospital arrival. No active drug is added to the solution.
16122665|NCT01990755|Behavioral|CBT (Cognitive Behavioral Therapy)|It is a worldwide known form of psychotherapy for eating disorders
16122666|NCT01990755|Other|IBPP (individual psychology brief psychotherapy)|It is a worldwide known form of psychotherapy for eating disorders
16122667|NCT01990755|Drug|CBT + OLANZAPINE|It is a worldwide known form of psychotherapy for eating disorders associated with a new antipsychotic with good efficacy on anorexia nervosa
16122668|NCT01990755|Dietary Supplement|nutritional rehabilitation|all patients were followed-up monthly with nutritionist and dietitian visits
16122669|NCT01990755|Drug|delorazepam|all patients were followed-up with psychiatric visits with symptomatic drug administration (tranquillizer: delorazepam) where necessary
16122670|NCT01990742|Behavioral|Palliative Care Team (PCTeam)|Palliative care teams will be established and will round with residents in the intervention nursing homes.
16122671|NCT01990729|Dietary Supplement|ARTRA|ARTRA (glucosamine and chondroitin sulfate)
16122672|NCT01990716|Other|Colonic Biopsy|"Colonoscopy or coloscopy can provide a visual diagnosis and grants the opportunity for biopsy or removal of suspected colorectal cancer lesions.
~The endoscope is then passed through the anus up the rectum, the colon, and ultimately the terminal ileum. The endoscope has a movable tip and multiple channels for instrumentation, air, suction and light. Biopsies are frequently taken for histology, needed for cancer or IBD diagnosis.
~Extra-biopsies for research purpose will only be performed if the clinician decides that they are necessary for the clinical diagnosis or for the disease follow-up.
~For this protocol, collecting these extra biopsies should last under 5 minutes and should not extend the procedure by more than this time."
16122673|NCT01990703|Drug|Levonorgestrel IUD|Timing of IUD insertion
16122674|NCT01990690|Drug|anti oxidant omega 3|"Soft gelatineous capsule (Sedico medical company) each capsule contains:
~Fish oil (30) % (Eicosapentaenoic acid (EPA) 18 % / Docosahexaenoic acid (DHA) 12 % ) natural source of Omega 3 Fatty acids.
~Wheat germ oil (Tocopherol: N.N.T. 0.22 %) which is rich and natural source of Vitamin E (protects the oils from oxidation. besides its well known that requirements of vitamin E increases with increased dietary amounts of polyunsaturated fatty acids).
~Group 1 was given omega -3 plus (Sedico medical company) as antioxidant once daily for two weeks."
16122675|NCT01990677|Drug|25mg Eplerenone|Patients will be given 25mg Eplerenone (or 50mg Eplerenone) or placebo throughout the study and the dosage will be based on the serum potassium/creatine levels. Patients will be randomized 2:1 such that 36 patients in each group will receive eplerenone and 16 patients in each group will receive placebo
16122676|NCT01990677|Drug|Placebo|Patients will be given placebo throughout the study from day one, other patients may be tapered down to placebo based on the serum potassium/creatine levels. 16 patients in each group will receive placebo.
16122677|NCT01990664|Device|senofilcon A|
16122678|NCT01990664|Device|senofilcon A for Astigmatism|
16122679|NCT01990638|Other|exercise capacity test|
16122811|NCT01989598|Drug|Uprosertib|Given PO
16122681|NCT01990612|Procedure|Elective Induction of Labor|Women randomized to induction of labor will undergo induction via oxytocin at 39 weeks 0 days to 39 weeks 4 days. Those with an unfavorable cervix (modified Bishop score < 5) will first undergo cervical ripening (method left to the discretion of the patient's physician) in conjunction with or followed by oxytocin stimulation unless a contraindication arises.
16122682|NCT01990599|Other|Nasopharyngeal Tube|
16122683|NCT01990586|Drug|Rabeprazole sodium 20 mg Delayed Release tablet|
16122684|NCT01990573|Drug|0.3mg/kg IV methadone HCl|Group I will receive 0.3mg/kg IV methadone HCl
16122685|NCT01990573|Drug|0.4mg/kg IV methadon HCl|Group II will receive 0.4mg/kg IV methadone HCl.
16122686|NCT01990573|Other|control no methadone|The control group will not receive methadone.
16122687|NCT01990560|Drug|Mifepristone|All patients in the study will receive daily Mifepristone for 6 months and primary and secondary outcomes will be assessed before and after the 6 month treatment period
16122688|NCT01990534|Drug|Brentuximab Vedotin|Brentuximab vedotin IV infusion
16122689|NCT01990521|Procedure|MS3TMRI / TRUS Guided Biopsy|Patients would undergo MS3TMRI and then have a transrectal ultrasound (TRUS) biopsy performed within one month after the MRI. The initial cores would be obtained using TRUS without MRI information (TRUSBx). During the same biopsy session, the MS3TMRI information would be given to the physician performing the biopsy and additional cores specifically targeted to suspicious areas would be performed (MS3TMRI-TRUSBx).
16122690|NCT01990521|Device|MS3TMRI / TRUS Guided Biopsy|"Multispectral 3T MRI (MS3TMRI) is a device that uses a 3T MRI system without an endorectal receiver coil and with a surface phased array coil. 3T MRI in addition to established computer aided diagnosis (CAD) has been used to perform guided biopsies in an active surveillance population and demonstrated a positive predictive value and negative predictive value of 83% and 81%.
~A recently completed a study looking at repeat prostate biopsies in men followed on an active surveillance population at Sunnybrook has shown that the PPV of MS3TMRI guided biopsy to be 85%, while the negative predictive value was 100% (Haider, Vesprini and Milot, unpublished)."
16122691|NCT01990508|Behavioral|Targeted beverage education and financial incentives|
16122692|NCT01990508|Behavioral|Traffic-light labeling of all beverages in store|All beverages in the supermarket will be labeled as red, yellow, or green
16122693|NCT01990495|Other|Exercise training|Subjects will participate in a center-based and home exercise training program for 3 months.
16122694|NCT01990495|Other|Usual Care|This group will serve as control subjects. They will receive only usual clinical care.
16122695|NCT01990482|Dietary Supplement|caffe|
16122696|NCT01990482|Dietary Supplement|Water|
16122697|NCT01990469|Drug|Gemigliptin|DPP-4 inhibitor
16122698|NCT01990469|Drug|Gemigliptin placebo|Placebo of Gemigliptin
16122699|NCT01990456|Device|PHASE 1: impact of tidal ventilation on VILI|PHASE 1A - Baseline - Standard Ventilation Protocol (PCV 10 cmH2O, PEEP 10 cmH2O, RR 10, FiO2 0.30) PHASE 1B - CPAP Strategy - CPAP 10 cmH2O for 1 hour PHASE 1C - Higher Tidal Ventilation Strategy (PCV 20 cmH2O, PEEP 10 cmH2O, RR 10, FiO2 0.30) PHASE 1D - Return to Baseline - Standard Ventilation Protocol
16122700|NCT01990456|Device|PHASE 2: impact of PEEP on VILI|PHASE 2A - Baseline - Standard Ventilation Protocol - (PCV 10 cmH2O, PEEP 10 cmH2O, RR 10, FiO2 0.30) PHASE 2B - Decremental PEEP Trial PHASE 2C - CPAP set at best compliance of respiratory system (as per decremental PEEP Trial) PHASE 2D - ZEEP PHASE 2E - Return to Baseline - Standard Ventilation Protocol
16122701|NCT01990443|Drug|Reslizumab IV|Reslizumab 220-mg intravenous (IV)
16122702|NCT01990443|Drug|Reslizumab SC|Reslizumab 220 mg administered subcutaneous (SC)
16122703|NCT01990430|Behavioral|Exercise Intervention|"Intervention: The sessions included instructions in training exercises, as well as included time to speak about their fears and doubts with other patients, who were in the same situation. The intervention lasted 12 weeks (24 sessions). The training intensity was progressively increased from 65% to 85% of heart rate with control by a POLAR FT7 heart rate monitor for aerobic activities, and by 8-15 repetitions in 2-3 sets for the strength activities. Exercise intensity was prescribed using Karvonen equation.
~The nutrition program consisted of three theoretical and practice classes. The first class explained the different groups of nutrients, their functions in the organism and for which group of aliments these can be obtained. The second class was a practical class about how to interpret food labels and relating measurements of food portions with recommendations for a healthy diet. Final session spoke about the ten best and the ten worst aliments, which prevent and promote cancer."
16122704|NCT01990417|Other|Passive stretching|Passive stretching of the hamstrings was performed only once, lasting 30 seconds, and initiated on the right leg. Participants were in supine position with head, trunk and arms aligned along the body. The researcher remained ipsilateral to the subject´s leg being stretched and applied external force to the limit tolerated by the participant. The researcher performed a hip flexion, knee extension, and dorsiflexion of the ankle while the opposite leg remained extended on the ground.
16122705|NCT01990404|Drug|Premixed 50% nitrous oxide and oxygen|Premixed 50% nitrous oxide and oxygen is a gas in cylinder of 5 litres delivered by a face mask. The gases of the study are contained in anonymous bottles of the same capacity. Bottles will only be differentiated by a letter: A or B.
16122706|NCT01990404|Drug|Medical Air|Medical air is a gas in cylinder of 5 litres delivered by a face mask. The gases of the study are contained in anonymous bottles of the same capacity. Bottles will only be differentiated by a letter: A or B
16122707|NCT01990391|Dietary Supplement|Brazil nut flour|The Brazil nut group received 13g/day of Brazil nut flour during three months.
16122708|NCT01990391|Dietary Supplement|Placebo (cassava flavored flour)|The group placebo (cassava flour flavored)received 9g/day of cassava flour flavored during three months
16122709|NCT01990378|Drug|Rabeprazole sodium 20 mg Delayed Release tablet|
16122710|NCT01990352|Drug|Pegylated liposomal doxorubicin|
16122711|NCT01990339|Drug|Lansoprazole|"• Reflux esophagitis The usual adult dosage is 30 mg of lansoprazole administered orally once daily for up to 8 weeks.
~For maintenance therapy of repeatedly recurring/relapsing reflux esophagitis, the dosage is 15 mg of lansoprazole administered orally once daily. If insufficient efficacy is observed, the dosage may be increased to 30 mg administered orally once daily.
~• Nonerosive gastroesophageal reflux disease Non-erosive gastroesophageal reflux disease The usual adult dosage is 15 mg of lansoprazole administered orally once daily for up to 4 weeks."
16122712|NCT01990326|Drug|XAF5 Gel|
16122713|NCT01990326|Drug|Placebo Gel|
16122714|NCT01990313|Device|Activa PC+S|The Model 37604 Activa PC+S is a multiprogrammable device that can deliver therapeutic electrical stimulation and record bioelectric signals from leads implanted in the brain.
16122715|NCT01990300|Drug|Alogliptin/Pioglitazone|Alogliptin/Pioglitazone combination tablets
16122716|NCT01990287|Device|SCS and PNfS|Spinal Cord Stimulation (SCS) in combination with Peripheral Nerve Field Stimulation (PNfS). The SCS leads will be placed in the Thoracolumbar region and the PNfS lead will be placed subcutaneously in the area of pain.
16122717|NCT01990287|Device|SCS Alone|Spinal Cord Stimulation (SCS) only. The SCS leads will be placed in the Thoracolumbar region only.
16122718|NCT01990274|Procedure|GeneXpert MTB/RIF assay|Automated nucleic-acid amplification test (fully integrated) test for TB
16122719|NCT01990274|Procedure|Smear microscopy|Smear microscopy involve sputum smear with either ziehl-neelsen or auramine-O staining of slides and light or fluorescence microscopy reading
16122720|NCT01990261|Drug|Erlotinib|Erlotinib at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
16122721|NCT01990235|Behavioral|PREPARE Intervention|At week 1, 3, 6, and 12 months, interviews (telephone or in person based on preference) by blinded staff will assess engagement in advance care planning(ACP), self-efficacy with ACP, and activation in and satisfaction with decision making. Blinded telephone interviews will also assess surrogate reports of patient engagement in ACP.
16122722|NCT01990209|Drug|Orteronel|
16122723|NCT01990196|Drug|degarelix|"Every 4-week Treatment: A starting dose of 240 mg of Degarelix is taken subcutaneously (SQ) -placed under the skin by injection- the first month. Doses continue every 4 weeks at 80 mg SQ.
~Dose for a drug may have to be modified based on development of adverse events on a case by case basis as per the judgment of treating physician."
16122724|NCT01990196|Drug|enzalutamide|"Once Daily Treatment: A starting dose of 160 mg of Enzalutamide is taken by mouth once daily.
~Dose for a drug may have to be modified based on development of adverse events on a case by case basis as per the judgment of treating physician."
16122725|NCT01990196|Drug|trametinib|"Once Daily Treatment: If randomized into Group 2, then 2mg of Trametinib is taken by mouth daily.
~Dose for a drug may have to be modified based on development of adverse events on a case by case basis as per the judgment of treating physician"
16122726|NCT01990196|Drug|dasatinib|"Once Daily Treatment: If randomized into Group 3, then 100mg of Dasatinib is taken by mouth daily.
~Dose for a drug may have to be modified based on development of adverse events on a case by case basis as per the judgment of treating physician"
16122727|NCT01990183|Device|CareToy|Infants randomized in the Intervention Group will begin the habilitation intervention immediately after evaluation at baseline. Rehabilitation staff, in accordance with each infant's needs and clinical characteristics, will set up the CareToy System to perform individualized intervention packages and its user's manual. So a personalized CareToy System will be delivered at infant's home. Moreover parents will attend a training course to use it. During each daily home - session (about 30 - 45 minutes overall) it will be proposed to the child various interactive activities in supine, prone and sitting position. The intervention phase lasts 4 weeks and each session will be remotely monitored by the rehabilitation staff.
16122728|NCT01990183|Other|Standard Care|Current care advices in the management of preterm infants in the first months of life
16122729|NCT01990157|Drug|TAB08|Weekly intravenous administration in escalating doses.
16122730|NCT01990144|Drug|Bendamustine+Rituximab|"Patients will receive :
~Rituximab 375 mg/m2 intravenously on day 1*
~Bendamustine 90 mg/m2 intravenously on days 2 and 3** Treatment will be administered on a 28-day cycle basis.
~Administration of rituximab during cycle 1 is postponed to day 8, thereafter on day 1.
~After the first cycle, bendamustine can be administered on days 1-2 or days 2-3 according to Institutional/patient/physician choice."
16122731|NCT01990131|Other|Cognitive Anxiety Sensitivity Treatment|
16122732|NCT01990131|Other|Physical Health Education Training|
16122733|NCT01990118|Drug|Neoral|Neoral® capsule containing 25mg or 100mg cyclosporine
16122734|NCT01990118|Drug|Gengraf® capsule containing 25mg or 100mg cyclosporine|Transplant patients who were stable on Neoral were converted to Gengraf
16122735|NCT01990092|Other|Metanx|Metanx is a prescription medical food.
16122736|NCT01990092|Other|Placebo|
16122737|NCT01990079|Drug|Bupropion|All participants who are medically eligible will be prescribed bupropion, which they will start two weeks prior to their quit day. Dosage will be 150 mg/daily for days 1-7 and 300 mg/daily (administered in two daily doses) until the 3-month follow-up.
16122738|NCT01990079|Drug|nicotine replacement therapy|Participants will be prescribed NRT patch and one nicotine rescue method (e.g., nicotine gum, lozenge, inhaler) for use during the post-quit phase of the study. Participants will be given the choice between nicotine gum, nicotine inhaler, or nicotine nasal spray, and will be instructed to use the rescue method as needed to reduce cigarette cravings
16122739|NCT01990079|Other|Smoking cessation counseling|Participants will receive four 20-minute smoking cessation counseling sessions and a participant manual. The four sessions are based on standard cognitive-behavioral therapy techniques shown to be efficacious for smoking cessation.
16122740|NCT01990079|Behavioral|mobile contingency management|Participants will be asked to provide video recordings of themselves taking carbon monoxide readings in order to confirm smoking abstinence. Participants are asked to upload these videos to the study's secured server, and are provided monetary reward for videos that suggest smoking abstinence.
16122741|NCT01990079|Other|Stay Quit Coach|Stay Quit Coach is a smart phone application that serves as a source of readily available support and information for adults who are already in treatment to quit smoking and to help them stay quit after treatment. The app guides user in creating tailored plans that include their personal reasons for quitting, interactive tools to help users cope with urges to smoke, motivational messages, support contacts to help users stay smoke free and how to address lapses. Participants assigned to this condition will be asked to use Stay Quit Coach from Session 2 through the 6-month follow-up.
16122742|NCT01990066|Behavioral|Home Based Exercise|Subjects randomized to intervention will receive Physical Therapist instructed exercise teaching. They will receive a home exercise DVD and flip ring of exercises. Subjects will be asked to perform home exercise 3 days weekly consisting of 13 strengthening/stretching exercises and 20 mins of aerobic exercise, walking or seated aerobics using ergometer. Subjects will record their exercise on a log and return on day 1 of every cycle.
16122920|NCT01988805|Other|Blood Draw|
16122743|NCT01990053|Behavioral|Beating the Blues|The BtB program guides patients through a series of 8 fully automated online lessons intended to help them identify and change problematic patterns of thinking and behavior that maintain depression. Support will be provided by licensed professional therapists over the phone or via email.
16122744|NCT01990001|Other|enrollment in online reminder system|Study personnel enrolled members in the online reminder system during their office visit.
16122745|NCT01989988|Procedure|LMGB|
16122746|NCT01989988|Procedure|LRYGB|
16122747|NCT01989988|Procedure|SADJB|
16122748|NCT01989962|Other|E4E intervention|The E4E intervention consists of a one-day face-to-face workshop and a series of follow-up online learning modules. Workshop and online content will be tailored to meet individual participants' needs determined by a pre-program needs assessment. E4E intervention will emphasize clinically based case scenarios and are designed to reinforce the workshop concepts and stimulate reflection. Participating family physicians will attend the workshop and engage in reflections and small-group interactions.
16122749|NCT01989949|Drug|TP-434 (Eravacycline) reconstituted and administered via an IV infusion|
16122750|NCT01989936|Drug|Placebo|Subjects were randomized to one of the 3 treatment groups (eletriptan 40 mg, eletriptan 80 mg, or placebo) in a 2:2:1 ratio and were given sufficient medication to treat 3 migraine attacks (including a second dose for each attack for recurrence) within 18 weeks of the initial visit. Subjects were instructed to treat a moderate to severe migraine within 6 hours of the onset of pain provided the headache was not decreasing in severity, the aura phase had ended and they had taken no analgesic or antiemetic within 6 hours. Efficacy data was collected in a diary. Subjects were allowed to take rescue medication if they had no response to the study medication within 4 hours of onset.
16122751|NCT01989936|Drug|Eletriptan 40 mg|Subjects were randomized to one of the 3 treatment groups (eletriptan 40 mg, eletriptan 80 mg, or placebo) in a 2:2:1 ratio and were given sufficient medication to treat 3 migraine attacks (including a second dose for each attack for recurrence) within 18 weeks of the initial visit. Subjects were instructed to treat a moderate to severe migraine within 6 hours of the onset of pain provided the headache was not decreasing in severity, the aura phase had ended and they had taken no analgesic or antiemetic within 6 hours. Efficacy data was collected in a diary. Subjects were allowed to take rescue medication if they had no response to the study medication within 4 hours of onset.
16122752|NCT01989936|Drug|Eletriptan 80 mg|Subjects were randomized to one of the 3 treatment groups (eletriptan 40 mg, eletriptan 80 mg, or placebo) in a 2:2:1 ratio and were given sufficient medication to treat 3 migraine attacks (including a second dose for each attack for recurrence) within 18 weeks of the initial visit. Subjects were instructed to treat a moderate to severe migraine within 6 hours of the onset of pain provided the headache was not decreasing in severity, the aura phase had ended and they had taken no analgesic or antiemetic within 6 hours. Efficacy data was collected in a diary. Subjects were allowed to take rescue medication if they had no response to the study medication within 4 hours of onset.
16122753|NCT01989923|Other|Nicotine Replacement Therapy|Patients will use one patch per day for 6 weeks for a total of 42 patches - they will receive 7 the first visit and then the additional 35 at the second visit. Women will receive 3 weeks of original strength nicotine patches, and will receive patches half as strong during the last 3 weeks of the study. This will allow for a lower strength of nicotine as each woman continues with smoking cessation.
16122754|NCT01989923|Device|Electronic Cigarettes|The number of cartridges for the electronic cigarettes is determined by asking each patient the number of packs currently smoked per day, and multiplying 1.5 times the number of packs smoked per day. We plan to decrease the strength of the cartridges by one half after three weeks of intervention. We will give each women supplies and instructions accordingly. This will allow for a lower strength of nicotine as each woman continues with smoking cessation
16122755|NCT01989910|Drug|Raltegravir|Raltegravir 400mg oral twice daily
16122756|NCT01989910|Drug|Efavirenz|Efavirenz 600mg oral at bedtime
16122759|NCT01989884|Drug|Ortataxel|75 mg/m2, IV (in the vein) every 21 days. Number of Cycles: until progression or unacceptable toxicity develops.
16122760|NCT01989871|Behavioral|Adjusted individual feeding|Feeding every 2-4 hours, starting with ques of hunger and finished upon infant signs.
16122761|NCT01989858|Other|peri-operative cht|"CHT treatment have to be chosen between the following associations:
~Chemotherapy regimen containing epirubicin, cisplatin and capecitabine (EOX) E: epirubicin 50 mg/m² intravenous (iv) bolus, day 1 every 3 weeks O: oxaliplatin 130 mg/m² iv infusion, day 1 in 2-3 hours every 3 weeks X: capecitabine 625 mg/m² bis in die (bid), day 1 per os (po) continuously
~or
~Chemotherapy regimen containing epirubicin, cisplatin and 5-fluorouracil (ECF) E: epirubicin 50 mg/m² iv bolus, day 1 every 3 weeks C: cisplatin 60 mg/m² iv with standard hydration day 1 every 3 weeks F: 5FU 200 mg/m² daily by continuous infusion via central line."
16122762|NCT01989858|Other|post-operative CHT|"CHT treatment have to be chosen between the following associations:
~EOX E: epirubicin 50 mg/m² intravenous (iv) bolus, day 1 every 3 weeks O: oxaliplatin 130 mg/m² iv infusion, day 1 in 2-3 hours every 3 weeks X: capecitabine 625 mg/m² bis in die (bid), day 1 per os (po) continuously
~or ECF E: epirubicin 50 mg/m² iv bolus, day 1 every 3 weeks C: cisplatin 60 mg/m² iv with standard hydration day 1 every 3 weeks F: 5fluorouracil (5FU) 200 mg/m² daily by continuous infusion via central line."
16122763|NCT01989858|Other|peri-operative cht + post-operative cht-rtx|"CHT treatment have to be chosen between the following associations:
~EOX E: epirubicin 50 mg/m² intravenous (iv) bolus, day 1 every 3 weeks O: oxaliplatin 130 mg/m² iv infusion, day 1 in 2-3 hours every 3 weeks X: capecitabine 625 mg/m² bis in die (bid), day 1 per os (po) continuously or
~ECF E: epirubicin 50 mg/m² iv bolus, day 1 every 3 weeks C: cisplatin 60 mg/m² iv with standard hydration day 1 every 3 weeks F: 5FU 200 mg/m² daily by continuous infusion via central line.
~The prescribed RTX dose to clinical target volume should be 45 gray (Gy) delivered in daily fraction of 1.8 Gy, five times per week for six weeks. RTX will be administered concurrently with CHT. The choice of the associated CHT should be between the following schedules:
~5FU 225 mg/m² given as a continuous iv infusion or
~capecitabine 825 mg/m² bid given as a continuous oral administration during the entire course of RTX."
16122764|NCT01989858|Other|post-operative cht + post-operative cht-rtx|"CHT treatment have to be chosen between the following associations:
~EOX E: epirubicin 50 mg/m² intravenous (iv) bolus, day 1 every 3 weeks O: oxaliplatin 130 mg/m² iv infusion, day 1 in 2-3 hours every 3 weeks X: capecitabine 625 mg/m² bis in die (bid), day 1 per os (po) continuously or
~ECF E: epirubicin 50 mg/m² iv bolus, day 1 every 3 weeks C: cisplatin 60 mg/m² iv with standard hydration day 1 every 3 weeks F: 5FU 200 mg/m² daily by continuous infusion via central line.
~The prescribed RTX dose to clinical target volume should be 45 gray (Gy) delivered in daily fraction of 1.8 Gy, five times per week for six weeks. RTX will be administered concurrently with CHT. The choice of the associated CHT should be between the following schedules:
~5FU 225 mg/m² given as a continuous iv infusion or
~capecitabine 825 mg/m² bid given as a continuous oral administration during the entire course of RTX."
16122765|NCT01989845|Drug|Rivaroxaban|Rivaroxaban 15mg twice daily for the first 3 weeks, followed by 20mg once daily during 6 months
16122766|NCT01989819|Other|skin biopsy|
16122767|NCT01989806|Device|Robotic-assisted body weight supported treadmill training (Lokomat V6, Hocoma AG, Switzerland)|
16122768|NCT01989806|Device|Passive lower limbs mobilization training (Motomed Vivo 2, RECK, Germany)|
16122769|NCT01989793|Drug|Losartan|Losartan will be given in increasing doses to those in the losartan arm.
16122770|NCT01989793|Drug|Placebo|Placebo will be given to those in placebo arm
16122771|NCT01989780|Drug|Paclitaxel|
16122772|NCT01989780|Drug|Bevacizumab|
16122773|NCT01989780|Drug|Letrozole|
16122774|NCT01989780|Drug|Anastrozole|
16122775|NCT01989780|Drug|Exemestane|
16122776|NCT01989780|Drug|Fulvestrant|
16122777|NCT01989780|Drug|Goserelin|
16122778|NCT01989780|Drug|leuprorelin|
16122779|NCT01989780|Drug|LHRH Analogs + Aromatase inhibitors|
16122780|NCT01989767|Behavioral|control Rehabilitation as usual|Rehabilitation as usual
16122781|NCT01989767|Behavioral|education|Education as add on to to rehabilitation as usual
16122782|NCT01989754|Drug|Placebo|One placebo capsule taken orally (by mouth) once daily for 156 weeks
16122783|NCT01989754|Drug|Canagliflozin, 100 mg|One 100 mg capsule taken orally (by mouth) once daily
16122784|NCT01989754|Drug|Canagliflozin, 300 mg|One 300 mg capsule taken orally (by mouth) once daily
16122785|NCT01989741|Other|Sleep restriction|4 hours sleep by night during one week
16122786|NCT01989728|Procedure|psychiatric examination and feedback|
16122787|NCT01989715|Other|analyzing the position of the body, muscle activity|
16122788|NCT01989702|Other|Fermented blueberry drink|
16122789|NCT01989702|Other|Placebo drink|
16122790|NCT01989702|Other|Sachets with probiotic bacterial powder|
16122791|NCT01989702|Other|Sachets with placebo powder|
16122792|NCT01989689|Drug|Etanercept|Etanercept 50mg twice weekly
16122793|NCT01989689|Drug|Placebo|
16122794|NCT01989676|Biological|PF-05280014|Concentrate for solution for infusion, sterile vial 150 mg. Initial dose of 4 mg/kg over 90 minutes (depending on tolerability) IV infusion, then 2 mg/kg over 30 to 90 minutes (depending on tolerability) IV infusion until disease progression. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the PF-05280014 regimen may be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
16122795|NCT01989676|Drug|Paclitaxel|A nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel. The starting dose of paclitaxel will be 80 mg/m^2 by IV infusion over 60 minutes (duration of infusion may be modified according to local standard of care, if applicable). Provision is made for dose reduction to 70 mg/m^2 and then 60 mg/m^2 as needed. In the absence of disease progression in the judgment of the investigator or prohibitive toxicity, patients will receive treatment with paclitaxel for at least 6 cycles or until maximal benefit of response is obtained, in the judgment of the investigator.
16122796|NCT01989676|Biological|Herceptin®|Concentrate for solution for infusion, sterile vial 150 mg. Initial dose of 4 mg/kg over 90 minutes (depending on tolerability) IV infusion, then 2 mg/kg over 30 to 90 minutes (depending on tolerability) IV infusion weekly until disease progression. Following completion of the paclitaxel administration period and beginning no earlier than Week 33 of the study, the Herceptin® regimen may be changed at the discretion of the investigator to every 3 weeks at a dose of 6 mg/kg infused over 30 to 90 minutes depending on tolerability.
16122797|NCT01989676|Drug|Paclitaxel|A nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel is available in 30 mg (5 mL), 100 mg (16.7 mL), and 300 mg (50 mL) multidose vials. Each mL of sterile nonpyrogenic solution contains 6 mg paclitaxel. The starting dose of paclitaxel will be 80 mg/m^2 by IV infusion over 60 minutes (duration of infusion may be modified according to local standard of care, if applicable). Provision is made for dose reduction to 70 mg/m^2 and then 60 mg/m^2 as needed. In the absence of disease progression in the judgment of the investigator or prohibitive toxicity, patients will receive treatment with paclitaxel for at least 6 cycles or until maximal benefit of response is obtained, in the judgment of the investigator.
16122798|NCT01989663|Drug|1% vaginally applied tenofovir gel|
16122799|NCT01989663|Drug|Tenofovir film- 10mg|
16122800|NCT01989663|Drug|Tenofovir Film-40 mg|
16122801|NCT01989663|Other|HEC Placebo Gel|
16122802|NCT01989663|Other|Placebo Vaginal Film|
16122803|NCT01989650|Other|Break|A break of 15 minute will be provided after 3rd colonoscopy in a session of 6 colonoscopies in total
16122804|NCT01989650|Other|No break|No break will be provided
16122805|NCT01989637|Dietary Supplement|Strawberry Meal|High-fat meal (50 g total fat) with 40 g freeze dried strawberry powder
16122806|NCT01989637|Dietary Supplement|Control Meal|High-fat meal (50 g total fat) with a matched placebo powder containing no strawberry bioactives
16122807|NCT01989611|Drug|emtricitabine / tenofovir 200/300 mg|Fixed dose combination of emtricitabine / tenofovir 200/300 mg once daily orally during one year
16122808|NCT01989598|Other|Laboratory Biomarker Analysis|Correlative studies
16122809|NCT01989598|Other|Pharmacological Study|Correlative studies
16122810|NCT01989598|Drug|Trametinib|Given PO
16122818|NCT01989572|Other|Placebo|Given GM-CSF placebo SC
16122819|NCT01989572|Other|Placebo|Given peptide placebo SC
16122820|NCT01989572|Biological|Sargramostim|Given SC
16122821|NCT01989572|Biological|Tyrosinase Peptide|Given SC
16122822|NCT01989559|Biological|gp100:209-217(210M) Peptide Vaccine|Given SC
16122823|NCT01989559|Biological|HPV 16 E7:12-20 Peptide Vaccine|Given SC
16122824|NCT01989559|Other|Laboratory Biomarker Analysis|Correlative studies
16122825|NCT01989546|Drug|BMN 673|Poly (ADP-ribose) polymerase (PARP) inhibitor; has been shown to cause single-agent synthetic lethality in breast cancer 1 and breast cancer 2 (BRCA1/2)- and phosphatase and tensin homolog (PTEN)-deficient cell lines, and has potent antitumor activity in animal models of tumors harboring mutations in deoxyribonucleic acid (DNA) repair pathways.
16122826|NCT01989533|Biological|Ad4-mgag|Ad4 live virus vaccine with an HIV insert
16122827|NCT01989533|Biological|Ad4-EnvC150|Ad4 live virus vaccine with an HIV insert
16122828|NCT01989533|Biological|gp 120 Protein Boost|HIV protein boost
16122829|NCT01989520|Drug|Phase IIb formulation|Single oral dose 45mg AZD5069
16122830|NCT01989520|Drug|Putative phase III formulation|Single oral dose 45mg AZD5069
16122831|NCT01989520|Drug|Slow dissolution variant 1|Single oral dose 45mg AZD5069
16122832|NCT01989520|Drug|Slow dissolution variant 2|Single oral dose 45mg AZD 5069
16122833|NCT01989520|Drug|Test treatment E|Tablet formulation E, 45 mg (intermediate dissolution variant) of AZD5069
16122834|NCT01989507|Drug|Nicotine|
16122835|NCT01989507|Behavioral|behavioral counseling for smoking cessation|Brief session of Brief advice. Assess smoking and provide assistance with quitting via coping skills.
16122836|NCT01989494|Device|Pedometer|All groups will receive a pedometer to measure their daily steps
16122837|NCT01989468|Biological|Secukinumab|Secukinumab 150 mg provided in a 1 mL autoinjector (1 autoinjector for 150 mg dose, 2 autoinjectors for 300 mg dose)
16122838|NCT01989468|Biological|Placebo|Secukinumab placebo provided in 1 mL autoinjector
16122839|NCT01989455|Drug|Deferiprone|"Deferiprone for infusion, 10mg/mL for intravenous infusion.
~Oral dose of deferiprone: 80mg/mL oral solution. (Cohort 2)"
16122840|NCT01989455|Drug|Placebo|Placebo: normal saline solution.
16122841|NCT01989442|Device|binasal prongs|patients randomized to binasal prongs for NIV will use binasal prongs as an interface during continuous positive airway pressure support
16122842|NCT01989442|Device|nasal mask|patients randomized to nasal mask for NIV will use nasal mask as an interface during continuous positive airway pressure support
16122843|NCT01989429|Drug|M518101|8-week comparative treatment period ( twice daily application) followed by a maximum 8-week period to evaluate time to relapse
16122844|NCT01989416|Drug|2% chlorhexidine wipe|The ICU patients will be bathing with 2% chlorhexidine wipe
16122845|NCT01989416|Drug|Soap|The ICU patients will be bathing with Soap
16122846|NCT01989403|Other|herbal medicine, acupuncture, bee-venom acupuncture, and Chuna manipulation|
16122847|NCT01989325|Drug|Carfilzomib, proteasome inhibitor; intravenous|multiple dose, single schedule
16122848|NCT01989325|Drug|Filanesib, KSP(Eg5) inhibitor; intravenous|multiple dose, single schedule
16122849|NCT01989325|Drug|Dexamethasone, steroid; oral or intravenous|as indicated, per the carfilzomib prescribing information
16122850|NCT01989325|Drug|Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous|standard of care
16122851|NCT01989312|Procedure|intravenous cannulation.|A 18-or 20-gauge intravenous (iv) catheter was placed to the contralateral arm according to the surgical site
16122852|NCT01989312|Procedure|Supraclavicular block and ultrasound-guided ulnar, median and radial nerve blocks.|Supraclavicular block with 20 mL of lidocaine 1.5% + epinephrine 5µg/mL and the addition of ultrasound-guided ulnar, median and radial nerve blocks. For that 12 mL of local anesthetic solution of a 50:50 mixture of lidocaine 2% and levobupivacaine 0.5% (4 mL/nerve) was used.
16122853|NCT01989312|Device|Intravenous cannulation.|A 18-or 20-gauge intravenous (iv) catheter was placed to the contralateral arm according to the surgical site
16122854|NCT01989312|Device|Routine ASA monitoring|Monitorization with ECG, noninvasive blood pressure and spO2.
16122855|NCT01989312|Drug|Premedication midazolam|Premedication with 0.03 mg/kg midazolam iv
16122856|NCT01989312|Drug|Lidocaine|
16122857|NCT01989312|Drug|Epinephrine|
16122858|NCT01989312|Drug|Levobupivacaine|
16122859|NCT01989299|Device|ILR implantation|
16122860|NCT01989286|Other|Assessment|The posture, motor development and balance are going to be assessed.
16122861|NCT01989273|Device|Ultrasound of inferior vena cava|
16122862|NCT01989260|Device|Anti-adhesive gel|4mls of anti-adhesive gel coated to the randomized ovary
16122863|NCT01989247|Behavioral|Self-management programme|Seven weekly group-based sessions for people with anxiety and depressive symptoms
16122864|NCT01989234|Drug|YKP10811|
16122865|NCT01989234|Drug|Placebo|
16122866|NCT01989221|Drug|Sancuso®|Sancuso® (granisetron transdermal system) 3.1 mg/24 hours
16122867|NCT01989208|Other|SG1002|200 mg capsules will be administered BID for 7 days, then doubled to 2 capsules BID for 7 days and doubled again to 4 capsules BID for the final 7 days.
16122868|NCT01989208|Other|Placebo|200 mg capsules containing placebo will be administered BID for 7 days, then doubled to 2 capsules BID for 7 days and doubled again to 4 capsules BID for the final 7 days.
16122869|NCT01989195|Drug|'SEEMORE' - MANGANESE-ENHANCED MRI CONTRAST REAGENT|"EACH SUBJECT UNDERWENT 2 CARDIAC MRI PROCEDURES: ONE WITH MAGNEVIST (GADOLINIUM), ONE WITH SEEMORE (MANGANESE) REAGENT
~CARDIAC MRI USING STANDARD DOSE OF 0.2mMOL/KG MAGNEVIST IV (IN THE VEIN)
~CARDIAC MRI USING SEEMORE REAGENT, DOSE: 0.35CC/KG IV (IN THE VEIN) 1 WEEK AFTER GADOLINIUM MRI"
16122870|NCT01989182|Device|Spiration Valve System|
16122871|NCT01989182|Other|Medical Management|
16122872|NCT01989169|Drug|Midazolam|
16122873|NCT01989169|Drug|SSP-004184SS|
16122874|NCT01989156|Other|THS 2.2 Menthol (mTHS 2.2)|THS 2.2 Menthol ad libitum for 5 days in confinement prolonged by 86 days in an ambulatory setting
16122875|NCT01989156|Other|Menthol Conventional Cigarette (mCC)|Subject's own preferred brand of mCC ad libitum for 5 days in confinement prolonged by 86 days in an ambulatory setting
16122921|NCT01988792|Dietary Supplement|Human milk fortifiers|
16122876|NCT01989156|Other|Smoking Abstinence (SA)|SA for 5 days in confinement prolonged by 86 days in an ambulatory setting
16122877|NCT01989143|Drug|PF-06480605|Subjects will receive single intravenous doses of 1, 3, 10, 30, 100, 300, 600 or 800 mg of PF-06480605 solution in a dose escalation format.
16122878|NCT01989143|Drug|Placebo|Subjects will receive single intravenous doses of PF-06480605 matching placebo solution in a dose escalation format.
16122879|NCT01989143|Drug|PF-06480605|Subjects will receive three subcutaneous doses of 30, 100, or 300 mg of PF-06480605 solution in a dose escalation format of one dose every 2 weeks (q2wk).
16122880|NCT01989143|Drug|Placebo|Subjects will receive three subcutaneous doses of PF-06480605 matching placebo solution in a dose escalation format of one dose every 2 weeks (q2wk).
16122881|NCT01989143|Drug|PF-06480605|Subjects will receive three intravenous doses of 500 mg of PF-06480605 solution in a dose escalation format of one dose every 2 weeks (q2wk).
16122882|NCT01989143|Drug|Placebo|Subjects will receive three intravenous doses of PF-06480605 matching placebo solution in a dose escalation format of one dose every 2 weeks (q2wk).
16122883|NCT01989130|Device|Roche AMPLICOR CT/NG|
16122884|NCT01989130|Device|Cepheid Xpert CT/NG Test|
16122885|NCT01989091|Device|B-Lock|Antimicrobial Catheter Lock Solution
16122886|NCT01989091|Drug|Heparin 5,000 U/mL|Standard of Care Catheter Lock Solution
16122887|NCT01989078|Drug|Losartan|"Adults and Children >50 kg:
~Those with systolic blood pressure (SBP) ≥ 100 mm Hg at entry will start with 50 mg of oral losartan once daily. At the week 2 visit, losartan will be increased to 100 mg daily.
~Those with SBP <100 mm Hg at entry will start with 25 mg of oral losartan once daily. Participants will return after 1 week for titration to 50 mg daily, if tolerated (i.e. SBP not lower than pre-losartan measurement by 10 mm Hg or more), and after 2 weeks to monitor blood pressure.
~Children <50 kg weight:
~Treatment will start with 25 mg oral Losartan once daily given as a morning dose. At the 2 week visit, Losartan will be increased to 50 mg daily. The dose will be increased to 100 mg once a body weight of 50 kg is achieved."
16122888|NCT01989065|Behavioral|Lifestyle counseling|see arm description
16122889|NCT01989065|Behavioral|Text Messaging|See Arm Description
16122890|NCT01989052|Drug|CTO|
16122891|NCT01989052|Drug|Lomustine|
16122892|NCT01989026|Biological|BCG|
16122893|NCT01989013|Other|biweekly intervention|10 step craniosacral therapy protocol through manual therapy at feet , thoracic diaphragm, neck and cranium
16122894|NCT01989000|Drug|Gadobutrol|0.1 ml/kg Gadovist is administered at 5 ml/s followed by a 15 ml saline flush
16122895|NCT01989000|Drug|[F-18]HX4|400 MBq [F-18]HX4, is administered in a single intravenous bolus injection, followed by a saline flush.
16122896|NCT01989000|Drug|Gemcitabine|1000 mg/m2/dose on day 1 and 8 in 2 cycles of 21 days (three weeks) each, one cycle before and one cycle after radiochemotherapy. During radiotherapy gemcitabine is administered at 1000 mg/m2/dose on day 1, 8 and 15.
16122897|NCT01989000|Radiation|Radiotherapy|A hypofractionated scheme of 15 fractions of 2.4 Gy in three weeks will be applied, combined with the second course of gemcitabine.
16122898|NCT01989000|Procedure|Pancreaticoduodenectomy|
16122899|NCT01988987|Other|Inpatient Postpartum GTT|Women with gestational diabetes will undergo a 75 gram, 2 hour, oral glucose tolerance test 2-4 days postpartum prior to hospital discharge, in addition to undergoing the standard of care, outpatient glucose tolerance test performed 6-12 weeks postpartum
16122900|NCT01988974|Behavioral|Alert for Atrial Fibrillation Program|Participants' baseline knowledge of AF symptoms, and attitudes and beliefs about AF will be assessed using the KABAFS, and patients will receive cognitive-behavioral training directed toward survey responses associated with delay of treatment. Training will incorporate the content developed by the American College of Cardiology Foundation (ACCF), and participants will receive education about how to recognize an irregular pulse, and how to record the pulse rhythm in a daily log. The PI/RN coordinator will review the completed KABAFS to assess knowledge deficits, and identify attitudes and beliefs about AF that may hinder early treatment-seeking.
16122901|NCT01988974|Behavioral|Healthy Sleep|Participants will receive a 45 minute face to face instruction about sleep hygiene
16122902|NCT01988961|Biological|Golimumab|SC injections
16122903|NCT01988948|Other|Various biological sampling|
16122904|NCT01988935|Behavioral|Prolonged Exposure|Weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders.
16122905|NCT01988935|Behavioral|Smoking Cessation|Weekly smoking cessation counseling (cognitive behavioral therapy) plus the nicotine patch to reduce withdrawal symptoms.
16122906|NCT01988922|Drug|ketamine|0.4 mg/kg oral racemic ketamine
16122907|NCT01988909|Drug|WR 279,396|Paromomycin + Gentamicin Topical Cream
16122908|NCT01988896|Drug|Atezolizumab|Atezolizumab will be administered at a fixed dose as specified via IV infusion.
16122909|NCT01988896|Drug|Cobimetinib|Cobimetinib will be administered orally at an escalating dose during Stage 1 and at RP2D during Stage 2.
16122910|NCT01988883|Drug|Placebo|Locking gelatin capsules filled with microcrystalline cellulose
16122911|NCT01988883|Drug|Modafinil|Modafinil is a wakefulness-promoting or psychostimulant drug. It will be administered as a single 200 mg oral tablet.
16122912|NCT01988883|Drug|Propranolol|Propranolol is a non-selective beta adrenergic antagonist.It will be administered as a single 20 mg oral tablet.
16122913|NCT01988870|Radiation|Intra-operative Radiation Therapy (IORT)|IORT is a form of APBI (accelerated partial breast irradiation) that allows for a high degree of dose homogeneity, exclusion of non-affected structures, and reduction of the volume of breast tissue exposed.
16122914|NCT01988857|Biological|Boostrix™|Single-dose administered intramuscularly in the deltoid region of non-dominant arm.
16122915|NCT01988844|Other|Assessment|The children with cerebral palsy were assessed. Different measures evaluating the upper limbs functionality are used.
16122916|NCT01988831|Drug|Propranolol hydrochloride|This intervention apply to Propranolol group
16122917|NCT01988831|Drug|Placebo pill|We use placebo pills alike propranolol commercial pills to ensure blindness of the subjects during the study.
16122918|NCT01988818|Device|Mepilex® Border Post-Op|wound dressing with Mepilex® Border Post-Op with Safetac®Technology, self-adherent soft silicone surgical dressing
16122919|NCT01988818|Device|standard wound dressing|standard wound dressing after hip-knee or spinal surgery
16122923|NCT01988779|Drug|nebulized levofloxacin|
16122924|NCT01988714|Other|(TCT) plus evidence-based SE|Targeted cognitive computer training (TCT) plus evidence-based SE in a community setting
16122925|NCT01988714|Other|(CG) plus evidence-based SE|(CG) plus evidence-based SE
16122926|NCT01988701|Other|Ancillary-Correlative|Blood samples are analyzed for activation status of B lymphocytes, T lymphocytes, and NK lymphocytes via flow cytometry, ELISA, ELISPOT, immunoblot, and microarray assays.
16122927|NCT01988688|Device|Deep Brain Stimulation (DBS)|Deep Brain Stimulation (DBS) bilaterally in area LC.
16122928|NCT01988675|Radiation|Whole Brain Irradiation|
16122929|NCT01988675|Radiation|Partial Brain Irradiation|
16122930|NCT01988675|Behavioral|Neuropsychological Testing|
16122931|NCT01988675|Behavioral|Quality of Life Questionnaire|
16122932|NCT01988675|Device|Magnetic Resonance Imaging (MRI) Assessments|MRI Assessments include Diffusion Tensor Imaging (DTI)and Gd-DTPA (Diethylenetriamine Pentaacetic Acid - a radioactive tracer injected into the patient and viewed on images).
16122933|NCT01988662|Procedure|Neovascular Age-related Macular Degeneration|Blood measurement
16122934|NCT01988649|Drug|Intranasal Oxytocin|Administration of intranasal Oxytocin
16122935|NCT01988649|Drug|Placebo (saline)|Administration of normal saline intranasally.
16122936|NCT01988636|Biological|PfSPZ Vaccine|Aseptic, purified, vialed, cryopreserved, radiation attenuated NF54 p.falciparum sporozoites produced by Sanaria, Inc.
16122937|NCT01988636|Drug|Placebo|Placebo
16122938|NCT01988623|Behavioral|Pivotal Response Treatment (PRT)|
16122939|NCT01988610|Drug|28 days treatment with Mifepristone.|
16122940|NCT01988597|Other|Dry eyes|
16122941|NCT01988584|Biological|Umbilical Cord Blood Stem Cells|Autologous umbilical cord blood banked with the Cord Blood Registry.
16122942|NCT01988584|Other|Saline Infusion (Placebo)|A total of 10 children (5 from each cohort) will be randomized to a placebo infusion at the baseline visit and then have the opportunity to cross-over to stem cell treatment at the 1yr. visit.
16122943|NCT01988584|Biological|Bone Marrow Stem Cells|Autologous stem cells from bone marrow harvest.
16122944|NCT01988571|Drug|Atorvastatin|40 mg tablet taken by mouth each morning for 24 months.
16122945|NCT01988571|Drug|Placebo|One placebo tablet taken each morning orally for 24 months.
16122946|NCT01988558|Drug|DL - Lactic Acid|Treated group to receive DL - Lactic Acid Syrup (Raspberry flavored)
16122947|NCT01988558|Dietary Supplement|Raspberry flavored syrup|Placebo group to receive Raspberry flavored Syrup
16122948|NCT01988545|Other|1,5 nmol/kg,GLP-1 sc injection|
16122949|NCT01988545|Other|1,5 nmol/kg GLP-1 9-36amide, sc injection|
16122950|NCT01988545|Other|Exendin-4 ;10 ug,sc injection|
16122951|NCT01988545|Other|saline|
16122952|NCT01988532|Other|No treatment given|Subject will only fill out a questionnaire
16122953|NCT01988519|Procedure|Closed gravity drain|passive tube drains (PFM Medical, Köln, Germany)
16122954|NCT01988519|Procedure|closed suction drain|BLAKE Silicon drains (Ethicon, USA)
16122955|NCT01988506|Drug|Interleukin 2|Induction period: repeated administration of low-dose IL-2 (1MUI/day, sc) during 5 consecutive days.Maintenance period: treatment with IL-2, 1MUI once every 15 days (except systemic lupus erythematosus's patients every 7 days) for 6 months
16122956|NCT01988493|Drug|Tepotinib 300 mg|Participants received Tepotinib 300 milligram (mg) orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
16122957|NCT01988493|Drug|Tepotinib 500 mg|Participants received Tepotinib 500 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
16122958|NCT01988493|Drug|Tepotinib 1000 mg|Participants received Tepotinib 1000 mg orally once daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal
16122959|NCT01988493|Drug|Tepotinib|Participants randomized to receive Tepotinib recommended Phase 2 dose (RP2D) determined from Phase 1b over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
16122960|NCT01988493|Drug|Sorafenib|Participants randomized to receive Sorafenib 400 mg orally twice daily over a 21-day cycle until disease progression, intolerable toxicity or participant withdrawal.
16122961|NCT01988480|Procedure|Image-guided surgery|Placement on residual bone around the implant
16122962|NCT01988480|Procedure|Sinus lift surgery|Allograft bone
16122963|NCT01988467|Other|exposure to second hand smoking|The duration of the exposure to second hand smoke both days was for 20 minutes within a 250mgr/m3 concentration box room. A smoking machine was used, which mimics the smoker (up to 6 breaths per minute in tobacco volume 80ml for each inhalation). The exposure was sometimes with closed mouth and others with closed nose in random sequence.
16122964|NCT01988428|Drug|Ceftriaxone 2000 mg|Ceftriaxone 2000 mg
16122965|NCT01988415|Device|VSS-Rx1 OPM vs Commercial iDesign Treatment|Commercially available iDesign treatment planning software used to calculate the LASIK treatment profile vs VSS-Rx1 OPM (includes a modified algorithm designed to reduce the induction of postoperative spherical aberration).
16122966|NCT01988402|Drug|allopurinol|
16122967|NCT01988402|Drug|Placebo (sugar pill)|
16122968|NCT01988389|Dietary Supplement|whole apples (WA)|
16122969|NCT01988389|Dietary Supplement|apple juice (AJ)|
16122970|NCT01988376|Device|Surepath|A liquid-base method of Pap smear for screening the recurrence of cervical cancer
16122971|NCT01988376|Device|Conventional Pap smear|Conventional Pap smear
16122972|NCT01988363|Procedure|GON injection at C2 location|GON will be identified at the novel, proximal C2 location on the symptomatic side via ultrasound guidance. Prior to injection, an independent examiner will perform a sensory exam of the involved dermatome. A 25 gauge spinal needle will be inserted into the symptomatic side after locating the GON via ultrasound at the C2 level. Subjects will be injected with treatment medication. Thirty minutes after injection, an independent examiner will test for anesthesia over the desired dermatome. VAS will be assessed pre-injection, 30 post-injection, 2 weeks post-injection and 1 month post-injection. The 2 week and 1 month assessments will be conducted by telephone.
16123092|NCT01987479|Drug|Tocilizumab|Tocilizumab 162 mg will be administered once a week by SC injection and as a single fixed dose, irrespective of body weight, for the treatment duration of 24 weeks.
16122973|NCT01988337|Device|Resin infiltration|The study is a split-mouth design. One tooth with a proximal caries lesion will randomly receive the infiltrating resin (Icon) while the other will receive a placebo, according to the manufactores´ instruction for Icon. In short, teeth will be isolated with a rubber dam and the tooth surface cleaned with non-fluoride prophylactic paste and pumice. The Icon material will be applied following the manufacturer's instructions and light cured, followed by polished using interproximal finishing/polishing strips (Sof Lex, 3M ESPE, St Paul, MN). Subjects will be given a letter to take to their local dentist asking them not to treat the selected lesions without informing the investigator first.
16122974|NCT01988337|Other|Mock treatment|"For the mock treatment the procedure will be identical to the Resin Infiltration intervention, with the exception that a placebo will be used. Essentialy, syringes identical to the Icon materials will be supplied by DMG for the placebo procedure. The syringes will be filled with solutions having the same consistency and color as the Icon material."
16122975|NCT01988324|Other|FDHT-PET scan|
16122976|NCT01988324|Other|FES-PET scan|
16122977|NCT01988324|Other|CT-scan|
16122978|NCT01988324|Other|Bone scintigraphy|
16122979|NCT01988324|Other|Tumor biopsy|
16122980|NCT01988311|Drug|psilocybin|dose manipulation as described in the protocol
16122981|NCT01988298|Drug|Ibuprofen|Ibuprofen 400 mg each 8 hours
16122982|NCT01988298|Drug|Acetaminophen|Control group
16122983|NCT01988285|Other|Specimen Collection|Blood collection, possible saliva collection, possible urine collection, and biopsy collection
16122984|NCT01988285|Other|Questionnaires|Subjects will complete a questionnaire utilizing validated symptom-specific instruments (Mayo Dysphagia Scale; GERD-HRQL Scale). The questionnaire will also record patient demographics, medical history, and current and past medication use
16122985|NCT01988272|Device|SPECT/CT imaging|Patients will undergo scanning on the above system.
16122986|NCT01988259|Procedure|Bilateral approach for Laminoplasty|Open bilateral approach for laminoplasty in multilevel cervical spinal stenosis
16122987|NCT01988259|Procedure|Unilateral approach for laminoplasty|Unilateral minimally invasive approach for laminoplasty in multilevel cervical spinal stenosis.
16122988|NCT01988259|Procedure|Subperiosteal approach for foraminotomy|Unilateral subperiostal approach for single level foraminotomy
16122989|NCT01988259|Procedure|Transmuscular approach for foraminotomy|Unilateral transmuscular approach for single level foraminotomy
16122990|NCT01988246|Drug|Aflibercept|Patients will be assigned to treatment with 2 mg intravitreal Aflibercept injection (0.05 mL or 50 microliters) administered at the time of surgery (post cataract excision) or sham injection.
16122991|NCT01988246|Drug|Sham|Sham injection. No actual injection. No medication is used.
16122992|NCT01988233|Behavioral|BAILAMOS© Dance Program|
16122993|NCT01988233|Behavioral|Health Education Control Group|
16122994|NCT01988220|Other|sensory retraining|
16122995|NCT01988220|Other|repeated sensory input|sensory stimulation without attentive learning focus
16122996|NCT01988207|Behavioral|Vocal Hygiene Training|Patients will receive education on how to care for their voices on three factors: 1) hydration, 2) exogenous inflammation control, and 3) abstinence of yelling and screaming.
16122997|NCT01988207|Behavioral|Flow Phonation Exercises|Three exercises are employed: gargling, cup bubble blowing, and stretch and flow (tissue blowing). Each is done without voicing, with voicing, and then with variations in pitch and verbalization.
16122998|NCT01988194|Procedure|Acupuncture|Acupuncture treatments will be provided in patient rooms up to four days per week for the duration of their hospital stay. Treatments will be consistent with how acupuncture is typically practiced: acupuncturists will diagnosis patients according to principles of traditional Chinese medicine (TCM); and treatments will be individualized to the patients. Duration of assessment, needle placement and retention will be 20-30 minutes.
16122999|NCT01988181|Device|BVM-UF biofeedback|The Fresenius 5008 uses an ultrasound and temperature monitor incorporated into the machine to detect ultrasonic velocity and temperature changes to derive the total protein concentration, which is a sum of total plasma proteins and hemoglobin. The relative blood volume is calculated at by dividing the initial concentration of total protein by the total protein concentration at any given time, multiplied by 100. The HD software is based on the critical blood volume entered at the beginning of the dialysis session for each individual patient. The UF rate is adjusted based on the changes in the relative blood volume to the patient's critical relative blood volume.
16123000|NCT01988181|Device|Fresenius 5008 HD machine (Fresenius Medical Care, Bad Homburg, Germany)|For an 8-week period, patients in the best clinical practice (control) phase will use their same prescription as the run-in phase, dialysate sodium of 138mmol/L, dialysate calcium of 1.25mmol/L, dialysate temperature of 36oC, and constant UF rate. BVM will be disabled in this group.
16123001|NCT01988168|Procedure|Suture closure|A running subcuticular suture is placed by taking horizontal bites through the papillary dermis on alternating sides of the wound. An absorbable suture is used and left in place until degraded and absorbed by the patient's tissues.
16123002|NCT01988168|Procedure|Staples closure|Surgical stapling devices re-appose skin edges with stainless steel or titanium staples. A second operator everts the wound skin edges while the operator applies staples along the incision. Staples can be removed on post-operative day 2 or 3, or delayed further according the surgeon preference based on patient characteristics.
16123003|NCT01988155|Other|Eccentric Exercise|Subjects in the eccentric exercise group will be instructed to perform the modified Alfredson eccentric protocol for insertional Achilles tendinopathy. To perform the eccentric exercise, subjects will be instructed to stand upright with one hand on the wall or a chair for support as needed. A heel raise exercise is then performed with the non-painful leg. Once in the elevated position, subjects are instructed to transfer all of their body weight to the painful leg and slowly lower their heel to the floor while keeping their knee extended. The eccentric exercise program will consist of 3 sets of 15 repetitions performed per session. Subjects will perform 2 sessions per day for a total of 12 weeks and a log will be kept to monitor compliance. In order to partially control for the effect of regular contact with a therapist, subjects in the control group will be contacted by telephone one time per week to discuss their progress with the program and address any questions they may have.
16123093|NCT01987479|Drug|Methotrexate|Methotrexate will be administered per investigator's discretion.
16123164|NCT01986920|Drug|A-101 Vehicle|Placebo applied to one of 4 Target Lesions
16123004|NCT01988155|Other|Astym|In addition to performing the same eccentric protocol as the eccentric exercise group, subjects in the Astym group will also be seen in the clinic two times per week. Astym treatment will be performed per the foot, ankle, and knee protocol as described in the Astym clinical manual. During the first visit each week, the eccentric exercise protocol will be orally reviewed to match the one time per week phone education received by the eccentric only group. Astym treatment will continue for up to six weeks but may be discontinued early if a subject scores 90 or above on the VISA-A. Subjects in the Astym group will be required to continue with the eccentric exercise protocol for the full 12 weeks even in Astym is discontinued early.
16123005|NCT01988142|Procedure|Ankle continuous passive motion machine.|A rehabilitation program of machine driven passive stretch.
16123006|NCT01988129|Other|Sleep disorders education and screening|Firefighters were instructed to attend an education presentation as operations allowed which provided information on firefighter mortality, fatigue-related health hazards and discussed the importance of sleep, and also included strategies to improve sleep hygiene and how to use caffeine and naps effectively to promote alertness. Firefighters were then invited to complete a voluntary sleep disorders screening survey. This survey used validated, self-report screening tools for obstructive sleep apnea, moderate to severe insomnia, restless legs syndrome and shift work disorder. All of those who screened positive for a high risk of any sleep disorder were notified by letter as to their risk and provided with contact information for a partnering sleep clinic if they chose to follow-up.
16123007|NCT01988116|Drug|Oral Calcitriol 0.5 mcg once daily for 6 weeks|
16123008|NCT01988116|Drug|Placebo|
16123009|NCT01988103|Drug|Apremilast|20 mg tablet BID for 68 weeks
16123010|NCT01988103|Drug|Apremilast|20 mg tablet BID for 68 weeks
16123011|NCT01988103|Drug|Placebo|Placebo tablet BID for 16 weeks
16123012|NCT01988090|Drug|800 IU Vitamin D Supplement|Standard Dose
16123013|NCT01988090|Drug|50,000 IU Vitamin D supplement|High Dose
16123014|NCT01988077|Biological|Adoptive cell transfer|Adoptive cell transfer
16123015|NCT01988077|Drug|Ipilimumab 5 MG/ML Injection [Yervoy]|2 treatments of Ipilimumab before transfer of TIL and 2 treatments of Ipilimumab after TIL
16123016|NCT01988064|Other|Face-to-face training|One-to-one face-to-face training on calculating the pulse rate and detecting abnormalities.
16123017|NCT01988064|Other|Group training|Group training using a tutorial film on calculating the pulse rate and detecting abnormalities.
16123018|NCT01988012|Biological|tocilizumab|162 milligram (mg) administered subcutaneously once weekly for 24 weeks
16123019|NCT01987999|Dietary Supplement|Acetogenins|
16123020|NCT01987986|Biological|Collagenase Clostridium Histolyticum|injectible intervention
16123021|NCT01987986|Biological|Placebo|
16123022|NCT01987973|Procedure|Partial Rotator Cuff Repair|This is the control group. The bursa will be debrided thoroughly and rotator cuff edges will be shaved down to stable tissue. If possible, rip-stop sutures will be employed to stabilize the tear. The subacromial space will then be thoroughly irrigated.
16123023|NCT01987973|Procedure|Partial Rotator Cuff Repair with Allograft Augmentation|Patients in this arm will undergo a partial rotator cuff repair (debridement), followed by an allograft augmentation. An Allopatch HD patch will be rehydrated in saline solution for 15 minutes. The patch is then sewn in place with braided polyester suture material. Multiple sutures, approximately 5 to 10 mm apart from one another will be used. The medial sutures are placed at least 3 cm medial to the tendon-bone attachment site. The patch is stretched to remove the manufacturing surface irregularities. The patch is then attached to the greater tuberosity at the tendon-bone attachment site with arthroscopic bone anchors. The subacromial space will then be thoroughly irrigated.
16123024|NCT01987960|Drug|Placebo|Once daily, tablets, orally
16123025|NCT01987960|Drug|Brexpiprazole|1 to 3 mg/day, once daily dose, tablets, orally
16123026|NCT01987947|Drug|Placebo|Two administrations by subcutaneous injection
16123027|NCT01987947|Drug|Quilizumab|Two administrations by subcutaneous injection
16123028|NCT01987908|Drug|Aes-103|The active ingredient in Aes-103 is 5-hydroxymethyl furfural (5-HMF). Aes-103 and matching placebo are administered in a liquid oral formulation.
16123029|NCT01987908|Other|Placebo|
16123030|NCT01987895|Drug|Cadazolid|Cadazolid 250 mg as oral suspension twice daily.
16123031|NCT01987895|Drug|Vancomycin|Vancomycin 125 mg as oral capsules 4 times daily.
16123032|NCT01987895|Drug|Cadazolid-matching placebo|Placebo matching cadazolid and administered orally twice daily
16123033|NCT01987895|Drug|Vancomycin-matching placebo|Placebo capsules matching vancomycin and administered orally 4 times per day
16123034|NCT01987856|Procedure|Blastocyst morphology|microscopic examination only
16123035|NCT01987843|Drug|MT-1303-Low|
16123036|NCT01987843|Drug|MT-1303-Middle|
16123037|NCT01987843|Drug|MT-1303-High|
16123038|NCT01987843|Drug|Placebo|
16123039|NCT01987830|Device|MRI-PET|"[11C] temozolomide for PET scan and a contrast dye for the MRI scan
~Drawing blood to assess the radioactivity of [11C] temozolomide"
16123040|NCT01987830|Device|TMZ-PET|The PET scan will take approximately 90 minutes. You will receive one injection of [11C] temozolomide. Following the injection of the radioactive substance, blood samples will be taken from the second IV line.
16123041|NCT01987817|Biological|AR101 powder provided in capsules|Study product formulated to contain peanut protein at different dosage strengths for use as defined in the protocol
16123042|NCT01987817|Biological|Placebo powder provided in capsules|Study product formulated to contain only inactive ingredients for use as defined in the protocol
16123043|NCT01987804|Drug|Oxytocin 100 i.u.|
16123044|NCT01987804|Drug|Oxytocin 400 i.u.|
16123045|NCT01987804|Drug|Placebo|
16123046|NCT01987778|Other|Resistance training|Resistance training supervised and individualized by an experienced physiotherapist. First the relative load will be lighter during three weeks, thereafter the intensity and load will be increased over another 12 weeks.
16123047|NCT01987765|Drug|Relestat Ophthalmic Solution 0.05%|Relestat Ophthalmic Solution 0.05% prescribed as local standard of care in clinical practice.
16123048|NCT01987752|Drug|brimonidine tartrate/timolol maleate Ophthalmic Solution|brimonidine tartrate/timolol maleate (Combigan®) Ophthalmic Solution as per local standard of care in clinical practice.
16123049|NCT01987739|Drug|200 mg almorexant|
16123050|NCT01987739|Drug|400 mg almorexant|
16123057|NCT01987713|Behavioral|lifestyle intervention|the intervention strength (amount, frequency, duration) including a reduction in energy intake and an increase in physical activity level will be reported. The guidance/description of the treatment protocol, preparation and training of intervener, techniques to retain the research subjects will be covered to prevent the lack of intervention integrity. Besides, the schooler admitted in a university hospital will be invited to explore their health lifestyles and receive the intervention.
16123058|NCT01987700|Device|FLEX-HD|
16123059|NCT01987700|Device|Strattice|
16123060|NCT01987687|Behavioral|Exercise|Exercise at 55% of maximum power output for 30 min.
16123061|NCT01987687|Behavioral|Rest|Rest for 30 min
16123062|NCT01987687|Behavioral|Delay|Delay between exercise and OGTT
16123063|NCT01987674|Dietary Supplement|Pre-meal protein drink|
16123064|NCT01987674|Other|Water drink|
16123065|NCT01987661|Device|BIPAP ST|non invasive ventilation, individually titrated for each patient, if necessary combined with oxygen, to improve hypercapnic respiratory failure.
16123066|NCT01987661|Device|Airtrap|"Addional to the individally titrated BiPAP ventilation parameters the function AirTrap Control is added.
~AirTrap Control helps to prevent dynamic hyperinflation and makes it possible for VENTImotion 2 to automatically regulate to the best frequency and expiration time."
16123067|NCT01987648|Procedure|Elective Craniotomy Patients|Patients who receive an elective craniotomy (no biopsy, no awake surgery, no re-operation)
16123068|NCT01987635|Device|MEMO 3D ring|The experimental MEMO 3D ring is placed.
16123069|NCT01987635|Device|Standard use of rigid ring.|The rigid ring is placed, which is standard procedure.
16123070|NCT01987635|Procedure|3D Echocardiography|
16123071|NCT01987622|Procedure|Acupuncture|The patients in this group will receive individualized acupuncture prescribed by a certified Korean Medicine Doctor (KMD) with at least three years of clinical experience. The acupuncture formulas will be determined based on the individual patient's symptoms and at the KMD's discretion. The acupuncture treatment will be applied one to three times a week for six weeks (a total of 12 sessions and an additional four sessions are allowed). Acupuncture will be manually stimulated at first, and then electrical stimulation will be allowed at the KMD's discretion. Retention time will be equal to or less than 20 minutes. Examples of acupuncture points to be used might include LI4, LI11, TE5, SI3, TE3, ST36, SP6, SP9, LR3, GB34, Gb39, BL40, BL57, EX-B2, and BL23.
16123072|NCT01987622|Procedure|Usual care|Usual care consists of patient education for a healthier lifestyle, including diet, exercise, self-management of symptoms, and the use of other treatments as needed. Participants will receive a three-page leaflet of patient education material. Optional regular physical therapies, including interferential current therapy (ICT) and local heat application, will be provided only for the control group at the participants' request . Physical therapy will be provided one to three times a week for six weeks (a total of 12 sessions and an additional four sessions are allowed). All kinds of conservative interventions for lumbar spinal stenosis, including analgesics and non-study physical treatments,will be allowed. However, surgical treatments, non-study acupuncture, or herbal medicine will not be allowed.
16123073|NCT01987609|Drug|Hylenex|
16123074|NCT01987609|Drug|Normal Saline|
16123075|NCT01987596|Biological|filgrastim|Given SC once daily starting on day 1 after chemotherapy in Arm I (fixed) and on any day when ANC drops below 1000/mcl in Arm II (flexible)
16123076|NCT01987583|Procedure|Wet cupping|Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin.
16123077|NCT01987583|Other|Conventional treatment|According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital.
16123078|NCT01987570|Drug|Allopurinol|
16123079|NCT01987570|Drug|Placebo|
16123080|NCT01987557|Behavioral|rate group|walking with a high cadence (steps per minute)
16123081|NCT01987557|Behavioral|magnitude treadmill group|
16123082|NCT01987557|Behavioral|regular treadmill walking|
16123083|NCT01987544|Other|Ergometer Training|
16123084|NCT01987544|Other|Motivation|
16123085|NCT01987531|Other|left ventricular epicardial pacing lead|
16123086|NCT01987518|Other|Procedure surgery behavioral and genetic diagnosis|Observational Study
16123087|NCT01987518|Procedure|quality of life after different type of surgery|
16123088|NCT01987505|Drug|Rituximab|1400 mg will be injected subcutaneously (SC).
16123089|NCT01987492|Drug|Lebrikizumab|Lebrikizumab will be administered as SC injections every 4 weeks at dose and schedule described in arm description.
16123090|NCT01987492|Drug|Placebo|Placebo matching to lebrikizumab will be administered as SC injections every 4 weeks as per schedule described in arm description.
16123091|NCT01987479|Drug|Non-Biologic DMARDs|Treatment with non-biologic DMARDs, at a stable dose that was initiated at least 4 weeks prior to baseline, is permitted during the study and is at the investigator's discretion.
16123162|NCT01986920|Drug|A-101 32.5%|Mid Dose Concentration of A-101 applied to one of 4 Target Lesions
16123094|NCT01987466|Biological|Serum NGAL level|Investigators will check the plasma NGAL level after 4 hour from resuscitation. The plasma NGAL level is measured in ng/mg
16123095|NCT01987453|Drug|LDV/SOF|Tablet(s) administered orally once daily
16123096|NCT01987453|Drug|RBV|"Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
~Participants in the LDV/SOF+RBV 24 weeks group will dose adjust RBV according to hemoglobin and renal status as stated in the RBV package insert."
16123097|NCT01987440|Drug|lubricating gel|
16123098|NCT01987427|Drug|lorcaserin + phentermine placebo|lorcaserin 10 mg BID + phentermine placebo BID
16123099|NCT01987427|Drug|lorcaserin + phentermine-HCl + phentermine placebo|lorcaserin 10 mg BID + phentermine-HCl 15 mg QD + phentermine placebo QD
16123100|NCT01987427|Drug|lorcaserin + phentermine-HCl|lorcaserin 10 mg BID + phentermine-HCl 15 mg BID
16123101|NCT01987414|Behavioral|occupational therapy task-oriented approach|It is a standard treatment in occupational therapy for persons post-stroke or other neurological conditions. It is an approach that emphasizes client-centered, goal-directed, and functional training for restoration of life roles.
16123102|NCT01987414|Device|Forearm rotation orthosis|The forearm rotation orthosis is made of Latex-free material and is a custom-molded orthosis designed to assist forearm rotation without limiting functional elbow flexion and extension.
16123103|NCT01987414|Other|No treatment|Participants will maintain their daily routines during the no treatment period.
16123104|NCT01987388|Other|High Intensity Exercise|While in the calorimeter, each subject will complete four bouts of exercise. Each bout is approximately 5 minutes in duration at a predetermined speed and elevation to achieve an intensity of 85% of VO2 max according to their fitness level test described previously. Subjects then sit quietly until either the next meal or the next exercise bout.
16123105|NCT01987388|Other|Low Intensity Exercise|While in the calorimeter, each subject completes one exercise bout approximately 40 minutes in duration, at a predetermined speed and elevation, to achieve an intensity of 65% of VO2 max. Subjects then sit quietly until the next meal.
16123106|NCT01987388|Other|High Carbohydrate Beverage|Participants will consume a high carbohydrate beverage (750 g) with the following composition: 2.13 MJ/d, 113g carbohydrate, 4g fat, 6g protein.
16123107|NCT01987388|Other|High Fat Beverage|Participants will consume a high fat beverage (750 g) with the following composition: 2.11 MJ/d, 8g carbohydrate, 50g fat, 7g protein.
16123108|NCT01987375|Drug|Cetuximab-IRDye800|a single dose of the study drug following a single loading dose of unlabeled cetuximab
16123109|NCT01987362|Drug|RO6870810|Participants will receive RO6870810 at different planned doses with a starting dose of 0.03 mg/kg to a maximum dose of 0.85 mg/kg SC on Days 1 to 14 in a 21-day treatment cycle or on Days 1 to 21 in a 28-day treatment cycle.
16123110|NCT01987349|Biological|Fluzone® (intramuscular)|Licensed seasonal trivalent inactivated influenza vaccine (IIV3)
16123111|NCT01987349|Biological|FluMist® (intranasal)|Licensed trivalent seasonal live attenuated influenza vaccine (LAIV3)
16123112|NCT01987323|Drug|Subconjunctival injection of liposomal latanoprost|
16123113|NCT01987310|Drug|atorvastatin|atorvastatin 20 mg per day for 6 months
16123114|NCT01987310|Behavioral|lifestyle counseling|lifestyle modification by dietician counseling and follow up
16123115|NCT01987297|Drug|ATRA+Arsenic|"ATRA: 25mg/m2 daily；Induction: D1 to CR; Consolidation: D1-14 each course; Maintenance: D1-14 each course.
~Arsenic: 0.16mg/kg daily. Induction: D1 to CR; Consolidation: low/intermediate-risk patients 28 days each course; high-risk: 14 days each course; Maintenance: 14 days on and off each course.
~Idarubicin 8mg/m2 or Daunorubicin 45mg/m2 daily. Induction: 3-4 days in high-risk patients or intermediated-risk patients with leukocytosis developed during induction therapy. Consolidation: 3 days in high-risk patients in first 2 courses.
~MTX: 15mg/m2 qw Maintenance: qw x 4 in each course for high-risk patients."
16123116|NCT01987297|Drug|ATRA+Chemo|"ATRA: 25mg/m2 daily；Induction: D1 to CR; Consolidation: D1-14 each course; Maintenance: D1-14 each course.
~Arsenic: 0.16mg/kg daily. Induction: D1 to CR; Maintenance: 14 days on and off each course.
~Idarubicin 8mg/m2 or Daunorubicin 45mg/m2 daily. Induction: 3-4 days in high-risk patients or intermediated-risk patients with leukocytosis developed during induction therapy. Consolidation: 3 days in all patients in 2 courses.
~Cytarabine: 150mg/m2 or 1g/m2. Consolidation: 150mg/m2 daily x 7 days in high risk patients in first 2 courses; 1g/m2 q12 x 6 doses in third course.
~MTX: 15mg/m2 qw Maintenance: qw x4 in each course for high-risk patients."
16123117|NCT01987284|Drug|SER100|
16123118|NCT01987284|Drug|Placebo|
16123119|NCT01987271|Device|Noninvasive Ventilation|A randomized plan define the order in which patients would execute the 6MWT, with or without NIV.
16123120|NCT01987258|Behavioral|Interval Walking|
16123121|NCT01987258|Behavioral|Continuous walking|
16123122|NCT01987232|Drug|Carfilzomib|Administered by intravenous infusion.
16123123|NCT01987232|Drug|Carboplatin|Administered by intravenous infusion.
16123124|NCT01987232|Drug|Etoposide|Administered by intravenous infusion.
16123125|NCT01987219|Drug|Albuterol-sulphate|Beta-2-adrenergic agonist 2.5 mg 3 cc inhalation Peak effect 15 - 30 mins. Mean duration of effect 3 hours
16123126|NCT01987219|Drug|Ipratropium-bromide|Anti-cholinergic 500 mcg 3 cc inhalation Peak effect 30 - 90 mins. Duration of effect 2 - 4 hours.
16123127|NCT01987219|Other|placebo|Saline solution 3 cc NA
16123128|NCT01987206|Device|MPC control algorithm|
16123129|NCT01987206|Device|PID control algorithm|
16123130|NCT01987167|Drug|ACTHAR|Injectable Gel
16123131|NCT01987154|Other|Marketed cow milk-based premature infant formula|
16123132|NCT01987154|Other|Marketed extensively hydrolyzed casein infant formula|
16123133|NCT01987141|Other|EMR Intervention|Electronic medical record flag/notification in the patient's chart
16123134|NCT01987128|Procedure|Intraneural injection|BBraun Ropivacaine 1% 12ml injection divided in each sciatic components under echographic guidance with a PAJUNK SonoPlex 22G needle.
16123135|NCT01987128|Procedure|Extraneural injection|BBraun Ropivacaine 1% 12ml extraneural injection around sciatic nerve under echographic guidance with a PAJUNK SonoPlex 22G needle.
16123136|NCT01987128|Drug|Ropivacaine|
16123137|NCT01987128|Device|PAJUNK SonoPlex 22G needle.|
16123163|NCT01986920|Drug|A-101 40%|High Dose Concentration A-101 applied to one of 4 Target Lesions
16123138|NCT01987115|Procedure|Fascial manipulation|Group will receive fascial manipulation at 3 centers of coordination (C.C) at: 1. C.C above the pronator teres muscle. (M.F unit of INTRA-CUBITUS), 2. C.C above proximal part of pronator quadratus muscle, between the palmaris longus and the flexor carpi radialis tendons (M.F unit of INTRA-CARPUS), 3. C.C in the mid-palmar region between metacarpus 3-4 (M.F unit of INTRA-DIGIT).4. C.C. over the muscle belly of Ext. Digit and Ext. Pollicis Longus (M.F unit of EXTRA-CARPUS).
16123139|NCT01987115|Procedure|Traditional physiotherapy|Group will receive U.S. treatment delivered to the A1 pulley area (3 Megahertz, over 1cm², for 5 minutes), Metacarpophalangeal and Proximal interphalangeal joint mobilization (for 5 minutes), eccentric stretching, and self exercises at home (self-stretch and self-massage).
16123140|NCT01987102|Drug|Calcium Folinate|"The enrolled patients will be treated according to the MAP schedule and will receive the study drug Calcium Folinate commencing 24 hours after the administration of HDMTX and then every 6 hours (q6h) thereafter until the S-MTX levels are ≤ 0.1 µmol/L, in accordance with COG management recommendations.
~All patients will receive standard o care (SOC) in the two (2) first HDMTX courses and [6R] 5,10-methylenetetrahydrofolate in the two (2) following courses. Patients will be enrolled in two (2) [6R] 5,10-methylenetetrahydrofolate dose cohort groups: with [6R] 5,10-methylenetetrahydrofolate start dose of 15 mg/m2 (i.e. the same as for SOC rescue) the first cohort will be administered, and 7.5 or 30 mg/m2 in the second cohort."
16123141|NCT01987102|Drug|[6R] 5,10-methylenetetrahydrofolate (arfolitixorin)|"The enrolled patients will be treated according to the MAP schedule and will receive the study drug [6R] 5,10-methylenetetrahydrofolate commencing 24 hours after the administration of HDMTX and then every 6 hours (q6h) thereafter until the S-MTX levels are ≤ 0.1 µmol/L, in accordance with COG management recommendations.
~All patients will receive standard o care (SOC) in the two (2) first HDMTX courses and [6R] 5,10-methylenetetrahydrofolate in the two (2) following courses. Patients will be enrolled in two (2) [6R] 5,10-methylenetetrahydrofolate® dose cohort groups: with [6R] 5,10-methylenetetrahydrofolate start dose of 15 mg/m2 (i.e. the same as for SOC rescue) the first cohort will be administered, and 7.5 or 30 mg/m2 in the second cohort."
16123142|NCT01987089|Behavioral|Cognitive Behavioral Therapy for Insomnia (CBT-I)|Eight Session CBT-I: Cognitive Behavioral therapy is conducted in 8 individual sessions with the study clinician.
16123143|NCT01987076|Drug|Prednisone|"Prednisone:
~Day 0 to day 30: 0.5mg/kg/day Day 30 to day 180: doses decreasing from 15 to 25% every 15 days until Day75 and 10 to 15% every 15 days."
16123144|NCT01987076|Drug|Clobetasol|Clobetasol: cream 0.05% Day 0 to day 30: 30 grams per day Day 30 to day 45: 20 grams per day Day 45 to day 60: 20 grams every other day Day 60 to day 120: 20 grams biweekly Day 120 to day 150: 20 grams one a week
16123145|NCT01987037|Behavioral|neuropsychomotor assessment|Children with autism spectrum disorders pass a specific battery test (NP-MOT) for a neuropsychomotor assessment. This neuropsychomotor assessment is administered in a half-day maximum. This battery aims to investigate passive muscle tone (shoulders, limbs, and trunk), standing and synkinesia, static and dynamic balance, tonic laterality (extensibility and dangling of hands and feet to identify the tonic dominant side), laterality of use, fine-digit movements, digital tactile gnosis, and body spatial integration (knowing left from right: for oneself and that of others, and with regard to objects).
16123146|NCT01987024|Device|Actim Partus® test|
16123147|NCT01987024|Other|usual procedure|
16123148|NCT01987011|Biological|MG1109|
16123149|NCT01987011|Biological|Placebo|
16123150|NCT01986998|Drug|Methylprednisolone 1250 mg/24h x3 days|Oral Methylprednisolone 1.250 mg daily, over 1 hour and during 3 consecutive days. 13 capsules will be administered (12 capsules of 100 mg and 1 capsule of 50 mg)
16123151|NCT01986998|Drug|Oral Methylprednisolone 625 mg/24h x3 days|Oral Methylprednisolone 625 mg daily, over 1 hour and during 3 consecutive days. 13 capsules will be administered (6 capsules of 100 mg, 1 capsule of 25 mg and 6 capsules of placebo with the same appearance of capsules of 100 mg)
16123152|NCT01986985|Device|PET/MRI system|Compared to PET CT
16123153|NCT01986972|Other|Toothbrushing With Dentifrice|The participants were instructed to interrupt any chemical and/or mechanical oral hygiene procedure for 72 hours. Dental plaque was stained by a 2% erithrosin solution, followed by a mouth rinsing with water for 1 minute. Next, the set of dental quadrants (1-3 and 2-4) were randomly allocated to experimental groups by the flip of a coin. One of the sets was brushed with multi bristle brush without the use of dentifrice and the second set was brushed with multi bristle brush using dentifrice. Toothbrushing was performed by the individual's regular technique timed. Two minutes was used for each set. After toothbrushing, the dental biofilm was again stained and evaluated by the same examiner, who was blind to the quadrants brushed with or without dentifrice.
16123154|NCT01986972|Other|Toothbrushing Without Dentifrice|The participants were instructed to interrupt any chemical and/or mechanical oral hygiene procedure for 72 hours. Then, dental plaque was stained by a 2% erithrosin solution, followed by a mouth rinsing with water for 1 minute. Next, the set of dental quadrants (1-3 and 2-4) were randomly allocated to experimental groups by the flip of a coin. One of the sets was brushed with multi bristle brush without the use of dentifrice and the second set was brushed with multi bristle brush using dentifrice. Toothbrushing was performed by the individual's regular technique timed. Two minutes was used for each set. After toothbrushing, the dental biofilm was again stained and evaluated by the same examiner, who was blind to the quadrants brushed with or without dentifrice.
16123155|NCT01986959|Procedure|With Periodontal dressing|After surgery,the dressing was mixed with a sterile spatula on a sterile glass plate following the manufacturer's instructions (2 cm of each paste measured with a sterile endodontic ruler). Coe-PakTM Regular was the dressing employed. Mixing and placement were performed only by the specialists in periodontics to ensure standardization. The dressing was inserted into the surgical wounds and molded to the necessary shape after setting sufficiently. The removal of the periodontal dressing was done after seven days.
16123156|NCT01986959|Procedure|Without Periodontal dressing|The dressing was not inserted.
16123157|NCT01986946|Other|Epidural Catheter - Dilaudid|Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
16123158|NCT01986946|Drug|Dilaudid|Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid).
16123159|NCT01986933|Drug|nemolizumab (CIM331)|
16123160|NCT01986933|Other|Placebo|
16123161|NCT01986920|Drug|A-101 25%|Low Dose Concentration of A-101 applied to one of 4 Target Lesions
16123165|NCT01986907|Drug|ranibizumab|All patients will receive ranibizumab 0.5 mg/0.05 ml according to approved label: treatment is given monthly until maximum VA is achieved (i.e. stable VA for three consecutive monthly assessments performed while on ranibizumab treatment). Thereafter according to approved label, patients should be monitored monthly for visual acuity and treatment is to be resumed when monitoring indicates loss of visual acuity due to disease activity. Monthly injections should then be administered until stable visual acuity is reached again for three consecutive monthly assessments (implying a minimum of two injections).
16123166|NCT01986894|Drug|Placebo|Single oral dose of Placebo
16123167|NCT01986894|Drug|Pomalidomide|Single oral dose of 4 mg pomalidomide
16123168|NCT01986894|Drug|Pomalidomide|Single oral dose of 20 mg pomalidomide
16123169|NCT01986894|Drug|Moxifloxacin|Single oral dose of 400 mg moxifloxacin tablet
16123170|NCT01986881|Drug|Ertugliflozin|Oral, once daily, for up to approximately 6 years
16123171|NCT01986881|Drug|Placebo|Matching placebo to ertugliflozin administered orally, once daily, for up to approximately 6 years
16123172|NCT01986881|Drug|Glycemic Rescue|Doses of background anti-hyperglycemic agents (AHA), medications will be required to be held constant in all participants enrolled for the initial 18 weeks of the trial with 2 exceptions: First, participant will be prescribed glycemic rescue therapy if they meet specific, progressively more stringent, glycemic thresholds based on repeated, confirmed fasting plasma glucose (FPG) measured at a central laboratory. Second, a participant experiencing clinically significant hypoglycemia according to the investigator at any time during the trial is permitted to have the dose of appropriate background AHA (e.g., insulin, sulfonylurea [SU], glinide) reduced or discontinued as per the judgment of the investigator or the treating physician. Choice and dosing of glycemic rescue will be at the discretion of the investigator or the treating physician consistent with standards of care for management of patients with Type 2 diabetes mellitus (T2DM) within the country of the investigational site.
16123173|NCT01986868|Other|Coronary MR Angiography (CMRA)|Stable patients who have undergone a clinically indicated CCTA study for suspected Coronary Artery Disease will undergo a research CMRA with contrast (Multihance or Optimark)total dose of up to 0.2 mmol/kg IV. Possible administration of oral beta-blocker (metoprolol)intravenous doses of 5mg IV metoprolol may be given every 2 minutes up to a maximal dose of 15 mg IV.
16123174|NCT01986855|Drug|Ertugliflozin 5 mg|Ertugliflozin, oral, 5 mg tablet once daily for 52 weeks
16123175|NCT01986855|Drug|Placebo 5 mg|Placebo to ertugliflozin, oral, tablet, 5 mg tablet once daily for 52 weeks
16123176|NCT01986855|Drug|Ertugliflozin 10 mg|Ertugliflozin, oral, tablet, 10 mg tablet once daily for 52 weeks
16123177|NCT01986855|Drug|Placebo 10 mg|Placebo to ertugliflozin, oral, tablet, 10 mg tablet once daily for 52 weeks
16123178|NCT01986842|Dietary Supplement|Protein diet|Subjects will receive either a low protein or a high protein diet for 14 days. High protein will be realized with protein supplements.
16123179|NCT01986829|Device|Microwave ablation|"Microwave ablation will be predominantly used on metastatic soft tissue lesions and will include use of Covidien's Evident™ MWA System. Microwave ablation is performed under ultrasound, CT, and occasional fluoroscopic guidance with CT fluoroscopy available for intermittent use in probe placement and CT monitoring of ablation.
~Microwave antennae from Covidien (Mansfield, MA) are either introduced into the lesion co-axially through a bone biopsy needle or directly into the lesions that are amenable to such, i.e., soft tissue, lung, liver, and large lytic lesions with extensive bone destruction."
16123180|NCT01986829|Device|Cryoablation|"Cryoablation is performed under ultrasound, CT and occasional fluoroscopic guidance with CT fluoroscopy available for intermittent use in cyroprobe placement and CT monitoring of ablation.
~Cryoprobes from Endocare Inc. (Irvine CA) or Galil Medical (Arden Hills MN) are either introduced into the lesion co-axially through a bone biopsy needle or directly into the lesions that are amenable to such, i.e., soft tissue, lung, liver, and large lytic lesions with extensive bone destruction."
16123181|NCT01986829|Device|Radiofrequency ablation|-Radiofrequency ablation will be predominantly used on metastatic spine lesions and will include use of the Dfine STAR ablation probe. This probe will be placed coaxially through an introducer needle into the spinal metastatic lesion.
16123182|NCT01986829|Other|BPI-Short form|-Prior to ablation, 1 day post-ablation, 1 month post-ablation (from first procedure if more than 1 is done), and time of disease progression
16123183|NCT01986829|Other|FACT-G7|-Prior to ablation, 1 day post-ablation, 1 month post-ablation (from first procedure if more than 1 is done), and time of disease progression
16123184|NCT01986803|Device|Percutaneous Coronary Intervention|"Implanting a device (Xience Xpedition stent or Abbott Vascular ABSORBTM everolimus eluting bioresorbable vascular scaffold system (BVS) to open a diseased coronary artery by going to the coronary artery subcutaneously through the arteries from the radial or femoral artery access point."
16123185|NCT01986790|Behavioral|Plain Language|
16123186|NCT01986790|Behavioral|Plain Language + Visuals|
16123187|NCT01986790|Behavioral|Plain Language + Narratives|
16123188|NCT01986777|Drug|lisdexamfetamine|
16123189|NCT01986777|Drug|Placebo|The placebo capsules will be filled with lactose.
16123190|NCT01986764|Drug|Lisdexamfetamine|
16123191|NCT01986764|Drug|Estradiol|
16123192|NCT01986764|Drug|Placebo|Placebo capsules will be filled with lactose powder.
16123193|NCT01986751|Drug|Clonidine|
16123194|NCT01986751|Drug|ropivacaine|
16123195|NCT01986738|Radiation|Standard Radiation Therapy|Radiotherapy will be planned and delivered according to institutional standard of care.
16123196|NCT01986738|Device|Active Breathing Control Device (ABC)|
16123197|NCT01986738|Device|Computed Tomography Scan (CT)|
16123198|NCT01986725|Behavioral|standardized care (Intervention I)|During treatment and routine follow-up consultations, patients randomized to standard care will be provided with usual care and a predefined set of additional written information leaflets about supportive care options in the early treatment phase designed for the study.Usual care includes treatment during hospitalization by the gynecologist and the nurses according to the existing guidelines. At each follow-up visit, the gynecologist will conduct a physical examination. The follow-ups include also treatment of adverse effects of the therapy and rehabilitation.
16123292|NCT01986036|Dietary Supplement|Calcium|Soluble calcium powder.
16123293|NCT01986036|Dietary Supplement|Porridge-based breakfast.|Oats and water.
16123294|NCT01986023|Behavioral|SMS- Short Messaging Service|
16123199|NCT01986725|Behavioral|Standardized care + WOMAN-PRO II program (Intervention II)|This intervention is in addition to standard care. Nurse-led follow-up consultations with the WOMAN-PRO II program complementary to physician appointments have the goal to support women's self-management abilities in order to deal with occurring symptoms and related distress. Content of the WOMAN-PRO II program designed for this study is summarized in a handbook for professionals including patient clinical pathways and nurse interventions, supplemented by a patient booklet (paper based and electronic version) with tailored information according to patients' needs. The program includes five consultations with an approximate total duration of two hours.
16123200|NCT01986699|Procedure|Laparoscopic Assisted Polypectomy|
16123201|NCT01986686|Procedure|Colon resection|Elective robotic/laparoscopic/open colon resection for diverticular disease.
16123202|NCT01986673|Drug|5% Sildenafil Cream (SST-6006)|5 % Sildenafil Cream
16123203|NCT01986673|Drug|Oral Sildenafil 50 mg|Oral Sildenafil 50 mg
16123204|NCT01986660|Drug|Ibuprofen Cream (SST-0225)|
16123205|NCT01986647|Behavioral|On the Move exercise - exercise leader|exercise physiologists
16123206|NCT01986647|Behavioral|Standard program - exercise leader|This is an impairment-based exercise program focusing on flexibility, strength and endurance and is taught by research staff who are PTs, PTAs, or exercise physiologists
16123207|NCT01986647|Behavioral|On the Move exercise - staff activity personnel|this is a group exercise program focusing on the timing and coordination of walking. The program is taught by a person from the facility that the research team trained.
16123208|NCT01986647|Behavioral|Standard program - staff activity personnel|This is an impairment-based exercise program focusing on flexibility, strength and endurance and is taught by a member of the facility that the research staff trained.
16123209|NCT01986634|Device|Laser Treatment|Patient will have split face laser resurfacing. One side of the face will be treated with a standardized single depth laser peel. The other side of the perioral area will be treated with variant, deeper treatment to perioral rhytids.
16123210|NCT01986608|Drug|Lacosamide infusion|"Strength: 10 mg/mL for infusion
~Form: solution for infusion
~Dosage: 200 mg, single dose
~Duration: 30-minute infusion or 60-minute infusion"
16123211|NCT01986608|Drug|Lacosamide oral|"Strength: 200 mg
~Form: film-coated tablet
~Dosage: 200 mg, single dose
~Duration: single oral intake"
16123212|NCT01986582|Drug|Oxymetazoline|Intranasal application
16123213|NCT01986582|Other|Hydroxyl-propyl-methyl cellulose powder|Intranasal application
16123214|NCT01986582|Other|Placebo (lactose powder)|Intranasal application
16123215|NCT01986569|Drug|[18F]fluoroestradiol (FES)|[18F]FES PET/CT will be performed 90 min (± 10 min) after administration of [18F]FES. Patients will undergo core needle biopsy or surgery within 15 days after [18F]FES PET; or patients will undergo core needle biopsy within 30 days before [18F]FES PET. Experienced pathologists will determine metastatic/recurrent disease, and tumor histology including IHC. Patient will undergo surgery, radiation therapy or systemic therapy according to the results of staging workup, histology and biomarkers.
16123216|NCT01986556|Drug|Lesinurad 400 mg (Site 1)|
16123217|NCT01986556|Drug|Lesinurad 400 mg (Site 2, Lot A)|
16123218|NCT01986556|Drug|Lesinurad 400 mg (Site 2, Lot B)|
16123219|NCT01986543|Drug|drug administration|
16123220|NCT01986530|Dietary Supplement|Boost|After an overnight fast, blood samples will be obtained before as well as 30 min after standardized mixed meal ingestion
16123221|NCT01986530|Other|Aerobic exercise|After an overnight fast and rest, blood samples will be obtained before as well as 30 min after aerobic exercise
16123222|NCT01986517|Behavioral|No feedback|Therapists will receive no feedback.
16123223|NCT01986517|Behavioral|Feedback after every fourth session|
16123224|NCT01986491|Drug|JNJ 39393406 30 mg solid X|Participants will receive JNJ 39393406 30 mg solid X formulation as a tablet orally (by mouth).
16123225|NCT01986491|Drug|JNJ 39393406 30 mg solid Y|Participants will receive JNJ 39393406 30 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
16123226|NCT01986491|Drug|JNJ 39393406 120 mg solid X|Participants will receive JNJ 39393406 120 mg solid X formulation as a tablet orally (by mouth).
16123227|NCT01986491|Drug|JNJ 39393406 120 mg solid Y|Participants will receive JNJ 39393406 120 mg solid Y formulation as a hard gelatin capsule orally (by mouth).
16123228|NCT01986491|Drug|JNJ 39393406 30 mg solution|Participants will receive JNJ 39393406 30 mg/mL solution orally (by mouth).
16123229|NCT01986465|Drug|Depomedrol|
16123230|NCT01986465|Drug|Placebo|
16123231|NCT01986452|Device|CPAP therapy|
16123232|NCT01986452|Other|Support|
16123233|NCT01986426|Drug|LTX-315 consecutive lesions|"Dose escalation:
~Cohort 1: 2 mg twice per day (4 mg) Cohort 2: 3 mg twice per day (6 mg) Cohort 3: 4 mg twice per day (8 mg)"
16123234|NCT01986426|Drug|LTX-315|"Dose escalation:
~Cohort 1: 3 mg per injection Cohort 2: 4 mg per injection Cohort 3: 5 mg per injection"
16123235|NCT01986426|Drug|LTX-315 + ipilimumab|Cohort 1: 3 mg per injection + 3 mg/kg ipilumumab Cohort 2: 4 mg per injection + 3 mg/kg ipilumumab Cohort 3: 5 mg per injection + 3 mg/kg ipilumumab
16123236|NCT01986426|Drug|LTX-315 + pembrolizumab|Cohort 1: 3 mg per injection + 200 mg pembrolizumab Cohort 2: 4 mg per injection + 200 mg pembrolizumab Cohort 3: 5 mg per injection + 200 mg pembrolizumab
16123237|NCT01986413|Device|pressure controlled ventilation BIPAP ST|spontaneous timed pressure controled bilevel ventilation
16123238|NCT01986413|Device|volume assured pressure support IVAPS|intelligent volume assured Pressure Support
16123239|NCT01986413|Device|NIV|Patients with COPD and chronic hypercapnic respiratory failure will spent two nights on NIV, one with spontaneous timed pressure controlled bilevel ventilation (BiPAP ST) and one with the advanced mode of intelligent volume assured pressure support (IVAPS). Patients will spend the treatment nights in randomized order under polysomnographic surveillance, including transcutaneous PCO2 measurement.
16123295|NCT01986010|Biological|V160 Low Dose IM|V160 administered as a 0.75 mL intramuscular injection
16123296|NCT01986010|Biological|V160 Medium Dose IM|V160 administered as a 0.75 mL intramuscular injection
16123297|NCT01986010|Biological|V160 High Dose IM|V160 administered as a 0.75 mL intramuscular injection
16123298|NCT01986010|Biological|V160 Medium Dose plus Merck Aluminum Phosphate Adjuvant (MAPA) 225 µg /dose IM|V160 plus MAPA administered as a 0.75 mL intramuscular injection
16123358|NCT01985607|Dietary Supplement|Extensively hydrolysed formula|
16123240|NCT01986400|Behavioral|Virtual Peer-to-Peer Support Mentoring|The mentorship program will encourage mentored participants to develop and engage in self-management and transition skills and support their practice of these skills. The mentors will present information to mentored participants in a monitored virtual interaction using Skype for 8 weeks (10 total Skype sessions of 30-60 minutes each) to encourage participation in skill building tailored to their needs. All mentors will complete a paid 2.5 day training course and will be supported throughout the duration of the study (consultations with research staff to deal with unforeseen concerns). Mentored participants will complete online outcome measures prior to randomization (T1) and upon study completion (T2).
16123241|NCT01986387|Behavioral|Virtual Peer-to-Peer Support Mentoring|The mentorship program will encourage mentored participants to develop and engage in self-management and transition skills and support their practice of these skills. The mentors will present information to mentored participants in a monitored virtual interaction using Skype for 8 weeks (10 total Skype sessions of 30-60 minutes each) to encourage participation in skill building tailored to their needs. All mentors will complete a paid 2.5 day training course and will be supported throughout the duration of the study (consultations with research staff to deal with unforeseen concerns). Mentored participants will complete online outcome measures prior to randomization (T1) and upon study completion (T2).
16123242|NCT01986374|Drug|HCG is introduced|must have good blastocysts
16123243|NCT01986361|Drug|flurbiprofen|A single flurbiprofen 8.75 mg lozenge which also contains 1 mg of menthol in its vehicle base for flavour and taste purposes (blinding). Lozenge is sucked until dissolved, and not chewed, bit or swallowed.
16123244|NCT01986361|Drug|placebo|A single placebo lozenge which also contains 1 mg of menthol in its vehicle base for flavour and taste purposes (blinding). Lozenge is sucked until dissolved, and not chewed, bit or swallowed.
16123245|NCT01986348|Drug|Selinexor|One cycle is 28 days (4 weeks).
16123246|NCT01986335|Biological|DTP/HB/Hib Vaccine|DPT/HB/Hib vaccine (Bio Farma)
16123247|NCT01986322|Biological|DTP/HB/Hib vaccine|Dosage equal to 0.5 mL administered intramuscularly
16123248|NCT01986322|Biological|DTP/HB and Hib vaccine|Dosage equal to 0.5 mL administered intramuscularly
16123249|NCT01986309|Drug|Lidocaine|Bolus 1.5 mg/kg over 5 minutes, then an infusion of 2 mg/kg/h
16123250|NCT01986309|Drug|Normal saline|Sodium Chloride 0.9% infusion
16123251|NCT01986296|Device|ExAblate Transcranial MRgFUS System|Treatment with the ExAblate Transcranial MRgFUS System.
16123252|NCT01986283|Drug|Capsule|Taken once
16123253|NCT01986283|Drug|PF-00345439|40 mg capsule swallowed whole, taken once
16123254|NCT01986283|Drug|PF-00345439|40 mg capsule chewed, taken once
16123255|NCT01986283|Drug|oxycodone|40 mg solution, taken once
16123256|NCT01986270|Drug|Placebo|Matching Placebo
16123257|NCT01986270|Drug|Eletriptan 40 mg|40mg oral
16123258|NCT01986270|Drug|Eletriptan 80 mg|80mg oral
16123259|NCT01986270|Drug|Sumatriptan 25 mg|25mg oral
16123260|NCT01986270|Drug|Sumatriptan 50 mg|50mg oral
16123261|NCT01986257|Behavioral|Emotion Regulation Group Therapy (ERGT).|
16123262|NCT01986231|Drug|Glucagon|Subjects will receive 8 doses of glucagon, each dose will be 2.0 mcg per kg. Glucagon will be reconstituted immediately prior to administration and each dose will be administered subcutaneously via syringe/needle. The first glucagon dose is at hour 17, second at hour 22, third at hour 24, fourth at hour 27, fifth at hour 29, sixth at hour 31, seventh at hour 33, eighth at hour 35.
16123263|NCT01986218|Drug|BMS-986115|
16123264|NCT01986205|Combination Product|Hyperbaric Oxygen|Hyperbaric oxygen (USP oxygen >99%) delivered in a hyperbaric chamber pressurized to 1.5 atmospheres absolute.
16123265|NCT01986205|Combination Product|Minimal pressure air|Room air delivered in a hyperbaric chamber with minimal pressurization.
16123266|NCT01986192|Drug|rivaroxaban|
16123267|NCT01986192|Drug|Warfarin|
16123268|NCT01986179|Other|Telephone Interpretation|Professional interpretation provided over the phone by a national network of certified medical interpreters
16123269|NCT01986179|Other|Video Interpretation|Professional interpretation provided over video by a national network of certified medical interpreters
16123270|NCT01986166|Drug|Cobimetinib|In Stage 1, cobimetinib will be administered at a starting dose of 80 mg q2w. The doses will be escalated to identify MTD. In Stage 2, participants will receive cobimetinib at the established MTD.
16123271|NCT01986166|Drug|MEHD7945A|MEHD7945A will be administered as IV infusion at a dose of 1100 mg q2w until disease progression or unacceptable toxicity.
16123272|NCT01986140|Device|PAXMAN Orbis Scalp Cooler|Treatment with Orbis scalp cooling cap
16123273|NCT01986140|Other|Control No treatment|No treatment to prevent hair loss
16123274|NCT01986127|Drug|Adalimumab|single intralesional administration during endoscopy process
16123275|NCT01986127|Drug|placebo|single intralesional administration during endoscopy
16123276|NCT01986114|Drug|SM-13496|
16123277|NCT01986101|Drug|Placebo|Placebo comparator
16123278|NCT01986101|Drug|SM-13496|SM-13496 20mg for Days 1-7 and beginning Day 8 flexibly dosed 20-60 mg/day for Weeks 2-6
16123279|NCT01986101|Drug|SM-13496|SM-13496 20 mg/day for Days 1-2, 40 mg/day for Days 3-4, 60 mg/day for Days 5-6, 80 mg/day on Day 7 and beginning Day 8 flexibly dosed 80-120 mg/day for Weeks 2-6
16123280|NCT01986088|Drug|Placebo|matching placebo
16123281|NCT01986088|Drug|Eletriptan 40 mg|40mg oral
16123282|NCT01986088|Drug|Eletriptan 80 mg|80mg oral
16123283|NCT01986088|Drug|Sumatriptan 50 mg|50mg oral
16123284|NCT01986088|Drug|Sumatriptan 100 mg|100mg oral
16123285|NCT01986075|Behavioral|Computer-assisted behavior therapy|TES is a computer-assisted therapy program delivered via effective informational and multimedia technologies, includes 32 core interactive, multimedia modules, beginning with basic cognitive behavioral relapse prevention skills (e.g. drug refusal skills) and moving on to improving psychosocial functioning, (e.g. employment status, social relations) and HIV risk reduction.
16123286|NCT01986075|Drug|Mixed amphetamine salts|80 mg/day of Adderall-XR
16123287|NCT01986075|Drug|Computer-assisted CBT plus placebo|Will receive computer -assisted CBT and placebo (instead of active Adderall-XR)
16123288|NCT01986062|Drug|AR11|
16123289|NCT01986062|Drug|Placebo|
16123290|NCT01986049|Drug|Bupivicaine|
16123291|NCT01986036|Dietary Supplement|Protein|Milk-Protein
16123299|NCT01986010|Biological|V160 High Dose plus MAPA 225 µg /dose IM|V160 plus MAPA administered as a 0.75 mL intramuscular injection
16123300|NCT01986010|Biological|V160 Maximum Dose IM|V160 administered as a 0.75 mL intramuscular injection
16123301|NCT01986010|Other|Placebo IM|Placebo administered as a 0.75 mL intramuscular injection
16123302|NCT01986010|Biological|V160 Medium Dose ID|V160 administered as a 0.1 mL intradermal injection
16123303|NCT01986010|Other|Placebo ID|Placebo administered as a 0.1 mL intradermal injection
16123304|NCT01985984|Radiation|Radiation alone|Radiation alone
16123305|NCT01985984|Radiation|Radiation in combination with systemic therapy|Radiation in combination with systemic therapy
16123306|NCT01985971|Radiation|PET/CT Imaging|
16123307|NCT01985958|Device|Radiation therapy|
16123308|NCT01985945|Other|Yoga|
16123309|NCT01985932|Device|MRI|
16123310|NCT01985919|Other|Obtaining human tissue for basic research or biospecimen bank|
16123311|NCT01985906|Procedure|Multiple overlapping uncovered stents|Endovascular management of complex aortic aneurysms with multiple overlapping uncovered stents
16123312|NCT01985906|Device|Uncovered stents|The number of uncovered stents implanted was determined by intraoperative angiography with the criterion that a decrease of velocity in the aneurysmal sac was achieved. Side branches, including segmental arteries and visceral branches, were covered wherever necessary.
16123313|NCT01985893|Drug|Lapatinib plus trastuzumab|Comparison of the safety and efficacy of lapatinib plus trastuzumab and lapatinib plus capecitabine.
16123314|NCT01985867|Dietary Supplement|Lactobacillus casei rhamnosus Lcr35|Eligible children will receive Lactobacillus casei rhamnosus Lcr35 (8×10^8 CFU, twice daily, orally for 4 weeks)
16123315|NCT01985867|Dietary Supplement|Placebo|Eligible children will receive placebo (maltodextrin), twice daily, orally for 4 weeks
16123316|NCT01985854|Drug|Propofol|
16123317|NCT01985854|Drug|Desflurane|
16123318|NCT01985841|Drug|Bevacizumb|Avastin
16123319|NCT01985841|Drug|5-Fluorouracil|5-FU
16123320|NCT01985841|Drug|Epirubicin|Farmorubicin
16123321|NCT01985841|Drug|Cyclophosphamide|Endoxan
16123322|NCT01985841|Drug|Docetaxel|Taxotere
16123323|NCT01985828|Radiation|CyberKnife|
16123324|NCT01985828|Other|Androgen Deprivation Therapy (ADT)|
16123325|NCT01985828|Radiation|Intensity Modulated radiation therapy (IMRT)|Per current standard of care
16123326|NCT01985815|Device|VC/VS stimulation|
16123327|NCT01985802|Other|Pacing|
16123328|NCT01985789|Drug|Diphenhydramine|
16123329|NCT01985789|Drug|cetirizine|
16123330|NCT01985789|Drug|desloratadine|
16123331|NCT01985789|Drug|placebo|
16123332|NCT01985776|Procedure|Exercise intervention|Functional stabilisation exercise for the trunk.
16123333|NCT01985776|Procedure|Exercise and e-stim|Functional stabilisation exercise for the trunk and electrical stimulation at the same time.
16123334|NCT01985763|Drug|Genistein|Genistein combined with FOLFOX or FOLFOX-Avastin
16123335|NCT01985750|Drug|d-cycloserine|250mg d-cycloserine or identical placebo given immediately to the first 4 sessions of a 6-week course pulmonary rehabilitation.
16123336|NCT01985750|Drug|placebo|"Other Names:
~comparison of d-cycloserine or placebo on enhancing the beneficial effects of pulmonary rehabilitation on breathlessness perception
~250mg d-cycloserine or identical placebo given immediately to the first 4 sessions of a 6-week course pulmonary rehabilitation"
16123337|NCT01985737|Other|Sample collection|
16123338|NCT01985724|Drug|Docetaxel|ARM A: Docetaxel 75 mg/m2 as an IV infusion over 1h on day 1 every 2 weeks for 4 cycles ARM B: Docetaxel 75 mg/m2 as an IV infusion over 1h on day 1 every 3 weeks for 6 cycles
16123339|NCT01985724|Drug|Epirubicin|ARM A: Epirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles
16123340|NCT01985724|Drug|Cyclophosphamide|ARM A: Cyclophosphamide 500 mg/m2 IV push on day 1 every 2 weeks for 4 cycles ARM B: Cyclophosphamide 600 mg/m2 IV push on day 1 every 3 weeks for 6 cycles
16123341|NCT01985724|Drug|5-fluoruracil|ARM A: 5-fluoruracil 500 mg/m2 IV push on day 1 every 2 weeks for 4 cycles
16123342|NCT01985724|Drug|Granulocyte-colony stimulating growth factor|rhG-CSF 5 μg/kg/d on days 3-10 after each cycle
16123343|NCT01985711|Device|web-based collaborative care|"Firstly ,24 weekly 40-minute web-based collaborative care plus usual diabetes outpatient care for 6months.
~Secondly, usual diabetes outpatient care for 6 months."
16123344|NCT01985711|Other|wait-list|Firstly ,usual diabetes outpatient care for 6 months. Secondly,24 weekly 40-minute web-based collaborative care plus usual diabetes outpatient care for 6months.
16123345|NCT01985711|Behavioral|usual diabetes outpatient care|
16123346|NCT01985698|Procedure|Robotic-assisted resection.|Robotic-assisted abdominoperineal resection.
16123347|NCT01985698|Procedure|Laparoscopic resection|Laparoscopic abdominoperineal resection
16123348|NCT01985685|Drug|Thiamine|200 mg IV thiamine
16123349|NCT01985672|Procedure|Frozen embryo transfer|Embryo transfer of frozen/thawed embryos after IVF/ICSI
16123350|NCT01985646|Procedure|surgery treatment|one staged pull-through left-colectomy
16123351|NCT01985646|Behavioral|anal dilation|anal dilation
16123352|NCT01985646|Behavioral|colonic lavage|colonic lavage
16123353|NCT01985646|Drug|oral probiotic|oral probiotic
16123354|NCT01985633|Biological|Mesenchymal stem cell suspension|About 8-10ml of bone marrow would be aspirated under strict aseptic precautions, cell fractionationated with Ficoll sol,centrifuged at 1100rpm for 20-30 mins. Buffy layer will be centrifuged again at 1100 rpm for another 20-30 mins. The pellet thus formed will be suspended in 5ml of culture medium. The nucleated stem cells thus isolated, will be incubated at 37deg.C under 5%CO2 in culture flasks for about 4-6weeks. Those cells adherent to flask removed with 0.05% trypsin-EDTA sol and characterised . Those positive for CD90 and CD105 and negative for CD45 and CD34 will be the mesenchymal stem cells. These will then be expanded to 10×106 for use.
16123355|NCT01985633|Biological|PRP|Twelve patients will be placed in supine position with knee in full extension and under full aseptic precautions 8-10 ml of platelet rich plasma would be injected by lateral approach with an 18-20 G needle.
16123356|NCT01985620|Behavioral|Educational intervention|
16123357|NCT01985607|Dietary Supplement|new extensively hydrolysed formula|
16123359|NCT01985594|Drug|utrogestan|Oral Tablet Utrogestan 400 mg daily for 2 days
16123360|NCT01985594|Drug|Nifedipine|Tablet Nifedipine 20 mg stat then 20 mg after 30 minutes if contraction persist and another 20mg after 30 minutes if contraction still persist followed by 10 mg three times daily for 2 days
16123361|NCT01985581|Drug|Guanfacine extended release|
16123362|NCT01985581|Drug|Placebo|
16123363|NCT01985581|Drug|Stimulant therapy|patient will continue to take stable dosage of usual stimulant therapy (Ritalin, Ritalin SR, Biphentin, Concerta, Vyvanse, Adderall or Dexedrine)
16123364|NCT01985568|Behavioral|Sequential BT|Both study arms (Standard BT and Sequential BT) will receive an identical 6 month group-based weight loss program, followed by an identical 6 month group-based weight maintenance program, followed by an identical 6 months of weight maintenance phone support. Both groups will also receive an identical 6 month exercise intervention. Groups will differ only in the timing of exercise initiation. Sequential BT will be asked not to begin exercise during months 0-6. They will receive a progressive exercise program and exercise behavior support during months 7-12.
16123365|NCT01985568|Behavioral|Standard BT|Both study arms (Standard BT and Sequential BT) will receive an identical 6 month group-based weight loss program, followed by an identical 6 month group-based weight maintenance program, followed by an identical 6 months of weight maintenance phone support. Both groups will also receive an identical 6 month exercise intervention. Groups will differ only in the timing of exercise initiation. Standard BT will begin exercise immediately upon starting the 6 month dietary weight loss intervention. They will receive a progressive exercise program and exercise behavior support during months 0-6.
16123366|NCT01985555|Drug|Volitinib(HMPL-504)|Volitinib(HMPL-504) is a tablet in the form of 25 mg ,100mg and 200 mg,oral,once daily or 2 times a day.
16123367|NCT01985542|Drug|birch pollen subcutaneous immunotherapy|birch pollen subcutaneous immunotherapy
16123368|NCT01985529|Other|Exercise|
16123369|NCT01985516|Other|Instillation into the urethra|5mL of 2% lidocaine gel will be instilled directly into the urethra 5 minutes before catheterization
16123370|NCT01985516|Other|pouring the gel on the catheter's tip|5mL of 2% lidocaine gel will be poured on the distal part of the catheter (from the distal tip to 10 cm proximally).
16123371|NCT01985490|Procedure|epiretinal membrane and internal limiting membrane removal|fluorescein angiography is performed before, 1 week, 3months and 6months after the epiretinal membrane and internal limiting membrane removal.
16123372|NCT01985477|Drug|Lenalidomide|"Phase I All Patients - Induction: Lenalidomide starting dose 25 mg by mouth 1 time every day on Day 1-21.
~Phase II Group A: Lenalidomide starting dose: Dose tolerated prior to enrollment.
~Maintenance Therapy: Phase I and Phase II Group A: Maintenance therapy lenalidomide at dose level tolerated at completion of cycle 3 for 21/28 days.
~Phase II Group B: Lenalidomide will be given as a single oral dose at the level patient was on at the time of progression on single agent lenalidomide prior to study enrollment."
16123373|NCT01985477|Drug|Dexamethasone|"Phase I All Patients - Induction: Dexamethasone starting dose 40 mg by mouth on Days 1,8,15,22.
~Phase II Group A: Dexamethasone starting dose: Dose previously on when progressing prior to study entry.
~Maintenance Therapy: Phase I and Phase II Group A: Dexamethasone at last tolerated dose on Days 1, 8, 15 and 22."
16123374|NCT01985477|Drug|All-Trans Retinoic Acid (ATRA)|"Phase I All Patients - Induction: ATRA starting dose 25 mg/m2 by mouth 2 times each day on Days 1-21.
~Phase II Group A: ATRA starting dose: MTD from Phase I.
~Maintenance Therapy: Phase I and Phase II Group A: ATRA at dose determined in Phase I for 14/28 days.
~Phase II Group B: All-Trans Retinoic Acid (ATRA) starting dose: MTD from Phase I.
~Maintenance Therapy Group B: ATRA at the dose determined in the Phase I portion of the trial for 14/28 days."
16123375|NCT01985464|Biological|Umbilical cord mesenchymal stem cells|
16123376|NCT01985451|Drug|Pemetrexe|Patients with relapsed PCNSL patients were treated with high-dose pemetrexed (900mg/m²).
16123377|NCT01985451|Drug|Temozolomide|Patients with relapsed PCNSL patients were treated with temozolomide (200mg/m² day 1-5,28).
16123378|NCT01985438|Procedure|percutaneous endoscopic gastrostomy tube placement|A 20 Fr PEG tube (Cook Medical, or Boston Scientific) will be placed endoscopically using Ponsky's pull technique, under conscious sedation, as a day-case procedure. A single dose of a prophylactic intravenous antibiotic (1.2g co-amoxiclav, 30 minutes prior to the procedure, unless evidence of penicillin allergy) will be given to all patients undergoing PEG tube insertion. Patients will be monitored for one hour prior to discharge following PEG tube insertion.
16123379|NCT01985438|Procedure|nasogastric tube placement|All nasogastric tubes will be inserted in a standard manner by a Gastroenterology Fellow or an Internal Medicine resident. Ordinarily, a 14 Fr, fine-bore NG feeding tube will be inserted at the bedside or, if unsuccessful, inserted under radiological guidance. A post-procedure abdominal x-ray will be performed to confirm correct placement of all NG tubes.
16123380|NCT01985425|Drug|Colchicine|
16123381|NCT01985425|Drug|Colchicine Placebo|
16123382|NCT01985399|Behavioral|Neuropsychological testing|Neuropsychological testing
16123383|NCT01985386|Dietary Supplement|GDS capsule with meal|GDS capsule with meal
16123384|NCT01985386|Dietary Supplement|Ferrous sulfate with meal|Ferrous sulfate with meal
16123385|NCT01985373|Drug|Intravenous immunoglobulin infusion|Blood samples are drawn before infusion with Nanogam 50 and Nanogam 100 mg/ml and IgG levels are determined to study PK
16123816|NCT01982136|Procedure|substitution urethroplasty (buccal mucosa)|
16123391|NCT01985347|Device|CPAP|Continuous positive airway pressure( CPAP)
16123392|NCT01985334|Drug|Glycopyrronium|Glycopyrronium 50 µg capsule for inhalation via SDDPI once per day
16123393|NCT01985334|Drug|SABA|Short-acting β2-adrenergic agonist (SABA) as per approved by each country and as prescribed for each patient, used as background therapy
16123394|NCT01985334|Drug|LABA|Long Acting Beta Agonist (LABA) as per approved by each country and as prescribed for each patient, used as background therapy
16123395|NCT01985334|Drug|Indacaterol maleate and glycopyrronium bromide|Indacaterol maleate and glycopyrronium bromide fixed dose combination (110/50 µg) capsule for inhalation via SDDPI, once a day
16123396|NCT01985334|Drug|LAMA|Long Acting Muscarinic Antagonist (LAMA) as per approved by each country and as prescribed for each patient, used as background therapy
16123397|NCT01985334|Drug|SAMA|Short-acting muscarinic antagonist (SAMA) as per approved by each country and as prescribed for each patient, used as background therapy
16123398|NCT01985334|Drug|ICS|Inhaled corticosteroid (ICS) as per approved by each country and as prescribed for each patient, used as background therapy
16123399|NCT01985321|Drug|ethanol/glycolic acid solution|ethanol/glycolic acid solution
16123400|NCT01985321|Drug|Placebo/Ethanol|ethanol solution
16123401|NCT01985308|Device|MRT-Active|
16123402|NCT01985308|Device|MRT-SHAM|
16123403|NCT01985295|Drug|pazopanib|A dose escalation trial of Pazopanib, starting at 400mg daily, orally in combination with the standard 25 x 2Gy preoperative radiotherapy in newly diagnosed extremity sarcoma patients. Dose of pazopanib will be escalated via 600mg to maximally 800mg. Overall treatment time of pazopanib is 40 days.
16123404|NCT01985282|Behavioral|Nutrition Status Questionnaires and Physicial Function Test|Nutrition status questionnaires will be administered, Physical functional status will be tested
16123405|NCT01985269|Other|Home visits|The participants' vital signs (blood pressure, temperature, pulse rate, respiratory rate, and arterial oxygen saturation) will be taken and a limited physical examination (e.g. oral cavity for thrush, Kaposi's lesions, ulcers and dehydration; skin for rash, herpes zoster and dehydration; eyes for jaundice and pallor, gross neurological function such as ability to walk without difficulty, presence of facial droop, one-sided body weakness etc.) conducted. The nurse will then review medications adherence before observing the study participant swallow their pills (antiretrovirals, anti-TB, antibiotics, and analgesics).
16123406|NCT01985256|Biological|Toca 511|All patients will receive Toca 511, a retroviral replicating vector that expresses the cytosine deaminase (CD) gene, intravenously and then intracranially. CD converts the antifungal 5-fluorocytosine (5-FC) to the anti-cancer drug 5-fluorouracil (5-FU) in cells that have been infected by the Toca 511 vector. Beginning approximately 6 weeks after the second administration of Toca 511,patients will begin 7-day course of oral 5-FC, repeated every 4 weeks for the duration of the study.
16123407|NCT01985256|Drug|Toca FC|
16123408|NCT01985243|Behavioral|Nutrition and agriculture|The intervention includes two components: (1) nutrition education on infant and young child nutrition, and (2) agriculture and small animal husbandry intervention to increase women's income and the accessibility of animal source foods for infants and young children.
16123409|NCT01985243|Behavioral|Iron-rich food & business literacy|The intervention includes two components: (1) a behavioural change intervention to improve school meals and increase the available iron in adolescents' diets, (2) savings & business literacy program for young female adolescents to encourage them to stay in school.
16123410|NCT01985230|Device|ReActiv8 Implantable Stimulation System implanted and activated.|
16123411|NCT01985204|Dietary Supplement|Iodine tablet|Iodine tablets containing 200 ug iodine as potassium iodate
16123412|NCT01985204|Dietary Supplement|Placebo tablet|Placebo tablet without iodine
16123413|NCT01985191|Drug|SAR405838|"Pharmaceutical form:capsule
~Route of administration: oral"
16123414|NCT01985191|Drug|Pimasertib|"Pharmaceutical form: capsule
~Route of administration: oral"
16123415|NCT01985178|Dietary Supplement|Omega-3 Fatty Acid Supplement|
16123416|NCT01985165|Drug|Imrecoxib|
16123417|NCT01985152|Drug|Azilsartan Trimethylethanolamine|
16123418|NCT01985152|Drug|Placebo|
16123419|NCT01985139|Behavioral|Computer-based tasks|Computer-based tasks designed to assess size and time discrimination capacities
16123420|NCT01985139|Biological|Blood sampling|Blood drawn for the measurement of circulating endocannabinoids concentrations
16123421|NCT01985126|Drug|Daratumumab 16 mg/kg (Part 1)|Daratumumab 16 mg/kg administered at weekly intervals (QW) for 8 weeks, then every 2 weeks (Q2W) for an additional 16 weeks, then every 4 weeks (Q4W) thereafter by intravenous infusion
16123422|NCT01985126|Drug|Daratumumab 8 mg/kg (Part 1)|Daratumumab 8 mg/kg every 4 weeks (Q4W) continuously by intravenous infusion
16123423|NCT01985126|Drug|Methylprednisolone|Administered in prophylactic doses intravenously (or equivalent in accordance with local standards) prior to and after study drug administration. Intravenous administration is preferred, but oral steroids may be substituted
16123424|NCT01985126|Drug|Acetaminophen|650 to 1000 mg administered in prophylactic doses by mouth prior to study drug administration.
16123425|NCT01985126|Drug|Diphenhydramine|25 to 50 mg administered in prophylactic doses by mouth (or equivalent in accordance with local standards) prior to and after study drug administration.
16123426|NCT01985126|Drug|Daratumumab (Part 2)|Based on the Part 1 response rate, Group A or B treatment will be selected as the treatment regimen for participants enrolled in Part 2.
16123427|NCT01985100|Other|hyperbaric oxygen chamber|
16123430|NCT01985074|Behavioral|Case-management intervention|The participants in the intervention group receives a nurse-managed case-management intervention that is regularly delivered by telephone or, when necessary, in person.
16123431|NCT01985061|Drug|BX2|
16123432|NCT01985061|Drug|BX3|
16123433|NCT01985061|Drug|BX4-Suspended|Suspended
16123434|NCT01985035|Behavioral|Diet|Reduction of energy intake in order to weight loss
16123435|NCT01985022|Behavioral|PII with IES|This is an individualized parent-implemented intervention (PII) offered weekly to teach parents how to embed strategies to support social communication skills for 25 hours a week within everyday routines, activities, and places for 9 months. In addition parent will receive twice weekly the IES condition of the study.
16123436|NCT01985022|Behavioral|IES|Parents will receive information, education, and support. They once a week for 75 minutes.
16123437|NCT01985009|Device|FibroScan® examination.|The study involves adults' patients with suspected Non-Alcoholic Fatty Liver Disease(NAFLD). The FibroScan® is a device equipped with probes (M+ or XL+), each of which consists of an ultrasonic transducer mounted on the axis of a mechanical vibrator. Liver stiffness and CAP measurements are performed on the right lobe of the liver with the patient in a dorsal decubitus and maximal abduction position. The procedure is non-invasive and painless.
16123438|NCT01984996|Device|Freedom ProFlor Inguinal Hernia Implant|
16123439|NCT01984983|Biological|Venezuelan Equine Encephalitis Virus DNA Vaccine Candidate|
16123440|NCT01984983|Other|0.9% saline placebo|
16123441|NCT01984970|Device|videolaryngoscope|McGrath Series 5 videolaryngoscope is one kind of portable videolaryngoscopes, which has been usde in both unexpected and anticipated difficult intubation.
16123442|NCT01984957|Procedure|Muscle biopsy|open muscular biopsy of the deltoid under local anaesthesia
16123443|NCT01984944|Other|Autistic functional exploration|"50 adults with urinary sample, core body temperature rhythm, Circadian rhythms assessed with actometer
~25 childs with urinary sample, Circadian rhythms assessed with actometer"
16123444|NCT01984944|Other|Control functional exploration|"50 adults with urinary sample, core body temperature rhythm, Circadian rhythms assessed with actometer
~25 childs with urinary sample, Circadian rhythms assessed with actometer"
16123445|NCT01984931|Drug|Trimebutine Maleate (NEWBUTIN SR 300 mg Tab)|Trimebutine Maleate (NEWBUTIN SR 300 mg Tab)is a noncompetitive spasmolytic agent. It possesses moderate opiate receptor affinity and has marked anti-serotonin activity especially on'M' receptors. A single dose of NEWBUTIN SR 300 mg Tab orally will be given one hour prior to the said operation time and another 300 mg orally as soon as the patient wakes post operatively.
16123446|NCT01984931|Drug|Metoclopramide hydrochloride monohydrate|
16123447|NCT01984918|Other|SMS reminder|A text message reminder via Short Message Service (SMS) will be sent to remind subjects 7-10 days before his colonoscopy appointment
16123448|NCT01984918|Other|Non-SMS reminder|No Stext message reminder via Short Message Service (SMS) will be sent
16123449|NCT01984892|Drug|Poly-ICLC|"Cycle 1-Weeks 1 and 2: 1mg Poly-ICLC intratumoral (IT) injections (t=6) into same lesion over 2 weeks.
~Weeks 3-9: 1mg Poly-ICLC 2x/week intramuscularly (IM) into thighs or upper arms.
~Week 10: No treatment. CT scan of chest, abdomen, pelvis and extremities or neck; possible MRI brain scan.
~Cycle 2-Weeks 11 and 12: 1mg Poly-ICLC IT injections (t=6) into same lesion over 2 weeks.
~Weeks 13-19 - 1mg Poly-ICLC 2x/weekly IM in thighs or upper arms.
~Weeks 20-26: no treatment. Week 26, evaluate response in absence of inflammation.
~Maintenance - Weeks 27-36: For patients with stable disease or response; IM poly-ICLC injections; evaluation of clinical and immune response. Week 38 repeat tumor assessment, optional biopsy
~Follow Up via phone every 3 months for 30months, after completion of treatments."
16123450|NCT01984879|Other|Survey with structured questionnaire form for inflammatory bowel disease patient group|For patients with inflammatory bowel disease, survey with structured questionnaire form is carried out.
16123451|NCT01984853|Other|OBSERVATIONAL REGISTRY|
16123452|NCT01984840|Device|Telemedicine|
16123453|NCT01984827|Drug|Moxifloxacin|"a single oral dose of 400mg Moxifloxacin plus a hyper-glycaemic clamp for 4 hours
~a single oral dose of 400mg Moxifloxacin plus C-peptide
~a single oral dose of 400mg Moxifloxacin
~placebo
~Oral doses of placebo and moxifloxacin will be administered by a Research Physician or Pharmacy staff member between 08:00 a.m. and 10:00 a.m."
16123454|NCT01984827|Other|hyper-glycaemic clamp|a hyper-glycaemic clamp only for 2 hours followed by a hyper-glycaemic clamp plus C-peptide for 2 hours
16123455|NCT01984814|Biological|Stem cell|Autologous bone marrow derived mononuclear cells were administered via intrathecal and intramuscular routes.
16123456|NCT01984801|Drug|0.3% GSK1940029 gel|200 mg of the gel will be applied to individual patches by using a spatula
16123457|NCT01984801|Drug|1% GSK1940029 gel|200 mg of the gel will be applied to individual patches by using a spatula
16123458|NCT01984801|Drug|0.3%/1% vehicle gel only|200 mg of the gel will be applied to individual patches by using a spatula
16123459|NCT01984801|Other|Sterile distilled water|200 µL of the solution will be applied to individual patches by using a pipette or syringe
16123460|NCT01984801|Other|0.5% SLS in sterile distilled water|200 µL of the solution will be applied to individual patches by using a pipette or syringe
16123461|NCT01984801|Other|0.1% SLS in sterile distilled water|200 µL of the solution will be applied to individual patches by using a pipette or syringe
16123462|NCT01984801|Other|Patch only|Only patch will be applied
16123463|NCT01984788|Drug|BCX4161|
16123464|NCT01984788|Drug|Placebo|
16123465|NCT01984775|Drug|GSK2894512 cream|GSK2894512 is a white to off-white cream that will be applied topically in 3 different concentrations (0.5% [5 milligram (mg)/gram (g)], 1% [10 mg/g], and 2% [20 mg/g]).
16123466|NCT01984775|Drug|Vehicle cream|Vehicle cream does not contain any active pharmaceutical ingredient.
16123467|NCT01984775|Drug|Positive control|Positive control contains sodium lauryl sulfate solution 0.1% (1 mg/g).
16123468|NCT01984775|Drug|Negative control|Negative control contains petrolatum.
16123469|NCT01984762|Procedure|Roux-en-Y gastric bypass|RYGBP=Roux-en-Y gastric bypass
16123470|NCT01984762|Procedure|sleeve gastrectomy|SG = sleeve gastrectomy
16123471|NCT01984749|Drug|Febuxostat|"Febuxostat will be taken once daily after breakfast (generally within 30 minutes after eating) but can be taken around the time of breakfast even if no food has been eaten. When the dose is to be increased, the principal or sub-investigator will carry out any required examinations and tests as needed.
~The starting dose of the investigational product (febuxostat) will be 10 mg/day.
~The dose will be increased to 20 mg/day at Week 4.
~The aim is to increase the dose to 40 mg/day at Week 8."
16123472|NCT01984736|Drug|Experimental: EVP-6124|
16123473|NCT01984723|Drug|Experimental: EVP-6124|
16123474|NCT01984710|Device|Medtronic Activa PC+S System|
16123475|NCT01984697|Biological|V503 (9-valent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] vaccine)|V503, a 9-valent HPV (Types 6, 11, 16, 18, 31, 33, 45, 52, 58) administered as a 0.5-mL intramuscular injection
16123476|NCT01984684|Drug|delafloxacin|
16123477|NCT01984684|Drug|vancomycin|
16123478|NCT01984684|Drug|aztreonam|
16123479|NCT01984671|Behavioral|Mobile Pain Coping Skills Training|
16123480|NCT01984658|Biological|Alecsat|The ALECSAT CBMP will be administered as single dose at week 4, 7 and week 10 which is considered an appropriate time for ALECSAT CBMP to strengthen the immune system and thus have the ability to kill tumour cells. It is the aim that the patients will receive three doses during the study period however, if the patient wish and it is recommended by the investigator, patients may receive more than three doses, continuing until progression or as judged by the Investigator. Continued treatment after the 24 week study period is only possible under the condition that no safety issues have been discovered. The interval between injections for continued treatment will be decided based on e.g. tumour response and clinical examinations.
16123481|NCT01984645|Other|Notification|Providers in the intervention group will receive a secure electronic notification when their patients are visited in the emergency department or admitted as an inpatient.
16123482|NCT01984632|Procedure|Single-port laparoscopic myomectomy|The aim of this study is to compare single-port laparoscopic myomectomy using barbed suture (experimental group) with multi-port laparoscopic myomectomy using barbed suture (control group) in terms of operative time (esp. suturing time).
16123483|NCT01984632|Procedure|Multi-port laparoscopic myomectomy|The aim of this study is to compare single-port laparoscopic myomectomy using barbed suture (experimental group) with multi-port laparoscopic myomectomy using barbed suture(control group) in terms of operative time (esp. suturing time).
16123484|NCT01984619|Device|Cryotherapy for the utilization of wrinkle reduction (iovera)|
16123485|NCT01984606|Drug|Empagliflozin|Empagliflozin once daily
16123486|NCT01984606|Drug|Placebo|Placebo matching empagliflozin
16123487|NCT01984606|Drug|Sitagliptin|Sitagliptin once daily
16123488|NCT01984606|Drug|Placebo|Placebo matching sitagliptin
16123489|NCT01984593|Other|Yoga|"The participants in the Yoga group will get a private doctors appointment (20 minutes) where they get instructions for two yoga exercises to perform at home 15 minutes twice a day.
~The two yoga exercises were:
~Left nostril breathing - deep breaths in and out through the left nostril while sitting or lying down, with the right nostril closed off by the right thumb or an earplug (about 11 minutes); and
~Spinal flex - movement that alternates between flexing the spine forwards (arching) and relaxing the spine back in time with deep breaths while sitting in a chair (about 4 minutes)."
16123490|NCT01984580|Drug|zinc gluconate|26.6 mg zinc BID (as zinc gluconate)
16123491|NCT01984567|Dietary Supplement|Vitamin E|Daily consumption of vitamin E capsules, 3 capsules of 268 mg daily, in total daily consumption of 804 mg
16123492|NCT01984567|Dietary Supplement|Lipoic acid|Daily consumption of lipoic acid capsules, 3 capsules of 200 mg daily, in total daily consumption of 600 mg
16123493|NCT01984567|Dietary Supplement|Control|Daily consumption of 3 placebo capsules
16123494|NCT01984541|Biological|Artemisia vulgaris|Four concentrations of Artemisia vulgaris allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.
16123495|NCT01984528|Biological|four differente concentrations of Alternaria alternata allergen extract, positive control and negative control|This concentrations will be tested in every patient in duplicate on the volar surface of the forearm.
16123496|NCT01984515|Behavioral|Referral Management System|"Referral Management System (RMS) will address patient-level barriers with the delivery of a 1-session cognitive behavioral therapy (CBT) intervention to identify and change treatment seeking beliefs that serve as an barrier to treatment engagement, including specific negative beliefs about EBP (e.g., talking about past trauma will be too difficult for me). RMS will address system-level barriers by tracking the progress of RMS referrals and contacting Veterans who have not followed thought on their chosen referral options. Primary Care staff will also be trained with simple scripts on how to address PTSD symptoms and make appropriate referrals based on VA/DoD Clinical Practice Guidelines for PTSD."
16123497|NCT01984502|Radiation|CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy|CyberKnife Accelerated Hemilarynx Stereotactic Radiotherapy
16123498|NCT01984489|Drug|Placebo|
16123499|NCT01984489|Drug|SHR117887|
16123500|NCT01984463|Drug|Fentanyl|Patients will receive an epidural bolus dose of 100 mcg of fentanyl followed by an infusion of epidural bupivacaine 0.1% and fentanyl 2 mcg/mL continued postoperatively until the surgical drains are removed or for a maximum of five days.
16123501|NCT01984463|Drug|Morphine|Patients will receive an epidural bolus dose of 3 mg of morphine followed by an infusion of epidural bupivacaine 0.1% and morphine 50 mcg/mL continued postoperatively until the surgical drains are removed or for a maximum of five days.
16123502|NCT01984450|Procedure|ACIC|"Autologous Collagen Induced Chondrogenesis (ACIC):
~ACIC is a single stage arthroscopic procedure. It is done as a day case procedure. The cartilage defect is debrided and implanted with a collagen + fibrin gel mixture under CO2 insufflation."
16123503|NCT01984450|Procedure|MCIC|"Mesenchymal Cell Induced Chondrogenesis (MCIC):
~MCIC is a single stage arthroscopic procedure. It is done as a day case procedure. BMAC is harvested intraoperatively and concentrated. It is then mixed with a fibrin gel and implanted under CO2 insufflation."
16123504|NCT01984450|Device|implant with a collagen + fibrin gel mixture|
16123505|NCT01984424|Drug|Atorvastatin|Atorvastatin was supplied as over-encapsulated 20 mg tablets
16123506|NCT01984424|Drug|Placebo to Atorvastatin|Placebo matching to atorvastatin supplied as over-encapsulated tablets
16123507|NCT01984424|Other|Placebo to Ezetimibe|Placebo matching to Ezetimibe supplied as over-encapsulated tablets.
16123508|NCT01984424|Drug|Ezetimibe|Ezetimibe was supplied as 10 mg tablets, over-encapsulated for blinding.
16123509|NCT01984424|Other|Placebo to Evolocumab|Placebo matching to evolocumab supplied as single-use prefilled autoinjector/pen(s)
16123510|NCT01984424|Drug|Evolocumab|Evolocumab supplied as single-use prefilled autoinjector/pen(s)
16123511|NCT01984411|Procedure|Radial Technical|Vascular Access for cardiac catheterization
16123512|NCT01984411|Procedure|Femoral Technical|Vascular Access for cardiac catheterization
16123513|NCT01984411|Drug|Omnipaque|
16124065|NCT01980082|Drug|Cefazolin|Antibiotic
16123514|NCT01984398|Drug|12.5 mg Androxal Formulation A|Single dose of 12.5 mg Androxal formulation A
16123515|NCT01984398|Drug|12.5 mg Androxal Formulation B|Single dose of 12.5 mg Androxal Formulation B
16123516|NCT01984398|Drug|25 mg Androxal Formulation A|Single dose of 25 mg Androxal formulation A
16123517|NCT01984398|Drug|25 mg Androxal Formulation B|Single dose of 25 mg Androxal formulation B
16123518|NCT01984372|Drug|insulin degludec|Frequency and timing of visits are based on normal clinical practice for patients with diabetes mellitus requiring insulin therapy.
16123519|NCT01984359|Other|Obtaining Human tissue|
16123520|NCT01984346|Device|AtriCure EPi-Sense-AF Guided Coagulation System with VisiTrax|Convergent Epicardial Endocardial Ablation Procedure
16123521|NCT01984346|Device|Endocardial RF Catheter ablation using Open Irrigated-tip RF Abaltion Catheter with unidirectional or bidirectional steering|Endocardial Catheter Ablation only
16123522|NCT01984333|Behavioral|Online cognitive training|Online cognitive training is a web-based video game that offers systematic training of response inhibition capabilities. Participants will be guided to make progress in an individually-tailored fashion to master increasingly difficult game levels.
16123523|NCT01984320|Procedure|ICSI|Long luteal GnRH agonist protocol: patients will receive GnRH agonist from day 21 of the previous cycle of stimulation and then on day 3 of the stimulation cycle they will start hMG injections with 225 IU/day. Folliculometry will start on day 6 stimulation by vaginal ultrasound. Estradiol levels will be measured on day 8, 10 and 12 of stimulation if appropriate. According to ultrasound and estradiol level patients will be randomized to either one of the study arms. When ready final triggering will be done by human chorionic gonadotropin (10000 IU) and oocyte collection is done at 36 hour from triggering. Embryo transfer is then done 3 days afterwards with ultrasound guidance.
16123524|NCT01984294|Drug|LDV/SOF|Ledipasvir/sofosbuvir (LDV/SOF) 90/400 mg FDC tablet administered orally once daily
16123525|NCT01984294|Drug|RBV|Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16123526|NCT01984294|Drug|GS-9669|GS-9669 tablet(s) administered orally once daily
16123527|NCT01984281|Behavioral|Pedometer-based physical activity prescription|After baseline assessments, both groups will receive a educational session, regarding important aspects of asthma plus a unsupervised exercise prescription (walking, 5 times per week, for at least 30 minutes). Only the experimental group will receive a pedometer-based physical activity prescription, consisting of targets (steps per day) to be achieved. The initial target will be determined based on the average of steps per day assessed during the baseline assessments plus 1000 steps. The targets will be biweekly. Both groups will be contact once a week (by phone) and will be asked to return for asthma control assessments once a month.
16123528|NCT01984268|Drug|ACTHAR|
16123529|NCT01984255|Drug|Arm A-Bavituximab 3mg/kg IV over 90 minutes weekly x 3 followed by Bavituximab 3mg/kg IV over 90 minutes weekly x 12 plus ipilimumab 3mg/kg IV|Bavituximab 3mg/kg IV over 90 minutes weekly x 3 followed by Bavituximab 3mg/kg IV over 90 minutes weekly x 12 plus ipilimumab 3mg/kg IV over 90 minutes every 3 weeks x 4. Total number of treated patients will be 16.
16123530|NCT01984255|Drug|Arm B-Ipilimumab 3mg/kg IV over 90 minutes day 1 followed three weeks later by ipilimumab every 3 weeks x 3.|Ipilimumab 3mg/kg IV over 90 minutes day 1 followed three weeks later by ipilimumab every 3 weeks x 3. Total number of treated patients will be 8.
16123531|NCT01984242|Drug|Atezolizumab (MPDL3280A), an Engineered Anti-PD-L1 Antibody|Atezolizumab will be administered according to the dosage schedule mentioned in the arm description.
16123532|NCT01984242|Drug|Bevacizumab|Bevacizumab will be administered according to the dosage schedule mentioned in the arm description.
16123533|NCT01984242|Drug|Sunitinib|Sunitinib will be administered according to the dosage schedule mentioned in the arm description.
16123534|NCT01984229|Drug|Alectinib|Alectinib will be administered as a single oral dose on Day 1 (Period 1) and Day 15 (Period 3) with an identical standardized meal (identical meal on Day 1 and Day 15 across all participants).
16123535|NCT01984229|Drug|Posaconazole|Posaconazole will be administered as a 400-mg BID oral dose after a high-fat meal on Days 8 to 14 (Period 2) and Days 15 to 18 or 21 (Period 3).
16123536|NCT01984216|Procedure|Roux-en-Y for the gastrojejunostomy reconstruction|
16123537|NCT01984216|Procedure|Billroth II for the gastrojejunostomy reconstruction|
16123538|NCT01984203|Other|Low Load Exercises|"All rotator cuff and scapular exercises are performed with 3 sets of 20 repetitions 3 times per week for 12 weeks. The load is set at around 60% of 1 RM (20 reps).
~The glenohumeral/postural corrective exercises are performed with 3 sets of 5 repetitions (The position is held for 15 seconds per repetition)."
16123539|NCT01984203|Other|Progressive Heavy Strength Exercises|"All scapular exercises are performed with 3 sets of 20 repetitions 3 times per week for 12 weeks. The load is set at around 60% of 1 RM (20 reps).
~The rotator cuff exercises are performed with 4 sets of gradually progressive loading and decreasing the repetitions performed in each set.
~Week 1: 15reps (70% 1RM) Week 2-3: 12 reps (75% 1RM) Week 4-5: 10 reps (80% 1RM) Week 6-8: 8 reps (85% 1RM) Week 9-12: 6 reps (90% 1RM)
~The glenohumeral/postural corrective exercises are performed with 3 sets of 5 repetitions (The position is held for 15 seconds per repetition)."
16123540|NCT01984177|Drug|Corticotropin-Releasing Hormone|Each subject will receive a single dose of Corticotropin-Releasing Hormone corticorelin on a single occasion, and a volume-matched saline injection on a second occasion. Corticorelin will be administered as an intravenous infusion over a 30- to 60-second interval at a dose of 1 ug/kg body weight. ~15 minutes after Corticorelin/saline injection, [11C]-(+)-PHNO will be administered followed by 90 minutes of PET scanning. Primary outcome measure ([11C]-(+)-PHNO) as well as Secondary outcome measures (self reported feeling, hormones and physiological measures) will be obtained before saline or Corticorelin/saline injection and for 90-120 minutes following injection.
16123541|NCT01984164|Drug|Candesartan|blinded
16123542|NCT01984164|Drug|Lisinopril|Blinded
16123543|NCT01984138|Drug|ESTRING|ESTRING (estradiol vaginal ring) is a slightly opaque ring with a whitish core containing a drug reservoir of 2 mg estradiol. Estradiol, silicone polymers and barium sulfate are combined to form the ring. When placed in the vagina, ESTRING releases estradiol, approximately 7.5 mcg per 24 hours, in a consistent stable manner over 90 days. ESTRING has the following dimensions: outer diameter 55 mm; cross-sectional diameter 9 mm; core diameter 2 mm. One ESTRING should be inserted into the upper third of the vaginal vault, to be worn continuously for three months.
16123544|NCT01984138|Drug|Replens|Replens should be applied vaginally, with a supplied applicator, three times each week.
16123545|NCT01984125|Other|Point-of-Care Prompt|
16123546|NCT01984112|Device|Locked plate|Osteosynthesis with philos plate, through deltopectoral approach and rotator cuff augmentation with inabsorbable poliester suture
16123547|NCT01984112|Device|Intramedullary locked nail|Intramedullary locked nail performed by antero-lateral transdeltoid minimally invasive approach and rotator cuff augmentation with inabsorbable poliester suture
16123548|NCT01984099|Drug|Methotrexate|Patients will be given a single course of methotrexate within fourteen days from molar evacuation.
16123549|NCT01984099|Drug|Vitamin B Complex|Patients will be given a placebo in a form of Vitamin B Complex (Bee ALL), intramuscularly or intravenously.
16123550|NCT01984086|Drug|Salbutamol Sulphate 150mcg UD-DPI Blister(1.6% blend)|Salbutamol Sulphate 150mcg UD-DPI will be supplied as blister containing a small quantity of powder comprising of a blend of salbutamol sulphate (micronized) and excipients
16123551|NCT01984086|Drug|Salbutamol Sulphate 200mcg UD-DPI Blister(1.6% blend)|Salbutamol Sulphate 200mcg UD-DPI will be supplied as blister containing a small quantity of powder comprising of a blend of salbutamol sulphate (micronized) and excipients
16123552|NCT01984086|Drug|Salbutamol Sulphate 250mcg UD-DPI Blister(1.6% blend)|Salbutamol Sulphate 250mcg UD-DPI will be supplied as blister containing a small quantity of powder comprising of a blend of salbutamol sulphate (micronized) and excipients
16123553|NCT01984086|Drug|Salbutamol Sulphate 200mcg UD-DPI Blister(1% blend)|Salbutamol Sulphate 200mcg UD-DPI will be supplied as blister containing a small quantity of powder comprising of a blend of salbutamol sulphate (micronized) and excipients
16123554|NCT01984086|Drug|Salbutamol Diskus 200mcg Blister|Salbutamol Diskus 200mcg will be supplied as blister strip contained within the Diskus device. Each blister contains a small quantity of powder comprising of a blend of salbutamol sulphate (micronized) and excipients
16123555|NCT01984086|Drug|Salbutamol MDI 100mcg|Salbutamol MDI 100mcg will be supplied as formulation of salbutamol sulphate (micronized) in propellant contained within the pressurised MDI device
16123556|NCT01984086|Drug|Salbutamol Sulphate UD-DPI Blister (selected from Part A)|Formulation will be determined depending on the outcome of Part A.
16123557|NCT01984086|Drug|Salbutamol Sulphate 250mcg UD-DPI Blister (selected from Part A)|Formulation will be determined depending on the outcome of Part A.
16123558|NCT01984086|Drug|Salbutamol Diskus 200mcg Blister without activated charcoal|Formulation will be determined depending on the outcome of Part A.
16123559|NCT01984086|Drug|Salbutamol Diskus 200mcg Blister with activated charcoal|Formulation will be determined depending on the outcome of Part A.
16123560|NCT01984086|Drug|Salbutamol MDI 100mcg without activated charcoal|Formulation will be determined depending on the outcome of Part A.
16123561|NCT01984086|Drug|Salbutamol MDI 100mcg with activated charcoal|Formulation will be determined depending on the outcome of Part A.
16123562|NCT01984073|Drug|ER Niacin Oral Fat Challenge|Extended release niacin 2000 mg at hour 0, followed by oral fat challenge at hour 1.
16123563|NCT01984073|Drug|IR Niacin Oral Fat Challenge|Nialor(R) 500mg or Placebo at hour 0, 2, 4, and 6. Oral fat challenge at hour 1 (one hour after first dose of immediate-release niacin)
16123564|NCT01984073|Other|Placebo Oral Fat Challenge|Placebo at hour 0. Oral fat challenge at hour 1, followed by placebo at hours 2,4,and 6
16123565|NCT01984060|Other|HOME-EX|"Motivational Counseling: The first session will be an hour face-to-face interview to establish a rapport with subjects, assess motives and competence. The rest will be 30 min. phone calls to assess week's performance and agree on an action plan for next 2 weeks.
~Exercise Intervention: Using the average number of steps for each subject from their baseline assessment, the targeted number of steps the subject needs to walk every day will be calculated. The individualized strength training exercise will target the upper and lower body. If possible, they will be encouraged to progressively increase from their individual baseline sets and repetitions to a maximum of 4 sets of 15 repetitions for each exercise"
16123566|NCT01984047|Drug|GSK3050002|GSK3050002 is a white to off-white lyophilized powder that will be reconstituted with sterile water for intravenous infusion. It is available in the concentrations of 0.1 milligram (mg)/kg, 0.5 mg/kg, 1 mg/kg, 5 mg/kg, 10 mg/kg and 20 mg/kg.
16123567|NCT01984047|Drug|Placebo|Placebo contains normal saline (0.9% sodium chloride) for intravenous infusion
16123568|NCT01984034|Behavioral|Educational Outreach Visits|The 3 members of the steering committee completed training regarding delivery of visits with the National Resource Center for Academic Detailing (Boston, MA). The other detailers were trained locally by this committee, with pre-training study assignments, and 12 hours of face-to-face training which included the principles of academic detailing, role-play, video-recording and feedback, discussion of the scientific content of each guideline, and knowledge assessment. To ensure consistency, the contents of each visit have been prepared in advanced by the committee and were used in the training sessions. Whenever possible, a single detailer will perform all three visits to the same doctor.
16123569|NCT01984034|Other|Passive Dissemination|Usual guideline implementation consists of passive dissemination by their publication on the National Health Directorate's website. Doctors in units randomized to the control group will be offered an unrelated training session (coding with the International Classification of Primary Care, second edition) as a token of good will for participating in the trial.
16123570|NCT01984021|Device|Acupuncture|
16123571|NCT01984021|Device|Sham acupuncture|
16123572|NCT01984008|Drug|Picosulfate sodium, magnesium oxide, citric acid|
16123573|NCT01983969|Drug|Azacitidine|Starting dose 15 mg/ m2 by vein on Day -11.
16123574|NCT01983969|Drug|Vorinostat|1000 mg by vein on Day -11 through Day -2.
16123575|NCT01983969|Drug|Gemcitabine|Loading dose 75 mg/m2 by vein followed by 22775 mg/m2 by vein on Day -8.
16123576|NCT01983969|Drug|Busulfan|Busulfan test dose 32 mg/m2 by vein either as outpatient before Day -12 or as inpatient on Day -11. Busulfan pharmacokinetics performed with test dose and first dose on Day -8. Doses on Days -6 and -5 adjusted to target an AUC of 4,000 microMol.min-1.
16123577|NCT01983969|Drug|Melphalan|60 mg/m2 by vein on Days -3 and -2.
16123578|NCT01983969|Drug|Dexamethasone|8 mg by vein twice a day from Day -11 AM to Day -2 PM.
16123579|NCT01983969|Other|Caphosol|Caphosol oral rinses 30 mL four times a day used from Day -9.
16123817|NCT01982136|Procedure|substitution urethroplasty (pedicled skin flap)|
16123580|NCT01983969|Drug|Glutamine|Oral glutamine, 15 g four times a day, swished, gargled and swallowed from Day -9.
16123581|NCT01983969|Drug|Pyridoxine|100 mg by vein or mouth three times a day from Day -1.
16123582|NCT01983969|Drug|Rituximab|375 mg/m2 by vein on Days -9.
16123583|NCT01983956|Behavioral|SENS model|Palliative care with a structured approach (SENS model) based on the bio-psycho-social-spiritual model of care, the WHO definitions of palliative care as well as the National Comprehensive Cancer Networks (NCCN) Practice Guidelines for Palliative Care. The approach supports the assessment of areas and complexity of concerns from the patient perspective, determines the priority and structures the support needed. The intervention is performed by palliative care physicians and nurses collaboratively. It is utilized as baseline assessment and afterwards integrated in each routine oncology care out-patient and in-patient visit. Depending on the goals it may be applied between routine visits. In addition, patients will receive usual oncology care throughout the study period.
16123584|NCT01983943|Dietary Supplement|Hydroxytyrosol, the active ingredient in olive oil.|A 40mg capsule will be taken once daily for 6 months.
16123585|NCT01983943|Dietary Supplement|Placebo|A 40mg placebo will be taken once per day for 6 months.
16123586|NCT01983943|Behavioral|Nutrition counseling|Nutrition counseling on eating a healthy diet will be offered once at baseline.
16123587|NCT01983943|Device|Endopat|An endopat test will be administered twice, once and baseline and once after 6 months of supplementation, to test endothelial function. This is a non-invasive test that takes about 15 minutes.
16123588|NCT01983930|Behavioral|Kundalini yoga and meditation|Participants will participate in a 60 minute yoga and meditation session weekly for 12 weeks and will be assigned a daily Kirtan Kriya meditation (12 minute duration) for 12 weeks.
16123589|NCT01983930|Behavioral|Memory Training|Participants will attend a weekly memory training class for 12 weeks as well as receive daily memory homework (12 minute duration) for the 12 weeks.
16123590|NCT01983917|Behavioral|Diabetes Mobile Application|
16123591|NCT01983904|Device|deep brain stimulation with short & long pulse width|surgical implantation for bilateral electrodes and stimulation using short and long pulse width
16123592|NCT01983891|Other|Cooking course|6-week nutrition education and cooking course
16123593|NCT01983878|Drug|Ramucirumab|Administered IV
16123594|NCT01983865|Other|Exposure to birch pollen|
16123595|NCT01983826|Dietary Supplement|Sodium Nitrate|Sodium Nitrate (1g/day) for 8 weeks
16123596|NCT01983826|Other|Placebo|Microcrystalline cellulose (daily) for 8 weeks
16123597|NCT01983813|Other|PHCVRS Intervention|"A clinical pharmacist at the PHCVRS will follow each participant in the PHCVRS arm for 12 months, including:
~Contact via email, phone or text every 2-4 weeks
~Assessment and counseling for medication adherence, side effects, and lifestyle modifications to decrease risk of cardiovascular disease.
~Collaborative communication with the participant's physician to address gaps in screening or therapy, update medication list, and recommend medication changes.
~Each participant in this arm will also have access to an online Personal Health Record that can be used to track medications, diagnosed conditions and laboratory values related to cardiovascular disease risk."
16123598|NCT01983813|Other|Personal Health Record|Participant will be able to access an online Personal Health Record for tracking medications and diagnosed conditions
16123599|NCT01983800|Drug|Isoflurane|
16123600|NCT01983800|Drug|Propofol/midazolam|
16123601|NCT01983774|Drug|Esomeprazole|
16123602|NCT01983774|Drug|Placebo|Sugar pill
16123603|NCT01983761|Drug|Fludarabine, Clofarabine, Busulfan, ATG, TBI (Myeloablative)|
16123604|NCT01983761|Drug|Fludarabine, Melphalan, ATG (Reduced Intensity)|
16123605|NCT01983748|Biological|Autologous Dendritic Cells loaded with autologous Tumor RNA|
16123606|NCT01983735|Drug|TELMINUVO Tab. (80/2.5mg)|"Fixed dose combination of Telmisartan 80mg and S-amlodipine 2.5mg QD 2 weeks.
~With the others investigation product placebo 1 tab QD 2 weeks."
16123607|NCT01983735|Drug|TELMINUVO Tab. (80/5mg)|"Fixed dose combination of Telmisartan 80mg and S-amlodipine 5mg QD 6 weeks.
~With the others investigation product placebo 1 tab QD 6 weeks."
16123608|NCT01983735|Drug|S-amlodipine 2.5mg|"S-amlodipine 2.5mg QD 2 weeks
~With the others investigation product placebo 1 tab QD 2 weeks."
16123609|NCT01983735|Drug|S-amlodipine 5mg|"S-amlodipine 5mg QD 6weeks
~With the others investigation product placebo 1 tab QD 6 weeks."
16123610|NCT01983722|Drug|Stiripentol|
16123611|NCT01983709|Biological|Allogeneic Human Mesenchymal Stem Cells|"This will be a dose escalation study. The first 3 subjects will receive a single dose of 1 x 10^6 cells/kg or a maximum dose of 1 x 10^8 total cells IV 4 days prior to undergoing a planned prostatectomy.
~The remaining subjects will receive a single dose of 2 x 10^6 cells/kg or a maximum dose of 2 x 10^8 total cells IV either 4 or 6 days prior to the planned prostatectomy, and if additional doses of MSCs are able to be expanded, up to 6 additional men will be enrolled with a plan to treat them 8 days prior to the prostatectomy."
16123612|NCT01983696|Other|5% oxygen concentration|the oocytes and embryos are cultured in the incubator with concentrations of 6% CO2,5%O2, and 89% N2
16123613|NCT01983683|Drug|Cadazolid|Cadazolid 250 mg as oral suspension twice daily.
16123614|NCT01983683|Drug|Vancomycin|Vancomycin 125 mg as oral capsules 4 times daily
16123615|NCT01983683|Drug|Cadazolid-matching placebo|Placebo matching cadazolid and administered orally twice daily
16123616|NCT01983683|Drug|Vancomycin-matching placebo|Placebo capsules matching vancomycin and administered orally 4 times per day
16123617|NCT01983670|Other|Temporal electrical stimulation|
16123618|NCT01983657|Drug|rhGM-CSF|GM-CSF will be given subcutaneously according to the rule in different groups.
16123619|NCT01983657|Procedure|Whole Lung Lavage(WLL)|using double lumen endotracheal tube (DLT) to selectively lavage one lung
16123620|NCT01983644|Device|RECO flow restoration device|RECO flow restoration device is a novel, self-expanding stent retriever designed to yield rapid flow restoration in acute cerebral ischaemia.
16123621|NCT01983644|Device|Solitaire FR flow restoration device|Solitaire FR flow restoration device has been approved by the FDA and CFDA.
16123622|NCT01983631|Other|Whole body vibration training|
16123623|NCT01983618|Procedure|Interscalene nerve block and catheter|
16123624|NCT01983618|Procedure|Interscalene catheter|
16123625|NCT01983605|Device|LARIAT Suture Delivery Device|LAA exclusion procedure
16124066|NCT01980082|Drug|Placebo|Placebo
16123626|NCT01983592|Other|Homeopathic medicine|Intervention must begin within 5 days of chemotherapy cycle completion. Intervention will continue until the next cycle of chemotherapy. The initial consultation will involve a verbal interview between the homeopath and the participant. The practitioner will then choose a single homeopathic remedy that will focus on the reduction of fatigue. Only one homeopathic remedy and potency will be administered at a given time. The participant will be asked to take the study medication at least 30 minutes before or after taking other medications, food and strong smelling substances.
16123627|NCT01983592|Other|Unmedicated lactose/sucrose globule|
16123628|NCT01983579|Procedure|Intraocular anti-VEGF injection|
16123629|NCT01983579|Device|SENSIMED Triggerfish|
16123630|NCT01983566|Drug|BI 207127 high fat|BI 207127 as a single dose after a high fat breakfast
16123631|NCT01983566|Drug|BI 207127 with Omeprazole|BI 207127 as a single dose after 4 days treatment of Omeprazole 40 mg once a day
16123632|NCT01983566|Drug|BI 207127|BI 207127 as a single dose in fasted state
16123633|NCT01983566|Drug|BI 207127 low fat|BI 207127 as a single dose after a low fat breakfast
16123634|NCT01983540|Biological|DTaP-IPV-Hep B- PRP~T + Prevenar + Rotarix vaccine|DTaP-IPV-Hep B-PRP~T vaccine at 2, 4, 6 months of age concomitantly with Prevenar and Rotarix (2 doses at 2 and 4 months of age), and a booster of the same investigational vaccine concomitantly with Prevenar (PCV7) at 12 to 24 months of age in a previous study
16123635|NCT01983540|Biological|DTaP- IPV-Hep B-PRP~T + Prevenar + Rotarix + Infanrix hexa vaccine|DTaP-IPV-Hep B-PRP~T vaccine at 2, 4, 6 months of age concomitantly with Prevenar and Rotarix (2 doses at 2 and 4 months of age) and a booster dose of Infanrix hexa vaccine with Prevnar at 12 to 24 months of age in a previous study.
16123636|NCT01983540|Biological|Infanrix hexa + Prevenar + Rotarix vaccine|Infanrix hexa vaccine at 2, 4, 6 months of age concomitantly with Prevenar and Rotarix (2 doses at 2 and 4 months of age), and a booster dose of DTaP-IPV-Hep B-PRP~T vaccine concomitantly with Prevenar vaccine concomitantly with Prevenar at 12 to 24 months of age in a previous study.
16123637|NCT01983527|Procedure|Arthrographic distention|Arthrographic distention of the glenohumeral joint with injection of 5 ml contrast, 15 ml local anaesthetic (Prilocaine) and up to 15 ml saline.
16123638|NCT01983527|Drug|Intra-articular corticosteroid Depo Medrol|Intra-articular injection of 1 ml (40 mg) Depo Medrol(Methylprednisolone Acetate Injectable Suspension)
16123639|NCT01983514|Drug|8IU intranasal oxytocin|
16123640|NCT01983514|Drug|24 IU intranasal oxytocin|
16123641|NCT01983514|Drug|1 IU intravenous oxytocin|
16123642|NCT01983514|Drug|Placebo|
16123643|NCT01983501|Drug|Tucatinib (ONT-380)|Given twice per day, orally
16123644|NCT01983501|Drug|T-DM1|Given intravenously once every 21 days
16123645|NCT01983475|Drug|Denosumab|In clinical trials, denosumab (Amgen Inc., Thousand Oaks, CA), has been shown to be more potent in reducing osteoclastosis and function than bisphosphonates.39,40 The rate of bone loss in the lower extremity at sites of interest in patients with acute SCI has been reported to be several-fold greater than the rate of bone loss in postmenopausal women not prescribed antiresorptive medications, which is about 3-5% per year.11,50,51 The dose of denosumab chosen for our protocol in patients after acute SCI will be the same dose that has been shown to be efficacious to treat postmenopausal osteoporosis (60 mg SQ q 6 months).
16123646|NCT01983475|Drug|Placebo (identical Denosumab volume of normal saline)|The placebo group will receive the identical volume of normal saline at parallel time points.
16123647|NCT01983462|Drug|Clonidine|
16123648|NCT01983462|Drug|Hydrochlorothiazide|
16123649|NCT01983462|Drug|Placebo|
16123650|NCT01983449|Drug|Dexamethasone Sodium Phosphate Injection, USP|Adventitial infusion of dexamethasone after angioplasty or atherectomy-based revascularization of the superficial femoral or popliteal artery.
16123651|NCT01983436|Other|Manual Lymphatic drainage|Manual lymphatic drainage of the face and the neck is a massage technique that aims to remove an edema of this anatomical region. The technique consists to stimulate the lymph nodes in order to accelerate the lymph flow and to achieve a specific massage to promote the entry of lymph nodes in the initial lymphatics. Massages follow anatomical pathways of vessels and of lymph nodes of the head and the neck. The technique should be smooth and painless.
16123652|NCT01983423|Device|Endometrial Biopsy|An endometrial biopsy is performed using a sampling device known as a pipelle catheter which is introduced into the uterine cavity. The inner core is withdrawn creating suctional pressure into the hollow bore of the cavity, which allows acquisition of endometrial tissue upon rotation in the cavity. This is removed and the tissue sent for pathologic examination.
16123653|NCT01983410|Behavioral|The risk assessment questionnaire|
16123654|NCT01983410|Other|Blood specimens|
16123655|NCT01983410|Other|tumor tissue samples will be requested|
16123656|NCT01983397|Other|Multicomponent training|The multicomponent training consisted of individuals subjected to a multicomponent exercise program: 5 minute warm up, 20 minutes of aerobic exercise, 15-20 minutes of strength exercises, 10 minutes of coordination, agility and balance exercises and 5 minute of cool-down.
16123657|NCT01983397|Other|Resistance training|The resistance training was subjected to a strength training using weight machines adapted for elderly. The protocol followed three sets of 10 to 12 maximal repetitions, moderate speed (two seconds for the shortening phase and three seconds for the elongation phase) and one minute for rest interval between sets.
16123658|NCT01983384|Other|Processed EEG-guided anesthetic depth|Investigators will undertake a randomized control trial in a cohort of older patients undergoing major non-cardiac surgery to receive either a control vs. an intervention of anesthesia as determined by a processed electroencephalogram
16123659|NCT01983371|Drug|Ferumoxytol|All study patients will receive a dose of ferumoxytol for the MRI. Ferumoxytol will be administered intravenously at a dose of 6 mg/kg, for a maximum dose of 510 mg.
16123660|NCT01983371|Other|Magnetic Resonance Imaging|All study patients will undergo a ferumoxytol-enhanced MRI in addition to any other ongoing care for colorectal cancer. Histopathologic analysis of lymph nodes will be the gold standard for determining lymph node status.
16123661|NCT01983358|Drug|JPI-289|PARP-1 inhibitor
16123662|NCT01983358|Other|Placebo|Placebo
16123818|NCT01982123|Diagnostic Test|SPECT/CT|Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT mid-radiation and post-radiation
16123664|NCT01983319|Device|active anodal transcranial Direct Current Stimulation (tDCS)|Anodal transcranial Direct Current Stimulation 1.5 mA in 30 minutes with CIMT
16123665|NCT01983319|Device|sham transcranial Direct Current Stimulation|sham transcranial Direct Current Stimulation 30 min with CIMT
16123666|NCT01983319|Behavioral|Constraint Induced Movement Therapy (CIMT)|2 weeks of CIMT
16123667|NCT01983306|Drug|SP-333 1 mg|Tablet
16123668|NCT01983306|Drug|SP-333 3 mg|Tablet
16123669|NCT01983306|Drug|SP-333 6 mg|Tablet
16123670|NCT01983306|Drug|Placebo|Tablet
16123671|NCT01983293|Device|QLV based implant strategy|
16123672|NCT01983293|Device|Standard of care implant strategy|
16123673|NCT01983280|Other|Healing Touch|
16123674|NCT01983267|Drug|cannabis|use of cannabis oil or cigarets
16123675|NCT01983254|Behavioral|coping skills training|6-session coping skills training program delivered by telephone w/ web augmentation
16123676|NCT01983254|Other|education program|web-based, ICU-specific education program
16123677|NCT01983241|Biological|Alpha-1 MP|
16123678|NCT01983241|Other|0.9% Sodium Chloride for Injection, USP|
16123679|NCT01983228|Behavioral|Intervention Condition|Intervention participants will complete 6 sessions of telephone coaching over a 10-12 week period, using a patient workbook with visual aids (e.g., diagram of the pain/inactivity cycle) and worksheets that they will complete during the counseling sessions. Participants are expected to receive approximately 180 minutes of total therapist time during the study.
16123680|NCT01983215|Device|Prevena vac|
16123681|NCT01983189|Procedure|transcranial magnetic stimulation|1 hz transcranial magnetic stimulation
16123682|NCT01983163|Other|Ketogenic diet (2.5 to 4:1)|Minimum ratio (2.5 to4:1) ketogenic diet causing ketosis will be given
16123683|NCT01983163|Other|Modified Atkin's diet|1:1 fixed ketogenic ratio Modified atkins diet will be given
16123684|NCT01983150|Behavioral|Crush the Crave Application|Crush the Crave (CTC) allows users to customize a quit plan by choosing a quit date and then deciding whether to quit now or cut down the number of cigarettes they smoke every week up to the quit date. CTC reminds users of money saved and health improvements. Based on contingency reinforcement, rewards are provided, which smokers can then choose to share with their social network via Facebook. Supportive text messages tailored to their specific quit plan and where they are in the quitting experience are provided. CTC allows tracking of daily smoking habits and cravings as well as craving triggers or psychosocial determinants by recording when, where and why smoking occurred. Online distractions to help smokers deal with cravings are provided.
16123685|NCT01983150|Behavioral|On the Road to Quitting - Self Help|"The control group will receive an evidence-based self-help guide known as On the Road to Quitting that has been developed by Health Canada for young adult smokers. Participants will be able to both view the self-help guide via the internet and will receive a printed version of the guide."
16123686|NCT01983137|Drug|Targinact® (oxycodone/naloxone)|
16123687|NCT01983124|Drug|Fotemustine + Vemurafenib|"Fotemustine 100mg/m2 IV on day 1 of each 21 day cycle. Number of cycles: until progression or unacceptable toxicity.
~Vemurafenib administered continuous oral dosing 960 mg twice daily or dose administered at time of progression since progression or unacceptable toxicity."
16123688|NCT01983111|Drug|buprenorphine|Dosage and administration: This one patch should be attached every 7 days.
16123689|NCT01983111|Drug|tramadol/acetaminophen|"Amount of drug ingredients
~: Acetaminophen 325 mg and Tramadol hydrochloride 37.5 mg in 1 tablet of this drug.
~Dosage and administration:
~Adjust dose depending on a patient's pain severity and treatment response. Starting at the initial dose of 2 tablets, usually administer 4 tablets per dose, twice daily. At a dosing interval of at least 12 hr, the daily dose should not exceed 8 tablets."
16123690|NCT01983085|Device|NOx dressing|The NOx dressing should be changed at least every 2 days.
16123691|NCT01983085|Device|Standard of Care|Dressing changed as per normal clinical practice
16123692|NCT01983072|Dietary Supplement|Infant formula|
16123693|NCT01983072|Other|Breastfeeding|Breastfeeding
16123694|NCT01983046|Drug|Three different mixture of acetate, butyrate and propionate and palcebo|
16123695|NCT01983033|Behavioral|Drop It training session|8 training sessions in group, sessions of 90 minutes, 7 sessions weekly, plus 1 session after 1 month
16123696|NCT01983033|Behavioral|treatment as usual|12 weeks of no intervention other than treatment as usual
16123697|NCT01983020|Drug|Lidocaine|
16123698|NCT01983020|Drug|Ketamine|
16123699|NCT01983020|Other|Saline|
16123700|NCT01983007|Procedure|High-intensity exercise|Performance of high-intensity exercise
16123701|NCT01983007|Procedure|Low-intensity exercise|Performance of low-intensity exercise
16123702|NCT01982994|Behavioral|Education/Daily Planning|"In this study, we will use educational materials delivered at the initial enrollment session and in daily facts of the day presented electronically to heighten awareness of (1) the risks of insufficient physical activity and excessive sedentary behavior, and (2) the expected beneficial outcomes of increased physical activity and reduced sedentary behavior. These messages should are designed to increase intentions to engage in physical activity and to limit sedentary behavior (motivational phase)"
16123703|NCT01982981|Other|water provision|perception behavioral change at the beginning and at the end of the intervention
16123704|NCT01982981|Other|Water provision|After participants are recruited, drink 2L of water for 8 weeks.
16123706|NCT01982955|Drug|Tepotinib|Tepotinib was administered at a dose range of 300 or 500 milligram (mg) (Phase 1b) and the recommended phase II dose (RP2D) determined in the Phase 1b in Phase II orally once daily over a 21-day cycle until progressive disease, intolerable toxicity, participants withdrawal from treatment. RP2D was determined as per safety monitoring committee (SMC) discretion.
16123707|NCT01982955|Drug|Gefitinib|Gefitinib was administered at a dose of 250 mg orally as once daily over a 21-day cycle until progressive disease, intolerable toxicity, participants withdrawal from treatment.
16123708|NCT01982955|Drug|Pemetrexed|Pemetrexed was administered at a dose of 500 milligram per square meter (mg/m^2) as intravenous infusion over 10 minutes on Day 1 of each 21-day cycle until progressive disease, intolerable toxicity, participants withdrawal from treatment or up to 6 cycles if pemetrexed maintenance is not considered.
16123709|NCT01982955|Drug|Cisplatin|Cisplatin was administered at a dose of 75 mg/m^2 as intravenous infusion over 2 hours on Day 1 of each 21-day cycle until progressive disease, intolerable toxicity, participants withdrawal from treatment or up to 6 cycles if pemetrexed maintenance is not considered.
16123710|NCT01982955|Drug|Carboplatin|Carboplatin was administered intravenously on Day 1 of each 21-day cycle at a dose of area under curve (AUC) 5 or AUC6 at the discretion of the Investigator until progressive disease, intolerable toxicity, participants withdrawal from treatment or up to 6 cycles if pemetrexed maintenance is not considered.
16123711|NCT01982942|Drug|ibudilast|Subjects randomly assigned to the ibudilast (MN-166) cohort will receive up to 100 mg/day for 96 weeks.
16123712|NCT01982942|Drug|Placebo oral capsule|Subjects randomly assigned to the placebo cohort will receive placebo oral capsule for 96 weeks.
16123713|NCT01982929|Procedure|TAP block (Bupivacaine 0.25% with epinephrine)|Ultrasound guided TAP blocks
16123714|NCT01982929|Procedure|Sham block control|A blunt needleless syringe was firmly pressed on either side of the abdomen.
16123715|NCT01982916|Drug|AGR tablet|
16123716|NCT01982916|Drug|Placebo (for AGR tablet and/or Active Comparator)|
16123717|NCT01982916|Drug|Active Comparator|
16123718|NCT01982890|Other|Control|No intervention as this group is simply followed prospectively.
16123719|NCT01982877|Behavioral|Four Supports Intervention|The Four Supports Intervention is a multi-faceted intervention involving the addition of a trained nurse/social worker interventionist to the patient's care team who delivers four kinds of support: emotional support, communication support, decision support, and anticipatory grief support.
16123720|NCT01982877|Behavioral|Educational Control Intervention|In addition to usual care, enrolled surrogates will receive two 15-minute education sessions about critical illness and mechanical ventilation on days 2 and 5, delivered by a research staff coordinator with education in critical care nursing.
16123721|NCT01982864|Drug|Gentamicin|"The decision to introduce the antibiotic is made during a session or between two sessions according to both the clinicians usual procedure.
~Depending on the number of injections, 8 to 10 blood samples will be drawn per patient. Clinical and biological data will be concomitantly collected (e.g., hemodialysis session duration, creatinine clearance…).
~The number of blood sampling and the time schedule will be adapted to the prescription and the possible follow-up of the treatment after the first injection. Whatever the time is between the first injection and the following dialysis session, a sampling will be performed 30 minutes after the end of the injection (T1), 8h after the end of the injection (T2), juste before (TAD), in the middle (TMD) and at the end of the dialysis (TFD)."
16123722|NCT01982851|Procedure|Epidural de novo|Patients will have the epidural space identified with a loss-of-resistance technique utilizing a 17-G Tuohy epidural needle. The epidural catheter will be inserted 5 cm into the epidural space. Epidural analgesia will be initiated with fentanyl 100mcg + bupivacaine 0.125% 10-20 mL (in divided doses). Maintenance epidural analgesia will then be initiated.
16123723|NCT01982851|Procedure|CSE|The epidural space will be located using the loss-of-resistance technique utilizing a 17-G Tuohy epidural needle. Patients will receive the intrathecal study drug via a 27-G pencil-point spinal needle utilizing the standard needle-through-needle technique. A 19-G epidural catheter will be inserted 5 cm in the epidural space. Maintenance epidural analgesia will then be initiated.
16123724|NCT01982838|Procedure|Epidural de novo|Patients will have the epidural space identified with a loss-of-resistance technique utilizing a 17-G Tuohy epidural needle. The epidural catheter will be inserted 5 cm into the epidural space. Epidural analgesia will be initiated with fentanyl 100mcg + bupivacaine 0.125% 10-20 mL (in divided doses). Maintenance epidural analgesia will then be initiated.
16123725|NCT01982838|Procedure|CSE|The epidural space will be located using the loss-of-resistance technique utilizing a 17-G Tuohy epidural needle. Patients will receive the intrathecal study drug via a 27-G pencil-point spinal needle utilizing the standard needle-through-needle technique. A 19-G epidural catheter will be inserted 5 cm in the epidural space. Maintenance epidural analgesia will then be initiated.
16123726|NCT01982825|Behavioral|Online intervention arm|See online intervention arm
16123727|NCT01982825|Behavioral|Online control arm|See online control arm
16123728|NCT01982812|Drug|Oral Levetiracetam|liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days
16123729|NCT01982812|Drug|Standard AED|Active comparitor, Standard AED
16123730|NCT01982799|Drug|Oral placebo|placebo
16123731|NCT01982799|Drug|Oral ibuprofen|Ibuprofen
16123732|NCT01982799|Drug|oral naproxen|naproxen
16123733|NCT01982799|Drug|oral acetaminophen/hydrocodone + ibuprofen|vicodin/ibuprofen
16123734|NCT01982786|Radiation|Image guided external beam radiotherapy with or without brachytherapy boost|image guided external beam radiotherapy (IGRT) or IGRT with high dose rate (HDR) brachytherapy boost
16123735|NCT01982786|Radiation|Brachytherapy|Brachytherapy boost
16123736|NCT01982773|Behavioral|Virtual Hope Box Smartphone App|Smartphone app
16123737|NCT01982773|Behavioral|Enhanced Treatment as Usual|Printed materials
16123738|NCT01982760|Drug|DDAVP|Patients Receiving DDAVP prior to operation
16123739|NCT01982747|Drug|MGN-Placebo|
16123740|NCT01982747|Drug|Placebo-MGN|
16123741|NCT01982734|Dietary Supplement|curcumin|80 mg curcumin were given orally either as native powder, native powder plus phytochemicals,micelles or micelles plus phytochemicals
16123742|NCT01982721|Device|Locking mechanism for prosthetic knee|
16123743|NCT01982695|Drug|Losartan|
16123744|NCT01982695|Drug|Lisinopril|
16123745|NCT01982682|Radiation|Total-Body Irradiation (TBI)|Undergo TBI
16123746|NCT01982682|Biological|Donor Lymphocyte Infusion (DLI)|Undergo DLI
16123747|NCT01982682|Drug|Cyclophosphamide|Given IV
16123748|NCT01982682|Procedure|Allogeneic hematopoietic stem cell transplantation (HSCT)|Undergo CD34+ selected allogeneic HSCT
16123749|NCT01982682|Drug|Mycophenolate mofetil|Given IV
16123750|NCT01982669|Other|No Intervention|
16123751|NCT01982656|Other|Massage|twenty minute massage intervention prior to bedtime (1900-2100), to be started after day 3 of admission for a minimum of 5 consecutive days and up to fourteen days. The massage will be conducted by an RN trained in massage technique that is not caring for the patient in a direct nursing role.
16124373|NCT01977482|Drug|rhEPO|rhEPO will be procured from local market
16123752|NCT01982643|Drug|naltrexone plus bupropion|Participants will receive a monthly injection of extended-release depot naltrexone (XR-NTX; as Vivitrol®) plus once-daily bupropion extended-release tablets (BRP; as Wellbutrin XL®) for 8 weeks.
16123753|NCT01982630|Drug|MK-8521|
16123754|NCT01982630|Drug|Liraglutide|
16123755|NCT01982630|Drug|Placebo|
16123756|NCT01982617|Other|Motivational Interviewing|
16123757|NCT01982617|Other|Psychoeducation|
16123758|NCT01982604|Drug|TI-Inhalation Powder A|Inhaled Insulin
16123759|NCT01982604|Drug|TI-Inhalation Powder B|Inhaled Insulin
16123760|NCT01982591|Other|laboratory biomarker analysis|Correlative studies
16123761|NCT01982591|Other|questionnaire administration|Ancillary studies
16123762|NCT01982578|Dietary Supplement|Genistein|Subjects will be randomized 1:1 to receive 360 days of double blind treatment of genistein.
16123763|NCT01982578|Other|Placebo|360 days of double blind treatment of placebo.
16123764|NCT01982565|Device|NOx dressing|The NOx dressing should be changed at least every 2 days.
16123765|NCT01982565|Other|Standard of Care|The clinician/podiatrist is free to use whichever treatment they would choose to use on the patient in their current clinical practice.
16123766|NCT01982539|Drug|Zipsor®|Administration of Zipsor® (liquid filled capsules) to patients with mild to moderate acute pain: 25 mg/every 6 hours/up to 4 days treament. Drug taken by mouth.
16123767|NCT01982513|Device|Ultrasound|The IVC will be visualized and images obtained using the intercostal window in both longitudinal and transverse planes.
16123768|NCT01982487|Biological|ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine|Given SC
16123769|NCT01982487|Drug|IDO1 inhibitor INCB024360|Given PO
16123770|NCT01982487|Other|laboratory biomarker analysis|Correlative studies
16123771|NCT01982487|Other|pharmacological study|Correlative studies
16123772|NCT01982474|Biological|Grass pollen extract|Grass pollen extract injected intralymphatically q 4 weeks x 3
16123773|NCT01982474|Other|Placebo injection|Normal saline injected intralymphatically q 4 weeks x 3
16123774|NCT01982461|Drug|Rosuvastatin|10mg,once daily
16123775|NCT01982461|Drug|Crestor®|10mg,once daily
16123776|NCT01982448|Drug|Cisplatin|
16123777|NCT01982448|Drug|Paclitaxel|
16123778|NCT01982435|Drug|Ranibizumab|Monthly injections of Intravitreal Ranibizumab 0.3 mg for 12 months in patients previously treated with Avastin for Diabetic Macular Edema.
16123779|NCT01982435|Drug|Ranibizumab|Three Monthly injections of Intravitreal Ranibizumab 0.3 mg in patients previously treated with Avastin for Diabetic Macular Edema. Then follow-up visits may be extended by 2 weeks for a total of 12 months.
16123780|NCT01982422|Behavioral|Whole Food, Nutrient-Dense Dietary Intervention|The dietary intervention will be a whole food, nutrient-dense diet which restricts processed foods high in food additives while optimizing micronutrient intake.
16123781|NCT01982422|Behavioral|Standard of Care|Normal standard-of-care for pregnancy.
16123782|NCT01982409|Biological|Live Attenuated Varicella Vaccine|
16123783|NCT01982396|Drug|ABC Twice Daily|
16123784|NCT01982396|Drug|ABC Once Daily|
16123785|NCT01982396|Drug|3TC Once Daily|
16123786|NCT01982396|Drug|3TC Twice Daily|
16123787|NCT01982383|Device|Micropulse Laser Treatment|
16123788|NCT01982383|Other|No treatment|
16123789|NCT01982357|Device|Laser Speckle Imaging and Diffuse Optical Spectroscopy|Laser Speckle Imaging and Diffuse Optical Spectroscopy
16123790|NCT01982344|Device|mini-exchange-room|
16123791|NCT01982331|Biological|LAIV H2N2|vaccine is delivered intranasally, .25 cc to each nostril at day 0 and day 28
16123792|NCT01982331|Other|Placebo|placebo delivered intranasally. .25cc to each nostril at day 0 and day 28
16123793|NCT01982318|Drug|VitroGro® ECM|
16123794|NCT01982318|Drug|Dulbecco's Phosphate Buffered Saline|
16123795|NCT01982305|Procedure|Simulator|Axillary nerve anatomy lecture plus training with the simulator.
16123796|NCT01982305|Procedure|Cadaver|Axillary nerve anatomy lecture plus training with the cadaver model.
16123797|NCT01982292|Drug|RLX030 (serelaxin)|RLX030 (serelaxin) was administered according to a weight-range adjusted dosing regimen at a nominal dose of 30 μg/kg/day as a continuous IV infusion for 48 hours.
16123798|NCT01982292|Drug|Placebo|Matching placebo of serelaxin was administered as a continuous IV infusion for 48 hours.
16123799|NCT01982266|Device|GRADION™ Hip Total Cartilage Replacement (TCR)™|
16123800|NCT01982253|Drug|Fasiglifam|Fasiglifam tablets
16123801|NCT01982253|Drug|Placebo to fasiglifam|Fasiglifam placebo-matching tablets
16123802|NCT01982240|Drug|Plecanatide|Plecanatide tablets QD for 12 weeks
16123803|NCT01982240|Drug|Placebo|Matching placebo tablets QD for 12 weeks
16123804|NCT01982240|Drug|Bisacodyl|Rescue medication
16123805|NCT01982227|Drug|indocyanine green|intravenous injection (0.25mg/kg) of the indocyanine green 24h before the surgery.
16123806|NCT01982214|Device|sedentary|No intervention
16123807|NCT01982214|Device|Vibration|Subjects will be submitted to the WBV for 5 to 20 minutes, 2 or 3 times a week with frequencies between 35 to 50 Hz while 12 months
16123808|NCT01982201|Drug|Lesinurad 400 mg|
16123809|NCT01982201|Drug|Tums 500 mg and 750 mg|
16123810|NCT01982201|Drug|MINTOX 10 mL|
16123811|NCT01982175|Biological|Alemtuzumab|"Escalation Phase: Initial Doses of Alemtuzumab 3mg/day by intravenous(IV) infusion until tolerated, then Alemtuzumab 10mg/day IV infusion until tolerated, then Alemtuzumab 30mg IV infusion until tolerated.
~Escalation to 30mg/day should be accomplished in 3~7 days.
~Stable dose Phase: Once 30mg/day infusion of Alemtuzumab was tolerated, then continue 3 times per week. The total duration of Alemtuzumab therapy including escalation and stable dose phase is 12 weeks.
~More than 30mg daily or 90mg weekly dose is prohibited
~--------------------------------------------------------------------------------"
16123812|NCT01982149|Genetic|Group 1|Perform gene expression studies of airway epithelium to correlate findings in the gene expression of nasal bronchial epithelium
16123813|NCT01982149|Genetic|Group 2|Correlate gene expression data from nasal and bronchial epithelium
16123814|NCT01982149|Genetic|Group 3|Correlated nasal epithelial gene expression with the ultimate diagnosis (by biopsy or surgery)
16123815|NCT01982136|Procedure|end-to-end urethroplasty|
16123819|NCT01982123|Procedure|Single Photon Emission Computed Tomography|Undergo 99mTc-MAA and 99mTc-DTPA SPECT/CT
16123820|NCT01982123|Radiation|Technetium Tc-99m Albumin Aggregated|Undergo 99mTc-MAA SPECT/CT
16123821|NCT01982123|Drug|Technetium Tc-99m DTPA|Undergo 99mTc-DTPA SPECT/CT
16123822|NCT01982110|Behavioral|Mindfulness based smoking cessation|Mindfulness based interventions are provided via a mobile phone application.
16123823|NCT01982110|Behavioral|Behavioral Smoking Cessation intervention|Behavioral Smoking Cessation intervention is a behaviorally based intervention is provided via a mobile phone application.
16123824|NCT01982097|Drug|Sorafenib (Nexavar, BAY 43-9006)|The patients under routine treatment of metastatic RCC with Nexavar before and after cytoreductive nephrectomy meeting the criteria of inclusion.
16123825|NCT01982071|Drug|Micafungin|Intravenous (IV)
16123826|NCT01982058|Other|communication intervention|
16123827|NCT01982058|Other|counseling intervention|
16123828|NCT01982058|Other|nutrition intervention|
16123829|NCT01982058|Other|questionnaire administration|
16123830|NCT01982045|Device|AttraX® Putty|Synthetic bone graft comprised of calcium phosphate granules and hydroxyapatite with an advanced biodissolvable polymer carrier that allows for better handling of the granules in putty form.
16123831|NCT01982045|Other|Autologous bone graft|Corticocancellous bone harvested from the iliac crest, with our without local bone obtained from decompression and/or preparation for fusion (facetectomy and denudement).
16123832|NCT01982032|Procedure|Transcatheter aortic valve replacement|Transcatheter aortic valve replacement
16123833|NCT01982032|Device|Medtronic CoreValve system|Transcatheter aortic valve replacement with the Medtronic CoreValve system
16123834|NCT01982032|Device|Edwards SAPIEN bioprosthesis|Transcatheter aortic valve replacement with an Edwards SAPIEN bioprosthesis
16123835|NCT01982019|Behavioral|Meal test taking and hormones measure including 26RFa|Meal test taking and blood sampling for the measure of 26RFa and classical hormones implicated in glucose control and obesity
16123836|NCT01982006|Procedure|Cataract surgery with Phacoemulsification|"Each patients randomized in the phaco arm will undergo a conventional cataract surgery.
~Corneal incisions will be manually performed using the same calibrated blade and at the same location for all procedures of one surgeon.
~Phacoemulsification machine used to perform cataract surgery in each center will be the same for all patients included in the center. The IOL (IntraOcular Lens) used in each center will be the same for all patients treated in the center."
16123837|NCT01982006|Device|Femtosecond laser-assisted cataract surgery|"Each patients randomized in the femto arm will undergo a femtosecond laser assisted cataract surgery.
~Corneal incisions will be performed by the laser. Number, size and location of the incisions must be the same than in the phaco arm for all patients treated by one surgeon.
~Phacoemulsification machine used to remove the liquefied lens will be the same than in the phaco arm The IOL used in each center will be the same than in the phaco arm"
16123838|NCT01981993|Biological|Urinary proteomic analysis|
16123839|NCT01981980|Other|Carboxytherapy|Carboxytherapy was performed on the right side and RF on the left side. CA was administered using the beveled end of a 30G ½ needle introduced in the skin in an angle of approximately 30ºC and delivered at a velocity of 40 mL/min. The total quantity of CO2 infused was approximately 20 mL (0,3 to 0,6 mL/kg of patient's body weight) encompassing the whole delimited area.
16123840|NCT01981980|Other|Radiofrequency|The epidermal temperature was controlled using an infrared thermometer monitored to reach 40ºC and treatment time was of five minutes starting after having reached this temperature.
16123841|NCT01981967|Biological|IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine|0.5 mL, Subcutaneous.
16123842|NCT01981967|Biological|IMOJEV®: Live attenuated Japanese encephalitis chimeric virus vaccine|0.5 mL, Subcutaneous.
16123843|NCT01981954|Drug|Solifenacin succinate|Oral suspension
16123844|NCT01981941|Drug|Gabapentin enacarbil|Oral
16123845|NCT01981928|Drug|ASP7962|Oral
16123846|NCT01981928|Drug|Placebo|Oral
16123847|NCT01981915|Procedure|IPPB|Lung insufflation with positive pressure using IPPB up from 10 to 40 mbar in 5 mbar increments and consecutive measurement of the insufflation volume
16123848|NCT01981915|Procedure|LIAM|Lung insufflation using the Lung Insufflation Assist maneuver of the Ventilogic LS mechanical ventilator (Weinmann Germany) with positive pressure up from 10 to 40 mbar in 5 mbar increments and consecutive measurement of the insufflation volume
16123849|NCT01981902|Device|Non-Invasive Optical Spectroscopic|Non-Invasive Optical Spectroscopic
16123850|NCT01981889|Drug|Prednisone|Participants will be started on oral prednisone 40mg/day for two weeks as per standard of practice in IBD management, before starting a tapering course.
16123851|NCT01981863|Drug|Epsilonaminocaproic acid|One group receives Epsilonaminocaproic acid, 10 gr IV bolus, followed by 1 gr/hr. Second group receives placebo.
16123852|NCT01981863|Drug|Placebo|Placebo administered in same volume as in experimental arm.
16123853|NCT01981850|Biological|PRM-151|IV infusion
16123854|NCT01981850|Drug|Ruxolitinib|IV infusion
16123855|NCT01981837|Drug|ALN-TTRSC (revusiran) for subcutaneous administration|
16123856|NCT01981811|Drug|Aripiprazole|
16123857|NCT01981811|Device|Ingestible Event Marker (IEM)|
16123858|NCT01981798|Behavioral|Physiotherapy and occupational therapy|Members of the training group received 9 units of physiotherapy and 2 units of occupational therapy, each with a duration of one hour. Every patient of the IG was trained to perform a neck or back intervention program specifically suited to his/her needs. The training was conducted in a single session by one of three experienced physiotherapists (with mean work experience of 6 years). After this training the patients completed eight group training units consisting a maximum number of 8 participants, each unit with a duration of one hour, over a maximum period of six weeks.
16123859|NCT01981772|Drug|4% lidocaine with 1:100,000 epinephrine|see arm/group description
16123860|NCT01981772|Drug|4% buffered lidocaine with 1:100,000 epinephrine|see arm/group description
16123861|NCT01981759|Drug|D-Cycloserine|Participants will receive 10 administrations of 50 mg of D-Cycloserine by mouth one hour before CBT sessions, weekly, in weeks 3-12.
16123862|NCT01981759|Other|Placebo|Participants will receive 12 weekly administrations of placebo by mouth 1 hour before CBT sessions, from weeks 1-12.
16124572|NCT01975714|Drug|Preservative-free bimatoprost|
16123863|NCT01981759|Behavioral|Cognitive Behavioral Therapy|Participants will engage in a Cognitive Behavioral Therapy treatment plan designed for psychotic delusions. The program will consist of 12 one hour sessions, once weekly from study week 1-week 12.
16123864|NCT01981746|Procedure|Adductor canal block with ropivacaine 0.1%|US-guided adductor canal block
16123865|NCT01981733|Device|geko|The geko is a neuromuscular stimulator device, which when applied stimulates the common peroneal nerve
16123866|NCT01981720|Biological|PRX-102 (pegunigalsidase alfa)|PRX-102 1 mg/kg every 2 weeks
16123867|NCT01981707|Device|F-Choline-PET|
16123868|NCT01981694|Drug|PF-06649751|Single doses, given by oral solution, starting at 0.25 mg up to a possible maximum of 7.5 mg. The subject will have been fasted for 10 hours prior to the single dose. For each dosing period, 3 subjects will be given a placebo as a comparator. One dose will be given in the fed state.
16123869|NCT01981694|Drug|PF-06649751|It is believed that the maximum tolerated dose of this compound the eye blink rate (EBR) will also increase. This arm will use EBR measurement technology to verify this hypothesis. In each dosing period, 5 subjects will be given a placebo as a comparator.
16123870|NCT01981681|Drug|PF-06263726|Subjects will receive dose strength of 2% PF-06263276 (1.14 mg) and matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to two separate contralateral 20 cm2 areas on the back.
16123871|NCT01981681|Drug|PF-06263726|Subjects will receive dose strength of 4% PF-06263276 (2.28 mg) and matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to two separate contralateral 20 cm2 areas on the back.
16123872|NCT01981681|Drug|PF-06263726|Subjects will receive dose strength of 2% PF-06263276 (11.4 mg) in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back.
16123873|NCT01981681|Drug|Placebo|Subjects will receive dose strength of 2% PF-06263276 (11.4 mg) matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back.
16123874|NCT01981681|Drug|PF-06263726|Subjects will receive dose strength of 4% PF-06263276 (22.8 mg) in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back.
16123875|NCT01981681|Drug|Placebo|Subjects will receive dose strength of 4% PF-06263276 (22.8 mg) matching placebo in topical formulation (2.5 µL/cm2) to be applied twice daily to a 200 cm2 area on the back.
16123876|NCT01981668|Drug|cabazitaxel|Concurrent cabazitaxel, radiotherapy and Eligard for 3 years
16123877|NCT01981655|Drug|0.5M Sodium lactate|A bolus of 0.5M Sodium lactate of 3 ml per kg BW is administered in 15 minutes, followed by a continuous infusion with 1 ml per kg per hour for 24 hours, i.e. in total 27 ml per kg over 24 hours
16123878|NCT01981655|Drug|Hartmann's solution|Hartmann's solution of 3 ml per kg BW is administered in 15 minutes, No infusion thereafter i.e. in total 3 ml per kg over 24 hours
16123879|NCT01981642|Other|Recording of LVAD data during routine visits and daily life.|Noninvasive diagnostic intervention.
16123880|NCT01981642|Other|Recording of daily activity using wristwatch accelerometers.|Noninvasive diagnostic intervention.
16123881|NCT01981629|Device|USCOM|The USCOM device will be used in addition to cardiac ultrasound in patients with shock.
16123882|NCT01981616|Drug|Vedolizumab|Vedolizumab for intravenous infusion
16123883|NCT01981616|Drug|Placebo|Placebo intravenous infusion
16123884|NCT01981616|Biological|Hepatitis B vaccine|
16123885|NCT01981616|Biological|Oral cholera vaccine|
16123886|NCT01981603|Other|navigator|
16123887|NCT01981590|Device|Stimulating the phrenic nerve intravenously using high frequency electrical pulses using an EP catheter connected to external pulse stimulator.|Intravenously stimulating the phrenic nerve with an EP catheter using high frequency electrical pulses as generated by the model 19039 external neurostimulator.
16123888|NCT01981564|Behavioral|Asthma Express Intervention|Asthma Express clinic visit for asthma education + nurse home visit
16123889|NCT01981564|Behavioral|Standard Asthma Education Control Group|Asthma Express home nurse visits for asthma education
16123890|NCT01981551|Drug|PF-03084014|Treatment with the selective small-molecule >=-secretase inhibitor PF- 3084014 caused significant tumor shrinkage in patients with unresectable desmoid tumors in an early-phase clinical trial.
16123891|NCT01981525|Drug|Metformin|Treatment will be administered primarily on an outpatient basis. Patients will be instructed to take 500 mg metformin by mouth 1, 2 or 3 times a day or 1000 mg twice per day depending on dose level. Patients will receive metformin at level 1 dose for 2 weeks. If dose is tolerated, patient will receive level 2 dose for 2 weeks and if tolerated will escalate to level 3 dose, and if tolerated will escalate to level 4 dose. Metformin will be taken for 14 weeks.
16123892|NCT01981499|Drug|PF-05180999|Ascending single oral doses of 120, 240, and 420 mg modified-release tablets
16123893|NCT01981499|Drug|Placebo|Placebo tablets
16123894|NCT01981499|Drug|120 mg MR PF-05180999|Single 120 mg dose administered as modified release formulation
16123895|NCT01981499|Drug|360 mg MR PF-05180999|Single 360 mg dose administered as modified release formulation
16123896|NCT01981499|Drug|10 mg cetirizine|Single 10 mg dose of cetirizine
16123897|NCT01981499|Drug|Placebo|Placebo tablets
16123898|NCT01981486|Drug|Placebo Tablets|BID modified-release tablets
16123899|NCT01981486|Drug|PF-05180999 Tablets|BID modified-release tablets (20 to 240 mg BID)
16123900|NCT01981473|Other|no intervention|
16123901|NCT01981473|Other|no intervention|
16123902|NCT01981473|Other|no intervention|
16123903|NCT01981460|Procedure|Methylene blue and light treatment|Methylene blue and light treatment for 17 minutes are done twice over 1 week intervals.
16123904|NCT01981447|Drug|IV Lacosamide|Lacosamide administered intravenously over 15 or 30 minutes, depending on study arm, to patients with epilepsy.
16123905|NCT01981434|Other|Video game based obesity education|The intervention will be in the form of a videogame in which both parent and their children will participate. The game incorporates lessons from research on avatars (e.g., the Proteus Effect), and game dynamics to explore ways to increase healthy eating and exercise.
16123906|NCT01981408|Drug|[^14C]-LY2801653|Administered orally
16123907|NCT01981395|Drug|Fenobam|Fenobam 150 mg will be administered and subjects will be monitored for up to 8 hours. During the study day questionnaires will be administered, blood will be drawn a testing site will be marked and pain testing and heat/capsaicin sensitization will be measured.
16123908|NCT01981395|Drug|Placebo|A placebo will be administered and subjects will be monitored for up to 8 hours. During the study day questionnaires will be administered, blood will be drawn a testing site will be marked and pain testing and heat/capsaicin sensitization will be measured.
16123909|NCT01981369|Drug|Dexmedetomidine|Intravenous sedation with dexmedetomidine
16123910|NCT01981369|Drug|Propofol|Intravenous sedation with propofol
16123911|NCT01981369|Procedure|Infraclavicular block|All patients will receive ultrasound guided infraclavicular block with the standard protocol of the Block Room in St. Joseph Hospital.
16123912|NCT01981356|Behavioral|Acceptance and Commitment Therapy|"The goal of ACT is to help the patient increase psychological flexibility, a core component of mental health and well-being. ACT teaches clients to be mindfully aware but nonreactive to delusions/ hallucinations and to increase willingness to
~experience associated distressing emotions while simultaneously engaging in meaningful behavioral actions.
~Patients expand their repertoire of behaviors to live according to their values and to pursue valued goals, thereby increasing adaptive functioning and quality of life."
16123913|NCT01981356|Other|Treatment as Usual (TAU)|All patients admitted to the acute psychiatry unit are administered anti-psychotic and/or other psychotropic medication during their inpatient stay. Patients participate in standard milieu therapy on the unit (group and activities therapies, and individual therapy as needed). Therapy on the unit focuses on psycho-education about illness, symptom identification, mood management techniques, stress reduction, and relapse prevention. Patients also receive unstructured individual therapy and case management as appropriate.
16123914|NCT01981343|Dietary Supplement|A-F Betafood|
16123915|NCT01981343|Other|Placebo|
16123916|NCT01981330|Biological|aMSC|aMSC injected into the vocal fold of the patient
16123917|NCT01981330|Biological|aMSC+hyaluronan gel|aMSC+ hyaluronan gel is injected into the patients vocal fold
16123918|NCT01981317|Behavioral|Stepped Care Cognitive Behavioral Therapy|
16123919|NCT01981317|Behavioral|Cognitive Behavioral Therapy|
16123920|NCT01981291|Procedure|Intraneural Injection for Subgluteal Sciatic Nerve Block|"The injection will start as the needle penetrates the outermost discernible layer of the nerve (epineurium) under ultrasound guidance. The injection will be adjudicated as intraneural if nerve cross section expansion and a reduction in echogenicity are observed.
~Short-axis real-time ultrasound imaging will be used, with an in-plane needle approach."
16123921|NCT01981291|Procedure|Perineural Injection for Subgluteal Sciatic Nerve Block|"The injection will start as the needle indents the outermost discernible layer of the nerve (epineurium) under ultrasound guidance. The injection will be adjudicated as intraneural if the drug infiltrates the space between the epimysium of the surrounding muscles and the outer epineurium of the sciatic nerve.
~Short-axis real-time ultrasound imaging will be used, with an in-plane needle approach."
16123922|NCT01981291|Procedure|Femoral Nerve Block|Patients will receive an ultrasound-guided femoral nerve block using a short- or long-acting local anesthetic, as deemed indicated.
16123923|NCT01981291|Procedure|Patient-controlled postoperative analgesia|Patients will receive a patient-controlled intravenous or perineural catheter-based analgesia, depending on their preference and the anesthesiologist's indication.
16123924|NCT01981291|Drug|Mepivacaine|Thirty milliliters of 1.5% (wt/vol) mepivacaine will be used for the sciatic nerve block.
16123925|NCT01981278|Drug|Tapentadol ER 250-mg TRF tablet|Participants will receive single oral dose of tapentadol ER 250-mg TRF tablet on Day 1 of each treatment period.
16123926|NCT01981278|Drug|Tapentadol ER 250-mg PR2 tablet|Participants will receive single oral dose of tapentadol PR2 250-mg tablet on Day 1 of each treatment period.
16123927|NCT01981252|Device|Ulthera® System Treatment|Focused ultrasound energy delivered below the surface of the skin
16123928|NCT01981239|Device|VFSS|VFSS was perfomred one day before or after the voice sampling in the same patients according to the guideline of modified Longeman's protocol.
16123929|NCT01981226|Device|Extracoporeal shock wave|Extracoporeal shock wave, 3000 shots/time, once a week for 3 weeks, treatment duration:30 minutes/time, shock wave freqency：2-4Hz, energy level:0.8-1.0 mJ/mm2
16123930|NCT01981200|Other|Resistance training in AECOPD|The patients begin training on day 1 of admittance. The training consists of knee extension performed in the sitting position on the bed with a 90 degrees of flexion of the knees. The weight cuffs are tired to the angles with a weight corresponding to 10 RM (the weight lifted 10 times). The weights and exercises are subjected to supervision on daily basis by the physiotherapist. The weight is increased after every set of training if more than 10 rep. can be performed with a given weight. Limitations to exercise is also recorded along with the degree of dyspnoea as assessed by the Borg CR10, possible oxygen supplementation and saturation is recorded before and following exercise.
16123931|NCT01981187|Drug|LGX818|LGX818 will be dosed on a flat scale of 300 mg (e.g., 3 x 100 mg capsules) once daily on a continuous dosing cycle. A complete treatment cycle is defined as 28 days. There will be no breaks between dosing cycles.
16123932|NCT01981174|Procedure|30-gauge needle|
16123933|NCT01981174|Procedure|32-gauge needle|
16123934|NCT01981161|Procedure|biological samples and clinical data|
16123935|NCT01981148|Device|Fluorescence lifetime ophthalmoscope|All patients and healthy subjects will be imaged with the fluorescence lifetime ophthalmoscope
16123936|NCT01981135|Other|Clean Air|Each subject will be exposed to clean air for 2 hours. The exposure atmosphere will be at a temperature between 31-34oC (88-93 oF) and approximately 40 + 10% RH. Subjects will exercise on a bike. Each exercise session will consist of a 15 minute exercise interval at a level of up to 25 L/min/m2BSA followed by a 15 minute rest period.
16123937|NCT01981135|Other|Ozone|Each subject will be exposed up to 0.3ppm ozone for 2 hours. The exposure atmosphere will be at a temperature between 31-34oC (88-93 oF) and approximately 40 + 10% RH. Subjects will exercise on a bike. Each exercise session will consist of a 15 minute exercise interval at a level of up to 25 L/min/m2BSA followed by a 15 minute rest period.
16123938|NCT01981122|Biological|sipuleucel-T|Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
16123939|NCT01981122|Drug|enzalutamide|Enzalutamide is an androgen receptor inhibitor. It is indicated for the treatment of patients with mCRPC who have previously received docetaxel. The enzalutamide dose used in this study will be 160 mg orally once daily.
16123940|NCT01981096|Behavioral|Fibromyalgia integrative training|Combined intervention with neuromuscular exercise training and cognitive behavioral therapy
16123941|NCT01981096|Behavioral|Cognitive Behavioral Therapy|Therapy focused on training in behavioral pain coping skills
16123942|NCT01981083|Dietary Supplement|Egg albumin-based protein supplement|
16123943|NCT01981083|Dietary Supplement|Renal-specific oral supplement|
16123944|NCT01981070|Behavioral|Mindfulness Intervention for Parents|See Study Arms
16123945|NCT01981070|Behavioral|Support and Information for Parents|See Study Arms
16123946|NCT01981057|Other|Numeta|parenteral receipt prescribed with Numeta
16123947|NCT01981057|Other|Individual|parenteral receipt prescribed individually
16123948|NCT01981044|Device|Silk surgical mesh|A CE Marked, 510(k) cleared, knitted, multi-filament, bioengineered, silk mesh indicated for use as a transitory scaffold for soft tissue support and repair
16123949|NCT01981031|Drug|BioChaperone® Combo|Single dose of 0.8U/kg body weight injected subcutaneously (under the skin)
16123950|NCT01981031|Drug|Humalog® Mix25|Single dose of 0.8U/kg body weight injected subcutaneously (under the skin)
16123951|NCT01981018|Other|Imagery-focused Cognitive Therapy (ImCT - psychotherapy based on CBT principles)|"ImCT Therapy is carried out by a team of 2 co-therapists and comprises of:
~Mapping: Therapists and patient collaboratively map out difficulties and pinpoint a treatment focus, with regards to imagery symptoms and anxiety co-morbidity that impact on bipolar mood instability. This leads to an individualised formulation of the patient's current problem.
~Target: Follows the rationale, timing and objectives identified collaboratively in Mapping. It is structured around imagery-based techniques, such as imagery rescripting, which are used to address problematic imagery, to promote management of mood and boost self-care. This results into the acquisition of imagery-based mood- and anxiety-regulating strategies to be integrated into the patient's already existing coping strategies.
~Consolidation: Consist of fine tuning the strategies devised during Target based on experience gained after testing them out in real life situations and includes a video blue print."
16123952|NCT01981005|Drug|RO5424802|Single oral doses followed by IV or oral administration of a 14C-labeled tracer
16123953|NCT01980992|Drug|Wheat OIT|Vital Wheat Gluten dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses.
16123954|NCT01980979|Drug|Remodulin|Subcutaneous (SQ) remodulin will be initiated at 1.25 ng/kg/min, and increased by 2-6 ng/kg/min weekly to a target dose of 40 ng/kg/min. If the initial infusion rate cannot be tolerated it will be reduced to 0.625 ng/kg/min. If subjects cannot tolerate the SQ therapy, we will attempt to switch to IV therapy.
16123955|NCT01980966|Drug|MHAA549A|IV dose
16123956|NCT01980966|Drug|Placebo|IV dose
16123957|NCT01980966|Drug|oseltamivir [Tamiflu]|Orally b.i.d, 5 days
16123958|NCT01980953|Drug|GDC-0032 Phase III Tablet|Participants will receive 2 mg or 3 mg Phase III tablet after 10 hour fasting from food.
16123959|NCT01980953|Drug|GDC-0032 Tablet|Participants will receive 3 mg Tablet A or Tablet B formulation after 10 hour fasting from food.
16123960|NCT01980953|Drug|GDC-0032 Capsule|Participants will receive 3 mg GDC-0032 capsule formulation after 10 hour fasting from food.
16123961|NCT01980940|Drug|Etoricoxib 75 mg 4% DMSO Gel|Etoricoxib 75 mg 4% DMSO gel applied topically.
16123962|NCT01980940|Drug|Etoricoxib 75 mg 4% PG Gel|Etoricoxib 75 4% PG gel applied topically.
16123963|NCT01980940|Drug|Etoricoxib 150 mg 4% DMSO Gel|Etoricoxib 150 mg 4% DMSO gel applied topically.
16123964|NCT01980940|Drug|Etoricoxib 150 mg 4% PG Gel|Etoricoxib 150 mg 4% PG gel applied topically.
16123965|NCT01980940|Drug|Etoricoxib 163 mg 4% DMSO gel|Etoricoxib 163 mg 4% DMSO gel applied topically
16123966|NCT01980940|Drug|Placebo|Placebo gel applied topically.
16123967|NCT01980940|Drug|Etoricoxib 50 mg 4% DMSO|Etoricoxib 50 mg 4% DMSO gel applied topically.
16123968|NCT01980940|Drug|Matching Placebo to Etoricoxib 50 mg 4% DMSO Gel|Matching Placebo to Etoricoxib 50 mg 4% DMSO gel applied topically.
16123969|NCT01980927|Procedure|NUCCA atlas correction|"A chiropractic procedure involving correcting a misalignment of the atlas or top vertebra in the spine."
16123970|NCT01980914|Device|iPro2 glucose sensor attachment|At the same time the glucose sensor is started, a trained research nurse will connect the patient to an Icentia CardioSTAT, a continuous ambulatory ECG cardiac monitor.
16123971|NCT01980901|Device|Ovation™/Ovation Prime™ Abdominal Stent Graft System|Single occurence permanent implant of AAA device.
16123972|NCT01980888|Drug|Idelalisib|150 mg tablet administered orally twice daily
16123973|NCT01980888|Drug|Bendamustine|Administered intravenously at a starting dose of 90 mg/m^2 for up to 6 cycles. Dosing will be based on mg/m^2 of body surface area.
16123974|NCT01980888|Drug|Rituximab|Single-use vials administered intravenously weekly starting at 375 mg/m^2 on Day 1 (Week 0) and 500 mg/m^2 thereafter for a total of 6 infusions
16123975|NCT01980888|Drug|Placebo|Placebo to match idelalisib administered orally twice daily
16123976|NCT01980875|Drug|Idelalisib|150 mg tablet administered orally twice daily
16123977|NCT01980875|Drug|Chlorambucil|2 mg tablets administered at a dose of 0.5 mg/kg orally every other week for a total of 12 doses
16123978|NCT01980875|Drug|Obinutuzumab|1000 mg/40 mL single-use vials administered intravenously for a total of 8 doses over 21 weeks
16123979|NCT01980849|Drug|Nadroparin, long term|
16123980|NCT01980849|Drug|Nadroparin: short-term|
16123981|NCT01980836|Biological|Seasonal influenza vaccine|
16123982|NCT01980823|Drug|Metformin|"Metformin is an oral diabetes medicine that helps control blood sugar levels.
~Dosage/Frequency: 1500 mg per day: divided 500 mg in the morning and 1000 mg in the evening
~Metformin is for people with type 2 diabetes. Metformin is sometimes used in combination with insulin or other medications, but it is not for treating type 1 diabetes."
16123983|NCT01980823|Drug|Atorvastatin|"Atorvastatin is in a group of drugs called statins. Atorvastatin reduces levels of bad cholesterol (low-density lipoprotein, or LDL) and triglycerides in the blood while increasing levels of good cholesterol (high-density lipoprotein, or HDL).
~Dosage/Frequency: 80 mg once a day at bedtime
~Atorvastatin is used to treat high cholesterol, and to lower the risk of stroke, heart attack, or other heart complications in people with type 2 diabetes, coronary heart disease, or other risk factors."
16124573|NCT01975701|Drug|BGJ398|Capsule for oral use.
16123984|NCT01980823|Procedure|Breast surgery|(Non-experimental) Female subjects with histologically-confirmed operable invasive breast cancer or DCIS will undergo core needle biopsy with a plan of surgical excision.
16123985|NCT01980810|Drug|albumin-bounded paclitaxel|200mg iv d1, repeat every 2 weeks,until disease progression,or up to 9 cycles
16123986|NCT01980810|Drug|S-1|40mg/m2 po, bid,d1-10,repeated every 2 weeks until disease progression
16123989|NCT01980758|Procedure|Laparoscopic Gastric Plication|The study will examine the effects of a type of weight loss surgery on obese adolescents age 14-19. ) The study protocol includes pre-treatment assessments followed by a 2-month education and lifestyle modification treatment program. Following surgery, comprehensive follow-up care will be provided over a 3 year period.
16123990|NCT01980745|Drug|Chloroquine diphosphate 250mg|Sugar pill (placebo) one pill per day for 1110 days Chloroquine diphosphate 250mg per day for 1110 days
16123991|NCT01980745|Drug|Placebo|
16123992|NCT01980732|Drug|68Ga-DOTA TATE|Patients with somatostatin receptor positive tumors will be evaluated with 68Ga-DOTA TATE PET/CT in addition to conventional imaging.
16123993|NCT01980706|Drug|Baclofen|Baclofen is a GABA-B agonist
16123994|NCT01980706|Drug|Placebo|Pill containing no pharmacologically active substance.
16123995|NCT01980693|Device|SonicBone ultrasound|The device measure BA using ultrasound technology by measurement of speed of sound in three different sites : wrist bones, Phalanx III, Metacarpal bones.The device sends a short US pulse and measures the distance between a transmitter probe and a receiver probe, located at the bone measured area.The US probe converts electrical pulse to US pulse and US wave via tested bone arrives from transmitter to Receiver. Simultaneously with US pulse, controller start timer to calculate time between US pulse and the moment that US wave arrives to receiver. The accepted US signal of selected probe via amplifiers arrives to comparators that read timer value. The microcontroller calculates SOS using distance between probes and US time of flight.
16123996|NCT01980680|Drug|hCG|
16123997|NCT01980680|Drug|Progesterone and Estradiol|
16123998|NCT01980667|Drug|lurbinectedin (PM01183)|lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials.
16123999|NCT01980667|Drug|Cisplatin|vials containing 1 mg/ml concentrate for solution for infusion
16124000|NCT01980654|Drug|Ibrutinib|All subjects will receive 560 mg of Ibrutinib orally.
16124001|NCT01980654|Drug|rituximab|All subjects will receive rituximab 375 mg/m2 intravenously
16124002|NCT01980641|Behavioral|Educational intervention|All subjects received an educational intervention consist in an educational advice provides by the therapist to improve the adherence of the treatment.
16124003|NCT01980641|Device|Smartphone-based application|Smartphone-based application group (SG) sample will have a reminder. The app will provide the advice previously given by the therapist in the participants' homes.
16124004|NCT01980628|Drug|ibrutinib|
16124005|NCT01980615|Drug|Inhaled BGF (PT010) Dose 1|
16124006|NCT01980615|Drug|Inhaled BGF (PT010) Dose 2|
16124007|NCT01980615|Drug|Inhaled BGF (PT010) Dose 3|
16124008|NCT01980615|Drug|Inhaled GFF (PT003)|
16124009|NCT01980615|Drug|Inhaled Symbicort Dose 1|
16124010|NCT01980615|Drug|Inhaled Symbicort Dose 2|
16124011|NCT01980602|Procedure|Supervised Exercise program|
16124012|NCT01980589|Drug|Carfilzomib|Carfilzomib administered as a 30-minute intravenous (IV) infusion on Days 1, 2, 8, 9, 15, and 16 of each 28-day cycle. On Days 1 and 2 of Cycle 1, all participants received carfilzomib at 20 mg/m².
16124013|NCT01980589|Drug|Cyclophosphamide|Cyclophosphamide administered orally (PO) at the dose of 300 mg/m² on Days 1, 8, and 15 of each 28-day cycle.
16124014|NCT01980589|Drug|Dexamethasone|Dexamethasone administered PO or IV at 40 mg on Days 1, 8, 15, and 22 of each 28-day cycle.
16124015|NCT01980563|Procedure|ultrasound|
16124016|NCT01980563|Procedure|combined monitoring|
16124017|NCT01980550|Drug|sublingual nicotine|The nicotine sublingual tablet is Smokers were recommended to use one or two tablets per hour, up to a maximum of 20 tablets per day. Subjects were advised to use the full treatment dose for 4 weeks. After this time-point, treatment could be tapered off up to the 8-week visit. During the next 4-week follow-up phase, no further medication was dispensed. Staff, who dispensed medications, were not involved in treating the subjects. During each patient visit, the importance of adequate dosing with study medication was emphasized. The medication was free of charge. In addition, all participants received six sessions of standardized behavioral group counseling focusing on self-monitoring and behavioral modification approaches.
16124018|NCT01980537|Procedure|Magnetic wire navigation|
16124019|NCT01980537|Procedure|Conventional wire navigation|
16124020|NCT01980524|Drug|acipimox|
16124021|NCT01980524|Drug|Placebo Oral Capsule|
16124022|NCT01980498|Drug|Fentanyl pectin nasal spray (FPNS)|The first dose of FPNS will be 100 mcg dose. It will be increased until 800 mcg dose.
16124023|NCT01980498|Drug|Physician choice-Usual care (PC-UC)|"The PC-UC will be started at a dose according to the physician choice. If this dose of PC-UC is effective on pain control, at the following meal the patient will take the same dose of PC-UC.
~If the dose of PC-UC results non effective on pain control, at the following meal the patient will take an increased dose of the same PC-UC drug or change the PC-UC drug, according to the physician choice."
16124060|NCT01980147|Behavioral|maCBT|Multimodal Antecedent-focussed Cognitive-behavioural Training (maCBT) is an individual manualized psychological intervention. It follows an integrated model focussed on normalisation of the unusual experiences, their re-appraisal, exploring helpfulness of current coping, and developing a repertoire of strategies to decrease the impact of these experiences on the young person's life. The maCBT follows a manual describing obligatory and optional therapeutic elements, proposed list of modules, outline of a therapeutic session, and the integrated cognitive model. The intervention will be delivered in 8 to 16 one-hour sessions in an individual format. Sessions will be initially weekly, and then spaced out to once every two weeks in the latter stages of the intervention.
16124061|NCT01980121|Device|Ultrasound|Two-dimensional portable ultrasound unit with a low frequency (2-5 MHz) curved array transducer
16124062|NCT01980108|Other|water|water
16124024|NCT01980485|Behavioral|Lung Age feedback and exhaled carbon monoxide|"In the intervention group, if the lung age is equal to or less than the individual's chronological age, he or she will be briefly informed that the test result was normal and that it is important to avoid potential future lung problems by stopping smoking. For those in the intervention group with a normal FEV-1, the intervention will focus on their exhaled carbon-monoxide.
~If their lung age is greater than their chronological age, they will be given their lung age in years, and provided with a graph describing the possible decline in lung age if they continued to smoke and a full explanation.
~Those in the Intervention Group will have their exhaled carbon-monoxide (CO) result explained in more detail. Non-smokers typically have an exhaled carbon-monoxide level of 0-4 parts per million, whereas smokers typically have a CO level of 8-50 ppm. CO levels return to normal within a few days of stopping smoking. Participants are provided with a full explanation."
16124025|NCT01980485|Behavioral|No Lung Age Feedback|Those allocated to the control group will simply be informed of their scores on the spirometry.
16124026|NCT01980472|Biological|bevacizumab, carboplatin and paclitaxel|4-6 initial cycles of bevacizumab, carboplatin and paclitaxel bevacizumab until progression or toxicity
16124027|NCT01980459|Dietary Supplement|magnesium lactate|Patient will be given 4 tablets a day of study supplement (Magnesium Lactate) for 3 months. Magnesium cellular and serum levels will be compared prior and post intervention.
16124028|NCT01980446|Procedure|Auditory-evoked potentials|cortical auditory-evoked potentials are performed to all included patients at inclusion, at day 5 to day 10, day without sedation (up to 1 year), day of awakening
16124029|NCT01980433|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|Inhibitory 1 Hz rTMS, delivered to left somatosensory cortex during rest. Intervention is delivered during 20 minutes in one single session.
16124030|NCT01980433|Other|pre and post-rTMS electroencephalogram|to verify the absence of infraclinical seizures
16124031|NCT01980433|Other|WCRS|Writer's cramp rating scale
16124032|NCT01980433|Other|handwriting scale DPRE|handwriting in development and being evaluated by the NRC Wilson
16124033|NCT01980433|Other|visual analog scale of discomfort writing and parameters collected on touchpad|
16124034|NCT01980420|Procedure|Laparoscopic sleeve gastrectomy|Conventional laparoscopic sleeve gastrectomy using EndoFLIP® probe to provide measures on the distensibility of gastro-esophageal junction (GEJ) and gastric tube.
16124035|NCT01980407|Drug|S-1, leucovorin, oxaliplatin|S-1 (20mg), capsule, 40-60mg, bid, p.o., day1-14； Leucovorin (15 mg), tablet, 30mg,Bid, p.o., day1-14; Oxaliplatin (50 mg), injection 85mg/m2, day1.
16124036|NCT01980394|Procedure|Esophageal Stump Washout|a washout of the closed esophageal stump with Ringer-solution (10 times 30ml) is performed by means of a transorally inserted 24F-Foley catheter. The first, fifth and tenth portion of the lavage fluid are collected and sent to cytological examination
16124037|NCT01980381|Other|Tree Theme Method ® (TTM)|The TTM method is based on creative activities and occupational life story telling, implies that the paints trees representing different life periods, looking back and forward, as well as the present.
16124038|NCT01980368|Other|Educational Intervention|Receive readings and attend book club
16124039|NCT01980368|Behavioral|Exercise Intervention|Receive Tai Chi Easy class, DVD, and exercise manual
16124040|NCT01980368|Other|Questionnaire Administration|Ancillary studies
16124041|NCT01980355|Drug|Tranexamic Acid|
16124042|NCT01980355|Other|Placebo|
16124043|NCT01980342|Drug|Efavirenz|Healthy women who are using Nexplanon will be asked to take a 2-week course of reduced-dose efavirenz (400 mg daily).
16124044|NCT01980329|Drug|Maraviroc|
16124045|NCT01980316|Drug|Argatroban|Argatroban in patients undergoing load 250μg/kg, followed by 15μg/kg/min continuous intravenous infusion.5 days after surgery, take 10mg intravenous infusion of speed 2/day
16124046|NCT01980316|Drug|non-argatroban treated group|Patients in control group will receive Unfractionated heparin treatment
16124047|NCT01980303|Drug|Esketamine|Fourteen percent esketamine solution (14 mg of esketamine per 100 microliter) will be administered intranasally by nasal spray pump.
16124048|NCT01980277|Drug|LY2780301 + paclitaxel|Continuous daily PO LY2780301 (400 mg, 500 mg or 300 mg) QD + weekly paclitaxel (70 or 80 mg/m²/week) for 21 days cycle until progression or toxicity
16124049|NCT01980264|Device|Harmonic Generation Microscopy|Harmonic Generation Microscopy is a nonlinear optical microscopy.
16124050|NCT01980238|Device|cannula ileostomy|
16124051|NCT01980238|Device|loop ileostomy|
16124052|NCT01980238|Device|LAR|
16124053|NCT01980225|Procedure|Collapse|inducing collapse (= artificial shrinkage) by applying 1 or 2 laser pulses between trophectoderm cells of the blastocyst to be vitrified
16124054|NCT01980199|Drug|Fexinidazole|"600 mg tablets given orally, after the main daily meal
~at the daily dose of 1800 mg (3 tablets) once a day for 4 days
~continued by 1200mg (2 tablets)once a day for 6 days"
16124055|NCT01980186|Device|TUS transcranial 2D ultrasound|
16124056|NCT01980173|Procedure|Routine care|Following diagnosis with post-partum hemorrhage, an initial 30 minute phase corresponding to current recommendations, an injection of sulprostone, a demonstrated inefficacy of sulprostone 20 minutes after the injection and finally randomization, patients in this arm of the study will continue to have routine care.
16124057|NCT01980173|Device|Bakri balloon|Following diagnosis with post-partum hemorrhage, an initial 30 minute phase corresponding to current recommendations, an injection of sulprostone, a demonstrated inefficacy of sulprostone 20 minutes after the injection and finally randomization, patients in this arm will be treated with the immediate placement of a Bakri balloon, followed by routine care if necessary.
16124058|NCT01980160|Device|Activated Nometex Device|Nometex Device that is activated so will be sending electrical pulses to the median nerve which will travel through afferent nerve fibers to the emetic centers of the brain. It is in these areas that the neurotransmitters modulate signals going to the stomach via the Vagus nerve. These electrical signals normalize the stomach rhythms, thereby alleviating nausea and vomiting.
16124059|NCT01980160|Device|Unactivated Nometex Device|
16124063|NCT01980095|Drug|RHB-105|"The intended dose is RHB-105 (12.5 mg rifabutin, 250 mg amoxicillin, and 10 mg omeprazole capsules) 4 capsules every eight hours, equivalent to a total daily dose of:
~Rifabutin 150 mg
~Amoxicillin 3000 mg
~Omeprazole 120 mg
~Subjects will take study drug every 8 hours with food for 14 consecutive days."
16124064|NCT01980095|Drug|Placebo|Subjects will take 4 placebo capsules every 8 hours with food for 14 days.
16124067|NCT01980069|Drug|Sugammadex|In sugammadex group, sugammadex (Bridion, Merck Shart and Dohme (MSD), Oss, the Netherlands) will be administered intravenously in different doses according to the degree of muscle relaxation. Sugammadex 8 mg/kg will be administered if there is no response on post-tetanic count (PTC) stimulus. Sugammadex 4 mg/kg will be administered if PTC is more than 1 or 2. Sugammadex 2 mg/kg will be administered if T2 response appears on train-of-four (TOF) stimulus.
16124068|NCT01980069|Drug|Neostigmine|In neostigmine group, neostigmine 50 ㎍/kg will be administered intravenously with glycopyrrolate 10 ㎍/kg when the T2 response appears on TOF stimuli.
16124069|NCT01980056|Drug|Vosaroxin|Dose level 1: Vosaroxin 50 mg^m2 IV on Days 1 and 4 of 28 day cycle Dose level 2: Vosaroxin 72 mg^m2 IV on Days 1 and 4 of 28 day cycle Dose level 3: Vosaroxin 50 mg^m2 IV on Days 1, 4, 8 and 11 of 28 day cycle
16124070|NCT01980043|Procedure|endoluminal rectal prolapse repair under sedation|endoluminal rectal prolapse repair under sedation
16124071|NCT01980030|Drug|Romiplostim|
16124072|NCT01980017|Behavioral|Ottawa Model for Smoking Cessation|
16124073|NCT01980004|Dietary Supplement|Potassium Citrate Supplementation|20 mEq taken twice daily
16124074|NCT01980004|Other|Dietary Education|Dietary counseling will include both a verbal discussion in the clinic regarding increased fluid intake, a moderate calcium rich diet and lemonade therapy as well as receiving a written handout on these topics.
16124075|NCT01979991|Procedure|CT Imaging and Reconstruction|"Patients will be consented for their permission to save and use the sinogram from their CT chest/lung scan. The sinogram will be de-identified and sent to an archive system for storage.
~Later it will be exported to a computer for processing using MBIR (model based image reconstruction). The newly processed images will then be read by blinded readers. The quality of the images will be reviewed to determine if they are as readable and accurate as CT images created with the software that is currently being used."
16124076|NCT01979978|Other|Healthy Buddies Curriculum|"Each week, intermediate students will receive a 45-minute healthy-living lesson plan from their classroom teacher. Later that week, intermediate students will serve as peer mentors (Buddies), teaching a 30-minute lesson to their younger students. The Physical activity (i.e.Go Move!) component of the lesson plans includes 30-minutes of structured aerobic fitness sessions, called fitness loops, with the student pairs twice weekly. The dietary (Go Fuel!) component includes lessons about distinguishing nutritious and from unhealthy (nutrient poor-energy rich) foods and beverages. The body image (Go Feel Good!) component, the students are taught to value classmates based on individual traits rather than peer influence."
16124077|NCT01979965|Drug|Ranolazine (Active drug)|Ranolazine therapy for three months
16124078|NCT01979965|Drug|Placebo|Placebo therapy for three months
16124079|NCT01979952|Drug|Matching Placebo|twice daily dosing
16124080|NCT01979952|Drug|Nintedanib|gelating capsule
16124081|NCT01979939|Drug|DCV/ASV/BMS-791325|
16124082|NCT01979926|Drug|Combination of Broussonetia spp and Lonicera spp|600 mg/ day or 1200 mg/ day for 7 days
16124083|NCT01979913|Drug|Saflutan® 15 microgram/ml Augentropfen im Einzeldosisbehältnis|
16124084|NCT01979900|Drug|Vaccae|One vial of Vaccae diluted with 1.0ml sterile water for injection, take deep coxal muscle injection after shaking well, once every 2 weeks, 6 times totally.
16124085|NCT01979900|Drug|placebo|One vial of placebo diluted with 1.0ml sterile water for injection, take deep coxal muscle injection after shaking well，once every 2 weeks, 6 times totally.
16124086|NCT01979887|Procedure|Meibum Expression|Meibum expression as per protocol. No investigational drug is administered in this study.
16124087|NCT01979874|Dietary Supplement|Pro-Omega|Pro-Omega (Nordic Naturals, Watsonville, CA, USA). Each ProOmega capsule contains 325mg of EPA and 225mg of DHA. 4.4gm/day x 3 months
16124088|NCT01979874|Other|ProOmega Placebo|Placebo Comparator: soybean (Nordic Naturals, Watsonville, CA, USA); 4.4gm/day x 3 months
16124089|NCT01979861|Device|AEGEA Vapor System(TM)|vapor endometrial ablation
16124090|NCT01979835|Device|GyneFix Viz|insertion of GyneFix Viz and measurment of the SA distance
16124091|NCT01979822|Other|PH patients with LenusPro pump|Observation/measurement of complications in PH patients with LenusPro pump in the frist six month after implantation of pump
16124092|NCT01979809|Behavioral|MENU GenY|Participants will assess eligibility, complete consent and baseline survey to enroll online, then be randomized to one of 3 arms: Control Arm 1 - a non-tailored intervention with no age targeting; Arm 2 -age targeted, tailored website set to appeal to young adults and offer a varety of support using muli-media to improve dietary intake of fruit, vegetables and whole grains, and decrease sweet drinks. Arm 3 utilizes the same intervention as Arm 2, and has support via email from eCoaches who use a Motivational Interview approach to support to help change dietary patterns. All arms are active for 4 months with occasionalemail contact throughout the following 8 mo. Follow-up surveys occur at 3 mo, 6 mo, and primary outcome at 12 months.
16124093|NCT01979796|Device|Ecig 24 mg nicotine|Cigalike
16124094|NCT01979796|Device|Ecig 0 mg nicotine|Cigalike
16124095|NCT01979796|Device|Nicotine free inhalator|Plastic CIG a Like
16124096|NCT01979757|Other|Puregraft|
16124097|NCT01979757|Other|Centrifugation|
16124098|NCT01979744|Procedure|IVUS guided percutaneous coronary angioplasty with Resolute integrity stent insertion|Resolute integrity stent implantation (diameter from 2.5mm to 3.5mm, length 30, 34, 38mm) The size and number of stents and post-dilation will be determined on physician's discrete within the range allowed in this study protocol. All procedure will be performed according to current standard technique. IVUS will be used to assess the anatomic characteristics of lesion and determine appropriate stent size and length. Additional stent implantation or post dilation will be allowed according to attending physician's discrete based on IVUS results.
16124099|NCT01979744|Device|Angiography guided percutaneous coronary angioplasty with Resolute integrity stent insertion|Resolute integrity stent implantation (diameter from 2.5mm to 3.5mm, length 30, 34, 38mm) The size and number of stents and post-dilation will be determined on physician's discrete within the range allowed in this study protocol. All procedure will be performed according to current standard technique. Additional stent implantation or post dilation will be allowed according to attending physician's discrete. IVUS will be not used in this arm.
16124152|NCT01979406|Biological|Ad4-PA-1|Ad4-PA will be given at 10^9, 10^10 and 10^11 on Day, followed by an oral placebo on Day 15 and an AVA boost on Day 29
16124638|NCT01975233|Device|WEB Aneurysm Embolization System|WEB Aneurysm Embolization System
16124100|NCT01979744|Device|Angiography guided percutaneous coronary angioplasty with Promus element stent implantation|Promus element stent implantation (diameter from 2.5mm to 3.5mm, length 28, 32, 36mm) The size and number of stents and post-dilation will be determined on physician's discrete within the range allowed in this study protocol. All procedure will be performed according to current standard technique. Additional stent implantation or post dilation will be allowed according to attending physician's discrete. IVUS will be not used in this arm.
16124101|NCT01979744|Procedure|Angiography guided percutaneous coronary angioplasty with Promus element stent implantation|Promus element stent implantation (diameter from 2.5mm to 3.5mm, length 28, 32, 36mm) The size and number of stents and post-dilation will be determined on physician's discrete within the range allowed in this study protocol. All procedure will be performed according to current standard technique. IVUS will be used to assess the anatomic characteristics of lesion and determine appropriate stent size and length. Additional stent implantation or post dilation will be allowed according to attending physician's discrete based on IVUS results.
16124102|NCT01979731|Other|Job rotation|The intervention group will perform rotation function, switching between tasks with low, moderate and high ergonomic risk and different requests for ergonomic body region added to ergonomic guidelines.
16124103|NCT01979731|Other|Guidelines ergonomics|Orientation about manual material handling, posture, furniture, rest break and others in general.
16124104|NCT01979718|Device|Mirrored Virtual reality|Patients are required to look at the images of both lower extremities ranged from the perineal area to the foot. Virtual reality system records in real-time method both lower extremities. Following the validity assessement mirrored image of the surgeried lower extremity is re-formed using the virtusal reality system flipping the image of lower extremity not-surgeried and being calibration for the symmetricity.
16124105|NCT01979692|Procedure|confocal laser microscopy CLM at trans thoracic needle biopsy TTNB|
16124106|NCT01979692|Device|CT guided trans thoracic needle biopsy|
16124107|NCT01979679|Drug|Lurasidone 80 mg|
16124108|NCT01979679|Drug|Lurasidone 120 mg|
16124109|NCT01979679|Drug|Lurasidone 160 mg|
16124110|NCT01979666|Drug|nitrate patch|patients in the study group will get a nitrate patch
16124111|NCT01979666|Drug|placebo patch|control group patients will get a placebo patch
16124112|NCT01979666|Device|MRI scan|MRI scan after 6 weeks of treatment
16124113|NCT01979653|Drug|dexmedetomidine alone or dexmedetomidine + midazolam|
16124114|NCT01979640|Procedure|39 Fr double lumen tube group|additional bronchial cuff volume is decided according to up-and-down biased coin design sequential method, by incremental volume of 0.1 ml
16124115|NCT01979640|Procedure|37 Fr double lumen tube group|additional bronchial cuff volume is decided according to up-and-down biased coin design sequential method, by incremental volume of 0.1 ml
16124116|NCT01979640|Procedure|35 Fr double lumen tube group|additional bronchial cuff volume is decided according to up-and-down biased coin design sequential method, by incremental volume of 0.1 ml
16124117|NCT01979627|Procedure|transulnar approach interventional procedure|
16124118|NCT01979627|Procedure|transradial approach interventional procedure|
16124119|NCT01979614|Drug|Serelaxin|Serelaxin solution diluted in 5% glucose volume/volume (v/v) solution
16124120|NCT01979614|Other|Placebo|5% v/v glucose solution
16124121|NCT01979601|Drug|LGT209|150 mg lyophilized powder in glass vial
16124122|NCT01979601|Drug|Placebo|Placebo comparator
16124123|NCT01979588|Other|What's Going Around tool|Provider has access to the What's Going Around tool
16124124|NCT01979588|Other|Control|Provider does not have access to the What's Going Around tool but received information regarding the tool prior to study initiation
16124125|NCT01979536|Drug|Brentuximab Vedotin|Given IV
16124126|NCT01979536|Drug|Crizotinib|Given PO
16124127|NCT01979536|Drug|Cyclophosphamide|Given IV
16124128|NCT01979536|Drug|Cytarabine|Given IT and IV
16124129|NCT01979536|Drug|Dexamethasone|Given PO or IV
16124130|NCT01979536|Drug|Doxorubicin Hydrochloride|Given IV
16124131|NCT01979536|Drug|Etoposide|Given IV
16124132|NCT01979536|Drug|Ifosfamide|Given IV
16124133|NCT01979536|Drug|Methotrexate|Given IT and IV
16124134|NCT01979523|Other|Laboratory Biomarker Analysis|Correlative studies
16124135|NCT01979523|Other|Pharmacological Study|Correlative studies
16124136|NCT01979523|Drug|Trametinib|Given PO
16124137|NCT01979523|Drug|Uprosertib|Given PO
16124138|NCT01979510|Drug|MK-0663B|MK-0663B once daily for 8 days.
16124139|NCT01979510|Drug|DOLOCAM PLUS®|DOLOCAM PLUS® once daily for 8 days.
16124140|NCT01979510|Drug|Acetaminophen 500 mg|Acetaminophen 500 mg up to 4 times daily for up to 8 days as required for uncontrolled breakthrough pain.
16124141|NCT01979497|Procedure|Suture with Adhesive Stripping|
16124142|NCT01979497|Procedure|Suture without Adhesive Stripping|
16124143|NCT01979484|Drug|PPI-668 capsule|
16124144|NCT01979484|Drug|PPI-668 tablet|
16124145|NCT01979471|Other|Advanced Care|"The pharmacist will complete a Comprehensive Annual Care Plan (CACP) or Standard Medication Management Assessment (SMMA), which will include:
~Patient assessment
~Laboratory assessment of HbA1c and lipids
~Individual assessment of CVD risk and education about this risk
~Calculation of cardiovascular risk will be facilitated by an online tool
~Discussion of CVD risk with the patient using the interactive online tool which explains his/her individual cardiovascular risk and targets for intervention and providing the patient with education on cardiovascular risk factors and healthy lifestyle options
~Treatment recommendations, Prescription adaptation(s), and/or prescribe where necessary to meet lipid, blood pressure and glycemic control targets and smoking cessation.
~Regular communication with the patient's family physician after each contact with the patient
~Regular follow-up with all patients a minimum of every 3-4 weeks for 3 months."
16124146|NCT01979458|Device|PSE|
16124147|NCT01979445|Drug|Cangrelor|Cangrelor intravenously (IV) administered as a 30 microgram (µg)/kilogram (kg) bolus, followed by 4 µg/kg/min infusion for 2 hrs on Day 1.
16124148|NCT01979445|Drug|Clopidogrel|Clopidogrel 600 mg single oral dose
16124149|NCT01979445|Drug|Prasugrel|Prasugrel 60 mg single oral dose
16124150|NCT01979432|Other|Cardiovascular evaluation|
16124151|NCT01979406|Biological|AVA|Anthrax Vaccine Adsorbed (0.5 mL) as the placebo control on Days 1, 15 and 29
16124153|NCT01979406|Biological|Ad4-PA-GPI-1|"Given at 10^9, 10^10 and 10^11 viral particles
~Ad4 PA-GPI at Day 1 + oral placebo on Day 29 + AVA boost at Day 15"
16124154|NCT01979393|Drug|Cabozantinib|
16124155|NCT01979393|Drug|Placebo|
16124156|NCT01979380|Drug|KD101|200mg (1casule), 600mg (3 capsule), 1000mg (5 capsule), 1400mg (7 capsule) PO, once in the morning
16124157|NCT01979380|Drug|placebo|PO, once in the morning
16124158|NCT01979367|Device|Anodyne|Subjects will be treated with MIRE therapy using the Anodyne® device within 72 hours of previous treatments, and in accordance with the Anodyne® package insert indications for use 30 to 45 minutes professional units on power setting of 8,. In addition, patients will undergo TENS therapy with the use of either the Avazzia® Pro Sport or TENS 3000 (for no less than 30 mins, both on label) in accordance with the indications for use of each TENS device, for a minimum of 15 minutes at the subjective site for pain and each vertebrae nerve base, when impairment is confirmed with the objective Small Pain Fiber (SPF) Nerve Conduction Study (NCS) test performed.
16124159|NCT01979354|Drug|Spinal morphine|0.15 mg spinal morphine
16124160|NCT01979341|Procedure|final oocyte maturation trigger|when ≥3 follicles reach 17mm patients will be randomized to receive one of two types of trigger for final oocyte maturation; dual trigger: GnRH agonist plus hCG (both full doses) hCG only: full dose of hCG only
16124161|NCT01979328|Device|geko|
16124162|NCT01979328|Device|Plaster cast|
16124163|NCT01979302|Other|Depression CAREPATH|Nurses receive training and agency support in depression assessment and depression care management
16124164|NCT01979302|Other|Usual Care|Nurses receive training in depression assessment and review of usual care procedures.
16124165|NCT01979289|Other|computerized cognitive remediation|
16124166|NCT01979289|Other|computerized cognitive remediation:Control|
16124167|NCT01979276|Drug|Romidepsin|Romidepsin intravenously on days 1 and 15 of a 28-day cycle
16124168|NCT01979276|Drug|pomalidomide|Pomalidomide 4mg daily by mouth on days 1-21 of a 28-day cycle
16124169|NCT01979276|Drug|Dexamethasone|Dexamethasone 40mg by mouth on days 1, 8, 15 and 22 of a 28-day cycle
16124170|NCT01979263|Other|Attention Bias Modification Computer Task|Computer task aimed at actively modifying attention bias
16124171|NCT01979263|Other|Placebo Computer Task|Computer task that does not actively modify attention bias
16124172|NCT01979250|Procedure|DSAEK surgery|"Corneal endothelial transplantation by Descemet's stripping automated endothelial keratoplasty (DSAEK)."
16124173|NCT01979237|Procedure|SPASO method and FARES method|SPASO method and FARES method as shoulder dislocation reduction methods
16124174|NCT01979224|Other|Educational intervention for parents|educational sessions once a week two hours for a month and later educational reinforcement and monitoring asthma control monthly for nine months
16124175|NCT01979211|Drug|Cetuximab|400 mg/m2 IV over 120 minutes week 1; 250 mg/m2 IV over 60 minutes weekly weeks 2-7
16124176|NCT01979211|Radiation|Radiation Therapy|Radiation Therapy 60-66 Gy in 2 Gy fractions starting week 2 of Cetuximab
16124177|NCT01979185|Drug|Simvastatin|
16124178|NCT01979185|Drug|SSP-004184SS|
16124179|NCT01979159|Behavioral|Combined Aphasia and Apraxia of Speech Treatment (CAAST)|Therapy is delivered in a face-to-face format. The therapist uses picture stimuli, verbal modeling, feedback, reinforcement, forward-chaining to increase verbal production. For speech errors that occur, the therapist uses modeling, feedback, reinforcement, simultaneous production, articulatory instruction, and repeated practice to improve articulation.
16124180|NCT01979146|Other|Provider Unrelieved Symptom Alert|The Provider Unrelieved Symptom Alert intervention sent an automatic symptom report to oncology providers (both physician and nurse) when the patient reported symptoms at a moderate to severe level (4-10 on a 0-10 scale). The oncology providers used their clinical judgement in terms of what they did with the information received. There was no prescribed response as part of the intervention.
16124181|NCT01979133|Drug|Icariin|Participants will receive 20% icariin (100 mg/day) in a commercially available over-the-counter Horny Goat Weed supplement. A dose titration from 100 mg/day to 200 mg/day will be allowed at week 3 participants with less than a 30% reduction in HAMD and/or still using cocaine or alcohol or have a positive urine drug screen. An additional dose titration to 300 mg/day will be allowed at week 6 for participants with less than a 50% reduction in HAMD scores and/or still using cocaine or alcohol or have a positive urine drug screen.
16124182|NCT01979107|Behavioral|Proactive action by the general practitioner|"Individuals allocated to the intervention group will receive a personal invitation to an appointed health check from their general practitioner. Three days before the appointment participants will be reminded by phone about the appointment.
~At the health check a follow-up consultation will be scheduled. At the follow-up consultation the results of the health check will be reviewed. All participants with abnormal screens at the health check will, depending of the severity, either receive the offer of a referral to the municipality health center for a lifestyle change program and/or follow the procedures for diagnostics and treatment. This will follow the usual medical standards in general practice. For individuals with abnormal screens or health behavior amenable to intervention at the first health check an additional health check will be scheduled six months after the first health check with a follow-up consultation for review of the results."
16124183|NCT01979081|Other|Tailored advice from a physiotherapist and/or an occupational therapist through the myOSCAR patient portal|
16124184|NCT01979055|Behavioral|Self-regulation intervention|6 session educational intervention (3 telephone, 3 In-person), led by a health educator
16124185|NCT01979055|Behavioral|Telephone follow-up|Usual care group, will also receive 3 telephone calls to assess any questions they may have about asthma
16124186|NCT01979029|Procedure|preserving the left colic artery|The root of the inferior mesenteric artery(IMA) was carefully dissected and the artery wall was exposed all the way to the bifurcation of the left colic artery(LCA) and the superior rectal artery (SRA), exposing the LCA from its root until the inferior mesenteric vein (IMV) was recognized. Subsequently, dissection was continued along the IMV up to the level of the root of the IMA. Then the sigmoid mesentery was transected from the root of the IMA to the IMV, and the IMV and the root of the SRA were ligated. Finally, the adipose tissue with the lymph nodes in the area surrounded by the IMA, IMV, and LCA was dissected, with preservation of the LCA .
16124309|NCT01978015|Drug|bimatoprost and timolol maleate fixed combination|bimatoprost0.03% and timolol maleate 0,5%, 1 eye drop at 8 p.m for 6 months
16124187|NCT01979029|Procedure|not preserving the left colic artery|The root of the IMA was exposed and the fatty tissue around the root of the IMA was swept in order to maximize the lymph node retrieval rate. Subsequently, the IMA was ligated 1 cm from the aorta to avoid damaging the nerves.
16124188|NCT01979016|Drug|Dupilumab|
16124189|NCT01979016|Drug|Placebo|Matching placebo
16124190|NCT01979016|Other|Background treatment|Participants were required to apply stable doses of a topical emollient (moisturizer) twice daily for at least 7 days before the baseline visit and at least 7 days after the baseline visit (day -7 to day 8).
16124191|NCT01979003|Drug|Fluorescein|
16124192|NCT01978964|Biological|ONT-10|ONT-10 is a liposomal synthetic glycopolypeptide antigen formulated with PET Lipid A adjuvant
16124193|NCT01978951|Behavioral|Integrated Chronic Kidney Disease care|Activities of integrated CKD care program, which will be provided during each hospital visit and quarterly home visits, are live demonstration about treatment and optimal diets for CKD patients, monitor drug compliance.
16124194|NCT01978951|Behavioral|Conventional CKD care|group counselling about optimal diets for CKD patients
16124195|NCT01978938|Drug|Eravacycline|
16124196|NCT01978938|Drug|Levofloxacin|
16124197|NCT01978925|Other|Pharmaceutical care|"The clinical pharmacist will provide a structured 30-minute intervention for enhancing their medication adherence.
~The recommendations include: discussion on hypertension and/or diabetes, risk of complications, prescribed drug therapy, correct use of medications and proper dosage, possible adverse effects, route of administration, schedule of administration and correct storage. The pharmacist will also emphasize the importance of lifestyle modifications. Printed educational material, with information on hypertension and/ or diabetes medications, including suggested lifestyle interventions was prepared to assist in the intervention and will be handed to patients in the end of the session."
16124198|NCT01978912|Drug|KTP-001|KTP-001 is one time dose intradiscally.
16124199|NCT01978899|Behavioral|Immediate Weight Loss Program Group|Participation in 15-week Healthy Living Program.
16124200|NCT01978899|Behavioral|Delayed Weight Loss Program Group|Participation in 15-week Healthy Living Program following 15-week wait period.
16124201|NCT01978873|Drug|Cabazitaxel + Androgen deprivation therapy|Cabazitaxel + LHRH agonist + antiandrogens for 30 days OR surgical castration OR complete androgen blockade (CAB) by LHRH agonist + antiandrogen device.
16124202|NCT01978873|Drug|Androgen deprivation therapy|LHRH agonist + antiandrogens for 30 days OR surgical castration OR complete androgen blockade (CAB) by LHRH agonist + antiandrogen device.
16124203|NCT01978860|Device|NovaCross, CTO|evaluate the safety and performance of the NovaCross™ micro-catheter in respect to providing additional guidewire support that is expected to allow easier crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries.
16124204|NCT01978821|Procedure|Autologous bone marrow mononuclear cell transplantation|
16124205|NCT01978795|Other|Brain 101 website|Brain 101: The Concussion Play book is a web-based, stand-alone guide for school leaders on effective policies and practices in concussion management. Consistent with the literature on effective school-based change efforts, the website offers a comprehensive, school-wide approach to preventing and managing sports concussion, including training for educators, athletics staff, students, and parents. The website presents guidelines for creating a concussion management team (CMT) that meets regularly to support students as they return to academics, extra-curricular activities, and athletics. It also includes information on strategies for supporting students in the classroom following concussion (e.g., designing reduced school schedules, monitoring school performance following concussion).
16124206|NCT01978795|Other|Control|At control schools, parents viewed Centers for Disease Control materials on safe teen drivers. Athletes viewed web-based materials about teens staying safe on the job.
16124207|NCT01978782|Drug|raltegravir|
16124208|NCT01978782|Drug|citalopram|
16124209|NCT01978756|Other|Outpatient clinic|The participants are seen at the outpatient clinic by a physician or a physician assistant. To analyse fibrosis clinical examination of the breast will be performed. To analyse shoulder function anteversion / retroversion, abduction / adduction and internal / external rotation will be measured. To analyse edema the arm circumference will be measured 15 cm above and below the medial epicondyle (both sides). Also, a photograph of the breast will be made for cosmetic analysis using standardized procedures. Finally a blood sample or saliva will be obtained, if the patient has given written informed consent to participate in the Biobank.
16124210|NCT01978743|Drug|Raltegravir|Switch from Atripla to Raltegravir 400mg BID + Truvada (FTC/TDF) for total of 8 weeks
16124211|NCT01978730|Drug|high dose group of SaiLuoTong capsule|high dose group of SaiLuoTong capsule: take three pills (180 mg) of SaiLuoTong capsule each time, twice a day, 0.5 hours after breakfast and dinner, taking with lukewarm water.
16124212|NCT01978730|Drug|low dose group of SaiLuoTong|low dose group of SaiLuoTong capsule: take two pills (120 mg) of SaiLuoTong capsule plus one pill of placebo (analog SaiLuoTong capsule) each time, twice a day, 0.5 hours after breakfast and dinner, taking with lukewarm water.
16124213|NCT01978730|Drug|the control group|The control group is randomly divided into two groups by 1:1. During the first 26 weeks, all subjects will take three pills of placebo each time, twice a day. During the last 26 weeks, the subjects in the placebo group will take two pills of SaiLuoTong plus one pill of placebo or three pills of SaiLuoTong each time, twice a day.
16124214|NCT01978717|Procedure|epidural anesthesia|
16124215|NCT01978717|Procedure|general anesthesia|Patients received general anesthesia for surgery
16124216|NCT01978704|Other|Adjustment of pre-prandial insulin doses on the bases of glycaemic load of the meal|
16124217|NCT01978704|Other|Adjustment of pre-prandial insulin doses on the bases of carbohydrates content of the meal|
16124218|NCT01978691|Dietary Supplement|Bifidobacterium animalis ssp. lactis 420|Studied as a probiotic bacteria
16124219|NCT01978691|Dietary Supplement|Polydextrose|Studied as a prebiotic
16124220|NCT01978691|Other|Placebo|Control
16124221|NCT01978678|Drug|Pulmicort|ACQ and FeNO
16124222|NCT01978665|Drug|prednisone|similar size tablets
16124223|NCT01978652|Biological|Peginterferon Beta-1a|As specified in the treatment arm
16124224|NCT01978626|Behavioral|App modules|
16124225|NCT01978626|Behavioral|Traditional CBT-I|
16124310|NCT01978015|Drug|dextran and hypromellose|Dextran 70 and hypromellose, lubricant eye drop at 8 a.m and 8 p.m for 6 months
16124226|NCT01978613|Drug|NNC0113-0987|Tablets for once-daily oral administration. Multiple doses with sequential dose increments over 10 weeks. The end-dose levels and the dose levels during the escalation regime may be adapted during trial conduct based on safety evaluations.
16124227|NCT01978613|Drug|placebo|Tablets for one-daily oral administration.
16124228|NCT01978600|Drug|Brinzolamide 1%/Brimonidine 0.2% ophthalmic suspension|Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.
16124229|NCT01978600|Drug|Timolol Maleate 0.5%|Commercially marketed and approved for lowering IOP in patients with open-angle glaucoma and ocular hypertension.
16124230|NCT01978587|Drug|JTZ-951|
16124231|NCT01978574|Behavioral|Intellectual Enrichment daily activities|A daily program of intellectually enriching, iPad/tablet-based activities: games, reading/writing, hobby activities, or a documentary video (control).
16124232|NCT01978574|Behavioral|Intellectual Enrichment documentary videos|Participants watch daily documentary videos.
16124233|NCT01978561|Biological|Post dosing with NT100|
16124234|NCT01978561|Other|Post dosing with Placebo|
16124235|NCT01978548|Drug|JNJ-54861911 10 mg|JNJ-54861911 10 mg will be administered as two 5 mg oral tablets once daily.
16124236|NCT01978548|Drug|JNJ-54861911 50 mg|JNJ-54861911 50 mg will be administered as two 25 mg oral tablets once daily.
16124237|NCT01978548|Drug|Placebo|Matching placebo will be administered as 2 oral tablets once daily.
16124238|NCT01978535|Drug|Iron infusion|5 mg/kg of intravenous iron sucrose supplied as Venofer (TM) with a maximum dose of 200mg. Iron sucrose will be diluted to 1 mg of elemental iron in 1 mL of NaCl 0.9% with a maximum volume of 210 mL.
16124239|NCT01978535|Drug|Normal saline infusion|Normal saline (NaCl 0.9%) 5 mL/kg up to a maximum volume 210 mL
16124240|NCT01978522|Other|Randomisation of questionnaire receipt.|"The self-completion questionnaire will be delivered to the participants via post a week after completing the CAPI.
~Self-completion questionnaire handed to participants immediately after completing the CAPI."
16124241|NCT01978509|Drug|Low volume prep (Prepopik)|Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy.
16124242|NCT01978509|Drug|Moderate volume prep (Moviprep)|Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy.
16124243|NCT01978509|Drug|High volume prep (Golytely)|Hospitalized patients will be randomized to receive either large volume bowel preparation (Golytely), moderate volume bowel prep (Moviprep) or low volume bowel preparation (Prepopik) in a split dose manner for bowel cleansing prior to colonoscopy.
16124244|NCT01978496|Drug|Placebo|matching placebo
16124245|NCT01978496|Drug|Eletriptan 20 mg|20mg oral
16124246|NCT01978496|Drug|Eletriptan 40 mg|40mg oral
16124247|NCT01978496|Drug|Eletriptan 80 mg|80mg oral
16124248|NCT01978483|Drug|Denosumab|
16124249|NCT01978483|Radiation|UVB exposure|
16124250|NCT01978483|Drug|Diphenylcyclopropenone|
16124251|NCT01978483|Drug|Normal Saline|
16124252|NCT01978470|Device|External Trigeminal Nerve Stimulation (eTNS)|External stimulation of the trigeminal nerve.
16124253|NCT01978457|Drug|cocaine hydrochloride|
16124254|NCT01978457|Drug|propranolol|
16124255|NCT01978457|Drug|placebo|
16124256|NCT01978444|Procedure|Laparoscopic D2 lymphadenectomy plus CME|
16124257|NCT01978444|Procedure|Laparoscopic D2 lymphadenectomy|
16124258|NCT01978431|Drug|cocaine hydrochloride|
16124259|NCT01978431|Drug|methylphenidate|
16124260|NCT01978418|Drug|salbutamol|Medication given once as a dose of 4 puffs at 30-60 minutes of age
16124261|NCT01978418|Drug|Placebo|Placebo given once as a dose of four puffs at 30-60 minutes of age
16124262|NCT01978405|Drug|Alpha lipoic acid|
16124263|NCT01978392|Behavioral|Self-management group workshops|This intervention consists of multiple group workshop sessions (10 hours total) led by a specially trained facilitator and provided over a span of approximately 2-3 months. The intervention incorporates standard elements of existing evidence-based pain and illness self-management efforts, but tailoring key messages and discussion elements to apply to workplace problems most relevant to workers with chronic medical conditions. Each session is focused on different self-management strategies, with each session containing a mix of facilitator presentation, group discussion, case illustrations, role-play, completion of in-session self-assessments and activities, and brief homework assignments. Approximately equal time is allocated to the topics of improving comfort, modifying work, communicating effectively, applying systematic problem-solving strategies, and dealing with negative thoughts and emotions.
16124264|NCT01978366|Drug|HT-100|May be administered in either fed or fasted state
16124265|NCT01978353|Behavioral|Memory Training|Participants receive memory training to facilitate learning and memory of face-name associations
16124266|NCT01978353|Behavioral|Psychoeducation|Participants receive information about memory functioning and aging
16124267|NCT01978327|Drug|GSK2647544|repeat dose
16124268|NCT01978327|Drug|drug-drug interaction|drug-drug interaction
16124269|NCT01978314|Device|75 mg / 6 mL VFI™|Visible fluorescent injectate, a mixture of two different molecular weight carboxymethyl dextran molecules (5 kD and 150 kD) with different fluorescent dye molecules attached.
16124270|NCT01978301|Drug|Triamcinolone acetonide|Triamcinolone acetonide will be administered as intra-lesional injection in the keloid(s).
16124271|NCT01978301|Drug|Placebo|Placebo will supplied as commercial injectable saline, and will be administered as intra-lesional injection in the keloid(s).
16124272|NCT01978275|Device|stimulong 100, pajunk, germany|simulating catheter
16124273|NCT01978275|Device|plexolong 100, pajunk, germany|nonstimulating catheter
16124274|NCT01978262|Biological|Seasonal Inactivated Influenza Vaccine|Quadrivalent seasonal inactivated influenza vaccine, 0.5 mL intramuscularly
16124275|NCT01978249|Procedure|Systemic chemotherapy|
16124276|NCT01978249|Procedure|primary tumor resection (PTR)|primary tumor resection (PTR) using open or laparoscopy or robotic surgery
16124311|NCT01978002|Behavioral|Pain sensitivity testing|
16124312|NCT01978002|Behavioral|Urodynamic testing|
16124277|NCT01978236|Drug|Dabrafenib 150 mg|Dabrafenib will be provided for oral administration as 50 mg and 75 mg capsules. Dabrafenib will be dosed orally with approximately 200 mL of water, twice a day. Dabrafenib should be administered under fasting conditions.
16124278|NCT01978236|Drug|Trametinib 2.0 mg|Trametinib study treatment will be provided as 0.5 mg and 2.0 mg tablets. should be taken orally with approximately 200 mL of water under fasting conditions, either one hour before or two hours after a meal.
16124279|NCT01978223|Procedure|Stool sample collection|Stool samples will be collected from all children enrolled in the study, within 48 hours of admission to the hospital/ ED. Stool samples will be tested to determine the presence or absence of rotavirus (RV). Additionally, for RV-positive cases, the stool samples will be tested to determine the RV genotypes.
16124280|NCT01978210|Device|Wireless Moisture Pager (WMP)|The WMP is composed of a three key components: (1) the disposable sensor; (2) the transmitter; and (3) the receiver. The disposable sensor is placed by the parent in the child's underwear and detects small amounts of urine. The transmitter is housed in hardened plastic, attached to the disposable sensor, and, upon activation, emits a radio signal to the receiver. The receiver is an iPod-based app that emits an audible and/or vibration signal to the parent and child at the onset of a toileting accident. A step-by-step manualized curriculum is used to teach parents how to incorporate the device in the toilet training of their child.
16124281|NCT01978184|Drug|gemcitabine|
16124282|NCT01978184|Drug|abraxane|
16124283|NCT01978184|Drug|hydroxychloroquine|
16124284|NCT01978158|Drug|Lipopolysaccharide|LPS is used to elicit an inflammatory response in all subjects
16124285|NCT01978145|Drug|FSC|Subject will be administered FSC 250 mcg/50 mcg via dry powder inhalation device -or multi-dose dry powder inhalation device BID for each treatment periods
16124286|NCT01978145|Drug|Placebo|Subject will be administered placebo via dry powder inhalation device or multi-dose dry powder inhalation device BID for each treatment periods
16124287|NCT01978132|Procedure|forearm ischemia and reperfusion|both arms will be subjected to 20 minutes of forearm ischemia and 20 minutes of reperfusion.
16124288|NCT01978119|Drug|FSC|Subject will be administered FSC 250 mcg/50 mcg via dry powder inhalation device or multi-dose dry powder inhalation device BID for each treatment period
16124289|NCT01978119|Drug|Placebo|Subject will be administered placebo via dry powder inhalation device or multi-dose dry powder inhalation device BID for each treatment period
16124290|NCT01978093|Biological|Hib-MenCY-TT (MenHibrix®)|4 doses administered intramuscularly (IM) in the right upper anterolateral thigh at Day 0, Month 2, Month 4 and Month 10-13 in the HibCY Group.
16124291|NCT01978093|Biological|Pediarix®|3 doses administered IM in the left upper anterolateral thigh at Day 0, Month 2 and Month 4. 2 doses administered IM in the left upper anterolateral thigh at Day 0 and Month 2 and 1 dose administered IM in the right upper anterolateral thigh at Month 4 in the PedHIB Group.
16124292|NCT01978093|Biological|Rotarix®|2 doses administered orally at Day 0 and Month 2 each in the HibCY Group and PedHIB Group.
16124293|NCT01978093|Biological|Prevnar 13®|4 doses administered IM in the left lower anterolateral thigh at Day 0, Month 2, Month 4 and Month 10-13 each in the HibCY Group and PedHIB Group.
16124294|NCT01978093|Biological|PedvaxHIB®|3 doses administered IM in the right upper anterolateral thigh at Day 0, Month 2 and Month 10-13 in the PedHIB Group.
16124295|NCT01978093|Biological|Havrix®|2 doses administered IM in the left upper anterolateral thigh at Month 10-13 and Month 16-19 each in the HibCY Group and PedHIB Group.
16124296|NCT01978080|Device|Kinesia HomeView|
16124297|NCT01978067|Procedure|transvaginal resection of Uterine Scar|Expose, grasp and traction the cervix. An incision was made at the anterior cervicovaginal junction, and the bladder was dissected away until the anterior peritoneal reflection was identified. The anterior drawing hook was inserted.into the vaginal incision to retract the bladder upwards. The PCSD was identified as a'fornix' located in the anterior part of the lower uterine segment. A transverse incision was made to remove the scar deficiency, and the edges of the incision were trimmed with scissors, and the myometrial and vaginal defects were closed.
16124298|NCT01978054|Other|Dissemination of public health knowledge|State health department chronic disease units will be involved with developing and choosing dissemination activities to spread public health knowledge and information on population-based public health strategies that have been shown to reduce risk factors for cancer and other chronic diseases. Example of activities include: multi-day in-person training workshops and electronic information exchange modalities.
16124299|NCT01978041|Other|Meal prepared with non fluoridated water|Ingestion of a typical brazilian meal (rice, beans, meat, french beans, carrots, gelatin and juice) prepared with purified water containing a fluoride dose of 0.8 ug of fluoride/kg body weight (resulting of the natural fluoride concentration in foods).
16124300|NCT01978041|Other|Meal prepared with fluoridated water|Ingestion of a typical brazilian meal (rice, beans, meat, french beans, carrots, gelatin and juice) prepared with fluoridated water (1 ug of fluoride/mL), to provide a total intake of approximately 12 ug of fluoride/kg body weight.
16124301|NCT01978041|Other|Non fluoridated water|Ingestion of purified water with addition of fluoride to provide a total intake of approximately 0.8 ug of fluoride/kg body weight, which represented the same fluoride ingestion dose of the experimental phase with meal prepared with non fluoridated water.
16124302|NCT01978041|Other|Fluoridated water|Ingestion of fluoridated water (1 ug F/mL), to provide a total intake of approximately 12 ug of fluoride/kg body weight.
16124303|NCT01978041|Other|Meal prepared to provide a fluoride dose of 60 ug F/kg|Ingestion of a typical Brazilian meal (rice, beans, meat, french beans, carrots, gelatin and juice) prepared with non-fluoridated water, with sodium fluoride solution added to the juice to provide a total intake of approximately 60 ug of fluoride/kg body weight.
16124304|NCT01978041|Other|Meal prepared to provide a fluoride dose of 120 ug F/kg|Ingestion of a typical Brazilian meal (rice, beans, meat, french beans, carrots, gelatin and juice) prepared with non-fluoridated water, with sodium fluoride solution added to the juice to provide a total intake of approximately 60 ug of fluoride/kg body weight.
16124305|NCT01978028|Drug|ferric carboxymaltose|
16124306|NCT01978028|Drug|placebo|
16124307|NCT01978015|Drug|travoprost and timolol maleate fixed combination|travoprost 0.004% and timolol maleate 0,5%, 1 eye drop at 8p.m. for 6 months
16124308|NCT01978015|Drug|latanoprost and maleate timolol fixed combination|Latanoprost 0.005% and timolol maleate 0,5%, 1 eye drop at 8 p.m for 6 months
16124313|NCT01977989|Drug|Vancomycin Powder|For surgeries involving 3 contiguous spinal segments or less, 500mg of vancomycin will be applied topically. For surgeries involving more than 3 contiguous spinal segments, 1gm of vancomycin will be applied topically to the surgical site.
16124314|NCT01977976|Procedure|Endometrial aspiration by pipelle|Endometrial aspiration by pipelle is to be performed on LH+7 in the cycle preceding scheduled IVF treatment
16124315|NCT01977937|Drug|Gabapentin 250mg/5mL NDC:59762-5025-01|
16124316|NCT01977937|Drug|Simple Syrup|
16124317|NCT01977924|Dietary Supplement|one month polyphenols supplementation (600mg)|
16124318|NCT01977924|Dietary Supplement|placebo (microcrystalline cellulose)|
16124319|NCT01977911|Other|Stem cell based tissue engineered partial laryngeal implants|Stem cells from the patient receiving the implant are removed from the bone marrow, and are then grown on the scaffold in the laboratory. These cells will form the cartilage in the wall of the scaffold. The implant can be considered 'living' due to the cells grown on it, and this type of treatment is referred to as 'tissue engineering' or 'regenerative medicine'. Once these cells have attached and started to grow on the scaffold, it is ready to be implanted into the patient and a two separate operative stages can occur. The final stage of the operation involves removing the narrow section of voicebox or upper windpipe and implanting the scaffold to reconstruct it.
16124320|NCT01977898|Drug|Morphine|The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.
16124321|NCT01977898|Drug|Saline|The drug will be prepared in tuberculin syringes. After thoroughly sanitizing the catheter port with a Chloroprep wipe and allowing adequate time for drying of the Chloroprep, the anesthesiologist will first attach a 3-mL syringe to the catheter port and aspirate to a volume of 1 mL. This syringe will then be removed from the port. The study drug will then be administered through the intrathecal catheter via the tuberculin syringe. The 3-mL syringe containing the aspirate will then be injected via the catheter, effectively flushing the study drug through the catheter. The intrathecal catheter will be removed immediately following the injection.
16124322|NCT01977885|Behavioral|High Protein Diet|All participants will be individually counseled by an RD for ~ 4 sessions (30 to 60 minutes)to meet weight loss goals. During the duration of the study, participants will be required to attend a 30 to 60 minute group educational/motivational meeting weekly (first 1 to 2 months) and then biweekly (for the remainder of the study). Diet recommendations will include high quality proteins with an emphasis on lean meats with protein being targeted for every meal and snack. Regarding beef intake specifically, the prescribed diet will include a minimum of one serving of beef per day, which is approximately 3 to 3.5 ounces or ~100 grams. This amount of lean cooked beef provides an average of ~25-30 grams of protein per day (www.beefnutrition.org/leanbeef.aspx). This combined with reducing energy from carbohydrates and fat from other sources will create an overall energy deficit of 500 kcal/day. This diet will also include 5 servings/day of vegetables and 2-3 servings/day of fruit
16124323|NCT01977885|Behavioral|Exercise|Participants will be prescribed a supervised exercise program with required attendance of 3 nonconsecutive days per week (75 minutes each session). A program that combines flexibility and balance activities, weight bearing endurance exercise (walking) and resistance training to preserve lean mass will be prescribed. With specific regard to strength training, 50% of the resistance work will involve primary muscle groups of the lower body with the main focus being the gluteal and quadriceps groups (squats, lunges, etc.). The remaining 50% of work will dedicate 25% to the core stabilizers with the final 25% being the upper body. Transitions between segments of training will be used for recovery and social support enhancement. Note that all aspects of the exercise intervention will be progressive in intensity (i.e., starting at lower end of intensity or ~50% of maximal capacity), and duration (i.e., from 15 minutes to 35 minutes of exercise and adding a few minutes each session).
16124324|NCT01977872|Behavioral|A worksite activity-diet intervention|
16124325|NCT01977859|Drug|Nesiritide|
16124326|NCT01977859|Drug|Saline|
16124327|NCT01977833|Other|High Calorie Breakfast (BTdiet)|High Caloric Breakfast Test Diet (BTdiet): in which the majority of energy load will be consumed in the morning and with reduced dinner
16124328|NCT01977833|Other|High Caloric Dinner (DTdiet)|High Caloric Dinner (DTdiet): resembling a skipping breakfast plan, in which the majority of energy load will be consumed in the evening with minimal caloric content at breakfast
16124329|NCT01977820|Drug|Sapropterin|Sapropterin tablets will be administered orally once daily at a dose of 20 milligram per kilogram (mg/kg) during both the 2-Week response test period and 24-Week study period.
16124330|NCT01977820|Drug|Placebo|Sapropterin tablets will be administered orally once daily at a dose of 20 milligram per kilogram (mg/kg) during both the 2-Week response test period and Placebo tablets matching to sapropterin will be administered orally once daily during the 24-Week study period.
16124331|NCT01977807|Device|Proscan, Zyoptix and Supracor|One device (500 Hz Excimer Laser) with three interventions (Proscan, Zyoptix and Supracor as algorithms)
16124332|NCT01977794|Drug|Bisoprolol/Amlodipine (Bisoprolol failed group)|Bisoprolol/Amlodipine FDC tablet will be orally administered at an initial dose of 5 mg/5 mg once daily for 6 weeks. If blood pressure (BP) is controlled at Week 6 (Day 43), the same dose will continue for next 6 weeks. If the BP is not controlled at Day 43, the dose will be increased to Bisoprolol/Amlodipine 5mg/10mg or 10mg/5mg for next 6 weeks. Subjects who have controlled BP at Week 12 (Day 85), will continue with the same dose for next 6 weeks. If their BP is not controlled at Day 85, dose will be increased to the next level (Bisoprolol/Amlodipine 5mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/5mg dose and Bisoprolol/Amlodipine and 10mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18 (Day 127).
16124370|NCT01977495|Behavioral|Financial Incentive: Fixed Lottery|Every day of the 91 day intervention period participants will be asked to use each of their biometric devices. A daily lottery will be conducted automatically by the study website. Participants must use each of their two devices daily to be eligible for the lottery the following day. Winning lottery numbers will be identified by a fixed-position match between the automatically generated winning number and a participant ID number, which each participant will pick at enrollment.
16124333|NCT01977794|Drug|Bisoprolol/Amlodipine (Amlodipine failed group)|Bisoprolol/Amlodipine FDC tablet will be orally administered at an initial dose of 5 milligram (mg)/5 mg once daily for 6 weeks. If BP is controlled at Week 6 (Day 43), the same dose will continue for next 6 weeks. If the BP is not controlled at Day 43, the dose will be increased to Bisoprolol/Amlodipine 5mg/10mg or 10mg/5mg for next 6 weeks. Subjects who have controlled BP at Week 12 (Day 85), will continue with the same dose for next 6 weeks. If their BP is not controlled at Day 85, dose will be increased to the next level (Bisoprolol/Amlodipine 5mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/5mg dose and Bisoprolol/Amlodipine and 10mg/10mg for subjects receiving Bisoprolol/Amlodipine 5mg/10mg dose) until Week 18 (Day 127).
16124334|NCT01977781|Drug|Tacrolimus|Topical bilateral application of 0.05% Tacrolimus BID for 10 weeks
16124335|NCT01977781|Drug|Methylprednisolone Sodium Succinate|Topical bilateral application of 0.5% methylprednisolone sodium succinate BID for 10 weeks
16124336|NCT01977768|Biological|V7|One pill of V7 once daily for 30 days together with standard of care TB drugs
16124337|NCT01977768|Biological|Placebo|
16124338|NCT01977755|Drug|danegaptide|
16124339|NCT01977755|Drug|Placebo|
16124340|NCT01977742|Other|Supervised exercise program|Aerobic, strength and flexibility exercises in a supervised exercise program for 8 weeks; after 8 weeks will add a specific sudden rest-exercise training protocol, three times a week. The cardiac vagal index will be measured at every 8 weeks.
16124341|NCT01977742|Other|Supervised exercise program together with a specific sudden rest-exercise training protocol|Aerobic, strength and flexibility exercises in a supervised exercise program for 8 weeks together with a specific sudden rest-exercise training protocol, three times a week After 8 weeks will discontinue the specific sudden rest-exercise training protocol. The cardiac vagal index will be measured at every 8 weeks.
16124342|NCT01977729|Drug|Sertraline|"Medication will be administered daily using a fixed-flexible strategy beginning at 25mg, titrating to 200mg across 8 wks (i.e., wks 9-17). We expect patients' medication dose will be adjusted upward in 50 mg/day increments if clinician-rated CGI-S anxiety severity is 3 (mild) or greater. The dose will be held or adjusted downward if patients have few anxiety symptoms (CGI-S<3) or impairing Adverse Events. Patients will be maintained at 200mg per day during wks 18-20."
16124343|NCT01977729|Behavioral|Cognitive Behavioral Therapy|Youth are given instructions in each session that they may stop whenever they want and they do not need to attempt the task unless they so desire. Therapists have been carefully and thoroughly trained in providing reassurance and/or crisis treatments if needed. Therapists also have been trained to contact one of the PIs immediately in the event of a crisis.
16124344|NCT01977703|Other|Ultra Conservative ICD Programming|
16124345|NCT01977703|Other|Traditional ICD Programming|
16124346|NCT01977690|Device|Clavicle Brace|
16124347|NCT01977677|Radiation|radiation therapy|Undergo radiation therapy
16124348|NCT01977677|Drug|temozolomide|Given PO
16124349|NCT01977677|Drug|plerixafor|Given IV
16124350|NCT01977677|Other|laboratory biomarker analysis|Correlative studies
16124351|NCT01977677|Other|pharmacological study|Correlative studies
16124352|NCT01977664|Other|no intervention|
16124353|NCT01977651|Drug|Enzalutamide|Participants received 4 capsules (40 mg each) of enzalutamide orally once a day, for a total daily dose of 160 mg. Treatment was given with or without food and as close as possible to the same time each day.
16124354|NCT01977638|Drug|CXD101|Capsules, administered orally
16124355|NCT01977625|Drug|Lisdexamfetamine|The overall objective of this study is to assess the effects of LDX on brain activation patterns during tasks of sustained attention and working memory in menopausal women.
16124356|NCT01977625|Other|Placebo|To assess the effects of a placebo pill on brain activation patterns during tasks of sustained attention and working memory in menopausal women.
16124357|NCT01977612|Device|4-0 monofilament suture|Skin closure using 4-0 monofilament suture
16124358|NCT01977612|Device|Stainless steel staples|Skin closure using stainless steel staples.
16124359|NCT01977599|Other|Text Message Reminder for Breast Screening Appointment|Non-clinical/administrative.
16124360|NCT01977586|Other|Magnetic Resonance Imaging (MRI)|
16124361|NCT01977573|Drug|GSK1278863|Film-coated tablets containing 0.5 mg, 1 mg, 2 mg, 5mg or matching placebo
16124362|NCT01977573|Drug|rhEPO|Locally sourced rhEPO. All subjects who are randomized to the Control arm will receive rhEPO (epoetins or their biosimilars, or darbepoetin) as necessary per standard of care, to maintain Hgb levels within the target range. The decision around whether a subject requires rhEPO, selection of the type of rhEPO and rhEPO dose should be based on Investigator clinical judgment, with the historical rhEPO dose (where applicable) and the current Hgb value being considered..
16124363|NCT01977560|Behavioral|Optimum Lifestyle Intervention|Participants will follow a high-protein, low-carbohydrate diet and participate in supervised exercise.
16124364|NCT01977560|Behavioral|Standard Care|Participants will be given advice on exercise and the American Diabetes Association diet, as if they went to a Diabetes clinic.
16124365|NCT01977547|Biological|Short storage RBC age|IND obtained to cover the expiration date on the red blood cell unit
16124366|NCT01977534|Device|Absorb BVS|The Absorb BVS System is a bioresorbable poly(L-lactide) (PLLA) scaffold with a drug and bioresorbable polymer coating [formulation of everolimus in a bioresorbable poly(D,L-lactide) (PDLLA) coating].
16124367|NCT01977521|Device|Eldith DC Stimulator stimulation|The anodal electrode will be placed with the middle of the electrode over a point midway between F3 and FP1 (left prefrontal cortex: dorsolateral prefrontal cortex and the cathodal electrode located over a point midway between T3 and P3 (left temporo-parietal junction). Stimulation will consist of 2 mA for 20 minutes per session.
16124368|NCT01977521|Device|Eldith DC Stimulator sham stimulation|The anodal electrode will be placed with the middle of the electrode over a point midway between F3 and FP1 (left prefrontal cortex: dorsolateral prefrontal cortex and the cathodal electrode located over a point midway between T3 and P3 (left temporo-parietal junction). In the sham condition, after 40 seconds of real stimulation (2 mA), only a small current pulse will occur every 550 msec (110 mA over 15 msec) through the remainder of the 20-minute period.
16124369|NCT01977508|Device|ePTFE vascular access grafts|
16124371|NCT01977482|Drug|GSK1278863|Film coated tablets containing 1 mg, 2 mg, 5 mg, or 25 mg of GSK1278863
16124372|NCT01977482|Drug|Placebo|Matching placebo tablet for GSK1278863
16124374|NCT01977469|Behavioral|Low intensity resistance training|The LIRT group initiated the resistance training for UL with 30% of the 1RM, with 5% increases each nine sessions; therefore, the maximum load was 45% of the 1RM. The LL training initiated with 30% of the 1RM, increasing 7% each nine sessions, thus, the maximum load was 51% of the 1RM. Each exercise session consisted of three sets of 15 repetitions, with a 2 minutes interval between sets.
16124375|NCT01977469|Behavioral|High intensity resistance training|the initial load for HIRT group was 60% of 1RM for UL with 5% increases each nine sessions; therefore, the maximum load reached 75% of the 1RM. The LL training initiated with 60% of the 1RM with 7% increments each nine sessions, as a result, the maximum load after 36 sessions was 81% of the 1RM. These patients underwent three sets of eight repetitions, with two minutes intervals between sets.
16124376|NCT01977469|Behavioral|Aerobic training|Patients underwent an aerobic training in cycle ergometer, with load intensity determined as the same load the patient presented a VO2 value of 70-80% of the peak VO2 obtained in the symptom-limited CPET. Each session of aerobic training lasted 20-30min according to patient's tolerance.
16124377|NCT01977456|Drug|Eptifibatide|IV Eptifibatide is an approved drug by the Food and Drug Administration as a treatment for blood clots causing heart attack and chest pain.Eptifibatide inhibits platelet aggregation by blocking activated platelets from binding fibrinogen.
16124378|NCT01977443|Drug|APD-209 Eye drops|
16124379|NCT01977443|Drug|APD-209 Placebo Eye drops|
16124380|NCT01977430|Drug|Hydrochlorothiazide and furosemide|This clinical trial is cross-over study. The diuretic arm's patients will receive combined diuretic treatment for 1 month: 20 mg of furosemide three times daily and 50 mg of hydrochlorothiazide twice daily
16124381|NCT01977417|Drug|Salsalate|
16124382|NCT01977417|Drug|Placebo|
16124383|NCT01977378|Drug|Sustained-Release Desvenlafaxine Hydrochloride|
16124384|NCT01977378|Drug|Sustained-Release Venlafaxine Hydrochloride|
16124385|NCT01977365|Behavioral|Growth promotion based on child centered approach|"- Preventive consultations will be reorganized. From the child birth, a follow-up schedule will be establish in agreement with the mother, and the subsequent appointment will be renew at each meeting.
~Ten contacts will be organized for children under two years. During the first year, the number of contacts will be limited to 6 at birth , 2 , 3, 4 and 9 months to complete the vaccination schedule and an additional contact at 7 months to allow monitoring during the introduction of complementary foods.
~Four contacts will be held for the second year to 12, 15, 18 and 24 months to monitor the transition from complementary food to the family diet.
~- Inclusion of Child Centered growth promotion approach. During preventive consultations, specific messages according to the child age, health and nutritional status will be developed, based on scientific evidences and adapted to the experience and knowledge of health workers."
16124386|NCT01977352|Drug|Liposomal bupivacaine|liposomal bupivacaine (EXPAREL®; 88 mg in 20 cc)
16124387|NCT01977352|Drug|Bupivacaine 0.25%|20 cc of bupivacaine 0.25%
16124388|NCT01977339|Drug|Liposome Bupivacaine|10 cc of 266 mg liposome bupivacaine with 10 cc of Normal Saline
16124389|NCT01977339|Drug|Bupivacaine|20 cc of 0.25% bupivacaine
16124390|NCT01977326|Behavioral|basic counselling by lay-health workers|6 sessions of manual based counselling by trained lay health workers
16124391|NCT01977326|Other|Enhanced usual care|3 monthly phone calls by trained lay health workers (without counselling)
16124392|NCT01977300|Drug|Valproate|serum level of 50 to 125 ug/L
16124393|NCT01977300|Drug|Lithium|serum levels of 0.6 to 1.2 mmol/L
16124394|NCT01977300|Drug|Risperidone|1 to 6 mg/day
16124395|NCT01977300|Drug|Olanzapine|5 to 25 mg/day
16124396|NCT01977300|Other|Placebo|manufactured to mimic risperidone and olanzapine
16124397|NCT01977287|Device|Functional Electrical Stimulation|
16124398|NCT01977287|Device|Ankle Foot Orthosis|
16124399|NCT01977274|Other|gynecological cancer|blood and tumor samples
16124400|NCT01977261|Procedure|Opening-wedge HTO|Opening-wedge high tibial osteotomy fixated with a Puddu plate
16124401|NCT01977261|Procedure|Closing-wedge HTO|Closing-wedge high tibial osteotomy fixated with two staples
16124402|NCT01977248|Behavioral|Sensorimotor Affect Relationship-based Therapy (SMART)|The SMART Program is an interdisciplinary program that teaches children ages 2-12.5 the fundamental skills necessary to build and maintain relationships. Sessions last for 12 weeks at a time and address skills such as: tolerance for sitting and structure, joint attention, eye contact, transitions between activities, participation in group activities, communication skills, and play skills.
16124403|NCT01977235|Drug|Irinotecan|
16124404|NCT01977235|Drug|Cisplatin|
16124405|NCT01977222|Device|THRESHOLD(TM) INSPIRATORY MUSCLE TRAINER|Subjects will be provided with noseclips and a threshold impedance device set to 40% of their measured maximal inspiratory pressure and will be trained on using the device. Specifically, subjects will be instructed to breathe through the inspiratory muscle training device while wearing noseclips at a rate of 12 to 16 breaths per minute for 30 minutes a day, 5 days a week for 12 consecutive weeks. Each subject will be provided a customized schedule for increasing resistance by 2 cm H2O every 2 weeks to a maximum resistance of 41 cm H2O.
16124406|NCT01977209|Drug|Gossypol|
16124407|NCT01977209|Drug|Placebo|
16124408|NCT01977196|Biological|DPT/HepatitisB/Hib vaccine|DPT/HepatitisB/Hib vaccine (Bio Farma)
16124409|NCT01977183|Dietary Supplement|MSPrebiotic|Potato Resistant Starch
16124410|NCT01977170|Biological|Hib/PRP-T vaccine|Hib liquid vaccine
16124411|NCT01977157|Device|bioimpedance mesurements|Bioimpedance measurements were conducted with a BIS device (SFB7, ImpediMed, Pinkeba, Australia) covering a frequency range between 5 kHz and 1 MHz and an ICG device (Niccomo, medis, Ilmenau, Germany)
16124412|NCT01977144|Other|Comprehensive Chromosomal Screening|
16124413|NCT01977131|Other|Cells|
16124414|NCT01977118|Drug|streptokinase|50000U of injection streptokinase dissolved in 100ml of diluent instilled in to the pancreatic and/or peripancreatic collections via percutaneous catheters and clamped for 2 hours in Streptokinase group. After release of clamp, cavity will be irrigated with 100-500ml of saline. This procedure will be performed thrice daily for five days.
16124415|NCT01977118|Other|Saline irrigation|100 ml of normal saline will be instilled through percutaneous catheters in the pancreatic and/or peripancreatic collections and clamped for 2 hours. After release of clamp, cavity will be irrigated with 100-500ml of saline. This procedure will be performed thrice daily for five days
16124416|NCT01977105|Behavioral|Grow Together peer group|"Participants in this intervention will:
~Participate in Facebook group of 6-10 peers for about 8 weeks, led by a professional group mentor.
~Complete an intervention video activity approximately weekly:
~1. View educational videos addressing topics related to healthy infant growth
~2. Create photos/videos modeling healthy behaviors and post them to the group
~3. Provide and receive feedback on posts
~4. Be encouraged to share information with key caregivers of their child
~Attend group party soon after enrollment, to meet peers and group leader in person.
~Receive text message reminders, 1) to schedule recommended primary care visits for their infant, and 2) to attend appointments scheduled in CHOP Care Network.
~Have basic program information provided to pediatrician to enhance conversation during office visits."
16124417|NCT01977092|Behavioral|Motivational interviewing case management|
16124418|NCT01977092|Behavioral|Resource referrals|
16124419|NCT01977079|Other|procalcitonin|
16124420|NCT01977066|Behavioral|Six months supervised resistance training|progressive resistance training (2x/week), starting at the earliest 8 weeks after surgery until maximum 12 months after the surgery with only low-to-moderate-intensity training during the first 4 weeks.
16124421|NCT01977066|Behavioral|Six months home-based exercise training|Home-based exercise training (2x/week) with initial counseling and weekly telephone contact starting at the earliest 8 weeks after surgery until maximum 12 months after the surgery.
16124422|NCT01977053|Other|Clinical and psychosocial phone calls|"The standard medical supervision is defined as follows:
~Prescription of prophylactics medication (corticoid, antiemetic, cream, mouthwash, etc) at each cycle of chemotherapy.
~Nominative notebook containing details of chemotherapy administered and medical contacts.
~Consultations with psycho-oncologist or psychiatrist (if necessary).
~The intervention further comprises: nurse phone calls the 3rd and the 8th day of the first three cycles of treatment, and personalized medical care according to toxicities reported."
16124423|NCT01977027|Other|Alternate Hand Training or Affected Hand Training|Participants will receive a training intervention with either the Alternate Hand Training Strategy, or Affected Hand Training alone.
16124424|NCT01977001|Device|MigraineBoxTM|
16124425|NCT01976988|Drug|Heparin|Subcutaneous Heparin 5000 Units given in the preoperative area one hour prior to surgery and continued every 8 hours for the remainder of the patients hospital course
16124426|NCT01976962|Radiation|Stereotactic body RT with MR-guided boost|Patients will receive radiotherapy over 5 fractions delivered once per week over 29 days, with 7.25 Gy per fraction to the whole prostate and 8 Gy per fraction to the dominant intraprostatic lesion. There will be a minimum of 120 hours and maximum of 192 hours between fractions. The entire course of treatment should be completed within no less than 27 days and no longer than 30 days.
16124427|NCT01976949|Behavioral|online social-networking intervention|
16124428|NCT01976936|Drug|Low Dose Lovastatin|80 mg daily for 3 days
16124429|NCT01976936|Other|Placebo|Placebo for 3 days
16124430|NCT01976936|Drug|High Dose Lovastatin|640 mg daily for 3 days
16124431|NCT01976923|Drug|Intravitreal bevacizumab|A sterile lid speculum is used to separate the lids. A subconjunctival injection of 1% lidocaine is applied to the inferotemporal quadrant. A 5% povidone iodine solution is used to disinfect the entire conjunctival surface. 1.25 mg / 0.05 mL of bevacizumab is injected using a 30-gauge needle inserted through the inferotemporal pars plana 3.5 mm from the limbus.
16124432|NCT01976923|Procedure|Small-gauge pars plana vitrectomy|
16124433|NCT01976910|Drug|DM-CHOC-PEN|"DM-CHOC-PEN will be dosed @ 39 mg/M2, escalated in 1-patient cohorts at 40% dosage.
~At the 1st DLT - expand to 3-6 patient cohorts/dose with escalations at 33% increments.
~The MTD will be where 2 DLTs are noted and the study is discontinued."
16124434|NCT01976897|Other|Knee flexion measurement 1|The angle of knee flexion during resting, supine position is measured by a first person.
16124435|NCT01976897|Other|Knee flexion measurement 2|The angle of knee flexion during resting, supine position is measured by a second person.
16124436|NCT01976897|Other|Heel - interface pressure measurements|"The pressure analysis system used is the X Sensor X3 model (Xsensor Technology Corporation, Calgary, Canada). The sensor mat is made up of transducer cells, each measuring 1.6 cm^2. The digital signal is transmitted to a PC via a USB port at a sampling frequency of 10Hz. Before each measurement, the sensor mat is calibrated from 10 to 220 mm Hg, according to the manufacturer's recommendations.
~The sheet of pressure sensors is disposed on the dedicated bed. The patient is then asked to take his/her usual position in the supine position and a latency of 5 minutes is observed. The recording time pressure is then performed for 90 seconds in the optical observing time to adapt to changes in media."
16124437|NCT01976871|Drug|Rotigotine|Rotigotine is FDA approved for the treatment of Restless Legs Syndrome at doses of 1 mg/24h, 2 mg/24h, and 3 mg/24h. The prescribed dose of rotigotine may be achieved using single or multiple patches. Subjects will titrate the dose based on discussions with the investigator.
16124438|NCT01976858|Drug|PEX168|A injection administered subcutaneously
16124439|NCT01976845|Drug|Midazolam|Midazolam (20mg) 2 ml IV, in the pre-op area as a premedication
16124440|NCT01976845|Drug|Propofol|Propofol (20mg) 2 ml IV, in the pre-op area as a premedication
16124441|NCT01976845|Drug|Saline|Saline 2 ml IV, in the pre-op area as a premedication
16124442|NCT01976832|Behavioral|Music with movement|Participants in the intervention group will receive the intervention delivered by their family member according to the validated 8-week music with movement (MWM) intervention protocol.
16124443|NCT01976832|Behavioral|Social interaction|"The control group will receive a protocol for social interaction as the control condition, where caregivers were asked to discuss up to date news with PWeD.
~The design of the control condition will be highly similar to the MWM protocol in terms of the frequency and duration of the sessions, the number of people involved, and the total intervention period."
16124444|NCT01976819|Device|TW speaking valve/HME|The TW speaking valve with HME will be used during the day, whereas during sleep patients will use an HME without an automatic speaking valve. Data from TW15 and TW22 will be combined.
16124445|NCT01976806|Drug|Aspirin|
16124446|NCT01976806|Drug|Docosahexaenoic acid|
16124447|NCT01976806|Drug|Placebo (for Docosahexaenoic acid)|Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules
16124448|NCT01976780|Drug|Artesunate|
16124449|NCT01976780|Drug|Artemether Lumefantrine|
16124450|NCT01976780|Drug|Mefloquine|
16125118|NCT01971424|Dietary Supplement|Mg oxide|
16124451|NCT01976754|Drug|Dexmedetomidine|Septic patients are randomly received 1 of 6 doses( 0.2,0.3,0.4,0.5,0.6,0.7μg/kg/h) dexmedetomidine.
16124452|NCT01976741|Drug|Rogaratinib (BAY1163877) oral solution|Participants received Rogaratinib oral solution as a single dose on Cycle 1 Day 1 (C1D1) and twice daily (BID) from Cycle 1 Day 3 (C1D3) onward for the remaining 19 days of Cycle 1. For subsequent cycles, study drug was administered twice daily for 21 days each Cycle.
16124453|NCT01976741|Drug|Rogaratinib (BAY1163877) oral tablet|Participants received Rogaratinib oral tablet as a single dose on C1D1 and BID from C1D3 onward for the remaining 19 days of Cycle 1. For subsequent cycles, study drug was administered twice daily for 21 days each Cycle.
16124454|NCT01976741|Drug|Rogaratinib (BAY1163877) 800 mg BID|Participants received Rogaratinib 800 mg oral tablet as a single dose on C1D1 and BID (in total 1600 mg) from C1D3 onward for the remaining 19 days of Cycle 1. For subsequent cycles, study drug was administered twice daily for 21 days each Cycle.
16124455|NCT01976728|Drug|Gonadorelin acetate subcutaneous (SC) 10 μg/pulse as a fixed dose, administered via. OmniPod pump|
16124456|NCT01976728|Drug|Gonadorelin acetate SC 15 μg/pulse as a fixed dose, administered via. OmniPod pump|
16124457|NCT01976728|Drug|Gonadorelin acetate SC 20 μg/pulse as a fixed dose, administered via. OmniPod pump|
16124458|NCT01976728|Drug|Placebo (SC 10, 15, or 20 μg/pulse as a fixed dose, administered via. OmniPod pump)|
16124459|NCT01976702|Behavioral|Enhanced Behavioral Skills Training|
16124460|NCT01976676|Dietary Supplement|5-methyltetrahydrofolate|
16124461|NCT01976676|Dietary Supplement|folic Acid|
16124462|NCT01976663|Device|JUVEDERM VOLIFT® XC|Up to 4 mLs JUVEDERM VOLIFT® XC injected intradermally in one NLF (total; including initial and touch-up treatments) and up to 4 mLs JUVEDERM VOLIFT XC is allowed for repeat treatment. For asymmetric correction, only the more severe NLF is eligible for asymmetric correction.
16124463|NCT01976663|Device|Control|Up to 4 mLs Control injected intradermally in opposite NLF (total; including initial and touch-up treatments). Up to 4 mLs JUVEDERM VOLIFT XC is allowed for asymmetry correction and up to 4 mLs JUVEDERM VOLIFT XC is allowed for repeat treatment. Only the more severe NLF is eligible for asymmetric correction.
16124464|NCT01976650|Drug|dexamethasone 700 ㎍ intravitreal implant|dexamethasone 700 ㎍ (OZURDEX®) intravitreal implant treatment for Branch Retinal Vein Occlusion, Central Retinal Vein Occlusion, or non-infectious uveitis affecting the posterior segment of the eye as per local standard of care in clinical practice.
16124465|NCT01976637|Other|no compression|no compression stockings worn during the study
16124466|NCT01976637|Device|compression|compression stockings class II (23-32 mm Hg) worn during the day for up to 3 weeks
16124467|NCT01976624|Drug|bimatoprost/timolol|Bimatoprost/timolol (Ganfort®) treatment for open-angle glaucoma or ocular hypertension as per local standard of care in clinical practice.
16124468|NCT01976611|Biological|botulinum toxin Type A|Botulinum toxin Type A treatment for chronic migraine as per local standard of care in clinical practice.
16124469|NCT01976598|Other|Sub-Sensory Stimulation|Sub-Sensory Stimulation using Boston Scientific Spinal Cord Stimulation System in patients currently implanted with the system .
16124470|NCT01976585|Drug|rhuFlt3L/CDX-301|"rhuFlt3L/CDX-301 is a truncated, soluble, recombinant human fms-like tyrosine kinase-3 ligand (Flt3L), expressed in a Chinese hamster ovary cell.
~RhuFlt3L/CDX-301 is formulated as a sterile solution intended for single-use parenteral administration. Each vial contains 2.5 mg/mL rhuFlt3L/CDX-301 in a 1 mL of buffered solution composed of Sodium Phosphate and Sodium Chloride, with a pH of 7."
16124471|NCT01976585|Drug|Poly-ICLC|Poly-ICLC is supplied by Oncovir in single-dose vials containing 1 mL of 2 mg/mL opalescent white suspension. Each milliliter of Poly-ICLC for injection contains 2 mg/mL poly-IC, 1.5 mg/mL poly-L-lysine, and 5 mg/mL sodium carboxymethylcellulose in 0.9% sodium chloride solution and adjusted to pH 7.6-7.8 with sodium hydroxide.
16124472|NCT01976572|Drug|colestilan|
16124473|NCT01976572|Drug|candesartan|
16124474|NCT01976559|Device|Tympanic Membrane Displacement (TMD)|"The CCFP Analyser has a passive mode and an active mode. When used in active mode, the device generates a tone burst that is transmitted to the ear to elicit contraction of the stapedius muscle. The passive mode requires no stimulus or sound burst.
~For each ICP level during the CSF infusion testing, the active mode will be used. Each condition comprises 13 stimuli of 0.3s duration."
16124475|NCT01976559|Device|DPOAE|DPOAE measurement uses a clinical acoustic probe to record the ear's response to two simultaneous tones. DPOAE measurements will be made for 13 tones. The total measurement time for each condition is 2-4 minutes.
16124476|NCT01976546|Device|Intubation with mcgrath videolaryngoscope and Boedeker intubation foreceps|Patients will be intubated with the Mcgrath videolaryngoscope and a tracheal tube placed by Boedeker intubation foreceps
16124477|NCT01976520|Biological|Oncoquest-CLL vaccine|Comparison of 4 different dose levels of Oncoquest-CLL vaccine: 100 micrograms (mcg)/0.2 milliliters (mL), 200 mcg/0.4 mL, 375 mcg/0.75 mL, and 500 mcg/mL. Patients will receive a total of 5 doses of vaccines; the first 2 doses separated by 2 week intervals and the last 3 doses by 1 month intervals. Vaccine will be given by sc injections in 2 sites in upper arms or legs.
16124478|NCT01976507|Drug|dabigatran etexilate mesylate|Immediately following the ablation procedure (4-6 hours after sheath pull and vascular hemostasis), dabigatran etexilate 150mg bid, or 75mg twice daily based on creatinine clearance in the Use in Specified Populations (USPI), will be administered for a minimum of 3 months post RF ablation.
16124479|NCT01976494|Device|The domestic PCA equipment 'Accufuser Omnibus®'|"Subject patient selection: the purpose and method of this research will be explained to the patients who satisfy the exclusion criteria before surgery, and written consent regarding research participation will be obtained.
~Use of PCA equipment by patients is determined by randomization. Regardless of the PCA equipment type, the basal rate and bolus dose are equally set to 2 mL/hr and 2 mL for the entire research period.
~Epidural PCA regime: normal saline added to 0.75% ropivacaine 40 mL and fentanyl 15-20 mcg/kg for a total volume of 100 ml.
~After pretreatment, the chest epidural catheter is mounted in the pretreatment room or operating room. The catheter tip is adjusted to be fixed between T6-7 or T7-8.
~After mounting the catheter, a test dose of 1% lidocaine 3 ml and epinephrine 1:200.000 is injected. Ten minutes later, sensory loss and skin dermatome will be checked using an alcohol swab."
16124530|NCT01976078|Drug|Midazolam/Ranitidine/Esomeprazole|Each of the three drugs will be given at 10% of their usual doses for age/weight.
16124807|NCT01973816|Drug|Cyproterone acetate 50 mg; estradiol 0.5% percutaneous|Daily intake for 18 months
16124480|NCT01976494|Device|Imported PCA equipment 'Infusor SV®, Baxter, USA'|"Subject patient selection: the purpose and method of this research will be explained to the patients who satisfy the exclusion criteria before surgery, and written consent regarding research participation will be obtained.
~Use of PCA equipment by patients is determined by randomization. Regardless of the PCA equipment type, the basal rate and bolus dose are equally set to 2 mL/hr and 2 mL for the entire research period.
~Epidural PCA regime: normal saline added to 0.75% ropivacaine 40 mL and fentanyl 15-20 mcg/kg for a total volume of 100 ml.
~After pretreatment, the chest epidural catheter is mounted in the pretreatment room or operating room. The catheter tip is adjusted to be fixed between T6-7 or T7-8.
~After mounting the catheter, a test dose of 1% lidocaine 3 ml and epinephrine 1:200.000 is injected. Ten minutes later, sensory loss and skin dermatome will be checked using an alcohol swab."
16124481|NCT01976481|Device|sunbed exposure|exposure to sunbed ultraviolet radiation
16124482|NCT01976468|Other|SCC metastasis|occurrence of SCC metastasis
16124483|NCT01976455|Other|20% fewer calories|
16124484|NCT01976455|Other|40% fewer calories|
16124485|NCT01976429|Other|flight/diving simulation|measurement of ET function during simulated flight/diving in pressure chamber
16124486|NCT01976429|Other|ET function testing at ambient pressure|ET function testing at ambient pressure using sonometry, tubomonometry, 9-step test, maneuver sequence
16124487|NCT01976429|Other|nasal video-endoscopy|examination of nose, nasopharynx,and Eustachian tube orifice
16124488|NCT01976416|Drug|Hydroxyurea|
16124489|NCT01976416|Drug|Placebo|
16124490|NCT01976403|Behavioral|Pain Booklet|The Pain Relief After Cardiac Surgery is originally a Canadian booklet. The booklet is further developed and modified for Norwegian patients
16124491|NCT01976390|Drug|Everolimus|0.75mg twice a day, Orally, starting on day of transplant
16124492|NCT01976390|Drug|Sirolimus|5mg, Orally, starting on day of transplant; decreasing to 3mg
16124493|NCT01976364|Drug|Tofacitinib|Tofacitinib 5 mg tablet twice daily
16124494|NCT01976364|Drug|Tofacitinib|Tofactinib 10 mg tablet twice daily
16124495|NCT01976364|Drug|Methotrexate|Methotrexate 7.5-20 mg weekly
16124496|NCT01976364|Drug|Placebo Methotrexate|Placebo to match active methotrexate orally once a week
16124497|NCT01976338|Drug|Ranibizumab 0.5 mg|intravitreal injection of 0.05 ml
16124498|NCT01976338|Other|Sham injection|Sham intravitreal injection
16124499|NCT01976325|Other|Ottawa Malaria Decision Aid|The Ottawa Malaria Decision Aid is a tool that helps patients become involved in decision making about which malaria prophylaxis pill is right for them to take. The decision aid provides information about the options for malaria chemoprophylaxis, information about the financial costs and time required to adhere to the course of preventative medication, and clarifies personal values. The decision aid is designed to complement counseling from a health practitioner.
16124500|NCT01976312|Other|Sham injection|Sham injections referred to the imitation of an intravitreal injection using an injection syringe without needle.
16124501|NCT01976312|Drug|Ranibizumab 0.5 mg|Ranibizumab solution for injection was supplied in vials. Each vial contained ranibizumab concentration of 10mg/mL labeled as 0.5 mg/0.5 mL, corresponding to a 0.5 mg dose level. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial for single use only
16124502|NCT01976299|Device|AVERT|
16124503|NCT01976286|Other|Salicylic Acid Peels|
16124504|NCT01976286|Other|Glycolic Acid Peels|
16124505|NCT01976273|Device|1064nm Q-switch Laser|
16124506|NCT01976273|Other|Glycolic Acid Peels|
16124507|NCT01976260|Device|Fractional Radiofrequency|
16124508|NCT01976260|Device|1550-nm Fractional Photothermolysis|
16124509|NCT01976247|Device|High Intensity Focused Ultrasound Device|
16124510|NCT01976247|Device|Noninvasive Cryolipolysis Device|
16124511|NCT01976234|Other|Fresh RBC|Patients will receive fresh blood only
16124512|NCT01976234|Other|Old RBC|
16124513|NCT01976208|Drug|Omalizumab|The recommended dose is 0.016mg/kg/IgE(IU/ml) every 4 weeks. It is administered by subcutaneous injection.If the total dose per 4 weeks is 150~300mg, the dosing interval will be every 4 weeks; if the total dose per 4 weeks is 450mg~750mg，then dosing interval is every 2 weeks.
16124514|NCT01976208|Drug|placebo|
16124515|NCT01976195|Drug|Dexamethasone|Dexamethasone 40 mg per day, 4 consecutive days
16124516|NCT01976195|Drug|Thalidomide|Thalidomide 150mg per day, 15 consecutive days
16124517|NCT01976182|Drug|Methotrexate|methotrexate 10mg / m² orally once a week, (at split doses of 5 mg/m2 in the morning and 5 mg/m2 at night), that is to say 2 tablets of 2.5 mg at each take, during 4 months.
16124518|NCT01976182|Drug|Cyclophosphamide|cyclophosphamide 100 mg orally once daily, that is to say 2 tablets of 50 mg at each take, during 4 months.
16124519|NCT01976169|Drug|PD-0332991 and T-DM1|"The subjects will be administered T-DM1 by intravenous infusion at 3.6 mg/kg for 90 minutes on day 1 of each 21 day cycle. Infusion timing may vary from 30-90 minutes depending on how well the subject tolerates the treatment.
~A standard 3+3 trial design will be used for PD-0332991 dose escalation cohorts.The dosing of PD-0332991 will be divided into 3 cohorts, the subjects will receive PD-0332991 on days 5-18 of each 21 day cycle.
~Cohort 1 : PD-0332991 - 100 mg daily (oral) Cohort 2 : PD-0332991 - 150 mg daily (oral) Cohort 3 : PD-0332991 - 200 mg daily (oral)"
16124520|NCT01976156|Dietary Supplement|PhosphoLean|PhosphoLean supplied by Cheminutra (White Bear Lake, MN). PhosphoLean® N-Oleoyl-PE + EGCG (NOPE + EGCG) is a proprietary phosphobioflavonic complex of N-oleoyl-phosphatidyl-ethanolamine (NOPE), which contains oleoyl ethanolamine (OEA) bound to phosphatidylethanolamine (PE), and epigallocatechin gallate (EGCG).
16124521|NCT01976156|Dietary Supplement|Placebo|Placebo consists of rice flour
16124522|NCT01976143|Drug|NKTR-102|
16124523|NCT01976130|Procedure|Bronchoscopy|
16124524|NCT01976117|Device|enose|
16124525|NCT01976104|Drug|avatrombopag (lower baseline platelet count)|60 mg avatrombopag (3 x 20 mg tablets)
16124526|NCT01976104|Drug|placebo (lower baseline platelet count)|60 mg placebo (3 x 20 mg matching placebo tablets)
16124527|NCT01976104|Drug|avatrombopag (higher baseline platelet count)|40 mg avatrombopag (2 x 20 mg tablets)
16124528|NCT01976104|Drug|placebo (higher baseline platelet count)|40 mg placebo (2 x 20 mg matching placebo tablets)
16124529|NCT01976091|Drug|scAAVrh74.tMCK.hSGCA|
16124531|NCT01976065|Drug|Triple Antibiotic Paste|USP antibiotic drugs mixed at a 1:1:1 ratio into a powder that is mixed with sterile saline to a paste-like consistency
16124532|NCT01976065|Other|Standard Treatment|Standard Treatment no use of study drug
16124533|NCT01976039|Other|rhinopharyngeal retrograde clearance (RRC)|The rhinopharyngeal retrograde clearance is a respiratory physical therapy technique that uses a forced inspiratory maneuver to clear the nasopharynx with the aid of saline instillation
16124534|NCT01976026|Device|Flow Diversion|
16124535|NCT01976026|Device|Best Standard Therapy|
16124536|NCT01976013|Device|Coaguchek|The investigators plan to draw 10μL blood (i.e. approximately 1/5000 of the blood volume of an ELBW infant) within the scope of routine blood sampling. Thus, the number of blood samples will be variable. A cumulative sample volume for the whole study period will not exceed 300μL.
16124537|NCT01976000|Procedure|multi-slice Computed Tomography angiography and three-dimensional reconstruction software|
16124538|NCT01975987|Device|Bonfils fiberscope|
16124539|NCT01975974|Device|Ultrasound|Using ultrasound as a guide for peripheral venous cannulation in obese patients
16124540|NCT01975961|Drug|Crestor 20mg(Rosuvastatin 20mg), Micardis 80mg(Telmisartan 80mg) , FDC|For co-administration, Crestor 1 tablet and Micardis 1 tablet. For FDC administration, FDC 1 tablet.
16124541|NCT01975948|Other|Mental Health Practice Support Program|"training and (2) practice support.
~Three half day workshop sessions over a 24 week period.
~Practice support:
~3 evidence based Supported Self Management tools (Cognitive Behavioral Interpersonal Skills Manual,Bounceback program, Antidepressant Skills Workbook), and Practice support coordinator provides guidance to incorporate newly acquired tools, skills, and processes"
16124542|NCT01975948|Other|Treatment as Usual|Physicians manage patients with depression as usual
16124543|NCT01975935|Drug|Amlexanox|25 mg amlexanox tablets blinded by encapsulation
16124544|NCT01975935|Drug|Placebo|placebo sham blinded by encapsulation in the same capsules as the study drug arm
16124545|NCT01975922|Behavioral|Enhanced Milieu Teaching|Enhanced Milieu Teaching (EMT) is a conversation-based model of early language intervention that uses child interest and initiations as opportunities to model and prompt language use in everyday contexts.
16124546|NCT01975909|Device|Transcranial Magnetic Stimulation|0.2 Hz (5 pulses every six seconds in a counter-clockwise current, followed by the same five pulses in a clockwise current); 10 pulses per region, 30 pulses per session; 5 days a week for 4 weeks.
16124547|NCT01975896|Behavioral|Meditation|The intervention's curriculum will include: 1) the body scan; 2) training in the awareness of the sensations of breathing; 3) training in directing the attention to simple activities of daily life; 4) practice of 'open awareness' in which students will be instructed to just notice which events (physical sensation, sound, visual object, thought) their attention is spontaneously drawn to from moment to moment; 5) mindful movement (standing and walking exercises); and 6) mindful eating. In addition to the weekly training session, students will practice mindfulness techniques for 15 minutes daily in class with the health education teacher and for an additional 15 minutes daily on their own
16124548|NCT01975870|Other|Application on smartphone|innovative application on smartphone which helps to increase the awareness of sedentary behavior of the user by messages, scoring system, ...
16124549|NCT01975857|Behavioral|Mind-Body Bridging Program|Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.
16124550|NCT01975857|Behavioral|Supportive Education|This intervention will provide educational lectures on disability, sleep hygiene, and current research on depression and nondirective, supportive discussions about these topics.
16124551|NCT01975844|Other|Individualized Anemia Mangement Protocol|"Phase 1 (1-3 months): Develop individualized patient models and Anemia Management Protocols (AMP) while patients are receiving standard medical care.
~Phase 2 (9 months): Individualized AMP study period. Phase 3 (9 months): Follow up period: return to standard-care AMP ."
16124552|NCT01975831|Drug|Durvalumab|Durvalumab was administered as an intravenous (IV) infusion over 60 (± 5) minutes.
16124553|NCT01975831|Drug|Tremelimumab|Tremelimumab was administered as an intravenous (IV) infusion over 60 (± 5) minutes.
16124554|NCT01975818|Drug|Molidustat (BAY 85-3934)|Oral doses of BAY85-3934 will be available in multiples of 25,50,75 and 150 mg tablets
16124555|NCT01975818|Biological|Epoetin alfa/beta|
16124556|NCT01975805|Other|Chlorhexidine Gluconate|
16124557|NCT01975805|Other|Povidone Iodine|
16124558|NCT01975779|Drug|Cohort A1: Lu AE58054 or placebo|One single oral dose 60 mg (one 60 mg tablet) followed by 60 mg once daily for 7 days, or matching placebo.
16124559|NCT01975779|Drug|Cohort A2: Lu AE58054 or placebo|One single oral dose 120 mg (two 60 mg tablets) followed by 120 mg once daily for 7 days, or matching placebo.
16124560|NCT01975779|Drug|Cohort B1: Lu AE58054|Two single oral doses 60 mg with >=7 days washout.
16124561|NCT01975766|Dietary Supplement|Ketogenic diet|A ketogenic diet matching the fat to carbohydrate + proteins in Keto-Cal(R) 4:1 by Nutricia North America.
16124562|NCT01975766|Device|External beam radiation therapy|
16124563|NCT01975753|Drug|Morphine|
16124564|NCT01975753|Drug|Fentanyl|
16124565|NCT01975740|Other|Sham manual diaphragm release technique|
16124566|NCT01975740|Other|The manual diaphragm release technique|To perform the technique the volunteer was placed in supine position with limbs relaxed. Positioned behind the head of the volunteer, the therapist performed manual contact (pisiform, ulnar edge and the last three fingers) with the underside of the costal cartilage of the 7th, 8th, 9th and 10th rib, and guiding forearms toward the shoulders of the corresponding side. In the inspiratory phase, the therapist gently pulled the points of contact with both hands, in the direction of the head, yet slightly lateral, accompanying the elevation movement of the ribs. During exhalation, the therapist deepened contact toward the inner costal, maintaining resistance throughout the inspiratory phase. In the breaths following, the therapist sought to gain traction and smooth increase in the deepening of contacts. This maneuver was performed in two sets of ten deep breaths, with a one minute interval between them.
16124567|NCT01975727|Drug|Placebo|Injection of placebo (saline 0.9%)
16124568|NCT01975727|Drug|Dexamethasone 3 mg|10 ml Seringue with Dexamethasone
16124569|NCT01975727|Drug|Dexamethasone 6 mg|10 ml Seringue with Dexamethasone
16124570|NCT01975727|Drug|Dexamethasone 12 mg|10 ml Seringue with Dexamethasone
16124571|NCT01975714|Drug|Preservative-free latanoprost|
16124574|NCT01975688|Drug|Sativex|"Oromucosal spray containing THC (27 mg/mL) and CBD (25 mg/mL) in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring.
~Each vial contains 10 mL; each 100 uL actuation delivers 2.7 mg THC and 2.5 mg CBD."
16124575|NCT01975675|Drug|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered orally once daily
16124576|NCT01975675|Drug|RBV|RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (≤ 60 kg = 600 mg, > 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)
16124577|NCT01975662|Drug|Daptomycin|Duration of treatment will be determined based on the type of bacteremia. Patients with uncomplicated bacteremia will receive a minimum of 14 days antibiotics and those with complicated bacteremia or infective endocarditis will receive a minimum of 28 to 42 days antibiotics from the date that microbiological clearance is achieved.
16124578|NCT01975662|Drug|Vancomycin|Duration of treatment will be determined based on the type of bacteremia. Patients with uncomplicated bacteremia will receive a minimum of 14 days antibiotics and those with complicated bacteremia or infective endocarditis will receive a minimum of 28 to 42 days antibiotics from the date that microbiological clearance is achieved.
16124579|NCT01975649|Drug|Tribulus Terrestris|patients will use 750 mg/day during 120 days
16124580|NCT01975649|Other|Placebo|patients will use placebo pills with the same shape of the drug
16124581|NCT01975636|Drug|E2609|Single oral 100 mg +/- 10 mg E2609 with a level of radioactive exposure consistent with the Radioactive Drug Research Committee allowance
16124582|NCT01975623|Device|HARMONIC ACE®+ Shears (HS)|We plan to evaluate the efficacy of the HS for the sealing of PAs in an ex-vivo human model. Efficacy will be measured and compared using the bursting pressure point following vascular energy sealing. Energy sealing may be superior to stapling devices as it eliminates the need for excessive tissue dissection around the pulmonary vessels, which in turn decrease the incidence of vascular injuries during VATS anatomical lung resection. All vessels will be sealed ex-vivo using the HARMONIC ACE®+ Shears (Ethicon, Cincinnati, Ohio, USA).
16124583|NCT01975610|Drug|CC-292|375 mg PO daily (250 mg in the AM and 125 mg in the PM for 28 days)
16124584|NCT01975610|Drug|Placebo|Twice daily for 28 days
16124585|NCT01975597|Procedure|Bone marrow aspirates and biopsy|
16124586|NCT01975584|Behavioral|Trier Social Stress Test|Participants will participate in a standardized role play (Trier Social Stress Test ). A role play is pretending to be in a certain situation. A research staff member will describe the role play, during which teh participant will act out a scene. Participants will be asked to imagine that they are in a certain role with several other research team members who will also participate in the role play. Participants will also be asked to do some math problems without using paper or pencil.
16124587|NCT01975571|Device|Cochlear® Nucleus™ Hybrid L24|The Nucleus Hybrid L24 cochlear implant incorporates an electrode array designed to preserve residual hearing. This has been accomplished by employing a thin, straight, intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The Nucleus Hybrid L24 array has 22 electrodes spread over 16 mm and an anticipated insertion depth of 16 mm. It is slim, with its dimensions ranging from 0.35 x 0.25 mm (at the tip) to 0.55 x 0.4 mm, and designed to minimize lateral wall forces with a stiffened basal section to prevent buckling. The resultant insertion angle is about 280-300° in the scala tympani for the Hybrid L24, as confirmed in temporal bone trials at the Medical University Hannover and the University of Melbourne.
16124588|NCT01975571|Device|Cochlear® Nucleus™ Hybrid S12|The Nucleus Hybrid S12 cochlear implant incorporates an electrode array designed to stimulate the high-frequency, basal region of the cochlea while maintaining useful acoustic hearing in the low-frequency, apical region. This has been accomplished by employing a short, thin, straight intracochlear electrode array attached to a Nucleus cochlear implant receiver/stimulator. The electrode array incorporates a collar to prevent over-insertion, or further migration, into the cochlea beyond the point where the basal turn curves into the ascending segment. Thus, the electrode array is placed within the straight segment of the basal turn of the scala tympani via a cochleostomy.
16124589|NCT01975558|Biological|Sampling at baseline, one week after baseline, two weeks after baseline|
16124590|NCT01975558|Biological|Sampling at baseline, during radiotherapy and after|
16124591|NCT01975545|Drug|Fluor varnish|Dental varnish will be applied to one anterior superior teeth in a random side.
16124592|NCT01975545|Drug|Fluor varnish with nanoparticles|Dental varnish with silver nanoparticles will be applied to one anterior superior teeth in a random side.
16124593|NCT01975519|Drug|TRC105 and Pazopanib|Weekly TRC105 in combination with standard dose Pazopanib.
16124594|NCT01975480|Drug|Desvenlafaxine|
16124595|NCT01975467|Device|CRx|The CRx is used to treat mid-shaft, with or without comminution clavicle fractures.
16124596|NCT01975454|Drug|Chemotherapy|Oxaliplatin (130 mg/m2) was given intravenously (iv) for at least 2 h on day 1; Capecitabine (1000 mg/m2) was given orally, twice daily on days 1-14. Each cycle was 21 days. Cycles were repeated until disease progression or unacceptable toxicity.
16124597|NCT01975454|Drug|Herbal therapy|TLBZT based herbal decoction administered orally twice a day
16124598|NCT01975441|Drug|Diethylcarbamazine|Diethylcarbamazine 6mg/kg
16124599|NCT01975441|Drug|Albendazole|Albendazole 400mg
16124600|NCT01975441|Drug|Ivermectin|Ivermectin 200 mcg/kg
16124601|NCT01975428|Device|DM Pgm + device|"Disease management program plus a device corresponding to an individual's disease(s):
~iBGStar - iPhone enabled capillary blood glucose meter. Subjects test blood glucose up to 4 times per day, every day.
~Withings BP monitor - iPhone enabled home blood pressure monitor. Subjects test their blood pressure 2 times per day, up to 3 days per week.
~iPhone enabled Alive Cor ECG monitor. Participants take an ECG reading only when symptomatic."
16124602|NCT01975428|Behavioral|Control|All study participants, including participants randomized to the control arm, were enrolled in the HealthComp disease management program, which involved outreach by HealthComp nursing staff for purposes of relaying medical education and wellness information with regard to disease prevention and chronic disease management.
16124603|NCT01975389|Drug|bococizumab (PF-04950615)|150 mg, every 2 weeks, subcutaneous. The duration of the treatment period will depend upon reaching the targeted number of adjudicated and confirmed CV outcome events, approximately 3 to 4 years after the entry of first subject into the study.
16124639|NCT01975220|Drug|Empagliflozin/Metformin XR, FDC|Experimental: high dose empagliflozin/metformin XR, FDC tablet
16125119|NCT01971424|Other|healthy diet|
16124604|NCT01975389|Drug|Placebo|Placebo comparator, every 2 weeks, subcutaneous. The duration of the treatment period will depend upon reaching the targeted number of adjudicated and confirmed CV outcome events, approximately 3 to 4 years after the entry of first subject into the study.
16124605|NCT01975376|Drug|bococizumab (PF-04950615)|150 mg, every 2 weeks, subcutaneous. The duration of the treatment period will depend upon reaching the targeted number of adjudicated and confirmed CV outcome events, approximately 3 to 4 years after the entry of first subject into the study.
16124606|NCT01975376|Drug|Placebo|Placebo comparator, every 2 weeks, subcutaneous. The duration of the treatment period will depend upon reaching the targeted number of adjudicated and confirmed CV outcome events, approximately 3 to 4 years after the entry of first subject into the study.
16124607|NCT01975363|Dietary Supplement|curcumin|Participants will be randomized to either 50 mg BID or 100 mg BID NEC for a 3 month treatment period.
16124608|NCT01975363|Other|Biomarker analysis|Breast adipose tissue and plasma samples will be obtained at baseline and 3 months for biomarker analyses. Breast adipose tissue samples will be obtained via fine needle aspiration. Plasma samples from the baseline blood draw will be assessed for curcumin/COG and also stored at -80°C for biomarker analyses.
16124609|NCT01975363|Other|Assessment of Dietary Intake|Food frequency questionnaires will be obtained at 0 months and 24-hour dietary recalls will be obtained at 1, 2 and 3 months of the study.
16124610|NCT01975363|Other|Daily Log|All participants will complete a daily log on the date and time of NEC administration, potential adverse events, and medications.
16124611|NCT01975337|Drug|Alisporivir|Alisporivir supplied as 200 mg oral capsules in blister packs (7 units per blister pack)
16124612|NCT01975324|Drug|dalfampridine|dalfampridine 10 mgs or placebo twice a day for two weeks, wash out period of two weeks, dalfampridine 10mgs or placebo twice a day for two weeks
16124613|NCT01975324|Drug|Placebo|placebo (sugar pill) twice a day for two weeks
16124614|NCT01975311|Other|Lumbopelvic Manipulation|High-velocity low-amplitude non-specific lumbopelvic thrust manipulation
16124615|NCT01975311|Other|Passive lumbar spine flexion and extension|Passive lumbar spine flexion and extension without reaching the physiological end feel for 1 min from a side lying position.
16124616|NCT01975298|Drug|Laquinimod|Oral Administration
16124617|NCT01975298|Drug|Avonex®|Interferon β1A 30 μg/0.5mL administered Intra Muscular
16124618|NCT01975285|Drug|Dexamethasone|0.5% Bupivacaine with 1:200,000 epinephrine + Dexamethasone 4mg per 20cc
16124619|NCT01975285|Drug|Saline|0.5% Bupivacaine with 1:200,000epinephrine + Saline 1 ml per 20cc
16124620|NCT01975272|Drug|Ferinject|
16124621|NCT01975272|Drug|Ferrous fumarate|
16124622|NCT01975272|Drug|Placebo for ferrous fumarate|
16124623|NCT01975272|Drug|Placebo for ferinject|
16124624|NCT01975259|Drug|Oral Glucose Tolerance test (75g 2-hour)|A standard 2-hour oral glucose tolerance test where fasted patients (10hours overnight) consume a 75g glucose solution & have glucose levels recorded up to every 30 mins for 2hours
16124625|NCT01975259|Drug|Modified Oral Glucose Tolerance Test (50g 4-hours)|A 4-hour version of the oral glucose tolerance test where fasted patients (10hours overnight) consume a 50g of glucose solution & have glucose levels recorded up to every 5mins as well pancreatic and incretin responses at 10 fixed time points.
16124626|NCT01975259|Drug|Matched isoglycemic clamp|A glucose drip will be infused at a variable rate that recreates the individual subjects blood glucose values obtained during their 4-hour modified oral glucose tolerance test. This test will therefore last 4-hours and again subjects will be fasted (10hours overnight) at the time of the test. The same blood tests will be performed at the same time points as the modified glucose tolerance test
16124627|NCT01975259|Drug|Hyperglycemic clamp with concurrent GLP-1 infusion|An intravenous glucose infusion will be infused at a rate that maintains blood glucose at a level of 180-216mg/dL (10-12 mmol/l) (hyperglycemic clamp). After 60mins an infusion of GLP-1 will be commenced at a rate of 0.25pmol/kg/min for 60mins and then continued at a rate of 1.2pmol/kg/min for a further 60mins. Subjects will be blinded to what infusion they are receiving.
16124628|NCT01975259|Drug|Hyperglycemic Clamp with concurrent GIP infusion|An intravenous glucose infusion will be infused at a rate that maintains blood glucose at a level of 180-216mg/dL (10-12 mmol/l) (hyperglycemic clamp). After 60mins an infusion of GIP will be commenced at a rate of 1pmol/kg/min for 60mins and then continued at a rate of 4pmol/kg/min for a further 60mins. Subjects will be blinded to what infusion they are receiving.
16124629|NCT01975259|Drug|Hyperglycemic clamp with placebo infusion|"An intravenous glucose infusion will be infused at a rate that maintains blood glucose at a level of 180-216mg/dL (10-12 mmol/l) (hyperglycemic clamp).
~After 60mins an infusion of normal saline will be commenced as a placebo infusion. It will be infused at a rate so that the total volume of fluid is similar to that infused during the other two hyperglycemic clamp interventions. Subjects will be blinded to what infusion they are receiving."
16124630|NCT01975259|Other|Liquid Meal Test (Carbohydrate-rich)|A standardised liquid meal (carbohydrate-rich) containing approximately 500kcal would be administered to patients who had fasted overnight (10hrs). Over the next 4hours bloods would be sampled at 10 fixed time points to measure features of the incretin response to this type of meal.
16124631|NCT01975259|Other|Liquid Meal Test (Fat-rich)|A standardised liquid meal (fat-rich) containing approximately 500kcal would be administered to patients who had fasted overnight (10hrs). Over the next 4hours bloods would be sampled at 10 fixed time points to measure features of the incretin response to this type of meal.
16124632|NCT01975259|Other|Liquid Meal Test (Mixed)|A standardised liquid meal (mixed) containing approximately 500kcal would be administered to patients who had fasted overnight (10hrs). Over the next 4hours bloods would be sampled at 10 fixed time points to measure features of the incretin response to this type of meal.
16124633|NCT01975259|Device|Continuous Glucose Monitoring|Continuous glucose monitoring entails wearing a small portable device, usually on the upper arm, for a period of three days. The device uses a small plastic tube to record the glucose level from interstitial fluid & every minute wirelessly transmits this information to a base unit to enable a very accurate estimate of average blood sugar control to be defined.
16124634|NCT01975246|Drug|Telmisartan + amlodipine|FDC tablet
16124635|NCT01975246|Drug|hydrochlorothiazide|tablet
16124636|NCT01975246|Drug|Telmisartan + amlodipine|FDC tablet
16124637|NCT01975246|Drug|Placebo|placebo matching hydrochlorothiazide tablet
16125154|NCT01971138|Other|this is a survey|
16124640|NCT01975220|Drug|Empagliflozin/Metformin XR FDC|Experimental: low dose empagliflozin/metformin XR, FDC tablet
16124641|NCT01975220|Drug|25 mg Empagliflozin/1000 mg Metformin XR, FDC|Experimental, high dose Empagliflozin/Metformin XR,FDC Tablet
16124642|NCT01975220|Drug|1 tablet Empagliflozin/2 tablets Metformin XR|Active Comparator: 1x empagliflozin/2x metformin XR tablets
16124643|NCT01975220|Drug|1 tablet Empagliflozin/3 tablets Metformin XR|Active Comparator: 1x empagliflozin/3x metformin XR tablets
16124644|NCT01975220|Drug|1 tablet Empagliflozin/2 tablets Metformin XR|Active Comparator: 1x empagliflozin/2x metformin XR tablets
16124645|NCT01975207|Behavioral|Treatment as usual|Participants will be treated as per clinic's standard treatment for depression.
16124646|NCT01975207|Behavioral|Internet Intervention|"One of the major treatments for mild-moderate depressive disorders is cognitive behavioural therapy (CBT). It has been possible to operationalize some of this treatment and internet-based approaches to this have been developed. The most widely examined was developed in Australia and is termed MoodGYM (https://moodgym.anu.edu.au/welcome). This program has been widely studied, and these studies have shown it is very effective for many individuals in family practice"
16124647|NCT01975207|Behavioral|Depression Treatment Pathway|"There has been a growing awareness in health care circles that certain high frequency, high cost addiction and mental health disorders may be best addressed via the systemic adoption of clinical pathways. A clinical pathway is defined as a multidisciplinary outline of anticipated care, placed in an appropriate timeframe, to help a patient with a specific condition or set of symptoms move progressively through a clinical experience to positive outcomes. A clinical pathway incorporates guidelines, protocols and evidence informed best practice into everyday use for the patient and family."
16124648|NCT01975194|Drug|Rosuvastatin|Patients will be started at 20 mg per day and then increased to 40 mg per day if not at target by six weeks
16124649|NCT01975168|Device|Handylaser Trion laser acupuncture|intervention interval is 3 times per week for 12 weeks
16124650|NCT01975155|Other|food questionnaire|
16124651|NCT01975155|Other|Urinary mycotoxin test|
16124652|NCT01975142|Drug|Trastuzumab - Emtansine|
16124653|NCT01975129|Drug|Vagitocin|
16124654|NCT01975116|Drug|azurin-derived cell-penetrating peptide p28|Given IV
16124655|NCT01975103|Procedure|Topcon Endpoint Management|
16124657|NCT01975077|Drug|fruquintinib|Fruquintinib is a capsule in the form of 1mg and 5mg, orally, daily
16124658|NCT01975064|Drug|Propofol|Propofol will be infused individually for a sufficient level of anesthesia during the entire surgical procedure.
16124659|NCT01975064|Drug|Sevoflurane|Sevoflurane will be administered by vaporizer individually for a sufficient level of anesthesia during the entire surgical procedure.
16124660|NCT01975051|Drug|Mitefosine|Tablet Miltefosine 100 mg in two devided doses for 12 weeks
16124661|NCT01975025|Procedure|Short daily dialysis for 2 weeks|
16124662|NCT01975012|Drug|Rilpivirine|"For Cohort 1, Stage 1: RPV will be given orally as a 25-mg film-coated tablet (or for dosing in younger children, as granules [2.5 mg/g]) each day with a meal.
~For Cohort 1, Stage 2: The dose of RPV will be determined once Cohort 1, Stage 1 data are available.
~For Cohort 2: The dose of RPV will be determined once Cohort 1 data are available."
16124663|NCT01974986|Other|Water with flavoring and non-nutritive sweetener.|A volume of fluid (water) was given after exercise to return each subject's body mass (to euhydration).
16124664|NCT01974986|Other|High-Na low-CHO beverage|A volume of fluid (high-Na, low-CHO) was given after exercise to return each subject's body mass (to euhydration).
16124665|NCT01974986|Other|Low-Na high-CHO beverage|A volume of fluid (low-Na, high-CHO) was given after exercise to return each subject's body mass (to euhydration).
16124666|NCT01974973|Procedure|Autologous bone marrow mononuclear cell transplantation|Intrathecal autologous bone marrow mononuclear cell transplantation
16124667|NCT01974947|Other|Blood sample, sperm sample and clinical examens|Blood sample, sperm sample and clinical examens will be done at the day of the inclusion
16124668|NCT01974934|Drug|Desvenlafaxine Succinate|
16124669|NCT01974921|Device|ALAIR Catheter. Radiofrequency system.|Radiofrequency with Alair Catheter trhough flexible bronchoscopy in three different sessions (right lower lobe, left lower lobe, both upper lobes).
16124670|NCT01974908|Procedure|Fibrillatory Factor calculation (FF)|During sinus rhythm these patients will undergo a simple pacing protocol to allow us to calculate FF, which is an area we would predict is mod likely to be the origin of their VT.
16124671|NCT01974895|Biological|FluLaval® Quadrivalent|1 or 2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm (for subjects ≥12 months of age) or anterolateral region of left thigh (for subjects <12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively.
16124672|NCT01974895|Biological|Fluzone®|1 or 2 doses administered IM in deltoid region of non-dominant arm (for subjects ≥12 months of age) or anterolateral region of left thigh (for subjects <12 months of age) on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects), respectively.
16124673|NCT01974882|Other|Ice pack|Cryotherapy was applied via reusable ice bags filled with ice. Ice packs were immediately applied after the dressing was placed on the wound. The ice pack maintained in place for a continuous 24 hours adn was refilled as needed. After twenty-four hours, patients had the option of using ice packs for as long as they wished. The duration of ice pack usage was noted.
16124674|NCT01974869|Drug|Anti-tumor necrosis factor alpha agents|Treatment with biologics
16124675|NCT01974843|Drug|Levobupivacaine|in the levobupivacaine-tramadol (LT) group received a caudal injection of levobupivacaine 0.25% plus tramadol 2 mg/kg (maximum doses; 35 mg levobupivacaine plus 35 mg tramadol), resulting in a total volume of 1 ml/kg at maximum volume of 15 ml
16124676|NCT01974843|Drug|Bupivacaine|in the bupivacaine-tramadol (BT) group received a caudal injection of bupivacaine 0.25% plus tramadol 2 mg/kg (maximum doses; 35 mg bupivacaine plus 35 mg tramadol)
16124677|NCT01974817|Biological|13-valent conjugate pneumococcal vaccine|0.5ml IM for one dose
16124678|NCT01974804|Procedure|MRI|
16125402|NCT01969578|Drug|Cisplatin + Doxorubicin|
16124679|NCT01974791|Behavioral|GET Living|GET Living is an exposure based treatment jointly delivered by a cognitive-behavioral therapist and physical therapy to help children and adolescents suffering with chronic pain and headache progressively return to valued life activities.
16124680|NCT01974778|Dietary Supplement|Meal|Meal
16124681|NCT01974765|Drug|Enzalutamide|All enrolled patients will be treated with enzalutamide 160mg by mouth QD. Study drugs will be self-administered by patients. A cycle is 28 days.
16124682|NCT01974752|Drug|75mg selumetinib|selumetinib tablets p.o. twice daily taken in combination with dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle.
16124683|NCT01974752|Drug|placebo|placebo tablets p.o. twice daily taken in combination with dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle.
16124684|NCT01974752|Drug|Dacarbazine|dacarbazine 1000mg/m2 iv on day 1 of every 21-day cycle taken in combination with either selumetinib or placebo tablets p.o. twice daily.
16124685|NCT01974739|Drug|Hydrochloorthiazide|
16124686|NCT01974739|Drug|placebo|
16124687|NCT01974726|Other|ET Stress test|Performed in pressure chamber. For subjects with intact tympanic membranes, chamber pressure increased from ambient to +2500 daPa (+2000 daPa for children). At that pressure and then at down-stepped pressures of 250 daPa/steps to a chamber pressure of -1500 daPa (or a passive ET opening), the subject will swallow to attempt to open the ET as detected by sonotubometry and/or a change in ear canal pressure. ET passive opening and closing pressures will then be determined. In ears with a non-intact tympanic membrane, a small volume probe connected to a pressure transducer will be placed in the ear canals and the procedure repeated with continuous recording of ME pressure. ET opening is recorded as a change in ME pressure toward local ambient.
16124688|NCT01974726|Other|Sonotubometry|Microphones are placed in the ear canals and covered with ear protectors. A nasal probe placed in one nostril introduces a white noise to the nasopharynx and the subject is asked to swallow. The test system identifies the sound frequency best transmitted through an open ET (if the test is positive, i.e. ET opens) and the procedure is repeated with the nasal sound pressure delivered at that frequency. The probe is then placed in the contralateral nostril and the procedure repeated. The microphone signals from both ear canals are continuously outputted and recorded. A positive ET opening is defined as a 5 dB increase above baseline during any of the 4 swallows and can be semi-quantified as the area under the baseline-adjusted ear canal sound pressure-time curve. The test is designed to measure the presence or absence of muscle-assisted ET openings during swallowing at local ambient pressure.
16124689|NCT01974726|Other|Forced Response Test (FRT)|The FRT requires a non-intact tympanic membrane and uses an instrument consisting of an ear canal probe coupled serially to a differential pressure transducer, via a valve to a flow sensor and via a second valve to a variable-speed constant-flow pump. The probe is sealed in the ear canal and both valves are opened. The pump is set to deliver a constant flow of 11 ml/min which increases ME pressure to passively open the ET. This is followed by a decrease in ME pressure to steady state pressure and flow conditions. The subject is asked to swallow which either transiently increases (further ET dilation) or decreases (ET constriction) the transET flow. The pump is turned off causing the ET to close at a residual ME pressure. This procedure is repeated at flow rates of 23 and then 46 ml/min.
16124690|NCT01974726|Other|Inflation Deflation Test (IDT)|The IDT requires a non-intact tympanic membrane and uses the FRT instrument. ME pressure is increased to 250 daPa (ref ambient), the valves to the flow sensor and pump closed and the subject is asked to swallow repeatedly at a natural interval while monitoring ME pressure until further swallowing fails to change ME pressure. The procedure is repeated with an applied under-pressure of -250 daPa. The outcome variable is the percent pressure change (%reduction) at test end. The test measures the muscle-assisted tubal openings under minor stress (ME under-pressure) and facilitative (ME over-pressure) conditions, and can detect a patulous/semi-patulous ET by an inability to maintain applied ME over and/or under-pressures between swallows.
16124691|NCT01974726|Other|Maneuver Sequence|The sequence consists of the Toynbee, Valsalva, Sniffing and Continuous Pressure Test (CPT). The test system consists of ear canal and nasal pressure probes. For the Toynbee test the subject pinches both nostrils (without constricting the nasal probe) and swallows; for the Sniffing test, the subject performs a series of forcible sniffs that must achieve a nasopharyngeal pressure of at least -400 daPa; for the Valsalva test the subject pinches both nostrils and forcibly blows against the closed nose to achieve a nasopharyngeal pressure of at least 400 daPa, and for the CPT the subject breathes through his/her mouth in a relaxed manner for 2 minutes.
16124692|NCT01974726|Other|9-Step Test|This test requires an intact tympanic membrane. Middle ear (ME) pressure is recorded by tympanometry before and after application of a 300 daPa over-pressure to the ear canal and then before and after application of a 300 daPa under-pressure to the ear canal. Between steps, the subject is asked to swallow in an attempt to open the ET and change ME pressure. A positive test is indicated by a minimum 10 daPa change in ME pressure after a given swallow and excellent muscle-assisted ET opening is indicated by an initial change to a more negative ME pressure after a swallow, followed by a return to 0 daPa, a positive ME pressure and a return to 0 daPa for sequential swallows. The test is designed to measure the presence/absence of active ET openings during swallowing at ambient pressures.
16124693|NCT01974726|Other|Tubomanometry|The test system is commercially available and can test ears with and without an intact tympanic membrane. Pressure sensors are inserted bilaterally into the ear canals and sealed. A controlled air-flow is introduced into the nose and nasopharynx and the subject swallows. ET openings are detected as a change in ME pressure measured directly as a pressure pulse in the ear canal for ears with a non-intact tympanic membrane or indirectly as a change in ear canal pressure caused by tympanic membrane displacement in ears with intact tympanic membranes. The outcome is the detection of a pressure change in the ear canal during swallowing which is indicative of a muscle-assisted tubal opening.
16124723|NCT01974505|Device|intubation using optiscope|Optiscope (Clarus Medical, Minneapolis, MN, USA) is a semi-rigid fiberscope designed for endotracheal intubation. Anesthetic providers who are novice on optiscope will perform intubation using optiscope.
16124724|NCT01974492|Procedure|Upper leg vein harvesting|Patients whose saphenous veins are harvested from upper legs.
16124725|NCT01974492|Procedure|Lower leg vein harvesting|Patients whose saphenous veins are harvested from lower legs.
16124808|NCT01973816|Drug|Estradiol 0.5% percutaneous gel; Cyproterone acetate 50 mg oral|Daily intake during 24 months
16124809|NCT01973790|Drug|Z-338|100mg TID
16124810|NCT01973777|Device|IUB|intrauterine contraceptive device
16124694|NCT01974726|Other|Videoendoscopic assessment of ETF|The subject's nose is topically anesthetized and decongested with 4% lidocaine and 0.05% oxymetazoline. If ventilation tubes are present, probes are sealed in the ear canal(s)and a pressure of 200 daPa is applied to the ME(s) to assess ET opening. If tympanic membranes are intact, microphones for sonotubometry are placed in the ear canals. Then, an endoscope attached to a video camera is introduced into the ipsilateral nasal cavity and focused on the ET orifice. For sonotubometry, the sound source probe is placed in the contralateral nostril. The subject is asked to swallow, vocalize and perform a series of mandibular movements. Signals from the video camera and pressure transducer or sonotubometry microphones are continuously recorded. The data are studied to document dilation of the nasopharyngeal ET orifice during swallowing and to rule in or out an anatomical or functional nasopharyngeal abnormality as the cause of a diagnosed ET dysfunction.
16124695|NCT01974726|Other|Pressure chamber ET test|Performed in pressure chamber. Pressure increased to create middle-ear underpressure, then subject is asked to swallow several times. Middle-ear pressures are then measured by tympanometry. This is repeated with decreased chamber pressure, creating a middle-ear overpressure.
16124696|NCT01974700|Drug|Levetiracetam|500 mg intravenous dose during the operative case then 500 mg orally twice a day for a total of seven days
16124697|NCT01974687|Drug|Uprifosbuvir|Uprifosbuvir 5 mg, 25 mg, or 50 mg capsule, or 150 mg tablet, administered by mouth.
16124698|NCT01974687|Drug|Placebo|Matching placebo to uprifosbuvir capsule administered by mouth.
16124699|NCT01974687|Drug|Itraconazole|Itraconazole is supplied as 10 mg/mL oral solution or 100 mg capsules administered by mouth.
16124700|NCT01974674|Procedure|Allogeneic transplantation of intrahepatic islet|
16124701|NCT01974661|Biological|COMBIG-DC (ilixadencel)|Allogenic dendrite-cell based therapeutic vaccine
16124702|NCT01974648|Drug|propofol|
16124703|NCT01974648|Drug|propofol and remifentanil|
16124704|NCT01974635|Device|AMES Therapy|During the therapy session, the AMES device rotates the hand into flexion and extension, while the patient assists with this motion, as possible. At the same time, the AMES device provides sensory stimulation by vibrating the tendons of muscles stretched by the movement. The vibratory stimulus switches from one side of the limb to the other when the rotation reverses direction so that the sensory stimulation remains functionally related to the movement. The subject will receive visual bio-feedback of their contribution to the motor movement.
16124705|NCT01974622|Drug|Visudyne|Half fluence verteporfin
16124706|NCT01974609|Drug|Narcotic|Hydrocodone 5mg + acetaminophen 325 mg
16124707|NCT01974609|Drug|non-narcotic|ibuprofen 600mg + acetaminophen 325 mg
16124708|NCT01974596|Dietary Supplement|Probiotic tablets of Lactobacillus reuteri|
16124709|NCT01974596|Dietary Supplement|Placebo tablets|
16124710|NCT01974583|Procedure|regrafted with thin split-thickness skin graft|Group A (the treatment group) were regrafted with thin split-thickness skin graft
16124711|NCT01974583|Procedure|covered with the occlusive hydrocellular dressing|group B covered with the occlusive hydrocellular dressing (Allevyn Adhesive, Smith & Nephew)
16124712|NCT01974583|Procedure|covered with paraffin gauze|Group C covered with paraffin gauze
16124713|NCT01974570|Dietary Supplement|Marealis refined peptide concentrate|2 tablets, once per day before noon
16124714|NCT01974570|Dietary Supplement|Placebo|2 tablets, once per day before noon
16124715|NCT01974557|Other|Exercise|
16124716|NCT01974544|Drug|Best medical treatment|If patients are unable to maintain their haemoglobin A1c (HbA1c) values below 6.5% on diet alone, treatment with metformin 1g twice daily will be started. If HbA1c remains above 7.0% then liraglutide 0.6 mg once daily (with a subsequent increases to 1.2 mg and 1.8 mg once daily). If liraglutide is not tolerated then a Dipeptidyl peptidase IV inhibitor (sitagliptin, saxagliptin, linagliptin) or pioglitazone will be considered. If HbA1c remains above 7.5% long acting insulin analogues such as detemir o glargine will be added. If insulin is started liraglutide can be stopped. The insulin dose will be adjusted according to the morning fasting blood glucose concentration. Finally, Fast-acting meal time insulin (lispro, aspart or glulisine) will be added if glycemic goal is not achieved. Repaglinide can be considered in patients with significant renal impairment and in patients who refused insulin treatment.
16124717|NCT01974544|Procedure|gastric bypass|For the gastric bypass, the gastric pouch will be adjusted to a volume of 15-20 ml. The alimentary limb will be a standard 150 cm and the biliopancreatic limb 50 cm. A hand-sewn gastro-jejunal anastomosis will be performed over a 34 French bougie
16124718|NCT01974544|Procedure|sleeve gastrectomy|The sleeve gastrectomy will be done using laparoscopic staplers over a 34 French bougie.The greater curvature will be dissected 4 cm proximal to the pylorus leaving the antrum. Short gastric vessels will be dissected using the harmonic scalpel up to the gastro-esophageal junction. The stapler will be reinforced. The resected stomach will be removed in a plastic bag through the left flank trocar
16124719|NCT01974544|Drug|General interventions for all groups: blood presure|Patients will receive an angiotensin-converting-enzyme (ACE) inhibitor or angiotensin II receptor antagonists (ARA II) to meet strict blood pressure targets of the ADA / European Association for Study of Diabetes (EASD) or in the presence of micro or macroalbuminuria. In addition to ACE inhibitors (or if there were side-effects, an angiotensin-II receptor antagonist), calcium antagonist, diuretics or Beta blockers can be added as needed. Aspirin 100 mg daily will be used for secondary prevention in patients with a history of ischaemic cardiovascular disease.
16124720|NCT01974544|Drug|General interventions for all groups: dysilipidemia|Raised fasting serum cholesterol concentrations (greater than 4.5 mmol/L) or combined dyslipidaemias will be treated with atorvastatin 10-80mg once daily. Gemfibrozilo or fenofibrate once daily can be used for isolated hypertriglyceridaemia (fasting serum triglyceride concentration >4.0 mmol/L), or fenofibrate can be added to statin treatment if the fasting serum triglyceride concentration was also raised (>4.0 mmol/L).
16124721|NCT01974544|Behavioral|General interventions for all groups: lifestyle|Exercise is an important part of the diabetes management plan. The ADA recommendations for the adults with diabetes is at least 150 min/week of moderate-intensity aerobic physical activity (50-70% of maximum heart rate), with no more than two consecutive days without exercise. A kinesiologist will design an individual plan of physical training for each patient. Also, a nutritionist will be design an individual dietitian plan, this plan should be formulated as a collaborative therapeutic alliance among the patient and family, physician, and other members of the health care team.
16124722|NCT01974518|Drug|Rituximab and Cyclophosphamide IV|
16124726|NCT01974479|Biological|anti-CD19 redirected NK cells|Haploidentical donor NK cells will be expanded and electroporated over 10 days and infused. NK cells will be infused at single dose on day 0. The patient will receive cyclophosphamide 60mg/kg on day - 7 , and Fludarabine 25 mg/m2/day will be given on day -6 to day -2 prior to the NK cell infusion. IL- 2 will be given subcutaneously for 6 doses every alternate day starting on day -1, for NK cell survival.
16124727|NCT01974466|Other|Goal A|controled fluid therapy：10~5ml/kg/h，crystalloid vs colloid 2:1 resuscitation target： fulfillment of two or more of four criteria:1. HR <120 beats/min, 2.MAP 65-85 mm Hg, 3. urine output ≥1 ml/kg /h 4. HCT ≤35%.
16124728|NCT01974466|Other|Goal B|"controled fluid therapy：10~5ml/kg/h，crystalloid vs colloid 2:1 resuscitation target： fulfillment of all of the following criteria:
~1 CVP 8-12 mmHg , 2.MAP 65-85 mm Hg, 3. urine output ≥0.5 ml/kg/h 4. ScvO2 ≤70%"
16124729|NCT01974453|Radiation|Radiation dose|Radiation dose adsorbed by operators
16124730|NCT01974440|Drug|Bendamustine|90 milligram per meter square (mg/m^2) administered intravenously on Days 1 to 2 of Cycles 1 to 6.
16124731|NCT01974440|Drug|Rituximab|375 mg/m^2 administered intravenously on Day 1 of Cycles 1 to 6.
16124732|NCT01974440|Drug|Cyclophosphamide|750 mg/m^2 administered intravenously on Day 1 of Cycles 1 to 6.
16124733|NCT01974440|Drug|Doxorubicin|50 mg/m^2 administered intravenously on Day 1 of Cycles 1 to 6.
16124734|NCT01974440|Drug|Vincristine|1.4 mg/m^2 (maximum total 2 mg) administered intravenously on Day 1 of Cycles 1 to 6.
16124735|NCT01974440|Drug|Prednisone|100 mg administered orally on Days 1 to 5 of Cycles 1 to 6.
16124736|NCT01974440|Drug|PCI-32765 (Ibrutinib)|560 mg (4*140 mg) capsules administered orally once daily, continuously starting on Cycle 1, Day 1.
16124737|NCT01974440|Drug|Placebo|Placebo (4 capsules) matched to ibrutinib administered orally once daily, continuously starting on Cycle 1, Day 1.
16124738|NCT01974414|Drug|orally administered cedar honey|
16124739|NCT01974401|Device|supragingival irrigators containing chlorhexidine|patients received irrigation by oxyjet supra gingival irrigators containing chlorhexidine for at least 3 minutes for all dentulous regions of jaws which was performed by researchers once daily.
16124740|NCT01974388|Procedure|LSG started 2 cm from the pylorus|Laparoscopic sleeve gastrectomy started 2 cm from pylorus
16124741|NCT01974388|Procedure|LSG started 6 cm from pylorus|LSG started 6 cm from pylorus
16124742|NCT01974375|Drug|micafungin|Micafungin 100 mg/day intravenous (2.0 mg/kg/day in subjects weighing <40 kg)
16124743|NCT01974375|Drug|Fluconazole|Fluconazole 100~200mg/day, IV care until oral medication becomes possible
16124744|NCT01974362|Device|Dental Implant|Place dental implants in both jaws (maxilla and mandible) according to manufacturer specifications
16124745|NCT01974362|Device|Monolithic Zirconia|rehabilitation with monolithic zirconia implant-prosthesis
16124746|NCT01974362|Device|Zirconia-Feldspathic|restore dental implants with a zirconia suprastructure and feldspathic veneers
16124747|NCT01974349|Drug|selumetinib (oral)|Volunteers will receive: 75 mg selumetinib oral dose in a fasted state (Treatment A) followed by a second 75 mg selumetinib oral dose in the fed state (Treatment B) with a washout period of at least 7 days between doses, or: 75 mg selumetinib oral dose in the fed state (Treatment B) followed by a second 75 mg selumetinib oral dose in the fasted state (Treatment A) with a washout period of at least 7 days between doses.
16124748|NCT01974336|Drug|ursodeoxycholic acid|
16124749|NCT01974323|Drug|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
16124750|NCT01974323|Drug|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
16124751|NCT01974310|Procedure|Vitrectomy & Intraocular gas fill|
16124752|NCT01974310|Procedure|Postoperative face-down positioning|
16124753|NCT01974297|Drug|Atorvastatin 10mg, fenofibric acid 135mg|Atorvastatin 10mg, fenofibric acid 135mg/day PO for 12 weeks
16124754|NCT01974297|Drug|atorvastatin 20mg|Atorvastatin 20mg/day PO for 12weeks
16124755|NCT01974284|Drug|percutaneous ethanol ablation|The volume of 99% ethanol to be injected is calculated using a standardized formula. Ethanol is instilled with a needle under ultrasound guidance after administration of local anesthesia.
16124756|NCT01974258|Drug|Cobimetinib|Escalating dose
16124757|NCT01974258|Drug|Cobimetinib|Orally administered once daily for 21 consecutive days, followed by 7 days off.
16124758|NCT01974258|Drug|Onartuzumab|Administered by IV infusion every 2 weeks
16124759|NCT01974258|Drug|Vemurafenib|Orally administered twice daily
16124760|NCT01974245|Drug|Cholecalciferol|100,000 IU/week for 12 weeks
16124761|NCT01974245|Drug|Placebo|100 drops/ week for 12 weeks
16124762|NCT01974206|Biological|ASP0113|intramuscular injection
16124763|NCT01974206|Drug|Placebo|intramuscular injection
16124764|NCT01974193|Drug|Floseal|application of floseal on intervention arm
16124765|NCT01974167|Drug|Eldecalcitol|Eldecalcitol 0.75 microgram once daily orally
16124766|NCT01974167|Drug|Alfacalcidol|Alfacalcidol 1 microgram once daily orally
16124767|NCT01974154|Other|Cohort I|We will evaluate serum and lung ELF obtained by bronchoalveolar lavage, under previous protocols, from 159 individuals at baseline and at 0, 3, 6 and 12 months.
16124768|NCT01974154|Other|Cohort II|Quantify the cilia length on prepared slides from 67 cohort II samples of airway epithelium from biological samples were already obtained from subjects who were consented to participate in prior WCMC IRB approved protocols.
16124769|NCT01974141|Drug|Dapsone Gel|Dapsone gel applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
16124770|NCT01974141|Drug|Dapsone Gel Vehicle|Dapsone gel vehicle applied topically to the face and to affected areas of the trunk once daily for 12 weeks.
16124771|NCT01974128|Procedure|ASC isolation and implantation|This trial will study ASC implantation using a catheter delivery system. ASCs will be derived from the patient's adipose-derived tissue. Liposuction will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The injection catheter will be used for delivery of the ASCs therapy
16124805|NCT01973816|Drug|Triptoreline 11.25 i.v.; Estradiol 0.5% percutaneous gel;|Triptoreline 11.25 administered for 3 months, two consecutive cures Estradiol administered daily for 6 months
16124806|NCT01973816|Procedure|rectal shaving; rectal disc excision; colorectal resection|
16124772|NCT01974115|Device|Radial extracorporeal shock wave therapy|All patients were treated with radial extracorporeal shock waves using the Swiss Dolorclast (Electro Medical Systems S.A., Nyon, Switzerland) and the Power+ handpiece with the 36-mm applicator. Patients were treated unilaterally with two weekly treatments for four weeks on a randomly selected leg (left or right), totaling eight treatments on the selected side. After the application of coupling gel, treatment was performed at 3.5 to 4 bar, with 15,000 impulses per session, and applied at 15 Hz. Impulses were applied homogeneously over the posterior thigh and buttock area. One patient was treated on both legs, with each leg considered an independent treatment.
16124773|NCT01974102|Behavioral|Lifestyle counseling|Active control group will receive weekly session for viewing relaxing video and discussion plus nutritional and physical activity counseling for 8 weeks.
16124774|NCT01974102|Behavioral|Parenting Mindfully for Health (PMH)|Active participants will receive 8 weeks of mindfulness based parenting stress reduction (PMH) plus nutritional and physical activity counseling for 8 weeks.
16124775|NCT01974089|Other|Dysphagia|Oropharyngeal dysphagia assessed by Volume-Viscosity Svallowing Test
16124776|NCT01974076|Device|Active tDCS + CBT|
16124777|NCT01974076|Device|Sham tDCS + CBT|
16124778|NCT01974050|Behavioral|Text message surveillance|
16124779|NCT01974037|Dietary Supplement|Capsaicin|Capsaicin in the concentration of 0.5 µmol/L was mixed in the test solutions in Capsaicin_effect subgroups
16124780|NCT01974037|Dietary Supplement|NaCl|NaCl in various concentrations was desorved in the test solutions in Salt_effect subgroups
16124781|NCT01974024|Drug|methylprednisolone|Adult patients who experienced DIH within 3 days after the administration of dexamethasone as an antiemetic were screened. Eligible patients were randomly assigned to receive dexamethasone or methylprednisolone as an antiemetic (randomization phase). In the next cycle of chemotherapy, the dexamethasone group received methylprednisolone and vice versa in the methylprednisolone group (crossover phase).
16124782|NCT01974011|Procedure|Performing dorsal penile nerve block (DPNB)|
16124783|NCT01973998|Drug|Roflumilast|PDE4 inhibitor
16124784|NCT01973998|Drug|Placebo|Inactive substance.
16124785|NCT01973985|Other|Pleural Manometry|Intrapleural pressure will be monitored with the use of an electronic pleural manometer (Mirador Biomedical CompassTM Thoracentesis Assist Device).
16124786|NCT01973985|Other|Thoracic ultrasonography|"Thoracic ultrasound scan will be done before drainage of pleural effusion - all participants.
~Thoracic ultrasound scans will also be done during drainage of pleural effusion and the results will be recorded after every 100mL of pleural fluid drained - all participants.
~Thoracic ultrasound scan will be done after drainage of pleural effusion - all participants.
~Thoracic ultrasound scan will also be be done during clinic follow-up as part of routine clinical care - all participants."
16124787|NCT01973985|Procedure|Pleural aspiration catheter OR chest drain (standard care)|Insertion of pleural aspiration catheter OR intercostal chest drain under ultrasound guidance - all participants (standard care).
16124788|NCT01973985|Procedure|Talc slurry pleurodesis via chest drain (standard care)|Talc slurry pleurodesis via intercostal chest drain where/when clinically indicated as part of routine clinical care participants with intercostal chest drain only (standard care).
16124789|NCT01973972|Behavioral|Weight management|Weight management group visits using low-carbohydrate diet followed for weight management.
16124790|NCT01973972|Behavioral|Shared medical appointments (SMA)|Diabetes management group visits for diabetes management.
16124791|NCT01973946|Other|Symptom Alert and Coaching|Patients heard self-care messages when they reported a symptom was present. The Symptom Alert and Coaching intervention alerted study nurse practitioners of unresolved symptoms daily. The NPs responded to all alerts generated by patients and using evidence based guidelines, called patients to further assess and to intensify symptom treatment.
16124792|NCT01973933|Drug|Metformin and Pyrimethamine|
16124793|NCT01973920|Drug|Oshadi Icp|
16124794|NCT01973907|Other|Fluid Sparing Resuscitation Strategy|"Tier 1: Initiate IV/IO vasoactive medication infusion support immediately. Further IV/IO isotonic fluid bolus therapy [crystalloid (0.9% Normal Saline or Ringers Lactate) or colloid (5% Albumin)] should be avoided; small volume isotonic fluid boluses [5-10 mL/kg (250-500 mL for participants ≥ 50 kg)] may be provided if required due to A. Clinically unacceptable delay in ability to initiate vasoactive medication infusion(s) and/or 2. Documented intravascular hypovolemia.
~Tier 2: Vasoactive medication(s) should be preferentially titrated/escalated to achieve recommended ACCM hemodynamic goals. Further IV/IO isotonic fluid bolus therapy [crystalloid (0.9% Normal Saline or Ringers Lactate) or colloid (5% Albumin)] should be avoided; small volume isotonic fluid boluses [5-10 mL/kg (250-500 mL for participants ≥ 50 kg)] may be provided if required due to A. Documented intravascular hypovolemia.
~Intervention end: Patient is free from vasoactive medication support and shock is reversed."
16124795|NCT01973894|Procedure|Blood and urine sampling|"Blood and urine sampling will follow this schedule:
~24h: blood (3ml)
~48h: blood (3ml) and urine
~End of infusion: blood (3ml)
~6h after end of infusion: blood (3ml) and urine. Blood samples will be centrifuged for 10 minutes at 3300rpm, then supernatant will be placed into test tubes and stored at -20°C; urine samples will be freeze at -20°C as well.
~Then all frozen samples will be analyzed to get Midazolam concentrations."
16124796|NCT01973881|Procedure|T1 Weighted MRI (magnetic resonance imaging)|"Enrolled subjects will have an MRI scan performed at baseline (within 1 month before beginning therapy), at the time of a scheduled bone marrow biopsy or end of treatment cycle (6 months), and after 12 months.
~Please note: Patients in this study will be treated with chemotherapy as determined by the hematologist or the treatment protocol for an independent clinical trial for therapy of myelofibrosis. Treatment and monitoring will be performed under the usual standard of care that includes physical examinations, laboratory testing, and other indicated imaging examinations."
16124797|NCT01973868|Drug|Regorafenib (Stivarga, BAY73-4506)|
16124798|NCT01973868|Drug|Cetuximab (ERBITUX)|
16124799|NCT01973855|Drug|Western Medicine|Physical cooling,Hydrocortisone
16124800|NCT01973855|Drug|TCM and Western Medicine|Third Infectious diseases soup recipe
16124801|NCT01973842|Drug|0.1 mg triptorelin|
16124802|NCT01973842|Drug|0.2 mg triptorelin|
16124803|NCT01973842|Drug|0.4 mg triptorelin|
16124804|NCT01973829|Other|Checklist for Early Recognition and Treatment of Acute Illness (CERTAIN)|This study is about training and implementation of best critical care practices in the international ICUs with variable resources facilitated by access to a specifically designed electronic checklist
16124811|NCT01973764|Procedure|Ultrasound guided ventricular drain insertion|Ventricular puncture and insertion of the intraventricular catheter is performed under ultrasound guidance.
16124812|NCT01973764|Procedure|landmark-based ventricular drain insertion|Ventricular puncture and insertion of the intraventricular catheter is performed without any guiding devices and is based on anatomical landmarks.
16124813|NCT01973751|Drug|Budesonide|Inhaled powder of inhaled corticosteroid, 2 puffs (200mcg) twice a day for 8 weeks
16124814|NCT01973725|Drug|Icotinib Hydrochloride|Patients will receive Icotinib Hydrochloride at 125mg/times,oral three times daily for 21 days.
16124815|NCT01973712|Procedure|Locked Compression Plating|
16124816|NCT01973712|Procedure|Retrograde Intramedullary Nailing (RIMN)|
16124817|NCT01973699|Other|visualization in shoulder arthroscopy|Evaluating the effect of performing shoulder arthroscopy with and without epinephrine on visualization
16124818|NCT01973686|Behavioral|Physical activity|
16124819|NCT01973673|Behavioral|Bone health educational materials|
16124820|NCT01973660|Drug|Lapatinib|
16124821|NCT01973660|Drug|Trastuzumab|
16124822|NCT01973660|Drug|Endocrine Therapy|Letrozole or tamoxifen will be prescribed according to patient's menopausal status
16124823|NCT01973660|Drug|Paclitaxel|Only administrated if tumor progression is observed by US on week 6
16124824|NCT01973647|Behavioral|Cognitive Behavioral Therapy for Insomnia|Six weekly sessions of cognitive behavioral therapy for insomnia
16124825|NCT01973647|Behavioral|COPD Education|Six weekly sessions of COPD education
16124826|NCT01973647|Behavioral|Attention Control|Six weekly sessions of non-sleep, non-COPD health education
16124827|NCT01973634|Radiation|sequential boost (15 x 2.67 Gy WBI + 4 x 2.5 Gy boost)|Minimal surgical margin of 1 mm, conventional arm with sequential boost (15 x 2.67 Gy WBI + 4 x 2.5 Gy boost)
16124828|NCT01973634|Radiation|SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.12 Gy)|Minimal surgical margin of 1 mm, experimental arm with SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.12 Gy)
16124829|NCT01973634|Radiation|sequential boost (15 x 2.67 Gy WBI + 6 x 2.48 Gy boost)|Minimal surgical margin < 1 mm, conventional arm with sequential boost (15 x 2.67 Gy WBI + 6 x 2.48 Gy boost)
16124830|NCT01973634|Radiation|SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.33 Gy)|Minimal surgical margin < 1 mm, experimental arm with SIB (15 x 2.67 Gy WBI and SIB 15 x 2.67-3.33 Gy)
16124831|NCT01973608|Drug|MSB0010445 (0.3 milligram per kilogram [mg/kg])|MSB0010445 will be administered at a single dose of 0.3 mg/kg as intravenous (IV) infusion over approximately 1 hour every 3 weeks (q3w) for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 will be performed 3 days after the last dose of Stereotactic Body Radiation Therapy (SBRT) to the targeted reference lesion.
16124832|NCT01973608|Drug|MSB0010445 (1.0 mg/kg)|MSB0010445 will be administered at a single dose of 1.0 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 will be performed 3 days after the last dose of SBRT to the targeted reference lesion.
16124833|NCT01973608|Drug|MSB0010445 (1.8 mg/kg)|MSB0010445 will be administered at a single dose of 1.8 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 will be performed 3 days after the last dose of SBRT to the targeted reference lesion.
16124834|NCT01973608|Drug|MSB0010445 (2.4 mg/kg)|MSB0010445 will be administered at a single dose of 2.4 mg/kg as IV infusion over approximately 1 hour q3w for the first 12 Weeks as a part of induction phase followed by maintenance dose of 0.3 mg/kg drug every three weeks until significant clinical progression, occurrence of unacceptable toxicity, or withdrawal of consent. The first administration of MSB0010445 will be performed 3 days after the last dose of SBRT to the targeted reference lesion.
16124835|NCT01973608|Radiation|Stereotactic Body Radiation Therapy (SBRT)|SBRT will be administered using a dose and schedule recommended based upon the data showing the best abscopal effect using multiple fractions if one site will be targeted subject received 3 fractions (1 per day) of 8 Gray (Gy) each (total: 24 Gy). If the target lesion will be located in the thorax, the maximum total dose administered will be 18 Gy (3 x 6 Gy).
16124836|NCT01973595|Dietary Supplement|Almonds, Then no almonds|Whole, raw almonds with skin, or whole, raw almonds with skin that have been ground into a paste.
16124837|NCT01973595|Other|No Almonds, Then almonds|No almonds will be consumed by participants for 3 weeks.
16124838|NCT01973569|Drug|denosumab|denosumab administered subcutaneously
16124839|NCT01973569|Drug|placebo|placebo administered subcutaneously to match denosumab
16124840|NCT01973556|Other|Pharmacist-Physician Collaborative Medication Therapy Management|
16124841|NCT01973543|Biological|VY-AADC01|Neurosurgical delivery of VY-AADC01 to the brain.
16124842|NCT01973530|Procedure|adductor canal block|Continuous adductor canal block and single shot posterior tibial nerve block under ultrasound guidance and using nerve stimulating needle (bolus: 0.5% Ropivacaine 10-15ml with dexamethasone 4mg ;with single shot posterior tibial nerve block (8-10ml 0.5% ropivacaine)
16124843|NCT01973530|Procedure|femoral nerve block|Femoral nerve catheter inserted under ultrasound guidance using nerve stimulating needle administering ropivacaine bolus 10-15ml and infusing 0.2% ropivacaine at 4-6ml/h; plus a single shot posterior tibial nerve block under ultrasound guidance and use of nerve stimulating needle
16124844|NCT01973517|Drug|Feraheme|Patients with relapsing remitting multiple sclerosis will be administered Feraheme 5mg/kg IV via slow push once and imaged under high-field MRI at least 24 hours following administration, to allow for adequate clearance of intravascular pharmaceutical.
16124845|NCT01973517|Drug|Gadolinium-based contrast|Patients with relapsing remitting multiple sclerosis will be administered gadolinium-based contrast at a dose of 0.1 mmol/kg IV once and imaged under high-field MRI immediately following administration.
16124846|NCT01973504|Drug|MP4OX|4.3 g/dL pegylated hemoglobin in balanced lactate-electrolyte solution
16124847|NCT01973504|Drug|Control|Crystalloid solution IV infusion drip to keep vein open
16124958|NCT01972711|Drug|Placebo|single oral dose placebo
16124848|NCT01973491|Drug|ATX-MS-1467|Subjects will receive ATX-MS-1467 50 microgram (mcg), 200 mcg and 800 mcg on Day 1, Day 15 and Day 29 respectively during the titration period followed by biweekly dose of ATX-MS-1467 800 mcg for 16 weeks during the treatment period.
16124849|NCT01973478|Device|DBS|
16124850|NCT01973478|Device|SHAM|
16124851|NCT01973465|Biological|Stool|Implanting fecal matter via colonscope
16124852|NCT01973452|Drug|Dexmedetomidine|
16124853|NCT01973452|Drug|Placebo|
16124854|NCT01973439|Other|Intervention 1: PK assessment while on Twice Daily Abacavir|Week 0
16124855|NCT01973439|Other|Intervention 2: PK assessment while on Once Daily Abacavir|Week 4
16124856|NCT01973426|Device|Isolated Orthosis for Thumb Actuation (IOTA)|In this pilot study, we plan to investigate whether the IOTA can effectively facilitate the ability of participants to perform a specific set of clinically relevant tasks conducted in a clinic setting. The IOTA is a device developed at the Wyss Institute at Harvard University, in collaboration with Children's Hospital Boston, for assisting opposable thumb grasping tasks. The IOTA contains an adjustable brace fitted to the thumb and dorsum of the hand that is easy to put on and facilitates grasping motions through flexible cable-driven actuators that assist with joint abduction and extension.
16124857|NCT01973413|Device|Diabetes Assistant (DiAs)|The Control-to-Range (CTR) algorithm that will be used in DiAs will automatically adjusts insulin delivery in response to CGM values that have exceeded or are predicted to exceed the bounds of a pre-specified blood glucose range.
16124858|NCT01973413|Device|Tandem t:slim Insulin Pump|FDA, market-approved insulin pump.
16124859|NCT01973413|Device|Dexcom G4 Platinum sensor|FDA, market-approved continuous glucose monitor (CGM)
16124860|NCT01973400|Dietary Supplement|Tocotrienol|Palm-Oil derived Vitamin E, tocotrienol
16124861|NCT01973400|Dietary Supplement|Placebo|Placebo
16124862|NCT01973387|Drug|Rituximab|Up to 6 cycles (total of 8 doses administered by intravenous infusion): 375 mg/m2 on Day 1 of Cycle 1, 500 mg/m2 on Day 15 of Cycle 1 (Weeks 1-4); 500 mg/m2 on Day 1 and Day 15 of Cycle 2 (Weeks 5-8); and 500 mg/m2 on Day 1 of Cycles 3-6 (Weeks 9-24).
16124863|NCT01973387|Drug|Ibrutinib|420 mg capsules administered by mouth daily until disease progression or unacceptable toxicity, whichever occurs first.
16124864|NCT01973374|Behavioral|Text Message Intervention|
16124865|NCT01973361|Device|Ultrasound debridement|Ultrasound-assisted wound debridement with saline irrigant applied for 5 - 15 minutes until visible and removable non-viable appearance tissue is removed to reveal a healthy appearance wound bed.
16124866|NCT01973361|Device|Best practice wound care|Participants will receive moist wound care with addition of silver alginate dressing for visual cues of infection.
16124867|NCT01973348|Device|4-hour AmblyZ glasses|4-hour AmblyZ glasses for moderate amblyopia
16124868|NCT01973348|Device|12-hour AmblyZ glasses|12-hour AmblyZ glasses for severe amblyopia
16124869|NCT01973348|Device|2-hour patching|2-hour patching for moderate amblyopia
16124870|NCT01973348|Device|6-hour patching|6-hour patching for severe amblyopia
16124871|NCT01973335|Drug|Combination therapy with acetazolamide and low-dose loop diuretics|"Patients receive 500 mg of intravenous acetazolamide immediately after randomization, with 250 mg intravenous acetazolamide administered on each consecutive day in the morning for as long as the patient is considered volume overloaded by his/her treating cardiologist.
~Patients receive 2 mg of intravenous bumetanide immediately after randomization, with 1 mg intravenous bumetanide administered on each consecutive day in the morning for as long as the patient is considered volume overloaded by his/her treating cardiologist.
~If diuresis <1,5 L while the patient is still considered volume overloaded by his/her treating cardiologist, the dose of acetazolamide is maintained at 500 mg and the dose of bumetanide is maintained at 2mg.
~In case of therapy-refractory congestion, treatment is at the discretion of the treating physician, but addition of chlorthalidone 50 mg PO is recommended by the investigators as a first-line option."
16124872|NCT01973335|Drug|High-dose loop diuretics|"Patients receive the double of their daily maintenance dose of oral loop diuretics converted to mg bumetanide as an intravenous bolus after randomization.
~Patients continue to receive this dose daily on the next 3 days divided between two administrations with at least a 6 h interval for as long as they are considered volume overloaded by the treating cardiologist.
~If diuresis <1,5 L while the patient is still considered volume overloaded by the treating cardiologist, the dose of bumetanide is doubled.
~In case of therapy-refractory congestion, treatment is at the discretion of the treating physician, but addition of chlorthalidone 50 mg PO is recommended by the investigators as a first-line option."
16124873|NCT01973335|Drug|Upfront therapy with oral spironolactone|"Patients randomized to this group receive oral spironolactone (25mg) immediately after randomization and in the morning of each subsequent day unless the serum potassium level is >5 mmol/L.
~Note: Investigators and treating physicians are blinded to treatment allocation for this arm, but no matching placebo is provided, so patients are not."
16124874|NCT01973322|Other|arm 1: DC Vaccine + RT|three daily doses of 8 Gy up to 12 Gy delivered to one non-index metastatic field between vaccine doses 1 and 2 (optional to one additional field between vaccine doses 7 and 8) utilizing IMRT-IMAT techniques
16124875|NCT01973322|Other|arm 2: DC Vaccine + IFN-alfa|daily 3 MU subcutaneous IFN-alfa for 7 days before leukapheresis (day -15 to -9, and for 7 days before any other additional leukapheresis)
16124876|NCT01973322|Other|arm 3: both arm 1 and 2 + RT|both 1 and 2 external immunostimulant conditions (Intradermal Autologous Dendritic Cell Vaccine + 3 single boosts of RT + IFN-alfa, 3 MU daily for 7 days before leukapheresis)
16124877|NCT01973322|Biological|arm 4: DC Vaccine|neither 1 or 2 external immunostimulant conditions (only Intradermal Autologous Dendritic Cell Vaccine)
16124878|NCT01973309|Drug|Vantictumab combined with paclitaxel|Vantictumab combined with paclitaxel will be administered IV.
16124879|NCT01973296|Behavioral|ED to home care transition|The CTI coach's role is to build self-management capabilities for the patient and caregiver. During each contact, the coach reviews the four components of the CTI: 1: Follow-up Medical Visit. 2: Knowledge of Red Flag Symptoms. 3: Medication Reconciliation. 4: The Personal Health Record (PHR). The coach assists the patient use the PHR to document and maintain vital information and to communicate with providers.
16124880|NCT01973296|Other|Usual Care|Patients randomized to usual care will receive verbal and written discharge instructions from the treating emergency department physician and nurse as is the standard of care.
16125075|NCT01971749|Procedure|Coronary stent procedure (CSP)|
16124881|NCT01973283|Drug|Antidepressant Medication|If patient has a history of non-response or cannot tolerate escitalopram and/or duloxetine, then they will be treated openly with an approved antidepressant.
16124882|NCT01973270|Behavioral|Neuroadaptive cognitive training|TCT exercises consist of three modules: an Auditory Processing Module (40-50 hours of training); a Visual Processing Module (30 hours); a Cognitive Control Module prototype (20 hours). [Based on the results of our current RCT, Posit Science has revised aspects of the training modules in order to further optimize its effectiveness for treatment of schizophrenia. In this study, we will use updated versions of the training software: an Auditory Module (20 hours), and a Social Module (10 hours). Features from the Cognitive Control module prototype have been expanded and incorporated into these new modules.
16124883|NCT01973257|Procedure|imaging diagnostics|
16124884|NCT01973244|Drug|somapacitan|"A single dose administered subcutaneously (s.c., under the skin) of 4 different doses of NNC0195-0092 in an escalating order.
~Each subject will be allocated to one dose level only. After completion of each dose cohort, a safety evaluation will be conducted prior to dose escalation."
16124885|NCT01973244|Drug|somatropin|Administered subcutaneously (s.c., under the skin) once daily for 7 days. The daily dose is 0.03 mg/kg/day.
16124886|NCT01973231|Drug|liraglutide|Starting dose of 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day is reached. Administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial metformin (equal to or above 1000 mg/day and up to 3000 mg/day).
16124887|NCT01973231|Drug|lixisenatide|Starting dose of 10 microg to be administered s.c. once daily, within the hour prior to the first meal of the day or the evening meal in addition to subject's stable pre-trial metformin (equal to or above 1000mg/day and up to 3000mg/day). Dose escalation to 20 microg s.c. once daily from day 15 after randomization.
16124888|NCT01973218|Biological|Meningococcal B Recombinant vaccine rMenB+OMV NZ|Subjects were randomized to one of two treatment groups to receive intramuscular (IM) vaccination with two doses of rMenV+OMV NZ vaccine (0.5 mL) in the non-dominant arm, one month apart. Subjects were followed for two months.
16124889|NCT01973218|Biological|Placebo|Subjects were randomized to one of two treatment groups to receive intramuscular (IM) injection of saline solution followed by one dose of MenACWY-CRM vaccine (0.5 mL), one month apart. Subjects were followed for two months.
16124890|NCT01973218|Biological|Meningococcal ACWY-CRM conjugate vaccine|Subjects were randomized to one of two treatment groups to receive intramuscular (IM) injection of saline solution followed by one dose of MenACWY-CRM vaccine (0.5 mL), one month apart. Subjects were followed for two months.
16124891|NCT01973205|Drug|Acetaminophen 250 mg and Aspirin 250 mg|2 tablets each containing Acetaminophen 250 mg and Aspirin 250 mg
16124892|NCT01973205|Drug|Placebo|2 placebo tablets matching acetaminophen 250 mg and aspirin 250 mg tablets
16124893|NCT01973179|Radiation|Radiation therapy|Radiation therapy with protons
16124894|NCT01973166|Device|Picosecond Q-switched Laser Treatment|
16124895|NCT01973166|Device|Nanosecond Q-switched Laser Treatment|
16124896|NCT01973153|Behavioral|Brief Motivational Counseling (BMC)|3-5 minute BMC delivered by clinicians and nurses at well, sick, and WIC visits with the goal of reducing obesogenic behaviors. During BMC, the medical team facilitates the selection of a specific goal (i.e., reduce sugar sweetened beverage consumption) that is meaningful to the mother and teaches the mother simple behavioral strategies.
16124897|NCT01973153|Behavioral|Brief Motivational Counseling Plus Phone Calls (BMC + Phone)|BMC as described above that is supplemented by monthly telephone contacts with community health workers designed to identify and overcome barriers to goal progress.
16124898|NCT01973153|Behavioral|Brief Motivational Counseling Plus Home Visits (BMC + Home)|BMC as described above that is supplemented by monthly home visits with community health workers designed to identify and overcome barriers to goal progress.
16124899|NCT01973140|Drug|Tolvaptan|Adult male volunteers will be given a given a 60mg or a 30 mg dose of tolvaptan. Blood and urine samples will be collected at specified time points for the next 24 hours.
16124900|NCT01973140|Drug|Hypertonic saline infusion|A week after the first intervention(tolvaptan), the subjects will undergo a hypertonic saline infusion for 6 hours. Blood and urine samples will be collected at specified time points until 4hour hours after the infusion.
16124901|NCT01973127|Other|Verum rTMS|rTMS on the right dorsolateral prefrontal cortex. TMS procedure: The resting motor threshold (RMT) will be defined in each subject as the minimal stimulation intensity evoking an MEP of ≥ 0.05 mV in 50% of the trials in the muscle of the right thumb (M. abductor pollicis brevis). TMS will be conducted in the form of 'conventional rTMS', whereby 30 trains of 10 Hz pulses with a duration of 5 seconds and an inter-train interval of 25 seconds are applied to the righ dorsolateral prefrontal cortex (50 pulses per train, 6000 pulses per session). Used equipment: Magstim Rapid 2 device.
16124902|NCT01973127|Other|Sham rTMS|TMS procedure: The resting motor threshold (RMT) will be defined in each subject as the minimal stimulation intensity evoking an MEP of ≥ 0.05 mV in 50% of the trials in the muscle of the right thumb (M. abductor pollicis brevis). Like in verum TMS coil will be placed on the skull, but no magnetic field will be pulsed. Used equipment: Magstim Rapid 2 device.
16124903|NCT01973114|Drug|Latanoprost|
16124904|NCT01973114|Other|Placebo|
16124905|NCT01973101|Drug|Cisplatin|50 mg/m2 - Day 1
16124906|NCT01973101|Drug|Gemcitabine|Gemcitabine 1000mg/m2 on day 1 and day 8.
16124907|NCT01973101|Drug|cisplatin|Cisplatin 40 mg/m2 on day 1, day8, day15, day22, day 36 of radiotherapy period.
16124908|NCT01973101|Radiation|Radiotherapy|45 Gy
16124909|NCT01973101|Radiation|Brachytherapy|80 Gy
16124910|NCT01973062|Biological|rituximab|Given IV
16124911|NCT01973062|Radiation|yttrium Y 90 ibritumomab tiuxetan|Given IV
16124912|NCT01973049|Drug|Daclatasvir|
16124913|NCT01973049|Drug|Asunaprevir|
16124914|NCT01973049|Drug|BMS-791325|
16124915|NCT01973049|Drug|Ribavirin|
16124916|NCT01973049|Drug|Placebo matching Ribavirin|
16124917|NCT01973036|Device|Foley Catheter|The balloon will be inflated with 30 cc of sterile saline. The catheter will be taped to the patient's leg so that traction is maintained. The catheter will be assessed hourly for expulsion by a health care provider by applying gentle traction on the catheter or a vaginal examination if it is unclear by traction. Once the Foley catheter is expelled or 12 hours reached, the induction will be continued with oxytocin per this protocol.
16124918|NCT01973036|Drug|Oxytocin|Each arm will receive oxytocin at a rate of 2 milliunits/milliliter. If the fetal status is reassuring, this can be increased by 2 milliunits/milliliter every 30 minutes to achieve an adequate contraction pattern as per the institution's definition to a maximum of 30 milliunits/milliliter. This infusion may be continued until delivery.
16124919|NCT01973023|Other|Motion analysis|Motion analysis was used to assess the modifications of gait pattern in chronic spastic stroke patients regularly treated with botulinum toxin injection
16124920|NCT01973010|Other|Massage|Massage therapy is an intervention that can be used to relax muscle and regulate displaced joints by manual manipulation.
16124921|NCT01973010|Drug|Ibuprofen|Ibuprofen is an common analgesics which has been widely used in regular control of various pain symptom.
16124922|NCT01972997|Device|SENSIMED Triggerfish|
16124923|NCT01972984|Drug|Anastrozole|Participants will be instructed to take one tablet of anastrozole orally per day with fluids. This tablet will be taken at the same time every day. Participants will be given a drug diary to record drug administration and aid in drug compliance. Should the participant miss a dose they will be asked to record it in their diary and resume the normal dose schedule the next day.
16124924|NCT01972971|Other|patient education|one by one patient education
16124925|NCT01972958|Other|comprehensive care|comprehensice assessment,physical activity training, community resources referral, health education.
16124926|NCT01972945|Procedure|Vaginoscopy|Vaginoscopy, otherwise known as the 'no touch' technique, describes a technique where the hysteroscope is guided into the uterus without the need for potentially painful vaginal instrumentation i.e. passage of a vaginal speculum to separate the vaginal walls, cleansing of the cervix and sometimes application of traumatic forceps to the ectocervix in order to stabilise it.
16124927|NCT01972945|Procedure|Standard Hysteroscopy|Traditional hysteroscopy consists of introducing speculum and grasping of the cervix to provide counter traction to allow instrumentation of the uterus. Introducing a speculum also allows the cervix to be cleaned with sterilising fluid.
16124928|NCT01972932|Dietary Supplement|Bio K+® 2 capsules orally (or via nasogastric tube)|Bio-K+® 2 capsules orally (or via nasogastric tube) once per day starting at randomization until five days after the discontinuation of the antibiotic.
16124929|NCT01972932|Dietary Supplement|Placebo|Placebo Comparator: 2 capsules orally (or via nasogastric tube) once per day starting randomization until five days after the discontinuation of the antibiotic.
16124930|NCT01972919|Radiation|Radiation Therapy|Radiation therapy dose escalation to an MR-defined gross tumor volume (GTV) of up to 69.75 Gy at 2.25 Gy per fraction.
16124931|NCT01972919|Drug|Concurrent chemotherapy (Gemcitabine, Capecitabine)|Gemcitabine 400mg/m2 IV weekly x 6 doses. Capecitabine 825 mg/m^2 by mouth twice daily Monday-Friday on days of radiation use 500mg tablets.
16124932|NCT01972906|Device|moxibustion|apply moxibustion according to traditional Chinese medicine
16124933|NCT01972906|Drug|Ibuprofen Sustained Release Capsules|apply Ibuprofen (H20013062), 0.3g， Bid, lasting 3 days before menstrual cycle
16124934|NCT01972893|Drug|ZYD1|"Plan I - Tablet ZYD1 - 0.5, 1 , 2, 5, 10, 25 and 50 mg subcutaneously OD after overnight fasting.
~Plan II - Tablet ZYD1 - 0.5, 1 , 2, 5, 10 and 25 mg subcutaneously OD after overnight fasting.
~Plan III - Tablet ZYD1 2/5 mg subcutaneously OD after overnight fasting depending on results of Plan I."
16124935|NCT01972893|Drug|Placebo|"Plan I - Tablet Placebo - 0.5, 1 , 2, 5, 10, 25 and 50 mg subcutaneously OD after overnight fasting.
~Plan II - Tablet Placebo - 0.5, 1 , 2, 5, 10 and 25 mg subcutaneously OD after overnight fasting.
~Plan III - Tablet Placebo 2/5 mg subcutaneously OD after overnight fasting depending on results of Plan I."
16124936|NCT01972880|Drug|ASP1941|Oral
16124937|NCT01972867|Device|NanoKnife Procedure|Subjects will be placed in the dorsal lithotomy position, under sterile technique. The NanoKnife procedure will be carried out under general anesthesia. A Foley catheter will be placed to aid in draining the bladder during treatment.
16124938|NCT01972854|Drug|riboflavin solution|0.12% riboflavin ophthalmic solution
16124939|NCT01972854|Drug|placebo solution|0.0% riboflavin ophthalmic solution
16124940|NCT01972854|Device|KXL System|30mW/cm2
16124941|NCT01972841|Drug|Solifenacin succinate|Oral tablet
16124942|NCT01972841|Drug|Mirabegron|Oral tablet
16124943|NCT01972841|Drug|Placebo to match solifenacin succinate|Oral tablet
16124944|NCT01972841|Drug|Placebo to match mirabegron|Oral tablet
16124945|NCT01972828|Drug|FLUID MANAGEMENT GUIDED WITH PRELOAD-DEPENDENCE PARAMETERS (VOLUVEN ®)|in this arm, fluid loading is administered with an algorithm using preload dependence indexes. This algorithm is used every hour during the first 6 hours after inclusion, then every 4 hours until vasopressor weaning, and whenever mean arterial pressure fell below 65 mm Hg. Fluid loading is performed with cristalloids or colloids at the discretion of the attending physician.
16124946|NCT01972828|Drug|STANDARD-GUIDED FLUID MANAGEMENT (VOLUVEN ®)|in this arm, fluid loading is administered with an algorithm using central venous pressure. This algorithm is used every hour during the first 6 hours after inclusion, then every 4 hours until vasopressor weaning, and whenever mean arterial pressure fell below 65 mm Hg. Fluid loading is performed with cristalloids or colloids at the discretion of the attending physician.
16124947|NCT01972789|Drug|Ranibizumab|Ranibizumab solution for injection is commercially supplied in two presentations: as a pre-filled syringe (containing 1.65 mg of ranibizumab in 0.165 mL solution) and as a vial (containing 2.3 mg of ranibizumab in 0.23 mL solution) corresponding to a recommended dose of 0.5 mg (0.05 mL) given as a single intravitreal injection. It will be prescribed and administered by the investigator or designee
16124948|NCT01972776|Drug|QBM076|Supplied in 25 mg and 75 mg capsules
16124949|NCT01972776|Drug|Placebo|Matching placebo capsules
16124950|NCT01972763|Drug|Ranibizumab|Ranibizumab is formulated as a sterile solution and will be used in the case of an intervention.
16124951|NCT01972750|Drug|Dovitinib|daily oral intake of capsule
16124952|NCT01972737|Biological|Ad5-hGCC-PADRE vaccine|A single intramuscular dose (100 billion virus particles) of Ad5-hGCC-PADRE vaccine.
16124953|NCT01972724|Drug|Pioglitazone|Pioglitazone tablets
16124954|NCT01972724|Drug|Metformin|Metformin as prescribed in clinical practice
16124955|NCT01972724|Drug|Sulfonylurea|Sulfonylurea as prescribed in clinical practice
16124956|NCT01972711|Drug|SEP-363856|SEP-36385625 as a single oral dose of 50 mg
16124957|NCT01972711|Drug|Amisulpride|Amisulpride as a single oral dose of 400 mg
16124959|NCT01972698|Other|Self-directed and simulation-assisted training|"All participants will attend an ultrasound introductory course (lectures and illustrative interactive cases).
~Participants randomized to the intervention group will undergo a completely self-directed lung and focused cardiac ultrasound curriculum.
~A set of video-lectures on how to perform US on a critically ill patient (video-tutorials on image acquisition, troubleshooting, and pitfalls) will be provided.
~Participant will have access to an ultrasound simulator.
~Finally, participants in the intervention group will be asked to perform self-directed lung and focused cardiac ultrasound examinations on critically ill patients.
~An investigator will supervise the sessions but will not interfere with the self-learning process.
~- To support their learning, trainees will have access to on-line virtual FCU and LUS modules created by the Toronto General Hospital Department of Anesthesia Perioperative Interactive Education (http://pie.med.utoronto.ca/TTE/index.htm)."
16124960|NCT01972698|Other|Traditional apprenticeship training|"All participants will attend an half-day ultrasound introductory course.
~Participants randomized to the conventional group will initially attend 2-hour hands-on session on healthy volunteers, fully supervised by an expert critical care ultrasonographer (acquisition of basic knowledge with US machine settings and probe positioning and orientation, normal view acquisition, and identification of normal anatomical structures and landmarks).
~Subsequently, participants will attend a 3-hours hands-on session on critically ill patients, fully supervised by an expert critical care ultrasonographer."
16124961|NCT01972685|Procedure|Cryobiopsy biopsy|Cryobiopsy vs. Transbronchial vs. VATS biopsy
16124962|NCT01972685|Procedure|Transbronchial Biopsy|
16124963|NCT01972685|Procedure|VATS biopsy|
16124964|NCT01972672|Drug|Icaritin|Icaritin 600 mg orally, twice daily for a total daily dose of 1200 mg
16124965|NCT01972659|Drug|placebo|Active comparator 50 mg/kg iv bolus plus 15 mg/kg continuous infusion
16124966|NCT01972659|Drug|Magnesium Sulphate|"Experimental :
~50 mg/kg bolus plus 15 mg/kg continuous infusion"
16124967|NCT01972659|Drug|sugammadex|4 mg/kg iv bolus at the end of the surgery
16124968|NCT01972633|Procedure|Laser|Endovenous Laser (1470nm) ablation of great or small saphenous vein
16124969|NCT01972633|Procedure|Radiofrequency|Endovenous Radiofrequency (VNUS Closure Fast) of great or small saphenous vein
16124970|NCT01972620|Drug|Bupivacaine|A 50:50 mixture of normal saline (8 ml) and 0.5% Bupivacaine was prepared within a 20 ml syringe (Total volume 16 ml; Final concentration = 0.25%). Following delivery of the gallbladder specimen in the Multi-modal analgesia group, 8 ml of 0.25% bupivacaine solution was sprayed onto the cystic plate (gallbladder fossa) with a spinal needle advanced under direct laparoscopic vision via a 5mm right subcostal laparoscopic port. The anesthetic solution was sprayed at an operating distance from the cystic plate of ~ 2 cm. Following evacuation of the pneumoperitoneum, again within the Multi-modal analgesia group, the remaining 8 ml of 0.25% Bupivacaine was infiltrated subcutaneously at each of the four laparoscopic port sites (2 ml per port site) prior to standard sutured closure of each incision
16124971|NCT01972607|Other|Exercise Training|12 weeks of aerobic exercise training performed 3x/week at moderate intensity with sessions of 40 min.
16124972|NCT01972594|Procedure|Targetted protocol with pedometer|12 week protocol based on targetted steps are given to the patient along with a pedometer.
16124973|NCT01972594|Device|Accelerometer(ActivPAL)|
16124974|NCT01972581|Other|Reaction Time Training|
16124975|NCT01972568|Drug|Atacicept 75 milligram (mg)|Atacicept 75 mg will be administered as subcutaneous injection once weekly for 24 weeks.
16124976|NCT01972568|Drug|Atacicept 150 mg|Atacicept 150 mg will be administered as subcutaneous injection once weekly for 24 weeks.
16124977|NCT01972568|Drug|Placebo|Placebo matched to atacicept will be administered as subcutaneous injection once weekly for 24 weeks.
16124978|NCT01972555|Procedure|Minimally invasive aortic valve replacement|
16124979|NCT01972555|Procedure|Conventional aortic valve replacement|
16124980|NCT01972542|Dietary Supplement|Oral fat tolerance test|
16124981|NCT01972529|Drug|avatrombopag (lower baseline platelet count)|60 mg avatrombopag (3 x 20 mg tablets)
16124982|NCT01972529|Drug|placebo (lower baseline platelet count)|60 mg placebo (3 x 20 mg matching placebo tablets)
16124983|NCT01972529|Drug|avatrombopag (higher baseline platelet count)|40 mg avatrombopag (2 x 20 mg tablets)
16124984|NCT01972529|Drug|placebo (higher baseline platelet count)|40 mg placebo (2 x 20 mg matching placebo tablets)
16124985|NCT01972516|Drug|Tivozanib|
16124986|NCT01972503|Drug|5-FU and oxaliplatin|Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms. In arm A, patients accepted intraoperative intraportal infusion of 5-FU 1g and oxaliplatin 100mg+ curative resection + mFOLFOX6.
16124987|NCT01972503|Procedure|colorectal cancer resection+ adjuvant chemotherapy (mFOLFOX6)|Patients with stage II or stage III colorectal cancer (CRC) were randomly assigned to two arms. All patients in both arms accept curative resection of colorectal cancer,and accept standard adjuvant chemotherapy (mFOLFOX6).
16124988|NCT01972490|Drug|avastin|Drug: avastin On day 1 of a 14 day treatment cycle, patients received a 2-hour infusion of avastin (5mg/kg) followed by chemotherapy of mFOLFOX6 until progressive disease or unacceptable toxicity.
16124989|NCT01972490|Drug|mFOLFOX6|mFOLFOX-6 (oxaliplatin, 85mg/m2 on day 1 infused during 2 hours;LV400mg/m2 on days 1 infused during 2 hours, followed by FU 400 mg/m2 intravenous bolus then 2400 mg/m2 continuous infusion for 46 hours)
16124990|NCT01972477|Drug|DLBS1449|Study treatment will be DLBS1449 softcapsules at a dose of 1x75 mg daily or DLBS1449 at a dose of 1x150 mg daily. DLBS1449 will be given every day for 8 weeks.
16124991|NCT01972477|Other|Placebo|Placebo will be given every day for 8 weeks.
16124992|NCT01972464|Drug|Progesterone|oral micronized progesterone
16124993|NCT01972464|Drug|Placebo|
16124994|NCT01972451|Procedure|Colonoscopy with enhanced dye|
16124995|NCT01972438|Drug|ASEDs|Experimental Intervention
16124996|NCT01972438|Drug|Saline|Control Intervention
16124997|NCT01972425|Other|Biomarker-based diagnostic|The intervention will be a biomarker-based diagnostic test for the exclusion of VAP
16124998|NCT01972412|Behavioral|telephone support|Telephone support for four months about healthy diet, physical activity and medication use.
16124999|NCT01972399|Procedure|Laser|This is a surgery that the patient will undergo and the laser will be used to clean the surface of the implant.
16125076|NCT01971749|Procedure|Coronary-artery bypass grafting (CABG)|
16125000|NCT01972399|Procedure|Mechanical debridement|This is a surgery that the patient will undergo to have the surface of the implant cleaned using hand instruments.
16125001|NCT01972386|Device|Spectrum Image Analysis using a Linear Array Ultrasound Bronchoscope|
16125002|NCT01972373|Drug|Bevacizumab-IRDye800CW|Intravenous administration of a microdose (4.5mg, subtherapeutic) of Bevacizumab-IRDye800CW prior to the endoscopic procedure
16125003|NCT01972373|Device|NIR fluorescence endoscopy|48-72 hours administration of Bevacizumab-IRDye800CW a flexible NIR fluorescence endoscopy will be performed via the rectum
16125004|NCT01972347|Drug|Dabrafenib|Patients will receive neoadjuvant treatment with dabrafenib 150mg twice a day and trametinib 2mg once a day for 12 weeks. Patients will then have complete lymph node dissection and will continue on maintenance treatment with dabrafenib 150mg twice a day and trametinib 2mg once a day for 40 weeks.
16125005|NCT01972347|Drug|Trametinib|Patients will receive neoadjuvant treatment with dabrafenib 150mg twice a day and trametinib 2mg once a day for 12 weeks. Patients will then have complete lymph node dissection and will continue on maintainance treatment with dabrafenib 150mg twice a day and trametinib 2mg once a day for 40 weeks.
16125006|NCT01972334|Biological|FMT|as explained in study arm
16125007|NCT01972334|Biological|placebo|salt water or saline will be given as placebo
16125008|NCT01972321|Other|Technology supported supervision|"CHWs will be provided with mobile phones and solar chargers to carry out the following:
~Establish closed user groups (CUGs) to enable two-way communication between CHWs and their supervisors free of charge to the users.
~Data submission through mobile phones 2.1. receive motivational performance related feedback provided in response. 2.2. Automated messages to supervisors which 2.2.1. Flags problems and strengths/successes identified in CHWs data 2.2.2. Alerting supervisors as to which CHWs require targeted supervision. 2.3. CHWs data summarised in a user friendly format and made accessible to district statisticians
~Monthly motivational short message service (SMS) messages provided to CHWs that are locally relevant to CHW work and that are designed to impact positively on CHW performance."
16125009|NCT01972321|Behavioral|Community supported supervision|CHWs will facilitate the clubs using a learning, planning and action cycle. Club members will rank child health challenges faced by their community using picture cards and decide which one to focus on for each cycle. They will discuss solutions, which include supporting CHWs services, and take actions to meet challenges. They will also promote group decision-making and ownership and through this process gain tangible results. Solutions to health challenges developed by club members are a key focus of the village health club approach. Village Health Clubs are based on 5 guiding principles: clubs are open to all, village owned, intended to support CHW work, strength based, and fun and focused.
16125010|NCT01972321|Other|Integrated community case management|Implementation of integrated community case management, with provision of training and equipment to CHWs for diagnosis and treatment of malaria, pneumonia and diarrhoea in children less than 5 years of age. Supportive supervision of CHWs will be provided by assigned health facility supervisors.
16125011|NCT01972308|Behavioral|Patient Advocate|Subject works with a Patient Advocate who coaches, models, and assists with preparations for a visit with the asthma doctor; attends the visit with permission of participant and provider; and confirms understanding. The PA facilitates scheduling, obtaining insurance coverage, overcoming patients' unique social and administrative barriers to accomplishing medical advice, and transfer of information between provider and patient.
16125012|NCT01972308|Behavioral|Usual Care|Subjects receive asthma care from their proivders in the participating practices which generally follow asthma guidelines
16125013|NCT01972282|Device|WATCHMAN Left Atrial Appendage Closure|
16125014|NCT01972269|Drug|Bupivacaine-fentanyl|0.125% bupivacaine-fentanyl 5mcg/mL
16125015|NCT01972269|Drug|Lidocaine|2% lidocaine
16125016|NCT01972243|Other|no intervention|
16125017|NCT01972230|Drug|Sevoflurane|
16125018|NCT01972230|Drug|Diprivan + Remifentanil TCI|
16125023|NCT01972204|Behavioral|Intensive adherence instruction|Instruction with educational brochure
16125024|NCT01972204|Behavioral|Control|Instruction as per usual practice
16125025|NCT01972178|Drug|PRC-4016|
16125026|NCT01972178|Drug|Placebo|
16125027|NCT01972178|Drug|Statins|Any statin allowed (i.e. rosuvastatin, simvastatin, pravastatin, atorvastatin etc)
16125028|NCT01972165|Procedure|Mini-incision carpal tunnel release|
16125029|NCT01972165|Procedure|Endoscopic carpal tunnel release|
16125030|NCT01972152|Drug|G-Pen(TM) 1 mg|
16125031|NCT01972152|Drug|Lilly Glucagon(TM) 1 mg|
16125032|NCT01972152|Drug|G-Pen(TM) 0.5 mg|
16125033|NCT01972139|Device|Renal Denervation using the Symplicity Renal Denervation System|Subjects randomized to the renal denervation group underwent angiography and renal denervation.
16125034|NCT01972139|Other|Sham Renal Denervation|Prior to enrollment closure, subjects were treated with sham renal denervation. After enrollment closure, subjects previously enrolled were no longer eligible to cross-over.
16125035|NCT01972139|Device|Renal Angiography|Subjects who met all criteria after the screening period did undergo a renal artery angiogram to evaluate renal artery anatomy. Only subjects with eligible renal artery anatomy were randomized.
16125036|NCT01972113|Dietary Supplement|Placebo-Control|one placebo softgel capsules per day (for 8 weeks) containing no vitamin K2 (menaquinone-7)
16125037|NCT01972113|Dietary Supplement|Low-Dose Vitamin K2 (menaquinone-7; 45 mcg/d)|one 45-mcg vitamin K2 (menaquinone-7) softgel capsule per day and one placebo softgel per day (containing no menaquinone-7) for 8 weeks
16125038|NCT01972113|Dietary Supplement|High-Dose Vitamin K2 (menaquinone-7; 90 mcg/d)|one 90-mcg vitamin K2 (menaquinone-7) softgel capsules per day for 8 weeks
16125039|NCT01972100|Device|Low-level laser therapy (808nm)|Use of low-level laser therapy(LLLT)or placebo-LLLT applied on quadriceps femoris muscles between sets of isokinetic knee flexion-extension exercise
16125040|NCT01972100|Other|isokinetic exercise|
16125041|NCT01972100|Device|Placebo low-level laser therapy|
16125117|NCT01971437|Procedure|Cystodistension & Cystoscopy|Women with refractory OAB receiving Cystoscopy and cystodistension
16125042|NCT01972087|Behavioral|Telephone simulation training|The intervention consists of four 20-minute telephone simulation training sessions over a 4 month period (one session each month). Each 20-minute training session will include 3 simulated 9-1-1 calls, performed by a standardized caller (trained actor) and feedback will be provided right away by a trained observer who takes notes during the simulation calls and discusses the teaching points after the session. In total, the 9-1-1 dispatchers will receive 12 different simulated calls.
16125043|NCT01972074|Drug|Memantine|Capsule
16125044|NCT01972074|Other|Placebo|Capsule
16125045|NCT01972061|Device|Foot stimulation|Foot stimulation electrically activates the somatic afferent nerves in the foot using FDA-approved, commercially available transcutaneous electrical nerve stimulator (TENS) and skin surface electrodes attached to the foot.
16125046|NCT01972048|Behavioral|mMammogram|Text messages delivered via mobile app to participants designed to inform them about breast cancer screening and encourage them to schedule a mammogram.
16125047|NCT01972048|Other|Print brochure|Mailed print brochure about breast cancer screening and community resources.
16125048|NCT01972035|Drug|Valacyclovir|Experimental Arm
16125049|NCT01972035|Drug|Valganciclovir|Standard of care
16125050|NCT01972022|Device|EES SYNERGY™|percutaneous coronary intervention with implantation of Bioabsorbable Polymer EES
16125051|NCT01972022|Device|ZES, RESOLUTE Integrity™|percutaneous coronary intervention using ZES, RESOLUTE Integrity™ coronary stent
16125052|NCT01972009|Procedure|Cardiac catheterisation|Simultaneous measurement of pressure and flow velocity in the pulmonary artery is achieved during right heart catheterisation by passing a catheter as per usual practice into the pulmonary artery, a purpose-designed wire (Combiwire) will then be advanced approximately 1 cm beyond the end of the catheter. The data obtained will be used for wave intensity analysis.
16125053|NCT01971983|Other|High-velocity, low-amplitude (HVLA)|With the subject lying on his/her side, the therapist will rotate the patient's trunk, flex his/her hip and knee of the upper leg. The therapist positions his caudad forearm over the hip, while the cephalad forearm lies over the patient's shoulder. The therapist's hands will be positioned over the lumbar spine's spinous process to be manipulated.
16125054|NCT01971983|Other|Muscle energy (ME)|This technique involves the active movement of the patient to activate a specific musculature in order to move a bony segment of a given joint in a specific direction in relation to the adjacent bone. This technique aims to restore the restricted movement of the joint in question.
16125055|NCT01971983|Other|Sham|Individuals in this group received a sham intervention type, in order to simulate an intervention.
16125056|NCT01971970|Biological|Infliximab|Remission induction in anti-TNF naïve patients will be achieved by administration of 5 mg/kg IFX infusions at week 0, 2 and 6.
16125057|NCT01971970|Biological|Adalimumab|ADA is administered as subcutaneous injections every other week.In children (age below 18 years), remission induction in anti-TNF naïve patients will be achieved by an initial loading dose of 80 mg, followed by 40 mg 2 weeks later. In adults, remission is induced by 160 mg at week 0, followed by 80 mg at week 2
16125058|NCT01971918|Biological|anti drug antibodies dosage|anti drug antibodies dosage
16125059|NCT01971892|Other|Non Invasive ventilation (facial mask and NIV ventilator)|Non invasive ventilation (NIV) which associated pressure support ventilation (PSV: 5 to 15 cmH2O) and positive end expiratory pressure (PEEP: 5 to 10 cmH2O). NIW will be delivered through a facial mask with either NIV ventilator or ICU ventilator with NIV option
16125060|NCT01971892|Other|Standard oxygen therapy with facial mask|facial Venturi mask
16125061|NCT01971879|Procedure|Remote ischemic preconditioning|"A blood pressure cuff is placed on one arm and is inflated to 200mmHg during 5 minutes. During the following 5 minutes, the cuff is inflated at the same pressure on the contralateral arm. This sequence is repeated 3 times, that is to say 3 sequences of cuff inflation for 5 minutes on each arm followed by 5 minutes without inflation.
~The treadmill test starts 5 minutes after the end of the last deflation of the cuff."
16125062|NCT01971879|Procedure|Control|"A blood pressure cuff is placed on one arm and is inflated to 10mmHg during 5 minutes. During the following 5 minutes, the cuff is inflated at the same pressure on the contralateral arm. This sequence is repeated 3 times, that is to say 3 sequences of cuff inflation for 5 minutes on each arm followed by 5 minutes without inflation.
~The treadmill test starts 5 minutes after the end of the last deflation of the cuff."
16125063|NCT01971853|Drug|oral placebo|Ibuprofen placebo and Acetaminophen placebo will be added to a Demerol-Vistaril regimen
16125064|NCT01971853|Drug|Oral Analgesics|Ibuprofen at 5.0 mg/kg and Acetaminophen at 15.0 mg/kg will be added to a Demerol-Vistaril regimen
16125065|NCT01971840|Behavioral|MOVI-KIDS|MOVI-KIDS is a multidimensional intervention that consist of: a) for children, 4.5 h/week of a standardized recreative, non-competitive physical activity extracurricular program; b) informative sessions to parents and teachers about how schoolchildren can became more active, and c) interventions in the playground (environmental changes: equipment, facilities, painting, etc.) aimed to promote physical activity during recess (MOVI-Playground).
16125066|NCT01971827|Behavioral|MOVI-KIDS|MOVI-KIDS is a multidimensional intervention that consist of: a) for children, 4.5 h/week of a standardized recreative, non-competitive physical activity extracurricular program; b) informative sessions to parents and teachers about how schoolchildren can became more active, and c) interventions in the playground (environmental changes: equipment, facilities, painting, etc.) aimed to promote physical activity during recess (MOVI-Playground).
16125067|NCT01971814|Drug|Infliximab|All patients meeting inclusion criteria will receive the infliximab 10mg/kg IV as part of standard care of the hospitalized patient with severe ulcerative colitis at UCSF Medical Center.
16125068|NCT01971801|Dietary Supplement|Vitamin D3 50,000 IU|Capsule given by mouth once a week
16125069|NCT01971801|Other|Placebo|One capsule given by mouth weekly
16125070|NCT01971788|Device|Optical Coherence Tomography of the infarct related artery|
16125071|NCT01971775|Device|Ultrasonically activated Shears|Dissection and lymphovascular sealing with Ultrasonically Activated Shears
16125072|NCT01971775|Device|Conventional Monopolar Electrocautery|Dissection and lymphovascular sealing with Conventional Monopolar Electrocautery
16125073|NCT01971762|Behavioral|Follow recommendations based on scientific evidence to S. aureus bacteremia management|
16125074|NCT01971762|Behavioral|Not to follow recommendations based on scientific evidence to S. aureus bacteremia management|
16125077|NCT01971723|Other|T+ Supplement|Randomized, placebo-controlled, double blind protocol with two treatment groups (matched by lean body mass). Group 1 will receive the recommended serving of one scoop (11g) of T+ supplement. This serving will be taken 45 minutes before the beginning of working out on an empty stomach (>1 hour after meal). On non-training days, the participants will also take a serving at the same time as on training days. This will continue for four weeks (28 days).
16125078|NCT01971723|Other|Placebo|The placebo group will consume a calorie-match placebo in the same manner as the supplement group (one serving 45 minutes prior to work outs on an empty stomach). The placebo group will also follow the same supplementation patterns and workout as their counterparts in the supplement group.
16125079|NCT01971710|Behavioral|Community leader engagement|Community leaders conducting advocacy, community dialogue and community action plans on PMTCT/MCH
16125080|NCT01971710|Behavioral|Community days|The provision of facilitated dialogues, advocacy and education, and selected health services, to a community on a specific day
16125081|NCT01971710|Behavioral|Community Peer Groups|Pregnant women in community peer groups receiving information and education on PMTCT/MCH through 4 weekly peer-led classes . Men in community peer groups receiving information and education on their role in supporting women and families through 4 peer-led education sessions.
16125082|NCT01971684|Drug|Second Line ITP agents|The treating physicians will select the second line agent and clinical data will be collected.
16125083|NCT01971671|Other|no intervention.|
16125084|NCT01971658|Drug|Thalidomide®|
16125085|NCT01971658|Drug|Cyclophosphamide|
16125086|NCT01971658|Drug|Velcade®|
16125087|NCT01971658|Drug|Dexaméthasone|
16125088|NCT01971645|Drug|Dexamethasone|Patients may receive 0.1 mg/kg preservative-free dexamethasone (max. dose 4 mg) either perineurally or intramuscularly.
16125089|NCT01971645|Drug|Ropivacaine|Patients will receive 2 mg/kg of 0.5% ropivacaine (max. dose 100 mg) perineurally.
16125090|NCT01971632|Drug|Oxycodone & naloxone combination, prolonged release|
16125091|NCT01971632|Drug|placebo oxycodone / naloxone|
16125092|NCT01971606|Drug|Rosuvastatin|"Patients will be randomized in a ratio of 1:1 to A) High-dose rosuvastatin vs. B) Placebo.
~A) Rosuvastatin group : Administration of 40mg of rosuvastatin PO 12 hours before surgery and 20mg of rosuvastatin PO 2hours before surgery and 10mg of rosuvastatin PO daily at postoperative period.
~B) Placebo group : Administration of placebo at 12 hours and 2 hours before surgery and 10mg of rosuvastatin PO daily at postoperative period."
16125093|NCT01971593|Drug|Eplerenone|
16125094|NCT01971580|Drug|Ambrisentan|
16125095|NCT01971567|Device|HIRREM|
16125096|NCT01971554|Drug|MK-8666|MK-8666, capsules, oral, QD, Days 1 to 14
16125097|NCT01971554|Drug|Placebo|Placebo, capsules, oral, QD, Days 1 to 14
16125098|NCT01971541|Behavioral|Mindfulness-Based Stress Reduction|A validated 8-week group program that teaches mindfulness meditation
16125099|NCT01971541|Behavioral|Cognitive Processing Therapy|A validated group program of PTSD treatment, which focuses on cognitive processing.
16125100|NCT01971528|Device|Electronic muscle stimulator|Participants will perform 8 weeks of electrical stimulation for Quadriceps muscle belly(30 minutes/time, 3 times/week).
16125101|NCT01971528|Other|Muscle strength training|Participants will perform 8 weeks of isotonic contraction muscle strength training for lower extremities.
16125102|NCT01971515|Drug|MSC2363318A|"Part 1: MSC2363318A will be administered orally once daily for repeated 21-day cycles until intolerable toxicity or disease progression. Additional dose escalations will continue until Maximum Tolerated Dose (MTD) is reached, the food effect will be investigated in a separate group.
~Part 2 (Cohort 1): MSC2363318A will be administered orally once daily for repeated 21-day cycles until intolerable toxicity or disease progression in subjects with PAM pathway alterations.
~Dose reductions or treatment interruptions will be made at the discretion of the Investigator. If treatment interruption is required due to an acute or less severe but intolerable MSC2363318A-related event, at least a 1-week break is recommended. If, at retreatment, the dose reduction is not required, then the continuous daily dosing regimen may be replaced with an intermittent dose regimen of 2 weeks on, 1 week off (i.e. daily dosing from Day 1 to Day 15 followed by no dosing on Day 16 to Day 21 of the cycle)."
16125103|NCT01971515|Drug|MSC2363318A plus Trastuzumab|"Part 2 Cohort 2: MSC2363318A will be administered orally once daily for repeated 21-day cycles in combination with Trastuzumab.
~Dose reductions or treatment interruptions will be made at the discretion of the Investigator. If treatment interruption is required due to an acute or less severe but intolerable MSC2363318A-related event, at least a 1-week break is recommended. If, at retreatment, the dose reduction is not required, then the continuous daily dosing regimen may be replaced with an intermittent dose regimen of 2 weeks on, 1 week off (i.e. daily dosing from Day 1 to Day 15 followed by no dosing on Day 16 to Day 21 of the cycle).
~Trastuzumab is a recombinant IgGI kappa humanized monoclonal antibody administered weekly by intravenous infusion."
16125104|NCT01971515|Drug|MSC2363318A plus Tamoxifen|"Part 2 Cohort 3: MSC2363318A will be administered orally once daily for repeated 21-day cycles in combination with Tamoxifen.
~Dose reductions or treatment interruptions will be made at the discretion of the Investigator. If treatment interruption is required due to an acute or less severe but intolerable MSC2363318A-related event, at least a 1-week break is recommended. If, at retreatment, the dose reduction is not required, then the continuous daily dosing regimen may be replaced with an intermittent dose regimen of 2 weeks on, 1 week off (i.e. daily dosing from Day 1 to Day 15 followed by no dosing on Day 16 to Day 21 of the cycle).
~Tamoxifen is a nonsteroidal antiestrogen administered daily by oral administration."
16125105|NCT01971502|Drug|Placebo to BI 1060469|single rising doses
16125106|NCT01971502|Drug|BI 1060469|food effect
16125107|NCT01971502|Drug|BI 1060469|single rising doses
16125108|NCT01971489|Drug|Buparlisib|Given PO
16125109|NCT01971489|Drug|Cisplatin|Given IV
16125110|NCT01971489|Drug|Gemcitabine Hydrochloride|Given IV
16125111|NCT01971489|Other|Laboratory Biomarker Analysis|Correlative studies
16125112|NCT01971489|Other|Pharmacological Study|Correlative studies
16125113|NCT01971489|Other|Questionnaire Administration|Ancillary studies
16125114|NCT01971476|Drug|volasertib|intravenous administration on day 1of a treatment course
16125115|NCT01971463|Other|Normal saline|intravenous administration of 500cc of 0.9% NaCl over 30 minutes
16125116|NCT01971450|Drug|Iloprost (Ventavis, BAYQ6256)|
16125120|NCT01971411|Drug|Calcium 500mg with 200 IU Vitamin D - 2 tablets daily|
16125121|NCT01971411|Procedure|Blood levels of Vitamin D, Serum CTX, Mg, Ca++ and iPTH|
16125122|NCT01971411|Behavioral|Usual sun exposure documentation|
16125123|NCT01971411|Behavioral|Dietary intake of calcium, vitamin D, magnesium|
16125124|NCT01971398|Behavioral|Positive FASD education brochure|Exposure to a positive FASD education brochure
16125125|NCT01971398|Behavioral|Negative FASD education brochure|Exposure to a negative FASD education brochure
16125126|NCT01971398|Behavioral|Active comparator (a general women's health brochure)|Exposure to a general women's health brochure
16125127|NCT01971385|Drug|Squaric Acid solution|
16125128|NCT01971385|Drug|Placebo solution|
16125129|NCT01971346|Drug|etanercept|100 mg Etanercept injections per week (2 separate single-use pre-filled 50 mg subcutaneous injections taken on two separate days) for 3 months
16125130|NCT01971320|Device|Urostim I stimulation|Urostim I stimulation will be done during meals for 6 weeks
16125131|NCT01971307|Other|SGE-PsyScan|
16125132|NCT01971281|Device|NovoTTF-100L|Patients will be treated continuously with the NovoTTF-100L. TTFields treatment will consist of wearing four electrically insulated electrode arrays on the torso. The treatment enables the patient to maintain regular daily routine.
16125133|NCT01971281|Drug|Gemcitabine|Gemcitabine 1000 mg/m^2 over 30 minute infusion will be administered once weekly for up to 7 weeks (or until toxicity necessitates reducing or holding a dose), followed by a week rest from treatment. Subsequent cycles will consist of once weekly infusions days 1, 8, 15 every 28 days.
16125134|NCT01971281|Drug|nab-Paclitaxel|nab-paclitaxel 125 mg/m^2 administered as an intravenous infusion over 30-40 minutes on days 1, 8 and 15 of each 28-day cycle.
16125135|NCT01971268|Device|Dental Implant|place dental implants according to manufacturer guidelines
16125136|NCT01971268|Device|Platform-Switch Dental Implant|Place Dental Implant with an abutment narrower than the implant platform
16125137|NCT01971268|Device|Platform-Matched dental implant|Place Dental Implant with abutment with same size as the platform
16125138|NCT01971255|Biological|Ca/04/2009/H1N1r Challenge Virus|The human challenge virus will be administered intranasally to each participant using a nasal sprayer. A total volume of up to 1 mL of virus will be administered.
16125139|NCT01971242|Drug|Exenatide|2mg, SC (subcutaneous) once weekly. Number of weeks: 48 weeks. Exenatide is a 39-amino-acid peptide
16125140|NCT01971242|Other|Placebo|Placebo, 2mg, SC (subcutaneous), once weekly for 48 weeks.
16125141|NCT01971229|Other|Carbohydrate based drink|After consumption of the test drink to record the insulin response and gastric emptying.
16125142|NCT01971229|Other|Whey protein based drink|After consumption of the test drink to record the insulin response and gastric emptying.
16125143|NCT01971216|Behavioral|Relaxation|
16125144|NCT01971203|Drug|seroquel xr|Quetiapine target dosage will be 150 mg/day, beginning at 50 mg/day
16125145|NCT01971203|Behavioral|CBT|16 weeks of treatment
16125146|NCT01971190|Drug|Intravitreal Aflibercept injection|"2mg intravitreal Aflibercept(Eylea) injection at baseline, at 1 month, and at 2 month.
~At 3 month, 4 month, 5 month, and 6 month, PRN treatment of aflibercept injection or half-fluence photodynamic therapy may be done, if one of following conditions is fulfilled.
~The PRN treatment method was decided by investigator's discretion.
~Of patient who had persistent intra- or subretina fluid on SD-OCT
~Central subfield thickness is not decreased to more than 50 micrometer compared with baseline central subfield thickness
~Best-corrected ETDRS letter score dose not increased more than 5 letters than baseline (because of the persistent CSC).
~Central subfield thickness is thicker than the previous exam
~BCVA letter score is worse than the previous exam (because of the persistent CSC)"
16125147|NCT01971190|Drug|Sham injection|"Sham injection at baseline, at 1 month, and at 2 month.
~At 3 month, 4 month, 5 month, and 6 month, PRN treatment of aflibercept injection or half-fluence photodynamic therapy may be done, if one of following conditions is fulfilled.
~The PRN treatment method was decided by investigator's discretion.
~Of patient who had persistent intra- or subretina fluid on SD-OCT
~Central subfield thickness is not decreased to more than 50 micrometer compared with baseline central subfield thickness
~Best-corrected ETDRS letter score dose not increased more than 5 letters than baseline (because of the persistent CSC).
~Central subfield thickness is thicker than the previous exam
~BCVA letter score is worse than the previous exam (because of the persistent CSC)"
16125148|NCT01971190|Procedure|Half-fluence photodynamic therapy|"At 3 month, 4 month, 5 month, and 6 month, PRN treatment of aflibercept injection or half-fluence photodynamic therapy may be done, if one of following conditions is fulfilled.
~The PRN treatment method was decided by investigator's discretion.
~Of patient who had persistent intra- or subretina fluid on SD-OCT
~Central subfield thickness is not decreased to more than 50 micrometer compared with baseline central subfield thickness
~Best-corrected ETDRS letter score dose not increased more than 5 letters than baseline (because of the persistent CSC).
~Central subfield thickness is thicker than the previous exam
~BCVA letter score is worse than the previous exam (because of the persistent CSC)"
16125149|NCT01971177|Device|Femtosecond laser cataract surgery|"The VICTUS lens fragmentation procedure is part of the femtosecond laser assisted cataract procedure, which generates precise cuts inside the cataractous lens, leading to a softening and fragmentation of the lens.
~The correct positioning of the cuts inside the lens can be verified by means of an optical coherence tomograph (OCT) before starting the laser assisted fragmentation process.
~Various surgical patterns will be used within this study. For each pattern different geometry/laser parameters can be adjusted individually according to each patient's cataract status.
~All the patients who are enrolled in the laser groups (all cataract grades) will be treated with femtosecond laser assisted capsulotomy before the femtosecond laser assisted lens fragmentation by VICTUS femtosecond laser platform."
16125150|NCT01971177|Procedure|Manual cataract surgery|"Manual: manual group acts as a control group where the lens fragmentation are per-formed manually without femtosecond laser assisted lens fragmentation"
16125151|NCT01971164|Drug|JTZ-951|Subjects will receive JTZ-951 or Placebo
16125152|NCT01971164|Drug|Placebo|
16125153|NCT01971151|Behavioral|Exposure therapy|"Treatment protocol:
~1) preparation consisting of intake and identification of feared movements, activities and situations and their underlying catastrophic beliefs. 2) education, 3)exposure sessions: patients confront threatening situations and behavioral experiments are performed that are targeted at correcting erroneous catastrophic beliefs. 4) homework assignments."
16125155|NCT01971112|Dietary Supplement|Multivitamins and minerals|Dietary supplement Arm X: Vitamins B6, B12,folic acid, A, D, E, and Iron, and copper at one US-RDA. Plus vitamin C 500 mg, and zinc 14 mg will be given orally daily during 52 weeks.
16125156|NCT01971099|Drug|tribulus terrestris|patients will use 750mg/day of tribulus terrestris
16125157|NCT01971099|Other|Placebo|patients will take one pill a day (the same shape of the drug)
16125158|NCT01971073|Device|transcranial direct current stimulation|"arm Participants will receive bilateral anodal-left cathodal-right tDCS or anodal-right cathodal-left tDCS over the DLPFC.
~The following parameters will be used: stimulation intensity of 2 milliAmps for 20 minutes (6 consecutive sessions )."
16125159|NCT01971073|Device|sham tDCS|the sham tDCS group. Neuropsychological testing and symptom ratings will be conducted at baseline and 4 weeks after the end of treatment
16125160|NCT01971060|Device|surgery utilizing V-Loc suture|V-Loc suture will be utilized in the repair of the uterus following removal of fibroid tumors. a second look laparoscopy will be done on all subjects to evaluate scar tissue formation.
16125161|NCT01971047|Drug|Regular Insulin|"Group 1 Treatment Arm,Follow dosing for BG >180 per the following formula:
~Patients with Type 2 Diabetes to receive dosage based on the formula: (BG-120)/30= # units of insulin
~Patients with Type 1 Diabetes to receive dosage based on the formula: (BG-120)/40=# units of insulin
~Patients with Type 1 Diabetes and Type 2 Diabetes over the age of 70 or with chronic kidney disease to receive dosage based on the formula: (BG-120)/50=# units of insulin
~Consider repeating dose if BG>240 mg/dl after 2 hours of initial dose"
16125162|NCT01971047|Drug|Humalog|"Group 2 treatment arm. Follow dosing for Blood glucose > 180, per the following formula:
~Patients with Type 2 Diabetes to receive dosage based on the formula: (BG-120)/30= # units of insulin
~Patients with Type 1 Diabetes to receive dosage based on the formula: (BG-120)/40=# units of insulin
~Patients with Type 1 Diabetes and Type 2 Diabetes over the age of 70 or with chronic kidney disease to receive dosage based on the formula: (BG-120)/50=# units of insulin
~Consider repeating dose if BG>240 mg/dl after 2 hours of initial dose"
16125163|NCT01971034|Drug|Paclitaxel|80 mg/m2, IV, Day 1, Day 8 and Day 15.
16125164|NCT01971034|Drug|Metformin|850mg, PO, every 8 hours, daily.
16125165|NCT01971021|Device|PICC or subcutaneous venous port|
16125166|NCT01971008|Device|Elastic abdominal binder|
16125167|NCT01971008|Device|Placebo binder|
16125168|NCT01970995|Other|THS 2.2 Menthol (mTHS 2.2)|THS 2.2 Menthol ad libitum for 5 days in confinement prolonged by 85 days in an ambulatory setting
16125169|NCT01970995|Other|Smoking Abstinence (SA)|SA for 5 days in confinement prolonged by 85 days in an ambulatory setting
16125170|NCT01970995|Other|Menthol Conventional Cigarette (mCC)|Subject's own preferred brand of mCC ad libitum for 5 days in confinement prolonged by 85 days in an ambulatory setting
16125171|NCT01970982|Other|Tobacco Heating System (THS 2.2)|THS 2.2 ad libitum for 5 days in confinement
16125172|NCT01970982|Other|Smoking abstinence (SA)|SA for 5 days in confinement
16125173|NCT01970982|Other|Conventional cigarette (CC)|Subject's own preferred brand of CC ad libitum for 5 days in confinement
16125174|NCT01970943|Other|Placebo|Placebo will be compared to No Intervention.
16125175|NCT01970930|Procedure|Blood specimen|4 green top tube 40 cc of blood draw
16125176|NCT01970917|Device|Olixia pure eye drops|
16125177|NCT01970917|Device|Placebo|0.9% physiological saline solution
16125178|NCT01970904|Drug|Alisporivir|Alisporivir 100 mg or 200 mg soft gel capsules (SGC) in blister packs for oral administration
16125179|NCT01970904|Drug|Ribavirin|Ribavirin tablets of various strengths for oral administration
16125180|NCT01970904|Drug|Peg-IFNα2a|Peg-IFNα2a solution for subcutaneous injection
16125181|NCT01970891|Device|neuromuscular stimulation device|Effect of neuromuscular stimulation device at specific muscle sites will be examined for freezing of gait amelioration.
16125182|NCT01970878|Drug|GFF MDI (PT 003)|GFF MDI administered as two puffs BID
16125183|NCT01970878|Drug|GP MDI (PT001)|GP MDI administered as two puffs BID
16125184|NCT01970878|Drug|FF MDI (PT005)|FF MDI administered as two puffs BID
16125185|NCT01970878|Drug|Open-label tiotropium bromide inhalation (Spiriva® Handihaler®)|Taken as 1 capsule daily containing 18 μg of open-label tiotropium via the Handihaler dry powder inhaler (DPI)
16125186|NCT01970865|Drug|PF-06463922|Oral, starting dose 10mg once a day, dose escalation in Phase 1 until recommended Phase 2 dose determined, continuous daily dosing, cycles lasting 21 days
16125187|NCT01970865|Drug|Crizotinib|Oral, starting dose of 250 mg BID continuous daily dosing every 21 days
16125188|NCT01970852|Other|Standard tablet computer|No special enhancements or links to personal health information.
16125189|NCT01970852|Other|Enhanced tablet computer|Tablet computer with personalized access to data from the patient's electronic health record.
16125190|NCT01970839|Device|tourniquet, sensory nerve conduction abnormality|
16125191|NCT01970826|Procedure|Single Dental Implants|place single unit dental implants, 2 mm below crestal bone and follow manufacturer guidelines.
16125192|NCT01970826|Procedure|Sterilized Aseptic|Operatory room will be prepared totally aseptic
16125193|NCT01970826|Procedure|Sterilized Clean|Operatory room will be prepared clean but not aseptic
16125194|NCT01970826|Procedure|Full-Mouth Dental Implants|dental implants for full-mouth implant rehabilitation.
16125195|NCT01970826|Procedure|Partial Rehabilitation|two or more implants to support partial rehabilitation
16125196|NCT01970826|Procedure|Duration of Surgery|it will be measure the amount of time to perform the dental implant surgery. It will be measured from the time that the surgeon does the first incision until the last suture is made.
16125197|NCT01970813|Device|acupuncture and bee venom acupuncture point injection|acupuncture and bee venom acupuncture point injection at 10 acupuncture points twice a week for 12 weeks. This intervention is added on to the conventional antiparkinsonian drugs.
16125198|NCT01970813|Device|sham acupuncture and normal saline injections|sham acupuncture and normal saline injections at 10 sham acupuncture points twice a week for 12 weeks. This intervention is added on to the conventional antiparkinsonian drugs.
16125199|NCT01970800|Drug|Growth Hormone|Will obtain daily injections and will evaluate the IGF-1 and IGFBP3 every 3 months
16125200|NCT01970787|Device|Radiofrequency Ablation (RFA) using the HALO Ablation System|
16125201|NCT01970774|Other|MTM with PGx|Patients will attend MTM sessions and receive PGx testing
16125202|NCT01970748|Drug|Propranolol|Propranolol 10mg BID initially and titrate dosage every week to achieve 25% drop of heart rate (keep heart rate>55 or systemic blood pressure>90mmHg)
16125203|NCT01970748|Procedure|Esophageal variceal ligation|Esophageal variceal ligation every 3-4 weeks to achieve variceal eradication under endoscopy
16125204|NCT01970735|Biological|Blood test|
16125205|NCT01970722|Drug|Carboplatin|Given IP or IV
16125206|NCT01970722|Drug|Cisplatin|Given IP
16125207|NCT01970722|Drug|Gemcitabine Hydrochloride|Given IP or IV
16125208|NCT01970722|Other|Laboratory Biomarker Analysis|Correlative studies
16125209|NCT01970722|Drug|Paclitaxel|Given IP or IV
16125210|NCT01970722|Drug|Pegylated Liposomal Doxorubicin Hydrochloride|Given IP or IV
16125211|NCT01970722|Other|Quality-of-Life Assessment|Ancillary studies
16125212|NCT01970722|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16125213|NCT01970683|Dietary Supplement|VSL #3 BID|
16125214|NCT01970657|Biological|No treatment specified|No intervention
16125215|NCT01970657|Biological|No treatment|None specified
16125216|NCT01970644|Radiation|Gamma knife radiosurgery|Depending on maximum tumour diameter, patients will receive a single dose of 15-20 Gy to the isodose surface which encompasses the entire metastasis.
16125217|NCT01970631|Behavioral|Motivational Interviewing (MI)|The motivational interviewing arms of SPARKS will consist of Health Educators trained in Motivational Interviewing (MI) techniques contacting participants at regular intervals over the course of the nine months following participants' total knee replacement (TKR).
16125218|NCT01970631|Other|Financial Incentives|The financial intervention arms of SPARKS will provide compensation to participants for completing physical activity logs weekly/bi-weekly and reaching pre-specified physical activity goals.
16125219|NCT01970618|Drug|RV1162 single dose|Safety and tolerability of single escalating doses
16125220|NCT01970618|Drug|RV1162 matching placebo single dose|Safety and tolerability of single escalating doses
16125221|NCT01970618|Drug|RV1162: 7 day repeat dose|Safety and tolerability of a repeat dose
16125222|NCT01970618|Drug|RV1162 matching placebo: 7 day repeat dose|Safety and tolerability of a repeat dose
16125223|NCT01970618|Drug|RV1162: 14 day repeat dose|Safety and tolerability of repeat escalating doses
16125224|NCT01970618|Drug|RV1162 matching placebo: 14 day repeat dose|Safety and tolerability of repeat escalating doses
16125225|NCT01970605|Procedure|Surgical reconstruction|"In contrast to silver acetate impregnated vascular graft, Silver Graft can be immersed in an antibiotic containing solution prior to implantation. This practice should always be followed according to each participant's hospital guidelines and experience. The long term efficacy of the metallic silver coating will not be reduced.
~Common practice antibiotic co-medication before, during and after surgery needs to be documented but is at the discretion of each participating institution.
~Due to the registry character of this assessment, i.e. routine use of the investigational product, local antibiotics, e.g. dipping of the vascular graft into a rifampin solution is permissible."
16125226|NCT01970592|Behavioral|POWER training|Individuals with chronic post-stroke hemiparesis will undergo training to improve muscle power generation for 24 sessions (3 times/week) that includes both resistive and task-specific elements. Session duration will be ~90 minutes/day (inclusive of rest intervals). Training will include five distinct resistance activities aimed at improving muscle power-- each previously reported to contribute to improved walking
16125227|NCT01970579|Device|Paclitaxel coated balloon|"Treatment of target lesion with study balloon (coated). Diameter of treatment balloon = RVD
~Each study balloon must only be used once (except postdilatation is necessary which may be done with the same balloon used for the initial dilatation)
~Treatment balloon must be 20 mm longer than lesion length (to assure balloon overlap of 10 mm proximal and distal to lesion)
~If two treatment balloons are necessary overlap between the balloon must be 10 mm
~Inflation pressure 7-10 atm
~Intraluminal defects or haziness should be treated with additional inflations and/or aggressive anti-platelet agents or bailout stenting"
16125228|NCT01970579|Device|uncoated PTA catheter|"Treatment of target lesion with study balloon (uncoated). Diameter of treatment balloon = RVD
~Each study balloon must only be used once (except postdilatation is necessary which may be done with the same balloon used for the initial dilatation)
~Treatment balloon must be 20 mm longer than lesion length (to assure balloon overlap of 10 mm proximal and distal to lesion)
~If two treatment balloons are necessary overlap between the balloon must be 10 mm
~Inflation pressure 7-10 atm
~Intraluminal defects or haziness should be treated with additional inflations and/or aggressive anti-platelet agents or bailout stenting."
16125229|NCT01970566|Other|Behavioral and Drug|Topiramate-Phentermine plus cognitive behavioral therapy
16125230|NCT01970566|Other|Behavioral|Intense Exercise/Moderate Calorie Restriction
16125231|NCT01970566|Other|Behavioral and Drug|Topiramate-Phentermine plus cognitive behavioral therapy
16125232|NCT01970566|Other|Behavioral|Intense Exercise/Moderate Calorie Restriction
16125233|NCT01970553|Drug|lurbinectedin (PM01183)|lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials
16125234|NCT01970553|Drug|Gemcitabine|1000 mg vial, powder for injectable solution
16125235|NCT01970540|Drug|lurbinectedin (PM01183)|lurbinectedin (PM01183) is presented as powder for concentrate for solution for infusion with two strengths, 1-mg and 4-mg vials.
16125236|NCT01970540|Drug|Doxorubicin|Commercially available presentations of vials containing doxorubicin will be provided as appropriate.
16125237|NCT01970527|Biological|Ipilimumab|Given IV
16125238|NCT01970527|Other|Laboratory Biomarker Analysis|Correlative studies
16125239|NCT01970527|Other|Pharmacological Study|Correlative studies
16125240|NCT01970527|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
16125241|NCT01970514|Device|ARO Spinal System|The device provides an internal axial rotation orthosis (ARO) for patients being surgically treated for herniated nucleus pulposus (HNP).
16125242|NCT01970501|Drug|bucindolol hydrochloride|
16125243|NCT01970501|Drug|metoprolol succinate|
16125244|NCT01970501|Other|Placebo oral capsule|
16125245|NCT01970488|Biological|Adalimumab|Administered by subcutaneous injection
16125246|NCT01970488|Biological|ABP 501|Administered by subcutaneous injection
16125247|NCT01970475|Biological|ABP 501|Solution for subcutaneous injection in pre-filled syringe
16125248|NCT01970475|Biological|Adalimumab|Solution for subcutaneous injection in pre-filled syringe
16125249|NCT01970462|Drug|Sitagliptin|Sitagliptin prior to hospital discharge and 6 weeks following discharge.
16125250|NCT01970462|Drug|Placebo|Patients are reandomized to Sitagliptin or placebo for 6 weeks post-operatively
16125251|NCT01970449|Biological|DNA Nat-B env vaccine|The DNA Nat-B env vaccine will be administered as a 4-mg dose injection intramuscularly (IM) by Biojector 2000 ® in the deltoid muscle of the non-dominant arm (unless medically contraindicated).
16125252|NCT01970449|Biological|NYVAC Nat-B env vaccine|NVYAC Nat-B env vaccine will be administered as a 3 × 10^7 plaque forming units (pfu) dose IM by needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated).
16125253|NCT01970449|Biological|DNA CON-S env vaccine|The DNA CON-S env vaccine will be administered as a 4-mg dose injection IM by Biojector 2000 ® in the deltoid muscle of the non-dominant arm (unless medically contraindicated).
16125254|NCT01970449|Biological|NYVAC CON-S env vaccine|NVYAC CON-S env vaccine will be administered as a 3 × 10^7 pfu dose IM by needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated).
16125255|NCT01970449|Biological|DNA Mosaic env vaccine|The DNA Mosaic env vaccine will be administered as a 4-mg dose injection IM by Biojector 2000 ® in the deltoid muscle of the non-dominant arm (unless medically contraindicated).
16125256|NCT01970449|Biological|NYVAC Mosaic env vaccine|NVYAC Mosaic env vaccine will be administered as a 3 × 10^7 pfu dose IM by needle and syringe in the deltoid muscle of the non-dominant arm (unless medically contraindicated).
16125257|NCT01970449|Biological|Placebo|Placebo for both DNA and NYVAC vaccines will be administered in the deltoid muscle of the non-dominant arm (unless medically contraindicated) as sodium chloride for injection, 0.9%.
16125258|NCT01970449|Device|Biojector 2000® Needle-Free Injection Management System™ (Biojector 2000®)|All three DNA env vaccines will be administered IM in the deltoid muscle of the non-dominant arm (unless medically contraindicated) using the Biojector 2000® device.
16125259|NCT01970436|Other|Remote Prenatal Care|Remote Prenatal Care using a combination of in-person and telemedicine prenatal care visits.
16125260|NCT01970423|Device|CRT|The new device is the first CRT-P that relies on a physiological parameter, respiration, to allow the pacemaker to follow the patient's breath and help create an appropriate pacing rate.
16125261|NCT01970423|Device|conventional right ventricular stimulation|
16125262|NCT01970410|Drug|teriflunomide|14 mg oral teriflunomide daily
16125263|NCT01970397|Device|JUVEDERM® Ultra XC|Up to 3.0 mLs JUVEDERM® Ultra XC injected into the mid to deep dermis (2.0 mLs for initial treatment and 1.0 mL for touch-up treatment).
16125264|NCT01970397|Device|Belotero Balance®|Up to 3.0 mLs Belotero Balance® injected into the mid to deep dermis (2.0 mLs for initial treatment and 1.0 mL for touch-up treatment).
16125265|NCT01970384|Device|Transcranial direct current stimulation|20 Minutes of transcranial direct current stimulation (20 min, 1 mA) administered over the contralesional cortical swallow motor area once daily over 4 consecutive days. In case of a brainstem stroke stimulation will be applied over the cortical swallow motor area of the right hemisphere.
16125266|NCT01970384|Device|Sham stimulation|20 Minutes of sham transcranial direct current stimulation (20 min, no current applied) administered over the contralesional cortical swallow motor area once daily over 4 consecutive days. In case of a brainstem stroke sham stimulation will be applied over the cortical swallow motor area of the right hemisphere.
16125267|NCT01970371|Drug|plazomicin|
16125268|NCT01970371|Drug|colistin|
16125269|NCT01970371|Drug|meropenem|
16125270|NCT01970371|Drug|tigecycline|
16125271|NCT01970371|Drug|antibiotic of Investigator's choice|
16125272|NCT01970358|Biological|Poly-ICLC|
16125273|NCT01970358|Biological|Peptides|
16125274|NCT01970345|Drug|IGF-1|IGF-1 is an FDA-approved (IND exemption #113450), commercially available compound that crosses the blood-brain barrier and has beneficial effects on synaptic development by promoting neuronal cell survival, synaptic maturation, and synaptic plasticity.
16125275|NCT01970345|Drug|Placebo/saline|Placebo
16125276|NCT01970332|Procedure|Revascularization Surgery|
16125277|NCT01970332|Other|Supervised exercise therapy|
16125278|NCT01970306|Device|MatriStem PSM|All esophageal anastomoses will be reinforced circumferentially with ACell MatriStem PSM.
16125279|NCT01970293|Other|Introduction to AA volunteer|In-person, in jail introduction to an AA volunteer, who will offer assistance in attending 2 AA meetings.
16125280|NCT01970280|Drug|Enoxaparin|
16125281|NCT01970267|Procedure|Laser Ablation of Floaters|
16125282|NCT01970267|Procedure|Sham Laser Treatment|Laser will be set at 0.3 millijoules (mJ). There will be a 100% absorptive filter (black spot) of about 1cm placed centrally on the lens. All laser aiming beams will be placed within the 1cm filter. Laser will be applied at 0.3 mJ at the absorptive black spot (100% density filter) in order to create a realistic treatment therapy procedure.
16125283|NCT01970254|Other|Hepatitis B Screening|Undergo 3 HBV screening tests (HbsAg, anti-HBc, and anti-HBs)
16125284|NCT01970254|Other|Survey Administration|Ancillary studies
16125285|NCT01970241|Drug|NPH|NPH given per study table based on steroid dose and patient weight in kg.
16125286|NCT01970241|Drug|Correction Factor|Given at 2 units per 50 mg/dl over 200 mg/dl and increased to 3 units/50 mg/dl over 200 if glucose rises to over 300 mg/dl. Administered qid during study duration.
16125287|NCT01970228|Diagnostic Test|68Ga-citrate and 18F-FDG PET/CT imaging|Single-day study of the two PET tracers
16125288|NCT01970215|Drug|TA-8995|
16125289|NCT01970215|Drug|Atorvastatin|
16125290|NCT01970215|Drug|Rosuvastatin|
16125291|NCT01970215|Drug|TA-8995 0mg (placebo)|
16125292|NCT01970215|Drug|Placebo Statin|
16125293|NCT01970202|Drug|40mg Enoxaparin|Patients with obesity undergoing laparoscopic sleeve gastrectomy, will receive 40mg Enoxaparin per day for 3 days after surgery by subcutaneous administration.
16125294|NCT01970202|Drug|60mg Enoxaparin|Patients with obesity undergoing laparoscopic sleeve gastrectomy, will receive 60mg Enoxaparin per day for 3 days after surgery by subcutaneous administration.
16125295|NCT01970202|Other|Control|no treatment
16125403|NCT01969578|Drug|Carboplatin + Paclitaxel|
16125404|NCT01969565|Drug|Carfilzomib|
16125296|NCT01970176|Drug|Tadalafil|Tadalafil 5 mg tablet. Daily. Tadalafil dose varies from 5 mg to 20 mg for 12 weeks. If blood pressure is >95 then subject dismissed from the Clinical Research Unit (CRU) on 2 (5 mg) tabs of tadalafil or placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tab of Tadalafil. At 2 weeks (± 5 days) if blood pressure is> 100 than add 1 (5 mg) tab of Tadalafil to make a total of 3 (5mg) tabs of Tadalafil. At 4 weeks(± 5 days) if blood pressure is > 100 add 1 (5 mg) tab to make a total of 4 (5 mg) tablets of Tadalafil.
16125297|NCT01970176|Drug|Placebo|Placebo tablet. Daily. Placebo tablets made to match appearance of 5mg Tadalafil tablets. Placebo dose varies from 5 mg to 20 mg (1 to 4 tablets) for 12 weeks. If blood pressure is >95 then subject dismissed from CRU on 2 tabs of placebo. If blood pressure is between 90 - 95 mmHg systolic, then dismiss on 1 (5 mg) tablet of placebo. At 2 weeks (± 5 days) if blood pressure is> 100 than add 1 tab of placebo to make a total of 3 tablets of placebo. At 4 weeks(± 5 days) if blood pressure is > 100 add 1 (5 mg) tab to make a total of 4 tablets of placebo.
16125298|NCT01970163|Other|DermACELL|Acellular dermal matrix is applied at Baseline visit. The study product may be reapplied an additional time (between Weeks 2 and 12 for venous stasis ulcers and between Weeks 3 and 12 for diabetic foot ulcers).
16125299|NCT01970163|Other|GraftJacket|Acellular dermal matrix applied at Baseline visit. May be reapplied one additional time during study (between Week 2 and 12 for venous stasis ulcers and Week 3 and 12 for diabetic foot ulcers).
16125300|NCT01970163|Other|Conventional Care Dressings|"Depending on the state of the wound (dry or moist), different types of nonadherent dressings would be utilized as the primary dressing:
~If the wound is dry, a nonadherent dressing, such an oil emulsion dressing, may be appropriate, as these dressings tend to donate moisture to the wound.
~Hydrogels can also be used if the wound is in need of moisture.
~For a wound that is more moist, a more absorptive dressing may be more appropriate to help reduce potential for maceration.
~A secondary dressing may be desired to add either loft or cushion."
16125301|NCT01970150|Device|rTMS real|
16125302|NCT01970137|Drug|KPS-0373, High dose|
16125303|NCT01970137|Drug|KPS-0373, Low dose|
16125304|NCT01970124|Drug|KPS-0373, High dose|
16125305|NCT01970124|Drug|KPS-0373, Low dose|
16125306|NCT01970111|Drug|KPS-0373, High dose|
16125307|NCT01970111|Drug|KPS-0373, Low dose|
16125308|NCT01970098|Drug|KPS-0373, High dose|28 weeks
16125309|NCT01970098|Drug|KPS-0373, Low dose|28 weeks
16125310|NCT01970098|Drug|Placebo|28 weeks
16125311|NCT01970072|Drug|Remimazolam Tosylate|
16125312|NCT01970072|Drug|Midazolam|
16125313|NCT01970059|Drug|Extended-Release Carvedilol Sulfate|
16125314|NCT01970059|Drug|Sustained-release Metoprolol Succinate|
16125315|NCT01970046|Drug|Placebo/Metformin|"Run in period ：placebo and metformin 500 mg t.i.d for 6 weeks
~Phase A : Placebo and metformin 500 mg t.i.d for 24 weeks
~Phase B : SP2086 50 mg b.i.d and metformin 500 mg t.i.d for 28 weeks"
16125316|NCT01970046|Drug|SP2086 50 mg b.i.d/Metformin|"Run-in period: placebo and Metformin 500 mg t.i.d for 6weeks
~Phase A:SP2086 50 mg b.i.d and Metformin 500 mg t.i.d for 24 weeks
~Phase B:SP2086 50 mg b.i.d and Metformin 500 mg t.i.d for 28 weeks"
16125317|NCT01970046|Drug|SP2086 50 mg q.d./Metformin|"Run-in period: placebo and Metformin 500 mg t.i.d for 6 weeks
~Phase A:SP2086 50 mg q.d and Metformin 500 mg t.i.d for 24 weeks
~Phase B:SP2086 50 mg q.d and Metformin 500 mg t.i.d for 28 weeks"
16125318|NCT01970033|Drug|Placebo|"Run in period ：oral tablets of Placebo twice daily for 2 weeks
~Phase A : oral tablets of Placebo twice daily for 24 weeks
~Phase B : SP2086 50 mg b.i.d or SP2086 100 mg q.d. for 28 weeks"
16125319|NCT01970033|Drug|SP2086 50 mg b.i.d.|"Run-in period: placebo twice daily for 2 weeks
~Phase A:SP2086 50 mg b.i.d for 24 weeks
~Phase B:SP2086 50 mg b.i.d for 28 weeks"
16125320|NCT01970033|Drug|SP2086 100 mg q.d.|"Run-in period:placebo twice daily for 2 weeks
~Phase A: SP2086 100 mg q.d. for 24 weeks
~Phase B: SP2086 100 mg q.d. for 28 weeks"
16125321|NCT01970020|Drug|JNJ-38518168|Following an at least 10-hour overnight fast, participants will receive a single dose containing 30 mg of 14C JNJ-38518168 given as an oral solution on Day 1
16125322|NCT01970007|Device|Zilver Vena Venous Self-Expanding Stent|stenting
16125323|NCT01969994|Other|Controlled dietary background|Controlled dietary flavanol-/procyanidin- background, consisting of daily intake for 14 days (day -17 to -4) of a commercially available flavanol-/procyanidin-containing cocoa-based drink (250 mg cocoa flavanols; 40 mg of (-)-epicatechin) followed by a 4-day period (day -4 to 0) of a low-flavanol diet.
16125324|NCT01969994|Other|(-)-[2-14C]epicatechin intake|Single oral intake of an aqueous solution of a mixture of non-radiolabeled (-)-epicatechin and a single-carbon-14 radiolabeled (-)-[2-14C]epicatechin. The target amount of EC delivered with test drink will be 60 mg, 58.5 mg of which consist of non-radiolabled EC and 1.54 mg (300 µCi) consist of (-)-[2-14C]epicatechin.
16125325|NCT01969981|Procedure|PICC placement with Sherlock 3CG|
16125326|NCT01969968|Other|Lipophilic Organic Polluants dosage|Urinary, blood and fat dosage of Lipophilic Organic Polluants
16125327|NCT01969955|Drug|nanoparticle albumin-bound paclitaxel|Nanoparticle albumin-bound paclitaxel is given at 130 mg/m2 intravenously on day 1 and 8, every 21 days.
16125328|NCT01969942|Biological|allogeneic stem cell transplantation|
16125329|NCT01969942|Drug|Clyclophosphamide|
16125330|NCT01969942|Drug|Fludarabina|
16125331|NCT01969942|Drug|Busulfan|
16125332|NCT01969942|Drug|Melphalan|
16125333|NCT01969929|Procedure|20G Vitrectomy|
16125334|NCT01969929|Procedure|23G vitrectomy|
16125335|NCT01969916|Drug|Regadenoson|Patients will be given a single dose of Lexiscan (0.4 mg, iv bolus)
16125336|NCT01969903|Drug|Precedex injection|
16125337|NCT01969890|Drug|G-CSF administration|Zarzio - 5 microg/kg bis in die for 6 days
16125338|NCT01969877|Drug|cetuximab|
16125339|NCT01969877|Drug|cisplatin|
16125340|NCT01969864|Behavioral|HRSA Video Intervention|
16125341|NCT01969864|Behavioral|PI Video Intervention|
16125342|NCT01969864|Behavioral|CDC Health Website Intervention|
16125400|NCT01969591|Other|conventional postoperative surgery|Patients with colorectal cancer will undergo laparoscopic colorectal resection, and will be divided into two groups. Protocols for fast-track group includes skipping preoperative mechanical bowel preparation, early restoration of diet and early postoperative ambulation.
16125343|NCT01969851|Drug|Lacosamide|"Oral intake twice daily of tablet (100 mg or 50 mg) or syrup formulation (10 mg/ml).
~Total daily dose will be titrated over a period of 6 weeks with starting dose of 100 mg/day or 2 mg/kg/day up to doses not exceeding 600 mg/day or 12 mg/kg/day tablet or syrup, respectively. Followed by a 12 week maintenance period with stable dosing of at least 200 mg/day or 4 mg/kg/day tablet or syrup, respectively."
16125344|NCT01969838|Drug|Momelotinib|Momelotinib tablet administered orally once daily
16125345|NCT01969838|Drug|Ruxolitinib|Ruxolitinib tablets administered orally twice daily
16125346|NCT01969838|Drug|Placebo to match momelotinib|Placebo to match momelotinib tablets administered orally once daily
16125347|NCT01969838|Drug|Placebo to match ruxolitinib|Placebo to match ruxolitinib tablets administered orally twice daily
16125348|NCT01969825|Behavioral|Massage|
16125349|NCT01969812|Device|Evie Slow-release Insemination Device|
16125350|NCT01969812|Other|Traditional Intrauterine Insemination|
16125351|NCT01969799|Drug|Amikacin fosfomycin inhalation solution|300 mg of amikacin and 120 mg of fosfomycin twice daily for 10 days to be administered by aerosol via the eFlow Inline System
16125352|NCT01969799|Drug|Aerosolized placebo|Placebo twice daily for 10 days to be administered by aerosol the eFlow Inline System
16125353|NCT01969786|Other|Corneal ulcer prevention program|The corneal ulcer prevention intervention consists of training female community health volunteers to diagnose corneal abrasions and to treat the abrasions with 1% itraconazole and 1% chloramphenicol ointments 3 times a day for 3 days.
16125354|NCT01969773|Drug|Botulinum toxin A|Patients will be randomly assigned to receive intravesical injection of 100U of BoNT-A (BOTOX, Allergan, Irvine, CA, USA)
16125355|NCT01969773|Drug|Normal saline instillation|Patients will be randomly assigned to receive intravesical injection of injection with normal saline.
16125356|NCT01969760|Behavioral|Healthy Families DC Program|A tailored family-based intervention for health promotion goal setting, substance use prevention, and promotion of physical activity
16125357|NCT01969747|Drug|Empagliflozin medium placebo|Empagliflozin medium placebo
16125358|NCT01969747|Drug|Empagliflozin low placebo|Empagliflozin low placebo
16125359|NCT01969747|Drug|Empagliflozin low placebo|Empagliflozin low placebo
16125360|NCT01969747|Drug|Empagliflozin high placebo|Empagliflozin high placebo
16125361|NCT01969747|Drug|Empagliflozin medium|Empagliflozin medium
16125362|NCT01969747|Drug|Empagliflozin medium placebo|Empagliflozin medium placebo
16125363|NCT01969747|Drug|Empagliflozin high placebo|Empagliflozin high placebo
16125364|NCT01969747|Drug|Empagliflozin high placebo|Empagliflozin high placebo
16125365|NCT01969747|Drug|Empagliflozin medium placebo|Empagliflozin medium placebo
16125366|NCT01969747|Drug|Empagliflozin low placebo|Empagliflozin low placebo
16125367|NCT01969747|Drug|Empagliflozin low|Empagliflozin low
16125368|NCT01969747|Drug|Empagliflozin high|Empagliflozin high
16125369|NCT01969734|Device|Zephyr endobronchial valve placement|
16125370|NCT01969721|Drug|fluticasone propionate|low dose
16125371|NCT01969721|Drug|salmeterol|
16125372|NCT01969721|Drug|placebo|placebo/dummy for blinding purposes
16125373|NCT01969721|Drug|placebo|placebo/dummy for blinding purposes
16125374|NCT01969721|Drug|tiotropium|tiotropium high dose
16125375|NCT01969721|Drug|olodaterol|
16125376|NCT01969721|Drug|olodaterol|
16125377|NCT01969721|Drug|placebo|placebo/dummy for blinding purposes
16125378|NCT01969721|Drug|placebo|placebo/dummy for blinding purposes
16125379|NCT01969721|Drug|tiotropium|tiotropium low dose
16125380|NCT01969721|Drug|fluticasone propionate|low dose
16125381|NCT01969721|Drug|salmeterol|
16125382|NCT01969708|Drug|aflibercept|
16125383|NCT01969708|Drug|bevacizumab|
16125384|NCT01969695|Drug|ABT-199|ABT-199 continuous once daily dosing
16125385|NCT01969682|Drug|ABT-199|Subjects will be dosed with ABT-199, then dosed with ABT-199 in combination with rifampin
16125386|NCT01969682|Drug|Rifampin|Subjects will be dosed with ABT-199, then dosed with ABT-199 in combination with rifampin
16125387|NCT01969669|Drug|ABT-199|Subjects will be dosed with ABT-199, then dosed with ABT-199 in combination with ketoconazole
16125388|NCT01969669|Drug|Ketoconazole|Subjects will be dosed with ABT-199, then dosed with ABT-199 in combination with ketoconazole
16125389|NCT01969656|Drug|2MD|
16125390|NCT01969656|Drug|Calcitriol|
16125391|NCT01969656|Drug|Placebo|
16125394|NCT01969630|Device|PEB|Paclitaxel eluting balloon angioplasty plus provisional nitinol stent implantation
16125395|NCT01969630|Device|PES|Systematic Paclitaxel eluting stent angioplasty
16125396|NCT01969617|Drug|Nalmefene 18 mg, then placebo|One single oral dose Nalmefene on Day 1 and Placebo on Day 8
16125397|NCT01969617|Drug|Placebo, then Nalmefene 18 mg|One single oral dose Placebo on Day 1 and Nalmefene on Day 8
16125398|NCT01969604|Behavioral|Motivational Lifestyle Counselling|"The intervention will focus on individual goal setting and self-efficacy, where participants describe their everyday life in terms of sitting time and set goals how to reduce their daily sitting time. Project staff will introduce the patients to the possible benefits of reducing their daily sitting time.
~The intervention focuses on 4 key messages or themes, which are written in booklets that will be handed to the patients: 1) Reduce daily TV-viewing, 2) Substitute sitting with standing when possible, 3) Break up prolonged sitting and 4) Maximum 30 minutes of sitting.
~Based on the patients' own individually goals the patients decide how many weekly SMS reminders they want to receive during the 16-week intervention period.Example:
~• Hello X. Raise from your table stand-up and allow gravity to assist your lunch to digest. Bonus: You burn more energy when you stand."
16125399|NCT01969591|Procedure|fast-track surgery|Patients with colorectal cancer will undergo laparoscopic colorectal resection, and will be divided into two groups. Protocols for fast-track group includes skipping preoperative mechanical bowel preparation, early restoration of diet and early postoperative ambulation.
16125401|NCT01969578|Drug|bicalutamide + triptorelin|
16125406|NCT01969539|Drug|Combivent Respimat via tee adapter|Patients (all); previously intubated and ventilated; in need of bronchodilation w/CVT-R via tee adapter
16125407|NCT01969539|Drug|Combivent Respimat via ventilator adapter|Patients (all); previously intubated and ventilated; in need of bronchodilation w/CVT-R via ventilator adapter
16125408|NCT01969526|Other|Multifactorial intervention|Intervention consists in three different actions on frailty dimensions, applied to each subject in the intervention group, in groups of 15 participants: rehabilitative therapy and physical exercise plus intake of hyperproteic shakes, memory workshop and review of the medication.
16125409|NCT01969513|Procedure|PROCEDURE: EPLEY MANOEUVRE|The procedure involves a series of four movements of the head and body from sitting to lying, rolling over and back to sitting.
16125410|NCT01969513|Procedure|PROCEDURE: SHAM MANOEUVRE|Placebo manoeuvre is performed with the patient lying down over the affected side for 5 minutes as it is described in similar studies.
16125411|NCT01969500|Behavioral|Mobile Application|
16125412|NCT01969500|Behavioral|Treatment as Usual (TAU)|
16125413|NCT01969487|Other|Preoperative warm-up on simulator|
16125414|NCT01969474|Drug|Cannabis|Cannabis capsules given once daily for a month
16125415|NCT01969474|Drug|Placebo|Placebo
16125416|NCT01969461|Behavioral|Motivational Enhancement Therapy (MET)|The 4-session MET intervention will address alcohol use and HIV medication (ART) adherence. Sessions will be delivered in the clinic or the home by a CHW (outreach worker, etc) already providing services in the clinic. In sessions 1 and 2 (each behavior will get its own session), CHW will elicit the client's view of the problem using MI techniques, building motivation for change by eliciting and reinforcing change talk. The CHW will deliver feedback and discuss the consideration of a behavior change plan option, and the client sets the change plan goal and consolidates commitment. In the last two sessions, the CHW will review the change plan, continue to elicit and reinforce change talk, problem-solve barriers, consolidate commitment, and consider strategies to maintain behavior change.
16125417|NCT01969448|Procedure|Inframammary Fold Incision or Lateral Radial Incision|
16125418|NCT01969448|Procedure|Lateral Radial Incision|
16125419|NCT01969448|Procedure|Inframammary Fold Incision|
16125420|NCT01969448|Device|Laser-assisted fluorescence angiography|
16125421|NCT01969448|Drug|Indocyanine Green|
16125422|NCT01969435|Drug|Carmustine|
16125423|NCT01969435|Drug|Etoposide phosphate|
16125424|NCT01969435|Drug|Cytarabine|
16125425|NCT01969435|Drug|Melphalan HCl (propylene glycol-free)|
16125426|NCT01969422|Procedure|observation|intervention is the contact with online question answering serice ad subseudd
16125427|NCT01969409|Drug|Rituximab|i.v. rituximab given on two occasions 14 days apart.
16125428|NCT01969409|Drug|Placebo|Subjects randomized to placebo will receive two i.v. doses of 5% dextrose in water (D5W) in the same schedule as the rituximab subjects. The D5W and rituximab preparations will be indistinguishable.
16125429|NCT01969396|Device|SonoBiopsy Catheter|Catheter utilized in dual role: sonohysterography and endometrial biopsy
16125430|NCT01969396|Device|Endometrial biopsy catheter|Endometrial sample obtained without the assistance of sonohysterography
16125431|NCT01969383|Other|Heated pool training|
16125432|NCT01969370|Behavioral|Experimental|Option to request non-medically actionable incidental information (after receiving education about them)
16125433|NCT01969357|Drug|Placebo|Tablets(n=4),once daily for 84 days
16125434|NCT01969357|Drug|50 mg SP2086|Tablets(n=1),50mg strength+tablets(n=3) 0 mg once daily for 84 days
16125435|NCT01969357|Drug|100 mg SP2086|Tablets(n=1),100 mg strength+tablets(n=3) once 0 mg daily for 84 days
16125436|NCT01969357|Drug|200 mg SP2086|Tablets(n=2),100 mg strength+tablets(n=2) 0mg once daily for 84 days
16125437|NCT01969357|Drug|100 mg Sitagliptin|Tablets(n=1),100 mg strength+tablets(n=3),0 mg strength once daily for 84 days
16125438|NCT01969331|Dietary Supplement|Normia|One capsule twice a day/14 days
16125439|NCT01969331|Dietary Supplement|Placebo|maltodextrin, microcrystalline cellulose; hypromellose, silicium dioxide (E551), magnesium stearate, colouring agent: titanium dioxide ( E171)
16125440|NCT01969318|Drug|Placebo /Metformin|Patients are administered oral tablets of placebo once daily and metformin 500 mg t.i.d for 2 weeks at run-in period.After randomized,patients will be administered the drugs too
16125441|NCT01969318|Drug|SP2086(50 mg q.d.)/Metformin|patients are administered oral placebo once daily and metformin 500 mg t.i.d for 2 weeks at the run-in period .After randomized ,patients will be administered SP2086 50 mg q.d. and 500 mg t.i.d for 12 weeks
16125442|NCT01969318|Drug|SP2086 (100 mg q.d.)/Metformin|patients are administered oral placebo once daily and metformin 500 mg t.i.d for 2 weeks at the run-in period .After randomized ,patients will be administered SP2086 100 mg q.d. and 500 mg t.i.d for 12 weeks
16125443|NCT01969305|Behavioral|Kazakhstani Family Together|Adolescent-caregiver pairs will receive three 45-minute interactive multi-media sessions with avatars customized to participants' gender that will focus on risk reduction self-efficacy, resistance to peer pressure, decision-making skills and caregiver-adolescent communication, support and monitoring to strengthen youth's relationships with caregivers and reduce youth's risks of drug use and sexual risk behaviors. Through the multimedia tool, participants will confront a series of sexual risks and substance use related situations and will practice their listening, empathy, assertiveness, refusal, and other interpersonal skills. Each caregiver-youth pair will work jointly and engage in discussions, exercises, and behavioral rehearsal as directed by the program.
16125444|NCT01969305|Behavioral|Usual Care Alone|"Adolescents from both study arms will receive the usual care, a health education program about how to prevent drug use and HIV/STIs (sexually transmitted infections). The health education curriculum is delivered in a group format by trained peer educators and outreach workers. The curriculum consists of three 45-minute sessions that include lectures and interactive quizzes about drugs and HIV. These three sessions include information on the following topics:
~Facts and Myth about HIV. HIV/STIs modes of transmission;
~Prevention of HIV. Abstinence and Safe Sex. Attitudes and values about sexuality, sexual risk behaviors, and condom use;
~Knowledge, attitudes and beliefs about drinking and drug use. Risks and consequences of drug use."
16125445|NCT01969292|Other|Colometer|Real time software based image analysis tool.
16125446|NCT01969292|Other|Sham Software|Software that displays constant positive feedback that is unrelated to the quality measures of the actual colonoscopy.
16125447|NCT01969266|Drug|Treatment A: PCI-32765|840 mg capsule formulation administered by mouth on Day 1
16125448|NCT01969266|Drug|Treatment B: PCI-32765|840 mg solution formulation administered by mouth on Day 1
16125449|NCT01969240|Other|Chest Pain Choice Decision Aid|The clinician will review the decision aid with the patient. The decision aid will be used as a tool to facilitate discussion and educate the patient regarding the rationale for their evaluation up to that point in the emergency department visit and their individual risk for a heart attack or pre-heart attack. The clinician will provide the patient with management options consistent with both the patient's values and preferences and the clinician's level of comfort.
16125450|NCT01969227|Drug|Subanesthetic ketamine|Ketamine drip at a subanesthetic infusion rate (low dose ketamine 5 - 10 mcg/kg/min)
16125451|NCT01969214|Device|IQP-MM-101|"Dissolve the effervescent tablets in half a glass of water, to be taken orally
~1 tablet, 3 times a day"
16125452|NCT01969201|Drug|Urofollitrophin|
16125453|NCT01969201|Drug|Follitrophin alpha|
16125454|NCT01969175|Other|Low-glycemic-load and milk-free diet|
16125455|NCT01969162|Procedure|Tear Sample Collection|Tear sample collection as per protocol. No investigational drug is administered in this study.
16125456|NCT01969149|Drug|Exenatide|
16125457|NCT01969149|Drug|Insulin|
16125458|NCT01969136|Drug|Drug: EVP-6124|
16125459|NCT01969136|Drug|Placebo|
16125460|NCT01969123|Drug|Drug: EVP-6124|
16125461|NCT01969123|Drug|Placebo|
16125462|NCT01969110|Dietary Supplement|Oral IMPACT|Oral IMPACT enriched with arginine, omega-3 fatty acids, and RNA by enteral feeding after surgery
16125463|NCT01969097|Device|tDCS|transcranial direct current stimulation (tDCS)
16125464|NCT01969097|Behavioral|Motor training|Motor training of the affected upper extremity (5 days, 25 min/day).
16125465|NCT01969084|Drug|Linagliptin|
16125466|NCT01969084|Drug|Placebo|
16125467|NCT01969084|Other|Microcirculation testing|The endothelial function of the micro-circulation will be assessed by measuring the hyperemic response of the vessels in the superficial skin of the forearm after the iontophoresis of acetylcholine. The endothelium independent vasodilation will be assessed by the iontophoresis of sodium nitroprusside. Laser Doppler perfusion imaging will be used to measure relative changes in flow velocity.Visible and NIR Medical Hyperspectral Imaging (MHSI) data will be collected with a HyperMed OxyView MHSI System (HyperMed, Inc., Watertown, MA). MHSI images will be obtained from same forearm area where the iontophoresis of acetylcholine and sodium nitroprusside will be performed, before and after the iontophoresis test.
16125468|NCT01969084|Other|Macrocirculation testing|Use ultrasound to measure brachial artery flow mediated vasodilation (FMD, endothelium-dependent vasodilation) and nitroglycerin induced dilation (NID, endothelium-independent vasodilation).
16125469|NCT01969084|Other|MRI Scans|Phosphorus-31 MRI data will be obtained during an exercise protocol. Muscle oxygenation will be measured using the blood oxygenation level-dependent magnetic resonance imaging (BOLD MRI) technique after induced hyperemia.
16125470|NCT01969071|Drug|Levosimendan|The effects of levosimendan on renal function
16125471|NCT01969071|Drug|Dobutamine|Standard Inotropic agent
16125472|NCT01969058|Drug|Isotretinoin|Isotretinoin is a drug that is approved for use in the treatment of severe acne. The aim of this study is to evaluate the role of Isotretinoin on immune activation and inflammation.
16125473|NCT01969045|Device|Enk Fiberoptic Atomizer|Nebulization of local anesthetics with the Enk Fiberoptic Atomizer by Cook Medical during the felxible bronchoscopy
16125474|NCT01969045|Device|bronchoscope|Standard procedure: Administration of local anesthetics via the working channel of the bronchoscope during the felxible bronchoscopy
16125475|NCT01969032|Drug|Paclitaxel, Carboplatinum, Doxorubicin, Endoxan, Capecitabine|Paclitaxel 60 mg/m2 IV weekly plus Carboplatinum AUC2 IV weekly for 9 weeks, then Doxorubicin 25 mg/m2 IV weekly plus Endoxan 50 mg per os q.i.d. plus Capecitabine 500 mg t.i.d for 9 weeks
16125476|NCT01969019|Drug|methylprednisolone, prednisone|
16125477|NCT01969006|Drug|Marcaine ½%|
16125478|NCT01969006|Procedure|Needle prick|
16125479|NCT01968993|Device|nanOss Bioactive - posterolateral gutter|Participants will undergo instrumented PLF at one or two adjacent levels from L2-S1 with PEEK interbody cages (containing allograft or autograft) using nanOss Bioactive in combination with autograft and bone marrow aspirate in the posterolateral gutter on one side. Autograft alone will be used in the opposite posterolateral gutter.
16125480|NCT01968980|Drug|Bococizumab (PF-04950615;RN316)|150 mg every 2 weeks, subcutaneous injection, 12 months
16125481|NCT01968980|Other|Placebo|subcutaneous injection every 2 weeks for 12 months
16125482|NCT01968967|Drug|Bococizumab (PF-04950615; RN316)|150 mg every 2 weeks, subcutaneous injection, 12 months
16125483|NCT01968967|Other|Placebo|subcutaneous injection every 2 weeks for 12 months
16125484|NCT01968954|Drug|Bococizumab (PF-04950615;RN316)|150 mg every 2 weeks, subcutaneous injection, 12 months
16125485|NCT01968954|Other|Placebo|subcutaneous injection, every 2 weeks for 12 months
16125486|NCT01968941|Radiation|Stereotactic Body Radiotherapy (SBRT)|
16125487|NCT01968941|Radiation|Conventional Radiotherapy (CRT)|
16125488|NCT01968915|Drug|LCL161|Patients will receive oral LCL161 once a week until unacceptable toxicity, disease progression and/or withdrawal of consent.
16125489|NCT01968915|Drug|Paclitaxel|Patients will receive weekly paclitaxel as intravenous infusion over 1 hour in combination with LCL161, from cycle 2 in dose escalation part or from the first cycle in dose expansion part, and will continue it until unacceptable toxicity, disease progression and/or withdrawal of consent.
16125490|NCT01968902|Biological|incabotulinumtoxinA|A dose of 200 units to 400 units of Xeomin will be injected by EMG-guided technique into the appropriate muscles in the effected leg at injection visit
16125491|NCT01968902|Biological|Placebo|Saline injection on the day of injection visit
16125492|NCT01968889|Other|Non invasive phrenic nerve stimulation|Non invasive phrenic nerve stimulation allowing to measure the twitch airway pressure during airway occlusion
16125637|NCT01967823|Drug|Aldesleukin|Aldesleukin 720,000 IU/kg intravenously (IV) (based on total body weight) over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).
16125638|NCT01967810|Drug|ANG1005|ANG1005 at a starting dose of 650 mg/m^2 or 600 mg/m^2 by intravenous infusion once every 3 weeks
16125493|NCT01968876|Other|Medication Adherence Smartphone App|MyMedSchedule is a consumer-grade smartphone application currently available on various marketplaces of the Android and iOS platforms that acts as a portal to the free service MyMedSchedule.com website. It can interface with the MedActionPlan discharge planning tool for providers by automatically populating fields, allowing medication lists to be pushed to a subject's MyMedSchedule account, allowing the input of complex medication regimens, and aiding in medication reconciliation. A MyMedSchedule account can be setup with the patient's name, date of birth, allergies, emergency contact, healthcare providers, insurance plan information, and complete medication list. Medication dose and refill reminders can be set and sent through short message service (SMS) text message or e-mail. SMS text message reminders will be used for this study.
16125494|NCT01968850|Drug|alendronate/vitamin D|once weekly 70mg oral dose of alendronate co-formulated with 5600IU vitamin D3 (cholecalciferol) for 24 weeks.
16125495|NCT01968837|Other|Cervical cancer screening|
16125496|NCT01968824|Procedure|Brachial Plexus Nerve Block|The brachial plexus will be visualized under ultrasound and a 22 gauge, 3.5 inch needle will be used. 20 cc of bupivicaine will be injected around the brachial plexus after confirming negative aspiration every 5 cc
16125497|NCT01968811|Device|Avance Foam dressing kit|
16125498|NCT01968798|Drug|Aspirin|100mg enteric-coated aspirin, taken daily
16125499|NCT01968798|Drug|Placebo|100mg enteric-coated placebo, taken daily
16125500|NCT01968785|Radiation|Radiation Dose 25 Gy|Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 25 Gy to the renal artery.
16125501|NCT01968785|Radiation|Radiation Dose 50 Gy|Renal Denervation is performed using the Beta-Cath 3.5F to a deliver radiation dose 50 Gy to the renal artery.
16125502|NCT01968772|Other|Transdermal Magnesium Chloride|Each participant will be provided with a spray bottle containing a transdermal magnesium chloride solution and asked to apply 4 sprays per each arm and each leg 2 times a day as follows: pump 4 sprays into the palm of your hand and apply to each arm and each leg 2 times a day for a total of 32 sprays daily. Rub the contents of 4 sprays on one limb and repeat for each limb coating evenly.
16125503|NCT01968759|Drug|Sevelamer|
16125504|NCT01968759|Drug|Ramipril and Irbesartan|
16125505|NCT01968733|Drug|Solithromycin|
16125506|NCT01968733|Drug|Moxifloxacin|
16125507|NCT01968720|Drug|CAT-2003|
16125508|NCT01968720|Drug|Placebo|
16125509|NCT01968707|Drug|ChloraPrep Hi-Lite Orange|Apply topically.
16125510|NCT01968707|Drug|Normal saline|Apply topically.
16125511|NCT01968707|Drug|3M CHG/IPA Prep Tint 10.5-mL|Apply topically.
16125512|NCT01968707|Drug|3M CHG/IPA Prep Tint 26-mL|Apply topically
16125513|NCT01968694|Drug|IV Lidocaine|
16125514|NCT01968694|Drug|IV diphenhydramine|
16125515|NCT01968681|Procedure|Alexandrite laser|3 different alexandrite laser settings are used in respectively 3 different treatment areas and compared with a non-treated control area.
16125516|NCT01968668|Drug|BAY94-8862|1.25 mg BAY94-8862 tablet once daily in the morning
16125517|NCT01968668|Drug|BAY94-8862|2.5 mg BAY94-8862 tablet once daily in the morning
16125518|NCT01968668|Drug|BAY94-8862|5 mg BAY94-8862 tablet once daily in the morning
16125519|NCT01968668|Drug|BAY94-8862|7.5 mg BAY94-8862 tablet once daily in the morning
16125520|NCT01968668|Drug|BAY94-8862|10 mg BAY94-8862 tablet once daily in the morning
16125521|NCT01968668|Drug|Placebo|Placebo tablet once daily in the morning
16125522|NCT01968668|Drug|BAY 94-8862|15 mg BAY 94-8862 tablet once daily in the morning
16125523|NCT01968668|Drug|BAY 94-8862|20 mg BAY 94-8862 tablet once daily in the morning
16125524|NCT01968655|Biological|OBI-1|OBI-1 is a B domain deleted recombinant porcine factor VIII
16125525|NCT01968642|Behavioral|Educational Intervention|
16125526|NCT01968629|Drug|Eovist|
16125527|NCT01968616|Drug|Ranibizumab, 0.5mg, Intravitreal|
16125528|NCT01968590|Drug|Cholecalciferol|DDrops(trademark) prepared two sets of bottles, one set has 300IU per metered dose and the other set has 2,000IU per metered dose. Participants are randomized to either 600 IU or 4,000 IU, and they take two measured drops orally, once a day. There is a dropper that automatically drops out a measured amount when the bottle is turned upside down.
16125529|NCT01968577|Drug|Rosuvastatin|Rosuvastatin 40 mg before percutaneous coronary intervention
16125530|NCT01968564|Drug|Placebo pill|sugar and other inert substances
16125531|NCT01968564|Drug|High-dose curcumin pill|2000mg curcumin pill/day
16125532|NCT01968564|Drug|Low-dose curcumin pill|500mg curcumin pill/day
16125533|NCT01968551|Drug|E/C/F/TAF|150/150/200/10 mg FDC tablet administered orally once daily
16125534|NCT01968551|Drug|DRV|800 mg tablet administered orally once daily
16125535|NCT01968551|Drug|Baseline DRV- containing ARV regimen|Participants will take their baseline DRV- containing ARV regimen as prescribed.
16125536|NCT01968538|Radiation|Radiation Therapy|
16125537|NCT01968525|Biological|pre-oxygen|3 min of preoxygenation before anesthesia induction.
16125538|NCT01968512|Device|Transcranial Direct Current Stimulation|This technique consists in the use of low voltage electric current to increase or reduce neuronal excitability in the area stimulated. This is a non-invasive and safe intervention having infrequent and insignificant side effects characterized by mild local discomfort, itching, tingling and/or headache of short term.
16125539|NCT01968512|Device|Sham|Same character of Transcranial Direct Current Stimulation but without current
16125540|NCT01968486|Drug|PDT standard fluence, ranibizumab|In the verteporfin PDT combination therapy arm patients were treated on day one with 0.5 mg (10 mg/ml) IVR injection and after seven days with PDT standard fluence (wavelength, 689 nm; dose, 50 J/cm2; light intensity, 600 mW/cm2 for 83 s). Ranibizumab pro re nata (PRN) could be administered with a 30-day interval if re-treatment criterion were met. Re-treatment was based on increase of intraretinal or subretinal fluid > 50 μm on OCT; loss of 5 letters or more on BCVA Early Treatment Diabetic Retinopathy Study (ETDRS) chart; fluorescein leakage from the CNV on FA images.
16125639|NCT01967810|Drug|Bevacizumab|For participants enrolled in the bevacizumab-refractory recurrent GBM arm (Arm 2), treatments with bevacizumab may be continued and administered every 2 or 3 weeks at the Investigator's discretion.
16125684|NCT01967459|Drug|Cholecalciferol|Single dose D-cura cholecalciferol drink 250 000 IU/ml, in total 75 000 IU (=3ml)
16125541|NCT01968486|Drug|PDT reduced fluence, ranibizumab|In the verteporfin PDT combination therapy arm patients were treated on day one with 0.5 mg (10 mg/ml) IVR injection and after seven days with PDT reduced fluence ( wavelength, 689 nm; dose, 25 J/cm2 ; light intensity, 300 mW/cm2 for 83 s).Ranibizumab pro re nata (PRN) could be administered with a 30-day interval if re-treatment criterion were met. Re-treatment was based on increase of intraretinal or subretinal fluid > 50 μm on OCT; loss of 5 letters or more on BCVA Early Treatment Diabetic Retinopathy Study (ETDRS) chart; fluorescein leakage from the CNV on FA images.
16125542|NCT01968486|Drug|ranibizumab|In the ranibizumab monotherapy arm patients were treated with a loading phase of three consecutive 0.5 mg (10 mg/ml) IVR injections every six weeks. Ranibizumab pro re nata (PRN) could be administered with a 30-day interval if re-treatment criterion were met. Re-treatment was based on increase of intraretinal or subretinal fluid > 50 μm on OCT; loss of 5 letters or more on BCVA Early Treatment Diabetic Retinopathy Study (ETDRS) chart; fluorescein leakage from the CNV on FA images.
16125543|NCT01968473|Device|NMES Device comfort|NMES device, establishing Sensory, Motor and Pain thresholds and Pain tolerance.
16125544|NCT01968460|Drug|P2B001 once daily (pramipexole 0.6 mg / rasagiline 0.75 mg),|Fixed Dose Combination of pramipexole 0.6 mg and rasagiline 0.75 mg once daily
16125545|NCT01968460|Drug|Placebo|placebo
16125546|NCT01968460|Drug|P2B001 once daily (pramipexole 0.3 mg / rasagiline 0.75 mg),|Fixed Dose Combination of pramipexole 0.3 mg and rasagiline 0.75 mg once daily
16125547|NCT01968447|Other|hypocapnia|Hyperventilation to the level of hypocapnia
16125548|NCT01968447|Other|normocapnia|Normal ventilation to the level of nromocapnia
16125549|NCT01968434|Device|protective cough syrup|The mucoadhesive and radical scavenging properties of the components create a protective film on the pharynx which protects irritated mucosa from cough generating stimuli such as post nasal drip, irritating elements, dehydration.
16125550|NCT01968434|Drug|carbocisteine cough syrup|Mucolytic
16125551|NCT01968421|Drug|OM-85 BV|two courses of 7mg of OM-85 or matching placebo to take one oral capsule per day for 10 days a month for 3 consecutive months at the beginning of the study, then 3 months later with the same schedule for 1 year.
16125552|NCT01968408|Dietary Supplement|Lactobacillus reuteri DSM 17938|10(9) CFU/daily
16125553|NCT01968408|Dietary Supplement|Placebo|
16125554|NCT01968395|Drug|Caspofungin 70 mg|Intravenous use
16125555|NCT01968382|Drug|IMM 124-E (Hyperimmune Bovine Colostrum)|Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.
16125556|NCT01968382|Drug|Placebo (High protein milk powder)|Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily
16125557|NCT01968369|Dietary Supplement|tomato sauce|We are randomising healthy men (N=14-28) to consume a high fat meal either with or without tomato sauce (80 gr) in a cross-over design with a 7 days wash-out period. During the week before the study, all the subjects will be maintained in a low fibers diet and only subjects randomized to tomatoes will receive a daily dose of 80 mg of tomato sauce (80 gr for 7 days= total load 560 mg).
16125558|NCT01968356|Drug|3M CHG/IPA Prep Colorless|Apply topically.
16125559|NCT01968356|Drug|3M CHG/IPA Prep Tint|Apply topically.
16125560|NCT01968356|Drug|ChloraPrep|Apply topically.
16125561|NCT01968356|Drug|Saline|Apply topically.
16125562|NCT01968343|Behavioral|Cognitive-behavioral therapy.|Subjects receive 22 sessions of cognitive-behavioral therapy.
16125563|NCT01968343|Other|Supportive therapy.|Subjects receive 22 sessions of supportive therapy.
16125564|NCT01968330|Behavioral|Go!®to sleep|
16125565|NCT01968317|Drug|Megestrol acetate and metformin|Patients will receive metformin 500 mg by mouth third daily and megestrol acetate 160 mg by mouth daily for 3 months.
16125566|NCT01968317|Drug|Megestrol acetate|Patients will receive megestrol acetate 160 mg by mouth daily for 3 months.
16125567|NCT01968304|Other|Iron status follow up|
16125568|NCT01968291|Behavioral|Teach-back|Patients are asked to repeat back in their own words their understanding of the discharge information that was provided to them.
16125569|NCT01968278|Other|Baked milk|
16125570|NCT01968265|Drug|ISIS-GCCRRx|3 doses on alternate days during the first week and then once weekly for 5 weeks + daily metformin
16125571|NCT01968265|Drug|Placebo|3 doses on alternate days during the first week and then once weekly for 5 weeks + daily metformin
16125572|NCT01968252|Other|Concurrent TTE and TEE|All subjects will undergo both transthoracic echocardiography and transesophageal echocardiography to compare the results of measurements obtained from both imaging locations.
16125573|NCT01968239|Drug|Ranibizumab|comparison of different re-treatment criteria for intravitreal injection of ranibizumab
16125574|NCT01968226|Drug|[F-18] RDG-K5|Up to fifteen (15) subjects with carotid stenosis >50% who are undergoing planned carotid endarterectomy will be imaged under PET with [F-18] RDG-K5
16125575|NCT01968213|Drug|Rucaparib|Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole.
16125576|NCT01968213|Drug|Placebo|Oral tablets administered twice daily with 8 oz (240 mL) of water on an empty stomach or with food; 28-day cycles of treatment. Doses should be taken as close to 12 hours apart as possible, preferably at the same times every day. Tablets should be swallowed whole.
16125577|NCT01968200|Drug|Enalapril|Naprilene 5 mg tablets; Dosage: 2.5 to 10 mg/12h Duration of treatment: up to end of follow up
16125578|NCT01968187|Drug|FE 992097|
16125579|NCT01968187|Drug|Placebo|
16125580|NCT01968161|Drug|Asenapine|
16125581|NCT01968135|Drug|Combined Oral Contraceptive Pill|150 mcg levonorgestrel and 30 mcg ethinyl estradiol combined oral contraceptive pill
16125582|NCT01968135|Drug|Placebo Sugar Pill|Placebo Sugar Pill
16125678|NCT01967498|Drug|Montelukast|
16125679|NCT01967485|Other|Text- Messaging|Text messages will be sent to the parents of children enrolled in the study.
16125680|NCT01967485|Other|Treatment as usual|Children will receive stimulant treatment for ADHD.
16125681|NCT01967472|Drug|amodiaquine-artesunate (AQAS) fixed-dose|
16125682|NCT01967472|Drug|Artemether-lumefantrine combination (AL) dispersable|
16125685|NCT01967433|Drug|Diphenhydramine|
16125686|NCT01967433|Drug|Placebo|
16125583|NCT01968122|Device|intravascular stent therapy|Device selection depended on arterial access and lesion morphology. For patients with smooth arterial access and Mori A lesion or the mid-basilar artery and distal M1 segment lesions, the Apollo balloon-mounted stent was selected. For patients with tortuous arterial access and Mori B or C lesion, or lesion with a significant mismatch in the diameter between proximal and distal segment, angioplasty plus self-expanding stent (Gateway balloon plus Wingspan stent system) is preferred . For patients with tortuous arterial access with a Mori A lesion, or small target vessel diameter (<2.5 mm), direct dilation with Gateway balloon was selected. If severe dissection or elastic recoil occurred after angioplasty, a balloon-mounted stent (for patients with less tortuous access) or Wingspan (for patients with severe tortuous access or small target vessel) stent were allowed to be implanted.
16125584|NCT01968109|Biological|Relatlimab|
16125585|NCT01968109|Biological|Nivolumab|
16125586|NCT01968109|Biological|BMS-986213|Relatlimab + Nivolumab
16125587|NCT01968096|Device|home-based ankle continuous passive motion machine.|A rehabilitation program of machine driven passive stretch.
16125588|NCT01968083|Biological|RSV cps2 Vaccine|10^5.3 plaque forming units (PFUs) or RSV cps2 vaccine will be administered as nose drops (0.25 mL per nostril, for a total of 0.5 mL).
16125589|NCT01968083|Biological|Placebo Vaccine|Placebo vaccine will be administered as nose drops (0.25 mL per nostril, for a total of 0.5 mL).
16125590|NCT01968070|Drug|LY3127760|Administered orally
16125591|NCT01968070|Drug|Celecoxib|Administered orally
16125592|NCT01968070|Drug|Placebo|Administered orally
16125593|NCT01968057|Drug|Baricitinib|Administered orally
16125594|NCT01968057|Drug|Ciclosporin|Administered orally
16125595|NCT01968044|Drug|Gemigliptin|
16125596|NCT01968044|Drug|Placebo to Linagliptin|
16125597|NCT01968031|Drug|Istradefylline 40 mg|Istradefylline 40 mg and placebo
16125598|NCT01968031|Drug|Istradefylline 20 mg|Istradefylline 20 mg and placebo
16125599|NCT01968031|Drug|Placebo|Placebo
16125600|NCT01968018|Drug|Tramadol HCI/acetaminophen|Participants will receive tablet of tramadol HCI (37.5 mg)/acetaminophen (325 mg) on Day 1. Participants may increase their daily dosage of study medication is 1 to 2 tablets every 4 to 6 hours as needed for pain relief up to maximum of 8 tablets per day.
16125601|NCT01968005|Drug|Etoreat®(Etodolac-Lidocaine Topical Patch)|
16125602|NCT01968005|Drug|Placebo|
16125603|NCT01967992|Behavioral|Behavioral: Low Carbohydrate, Ketogenic Diet|
16125604|NCT01967992|Behavioral|American Diabetes Association Diet|
16125605|NCT01967992|Behavioral|Mindfulness and Positive Affect Skills|
16125606|NCT01967979|Drug|RO5285119|Single dose, alone and after repeated administration of itraconazole or fluoxetine
16125607|NCT01967979|Drug|fluoxetine|Multiple doses
16125608|NCT01967979|Drug|itraconazole|Multiple doses
16125609|NCT01967966|Drug|GDC-0032|Single oral dose
16125610|NCT01967966|Drug|GDC-0032|Single IV dose
16125611|NCT01967953|Procedure|EVLP Group|"EVLP technique: Steen solution; normothermia; low flow, open atrium, low hematocrit.
~Endpoints of EVLP assessment of lungs suitability: oxygenation, respiratory mechanics, pulmonary vascular resistance, chest X-ray, fibrobronchoscopy"
16125612|NCT01967940|Drug|TAF|25 mg tablet administered orally once daily with food
16125613|NCT01967940|Drug|Placebo|Tablets to match TAF administered orally once daily with food
16125614|NCT01967940|Drug|E/C/F/TAF|150/150/200/10 mg STR administered orally once daily with food
16125615|NCT01967940|Drug|Current failing ARV regimen|Participants will continue taking their current ARV regimen as prescribed in Part 1.
16125616|NCT01967940|Drug|ATV|300 mg tablet administered orally once daily.
16125617|NCT01967927|Drug|18F-MISO|A radiolabeled imaging agent that has been used for investigating tumor hypoxia with positron emission tomography (PET).
16125618|NCT01967914|Other|PVI|Measurement of PVI (plethysmography variability index)
16125619|NCT01967901|Behavioral|Self-care management program|The self-care management consists of the usual care with an additional multidisciplinary self-management program that includes additional home and clinic visits and telephone follow-ups made by the self-care management nurse and clinic visits to the dietician.
16125622|NCT01967875|Drug|Capecitabine+Cisplatin|Cisplatin 75mg/m2, d1; Capecitabine 1700-2000mg/m2/day on days1-14 every 21 days, 6 cycles.Capecitabine is to be continued until disease progression or intolerable toxicity.
16125623|NCT01967875|Drug|Docetaxel+Capecitabine|Docetaxel 75mg/m2, d1; Capecitabine 1700-2000mg/m2/day on days1-14 every 21 days, 6 cycles. Capecitabine is to be continued until disease progression or intolerable toxicity.
16125624|NCT01967862|Procedure|computed tomography|Undergo CT
16125625|NCT01967862|Procedure|bone scan|Undergo bone scan
16125626|NCT01967862|Procedure|3-Tesla magnetic resonance imaging|Undergo axial MRI
16125627|NCT01967862|Procedure|diffusion-weighted magnetic resonance imaging|Undergo WB MRI
16125628|NCT01967862|Radiation|fluorine F 18 sodium fluoride|Undergo fluorine F 18 sodium fluoride PET/CT
16125629|NCT01967862|Procedure|computed tomography|Undergo fluorine F 18 sodium fluoride PET/CT
16125630|NCT01967862|Procedure|positron emission tomography|Undergo fluorine F 18 sodium fluoride PET/CT
16125631|NCT01967862|Other|laboratory biomarker analysis|Correlative studies
16125632|NCT01967849|Diagnostic Test|Oral Glucose tolerance test|
16125633|NCT01967836|Device|Glad Press 'n Seal|Application of Glad Press n' Seal product as an IV site dressing protection during subject showering
16125634|NCT01967823|Biological|Anti-NY ESO-1 mTCR PBL|Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20-30 minutes.
16125635|NCT01967823|Drug|Cyclophosphamide|Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenously (IV) in 250 mL dextrose 5% in water (D5W) infused simultaneously with mesna 15 mg/kg/day over 1 hour x 2 days.
16125636|NCT01967823|Drug|Fludarabine|Days -7 to -3: Fludarabine 25 mg /m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
16125683|NCT01967459|Drug|Cholecalciferol|Single dose D-cura cholecalciferol drink 100 000 IU/ml, in total 300 000 IU (=3ml)
16125640|NCT01967797|Behavioral|5As Team Intervention|The intervention group will participate in an additional 6 month intensive learning collaborative model designed around the 5As of obesity management, but which addresses areas identified as barriers (i.e. weight bias, clinical environment, clinic processes & team based care, mental health, counseling around emotional eating, caregiver fatigue, designing appropriate patient follow-up, and additional topics identified by the professionals). A clinical Champion identified by our partner SSPCN will be available to provide 1:1 support and coaching of the practitioners & teams as needed. The practitioners will work collaboratively to do their own needs assessment, and will identify additional resources or tools that they need to overcome the barriers to weight management in their setting. The research team will use a Practice Facilitation model to provide additional resource and support to the change process for the practitioners.
16125641|NCT01967784|Biological|Quadrivalent Influenza Vaccine (split virion, inactivated)|0.5 mL, Intramuscular
16125642|NCT01967771|Drug|DTG|DTG will be supplied as 50 mg tablet to be administered orally
16125643|NCT01967771|Drug|CBZ|CBZ will be supplied as 100 mg and 200 mg extended release tablet to be administered orally
16125644|NCT01967758|Biological|Cohort 1|Four doses of IV ADU-623 at a dose of 3 x 10^7cfu
16125645|NCT01967758|Biological|Cohort 2|Four doses of IV ADU-623 at a dose of 3 x 10^8cfu
16125646|NCT01967758|Biological|Cohort 3|Four doses of IV ADU-623 at a dose of 3 x 10^9cfu
16125647|NCT01967758|Drug|Antibiotics|A 3-day course of oral amoxicillin (500 mg three times per day) or trimethoprim/sulfamethoxazole in penicillin-allergic patients (160 mg trimethoprim / 800mg sulfamethoxazole at 12 hour intervals) will be initiated for each patient 3 days following each dose of ADU-623. Patients will receive a 7-day course of antibiotics starting at the end of treatment visit.
16125648|NCT01967745|Procedure|laparoscopic appendectomy|The laparoscopic appendectomy was performed with three trocars. Pneumoperitoneum was created using an open Hasson technique. The mesoappendix was divided using a harmonic scalpel or endoscopic tissue fusion device. The appendix was divided by placing one endoscopic loop and cut with harmonic scalpel. The specimen was removed through the umbilical port.
16125649|NCT01967745|Procedure|open appendectomy|The open appendectomy was carried out in the standard way with McBurney muscle splitting incision (in supine position).
16125650|NCT01967732|Other|THS 2.2|Single use of the Tobacco Heating System 2.2 (THS 2.2)
16125651|NCT01967732|Other|CC|Single use of subject's own conventional cigarette (CC)
16125652|NCT01967732|Other|NNS|Single administration of 1 mg of nicotine
16125653|NCT01967719|Other|mTHS 2.2|Single use of mTHS 2.2
16125654|NCT01967719|Other|mCC|Single use of subject's own mCC
16125655|NCT01967719|Other|NNS|Single administration of 1 mg of nicotine
16125656|NCT01967706|Other|mTHS|Single use of Tobacco Heating System 2.2 Menthol (mTHS)
16125657|NCT01967706|Other|mCC|Single use of subject's own menthol cigarette (mCC)
16125658|NCT01967706|Other|NRT|Single administration of 2 mg gum (Nicorette® 2mg)
16125659|NCT01967693|Procedure|Retrospective analysis of data|Retrospective data analysis
16125660|NCT01967680|Procedure|Non-sedation for intubated, mechanically ventilated patients|
16125661|NCT01967680|Procedure|Controlgroup, sedation with daily wake-up trial|
16125662|NCT01967667|Dietary Supplement|Liposomal glutathione|Escalating dose steps
16125663|NCT01967667|Dietary Supplement|Placebo|escalating dose steps
16125664|NCT01967654|Other|Technical Assistance, training and clinical reminders|
16125665|NCT01967654|Other|Referral to Community Health Worker|
16125666|NCT01967641|Drug|buprenorphine/naloxone combination|Buprenorphine/naloxone (Bup/Nx; Suboxone sublingual tablets, Reckitt Benckiser) will be administered sublingually at daily doses of 2/0.5, 8/2 mg, and 16/4 mg, which are within the recommended dose range for treating both pain and opioid abuse. The total daily dose will be divided and administered on a QID dosing regimen (0.5/0.125, 2/0.5, and 4/1 mg QID at 0830, 1230, 1730, 2130). Each participant will be tested with all three doses in random order for two weeks at each dose (one week of stabilization followed by one week of testing). Following completion of the 7-week inpatient phase, participants will be maintained on 16/4 mg Bup/Nx.
16125667|NCT01967628|Dietary Supplement|Vitamin D3 (cholecalciferol)|
16125668|NCT01967628|Dietary Supplement|Placebo Sugar Pill|
16125669|NCT01967589|Drug|NNC0113-0987|Once-daily doses for oral administration. Multiple doses with sequential dose increments over 10 weeks. Progression to next dose increment is based on a safety evaluation
16125670|NCT01967589|Drug|placebo|Once-daily doses for oral administration
16125671|NCT01967576|Drug|Axitinib (AG-013736)|5 mg twice a day on a 28-day cycle.
16125672|NCT01967550|Drug|diclofenac diethylamine, DDEA 2.32% gel|
16125673|NCT01967550|Drug|Placebo|
16125674|NCT01967537|Drug|68Gallium DOTATATE|Fasting is not required prior to the imaging study. An IV line with a large bore (21 gauge or more) will be placed preferably in the antecubital vein, and, with the patient supine, around 5mCi of the 68Ga-DOTATATE will be administered intravenously, followed by incubation for approximately 60 minutes. Then the patient will be positioned in a PET/CT scanner and images from the upper thighs to the base of the skull will be obtained. In patients with tumor induced osteomalacia, images from the top of the head to the toes will be obtained.
16125675|NCT01967537|Procedure|Radio-guided surgery|Using 68Gallium DOTATATE
16125676|NCT01967524|Drug|botulinum toxin A + ropivacaïne|"D0 :
~Calcul of the average of EN (digital scale) (EN completed from D-8 to D-1)
~QDSA (Saint-Antoine pain questionnaire)
~QCD (Pain questionnaire)
~MPI (Multidimensional Pain Inventory)
~Beck scale
~HAD (Hospital Anxiety and Depression scale)
~SF36 (Short Form 36)
~injection of botulinum toxin A associated with ropivacaïne
~D30, D90, D120 and D150 (phone call): Calcul of the average of EN
~D60 and D180 (on site visits): adverse events reporting, calcul of the average of EN, PGI-I (Patient Global Impression of Improvement), questionnaires (QDSA, QCD, MPI, treatment satisfaction, Beck scale, HAD and SF36)."
16125677|NCT01967524|Drug|Ropivacaïne|"D0 :
~Calcul of the average of EN (digital scale) (EN completed from D-8 to D-1)
~QDSA (Saint-Antoine pain questionnaire)
~QCD (Pain Questionnaire)
~MPI (Multidimensional Pain Inventory)
~Beck scale
~HAD (Hospital Anxiety and Depression scale)
~SF36 (Short Form 36)
~injection of ropivacaïne alone
~D30, D90, D120 and D150 (phone call): Calcul of the average of EN
~D60 and D180 (on site visits): adverse events reporting, calcul of the average of EN, PGI-I (Patient Global Impression of Improvement), questionnaires (QDSA, QCD, MPI, treatment satisfaction, Beck scale, HAD and SF36)."
16125687|NCT01967420|Behavioral|Cognitive remediation|CIRCuiTS is a computerised cognitive remediation program which consists of tasks to improve cognition, the use of strategy training and the teaching of generalisable community functioning skills.
16125688|NCT01967420|Behavioral|Social cognition training|The social cognition training is a computerised program which aims to improve emotion recognition through a variety of lessons and games.
16125689|NCT01967407|Procedure|Irreversible Electroporation (IRE)|Percutaneous CT-fluoroscopic-guided Irreversible Electroporation.
16125690|NCT01967394|Other|Use of internet based social marketing intervention|"Eleven counties in Kentucky will be targeted with ads on Google and Facebook that direct adolescent mothers to an Internet-based social marketing intervention. The ads will be implemented using Facebook's and Google's ad network. The ads are setup, configured, and adjusted online. Facebook has identified key words that are recommended for adolescent mothers: 16 and pregnant, teen mom,' and names of television shows with subject matter specific to adolescent mothers. We will target the ads to correspond to a geographical area that specifies a distance from the largest city in each county, and we will specify county lines. Ads will only appear on the Internet in the counties that are targeted for the intervention."
16125691|NCT01967394|Other|No use of social media|No social media ads will be available in these counties.
16125692|NCT01967381|Drug|Methamphetamine (Desoxyn®)|The pharmacodynamic effects of methamphetamine (Desoxyn®) will be determined during placebo, oxazepam (Serax®), naltrexone (Revia®) and combined oxazepam and naltrexone maintenance.
16125693|NCT01967368|Drug|Intanza|Principal Investigator would be responsible for injecting the intradermal vaccine in a sterile technique.
16125694|NCT01967368|Drug|Vaxigrip|Principal Investigator would be responsible for injecting the intrmuscular vaccine in a sterile technique.
16125695|NCT01967355|Other|lipid apheresis|
16125696|NCT01967342|Behavioral|Pain Ed|A 10-week psychosocial group treatment for chronic pain that focuses on providing information about the development, course, and treatment of chronic pain, as well as information about factors associated with reduced pain (e.g., sleep). In particular, it seeks to empower patients to take ownership of their chronic pain care through building deeper knowledge about their pain condition and their interactions with the health care system.
16125697|NCT01967342|Behavioral|CBT for Pain|A 10-week psychosocial group treatment for chronic pain that focuses on providing information and skills about the development, course, and treatment of chronic pain, as well as information about factors associated with reduced pain (e.g., sleep). In particular, it seeks to empower patients to self-manage their chronic pain through building deeper knowledge about and better skills for improving their pain condition and their interactions with the health care system.
16125698|NCT01967342|Other|Usual Care|A comparison condition in which patients receive standard individualized medical care from the federally qualified health center partnering on this study. Care can include basic biological interventions, such as medication or surgery, as well as supplementary care such as chiropractic or physical therapy. However, cost has a pragmatic influence on the amount of services provided, sought, and received.
16125699|NCT01967329|Drug|Standard Triple|Oral twice-daily doses of rabeprazole (20 mg), amoxicillin (1 g) and clarithromycin (500 mg)
16125700|NCT01967329|Drug|Sequential|Oral twice-daily doses of rabeprazole (20 mg) and amoxicillin (1 g) on days 1-5, and on days 6-10, rabeprazole (20 mg), metronidazole (500 mg) and clarithromycin (500 mg)
16125701|NCT01967329|Drug|Quadruple|Oral doses of rabeprazole (20 mg) twice daily, metronidazole (500 mg) three times daily, bismuth subsalicylate (Pepto-Bismol) (2 tablets) four times daily and tetracycline (500 mg) four times daily
16125702|NCT01967290|Device|Vibratory feedback and 3D movement analysis|Hand-to-mouth task performed under vibratory feedback combined with 3D continuous movement analysis.
16125703|NCT01967290|Device|Only 3D movement analysis|Hand-to-mouth task performed under 3D continuous movement analysis only
16125704|NCT01967277|Device|Handi-Dome Laser|One, 30 minute treatment, every other day for 16 weeks.
16125705|NCT01967277|Device|Incandescent red light source.|One, 30 minute treatment, every other day for 16 weeks.
16125706|NCT01967264|Drug|Udenafil|Udenafil tablets
16125707|NCT01967264|Drug|Placebo|Placebo tablets
16125708|NCT01967251|Drug|Udenafil|Udenafil tablets
16125709|NCT01967251|Drug|Placebo|Udenafil placebo-matching tablets
16125710|NCT01967238|Biological|IM Pneumococcal, meningococcal, or flu vaccine|Volunteers given one of the 3 vaccines
16125711|NCT01967225|Drug|Tedizolid Phosphate (Sivextro, BAY1192631)|BAY1192631 solution or tablet 200 mg, once daily, Intravenous (IV) or By Mouth (PO) for 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia.
16125712|NCT01967225|Drug|Linezolid|Linezolid solution or tablet 600 mg, twice daily, every 12 ±3 hours, Intravenous (IV) or By mouth (PO) 7-14 days for skin and soft tissue infections (SSTI) or 7-21 days for bacteremia.
16125713|NCT01967212|Device|Game-based swallow biofeedback|"The intervention are divided into two parts：
~Traditional swallowing training 30 min by speech therapist.
~Game-based biofeedback combined with Mendelsohn's maneuver and effortful swallow 30 min by investigator."
16125714|NCT01967212|Behavioral|Swallow training without biofeedback|"The intervention are divided into two parts：
~Traditional swallowing training 30 min by speech therapist.
~Mendelsohn's maneuver and effortful swallow without biofeedback 30 min."
16125715|NCT01967199|Device|Everolimus-eluting balloon expandable stent|Everolimus-eluting balloon expandable stent (Xience Prime or Xience Xpedition or Xience Alpine)
16125716|NCT01967199|Device|paclitaxel eluting balloon|paclitaxel eluting balloon (SeQuent Please)
16125717|NCT01967186|Procedure|Intraportal islet transplantation|
16125718|NCT01967186|Procedure|Intramuscular islet transplantation|
16125719|NCT01967186|Procedure|Intramuscular transpl with stemcells|
16125720|NCT01967186|Procedure|Kidney transplantation|All patients will undergo kidney transplantation regardless of arm
16125721|NCT01967173|Drug|Flovent Diskus® 100 mcg|Flovent is an ICS
16125722|NCT01967173|Drug|Flovent Diskus® 250 mcg|Flovent is an ICS
16125723|NCT01967173|Drug|Flovent Diskus® 500 mcg|Flovent is an ICS
16125724|NCT01967173|Drug|Advair Diskus® 100/50 mcg|Advair is an ICS/LABA combination
16125725|NCT01967173|Drug|Advair Diskus® 250/50 mcg|Advair is an ICS/LABA combination
16125726|NCT01967147|Drug|Propylene Glycol, 0.6% eye drops|Commercially available eye drops used during Treatment Phase
16125828|NCT01966406|Device|Nasogastric tube|
16125727|NCT01967147|Drug|Preservative-free 0.9% Saline solution|Commercially available solution used as Run-in (1 drop in each eye 4 times a day for 15 days) and during Treatment Phase
16125728|NCT01967134|Biological|H56:IC31|H56:IC31 contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c) formulated in the Th1-stimulating IC31 adjuvant.
16125729|NCT01967121|Device|Compex unit's Active Recovery® program|Compex unit's Active Recovery® program will be performed for 15 minutes once per day.
16125730|NCT01967121|Other|Ice application|Participants will apply ice on their hamstring for 15 minutes three times per day until muscle soreness is no longer present
16125731|NCT01967108|Other|chest physiotherapy|chest physiotherapy, up to one hour from extubation, in ICU patients
16125732|NCT01967095|Drug|erlotinib|Cycle 1, week 1 (D1-D7) will consist of pulse dose erlotinib on D1 & D2 without daily low dose erlotinib on D3-7. For all subsequent weeks, patients will take high dose erlotinib on D1 & D2, & will receive erlotinib 50 mg oral daily x 5 days on days 3-7. On days 1 & 2, patients will take one of the following doses of erlotinib, depending on the dose cohort they are enrolled in: Dose level 1 600 mg oral daily on D1, D2 Dose level 2 750 mg oral daily on D1, D2 Dose level 3 900 mg oral daily on D1, D2 Dose level 4 1050 mg oral daily on D1, D2. An additional Dose -1 (pulse dose erlotinib on D1, D2 with 25 mg oral daily x 5 days in D3-D7) will be reserved, in the unlikely situation that Dose 1 is proved too toxic. If Dose -1 is tolerated well (600mg oral daily D1, D2 & 25mg oral daily D3-D7), pulse dose escalation can continue as described above, with erlotinib at the daily low dose of 25 mg oral on D3-D7.
16125733|NCT01967082|Behavioral|APPSPIRE|Given APPSPIRE app
16125734|NCT01967082|Behavioral|Focus Group|Attend focus group
16125735|NCT01967082|Other|Survey Administration|Complete survey
16125736|NCT01967069|Drug|DFD01 Spray|
16125737|NCT01967069|Drug|Vehicle Spray|
16125738|NCT01967043|Drug|Oraxol|Oraxol (Paclitaxel + HM30181AK). Paclitaxel will be supplied as 30 mg capsules and HM30181AK-US will be supplied as 15 mg tablets.
16125739|NCT01967017|Drug|Lidocaine|
16125740|NCT01967017|Drug|Placebo|
16125741|NCT01967004|Device|Morph|Morph is a small electric controller that is retrofit into existing myoelectric prostheses to equip them with wireless identification capabilities. Specifically, Morph allows the prosthesis to react to RFID tags in the environment.
16125742|NCT01966978|Drug|Metformin|Metformin will be started at 500 mg daily (or continued at current dose)and weekly titrated to 2000 mg or maximum tolerated dose (at least 1000 mg/day)
16125743|NCT01966978|Drug|Detemir|Insulin detemir will be started in both groups at 0.3 units/kg or conversion 1:1 from dose of basal insulin prior to randomization. The titration will be primarily patient-driven, based on our study protocol table. Additional physician driven titration will be allowed in both groups if patient fails to intensify basal insulin dose as directed.
16125744|NCT01966978|Drug|Liraglutide|Initial dose of 0.6 mg/day with weekly increments of 0.6 mg until dose of 1.8 mg/day or maximal tolerated dose (at least 1.2 mg/day)is reached
16125745|NCT01966978|Drug|Insulin Aspart|Insulin aspart will be initiated at a dose of 0.3 units/kg/day divided among the number of meals taken daily and titrated based on physician clinical judgment with the goal of pre-prandial BG 70-130 mg/dL and post-prandial BG <180
16125746|NCT01966965|Drug|PIOLIN®|PIOLIN® SHAMPOO 5 DAYS CONTINUOUSLY STOP A WEEK AND APPLY AGAIN
16125747|NCT01966965|Drug|NEDAX|AS SPECIFIED AT THE LEAFLET
16125748|NCT01966926|Behavioral|weighing frequency instructions and tips|Weekly emails with nutrition, physical activity, and weight tracking tips sent for 24 weeks
16125749|NCT01966913|Drug|Bevacizumab|
16125750|NCT01966913|Drug|ICE chemotherapy regimen|Etoposide, 300 mg/m²/d in two daily injections at 12-h intervals, Carboplatin, AUC 4/d by injections adjusted daily to the creatinine clearance, Ifosfamide, 2400 mg/m²/d, For 5 consecutive days followed by HSC reinjection and G-CSF (filgrastim- Neupogen) on D11 of each intensive cycle
16125751|NCT01966900|Biological|CN54gp140 mixed with GLA-AF|Each vaccination an intramuscular injection of 100 micrograms CN54gp140 mixed with 5 micrograms GLA-AF
16125752|NCT01966887|Genetic|MYDICAR-single intracoronary infusion|AAV1/Serca2a
16125753|NCT01966887|Genetic|Placebo; single intracoronary infusion|single intracoronary infusion
16125754|NCT01966861|Other|weaning guided by LUS (lung ultrasound)|Predictive early signs of respiratory distress are assessed by lung ultrasound (LUS score >14) and if present will trigger protocolised intervention (eg- fluid balance,diuretics, thoracocentesis, antibiotics when required [CPIS>6], hemglobin>8g/dl triggers transfusion)
16125755|NCT01966848|Device|Wich prosthesis is used|
16125756|NCT01966835|Behavioral|High intensity aerobic interval training|The intervention consists of a total of 18 moderate-to-high intensity aerobic interval training sessions (20-30 minutes/session) spread over a maximum of eight weeks (2-3 times/week) as shown in Table 1. The training sessions are performed on bicycle ergometers (Kettler) and supervised by physiotherapists. Each session is built up by brief periods of high-intensity aerobic exercise (70-80 %) separated by recovery periods of lower-intensity (40-50%). Each session is introduced by a 5-minute warm-up and ends with a 5-minute cool-down (equivalent to 40-50% watt max). The absolute exercise intensity/workload (watt) is determined individually for each participant based on the watt max test performed at baseline.
16125757|NCT01966822|Drug|Dolutegravir, 50mg every 24 hours|Dolutegravir, 50mg every 24 hours
16125758|NCT01966822|Drug|Protease Inhibitor/ritonavir|Protease Inhibitor/ritonavir
16125759|NCT01966809|Drug|Photofrin photodynamic therapy.|"The subjects will receive a dose of 2.5 mg/kg of Photofrin intravenously 24 hours before planned surgical resection. Tumor resection will be carried out in the standard fashion in order to achieve the maximum tumor resection compatible with preservation of neurological function. After resection, Intralipid will be infused into the craniotomy and kept for approximately 45 min, while PDT will be performed. The illumination time will be calculated from the power density (mW) emitted by the laser and the radius (r) of the cavity to deliver a total light dose of 240 J/cm2 at a using the following formula:
~Treatment Time (sec) = Light dose (J/cm2) x Cavity surface (cm2) x 1000 Power density (mW) Cavity Surface (cm2) = 4 x 3.14 x r2 The optical fiber will be placed in the center of the surgical cavity and photoillumination will commence. After PDT, the Intralipid solution will be removed and the wound will be closed. The subject will be sent to the intensive care area for recovery."
16125760|NCT01966783|Drug|Budesonide 2 mg suppository|per day
16125761|NCT01966783|Drug|Budesonide 4 mg suppository|per day
16125762|NCT01966783|Drug|Mesalazine 1 g suppository|per day
16125763|NCT01966783|Drug|Budesonide 2 mg suppository/Mesalazine 1 g suppository|per day
16125764|NCT01966770|Device|Pair 1 (ocufilcon D / ocufilcon D)|Randomized to contra lateral lens pair 1 (ocufilcon D hydrogel / ocufilcon D hydrogel)
16125765|NCT01966770|Device|Pair 2 (ocufilcon D / enfilcon A)|Randomized to contra lateral lens pair 2 (ocufilcon D hydrogel / enfilcon A silicone)
16125766|NCT01966770|Device|Pair 3 (ocufilcon D / comfilcon A)|Randomized to contra lateral lens pair 3 (ocufilcon D hydrogel / comfilcon A silicone)
16125767|NCT01966770|Device|Pair 4 (methafilcon A / methafilcon A)|Randomized to contra lateral lens pair 4 (methafilcon A hydrogel sphere / methafilcon A hydrogel asphere)
16125768|NCT01966770|Device|Pair 5 (methafilcon A / comfilcon A)|Randomized to contra lateral lens pair 5 (methafilcon A hydrogel / comfilcon A silicone)
16125769|NCT01966770|Device|Pair 6 (omafilcon A / comfilcon A)|Randomized to contra lateral lens pair 6 (omafilcon A hydrogel / comfilcon A silicone)
16125770|NCT01966731|Drug|Hydroxyurea|Hydroxyurea will begin at 15-20 mg/kg PO daily. Six months of treatment will be given at the fixed dose, followed by another six months with dose escalation (2.5-5.0 mg/kg increments every 8 weeks) as tolerated to 20-30 mg/kg/day or MTD. The dose escalation phase will continue through the 12-month evaluation, after which hydroxyurea will continue in maintenance phase until the common treatment termination date. The daily dose will be calculated using available capsule sizes and a goal of 15-20 (17.5 ± 2.5) mg/kg/day based on weight. After 6 months of treatment, hydroxyurea will be titrated according to myelosuppression, and will be increased to 20-30 mg/kg/day or the maximum tolerated dose (MTD). Hydroxyurea dose escalation will occur in 5.0 ± 2.5 mg/kg/day increments.
16125771|NCT01966718|Drug|Repository corticotropin injection|An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances
16125772|NCT01966705|Behavioral|Cognitive Behavior Therapy, exposure and response prevention (Internet, guided)|"This intervention entails different exercises aimed at exposure to health anxiety stimuli.
~Participants are guided by a therapist. Treatment is delivered via the Internet."
16125773|NCT01966705|Behavioral|Cognitive Behavior Therapy, exposure and response prevention (Internet, unguided)|"This intervention entails different exercises aimed at exposure to health anxiety stimuli.
~Participants are not guided by a therapist. Treatment is delivered via the Internet."
16125774|NCT01966705|Behavioral|Cognitive Behavior Therapy, exposure and response prevention (Book, unguided)|"This intervention entails different exercises aimed at exposure to health anxiety stimuli.
~Participants are not guided by a therapist. Treatment is delivered in book form."
16125775|NCT01966692|Drug|Fluticasone Propionate Formulation 1|Fluticasone Propionate dry powder inhaler Formulation 1
16125776|NCT01966692|Drug|Fluticasone Propionate Formulation 2|Fluticasone Propionate dry powder inhaler Formulation 2
16125777|NCT01966692|Drug|Fluticasone Propionate Formulation 3|Fluticasone Propionate dry powder inhaler Formulation 3
16125778|NCT01966692|Drug|Fluticasone Propionate Formulation 3*|"Fluticasone Propionate dry powder inhaler Formulation 3*
~*(The asterisk) A different batch of the formulation 3 is given to the patient to ensure that the study is sufficiently powered to show bioequivalence between two batches of the same formulation."
16125779|NCT01966679|Drug|AZD7325|
16125780|NCT01966679|Drug|Placebo|
16125781|NCT01966666|Drug|TPI-287 2 mg/m2|2 mg/m2 of TPI-287 diluted with 500mL 0.9% sodium chloride. TPI-287 is a microtubule inhibitor belonging to the taxane diterpenoid (taxoid) family, and specifically to the abeotaxane class.
16125782|NCT01966666|Drug|TPI-287 6.3 mg/m2|6.3 mg/m2 of TPI-287 diluted with 500mL 0.9% sodium chloride. TPI-287 is a microtubule inhibitor belonging to the taxane diterpenoid (taxoid) family, and specifically to the abeotaxane class.
16125783|NCT01966666|Drug|TPI-287 20 mg/m2|20 mg/m2 of TPI-287 diluted with 500mL 0.9% sodium chloride. TPI-287 is a microtubule inhibitor belonging to the taxane diterpenoid (taxoid) family, and specifically to the abeotaxane class.
16125784|NCT01966666|Drug|Placebo|500mL 0.9% sodium chloride.
16125785|NCT01966653|Drug|nitrofurantoin|nitrofurantoin 100 mg po tid for 5 days
16125786|NCT01966653|Drug|fosfomycin|fosfomycin 3g po single dose
16125787|NCT01966640|Biological|Basophil Activation Test|blood sample for Basophil Activation Test
16125788|NCT01966627|Other|ogtt|oral glucose tolerance test
16125789|NCT01966627|Other|genotyping|genotyping to look for risk alleles
16125790|NCT01966627|Other|abdominal and liver magnetic resonance imaging|magnetic resonance imaging scan of abdomen and liver - abdominal and liver mri
16125791|NCT01966627|Other|stool sample|stool sample taken to investigate metabolites
16125792|NCT01966627|Other|liver biopsy|liver biopsy to examine for cellular change and steatosis
16125793|NCT01966614|Drug|PRX302|Single intraprostatic bilateral injection at a dose of 0.6 µg/g
16125794|NCT01966614|Other|Placebo|Single intraprostatic bilateral injection of vehicle only
16125795|NCT01966601|Drug|TRV027 Dose #1|TRV027 continuous intravenous infusion Dose #1
16125796|NCT01966601|Drug|TRV027 Dose #2|TRV027 continuous intravenous infusion Dose #2
16125797|NCT01966601|Drug|TRV027 Dose #3|TRV027 continuous intravenous infusion Dose #3
16125798|NCT01966601|Drug|Placebo|Placebo continuous intravenous infusion
16125799|NCT01966588|Other|Blood samples for whole genomic/transcriptomic sequencing|Participants in the Metabolic Arm will receive one blood draw, while participants in the Neutropenia Arm will receive a total of three blood draws: one at baseline, another 3 months later, and one 1 year later, with the possibility of further follow-up.
16125800|NCT01966588|Other|UKU Side Effect Rating Scale|Clinician-rated scale of psychic, neurological, autonomic, and other side effects related to psychotropic drugs; ratings are based on a 10-30 minute interview with each participant.
16125801|NCT01966575|Drug|Progestin|The experimental group will have no progestin prior to ovulation induction with clomiphene citrate, while the comparison group will have progestin medication prior to ovulation induction with clomiphene citrate, as per usual care.
16125829|NCT01966406|Other|No nasogastric tube|
16125857|NCT01966159|Device|SYNERGY Investigational Device|percutaneous coronary intervention
16125858|NCT01966159|Device|PE Plus Investigational Device|percutaneous coronary intervention
16125802|NCT01966562|Behavioral|WHOLE-BODY VIBRATION TRAINING|The vibration stimulus consisted of uniform vertical oscillations Power Plate® Next Generation (Power Plate North America, Northbrook, IL, USA). Subjects stood on the platform holding an quarter squat positions with the feet shoulder-width apart. Then, they perform ankle extensions with the following work sequence (establishing a rhythm of 100 b.p.m.: 1 b.p.m for the concentric phase; and 5 b.p.m. for the eccentric phase). After the familiarization 2-weeks, subjects trained 3 days per week for 6-months (72 sessions) using a vibrating training program that began with 5 sets and a frequency of 35 Hz per session and increasing by 11 sets and 40 Hz frequency the last month maintaining a series of parameters: vibration amplitude (4 mm) working time (60 s) and recovery time (60 s).
16125803|NCT01966562|Behavioral|MULTICOMPONENT TRAINING|This training combined vertical jumps and high intensity walking. During the first month, small reactive vertical jumps (without knee and ankle flexion) were performed. After the first month, subjects performed drop jumps progressively starting at a height of 5 cm and finishing at 25 cm at the end of the programme (increases of 5 cm each month). Additionally, the sets were increased from 4x10 jumps to 6x10 each week, finishing the last week with 4x10. In this sense, the drop jumps were the same each month but the total load (imposed by height) increased progressively. Regarding the aerobic exercise, the load increased progressively along the 6 months. The intensity ranged between 50-75% of reserve heart rate, the volume ranged between 30-60 min.
16125804|NCT01966549|Drug|CNTO 6785|CNTO 6785 (6 mg/kg) will be administered by intravenous (into a vein) infusion on Weeks 0, 2, 4, 8 and 12. Participants who weigh more than 100 kg will receive a dose of 600 mg of CNTO 6785.
16125805|NCT01966549|Drug|Placebo|Sterile, 5 percent dextrose will be used as the placebo in this study. Placebo will be administered by intravenous infusion on Weeks 0, 2, 4, 8 and 12.
16125806|NCT01966536|Procedure|CD133+ cells transplantation into ovarian artery of one ovary|
16125807|NCT01966523|Behavioral|Intervention|Provider Training: i. on-line education course and ii. algorithms and checklists. The course consists of 4 cases: 2 for urinary tract infection and 2 for lower respiratory tract infections with multiple choice questions and evidence-based feedback. To reinforce provider learning, posters displaying algorithms guiding appropriate antimicrobial initiation for infections will be placed in all nursing home units. Laminated pocket cards with the algorithms will be given to providers. Providers will complete simple checklists for each suspected infection throughout the study. B. Proxy Information: The printed material explains, in a lay fashion: i. the nature of infection in advanced dementia, ii. treatment options, iii. concerns about antimicrobial overuse, and iv. features of appropriate antimicrobial use.
16125808|NCT01966523|Other|Control|
16125809|NCT01966510|Other|Cord Blood Transplantation|
16125810|NCT01966484|Drug|Succinylcholine|Anaesthesia was induced and maintained with propofol(1-2mg/kg and 5mg/kg/h) and remifentanil (1µg/kg and 0,2µ/kg/min). The study arm is immobilized and a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. the patients receive the muscle relaxant according to the study group.
16125811|NCT01966484|Drug|Mivacurium|Anaesthesia was induced and maintained with propofol(1-2mg/kg and 5mg/kg/h) and remifentanil (1µg/kg and 0,2µ/kg/min). The study arm is immobilized and a dual electrode for peripheral nerve stimulation is placed over the ulnar nerve near the wrist. Neuromuscular monitoring is performed with accelerometry. the patients receive the muscle relaxant according to the study group.
16125812|NCT01966471|Drug|Trastuzumab Emtansine|Trastuzumab emtansine IV infusion (duration 90 minutes) will be administered at 3.6 mg/kg q3w for up to 18 cycles (1 cycle = 21 days).
16125813|NCT01966471|Drug|Trastuzumab|Trastuzumab IV infusion (duration 90 minutes) will be administered at 8 mg/kg loading dose followed by 6 mg/kg IV q3w for up to 18 cycles (1 cycle = 21 days).
16125814|NCT01966471|Drug|Pertuzumab|Pertuzumab infusion (duration 60 minutes) will be administered at 840 mg loading dose followed by 420 mg IV q3w for up to 18 cycles (1 cycle = 21 days).
16125815|NCT01966471|Drug|Paclitaxel|IV infusion of paclitaxel 80 mg/m^2 once weekly may be administered concurrently with trastuzumab in combination with pertuzumab for 12 weeks.
16125816|NCT01966471|Drug|Epirubicin|3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using epirubicin may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.
16125817|NCT01966471|Drug|Doxorubicin|3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using doxorubicin may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.
16125818|NCT01966471|Drug|Docetaxel|IV infusion either docetaxel every 3 weeks (q3w) (at 100 milligram per square meter [mg/m^2] for 3 cycles (1 cycle = 21 days); at 75 mg/m2 for 4 cycles; or start at 75 mg/m^2 in the first cycle and escalate to 100 mg/m^2 if no dose limiting toxicity occurs, for a total of 3 cycles at minimum) may be administered concurrently with trastuzumab in combination with pertuzumab.
16125819|NCT01966471|Drug|Cyclophosphamide|3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using cyclophosphamide (FEC) may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.
16125820|NCT01966471|Drug|5-Fluorouracil|3 to 4 cycles (1 cycle = 21 days) of standard of care anthracycline-based chemotherapy using 5-fluorouracil, may be administered in both Arms 1 and 2 as per discretion of the investigator and local prescribing information/institutional guidelines.
16125821|NCT01966458|Device|HeartWare® VAS (HVAD)|The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
16125822|NCT01966458|Device|Control LVAD|Any FDA-approved LVAD for destination therapy.
16125823|NCT01966445|Biological|GSK2849330|Solution containing 100 mg/millilter (mL) GSK2849330 for intravenous infusion
16125824|NCT01966432|Behavioral|Referral to Treatment|Patients receive a referral to treatment for substance abuse, with up to 2 follow-up phone calls. Patients are re-screened at followup visits.
16125825|NCT01966432|Behavioral|Brief Intervention|Patients receive a brief intervention aimed at reducing substance use, and are re-screened at followup visits.
16125826|NCT01966419|Drug|ornithine phenylacetate|Ornithine phenylacetate for continuous IV infusion at dose levels predicated on level of hepatic decompensation
16125827|NCT01966419|Drug|placebo intravenous infusion|Placebo for continuous IV infusion that is visually identical to the experimental product
16125830|NCT01966393|Other|60-hours intervention|Interventions will be conducted at the research centre (RC) or at the patient's home based on the patient's preference. If the study takes place at the RC, patients will be admitted at 7:00. If the study takes place at the patient's home, a research team member will be at the patient's home at 7:00. Closed-loop strategy will start at 8:00 on day 1 and end at 20:00 on day 3. During the interventions conducted at the RC, patients will have access to entertainment activities such as movies, video games, board games, foosball, etc. During the interventions conducted at the patient's home, patients will do their usual activities. For interventions conducted at the RC, patients will freely choose their meals from a large choice of prepared frozen meals. For interventions conducted at the patient's home, patients will freely choose their meals. Participants will be encouraged to conduct their usual physical activities whether they conduct the study at the RC or at the patient's home.
16125831|NCT01966380|Device|Leia|
16125832|NCT01966367|Biological|CD34 Stem Cell Selection Therapy|The CliniMACS (PLUS) Reagent System (Miltenyi CliniMACS CD34+ Cell Selection Device) will be used to remove T-cells from the peripheral blood stem cell transplant in order to decrease the risk of acute and chronic graft versus host disease (GVHD).
16125833|NCT01966354|Procedure|Ultrasound-guided Internal jugular venous approach|"The physician will use an ultrasound machine to perform an ultrasound-guided internal jugular venous cannulation: the needle and the vein will be visualized in real time in the ultrasound image to make the cannulation process easier and safer.
~In each one of three study arms, however, the ultrasound approach will be different depending on the axis on wich the vein is visualized (longitudinal, transversal or oblique) and the way the needle enters the ultrasound plane (in-plane or out of plane)."
16125834|NCT01966341|Behavioral|CBT/ Hypnotherapy|The CBT program will consist of 7 sessions that will encompass the following skills of Symptom monitoring, Stress Management, Coping Skills, Relaxation training, Problem solving, and Cognitive Restructuring.The hypnotherapy program will be modeled after the North Carolina Standardized Hypnosis Treatment for Irritable Bowel Syndrome
16125835|NCT01966341|Drug|Routine Management|Treatment with use of antispasmodics,laxatives, and/or bulking agents (fiber) +/- antibiotics.
16125836|NCT01966328|Drug|36% Resolvine Intravitreal Injection|36% Resolvine Intravitreal Injection
16125837|NCT01966328|Drug|9% Resolvine Intravitreal Injection|9% Resolvine Intravitreal Injection
16125838|NCT01966302|Drug|BPS-314d-MR|15-150 mcg po BID,
16125839|NCT01966289|Drug|CY|CY is administered intravenously at 200 mg/m2
16125840|NCT01966289|Biological|GVAX|GVAX is administered intradermally at 5E8 colon cancer cells + 5E7 GM-CSF secreting cells
16125841|NCT01966289|Drug|SGI-110|SGI-110 is administered subcutaneously at 60 mg/m2
16125842|NCT01966276|Drug|Methyl-P plus Nutrient Formula|"Week 1 (take the following together twice a day-at breakfast and lunch)
~One tablet of Methyl-P (5mg)
~Four tablets of CFS Nutrient Formula
~Week 2 to Week 12 (take the following together twice a day-at breakfast and lunch):
~Two tablets of Methyl-P (10mg)
~Four tablets of CFS Nutrient Formula"
16125843|NCT01966276|Drug|Methyl-P plus Nutrient matched placebos|"Week 1 (take the following together twice a day-at breakfast and lunch)
~One tablet of Methyl-P Placebo
~Four tablets of CFS Nutrient Placebo
~Week 2 to Week 12 (take the following together twice a day-at breakfast and lunch):
~Two tablets of Methyl-P Placebo
~Four tablets of CFS Nutrient Placebo"
16125844|NCT01966263|Procedure|LIA of the posterior capsule of the knee|the surgeon infiltrates the posterior capsule of the knee using 100 mL ropivacaine 0.2% with 0.5 mg epinephrine.
16125845|NCT01966263|Procedure|LIA of the anterior capsule of the knee|the surgeon infiltrates the anterior capsule of the knee using 50 mL ropivacaine 0.2% with 0.25 mg epinephrine.
16125846|NCT01966263|Procedure|LIA of the subcutaneous tissue of the knee|the surgeon infiltrates the subcutaneous tissue of the knee using 50 mL ropivacaine 0.2% before wound closure.
16125847|NCT01966263|Procedure|FNB with catheter|pre-operatively the anesthesiologist will ultrasound guided place a catheter close to the femoral nerve using sodium chloride (NaCl 0.9%) (no local anesthetic). During surgery, when the LIA of the posterior capsule is performed, 20 mL ropivacaine 0.2% will be administered through the catheter to create a femoral nerve block (FNB). Postoperatively patients will receive 20 mL ropivacaine 0.2% through the catheter 6 times daily for 24 hours
16125848|NCT01966250|Device|electroacupuncture and usual care|"Electroacupuncture: Using 0.25 mm (diameter) X 0.40 mm (length) sized disposable stainless steel needles, electric stimulation will be applied with an electronic stimulator (ES-160, ITO co. LTD, Japan) 2 times/week × 4 weeks. Stimulation will be applied with the current in biphasic wave form. Acupuncture points are Jia-ji (Ex-B2, L3-L5; bilateral) as necessary points and reasonable points (according to decision of practitioner) as accessory points. Each session lasts 15 minutes.
~Usual care: Physical therapy and patient education will be performed 2 times per week for 4 weeks. ICT lasts 15 minutes and Hot or Ice pack lasts 10minutes. Doctors will educate patient physiology, pathology, and epidemiology of low back pain. And also suitable postures and exercises for low back pain will be educated."
16125849|NCT01966250|Device|Usual care|Usual care: Physical therapy and patient education will be performed 2 times per week for 4 weeks. ICT lasts 15 minutes and Hot or Ice pack lasts 10minutes. Doctors will educate patient physiology, pathology, and epidemiology of low back pain. And also suitable postures and exercises for low back pain will be educated.
16125850|NCT01966224|Biological|CryJ2-DNA-LAMP plasmid vaccine by intramuscular injection|"Immunomic Therapeutics Inc. CryJ2-DNA-LAMP vaccine is a frozen product formulated in physiological saline and contains no preservative. The study product is packaged in a 1 ml volume in a 3 ml glass vial, with label complying with FDA requirements.
~Subjects will receive CryJ2-DNA-LAMP plasmid vaccine by intramuscular injection. The dosing regimen for the groups will be to receive one re-vaccination dose."
16125851|NCT01966198|Other|Tilt test|The experiment protocol consists of a sequence of passive postural changes gained with a tilt table, each of them lasting 10 minutes. The sequence consists of: (i) baseline recording in supine position; (ii) tilt at 45 degrees angle; (iii) recovery period in supine position; (iv) tilt at 90 degrees angle and (v) recovery in supine position.
16125852|NCT01966185|Other|Tutor function on|The simulator-integrated tutor function with volumetric green lighting of the intended volume to be drilled.
16125853|NCT01966172|Drug|Ibuprofen|oral ibuprofen 400mg 4 times daily
16125854|NCT01966172|Drug|Gabapentin|Oral Gabapentin 300mg twice daily
16125855|NCT01966172|Drug|Morphine|10 mg morphine orally 4 times daily
16125856|NCT01966172|Drug|Paracetamol|oral paracetamol 1000mg four times daily
16125859|NCT01966146|Device|Echography GE Healthcare Vivid E9|Echography GE Healthcare Vivid E9
16125860|NCT01966133|Drug|Ethiodized Oil + Doxorubicin|TACE using doxorubicin-lipiodol mixture
16125861|NCT01966120|Drug|BF-200 ALA gel|BF-200 ALA was applied over 1-2 fields of approximately 20 cm² in total, allowed to dry for approximately 10 minutes, and covered with occlusive tape material for 3 h.
16125862|NCT01966120|Drug|Placebo to BF-200 ALA gel|The reference product was a placebo (a nanoemulsion gel formulation similar to the Investigational Medicinal Product (IMP), but without the active ingredient). The placebo was packaged, assigned to each patient, and administered in the same way as the IMP.
16125863|NCT01966120|Procedure|Photodynamic therapy with BF-RhodoLED|After cleaning the lesions, the entire treatment field(s) were illuminated using the novel narrow spectrum BF-RhodoLED lamp, a red light illumination source (approximately 635 nm) developed by Biofrontera, until a total light dose of 37 J/cm² (per treated field) was achieved.
16125864|NCT01966107|Drug|Aclidinium Bromide|400 μg, twice per day, oral administration via a multi-dose dry-powder inhaler (DPI)
16125865|NCT01966107|Drug|Placebo|Dose matched placebo, twice per day, oral administration via a multi-dose dry-powder inhaler (DPI)
16125866|NCT01966081|Other|Blood sample|
16125867|NCT01966081|Other|tissue samples from abdominal subcutaneous adipose|
16125868|NCT01966068|Other|MyAsthma Web Portal|Parents will log on to the MyAsthma Web Portal up to three different times over a 6 month period. During each portal visit, parents will be asked to complete a survey which will include questions regarding their views on treatment preferences, goals, asthma control, and medications for their child with asthma.
16125869|NCT01966055|Drug|Solithromycin|
16125870|NCT01966042|Procedure|Local sedation|All subjects enrolled in the study underwent local sedation for bone marrow aspiration.
16125871|NCT01966042|Procedure|Bone Marrow Aspiration|All subjects enrolled in the study underwent bone marrow aspiration after they had been anesthetized from the posterior iliac crest. The sample was aspirated into a series of sterile syringes and brought to the cell processing room/laboratory. The processing was in accordance to the Standard Operating Procedure developed observing Good Practice Guidelines.
16125872|NCT01966042|Procedure|Minithoracotomy|The surgical procedure used as cardiac access route was the left anterolateral thoracotomy or left anterior minithoracotomy, depending on the segment of the left ventricle to be treated, allowing the good access to the viable myocardial areas.
16125873|NCT01966042|Biological|Autologous bone marrow mononuclear cells infusion|Once the subject had his or her chest opened and the coronary anatomy reviewed by examination of the pre-operatory nuclear scan to define the area of ischemia, the surgeon drew up the cells into a series of syringes and injected the entire contents of the cell preparation in a series of injections directly into the myocardium.
16125874|NCT01966029|Drug|BMN 110|All pateints receive treatment with BMN 110
16125875|NCT01966016|Procedure|Pacing|"In this study we intend to include patients that have indication to and are intended to undergo CRT implantation with an additional electrode on LV, that have inclusion criteria and have signed an informed consent.
~In this study we will include 20 patients for each study arm (overall 100)- each patient will have both treatment configurations and these two will be compared"
16125876|NCT01966003|Drug|Carboplatin|Administered at an area under the concentration-time curve (AUC) 6 by IV infusion Q3W
16125877|NCT01966003|Drug|Paclitaxel|Administered 200 mg/m² IV Q3W
16125878|NCT01966003|Drug|ABP 215|Administered 15 mg/kg Q3W by IV infusion
16125879|NCT01966003|Drug|Bevacizumab|Administered 15 mg/kg Q3W by IV infusion
16125880|NCT01965990|Other|NEP|A homemade very low-calorie protein-based formula by enteral route (8-French nasogastric tube) for 14 days. The administration was continuous (h-24) by a feeding pump. The formula was made up of a fixed amount of aminoacids and a variable amount of high-quality proteins: 1.2 g/kg (ideal body weight). Other components were: pro-lipolytic substances (coenzyme Q10 and L-carnitine), linseed oil, policosanol, fructo-oligo saccharides, potassium, sodium and magnesium chloride. The intervention included also the daily oral administration of a multivitamin-multimineral supplement, alkalizing substances (calcium carbonate, 1500 mg; magnesium carbonate, 850 mg; potassium bicarbonate, 500 mg; sodium bicarbonate, 1500 mg; potassium citrate, 500 mg) and herbal remedies. All patients were also prescribed treatment with a proton pump inhibitor and ursodeoxycholic acid. A minimum intake of 2 liters/day of unsweetened fluids was recommended (3 litres in case of a history of kidney stones).
16125881|NCT01965977|Drug|Bortezomib|Bortezomib 1.3mg/m2, on day 1 and 15 SC Repeat every month for 12months
16125882|NCT01965964|Procedure|Questionnaire|
16125883|NCT01965951|Other|Computerized Plasticity-based Adaptive Cognitive Training|Computerized Plasticity-based Adaptive Cognitive Training requiring a total maximum of 39 treatment sessions, 4-5 times weekly, ~30 mins each session.
16125884|NCT01965951|Other|Commercially available computerized training|Commercially available computerized training requiring a total maximum of 39 treatment sessions, 4-5 times weekly, ~30 mins each session.
16125885|NCT01965938|Device|RIFL (Rigid and Flexing Laryngoscope)|Patients in the RIFL group will undergo bronchoscopy using the Rigid and Flexing Laryngoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
16125886|NCT01965938|Device|Fiberoptic Bronchoscope|Patients in the control group will undergo bronchoscopy using the flexible fiberoptic bronchoscope. Once the carina is visualized with the bronchoscope, the endotracheal tube will be advanced, and the bronchoscope removed.
16125887|NCT01965925|Drug|Modafinil|Ratio of 2:1 subjects will be in the experimental arm receiving modafinil for 8 weeks.
16125888|NCT01965925|Drug|Placebo|For every randomly assigned 2 subjects receiving active drug, 1 will be randomly assigned to receive placebo for 8 weeks.
16125889|NCT01965912|Drug|Kuvan®|Kuvan® oral soluble tablet will be administered once daily along with Phenylalanine-restricted diet for a period of 7 years. Dosage of Kuvan® could range from 5 to 20 milligram per kilogram per day (mg/kg/day), as per Summary of Product Characteristics (SPC).
16125890|NCT01965899|Device|Insertable Cardiac Monitor Implant|The Reveal LINQ is a leadless device that is recommended to be implanted in the region of the thorax. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG. The device stores ECG recordings from the patient-activated episodes and ECG recordings from automatically detected arrhythmias. Documentation of episode occurrence will be retained.
16126022|NCT01964924|Drug|Akt Inhibitor GSK2141795|Given PO
16125891|NCT01965886|Procedure|Medial approach|Total knee replacement performed through a longitudinal incision medial to the patella
16125892|NCT01965886|Procedure|Keblish approach|Total knee replacement performed through a longitudinal incision lateral to the patella
16125893|NCT01965873|Dietary Supplement|Enteral nutrition|Same as arm description
16125894|NCT01965860|Other|additional curriculum (E-learning + simulation)|
16125895|NCT01965860|Other|additional E-learning|
16125896|NCT01965847|Behavioral|Medication therapy management|
16125897|NCT01965834|Drug|Fenofibrate|Upon screening, registration and enrollment, all subjects will receive Fenofibrate 160 mg orally daily for at least 2 months and may continue receiving study medication for as long as in the opinion of the investigator there is clinical benefit in doing so. Patients with calculated creatinine clearance < 50 mL/min will receive a reduced dose of 54 mg orally daily.
16125898|NCT01965821|Device|Continuous control of Pcuff followed by manual control|continuous control of tracheal cuff pressure using an electronic device for 24 h followed by manual control of cuff pressure using a manometer
16125899|NCT01965821|Device|Manual control of Pcuff followed by continuous control|24 h of manual control using a manometer followed by 24 h of continuous control using an electronic device
16125900|NCT01965808|Drug|LY2157299|Administered orally
16125901|NCT01965795|Dietary Supplement|Whole Coffee Fruit Concentrate (WCFC)|Neurfactor is a powder dietary supplement patented by Futureceuticals, in which the active ingredient is WCFC. It is hypothesized that the whole fruit of the coffee plant, Coffea arabica, has very unique, important benefits for healthy aging not available from regular coffee, other coffee extracts, green coffee bean extracts, caffeine, or other leading botanicals. NeuroFactor is thought to increase Brain-Derived Neurotrophic Factor, a protein vital for neuron development, repair and protection and essential for learning, memory, alertness, controlling body weight, and energy metabolism.
16125902|NCT01965795|Dietary Supplement|Nutrim|Nutrim is an oat bran powder Nutrim is hypothesized to bestow a number of benefits such as cardiovascular health, glucose management and healthy digestion. However, improved cognition is not one of the hypothesized benefits. This product is free of caffeine and stimulants.
16125903|NCT01965782|Drug|[^14C]-LY3023703|Administered orally
16125904|NCT01965769|Other|No gastric residual evaluation|Infants will not receive routine gastric residual evaluation prior to feeding.
16125905|NCT01965756|Drug|Metformin|
16125906|NCT01965756|Drug|Placebos|
16125907|NCT01965743|Behavioral|Contraception Information Packet|The intervention will consist of brief education about IUC and development of interpersonal skills, including how to initiate conversations about reproductive health issues in social settings and debunking common IUC myths
16125908|NCT01965730|Drug|epsilon-aminocaproic acid (EACA)|
16125911|NCT01965691|Dietary Supplement|Protein intake|"Oral consumption of eight hourly experimental meals-
~4 tracer free experimental meals containing a mixture of free amino acids and calories from protein free flavored liquid, protein free cookies and corn oil
~4 isotopically labeled experimental meals."
16125912|NCT01965678|Other|Osteopathic Manipulative Treatment|
16125913|NCT01965665|Device|MediHoney HCS dressing|
16125914|NCT01965652|Drug|Naldemedine|Naldemedine 0.2 mg tablet taken orally once a day
16125915|NCT01965652|Drug|Placebo|Placebo tablet taken orally once a day
16125916|NCT01965639|Other|Extension of Care|Clinical care will be delivered by a multidisciplinary team including (but not limited to) a physician, nurse practitioner, dietitian, pharmacist, licensed clinical social worker (LCSW), case manager, health educator and a community health worker in community settings including home visits and community based clinics.
16125917|NCT01965626|Drug|Oseltamivir|Oseltamivir 75 mg twice per day, 10 consecutive days
16125918|NCT01965626|Drug|Dexamethasone|HD-DXM (orally at 40 mg daily for 4d)
16125919|NCT01965613|Biological|Xilonix|IV
16125920|NCT01965600|Drug|PF-06282999|Tablet, 125 mg, TID, 3 days, 1 of 2 periods
16125921|NCT01965600|Drug|Placebo|Tablet, 0 mg, TID, 3 days, 1 of 2 periods
16125922|NCT01965600|Other|LPS|IV bolus, 4 ng/kg, 1 day, QD, 2 of 2 periods
16125923|NCT01965600|Drug|PF-06282999|Tablet, 500 mg, BID, 3 days, 1 of 2 periods
16125924|NCT01965600|Drug|Placebo|Tablet, 0 mg, BID, 3 days, 1 of 2 periods
16125925|NCT01965600|Other|LPS|IV bolus, 4 ng/kg, 1 day, QD, 2 of 2 periods
16125926|NCT01965587|Procedure|novasure mirena IUS combined|novasure mirena IUS combined
16125927|NCT01965574|Procedure|Trendelenburg position|
16125928|NCT01965561|Device|CRoC|Use of Combat Ready Clamp (CRoC)
16125929|NCT01965561|Device|AAJT|Use of Abdominal Aortic and Junctional Tourniquet (AAJT)
16125930|NCT01965561|Device|JETT|Use of Junctional Emergency Treatment Tool (JETT)
16125931|NCT01965561|Device|SJT|Use of SAM Junctional Tourniquet (SJT)
16125932|NCT01965548|Procedure|Treatment of splenic injury|"There are four possible treatments of splenic injury in this study:
~splenectomy
~splenic artery embolisation
~non-operative management
~any combination of the three treatments mentioned"
16125933|NCT01965535|Drug|LDV/SOF|LDV/SOF (90/400 mg) FDC tablet administered orally once daily
16125934|NCT01965535|Drug|RBV|RBV (200 mg tablets) administered orally in a divided daily dose based on weight (1000 mg per day for participants weighing < 75 kg; 1200 mg per day for participants weighing ≥ 75 kg)
16125935|NCT01965535|Drug|Placebo to match LDV/SOF|Placebo to match LDV/SOF administered orally once daily
16125936|NCT01965535|Drug|Placebo to match RBV|Placebo to match RBV administered orally in a divided daily dose
16125937|NCT01965522|Drug|Melatonin|Melatonin 20mg taken orally once daily. This is in the form of one capsule which contains two pills of melatonin, 10 mg each.
16125938|NCT01965522|Drug|Vitamin D|Vitamin D 2000 IU taken orally once daily. This is in the form of one capsule which contains two pills of vitamin D, 1000 IU each.
16125939|NCT01965522|Drug|Placebo (melatonin)|Overencapsulated placebo capsule which contains an inert substance. The capsule appears identical to the capsule which contains melatonin tablets.
16125940|NCT01965522|Drug|Placebo (vitamin D)|Overencapsulated placebo capsule which contains an inert substance. The capsule appears identical to the capsule which contains vitamin D tablets.
16125941|NCT01965509|Drug|PEX168 or placebo|injection has to administered subcutaneously weekly
16125942|NCT01965496|Drug|PEX168|A injection administered subcutaneously
16125943|NCT01965483|Radiation|once-weekly breast irradiation|
16125944|NCT01965470|Other|Combination Prevention|
16125945|NCT01965470|Other|Enhanced Care|
16125946|NCT01965431|Drug|BI 207127|Medium dose oral administration
16125947|NCT01965431|Drug|BI 207127 placebo|
16125948|NCT01965431|Drug|Faldaprevir placebo|
16125949|NCT01965431|Drug|Faldaprevir|Medium dose oral administration
16125950|NCT01965431|Drug|Moxifloxacin (Avalox®)|
16125951|NCT01965418|Drug|Fufang Biejia Ruangan Tablet|
16125952|NCT01965418|Drug|Placebo|
16125953|NCT01965405|Drug|Bupropion|Participant will receive a prescription for Bupropion hydrochloride and will self-administer according to dosage instructions from the study psychiatrist.
16125954|NCT01965405|Behavioral|Brief Counseling|Participants are provided with brief counseling for smoking cessation.
16125955|NCT01965405|Behavioral|High-magnitude prize contingency management|Prize based contingency management condition in which participants have the chance to win incentives (prizes) when they provide biological test results (expired carbon monoxide and cotinine) that are negative for recent smoking.
16125956|NCT01965405|Behavioral|Monitored support to quit smoking|Brief supportive sessions and monitoring of smoking cessation efforts.
16125957|NCT01965405|Behavioral|No additional treatment|No additional treatment will be given.
16125958|NCT01965405|Behavioral|Prize contingency management for abstinence|Prize based contingency management condition in which participants have the chance to win incentives (prizes) when they provide biological test results (expired carbon monoxide and cotinine) that are negative for recent smoking.
16125959|NCT01965405|Behavioral|Low intensity prize contingency management|Prize based contingency management condition in which participants have the chance to win incentives (prizes) when they provide biological test results (expired carbon monoxide and cotinine) that are negative for recent smoking.
16125960|NCT01965392|Other|Health education intervention|'Health education intervention'
16125961|NCT01965379|Other|Restriction on food containing phosphorus additives|The substitution of foods containing phosphorus additives for others with the same nutritional value for each individual of the study.
16125962|NCT01965379|Other|Standard care|The control group mantained the usual renal diet oriented prior to the study with a booklet.
16125963|NCT01965366|Behavioral|Virtual reality exposure therapy|Virtual reality exposure (VRE) therapy is a form of exposure therapy in which participants are helped to confront their traumatic memories in a therapeutic manner. They describe the events out loud and their therapist attempts to match what they are describing in the virtual reality. This is done repeatedly, allowing distress associated with these memories to decrease. Material that emerges during the VRE exposure is processed, or discussed, after the exposure, allowing participants to think about themselves and the event differently.
16125964|NCT01965366|Drug|0.5 mg DEX|A dose of DEX will be given the night before (approximately 10 hours before) each of 5 to 11 individual virtual reality exposure (VRE) therapy sessions.
16125965|NCT01965353|Drug|Panobinostat|- Panobinostat - single oral dose on days 1, 3, 5, 8, 10 and 12 and followed by a 9-day rest period.
16125966|NCT01965353|Drug|Dexamethasone|Dexamethasone - oral dose on Days 1, 2, 4, 5, 8, 9, 11 and 12 followed by a 9-day rest period
16125967|NCT01965353|Drug|Lenalidomide|Lenalidomide - daily oral dose on Days 1-14 followed by 7-day rest period
16125968|NCT01965353|Drug|Bortezomib|Bortezomib - subcutaneous injection, on Days 1, 4, 8, and 11 followed by a 10-day rest period. At least 72 hours should elapse between bortezomib doses, but if needed an interval of 70 hours is permitted
16125969|NCT01965340|Other|Systematic Therapeutic Drug Monitoring for the intervention group|
16125970|NCT01965327|Drug|Interferon Gamma-1b|"Subjects will begin by taking 10 mcg/m2 of IFN-g-1b for the first two weeks of the study. Dose will be escalated to 25 mcg/m2 of IFN-g-1b for weeks three and four of the study. Finally, the dose will be escalated to 50 mcg/m2 of IFN-g-1b for the last eight weeks of the study, which is the current dose approved by the FDA for children.
~All doses will be administered via subcutaneous injection."
16125971|NCT01965314|Other|Simulation based training|In addition to traditional training (as delivered to participants in the Traditional Training Group), participants in the Simulation Training Group will receive the following:- Following initial familiarization with the simulator SG participants will identify relevant structures and follow their course in the virtual arm. They will insert a virtual needle into the virtual environment and advance it using an in-plane technique towards various target structures. They will be given immediate directed computer generated feedback and offered the opportunity for repetitive, deliberate practice. The simulator, which SG participants will use, will comprise of a PHANTOM Desktop (http://www.sensable.com/), an haptic immersive workbench and the H3D API (http://www.sensegraphics.se/). The SG subject will scan and perform procedure specific tasks on a virtual arm. Training will continue until they reach proficiency levels set by experts using the same device
16125972|NCT01965314|Other|Traditional training|Subjects will be offered standardized multimodal training. This will be comprised of demonstration by suitably trained individuals of relevant anatomy using pre-existing cadaveric samples, performing ultrasound scans of the relevant areas on volunteers under expert supervision, and the practice of needle insertion under ultrasound-guidance using commonly used tissue phantoms (turkey breasts).
16125973|NCT01965301|Drug|BP1.5375 suspension|single oral dose
16125974|NCT01965301|Drug|Diphenhydramine|single oral dose of Diphenhydramine 50mg
16125975|NCT01965301|Drug|Placebo|Single oral dose
16125976|NCT01965288|Device|comfilcon A|test lens Pair(comfilcon A) or the control lens Pair(lotrafilcon B)
16125977|NCT01965288|Device|lotrafilcon B|test lens Pair(comfilcon A) or the control lens Pair(lotrafilcon B)
16125978|NCT01965275|Drug|Erlotinib or Gefitinib|Patients received the treatment with high-dose, pulsatile Erlotinib(600 mg every 4 days) or Gefitinib (1000 mg every 4 days) until disease progression or unacceptable toxicity occurred. The overall study period takes about 12 months
16125979|NCT01965262|Device|Hema-copolymer Lens|contact lens
16125980|NCT01965262|Device|etafilcon A Lens|contact lens
16125981|NCT01965249|Device|Long stitch|AWC with the long stitch technique using MonoMax USP 1, 150 cm loop, HRT48mm
16125982|NCT01965249|Device|Short Stitch|Short stitch suture technique using MonoMax USP 2/0, 150 cm, HR26 mm
16125983|NCT01965236|Dietary Supplement|sodium chloride|Patients are given 5 pills (1 g per pill) of sodium chloride per day for 6 weeks. After a one-week wash out period, a second period of 6 weeks is started with 5 placebo (microcrystalline cellulose) pills per day.
16125984|NCT01965236|Dietary Supplement|Placebo|
16125985|NCT01965223|Radiation|Multi-fraction SABR|Multi-fraction SABR; 48Gy delivered in 4 fractions, delivered over 2 weeks, with each fraction delivered 48 hours apart.
16125986|NCT01965223|Radiation|Single Fraction SABR|Single fraction SABR; 28Gy delivered in 1 fraction
16125987|NCT01965210|Other|Rye + high dose inulin + low dose gluten|In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
16125988|NCT01965210|Other|Rye + equal doses of inulin & gluten|In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
16125989|NCT01965210|Other|Rye + low dose inulin + high dose gluten|In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
16125990|NCT01965210|Other|Large non-supplemented rye|In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
16125991|NCT01965210|Other|Small non-supplemented rye|In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
16125992|NCT01965210|Other|Refined wheat bread|In a randomized cross-over design each subject receive one of six iso-caloric breakfasts on six different occasions, separated by 1 w wash-out.
16125993|NCT01965184|Behavioral|Cognitive-Behavioral Therapy for Anger and Aggression|
16125994|NCT01965184|Behavioral|Supportive Psychotherapy (SPT)|
16125995|NCT01965158|Drug|Naldemedine|Naldemedine 0.2 mg tablet taken orally once a day
16125996|NCT01965158|Drug|Placebo|Placebo tablet taken orally once a day
16125997|NCT01965145|Drug|Gevokizumab|Sterile solution administered subcutaneously
16125998|NCT01965145|Drug|Placebo|Sterile solution administered subcutaneously
16125999|NCT01965132|Drug|Biologic DMARD|
16126000|NCT01965119|Drug|Ruxolitinib|20 mg orally twice a day for 4 weeks (One cycle) Treatment continued until documented disease progression or unacceptable toxicity.
16126001|NCT01965106|Drug|QPI-1007 Injection|1.5 mg QPI-1007 Injection
16126002|NCT01965106|Drug|(including placebo)|Sham injection procedure
16126003|NCT01965093|Procedure|perioperative desaturation|children aged 0-5 years old who receive general anesthesia and developed perioperative desaturation
16126004|NCT01965093|Procedure|no perioperative desaturation|children aged 0-5 years who did not developed perioperative desaturation under general anesthesia
16126005|NCT01965080|Drug|Exemestane|One tablet Exemestane 25 mg daily
16126006|NCT01965067|Drug|sugammadex|"sugammadex 4.0 mg/kg is administered in deep block state(1 - 2 PTCs) in different temperature state
~Reversal effect of sugammadex in temperature state"
16126007|NCT01965054|Dietary Supplement|Fish Oil Supplement Group|1 liquid gel pill (440mg omega-3 fatty acids from fish oil) taken daily, enrollment to delivery
16126008|NCT01965041|Drug|aflibercept|2.0 mg intravitreal aflibercept injection is formulated as a sterile liquid to a final concentration of 40 mg/mL aflibercept in 5% sucrose, 10 mM sodium phosphate pH 6.3, 0.03% polysorbate 20, and 40 mM NaClvs. placebo
16126009|NCT01965028|Device|Transcranial random noise stimulation (tRNS)|High frequency tRNS (Neuroconn, Eldith DC-Stimulator Plus): 100-650Hz, 2mA, 20min, 10s ramp time, left and right auditory cortex, 5x7cm electrode with the inferior middle part over T3/T4 Arms: tRNS
16126010|NCT01965015|Device|Implantation of the V-Wave inter-atrial shunt|Percutaneous implantation of the V-Wave shunt by right heart catheterization (RHC) approach
16126011|NCT01965002|Device|MRgHIFU|The InSightec ExAblate 2000 magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system is a non-invasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue
16126012|NCT01965002|Drug|Aspirin|325 mg PO for deep venous thrombosis (DVT) prophylaxis initiated 2 hours prior to magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) treatment
16126013|NCT01965002|Drug|Enoxaparin|40 mg by subcutaneous (SC) administration, for deep venous thrombosis (DVT) prophylaxis initiated 2 hours prior to magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) treatment
16126014|NCT01964989|Biological|Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)|1 or 2 doses (naïve / non-naive subjects) 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months
16126015|NCT01964989|Biological|Non-adjuvanted Trivalent Influenza Vaccine (TIV) / Quadrivalent Influenza Vaccine (QIV)|1 or 2 doses (naïve / non-naive subjects) 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months
16126016|NCT01964963|Drug|Alogliptin|Alogliptin tablets
16126017|NCT01964937|Biological|DNA-HIV-PT123|The DNA-HIV-PT123 (containing clade C ZM96 gag and gp140 along with CN54 pol-nef) will be administered at a dose of 4 mg IM.
16126018|NCT01964937|Biological|NYVAC-HIV-PT1|The NYVAC-HIV-PT1 vaccine (containing clade C ZM96 gp140) will be administered at a dose of greater than or equal to 5×10^6 plaque-forming units (PFU)IM, for a planned maximum dose of 1.2×10^8 PFU.
16126019|NCT01964937|Biological|NYVAC-HIV-PT4|The NYVAC-HIV-PT4 vaccine (containing ZM96 gag-CN54 pol-nef) will be administered at a dose of greater than or equal to 5×10^6 PFU IM, for a planned maximum dose of 1.1×10^7 PFU.
16126020|NCT01964937|Biological|AIDSVAX B/E®|The AIDSVAX B/E ® vaccine will be administered as a 1 mL/600 mcg dose IM.
16126021|NCT01964937|Biological|Placebo vaccine|The placebo vaccine contains sodium chloride for injection USP, 0.9% and will be administered as a 1 mL injection IM.
16126023|NCT01964924|Other|Laboratory Biomarker Analysis|Correlative studies
16126024|NCT01964924|Drug|Trametinib|Given PO
16126025|NCT01964911|Drug|Ropivacaïne|"The first 3 days, analgesic treatments will be provided, as usual, depending on pain intensity (EN <3/10 : non opioids, EN 3-5/10 : weak opioids, EN>5/10 : strong opioids).
~If NRS is still over 5/10, continuous nerve block will be proposed. Patients will receive ropivacaïne, 5 mL/h during 7 days, with possibility of one bolus before wound care, through a stimulating catheter stimulong sono®.
~In association, analgesic treatments will be provided, as usual, depending on pain intensity (as during the first 3 days)."
16126026|NCT01964898|Behavioral|Behavioral Activation (BA)|5 to 9 Behavioral Activation (BA) counseling sessions focused on cessation and mood management. BA sessions will occur over the 12 weeks after hospital discharge.
16126027|NCT01964898|Behavioral|Standard Smoking Cessation Counseling|1 hour of in hospital counseling based on clinical guidelines
16126028|NCT01964898|Drug|Nicotine patch|An 8 week supply of the nicotine patch will be provided if the patient is cleared by their MD.
16126029|NCT01964898|Other|Printed Self-help materials for Smoking Cessation|
16126030|NCT01964885|Dietary Supplement|IQP-AS-105|
16126031|NCT01964885|Dietary Supplement|Placebo|
16126032|NCT01964872|Drug|JNJ-38877618: Part 1a|Single ascending dose administered orally in liquid formulation (Formulation A). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.
16126033|NCT01964872|Drug|JNJ-38877618: Part 1b|Single dose administered orally in capsule formulation (Formulation B). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.
16126034|NCT01964872|Drug|JNJ-38877618: Part 1c (optional)|Single dose administered orally in an alternative capsule formulation (Formulation C). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.
16126035|NCT01964872|Drug|JNJ-38877618: Part 2|Single ascending dose administered orally in the formulation selected based on Parts 1a, 1b, and 1c (if applicable). The planned dose range for Parts 1 and 2 will be 6 to 1200 mg.
16126036|NCT01964872|Drug|JNJ-38877618: Part 3|Multiple ascending dose and formulation determined in Part 2 (not to exceed 600 mg) administered orally.
16126037|NCT01964872|Drug|JNJ-38877618: Part 4 (optional)|Single dose and formulation as determined in Part 3 administered orally in older healthy male participant cohort.
16126038|NCT01964872|Drug|Placebo: Parts 1a, 2, 3, and 4 (optional)|Administered orally matched to study drug
16126039|NCT01964859|Biological|autologous skin fibroblasts|
16126040|NCT01964846|Dietary Supplement|Resveratrol, curcumin|
16126041|NCT01964846|Dietary Supplement|Placebo|
16126042|NCT01964833|Procedure|Periodontal treatment|"Periodontal treatment will consist of oral hygiene instructions, with the monitored orientation of brushing technique and recommendation of the daily use of dental floss. Calculus deposits will also be removed using ultrasound equipment with the appropriate tips for periodontics as well as scaling and planing with dental instruments, as recommended by the AAP (2001). Treatment will be carried out in two to four one-hour sessions.
~Patient will receive sham PDT."
16126043|NCT01964833|Procedure|Periodontal treatment and PDT|Patients will receive periodontal treatment as previously described and PDT. PDT will be administered at the end of the periodontal treatment session at sites with pocket depths equal to or greater than 4 mm. A diode laser will be used at the 660 nm wavelength, P= 100 mW, 9 J/point, D = 22 J/cm2 (per point). The photosensitizer (BlueMet 0.005 % DMC)will be deposited at the fundus of the periodontal pocket using a syringe. The laser will be applied to the mucosa over the oral epithelium that lines the periodontal pocket using an optical fiber.
16126044|NCT01964820|Behavioral|Positive Affect Skills Training|"Our intervention teaches 8 skills that research suggests lead to increased positive emotions, beginning with basic skills (recognizing and savoring positive events), and progressing to more complex ones such as goal- setting and acts of kindness. Established skills such as reappraising negative thoughts are also taught, in the context of cultivating positive emotions and coping with stress.
~The skills are taught over 5 weeks, with one or more new skills introduced each week. A week consists of 1-2 days of didactic material and 5-6 days of real-life skills practice and reporting.
~For a full description, see A positive affect intervention for people experiencing health-related stress: development and non-randomized pilot test (Moskowitz et al., 2012)."
16126045|NCT01964807|Other|Cigarette, NIDA test type with 16.6 mg nicotine|Smoke a single cigarette for up to 10 minutes
16126046|NCT01964807|Other|Cigarette, NIDA test type with <0.45 mg nicotine|Smoke a single low-nicotine cigarette for up to 10 minutes
16126047|NCT01964807|Other|Electronic cigarette with 18 mg/ml nicotine|Use electronic cigarette with 18 mg/ml nicotine for 30 minutes
16126048|NCT01964807|Other|Electronic Cigarette with no nicotine|Use electronic cigarette with no nicotine for 30 minutes
16126049|NCT01964807|Other|Moist snuff|Use moist snuff for 30 minutes
16126050|NCT01964807|Other|Sham Smoking|Sham smoking or e-cigarette use consists of puffing on a drinking straw for 10 minutes
16126051|NCT01964807|Other|Secondhand cigarette smoke (SHS)|180-minute exposure to SHS generated by controlled dilution of smoke from machine-smoked cigarettes
16126052|NCT01964807|Other|Conditioned, filtered air|Exposure to conditioned, filtered air for 180 minutes
16126053|NCT01964807|Other|Sham Moist Snuff|Chew gum for 30 minutes
16126054|NCT01964781|Drug|Tranexamic Acid|Topical administration - does it reduce surgical bleeding?
16126055|NCT01964781|Drug|Bupivacaine|Topical Bupivacaine- does it reduce surgical pain?
16126056|NCT01964781|Drug|Adrenaline|Topical adrenaline - does it reduce bleeding on its own, and does it enhance the effect of tranexamic acid?
16126057|NCT01964781|Drug|tranexamic acid plus saline|
16126058|NCT01964781|Drug|saline|
16126059|NCT01964768|Other|Skin prick-test|
16126060|NCT01964755|Drug|Doxorubicin|Doxorubicin 20 mg/m2 intravenously will be administered on Day 1 in patients with systemic (non-primary CNS) lymphoma as per institutional guidelines
16126061|NCT01964755|Drug|Methotrexate|Methotrexate administered starting on Day 2, per study protocol.
16126062|NCT01964755|Drug|Leucovorin|Leucovorin administered first intravenously 24 hours after start of Methotrexate infusion, then orally every 6 hours for at least 10 doses, per study protocol.
16126063|NCT01964755|Biological|Hydroxyurea|Hydroxyurea administered orally twice daily starting on Day 2, and continuing for a total of 10 doses, per study protocol
16126158|NCT01964092|Behavioral|Ordinary employment schemes|
16126064|NCT01964755|Drug|Zidovudine|Zidovudine administered first intravenously on Day 2, and then orally twice daily for 10 doses, per study protocol.
16126065|NCT01964755|Drug|Rituximab|Rituximab is optional and will be administered to study participants, per study protocol.
16126066|NCT01964742|Genetic|blood samples|
16126067|NCT01964729|Device|rTMS|The participants will be randomized into placebo-sham or rTMS or treatment groups for 10 consecutive sessions, at 10 Hz frequency.
16126068|NCT01964729|Device|Sham rTMS|Sham Comparator: For the placebo-controlled condition, we will use the same TMS equipment coupled with a placebo coil that produces the same active sound produced by the active coil.
16126069|NCT01964716|Biological|13-valent pneumococcal conjugate vaccine|Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (multidose vial formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.
16126070|NCT01964716|Biological|13-valent pneumococcal conjugate vaccine|Subjects will receive three doses (0.5 mL each) of 13-valent pneumococcal conjugate vaccine (single-dose syringe formulation) in the anterolateral thigh muscle of the left leg. Dose 1 is administered between 42 and 70 days of age, dose 2 is administered 28 to 42 days after dose 1, dose 3 is administered 28 to 42 days after dose 2.
16126071|NCT01964703|Drug|Rubus occidentalis extract|
16126072|NCT01964677|Device|Magnetic Resonance Image-guided High Intensity Focused Ultrasound (MR-HIFU)|
16126073|NCT01964664|Behavioral|Mindfulness Meditation Training|6-week, one-on-one meditation training. 90-minute home study visit once per week with research assistant. Learn Mindfulness-Based Cognitive Therapy curriculum and mindfulness techniques, and are asked to practice guided meditations 30-45 minutes each day.
16126074|NCT01964664|Behavioral|Audio Group|Listen to 30-minute podcasts on a daily basis, and discuss podcasts with research assistant at 90-minute weekly home visits. 6 weeks total.
16126075|NCT01964651|Drug|JNJ-42165279 50 mg|JNJ-42165279 50 mg orally administered once daily for 10 days.
16126076|NCT01964651|Drug|JNJ-42165279 100 mg|JNJ-42165279 100 mg orally administered once daily for 10 days.
16126077|NCT01964651|Drug|JNJ-42165279 30 mg|JNJ-42165279 30 mg orally administered once daily for 10 days.
16126078|NCT01964651|Drug|Placebo|Matching placebo orally administered once daily for 10 days.
16126079|NCT01964638|Procedure|Targeted Biopsy|
16126080|NCT01964625|Other|PET-CT Scan|PET-CT scan will be done at baseline (per standard of care), at onset and confirmation of chronic GvHD and after initiation of therapy to assess response.
16126081|NCT01964599|Dietary Supplement|PF-RS|n=20 will consume PF-RS containing 30 g potato fiber for 14 days and will consume a control containing no fiber for 14 days.
16126082|NCT01964599|Dietary Supplement|PF-RO1|n=20 will consume PF-RO1 containing 30 g potato fiber for 14 days and will consume a control containing no fiber for 14 days.
16126083|NCT01964599|Dietary Supplement|PF-RO2|n=20 will consume PF-RO2 containing 30 g potato fiber for 14 days and then will consume a control containing no fiber for 14 days.
16126084|NCT01964599|Dietary Supplement|Control|
16126085|NCT01964586|Drug|Dexmedetomidine|2 mcg/kg dexmedetomidine was administered 10 minutes before the surgery by infiltration to the both side of the nasal septum.
16126086|NCT01964586|Drug|Lidocaine|10 ml 2% lidocaine was administered 10 minutes before the surgery by infiltration to the both side of the nasal septum.
16126087|NCT01964586|Drug|Adrenaline|12.5 mcg/ml 10 ml adrenaline was administered 10 minutes before the surgery by infiltration to the both side of the nasal septum.
16126088|NCT01964573|Drug|Rotigotine|"Day 1-3: 2 mg patch once daily
~Day 4-6: 4 mg patch once daily"
16126089|NCT01964573|Other|Placebo|"Placebo patches matching with Rotigotine 2 mg patches and 4 mg patches.
~Frequency:
~Day 1-3: 2 mg patch once daily
~Day 4-6: 4 mg patch once daily"
16126090|NCT01964560|Drug|Lacosamide|"Pharmaceutical form: oral solution
~Concentration: 1 mg/kg - 6 mg/kg BID (2 mg/kg/day - 12 mg/ kg/day)
~Route of administration: oral use"
16126091|NCT01964560|Drug|Lacosamide|"Pharmaceutical form: tablet
~Concentration: 50 mg - 300 mg BID (100 mg/day - 600 mg/day)
~Route of administration: oral use"
16126092|NCT01964547|Drug|Sativex|Patients self-administered their allocated randomized treatment on an outpatient basis, up to a maximum of 12 sprays to the oral mucosa per day (following an initial titration period).
16126093|NCT01964547|Drug|Placebo|Patients self-administered their allocated randomized treatment on an outpatient basis, up to a maximum of 12 sprays to the oral mucosa per day (following an initial titration period).
16126094|NCT01964534|Drug|ABI-007|ABI-007 : 125 mg/m² IV /30min (day 1, day 8, day 15)
16126095|NCT01964534|Drug|Gemcitabine|1000 mg/m² IV /30min (day 1, day 8, day 15)
16126096|NCT01964534|Drug|simplified LV5FU2|Folinic acid: 400 mg/m² IV /2h (day 1, day 15) Bolus 5-FU: 400 mg/m² IV /15min (day 1, day 15) 5-FU infusion: 2400 mg/m² IV /46h (day 1-2, day 15-16)
16126097|NCT01964521|Device|Mepilex Transfer Ag|A soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound healing environment and has antimicrobial properties.
16126098|NCT01964508|Other|Fine needle aspiration|
16126099|NCT01964495|Drug|Discontinuation of treatment according to CRP levels|The cutoff point is a CRP below 100 mg/L and a reduction to 50% of the initial value.
16126100|NCT01964495|Drug|Discontinuation of treatment according to PCT levels|The cutoff point is a PCT below 0.25 mcg/L or a reduction to 10% of the initial value.
16126101|NCT01964495|Drug|Treatment according to current guidelines|Often a 7 days course of antibiotics, treatment may be extended if the attending physician deems it necessary.
16126102|NCT01964482|Other|Strength training|Strength training followed by intake of a protein drink
16126103|NCT01964469|Behavioral|mobile & web-based action plan|Evidence-based best practice primary care asthma program including asthma self-management education replacing the written self-management action plan with the Breathe mobile health and web-based application
16126104|NCT01964456|Other|Joint perception task|
16126105|NCT01964456|Behavioral|Body Shape Questionnaire|
16126106|NCT01964456|Other|Measure of the heart rate|
16126107|NCT01964430|Drug|nab-Paclitaxel|nab-Paclitaxel 125 mg/m^2 on Days 1, 8, and 15 of every 28 day treatment cycle by intravenous (IV) administration for a total of 6 cycles.
16126510|NCT01961466|Other|psychological and social self-administered questionnaires|
16126108|NCT01964430|Drug|Gemcitabine|Gemcitabine 1000 mg/m^2 on Days 1, 8, and 15 of a 28 day cycle by IV administration for a total of 6 cycles.
16126109|NCT01964417|Drug|Colonoscopy after bowel cleansing|
16126110|NCT01964404|Drug|Marijuana|Smoked plant with THC
16126111|NCT01964404|Drug|Dronabinol|Capsule with THC
16126112|NCT01964404|Drug|Placebo|Capsule with no active ingredient
16126113|NCT01964391|Drug|Trastuzumab|Trastuzumab will be administered subcutaneously at a fixed dose of 600 mg (irrespective of body weight) every 3 weeks for 1 year (adjuvant or neo-adjuvant plus adjuvant therapy).
16126114|NCT01964391|Drug|Doxorubicin|Doxorubicin will be administered in combination with trastuzumab and cyclophosphamide in the adjuvant setting as per local Product Information and the investigator's discretion.
16126115|NCT01964391|Drug|Cyclophosphamide|Cyclophosphamide will be administered in combination with trastuzumab and doxorubicin in the adjuvant setting as per local Product Information and the investigator's discretion.
16126116|NCT01964391|Drug|Paclitaxel|Paclitaxel will be administered in combination with trastuzumab in the adjuvant setting as per local Product Information and the investigator's discretion.
16126117|NCT01964391|Drug|Docetaxel|Docetaxel will be administered in combination with trastuzumab in the adjuvant setting as per local Product Information and the investigator's discretion.
16126118|NCT01964391|Drug|Carboplatin|Carboplatin will be administered in combination with trastuzumab and docetaxel in the adjuvant setting as per local Product Information and the investigator's discretion.
16126119|NCT01964391|Drug|Neo-adjuvant chemotherapy|Neo-adjuvant chemotherapy will be administered according to local guidelines in combination with trastuzumab in the neo-adjuvant setting. The study protocol does not mention any specific neo-adjuvant chemotherapy drug names.
16126120|NCT01964378|Drug|Cebranopadol|Participant will take one or two tablet(s) of cebranopadol in the morning and one or two placebo double-dummy morphine-like capsule(s) in the morning and the evening.
16126121|NCT01964378|Drug|Morphine Prolonged Release|Participant will take one or two morphine capsule(s) in the morning and in the evening and one or two placebo double-dummy cebranopadol-like tablet(s) in the morning.
16126122|NCT01964365|Drug|Cresto 20mg|tablet, rosuvastatin 20mg
16126123|NCT01964365|Drug|Fenofibric acid 135mg|capsule, fenofibric acid 135mg
16126124|NCT01964365|Drug|Cresto 20mg, Fenofibric acid 135mg|rosuvastatin 20mg, Fenofibric acid 135mg
16126125|NCT01964352|Drug|tiotropium|fixed dose combination
16126126|NCT01964352|Drug|placebo|
16126127|NCT01964352|Drug|olodaterol|fixed dose combination
16126128|NCT01964352|Drug|tiotropium|fixed dose combination
16126129|NCT01964352|Drug|tiotropium|
16126130|NCT01964352|Drug|olodaterol|fixed dose combination
16126131|NCT01964339|Other|BMI greater than or equal to 30kg/m2 scheduled for PSG. Undergo blood draw (venous blood gas and metabolic panel) and data collection from PSG study.|Venous blood gas, basic metabolic panel, PSG variable data collection.
16126132|NCT01964339|Other|BMI greater than or equal to 30kg/m2 scheduled for PSG. Undergo blood draw (arterial blood gas and metabolic panel) and data collection from PSG study.|Arterial blood gas, basic metabolic panel, PSG variable data collection
16126133|NCT01964326|Drug|Atorvastatin calcium 10 mg|Atorvastatin calcium 10 mg tablet to be administered orally every day
16126134|NCT01964300|Biological|peginterferon alfa-2b|Given subcutaneously (SC)
16126135|NCT01964300|Other|laboratory biomarker analysis|Correlative studies
16126136|NCT01964287|Drug|GEMBRAX|
16126137|NCT01964287|Drug|FOLFIRINOX|
16126138|NCT01964261|Device|Neural Prosthetic System 2 (NPS2)|The NPS2 comprises 2 NeuroPort Arrays (Pt) and 1 NeuroPort Array (SIROF). Each Pt array is comprised of 100 1.5 mm microelectrodes organized on a 4mm x 4mm silicon base that is 0.25 mm thick. Each microelectrode is insulated with Parylene-C polymer and is electrically isolated from neighboring electrodes by non-conducting glass. Of the 100 electrodes, 96 are wire bonded using 25m gold alloy insulated wires sealed with a silicone elastomer. The wire bundle is potted to a printed circuit board with epoxy, the circuit board is inserted into the Patient Pedestal (percutaneous connector), and then the Patient Pedestal is filled with silicone elastomer. Two fine platinum reference wires are also attached to the Patient Pedestal. The Patient Pedestal is 19 mm wide at the skin interface. The SIROF Array is similar to the Pt Array, the only difference is a change in the tip of the electrodes from platinum to sputtered iridium oxide film (SIROF).
16126139|NCT01964248|Drug|Placebo|Placebo cream applied 2 hours before blood sample
16126140|NCT01964248|Drug|lidocaïne/prilocaïne 5%|Application cream lidocaïne/prilocaïne (5%) 2 hours before blood sample
16126141|NCT01964235|Drug|INC280|INC280 will be administered orally and continuously on a twice a day dosing schedule.
16126142|NCT01964235|Drug|Placebo|Placebo will be administered orally and continuously on a twice a day dosing schedule.
16126143|NCT01964222|Behavioral|Decision Aid (DA)|Participants will be shown (on a computer) a targeted, web-based decision aid focused on the topic of clinical trials in addition to usual care.
16126144|NCT01964196|Drug|ASP1517|Oral administration
16126145|NCT01964196|Drug|Placebo|Oral
16126146|NCT01964183|Drug|tolterodine|Oral
16126147|NCT01964183|Drug|mirabegron|Oral
16126148|NCT01964170|Drug|degarelix|subcutaneous
16126149|NCT01964170|Drug|Goserelin|subcutaneous
16126150|NCT01964157|Drug|LDK378|LDK378 750mg oral administration and continuously (28-day treatment schedule as one treatment cycle)
16126151|NCT01964144|Drug|Dovitinib|Dovitinib 500mg (5 capsules x 100 mg/day) for 5 consecutive days and 2 days rest
16126152|NCT01964131|Drug|D961H sachet 20 mg|"Each subject will be randomised evenly to one of Treatment: A-->B (Sequence 1) or Treatment: B-->A (Sequence 2).
~Treatment A: D961H sachet 20 mg Treatment B: D961H HPMC capsule 20 mg"
16126153|NCT01964131|Drug|D961H HPMC capsule 20 mg|"Each subject will be randomised evenly to one of Treatment: A-->B (Sequence 1) or Treatment: B-->A (Sequence 2). Treatment A: D961H sachet 20 mg Treatment B: D961H HPMC capsule 20 mg"
16126154|NCT01964118|Other|Intermittent Fasting group|Intermittent fasting for 12 months
16126155|NCT01964118|Other|control group|usual diet for 6 months and intermittent fasting for other 6 months
16126156|NCT01964105|Device|3D Imaging|
16126157|NCT01964092|Behavioral|Individual Placement and Support|
16126159|NCT01964079|Drug|Amlodipine|Eligible subjects will be randomized 1:1 to either an amlodipine or a losartan group by a computer-generated random number table. For patients who fail to respond to 5 mg amlodipine, the dose will be titrated up to 10 mg amlodipine. At subsequent visits, additional antihypertensive therapy (hydrochlorothiazide) will be added if systolic (>140 mmHg) or diastolic (>90 mmHg) BP is inadequate. Study drugs are administered once a day for 24 weeks. The dose will be titrated up if SBP is over 90 mmHg or there are no symptoms of hypotension (syncope, loss of consciousness, or orthostatic hypotension). If up-titration is not tolerable, because of side effects or hypotension, the previous dose will be administered as the final tolerable dose.
16126160|NCT01964079|Drug|Losartan|Eligible subjects will be randomized 1:1 to either an amlodipine or a losartan group by a computer-generated random number table. For patients who fail to respond to 50 mg losartan, the dose will be titrated up to 100 mg losartan. At subsequent visits, additional antihypertensive therapy (hydrochlorothiazide) will be added if systolic (>140 mmHg) or diastolic (>90 mmHg) BP is inadequate. Study drugs are administered once a day for 24 weeks. The dose will be titrated up if SBP is over 90 mmHg or there are no symptoms of hypotension (syncope, loss of consciousness, or orthostatic hypotension). If up-titration is not tolerable, because of side effects or hypotension, the previous dose will be administered as the final tolerable dose.
16126161|NCT01964066|Procedure|ERCP|Endoscopic retrograde cholangiopancreatography balloon dilatation
16126162|NCT01964066|Procedure|Thoracic epidural analgesia|Thoracic epidural analgesia between thoracic vertebrae VII-VIII (Ropivacaine 0.5%-10ml)
16126163|NCT01964066|Procedure|Premedication|For premedication used trimeperidine 2%-1ml intravenously.
16126164|NCT01964053|Behavioral|PATCH intervention|The intervention group will receive usual care and the PATCH intervention. The intervention is comprised of two phases in which the in-hospital discharge education session is followed by 12 weeks of post-discharge education sessions delivered by telephone. The focus of this study is to test the mechanism of the proposed patient activation intervention on HF self-management adherence and associated health outcomes.
16126165|NCT01964053|Behavioral|Usual care|Usual care refers to the standardized discharge written information and scheduled doctor appointments. Standardized discharge instruction, as recommended by CMS and the Joint Commission, includes: activity level, diet, discharge medications, follow-up doctor appointment, weight monitoring, and what to do if symptoms worsen.113 No further follow-ups are routinely done by the hospital and patients are told to see their primary care provider if problems occur.
16126166|NCT01964040|Drug|peri-neural dexmedetomidine as adjuvant to bupivacaine in femoral nerve block|"ultrasound quided femoral nerve block with injection of 15 ml bupivacaine 0.5% perineurally with 0.5 ml dexmedetomidine (50 microgram) either perineurally or subcutaneously.
~After adequate assessment of femoral nerve block, patients will be transferred to the operating room to receive a standard general anesthesia"
16126167|NCT01964027|Drug|second line chemoregime for advanced gastric cancer|Irinotecan(Camptosar)150mg /m2 d1,（intravenous infusion of 30-90 minutes) + epirubicin(Pharmorubicin) 50mg/m2 (total dose does not exceed 700mg/m2) every 21days for 1 treatment * 6 cycles as the second line chemoregime for advanced gastric cancer
16126168|NCT01964014|Drug|advagrf|"All enrolled subjects will discontinue the existing Tacrolimus preparations for 6 months from enrollment and be converted to Extended Release Tacrolimus at a biologically equivalent dose. They will also discontinue enteric-coated mycophenolate sdium or mycophenolate sodium and be treated with Sirolimus and observed.
~advagrf+sirolimus one time to eat."
16126169|NCT01964001|Dietary Supplement|Vitamin B-6|Vitamin B-6 50 mg/d
16126170|NCT01964001|Dietary Supplement|Coenzyme Q10|Coenzyme Q10 300 mg
16126171|NCT01964001|Dietary Supplement|Vitamin B-6+Coenzyme Q10|Vitamin B-6 (50 mg/d) and Coenzyme Q10 (300 mg/d)
16126172|NCT01964001|Other|Placebo|starch
16126173|NCT01963988|Procedure|Transurethral Coagulation (TUC)|
16126174|NCT01963988|Procedure|Transurethral Resection(TUR)|
16126175|NCT01963962|Drug|Copper IUD|
16126176|NCT01963962|Drug|Levonorgestrel IUD|
16126177|NCT01963936|Device|Supreme LMA|
16126178|NCT01963936|Device|Facial mask|
16126179|NCT01963923|Behavioral|Pulmonary Rehabilitation Program|The pulmonary rehabilitation program includes an endurance training with a cycloergometer, a strength training with elastic bands and two dairy sessions of incentive spirometry with a volume-oriented device.
16126180|NCT01963910|Drug|30% Mannitol in vehicle cream|applied to one half of the upper lip following removal of capsaicin cream.
16126181|NCT01963910|Drug|vehicle cream|application to the other half of the upper lip following capsaicin cream removal
16126182|NCT01963884|Procedure|Tooth Extraction|Tooth from the maxillary anterior area extracted and alveolar socket remains intact
16126183|NCT01963884|Radiation|Cone-Beam technology evaluation|Patient is submitted to a localized cone-beam image before tooth extraction and 6 month later, prior to implant installation.
16126184|NCT01963884|Other|Measure Alveolar Socket Remodeling|In a computer, cone-beam images are superimposed to measure total the amount of ridge dimension
16126185|NCT01963871|Other|Yoga|Twice weekly one hour sessions of Hatha Yoga for 12 weeks
16126186|NCT01963858|Procedure|Functional relaxation|Functional relaxation during colonoscopy
16126187|NCT01963858|Procedure|No relaxation|No relaxation during colonoscopy
16126188|NCT01963845|Drug|Sitagliptin|
16126189|NCT01963845|Drug|Placebo|
16126190|NCT01963832|Drug|Fluoxetine|
16126191|NCT01963832|Drug|Placebo|
16126192|NCT01963832|Procedure|eCMIT|
16126193|NCT01963832|Procedure|Usual Care|
16126194|NCT01963819|Other|Endometrial biopsy|The endometrial biopsy will be done in the luteal phase (cycle day 18-22) prior to the treatment cycle (antagonist)
16126236|NCT01963494|Behavioral|Individual planning intervention|Target persons form action plans on their own.
16126237|NCT01963494|Behavioral|General motivational treatment|Both partners are asked to read a brochure that aims at enhancing their motivation to increase levels of moderate physical activity. They respond to a quiz afterwards.
16126238|NCT01963481|Drug|Exemestane|
16126239|NCT01963481|Drug|Cyclophosphamide|
16126418|NCT01962207|Biological|Meningococcal vaccine GSK134612|One dose administered intramuscularly (IM) in the deltoid of the non-dominant arm
16126511|NCT01961453|Drug|Isosorbide Mononitrate, sustained release|60 mg if Titration Stage 1 OR 120 mg if Titration Stage 2
16126195|NCT01963806|Behavioral|Smartphone-supplemented iCBT|"The Internet-administered cognitive behavioural self-help program (iCBT) will be divided into 10 weekly, progressively available modules covering CBT and Acceptance and Commitment Therapy (ACT) conceptualisations of anxiety disorders, as well as more specific therapeutic techniques such as cognitive restructuring, exposure training, attention and breathing exercises and relapse prevention . Each module also includes writing exercises.
~Also included is a tailored smartphone application. Briefly, the application allows the user to access, create and modify a personal database of behaviours and check-off these behaviours immediately when completed. Frequency of carried-out behaviours are recorded and displayed as statistics. The application also allows users to browse and search a database of behaviours uploaded by other study participants, providing both inspiration and a sense of social support."
16126196|NCT01963806|Behavioral|Therapist support|The role of the therapists will be to provide feedback on the written exercises of each treatment module, as well as to provide support and encouragement. As a rule of thumb, the therapists will devote 15 minutes per participant and week.
16126197|NCT01963806|Other|Active waiting list|Completes measurements at day 24 and 48 and at the end of the initial treatment period, otherwise no activity until crossover.
16126198|NCT01963793|Drug|Aprepitant|Aprepitant gel (10 mg/g)
16126199|NCT01963793|Drug|Placebo|gel without active component
16126200|NCT01963780|Device|OCS Lung Preservation|
16126201|NCT01963767|Drug|NT-020|"Recommended intake of NT-020 (NutraStem®) is two (2) capsules daily. This comprises Vitamin D3 (2000 IU), BioVin® (40 mg) and the proprietary blend (900mg). This recommended intake was calculated from doses analyzed in scientific research and based on the dose within the submitted patent.
~Scientific description of the ingredients of the product per a 2 capsule dose Vitamin D3 (as cholecalciferol) - 2000 IU BioVin® Grape Extract - 40 mg Proprietary Blend - 900mg Green Tea Extract (Camellia sinensis) Wild Blueberries* (whole fruit) Carnosine VitaBlue® Wild Blueberry Extract*
~Vaccinium angustifolium
~Other Ingredients:
~Magnesium stearate, Cellulose (vegetarian capsules) Contains no yeast, wheat, corn, milk, egg, soy, glutens, artificial colors or flavors, added sugar, starch or preservatives."
16126202|NCT01963767|Dietary Supplement|Placebo|
16126203|NCT01963754|Device|Dental Implants in Posterior Mandible|Place dental implants in posterior mandible, distal from canine, according to manufacturer recommendations
16126204|NCT01963754|Drug|Subperiosteal 1:100.000 Articaine 4% epinephrine|Administration of subperiosteal anesthesia for implant placement
16126205|NCT01963754|Drug|Loco-regional 1:100.000 Articaine 4% epinephrine|Administer loco-regional anesthesia for implant placement in posterior mandible
16126206|NCT01963741|Drug|leukotriene D4|Nasal challenge using 16% ethanol diluent, the concentration of which corresponded to the highest concentration of LTD4, was undertaken for exclusion of subjects hypersensitive to ethanol or saline. The LTD4 challenge could be initiated provided that NAR increase was <30%. Ranges of 4 to 16 mcg.mL-1 LTD4 diluents were applied for a double-fold increment approach at intervals of 6 minutes.
16126207|NCT01963741|Drug|histamine|Nasal challenge using 0.9% saline, was undertaken for exclusion of subjects hypersensitive to saline. The histamine nasal challenge could be initiated provided that NAR increase was <30%. Ranges of 0.4 to 3.2 mg.mL-1 histamine diluents were applied for a double-fold increment approach at intervals of 3 minutes.
16126208|NCT01963728|Drug|Insulin, Isophane|daily dosing based on fasting morning glucose levels
16126209|NCT01963728|Drug|insulin glargine|daily dose based on fasting morning glucose levels
16126210|NCT01963715|Drug|IMGN289|
16126211|NCT01963702|Drug|Docetaxol|
16126212|NCT01963702|Drug|Oxaliplatin|
16126213|NCT01963702|Drug|Capecitabine|
16126214|NCT01963689|Other|Intervention Group 2|Massage with Ylang Ylang Essence was applied for 30 seconds on the handle and the sternum area
16126215|NCT01963689|Other|Intervention Group 1|Massage with Ylang Ylang essential oil in the wrist and in the region of the sternum
16126216|NCT01963689|Other|Intervention Group 3|Put a drop of essential oil of ylang ylang in cotton located within the freshener and inhale throughout their work shift
16126217|NCT01963676|Device|tDCS|
16126218|NCT01963676|Device|Sham stimulation|
16126219|NCT01963663|Drug|Metformin|metformin 1000 mg daily in two divided doses of 500 mg tablets
16126220|NCT01963663|Drug|Pioglitazone|pioglitazone 30 mg daily in two divided doses of 15 mg tablets
16126221|NCT01963637|Device|gastric tomodensitometry with gas at 3 months and 12 months|
16126222|NCT01963624|Device|Ultrasonography|Comparison of B-mode US alone and combined use of elasto-doppler US along with B-mode US.
16126223|NCT01963611|Drug|Plovamer acetate 0.5 milligram (mg)|Plovamer acetate was administered at a dose of 0.5 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
16126224|NCT01963611|Drug|Copaxone 20 mg|Plovamer acetate was administered at a dose of 3 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
16126225|NCT01963611|Drug|Plovamer acetate 3 mg|Plovamer acetate was administered at a dose of 10 mg as weekly subcutaneous injection for 40 weeks up to a maximum of 14 months.
16126226|NCT01963611|Drug|Plovamer acetate 10 mg|Plovamer acetate was administered as two subcutaneous injection of 10 mg weekly for 40 weeks up to a maximum of 14 months.
16126227|NCT01963611|Drug|Plovamer acetate 20 mg|Copaxone was administered at a dose of 20 mg as subcutaneous injection once daily for 40 weeks up to a maximum of 14 months.
16126228|NCT01963598|Drug|REGN1033 (SAR391786)|
16126229|NCT01963598|Drug|placebo|
16126230|NCT01963572|Other|SG will be screened every time when they visit the clinics.|
16126231|NCT01963559|Drug|Lidocaine/prilocaine 1g (topical administration)|Cutaneous blood flow measurement using laser Doppler
16126232|NCT01963546|Other|different types of anesthesia|
16126233|NCT01963546|Drug|Dexmedetomidine|After selecting the appropriate anesthesia method, assess the effect of dexmedetomidine on controlling stress response from diabetics undergoing laparoscopic gastric-bypass surgical.The stress indicators are the same as described above.
16126234|NCT01963507|Behavioral|Resistance training|Resistance training performed three times at week for 16 weeks, in 8 exercises for the main muscles, the protocol of 3 sets of 10 repetitions with intensity of 50% of 1 maximum repetition (MR).
16126235|NCT01963494|Behavioral|Dyadic planning intervention|Dyadic planning refers to creating together with a partner if-then plans on when, where, and how the individual target person will implement a new behaviour.
16126240|NCT01963468|Behavioral|Early language intervention|Parents will practice the specific set of strategies (visual, interactive, tactile, responsive) during sessions that occur weekly and last 1 hour for a total of 26 sessions, over 6 months. Each session will include four segments: (a) the therapist will review the intervention strategies taught in the workshop (10 min), (b) the therapist will model the intervention strategy with the child (10 min), (c) the parent will practice the strategy with her child with coaching from the therapist across four different routines and activities of the parent's choice (30 min), and (d) the therapist will provide feedback to the parent, summarize the session, and answer the parent's questions (10 min).
16126241|NCT01963455|Biological|paraurethral injection of MDCs|MDCs transplantation by paraurethral injection .
16126242|NCT01963442|Radiation|Chest X-ray|at Day 0, Day 30 and relapse
16126243|NCT01963442|Biological|blood sampling /Cell Counts/ C reactive protein (CRP)/Biochemistry|
16126244|NCT01963442|Drug|Augmentin|2 tablets 3 times a day for 5 days from Day 3
16126245|NCT01963442|Drug|Placebo (for Augmentin)|2 tablets 3 times a day for 5 days from Day 3
16126246|NCT01963442|Drug|Beta-Lactams|administered from Day 0 to Day 3
16126247|NCT01963429|Procedure|radiofrequency ablation|"* RFA(radiofrequency ablation )
~RFA electrode: Cool-tip RF ablation system (Covidien plc, 20 Lower Hatch Street Dublin 2, Ireland) and Well-Point RF Electrode (STARmed, Koea)
~performed using either the manufacturer's standard algorithm or an interactive algorithm, with the latter being used when the impedance did not begin to increase at the midinterval of the standard algorithm
~the duration of a single RFA session was 10 min to 15 min."
16126248|NCT01963429|Radiation|Proton beam therapy|"* Proton
~66 GyE /10 fx, 6.6 GyE fraction dose, 5 days/week, for HCC free from the alimentary tract (i.e., stomach, duodenum, esophagus, small and large bowel) (more than 2cm from clinical target volume),TLV30<40%,and/orRLV30<30%)"
16126249|NCT01963416|Dietary Supplement|macro- and micro-nutrient matched control (240 ml)|
16126250|NCT01963416|Dietary Supplement|Orange juice|
16126251|NCT01963416|Dietary Supplement|whole orange fruit|
16126252|NCT01963416|Dietary Supplement|Processed whole orange|
16126253|NCT01963403|Drug|EE 30mcg/LNG 150mcg|1 pill per day; daily during study participation (up to 84 days)
16126254|NCT01963403|Drug|Placebo|1 pill per day; daily during study participation (up to 84 days)
16126255|NCT01963390|Drug|Testosterone Therapy|In this observational study we will be enrolling testosterone deficient men who intend to undergo testosterone therapy.
16126256|NCT01963377|Device|O2 through nasal cannulae|supplementation of O2 through nasal cannulae during bronchoscopy
16126257|NCT01963377|Device|O2-channel|supplementation of O2 through aspiration channel of bronchoscope during bronchoscopy
16126258|NCT01963364|Dietary Supplement|Inulin challenge|On two study days one week apart, fasted participants will consume 500ml of water, flavoured with lime juice, containing 40g inulin.
16126259|NCT01963364|Dietary Supplement|oligofructose supplement|Starting at the end of study day 1, consumption of 5 grams oligofructose coloured with carmine red food dye(<5%), dissolved in a hot drink, twice daily for 6 1/2 days/ 13 doses. The 14th dose of the week is the inulin challenge consumed as part of study day 1.
16126260|NCT01963338|Device|Intradermal injection in the forearm (0,1cc NaCl 0,9%)|This injection is conducted by the newly developed device.
16126261|NCT01963338|Device|Intradermal injection in the upper arm (0,1cc NaCl 0,9%)|This injection is conducted by the newly developed device in the upper arm (deltoid region).
16126262|NCT01963338|Drug|Intramuscular injection in the upper arm (0,5cc NaCl 0,9%)|This injection is conducted by needle and syringe in the upper arm (deltoid region).
16126263|NCT01963325|Drug|S-1 plus Abraxane|Patients will receive Abraxane at 100 mg/m2 X 3 doses on Days 1, 8. S-1 chemotherapy was given based on the body surface area, <1.25 m2: 80mg/day, 1.25~1.5 m2: 100mg/day, ≧1.5 m2: 120mg/day. Given orally twice daily for 14 days, followed by 7 days without treatment.
16126264|NCT01963312|Procedure|Transarterial Supraselective Embolization of the prostate|
16126265|NCT01963312|Procedure|Transurethral Resection of the prostate|
16126266|NCT01963299|Drug|5 ml Ropivacaine 10% + physiological saline|
16126267|NCT01963299|Drug|5 ml Ropivacaine 10% + Clonidine 1 µg/kg|
16126268|NCT01963286|Device|ICD with enhanced SVT discriminators|ICD will be programmed to uniform device settings with enhanced SVT discrimintators enabled.
16126269|NCT01963273|Procedure|Video Assisted Ablation of Pilonidal Sinus|
16126270|NCT01963260|Drug|MK-8723|MK-8723 administered as a single IV infusion over approximately 4 hours on Day 1.
16126271|NCT01963260|Drug|Matching Placebo|Matching placebo to MK-8723 administered as a single IV infusion over approximately 4 hours on Day 1.
16126272|NCT01963234|Behavioral|Seva|Patients were given access to use Seva. This is a mobile application that uses social and behavioral theories to help support people after alcohol use disorder recovery.
16126273|NCT01963221|Radiation|fludeoxyglucose(18f)|
16126274|NCT01963221|Other|blood sample|
16126275|NCT01963221|Other|cardiac and aortic magnetic resonance imaging|
16126276|NCT01963221|Other|carotid femoral pulse wave velocity|
16126277|NCT01963221|Radiation|positron emission tomography|
16126278|NCT01963221|Radiation|computed tomography|
16126279|NCT01963208|Drug|ganaxolone|200 mg and 225 mg capsules; target dose 1800 mg/day dosed 900mg 2x/day
16126280|NCT01963208|Drug|Placebo|placebo
16126281|NCT01963195|Drug|Icotinib|Patients can accept the treatment with Icotinib (250/375/500mg tid) until disease progression or unacceptable toxicities occurred. The overall study period takes about 24 months
16126282|NCT01963182|Drug|Irinotecan|
16126283|NCT01963169|Behavioral|TO-BoneHealth Program (Bone Power Program)|The 8-week TO-BoneHealth program include: (1) web learning modules, (2) moderated discussion boards, (3) an Ask-the-Experts section, and (4) a virtual library. In addition, a tool kit and video lecture library are also available to participants. The program will be closed after 8 weeks, and there will be no eNewsletter or bi-weekly follow-ups of bone health behavior goal attainment. After 8 weeks, participants will receive a monthly e-mail informing them of the upcoming surveys.
16126284|NCT01963169|Behavioral|TO-BoneHealth Plus Program (Bone Power Plus Program)|This intervention includes the 8-week TO-BoneHealth program followed by bi-weekly theory-based eNewsletters with follow-up of each individual's maintenance of bone health behaviors for 10 months.
16126285|NCT01963156|Behavioral|Prescription synchronization|"Each patient's medication that has the greatest quantity of pills on hand after randomization will be defined as the index medication and partial supplies will be provided for all other eligible medications in order to synchronize all of a patient's medication. Prescribers will be contacted for a new prescription to ensure all eligible medications are on the same renewal schedule.
~Randomization will occur within strata of whether patients are enrolled in the ReadyFill@Mail program. Once synchronized, patients who are not enrolled in the ReadyFill@Mail program will initiate their own refills. Patients who are enrolled in the ReadyFill@Mail program will have their refills automatically filled, however patients may disenroll from ReadyFill@Mail at any time, in which case they will initiate their own refills. Patients may disenroll in whole or in part from the program at any point."
16126286|NCT01963143|Biological|Gammaplex (5%)|
16126287|NCT01963143|Biological|Gammaplex 10|
16126288|NCT01963117|Radiation|Combined hyperthermia and radiation therapy|
16126289|NCT01963104|Procedure|Automated hearing test|Subjects will take an automated hearing test that presents tones at different pitches and volumes. Participants will identify whether or not they heard the tone and receive printed recommendations for hearing healthcare follow-up. All subjects will complete the Hearing Handicap Inventory (HHI) questionnaire and the Hearing Beliefs Questionnaire (HBQ). Approximately 6-8 months after their initial appointment, subjects in this groups will receive a telephone call and will be asked questions related to their actions and attitudes related to hearing and hearing health care.
16126290|NCT01963104|Procedure|Pure-tone Screener test|During the test different tones are going to be presented at one volume level. Participants will identify whether or not they heard the tone and receive printed recommendations for hearing healthcare follow-up. All subjects will complete the Hearing Handicap Inventory (HHI) questionnaire and the Hearing Beliefs Questionnaire (HBQ). Approximately 6-8 months after their initial appointment, subjects in this groups will receive a telephone call and will be asked questions related to their actions and attitudes related to hearing and hearing health care.
16126291|NCT01963104|Procedure|Digits-in-noise test|During the test subjects will hear a pattern of 3 numbers with variable noise in the background and identify the pattern they hear, and receive printed recommendations for hearing healthcare follow-up. All subjects will complete the Hearing Handicap Inventory (HHI) questionnaire and the Hearing Beliefs Questionnaire (HBQ). Approximately 6-8 months after their initial appointment, subjects in this groups will receive a telephone call and will be asked questions related to their actions and attitudes related to hearing and hearing health care.
16126292|NCT01963104|Procedure|No screening test|This group of subjects will not receive a screening test. All subjects will complete the Hearing Handicap Inventory (HHI) questionnaire and the Hearing Beliefs Questionnaire (HBQ). Approximately 6-8 months after their initial appointment, subjects in this group will receive a telephone call and will be asked questions related to their actions and attitudes related to hearing and hearing health care.
16126293|NCT01963104|Procedure|Automated hearing test/Motivation video|Subjects will take an automated hearing test that presents tones at different pitches and volumes.Participants will identify whether or not they heard the tone and receive printed recommendations for hearing healthcare follow-up. They will also watch a brief video that shows how hearing works and learn about the different types of hearing loss. All subjects will complete the Hearing Handicap Inventory (HHI) questionnaire and the Hearing Beliefs Questionnaire (HBQ). Approximately 6-8 months after their initial appointment, subjects in this groups will receive a telephone call and will be asked questions related to their actions and attitudes related to hearing and hearing health care.
16126294|NCT01963104|Procedure|Pure-tone Screener/Motivation video|During the test different tones are going to be presented at one volume level. Participants will identify whether or not they heard the tone and receive printed recommendations for hearing healthcare follow-up. They will also watch a brief video that shows how hearing works and learn about the different types of hearing loss. All subjects will complete the Hearing Handicap Inventory (HHI) questionnaire and the Hearing Beliefs Questionnaire (HBQ). Approximately 6-8 months after their initial appointment, subjects in this group will receive a telephone call and will be asked questions related to their actions and attitudes related to hearing and hearing health care.
16126295|NCT01963104|Procedure|Digits-in-noise test/Motivational video|During the test subjects will hear a pattern of 3 numbers with variable noise in the background and identify the pattern they hear, and receive printed recommendations for hearing healthcare follow-up. They will also watch a brief video that shows how hearing works and learn about the different types of hearing loss. All subjects will complete the Hearing Handicap Inventory (HHI) questionnaire and the Hearing Beliefs Questionnaire (HBQ). Approximately 6-8 months after their initial appointment, subjects in this group will receive a telephone call and will be asked questions related to their actions and attitudes related to hearing and hearing health care.
16126296|NCT01963104|Procedure|No screening test/Motivational video|This group of subjects will not receive a screening test. They will watch a brief video that shows how hearing works and learn about the different types of hearing loss. All subjects will complete the Hearing Handicap Inventory (HHI) questionnaire and the Hearing Beliefs Questionnaire (HBQ). Approximately 6-8 months after their initial appointment, subjects in this group will receive a telephone call and will be asked questions related to their actions and attitudes related to hearing and hearing health care.
16126297|NCT01963104|Procedure|Home Hearing Screening Test|Subjects will be taught the set-up for a home hearing screening test and will take an automated hearing test that presents tones at different pitches and volumes. Participants will identify whether or not they heard the tone and receive printed recommendations for hearing healthcare follow-up. All subjects will complete the Hearing Handicap Inventory (HHI) questionnaire and the Hearing Beliefs Questionnaire (HBQ). Approximately 6-8 months after their initial appointment, subjects in this groups will receive a telephone call and will be asked questions related to their actions and attitudes related to hearing and hearing health care.
16126370|NCT01962532|Drug|Part 1: JNJ-42756493|JNJ-42756493 dose escalation starting at dose of 2 mg orally daily for 21-day cycles and 28 day cycles Intermitting dosing regimen (7 days on and 7 days off) up to the maximum tolerated dose in order to determine the recommended Phase 2 dose.
16126371|NCT01962532|Drug|Part 2: JNJ-42756493|Recommended Phase 2 JNJ-42756493 dose determined in Part 1 administered orally for 28-days cycles (Intermitting dosing regimen).
16126372|NCT01962519|Dietary Supplement|Early oral feeding|Oral fluids starting on POD 1, followed by a soft diet (thin purée six times a day) on day 2, and regular solid diet thereafter
16126298|NCT01963104|Procedure|Home Hearing Screening Test/Brief video|"Subjects will be taught the set-up for a home hearing screening test and will take an automated hearing test that presents tones at different pitches and volumes. Participants will identify whether or not they heard the tone and receive printed recommendations for hearing healthcare follow-up. All subjects will complete the Hearing Handicap Inventory (HHI) questionnaire and the Hearing Beliefs Questionnaire (HBQ). They will also watch a brief video that shows how hearing works and learn about the different types of hearing loss.
~Approximately 6-8 months after their initial appointment, subjects in this groups will receive a telephone call and will be asked questions related to their actions and attitudes related to hearing and hearing health care."
16126299|NCT01963091|Drug|oxytocin|Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
16126300|NCT01963091|Drug|saline|Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo at 1:15pm. This dose and timing of administration was selected based on previous studies that have used similar doses of oxytocin (Ditzen, et al., 2009; Heinrichs, et al., 2003). Intranasal oxytocin and matching placebo will be compounded by Pitt Street Pharmacy Custom Compounding (Mt. Pleasant, South Carolina). Randomization will be done by a licensed pharmacist who will keep a record of the blind and be available should unblinding be necessary.
16126301|NCT01963078|Drug|Oxytocin|
16126302|NCT01963078|Drug|Placebo|
16126303|NCT01963052|Drug|AGS15E|intravenous (IV) infusion
16126304|NCT01963039|Device|percutaneous vertebroplasty|Using fluoroscopic guidance, the practitioner infiltrates the skin and subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae with 1% lidocaine and infiltrates the periosteum of the pedicles with 0.25% bupivacaine (marcaine. For the vertebroplasty procedure, 11-gauge or 13-gauge needles are passed into the central aspect of the target vertebra or vertebrae. Bone cement is prepared on the bench and injected under constant fluoroscopy into the vertebral body. Injection is stopped when the PMMA reaches the posterior aspect of the vertebral body or leaks into an extraosseous space, such as the intervertebral disk or an epidural or paravertebral vein.
16126305|NCT01963039|Procedure|Sham procedure|Using fluoroscopic guidance, the practitioner infiltrates the skin and subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae with 1% lidocaine and infiltrates the periosteum of the pedicles with 0.25% bupivacaine (marcaine). During the sham intervention, verbal and physical cues, such as pressure on the patient's back, are given, and the methacrylate monomer (PMMA) is opened to simulate the odor associated with mixing of cement, but the needle is not placed and cement is not injected.
16126306|NCT01963026|Other|ToCUEST featuring a 'variable practice' approach.|Intervention Variable practice: The ToCUEST (Task-Oriented Client-centred Upper Extremity Skill Training) module [17] will be given to the participants, in which individual goals will be extracted using the COPM (Canadian Occupational Performance Measure). The training program will start with a task analysis and is based on principles of training physiology and motor learning, including variability practice, random practice, distribution based practice, feedback, whole learning. A detailed description of the ToCUEST module is given in Spooren et al. [17]. Intervention B will be called 'ToCUEST variability' in the present project.
16126307|NCT01963026|Other|ToCUEST featuring a 'constant practice' approach.|Intervention Constant practice: In order to evaluate the contribution of the component 'variability practice' in contrast with 'constant practice' the participants will be offered the modified ToCUEST ('ToCUEST constant') module in which the component 'variability practice' is replaced by 'constant practice'.
16126308|NCT01963013|Device|Non-returning catheter valve|
16126309|NCT01963013|Device|Conventional urine bag|
16126310|NCT01962987|Drug|Diclofenac sodium|Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
16126311|NCT01962987|Other|Placebo|Topical administration of approximately 0.5g twice daily to the 25 sq cm treatment area for 60 days.
16126312|NCT01962974|Biological|Golimumab 2 mg/kg IV|Study drug (golimumab 2 mg/kg IV) will be administered as an intravenous (IV) infusion at Weeks 0, 4, 12, 20 and 28.
16126313|NCT01962961|Dietary Supplement|PharmaNAC (N-acetylcysteine)|"PharmaNAC is considered a nutritional supplement and can be obtained without a prescription. All participants will be asked to ingest two tablets twice per day during this trial. For those randomized to PharmaNAC 1800 mg twice daily, this will be two active tablets twice per day. For those randomized to PharmaNAC 900 mg twice daily, this will be one active tablet twice per day and one matching placebo tablet twice per day. For those randomized to placebo, this will be two matching placebo tablets twice per day.
~PharmaNAC can be taken with or without food. The effervescent tablets should be dissolved in 8 oz. of water or juice prior to oral intake. Each participant will take study drug and/or matching placebo for 8 weeks (up to 60 days)."
16126314|NCT01962961|Dietary Supplement|Matching placebo|Inactive pill that matches PharmaNAC on taste, color, and appearance.
16126315|NCT01962948|Drug|paclitaxel|Given IV
16126316|NCT01962948|Drug|ganetespib|Given IV
16126317|NCT01962948|Other|laboratory biomarker analysis|Correlative studies
16126318|NCT01962935|Drug|AZD4721|Part A - multiple ascending dose, daily; Part B - one dose decided after part A, daily
16126319|NCT01962935|Drug|Placebo|Part A - multiple ascending dose daily
16126320|NCT01962935|Drug|AZD5069|Part B - one dose decided after part A, twice a day
16126321|NCT01962922|Drug|LCP-Tacro|once-daily extended release tablet
16126322|NCT01962922|Drug|Tacrolimus -IR|twice daily capsules
16126323|NCT01962909|Drug|PTP-01|Dose level 1 is 10mCi (50ug of peptide)
16126324|NCT01962896|Drug|Erlotinib|
16126325|NCT01962896|Drug|Sirolimus|
16126373|NCT01962493|Other|Sodium bicarbonate/ Sodium Fluoride|Toothpaste containing sodium bicarbonate and sodium fluoride as cosmetic
16126374|NCT01962493|Other|Sodium fluoride|Toothpaste containing sodium fluoride as cosmetic
16126375|NCT01962493|Drug|Chlorhexidine digluconate|Mouthwash containing chlorhexidine digluconate
16126508|NCT01961479|Behavioral|Internet-based CBT for patients with PMS|Internet-based cognitive-behavioural self-help treatment
16126764|NCT01959490|Drug|paclitaxel|Given IV
16126326|NCT01962883|Other|Osteopathic treatment|"The following treatment protocol is an outline only; structures will be treated only if the dysfunction was present during the evaluation.
~Week 1: Venous Sinuses, diaphragms, major cranial compactions, sphenobasilar symphysis normalization and dural release
~Week 2 Non-Physiological without respect of axis dysfunction in cranium, spine, pelvis, ankle. Non-physiological with respect of axis dysfunctions in the cranium. Temporal and orbital sutures.
~Week 3 Non-Physiological with respect of axis dysfunction lesions within the spine, pelvis and ankle. Visceral tissues: kidneys, liver, spleen, heart. Cerebral hemisphere and lateral ventricles.
~Week 4 Physiological dysfunctions within the cranium, spine, pelvis, and ankle. Myofascial restrictions and muscles of the jaw and eye."
16126327|NCT01962870|Drug|Vasopressin|Participants aged 6 to 9.5 years of age will receive the maximum dose of 24 IU (12 IU twice daily). Participants aged 9.6 to 12 years of age will receive the maximum dose of 32 IU (16 IU twice daily).
16126328|NCT01962870|Drug|Placebo|
16126329|NCT01962857|Behavioral|Exercise|4-week supervised high intensity shuttle running intervention, 3 sessions per week (12 sessions in total)
16126330|NCT01962844|Dietary Supplement|Coconut Oil|Patients were followed for 6 months with dietary treatment. Beginning supplementation with coconut oil extra virgin from the third month of intervention nutrition. Coconut oil was consumed neat or added to fruit.
16126331|NCT01962844|Behavioral|Diet|Patients were instructed to follow the dietary treatment for 6 months
16126332|NCT01962831|Drug|Dinoprostone|
16126333|NCT01962831|Device|Single balloon foley catheter|
16126334|NCT01962818|Other|HFOV combined with sigh breaths|"It is planned only to investigate infants already ventilated on the HFOV-modus on high frequency oscillators, where the HFOV modus can be superimposed on conventional modes of ventilation. This gives the opportunity to combine HFOV with intermittent sigh breaths with a pre-set frequency and pre-set peak inspiratory pressure (PIP) and thus comparing HFOV combined with sigh breaths (HFOV-sigh) with conventional HFOV (HFOV-only).
~All included participants will be exposed to the two different ventilator strategies tested in this trial, albeit in alternating and different order.
~Each patient will serve, as it's own control. The trial will involve four alternating 1-hours periods allowing a sufficient wash-out period, as it has been shown that alveolar recruitment and derecruitment may take up to 25 min after changes to ventilator pressures At study start the patients will randomly be assigned to either starting with HFOV-only or HFOV-sigh"
16126335|NCT01962805|Drug|Proellex Formulation A|
16126336|NCT01962805|Drug|Proellex Formulation B|
16126337|NCT01962792|Drug|Ibrutinib|
16126338|NCT01962792|Drug|Carfilzomib|
16126339|NCT01962792|Drug|Dexamethasone|
16126340|NCT01962779|Other|Continuous positive airway pressure (CPAP)|Continuous positive airway pressure (CPAP). CPAP typically is used for people who have breathing problems, such as sleep apnea.
16126341|NCT01962766|Behavioral|Myofunctionnal therapy|
16126342|NCT01962766|Behavioral|instructions|
16126343|NCT01962753|Drug|18FAV45|Admnistration of 18FAV45 if patient is compliant with one of those treatment: Seroplex, Zoloft, Deroxat, Venlafaxine, Mirtazapine, Moclamine,
16126344|NCT01962740|Device|Drug-eluting stent implantation|
16126345|NCT01962714|Behavioral|Loving-Kindness Meditation|12-week loving-kindness meditation course
16126346|NCT01962714|Behavioral|Cognitive Processing Therapy|12-week CPT course
16126347|NCT01962688|Device|Handheld ultrasound|Handheld ultrasound determination of IVC diameter
16126348|NCT01962688|Device|Sham ultrasound|sham ultrasound to facilitate blinding
16126349|NCT01962675|Device|Transcranial direct current stimulation + step training|Direct current stimulation of motor cortex with low stimulation intensity
16126350|NCT01962675|Behavioral|Sham transcranial direct current stimulation + step training|Stepping over specified soft foam obstacles
16126351|NCT01962662|Other|EMG biofeedback training|EMG biofeedback assisted tibialis anterial force level control
16126352|NCT01962662|Other|U/E exercise|strengthening and stretching
16126353|NCT01962649|Biological|ICG|
16126354|NCT01962649|Device|Optical molecular imaging|
16126361|NCT01962623|Other|IPT-MBD|IPT-MBD is a modified form of Interpersonal Psychotherapy for Depressed Adolescents (IPT-A), which emphasizes building skills in managing relationships, helping with problem solving, and strengthening communication skills.
16126362|NCT01962610|Other|ePCA and Pain keycept intervention|Study designed ePCA and pain keycept interventions are embedded in electronic medical record during patient ED visit.
16126363|NCT01962597|Other|aerobic exercise|
16126364|NCT01962597|Other|resistance training|
16126365|NCT01962571|Drug|Erythropoietin alfa|
16126366|NCT01962571|Drug|Placebo|
16126367|NCT01962558|Device|VNS Treatment|VNS is given in brief bursts over a 2.5 hour period. The subject also has headphone connected to a computer, and hears audio tones through the headphones that occur during VNS.
16126368|NCT01962558|Device|VNS Control|This is the sham-control group; subjects in this group will receive both tones and VNS, but in a manner that is expected to be ineffective.
16126369|NCT01962545|Drug|OAC alone|Single APT with either aspirin or clopidogrel is discontinued in this arm.
16126376|NCT01962480|Procedure|The hernia gap is sutured intracorporally|The hernia gab is closed with non-absorbable suture (Ethibond Excel 2-0, Ethicon, Johnson & Johnson©) performed by an intracorporally interrupted sutured technique using an Auto Suture© Endo-Slide knot-tying instrument. The stitches are placed with a distance of 0.5 - 1 cm from the fascial edges and with a distance of 0.5-1 cm. between the stitches, performed under a 6-8 mmHg intrabdominal pressure.
16126377|NCT01962467|Drug|FF/LEV FDC|Intranasal aqueous microsuspension containing 25.0 microgram (µg) of FF and 50 µg of LEV as a fixed dose combination. It will be administered as two 50 µL sprays per nostril in the morning in a fasted state
16126378|NCT01962467|Drug|FF|Intranasal aqueous microsuspension containing 27.5µg of FF. It will be administered as two 50 µL sprays per nostril in the morning in a fasted state
16126379|NCT01962467|Drug|LEV|Intranasal aqueous microsuspension containing 50 µg of LEV. It will be administered as two 50 µL sprays per nostril in the morning in a fasted state
16126380|NCT01962454|Drug|Deuterated Water|D2O 70% will be supplied as clear liquid, provided in 50 millilitre (mL) unit dose vials; administered per orally.
16126381|NCT01962454|Drug|Testosterone enanthate|Testosterone enanthate 125mg injection will be supplied as colorless to pale yellow liquid; administered intramuscular (IM).
16126382|NCT01962454|Drug|Placebo to match testosterone enanthate|Placebo to match testosterone enanthate 0.625 mL injection will be supplied as greenish yellow, bright and clear oily liquid; administered intramuscular (IM).
16126383|NCT01962441|Drug|SOF|400 mg tablet administered orally once daily
16126384|NCT01962441|Drug|RBV|Tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16126385|NCT01962441|Drug|Peg-IFN|180 µg administered via subcutaneous injection once weekly
16126386|NCT01962428|Drug|ticagrelor|Patients will receive ticagrelor 360mg loading dose or 180mg loading dose , then 90mg bid maintenance dose starting 12 hours after loading dose.
16126387|NCT01962415|Drug|Hydroxyurea|Oral administration at 30 mg/kg/day.
16126388|NCT01962415|Drug|Alemtuzumab|"Intravenous (IV) administration. The first dose for each arm will be a test dose (0.2 mg/kg max 5 mg). The treatment doses of alemtuzumab will be based on the patients' assigned stratum as determined by their age, lymphocyte count and presence of infection.
~Stratum 1: 1 mg/kg (max dose of 30 mg); Stratum 2: 0.5 mg/kg (max dose of 30 mg); Stratum 3: No treatment dose, test dose only."
16126389|NCT01962415|Drug|Fludarabine|IV administration at 30 mg/m2/day or 1 mg/kg/dose, whichever is lower.
16126390|NCT01962415|Drug|Melphalan|IV administration at 70 mg/m2/dose.
16126391|NCT01962415|Drug|Thiotepa|IV administration at 200 mg/m2/dose
16126392|NCT01962402|Drug|lorcaserin|Patients will receive lorcaserin 10mg tablet, 1 tablet twice daily for 12 weeks.
16126393|NCT01962402|Behavioral|Intensive dietary counseling|All patients in the study will receive intensive dietary counseling, encouraging eating minimal carbohydrates and sugars.
16126394|NCT01962389|Device|Winsor Laser Catheter|
16126395|NCT01962376|Drug|Oxaliplatin;Capecitabine|A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk.Evaluation for every two cycles.
16126396|NCT01962376|Drug|Oxaliplatin;Capecitabine;Bevacizumab|A cycle:Capecitabine 2000mg/m2 D1-D14 q3wk、Oxaliplatin 130 mg/m2 D1 q3wk add and subtract. Bevacizumab 7.5mg/kg D1 q3wk.Evaluation for every two cycles.
16126397|NCT01962363|Drug|EPI-743|EPI-743 (alpha-tocotrienol quinone) is a small molecule therapeutic that was rationally designed to replete reduced glutathione through NQO1-catalyzed electron transfer from NADPH.
16126398|NCT01962350|Device|Deep Brain Transcranial Magnetic Stimulation|H1-Coil deep brain rTMS at cortex prefrontal.
16126399|NCT01962337|Drug|FPA008|Infusion
16126400|NCT01962337|Drug|Placebo|Infusion
16126401|NCT01962324|Radiation|SIB Dose-Escalation Radiotherapy|
16126402|NCT01962311|Procedure|lumbar puncture|lumbar puncture at enrollment in study
16126403|NCT01962298|Drug|sugammadex 2mg/kg|
16126404|NCT01962298|Drug|neostigmine|
16126405|NCT01962298|Drug|sugammadex 4mg/kg|
16126406|NCT01962298|Drug|placebo|
16126407|NCT01962298|Drug|Single rocuronium dose|
16126408|NCT01962298|Drug|Repeated rocuronium dose|
16126409|NCT01962298|Drug|Continuous rocuronium infusion|
16126410|NCT01962285|Drug|propofol targel controlled infusion|slow stepped propofol target controlled infusion using Schinider´s pharmacokinetic parameters seriated venous blood sampling
16126411|NCT01962272|Behavioral|Weekly nutritional counseling|The counseling included assessment of food intake, advice about improvement, motivation and specific food plans, as well as motivation to comply to the recommended dose of Forticare®.
16126412|NCT01962272|Dietary Supplement|Forticare®.|
16126413|NCT01962259|Behavioral|Physical activity|
16126414|NCT01962246|Drug|Oxaliplatin; Capecitabine|Capecitabine 2000mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for eight cycles postoperation
16126415|NCT01962246|Other|Oxaliplatin; Capecitabine; concurrent radiotherapy|Capecitabine 2000mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for two cycles preoperation , Capecitabine 2000mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for six cycles postoperation Radiation: radiotherapy 50 Gy in 25 fractions (2Gy /day, 5 days/week,Monday through Friday, ) Other Name: XRT
16126416|NCT01962233|Biological|mesenchymal stem cells|"Procedure: On the basis of conventional therapy, at the same time, selected patients were given by intravenous infusion of umbilical cord blood stem cells 100-800 million. All patients before treatment, after treatment for 15days, 90days and 180 days were evaluated respectively the curative effect.
~Intravenous infusion of umbilical cord derived mesenchymal stem cells"
16126417|NCT01962220|Behavioral|Study Intervention for Retention (APFU)|"Each newly identified HIV-infected pregnant woman randomized to the experimental arm will be assigned an outreach worker/counselor (Mama Mshauri).
~Mama Mshauri tasks will include:
~Immediately engaging the newly identified pregnant woman, providing individualized adherence and disclosure support, management of ART side effects, and helping the client navigate the health system.
~Providing tailored individualized health education during home visits.
~Additional intervention components include:
~Appointments and Reminders: SMS or telephone reminders 1 week and 3 days before appointments. Reinforcement of importance of follow-up during home visits and every contact.
~Patient Tracking and Defaulter Tracing: Monthly visits and immediate calls/home visit if she misses an appointment."
16126419|NCT01962194|Device|Deep Brain Stimulation|"In this study we will use implantable Deep Brain Stimulation (DBS) system with local field potential sensing capability. The Device is the Medtronic, Inc DBS Implantable System, Activa PC+S, which has therapy equivalent to Activa PC, and has a new sensing programmer."
16126420|NCT01962181|Drug|Ritalin|Patients with ADHD and healthy subjects will be examined under Ritalin or placebo
16126421|NCT01962181|Drug|Placebo|
16126422|NCT01962168|Device|Evolution® Biliary Stent - Uncovered|Commercially available device
16126423|NCT01962142|Other|Assessment of activity capacities|
16126424|NCT01962129|Biological|Sampling of blood|
16126425|NCT01962116|Drug|Citrate 4%|
16126426|NCT01962116|Drug|unfractionated heparin|
16126427|NCT01962103|Drug|nab-paclitaxel|nab-paclitaxel 120-270 mg/m2 IV on Days 1, 8 and 15 of a 28-day cycle
16126428|NCT01962103|Drug|nab-paclitaxel|IV infusion
16126429|NCT01962090|Other|Thoracic Spine Thrust in Seated Position|The thoracic spine manipulation used here is a manipulation technique that involves positioning the patient so that a small amplitude quick stretch can be applied to the least mobile area of the thoracic spine as identified by the licensed physical therapist during spinal segmental mobility testing.
16126430|NCT01962090|Other|Thoracic Spine Thrust in Supine Position|The thoracic spine manipulation used here is a manipulation technique that involves positioning the patient so that a small amplitude quick stretch can be applied to the least mobile area of the thoracic spine as identified by the licensed physical therapist during spinal segmental mobility testing.
16126431|NCT01962077|Procedure|MedCem MTA pulpotomies in primary teeth.|
16126432|NCT01962064|Behavioral|Cognitive assessment|
16126433|NCT01962064|Other|Brain imaging examination MRI|
16126434|NCT01962051|Device|Amplatzer Cardiac Plug|
16126435|NCT01962038|Behavioral|Combined Aerobic and Resistance Exercise|Gym and home based aerobic and resistance exercises
16126436|NCT01962038|Behavioral|Stretching Exercises|Gym and home based stretching exercises
16126437|NCT01962038|Behavioral|Cognitive Training|Group-based cognitive training
16126438|NCT01962025|Procedure|Buttonhole needling technique|the intervention is the type of needling used for home hemodialysis patients. They will be randomized to either buttonhole cannulation or stepladder cannulation
16126439|NCT01962012|Device|AcceleDent Aura|
16126440|NCT01962012|Device|Sham Device|
16126441|NCT01961999|Procedure|Early RRT|"In the early arm renal replacement therapy was started on the basis of refractory oliguria: urine output <0,5ml/Kg/h for > 6 hours"
16126442|NCT01961999|Procedure|Late RRT|"In the late arm at least one the following criteria must be fulfilled prior to initiation of renal replacement therapy:
~persistent and refractory oliguria (<0,5ml/Kg/h >12h), despite therapy refractory extravascular fluid overload azotemia >40mmol/L or 240mg/dL metabolic acidosis (pH<7,2) hyperkaliemia (k+>6mmol/L)"
16126443|NCT01961986|Procedure|TSR - traditional subscapularis release|Total Shoulder Replacement surgery performed using the traditional subscapularis release approach.
16126444|NCT01961986|Procedure|TSR - rotator cuff sparing|Total Shoulder Replacement surgery performed using the rotator cuff sparing approach.
16126445|NCT01961973|Procedure|Cultured Chondrocytes|This method has two stages. In the first stage, a knee arthroscopy is done to harvest viable cartilage cells which are then sent to a lab to be cultured for 6 weeks. In the second stage, an arthrotomy is performed. The area of cartilage deficiency is prepared and the cultured cells are transplanted onto it. After discharge from the hospital, the patient is advised partial weight bearing on the operated leg for 6 weeks after the surgery.
16126446|NCT01961973|Procedure|Cultured BMAC|This method also has two major stages. The first stage involves harvesting BMAC from the patient's iliac crest (hip bone), which are then sent to the laboratory for culture for 3 weeks. Simultaneously, an arthroscopy is performed on the affected knee and the area of cartilage deficiency is debrided and microfractured. In the second stage, the cultured BMAC are injected into the affected knee and cells attach themselves to the microfractured area. The patient is then recalled at 4, 5 and 6 weeks from the first stage for an injection of Hyaluronic Acid into the operated knee.
16126447|NCT01961960|Biological|ASP7374|intramuscular
16126448|NCT01961947|Biological|ASP7374|subcutaneous
16126449|NCT01961947|Biological|approved egg-derived TIV|subcutaneous
16126450|NCT01961934|Drug|Sodium Acetate C11 PET/CT Imaging|
16126451|NCT01961921|Drug|ALN-TTR02 (patisiran) administered by intravenous (IV) infusion|
16126452|NCT01961908|Drug|Proellex|
16126453|NCT01961895|Procedure|Continuous lumbar plexus (LP) block analgesia|
16126454|NCT01961895|Drug|Intravenous patient-controlled analgesia|
16126455|NCT01961882|Drug|OCV-501|
16126456|NCT01961882|Drug|Placebo|
16126457|NCT01961869|Other|Fast release BRB confection|Fast release BRB confection includes lyophilized black raspberry powder, corn syrup, and sugar. All ingredients are generally regarded as safe (GRAS) food ingredients
16126458|NCT01961869|Other|Intermed release BRB confection|Intermediate release BRB confection includes lyophilized black raspberry powder, corn syrup, sugar, and pectin. All ingredients are generally regarded as safe (GRAS) food ingredients
16126459|NCT01961869|Other|Prolong release BRB confection|Prolonged release BRB confection includes lyophilized black raspberry powder, corn syrup, corn starch, and sugar. All ingredients are generally regarded as safe (GRAS) food ingredients.
16126460|NCT01961856|Drug|Clopidogrel and Ticagrelor|Clopidogrel 600mg loading dose followed by Ticagrelor 180mg loading dose
16126461|NCT01961856|Drug|Ticagrelor|Ticagrelor 180mg loading dose
16126462|NCT01961843|Drug|Abiraterone|Abiraterone acetate is an orally bioavailable inhibitor of steroid synthesis, specifically testosterone synthesis.
16126463|NCT01961843|Drug|Prednisone|Prednisone is a synthetic corticosteroid that is co-administered with abiraterone acetate to offset the hypokalemia and hypertension side effects of abiraterone acetate.
16126464|NCT01961830|Drug|ME1100 inhalation solution|
16126465|NCT01961817|Other|Retromolar Vocal Cord Visualisation|For easier insertion of the laryngoscope the head of the patient will be turned to the left site. Thereafter the blade (Miller) will be inserted into the mouth and pushed carefully as far as possible laterally to receive a direct view of the vocal cords. Then the performing anesthesiologist determine the Cormack & Lehane score without and thereafter with a BURP (backward upward rightward pressure) maneuver.
16126765|NCT01959490|Drug|Bevacizumab|
16126466|NCT01961817|Other|Conventional Vocal Cord Visualisation|The head of the patient will be positioned as usual. After 2 minutes oxygen insufflation the laryngoscope will be inserted laterally to push the tongue to the left side in order to release the sight to the vocal cords. Thereafter the anesthesiologist determines the Cormack & Lehane score without and thereafter with performance of the BURP (backward upward rightward pressure) maneuver.
16126467|NCT01961804|Drug|Reversion|Administration of prothrombin complex concentrates: KANOKAD before CT Scan
16126468|NCT01961791|Procedure|gastrectomy|gastrectomy with D1 + lymph node dissection for clinically early gastric cancer, and gastrectomy with D2 lymph node dissection for clinically advanced gastric cancer
16126469|NCT01961778|Device|Radio-Frequency Ablation|
16126470|NCT01961778|Device|Cryotherapy|
16126471|NCT01961765|Drug|cabozantinib|
16126472|NCT01961752|Drug|Saline|All patients undergo endoscopic submucosal dissection. The local injection was performed using 15 ml saline just before the ESD was finished. It was delivered through the endoscopy suite and injected into the cautery ulcer base in aliquots of 1 mL at equal intervals (1 cm apart). The number of injections per patient was dependent on the size of resection.
16126473|NCT01961752|Drug|Bupivacaine + saline|All patients undergo endoscopic submucosal dissection. The local injection was performed using a mixture of 10 ml bupivacaine (total 50 mg) and 5 ml saline just before the ESD was finished. It was delivered through the endoscopy suite and injected into the cautery ulcer base in aliquots of 1 mL at equal intervals (1 cm apart). The number of injections per patient was dependent on the size of resection.
16126474|NCT01961752|Drug|Bupivacaine + triamcinolone acetonide|All patients undergo endoscopic submucosal dissection. The local injection was performed using a mixture of 10ml bupivacaine (total 50 mg) and 5 ml triamcinolone acetonide (total 50 mg) just before the ESD was finished. It was delivered through the endoscopy suite and injected into the cautery ulcer base in aliquots of 1 mL at equal intervals (1 cm apart). The number of injections per patient was dependent on the size of resection.
16126475|NCT01961739|Drug|2% lidocaine|Topical application, twice per day for 15 consecutive days
16126476|NCT01961739|Drug|placebo|topical application, twice per day for 15 consecutive days
16126477|NCT01961726|Biological|Placebo|Coronary Sinus Delivery
16126478|NCT01961726|Biological|30 mg dose of JVS-100|Coronary Sinus Delivery
16126479|NCT01961726|Biological|45 mg dose of JVS-100|Coronary Sinus Delivery
16126480|NCT01961700|Other|Physiotherapy|Physiotherapy treatment
16126481|NCT01961687|Device|Resorbable Mesh|Phasix Mesh
16126482|NCT01961674|Dietary Supplement|Capsinoid/placebo and rice|The subject will ingest six capsinoid/placebo capsules and a standardized amount of white rice (equivalent to 50g carbohydrates). Each capsule consists 1.5mg of capsinoids, making a total dose of 9mg capsinoids.
16126483|NCT01961661|Dietary Supplement|Lactobacillus rhamnosus GG|"Capsules containing lyophilized 6x10^9 Colony Forming Units (CFU)/die LGG, (60mg) maltodextrin (163 mg), gelatine capsule (75 mg), magnesium stearate (2 mg)
~1 capsule/die for 1 month"
16126484|NCT01961661|Dietary Supplement|placebo|"Capsules containing maltodextrin (163 mg), gelatine capsule (75 mg), magnesium stearate (2 mg)
~1 cps/die for 12 months"
16126485|NCT01961648|Device|Rebreathing bag|
16126486|NCT01961648|Device|Sham rebreathing|
16126487|NCT01961648|Device|Mask|
16126488|NCT01961635|Device|dental implants|place implant according fabricant guidelines, 2mm sub-crestally
16126489|NCT01961635|Device|Zirconia abutments|place zirconia abutment on the day of implant placement
16126490|NCT01961635|Device|Titanium Abutments|place titanium abutment on the day of implant placement
16126491|NCT01961635|Device|cad-cam acrylic abutments|place cad-cam acrylic abutment on the day of implant placement
16126492|NCT01961635|Procedure|Subcrestal|place implant 2mm below crestal bone
16126493|NCT01961635|Device|platform-switch|abutment platform is narrow than implant diameter
16126494|NCT01961635|Procedure|one-time one-abutment|place the final abutment on the day of surgery and not remove it
16126495|NCT01961635|Procedure|Torque 20 n/cm2|the amount of torque applied to the abutment
16126496|NCT01961622|Device|Florence D2A or similar closed loop glucose control system|Subject's glucose level will be controlled by the Florence D2A or similar automated closed loop glucose control system. The system comprises of FreeStyle Navigator 2 ® Continuous Glucose Monitoring (CGM) System (Abbott Diabetes Care, Alameda, CA, USA), Dana R Diabecare subcutaneous insulin infusion pump (Sooil Corp. Seoul, South Korea)or similar insulin pump, and MPC-based glucose control algorithm running on a smartphone
16126497|NCT01961622|Device|CSII with real-time CGM|Subject glucose level controlled by usual insulin pump therapy in conjunction with real time continuous glucose monitoring (CGM)
16126498|NCT01961609|Biological|Secukinumab (AIN457)|Secukinumab was supplied in 150mg pre-filled syringes.
16126499|NCT01961596|Other|Cooling Ice Spray|"A bursts of the Cooling Ice Spray over a period of 10 seconds (15 cm distance) will be applied at the dominant foot in before each test."
16126500|NCT01961596|Other|water|A bursts of the water spray (room temperature over a period of 10 seconds (15 cm distance) will be applied at the dominant foot in before each test.
16126501|NCT01961583|Drug|18F-Fluciclatide|"Baseline 18F-Fluciclatide PET imaging will be obtained before starting of Pazopanib therapy(within 7 days).
~Subsequent 18F-Fluciclatide PET should be performed on 7 days after Pazopanib therapy"
16126502|NCT01961557|Device|EA-KAFO|This study tests a single device that contains multiple potential configurations as outlined in Table 1 of the protocol. Each participant be evaluated in multiple configurations, minimally including the baseline configuration and the motor assist condition at the knee.
16126503|NCT01961544|Drug|Eribulin mesylate|1.4 mg/m2 (as eribulin 1.23 mg/m2) day by 2-5 minutes IV on Day 1 and 8 every 21 days
16126504|NCT01961531|Device|Accuboost APBI|28Gy delivered in 5 daily fractions
16126505|NCT01961505|Drug|Topical compound tripterygium|Topical compound tripterygium was applied for the pain and swollen joints on non-woven fabric for 1 hour, twice per day.
16126506|NCT01961505|Drug|Placebo|The topical placebo recipe composes viscous agent which matches by the sucrose, and the usage and dosage were the same as the topical compound tripterygium group.
16126507|NCT01961492|Other|Fecal microbiota transplantation|A single fecal microbiota transplantation through colonoscope
16126509|NCT01961479|Other|Waiting list|During the waiting period, participants receive no treatment.
16126512|NCT01961453|Drug|Placebo capsule|One capsule of placebo administered once daily at 8 am.
16126513|NCT01961427|Dietary Supplement|sodium nitrate|Ingestion of 3mmol, 6mmol and 12mmol sodium nitrate
16126514|NCT01961427|Dietary Supplement|Beetroot juice|concentrated beetroot juice (dosage 3mmol, 6mmol and 12mmol)
16126515|NCT01961414|Drug|Aflibercept|Patients will receive Aflibercept 2.0mg intravitreal injection at all scheduled study visits
16126516|NCT01961401|Behavioral|exercise|
16126517|NCT01961388|Drug|Bay G5421 Glucobay|Oral, dosage of Acarbose as per the directions of treating physician
16126518|NCT01961388|Drug|Metformin|Oral, dosage of Metformin as per the directions of treating physician
16126520|NCT01961349|Drug|Intralipid|Treated by Anaesthesiologist. (Intralipid is being used as a placebo for Diprivan.)
16126521|NCT01961349|Drug|ICI35,868 (Diprivan)|Treated by Anaesthesiologist
16126522|NCT01961349|Drug|ICI35,868 (Diprivan) + EES0000645/A (SDS)|Treated by Endoscopist with EES0000645/A(SDS)
16126523|NCT01961336|Drug|Testosterone|10 mg of testosterone gel applied on the external side of the thigh for 21 days starting from the first day of menstruation prior to initiation of ovarian stimulation with rFSH for IVF/ICSI
16126524|NCT01961323|Drug|Nebivolol|Doses will be titrated based on weekly visits during the first 2 weeks to achieve a target SBP<140 and DBP <90 mm Hg. If BP remains uncontrolled after 2 weeks of treatment, indapamide will be added at a dosage of 2.5 mg/day. If the therapeutic goal is still not achieved by 4 weeks, patients will be withdrawn from the study.Upward titration will be halted, and the previous dosage level resumed, if at any point systolic blood pressure falls to ≤ 100 mmHg, even if the individual remains asymptomatic.
16126525|NCT01961310|Biological|Plasma analysis for bacterial translocation|1 ml of plasma will be obtained (blood sample). DNA will be extracted and amplified, and real-time quantitative PCR (polymerase chain reaction) performed.
16126526|NCT01961310|Biological|Stool analysis|DNA from stool samples will be extracted, amplified, and used to identify the bacteria species present.
16126527|NCT01961297|Drug|Sodium oxybate|Sodium oxybate
16126528|NCT01961284|Device|Zygomatic implant placement|
16126529|NCT01961284|Device|conventional implants and augmentation of maxilla|
16126530|NCT01961271|Drug|Buprenorphine transdermal patch|Please see Arm Description.
16126531|NCT01961258|Other|Computerized data base analysis and sampling of patients for outpatient clinic evaluation|
16126532|NCT01961245|Device|nocturnal non-invasive ventilation|patients will undergo a non-invasive ventilation during the night
16126533|NCT01961219|Procedure|Manipulation Under Anesthesia|Closed manipulation under anesthesia.
16126534|NCT01961219|Procedure|Arthroscopic capsular release|Arthroscopic capsular release
16126535|NCT01961206|Other|bacteremia caused by ESBL producing E.coli or K.pneumoniae|community-onset bacteremia caused by ESBL producing E.coli or K.pneumoniae
16126536|NCT01961193|Device|contact lens|A bandage contact lens will be inserted by a physician from the ophthalmology department within the first 24 hours of admission of the patient to the ICU. The position of the lens will be confirmed. The lens will remain in-situ as long as the patient is considered to require artificial lubrication or until discharge from the intensive care unit.
16126537|NCT01961193|Device|punctal plug|A punctal plug will be inserted into each eye. Lubricant drops ethylcellulose) will be instilled four times daily into each eye. The punctal plug will remain in-situ as long as the patient is considered to require artificial lubrication or until discharge from the intensive care unit at which time it will be removed by a physician from the ophthalmology department.
16126538|NCT01961180|Drug|Cipralex|the dosage is crescendo for one week and descending for two weeks with half dosage, to avoid side effects.
16126539|NCT01961180|Drug|Placebo|Placebo
16126540|NCT01961167|Device|Stenting of common and/or external iliacs|Balloon expandable stenting of iliac occlusive disease
16126541|NCT01961154|Drug|Asthma medication reduction|The asthma medications will be reduced in three steps up to total cessation of asthma drugs or up to asthma exacerbation. First step: Long-acting beta-agonist will be discontinued. The use of inhaled corticosteroids is continued, using the same dosage, preparation, and inhaler as before, for six weeks. Second step: medium to high daily inhaled corticosteroids dose is reduced to low daily dose, for six weeks. Third step: low inhaled corticosteroids dose will be stopped, for six weeks. Before each reduction, saline challenge will be performed.
16126542|NCT01961128|Behavioral|Exercise Intervention|
16126543|NCT01961115|Drug|Epacadostat|Given PO
16126544|NCT01961115|Biological|MELITAC 12.1 Peptide Vaccine|Given ID/SC
16126545|NCT01961102|Procedure|hysteroscopy/curettage in case of suspicious aspect will be done a rapid section|
16126546|NCT01961089|Device|Galilei Lens Professional|Measurement device
16126547|NCT01961089|Device|IOLMaster|Measurement device
16126548|NCT01961089|Device|Lenstar|Measurement device
16126549|NCT01961076|Other|overnight nutrition regime|Patients receive the specified overnight nutrition regimen
16126550|NCT01961063|Drug|busulfan|Given IV
16126551|NCT01961063|Biological|lentivirus vector rHIV7-shI-TAR-CCR5RZ-transduced hematopoietic progenitor cells|Given IV
16126552|NCT01961063|Other|pharmacological study|Correlative studies
16126553|NCT01961063|Other|laboratory biomarker analysis|Correlative studies
16126554|NCT01961050|Behavioral|Dual-Focused Brief Physician Intervention (DFBPI)|The DFBPI is incorporated in OB/GYN clinic visit. The intervention consists of two brief (5 to 10 minutes) manualized counseling segments delivered face-to-face by an OB/GYN in the context of two clinic visits.
16126555|NCT01961050|Other|Services as usual|Active Comparator: Standard OB/GYN clinic visits that include OB/GYN services as usual.
16126556|NCT01961037|Other|Tai Chi: Moving for Better Balance|Participants will attend one-hour Tai Chi classes twice weekly for 16 weeks.
16126557|NCT01960998|Behavioral|Pelvic Floor Muscle Training|Evidence-based pelvic floor muscle training program that has been adapted to telehealth format. Training is begun 2-4 weeks before surgery and continued 2 months after surgery. Content is accessed in daily 10-minute sessions on a secure website
16126620|NCT01960504|Device|Percutaneous Coronary Intervention (DREAMS) stenting|
16126766|NCT01959477|Drug|busulfan|Given IV
16126558|NCT01960998|Behavioral|Perioperative Care and Wetness Management|Telehealth program that includes include general perioperative care; wetness, odor and skin care management; and outcome measures. The program is begun 1-4 weeks before surgery and continued 2 months after surgery. Content is accessed in 10-minute sessions on a secure website - daily preoperatively and for the first 2 months post-operatively, then weekly until 6 months post-operatively.
16126559|NCT01960985|Other|Physicaltherapy|
16126560|NCT01960972|Other|Salt substitute|A salt substitute using 25% of potassium chloride and 75% of sodium chloride will be implemented in each of the villages.
16126561|NCT01960946|Dietary Supplement|Modified Citrus Pectin (MCP) vs placebo|5 grams by mouth three times a day
16126562|NCT01960933|Procedure|Percutaneous coronary intervention|
16126563|NCT01960933|Procedure|FFR|
16126564|NCT01960920|Other|Filtered diesel exhaust|Mask-filtered exposure to diesel exhaust
16126565|NCT01960920|Other|Unfiltered diesel exhaust|Diesel Exhaust Inhalation
16126566|NCT01960920|Other|Clean air|No pollution and no filter mask
16126567|NCT01960907|Device|CHROMED monitoring system|Optimization of patient's treatment according to the data collected by the home monitoring devices
16126568|NCT01960868|Other|standard physiotherapy|
16126569|NCT01960868|Other|experimental physical therapy|
16126570|NCT01960855|Drug|ABT-494|ABT-494 capsule administered orally twice daily (BID).
16126571|NCT01960855|Drug|Placebo|Placebo for ABT-494 capsule administered orally twice daily (BID).
16126572|NCT01960842|Drug|Levodopa-carbidopa intestinal gel|Dose levels will be individually optimized. Infusion should be kept within a range of 0.5-10 mL/hour (10-200 mg levodopa/hour) and is usually 2-6 mL/hour (40-120 mg levodopa/hour)
16126573|NCT01960842|Device|CADD-Legacy® 1400 ambulatory infusion pump|
16126574|NCT01960842|Device|PEG tube|percutaneous endoscopic gastrostomy tube
16126575|NCT01960842|Device|J-tube|jejunal tube
16126576|NCT01960829|Drug|Everolimus|
16126577|NCT01960816|Device|Procedure: thermal coagulation of tissue in the nasal airway|The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage.
16126578|NCT01960803|Radiation|Intraoperative Electron Radiotherapy|Intraoperative Electron Radiotherapy (IOERT) is delivered after completion of the lumpectomy and sentinel node procedure.
16126579|NCT01960777|Procedure|Onstep|
16126580|NCT01960777|Procedure|Laparoscopic repair|
16126581|NCT01960764|Drug|Pre-Treatment with Dial liquid antibacterial soap|This arm will be pre-treated with Dial liquid antibacterial soap and alcohol prior to the autologous microbiome transplant.
16126582|NCT01960764|Other|Control|
16126583|NCT01960751|Other|neurocognitive tests battery|The two groups (exposed: 0.05 to 1 Gy; unexposed: less than 0.05 Gy) will receive the same neurocognitive tests battery.
16126584|NCT01960738|Other|A pre-dive checklist|The pre-dive checklist included a checklist of tasks to be undertaken before the dive, a dive-plan that asked the diver to plan the depth, and amount of gas kept at different levels of diving, and 4 dive tips.
16126585|NCT01960725|Biological|RV5 (Pentavalent Rotavirus Vaccine)|
16126586|NCT01960712|Device|Transpapillary plastic stent (7-10 Fr)|Duodenoscopy plus transpapillary bile cannulation plus stent insertion.
16126587|NCT01960686|Biological|Low dose RSV F Antigen|
16126588|NCT01960686|Biological|High dose RSV F Antigen|
16126589|NCT01960686|Biological|Dose 1 of Aluminum Adjuvant|
16126590|NCT01960686|Biological|Dose 2 of Aluminum Adjuvant|
16126591|NCT01960686|Biological|Dose 3 of Aluminum Adjuvant|
16126592|NCT01960686|Biological|Dose 4 of Aluminum Adjuvant|
16126593|NCT01960686|Biological|Placebo|
16126594|NCT01960673|Device|LMA proseal|It would be used to observe the leak pressure at 30,45,60 degree of the head and neck position and the condition between the vocal cord and peri-laryngeal region. The cuff pressure would be kept at 30 cm H20.
16126595|NCT01960673|Device|igel LMA|It would be used to observe the leak pressure at 30,45,60 degree of the head and neck position and the condition between the vocal cord and peri-laryngeal region.
16126596|NCT01960673|Device|air Q LMA|It would be used to observe the leak pressure at 30,45,60 degree of the head and neck position and the condition between the vocal cord and peri-laryngeal region. The cuff pressure would be kept at 30 cm H20.
16126597|NCT01960673|Device|ambu LMA|It would be used to observe the leak pressure at 30,45,60 degree of the head and neck position and the condition between the vocal cord and peri-laryngeal region. The cuff pressure would be kept at 30 cm H20.
16126598|NCT01960660|Dietary Supplement|Omega-3 Fatty Acids|
16126599|NCT01960647|Device|Percutaneous transluminal angioplasty with uncoated balloon|
16126600|NCT01960647|Device|Percutaneous transluminal angioplasty with Paclitaxel balloon|
16126601|NCT01960621|Drug|cyclodextrin|intravenous
16126602|NCT01960608|Other|24_hours_urine_sodium|
16126603|NCT01960595|Procedure|IV fentanyl PCA|
16126604|NCT01960595|Procedure|local bupivacaine infiltration and post-OP IV fentanyl PCA|
16126605|NCT01960595|Procedure|Nerve Blocks and post-OP IV fentanyl PCA|
16126606|NCT01960582|Behavioral|New Practice Strategy|Application of a structured case management strategy on housing adaptation cases
16126607|NCT01960569|Drug|active product ( Thrombexx) assigned to arm 1|Dispense 2-3 cm of cream or gel, 2-3 times per day and carry out a light massage until complete
16126608|NCT01960569|Other|Placebo assigned to arm 2|
16126609|NCT01960556|Other|Simulation Training|Simulation training provided to one group
16126610|NCT01960543|Drug|fentanyl 15 microg|
16126611|NCT01960543|Drug|Bupivacaine 7 mg|
16126612|NCT01960543|Drug|Bupivacaine 9 mg|
16126613|NCT01960543|Drug|Levobupivacaine 7 mg|
16126614|NCT01960543|Drug|Levobupivacaine 9 mg|
16126615|NCT01960530|Drug|Hydrocortisone granules|Multi-particulate granules
16126616|NCT01960530|Drug|Hydrocortisone Tablet|Standard hydrocortisone tablets
16126617|NCT01960530|Drug|i.v. Hydrocortisone Injection|Standard hydrocortisone solution for intravenous injection
16126618|NCT01960530|Other|Dexamethasone|Challenge agent
16126619|NCT01960517|Device|ACS Catheter|
16126767|NCT01959477|Drug|etoposide|Given IV
16126621|NCT01960491|Device|Device Closure of Atrial Septal Defect|"Device Closure of Atrial Septal Defect by Carag Bioresorbable Septal Occluder"
16126622|NCT01960478|Biological|(for each intervention)|
16126623|NCT01960478|Other|Blood test|
16126624|NCT01960465|Device|Continuous positive airway pressure|A portable ventilatory assist device, which is the standard first line treatment of sleep apnea.
16126625|NCT01960452|Behavioral|Serial awakenings|The first study night will be a baseline sleep recording. The second night will consist of a series of awakenings (using auditory tones) and subsequent periods of falling back asleep in order to examine the cortical dynamics of hyperarousal or other dysfunction during these two critical sleep processes in insomnia.
16126626|NCT01960426|Other|Measurement of drug (Adalimumab/Infliximab)|Measurement of drug (adalimumab/infliximab) and ADAs in the presence of drug.
16126627|NCT01960426|Other|Intensify treatment with the existing drug|Intensify treatment with the existing drug and if this fails empirically switch to another TNF antagonist
16126628|NCT01960413|Drug|Montelukast added to Hydroxyurea|
16126629|NCT01960413|Drug|Placebo added to Hydroxyurea|
16126630|NCT01960400|Device|transcranial direct current stimulation (tDCS) (active or placebo)|TDCS was delivered according to the method described by Fregni et al. (2006) and the safety parameters related to tDCS application were respected (DaSilva et al., 2011). Direct current was delivered using a battery-driven constant current stimulator coupled to saline-soaked (0.9% NaCl) sponge electrodes (5 X 7 cm). Anodal stimulation was delivered over the M1; the anode was placed over C3 or C4 position in the 10/20 system for the EEG electrode position, contralateral to the affected limb, and the cathode over the opposite supraorbital area (i.e. ipsilateral to the affected limb). In the laboratory, a constant current of an intensity of 2 mA was applied for 20 min/day X 5 consecutive days during the first and the second weeks of GMI. To help maintain the potential effects of the neurostimulation, the tDCS was also applied simultaneously with GMI once a week during the 2 other phases until the end of the six weeks GMI program, for a total of 14 treatment sessions.
16126631|NCT01960400|Device|Graded motor imagery (GMI)|The treatment was performed using a software (Recognise™ online) provided by NOI group (http://www.noigroup.com/recognise). As an alternative to the software (for patients without an internet access), the patient could do the exercises with a Recognise™ Flash Cards set consists of 25 left and 25 right matching images (upper limb or lower limb). Using standardized procedures, inspired from the randomized controlled trial conducted by Moseley (2004, 2006), the participants performed the therapy at home, 10 minutes per session, 3x/day, 6 days/week, using the computer software and a mirror box (Lagueux et al., 2012).
16126632|NCT01960387|Drug|Clofarabine|Clofarabine will be administered as a 1-hour (range: 1 hour minimum to 2 hours maximum) intravenous infusion at a dose of 40mg/m2 daily on days 1 through 5.
16126633|NCT01960387|Drug|Cytarabine|Cytarabine at a dose of 1g/m2 daily will be given as a 2-hour intravenous infusion, starting 3 hours after the completion of clofarabine administration on days 1 through 5.
16126634|NCT01960374|Drug|Selumetinib|1, 2 or 3 x 25 mg selumetinib (AZD6244; ARRY-142886) (Hyd-Sulfate) capsule administered orally as a single dose on Day 1 of the study (total dose 25 mg, 50 mg and 75 mg respectively) with 240 ml of water at room temperature.
16126635|NCT01960361|Device|ICE dental implant|ICE- Implant Classical Esthetic implant
16126636|NCT01960348|Drug|patisiran (ALN-TTR02)|administered by intravenous (IV) infusion
16126637|NCT01960348|Drug|Sterile Normal Saline (0.9% NaCl)|administered by intravenous (IV) infusion
16126638|NCT01960335|Dietary Supplement|Whey Protein|Whey protein provided in 20 gram servings administered three times per day. once in the morning upon waking; a second serving in the mid-afternoon; and a third serving within 2 hours of going to sleep at night.
16126639|NCT01960335|Dietary Supplement|Whey Protein and Resistance Exericse|Subjects will receive 20 grams of whey protein three times per day along with 4 days per week of resistance exercise training throughout the 16 week intervention.
16126640|NCT01960335|Other|Whey Protein and RISE exercise routine|Subjects will consume 20 grams of whey protein three times per day (total of 60 grams) and perform a combination of exercise involving functional resistance exercise (R); sprint intervals (I); stretching/pilates/yoga (S); and endurance exercise (E); RISE four days per week.
16126641|NCT01960322|Behavioral|Telemetric|A manualized behavioral management approach focusing on avoidance and addressing barriers to adherence, delivered via telephone or internet chat applications.
16126642|NCT01960309|Other|Minimal invasive cardiac imaging|"Coronary CT angiography (CCTA)
~Coronary magnetic resonance imaging (CMR)
~Echocardiography"
16126643|NCT01960296|Drug|Clopidogrel|Continue home dose of clopidogrel into surgery
16126644|NCT01960296|Drug|Discontinue Clopidogrel|Discontinue home dose of clopidogrel one week before surgery. Resume after surgery.
16126645|NCT01960283|Drug|Methotrexate (Novatrex ®) + anti-H1|"Methotrexate (Novatrex ®) tablets 2.5 mg methotrexate 0.2 mg/kg/week as a single dose, orally for 8 weeks.
~After 8 weeks, if the treatment is still not efficient, the dose will be increased to 0.25 mg/kg/week and continued until W18.
~For anti-H1 treatment, the same molecules with the same dosage than before the recruitment will be continued, and methotrexate will be added in this group."
16126646|NCT01960283|Drug|Placebo + anti-H1|"Placebo: 0.2 mg / kg / week as a single dose, orally for 8 weeks. After eight weeks, if the patient is still very embarrassed, the dose is increased to 0.25 mg / kg / week in a weekly dose.
~For anti-H1 treatment, the same molecules with the same dosage than before the recruitment will be continued, and the placebo of methotrexate will be added in this group."
16126647|NCT01960270|Device|Device: INTERSTIM II|A second stimulator is implanted on controlateral site
16126648|NCT01960257|Device|Digital Health Feedback System|This intervention uses an ingestion sensor and a wearable sensor (worn as a patch on the skin), which are new technologies approved by the FDA, to collect information about patients taking their TB medications. The wearable sensor records information, which is uploaded wirelessly to a mobile device and then to a secure computer. Together the sensors and the mobile device transmitting the information to the study computer are called a digital health feedback system (DHFS), which provides information about when patients have taken their TB medications.
16126649|NCT01960257|Other|SOC DOT|
16126650|NCT01960231|Other|OGTT|
16126651|NCT01960205|Drug|Saxagliptin|5mg a day for 6 months
16126652|NCT01960205|Drug|saxagliptin|2.5 mg a day for 6 months
16126653|NCT01960205|Drug|metformin|500mg three times a day for 6 months
16126654|NCT01960205|Other|lifestyle intervention|lifestyle intervention for 6 months
16126655|NCT01960192|Drug|HD-MTX-Ara-C regimen|high-does metrotrexate 3.5g/m2 d1 ivgtt 6h,cytarabine 1g/m2 bid d2-3.Continued use to the end of chemotherapy .Every 21 days for one cycle and four cycles are required. Efficacy was evaluated every two cycles
16126656|NCT01960192|Drug|FVD regimen|FVD regimen(fotemustine, teniposide and dexamethasone),fotemustine 100mg/m2 d1 ivgtt,teniposide 60mg/m2 d2-4 ivgtt,dexamethasone 40mg d1-5 ivgtt.Continued use to the end of chemotherapy .Every 21 days for one cycle and four cycles are required. Efficacy was evaluated every two cycles
16126657|NCT01960179|Drug|lixisenatide AVE0010|Pharmaceutical form:solution Route of administration: Subcutaneous injection
16126658|NCT01960166|Behavioral|Active Distraction|iPad will be used as active distraction
16126659|NCT01960166|Behavioral|Passive Distraction|child will watch TV as passive distraction
16126660|NCT01960153|Drug|Tadalafil|Tadalafil tablets, 20 mg to 40 mg per day x 48 weeks
16126661|NCT01960153|Drug|Placebo|Placebo of tadalafil. Subjects will take one tablet once per day and will be titrated to two tablets once per day after one week. Subjects are on study drug for the duration of the trial.
16126662|NCT01960140|Drug|Baricitinib|Administered orally
16126663|NCT01960140|Drug|Simvastatin|Administered orally
16126664|NCT01960127|Behavioral|Aerobic exercise|
16126665|NCT01960114|Drug|Acetaminophen ER|Single dose (2 tablets) Acetaminophen ER 750 mg
16126666|NCT01960114|Drug|Placebo|Single dose (2 tablets) Acetaminophen ER 750 mg matching placebo
16126667|NCT01960101|Other|LactoXeros|
16126668|NCT01960101|Device|Aequasyal|
16126669|NCT01960088|Drug|HPV vaccine|
16126670|NCT01960075|Drug|Fosphenytoin|
16126671|NCT01960075|Drug|Levetiracetam|
16126672|NCT01960075|Drug|Valproic acid|
16126673|NCT01960062|Device|Diabetes software and device|USB cord, CD-rom, and application to allow communication with provider
16126674|NCT01960049|Procedure|ropivacaine + iv PCA|
16126675|NCT01960049|Procedure|saline and IV PCA|
16126676|NCT01960036|Behavioral|Mindful Awareness in Body-oriented Therapy|
16126677|NCT01960036|Behavioral|Womens Health Education|
16126680|NCT01960010|Drug|MIM-D3 Ophthalmic Solution|1% MIM-D3 dosed BID
16126681|NCT01960010|Drug|Vehicle|Vehicle dosed BID
16126682|NCT01959997|Procedure|Redo PVI|
16126683|NCT01959997|Procedure|PVI + RDN|
16126684|NCT01959984|Other|100g Standard Noodles|Subjects are required to take 100g standard noodles,and then blood samples are collected at 0min,30min,60min,120min,180min.
16126685|NCT01959984|Other|75g Oral Glucose|Subjects are required to take 75g glucose solution,and then blood samples are collected at 0min,30min,60min,120min,180min.
16126686|NCT01959971|Drug|alirocumab|"Pharmaceutical form:Solution for injection
~Route of administration: Subcutaneous"
16126687|NCT01959971|Drug|Placebo|"Pharmaceutical form:Solution for injection
~Route of administration: Subcutaneous"
16126688|NCT01959958|Other|Questionnaire/Interview|Participants will each complete an interview with questionnaires assessing nocturnal enuresis, health-related quality of life, emotional and behavioral functioning, family functioning, and stressful life events. Participants who report nocturnal enuresis will also be asked to identify interventions they have used in the past, along with barriers to intervention implementation.
16126689|NCT01959945|Biological|Flublok® Quadrivalent Influenza Virus Vaccine|Intramuscular (Relevant year formulation)
16126690|NCT01959945|Biological|Fluarix Quadrivalent® Influenza Virus Vaccine|Intramuscular (Relevant year formulation)
16126691|NCT01959932|Other|Tobacco Heating System (THS 2.2)|THS 2.2 ad libitum for 5 days in confinement
16126692|NCT01959932|Other|Smoking abstinence (SA)|SA for 5 days in confinement
16126693|NCT01959932|Other|Conventional cigarette (CC)|Subject's own preferred brand of CC ad libitum for 5 days in confinement
16126694|NCT01959919|Device|Refacto FusENGO|Dosage will be chosen by PI based on patient condition.
16126695|NCT01959880|Device|The Contour Profile Gel (CPG) breast implants|"The CPG mammary prosthesis is a silicone elastomer mammary device with a textured surface. The Siltex® (textured) shell consists of a smooth shell bonded to an additional layer of silicone that has a textured pattern imprinted into its surface. The Siltex® shell is textured to provide a disruptive surface for collagen interface. The CPG implant contains a gel that is a more cohesive silicone gel than that used in other Mentor gel implants. The gel is made from the same materials as Mentor's standard gel. The contour shape of the CPG is designed to provide inferior projection with reduced superior fullness. The CPG mammary prosthesis contains raised orientation marks on the anterior and posterior of the implant which may help the physician ensure proper placement.
~The Contour Profile Gel is available in sizes 125cc - 690cc and 4 styles with various projection and height options in this study."
16126696|NCT01959867|Device|SurgiMend® PRS|Subjects enrolled in to this cohort will receive SurgiMend® PRS (ADM) product during the first stage of the reconstruction (expander insertion).
16126697|NCT01959867|Other|No Intervention|Subjects enrolled in to this cohort will not receive an acellular dermal matrix (ADM) product during the first stage of the reconstruction (expander insertion).
16126698|NCT01959854|Device|carboxymethylcellulose|0.25% carboxymethylcellulose preservative free
16126699|NCT01959854|Device|xanthan gum|0.2% xanthan gum preservative free
16126700|NCT01959841|Drug|ASP2151|200 mg once daily or 400 mg once daily
16126701|NCT01959841|Drug|valaciclovir|1000 mg three times daily
16126702|NCT01959828|Drug|IK-3001|
16126703|NCT01959802|Procedure|Vitrectomy|
16126704|NCT01959776|Procedure|Vitrectomy|
16126705|NCT01959763|Behavioral|Weight loss counseling program|Randomized study persons are given either one of the two different methods of weight loss counseling program without ICT or with ICT-based counseling. As a control for the study groups one group is receiving only ICT-based counseling and one group does not receive any of the counseling methods.
16126706|NCT01959750|Behavioral|problem-based sessions|weekly sessions for small groups of caregivers, led by two psychologists acting as moderators and using a systemic approach, as suggested in other peer-support groups using a problem-based method
16126707|NCT01959737|Procedure|skin-to.skin-contact|Immediately after initial stabilization/ assessment of the VLBW infant, skin-to-skin contact of mother and infant is initiated and kept up for 60 minutes.
16126708|NCT01959724|Other|Vitrectomy|
16126709|NCT01959711|Procedure|Posterior RA|Posterior retroperitoneoscopic adrenalectomy
16126710|NCT01959711|Procedure|Lateral transperitoneal LA|Lateral transperitoneal laparoscopic adrenalectomy
16126711|NCT01959698|Drug|Carboplatin|Given IV
16126712|NCT01959698|Drug|Carfilzomib|Given IV
16126713|NCT01959698|Drug|Etoposide|Given IV
16126714|NCT01959698|Drug|Ifosfamide|Given IV
16126715|NCT01959698|Other|Laboratory Biomarker Analysis|Correlative studies
16126716|NCT01959698|Other|Pharmacological Study|Correlative studies
16126717|NCT01959698|Biological|Rituximab|Given IV
16126718|NCT01959685|Drug|Androxal|125 mg Androxal, 250 mg Androxal separated by at least 7 days
16126719|NCT01959685|Drug|Placebo|Placebo, single dose
16126720|NCT01959672|Procedure|4-Dimensional Computed Tomography|Correlative studies
16126721|NCT01959672|Drug|Fluorouracil|Given IV
16126722|NCT01959672|Drug|Gemcitabine Hydrochloride|Given IV
16126723|NCT01959672|Other|Laboratory Biomarker Analysis|Correlative studies
16126724|NCT01959672|Drug|Leucovorin Calcium|Given IV
16126725|NCT01959672|Drug|Nelfinavir Mesylate|Given PO
16126726|NCT01959672|Biological|Oregovomab|Given IV
16126727|NCT01959672|Radiation|Stereotactic Body Radiation Therapy|Undergo SBRT
16126728|NCT01959672|Procedure|Therapeutic Conventional Surgery|Undergo surgical resection
16126729|NCT01959646|Dietary Supplement|Aged Garlic Extract Supplementation Group|Subjects will be asked to consume three (3) capsules of 600 mg aged garlic extract (AGE) with food twice a day, for a total of 3.6 grams per day.
16126730|NCT01959646|Other|Standard for Groups|To assess for eligible study participants, the research team will use the Cholestech LDX® System (Alere™ Inc, Waltham, MA) to analyze finger-prick blood samples. This is an efficient and economical point of care testing for c-Reactive Protein (CRP), cholesterol and related lipids, and blood glucose, as diagnostic tools which provide information for immediate risk assessment and therapeutic monitoring of heart disease, inflammatory disorders and diabetes. Each finger prick will be treated individually.
16126731|NCT01959646|Dietary Supplement|Placebo|Participants will be asked to consume three (3) placebo capsules with food twice a day.
16126732|NCT01959633|Drug|Vemurafenib|Vemurafenib 960 mg b.i.d. for each course of treatment lasting 28 days
16126733|NCT01959633|Drug|Peg-interferon|"In the Phase I are included 3 cohorts. Cohort 1) Peg-interferon 1 µg/Kg one time per week s.c. Cohort 2) Peg-interferon 2 µg/Kg one time per week s.c. Cohort 3) Peg-interferon 3 µg/Kg one time per week s.c. Interferon treatment should start after 15 days of Vemurafenib only
~In the Phase II is included the cohort selected by phase I due to MTD and expanded at RD."
16126734|NCT01959633|Drug|Cobimetinib|Cobimetinib 60 mg o.d. (21 days on followed by 7 days off)
16126735|NCT01959620|Behavioral|1-Session Exposure Therapy|One exposure therapy session lasting one hour
16126736|NCT01959620|Behavioral|3-Session Exposure Therapy|Three exposure therapy sessions lasting one hour each, delivered one week apart
16126737|NCT01959607|Other|THS 2.2|Single use of the Tobacco Heating System 2.2 (THS 2.2)
16126738|NCT01959607|Other|CC|Single use of subject's own cigarette (CC)
16126739|NCT01959607|Other|NRT Gum|Single administration of the nicotine replacement therapy (NRT) 2 mg gum (Nicorette® 2mg)
16126740|NCT01959594|Drug|3 mg PF-06412562|oral dosing of 3 mg PF-06412562 tablets three times a day for 14 days
16126741|NCT01959594|Drug|10 mg PF-06412562|oral dosing of 10 mg PF-06412562 tablets three times a day for 14 days
16126742|NCT01959594|Drug|25 mg PF-06412562|oral dosing of 25 mg PF-06412562 tablets three times a day for 14 days
16126743|NCT01959594|Drug|PF-06412562 TBD mg|oral dosing of PF-06412562 tablets three times a day for 14 days. Dosage and frequency to-be-determined based on previous cohorts
16126744|NCT01959594|Drug|PF-06412562 TBD mg|oral dosing of PF-06412562 tablets three times a day for 14 days. Dosage and frequency to-be-determined based on previous cohorts
16126745|NCT01959581|Device|Movement Enhancing Device|Naturalistic play activities using the hands while wearing the movement enhancing device.
16126746|NCT01959568|Procedure|Vitrectomy and tamponade|"In the double tamponade arm the result of surgery is vitreous cavity filled in a half with perfluorodecalin and in another half - with silicone oil.
~In the silicone oil tamponade arm the result of surgery is vitreous cavity filled with conventional or heavy silicone oil, depending on predominant retinal breaks location."
16126747|NCT01959555|Other|No treatment given|Patients will not be treated with any specific product. Data collection only.
16126748|NCT01959542|Device|MRI|
16126749|NCT01959542|Other|PSA Blood Test|Serum PSA will also be subsequently checked on the same day as each follow-up MR is performed, i.e. TP 1, 2 and 3, and right after finishing EBRT. 1-2 mls of blood will be sampled per blood test.
16126750|NCT01959529|Drug|insulin degludec|Injected once daily subcutaneously (s.c., under the skin)
16126751|NCT01959529|Drug|insulin glargine|Injected once daily subcutaneously (s.c., under the skin)
16126752|NCT01959516|Drug|Glycopyrronium|Glycopyrronium capsule for inhalation once per day via SDDPI
16126753|NCT01959516|Drug|Tiotropium|Tiotropium capsule for inhalation once per day via HandiHaler® device
16126754|NCT01959516|Drug|Placebo to glycopyrronium|Placebo to glycopyrronium capsule for inhalation once per day via SDDPI
16126755|NCT01959516|Drug|Placebo to tiotropium|Placebo to tiotropium capsule for inhalation once per day via HandiHaler® device
16126756|NCT01959503|Device|Progel Vascular Sealant|
16126757|NCT01959503|Device|Gelfoam Plus|
16126758|NCT01959490|Biological|trastuzumab|Given IV
16126759|NCT01959490|Biological|Pertuzumab|Given IV
16126760|NCT01959490|Drug|docetaxel|Given IV
16126761|NCT01959490|Drug|carboplatin|Given IV
16126762|NCT01959490|Drug|doxorubicin|Given IV
16126763|NCT01959490|Drug|cyclophosphamide|Given IV
16126768|NCT01959477|Drug|cyclophosphamide|Given IV
16126769|NCT01959477|Procedure|peripheral blood stem cell transplantation|Undergo autologous peripheral blood stem cell transplant
16126770|NCT01959477|Procedure|autologous hematopoietic stem cell transplantation|Undergo autologous peripheral blood stem cell transplant
16126771|NCT01959464|Drug|Crinone vaginal progesterone gel|Crinone vaginal progesterone gel is inserted in the female vaginal using the pre-filled applicator.
16126772|NCT01959464|Drug|Placebo vaginal gel|Placebo vaginal gel is inserted in the female vagina using the pre-filled applicator.
16126773|NCT01959451|Drug|Prasugrel|see Arm description
16126774|NCT01959451|Drug|Clopidogrel|see arm description
16126775|NCT01959438|Drug|Sodium selenite (Introselen)|Intravenous infusion daily for each week day during 2 weeks (10 infusions). After that chemotherapy during 6 weeks. Chemotherapy for each patients is the first line treatment, so chemotherapy differs among patients, with respect to which treatment a patient got as first line.
16126776|NCT01959438|Drug|Sodium selenite|Intravenous treatment as described above. Cohorts of 3 patient are given a fixed dose for daily treatment (started with 0.5 mg/m2) and if no grade 3 or 4 toxicity, a new cohort is started on a higher dose. The dose for next cohort is 50% higher than for the former cohort. If grade 3 or 4 toxicity is found in 1 patient, 3 more patients are included on the same dose and if one more patient has serious toxicity it is considered to high a dose and a dose in between the toxic dose and the one before is tested. Thus if 2 patients in 3-6 tested patients has serious toxicity by a certain dose, this dose is to high and the highest dose is considered the earlier tested dose.
16126777|NCT01959425|Other|Off OAT Group (Test)|Discontinuation of OAT Therapy
16126778|NCT01959425|Other|On OAT Group (Control)|Continuation of OAT Therapy
16126779|NCT01959412|Drug|Indacaterol 27.5 mcg|indacaterol 27.5 mcg twice daily inhaled once via inhaler
16126780|NCT01959412|Drug|Indacaterol 37.5|Indacaterol 37.5 mcg once daily, inhaled once via inhaler
16126781|NCT01959412|Drug|Indacaterol 55 mcg|Indacaterol 55 mcg once daily, inhaled once via inhaler
16126782|NCT01959412|Drug|Indacaterol 75 mcg|Indacaterol 75 mcg once daily, inhaled once via inhaler
16126783|NCT01959412|Drug|Indacaterol 150 mcg|Indacaterol 150 mcg once daily, inhaled once via inhaler
16126784|NCT01959412|Drug|Placebo|Placebo to indacaterol once or twice daily (depending on assigned sequence) via inlaher
16126785|NCT01959399|Drug|ASP015K|oral tablet
16126786|NCT01959399|Drug|Rosuvastatin|oral tablet
16126787|NCT01959386|Drug|Trastuzumab|Participants will be receiving trastuzumab as part of their treatment for breast cancer according to the judgement of physician and according to the actual summary of product characteristics. The study protocol does not influence the physician's decision regarding diagnostics, therapy or frequency of medical examination during or after the treatment.
16126788|NCT01959373|Procedure|electroencephalograms (EEG)|
16126789|NCT01959373|Procedure|electro-myography (EMG)|
16126790|NCT01959360|Procedure|Direct lateral|Total hip replacement; direct lateral approach
16126791|NCT01959360|Procedure|minimal invasive|Total hip replacement; minimal invasive approach
16126792|NCT01959360|Procedure|modified minimal invasive|Total hip replacement; modified minimal invasive approach
16126793|NCT01959347|Procedure|Miduretheral Sling|MUS can include the TVT™ (mechanical cut mesh only, Gynecare, ETHICON Women's Health & Urology, Somerville, NJ), TVT-O™ (mechanical cut mesh only, Gynecare), or Monarc™ (American Medical Systems, Minnetonka, MN).
16126794|NCT01959347|Other|Miduretheral Sling with behavioral/pelvic floor therapy|MUS is combined with components of behavioral therapy (designed to change behaviors to encourage continence), and pelvic floor muscle therapy (designed to strengthen the pelvic floor muscles, enhance the physiological closure of the bladder neck, and improve coordination). This is done prior to MUS (1 visit) and after MUS for 5 visits at 2, 4, 6, 8 weeks and 6 months.
16126795|NCT01959334|Drug|Nasal Glucagon (NG)|
16126796|NCT01959334|Drug|Glucagon IM|
16126797|NCT01959295|Drug|ASP2151|200 mg once daily
16126798|NCT01959295|Drug|ASP2151 placebo|once daily
16126799|NCT01959282|Drug|Placebo|Participants will receive placebo once daily
16126800|NCT01959282|Drug|JNJ-54781532 25 mg once daily|Participants will receive 25 mg of JNJ-54781532 once daily
16126801|NCT01959282|Drug|JNJ-54781532 75 mg once daily|Participants will receive 75 mg of JNJ-54781532 once daily
16126802|NCT01959282|Drug|JNJ-54781532 150 mg once daily|Participants will receive 150 mg of JNJ-54781532 once daily
16126803|NCT01959282|Drug|JNJ-54781532 75 mg twice daily|Participants will receive 75 mg of JNJ-54781532 twice daily
16126804|NCT01959269|Drug|Regorafenib (Stivarga, BAY 73-4506)|As determined by the treating physician
16126805|NCT01959256|Behavioral|Visual perceptual learning|24 times of training for visual perceptual learning
16126806|NCT01959243|Drug|Brimonidine Tartrate|Ophthalmic solution to be applied as directed.
16126807|NCT01959243|Drug|Vehicle|Ophthalmic solution to be applied as directed.
16126808|NCT01959243|Drug|Sodium Fluorescein|For use as needed during the study for evaluating corneal damage.
16126809|NCT01959243|Drug|Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP|For use as needed during the study for intraocular pressure and dilated ophthalmoscopy.
16126810|NCT01959230|Drug|Brimonidine Tartrate|Ophthalmic solution to be applied as directed.
16126811|NCT01959230|Drug|Vehicle|Ophthalmic solution to be applied as directed.
16126812|NCT01959230|Drug|Sodium Fluorescein|For use as needed during the study for evaluating corneal damage.
16126813|NCT01959230|Drug|Fluorescein Sodium and Benoximate Hydrocholoride Ophthalmic Solution USP|For use as needed during the study for intraocular pressure and dilated ophthalmoscopy.
16126814|NCT01959217|Behavioral|PM Component Text Reminders|The number of PM components (strategic encoding, monitoring, and cue salience) that will comprise the tailored text reminders will be determined by Phase 1.
16126815|NCT01959204|Drug|Oxycodone|Pain
16126816|NCT01959191|Drug|Dual antiplatelet therapy including aspirin and clopidogrel after off-pump coronary bypass surgery|aspirin 100mg/day and clopidogrel 75mg/day, PO, from the day of surgery for 1 year
16126999|NCT01957826|Other|placebo intervention|placebo administration
16127250|NCT01955759|Drug|beta blockers Bisoprolol in adjusted dose|starting 7 days befoe coronary by-pass surgery
16126817|NCT01959178|Device|LD127025 MF|At Visit 1, one-half of the subjects will be randomized to receive the investigational soft contact lens, after approximately one week of wearing the first lens type, the subjects will return for the 1-Week Crossover Visit (Visit 2) for an exam, and to determine if the subject remains eligible to continue in the next phase of the study with the control soft contact lens.
16126818|NCT01959178|Device|Air Optix Aqua MF|At Visit 1, one-half of the subjects will be randomized to receive the control soft contact lens, after approximately one week of wearing the first lens type, the subjects will return for the 1-Week Crossover Visit (Visit 2) for an exam, and to determine if the subject remains eligible to continue in the next phase of the study with the investigational soft contact lens.
16126819|NCT01959165|Drug|MEDI7183 low dose|MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8
16126820|NCT01959165|Drug|MEDI7183 medium dose|MEDI7183 will be administered by SC on Day 1, Week 2, 4, and 8
16126821|NCT01959165|Drug|MEDI7183 high dose|MEDI7183 will be administered by SC on Day 1, and placebo for MEDI7183 at Week 2, 4, and 8
16126822|NCT01959165|Drug|Matching Placebo|Placebo will be administered by SC on Day 1, Week 2,4, and 8
16126823|NCT01959152|Device|HiRes™ 90K Advantage implant with HiFocus™ Mid-Scala electrode|
16126824|NCT01959139|Drug|PEGPH20|3 ug/kg on Day 1, IV over 15 minutes
16126825|NCT01959139|Drug|Oxaliplatin|85 mg/m^2, on Day 2, IV over 2 hours
16126826|NCT01959139|Drug|Leucovorin|400 mg/m^2, on Day 2, IV over 2 hours
16126827|NCT01959139|Drug|Irinotecan|180 mg/m^2, on Day 2, IV over 1.5 hours
16126828|NCT01959139|Drug|5-fluorouracil|2,400 mg/m^2, Days 2-4, IV over 46 hours
16126829|NCT01959126|Behavioral|Stress-reduction class|Study participants enrolled in a 12-week stress reduction course based on the principles of mindfulness. They attended four six-hour workshops and participated in 12 weekly hour-long web video conferencing calls to reinforce what was taught in the workshops. We have two groups: chronically-stressed maternal caregivers of children on the autism spectrum and control mothers whose children have no significant psychiatric or physical impairment. Both groups received similar instruction.
16126830|NCT01959113|Biological|Autologous Microbiome Transplant|
16126831|NCT01959113|Other|Placebo Arm|
16126832|NCT01959100|Drug|Azithromycin|250 mg x 3/week per os during a meal for a period of 2 years
16126833|NCT01959100|Drug|Placebo|250 mg x 3/week during a meal for a period of 2 years
16126834|NCT01959087|Procedure|single port surgery|Single port surgery can be converted in multiport surgery if necessary
16126835|NCT01959087|Procedure|Multiport surgery|
16126836|NCT01959074|Drug|Naftopidil|Naftopidil 75mg 1T qd hs
16126837|NCT01959074|Drug|Placebo for Naftopidil|Placebo 1T qd hs
16126838|NCT01959074|Drug|Standard treatment|aceclofenac 100mg on demand
16126839|NCT01959061|Drug|Raltitrexed|4mg, every 4 weeks,transhepatic arterial infusion
16126840|NCT01959061|Drug|Oxaliplatin|100~150mg, every 4 weeks, transhepatic arterial infusion
16126841|NCT01959061|Drug|lipiodol|5-20ml, every 4 weeks, hepatic artery embolization
16126842|NCT01959048|Drug|fecal microbiota transplantation|
16126843|NCT01959035|Drug|Aripiprazole once-monthly|400 or 300 mg/month; 6 intramuscular (IM) injections starting at baseline
16126844|NCT01959022|Drug|Doxazosin XL|Subjects will participate in a 2 week flexible-dose titration of doxazosin based on clinical response and adverse effects followed by 6 weeks of steady dose treatment.
16126845|NCT01959009|Other|HFOV combined with sigh breaths|"We plan only to investigate infants already ventilated on the HFOV-modus on high frequency oscillators, where the HFOV modus can be superimposed on conventional modes of ventilation. This gives the opportunity to combine HFOV with intermittent sigh breaths with a pre-set frequency and pre-set peak inspiratory pressure (PIP) and thus comparing HFOV combined with sigh breaths (HFOV-sigh) with conventional HFOV (HFOV-only).
~All included participants will be exposed to the two different ventilator strategies tested in this trial, albeit in alternating and different order.
~Each patient will serve, as it's own control. The trial will involve four alternating 1-hours periods allowing a sufficient wash-out period, as it has been shown that alveolar recruitment and derecruitment may take up to 25 min after changes to ventilator pressures At study start the patients will randomly be assigned to either starting with HFOV-only or HFOV-sigh"
16126846|NCT01958996|Drug|idarubicin|
16126847|NCT01958983|Behavioral|Music Therapy Group Session|
16126848|NCT01958970|Drug|PINTA 745|"PINTA 745 will be administered once weekly by IV infusion.
~Cohort dose schedules:
~3mg/kg weekly for 12 weeks
~3mg/kg for 3 weeks, followed by 1mg/kg for 9 weeks
~6mg/kg for 3 weeks, followed by 2mg/kg for 9 weeks"
16126849|NCT01958970|Drug|Placebo|"Placebo will be administered once weekly by IV infusion.
~Cohort dose schedules:
~3mg/kg weekly for 12 weeks
~3mg/kg for 3 weeks, followed by 1mg/kg for 9 weeks
~6mg/kg for 3 weeks, followed by 2mg/kg for 9 weeks"
16126850|NCT01958957|Drug|Ginkgolides Meglumine Injection|25mg, intravenous drip, once a day. Number of Cycles: 14 days.
16126851|NCT01958944|Drug|Nitric oxide|
16126852|NCT01958918|Drug|Ranibizumab|0.5 mg intravitreal injection
16126853|NCT01958918|Drug|Aflibercept|2 mg intravitreal injection
16126854|NCT01958905|Drug|Artemether-lumefantrine fixed combination|
16126855|NCT01958892|Procedure|TURP, TUERP|
16126856|NCT01958879|Drug|ringer with corticosteroid|200 mL Ringer solution+1mg dexamethasone after finishing the irrigation
16126857|NCT01958879|Drug|ringer without corticosteroid|200 mL Ringer solution
16126858|NCT01958866|Drug|Tinospora Crispa-extract Product|
16126859|NCT01958866|Drug|Acetaminophen|
16126860|NCT01958866|Other|Placebo|
16126861|NCT01958853|Device|RINCE|The NeuroPoint device is used to deliver repeat applications of RINCE therapy
16126862|NCT01958840|Behavioral|Behavioral Activation for Depression Treatment|
16126863|NCT01958840|Behavioral|Supportive Counseling|
16126864|NCT01958827|Biological|Adalimumab|Adalimumab pre-filled syringe, administered by subcutaneous injection.
16126865|NCT01958814|Drug|Salbutamol|First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes)
16126866|NCT01958814|Drug|Placebo|First administration of salbutamol or placebo at M0 and 2nd salbutamol or placebo at M60 (or M0 + 60 minutes)
16127163|NCT01956526|Device|CORolla™ TAA device|
16127251|NCT01955733|Drug|BI 695500|
16126867|NCT01958801|Other|Supraclavicular block|Redirection of the needle is allowed when spread of local anesthetics does not surround the brachial plexus appropriately and involuntary movement of the forearm or hand is not necessary to confirm the correct placement of the needle.
16126868|NCT01958801|Other|Interscalene block|Redirection of the needle is allowed when spread of local anesthetics does not surround the brachial plexus appropriately and involuntary movement of the forearm or hand is not necessary to confirm the correct placement of the needle.
16126869|NCT01958788|Behavioral|Cognitive-Behavioural Treatment|12 weekly sessions of individual cognitive-behavioural treatment (CBT) targeting intolerance of uncertainty.
16126870|NCT01958775|Drug|GLP-2|single subcutaneous dose of 1500mcg
16126871|NCT01958775|Drug|Placebo|
16126872|NCT01958762|Other|Invitation for oral cavity cancer screening|
16126873|NCT01958749|Procedure|Fat graft with Platelet Rich Plasma|
16126874|NCT01958736|Other|Ballistic Strength Training|The experimental group will complete jump squats on the leg sled, single leg toe push offs (or bilateral where unable to complete single), alternating legs (i.e. bounding), mini tramp jumping, progressing to jogging, quick hip flexion and bounding on land.
16126875|NCT01958736|Other|Usual Care Physiotherapy|This group will complete a suite of exercises based upon existing rehabilitation practices that aim to improve mobility after stroke. The supervising physiotherapist will select and progress the exercises, recording the performance of exercises in an exercise log and detailing incidence of adverse events. Exercise selection will include: gait retraining, cardiovascular fitness, lower limb strengthening, static and dynamic balance.
16126876|NCT01958723|Other|Hospitalists|Introduction of Problem Specific Templates
16126877|NCT01958684|Drug|Levonorgestrel IUS (Mirena, BAY86-5028)|LNG-IUS once inserted will be effective for 5 years.
16126878|NCT01958684|Device|Copper-IUD|Copper-IUD once inserted will be effective for more than 10 years.
16126879|NCT01958671|Drug|Ertugliflozin 5 mg|One tablet taken orally the same time in the morning from Day 1 through Week 52 (Phase A and Phase B).
16126880|NCT01958671|Drug|Ertugliflozin 10 mg|One tablet taken orally the same time in the morning from Day 1 through Week 52 (Phase A and Phase B).
16126881|NCT01958671|Drug|Placebo to Ertugliflozin|One placebo tablet matching the ertugliflozin 5 mg tablet and/or 1 placebo tablet matching the ertugliflozin 10 mg tablet per day taken orally the same time in the morning from Day 1 through Week 52 (Phase A and Phase B).
16126882|NCT01958671|Drug|Metformin|500 mg (1 tablet) in the morning and 500 mg (1 tablet) in the evening for 2 weeks, 1000 mg (2 tablets 500 mg) in the morning and 500 mg (1 tablet) in the evening for 2 weeks and 1000 mg (2 tablets 500 mg) in the morning and 1000 mg (2 tablets 500 mg) in the evening, thereafter.
16126883|NCT01958671|Drug|Placebo to Metformin|1 tablet in the morning and 1 tablet in the evening for 2 weeks, 2 tablets in the morning and 1 tablet in the evening for 2 weeks and 2 tablets in the morning and 2 tablets in the evening, thereafter.
16126884|NCT01958671|Drug|Glimepiride|Dosing and titration of glimepiride as rescue therapy was determined by the investigator.
16126885|NCT01958645|Drug|MEDI8111|MEDI8111 lyophilisate for solution for infusion
16126886|NCT01958645|Other|Placebo|Placebo for MEDI8111 saline solution for infusion
16126887|NCT01958632|Procedure|Nerve reconstruction|
16126888|NCT01958619|Drug|1440mg PQP tablets|Piperaquine phosphate tablets (1440mg)
16126889|NCT01958619|Drug|960mg PQP tablets|Piperaquine phosphate tablets (960mg)
16126890|NCT01958619|Drug|800mg OZ439 + TPGS|OZ439 (800mg) + TPGS granules for oral suspension
16126891|NCT01958619|Drug|960mg PQP granules|Piperaquine phosphate granules for oral solution (960mg)
16126892|NCT01958606|Other|High-intensity interval training (HIT)|Treadmill exercise using bursts of concentrated effort alternated with recovery periods
16126893|NCT01958606|Other|Traditional Aerobic Training|Moderate intensity continuous aerobic exercise on a treadmill
16126894|NCT01958593|Drug|Placebo|Placebo administered in two experimental sessions; may take part in Stage 2 upon learning condition assignment
16126895|NCT01958593|Drug|3,4-methylenedioxymethamphetamine|Participants receive full-dose MDMA during two experimental sessions; after learning their condition assignment, participants will receive a third full-dose session.
16126896|NCT01958593|Behavioral|Psychotherapy|Psychotherapy before and after experimental sessions
16126897|NCT01958580|Drug|Gemcitabine Hydrochloride|Given IV
16126898|NCT01958580|Drug|Docetaxel|Given IV
16126899|NCT01958580|Radiation|Internal Radiation Therapy|Undergo brachytherapy
16126900|NCT01958580|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16126901|NCT01958580|Radiation|External Beam Radiation Therapy|Undergo EBRT
16126902|NCT01958580|Other|Laboratory Biomarker Analysis|Correlative studies
16126903|NCT01958567|Other|Optical Coherence Tomography|
16126904|NCT01958554|Behavioral|Intervention Group|
16126905|NCT01958541|Behavioral|Sleep Intervention I|Insomnia-focused behavioral treatment (4 sessions).
16126906|NCT01958541|Behavioral|Sleep Intervention II|Insomnia-focused behavioral treatment (4 sessions).
16126907|NCT01958515|Other|research blood draw and tissue biopsy|research blood draw and tissue biopsy
16126908|NCT01958502|Genetic|surgical treatment of non union with mesenchymal stem cells with BMP2 within a 3-D tissue engineered scaffold|
16126909|NCT01958489|Drug|Evacetrapib|Administered orally
16126910|NCT01958489|Drug|Pravastatin|Administered orally
16126911|NCT01958476|Drug|Neonatal Morphine Solution|"Infants randomized to this arm will receive neonatal morphine solution (0.2mg/mL) for first line therapy. Infants will be scored using the standardized Finnegan scoring system and will be initiated on treatment if they have 2 consecutive scores greater than or equal to 8 or 1 score greater than 12. Dosing will be weight and symptom based. A double dummy design will be used - each infant will be ordered for both a methadone/placebo study drug at 0.4 mg/mL and a morphine/placebo study drug at 0.2 mg/mL. Starting doses will range from 0.3mg/kg/day to 0.9mg/kg/day divided every 4 hours depending on the severity of the Finnegan scores. Doses will be increased to a maximum of 0.9mg/kg/day for continued scores generally >8 caused primarily by worsening NAS. Infants will be weaned by 10% of the maximum dose once every 24 - 48 hours and the medication will be discontinued once at 25% of the maximum dose."
16127252|NCT01955720|Drug|BI 655075|
16127253|NCT01955720|Drug|BI 655075|
16127254|NCT01955720|Drug|Placebo|
16126912|NCT01958476|Drug|Methadone|"Infants randomized to this group will receive methadone oral solution (0.4mg/mL) for first line therapy. Infants will be scored using the standardized Finnegan scoring system and will be initiated on treatment if they have 2 consecutive scores greater than or equal to 8 or 1 score greater than or equal to 12. Dosing will be weight and symptom based. Starting doses will range from 0.3mg/kg/day to 0.9mg/kg/day divided every 8 hours depending on the severity of the Finnegan scores. To maintain blinding of the two study arms, a double dummy design will be used - each infant will receive both methadone/placebo study drug at 0.4 mg/mL and a morphine/placebo study drug at 0.2 mg/mL. Doses will be increased to a maximum of 0.9mg/kg/day for continued scores generally >8 caused primarily by worsening NAS as needed. Infants will be weaned by 10% of the maximum dose once every 24-48 hours and the medication will be discontinued once at 25% of the maximum dose."
16126913|NCT01958476|Drug|Phenobarbital|"A second line medication will be added once the infant reaches maximum doses of the study drug (morphine or methadone) for continued scores generally >8. Infants will be loaded with 20mg/kg of phenobarbital with the option to re-load with 10mg/kg q8-12 hours for 2 more doses if needed for continued high scores. Maintenance therapy of 5mg/kg/day will be initiated 12 - 24 hours after the last loading dose. Phenobarbital trough levels will be monitored with goal levels of 20 - 30 mcg/mL.
~Phenobarbital will be weaned only after the infant has been weaned off of the study drug. Weaning will begin 48 hours after the study drug has been stopped by 20% of the maximum total daily dose every 3 days for scores <8. An infant may be discharged home 48 - 72 hours after the first wean. The remaining wean will be outlined in the discharge prescription, and followed up on by study staff with the goal of the phenobarbital discontinuation within a 2 week period."
16126914|NCT01958463|Procedure|Fecal Microbiota transplantation.|Fecal Microbiota transplantation during colonoscopy.
16126915|NCT01958450|Procedure|Er:YAG laser|acne scar treatment using Er:YAG laser
16126916|NCT01958450|Procedure|Bipolar radiofrequency with diode laser|acne scar treatment with bipolar radiofrequency combined with diode laser
16126917|NCT01958437|Device|Transcranial direct current stimulation (tDCS)|Active and/or sham; All participants receive both stimulation condition. Groups will be counterbalanced (half receiving active tDCS in the first session and sham in the second session; the other half receiving the opposite).
16126918|NCT01958398|Behavioral|Promillekoll|Smartphone app monitoring alcohol use with feedback.
16126919|NCT01958398|Behavioral|PartyPlanner|Smartphone-adapted web based app for simulating an event with alcohol consumption in advance, real time monitoring alcohol use with feedback during the event and the possibility to compare these two.
16126920|NCT01958385|Device|placement of g-Cath EZ suture anchors|
16126921|NCT01958385|Procedure|Sham procedure|
16126922|NCT01958385|Behavioral|Diet and Exercise|A structured diet and exercise plan
16126923|NCT01958372|Dietary Supplement|soy isoflavones|Given PO
16126924|NCT01958372|Drug|cisplatin|Given IV
16126925|NCT01958372|Drug|etoposide|Given IV
16126926|NCT01958372|Drug|pemetrexed disodium|Given IV
16126927|NCT01958372|Radiation|radiation therapy|Undergo RT
16126928|NCT01958359|Behavioral|Short IVR|IVR-based alcohol diary with feedback
16126929|NCT01958359|Behavioral|Therapeutic IVR|IVR-based conversation offering a menu of exercises and vignettes.
16126930|NCT01958346|Other|Lingual Traction|The tongue pulling maneuver consists of grasping the tongue with 4x4cm gauze and gently pulling the tongue out until resistance is met.
16126931|NCT01958346|Other|Sham|Standard of care fiberoptic intubation without any additional experimental maneuvers
16126932|NCT01958346|Device|Fiberoptic Intubation|
16126933|NCT01958333|Procedure|Exercise 1|Low-intensity, low-volume cardiorespiratory exercise and strength training
16126934|NCT01958333|Procedure|Exercise 2|Medium-intensity, Medium-volume cardiorespiratory exercise and strength training
16126935|NCT01958333|Procedure|Exercise 3|High-intensity, High-volume cardiorespiratory exercise and strength training
16126936|NCT01958320|Other|pharmacologic treatment of the PDA|Following randomization, infants will be treated with medications used to produce PDA closure.
16126937|NCT01958320|Other|no pharmacologic treatment of the PDA|Following randomization, infants will NOT be treated with medications used to produce PDA closure (unless they develop rescue criteria at a later point in time).
16126938|NCT01958320|Drug|NSAID|Indomethacin, ibuprofen or acetaminophen will be used as standard of care treatment
16126939|NCT01958307|Behavioral|Lifestyle intervention|The intervention program consists of four individual counseling modules focusing on diet, physical activity and weight monitoring (12th-16th, 16th-20th, 30th-34th week of gestation and 6th-8th week postpartum). The counseling sessions are given by carefully trained midwives or medical staff in combination with prenatal visits and follow a standardized curriculum. Women are provided with brochures including a list of adequate prenatal exercise programs and a pedometer. Furthermore, they receive a chart personalized according to their baseline BMI category to monitor weight development.
16126940|NCT01958294|Device|MICHI Neuroprotection System|
16126941|NCT01958281|Drug|SOF|Tablet(s) administered orally once daily
16126942|NCT01958281|Drug|RBV|200 mg tablet administered orally once daily
16126943|NCT01958281|Drug|LDV/SOF|90/400 mg fixed-dose combination (FDC) tablet administered orally once daily
16126944|NCT01958268|Procedure|Pretest and validation of a translated questionnaire|
16126945|NCT01958255|Behavioral|planned intervention for tobacco cessation counseling|game session for rapport building followed by group discussion and tobacco cessation counseling
16126946|NCT01958242|Other|Preoperative blood harvesting|There is no true intervention, there is a protocol of preoperative blood harvesting ,and post operative administration of the same blood/
16126947|NCT01958216|Other|Intravenous injection of deuterated cholesterol diluted in intralipid 20%|At day 0, bile diverted patients will receive an intravenous injection of deuterated cholesterol diluted in intralipid 20%. The plasma, biliary and fecal content of deuterated cholesterol will be measured, by mass spectrometry, at 24, 48 and 72 hours after the initial input.
16126995|NCT01957865|Device|Triggered SMS, real-time monitoring|SMS reminders will be sent as needed for missed doses to encourage adherence. The Wisepill system will automatically capture and report each time the device is opened as a proxy for the participant's adherence.
16126996|NCT01957852|Other|FloSeal|
16126997|NCT01957839|Drug|cabergoline treatment|cabergoline treatment for hyperprolactinemia group
16126948|NCT01958190|Drug|Tacrolimus and Sirolimus|"Arm 1 once daily combination therapy of normal dosed extended-release tacrolimus and prednisone for 3 months and monotherapy once daily extended-release tacrolimus thereafter up to 3 years after liver transplantation.
~Arm 2 once daily combination therapy of low doses sirolimus and extended-release tacrolimus and prednisone for 3 months and combination therapy of low dose sirolimus and extended-release tacrolimus thereafter for up to 3 years after liver transplantation Continue Advagraf (5-10 ng/ml) and 7.5 mg prednison; lower or discontinue steroids after day 180 at the discretion of the treating physician Conversion to sirolimus (3-5 ng/ml) and decrease Advagraf (3-5 ng/ml); 7.5 mg prednisone and lower or discontinue steroids after day 180 at the discretion of the treating physician"
16126949|NCT01958190|Drug|Tacrolimus|Patient received standard-dose of Tracrolimus Advagraf (5-10 ng/ml) and 7.5 mg prednison; lower or discontinue steroids after day 180 at the discretion of the treating physician
16126950|NCT01958177|Biological|Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)|Total 3 doses ,in 30 days ,in 7days interval Intravenous transfer of of Bone Marrow derived Mono Nuclear Stem Cell BMMNCs)
16126951|NCT01958164|Drug|Actilyse|Actilyse 2mg/2ml will be given if the CVAD has not been restored at time 120min.
16126952|NCT01958164|Drug|Saline solution|Instil Saline solution 2 ml into the disfunctional CVAD once at time O only for patients enrolled in Group II
16126953|NCT01958164|Drug|Actilyse|Instil Actilyse 2 mg/ 2 ml into the dysfunctional CVAD at time O.
16126954|NCT01958164|Drug|Actilyse|Second dose of Actilyse 2mg/2ml will be given if CVAD has not been restored at time 120min.
16126955|NCT01958151|Other|State-Trait Anxiety Inventory Scores|Patients are evaluated before the procedure with State-Trait Anxiety Inventory scores to determine the anxiety level.
16126956|NCT01958138|Drug|comparison of group-I (low dose propofol with isoflurane)|Prior to LMA removal in group-I, isoflurane MAC awake (MAC less than 0.5) will be achieved in expiratory gases with 60% nitrous oxide and 40% oxygen. Propofol 1 mg/Kg will be combined with Isoflurane MAC awake and LMA will be removed after 20 seconds of propofol administration in group-I. The group-II LMA will be removed at end expiratory isoflurane MAC of 1.2% with 60% nitrous oxide and 40% oxygen
16126957|NCT01958125|Device|gammaCore|Vagal stimulation
16126958|NCT01958112|Drug|GSK1120212 (trametinib)|Trametinib dose is 1.5 mg orally once per day
16126959|NCT01958112|Drug|GSK2141795|The dose of GSK2141795 is 50 mg orally once per day
16126960|NCT01958099|Behavioral|Education|
16126961|NCT01958086|Device|Neural Communication System|NeuroPort Arrays allow for the local recording of cerebral cortex. Key features include sterile, single use electrodes that provide access to a localized population of individual cells. The Neural Communication system is primarily composed of two NeuroPort Multi-Port Arrays. The main component of the NeuroPort Multi-Port Array are 2 arrays comprised of 100 microelectrodes (1.5 mm in length) uniformly organized on a 4 mm x 4 mm silicon base that is 0.25 mm thick. Each microelectrode is insulated with Parylene-C polymer and has a platinum tip that is 100-200 microns in length. The Patient Pedestal is made from titanium and is 19 mm wide at the skin interface.
16126962|NCT01958073|Drug|Conjugated Estrogen Vaginal Cream|
16126963|NCT01958073|Drug|Estradiol Ring|
16126964|NCT01958073|Drug|Placebo|
16126965|NCT01958060|Drug|BI 1034020|intravenous part
16126966|NCT01958060|Drug|Placebo to BI 1034020|intravenous part
16126967|NCT01958047|Drug|ASP3652|Oral
16126968|NCT01958034|Dietary Supplement|Bilberry extract|
16126972|NCT01958008|Drug|Placebo to BI 113608 high dose b.i.d.|Film-coated tablet
16126973|NCT01958008|Drug|Placebo to BI 113608 low dose b.i.d.|Film-coated tablet
16126974|NCT01958008|Drug|BI 113608 high dose b.i.d.|Film-coated tablet
16126975|NCT01958008|Drug|Placebo to BI 113608 medium dose b.i.d.|Film-coated tablet
16126976|NCT01958008|Drug|BI 113608 low dose b.i.d.|Film-coated tablet
16126977|NCT01958008|Drug|BI 113608 medium dose b.i.d.|Film-coated tablet
16126978|NCT01957995|Drug|nanosomal docetaxel lipid suspension|Given IV
16126979|NCT01957995|Other|pharmacological study|Correlative studies
16126980|NCT01957969|Device|Sacral Nerve Stimulation|
16126981|NCT01957956|Other|Laboratory Biomarker Analysis|Correlative studies
16126982|NCT01957956|Biological|Malignant Glioma Tumor Lysate-Pulsed Autologous Dendritic Cell Vaccine|Given ID
16126983|NCT01957956|Drug|Temozolomide|Given PO
16126984|NCT01957943|Dietary Supplement|SMOFLipid|
16126985|NCT01957943|Dietary Supplement|equivalent volume of 10% glucose solution|Patients will receive same dose of 10% glucose solution for 2 days pre operatives and 5 days post-operative
16126986|NCT01957930|Drug|Intensified insulin treatment|The treatment regimen of the intensified treatment group consisted of individual education and then continuous tutoring with frequent face-to-face and telephone contact.
16126987|NCT01957930|Drug|Standard treatment|Patients continuing with routine diabetes care (insulin treatment), visiting physician every four months
16126988|NCT01957917|Other|NAC (Nutritional Assessment and Counseling)|
16126989|NCT01957917|Other|Cash Transfer|
16126990|NCT01957917|Other|Food Assistance|
16126991|NCT01957904|Device|ArterX Surgical Sealant|
16126992|NCT01957878|Biological|ProCervix|ProCervix consists of two recombinant adenylate cyclase (CyaA) proteins, CyaA-HPV 16E7 (C16-1) and CyaA-HPV 18E7 (C18-1) in a 50/50 ratio (C16C18-2 Ag mixture). ProCervix is adjuvanted by Aldara™, a cream containing 5% of imiquimod
16126993|NCT01957878|Biological|Placebo|Placebo matching ProCervix and adjuvanted by Aldara™, a cream containing 5% of imiquimod
16126994|NCT01957865|Device|Fixed SMS, real-time monitoring|SMS reminders will be sent daily for one month, then weekly for two months, then as needed for missed doses to encourage adherence. The Wisepill system will automatically capture and report each time the device is opened as a proxy for the participant's adherence.
16126998|NCT01957826|Other|bone marrow-derived MSCs injection|transendocardial injection of 30-40 million bone marrow-derived MSCs with the NOGA XPTM platform. 15 injections in the anterior wall of the left ventricle.
16127000|NCT01957813|Behavioral|Lifestyle Counseling|"Peer educators will be trained using existing materials to deliver accurate messaging on FP/dual method use, during individual encounters and in group sessions.
~Screening for unmet FP need in DICs Providing job aids to FP counselors Expanding FP methods with intra-uterine contraceptive devices (IUCD) and implants Time change in DIC hours of operation"
16127001|NCT01957813|Other|Standard Health Services|Peer education and health services
16127002|NCT01957800|Behavioral|Website|Website will have action planning with social interactions and support features for sharing, reusing, and recommending strategies for improving habits.
16127003|NCT01957800|Behavioral|Usual Care|Participants will record their weight and complete surveys online.
16127004|NCT01957787|Device|Cryoablation|Application of extremely cold temperatures to the identified tumor(s).
16127005|NCT01957774|Drug|THR-18|THR-18 is an 18-mer peptide derived from the sequence of human plasminogen activator inhibitor 1 (PAI-1), having the ability to bind to a site of tissue plasminogen activator (tPA) distal to its catalytic site and uncouple the beneficial clot-dissolving properties of tPA from its deleterious non-fibrinolytic effects.
16127006|NCT01957774|Drug|Placebo|
16127007|NCT01957748|Behavioral|SoC + ALERT Intervention|Enhanced retention efforts and education modules will be implemented by the ALERT Specialist to ensure retention to care.
16127008|NCT01957735|Drug|BP31510 monotherapy|
16127009|NCT01957735|Drug|BP31510 in combination with chemotherapy|
16127010|NCT01957722|Procedure|Microfracture|Surgical procedure which creates a marrow clot in the prepare cartilage defect.
16127011|NCT01957722|Biological|NOVOCART 3D|combination product- biologic (autologous chondrocytes) /device (scaffold) implant
16127012|NCT01957709|Other|Laboratory Biomarker Analysis|Correlative studies
16127013|NCT01957709|Biological|Recombinant Interferon Gamma|Given subcutaneously weekly for four weeks prior to surgery.
16127014|NCT01957683|Device|eCLIPs™ Family of Products|Safety and feasibility of the eCLIPs™ Family of Products for the treatment of unruptured bifurcation intracranial aneurysms
16127015|NCT01957670|Device|Lacrima medical Prototypes|
16127016|NCT01957657|Drug|BI 207127|oral administration
16127017|NCT01957657|Drug|faldaprevir|oral administration
16127018|NCT01957657|Drug|BI 207127|oral administration
16127019|NCT01957657|Drug|BI 207127|oral administration
16127020|NCT01957657|Drug|BI 207127|oral administration
16127021|NCT01957657|Drug|faldaprevir|oral administration
16127022|NCT01957657|Drug|faldaprevir|oral administration
16127023|NCT01957657|Drug|faldaprevir|oral administration
16127024|NCT01957644|Drug|Azacitidine|
16127025|NCT01957644|Drug|Volasertib|
16127026|NCT01957631|Drug|Corticosteroid injection (Bupivacaine and Depo Medrol)|The use of corticosteroid injections to treat heel pain has been a relatively common practice. They are mainly used in conjunction with other modes of conservative therapies. With a 10cc syringe, 3 mL of 0.5% Bupivacaine and 2 mL of 80mg Depo Medrol are injected into the medial calcaneal tubercle using an aseptic technique.
16127027|NCT01957631|Biological|Platelet rich plasma injection|10-15cc of patient's blood is drawn and centrifuged in a Rotofix 32A at 1500 cycles/minute for 5 minutes to separate the platelets from the other components of blood. 4-6cc of concentrated platelets are then re-injected into the medial calcaneal tuberosity using an aseptic technique. Sterile techniques are very important in this procedure to decrease the risk of infection.
16127028|NCT01957592|Other|No treatment given|Patients will fill out a questionnaire by interview.
16127029|NCT01957579|Drug|MEDI-551|MEDI-551 will be administered by intravenous infusion at dose of 2, 4 or 8 mg/kg once per week on Days 1 and 8 in the first cycle and then once every 28 days at the start of each subsequent cycle
16127030|NCT01957566|Procedure|APS|
16127031|NCT01957553|Device|Coloplast test product|Coloplast test product is a newly developed 2-piece ostomy appliance
16127032|NCT01957553|Device|SenSura|SenSura is the commercial available CE-marked SenSura Click 2-piece ostomy appliance from Coloplast A/S
16127033|NCT01957540|Drug|Ticagrelor|
16127034|NCT01957540|Drug|Prasugrel|
16127035|NCT01957527|Device|Peripheral arterial tonometry (EndoPAT)|
16127036|NCT01957514|Other|Cytology Specimen Collection Procedure|Undergo tissue biopsy, blood, buccal mucosa, saliva, and urine collection
16127037|NCT01957514|Other|Laboratory Biomarker Analysis|Correlative studies
16127038|NCT01957514|Other|Quality-of-Life Assessment|Ancillary studies
16127039|NCT01957514|Other|Questionnaire Administration|Ancillary studies
16127040|NCT01957501|Other|MDDScoreTM|The child will receive a single blood draw (about 10 mL).
16127041|NCT01957488|Device|Coloplast Test Product 1|Coloplast Test product 1 is a newly developed 1-piece ostomy appliance
16127042|NCT01957488|Device|Coloplast Test Product 2|Coloplast Test product 2 is a newly developed 1-piece ostomy appliance
16127043|NCT01957488|Device|Coloplast SenSura|SenSura 1-piece is the commercial available CE-marked SenSura 1-piece from Coloplast A/S.
16127044|NCT01957475|Device|Coloplast Test product Y|Coloplast Test product Y is a newly developed 2-piece convex ostomy appliance
16127045|NCT01957475|Device|Coloplast Test product Z|Coloplast Test product Z is a newly developed 2-piece convex ostomy appliance
16127046|NCT01957462|Device|Coloplast Test V|Coloplast Test product V is a newly developed 1-piece ostomy appliance
16127047|NCT01957462|Device|Coloplast Test X|Coloplast Test X is a newly developed 1-piece ostomy appliance
16127048|NCT01957449|Drug|Propranolol|Propranolol by mouth given daily throughout hospitalization for up to 12 months
16127049|NCT01957449|Drug|Placebo|Placebo by mouth given daily throughout hospitalization for up to 12 months.
16127050|NCT01957436|Drug|abiraterone acetate|abiraterone 1000mg/day (4 tablets of 250 mg (PO) per day) + prednisone 5mg bid
16127051|NCT01957436|Radiation|radiotherapy|74 Gy in 37 fractions 3D-Conformal RT or Intensity Modulated RT (IMRT)
16127052|NCT01957436|Other|Androgen Deprivation Therapy|The ADT must consist in either LHRH agonist, LHRH antagonist or orchiectomy
16127053|NCT01957436|Drug|Docetaxel|6 cycles at 75mg/m²/cycle, one cycle every 3 weeks
16127164|NCT01956513|Other|MRI (Magnetic resonance imaging)|MRI will be realised at the beginning of the study, after a cycle of chemotherapy or at changement of sequence and at the end of chemotherapy.
16127255|NCT01955720|Drug|BI 655075|
16127054|NCT01957423|Dietary Supplement|Whey protein|Whey protein was provided as sachets with 15g. Patients were advised to consume two sachets per day (amounting to 22.4g of protein) mixed with food or a cold beverage, for 16 weeks. All patients remained on an unrestricted diet and did not receive nutritional advice.
16127055|NCT01957423|Dietary Supplement|Soy protein|Soy protein was provided as sachets with 15g. Patients were advised to consume two sachets per day (amounting to 22.4g of protein) mixed with food or a cold beverage, for 16 weeks. All patients remained on an unrestricted diet and did not receive nutritional advice.
16127056|NCT01957410|Drug|Ketamine|During Cohorts 1 and 2, a single ketamine 0.5 mg/kg dose will be given as a continuous IV infusion over 40 minutes by use of an electronic syringe infusion pump. The predefined dose and infusion rate/duration should not be adjusted. If a patient is unable to tolerate the study medication, the infusion should be stopped. Within 1 week of completion of the open-label treatment phase, participants can receive a single dose of ketamine 0.5 mg/kg administered as an IV infusion over 40 minutes during an optional open-label treatment phase.
16127057|NCT01957410|Drug|Placebo|During Cohort 2, a single placebo dose will be given as a continuous IV infusion over 40 minutes by use of an electronic syringe infusion pump. Within 1 week of completion of the double-blind treatment phase, participants can receive a single dose of ketamine 0.5 mg/kg administered as an IV infusion over 40 minutes during an optional open-label treatment phase.
16127058|NCT01957397|Device|Coloplast Test 1|Coloplast Test 1 is a newly developed 2-piece convex ostomy appliance
16127059|NCT01957397|Device|Coloplast Test 2|Coloplast Test 2 is a newly developed 2-piece convex ostomy appliance
16127060|NCT01957397|Device|Coloplast Test 3|Coloplast Test 3 is a newly developed 2-piece convex ostomy appliance
16127061|NCT01957384|Device|Coloplast Test product 1|Coloplast Test product 1 is a new ostomy appliance developed by Coloplast.
16127062|NCT01957384|Device|Coloplast Test product 2|Coloplast Test product 2 is a new ostmoy appliance developed by Coloplast A/S
16127063|NCT01957384|Device|Standard Care (Coloplast SenSura; Dansac Nova 1; Hollister Moderma FLex; Convatec Esteem; B.Braun Flexima Active)|"Standard Care was the subject usual ostomy appliance and had to be one of the following:
~Coloplast: SenSura, 1-piece open bag without inspection window, size midi and maxi, custom-cut,
~Dansac: Nova 1 & Nova Life, 1-piece open bag, size midi and maxi, custom-cut baseplate
~Hollister: Moderma Flex, 1-piece open, size midi and maxi, custom-cut baseplate
~ConvaTec: Esteem, 1-piece open bag, size midi and maxi, custom-cut baseplate
~B. Braun: Flexima Active & Softima, 1-piece open bag, size midi and maxi, custom-cut baseplate"
16127064|NCT01957371|Behavioral|Mindful Yoga Therapy|Veterans will participate in twice weekly Mindful Yoga Therapy, which includes meditation, breathing practices, physical postures/movements, and guided rest (yoga nidra), as well as daily home practice.
16127065|NCT01957358|Behavioral|The Grief Recovery Method|The Grief Recovery Method is a structured process designed to help people with spinal cord injuries examine their knowledge of their injury, their emotional reaction to their injury, and their ability to acknowledge their grief over the injury in order to learn techniques to resolve the grief in order to achieve a more complete recovery. Participants will attend a total of 18 sessions, some one-on-one, and some in a group setting. The Grief Recovery Handbook, handouts, DVD (digital video disc) presentations and questionnaires will be used. Targeted activities to decrease isolation and assist volunteers to identify goals for recovery will be utilized.
16127066|NCT01957345|Other|Blood punction|"T1 and T2: one blood punction with signalisation test (T1 for each arm, T2 at +6 months only if an anomaly at signalisation test is detected)
~signalisation test is made by flow cytometry
~Stage 1: for arm bleeding disorder : flow cytometry analysis to establish reference values observed in subjects without thrombopathy for each marker after agonist stimulation and corresponding search of an effect if a center-center effect is observed on the reference values its origin will be sought and corrected.
~Stage 2: for the two others arms: Several markers will be analyzed, corresponding to routes or levels of different signaling. For each of these markers, the test will evaluate quantitatively the phosphorylation activity of the protein tested."
16127067|NCT01957332|Procedure|Molecular imaging|On the day of FES-injection&scan or the day after FES-injection, 89Zr-trastuzumab (~37 MBq) will be injected. The HER2-PET will be performed 4 days after tracerinjection.
16127068|NCT01957332|Procedure|Molecular imaging|All patients receive 18F-FES (~200MBq) injection followed by a FES-PET.
16127069|NCT01957319|Drug|Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg|
16127070|NCT01957319|Drug|sugar pill|
16127071|NCT01957306|Dietary Supplement|Dr. Tagliaferri's Menopause Formula|Administered as 2 grams PO BID
16127072|NCT01957293|Drug|Salbutamol|single oral administration, 4 mg
16127073|NCT01957293|Drug|Placebo|single oral administration
16127074|NCT01957280|Drug|patritumab|
16127075|NCT01957228|Procedure|bone biopsies|
16127076|NCT01957215|Drug|Indomethacin|Topical indomethacin
16127077|NCT01957215|Drug|Placebo|Placebo patch
16127078|NCT01957202|Drug|FF/levocabastine|FF/levocabastine (25mcg/50 mcg) will be supplied as intranasal aqueous microsuspension in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension. Two sprays in each nostril in the morning in a fasted state will be administered.
16127079|NCT01957202|Drug|FF|FF (25mcg) will be supplied as intranasal aqueous microsuspension in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension. Two sprays in each nostril in the morning in a fasted state will be administered.
16127080|NCT01957202|Drug|levocabastine|levocabastine (50mcg) will be supplied as intranasal aqueous microsuspension in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension. Two sprays in each nostril in the morning in a fasted state will be administered.
16127081|NCT01957202|Drug|Placebo|Placebo will be supplied as intranasal aqueous microsuspension in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension. Two sprays in each nostril in the morning in a fasted state will be administered.
16127082|NCT01957189|Drug|Dutasteride and Tamsulosin|0.5mg dutasteride once a day on Day 1 Period A , and Day 5 Period C,0.2mg Tamsulosin once a day on Day 1 to Day 7 in Period B and Period C
16127246|NCT01955785|Device|Pressure Regulated Volume Controlled Ventilator|
16127247|NCT01955772|Drug|Enteral nutrition alanyl-glutamin, Dipeptiven|Enteral nutrition versus parenteral nutrition
16127256|NCT01955720|Drug|Placebo|
16127083|NCT01957176|Drug|ELT|Subjects will be dosed with ELT tablets or powder for oral suspension (PfOS) based on the dosage form used in the parent study. ELT tablets will be white, round film coated tablets containing ELT olamine equivalent to 12.5 mg, 25 mg, 50 mg, 75 mg and 100 mg of ELT. ELT PfOS is a reddish-brown to yellow powder contained inside an elongated sachet. Each sachet will contain ELT olamine equivalent to 20 mg of ELT per gram of powder.
16127084|NCT01957163|Drug|FF|Dry white powder containing 100mcg of Fluticasone Furoate blended with lactose per blister was administered by DPI.
16127085|NCT01957163|Drug|VI|Dry white powder containing 25mcg of Vilanterol micronised drug (as the 'M' salt triphenylacetate) blended with lactose and magnesium stearate per blister was administered by DPI.
16127086|NCT01957163|Drug|UMEC|Umeclidinium bromide in a powder blend with lactose and magnesium stearate was used at two different doses 62.5mcg and 125mcg.
16127087|NCT01957163|Drug|Placebo|The matching placebo DPI identical in appearance to the inhaler containing active study medication.
16127088|NCT01957150|Drug|Fluticasone Furoate/Vilanterol|Dry white powder containing 100 mcg of Fluticasone Furoate blended with lactose per blister was administered by NDPI. Dry white powder containing 25 mcg of Vilanterol micronised drug (as the 'M' salt triphenylacetate) blended with lactose and magnesium stearate per blister was administered by NDPI.
16127089|NCT01957150|Drug|Vilanterol|Dry white powder containing 25 mcg of Vilanterol micronised drug (as the 'M' salt triphenylacetate) blended with lactose and magnesium stearate per blister was administered by NDPI.
16127090|NCT01957137|Device|InterStim® (Device Programming)|
16127091|NCT01957124|Procedure|PRF (Platelet-Rich Fibrin)|
16127092|NCT01957098|Dietary Supplement|Placebo comparator: 0% pentose|14 healthy subjects participated in a randomized double-blinded cross-over study based on four single tests. Sucrose containing drinks were supplemented with two different doses of D-xylose and in addition one dose of L-arabinose was included for comparison with earlier studies. Blood was collected fasting and for 3-h postprandially. Appetite sensations and energy intake were registered. Gastrointestinal symptoms were monitored for 24 hours
16127093|NCT01957098|Dietary Supplement|Active comparator: 4% D-xylose|
16127094|NCT01957098|Dietary Supplement|Active comparator: 8% D-xylose|
16127095|NCT01957098|Dietary Supplement|Active comparator: 8% L-arabinose|
16127096|NCT01957085|Other|observation only|This is an observational only, nonintervention study. There will be no patient contact. This was a de-identified point prevalence study of hepatitis C infection in hospitalized patients in an inner city hospital.
16127097|NCT01957072|Behavioral|Behaviour change intervention|"The behaviour change intervention consists of
~feedback via a web-based food diary
~'coaching' with problem-solving and implementation plans
~The intensive intervention phase consists of 2 home visits, 8 telephone calls and 6 reminder emails.
~The maintenance phase consists of 3 telephone calls and 4 reminder emails."
16127098|NCT01957059|Drug|Regimen Selection Phase Group 2|"All doses of BMN053 will be administered as IV infusions. The proposed doses are as follows:
~• 3 mg/kg"
16127099|NCT01957059|Drug|Regimen Selection Phase Group 3|"All doses of BMN053 will be administered as IV infusions. The proposed doses are as follows:
~• 4-6 mg/kg"
16127100|NCT01957059|Drug|Treatment Phase Group 4|All doses of PRO053 will be administered as IV infusions. The proposed doses will be decided upon completion of the Regimen Selection Phase of Groups 2 and 3
16127101|NCT01957059|Drug|Regimen Selection Phase Group 1 (COMPLETED)|All doses of BMN053 have been administered as subcutaneous injections.
16127102|NCT01957059|Drug|Dosing Extension|All doses of PRO053 will be administered as IV infusions. The proposed doses will be decided upon completion of the Regimen Selection Phase of Groups 2 and 3 and the Treatment Phase Group 4.
16127103|NCT01957046|Drug|Laxative|
16127104|NCT01957033|Behavioral|Exercise and education once/week for 6 weeks|Exercises will include specific range of motion, strengthening, and motor control exercises for the neck and shoulder girdle. Education will include prognosis information, advice to stay active, and use of a book
16127105|NCT01957033|Behavioral|Exercise and education twice/week for 6 weeks|Exercises will include specific range of motion, strengthening, and motor control exercises for the neck and shoulder girdle. Education will include prognosis information, advice to stay active, and use of a book about whiplash.
16127106|NCT01957033|Behavioral|Exercise and education 3 times/week for 6 weeks|Exercises will include specific range of motion, strengthening, and motor control exercises for the neck and shoulder girdle. Education will include prognosis information, advice to stay active, and use of a book about whiplash.
16127107|NCT01957033|Other|Manual therapy once/week for 3 weeks|Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
16127108|NCT01957033|Other|Manual therapy twice/week for 3 weeks|Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
16127109|NCT01957033|Other|Manual therapy 3 times/week for 3 weeks|Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
16127110|NCT01957033|Other|Manual therapy once/week for 6 weeks|Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
16127111|NCT01957033|Other|Manual therapy twice/week for 6 weeks|Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
16127112|NCT01957033|Other|Manual therapy 3 times/week for 6 weeks|Manual therapy will consist of low velocity mobilizations of the cervical and upper thoracic spine based on the findings of the treating physiotherapist.
16127113|NCT01957007|Drug|Docetaxel|Docetaxel will be administered IV.
16127114|NCT01957007|Drug|vantictumab|Vantictumab will be administered intravenously
16127115|NCT01956994|Dietary Supplement|Whey protein supplement|Supplements will be provided in powder form and mixed into beverages to be consumed twice per day (after breakfast and after dinner).
16127116|NCT01956994|Dietary Supplement|Carbohydrate supplement|Supplements will be provided in powder form and mixed into beverages to be consumed twice per day (after breakfast and after dinner).
16127248|NCT01955759|Drug|Amiodarone tab 200 mg x 3|starting 7 days before coronary by-pass surgery per os 200 mg. x 3 tab, followed by 200 mg x 2 tab per os starting on the second postoperative day untill discharge
16127117|NCT01956981|Drug|Magnesium Sulfate|40 mg kg-1 IV magnesium sulfate (OSEL ilaç San. Ve Tic. A.Ş., Beykoz, Istanbul, Turkey) in 100 ml saline solution was applied to patients in Group M as a loading dose 10 minutes before the induction and continued during the surgery at the dose of 10-15 mg kg-1hour-1.
16127118|NCT01956981|Drug|Dexmedetomidine|1 µg kg-1 IV dexmedetomidine (Precedex Abbott Labs, North Chicago, IL) in 100 ml saline solution was applied to patients in group D 10 minutes before the surgery and continued during the surgery at the dose of 0.5-1 µg kg-1.
16127119|NCT01956955|Drug|enoxaparin ,alteplase, unfractionated heparin|
16127120|NCT01956942|Device|Micropulse Laser Trabeculoplasty|
16127121|NCT01956942|Device|Selective Laser Trabeculoplasty|
16127122|NCT01956929|Drug|Metformin|Metformin 1000mg daily for one week, then 2000 mg daily for the second week. 4 week washout period, then crossover to placebo.
16127123|NCT01956929|Drug|Placebo|Placebo tablets for 2 weeks, then 4 weeks of washout period, then crossover to metformin.
16127124|NCT01956916|Dietary Supplement|Lactobacillus rhamnosus GG|"Capsules containing lyophilized 6x10^9 Colony Forming Units (CFU)/die LGG, (60mg) maltodextrin (163 mg), gelatine capsule (75 mg), magnesium stearate (2 mg)
~1 cps/die for 12 months"
16127125|NCT01956916|Dietary Supplement|placebo|"Capsules containing maltodextrin (163 mg), gelatine capsule (75 mg), magnesium stearate (2 mg)
~1 cps/die for 12 months"
16127126|NCT01956903|Genetic|Allogenic Mesenchymal Stem Cell|"Expanded in-Vitro Allogenic Mesenchymal Stem Cell (authorized by Spain, Agencia Española de Medicamentos y Productos Sanitarios with number 06-076)"
16127127|NCT01956890|Drug|PET|18F-FLT PET and MRI of the breast
16127128|NCT01956864|Drug|Vitamin D|Doses of vitamin D will be increased from a baseline dose to the maximum tolerated dose. There could therefore be up to 5 possible doses of Vitamin D. Once the maximum tolerated dose of vitamin D has been determined, patients will follow a regimen on that dose for 6 months.
16127129|NCT01956838|Dietary Supplement|umami|intraduodenal infusion of umami tastant
16127130|NCT01956838|Dietary Supplement|bitter|intraduodenal infusion of bitter tastant
16127131|NCT01956838|Dietary Supplement|sweet|intraduodenal infusion of sweet tastant
16127132|NCT01956825|Dietary Supplement|"slim water"|
16127133|NCT01956812|Drug|IMMU-107|Arm A: gemcitabine 200 mg/m2 administered weekly x 4 and IMMU-107 administered weekly x 3 for multiple cycles
16127134|NCT01956812|Drug|placebo|placebo weekly x 3 and gemcitabine 200 mg/m2 weekly x 4 for multiple cycles
16127135|NCT01956812|Drug|Gemcitabine|Gemcitabine, 200 mg/m2, given weekly x 4 in both arms
16127136|NCT01956786|Drug|Amlodipine-FA tablet,low dose group|5mg amlodipine combined with 0.4mg folic acid,once daily (Low-dose group)
16127137|NCT01956786|Drug|Amlodipine-FA tablet,high dose group|5mg amlodipine combined with 0.8mg folic acid,once daily (High-dose group)
16127138|NCT01956786|Drug|Amlodipine|5mg amlodipine,once daily
16127139|NCT01956773|Other|MeTree|Software program collecting family health history and generating clinical decision support for risk-based preventive care
16127140|NCT01956760|Other|Acupuncture and intradermal acupuncture|The acupuncture was applied at 5 acupoints(HT7 Shenmen, PC6 Neiguan, SP6 Sanyinjiao, KI6 Zhaohai, BL62 Shenmai) 3 times in a week. It was performed by a certified practitioner with sterile needles (0.25*40.0mm). The needles were inserted at least 10.0mm deep through the skin and maintained for 20 minutes The intradermal acupuncture was applied at the same acupoints, immediately after the acupuncture needles were removed. It was performed by the same practitioner with sterile needles (0.20*8.0mm).attached to skin tape (10.0*10.0mm). The needles were inserted 3.0~5.0mm deep and maintained for 48~72 hours
16127141|NCT01956747|Procedure|venapunction|
16127142|NCT01956747|Procedure|bone marrow punction|
16127143|NCT01956734|Procedure|DNX2401 and Temozolomide|"Virus injection in the brain parenchyma after pathology confirmation of recurrent glioblastoma.
~Temozolomide oral 14 days after virus injection."
16127144|NCT01956721|Procedure|Exercise training,|
16127145|NCT01956721|Procedure|Muscle biopsy|
16127147|NCT01956695|Drug|Lenalidomide|
16127148|NCT01956695|Drug|Rituximab|
16127149|NCT01956682|Dietary Supplement|HA formula + starch + L. reuteri|
16127150|NCT01956669|Drug|Pazopanib|Pazopanib was supplied as a series of aqueous film-coated tablets containing 200 mg (oval-shaped, white, packaged in bottles containing 34 tablets each), and 400 mg (oval-shaped, white, packaged in bottles containing 68 tablets each). Pazopanib Powder for Oral Suspension was a white to slightly colour powder supplied to the clinical sites in amber glass (United State Pharmacopeia (USP) Type III) bottles with child-resistant closures. Each bottle contains 5 g of pazopanib.
16127151|NCT01956656|Drug|lotus leaf mouthwash|Saline mouthwash to be used for 4 days twice daily by one group the other group the lotus leaf mouthwash
16127152|NCT01956643|Other|gum chewing|gum chewing
16127153|NCT01956643|Other|Control|Routine care during NPO
16127154|NCT01956630|Biological|Genetically modified DCs plus CIK cells|
16127155|NCT01956630|Biological|Donor leukocyte infusions (DLI)|
16127156|NCT01956617|Other|lumbar plexus block|
16127157|NCT01956604|Drug|Clonidine|
16127158|NCT01956604|Drug|Placebo|
16127159|NCT01956591|Drug|Oxybutynin|All patients are treated with oxybutynin for hyperhidrosis. Usual maintenance dose is 10mg/day, but dose may vary according to weight, efficacy and side effects. Our standard protocol starts with 2.5mg/day in the first 7 days, progresses to 5mg/day for 14 days and then reaches the usual maintenance dose of 10mg/day afterwards.
16127160|NCT01956578|Other|Breathing Exercise Cohort|All patients enrolled will be asked to wear a respiration band and perform a series of breathing exercises.
16127161|NCT01956565|Other|Inspiratory Muscle training|Participants will perform 8 weeks of IMT strength training using the Powerbreathe Kinetic device (Powerbreathe). Training will progress to 60% maximum inspiratory pressure (PiMax) with 30 breaths at high velocity (paced initially over a period of 15 minutes), twice a day, 5 days per week. Tidal breathing without inspiratory resistance is acceptable for recovery between each high velocity breath. Training will be titrated and supervised weekly for the first 8 weeks by a physiotherapist. After 8 weeks training the participants are advised to continue training unsupervised, twice a day, 3 times per week for a further 18 weeks.
16127162|NCT01956552|Other|biopsy or cytopuncture|
16127165|NCT01956500|Dietary Supplement|Instaflex|The Instaflex supplement contained the following ingredients (in 3 capsules): Glucosamine sulfate (1500 mg), methylsulfonylmethane (MSM) (500 mg), white willow bark extract (standardized to 15% salicin) (250 mg), ginger root concentrate (50 mg), boswella serrata extract (standardized to 65% boswellic acid) (125 mg), turmeric root extract (50 mg), cayenne 40m H.U. (50 mg), and hyaluronic acid (4.0 mg).
16127166|NCT01956500|Dietary Supplement|Placebo|The placebo capsules will contain magnesium stearate, an inert substance.
16127167|NCT01956487|Drug|Propafenone|Comparison of drug from 2 manufacturing sites
16127168|NCT01956474|Other|Theralight crosslinking and Riboflavin|Corneal Collagen cross linking with UV light and riboflavin
16127169|NCT01956448|Device|Drug eluting stent|Device: Percutaneous intervention with implantation of drug eluting coronary stent (Resolute Integrity)
16127170|NCT01956435|Device|Excimer Light Treatment|Excimer light treatment will be performed on one leg of every subject as the intervention while the subjects other leg will serve as a control
16127171|NCT01956422|Device|Continuous Positive Airway Pressure(CPAP)|
16127172|NCT01956422|Device|Venturi Mask FiO2 40%|
16127173|NCT01956409|Drug|18F-FCH|
16127174|NCT01956409|Drug|Magnevist|
16127175|NCT01956396|Device|PrePex™ device|PrePex™ device for adult male circumcision. The non-surgical PrePex™ device with No Injected Anesthesia
16127176|NCT01956383|Device|PrePex™ device|PrePex™ device for adult male circumcision. The PrePex™ device facilitates adult male circumcision that is bloodless with no anesthesia and no sutures
16127177|NCT01956370|Device|PrePex™ device for adult male circumcision|The PrePex™ device is designed to enable bloodless male circumcision procedure with no anesthesia and no sutures.
16127178|NCT01956370|Procedure|Surgical circumcision|The penis will be surgically circumcised according to one of the WHO recommended circumcision methods as described in the Manual for Male Circumcision under Local Anaesthesia Version 2.5C January 2008
16127179|NCT01956357|Other|Aquatic exercise|
16127180|NCT01956357|Other|Land Exercise|
16127181|NCT01956344|Behavioral|Cognitive Behavioral Therapy|Group cognitive-behavioral therapy for hoarding disorder, 16 weeks
16127182|NCT01956318|Behavioral|Crenobalneotherapy|18 days of balneotherapy session in 3 weeks. Each day, the treatment associates 4 techniques: Kneipp Therapy, walking pool, underwater massage, bath tub and finishing with 20 minutes of rest in the Trendelendburg position. Kneipp Therapy is an alternating warm (28°C) and cold (14°C) shower on the legs during 10 minutes. Walking pool is a 60 cm deep pool at 23°C with underwater shower where patients are walking without stopping during 10 minutes. Underwater massage is realized by a senior physiotherapist. It starts at the feet and gradually rises to the thighs during 10 minutes. Bath tub is underwater shower at 30°C. It also starts at the feet and gradually rises to the thighs during 20 minutes. The interventions are standardized by timers. Adherence to each technique is supervised before each session in the usual manner for each patient treated in the spa center.
16127183|NCT01956305|Drug|DS-7309|DS-7309 powder in bottle
16127184|NCT01956305|Drug|placebo|placebo to match DS-7309 powder in bottle
16127185|NCT01956305|Drug|Metformin|Metformin 500mg tablet for Cohort F
16127186|NCT01956279|Drug|Pregnenolone|Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x 28 days
16127187|NCT01956279|Drug|Placebo|Placebo 50mg BID x 14 days, followed by Placebo 150 x 14 days, followed by Placebo 250 mg BID x 28 days
16127188|NCT01956266|Behavioral|Emotional prosodic treatment|The experimental treatment is consistent with the standard treatment in that it targets impairments in pitch/stress, loudness variability and control of speech rate, the core characteristics of prosodic insufficiency in PD (Darley, Aronson & Brown, 1969). However, the experimental treatment provides an innovative and targeted emphasis on the emotional component of the disorder. The production of emotional intonation in an utterance requires varying combinations of pitch/stress, loudness, and rate. Participants will receive clinician feedback as well as auditory and visual feedback on accuracy via the VisiPitch display.
16127189|NCT01956253|Drug|Neratinib|240 mg orally once daily
16127190|NCT01956240|Procedure|Stretching-Asymptomatic subjects|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
16127191|NCT01956240|Procedure|Stretching-Subjects with shoulder pain|The stretching will be performed with the subject standing, with 90° of arm abduction and 90° of elbow flexion and palm on a flat planar surface. The subject then will place the leg opposite to the flat surface in front of the other with slight knee flexion and tilt the trunk forward like a rigid block and rotate it slightly increasing the horizontal abduction at the shoulder. This procedure will be done 4 times for 1 min and 30s interval between repetitions.
16127192|NCT01956227|Behavioral|Home-based exercise|exercise to look at balance and lower limb strength record in diary
16127193|NCT01956227|Behavioral|Education|sessions to discuss self-management ideas to modify risk of falling
16127194|NCT01956227|Behavioral|Exercise plus Education|combination of exercise sessions with education sessions to modify fall risk
16127195|NCT01956214|Other|FES Exercise|receive FES while exercising
16127196|NCT01956214|Other|Mock FES Exercise|participants will receive Mock FES
16127197|NCT01956201|Drug|Atorvastatin 20mg|[Atorvastatin Run-in Period] Take Atorvastatin 20mg 1 tablet once a day (after breakfast) [Treatment Period] Take Atrovastatin 20mg/Fenofibrate 160mg or Atorvastiatin 20mg/Placebo of Finofibrate 160mg 2 tablet once a day (after breakfast) [Extension Period] Take Atrovastatin 20mg, Fenofibrate 160mg 2 tablet once a day (after breakfast)
16127198|NCT01956201|Drug|Fenofibrate 160mg|Refer to Intervention Description of Atorvastatin 20mg
16127199|NCT01956201|Other|Placebo (Fenofibrate 160 mg)|Refer to Intervention Description of Atorvastatin 20mg
16127200|NCT01956188|Dietary Supplement|EPA and DHA supplementation|Subjects will be given 3g/d (1,2g of DHA and 1,8g of EPA) - 5 capsules per day.
16127201|NCT01956188|Dietary Supplement|Placebo|Subjects will be given 3g/d of soy oil - 5 capsules per day.
16127249|NCT01955759|Drug|rosuvastatin 20 mg tab x1|starting 7 days before coronary by-pass surgery
16127257|NCT01955720|Drug|Placebo|
16127202|NCT01956175|Device|Electrical pharyngeal stimulation|Electrical pharyngeal stimulation via an intraluminal catheter (Phagenesis Ltd.) once daily for 10 minutes on three consecutive days. The intensity of the electrical stimulation is determined following the calculation of suitable sensory threshold, tailored to the individual participants. After determining the optimal stimulation intensity, 10 minutes of stimulation are delivered.
16127203|NCT01956175|Device|Sham stimulation|The intraluminal catheter (Phagenesis Ltd.) for electrical pharyngeal stimulation is placed. The intensity of the electrical stimulation is determined following the calculation of suitable sensory threshold, tailored to the individual participants. After the optimal stimulation intensity has been determined, no electrical stimulation is delivered.
16127204|NCT01956162|Device|Orthèse Diabète|The device ensures the discharge of the wound by the excavation of the orthopedic insole facing the wound and the load distribution in the healthy areas.
16127205|NCT01956162|Device|"Conventional Device"|Standard (e.g.: CHUT, BAROUK, Tera-Diab, Sanital, Teraheel, Aircast boots, Walker Stabil D, etc.), or customized (orthopedic insole, Ransart boot, D.T.A.C.P., etc.) removable off-loading systems
16127206|NCT01956149|Drug|Cabazitaxel|20 mg/m2 over 1 hour i.v., repeated on day 22 for maximum 6 cycles.
16127207|NCT01956136|Behavioral|Music-based Neurological Rehabilitation (MBNR)|Music-based Neurological Rehabilitation (MBNR) will involve 10 weeks of individual training (30 sessions, 1 hour per session, 3 days per week) given by a trained music therapist. The MBNR protocol utilizes structured cognitive-motor training with drums (drum set, djembe drums) and creative musical expression (music playing, song writing) with piano that are geared towards engaging and training attention, executive functions, working memory, and upper-extremity functions and for enhancing emotional self-expression, adjustment, and mood after TBI.
16127208|NCT01956136|Other|Standard Care (SC)|Standard Care (SC) consists of other types of conventional rehabilitation (physical therapy, occupational therapy, speech therapy, and/or neuropsychological rehabilitation) and medical care for TBI that the patients receive in Finnish private or public health care.
16127209|NCT01956123|Drug|Follitropin Delta (FE 999049)|
16127210|NCT01956123|Drug|Follitropin Alfa (GONAL-F)|
16127211|NCT01956110|Drug|Follitropin Delta (FE 999049)|
16127212|NCT01956110|Drug|Follitropin Alfa (GONAL-F)|
16127213|NCT01956097|Dietary Supplement|HX106 590mg|
16127214|NCT01956097|Dietary Supplement|HX106 1180mg|
16127215|NCT01956097|Dietary Supplement|Placebo|
16127216|NCT01956084|Drug|LMP1/2 CTLs (Group A)|"Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules:
~Dose Level One:
~Day 0: 1 x 107 cells/m2 Day 14: 1 x 107 cells/m2
~Dose Level Two:
~Day 0: 2 x 107 cells/m2 Day 14: 2 x 107 cells/m2
~Dose Level Three:
~Day 0: 5 x 107 cells/m2 Day 14: 5 x 107 cells/m2"
16127217|NCT01956084|Drug|LMP1/2 CTLs (Group B)|"Each patient will receive 2 injections, 14 days apart, according to the following dosing schedules:
~Dose Level One:
~Day 0: 1 x 107 cells/m2 Day 14: 1 x 107 cells/m2
~Dose Level Two:
~Day 0: 2 x 107 cells/m2 Day 14: 2 x 107 cells/m2
~Dose Level Three:
~Day 0: 5 x 107 cells/m2 Day 14: 5 x 107 cells/m2"
16127218|NCT01956071|Device|WAPD|The objective was to assess workers' acceptability of the Pennington Pedal Desk.
16127219|NCT01956058|Radiation|brachytherapy remedial|brachytherapy remedial will be performed with injection of hyaluronic acid gel to interface prostate / rectum to push the rectum back and protect it from radiation.
16127220|NCT01956045|Other|Patient's capacity|
16127221|NCT01956019|Device|MRI scanning|
16127222|NCT01956006|Drug|Milrinone|Administration of study medications, PK sampling and safety profile- add on haemodynamic invasive measurements if patient consents to.
16127223|NCT01955980|Drug|Budesonide|Inhalation
16127224|NCT01955980|Drug|Budesonide|Nasal Spray
16127225|NCT01955967|Drug|Lidocaine|
16127226|NCT01955954|Device|Canary Breathing System|The Canary Breathing System is a biofeedback device meant to assist patients in the re-training of abnormal breathing patterns.
16127227|NCT01955928|Behavioral|Online Cognitive behavioral treatment for insomnia|
16127228|NCT01955889|Behavioral|Mobile Health Technology|
16127229|NCT01955889|Behavioral|Stretching & Strengthening Exercises|
16127230|NCT01955889|Behavioral|Walking with Pedometer|
16127231|NCT01955876|Drug|Lanthanum Carbonate (Fosrenol, BAY77-1931)|Patients treated with Fosrenol in daily clinical practice.
16127232|NCT01955863|Procedure|patient discharge on postoperative day 2|The patient was discharge on postoperative day 2 (as was done routinely)
16127233|NCT01955863|Procedure|patient discharge on postoperative day 1|The patient was discharge on postoperative day 1
16127234|NCT01955863|Procedure|patient discharge in the day of surgery|The patient was discharge in the evening of the same day of surgery (average 12 hours of hospitalization)
16127235|NCT01955850|Behavioral|Cognitive behavioral treatment for insomnia|Cognitive behavioral treatment for insomnia, consisting of: psycho-education, sleep hygiene, stimulus control, sleep restriction, cognitive therapy.
16127236|NCT01955837|Drug|TAS-102|TAS-102 (35 mg/m2/dose) orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.
16127237|NCT01955837|Drug|Placebo|Placebo orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.
16127238|NCT01955824|Drug|1% lignocaine|
16127239|NCT01955824|Drug|2% lignocaine|
16127240|NCT01955811|Drug|Administration of platelet concentrate and taking blood samples|Patient with the need of a platelet transfusion, will have 4 intervention points. 1. directly before the start of the transfusion a blood sample will be drawn. 2. Patient receives the platelet transfusion. 3. One hour after the end of transfusion a second blood sample will be drawn. 4. 24 h after the end of the platelet transfusion a further bloos sample will be collected. The first two samples will be (beside blood cell counts) spiked in-vitro with different amounts of Human fibrinogen and blood clotting tests will be performed. The same with the 3. blood sample, but without spiking steps.
16127241|NCT01955798|Procedure|Laparoscopic direct entry Trocar|Laparoscopic direct entry with trocar
16127242|NCT01955798|Procedure|Laparoscopic entry Veress needle|Laparoscopic entry with Veress needle
16127243|NCT01955798|Device|Trocar|
16127244|NCT01955798|Device|Veress needle|
16127245|NCT01955785|Device|pressure controlled ventilator|
16127260|NCT01955707|Drug|natalizumab|Administered as described in the treatment arm
16127261|NCT01955707|Drug|Placebo|Matched placebo
16127262|NCT01955694|Drug|BAY94-8862|2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg, and 20 mg of BAY94-8862 tablets
16127263|NCT01955694|Drug|Eplerenone|INSPRA 25 and 50 mg tablets (MAH: Pfizer) will be used for eplerenone 25 and 50 mg tablets
16127264|NCT01955694|Drug|Placebo|matching placebo
16127265|NCT01955668|Drug|Administration of AZD6738|An oral formulation of AZD6738 will be used. The starting dose of 20 mg BD will be escalated to reach a maximum tolerated dose in patients as defined by dose-limiting toxicity. A '3 week on, 1 week off' schedule, as deemed optimal in modelling of data from non-clinical studies, will be used initially
16127266|NCT01955655|Drug|Baclofen|Since the therapeutic window of Baclofen is narrow, the lowest dose compatible with an optimal response was used.
16127267|NCT01955655|Other|Placebo|
16127268|NCT01955642|Drug|Clopidogrel|75 mg milligrams per days of PLAVIX
16127269|NCT01955629|Drug|Aflibercept AVE0005|Pharmaceutical form: Concentrate for solution for infusion; Route of administration: Intravenous
16127270|NCT01955629|Drug|Oxaliplatin|Pharmaceutical form: Concentrate for solution for infusion; Route of administration: Intravenous
16127271|NCT01955629|Drug|Capecitabine|Pharmaceutical form: Tablets; Route of administration: Oral
16127272|NCT01955616|Drug|RM-131|
16127273|NCT01955616|Drug|Placebo|
16127274|NCT01955603|Drug|NNC0215-0384|A total of seven once-weekly doses of NNC0215-0384 or placebo will be administered subcutaneously (s.c., under the skin) at one of three ascending dose levels. Each cohort will consist of eight subjects randomised to either active (6 subjects) or placebo (2 subjects) treatment. Each subject will participate in one cohort only. Dose-escalation to the next dose level will be initiated when the safety data has been evaluated and if considered safe.
16127275|NCT01955603|Drug|placebo|Placebo administered corresponding to NNC0215-0384 treatment
16127276|NCT01955590|Behavioral|Metacognitive therapy|8-12 sessions of manualized metacognitive therapy
16127277|NCT01955590|Behavioral|EMDR|8-12 sessions of manualized EMDR
16127278|NCT01955590|Behavioral|Treatment as usual|8-12 sessions of treatment of usual
16127279|NCT01955577|Drug|Placebo orally everyday|
16127280|NCT01955577|Drug|Vitamin D3 cholecalciferol|
16127281|NCT01955564|Drug|NW-3509a|single dose
16127282|NCT01955551|Behavioral|Motivational Interviewing|In the Motivational Interviewing study arm, participants will receive MI phone calls designed to evoke change talk and to prompt the participant to identify goals in regards to child behavior or parenting. The caller will engage in problem solving with the participants.
16127283|NCT01955551|Behavioral|Anticipatory Guidance on Child Development|In the Anticipatory Guidance on Child Development study arm, the participants will receive two phone calls with no MI content. The content of these phone calls is derived from an alignment of the Teaching Strategies GOLD® standards with the Head Start Development and Early Learning Framework. , This content is entirely scripted and pre-specified.
16127284|NCT01955538|Other|Control|Psychiatric treatment as usual for 6 months according to best clinical practice.
16127285|NCT01955538|Other|Basic Body Awareness Therapy|20 weeks, 1 hour/week.
16127286|NCT01955538|Other|Mixed physical activity|20 weeks, 1 hour/week.
16127287|NCT01955512|Drug|Clopidogrel|Clopidogrel 75mg daily for 7 days
16127288|NCT01955512|Drug|Placebo|Matched placebo
16127289|NCT01955499|Drug|Ibrutinib|Given PO
16127290|NCT01955499|Drug|Lenalidomide|Given PO
16127291|NCT01955499|Other|Pharmacological Study|Correlative studies
16127292|NCT01955486|Other|flight simulation|
16127293|NCT01955473|Drug|Sym004|Part-A (dose-escalation): Sym004 will be administered intravenously either weekly at 6 to 12 milligram per kilogram (mg/kg) or biweekly at 18 mg/kg from Week 1 until unacceptable toxicity, disease progression, or consent withdrawal. Part-B (dose-expansion): After the maximum tolerated dose (MTD) is determined in Part-A, up to 30 additional subjects will continue to receive treatment in Part-B.
16127294|NCT01955460|Biological|Aldesleukin|Given IV
16127295|NCT01955460|Drug|Cyclophosphamide|Given IV
16127296|NCT01955460|Drug|Fludarabine Phosphate|Given IV
16127297|NCT01955460|Other|Laboratory Biomarker Analysis|Correlative studies
16127298|NCT01955460|Biological|NGFR-transduced Autologous T Lymphocytes|Given IV
16127299|NCT01955460|Biological|TGFbDNRII-transduced Autologous Tumor Infiltrating Lymphocytes|Given IV
16127300|NCT01955447|Dietary Supplement|no added plant-based ingredients to starchy meal|no added plant-based ingredients to starchy meal
16127301|NCT01955447|Dietary Supplement|Low level plant-based ingredients added to starchy meal|Low level plant-based ingredients added to starchy meal
16127302|NCT01955447|Dietary Supplement|Medium level plant-based ingredients added to starchy meal|Medium level plant-based ingredients added to starchy meal
16127303|NCT01955447|Dietary Supplement|High level plant-based ingredients added to starchy meal|High level plant-based ingredients added to starchy meal
16127304|NCT01955434|Drug|Cyclophosphamide|Given PO
16127305|NCT01955434|Other|Laboratory Biomarker Analysis|Correlative studies
16127306|NCT01955434|Other|Pharmacological Study|Correlative studies
16127307|NCT01955434|Other|Quality-of-Life Assessment|Ancillary studies
16127308|NCT01955434|Drug|Smac Mimetic LCL161|Given PO
16127309|NCT01955421|Drug|Erlotinib 100mg qd|
16127310|NCT01955421|Drug|Gefitinib 250mg qd|
16127311|NCT01955408|Other|Questionnaires, anticholinergic treatment, urodynamic study|
16127312|NCT01955395|Behavioral|Relaxation Response Resiliency Program (3RP)|The intervention will consist of one intake with a psychologist (approximately 60 minutes), 8 3RP sessions once a week over the course of 8 weeks (approximately 1 hour and 30 minutes each), and one exit visit (approximately 30 minutes) over the course of 3-months. During the intervention, the participant will be asked to practice what the participant has learned in the intervention by listening to a 20-minute audio CD daily. Additionally, the participant will be asked to keep track of their daily practice by filling out an online or paper log. During the 3RP session, the clinician will address any barriers or problems the participant may be having with the daily practice and help to problem solve them with the participant.
16127336|NCT01955200|Drug|Clopidogrel|(ASA 100mg daily + Clopidogrel 75mg daily) x 12 month.
16127313|NCT01955382|Drug|Actidose Aqua|Actidose Aqua (oAC) (Paddock Laboratories is sold over the counter in the United States in bottles containing 25 g/120 mL (NDC # 0574-0121-04) or 50 g/240 mL (NDC # 0574-0121-08). oAC is stable at room temperature.
16127314|NCT01955382|Drug|Artesunate|Artesunate (AS) obtained from Guilin Pharma (Shanghai), the only pharmaceutical company GMP pre-qualified by the WHO. The product artesunate for injection + 5% sodium carbonate inj + 0.9% sodium chloride inj will be delivered in vials of 30 mg and 60- mg vials, respectively, and will be dosed at 2.4 mg/kg as recommended for SM treatment by the WHO
16127315|NCT01955382|Drug|Amodiaquine|Amodiaquine obtained from Pfizer (Dakar), is provided as 200-mg tablets or syrup (50 10 mg/mL), and will be provided as age-based doses per the manufacturer's directions.
16127316|NCT01955356|Procedure|Scratching|Endometrial biopsy
16127317|NCT01955330|Procedure|Robotic Hybrid coronary artery revascularization|Lita to LAD performed by robot, Hybrid stent to other diseased coronary artery
16127318|NCT01955317|Behavioral|Hand cleansing with chlorhexidine|Pregnant women in the intervention arm will receive an intensive hand cleansing promotion delivered at 3 in-home visits between one month prenatal and 1 week post natal. The intervention will promote and discuss with mothers the benefits of hand cleansing with chlorhexidine before breastfeeding, before umbilical cord care, after contact with respiratory secretions, and the convenience of using a waterless hand sanitizer especially during the neonatal period. Each mother will receive a half-liter pump bottle with chlorhexidine lotion. The program will also educate mothers about infectious causes of morbidity and mortality in neonates and promote understanding of the risk to the neonate from these diseases.
16127319|NCT01955317|Behavioral|Mother and neonatal health counselling|This arms will receive maternal and neonatal health counselling which includes discussion and education about antenatal care, safe and clean delivery, recognition of danger signs for the mother and neonate, immediate new born care, and essential new born care. Each mother will receive a clean delivery kit and pictoral cue cards for danger sign recognition.
16127320|NCT01955304|Drug|fruquintinib|Fruquintinib 4 mg capsule, 2 discrete single doses separated by 2-weeks
16127321|NCT01955291|Device|Reinforced Feedback in Virtual Environment (RFVE)|"The patients allocated to RFVE group, will be treated using the Virtual Reality Rehabilitation System (VRRS). During the virtual therapy the subject will be seated in front of the wall screen grasping a sensorized real object with the affected hand. If the grasp is not possible the sensors will be fixed on a glove worn by the patient. The real object held by the subject, equipped with electromagnetic sensors, is matched to the virtual handling object. Thereafter, the patient moved the real object (e.g. ball) following the trajectory of the corresponding virtual object displayed on the computer screen in accordance with the requested virtual task."
16127322|NCT01955291|Other|Traditional Neuromotor Rehabilitation|The patients randomized to the Traditional Neuromotor Rehabilitation group will be asked to perform exercises for postural control, exercises for hand pre-configuration, exercises for the stimulation of manipulation and functional skills, exercises for proximal-distal coordination. All the exercises will be performed with or without the assistance of a physiotherapist. The upper limb motricity will be trained with progressive complexity. To achieve the requested goal (in a horizontal or vertical plane) patients will be asked to perform various movements, for example: shoulder flexion and extension, shoulder abduction and adduction, shoulder internal and external rotation and shoulder circumduction, elbow flexion and extension, forearm pronation and supination, hand grasping-release and clenching into a fist.
16127323|NCT01955278|Device|Definitive end colostomy with mesh|In the mesh group, a synthetic prosthetic mesh low weight type Ultrapro (15x15 cm) will be used. It will be placed in a sublay position between the rectus abdominis muscle and the posterior rectus sheath, will be sutured to the posterior rectus sheath with absorbable multifilament stitches. Once positioned and fixed the mesh the bowel will be brought out through a cross cut in the center of the mesh Finally, colon will be fixed by colocutaneous end to end absorbable multifilament sutures.
16127324|NCT01955278|Other|Conventional definitive end colostomy|
16127325|NCT01955265|Behavioral|Sports mentorship programme|1.5-hour sports mentorship session once a week, 18 weeks total.
16127326|NCT01955265|Behavioral|Health promotion|The access to a health promotion website any time during the intervention period. The website contains general health information including those related to physical activity.
16127327|NCT01955252|Drug|Azithromycin|"Investigators will do a baseline survey of every children from 5 to 15 years in the village. To detect yaws infection, investigators will collect a blood specimen for serology (qualitative and quantitative RPR testing and TPHA assay).
~Investigators will identify yaws-like ulcers by means of dermatological examination. Investigators will swab papilloma and ulcers and specimens will be flown to University of Washington (Seattle). PCR methods will consist of primary screening for the presence or absence of T. p. pertenue DNA, Haemophilus ducreyi DNA and detection of the A2058G and A2059G mutations associated with azithromycin resistance.
~Investigators will begin treatment with antibiotics immediately after completion of the baseline survey. Everyone in the villages will be offered azithromycin, subsequently a field team will treat all active clinical cases and their contacts 6 monthly.
~For all subjects, follow-up examination will be performed at 6,12,18,24,30,36,40,and 42 months"
16127328|NCT01955239|Radiation|Intensity-modulated Radiotherapy|
16127329|NCT01955226|Other|Tegaderm CHG clear dressing|Tegaderm CHG clear dressing will be used in central line care and will remain uniform as dictated by the central line maintenance bundle currently directing central line care in our children's hospital.
16127330|NCT01955226|Other|Standard clear Tegaderm dressing|Standard clear Tegaderm dressing will be used in central line care and will remain uniform as dictated by the central line maintenance bundle currently directing central line care in our children's hospital.
16127331|NCT01955213|Drug|methylnaltrexone|Patients will be treated with methylnaltrexone in a standard dosing regimen for their weight: 38-62kg:8 mg, 62-114kg:12 mg, >114 kg: 0.15 mg/kg) Methylnaltrexone will be administered subcutaneously every other day for up to 7 doses.
16127332|NCT01955200|Drug|Clopidogrel|(ASA 100mg daily + Clopidogrel 150mg daily) x 1 month; (ASA 100mg daily + Clopidogrel 75mg daily) x 11 month.
16127333|NCT01955200|Drug|Cilostazol|(ASA 100mg daily + Clopidogrel 75mg daily + Cilostazol 150mg Bid) x 1 month; (ASA 100mg daily + Clopidogrel 75mg daily) x 11 month.
16127334|NCT01955200|Drug|Ticagrelor|(ASA 100mg daily + Ticagrelor 90mg Bid) x 1 month; (ASA 100mg daily + Clopidogrel 75mg daily) x 11 month.
16127335|NCT01955200|Drug|Clopidogrel|(ASA 100mg daily + Clopidogrel 75mg daily) x 12 month.
16127337|NCT01955187|Drug|TACROLIMUS|Initial dose: 0.05 mg/Kg/day, adjusted to achieve blood trough levels of 5-7 ng/ml) for six months. Starting at the end of month 6, tacrolimus dosage will be reduced by 25% per month, resulting in a complete withdrawal at the end of month 9.
16127338|NCT01955187|Drug|RITUXIMAB|A dose 1 g IV will be given during month 6 (at day 180), before the onset of tacrolimus dose reduction
16127339|NCT01955187|Drug|METHYLPREDNISOLONE|Month 1: 1g IV methylprednisolone daily for three doses (days 1, 2, and 3), Oral methylprednisolone (0.5mg/kg/day) for 27 days (days 4 to 30). Months 3, and 5: Repeat Month 1.
16127340|NCT01955187|Drug|CYCLOPHOSPHAMIDE|Month 2: Oral Cyclophosphamide (2.0 mg/kg/day) for 30 days. Months 4, and 6: Repeat month 2.
16127341|NCT01955174|Drug|Esophageal endoscopic injection of botulinum toxin|Endoscopic injection of botulinum toxin in the esophageal muscle : one hundred units of type A botulinum toxin (Botox®, Allergan) diluted in 10 mL of normal saline and injected at the lower third of the esophageal wall in 10 sites between 2 and 10 cm above the Z-line.
16127342|NCT01955174|Other|No injection of botulinum toxin|Upper gastro-intestinal endoscopy without any injection
16127343|NCT01955161|Drug|Placebo|Once daily, matching placebo capsules, orally
16127344|NCT01955161|Drug|Idalopirdine|Once daily, encapsulated tablets, orally
16127345|NCT01955135|Drug|Ketamine|1mg/kg bolus intravenous, 0.25mg/kg/hour intravenous for maintenance of sedation
16127346|NCT01955135|Drug|Sevoflurane|anesthesia was induced using 8% sevoflurane by inhalation with 50% nitrous oxide in oxygen; Anesthesia was maintained with sevoflurane (2%) and 50% nitrous oxide in oxygen
16127347|NCT01955135|Drug|propofol|1 mg/kg propofol as a bolus for induction. The patients then received an infusion of 100-150 mcg/kg/min propofol
16127348|NCT01955122|Device|Tandem Colonoscopy|Each patient will undergo a double procedure: standard colonoscopy using the EndoRings™ add-on device and Standard colonoscopy (without using the EndoRings™ add-on device) in a randomized order.
16127349|NCT01955109|Biological|Viaskin Peanut 250 mcg|Subjects epicutaneously administered for 24 hours every 24 hours with a patch containing 250 mcg peanut proteins as whole peanut extract
16127350|NCT01955096|Procedure|fast-track surgery|The included patients will be randomly divided to two groups :30 that will undergo LAG with FTS rehabilitation programme and 31 that also will undergo LAG but receive conventional postoperative care.Laparoscopy-assisted gastrectomy will be carried out in this approach.There will be no difference in the surgical procedures of both groups.The criteria for discharge are: tolerance of solid diet, return of bowel habits and ability to walk on their own.
16127351|NCT01955096|Procedure|conventional postoperative care|The included patients will be randomly divided to two groups :30 that will undergo LAG with FTS rehabilitation programme and 31 that also will undergo LAG but receive conventional postoperative care.Laparoscopy-assisted gastrectomy will be carried out in this approach.There will be no difference in the surgical procedures of both groups.The criteria for discharge are: tolerance of solid diet, return of bowel habits and ability to walk on their own.
16127352|NCT01955083|Device|Pillar implant|Subjects receive pillar implant of the soft palate under local anesthesia as an outpatient procedure on sitting position. Using the delivery tool of the pillar implant system, the mucosa of the soft palate close to the hard palate-soft palate junction (approximate 0.5 cm) was punctured in the midline. The needle was inserted to the uvular muscle and moved parallel to the curve of the soft palate towards the tip of the uvula. After reaching the insertion point, the implant was delivered steadily after which the needle was withdrawn. This process was repeated for the second and third implants in the bilateral para-midline with a 0.2 cm horizontal distance from the first implant.
16127353|NCT01955083|Device|Radiofrequency|Subjects receive radiofrequency under local anesthesia as an outpatient procedure on sitting position. radiofrequency energy was delivered via a generator (Somnus® Model S2, Gyrus-ACMI Corporation, Maple Grove, MN, USA) with the power set to 10 watts and the maximal target temperature to 85°C. The needle electrode was inserted through the mucosa into the muscle layer at the entry points (approximately 1 cm below the hard palate-soft palate junction). The electrode was kept in place until 600 J had been delivered at the midline and 300 J at both para-midline sites (approximately 1 cm horizontal distance).
16127354|NCT01955070|Other|Multimedia Presentation for Ketamine sedation|PowerPoint presentation created with approval of section of emergency medicine for informed consent for ketamine sedation
16127355|NCT01955057|Behavioral|Research interviews|
16127356|NCT01955057|Behavioral|Tests (Fagerström, Q-MAT, H.A.D.S, SCL 90-R)|
16127357|NCT01955057|Behavioral|Projective methods (Thematic apperception Test, Rorschach)|
16127358|NCT01955057|Behavioral|Carbon monoxide test|
16127359|NCT01955044|Dietary Supplement|LCPUFA supplement|
16127360|NCT01955044|Dietary Supplement|placebo|
16127361|NCT01955031|Other|telemonitoring|A telemonitoring program with educational tools is given to people with type 2 diabetes at their home. It is composed of three softwares to improve eating habits available on touchpad, a self-monitoring blood glucose device, a balance to measure weight and fat mass, and a pedometer to evaluate physical activity. Data are securely sent and stored into a web service which delivers a synthesis to patients and health professionals.
16127362|NCT01955031|Other|Usual care|Patients are recruited during therapeutic educational sessions or appointments by general practitioners or diabetologists who take part into the Regional Health Network in Diabetes DIAMIP. If patients accept to participate to the study and sign up the protocol consent, they are given questionnaires about nutrition, physical activity and quality of life. A dietician analyses with each patient the results of a food inquiry. Patients are randomised into two groups: one arm is trained to the telemonitoring program before receiving it at home, and the other arm follows usual care. During 12 months, the telemonitoring group uses the device. The investigators (GP or diabetologists) can use the specific secured website to follow the measured parameters and to make appropriate decisions about health care of their patient. No consultation are scheduled in advance.
16127363|NCT01955018|Device|New algorithm called VeoTM (General Electric Healthcare, Milwaukee, MI, USA)|The objective of the present study is to compare Veo with the gold standard FBP for detecting pulmonary asbestos-related conditions among workers previously exposed to asbestos. Comparisons included radiation delivered and image quality.
16127364|NCT01955005|Behavioral|My HealtheVet Training|Participants will be asked to watch an on-line training video, review written materials, and print a document containing health information from their My HealtheVet account.
16127405|NCT01954732|Other|pharmacological study|Correlative studies
16127365|NCT01955005|Other|Internet Skills Training|Participants will review written training materials to learn how to search the Internet for health information and how to decide which Internet sites have good quality information.
16127366|NCT01954992|Drug|Glufosfamide|Glufosfamide: 4500 mg/m2 IV over 6 hours (¼ dose over 30 minutes, ¾ dose over remaining 5.5 hours) on Day 1 of each 21-day cycle.
16127367|NCT01954992|Drug|Fluorouracil|Fluorouracil (5-FU): 600 mg/m2 IV over 30 minutes on Day 1 of each week
16127368|NCT01954979|Drug|Abatacept|The study will follow a standard 3+3 design with two escalating doses of abatacept to determine the maximum tolerated dose (MTD): 3 mg/kg (dose level 1) and 10 mg/kg (dose level 2). Dose-limiting toxicities (DLTs) are defined as any Grade 3 or 4 toxicities judged to be probably or definitely related to abatacept.
16127369|NCT01954966|Drug|Progesterone|Participants will consume four pills of Progesterone over a period of four days. Participants will be asked to remain abstinent from smoking while taking Progesterone.
16127370|NCT01954966|Drug|Placebo|Participants will consume four pills of Placebo over a period of four days. Participants will be asked to remain abstinent from smoking while taking Placebo.
16127371|NCT01954940|Device|Whole Body Vibration Therapy|
16127372|NCT01954927|Drug|Gabapentin|Gabapentin is supplied as an oral suspension. Patients randomized to the gabapentin arm will receive a single dose of gabapentin as soon after enrollment as feasible. The gabapentin dose will be given orally and will be approximately 15 mg/kg with a maximum dose of 900 mg.
16127373|NCT01954927|Drug|Placebo|Placebo will be prepared by the SJCRH pharmacy and will be similar in appearance, quantity and taste to the gabapentin drug. Patients randomized to the placebo arm will receive a single dose of placebo as soon after enrollment as feasible. The placebo dose will be given orally and will be approximately 15 mg/kg with a maximum dose of 900mg.
16127374|NCT01954914|Drug|Plerixafor|Administration of a single dose of Plerixafor 240 µg/kg body weight of the donor SC in the evening at 10 PM after frustraneous stem cell apheresis on day 1.
16127375|NCT01954901|Device|Hyperbaric oxygen therapy|
16127376|NCT01954901|Device|Hyperbaric room air|
16127377|NCT01954888|Procedure|Blind technique|A mixture of 3 mL of 2% lidocaine and 7 mL of 0.5% bupivacaine is used for both approaches (blind and ultrasound-guided).
16127378|NCT01954888|Procedure|Ultrasound-guided technique|A mixture of 3 mL of 2% lidocaine and 7 mL of 0.5% bupivacaine is used for both approach (blind and ultrasound-guided).
16127379|NCT01954862|Other|Air Insufflation method.|Air Insufflation method.
16127380|NCT01954862|Other|CO2 insufflation|CO2 insufflation.
16127381|NCT01954862|Other|Water Immersion/CO2|Water Immersion during insertion, CO2 insufflation during withdrawal.
16127382|NCT01954862|Other|Water Exchange/CO2|Water Exchange during insertion, CO2 insufflation during withdrawal.
16127383|NCT01954862|Other|Water Immersion/AI|Water Immersion during insertion, AI insufflation during withdrawal.
16127384|NCT01954862|Other|Water Exchange/AI|Water Exchange during insertion, AI insufflation during withdrawal.
16127385|NCT01954849|Dietary Supplement|Probiotic formulation|
16127386|NCT01954836|Behavioral|initial fasting|modified fasting with daily caloric intake of <400kcal by juices starting 36 to 48 h before begin of chemotherapy and lasting to 24 h after end of chemotherapy applied in the first half of scheduled 4 or 6 chemotherapy cycles
16127387|NCT01954836|Behavioral|Secondary fasting|modified fasting with daily caloric intake of <400kcal by juices starting 36 to 48 h before begin of chemotherapy and lasting to 24 h after end of chemotherapy applied in the second half of scheduled 4 or 6 chemotherapy cycles
16127388|NCT01954823|Device|e-diary|"The e-diary can collect data on:
~Medical data: information on diseases, treatments and attending physicians
~Diary: daily report of drugs intake, symptoms and their intensity and additional relevant data
~Reminders: the application can send reminders on drug intake or medical appointments to cellular phones or emails
~Reports: textual and graphical reports of the data in the diary can be created"
16127389|NCT01954810|Biological|Japanese encephalitis chimeric vaccine (JECV)|Japanese encephalitis chimeric vaccine (JECV)will be administered to every children in the study for one dose and check for antibody response 4 weeks after vaccination
16127390|NCT01954784|Drug|fludarabine phosphate|
16127391|NCT01954784|Radiation|total-body irradiation|Undergo TBI
16127392|NCT01954784|Procedure|nonmyeloablative allogeneic hematopoietic stem cell transplantation|Undergo nonmyeloablative allogeneic hematopoietic SCT
16127393|NCT01954784|Drug|cyclosporine|Given PO
16127394|NCT01954784|Drug|mycophenolate mofetil|Given PO
16127395|NCT01954784|Drug|bortezomib|Given SC
16127396|NCT01954784|Drug|lenalidomide|Given PO
16127397|NCT01954784|Other|laboratory biomarker analysis|Correlative studies
16127398|NCT01954771|Behavioral|SMBG|"Control Group Patients will receive conventional care and keep on their usual SMBG methods. Additionally, each patient will also wear a CGMS device for 72h in the first week and the last week, respectively.
~SMBG-4 Group Capillary glucose level is measured using finger stick method by 4 times (fasting plus post-meals) every other day. Additionally, each patient will also wear a CGMS device for 72h in the first week and the last week, respectively.
~SMBG-7 Group Capillary glucose level is measured using finger stick method by 7 times (fasting, pre-meals, post-meals and bedtime altogether) every other day. Additionally, each patient will also wear a CGMS device for 72h in the first week and the last week, respectively."
16127399|NCT01954771|Other|CGMS|In this study, according to the protocol, all the patients will follow their prespecified SMBG methods and periodically visit doctor, but therapies will not be adjusted unless they experience severe hypoglycemia or hyperglycemia episodes. The expected duration of the trial is 12 weeks.
16127400|NCT01954758|Other|personalized Embryo Transfer (pET)|
16127401|NCT01954758|Other|Frozen Embryo Transfer (FET)|
16127402|NCT01954758|Other|Fresh Embryo Transfer (ET)|
16127403|NCT01954745|Drug|Cabozantinib|Cabozantinib 60 mg (free base weight) per day will be administered daily and continuously for a cycle length of 28 days. Subjects will be provided with a sufficient supply of study treatment and instructions for taking the study treatment on days without scheduled clinic visits. After fasting (with exception of water) for 2 hours, subjects will take study treatment daily with a full glass of water (minimum of 8 oz/ 240 mL) and continue to fast for 1 hour after each dose of study treatment.
16127404|NCT01954732|Drug|metformin hydrochloride|Given PO
16127406|NCT01954719|Procedure|cervix dilated after surgery|The surgeon inserted his or her double-gloved index digit in the cervical canal to dilate it and removed the outer gloves after digital dilatation of the cervix.
16127407|NCT01954719|Procedure|control group|surgeon not dilated cervix after surgery
16127408|NCT01954706|Other|Structured Exercise|Structured and supervised aerobic and resistance training 2 times per week
16127409|NCT01954706|Other|Usual Care|Subjects will be counseled on American Cancer Society and American College of Sports Medicine physical activity and nutritional guidelines at the initiation of the study. Study participants will be contacted by a physician or nurse on weeks 2, 6, 10, and 14 to provide support and encouragement to patients.
16127410|NCT01954693|Drug|Placebo|5mg daily administered for 6 months as two oral 2.5 mg tablets once daily.
16127411|NCT01954693|Drug|Everolimus (RAD001)|5mg daily administered for 6 months as two oral 2.5 mg tablets once daily
16127412|NCT01954680|Behavioral|COGFLEX-skill building levels|"COGFLEX--in English-- is a computer game designed to build up a specific skill that our work has shown is impaired in children and adolescents with bipolar disorder).
~In the R33, children will be randomized to receive either COGFLEX with skill-building levels or COGFLEX-control condition which is just baseline/non-probabilistic trials.
~All children will play COGFLEX twice per week for 8-weeks.
~This same approach has shown great success in many psychiatric disorders including schizophrenia.
~This is the first such study in children/adolescents with bipolar disorder."
16127413|NCT01954680|Behavioral|COGFLEX-control condition|"In the R33, the control condition will be the same COGFLEX game--but just baseline/non-probabilistic trials. All children will play COGFLEX twice per week for 8-weeks."
16127414|NCT01954654|Device|Custom-made compression sleeve and -gauntlet|Device: Compression garments worn for a minimum of six hours per day
16127415|NCT01954654|Other|Educational information, recommendation and instruction|Educational information and recommendations about lymphedema and skin care. Instruction in physical exercises to enhance the lymph flow
16127416|NCT01954641|Other|ACCURE Navigator|"The ACCURE Real-Time Registry will automatically alert the ACCURE Navigator to follow a schedule of patient-interactions. The Navigator has been trained to employ the teachback method of patient education as appropriate per encounter. For instance: (1) initial face-to-face interaction, after the patient's first visit with the oncologist; (2) telephone call 3 business days after the initial visit; (3) contact the patient 10-21 days after the initial visit; and (4) after treatment has begun, contacting the patient every 8 weeks.It is projected that 50% of the staff will attend the Healthcare Equity Training (HET) and Booster Sessions."
16127417|NCT01954641|Other|Usual Care by Cancer Center Care Team|The Usual Care group will receive the support and care that is usually given to patients at their designated cancer center.
16127418|NCT01954628|Drug|AQX-1125|Synthetic SHIP1 activator
16127419|NCT01954628|Drug|Placebo|Placebo control
16127420|NCT01954615|Drug|5 mg ACT-281959 prodrug formulation I (Group A)|
16127421|NCT01954615|Drug|20 mg ACT-281959 prodrug formulation I (Group B)|
16127422|NCT01954615|Drug|ACT-281959 prodrug formulation I (Groups C to G doses to be defined)|
16127423|NCT01954615|Drug|ACT-281959 prodrug formulation II (Group G dose to be defined)|
16127424|NCT01954615|Drug|ACT-246475 (Group G dose to be defined)|
16127425|NCT01954615|Drug|Placebo (Groups A to F)|
16127426|NCT01954602|Procedure|Guide-wire cannulation|Direct guide-wire hovering a few millimeters through the catheter or sphincterotome
16127427|NCT01954602|Procedure|Sphincterotome assisted guide-wire cannulation|Sphincterotome is inserted initially a few millimeters through the papillary orifice
16127428|NCT01954589|Drug|ACT-462206 5 mg|
16127429|NCT01954589|Drug|ACT-462206 25 mg|
16127430|NCT01954589|Drug|ACT-462206 100mg|
16127431|NCT01954589|Drug|ACT-462206 200mg|
16127432|NCT01954589|Drug|ACT-462206 400mg|
16127433|NCT01954589|Drug|ACT-462206 1000 mg|
16127434|NCT01954589|Drug|ACT-462206 1500mg|
16127435|NCT01954589|Drug|Almorexant 400mg|
16127436|NCT01954589|Drug|Placebo|
16127437|NCT01954576|Device|NovoTTF-100A|
16127438|NCT01954576|Procedure|Quality-of-life assessment|
16127439|NCT01954576|Genetic|Laboratory biomarker analysis|
16127440|NCT01954563|Biological|MVA85A|Modified vaccinia virus Ankara (MVA) is a highly attenuated strain of vaccinia with an antigen 85A insert.
16127441|NCT01954550|Behavioral|Cycling exercise|An exercise interventionist will guide and supervise participants to participate in moderate-intensity cycling on recumbent stationary cycles for 20-50 minutes, 3 times a week for 6 months.
16127442|NCT01954550|Behavioral|Range of motion/stretching exercise|An exercise interventionist will guide and supervise participants to participate in low-intensity range of motion/stretching exercise for 20-50 minutes, 3 times a week for 6 months.
16127443|NCT01954524|Drug|IV bolus injection of Sildenafil|"Dose escalation will be performed (in different participants). The doses will be as follows:
~CTP class B cirrhosis: A single 5 and 10 mg IV bolus injections of Sildenafil. CTP class C cirrhosis: A single 2.5, 5, 8 and 10 mg IV bolus injections of Sildenafil."
16127444|NCT01954511|Other|Manual therapy|The patient was supine with the cervical spine in a neutral position. The therapist brought about a contact of the occipital bone with the ﬁrst ﬁnger and medial aspect of the hand, and other hand over the frontal region of the patient's head. The mobilizing force was delivered by ﬂexing the upper cervical region using a combination of cephalic traction with the occipital hand and caudal pressure with the frontal hand. This technique was applied for 10 minutes
16127445|NCT01954511|Other|Manual therapy|The patient was prone with the cervical spine in a neutral position. The therapist placed the tips of his thumbs on the posterior surface of the C5 spinous process, while the other ﬁngers rested gently around the patients' neck. This technique was applied for 9 minutes
16127446|NCT01954511|Device|Pressure biofeedback device|Device: Stabilizer - Chattanooga Group Inc., Chattanooga, Tennessee, USA The cranio-cervical flexor stabilization exercise was done 10 times holding 10 seconds the flexing position graded through feedback from a pressure biofeedback device
16127447|NCT01954498|Dietary Supplement|Walnuts|
16127448|NCT01954498|Dietary Supplement|OTC multivitamin|
16127449|NCT01954485|Procedure|Dental implant placement with a final prosthetic abutment|
16127523|NCT01953952|Other|laboratory biomarker analysis|Correlative studies
16127450|NCT01954472|Behavioral|Enhanced portfolio plus structured exercise|"Foods on the dietary portfolio plan will contribute 9g/1000 kcal viscous fibre as β-glucan (oats, barley, oat bran breads and soups) and psyllium (cereal), 1g plant sterol/1000 kcal diet (in sterol margarine), 22.5g soy protein/1000 kcal (soy burgers, dogs, links, other soy meat analogues, soy milks, yogurts and cheese), and additional sources of plant protein from pulses (eg. Lentils, chickpeas, beans, etc) and 22.5g almonds or equivalent of other nuts/1000 kcal and increased MUFA (as olive and canola oils, avocados, nuts, margarine and salad dressings). The glycemic index will be reduced from 83 to 70 GI units (bread scale).
~Exercise: The physical activity/exercise program is based on the program used at the Quebec Heart and Lung Institute."
16127451|NCT01954472|Behavioral|High fiber diet plus routine exercise|"Dietary advice will be given to encourage intake of whole grain foods (brown rice, whole wheat breads, muffins and breakfast cereals); to reduce meat consumption, choose low fat dairy products and a control margarine.
~Exercise: A pamphlet (Canada's Physical Activity Guide, Health Canada) encouraging increased physical activity will be provided."
16127452|NCT01954459|Device|Insupatch|Device which applies local heating at 40 degrees Celsius to the vicinity of the subcutaneous site of glucose sensor.
16127453|NCT01954459|Device|Continuous glucose sensor|Glucose sensor inserted without warming patch
16127454|NCT01954446|Device|3M|Conventional measuring of BP
16127455|NCT01954446|Device|ContiPressTM|"New way of measuring BP - ContiPressTM
~Investigational device"
16127456|NCT01954446|Device|Mobil-O-Graph|2 different devices for oscillometric measurement of BP
16127457|NCT01954433|Procedure|Operated TSA Patients|Total shoulder prosthesis: Anatomic or reverse total shoulder replacement is a well-standardized procedure usually performed under general anesthesia with the patient in a beach-chair position
16127458|NCT01954433|Procedure|Operated RCR Patients|Arthroscopic rotator cuff tear reconstruction. The shoulder arthroscopy is performed according to internal and international standard procedure with patients positioned in beach-chair position under general anesthesia.
16127459|NCT01954433|Procedure|Resection interposition suspension arthroplasty (RISA)|"One of five surgical techniques can be used in this study, as routinely performed by each surgeon:
~RISA with FCR-Ligament (flexor carpi radialis ligament) modified according to Epping
~RISA with FCR-Ligament modified according to Weilby
~RISA with APL-Ligament (abductor pollicis longus ligament)
~RISA with Graftjacket modified according to Weilby
~Resection arthroplasty"
16127460|NCT01954420|Behavioral|Cognitive-Behavioral Intervention|Standard care + Selection of 12 recorded imagery- and non imagery-based cognitive-behavioral coping strategies provided on an MP3 player.
16127461|NCT01954420|Other|Attention Control|Standard care + Cancer education
16127462|NCT01954407|Behavioral|Smoking-Related Messages|
16127463|NCT01954394|Drug|Alirocumab|Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe.
16127464|NCT01954394|Drug|Lipid-Modifying Therapy (LMT)|Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.
16127465|NCT01954381|Device|transthoracic echocardiographic|
16127466|NCT01954381|Device|Doppler ultrasound.|
16127467|NCT01954381|Biological|blood samples|
16127468|NCT01954368|Drug|Placebo|"As soon as possible from ED admission, using a study drug volume schedule, triage nurse will administer to the patient a planned weight-based volume of intranasal placebo (normal saline solution).
~Half of the dose will be administrated in each nostril. The patient will then rapidly be brought to emergency room and after his pain being reassessed, appropriate treatment (following current recommendations) will be given by the ED nurse."
16127469|NCT01954368|Drug|Sufentanil|"As soon as possible from ED admission, using a study drug volume schedule, triage nurse will administer to the patient a weight-based volume (corresponding to 0,4 mcg/kg) of intranasal sufentanil.
~Half of the dose will be administrated in each nostril. The patient will then rapidly be brought to emergency room and after his pain being reassessed, appropriate treatment (following current recommendations) will be given by the ED nurse."
16127470|NCT01954355|Drug|LDE225|400, 600 and 800 mg OD
16127471|NCT01954355|Drug|Paclitaxel|80 mg/m2 (days 1, 8, 15)
16127472|NCT01954316|Drug|CFI-400945|Polo-like kinase 4 (PLK4) inhibitor
16127473|NCT01954303|Other|Progress of CHD|
16127474|NCT01954290|Drug|Conivaptan|Intravenous conivaptan 20 mg infused over 30 minutes as a loading dose, followed by a continuous infusion of 20 mg over 24 hours (0.83 mg/hour) for 2-4 days; may increase to a maximum dose of 40 mg over 24 hours (1.7 mg/hour) if serum sodium is not rising sufficiently; total duration of therapy not to exceed 4 days.
16127475|NCT01954290|Drug|Hypertonic saline|Hypertonic saline in the dose of 30ml/hr, with every 4 hourly measurements of serum osmolarity, serum sodium and potassium. Hypertonic saline will be increased by 30 ml to achieve target serum sodium of 150-160 and serum osmolarity 300-320
16127476|NCT01954290|Drug|Mannitol|Mannitol given at the dose of 0.5 to 1.0 gm/kg IV over 10-20 minutes. Maximum effect is seen in 20 minutes and duration of action is 4 hours. Repeat doses of 0.25 to 0.5 gm/kg Q 4-6 hours are normally frequently used.
16127477|NCT01954277|Device|Electroacupuncture|Eletroacupuncture performed using acupuncture needles.
16127478|NCT01954277|Device|Placebo Sham|Placebo Sham is performed using electrodes, without electrical stimulation. Lights and sounds were identical to active treatment.
16127479|NCT01954264|Procedure|Capillary blood sample|Capillary blood sample (up to 200µL) for determination of PP (blood slides).
16127480|NCT01954264|Other|Data collection|Prospective data collection at the study visit by the internet based Electronic Case Report Form (eCRF)
16127481|NCT01954251|Biological|Herpes Zoster vaccine GSK 1437173A|2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
16127482|NCT01954251|Biological|GSK Biologicals' quadrivalent seasonal influenza vaccine FLU-D-QIV GSK2321138A|2 doses administered intramuscularly (IM) in the deltoid region of the dominant arm.
16127517|NCT01953978|Drug|Paracetamol|Tablet Paracetamol 1 g orally, 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours.
16127518|NCT01953978|Drug|Ibuprofen|Tablet Ibuprofen 400 mg orally, 1 hour preoperatively and every 6 hours after extubation time during the first 48 hours.
16127519|NCT01953952|Procedure|therapeutic conventional surgery|Undergo transoral eHNS
16127520|NCT01953952|Radiation|intensity-modulated radiation therapy|Undergo IMRT
16127521|NCT01953952|Drug|cisplatin|Given IV
16127483|NCT01954238|Drug|GCC-4401C|"Orally active direct factor Xa inhibitor for use in the prevention and treatment of venous thromboembolic disease.
~The dose selection for this clinical study was based on the safety, Pharmacokinetics and Pharmacodynamics results of the single dose study.
~GCC-4401C was well tolerated in the single ascending dose study up to the highest single oral dose administered of 80 mg from 2.5 mg in 48 subjects.
~The study consists of five cohorts (10 mg, 20 mg, 40 mg, 60 mg, and 80 mg) with eight subjects per cohort.
~In the 20 mg cohort, six additional subjects will receive rivaroxaban (Xarelto®) 20 mg as an active comparator in open-label fashion."
16127484|NCT01954238|Drug|Rivaroxaban|Rivaroxaban (Xarelto®) 20 mg tablets for oral administration IMP, placebo and comparator will be administered the same time points. The comparator will be administered open-label 30 minutes after a standard breakfast.
16127485|NCT01954238|Drug|Placebo|GCC-4401C matching placebo(Capsule): Strength is not applicable. GCC-4401C and placebo will be administered double-blind after a 10 hours fast.
16127486|NCT01954225|Other|Udumbara Sutra|The Udumbara sutra is a standard medicated thread smeared with latex of Udumbara (Ficus Glomerata) which has cutting and healing property.
16127487|NCT01954212|Other|Enhanced complex oral health care|"Our proposed complex oral health care (OHC) intervention (SOCLE intervention) comprises 3 levels of intervention:
~Patient Level: An individualised OHC assessment on admission and individualised OHC plans for patients, which may involve staff-led OHC support, access to OHC equipment, products and specialist support services and OHC health promotion components.
~Staff Level: Specialist web-based OHC educational training, including information on the oral cavity and structures; oral health problems (e.g. decay, gum disease, dry mouth); instruction on OHC techniques, equipment and products; use of the SOCLE assessment and protocol tools.
~Service Level: Processes to facilitate access to specialist dental support services (e.g. dentist, hygienist, denture repair laboratory). Essential OHC equipment (toothbrushes, denture marking kits) and products (e.g. toothpaste, oral balance gel) on the ward will be available."
16127488|NCT01954199|Procedure|Neurodynamic Group|"All techniques will be executed in a pain-free way (grade III). Mild discomfort will be accepted, but it must subside as soon as the technique ends.
~In the dynamic opener technique, patient will be positioned in side-lying, with the affected side upwards. The therapist will then perform grade III oscillations aiming to open the lumbar foramen;
~In the side-lying slider, the patient will be in side-lying with the affected side upwards. A combination of knee and hip flexion and extension movements will produce sliding in the neural structures;
~In the slump slider, the patient will be seated in slump position. Combinations between neck and knee movements will produce greater nerve excursion than the side-lying slider. Patients will perform the slump slider in a pain-free manner."
16127489|NCT01954186|Drug|intravenous & intramuscular oxytocin|intravenous or intramuscular 10 iu oxytocin
16127490|NCT01954186|Procedure|after delivery of the fetus & when anterior shoulder seen|oxytocin 10 iu after the delivery of the fetus or when the anterior shoulder was seen after the fetal head was delivered
16127491|NCT01954173|Radiation|3D conformal radiation therapy|Undergo conformal radiation therapy
16127492|NCT01954160|Device|Symplicity Renal Denervation|Renal denervation
16127493|NCT01954147|Drug|GLP-1|GLP-1 therapy
16127494|NCT01954147|Biological|SC|Stem cell infusion
16127495|NCT01954147|Other|Standard Medical Treatment|Standard Medical Treatment
16127496|NCT01954121|Drug|Levetiracetam|"Immediate release film-coated tablets at strengths of 250 mg and 500 mg.
~Up-titration Period (Week 1 to Week 3): Levetiracetam (LEV) 250 mg twice daily (bid)
~Stabilization Period and Evaluation Period (Week 3 to Week 30): LEV 500 mg bid
~Down-titration Period (Week 30 up to Week 33)"
16127497|NCT01954121|Drug|Carbamazepine|"Immediate release tablets at a strength of 200 mg.
~Up-titration Period (Week 1 to Week 3): Carbamazepine- Immediate Release (CBZ-IR) 200 mg once daily (qd)
~Stabilization Period and Evaluation Period (Week 3 to Week 30): CBZ-IR 200 mg bid
~Down-titration Period (Week 30 up to Week 33)"
16127498|NCT01954108|Device|hyaluronic acid sodium salt|
16127499|NCT01954108|Device|ESWT|
16127500|NCT01954082|Drug|myo-Inositol 5% Injection|"Abbott Nutrition Division, Abbott Laboratories is supplying myo-Inositol 5% Injection to the clinical centers for the duration of the trial.
~Inositol: myo-Inositol 5% Injection is an isotonic, preservative-free, sterile 5% solution of myo-inositol in water containing 0.5 gm sodium chloride per liter (8.55mM), pH 6.5-7.5. It is administered via IV infusion using syringe pump over 15-30 minutes twice per day at 12-hour intervals at a dose of 80 mg inositol/kg/day (40 mg inositol/kg/dose), which is equivalent to 1.6 mL/kg/day (0.80 mL/kg/dose)."
16127501|NCT01954082|Drug|Placebo|% glucose(dextrose)
16127502|NCT01954069|Device|Semi-quantitative pregnancy test|
16127503|NCT01954056|Drug|Hydrocortisone|"• 7 day course of hydrocortisone (hydrocortisone sodium succinate, plain; will not have benzyl alcohol) given through intravenous line or by intramuscular injection if no intravenous line).
~1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose"
16127504|NCT01954056|Drug|Placebo|"7 days of intravenous or intramuscular placebo (normal saline in equal volume)
~1 mg/kg loading dose x 1; 0.5 mg/kg q 6 hours x 12 doses; 0.5 mg/kg q 12 hours x 4 doses; 0.5 mg/kg q day x 1 dose"
16127505|NCT01954043|Drug|Dabrafenib 150 mg twice a day (BID)|Dabrafenib dosed at 150mg twice a day from Day 1 to the morning of Day 29
16127506|NCT01954043|Drug|Rabeprazole 40 mg once daily (OD)|Rabeprazole dosed at 40mg each morning on Days 16 to 19
16127507|NCT01954043|Drug|Rifampin 600 mg OD|Rifampin dosed at 600mg each morning on Days 20 to 29
16127508|NCT01954030|Drug|CTO and Bevacizumab|
16127509|NCT01954030|Drug|CTO alone|
16127510|NCT01954017|Biological|STP206|Live Biotherapeutic
16127511|NCT01954017|Other|Control|Sterile Water
16127512|NCT01953991|Device|Dentures|Removable prosthesis to replace missing teeth
16127513|NCT01953978|Drug|Dexamethasone|Intravenous administration of dexamethasone 16 mg (concentration 4 mg/ml, volume 4 ml) immediately after endotracheal intubation
16127514|NCT01953978|Other|Placebo|Intravenous administration of isotonic sodium chloride (concentration 9 mg/ml, volume 4 ml) immediately after endotracheal intubation
16127515|NCT01953978|Drug|Morphine|Morphine. Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml.
16127516|NCT01953978|Drug|Zofran|Zofran 4 mg iv in case of moderate to severe nausea, supplemented by Zofran 1 mg iv if needed
16127522|NCT01953952|Procedure|quality-of-life assessment|Ancillary studies
16127524|NCT01953939|Other|Prosthetic Limb Users|There will be a time period of 7-10 days between data collection visits in this test-retest study which is measuring reliability in the functional outcome measures regularly used in clinical practice.
16127525|NCT01953926|Drug|Neratinib|240 mg administered orally, once daily with food, continuously in 28 day cycles
16127526|NCT01953926|Drug|Fulvestrant|500 mg administered as two 5 mL injections on Days 1, 15, and 29; then once every 4 weeks thereafter month, then Day 1 of every 4 week cycle
16127527|NCT01953926|Drug|Trastuzumab|Initial dose of 8 mg/kg of trastuzumab administered IV on Day 1, followed by 6 mg/kg IV once every 3 weeks thereafter
16127528|NCT01953913|Drug|Afatinib|Patient will receive afatinib once daily
16127529|NCT01953900|Genetic|GD2 T cells|"On dose levels 1 and 2 each patient receives one injection of GD2 T cells followed by VZV vaccine injection 42 days later.
~Dose Level 1: 1x10^6 cells/m^2
~Dose Level 2: 1x10^7 cells/m^2
~The next dose levels to be studied following Dose level 2 are Dose levels 7 and 8 where subjects will receive the VZV vaccine followed by a single infusion of iC9-GD2-CAR-VZV-CTLs within 48 hours after VZV vaccine:
~Dose Level 7: 1 x 10^7 cells/m2
~Dose Level 8: 1 x 10^8 cells/m^2
~Dose levels 9-11 will receive lymphodepleting chemotherapy with cyclophosphamide and fludarabine prior to administration of the T cells.
~Dose Level 9: 1 x 10^8 cells/m^2
~Dose Level 10: 5 x 10^8 cells/m^2
~Dose Level 11: 1 x 10^9 cells/m^2
~The previously planned dose levels 3-6 will not be studied."
16127530|NCT01953900|Biological|VZV vaccine|Subjects will receive a VZV vaccine with CTL infusion within 48 hours after the vaccine.
16127531|NCT01953900|Drug|Fludarabine|Pre-infusion lymphodepletion for dose levels 9-11: Patients will receive 3 daily doses of cyclophosphamide together with fludarabine to induce lymphopenia, finishing at least 24 hours before T cell infusion. Cyclophosphamide will be given at a dose of 500 mg/m^2/day followed by Fludarabine 30 mg/m^2/day. Infusions should be given following hospital/pharmacy recommendations however at a minimum the cyclophosphamide should be infused over 1 hour and the fludarabine should be infused over 30 minutes. Mesna, IV hydration, and anti-emetics will be provided following local institutional guidelines. T cell infusion will take place the day after completion of chemotherapy. Zostavax will be administered two weeks after infusion of T cells.
16127532|NCT01953900|Drug|Cyclophosphamide|Pre-infusion lymphodepletion for dose levels 9-11: Patients will receive 3 daily doses of cyclophosphamide together with fludarabine to induce lymphopenia, finishing at least 24 hours before T cell infusion. Cyclophosphamide will be given at a dose of 500 mg/m^2/day followed by Fludarabine 30 mg/m^2/day. Infusions should be given following hospital/pharmacy recommendations however at a minimum the cyclophosphamide should be infused over 1 hour and the fludarabine should be infused over 30 minutes. Mesna, IV hydration, and anti-emetics will be provided following local institutional guidelines. T cell infusion will take place the day after completion of chemotherapy. Zostavax will be administered two weeks after infusion of T cells.
16127533|NCT01953887|Drug|EC905|Oral
16127534|NCT01953887|Drug|solifenacin|oral
16127535|NCT01953887|Drug|tamsulosin|oral
16127536|NCT01953874|Device|MV ASV|Minute ventilation-targeted servo-ventilation therapy.
16127537|NCT01953874|Drug|Optimized Medical Treatment|Beta Blockers, ACE inhibitor or ARB, loop diuretics and/or spironolactone as appropriate, statin if indicated, aspirin and/or warfarin if indicated
16127538|NCT01953861|Drug|EC905|Oral
16127539|NCT01953848|Drug|EC905|Oral
16127540|NCT01953835|Drug|GSK2586184 standard formulation|GSK2586184 standard formulation is a white film coated round biconvex 200 mg oral tablet. For cohort A, it is to be administered at 400 mg (200 mg x 2 tablets) twice daily from Day 6 to Day 14. For cohort B, it is to be administered at 400 mg (200 mg x 2 tablets) single dose after standard breakfast either on Day 1, 4 and 7 according to the treatment sequence, each separated by a 3-day wash out period.
16127541|NCT01953835|Drug|Simvastatin|Simvastatin 10 mg oral tablet is peach-coloured, oval-shaped tablets. It is to be administered orally as a single dose of 10 mg tablet on the mornings of Day 1 and Day 10.
16127542|NCT01953835|Drug|Rosuvastatin|GSK2586184 new formulation without poloxamer is a white film coated round biconvex 200 mg oral tablet. In cohort B, it is to be administered at 400 mg (200 mg x 2 tablets) single dose once after standard breakfast and once after overnight fasting, either on Day 1, 4 and 7 according to the treatment sequence, each separated by a 3-day washout period.
16127543|NCT01953835|Drug|GSK2586184 new formulation|GSK2586184 new formulation without poloxamer is a white film coated round biconvex 200 mg oral tablet. In cohort B, it is to be administered at 400 mg (200 mg x 2 tablets) single dose once after standard breakfast and once after overnight fasting, either on Day 1, 4 and 7 according to the treatment sequence, each separated by a 3-day washout period.
16127544|NCT01953822|Other|Data collection|Data collection from an existing electronic healthcare databases - Clinical Practice Research Datalink (CPRD) GOLD.
16127545|NCT01953809|Drug|GSK1322322|Oral tablets with unit dose strength of 500mg and dose level of 1500mg (3 x 500mg) for twice a day administration for 7 days in treatment phase
16127546|NCT01953809|Drug|EE/NE|Oral contraceptive tablet containing 0.035mg EE and 1mg NE for once daily administration for 21 days in run-in phase and 21 days in treatment phase
16127547|NCT01953809|Drug|GSK1322322 Placebo|GSK1322322 matching placebo tablets for twice a day administration (3 tablets each time) for 7 days in treatment period.
16127548|NCT01953809|Drug|EE/NE Placebo|EE/NE matching placebo tablet for once daily administration for 7 days in run-in phase.
16127549|NCT01953796|Drug|clomiphene|For both protocols follow up of the follicular growth has been made by frequent tvUSS monitoring, which have the advantage of providing direct information about the size and number of follicle and measurement of endometrial thickness during clomiphene medication.
16127550|NCT01953783|Drug|IXAZOMIB|"Part A: Ixazomib 4.1 mg containing approximately 500-nCi [14C]-ixazomib, solution, orally on Day 1 and ixazomib 4 mg, capsule, orally on Days 14 and 21.
~Part B: Ixazomib 4 mg, capsule, orally, once weekly, on Days 1, 8 and 15 in 28-day cycles until disease progression or unacceptable toxicity."
16127551|NCT01953770|Drug|PEG-L-asparaginase ind|1,000 U/m2 on day 3 of induction therapy, intravenously, in 200 ml of saline, during 1 hour
16127552|NCT01953770|Drug|PEG-L-asparaginase cons|1,000 U/m2 intravenously, in 200 ml of saline, during 1 hour, 24 hours after methotrexate on weeks 7, 9, and 11 - days 44, 58, and 72 (phase S1), weeks 15, 17, and 19 - days 100, 114, 128 (phase S2), weeks 23, 25, and 27 - days 156, 170, 184 (phase S3).
16127599|NCT01953484|Other|Change in extracorporeal carbon dioxide removal|
16127600|NCT01953471|Other|Allergic rhinitis|Questionnaire
16127553|NCT01953770|Drug|E.coli L-asparaginase|E.coli L-asparaginase (asparaginase medac) 5,000 U/m2 intramuscularly weekly, 24 hours after methotrexate dose, from week 7 to week 12 - days 44, 51, 58. 65, 72, 79 (phase S1), from week 15 to week 20 - days 100, 107, 114, 121, 128, 135 (phase S2), from week 23 to week 28 - days 156, 163, 170, 177, 184, 191 (phase S3).
16127554|NCT01953770|Drug|High-dose Methotrexate|2,000 mg/m2 per 24 hours is given at days 43, 57, and 71 (weeks 7, 9, and 11). 1/5 of the total dose is given as slow intravenous bolus over 3-5 minutes. 4/5 of the total dose of methotrexate is injected as continuous 24 hours infusion.
16127555|NCT01953770|Drug|Low-dose Methotrexate|30 mg/м2 is given intramuscularly 1 time weekly - days 43, 50, 57, 64, 71, and 78 (weeks 7, 8, 9, 10, 11, and 12).
16127556|NCT01953770|Drug|Triple intrathecal therapy|Intrathecal injection of 3 drugs is additionally given three times during phase S-2 (weeks 15, 17, and 19 - days 99, 113, and 127), and three times during phase S-3 (weeks 23, 25, and 27 - days 155, 169, and 183).
16127557|NCT01953770|Radiation|Cranial irradiation|12 Gy cranial irradiation is conducted at weeks 31-32 of the Protocol in patients >3 years of age
16127558|NCT01953770|Drug|Daunorubicin|Daunorubicin at a dose of 45 mg/m2 i.v. for 6 hours on day 8 of induction therapy
16127559|NCT01953757|Other|Vegan diet and vitamin B12 supplement|A low-fat, vegan diet (no meat, fish, eggs or dairy products) and a vitamin B12 supplement in the form of 2000mcg of methylcobalamin
16127560|NCT01953757|Dietary Supplement|Vitamin B12 supplement|A daily vitamin B12 supplement in the form of 2000mcg of methylcobalamin
16127561|NCT01953744|Drug|Fluconazole|Fluconazole is presented in 150mg capsules and will be administered by oral route at a dosage of 6-8mg/kg/day during 28 days.
16127562|NCT01953744|Drug|Meglumine Antimoniate|Meglumine Antimoniate will be administered as the standard treatment for cutaneous leishmaniasis by intravenous route at a dosage of 20mg/kg/day, during 20 days.
16127563|NCT01953731|Drug|Palbociclib|"In period 1, patients will receive a single 125mg oral dose of palbociclib alone. Subjects will undergo palbociclib pharmacokinetic sampling at prespecified time points up to 120 hours post palbociclib dose.
~In period 2, subjects will receive 12 daily oral doses of 600mg of rifampin and a single 125mg oral dose of palbociclib on day 8. Subjects will undergo palbociclib pharmacokinetic sampling at prespecified time points up to 120 hours post palbociclib dose."
16127564|NCT01953731|Drug|Rifampin|In period 2, subjects will receive 12 daily oral doses of 600mg of rifampin and a single 125mg oral dose of palbociclib on day 8. Subjects will undergo palbociclib pharmacokinetic sampling at prespecified time points up to 120 hours post palbociclib dose.
16127565|NCT01953705|Drug|Omega 3 PUFA|fish oil concentrate standardized to long chain n-3 PUFA content
16127566|NCT01953705|Drug|Placebo|
16127567|NCT01953692|Biological|Pembrolizumab|IV infusion
16127568|NCT01953692|Drug|Lenalidomide 20 mg|oral capsule
16127569|NCT01953692|Drug|Lenalidomide 25 mg|oral capsule
16127570|NCT01953679|Drug|Ulipristal Acetate|
16127571|NCT01953666|Other|Rehabilitation program|"Rehabilitation program with an occupational therpasit
~3 training sessions (one hour) per week for a month (12 sessions)"
16127572|NCT01953666|Other|Self - Training at home|Only instructions for a self - training at home
16127573|NCT01953653|Behavioral|Structured daily diary|The intervention is a structured daily diary to describe fluctuations in key psychological and behavioral variables impacting daily risk behavior among HIV-positive young men who have sex with men (YMSM), aged 16 to 24 years old who engage in substance use and sexual risk behaviors.
16127574|NCT01953640|Other|Laboratory Biomarker Analysis|Correlative studies
16127575|NCT01953640|Other|Quality-of-Life Assessment|Ancillary studies
16127576|NCT01953627|Procedure|Surgical procedure with the system Kymerax|
16127577|NCT01953627|Device|The system Kymerax|
16127578|NCT01953614|Other|Chiropractic adjustment|
16127579|NCT01953614|Other|Sham adjustment|
16127580|NCT01953601|Drug|Verubecestat 12 mg (Parts 1 and 2)|Verubecestat 12 mg oral tablet, given once daily.
16127581|NCT01953601|Drug|Verubecestat 40 mg (Parts 1 and 2)|Verubecestat 40 mg oral tablet, given once daily. Verubecestat 40 mg given to participants in Arm C continuing to study Part 2.
16127582|NCT01953601|Other|Placebo (Part 1)|Placebo matching verubecestat, given once daily as an oral tablet.
16127583|NCT01953588|Drug|fulvestrant|Fulvestrant 500 mg IM
16127584|NCT01953588|Drug|anastrozole|Anastrozole 1 mg oral tablet
16127585|NCT01953575|Device|Mucosal Impedance|A tiny tube will be placed through the endoscope into the esophagus. 5 cm above where the stomach and esophagus meet for 5 seconds. At 10 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds. And at 20 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds.
16127586|NCT01953575|Procedure|Upper Endoscopy|Esophagogastroduodenoscopy, also called by various other names, is a diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum.
16127587|NCT01953549|Procedure|physical fitness training|
16127588|NCT01953549|Procedure|relaxation|
16127589|NCT01953536|Drug|Vintafolide 2.5 mg|During treatment, participants receive IV vintafolide 2.5 mg.
16127590|NCT01953536|Drug|Paclitaxel 80 mg/m^2|During treatment, participants receive IV paclitaxel 80 mg/m^2.
16127591|NCT01953536|Drug|Etarfolatide|During screening and prior to screening CT scan, participants receive an IV injection of 0.1 mg etarfolatide radiolabeled with 20 to 25 milliCuries of technetium-99m.
16127592|NCT01953536|Drug|Folic acid|During screening and prior to etarfolatide injection and screening CT scan, participants receive an IV injection of 0.5 mg folic acid.
16127593|NCT01953536|Drug|Premedication for Paclitaxel|During treatment, participants receive dexamethasone 20 mg orally 12 to 6 hours prior to paclitaxel; OR promethazine 25 mg or 50 mg IV 30 to 60 minutes prior to paclitaxel; OR cimetidine 300 mg IV or ranitidine 50 mg IV 30 to 60 minutes prior to paclitaxel.
16127594|NCT01953523|Procedure|Administration of autologous adipose derived SVF|Intra-venous, intra-articular, and soft tissue injection delivery of SVF
16127595|NCT01953510|Biological|PCV10|PCV10 includes serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F and protein D is the main carrier protein
16127596|NCT01953510|Biological|PCV13|PCV13 includes serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F, individually linked to non-toxic diphtheria CRM197 carrier protein
16127597|NCT01953497|Drug|URC102|
16127598|NCT01953497|Drug|Placebo|
16127603|NCT01953432|Drug|Doxazosin|Doxazosin is initiated at 2 mg/wk, and titrated up to a maximum of 8 mg/day over approximately 4 weeks. Participants will be maintained on 8mg daily dosing until week 13. The subjects will undergo the discontinuation from the study medication during weeks 14 -15.
16127604|NCT01953432|Drug|Placebo|Matched placebo daily dosing
16127605|NCT01953419|Drug|Pemetrexed disodium|Patients received Pemetrexed disodium 500mg/m2 every 21 days until the presence of progressive disease or unacceptable toxicity.Patients were instructed to take oral folic acid 400 mg daily beginning 5 days before the first therapy and until the final therapy. Patients received vitamin B12 before the first cycle of Pemetrexed and every three cycles of chemotherapy.
16127606|NCT01953406|Drug|5-fluorouracil|5-fluorouracin 15mg/kg/day D1-6 civ till progression, every 4 weeks
16127607|NCT01953406|Drug|Mitomycin|Mitomycin 4mg/day iv push D1,4 till progression, every 4 weeks
16127608|NCT01953393|Other|Low-dose TNF-alpha|
16127609|NCT01953380|Behavioral|extended information|
16127610|NCT01953367|Drug|Vantobra (tobramycin)|Inhalation
16127611|NCT01953367|Drug|TOBI (tobramycin)|Inhalation
16127612|NCT01953354|Biological|Trichuris suis ova (TSO)|Six doses of TSO orally over a ten-week period (e.g., every 2 weeks x 10 weeks for a total of 6 total doses)
16127613|NCT01953354|Biological|Placebo|Six doses of TSO placebo orally over a ten-week period (e.g., every 2 weeks x 10 weeks for a total of 6 total doses)
16127614|NCT01953341|Drug|AMG 333|Oral administration available in varying dose strength.
16127615|NCT01953341|Drug|Placebo|Placebo containing no active drug
16127616|NCT01953328|Drug|Atorvastatin|Administered orally once a day
16127617|NCT01953328|Biological|Evolocumab|Administered by subcutaneous injection
16127618|NCT01953328|Other|Placebo to Evolocumab|Administered by subcutaneous injection
16127619|NCT01953315|Biological|Autologous Muscle Progenitor Cells|Autologous MPCs, administered via a single, direct injection into the bladder neck sphincter region
16127620|NCT01953302|Procedure|"modified open mesh technique"|We positioned mesh intraperitoneally so it can provide adequate mechanical support to the weakened abdominal wall. We also preserved hernia sack to conceal the mesh.
16127621|NCT01953276|Device|Serial Electrocardiograms|All participants will have serial electrocardiograms performed.
16127622|NCT01953263|Other|Autologous Muscle Fiber Fragments|Autologous muscle fiber fragments administered via a single direct injection into the bladder neck sphincter region
16127623|NCT01953237|Behavioral|MedActive|Participants randomized to the MedActive condition will complete a 1-hour training session on MedActive, which will include ascertaining their antipsychotic administration schedule that will be pre-programmed into the application along with other personalized features. Each participate will be asked to use the medActive application over the following three months. All participants randomized to this condition will also have their antipsychotic medication adherence assessed over the 3-month period.
16127624|NCT01953237|Device|Smartphone|
16127625|NCT01953224|Behavioral|Game-based intervention|"Investigators will provide participants with a smartphone and required accessories (gift card for downloading the game application and music, headphones, armband). The game, Zombies, Run! encourages walking/jogging by playing music interspersed with a continuous narrative. Periodic zombie chases encourage brief interval training. Participants will set goals to increase their activity and receive weekly brief counseling phone calls to provide feedback."
16127626|NCT01953224|Device|Smartphone|
16127627|NCT01953211|Drug|combined oral contraceptives|
16127628|NCT01953198|Other|Hypobaric hypoxia|Subjects are exposed to hypobaric hypoxia in the context of a high altitude expedition.
16127629|NCT01953185|Other|Sham manual diaphragm release technique|For this group, light touch at the same anatomical points was done without exerting pressure or traction. Positioning and duration were identical to the IG to perform the sham protocol (Licciardone & Russo, 2006).
16127630|NCT01953185|Other|The manual diaphragm release technique|To perform the technique the volunteer was placed in supine position with limbs relaxed. Positioned behind the head of the volunteer, the therapist performed manual contact (pisiform, ulnar edge and the last three fingers) with the underside of the costal cartilage of the 7th, 8th, 9th and 10th rib, and guiding forearms toward the shoulders of the corresponding side. In the inspiratory phase, the therapist gently pulled the points of contact with both hands, in the direction of the head, yet slightly lateral, accompanying the elevation movement of the ribs. During exhalation, the therapist deepened contact toward the inner costal, maintaining resistance throughout the inspiratory phase. In the breaths following, the therapist sought to gain traction and smooth increase in the deepening of contacts. This maneuver was performed in two sets of ten deep breaths, with a one minute interval between them.
16127631|NCT01953172|Dietary Supplement|AMP-886|AMP886 (alpha-tocotrienol) encapsulated in gelatin capsules
16127632|NCT01953172|Other|Placebo|Placebo
16127633|NCT01953159|Other|Blood Collection|
16127634|NCT01953159|Other|Patient Questionnaires|
16127635|NCT01953133|Behavioral|Couples Counselling Sessions|4 couples' counseling sessions focusing on problem solving and communication skills for the couple. Based upon the Prevention and Relationship Enhancement Program (PREP.)
16127636|NCT01953120|Drug|Belatacept|Subjects will receive intravenous belatacept at 5mg/kg every other week starting from day 1 and continuing with weeks 2, 4, 6, and 8, and then monthly at months 3, 4, 5, and 6. At month 6 patients may elect to continue for an additional six-month period of belatacept administration.
16127637|NCT01953107|Other|Oral Ferrous Fumarate|
16127638|NCT01953107|Other|Placebo|
16127639|NCT01953094|Procedure|Screening Anal Pap Smear - No High Resolution Anoscopy|
16127640|NCT01953094|Procedure|Screening Anal Pap Smear - With High Resolution Anoscopy|
16127641|NCT01953081|Drug|TD-8954|
16127642|NCT01953081|Drug|Metoclopramide|
16127643|NCT01953055|Radiation|Stereotactic ablative radiotherapy|
16127644|NCT01953042|Behavioral|Psychoeducation|4 educational sessions covering information on diagnosis, treatment, available resources and self care for OCD and OCD Spectrum Disorders
16127645|NCT01953029|Procedure|cardiac imajing|Cardiac MRI
16127646|NCT01953003|Drug|vinflunine|intravenous administration day 1 once every 3 weeks, 280 mg/m²
16127647|NCT01953003|Drug|Capecitabine|Arm A : 1650 mg/m² Arm B : 2500 mg/m²
16128309|NCT01948037|Other|hydrotherapy|30-minutes/per day,for 4weeks
16127648|NCT01952990|Drug|Tetracaine HCl 3% and Oxymetazoline HCl 0.05%|1 spray device is 0.2mL (200 μL) in volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl. Subjects receiving the 100 μL dose will receive half of the contents of one device using a dose divider. Subjects receiving the 200 μL dose will first receive half of the contents of one device using a dose divider and then 4 minutes later will receive the 2nd half by removing the dose divider. Subjects receiving the 400 μL dose will first receive the entire contents of one device and then 4 minutes later will receive the contents of a 2nd device.
16127649|NCT01952977|Dietary Supplement|Test breakfast|
16127650|NCT01952964|Other|JUC spray dressing|"Intervention group Care of Tenckhoff catheter exit site using spray dressing. The detailed procedures will be introduced by the nurse according to the protocol of the unit. Please refer to Appendix III for details.
~Skin test with JUC spray will be carried out prior to the usage of JUC spray dressing for caring the exit site. For the first three days after patient has been discharged, study team members will perform telephone follow up. Patients are reminded to report for signs and symptoms of infection or physical damage of catheter noted. A routine follow up at the Renal Unit will be arranged at eight weeks intervals."
16127651|NCT01952951|Drug|Capecitabine Oxaliplatin|after completion of chemoradiation, two cycles of capecitabine (850mg/m2 twice daily from D1 evening to D15 morning) and oxaliplatin (100mg/m2 on D1) will be administered every 3 weeks.
16127652|NCT01952951|Radiation|pelvic radiation capecitabine 5-fluorouracil|50.4Gy of pelvic radiation with capecitabine or 5-fluorouracil
16127653|NCT01952938|Procedure|LINK SL versus EnduRo|
16127654|NCT01952925|Procedure|Renal Artery denervation|RA denervation performed as part of afib ablation procedure
16127655|NCT01952912|Procedure|PkEP|
16127656|NCT01952912|Procedure|OP|
16127657|NCT01952886|Drug|Granisetron|
16127658|NCT01952886|Drug|Ondansetron|
16127659|NCT01952873|Other|Prolonged inflation|Prolonged inflation will be performed at high pressure(16 atm)and maintained for 30 sec with <0.3 atm drop during that period.
16127660|NCT01952873|Other|Rapid inflation|The rapid inflation method will consist of reaching an operator determined high-pressure (16 atm) with the stent-deployment balloon and maintaining it the duration of time determined by the operator but <30 sec if the balloon is fully inflated and longer only if the balloon requires a longer duration to become fully inflated.
16127661|NCT01952860|Other|Hatha Yoga|18 sessions of Hatha yoga over the course of radiation therapy. Each 45 to 60 minute session guided by an instructor. Participant should attend each session together with their caregiving partner. Some sessions videotaped. At first session, participant given a CD and instructions for practicing Hatha yoga at home.
16127662|NCT01952860|Behavioral|Questionnaires|Questionnaire completion at baseline, during radiation therapy, and at completion of radiation therapy.
16127663|NCT01952847|Other|Placebo|"mTOR Inhibitor Patient Group: Participants receive placebo beginning on Day 1 of an mTOR inhibitor based therapy. Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy.
~Radiation Therapy to Esophagus Patient Group - Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times."
16127664|NCT01952847|Drug|Glutamine|"mTOR Inhibitor Patient Group - Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy.
~Radiation Therapy to Esophagus Patient Group - Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day radiation therapy to the esophagus received. Participant to swallow the drink in small amounts several times."
16127665|NCT01952847|Behavioral|Questionnaires|"Questionnaire completion for mTOR Inhibitor Patient Group: At baseline, Day 1 of cycle 2 and beyond, after 6 months of chemotherapy, and at end of study visit.
~Questionnaire completion for Radiation Therapy to Esophagus Patient Group: At baseline, Week 3, 4, 5, and 7 of radiation, and at end of study visit."
16127666|NCT01952834|Dietary Supplement|GoodBelly Probiotic|GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
16127667|NCT01952834|Drug|Vancomycin|GoodBelly Probiotic 2.7 oz Daily x 6 weeks. Followed by a 4 week wash out period and then, Vancomycin, a non absorbed antibiotic administered (250 mg four times daily) orally for 10 days
16127668|NCT01952821|Other|Six-Minute Walk Test|
16127669|NCT01952821|Other|10-Meter Walk Test|
16127670|NCT01952821|Other|30-Second Chair Stand|
16127671|NCT01952821|Other|Linear Analog Scale of Function|
16127672|NCT01952821|Other|Modified Brief Fatigue Inventory|
16127673|NCT01952821|Other|FACIT-Fatigue|
16127674|NCT01952808|Behavioral|Face-to-face family mentoring and education sessions|A total of 13 home visits will be completed over a 6 month period. In addition to an introductory/orientation visit, 12 home visits will consist of family mentoring/educational sessions focused on physical activity and healthy nutrition.
16127675|NCT01952808|Behavioral|Telephone follow-up|During months 7-12, a total of up to 12 phone calls will be completed. Follow-up calls will consist of a progress report from families on physical activity and healthy diet progress/goals, along with brief content follow-up and re-enforcement points from the 12 intervention sessions.
16127676|NCT01952795|Behavioral|Diet and exercise|Total caloric intake aimed at maintaining a diet with> 50% of the caloric content in the form of carbohydrates, less than 10% in the form of saturated fats and 20% from monounsaturated / polyunsaturated (if applicable, up to 25% fat monounsaturated), less than 300 mg / day of dietary cholesterol and about 1.0 g of protein / kg ideal body weight / day.
16127677|NCT01952782|Drug|Kisspeptin 112-121|Subjects will receive up to 10 intravenous doses of kisspeptin 112-121
16127678|NCT01952782|Drug|Naloxone|Subjects will receive one intravenous dose of naloxone followed by an intravenous infusion of naloxone.
16127679|NCT01952782|Drug|Gonadotropin Releasing Hormone (GnRH)|Subjects will receive up to 10 doses of intravenous Gonadotropin Releasing Hormone (GnRH)
16127718|NCT01952431|Device|Total Lung Capacity (TLC) testing|Comparison of TLC results
16128310|NCT01948037|Other|hydrotherapy|30-minutes/per day;4weeks
16127680|NCT01952769|Biological|MDV9300|"The study will be done in the following manner:
~Evaluation of MDV9300 and radiation-
~Cohort A-3 patients: first dose of MDV9300 3mg/m2 .If no toxicity over grade 2-second dose and on -6 mg/kg.
~Cohort B -3 patiens: if no toxicity >grade 2 seen in cohort A- start dose will be 6 mg/kg If toxicity> grade 2 in 2 patients or more on a dose of 3 mg/kg the dose in cohort B will be 1 mg/kg during irradiation If toxicity> grade 2 in 2 patients or more on a dose of 1 mg/kg no further concurrent MDV9300 and radiation will be given
~Evaluation of MDV9300 and cyclophosphamide
~After completion of the first phase (6 patients) a cohort of 15 patients will be accrued. The treatment protocol of this cohort will be as follows:
~Following radiation completion , and after recovery from treatment adverse events of grade 2 and higher, the patients will be started on concurrent biweekly MDV9300 and weekly cyclophosphamide 200mg/m2"
16127681|NCT01952756|Drug|Cilostazol|One tablet (100 mg) twice per day for 12 weeks
16127682|NCT01952756|Drug|Dummy Placebo|One tablet twice per day for 12 weeks
16127683|NCT01952743|Procedure|AF ablation with Renal Denervation|Pulmonary vein isolation (PVI) is performed as per operator preference by previously described techniques. Both mapping and ablation are performed under general anesthesia. The use of standard electrophysiology ablation catheter to perform renal artery ablation in hypertensive patients has been previously described. UP to 2 minutes of RF energy (10W with irrigation flow of 17 ml/min) are delivered at each location and up to 6 lesions for each artery on the longitudinal and rotational axis. Renal denervation is performed on both vascular pedicles after clinical AF ablation in patients assigned to the intervention arm.
16127684|NCT01952743|Procedure|AF ablation alone|Pulmonary vein isolation (PVI) is performed as per operator preference by previously described techniques.
16127685|NCT01952730|Biological|GVAX|
16127686|NCT01952704|Behavioral|Aerobic exercise|
16127687|NCT01952704|Behavioral|Placebo control|Non-aerobic stretching sessions will be conducted 3x/week for 30 minutes over 12 weeks.
16127688|NCT01952691|Device|kinesiotaping|correction method was used to align hallux.
16127689|NCT01952678|Other|DaTscan™ - Non-Caucasian Participants|Participants who previously administered DaTscan™ and had undergone SPECT imaging of the brain per local practice at each institution.
16127690|NCT01952678|Other|DaTscan™ - Caucasian Participants|Participants who previously administered DaTscan™ and had undergone SPECT imaging of the brain per local practice at each institution.
16127691|NCT01952665|Device|comfilcon A|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
16127692|NCT01952665|Device|lotrafilcon B|Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating schedule for the second pair without a washout period.
16127693|NCT01952652|Drug|Group N:Naproxen sodium|drug will be given 60 minutes before surgery
16127694|NCT01952652|Drug|Group NC :naproxen sodium codeine phosphate|drug will be given 60 minutes before surgery
16127695|NCT01952639|Dietary Supplement|protein type and amount|Subjects will stay in a supine position and consume a test beverage containing different amounts ans types of protein
16127696|NCT01952626|Drug|Ondansetron|intravenous injection
16127697|NCT01952626|Drug|Palonosetron|intravenous injection
16127698|NCT01952613|Device|FES|In phase 1, five subjects (randomly chosen) will be provided the FES device and instructed to use it for ambulation for the 6 months. At the baseline visit, gait data will be collected from this group. On the 6 month follow up visit, same data collection procedure will be performed and the devices will be collected back from the subjects. After performing quality check on these devices, phase 2 of the data collection will start by providing the devices to the other five subjects and their baseline data will be collected.
16127699|NCT01952587|Biological|A peripheral blood sample|A peripheral blood sample will be collected from HIV-infected subjects and healthy control to measure TLR-7 SNP frequency by PCR. IFN-alpha production from pDCs after HIV-1 RNA sensing by TLR7 will also be assessed
16127700|NCT01952574|Drug|Erenumab|Administered by study site staff once a month (QM) as a subcutaneous injection
16127701|NCT01952574|Drug|Placebo|Administered by study site staff once a month (QM) as a subcutaneous injection
16127702|NCT01952574|Drug|Erenumab PFS|Erenumab supplied in a single-use prefilled syringe for self-administration in the CHU substudy
16127703|NCT01952574|Drug|Erenumab AI/Pen|Erenumab supplied in a single-use autoinjector/pen for self-administration in the CHU substudy
16127704|NCT01952561|Drug|dapivirine ring|
16127705|NCT01952548|Drug|K-312|
16127706|NCT01952548|Drug|Placebo|
16127707|NCT01952535|Drug|HMS5552|
16127708|NCT01952535|Drug|Placebo|
16127709|NCT01952522|Behavioral|Weighted brace|People will have to wear all the day additional weights (between 2 and 4 kilograms) at the nonparetic ankle during 3 months
16127710|NCT01952522|Behavioral|Non weighted brace|People will be given a brace with no weight they will have to wear all the day during three months.
16127711|NCT01952496|Other|Assisted Standing Treatment Program|"Assisted standing treatment program will include at least 2 hours a day, 5 days a week (a total of at least 10 hours a week) for a period of ~9 months.
~Arm: Force-measuring platform"
16127712|NCT01952470|Drug|Dornase Alfa|Once daily, 2.5ml inhaled dornase alfa (evening if able) with inhalational breathing routine (IBR). IBR consists of 4 slow deep breaths followed by 6 relaxed breaths, repeated until nebuliser is complete, coughing when the patient feels the need to expectorate. The patient will be instructed to sit in an upright position with upper limb support as able.
16127713|NCT01952470|Drug|Isotonic Saline.|Once daily, 5ml inhaled 0.9% normal saline (evening if able) with inhalational breathing routine (IBR). IBR consists of 4 slow deep breaths followed by 6 relaxed breaths, repeated until nebuliser is complete, coughing when the patient feels the need to expectorate. The patient will be instructed to sit in an upright position with upper limb support as able.
16127714|NCT01952457|Device|Zilver PTX|
16127715|NCT01952457|Device|prosthetic bypass|
16127716|NCT01952444|Biological|ETI-204|A single IV infusion of 16 mg/kg ETI-204 over 90 minutes on Day 1
16127717|NCT01952444|Drug|Ciprofloxacin|A single IV Infusion of 400 mg Ciprofloxacin over 60 minutes immediately following the infusion of ETI-204 on Day 1, followed by oral Ciprofloxacin (750 mg every 12 hours) on Days 2-8, and a final oral dose on the morning of Day 9.
16127719|NCT01952418|Device|Monitor size|"Subjects will be randomized to perform their colonoscopy procedures while viewing a large (32) video monitor or the standard (24) video monitor."
16127720|NCT01952405|Behavioral|Dialectical behavior therapy (DBT)|Dialectical behavior therapy (DBT), developed by Marsha Linehan, has gained widespread popularity as a treatment for BPD, and its efficacy has been demonstrated in several trials.
16127721|NCT01952353|Procedure|Preoprative TACE|
16127722|NCT01952353|Procedure|Liver resection plus Thrombectomy|Liver resection plus Thrombectomy
16127723|NCT01952340|Dietary Supplement|Flaxseed|Milled flaxseed
16127724|NCT01952340|Dietary Supplement|Placebo|Wheat germ/wheat bran and mixed dietary oils
16127725|NCT01952327|Device|The pleurapump system|Implantation of the pleurapump system
16127726|NCT01952314|Drug|Naftopidil 75mg|naftopidil 75mg 1T qd hs
16127727|NCT01952314|Drug|Placebo for Naftopidil|Placebo 1T qd hs
16127728|NCT01952314|Drug|Standard treatment|Aceclofenac 100mg or tramadol37.5mg/acetaminophen 325mg on demand
16127729|NCT01952301|Device|Xenogeneic Collagen Matrix|A type I and III porcine collagen matrix, as cleared by FDA (K012423)
16127730|NCT01952301|Device|Free Gingival Graft|Autogenous, full-thickness soft tissue graft harvested from patient's palate.
16127733|NCT01952275|Procedure|Collection of biological samples|
16127734|NCT01952262|Other|diaphragm ultrasound|we'll perform diaphragm ultrasound in ICU critically ill patients
16127735|NCT01952249|Drug|Demcizumab|administered intravenously
16127736|NCT01952249|Drug|Taxol|administered intravenously
16127737|NCT01952236|Behavioral|Web+Mobile|We propose to evaluate the efficacy and acceptability of a Web+Mobile tobacco cessation intervention in a 2-arm Randomized Controlled Trial with 1,271 adult study participants who agree to quit smoking within a pre-specified amount of time. Participants who meet eligibility criteria will be randomly assigned to either (a) an enhanced Web Only intervention or (b) an enhanced Web+Mobile intervention.
16127738|NCT01952236|Behavioral|Web Only|A Web-based PC-delivered best practices smoking cessation intervention.
16127739|NCT01952223|Drug|Cabazitaxel|Cabazitaxel administered at 25 mg/m² as a 1 hour intravenous infusion every 3 weeks (1 cycle = 21 days) for 4 cycles
16127740|NCT01952223|Radiation|Pelvic radiotherapy|"Prostate+pelvic RT (2 Gy fractions, 5 times per week):
~Phase 1: pelvic radiotherapy (prostate, seminal vesicles, ilio-obturator, presacral lymph nodes) (46 or 50 Gy according to the center)
~Phase 2: prostate-only boost (EBRT) up to 74-78 Gy"
16127741|NCT01952223|Radiation|prostate radiotherapy|"Prostate-only RT (2 Gy fractions, 5 times per week):
~Phase 1: prostate + seminal vesicle radiotherapy (46 or 50 Gy according to the center)
~Phase 2: prostate-only boost (EBRT) up to 74-78 Gy"
16127742|NCT01952210|Behavioral|nutritional consultation and exercise program|The protocol involved 20-30 minutes of individual-based nutrition consultation every week during the 8-week chemoradiation therapy. The exercise program consisted of upper extremity muscle training and walking exercise at 45%-65% of maximal heart rate reserve, 3 times per week, 20-30 minutes per session.
16127743|NCT01952210|Behavioral|usual care|pre-CCRT education included self-care during CCRT and body weight maintenance
16127744|NCT01952197|Other|Passive Leg Raise|The intervention is made on all adult patients receiving CPR by the ambulance crew. The leg raise is performed during the first minutes of CPR (limit 5 min) and will continue as long as the patients receive chest compression. In Spain the patient is immediate randomized by envelope. If the patient is randomized to PLR, the ambulance crews use a special folding stool that allows the legs to be raised about 20 degrees.
16127745|NCT01952184|Device|CBSvit HS device|closed vitrification with closed storage
16127746|NCT01952184|Device|Cryotop SC device|open vitrification with closed storage
16127747|NCT01952145|Drug|insulin degludec/liraglutide|Insulin degludec/liraglutide is injected subcutaneously s.c. (under the skin) once daily (OD). Dose individually adjusted. Subjects should continue their pre-trial treatment with metformin.
16127748|NCT01952145|Drug|insulin glargine|Insulin glargine is injected subcutaneously s.c. (under the skin) once daily (OD). Dose individually adjusted. Subjects should continue their pre-trial treatment with metformin.
16127749|NCT01952132|Drug|OMS643762|
16127750|NCT01952132|Drug|Placebo|
16127751|NCT01952119|Other|Secure message reminder|Single secure message reminder asking subjects to schedule an appointment with their provider or make a nurse visit to follow-up on their blood pressure
16127752|NCT01952106|Other|play computer game|
16127753|NCT01952093|Behavioral|Home-based intervention program|The intervention had been done in the previous intervention study. The intervention included in-hospital and after-discharge service. After-discharge intervention performed at 0, 1, 2, 4, 6, 9, 12 months of age at the home.
16127754|NCT01952093|Behavioral|Clinic-based intervention program|The intervention had been done in the previous intervention study. The intervention included in-hospital and after-discharge service. After-discharge intervention performed at 0, 1, 2, 4, 6, 9, 12 months of age at the clinic.
16127755|NCT01952080|Drug|teduglutide|Open label intervention. Each subject will be assigned to receive 0.0125, 0.025, or 0.05 mg/kg/day for the duration of the study
16127756|NCT01952067|Procedure|line-to-line reaming and cementing technique|
16127757|NCT01952067|Procedure|standard over-reaming with 2 broach sizes|
16127758|NCT01952054|Drug|Denosumab|120 mg subcutaneously on Day 1 of every 28 day cycle.
16127759|NCT01952041|Behavioral|Device: Smartphone|
16127760|NCT01952041|Behavioral|Treatment as usual|
16127761|NCT01952015|Biological|Secukinumab|Secukinumab (AIN457) 150 mg, provided in a 1 mL prefilled syringe (one syringe for 150 mg dose, two syringes for the 300 mg dose).
16127762|NCT01952002|Other|Inspiratory Muscle Training|Each session The session itself consisted of the following: two sets of 15 breathe cycles without removing the breathing promoter from the mouth and with the aid of a nose clip and 1-minute interval between sets. For training, we used the breathing promoters Power Breathe® Plus Light and Medium Resistance, possessing 10 levels of load gradation ranging from 17 to 186 cm H2O, which were adjusted for each patient and allowed for the individualized prescription of IMT
16127763|NCT01951989|Drug|Imiglucérase (drug) pharmacokinetics|
16128311|NCT01948024|Drug|SAPHRIS|10 mg BID sublingual tablet
16127764|NCT01951976|Other|Questionnaires|Participants will be asked to complete a set of questionnaires about their health and well-being on two occasions (baseline and follow-up). Each set of questionnaires will take about 45 minutes to complete.
16127765|NCT01951976|Other|Yoga Classes|Iyengar yoga is a traditional form of Hatha yoga that has been used previously to address quality of life issues in women with breast cancer. Iyengar yoga classes for 90 minutes twice per week for 12 weeks (total of 24 classes).
16127766|NCT01951963|Drug|Ketamine|
16127767|NCT01951963|Drug|Morphine|
16127768|NCT01951950|Drug|Nicardipine|
16127769|NCT01951950|Drug|Esmolol|
16127770|NCT01951937|Dietary Supplement|Fish Meals|Meals containing salmon
16127771|NCT01951937|Dietary Supplement|Placebo|No fish meals
16127772|NCT01951924|Drug|Biological : I10E (Human normal Immunoglobulin for intravenous administration 100mg/mL)|
16127773|NCT01951924|Drug|Biological: Kiovig® (Human normal Immunoglobulin for intravenous administration 100mg/mL)|
16127774|NCT01951911|Drug|Ketamine|Patients will receive either ketamine as subcutaneous infusion or placebo as subcutaneous infusion. The results will be compared with each other.
16127775|NCT01951911|Drug|Placebo|
16127776|NCT01951898|Drug|Montelukast|10mg/day, once a daily after dinner, for 28dyas
16127777|NCT01951885|Drug|tacrolimus|Tacrolimus 0.03 mg/kg/day beginning day -1 or tacrolimus 0.03mg/kg/dose BID orally beginning on day -3. If Tac is administered intravenously, it will be given over 24 hours and will be converted to oral administration 2 times a day when the patient has engrafted and/or can tolerate oral medication. Levels of Tac will be obtained to maintain a recommended target serum level of 5-12 ng/mL
16127778|NCT01951885|Drug|methotrexate|MTX 15mg/m2 IV on day +1, followed by 10mg/m2 on day +3, +6, +11. If patient < 10 kg then MTX will be given at 0.5 mg/kg IV on day +1. Then MTX will be given at 0.33 mg/kg on days +3, +6 and +11.
16127779|NCT01951885|Drug|Mycophenolate mofetil|Patients will receive Mycophenolate beginning on day +1. Patients >40 kg will receive Mycophenolate 1000 mg twice a day. Mycophenolate should be given orally twice a day. IV formulation may be used if the patient cannot tolerate oral route. Patients < 40 kg will receive MMF 45 mg/kg/day (15 mg/kg three times a day). MMF may be given orally or intravenously as per institutional protocol
16127780|NCT01951885|Drug|Methotrexate (low dose)|MTX 5mg/m2 IV on day +1, +3, +6. If patient<10 kg MTX will be given at 0.17 mg/kg on day +1, +3, and +6.
16127781|NCT01951872|Behavioral|Manual-based treatment for caffeine dependence|Participants will meet with a counselor to discuss plans for caffeine reduction or cessation, and they will receive a manual-based treatment to help guide them through caffeine reduction or cessation.
16127782|NCT01951859|Other|Neuropathy/Ulcer Homeopathic topical cream|This is a GRAS topical agent containing homeopathic ingredients
16127783|NCT01951846|Drug|BIBF 1120|
16127784|NCT01951833|Device|EasyOne Pro and Ecomedics|LCI will be assessed with 2 different devices : EasyOne Pro and Ecomedics
16127785|NCT01951820|Drug|Pliaglis|Apply 0.2mg of compounded topical anesthetic (Pliaglis) to gums for 2.5 minutes before giving patient injection of local anesthetic.
16127786|NCT01951820|Drug|Benzocaine|Apply 0.2mg of topical anesthetic (benzocaine) to gums for 2.5 minutes before giving patient injection of local anesthetic.
16127787|NCT01951820|Drug|Articaine|Injection of 0.4mg of local anesthetic in gum tissue where topical anesthetic was placed
16127788|NCT01951807|Behavioral|Psychotherapy|
16127789|NCT01951781|Other|blood sample|"blood sample in newborn preterms suspected of nosocomial infection (neoCD64 arm)
~When late-onset sepsis is suspected, blood samples are obtained from peripheral veins for a complete blood count, measurement of CRP and PCT concentration and one bacterial culture acording to the current recommendation of the CDC. CD64 concentration measurement require 0.2 ml aditionnal blood."
16127790|NCT01951768|Drug|Garamycin Sponge (Gentamicin-Collagen sponge)|Gentamicin Collagen Sponge: 5 × 5 cm in size containing Type I bovine collagen and 50 mg of gentamicin sulfate (equivalent to 32.5 mg of gentamicin base)
16127791|NCT01951768|Drug|Systemic Antibiotic|"Antibiotics options per protocol:
~Levofloxacin PO 750 mg q.24h or 500 mg q.12h Levofloxacin IV 750 mg q.24h or 500 mg q.12h Amoxicillin/clavulanate PO 500/125 mg q.12h. or q.8h Amoxicillin/clavulanate IV 1000/200 mg q.12h or q.8h Clindamycin PO 300 mg or 450 mg q.6h Clindamycin IV 600 mg q.8h or q.6h Linezolid PO 600 mg q.12h Linezolid IV 600 mg q.12h Metronidazole PO 400 mg or 500 mg q.8h or 500 mg q.6h Metronidazole IV 500 mg q.8h or q.6h Aztreonam IV 1 g or 2 g q.12h or q.8h Piperacillin/tazobactam IV 3000/375 mg q.6h or 4000/500 mg q.8h"
16127792|NCT01951742|Biological|ANT-1401|Active
16127793|NCT01951742|Biological|Vehicle|Vehicle
16127794|NCT01951729|Drug|Control|"Starting at 0 minutes, glucose infusion rates will be increased to 1, 2, 3, 4, 6, and 8 mg/kg/min every 40 minutes. The study is finished at 240 minutes.
~Starting at 0 minutes, an intravenous infusion of saline containing 1% human albumin will continue for 240 minutes."
16127795|NCT01951729|Drug|Xenin-25 without atropine|"Starting at 0 minutes, glucose infusion rates will be increased to 1, 2, 3, 4, 6, and 8 mg/kg/min every 40 minutes. The study is finished at 240 minutes.
~Following a priming dose from 0-10 minutes, xenin-25 (in saline containing 1% human albumin) will be administered at a constant dose of 4 pmoles/kg/min until 240 minutes."
16127796|NCT01951729|Drug|GIP without atropine|"Starting at 0 minutes, glucose infusion rates will be increased to 1, 2, 3, 4, 6, and 8 mg/kg/min every 40 minutes. The study is finished at 240 minutes.
~Following a priming dose from 0-10 minutes, GIP (in saline containing 1% human albumin) will be administered at a dose of 4 pmoles/kg/min until 240 minutes."
16127797|NCT01951729|Drug|Placebo with atropine|"Starting at 0 minutes, glucose infusion rates will be increased to 1, 2, 3, 4, 6, and 8 mg/kg/min every 40 minutes. The study is finished at 240 minutes.
~Following a priming dose from -30 to -28 minutes, atropine will be administered at a constant dose of 0.3 mg/m2/hour until 240 minutes."
16127798|NCT01951729|Drug|Xenin-25 with atropine|"Starting at 0 minutes, glucose infusion rates will be increased to 1, 2, 3, 4, 6, and 8 mg/kg/min every 40 minutes. The study is finished at 240 minutes.
~Following a priming dose from 0-10 minutes, xenin-25 (in saline containing 1% human albumin) will be administered at a dose of 4 pmoles/kg/min until 240 minutes.
~Following a priming dose from -30 to -28 minutes, atropine will be administered at a constant dose of 0.3 mg/m2/hour until 240 minutes."
16127870|NCT01951391|Other|Benzalkonium Chloride Soap|Commercially available soap containing benzalkonium chloride will be used to wash the subject's forearms
16127799|NCT01951729|Drug|GIP with atropine|"Starting at 0 minutes, glucose infusion rates will be increased to 1, 2, 3, 4, 6, and 8 mg/kg/min every 40 minutes. The study is finished at 240 minutes.
~Following a priming dose from 0-10 minutes, GIP (iin saline containing 1% human albumin) will be administered at a dose of 4 pmoles/kg/min until 240 minutes.
~Following a priming dose from -30 to -28 minutes, atropine will be administered at a constant dose of 0.3 mg/m2/hour until 240 minutes."
16127800|NCT01951729|Drug|GIP plus Xenin-25 without atropine|"Starting at 0 minutes, glucose infusion rates will be increased to 1, 2, 3, 4, 6, and 8 mg/kg/min every 40 minutes. The study is finished at 240 minutes.
~Following a priming dose from 0-10 minutes, GIP and xenin-25 will each be administered at a dose of 4 pmoles/kg/min until 240 minutes."
16127801|NCT01951729|Drug|GIP plus Xenin-25 with atropine|"Starting at 0 minutes, glucose infusion rates will be increased to 1, 2, 3, 4, 6, and 8 mg/kg/min every 40 minutes. The study is finished at 240 minutes.
~Following a priming dose from 0-10 minutes, GIP and xenin-25 will each be administered at a dose of 4 pmoles/kg/min until 240 minutes.
~Following a priming dose from -30 to -28 minutes, atropine will be administered at a constant dose of 0.3 mg/m2/hour until 240 minutes."
16127802|NCT01951716|Drug|Graded Glucose Infusion with Placebo|"Starting at 0 minutes, glucose infusion rates will be increased to 1, 2, 3, 4, 6, and 8 mg/kg/min every 40 minutes.
~Starting at 0 minutes, a primed-continuous intravenous infusion of saline containing 1% human albumin will continue for 240 minutes.
~The study is finished at 240 minutes."
16127803|NCT01951716|Drug|Graded Glucose Infusion with GIP Alone|"Starting at 0 minutes, glucose infusion rates will be increased to 1, 2, 3, 4, 6, and 8 mg/kg/min every 40 minutes.
~Starting at 0 minutes, a primed-continuous intravenous infusion of GIP in saline containing 1% human albumin will continue for 240 minutes.
~The study is finished at 240 minutes."
16127804|NCT01951716|Drug|Graded Glucose Infusion with xenin-25 alone|"Starting at 0 minutes, glucose infusion rates will be increased to 1, 2, 3, 4, 6, and 8 mg/kg/min every 40 minutes.
~Starting at 0 minutes, a primed-continuous intravenous infusion of xenin-25 in saline containing 1% human albumin will continue for 240 minutes.
~The study is finished at 240 minutes."
16127805|NCT01951716|Drug|Graded Glucose Infusion with GIP plus xenin-25|"Starting at 0 minutes, glucose infusion rates will be increased to 1, 2, 3, 4, 6, and 8 mg/kg/min every 40 minutes.
~Starting at 0 minutes, a primed-continuous intravenous infusion of GIP plus xenin-25 in saline containing 1% human albumin will continue for 240 minutes.
~The study is finished at 240 minutes."
16127806|NCT01951716|Drug|Meal Tolerance Test with Placebo|"At 0 minutes, a liquid mixed meal (Boost Plus) plus acetaminophen will be ingested.
~Starting at 0 minutes, a primed-continuous intravenous infusion of saline containing 1% human albumin will continue for 300 minutes.
~The study is finished at 300 minutes."
16127807|NCT01951716|Drug|Meal Tolerance Test with xenin-25|"At 0 minutes, a liquid mixed meal (Boost Plus) plus acetaminophen will be ingested.
~Starting at 0 minutes, a primed-continuous intravenous infusion of xenin-25 in saline containing 1% human albumin will continue for 300 minutes.
~The study is finished at 300 minutes."
16127808|NCT01951703|Device|senofilcon A|Control, senfilcon A
16127809|NCT01951703|Device|senofilcon A|Test, senofilcon A
16127810|NCT01951690|Drug|defactinib (VS-6063)|
16127811|NCT01951677|Drug|HBsAg|Standard hepatitis B vaccine antigen
16127812|NCT01951677|Biological|PreS HBsAg|preS hepatitis B surface antigen
16127813|NCT01951677|Biological|Advax-1(TM)|Adjuvant formulated with vaccine antigen
16127814|NCT01951677|Biological|Advax-2(TM)|Adjuvant formulated with vaccine antigen
16127815|NCT01951677|Biological|Advax-3(TM)|Adjuvant formulated with vaccine antigen
16127816|NCT01951677|Biological|Alum|Adjuvant formulated with vaccine antigen
16127817|NCT01951664|Other|Baseline Study Measures|Participants will undergo baseline objective and self-report study measures including: 1) ROM in the jaw, neck, and shoulders; 2) posture assessment; 3) pain, and 4) psychological distress. The study measures will take 30-45 minutes to administer.
16127818|NCT01951664|Behavioral|Yoga Evaluation|The evaluation includes an assessment of nine traditional Yoga components: energy, symptoms, emotions, posture, breathing patterns, gait, muscle/tissue quality, joint flexibility, and muscle strength. Emphasis will be placed on the assessment of jaw/neck/shoulder MSI requiring Yoga practice modification of those poses that are unsafe or not feasible for a patient to perform. Information from the evaluation will be used to establish the tailored Yoga program
16127819|NCT01951664|Behavioral|Yoga Program|The Yoga program has 5 components: 1) Awareness Practice to enhance self-awareness, 2)Poses - 16 core poses will be modified for each patient's specific needs, 3)Breath Work - breath awareness and proper breathing for maximum benefit, 4)Relaxation - alternating between methods of relaxation, 5)Mediation - awareness and practice of inner silence
16127820|NCT01951664|Behavioral|Yoga Practice Plan|To enhance fidelity, a standardized Yoga intervention was chosen that includes postures, meditation, relaxation, and breath work. To ensure safety, the practice plan for each patient will be reviewed prior to initiation. All MSI limitations will be discussed, and appropriate adaptive techniques will be formulated. Qualitative techniques will be used to describe and categorize the types of impairment and modifications. By developing a catalog of impairments and suitable modifications, a safe and uniform Yoga program can be further tested and widely disseminated.
16127821|NCT01951664|Other|Study Assessments|Data collection methods used to assess efficacy include physical measurement/examination, jaw range of motion (device) - scales to measure opening, cervical range of motion(Device), Shoulder Range of Motion - Goniometer, Posture - Wall Zone Grid, self-reported surveys for physical symptoms, pain, psychological symptoms, anxiety, depression and quality of life
16127822|NCT01951651|Drug|Exenatide|Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months.
16127871|NCT01951391|Other|Triclocarban Soap|Commercially available soap containing triclocarban will be used to wash the subject's forearms
16128003|NCT01950416|Drug|Ticagrelor 180mg loading dose and 90mg bid maintenance dose|
16127823|NCT01951651|Drug|Glipizide|Type 2 diabetic subjects will be randomized to receive either Exenatide 10 micrograms twice daily injected subcutaneously or glipizide 5 mg twice daily orally for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma lipids, and glycosylated hemoglobin (HbA1c) as well as measurement of liver and myocardial fat content and left ventricular function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, adipocytokines, HbA1c, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months.
16127824|NCT01951638|Drug|Vericiguat (BAY1021189) (1.25 mg)|1.25 mg BAY1021189 tablets
16127825|NCT01951638|Drug|Vericiguat (BAY1021189) (5 mg)|5 mg BAY1021189 tablets
16127826|NCT01951638|Drug|Placebo|
16127827|NCT01951625|Drug|Vericiguat (BAY1021189) (1.25 mg)|1.25 mg BAY1021189 tablets
16127828|NCT01951625|Drug|Vericiguat (BAY1021189) (5 mg)|5 mg BAY1021189 tablets
16127829|NCT01951625|Drug|Placebo|
16127830|NCT01951612|Behavioral|Executive Function Training Program|Participants will take part in ten 2-hour sessions over 5 weeks.
16127831|NCT01951612|Behavioral|Psychoeducational Training Program|Participants will take part in ten 2-hour sessions over 5 weeks.
16127832|NCT01951599|Drug|AZD9291|Volunteers will receive a single 20-mg dose of AZD9291 as a capsule on day 1, in Part A, Period 1, in the fasted state. (Treatment A).
16127833|NCT01951599|Drug|AZD9291|Volunteers will receive a single 20-mg dose of AZD9291 as a solution on day 1, in Part A, Period 2, in the fasted state. (Treatment B).
16127834|NCT01951599|Drug|AZD9291|Volunteers will receive a single 20-mg dose of AZD9291 as a tablet on day 1, in Part A, Period 3, in the fasted state. (Treatment C).
16127835|NCT01951599|Drug|AZD9291|Volunteers will receive a single 20-mg dose of AZD9291 as a capsule or tablet on day 1, in Part B, Period 1, in the fasted state.
16127836|NCT01951599|Drug|AZD9291|Volunteers will receive a single 20-mg dose of AZD9291 as a capsule or tablet on day 1, in Part B, Period 2, in the fed state.
16127842|NCT01951573|Device|Delefilcon A multifocal contact lenses|Silicone hydrogel multifocal contact lenses for daily wear, daily disposable use
16127843|NCT01951573|Device|Lotrafilcon B multifocal contact lenses|Silicone hydrogel multifocal contact lenses with a labeled indication for daily wear and extended wear use of up to 6 days with monthly replacement
16127844|NCT01951560|Drug|Valproic Acid|By infusion over 1 hour
16127845|NCT01951560|Drug|Isotonic saline solution|By infusion over 1 hour
16127846|NCT01951547|Procedure|Nonsurgical periodontal therapy|Periodontal intervention All patients were instructed in oral hygiene methods using a soft bristled toothbrush, a compact-tuft toothbrush, interdental brushes and dental floss utilizing the modified Bass technique. Full mouth debridement, which consisted of scaling and root planing, was done in a single visit for all subjects using an ultrasonic scaler and gracey curettes. Additionally, all patients were given a 0.12% Chlorhexidine mouthrinse (Hexipro®). They were instructed to rinse three times a day using 15ml each time for a period of 14 days commencing immediately after completion of full mouth debridement. Thereafter at each recall visit, all participants were re-motivated and professional prophylaxis was performed.
16127847|NCT01951547|Procedure|Oral hygiene instructions|All patients were instructed in oral hygiene methods using a soft bristled toothbrush, a compact-tuft toothbrush, interdental brushes and dental floss utilizing the modified Bass technique.
16127848|NCT01951534|Behavioral|Breast Reconstruction Decisional Aid (BRDA)|
16127849|NCT01951534|Behavioral|Usual Care|
16127850|NCT01951521|Radiation|Boost|External Beam radiation delivered using intensity modulation radiation therapy (IMRT) planning, consisting of 15 Gy (in 5 sequential fractions).
16127851|NCT01951508|Drug|Methylphenidate|60mg per os, single dose
16127852|NCT01951508|Drug|Modafinil|600mg per os, single dose
16127853|NCT01951508|Drug|MDMA|125mg per os, single dose
16127854|NCT01951508|Drug|Placebo|per os
16127855|NCT01951482|Drug|Pemetrexed/cisplatin|receive Pemetrexed/cisplatin every 21 days
16127856|NCT01951482|Drug|Bevacizumab and Pemetrexed/cisplatin|receive Bevacizumab 7.5mg/kg and Pemetrexed/cisplatin every 21 days
16127857|NCT01951469|Drug|Gefitinib and Pemetrexed/cisplatin|Gefitinib 250mg is Taken Orally on day 4-28,combined Pemetrexed/cisplatin chemotherapy on day 1-3, every 28 days
16127858|NCT01951469|Drug|Gefitinib mono-therapy|Gefitinib 250mg is Taken Orally everyday
16127859|NCT01951456|Behavioral|Resistance training|
16127860|NCT01951456|Behavioral|Health and Wellness|
16127861|NCT01951443|Dietary Supplement|Ginseng|400mg of encapsulated Rg3-KRG
16127862|NCT01951443|Dietary Supplement|Wheat Bran|400mg of encapsulated wheat bran
16127863|NCT01951430|Drug|Antibiotic and antifungal drugs|
16127864|NCT01951417|Drug|Adapalene/BPO Gel|Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
16127865|NCT01951417|Other|Moisturizer SPF 30|Moisturizer SPF 30 (once daily)
16127866|NCT01951417|Other|Foam Wash|Foam Wash (twice daily)
16127867|NCT01951404|Drug|Allopurinol|
16127868|NCT01951404|Drug|Placebo (for allopurinol)|
16127869|NCT01951391|Other|Control Hand Soap|Commercially available soap will be used to wash the subject's forearms
16128000|NCT01950468|Drug|DaTscan|A single intravenous dose of 3 to 5 mCi
16127872|NCT01951378|Device|Hudson RCI® nebulizer|After the first hour of treatment, patients in the standard arm will receive a repeat assessment, including all of the measurements collected at baseline as well as reported side effects. Those patients who score PAS 0-2 will then be discharged home, after an optional observation period, as per the pathway. Those who score PAS > 2 will receive a second treatment. At the end of the second treatment patients will again be re-assessed, and repeat measurements obtained. At that time, depending on the patient's PAS score, he/she will be dispositioned to home, the floor, the pulmonary high acuity unit (PHAU), or the pediatric intensive care unit (PICU).
16127873|NCT01951378|Device|NebuTech® HDN® nebulizer|All treatments in the NebuTech® arm will be given at a standard dilution of 5 ml (diluted with normal saline to a total volume of 5 ml as per the manufacturer's recommendation). Patients in this arm will receive up to four treatments with parameters measured after each treatment, similar to the control arm. Patients who complete four treatments will then be dispositioned based on PAS score, similar to the control arm. Subjects may have started treatment prior to consent and may receives unit dose (2.5 mg) Albuterol/Proventil treatments will be given with a standard nebulizer up to 3 times as needed and may change over to study randomized device once consented to eith arm.
16127874|NCT01951378|Drug|Albuterol|Subjects may have started treatment prior to consent and may receives unit dose (2.5 mg) Albuterol/Proventil treatments will be given with a standard nebulizer up to 3 times as needed and may change over to study randomized device once consented to eith arm.
16127875|NCT01951352|Other|Soap|
16127876|NCT01951339|Drug|Sitagliptin|100 mg sitagliptin
16127877|NCT01951339|Drug|Glimepiride|"Active Comparator
~2mg glimepiride"
16127878|NCT01951339|Drug|Placebo|2 mg placebo once daily
16127879|NCT01951339|Drug|Placebo|100 mg placebo once daily for three months
16127880|NCT01951326|Drug|RHB-104|95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine
16127881|NCT01951326|Drug|Placebo|5 placebo capsules administered orally BID
16127882|NCT01951313|Other|Egg consumption|Subjects will participate in 3 testing days (randomized, crossover design). Each day, the subject will consume a carefully portioned mix-vegetable salad without eggs (C, control); 75g (about 1½ eggs) scrambled whole egg (LE, low egg), and 150g (about 3 eggs) scrambled whole egg (HE, high egg). Prior to each testing day, subjects will consume a low-carotenoid diet for 7 days to reduce blood carotenoid concentration. In the testing day, blood collected every 60 minutes for 10 hours will be processed to analyze carotenoid and vitamin E concentrations. At the 5-h time point, subjects will be fed a low fat (< 2g) and low carotenoid (< 2000µg) meal as the 2nd meal.
16127883|NCT01951300|Other|Gallium-68 citrate|Single intravenous bolus injection of 200 MBq of Gallium-68 citrate radiopharmaceutical
16127884|NCT01951287|Other|Acute beverage (water) consumption|Acute beverage consumption includes water.
16127885|NCT01951287|Other|Acute beverage (Black Coffee) consumption|Acute beverage consumption includes black coffee.
16127886|NCT01951287|Other|Acute beverage (Orange Juice) consumption|Acute beverage consumption includes Orange Juice..
16127887|NCT01951287|Other|Acute beverage (Whole Milk) consumption|Acute beverage consumption includes whole milk
16127888|NCT01951287|Other|Acute beverage (2% Milk) consumption|Acute beverage consumption includes 2% milk
16127889|NCT01951287|Other|Acute beverage (Skim Milk) consumption|Acute beverage consumption includes skim milk
16127890|NCT01951274|Drug|VPD-737|NK1 Receptor Antagonist
16127891|NCT01951274|Drug|Placebo|
16127892|NCT01951261|Procedure|Telemonitoring and telephone control|Early assisted discharge from hospital due to an exacerbation of chronic obstructive pulmonary disease, with telemonitoring of vitals signs (oxygen saturation, heart rate, respiratory rate, blood pressure, temperature and electrocardiogram)and telephone control dairy (morning, evening)by the pulmonologist.
16127893|NCT01951248|Device|CPAP - continuous airway pressure|3 months of treatment with CPAP treatment
16127894|NCT01951235|Drug|Imeglimin|
16127895|NCT01951235|Drug|Placebo|
16127896|NCT01951222|Drug|V0162|
16127897|NCT01951222|Other|Placebo|
16127898|NCT01951209|Drug|Rifaximin|550mg orally twice daily for 12 weeks
16127899|NCT01951209|Drug|Placebo|Matched placebo
16127900|NCT01951183|Drug|Placebo|RO681135 placebo subcutaneously daily
16127901|NCT01951183|Drug|RO6811135|Subcutaneously daily
16127902|NCT01951170|Drug|Tocilizumab|162 milligrams (mg) tocilizumab was administered subcutaneously once weekly for 24 weeks
16127903|NCT01951157|Drug|Docetaxel|Powder for solution for infusion
16127904|NCT01951157|Drug|Gemcitabine|Powder for solution for infusion
16127905|NCT01951157|Drug|Lurbinectedin (PM01183)|Powder for concentrate for solution for infusion
16127906|NCT01951144|Drug|PF-06372865 or Placebo|PF-06372865 will be administered as an extemporaneously prepared solution for all doses unless the tablet formulation need to be evaluated. Correspondingly, placebo doses will be administered as solution or tablet.
16127907|NCT01951144|Drug|PF-06372865 or Placebo|PF-06372865 will be administered as an extemporaneously prepared solution for all doses unless the tablet formulation need to be evaluated. Correspondingly, placebo doses will be administered as solution or tablet.
16127908|NCT01951144|Drug|PF-06372865 or Placebo|PF-06372865 will be administered as an extemporaneously prepared solution for all doses unless the tablet formulation need to be evaluated. Correspondingly, placebo doses will be administered as solution or tablet.
16127909|NCT01951144|Drug|PF-06372865 or Placebo or Lorazepam|Lorazepam 2 mg dose, PF-06372865 Dose 1, PF-06372865 Dose 2, PF-06372865 Dose 1 and Dose 2 in combination with lorazepam, placebo administered as tablet formulation
16127910|NCT01951118|Drug|Donepezil|Donepezil 5mg will be given for 4 weeks and if tolerated, the dose will be increased to 10 mg per day. The dose range of 5 to 10 mg of donepezil per day will be continued for the study duration, and this is the recommended dose for donepezil in the treatment of mild to moderate Alzheimer's disease. For patients who do not tolerate donepezil or have a history of intolerance to donepezil or cannot take donepezil for other reasons, treatment with other cholinesterase inhibitors (galantamine or rivastigmine) is permitted at any stage of the protocol. Data will be analyzed in two ways: for donepezil alone, and for any cholinesterase inhibitor (donepezil or rivastigmine or galantamine) as the intervention.
16127911|NCT01951105|Drug|Naproxen|Take one 250mg naproxen tablet three times a day for 12 weeks.
16128001|NCT01950455|Drug|NAV5001|A single intravenous dose of 8.0 ± 1.0 mCi
16127912|NCT01951105|Drug|Carbidopa/Levodopa|"12.5mg/50mg Carbidopa/Levodopa, administered orally as capsules, will be titrated up to TID over one week and then continued at that level for 4 weeks. If at the end of this initial 4 week period the participant has responded, the subject will be maintained on that dose for the duration of the treatment period (12 weeks total). If there has not been a response, the dose will be increased to 25mg/100mg Carbidopa/Levodopa TID for the following 4 weeks at which time the pain status will be re-evaluated. If a response has occurred, that dose will be maintained in a blinded manner for the following 4 weeks of treatment; if not, further dose-titration will occur to 50mg/200mg Carbidopa/Levodopa TID for the final 4 weeks. If a subject experiences an AE at higher doses, then the subject will be given the next lower dose that s/he was able to tolerate and then be maintained on that dose for the remainder of the 12 week dosing period."
16127913|NCT01951105|Drug|Placebo|Take two placebo capsules three times a day for 12 weeks.
16127914|NCT01951092|Other|Text messaging|
16127915|NCT01951079|Drug|Intra-amniotic injection of DIGOXIN|
16127916|NCT01951066|Drug|Dexamethasone Implant|Patients will receive a single injection of a dexmethasone implant
16127917|NCT01951066|Drug|Anti-VEGF injection|Patients will receive PRN injections of an anti-VEGF agent
16127918|NCT01951053|Drug|JNJ-40411813|Participants will receive nanosuspension of JNJ-40411813 500 mg orally once daily on Day 3 in appropriate treatment periods.
16127919|NCT01951053|Drug|Placebo|Participants will receive placebo orally once daily on Days 1 to 2 or Days 1 to 3 in appropriate treatment periods.
16127920|NCT01951053|Drug|Citalopram|Participants will receive citalopram 20 mg tablet orally once daily on Day 3 in appropriate treatment periods.
16127921|NCT01951027|Drug|GX-G3 12.5 μg/kg or Placebo|Single SC injection
16127922|NCT01951027|Drug|GX-G3 25 μg/kg or Placebo|Single SC injection
16127923|NCT01951027|Drug|GX-G3 50 μg/kg or Placebo|Single SC injection
16127924|NCT01951027|Drug|GX-G3 100 μg/kg or Placebo|Single SC injection
16127925|NCT01951014|Other|Social Media Education|Health messages provided via a private Facebook group and cellular text messages will be provided across gestation.
16127926|NCT01951001|Drug|Prasugrel|For fixed-dose group, patients will receive prasugrel 10 or 5 mg/d for 1 month Irrespective of platelet function test.
16127927|NCT01950988|Device|Manual toothbrush reference|
16127928|NCT01950988|Procedure|Measure of the dental plaque|
16127929|NCT01950988|Device|Manual toothbrush Broscyl®|
16127930|NCT01950975|Biological|Peripheral blood samples in EDTA tubes|
16127931|NCT01950975|Procedure|Skin biopsies|
16127932|NCT01950962|Other|Sampling of blood|
16127933|NCT01950949|Other|300 ml Hydroxyethyl Starch 130/0.4 and Sodium Chloride Injection infusing in 15 minutes if PPV under VT 8 ml/kg was larger than 13% in the initial investigation|
16127934|NCT01950936|Other|Discontinuation of Antibiotcs|Discontinuation of Antibiotcs against lower respiratory tract infections
16127935|NCT01950923|Drug|sildenafil citrate|Given PO
16127936|NCT01950923|Other|placebo|Given PO
16127937|NCT01950923|Procedure|therapeutic conventional surgery|Undergo standard robotic partial nephrectomy
16127938|NCT01950884|Drug|Ezetimibe|Ezetimibe tablets
16127939|NCT01950884|Behavioral|Lifestyle|lifestyle
16127940|NCT01950871|Device|Prostate HistoScanning|In a single visit, subjects will first be imaged with TRUS for the purpose of generating data for prostate HS analysis. The results of HS analysis will be used later in the procedure. Subjects will then undergo two consecutive biopsy procedures. First, using TRUS, a systematic 10- to 12-core biopsy procedure will be performed. In turn, prostate HS data taken at the beginning of the procedure will be used to determine suspicious areas (displayed as red on an imaging monitor) and used to guide the biopsy procedure. Areas that are identified as suspicious (zero to a maximum of 3 areas) will then be sampled with two biopsy cores. Depending on the number of suspicious areas identified by prostate HS, the number of cores will be zero to a maximum of 6 cores.
16127941|NCT01950858|Biological|Weight reduction|
16127942|NCT01950845|Device|Closed loop automated System (LIR®: learning intravenous resuscitator)|Connection of the system to the patient under supervision of the anesthesiologist team during all the anesthesia procedure, respective of the applicability criteria for the fluid responsiveness detection.
16127943|NCT01950845|Device|manual current practice by anesthesiologist team|The anesthesiologist team will manage the fluid administration during all the anesthesia procedure.
16127944|NCT01950832|Other|Investigating clinically normal patients with optic coherence tomography|
16127945|NCT01950819|Biological|Induction therapy|All subjects received induction therapy with basiliximab or rabbit anti-thymocyte globulin, in the peritransplant period.
16127946|NCT01950819|Drug|Corticosteroids|All subjects received maintenance therapy with corticosteroids throughout the 24 month study period. A minimum dose of 5 mg prednisone, or equivalent, per day was maintained.
16127947|NCT01950819|Drug|EVR+rCNI|Everolimus with reduced calcineurin inhibitor- everolimus (target trough level of 3-8 ng/mL) in combination with reduced exposure to CNI (cyclosporine or tacrolimus)
16127948|NCT01950819|Drug|MPA+sCNI|Mycophenolate (mycophenolic acid sodium or mycophenolate mofetil) in combination with standard exposure to calcineurin inhibitor (cyclosporine or tacrolimus).
16127949|NCT01950806|Other|Pecan-containing diet|
16127950|NCT01950806|Other|Nut-free diet|
16127951|NCT01950793|Drug|triamcinolone acetonide|"used ultrasound-guided inject 1c.c triamcinolone acetonide 10mg/mL (Shincort®, YSP, Taiwan)into the sheath of the flexor tendons, penetrated to the A1 pulley.
~One injection only Steroid"
16127952|NCT01950793|Drug|Hyaluronic Acid|"used ultrasound-guided inject 1c.c Hyaluronic acid (Artz®, Seikagaku, Japan)into the sheath of the flexor tendons, penetrated to the A1 pulley.
~One injection only"
16127953|NCT01950780|Drug|Ruxolitinib|A fixed dose of ruxolitinib (20mg) will be self-administered orally twice daily for 12 to 24 weeks. Dosing may be decreased or held if needed due to adverse effects.
16127954|NCT01950754|Behavioral|standing with both feet|
16127955|NCT01950754|Behavioral|descent of the platform|
16127956|NCT01950754|Behavioral|standing on the platform, feet together and always with simultaneous performance of a task of mental count|
16127957|NCT01950741|Drug|aflibercept|Aflibercept is injected intravitreally though the pars plana using 30G needle-attached syringe.
16128002|NCT01950442|Device|Balloon dilation|
16127958|NCT01950728|Device|Interferential current|Interferential current will be applied during 30 minutes to volunteer's forearm at a strong but comfortable intensity. Carrier frequency will be set at 4 kilohertz (kHz) and modulated frequency will be set at 100 Hz.
16127959|NCT01950728|Device|Aussie Current|Aussie current will be applied during 30 minutes to volunteer's forearm at a strong but comfortable intensity. Carrier frequency will be set at 4 kHz and modulated frequency will be set at 100 Hz.
16127960|NCT01950728|Device|TENS|TENS will be applied during 30 minutes to volunteer's forearm at a strong but comfortable intensity. Pulse duration will be set at 125 microseconds and frequency will be set at 100 Hz.
16127961|NCT01950715|Device|sacral nerve stimulation|Sacral nerve stimulation
16127962|NCT01950702|Procedure|Laryngoscope assisted lightwand intubation|"After standard monitoring(EKG, pulse oximetry, NIBP), participants were induced with remifentanil and propofol continuous infusion, using targe-controlled infusion device with prexoygenation with 100% oxygen.
~Manual in-line stabilization was applied with velcro during intubation to maintain neutral head position.
~The Macintosh laryngoscope (female: 3rd blade, male: 4th blade) was inserted into the oral cavity to provide direct view of the epiglottis and then the tip of the lightwand was placed below the epiglottis."
16127963|NCT01950702|Procedure|Lightwand intubation|"After standard monitoring(EKG, pulse oximetry, NIBP), participants were induced with remifentanil and propofol continuous infusion, using targe-controlled infusion device with prexoygenation with 100% oxygen.
~Manual in-line stabilization was applied with velcro during intubation to maintain neutral head position.
~After 2min from administration of rocuronium, the clinician holds the wand similar to a pencil, stands directly behind the patient's head, inserts the device into the side of the mouth and sweeps the tip to the midline. After confirmation of precise location via clear light source on anterior neck, endotracheal tube was inserted and withdrawn lightwand."
16127966|NCT01950676|Device|Smart phone application|The smart phone application (Diabetes Pal), will guide patients on self-titration of insulin. Patients will be required to key in the CBG readings into the application. Up-titration of insulin dose will be carried out once every 3 days and the recommended insulin dose will be based on the mean of 3 CBG readings and a pre-specified titration algorithm. The process of using the insulin self-titration application will continue until the patient has reached the target pre-breakfast CBG.
16127967|NCT01950663|Device|RETeval|RETeval is a new handheld device intended to detect vision threatening diabetic retinopathy by measuring the response of the retina to a flash of light.
16127968|NCT01950650|Behavioral|No treatment given|Survey conducted through computer-assisted telephone interviewing.
16127969|NCT01950650|Behavioral|survey|Survey conducted via the Internet.
16127970|NCT01950637|Behavioral|No treatment given|Completion of 90-item online questionnaire.
16127971|NCT01950637|Behavioral|survey|Completion of 58-item online questionnarie.
16127972|NCT01950611|Drug|Bortezomib|Combination of arsenic trioxide with bortezomib in the treatment of relapsed acute promyelocytic leukemia
16127973|NCT01950598|Procedure|Boston KPro type I - fresh graft|Boston KPro mounted on fresh corneal carrier graft for implantation
16127974|NCT01950598|Procedure|Boston KPro type I surgery - frozen graft|Boston KPro mounted on frozen corneal carrier graft for implantation
16127975|NCT01950585|Drug|Hydroxyurea|
16127976|NCT01950559|Other|Oral food challenge|Oral food challenge to determine allergy to soy
16127977|NCT01950546|Drug|nanosilver fluoride|The product will be applied in the volunteers in the morning, before the first class, in relative isolation, made with cotton rolls and Vaseline to protect the soft tissue. It will apply 30mg of the product with microbrush, previously standardized in a pilot study on cervical vestibular surfaces of incisors and canines healthy, on a total of 8 teeth, 4 upper and 4 lower. After a period of 7 days,the cervical dental biofilms will be collect, third on the buccal surfaces of incisors and / or canines upper and lower, with the aid of sterile spatulas.
16127978|NCT01950533|Procedure|Oral food challenge|Confirmation of allergy to egg, milk and/or peanut through an oral food challenge or documentation of a positive oral food challenge.
16127979|NCT01950520|Drug|Propranolol|Propanolol 160mg, oral, by mouth (Cohort 1 only)
16127980|NCT01950520|Drug|Pindolol|Pindolol 20mg, oral, by mouth (Cohort 1 only)
16127981|NCT01950520|Drug|Dantrolene|Dantrolene 100mg, oral, by mouth (Cohort 1 only)
16127982|NCT01950520|Drug|Magnesium Sulfate|Magnesium Sulfate, infusion, 50 mg/kg bolus followed by maintenance infusion at 2g/h (Cohort 1 only)
16127983|NCT01950520|Drug|Caffeine|Caffeine 200mg, oral, by mouth (Cohort 2 only)
16127984|NCT01950520|Drug|Qysmia|Qysmia (topiramate 92mg CR, phentermine 15mg PO), oral, by mouth (Cohort 2 only)
16127985|NCT01950520|Drug|Topiramate|Topiramate 200mg, oral, by mouth (Cohort 2 only)
16127986|NCT01950520|Behavioral|Phentermine|Phentermine 37.5mg, oral, by mouth (Cohort 2 only)
16127987|NCT01950520|Drug|Naltrexone|Naltrexone 100mg, oral, by mouth (Cohort 2 only)
16127988|NCT01950520|Drug|Mirabegron 50mg|Mirabegron 50mg, oral, by mouth (Cohort 3 only)
16127989|NCT01950520|Drug|Mirabegron 200mg|Mirabegron 200mg, oral, by mouth (Cohort 3 only)
16127990|NCT01950520|Drug|Placebo Cohort 1|Placebo, oral, by mouth (Cohort 1 only)
16127991|NCT01950520|Drug|Placebo Cohort 2|Placebo, oral, by mouth (Cohort 2 only)
16127992|NCT01950520|Drug|Placebo for Mirabegron|Placebo for Mirabegron, oral, by mouth (Cohort 3 only)
16127993|NCT01950507|Drug|Budesonide|Entocort EC 3 mg given orally three times daily for at least 14 days
16127994|NCT01950507|Drug|Fluconazole|400 mg orally once daily for CrCl greater than or equal to 50 ml/min
16127995|NCT01950507|Drug|Voriconazole|Subjects in Cohort 1 who are not established on voriconazole will receive a loading dose of 400 mg orally every 12 hours for 2 doses, then 200 mg orally every 12 hours
16127996|NCT01950507|Drug|Micafungin|Micafungin will be dosed as 100 mg as an intravenous infusion once daily at 09:00 for inpatients, and 200 mg to 300 mg as an intravenous infusion administered two to three times weekly for outpatients
16127997|NCT01950494|Other|fiteBac Hand Sanitizer|Skin gel created for health care workers that is currently on the market. This sanitizer has an additive layer to protect the skin that is also thought to helpo hand dermatitis.
16127998|NCT01950481|Drug|LDK378|Oral LDK378 750 mg once
16127999|NCT01950468|Drug|NAV5001|A single intravenous dose of 8.0 ± 1.0 mCi
16128004|NCT01950416|Drug|Clopidogrel 600mg loading dose and 150mg maintenance dose|
16128005|NCT01950403|Drug|linaclotide acetate|Given PO
16128006|NCT01950403|Other|placebo|Given PO
16128007|NCT01950403|Other|pharmacological study|Correlative studies
16128008|NCT01950403|Other|laboratory biomarker analysis|Correlative studies
16128009|NCT01950390|Biological|Bevacizumab|Given IV
16128010|NCT01950390|Biological|Ipilimumab|Given IV
16128011|NCT01950364|Drug|brentuximab vedotin|Brentuximab vedotin will be administered every 3 weeks at a dose of 1.8 mg/kg.
16128012|NCT01950364|Drug|Brentuximab vedotin and rifampicin|Brentuximab vedotin will be administered every 3 weeks at a dose of 1.8 mg/kg beginning on Cycle 1, Day 1; daily rifampicin (600 mg PO) will be administered during Cycles 0 through 3 only, beginning on Cycle 0, Day 1 (7 days before the Cycle 1, Day 1 dose of brentuximab vedotin) and continuing through Cycle 3, Day 21.
16128013|NCT01950351|Other|Laboratory Biomarker Analysis|Correlative studies
16128014|NCT01950351|Radiation|Proton Beam Radiation Therapy|Undergo proton beam radiation therapy
16128015|NCT01950351|Other|Quality-of-Life Assessment|Ancillary studies
16128016|NCT01950338|Other|Dry needling|Once the most painful spot is located within a palpable spastic taut band, the overlying skin is cleaned with alcohol. The needle will be inserted, penetrating the skin about 15-20mm, until the first local twitch response is obtained. Once the first local twitch response is obtained, the needle will be moved up and down (4 to 5 mm. vertical motions with no rotation) in the muscle at approximately 1Hz for 25-30 seconds.
16128017|NCT01950325|Biological|VRC-HIVMAB060-00-AB|VRC01 Human Monoclonal Antibody
16128018|NCT01950312|Drug|gevokizumab|
16128019|NCT01950299|Drug|Anakinra 100 mg|Anakinra 100 mg starting immediately and then every 24 hours
16128020|NCT01950299|Drug|Anakinra 100 mg|Anakinra 100 mg starting 12 hours after first dose and then every 24 hours (so that Anakinra is given every 12 hours)
16128021|NCT01950299|Drug|Placebo|Placebo 0.67 ml injections twice daily
16128022|NCT01950273|Drug|BI 695500|BI695500, once a week for 4 weeks (4 administrations in total)
16128023|NCT01950273|Drug|MabThera|MabThera, once a week for 4 weeks (4 administrations in total)
16128024|NCT01950260|Drug|Levothyroxine|Early initiation of levothyroxine after radioactive iodine (to start at 4 weeks).
16128025|NCT01950260|Other|Placebo|Placebo to start at 4 weeks after RAI
16128026|NCT01950247|Drug|Injectafer|2 doses at 15 mg/kg for a maximum single dose of 750 mg given 7 days apart for a total of up to 1500 mg.
16128027|NCT01950247|Drug|SOC|
16128028|NCT01950234|Drug|ACTH|Acthar gel
16128029|NCT01950234|Drug|Placebo|Placebo
16128030|NCT01950221|Dietary Supplement|POMx|"POMx is a 1,000 milligram capsule of natural pomegranate polyphenol extract."
16128031|NCT01950221|Other|Placebo|
16128032|NCT01950195|Procedure|Stereotactic Radiosurgery (SRS)|
16128033|NCT01950195|Biological|Ipilimumab|
16128034|NCT01950182|Drug|Endocrine therapy combined with trastuzumab|Tamoxifen or aromatase inhibitors (Anastrozole, Letrozole, or Exemestane) combined with trastuzumab
16128035|NCT01950182|Drug|Chemotherapy combined with trastuzumab|Capecitabine , Vinorelbine, or Gemcitabine combined with trastuzumab
16128036|NCT01950169|Drug|Risedronate|The bisphosphonate group (B) receive 35 mg risedronate (Optinate® Septimum) once weekly for 12 months and calcium (1000 mg) and vitamin D3 (800 IU) (Calcichew-D3®) daily for 12 months.
16128037|NCT01950169|Other|Nutritional supplement|The bisphosphonate and nutritional supplemented group (BN) receive 35 mg risedronate once weekly for 12 months plus nutritional supplement (Fresubin® protein energy drink) during the first six months following hip fracture and also calcium (1000 mg) and vitamin D3 (800 IU) daily for 12 months.
16128038|NCT01950169|Dietary Supplement|Calcium and vitamin D3|The patients in the control group (C) receive orally administered calcium 1000 mg and 800 IU vitamin D3 (Calcichew-D3®) daily for 12 months.
16128039|NCT01950156|Biological|HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvant|Open Label, Non-Randomized, Safety/Efficacy study: patients will be vaccinated subcutaneously once a week with HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides with adjuvant.
16128040|NCT01950143|Dietary Supplement|Standard broccoli soup|Volunteers will be required to consume one portion of broccoli soup per week as part of their normal diet for one year.
16128041|NCT01950143|Dietary Supplement|Beneforte broccoli soup|Volunteers will be required to consume one portion per week of a soup containing glucoraphanin-enriched broccoli (Beneforte®) as part of their normal diet for one year.
16128042|NCT01950143|Dietary Supplement|Beneforte extra broccoli soup|Volunteers will be in which they will be required to consume one portion per week of a soup containing an other variety of glucoraphanin-enriched broccoli (Beneforte extra) as part of their normal diet for one year.
16128043|NCT01950130|Procedure|Preoperative IABC|IABP-Insertion upon inclusion into the trial and admission to the ICU
16128044|NCT01950117|Procedure|Endoscopic mucosal resection|Nonpedunculated neoplastic colorectal polyps from 10 mm to 25 mm in diameter were resected after submucosal injection of saline solution before removal.
16128045|NCT01950117|Procedure|Conventional polypectomy|Nonpedunculated neoplastic colorectal polyps from 10 mm to 25 mm in diameter were resected using conventional polypectomy. Submucosal injection of saline solution before removal was not performed.
16128046|NCT01950104|Other|Day 3 embryo biopsy|Embryo biopsy is applied at day 3 of the embryo development.
16128047|NCT01950104|Other|Blastocyst biopsy|Embryo biopsy is applied at the blastocyst stage of the embryo development
16128048|NCT01950091|Behavioral|FitBack on-line intervention|On-line Fitback intervention: Self care for on-going pain; behaviors to lessen the chance of reoccurrence
16128049|NCT01950091|Other|Alternative Website Control|Intervention is a Menu of links to 4 popular Websites offering back pain education
16128050|NCT01950065|Device|iovera|
16128051|NCT01950052|Dietary Supplement|Diet group 800 Kcal diet|Pre-operative liver shrinking diet of 800 kcal is administered for 4 weeks
16128052|NCT01950039|Drug|Betaine|Betaine or placebo administered orally in divided doses over 12 weeks
16128053|NCT01950039|Drug|Placebo|Placebo administered orally in divided doses over 3 months
16128240|NCT01948713|Other|Strengthening of hip muscles.|Kegel exercises and strengthening of hip muscles as Gluteus Maximus and Medius and adductor muscles
16128054|NCT01950026|Procedure|cryotherapy application|"Height, weight and BMI verification
~subjects in supine position after 20 minutes of resting
~cryotherapy application by cold thermal bag (thermoGel brand) size P
~15-20 cm above the ASIS
~temperature verified before and after cryotherapy application with an infrared thermometer CA 380 CASON brand, Brazil"
16128055|NCT01950013|Behavioral|Auditory training program|Previous experiments performed under laboratory settings using a novel word-based auditory-training regimen have demonstrated substantial improvements in open-set recognition of words and sentences in noise. The current proposed study will investigate the effectiveness of the training regimen when used in a patient's home setting with their own hearing aids.
16128056|NCT01950013|Behavioral|Sham Comparator: Active Control|This is a sham intervention in which the patient listens to audio books following the same regimen as the patients receiving the auditory training.
16128057|NCT01950000|Drug|Fentanyl|
16128058|NCT01950000|Other|Placebo|
16128059|NCT01949987|Other|two hours|
16128060|NCT01949987|Other|one hour|
16128061|NCT01949974|Drug|Standard Palliative Chemotherapy|Standard Palliative Chemotherapy, depending on type cancer.
16128062|NCT01949974|Other|Integral Attention Program (PAI)|The PAI is a plan of care and treatment adapted in accordance with the evolution and needs of patients. This plan includes an initial comprehensive assessment of patients and their families during the first visit, including specialized psychological and social support when needed, voluntary art therapy and/or mindfulness. There will be outpatient monitoring, 24h phone assistance, home visits, support should hospitalization be required, and unscheduled visits by a palliative care team.
16128063|NCT01949961|Other|Ultrasound|SonoVue solution 10 ml (2 vials / 80 µl microbubbles) is given as an infusion of 0,3 ml/min for ~30 minutes, using a Bracco infusion pump.
16128064|NCT01949961|Other|Sham ultrasound|Mounting the ultrasound headframe but connecting this to a non-operative channel
16128065|NCT01949948|Drug|Tenecteplase|0.4 mg/kg single bolus intravenously
16128066|NCT01949948|Drug|Alteplase|0.9 mg/kg as 10% bolus + 90% infusion/60 minutes intravenously
16128067|NCT01949935|Drug|Mupirocin|
16128068|NCT01949922|Procedure|Injection of autologous muscle fibers into the anal sphincter.|
16128069|NCT01949922|Procedure|Pelvic floor muscle training|Pelvic floor muscle training 3 months to optimize pelvic floor muscle function. Autologous muscle stem cell injection will only be offered to patients that still have problems after completion of pelvic floor muscle training.
16128070|NCT01949922|Behavioral|Dietary intervention|Dietary intervention 3 months to optimize defecatory function. Autologous muscle stem cell injection will only be offered to patients that still have problems after completion of pelvic floor muscle training and dietary intervention.
16128071|NCT01949922|Drug|Analgesia|Patients will be offered analgesia as needed during and after surgery. Specific products will depend on allergy and preferences of doctors involved and patient's requirements.
16128072|NCT01949909|Biological|CH-Alum50|intramuscular administration to Swiss volunteers of Alhydrogel and P27A antigen (50 microg)
16128073|NCT01949909|Biological|CH-GLA2.5/50|intramuscular administration to Swiss volunteers of GLA-SE (2.5microg) together with the P27A antigen (50 microg)
16128074|NCT01949909|Biological|TZ Ver|intramuscular administration of Rabies vaccine Verorub TM to in Phase IIb only to 8 Tanzanian volunteers in three injections
16128075|NCT01949909|Biological|TZ Alum 50|intramuscular administration to Tanzanian volunteers of Alhydrogel and P27A antigen (50 microg)
16128076|NCT01949909|Biological|TZ GLA 2.5/10|intramuscular administration to Tanzanian volunteers of GLA-SE (2.5 microg ) together with the P27A antigen (10 microg)
16128077|NCT01949909|Biological|TZ GLA5/50|intramuscular administration to Tanzanian volunteers of GLA-SE (5 microg) together with the P27A antigen (50 microg)
16128078|NCT01949909|Biological|TZ GLA2.5/50|intramuscular administration to Tanzanian volunteers of GLA-SE (2.5microg) together with the P27A antigen (50 microg)
16128079|NCT01949896|Other|NPO|Infants in this group will be made NPO for a period of time surrounding the packed red blood cell transfusion.
16128080|NCT01949896|Other|Control group: continue feedings|Feedings will be continued in this group.
16128081|NCT01949883|Drug|CPI-0610|
16128082|NCT01949870|Drug|Cisplatin|day1 and day8 at each cycle
16128083|NCT01949870|Drug|Gemcitabine|day1 and day8 at each cycle
16128084|NCT01949870|Drug|Selumetinib|25mg/day, 50mg/day and 75mg/day
16128085|NCT01949857|Biological|Attenuated HAV Vaccine, H2 Strain|6.50 lgCCID50/Vial in babies aged 18-35 months\6.50 lgCCID50/Vial in children aged 3-15 years \6.50 lgCCID50/Vial in adults aged 16 up to 65 years old, only one dose (1Vial/dose).
16128086|NCT01949857|Biological|Attenuated HAV Vaccine, L-A-1 Strain|6.50 lgCCID50/Vial in babies aged 18-35 months\6.50 lgCCID50/Vial in children aged 3-15 years \6.50 lgCCID50/Vial in adults aged 16 up to 65 years old, only one dose (1Vial/dose).
16128087|NCT01949857|Biological|Inactivated HAV Vaccine, Lu8 Strain|320EU/Vial in babies aged 18-35 months\320EU/Vial in children aged 3-15 years \640EU/Vial in adults aged 16 up to 65 years old\boost at month 6\two-dose
16128088|NCT01949857|Biological|Inactivated HAV Vaccine, TZ84 Strain|250U/Vial in babies aged 18-35 months\250U/Vial in children aged 3-15 years \500U/Vial in adults aged 16 up to 65 years old\boost at month 6\two-dose.
16128089|NCT01949844|Drug|regadenoson|Lexiscan® is being used off-label. The FDA Issued IND # is 119898. For the cardiac MRI, Lexiscan® will be used at the same dosage and administration as prescribed in the package insert - 5 mL (0.4 mg regadenoson) as packaged and supplied by the manufacturer, Astellas Pharma U.S., in single-use pre-filled syringes administered by rapid intravenous injection, followed immediately by saline flush.
16128090|NCT01949844|Drug|Optimark®|For the cardiac MR, the contrast agent, Optimark® is administered as a bolus peripheral intravenous injection at a dose of 0.2 mL/kg (0.1 mmol/kg) and at a rate of 1 to 2 mL/sec delivered by manual injection.
16128091|NCT01949844|Device|Myocardial perfusion MRI|
16128092|NCT01949831|Other|Assessment of functional ability in combination with follow-up at home|
16128093|NCT01949818|Drug|Yangzhengxiaoji capsule combined with CHOP regimen|Yangzhengxiaoji capsule combined with CHOP regimen(Yangzhengxiaoji capsule,Cyclophosphamide,Vincristine,Doxorubicin,Prednisone)Yangzhengxiaoji capsule ,1.56g,Tid,p.o,d7-21, Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5.
16128241|NCT01948700|Behavioral|Motivational Interviewing|
16128094|NCT01949818|Drug|CHOP regimen|CHOP regimen(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5
16128095|NCT01949805|Drug|Peg-P-IFN-alpha-2b (AOP2014)|Pegylated interferon alpha 2b given Q2W as SC injection
16128096|NCT01949805|Drug|Hydroxyurea|Hydroyurea capsules taken daily po
16128097|NCT01949792|Drug|eptacog alfa (activated)|Subject will receive a single injection (i.v.) of 270 microg/kg rFVIIa (NovoSeven®)
16128098|NCT01949792|Drug|eptacog alfa (activated)|Subject will receive 3 injections (i.v.) of 90 microg/kg rFVIIa (NovoSeven®) over a 6 hour period (each injection will be separated by 3 hours)
16128099|NCT01949779|Device|TransForm™ Occlusion Balloon Catheter|TransForm™ Occlusion Balloon Catheter
16128100|NCT01949766|Drug|Glycerol phenylbutyrate|
16128101|NCT01949753|Behavioral|Exposure therapy with pharmacological facilitation|Exposure with response prevention and pharmacological facilitation
16128102|NCT01949753|Behavioral|Exposure therapy|Exposure with response prevention without pharmacological facilitation
16128103|NCT01949740|Other|questionnaire administration|Ancillary studies
16128104|NCT01949740|Procedure|quality-of-life assessment|Ancillary studies
16128105|NCT01949727|Other|AIM 2: Pulmonary Rehabilitation|Patients exercise 2 hours per session which includes aerobic exercise (20-40 minutes per session) as well as strength training. All exercise is carefully tracked by trained Respiratory or Physical Therapists. Patients also receive education from a multi-disciplinary team aimed at patient self-management.
16128106|NCT01949714|Procedure|Removal of adrenal tumor|
16128107|NCT01949701|Biological|HLA-A*0201restricted URLC10 peptides with adjuvant|Open Label, Non-Randomized, Safety/Efficacy study: patients will be vaccinated subcutaneously once a week with HLA-A*0201restricted URLC10 peptides with adjuvant.
16128108|NCT01949688|Biological|HLA-A*2402 or A*0201 restricted peptides|"Open Label, Non-Randomized, Safety/Efficacy study:
~HLA-A*2402-positive patients will be vaccinated subcutaneously once a week with HLA-A*2402 restricted peptides for VEGF-R1 and VEGF-R2 with adjuvant.
~HLA-A*0201-positive patients will be vaccinated subcutaneously once a week with HLA-A*0201 restricted peptides for VEGF-R1 and VEGF-R2 with adjuvant."
16128109|NCT01949675|Biological|Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell|1.5 mL, Oral administration
16128110|NCT01949675|Biological|Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell|1.5 mL, Oral administration
16128111|NCT01949675|Biological|Shanchol™: Oral Cholera Vaccine Killed Bivalent (O1 and O139) Whole Cell|1.5 mL, Oral administration
16128112|NCT01949662|Drug|Lorazepam|3 mg by vein one time only.
16128113|NCT01949662|Drug|Placebo|Placebo consisting of preservative free 0.9% normal saline given one time by vein.
16128114|NCT01949662|Drug|Haloperidol decanoate|8 mg/day by vein.
16128115|NCT01949662|Behavioral|Questionnaires|Questionnaire completion at baseline, and every day while participant is in the palliative care unit. These questions will take about 20 minutes to complete.
16128116|NCT01949649|Behavioral|Peer-Led Group Intervention|
16128117|NCT01949649|Behavioral|Internet-Based Intervention|
16128118|NCT01949649|Behavioral|Clinician-Led Group Intervention|
16128119|NCT01949649|Behavioral|Education Video|
16128120|NCT01949636|Other|Functional Magnetic Resonance Imaging|
16128121|NCT01949623|Other|Anterior Chamber (AC) tap|Aqueous Samples will be collected for measurement of biomarkers
16128122|NCT01949610|Drug|14C-JNJ26489112|Participants will receive single dose of oral suspension of 1000 mg (10 mL) of 14C-JNJ26489112 on Day 1.
16128123|NCT01949597|Procedure|laparoscopic surgery for deep endometriosis|
16128124|NCT01949584|Device|nasal continuous positive airway pressure less than or equal to 6 cm H2O|Low level continuous positive airway pressure delivered during sleep.
16128125|NCT01949571|Drug|Mirtazapine (REMERON, Schering-Plough-Organon)|During the first and second phase of the study,the mirtazapine group received 30 mg of mirtazapine daily. During the third phase, the mirtazapine group received 15 mg of mirtazapine.
16128126|NCT01949558|Behavioral|Dietary Intervention|
16128127|NCT01949545|Drug|Carfilzomib|Carfilzomib was administered by IV injection over 30 minutes
16128128|NCT01949532|Drug|Carfilzomib|Carfilzomib was administered by IV injection.
16128129|NCT01949519|Drug|Lycopene and Docetaxel|During administration of standard of care Docetaxel at 75 mg/m2 on day 15 and every 21 days, study patients will also receive Lycopene at the dose specified per the dose cohort they are enrolled. There are three dose cohort levels as follows: Dose level 1 = 30 mg PO every day; Dose level 2 = 90 mg PO every day; Dose level 3 = 150 mg PO every day.Treatment will continue until disease progression or toxicity or patient withdrawal.
16128130|NCT01949506|Radiation|SBRT|Stereotactic Body Radiation Therapy
16128131|NCT01949493|Device|mechanical traction|Twelve treatments with mechanical traction using the Phystrac traction apparatus. The Phystrac provides traction to the wrist using weights between 1 and 18 kg. The weights provide a pulling force in line with the forearm. After 8 seconds the weight is lifted, and there is a rest period of 4 seconds. This cycle will be repeated 10 times. Another two sets of 10 traction movements will be applied with the wrist positioned in 30 degrees supination and 30 degrees pronation. In total, 30 traction movements will be applied during each treatment.
16128132|NCT01949493|Other|Care as usual|Usual care provided by the neurologist (e.g. corticosteroid injection, wrist splint, carpal tunnel release surgery).
16128133|NCT01949480|Procedure|Thoracotomy|
16128134|NCT01949480|Procedure|Video-Assisted Thoracoscopic Surgery (VATS)|
16128135|NCT01949467|Drug|iron fumarate|All patients will receive a tablet of 66mg of iron, in the form of iron fumarate (Fumafer®) with 50 ml water.
16128136|NCT01949454|Drug|Fluorometholone 0.1% ophthalmic solution|
16128137|NCT01949454|Other|Artificial tears (Placebo)|Artificial tears (Placebo)
16128138|NCT01949441|Biological|ToleroMune HDM|Intradermal injection 1 x 4 administrations 4 weeks apart
16128139|NCT01949441|Biological|Placebo|Intradermal injection 1 x 4 administrations 4 weeks apart
16128185|NCT01949116|Drug|LDMTX|"LDMTX 5 mg: one 5-mg capsule by mouth once weekly
~LDMTX 10 mg: two 5-mg capsules by mouth once weekly
~LDMTX 15 mg: three 5-mg capsules by mouth once weekly"
16128242|NCT01948700|Other|Education|
16128308|NCT01948050|Device|non-invasive transcranial direct current stimulation (tDCS)|
16128140|NCT01949402|Other|Computed Tomography|"The CT scan will be performed on a 16 slice GE Discovery 670 SPECT CT scanner. A slice thickness of 0.625mm will be used. Images are acquired during an inspiratory breath hold of up to 20 seconds to minimise movement artefact. The patient will be lying supine and the scan will be a non-contrast study. Using a low dose CT chest protocol (1.7 mSv) will minimise the exposure to ionising radiation of study participants.
~Participants in the haemodialysis arm of the study will have a CT done before and after haemodialysis. Participants in all other arms will have a single CT scan done during their study visit."
16128141|NCT01949402|Other|Thoracic ultrasound|The ultrasound will be performed by a single operator. The patient's position will ideally be with the patient sitting up at 45°. Ultrasound images and clips will be recorded at 10 points over each hemithorax - the 2nd, 4th and 6th intercostal spaces (ICS) in the mid-clavicular line; the 2nd, 4th and 6th ICS in the mid-axillary line; and the 2nd, 5th, 7th and 9th ICS posteriorly. Ultrasound estimation of the height of the right internal jugular vein will be undertaken. Central venous pressure will be calculated by adding 5cm. Inferior vena cava diameter will also be measured at end-inspiration and expiration. The time taken to perform each ultrasound will be recorded. Control, COPD and ILD groups will be scanned on a single occasion. Haemodialysis group will have 4 scans.
16128142|NCT01949402|Other|Spirometry|All participants in the study will undergo basic spirometry as specified in the study assessments. This is considered a low-risk intervention and no harm is expected as a consequence of participation in the study.
16128143|NCT01949402|Other|Blood tests|All participants in the study will undergo blood tests as specified in the study assessments. This is considered a low-risk intervention and no harm is expected as a consequence of participation in the study.
16128144|NCT01949389|Behavioral|Internet-based Cognitive Behavioral Therapy for Insomnia|This is an internet-based Cognitive Behavioral treatment for insomnia. It is accessed via a computer with an internet connection and consists of 7 modules, homework, and a daily sleep log. The intervention is self administered.
16128145|NCT01949363|Drug|Cefixime|Cefixime is an FDA approved oral semi-synthetic cephalosporin antibiotic. The standard dose (400mg), high dose (800mg and 1200mg), and multiple 800mg and 1200mg doses given over a 24-hour period using a dose-frequency escalation method. Cohort A receives 400 mg orally once, Cohort B receives 800 mg orally once; Cohort C receives 1200 mg orally once; Cohort D receives 800 mg orally 3 times (every 8 hrs)
16128146|NCT01949350|Dietary Supplement|Carbohydrate|Participants will be asked to drink an isotonic carbohydrate loaded drink (preload)night before the test and also two hours prior to the CPX test.
16128147|NCT01949350|Dietary Supplement|Carbohydrate protein|Participants will be asked to drink an isotonic carbohydrate drink (Highfive energy source 4:1)the night prior to the test and also two hours prior to the CPX test.
16128148|NCT01949350|Dietary Supplement|Starved|Participants will be asked to starve as per normal clinical requirements for surgery. They are allowed to drink water upto 2 hours prior to the CPX test
16128149|NCT01949337|Drug|enzalutamide|Enzalutamide 160 mg daily, orally
16128150|NCT01949337|Drug|abiraterone|abiraterone 1000 mg daily, orally
16128151|NCT01949337|Drug|prednisone|prednisone 5 mg twice daily, orally
16128152|NCT01949324|Biological|Ciliary neurotrophic factor (CNTF)|Ciliary neurotrophic factor released from NT-501 encapsulated cell implant
16128153|NCT01949324|Procedure|Sham procedure|Sham surgery for Sham arm
16128154|NCT01949324|Device|NT-501 Implant|NT-501 encapsulated cell implant
16128155|NCT01949324|Procedure|NT-501 Implant procedure|Surgery to implant device for NT-501 encapsulated cell implant releasing human ciliary neurotrophic factor arm
16128156|NCT01949311|Drug|Dupilumab|
16128157|NCT01949298|Procedure|dental implant placement|
16128158|NCT01949285|Device|Transcutaneous Electrical Spinal Cord Stimulation|A prototype device that non-invasively delivers electrical stimulation to the spinal cord will be used to assess and rehabilitate spared spinal cord function.
16128159|NCT01949272|Device|esophageal pressure mesurement|"EXPRESS study ventilatory setting the optimization of PEEP with esophageal pressure mesurement"
16128160|NCT01949233|Drug|Irbesartan 150-300mg capsules daily for 6 months|
16128161|NCT01949233|Drug|Doxycycline 100-200mg capsules daily for 6 months|
16128162|NCT01949233|Drug|Doxycycline placebo capsules daily for 6 months|
16128163|NCT01949233|Drug|Irbesartan placebo capsules daily for 6 months|
16128164|NCT01949207|Procedure|EVLA|Endovenous laser ablation of great saphenous vein
16128165|NCT01949207|Procedure|phlebectomies|removal of incompetent veins
16128166|NCT01949207|Procedure|TRansluminal Occlusion of Perforators (TRLOP)|TRansluminal Occlusion of Perforators (TRLOP) closure of incompetent perforators.
16128167|NCT01949194|Drug|Regorafenib|"The dose of regorafenib given will be 160 mg once a day (od) oral (po), using a 21 days on / 7 days off treatment schedule. This equates to four (4) tablets once a day for three (3) weeks. The patient should take the dose at the same time each day, with a full glass of water, and following a light meal. A light mealconsists of less than 30% fat and around 300-550 calories."
16128168|NCT01949181|Procedure|Lung surgery|
16128169|NCT01949168|Drug|Victrelis® (boceprevir) 800mg by mouth, TID (200 mg tablets)|
16128170|NCT01949168|Drug|Peg-Intron® (peginterferon-α-2b), 1.5ug/kg sc injection|
16128171|NCT01949168|Drug|Rebetol® (ribavirin), 1000/1200mg by mouth daily|
16128172|NCT01949155|Drug|OTO-201|Single, intratympanic injection
16128173|NCT01949155|Drug|Sham|Simulated single, intratympanic injection
16128174|NCT01949142|Drug|OTO-201|Single, intratympanic injection
16128175|NCT01949142|Drug|Sham|Simulated single, intratympanic injection
16128176|NCT01949129|Drug|VP16|60 mg/kg BW,1 day
16128177|NCT01949129|Radiation|TBI|2 x 2Gy/day , 3 days (total 12Gy)
16128178|NCT01949129|Drug|Thiotepa|2x5 mg/kg BW, 1 day
16128179|NCT01949129|Drug|Treosulfan|14g/m² BS, 3 days
16128180|NCT01949129|Drug|Fludarabine|30 mg/m² BS, 5 days
16128181|NCT01949129|Drug|Busulfan|iV, dosage according therapeutic drug monitoring, 4 days
16128182|NCT01949129|Drug|ATG Thymoglobulin|MD: ATG Thymo: 2,5mg/kg BW/d 3 days.
16128183|NCT01949129|Drug|Cyclophosphamide|50mg/kg BW/d 2 days with Mesna
16128184|NCT01949129|Drug|Grafalon|MD: 15mg/kg BW/d 3 days MMD: 10mg/kg BW/d 3 days
16128239|NCT01948713|Other|Strengthening of pelvic floor muscles.|Kegel exercises kinesiotherapy
16128186|NCT01949116|Drug|Placebo|"Placebo 5 mg: one 5-mg capsule by mouth once weekly
~Placebo 10 mg: two 5-mg capsules by mouth once weekly
~Placebo 15 mg: three 5-mg capsules by mouth once weekly"
16128187|NCT01949116|Dietary Supplement|Folic acid|1-mg tablet of folic acid by mouth once a day
16128188|NCT01949103|Drug|TD-1607|
16128189|NCT01949103|Drug|Placebo|
16128190|NCT01949090|Biological|Investigational H7N1 vaccine GSK2789869A|Two doses of GSK2789869A H7N1 vaccine administered intramuscularly to the deltoid region at Day 0 and Day 21.
16128191|NCT01949090|Biological|Placebo|Two doses of placebo administered intramuscularly to the deltoid region at Day 0 and Day 21.
16128192|NCT01949064|Device|Grindcare|
16128193|NCT01949064|Device|Michigan-type occlusal splint|
16128194|NCT01949051|Drug|Levocabastine|Intranasal aqueous 50 mcg microsuspension of levocabastine supplied in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension
16128195|NCT01949051|Drug|Placebo|Intranasal aqueous 0 mcg microsuspension supplied in an amber glass bottle fitted with a white top actuated plastic metering atomising spray pump filled with a uniform white suspension
16128196|NCT01949038|Drug|Oral alprazolam|
16128197|NCT01949038|Drug|Sublingual alprazolam|
16128198|NCT01949038|Drug|Oral placebo|
16128199|NCT01949038|Drug|Sublingual placebo|
16128200|NCT01949025|Other|ALARM intervention|The training of nursing and medical staff about the observation, detection, assessment and communication of deteriorating and critically ill patients and the introduction of a standardized observation and communication protocol on medical and surgical wards.
16128201|NCT01949012|Other|Capnography|Capnography waveform and capnometry readings
16128202|NCT01948999|Procedure|ECT|Electroconvulsive Therapy inclusive anesthesia and concomitant muscular paralysis
16128203|NCT01948999|Procedure|SHAM ECT|Anesthesia and concomitant muscular paralysis
16128204|NCT01948999|Drug|Anesthesia|Temporary induced state of analgesia
16128205|NCT01948986|Drug|Ertugliflozin|Single oral administration of 3 X 5 mg tablets.
16128206|NCT01948973|Device|Subsensory|The stimulation is here set to 90% of the sensory threshold
16128207|NCT01948973|Device|OFF|The stimulation is here turned OFF
16128208|NCT01948973|Drug|Suprasensory|The stimulation is here set suprasensory
16128209|NCT01948960|Drug|everolimus dose escalation|patients with an AUC below mean will have dose escalation of everolimus based on their AUC
16128210|NCT01948947|Device|Transcranial Magnetic Stimulation|Active-repetitive transcranial magnetic stimulation (rTMS) at the dorsal lateral prefrontal cortex.
16128211|NCT01948947|Device|Sham Transcranial Magnetic Stimulation|Sham rTMS will consist of the same parameters as active, however, the subject will be shielded from the magnetic field of the coil.
16128212|NCT01948934|Procedure|Amniotic membrane in big wounds|The wound will be washed with saline and debrided if necessary. Control microbiological cultures will be taken and applied amniotic membrane fragments sufficient to cover the wound, putting in contact the basement membrane of the AM with granulation tissue
16128213|NCT01948921|Drug|placebo|
16128214|NCT01948921|Drug|Meperidine|
16128215|NCT01948908|Drug|Intranasal midazolam|Intranasal midazolam, 0.5 mg/kg, maximum dose 10 mg, administered using mucosal atomization device (MAD).
16128216|NCT01948895|Drug|Desvenlafaxine|Patients will be initiated on 50 mg/day of Desvenlafaxine. No dose changes will be allowed for the first four weeks. If there is partial or no response after four weeks, dosage will then be increased to 100mg/day, based on tolerability and the Investigator's judgment.
16128217|NCT01948882|Device|ESS505 (BAY1454033)|
16128218|NCT01948869|Device|Phoenix II (BAY81-2996)|
16128219|NCT01948869|Device|Phoenix I (BAY81-2996)|
16128220|NCT01948856|Drug|J022X ST|"Oral administration - During 6 months and according to the approved summary of product characteristics : 1 sachet per day in the morning on an empty stomach
~First month: 4 consecutive days per week during 3 consecutive weeks
~5 next months: 4 consecutive days per month at monthly intervals"
16128221|NCT01948856|Drug|Placebo|"Oral administration - During 6 months : 1 sachet per day in the morning on an empty stomach
~First month: 4 consecutive days per week during 3 consecutive weeks
~5 next months: 4 consecutive days per month at monthly intervals"
16128222|NCT01948843|Drug|ADI-PEG 20|
16128223|NCT01948830|Drug|Ranibizumab 0.5mg|0.5 mg ranibizumab (intravitreal injections) prefilled syringe)
16128224|NCT01948830|Drug|Ranibizumab 0.5mg|0.5 mg ranibizumab (intravitreal injections) prefilled syringe)
16128225|NCT01948817|Drug|Deferasirox|Deferasirox 20mg/kg taken BID
16128226|NCT01948804|Drug|GnrH Antagonist/letrozole protocol (Cetrotide; serono + Femara; Novartis Pharma AG)|
16128227|NCT01948804|Drug|microdose flare-up protocol (Lucrin; Abbott + Gonal F, Serono)|
16128228|NCT01948804|Drug|Antagonist/clomiphene protocol (Cetrotide; serono + Klomen, Kocak pharma)|
16128229|NCT01948804|Drug|GnRH antagonist protocol (Cetrotide, Serono)|
16128230|NCT01948791|Drug|ENA713|The following strengths of Rivastigmine capsules were provided: Rivastigmine capsule strengths: 1.5mg, 3mg, 4.5mg. The 6mg dose was administered as one 1.5mg capsule and one 4.5mg capsule, and when necessary, the 3mg dose could also be administered as two 1.5mg capsules. Rivastigmine was administered from 3mg/d at baseline. Then dose escalation was made in 3mg/d increments, at a minimun of 4 weeks between dose increases to a maximum dose of 12mg/d or the individual's best tolerated dose.
16128231|NCT01948778|Device|oXiris™ filter|
16128232|NCT01948778|Device|Toraymyxin Filter|
16128233|NCT01948778|Device|Standard of Care|
16128234|NCT01948765|Drug|Xenon and propofol|xenon 30% in oxygen as an adjuvant to propofol target controlled infusion (target of 0.5-1.5µg/ml)
16128235|NCT01948765|Drug|propofol|propofol target controlled infusion (target 1.5-2.5µg/ml)
16128236|NCT01948752|Other|Nutrition information on menus|
16128237|NCT01948739|Device|MAHI EXO-II exoskeleton augmented with BMI system|In this longitudinal study, adult subjects with hemiparesis due to acute or chronic stroke will receive robotic-assisted training through an EEG-based BMI control of robotic exoskeleton to study the changes in upper extremity motor function, cortical plasticity (using the EEG and fMRI). The training will be provided 3x/week for 12 sessions over one-month period.
16128238|NCT01948726|Radiation|Hypofractionation with simultaneous integrated boost|
16128243|NCT01948674|Behavioral|Computerized tasks|The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
16128244|NCT01948661|Dietary Supplement|Mirtoselect® + Meriva®|
16128245|NCT01948661|Dietary Supplement|Placebo|
16128246|NCT01948648|Drug|Colesevelam|Drug is in powder form, each packet contains 3.75g of colesevelam hydrochloride. Participant will mixed it with water and have 1 packet per day during the treatment session.
16128247|NCT01948648|Dietary Supplement|Fish Oil|In softgel form, contains 660mg EPA and 330mg DHA. Participant consume 1 softgel per day during treatment session.
16128248|NCT01948648|Drug|Combination of fish oil and colesevelam|combination of both colesevelam and fish oil. Participant will consume 1 packet and 1 softgel per day during treatment session.
16128249|NCT01948635|Device|tapered PVC-cuffed tracheal tubes|Patients will be intubated with tapered-shape tracheal tubes
16128250|NCT01948635|Device|Standard PVC-cuffed tracheal tube|Patients will be intubated with standard PVC cuffed tracheal tubes
16128251|NCT01948622|Drug|Mulungu|500 mg/single dose/1 hour before dental surgery
16128252|NCT01948622|Drug|Placebo|500 mg/single dose/1 hour before dental surgery
16128253|NCT01948596|Dietary Supplement|Omega-3 polyunsaturated fatty acids|
16128254|NCT01948583|Drug|Hyaluronic Acid|Arm I: new formulation applied for the first week, formulation on the marked applied for the third week (second week - wash out period) Arm II: formulation on the marked applied for the first week, new formulation applied for the third week (second week - wash out period)
16128255|NCT01948557|Behavioral|Infant feeding counselling and support|"Counselling of appropriate feeding practices as recommended in WHO/UNICEF/UNAIDS guidelines on HIV and infant feeding. Subsequent intensive, home-based support of exclusive breastfeeding or safe replacement feeding according to mothers' selection of feeding practice. Counselling contacts with mothers varied over time. 1-2 antenatal contacts. After delivery, home visits by infant feeding counsellors 3-4 times in first 2 weeks then every 2 weeks until 6 months.
~Outcome data collected by separate field based team who were blinded to mothers HIV status and infant feeding practice."
16128256|NCT01948531|Drug|Gynomunal® gel|A fixed quantity of the cosmetic product will be applied on the face (including the submental area) twice a day, in the morning and in the evening (preferentially always at the same hour), with a mild massage according to the instructions received by the investigator during the basal visit (T0).
16128257|NCT01948518|Drug|Oral sildenafil 20 mg|A single dose of sildenafil will be given after recording baseline diffusion capacity and 6 minute walk. Measurements will be repeated one hour after the drug.
16128258|NCT01948505|Drug|Intravenous acetaminophen|
16128259|NCT01948505|Drug|Placebo for IV acetaminophen|
16128260|NCT01948492|Dietary Supplement|Protein intake|On the study day, the diet will be provided as free amino acids, with calories made up by a liquid diet and protein free cookies. Protein intakes will be varied as 0.2, 0.5, 0.7, 0.9, 1.0, 1.2, 1.5, 1.8, 2.0 g/kg/day.
16128261|NCT01948479|Device|Optimised instant offloading insole|
16128262|NCT01948466|Behavioral|Commercials|These commercials will display child actors and try to grab the attention of the 3rd - 5th grade viewers. They will be humorous, fun, and call the viewer to action so the students will feel they should consume fruits and vegetables like the children in the commercials.
16128263|NCT01948453|Dietary Supplement|Garlic|Garlic tablet in adjunct to medical treatment
16128264|NCT01948440|Behavioral|ASI-MV Solutions|The Experimental group will complete the ASI-MV and use the ASI-MV Solutions program for eight 30-minute sessions, followed by monthly booster sessions. The Experimental group will undergo a baseline assessment and one-month post-baseline, two-month post-baseline, and six-month post-intervention.
16128265|NCT01948414|Procedure|electroencephalography|
16128266|NCT01948414|Biological|Blood sampling|
16128267|NCT01948414|Behavioral|Questionnaires regarding eating habits (TFEQ, EDI) and anxiety/depression (HAD)|
16128268|NCT01948401|Drug|LABA|long-acting beta-agonist treatment
16128269|NCT01948401|Drug|corticosteroids|chronic treatment with oral corticosteroids, high dose inhaled corticosteroids
16128270|NCT01948401|Drug|prednisolone|additional 0.5 mg/kg orally for 7 days
16128271|NCT01948388|Drug|corticotrophin 80 units|Comparison of different dosages of the drug. Ten patients will receive 80 units of corticotrophin weekly. Ten patients will receive 80 units bi-weekly of corticotrophin
16128272|NCT01948375|Device|real needle- placebo needle|All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles.
16128273|NCT01948375|Device|placebo needle - real needle|All acupoints were needled through the pad but just pressed against the skin without penetration by pragmatic placebo needle, while through the pad and into the skin 15 mm by real needle. For each intervention, LI4 and RN12 are needled first in a supine position for 15 minutes; BL36 and BL25 are needled secondly in a prone position for another 15 minutes. After withdrawal of the needle, participants were asked to give answers on perception of skin penetration, needle sensation and acupuncture pain. Acupuncture was given every other day, three sessions for one kind of needle, six sessions in total for each subject. There was a two-day interval between the applications of two kinds of needles.
16128274|NCT01948362|Drug|Sulforadex|Active compound
16128275|NCT01948362|Drug|Alpha cyclodextrin|Placebo control
16128276|NCT01948349|Other|Tongue scraping|Two of four groups will use tongue scraping in conjunction with a normal oral hygiene protocol.
16128277|NCT01948349|Other|Bracket design|Two groups will be allocated to have self-ligating (Carriere) brackets. The other two groups will receive standard twin brackets.
16128278|NCT01948336|Drug|Dexmedetomidine|a loading dose of 1 µg kg-1 dexmedetomidine (Precedex Abbott Labs, North Chicago, IL) IV given over 10 minutes, followed by 0.5 µg kg-1 hour-1 IV dexmedetomidine infusion were administered. Dexmedetomidine was prepared as a 1 µg ml-1 solution using D5 0.3% NaCl solution.
16128279|NCT01948336|Drug|Ketamine|ketamine was bolused with 1 mg kg-1(IV) and followed by 1 mg kg-1 hour-1 ketamine IV infusion during the procedure.
16128280|NCT01948336|Drug|Propofol|propofol was bolused 1 mg kg-1 and 50 µg kg-1 min-1 propofol (IV) infusion during the procedure.
16128281|NCT01948323|Behavioral|HEDUAfrica IT package+ standard care|"The HEDUAfrica website aims to target disadvantaged pregnant women representing the core aspect of the intervention. The website is available on a touch screen panel at the two intervention clinics, (Cape Town and Soweto, South Africa). A trained healthcare worker will assist women by means of a touchscreen tablet at the follow up sessions. The website content includes a number of short videos and health messages related to a pregnancy-specific-disease outcomes.
~Participants are also asked to complete 2 questionnaires (24 hour dietary recall assessment and short messaging service technology driven) in conjunction to engaging with the HEDUAfrica website. The intervention is standardized across all participants in the intervention group."
16128282|NCT01948310|Drug|Ranolazine|Comparison of Ranolazine 1000mg twice per day versus placebo twice per day
16128283|NCT01948310|Behavioral|Aerobic Exercise|Aerobic exercise 3 times per week, 45 minutes per session at an intensity of 10-20 beats per minute below the angina threshold (heart rate at which angina symptoms began on the stress test)
16128284|NCT01948310|Drug|Placebo|Comparison of placebo twice per day vs. Ranolazine 1000mg twice per day
16128285|NCT01948297|Drug|Debio1347 (CH5183284)|Debio1347 (CH5183284) tablets for oral administration
16128286|NCT01948284|Procedure|half-maximal pressure|the pressure level of the suction unit (DF 601, Hanlien, Taipei, Taiwan) will be set at the half-maximal (-35 cm Hg).
16128287|NCT01948284|Procedure|maximal pressure|The pressure level of the suction unit (DF 601, Hanlien, Taipei, Taiwan) will be set at the maximal (-70 cm Hg).
16128288|NCT01948284|Device|Suction Unit|
16128289|NCT01948271|Drug|Trichuris Suis Ova|During the treatment phase, study drug will be provided in a liquid form and will be administered every 2 weeks, starting with the Baseline visit, through Week 14.
16128290|NCT01948258|Device|Clearblue Advanced Fertility Monitor|Clearblue Advanced Fertility Monitor used for one menstrual cycle in a home setting
16128291|NCT01948245|Device|TaurolockTMHep100|2-4 ml of the catheter lock solution will be instilled after each infusion of parenteral nutrition/intravenous fluids varying between twice weekly to once daily, depending on the individual patients HPN programme. The instilled solution is kept in the catheter until the next infusion, with a prior flushing with 10 ml of Saline both before the instillation of the catheter lock and before infusion of HPN/fluids.
16128292|NCT01948245|Device|Heparin 100 IE/ml|2-4 ml of the catheter lock solution will be instilled after each infusion of parenteral nutrition/intravenous fluids varying between twice weekly to once daily, depending on the individual patients HPN programme. The instilled solution is kept in the catheter until the next infusion, with a prior flushing with 10 ml of Saline both before the instillation of the catheter lock and before infusion of HPN/fluids.
16128293|NCT01948232|Drug|Perindopril|Angiotensin converting enzyme inhibitor
16128294|NCT01948219|Device|ENTegral Artificial Larynx implant|
16128295|NCT01948193|Biological|Hexaxim™: DTaP-IPV-Hep B-PRP~T combined vaccine|0.5 mL, Intramuscular
16128296|NCT01948180|Biological|baltaleucel-T|Autologous EBV-specific T-cells
16128297|NCT01948167|Behavioral|Interpersonal Psychotherapy- Adolescent Skills Training|A group prevention program that includes a 60-minute pre-group session, 8 weekly 90-minute group sessions, a 60-minute mid-group session, and 3 60-minute booster sessions. IPT-AST focuses on psychoeducation and interpersonal skill-building to decrease interpersonal conflict and increase interpersonal support and competence.
16128298|NCT01948167|Behavioral|Coping with Stress|A group prevention program that consists of 8 acute 90-minute group sessions, 2 parent group sessions, and 3 continuation sessions lasting 60 minutes each. Participants are taught to apply cognitive techniques to their personal thoughts, with the goal of generating effective counterarguments to unrealistic negative beliefs.
16128299|NCT01948141|Drug|nintedanib|Given PO
16128300|NCT01948128|Drug|Vitamin D3|Participants will take 4 capsules of Vitamin D which equals 40,000 IU by mouth daily during the wait time between diagnosis and surgery.
16128301|NCT01948128|Other|Placebo|Participants will take 4 capsules of placebo by mouth daily during the wait time between diagnosis and surgery.
16128302|NCT01948115|Drug|equimolar mixture of oxygen and nitrous oxide or medical air|"We need to include 150 patients for a period of 2 years. Patients will be randomized: 75 patients in each arm: 75 patients in group placebo (medical air), 75 patients in group treatment (equimolar mixture of oxygen and nitrous oxide).
~Patients will be single-blind. The ECV be started at least 3 minutes after the start of administration. The maximum time of administration of the gas will be 15 minutes. Just after ECV, we compare success rate of intervention."
16128303|NCT01948089|Behavioral|Variable Structured Cognitive Exercise|This exercise uses the n-back paradigm in which participants are asked to keep track of one or two series of sequentially presented auditory and/or visual stimuli in order to detect targets that match those presented n-items ago in the sequence. The task begins at 1-back (i.e., watch for targets that match those just presented) and gets harder (e.g., watch for matches with items presented 2 or 3 items ago in the sequence) as performance improves. The stimuli will vary weekly, and include varying auditory letters or words, or varying visual patterns or faces.
16128304|NCT01948089|Behavioral|Constant Structured Cognitive Exercise|This exercise uses the n-back paradigm in which participants are asked to keep track of one or two series of sequentially presented auditory and/or visual stimuli in order to detect targets that match those presented n-items ago in the sequence. The task begins at 1-back (i.e., watch for targets that match those just presented) and gets harder (e.g., watch for matches with items presented 2 or 3 items ago in the sequence) as performance improves. The stimuli will remain constant throughout the 10 week intervention
16128305|NCT01948076|Device|resident with GE vscan|resident with GE vscan
16128306|NCT01948063|Drug|Ubiquinol|Depending on the patient's ability to swallow pills, patients in the experimental group will receive 200mg Ubiquinol in either a pill or a liquid. The liquid form of the study med will be mixed with 50 milliliters of Ensure (a dietary supplement) to ensure blinding. This will be given every 12 hours for 7 days or until hospital discharge.
16128307|NCT01948063|Dietary Supplement|Placebo|Depending on the patient's ability to swallow pills, patients in the control group will receive a placebo pill or a liquid placebo, which is 50 milliliters of Ensure (a dietary supplement). This will be given every 12 hours for 7 days or until hospital discharge.
16128312|NCT01948024|Drug|Asenapine|10 mg BID sublingual tablet
16128313|NCT01948011|Drug|Racecadotril suspension|Racecadotril suspension at 10, 30 and 60mg. Single oral dose.
16128314|NCT01948011|Drug|Racecadotril granules|Racecadotril granules at 60mg. Single oral dose.
16128315|NCT01947998|Drug|Rivaroxaban (Xarelto, Bay59-7939)|"The treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE), and prevention of recurrent DVT and PE in adult patients (15 mg rivaroxaban twice daily [bid] for 3 weeks, then 15 mg or 20 mg once daily [od], tablets).
~The prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (stroke prevention in atrial fibrillation [SPAF]) with one or more risk factors (20 mg rivaroxaban [od], tablets).
~The prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery (recommended dose: 10 mg rivaroxaban [od] tablets for 35 days following hip replacement surgery and 14 days following knee replacement surgery).
~Co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (recommended dose 2.5 mg rivaroxaban tablets [bid])."
16128316|NCT01947998|Drug|Warfarin|For VTE prevention, DVT/PE treatment and SPAF, standard of care is treatment with the most widely used vitamin K antagonist, warfarin.
16128317|NCT01947998|Drug|Antiplatelet drugs|For the secondary prevention of ACS, standard of care is antiplatelet drug(s) such as low-dose acetylsalicylic acid, clopidogrel, dipyridamole, prasugrel, ticlopidine and ticagrelor
16128318|NCT01947985|Drug|Rivaroxoban (Xarelto, Bay59-7939)|"The treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE), and prevention of recurrent DVT and PE in adult patients (15 mg rivaroxaban twice daily [bid] for 3 weeks, then 15 mg or 20 mg once daily [od], tablets).
~The prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (stroke prevention in atrial fibrillation [SPAF]) with one or more risk factors (20 mg rivaroxaban [od], tablets).
~The prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery (recommended dose: 10 mg rivaroxaban [od] tablets for 35 days following hip replacement surgery and 14 days following knee replacement surgery).
~Co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (recommended dose 2.5 mg rivaroxaban tablets [bid])."
16128319|NCT01947985|Drug|Standard of care|For DVT/PE treatment and SPAF, standard of care is treatment with the most widely used vitamin K antagonist, phenprocoumon, and for the secondary prevention of ACS, standard of care is antiplatelet drug(s) such as low-dose acetylsalicylic acid, clopidogrel, dipyridamole, prasugrel, ticlopidine and ticagrelor.
16128320|NCT01947972|Dietary Supplement|Tailored protein fortification|4-4.5g of protein/kg/d
16128323|NCT01947946|Biological|Benralizumab|"Benra 30 mg q.4 Weeks is a fixed 30 mg dose of benralizumab subcutaneously on study week 0 until study week 44 inclusive.
~Benra 30 mg - Placebo q.8 Weeks is a fixed 30 mg dose of benralizumab, every 4 weeks for the first 3 doses and then every 8 weeks thereafter, (placebo injections administrated at the 4 week interim visits to maintain blind). It is subcutaneously administered on study week 0 until study week 44 inclusive."
16128324|NCT01947946|Biological|Placebo|Placebo subcutaneously on study week 0 until study week 44 inclusive.
16128325|NCT01947933|Biological|Mirikizumab- IV|Administered IV
16128326|NCT01947933|Biological|Mirikizumab - SC|Administered SC
16128327|NCT01947933|Biological|Placebo - IV|Administered IV
16128328|NCT01947920|Drug|Tramadol HCl, 50 mg|50-mg overencapsulated tablet for oral administration
16128329|NCT01947920|Drug|Placebo|Size-matching capsules containing an appropriate inactive excipient
16128330|NCT01947907|Drug|ACP-001|Once weekly subcutaneous injection
16128331|NCT01947907|Drug|Human Growth Hormone|Once daily subcutaneous injection of human Growth Hormone
16128332|NCT01947894|Other|Non Interventional Study|Non Interventional Study
16128333|NCT01947855|Drug|Placebo|Placebo tablet matching Empagliflozin low dose
16128334|NCT01947855|Drug|Empagliflozin|Empagliflozin low dose
16128335|NCT01947855|Drug|Placebo|Placebo tablet matching Empagliflozin high dose
16128336|NCT01947855|Drug|Placebo|Placebo tablet matching Empagliflozin low dose
16128337|NCT01947855|Drug|Empagliflozin|Empagliflozin high dose tablet once daily
16128338|NCT01947855|Drug|Placebo|Placebo tablet matching Empagliflozin high dose
16128339|NCT01947842|Device|Smartphone App Dosecast|The Dosecast app is configured to remind the patient to take their medication.
16128340|NCT01947803|Drug|Paliperidone Palmitate|Paliperidone Palmitate is injected with a dose of 150 mg eq. on Day 1 and 100 mg eq. on Day 8 in the deltoid muscle, followed by a monthly flexible dose range of 75 - 150 mg eq. for injection, based on patients' tolerability and/or efficacy. Monthly doses can be administered in either the deltoid or gluteal muscle alternatively. All the antipsychotics should be discontinued prior to the first dose of study drug. Other antipsychotics are prohibited across this study.
16128341|NCT01947790|Drug|pioglitazone group|
16128342|NCT01947790|Drug|Metformin group|
16128343|NCT01947777|Drug|IPI-145|25 mg oral capsule
16128344|NCT01947777|Drug|Rifampin|2x 300 mg oral capsule
16128598|NCT01945840|Other|Gut hormone infusion|
16128345|NCT01947764|Behavioral|HADITHI Intervention|"The HADITHI Intervention consists of a culturally adapted, multi-component clinic-based intervention designed to support families in pediatric HIV disclosure in Kenya.
~In addition to the Usual Care components, the HADITHI Intervention clinics will have the following intervention components:
~Culturally modified curricula materials, including videotaped narratives, to guide counseling and group sessions.
~Dedicated disclosure counselors to initiate and conduct disclosure, with one-on-one counseling for caregivers and children, as well as family-based sessions.
~Post-disclosure peer support groups, facilitated by the disclosure counselors, for children who have gone through disclosure."
16128346|NCT01947751|Procedure|CVC exchange|CVC exchange when related infection is suspected
16128347|NCT01947751|Drug|CVC maintenance|CVC maintenance and adding antibiotic therapy when related infection is suspected, waiting for the cultures to take the decision of changing CVC
16128348|NCT01947738|Drug|VBY-891|Cathepsin S inhibitor
16128349|NCT01947738|Drug|Placebo|
16128350|NCT01947712|Dietary Supplement|dark chocolate with crossover to milk chocolate|40 g/d of dark chocolate for 4 weeks followed by wash-out (1 week) and by 40 g/d of milk chocolate for 4 weeks
16128351|NCT01947712|Dietary Supplement|milk chocolate with crossover to dark chocolate|40 g/d of milk chocolate for 4 weeks followed by wash-out (1 week) and by 40 g/d of dark chocolate for 4 weeks.
16128352|NCT01947699|Drug|Glyburide|
16128353|NCT01947699|Device|Continuous glucose monitor|
16128354|NCT01947686|Device|Robotically guided patellofemoral UKA isolated patellofemoral implants|A robot guided isolated patellofemoral unicompartmental knee arthroplasty procedures to replace only the patellofemoral component of the knee.
16128355|NCT01947673|Other|Mindfulness Meditation|
16128356|NCT01947673|Other|Health Education|
16128357|NCT01947660|Drug|Systemic analgesia + Continuous regional anesthesia|Systemic analgesia + Continuous regional anesthesia, peri neural for the 2 to 4 first days post-operative
16128358|NCT01947660|Drug|Systemic analgesia|Systemic analgesia as usual
16128359|NCT01947647|Behavioral|Transdiagnostic Behavior Therapy|A new transdiagnostic CBT protocol for the depressive/anxiety disorders was developed and revised through two demonstration studies and one focus group. The resulting protocol involves several primary components, including psychoeducation on the symptoms of depression and anxiety (session 1), assessment of motivation and setup of treatment plans (session 2), exposure therapy (sessions 3-15), and relapse prevention (final session). In addition to these primary components, optional modules are included to supplement exposure therapy later in treatment to address secondary symptoms (e.g., anger, sleep, hypervigilance, drinking to cope). The goal of these modules is to allow providers to tailor treatment to specific symptoms that may be present in any single or set of diagnoses that may be reducing the effects from the primary exposure approach. Session will be weekly for 45-60 minutes with homework assignments to be completed between sessions.
16128360|NCT01947647|Behavioral|Behavioral Activation Therapy|To provide an evidence-based comparison for the transdiagnostic CBT condition, a second group of participants will receive manualized BAT. In general, BAT involves teaching patients to monitor their mood and daily activities with the goal of increasing pleasant, reinforcing activities and reducing unpleasant events. In the present study, the BAT condition will be manualized, following an existing protocol in the literature. BAT will be structurally equivalent to the transdiagnostic CBT with the same session length (45-60 minutes), frequency of sessions (weekly), duration of treatment (12-16 sessions), and amount of homework.
16128361|NCT01947634|Other|ResMed Apnea Link plus|Overnight respiratory polygraphy to detect sleep-related breathing disorders is performed in Fabry patients
16128362|NCT01947608|Drug|LDK378|750 mg. orally
16128363|NCT01947595|Behavioral|intensified lifestyle intervention|"physical activity 6 hours per week, 50% guided activity
~recorded by an accelerometer (Aipermotion 440)
~16 sessions per year with a lifestyle advisor
~nutritional advice (target weight: 5% less, if BMI > 25kg/m², less than 30% fat per caloric intake, less than 10% fatty acids per caloric intake, more than 15 g fibre per 1000 kcl)"
16128364|NCT01947595|Behavioral|normal lifestyle intervention|"physical activity 3 hours per week
~recorded by an accelerometer (Aipermotion 440)
~8 sessions per year with a lifestyle advisor
~nutritional advice (target weight: 5% less, if BMI > 25kg/m², less than 30% fat per caloric intake, less than 10% fatty acids per caloric intake, more than 15 g fibre per 1000 kcl)"
16128365|NCT01947595|Behavioral|Single lifestyle advice|"- Single Health care advice and lifestyle advice (30 minutes) at the beginning
~recommend the individual target weight (5% less, if BMI 25> kg/m²)"
16128366|NCT01947582|Device|Ankle foot orthosis|The ankle foot orthoses (AFOs) that will be used are designed to provide assistance with anterior tibial advancement during stance and dorsi flexion assistance during swing. The device(s) are polypropylene and are custom-fabricated.
16128367|NCT01947569|Biological|Biological|
16128368|NCT01947556|Drug|insulin aspart|After hyperglycaemia (18-23 mmol/l) has been reached (by decreasing or interrupting exogenous insulin administration 12-24 hours before the experiment), aspart insulin (in a dose of 1.5 times the amount of insulin needed to reduce blood glucose to 6 mmol/l calculated by the insulin-sensitivity factor) will be administered subcutaneously by Insujet pen or conventional insulin pen, on two separate occasions, or vice versa. The injection will be given by the subject under supervision of the research staff.
16128369|NCT01947530|Procedure|Navigational Bronchoscopy|
16128370|NCT01947530|Procedure|Standard Bronchoscopy|
16128371|NCT01947517|Device|Parasol Punctal Occluder|Patients will be randomized to receive one of these 2 punctal occluders in the management of dry eyes.
16128372|NCT01947517|Device|Superflex Punctal Occluder|Patients will be randomized to receive one of these 2 punctal occluders in the management of dry eyes.
16128373|NCT01947504|Behavioral|education and support intervention|
16128374|NCT01947491|Drug|DFD01 Spray|
16128375|NCT01947491|Drug|Comp01 Lotion|
16128376|NCT01947491|Drug|Vehicle Lotion|
16128377|NCT01947491|Drug|Vehicle Spray|
16128378|NCT01947478|Device|MDT-2113 Drug-Eluting Balloon|Subjects will be randomized (2:1) to the MDT-2113 Drug-Eluting Balloon Arm or to the standard non-coated PTA balloon Arm
16128379|NCT01947478|Device|Standard angioplasty balloon|Subjects will be randomized (2:1) to the MDT-2113 Drug-Eluting Balloon Arm or to the standard non-coated PTA balloon Arm
16128509|NCT01946438|Biological|Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation),|0.5 mL, Intramuscular
16128380|NCT01947465|Biological|Hepatitis A vaccine and tetanus vaccine|Hepatitis A and/or tetanus vaccination will be given to participants in all group on day 0. All monovalent active hepatitis A vaccinations and all vaccines containing tetanus toxoid available in Switzerland may be used in the study
16128381|NCT01947452|Behavioral|Employment|Community organizations will place youth in summer jobs based on youth interests and the availability of positions. Jobs will be part-time in non-profit and government organizations. Youth will be paid the IL minimum wage of $8.25 per hour. The community organizations will provide job mentors to assist youth with barriers to work like transportation or clothing, and to provide supervision at the job site.
16128382|NCT01947452|Behavioral|Social-Emotional Learning|Community organizations will provide 2 hours of social-emotional learning programming for 5 hours a day. The programming is based on cognitive behavioral therapy principles designed to help youth learn to understand and manage their emotions and behavior. It seeks to teach: self awareness (recognizing one's emotions and values as well as one's strengths and limitations), self management (managing emotions and behaviors to achieve one's goals), social awareness (showing understanding and empathy for others), relationship skills (forming positive relationships, working in teams, and dealing effectively with conflict), and responsible decision-making (making ethical, constructive choices about personal and social behavior).
16128383|NCT01947439|Procedure|Percutaneous Coronary Intervention|Percutaneous Transluminal coronary angioplasty and Intervention will be performed in both of randomized groups of biolimus A9 eluting stent and zotarolimus eluting stent
16128384|NCT01947426|Dietary Supplement|DHA Supplementation|mothers consuming 400 mg of DHA/day and their neonates
16128385|NCT01947426|Dietary Supplement|Control (milk without DHA)|mothers consuming placebo product and their neonates
16128386|NCT01947413|Other|intermittent theta burst stimulation|In intermittent theta burst stimulation pattern (iTBS) will intermittently give a 2 s train of TBS every 10s for a total of 20 times (low pulse: 600 pulses in total)
16128387|NCT01947413|Other|continuous theta burst stimulation|In continuous burst stimulation pattern (cTBS) will intermittently give a cTBS treatment consists of a continuous train of TBS for 40 seconds(low pulse: 600 pulses in total).
16128388|NCT01947413|Other|sham theta burst stimulation|In sham burst stimulation pattern (sham TBS) will intermittently give a sham TBS treatment consists of a continuous train of TBS for 40 seconds(almost no pulse: 600 pulses in total).
16128389|NCT01947400|Other|Hospitalists|AIDET Training
16128390|NCT01947374|Procedure|Matrix encapsulated chondrocyte implantation|Each implant contains 6,000,000 autologous chondrocytes.
16128391|NCT01947374|Procedure|Microfracture awl|Is an awl that allow perforation of the subchondral bone.
16128392|NCT01947348|Procedure|treatment with A3 SVF|Treatment interarticular and IV with A3 SVF
16128393|NCT01947335|Device|IVUS-guided PCI|Intravascular ultrasound guided percutaneous coronary intervention
16128394|NCT01947322|Drug|Allogenic NK cells infusion|HLA Haploidentical selected NK cell infusion (one injection of 1x107/kg CD3-CD56+ cells) after chemotherapy associating fludarabine, cytosine arabinoside and cyclophosphamide.
16128395|NCT01947309|Drug|Revlimid (lenalidomide)|Revlimid (lenalidomide) as prescribed in usual clinical practice
16128396|NCT01947283|Behavioral|DECIDE-PA|The DECIDE-PA intervention teaches patients strategies for asking questions and communicating more effectively with their behavioral health care provider in order to improve shared decision making.
16128397|NCT01947283|Behavioral|DECIDE-PC|The DECIDE-PC intervention trains providers in patient-centered communication techniques and encourages providers to be receptive to patients who take a more active role during the clinical encounter in order to improve shared decision making.
16128398|NCT01947270|Other|" Optimisation de la Prescription MEDicamenteuse  (Optimization of drug prescribing)"|"The multidisciplinary intervention program include:
~Awareness and training of doctors by two experts (a geriatrician and a pharmacist) within participating departments.
~Implementation of a checklist which aims to conduct an adapted and standardized pharmaceutical analysis"
16128399|NCT01947257|Other|the measure TRVMAX|by transthoracic echocardiography
16128400|NCT01947257|Other|the measure of the pulmonary artery|by transesophageal ultrasound
16128401|NCT01947257|Other|the direct measure of the pulmonary pressures|by right catheterization
16128402|NCT01947244|Behavioral|Doula Home Visiting|The intervention is a doula enhancement to evidence-based home visiting services. Doulas provide home visits during pregnancy and for the first six weeks postpartum, which focus on prenatal health, preparation for childbirth, bonding with the baby, and breastfeeding education. Family support workers provide longer term home visiting services. These home visits focus on sensitive and responsive parenting, early infant care, bonding with the baby, child health and development, and maternal mental health.
16128403|NCT01947244|Behavioral|Case management|Mothers are offered two prenatal and two postpartum case management meetings to assess whether mothers' basic needs (housing, nutrition, health care, mental health) are being met and make appropriate referrals.
16128404|NCT01947231|Other|Global Postural Re-education|Global Postural Re-education is a physical therapy method comprising a series of gentle active movements, implemented by the therapist using manual contacts and verbal commands, to promote postural symmetry.
16128405|NCT01947231|Other|Standard manual physical therapy|Standard manual physical therapy in this study involves a combination of exercises, pompage (gentle manual techniques of distraction and articulation of a joint), anterior-posterior mobilizations as described by Maitland, and massage that have been selected to meet the needs of each individual patient.
16128406|NCT01947218|Procedure|bronchial biopsies|
16128407|NCT01947218|Other|Determination of CO in exhaled air|
16128408|NCT01947205|Drug|paracetamol|
16128409|NCT01947205|Drug|dexketoprofen trometamol|
16128410|NCT01947205|Drug|suction curettage|
16128411|NCT01947205|Drug|suction curettage|
16128412|NCT01947205|Other|without drug|
16128413|NCT01947192|Procedure|Treatment with chlorhexidine|Application of 2% chlorhexidine digluconate (60 seconds) after the etching procedure and before the adhesive system.
16128414|NCT01947192|Procedure|Water pre-treatment|Treatment of acid etched dentin with sterilized water for 60 s before adhesive system application
16128415|NCT01947179|Behavioral|Anxiety Risk Reduction|Involves psychoeducation and interoceptive exposure exercises
16128510|NCT01946438|Biological|Fluzone® High-Dose, Influenza Virus Vaccine (2013-2014 formulation)|0.5 mL, Intramuscular
16128416|NCT01947166|Dietary Supplement|Nestle Impact Advanced Recovery nutritional supplement|Before Surgery: Consume 1 drink box (8 ounces) three times a day for 5 days (15 servings total) on postoperative day minus 5 through postoperative day 1 in addition to normal diet. After Surgery: Consume 1 drink box (8 ounces) three times a day for 5 days on postoperative day 2 through postoperative day 6.
16128417|NCT01947153|Drug|Metformin|Free combination
16128418|NCT01947153|Drug|Linagliptin|Fixed dose combination
16128419|NCT01947153|Drug|Metformin|Combination
16128420|NCT01947153|Drug|Linagliptin|Free combination
16128421|NCT01947140|Drug|Pralatrexate|"Phase I - Schedule A: Intravenous drug given on days 1 and 8 of each 21 day cycle Schedule B: Intravenous drug given on days 1 and 15 of each 28 day cycle Dose escalation from 10 mg/m2 to 25 mg/m2
~Phase II - 25 mg/m2 will be given intravenously once weekly on days 1 and 15 on a 28 day cycle."
16128422|NCT01947140|Drug|Romidepsin|"Phase I - Schedule A: Intravenous drug given on days 1 and 8 of each 21 day cycle Schedule B: Intravenous drug given on days 1 and 15 of each 28 day cycle Dose escalation from 12 mg/m2 to 14 mg/m2.
~Phase II - 12 mg/m2 will be given intravenously once weekly on days 1 and 15 on a 28 day cycle."
16128423|NCT01947114|Drug|Propofol|
16128424|NCT01947114|Drug|Ketamine|
16128425|NCT01947114|Drug|Remifentanil|
16128426|NCT01947101|Biological|Fecal Microbiota Transplant|Fecal Microbiota Transplant will be endoscopically administered directly into the colon. Consecutive treatments will be given by rectal enema route.
16128427|NCT01947088|Behavioral|Music Therapy|Will consist of meeting with the music therapists, Certified Child Life Specialists (CCLS), or Child Life Assistants (CLA) for either music therapy for about 45 minutes, twice per week, for Weeks 1-8. The Music Therapy group will partake in interventions such as singing and playing musical instruments. All brain surgery candidates receive a neuropsychological assessment before and after surgery (9-12 months after surgery). In addition, patients who agree to participate in the study will receive cognitive screening and a music therapy evaluation prior to surgery (Baseline 1). These evaluations will also be given within 3 days of epilepsy surgery (Baseline 2), 8 weeks after surgery (Baseline 3), and 9-12 months after surgery (Baseline 4.)
16128428|NCT01947062|Drug|Intravenous Cisplatin & etoposide|Patients will receive standard intravenous cisplatin and etoposide based chemotherapy, for a total of six cycles, delivered at three-weekly intervals. In each cycle, the dose of cisplatin will be at 50mg/m2 on days 1 & 2. The dose of etoposide will be 100mg/m2 on days 1, 2 & 3.
16128429|NCT01947062|Drug|Intravenous Cisplatin & etoposide along with oral cyclophosphamide|Patients will be treated with oral cyclophosphamide at a daily dose of 50mg. Patients will also receive standard intravenous cisplatin and etoposide based chemotherapy, for a total of six cycles, delivered at three-weekly intervals. In each cycle, the dose of cisplatin will be at 50mg/m2 on days 1 & 2. The dose of etoposide will be 100mg/m2 on days 1, 2 & 3.
16128430|NCT01947049|Other|Rapid Influenza Testing with Xpert Flu|Participants with recieve rapid influenza testing with Xpert Flu
16128431|NCT01947023|Drug|Dabrafenib|Given PO
16128432|NCT01947023|Drug|Dabrafenib Mesylate|Given PO
16128433|NCT01947023|Drug|Lapatinib|Given PO
16128434|NCT01947023|Drug|Lapatinib Ditosylate|Given PO
16128435|NCT01947010|Biological|Prevenar 13|
16128436|NCT01947010|Biological|Pneumovax|
16128437|NCT01946997|Other|OCT Imaging both Normal and diabetic groups|Images taken to determine thickness values in the retina
16128438|NCT01946984|Procedure|ERCP|endoscopy, retrograde cholangio-pancreaticography.
16128439|NCT01946984|Drug|Diclofenac hydroxyethylpyrrolidine|
16128440|NCT01946984|Drug|Normal Saline|
16128441|NCT01946971|Drug|Lansoprazole|
16128442|NCT01946971|Drug|Placebo|
16128443|NCT01946958|Behavioral|Training in PC Triple P|PC Triple P is a brief parenting intervention combining specific advice from provider with parent rehearsal and self-evaluation.
16128444|NCT01946958|Other|Care As Usual|Pediatric residents not exposed to PC Triple P provide their standard care to parents struggling with parenting issues or child behavior concerns.
16128445|NCT01946945|Genetic|Next Generation Sequencing after Blastocyst biopsy|PGD using blastocyst biopsy and testing of the biopsy by NGS
16128446|NCT01946932|Other|Temperature treatment|
16128447|NCT01946906|Drug|Rifaximin|
16128448|NCT01946893|Behavioral|Mindfulness Meditation|A standardized and structured program based on Mindfulness Based Cognitive Therapy and Mindfulness Based Stress Reduction and has been piloted in our laboratory.Each session included 1) discussion on stress, relaxation, meditation, and mind-body interaction, 2) instruction and practice in formal and informal MM, and 3) enquiry about problem-solving techniques regarding success and difficulty in practicing mindfulness. Formal meditation instruction included a mindful Body Scan and Sitting Meditation (awareness of breath, body sensations, cognitive and emotional processes). Informal practice of mindful daily activities (e.g., washing dishes) was also taught to generalize mindfulness beyond the formal meditations. A 3-minute meditation was offered as a quick coping strategy, and it could be practiced with or without a guided recording.
16128449|NCT01946893|Behavioral|Education|The Education control was matched for session time and home practice. The internet sessions included a general health video and questions about the material. For home practice, the participants listened to podcasts about the same topic. The session topics were 1) Healthy Eating, 2) Healthy Exercise, 3) Healthy Sleep, 4) Healthy Brain, 5) Healthy Mood, and 6) Community Involvement.
16128450|NCT01946880|Drug|Mycophenolate Mofetil|Subjects will enter the trial on 1000-3000 mg/day of MMF and will be randomized to remain on MMF treatment or to be tapered off MMF within 12 weeks.
16128451|NCT01946880|Drug|Hydroxychloroquine or Chloroquine|Subjects will be on concurrent anti-malarial agents (hydroxychloroquine or chloroquine). Hydroxychloroquine is approved by the FDA for the treatment of SLE. Hydroxychloroquine has been shown to help prevent flare in SLE, and to improve skin and musculoskeletal activity in particular.Even lupus nephritis outcomes appear improved on a background of hydroxychloroquine therapy
16128452|NCT01946880|Drug|Prednisone|Once the subject is randomized into the trial, the prednisone (or other corticosteroid) dose must be stable through Week 36 (24 weeks following protocol taper of MMF), in the absence of flares as described in Section 3.2 of the study protocol, Description of Primary Endpoint. Further taper of prednisone after that point is by the investigator's discretion based on the subject's clinical status.
16128453|NCT01946867|Device|NBTXR3 activated by IMRT|
16128454|NCT01946854|Behavioral|Questionnaire|"Completion of 3 questionnaires at baseline and at final visit about quality of life, and 1 questionnaire about symptoms, diagnosis, treatment, prognosis, and patient's relationship with caregivers. These will take about 35-50 minutes to complete.
~Completion of 3 quality of life questionnaires every 3 months for 1 year."
16128455|NCT01946841|Dietary Supplement|RealDiet®Renal|
16128456|NCT01946828|Device|FIM|Field Induced Mydriasis device
16128457|NCT01946815|Drug|Atorvastatin|Lipitor dose titration will be followed by the result of LDL lab test until it meets the target level of LDL. IVUS(optional) and FFR during follow up CAG in 12 months will be measured to evaluate the effect of lipitor.
16128458|NCT01946802|Device|Frontal 4 channel EEG|Simultaneous conventional EEG and SEDline monitoring for 30 minutes during and after therapeutic hypothermia
16128459|NCT01946789|Biological|ALT-803|Intravenous infusion for dose level 1-5; subcutaneous injection for dose level 5a-8; two 6-week treatment cycles: ALT-803 on Day 1, 8, 15, 22; stable or benefitting patients may receive up to two additional 6-week cycles
16128460|NCT01946776|Device|implantable heart rate monitor|Implantation of Reveal XT
16128461|NCT01946763|Behavioral|pre operative education|Patients will be randomized in 2 groups (G1: educated, G2:non-educated) In the operating room and before starting anesthesia G1 will receive a pre operative education about anesthesia emergence, recovery and extubation.
16128462|NCT01946763|Behavioral|pre operative education|
16128463|NCT01946750|Biological|Serum|
16128464|NCT01946750|Biological|Stools|
16128465|NCT01946750|Biological|Saliva|Optional sample collected for the cases and non-diarrheal control at the same time as the serum, to compare the presence of specific salivary Immune globulin type A (IgA) of C. difficile antibodies than in the serum.
16128466|NCT01946750|Biological|Whole blood|Optional sample collected for the cases and non-diarrheal control at the same time as the serum, in order to study cellular immunity and describe the determinants of the development of a protective adaptive response.
16128467|NCT01946737|Radiation|HD-CTCA with Adaptive statistical iterative reconstruction (ASIR)|
16128468|NCT01946737|Radiation|Active Comparator: Invasive coronary angiography (ICA)|
16128469|NCT01946711|Drug|Budesonide|Inhalation
16128470|NCT01946711|Drug|Budesonide|Nasal spray
16128471|NCT01946672|Procedure|Lower-limb drainage isotopic intraoperative detection|A radiopharmaceutical is injected into both feet on the day before surgery. Pelvic lower-limb drainage nodes (LLDNs) are identified using preoperative SPECT-CT and intraoperative isotopic probe detection, and then electively removed before complete pelvic lymphadenectomy. LLDNs and pelvic lymphadenectomy specimens undergo separate histological analysis.
16128472|NCT01946659|Behavioral|Adherence to Sleep Apnea Treatment|A health education material prepared after focus group discussion with community leaders and patients would be administered to the participants with an experienced health educator through phone. Upto 10 calls per each patient will be made to either group until 6 months or the patient has a sleep test done.
16128473|NCT01946659|Other|Standard Care Group|The standard care group gets a standard print communications about sleep apnea produced by NLHBI and American Academy of Sleep Medicine
16128474|NCT01946646|Drug|S-1-CCRT|
16128475|NCT01946633|Device|magnetic-controlled capsule endoscopy(Navicam)|
16128476|NCT01946620|Drug|Flutiform|
16128477|NCT01946620|Drug|Formoterol|
16128478|NCT01946607|Drug|Citalopram|
16128479|NCT01946607|Drug|Placebo|
16128480|NCT01946594|Other|Acetaminophen|
16128481|NCT01946594|Other|Placebo|
16128482|NCT01946581|Procedure|Cataract Surgery|
16128483|NCT01946568|Drug|Dalbavancin|Intravenous dalbavancin given at 15 mg/kg (not to exceed 1000 mg) for patients ≥5 years of age, and 25 mg/kg for patients <5 years of age.
16128484|NCT01946555|Drug|Morphine|
16128485|NCT01946555|Drug|Fentanyl|
16128486|NCT01946555|Drug|Methadone|
16128487|NCT01946555|Drug|Buprenorphine|
16128488|NCT01946555|Drug|Oxycodone|
16128489|NCT01946555|Drug|Hydromorphone|
16128490|NCT01946555|Drug|Tapentadol|
16128491|NCT01946542|Drug|beet juice concentrate|single dose of beet juice concentrate, roughly 70 mL
16128492|NCT01946542|Other|placebo|
16128493|NCT01946529|Drug|vincristine|Dosage and route of administration: Infants < 12 months of age: 0.05 mg/kg IV day 1; participants ≥ 12 months of age: 1.5 mg/m^2 IV day 1 (max. dose 2 mg).
16128494|NCT01946529|Drug|doxorubicin|Dosage and route of administration: Infants < 1 year 2.5 mg/kg continuous infusion (CI) over 48 hours, days 1-2; participants > 1 year of age 75 mg/m^2 CI over 48 hours, days 1-2.
16128495|NCT01946529|Drug|cyclophosphamide|Dosage and route of administration: The dose and route are different in neo-adjuvant/adjuvant chemotherapy and maintenance therapy. Please see the Detailed Description for further information.
16128496|NCT01946529|Drug|ifosfamide|Dosage and route of administration: Infants < 1 year of age 60 mg/kg/day IV over 60 minutes days 1-5; participants > 12 months of age 1800 mg/m^2 IV over 60 minutes x 5 days, days 1-5.
16128497|NCT01946529|Drug|etoposide|Dosage and route of administration: Infants < 1 year of age 3.3 mg/kg/day IV over 60 minutes days 1-5; children > 1 year 100 mg/m^2 daily IV over 60 minutes days 1-5.
16128498|NCT01946529|Drug|temozolomide|Dosage and route of administration: Temozolomide 100 mg/m^2 PO once daily, days 1-5.
16128499|NCT01946529|Drug|temsirolimus|Dosage and route of administration: Temsirolimus 35 mg/m^2 IV once day 1 and day 8.
16128500|NCT01946529|Drug|bevacizumab|Dosage and route of administration: Bevacizumab 15 mg/kg IV on day 1 every 3 weeks.
16128501|NCT01946529|Drug|sorafenib|Dosage and route of administration: 90 mg/m^2/dose PO BID
16128502|NCT01946529|Procedure|surgery|If participant meets the criteria, they will have surgical resection of their tumor.
16128503|NCT01946529|Radiation|radiation|If the participant meets the criteria, participants will receive radiation therapy. Chemotherapy will continue during radiation.
16128504|NCT01946477|Drug|Pomalidomide|
16128505|NCT01946477|Drug|Dexamethasone|
16128506|NCT01946477|Drug|Daratumumab|
16128507|NCT01946438|Biological|Fluzone® Quadrivalent, Influenza Virus Vaccine (2013-2014 formulation),|0.5 mL, Intramuscular
16128508|NCT01946438|Biological|Fluzone® Intradermal, Influenza Virus Vaccine (2013-2014 formulation),|0.1 mL, Intradermal
16128511|NCT01946425|Biological|Fluzone® Quadrivalent Influenza Virus Vaccine, No Preservative|0.25 mL, Intramuscular (Pediatric Dose, 2013-2014 formulation)
16128512|NCT01946425|Biological|Fluzone® Quadrivalent Influenza Virus Vaccine, No Preservative|0.5 mL, Intramuscular (2013-2014 formulation)
16128513|NCT01946412|Drug|Ivacaftor|
16128514|NCT01946399|Drug|Ozurdex implant|Intravitreal injection of Dexamethasone implant
16128515|NCT01946386|Drug|LEO 90100 Aerosol, foam|The products will be applied on 6 test sites (according to random assignment to specific test sites predetermined on their anterior face of forearms) for 6 hours
16128516|NCT01946386|Drug|Betamethasone dipropionate in LEO 90100 Aerosol, foam, vehicle|
16128517|NCT01946386|Drug|LEO 90100 Aerosol, foam, vehicle|
16128518|NCT01946386|Drug|Daivobet® ointment|
16128519|NCT01946386|Drug|Dermovate® cream|
16128520|NCT01946386|Drug|Synalar® ointment|
16128521|NCT01946373|Drug|Cyclophosphamide|
16128522|NCT01946373|Drug|Fludarabine|
16128523|NCT01946373|Biological|T cells|
16128524|NCT01946373|Biological|Interleukin-2|
16128525|NCT01946373|Biological|Dendritic cell vaccine|
16128526|NCT01946360|Device|Methacetin Breath Test in ACLF and ALF patients|Methacetin Breath Test will be done on Day 0,7,14,28 in Acute on Chronic Liver Failure (ACLF)and on day 0,1,3,7 in Acute Liver failure (ALF).
16128527|NCT01946347|Other|mixed meal|"Baguette Cheese Gourmet (Crocodile:
~180g, energy 452.8 Kcal, composition: carbohydrates 49,2 g (44,55%), proteins 18,5 g (16,74%), lipids 18,8 g (38,7%), of which saturated 6,8 g, monounsaturated 6,0 g, polyunsaturated 5,0 g."
16128528|NCT01946347|Other|Acute in vivo induced hyperinsulinemia|Hyperinsulinemic (1mU/kg/min) euglycemic clamp 3 hours long
16128529|NCT01946334|Device|anorectal manometry and high-resolution three-dimensional|
16128530|NCT01946321|Other|Post-amputation functional rehabilitation (normal clinical practice)|
16128531|NCT01946308|Other|Conformational positioning system|The conformational positioning system will be compared to the standard infant crib mattress.
16128532|NCT01946295|Drug|Famotidine|100mg x 2 p.o.
16128533|NCT01946295|Drug|Placebo|
16128534|NCT01946282|Other|FIT Invitation Only|Patients meeting the inclusion / exclusion criteria are mailed invitations to complete a free colorectal cancer screening. POLYMEDCO Fecal Immunochemical Tests (FIT) are mailed to patient homes with instructions, followed up with live and TELEVOX reminder phone calls.
16128535|NCT01946282|Other|FIT plus $5 Incentive|Patients meeting the inclusion / exclusion criteria are mailed invitations to complete a free colorectal cancer screening. POLYMEDCO Fecal Immunochemical Tests (FIT) are mailed to patient homes with instructions, followed up with live and TELEVOX reminder phone calls. Patients are offered a small incentive to complete their screening.
16128536|NCT01946282|Other|FIT plus $10 Incentive|Patients meeting the inclusion / exclusion criteria are mailed invitations to complete a free colorectal cancer screening. POLYMEDCO Fecal Immunochemical Tests (FIT) are mailed to patient homes with instructions, followed up with live and TELEVOX reminder phone calls. Patients are offered a small incentive to complete their screening.
16128537|NCT01946269|Other|Goal-directed Resuscitation Therapy (GDT)|"A target value of a cardiac index (CI) greater than 2.5 L/min/m2 and a mean arterial pressure of 70 mmHg will be sought.
~The first step will be fluid resuscitation with 200ml aliquots of Lactated Ringer's solution plus human albumin 20% 50 mL whenever the CI is lower than 2.5 L/min/m2. The fluid challenge will be stopped if the CVP rises by more than 4 mmHg during the infusion period or CI increases less than 10%.
~When the CI is lower than or equal to 2.5L/min/m2 despite of fluid challenge, dobutamine will be initiated with increasing doses up to 20mcg/kg/min.
~The final step will be red blood transfusion to reach a hematocrit higher than 28%.
~If necessary, norepinephrine infusion will be used to maintain a mean arterial pressure above 70 mmHg."
16128538|NCT01946269|Other|Standard protocol|The control group will be managed by the surgical ICU staff in the postoperative period according to institutional protocol of hemodynamic monitoring.
16128539|NCT01946256|Drug|Amoxicillin|
16128540|NCT01946256|Drug|Erythromycin|
16128541|NCT01946243|Drug|Florbetapir F18|No Florbetapir F 18 will be administered in this study.
16128542|NCT01946217|Other|questionnaire administration|Ancillary studies
16128543|NCT01946204|Drug|Apalutamide|240 mg tablets administered by mouth on a continuous once daily dosing regimen
16128544|NCT01946204|Drug|Placebo|Matched placebo tablets administered by mouth on a continuous once daily dosing regimen
16128545|NCT01946191|Behavioral|24 months of personalized coaching through the EHR patient portal, with 24 scheduled contacts.|Participants were assigned to a specific coach, who contacted the participants via the EHR weekly for 1 month, biweekly in months 2 to 6, monthly in months 7 to 12, and quarterly in months 13 to 24, for a total of 24 scheduled contacts. Coaching group participants received brief questionnaires relevant to weight management, including a text field where they could discuss questions or barriers. On the basis of participant responses and self-monitoring data in the EHR flow sheets, coaches wrote a brief personalized note with advice on questionnaire topics and responses to any queries or barriers mentioned by the participant. Coaching participants who did not complete questionnaires or log information into the flow sheet for 2 weeks were considered inactive and were contacted by telephone or e-mail and invited to reengage at any time. Coaching participants were able to send secure messages to the coach.
16128546|NCT01946191|Behavioral|Online self-monitoring|Participants were encouraged to log in daily and enter data on weight, diet, and physical activity.
16128547|NCT01946191|Behavioral|Real-time updates to Primary Care physicians|Referring PCPs of coaching group participants received regular support, including real-time progress reports with counseling tips delivered via the EHR, notification of weight change in increments of at least 10 pounds, and annual progress reports at 12 and 24 months.
16128548|NCT01946178|Device|Mirabilis High-Intensity Focused Ultrasound Treatment System|The intervention consists of a treatment session with the device, during which focused ultrasound energy is applied across the intact abdominal wall to ablate appropriately selected uterine fibroids under ultrasound imaging guidance.
16128549|NCT01946165|Drug|Abiraterone Acetate|1,000 mg by mouth daily for each 28 day cycle.
16128550|NCT01946165|Drug|Prednisone|5 mg by mouth once daily for each 28 day cycle.
16128551|NCT01946165|Drug|Enzalutamide|160 mg by mouth daily for each 28 day cycle.
16128597|NCT01945840|Procedure|Roux en Y Gastric Bypass Surgery|
16128552|NCT01946165|Drug|LHRHa|Patients receive a LHRHa (monthly injection or three-month injection) for a maximum of 7 months before a prostatectomy is performed. Study doctor will decide what hormone therapy patient receives.
16128553|NCT01946152|Drug|Dexamethasone|Given PO
16128554|NCT01946152|Biological|Filgrastim-sndz|Given SC
16128555|NCT01946152|Other|Laboratory Biomarker Analysis|Correlative studies
16128556|NCT01946152|Drug|Pomalidomide|Given PO
16128557|NCT01946139|Procedure|comparison of screening methods|Undergo HPV screening using HC2, APTIMA and OncoHealth HPV E6/E7 assays
16128558|NCT01946139|Other|laboratory biomarker analysis|Correlative studies
16128559|NCT01946139|Other|questionnaire administration|Ancillary studies
16128560|NCT01946139|Procedure|quality-of-life assessment|Ancillary studies
16128561|NCT01946126|Other|No Intervention|There is no intervention in this study.
16128562|NCT01946100|Genetic|Multifocal Lung Adenocarcinoma|Tissue collection at the time of surgery for genetic testing and blood sample for germ line DNA.
16128563|NCT01946087|Procedure|Remote ischemic preconditioning at left upper arm|Placement of automated cuff-inflator on the left upper arm after induction of anesthesia RIPCgroup-3 cycles of 5 min ischemia (300 mmHg inflation) & 5 min reperfusion (deflation)
16128564|NCT01946087|Procedure|Control group|keeping the cuff deflated
16128565|NCT01946074|Drug|paclitaxel|Paclitaxel will be administered by intravenous infusion.
16128566|NCT01946074|Drug|FOLFIRI|5-fluorouracil, Folinic acid and Irinotecan will be administered by intravenous infusion.
16128567|NCT01946074|Drug|ABT-165|ABT-165 will be administered by intravenous infusion at escalating dose levels.
16128568|NCT01946074|Drug|ABBV-181|ABBV-181 will be administered by intravenous infusion.
16128569|NCT01946061|Drug|S-1 plus oxaliplatin|Patients will receive adjuvant chemotherapy of eight 3-week cycles of oral S-1 (70 mg/m2/day on days 1 to 14 of each cycle) plus intravenous oxaliplatin (130 mg/m2 on day 1 of each cycle) for 6 months after D2 gastrectomy.
16128570|NCT01946048|Biological|mesenchymal stem cells|"Procedure: Selected patients were randomly divided into a cell therapy group and a control group.
~Umbilical Cord Blood Derived Mesenchymal Stem Cells at a dose of 150-250 million."
16128571|NCT01946035|Drug|Doxazosin XL|
16128572|NCT01946035|Other|Placebo|
16128573|NCT01946022|Drug|randomization between the two GnRH analogues (agonist and antagonist)|
16128574|NCT01946009|Drug|Cidofovir 1% cream's basis, 2gr, three times per week, during 4 weeks.|
16128575|NCT01945996|Behavioral|TExT MED|educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone
16128576|NCT01945996|Behavioral|FANS|supporter curriculum of messages, consisting of educational/motivational messages, and support challenges
16128577|NCT01945983|Drug|Early norepinephrine|Initiation of norepinephrine, a strong vasoconstrictor, at the initiation of septic shock management, together with fluid resuscitation.
16128578|NCT01945983|Drug|Placebo|5% dextrose water intravenous drip in the same rate of calculated norepinephrine for the patient's body weight
16128579|NCT01945970|Other|Black tea extract|Black tea extract
16128580|NCT01945970|Other|Positive control|Positive control
16128581|NCT01945970|Other|Placebo|Placebo
16128582|NCT01945957|Drug|Oxytocin|"For Phase I, subjects will be randomized to receive either 24IU (6 sprays) of active oxytocin or 6 sprays of placebo (3 sprays per nostril)
~For Phase II, subjects will be randomized to receive either 8 IU or 40 IU of oxytocin."
16128583|NCT01945944|Drug|Hypertonic saline (3%)|3mL of HTS given via nebulizer every 6hrs
16128584|NCT01945944|Drug|Placebo (0.9% saline)|3mL of normal saline given via nebulizer every 6hrs
16128585|NCT01945931|Other|Safe Delivery Smartphone Application|The safe delivery smartphone application is designed to train midwives and other birth attendants in developing countries in management of normal and complicated deliveries. The application is furthermore intended as a reference tool that could be used during clinical work for example for preparation before attending a birth, in a situation when a complication occurs, or for debriefing and self-evaluation after a complication. The application features four animated videos with clinical instructions of 3-8 minutes duration and written lists of essential obstetric drugs (indications, contraindications, dosage and administration and side effects) and essential equipment for a safe delivery.
16128586|NCT01945918|Behavioral|Self-management support education|Same as Arm Description
16128587|NCT01945918|Behavioral|Connection to Health Interactive Behavior Change Technology|Same as Arm Description
16128588|NCT01945918|Behavioral|Connection to Health plus Coaching (CTH+C)|Same as Arm Description
16128589|NCT01945905|Other|Intramural|Under this alternative, the patients will receive treatment with direct observation from health team. Treatment will be provided for free
16128590|NCT01945905|Other|Extramural|In this form the medication will be given by a health worker in the place chosen by patients. This option will be delivered to patients with newly diagnosed pulmonary TB without hospitalization criteria
16128591|NCT01945892|Drug|Ozurdex|"- Consent agreement - Patients should be informed that it is possible to get an active medication (Ozurdex implant) as an on label indication from the health insurance company if the diagnosis is accepted as an intraocular inflammation form of Uveitis posterior."
16128592|NCT01945879|Drug|Enoxaparine|al patients received additional low molecular heparin, if the safety cohort of three patients received at least 4 weeks of combined treatment without severe side effects, recruitment were continued until a minimum of 15 patients completed at least 3 months of treatment.
16128593|NCT01945866|Drug|intravitreal ranibizumab 0.3 mg|Intravitreal injection of 0.3mg ranibizumab performed on the day of randomization and up to every 4 weeks using defined treatment criteria
16128594|NCT01945866|Drug|dexamethasone intravitreal implant|The dexamethasone intravitreal injection will be given within 0-8 days of the ranibizumab injection. If defined criteria are met, a second dexamethasone injection in combination with intravitreal ranibizumab (within 0-8 days) will be given at the 12 week visit. If the injections are given consecutively on the same day, the ranibizumab injection must be given first.
16128595|NCT01945866|Procedure|Sham injection|No injection is given. It is a sham injection to keep the participant masked. The sham injection will be given within 0-8 days of the ranibizumab injection. If the injections are given consecutively on the same day, the sham injection must be given first.
16128596|NCT01945853|Device|7 Tesla MRI|
16128600|NCT01945840|Other|Very low calorie diet|
16128601|NCT01945827|Device|DeltaMaxx Microcoil System|
16128602|NCT01945814|Drug|CTL for CMV seropositive donors|CTL for CMV seropositive donors-Allogeneic Multivirus Directed Cytotoxic T lymphocytes (CTL) targeting CMV (IE1 and pp65), EBV (LMP2, EBNA1), and Adv (Hexon and Penton) for CMV seropositive donors dose is depending on the toxicity outcome, the maximum sample size for the this phase I portion of the trial is 14. Upon the completion of mCTL safety evaluation, additional 7 patients will be accrued at the MTD level to evaluate its antiviral activity.
16128603|NCT01945814|Drug|CTL for CMV naïve donors|CTL for CMV naïve donors - Allogeneic Multivirus - Directed Cytotoxic T lymphocytes (CTL) targeting CMV (IE1 and pp65), EBV (LMP2, EBNA1), and Adv (Hexon and Penton) for CMV naïve donors dose is depending on the toxicity outcome, the maximum sample size for the this phase I portion of the trial is 14. Upon the completion of mCTL safety evaluation, additional 7 patients will be accrued at the MTD level to evaluate its antiviral activity.
16128604|NCT01945801|Drug|Lasilactone|Active drug (spironolactone 100 mg plus furosemide 20 mg).
16128605|NCT01945801|Other|Sodium-Restricted Diet|The sodium-restricted diet will enforce some rules: do not use salt in cooking; do not use the salt shaker; do not ingest any industrialized food; to eat fresh salads and vegetables; do not add high-sodium seasonings, among others. The complete dietary rules will be delivered to each volunteer in a four page handout.
16128606|NCT01945801|Drug|Placebo|The placebo group will receive cellulose-based placebo pills with identical pills and flasks to active drug.
16128607|NCT01945788|Drug|Teriparatide (rDNA origin)|
16128608|NCT01945775|Drug|talazoparib|Until progression or unacceptable toxicity develops
16128609|NCT01945775|Drug|Physician's-Choice|Capecitabine, Eribulin, Gemcitabine or Vinorelbine
16128610|NCT01945762|Drug|Vandetanib 300 mg|Vandetanib commercial tablets
16128611|NCT01945749|Drug|Intraarticular steroid|1 ml methylprednisolon corticosteroid (40 mg Depo-Medrol®) mixed with 4 ml Lidocain (10 mg/ml) without adrenalin. Injections are done ultrasound guided.
16128612|NCT01945749|Drug|Intraarticular saline|1 ml isotonic saline mixed with 4 ml Lidocain (10 mg/ml) without adrenalin. Injections are done ultrasound guided
16128613|NCT01945749|Other|Exercise therapy|"The exercise is commenced 2 weeks after injection.
~The exercise includes a 10 minute warm up phase (ergometer bicycling) followed by strengthening and coordination exercises focusing on trunk, hip and knees.
~In case of pain or symptom exacerbation, a rescue exercise program is administered, excluding weight bearing activities."
16128614|NCT01945736|Drug|Methadone|To determine the PK of enteral methadone in children > or = 90 days and <18 years treated for opiate withdrawal per routine medical care.
16128615|NCT01945710|Drug|Eribulin-LF|
16128616|NCT01945684|Drug|Botulinum toxin type A|Maximum dose 360 U
16128617|NCT01945645|Behavioral|Ready to act|The Ready to Act programme aimed to promote health-related action competence including motivation, informed decision-making, action experience and social involvement The intervention was delivered across a number of primary care settings including the GP office, health centre and pharmacy. The programme consisted of two individual counselling interviews and eight group sessions, which totalled 18 hours within a three month period.
16128618|NCT01945632|Device|conventional gracey curettes|
16128619|NCT01945632|Device|Vertically oscillating ultrasonic device|
16128620|NCT01945632|Device|piezoelectric ultrasonic scraper|
16128621|NCT01945619|Biological|Trivirus-Specific CTLs|Patients will receive up to 2 x 10^7 CHM-CTL/m2 as a single infusion and may receive up to 4 additional infusions at intervals of at least 2 weeks.
16128622|NCT01945606|Drug|Placebo (treatment 1)|Oral administration of placebo tablets
16128623|NCT01945606|Drug|BAY1067197 (treatment 2)|Oral administration of a single dose of 30 mg (3×10 mg Tablet) BAY1067197
16128624|NCT01945593|Biological|BAX855|Antihemophilic Factor (Recombinant), PEGylated
16128625|NCT01945580|Procedure|Prolapse Repair|Transvaginal anterior/apical pelvic organ prolapse repair
16128626|NCT01945567|Device|Up to 3 mA, 60 us, 130 Hz deep brain stimulation|
16128627|NCT01945567|Device|Empirical unblinded deep brain stimulation programming|
16128628|NCT01945554|Procedure|Cervical nerve root infiltration|4mg Mephamesone followed by 1ml of 0.5% bupivacaine (Bupivacain®) will be administered.
16128629|NCT01945554|Procedure|Lumbar nerve root infiltration|40mg triamzinolone (Kenacort®) followed by 2ml of 0.5% bupivacaine (Bupivacain®) will be administered.
16128630|NCT01945554|Drug|Mephamesone|
16128631|NCT01945554|Drug|0.5% bupivacaine (Bupivacain®)|
16128632|NCT01945554|Drug|Kenacort®|
16128633|NCT01945541|Device|Body Composition Monitoring|Pre- and postoperative measurements of body composition (intracellular and extracellular water content)via bioimpedance spectroscopy
16128634|NCT01945528|Drug|US-guided tenotomy with PRP|"Blood will be drawn from the patient from the patient's unaffected arm. the anti-coagulated blood will be centrifuged and pure-PRP (without leukocytes) collected.
~Local anesthetic (lidocaine) will be infiltrated into the subcutaneous tissue of the lateral elbow, after which a single skin portal and multiple longitudinal and transversal penetrations of the tendon will be performed; PRP will be delivered in multiple depots during the procedure"
16128635|NCT01945528|Drug|US-guided tenotomy with lidocaine|Blood will be drawn from the patient from the patient's unaffected arm. Local anesthetic (lidocaine) will be infiltrated into the subcutaneous tissue of the lateral elbow, after which a single skin portal and multiple longitudinal and transversal penetrations of the tendon will be performed; lidocaine will be delivered in multiple depots during the procedure
16128636|NCT01945515|Device|tDCS|tDCS will be applied on the primary motor cortex of the lower limb in the impared hemisphere before robotic-assisted gait training. Anodal tDCS will be applied with an intensity of 2mA for 20 min. Sham tDCS will be applied with an intensity of 2mA just for 1 min, after which the current will be slowly tapered down to 0 over a several seconds.
16128637|NCT01945515|Device|Robotic-assisted gait training|Robotic-assisted gait training with an exoskeletal type robot which simulates normal walking on a treadmill for patients with gait impairments
16128638|NCT01945489|Biological|onabotulinumtoxinA|OnabotulinumtoxinA (BOTOX®) injected into the detrusor.
16128639|NCT01945489|Drug|Normal saline|Normal saline (placebo) injected into the detrusor.
16128813|NCT01943864|Drug|Trametinib (Multiple tablet)|The drug substance is blended with inert
16129266|NCT01940263|Dietary Supplement|Anthocyanin|
16128640|NCT01945476|Drug|midazolam premedication|"On the day when patients are scheduled for operation, one researcher will use a computer to randomly select and allocate patients. By randomization, patients will be divided into two groups, receiving an injection of either 0.02 mg/kg of midazolam(midazolam group) or saline (control group). The researcher who randomly allocated patients will prepare the medicines but not just medicine. Investigators must mix it with normal saline to obtain a total volume of 5 mL and label two of them all prepared medicine, never letting the doctors and subjects know which is midazolam and which is saline.
~Use the QoR-40 survey form to investigate the functional recovery of the patient. This survey will be administered before the operation and on the first and second days after the operation; it will be administered three times in total."
16128641|NCT01945450|Drug|Antibiotic prophylaxis|antibiotic prophylaxis as following: 24 hours coverage with Ampicillin 2 grams*4, Gentamycin 240 mg*1, Clindamycin 600 mg*3
16128642|NCT01945450|Drug|Ampicillin|
16128643|NCT01945450|Drug|Gentamycin|
16128644|NCT01945450|Drug|Clindamycin|
16128645|NCT01945437|Drug|Magnesium Sulfate|The magnesium group receive intravenous magnesium sulfate.
16128646|NCT01945424|Biological|Quadrivalent Influenza Vaccine (QIV)|No Intervention as part of this protocol
16128647|NCT01945411|Device|the length between incisor and mandible angle|the use of oropharyngeal airway (Guedel-type color coded oropharyngeal airway, Hudson RCI, Teleflex Medical, Research Triangle Park, NC) which size is the length between incisor and mandible angle
16128648|NCT01945411|Device|the length between mouth corner-mandible angle|the use of oropharyngeal airway (Guedel-type color coded oropharyngeal airway, Hudson RCI, Teleflex Medical, Research Triangle Park, NC) of which size is the length between mouth corner and mandible angle
16128649|NCT01945398|Other|Inspiratory Muscle Training|Patients will receive IMT for 30 min, 7 times per week, for 8 weeks using Inspiratory Muscle Trainer device (PowerBreath Inc.). During training, patients will be instructed to maintain diaphragmatic breathing, with a breathing rate at 15 to 20 breaths/min. Inspiratory load was set at 30% of maximal static inspiratory pressure, and weekly training loads were adjusted to maintain 30% of the PImax. Each week, six training sessions were performed at home and one training session was supervised at the hospital.
16128650|NCT01945398|Other|SHAM|Patients will receive SHAM training for 30 min, 7 times per week, for 8 weeks using Inspiratory Muscle Trainer device (PowerBreath Inc.) without load. Patients will be instructed to maintain diaphragmatic breathing, with a breathing rate at 15 to 20 breaths/min. Each week, six training sessions were performed at home and one training session was supervised at the hospital.
16128651|NCT01945385|Behavioral|Video intervention|Brief 7 minute video of physician describing LARC methods followed by two patient testimonials about their own postabortal LARC experience.
16128652|NCT01945372|Other|EEG NeuroFeedback|
16128653|NCT01945346|Drug|PRX167700|Oral capsule
16128654|NCT01945346|Drug|Placebo|Oral capsule
16128655|NCT01945333|Behavioral|Cognitive remediation|Cognitive remediation sessions include working on computer based cognitive exercises and participating in a verbal discussion.
16128656|NCT01945294|Drug|Boceprevir|800 mg three times daily orally
16128657|NCT01945294|Biological|Peg-interferon alfa-2b|1.5 mcg/kg weekly subcutaneously
16128658|NCT01945294|Drug|Ribavirin|800-1400 mg twice-daily divided orally based on body weight
16128659|NCT01945281|Drug|Caspofungin|
16128660|NCT01945281|Drug|Amphotericin B Deoxycholate|
16128661|NCT01945268|Drug|inactivated trivalent influenza vaccine|0.5 ml dose injected intramuscularly
16128662|NCT01945268|Other|Sterile saline|0.5 ml dose injected intramuscularly
16128663|NCT01945242|Drug|Alogliptin|Alogliptin tablets
16128664|NCT01945216|Drug|Alogliptin|Alogliptin tablets
16128665|NCT01945190|Device|Electroacupuncture|
16128666|NCT01945177|Device|narrow band imaging|narrow band imaging
16128667|NCT01945177|Device|white light endoscopy|white light endoscopy
16128668|NCT01945164|Drug|XL999|The treatment will consist of 4-week cycles in which the subject will receive XL999 administered as a 4-hour IV infusion every other week. The subject will continue to receive 4-week cycles of XL999 in the absence of progressive disease, unacceptable drug-related toxicity, and as long as the drug is available.
16128669|NCT01945151|Other|Group 2 (G2) NMES is applied in the spastic muscle (gastrocnemius).|The G2 apply NMES in the gastrocnemius motor point and the rest will be done during stretching of the gastrocnemius muscle (autogenic inhibition). Five consecutive sessions will be held in the morning and afternoon in the laboratory of Sensory Motor Rehabilitation Engineering.
16128670|NCT01945138|Device|Closed Loop Insulin|The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms).
16128671|NCT01945125|Other|rhTSH Group|Patients receiving rhTSH for RIT stimulation
16128672|NCT01945112|Device|Paper Tape|Applied to blister prone areas of the foot
16128673|NCT01945099|Device|ePID closed loop system|Insulin pump controlled by closed loop unit and algorithm
16128674|NCT01945099|Drug|hyaluronidase|
16128675|NCT01945099|Drug|Lispro-PH20|
16128676|NCT01945086|Drug|Ustekinumab|Participants will receive subcutaneous (SC) injections of either ustekinumab 45 mg or ustekinumab 90 mg at Week 0 and Week 4.
16128677|NCT01945086|Drug|Placebo|Participants will receive SC injections of placebo at Week 0 and Week 4.
16128678|NCT01945086|Other|Concomitant topical medications for atopic dermatitis|Concomitant topical medications (as defined in the protocol) can be used from 4 weeks prior to randomization and throughout the study. However, the dosage cannot be increased and new medications cannot be added until after Week 12.
16128679|NCT01945073|Behavioral|Educational Booklet (BK)|The information booklet provides age appropriate explanation about SCD: inheritance patterns for the trait and common sickle cell disorders in the Jamaican population. It includes manifestations, complications and the necessary preventive and treatment advice. In addition, issues that are common to adolescents including sexual activity, contraceptive use, drug usage, career advice and developmental changes common to persons with the disease are also discussed.
16128808|NCT01943890|Device|Hypertonic saline|1 mmol/ml hypertonic saline given from (small children) 1,5 ml in 3 positions twice daily increasing to (children) 2 ml in 3 positions twice daily and up to (adults) 3 ml in 3 positions twice daily
16128809|NCT01943890|Procedure|Physiotherapy|
16128680|NCT01945073|Other|Formal Counselling (CB)|The study coordinator will have a face to face counselling session, lasting about 30 minutes, with the adolescent and/or caregiver. This will include the use of the educational booklet as an education tool, as well as a thorough discussion on the disease process; its manifestations, effects, and specific concerns during the adolescent period; as well as clarification of common myths and misconceptions about the disease.
16128681|NCT01945060|Device|heart rate Control to Range System (hrCTR) using DiAs Platform|"Diabetes Assistant (DiAs) Medical Platform System
~A smart-phone medical platform (DiAs);
~Continuous Glucose Monitor;
~Insulin pump;
~Bluetooth connection;
~Remote Monitoring Server."
16128682|NCT01945060|Other|DiAs Control-to-Range System not informed for heart rate|Not informing system of heart rate during exercise.
16128683|NCT01945047|Drug|Ketamine|Intravenous Bolus infusion Ketamine Hydrochloride 0.50 mg/mL over 40 minutes
16128684|NCT01945047|Drug|Midazolam|Bolus infusion of Midazolam Hydrochloride 1 mg/mL over 40 minutes
16128685|NCT01945034|Drug|Topical IBU twice daily|Topical gel administered as 4 inch strip twice daily for 7 days, and as needed for an additional 3 days
16128686|NCT01945034|Drug|Placebo twice daily|Topical gel administered as a 4 inch strip twice daily for 7 days, and as needed for an additional 3 days
16128687|NCT01945034|Drug|Topical IBU three times daily|Topical gel administered as a 4 inch strip three times daily for 7 days, and as needed for additional 3 days
16128688|NCT01945034|Drug|Placebo three times daily|Topical gel administered as a 4 inch strip three times daily for 7 days, and as needed for additional 3 days
16128689|NCT01945021|Drug|Crizotinib|
16128690|NCT01944995|Device|glasses broadband|
16128691|NCT01944995|Device|nasal CPAP|
16128692|NCT01944982|Biological|Expanded haploidentical natural killer cells (NKAEs)|
16128693|NCT01944969|Drug|Brexpiprazole|1, 2, or 3 mg/day, once daily dose, tablets, orally. Uptitration in weekly steps from 0.5 mg/day (patients ≥65) or 1 mg/day (patients 18-64 years)
16128694|NCT01944943|Drug|Vismodegib|150 mg (1 capsule) of Vismodegib per day orally in continue during 12 months
16128695|NCT01944930|Device|Laparoscopic narrow band imaging|
16128696|NCT01944930|Device|Standard white-light laparoscopy|
16128697|NCT01944904|Dietary Supplement|Sugar Pill|The placebo is identical in appearance to the XOS and contains 505mg maltodextrin
16128698|NCT01944904|Dietary Supplement|XOS 2.8|2.8g XOS is white or off-white crystalline substance and contains 500mg XOS 70P and 20mg maltodextrin
16128699|NCT01944865|Other|Interval Training|The interval training group consisted of 7 to 10 repetitions of 4-6 min at the highest intensity sustainable, the active recovery was 4-6 min in intensity from 10 to 15 of scale of perceived exertion CR100.
16128700|NCT01944865|Other|Intermittent Training|The riders of intermittent training group completed 8 to 12 repetitions of 30 s all-out with 4 min of active recovery.
16128701|NCT01944852|Drug|Icodextrin|
16128702|NCT01944839|Drug|E10030|
16128703|NCT01944839|Drug|ranibizumab|
16128704|NCT01944839|Drug|E10030 sham intravitreal injection|Pressure on the eye with a syringe with no needle
16128705|NCT01944826|Other|Registry of patients with Tako-Tsubo cardiomyopathy|
16128706|NCT01944813|Behavioral|ACp conversation|Intervention: Advance Care Planning conersation between a healtprofessionel and a patient about end-of-life discussions.
16128707|NCT01944800|Drug|Ticagrelor|Loading dose of 180 mg, followed by maintenance dose of 180 mg per day
16128708|NCT01944800|Drug|Prasugrel|Loading dose of 60 mg, followed by maintenance dose of 10 mg/day or 5 mg/day in patients =/> 75 years or < 60 kg
16128709|NCT01944787|Other|Routine|IV Hydration at 125 cc hour
16128710|NCT01944787|Other|IV Hydration at 250cc hour|IV Hydration at 250 cc hour
16128711|NCT01944774|Drug|Nemonoxacin 500 mg|IV Infusion, once daily for 7~14 days
16128712|NCT01944774|Drug|Nemonoxacin 650 mg|IV Infusion, once daily for 7~14 days
16128713|NCT01944774|Drug|Moxifloxacin 400 mg|IV Infusion, once daily for 7~14 days
16128714|NCT01944761|Behavioral|Exercise Program|Designed to improve cardio-respiratory fitness, the exercise program will be conducted for 12 weeks at a frequency of 3 sessions per week. Each exercise session will be conducted after school for a total duration of 90 minutes. First, training in a circuit of developmentally appropriate activities (30 minutes) will occur. Second, the training circuit will be followed by participation in an organized sport (i.e. 30 minutes of floor hockey, basketball, or indoor soccer). Following the workout sessions the children will receive a healthy snack and have an opportunity for socialization (30 minutes).
16128715|NCT01944748|Behavioral|Families Able To Resolve Situations (FARS)|Family mediation is a method of resolving conflicts between parents and teens. During the mediation session, the parent and teen each meet one-on-one with a trained volunteer mediator, who is a neutral person who listens to each party's concerns without taking sides. Then the parent and teen come together and meet with this mediator to work on resolving conflicts they are having. Families participate in up to 3 mediation sessions.
16128716|NCT01944735|Drug|CTX-4430|Ascending repeat doses of CTX-4430 will be administered orally, once-daily, to patients in 2 cohorts on days 1-15.
16128717|NCT01944735|Drug|Placebo|Repeat doses of placebo will be administered orally, once-daily, to patients in 2 cohorts on days 1-15
16128718|NCT01944722|Device|BD Onclarity™ HPV assay on BD Viper™ LT|The BD HPV specimen will be tested with the BD Onclarity™ HPV assay on the BD Viper™ LT instrument. The results will be compared to adjudicated histology. A portion of the specimens will be compared to a composite comparator generated by results of both Digene HPV and a polymerase chain reaction (PCR) sequencing test.
16128719|NCT01944722|Procedure|Colposcopy|Colposcopy will be performed on subjects that have abnormal cytology or HPV positive test results or random sampling of subject with normal cytology and HPV negative test results.
16128720|NCT01944709|Biological|Dendritic cell application|
16128721|NCT01944696|Other|phototherapy|Cycled versus continuous phototherapy during the first 2 wks after birth, both administered at bilirubin thresholds used in the NICHD Neonatal Network Phototherapy trial .
16128722|NCT01944683|Other|Placebo|
16128723|NCT01944683|Drug|GGF2|
16128724|NCT01944683|Drug|Midazolam|
16128725|NCT01944670|Device|Internal Joint Stabilizer - Elbow (IJS-E)|Device designed for internal stabilization of the elbow
16128810|NCT01943877|Procedure|scaling root planing|scaling root planing
16128726|NCT01944657|Device|Supplemental TMS|Supplemental TMS treatments will be administered utilizing the NeuroStar TMS Therapy® Machine. Treatment will be fixed at 120% of magnetic field intensity relative to the subject's resting motor threshold at a repetition rate of ten magnetic pulses per second, with a stimulus train duration (i.e., on time) of 4 seconds and an inter train interval (i.e., off time) of 26 seconds. The left dorsolateral prefrontal cortex will be the treatment location and this site will be determined by adjusting the TMS coil 5 cm anterior to the motor threshold location along a left superior oblique plane with a rotation point at about the tip of the patient's nose. Each treatment session will last approximately 37.5 minutes administering 3,000 magnetic pulses over the course of the treatment session.
16128727|NCT01944657|Drug|Standard Medication Monotherapy|These medications could include bupropion (Wellbutrin and others), citalopram (Celexa and others), Clomipramine (Ananfranil and others), duloxetine (Cymbalta), escitalopram (Lexapro and others), fluoxetine (Prozac and others), fluvoxamine (Luvox and others), imipramine (Tofranil and others), mirtazapine (Remeron and others), nortriptylatine (Pamelor, Aventyl, and others), paroxetine (Paxil, Pexeva, and others), phenelzine (Nardil), sertraline (Zoloft and others), tranylcypromine (Parnate and others), venlafaxine (Effexor and others).
16128728|NCT01944644|Device|Active Low Field Magnetic Stimulation|Active Low Field Magnetic Stimulation treatments will be delivered with a prototype LFMS device manufactured by Tal Medical. LFMS sessions consist of proton echo-planar magnetic resonance spectroscopic imaging (EP-MRSI) and will be 20min in duration. LFMS exposes subjects to magnetic fields of the same magnitude and frequency used in clinical MR-Spectroscopic imaging of the brain.
16128729|NCT01944644|Device|Sham Low Field Magnetic Stimulation|Sham Low Field Magnetic Stimulation will consist of a three-dimensional spoiled gradient echo sequence of the same duration as active LFMS and which provides auditory stimulation indistinguishable from active treatment.
16128730|NCT01944631|Device|Placebo|Nasal spray saline
16128731|NCT01944631|Device|Iota-Carrageenan|Nasal spray containing 1.20 g/l Iota-Carrageenan in saline
16128732|NCT01944618|Drug|Forxiga|FORXIGA is a prescription medicine used with diet, exercise and sometimes other medicines (which may include metformin; insulin; a sulfonylurea medicine such as gliclazide, glimepiride and glibenclamide; or a dipeptidyl peptidase-4 inhibitor [DPP 4 inhibitor] such as sitagliptin or saxagliptin) to control the levels of blood sugar (glucose) in patients with type 2 diabetes mellitus.
16128733|NCT01944592|Behavioral|Gynaecology Teaching Associates (GTA's)|Two GTA's will conduct the session according to the following structure; Students will receive a short anatomy PowerPoint presentation from the GTA's followed by demonstration of a gynaecological examination on a pelvic manikin. Students will then be taken to the out-patient department where one GTA will demonstrate pelvic examination on the other. Each student will then examine one of the GTAs under supervision by the other. The three non-active students will observe each of their colleagues' examinations. The students will then undergo a role play scenario where they will examine one of the GTAs under supervision of the other and feedback will be given by both GTAs.
16128734|NCT01944592|Behavioral|Manikin (conventional) training|Clinical Lecturers in Gynaecology (equivalent to Specialist Registrar experience) will conduct the sessions as follows: Students will receive a short anatomy PowerPoint presentation (the same as used in the GTA training). The Clinical Lecturer will then demonstrate pelvic examination on the pelvic manikin. Each student will then perform the pelvic examination twice supervised by the Clinical Lecturer.
16128735|NCT01944579|Other|Blackberries|Participants will receive blackberries as part of a controlled diet.
16128736|NCT01944579|Other|Control|Participants will receive a control food (jello) as part of a controlled diet.
16128737|NCT01944566|Biological|Microbial transplant|Every subject has 2 armpits; 1 armpit is treated, the other one is not treated. There is a microbial transplant from armpit bacteria.
16128738|NCT01944553|Device|The ROSA™ robot|"The ROSA™ robot can assist in identifying the pedicle entry point and in controlling the screw trajectory through a system of continuous monitoring of patient motion. This process strengthens the accuracy of pedicle screws implantation.
~Stabilisation in treatment for spine degenerative disease"
16128739|NCT01944540|Procedure|Optimized ESD with snaring|
16128740|NCT01944540|Procedure|Conventional ESD|
16128741|NCT01944501|Procedure|Transcranial Magnetic Stimulation|TMS over the left temporoparietal cortex
16128742|NCT01944501|Procedure|Transcranial Direct Current Stimulation|TDCS over the left temporoparietal cortex
16128743|NCT01944488|Drug|GnRH agonist|100 µg/m2 body surface max 100 µg i.v.
16128744|NCT01944462|Behavioral|Pharmacist Pneumococcal Vaccine Program (PPVP)|1.5 hour educational intervention delivered onsite at collaborating senior center consisting of 3 components: presentation about pneumococcal disease and the vaccine given by a infectious disease-certified pharmacist; 2) skits given by volunteer actors at the senior center to illustrate real world scenarios related to pneumococcal disease and the vaccine; 3) action planning to consist of small group breakouts led by licensed pharmacists and 4) vaccination day which is an optional component following the education program, for participants eligible to receive the vaccine. Vaccination to be provided free of charge to eligible participants who opt to receive it.
16128745|NCT01944449|Dietary Supplement|Whey Protein (WPC) at breakfast|The type 2 diabetic subjects in Whey Protein (WPC) group will consume at breakfast WPC (35 g) in 250ml of milk, Total 42 g protein breakfast for 12 weeks.
16128746|NCT01944449|Dietary Supplement|Other Protein Sources at breakfast|The type 2 diabetic subjects in PBdiet will consume also 42 g of protein but from different sources : i.e soy,tuna, eggs, at breakfast in bottle mixed with 250 ml water twice a day (30 min before breakfast and before dinner) for 12 weeks.
16128747|NCT01944449|Dietary Supplement|Low Protein at breakfast|The type 2 diabetic subjects in CBdiet group will consume only 17 g protein, namely from at breakfast for 12 weeks.
16128748|NCT01944436|Drug|Cholinesterase Inhibitors (Rivastigmine, Aricept, Galantamine)|
16128749|NCT01944423|Drug|d-cycloserine|d-cycloserine is a medication thought to be associated with fear extinction.
16128750|NCT01944423|Drug|Pill Placebo|
16128803|NCT01943955|Behavioral|home-based computer gaming|A computer mouse mounted to a headband and placed on the participant's head is used to interact with the game cursor. In order to interact with/play the game the participant must visually focus on the moving target and perform unpredictable head movements. Balance exercises are incorporated progressively and simultaneously during computer gaming.
16128804|NCT01943942|Drug|Montelukast 10 mg|Reference product
16128751|NCT01944423|Drug|Nicotine replacement therapy|All participants will receive Nicoderm CQ®, 24-hour transdermal nicotine patches and will be educated about the use of the patch at the session immediately prior to quit date. They will be instructed to apply one patch daily, beginning on quit date (week 5). Participants will use the 3-step tapering Nicoderm process (21-mg, 14-mg, and 7-mg). This regimen has been used in previous trials with a similar formulation of the patch (Fiore, 2000). A meta-analysis found no differences in outcome between 16- or 24-hour patches (Fiore et al., 1994). Participants who continue to smoke or lapse after quit day will not be instructed to discontinue the patch until their smoking level reaches 4 cigarettes/day for 4 days. Smokers who lapse during treatment will be encouraged to set a new quit date and continue their cessation attempt.
16128752|NCT01944423|Behavioral|Panic and Smoking Reduction Treatment|PSRT incorporates elements of standard smoking cessation treatment (i.e., counseling plus NRT) with procedures for reducing panic and enhancing tolerance to withdrawal sensations. Written therapist and patient manuals will be used and followed at all times to ensure standardized delivery of the treatment. Interventions that uniquely focus on addressing panic, fears and intolerance of anxiety, bodily-related sensations, and affect-relevant withdrawal symptoms include: (1) interoceptive exposure; (2) corrective information about anxiety and cognitive interventions designed to teach patients alternatives to catastrophic misinterpretations of the sensations and their feared consequences; and (3) situational exposure.
16128753|NCT01944410|Biological|PRP injection|injection of PRP to traumatic bone cyst defect
16128754|NCT01944384|Drug|aldactone|aldactone 25 mg for 6 months
16128755|NCT01944371|Drug|Disulfiram|This study will provide open label disulfiram. Subjects will take 1 dose of disulfiram per day for 3 days.
16128756|NCT01944332|Procedure|gamete treatment|Patient specimen will be selected through a synthetic, sterile, single-use, culture-tested mesh. The specimen will then be placed in a 37°C environment. After 30 minutes, the selected portion is retrieved from the other side of the mesh. The spermatozoa will be prepared in the standard fashion and utilized for injection or intrauterine insemination after exposure to a membrane permeabilizing agent. The injected oocytes will then be exposed to activating agents for the purpose of inducing embryo development. The oocyte activating agent is calcium ionophore and for sperm membrane permeabilization to assist in sperm DNA decondensation is streptolysin O (SLO).
16128757|NCT01944319|Drug|Routine meropenem therapy|Participants in control group will accept meropenem therapy with regimen routinely decided by attending physician
16128758|NCT01944319|Drug|Meropenem therapy based on a PPK and PD model|Participants in study group will accept meropenem therapy based on a software developed from a PPK and PD model
16128759|NCT01944293|Drug|Ketamine|Single dose of 0.5 mg/kg of Ketamine given intravenously (in the vein) over 40 minutes
16128760|NCT01944293|Drug|Midazolam|Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes
16128761|NCT01944280|Other|massage|
16128762|NCT01944267|Procedure|Apically positioned flap|"Standard TUSDM Periodontology Clinic procedures will be followed. Local anesthesia will be achieved. Center of implant fixtures will be located. Crestal incision thru the center of implant fixture will be made. Implant fixture will be uncovered and healing abutment/s will be inserted. Horizontal incision at approximately 0.5mm coronal to buccalmucogingival junction will be made 1 tooth mesial to 1 tooth distal to the treating area.
~No vertical incision will be made Gingiva coronal to horizontal incision will remain intact Partial thickness flap will be prepared and displaced apically approximately 7mm from the horizontal incision and secured with sutures.
~Prepared surgical area will be measured apico-coronally and mesio-distally."
16128763|NCT01944267|Procedure|Free Gingival Graft|"Standard Clinic procedures followed. Local anesthesia achieved. Center of implant fixtures located. Crestal incision thru center of fixture will be made.
~Implant fixture uncovered and healing abutment/s inserted. Horizontal incision at approx 0.5mm coronal to buccalmucogingival junction will be made 1 tooth mesial to 1 tooth distal to the treating area.
~No vertical incision made. Gingiva coronal to horizontal incision remains intact.
~Partial thickness flap prepared and displaced apically approximately 7mm from horizontal incision; secured with sutures. Prepared recipient bed measured apico-coronally and mesio-distally. Masticatory mucosa from palate of treating side (Right or Left) harvested according to size measured from recipient bed with width of approximately 5mm at line of measurement. Harvested graft material will be transplanted on recipient bed, lined with initial horizontal incision line with sutures"
16128764|NCT01944267|Procedure|apically positioned flap with Mucograft|"Standard TUSDM Periodontology Clinic procedures followed. Local anesthesia achieved.
~Center of implant fixtures will be located. Crestal incision thru the center of implant fixture will be made. Implant fixture will be uncovered and healing abutment/s will be inserted. Horizontal incision at approximately 0.5mm coronal to buccalmucogingival junction will be made 1 tooth mesial to 1 tooth distal to the treating area.
~No vertical incision will be made. Gingiva coronal to horizontal incision will remain intact. Partial thickness flap will be prepared and displaced apically approximately 7mm from the horizontal incision and secured with sutures.
~Prepared recipient bed will be measured apico-coronally and mesio-distally. Mucograft material will be prepared according to the manufacturer's instruction and trimmed as the size measured from the recipient and be placed and secured on the recipient bed with sutures."
16128765|NCT01944254|Procedure|Cardiac output measurement at random to respiration|Cardiac output measurement obtained by pulmonary artery catheter thermodilution technique (PAC TD)
16128766|NCT01944254|Procedure|Cardiac output measurement synchronised at start of expiration|Cardiac output measurement obtained by PAC TD
16128767|NCT01944254|Procedure|Cardiac output measurement timed to instructed exhalation|Cardiac output measurement obtained by PAC TD
16128768|NCT01944228|Device|Vagal Nerve Stimulation|30 minutes of vagal nerve stimulation using a catheter in the IJV
16128769|NCT01944228|Device|Sham Stimulation|Catheter placed in the IJV without stimulation
16128770|NCT01944215|Dietary Supplement|Meal|effect of meal
16128771|NCT01944215|Other|Exercise|effect of exercise
16128772|NCT01944215|Radiation|Sestamibi|reduce radiation dose
16128773|NCT01944215|Drug|Caffeine Tablet|effect of caffeine
16128774|NCT01944215|Other|External Heating|Heating Pad and warm blanket robe
16128775|NCT01944202|Behavioral|Educational intervention|Educational and feedback intervention, as described in the Arm Description.
16128805|NCT01943942|Drug|Montelukast 10 mg|Test product
16128806|NCT01943916|Device|Imagio OA/US (US and OA/US)|opto-acoustic plus gray scale ultrasound
16128776|NCT01944189|Dietary Supplement|Food|"Nested comparative bioavailability study: 48 out of 70 children randomized to 2 food arms under 2 dose groups of artemether lumefantrine (20mg /120 mg) treatment according to standard care weight based dose groups (> 5 to >15 kg receive 1 tablet and 15 to > 25 kg receive 2 tablets)
~Food arms:
~Standard arm = Milk
~Experimental arm = maize porridge plus oil
~Groups include Single dose group= 1 tablet of artemether lumefantrine (20/120 mg) and Double dose group= 2 tablet of artemether lumefantrine (20/120 mg)
~Standard arm children receiving milk and single dose(12) Standard arm children receiving milk and double dose(12) Experimental arm children receiving maize porridge plus oil and single dose(12) Experimental arm children receiving maize porridge plus oil and double dose (12)"
16128777|NCT01944176|Drug|simvastatin, placebo|
16128778|NCT01944163|Other|Applying a referral model|GP are randomized in clusters either to use or not to use the CaFaSpA referral model. The CaFaSpA referral models consists out of four variables, a positive ASAS IBP questionnaire, a positive family history for SpA, a good reaction to NSAIDs and back pain duration longer than 5 years. If at least two out of four variables are present a referral to the rheumatologist is advised.
16128779|NCT01944150|Behavioral|Transcutaneous electrical nerve stimulation|explanations about devices and their use are given to the patient during the first session. The right place where the electrodes should be placed on, the most effective programme (optimal electric frequency provided by the machine), intensity are tested by the nurse during 30 minutes lasting session
16128780|NCT01944150|Behavioral|Transcutaneous electrical nerve stimulation and hypnosis|explanations about devices and their use are given to the patient during the first session. The right place where the electrodes should be placed on, the most effective programme (optimal electric frequency provided by the machine), intensity are tested by the nurse. Following informations are collected by the second nurse: pain representation and its relief thoughts about a quiet place. TENS and hypnosis are associated in a unique 30 minutes session
16128781|NCT01944137|Other|Nursing Intervention|Participants will receive 4 planned phone calls from nurse practitioners during their first 2 cycles of chemotherapy, in order to proactively monitor and address chemotherapy-related symptoms.
16128782|NCT01944124|Behavioral|Mobile Health|Participants monitored their blood pressure 3x per week, blood glucose 1x per week, pedometer steps daily and body weight monthly. Measures from devices were transferred or inputted to a smartphone data portal. Planned exercise was logged electronically on the smartphone.
16128783|NCT01944124|Behavioral|Exercise Prescription|An exercise program was prescribed tailored to participant fitness level (using the Step Test Exercise Prescription (STEP-TM) protocol). Briefly, STEP-TM required participants to step up and down a set of 2 steps 20 times at a comfortable pace. A predictive equation including post-test heart rate, time to complete test, age, body weight and sex was used to calculate fitness. An exercise program was prescribed including aerobic exercise most days of the week for 30-60 minutes in duration at a target heart rate tailored to fitness level. Light resistance training was also prescribed 2-4 times per week.
16128784|NCT01944111|Device|Plication|Prospective clincial trial comparing adjustable gastric banding with plication versus standard adjustable gastric banding. Variables to be studied include patient age, gender, ethnicity, co-morbid disease conditions, height, weight, BMI, intra-operative data such as operative time and blood loss and post-operative outcomes including length of hosptial stay, complication rates, weight loss, and co-morbid disease resolution.
16128785|NCT01944098|Drug|Lidocaine|
16128786|NCT01944098|Drug|Placebo|
16128787|NCT01944085|Drug|Acetaminophen|Syrup
16128788|NCT01944085|Drug|Ibuprofen|Syrup
16128789|NCT01944085|Other|Vitamin C|Syrup
16128790|NCT01944072|Other|Aerobic exercise training intensity|
16128791|NCT01944059|Drug|Theramine (medical food/old drug)|Theramine® is a prescription medical food that is composed of variety of amino acids and/or their precursors.
16128792|NCT01944059|Other|Placebo (l-alanine)|Theramine like placebo comparator
16128793|NCT01944046|Drug|Double blind phase Placebo Nasal Spray|This nasal spray will contain all of the ingredients that are in the active oxytocin spray in the same quantities, except oxytocin will NOT be added to the solution. It will be packaged using the same container system as the active oxytocin nasal spray. Each bottle's label will have its own unique nonsequential randomly assigned number and not a lot number to facilitate masking. Dose titration will occur using exactly the same criteria and procedures as for active study drug.
16128794|NCT01944046|Drug|double Blind Oxytocin Nasal Spray|Each insufflation will deliver 8 IU or 24 IU of oxytocin. A maximum of 3 insufflations at a time will be required. Dosing will be flexible between 8 IU/day and 80 IU/day, typically in two divided doses delivered in the morning and in the afternoon. Doses will typically increase by 8 IU twice daily (BID) at week 2 and weeks 4 and 8 until achieving the target dose of 24 IU BID at week 8. Subsequently doses may be increased in 8 IU BID increments ONLY at each visit until a maximum dose of 40 IU BID is achieved.Each bottle's label will have its own unique nonsequential randomly assigned number and not a lot number to facilitate masking. During the open label phase after approximately March 2019 the study used only the 24 IU /0.10 ml formulation and the maximum dose was 72 IU per day.
16128795|NCT01944046|Drug|Open Label intranasal oxytocin|All participants who completed the 24 week double blind phase were eligible to join a 24 week open label phase in which all participants received intranasal oxytocin
16128796|NCT01944033|Drug|Bricanyl/Iprovent|5 mg Terbutaline sulfate (2ml) + 0,5 mg Ipratropium bromide (2ml) + 1ml serum saline in each nebulization which is repeated three times during 1 hour and every 4 hours during the first 24 hour protocol
16128797|NCT01944033|Drug|Bricanyl|5 mg Terbutaline sulfate (2ml) + 3ml serum saline in each nebulization which is repeated three times during 1 hour and every 4 hours during the first 24 hour protocol
16128798|NCT01944020|Device|CPAP|use of CPAP each night for 2 months
16128799|NCT01944007|Drug|Cross-Linked Polyelectrolyte (CLP)|CLP was administered orally, in capsules, for 9 consecutive days.
16128800|NCT01943994|Drug|Psilocybin-assisted treatment|Participants will be administered 30 mg/70 kg psilocybin. Preliminary evidence from our ongoing psilocybin dose-effects study suggests that this dose is associated with mystical-type experiences.
16128801|NCT01943994|Drug|Nicotine Replacement Therapy (NRT)|
16128802|NCT01943968|Other|Blood test|
16128807|NCT01943916|Device|Imagio gray scale ultrasound|gray scale ultrasound alone
16128811|NCT01943877|Drug|Propolis|experimental
16128812|NCT01943864|Drug|Trametinib (single tablet)|The drug substance is blended with inert
16128814|NCT01943851|Drug|GSK525762|GSK525762 1 mg, 10 mg and 30 mg will be supplied as white to off-white, amorphous free base and white to slightly colored crystalline besylate tablets, round, biconvex tablets with no markings. GSK525762 will be administered with 240 milliliter (mL) water.
16128815|NCT01943838|Drug|SAR245408|Pharmaceutical form: tablet Route of administration: oral
16128816|NCT01943825|Biological|CYD Dengue Vaccine|0.5 mL, Subcutaneous
16128817|NCT01943825|Biological|CYD Dengue Vaccine|0.5 mL, Subcutaneous
16128818|NCT01943825|Biological|Japanese Encephalitis Vaccine|0.5 mL, Intramuscular
16128819|NCT01943825|Biological|Japanese Encephalitis Vaccine|0.5 mL, Intramuscular
16128820|NCT01943812|Drug|Estradiol and progeterone|Estradiol and progesterone
16128821|NCT01943799|Biological|GS-4774|Administered as a subcutaneous injection every 4 weeks for a total of 6 doses
16128822|NCT01943799|Drug|OAV Regimen|Administered prior to study enrollment (tenofovir disoproxil fumarate, entecavir, adefovir, lamivudine, or telbivudine either as single agents or in combination)
16128823|NCT01943786|Drug|FOLFIRI + Cetuximab|Patients will receive study treatment (FOLFIRI + Cetuximab) according to regular clinical practice
16128824|NCT01943773|Procedure|Functional Assessment|"Both arms of the study will undergo functional assessments at three points during the study progress.
~BASELINE ASSESSMENT: On study entry, each participant will have a timed up-and-go, Mini Mental Status Exam, de Morton, Modified Physical Performance Test (MPPT), and a short physical performance battery performed.
~ASSESSMENT OF INTERVENTION EFFECTIVENESS:
~Immediately prior to the operation, all participants will undergo repeat testing. The difference in scores between the preoperative assessment and the initial assessment at enrollment will be compared in the control and intervention groups.
~POST-OPERATIVE ASSESSMENT: Repeat testing will be performed 60 days following the operation."
16128825|NCT01943773|Procedure|Prehabilitation|The intervention will consist of nine 45 minute long physical therapy sessions.
16128826|NCT01943760|Drug|tramadol|The volume of the solution was adequate to maintain the concentration of 2% tramadol
16128827|NCT01943760|Drug|0.9% saline|
16128828|NCT01943734|Behavioral|Information passed on anthropometric assessment|Information passed on worker's anthropometric assessment.
16128829|NCT01943721|Drug|VISION5 Product|
16128830|NCT01943708|Device|SPAP|Novel Auto-algorithm for Auto-CPAP device
16128831|NCT01943708|Device|CPAP|Standard CPAP therapy
16128832|NCT01943695|Behavioral|Aerobic Training|
16128833|NCT01943695|Behavioral|Educational Information|Subjects will be given material regarding cancer and it's impact.
16128834|NCT01943695|Behavioral|Supervised Home Based Training|Patients that elect supervised home based training platform or plan to complete unsupervised training sessions will receive a study kit which includes a heart rate monitor, blood pressure cuff, treadmill and tablet to complete aerobic training requirements. The study kit will be given to the patient upon completion of their baseline testing. The treadmill will be shipped to the patient's home and coordinated by the Ex Onc group. The treadmills are MSK owned equipment that will be deployed to the patient's homes via the vendor TechnoGym. A member of Ex Onc will provide an orientation session for the patient to set up all study kit items. If there is a delay in the patient receiving the treadmill , or any other unforeseen circumstance, patients may be assigned a temporary unsupervised training program until the treadmill is delivered.
16128835|NCT01943682|Drug|CPX-351|Comparison of Different doses of drug
16128836|NCT01943669|Device|ReWalk™ device|Twenty one-hour ReWalk™ training sessions are scheduled for each participant over a 10-week period.
16128837|NCT01943656|Device|Tobii™ Eyegaze System|Volunteers will be instructed and trained to use the Tobii™ Eyegaze System. The number of sessions required to successfully master the device depends on the learning curve of the patient. The progress will be documented accordingly. After successful completion of the training and supervised use, the inpatients will be offered the Tobii™ Eyegaze System for unsupervised use, 4 hours a week, for the following 2 months.
16128838|NCT01943643|Procedure|multislice CT angiography|Study patients will undergo MSCTA on Toshiba Aquilion CXL 128 slice CT scanner using predefined protocol. The procedure will include calcium scoring (Agatston) then CT angiography using Ultravist 370 contrast agent ((iopromide concentration 370 mg/ml, Bayer Health Care, Germany). MSCTA angiograms will be analyzed using dedicated software Vital Vitrea Advanced 6.2, Vital Images, Minnetonka, Minnesota, US. The bifurcation lesion analyses will include: the measurement of the angle between MB and SB, measurement of the lesion length, reference diameter of the vessel, degree of stenosis, atherosclerotic plaque analysis 10 mm proximal and distal in the MB, and 5 mm from the ostium of the SB, and at the level of maximum stenosis (minimal lumen diameter).
16128839|NCT01943630|Drug|15% AS101 gel|Administration of Topical 15% AS101 once a day (overnight)
16128840|NCT01943630|Drug|Vehicle|Administration of Vehicle once a day (overnight)
16128841|NCT01943617|Drug|Entecavir|anti-viral therapy
16128842|NCT01943617|Drug|Thymosin-α|anti-viral and antitherapy
16128843|NCT01943604|Other|Nutella Breakfast|Breakfast composed of bread and Nutella, milk and apple slices
16128844|NCT01943604|Other|Waffle Breakfast|Breakfast composed of waffles and syrup, milk, and apple slices
16128845|NCT01943591|Device|Endovascular coiling with standard 10-caliber platinum coils or 15-caliber platinum coils|Embolization using 15-caliber platinum coils or standard 10-caliber platinum coils.
16128846|NCT01943565|Drug|Hydromorphone 25mcg|Intrathecal Hydromorphone 25mcg
16128847|NCT01943565|Drug|Hydromorphone 50mcg|Intrathecal Hydromorphone 50mcg
16128848|NCT01943565|Drug|Hydromorphone 100mcg|Intrathecal Hydromorphone 100mcg
16128849|NCT01943565|Drug|spinal anesthesia|bupivacaine 0.75% 1.6 mL (12mg)
16128850|NCT01943552|Drug|placebo|normal saline
16128851|NCT01943552|Drug|ipratropium bromide|ipratropium bromide
16128852|NCT01943539|Device|Neuro-typical controls and ADHD will receive EVO game play.|EVO mobile video application
16128853|NCT01943526|Biological|natalizumab|Natalizumab will not be provided as a part of this study. Participants will receive natalizumab as prescribed by their treating physician.
16128854|NCT01943513|Biological|BIIB023|Intravenous (IV) infusions
16128855|NCT01943513|Biological|Placebo|Matched placebo
16128856|NCT01943487|Drug|EC905|Oral
16128857|NCT01943487|Drug|verapamil|Oral
16129007|NCT01942161|Drug|Aripiprazole Low (2 mg/day)|administered 2 mg once daily for 6 weeks
16128858|NCT01943474|Device|AccuCath IV Catheter Device|Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.
16128859|NCT01943474|Device|Conventional IV Catheter Device|Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples.
16128860|NCT01943461|Drug|Avelumab 3 mg/kg|Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 3 milligrams per kilogram (mg/kg) once every 2 weeks in the dose- escalation cohort until disease progression, unacceptable toxicity or withdrawal from the study or study drug occurred.
16128861|NCT01943461|Drug|Avelumab 10 mg/kg|Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 10 mg/kg once every 2 weeks in the dose- escalation cohort and expansion cohort until disease progression, unacceptable toxicity or withdrawal from the study or study drug occurred.
16128862|NCT01943461|Drug|Avelumab 20 mg/kg|Participants received intravenous infusion of Avelumab over 1 hour duration at a dose of 20 mg/kg once every 2 weeks in the dose- escalation cohort until disease progression, unacceptable toxicity or withdrawal from the study or study drug occurred.
16128863|NCT01943435|Drug|NSAIDs; adjunctive analgesics; adjunctive anti-depressants|Physician will administer these medications based upon the individual needs of each patient.
16128864|NCT01943435|Procedure|Lumbar epidural injection|The attending physician may refer subjects for epidural injections at a pain clinic that is affiliated with the University of Pittsburgh Medical Center. All epidural injections will be provided by licensed physicians who are board certified in physical medicine and rehabilitation or anesthesiology.
16128865|NCT01943435|Other|Joint Mobilizations (spine, sacroiliac, hip)|These joint mobilizations will be applied manually to the lumbar facet joints, sacroiliac joints, and/or hip joints by licensed physical therapists and chiropractors.
16128866|NCT01943435|Other|Individualized exercises: clinical setting|The treating physical therapist or chiropractor will work with each subject to develop a set of individualized exercises in the clinic setting. The goal is to have the subjects continue these exercises at home.
16128867|NCT01943435|Other|Group Exercise: community setting|The group exercise will take place at community centers that provide exercise classes for older adult. The exercises are taught by certified fitness instructors in a group setting at these community centers.
16128868|NCT01943422|Drug|High-dose Interferon alfa-2b|•Vemurafenib at standard dosing with a 2 week lead-in period to identify potential effects. IFNα-2b following this (week 2 onwards) at standard induction (4 weeks) and maintenance (48 weeks) doses.
16128869|NCT01943422|Drug|Vemurafenib|"Vemurafenib is a prescription medicine used to treat melanoma, that has spread to other parts of the body or cannot be removed by surgery, and that has a certain type of abnormal BRAF gene."
16128870|NCT01943409|Drug|Intralipid|soybean oil-based lipid emulsion
16128871|NCT01943409|Drug|ClinOleic|olive oil-based lipid emulsion
16128872|NCT01943396|Procedure|rheohemapheresis|Each treated patient will receive a series of 8 rheohemaphereses (cascade filtration) within 10 weeks. One plasma volume will be washed.
16128873|NCT01943383|Genetic|iPSC|Single blood draw for the production of induced pluripotent stem cells.
16128874|NCT01943370|Other|Early saline irrigation|Initiation of post-operative saline irrigation earlier during the post-operative course
16128875|NCT01943370|Other|Routine Irrigation|Routine initiation of saline irrigation
16128876|NCT01943357|Behavioral|Diabetes Self Management Program|The interventions include modeling and action-planning to enhance self-efficacy.
16128877|NCT01943344|Device|VIVASURE CLOSURE DEVICE™|implantation of VIVASURE CLOSURE DEVICE™
16128878|NCT01943318|Procedure|Liver biopsy|Histologic evaluation
16128879|NCT01943318|Device|Hepatic venous pressure gradient (HVPG) measurement|Hepatic venous pressure gradient (HVPG) measurement
16128880|NCT01943305|Biological|Japanese Encephalitis vaccine|IXIARO, inactivated, adsorbed vaccine. Two doses (0.5 ml each) of IXIARO one month apart
16128881|NCT01943305|Biological|Yellow Fever vaccine|STAMARIL, 1 dose (0.5 ml)
16128882|NCT01943292|Drug|Defactinib|
16128883|NCT01943279|Other|Remote Follow-up (RFU)|Women in the RFU group will be asked to return to the clinic for assessment if they have any complications.
16128884|NCT01943279|Other|Standard Follow-up (SFU)|Study Day 15 (± 3 days)requires an in-person post-abortion checkup: transvaginal ultrasound, and a bimanual exam to confirm successful pregnancy expulsion.
16128885|NCT01943266|Dietary Supplement|protein intake|on the study day, the diet will be provided as free amino acids,with calories made up by a liquid diet and protein free cookies. Protein intake will be varied at 0.2, 0.5, 0.7, 0.9, 1.0, 1.2, 1.5, 1.8, and 2.0 g.kg/day
16128886|NCT01943253|Device|Conventional ESD|Conventional ESD: Conventional ESD technique using IT2-Knife, Dual-Knife, Hook-Knife (Olympus Europe, Hamburg, Germany; Olympus Japan) ERBE VIO 300D (V2.1.4) RF-surgery system (ERBE Elektromedizin GmbH, Tübingen, Germany) Injection of fluid: Syringe
16128887|NCT01943253|Device|Hybridknife ESD|Group 2: Water-jet assisted HybridKnife® ESD technique using HybridKnife® (Erbe Elektromedizin GmbH, Tübingen, Germany) ERBE VIO 300D (V2.1.4) RF-surgery system (ERBE Elektromedizin GmbH, Tübingen, Germany) Injection of fluid: Integrated in HybridKnife® with ERBEJet 2 water-jet surgery system (ERBE Elektromedizin GmbH, Tübingen, Germany)
16128888|NCT01943240|Drug|Paravertebral nerve block: 4 mL ropivacaine 0.5% at each of six levels|
16128889|NCT01943240|Drug|10 cc of 0.375% ropivacaine pectoral nerve block|
16128890|NCT01943227|Other|controlled positive pressure ventilation 9ml/kg tidal volume|controlled positive pressure ventilation 9ml/kg tidal volume
16128891|NCT01943227|Other|controlled positive pressure ventilation 6ml/kg tidal volume|controlled positive pressure ventilation 6ml/kg tidal volume
16128892|NCT01943201|Device|new bedsheet|sleeping 5 nights on the new bedsheet
16128893|NCT01943201|Device|conventional bedsheet|sleeping 5 nights on the conventional bedsheet
16128894|NCT01943188|Radiation|stereotactic body radiation therapy|Undergo SBRT
16128895|NCT01943188|Drug|cyclophosphamide|Given PO
16128896|NCT01943188|Biological|therapeutic autologous lymphocytes|Undergo autologous PBMC infusion
16128897|NCT01943188|Other|laboratory biomarker analysis|Correlative studies
16128898|NCT01943162|Behavioral|CPT|
16128899|NCT01943136|Drug|papaya 1% extract ointment|
16128900|NCT01943136|Drug|mupirocin 2% ointment|
16129267|NCT01940263|Dietary Supplement|Placebo|
16128901|NCT01943123|Dietary Supplement|probiotic drink|comparison of study group (probiotic group) with the control group regarding the number of CFU of microbes in oral cavity and the overall oral health status measured using indices
16128902|NCT01943123|Dietary Supplement|Placebo Comparator: plain, unsweetend, unflavored pasturised milk|comparison of control group with the study group (probiotic group) regarding the number of CFU of microbes in oral cavity and the overall oral health status measured using indices
16128903|NCT01943110|Device|ID adapter (autodisable)|Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin. Contains an autodisable feature to prevent reuse.
16128904|NCT01943110|Device|ID adapter (side load)|Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin.
16128905|NCT01943084|Drug|Norditropin® FlexPro® pen|Administered as a single subcutaneous (s.c., under the skin) dose (4.0 mg) on 2 separate dosing visits (treatment periods). The 2 treatment periods will be separated by a 7-day washout period.
16128906|NCT01943084|Drug|Genotropin Pen®|Administered as a single subcutaneous dose (4.0 mg) on 2 separate dosing visits (treatment periods). The 2 treatment periods will be separated by a 7-day washout period.
16128907|NCT01943071|Behavioral|Day care for patients with dementia|Day care centres designed by the local authorities for patients with dementia
16128908|NCT01943058|Drug|megestrol acetate|Given PO
16128909|NCT01943058|Device|levonorgestrel-releasing intrauterine system|Given IUD
16128910|NCT01943058|Other|laboratory biomarker analysis|Correlative studies
16128911|NCT01943058|Other|questionnaire administration|Ancillary studies
16128912|NCT01943045|Biological|NGM282|
16128913|NCT01943045|Other|Placebo|
16128914|NCT01943019|Drug|Linagliptin|
16128915|NCT01943006|Drug|Hirudoid cream 0.3 % Mucopolysaccharide polysulfate|Hirudoid cream
16128916|NCT01943006|Drug|Placebo cream without active substance|
16128917|NCT01942993|Drug|Vemurafenib|Vemurafenib will be administered at the FDA approved dose of 960 mg approximately 12 hours apart with or without a meal. Vemurafenib is provided at 240-mg film-coated tablets packed in bottles for oral administration. Vemurafenib should be swallowed whole with a glass of water and the medication should not be chewed or crushed. Management of symptomatic adverse events may require dose reductions, treatment interruptions, or treatment discontinuation. Dose reductions below 480 mg twice daily are not recommended.
16128918|NCT01942980|Radiation|Radiation therapy Brain metastasis in breast cancer|Radiation
16128919|NCT01942967|Other|Echocardiography|"Measurement of:
~Left ventricular output (LVO).
~Right ventricular output (RVO).
~Assessment of the Mesenteric Artery Flow."
16128920|NCT01942967|Other|Near Infrared Spectroscopy Monitoring|Measurement of cerebral and mesenteric regional oxygen saturation(rSO2) trends and data while the baby on CPAP or TrPA modes of noninvasive ventilation.
16128921|NCT01942954|Other|Mobile health cognitive stimulation|
16128922|NCT01942941|Device|geko™ electrical stimulation|applied to stimulate peroneal nerve and cause active muscle twitch
16128923|NCT01942928|Other|Usual NHS Care|Usual NHS care is provided by a health visitor who will diagnose excessively crying infants/infants with colic in the first instance. Parents usually will then have the opportunity to consult their health visitor when needed. The health visitor will provide support and advice on how to manage the condition within their professional remit.
16128924|NCT01942928|Other|Osteopathic Manipulative Therapy|Osteopathic treatment will be provided by experienced osteopaths once a week for up to four weeks, depending on needs. Treatment will be individualised, according to clinical findings, and involves using standard cranial osteopathic techniques. All parents will be able to ask questions.
16128925|NCT01942915|Biological|Umbilical Cord Blood Mononuclear Cells|Participants will be transplanted with umbilical cord blood mononuclear cells.
16128926|NCT01942902|Device|Continuous Glucose Monitoring System|
16128927|NCT01942889|Dietary Supplement|Antioxidant Supplementation associated to Comprehensive respiratory Rehabilitation Program|Vit E, Vit C, Selenomethionine, Zinc gluconate
16128928|NCT01942876|Behavioral|Quit Using Drugs Intervention Trial|The goal of the Quit Using Drugs Intervention Trial (QUIT) is to conduct a small RCT of a primary care clinic-based very brief intervention protocol for reducing the use of illegal drugs and the occurrences of drug-related harm in low-income, racially-diverse patient populations at two 'safety-net' clinics in Los Angeles. The design will emphasize screening, very brief clinician advice, and telephone drug-use health education to reduce 'at risk' drug use and thus interrupt progression from casual or episodic abuse to dependence.
16128929|NCT01942876|Behavioral|Health behavior maintenance|This attention-control arm will receive a sham telephone intervention of equivalent duration on health behavior maintenance.
16128930|NCT01942863|Procedure|water exchange single balloon enteroscopy|Oral enteroscopy was performed first, followed by the anal route on the same day or later. For oral route, SBE was first advanced beyond Treitz ligation with CO2 insufflation. Then the water exchange method was used for further insertion. Briefly, residual air in the lumen was suctioned, and 37°C water was infused with a peristaltic pump through the biopsy channel to obtain lumen visualization. Turbid luminal water due to residual feces was suctioned and replaced by clean water until the small bowel lumen was clearly visualized again. Thus, infused water was removed predominantly during the insertion phase. The total volume of water was not restricted. For anal route, water exchange or CO2 insufflation method was used from the beginning of insertion respectively.
16128931|NCT01942863|Procedure|CO2 insufflation single balloon enteroscopy|Conventional enteroscopy was performed as CO2 insufflated during insertion. Oral enteroscopy was performed first, followed by the anal route on the same day or later.
16128932|NCT01942863|Other|Procedural Requirements|SBE was advanced as deeply as possible and complete small bowel visualization was attempted. When the following conditions were met, tattooing at the deepest position with India ink was performed and the endoscope was withdrawn: no further endoscopic advancement could be achieved, detection of a significant lesion and no other lesions suspected, severe stricture, obvious sedation and SBE-related adverse events happened which required termination of further intubation.
16128933|NCT01942837|Drug|Enzalutamide|"Administration: 160 mg orally once daily. Treatment will be continued until evidence of symptomatic or radiographic progression or the participant is taken off the study for another reason.
~Dosing: 160 mg orally taken once daily as four 40 mg capsules."
16128934|NCT01942824|Behavioral|Text Messages|
16128935|NCT01942811|Behavioral|Quit Using Drugs Intervention Trial|The goal of the Quit Using Drugs Intervention Trial (QUIT) is to conduct a small RCT of a primary care clinic-based very brief intervention protocol for reducing the use of illegal drugs and the occurrences of drug-related harm in low-income, racially-diverse patient populations at two 'safety-net' clinics in Los Angeles. The design will emphasize screening, very brief clinician advice, and telephone drug-use health education to reduce 'at risk' drug use and thus interrupt progression from casual or episodic abuse to dependence.
16128936|NCT01942798|Device|Nintendo Wii|Subjects will receive the intervention for 40-minute sessions, 3x/week for 4 weeks. The interventions will be administered in combination of onsite group training and individualized home-based training.
16128937|NCT01942798|Device|Wii Big Brain Academy Degree program|Subjects will receive the intervention for 40-minute sessions, 3x/week for 4 weeks. The interventions will be administered in combination of onsite group training and individualized home-based training.
16128938|NCT01942785|Drug|Brexpiprazole|2-3 mg/day, once daily dose, tablets, for oral use. The patients received 1mg/day brexpiprazole during Week 1 and 2mg/day during Week 2 (up-titration) and from Weeks 3 to 6 they received 3mg/day; depending on tolerability the dose could be reduced to 2mg/day based on the investigator's judgement.
16128939|NCT01942772|Device|Ankle-Foot Orthosis|
16128940|NCT01942746|Dietary Supplement|Blueberry Juice S2|Blueberry Juice S2 was commercially prepared single strength blueberry juice composed of a 50:50 blend of Rubel (Vaccinium corymbosum L.) and Tifblue (Vaccinium ashei Reade) cultivars. Colorimetric analysis showed that S2 juice contained 6.04 (SD=0.20) mg anthocyanins (C3G) eq/g dry mass.
16128941|NCT01942746|Dietary Supplement|Blueberry Capsules S2|Commercially prepared single strength blueberry juice composed of a 50:50 blend of Rubel (Vaccinium corymbosum L.) and Tifblue (Vaccinium ashei Reade) cultivars was freeze dried then powdered and encapsulated in gelatin capsules. Colorimetric analysis indicated an anthocyanin concentration in the powder of 2.37(SD=0.18) mg C3G eq per capsule.
16128942|NCT01942746|Dietary Supplement|Placebo Capsule S2|Placebo Capsule S2 (containing no anthocyanins) were prepared by freeze drying red beets and grinding them to fine powder before encapsulating in gelatine capsules. Red beets do not contain anthocyanins.
16128943|NCT01942746|Dietary Supplement|Placebo Juice L1|Placebo juice was prepared from water, sugars, citric acid, sodium citrate, and artificial colors and flavours, then pasteurized. The placebo juice contains no anthocyanins.
16128944|NCT01942746|Dietary Supplement|Blueberry Juice L1|Blueberry Juice L1 was commercially prepared single strength blueberry juice composed of a 50:50 blend of Rubel (Vaccinium corymbosum L.) and Tifblue (Vaccinium ashei Reade) cultivars. Colorimetric analysis showed that L1 juice contained 6.83 (SD=0.20) mg cyanidin-3-glucoside equivalents (C3GE)/g dry mass at the start of the study, declining to 5.52 (SD=0.09) mg C3GE/g dry mass after 3 months refrigerated storage.
16128945|NCT01942733|Drug|Brexpiprazole|2-3 mg/day, once daily, tablets, for oral use. The patients received 1mg/day brexpiprazole during Week 1 and 2mg/day during Week 2 (up-titration) and from Weeks 3 to 6 they received 3mg/day; depending on tolerability the dose could be reduced to 2mg/day based on the investigator's judgment.
16128946|NCT01942720|Device|Capsule endoscopy and Ileocolonoscopy tests|
16128947|NCT01942707|Procedure|abdominoplasty with Scarpa's Fascia|During surgical detachment of the abdominal flap the Scarpa´s fascia is preserved.
16128948|NCT01942707|Procedure|Abdominoplasty without Scarpa´s Facia|During surgical detachment of the abdominal flap the Scarpa´s fascia is removed.
16128949|NCT01942694|Dietary Supplement|Vitamin D (Cholecalciferol)|Vitamin D (Cholecalciferol) 4000 IU, administered as 1 soft-gel pill daily by mouth.
16128950|NCT01942694|Other|Placebo|Administered as one soft-gel pill daily by mouth
16128951|NCT01942681|Drug|Propiverine Hydrochloride|Administrate Propiverine Hydrochloride for 12 weeks
16128952|NCT01942668|Drug|Estradiol|
16128953|NCT01942668|Drug|Progesterone|
16128954|NCT01942668|Drug|Placebo|
16128955|NCT01942655|Other|Blood sample and recto-colic biopsies|
16128956|NCT01942629|Other|their will be no intervention in any of the groups, the study is retrospective|
16128957|NCT01942616|Other|Condition 1: Perpetrator Positive|Condition 1 frames the event as episodic, labels the event as domestic violence, uses a positive description of the perpetrator, and a negative description of the victim.
16128958|NCT01942616|Other|Condition 2: Perpetrator Negative|The condition 2 intervention/exposure frames the event as thematic, labels the event as assault, uses a neutral description of the perpetrator, and a negative description of the perpetrator.
16128959|NCT01942616|Other|Condition 3: Placebo|This intervention provides no details for the participant and is for comparison use in the study.
16128960|NCT01942590|Drug|Clenbuterol|
16128961|NCT01942590|Drug|Placebo|
16128962|NCT01942577|Device|NoSting|Each participant with get both interventions. The infant's NoSting treated thigh will be sprayed with NoSting following delivery and again at 7 days of age. A quarter 1.5 x 3 inch silicon patch that is applied to the infant's thighs will be used for data sampling.
16128963|NCT01942551|Drug|Tadalafil|
16128964|NCT01942551|Drug|Dutasteride|
16128965|NCT01942538|Device|rTMS|one session : 20 runs of 10 seconds high frequency stimulation(10Hz) and 50 seconds pause - power equivalent to 90% of the motor threshold
16128966|NCT01942538|Device|sham rTMS|same session as defined with the real rTMS, but with a coil not delivering magnetic field.
16128967|NCT01942525|Other|aEEG|The amplitude integrated EEG was performed using a single-channel, biparietal aEEG (CFM 6000; Natus Medical Incorporated, San Carlos, CA)
16128968|NCT01942512|Device|Endovascular treatment of intracranial aneurysm|
16128969|NCT01942499|Other|Community-based exercise program|
16128970|NCT01942486|Device|Investigational Coating|
16128971|NCT01942473|Device|Automated FiO2 Control|Infants will be ventilated with or without automated FiO2-Control in a randomized sequence.
16128972|NCT01942460|Drug|Ferumoxytol|
16128973|NCT01942447|Biological|FMT|
16128974|NCT01942447|Drug|Vancomycin|
16128975|NCT01942421|Procedure|Cultivated mucosal epithelial transplantation|cultivated autologous mucosal epithelium, then transplant to limbal stem cell deficiency patients.
16128976|NCT01942408|Procedure|Repeat PVI|Repeat EP study 8-10 weeks post-initial PVI with re-isolation of PV reconnection
16129095|NCT01941524|Drug|Beractant instillation|aEEG and NRs monitoring during beractant instillation
16128977|NCT01942395|Behavioral|DASH/sodium-restricted diet (DASH/SRD)|Baseline diet will be assessed via Block Food Frequency Questionnaire, and 24-hour urinary sodium, potassium, and 8-isoprostanes will be measured. Subjects will then be assigned to 21 days of the DASH/SRD, with all food and beverages provided. The target sodium content will be 1,500 mg/2,100 kcal, as per recent American Heart Association population recommendations for sodium intake. Adherence will be assessed through a three-day food diary at the midpoint of the intervention, and at the end of the 21 days urinary sodium, potassium, and 8-isoprostanes will again be measured.
16128978|NCT01942395|Behavioral|Control Diet|The Control Diet will be patterned on the information we collected using Food Frequency Questionnaires during our pilot study HUM00025253 (i.e., the dietary patterns reported by previously recruited hypertensive HFPEF patients). The target sodium content will be 3,500 mg per 2,100 kcal and target potassium content for the control diet will be 2,000 mg per 2,100 kcal.
16128979|NCT01942382|Drug|Paliperidone palmitate|Participants will receive 4 injections of paliperidone palmitate of concentration ranging from 75 to 150 milligram equivalents in deltoid or gluteal muscle as randomized to treatment group A, B, or C on Days 1, 8, 36, and 64.
16128980|NCT01942369|Drug|Triptorelin Acetate 3.75mg intramuscular injection|"Triptorelin Acetate is a Gonadotrophin Releasing Hormone agonist (GnRHa).
~Triptorelin acetate for injection 3.75mg administered as described in the patient information sheet approved in China: one intramuscular injection of the product repeated every 4 weeks."
16128981|NCT01942356|Procedure|TIVA - Hypotension|"Defined as: MAP < 70% of baseline Change NIBP (noninvasive blood pressure) measuring interval from 3 minutes to 1 minute until resolution of the event.
~Give 200 mL Fluid Bolus
~If not successful, give ephedrine 5 mg bolus
~Repeat from 1.) if even is not resolved after 3.)"
16128982|NCT01942356|Procedure|TIVA - Hypertension|"Defined as: SBP > 130% of baseline sustained for 2 readings Change NIBP (noninvasive blood pressure) measuring interval from 3 minutes to 1 minute until resolution of the event.
~1.) Labetalol 5 mg IV will be administered"
16128983|NCT01942356|Procedure|TIVA - Bradycardia|"Defined as: Heart rate < 45 beats/min
~1.) Bolus of 0.2 mg glycopyrrolate"
16128984|NCT01942356|Procedure|TIVA - Tachycardia|"Defined as: Heart Rate > 90 beats/min
~If associated with normal NIBP (MAP > 60 mmHg and SAP < 140): give fluid bolus of 200 mL, repeat once if required. Look for bleeding and treat if required.
~If associated with hypertension (SAB > 140 mmHg): proceed with the management of the hypotention during maintenance protocol.
~If associated with hypotension (MAP < 60 mmHg): proceed with the management of the hypotnetion during maintenance protocol."
16128985|NCT01942356|Procedure|INH - Hypotension|"Defined as: MAP < 70 % of baseline Change NIBP measuring interval from 3 minutes to 1 minute until resolution of the event.
~give a 200 ml fluid bolus (crystalloid).
~If not successful, give ephedrine 5 mg bolus.
~If not successful decrease volatile by 0.1 MAC.
~Repeat from 1) if event is not resolved after step 3) for maximum of 2 iterations"
16128986|NCT01942356|Procedure|INH - Hypertension|"Defined as: SBP > 130% of baseline Change NIBP measuring interval from 3 minutes to 1 minute until resolution of the event.
~increase Sevoflurane by 0.1 MAC
~If not successful after 3 minutes (SBP >130% of baseline), increase Sevoflurane again by 0.1 MAC. Maximum of 1.2 allowed.
~If still not successful (SBP >130% of baseline), Labetolol 5mg IV will be administered."
16128987|NCT01942356|Procedure|INH - Bradycardia|"Defined as: Heart Rate < 45 beats/min
~1.) Bolus of 0.2 mg glycopyrrolate"
16128988|NCT01942356|Procedure|INH - Tachycardia|"Defined as: Heart rate > 90 beats/min
~if associated with normal NIBP (MAP > 70% of baseline and SBP <130% of baseline) : give fluid bolus of 200 ml, repeat once if required. (look for bleeding and treat if required).
~If associated with hypertension (SBP >130% of baseline) : proceed with the management of the hypertension during maintenance protocol.
~If associated with hypotension (MAP < 70% of baseline) : proceed with the management of the hypotension during maintenance protocol."
16128989|NCT01942343|Drug|Droperidol 1,25 mg administration, Droperidol 0,625 mg administration, Odansetron 4 mg administration|
16128990|NCT01942330|Procedure|Laparoscopic-Assisted Natural Orifice Surgery|Surgical procedure performed using an operating endoscope that is introduced into the body through a natural orifice and is then passed into the peritoneal cavity through the lumen of an organ such as the stomach, bowel or vagina.
16128991|NCT01942317|Other|Balneotherapy|
16128992|NCT01942304|Procedure|Calcium phosphosilicate alloplastic bone putty in direct sinus augmentation|
16128993|NCT01942304|Procedure|Anorganic bovine bone mineral in direct sinus augmentation|
16128994|NCT01942291|Drug|Niacin|The study was randomized, double-blind, controlled, using a 2-way crossover design with both treatment periods and washout time lasting 7 days. Subjects were allocated by simple randomization to extended-release niacin 1g/day alone (ERN, Metri, Libbs Farmacêutica, São Paulo, Brazil) or niacin associated with LRPT 1g/20mg (ERN/LRPT, Cordaptive, Merck, São Paulo, Brazil).
16128995|NCT01942278|Other|BHOMA|A complex health systems, clinical care, and community intervention to improve outcomes
16128996|NCT01942265|Drug|AS03|Subjects will receive two doses of the A/H7N9 vaccine with or without AS03 delivered intramuscularly 21 days apart.
16128997|NCT01942265|Drug|MF59|Subjects will receive two doses of the A/H7N9 vaccine with or without MF59 delivered intramuscularly 21 days apart.
16128998|NCT01942265|Biological|Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013|Subjects will receive two doses of the A/H7N9 vaccine with or without an adjuvant delivered intramuscularly approximately 21 days apart.
16128999|NCT01942239|Device|real time continuous glucose monitoring|
16129000|NCT01942187|Drug|Aripiprazole|Medication augmentation with Abilify (aripiprazole), in participants who have not responded to Selective Serotonin Reuptake Inhibitor (SSRI) treatment.
16129001|NCT01942187|Drug|Bupropion|Medication augmentation with Wellbutrin (bupropion), in participants who have not responded to SSRI treatment.
16129002|NCT01942187|Behavioral|Problem Solving Therapy|Weekly specialized psychotherapy
16129003|NCT01942174|Biological|Prevenar 13|Vaccination at the beginning of the study (day 0)
16129004|NCT01942174|Biological|Pneumo23 / Pneumovax|Vaccination 2 months later the beginning of the study NB : Vaccine Pneumo23 has been replaced by equivalent vaccine Pneumovax in September 2017 because of the stop of commercialization of Pneumo23 in France by the pharmaceutical company
16129005|NCT01942174|Drug|Methotrexate - Immediate|concerning immediate group, methotrexate is Initiated in the same time that the antipneumococcal vaccination by prevenar 13
16129006|NCT01942174|Drug|Methotrexate - Delay|"For period group, methotrexate is Initiated & month after the antipneumococcal vaccination by prevenar 13"
16129008|NCT01942161|Drug|Aripiprazole Mid (6 - 12 mg/day)|administered 2 mg once daily for 2 days, followed by a maintenance dose of 6 mg for 40 days. From Day 15 onwards, the dose may be increased to 12 mg
16129009|NCT01942161|Drug|Aripiprazole High (24 - 30 mg/day)|administered 2, 6, 12, 18 mg sequentially, each dose once daily for 2 days respectively, followed by a maintenance dose of 24 mg for 34 days. From Day 15 onwards, the dose may be increased to 30 mg
16129010|NCT01942148|Drug|Aripiprazole|
16129015|NCT01942122|Drug|DLBS1442 100|Study treatment will be DLBS1442 capsules at a dose of 3x100 mg daily. DLBS1442 will be taken every day for 8 weeks (2 menstrual cycles).
16129016|NCT01942122|Drug|Mefenamic acid|Control will be mefenamic acid 500 mg tablets, administered 3 times daily for 5 days during the menstrual period, i.e. day 1st to day 5th of the menstrual period. The drug will be given within the 8 weeks of study period (2 menstrual cycles).
16129017|NCT01942122|Drug|DLBS1442 200|Study treatment will be DLBS1442 capsules at a dose of 3x200 mg daily. DLBS1442 will be taken every day for 8 weeks (2 menstrual cycles).
16129018|NCT01942109|Drug|Furosemide|Drug will be administered per os. Dose of the agent will be adapted to clinical status of the patient. Equipotential dose for furosemide is torasemide in dose 1:4 of furosemide
16129019|NCT01942109|Drug|Torasemide|Drug will be administered per os. Dose of the agent will be adapted to clinical status of the patient. Equipotential dose for furosemide is torasemide in dose 1:4 of furosemide
16129020|NCT01942083|Drug|OPB-111077|
16129021|NCT01942070|Device|Bioresorbable vascular scaffold|
16129022|NCT01942070|Device|Durable polymer everolimus-eluting metallic stent|
16129023|NCT01942044|Device|Promus element, Xience prime, and Nobori|
16129024|NCT01942031|Behavioral|structured collegial feed back|Collegial feed back to primary care physicians at randomized primary care centers
16129025|NCT01942018|Procedure|POEM|Patients will receive Per oral endoscopic myotomy (POEM) for symptomatic gastroesophageal junction outflow obstruction (EGOO)
16129026|NCT01941992|Drug|SAMITAL®|
16129027|NCT01941992|Drug|Placebo sachets|
16129028|NCT01941979|Drug|5-FU, Capecitabine, Oxaliplatin, Leucovorin.|
16129029|NCT01941966|Drug|Capecitabine|Capecitabine, PO, 825mg/m2, on days: 1, 2, 3, 4, 5, 8, 9, 10, 11, 12, 15, 16, 17, 18, 19, 22, 23, 24, 25, 26, 29, 30, 31, 32, 33, 36, 37, 38, 39 and 40 of radiotherapy period.
16129030|NCT01941966|Drug|Mitomycins|15 mg/m2, IV, bolus, single dose on day 1 of radiotherapy
16129031|NCT01941966|Radiation|Radiotherapy|Dose: 50,4-54 Gy 28 to 30 fractions during 5 to 6 weeks
16129032|NCT01941953|Drug|Metformin and Fluorouracil|metformin 850mg PO BID plus 5FU 425mg/m2 + leucovorin 50mg IV weekly
16129033|NCT01941940|Drug|Tocilizumab|Tocilizumab at a fixed dose of 162 mg as SC injection will be administered once every week.
16129034|NCT01941940|Drug|DMARDs|Non-biologic DMARDs according to standard of care, at a stable dose that was initiated at least 4 weeks prior to baseline.
16129035|NCT01941927|Drug|Trametinib (GSK1120212)|Trametinib is a highly selective allosteric inhibitor of MEK1 and MEK2 activation and kinase activity.
16129036|NCT01941927|Drug|GSK2141795|GSK 2141795 is an ATP competitive subnanomolar pan-AKT inhibitor. In order to measure the true potency of GSK 2141795, potency (Ki*) values were determined in a filter binding assay using lower enzyme concentrations (0.1, 0.7, and 0.2 nM for human AKT1, AKT2, and AKT3, respectively). Using a sandwich ELISA, GSK 2141795 inhibited phosphorylation of GSK-3β in BT474 and LNCaP cell lines with EC50 values of 143 and 34 nM, respectively. Since phosphorylation of GSK-3β can be modulated by other enzymes (PKA, PKC, and RSK),cellular activity of GSK 2141795 was evaluated using a phospho-PRAS40 ELISA. GSK 2141795 inhibited the phosphorylation of PRAS40 with EC50 values of 39 and 55 nM for BT474 and LNCaP cells, respectively.
16129037|NCT01941914|Drug|Calcium chloride|
16129038|NCT01941901|Drug|Calcium electroporation|Intratumoral injection, once only treatment.
16129039|NCT01941901|Drug|Electrochemotherapy with bleomycin|Intratumoral injection, once only treatment
16129040|NCT01941888|Drug|Propofol|
16129041|NCT01941888|Drug|Midazolam|
16129042|NCT01941888|Device|Target Controlled Infusion|
16129043|NCT01941875|Drug|Progesterone Effervescent Vaginal Tablets|Experimental
16129044|NCT01941862|Behavioral|Psychoeducation and Cognitive Bias Modification|
16129045|NCT01941849|Drug|Vandetanib|100 mg, 200 mg or 300 mg taken once a day during each 12-weekly cycle
16129046|NCT01941849|Radiation|131I-mIBG|Activity will be prescribed to deliver whole body absorbed dose of 0.5 Gy (+/-10%)
16129047|NCT01941836|Drug|ETC-1002|Patients receive ETC-1002
16129048|NCT01941836|Drug|Ezetimibe|Patients receive ezetimibe
16129049|NCT01941810|Dietary Supplement|bovine lactoferrin supplement|Given PO
16129050|NCT01941810|Other|questionnaire administration|Ancillary studies
16129051|NCT01941810|Procedure|quality-of-life assessment|Ancillary studies
16129052|NCT01941810|Other|laboratory biomarker analysis|Correlative studies
16129053|NCT01941797|Behavioral|interruption of oral hygiene|
16129054|NCT01941784|Other|educational intervention|Undergo health education program
16129055|NCT01941784|Other|counseling intervention|Undergo health education program
16129056|NCT01941784|Behavioral|telephone-based intervention|Receive follow-up phone calls
16129057|NCT01941784|Other|questionnaire administration|Ancillary studies
16129058|NCT01941784|Procedure|quality-of-life assessment|Ancillary studies
16129059|NCT01941771|Drug|Arm B Vinorelbine (Navelbine oral) Capecitabine (Xeloda)|Oral Vinorelbine (Navelbine oral) 50 mg 3 times weekly, monday, wednesday and friday plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1-14 in a 3 weekly schedule.
16129096|NCT01941511|Drug|Rivipansel|Subjects will receive in a randomized sequence rivipansel 4gA IV, moxifloxacin 400 mg, and placebo IV.
16129060|NCT01941771|Drug|Arm A Vinorelbine (Navelbine oral) Capecitabine (Xeloda)|Vinorelbine (Navelbine Oral) 60 mg/m2 day 1 and day 8 Plus Capecitabine (Xeloda) 1000 mg/m2 2 times daily day 1 to 14 in a 3 weekly schedule.
16129061|NCT01941758|Biological|trivalent influenza vaccine|
16129062|NCT01941758|Other|laboratory biomarker analysis|Correlative studies
16129063|NCT01941745|Drug|Half normal saline|2 ml/kg
16129064|NCT01941745|Drug|Low Dose rhCC10|1.5 mg/kg study drug (rhCC10)
16129065|NCT01941745|Drug|High dose rhCC10|5 mg/kg in 2 ml/kg
16129066|NCT01941732|Drug|Sildenafil|
16129067|NCT01941719|Behavioral|Enhanced foot care education|Personalized, computer-animated plantar pressure maps in both barefoot and in-shoe conditions were demonstrated once at baseline visit. The demonstration includes diabetic foot education on the topic of diabetic neuropathy and how barefoot walking can lead to skin breakdown and ulcer formation, which can lead to infection and eventual amputation. The education also highlights the high plantar pressures experienced by individuals while barefoot versus in-shoe and how proper footwear is necessary in conjunction with other standard self-foot care measures to prevent injury and complications.
16129068|NCT01941719|Behavioral|Standard Foot Care Education|"At baseline, a trained staff individually reviewed and dispensed the following brochures: Prevent diabetes problems: Keep your diabetes under control (NIH Publication No. 07-4349) and Prevent diabetes problems: Keep your feet and skin healthy (NIH Publication No. 07-4282) along with a 1-page summary of each brochure. Also, a 1-page supplementary diabetic shoe wear educational material was reviewed and dispensed. Keep your diabetes under control stresses sugar, blood pressure, and medication control, and nutrition and physical activity, and checking feet daily for cuts, blisters, sores, swelling, redness, or sore toenails. Keep your skin and feet healthy emphasizes the importance of checking feet daily, highlighting diabetic foot complications that can arise from neuropathy, poor circulation and dry skin, and the importance of supportive, protective, and accommodative shoewear and annual foot exams."
16129069|NCT01941706|Behavioral|Project UPLIFT|Developed for home-based treatment of depression in people with epilepsy, Project UPLIFT is based upon Mindfulness-based Cognitive Therapy for depression. It includes 8 modules, group-delivered by either telephone or Web. Trainees and people with epilepsy co-facilitate the groups, supervised by a licensed mental health professional.The co-facilitators are trained and supervised by the Principal Investigator, a Georgia-licensed clinical psychologist and Associate Professor of Behavioral Science and of Epidemiology in public health. Activities are designed to increase knowledge about depression; monitoring, challenging, and changing thoughts; coping and relaxing; attention and mindfulness; focusing on pleasure; the importance of reinforcement, and preventing relapse.
16129070|NCT01941693|Behavioral|Integrated care|Intervention for co-morbid alcohol dependence and anxiety or mood disorder. Trained therapists will deliver specific Cognitive Behavioural Therapy based upon interventions that have been supported by randomised controlled trials for alcohol use, anxiety, and depressive disorders.
16129071|NCT01941693|Behavioral|Usual care|Counselling for all subjects will continue in accord with standard practice. Currently, programs of brief individualized motivation enhancement therapy (feedback of assessment findings, reinforcement, empathy, client's own motivation) are available.
16129072|NCT01941667|Behavioral|Daily Messages, Virtual Home Visits|"Intervention includes: Measuring daily weights, 24 hour intake, heart rate, oxygen level
~Daily messages requesting weight, intake, pulse ox and pulse are automated
~Virtual home visits occur twice weekly where the investigators see the infant and families."
16129073|NCT01941667|Other|Usual Care|Usual care as defined by by the Cardiology Department.
16129074|NCT01941654|Radiation|preemptive local ablative therapy|
16129075|NCT01941654|Drug|Oral TKI|
16129076|NCT01941641|Drug|neoadjuvant FOLFOXIRI|
16129077|NCT01941641|Drug|Capecitabine|
16129078|NCT01941628|Drug|Rocuronium|Rocuronium 0.6 mg/kg will be used as muscle relaxant to allow intubation during induction into general anesthesia and to induce deep neuromuscular blockade for the surgery. Deep neuromuscular blockade will be maintained until the suture of fascia of musculus rectus abdominis.
16129079|NCT01941628|Drug|Succinylcholine|Standard induction into general anesthesia with succinylcholine 1 mg/kg will be performed. No other muscle relaxant will be administered during the Caesarean section until surgeon would request it. In that case, according to general standards, dose of atracurium 0.25 mg/kg will be administered.
16129080|NCT01941615|Drug|faldaprevir|oral doses for 10 days (period B)
16129081|NCT01941615|Drug|Microgynon®|oral doses for 23 days (period A+B)
16129082|NCT01941615|Drug|BI 207127|oral doses for 10 days (period B)
16129083|NCT01941602|Drug|prophylactic enoxaparin|enoxaparin had been prescribed at a dose of 40 mg (once daily) from the evening before surgery until patients were well mobilized. Also, at the time of surgery compression stockings were used, as well as a sequential compression device (SCD) until the morning after or longer if mobilization was delayed
16129084|NCT01941602|Procedure|non-prophylactic|no pharmacological prophylaxis for venous thromboembolism (VTE) had been used routinely. Occasionally, with delayed mobilization, a low-dose low molecular weight heparin (LMWH) had been prescribed. SCD had been used at increased frequency, and is today considered routine.
16129085|NCT01941589|Drug|oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone|maximal oral 5-ASA+/-topical 5-ASA+IV corticosteroids
16129086|NCT01941589|Drug|corticosteroids only|IV corticosteroids only
16129087|NCT01941576|Drug|recombinant human brain natriuretic peptide (rhBNP)|Patients are first given a loading dose of recombinant human brain natriuretic peptide (rhBNP) 1.5 mcg/kg, followed by continuous infusion recombinant human brain natriuretic peptide 0.01-0.01mcg/kg/min for 72 hours.
16129088|NCT01941576|Drug|Placebo (0.9% sodium chloride)|Patients after corrective repair of Tetralogy Of Fallot will be treat with routinely therapy, including inotropics and diuretics, combined a placebo infusion 24 hours after operation.
16129089|NCT01941563|Drug|Condoliase|1.25U, intradiscal injection, one time
16129090|NCT01941563|Drug|placebo|
16129091|NCT01941550|Drug|Cabazitaxel chemotherapy|given in 6 cycles
16129092|NCT01941537|Drug|ILV-094|IV infusion of ILV-094
16129093|NCT01941537|Drug|Placebo Comparator|Twenty patients will be enrolled in the ILV-094 placebo arm. A loading IV dose of a placebo will be given at baseline (Day 0), followed by five additional IV doses of placebo every two weeks (Weeks 2, 4, 6, 8, and 10).
16129094|NCT01941524|Drug|Poractant alfa instillation|aEEG and NIRS monitoring during poractant alfa instilation
16129097|NCT01941498|Device|Wavelight® Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers (Wavelight® Refractive Suite) used during LASIK surgery for corneal flap creation and corneal ablation
16129098|NCT01941498|Procedure|LASIK surgery|Surgical procedure for treating refractive error based on corneal reshaping
16129099|NCT01941485|Device|WaveLight® Refractive Suite|Excimer EX500 and Femtosecond FS200 lasers (Wavelight® Refractive Suite) used during LASIK surgery for corneal flap creation and corneal ablation
16129100|NCT01941485|Procedure|LASIK surgery|Surgical procedure for treating refractive error based on corneal reshaping
16129101|NCT01941472|Other|fluid challenge|A bag of 500ml of normal saline or 4% gelatin (Gelofusine, B. Braun Medical (Suzhou) Company Limited, Suzhou, China) is infused within 15 minutes using a bag pressurized to 300 mmHg. All other treatments, including maintenance fluids, dose of vasoactive agents and ventilator settings, remain unchanged during the study period.
16129102|NCT01941446|Drug|Eravacyline and Moxifloxacin|
16129103|NCT01941433|Behavioral|Arthritis Health Journal|
16129104|NCT01941407|Drug|Eribulin|Eribulin: 1,23mg/m² d1, d8, IV Bevacizumab: 15mg/kg d1, IV
16129105|NCT01941394|Biological|Mesenchymal stem cells|Mesenchymal stem cells infusion
16129106|NCT01941381|Procedure|Tympanometry|All patients enrolled with receive a tympanogram. There will be no difference between the follow up in the groups based on the tympanometry results. The study is simply observational
16129107|NCT01941368|Dietary Supplement|Placebo|
16129108|NCT01941368|Dietary Supplement|HMB-FA|
16129109|NCT01941368|Procedure|High Intensity Interval Training|
16129110|NCT01941355|Behavioral|Exercise training component|The physical exercises consist of; deep breathing exercises and breathing exercises using incentive spirometry with expiratory positive pressure airway, cycling exercises during hospitalisation and an individualised exercise programme running from discharge to 4 weeks following surgery.
16129111|NCT01941355|Behavioral|Psycho-educative component|The psycho-educative rehabilitation programme consists of four psycho-educative consultations with a specially trained nurse. The last consultation will take place 4 weeks following surgery.
16129112|NCT01941342|Procedure|Pancreatoduodenectomy|
16129113|NCT01941342|Procedure|ENBD and Pancreatoduodenectomy|
16129114|NCT01941342|Procedure|EBD and Pancreatoduodenectomy|
16129115|NCT01941342|Procedure|PTCD and Pancreatoduodenectomy|
16129116|NCT01941329|Procedure|Panretinal Photocoagulation (PRP)|
16129117|NCT01941329|Drug|Intravitreous injection of ranibizumab|
16129118|NCT01941316|Drug|Carfilzomib|20/36 * mg/m2 stepped up dosing, IV infusion (over 30 min), on days 1, 2, 8, 9, 15 and 16 of each 28 day cycle. Number of cycles: 6, or until progression, or unacceptable toxicity, or treatment delay for any reason greater than 3 weeks.
16129119|NCT01941316|Drug|Irinotecan|125 mg/m2, IV infusion (over 90 min), on days 1, 8, 15 of each 28 day cycle. Number of cycles: 6, or until progression, or unacceptable toxicity, or treatment delay for any reason greater than 3 weeks.
16129120|NCT01941277|Behavioral|Current Recommendations Exercise Group|
16129121|NCT01941277|Behavioral|Intensive Exercise Group|
16129122|NCT01941264|Other|community based screening and treatment|Already described in intervention arm description.
16129123|NCT01941251|Device|navigated Transcranial Magnetic Stimulation|"individualized α frequency
~left DLPFC 110% motor threshold (MT)
~13-15 sessions for 3 weeks"
16129124|NCT01941251|Device|navigated Transcranial Magnetic Stimulation|- placebo treatment: sham coil
16129125|NCT01941225|Drug|Inhaled iloprost 5.0 mcg|Single administration
16129126|NCT01941225|Drug|Placebo|Single administration
16129127|NCT01941212|Behavioral|Music therapy|Music therapy will be given to patients 24 hours prior and for the first 48 hours after surgery
16129128|NCT01941199|Drug|DA-1229|
16129129|NCT01941199|Drug|metformin|
16129130|NCT01941199|Drug|DA-1229 + metformin|
16129131|NCT01941186|Other|Patient Decision Aid|Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services.
16129132|NCT01941173|Biological|ziv-aflibercept|Given IV
16129133|NCT01941173|Drug|leucovorin calcium|Given IV
16129134|NCT01941173|Drug|irinotecan hydrochloride|Given IV
16129135|NCT01941173|Drug|fluorouracil|Given IV
16129136|NCT01941160|Dietary Supplement|Lacidofil® STRONG|Lacidofil® STRONG capsule twice daily
16129137|NCT01941160|Dietary Supplement|Placebo|Placebo capsule twice daily
16129138|NCT01941147|Device|pulsed ELF-MF|(75 Hz, 1,8 mT)
16129139|NCT01941134|Drug|ethinyl estradiol-levonorgestrel|Women will be asked to take a daily ethinyl estradiol-levonorgestrel combined oral contraceptive (COC) for 21 days, beginning 2-3 months pre-operatively, so as to stop at least 30 days before planned surgery date. Then, approximately 3-4 months after surgery, they will again be asked to take a daily pill for 21 days. During these pill cycles, we will collect serum samples and perform ultrasound and cervical mucus assessments on a twice-weekly basis, culminating in an inpatient stay of up to 48 hours in order to obtain more frequent sampling at the end of the pill pack.
16129140|NCT01941121|Behavioral|Linkage to PrEP or Care|Ensuring subjects complete linkage to PrEP or Care through coordinated scheduling and intensive reminders by ALERT Specialist.
16129141|NCT01941108|Behavioral|Peer Navigation Arm|Patients randomized to this arm receive regular contact with a peer navigator and a smartphone running eMOCHA software to aid in navigation.
16129142|NCT01941095|Drug|Azathioprine|Participants may receive azathioprine as a concomitant therapy with tocilizumab as per physician's judgment at a stable dose that was initiated at least 4 weeks prior to baseline.
16129143|NCT01941095|Drug|Chloroquine|Participants may receive chloroquine as a concomitant therapy with tocilizumab as per physician's judgment at a stable dose that was initiated at least 4 weeks prior to baseline.
16129144|NCT01941095|Drug|Hydroxychloroquine|Participants may receive hydroxychloroquine as a concomitant therapy with tocilizumab as per physician's judgment at a stable dose that was initiated at least 4 weeks prior to baseline.
16129145|NCT01941095|Drug|Leflunomide|Participants may receive leflunomide as a concomitant therapy with tocilizumab as per physician's judgment at a stable dose that was initiated at least 4 weeks prior to baseline.
16129146|NCT01941095|Drug|Methotrexate|Participants may receive methotrexate as a concomitant therapy with tocilizumab as per physician's judgment at a stable dose that was initiated at least 4 weeks prior to baseline.
16129147|NCT01941095|Drug|Sulfasalazine|Participants may receive sulfasalazine as a concomitant therapy with tocilizumab as per physician's judgment at a stable dose that was initiated at least 4 weeks prior to baseline.
16129148|NCT01941095|Drug|Tocilizumab|Participants will receive tocilizumab at a fixed dose of 162 mg SC QW either as monotherapy or in combination with non-biologic DMARDs.
16129149|NCT01941082|Drug|RO6867461|Single or multiple ascending dose by intravitreal injection
16129150|NCT01941069|Behavioral|Friends for Life|Friends for Life is a group CBT intervention, based on a theoretical model, which addresses cognitive, physiological and behavioral processes that are seen to interact in the development and perpetuation of excessive anxiety.
16129151|NCT01941069|Behavioral|Coping Power Program|The Coping Power Program CPP is a cognitive-behavioral, multi-component group intervention for elementary and middle school students at risk for externalizing behavior disorders. In addition to anger management, the CPP includes units on goal setting, emotional awareness, relaxation training, social skills training, problem solving, and handling peer pressure.
16129152|NCT01941056|Biological|multi-CMV epitope modified vaccinia Ankara vaccine|Given IM
16129153|NCT01941056|Other|laboratory biomarker analysis|Correlative studies
16129154|NCT01941043|Drug|CERC-301|
16129155|NCT01941043|Other|Placebo|
16129156|NCT01941030|Device|Orbital Atherectomy System|Orbital atherectomy (OA) is performed prior to adjunctive balloon angioplasty (BA)
16129157|NCT01941030|Device|Balloon Angioplasty|Type of balloon selected is driven by preference of the operator.
16129158|NCT01941004|Drug|fingolimod|Randomized to 6 month (180 days) 0.5 mg fingolimod + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily
16129159|NCT01941004|Drug|Placebo (6mos) + open label fingolimod (6 mos)|Randomized to 6 month (180 days) matching placebo + 6 month (180 day) open label 0.5mg fingolimod capsules for oral administration once daily
16129160|NCT01940991|Drug|Placebo|Placebo, Dose B; dose applied to the lateral canthal lines
16129161|NCT01940991|Drug|Botulinum Toxin Type A|Botulinum Toxin Type A, Dose A, dose applied to the lateral canthal lines
16129162|NCT01940978|Drug|Methylphenidate ER|Watson generic, starting dose 18mg QD
16129163|NCT01940978|Drug|Cyproheptadine|cyproheptadine hydrochloride
16129164|NCT01940965|Drug|lixisenatide AVE0010|Pharmaceutical form:solution Route of administration: Subcutaneous injection
16129165|NCT01940965|Drug|biguanide|Pharmaceutical form:tablet Route of administration: oral
16129166|NCT01940965|Drug|TZD|Pharmaceutical form:tablet Route of administration: oral
16129167|NCT01940965|Drug|alpha-GI|Pharmaceutical form:tablet Route of administration: oral
16129168|NCT01940965|Drug|glinide|Pharmaceutical form:tablet Route of administration: oral
16129169|NCT01940952|Drug|Zydena (Udenafil) 50mg + Donepezil 5mg or 10mg|
16129170|NCT01940952|Drug|Placebo + Donepezil 5mg or 10mg|
16129171|NCT01940952|Drug|Zydena (Udenafil) 100mg + Donepezil 5mg or 10mg|
16129172|NCT01940939|Device|Repetitive Transcranial Magnetic Stimulation|The MagPro X100 is connected to a Magnetic Coil which transfers the magnetic stimulation to the tissue. The original coils MC-B65 can be used with the MagPro X100.
16129173|NCT01940926|Drug|68Ga-BNOTA-PRGD2|Single dose intravenous injection of nearly 111 MBq 68Ga-BNOTA-PRGD2 at 30 minutes before PET/CT scanning
16129174|NCT01940913|Dietary Supplement|Probiotic capsules|
16129175|NCT01940913|Dietary Supplement|Placebo capsules|
16129176|NCT01940900|Drug|E10030|
16129177|NCT01940900|Drug|ranibizumab|
16129178|NCT01940900|Drug|E10030 sham intravitreal injection|Pressure on the eye with a syringe with no needle
16129179|NCT01940887|Drug|E10030|
16129180|NCT01940887|Drug|bevacizumab or aflibercept|Patients are randomized to receive either bevacizumab or aflibercept
16129181|NCT01940887|Drug|E10030 sham injection|Pressure on the eye with a syringe with no needle
16129182|NCT01940848|Drug|STW5 (Iberogast, BAY98-7411)|Applied orally over 28 days, 20 drops STW 5 three times daily
16129183|NCT01940848|Drug|Placebo|Applied orally over 28 days, 20 drops placebo three times daily
16129184|NCT01940835|Procedure|Upper endoscopy with small bowel biopsies and brushings.|
16129185|NCT01940835|Other|Blood draw|Blood will be collected for serum, DNA, and peripheral blood mononuclear cells (PBMC).
16129186|NCT01940835|Other|Stool sample|Stool samples will be collected at baseline for future microbiome and virome studies.
16129187|NCT01940822|Other|Energy Drink|
16129188|NCT01940822|Other|Placebo Drink|
16129189|NCT01940809|Drug|Dabrafenib|Given PO
16129190|NCT01940809|Biological|Ipilimumab|Given IV
16129191|NCT01940809|Other|Laboratory Biomarker Analysis|Correlative studies
16129192|NCT01940809|Biological|Nivolumab|Given IV
16129193|NCT01940809|Drug|Trametinib|Given PO
16129194|NCT01940796|Drug|Brentuximab Vedotin|Up to five dose levels will be tested in cohorts of 3-6 participants each. Once the maximum tolerated dose (MTD) is established, 10 more participants will be treated at the MTD for analysis of efficacy.
16129195|NCT01940783|Radiation|Cone Beam Computed Tomography (CBCT)|Two postoperative CBCT scans, the first one on the day after cochlear implantation and the second after 3 months.
16129196|NCT01940783|Device|Magnetic Resonance Imaging (MRI)|One pre-operative (before cochlear implantation) MRI scan of the cochlea.
16129197|NCT01940757|Biological|Necator americanus Hookworm Larvae|Infectious larvae of the human hookworm Necator americanus
16129198|NCT01940744|Procedure|Prescriptive Mobilization|"The therapist will place the hypothenar eminence of 1 hand over the spinous process of L4. With the elbows remaining extended, the therapist will deliver a low-velocity, high amplitude oscillatory force (at approximately 2 Hz) directed at L4 for a total 60 seconds (Figure 1). Following a 30-second rest the therapist will perform a similar set of oscillations directed at L5. A second set of oscillations will then be performed in a similar manner at L4 and L5. Although not described in the original article, we'll target Grade III mobilizations. The procedure will be completed during a session after 2 sets of 60 seconds of non-thrust oscillatory manipulations will be performed over L4 and L5. Patients will be seen for 4 visits."
16129199|NCT01940744|Procedure|Pragmatic Mobilization|The techniques will of consist of passive, low velocity, oscillatory movements within the physiological range of the joint, applied to the comparable spinal level of the patient (defined as the spinal level that reproduced the patient's familiar pain). The techniques will be modified based on clinician assessment and patient feedback and consist of Grade I through Grade IV movements. Common techniques used may include unilateral posterior-anterior movements, central posterior-anterior movements, and sidelying rotations (without thrust). Since the pragmatic approach is clinician-driven, no time limit will be placed on the application and the number of mobilizations used will depend on the patient feedback (the exact definition of a pragmatic treatment). Patients will be seen for 4 visits.
16129200|NCT01940731|Drug|Colistimethate sodium|3-5mg/(kg.d)(if CLcr≥80 mL/min),The maximum dose≤300mg/d 2.5-3.8mg/(kg.d)（if CLcr=50-79mL/min），The maximum dose≤230mg/d twice a day
16129201|NCT01940718|Drug|Transdermal Androgel|T dosing will be initiated at the lowest possible level (20.25 mg testosterone = 1 pump actuation) which is expected to increase average serum T concentrations no higher than the mid-normal range (500-800 ng/dl), with respect to expected baseline measurements in our population (~300-500 ng/dl).The T dose will be adjusted two weeks after initiation of treatment based on the measurement of serum T levels. Dosing adjustments can be made at 20.25 mg testosterone increments. The medication will be taken transdermally once daily for 3.5 months.
16129202|NCT01940705|Other|Hearing-Aid Informational Guide|Printed take-home guide on hearing aids
16129203|NCT01940705|Other|Hearing-Aid DVD|Take-home DVD about hearing aids
16129204|NCT01940705|Behavioral|Teach-back Technique|Counseling/Educational session using the teach-back technique to review information about their hearing aids
16129205|NCT01940705|Other|Standard of Care|standard of care hearing-aid orientation as provided by clinical audiologist
16129206|NCT01940692|Drug|1.5g intravenous Exacyl|intravenous administration of 1.5g Exacyl preoperatively
16129207|NCT01940692|Drug|3.0g intra-articular Exacyl|3g Intra-articular Exacyl administration postoperatively
16129208|NCT01940679|Dietary Supplement|encapsulated 600 mg EPA/DHA|encapsulated 600 mg EPA/DHA
16129209|NCT01940653|Drug|Progesterone|"Procedures Transvaginal ultrasound (US) and hormone analysis for FSH, LH, E2 and P on day 2 of the cycle will be performed. The artificial preparation of the endometrium consists of 7 days oestradiol valerate (Progynova®, Bayer-Schering Pharma AG, Berlin, Germany) 2 mg bid (bi-daily), followed by 6 days oestradiol valerate 2 mg tid (thrice daily). On day 13, the endometrium is measured. If endometrial thickness is more than 7 mm, patients are randomly assigned to group A or B. All patients with an endometrium less than 7 mm on day 13 of estrogen stimulation, are excluded.
~Group A receives 5 days of micronized progesterone vaginally (Utrogestan® ((Utrogestan, Besins International), 3x200mg daily), group B receives 3 days of micronized progesterone vaginally. On the 5th (group A) or 3rd (group B) day of progesterone supplementation, the cryopreserved-thawed day 3 embryo is transferred."
16129210|NCT01940640|Dietary Supplement|DHA|We will establish two groups of premature newborn children (<34 weeks) (n=40) and one group of newborn children to term (n=40). The mothers of one of the groups of premature newborn children will receive an oral supplementation by means of capsules with high dose of DHA (900 mg/day) during the lactation (minimum period of 3 months).
16129211|NCT01940640|Dietary Supplement|control|We will establish two groups of premature newborn children (<34 weeks) (n=40) and one group of newborn children to term (n=40). The mothers of one of the groups of premature newborn children will receive an oral supplementation by means of capsules with high dose of DHA during the lactation (minimum period of 3 months).
16129212|NCT01940627|Dietary Supplement|Ubiquinol|Ubiquinol 200mg/day (two capsules of 100 mg (Breakfast and lunch)) for 14 days
16129213|NCT01940627|Dietary Supplement|Control|placebo capsules (two capsules (Breakfast and lunch)) for 14 days
16129214|NCT01940614|Other|Water deprivation test|Classical water deprivation test alone
16129215|NCT01940614|Other|Water deprivation test|classical water deprivation test plus plasma copeptin cut-off levels
16129216|NCT01940614|Other|Hypertonic saline infusion|hypertonic saline infusion test plus plasma copeptin measurement
16129217|NCT01940601|Drug|Balugrastim|Balugrastim 300 ug/kg and Balugrastim 670 ug/kg
16129218|NCT01940601|Drug|Filgrastim|Filgrastim 5 μg/kg
16129219|NCT01940588|Behavioral|Neuropsychoanalytic therapy|Psychotherapy, medication management
16129220|NCT01940575|Device|SkinPlus-Hyal®|The Injector will administer to the eligible subject the Study Device and Comparator Device (Comparator or Study Device) respectively to the left and right nasolabial fold in a randomized manner.
16129221|NCT01940575|Device|Restylane®|The Injector will administer to the eligible subject the Study Device and Comparator Device (Comparator or Study Device) respectively to the left and right nasolabial fold in a randomized manner.
16129222|NCT01940562|Drug|eltrombopag|"Children ≥= 40 kg BW:
~From day +1, start eltrombopag 100 mg/d. If primary end point not reached on day +14, then from day +15 - 150 mg/d. If primary end point not reached on day +28 then from day +29 - 200 mg/d (maximal dose).
~Children 20-40 kg BW:
~From day +1, start eltrombopag 50 mg/d. If primary end point not reached on day +14, then from day +15 - 75 mg/d. If primary end point not reached on day +28 then from day +29 - 100 mg/d.If primary end point not reached on day +42, then from day +43 and on - 150 mg/d (maximal dose).
~Children < 20 kg BW:
~From day +1, start eltrombopag - 2 mg/kg/d. If primary end point not reached on day +14, then from day +15 - 3 mg/kg/d. If primary end point not reached on day +28 then from day +29 - 3.5 mg/kg (maximal dose).
~If present dose not tolerated, return to last tolerated dose. Eltrombopag will be discontinued after platelet count has exceeded 50,000/microliter for 14 consecutive days without administration of platelets."
16129223|NCT01940549|Device|Trauma Focused Therapy + tDCS|
16129224|NCT01940536|Drug|Tranexamic Acid|antifibrinolytic
16129225|NCT01940536|Drug|Placebo|Placebo
16129226|NCT01940523|Drug|Topical Tranexamic Acid|3 vials of tranexamic acid (1g tranexamic acid in 10cc each) must be mixed in the operating room by the team at the start of surgery with 45cc of saline solution (for a total of 3g tranexamic acid in 75mL solution). This solution will be applied to the open joint surfaces with two 60mL syringes (one with 60mL and one with 15m). The solution will be left in contact with the tissues for five minutes. The surgeon will suction away excess solution. The site may be irrigated before or after the tranexamic acid bath as long as the solution is in contact for at least five full minutes. After that, the tourniquet will be released and the rest of the surgery will proceed according to the standard of care.
16129227|NCT01940523|Drug|Intravenous Tranexamic Acid|1 vial (1g of IV tranexamic acid in 10mL solution) will be administered prior to inflation of the tourniquet. A second 1g dose of IV tranexamic acid will be given during initiation of the closure after the tourniquet is deflated and during closure.
16129228|NCT01940510|Drug|RO5424802|Single dose without (Day 1) and with (Day 17) co-administration of rifampin
16129229|NCT01940510|Drug|rifampin|Multiple doses Days 8-16 and Days 17-20
16129230|NCT01940497|Drug|Doxorubicin|Participants will receive doxorubicin in doses according to the locally-approved regimen q3w (1 cycle), for 4 cycles prior to initiation of trastuzumab treatment.
16129231|NCT01940497|Drug|Docetaxel|Participants will receive docetaxel in doses according to the locally-approved regimen q3w for 12 weeks, in combination with trastuzumab.
16129232|NCT01940497|Drug|Paclitaxel|Participants will receive paclitaxel in doses according to the locally-approved regimen weekly for 12 weeks, in combination with trastuzumab.
16129233|NCT01940497|Drug|Trastuzumab|Participants will receive trastuzumab 600 mg SC (vial or SID) q3w for 18 cycles.
16129234|NCT01940484|Drug|Methoxy polyethylene glycol epoetin beta|
16129235|NCT01940471|Drug|TAF|25 mg tablet administered orally once daily
16129236|NCT01940471|Drug|TDF|300 mg tablet administered orally once daily
16129237|NCT01940471|Drug|TAF Placebo|Tablet administered orally once daily
16129238|NCT01940471|Drug|TDF Placebo|Tablet administered orally once daily
16129239|NCT01940445|Device|M22 ResurFX|Fractional NA treatment (ResurFX) on one side of the face
16129240|NCT01940445|Device|M22 ResurFX and QS|Fractional NA treatment followed by QS laser treatment (SST) on one side of the face
16129241|NCT01940432|Device|electroacupuncture group|Procedure: electro-acupuncture;Points: Bilateral Zhong Liao (BL33) Hui Yang(BL35).Specially-made pad is stick on pierced acupoints. Bilateral BL33 are given acupuncture of 50一60mm with 30一45°angle to inward and downward by 75mm filiform needle. Bilateral BL35 are given acupuncture of 50一60mm to outward and upward by 75mm filiform needle. Twirl, lift and thrust for 3 times, until local sour and heavy feeling coming.The electric stimulator is applied to bilateral BL33 and BL35, with dilatational wave,50 Hz and electric current 1一5mA(milliampere).Every session lasts for 30 min per day.The participants are treated continuously for 8 weeks for 3 sessions a week, 24 sessions for each patient in all. The treatment is designed based on recent literature research in 10 years, former result and expert consensus.
16129242|NCT01940432|Behavioral|pelvic floor muscle training group|Procedure:first,identify anal sphincter/feel anus, and try to raise it from chair (without adding abdominal, thigh, and buttock muscles) with a position of sitting; second, identify levator ani and try to raise vagina from chair (without adding abdominal, thigh, and buttock muscles) with a position of Sitting, bent forward, elbows on knees; third, contract levator ani with a position of sitting, lying, and standing; fourth, contract anal sphincter with a position of sitting, lying, and standing. Length of Treatment and the treatment sessions are the same as treatment group.
16129243|NCT01940419|Drug|Tranexamic Acid|1g Tranexamic acid iv administered over 10 minutes just before surgery
16129244|NCT01940419|Drug|Placebo|10 ml sodium chloride iv administered over 10 minutes just before surgery
16129245|NCT01940406|Procedure|Stimulation procedure|Device
16129246|NCT01940393|Drug|Cetirizine|Drug administration
16129247|NCT01940393|Drug|Desloratadine|Drug Administration
16129248|NCT01940393|Drug|Fexofenadine|Drug administration
16129249|NCT01940393|Drug|Ebastine|Drug administration
16129250|NCT01940393|Drug|Bilastine|Drug administration
16129251|NCT01940367|Device|PTNS (Percutaneous Tibial Nerve Stimulation|PTNS therapy is performed as follows; the subject sits in a frog leg position in a chair. The area where the needle will be placed is cleaned with an alcohol swab. A 34 gauge needle (equivalent to an acupuncture needle) is inserted percutaneously approximately 5 cm cephalad to the medial malleolus of the right or left ankle (subject choice) at a 60 degree angle. A surface electrode is placed on the medial aspect of the ipsilateral calcaneous. The needle and electrode are connected to a low voltage (9 V) electrical stimulator (Urgent PC). Stimulation current with a fixed frequency of 20 Hz and a pulse width of 200 msec is increased until flexion of the big toe or fanning of all toes becomes visible, or until the subject reports a tingling sensation across the heel or bottom of the foot. The current is then set to the highest level tolerable to the subject (0-10 mA) and the subject undergoes therapy for 30 minutes.
16129252|NCT01940367|Device|TENS (Transcutaneous Electrical Nerve Stimulation)|"TENS therapy will be administered as follows:
~Surface electrodes, 2 x 2 in diameter, will be placed over sacral foramen S2-4, bilaterally, using 2 channels (4 electrodes total) - Approximate locations are over posterior superior iliac spine and inferior lateral angle of sacrum. Sticker electrodes for the duration of the study will be issued to subjects. They are adhesive and can be re-used for up to 3-4 weeks with proper skin care and electrode care.
~The electrodes will be connected to the TENS (Transcutaneous Electrical Nerve Stimulation) device and the following settings will be pre-set:
~Mode: Burst
~Cycle: 10 seconds
~Frequency: 10 Hz
~Pulse Width: 250 µs
~Intensity: to subject comfort level"
16129253|NCT01940354|Device|AccuCath IV Catheter System|Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.
16129254|NCT01940354|Device|Conventional IV Catheter System|Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples
16129255|NCT01940341|Drug|TAF|25 mg tablet administered orally once daily
16129256|NCT01940341|Drug|TDF|300 mg tablet administered orally once daily
16129257|NCT01940341|Drug|TAF Placebo|Tablet administered orally once daily
16129258|NCT01940341|Drug|TDF Placebo|Tablet administered orally once daily
16129259|NCT01940328|Device|Transchoracic ultrasound Doppler|
16129260|NCT01940315|Biological|rBV A/B|0.5 mL dose of rBV A/B (40 µg) given at Days 0, 28 ± 5 days, and 182 ± 9 days
16129261|NCT01940315|Biological|Placebo (USP sterile saline for injection)|0.5 mL dose of Placebo will be given at Days 0, 28 ± 5 days, and 182 ± 9 days
16129262|NCT01940302|Dietary Supplement|LEHEL multi-nutrients supplement|The primary objective of this study is to evaluate the effect of a diet program including LEHEL multi-nutrients supplement as breakfast replacement on metabolic control after 12-week intervention in subjects with type 2 diabetes.
16129263|NCT01940289|Device|Algometric meter readings for perception of pain|
16129264|NCT01940276|Drug|Abiraterone acetate|
16129265|NCT01940276|Drug|Prednisone|
16129268|NCT01940250|Drug|Magnesium Sulphate|MgSO4 IV infusion
16129269|NCT01940250|Drug|Sterile water|H2O IV infusion
16129270|NCT01940237|Behavioral|Psychotherapy|Interpersonal psychotherapy in the treatment of major depressive disorder.
16129271|NCT01940224|Drug|Pregabalin|Preoperative administration of pregabalin 300mg
16129272|NCT01940224|Drug|Placebo|Preoperative administration of placebo
16129273|NCT01940224|Drug|Morphine|Postoperative administration of morphine via PCA pump for 48h
16129274|NCT01940185|Device|LINX device|
16129275|NCT01940172|Drug|Birinapant|"Dose Escalation:
~Dose Level (1) - 13 mg/m2 (twice a week for 3 of 4 weeks); Dose Level (-1) - 11 mg/m2 (twice a week for 3 of 4 weeks); Dose Level (2) - 13 mg/m2 (twice weekly for 4 weeks );"
16129276|NCT01940172|Drug|Conatumumab|10 mg/kg IV on Day 1 and 15 of each cycle
16129277|NCT01940159|Drug|SEP-363856|SEP-36385625 as a single oral dose of 25, 50, 100, and 150 mcg
16129278|NCT01940159|Drug|Placebo|single oral dose placebo
16129279|NCT01940146|Drug|SPARC Placebo|Placebo
16129280|NCT01940146|Drug|SPARC1310 I|SPARC1310 I
16129281|NCT01940146|Drug|SPARC1310 II|SPARC1310 II
16129282|NCT01940146|Drug|SPARC1310 III|SPARC1310 III
16129283|NCT01940133|Drug|PQR309|Dosing will be orally, once a day for the duration of the trial.
16129284|NCT01940120|Device|Percutaneous mitral valve repair using MitraClip implant|Procedure/Surgery: Mitral valve repair or replacement surgery Repair or replacement of mitral valve
16129285|NCT01940107|Other|evaluations|Only evaluations
16129286|NCT01940107|Procedure|Protocol of physiotherapy exercises|Oriented domiciliary physiotherapeutic exercises
16129287|NCT01940094|Drug|5 mg Prednisone|Subjects will remain on daily prednisone dose of 5 mg
16129288|NCT01940094|Drug|0 mg Prednisone|Subjects will taper their prednisone dose from 5 mg per day to 0 mg per day
16129289|NCT01940081|Other|Transthoracic echocardiography|
16129290|NCT01940081|Other|Exercise test|
16129291|NCT01940081|Other|24-hour Holter electrocardiogram|
16129292|NCT01940081|Other|Contrast-enhanced magnetic resonance imaging|
16129293|NCT01940081|Other|123-iodine metaiodobenzylguanidine imaging|
16129294|NCT01940081|Other|Blood samples|
16129295|NCT01940081|Genetic|Genetic analysis|
16129296|NCT01940081|Procedure|Invasive electrophysiological study|
16129297|NCT01940081|Procedure|Endomyocardial biopsy|
16129298|NCT01940081|Procedure|Intraoperative biopsy|
16129299|NCT01940081|Procedure|Intraoperative mapping and/or ablation|
16129300|NCT01940068|Dietary Supplement|Amino acid based formula|
16129301|NCT01940055|Behavioral|Dual task treadmill walking exercise program|Participants will receive 5 minute warm up and cool down session followed by a 30 minute dual task program which includes treadmill walking while playing brain fitness or cognitive games. Rest periods will be provides to the participants. Treadmill speed will be set so as to not exceed 60% of maximum heart rate. Heart rate and perceived excretion( per the Borg 1-10) will be measured at 5 minutes of interval.
16129302|NCT01940055|Behavioral|Dual task recumbent cycling exercise program|Participants will receive a 5 minute warm up and cool down session followed by a 30 minute dual task exercise program which includes recumbent cycling while playing brain fitness or cognitive games. Rest periods will be provides to the participants. Recumbent cycling speed will be set so as to achieve 60% of maximum heart rate. Heart rate and perceived excretion( per the Borg 1-10) will be measured at 5 minutes of interval.
16129303|NCT01940042|Behavioral|CO2 was removed by means of trandelenburg positions|
16129304|NCT01940016|Behavioral|communication intervention|Participants participate in a 12-week physical activity intervention (walking program)and receive health mail messages via IVR system and had the option of communicating with a health coach.
16129305|NCT01940016|Behavioral|exercise intervention|Participants participate in a 12-week physical activity intervention administered using an IVR system.
16129306|NCT01940003|Other|Aquatic exercise|The aquatic exercise program will be under the professional guidance of a physiotherapist, with water at a temperature of around 26 to 28°C. The exercise sessions will be executed following the steps: 1) Heating (stretching and flexibility, static method, during 5'); 2) Aerobic exercise (running, displacements and combined movements of arms and legs, with 1minute interval, to 1minute activity and of during 20') 3) Spot exercises (strength / endurance of the upper and lower limbs and abdomen, using the resistance of water for 15') 4) Relaxation (slow walks for 5'). During the sessions of exercises the pregnant women will have heart rate monitored by the frequency meter (Polar Electro OY) to control the intensity of the exercises that will focus on the range of moderate intensity.
16129307|NCT01939990|Drug|Placebo|The placebo looks like the study drug but it does not contain active ingredients.
16129308|NCT01939990|Drug|Nebivolol|5 to 10mg per day
16129309|NCT01939977|Drug|Paricalcitol|1 capsule/day for 6 months. On Month 1 and Month 3 it can be increased up to 2 capsules/day or decreased down to 1 capsule/48 hours.
16129310|NCT01939977|Drug|Calcifediol|5 drops/day during 6 months. On Month 1 it can be increased up to 7 drops/day. If this occurs then, on Month 3, it can decreased to 5 drops/day or continue 7 drops/day until end of treatment.
16129311|NCT01939964|Other|Activation Mist|Activation Mist topical spray
16129312|NCT01939951|Dietary Supplement|Activation Energy Serum|7 drops or 21 drops twice daily
16129313|NCT01939938|Device|Nasal and Oronasal PAP Mask|Subjects will be imaged via MRI wearing a nasal and oronasal PAP mask at 5, 10 and 15 cm H20.
16129314|NCT01939925|Other|New plain language summary format|New plain language summary includes qualitative and quantitative description of text (absolute effects and natural frequencies provided); quantitative results provided in a table; quality of the evidence according to GRADE provided in a table; question and answer format; follows principles of linguistic frameworks (e.g. progressive movements from introduction to 'bottom line')
16129315|NCT01939925|Other|Current plain language summary format|Current plain language summary includes qualitative description of effects only; inconsistent description of the quality of the evidence; paragraph of text; inconsistent flow of information
16129316|NCT01939912|Drug|Adenosine|Antiarrhythmic agent.
16129317|NCT01939899|Drug|IXAZOMIB|Each 28-day treatment cycle will include oral administration of IXAZOMIB on Days 1, 8, and 15 followed by a rest period of 13 days.
16129318|NCT01939886|Drug|Mefloquine - Artesunate|
16129319|NCT01939886|Drug|Artemether-lumefantrine combination|
16129320|NCT01939873|Behavioral|KRISTELLER|
16129321|NCT01939860|Other|Written and verbal patient education on hypertension and its treatment|
16129322|NCT01939847|Other|Treatment suggestion|Based on any actionable findings of the molecular profiling results, the investigators will come up with a suggestion for approved treatment or for clinical trial by referencing institutional clinical trials or potentially nationwide possibilities (www.clinicaltrials.gov).
16129323|NCT01939834|Device|AAA control|"AAA control is a method to determine insulin dosing to keep glucose in range. AAA control is run on the DiAs which is a medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump. The cell phone runs the AAA control and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range.
~AAA control will be tested in 40 hours sessions and 5 consecutive overnight sessions."
16129324|NCT01939834|Other|CGM + insulin pump at home|The subject will be on their home insulin pump and using a CGM per their usual care.
16129325|NCT01939821|Behavioral|Educational and counselling program|"Educational and counselling program: In addition to educational meeting and printed educational material the investigators will include the use of local opinion leaders and educational outreach . Local opinion leaders are defined as use of providers nominated by their colleges as educationally influential. Opinion leadership is the degree to which an individual is able to influence other individual's attitudes or overt behavior informally in a desired way with relative frequency. Educational outreach is defined as use of a trained person who meets with providers in their practice setting to give information with the intent of changing the providers practice."
16129326|NCT01939821|Behavioral|Educational program|"Educational program: Educational meeting and printed educational material Educational meeting is defined as participation of healthcare providers in conference, lectures, workshops or traineeships. The investigators want to organize the educational meetings as an interactive workshop that target knowledge, attitudes, and skills at the individual healthcare professional/peer group level. Printed educational material is defined as distribution of published or printed recommendations for clinical care, including clinical practice guidelines. In general, printed educational material target knowledge and potential skill gaps of individual healthcare professionals."
16129327|NCT01939808|Other|Splint Neutral|
16129328|NCT01939808|Other|Splint Extended|
16129329|NCT01939795|Other|exercise training and/or CRT|Three 40-minute exercise sessions per week on a treadmill for four months
16129330|NCT01939782|Other|No Breakfast (NoB)|In both occasions the blood samples for glucose and insulin, cortisol triglycerides and intact GLP-1 will be taken after overnight fast at 8:30 and thenat 8:30, 9:00, 10:30, 12:00, 12:30, 14:00 and 15:30. The samples for clock genes and for DPP4 plasma activity will be taken at 8:30, 12:00 (before lunch) and at 15:30 (3 1/2 h after lunch).
16129331|NCT01939782|Other|Yes Breakfast (YesB)|In both occasions the blood samples for glucose and insulin, cortisol, triglycerides and intact GLP-1 will be taken after overnight fast at 8:30 and then at 8:30, 9:00, 10:30, 12:00, 12:30, 14:00 and 15:30. The samples for clock genes and for DPP4 plasma activity will be taken at 8:30, 12:00 (before lunch) and at 15:30 (3 1/2 h after lunch).
16129332|NCT01939769|Other|Exercise - Low-intensity exercise|
16129333|NCT01939769|Other|Exercise - High-intensity exercise|
16129334|NCT01939756|Device|Intravesical baobab oil|Intravesical baobab oil
16129335|NCT01939743|Drug|Diclofenac suppository plus lidocaine gel|
16129336|NCT01939743|Drug|Lidocaine gel only|
16129337|NCT01939730|Drug|Rituximab|375 mg/m^2 by vein once a week for 4 weeks on Days 1, 8, 15, 22.
16129338|NCT01939730|Drug|GM-CSF|250 mcg subcutaneously 3 times a week for 8 weeks.
16129339|NCT01939717|Other|Dance group|"Participants will attend ten weeks of set dancing classes. Each class will be one and half hours. Family members will be invited to partner each participant with Parkinson's disease during the class. Set dancing steps and sets will be thought and progressed in line with the participants abilities. Frequent rests will be taken during the classes.
~Participants will be given a home exercise programme which will involve chair based exercises, mental rehearsal, listening music, watching a dance DVD and practicing dance material thought in class."
16129340|NCT01939704|Other|Pediatric Primary Care Intervention|30 minute on-site intervention with biweekly follow up phone calls to address social needs and health care status.
16129341|NCT01939704|Other|Pediatric Urgent Care Intervention|3 months of intervention protocol, including a 30 minute on-site intervention and twice monthly phone calls to address social needs and health care status.
16129342|NCT01939691|Drug|Difluprednate|Difluprednate 0.05% - corticosteroid eyedrop
16129343|NCT01939691|Drug|Nepafenac|Nepafenac 0.1% - NSAID eyedrop
16129344|NCT01939691|Drug|Prednisolone acetate|prednisolone acetate 1% - corticosteroid eyedrop
16129345|NCT01939665|Device|"NanoKnife Irreversible electroporation (IRE)"|Tumor ablation with irreversible electroporation with the NanoKnife
16129346|NCT01939652|Procedure|Restrictive VS Standard Fluid Regime|
16129347|NCT01939652|Drug|Drag: Crystalloids and Colloids|
16129348|NCT01939639|Drug|Placebo|intranasal application, sodium chloride solution, 3 puffs per nostril
16129349|NCT01939639|Drug|Oxytocin|24 IU Oxytocin, intranasal application 45 min prior to the experiment
16129350|NCT01939626|Device|Single-step medium|This medium will allow in vitro culture of human embryos for 5/6 days
16129351|NCT01939626|Device|Standard culture medium|This culture system needs media change on day 3 of culture.
16129352|NCT01939613|Drug|colloids|TMMU group allows for administration of colloids early,while Parkland group infuse colloids 24 h after burn injury.
16129353|NCT01939600|Other|Starch-free breakfast|Starch-free breakfast alone
16129354|NCT01939600|Other|Hi-Maize 260|Starch-free breakfast plus 55.3g Hi-Maize 260
16129355|NCT01939600|Other|Hylon VII|Starch-free breakfast plus 56.9g Hylon VII
16129356|NCT01939600|Other|Amioca|Starch-free breakfast plus 56.4g amioca starch
16129357|NCT01939587|Drug|PBF-680 5 mg|
16129358|NCT01939587|Drug|PBF-680 20 mg|
16129359|NCT01939587|Drug|Placebo|
16129443|NCT01939028|Procedure|lymphadenectomy|Undergo para-aortic lymphadenectomy
16129445|NCT01939015|Device|Standard titanium miniplate- single non compression miniplate|single non compression miniplate placed at superior border with monocortical screws via intraoral approach
16129446|NCT01939002|Drug|BIIB017|
16129360|NCT01939574|Other|Chemoradiation Therapy|"Radiation therapy:For both intensity-modulated radiation therapy (IMRT) and three-dimensional conformal radiation therapy (3D-CRT) plans, one treatment of 2 Gy will be given daily 5 days per week for a total of 60 Gy over 6 weeks.
~Temozolomide will be administered continuously from day 1 of radiotherapy to the last day of radiation at a daily oral dose of 75 mg/m2 for a maximum of 49 days.
~Bevacizumab will be administered intravenously on days 1 and 15 of each 28-day cycle,at the beginning of the 4th week of radiation. The dose will be 10 mg/kg of actual body weight."
16129361|NCT01939574|Other|Adjuvant Therapy|"Temozolomide will be administered orally once per day for 5 consecutive days (days 1-5) of a 28-day cycle. The starting dose for the first cycle will be 150 mg/m2/day, with a single dose escalation to 200 mg/m2/day in subsequent cycles if no treatment-related adverse events> grade 2 are noted.
~Bevacizumab will be administered intravenously on days 1 and 15 of each 28-day cycle. The dose will be 10 mg/kg of actual body weight."
16129362|NCT01939561|Drug|Lamotrigine|
16129363|NCT01939561|Drug|Placebo|Placebo is tablets identically with the Lamotrigine tablets.
16129364|NCT01939548|Drug|PF-02545920|PF-02545920 2 mg BID x 7 days, then 5 mg BID until the Week 12 visit
16129365|NCT01939548|Drug|Placebo|Placebo BID until the Week 12 visit
16129366|NCT01939548|Drug|PF-02545920|PF-02545920 5 mg BID x 7 days, then 10 mg BID x 7 days, then 15 mg BID until the Week 12 visit
16129367|NCT01939535|Other|No intervention|Evaluation of an imaging technique ic MRI
16129368|NCT01939522|Biological|13-valent pneumococcal conjugate vaccine (PCV13)|
16129369|NCT01939509|Drug|Atenolol|Crossover (atenolol 25-50 mg, bisoprolol 2.5-5 mg)
16129370|NCT01939509|Drug|Bisoprolol|
16129371|NCT01939496|Drug|Canagliflozin|One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) in addition to the patient's anti-hyperglycemic agents (AHA) regimen used in accordance with local prescribing information.
16129372|NCT01939496|Drug|Placebo|One matching placebo capsule orally in addition to the patient's anti-hyperglycemic agents (AHA) regimen used in accordance with local prescribing information.
16129373|NCT01939483|Drug|irinotecan hydrochloride|Given IV
16129374|NCT01939483|Other|laboratory biomarker analysis|Correlative studies
16129375|NCT01939457|Drug|Misoprostol|
16129376|NCT01939444|Drug|naloxone intranasal|If bioavailability is 20% or 50 %, the dose will be equivalent to the clinical range 0.4 - 1.0 mg given parenterally
16129377|NCT01939444|Drug|naloxone intravenous|The parenteral dose reflects clinically used doses for overdoses (0.4 - 1.0 mg). A washout period of at least 3 days between each intervention. IV naloxone (Naloxone B. Braun 0.4mg/ml) administered slowly over 1-2 min in the recumbent position
16129378|NCT01939418|Drug|RAD001|Afinitor 5mg qd. po.
16129379|NCT01939418|Drug|Gemcitabine|gemcitabine 800mg/m2 iv. D1 and D8 every 3 weeks
16129380|NCT01939418|Drug|Cisplatin|cisplatin 30mg/m2 iv. D1 and D8 every 3 weeks
16129381|NCT01939405|Behavioral|built environment use counseling|
16129382|NCT01939392|Device|Renal Denervation (OneShot™ Renal Denervation System)|
16129383|NCT01939379|Drug|Morphine PCA started at the end of surgery, 1 Percocet 1/325mg every 4 hours; may receive a second Percocet if needed.|
16129384|NCT01939379|Drug|For the 30ml ropivacaine the intervention would be the subject can request extra pain medication which would be Percocet and/or morphine PCA.|
16129385|NCT01939366|Drug|Cebranopadol 100 µg|Participants randomized to 100 μg cebranopadol will start with 100 μg per day and will remain on 100 µg per day.
16129386|NCT01939366|Drug|Cebranopadol 300 µg|Participants randomized to 300 μg cebranopadol will start with 100 μg per day and increase to 300 µg per day on day 4 and will remain on 300 µg per day.
16129387|NCT01939366|Drug|Cebranopadol 600 µg|Participants randomized to 600 μg cebranopadol will start with 200 μg per day and increase to 400 µg per day on day 4 and to 600 µg on day 7, thereafter they will remain on 600 µg per day.
16129388|NCT01939366|Drug|Pregabalin|Stepwise titration from 75 mg twice a day to 300 mg twice a day over 2 weeks.
16129389|NCT01939366|Drug|Matching Placebo|Placebo will be matched to pregabalin and cebranopadol.
16129392|NCT01939327|Drug|Lenalidomide/Rituximab|
16129393|NCT01939314|Drug|Bupivacaine|Bupivavaine Delivered by the Tx 360 Device to the Sphenopalatine Ganglion
16129394|NCT01939314|Drug|Placebo|Normal Saline Delivered by the Tx 360 Device to the Sphenopalatine Ganglion
16129395|NCT01939301|Drug|Inhaled Nitric Oxide|Nitric Oxide + oxygen
16129396|NCT01939301|Drug|Sham|Nitrogen + Oxygen
16129397|NCT01939288|Device|Neuromuscular stimulation, followed by intermittent pneumatic compression|
16129398|NCT01939288|Device|Intermittent pneumatic compression, followed by neuromuscular stimulation|
16129399|NCT01939275|Radiation|copper Cu 64-DOTA-trastuzumab|Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan
16129400|NCT01939275|Device|positron emission tomography|Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan
16129401|NCT01939275|Other|laboratory biomarker analysis|Correlative studies
16129402|NCT01939275|Procedure|Computed Tomography|Undergo Copper Cu 64-DOTA-trastuzumab PET/CT scan
16129403|NCT01939262|Other|Limitation of Animal Fat and Protein in the Diet|Animal products were proscribed and the use of unrefined foods was encouraged. Participants were asked to limit high-fat plant foods, such as nuts, avocados, and refined oils. There was no restriction in energy intake, were encouraged to eat freely and not count calories.
16129404|NCT01939262|Other|Control|Participants assigned to the control group will be instructed to follow their usual diets.
16129405|NCT01939249|Device|Abbott Laboratories Xience|
16129406|NCT01939249|Device|Biotronik Orsiro|
16129407|NCT01939236|Drug|traditional Chinese medicine|1 bag of drug 2 times per day for 28 days according to syndrome differentiation. For example, the syndrome of one patient is qi deficiency and blood stasis, he will take drugs of qi deficiency and blood stasis each bag 2 times per day for 28days.
16129444|NCT01939015|Device|3D titanium miniplate|for study group by using 3D titanium miniplate under open reduction under general anesthesia with mono cortical screw, while in control group single titanium miniplate at superior border with mono cortical screw according to ideal line of osteosynthesis of champy
16129447|NCT01939002|Drug|naproxen|
16129408|NCT01939236|Drug|Placebo (gummeline)|"Placebo of each syndrome differentiation has the same weight and smell as traditional Chinese medicine of corresponding syndrome differentiation.
~1 bag of drug 2 times per day for 28 days according to syndrome differentiation.
~For example, the syndrome of one patient is qi deficiency and blood stasis, he will take drugs of qi deficiency and blood stasis each bag 2 times per day for 28 days."
16129409|NCT01939223|Drug|Regorafenib (Stivarga, BAY73-4506)|Four tablets of 40mg taken orally daily in the morning, dose of 160 mg for 21 days of treatment followed by 7 days without treatment
16129410|NCT01939223|Drug|Placebo|Four tablets taken in the morning orally daily for 21 days of treatment followed by 7 days without treatment
16129411|NCT01939210|Other|Educational Intervention|Participate in breathing training sessions
16129412|NCT01939210|Other|Meditation Therapy|Participate in breathing training sessions
16129413|NCT01939210|Other|Questionnaire Administration|Ancillary studies
16129414|NCT01939197|Drug|ABT-450/r/ABT-267|tablet
16129415|NCT01939197|Drug|ABT-333|tablet
16129416|NCT01939197|Drug|ribavirin|tablet
16129417|NCT01939184|Drug|WC3055|12.5, 25, 50 or 75 mg dose
16129418|NCT01939184|Other|Placebo|Placebo
16129419|NCT01939171|Drug|Thymoglobulin|
16129420|NCT01939158|Biological|Meningococcal vaccine GSK134612|1 or 2 doses administered intramuscularly in the left anterolateral thigh or deltoid region
16129421|NCT01939158|Biological|Prevenar 13™|1 dose administered intramuscularly in the right anterolateral thigh or deltoid region
16129422|NCT01939145|Drug|Normal saline|Normal saline (0.9% NaCl) is an isotonic solution that is widely used for intravenous application but is also used as our SOC for wound irrigation. This solution has high tolerability. Normal saline has been used as the instillation solution for NPWTi. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies
16129423|NCT01939145|Device|Prontosan|Prontosan (B Braun, Bethlehem, PA) is 0.1% polyhexanide, 0.1% betaine, sodium hydroxide, and purified water. The polyhexanide is an antiseptic and betaine is a surfactant. This solution is an FDA approved device indicated for topical irrigation. This solution has high tolerability with robust antimicrobial activity. Polyhexanide has been utilized as the instillation solution for NPWTi with positive clinical results. Prontosan is currently being used as the instillation solution for NPWTi in this facility as the SOC. The dwell setting for this solution is 20 minutes. The volume of solution to be used is dependent on the size of the wound hence varies.
16129424|NCT01939132|Drug|Open label H.P. Acthar Gel|Open-label H.P. Acthar Gel 80 units given subcutaneously twice weekly for 12 weeks with 12 week extension.
16129425|NCT01939106|Device|One Piece Drainable Pouch|
16129426|NCT01939093|Drug|Diazepam|If subjects had aggressive or violent symptoms and immediate symptom control was needed, 10 mg of diazepam (intravenous injection) every 4 hours is allowed for symptom control.
16129427|NCT01939093|Dietary Supplement|Vitamin B1-6-12|All subjects will be given the Institute's medication regimen, including vitamin B1-6-12 1 tablet three times a day after meals during the whole study period.
16129428|NCT01939093|Drug|Stugeron|All subjects will be given the Institute's medication regimen, including stugeron 1 tablet three times a day after meals during the whole study period.
16129429|NCT01939080|Procedure|Exercise training with supervised sessions|
16129430|NCT01939067|Device|Heated Humidified High Flow Nasal Cannula|Biweekly measurement of lung mechanics (dynamic compliance, airway resistance, work of breathing) and chest wall asynchrony measures while on HHHFNC and weekly when weaned off until 40 weeks post conceptional age or discharge. Recording of the level and the type of respiratory support and all cross over respiratory support devices. Recording of all growth parameters, neonatal morbidities and therapies.
16129431|NCT01939067|Device|Nasal Continuous Positive Airway Pressure|Biweekly measurement of lung mechanics (dynamic compliance, airway resistance, work of breathing) and chest wall asynchrony measures while on NCPAP and weekly when weaned off until 40 weeks post conceptional age or discharge. Recording of the level and the type of respiratory support and all cross over respiratory support devices. Recording of all growth parameters, neonatal morbidities and therapies.
16129432|NCT01939054|Drug|Nimotuzumab|
16129433|NCT01939054|Drug|docetaxel|
16129434|NCT01939054|Drug|capecitabine|
16129435|NCT01939041|Device|InMotion3 (IMT)|Participant will practice about 2-5-minute of passive, 25-30-minute of assisted-active, and 3-5-minute of active motions in wrist and forearm respectively. The wrist motions will include flexion, extension, radial deviation, and ulnar deviation. Forearm motions will include supination and pronation. During the practice, a visual display will provide online visual feedback of accuracy and coordination success.
16129436|NCT01939041|Device|Bi-Manu-Track (BMT)|The Bi-Manu-Track enables the symmetrical practice of 2 movement patterns in conjunction with computer games: forearm pronation-supination and wrist flexion-extension. Each movement has three computer-controlled modes: (1) passive-passive, with both arms being moved by the machine with speed and range of motion individually adjustable; (2) active-passive, with the nonaffected arm driving the affected arm in a mirror-like fashion; and (3) active-active, with both arms actively moving against resistance. The speed of movement, the amount of resistance, and the range of movement can be adjusted individually. The device has a mechanical breaking of the movement when the torques exceeded 4 Nm, emergency breaks in the reach of the patients, skin friendly materials, and minimal risk for contusions.
16129437|NCT01939041|Behavioral|Control intervention (CI)|he control group's therapy will be designed to control for the duration and intensity of the robot-assisted training (90 min/day, 5 days/wk, for 4 wk). The therapeutic activities in the control group will involve passive range of motion, weight bearing, stretching, strengthening of the paretic arm, gross motor activities, coordination tasks, unilateral and bilateral fine motor tasks, transition, mobility, and posture/balance.
16129438|NCT01939028|Procedure|lymph node mapping|Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution
16129439|NCT01939028|Procedure|sentinel lymph node biopsy|Undergo SLN biopsy
16129440|NCT01939028|Drug|isosulfan blue|Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution
16129441|NCT01939028|Drug|indocyanine green solution|Undergo lymph node mapping using isosulfan blue and/or indocyanine green solution
16129442|NCT01939028|Procedure|therapeutic conventional surgery|Undergo hysterectomy, bilateral salpingo-oophorectomy and/or complete pelvic lymphadenectomy
16129448|NCT01938989|Device|Clear clip-on glasses|Clip-on glasses with no light filtering properties
16129449|NCT01938989|Device|Blue light filter clip-on glasses|Clip-on glasses with blue light filtering properties equivalent to AcrySof IOLs
16129450|NCT01938976|Behavioral|TAJ Plus (Adolescent Asthma Action in Jordan) Plus the added class smoke free pledge|Its is a school-based peer-led asthma and smoking prevention program that aims at improving asthma control and lowering nicotine dependence among smokers.
16129451|NCT01938963|Behavioral|Collaborations in Health (COACH)|Primary care provider, aging worker, and Psychiatrist Consultant are trained to collaborate in their shared clients' care.
16129452|NCT01938950|Other|Aerobic Exercise|
16129453|NCT01938950|Other|Resistance Exercise|
16129454|NCT01938950|Other|Aerobic and Resistance Exercise|
16129455|NCT01938937|Device|Transcranial bright light device|
16129456|NCT01938937|Device|Transcranial sham device|
16129457|NCT01938924|Device|GekoTM|electrical neuromuscular stimulation
16129458|NCT01938911|Drug|Syntocinon-Spray|Intranasal oxytocin (24 IU)
16129459|NCT01938911|Drug|Placebo of syntocinon|Intranasal administration
16129460|NCT01938911|Behavioral|Social support|Social support from the best friend
16129461|NCT01938898|Other|Invitation letter randomisation|"There are 12 versions of the invitation letter. Three aspects of the letter will be adapted: (1) Gender of the signatory i.e. male, female or gender neutral (signed from the NICOLA team) (2) Description of NICOLA as a 'study' or 'project' and (3) Inserting a sentence guaranteeing the participants confidentially or not having this in the letter (but will still appear in the Patient Information Sheet). The twelve versions are as follows:
~Male & Study & Confidentiality
~Male & Study
~Male & Project & Confidentiality
~Male & Project
~Female & Project & Confidentiality
~Female & Project
~Female & Study & Confidentiality
~Female & Study
~Neutral & Study & Confidentiality
~Neutral & Study
~Neutral & Project & Confidentiality
~Neutral & Project"
16129462|NCT01938872|Procedure|paclitaxel eluting balloon angioplasty in below-the-knee lesions|
16129463|NCT01938859|Drug|Lithium|Lithium plasma concentration was between 0.6-1.2 mmol/L, dose should be fixed at the end of week 4, and the maximum dosage was judged by the investigator based on the patients' tolerability.
16129464|NCT01938859|Drug|Quetiapine|Quetiapine adjunctively to lithium therapy, target 400 mg/d with a minimum dose of 200 mg/d. Dose should be fixed at the end of week 4, and the maximum dosage was judged by the investigator based on the patients' tolerability.
16129465|NCT01938859|Drug|Shuganjieyu capsule|Shuganjieyu capsule adjunctively to lithium therapy, target dose 1440 mg/d.
16129466|NCT01938846|Drug|BI 860585|BI 860585 multiple dose escalation, once daily
16129467|NCT01938846|Drug|exemestane|exemestane once daily
16129468|NCT01938846|Drug|BI 860585|BI 860585 multiple dose escalation, once daily
16129469|NCT01938846|Drug|BI 860585|BI 860585 multiple dose escalation, once daily
16129470|NCT01938846|Drug|paclitaxel|paclitaxel once weekly
16129471|NCT01938833|Drug|Romidepsin|
16129472|NCT01938833|Drug|Abraxane|
16129473|NCT01938820|Drug|entecavir|anti-viral therapy
16129474|NCT01938820|Drug|Thymosin-α|antiviral and antifibrosis therapy
16129475|NCT01938807|Behavioral|CareCoach mobile application to assist in diabetes management|
16129476|NCT01938781|Drug|entecavir|antiviral therapy
16129477|NCT01938781|Drug|Peg-IFN|antiviral and antifibrosis therapy
16129478|NCT01938755|Drug|levobupivacaine|levobupivacaine plus 60 mg dextrose
16129479|NCT01938755|Drug|levobupivacaine|levobupivacaine plus 80 mg dextrose
16129480|NCT01938755|Drug|levobupivacaine|levobupivacaine plus 100 mg dextrose
16129481|NCT01938742|Biological|Influenza Virus Vaccine, Monovalent A/H7N9 A/Shanghai/2/2013|Monovalent influenza A/H7N9 virus vaccine for intramuscular use is a sterile, clear and slightly opalescent suspension. sanofi A/H7N9 antigen. Group 1 receives 3.75mcg A/H7N9 IM on days 1 and 21, Group 2 receives 7.5 mcg IM on days 1 and 21, Group 3, 4, 5, & 6 receives 15 mcg IM on days 1 and 21, and Group 7 receives 45 mcg IM on days 1 and 21.
16129482|NCT01938742|Drug|MF59|MF59 adjuvant is an oil-in-water emulsion composed of a small amount of squalene administered with different dosages. Group 1, 2 & 3 receives 0.7 ml of MF59 Intramuscularly (IM) on days 0 and 21. Group 4 receives MF59 on day 0, Group 5 receives MF59 on Day 21.
16129483|NCT01938729|Procedure|Liver resection and placement of hepatic artery infusion pump|
16129484|NCT01938729|Drug|FLOXURIDINE|
16129485|NCT01938729|Drug|DEXAMETHASONE|
16129486|NCT01938729|Drug|GEMCITABINE|
16129487|NCT01938716|Drug|Gemcitabine|500 mg/m2 at a fixed dose rate of 10 mg/m2/min by vein for the first 5 patients during pancreatic surgery. Next 15 subsequent patients receive 750 mg/m2 by vein at a fixed dose rate of 10 mg/m2/min.
16129488|NCT01938690|Device|Transcranial magnetic stimulation (TMS)|8 sessions of TMS followed by task specific training
16129489|NCT01938677|Radiation|Initial Gamma knife radiosurgery|
16129490|NCT01938664|Drug|Candesartan with CBT|8 mg, po (by mouth)
16129491|NCT01938664|Other|Placebo with CBT|
16129492|NCT01938651|Procedure|high field strength magnetic resonance imaging|Undergo 7T MRI
16129493|NCT01938651|Procedure|magnetic resonance spectroscopic imaging|Undergo 31P MRS
16129494|NCT01938651|Procedure|chemical exchange saturation transfer magnetic resonance imaging|Undergo CEST-MRI
16129495|NCT01938651|Procedure|diffusion-weighted magnetic resonance imaging|Undergo DW-MRI
16129496|NCT01938651|Procedure|dynamic contrast-enhanced magnetic resonance imaging|Undergo DCE-MRI
16129497|NCT01938638|Drug|BAY1143572|
16129498|NCT01938625|Drug|Simeprevir|Participants will receive 150 milligram capsule of simeprevir orally (by mouth) once daily with food for 24 weeks. In Part 1, if simeprevir pre-dose plasma concentration is greater than 7,300 nanogram per milliliter (ng/mL), participants will receive simeprevir 150 milligram capsule orally every other day to complete 24 weeks of treatment.
16129499|NCT01938625|Drug|Daclatasvir|Participants will receive 60 milligram tablet of daclatasvir orally once daily for 24 weeks.
16129500|NCT01938625|Drug|Ribavirin|Participants will receive 5 or 6 tablets of 200 milligram of ribavirin orally twice a day with food for 24 weeks.
16129547|NCT01938261|Drug|paracetamol|
16129548|NCT01938261|Drug|0.45 % saline solution|Placebo
16129598|NCT01937832|Drug|Faropenem|dosage form: Injection dosage:1200 mg frequency: Three times a day
16129501|NCT01938625|Drug|Cyclosporine|Participants will receive cyclosporine as one of the stable immunosuppressant therapy (no change in dose in the last month) for more than 3 months prior to the screening visit. Cyclosporine will be administered as per the manufacturer's prescribing information for 24 weeks.
16129502|NCT01938625|Drug|Tacrolimus|Participants will receive tacrolimus as one of the stable immunosuppressant therapy (no change in dose in the last month) for more than 3 months prior to the screening visit. Tacrolimus will be administered as per the manufacturer's prescribing information for 24 weeks.
16129503|NCT01938612|Drug|MEDI4736|MEDI4736 will be administered by IV infusion every 14, 21 or 28 days.
16129504|NCT01938612|Drug|tremelimumab|tremelimumab is administered by IV infusion every 4 weeks
16129505|NCT01938599|Drug|AM001 Cream, 7.5%|Cream, 2x daily for 12 weeks
16129506|NCT01938599|Drug|Placebo of AM001 Cream|Cream, 2x daily for 12 weeks
16129507|NCT01938586|Other|Steri-Strip|
16129508|NCT01938586|Other|Superficial sutures|
16129509|NCT01938573|Drug|Cisplatin|Given IV
16129510|NCT01938573|Drug|Gemcitabine Hydrochloride|Given IV
16129511|NCT01938573|Drug|Sirolimus|Given PO
16129512|NCT01938573|Procedure|Cystectomy|Undergo cystectomy when appropriate
16129513|NCT01938560|Other|Survey Responses|Subject understanding of the risk of urinary retention and the symptoms of acute urinary retention associated with retigabine will be assessed using the survey instrument.
16129514|NCT01938547|Drug|clevidipine|
16129515|NCT01938534|Drug|Helicobacter pylori eradication|
16129516|NCT01938521|Dietary Supplement|Red Grape Cells (RGC)|Red Grape Cells (RGC) 1000 mg powder once daily by mouth for three month
16129517|NCT01938521|Dietary Supplement|Placebo (for Red Grape Cells (RGC))|Placebo (for Red Grape Cells (RGC)) powder manufactured to mimic Red Grape Cells (RGC) 1000 mg powder
16129518|NCT01938508|Drug|Minocycline|minocycline hydrochloride capsules in microgranules equivalent to 100 mg of minocycline
16129519|NCT01938495|Device|NeuRx® Diaphragm Pacing System™ (DPS)|The NeuRx® Diaphragm Pacing System™ (DPS) is a four channel, implanted percutaneous diaphragm muscle stimulation system. Pictures of the device are provided in the Clinician's Manual for the NeuRx® DPS procedure and technique guide from the manufacture Synapse Biomedical, Inc. Under general anesthesia, the intramuscular electrodes are laparoscopically implanted in the diaphragm. The ends of the implanted electrodes are tunneled subcutaneously to an exit site on the chest or abdominal wall and connected to an external stimulator.
16129520|NCT01938482|Drug|0.3% GSK1940029 gel|Will be supplied as gel for topical application
16129521|NCT01938482|Drug|1% GSK1940029 gel|Will be supplied as gel for topical application
16129522|NCT01938482|Drug|0.3%/1% vehicle gel only|Will be supplied as gel for topical application
16129523|NCT01938469|Other|Liquid Meal|
16129524|NCT01938469|Other|Solid Meal|
16129525|NCT01938456|Drug|Trametinib|Biconvex film coated oral tablets for once daily use with unit dosage strength of 0.5mg and 2.0 mg for dose level of 2.0mg, 1.5mg, 1.0mg, and 0.5mg
16129526|NCT01938456|Drug|Docetaxel|Yellow or brownish yellow solution for injections with unit dosage strength of 20mg and 80 mg for intravenous infusion once every 3 weeks over at least one-hour infusion
16129527|NCT01938456|Drug|Filgrastim|Clear and colorless solution for once daily sub-cutaneous injection with unit dosage strength of 75 micrograms (mcg) for dose level of 50 mcg/meter^2 or 75 mcg/body
16129528|NCT01938443|Drug|GSK2256098|GSK2256098 250 mg will be supplied as white to off-white, round, biconvex tablets with no markings. GSK2256098 will be administered 30 minutes after a light meal with approximately 240 milliliter of water.
16129529|NCT01938443|Drug|Trametinib|Trametinib 0.5 mg will be supplied as capsules with no identifying markings. Trametinib will be administered orally under fasting conditions two hours after a meal.
16129530|NCT01938430|Drug|LDV/SOF|LDV/SOF FDC tablet administered orally once daily
16129531|NCT01938430|Drug|RBV|RBV tablets administered orally in a divided daily dose
16129532|NCT01938417|Drug|tobramycin|
16129533|NCT01938404|Biological|Octaplas|Octoplas infusion solution for IV administration
16129534|NCT01938404|Drug|Standard Plasma|Plasma given as replacement fluid
16129535|NCT01938391|Device|Stealth 360°® OAS|Cardiovascular Systems, Inc. Orbital Atherectomy System (OAS) is used prior to adjunctive balloon angioplasty (BA)
16129536|NCT01938378|Biological|Octaplas™|octaplas™ infusion solution for IV administration, ABO compatibile. Recommended dose for a plasma exchange is 40 to 60 ml/kg.
16129537|NCT01938352|Biological|CR8020|CR8020 15 mg/kg, administered by intravenous infusion
16129538|NCT01938352|Biological|Placebo|Placebo (hydrous dextrose in water for injection), administered by intravenous infusion
16129539|NCT01938339|Device|PET/MR|Multi-radiotracer PET/MR will be performed in patients with primary and recurrent prostate cancer
16129540|NCT01938326|Procedure|Approach Method|SIDG : 1 incision (umbilicus 2.5cm) TLDG : 5 incisions (12mm ports X 3, 5mm ports X 2, umbilicus extension up to 3cm for specimen delivery)
16129541|NCT01938313|Procedure|ERAS perioperative cares|"Patient's preoperative counseling & education before surgery
~No Bowel preparation
~Oral Carbohydrate Solution (OCS) loading until 2hours before surgery
~Fluid restriction & Management by pulse contour analysis or transesophageal doppler
~Early mobilization
~Early oral feeding (postoperative 1 day - sips of water, 2 days - semifluid diet (SFD), 3 days - soft blended diet (SBD))
~Epidural patient controlled analgesics (no opioids analgesics)
~Postoperative Nausea Active Control
~Thromboembolism prophylaxis by low molecular weighted heparin (LMWH)
~Perioperative High content Oxygen therapy
~No drain insertion
~No Levin tube
~Patients will be discharged at POD#4 if there's no problem."
16129542|NCT01938313|Procedure|Conventional perioperative cares|"No Patient's preoperative counseling & education before surgery
~Bowel preparation
~No Oral Carbohydrate Solution (OCS) loading until 2hours before surgery
~Conventional Fluid Management by clinical signs (Urine output, heart rate etc.)
~Conventional Mobilization
~Conventional oral feeding (POD#2 SOW, #3 SFD, #4 SBD)
~IV PCA
~Postoperative Nausea Control if needed
~No Thromboembolism prophylaxis
~No or Low Content Oxygen therapy
~Routine drain insertion
~Levin tube insertion if needed"
16129543|NCT01938300|Drug|Magnesium Sulfate|
16129544|NCT01938300|Drug|Normal saline|
16129545|NCT01938287|Device|SENSIMED Triggerfish|
16129546|NCT01938274|Other|Educational intervention|A 30-minute discussion and slide presentation with a trained member of the research team.
16129549|NCT01938248|Drug|Apixaban|apixaban at a dose of 5 mg twice daily (2.5 mg twice daily if 2 or more of: age > 80, weight ≤ 60 kg or serum creatinine ≥ 133 mmol/L)
16129550|NCT01938248|Drug|aspirin|aspirin 81 mg once daily
16129551|NCT01938235|Drug|Exenatide|Intravenous bolus and 24-hour infusion of exenatide
16129552|NCT01938235|Drug|Placebo|Intravenous bolus and 24-hour infusion of placebo
16129553|NCT01938222|Procedure|Short Stitch|MonoMax® suture material USP (United States Pharmacopeia) 2/0, 150 cm, HR (half-round) 26 mm needle, will be applied in the short stitch technique (6:1) for abdominal wall closure.
16129554|NCT01938209|Other|seated thoracic manipulation|seated general thoracic spine manipulation
16129555|NCT01938209|Other|supine specific thoracic spine manipulation|supine specific thoracic spine manipulation
16129556|NCT01938196|Drug|KWA-0711|
16129557|NCT01938196|Drug|Placebo|
16129558|NCT01938183|Procedure|Full-mouth periodontal debridement|full-mouth periodontal debridement using an ultrasonic device in a single session for approximately 1 hour
16129559|NCT01938183|Drug|Metronidazole tablet|750 mg metronidazole tablets
16129560|NCT01938183|Drug|placebo gel|semi-solid suspension containing carbopol
16129561|NCT01938183|Drug|Metronidazole benzoate gel|15% Mtz benzoate in semi-solid suspension containing carbopol (gel)
16129562|NCT01938170|Biological|FluMist|Subjects receiving Flumist vaccine
16129563|NCT01938157|Procedure|Diffusion-weighted MR imaging|An addition 90 seconds of DWI will be added to a clinical breast MRI for all patients agreeing to participate in the study.
16129564|NCT01938144|Drug|Advil Congestion Relief|Orally adminstered, 200 mg Ibuprofen/10 mg Phenylephrine tablet, 4x/day, up to 8 doses.
16129565|NCT01938144|Drug|Advil Allergy and Congestion Relief|Orally adminstered, 200 mg Ibuprofen/10 mg Phenylephrine/4 mg Chlorpheniramine tablet, 4x/day, up to 8 doses.
16129566|NCT01938144|Drug|Paracetamol|Acetaminophen 500 mg, 4x/day, up to 8 doses.
16129567|NCT01938131|Device|repeated Muscle Vibration (rMV) (Cro ® System)|The patients will be subjected to 3 daily applications of rMV of 10 minutes each, for 3 consecutive days. Between two successive applications will be observed a break of at least 15 seconds. The probe of the specific instrument (Cro ® System) will be placed near the supero-medial margin of the patella, on both quadriceps
16129568|NCT01938118|Behavioral|Obesity Prevention Group|
16129569|NCT01938118|Behavioral|Injury Prevention Group|
16129570|NCT01938105|Other|Nimotuzumab+chemoradiotherapy|"Nimotuzumab 200mg per week will be administered concurrent with platinum-based chemotherapy and intensity-modulated radiation therapy. After the preoperative treatment, patients will be assessed for tumor response and operability. For those who are considered to be candidates for operation, radical surgery will be performed.
~--------------------------------------------------------------------------------"
16129571|NCT01938092|Drug|Diazepam|
16129572|NCT01938092|Drug|Placebo|
16129573|NCT01938079|Drug|Ketamine|Ketamine will be initiated as a one-time 40 mg bolus of ketamine followed by a continuous intravenous infusion of 5 micrograms/kg/min at the start of ECMO.
16129574|NCT01938079|Other|Sedative drug regimen|(Standard of Care) Fentanyl or hydromorphone and midazolam infusions will be administered to all patients and titrated at the discretion of the attending physician to maintain the desired level of sedation.
16129575|NCT01938066|Device|Procellera|bioelectric wound dressing
16129576|NCT01938066|Device|negative pressure therapy|
16129577|NCT01938053|Other|Call when test results are ready|Patients are called when the test results are ready
16129578|NCT01938053|Other|Text message when test results are ready|Patients receive a text message when results are ready
16129579|NCT01938053|Other|Call and text message when test results are ready|Patients receive both a call and a text message when test results are resay
16129580|NCT01938040|Drug|ibuprofen|single preoperative dose prior to surgery
16129581|NCT01938040|Other|sugar water/placebo|single preoperative dose prior to surgery
16129582|NCT01938027|Procedure|Transanal total mesorectal excision|Laparoscopy-assisted transanal total mesorectal excision
16129583|NCT01938001|Drug|Rituximab|Rituximab 375mg/m^2 IV every week in Cycle 1 (Days 1, 8, 15 and 22) on Day 1 of every 28 day cycle from Cycles 2 to 5
16129584|NCT01938001|Drug|Lenalidomide|Lenalidomide 20mg by mouth (PO) daily on Days 1 to 21 every 28 days up to 12 cycles
16129585|NCT01938001|Drug|Placebo|Placebo (identical matched capsule) PO daily on Days 1 to 21 every 28 days
16129586|NCT01937988|Other|Doula Arm|
16129587|NCT01937975|Drug|Grazoprevir|100 mg oral tablet administered once a day for 10 days
16129588|NCT01937975|Drug|Elbasvir|50 mg oral tablet administered once a day for 10 days
16129589|NCT01937949|Device|Custom-made Zenith® Fenestrated AAA Endovascular Graft:|The graft will be inserted through arteries in the groin (called endovascular repair). Endovascular repair is a procedure that uses catheters that go inside your blood vessel to place a stent graft above and below the aneurysm. This procedure lines the aneurysm with a new lining (stent) so blood does not fill the artery any more.
16129590|NCT01937936|Behavioral|Cognitive Behavioral Therapy (CBT)|Family caregivers in the CBT group will receive 8 1-hour weekly Cognitive Behavioral Therapy (CBT) sessions, which will take place in their home.
16129591|NCT01937936|Behavioral|Health Education|Family caregivers in the Education group will receive 8 1-hour weekly sessions of general health education on selected topics, which will take place in their home.
16129592|NCT01937910|Behavioral|TRAIT Task|Increased paretic arm will be manipulated through the performance of a semi-immersive virtual reality-based intercept and release task called TRAIT (TRack And Intercept Task), which is performed in an interactive environment. TRAIT employs an open source Kinect sensor, which tracks 3-D joint movement. Participants are asked to control an on-screen icon using movements of their paretic arm to intercept a moving object as it emerges from the side of a computer screen. Once intercepted, they must accurately throw the object to hit a target. Participants move up through 10 levels of the game as their skill improves. Participants will complete 10 TRAIT training sessions in 4 weeks for a total of 10,000 experimental movements.
16129593|NCT01937897|Other|Bi-lateral massage|Unilateral massage on the left side of the body.
16129594|NCT01937884|Drug|Parenteral Nutrition|
16129595|NCT01937871|Drug|5 mg Tadalafil|Administered orally
16129596|NCT01937871|Drug|Placebo|Administered orally
16129597|NCT01937871|Drug|0.2 mg Tamsulosin|Administered orally
16129599|NCT01937832|Drug|Ertapenem|dosage form: Injection dosage:1000 mg frequency: once a day
16129600|NCT01937819|Device|SMART arm|The SMARTPHONE application for self judging bowel preparation by taking the picture of stool form.
16129601|NCT01937806|Drug|besifovir 150mg|Besifovir 150 mg q.d. + Placebo of Tenofovir Disoproxil Fumarate 300 mg q.d. + L-carnitine (L-Carn Tab. 330 mg) 660 mg q.d.
16129602|NCT01937806|Drug|tenofovir 300mg|Placebo of Besifovir 150 mg q.d. + Tenofovir Disoproxil Fumarate 300 mg q.d. + Placebo of L-carnitine (L-Carn Tab. 330 mg) 660 mg q.d.
16129603|NCT01937793|Other|effortful swallowing exercise|voluntarily increases the posterior tongue base pushing effort while swallowing
16129604|NCT01937793|Other|Mendelsohn swallowing exercise|voluntarily increase the extent and duration of laryngeal elevation while swallowing
16129605|NCT01937767|Drug|Remimazolam|
16129606|NCT01937767|Drug|Propofol|
16129607|NCT01937767|Drug|Sevoflurane|
16129608|NCT01937767|Drug|Remifentanil|
16129609|NCT01937767|Drug|Fentanyl|
16129610|NCT01937767|Drug|Rocuronium|
16129611|NCT01937754|Dietary Supplement|Nitric Oxide supplement|Lozenge consisting of beetroot and 75 mg caffeine
16129612|NCT01937754|Dietary Supplement|Placebo|Same form factor and flavor as test lozenge but contains no active ingredients
16129613|NCT01937728|Drug|A: Peg-interferon alpha-2a & Ribavirin|Arm A: Patients who have low viral loads (LVL, defined as baseline HCV RNA < 400,000 IU/mL) and RVR will be treated with PEGASYS 180ug/week and Ribavirin 1000-1200 mg/day for 24 weeks with a follow-up period of 24 weeks.
16129614|NCT01937728|Drug|B: Peg-interferon alpha-2a & Ribavirin|"Patients who have HVL and an RVR will be randomized into arm B or arm C with a ratio of 1:1.
~Arm B: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 36 weeks with a follow-up period of 24 weeks."
16129615|NCT01937728|Drug|C: Peg-interferon alpha-2a & Ribavirin|"Patients who have HVL and an RVR will be randomized into arm B or arm C with a ratio of 1:1.
~Arm C: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks."
16129616|NCT01937728|Drug|D: Peg-interferon alpha-2a & Ribavirin|Arm D: Patients who do not achieve a RVR but have HCV RNA PCR-seronegative at week 12 of treatment will be treated with PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks.
16129617|NCT01937728|Drug|E: Peg-interferon alpha-2a & Ribavirin|"Patients who do not achieve a RVR and remain HCV RNA PCR-seropositive at week 12 of treatment will be randomized into arm E or arm F with a ratio of 1:1.
~Arm E: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 48 weeks with a follow-up period of 24 weeks."
16129618|NCT01937728|Drug|F: Peg-interferon alpha-2a & Ribavirin|"Patients who do not achieve a RVR and remain HCV RNA PCR-seropositive at week 12 of treatment will be randomized into arm E or arm F with a ratio of 1:1.
~Arm F: PEGASYS® 180 ug/week and Ribavirin 1000-1200 mg/day for 72 weeks with a follow-up period of 24 weeks."
16129619|NCT01937715|Drug|PF-05212384|PF-05212384 at the Recommended phase 2 dose (RP2D/MTD) weekly
16129620|NCT01937715|Drug|FOLFIRI regimen|The RP2D/MTD dose of FOLFIRI regimen every 2 weeks
16129621|NCT01937715|Biological|Bevacizumab|5 mg/m^2 every 2 weeks or 7.5 mg/m^2 every 3 weeks
16129622|NCT01937715|Drug|FOLFIRI|Full dose FOLFIRI regimen every 2 weeks
16129623|NCT01937702|Other|0.9% NaCl (sodium chloride)|
16129624|NCT01937689|Drug|Pyrotinib|Pyrotinib either at 80, 160, 240, 320, 400, 480 mg ....., p.o. once daily.
16129625|NCT01937663|Drug|KWA-0711|
16129626|NCT01937650|Drug|Radiotherapy plus metronidazole|Metronidazole was added to the standard radiotherapy that is routinely used.
16129627|NCT01937637|Behavioral|Cognitive Behavioral Intervention for Breathlessness|Cognitive behavioral intervention for breathlessness, delivered by nurse practitioners during outpatient oncology appointments, in up to 8 patients with advanced lung cancer.
16129628|NCT01937624|Device|Diagnostic Ultrasound|
16129629|NCT01937624|Radiation|X-ray imaging|
16129630|NCT01937611|Drug|Dexmedetomidine|Dexmedetomidine
16129631|NCT01937611|Drug|Midazolam|Midazolam
16129632|NCT01937598|Drug|Placebo|Patients administered a single dose of placebo during a mixed meal challenge.
16129633|NCT01937598|Other|Mixed meal test|Subjects will be instructed to consume the mixed meal test within 20 minutes. The exact start and stop time of the mixed meal test consumption will be recorded in the CRF. The mixed meal test procedures will be identical for all subjects randomised in the study. To detect the plasma glucose excursion after mixed meal test, plasma glucose will be closely monitored
16129634|NCT01937598|Drug|Liraglutide|Patients on metformin monotherapy will, after screening and randomization, enter a run-in period of 2 weeks with the additional treatment of liraglutide (0.6 mg/d for 1 week followed by 1.2 mg/d for another week) that will be continued for the entire duration of the study.
16129635|NCT01937598|Drug|Sitagliptin|Patients administered a single dose of Sitagliptin during a mixed meal challenge.
16129636|NCT01937585|Behavioral|Partner and CDC brochure condition|Receipt of a brochure designed for female partners of African American men designed to provide information about prostate cancer screening and strategies for influencing her mate to schedule a discussion with a health care provider about whether to undergo prostate cancer screening, in combination with receipt of the comparator brochure (CDC brochure for African American about prostate cancer screening).
16129637|NCT01937585|Behavioral|CDC brochure only condition|Receipt of CDC brochure by female partners of African American men designed to provide African American men information and guidance concerning whether to undergo PSA and/or DRE screening for prostate cancer
16129638|NCT01937572|Other|Visionaire system (Knee MRI)|
16129639|NCT01937572|Other|No Knee MRI|
16129640|NCT01937559|Biological|Tranexamic acid (TXA)|1.5g of TXA in 100ml normal saline solution
16129641|NCT01937559|Drug|Normal saline|
16129642|NCT01937546|Procedure|Primary delivery of anterior shoulder|
16129643|NCT01937546|Procedure|Primary delivery posterior shoulder|
16129644|NCT01937533|Procedure|Magnetic Resonance Imaging using an endovaginal receiver coil|
16129645|NCT01937520|Device|acupuncture|One half of subjects will receive a standardized acupuncture regiment
16129646|NCT01937520|Device|no acupuncture|placebo
16129647|NCT01937507|Drug|HAI with FOLFOX|HAI with FOLFOX q 3 weeks
16129783|NCT01936506|Behavioral|Cognitive Training B|
16129648|NCT01937494|Drug|histamine-benzylic alcohol (magistral preparation)|passive exposure to histamine during a bronchial hyperresponsiveness challenge
16129649|NCT01937481|Behavioral|The Food Friends|The Food Friends is a research-based preschool program designed to address childhood obesity by establishing healthful eating and physical activity behaviors in preschool-aged children. The Food Friends: Fun With New Foods (12 weeks) focuses on helping children increasing children's willingness to try new foods and The Food Friends: Get Movin' With Mighty Moves (18 weeks) aims to enhance preschoolers' gross motor skill development. In effort to sustain the preschool behavior changes, the messages from The Food Friends® (Super Taster and Mighty Mover) will be extended into early elementary school through a 'booster' program. The booster program will consist of a kindergarten and 1st grade curriculum with 5 monthly units.
16129650|NCT01937468|Other|Treg-enriched infusion|Treg-enriched Cell Dose: Participants will be targeted to a defined dose of donor Treg-enriched total nucleated cells. Initial enrollment will be at target dose-level A. Subsequent cohorts will be dose escalated/de-escalated per the schema
16129651|NCT01937468|Drug|Interleukin-2|Interleukin-2: Starting the day of Treg-enriched cell infusion, each participant will receive daily subcutaneous IL-2 for self-administration for 8 weeks, followed by a 4-week hiatus. IL-2 will be administered on an outpatient basis. Expected toxicities and potential risks as well as dose modifications are described in Section 6 (Expected Toxicities and Dosing Delays/Dose Modification).
16129652|NCT01937455|Biological|rAAV1-PG9DP|4x10^12 vg administered intramuscularly
16129653|NCT01937455|Biological|rAAV1-PG9DP|4x10^13 vg administered intramuscularly
16129654|NCT01937455|Biological|rAAV1-PG9DP|8x10^13 vg administered intramuscularly
16129655|NCT01937455|Biological|rAAV1-PG9DP|1.2x10^14 vg administered intramuscularly
16129656|NCT01937442|Drug|Thalidomide Celgene™|200mg once daily and by mouth
16129657|NCT01937429|Device|Colonoscopy with blue Indigo Carmin®|
16129658|NCT01937429|Device|Standard colonoscopy with insufflation of air|
16129659|NCT01937416|Biological|autologous bone marrow mononuclear cells|Bone marrow was taken from patient oneself and mononuclear cells were isolated with deleting erythrocyte by density gradient centrifugation. Bone marrow mononuclear cells were transplanted into ischemia regions of lower limb through intramuscular injection.
16129660|NCT01937390|Drug|Tiotropium 2x2.5µg tiotropium (equivalent to 2x3.154µg tiotropium bromide monohydrate) Respimat® inhaler and cartridge Solution for inhalation|Respimat® inhaler and cartridge Solution for inhalation
16129661|NCT01937390|Drug|Indacterol 300 µg|inhalation powder
16129662|NCT01937390|Drug|Tiotropium 18µg (equivalent to 22.5µg tiotropium bromide monohydrate) HandiHaler® device Inhalation powder, hard capsule|HandiHaler® device Inhalation powder, hard capsule
16129663|NCT01937390|Drug|Indacterol 150 µg|inhalation powder
16129664|NCT01937364|Drug|Baclofen|Baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
16129665|NCT01937364|Drug|Placebo|Identical appearing placebo every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
16129666|NCT01937351|Device|Pantheris System|Atherectomy using directional visualization and imaging as an adjunct to fluoroscopy to aid removal of plaque from diseased lower extremity arteries.
16129667|NCT01937338|Drug|AZD7624|nebuliser solution; 20 mg/mL for inhalation
16129668|NCT01937338|Drug|Placebo|nebuliser solution for inhalation
16129669|NCT01937325|Drug|ivacaftor|active arm
16129670|NCT01937325|Drug|placebo|active arm
16129671|NCT01937312|Drug|Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension|
16129672|NCT01937312|Drug|Vehicle|Inactive ingredients used as a placebo comparator
16129673|NCT01937312|Drug|Prostaglandin analogue|
16129674|NCT01937299|Drug|Brinzolamide 1%/brimonidine 0.2% ophthalmic suspension|
16129675|NCT01937299|Drug|Vehicle|Inactive ingredients used as a placebo comparator
16129676|NCT01937299|Drug|Travoprost 0.004% ophthalmic solution|
16129677|NCT01937260|Drug|Brodalumab|Group 1 consists of 20 subjects and will receive 2 oral doses of midazolam and a single SC dose of brodalumab. Group 2 consists of 10 subjects and will receive a single SC dose of brodalumab.
16129678|NCT01937247|Procedure|Patients will be inducted in the induction room|The patients will be inducted in the induction room
16129679|NCT01937247|Procedure|Redesigned process|The registered nurse will call in the house keeper to start cleaning of the OR (parallel processing) before the patient exits the room
16129680|NCT01937247|Drug|patient will be reversed with sugammadex 4mg/kg IV|The patient will be reversed with sugammadex 4mg/kg IV, and then extubated before being moved out of the OR
16129681|NCT01937247|Procedure|STANDARD PROCESS|standard process
16129682|NCT01937234|Drug|Metoclopramide|"Intravenous injection of 10mg metoclopramide, at enrollment, then every 2 hours.
~Maximum of 3 doses."
16129683|NCT01937234|Drug|Placebo|"Intravenous injection of 0.9% sodium chloride, at enrollment, then every 2 hours.
~Maximum of 3 doses."
16129684|NCT01937221|Other|spectral-domain optical coherence tomography (SD-OCT)|Intervention same to all groups.
16129685|NCT01937208|Radiation|intensity modulated radiation therapy in both arms|
16129686|NCT01937208|Drug|concurrent chemotherapy with radiation|docetaxel plus cisplatin were used weekly in both arms
16129687|NCT01937195|Device|AccuCath Intravenous Catheter System|AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
16129688|NCT01937182|Drug|Citalopram|Citalopram 10-40 mg per day administered orally
16129689|NCT01937182|Drug|Placebo|1/2-2 tablets per day with no intrinsic drug activity
16129690|NCT01937169|Behavioral|Motor Task|A motor task executed for 30 minutes after drug adminidtration
16129691|NCT01937169|Drug|Levodopa tablet|
16129692|NCT01937169|Behavioral|Sham non-motor task|A non-motor task )sham condition) will be executed for 30 minutes after drug adminidtration
16129693|NCT01937169|Drug|Placebo pill|
16129694|NCT01937156|Drug|SP-01 (Granisetron Transdermal Delivery System)|SP-01 will be applied to the upper arm 24-48 hours before the start of chemotherapy, and left in place for 7 days.
16129784|NCT01936493|Genetic|DNA analysis|At a future time DNA analysis will be performed
16129695|NCT01937156|Drug|Granisetron Hydrochloride Tablet|Granisetron hydrochloride 1 mg tablets will be administered 1 hour before administration of chemotherapy at the first time, then taken 12 hours after the first dose later; 2 mg/day bid, for ≥ 2 days.
16129696|NCT01937143|Behavioral|Low intensity intervention|Pamphlet with information about pain management during infant immunizations at birth of a newborn infant
16129697|NCT01937143|Behavioral|High intensity intervention|Pamphlet and video with information about pain management during immunizations at birth of a newborn infant
16129698|NCT01937143|Behavioral|Control|General information about infant immunizations at birth of a newborn infant
16129699|NCT01937130|Drug|IDN-6556|
16129700|NCT01937130|Other|Placebo|
16129701|NCT01937117|Procedure|Positron emission tomography (PET)|PET will be performed at baseline and on day 15
16129702|NCT01937117|Drug|Trastuzumab|8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV
16129703|NCT01937117|Drug|Pertuzumab|840 mg as a loading dose, then 420 mg every 3 weeks, IV
16129704|NCT01937104|Drug|Desflurane|"Anesthesia with desflurane in both Group 1 and Group 2
~- adjust MAC to maintain BIS between 40-60"
16129705|NCT01937104|Drug|Remifentanil|"Adjuvant continuous administration
~- adjust effect site concentration to maintain changes of vital sign below 20%"
16129706|NCT01937104|Device|Ultrasonographic measurement of ONSD|Patients were placed in the supine position with their eyes closed, and a thick gel layer was applied to the closed upper eyelid. The 7.5-MHz linear probe was placed on the gel without excessive pressure and adjusted to the proper angle for displaying the entry of the optic nerve into the globe. The intensity of the ultrasound was adjusted to display optimal contrast between the retrobulbar echogenic fat tissue and the vertical hypoechoic band. An ultrasound beam was focused on the retrobulbar area (4 cm deep) using the lowest possible acoustic power that could measure ONSD. The ONSD was measured 3 mm behind the optic disc. Measurements were performed in the transverse and sagittal planes of both eyes, and the final ONSD value was calculated by averaging 4 measured values.
16129707|NCT01937104|Procedure|Mechanical ventilation|After tracheal intubation, the lungs of the patients were then ventilated with oxygen in air (1:2) using a tidal volume of 8-10 mL/kg and a respiratory rate of 10-12/min, and the ventilation rate was adjusted to maintain the end-tidal carbon dioxide partial pressure between 35 and 40 mmHg and peak inspiratory pressure below 30 cmH2O.
16129708|NCT01937104|Procedure|Trendelenburg position - 30 degree|Trendelenburg position - 30 degree
16129709|NCT01937104|Procedure|Reverse Trendelenburg position - 30 degree|Reverse Trendelenburg position - 30 degree
16129710|NCT01937078|Drug|Famotidine|Each patient will receive 4 randomized treatment phases - three famotidine (one at each of the dose levels) and one placebo. Each treatment phase will last for 14 days. Doses of drug will be titrated upwards, starting at 40mg once daily on day one, 40mg twice daily on day two, and 80mg twice daily (or placebo + drug equivalent) from day three and then continue on this dose for the next 12 days. Regardless of treatment phase, subjects will take 2 tablets twice daily, with varying ratios of active famotidine to placebo. Thus famotidine 80mg/d will consist of 1 tablet of 40 mg famotidine plus 1 tablet of placebo twice a day; 120 mg /d famotidine will be 2 tablets at 40 mg morning and 1 tablet famotidine 40 mg plus 1 tablet placebo evening; famotidine 160 mg/d will be famotidine 40 mg tablets, 2 tablets twice a day. The placebo phase will consist of 2 placebo tablets twice a day.
16129711|NCT01937065|Other|No treatment|
16129712|NCT01937052|Other|Sample collection|Participants will be offered the option to consent for blood (preferred) or saliva for DNA pharmacogenetic testing, and for additional samples for banking for future studies.
16129713|NCT01937052|Behavioral|Patient-reported outcomes|Patient reported outcomes (PROs) will be collected via electronic questionnaires that will be administered to patients at regular intervals per the study calendar; in most cases, this should coincide with medical oncology follow-up.
16129714|NCT01937039|Procedure|Sample collection|Blood, tissue, urine, and other samples may be collected
16129715|NCT01937026|Drug|Baricitinib|Administered orally
16129716|NCT01937026|Drug|Probenecid|Administered orally
16129717|NCT01937013|Drug|Intranasal oxytocin|Oxytocin can be given intravenously (with a needle) or intranasally (a spray into the nose). The intravenous form of drug is approved by Health Canada for use in pregnancy. The intranasal formulation is not currently approved for use by Health Canada, but is used in Europe to induce labour in pregnant women or aid lactation (breastfeeding). Participants will be randomized to receive 72 IU intranasal oxytocin on either study visit 2 or 3.
16129718|NCT01937013|Drug|Saline Nasal Mist|Participants will be randomized to receive placebo on either study visit 2 or 3.
16129719|NCT01936974|Drug|Gemcitabine|Patient to receive gemzar
16129720|NCT01936974|Drug|Bevacizumab|Patient to receive avastin
16129721|NCT01936974|Drug|Carboplatin|Patient to receive carboplatin
16129722|NCT01936974|Drug|Cisplatin|Patient to receive cisplatin
16129723|NCT01936974|Drug|Oxaliplatin|Patient to receive Oxaliplatin
16129724|NCT01936961|Drug|CTLA-4 Antibody|administered intravenously over 90 minutes every 3 weeks for a total of four doses
16129725|NCT01936961|Radiation|Hypofractionated Radiotherapy|
16129726|NCT01936948|Procedure|Clip closure|Patients will be randomized to either closing the mucosal defect after polyp removal or not closing the mucosal defect using clips (main intervention and comparison). The resection margins will be approximated using clips. Complete closure is defined as approximated margins with less than 1cm gap between clips. All patients will further be randomized to two different settings of electrocautery (EndoCut or Coagulation) to standardize otherwise variable electrocautery practice, and for explorative analysis.
16129727|NCT01936935|Other|Low-fat dairy|2 servings/d of 2% non-flavored, unsweetened milk + 1 serving/d sweetened low-fat yogurt
16129728|NCT01936935|Other|Sugar-sweetened beverages|2 servings/d of non-diet soda + 1 serving/d of non-dairy pudding
16129729|NCT01936922|Device|GaitAid®|Provides visual and auditory cues for walking.
16129730|NCT01936909|Drug|Anakinra (weeks 1-2)|Anakinra 100 mg daily for weeks 1 and 2
16129731|NCT01936909|Drug|Anakinra (weeks 3-12)|
16129732|NCT01936909|Drug|Placebo|
16129733|NCT01936896|Drug|Alpha 1-Antitrypsin|
16129734|NCT01936883|Radiation|HDR|High dose rate brachytherapy
16129735|NCT01936883|Radiation|LDR|Low dose rate brachytherapy boost
16129884|NCT01935882|Drug|Artemether-Lumefantrine with a single dose of 0.4mg/kg primaquine|
16129885|NCT01935869|Drug|LEO 90100|
16129736|NCT01936870|Drug|Fesoterodine (Toviaz)|Fesoterodine 4 mg or 8 mg orally. Toviaz will be dosed according to labeling. The administration and duration of therapy will be determined by the treating physician to meet the patient's needs for treatment.
16129737|NCT01936857|Drug|Buprenorphine/naloxone|Buprenorphine/naloxone induction begins with a 2-4mg test dose followed by additional doses on the day of induction to relieve withdrawal symptoms, and then titrated to a maintenance dose between 8-24 mg/day over 1 to 3 days. Doses will be directly observed and occur daily. After a minimum of 2 weeks, dosing may be changed to 3 or 4 times per week, as determined clinically appropriate by the HIV clinic study physician. Dosing will remain flexible to a maximum dose of 24mg for daily dosing and 32mg for every other day dosing, as deemed clinically appropriate by the study physician.
16129738|NCT01936857|Drug|Methadone Maintenance Therapy|Subjects randomized to methadone maintenance therapy (MMT) referral will meet with an HIV clinic case manager who will facilitate referral to MMT. Methadone dosing will be managed by MMT staff, who dispense methadone according to Ministry of Health guidelines for MMT.
16129739|NCT01936844|Drug|Anakinra (high dose)|Anakinra 100 mg daily twice daily for days 1, 2, and 3
16129740|NCT01936844|Drug|Anakinra (standard dose)|Anakinra 100 mg daily for days 4-14
16129741|NCT01936844|Drug|Placebo|Placebo twice daily for days 1, 2, and 3
16129742|NCT01936844|Drug|Placebo|Placebo daily for days 4-14
16129745|NCT01936805|Drug|Rosuvastatin|A 40 mg loading dose of rosuvastatin was administrated 24 h before the PCI.
16129746|NCT01936779|Dietary Supplement|Dietary supplement: fatty acid|Consumption of n-3 fatty acids for 8 weeks
16129747|NCT01936779|Dietary Supplement|Dietary supplement: fatty acid|Consumption of olive oil for 8 weeks.
16129748|NCT01936753|Behavioral|Trained Mentor Mother and Supervisor|Trained, closely supervised Mentor Mothers guide and support the mother-infant pair to achieve timely and complete access to, and retention in PMTCT services along the entire cascade.
16129749|NCT01936740|Procedure|cataract surgery|
16129750|NCT01936727|Procedure|cataract surgery|
16129751|NCT01936714|Procedure|cataract surgery|
16129752|NCT01936701|Procedure|bilateral cataract surgery|same-day bilateral cataract surgery with implantation of intraocular lens
16129753|NCT01936688|Drug|MK-3222 200 mg|MK-3222 200 mg administered SC.
16129754|NCT01936688|Drug|MK-3222 100 mg|MK-3222 100 mg administered SC.
16129755|NCT01936688|Drug|Placebo to MK-3222|Matching placebo to MK-3222 administered SC.
16129756|NCT01936688|Drug|Placebo to Etanercept|Matching placebo to etanercept for subcutaneous injection.
16129757|NCT01936688|Drug|Etanercept 50 mg|Etanercept 50 mg for subcutaneous injection.
16129758|NCT01936675|Other|Genetic Risk Score|Patients in this arm will receive their genetic-informed risk for having a heart attack.
16129759|NCT01936662|Device|LMA|Patients randomized to the LMA group had their airways maintained with a LMA device
16129760|NCT01936662|Device|ETT|Patients assigned to this group had an ETT placed to maintain their airway, as is standard of care at this hospital
16129761|NCT01936649|Drug|AdreView (Iobenguane I 123 Injection)|AdreView 10 mCi as a single i.v administration
16129762|NCT01936636|Drug|Fentanyl|
16129763|NCT01936623|Behavioral|Computerized Brief Intervention|No additional information needed.
16129764|NCT01936610|Other|role play|In this method, researcher with two other co-researchers played 3 scenarios in 7 steps (for each scenario)including warm up, selecting participant, preparing the scene, preparing observers, play ,discussion and evaluation and generalization to education about advantages and disadvantages of normal delivery and cesarean section.
16129765|NCT01936610|Other|lecture|Describe advantages and disadvantages in one 90-min session
16129766|NCT01936597|Other|Therapeutic and preventive strategies|Single set (control Arm)
16129767|NCT01936597|Other|Therapeutic and preventive strategies|Controller
16129768|NCT01936597|Other|Therapeutic and preventive strategies|Audio
16129769|NCT01936584|Procedure|TAPP repair for inguinal hernias|
16129770|NCT01936584|Procedure|TEP repair for inguinal hernia|
16129771|NCT01936584|Other|EuraHS-QoL questionnaire|questionnaire administration
16129772|NCT01936584|Other|Carolina Comfort Scale|questionnaire administration
16129773|NCT01936571|Other|Blood samples|Blood samples, that were collected, processed and stored in the Maastro biobank in a standardized way, will be used to measure CRP, LDH, Osteopontin, CA-9 IL-6, IL-8, CEA, CYFRA 21-1, and α-2M. Clinical data will be retrieved from the electronic medical files.
16129774|NCT01936558|Other|Far infrared ray to the sole|exposure 40-minute far infrared ray to the sole for each person/amputee.
16129775|NCT01936545|Drug|propofol during liver transplantation.|The anesthesia was maintained with propofol during liver transplantation.
16129776|NCT01936545|Drug|Desflurane during liver transplantation.|The anesthesia was maintained with desflurane during liver transplantation.
16129777|NCT01936532|Drug|MLN9708|"Induction therapy Patients will receive 3 cycles of induction therapy with MLN9708 (4 mg) on Days 1, 8 and 15, plus Lenalidomide (25 mg) on Days 1 through 21 and Dexamethasone (40 mg) on Days 1, 8, 15 and 22 of a 28-day cycle.
~Consolidation therapy
~Early consolidation (consolidation part 1) will comprise 2 cycles of MRD identical to induction therapy.
~Late consolidation (consolidation part 2) will consist in 6 additional cycles of MLN9708 (4 mg on Days 1, 8 and 15) plus lenalidomide (25 mg on Days 1 through 21) of a 28-day cycle.
~Maintenance therapy MLN9708 monotherapy (4 mg/day), will be given on days 1, 8 and 15 of a 28 day cycle, during 12 months."
16129778|NCT01936532|Drug|Lenalidomide|
16129779|NCT01936532|Drug|Dexamethasone|
16129780|NCT01936519|Drug|Arm A: Everolimus|Conversion to Everolimus immunosuppression combined with mycophenolic acid (Myfortic: MPA), and complete discontinuation of Calcineurin inhibitor at 3 months post transplant.
16129781|NCT01936519|Drug|Calcineurin Inhibitor|Comparison Arm: Continuation with standard immunosuppressive therapy consisting of Calcineurin inhibitor associated with mycophenolic acid (Myfortic: MPA).
16129782|NCT01936506|Behavioral|Cognitive Training A|
16129785|NCT01936493|Other|Hormonal analysis|Participants will provide blood samples so that hormonal factors that influence outcomes of leiomyoma treatments can be assayed.
16129786|NCT01936480|Drug|Moxifloxacin 400mg once time|
16129787|NCT01936480|Drug|Placebo|
16129788|NCT01936467|Device|Standard technique EUS-FNA|Standard suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with use of 10cc suction syringe.
16129789|NCT01936467|Device|Capillary suction technique for EUS FNA|Capillary suction Endoscopic Ultrasound- Fine Needle Aspiration (EUS-FNA) technique using the 22-gauge (Expect needle; Boston Scientific) needle: 15 to-and-fro movements within the lesion will be performed with simultaneous minimal negative pressure provided by pulling the needle stylet slowly and continuously
16129790|NCT01936441|Behavioral|Cognitive Behavioral Therapy-Insomnia (CBT-I)|See Experimental Arm Description
16129791|NCT01936441|Behavioral|Menopause Education Control (MEC)|See Experimental Arm Description
16129792|NCT01936428|Other|interview|
16129793|NCT01936415|Device|Vanguard|A prospective randomized study where the patients are randomized to receive one of two prostheses (tibial components) with different coating: Vanguard pourous coating, Biomet and Regenerex® Primary Tibial Tray, Biomet. Both prostheses are available and approved by the FDA. The main difference between the implants is the coating of the tibial tray
16129794|NCT01936415|Device|Regenerex|
16129795|NCT01936402|Behavioral|Education of chest compression depth|An American Heart Association Basic Life Support faculty educated each participant in Experimental group a standard 30-min lecture and hands- on practice for chest compression without ventilation using manikin on the floor according to 5-6cm or 6-7cm chest compression depth
16129796|NCT01936389|Drug|AR-12286|
16129797|NCT01936363|Drug|Pimasertib once daily|Pimasertib administered as oral capsule at a dose of 60 milligram (mg) once daily until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.
16129798|NCT01936363|Drug|Pimasertib placebo|Placebo matching Pimasertib administered once daily in evening until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.
16129799|NCT01936363|Drug|SAR245409 placebo|Placebo matching SAR245409 administered once daily in morning until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.
16129800|NCT01936363|Drug|SAR245409|SAR245409 administered as oral capsule at a dose of 70 milligram (mg) once daily until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.
16129801|NCT01936363|Drug|Pimasertib twice daily|Pimasertib administered as oral capsule at a dose of 60 milligram (mg) twice daily until disease progression, death, intolerable toxicity or withdrawal of informed consent, whichever came first.
16129802|NCT01936350|Drug|Sildenafil|The intervention in this group is the use of sildenafil 50mg; this group will take placebo and will be evaluated by cardiac magnetic resonance before and after the oral use of the drug.
16129803|NCT01936350|Drug|Placebo|This group will use placebo; this group will take placebo and will be evaluated by cardiac magnetic resonance before and after the oral use of the placebo pill.
16129804|NCT01936337|Drug|DLX105 Hydrogel|topical administration on psoriatic plaque
16129805|NCT01936337|Drug|Placebo|topical administration on psoriatic plaque
16129806|NCT01936324|Drug|Olumacostat Glasaretil Gel, 7.5%|Gel containing Olumacostat Glasaretil
16129807|NCT01936324|Other|Olumacostat Glasaretil Gel, Vehicle|Vehicle (placebo) gel
16129808|NCT01936311|Behavioral|Self-management goal elicitation|The intervention will be a form, given prior to a primary care visit, that allows patients to express a self-management goal (health goal) they would like to work on, and a preferred treatment modality.
16129809|NCT01936298|Device|A-ROM Continuous Passive Rehabilitation|"Half an hour of treatment during the morning with the sequential program (each finger is mobilized individually) and half an hour of treatment during the afternoon with the synchronous program (II-III-IV-V finger are mobilized simultaneously, the thumb individually)."
16129810|NCT01936298|Device|P-ROM Continuous Passive Rehabilitation|"Half an hour of treatment during the morning with the sequential program (each finger is mobilized individually) and half an hour of treatment during the afternoon with the synchronous program (II-III-IV-V finger are mobilized simultaneously, the thumb individually)."
16129811|NCT01936285|Drug|Colchicine 2 mg loading dose; 0.5 mg bid for 5 days|
16129812|NCT01936285|Drug|Placebo|
16129813|NCT01936272|Device|Chhabra Shunt Placement|
16129814|NCT01936272|Procedure|ETV/CPC|
16129815|NCT01936259|Device|Mini Stem|The humeral stem component is manufactured from Ti6Al4V alloy. The taper has a machine finish and accepts the taper adaptor of the humeral head component. The proximal region of the bone-contacting outer surface features a porous coating of plasma-sprayed titanium alloy, while the distal portion is polished. Seventeen stem diameters are available - 4 mm to 20 mm, in 1-mm increments.
16129816|NCT01936259|Device|Nano|The stemless humeral component is manufactured from Ti6Al4V alloy. It consists of a central tapered region and six outer wings. The taper has a machine finish and accepts the taper adaptor of the humeral head component. A small groove is included just below the taper to accept an inserter/impactor. The bone-contacting outer surface features a porous coating of plasma-sprayed titanium alloy for cementless fixation in the proximal humerus. Six sizes are available - 30 mm, 32 mm, 34 mm, 36 mm, 38 mm, and 40 mm.
16129817|NCT01936246|Dietary Supplement|Increased protein|
16129818|NCT01936233|Drug|Aspirin|Aspirin 0.1 QD po
16129819|NCT01936233|Drug|Lamivudine|LAminvudine 0.1 QD po
16129820|NCT01936220|Behavioral|Continuity of specialized care|Continuity of care in treatment and professional caregiver was given during 5 year. Treatment targets included relapse prevention through recognition of prodromal symptoms, coping with negative symptoms and stress, increasing medication adherence, decrease of substance use, prevention of drop-out and stimulating and supporting participation in structural activities (work and/or education).
16129821|NCT01936220|Behavioral|Parent groups combined with Continuity of Specialized care|Approximately fifty parent group therapy sessions will be held in a flexible way over a 60 month period. Each parent group was run by two experienced family therapists.
16129886|NCT01935869|Drug|Vehicle|
16129887|NCT01935869|Drug|Petrolatum ointment|
16129822|NCT01936220|Behavioral|Discontinuity of care, non specialised care|Standard Treatment as usual (TU) was provided during 5 years by local mental health care professionals situated nearby the domicile of patients. TU had comparable treatment targets as ST but was not provided by treatment staff specialized in early intervention in schizophrenia or related disorders. However, TU was (like ST) sustained and dedicated to prevent psychotic relapse and improve social functioning.
16129823|NCT01936194|Dietary Supplement|DHA+EPA|
16129824|NCT01936194|Dietary Supplement|High Olive Oil|
16129825|NCT01936194|Dietary Supplement|DHA|
16129826|NCT01936181|Drug|Remicade (infliximab)|
16129827|NCT01936181|Drug|SB2 (proposed biosimilar to infliximab)|
16129828|NCT01936168|Device|Mechanochemical Endovenous Ablation (MOCA)|Mechanochemical Endovenous Ablation (MOCA)for treatment of great saphenous vein incompetence
16129829|NCT01936168|Procedure|Radiofrequency ablation (RFA)|Radiofrequency ablation (RFA)for treatment of great saphenous vein incompetence
16129830|NCT01936155|Device|Custom-built, two-channel stimulator|Custom-built, two-channel stimulator for stimulation of the soleus calf muscle
16129831|NCT01936142|Device|Use of RenalGuard|
16129832|NCT01936129|Drug|Copaxone|
16129833|NCT01936129|Drug|Placebo (buffered normal saline w/v)|
16129834|NCT01936116|Device|sonohysterography with inflated catheter in uterine cavity|during the procedure of sonohysterography balloon catheter is inflated in the uterine cavity
16129835|NCT01936116|Device|sonohysterography with inflated catheter in cervical cavity|During the procedure of sonohysterography balloon catheter is inflated in the cervical canal
16129836|NCT01936103|Drug|standard group|standard statin treatment:Atorvastatin statins 20mg / night .
16129837|NCT01936103|Drug|intensive group|intensive statin treatment： Admission atorvastatin statins the 80mg, after surgery，atorvastatin 40mg / night，and until 30 days after the operation
16129838|NCT01936090|Drug|Bortezomib|Given IV
16129839|NCT01936090|Radiation|Total-Body Irradiation|Undergo TBI
16129840|NCT01936090|Drug|Melphalan|Given IV
16129841|NCT01936090|Procedure|Autologous Bone Marrow Transplantation|Undergo autologous bone marrow transplant
16129842|NCT01936090|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo autologous peripheral blood stem cell transplant
16129843|NCT01936090|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo autologous peripheral blood stem cell transplant
16129844|NCT01936090|Other|Laboratory Biomarker Analysis|Correlative studies
16129845|NCT01936077|Drug|Recombinant LH (Luveris)|150 IU recombinant LH daily.
16129846|NCT01936064|Dietary Supplement|Jobelyn + Cyclophosphamide-Epirubicin6|Jobelyn (dietary Supplement) to be used with Cyclophosphamide-Epirubicin6
16129847|NCT01936064|Drug|Placebo + Cyclophosphamide - Epirubicin 6|Routine drugs for the treatment of breast cancer to be used with Placebo
16129848|NCT01936038|Other|CPAP|CPAP
16129849|NCT01936038|Procedure|Upper Airway Toning for Improve the Compliance of CPAP|Upper Airway Toning for Improve the Compliance of CPAP
16129850|NCT01936025|Drug|Dextromethorphan|
16129851|NCT01936025|Drug|Sitagliptin|
16129852|NCT01936025|Drug|Placebo|
16129853|NCT01936012|Drug|Lisinopril 10 mg tablets of PT Dexa Medica|Each tablet contains 10.89 mg of lisinopril dihydrate that equal to 10 mg lisinopril. Test product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.
16129854|NCT01936012|Drug|Lisinopril 10 mg tablets of PT Boehringer Ingelheim Indonesia|Each tablet contains 10.89 mg of lisinopril dihydrate that equal to 10 mg lisinopril. Reference product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.
16129855|NCT01935999|Device|One piece closed pouch|A one piece closed pouch for the collection of stool from a colostomy stoma
16129856|NCT01935986|Dietary Supplement|probiotic|
16129857|NCT01935986|Dietary Supplement|placebo|
16129858|NCT01935973|Other|Laboratory Biomarker Analysis|Correlative studies
16129859|NCT01935973|Drug|Trametinib|Given PO
16129860|NCT01935973|Drug|Uprosertib|Given PO
16129861|NCT01935960|Other|Laboratory Biomarker Analysis|Correlative studies
16129862|NCT01935960|Other|Pharmacological Study|Correlative studies
16129863|NCT01935960|Other|Placebo|Given PO
16129864|NCT01935960|Drug|Retinoid 9cUAB30|Given PO
16129865|NCT01935947|Drug|Azacitidine|Given SC
16129866|NCT01935947|Drug|Azacitidine|Given PO
16129867|NCT01935947|Drug|Docetaxel|Given IV
16129868|NCT01935947|Drug|Entinostat|Given PO
16129869|NCT01935947|Drug|Gemcitabine Hydrochloride|Given IV
16129870|NCT01935947|Drug|Irinotecan Hydrochloride|Given IV
16129871|NCT01935947|Other|Laboratory Biomarker Analysis|Correlative studies
16129872|NCT01935947|Drug|Pemetrexed Disodium|Given IV
16129873|NCT01935934|Drug|Cabozantinib S-malate|Given PO
16129874|NCT01935934|Other|Laboratory Biomarker Analysis|Correlative studies
16129875|NCT01935934|Other|Pharmacological Study|Correlative studies
16129876|NCT01935921|Biological|Cetuximab|Given IV
16129877|NCT01935921|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16129878|NCT01935921|Biological|Ipilimumab|Given IV
16129879|NCT01935921|Other|Laboratory Biomarker Analysis|Correlative studies
16129880|NCT01935908|Drug|levetiracetam|
16129881|NCT01935895|Behavioral|Exercise on Blood Pressure Reactivity|To comparison, volunteers randomly underwent 2 experimental sessions separated by 48-72h. The exercise session consisting of 3-laps in a circuit, performing resistance and aerobic exercises: knee extension, bench press, knee flexion, rowing in the prone, squat, shoulder press and five minutes of up to down in a 15cm high step between 75-85% heart rate maximum. Resistance exercise loads used dumbbells to upper body exercises and weights attached on the legs and arms to lower body exercises. Each resistance exercise was performed in 15reps with 50% of one repetition maximum test. Two secs for repetition were performed with rhythmic control. The control session was conducted under the same conditions of the exercise session, with the exception that subjects did not perform exercises.
16129882|NCT01935882|Drug|Artemether-lumefantrine combination|
16129883|NCT01935882|Drug|Artemether-Lumefantrine with a single dose of 0.25mg/kg primaquine|
16129888|NCT01935856|Drug|KHK7580|Oral administration
16129889|NCT01935843|Biological|CART-HER-2|
16129890|NCT01935830|Radiation|[11c] LAAM|intravenous administration of 15-20 mCi of [11c] LAAM.
16129891|NCT01935830|Drug|Ritonavir|Pretreatment with oral ritonavir for 3 days followed by intravenous administration of 15-20 mCI of [11c] LAAM.
16129892|NCT01935830|Drug|Efavirenz|Pretreatment with oral Efavirenz 600 mg orally every night x 14 days followed by intravenous administration of 15-20 mCI of [11c] LAAM.
16129893|NCT01935817|Drug|Silybin 94 mg + vitamin E 90 mg + phospholipids 194 mg complex|
16129894|NCT01935817|Drug|Placebo|
16129895|NCT01935804|Drug|Pioglitazone|30 mg/daily for 12 months
16129896|NCT01935804|Drug|Metformin|850 mg/daily for 12 months
16129897|NCT01935791|Other|Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Vehicle|Temperature
16129898|NCT01935791|Drug|Period 1 Visit 1 - Cold PET-CT Vehicle, Visit 2 -Warm PET-CT Glucagon|Hormone
16129899|NCT01935791|Other|Period 1 Visit 1 - Cold PET-CT Vehicle, no visit 2 as BAT negative|Temperature
16129900|NCT01935791|Drug|Period 2 - Visit 1 Warm Control vehicle, Visit 2 Warm Glucagon, Visit 3 Cold control|Hormone
16129901|NCT01935791|Drug|Period 2 - Visit 1 Warm Glucagon, Visit 2 Cold control , Visit 3 Warm control|Hormone
16129902|NCT01935791|Drug|Period 2 -Visit 1 cold control, Visit 2 warm control, Visit 3 Warm glucagon|hormone
16129903|NCT01935791|Drug|Period 2 -Visit 1 cold control, visit 2 warm glucagon, visit 3 warm control|hormone
16129904|NCT01935791|Drug|Period 2- Visit 1 Warm glucagon, visit 2 warm control, visit 3 cold control|hormone
16129905|NCT01935791|Drug|Period 2 - Visit 1 Warm control, visit 2 cold control, visit 3 warm glucagon|Hormone
16129906|NCT01935778|Drug|Docetaxel and capecitabine and oxaliplatin|Docetaxel 60 mg/m² IV Day 1 Capecitabine 800 mg/m² bid (Day 1-Day 14) Oxaliplatin 100 mg/m² IV Day 1
16129907|NCT01935778|Drug|capecitabine and oxaliplatin|Capecitabine 1,000 mg/m² bid(D1-14) Oxaliplatin 130 mg/m² IV Day 1
16129908|NCT01935765|Other|Polysomnography|Diabetes people: Examination diagnosis of the sleep apnea A night at the hospital
16129909|NCT01935765|Other|Evaluation of the autonomous nervous system|blood pressure, Heart frequence, deep breath, Orthostatism, Vasalva, Low blood pressure orthostatic
16129910|NCT01935765|Other|Clinical examination of the sleep|Functional signs, collection of medical histories and associated pathologies, Pittsburgh Sleep Quality Index PSQI, Functional Outcomes of Sleep Questionnaire FOSQ, Epworth Sleepiness Scale ESS, Hospital Anxiety and Depression scale HAD
16129911|NCT01935765|Other|Clinical examination of diabetology|history of diabet, observance, ophthalmological, renal, macroangiopathic and neuronal complications, Toronto scale, Diabetes Quality of Life (DQOL) Questionnaire
16129912|NCT01935765|Other|Biological dosages|Hematology, glycemia, lipids, CRP, creatinine, ferritin, glycosylated hemoglobin, transaminase, microalbuminuria, urine test
16129913|NCT01935765|Other|Electrocardiogram (ECG)|Electrocardiogram (ECG)
16129914|NCT01935765|Other|Carotid echography|Carotid echography
16129915|NCT01935765|Other|Blood pressure|Blood pressure
16129916|NCT01935752|Other|blood samples|blood samples
16129917|NCT01935752|Other|vascular echotracking|endothelial function study and virtual histology study
16129918|NCT01935713|Drug|Nicotine polacrilex|Participants were given the choice of 2mg or 4mg lozenges depending on how many cigarettes per day they reported to smoke.
16129919|NCT01935713|Drug|Electronic Cigarette|Participants were given an e-cigarette starter kit, charging case, and cartridges in either 12mg or 16 mg nicotine, depending on their current amount of cigarettes smoked per day.
16129920|NCT01935713|Drug|Dissolvable Tobacco Lozenge|Participants were given Ariva (light to moderate smokers) or Stonewall (heavier smokers, >2 packs per day).
16129921|NCT01935700|Drug|Colchicine|"Adjustment the dosage of colchicine during study:
~The colchicine dosage will be changed when the hepatic reserved function of the participant changes from Child A to B according as following: 2 tablets after breakfast, 1 tablet after lunch and 2 tablets after dinner; continue 4 days and stop for 3 days (1 cycle); repeat this cycle until patients quit this trial. If the hepatic reserved function of the participant changes to Child C, colchicine will be stopped and participant receives regular follow-up only.If participant suffers from severe diarrhea, colchicine will be temporarily stopped. When the symptom of diarrhea subsides, colchicine will be given again but the dose will be reduced 0.5 mg/day."
16129922|NCT01935687|Device|Using of instrumented wheel|Using of instrumented wheel
16129923|NCT01935687|Device|Using of ergometer roller|Using of ergometer roller
16129924|NCT01935674|Drug|Switch ritonavir-boosted PI|Switch their existing ritonavir-boosted PI to another potent ART drug with lesser effects on serum cholesterol selected by the investigator.
16129925|NCT01935674|Drug|Continue Ritonavir-boosted PI+Rosuvastatin|Continue ritonavir-boosted PI-based ART and commence rosuvastatin 10 mg daily (5 mg daily in Asian participants).
16129926|NCT01935648|Drug|Ropivacaine|
16129927|NCT01935635|Biological|HPDCs-T immune therapy|HPDCs-T immune therapy:one time every 2 weeks during 12 weeks to 36 weeks, IV (in the vein), about 2*105-1*106 cells per time,total 12 times;
16129928|NCT01935622|Drug|Doxycycline|Doxycycline 1 tablet every 12 hours for 14 days
16129929|NCT01935622|Drug|placebo|Placebo 1 tablet every 12 hours for 14 days
16129930|NCT01935609|Behavioral|Couples counseling|Intervention to promote couples' adjustment (TCI) - The TCI was developed based upon considerable clinical experience and research review. The TCI is a structured approach to helping couples after brain injury address issues related to relationship quality and emotional well-being. The TCI is implemented in five or six (optional parenting session) session. Each session is in-person and lasts for 120 minutes.
16129931|NCT01935596|Drug|ropivacaïne|spinal anesthesia.
16129932|NCT01935596|Drug|lévobupivacaïne|
16129933|NCT01935583|Behavioral|Resilience/Adjustment Counseling|Intervention to promote individual's resilience and adjustment (RAI) - The RAI is a structured approach to helping individuals after brain injury address issues related to resilience and adjustment. The RAI is implemented in seven sessions. Each session is in-person and lasts for 60 minutes.
16129934|NCT01935570|Drug|Magnesium chloride (ChronoMag Smart Tablet®)|
16129935|NCT01935570|Drug|Magnesium carbonate (Mag2® Tablet)|
16130271|NCT01932697|Radiation|Hyperfractionation|Undergo hyperfractionated IMRT
16129936|NCT01935557|Drug|Continuous heparin infusion|continuous group is given an initial intravenous heparin 100u/kg and then maintain heparin infusion during procedural.
16129937|NCT01935557|Drug|Intermittent heparin infusion|Intermittent group is given an initial intravenous heparin 100u/kg. Then The ACT is tested every 30min with administration of additional heparin boluses and titration of the heparin drip based on the results and according to the judgment of the operating physician.
16129938|NCT01935544|Device|Botulinum toxin injection|
16129939|NCT01935531|Drug|3% diclofenac in 2.5% hyaluronic acid gel|
16129940|NCT01935518|Drug|Fasudil|All the patients will take the fasudil treatment for 14 days (30mg twice a day, intravenous). 3 months later they will repeat the treatment mentioned before.
16129941|NCT01935505|Behavioral|Consulting|The physicians adopted a non-directive approach, included the five 'A' (ask, advice, assess, assist and arrange), assessing the stage of readiness in quitting smoking, strengthening clients' motivation to quit smoking using the five 'R' (relevance, risks, rewards, roadblocks and repetition) approach, and providing advice to overcome psychological craving, psychological dependence and social-cultural factors associated with tobacco dependency. Each smoker takes more than 30 min to complete the intervention.
16129942|NCT01935505|Drug|Nicotine patch|According to the smokers' level of nicotine dependency, disease history, cigarette consumption, prescription of drugs were provided, Nicotine Replacement Therapy, bupropion and varenicline.
16129943|NCT01935505|Behavioral|Telephone intervention|Smokers received follow-up by a counselor at 1 week, 1, 3, 6 months and 1, 2 years using a detailed questionnaire by telephone interview. At each follow-up, we collected data, asked whether the smokers have any problem with drug use or other problems, provided problem-oriented suggestions or advice as appropriate, encouraged them to insist.
16129944|NCT01935505|Behavioral|Consulting+Telephone+Drug intervention|Include all the above interventions
16129945|NCT01935492|Drug|Paclitaxel, Bevacizumab, liposomal doxorubicin, Capecitabine|"st line:
~Paclitaxel and bevacizumab: 8 cycles, unless PD or unacceptable toxicity occurs earlier.
~Bevacizumab until PD or unacceptable toxicity
~At PD patients will go to the 2nd treatment line.
~nd line:
~Non-pegylated liposomal doxorubicin (Myocet®) (or capecitabine): 8 cycles, unless PD or unacceptable toxicity occurs earlier.
~At PD patients will go to the 3rd treatment line. If possible, it is advised to cross-over from 2nd line non-pegylated liposomal doxorubicin to 3rd line capecitabine."
16129946|NCT01935492|Drug|Paclitaxel, Bevacizumab, liposomal doxorubicin, Capecitabine|"Arm B
~st line
~Paclitaxel and bevacizumab: 4 cycles, unless PD or unacceptable toxicity
~Bevacizumab until PD or unacceptable toxicity
~At PD < 3 months after last paclitaxel start 2nd treatment line.
~At PD ≥ 3 months after last paclitaxel, start another 4 cycles
~Bevacizumab until the next PD or unacceptable toxicity
~At the next PD start the 2nd treatment line.
~nd line:
~Myocet® or capecitabine: 4 cycles, unless PD or unacceptable toxicity
~At PD < 3 months start the 3rd treatment line. If possible, advised to cross-over from 2nd line Myocet® to 3rd line capecitabine.
~At PD ≥ 3 months after last administration of Myocet® or capecitabine, start another 4 cycles of Myocet® or capecitabine
~At the next PD start 3rd treatment line."
16129947|NCT01935479|Drug|AK159|transdermal administration of teriparatide acetate
16129948|NCT01935479|Drug|MN-10-T|subcutaneous administration of teriparatide acetate
16129949|NCT01935479|Drug|Placebo|Placebo AK159
16129950|NCT01935466|Drug|Pioglitazone|Ever users of Pioglitazone
16129951|NCT01935453|Biological|Recombinant hGM-CSF Herpes Simplex Virus Injection|
16129952|NCT01935440|Behavioral|Prevention & Testing|6 group sessions, 1 individual session, and 1 dyad session
16129953|NCT01935440|Behavioral|Prevention & Testing Control|7 group sessions
16129954|NCT01935414|Device|geko™ post-surgery for 48hrs then 4hrs/day until discharge.|
16129955|NCT01935414|Device|TEDS post-surgery for 48hrs then 4hrs/day until discharge.|
16129956|NCT01935388|Other|Common canister|Drug administration via a shared canister with a standardized cleaning protocol.
16129957|NCT01935375|Behavioral|CNM Interpersonal Psychotherapy|Eight Weekly 50 minute sessions CNM Interpersonal Psychotherapy
16129958|NCT01935375|Behavioral|Treatment as Usual|Treatment as Usual is psychotherapy provided by a mental health provider
16129959|NCT01935362|Dietary Supplement|Citrus supplement|
16129960|NCT01935362|Dietary Supplement|Placebo|
16129961|NCT01935336|Drug|Ponatinib|Ponatinib 45mg taken by mouth each day at the same time with or without food
16129962|NCT01935323|Other|High Intensity Interval Training|
16129963|NCT01935323|Other|Moderate Intensity Training|
16129964|NCT01935310|Drug|Imiquimod|"From the group of subjects who met the inclusion criteria, 22 people were selected randomly (using a random number table) since a 20-25% loss to follow up was calculated and the least amount of patients needed were 17.
~During the study participants applied imiquimod cream 5% (Virosupril ® laboratories Roemmers) in the periocular area during the night, three times a week, on nonconsecutive days, for 12 weeks (3 months). If patients presented irritative dermatitis a topical 0.05% desonide cream was administered and applied for less of 5 days until symptoms improved."
16129965|NCT01935297|Behavioral|Exercise|endurance and resistance exercise 3x/week for 8 weeks
16129966|NCT01935271|Dietary Supplement|Muscle Armor Supplement|
16129967|NCT01935271|Dietary Supplement|Placebo|
16129968|NCT01935258|Other|Psychosomatic therapy|Psychosomatic therapy delivered by a psychosomatic therapist, consists of a combination of information and education delivery, relaxation therapy and mindfulness, cognitive approaches and activating therapy. This multi-component approach is captured into a protocol in which therapists are able to modify the treatment in order to deliver a tailor-made treatment for patients with MUS.
16129969|NCT01935258|Other|care as usual|usual care of the general practitioner
16129970|NCT01935245|Device|Mini extracorporeal circulation|"Minimal-ECC versus conventional ECC circuits minimise foreign surface-blood interaction and are heparinized from tip to tip. The tubing length has been shortened to decrease crystalloid prime. Cardiotomy suction is minimised, which leads to less fibrinolysis. An active air-removal device is added to the closed circuit.
~The use of minimal ECC has already shown a significant reduction of the systemic inflammatory reaction and less peroperative transfusion of blood products."
16129971|NCT01935245|Device|Conventional extracorporeal circulation|
16129972|NCT01935219|Behavioral|Goal Management Training|9 weeks, 2 hour session/week, 1 hour/day homework (6 days/week), 2 x 0.5 hour sessions with trainer
16129973|NCT01935219|Behavioral|Processing Speed Training|9 weeks, a total of 10 hours of computer-based processing speed training; 60-75 minutes/week
16129974|NCT01935219|Behavioral|Brain Health Workshop|9 weeks, 2 hour session/week, 1 hour/day homework (6 days/week), 2 x 0.5 hour sessions with trainer
16129975|NCT01935206|Drug|Naloxone (2 mg/kg)|
16129976|NCT01935206|Drug|Placebo|
16129977|NCT01935193|Drug|lysine acetylsalicylate|
16129978|NCT01935180|Device|Colonoscopy Cap|4mm transparent cap (Olympus) mounted to the tip of a colonoscope.
16129979|NCT01935167|Drug|DW1029M 600mg|DW1029M 150mg 2 tablets b.i.d
16129980|NCT01935167|Drug|DW1029M 1200mg|DW1029M 300mg 2 tablets b.i.d
16129981|NCT01935167|Drug|Placebo|Placebo 2 tablets b.i.d.
16129982|NCT01935154|Drug|Vx-001|
16129983|NCT01935154|Drug|Placebo|
16129984|NCT01935141|Procedure|Low-Dose IV Contrast|A single intravenous dose of 30 ml of Visipaque (Iodixanol) 320 non-ionic isoosmolar contrast agent will be given for each CT scan.
16129985|NCT01935141|Device|Siemens Sensation 64-MDCT scanner.|The device will be used to perform CT Pulmonary Angiograms
16129986|NCT01935141|Drug|Visipaque 320 non-ionic isoosmolar contrast agent|Single Dose of Intravenous Iodixanol will be administered per CT scan.
16129987|NCT01935128|Drug|Arm 1 Everolimus/Reduced dose tacrolimus|Immunosuppression drug intervention
16129988|NCT01935115|Drug|Propofol|Propofol anesthesia for ECT
16129989|NCT01935115|Drug|Ketamine|Ketamine anesthesia for ECT
16129990|NCT01935089|Drug|Pegylated Interferon alpha 2b|1µg/kg/week
16129991|NCT01935076|Behavioral|Neonatal exposure to maternal obesity|
16129992|NCT01935063|Behavioral|Cognitive Behavioral Couple Therapy|CBCT includes the following: (1) re-conceptualize PVD as a multidimensional pain problem influenced by a variety of factors including thoughts, emotions, behaviors and couple interactions; (2) re-conceptualize PVD as a couple problem in which both members of the couple affect and are affected by the pain; (3) modify those factors associated with pain during intercourse with a view to increasing adaptive coping, for example, by increasing self-efficacy and decreasing catastrophizing, as well as decreasing pain intensity; (4) improve the quality of sexual functioning, reduce sexual distress and increase sexual satisfaction; (5) consolidate skills.
16129993|NCT01935063|Other|Topical Lidocaine|Nightly applications of a 5% lidocaine ointment on the vulvar vestibule, at the entry of the vagina (50mg/g, Xylocaïne®, AstraZeneca, tube of 35g) for 12 weeks, as described by Zolnoun et al. (2003). In addition, the cream will be applied to a cotton ball kept on the vestibule via the participant's underwear overnight to ensure a continued 7 to 8-hour contact between the anesthetic and the vestibule. A pamphlet with figures detailing how to apply the cream will be given to participants, in addition to a calibrated measurement tool to ensure that all participants apply the same quantity every night.
16129994|NCT01935050|Behavioral|Guided Cognitive-Behavioral Self-Help|Participants will complete the study treatment at home. Bi-weekly telephone support will be provided by study staff.
16129995|NCT01935024|Other|Personalized Exercise Regimen|All exercise regimens include a stationary bicycle.
16129996|NCT01935011|Other|PD, DBS|PD DBS frequency on swallowing function
16129997|NCT01934972|Other|CR + DCS (D-cycloserine)|CR + DCS
16129998|NCT01934972|Other|CR + placebo|CR + placebo
16129999|NCT01934959|Drug|Bifico|
16130000|NCT01934946|Other|comprehensive rehabilitation|received 14 days hospitalization for comprehensive rehabilitation
16130001|NCT01934946|Other|home rehabilitation|6 times home rehabilitation services within 3 months
16130002|NCT01934933|Drug|celebrex|
16130003|NCT01934933|Drug|Enbrel|
16130004|NCT01934933|Drug|Enbrel plus Celebrex|
16130005|NCT01934907|Other|Washing of packed RBC by normal saline|
16130006|NCT01934894|Drug|cabazitaxel|
16130007|NCT01934894|Drug|lapatinib|
16130008|NCT01934881|Device|voltage adjustment only|Only voltage will be adjusted in all programming sections.
16130009|NCT01934881|Device|Combined parameters adjustment|More than one parameter, including voltage, frequency and pulse width, will be adjusted in the programming sections.
16130010|NCT01934868|Drug|prolotherapy solution of 20% dextrose|After verifying the anatomy of the lumbosacral spine under ultrasound, a 9cm 22 gauge needle will be used to inject the prolotherapy solution to each of the points specified. In order to view the needle under ultrasound, a needle at least as thick as 22G is required. In order for the prolotherapy injections to be safe, bone must be contacted in order to avoid nerve damage. At each point a total of 1cc prolotherapy solution will be injected.
16130011|NCT01934868|Drug|Epidural Steroid Injection|Prior to the epidural injection a local anaesthetic solution of 1% lidocaine will be injected into the relevant subcutaneous and ligamentous interlaminar space. The injectant solution will be comprised of 80mg methylprednisolone combined with 10mg (2cc) 0.5% bupivicaine. The resulting 4cc will be diluted with another 4cc of normal saline giving a total volume of 8cc. A loss of resistance technique will be used and radiocontrast dye will be injected to verify the placement of the needle prior to injecting the steroid solution.
16130012|NCT01934842|Device|TAP20-C|
16130013|NCT01934842|Device|SAFE-T-FILL|
16130014|NCT01934829|Drug|urea-based cream|"urea-based cream (10% urea; Eucerin) 3 times per day plus best supportive care, starting on day 1 of sorafenib treatment, for a maximum of 12 weeks .
~BSC included the ad libitum use of non-urea-based moisturizing creams, alcohol-free moisturizer and petroleum jelly. Once HFSR occurred, patients were allowed any cream, including urea based creams, as guided by the investigator."
16130015|NCT01934816|Other|Intradermal injections of GLP-1 and its analogues|native GLP-1,Exenatide (Byetta)and Liraglutide (Victoza) will be microinjected at the same visit in no particular order in all study arms
16130016|NCT01934803|Dietary Supplement|Zinc gluconate|Study participants will be randomly assigned to a zinc gluconate or placebo group and will be instructed to take one pill of study medication orally daily for 18 months.
16130017|NCT01934803|Dietary Supplement|Placebo|
16130018|NCT01934790|Drug|Radium-223 dichloride (Xofigo, BAY88-8223)|Participants received intravenous (IV) injection of radium-223 dichloride 50 kBq/kg body weight every 4 weeks up to 6 injections.
16130019|NCT01934777|Drug|Docosahexaenoic Acid plus Vitamin E plus choline|DHA 250 mg plus Vitamin E (39 UI) plus Choline 201 mg
16130020|NCT01934777|Drug|placebo pearls|placebo
16130313|NCT01932385|Other|Best Supportive Care|
16130021|NCT01934751|Other|Delayed Intervention (DI)|Subjects randomized to the DI group will be given a card with the number for the usual Substance Use Service, where they will be seen within 2-4 weeks (standard practice). If they attend the Substance Use Service they will be offered supportive counseling, pharmacotherapy, and information on community treatment resources.
16130022|NCT01934751|Other|Rapid Intervention (RI)|Subjects randomized to the RI group will be seen in the Substance Use Service at within 1-2 days of study enrolment. The Research Assistant will book the appointment and arrange transportation. At the Substance Use Service they will be offered supportive counseling, pharmacotherapy, and information on community treatment resources.
16130023|NCT01934738|Drug|PF-06273340|Tablets, 100 mg TID, 14 days
16130024|NCT01934738|Drug|Placebo|Tablets, TID, 14 days
16130025|NCT01934738|Drug|PF-06273340|Tablets, to be decided dose, TID or titration, 14 days
16130026|NCT01934738|Drug|Placebo|Tablets, TID or titration, 14 days
16130027|NCT01934738|Drug|PF-06273340|Tablets, to be decided dose, TID or titration, 14 days
16130028|NCT01934738|Drug|Placebo|Tablets, TID or titration, 14 days
16130029|NCT01934738|Drug|PF-06273340|Tablets, to be decided dose, TID or titration, 14 days
16130030|NCT01934738|Drug|Placebo|Tablets, TID or titration, 14 days
16130031|NCT01934738|Drug|PF-06273340|Tablets, to be decided dose, TID or titration, 14 days
16130032|NCT01934738|Drug|Placebo|Tablets, TID or titration, 14 days
16130033|NCT01934738|Drug|PF-06273340|Tablets, to be decided dose, TID or titration, 14 days
16130034|NCT01934738|Drug|Placebo|Tablets, TID or titration, 14 days
16130035|NCT01934712|Drug|Faster-acting insulin aspart|Single dose injected subcutaneously (s.c, under the skin)
16130036|NCT01934712|Drug|insulin aspart|Single dose injected subcutaneously (s.c, under the skin)
16130037|NCT01934699|Device|Cardiac ultrasound|Patient will get echocardiographic examination during coronary angiography. 2D-Strain Analysis will be performed based on data of these echocardiographic examination. Only when vitality in the contraction impaired segments will be established based on 2D-Strain Analysis, PCI will be performed.
16130038|NCT01934699|Device|MRI scanner|Coronary angiography on patient will be canceled. Patients will get viability assessment using MRI within the next 7 days. When vitality will be established with MRI, patient will get PCI.
16130039|NCT01934686|Other|No treatment given|Patients will fill out a questionnaire by interview.
16130040|NCT01934673|Other|No treatment given|Patients will fill out a questionnaire by interview.
16130041|NCT01934647|Drug|MK-8892|Single oral capsule with 1 mg, 4 mg, or 8 mg of MK-8892
16130042|NCT01934634|Drug|LCL161|LCL161 (tablets): 300, 600, 1200, or 1800 mg once a week (Day 1, 8, 15) for 3 weeks, every 28 days
16130043|NCT01934634|Drug|Gemcitabine|Gemcitabine IV: 1,000 mg/m2 once a week (Day 1, 8, 15) for 3 weeks, every 28 days
16130044|NCT01934634|Drug|nab-Paclitaxel|nab-paclitaxel IV: 125 mg/m2 once a week (Day 1, 8, 15) for 3 weeks, every 28 days
16130045|NCT01934621|Behavioral|Strategy Training|
16130046|NCT01934621|Behavioral|Attention Control|
16130047|NCT01934608|Behavioral|Refill synch|
16130048|NCT01934595|Dietary Supplement|Beneprotein|The study will compare different protein supplementation amounts to determine if increased protein supplementation in critically ill patients improves outcomes.
16130049|NCT01934582|Drug|UT-15C SR|
16130050|NCT01934582|Drug|treprostinil diethanolamine|Open label study drug.
16130051|NCT01934569|Drug|Pravastatin, midazolam, losartan, omeprazole, caffeine and PF-05089771|PF-05089771 450mg single dose and titration from 150mg BID to 450mg BID Pravastatin 10mg dingle dose, Midazolam 7.5mg single dose, Losartan 25mg single dose, Caffeine 100mg single dose, Omeprazole 20mg single dose
16130052|NCT01934556|Drug|Ranibizumab 0.3 mg intravitreal injection|
16130053|NCT01934556|Device|Guided Laser Photocoagulation|
16130054|NCT01934543|Other|Polyunsaturated fatty acids diet|During 4 weeks, subjects eat a diet high in polyunsaturated fatty acids (percent of total caloric intake: 15.0% from proteins; 50.0% from carbohydrates; 35.0% from fat: 6.0% from saturated fat; 14.4% from monounsaturated fat; 12.6% from n-6 polyunsaturated fat).
16130055|NCT01934543|Other|Saturated fatty acids diet|During 4 weeks, subjects eat a diet high in polyunsaturated fatty acids (percent of total caloric intake: 15.0% from proteins; 50.0% from carbohydrates; 35.0% from fat: 13.4% from saturated fat; 15.3% from monounsaturated fat; 4.0% from n-6 polyunsaturated fat).
16130056|NCT01934530|Procedure|Soft Tissue Grafting|"All patients were treated with infiltration of local anesthetic with vasoconstrictor if noted tolerable by the medical history. Surgeons were then notified if the patient was randomized to the test or control according to a blinded treatment assignment. In both groups, anesthesia was confirmed at the implant site and the palatal donor site if indicated. The recipient bed was then prepared.
~Vertical incisions were made at the defect at line angles and horizontal incisions connected the two vertical releases intrasulcularly without involving the interdental papilla. The flap was reflected as a full thickness flap maintaining the integrity of the collagen attachment with de-epithelialization of papilla to allow for coronal advancement."
16130057|NCT01934504|Procedure|Venipuncture for blood sample collection|Analysis samples from the blood sample collection at specific time points.
16130058|NCT01934491|Behavioral|Cognitive Training A|
16130059|NCT01934491|Behavioral|Cognitive Training B|
16130060|NCT01934452|Drug|sunitinib|50 mg 4/2 ,oral, once a day 4 weeks on and 2 weeks off for 6 months
16130061|NCT01934452|Drug|sunitinib|50 mg 4/2 ,oral, once a day 4 weeks on and 2 weeks off for 6 months
16130062|NCT01934439|Device|30 PAAD treatments|Subjects will don a shirt with pockets at the elbow and shoulder in each of which a muscle vibrator is located. The subject will then place the affected arm in the PAAD. The PAAD will range the affected arm, at the shoulder in the adduction-abduction direction, and at the elbow in the flexion-extension direction. The subject will assist volitionally this motion, and visual feedback of the level of their assistive torque will be provided along with a target torque level. The muscle vibrators will alternate from one side of each of the 2 joints to the other as the motion reverses, vibration always being applied to the lengthening muscles. This treatment will last 30 min in each session.
16130096|NCT01934153|Drug|[14C]Umeclidinium 18.5 mg|Umeclidinium will be supplied as clear, colorless solution, free from visible particulates, single dose, topical solution in clear glass jars. Dosage of 18.5 mg of Umeclidinium per gram is equivalent to 22 mg per gram of the bromide salt.
16130063|NCT01934413|Behavioral|Technology-Enhanced Transitional Palliative Care|The Transitional Care intervention will be initiated within 24 hours after enrollment, and will include initial transitional care planning, daily hospital visits, crisis prevention planning by an experienced Palliative Care nurse. The intervention will continue after the patient is discharged to home or short term skilled nursing facility, and it will involve an in-person visit between 24-48 hours post discharge, weekly virtual visits via iPad and video conference technology, and additional home visits as needed. Care plans established during initial planning will be implemented and adjusted under the guidance of the palliative care nurse delivering the intervention.
16130064|NCT01934413|Other|Usual Standard of Care|Usual care includes routine hospital discharge planning and usual physician care in primary and specialty outpatient clinics post hospital discharge. The PC consulting service provides consulting services in the inpatient setting. There are no standardized, intentional services provided to outpatients by the PC consulting team. Services provided to outpatients may occur sporadically as initiated by the patient. The majority of PC follow-up if any is a single phone call to the patient/caregiver. To account for the time spent and number of contacts made with the intervention group, the control group will be contacted by phone weekly by a non-nurse member of the study team not involved with the intervention, asked to relate what, if any, medically-related events occurred.
16130065|NCT01934374|Behavioral|Task-Oriented Lower Extremity Strengthening Training|"On the 30th day post stroke (D30), the experimental group will start to receive the TOLEST program for four weeks, one hour per session and three sessions per week. The TOLEST focuses on using task-specific circuit training combined with strengthening of bilateral lower limbs.
~The control group will receive equal-dose exercises starting on D30, with the emphasis on stretching and non-functional movements of the affected lower extremity."
16130066|NCT01934361|Drug|buparlisib|Buparlisib administered orally on a continuous daily schedule. Buparlisib is manufactured as 10mg and 50mg hard gelatin capsules.
16130067|NCT01934361|Drug|carboplatin|Carboplatin intravenous infusion will be administered at a dose of AUC 5 in a 21 day cycle (every 3 weeks).
16130068|NCT01934361|Drug|lomustine|Lomustine will be administered as a single oral dose of 100 mg/m² every 6 weeks in a 42 day cycles.
16130069|NCT01934361|Drug|placebo|Placebo will be administered orally on a continuous QD dosing schedule for cycles of 42 days. Buparlisib matching placebo is manufactured as 10 mg and 50 mg hard gelatin capsules.
16130070|NCT01934348|Behavioral|Psychological First Aid|
16130071|NCT01934348|Behavioral|Usual victim advocacy Services|
16130072|NCT01934335|Drug|Vandetanib|
16130073|NCT01934335|Other|Placebo|
16130074|NCT01934322|Other|Case Management|"Furnish specific assistance and to provide referrals for the patients:
~If the social determinants are not adequate, the team will lend assistance for obtaining income entitlements, health insurance coverage if eligible, stable housing, schooling for children, etc.
~If there are mental disturbances, the team will refer to mental health departments inside the hospital, and if necessary, to a psychiatrist, psychologist or general practitioner (GP) out in the community.
~If the patient presents risk behaviors, the team will refer to substance abuse services and links to community services in order to maintain continuity of care.
~In case of somatic problems, the team will find a new GP or make contact with the previous provider, contingent on the patient's consent."
16130075|NCT01934309|Behavioral|TB reminders|The intervention to be studied involves providing clinic-based medical care providers (e.g., nurses, clinical officers, medical officers, consultants) with patient-speciﬁc clinical reminders regarding TB that are generated from a patient's electronic medical record and based on accepted clinical algorithms for TB screening and treatment.
16130076|NCT01934296|Device|Activa PC+S|Surgical implantation of Activa PC+S as one component of a therapeutic DBS system implantation
16130077|NCT01934283|Device|urine folly catheter|
16130078|NCT01934270|Other|Anaerobic Test|To evaluate the secretion of growth hormone in response to anaerobic exercise in children.
16130079|NCT01934257|Other|Marketed milk-based lactose-containing infant formula|
16130080|NCT01934257|Other|Marketed milk-based lactose-free infant formula|
16130081|NCT01934257|Other|Marketed soy-based lactose-free infant formula|
16130082|NCT01934244|Device|NovaSure Endometrial Ablation|The NovaSure Endometrial Ablation device consists of a disposable single-use, conformable bipolar electrode array mounted on an expandable frame that can create a confluent lesion on the entire interior surface area of the uterine cavity. The device is inserted transcervically into the uterine cavity, and the sheath is retracted to allow the bipolar electrode array to be deployed and conform to the uterine cavity. The disposable device works in conjunction with a dedicated NovaSure RF (radio frequency) controller to perform customized, global endometrial ablation.
16130083|NCT01934231|Drug|Amoxicillin-Potassium Clavulanate Combination|The drug is available in two sachets (CVA/AMPC Dry Syrup 0.505 g and CVA/AMPC Dry Syrup 1.01 g). CVA/AMPC Dry Syrup 1.01 g sachet contains 42.9 mg of Potassium Clavulanate and 600 mg of Amoxicillin Hydrate. It is a white to yellowish white powder and has strawberry flavor and it is white to yellowish white suspension when it is suspended before use.
16130084|NCT01934218|Device|Gel-One|
16130085|NCT01934218|Device|PBS|
16130086|NCT01934205|Drug|GSK2140944 (Single dose)|A lyophilized formulation, pale yellow to grayish yellow cake containing 750 mg of GSK2140944 (as free base) per vial, Administered intravenously as a single dose.
16130087|NCT01934205|Drug|GSK2140944 (Multiple dose)|A lyophilized formulation, pale yellow to grayish yellow cake containing 750 mg of GSK2140944 (as free base) per vial, Administered intravenously every 12 hours for 5 doses (3 days).
16130088|NCT01934192|Drug|GSK962040 50 mg|GSK962040 50 mg will be administered once daily enteral dose through NG tube up to 7 days.
16130089|NCT01934192|Drug|Metoclopramide 10 mg|Metoclopramide will be administered IV every 6 h
16130090|NCT01934192|Drug|Placebo NG|Matching placebo once daily enteral dose will be administered through NG tube up to 7 days
16130091|NCT01934192|Drug|Placebo IV|Placebo will be administered IV every 6 hours
16130092|NCT01934179|Other|cytology specimen collection procedure|Undergo blood sample collection
16130093|NCT01934179|Other|laboratory biomarker analysis|Correlative studies
16130094|NCT01934179|Other|questionnaire administration|Ancillary studies
16130095|NCT01934166|Drug|Nalmefene 18 mg|One single oral dose of 18 mg
16130097|NCT01934140|Biological|Meningococcal vaccine GSK134612|1 dose administered intramuscularly in the non-dominant deltoid region.
16130098|NCT01934127|Biological|Investigational H7N1 vaccine GSK2789869A|One dose of GSK2789869A H7N1 vaccine administered intramuscularly at the deltoid region of the non-dominant arm at Day 0 while second dose of GSK2789869A H7N1 vaccine administered intramuscularly at the deltoid region of the dominant arm at Day 21
16130099|NCT01934127|Biological|Investigational H7N1 vaccine GSK2789868A|One dose of GSK2789868A H7N1 vaccine administered intramuscularly at the deltoid region of the non-dominant arm at Day 0 while the second dose of GSK2789868A H7N1 vaccine administered intramuscularly at the deltoid region of the dominant arm at Day 21
16130100|NCT01934127|Biological|Placebo|One dose of placebo administered intramuscularly at the deltoid region of the non-dominant arm at Day 0 while the second dose of placebo administered intramuscularly at the deltoid region of the dominant arm at Day 21
16130101|NCT01934101|Drug|CHR-5154|CHR-5154
16130102|NCT01934101|Drug|Placebo|Placebo
16130103|NCT01934088|Drug|Propofol|
16130104|NCT01934088|Drug|Midazolam|
16130105|NCT01934088|Drug|Fentanyl|
16130106|NCT01934075|Behavioral|Mental health treatment|6 sessions of individual mental health counseling.
16130107|NCT01934062|Procedure|Surgery|"All surgeries performed at Nationwide Children's Hosp. between 1/1/2013 & 7/31/2013.
~--------------------------------------------------------------------------------"
16130108|NCT01934049|Procedure|hip arthroplasty|Every patient with femoral neck fractures must undergo hip hemi-arthroplasty.
16130109|NCT01934049|Drug|Total Intravenous Anesthesia and Peripheral nerve blocks|Every patient receives Peripheral nerve blocks and Total Intravenous Anesthesia with propofol
16130110|NCT01934036|Dietary Supplement|Obex|After concluded the two months of treatment, patients will be follow-up during three months without consumption of Obex.
16130111|NCT01934036|Drug|Placebo|After concluded the two months of treatment, patients will be follow-up during three months without consumption of the placebo.
16130112|NCT01934023|Drug|Varenicline|Champix (Varenicline) is an approved smoking cessation medication
16130113|NCT01934023|Drug|Placebo|
16130114|NCT01934010|Drug|AM-101|AM-101 gel for intratympanic injection
16130115|NCT01933997|Drug|Metadoxine (MG01CI )|
16130116|NCT01933984|Drug|Bronchodilators inhalation|Salmeterol/fluticasone (Seretide Evohaler) 4 puffs plus fenoterol (Berotec)(0.1mg/puff) 4 puffs inhalation when target airway resistance, measured every 8 hours, not met
16130117|NCT01933971|Drug|Filgrastim test|0.3 mg/mL injectable solution in 1 mL vials Manufacturer (Drug Substance): Eurogenetec S.A., B-4102 Seraing, Belgium Manufacturer (Drug Product): Areta International S.r.l., I-21040 Gerenzano, Italy Batch release: Areta International S.r.l., I-21040 Gerenzano, Italy Route of administration: subcutaneous
16130118|NCT01933971|Drug|Filgrastim reference|"0.3 mg/mL injectable solution in 1 mL vials Licensed owner: Dompé farmaceutici S.p.A., Milan, Italy Manufacturer (Drug Product): Hoffmann - La Roche Ltd., Basel, Switzerland and Amgen Manufacturing Limited, Puertorico.
~Batch release: Amgen Europe B.V., Breda, Netherlands Route of administration: subcutaneous"
16130120|NCT01933945|Procedure|TACE (transarterial chemoembolization)|First treatment for all patients included in the study
16130121|NCT01933945|Drug|Sorafenib (Nexavar, BAY43-9006)|
16130122|NCT01933932|Drug|Selumetinib|Three 25 mg selumetinib capsules (Hyd-Sulfate) be administered orally, twice daily, (total dose 75 mg dose bd) on an uninterrupted schedule.
16130123|NCT01933932|Drug|Docetaxel|Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.
16130124|NCT01933932|Drug|Placebo|Three placebo capsules will be administered orally uninterrupted twice daily in combination with docetaxel 75 mg/m2 intravenously administered on day 1 of each 21 day cycle.
16130125|NCT01933932|Drug|Pegylated G-CSF|All patients will receive pegylated Granulocyte Colony Stimulating Factor (G-CSF) at least 24 hours after administration of every docetaxel dose and not within 14 days prior to the next docetaxel administration.
16130126|NCT01933919|Drug|Fluvoxamine maleate|Film-coated tablet containing 25 mg of fluvoxamine maleate
16130127|NCT01933919|Drug|Placebo|Placebo tablet matching to fluvoxamine maleate
16130128|NCT01933906|Drug|P1101|
16130129|NCT01933880|Drug|Osmotic Release Oral System Methylphenidate Hydrochloride (OROS-MPH)|Osmotic release oral system methylphenidate hydrochloride (OROS-MPH) starting at initial dosage of 18 milligram per day (mg/d) which can be increased to 36mg/d up to a maximum dosage of 54mg/d according to the therapeutic effect and tolerance or maintained at 36 mg or re-adjusted to 18mg due to intolerance.
16130130|NCT01933880|Other|No intervention|Participants did not receive any study drug in this group. Participants were assessed for changes in the cognitive functions and the efficacy was compared with ADHD children.
16130131|NCT01933867|Procedure|Water immersion|Water immersion means infusion of room temperature water during colonoscope insertion without air insufflation.
16130132|NCT01933867|Procedure|Air insufflation insertion|
16130133|NCT01933841|Device|TOF-Watch SX|As part of standard care, patients who undergo intraoperative neuromuscular blockade will have their TOF ratio measured and recorded during their first 10 minutes in the PACU by perioperative nursing staff.
16130134|NCT01933841|Procedure|Notify the provider|"Based on the TOF reading, the patient's PACU nurse will page the provider who administered the block and/or a designated Reversal Support team member. The page will identify the patient and notify the provider of the suboptimal TOF ratio."
16130135|NCT01933828|Procedure|OPEN lobectomy|Lobectomy and mediastinal lymph node dissection by thoracotomy with rib-spreading.
16130136|NCT01933828|Procedure|VATS lobectomy|Thoracoscopic minimally invasive lobectomy with thoracoscopic mediastinal lymph node dissection without rib-spreading.
16130137|NCT01933828|Device|ROBOT-assisted lobectomy|Robot-assisted lobectomy with mediastinal lymph node dissection (Robot group as clinical assignment in prospective Cohort).
16130138|NCT01933815|Drug|TPI 287|TPI 287 is a microtubule inhibitor belonging to the taxane diterpenoid (taxoid) family, and specifically to the abeotaxane class. TPI 287 is an Investigational Drug.
16130193|NCT01933373|Procedure|Toupet|Laparoscopic posterior partial fundoplication plus myotomy.
16130194|NCT01933373|Procedure|Dor|Anterior partial fundoplication plus myotomy.
16130139|NCT01933815|Drug|Bevacizumab|Avastin (bevacizumab) is an FDA approved drug indicated for multiple cancers, including as a single agent for GBM for adult patients with progressive disease following prior therapy. Single agent effectiveness is based on improvement in objective response rate; no data is available demonstrating improvement in disease-related symptoms or survival with bevacizumab.
16130140|NCT01933802|Biological|intrathecal administration of autologous MSC-NP|Autologous MSC-NPs administered intrathecally at a dose between 2 and 10 million cells, depending on ex vivo expansion characteristics. Three doses will be administered at 3 month intervals.
16130141|NCT01933789|Behavioral|Communication Feedback Form for Patients with Serious Illness|"The intervention, based on self-efficacy theory, identifies patients' preferences for communication about end-of-life care (EOLC) and barriers and facilitators to this communication, and collates these data into a feedback form. The feedback forms are tailored to each recipient (clinician, patient, family) to support the communication tasks which that recipient will address. Feedback forms are sent to participants prior to the target clinic visit. The primary clinician's form suggests referral to palliative care if there are potentially unmet palliative-care communication needs. All forms include tips to help the recipient respond to communication preferences appropriately."
16130142|NCT01933776|Biological|Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap|0.5 mL, Intramuscular (IM)
16130143|NCT01933776|Biological|Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed Tdap|0.5 mL, Intramuscular (IM)
16130144|NCT01933763|Drug|REGN1193|
16130145|NCT01933763|Other|Placebo|
16130146|NCT01933750|Device|PresVIEW Device Implantation|
16130147|NCT01933737|Device|Kinesio Taping|The Kinesio Taping group (KTG) (n = 31 elderly women) were submitted to the protocol of applying Kinesio Taping for gastrocnemius muscle and the muscles of the median foot. The application of the tapes was bilateral limbs. The subjects were evaluated post-application and 48 hours after application of the tape.
16130148|NCT01933737|Device|3M Micropore|The placebo tape group (PTG) (n = 31 elderly women) were submitted to the protocol of applying placebo tape (3M Micropore) for gastrocnemius muscle and the muscles of the median foot in the same way that KTG. The application of the tapes was bilateral limbs. The subjects were evaluated post-application and 48 hours after application of the tape.
16130149|NCT01933724|Drug|5 mg prednisone|Subjects will be randomized to take 5 mg per day of prednisone for a 6 month period.
16130150|NCT01933724|Drug|0 mg prednisone|Subjects will be randomized to taper their prednisone dose to no prednisone for a 6 month period.
16130151|NCT01933711|Drug|rituximab|
16130152|NCT01933698|Drug|amoxicillin|Comparison of pharmacokinetics of both formulations
16130153|NCT01933685|Biological|AIDSVAX B/E|1 mL per injection (300 ug dose/antigen for a total of 600 ug/dose administered)
16130154|NCT01933685|Biological|AIDSVAX B/E Placebo|1 mL per injection
16130155|NCT01933672|Drug|PF-04937319 once-daily|Tablets, 300 mg once-daily with breakfast, 14-days
16130156|NCT01933672|Drug|PF-04937319 split-dose|tablets, 150 mg with breakfast plus 100 mg with lunch, 14-days
16130157|NCT01933672|Drug|Sitagliptin once-daily|tablets, 100 mg once-daily with breakfast, 14-days
16130158|NCT01933659|Drug|DSW|ingesting DSW 200 cc four times a day (one hour before meal and bed time)
16130159|NCT01933633|Behavioral|Exercise|
16130160|NCT01933607|Device|TOPS System|Non-randomized study involving implantation of a TOPS via lumbar surgery to decompress and provide stability to the index level.
16130161|NCT01933594|Drug|Romidepsin|RMD administered over 4 hours via an intravenous (IV) catheter.
16130162|NCT01933594|Drug|Placebo for Romidepsin|Placebo for RMD administered over 4 hours via an IV catheter.
16130163|NCT01933568|Radiation|SABR|combined CFRT and SABR with concurrent cisplatin
16130164|NCT01933568|Drug|Cisplatin|combined CFRT and SABR with concurrent cisplatin
16130165|NCT01933555|Behavioral|Empowerment Program|
16130166|NCT01933542|Drug|Placebo|Two placebo tablets identical to the chlorzoxazone tablets.
16130167|NCT01933542|Drug|Chlorzoxazone|Two 250 mg chlorzoxazone tablets
16130168|NCT01933542|Drug|Morphine|Patient controlled intravenous morphine (PCA-pump), bolus 2.5 mg, lock-out-time 10 minutes. Concentration : Morphin 1 mg/ml.
16130169|NCT01933542|Drug|Zofran|Zofran 4 mg iv. in case of moderate to severe nausea, supplemented by Zofran 1 mg iv. if needed
16130170|NCT01933529|Drug|ARA 290|ARA 290 is injected s.c. once daily during the study period
16130171|NCT01933516|Drug|GP2013|GP2013
16130172|NCT01933503|Drug|OCA 5 mg|
16130173|NCT01933503|Drug|OCA 10 mg|
16130174|NCT01933503|Drug|OCA 25 mg|
16130175|NCT01933490|Other|high carbohydrate test meal|
16130176|NCT01933490|Other|high carbohydrate test meal after pre-treatment with rapid acting aspart insulin|
16130177|NCT01933490|Other|high fructose , low glucose test meal with carbohydrate and caloric content similar to the control meal|
16130178|NCT01933477|Other|MCH-focused ART services|Post-partum women who are breast feeding will be retained in the antenatal clinic to receive continued MCH-focused ART services until after the end of breastfeeding and once infants' final HIV status is determined.
16130179|NCT01933464|Drug|Cromolyn Sodium|
16130180|NCT01933464|Drug|Normal Saline|
16130181|NCT01933451|Other|Intraoperative fluid therapy|Intraoperative fluid therapy is directed by pulse pressure variation to a setting value, above 18% or below 13%.
16130182|NCT01933438|Other|Sup-ER Protocol|Early shoulder repositioning (Sup-ER Splint)
16130183|NCT01933438|Other|Control|Standard treatment
16130184|NCT01933425|Drug|rocuronium|
16130185|NCT01933425|Drug|sugammadex|
16130186|NCT01933425|Drug|placebo|
16130187|NCT01933412|Biological|Sci-B-Vac Hepatitis B Vaccine|Sci-B-Vac Hepatitis B Vaccine
16130188|NCT01933412|Biological|Engerix B Hepatitis B Vaccine|
16130189|NCT01933399|Other|Inextensible LSO (stiff back support)|Cotton/nylon canvas back support with velcro fasteners.
16130190|NCT01933399|Other|Extensible LSO, a back support that is flexible|Back support is constructed from lycra and neoprene with velcro fasteners.
16130191|NCT01933399|Other|Standard of Care|Physician visit, physician advice, medications as determined by physician, over the counter medications, and physical therapy.
16130192|NCT01933386|Device|SoundBite|Non-surgical removable bone conduction device via the teeth.
16130195|NCT01933360|Drug|Misoprostol sublingual, 1h|Misoprostol is administered sublingually 1 hour prior to surgical termination of early pregnancy
16130196|NCT01933360|Drug|Placebo sublingual,1h|Placebo for misoprostol is administered sublingually 1 hour prior to surgical termination of early pregnancy
16130197|NCT01933360|Drug|Misoprostol sublingual, 3h|Misoprostol is administered sublingually, 3 hours prior to surgical termination of early pregnancy
16130198|NCT01933360|Drug|Misoprostol vaginal, 1h|Misoprostol is administered vaginally 1 hour prior to surgical termination of early pregnancy
16130199|NCT01933360|Drug|Misoprostol vaginal, 3h|Misoprostol is administered vaginally 3 hours prior to surgical termination of early pregnancy
16130200|NCT01933360|Drug|Placebo sublingual, 3h|Placebo for misoprostol is administered sublingually 3 hours prior to surgical termination of early pregnancy
16130201|NCT01933360|Drug|Placebo vaginal, 1h|Placebo for misoprostol is administered vaginally 1 hour prior to surgical termination of early pregnancy
16130202|NCT01933360|Drug|Placebo vaginal, 3h|Placebo for misoprostol is administered vaginally 3 hours prior to surgical termination of early pregnancy
16130203|NCT01933347|Drug|Gefitinib|Subjects will receive the oral administration of gefitinib 250mg/d until the tumor progression.
16130204|NCT01933334|Drug|Pirfenidone|Pirfenidone will be administered orally at a dose of 267 mg one oral capsule TID (801 mg/day) for 1 or 2 weeks followed by two 267 mg oral capsules TID (1602 mg/day) for 1 or 2 weeks (titration period) and then three 267 mg oral capsules TID (2403 mg/day) for 12 weeks (maintenance period).
16130205|NCT01933321|Biological|Intrathecal autologous stem cell|Mobilization and collection of stem cells for intravenous and intrathecal administration
16130206|NCT01933308|Other|Continuous high intensity training-CT80|Continuous exercise training at 80% of peak work rate Heart rate (HR) response observed at their target training intensity will be identified from an incremental exercise test completed at baseline. Subjects will be asked to train within ±5beats/min of this HR. Subjects will also perform upper-extremity strength training, stretching and relaxation exercises. Overall, sessions will last approximately 2hrs, including cycling (45-60min), strength training (30min), stretching (10min) and relaxation exercises (20min). Sessions will be held on Mondays, Wednesdays and Fridays. Supervision will be provided by clinical exercise physiologists trained by Dr. Pepin. Self-management training (Living Well with COPD®) will be provided by a healthcare practitioner trained by Dr. Lavoie.
16130207|NCT01933308|Other|Training at ventilatory threshold-CTVT|Continuous exercise training at the ventilatory threshold Heart rate (HR) response observed at their target training intensity will be identified from an incremental exercise test completed at baseline. Subjects will be asked to train within ±5beats/min of this HR. Subjects will also perform upper-extremity strength training, stretching and relaxation exercises. Overall, sessions will last approximately 2hrs, including cycling (45-60min), strength training (30min), stretching (10min) and relaxation exercises (20min). Sessions will be held on Mondays, Wednesdays and Fridays. Supervision will be provided by clinical exercise physiologists trained by Dr. Pepin. Self-management training (Living Well with COPD®) will be provided by a healthcare practitioner trained by Dr. Lavoie.
16130208|NCT01933308|Other|Interval training-IT|High intensity interval training Heart rate (HR) response observed at their target training intensity will be identified from an incremental exercise test completed at baseline. Subjects will be asked to train within ±5beats/min of this HR. Subjects will also perform upper-extremity strength training, stretching and relaxation exercises. Overall, sessions will last approximately 2hrs, including cycling (45-60min), strength training (30min), stretching (10min) and relaxation exercises (20min). Sessions will be held on Mondays, Wednesdays and Fridays. Supervision will be provided by clinical exercise physiologists trained by Dr. Pepin. Self-management training (Living Well with COPD®) will be provided by a healthcare practitioner trained by Dr. Lavoie.
16130209|NCT01933295|Behavioral|Cognitive Behavioral Therapy for Insomnia|
16130210|NCT01933295|Behavioral|Sleep Education|
16130211|NCT01933295|Behavioral|Sleep Restriction Therapy|
16130212|NCT01933282|Drug|MESA chemotherapy|Methotrexate 2g/ m2，IV d1 etoposide 100mg/ m2，VD d2，d3，d4， dexamethasone 20mg/ m2，VD d2，d3，d4, d5 Polyehylene glycol-asparaginase muscular injection 2500IU/ m2, d5
16130213|NCT01933282|Drug|MESA|Methotrexate etoposide dexamethasone Polyehylene glycol-asparaginase
16130214|NCT01933269|Drug|FACBC|
16130215|NCT01933256|Drug|HIP2B|
16130216|NCT01933256|Drug|Placebo|
16130217|NCT01933243|Drug|Fish oil|Participants will take 4 capsules daily
16130218|NCT01933243|Drug|Placebo pill|Participants will take 4 capsules daily
16130219|NCT01933230|Device|Excel Cryo Cooling System|"An Excel Cryo Cooling System collar will be place around the neck for two hours. This will cool the blood in the neck that goes to the brain causing the brain to become cool. The collar is a standard neck collar used for patients after neck surgery with a modification that allows for the placement of a cooling pack in the collar. The cooling pack is similar to the cooling packs used for sports injuries. The cooling packs will be changed every 20 minutes for the two-hour duration. During the study and for two hours after, we will collect data concerning the brain temperature, body temperature, brain oxygen level, and pressure both in the head and in the blood.
~2 hour neck cooling period"
16130220|NCT01933217|Drug|Methylphenidate|
16130221|NCT01933217|Drug|Placebo|
16130222|NCT01933204|Other|Acupuncture|Acupuncture is a collection of procedures involving penetration of the skin with needles to stimulate certain points on the body. In its classical form it is a characteristic component of traditional Chinese medicine (TCM), a form of alternative medicine, and one of the oldest healing practices in the world.
16130223|NCT01933204|Drug|Climen 21 Tablets|Climen Tablets are commonly used for menopausal symptoms
16130224|NCT01933191|Behavioral|Aerobic treadmill exercise|Experimental training: Aerobic treadmill exercise (30 minutes, 70% VO2max) prior to an elective minor dental procedures (e.g., extractions, endodontics, apicoectomies, dental restorations, periodontal treatment, dental implants).
16130225|NCT01933191|Behavioral|placebo exercise|placebo exercise: Aerobic treadmill exercise (30 minutes, 20% VO2max) prior to an elective minor dental procedures (e.g., extractions, endodontics, apicoectomies, dental restorations, periodontal treatment, dental implants).
16130226|NCT01933178|Device|Cirrus AS-OCT|
16130227|NCT01933165|Device|LipiView|
16130228|NCT01933152|Drug|Ranibizumab|Patients with wet AMD treated with ranibizumab as prescribed by physician
16130229|NCT01933139|Other|Audio-visual presentation|
16130232|NCT01933113|Device|Deep Brain Stimulation of the Lateral Hypothalamic Area|Deep Brain Stimulation of the Lateral Hypothalamic Area
16130233|NCT01933100|Other|Experimental Diet|Macronutrient composition of experimental diet were carbohydrate 55~70%, protein 7~20%, fat 15~25%, fiber provided by the experimental diet was designed to adequate intake 20g/day for women
16130234|NCT01933087|Behavioral|Hand hygiene promotion|The intervention will adapt from the WHO Multimodal HH Improvement Strategy making use of five components: 1) system change (for example, changing systems to ensure that alcohol-based hand-rub is readily available wherever and whenever needed), 2) training and education, 3) observation and feedback, 4) reminders in the hospital, and 5) a hospital safety climate with the aim of inducing behavioural and cultural change in relation to reduce HCAI and improve HH. The intervention will be delivered to infection control ward nurses (ICWNs) of each ward at each time step by researcher and the infection control team (ICT).
16130235|NCT01933061|Drug|Abraxane|Abraxane 150- mg/m² IV on Days 1, 8, and 15 of a 28-day cycle
16130236|NCT01933061|Drug|Abraxane|Abraxane 150 mg/m^2 intravenously on Days 1, 8, and 15 of a 28-day cycle
16130237|NCT01933048|Drug|FluMist|FluMist Intranasal Vaccine
16130238|NCT01933035|Other|Immune Thrombocytopenics|Full blood count with extended platelet parameters
16130239|NCT01933035|Other|Hypo-proliferative thrombocytopenics|Full blood count with extended platelet parameters
16130240|NCT01933035|Other|Control Population|Full blood count with extended platelet parameters
16130241|NCT01933022|Drug|Eligard|Subcutaneous Injection
16130242|NCT01932996|Drug|nicotine patch plus nicotine gum/lozenge|12-week treatment with nicotine patch plus nicotine gum/lozenge
16130243|NCT01932996|Behavioral|Intensive Alcohol Intervention|Intensive alcohol abstinence counseling using CBT will include weekly individual sessions for 3 months followed by monthly booster group sessions for 3 months
16130244|NCT01932983|Device|Train of four test|TOF test includes stimulation of peripheral nerve of upper extremity, ulnar nerve in this study. Two methods of interpretation are included, visual which uses anesthesiologist TOF device, and quantitative uses intraoperative neurophysiologic monitoring device, both devices are in routine clinical practice use. Different interpretation of muscle contractions are followed, by quantitative method and visual method. Visual evaluates number of twitches and determines the degree of neuromuclular block and percent of blocked acetylcholine receptors. Quantitative method record muscle contraction by using EMG, presents each twitch as amplitude, caluculate peak to peak value, and provide numerical value and difference for each twitch.
16130245|NCT01932970|Drug|Etelcalcetide|Etelcalcetide is provided as a sterile lyophilized powder to be reconstituted with sterile water for injection.
16130246|NCT01932957|Procedure|Laparotomy arm|Laparotomy as standard treatment for ruptured ectopic pregnancy
16130247|NCT01932957|Procedure|Laparoscopy arm|Laparoscopy as treatment for ruptured ectopic pregnancy
16130248|NCT01932944|Device|No treatment|
16130249|NCT01932931|Dietary Supplement|cholecalciferol (50ug)|The aim of the study was to investigate the effect of high dose vitamin D3 supplementation on the muscoloskeletal system among patients treated with antidepressants due to a diagnosis of major depressive disorder
16130250|NCT01932918|Drug|Patient controlled analgesia|"PCA with morphine in liver transplant:
~Intravenous patient controlled analgesia with morphine was used for postoperative pain control in liver transplant recipients.
~PCA with morphine and ketorolac:
~Patient controlled analgesia with morphine and ketorolac was used for postoperative pain control in liver transplant and thoracic surgery patients.
~Intravenous PCA in thoracic surgery Intravenous patient controlled analgesia was used for postoperative pain control in thoracic surgery patients.
~PCEA in thoracic surgery Patient controlled epidural analgesia was used for postoperative pain control in thoracic surgery patients."
16130251|NCT01932905|Device|deep rTMS|Patients undergoing of repetitive transcranial magnetic stimulation for treatment of central pain
16130252|NCT01932879|Other|Blackberry|Participants will be fed a higher fat, typical American diet for two 1-week periods. Participants must consume only and all food provided during the intervention periods.
16130253|NCT01932879|Other|Jello|
16130254|NCT01932866|Other|diabetic risk score|
16130255|NCT01932840|Behavioral|Mock package questionnaire|Within a online questionnaire we exposed participants randomly to 4 mock margarine packages differing only by the claim it carried and asked participants to answer several questions on attitudes and understanding after each mock package.
16130256|NCT01932827|Behavioral|Mock Package Questionnaire|Within a online questionnaire we exposed participants randomly to 4 mock cereal packages differing only by the nutrition claim it carried and asked participants to answer several questions on attitudes and understanding after each mock package.
16130257|NCT01932801|Drug|XR-NTX+HRC|
16130258|NCT01932801|Other|Placebo+HRC|
16130259|NCT01932801|Behavioral|HRC|
16130260|NCT01932788|Drug|Vitamin D3 4000 IU in gummy form|Subjects randomized to the Vitamin D3 4000 IU gummy vitamin arm, the investigational drug, will consume 4 gummies/day beginning at 10-14 weeks of your pregnancy. All subjects will consume a prenatal vitamin (either chewable or pill form) also beginning at 10-14 weeks of your pregnancy.
16130261|NCT01932788|Drug|Placebo gummy vitamin|Subjects randomized to receive placebo, also in gummy form but manufactured without Vitamin D3, will consume 4 gummies/day beginning at 10-14 weeks of pregnancy. All subjects will take a prenatal vitamin (either chewable or pill form) also beginning at 10-14 weeks of pregnancy.
16130262|NCT01932775|Device|GlucoTab System|
16130263|NCT01932762|Drug|Grazoprevir|100 mg every day (QD) orally
16130264|NCT01932762|Drug|Elbasvir|50 mg QD orally
16130265|NCT01932762|Drug|Ribavirin|Administered twice daily (BID) orally at a total daily dose of 800 mg to 1400 mg based on participant's weight on Day 1
16130266|NCT01932749|Device|Transcranial Magnetic stimulation|
16130267|NCT01932736|Other|changing ear canal pressure|ear canal pressure changes: pressure varied from +/-40 decapascals
16130268|NCT01932723|Behavioral|Lumbar stabilization exercises|The functional lumbar stabilization exercises was performed daily, 10 repetitions each, three times a day for three months consecutively.
16130269|NCT01932710|Procedure|White Blood Cell Transfusion|Patient receives white blood cells by vein from a volunteer donor. Each transfusion will take anywhere from 1 hour to several hours, depending on how treatment tolerated. Transfusion received every 3-4 days (at least 2 a week) for up to 6 weeks.
16130270|NCT01932697|Drug|Docetaxel|Given IV
16130272|NCT01932697|Radiation|Intensity-Modulated Radiation Therapy|Undergo hyperfractionated IMRT
16130273|NCT01932697|Other|Laboratory Biomarker Analysis|Correlative studies
16130274|NCT01932697|Other|Quality-of-Life Assessment|Ancillary studies
16130275|NCT01932684|Other|Breath-Stacking|We used a silicone face mask, connected to a unidirectional valve which allowed only inspiration and is connected to a spirometer showed that the volume inspired by the individual. The face mask was attached to the appraised performed successive breaths until the researcher realized the lack of volume of air being inhaled and this time it was allowed to expire (Baker et al., 1990; Feitosa et al., 2012).
16130276|NCT01932684|Other|Incentive spirometry|We used an incentive spirometer volume (5000 Voldyne ® Sherwood Medical, USA). Subjects performed slow, deep inhalations from functional residual capacity to total lung capacity, seeking to sustain the inspiration for at least three seconds (Restrepo et al., 2011).
16130277|NCT01932684|Device|5000 Voldyne ® Sherwood Medical, USA|
16130278|NCT01932684|Device|Silicone face mask|
16130279|NCT01932658|Biological|Hematopoietic stem cell transplantation|Lymphoablation followed by hematopoietic stem cell transplantation to rescue the immune system.
16130280|NCT01932632|Other|Medication Minimization|Series of specific medication reviews done by attending MD using standardized study protocol forms and MD's clinical assessment.
16130281|NCT01932606|Drug|Nitrite|Study drug (NaNO_2 50 mcg/kg/min) will be infused for 5 minutes during the cardiac catheterization procedure.
16130282|NCT01932606|Drug|Saline Placebo for Nitrite|Normal saline placebo will be infused for 5 minutes during the cardiac catheterization procedure. Hemodynamics will then be measured at baseline after study drug infusion and again during low level exercise (20 Watts).
16130283|NCT01932593|Procedure|Infusion of autologous bone marrow|Bone marrow harvest under general anaesthetic and intravenous infusion of filtered but otherwise unselected autologous bone marrow
16130284|NCT01932580|Drug|FLOT (5-fluorouracil, oxaliplatin, docetaxel)|Administration of FLOT chemotherapy before and after surgery
16130285|NCT01932567|Other|Physiotherapy|
16130286|NCT01932567|Procedure|Electrical impedance tomography|
16130287|NCT01932554|Drug|Abciximab|Abciximab will be administered as initial bolus of dose of 0.25 mg/kg, delivered via syringe pump over 15 minutes, followed by a continuous infusion of 0.125 microgram/kg/min (max of 10 micrograms/min) infused over the next 12 hours. Infusion to start within 16 hours of admission. All patients will receive standard supportive care measures.
16130288|NCT01932554|Drug|Placebo|Inactive placebo will be administered as initial bolus followed by a continuous infusion over the next 12 hours, in syringes and volumes identical with the drug administered in the experimental arm. Infusion to begin within 16 hours of admission. All patients will also receive standard supportive care measures.
16130289|NCT01932554|Other|Intravenous hydration|intravenous hydration to provide total fluid intake of 1.25-1.5 times maintenance fluid requirements
16130290|NCT01932554|Drug|Ibuprofen|Scheduled ibuprofen,~10 mg/kg every 6-8 hours
16130291|NCT01932554|Drug|Parenteral narcotic|Parenteral morphine administered by bolus or patient-controlled analgesia to maintain pain control. Hydromorphone or fentanyl will be used in patients who do not tolerate morphine.
16130292|NCT01932554|Other|Incentive spirometry|Patients will perform incentive spirometry every 2 hours while awake
16130293|NCT01932554|Other|Supplemental oxygen|Supplemental oxygen by nasal cannula or mask will be provided if needed to maintain oxygen saturation of 92% or greater.
16130294|NCT01932541|Drug|Latuda (Lurasidone)|Latuda® (lurasidone) tablets taken by mouth once daily, between 20 mg and 120 mg a day.
16130295|NCT01932528|Drug|500 mg [14C]-LX1606|500 mg dose of LX1606 containing a target dose of 3.32 Megabecquerel (MBq) of radiation as [14C]-LX1606.
16130296|NCT01932515|Behavioral|A revised screening instrument for use in Deaf children|
16130297|NCT01932502|Drug|clobazam (Onfi)|"Subject's clonazepam will be converted to the following Onfi doses per day:
~Clonazepam 0.5mg converted to Onfi 10mg first week, then titrated up to 40mg per day.
~Clonazepam 1.0-2.0mg converted to Onfi 20mg first week, then titrated up to 40mg per day.
~Clonazepam 2-4mg converted to Onfi 20mg first week, then titrated up to 60mg per day.
~Initial conversion will occur over two weeks followed by upward titration of up to 10mg increment per week toward the target dose. Down titration of up to 10mg will be allowed during the study.
~The following will be the initial conversion schedule from clonazepam to Onfi:
~Week 1: 50% reduction of clonazepam and starting dose of Onfi, replacing the reduced clonazepam dose with the conversion rate of clonazepam 0.5mg = Onfi 10mg.
~Week 2: Discontinuing clonazepam and increasing the dosage of Onfi by two-fold. Week 3+: Titrate the dose of Onfi up to 40mg per day as tolerated"
16130298|NCT01932502|Drug|Initial conversion and titration|Initial conversion will occur over two weeks followed by upward titration of up to 10mg increment per week toward the target dose. Down titration of up to 10mg will be allowed during the study.
16130299|NCT01932502|Drug|Conversion schedule - Week 1|"The following will be the initial conversion schedule from clonazepam to Onfi:
~Week 1: 50% reduction of clonazepam and starting dose of Onfi, replacing the reduced clonazepam dose with the conversion rate of clonazepam 0.5mg=Onfi 10mg."
16130300|NCT01932502|Drug|Conversion schedule - Week 2|Week 2: Discontinuing clonazepam and increasing the dosage of Onfi by two-fold.
16130301|NCT01932502|Drug|Conversion schedule - Week 3|Week 3+: Titrate the dose of Onfi up to 40mg per day as tolerated.
16130302|NCT01932489|Procedure|Biopsy of a metastatic lesion.|
16130303|NCT01932476|Dietary Supplement|Gluten Challenge|Three-day gluten containing dietary challenge.
16130304|NCT01932476|Dietary Supplement|Sham Challenge|Three-day sham (gluten free) dietary challenge
16130305|NCT01932463|Device|ExAblate Transcranial System|MR Guided Focused Ultrasound
16130306|NCT01932450|Procedure|renal sympathetic denervation|One-time standard Catheter-based renal sympathetic denervation will be performed in both renal arteries by radiofrequency ablation.
16130307|NCT01932450|Drug|antihypertensive drugs|antihypertensive drugs have been used from baseline in patients, and will be modified by patient's blood pressure.
16130308|NCT01932437|Biological|ETI-204|monoclonal antibody
16130309|NCT01932437|Other|Placebo|Placebo for ETI-204
16130310|NCT01932424|Device|Pelorus 1500|a bedside blood propofol measurement device
16130311|NCT01932424|Drug|Propofol 2% (Diprivan 2%, Astra Zeneca UK)|
16130312|NCT01932385|Drug|Sorafenib|
16130314|NCT01932372|Drug|Tofacitinib (Xeljanz)|5 mg Tablet BID
16130315|NCT01932372|Drug|Etanercept, other Biologics, Disease-modifying antirheumatic drugs (DMARDs), etc|Etanercept: 10 to 25 mg twice weekly, or 25 to 50 mg once weekly
16130316|NCT01932359|Other|rapidly absorbable suture (Vicryl Rapide)|
16130317|NCT01932359|Other|non-absorbable suture (Ethilon)|
16130318|NCT01932333|Drug|JNJ-40411813 50 mg|Cohort 1: Participants will receive 50 mg of JNJ-40411813 (2 capsules X 25 mg) once a day on Day 1 in Period 1 and twice a day on Days 1 to 9 and once a day on Day 10 in Period 2 orally (by mouth).
16130319|NCT01932333|Drug|JNJ-40411813 100 mg|Cohort 2: Participants will receive 100 mg of JNJ-40411813 (1 capsule X 100 mg) once a day on Day 1 in Period 1 and twice a day on Days 1 to 9 and once a day on Day 10 in Period 2 orally (by mouth).
16130320|NCT01932333|Drug|Placebo|Cohort 1: Participants will receive placebo once a day on Day 1 for Period 1 and twice a day on Days 1 to 9 and once a day on Day 10 for Period 2; Cohort 2: Participants will receive placebo once a day on Day 1 for Period 1 and twice a day on Days 1 to 9 and once a day on Day 10 for Period 2.
16130321|NCT01932320|Drug|JNJ-40411813: Formulation A|Participants will receive JNJ-40411813 100 mg hard gelatin capsule orally (by mouth) as a single dose for Part 1 (Period 1, Period 2, and Period 3). If selected this formulation from Part 1, participants will receive this formulation at the dose of 50 mg to 150 mg orally without food and with food in Part 2 (Period 1, Period 2); and at the dose of 50 mg to 150 mg orally without food on Day 1 and Day 10 in Part 3.
16130322|NCT01932320|Drug|JNJ-40411813: Formulation B|Participants will receive JNJ-40411813 100 mg immediate release tablet orally as a single dose for Part 1 (Period 1, Period 2, and Period 3). If selected this formulation from Part 1, participants will receive this formulation at the dose of 50 mg to 150 mg orally without food and with food in Part 2 (Period 1, Period 2); and at the dose of 50 mg to 150 mg orally without food on Day 1 and Day 10 in Part 3.
16130323|NCT01932320|Drug|JNJ-40411813: Formulation C|Participants will receive JNJ-40411813 100 mg nanosuspension orally as a single dose for Part 1 (Period 1, Period 2, and Period 3).
16130324|NCT01932320|Drug|Ketoconazole|Participants will receive ketoconazole 200 mg tablet orally twice daily with food from Day 6 to Day 14 in Part 3.
16130325|NCT01932307|Procedure|Neck strengthening exercise program|Study subjects will be introduced to a 2-minute neck strengthening exercise program and advised to follow for 10 weeks. The exercise program will include five different exercises that will strengthen the neck and stabilize the scapula. The exercises are: Chin retraction, cracking the egg, scapular clock, wall pushup and scapula retraction. Each will be completed as 3 isometric holds, 3 repetitions per set and 2 sets per exercise.
16130326|NCT01932281|Dietary Supplement|SierraSil|SierraSil is a natural, mineral supplement currently used to improve joint health and function.
16130327|NCT01932281|Dietary Supplement|Placebo|Sugar pill manufactured to mimic SierraSil 667 mg capsule
16130328|NCT01932268|Drug|Rifampicin|single arm : check a change of Colchicine concentrations from basline at 1,2,4,8,24 hours after Rifampicin administration
16130329|NCT01932255|Procedure|prophylactic spinal tap|
16130330|NCT01932255|Procedure|no prophylactic spinal tap|
16130331|NCT01932242|Biological|ETI-204|Monoclonal Antibody
16130332|NCT01932242|Other|Placebo|Placebo for ETI-204
16130333|NCT01932229|Drug|Afatinib treatment|
16130334|NCT01932216|Procedure|Cholecystectomy|Gallbladder removal
16130335|NCT01932203|Drug|aspirin|100mg once a day
16130336|NCT01932203|Drug|cilostazol|200mg once a day
16130337|NCT01932190|Procedure|Early RRT strategy|"the early strategy : RRT is started immediately when a RIFLE F status is documented"
16130338|NCT01932190|Procedure|Delayed RRT strategy|"The delayed strategy : RRT (in patients who also present RIFLE F renal failure) is started only in case of occurrence of one or more of the Alert Criteria: see summary"
16130339|NCT01932177|Drug|Everolimus and sorafenib|Everolimus will be given alone during a 2 week run-in period before starting sorafenib. Subsequently sorafenib will be administered twice a day while everolimus will be given once a day continuously.
16130340|NCT01932177|Drug|Everolimus and sorafenib|Sorafenib will be given alone during a 2 week run-in period before starting everolimus. Subsequently sorafenib will be administered twice a day while everolimus will be given once a day continuously.
16130341|NCT01932177|Drug|Everolimus and sorafenib|Bid sorafenib will be given every other week alternating with 1 week qd everolimus. Doses will be escalated.
16130342|NCT01932177|Drug|Everolimus and sorafenib|Sorafenib will be given twice a day for 3 days-on 4 days-off while everolimus will be administered continuously on a daily basis. Doses will be escalated.
16130343|NCT01932164|Procedure|maxillary alveolar graft by tissue engineering|Extraction of deciduous teeth of cleft lip and palate patients to obtain mesenchymal stem cells;
16130344|NCT01932164|Procedure|Bone tissue engineering using mesenchymal stem cells|Secondary alveolar graft in patients with cleft lip and palate using using mesenchymal stem cell obtained from dental pulp of deciduous teeth (autogenous) associated with a biomaterial composed of collagen and hydroxyapatite.
16130345|NCT01932151|Drug|Terlipressin and albumin|"Single-group study (Type-1 Hepatorenal Syndrome Associated With Active Infections) Terlipressin was initially given at a dose of 1 mg/4h as an intravenous bolus for 2 days. If at day 3 serum creatinine had decreased at least 25% of the pretreatment values, the dose of terlipressin was not modified. In the remaining patients, the dose was increased up to a maximum of 2 mg/4h. Terlipressin was given until serum creatinine had decreased below 1.5 mg/dL (133 µmol/L) or for a maximum of 14 days.
~In addition to terlipressin, all patients received albumin at a dose of 1g per kg body weight during the first 24 hours, followed by 40g daily,targeted to obtain a central venous pressure (CVP) between 10 and 15 cm of water."
16130346|NCT01932138|Other|Enhanced CHW intervention|"The CHW employed in this study are a health worker cadre that already exists in the Tanzanian public-sector health system, so-called home-base carers (or HBC). The HBC in this study are supervised by another existing cadre, so-called community-based health care workers (or CBHC). The CBHC are clinic-based and are charged to organize community outreach activities in the Tanzanian public-sector health systems. The CBHC (1-2 per clinic) are also active in the control arm; in this intervention arm, there role is changed: they are actively supervising a large number of CHW. Per street (or mtaa), 1-2 CHW are assigned to carry out the enhanced CHW intervention."
16130415|NCT01931514|Drug|Torrent's Montelukast Sodium chewable Tablets 5mg|
16130752|NCT01928901|Drug|administration of Bronchipret|
16130347|NCT01932138|Other|Standard of care|The standard of care in the Tanzanian health care system does not include any CHW intervention to enhance ANC and PMTCT uptake and retention. The only community-based intervention are PMTCT follow-up organized by a health worker cadre who works out of ANC and primary care clinics (so-called CBHC).
16130348|NCT01932125|Drug|Bevacizumab|Participants will receive five cycles of bevacizumab 15 mg/kg concurrently with six cycles of the standard chemotherapy every three weeks (q3w), followed by extended cycles of bevacizumab 15 mg/kg q3w as a single agent for additional 16 cycles. A total of 21 cycles of bevacizumab will be administered in this study.
16130349|NCT01932112|Drug|Adenosine arm|After pulmonary vein isolation,20mg Intracardiac adenosine will be given to treatment group, will evaluate pulmonary vein reconnection.
16130350|NCT01932099|Device|Transcatheter aortic valve replacement|Direct Flow Medical Transcatheter Aortic Valve System is indicated for use in aortic stenosis for patients at extreme surgical risk for aortic valve replacement.
16130351|NCT01932086|Dietary Supplement|White rice diet|All test foods contained 50 g available carbohydrate from the test food products. A glass of 250 ml water was served together with the clinical trial food, and the participants were instructed to ingest the breakfast with 15 min
16130352|NCT01932086|Dietary Supplement|Brown rice diet|All test foods contained 50 g available carbohydrate from the test food products. A glass of 250 ml water was served together with the clinical trial food, and the participants were instructed to ingest the breakfast with 15 min
16130353|NCT01932086|Dietary Supplement|Black rice diet|All test foods contained 50 g available carbohydrate from the test food products. A glass of 250 ml water was served together with the clinical trial food, and the participants were instructed to ingest the breakfast with 15 min
16130354|NCT01932086|Dietary Supplement|Bread|All test foods contained 50 g available carbohydrate from the test food products. A glass of 250 ml water was served together with the clinical trial food, and the participants were instructed to ingest the breakfast with 15 min
16130355|NCT01932086|Other|Glucose solution|All test foods contained 50 g available carbohydrate from the test food products.and the participants were instructed to ingest the breakfast with 10 min.
16130356|NCT01932073|Device|Low-Level Laser Therapy|Low-Level Laser Therapy will be applied, twice a week, from the moment skin reactions become painful until skin reactions are no longer painful
16130357|NCT01932060|Drug|Oxytocin Infusion|Patient will receive a blinded infusion of oxytocin after the time of delivery of the fetus which will terminate at the time of discharge from the post-anesthesia care unit.
16130358|NCT01932034|Device|BestDose Computer Software|BestDose is made by the USC Laboratory of Applied Pharmacokinetics. It uses a multiple-model, Bayesian adaptive control algorithm to find the maximally precise dose that will achieve a user-specified target concentration or concentrations.
16130359|NCT01932021|Procedure|adipose tissue grafting|
16130360|NCT01931995|Device|TMS positively correlated DLPFC|TMS, or transcranial magnetic stimulation, is a technique that is employed to non-invasively activate or suppress targeted regions of the cerebral cortex. One TMS system has been FDA approved to treat certain medically refractory forms of depression.
16130361|NCT01931995|Procedure|TMS to negatively correlated DLPFC|TMS, or transcranial magnetic stimulation, is a way of non-invasively activating or suppressing targeted regions of the cerebral cortex. One TMS system has been FDA approved to treat certain medically refractory forms of depression.
16130362|NCT01931982|Drug|Victoza|
16130363|NCT01931956|Device|MitraClip® implant|Percutaneous mitral valve repair using MitraClip implant
16130364|NCT01931943|Drug|selatinib ditosilate tablets|
16130365|NCT01931930|Dietary Supplement|Perilla extract|
16130366|NCT01931930|Dietary Supplement|Maltodextrin|
16130367|NCT01931917|Behavioral|Incredible Years Parents and Babies Program|4-5 home visits by health visitor IY parents and babies program 8 sessions Group of mothers Health visitor station Extra visits by health visitor if needed
16130368|NCT01931917|Behavioral|Usual Care|4-5 home visits by health visitor Group of mothers Health visitor station Extra visits by health visitor if needed
16130369|NCT01931878|Drug|incobotulinumtoxinA|The subject may be randomly assigned to receive incobotulinum toxinA (Xeomin) , a neurotoxin Which is approved for use by the FDA for certain conditions. This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is Xeomin, the second injections after a three month interval will be the inactive placebo. Double blind means neither the investigators nor the subject knows which one of the two (Xeomin or placebo) is received with the first or second injections.
16130370|NCT01931878|Drug|Placebo|The subject may be randomly assigned to receive Placebo which is an inactive test substance which has no active ingredient. In this protocol we use sterile salt water as placebo.This study has a double blind cross over design. Cross over means that you will have two sets of injections. If the first set of injections is placebo, the second injections after a three month interval will be active study drug. Double blind means neither the investigators nor the subject knows which one of the two (Xeomin or placebo) is received with the first or second injections.
16130371|NCT01931865|Drug|IncobotulinumtoxinA|Subject will receive Xeomin, injected into the area of reported focal pain associated with prior cancer treatment. The total dose will depend on the extent of the area involved by pain. botulinum toxin which is marketed under the trade name of Xeomin. Xeomin is approved by FDA for certain conditions.
16130372|NCT01931852|Procedure|Cardiac MRI|Participants in the CMR-guided care group will receive a cardiac MRI.
16130373|NCT01931852|Other|ACC/AHA Guideline adherent care|Participants in the invasive-based guideline-adherent care group will receive care adherent with current American College of Cardiology / American Heart Association (ACC/AHA) guideline recommendations. ( ACC/AHA Guideline adherent care )
16130374|NCT01931839|Drug|Lumacaftor Plus Ivacaftor Combination|Fixed dose combination tablet, oral use
16130375|NCT01931839|Drug|Ivacaftor|Film-coated tablet, oral use
16130376|NCT01931826|Procedure|Endoscopic treatment|The presence of gastroesophageal varices was confirmed by fiberoptic esophagogastroduodenoscopy (EGD). In view of the experience of our service and local circumstances at the time of the study, the endoscopic treatment of choice was sclerotherapy, performed with a Teflon-sheathed metal needle. The sclerosing agent was 2.5% monoethanolamine oleate. Esophageal varices visible on EGD in the pre- and post-treatment period were classified as small, medium or large on the basis of criteria proposed by Paquet. All complications attributable to sclerotherapy were recorded.
16130377|NCT01931826|Procedure|Total EGDS+ endoscopy|Esophagogastric devascularization with splenectomy followed by endoscopic sclerotherapy of esophageal varices 2 months postoperatively.
16130378|NCT01931800|Biological|Sampling of blood|
16130379|NCT01931787|Drug|6,8-bis(benzylthio)octanoic acid|Given IV
16130380|NCT01931761|Drug|[C14] selumetinib (oral)|Single oral administration [C14] 75mg
16130381|NCT01931748|Drug|MELSMON|
16130382|NCT01931748|Drug|UNCNT|
16130383|NCT01931735|Procedure|Randomized Meniscectomy|Arthroscopic meniscectomy
16130384|NCT01931735|Procedure|Randomized Lavage|Arthroscopic Lavage
16130385|NCT01931735|Procedure|Standard of Care Meniscectomy Pre-Amend|Arthroscopic meniscectomy
16130386|NCT01931735|Procedure|Standard of Care Meniscectomy Post-Amend|Arthroscopic meniscectomy
16130387|NCT01931722|Dietary Supplement|Branched chain amino acid|seven graded intakes of a BCAA (branched chain amino acid) mixture from 50 to 350 mg.kg-1.d-1 will be used to measure BCAA requirement
16130388|NCT01931722|Behavioral|Strength training|"Strength training will include a split-training program using all major muscle groups of the body on a three day on, one day off protocol. Muscle areas targeted on each training day will be as follows: Day1: chest, shoulder, triceps; Day2: back, biceps; Day3: legs and calfs; Day4: will be a rest day. On Day5: this cycle will begin again. A combination of free weights and machines will be used for each training day. Progressive overload protocol will be applied where the load used by every participant will be adjusted bi-weekly based on their 70% of 1 repetition maximum (maximum weight that can be lifted only one time). Instruction will be provided for all exercises and professional trainers will oversee all training sessions."
16130389|NCT01931709|Radiation|fludeoxyglucose F 18|Undergo FDG PET
16130390|NCT01931709|Device|positron emission tomography|Undergo FDG PET
16130391|NCT01931709|Device|dynamic contrast-enhanced magnetic resonance imaging|Undergo DCE-MRI
16130392|NCT01931709|Other|laboratory biomarker analysis|Correlative studies
16130393|NCT01931696|Device|Verum acupuncture|100 patients receive verum acupuncture treatment once every other day,choosing Dazhui(GV14), Fengmen(BL12), Feishu(BL13), needles retention for 30 minutes and no moxibustion or electrical stimulation. Patients receive verum acupuncture once every other day with a total of 20 sessions in 6 weeks. The needle brand is Hwato®™ Sterile Acupuncture Needles for Single Use.
16130394|NCT01931696|Device|Sham acupuncture|100 patients receive sham acupuncture treatment once every other day, choosing Jinsuo(DU08), Ganshu(BL18), Danshu(BL19), needles retention for 30 minutes and no moxibustion or electrical stimulation. Patients receive sham acupuncture once every other day with a total of 20 sessions in 6 weeks. The needle brand is Hwato®™ Sterile Acupuncture Needles for Single Use.
16130395|NCT01931683|Drug|remifentanil|The concentration of remifentanil was determined by modified Dixon's up-and-down method, starting from 1.0 ng/ml (0.2 ng/ml as a step size)
16130396|NCT01931683|Device|laryngeal mask airway (LMA)|LMA was removed when the patients opened their eyes, and spontaneous respiration and adequate tidal volume and ventilatory frequency were confirmed
16130397|NCT01931670|Other|placebo|
16130398|NCT01931670|Drug|Elagolix|
16130399|NCT01931657|Drug|Mifepristone prior to Mirena|
16130400|NCT01931657|Drug|Placebo prior to Mirena insertion|
16130401|NCT01931631|Behavioral|Low-fat, low-Glycemic Index, vegan diet|Low-fat, low-Glycemic Index, vegan diet
16130402|NCT01931631|Behavioral|ADA diet|Diet in accordance with the American Diabetes Association
16130403|NCT01931618|Behavioral|Online screening and feedback|An online single session screening procedure including individualized normative feedback.
16130404|NCT01931618|Behavioral|Online booklet.|An online booklet that covers general information about alcohol, its effect on the brain and the body, potential risks and harms of drinking, and an account of the threshold values of sensible drinking
16130405|NCT01931618|Behavioral|Online multi session follow-up|"An online multi session follow-up program (i.e., Balance). The central concept of Balance is to support continued self-regulation throughout the behavior change process. There are four key aspects of the program, the first is focus on goal setting and tracking of alcohol consumption on a day-to-day basis. The second on relapse prevention - for example, when clients report drinking more than their target, they receive individualized content aimed at preventing a full blown relapse. The third is emotion regulation, where content and assignments from positive psychology and from cognitive behavioral therapy are used. Finally, intervention covers alcohol education (i.e. the same topics as in the booklet provided to the control group)."
16130406|NCT01931605|Device|Prostatic arterial embolization using BeadBlock (Terumo)|Selective Prostatic arterial embolization using BeadBlock (Terumo)particuls
16130407|NCT01931592|Drug|ESBL eradication regimen|Fosfomycin-trometamol (3 g granules dissolved in 200 ml of water for oral administration every 72h) and colistin (2x106 IU oral solution dissolved in 50-100 ml of water given orally every 6 hours) and gentamicin (an 80 mg oral solution dissolved in 50-100 ml of water given orally every 6 hours) will be administered in a double-blind fashion for a total duration of 7 days (day 1-7). The placebo treatment will be identical in taste, consistency, colour and packaging. To include the oral cavity into the eradication regimen, all medications should be gargled for at least 10 seconds before being swallowed.
16130408|NCT01931592|Drug|Placebo ESBL eradication|Placebo preparations of fosfomycin, gentamicin and colisitin, identical in taste, texture and color will be administered at the same rate as the active comparator medication.
16130409|NCT01931579|Device|confocal endo-microscopy|The intervention consists of the use of confocal endo-microscopy using the CELLVIZIO device and either the 1 mm CELLVIZIO miniprobe (ALVEOFLEX) or the 0.6 mm CELLVIZIO miniprobe (CHOLANGIOFLEX), during a navigational bronchoscopy procedure for the diagnostic of peripheral nodule. In this study, the navigational device - either radial endobronchial ultrasound (EBUS) or electromagnetic navigation (EMN) - will be moved to another location if the CELLVIZIO displays a non solid pattern, indicating that the nodule may not have been reached during the procedure. Three attempts of EBUS or EMN are allowed until the CELLVIZIO shows a solid pattern.
16130410|NCT01931566|Drug|Pioglitazone|Pioglitazone SR tablets
16130411|NCT01931566|Drug|Pioglitazone placebo|Pioglitazone placebo-matching tablets
16130412|NCT01931553|Other|Standardized attending morning rounds|
16130413|NCT01931540|Behavioral|Exercise Training|Three times a week, for four months.
16130414|NCT01931527|Drug|Rasburicase|one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min
16130416|NCT01931514|Drug|Singulair® (Montelukast Sodium) Chewable Tablets 5mg|
16130417|NCT01931501|Drug|Torrent's Montelukast Sodium Chewable Tablets 5mg|
16130418|NCT01931501|Drug|Singulair® (Montelukast Sodium) Chewable Tablets 5mg|
16130419|NCT01931488|Other|MIBG label with I123 or I124|PD Patients who are not allergic to Iodine will be given 8 drops of Lugol . 30 min later, patients will be injected with 123I-MIBG 6 mci (222 MBq). 3 hours post-injection patients will undergo planar and SPECT imaging. at another day, patients will be injected with 124I-MIBG 0.8 mci (29.6 MBq). 3 hours post-injection patients will undergo PET-CT imaging.whole-body imaging. in the evaluation of neuroendocrine tumors-Patients who are not allergic to Iodine will be given 8 drops of Lugol.30 min later, patients will be injected with 123I-MIBG 6 mCi (222 MBq).3 hours and 24 hours post-injection patients will undergo planar and SPECT imaging. at another day, patients will be injected with 124I-MIBG 0.8 mCi (29.6 MBq). 3 hours and 24 hours post-injection patients will undergo PET-CT imaging.
16130420|NCT01931488|Device|SPECT imaging|
16130421|NCT01931475|Drug|Duloxetine|Administered orally
16130422|NCT01931475|Drug|Placebo|Administered orally
16130423|NCT01931462|Device|Microwave pre-coagulation|The Certus 140™ system is used for microwave pre-coagulation of the tissue around the part of the kidney to be removed. This is done in place of the standard clamping to stop blood loss.
16130424|NCT01931449|Procedure|Modified method of digestive tract reconstruction|
16130425|NCT01931449|Procedure|Routine digestive tract reconstruction|
16130426|NCT01931436|Drug|Qing'E pill|Qing'E pill is composed of eucommia, psoralen, walnuts and garlic.
16130427|NCT01931423|Behavioral|Placental cord drainage|
16130428|NCT01931410|Drug|Misoprostol|
16130429|NCT01931384|Drug|Human chorionic gonadotrophin|luteal phase support using Human chorionic gonadotrophin 1500 IU intramuscular injection will be given on the day of FET and 6 days later.
16130430|NCT01931384|Drug|Placebo|Normal saline intramuscularly on the day of embryo transfer and 5 days after embryo transfer.
16130431|NCT01931371|Procedure|Anal Fistula Plug|Surgical procedure for the treatment of anal fistula with an Anal Fistula Plug
16130432|NCT01931371|Procedure|Endorectal Advancement Flap|Surgical procedure for the treatment of anal fistula by an Advancement Mucosa Flap
16130433|NCT01931358|Biological|ALVAC-HIV|1 mL intramuscular injection containing 10^6 CCID50/dose
16130434|NCT01931358|Biological|AIDSVAX B/E|1 mL per injection (300 ug dose/antigen for a total of 600ug/dose administered)
16130435|NCT01931358|Biological|ALVAC-HIV Placebo|1 mL per injection
16130436|NCT01931358|Biological|AIDSVAX B/E Placebo|1 mL per injection
16130437|NCT01931345|Behavioral|Motivational Interviewing Counseling|Counseling developed by the research team based on a motivational interviewing approach
16130438|NCT01931345|Behavioral|Standard counseling|Counseling based on Quebec guidelines for rapid HIV testing
16130439|NCT01931332|Procedure|Femoral Nerve Block with levobupivicaine|A single injection femoral nerve block (FNB) performed in the supine position with a 50mm insulated needle (NanoLine, Pajunk, Geisingen, Germany) and peripheral nerve stimulator set at 1Hz with pulse width 0.1ms. Once a quadriceps muscle twitch is identified at a stimulated current between 0.2 and 0.5mA, 20mls of 0.375% levobupivacaine (75mg) is injected in fractionated amounts after negative aspiration
16130440|NCT01931332|Procedure|Intrathecal injection of diamorphine|500mcg of intrathecal diamorphine (ID) (dissolved in 0.5mls normal saline)
16130441|NCT01931319|Drug|Intravenous baclofen|
16130442|NCT01931306|Drug|Afatinib|BIBW2992 low to medium dose once daily
16130443|NCT01931293|Dietary Supplement|Supplementation of vitamin B complex, C, B12, folic acid, Iron and Zinic|Vitamin Supplement therapy
16130444|NCT01931280|Behavioral|Lifestyle Counseling|Participants receive lifestyle counseling on healthy eating and physical activity through an internet based program or self-directed educational program.
16130445|NCT01931267|Behavioral|Tablet Computer Motivated Instruction|Using tablet computer to motivate patient learning breath skill and maintain practive. Research nurse will give 3 times instruction to patients during hospitalization. This arm estimated including 77 subjects
16130446|NCT01931267|Behavioral|Systematic Instruction|Research nurse give 3 times systematic instruction during hospitalization This arm estimated including 77 subjects.
16130447|NCT01931241|Drug|AHRO-001|Cohort 1: 500 mg/dose, given as a single dose then as bid x7days and tid x 7days Cohort 2: 750 mg/dose, given as a single dose then as bid x7days and tid x 7days Cohort 3: 1000 mg/dose, given as a single dose then as bid x7days and tid x7days Cohort 4: 21 days dosing given at best tolerated dose determined by cohorts 1-3 Cohort 5: 12 wks dosing given at best tolerated dose determined by cohorts 1-4
16130448|NCT01931228|Procedure|MI-E plus manually assisted coughing|MI-E plus manually assisted coughing twice a day for 48h after extubation. After this period and before discharge of the icu or day28 maximum, patients received only one daily session.
16130449|NCT01931228|Procedure|manually assisted coughing|Manually assisted coughing twice a day for 48h after extubation. After this period and before discharge of the icu or day28 maximum, patients received only one daily session.
16130450|NCT01931215|Other|spinal anesthesia with intrathecal morphine|in addition to the standard spinal anesthesia drugs (bupivacaine and fentanyl), morphine is added
16130451|NCT01931215|Other|TAP-block with ropivacaine and clonidine|
16130452|NCT01931202|Drug|Escitalopram|Escitalopram is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class. It is FDA approved for the treatment of major depressive disorder (MDD) and generalized anxiety disorder (GAD) in adults and children over 12 years of age.
16130453|NCT01931202|Drug|Placebo oral tablet|Inert substance or treatment which is designed to have no therapeutic value but resemble the active medication in this study
16130454|NCT01931189|Biological|NI-071|100mg/vial
16130455|NCT01931189|Biological|Infliximab|100mg/vial
16130456|NCT01931176|Biological|rDEN2Δ30-7169 vaccine|Administered at a dose of 10^3 plaque-forming units (PFU); delivered by subcutaneous injection in the deltoid region of the upper arm
16130457|NCT01931176|Biological|Placebo|Delivered by subcutaneous injection in the deltoid region of the upper arm
16130458|NCT01931163|Drug|Everolimus|
16130459|NCT01931150|Drug|Topical Dapsone 5% Gel|
16130460|NCT01931150|Other|Moisturizer|The moisturizer for the study will be Vanicream™ Lite Lotion.
16130461|NCT01931150|Drug|oral antibiotics|
16130462|NCT01931137|Drug|insulin 338 (GIPET I)|Dose level of 8100 nmol will be orally administered as one tablet per dose.
16130463|NCT01931124|Behavioral|High Intensity Training|
16130464|NCT01931124|Behavioral|Moderate Intensity Training|
16130465|NCT01931098|Drug|topotecan|Taken .25 mg orally, daily continuous until progression up to one year.
16130466|NCT01931098|Drug|pazopanib|600 mg orally, daily until progression, up to one year.
16130467|NCT01931085|Drug|Triclabendazole|Triclabendazole (10 mg/kg body-weight as a single dose).
16130468|NCT01931072|Behavioral|High-intensity interval training|Interval training 3 times a week for 8 weeks
16130469|NCT01931072|Behavioral|Moderate training|Moderate training 3 times a week for 8 weeks
16130470|NCT01931059|Drug|Risperidone|We gave oral liquid of risperidone one time 1-2 mg depending on subject's weight.
16130471|NCT01931059|Other|Placebo|We gave oral liquid without active risperidone (pt and provider were both double blinded)
16130472|NCT01931046|Drug|Ad5-SGE-REIC/Dkk3|Ad5-SGE-REIC/Dkk-3, was designed to increase intracellular production REIC protein. The adenovirus vector is a transport mechanism to infuse the REIC protein into the cell providing a temporary transfusion of protein that induces apoptosis in target cancer cells, but does not appear to have a significant effect on normal tissues.
16130473|NCT01931033|Drug|Intranasal Oxytocin|
16130474|NCT01931020|Drug|Sucrose|The enrolled neonates will be administered 1ml of 24% sucrose. After 2 minutes heel lancing will be performed after cleaning the heel of neonate with a sterile spirit swab, with an auto lancet. Neonate's faces and monitor screen will be filmed in real time by using two independent video cameras during the entire procedure i.e. staring 2 minutes prior to heel lance and continue 2 minutes after the procedure. The PIPP will be assessed at 30 seconds, 1 minute and 2 minute after the procedure.
16130475|NCT01931020|Drug|Glucose|The enrolled neonates will be administered 1ml of 25% gluose. After 2 minutes heel lancing will be performed after cleaning the heel of neonate with a sterile spirit swab, with an auto lancet. Neonate's faces and monitor screen will be filmed in real time by using two independent video cameras during the entire procedure i.e. staring 2 minutes prior to heel lance and continue 2 minutes after the procedure. The PIPP will be assessed at 30 seconds, 1 minute and 2 minute after the procedure.
16130476|NCT01931007|Drug|Autologous Bone Marrow Aspirate Concentrate|Autologous Bone marrow aspirate will be concentrated using Magellan Cell Separator and stem cell kit according to the Standard Operating Procedures is to be injected in the treatment knee. 5ml of treatment cells will be combined with 10 ml of previously separated platelet poor bone marrow plasma and used for injection under ultrasound guidance into one of the subject's painful knees.
16130477|NCT01931007|Drug|Sterile saline|Bacteriostatic 0.9% sodium chloride, preservative free manufactured by Hospira will be injected into the control knee.
16130478|NCT01930955|Drug|Amoxicillin|β-lactam antibiotics
16130479|NCT01930942|Radiation|preoperative concurrent chemoradiation|Radiation is given with 5000 cGy in 25 fractions (5 weeks). Concurrent chemotherapy consists of oxaliplatin (50 mg/m2 ) intravenously over 2 h on days 1, 8, 15, 22 and 29, and capecitabine (825 mg/m2 twice day) was given orally on each day of radiation.
16130480|NCT01930929|Procedure|Bariatric surgery|
16130481|NCT01930916|Device|INR capillary measurement with INRatio 2 device|INR capillary measurement with INRatio 2 device
16130482|NCT01930916|Other|antiphospholipid antibodies and lupus anticoagulant|Rate of antiphospholipid antibodies and lupus anticoagulant dosage A 5ml blood sample obtained by veinous punction.
16130483|NCT01930903|Device|Pantera Lux Drug Eluting Balloon|All patients are treated with the PRO-Kinetic Energy Stent and Pantera Lux drug eluting balloon for the last post dilatation.
16130484|NCT01930890|Biological|BIIB023|
16130485|NCT01930890|Drug|mycophenolate mofetil|titrated to a target daily dose of 2 g (1 g twice daily)
16130486|NCT01930890|Drug|oral corticosteroids|oral corticosteroids (prednisone or equivalent) at a target prednisone dose of 10 mg/day
16130487|NCT01930877|Drug|Lidocaine|Lidocaine iv bolus followed by infusion
16130488|NCT01930877|Other|Placebo (normal saline)|Normal saline bolus followed by infusion
16130489|NCT01930864|Drug|metformin|metformin up to 2500mg/d
16130490|NCT01930864|Drug|irinotecan|Irinotecan 350 mg/m² IV q21d
16130491|NCT01930851|Procedure|Gastric bypass operation|
16130492|NCT01930838|Procedure|Gastric bypass operation|
16130493|NCT01930812|Procedure|NaF PET/CT Imaging|Diagnostic imaging test that is considered investigational
16130494|NCT01930812|Procedure|99mTc-medronate whole body bone scan with SPECT|99mTc-medronate whole body bone scan with SPECT imaging. Note, that this is a standard procedure in this patient population and thus is not considered investigational.
16130495|NCT01930812|Drug|18F-Sodium Fluoride (NaF)|A single radioactive dose of 18F-NaF (185-370 MBq) is intravenously administered to subject 60 minutes prior to PET/CT imaging to evaluate whether or not subject has bone metastasis from advanced prostate or breast cancer. Entire procedure from injection to scan completion will take about 2.25 hours
16130496|NCT01930799|Behavioral|Systematic Screening and Education Regimen|Site will implement a systematic approach to screening bladder health dysfunction in multiple sclerosis patients, providing bladder health management education, and initiating appropriate urologist referrals.
16130497|NCT01930786|Drug|onabotulinumtoxinA|onabotulinumtoxinA administered according to physician standard of care. All treatment decisions lie with the physician.
16130498|NCT01930773|Device|Genotyping|Patients harboring CYP2C19 *2 alleles receive 60 mg prasugrel for PCI, while non-carriers receive 600 mg clopidogrel if not pretreated with clopidogrel.
16130499|NCT01930773|Device|Phenotyping|Patients having high on-treatment platelet reactivity (HPR: greater than 208 PRU) receive 60 mg prasugrel loading dose (LD), others continue clopidogrel for PCI.
16130531|NCT01930539|Device|Ultraviolet B lamp|Ultraviolet-Fluorescent lamp (KBD, Inc, Crescent Springs, Kentucky, USA) was designed to use Ultraviolet B emitting fluorescent bulbs that have lower heat emission and allows a larger area of skin exposure. The Lamp is equipped with a timer for improved safety. This device is FDA (Food and Drug Administration) approved.
16130532|NCT01930526|Other|Pulmonary Rehabilitation|Pulmonary Rehabilitation (PR) is a short course 6-12 weeks of supervised exercise training and education for patients with COPD. This is part of their usual treatment. This study is replacing two-legged cycling with single leg training. Patients will have the usual PR outcome measures assessed but in addition will have a laboratory exercise test.
16130500|NCT01930760|Behavioral|Standard Medical Training Educational|"Educational is modeled on the Theory of Planned Action, which proposes that unless people believe that their actions can have an effect on the desired outcome they have little incentive to act or persevere in the face of difficulties. Based on this theory we will be providing physicians with information on how to calculate, plot and track BMI and how this can be associated with identification of overweight children before they present with symptoms of obesity. This intervention will attempt to demonstrate that BMI calculating, plotting and tracking are useful diagnostic monitoring tools and that their actions may lead to more effective prevention and/or treatment.
~The education intervention will not prescribe specific discussion initiation tools, although the participants will not be prevented from independently changing their communication behaviour."
16130501|NCT01930760|Behavioral|Motivational Interviewing behavioural|The behavioural intervention will incorporate specific Motivational Interviewing (MI) tools and information from a previously completed qualitative study with obese children (Obadia et al.). This study generated suggestions of how physicians can encourage children to think positively about making changes towards a healthier body weight. This intervention is designed to address physicians' lack of self-efficacy in communicating with children and their families about achieving a healthy body weight, and therefore would likely benefit from the input from children and the patient-centred theme of MI. It is based on the Trans-Theoretical Model and Stages of Change which postulates that people follow a step-wise progression towards change with specific constructs that need to be addressed before moving to the next step. These constructs are integral to the principles of MI
16130502|NCT01930747|Drug|rocuronium|measure effect on laparoscopic workspace
16130503|NCT01930747|Drug|Sevoflurane|1 MAC sevoflurane inhalation is given
16130504|NCT01930747|Drug|remifentanyl|remifentanyl is given in infusion
16130505|NCT01930734|Drug|Dobutamine|Dobutamine infusion up to 5mcg/Kg/min
16130506|NCT01930734|Drug|Normal Saline|Normal Saline solution 0.9% Placebo Arm
16130507|NCT01930721|Procedure|episiotomy|incision angle of episiotomy will be 60 degrees.
16130508|NCT01930721|Procedure|episiotomy|incision angle of episiotomy will be 40 degree before cutting.
16130509|NCT01930708|Drug|dimethyl fumarate|Administered as per the approved dosage in all countries where DMF has received marketing authorization.
16130510|NCT01930682|Drug|Alteplase|Alteplase is given as a intravenous bolus (8-mg) followed by 42 mg iv gtt in 90 min.
16130511|NCT01930682|Procedure|Early post-fibrinolytic catheterisation|Early post-fibrinolytic catheterisation after 3 hours but within 24 hours of the start of fibrinolytic therapy is performed, if required, PCI or, in case of insufficient ST resolution at 90 min,rescue PCI. The decision on rescue PCI will, however, be taken 90 min (or earlier if clinically indicated) after injection of alteplase according to the ST resolution (less than 50% reduction in ST-segment elevation).
16130512|NCT01930682|Procedure|Primary PCI|For STEMI Patients,primary PCI is performed within 12 hours after the onset.
16130513|NCT01930669|Other|Gravitational sympathetic stimulus|"Autonomic nervous system (ANS) activity is assessed by means of HRV, SAP variability and baroreflex control analysis daily from day 1 to discharge from ICU or day 28.
~Analysis is performed (i)at rest in supine position with bed at zero degrees of inclination (ii) during modified tilt (MTILT) and (iii) recovery from MTILT in supine position at zero degrees. In a subgroup of patients motor sympathetic nervous activity (MSNA) is recorded at day 1,2 and 7.
~MTILT consists in elevating head and trunk of patients at 60 degrees and lowering legs at 15 degree with a standard critical care bed. MSNA is recorded from the external peroneal nerve with microneurographic technique."
16130514|NCT01930643|Device|EMS|HELEX 573 : strength aggravation mode with middle frequency carrier(1500Hz), minimal voltage for visible muscle contraction(maximum output is 75mA) , 32 minutes per day.
16130515|NCT01930630|Device|Extraesophageal saline injection (ESI)|The patients with advanced ESCC are to undergo extraesophageal injection of 15ml saline preoperatively and subsequently detected by EUS to confirm whether saline separates esophagus from adjacent organs.
16130516|NCT01930617|Procedure|Burr hole surgery with various drainage techniques|"Surgical technique
~Continuous irrigation and drainage
~Passive subdural drain
~Active subgaleal drain"
16130517|NCT01930604|Drug|Botox (onabotulinumtoxinA)|
16130518|NCT01930604|Drug|NeuroBloc/Myobloc (rimabotulinumtoxinB)|
16130519|NCT01930604|Drug|NaCl (placebo)|
16130520|NCT01930591|Drug|Ticagrelor|180 mg bolus followed by 90 mg BID
16130521|NCT01930591|Drug|Clopidogrel|300 mg bolus followed by 75 mg OD
16130522|NCT01930578|Other|Treatment with 0.9% normal saline|"An oral dose of 0.33ml/kg of 10% Sodium Bromide solution at each of 3 study visits. Each dose of Sodium Bromide will be mixed with an equivalent volume; 1:1 of sterile water before oral intake.
~An IV infusion of (1) 0.9% saline, (2) 5% Dextrose or (3) 3.3% Dextrose and 0.3% saline will be given at a rate of 1 liter over an hour in a randomized crossover design."
16130523|NCT01930578|Other|Treatment with D5+ 0.45 saline|"An oral dose of 0.33ml/kg of 10% Sodium Bromide solution at each of 3 study visits. Each dose of Sodium Bromide will be mixed with an equivalent volume; 1:1 of sterile water before oral intake.
~An IV infusion of (1) 0.9% saline, (2) 5% Dextrose or (3) 3.3% Dextrose and 0.3% saline will be given at a rate of 1 liter over an hour in a randomized crossover design."
16130524|NCT01930578|Other|Treatment with D5|"An oral dose of 0.33ml/kg of 10% Sodium Bromide solution at each of 3 study visits. Each dose of Sodium Bromide will be mixed with an equivalent volume; 1:1 of sterile water before oral intake.
~An IV infusion of (1) 0.9% saline, (2) 5% Dextrose or (3) 3.3% Dextrose and 0.3% saline will be given at a rate of 1 liter over an hour in a randomized crossover design."
16130525|NCT01930565|Other|LFCO application|Application of LFCO (Lactobacillus fermented Chamaecypris obtusa ) containing creams to one randomly selected face of patients to monitor its effectiveness and safety of acne treatments.
16130526|NCT01930565|Other|TTO application|Application of TTO (Tea tree oil) containing creams to the other side of face of patients to monitor its effectiveness and safe compared with LFCO.
16130527|NCT01930552|Drug|Aflibercept AVE0005|Pharmaceutical form:Solution for infusion Route of administration: Intravenous
16130528|NCT01930552|Drug|Leucovorin|Pharmaceutical form:Solution for infusion Route of administration: Intravenous
16130529|NCT01930552|Drug|Irinotecan|Pharmaceutical form:Solution for infusion Route of administration: Intravenous
16130530|NCT01930552|Drug|5-Fluorouracil|Pharmaceutical form:Solution for infusion Route of administration: Intravenous
16130753|NCT01928901|Drug|administration of Sinupret Placebo|
16130533|NCT01930500|Behavioral|Individual neuropsychological rehabilitation|Psychoeducation, teaching compensatory strategies and offering psychological support to better cope with dyslexia
16130534|NCT01930500|Behavioral|Group based neuropsychological rehabilitation|Psychoeducation, teaching compensatory strategies and offering psychological support and peer support to better cope with dyslexia
16130535|NCT01930487|Dietary Supplement|dietary supplement with antioxidants|Formulation contains vitamins, a mineral, dietary antioxidants, amino acids, polyphenols and polyunsaturated fatty acids
16130536|NCT01930487|Dietary Supplement|Placebo|Placebo - Softgels manufactured to mimic the appearance of active, dietary supplement with antioxidants
16130537|NCT01930461|Biological|SLIT tablets of HDM allergen extracts, 3 different doses (A)|Two sublingual tablets daily for 13 months
16130538|NCT01930461|Biological|SLIT tablets of HDM allergen extracts, 3 different doses (B)|Two sublingual tablets daily for 13 months
16130539|NCT01930461|Biological|SLIT tablets of HDM allergen extracts, 3 different doses (C)|Two sublingual tablets daily for 13 months
16130540|NCT01930461|Biological|Placebo matching the SLIT tablets of HDM allergen extracts|Two sublingual tablets daily for 13 months
16130541|NCT01930435|Device|Sterile Humidification Device|This is a personal humidification device. It is hand held and produces sterile warm vapor.
16130542|NCT01930422|Device|tDCS procedure|The tDCS is a non-invasive neuromodulation method. A stimulator delivers a constant current of low intensity (1-2 mA) applied to the average of two bipolar electrodes placed on the scalp for 20 minutes. This constant current generates a static electric field that selectively modulates the activity of cortical neurones. A tingling sensation under the electrodes appears at the beginning and at the end of stimulation but it is transient and disappears quickly in 30 or 60 seconds.
16130543|NCT01930422|Device|Sham procedure|The tDCS placebo differs from the real tDCS by the interruption of stimulation after 30 to 60 seconds and reactivation of this stimulation 30 to 60 seconds before the end of the session, which lasted 20 minutes. The tingling felt at the beginning and the end of the session will be the same as those experienced with real stimulation. The electrodes establishment does not differ with respect to tDCS.
16130544|NCT01930409|Behavioral|Telephone Support and Coaching|"The participants will receive up to 5 telephone calls of 30-45 minutes each after hospital discharge to provide support and education for the transition from acute to community care. The first call will be made within 48-72 hours of hospital discharge and will have the following elements:
~Health Status
~Medication Management
~Activity/Exercise Prescription and Goal-Setting
~Falls Prevention
~Clarification of Appointments
~Coordination of Post-Discharge Home Services
~What To Do If a Problem Arises"
16130545|NCT01930409|Behavioral|Education Only|An educational toolkit will be provided, with materials to self manage at home after hospital discharge following a fall related hip fracture
16130546|NCT01930396|Drug|Tinzaparin|
16130547|NCT01930396|Drug|Unfractionated Heparin|
16130548|NCT01930396|Drug|Placebo (for Tinzaparin)|0.9% Normal Saline
16130549|NCT01930396|Drug|Placebo (for Unfractionated Heparin)|0.9% Normal Saline
16130550|NCT01930370|Drug|Bicarbonate hemodialysis solution (low concentration)|One-week experimental session (3 dialysis treatments) with low dialysate bicarbonate (28 mmol/L)
16130551|NCT01930370|Drug|Bicarbonate hemodialysis solution (high concentration)|One-week experimental session with high dialysate bicarbonate (38 mmol/L)
16130552|NCT01930357|Biological|Purified Vero Rabies Vaccine Serum Free (VRVg)|0.5 mL, Intramuscular (Day 0, Day 7 and Day 28).
16130553|NCT01930357|Biological|Imovax® Rabies: Human Diploid Cell Vaccine (HDCV),|0.5 mL, Intramuscular (Day 0, Day 7 and Day 28).
16130554|NCT01930344|Device|3D Laparoscopic visual system|Three-dimensional endoscope used for surgery - multiple company products - and passive polarising three-dimensional laparoscopic displays;
16130555|NCT01930344|Device|2D Laparoscopic visual system|Standard 2D HD Laparoscopic Visual System
16130556|NCT01930331|Drug|artemisinin/naphthoquine|"Each tablet of ARCO (artemisinin/naphthoquine) contains 125 mg artemisinin and 50 mg of naphthoquine. The total dose for adults will be 1000mg of artemisinin and 400mg of naphthoquine in a fixed oral dose (ARCO tablet).
~The regimen for children will be calculated according to the body weight (20mg artemisinin + 8mg naphthoquine per kg body weight in a fixed oral dose(ARCO tablet))."
16130557|NCT01930331|Drug|dihydroartemisinin/piperaquine phosphate|Eurartesim (dihydroartemisinin/piperaquine phosphate) is a fixed dose preparation with two dose-strengths (20 mg dihydroartemisinin and 160mg of piperaquine phosphate and 40mg dihydroartemisinin and 320mg of piperaquine phosphate. The regimen for patients with body weight of 36-75kg is three tablets of 40mg dihydroartemisinin and 320mg of piperaquine phosphate once daily for three consecutive days. Those beyond or below this range the regimen will be calculated based on the body weight.
16130558|NCT01930318|Drug|parecoxib|4 groups: PCA,Placebo,Placebo-PCA for 2 days after operation, i.v placebo in 2 days after surgery and oral placebo in the day 3 to day 5 after surgery; PCA,placebo,tramadol-PCA for 2 days after operation, i.v placebo in 2 days after surgery, and oral tramadol(0.1g t.i.d.) in the day 3 to day 5 after surgery;PCA,parecoxib,placebo-PCA for 2 days after operation, i.v parecoxib(40mg b.i.d.) in 2 days after surgery,and oral placebo in the day 3 to day 5 after surgery;PCA,parecoxib,celecoxib-PCA for 2 days after operation,i.v parecoxib(40mg b.i.d.) in 2 days after surgery and oral celecoxib(0.2g b.i.d.) in the day 3 to day 5 after surgery
16130559|NCT01930292|Drug|Part A: Debio 1143|Adaptive doses of Debio1143 oral capsules, between 50 and 400 mg until the recommended dose (RD) is determined.
16130560|NCT01930292|Drug|Paclitaxel|Paclitaxel standard of care, intravenous (IV), once on day 1 or 2 of each 21-day treatment cycle, after pre-medication to prevent severe hypersensitivity reactions.
16130561|NCT01930292|Drug|Carboplatin|Carboplatin standard of care, intravenous (IV), once on day 1 or 2 of each 21-day treatment cycle.
16130562|NCT01930292|Drug|Part B: Debio 1143|RD of Debio1143 oral capsules, once daily for five consecutive days starting on day 1 or 2 of each 21-day treatment cycle.
16130563|NCT01930279|Other|Blood withdrawal|Blood withdrawal
16130564|NCT01930266|Dietary Supplement|Experimental|
16130565|NCT01930266|Behavioral|Active comparator|
16130566|NCT01930240|Drug|TRIA-662|1-MNA Chloride
16130567|NCT01930240|Drug|Placebo|Double-blind placebo
16130568|NCT01930227|Other|TEAS|Electric stimulation was given through electrode attached to specific acupoints
16130569|NCT01930227|Other|Non-acupoint stimulation|Electric stimulation was given through electrode attached to the shoulder
16130570|NCT01930214|Device|Percutaneous Coronary Intervention|Any Food and Drug Administration (FDA) commercially available device for treating none/mild, moderate, and severe calcified coronary lesions, with the exception of CSI's Coronary Orbital Atherectomy System (OAS).
16130571|NCT01930201|Procedure|Caudal epidural block|
16130572|NCT01930201|Other|General anesthesia|
16130573|NCT01930188|Drug|semaglutide|For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication.
16130574|NCT01930188|Drug|sitagliptin|Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication.
16130575|NCT01930188|Drug|placebo|Tablets for oral administration once daily. The trial drug will be added on to the subject's stable pre-trial medication.
16130576|NCT01930188|Drug|placebo|For subcutaneous injection (s.c., under the skin) once weekly. Will follow a fixed dose escalation regimen. The trial drug will be added on to the subject's stable pre-trial medication.
16130577|NCT01930175|Drug|VAY736|
16130578|NCT01930175|Drug|Placebo|
16130579|NCT01930162|Drug|HSC835|HSC835 is a stem cell therapy product providing a source of Hematopoietic stem cell (HSC).
16130580|NCT01930149|Behavioral|Mailed patient outreach intervention|This study's intervention is a mailed outreach letter from the health center that encourages cholesterol testing and describes the steps necessary to obtain the test at the patient's care site. Clinic staff will facilitate the ordering of tests for patients who may not have an office visit.
16130581|NCT01930136|Behavioral|Calorie restriction (25%)|
16130582|NCT01930136|Behavioral|Ad libitum health diet|
16130583|NCT01930123|Drug|intravenous fructose challenge|"Patients will be admitted to our Duke Clinical Research Unit (DCRU) at least 12 hours prior to morning intravenous fructose challenge. All patients will have a standard meal in order to control for dietary composition and calorie intake prior to intravenous fructose challenge. Patients will be NPO after midnight for morning IV fructose MR biomarker measures. Patients with suspected NAFLD will have a standard of care , liver biopsy followed by , and co-localization of liver biopsy with MR."
16130584|NCT01930110|Other|60-minute exercise|Patients will be admitted at the research clinical facility at 14:30. Closed-loop strategy will start at 15:30. At 18:00, patients will performed a 60-minute exercise at 60% of VO2 max. Patients will be discharged at 20:00.
16130585|NCT01930110|Other|40-minute interval exercise|Patients will be admitted at the research clinical facility at 14:30. Closed-loop strategy will start at 15:30. At 18:00, patients will performed a 40-minute interval exercise. Patients will be discharged at 20:00.
16130586|NCT01930097|Other|14 hours intervention|Subjects will be admitted at the IRCM at 6:30. Subjects will be asked to fast from midnight. At 8:00, a standardized (50g CHO for males; 30g CHO for females) meal will be served. At 12:00, a standardized (120g CHO for males; 90g CHO for females) meal will be served. At 17:00, a standardized (70g CHO for males; 50g CHO for females) meal will be served. Between meals, patients will be allowed to do sedentary activities (reading, watching television, and playing video games, etc).
16130587|NCT01930084|Other|Point of care CD4+ after HIV diagnosis|Point of care (POC) CD4+ testing immediately following HIV diagnosis
16130588|NCT01930084|Other|Accelerated ART initiation|Accelerated ART initiation for eligible participants delivered by facility personnel
16130589|NCT01930084|Behavioral|SMS appointment reminders|Cellular appointment reminders delivered by study personnel
16130590|NCT01930084|Other|Non-cash Financial Incentives|Non-cash Financial Incentives
16130591|NCT01930071|Device|PQ Bypass Guide Wire Delivery System|The PQ Bypass Guide Wire Delivery System is used to bypass lesions in the peripheral vasculature percutaneously. A guidewire is placed from the artery proximal to the lesion to the artery distal to the lesion using the vein as a conduit with the Guidewire Delivery System. Once in place, commercially available stent grafts will be placed to complete the bypass.
16130592|NCT01930058|Drug|MK-8876|MK-8876 10 mg or 100 mg tablets taken q.d. by mouth.
16130593|NCT01930045|Drug|Raltegravir (ISENTRESS™)|Raltegravir 400 mg oral tablet once every 12 hours. Participants will continue with their other prescribed antiretroviral agents throughout the study.
16130594|NCT01930045|Drug|MAALOX (MAL)|MAL (or generic equivalent) 20 mL oral single dose on Day 1
16130595|NCT01930019|Drug|Intravenous administration of the induction agent of general anesthesia (etomidate or thiopental)|
16130596|NCT01930006|Drug|MGCD265|
16130597|NCT01929993|Procedure|SWETZ|Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix.
16130598|NCT01929993|Procedure|LLETZ cone|LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. The loop is applied to the cervix outside the lateral margin of the transformation zone and brought slowly to the controlateral transformation zone margin.
16130599|NCT01929980|Drug|Bortezomib|
16130600|NCT01929954|Biological|Gintuit|One time placement of Gintuit over socket graft.
16130601|NCT01929954|Device|Bio-Gide|One time placement of Bio-Gide over socket graft.
16130602|NCT01929941|Drug|INCB047986|Initial cohort dose of INCB047986 monotherapy at the protocol-specified starting dose, with subsequent cohort escalations based on protocol-specific criteria
16130603|NCT01929941|Drug|INCB047986|INCB047986 tablets administered orally at the protocol specified dose and frequency
16130604|NCT01929941|Drug|Gemcitabine|Gemcitabine administered intravenously over 30 minutes at the protocol-specified dose and frequency
16130605|NCT01929941|Drug|nab-paclitaxel|nab-paclitaxel administered intravenously over 30 minutes at the protocol-specified dose and frequency
16130606|NCT01929915|Procedure|Epidural patient controlled analgesia|Patient controlled epidural analgesia with marcaine(1mg/ml)+ fentanyl(1.25mcg/ml)for postoperative pain control
16130607|NCT01929915|Drug|Intravenous patient controlled analgesia|Intravenous patient controlled analgesia with morphine(1mg/ml)for post operative pain control
16130653|NCT01929551|Other|Fresh natural mango|Capillary glucose will be taken every 15 minutes for two hours (starting at time 0) to calculate the area under the curve which is the glycemic index, for each of the products.
16130654|NCT01929551|Other|Frozen natural mango|Capillary glucose will be taken every 15 minutes for two hours (starting at time 0) to calculate the area under the curve which is the glycemic index, for each of the products.
16130608|NCT01929889|Drug|Iloperidone|Patients in this study will be treated with Fanapt® (iloperidone). They will begin a standardized up-titration starting with a dose of 2 mg daily. Dose increases will continue until the subject has achieved clinical stability, has achieved the maximum dose of 24 mg/day, or until 8 weeks have elapsed. Once clinical stability has been achieved, the patient will continue into the treatment phase. If clinical stability is not achieved after 8 weeks, the patient will be excluded from the study.
16130609|NCT01929876|Drug|Cobimetinib|10 milligram (mg) (2* 5 mg capsules) will be administered orally on Day 1 of Period 1 and Day 4 of Period 2
16130610|NCT01929876|Drug|Itraconazole|200 mg oral solution will be administered once daily from Day 1 to Day 14 of Period 2
16130611|NCT01929863|Drug|GSK2330672|GSK2330672 will be supplied as oral solution, and will be administered BID [45 mg (2 days repeat dose) and 90 mg (5 days repeat dose) in each period]
16130612|NCT01929863|Drug|Placebo|GSK2330672 matching placebo will be supplied as oral solution, and will be administered BID (7 days of dosing in each period)
16130613|NCT01929863|Drug|Metformin|Metformin 850 mg will be administered BID from Run-in period till Day 7 of period 2
16130614|NCT01929850|Procedure|Laparscopic Sleeve Gastrectomy|The laparoscopic sleeve gastrectomy involves the placement of 5 trocars. A leak check may be performed at the same time by insufflating with a gastroscope with the remnant gastric section submerged in irrigation fluid and by infusing sterile methylene blue through a nasogastric tube. The staple line may be oversewn (3-0 Vicryl, Ethicon), only along the bleeding and leakage areas, or areas with the potential for such complications. A nasogastric decompression tube placed to monitor bleeding and an intraperitoneal drain was placed under an anastomotic stoma.
16130615|NCT01929850|Behavioral|Weight Watchers Program|Intensive medically supervised nutritional and exercise therapy
16130616|NCT01929837|Device|E-fied navigated rTMS|1 hz on the superior temporal gyrus contralateral/left side with E-field navigated rTMS (Nexstim) targeted at the tonotopic representation area of the main frequency content of tinnitus
16130617|NCT01929837|Device|non-navigated rTMS|1 hz on the superior temporal gyrus contralateral/left side with non-navigated rTMS according to external landmarks (between T3/T4 and P3/P4 EEG-electrode locations)
16130618|NCT01929837|Device|sham E-field navigated rTMS|
16130619|NCT01929837|Device|Navigated rTMS|1 hz on the left superior temporal gyrus with (MRI) navigated rTMS (Visor)
16130620|NCT01929824|Other|Oral Nitric Oxide testing|o Oral nitric oxide is measured by a breathing test where the participant will be seated in a chair and asked to breathe out into a small hand-held instrument for about 6 seconds.
16130621|NCT01929811|Drug|Metformin|Metformin: 500mg tid, orally (500mg daily in first cycle) on day 1 to day 21 of each 21 day cycle
16130622|NCT01929811|Drug|Docetaxel|75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle; 6 cycles.
16130623|NCT01929811|Drug|Epirubicin|75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle; 6 cycles.
16130624|NCT01929811|Drug|cyclophosphomide|500 mg/m2, IV (in the vein) on day 1 of each 21 day cycle; 6 cycles.
16130625|NCT01929798|Device|portable Artificial Pancreas|The artificial pancreas system will be allowed to employ its Model Predictive Control algorithm to make decisions about insulin delivery based on measured glucose levels.
16130626|NCT01929759|Drug|Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)|Switch from Atripla (efavirenz, emtricitabine and tenofovir) to Stribild (elvitegravir, cobicistat, emtricitabine and tenofovir)for total of 8 weeks
16130627|NCT01929746|Biological|BIIB019 subcutaneous injection|participants will be randomized to receive a single subcutaneous injection of BIIB019, 75 mg or 150 mg per dose group
16130628|NCT01929720|Behavioral|Cognitive-behavioral therapy for worry, uncertainty & insomnia|This intervention involves teaching the participant in-person strategies for managing worry, uncertainty, and insomnia and involves home practice.
16130629|NCT01929707|Drug|LY3050258|
16130630|NCT01929707|Drug|Placebo|
16130631|NCT01929694|Dietary Supplement|Berocca Boost|
16130632|NCT01929694|Dietary Supplement|Placebo|
16130633|NCT01929681|Device|Low Field Magnetic Stimulation|Low Field Magnetic Stimulation is an electromagnetic technique. It uses low strength electric fields operating at a high frequency.
16130634|NCT01929668|Drug|polyethylene glycol|
16130635|NCT01929668|Drug|Ascorbic Acid|
16130636|NCT01929655|Drug|Radium-223 dichloride (Xofigo, BAY88-8223)|BAY88-8223, 50 kBq/kg will be administered as slow bolus intravenous injection 6 times at intervals of 4 weeks between each administration
16130637|NCT01929642|Drug|Sirolimus|
16130638|NCT01929642|Drug|Everolimus|
16130639|NCT01929629|Drug|Part A|Single ascending doses
16130640|NCT01929629|Drug|Part B|Single doses food effect. Subjects to receive 2 single doses, one in fed and one in fasted.
16130641|NCT01929616|Drug|regorafenib|Patients will receive 160 mg regorafenib 1/day 3 weeks out of 4.
16130642|NCT01929603|Procedure|Pharmacokinetic sampling|Blood sampling to measure olaparib, rifampicin and 4β-hydroxycholesterol
16130643|NCT01929603|Drug|Rifampicin|Rifampicin (CYP inducer) 600mg taken once daily from Day 5 to Day 14 (Part A)
16130644|NCT01929603|Drug|Olaparib tablet dosing|Olaparib 300mg tablet taken on Days 1 and 14 (Part A). Part B dosing is 300mg olaparib bi-daily
16130645|NCT01929590|Drug|PEG-3350 group 2|split-dose (PEG-3350; 2 L the day before 17:00-19:00 h and 2 L same day of the procedure 06:00-08:00 am)
16130646|NCT01929590|Drug|PEG-3350 group 1|PEG-3350; PEG-4 L the day previous of the study, starting at 17:00 and finishing at 21:00 h
16130647|NCT01929590|Drug|PEG-3350 group 3|low-volume 2 L PEG-solution (same day of the procedure 06:00-08:00 am)
16130648|NCT01929577|Drug|ASP015K|oral tablet
16130649|NCT01929564|Other|Beneforte broccoli|Four x 100g portions of Beneforte broccoli will be consumed each week for twelve weeks, on top of the participants habitual diet
16130650|NCT01929564|Other|Parthenon Broccoli|Four x 100g portions of Parthenon broccoli will be consumed each week for twelve weeks, on top of the participants habitual diet
16130651|NCT01929551|Other|Mango puree and pear juice beverage|Capillary glucose will be taken every 15 minutes for two hours (starting at time 0) to calculate the area under the curve which is the glycemic index, for each of the products.
16130652|NCT01929551|Other|Commercial mango juice|Capillary glucose will be taken every 15 minutes for two hours (starting at time 0) to calculate the area under the curve which is the glycemic index, for each of the products.
16130655|NCT01929551|Other|Processed natural mango pulp|Capillary glucose will be taken every 15 minutes for two hours (starting at time 0) to calculate the area under the curve which is the glycemic index, for each of the products.
16130656|NCT01929551|Other|Mix of natural mango and pear|Capillary glucose will be taken every 15 minutes for two hours (starting at time 0) to calculate the area under the curve which is the glycemic index, for each of the products.
16130657|NCT01929551|Other|50 grams glucose load|Capillary glucose will be taken every 15 minutes for two hours (starting at time 0) to calculate the area under the curve which is the glycemic index, for each of the products.
16130658|NCT01929538|Procedure|ERCP|endoscopic retrograde cholangiopancreatography
16130659|NCT01929538|Device|covered self-expanding biliary metal stent, 12mm in diameter|
16130660|NCT01929538|Device|covered self-expanding biliary metal stent, 10mm in diameter|
16130661|NCT01929512|Drug|HCP1201 750/20mg|750mg Metformin/20mg rosuvastatin fixed dose combination tablet orally in the morning on day1 or day8.
16130662|NCT01929512|Drug|Metformin SR 750mg|Co-administration of Metformin 750mg and Rosuvastatin 20mg orally in the morning on day1 or day8.
16130663|NCT01929512|Drug|Rosuvastatin 20mg|Co-administration of Metformin 750mg and Rosuvastatin 20mg orally in the morning on day1 or day8.
16130664|NCT01929499|Biological|cytokine-induced killer cells|
16130665|NCT01929486|Biological|Mogamulizumab|Mogamulizumab 0.1mg/kg, 0.5mg/kg or 1.0mg/kg will be administered 8 times every week.
16130666|NCT01929460|Drug|Ciprofloxacin|ciprofloxacin oral capsule (one capsule twice a day for 3 days)
16130667|NCT01929460|Other|Placebo (for ciprofloxacin)|oral placebo capsule (one capsule twice a day for 3 days)
16130668|NCT01929434|Other|rehabilitation|Patients only receive rehabilitation of physical therapy and occupational therapy.
16130669|NCT01929434|Biological|stem cell injection|Mesenchymal stem cells derived from umbilical cord are transplanted directly into subarachnoid by Lumbar puncture.
16130670|NCT01929421|Drug|Gemcitabine/S-1|
16130671|NCT01929395|Device|Supine MRI|A limitation of MRI studies of the breast is that MRI exams are performed with the patient prone and the breasts in a pendant position, which is markedly different than the position of the breast when the patient is supine on the Operating Room table. The spatial information the surgeon receives from the prone MRI about the site of the tumor in the breast is hard to mentally translate into the actual site of the tumor in the breast of a supine patient prepared for surgery.
16130672|NCT01929382|Drug|interferon gamma 1b|Standard therapy vs dose titration
16130673|NCT01929356|Procedure|Chest physiotherapy|20 minutes of chest physiotherapy by physiotherapist
16130674|NCT01929343|Drug|lidocaine following cue-induced craving|as described in Arm Description
16130675|NCT01929343|Drug|lidocaine following neutral stimulus|as described in Arm Description
16130676|NCT01929343|Drug|saline|as described in Arm Description
16130677|NCT01929330|Drug|GI198745 0.1 mg|It is available as soft gelatin capsule to be administered as 5 X 0.1 mg capsules as single oral dose with approximately 250 mL of water.
16130678|NCT01929330|Drug|GI198745 0.5 mg|It is available as soft gelatin capsule to be administered as 1 X 0.5 mg capsules as single oral dose with approximately 250 mL of water.
16130679|NCT01929317|Drug|Ropinirole CR 2mg tablet|Ropinirole CR 2mg tablets will be supplied as white oval film-coated tablets.
16130680|NCT01929317|Drug|Ropinirole CR 8mg tablet|Ropinirole CR 8mg tablets will be supplied as white oval film-coated tablets.
16130681|NCT01929317|Drug|Ropinirole CR matching Placebo tablet|Ropinirole CR matching Placebo tablet tablets (containing no active ingredients) indistinguishable in appearance from Ropinirole CR 2 mg tablets.
16130682|NCT01929304|Other|Survey|
16130683|NCT01929291|Biological|Boostrix|Single intramuscular injection
16130684|NCT01929291|Other|Safety data collection|Safety monitoring: recording of adverse events using diary cards and recording of serious adverse events using the latest version of Korea's Post-Marketing Surveillance Serious Adverse Event Reporting Form
16130685|NCT01929278|Drug|CT Gel (clindamycin 1% and tretinoin 0.025%)|Three CT Gel patches were concurrently applied to designated test sites by trained technicians and held in place with hypoallergenic tape. Patches were prepared no longer than 30 minutes prior to application to study subjects. A minimum distance of ¾ of an inch from patch pad to patch pad was maintained on a subject's back. Approximately 24 ±1 hours after patch application, test patches were removed by trained technicians. Patch sites were evaluated for signs of inflammation according to procedures.
16130686|NCT01929278|Other|Vehicle gel patch|Three vehicle gel patches were concurrently applied to designated test sites by trained technicians and held in place with hypoallergenic tape. Patches were prepared no longer than 30 minutes prior to application to study subjects. A minimum distance of ¾ of an inch from patch pad to patch pad was maintained on a subject's back. Approximately 24 ±1 hours after patch application, test patches were removed by trained technicians. Patch sites were evaluated for signs of inflammation according to procedures. 2. Vehicle gel contained the identical ingredients and packaging as CT Gel but without the active ingredients. All vehicle gel used during the study was from batch ZLU C.
16130687|NCT01929278|Other|Blank patch|Three blank patches were concurrently applied to designated test sites by trained technicians and held in place with hypoallergenic tape. Patches were prepared no longer than 30 minutes prior to application to study subjects. A minimum distance of ¾ of an inch from patch pad to patch pad was maintained on a subject's back. Approximately 24 ±1 hours after patch application, test patches were removed by trained technicians. Patch sites were evaluated for signs of inflammation according to procedures. 3. Occlusive patches consisted of a non-woven cotton pad (Webril [approximately 2 cm x 2 cm]) covered and secured on all sides by an occlusive hypoallergenic tape (approximately 4 cm x 4 cm).
16130688|NCT01929265|Drug|Bendamustine|"INDUCTION PHASE
~Rituximab - Bendamustine (RB): cycles 1 to 4 (0, 4, 8, 12 week):
~Rituximab: 375 mg/sqm iv, day 1*
~Bendamustine: 90 mg/sqm iv, days 1-2 or days 2-3 according to istitutional/patient/physician choice
~Repeat cycles every 28 days for a total of 4 cycles
~*In cycle 1, in order to avoid tumor lysis syndrome, Rituximab will be given on day 8.
~CONSOLIDATION PHASE
~Rituximab - Bendamustine (RB): cycles 5 to 6 (16, 20 week):
~Rituximab: 375 mg/sqm iv day 1
~Bendamustine: 90 mg/sqm iv days 1-2 or days 2-3 according to istitutional/patient/physician choice
~Rituximab two monthly doses
~Rituximab: 375 mg/sqm iv week 24 and 28"
16130689|NCT01929252|Drug|Dexmedetomidine|2mcg.kg-1 dexmedetomidine wound infiltration
16130690|NCT01929252|Drug|Levobupivacaine|0.25% levobupivacaine (40ml) wound infiltration
16130691|NCT01929239|Drug|Anti-PSMA Designer T Cells|
16130692|NCT01929226|Biological|ETI-204|Monoclonal Antibody
16130693|NCT01929226|Other|Placebo|Placebo for ETI-204
16130694|NCT01929213|Drug|Udenafil|Udenafil is administered
16130695|NCT01929213|Drug|Bosentan|Bosentan is administered
16130696|NCT01929213|Drug|Udenafil/Bosentan|Udenafil and Bosentan are administered
16130697|NCT01929200|Drug|1-year treatment with icotinib|Icotinib is administered orally with a dose 125 mg 3 times daily within 4-6 weeks after operation for 1 year.
16130698|NCT01929200|Drug|2-year treatment with icotinib|Icotinib is administered orally with a dose 125 mg 3 times daily within 4-6 weeks after operation for 2 years.
16130699|NCT01929187|Drug|Phytonail|
16130700|NCT01929187|Drug|Loceryl|
16130701|NCT01929161|Drug|Oxytocin|24 International Units
16130702|NCT01929161|Drug|Placebo (for oxytocin)|intranasal spray manufactured to mimic oxytocin nasal spray
16130703|NCT01929161|Behavioral|Lovingkindness Meditation|
16130704|NCT01929161|Behavioral|Mindfulness Meditation|
16130705|NCT01929148|Procedure|Prophylactic bilateral salpingectomy|Salpingectomy will be performed by coagulation and section of the tube, beginning from the very distal fimbrial end, carefully preserving the ovarian vascularization, and proceeding toward the uterine cornu
16130706|NCT01929148|Procedure|Laparoscopic myomectomy without PBS|Standard laparoscopic myomectomy without salpingectomy
16130707|NCT01929135|Drug|Medicated 2% atorvastatin dentifrice|Non surgical periodontal therapy accompanied by medicated 2% atorvastatin dentifrice (20 mg per ml) 2 times a day for two minutes each time, for 30
16130708|NCT01929135|Drug|Non-medicated dentifrice|Non surgical periodontal therapy accompanied by non medicated dentifrice 2 times a day for two minutes each time, for 30 days.
16130709|NCT01929122|Dietary Supplement|Placebo-Control Meals and Snacks|
16130710|NCT01929122|Dietary Supplement|Cooked Navy Bean Powder Meals and Snacks|
16130711|NCT01929122|Dietary Supplement|Rice Bran Meals and Snacks|
16130712|NCT01929109|Drug|LY2409021|Administered orally
16130713|NCT01929096|Drug|Compound Edaravone Injection|
16130714|NCT01929096|Drug|Edaravone Injection|
16130715|NCT01929083|Drug|Progesterone|Subjects will receive oral progesterone 400 mg (two x 200 mg capsules) once daily every evening for 7 days
16130716|NCT01929083|Drug|Placebo|Subjects will receive oral placebo two capsules once daily every evening for 7 days
16130717|NCT01929083|Drug|Ibutilide|Ibutilide 0.003 mg/kg administered to all subjects to moderately lengthen the QT interval
16130718|NCT01929070|Drug|HCP1007|
16130719|NCT01929070|Drug|Omarco and Crestor|
16130720|NCT01929057|Procedure|Skin biopsy|4-millimeter punch biopsies will be performed on all subjects (acne patients and healthy controls)
16130721|NCT01929057|Procedure|Blood draw|Approximately half a tube of blood will be drawn from all participants in the study
16130722|NCT01929044|Drug|654-II (anisodamine)|10mg injection
16130723|NCT01929044|Drug|Buscopan® (hyoscine butylbromide)|20mg injection
16130724|NCT01929031|Drug|ibuprofen + caffeine|FDC tablet
16130725|NCT01929031|Drug|ibuprofen|tablet.
16130726|NCT01929031|Drug|ibuprofen|tablet
16130727|NCT01929031|Drug|caffeine|tablet
16130728|NCT01929031|Drug|ibuprofen + caffeine|Fixed Dose Combination (FDC) tablet
16130729|NCT01929031|Drug|placebo|tablet
16130730|NCT01929031|Drug|placebo|tablet
16130731|NCT01929031|Drug|caffeine|tablet
16130732|NCT01929031|Drug|ibuprofen|tablet
16130733|NCT01929031|Drug|ibuprofen + caffeine|FDC tablet
16130734|NCT01929018|Behavioral|Exercise|Exercise will target muscle strength and joint mobility impairments and will be delivered over a 12 week period.
16130735|NCT01929018|Behavioral|Walking Program|A walking program will be established with the goal of participants walking at least five days per week. Duration of program is 12 weeks.
16130736|NCT01929018|Behavioral|Health Self-Management Support|Health self-management support will be delivered with weekly meetings between the researcher and participant over a 12-week period.
16130737|NCT01929005|Other|Comprehensive Care|Patients will receive comprehensive medical care from their CCP in clinic and the hospital. For most patients, the ambulatory care provided by the CCP will be in our onsite medicine clinic, but for some patients with subspecialty needs the CCP may be a specialist who will care for the patient in a nearby ambulatory setting (e.g., nursing home, dialysis facility). The CCPs will also supervise the nurses, pharmacists, social workers, and others who are part of the multi-disciplinary care team. Daytime inpatient care will be provided by CCPs in conjunction with our inpatient advanced practice nurses (APNs). These APNs now work with our hospitalists, so they are experienced providing hospital care.
16130738|NCT01928992|Device|3D|subjects that underwent 3D mammography
16130739|NCT01928992|Device|2D|those subjects that underwent 2D mammography
16130740|NCT01928979|Other|no drug|Patients who suffered from hemodynamically stable nonvalvular AF or atrial flutter and had a diagnosed LA/ LAA thrombus between January 1st, 2011 and December 31st, 2012
16130741|NCT01928966|Other|Pumpkin Seeds|Participants will be asked to consume 1.5 ounces of raw, unsalted pumpkin seeds per day. The 1.5 ounces will be split in to two servings (each 0.75 ounces).
16130742|NCT01928940|Drug|dabrafenib|150 mg twice daily
16130743|NCT01928940|Drug|trametinib|2 mg once daily
16130744|NCT01928927|Drug|Telmisartan|Participants received Telmisartan 40 mg daily during weeks 0-4 followed by telmisartan 80 mg daily during weeks 5-48.
16130745|NCT01928914|Drug|Tafenoquine 300mg|Single dose of Tafenoquine give on Day 3 only
16130746|NCT01928914|Drug|Tafenoquine 600mg|Single dose of Tafenoquine given on Day 3 only
16130747|NCT01928914|Drug|Tafenoquine 1200mg|400mg Dose of Tafenoquine given on each of the three consecutive dosing days
16130748|NCT01928914|Drug|moxifloxacin|moxifloxacine given on Day 3 only
16130749|NCT01928914|Drug|Placebo for Tafenoquine|Placebo given on all three days to all groups except for group 5 on Day 3
16130750|NCT01928914|Drug|Placebo for moxifloxaxin|Placebo for moxifloxacin, given to all groups on all days except for Group 3 on Day 3
16130751|NCT01928901|Drug|administration of Sinupret|
16130754|NCT01928901|Drug|administration of Bronchipret Placebo|
16130755|NCT01928888|Drug|Talcid (Hydrotalcite, BAY4516H)|2 tablets hydrotalcite (2x500mg) 1000mg and 1 capsule placebo to famotidine
16130756|NCT01928888|Drug|Famotidine|2 tablets placebo to hydrotalcite and 1 capsule famotidine 10 mg
16130757|NCT01928888|Drug|Placebo|2 tablets placebo to hydrotalcite and 1 capsule placebo to famotidine
16130758|NCT01928875|Device|AoA Monitoring|Monitoring with Entropy and SPI parameters during surgery
16130759|NCT01928875|Device|Routine (Standard) Anesthesia Monitoring|Standard of care monitoring
16130760|NCT01928862|Drug|Prepopik® ½ Sachet x 2 (9-12 years)|
16130761|NCT01928862|Drug|Prepopik® 1 Sachet x 2 (9-12 years)|
16130762|NCT01928862|Drug|Oral polyethylene glycol (PEG) based preparation (9-12 years)|
16130763|NCT01928862|Drug|Prepopik® 1 Sachet x 2 (13-16 years)|
16130764|NCT01928862|Drug|Oral polyethylene glycol (PEG) based preparation (13-16 years)|
16130765|NCT01928849|Drug|Valproic Acid|"Intervention patients will receive standard regional anesthesia catheters (either peripheral nerve or epidural catheter), anesthetic management and oral valproic acid 250mg preoperatively, then three times per day for either 6 days post-operatively or until discharge from the hospital."
16130766|NCT01928849|Other|Cherry Syrup|Intervention arm patients will receive standard regional anesthesia catheters (either peripheral nerve or epidural catheter), anesthetic management, and valproic acid 250mg preoperatively, and then three times per day for 6 days post-operatively.
16130767|NCT01928823|Behavioral|CBT|12 sessions of CBT (cognitive behavioral therapy) with psychoeducation and in-vivo exposure
16130768|NCT01928823|Drug|D-Cycloserine|Administered for three times (50mg, oral) directly after exposure
16130769|NCT01928810|Behavioral|Cognitive Behavioural Therapy|12 sessions of CBT including psychoeducation, interoceptive exposure and in-vivo exposure
16130770|NCT01928797|Device|Cardiac output monitor data|The availability of cardiac output monitor provides additional hemodynamic indices that may help guide anesthesiologists to better select vasopressors
16130771|NCT01928784|Device|Radial Extracorporeal Shock Wave Therapy 2000 impulses|Radial Extracorporeal Shock Wave Therapy, 13 Hz, 2.5 Bar, 2000 impulses
16130772|NCT01928784|Device|Radial Extracorporeal Shock Wave Therapy 4000 impulses|Radial Extracorporeal Shock Wave Therapy, 13 Hz, 2.5 Bar, 4000 impulses
16130773|NCT01928771|Biological|Benralizumab|Benralizumab subcutaneously on study week 0 until study week 44 inclusive.
16130774|NCT01928771|Biological|Placebo|Placebo subcutaneously on study week 0 until study week 44 inclusive.
16130775|NCT01928758|Drug|Reduced Nicotine Content Cigarettes|Research cigarettes will have gradually reduced nicotine content
16130776|NCT01928758|Drug|Usual Nicotine Content Cigarettes|Usual Nicotine Content Cigarettes
16130777|NCT01928732|Behavioral|Cognitive Processing Therapy (CPT)|CPT consists of cognitive therapy and a written trauma narrative. Patients are taught to challenge their beliefs through Socratic questioning and the use of daily worksheets. The initial focus is on beliefs such as denial and self-blame, and then shifts to overgeneralized beliefs about self and the world. Patients process their trauma directly by writing a narrative of their traumatic event(s) that they read to themselves and to therapists. The typical protocol consists of 12 1-hr sessions. In this study, the 12-session protocol will be followed, but participants who improve more rapidly may finish in 10 sessions and those who improve more slowly may receive up to 2 additional sessions to continue working on stuck points with challenging beliefs worksheets.
16130778|NCT01928732|Behavioral|Prolonged Exposure (PE)|"PE is a manualized, 90-minute, 8-15 week treatment program based on emotional processing theory, which posits that anxiety disorders, including PTSD, reflect pathological fear structures in which emotional and cognitive associations among different elements do not accurately represent reality and renders the individual dysfunctional and distressed. PE is designed to correct erroneous connections in the targeted memory structure. PTSD sufferers typically experience two key pathological emotional response sets and related cognitions: The world is an utterly dangerous place, and I am completely incompetent and unable to cope with stress. In this study, the 12-session protocol will be followed, but participants improve more rapidly may finish in 10 sessions and those who improve more slowly may have up to 2 additional sessions to continue working on exposure."
16130779|NCT01928719|Drug|Reduced Nicotine Content Cigarettes|Cigarettes contain 11.6, 7.4, 3.3, 1.4, 0.7, and 0.2 mg nicotine per cigarette
16130780|NCT01928719|Drug|Same Nicotine Content Cigarettes|about 11.6 mg nicotine per cigarette
16130781|NCT01928706|Other|Denture liner Mucopren Soft; Group 1|Complete denture wearers had their existing mandibular dentures relined with a soft silicone-based denture liner (Mucopren Soft; Group 1; n=22)
16130782|NCT01928706|Other|Denture liner Kooliner; Group 2|Complete denture wearers had their existing mandibular dentures relined with a hard acrylic resin based denture liner (Kooliner; Group 2;n=22) with chairside procedures.
16130783|NCT01928693|Drug|Besivance 0.6% Ophthalmic Suspension|Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours.
16130784|NCT01928693|Drug|Zymaxid 0.5% Ophthalmic Solution|Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours.
16130785|NCT01928693|Drug|Vigamox 0.5% Ophthalmic Solution|Drop to be applied in affected eye initially every hour for the first 48 hours then doses will be reduced at each subsequent visit by 50% if patient continues to show a reduction in size of 25% from the previous visit up to every 4 hours. If subject dose has been reduced to every 4 hours at visit 3 and shows an additional reduction size of 25% at visit 4, then they will be reduced to every 6 hours.
16130786|NCT01928680|Drug|Cisplatin/Capecitabine|Cisplatin/Capecitabine: Capecitabine 1000mg/m2 orally Bid on day 1 to day 14 plus Cisplatin 75mg/m2 on day1 of each 21 day cycle, until progression or untolerable toxicity
16130839|NCT01928433|Drug|Ciprofloxacin 500 mg oral twice daily|Administered as two 250 mg capsules.
16131324|NCT01924650|Drug|PH-797804|Tablet, 6 mg, single dose
16130787|NCT01928667|Other|Whole saliva sample|Both case and control group will be approached to consider to give permission to sample saliva. This is not obligatory. Collected samples will be stored for future DNA research.
16130788|NCT01928654|Device|Micropulse laser treatment|Device for subthreshold treatment of the retina, by decomposing a continuos wave of laser in micropulses, with 5% duty cycle, 200 milliseconds, 100 microns, and power adjusted according to patient's diopter transparency and pigmentation.
16130789|NCT01928654|Device|Laser modified ETDRS|Device for visible treatment of the retina, with direct treatment of microaneurysms or grid pattern covering the area of retinal edema.
16130790|NCT01928628|Drug|Lercanidipine 10mg|
16130791|NCT01928628|Drug|Lercanidipine10mg /Valsartan 80mg|
16130792|NCT01928628|Drug|Lercanidipine 10mg /Valsartan 160mg|
16130793|NCT01928628|Drug|Lercanidipin 10mg Placebo|
16130794|NCT01928628|Drug|Lercanidipine10mg /Valsartan 80mg Placebo|
16130795|NCT01928628|Drug|Lercanidipine 10mg /Valsartan 160mg Placebo|
16130796|NCT01928615|Drug|Trastuzumab - intravenous solution|Trastuzumab was supplied as a powder to be reconstituted as a solution for intravenous infusion.
16130797|NCT01928615|Drug|Trastuzumab - subcutaneous solution|Trastuzumab was supplied as a solution for subcutaneous injection.
16130798|NCT01928615|Drug|Chemotherapy|Standard chemotherapy for early breast cancer.
16130799|NCT01928602|Behavioral|TherAppy Language App|Language TherAppy combines the receptive exercises of Comprehension TherAppy and Reading TherAppy with the expressive training of Naming TherAppy and Writing TherAppy. The app uses the same core functional vocabulary (nouns, verbs, & adjectives) and over 700 clear pictures. Each app tracks data, sends professional e-mailed reports, and has built-in levels, cues, and options.
16130800|NCT01928602|Behavioral|Mind-Games|A mind-game app is said to improve brain functioning at any age. The chosen app will give feedback such as score history, and progress reports. Tasks will focus on attention, memory spatial awareness and executive function.
16130801|NCT01928589|Radiation|PBI with sequential chemotherapy|270 cGy x15
16130802|NCT01928589|Other|PBI with concurrent chemotherapy|270 cGy x15 concurrent with chemotherapy of the treating medical oncologist's choice
16130803|NCT01928576|Drug|Azacitidine|
16130804|NCT01928576|Drug|Entinostat|
16130805|NCT01928576|Drug|Nivolumab|
16130806|NCT01928563|Drug|Dapoxetine|
16130807|NCT01928563|Drug|Udenafil|
16130808|NCT01928563|Drug|Udenafil+Dapoxetine|
16130809|NCT01928537|Drug|rigosertib sodium|
16130810|NCT01928524|Drug|DOS2w Dose level 1A|Docetaxel (30 mg/m2), Oxaliplatin (70 mg/m2) and S1 (60 mg/2) will be given every 2 weeks. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered.
16130811|NCT01928524|Drug|DOS2w Dose level 2A|Docetaxel (30 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2 weeks. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered.
16130812|NCT01928524|Drug|DOS2w Dose level 3A|Docetaxel (40 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2 weeks. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered.
16130813|NCT01928524|Drug|DOS2w Dose level 4A|Docetaxel (50 mg/m2), Oxaliplatin (70 mg/m2) and S1 (70 mg/2) will be given every 2 weeks. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered.
16130814|NCT01928524|Drug|DOS3w Dose level 1B|Docetaxel (40 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 3 weeks. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered.
16130815|NCT01928524|Drug|DOS3w Dose level 2B|Docetaxel (50 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 3 weeks. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered.
16130816|NCT01928524|Drug|DOS3w Dose level 3B|Docetaxel (60 mg/m2), Oxaliplatin (100 mg/m2) and S1 (50 mg/2) will be given every 3 weeks. In total there is 5 dose levels and if no patients experience DLT on a given level, next dose level will be administered.
16130817|NCT01928511|Drug|peg-interferon alpha 2b, 1.5mcg/kg s/c given weekly|
16130818|NCT01928511|Drug|Nucleos(t)ide analogue therapy|
16130819|NCT01928498|Device|Paclitaxel Eluting Balloon Angioplasty|
16130820|NCT01928498|Device|Percutaneous Transluminal Angioplasty (PTA)|
16130821|NCT01928485|Other|active surveillance|Undergo active surveillance
16130822|NCT01928485|Drug|Sunphenon|Given PO
16130823|NCT01928485|Other|laboratory biomarker analysis|Correlative studies
16130824|NCT01928485|Other|Questionnaire Administration|Ancillary studies
16130825|NCT01928472|Biological|H7N9c low dose with adjuvant|
16130826|NCT01928472|Biological|H7N9c medium dose with adjuvant|
16130827|NCT01928472|Biological|H7N9c high dose with adjuvant|
16130828|NCT01928472|Biological|H7N9c high dose without adjuvant|
16130829|NCT01928459|Drug|BGJ398|BGJ398 will be administered orally once daily for the first 21 days of each 28-day cycle.
16130830|NCT01928459|Drug|BYL719|BYL719 will be administered orally once daily on each day of the 28-day cycle.
16130831|NCT01928446|Drug|Lithium|Lithium in the form of extended release lithium carbonate. Subjects will be started on 600 mg/day (300mg bid) until steady state at target plasma levels between 0.6 and 0.8 meq/liter is achieved. The lowest dose will be 300 mg/day. Lithium will be prescribed for the duration of follow-up (1 year).
16130832|NCT01928446|Drug|Placebo|Oral placebo tablets will be administered for the duration of follow-up (1 year).
16130833|NCT01928433|Drug|Finafloxacin 800 mg i.v. once daily|Infused over 60 mins [i.v. pump]) for at least 3 days.
16130834|NCT01928433|Drug|Finafloxacin placebo i.v. once daily|Infused over 60 mins [i.v. pump]) for at least 3 days.
16130835|NCT01928433|Drug|Finafloxacin 800 mg tablets once daily|Administered as four 200 mg tablets
16130836|NCT01928433|Drug|Finafloxacin placebo tablets once daily|Administered as four tablets
16130837|NCT01928433|Drug|Ciprofloxacin 400 mg i.v. twice daily|Infused over approximately 60 mins [i.v. pump]) for at least 3 days
16130838|NCT01928433|Drug|Ciprofloxacin placebo i.v. twice daily|Infused over approximately 60 mins [i.v. pump]) for at least 3 days
16131032|NCT01926860|Biological|Hepatitis A vaccine|
16130840|NCT01928433|Drug|Ciprofloxacin placebo oral twice daily|Administered as two capsules.
16130841|NCT01928420|Drug|Drug: NIC5-15|A natural product, found in many foods and plants with mild insulin sensitizing effects
16130842|NCT01928420|Drug|Placebo|Subjects with Alzheimer's Disease placebo comparator
16130843|NCT01928407|Drug|DARUNAVIR|The patient included will receive their first antiretroviral regimen included the darunavir treatment in combination with 2 others molecules
16130844|NCT01928407|Drug|ATAZANAVIR|The patient included will receive their first antiretroviral regimen included the atazanavir treatment in combination with 2 others molecules
16130848|NCT01928381|Drug|AZD5213 + pregabalin|Double blind Investigational drug AZD5213 (capsules) given in combination with pregabalin (capsules)
16130849|NCT01928381|Drug|Placebo|Double blind placebo capsules to match AZD5213 and pregabalin
16130850|NCT01928381|Drug|pregabalin capsules|Double blind pregabalin capsules to match AZD5213 and placebo
16130851|NCT01928368|Drug|AMG 282|Single dose either subcutaneously or intravenously on day 1.
16130852|NCT01928368|Drug|AMG 282 Matching Placebo|Single dose of matching AMG 282 placebo either subcutaneously or intravenously on day 1.
16130853|NCT01928342|Drug|Coenzyme A|Coenzyme A 400mg per day
16130854|NCT01928342|Drug|Placebo|Capsule without coenzyme A.
16130855|NCT01928329|Drug|Exenatide (Bydureon®)|
16130856|NCT01928329|Drug|Placebo|
16130857|NCT01928316|Drug|Mizolastine domestic (made in China)|Healthy male volunteers will receive 10 mg domestic (made in China) mizolastine tablets on Day 1 and Day 8
16130858|NCT01928316|Drug|Mizolastine (imported)|Healthy male volunteers will receive 10 mg imported mizolastine tablets on Day 1 and Day 8
16130859|NCT01928290|Drug|Irinotecan|
16130860|NCT01928290|Drug|Trastuzumab|
16130861|NCT01928290|Drug|Oxaliplatin|
16130862|NCT01928290|Drug|Leucovorin|
16130863|NCT01928290|Drug|Fluorouracil|
16130864|NCT01928264|Behavioral|Physical activity|
16130865|NCT01928251|Behavioral|Informed early monetary incentive|"Participants will be informed at 1 week after the baseline recruitment about the monetary incentive of quitting.
~Apart from the different arrangement of monetary incentives for the three RCT arms, all participants of the Quit to Win Contest will receive self-help materials on smoking cessation, including a COSH-developed self-help smoking cessation booklet, a health education card, and the quitline (i.e. 1833183). The theory-based health education card (pocket size), which guided by the HAPA, will be developed and distributed to the participants as a reminder and a 'homework assignment' to be completed at home, for the purpose of enhancing their intention and practice of the suggested behaviour (quitting smoking)."
16130866|NCT01928251|Behavioral|Uninformed early monetary incentive|"Participants will be informed at 3 months after the baseline recruitment about the monetary incentive of quitting.
~Apart from the different arrangement of monetary incentives for the three RCT arms, all participants of the Quit to Win Contest will receive self-help materials on smoking cessation, including a COSH-developed self-help smoking cessation booklet, a health education card, and the quitline (i.e. 1833183). The theory-based health education card (pocket size), which guided by the HAPA, will be developed and distributed to the participants as a reminder and a 'homework assignment' to be completed at home, for the purpose of enhancing their intention and practice of the suggested behaviour (quitting smoking)."
16130867|NCT01928238|Device|Noninvasive neurally adjusted ventilatory assist (NIV-NAVA).|
16130868|NCT01928238|Device|Noninvasive pressure support ventilation (NPSV)|
16130869|NCT01928225|Biological|Human Papillomavirus vaccine|The participants receive the qHPV vaccine at entry, week 4 and week 26
16130870|NCT01928212|Device|Optical coherence tomography|
16130871|NCT01928199|Drug|Sitagliptin|
16130872|NCT01928199|Drug|Placebo|
16130873|NCT01928186|Drug|Fluorothymidine F-18|Undergo FLT PET
16130874|NCT01928186|Procedure|Positron Emission Tomography|Undergo FLT PET
16130875|NCT01928186|Other|Laboratory Biomarker Analysis|Correlative studies
16130876|NCT01928186|Drug|Run-in (short pre-surgery course) of endocrine-targeted therapy|Patients undergo run-in (short pre-surgery course) of endocrine-targeted therapy with aromatase inhibitor between the two (baseline and repeat) FLT PET scans. This is not an experimental therapy. This is a standard of care therapy that patients will continue after surgery, when the study is completed.
16130877|NCT01928173|Behavioral|Abbreviated cognitive behavioral therapy|see arm description
16130878|NCT01928173|Behavioral|Sleep education/sleep hygiene|see arm description
16130879|NCT01928160|Drug|pemetrexed disodium|Given IV
16130880|NCT01928160|Drug|carboplatin|Given IV
16130881|NCT01928160|Drug|cisplatin|Given IV
16130882|NCT01928160|Drug|erlotinib hydrochloride|Given PO
16130883|NCT01928160|Other|laboratory biomarker analysis|Correlative studies
16130884|NCT01928147|Drug|PPI-383|
16130885|NCT01928147|Drug|Placebo|
16130886|NCT01928134|Dietary Supplement|Vit K2+ Vit D3+ calcium carbonate (CaCO3)|
16130887|NCT01928134|Dietary Supplement|Vit K2+CaCO3|
16130888|NCT01928121|Other|Care provided by AF expert program|
16130889|NCT01928108|Behavioral|iPhone Application|"The iPhone application waterlogged will be used by participants using and iPhone cellular device. This application will be used to track daily fluid intake for 1 week."
16130890|NCT01928108|Behavioral|Android Application|"The Android application water my body will be used by participants using an Android cellular device. This application will be used to track daily fluid intake for 1 week."
16130891|NCT01928082|Drug|Transdermal estradiol|4 weeks of Vivelle-Dot 0.05 mg/day followed by 4 weeks of Vivelle-Dot 0.10 mg/day
16130892|NCT01928069|Drug|Torrent's Montelukast Sodium Tablets 10 mg|
16130893|NCT01928056|Drug|Torrent's Montelukast Sodium Tablets 10 mg|
16130894|NCT01928043|Drug|Curcumin|
16130895|NCT01928030|Biological|recombinant human hyaluronidase|Given SC
16130896|NCT01928004|Device|Implant placement|Participants received two Straumann Standard Implants® in the interforaminal region using the recommended surgical protocol. The implants were loaded using Locator® attachments after six to eight weeks healing time by transforming the existing lower denture to an IOD.
16130897|NCT01928004|Procedure|Conventional reline|conventional reline of the existing mandibular complete denture
16130898|NCT01927991|Behavioral|iCBT (internet-based, cognitive-behavioural therapy)|The intervention is based on cognitive-behavioural therapy (CBT) and is offered as a self-help and provided over the internet. Participants work on their own on different modules which give information about tinnitus and the associated symptoms and provide instructions for practical exercises.
16130899|NCT01927965|Drug|Minnelide™ 001|Minnelide™ will be given as a single agent intravenously as a 30-minute infusion daily x 21 days followed by a 7-day rest period. One cycle will equal 28 days.
16130900|NCT01927952|Procedure|Kirschner wire|Surgical fixation utiliziing Kirschner wire
16130901|NCT01927952|Procedure|Integra IPP-On PIP Fusion System|surgical fixation utilizing the Integra IPP-On PIP Fusion System
16130902|NCT01927952|Procedure|Stryker Smart-Toe Implant|surgical fixation utilizing the Stryker Smart-Toe Implant
16130903|NCT01927926|Dietary Supplement|Whey-protein & polydextrose snack|Subjects will consume one snack bar as a between-meal mid-morning snack daily for 15 days.
16130904|NCT01927926|Dietary Supplement|Control snack|Subjects will consume one snack bar as a between-meal mid-morning snack daily for 15 days.
16130905|NCT01927913|Drug|SPD602|32, 50 or 75 mg/kg/day BID, capsule
16130906|NCT01927913|Drug|Deferasirox|Per approved country specific label
16130907|NCT01927900|Dietary Supplement|HMO|
16130908|NCT01927900|Dietary Supplement|Glucose|
16130909|NCT01927887|Drug|Ferumoxytol|Ferumoxytol will be administered as an undiluted intravenous injection dose of 6 mg/kg body weight, up to a maximum dose of 510 mg, delivered at a rate of up to 1ml/sec. Each ml of the supplied agent contains 30 mg of elemental iron and the dose will be titrated based on patients body weight in kilograms; for example at a dose of 6 mg/kg, the dose for a 50 kg person will be 50 x 6 = 300 mg. As the vial contains 30 mg/ml, 10 cc of the dose will correspond to the required 300 mg dose.
16130910|NCT01927887|Device|Nanoparticle MRI|Each subject will have one MRI scan. At the initial pre-scan visit, the subject will receive the ferumoxytol infusion. Within 48-72 hours after ferumoxytol infusion, a scan will be performed. Subjects will be imaged at Massachusetts General Hospital using commercial 3.0T imaging systems using dedicated neck coil and approved imaging protocols. The MR imaging will include conventional T1 and T2 weighted spin echo and 3 D gradient echo sequences.
16130911|NCT01927874|Procedure|Infiltration|injection of local anesthetic, associated with general anesthesia
16130912|NCT01927874|Procedure|Spinal block|injection of anesthetic
16130913|NCT01927874|Drug|Bupivacaine|10ml 0.5% bupivacaine.
16130914|NCT01927874|Drug|10 mg of hyperbaric 0.5% bupivacaine|Spinal punction and injection of local anesthetic
16130915|NCT01927861|Drug|somatropin|Administered subcutaneously (s.c., under the skin) in a daily regimen for at least 104 weeks. Subject will be offered to continue treatment for another 104 weeks.
16130916|NCT01927848|Dietary Supplement|Rosehip|Rosehip powder made from the fleshy orange walls (hypanthiums) of Rosehips with the achenes (seeds) removed, from the wild growing species Dog Rose (Rosa canina L.), in addition to vitamin C as sodium ascorbate. The active ingredient complex is Rosenoids®, Vitamin C, flavonoids, carotens, triterpene acids, and galactolipids. Rosenoids® is the registered name for the bioactive complex isolated from the rose-hip (Rosa canina) used in RH01. It is being supplied as capsules containing 750 mg of the Rosehip powder and 26.7 mg vitamin C.
16130917|NCT01927848|Dietary Supplement|Placebo|The placebo used in this study will be identical to the Rosehip capsules in both appearance and taste, except that it will not contain the active Rosehip powder ingredient Rosenoids® or vitamin C.
16130918|NCT01927835|Biological|DNA-HIV-PT123 vaccine|4 mg of DNA encoding clade C ZM96 Gag and gp140, CN54 Pol-Nef, administered IM
16130919|NCT01927835|Biological|NYVAC-HIV-PT1 vaccine|≥ 5x10^6 PFU/ml encoding clade C ZM96 gp140 for a planned maximum dose of 1.2x10^8 PFU/ml; administered IM
16130920|NCT01927835|Biological|NYVAC-HIV-PT4 vaccine|≥ 5x10^6 PFU encoding ZM96 Gag and CN54 Pol-Nef, administered IM for a planned maximum dose of 1.1x10^7 PFU/ml; administered IM
16130921|NCT01927835|Biological|AIDSVAX B/E vaccine|300 mcg of subtype B (MN) HIV gp120 glycoprotein and 300 mcg of subtype E (A244) HIV gp120 glycoprotein absorbed onto 600 mcg of aluminum hydroxide gel adjuvant, administered IM
16130922|NCT01927835|Biological|Placebo for DNA/NYVAC/AIDSVAX|Sodium Chloride for injection, 0.9%; administered IM
16130923|NCT01927757|Biological|Etanercept|Administered by subcutaneous injection
16130924|NCT01927757|Drug|Methotrexate|Background methotrexate at least 15 mg weekly
16130925|NCT01927744|Drug|Docetaxel|75 mg/m2 by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles.
16130926|NCT01927744|Drug|Erlotinib|150 mg by mouth daily continuously until the day before surgery.
16130927|NCT01927744|Other|Placebo|150 mg by mouth daily continuously until the day before surgery.
16130928|NCT01927744|Behavioral|Questionnaires|Questionnaire completion at baseline, 14 days after treatment completion, and 8 weeks after surgery.
16130929|NCT01927744|Behavioral|Phone Call|Phone call made to patient 1 time each year after the end of treatment visit.
16130930|NCT01927744|Drug|Chemotherapy|Cisplatin 75 mg/m2 or Carboplatin AUC 6 mg.min/ml by vein on Day 1 of each 21 day cycle for a maximum of 3 cycles.
16130931|NCT01927731|Drug|Eltrombopag Olamine|Given PO
16130932|NCT01927731|Other|Laboratory Biomarker Analysis|Correlative studies
16130933|NCT01927718|Drug|Thalidomide|100 mg by mouth daily for 28 days in a 28 day cycle.
16130934|NCT01927718|Drug|Lenalidomide|Lenalidomide continued by mouth at the previous dose of 5 mg daily for 21 days on a 28 day cycle, 5 mg daily for 28 days on a 28 day cycle, 10 mg daily for 28 days on a 28 day cycle, or 15 mg daily for 28 days on a 28 day cycle.
16130935|NCT01927718|Behavioral|Questionnaires|Questionnaire completion at screening, once a month for the first 6 months, then every other month while on study.
16130936|NCT01927705|Biological|FURESTEM-AD Inj.|
16130937|NCT01927692|Other|Skin biopsy|An optional skin biopsy will be performed in up to 5 subjects at baseline and 2 weeks after therapeutic plasma exchange is completed.
16130938|NCT01927692|Other|Single Fiber Electromyography|An optional SFEMG study will be performed at baseline and 2 weeks after therapeutic plasma exchange is completed.
16130939|NCT01927679|Drug|Vitamin E|
16130940|NCT01927679|Drug|Eucerin|Control
16131033|NCT01926847|Drug|Riociguat (Adempas, BAY63-2521)|
16131034|NCT01926847|Drug|Placebo|
16130941|NCT01927666|Dietary Supplement|100mg glucoraphanin|The extent of ITC excretion in urine from a capsule delivered dose of glucoraphanin
16130942|NCT01927640|Drug|Dexmedetomidine|Dexmedetomidine (0.3-0.6 mcg/kg) infusion.
16130943|NCT01927640|Drug|Normal Saline|Normal saline infusion (10 cc)
16130944|NCT01927640|Drug|Intranasal cocaine|Intranasal cocaine (2 mg/kg)
16130945|NCT01927627|Drug|enzalutamide|oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD).
16130946|NCT01927614|Radiation|Cardiac CT|"A 128-slice dual-source CT system will be used (Somatom Definition Flash, Siemens Healthcare, Germany).
~The CT scan protocol will comprise 3 steps.
~Prospectively gated calcium scoring.
~Stress-myocardial CT perfusion.
~Rest Coronary CT angiography and myocardial CT perfusion. Automated computed tomography dose index (CTDIvol) and dose- length-product (DLP) will be collected from the scanner, and effective dose will be calculated using the DLP conversion factor (0.014) for each component of the cardiac CT protocol. Based on local dose audits the predicted dose range will be 3.5 mSv to 8 mSv depending on patient body habitus."
16130947|NCT01927588|Drug|Everolimus+Tacrolimus+Prednisone|Certican, introduced at Day7 post transplant + TACreduced + Steroids.
16130948|NCT01927588|Drug|Mycophenolate+Tacrolimus+Prednisone|Myfortic + Tacrolimus full + Steroids, as control arm.
16130949|NCT01927575|Device|Standard X-Ray + CT|Standard of Care X-Ray Imaging + CT
16130950|NCT01927575|Device|Standard X-Ray + MRI|Standard of Care X-Ray Imaging + MRI
16130951|NCT01927575|Device|TOMO|Fujifilm Digital Radiographic AcSelerate CsI System with Tomosynthesis
16130952|NCT01927562|Device|Fractyl Duodenal Remodeling System|
16130953|NCT01927549|Procedure|Immediate multivessel PCI|
16130954|NCT01927549|Procedure|Culprit Lesion only PCI|
16130955|NCT01927536|Device|White LED Flashlight|white light setting
16130956|NCT01927536|Device|Red/Green Green Dominant LED Flashlight|Green LED light dominant setting
16130957|NCT01927523|Behavioral|BAM|BAM (Becoming a Man), a cognitive-behavioral group therapy intervention.
16130958|NCT01927523|Other|Match|An intensive math tutoring program.
16130959|NCT01927510|Behavioral|Early mobilisation|
16130960|NCT01927497|Procedure|Biological mesh assisted perineal closure|The eAPR procedure will be performed in an identical way as described for the control arm of the study, and this is preferably followed by an omental plasty. The intervention in the experimental arm consists of suturing an acellular biological mesh derived from porcine dermis in the pelvic floor defect (Strattice™, 6x10 cm). The mesh will be sutured at each side of the coccyx or distal sacrum with Prolene or PDS to the discretion of the surgeon. Laterally, the mesh is attached to the remainings of the levator complex and, anteriorly, to the transverse perineal muscle or posterior vaginal wall. A suction drain will be inserted and positioned on top of the mesh. The perineal subcutaneous fat and skin will be subsequently closed in layers similar to primary simple closure as performed in the standard arm.
16130961|NCT01927497|Procedure|Primary perineal closure|The perineal phase of the APR will be performed according to the principles of an extralevator APR, which means that the levator muscles will be laterally transected in order to leave a muscular cuff around the tumour. The coccyx will not be routinely resected, but only if indicated based on surgical exposure or oncological principles. The extent of excision of perineal skin and ischioanal fat will be as limited as oncologically justified. Preferably, an omental plasty is positioned in the pelvic cavity following resection. Closure of the perineum in the control arm consists of stitching the perineal subcutaneous fat together using interrupted Vicryl sutures in one or two layers. Subsequently, the skin will be closed using interrupted sutures according to the preference of the surgeon. Placement of a transabdominal or transperineal drain will be at the discretion of the surgeon.
16130962|NCT01927484|Drug|25 mg/week oral methotrexate tablets|active oral methotrexate drug
16130963|NCT01927484|Drug|25mg/week oral placebo tablets|placebo comparator oral drug
16130964|NCT01927458|Device|Transcranial Direct Current Stimulation|A direct current runs between two electrode positions and affects the excitability of the underlying brain tissue
16130965|NCT01927445|Other|quality improvement toolkit|educational and informatics-based interventions, including brief guideline summary, decision support and audit and feedback
16130966|NCT01927419|Drug|Nivolumab|
16130967|NCT01927419|Drug|Ipilimumab|
16130968|NCT01927419|Drug|Placebo|Matching nivolumab
16130969|NCT01927406|Drug|Prostaglandin Analog|The first choice drug from group of Prostaglandin Analogues will be bimatoprost, if patient will suffer from any side effect of this drug another drug from this group will be administer. If patient turned out to cannot tolerate the prostaglandin analog therapy then the exclusion criteria will be met.
16130970|NCT01927406|Drug|Timolol|Timolol topical eye drop will be administered in Prostaglandin Analog vs Timolol arm only, in patients with elevated intraocular pressure in both eyes.
16130971|NCT01927393|Other|palliative care|Receive PCPI
16130972|NCT01927393|Behavioral|educational intervention|Receive education sessions
16130973|NCT01927393|Procedure|quality-of-life assessment|Ancillary studies
16130974|NCT01927393|Other|questionnaire administration|Ancillary studies
16130975|NCT01927393|Behavioral|telephone-based intervention|Receive telephone contacts
16130976|NCT01927380|Other|steep trendelenburg position with pneumoperitoneum|ANS activity and baroreflex modulation is assessed at (i) baseline; (ii) after induction of general anesthesia; (iii) after steep trendelenburg position (head down at 25 degrees); (iv) after induction of pneumoperitoneum and (v) after removal of trendelenburg and pneumoperitoneum
16130977|NCT01927367|Other|Clinical Decision Support System for AF|A web-based clinical decision support system, computerizing the Canadian AF clinical guidelines and best-practice approaches, to support primary care providers and patients in optimizing and standardizing AF care.
16130978|NCT01927341|Drug|MEK162|Tablet for oral use, 45 mg (three 15 mg tablets), BID
16130979|NCT01927341|Drug|Panitumumab|Intravenous infusion, 20mg/ml concentrate solution for infusion, Q2W (Days 1 and 15 of every cycle)
16130980|NCT01927328|Drug|Iron isomaltoside 1000|
16130981|NCT01927315|Drug|Fenofibrate 145 mg|Tablets of Fulcrosupra 145 mg to be taken at 8.00 am daily for 12 weeks.
16130982|NCT01927315|Drug|Placebo|Oral Placebo tablets once daily
16130983|NCT01927302|Behavioral|Treatment Focusing on Naming Objects|Treatment will be administered from week 0 until week 12.
16131325|NCT01924650|Drug|PH-797804|Tablet, 6 mg, single dose
16130984|NCT01927302|Behavioral|Treatment Focusing on Improving Spelling Abilities|Treatment will be administered from week 0 until week 12.
16130985|NCT01927302|Behavioral|Treatment Focusing on Improving Sentence Processing|Treatment will be administered from week 0 until week 12.
16130986|NCT01927302|Behavioral|No Treatment|No treatment will be administered.
16130987|NCT01927289|Procedure|Proximal Brachial Plexus vs Distal Forearm Block|"Proximal Brachial plexus block: 15 mls saline injected in distal forearm nerve block and 15 mls of 1.5% Mepivacaine injected to the brachial plexus via the supraclavicular approach.
~Distal forearm block: 15 mls 1.5% Mepivacaine injected in distal forearm nerve block and 15 mls of saline injected to the brachial plexus via the supraclavicular approach"
16130988|NCT01927276|Other|Gluten Free Flour|
16130989|NCT01927276|Other|Wheat Flour|
16130990|NCT01927263|Biological|NI-071|100mg/vial
16130991|NCT01927263|Biological|Infliximab|100mg/vial
16130992|NCT01927250|Behavioral|Okada Health and Wellness program|Each participant were encouraged to practice the diet program and art therapy established by the MOA International Corporation, and to receive Okada Purifying Therapy, a domain of biofield therapy, for 3 consecutive months.
16130993|NCT01927237|Other|HLR|
16130994|NCT01927237|Other|EHR|
16130995|NCT01927224|Drug|Nifurtimox (BAYa2502) (4 x 30 mg tablet)|120 mg single dose as four 30 mg tablets after a high fat, high calorie meal
16130996|NCT01927224|Drug|Nifurtimox (BAYa2502) (slurry of 4 x 30 mg tablets in tap water)|120 mg single dose as aqueous slurry in tap water produced from four 30 mg tablets; ingestion after a high fat, high calorie meal
16130997|NCT01927224|Drug|Nifurtimox (BAYa2502) (120 mg tablet)|120 mg single dose as one 120 mg tablet after a high fat, high calorie meal
16130998|NCT01927198|Drug|Placebo|
16130999|NCT01927198|Drug|RDEA3170 5 mg|
16131000|NCT01927198|Drug|RDEA3170 10 mg|
16131001|NCT01927198|Drug|RDEA3170 12.5 mg|
16131002|NCT01927185|Device|Long Axis strategy|With the long-axis approach the vein appeared in the longitudinal view. With this approach only the vein was visible on the screen. The needle was held at a 30° angle, oriented in-plane with the transducer and the skin punctured at the base of the transducer. The vessel alignment was maintained during the procedure and the entire length of the needle was visible during the progression through the tissues.
16131003|NCT01927185|Device|Short Axis Strategy|With the short-axis approach the probe was positioned almost perpendicularly to the clavicle. The needle was held at an angle of 45° relative to the skin surface and sagittal to the plane of the probe (out-of-plane). During the progression to the vessel, the visualization of the needle was limited to the deformation of tissue and artefacts produced by needle advancement. When the tip abutted the vein wall, additional pressure produced transient vessel deformation, which disappeared once the wall was penetrated.
16131004|NCT01927172|Device|AirSonea|
16131005|NCT01927159|Biological|ID93 + GLA-SE|
16131006|NCT01927159|Other|Placebo|
16131007|NCT01927120|Drug|IL-2|A subcutaneous injection will be administered 3 times a week (separated by at least 1 day between injections), from day 0 to +90 (+/- 7 days).
16131008|NCT01927120|Drug|Tacrolimus|Will be administered at 0.01 mg/kg/day (based on ideal body weight) continuous IV infusion or equivalent oral dosing starting on day -3
16131009|NCT01927120|Drug|Sirolimus|Orally on day -1. The dose for loading is 12 mg by mouth (PO)
16131010|NCT01927107|Dietary Supplement|Probiotics mixture|Comparison of probiotic mixture in addition to standard diet therapy vs. standart diet therapy
16131011|NCT01927094|Dietary Supplement|Probiotic|Comparison of probiotics vs. ORS
16131012|NCT01927094|Dietary Supplement|ORS|ORS ad libitum
16131013|NCT01927081|Behavioral|discussion group|Participants engage in discussions regarding issues related to coping with advanced cancer and pain
16131014|NCT01927081|Behavioral|gentle exercise|Patients learn gentle exercise and breathing techniques
16131015|NCT01927068|Device|CVI Paclitaxel-Coated PTA Balloon Catheter|Percutaneous Transluminal Angioplasty will be completed using a 2.0 micrograms per square millimeter. Paclitaxel-Coated Balloon. Balloon will be inflated to a size appropriate for the target vessel, as determined by the physician. Total balloon inflation time is determined by the physician, but no less than one minute.
16131016|NCT01927055|Drug|Droxidopa|Droxidopa at 100 mg, 200 mg, 300 mg
16131017|NCT01927055|Drug|Placebo|Placebo to match droxidopa capsules and strength designations
16131018|NCT01927042|Behavioral|ECHOs plus TAU|A self-help DVD that provides information for carers on eating disorders and teaches coping strategies to carers.
16131019|NCT01927042|Behavioral|Treatment as Usual|Treatment as Usual at the Eating Disorder Services includes group psychotherapy and skills training, nutritional counselling, and meal support.
16131020|NCT01927029|Drug|Progesterone|Vaginal progesterone gel 180mg/daily is given from second trimester (18 to 24 weeks) until 34 weeks.
16131021|NCT01927029|Drug|Placebo|
16131022|NCT01927016|Procedure|Esophagectomy|Esophagectomy for esophageal cancer whatever can be the surgical approach (with or without thoracotomy, minimally invasive or not)
16131023|NCT01927003|Procedure|Dorsal digito-metacarpal flap|The dorsal digito-metacarpal flap is a vascular island flap based on the dorsal digital artery and dorsal metacarpal artery. It has a longer vascular pedicle and provides tissue coverage of similar quality as that of normal glabrous skin but not sacrifice the digital artery.
16131024|NCT01926990|Device|perfusion computed tomography|Undergo perfusion CT
16131025|NCT01926977|Drug|Ranibizumab 0.5mg|Patient will receive intravitreal injection of Ranibizumab 0.5mg.
16131026|NCT01926977|Drug|Aflibercept 2.0mg|Patients will receive intravitreal injection of Aflibercept 2.0mg.
16131027|NCT01926951|Device|Surround Sound Externally Focused Therapeutic Ultrasound|Externally Focused Therapeutic Ultrasound using the Kona Surround Sound System
16131028|NCT01926912|Drug|No intervention|This is an observational study. Participants prescribed with paliperidone palmitate by the treating physician as per local labeling information in the hospital setting will be observed and data will be collected.
16131029|NCT01926899|Drug|Bortezomib administration|
16131030|NCT01926886|Drug|Trastuzumab|Trastuzumab 8 mg/kg (loading dose) and 6 mg/kg (maintenance dose) IV infusion q3w; Trastuzumab 600 mg q3w SC injection will be administered as per the schedule specified in the arm.
16131031|NCT01926860|Biological|Prevenar13|
16131035|NCT01926834|Drug|Erigeron Injection|Erigeron Injection, 30ml, iv, qd, for 7days
16131036|NCT01926834|Drug|placebo|normal saline, 500ml,i.v.,qd, for 7 days
16131037|NCT01926821|Drug|Sonifilan|Sonifilan inj 20mg Intra muscular injection, twice per week for 8 weeks, total 16 times
16131038|NCT01926795|Procedure|Short leg cast|
16131039|NCT01926795|Procedure|No Immobilization|
16131040|NCT01926782|Drug|Placebo (for alirocumab)|Solution for injection, subcutaneous injections in the abdomen, thigh, or outer area of upper arm with an auto-injector.
16131041|NCT01926782|Drug|Alirocumab|Solution for injection, subcutaneous injection in the abdomen, thigh, or outer area of upper arm with an auto-injector.
16131042|NCT01926782|Drug|Statin|Atorvastatin, rosuvastatin and simvastatin at stable dose in participants with stable statin therapy
16131043|NCT01926769|Drug|Metformin|
16131044|NCT01926756|Procedure|Straight catheterization|Patient will receive the current standard practice of straight catheterization intraoperatively.
16131045|NCT01926756|Procedure|No straight catheterization|Patients will not be catheterized which is an experimental change from the current practice at our hospital.
16131046|NCT01926743|Procedure|Near infrared fluorescence imaging during laparoscopic or robotic gastrectomy|0.75mg of ICG injection around tumor each four direction by endoscopy on one or two days before surgery. NIR fluorescence imaging application during laparoscopic or robotic gastrectomy
16131047|NCT01926730|Other|Restriction diet|Selected food items will be limited in the participants diet
16131048|NCT01926678|Other|Swedish massage therapy|
16131049|NCT01926678|Other|Light touch therapy|
16131050|NCT01926665|Drug|Carfilzomib|Starting dose: 20/20 mg/m2 by vein on Days 1, 2, 15, and 16 of each 28 day cycle.
16131051|NCT01926665|Drug|Dexamethasone|4 mg by vein or mouth prior to each Carfilzomib dose in Cycle 1 and 2 to prevent infusion reactions. After dexamethasone is stopped, it should be restarted and administered prior to subsequent doses for reactions.
16131052|NCT01926652|Drug|candesartan cilexetil 32mg, amlodipine 10mg|"Part A: Treatment A (candesartan), Treatment B (candesartan + amlodipine) 2-period, 2-treatment crossover.
~Part B: Treatment A (Amlodipine), Treatment B (candesartan + amlodipine) 2-period, 2-treatment crossover."
16131053|NCT01926639|Biological|Radiotherapy, rituximab and DC|Lymphoma lymph nodes are irradiated with 8 Gy single treatment and injected with rituximab (5 mg) and autologous DC intratumorally. The treatment is performed 3 times targeting different lymph nodes
16131054|NCT01926626|Drug|Nicotine Patch|"Pre-Quit Period: 2 weeks of patch use (21mg/24hr)
~Post Quit Period: 10 weeks of patch use (21mg/24hr for 6 weeks, 14mg/24hr for 2 weeks, and 7mg/24hr for 2 weeks)"
16131055|NCT01926626|Drug|Moclobemide|"Pre-Quit Period: 1 week of moclobemide use (400 mg/day in 2 divided doses)
~Post Quit Period: 10 weeks of moclobemide use (400 mg/day in 2 divided doses)"
16131056|NCT01926613|Behavioral|Thinking Skills for Work Program|The Thinking Skills for Work includes assessment of cognitive strengths and weaknesses and their relationship with work history, computerized cognitive practice, compensatory strategy training, and integration of cognitive and supported employment services.
16131057|NCT01926613|Behavioral|Supported Employment|Supported Employment is an evidence based vocational rehabilitation program
16131058|NCT01926587|Drug|oral rigosertib|Oral rigosertib will be administered twice a day in fasting conditions for weeks 1, 2, and 3 of a 4-week cycle.
16131059|NCT01926587|Drug|Azacitidine|Starting on Day 1 of second week (Day 8) of the cycle, azacitidine will be administered by subcutaneous injection or intravenous infusion at the labeled daily dose of 75 mg/m2, for 7 days.
16131060|NCT01926574|Behavioral|long rehabilitation program|
16131061|NCT01926574|Behavioral|short rehabilitation program|
16131062|NCT01926574|Behavioral|Acceptance and commitment therapy (ACT)|
16131063|NCT01926561|Other|Interscalene brachial plexus block|After sterile draping around interscalene groove with povidone, a nerve stimulating needle connected to a nerve stimulator is inserted through the interscalene groove. Following involuntary contraction of shoulder, arm, forearm, or hand muscles with 0.5 milliamperes at 1 Hz using the nerve stimulator, 30 to 40 ml of mixture of 1% mepivacaine 20 ml and 0.75% ropivacaine 20 ml are injected.
16131064|NCT01926548|Drug|CJ Imatinib mesylate tablet|
16131065|NCT01926548|Drug|Gleevec film-coated tablet 2 x 100mg|
16131066|NCT01926535|Procedure|Implant of amniotic membrane grafts|Amniotic membrane grafts were implanted in the affected eyes using topical anesthesia. Each graft was sutured to the bulbar conjunctive tissue using 10-0 nylon sutures and a reinforcement stitch was applied at the cornea
16131067|NCT01926535|Device|Therapeutic contact lenses|Therapeutic contact lenses were applied in all patients included in the control group and the lenses were replaced every two months according to the pre-established gold standard for this procedure.
16131068|NCT01926522|Device|Technological Rehabilitation|"The length of stride of reference used during the exercise is personalized and depends on the height of patients. Each patient carries out the feedback for 20 minutes with the aim of generating the most symmetric and regular gait.
~Patients, with the dynamometer, work on strengthening of flexor and extensor muscles with ankle speeds at 90°/sec and 120°/sec. The strengthening technique was performed twice for 10 minutes each time with a 1 minute rest between sets.
~The session ends with a 20-minute feedback on dynamic balance platform by carrying out exercises in which they need to reach randomly appearing targets. Subjects begin with 12 minutes the first 4 sessions, progress to 16 minutes the next 2 sessions, then 18' (2 sessions), and finally 20', if able, during the last 4 sessions."
16131069|NCT01926522|Other|Control Rehabilitation|When needed, more than on e therapist are employed in the intervention for safety reasons.
16131070|NCT01926509|Drug|MK-8892|
16131071|NCT01926509|Drug|Placebo for MK-8892|
16131072|NCT01926496|Drug|Ingenol Mebutate Gel, 0.015%|Ingenol mebutate gel 0.015 % (Picato®) applied on the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs.
16131073|NCT01926496|Drug|Imiquimod Cream, 5%|Imiquimod 5% cream applied to the selected treatment area. Retreatment if the treatment field is not completely cleared of AKs
16131074|NCT01926483|Other|Neoadjuvant Chemoradiotherapy|Surgery followed by cisplatin-based regimen and concurrent radiation (46Gy/23f), consolidate the original regimen 2 cycles.
16131177|NCT01925677|Device|da Vinci® Single-Site™|Planned single-incision laparoscopic nephrectomy performed with the assistance of the Da Vinci Robotic Surgical System.
16131075|NCT01926470|Procedure|anteroposterior approach group|anteroposterior approach group (n=104): check intravascular injection while performing S1 transforaminal epidural steroid injection in anteroposterior view under fluoroscopy
16131076|NCT01926470|Procedure|oblique approach group|oblique approach group (n=104): same as anteroposterior approach group except using oblique view
16131077|NCT01926457|Other|Treatment of Prediabetes|"Standardized treatment of prediabetes per California Diabetes and Pregnancy Program Sweet Success
~diabetes education
~blood glucose monitoring
~medications as needed per California Diabetes and Pregnancy established protocol
~growth ultrasounds
~antenatal testing"
16131078|NCT01926444|Drug|GIC-1001|GIC-1001 oral tablet, white-coated, to be taken with water
16131079|NCT01926431|Other|Exercise|
16131080|NCT01926431|Other|Rest|
16131081|NCT01926418|Behavioral|Planning tasks|"Implementation intentions: Participants are asked to specify when, where and how they plan to use condoms in the future.
~Executive function training aims to improve planning ability and therefore aims to increase condom use planning."
16131082|NCT01926405|Procedure|saliva collection|collection of saliva
16131083|NCT01926392|Drug|water-soluble therapy|The patient acted as their own control and the experimental and comparison arms (water-soluble therapy and silver sulfadiazine) were alternated on a daily basis
16131084|NCT01926392|Drug|silver sulfadiazine|The patient acted as their own control and the experimental and comparison arms (water-soluble therapy and silver sulfadiazine) were alternated on a daily basis
16131085|NCT01926379|Behavioral|Combination intervention components|"The CIP will contain programmatic, structural, and psychosocial components, including:
~use of a clinical algorithm by providers;
~identification of HIV-infected family members eligible for IPT, using an ICAP-developed family care enrollment form (ICAP - International Center for AIDS Care and Treatment Programs);
~review of monitoring data on IPT initiation and adherence during monthly multidisciplinary team meetings;
~reimbursement of transportation costs for monthly clinic visits; and
~real-time adherence support using IVR via mobile phones and trained Peer Educators."
16131086|NCT01926379|Drug|Isoniazid Prevention Therapy|Standard of care involves Isoniazid Prevention Therapy (IPT) - the administration of Isoniazid (INH) to individuals with latent infection with M. tuberculosis in order to prevent progression to active TB disease.
16131087|NCT01926366|Drug|AZD6423|Drug: AZD6423 Single or Multiple doses via infusion.
16131088|NCT01926366|Drug|Placebo|Placebo to match AZD6423 Single or Multiple doses of matching placebo delivered via infusion
16131089|NCT01926327|Biological|PRP injection|Injection of PRP in patients with knee osteoarthritis.
16131090|NCT01926327|Biological|Placebo|
16131091|NCT01926314|Device|PHENIX Neuromuscular Stimulation Therapy System device|
16131092|NCT01926314|Other|usual home care without device|
16131093|NCT01926301|Procedure|continuous veno-venous hemodialysis|
16131094|NCT01926288|Drug|Entecavir maleate tablets|
16131095|NCT01926288|Drug|blank Baraclude tablets|
16131096|NCT01926288|Drug|Blank maleate entecavir tablets|
16131097|NCT01926288|Drug|Baraclude tablets|
16131098|NCT01926275|Device|NPPV+IMT|noninvasive positive pressure ventilation and inspiratory muscle training
16131099|NCT01926275|Device|NPPV|noninvasive positive pressure ventilation
16131100|NCT01926275|Device|IMT|inspiratory muscle training
16131101|NCT01926262|Behavioral|Specific Strength Training|Specific Strength Training for the Neck and Shoulder Muscles
16131102|NCT01926236|Other|Active Symptom Control|Active Symptom Control: monthly clinical review and active symptom control as needed, including biliary drainage, antibiotics, analgesia, steroids, anti-emetics, other palliative treatment for symptom control, palliative radiotherapy, blood transfusion.
16131103|NCT01926236|Drug|L-folinic acid|L-folinic acid 175mg (or folinic acid 350mg) q14d, up to 12 cycles
16131104|NCT01926236|Drug|5 FU|5 FU 400 mg/m2 (bolus), 2400 mg/m2 (infusion), q 14d, up to 12 cycles
16131105|NCT01926236|Drug|Oxaliplatin|Oxaliplatin 85mg/m2, q 14d, up to 12 cycles
16131106|NCT01926223|Other|Home visiting|
16131107|NCT01926210|Other|mild stimulation protocol|letrozole is used from cycle day 3 to 7 and low dose recombinant FSH(no more than 150 IU/d) is used on cycle day 4,6 and 8 onwards. GnRH antagonist is only applied in case of premature LH rise might happen.
16131108|NCT01926210|Other|controlled ovarian stimulation|After fully downregulation by using short-acting GnRH agonist, 300 IU/d recombinant FSH is administrated for 5 days, then the dose is adjusted according to ovarian response.
16131109|NCT01926197|Drug|Oxaliplatin|
16131110|NCT01926197|Radiation|SBRT|
16131111|NCT01926197|Drug|Irinotecan|
16131112|NCT01926197|Drug|Leucovorin|
16131113|NCT01926197|Drug|5FU|
16131114|NCT01926184|Behavioral|Affect Regulation Treatment to Enhance Meth Intervention Success (ARTEMIS)|5-session integrative intervention to improve positive affect as well as boost and extend the effectiveness of contingency management (CM).
16131115|NCT01926184|Behavioral|Contingency Management (CM)|12-week CM protocol that provides escalating monetary reinforcement for biological evidence of methamphetamine abstinence. Delivered as the standard of care for non-treatment-seeking methamphetamine-using MSM in San Francisco. Delivered to both the intervention and attention-control arms
16131116|NCT01926171|Drug|Icotinib plus WBRT|Standard whole brain radiotherapy is given with 4000cGY/20 times, plus icotinib, which was administered orally three times per day.
16131117|NCT01926158|Drug|Denosumb|Prefilled syringe of 1 mL denosumab solution
16131118|NCT01926158|Drug|Placebo (for denosumab)|
16131119|NCT01926132|Drug|ascorbic acid 10g/20ml|ascorbic acid 10g/20cc intravenous injection for 40mins
16131120|NCT01926132|Drug|Normal Saline 150ml|Normal Saline 150ml intravenous injection for 40mins
16131121|NCT01926119|Device|Transcranial Magnetic Stimulation|
16131122|NCT01926106|Device|nIPPV|one of the twins was randomly allocated to nIPPV
16131123|NCT01926106|Device|nCPAP|another of the twins was allocated to nCPAP
16131174|NCT01925703|Drug|Sodium ferric gluconate|Sodium ferric gluconate 250 mg administered intravenously every 12 hours until iron repletion completed (as determined by Ganzoni equation) or patient discharge, whichever comes first.
16131175|NCT01925690|Behavioral|Motivational Interviewing-Cognitive Behavioral Therapy|A telephone based talk therapy discussing pros and cons of medication use in MS.
16131124|NCT01926080|Other|DVD Intervention Arm|Half of the parents will be prospectively randomized to receive the educational bereavement DVD entitled 'Grieving in the NICU- Mending Broken Hearts When a Baby Dies Too Soon'. A specific aim of the study is to evaluate the additional benefit of the Bereavement DVD over standard bereavement care in reducing parents' grief by comparing level of grief at each time point between the intervention (DVD) and control (no DVD) group.
16131125|NCT01926054|Drug|Acthar gel|
16131126|NCT01926041|Drug|Varenicline for tobacco smoking cessation|The 16-week varenicline course conforms to real-practice government regulations in Taiwan.
16131127|NCT01926041|Behavioral|Individualized counseling about both smoking cessation and weight control techniques|The FIT2 program also offers behavior coaching in diet and physical activity to restrict post-cessation weight gain, which is not covered in conventional smoking cessation services.
16131128|NCT01926028|Biological|NDV-3A|0.5mL injection IM
16131129|NCT01926028|Biological|NDV-3|0.5mL injection IM
16131130|NCT01926028|Biological|Placebo|aluminum hydroxide and buffered saline
16131131|NCT01926015|Biological|RotaTeq™ (V260)|Live, oral, pentavalent vaccine containing 5 human-bovine reassortant rotavirus strains
16131132|NCT01926015|Biological|DTP-IPV|Diphtheria, tetanus, pertussis, inactivated polio vaccine used as part of the Japanese vaccination schedule
16131133|NCT01926002|Drug|Low-Dose MK-8351|Single administration of low-dose MK-8351.
16131134|NCT01926002|Drug|High-Dose MK-8351|High-Dose MK-8351 administered as a single inhaled dose.
16131135|NCT01926002|Drug|Placebo to MK-8351|Single-Dose Matching placebo to high-dose or low-dose MK-8351.
16131136|NCT01925989|Biological|LY2605541|Administered SQ
16131137|NCT01925989|Biological|Insulin Glargine|Administered SQ
16131138|NCT01925976|Behavioral|Individualized dietetic intervention-eating habits|The school-year (12 months) dietetic intervention consisted of anthropometric measurements, dietetic assessment, energy restriction tailor-made daily menus, and parental education every three weeks at each school site.
16131139|NCT01925950|Drug|orBec|
16131140|NCT01925950|Drug|Placebo|
16131141|NCT01925937|Drug|Atorvastatin|
16131142|NCT01925937|Drug|Coenzyme Q10|
16131143|NCT01925937|Drug|placebo for coenzyme Q10|
16131144|NCT01925924|Other|Resin-modified glass ionomer cement|This material contains fluoride
16131145|NCT01925924|Other|Composite resin|This material does not include fluoride
16131146|NCT01925911|Drug|IPI-145|25 mg BID Oral Capsule
16131147|NCT01925911|Drug|Midazolam|2 mg midazolam syrup
16131148|NCT01925898|Drug|Midazolam - active comparator|Oral midazolam - 0.7mg/kg single dose
16131149|NCT01925898|Drug|Experimental Arm: Ketamine|Oral Ketamine 5mg/kg Single dose
16131150|NCT01925885|Procedure|PVI Ablation|PVI ablation for atrial fibrillation specifically targets areas in the left atrium in the area just outside the pulmonary veins to eliminate triggers of atrial fibrillation.
16131151|NCT01925885|Procedure|FIRM Ablation|Ablation for atrial fibrillation specifically targets areas in the left or right atrium to eliminate areas that maintain atrial fibrillation without isolating the pulmonary veins
16131152|NCT01925859|Drug|EryDex (dexamethasone sodium phosphate encapsulated erythrocytes)|erythrocytes encapsulated with dexamethasone sodium phosphate (EryDex System)-corresponding to either 50 mg OR 125mg of experimental study drug
16131153|NCT01925833|Procedure|Both insertion and withdrawal|inspection and polypectomy during both insertion and withdrawal of colonoscopy
16131154|NCT01925833|Procedure|Only withdrawal|inspection and polypectomy during only withdrawal of colonoscopy
16131155|NCT01925820|Drug|Pegasys&Entecavir|180 mcg Peg-IFN alfa-2a (Pegasys) once a week for 48 weeks. Entecavir daily will also be administered concurrently for 48 weeks and then given as monotherapy for an additional 96 weeks.
16131156|NCT01925807|Behavioral|Group Intervention|The intervention will consist of 6 psycho-educational group sessions for caregivers and 6 psycho-educational group sessions for adolescents. Adolescent and caregiver sessions will be held separately and will focus on different issues. For adolescents, the group sessions will focus on coping strategies and emotional regulation. For caregivers, the group sessions will be focused on attachment, family environment, and validation.
16131157|NCT01925794|Device|COBRA PzF|
16131158|NCT01925781|Drug|Nicotine polacrilex|2 mg and 4 mg gum will be used according to the FDA approved product labelling
16131159|NCT01925781|Other|STAM 1100mAh CE4 eGo Clearomizer|
16131160|NCT01925768|Drug|Apremilast 30 mg|30mg of Apremilast will be orally administered twice daily for 104 weeks
16131161|NCT01925768|Drug|Placebo|Identically appearing Placebo tablets will be orally administered twice daily for up to 24 weeks
16131162|NCT01925755|Other|Rivaroxaban ( Xarelto, BAY59-7939)|Patients with prior stroke or TIA history and who have never taken anticoagulation treatment regarding AF before. One film-coated tablet contains Rivaroxaban 15 mg or 20mg
16131163|NCT01925742|Other|Integrated prenatal screening for Down's syndrome|Analysis of several serum biochemical markers, and fetal nuchal translucency by ultrasound, with computation of an individual risk of fetal aneuploidy.
16131164|NCT01925742|Other|Serum QUAD Assay for aneuploidy screening|Series of biochemical markers with results integrated into a computational estimate of risk of fetal aneuploidy
16131165|NCT01925742|Other|Semiconductor MPSS NIPT assay using ccfDNA in maternal blood|Analysis by next-generation sequencing of ccfDNA (circulating cell-free DNA) from maternal blood, using a targeted NIPT assay.
16131166|NCT01925742|Other|Optical-based MPSS NIPT assay using ccfDNA in maternal blood|Analysis by next-generation sequencing of ccfDNA (circulating cell-free DNA) from maternal blood, using an un-targeted NIPT assay.
16131167|NCT01925742|Other|Harmony™ Test (Ariosa Diagnostics)|Test that is commercially available (Ariosa Diagnostics). (will be used for benchmarking purposes in a subset of each arm)
16131168|NCT01925729|Biological|ragweed|ragweed arm only
16131169|NCT01925729|Biological|histamine|histamine arm only
16131170|NCT01925729|Drug|pseudoephedrine|pseudoephedrine arm only
16131171|NCT01925729|Drug|Oxymetazoline|oxymetazoline arm only
16131172|NCT01925716|Other|Corn oil|corn oil 56 g/day for 21 days
16131173|NCT01925716|Other|Olive oil|olive oil 56 g /day for 21 days
16131176|NCT01925690|Behavioral|Brief Education|Give patients a pamphlet discussing pros and cons of disease modifying therapies
16131178|NCT01925664|Behavioral|Doula|This intervention included doulas providing weekly home visits during the last trimester of pregnancy and up to three months postpartum. Home visits focused on prenatal health, preparation for childbirth, breastfeeding education, and developing a relationship with the baby. Doulas also were present in the hospital during labor, delivery, and postpartum providing emotional support, non-medical comfort measures, and breastfeeding counseling.
16131179|NCT01925651|Radiation|No Bolus|no bolus use
16131180|NCT01925651|Radiation|Alternate Bolus|0.5cm bolus use in alternate days
16131181|NCT01925651|Radiation|Continuous Bolus|0.5 cm bolus use in continuous days
16131182|NCT01925638|Drug|BAY86-9766|
16131183|NCT01925638|Drug|Ketoconazole|
16131184|NCT01925625|Biological|Early CDT Lung blood test|The EarlyCDT-Lung Test is an early detection test designed to assist in lung cancer risk assessment and detection in the earliest stages of the disease.
16131185|NCT01925612|Drug|brentuximab vedotin|1.2 mg/kg by IV infusion every 3 weeks for up to 6 cycles
16131186|NCT01925612|Drug|brentuximab vedotin|1.8 mg/kg by IV infusion every 3 weeks for up to 6 cycles
16131187|NCT01925612|Drug|rituximab|375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
16131188|NCT01925612|Drug|vincristine|1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)
16131189|NCT01925612|Drug|cyclophosphamide|750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
16131190|NCT01925612|Drug|prednisone|100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles
16131191|NCT01925612|Drug|doxorubicin|50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles
16131192|NCT01925573|Device|Optune(NOVOTTF-100A)|
16131193|NCT01925560|Other|Agave Inulin|3x3 Latin square with 3 periods
16131194|NCT01925560|Other|Placebo|control- 0 (zero) grams/day inulin
16131195|NCT01925547|Dietary Supplement|Micellar curcumin|80 mg micellar curcumin (oral) three times a day for six weeks
16131196|NCT01925547|Dietary Supplement|Placebo|Only the excipients (without curcumin) used to prepare the curcumin micelles are given as placebo.
16131197|NCT01925534|Device|High-flow humidified nasal oxygen delivery system|During breaks from NIV oxygen will be provided through the Optiflow with FiO2 and flow-rate titrated to maintain the oxygen saturation (SpO2) above 90%.
16131198|NCT01925534|Device|Standard oxygen therapy|During breaks from NIV oxygen will be provided by standard nasal cannula or mask to maintain the SpO2 above 90%.
16131199|NCT01925521|Drug|Part1 : OPS-2071|single oral dose under fasted condition
16131200|NCT01925521|Drug|Part1 : Placebo of OPS-2071|single oral dose under fasted condition
16131201|NCT01925521|Drug|Part2 : OPS-2071|multiple twice-daily oral dosing for 5-7days
16131202|NCT01925521|Drug|Part2 : Placebo of OPS-2071|multiple twice-daily oral dosing for 5-7days
16131203|NCT01925495|Other|varied middle-ear pressure|
16131204|NCT01925495|Drug|varied middle-ear gas composition|
16131205|NCT01925495|Other|varied ear-canal pressure|
16131206|NCT01925482|Drug|6%CO2, 25%O2, balance N2|exposure of middle ear to gas
16131207|NCT01925482|Drug|6% CO2, 0%O2, balance N2|exposure of middle ear to gas
16131208|NCT01925482|Drug|20%CO2, 6%O2, balance N2|exposure of middle ear to gas
16131209|NCT01925482|Drug|0%CO2, 6%O2, balance N2|exposure of middle ear to gas
16131210|NCT01925482|Drug|6% CO2, 6%O2, balance N2|exposure of middle ear to gas
16131211|NCT01925482|Drug|6%CO2, 6%O2, 0%N2, balance argon|exposure of middle ear to gas
16131212|NCT01925469|Drug|Benzocaine|
16131213|NCT01925469|Drug|Saline spray|A saline spray will be used in the placebo group
16131214|NCT01925456|Drug|Toviaz|Means of effectiveness, adherence, and utility instruments over time will be examined to evaluate whether changes are linear from baseline to 8 weeks and 3 months. We will demonstrate the validity and responsiveness of pragmatic instruments against existing established measures (Table 3).
16131215|NCT01925443|Other|Low level laser therapy|Will be performed irradiation with low-intensity laser in quadriceps muscle
16131216|NCT01925430|Device|Screening device|Non-invasive device worn over clothes during sleep. Used to screen for sleep-disordered breathing conditions.
16131217|NCT01925430|Device|Comparative product|A non-invasive device worn on the arm or leg. It monitors body movement and sleep/wake states
16131218|NCT01925417|Biological|RBX2660 (microbiota suspension)|
16131219|NCT01925404|Behavioral|Free physical activity classes|100 hours of free activity classes will be provided
16131220|NCT01925404|Behavioral|Frequent User|Participants can become eligible for prizes by visiting the park more frequently
16131221|NCT01925391|Drug|Tono-pen XL Applanation tonometer + Ocu-film +|
16131222|NCT01925378|Drug|Nelfinavir|"All medications which a patient is taking will be reviewed at each visit, including the screening, day 1, weeks 4,12, 24.
~All patients enrolled in the study will receive 1,250 mg twice PO daily for a 24 week duration."
16131223|NCT01925365|Dietary Supplement|wholegrain cereals oats (WGO)|Volunteers had to consume wholegrain cereals oats (WGO)(45g/day) for six weeks followed by a four week wash out period
16131224|NCT01925365|Dietary Supplement|Non wholegrain cereals|Volunteers had to consume non wholegrain cereals (NWG)(45g/day) for six weeks followed by a four week wash out period.
16131225|NCT01925352|Drug|Ad-HGF|5×10(9)pfu adenovirus hepatocyte growth factor was delivered by transendocardial injection into five left ventricular sites.
16131226|NCT01925339|Device|Test (immediate restoration)|Test (immediate restoration)
16131227|NCT01925339|Device|Control: delayed restoration|Control: delayed restoration
16131228|NCT01925313|Drug|CJ-30044|20.51mg a day,PO,QD
16131229|NCT01925313|Drug|TALION TAB. 10mg|10mg a day,PO,BID
16131230|NCT01925300|Drug|Concor 5mg(Bisoprolol hemifumarate 5mg) 2Tab|
16131231|NCT01925300|Drug|Crestor 20mg(Rosuvastatin calcium 20.80mg) 1Tab|
16131232|NCT01925300|Drug|Concor 5mg 2T and Crestor 20 mg 1Tab|
16131233|NCT01925287|Dietary Supplement|curcumin|500 mg curcumin were given orally either as native powder, micronized powder, or liquid micelles
16131234|NCT01925274|Drug|PF-05212384|30 minute IV infusion of PF-05212384 on days 2, 9, 16 and 23 of each cycle. Intra-patient dose escalation will commence with 110mg and will increase depending on tolerability.
16131322|NCT01924650|Drug|PH-797804|Tablet, 6 mg, single dose
16131235|NCT01925274|Drug|irinotecan|90 minutes IV infusion of irinotecan 180mg/m^2 on days 1 and 15 of each cycle
16131236|NCT01925274|Drug|Cetuximab|120 minute IV infusion of cetuximab 400mg/m^2 on cycle 1 day 1; 60 minute IV infusion of cetuximab on days 8, 15, and 22 of each cycle, and on day 1 of each cycle after cycle 1
16131237|NCT01925274|Drug|Irinotecan|90 minutes IV infusion of Irinotecan 180mg/m^2 on days 1 and 15 of each cycle
16131238|NCT01925261|Drug|TPX-100 50mg|
16131239|NCT01925261|Drug|TPX-100 100mg|
16131240|NCT01925261|Drug|TPX-100 200mg|
16131241|NCT01925261|Drug|TPX-100 20mg|
16131242|NCT01925261|Drug|Placebo|
16131243|NCT01925248|Dietary Supplement|Whey protein|Whey protein group participants will take supplement drinks that contain whey protein, daily before breakfast and before dinner for 3 months.
16131244|NCT01925248|Dietary Supplement|Placebo group|Placebo group participants will take supplement drinks that do not contain whey protein, daily before breakfast and before dinner for 3 months.
16131245|NCT01925235|Procedure|remote ischemic preconditioning|
16131246|NCT01925209|Drug|BYM338/bimagrumab|BYM338, a 150 mg/mL concentrate for solution for i.v. infusion, was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps.
16131247|NCT01925209|Drug|Placebo|Matching placebo to BYM338 was provided in colorless glass vials with a rubber stopper and aluminum flip-off caps.
16131248|NCT01925183|Drug|Pegylated interferon alpha-2a|180mcg once weekly; subcutaneous injection
16131249|NCT01925183|Drug|Ribavirin|600mg two times daily (BID) (e.g. 3x200mg at 6am, 3x200mg at 6pm) in patients ≥75kg body weight; 2x200mg at 6am and 3x200mg at 6pm in patients <75kg; orally
16131250|NCT01925183|Drug|Boceprevir|800mg three times daily (TID) (e.g. 4x200mg at 6am, 4x200mg at 2pm, 4x200mg at 10pm); orally
16131251|NCT01925170|Device|Molecular Breast Imaging|Molecular breast imaging is a new nuclear medicine technique for imaging the breast. It uses small field of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.
16131252|NCT01925170|Device|Conventional Mammography|Mammography is the process of using low-energy X-rays (usually around 30 kVp) to examine the human breast and is used as a diagnostic and a screening tool.
16131253|NCT01925170|Drug|Technetium (99mTc) sestamibi|Technetium (99mTc) sestamibi is a pharmaceutical agent used in nuclear medicine imaging. The drug is a coordination complex consisting of the radioisotope technetium-99m bound to six methoxyisobutylisonitrile (MIBI) ligands.
16131254|NCT01925157|Biological|LY3090106 - SQ|Administered SQ.
16131255|NCT01925157|Biological|LY3090106 - IV|Administered IV.
16131256|NCT01925157|Biological|Placebo - SQ|Administered SQ.
16131257|NCT01925144|Drug|Baricitinib|Administered orally
16131258|NCT01925144|Drug|Omeprazole|Administered orally
16131259|NCT01925131|Drug|cyclophosphamide|Given IV
16131260|NCT01925131|Drug|vincristine sulfate|Given IV
16131261|NCT01925131|Drug|prednisone|Given PO
16131262|NCT01925131|Biological|inotuzumab ozogamicin|Given IV
16131263|NCT01925131|Other|laboratory biomarker analysis|Correlative studies
16131264|NCT01925118|Biological|Irradiated donor lymphocyte infusion|
16131265|NCT01925105|Other|Experimental: Optimization of treatment|Optimization of treatment of diseases and symptoms
16131266|NCT01925092|Drug|mifepristone|tablets
16131267|NCT01925079|Behavioral|Intensive Education|"Statin Treatment：The investigator will be suggested to increase the dose of atorvastatin according to guideline if a patient's LDL-C does not achieve target level.
~Patient education:
~Routine education at discharge.
~4 education brochures will be delivered to patients.
~Calendar with healthy tips will be delivered to patients before discharge.
~A follow-up brochure with medical expert letter.
~A total of 24 specific short messages for ACS will be developed and sent to patients (one short message per week).
~Telephone follow ups will be performed according to a standard communication document.
~At discharge, patients will be given a brochure for future follow up."
16131268|NCT01925079|Other|Control|"Statin Treatment：The recommended dosage of atorvastatin will be adjusted at the physician's discretion.
~Patient education:
~Routine education at discharge.
~A follow-up brochure without medical expert letter.
~At discharge, patients will be given a brochure for future follow up."
16131269|NCT01925066|Drug|Vancomycin|
16131270|NCT01925053|Other|PAL meal|The effect of consuming the PAL meal on gastric retention will be assessed
16131271|NCT01925053|Other|REF meal|The effect of consuming the REF meal on gastric retention will be assessed
16131272|NCT01925040|Device|Placement of restoration|Placement of restorations
16131273|NCT01925027|Device|Nano+ DES|All patients will be treated with the NanoTM Polymer-free Sirolimus Coronary Stent System. All patients will undergo angiographic (QCA) investigation at baseline (pre- and post-procedure) and at 3 months follow-up. All patients will undergo OCT investigation at 3 months follow-up. All patients will be evaluated clinically at 3, 4, 5 months (for patients with 6 months OCT follow-up evaluation will be at 8 months) and at 1 and 2 years.
16131274|NCT01925014|Diagnostic Test|Diagnostic CT with low-dose radiation|Effective dose is aimed at approximately 2 millisievert (mSv) in an average patient.
16131275|NCT01925014|Diagnostic Test|Diagnostic CT with standard-dose radiation|Effective dose is aimed at approximately 8 millisievert (or less) in an average patient.
16131276|NCT01925001|Drug|MP4CO|43 mg/mL pegylated carboxyhemoglobin [≥ 90% CO hemoglobin saturation] in physiological acetate electrolyte solution
16131277|NCT01925001|Drug|Sodium chloride solution|Normal saline solution (0.9% Sodium Chloride Injection USP)
16131278|NCT01924988|Device|Prostatic Embolization with Embosphere Micropsheres|"Each patient will have a selective internal iliac arteriogram, and as necessary, an arteriogram of the anterior division of the internal iliac artery performed to identify the prostatic arterial supply. This typically arises from the inferior vesicle artery (also known as the prostatic artery), but may have supply from the superior vesicle, the internal pudendal or obturator branches as well.
~The prostatic arteries will be selected using standard micro-catheter technique. Embolization of the prostate will be performed with 300 to 500 um sized TAGM (Embosphere® Microspheres, Merit Medical, South Jordan, UT). The embolization endpoint will be absence of the normal blush of the prostate on post embolization angiography and stasis of flow in the prostate arteries."
16131323|NCT01924650|Drug|PH-797804|Tablet, 6 mg, single dose
16131279|NCT01924975|Procedure|Saphenous vein cannulation|Intravenous cannulation to saphenous vein
16131280|NCT01924975|Device|ultrasound with a linear transducer (L15-7io)|Portable, bed-side ultrasound to detect saphenous vein
16131281|NCT01924975|Device|A 22 or 24 G intravenous catheter|
16131282|NCT01924962|Device|revascularisation|revascularisation of chronic occluded coronary artery
16131283|NCT01924949|Drug|LDV/SOF|Ledipasvir (LDV)/sofosbuvir (SOF) 90/400 mg FDC tablet administered orally once daily
16131284|NCT01924936|Behavioral|DBT Online Program|DBT online program involving three DBT skills taught across three lessons. The DBT online program will be based on a brief DBT skills intervention previously developed and pilot tested by Dr. Whiteside. This DBT online program will provide far greater clinical intensity than Intervention 1 and will be delivered with a widely-used modular software platform suitable for an R-34 project.
16131285|NCT01924910|Dietary Supplement|250,000 IU cholecalciferol as single, oral dose|250,000 IU cholecalciferol (vitamin D3) provided as a single oral dose.
16131286|NCT01924910|Dietary Supplement|Placebo|
16131287|NCT01924897|Behavioral|Exercise training|
16131288|NCT01924871|Drug|Desflurane with remifentanil|During the emergence from anesthesia,extubation was performed under 1.0 MAC desflurane with 1.0ng/ml remifentanil
16131289|NCT01924871|Drug|Desflurane|During the emergence from anesthesia,extubation was performed under 1.5 MAC desflurane
16131290|NCT01924858|Drug|GSK2647544 oral|GSK2647544 100 mg will be supplied as a size 0 swedish orange hard gelatin capsules filled with white/slightly colored granule. Subjects will receive a single oral dose of GSK2647544 100 mg (2 X 50mg capsules) with 150 mL of tepid water approximately 2 hours prior to the IV infusion of [18F]-GSK2647544 and a PET scan.
16131291|NCT01924858|Drug|[18F]GSK2647544 IV bolus|[18F]GSK2647544 will be supplied as a clear, colourless solution free from visible particle. A maximum dose up to 2 mg with a maximum dose volume of 25 mL will be administered as IV bolus over 60 seconds.
16131292|NCT01924845|Drug|BMN 701|BMN 701 20 mg/kg for intravenous administration over approximately 4 hours every 2 weeks over a 24-week Treatment Period (total of 13 doses), and every 2 weeks over a 240-week Extension Period (up to 120 additional doses).
16131293|NCT01924832|Drug|dimethyl fumarate|tablet
16131294|NCT01924819|Drug|Epirubicin + cisplatin + 5-fluorouracil OR epirubicin + cisplatin + capecitabine OR epirubicin + oxaliplatin + capecitabine OR 5-Fluorouracil + leucovorin + oxaliplatin + docetaxel|"Epirubicin 50 mg/m2 IV day 1, cisplatin 60 mg/m2 IV day 1, 5-fluorouracil 200 mg/m2/d IV 21 day continuous infusion (ECF chemotherapy).
~Epirubicin 50 mg/m2 IV day 1, Cisplatin 60 mg/m2 IV day 1, Capecitabine (X = Xeloda) 625mg/m2, bid days 1-21 (ECX chemotherapy)
~Epirubicin 50mg/m2 IV day 1, Oxaliplatin (O) 130mg/m2 IV day 1, Capecitabine 625mg/m2, bid days 1-21 (EOX chemotherapy)
~5-Fluorouracil 2600 mg/m² IV 24 h infusion day 1, Leucovorin (L) 200 mg/m² IV day 1, Oxaliplatin 85 mg/m² IV day 1, Docetaxel (T) 50 mg/m² IV day 1 (FLOT chemotherapy)"
16131295|NCT01924819|Radiation|Preoperative chemoradiotherapy|"Chemotherapy: Continuous infusional 5-fluorouracil 200mg/m2/day, 7 days per week, throughout the entire period of radiotherapy or capecitabine 825 mg/m2, oral tablet twice daily, days 1-5 of each week of radiotherapy (without weekends).
~Radiotherapy: 45 Gy of radiation in 25 fractions, five days per week for five weeks."
16131296|NCT01924819|Procedure|Gastric resection|The acceptable resections are a total gastrectomy, a subtotal gastrectomy, and an esophagogastrectomy (Ivor-Lewis esophagogastrectomy for gastroesophageal junction cancers [Siewert Type II and Siewert Type III] invading up to but no more than 2cm of the lower esophagus). The minimum extent of the operation should be a D1+ lymph node dissection but it is recommended that a D2 dissection be performed or a D1+ for gastroesophageal junction cancers requiring an esophagogastrectomy.
16131297|NCT01924806|Device|WoundWand™ Debridement Device|Group I - Electrical energy that removes necrotic, ischemic, and/or infected tissue within a wound
16131298|NCT01924806|Device|Standard of Care sharp debridement|Group II - Sharp instruments that remove necrotic, ischemic, and/or infected tissue within a wound
16131299|NCT01924793|Drug|DAS181-F02 Dry Powder in Bulk|Administered via DPI
16131300|NCT01924793|Drug|DAS181-F02 Nebulized Formulation Inhaled Dose|Administered via Nebulizer
16131301|NCT01924780|Device|Stimulation 10 minutes|NEMOS transvagal stimuli 10 minutes
16131302|NCT01924780|Device|NEMOS transvagal stimulation 60 minutes|NEMOS Device stimulation in 60 minutes
16131303|NCT01924780|Device|NEMOS Device sham stimulation 10 minutes|
16131304|NCT01924767|Drug|BI 10773 Placebo|po taken fasting with 240 mL water
16131305|NCT01924767|Drug|BI 10773|po taken fasting with 240 mL water
16131306|NCT01924767|Drug|BI 10773 Placebo|po taken fasting with 240 mL water
16131307|NCT01924767|Drug|BI 10773|po taken fasting with 240 mL water
16131308|NCT01924767|Drug|BI 10773 Placebo|po taken fasting with 240 mL water
16131309|NCT01924767|Drug|BI 10773 Placebo|po taken fasting with 240 mL water
16131310|NCT01924767|Drug|BI 10773|po taken fasting with 240 mL water
16131311|NCT01924767|Drug|BI 10773|po taken fasting with 240 mL water
16131312|NCT01924741|Procedure|ALPPS|Other procedures related to ALPPS like banding of the parechyma with portal vein ligation etc.
16131313|NCT01924728|Device|Magnetic stimulation|50Hz active magnetic stimulation (coil position 100%) delivered to the pelvic floor muscles
16131314|NCT01924728|Device|Sham magnetic stimulation|50Hz sham magnetic stimulation (coil position 0%) delivered to the pelvic floor muscles
16131315|NCT01924715|Behavioral|ISTDP|An emotion focused brief psychotherapy format.
16131316|NCT01924702|Behavioral|Intensive language therapy|2 weeks of daily computerized naming training, daily, 3 hours
16131317|NCT01924702|Device|transcranial direct current stimulation|1mA anodal over M1 primary motor cortex for 20min with 35cm/2 electrode, Cathode (100cm/2) contralateral
16131318|NCT01924689|Biological|Clostridium novyi-NT spores|Phase 1 study: It will be an escalating dose design, with no intracohort escalation. The first cohort dose will begin at 1 x 10(4) spores/kg and will escalate by tripling through 5 cohorts up to 100 x 10(4) spores/kg.
16131319|NCT01924676|Drug|Oxycodone|One capsule of 40 mg PF-00345439 Formulation X, single dose, under fasting conditions
16131320|NCT01924676|Drug|Oxycodone|One capsule of 40 mg PF-00345439 Formulation K, single dose, under fasting conditions
16131321|NCT01924676|Drug|Oxycodone|One capsule of 40 mg PF-00345439 Formulation K, single dose, under fed conditions
16131326|NCT01924650|Drug|PH-797804|Tablet, 6 mg, single dose
16131327|NCT01924650|Drug|PH-797804|Tablet, 6 mg, single dose
16131328|NCT01924637|Drug|Faster-acting insulin aspart|"A single dose will be administered subcutaneously (under the skin) in the abdomen.
~Each subject will be allocated to two treatment periods separated by a wash-out period of 3-12 days."
16131329|NCT01924637|Drug|insulin aspart|"A single dose will be administered subcutaneously (under the skin)) in the abdomen.
~Each subject will be allocated to two treatment periods separated by a wash-out period of 3-12 days."
16131330|NCT01924624|Drug|Thalidomide|Patients in the Adjuvant group were given oral Thalidomide(at a dose of 100 mg per day) continuously during the follow-up period
16131331|NCT01924611|Procedure|Atraumatic Restorative Technique using cotton rolls|Atraumatic Restorative Technique using cotton rolls.
16131332|NCT01924611|Procedure|Atraumatic Restorative Technique|"Atraumatic Restorative Technique is typically used in Minimally invasive Dentistry.
~This restoration technique is made using only hand instruments and is possible to be carried out in children in schools.
~This particular time, the isolation of the surgical/tooth area was made using rubber dam as saliva barrier."
16131333|NCT01924598|Device|DBS to nucleus accumbens/anterior limb of internal capsule|deep brain stimulation followed by 12 month post switch on followup
16131334|NCT01924572|Procedure|cord clamping at 2 minutes|
16131335|NCT01924572|Procedure|cord clamping at 5 minutes|
16131336|NCT01924572|Procedure|cord milking|
16131337|NCT01924559|Other|standard clothing|
16131338|NCT01924559|Other|Biohazard gear|
16131339|NCT01924559|Device|Direct Laryngoscopy|
16131340|NCT01924559|Device|Glidescope|
16131341|NCT01924559|Device|Supraglottic Airway|
16131342|NCT01924546|Other|Water|1.5 L bottle of water provided in the morning of the school day, with refills provided during the course of the day.
16131343|NCT01924533|Drug|Olaparib|Tablets-at a dose of 100mg orally twice daily, throughout each cycle (28 days); Once paclitaxel dosing is stopped, the planned monotherapy olaparib dose will be 300mg twice daily.
16131344|NCT01924533|Drug|Paclitaxel|IV infusion over 1 hour at 80 mg/m2 weekly on days 1, 8 and 15 of a 28 days schedule.
16131345|NCT01924533|Drug|Placebo|Tablets-at a dose of 100mg orally twice daily, throughout each cycle (28 days); Once paclitaxel dosing is stopped, the planned monotherapy placebo dose will be 300mg twice daily.
16131346|NCT01924520|Drug|FK949E|Oral
16131347|NCT01924507|Device|CPAP|CPAP - continuous positive air pressure in patients with sleep apnea
16131348|NCT01924481|Dietary Supplement|High Caffeine|
16131349|NCT01924481|Dietary Supplement|Low caffeine|
16131350|NCT01924481|Dietary Supplement|High theobromine|
16131351|NCT01924481|Dietary Supplement|low theobromine|
16131352|NCT01924481|Dietary Supplement|No theobromine|
16131353|NCT01924468|Drug|Oral methylphenidate and Oral haloperidol|
16131354|NCT01924429|Drug|Lisdexamfetamine|Escalating stepped dose titration: 30, 50 or 70mg
16131355|NCT01924416|Behavioral|Enhanced Care (intervention group and comparison group)|Decision aid coupled with immediate QL-PRO results
16131356|NCT01924416|Behavioral|Usual care (routine chemotherapy cycles and imaging studies)|Usual care does not receive intervention
16131357|NCT01924403|Procedure|Staple Closure|
16131358|NCT01924403|Procedure|Vertical Mattress Closure|
16131359|NCT01924403|Procedure|Running Subcuticular Closure|
16131360|NCT01924390|Device|Mineralized freeze-dried bone allograft alone|
16131361|NCT01924390|Device|Combination of Mineralized and demineralized freeze-dried bone allograft alone|
16131362|NCT01924377|Procedure|standard circumferential pulmonary vein isolation by radiofrequency ablation catheter|To perform circumferential pulmonary vein isolation left and right circumferential lines will be created with contiguous focal radiofrequency lesions at a distance >5 mm from the pulmonary vein ostia. Two additional ablation lines will be performed in the posterior left atrium (LA), and an ablation line will be placed in the mitral isthmus to prevent postablation LA flutter. Patients with a history of typical atrial flutter will also undergo cavotricuspid isthmus ablation.
16131363|NCT01924377|Procedure|CPVI + rotors' identification and ablation|In CPVI + Rotor arm, two LA sequential maps will be collected before and after CPVI, respectively. During each map creation, rotor electrograms will be identified by the physician. Rotors will be ablated after collecting the second LA sequential map.
16131364|NCT01924364|Device|Tissue Genesis Cell Isolation System™ (TGI CIS)|In this study, we will concentrate the adipose stromal cells (ASCs) in the fat graft material to assess whether this modification will increase fat graft retention over time. The concentrated fat to be injected into the subject from the fat grafting procedure will be processed by the Tissue Genesis Cell Isolation System™ (CIS) device. The volume retention in areas treated with ASC concentrated fat grafts will be compared with regions treated with standard fat grafts in the same patient. Additionally, data from our current study assessing volume retention after fat grafting for facial deformities (IRB # PRO09060101, NCT01345591) will be used for comparison.
16131365|NCT01924364|Procedure|Standard of care fat grafting|In this study, we will concentrate the adipose stromal cells (ASCs) in the fat graft material to assess whether this modification will increase fat graft retention over time.
16131366|NCT01924351|Radiation|Stereotactic Radiosurgery plus HER-2 directed therapy in HER2-positive Breast Cancer with Brain Metastasis|
16131367|NCT01924338|Device|MRI scan|Acquisition of a high-resolution MRI scan (0.15 x 0.15 x 1.0 mm³) aligned with the AC-PC (anterior commissure-posterior commissure) line
16131368|NCT01924338|Device|Laser scan|A near-infrared laser scan of the subject's forehead is acquired
16131369|NCT01924338|Procedure|Dental cast creation|A dental cast made of PMMA (polymethyl methacrylate) of the subject's maxilla is created
16131370|NCT01924325|Drug|Apixaban|orally active direct factor Xa inhibitor
16131371|NCT01924325|Drug|Clopidogrel|an irreversible inhibitor of the P2Y12 adenosine diphosphate receptor
16131372|NCT01924325|Drug|Aspirin|a non-steroidal anti-inflammatory drug
16131373|NCT01924325|Drug|placebo|
16131446|NCT01923831|Drug|dexamethasone|Normal saline 100mL was infused for 10 minutes immediately before anesthesia induction. After tracheal intubation, dexamethasone 8mg was injected, and normal saline was continuously infused at the rate of 10 mg Kg-1 h-1 until the end of surgery. (at the time of skin closure)
16131374|NCT01924312|Behavioral|Heart Health Intervention|A specialty CVD Risk Clinic will focus on education and individualized treatment programs to modify vascular risks in each subject using the methods developed, tested and shown to successfully reduce multiple CVD risk factors in the HeartHealth Program (HRSA grant, 1D1ARH1606, phase I and 2).
16131375|NCT01924299|Drug|Baricitinib|Administered orally
16131376|NCT01924299|Drug|Ketoconazole|Administered orally
16131377|NCT01924299|Drug|Fluconazole|Administered orally
16131378|NCT01924286|Drug|Prednisone|
16131379|NCT01924286|Drug|Placebo|
16131380|NCT01924273|Drug|Talaporfin sodium|Combined Photodynamic/Pulsed Dye Laser Therapy/Talaporfin sodium
16131381|NCT01924260|Drug|alisertib|Given PO
16131382|NCT01924260|Drug|gemcitabine|Given IV
16131383|NCT01924247|Behavioral|Outpatient secondary prevention program|The comprehensive outpatient program is designed to last for 12 weeks. Participants are treated in groups of 8 or less. Every week there are two days with therapeutic and educational sessions, once with two hours of physical exercise therapy and once with 45 minutes of aerobic ergometer training and one hour of lecture and counseling. On the day with the two hours of physical therapy one of the sessions includes aerobic ergometer training or Nordic walking, and the other session focuses on improvements of fine motor skills, coordination, balance, mobilization, stretching, weight training or breathing. The lectures include three lectures on etiology, diagnosis, treatment and prevention of stroke by a neurologist, one on vascular risk factors by a cardiologist, five on nutrition counseling by nutritionists, two on active and passive smoking cessation and one lecture on psychological coping strategies given by a neuropsychologist.
16131384|NCT01924247|Behavioral|Standard treatment by family physician|Standard treatment by family physician.
16131385|NCT01924234|Drug|Morphine|
16131386|NCT01924234|Drug|Remifentanil|
16131387|NCT01924208|Biological|Timothy, Phleum pretense|Allergen. Grazax® sublingual 75.000 SQ-T tablet (extracted from timothy, Phleum pretense), once daily until operation (ALK-Abelló, Hørsholm, Denmark) (n=30) .
16131388|NCT01924208|Biological|Live attenuated influenza virus|Virus. Fluenz®, nasal live attenuated influenza vaccine, one 0.2 mL dose (MedImmune, Gaithersburg, USA) (n=60, 50:50 atopic:non-atopic).
16131389|NCT01924208|Procedure|Timothy + attenuated influenza virus|Allergen. Grazax® sublingual 75.000 SQ-T tablet (extracted from timothy, Phleum pretense), once daily until operation (ALK-Abelló, Hørsholm, Denmark) + Virus. Fluenz®, nasal live attenuated influenza vaccine, one 0.2 mL dose (MedImmune, Gaithersburg, USA) (n=30).
16131390|NCT01924195|Drug|Anlotinib|Anlotinib QD po.
16131391|NCT01924195|Drug|Placebo capsule|Placebo QD po.
16131392|NCT01924182|Device|SynchroMed Infusion System and Intrathecal Morphine Sulfate|Following a successful test of Intrathecal Morphine Sulfate, subjects will undergo surgery to implant the drug pump (SynchroMed Infusion System) and spinal catheter. The pump will deliver morphine directly to the spinal cord for pain control.
16131393|NCT01924182|Other|Conventional Medicine|Subjects will continue to use pain medications as prescribed by their doctor.
16131394|NCT01924169|Drug|Lenalidomide|"5 mg/day by mouth on Monday, Wednesday and Friday for 3 months. Process repeated for up to 2 years.
~If IgG levels do not improve, frequency of lenalidomide increased to 5 mg/day by mouth for additional 3 months and if response is achieved, lenalidomide continued at 5mg/day 3 month on/3 month off for a total of 2 years."
16131395|NCT01924169|Biological|Influenza Vaccine|Administered as injection yearly, during the fall/winter season.
16131396|NCT01924169|Biological|Pneumovax Vaccine|Administered by injection once between month 6 and month 21. Patients, who have received the Pneumovax vaccine within last 5 years, will not receive Pneumovax vaccination.
16131397|NCT01924156|Biological|adenovirus-transfected DC + CIK|adenovirus-transfected DC vaccine plus CIK cells
16131398|NCT01924143|Drug|TD-9855|radiolabeled (100 µCi [14C]-Labeled) TD-9855 (20 mg)
16131399|NCT01924130|Other|Classroom feeding|Students are fed breakfast in the classroom at the start of the school, rather than the cafeteria before school.
16131400|NCT01924130|Behavioral|Nutrition education lessons|Students receive breakfast specific nutrition education lessons.
16131401|NCT01924130|Behavioral|Social Marketing|A social marketing campaign designed to promote consumption of one healthy breakfast a day. The marketing includes a healthy breakfast points-based reward program designed by the students and promotional campaigns.
16131402|NCT01924130|Behavioral|Parent outreach|A variety of communication methods that engage families and offer education that meets their needs, including school breakfast menus, parent newsletters, and information tables at parent-teacher meetings.
16131403|NCT01924117|Other|Linear Array HPV Genotyping assay|All samples with the suspicion of squamous intraepithelial lesion were processed with the Linnear Array methodology to identify HPV genotypes
16131404|NCT01924104|Drug|Low molecular weight heparin|2500 mIU/day, subcutaneously
16131405|NCT01924104|Drug|Low dose aspirin|75 mg/day, orally
16131406|NCT01924104|Drug|Heparin & aspirin|Aspirin (70 mg/day, orally) & heparin (40 mg/day, subcutaneously)
16131407|NCT01924104|Other|NaCl|Equivalent volume of NaCl 0.9%, subcutaneously
16131408|NCT01924091|Drug|Dapivirine gel|
16131409|NCT01924091|Drug|Dapivirine film|
16131410|NCT01924078|Drug|Capecitabine|metronomic use: capecitabine 500mg/tid
16131411|NCT01924078|Drug|aromatase Inhibitors (AIs)|Anastrozole 1mg/day p.o,Exemestane 25mg/day,Letrozole 2.5mg/day p.o.
16131412|NCT01924065|Procedure|Cardioversion|Electrical cardioversion
16131413|NCT01924065|Drug|Oral Anticoagulant|warfarin, dabigatran etexilate, rivaroxaban, apixaban, edoxaban usage
16131414|NCT01924052|Drug|CGRP|Calcitonin-gene-related-peptide (CGRP)
16131415|NCT01924039|Behavioral|Brief Motivational Enhancement Therapy|The MET intervention consists of two 45 minute one-to-one sessions with a MET-trained therapist. The MET approach assists individuals to move through increasingly higher levels of change towards action (making change) and maintaining change. The MET approach aims to invoke rapid and internally motivated change with respect to substance use.
16131416|NCT01924039|Other|treatment as usual|Treatment as usual includes case management as well as psychiatric appointments.
16131447|NCT01923818|Drug|rivaroxaban|orally active direct factor Xa inhibitor
16131448|NCT01923818|Drug|Aspirin|non-steroidal anti-inflammatory drugs
16131449|NCT01923818|Drug|placebo|
16131417|NCT01924013|Dietary Supplement|Vitamin D3 (cholecalciferol)|The intervention is an oral tablet containing vitamin D3 (cholecalciferol). This vitamin D supplement will be provided in the form of small tablets (approximately 10 mm diameter) and will be custom- manufactured by Toronto Institute for Pharmaceutical Technology (TIPT) in Toronto, Ontario, Canada. Each weekly dose will consist of a single tablet. Across trial groups, the tablets will only vary with respect to the vitamin D3 dose, as described above.
16131418|NCT01924013|Dietary Supplement|Placebo|This product will be identical in appearance, taste and texture to the experimental formulation but will not include any vitamin D3.
16131419|NCT01924000|Drug|Minoxidil lotion 1%|Minoxidil lotion 1% is applied twice daily to one eyebrow.
16131420|NCT01924000|Drug|Placebo|
16131421|NCT01923987|Radiation|Short Course Radiotherapy|Radiotherapy to tumor and draining lymph node with 25 Gy in 5 fractions within 5 working days
16131422|NCT01923987|Drug|Chemotherapy|"Oxaliplatin 85 mg/m2 IV over 2 hrs on Day 1
~Irinotecan 180 mg/m2 IV over 30-90 mins on Day 1
~Leucovorin 400 mg/m2 IV over 2 hrs on Day 1 and 2
~5-fluorouracil bolus 400 mg/m2 IV push on Day 1 and 2 (or 5-fluorouracil infusion 600 mg/m2 IV continuous infusion over 22 hrs).
~Bevacizumab 5 mg/kg IV over 90 mins on Day 1
~Cetuximab (only for patients with K-ras wild type and positive EGFR mutation) 400 mg/m2 IV over 2 hrs on Day 1, and 250 mg/m2 IV over 1 hr on Day 8, 15, 22, 29, and 36.
~FOLFOX or FOLFIRI (+-Bevacizumab ) repeats every 14 days for up to 3 courses. Cetuximab repeats every week for up to 6 courses
~Postoperative FOLFOX or FOLFIRI (+-Bevacizumab or Cetuximab) for up to 9 cycles (total 12 cycles)"
16131423|NCT01923987|Procedure|Delayed Surgery|If primary tumor and metastases is resectable after FOLFOX or FOLFIRI (+-Bevacizumab or Cetuximab) of 3 cycles, patients have surgical resection (and/or radiofrequency ablation to metastases).
16131424|NCT01923974|Drug|Melatonin 10 mg|
16131425|NCT01923974|Drug|Melatonin 100 mg|
16131426|NCT01923974|Drug|Placebo|
16131427|NCT01923961|Procedure|HDF NaCl|
16131428|NCT01923961|Procedure|Hemodialysis|
16131429|NCT01923961|Procedure|Standard Predilution Hemodiafiltration|
16131430|NCT01923948|Drug|Pregabalin|One 150 mg oral dose of Pregabalin given before surgery
16131431|NCT01923948|Drug|Placebo (for Pregabalin)|One oral dose of placebo given before surgery
16131432|NCT01923935|Drug|BUSULFEX®|BUSULFEX® 3.2 mg/kg/day iv once daily over 3 hours (day-6~day-4)
16131433|NCT01923935|Drug|Alkeran®|Alkeran® 70 mg/m2/day iv once daily over 30 minutes (day-3~day-2)
16131434|NCT01923922|Radiation|CT Perfusion|The CT perfusion scan will be performed on a multi-detector CT scanner at the time of routine preoperative neuronavigation imaging. A non-contrast CT head scan will be acquired to localize the tumour. Four 5 mm thick slices will be selected at the level of the tumour. Multiple images will be acquired at each levels starting 5 sec after the injection of 50 cc of non-ionic iodinated contrast media at a rate of 4 cc/sec. The acquisition parameters will be 80 kVp and 100 mA. The images will be acquired every second for a total of 110 sec. The post- processing will be performed and parameters will be calculated using regions of interest in the areas of tumour showing the highest perfusion values. Another region of interest will be placed in the contralateral normal looking white matter.
16131435|NCT01923909|Drug|Intra-articular platelet-rich plasma|Intra-articular platelet-rich plasma This involves withdrawal of 10-15cc of patient's blood, which is collected and centrifuged in Rotofix 32 A Centrifuge machine at 1500 cycles/minute for 5 minutes. 3-4cc of the PRP is obtained and injected into the supra patellar pouch using an aseptic technique. The procedure will be performed by the principal investigator, a qualified consultant Orthopedic surgeon. Analgesia will be administered as needed.
16131436|NCT01923909|Drug|Intra-articular corticosteroid injections|Patients receiving the IA corticosteroid will be injected 3mL of 0.5% Bupivacaine and 2mL of 80mg Depo Medrol in a 10cc syringe, using an aseptic technique into the supra patellar pouch. After an IA corticosteroid injection, patients are always advised to rest for 24 hours, and weigh bear as little as possible for the following 3 days. The procedure will be performed by a senior resident with several years of experience or a consultant Orthopedic surgeon.
16131437|NCT01923896|Behavioral|Behavioral Intervention|Behavioral intervention targeting severe feeding disorders involves the combination of escape extinction and antecedent manipulation of food presentation to lessen the aversive quality of the meal. This allows treatment to address the consequences maintaining food refusal in the least restrictive environment while ameliorating possible side effects associated with extinction procedures.
16131438|NCT01923896|Drug|d-cycloserine (DCS)|
16131439|NCT01923896|Drug|Placebo|lactose powder
16131440|NCT01923883|Procedure|EUS-FNA|EUS-guided fine needle aspiration will be performed by a single experienced endoscopist (D.H.P) using a conventional linear array echoendoscope (GF-UCT240, Olympus Optical Tokyo, Japan) under conscious sedation with midazolam and meperidine. After the optimal puncture site was determined, a puncture will be done using a 22-gauge EchoTip needle (Cook Endoscopy, Winston-Salem, NC) guided by real-time EUS imaging. Subsequently, the stylet will be slowly removed as the needle is moved to-and-fro for 15 times (capillary sampling method with stylet slow-pull technique) or negative-pressure 10 mL syringe will be applied (negative-pressure syringe suction). A total of 4 needle passes will be done for the lesion with using above two aspiration methods alternatively.
16131441|NCT01923883|Device|Echoendoscope Olympus GF-UCT240|
16131442|NCT01923870|Drug|Androxal 25 mg|
16131443|NCT01923857|Drug|Androxal 25 mg|
16131444|NCT01923844|Drug|exogenous surfactant|Preparations of poractantalfa (Curosurf, 200 mg/kg) (n = 15) or beractant (Survanta, 100 mg/kg) (n = 15) were administered in a consecutive randomized manner within the first 6 h of life. During the procedure, the tube was disconnected from the ventilator. The patient's head was held in a neutral position and surfactant preparations were given in two bolus fractions. Manual ventilation was given for 2 min after each dose. After the second dose, the endotracheal tube was reconnected and the physician (D.T.) observed the infant for 30-60 s until the oxygen saturation reached > 90% on pulse oximetry. Thereafter, the peak inspiratory pressure of the 6 ventilator was reduced by 1-2 mmH2O.
16131445|NCT01923831|Drug|Magnesium Sulfate|Magnesium sulfate 30 mg kg-1 was infused in 100mL normal saline for 10 minutes immediately before anesthesia induction. After tracheal intubation, normal saline 1.6mL ( equivalent volume as Dexamethasone 8mg) was injected, and magnesium sulfate was continuously infused at the rate of 10 mg Kg-1 h-1 until the end of surgery. (at the time of skin closure)
16131450|NCT01923805|Device|Vitagel|Vitagel
16131684|NCT01922024|Device|LRT55 Testing|Testing on the Unyvero LRT55
16131451|NCT01923766|Drug|Cytotoxic T lymphocytes (CTLs).|"This Phase I dose-escalation trial is designed to evaluate the safety of donor-derived cytotoxic T lymphocytes (CTLs). Dose escalation is guided by the modified continual reassessment method (mCRM) in order to determine the maximum tolerated dose (MTD). For each group, MTD is defined as the dose at which the probability of DLT is at most 21%. Four dose levels are being evaluated namely, 5x106 cells/m2, 1.0x107 cells/m2, 1.5x107 cells/m2 and 2.5x107 cells/m2 with prior probabilities of toxicity estimated at 5%, 7.1%, 10% and 21%, respectively.
~Two patients are allocated in each cohort and are followed for 30 days post IV injection for evaluation of DLTs. The trial continues until a minimum of 12 patients have been treated and stop when the maximum 18 patients have been treated."
16131452|NCT01923753|Device|Aerosure at 15 Hz|Active Aerosure HFAO device operating at lower frequency
16131453|NCT01923753|Device|Aerosure at 25 Hz|Active Aerosure HFAO device operating at higher frequency
16131454|NCT01923753|Device|Sham Aerosure|Deactivated but identical Aerosure HFAO device
16131455|NCT01923740|Device|XIENCE V EECSS|Subjects receiving XIENCE V
16131456|NCT01923740|Device|Absorb BVS System|Subjects receiving Absorb BVS System
16131457|NCT01923727|Biological|[89Zr]Df-IAB2M|A single intravenous infusion of 5 mCi of [89Zr]Df-IAB2M in a mass dose of 10 mg, 20mg or 50mg.
16131458|NCT01923701|Behavioral|Cognitive Behavioral Therapy|GF-CBT focuses on teaching emotional self-regulation, information processing, decision making strategies,and logical thinking skills. The program is comprised of three parts: 1) Group sessions in which adolescents receive social support from peers who have had similar experiences and learn CBT skills, 2) Family group sessions in which family members learn more about adolescents' experiences and learn CBT skills so that they can encourage and reinforce these skills at home, and 3) Individual sessions in which adolescents can apply CBT skills to their own lives and work toward personal goals. Group sessions are taught with Powerpoint slides and with an accompanying workbook.
16131459|NCT01923688|Other|Informatics Alert/Nurse/physician responders|
16131460|NCT01923675|Other|Spectacles with red-blocking tint|Eyeglasses will have lenses that will correct refractive error for each subject, and will have a tint that blocks red light.
16131461|NCT01923675|Other|Spectacles with holographic diffuser and color neutral tint|Eyeglasses will correct refractive error for each subject but will have a holographic diffuser applied to the surface and will have a color neutral filter to adjust the light intensity reaching the eyes to be the same as for groups 1 and3.
16131462|NCT01923675|Other|Spectacles with holographic diffuser and red-blocking tint|Eyeglasses will correct refractive error for each subject and will be tinted to block red light, and will have a holographic diffuser to blur the image.
16131463|NCT01923675|Other|Spectacles with color neutral tint|Eyeglasses will correct refractive error for each subject and will have a color neutral tint to adjust the light intensity reaching the eyes so it is the same as for groups 1 and 3.
16131464|NCT01923662|Device|IST-16 (16-Channel implanted stimulator-telemeter|Surgical implantation of IST-16 stimulator and electrodes to stimulate paralyzed muscles. Subjects will receive exercise and physical therapy with the implanted device. Functional training and laboratory assessments of clinical and technical performance will be conducted.
16131465|NCT01923649|Drug|Lanreotide 90 mg slow release formulation|Lanreotide 90 mg slow release formulation is injected deep subcutaneously, every 4 weeks, three times and compared to placebo
16131466|NCT01923649|Drug|Placebo|Placebo for somatuline slow release 90 mg
16131467|NCT01923636|Other|detection of CMV|Clinical, radiological and laboratory (virological and immunological) standardized reports
16131468|NCT01923623|Drug|Ropivacaine block|
16131469|NCT01923610|Biological|Experimental|"Biological/Vaccine: MVA-B Modified Pox virus, strain MVA clade -B (expressing HIV-1 Bx08gp120 and IIIB gagpolnef)
~-~ 1 x 10e8 pfu/ml 3 immunisations at week 0, 4 and 16"
16131470|NCT01923597|Drug|Green tea extract|200mg/capsule Administered orally 4 capsules per day For 3 months
16131471|NCT01923584|Drug|EPI-743 400mg|
16131472|NCT01923584|Drug|EPI-743 200mg|
16131473|NCT01923571|Other|intraoperative BGC measure|
16131474|NCT01923558|Drug|Donepezil|Donepezil Hydrochloride tablets,23 mg
16131475|NCT01923545|Drug|PEG-G-CSF|Vial, 3.6mg/day or 6mg/day, single dosing per cycle, for 1 cycle
16131476|NCT01923545|Drug|G-CSF|Vial, 100ug/m2/day, multiple dosing per cycle(daily administration, up to 10 days), for 1 cycle
16131477|NCT01923519|Procedure|bronchofiberscopy|
16131478|NCT01923506|Radiation|stereotactic body radiation therapy|Undergo SBRT
16131479|NCT01923506|Procedure|quality-of-life assessment|Ancillary studies
16131480|NCT01923506|Other|laboratory biomarker analysis|Correlative studies
16131481|NCT01923493|Other|tuina|Patients in the tuina group will receive a tuina therapy (also known as Chinese massage). A Chinese massage lasts about 20 to 30 minutes. A series of 6 sessions with 2 treatments per week is applied.
16131482|NCT01923493|Other|no intervention|Patients in the no intervention waiting list group will not receive a study intervention. They will continue their respective pre-study therapy during the study period.
16131483|NCT01923480|Drug|15% CLINISOL - Sulfite-free (Amino Acid) Injection|
16131484|NCT01923480|Drug|15% CLINISOL - Sulfite-free (Amino Acid) Injection|
16131485|NCT01923480|Drug|15% CLINISOL - Sulfite-free (Amino Acid) Injection|
16131486|NCT01923467|Behavioral|Project Quit stop smoking program|This online stop-smoking program is individually tailored to the participant's readiness to quit, smoking triggers, and many other characteristics. It has been scientifically proven to improve quit success.
16131487|NCT01923467|Drug|Nicotine patches 21 mg|Eligible participants will receive a 2-week supply of Nicoderm CQ Step 1 patches to help them be successful in their quit attempt.
16131488|NCT01923454|Procedure|Paracentesis|At presentation, patients received immediate anterior chamber paracentesis with a 30-gauge needle. The intraocular pressure (IOP) was recorded at immediately, 15 and 30 minutes, and then 1, 24 and 48 hours after paracentesis. The IOP was compared between before paracentesis and each time-point after paracentesis. All affected eyes received antiglaucomatous medications 60 minutes after ACP and underwent peripheral iridotomy within 24 hours.
16131489|NCT01923454|Drug|Acetazolamide|All participants will receive oral acetazolamide (250 mg) 1 tablet at 1 hour after paracentesis to lower the intraocular pressure. After that, the dose of acetazolamide will be adjusted according to the level of intraocular pressure. If the eye pressure goes to normal (lower than 21 mmHg), acetazolamide will be discontinued.
16131490|NCT01923454|Procedure|Peripheral iridotomy|All affected eyes underwent laser peripheral iridotomy within 24 hours after presentation. This procedure is a standard treatment for acute angle-closure. The fellow eyes will receive laser peripheral iridotomy in the same occasion or later to prevent acute angle-closure in the future.
16131491|NCT01923428|Drug|AZD1722|
16131492|NCT01923428|Drug|Placebo|
16131493|NCT01923415|Procedure|No intervention, skin biopsy|All participants will have 2 adjacent 4 mm punch biopsies collected from uninvolved and involved skin (a total of 4 biopsies).
16131494|NCT01923415|Procedure|No intervention, blood collection|Blood for serum analyses will be taken from all participants, blood for DNA analysis only from subjects who consent to this separately.
16131495|NCT01923415|Procedure|No intervention, urine collection|Urine will be collected from all participants.
16131496|NCT01923389|Other|Placebo|0.9% w/v sodium chloride injection, United States Pharmacopeia (USP), twice a week for 4 weeks.
16131497|NCT01923389|Drug|100 mg PF-05231023|100 mg IV infusion twice a week for 4 weeks
16131498|NCT01923376|Drug|Lactulose|If randomized to this group, subjects will receive 10 - 30 grams of lactulose per standard of care
16131499|NCT01923376|Drug|Polyethylene Glycol 3350|If subject is randomized to this group, one time dose of one gallon polyethylene glycol 3350 will be given at the time of enrollment
16131500|NCT01923363|Drug|Piperacillin/Tazobactam Standard Dose to High Dose|Patients will receive a standard dose of piperacillin/tazobactam, then will have subsequent pharmacokinetic analyses on the blood concentrations drawn while on standard dose. Patients will be switched to higher dose after receiving the standard dose, with subsequent pharmacokinetic analyses performed on those blood concentrations while on higher dose. These pharmacokinetics of each dosing regimen will be compared.
16131501|NCT01923350|Behavioral|Weight Reduction Intervention|"The weight trial intervention components were:
~Electronic feedback from the ADAPT interactive obesity treatment approach (iOTA) system, tracking participants' behavior change goals. Participants received feedback either by daily SMS (text messaging) or by weekly IVR (interactive automated calls).
~Seven behavior change coaching calls, once a month for 6 months, and then one at 7.5 months halfway through the maintenance period.
~Print mailings/emailings
~3 Get Ready e-messages in the four weeks before the weight intervention began
~Pedometers and program guides. (IVR users received printed activity logs with their program guides.)
~Access to the ADAPT iOTA website for reviewing their progress and obtaining information on behavior change goals."
16131502|NCT01923350|Behavioral|Weight Reduction Control Arm|Participants received an initial brochure about managing diabetes risk, a digital scale to use in entering their weights in online questionnaires, and monthly emailed wellness messages unrelated to diabetes.
16131503|NCT01923350|Behavioral|Tested for diabetes|Due to small numbers in this group, the planned intervention was changed to a mixed-mode study, using baseline and follow-up self-administered questionnaires and semi-structured questionnaires administered to a sub-sample of those tested for diabetes to identify factors differentiating the behavior of women who had and had not been tested for diabetes following a pregnancy with gestational diabetes mellitus.
16131504|NCT01923350|Behavioral|Not tested for diabetes|Due to small numbers in this group, the planned intervention was changed to a mixed-mode study, using baseline and follow-up self-administered questionnaires and semi-structured questionnaires administered to a subsample of those not tested for diabetes to identify factors differentiating the behavior of women who had and had not been tested for diabetes following a pregnancy with gestational diabetes mellitus.
16131505|NCT01923337|Drug|irinotecan hydrochloride|Given IV
16131506|NCT01923337|Drug|alisertib|Given PO
16131507|NCT01923324|Behavioral|Physician telephone consultation|Pain physician support for family physician treating patient
16131508|NCT01923324|Behavioral|Usual family physician care|Usual family physician care without telephone consultation with pain physician
16131509|NCT01923311|Drug|EVG|Tablet (s) or tablet (s) for oral suspension (if unable to swallow) will be administered orally once daily
16131510|NCT01923311|Drug|Background regimen|Background regimen may consist of the following ritonavir (RTV)-boosted PIs (PI/r): lopinavir/r (Kaletra), atazanavir/r, darunavir/r, tipranavir/r, or fosamprenavir/r. For participants < 2 months old, only lopinavir/r is allowed. Use of additional antiretrovirals in background therapy may be allowed.
16131511|NCT01923298|Drug|Estradiol|
16131512|NCT01923285|Device|AXIUM Neurostimulator System|
16131513|NCT01923285|Device|Control Spinal Cord Stimulation Device|
16131514|NCT01923272|Device|AlphaCore Device|Active stimulation to the vagal nerve
16131515|NCT01923272|Device|AlphaCore|Active AlphaCore treatment
16131516|NCT01923259|Drug|Donepezil|Donepezil Hydrochloride tablets,23 mg
16131517|NCT01923246|Behavioral|Single WEB intervention|Brief WEB intervention recieved once
16131518|NCT01923246|Behavioral|Repeated WEB intervention|WEB intervention recieved twice.
16131519|NCT01923246|Behavioral|Single IVR intervention|IVR intervention recieved once
16131520|NCT01923246|Behavioral|Repeated IVR intervention|IVR intervention recieved twice
16131521|NCT01923233|Biological|AlloStim|allogeneic Th1 memory cell with CD3/CD28-coated microbeads attached.
16131522|NCT01923220|Drug|HO/02/02 20µg|Interventions involving HO/02/02 20µg VS. Aloe Vera Jel (SOC). Treatment will be applied topically once daily
16131523|NCT01923220|Other|Aloe Vera Jel|To be applied topically once daily
16131524|NCT01923207|Drug|DX-2930|
16131525|NCT01923207|Drug|Placebo|placebo, subcutaneous administration
16131526|NCT01923194|Drug|Highly Purified Urofollitropin|for Injection
16131527|NCT01923194|Drug|Recombinant Human Follitropin Alfa|for Injection
16131528|NCT01923181|Drug|semaglutide|Once-daily oral administration as tablets.
16131529|NCT01923181|Drug|semaglutide|Once-weekly,injected s.c./subcutaneously (under the skin) using a pen
16131530|NCT01923181|Drug|oral placebo|Once-daily oral administration as tablets.
16131531|NCT01923168|Drug|alpelisib|BYL719 + Letrozole
16131532|NCT01923168|Drug|buparlisib|BKM120 + Letrozole
16131533|NCT01923168|Drug|Placebo|Placebo (of BYL719 or BKM120) + Letrozole
16131534|NCT01923155|Procedure|Colonoscopy|
16131586|NCT01922765|Drug|amoxicillin, clarithromycin, metronidazole, rabeprazole|
16131829|NCT01921075|Other|Magnetic resonance spectroscopy|Non-invasive diagnostic procedure
16131535|NCT01923142|Biological|Outer-Root-Sheath Melanocytes Suspension|The treatment consists in depositing a suspension of autologous outer-root-sheath melanocytes, derived from patient's plucked hair follicles, and patient's own serum on the area affected by vitiligo, after properly preparation with dermabrasion. Afterwards a targeted UVB phototherapy will be carried out by patients at home for 3 days / week from the beginning of the 5th week after transplantation till the end of the study period (12th week).
16131536|NCT01923142|Biological|Placebo|The treatment consists in depositing a solution made of saline and patient's own serum on the area affected by vitiligo, after properly preparation with dermabrasion. Afterwards a targeted UVB phototherapy will be carried out by patients at home for 3 days / week from the beginning of the 5th week after transplantation till the end of the study period (12th week).
16131537|NCT01923129|Drug|Prazosin given 6 hours prior to catheter removal in the 24 hour group|Prazosin given orally (1 mg) 6 hours prior to catheter removal (hour 18 postoperatively)
16131538|NCT01923116|Drug|HPV-16 vaccine|Vaccination with SLP-HPV-01® with or without interferon-a injections.
16131539|NCT01923090|Drug|Finasteride|Finasteride 5mg once daily for 3 weeks
16131540|NCT01923090|Drug|Dutasteride|Dutasteride 0.5mg once daily for 3 weeks
16131541|NCT01923077|Drug|Simvastatin|usual care with Simvastatin
16131542|NCT01923077|Drug|Rosuvastatin|rosuvastatin 80 mg as loading dose at randomization followed by rosuvastatin 40 mg daily.
16131543|NCT01923064|Drug|Lipiodol|endoscopic injection of lipiodol + cyanoacrylate + lipiodol for gastric varices
16131544|NCT01923064|Drug|Lauromacrogol|endoscopic injection of lauromacrogol + cyanoacrylate + lauromacrogol for gastric varices
16131545|NCT01923038|Procedure|First arm: patients ventilated with zero end expiratory pressure|
16131546|NCT01923038|Procedure|Patients ventilated with Positive End Expiratory Pressure|
16131547|NCT01923038|Procedure|Patients ventilated with Positive End Expiratory Pressure plus Recruitment maneuver|
16131548|NCT01923025|Drug|RO5545965|Single dose
16131549|NCT01923012|Drug|Vitamin K2 (Menaquinone)|
16131550|NCT01922999|Drug|Melatonin|patients will receive placebo, 1mg melatonin or 3mg melatonin
16131551|NCT01922986|Device|active rTMS|10 minutes of real high-frequency (6-Hz) rTMS priming (total priming pulses = 600) plus 10 minutes of low-rate (1Hz) rTMS (total low-rate pulses = 600).
16131552|NCT01922986|Device|sham rTMS|20 minutes of sham rTMS stimulation
16131553|NCT01922986|Behavioral|conventional stroke therapy|conventional stroke therapy consisting of exercises and physical training
16131554|NCT01922973|Other|Fasting|normal volunteers fast from food on one occasion for 62.5 h; on another occasion fed 3 meals
16131555|NCT01922960|Other|micro-imaging|micro-imaging
16131556|NCT01922947|Behavioral|Motivational Interviewing w/Social Network Counseling|This is the active arm of the study.
16131557|NCT01922947|Behavioral|Active Control Condition|20-minute health counseling
16131558|NCT01922934|Behavioral|Commercial weight loss program|vouchers for Weight Watchers
16131559|NCT01922934|Behavioral|Colorado Weigh|Group behavioral weight loss program
16131560|NCT01922934|Dietary Supplement|Meal replacements|Health Management Resources meal replacement products (shakes and entrees)
16131561|NCT01922934|Drug|Obesity pharmacotherapy|Phentermine or phentermine-topiramate (Qsymia)
16131562|NCT01922934|Behavioral|Recreation center passes|1 year pass to a Denver recreation center
16131563|NCT01922921|Biological|HER-2/neu Intracellular Domain Protein|Given ID
16131564|NCT01922921|Other|Laboratory Biomarker Analysis|Correlative studies
16131565|NCT01922921|Biological|Pertuzumab|Given per standard of care
16131566|NCT01922921|Other|Placebo|Given PO
16131567|NCT01922921|Biological|Polysaccharide-K|Given PO
16131568|NCT01922921|Biological|Trastuzumab|Given per standard of care
16131569|NCT01922908|Biological|MSC Infusion|Allogeneic bone marrow derived mesenchymal stem cells given in one dose 3-10 days after stroke symptom onset
16131570|NCT01922908|Biological|Placebo Comparator|Normal saline
16131571|NCT01922895|Dietary Supplement|Lactobacillus Rhamnosus GG|Probiotic nutritional supplement; Lactobacillus Rhamnosus GG
16131572|NCT01922895|Drug|Placebo for Probiotic|Capsule manufactured without active ingredients.
16131573|NCT01922882|Behavioral|Amagugu Counseling Intervention|6-session home-based counseling intervention delivered by lay counselors at mothers' homes
16131574|NCT01922869|Dietary Supplement|Flavonoids|
16131575|NCT01922856|Biological|LTR192G with dscCfaE|Recombinant fimbrial adhesin (dscCfaE) with Modified Escherichia coli (E coli) heat labile enterotoxin (LTR192G)
16131576|NCT01922856|Other|No Intervention|Controls only receive challenge
16131577|NCT01922843|Drug|DP001 softgel capsules|
16131578|NCT01922843|Drug|Placebo|
16131579|NCT01922830|Dietary Supplement|Bio-25 (Supherb)|The Bio-25 (Supherb) is a probiotic supplement consisting of 11 different species of patented probiotic bacteria and over 25 billion active bacteria in each capsule. The bacteria in the formula are patented bacteria that have undergone drying, freezing, and double coating which ensures their survival under stomach acidity conditions and their enrooting in the intestines.
16131580|NCT01922830|Dietary Supplement|Placebo (for Bio-25, Supherb)|A pill manufactured to mimic Bio-25 (Supherb) pill
16131581|NCT01922817|Drug|Saxagliptin|5mg saxagliptin
16131582|NCT01922804|Dietary Supplement|K2 vitamin|K2 vitamin tablet
16131583|NCT01922804|Dietary Supplement|Placebo|Placebo tablets
16131584|NCT01922791|Dietary Supplement|Comparison of probiotics, fish oil and their combination to placebo|Double-blind randomized placebo controlled intervention
16131585|NCT01922778|Procedure|Endometrial Biopsy|"Recruits from the Bariatric Surgery Program will be interviewed by a study investigator prior to their bariatric surgery. During the interview, the purpose of the study will be explained as well as the surgical technique used for obtaining an endometrial sample. If the patient consents to the procedure, then this will usually be a D&C performed in one setting at the time of her bariatric surgery under general anesthesia. In the case where a patient is diagnosed with complex atypical endometrial hyperplasia or early endometrial prior to her bariatric surgery, an IUD can be inserted at the time of her bariatric surgery.
~For patients not undergoing bariatric surgery, an endometrial biopsy will be performed in the clinic or office setting using an endometrial suction catheter."
16131587|NCT01922752|Drug|CEP-37440|"CEP-37440 will be supplied as 25 mg and 100 mg capsules and will be orally administrated daily.
~Patients will be enrolled sequentially in dose escalating cohorts to receive CEP-37440 until a maximum tolerated dose has been defined."
16131588|NCT01922739|Drug|Hydrocodone ER|Participants were instructed to take hydrocodone ER tablets orally with a glass of water on an empty stomach at least 1 hour before or 2 hours after eating.
16131589|NCT01922739|Drug|Placebo|During the double-blind titration period used in the original protocol, placebo tablets matching each dose of hydrocodone bitartrate ER tablets (active drug) were used to maintain the blind but not for purposes of comparison.
16131590|NCT01922713|Other|white maize and a corn oil capsule|~ 0 ug RAE/d
16131591|NCT01922713|Other|orange maize and a corn oil capsule|~600 ug RAE/d
16131592|NCT01922713|Other|white maize and a vitamin A capsule|600 ug RAE/d
16131593|NCT01922687|Drug|amlodipine plus atorvastatin (Caduet)|
16131594|NCT01922687|Drug|amlodipine (Norvasc)|
16131595|NCT01922674|Procedure|Standard open tension-free inguinal hernia repair with mesh|
16131596|NCT01922661|Drug|REGN1908-1909|
16131597|NCT01922661|Other|placebo|
16131598|NCT01922648|Procedure|Blood sample|An extra volume of blood is obtained, with prior consent, when phlebotomy is required for another unrelated clinical reason.
16131599|NCT01922635|Other|Valadation of the metrological properties of questionnaire of quality of life|
16131600|NCT01922596|Drug|Ropivacaine|
16131601|NCT01922596|Drug|Placebo|
16131602|NCT01922583|Drug|AUY922|AUY922 will be administered via IV over 1 hour once weekly in a 21 day cycle until disease progression
16131603|NCT01922570|Dietary Supplement|nutrition|comparion of enteral versus enteral and supplemental parenteral nutrition
16131604|NCT01922557|Device|NICOM|NICOM monitoring thoracic fluid content at baseline(T1), anhepatic phase(T2), 30 mins after reperfusion(T3) and 2 hrs after reperfusion(T4).
16131605|NCT01922518|Procedure|Septal pacing|Put RV pacing lead around the right ventricular septum and is adjusted with normal pacing axis
16131606|NCT01922518|Procedure|Apex pacing|Put RV lead around the apex
16131607|NCT01922505|Drug|PPI triple therapy|
16131608|NCT01922492|Procedure|Autologous islet transplantation|"Islet was isolated from the normal part of resected pancreas with modified Ricordi method.
~After purification, the islets were infused into the liver through percutaneous transhepatic portal vein catheterization."
16131609|NCT01922492|Drug|Oral anti-diabetic drugs|"Metformin on the diagnosis of postoperative diabetes mellitus. Starting dose of 500mg per day and dose adjustment as needed to control blood glucose.
~Vildagliptin added on the insufficient glycemic control with monotherapy. Starting dose of 50mg per day and dose adjustment as needed to control blood glucose."
16131610|NCT01922479|Drug|Ferric Carboxymaltose|1000mg intravenous Ferric Carboxymaltose, given as undiluted slow bolus injection over 15 minutes. Allowed to take concomitant oral iron supplements in usual clinical doses as prescribed clinically by attending physicians.
16131611|NCT01922479|Drug|Placebo|20mls intravenous Normal Saline (0.9%), given as slow bolus injection over 15 minutes. Allowed to take concomitant oral iron supplements in usual clinical doses as prescribed clinically by attending physicians.
16131612|NCT01922466|Procedure|Bee Venom Acupuncture|"Bee Venom 1:20,000 under BVA Increment Protocol
~- Increment Protocol as
~1st week - SC 0.2cc/day, 2 days/week
~2nd week - SC 0.4cc/day, 2 days/week
~3nd week - SC 0.8cc/day, 2 days/week"
16131613|NCT01922466|Drug|Loxoprofen|60 mg/Tab, pers os 1Tab tid, for 3 weeks
16131614|NCT01922453|Other|Music and Sound|
16131615|NCT01922440|Drug|Combination product (Natpara) and drug or supplements [Disease and drug registry]|Interventions evaluated are combination product (Natpara) and either drug or supplements (Calcium and vitamin D)
16131616|NCT01922427|Drug|RNS60|
16131617|NCT01922414|Device|Laser|Patients will undergo laser lithotripsy durin PNL
16131618|NCT01922414|Device|Ultrasonic|Patients will undergo ultrasonic lithotripsy during PNL
16131619|NCT01922401|Other|inverse ratio ventilation|change the I: E ratio 1:2-1:1-2:1
16131620|NCT01922388|Device|Bilateral deep brain stimulation of the subthalamic nucleus|
16131621|NCT01922375|Drug|Naftopidil|
16131622|NCT01922362|Device|Negative pressure drainage system|a close system surgical drain was placed over the graft with the length equal to the wound size. A silicon penrose drain with side holes on it covered the surgical drain to prevent direct contact of transparent film and the surgical drain, which led to poor drainage function. The penrose drains were excluded from the system during the test period due to the same function of a close system surgical drain with and without a penrose drain. A transparent film was place over the graft and drains and over a margin of the surrounding healthy skin.
16131623|NCT01922362|Device|Indirect wet dressing|The recipient site wound is covered with sulfa-tula first and then wet gauze.
16131624|NCT01922349|Drug|BI 113608|Medium dose (Multiple dosing)
16131625|NCT01922349|Drug|Placebo|Placebo (Multiple dosing)
16131626|NCT01922349|Drug|BI 113608|Low dose (Multiple dosing)
16131627|NCT01922349|Drug|Placebo|Placebo (Single dosing)
16131628|NCT01922349|Drug|BI 113608|High dose (Single dosing)
16131629|NCT01922349|Drug|BI 113608|Medium dose (Single dosing)
16131630|NCT01922349|Drug|BI 113608|Low dose (Single dosing)
16131631|NCT01922349|Drug|BI 113608|High dose (Multiple dosing)
16131632|NCT01922336|Biological|SB2|IV infusion
16131633|NCT01922336|Biological|EU Remicade|IV infusion
16131634|NCT01922336|Biological|US Remicade|IV infusion
16131635|NCT01922310|Behavioral|Communication intervention|"The intervention is a modification of current standard practice procedures for requesting consent for donation.
~The intervention period commences when the possibility of organ donation is first raised with the family, and includes the time for families to make a decision. This time may last up to 72 hours."
16131678|NCT01922050|Drug|LEO 43204 Formulation 1 Dose Y|
16131679|NCT01922050|Drug|LEO 43204 Formulation 2 Dose XX|
16131680|NCT01922050|Drug|LEO 43204 Formulation 2 Dose YY|
16131681|NCT01922050|Drug|Placebo Formulation 1|
16131682|NCT01922050|Drug|Placebo Formulation 2|
16131683|NCT01922037|Drug|Omalizumab|Participants will receive omalizumab for up to 12 months per investigator standard of care and clinical practice.
16131636|NCT01922297|Other|Day Treatment MDFT-HIV|MDFT-HIV is a specialized intervention aimed at reducing risk factors for HIV-associated sexual behaviors. It builds protective behaviors in the adolescent's intrapersonal and interpersonal functioning, as well as those aspects of family functioning to reduce youths' high-risk sexual behavior. For instance, interventions target inadequate monitoring, parent-adolescent conflict, and parental disengagement - behaviors consistently associated with elevated HIV/STD risk. It facilitates positive and supportive family relationships, processes that can significantly reduce HIV/STD risk. Additionally, it aims to promote effective family communication about sexuality and safer sexual behaviors, among the most important protective factors against sexual risk taking behavior.
16131637|NCT01922297|Other|Day Treatment SAU|Substance abuse treatment and HIV prevention services are routinely provided to youth in the day treatment programs. The day treatment programs contract to local substance abuse and mental health providers for these services that are provided both within and outside of the day treatment setting. The intervention's specific features are similar to those found in the literature on outpatient peer-based group treatment for adolescent alcohol abusers (CSAT 1998). Specifically, it is based on a cognitive-behavioral group treatment model (Kaminer et al 1998; Marshall & Marshall 1993), with a comprehensive treatment package including individual counseling and treatment planning.
16131638|NCT01922284|Biological|DNA|8mg DNA: one plasmid encoding a gag-pol-nef polypeptide derived from the 96ZM651-8 clone and one plasmid encoding gp140 env derived from clade C 97CN54
16131639|NCT01922284|Biological|MVA-C|1.108 TCID50 MVA-C (nominal titre) expressing the gag-pol-nef and gp120 env proteins derived from clade C 97CN54
16131640|NCT01922284|Biological|CN54rgp140|100ug CN54rgp140, a trimeric recombinant envelope protein derived from clade C 97CN54
16131641|NCT01922284|Biological|GLA-AF|5ug GLA-AF, an aqueous glucopyranosyl lipid A adjuvant
16131642|NCT01922271|Drug|NVA237|NVA237 44 µg inhalation capsules once daily, delivered via single-dose dry-powder inhaler (SDDPI)
16131643|NCT01922271|Drug|Tiotropium|Tiotropium 18 μg once daily delivered via HandiHaler® device.
16131644|NCT01922271|Drug|Placebo to NVA237|Placebo to NVA237 once daily, delivered via single-dose dry-powder inhaler (SDDPI).
16131645|NCT01922271|Drug|Placebo to tiotropium|Placebo to tiotropium once daily delivered via HandiHaler® device
16131646|NCT01922271|Drug|Salbutamol|Used as resuce medication
16131647|NCT01922258|Drug|Brexpiprazole, OPC-34712|Flexible dose of 0.5 to 2 mg/day or placebo tablets for up to 12 weeks
16131648|NCT01922245|Device|Soterix 1x1 tDCS|Anodal and sham tDCS will be administered. All of the participants will also receive behavioral speech-language therapy.
16131649|NCT01922219|Behavioral|Cognitive Behavioral Therapy|14 sessions of individual psychotherapy (cognitive behavioral therapy) for depression over 12 weeks
16131650|NCT01922206|Behavioral|TRACK Intervention|"TRACK Intervention
~3-session, individually administered psycho-educational intervention to promote maternal disclosure of HIV status to child"
16131651|NCT01922193|Drug|Highly Purified Urofollitropin|for injection
16131652|NCT01922193|Drug|Recombinant Human Follitropin Alfa|for injection
16131653|NCT01922180|Radiation|Chest CT scans|CT examinations were performed with a commercially available 64-detector row scanner. Images were acquired in supine position after full inspiration and full expiration, using the following parameters: slice thickness, 0.6 mm; pitch, 1.4; rotation time, 330 msec; tube voltage, 120 kiloVolts; and tube current-time product, 100 milliAmperes, with automatic exposure control (CareDose 4D, Siemens Healthcare) switched on. From raw data, 1-mm-thick section images were reconstructed at 0.7-mm intervals by using a high spatial algorithm and a soft-tissue algorithm. The inspiratory CT scan at the time of exacerbation was performed with intravenous iodinated contrast material, whereas the control scan was unenhanced.
16131654|NCT01922167|Dietary Supplement|Leucine|
16131655|NCT01922167|Dietary Supplement|Alanine|
16131656|NCT01922154|Drug|intravitreal ranibizumab|The patients received IVR (0.5 mg in 0.05 ml) injection through the pars plana in the operating room. A fornix-based conjunctival flap technique trabeculectomy with intraoperative mitomycin C was performed within 2 weeks after IVR.
16131657|NCT01922154|Procedure|Trabeculectomy with mitomycinC|All participant underwent trabeculectomy with mitomycinC , which is the standard procedure for refractory glaucoma.
16131658|NCT01922141|Drug|Aliskiren|Aliskiren 150 mg and aliskiren 300 mg tablets will be supplied centrally. These will be blinded with matching placebos for the 2 dose strengths.
16131659|NCT01922141|Drug|Amlodipine|Amlodipine 5 mg/10 mg will also be blinded and supplied centrally. For Aliskiren dual therapy arm , Amlodipine is in the regimen; where as for monotherapy arms, Amlodipine is an optional add-on therapy.
16131660|NCT01922141|Drug|Ramipril|Ramipril 5 mg and ramipril 10 mg capsules will be supplied centrally. These will be blinded with matching placebos for the 2 dose strengths.
16131661|NCT01922141|Drug|Hydrochlorothiazide|Hydrochlorothiazide 12.5 mg/25 mg will be open label and supplied locally. It is an optional add-on to each arm.
16131662|NCT01922128|Drug|MC-1101, Placebo|One drop 0.5%; MC-1101; One drop 1.0% MC-1101, One drop Placebo
16131663|NCT01922115|Drug|Trospium Chloride|Subject will be administered either placebo or 60 mg dosage of Sanctura XR for treatment of overactive bladder. Subject will take Sanctura XR once every morning. Blood will be drawn for plasma extraction at each visit.
16131664|NCT01922115|Drug|Placebo|
16131665|NCT01922102|Drug|Ranibizumab 0.5mg|0.5 mg ranibizumab (intravitreal injections)
16131666|NCT01922102|Drug|Ranibizumab 0.5 mg|0.5 mg ranibizumab (intravitreal injections)
16131667|NCT01922102|Drug|Verteporfin PDT|Verteporfin for intravenous injection delivered by intravenous infusion followed by the light application
16131668|NCT01922089|Drug|LCZ696|LCZ696 50 mg/100 mg/200 mg bid
16131669|NCT01922076|Drug|Adavosertib|Given PO
16131670|NCT01922076|Other|Laboratory Biomarker Analysis|Correlative studies
16131671|NCT01922076|Other|Pharmacological Study|Correlative studies
16131672|NCT01922076|Radiation|Radiation Therapy|Undergo radiation therapy
16131673|NCT01922063|Behavioral|Physiotherapy Intervention|20x 30 min sessions of physiotherapy
16131674|NCT01922063|Behavioral|Sham neck massage|20x 30 minutes sessions of neck massage
16131675|NCT01922050|Drug|LEO 43204 Formulation 1|
16131676|NCT01922050|Drug|LEO 43204 Formulation 2|
16131677|NCT01922050|Drug|LEO 43204 Formulation 1 Dose X|
16131685|NCT01922011|Drug|Daptomycin|IV daptomycin Infusion A in 12 to <18 years old (7 mg/kg); in 7 to < 12 year olds (9 mg/kg); in 24 months to <7 year olds (12 mg/kg); in 12 to <24 month olds (12 mg/kg). Infused over 60 minutes ± 10 minutes once daily followed by up to 3 dummy infusions every 6 hours (q6h) infused over 60 (± 10) min to maintain the blind.
16131686|NCT01922011|Drug|Vancomycin (or equivalent)|IV vancomycin (or equivalent) (Infusions A,B,C,D), 10 to 15 mg/kg, infused over 60 (± 10) minutes q6h (± 1 hour)
16131687|NCT01922011|Drug|Nafcillin (or equivalent)|IV nafcillin (or β-lactam equivalent) (Infusions A,B,C,D) at 100-200 mg/kg/day, in divided doses infused over 60 (± 10) min q6h (± 1 hour)
16131688|NCT01921998|Procedure|Biomarker and health economics|Biomarkers CK18 and FLT3 Ligand will be collected
16131689|NCT01921985|Drug|Terlipressin|Terlipressin given as intravenous injections of 1mg iv in 100ml of NaCl every 6 hours (total duration of drug administration 120 hours, cumulative dose is 20mg).
16131690|NCT01921985|Drug|Placebo|Placebo (Saline 100 ml) administered every 6 hours (total duration of drug administration 120 hours).
16131691|NCT01921972|Drug|Galantamine CR|24 mg/day with dose-titration over twelve weeks
16131692|NCT01921972|Drug|Memantine|memantine 10 mg b.i.d. with a dose titration of sixteen weeks
16131693|NCT01921972|Drug|Placebo|Placebo will be similar in appearance to Memantine
16131694|NCT01921959|Behavioral|Intervention|Postpartum women are randomized to intervention or control group
16131695|NCT01921946|Drug|Fimasartan|
16131696|NCT01921946|Drug|Rosuvastatin|
16131697|NCT01921933|Device|Optiflow|The Optiflow device will be implanted in the upper extremity of Adult end-stage renal disease (ESRD) patients requiring creation of an upper extremity autogenous arteriovenous fistula for dialysis access.
16131698|NCT01921920|Drug|Omeprazole|Omeprazole 20 mg (AstraZeneca - test) Omeprazole 40 mg (AstraZeneca - test) Omeprazole 20 (Merck - reference) Omeprazole 40mg (Merck - reference)
16131699|NCT01921907|Drug|AD17137 topical treatment|
16131700|NCT01921907|Drug|Placebo|
16131701|NCT01921894|Dietary Supplement|Cholecalciferol|vitamin D supplementation with either 2,000 IU/day or 4,000 IU/day compared to vitamin D3 supplementation with 200 IU/day.
16131702|NCT01921881|Other|St John's wort|
16131703|NCT01921868|Drug|Acetyl-L-Carnitine|Acetyl-L-Carnitine, 2 g/day, up to 24 months.
16131704|NCT01921855|Drug|BAY Factor VII (BAY86-6150)|BAY Factor VII (BAY86-6150), 6.5 µg/kg body weight, will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1.
16131705|NCT01921855|Drug|BAY Factor VII (BAY86-6150)|BAY Factor VII (BAY86-6150), 20 µg/kg body weight, will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1.
16131706|NCT01921855|Drug|BAY Factor VII (BAY86-6150)|BAY Factor VII (BAY86-6150), 50 µg/kg body weight, will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1.
16131707|NCT01921855|Drug|BAY Factor VII (BAY86-6150)|BAY Factor VII (BAY86-6150), 90 µg/kg body weight, will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1.
16131708|NCT01921855|Drug|Placebo|Placebo will be administered as a slow intravenous (i.v.) administration over a period of 2-5 minutes (min) on Study Day 1.
16131709|NCT01921842|Behavioral|NAP-SACC Child Care Wellness Program|Nutrition And Physical activity Self-Assessment for Child Care
16131710|NCT01921829|Drug|Protocolized Diuretic Strategy|"The Protocolized Diuretic Strategy will administer diuretics according to an algorithm based on based on the stepped pharmacologic care arm used by the CARRESS-HF trial investigators. This algorithm targets a relatively aggressive goal diuresis of urine output (UO) 3-5 L/day with diuretics intensified in a stepped fashion using both loop diuretics given by intravenous (IV) bolus followed by IV continuous infusion (furosemide or alternative loop diuretic at equivalent dose), with or without concomitant thiazide diuretic (oral (PO) metolazone or IV chlorothiazide)."
16131711|NCT01921816|Device|Prismocitrate 18/0, Prism0cal|Subjects on continuous hemodiafiltration will ordinarily receive heparin as the anticoagulation. In our study, regional citrate anticoagulation with Prismacitrate is used to replace heparin. Citrate has been shown in study to be safer than heparin with reduced bleeding risk
16131712|NCT01921803|Radiation|hypofractionation|
16131713|NCT01921790|Biological|Avastin|Avastin 7.5mg/Kg, intravenous drip D1
16131714|NCT01921790|Drug|Gemcitabine|Gemcitabine 1g/m2 intravenous drip D1,D8
16131715|NCT01921790|Drug|Oxaliplatin|Oxaliplatin 130mg/m2 intravenous drip D1
16131716|NCT01921790|Drug|Pegaspargase|Pegaspargase 2500U/m2 intramuscular injection (IM) D1
16131717|NCT01921790|Drug|Dexamethasone|Dexamethasone 20mg/d intravenous drip D1, po D2-3
16131718|NCT01921777|Drug|Traumeel|oral, Day 1: one tablet every 15 minutes for two hours after the exercise test, 6 hours and 10 hours after the exercise test; Day 2 and 3: two tablets thrice daily; Day 4: two tablets in the morning
16131719|NCT01921777|Drug|Placebo|oral, Day 1: one tablet every 15 minutes for two hours after the exercise test, 6 hours and 10 hours after the exercise test; Day 2 and 3: two tablets thrice daily; Day 4: two tablets in the morning
16131720|NCT01921764|Behavioral|Workplace physical exercise|
16131721|NCT01921764|Behavioral|Home physical exercise|
16131722|NCT01921751|Radiation|low intensity radiation therapy|50.4 Gy in 28 1.8 Gy fractions (IMRT or 3D-CRT), 5 days/week, starting 3-5 weeks after the last dose of induction chemotherapy
16131723|NCT01921751|Drug|Capecitabine|825 mg/m2 PO twice daily, 5 days/week, beginning on the first day of radiation therapy and ending on the last day of radiation therapy.
16131724|NCT01921751|Drug|Gemcitabine|1000 mg/m2 weekly as a 30 minute infusion after nab-Paclitaxel, three weeks on and 1 week off [1 cycle = 4 weeks]
16131725|NCT01921751|Radiation|high intensity radiation therapy|63 Gy intensity-modulated radiation therapy (IMRT) in 28 2.25 Gy fractions, 5 days/week, starts 3-5 weeks after the last dose of induction chemotherapy
16131726|NCT01921751|Drug|nab-Paclitaxel|125 mg/m2 weekly as a 30-40 minute infusion, three weeks on and 1 week [1 cycle = 4 weeks]
16131727|NCT01921738|Drug|1% Azithromycin gel|Participants received mechanical periodontal therapy, oral hygiene instructions and placement of the in-situ gel (0.2 ml 1% Azithromycin) into the periodontal pockets in single rooted teeth; twice with an interval of 20 minutes.
16131832|NCT01921036|Procedure|combined exercise|Moderate endurance and resistance exercise once a week over six months
16131728|NCT01921738|Drug|Azithromycin|Participants received mechanical periodontal therapy, oral hygiene instructions and antibiotic (Azithromycin 250mg x 6 capsules)
16131729|NCT01921738|Drug|placebo gel|Participants received mechanical periodontal therapy, oral hygiene instructions and placebo (antibiotic) in situ gel.
16131730|NCT01921738|Drug|placebo capsule|Participants received mechanical periodontal therapy (Scaling and Root Planing), oral hygiene instructions and placebo (antibiotic) capsules (250mg x 6), at mouth (Po), two times a day (bid) for three days.
16131731|NCT01921725|Device|hydrophilic-based dressing (KoCarbonTM)|"BCT Hydrophilic Wound Dressing consists of PET non-woven, activated carbon fiber (ACF) cloth and PE film. The PET non-woven is vapor permeable to allow air exchange for the wound. The absorbent ACF absorbs exudate, bacteria and odor to create an effective barrier. Furthermore, far infrared ray (FIR) emitted from ACF accelerates blood circulation and metabolism to reduce healing period. The PE film helps to minimize wound trauma at dressing changes."
16131732|NCT01921712|Drug|PUR0200|Randomized single doses of 3 selected doses of PUR0200, compared to a placebo and active comparator
16131733|NCT01921712|Drug|PUR0200 Placebo|Randomized, single dose of inhaled placebo matched to PUR0200
16131734|NCT01921712|Drug|Active comparator|Randomized single dose of inhaled active comparator product
16131735|NCT01921699|Procedure|taking blood samples from healthy people|
16131736|NCT01921686|Other|Sample collection and Questionnaire|This is an observational biospecimen collection and questionnaire study. The subjects will be asked to complete a symptom questionnaire at screening visit. In addition, 3 esophageal biopsy samples will be taken to conduct laboratory analyses.
16131737|NCT01921673|Drug|Dovitinib and docetaxel|"In phase I portion of the study Docetaxel 45-75 mg/m2, intravenous, every 3 weeks Dovitinib 200-500 mg, oral, 5 days on/2 days off
~In phase II portion of the study Recommended dose of docetaxel and dovitinib in phase I portion will be used."
16131738|NCT01921647|Drug|YH4808|
16131739|NCT01921647|Drug|Nexium|
16131740|NCT01921647|Drug|Amoxicillin|
16131741|NCT01921647|Drug|clarithromycin|
16131742|NCT01921634|Other|Modified Pathologic Analysis|
16131743|NCT01921621|Behavioral|Group B - Simulation Training|Group B resident training includes the use of a dry model shoulder simulator for practicing the steps and avoiding the errors of an arthroscopic Bankart repair
16131744|NCT01921621|Behavioral|Group C - Proficiency Based Progression|Group C - Proficiency Based Progression Group C residents must test to proficiency on the cognitive material contained in the orientation video, demonstrate arthroscopic knot tying proficiency to a pre-determined benchmark, and perform an arthroscopic Bankart repair on a dry shoulder simulator model to a pre-determined benchmark in order to progress in the training exercise
16131745|NCT01921608|Device|PrePex™ device|PrePex™ device for adult male circumcision programs. The PrePex™ device is designed to enable conducting male circumcision procedure that is bloodless with no anesthesia and no sutures.
16131746|NCT01921595|Other|Valanced salt colloid|Maximum dose : 30ml/kg, IV, The infusion of valanced salt colloid is started at bleeding and continued until reach at maximum dose
16131747|NCT01921595|Other|Valanced salt crystalloid group|Maximum dose : 30ml/kg, IV, The infusion of valanced salt crystalloid is started at bleeding and continued until reach at maximum dose
16131748|NCT01921582|Drug|Methylphenidate|"Weekly appointments with study psychiatrists for the first four weeks, and then biweekly appointments for the last eight weeks.
~Intervention will consist of medication as well as components of Med-Plus treatment (e.g., medication management, general support, and compliance enhancement strategies)."
16131749|NCT01921582|Behavioral|Cognitive Behavioral Therapy|"Cognitive Behavior Therapy will include three phases:
~Phase 1 undertakes to eliminate binge episodes and introduce a 'regular' pattern of eating;
~Phase 2 aims to reduce food intake and restructure eating-related cognitions;
~Phase 3 focuses upon relapse prevention"
16131750|NCT01921569|Behavioral|Standard of Care Therapy|Rest, ice, compression, elevation (RICE), NSAID or salicylate medication for pain, Physical Therapy and stretching exercises, Reduction in impact activities, to include an arm sling.
16131751|NCT01921569|Other|dHACM Injection|Injection into affected area with micronized dHACM suspended with total volume of 1 cc normal saline.
16131752|NCT01921569|Other|Normal Saline Injection|Injection into affected area with 1.0 cc normal saline solution instead of active agent.
16131753|NCT01921556|Behavioral|active comparator, QualiCCare education|"Physicians randomized into the intervention group get a QualiCCare training workshop designed to educate professionals on the guidelines but also and particularly governing professional behavior by feedback, reminders and pathways that help to change their attitudes and care behavior. Based on behavioral and learning theory, QualiCCare intervention not only tries to increase knowledge but also internal motivation and decision making by stimuli and resources and by written instruments that guide evidence based decision support."
16131754|NCT01921543|Device|ITP Stimulation|"Model 7428 Kinetra® Neurostimulator
~Model 3887 DBSTM Pisces Quad Compact Model 3389 DBSTM Brain Lead
~Model 3387 DBSTM Brain Lead
~Model 7482-51 Extension
~Model 7482-66 Extension
~Model 7482-95 Extension
~Model 7436 AccessTM Therapy Controller
~Model 3628 Dual Screener TM
~Model 8840 N'Vision"
16131755|NCT01921543|Device|CI/BNST stimulation|"Model 7428 Kinetra® Neurostimulator
~Model 3887 DBSTM Pisces Quad Compact Model 3389 DBSTM Brain Lead
~Model 3387 DBSTM Brain Lead
~Model 7482-51 Extension
~Model 7482-66 Extension
~Model 7482-95 Extension
~Model 7436 AccessTM Therapy Controller
~Model 3628 Dual Screener TM
~Model 8840 N'Vision"
16131756|NCT01921543|Device|No stimulation|
16131757|NCT01921530|Procedure|Interbody Fusion|The interbody fusion (IF) procedure requires exposure and removal of the disc, curetting the end plates, inserting a cage filled with bone graft, as well as stabilization with rods and screws.
16131758|NCT01921530|Procedure|Posterolateral Fusion|In posterolateral fusion stabilization is achieved using pedicle screws joined by rods. The graft used to facilitate fusion is placed between decorticated transverse processes and can be an autograft of iliac bone or local bone, allograft, or a synthetic expander.
16131759|NCT01921517|Device|Low Magnitude Mechanical Stimulation|Mechanical stimulation for 10 minutes daily for 12 months at a frequency of 30 Hz and acceleration of 0.3 g.
16131760|NCT01921517|Device|Sham Low Magnitude Mechanical Stimulation|Mechanical stimulation for 10 minutes daily for 12 months using a sham device.
16131833|NCT01921010|Drug|Niaspan|See Arm Description
16131834|NCT01921010|Drug|Placebo|See Arm Description
16131761|NCT01921504|Device|Acupuncture|"Acupuncture treatment
~Acupuncture rationale 1a) Style of acupuncture: body acupuncture (in accordance with meridian theory)
~Needling details 2a) Number of needle insertions per subject per session: 9-19 2b) Acupoints: Basic points - Large Intestine(LI)4, Stomach(ST)36, Liver(LR)3, Spleen(SP)4, Conception Vessel(CV)12 Optional points - Gallbladder(GB)21, Small Intestine(SI)14, Pericardium(PC)6, External points of Hand and Neck(EX-HN)5, Stomach(ST)34 2c) Depth: 5 ~ 30mm 2d) Response sought: 'Deqi' 2e) Needle stimulation: Manipulation 2f) Retention time: 15 minutes 2g) Needle type: 25 X 30 mm, sterilized stainless steel needle, Dongbang Inc., Korea"
16131762|NCT01921491|Procedure|Dressing Application|Application of a non-adherent dressing, a moisture retentive dressing, and a multi-layer compression dressing.
16131763|NCT01921491|Device|Offloading|"Provision of offloading cast walker or similar sponsor-approved device. May convert into instant total contact cast and/or add felt/foam to supplement offloading."
16131764|NCT01921452|Device|Quantitative POC TSH Kit|A drop (approximately 30 microliter [mcL]) of blood will be taken from subject's fingertip to test TSH quantitatively by using the quantitative POC TSH test kit according to the product specification on Day 1 to Day 5.
16131765|NCT01921452|Device|Qualitative POC TSH Kit|A drop (approximately 30 mcL) of blood will be taken from subject's fingertip to test TSH qualitatively by using the qualitative POC TSH test kit according to the product specification on Day 1 to Day 5.
16131766|NCT01921452|Device|Third generation TSH Kit|One milliliter (mL) of subject's venous blood will be taken to test both qualitative and quantitative TSH levels, by using the third generation TSH test kit on Day 1 to Day 5.
16131767|NCT01921439|Behavioral|Personalized Feedback|Personalized feedback reflecting the participant's current level of nicotine addiction, money spent on cigarettes, time spent smoking, and health effects of smoking.
16131768|NCT01921426|Drug|GC4419|GC4419 is a novel, highly stable manganese-containing macrocyclic ligand complex with a molecular weight of 483, whose activity mimics that of naturally occurring superoxide dismutase (SOD) enzymes. It is therefore a prototype of a new class of drugs termed selective SOD mimetics. GC4419 selectively removes superoxide anions without reacting with other reactive oxygen species, including nitric oxide, hydrogen peroxide, and peroxynitrite.
16131769|NCT01921413|Device|Urine Malaria Test|Rapid non-invasive malaria diagnostic test
16131770|NCT01921387|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo autologous PBSC transplant
16131771|NCT01921387|Drug|Carmustine|Given IV
16131772|NCT01921387|Drug|Cytarabine|Given IV
16131773|NCT01921387|Drug|Etoposide|Given IV
16131774|NCT01921387|Other|Laboratory Biomarker Analysis|Correlative studies
16131775|NCT01921387|Drug|Melphalan|Given IV
16131776|NCT01921387|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo autologous PBSC transplant
16131777|NCT01921387|Radiation|Yttrium Y 90 Anti-CD45 Monoclonal Antibody BC8|Given IV
16131778|NCT01921374|Biological|sleep parameters|Since the mother-caregiver dedicates herself entirely to her son, we will performe overnight polysomnography to assess the sleep pattern.
16131779|NCT01921374|Biological|Hormonal profile|To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters.
16131780|NCT01921374|Biological|Inflammatory profile|To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters
16131781|NCT01921374|Biological|Cardiovascular profile|To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters
16131782|NCT01921374|Biological|Metabolic profile|To assess the health profile of caregivers-mothers are analyzed some markers that may indicate an impairment or damage to the health of each of the parameters
16131783|NCT01921361|Drug|Levobupivacaine|Intrathecal 3ml (15 mg)
16131784|NCT01921361|Drug|Dexmedetomidine|Intrathecal 3 microgram (diluted 1/10, 0.3 ml)
16131785|NCT01921361|Drug|Dexmedetomidine|Intravenous 1ml/kg/10 minutes and than 0.5 ml/kg/hour infusion (dexmedetomidine diluted 1 microgram/ml)
16131786|NCT01921361|Drug|sodium chloride|Intravenous 1ml/kg/10 minutes and than 0.5 ml/kg/hour infusion in the control and intrathecal groups, intrathecal 0.3 ml in the control and intravenous groups.
16131787|NCT01921348|Device|acupressure pellets|The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis.
16131788|NCT01921348|Device|acupressure pellets|The sham group will have acupressure pellets placed in a pre-determined non-specific acupressure point on the ear that is not related to rhinitis.
16131789|NCT01921335|Drug|ARRY-380 Twice Daily Dosage|ARRY-380 will be administered daily (either twice-daily along with concurrent administration of trastuzumab on Day 1. PK sampling of ARRY-380 is planned on Day 15. Blood samples will be collected at pre-dosing, 2 hours (± 1 hour), and 6 hours (± 2 hours). The same time points will be collected for BID and QD schedules. On the PK collection day participants should fast one hour before and one hour after taking ARRY-380.
16131790|NCT01921335|Drug|ARRY-380 Once Daily|ARRY-380 will be administered daily once-daily) along with concurrent administration of trastuzumab on Day 1. PK sampling of ARRY-380 is planned on Day 15. Blood samples will be collected at pre-dosing, 2 hours (± 1 hour), and 6 hours (± 2 hours). The same time points will be collected for BID and QD schedules. On the PK collection day participants should fast one hour before and one hour after taking ARRY-380.
16131791|NCT01921335|Drug|Trastuzumab|6 mg/kg IV every 3 weeks
16131792|NCT01921322|Device|Pump|722 Paradigm Real-Time System
16131793|NCT01921322|Other|CGMS Gold|Device used to collect retrospective sensor data, blinded to the subjects, to compare to the treatment arm
16131794|NCT01921309|Device|Trinity CoC Total Hip System|total hip replacement with a ceramic femoral head which moves on a ceramic acetabular cup liner
16131795|NCT01921309|Device|Trinity Ceramic-on-Poly THR|total hip replacement with a ceramic femoral head which moves on a highly cross-linked ultra high molecular weight polyethylene acetabular cup liner
16131796|NCT01921296|Drug|Cyclobenzaprine|5 milligrams orally 2 hours before bedtime
16131830|NCT01921062|Behavioral|Motor imagery|The kinesthetic motor imagery training consists of the imagination of flexion, extension, abduction, adduction, pronation and supination of their injured wrist.
16131831|NCT01921036|Procedure|traditional cardiac rehabilitation|mutifactoral cardiac rehabilitation
16131797|NCT01921283|Device|BIS sensor attachment|For double blind method, BIS sensors were attached to all patients, but only BIS-group was measured by the value. BIS monitor was pushed back toward the anesthesiologist so that the physician could not see it. 3 L/min of oxygen was delivered by a nasal cannula to all patients throughout the procedure. Blood pressure was recorded every 5 minutes and heart rate, peripheral oxygen saturation were measured continuously. For induction of sedation, propofol 1 mg/Kg and lidocaine 30mg was administered throughout IV line and immediately followed by continuous infusion of propofol 0.04-0.06 mg/Kg/min and remifentanil 0.05 mcg/Kg/min. The evaluation of sedation depth using OAA/S was performed at 1 minute after propofol administration, endoscopy insertion, submucosal inflation by 1:100000 epinephrine with indigocarmine, initial submucosal dissection and when the patient had restlessness or coughing additively.
16131798|NCT01921283|Drug|no- BIS sensor attachment|
16131799|NCT01921270|Drug|Low Dose - AbobotulinumtoxinA|"Participants will receive low dose AbobotulinumtoxinA injections. Location of injections will be determined by the clinician to treat the individual's dystonic symptom.
~Muscles that may be included for in injection for OMD with Jaw Closing:
~Medial Pterygoid 50 units, Masseter 25 units
~Muscles that may be included in injection for OMD with Jaw Opening:
~Lateral Pterygoid 50 units, Anterior digastrics 10 units
~Muscle that will be included in injection for OMD with Tongue Protrusion:
~Genioglossus 7.5 units"
16131800|NCT01921257|Drug|Cat-PAD|
16131801|NCT01921257|Drug|Placebo|
16131802|NCT01921244|Other|Decision Aid|"Parents will receive an intervention modified from the previously published tool called Autism: Should My Child Take Medicine for Challenging Behavior? This packet provides parents with educational information, elicits parent ratings of particular behavioral domains, describes behaviors that are and are not amenable to medication treatment, and elicits parent preferences regarding treatment. Providers will be trained on use of the intervention in practice to promote shared decision making during clinical encounters."
16131803|NCT01921231|Drug|Hyperbaric Prilocaine 1%|Selective spinal anesthesia was performed on induction-block area and patient was transferred to the assigned operating room where another anesthesiologist (blinded for the arm) began to evaluate the blocking. Neither the nurse, surgeon nor the anesthesiologist involved in the patient evaluation knew the allocation group.
16131804|NCT01921231|Drug|Hyperbaric bupivacaine 0.5%|Selective spinal anesthesia was performed on induction-block area and patient was transferred to the assigned operating room where another anesthesiologist (blinded for the arm) began to evaluate the blocking. Neither the nurse, surgeon nor the anesthesiologist involved in the patient evaluation knew the allocation group.
16131805|NCT01921218|Drug|Belatacept|Belatacept, dosing 10mg/kg- day 0, 2 weeks, 1 month, 2 months, 3 months; subsequent doses 5mg/kg monthly through duration of trial or until retransplantation, whichever is first.
16131806|NCT01921218|Drug|Calcineurin inhibitor therapy|Upon enrollment, wean calcineurin inhibitor (CNI) to target tacrolimus trough of 3-5 nanogram/milliliter (ng/ml)or equivalent cyclosporine trough. Upon initiation of hemodialysis, discontinue CNI therapy over 5 days.
16131807|NCT01921218|Drug|Mycophenolate mofetil|Continue current dose at enrollment. Upon initiation of dialysis, decrease dose by half, then discontinue 2 weeks later
16131808|NCT01921218|Drug|prednisone|Begin steroid withdrawal one month after initiation of dialysis, with monthly reduction in dose by half, with plans to discontinue prednisone by 3 months after initiation of dialysis
16131809|NCT01921205|Drug|Lacosamide|"Subjects <30 kg (LCM oral solution): 4 mg/kg - 6 mg/kg BID ( 8mg/kg/day - 12 mg/kg/day)
~Subjects ≥30 kg to <50 kg (LCM oral solution): 3 mg/kg - 4 mg/kg BID (6 mg/kg/day - 8 mg/kg/day)
~Subjects ≥50 kg (LCM tablets): 150 mg - 200 mg BID (300 mg/day - 400 mg/day)"
16131810|NCT01921205|Other|Placebo|"Subjects <30 kg (placebo oral solution): 4 mg/kg - 6 mg/kg BID (8 mg/kg/day - 12 mg/kg/day)
~Subjects ≥30 kg to <50 kg (placebo oral solution): 3 mg/kg - 4 mg/kg BID (6 mg/kg/day - 8 mg/kg/day)
~Subjects ≥50 kg (placebo tablets): 150 mg - 200 mg BID (300 mg/day - 400 mg/day)"
16131811|NCT01921192|Drug|Folic Acid, vit B6 and B12|
16131812|NCT01921192|Drug|Placebo|
16131813|NCT01921179|Behavioral|GOALS (Goal-Oriented Attentional Regulation)|Goal-Oriented Attentional Regulation (GOALS) will involve 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of home practice). Some subjects will only receive the GOALS intervention.
16131814|NCT01921179|Behavioral|EDU (Brain Health Education)|Brain Health Education (EDU) will involve 5-weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of homework). The EDU intervention involves education on brain health and functioning in a classroom format, with study materials for homework. Some subjects will start with EDU and then cross-over to the GOALS.
16131815|NCT01921166|Drug|clomiphene plus gonadotropins|clomiphene plus gonadotropin ovulation induction
16131816|NCT01921166|Drug|Leuprolide flare|Leuprolide flare ovulation induction
16131817|NCT01921153|Other|Healthy meal plates and trays|The healthy meal plates and trays provide guidance for how to construct a meal in the military dining facility.
16131818|NCT01921140|Drug|Olaparib tablets|Olaparib dosing (2X 150mg tablets) following allocated meal
16131819|NCT01921140|Procedure|Pharmacokinetic sampling|Blood samples taken pre and post dosing with 2x 150 mg olaparib tablet
16131820|NCT01921140|Other|Dietary Fasted|2x 150 mg olaparib tablet formulation taken in fasted state. 5-14 days washout period
16131821|NCT01921140|Other|Dietary High Fat|2x 150 mg olaparib tablet formulation taken 30 minutes after allocated meal. 5-14 days washout period.
16131822|NCT01921114|Device|BioFlo™ Peripherally Inserted Central Catheter (PICC)|
16131823|NCT01921114|Device|Bard® Dual-Lumen PowerPICC SOLO2®|
16131824|NCT01921101|Behavioral|intensive medical nutrition|provision of participants energy and protein needs via enteral, parenteral nutrition from hospital admission to discharge
16131825|NCT01921101|Other|control|participants will receive standard care for nutrition received from hospital admission to discharge
16131826|NCT01921088|Other|real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF)|Subjects are provided with RT-fMRI-NF.
16131827|NCT01921088|Behavioral|Ambulatory Training|Subjects are provided with an ambulatory training.
16131828|NCT01921075|Other|normal dietary behavior|normal dietary behavior during examination days
16131835|NCT01920984|Drug|intravitreal injection of 1.25 mg of bevacizumab|Patients will receive intravitreal injection of 1.25 mg of bevacizumab (0.05 ml) 7 to 9 days before vitrectomy
16131836|NCT01920971|Radiation|infrared therapy|wavelength = 890 nm, radiant power output = 6.24 W, power density = 34.7 milliWatts/cm2 for 40 min, total energy 83.2 J/cm2
16131837|NCT01920958|Other|TachoSil®|TachoSil® is a collagen sponge that is coated with the active substances human fibrinogen and human thrombin and that supports hemostasis and tissue sealing in surgery.
16131838|NCT01920945|Drug|OnabotulinumtoxinA|155 units of OnabotulinumtoxinA, will be injected into 31 sites in the head and neck every 12 weeks for a total of 24 weeks using a sterile 30-gauge, 0.5 inch needle as 0.1 mL (5 Units) injections per each site. Injections will be divided across seven specific head/neck muscle areas (corrugator, procerus, frontalis, temporalis, suboccipital, splenius capitus and medial/lateral occipital, and trapezius).
16131839|NCT01920932|Drug|brentuximab vedotin|Given intravenously (IV).
16131840|NCT01920932|Drug|etoposide|Given IV.
16131841|NCT01920932|Drug|prednisone|Given orally (PO).
16131842|NCT01920932|Drug|doxorubicin|Given IV.
16131843|NCT01920932|Drug|cyclophosphamide|Given IV.
16131844|NCT01920932|Drug|Dacarbazine(R)|Given IV.
16131845|NCT01920932|Drug|filgrastim|Given subcutaneously (SQ) as clinically indicated.
16131846|NCT01920932|Other|quality of life assessment|Quality of life assessment will be done at initial clinical visit, and during chemotherapy, completion of therapy, then at 1 year, 2 years and 5 years. It should take no more than 15-20 minutes to complete. Participation is voluntary by participating institution and by participant.
16131847|NCT01920932|Radiation|radiation therapy|At the end of chemotherapy and recovery of blood counts, radiotherapy will be given to any involved nodes (if any) that are not in complete remission.
16131848|NCT01920919|Drug|Dexamethasone|
16131849|NCT01920919|Drug|Placebo|
16131850|NCT01920906|Procedure|Skin biopsy and blood test|Analysis of histology and gene expression in affected and unaffected skin
16131851|NCT01920893|Drug|Placebo (for dupilumab)|Solution for injection; Subcutaneous injection.
16131852|NCT01920893|Drug|Dupilumab|Solution for injection; Subcutaneous injection.
16131853|NCT01920893|Drug|Mometasone furoate nasal spray|Nasal spray, 2 actuations in each nostril twice daily.
16131854|NCT01920880|Other|Quantitative Sensory Testing analysis|
16131855|NCT01920867|Procedure|RB (Retrobulbar)|Retrobulbar injection of Bone Marrow Derived Stem Cells (BMSC)
16131856|NCT01920867|Procedure|ST (Subtenon)|Subtenon injection of Bone Marrow Derived Stem Cells (BMSC)
16131857|NCT01920867|Procedure|IV (Intravenous)|Intravenous injection of Bone Marrow Derived Stem Cells (BMSC)
16131858|NCT01920867|Procedure|IVIT (Intravitreal)|Intravitreal injection of Bone Marrow Derived Stem Cells (BMSC)
16131859|NCT01920867|Procedure|IO (Intraocular)|Intraocular injection of Bone Marrow Derived Stem Cells (BMSC) with vitrectomy prior to intraocular injection. For example, may include larger amount of stem cells in the intravitreal cavity, intraneuronal injections or subretinal injections of stem cells.
16131860|NCT01920854|Drug|soluble ferric pyrophosphate|
16131861|NCT01920854|Drug|Placebo|
16131862|NCT01920841|Other|Cream A applied to left thigh and Cream B to right thigh|Half the participants will receive Cream A applied to the left thigh, and Cream B applied to the right thigh
16131863|NCT01920841|Other|Cream B applied to left thigh and Cream A to right thigh|Half the participants will receive Cream B applied to the left thigh and Cream A applied to the right thigh
16131864|NCT01920815|Other|No interventions|
16131865|NCT01920802|Drug|olanzapine|5mg BID up to 4 weeks
16131866|NCT01920802|Drug|iloperidone|6 mg BID up to 4 weeks
16131867|NCT01920802|Drug|Placebo|BID up to 4 weeks
16131868|NCT01920789|Radiation|Stereotactic radiotherapy|Margin between CTV and PTV of 5 mm in transversal direction (except for small targets (<3cm) not fixed to thoracic wall or mediastinal structures, where margin should be 10 mm) and 10 mm in longitudinal direction. Planned heterogeneous dose distribution within the PTV with about 50% higher dose to the center compared to the periphery. Hypofractionation with 22 Gy times 3 at the isocenter (15 Gy at the periphery of the PTV)during one week will be used.
16131869|NCT01920789|Radiation|Conventionally fractionated radiotherapy|Clinical target volume (CTV) comprises the Gross Tumor Volume (GTV), including its diffuse growth at the borders. Planning target volume (PTV) is defined as the CTV with a total margin of 2 cm in all directions. The patient will receive 35 fractions, with a dose of 2.0 Gy/fraction at the ICRU reference point to a total dose of 70 Gy. The treatments will be given five days a week. The total treatment time should be as close to seven weeks as possible. The aim is that the dose distribution should be as homogeneous as possible.
16131870|NCT01920776|Other|ultrasound examination|
16131871|NCT01920776|Other|Ultrasound group|Ultrasound group will receive ultrasound examination at least once a day, the results will be noted to the attending who is in charge of the treatment.
16131872|NCT01920763|Other|Clinical Measurement|No direct interventions; study is observational and clinical assessments only will be performed.
16131873|NCT01920750|Biological|MLCwA|Antigen MLSA-LAM is a pellet extracted 3x followed by removal of SDS by column chromatography. Contains many of the same proteins
16131874|NCT01920750|Biological|MLSA-LAM|Antigen MLSA-LAM is derived from M. leprae extract following sonication and centrifugation, leaving the cytosol (MLSA). Contains soluble protein antigens of M. leprae
16131875|NCT01920750|Other|Mock Antigen|Physiological saline
16131876|NCT01920737|Drug|Daunorubicin|In the event of a shortage of daunorubicin, doxorubicin may be used as a substitute.
16131877|NCT01920737|Drug|Vincristine|
16131878|NCT01920737|Drug|Prednisone|
16131879|NCT01920737|Drug|PEG-Asparaginase|
16131880|NCT01920737|Drug|Methotrexate|
16131881|NCT01920737|Drug|6-MP (6-Mercaptopurine)|
16131882|NCT01920737|Drug|Cyclophosphamide|
16131883|NCT01920737|Drug|Cytarabine|
16131884|NCT01920737|Drug|Leucovorin|
16131885|NCT01920737|Drug|Dexamethasone|
16131886|NCT01920737|Other|Blood draw|
16131887|NCT01920737|Device|CT/PET scans|PET or CT scan every 6 months for 3 years
16131888|NCT01920711|Drug|LCZ696|LCZ696 50mg, 100mg and 200 mg dosage strengths will be available for dose adjustments.
16131889|NCT01920711|Drug|Valsartan|Valsartan 40mg, 80mg and 160mg dosage strengths will be available for dose adjustments.
16131890|NCT01920698|Device|Percutaneous MitraClip Device Implantation|MitraClip System includes a MitraClip device, a steerable guide catheter and a MitraClip delivery system
16131891|NCT01920698|Other|control|
16131892|NCT01920685|Other|Anxiety intervention|
16131893|NCT01920672|Behavioral|Timed Planned Activity|
16131894|NCT01920672|Behavioral|Home Safety and Education Program|
16131895|NCT01920659|Behavioral|High Intensity Training (HIT)|6 weeks of HIT, 3 times a week (3-5 1min on/off)
16131896|NCT01920659|Behavioral|REHIT|6 weeks 3 x week (20sec intervals)
16131897|NCT01920646|Other|ALV|Random allocation of children of two rural farm schools per grade to receive either 300 gram cooked ALVs and school meal starch or the normal school meal as daily meal (5 days/weeks) for 3 months.
16131898|NCT01920620|Behavioral|Inpatient weight loss counseling|Weight loss counseling utilizing a 13 minute patient education video on weight loss and an 25 minute personalized health education session. Subjects set 3 specific behavior set three specific lifestyle goals prior to discharge including a calculated six month weight loss goal (10% of body weight) and specific dietary and fitness goals. Usual care group participants received no specific instruction regarding weight loss prior to discharge.
16131899|NCT01920620|Behavioral|Motivational interviewing and troubleshooting via phone|All subjects were asked to track their weights over the 6 month duration of the study. Weights were obtained by phone at weeks 1,2,3,4, 8, 12, 16, 20 and 24. Phone calls for the intervention group utilized motivational and troubleshooting techniques whereas calls in the usual care group were used only to obtain weight and assess for changes in medications or health condition.
16131900|NCT01920607|Device|magnetic anal sphincter|
16131901|NCT01920607|Device|sacral nerve stimulation|
16131902|NCT01920594|Drug|GSK1278863|White, round biconvex, film coated tablet with unit dose strength of 100 mg for oral administration
16131903|NCT01920594|Drug|Placebo|White, round biconvex, film coated GSK1278863 matching placebo tablet for oral administration
16131904|NCT01920568|Biological|Denosumab 70 mg/mL|Denosumab will be given as a SC injection of 120 mg by administering a 1.7 mL volume in a single injection
16131905|NCT01920568|Drug|Zoledronic acid 4 mg|Zoledronic acid 4 mg (or equivalent clearance-adjusted dose in subjects with baseline creatinine clearance <=60 ml/min) will be diluted in either 0.9% sodium chloride or 5% dextrose injection and administered IV.
16131906|NCT01920568|Drug|Placebo IV|The placebo will consist of 1.7 mL 0.9% w/v sodium chloride
16131907|NCT01920568|Drug|Placebo SC|The placebo will consist of either 0.9% w/v sodium chloride or 5% dextrose injection
16131908|NCT01920568|Dietary Supplement|Calcium supplement|Subjects are strongly recommended to take daily supplements of at least 500 mg calcium from the day of consent and until completion of the Week 73 follow-up visit.
16131909|NCT01920568|Dietary Supplement|Vitamin D supplement|Subjects are strongly recommended to take daily supplements of at least 400 IU of vitamin D from the day of consent and until completion of the Week 73 follow-up visit.
16131910|NCT01920555|Drug|Ketamine|Dose of Ketamine will be 0.1 mg/kg - one single infusion
16131911|NCT01920555|Drug|Ketamine|Dose of Ketamine will be 0.2 mg/kg - one single infusion
16131912|NCT01920555|Drug|Ketamine|Dose of Ketamine will be 0.5 mg/kg - one single infusion
16131913|NCT01920555|Drug|Ketamine|Dose of Ketamine will be 1.0 mg/kg - one single infusion
16131914|NCT01920555|Drug|Placebo Midazolam|Dose of Midazolam (active placebo) will be 0.045 mg/kg - one single infusion
16131915|NCT01920542|Drug|Dexmedetomidine|administration of dexmedetomidine on dexemedetomidine group
16131916|NCT01920542|Drug|no dexmedetomidine|no administration of dexmedetomidine on control group
16131917|NCT01920529|Other|aerobic exercise|Performed aerobic exercise on a treadmill with cardiac predetermined frequency within 6 weeks and frequency of three times per week. All patients were monitored during training.
16131918|NCT01920516|Drug|Melphalan|Melphalan 1mg/kgr is rapidly infused into the isolated limb via the arterial catheter after the inflation of venous baloon catheter.
16131919|NCT01920503|Drug|Doxorubicin|Doxorubicina is loaded at the concentration of 50-75 mg/mq onto 2 ml of 70-150 µm M1 microspheres and is infused by TACE method
16131920|NCT01920490|Device|GUILT-INCREASE-CORRELATION|"This uses a novel software FRIEND created at IDOR in Rio de Janeiro, Brazil. The software is used on a regular clinical fMRI scanner"
16131921|NCT01920490|Device|GUILT-STABILIZE-CORRELATION|"This uses a novel software FRIEND created at IDOR in Rio de Janeiro, Brazil. The software is used on a regular clinical fMRI scanner"
16131922|NCT01920477|Biological|Ofatumumab|Ofatumumab (human monoclonal antibody) was provided in prefilled glass syringes initial syringes contained 0.6ml (60mg) of concentration 100 mg/m: drug product subsequently modified to 0.4 mL (20mg) concentration (50mg/ML) drug product
16131923|NCT01920477|Biological|Placebo|Placebo to match the active doses will consist of prefilled glass syringes filled with normal saline.
16131924|NCT01920451|Behavioral|Cognitive-Behavioral Therapy for Insomnia (CBTI)|See arm description.
16131925|NCT01920438|Procedure|Percutaneous Endoscopic Gastrostomy|PEG
16131926|NCT01920438|Procedure|Radiologically-guided insertion of Gastrostomy|RIG
16131927|NCT01920425|Device|Kinesia HomeView|Motion sensor based telemedicine system for assessment of movement disorder motor symptoms in the home. Includes automated motor assessment using motion sensor and electronic dyskinesia diary.
16131928|NCT01920425|Other|Hand-written diary|Hand-written paper diary indicating state (Off, On without dyskinesias, on with non-troublesome dyskinesias, on with troublesome dyskinesias) at 30 minute intervals.
16131929|NCT01920412|Device|LAmbre Left Atrial Appendage(LAA) Occluder|Implanting the LAmbre Left Atrial Appendage Occluder to close the left atrial appendage
16131930|NCT01920399|Drug|CAZ-AVI|A single 120 minute IV infusion on Day 1, followed by three times daily (every 8 hours, q8h) as 120 minute IV infusions for 7 days (Day 2 to Day 8), and one single 120 minute IV infusion on Day 9.
16131931|NCT01920399|Drug|0.9% Normal Saline|A single 120 minute IV infusion on Day 1, followed by three times daily (every 8 hours, q8h) as 120 minute IV infusions for 7 days (Day 2 to Day 8), and one single 120 minute IV infusion on Day 9.
16131932|NCT01920386|Drug|Tramadol hydrochloride/Acetaminophen Tab.|
16131933|NCT01920386|Drug|Tramadol hydrochloride/Acetaminophen SR Tab.|
16131934|NCT01920373|Drug|Group A (corticosteroid injection group)|
16131935|NCT01920373|Biological|Group B (platelet rich plasma injection group)|
16131936|NCT01920360|Other|SULPHUROUS WATERS IMMERSION BATHS|SULPHUROUS WATERS IMMERSION BATHS: The baths will be held in individual tubs, properly disinfected, supplied with sulphurous thermal water at a temperature 37-39 ° C, which encompass the optimum temperatures for therapeutic bath. The baths lasted for 20 minutes. The subjects will drink two cups of water, 300 ml before and after the baths, in order to avoid an imbalance water.
16131937|NCT01920360|Other|NOT SULPHUROUS WATERS IMMERSION BATHS|NOT SULPHUROUS WATERS IMMERSION BATHS:The baths will be held in individual tubs, properly disinfected, supplied with not sulphur thermal water at a temperature 37-39 ° C, which encompass the optimum temperatures for therapeutic bath. The baths lasted for 20 minutes. The subjects will drink two cups of water, 300 ml before and after the baths, in order to avoid an imbalance water.
16131938|NCT01920360|Other|CONTROL GROUP|CONTROL GROUP: This group did not receive any treatment, only received some verbal directions as to the care that should be taken to prevent and control the knee pain.
16131939|NCT01920334|Drug|Zolpidem CR 12.5mg|Patients will be given zolpidem CR 12.5mg each night for, at least, 3 consecutive nights, including the first night on the Cardiac ICU, when the undergo a full-night polysomnography
16131940|NCT01920334|Drug|Placebo|Patients will receive placebo pills at night, according to their usual sleep time, from the first night on the Cardiac ICU, until their hospital discharge
16131941|NCT01920321|Procedure|Endoscopic lung volume reduction|Prior the procedure patients undergo - high resolution chest CT , extensive phisiological assessment.
16131942|NCT01920308|Device|5 mm Bard LifeStent Vascular Stent|The LifeStent® Vascular Stent is a peripheral stent intended to improve luminal diameter in the treatment of symptomatic de-novo or restenotic lesions up to 240 mm in length in the native superficial femoral artery (SFA) and popliteal artery with reference vessel diameters ranging from 4.0 - 6.5 mm.
16131943|NCT01920295|Device|Cryoballoon ablation|
16131944|NCT01920282|Drug|Nebivolol|
16131945|NCT01920282|Other|Lifestyle Modification|
16131946|NCT01920282|Other|Nebivolol plus Lifestyle Modification|
16131947|NCT01920269|Procedure|Trans-urethral resection|Patients underwent urinary cytology of the bladder and upper urinary tract; random cold-cup biopsies of the bladder and prostatic urethra, and complete transurethral resection of all bladder tumour visible on endoscopy, ensuring muscle is included in resected samples.
16131948|NCT01920269|Drug|intravesical passive diffusion mitomycin|A dose of 40 mg mitomycin dissolved in 50 ml sterile water is infused intravesically through a Foley catheter, retained in the bladder for 60 min with catheter clamping, and then drained. Patients who have a complete response to the initial 6 weekly treatments underwent a further 10 monthly instillations, with the same dose and methods of infusion as initial assigned treatment.
16131949|NCT01920269|Device|intravesical electromotive mitomycin|A dose of 40 mg mitomycin dissolved in 100 ml water is instilled and retained in the bladder for 30 minutes with 20 mA pulsed electric current, and then drained. Patients who have a complete response to the initial 6 weekly treatments underwent a further 10 monthly instillations with the same dose and methods of infusion as initial assigned treatment. Intravesical electromotive drug administration is given by a battery-powered generator delivering a controlled electric current that passes between the active intravesical electrode (integrated into a specific transurethral catheter) and dispersive ground electrodes (on skin of the lower abdomen). Operators set active electrode polarity and current intensity on the generator.
16131950|NCT01920256|Other|Remote, personalized type 2 diabetes care.|Diabetes and comorbidities will be managed with 1 clinic visit per year and frequent adjustments made remotely.
16131951|NCT01920256|Other|Usual Endocrine care.|Diabetes and comorbidities management will provided by an endocrinologist
16131952|NCT01920243|Behavioral|Health Mechanics Program|The intervention will consist of six modules that will address attitudes, self-monitoring, communication and organizational skills, problem solving skills and stress management as presented through the Health Mechanics program. These modules are designed to take place over 6 phone calls of approximately 45 minutes each. In order to provide flexibility for the participants, the quantity and duration of calls may vary depending on the extent that the participant completes the homework and the amount of time they need to learn the skill.
16131953|NCT01920230|Behavioral|Mindfulness-ACT-intervention|Half of the participants (n=109) is assigned to intervention group. The intervention is based on Mindfulness-program presented by Williams & Penman (2011) and on principles of acceptance-commitment therapy (ACT). It aims to increase mindfulness skills and psychological flexibility through different exercises that are developed for improving skills of being present, dealing with thoughts and feelings as well as support clarifying individual values and value-based actions. The basic principles are presented in weekly small group meetings. Participants are guided to deepen their experiences through exercises and information that is provided via specific web-site.
16131954|NCT01920230|Behavioral|No intervention|Half of the participants (n=109) don't get any special treatment. However the present study explores what kind of support they have had during the program.
16131955|NCT01920204|Drug|Midostaurin,|Midostaurin, twice daily 100 mg orally, continuously for 6 months
16131956|NCT01920191|Biological|IMA 950|
16131957|NCT01920191|Biological|Poly ICLC|
16131958|NCT01920191|Other|Immunomonitoring|Blood samples, DTH analysis
16131959|NCT01920178|Device|PinPointe Foot Laser|Active Laser Treatment Group will receive active Pinpointe Foot Laser beam. Control Placebo Sham Laser Group will receive only the localizing (aiming) non-active beam of the Pinpointe Foot Laser
16131960|NCT01920165|Other|Smoke-free legislation|The intervention under study is the smoke-free legislation in England introduced overnight on 1 July 2007. As of this date virtually all enclosed public places and workplaces are by law required to be smoke-free. More detail can be found at: http://www.smokefreeengland.co.uk
16131961|NCT01920152|Biological|PRP|Each PRP preparation requires a total of 36 ml of peripheral blood. This will be obtained via venapuncture and collected in four 9 ml extraction tubes containing 3.8% sodium citrate. The tubes are then centrifuged at 640 rpm for 8 minutes at room temperature. The 1ml plasma fraction located above the buffy coat is aspirated from each tube and dispensed into the fractioning tube. The entire PRP process takes place under laminar airflow. Immediately prior to injection, calcium chloride is is drawn up from the activator ampoule with the activation syringe and is added to the PRP fractioning tube. The activated PRP is then injected in its entirety into the hip joint under strict aseptic technique.
16131962|NCT01920152|Device|Hyaluronic Acid|Hyaluronic acid is supplied as a non-pyrogenic solution in 2.5 ml pre-filled syringes and is administered by intra-articular injection using a 22-23 gauge needle. The full 2.5 ml is injected in one joint under strict aseptic administration.
16131963|NCT01920139|Procedure|Fine needle aspiration and core biopsy of lymph node|Ultrasound guided fine needle aspiration of an abnormal lymph node followed by ultrasound guided core biopsy of the same node followed by clip placement into the node.
16131964|NCT01920139|Procedure|Axillary surgery|Patients underwent axillary node dissection or excision of setinel axillary nodes at the time of surgical treatment of their breast cancer.
16131965|NCT01920139|Other|Titanium marker|A titanium marker was deposited into the lymph node that was percutaneously biopsied , immediately after the last tissue sample obtained.
16131966|NCT01920126|Drug|sodium bicarbonate|0.5 mmol/kg for 1 hr, and then 0.15 mmol/kg/h for 23 hrs The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery
16131967|NCT01920126|Drug|Saline|
16131968|NCT01920113|Drug|Dexmedetomidine - remifentanil group|
16131969|NCT01920113|Drug|Propofol - remifentanil group|
16131970|NCT01920087|Drug|ATNC05|Subject will take between two and four capsules of study medication per day, according to the dose titration schedule in the protocol.
16131971|NCT01920087|Drug|Placebo|Subject will take between two and four capsules of study medication per day, according to the dose titration schedule in the protocol.
16131972|NCT01920074|Drug|Nitroglycerin Ointment 0.4%|
16131973|NCT01920061|Drug|PF-05212384 (gedatolisib)|PF-05212384 weekly intravenous infusions starting at 90 mg/wk as a 3 week cycle
16131974|NCT01920061|Drug|Docetaxel|Docetaxel intravenous infusions once every 3 weeks starting at 75 mg/m^2
16131975|NCT01920061|Drug|Cisplatin|Cisplatin intravenous infusions once every 3 weeks starting at 75 mg/m^2
16131976|NCT01920061|Drug|Dacomitinib|Dacomitinib to be taken orally as a continuous once daily regimen at a starting dose of 30 mg
16131977|NCT01920048|Procedure|Percutaneous Coronary Intervention|
16131978|NCT01920048|Drug|Drug Therapy for Heart Failure|The optimal combination of drugs and doses for each patient will be individualized and will be determined by his/her physician, in accordance with local and international clinical practice guidelines
16131979|NCT01920048|Device|Device Therapy for Heart Failure|The optimal device therapy for each patient will be individualized and will be determined by his/her physician, in accordance with local and international clinical practice guidelines. In most cases the device will be an Implantable Cardioverter Defibrillator and/or Cardiac Resynchronization Therapy.
16131980|NCT01920035|Device|UroCool (Local cooling/hypothermia)|These patients will receive the UroCool device which will be inserted just prior to RARP surgery. The UroCool device will be used to effect localized cooling/hypothermia of the pelvic region prior to and during RARP surgery. It will be removed at the end of surgery.
16131981|NCT01920022|Drug|Mifepristone|Day one of medical abortion
16131982|NCT01920022|Drug|etonorgestrel|
16131983|NCT01920009|Behavioral|Pharmacist counselling session with a motivational interview|"The intervention:
~The patient will be invited by the community pharmacist for two consultations the first 2 weeks after discharge and the second after 3 months.
~The intervention group consultation:
~Community pharmacy consultation around 2 weeks The consultation will take place in the pharmacy a face to face consultation for 20 minutes including; Motivational interview session, the pharmacists will incorporate the key motivational interview skills in their consultation Express empathy, develop discrepancy, role with resistance, support self efficacy.
~The sessions will aim to develop a partnership between the pharmacist with the patient and exchange information to facilitate an informed decision. Furthermore both the pharmacist and the patient will negotiate behaviour and reach an agreement. The goal is to access motivation and elicit commitment to change behaviour in this case would be adherence to life saving medication"
16131984|NCT01919996|Drug|Azithromycin|Azithromycin oral suspension (immediate release) 12 mg/kg/day x 5 days
16131985|NCT01919970|Other|Cognitive Behavioral Therapy|This condition involves 12 weekly CBT sessions.
16131986|NCT01919970|Other|Treatment as usual|This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them.
16131987|NCT01919957|Other|No intervention|
16131988|NCT01919944|Drug|VLY-686|capsules containing either 10 mg or 50 mg VLY-686
16131989|NCT01919944|Drug|Placebo|Sugar capsule to mimic either VLY-686 10 mg capsule or 50 mg capsule
16131990|NCT01919918|Drug|Muscle Contraction with Metabolite Solution Administration|Participants will perform maximal elbow flexor or knee extensor contractions before and after administration of metabolite solutions of pH 7.2, pH 7.0 and pH 6.6
16131991|NCT01919905|Dietary Supplement|Vitamin D|High dose group receive 28000 IU vitamin D once a week Low dose group receive 200 IU vitamin D once a week
16131992|NCT01919892|Drug|Lithium|
16131993|NCT01919879|Drug|Cetuximab + Afatinib|Afatinib taken orally, cetuximab administered intravenously
16131994|NCT01919879|Drug|Cetuximab|Cetuximab administered intravenously
16131995|NCT01919866|Other|Transplantation of CD3/CD19 depleted stem cells|
16131996|NCT01919853|Behavioral|Mindfulness-Based Stress Reduction|
16131997|NCT01919853|Behavioral|Attention Control|
16131998|NCT01919840|Procedure|Group ROTEM|"10 min after administration of protamine, if there is a large diffuse microvascular bleeding or bleed excessively at the exit of surgery then will check an Intem, a Heptem a Extem and Fibtem.
~If any of the determinations altered and the patient leaves still bleeding apply the proposed treatment algorithm for Rotem. 10 minutes after each treatment will take the test again indicated that treatment, to ensure that the defect has been corrected."
16131999|NCT01919840|Other|Group C|"10 min. after protamine administration, if there is a significant diffuse microvascular bleeding or when the patient departure from surgery if bleeds excessively will be a TCA and routed the following analytical results: prothrombin time, activated partial thromboplastin time, platelet count and fibrinogen.
~If any of the determinations altered and the patient still bleeding, apply the standard protocol of the unit. 10 minutes after each treatment was performed new laboratory tests to analyze the result."
16132000|NCT01919827|Biological|Endobronchial infusion of adult mesenchymal stem cells|
16132001|NCT01919827|Biological|Autologous mesenchymal stem cells derived from bone marrow|
16132002|NCT01919814|Dietary Supplement|Appethyl™|Four hours after breakfast participants will be given a small amount of liquid to drink that will contain Appethyl™. They will not know which they are getting and it will be decided randomly, like flipping a coin. Participants will be presented with a pizza in a quantity more than they could reasonably be expected to eat 5 hours after the start of their lunch meal and be asked to eat to their satisfaction over 30 minutes. Participants are not expected to eat all of the pizza.
16132003|NCT01919814|Other|Placebo|Four hours after breakfast, participants will be given a small amount of liquid to drink that will contain a placebo (inactive liquid). Participants will not know which they are getting and it will be decided randomly, like flipping a coin. Participants will be presented with a pizza in a quantity more than they could reasonably be expected to eat 5 hours after the start of their lunch meal and be asked to eat to their satisfaction over 30 minutes. They are not expected to eat all of the pizza.
16132004|NCT01919801|Drug|Icatibant|Single dose of 30 mg icatibant administered within 12 hours of the onset of an acute attack of ACE-I-induced angioedema
16132005|NCT01919801|Drug|Placebo|
16132006|NCT01919788|Drug|Insulin (Insuman Rapid)|
16132007|NCT01919788|Drug|Glucose|
16132008|NCT01919788|Other|Saline|
16132009|NCT01919749|Other|treated recommended|Treatment will be recommended after reviewing the profiling analysis
16132010|NCT01919736|Behavioral|Gait Retraining|
16132011|NCT01919723|Drug|Ticagrelor|Ticagrelor loading dose
16132012|NCT01919723|Drug|Eptifibatide|i.v. infusion
16132013|NCT01919710|Drug|rHSA/GCSF|for treatment of neutropenia
16132014|NCT01919697|Drug|Plecanatide|
16132015|NCT01919684|Drug|LGD-6972|
16132016|NCT01919684|Drug|Placebo (Captisol®)|
16132017|NCT01919671|Drug|Tongxinluo capsule|for 90 days
16132018|NCT01919671|Drug|placebo capsule|for 90 days
16132019|NCT01919658|Procedure|nerve block|A nerve block performed as per standard of care: femoral nerve blocks, and saphenous nerve blocks performed more distally (within 10cm superior to the adductor tubercle).
16132020|NCT01919645|Other|Combined Training ( Strength + Aerobics)|Strength training performed using workout devices and aerobic training performed using stationary bicycle.
16132021|NCT01919632|Behavioral|health-behavior seminar and endurance exercise|The initial stage of the program consists of a health-behavior seminar and six weeks (twice a week for 90 minutes) of supervised endurance exercise (i.e. jogging, nordic walking, cycling or swimming) in groups. In the second phase of the program, the participants receive a recommendation to continue exercise regularly unsupervised for one year, and receive monthly supervised exercise training sessions.
16132022|NCT01919619|Biological|Ipilimumab|Given IV
16132023|NCT01919619|Drug|Lenalidomide|Given PO
16132024|NCT01919606|Drug|EXPAREL|Single-dose EXPAREL diluted with 20 mL or 40 mL saline to a volume of 40 mL or 60 mL, respectively.
16132025|NCT01919593|Drug|2% chlorhexidine gluconate in 70% alcohol|skin preparation before venipuncture for blood culture in even month
16132026|NCT01919593|Drug|10%povidone iodine|skin preparation before venipuncture for blood culture in odd month
16132027|NCT01919554|Biological|SLIT tablets of HDM allergen extracts|
16132028|NCT01919541|Other|Prehabilitation|All patients will receive a prehabilitation program, which involves a personalized exercise component provided by a kinesiologist.
16132029|NCT01919541|Device|hyperinsulinemic euglycemic isoaminoacid clamp|A hyperinsulinemic euglycemic isoaminoacid clamp followed by a hyperinsulinemic euglycemic hyperaminoacid clamp performed at baseline and immediately before surgery will provide insight into insulin resistance of glucose and protein metabolism in colorectal cancer patients pre- and post-intervention. Similarly, simultaneous infusions of leucine and glucose stable isotopes will provide insight into baseline and interventional effects of the program on whole body leucine and glucose kinetics.
16132030|NCT01919541|Device|hyperinsulinemic euglycemic hyperaminoacid clamp|
16132031|NCT01919541|Dietary Supplement|whey protein supplementation|
16132032|NCT01919541|Other|Prehabilitation|All patients will receive nutrition guidance and a nutrition component with whey protein supplementation.
16132033|NCT01919528|Procedure|ultrasound|catheterization of the axillary vein under ultrasound guidance
16132034|NCT01919515|Device|ZR Crown|This is an esthetic primary molar crown.
16132035|NCT01919515|Device|Stainless Steel Crown|This is a conventional stainless steel crown.
16132036|NCT01919502|Device|Semi-quantitative urine pregnancy test|
16132037|NCT01919489|Drug|Liraglutide + OADs|Liraglutide subcutaneously daily
16132038|NCT01919489|Drug|Glargine + OADs|Glargine once daily subcutaneously
16132039|NCT01919476|Other|Bagel|
16132040|NCT01919476|Other|Cream Cheese|
16132041|NCT01919476|Other|Almond Butter|
16132042|NCT01919463|Behavioral|Abdominal Compression|Abdominal Compression is conducted by GI assistants during intubation process to facilitate the process. It can be conducted at different ares of the abdomen with different force.
16132043|NCT01919463|Device|Guidance of Magnetic Endoscopic Imaging (MEI) System|Live image of MEI can show the form of the colonoscope inside the body. Live image is show to colonoscopist for facilitating the intubation process.
16132044|NCT01919450|Drug|Regadenoson|Subjects will undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
16132045|NCT01919450|Radiation|Rubidium-82|Subjects undergo a rest/Lexiscan (regadenoson) stress myocardial perfusion PET study.
16132046|NCT01919437|Device|Web-Enabled Cognitive Neuropsychological Evaluation System|
16132047|NCT01919424|Drug|Methacholine Chloride|"Choline ester that acts as a non-selective muscarinic receptor agonist in the parasympathetic nervous system
~Low risk - commonly used to diagnose asthma"
16132048|NCT01919424|Device|Trudell AeroEclipse*II BAN nebulizer|Generates aerosol after a certain inspiratory flow has been reached and then stops nebulization the moment the inspiratory flow falls below this value
16132049|NCT01919424|Device|The English-Wright nebulizer|"Continuous-mode nebuilzer, designed to operate continuously with tidal breathing
~Roxon Medi-Tech, Montreal, PQ, Canada"
16132050|NCT01919411|Drug|Amoxicillin-Potassium Clavulanate|Patients in this arm will receive 500mg of Amoxicillin-Potassium Clavulanate Combination orally twice a day for 7 days after surgery.
16132051|NCT01919411|Drug|Placebo|Patients in this arm will receive 7 days of placebo after surgery.
16132052|NCT01919398|Drug|LY2940680|Administered orally
16132053|NCT01919385|Device|Predictive Low Glucose Minimizer|This study is a non-randomized feasibility study enrolling type 1 diabetics who are currently using an insulin pump. Participating Investigators will closely monitor the study subject in a clinical research center environment for approximately 30 hours, while controller algorithm determined insulin doses are delivered by an insulin pump, and utilizing continuous glucose monitoring results.
16132054|NCT01919372|Device|Telemedic assistance with a technological system|
16132055|NCT01919372|Other|Standard care|
16132056|NCT01919359|Dietary Supplement|Multizyme Cellular Vitality Cyruta Plus SHEP|
16132057|NCT01919346|Drug|Eculizumab|
16132058|NCT01919346|Drug|Normal Saline|
16132059|NCT01919320|Device|C2 Driver System TAH-t Patients|Comparison of two pneumatic drivers supporting the SynCardia TAH-t
16132060|NCT01919320|Device|CSS Console TAH-t Patients|Comparison of two pneumatic drivers supporting the SynCardia TAH-t.
16132061|NCT01919307|Other|Auricular acupuncture|The NADA Protocol for auricular acupuncture will be performed by the PI, a certified NADA protocol practitioner, using sterile, single-use, Seiren 0.22mm, one cm disposable detox needles. Both ears will be sterilized with alcohol swabs. There will be no electrical or other stimulation performed. Needles will be placed subcutaneously with one half twirl upon insertion to the following 5 points (in order per ear): Sympathetic, Shen Men, Kidney, Liver, Lung. Needles will remain in place for 40 minutes and will then be removed in the same order as they were inserted. Needles that become dislodged will be replaced per typical NADA protocol.
16132062|NCT01919294|Drug|testosterone undecanoate|Preparation: 1 gram in 4 ml of oily base. Requires no special storage conditions. Proposed regime: 1 mg as a single intramuscular injection at 0, 6, 18, 30 and 42 weeks
16132063|NCT01919281|Behavioral|strength training|
16132064|NCT01919281|Behavioral|interval training|
16132065|NCT01919268|Device|Electrotherapy|Combination of active interferential current with exercises of the Pilates method. Patients will receive 18 sessions of treatment over a period of 6 weeks (3 sessions/week). The exercises of Pilates method will be individualized to each patient's needs (pragmatic treatment).
16132066|NCT01919268|Device|Pilates|Combination of placebo interferential current with exercises of the Pilates method. Patients will receive 18 sessions of treatment over a period of 6 weeks (3 sessions/week). The exercises of the Pilates method will be individualized to each patient's needs (pragmatic treatment).
16132067|NCT01919255|Drug|Picolight + Coolprep|Picolight (1p/250cc, 5PM) + Coolprep (500cc x 2, 8PM)[Day-Prior] Picolight (1p/250cc, 7PM) + Coolprep (500cc x 2, 5AM)[Split-Dose]
16132068|NCT01919255|Drug|Picolight + Clicolon|Picolight (1p/250cc, 5PM) + Clicolon (4T x 4, 8PM) [Day-Prior] Picolight (1p/250cc, 7PM) + Clicolon (4T x 4, 5AM)[Split-Dose]
16132069|NCT01919242|Procedure|gastrectomy|gastrectomy with D1 + lymph node dissection for clinically early gastric cancer, and gastrectomy with D2 lymph node dissection for clinically advanced gastric cancer
16132070|NCT01919229|Drug|LEE011 (ribociclib)|Ribociclib was supplied in 200 mg hard gelatin capsules for oral use.
16132071|NCT01919229|Drug|letrozole|Letrozole was supplied in 2.5mg tablets for oral use.
16132072|NCT01919216|Drug|Citalopram|
16132073|NCT01919203|Drug|Remifentanil|The starting dose of remifentanil is 0.5μg/kg and a step size is 0.05μg/kg. If LMA insertion is successful or failed in previous patient, an decrement or increment of 0.05μg/kg remifentanil is injected to next patient, respectively.
16132074|NCT01919190|Drug|EXPAREL|TAP with EXPAREL
16132075|NCT01919190|Drug|Placebo|Placebo
16132076|NCT01919177|Dietary Supplement|Nitrate rich beetroot juice|Subjects will receive 140 mL of Nitrate-rich concentrated beetroot juice.
16132077|NCT01919177|Dietary Supplement|Nitrate depleted beetroot juice|Subjects will receive 140 mL of nitrate-depleted beetroot juice.
16132078|NCT01919164|Drug|Sprifermin|Participants received Sprifermin as intra-articular injection.
16132079|NCT01919164|Drug|Placebo|Participants received Placebo matched to sprifermin as intra-articular injection.
16132080|NCT01919125|Drug|IDX719|IDX719 supplied as 50 mg tablets.
16132081|NCT01919112|Device|tDCS|Anodal tDCS will be administered with swallowing exercises
16132082|NCT01919086|Drug|Bortezomib|Bortezomib SC (or IV if SC not tolerated) 1.5 mg/m^2, days 1, 8, 15 and 22
16132083|NCT01919086|Drug|Dexamethasone|Dexamethasone 40 mg PO or IV days 1, 4, 8,15 and 22 or on a split-dose regimen. (20mg BIW).
16132084|NCT01919086|Drug|Lenalidomide|Lenalidomide may be added to the patient's regimen at any time if there is evidence of hematologic disease progression
16132085|NCT01919073|Behavioral|Immediate Treatment Group|•The immediate treatment group will fill out the questions at the initial appointment and again after five treatment appointments. They will fill the questions out again at the first follow-up treatment appointment (approximately 4-5 months from the initial appointment), and then at the next (and last) follow-up appointment (approximately 7-8 months). The participants teacher will also be asked to fill out sets of questions.
16132086|NCT01919073|Behavioral|Delayed Treatment Group|•The wait list group will fill out the sets of questions again in 1-2 months. The question sets will then be completed again before beginning treatment four months from the initial completion and then again after five treatment appointments. The question sets will then be completed again at the first follow-up treatment appointment (approximately 8-9 months from the initial appointment) and at the next (and last) follow-up appointment (about 11-12 months from the initial appointment).
16132087|NCT01919047|Drug|Betanis|Oral
16132088|NCT01919021|Other|Magnetic Resonance Imaging MRI|400ml of milkshake and 12 agar beads are ingested and gamma scintigraphy scanning completed to document gastric emptying and outcome measures listed earlier.
16132089|NCT01919021|Other|Gamma Scintigraphy|400ml of milkshake and 12 agar beads are ingested and gamma scintigraphy scanning completed to document gastric emptying and outcome measures listed earlier.
16132090|NCT01919021|Procedure|Assessment of Gastric motor and sensory function|
16132091|NCT01919008|Drug|FK949E|Oral
16132092|NCT01918995|Drug|Regadenoson|Intravenous (IV)
16132093|NCT01918995|Drug|Placebo|Intravenous (IV)
16132094|NCT01918956|Biological|PURETHAL Birch, 20.000 AUM/ml|comparison of different up-dosing regimes
16132095|NCT01918943|Device|PLIF and Aspen (spinous process fixation device)|Circunferential fusion with PLIF and postero-lateral fusion with the Aspen device
16132096|NCT01918930|Biological|MGA271|MGA271 anti-B7-H3 monoclonal antibody
16132097|NCT01918917|Drug|Levobupivacaine|intraarticular
16132098|NCT01918917|Drug|Dexmedetomidine|intraarticular 1 ml (100 mcg)
16132099|NCT01918917|Drug|Morphine|intravenously, patient-controlled analgesia
16132100|NCT01918904|Drug|Sodium thiosulfate|A small amount of 25% topical sodium thiosulfate cream twice daily (bid)
16132101|NCT01918904|Drug|Placebo|A small amount of topical zinc oxide and aquaphor cream twice daily (bid)
16132102|NCT01918891|Behavioral|Nurse Practitioner Only|
16132103|NCT01918891|Behavioral|Nurse Practitioner + Health Coach|
16132104|NCT01918878|Drug|Aflibercept (EYLEA)|INTARAVITREAL INJECTION OF AFLIBERCEPT
16132105|NCT01918865|Drug|ISIS-PTP1BRx|
16132106|NCT01918865|Drug|Placebo|
16132107|NCT01918865|Drug|daily OAD (metformin and/or sulfonylurea)|
16132108|NCT01918852|Drug|Capecitabine|
16132109|NCT01918852|Drug|Teysuno|
16132110|NCT01918852|Drug|Bevacizumab|
16132111|NCT01918839|Device|VINCI Plus|VINCI Plus 1ml injected into wrinkle treatment area
16132112|NCT01918839|Device|Restylane-L|Restylane-L injected into wrinkle treatment area
16132113|NCT01918826|Device|TENS|
16132114|NCT01918813|Drug|vancomycin, mupirocin ointment|contact precautions, topical decolonization of MRSA by a bath with 4% chlorhexidine daily for 3-5 days
16132115|NCT01918800|Behavioral|Fatigue: Take control|Fatigue: Take Control, is the first formal education program modeled on the MS-related fatigue guideline
16132116|NCT01918800|Behavioral|MS: Take Control|MS: Take Control includes topics of interest to people with MS other than fatigue.
16132117|NCT01918787|Device|repetitive TMS|rTMS (intermittent theta burst stimulation 1200)over posterior superior temporal sulcus,dorsolateral prefrontal cortex and inion as Sham control
16132118|NCT01918774|Behavioral|Cognitive behavior therapy for work success (CBTw)|The CBTw program includes 12 sessions that are delivered in a weekly one-hour group format. Sessions focused on identifying and modifying maladaptive thoughts related to work, enhancing self efficacy and beliefs in one's ability to succeed at work, identifying and addressing personal barriers to work, and increasing beneficial coping strategies that can be applied across employment settings, including during the job search phase and working on the job. The intervention is tailored toward both employed and unemployed persons seeking community work. Session content includes the following modules: Introduction-Work goals and work story; CBT model and work; Thinking about work; Barriers to work; Coping with stress and anxiety; Coping with anger and difficult emotions; Communication at work; Dealing effectively with people at work; Managing work success; Personal work success plan.
16132119|NCT01918761|Drug|Dacomitinib, Pemetrexed|Pemetrexed 500mg/m2 i.v (q21d) Dacomitinib 45mg orally (continuous)
16132120|NCT01918748|Device|Haptic Master|The Haptic Master (HM) is a haptic device controlled according to the principles of 'admittance control'. In admittance control 'force' applied to the system (i.e. the HM arm) is measured, while 'position' (of the HM arm) is the end result.
16132121|NCT01918735|Drug|Placebo|Placebo control matched to the oral or intravenous experimental comparator drug
16132122|NCT01918735|Drug|GWP42006|"Oral administration of 25 (Group/dose level 1a and 1b), 75 (Group/dose level 2a and 2b), 200 (Group/dose level 3a and 3b) and 400 mg GWP42006 (Group/dose level 4a and 4b), provided as 50 mg/mL GWP42006 solution in sesame oil containing flavourings and sweetener, for dilution on the day of dosing, as required.
~Additional intravenous administration of 5 mg GWP42006 and 10 mL Solutol HS 15 solution to Group/dose level 3a and 3b subjects."
16132123|NCT01918722|Drug|ICH-1(herbal medicine with Hirudo, Tabanus)|8herbals (with 2 herbals of Activating blood stagnation and expelling blood stasis herbs) one dose, bid, for 10 days
16132124|NCT01918722|Drug|placebo|placebo herbal medicine, one dose,bid, for 10 days
16132125|NCT01918722|Drug|ICH-2(herbal medicine without Hirudo, Tabanus)|(6herbals, without 2 herbals of promoting blood stasis) one dose, bid, for 10 days
16132126|NCT01918709|Drug|Sequence 1 : Period 1(V) Period 2(R) Period 3(V+R)|Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
16132127|NCT01918709|Drug|Sequence 2 : Period 1(V+R) Period 2(V) Period 3(R)|Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
16132128|NCT01918709|Drug|Sequence 3 : Period 1(R) Period 2(V+R) Period 3(V)|Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
16132129|NCT01918709|Drug|Sequence 4 : Period 1(V+R) Period 2(R) Period 3(V)|Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
16132130|NCT01918709|Drug|Sequence 5 : Period 1(R) Period 2(V) Period 3(V+R)|Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
16132131|NCT01918709|Drug|Sequence 6 : Period 1(V) Period 2(V+R) Period 3(R)|Valsartan = Antihypertensive drug / Rosuvastatin = Antihyperlipidemic drug
16132132|NCT01918696|Behavioral|Anger Reduction Treatment|Eight 15-minute sessions of interpretation modification to reduce angry interpretation biases.
16132133|NCT01918696|Behavioral|Progressive Muscle Relaxation|Eight 15-minute sessions of progressive muscle relaxation (PMR) including formulation of a plan to use PMR when angry.
16132134|NCT01918696|Behavioral|Control Condition|Eight 15-minute sessions of informative videos on healthy living.
16132135|NCT01918683|Radiation|TACE transarterial chemoembolization|
16132136|NCT01918683|Radiation|stereotatic body radiotherapy (SBRT)|
16132137|NCT01918670|Procedure|catheter ablation of atrial fibrillation|electric pulmonary vein disconnection
16132138|NCT01918657|Drug|walnut powder|Subjects will be randomized in a 2:1 ratio into either an active treatment group (final dose 1500 mg walnut protein, n=20) or a placebo group (n=10). Subjects will undergo a one-day desensitization protocol designed to enable the subject to tolerate 6 mg of walnut protein or placebo (initial day escalation phase). After the initial escalation day achieving at least 1.5 mg and up to 6 mg of walnut protein or placebo, dosing build-up will occur every two weeks through dose 24 at 34 weeks. A maintenance dose will be given for 4 weeks followed by a 5 gram protein OFC to walnut and a 5 gram protein OFC to a second tree nut (at ~38 weeks), after which the study will be unblinded. Placebo subjects that fail the OFC will be crossed over to active treatment and escalated as described to the 1500 mg target dose.
16132139|NCT01918657|Drug|walnut powder|escalating doses of walnut powder
16132140|NCT01918644|Radiation|stereotactic body radiation therapy|Undergo SBRT
16132141|NCT01918644|Drug|capecitabine|Given PO
16132142|NCT01918644|Procedure|therapeutic conventional surgery|Undergo definitive surgery
16132143|NCT01918644|Procedure|magnetic resonance imaging|Optional correlative studies
16132144|NCT01918644|Other|laboratory biomarker analysis|Optional correlative studies
16132145|NCT01918631|Drug|tenofovir disoproxil fumarate|
16132146|NCT01918631|Drug|Entecavir|
16132147|NCT01918605|Device|Diluted spacer|
16132148|NCT01918605|Device|Non-diluted spacer|
16132149|NCT01918592|Device|MRI/acetate-PET imaging|
16132150|NCT01918579|Procedure|Patients will be tested by rapid POC CRP test|Patient will be tested with CRP test. Treatment decisions including any antibiotics prescribed will be based on test results and clinical judgement. Treatment choices are not recommended/prescribed by the study protocol.
16132151|NCT01918566|Dietary Supplement|tap water|
16132152|NCT01918566|Dietary Supplement|Single intragastric instillation of 75g Glucose in 300ml tap water via nasogastric tube|
16132153|NCT01918566|Dietary Supplement|Single intragastric instillation of 75g Glucose in 300ml tap water with 450ppm lactisole|
16132154|NCT01918566|Dietary Supplement|25g Fructose in 300ml tap water|
16132155|NCT01918566|Dietary Supplement|75g glucose in 300ml tap water with 600pmol/kg/min exendin 9-39|
16132156|NCT01918566|Dietary Supplement|300ml tap water with 450ppm lactisole|
16132157|NCT01918553|Other|clinical parameters|
16132158|NCT01918553|Other|visual acuity exams|
16132159|NCT01918553|Other|retinophotography|
16132160|NCT01918553|Other|SD-OCT|
16132161|NCT01918553|Other|Intra ocular Pressure (IOP)|
16132162|NCT01918553|Other|retinal imaging (OPTOMAP)|
16132163|NCT01918553|Other|axial length (IOL master)|
16132164|NCT01918540|Procedure|Hollow Centralizer|The stem used (MS30)was originally designed with a solid centralizer but has been redesigned to be used with a hollow centralizer. The patients are randomized to either solid or hollow centralizer
16132165|NCT01918540|Procedure|Solid Centralizer|The stem used (MS30)was originally designed with a solid centralizer but has been redesigned to be used with a hollow centralizer. The patients are randomized to either solid or hollow centralizer
16132166|NCT01918540|Device|MS-30 femoral stem|This is the stem used in the study.
16132167|NCT01918527|Drug|Capecitabine|Orally on days 1-14: 2000 mg/m2/day q3w
16132168|NCT01918527|Drug|Oxaliplatin|Intravenously on day 1: 130 mg/m2 q3w
16132170|NCT01918501|Procedure|Blood testing|Blood sample will be taken once from 120 volunteers. The blood will be examine in a blind fashion, including 60 MS patients diagnosed by a neurologist based on clinical and MRI findings. The control group will include 50 age and gender match healthy volunteers and 10 more patients with unrelated neurological diseases
16132171|NCT01918488|Dietary Supplement|Standardized salt diet|200 mmol NaCl per day given as three meals daily for 4 consecutive days.
16132172|NCT01918488|Drug|Amiloride|Amiloride tablet 20 mg two times daily (morning and afternoon) for two consecutive days.
16132173|NCT01918475|Drug|Carbetocin|Carbetocin 0.1 mg single dose is intravenously administered
16132174|NCT01918475|Drug|Placebo|1ml of NaCl 0.9% is administered intravenously
16132175|NCT01918449|Other|Clinical follow up by general practitioners in primary care|The study evaluates two different setting to follow up patients with obstructive sleep apnea on CPAP treatment
16132176|NCT01918436|Behavioral|TEAMS intervention|In the child group the children are introduced to games that are designed to enhance inhibitory control, working memory, attention, visuospatial abilities, planning, and motor skills. The parent group consists of psychoeducation and instructions in how to encourage playing these games with their children and how to support the child's development.
16132177|NCT01918436|Other|Control group|The control groups receive the standard treatment program, outlined by the clinical guidelines of Region Zealand, Denmark.
16132178|NCT01918423|Behavioral|Lifestyle intervention during pregnancy|Energy requirements for each participants´ mother were individually estimated according to weight and level of activity during pregnancy. Women in the active intervention group were encouraged to be moderately physically active 30-60 minutes a day.Women in this group also had free full time membership in a fitness center for six months. In the fitness centers they had closed training classes with trained physiotherapists for one hour each week.
16132179|NCT01918410|Device|Contact Lens with alginic acid|Worn for 7 days, at least 8 hours a day
16132180|NCT01918410|Device|Contact Lens without alginic acid|Worn for 7 days, at least 8 hours a day
16132181|NCT01918397|Drug|Levofloxacin|Levofloxacin is a quinolone antibiotic used to treat lung, sinus, skin, and urinary tract infections caused by bacteria. The chemical name is (-)-(S)-9fluoro-2,3-dihydro-3-methyl-10-(4-methyl-1-piperazinyl)-7-oxo-7H-pyrido[1,2,3-de]-1,4benzoxazine-6-carboxylic acid hemihydrate.
16132182|NCT01918397|Drug|Optimized background regimen (OBR)|"For this study OBR will mean optimized background regimen, not including a quinolone. OBR will be selected at the discretion of the study investigator to conform with standards of care and local site guidelines. In general, the OBR regimen should include at least 3 drugs (other than levofloxacin) to which the patient's isolate is not expected to be resistant, with one of these being an injectable agent, at the usual recommended doses."
16132183|NCT01918384|Drug|NPC-14|"NPC-14 will be administrated as following steps. The dose of NPC-14 will be calculated and adjusted by a non-blinded medical doctor and/or a non-blinded pharmacist.
~An initial dose of NPC-14 will be half of that calculated by distribution volume：Vd based on patient age for safety reason.
~After the initial administration, the dose of NPC-14 will be adjusted and maintained by actual Vd, therapeutic drug monitoring of peak serum levels of NPC-14"
16132184|NCT01918384|Drug|Placebo|Dose will be adjusted by volume of distribution (Vd) of patients in accordance with the NPC-14 dose regimen
16132185|NCT01918371|Drug|Anti-VEGF|Patients with retinal vein occlusion or diabetic macular edema receiving anti-VEGF injection(s) in accordance with standard of care practices. This is a retrospective chart review study.
16132186|NCT01918358|Drug|Sequence 1 : Period 1 (VR 160/20 mg-1), Period 2(VR 160/20 mg-2), Period (V+R)|
16132187|NCT01918358|Drug|Sequence 2 : Period 1 (VR 160/20 mg-2), Period 2 (V+R), Period 3 (VR 160/20 mg-1)|
16132188|NCT01918358|Drug|Sequence 3 : Period 1 (V+R), Period 2 (VR 160/20 mg-2), Period 3 (VR 160/20 mg-1)|
16132189|NCT01918358|Drug|Sequence 4 : Period 1 (VR 160/20 mg-1), Period 2 (V+R), Period 3 (VR 160/20 mg-2 )|
16132190|NCT01918358|Drug|Sequence 5 : Period 1 (VR 160/20 mg-2), Period 2 (VR 160/20 mg-1), Period 3 (V+R )|
16132191|NCT01918358|Drug|Sequence 6 : Period 1 (V+R), Period 2 (VR 160/20 mg-1), Period 3 (VR 160/20 mg-2)|
16132192|NCT01918345|Behavioral|Home-based Physical Activity Program with Health Coach|This arm will receive either a trained CDE or R. Kin as a health coach and a home-based physical activity program for 6 months. Health coaches will provide one-on-one motivational interviewing (MI) and goal-setting, and will account for baseline fitness, resources, childcare, and breastfeeding, to be undertaken at participants' homes or in their communities. Prescriptions will be based on minimum recommendations for moderate-intensity exercise for postpartum women. Participants will maintain at least 150 min/week of moderate activity at a target heart rate of 30-80% with a perceived exertion of 12-15 on the Borg Scale. They will also be counseled on resistance training and pelvic floor exercises. They will receive regular telephone-based coaching to advance goals. Phone-calls will be administered on a weekly basis during weeks 2-8 of the intervention, biweekly basis on weeks 10-12, and monthly basis on weeks 16-24.
16132193|NCT01918345|Behavioral|Home-based Low-GI Diet Program with Health Coach|This arm will receive a trained CDE health coach and a home-based low-GI diet program for 6 months. Health coaches will provide baseline education during a one-on-one visit and use MI to introduce the dietary intervention. Low GI education will be layered on top of current standard care, which asks women to consume a diet comprised of 45-65% carbohydrates (25 g of dietary fibre), 10-30% protein, and 25-35% fat. As per standard care at the DEPs, this intake will be divided into 3 meals and 2 to 4 snacks. Resources for women will include a low GI dietary food substitution list, a recipe booklet, and a tip sheet on how to lower dietary GI. Women will receive regular telephone-based coaching to advance goals. Phone-calls will be administered on a weekly basis during weeks 2-8 of the intervention, biweekly basis on weeks 10-12, and monthly basis on weeks 16-24.
16132194|NCT01918332|Drug|Valsartan 160mg|
16132195|NCT01918332|Drug|Rosuvastatin 20mg|
16132196|NCT01918332|Drug|Valsartan 160mg placebo|
16132197|NCT01918332|Drug|Rosuvastatin 20mg placebo|
16132198|NCT01918319|Behavioral|Lifestyle intervention|Energy requirements for each participant were individually estimated according to weight and level of activity during pregnancy. Women in the active intervention group were encouraged to be moderately physically active 30-60 minutes a day.Women in this group also had free full time membership in a fitness center for six months. In the fitness centers they had closed training classes with trained physiotherapists for one hour each week.
16132199|NCT01918306|Drug|cisplatin|"In Arm I patients receive cisplatin IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients may crossover to Arm II upon disease progression.
~In Arm II patients receive cisplatin as in Arm I and PI3K inhibitor GDC-0941 orally (PO) one time a day (QD) on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
~--------------------------------------------------------------------------------"
16132200|NCT01918306|Other|laboratory biomarker analysis|correlative studies
16132201|NCT01918306|Other|pharmacological study|correlative studies
16132202|NCT01918306|Procedure|dynamic contrast-enhanced MRI, diffusion-weighted MRI & chemical exchange saturation transfer MRI|correlative studies
16132203|NCT01918306|Drug|GDC -0941|Patients receive cisplatin as in Arm I and PI3K inhibitor GDC-0941 PO QD on days 2-6, 9-13, 16-20, and 23-27. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
16132204|NCT01918293|Device|SMART ARM|The smartphone application for self-management of Asthma offers symptom diary, general information for asthma, the information of asthma drugs,the guideline for inhaler and the specific action plan according to daily symptom and FEV1.
16132205|NCT01918280|Procedure|Seminal analyses and testicular biopsy|Two seminal analyses spaced out 3 months followed by a testicular biopsy if the azoospermia is confirmed on semen analyses.
16132206|NCT01918254|Drug|Paclitaxel|Paclitaxel IV infusion will be administered as per schedule described in individual arm.
16132207|NCT01918254|Drug|Pertuzumab|Pertuzumab IV infusion will be administered as per schedule described in individual arm.
16132208|NCT01918254|Drug|Lumretuzumab|Lumretuzumab will be administered as per schedule described in individual arm.
16132209|NCT01918241|Drug|pegfilgrastim,30mcg/kg|Two doses SC injection of 30 mcg/kg at postchemotherapy 48hr and 120hr in cycle 2.
16132210|NCT01918241|Drug|pegfilgrastim, 60mcg/kg|Single SC injection of the appropriate dose of drug ranging from 60 mcg/kg to 100 mcg/kg at postchemotherapy 48hr in cycle 2.
16132211|NCT01918241|Drug|pegfilgrastim, 100mcg/kg|Single SC injection of the appropriate dose of drug ranging from 60 mcg/kg to 100 mcg/kg at postchemotherapy 48hr in cycle 2.
16132212|NCT01918241|Drug|filgrastim, 5mcg/kg|At least 7 days SC injection of 5 mcg/kg at postchemotherapy 48hr in cycle 2.
16132213|NCT01918228|Behavioral|Talks about what science says about LBP|Two talks, a folder with general stretching exercises and possibility to contact health professional by telephone
16132214|NCT01918215|Device|ICD|
16132215|NCT01918215|Device|ILR|
16132216|NCT01918202|Drug|20 mg PF-02545920|Subject will receive a single dose of 20 mg PF-02545920.
16132217|NCT01918202|Drug|PF-02545920|"The dose will be selected based on the results obtained for Cohort 1. Dose options range from 30 mg to 10 mg, 5 mg, 2mg, 1 mg.
~This cohort is optional."
16132218|NCT01918202|Drug|PF-02545920|The dose will be selected based on the results obtained for Cohort 1 and cohort 2.
16132219|NCT01918189|Behavioral|behavioral pain self-management intervention Pain EASE|10 modules describing behavioral and cognitive pain coping skills such as relaxation and stress reduction methods, exercise and structured physical activity, and activity pacing
16132220|NCT01918176|Drug|Palbociclib alone|Single dose of 125mg Palbociclib capsule will be administered to subjects orally and then PK samples will be collected at 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours.
16132221|NCT01918176|Drug|Palbociclib + Rabeprazole|Two Rabeprazole 20mg tablets will be given to subjects orally once daily for 7 days. Then on the same day at least 4 hours after the last dose of Rabeprazole, single dose of 125mg Palbociclib capsule will be given to subjects orally then followed by PK samplings at 1, 2, 4, 6, 8, 12, 24, 48, 72, 96 and 120 hours.
16132222|NCT01918163|Dietary Supplement|Pomegranate pills|
16132327|NCT01917409|Device|conventional laryngoscopy|the device is to assist nasotracheal intubation
16132223|NCT01918150|Device|Titan 2 stents|The intervention is called Percutaneous Coronary Intervention (PCI); Commonly known as coronary angioplasty or simply angioplasty, it is a non-surgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease. PCI is usually performed by an interventional cardiologist.
16132224|NCT01918150|Device|Cobalt-Chromium Bare Metal Stents|The intervention is called Percutaneous Coronary Intervention (PCI); Commonly known as coronary angioplasty or simply angioplasty, it is a non-surgical procedure used to treat the stenotic (narrowed) coronary arteries of the heart found in coronary heart disease. PCI is usually performed by an interventional cardiologist.
16132225|NCT01918137|Dietary Supplement|chocolate bar|
16132226|NCT01918137|Dietary Supplement|Porridge|
16132227|NCT01918124|Radiation|radiotherapy|Pelvic radiation to 45 Gy, 1.8 Gy per day, five days per week (25 fractions) or intensive modulated pelvic radiotherapy, with brachytherapy boost to the vagina if total abdominal hysterectomy and bilateral salpingo-oophorectomy was done in surgery, or with paraaortic radiation if paraaortic lymphnode metastases were found after surgery.
16132228|NCT01918124|Drug|Cisplatin|Two courses cisplatin (50mg/m2) given on days 1 and 28 during radiotherapy.
16132229|NCT01918124|Drug|Cisplatin and Doxorubicin and Cyclophosphamide|Four courses of cisplatin (50mg/m2) and doxorubicin (60mg/m2) and cyclophosphamide (600mg/m2) chemotherapy given at 3 week intervals following completion of radiotherapy.
16132230|NCT01918124|Drug|Paclitaxel and Carboplatin|Or four courses of Paclitaxel(135mg/m2) and carboplatin (AUC=5) given at 3 week intervals following completion of radiotherapy.
16132231|NCT01918111|Procedure|Renal denervation|Renal denervation will be performed via common femoral artery with standard endovascular technique and simplicity catheter
16132232|NCT01918111|Drug|adenosine infusion treatment|Continue hypertensive medication
16132233|NCT01918098|Drug|Oxycodone/naloxone prolonged release tablets|
16132234|NCT01918085|Other|Hydrocolloid strip|An adhesive strip made of hydrocolloid adhesive
16132235|NCT01918085|Other|Strata strip|An adhesive strip made of the Strata adhesive
16132236|NCT01918072|Other|Clinical innovation|Technology-based intervention that combines interactive communication with women's health specialists and ongoing education
16132237|NCT01918059|Procedure|Tissue Adhesive skin closure|The approach to repair will follow standard technique. If eyelid marginal component is present, margin repair will be performed with two 6-0 interrupted silk sutures: one at the gray line and one at the lash line. If the tarsus requires reapproximation, this will carefully be done using interrupted polyglactin vicryl sutures. The superficial skin will then be repaired with tissue adhesive (octyl-2-cyanoacrylate).
16132238|NCT01918059|Procedure|Absorbable suture skin closure|The approach to repair will follow standard technique. If eyelid marginal component is present, margin repair will be performed with two 6-0 interrupted silk sutures: one at the gray line and one at the lash line. If the tarsus requires reapproximation, this will carefully be done using interrupted polyglactin vicryl sutures. The superficial skin will then be repaired with absorbable sutures (surgical gut).
16132239|NCT01918059|Procedure|Non-absorbable suture skin closure|The approach to repair will follow standard technique. If eyelid marginal component is present, margin repair will be performed with two 6-0 interrupted silk sutures: one at the gray line and one at the lash line. If the tarsus requires reapproximation, this will carefully be done using interrupted polyglactin vicryl sutures. The superficial skin will then be repaired with either non-absorbable sutures (6-0 polypropylene).
16132240|NCT01918033|Drug|Desloratadine 5 mg|Desloratadine 5 mg tablets
16132241|NCT01918033|Drug|Placebo|Matching placebo to desloratadine 5 mg tablets
16132242|NCT01918020|Behavioral|Go Wild with Fruits and Veggies!|Fruits and Vegetables
16132243|NCT01918020|Behavioral|Go Wild with Fruits and Veggies! delayed|Go Wild with Fruits and Veggies! delayed
16132244|NCT01918007|Procedure|Adenotonsillectomy (AT)|Standard surgical intervention for treatment of Obstructive SDB.
16132245|NCT01917994|Behavioral|Text Messages|The intervention consists of supportive, informational, and motivational text messages three times a week targeting the following domains: promoting a sense of connectedness to the clinic, fostering social support, building empowerment, ameliorating negative affect, cultivating positive affect, and promoting healthy behaviors and adherence to antiretroviral medication.
16132246|NCT01917994|Behavioral|Appointment Reminders|
16132247|NCT01917981|Device|Personal Heart Rhythm Monitor|
16132248|NCT01917968|Device|Uphold Lightweight Vaginal Support System|Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)
16132249|NCT01917968|Procedure|Traditional native tissue repair|Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
16132250|NCT01917942|Device|Humidification|Fisher and Paykel Healthcare MR880 humidifier + HC211 flow source. 37/44 Humidification (37oC at 100% relative humidity, 44 mg of water per litre of air, 25 litres per min initial flow rate). The patients will be instructed to use humidification from day 1 of the radiotherapy course as much as is practical; the preference is for continuous overnight humidification plus maximal use throughout the day.Humidification will continue throughout treatment until at least week 8 after the commencement of radiotherapy and will cease when the CTCAE mucositis (clinical exam) score becomes less than grade 2, or at the week 16 assessment, whichever is earliest.
16132251|NCT01917942|Other|Standard of Care|SOC: institutional standard of care for the management of mucositis. SOC will be defined by each participating institution and be kept consistent at that institution for the duration of the study. In general, SOC will consist of rinsing with 50:50 salt bicarbonate of soda mouthwash; benzydamine mouthwash; appropriate analgesic, antimicrobial and antifungal protocols etc.
16132253|NCT01917916|Drug|Placebo|Placebo
16132254|NCT01917916|Drug|BI 655064|
16132255|NCT01917916|Drug|BI 655064|
16132256|NCT01917916|Drug|BI 655064|
16132257|NCT01917916|Drug|Placebo|Placebo
16132258|NCT01917916|Drug|BI 655064|
16132259|NCT01917916|Drug|Placebo|
16132260|NCT01917916|Drug|Placebo|Placebo
16132261|NCT01917903|Behavioral|Gait-cognitive training|Participants will engage in a four week treadmill training program with a secondary cognitive component aimed at improving both walking and multitasking.
16132502|NCT01915979|Biological|Plasma rich in growth factors (PRGF)|
16132262|NCT01917903|Behavioral|Identification of at risk variables|Participants will complete walking under three conditions: walking alone for six minutes; standing from a chair, walking 3 meters, turning, and returning to a seated position (TUG); and standing from a chair, walking 3 meters turning and returning to a seated postion while subtracting numbers (TUG Cognitive). Spatiotemporal measures of gait will be collected.
16132263|NCT01917890|Dietary Supplement|Curcumin|"Patients undergo 74 Gy of intensity-modulated radiotherapy 5 times a week for 7-8 weeks.
~Patients take 3 grams of BCM95 Curcumin (as 6 × 500 mg capsules)"
16132264|NCT01917890|Dietary Supplement|Placebo|"Patients undergo 74 Gy of intensity-modulated radiotherapy 5 times a week for 7-8 weeks.
~Patients take 3 grams of roasted rice powder (as 6 × 500 mg capsules)"
16132265|NCT01917877|Drug|Bevacizumab|Bevacizumab 7mg/kg iv on day1 and 21, followed by Dexamethasone 10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20
16132266|NCT01917877|Drug|Dexamethasone|Dexamethasone 10mg iv d 1-10, then 5mg iv d11-15, 2.5mg iv d16-20
16132267|NCT01917864|Behavioral|iPad Application|A specialized iPad application, entitled SpeechPrompts, has been developed to treat prosodic difficulties commonly seen in ASDs. SpeechPrompts provides the SLPs that work with students with ASDs an additional tool to treat prosody. The SpeechPrompts software offers visual support and biofeedback to change prosody. These two tools are not typically available for school-based SLPs.
16132268|NCT01917838|Behavioral|MFG plus MyMFG|"Specific aim is to utilize mHealth to improve the Design and Do process of HW within the context of the Family Groups for Youth with Behavioral Difficulties (MFG) intervention, an EBT for DBDs in youth and their families who seek assistance at outpatient mental health clinics in urban communities.
~The first component focuses on delivering HW via a highly engaging, multiplayer, interactive, cooperative, and skill-building game platform aimed at improving the Design and Do process of HW. The second component focuses on targeting factors putatively related to poor HW implementation within the Do process."
16132269|NCT01917825|Drug|MDT-15|
16132270|NCT01917812|Device|Digital Activity Tracker|
16132271|NCT01917812|Other|Smart Text Messaging|
16132272|NCT01917799|Drug|Aspirin|75mg tab of LDA once daily for 7 months
16132273|NCT01917799|Drug|Heparin|0.4 mL/day of the Enoxaparin
16132274|NCT01917786|Device|ECG|
16132275|NCT01917773|Drug|Octreotide|Average MI for all patients was calculated over 15-minutes, 30-minutes and 45- minutes before and after administration of octreotide
16132276|NCT01917773|Drug|Bisacodyl|
16132277|NCT01917747|Behavioral|Patient Navigator|The patient navigator group will involve regular phone contact with the patient navigator. The patient navigator will contact the participant by phone to conduct an interview and provide education on infant hearing and diagnostic hearing services. The timing of the subject child's appointment and the instructions of the outpatient auditory brainstem response test are discussed. In the second part of the study, further educational tools are given to parent(s) and discussion of additional follow up mechanisms, including community hearing services and types of interventions for pediatric hearing loss is imparted.
16132278|NCT01917747|Behavioral|Standard scheduling and follow-up|The subjects will have access to discuss any questions or concerns with our office or audiology staff, as is the standard of care practice. They will not be contacted by study personnel or the patient navigator after discharge from the hospital and before the initial diagnostic test or before any subsequent auditory brainstem response test. The patients may contact and be contacted by our clinic staff regarding scheduling or rescheduling of the hearing test, as is standard practice.
16132279|NCT01917734|Other|Therapeutic feeding for children with SAM|Comparison of outcomes between children with complicated SAM and children with uncomplicated SAM as well as comparisn of outcomes against national and internationally agreed upon standards of care
16132280|NCT01917721|Drug|Doxycycline|The interventional arm of the study will receive doxycycline 4.4 mg/kg/day for 21 days besides receiveing standard care: IVIG and/or Remicade.
16132281|NCT01917721|Drug|Placebo|Standard medical care and placebo will be provided to the comparative arm of the study administering IVIG and/or Remicade, but not doxycycline.
16132282|NCT01917708|Drug|Abatacept|All patients will receive 4 doses of abatacept in addition to standard GVHD prophylaxis with cyclosporine and mycophenolate mofetil.
16132283|NCT01917695|Drug|Chemotherapy|cisplatin 75 mg/m2 Paclitaxel 175 mg/m2
16132284|NCT01917695|Radiation|External Beam Radiotherapy|50 Gy/2 Gy/25 # external beam RT to cervix. four field technique. given concurrently with chemotherapy weeks 1 - 5
16132285|NCT01917695|Radiation|Brachytherapy|Ir - 192 HDR Brachytherapy - intracavitary. 7Gy x 3#. given after completion of chemoRT.
16132286|NCT01917695|Procedure|Radical Hysterectomy|Type III Radical Hysterectomy + Bilateral Pelvic Node Dissection
16132287|NCT01917682|Procedure|CorPath-assisted Percutaneous Coronary Intervention|Robotic-assisted Percutaneous Coronary Intervention
16132288|NCT01917656|Drug|liraglutide|1.8 mg administered subcutaneously (s.c., under the skin) once daily
16132289|NCT01917656|Drug|metformin|Subjects will continue on their pre-trial metformin tablet treatment, dose unchanged
16132290|NCT01917656|Drug|sulphonylurea|Subjects will continue on their pre-trial SU tablet treatment, doses unchanged
16132291|NCT01917630|Drug|ALV003|ALV003 is an orally administered mixture of two enzymes (cysteine endoprotease B-isoform 2 and prolyl endopeptidase)
16132292|NCT01917630|Drug|placebo|
16132293|NCT01917617|Drug|Gemcitabine , Cisplatin, Oral Rehydration Solution (ORS)|"Short hydration via oral rehydration solution (OS-1)
~Cisplatin plus gemcitabine will be administered via infusion as follows; 500 ml of 0.9% saline including cisplatin (25 mg per square meter of body-surface area) over 1 hour followed by 250 ml of 0.9% saline including gemcitabine over 30 minutes. Before and after the infusion, each 500ml bottle of oral rehydration solution (OS-1) will be taken respectively."
16132294|NCT01917617|Drug|Gemcitabine , Cisplatin|"Standard hydration via intravenous infusion
~Cisplatin plus gemcitabine will be administered via usual infusion regimen by each hospital. In general, it is administered total 2 litters over 3 hours or more."
16132295|NCT01917604|Procedure|open exposure|the open surgical methods of exposing the canine is compared with control
16132296|NCT01917604|Procedure|closed exposure|closed exposure is compared with control
16132297|NCT01917591|Device|Punch biopsies treated with MariGen Wound ECM dressing|Weekly dressing changes and review of wounds.
16132298|NCT01917591|Device|Punch biopsies treated with Oasis ECM dressing|Weekly dressing changes and wound review
16132299|NCT01917578|Device|Ultrasound|"Evaluation of the tumor size by sonography is performed before neoadjuvant chemotherapy and prior to surgery.
~Measurement of tumor size refers to WHO standards."
16132300|NCT01917578|Procedure|CNB|Typically, the pretreatment tumor specimen will be a core needle biopsy. Because 15% to 28% of patients will have no residual tumor after NAT, it is important to have an adequate pretreatment sample in which an unequivocal diagnosis of invasive carcinoma is established and evaluation of hormone receptors and HER2/ neu status is completed before treatment.
16132301|NCT01917578|Procedure|BCS, Modified Radical Mastectomy|All patients after neoadjuvant chemotherapy are performed BCS and modified radical mastectomy.
16132302|NCT01917578|Device|Pathologic Large Tissue Selected Table|"Pathologic large tissue selected table has obtained Chinese patent.Its license ID is CN101261200.
~Each piece of breast tissues by cutting with the table has 3mm thickness."
16132303|NCT01917578|Device|Leica TP1020|"Procedure:
~Alcohol 70 % 1h
~Alcohol 80 % 1h
~Alcohol 85 % 1h
~Alcohol 90 % 1h
~Alcohol 95 % 1h
~Alcohol Ⅰ 100 % 1h
~Alcohol Ⅱ 100 % 1h
~Xylene Ⅰ 2h
~Xylene Ⅱ 2h
~Xylene Ⅲ 2h
~Paraffin 6h
~Paraffin 6h"
16132304|NCT01917578|Device|Pathologic Large Tissue Embedded Table|"The table is made of brass .It is applying for a chinese patent.
~The table can simultaneously embed 8 piece of breast tissues."
16132305|NCT01917578|Device|Leica SM2000 R|Each of paraffin section has 4 um thickness.
16132306|NCT01917578|Procedure|HE Stain|"Procedure:
~Xylene Ⅰ 60℃ 15-20 minutes
~Xylene Ⅱ 60℃ 15-20 minutes
~Alcohol 100% Ⅰ 3-5 minutes
~Alcohol 100% Ⅱ 3-5 minutes
~Alcohol 95% Ⅱ 3-5 minutes
~Alcohol 90% Ⅱ 3-5 minutes
~Wash in running tap water for 3 minutes
~Hematoxylin 5-10 minutes
~Wash in running tap water for 3 minutes
~Differentiate in 1% acid alcohol for 30 seconds
~Wash in running tap water for 1 minute
~Bluing in 0.2% ammonia water for 30-60 seconds
~Wash in running tap water for 3 minutes
~Counterstain in eosin Y solution for 30-60 seconds
~Wash in running tap water for 1 minute
~Alcohol 90% Ⅱ 2-3 minutes
~Alcohol 95% Ⅱ 2-3 minutes
~Alcohol 100% Ⅱ 3-5 minutes
~Alcohol 100% Ⅱ 3-5 minutes
~Xylene Ⅲ 5-10 minutes
~Xylene Ⅳ 5-10 minutes
~Mounting with neutral resin"
16132307|NCT01917578|Device|CX22|The residual tumor areas are microscopically outlined on each slice by pathologist.
16132308|NCT01917578|Device|Epson V600|"Each slice that has been microscopically outlined is scanned by Epson V600.
~Every image by scanning should be saved as JPG."
16132309|NCT01917578|Device|MRI|"Evaluation of the tumor size by MRI was performed before neoadjuvant chemotherapy and prior to surgery.
~Measurement of tumor size refers to WHO standards.
~The images of patients which were scanned by MRI should be burned onto disc for 3d reconstruction."
16132310|NCT01917578|Procedure|Three-Dimensional Reconstruction|"A.Pathological images three-dimensional reconstruction:
~Pathological images registration is based on skin and shear mark by Photoshop 13.0 software.
~Residual tumor boundary on Pathological images after registration are outlined and taken three-dimensional reconstruction by 3D-doctor 4.0 software.
~Observe the shrinkage modes in three-dimensional space.
~According to WHO standard,the boundaries of all residual tumor images are displayed in one plane and the longest diameter and its longest perpendicular diameter of boundaries are measured in one-dimensional space.
~According to RECIST standard,the longest diameter of boundaries of residual tumor images in three-dimensional space.
~B.MRI images three-dimensional reconstruction:the procedure is similar to Pathological images three-dimensional reconstruction"
16132311|NCT01917578|Device|Mammography|"Evaluation of the tumor size by mammography is performed before neoadjuvant chemotherapy and prior to surgery.
~Measurement of tumor size and calcification extent refers to WHO standards.
~Calcification extent is not only measured in mammography image but also under microscope."
16132312|NCT01917578|Drug|TAC,TC,TA,CAF,CEF|"TAC:Docetaxel 75 mg/㎡ iv day 1 + Doxorubicin 50 mg/㎡ in day 1 + Cyclophosphamide 500 mg/㎡ iv day 1(Cycled every 21 days for 3 cycles)
~TC:Docetaxel 75 mg/㎡ iv day 1 + Cyclophosphamide 600 mg/㎡in day 1(Cycled every 21 days for 2 cycles)
~TA:Docetaxel 75 mg/㎡ iv day 1 + Doxorubicin 50 mg/㎡ in day 1(Cycled every 21 days for 2 cycles)
~CAF:Cyclophosphamide 100 mg/㎡ po days 1-14 + Doxorubicin 30 mg/㎡ iv days 1,8 +5-fluorouracil 500 mg/㎡ iv days 1,8(cycled every 28 days for 3 cycles)
~CEF:Cyclophosphamide 75 mg/㎡ po day 1-14 + Epirubicin 60 mg/㎡ iv days 1,8 + 5-fluorouracil 500mg/㎡ iv days 1,8(cycled every 28 days for 3 cycles)"
16132313|NCT01917578|Drug|AC-P,TEC,AC,TC,TCH,CEF,TAC,CAF|"AC-P:Doxorubicin 60 mg/㎡ iv day 1 +Cyclophosphamide 600 mg/㎡ iv day 1(Cycled every 14 days for 4 cycles)→ Paclitaxel 175mg/㎡ by 3h iv infusion day 1(Cycled every 14 days for 4 cycles) or Paclitaxel 80mg/㎡ by 1h iv infusion weekly for 12 wks.
~TEC:Docetaxel 75 mg/㎡ iv day 1 + Epirubicin 75 mg/㎡ in day 1 + Cyclophosphamide 500 mg/㎡ iv day 1(Cycled every 21 days for 6 cycles)
~AC:Doxorubicin 60 mg/㎡ in day 1 + Cyclophosphamide 600 mg/㎡ iv day 1(Cycled every 21 days for 4 cycles)
~TC:Docetaxel 75 mg/㎡ iv day 1 + Cyclophosphamide 600 mg/㎡in day 1(Cycled every 21 days for 4 cycles)
~TCH:Docetaxel 75 mg/㎡ iv day 1 + Carboplatin AUC 6 iv day1(Cycled every 21 days for 6 cycles) + Trastuzumab 4 mg/kg iv wk 1 → Trastuzumab 2 mg/kg iv for 17 wks → Trastuzumab 6 mg/kg iv every 3 wks to complete 1 year.
~CEF:Cyclophosphamide 75 mg/㎡ po day 1-14 + Epirubicin 60 mg/㎡ iv days 1,8 + 5-fluorouracil 500mg/㎡ iv days 1,8(cycled every 28 days for 6 cycles)"
16132314|NCT01917552|Drug|capecitabine|capecitabine 1250 milligram (mg) / m² po bid (D1-14)
16132315|NCT01917539|Device|Sham Treatment|Sham light treatment will consist of applying the usual eye shields used for PLT, applying the usual skin gel to the facial region, and applying the cooling probe without application of pulsed light therapy treatment.
16132316|NCT01917539|Device|Pulsed Light Therapy|Light treatment will consist of applying eye shields used for PLT, applying the skin gel to the facial region, and applying the probe with application of pulsed light therapy treatment.
16132317|NCT01917526|Device|oxygen mask|
16132318|NCT01917526|Device|oxygen cannula|
16132319|NCT01917513|Device|G-EYE™ colonoscopy|G-EYE™ colonoscopy
16132320|NCT01917513|Device|Standard Colonoscopy|Standard Colonoscopy
16132321|NCT01917474|Dietary Supplement|low lipid diet|Patients will receive a diet of about 2000 kcal daily with no more than 20 % of the total energy coming from lipids, mainly from the monounsaturated olive oil
16132322|NCT01917474|Dietary Supplement|normal lipid diet|Patients will receive a diet of about 2000 kcal daily with 28 % of the total energy coming from lipids, mainly from the monounsaturated olive oil
16132323|NCT01917448|Drug|Morphine|spinal morphine 0.15 mg
16132324|NCT01917448|Other|control|Patient receive only local infiltration without spinal analgesia
16132325|NCT01917435|Device|video-stylet|
16132326|NCT01917435|Device|fiberoptic bronchoscope|
16132328|NCT01917409|Device|video-stylet|the device is to guide the nasotracheal tube into trachea
16132329|NCT01917396|Drug|Fleet enema|
16132330|NCT01917383|Drug|Trabodenoson|Ophthalmic eye drop
16132331|NCT01917383|Drug|Latanoprost|Ophthalmic eye drop
16132332|NCT01917383|Drug|Timolol|Ophthalmic eye drop
16132333|NCT01917370|Procedure|surgical treatment|all the patients in the study must have been treated by the surgery at the first time and have been confirmed as 'complete section' by the post-surgery radiological image.
16132334|NCT01917357|Biological|Quinvaxem in Uniject|
16132335|NCT01917357|Biological|Quinvaxem in single dose vials|
16132336|NCT01917344|Other|MRI|
16132339|NCT01917318|Drug|Iloperidone|"Subjects will receive oral iloperidone for 8 weeks. The first 2 weeks of treatment is called titration period and during this time the dose of iloperidone will be increased periodically from 1mg to a maximum of 8mg depending on response and tolerability.
~During the remaining 6 weeks of treatment, called stable dose period, the subjects will receive a stable dose of iloperidone(defined during titration period)"
16132340|NCT01917318|Drug|Placebo|During 8 weeks subjects will receive oral placebo
16132341|NCT01917305|Device|platform-shifted implant|
16132342|NCT01917292|Procedure|One-Stage Full-Mouth Disinfection|"Basic oral hygiene instructions
~Dental extractions will be performed (only in cases of teeth that could not be saved)
~Standard cycle of supragingival ultrasonic scaling and polishing
~Scaling and root planning after the administration of local anesthesia, four quadrants in one session
~Minocycline Hydrochloride Ointment (Periocline, OraPharma) were delivered locally into the periodontal pockets"
16132343|NCT01917292|Procedure|Periodontal care|"Basic oral hygiene instructions
~Standard cycle of supragingival ultrasonic scaling and polishing"
16132344|NCT01917279|Drug|Docetaxel plus Capecitabine|"Eligible patients will receive treatment with Capecibatine (1000 mg/ m2 twice daily D1-14 Q3W) plus docetaxel(75 mg/m2, D1,Q3W) for a maximum of 6 cycles, or be treated until disease progression, unacceptable toxicity or patient request for withdrawal, whichever occurs first. Each cycle is 3 weeks in duration.
~For the the patients with SD, PR or CR after initiate treatment phrase will enter into maintenance treatment phase."
16132345|NCT01917279|Drug|Intermittent Capecitabine|Capecitabine 1000 mg/m2 twice daily on days 1-14 of each 3-week cycle
16132346|NCT01917279|Drug|Metronomic Capecitabine|Capecitabine 500 mg three times daily on days 1-21 of each 3-week cycle
16132347|NCT01917253|Device|Standard Device for peripheral vein cannulation|
16132348|NCT01917253|Device|Long Catheters for peripheral vein cannulation|
16132349|NCT01917240|Other|Comprehensive Chromosome Screening|On day 5 or 6 of embryo development, all embryos will undergo a trophectoderm biopsy using the standardized technique, as according to standard laboratory protocol and without regard to study. Comprehensive Chromosome Screening (CCS) results will be available by the morning of day 6 if embryos are suitable for a fresh transfer which is the routine in our program.
16132350|NCT01917227|Behavioral|Video|
16132351|NCT01917214|Other|Sutent: Observational Study|Sutent oral therapy
16132352|NCT01917201|Procedure|IVUS-guided group|"The randomization on groups was completed in accordance with stents to be implanted: Xience Prime/Xience V, Promus Element, Resolute Integrity, Biomatrix Flex, Nobori, Orsiro. In each group randomization on subgroups of IVUS-guided implantation and non-IVUS in the ratio 2:1 was completed. After randomization it is carried out coronary stenting under IVUS-control: a choice of length and diameter of stent - according to IVUS data. After the completion of implantation and postdilatation of stents the control IVUS is being used. If criteria of optimal implantation were not achieved, additional impact is being made: larger balloon, higher pressure, sufficient time of impact. In case of an additional impact the repeated control IVUS is being completed and the following results are being fixed. After control IVUS the OCT procedure is carried out. During OCT possible problems corresponding to stenting are being fixed. An additional impact based on OCT data is not being used."
16132353|NCT01917201|Procedure|Non-IVUS group|"The randomization on groups was completed in accordance with stents to be implanted: Xience Prime/Xience V, Promus Element, Resolute Integrity, Biomatrix Flex, Nobori, Orsiro. In each group randomization on subgroups of IVUS-guided implantation and non-IVUS in the ratio 2:1 was completed. After randomization it is carried out coronary stenting under angiography control. After postdilatation control OCT is carried out. During OCT possible problems corresponding to stenting (malapposed struts, separate beams, a prolapse of fiber, microthrombosis) are being fixed. An additional impact based on OCT data is not being used."
16132354|NCT01917188|Behavioral|Full simulation and education|
16132355|NCT01917188|Behavioral|See simulation room, usual education|
16132356|NCT01917162|Device|Nelfilcon A contact lens|Soft contact lens CE-marked for daily disposable wear.
16132357|NCT01917162|Device|UltraFilcon B contact lens|Silicone hydrogel soft contact lens CE-marked for daily disposable wear. Private-label versions may be used.
16132358|NCT01917149|Drug|Benazepril|
16132359|NCT01917149|Drug|Valsartan|
16132360|NCT01917149|Drug|Metoprolol|
16132361|NCT01917136|Drug|11C-acetate|For each PET/CT imaging session subjects will receive a 15-25 millicurie intravenous injection of 11C-acetate
16132362|NCT01917136|Drug|[18F]Fluoro-2-deoxy-2-D-glucose|For each PET/CT imaging session subjects will receive a 10 millicurie injection of 18F-FDG
16132363|NCT01917136|Other|Cardiac MRI|Cardiac MRI is performed at 6 months to measure any change in structure and function of the treatment groups.
16132364|NCT01917123|Drug|L-Citrulline malate|L-Citrulline malate as a 1gr powder agent, twice a day, for 2 weeks and placebo as a 1gr powder agent of O.R.S, twice a day,for 2 weeks
16132365|NCT01917110|Device|omafilcon A|
16132366|NCT01917110|Device|Spectacle|
16132367|NCT01917097|Drug|Dexmedetomidine|
16132368|NCT01917084|Other|Passive range of motion (ROM) exercise|After their Norwood surgery, stable subjects will undergo passive ROM exercise therapy for up to 21 consecutive days or until hospital discharge, whichever comes first. Subjects will have completed the study after their anthropometric measurements are collected at 3 months of age
16132369|NCT01917071|Other|thoracic spine manipulation|a manual technique applied to the mid back to promote motion
16132497|NCT01916044|Other|Ultrasound|Measure of Uterine Segment by Ultrasound
16132370|NCT01917058|Drug|Abatacept|"This will be a randomized double blind placebo controlled study. Patients will be randomly assigned to abatacept or placebo in a 1:1 ratio based on a computer generated randomization list. The list will be generated prior to study initiation. Based on the randomization list, patients will be assigned to treatment vs. vehicle (provided by BMS) in the order in which they are enrolled. The assignment will be made by study personnel who are not involved in making clinical assessments or evaluations. The patient and the assessing physicians will remain blinded to the treatment assignment for the duration of the study.
~Patients will be treated with abatacept 125mg SC self-administered each week. Treatment will be continued for 6 months to provide adequate time to assess the short-term efficacy and safety of abatacept in patients with alopecia areata. Patients will then be followed for an additional 6 months to assess the timing and incidence of relapse."
16132371|NCT01917058|Drug|placebo|
16132372|NCT01917045|Drug|Sufentanil (R30730, brand name Sufenta)|sufentanil 1ug/ml
16132373|NCT01917045|Drug|Sufentanil (R30730, brand name Sufenta) + Morphine|sufentanil 0.5ug/ml+morphine 0.25mg/ml
16132374|NCT01917045|Drug|Morphine|morphine 0. 5mg/ml
16132375|NCT01917032|Dietary Supplement|Sachets containing a blend of micronutrients in powder form (Iron, Zinc, Folic Acid, Vitamin A and C), sprinkled onto home made food|1 g orally on weekdays during 11 weeks
16132376|NCT01917032|Dietary Supplement|placebo|
16132377|NCT01917019|Drug|Placebo|matching placebo tablets
16132378|NCT01917019|Drug|BIIB041 (fampridine)|fampridine prolonged-release tablets
16132379|NCT01917006|Drug|OnabotulinumtoxinA|OnabotulinumtoxinA injected into specified muscle per protocol on Day 1.
16132380|NCT01917006|Drug|Normal Saline|Placebo (normal saline) injected into specified muscle per protocol on Day 1.
16132381|NCT01916993|Drug|NBI-98854 50 mg capsule|
16132382|NCT01916980|Drug|Desloratadine 5 mg|Desloratadine 5 mg/day: one 5-mg tablet taken orally once daily in the evening for up to 12 weeks (Desloratadine 10 mg/day: two 5-mg tablets taken orally once daily in the evening for up to 8 weeks)
16132383|NCT01916967|Drug|Desloratadine|Desloratadine 5 mg tablets, given orally, once daily in the evening for 2 weeks
16132384|NCT01916967|Drug|Placebo|Placebo tablets, given orally, once daily in the evening for 2 weeks
16132385|NCT01916954|Drug|3-day artemether-lumefantrine|
16132386|NCT01916954|Drug|5-day artemether-lumefantrine|
16132387|NCT01916941|Drug|Prazosin|
16132388|NCT01916941|Drug|Placebo|
16132389|NCT01916915|Drug|Tramadol infusion via wound catheter|
16132390|NCT01916915|Drug|Levobupivacaine|
16132391|NCT01916902|Drug|Ticagrelor- Delayed Administration|Subjects are randomized to receive ticagrelor immediately after enrollment versus at the time of cardiac catheterization. OCT is performed prior to and after coronary artery stenting.
16132392|NCT01916902|Drug|Ticagrelor- Immediate Administration|Subjects are randomized to receive ticagrelor immediately after enrollment versus at the time of cardiac catheterization. OCT is performed prior to and after coronary artery stenting.
16132393|NCT01916902|Procedure|Optical Coherence Tomography|
16132394|NCT01916889|Other|RACY test|
16132395|NCT01916876|Other|Integrated medical follow-up package|"At discharge, patients will receive a discharge plan by their attending caregiver.
~On day 3 they will be contacted telephonically to:
~i) Discuss their discharge diagnosis and medications ii) Arrange specialist clinic follow-up booking for 2 weeks iii) Reemphasise drug compliance
~Reminders via SMS to attend there OPD appointment(s)
~Medical out-patient review at 2-weeks and 6 weeks if required
~Medical telephonic hot-line for advice"
16132396|NCT01916863|Drug|LX4211 400 mg|
16132397|NCT01916863|Drug|canagliflozin 300 mg|
16132398|NCT01916863|Drug|LX4211 Placebo|
16132399|NCT01916850|Drug|LX4211 400 mg|
16132400|NCT01916850|Drug|LX4211 800 mg|
16132401|NCT01916850|Drug|LX4211 Placebo|
16132402|NCT01916837|Other|Sampling of tumor tissue|Fresh tumor specimens were sampled prior to adding any fixative and within one hour of breast cancer surgery
16132403|NCT01916837|Other|Sampling of tumor tissue after breast cancer surgery|Fresh tumor specimens were sampled prior to adding any fixative and within one hour of breast cancer surgery
16132404|NCT01916837|Procedure|Sampling of tumor tissue after breast cancer surgery|Fresh tumor specimens were sampled prior to adding any fixative and within one hour of surgery
16132405|NCT01916824|Drug|Any FDA Approved Antidepressant|Any FDA-approved antidepressant prescribed within standard dose range to treat Major Depressive Disorder will be taken for 6 weeks. Psychiatric follow-up will be performed during the study participation. At the end of the study, these participants will receive assistance in transitioning their care to another provider, depending on their individual circumstances.
16132406|NCT01916798|Drug|Intralipid infusion|IV infusion of 250 ml of intralipid 20% solution at the day of Ovum pick up & another dose at the day of embryo Transfer.
16132407|NCT01916785|Drug|Dasatinib|Dasatinib is a multitargeted tyrosine kinase inhibitor with a 300-fold more potent activity on the BCR-ABL tyrosine kinase in vitro compared to imatinib mesylate
16132408|NCT01916772|Other|no interventions|no interventions
16132409|NCT01916759|Drug|Seasonal trivalent inactivated influenza vaccine (Vaxigrip®)|Administer seasonal trivalent inactivated influenza vaccine (Vaxigrip®) and collect blood specimens at 0, 1, 3, 7, 14, 28 and 100 days following vaccination.
16132410|NCT01916746|Procedure|transvaginal resection of pregnancy tissue|Patient were under general anaesthesia, placed in a dorsal lithotomy position and the bladder emptied. Expose, grasp and traction the cervix. And adrenaline (600 ug/l; 10-20 ml) was injected submucosally at the level of the cervicovaginal junction. An incision was made at the anterior cervicovaginal junction, and the bladder was dissected away until the anterior peritoneal reflection was identified. The anterior drawing hook was inserted into the vaginal incision to retract the bladder upwards. The CSP was identified as a'purple bulge' located in the anterior part of the lower uterine segment. A transverse incision was made over the most prominent area of the bulge. Ectopic pregnancy tissue inside the bulge was removed, and suction curettage through the incision on the uterus isthmus was subsequently performed. The edges of the incision were trimmed with scissors, and the myometrial and vaginal defects were closed with a continuous locking suture using 2-0 absorbable sutures.
16132498|NCT01916031|Behavioral|Education|
16132499|NCT01916018|Other|Clinical and radiologic exams and blood samples|
16132500|NCT01916005|Device|18F-FDG PET/CT|
16132411|NCT01916733|Drug|standard insulin protocol post-op (continuous IV insulin)|concurrent, matched cohort study of moderate postoperative glucose control in patients undergoing LEB or open AAA repair.Propensity score matching is a statistical method used to reduce the confounding effects of covariates in an observational (non-randomized) study. In practice we will select a number of variables that impact wound infection; age, gender, diabetic and non-diabetic populations, renal insufficiency (defined at creatinine ≥1.8) and indication for surgery (claudication or critical limb ischemia with rest pain or tissue loss or open AAA repair); and chose a group of patients in the Vascular Study Group matched for these variables who have not been treated with an insulin infusion). Consecutive patients undergoing elective open AAA repair or infrainguinal LEB for claudication and critical limb ischemia will be invited to enroll in the study.
16132412|NCT01916720|Drug|SB-480848 40 mg|Study Drug
16132413|NCT01916720|Drug|SB-480848 80 mg|Study Drug
16132414|NCT01916720|Drug|Placebo|Study Drug
16132415|NCT01916707|Drug|Dosing of enoxaparin for VTE prophylaxis|
16132416|NCT01916694|Device|Blue tooth enabled glucose meter with smart phone application|
16132417|NCT01916694|Behavioral|Self home blood glucose monitoring|Fingerprick testing of blood glucose levels before and 2 hours after meals
16132418|NCT01916681|Device|Cervical Foley & Misoprostol|A cervical foley combined with misoprostol will be used to induce the patient.
16132419|NCT01916681|Drug|Misoprostol Alone|Misoprostol will be used alone to induce the patient
16132420|NCT01916681|Device|Cervical Foley Alone|A cervical foley alone will be used to induce the patient
16132421|NCT01916681|Device|Cervical Foley & Pitocin|A cervical foley combined with pitocin will be used to induce the patient
16132422|NCT01916655|Behavioral|Self-Management Care|Provision of sleep apnea-specific self-management education and support for those who are prescribed CPAP therapy
16132423|NCT01916655|Behavioral|Self-Management Mobile Care|Provision of sleep apnea-specific self-management education and support for those who are prescribed CPAP therapy via mobile phone
16132424|NCT01916655|Behavioral|Usual Care|standard and typical CPAP educational and support protocol; is the base level education and support that is provided in the other two interventions in this study.
16132425|NCT01916642|Drug|Lidocaine 1mg/kg|The total dosage of Etomidate needed for induction of anesthesia is recorded at last.
16132426|NCT01916642|Drug|Lidocaine 1.5mg/kg|same as other
16132427|NCT01916642|Drug|Lidocaine 2mg/kg|same as other
16132428|NCT01916642|Drug|Lidocaine 2.5mg/kg|same as other
16132429|NCT01916629|Drug|Photocil for Psoriasis|Photocil for Psoriasis
16132430|NCT01916629|Other|Placebo - Sunscreen (SPF 2)|Placebo - Sunscreen (SPF 2)
16132431|NCT01916616|Behavioral|Four therapy sessions with a psychologist utilizing cognitive-behavioral therapy techniques|At the four therapy sessions, subjects will work with the psychologist to identify the triggers of their VCD episodes, learn to self-monitor symptoms and reactions, and be taught breathing retraining/relaxation techniques. The goal is to decrease patterns of subjects' thinking or behaviors that exacerbate distress from VCD symptoms.
16132432|NCT01916603|Behavioral|Normative Intervention|Diet and physical activity counselling-support and breastfeeding promotion till 12 months postpartum
16132433|NCT01916590|Drug|Bupivicaine|After surgery before the patient is discharged home their femoral catheter will then be connected to the home pain pump filled with bupivacaine 0.25% solution (without epinephrine), and the infusion will be started at 6 ml/hr. gh the catheter.
16132434|NCT01916590|Drug|placebo|
16132435|NCT01916577|Drug|Plerixafor mobilization of autologous CD117 stem cells|Peripheral mobilization of autologous CD117+ stem cells from the bone marrow in patients awaiting lung transplantation versus normal controls
16132436|NCT01916564|Other|Split-dose|"2 tablets of bisacodyl 5 mg at 8 p.m. two days before colonoscopy
~Low fibre diet and 2 tablets of bisacodyl 5 mg at 8 p.m. on the day before colonoscopy
~1-L PEG-ELS between 8 p.m. and 8.30 p.m. on the day before and 1-L PEG-ELS between 5.30 a.m. and 6 a.m. on the day of colonoscopy"
16132437|NCT01916564|Other|Same-morning whole-dose|"2 tablets of bisacodyl 5 mg at 8 p.m. two days before colonoscopy
~Low fibre diet and 2 tablets of bisacodyl 5 mg at 8 p.m. on the day before colonoscopy
~2-L PEG-ELS between 5 a.m. and 6 a.m. on the day of colonoscopy"
16132438|NCT01916525|Behavioral|Exercise based cardiac rehabilitation|The cost-effectiveness between the exercise training vs. control groups
16132439|NCT01916499|Other|3 tesla magnetic resonance imaging findings; coronary artery status|
16132440|NCT01916499|Other|3 tesla magnetic resonance imaging findings; ventricular function and morphology|
16132441|NCT01916486|Behavioral|Exercise training|The EX Program will provide objective progression in the guided exercises of each participant.
16132442|NCT01916486|Behavioral|Complex mental and social activities|The Cog-Plus Program will engage participants in activities promoting cognitive function and socialization.
16132443|NCT01916486|Behavioral|Control: stretching and relaxation program|The CON Program consist of stretches, deep breathing and relaxation techniques, general posture education, and general core control exercises in the sitting position.
16132444|NCT01916473|Other|Epidural analgesia|Epidural analgesia is provided with ropvacaine 0.2% given 6 hourly
16132445|NCT01916473|Other|Continuous wound infusion|Continuous wound infusion via catheter
16132446|NCT01916460|Procedure|Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)|After the subjects meet the criteria for enrollment in the study, gastroparetic patients will undergo linear EUS examination of the stomach wall one day prior to their surgery to obtain single or multiple core biopsies of the stomach body wall using the 19-gauge core biopsy needle under EUS guidance. The pathologist will be in the room to assess the adequacy of the sample after each pass. Once the pathologist deemed that the obtained sample is sufficient, the procedure will be terminated
16132447|NCT01916447|Drug|TAS-102|Escalating doses (20-35 mg/m2/dose, based on tolerability), orally, twice daily on days 1-5 of each 14-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.
16132448|NCT01916447|Drug|CPT-11|Escalating doses (30-minute infusion of 120-180 mg/m2/dose, based on tolerability), IV (in the vein) on Day 1 of each 14-day treatment cycle. Number of cycles: until at least one of the discontinuation criteria is met.
16132449|NCT01916447|Drug|Bevacizumab|Dose (infusion of 5 mg/kg administered per site standard practice), IV (in the vein) on Day 1 of each 14-day treatment cycle. Number of cycles: until at least one of the discontinuation criteria is met.
16132450|NCT01916434|Other|High PUFA Salmon Fillets|High EPA/DHA levels in feed and in salmon fillets (~15% of total feed fatty acids, equal to wild salmon), 2 salmon fillets per week for 18 weeks, on top of habitual fish consumption.
16132451|NCT01916434|Other|Sustainable PUFA salmon|'Sustainable' levels of EPA/DHA in feed and in salmon fillets (~6-8% of total feed fatty acids), 2 salmon fillets per week for 18 weeks, on top of habitual fish consumption.
16132452|NCT01916434|Other|No salmon|The placebo group will continue to consume their habitual diet.
16132453|NCT01916421|Procedure|Endoscopic Ultrasound Fine Needle Aspiration (EUS-FNA)|
16132454|NCT01916408|Drug|Wobenzym plus|3 x 4 tablets of the study medication each day for the one week before and 3 x 2 tablets of the study medication each day for the two weeks after the marathon.
16132455|NCT01916408|Drug|PL 1|3 x 4 tablets of the study medication each day for the one week before and 3 x 2 tablets of the study medication each day for the two weeks after the marathon.
16132456|NCT01916395|Drug|sumatriptan and Treximet|sumatriptan 100mg tablet when migraine is moderate or severe in intensity. Treximet 85/500mg tablet when migraine is moderate or severe in intensity.
16132457|NCT01916382|Drug|Nitisinone|drug
16132458|NCT01916369|Biological|CTX DP|Single dose treatment consisting of 10 injections (20, 50 or 80 million cells) into the gastrocnemius muscle near to the damaged area
16132459|NCT01916356|Other|educational video|Educational video covering topics of basic reproductive biology, infertility etiologies, risk factors, treatments and common myths.
16132460|NCT01916343|Procedure|Study Laparoscopic Curriculum|
16132461|NCT01916317|Drug|0.5% lignocaine 60mM|
16132462|NCT01916304|Drug|Levothyroxine sodium new formulation|Levothyroxine tablets
16132463|NCT01916291|Drug|Propess insertion group|
16132464|NCT01916278|Device|Emervel Lips Lidocaine|
16132465|NCT01916278|Device|Juvéderma Volbella with Lidocaine|
16132466|NCT01916265|Drug|Glucagon|
16132467|NCT01916252|Drug|bortezomib (Velcade ®)|
16132468|NCT01916252|Drug|lenalidomide (Revlimid®)|
16132469|NCT01916252|Drug|busulfan (Busilvex ®)|
16132470|NCT01916252|Drug|Dexamethasone acetate|
16132471|NCT01916252|Drug|Melphalan|
16132472|NCT01916239|Dietary Supplement|Standard pomegranate extract formulation|Standard pomegranate extract formulation containing 20% punicalagin
16132473|NCT01916239|Dietary Supplement|Pomegranate extract formulation-1|New pomegranate extract formulation-1
16132474|NCT01916239|Dietary Supplement|Pomegranate extract formulation-2|New pomegranate extract formulation-2
16132475|NCT01916226|Drug|FPNS|Bottled, 16 gm net fill weight for 120 metered sprays with unit dose strength of 50 mcg per spray.
16132476|NCT01916226|Drug|FPNS Placebo|Bottled placebo nasal spray (vehicle for Fluticasone propionate aqueous nasal spray), 16 gm net fill weight for 120 metered sprays.
16132477|NCT01916226|Drug|Cetirizine|Over-encapsulated Cetirizine tablet with unit dose strength of 10 mg in High Density Poly Ethylene Bottles (20 count per bottle).
16132478|NCT01916226|Drug|Cetirizine Placebo|Over-encapsulated Cetirizine matching tablet High Density Poly Ethylene Bottles (20 count per bottle).
16132479|NCT01916213|Procedure|PICSI|If the oocytes are randomized to ICSI during the retrieval they will be ordered by the 1,4,5 8th best oocyte and PICSI to the 2,3, 6 7th best oocytes or the reverse if PICSI is selected. If one cohort is superior that cohort should be chosen by the blinded physician and the alternate cohort frozen or discarded based on their quality. This will ensure that the couple will always have the opportunity to have good quality embryo transferred regardless of how they are randomized. If there are no good quality embryos in the selected cycle we will consider it a failed transfer for that cycle and we will transfer the good quality embryos from the non- selected group as a fresh embryo transfer. For example if a couple is randomized to ICSI and all the ICSI embryos are poor quality but the PICSI embryos are good quality we will consider it a failed ICSI transfer and transfer the PICSI embryos as a fresh embryo transfer.
16132480|NCT01916200|Drug|Paroxetine CR|Paroxetine CR will be provided by GlaxoSmithKline (GSK) and be available as 12.5 mg over-encapsulated tablets with the research use only label outside the package. Paroxetine CR should be administered as a single daily dose, with or without food. The recommended initial dose is 25 mg/day. Patients were dosed in a range of 25 mg to 62.5 mg/day in the clinical trials demonstrating the effectiveness of paroxetine CR in the treatment of major depressive disorder. As with all drugs effective in the treatment of major depressive disorder, the full effect may be delayed. Some patients not responding to a 25-mg dose may benefit from dose increases, in 12.5 mg/day increments, up to a maximum of 62.5 mg/day. Dose changes should occur at intervals of at least 1 week.
16132481|NCT01916187|Drug|Imetelstat|
16132482|NCT01916174|Drug|insulin degludec/liraglutide|Subject will receive a single injection (s.c.) of IDegLira B5
16132483|NCT01916174|Drug|insulin degludec/liraglutide|Subject will receive a single injection (s.c.) of IDegLira V2
16132484|NCT01916161|Other|Questionnaire|
16132485|NCT01916148|Drug|18F-DOPA|18F-DOPA is a PET scan radiotracer.
16132486|NCT01916135|Radiation|[18F]-SKI-249380|
16132487|NCT01916135|Procedure|PET/CT scan|PET scans will be performed immediately, at approximately 90 minutes, and optionally at approximately 3 hours after injection of the radiotracer. This includes an initial 30-minute PET scanning period, performed. At each subsequent time-point, a 30 minute axial body image is acquired. Images will be acquired on a state-of-the-art PET-CT scanner. A 30-45 minute scanning time-period is typical for clinical PET studies. A low-dose CT will be obtained immediately-prior to PET imaging, at each time-point.
16132488|NCT01916135|Other|Blood draws|Blood will be drawn at the multiple time points for pharmacokinetic & metabolite analyses of 18F-SKI-249380. We anticipate these time points to be approximately 1, 5, 15, 30, and 90 minutes and 3 hours (optional), post-injection.
16132489|NCT01916122|Drug|Fluorestradiol (FES)|
16132490|NCT01916122|Procedure|PET/CT Imaging|
16132491|NCT01916109|Drug|Gemcitabine|
16132492|NCT01916109|Drug|Carboplatin|
16132493|NCT01916109|Drug|Panitumumab|
16132494|NCT01916109|Procedure|radical cystectomy|
16132495|NCT01916096|Device|Delica Device|
16132496|NCT01916057|Device|18F-FDG PET Scan|to determine whether F18 fluorodeoxyglucose (18F-FDG) positron-emission tomography scan (PET scan) is useful for the therapy strategy of hepatosplenic candidiasis.
16132501|NCT01915992|Other|blood samples|
16132503|NCT01915979|Drug|Celestone cronodose (Bethametasone)|
16132504|NCT01915966|Dietary Supplement|Cardamom, ginger and orange juice gelatin|Patients will receive the recipe of the gelatin, with detailed instructions to prepare it at home, and the necessary ingredients for the gelatin. If necessary, they will be helped in the preparation of an initial batch that should last for one week of treatment. Patients will be instructed to consume the gelatin candy as necessary to alleviate the dry mouth sensation
16132505|NCT01915966|Dietary Supplement|Camomile infusion with lemon juice|Patients will receive instructions to prepare the infusion at home, and the necessary ingredients. Patients will be instructed to ingest the infusion as necessary to alleviate the dry mouth sensation.
16132506|NCT01915940|Drug|Bimatoprost|Bimatoprost ocular insert
16132507|NCT01915940|Drug|Timolol 0.5%|Timolol 0.5% solution
16132508|NCT01915940|Drug|Placebo Eye Drops|Placebo topical eye drops
16132509|NCT01915940|Device|Placebo Ocular Insert|Ocular insert without any active drug
16132510|NCT01915927|Drug|MSC-AFP|
16132511|NCT01915914|Drug|Fluticasone propionate|All subjects receive FP 0.05% cream twice daily up to 4 weeks to all affected sites and any newly occurring sites in ACUTE phase. After randomization in MAINTENANCE phase, subjects either receive emollient (Physiogel) twice daily extendedly plus FP 0.05% cream once daily twice a week to all healed sites and any newly occurring sites (Group A), or emollient (Physiogel) twice daily extendedly (Group B), up to 20 weeks. In FOLLOW-UP phase, all subjects apply emollient (Physiogel) twice daily up to 12 weeks.
16132512|NCT01915901|Drug|bismuth subsalicylate (Pepto-Bismol®)|524 mg bismuth subsalicylate twice a day (BID)
16132513|NCT01915901|Drug|matching placebo (bismuth subsalicylate)|placebo twice a day (BID)
16132514|NCT01915901|Drug|dimethyl fumarate (DMF)|dimethyl fumarate (DMF) twice a day (BID)
16132515|NCT01915888|Other|Data interpretation|The data collected for each group will be fully de-identified, interpreted and analysed separately for the 2 databases (MarketScan Commercial and MarketScan Medicaid).
16132516|NCT01915875|Other|sophrology sessions at home|The sophrology is a dynamic method of physical and psychical relaxation
16132517|NCT01915849|Drug|LIK066|LIK066 15 mg, 50 mg and 150 mg
16132518|NCT01915849|Drug|Placebo|
16132519|NCT01915836|Other|web-based video game (Quit IT)|
16132520|NCT01915836|Behavioral|Questionnaires|
16132521|NCT01915836|Behavioral|Evaluation Interview|
16132522|NCT01915823|Drug|azelastine hydrochloride and fluticasone propionate|
16132523|NCT01915823|Drug|Dymista vehicle|
16132524|NCT01915810|Behavioral|Exercise Intervention|Complete SCwPA intervention
16132525|NCT01915810|Other|Laboratory Biomarker Analysis|Correlative studies
16132526|NCT01915810|Drug|Nicotine Patch|Receive nicotine patch
16132527|NCT01915810|Other|Questionnaire Administration|Ancillary studies
16132528|NCT01915810|Other|Tobacco Cessation Counseling|Receive smoking cessation counseling
16132529|NCT01915797|Other|blood and tumor samples|all tumor pathology associated with anomaly of development
16132530|NCT01915784|Device|Genuair®|Inhaler with placebo only. Once daily, for 14 days.
16132531|NCT01915784|Device|Breezhaler®|Inhaler with placebo only. Once daily, for 14 days.
16132532|NCT01915771|Drug|lomitapide|20 mg dose
16132533|NCT01915758|Drug|clindamycin1%/tretinoin 0.025% gel|clindamycin1%/tretinoin 0.025% gel
16132534|NCT01915758|Drug|vehicle gel|vehicle gel
16132535|NCT01915745|Other|Use of SMS|Patients receive 3 SMS (at 15 days, 5 weeks and 3 months) after consulting in Emergency Department. Then they are called during 10 minutes at 6 months to check if bone densitometry will be performed and if antiosteoporotic treatment will be initiated.
16132536|NCT01915732|Drug|Duac™Once Daily Gel|1% clindamycin as clindamycin phosphate and 5% benzoyl peroxide
16132537|NCT01915732|Drug|1% clindamycin phosphate gel|1% clindamycin as clindamycin phosphate
16132538|NCT01915719|Procedure|Early non invasive ventilation|
16132539|NCT01915719|Procedure|Oxygen therapy only|
16132540|NCT01915706|Procedure|Ripcord removal|Patients randomized to intervention will have their ripcords removed in clinic at post-operative week 3. Ripcord removal will be performed by study PI at the slit lamp with standard of care sterile technique and topical/local anesthesia. Patients will be monitored 30 minutes following ripcord removal for intraocular pressure as well as complications.
16132541|NCT01915693|Radiation|Radiotherapy|External beam radiotherapy (EBRT) delivering a tumour absorbed dose of 20Gy in 5 fractions or 30Gy in 10 fractions.
16132542|NCT01915667|Drug|200 mg GLPG0634 as capsules, fasted|single oral dose of 200 mg GLPG0634 given as capsules in fasted condition
16132543|NCT01915667|Drug|200 mg GLPG0634 as tablets, fasted|single oral dose of 200 mg GLPG0634 given as tablets in fasted condition
16132544|NCT01915667|Drug|200 mg GLPG0634 as tablets, fed|single oral dose of 200 mg GLPG0634 given as tablets in fed condition
16132545|NCT01915654|Procedure|study population|Population of patients undergoing cardiac surgery between December 2008 and May 2009, with pellets transfused RBCs stored for less than 14 days
16132546|NCT01915641|Device|CPAP|Randomized those patients to group A and group B group A : CPAP treatment with optimal pressure for 1 month, repeat measurement change CPAP treatment to sham pressure 5cm H2O for 1 month, repeat measurement group B : CPAP treatment with sham pressure for 1 month, repeat measurement change CPAP treatment with optimal pressure for 1 month, repeat measurement
16132547|NCT01915628|Device|BioMatrix Flex|Percutaneous coronary intervention
16132548|NCT01915615|Other|None - this is an observational study|None - this is an observational study
16132549|NCT01915602|Drug|Refametinib (BAY86-9766)|Patients will receive refametinib 50 mg (2x20 mg + 1x10mg capsules or 50 mg tablets) bid
16132550|NCT01915602|Drug|Sorafenib (BAY43-9006)|Patients will receive sorafenib 400 mg (2 x 200 mg tablets) bid.
16132551|NCT01915589|Drug|Refametinib (BAY86-9766)|All patients who meet the entry criteria will receive refametinib 50 mg (2x20 mg + 1x10 mg capsules or 50 mg tablet) bid.
16132552|NCT01915576|Drug|BAY1125976|Oral administration once daily. Starting dose is 10 mg and will be escalated depending on any dose-limiting toxicities
16132553|NCT01915576|Drug|BAY1125976|Oral administration twice daily. Starting dose is 40mg twice daily and will be escalated depending on any dose-limiting toxicities
16132959|NCT01912365|Procedure|Long Arm Splint|
16132554|NCT01915576|Drug|BAY1125976|Oral administration of the defined MTD which shows optimal safety, PK profile, PD target inhibition and preliminary efficacy (once daily or twice daily) in different patient groups
16132555|NCT01915563|Procedure|REST|After a SBT patients will be extubated as usual or reconnected to mechanical ventilation for 60 min before extubation.
16132556|NCT01915550|Drug|Metformin|
16132557|NCT01915550|Drug|Humulin Insulin Mixtard|
16132558|NCT01915537|Drug|Infliximab group|Infliximab with MTX treatment: Infliximab 3mg/kg at week 0, 2, 6 and then once every 8 weeks, MTX>7.5mg per week. To observe the results at week 14, 30, 54 and 102 after 6 times IFX treatment. It recommended that continue to receiving IFX treatment after remission for a period of time in good economic condition patients while receiving MTX with HCQ or LEF in poor economic condition patients.
16132559|NCT01915537|Drug|Classic DMARDs treatment group|"Classic DMARDs treatment: combination of 2 or 3 drugs, 2-drugs combination is MTX with LEF or Thunder God Vine, 3-drugs combination is MTX with HCQ and LEF or Thunder God Vine for total 30 weeks.
~Effective dose: MTX: 10-15mg per week; LEF: 20mg per day; HCQ: 200-400 mg per day; Thunder God Vine: 40-60 mg per day; It recommended that the maintain regimen is MTX with HCQ or LEF after remission for a period of time."
16132560|NCT01915524|Biological|CV9202|Intradermal injection of CV9202
16132561|NCT01915524|Radiation|local radiation|Radiotherapy will be administered in 4 daily fractions of 5 GY each to be administered within one week
16132562|NCT01915498|Drug|Enasidenib|Enasidenib tablets administered orally every day of 28-day treatment cycles until disease progression or unacceptable toxicities.
16132563|NCT01915485|Radiation|Lu 177|Patients will be submitted to 4 cycles of 177-Lu with 200mCi each
16132564|NCT01915472|Drug|IMMU 130|This is a Phase II, open-label study of IMMU-130 administered every 14 days for a period of 24 weeks to patients with metastatic colorectal cancer who have been previously treated with at least one prior irinotecan-containing regimen.
16132565|NCT01915459|Biological|Botulinum toxin type A(Botulax®)|IM, total dose of 360 Units at wrist flexor, elbow flexor, finger flexor, and thumb flexor based on muscle tone
16132566|NCT01915459|Biological|Botulinum toxin type A(Botox®)|
16132567|NCT01915433|Other|Wahls Paleo Plus|The study diet is based upon a Paleolithic Diet, also known as a Hunter Gatherer Diet, which exceeds the recommended daily allowance of water soluble vitamins and minerals 1.5 to 8 fold and improves lipids, inflammatory biomarkers and blood pressure. The study diet is further structured to be a low in carbohydrate and high in fat but still ensure consumption of the specific micronutrients important to optimal brain function. This diet is designed to induce a low level nutritional ketosis.
16132568|NCT01915433|Other|Wahls Diet|The study diet is based upon a Paleolithic Diet, also known as a Hunter Gatherer Diet, which exceeds the recommended daily allowance of water soluble vitamins and minerals 1.5 to 8 fold and improves lipids, inflammatory biomarkers and blood pressure. The study diet is further structured to be a low glycemic diet and also ensure consumption of the specific micronutrients important to optimal brain function.
16132569|NCT01915381|Other|multimodal intervention|All subjects received a multimodal intervention consist in a multimodal program with an educational approach, where therapist advice about benefits of PA during the exercises, to promote PA with brochure-based decalogue
16132570|NCT01915368|Behavioral|Stroke Management Program (SMP)|Participants will have usual care, and in addition, be provided with periodic information about their progress in the area of mobility using specialized activity monitors
16132571|NCT01915368|Behavioral|Stroke Monitoring Program (SMonP)|Participants will have usual care, and in addition, be progressed according to customized protocols using feedback from specialized activity monitors
16132572|NCT01915368|Behavioral|Stroke Supplementary Program (SSP)|Participants will have usual care, and in addition, will receive the same as the Stroke Monitoring Group, and also receive one additional hour of daily (5 times per week) physical exercise
16132573|NCT01915355|Device|Pulsed Dye Laser for the treatment of nail fungus|The purpose of this research is to investigate the use of the Candela V-beam Pulsed Dye Laser for the treatment of onychomycosis, a common nail fungus.
16132574|NCT01915342|Device|Focal muscular vibration|
16132575|NCT01915329|Device|RSS (repetitive sensory stimulation)|"RSS is a high frequency electrical stimulation protocol delivered to the peripheral nerves (median and ulnar nerve) of the hand. The signals are generated by a TENS-stimulator and are conveyed to each finger of the hand via a custom-made hand-shaped device with conductive contacts at each fingertip and at the palmar base.
~In case of the sham-stimulation no pulses are transmitted."
16132576|NCT01915329|Device|SHAM-RSS|The same device as in the RSS intervention is used, but no electrical stimuli are transmitted.
16132577|NCT01915316|Other|prostate biopsy|Measurements of Zinc concentration along fresh Specimens taken during Trans-Perineal saturated repeat Prostate Biopsy before Specimens are sent to Pathology.
16132578|NCT01915303|Drug|Pasireotide with or without cabergoline|The trial consisted of Pasireotide-untreated patients who started pasireotide 0.6mg twice a day for 8 weeks. If biochemical control was not achieved by the end of the 8 weeks, and the 0.6mg dose is well-tolerated, the dose was increased to 0.9mg twice a day for another 8 weeks. If biochemical control is not achieved, cabergoline was added and patients began combination treatment with cabergoline at the starting dose of 0.5mg once a day for 8 weeks. If biochemical control is still not achieved at the end of the third 8 week period, the dose of cabergoline was increased to 1.0mg once a day. Patients could also immediately start the combination treatment by adding cabergoline 0.5mg once a day at study entry to their current maximal tolerated dose of pasireotide. Patients continued with the combination treatment for 8 weeks. If biochemical control was not not achieved by the end of the 8 week period, the dose of cabergoline was increased to 1mg once a day.
16132579|NCT01915277|Drug|Dexmedetomidine|
16132580|NCT01915264|Drug|Acarbose/Metformin (Glucobay M, BAY81-9783)|Acarbose (25/50mg) and Metformin (500mg) in fixed dose combination.
16132583|NCT01915199|Other|Intensive Care|Comprehensive intervention on hypertension through optimization of drug therapy, introduction of home blood pressure monitoring, and lifestyle guidance
16132960|NCT01912352|Drug|Methylphenidate|
16132584|NCT01915186|Dietary Supplement|Dihydroepiandrosterone (DHEA)|DHEA capsules are given at 25mg 3 times a day for 12 weeks
16132585|NCT01915173|Drug|Supplement|Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C
16132586|NCT01915173|Drug|Placebo|Lactose tablets
16132587|NCT01915173|Behavioral|Expanded Interview|
16132588|NCT01915173|Behavioral|Standard Interview|
16132589|NCT01915160|Behavioral|eTF-CBT|Standard treatment with the edition of in-treatment/session iPad activities.
16132590|NCT01915160|Behavioral|TF-CBT|Treatment as usual.
16132591|NCT01915147|Drug|OXN PR followed by OxyPR tablets|
16132592|NCT01915147|Drug|OxyPR followed by OXN PR tablets|
16132593|NCT01915134|Drug|Recombinant Human Endostatin plus gemcitabine and cisplatin|target therapy plus chemotherapy:4-6 cycles of Recombinant Human Endostatin plus gemcitabine and cisplatin:Endostatin：7.5mg/m2/d,d1-14,concomitant with chemotherapy for 4-6 cycles.Gemcitabine and cisplatin:4-6 cycles of GP chemotherapy with gemcitabine 1000mg/m2,d1,8,cisplatin80mg/m2,d1.Chemotherapy will be given once every three weeks.
16132594|NCT01915134|Drug|Gemcitabine and cisplatin|only chemotherapy：Gemcitabine and cisplatin:4-6 cycles of GP chemotherapy with gemcitabine 1000mg/m2,d1,8,cisplatin80mg/m2,d1.Chemotherapy will be given once every three weeks.
16132595|NCT01915121|Behavioral|Education Intervention|1-hour educational and training sessions. In this session, participant will be provided with information about bladder cancer treatment options, and training tools directly related to Bladder Cancer. In 4 to 5 days following the session, participants will be asked to schedule the time to talk about experience and how the intervention affects their treatment decision making and to answer some questions about the educational and training session they attended. Participants will then be called after 1-month, 3-month, and 6-month after their bladder cancer treatment to follow up.
16132596|NCT01915121|Behavioral|Nutrition Intervention|1-hour educational and training sessions. In this session, participant will be provided with nutrition information directly related to Bladder Cancer recovery. In 4 to 5 days following the session, participants will be asked to schedule the time to talk about experience and how the intervention affects their treatment decision making and to answer some questions about the educational and training session they attended. Participants will then be called after 1-month, 3-month, and 6-month after their bladder cancer treatment to follow up.
16132597|NCT01915108|Drug|Remifentanil|All patients received a predetermined Ce of remifentanil by TCI according to their group assignments 10 minutes before the end of surgery (R0, remifentanil Ce of 0 ng/ml; R0.5, remifentanil Ce of 0.5 ng/ml; R1.0, remifentanil Ce of 1.0 ng/ml; R1.5, remifentanil Ce of 1.5 ng/ml).
16132598|NCT01915095|Device|rTMS|small magnetic pulses will be given to the brain in a non invasive manner.
16132599|NCT01915095|Device|Sham rTMS|sham or fake stimulation (TMS or rTMS) will be given to the brain in a non invasive manner
16132600|NCT01915095|Other|Training|at the direction of the researcher the participant will be instructed to do repetitive motor movements with their arm, hand or leg. this is called training
16132601|NCT01915095|Other|Motor Task|participants will be asked to perform specific motor tasks or movements with their fingers, hands, arms or legs.
16132602|NCT01915082|Drug|Azithromycin|"Zithromax® oral suspension 200 mg/ 5 mL (Pfizer, UK):
~Zithromax® 1000 mg syrup per os once at recipient intake for lung transplantation (day 0); followed by Zithromax® 250 mg syrup via (naso)gastric tube or per os every other day until one month after lung transplantation (days 1,3,5,7,9,11,13,15, 17,19,21,23,25,27,29 and 31)."
16132603|NCT01915082|Drug|Ora-Plus|"Ora-Plus® oral suspension (Paddock Laboratories, 3940 Quebec Avenue N, Minneapolis, MN 55427, USA; NDC-number: 0574-0303-16):
~Ora-Plus® 25mL syrup per os once at recipient intake for lung transplantation (day 0); followed by Ora-Plus® 6.25 mL syrup via (naso)gastric tube or per os every other day until one month after lung transplantation (days 1,3,5,7,9,11,13,15, 17,19,21,23,25,27,29 and 31)."
16132604|NCT01915069|Drug|Cilostazol|
16132605|NCT01915056|Other|GA-driven Intervention|For patients assigned to the treatment arm, individuals will be offered the option of completing the GA during a visit with their primary oncologist, or attending an additional visit at the multidisciplinary geriatric oncology clinic. The intervention consists of providing results of geriatric assessment in a summary to oncologists.
16132606|NCT01915043|Other|health education for lymphedema prevention|All subjects received a multimodal intervention consist in a multimodal program with an educational approach
16132607|NCT01915030|Other|High protein diet|controlled feeding trail. Both arms are caloric restricted
16132608|NCT01915030|Other|standard protein diet|
16132609|NCT01915017|Behavioral|Cognitive Behavior Therapy for Psychosis|The CBT manual to be used for the present study was based upon the work of Kingdon and Turkington (2005) and Granholm et al., (2005) a group-delivered CBT skills training). Available manuals were modified to improve ease of training and to better accommodate the delivery of the full CBT treatment in the home environment. Supervision will be provided throughout the study by D. Turkington and S. Tai world renowned experts in CBT for psychosis. Training will be held for 1-2 weeks annually and supervision will proceed weekly via SKYPE. All therapists will be certified prior to providing treatment for the trial. Sessions are conducted weekly by master's and doctoral level therapists.
16132610|NCT01915017|Behavioral|Cognitive Adaptation Training|CAT supports are established and maintained on weekly home visits by bachelor's and master's level staff. Regular supervision will be provided by the PI who developed CAT.
16132611|NCT01915017|Behavioral|Multi-modal Cognitive Therapy|A manual driven intervention combining CBT and CAT. Weekly sessions delivered in the home focus on altering cognitive biases using CBT and bypassing cognitive deficits using environmental supports
16132612|NCT01915017|Other|Treatment as Usual|Standard medication follow up and limited case management
16132613|NCT01915004|Other|Educational Intervention|Bladder Training Video
16132614|NCT01914991|Procedure|dynamic extension contracture orthotic|A dynamic orthosis was constructed in the experimental group using the same style of dynamic extension contracture orthotic. A mobilizing force of 250 - 300 gm/cm2 was set in each one. Patients were instructed to wear it for at least 6 hours per day and then removed it for ADL (Activity Daily Living). A static orthosis was constructed using orfitcast material to the maximum, pain-free length allowed by the tissues at night. Static and dynamic orthoses were checked once a week and adjusted as necessary.
16132738|NCT01913977|Device|Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):7L/min|Abylcap settings
16132615|NCT01914991|Procedure|conventional treatment Physical Therapy|Traditional treatment was applied to one control group. The treatment consisted of 10 minutes of local thermotherapy (paraffin), active exercises at the PIPJ and DIPJ (Distal interphalangeal joint), 3 sets of 15 repetitions of each exercise extending and flexing of the PIPJ with metacarpophalangeal joint from 0° to 90° respectively. Distal interphalangeal joint exercises were conducted with identical repetitions. The metacarpophalangeal joint and PIPJ exercises took place at 0 ° and involved stretching (5 sets of 3 reps, holding for 10 seconds) and Therapeutic U.S (0.8 w/cm2 / 7 minutes).
16132616|NCT01914978|Other|Food allergy handbook for parents|The food allergy handbook was designed to be a reliable resource to supplement physician management of food allergy, addressing key topics central to effective allergy management and maintenance of positive quality of life. The handbook includes evidence-based information about food allergies and their management, practical strategies for transferring allergy management skills into daily life, strategies for educating others about allergies, strategies for coping with common emotional challenges associated with food allergy, and strategies for teaching children and involving them in allergy management.
16132617|NCT01914978|Other|Food allergy treatment as usual|
16132618|NCT01914965|Drug|Bupropion|Crossover design: Oral administration of 150 mg bupropion once daily for 2 weeks, followed by 300 mg bupropion once daily for subsequent 8 weeks, tapering: 150 mg bupropion once daily for 7 days
16132619|NCT01914965|Drug|Placebo|Crossover design: Oral administration of placebo once daily for 2 weeks, followed by placebo once daily for subsequent 8 weeks, tapering: placebo once daily for 7 days
16132620|NCT01914952|Dietary Supplement|CaHMB capsule|1.0 gram of CaHMB powder in a gelatin capsule
16132621|NCT01914952|Dietary Supplement|HMB free acid gelcap|0.8 g HMB free acid is a soft gel capsule
16132622|NCT01914952|Dietary Supplement|HMB free acid mixed in water|0.8 g HMB free acid in water
16132623|NCT01914952|Dietary Supplement|CaHMB in water|1.0 g CaHMB powder mixed in water
16132624|NCT01914952|Dietary Supplement|HMB free acid|0.8 g HMB free acid
16132625|NCT01914939|Drug|Oxytocin|
16132626|NCT01914939|Behavioral|Social Skills focused CBT|
16132627|NCT01914939|Behavioral|Stress management/relaxation training|
16132628|NCT01914939|Drug|placebo drug|
16132629|NCT01914926|Drug|Metoprolol|
16132630|NCT01914926|Drug|Diltiazem|
16132631|NCT01914913|Biological|BMMNCs|Intervention therapy , Total 3 doses ,in 30 days ,in 7days interval ,transfer of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)
16132632|NCT01914900|Drug|docetaxel, cisplatin, 5 fluorouracil|
16132633|NCT01914887|Drug|Allogeneic adipose tissue-derived mesenchymal stem cells|The cells will be given in different sites within the affected colonic submucosa at a total dose of 60 million cells with the use of a colonoscope.
16132634|NCT01914874|Behavioral|Mindfulness Meditation|
16132635|NCT01914848|Other|Advance Care Planning ACP|Patient of the intervention group get a decision aid video and library and up to 3 consultations with qualified Advance Care Planning Facilitators.
16132636|NCT01914848|Other|Control Group|A routine care discharge planning with the social service
16132637|NCT01914835|Behavioral|Motivational Chess|"The Motivational Chess (MC) combines Motivational Interviewing with chess game. Volunteers are submitted to 10 sessions of 90 minutes, over three weeks (total 15 hours: 10 hours of chess practice and 5 hours of motivational interviewing).
~The Active Control (AC) group consists of ten structured activities using cardboard, paper, crayons, among others. Volunteers are submitted to 10 sessions of 90 minutes, over three weeks (total 15 hours: 10 hours of recreational activities and 5 hours of information about basic cognitive functions)."
16132638|NCT01914822|Drug|methylphenidate hydrochloride|
16132639|NCT01914822|Drug|Sugar pill (placebo)|
16132640|NCT01914809|Other|samples blood|
16132641|NCT01914809|Other|biopsy placentaire|
16132642|NCT01914796|Drug|PF-06412562|Single doses, given by oral solution, starting at 0.5 mg up to a possible maximum of 150 mg. The subject will have been fasted for 10 hours prior to the single dose. Two doses, 120 mg and 150 mg, will be split into 3 doses such that the total dose is given over 8 hours (i.e. t = 0, 4, and 8 hours). For each dosing period, 2 subjects will be given a placebo as a comparator. One dose will be given in the fed state.
16132643|NCT01914796|Drug|PF-06412562|It is believed that for increasing doses of this compound the eye blink rate (EBR) will also increase. This arm will use EBR measurement technology to verify this hypothesis. In each dosing period, 4 subjects will be given a placebo as a comparator.
16132644|NCT01914783|Other|ultrafine particles|exposure to ultrafine particles
16132645|NCT01914783|Other|ultrafine particles and ozone|exposure to ultrafine particles and ozone
16132646|NCT01914783|Other|clean air|Exposure to clean air.
16132647|NCT01914770|Drug|Belimumab 1 mg/kg|Subjects received belimumab 1 mg/kg in addition to their ongoing stable systemic lupus erythematosus (SLE) treatment regimen. Belimumab was administered intravenously at 0, 2, 4 weeks and every 4 weeks thereafter. The ongoing SLE treatment regimen was to have been stable for at least 30 days prior to Day 0, which consisted of any of the following (alone or in combination): prednisone or equivalent (from 0 to 40 mg/day when used in combination with other SLE treatment or from 7.5 to 40 mg/day alone), anti-malarials, non-steroidal anti inflammatory drugs (NSAIDs), or any immunosuppressive therapy (ie, methotrexate, azathioprine, leflunomide, or mycophenolate calcineurin inhibitors, sirolimus, oral cyclophosphamide, 6-mercaptopurine, or thalidomide).
16132648|NCT01914770|Drug|Belimumab 10 mg/kg|Subjects received belimumab 10 mg/kg in addition to their ongoing stable SLE treatment regimen. Belimumab was administered intravenously at 0, 2, 4 weeks and every 4 weeks thereafter. The ongoing SLE treatment regimen was to have been stable for at least 30 days prior to Day 0, which consisted of any of the following (alone or in combination): prednisone or equivalent (from 0 to 40 mg/day when used in combination with other SLE treatment or from 7.5 to 40 mg/day alone), anti-malarials, NSAIDs, or any immunosuppressive therapy (ie, methotrexate, azathioprine, leflunomide, or mycophenolate calcineurin inhibitors, sirolimus, oral cyclophosphamide, 6-mercaptopurine, or thalidomide).
16132734|NCT01913990|Drug|Dexamethasone, Ondansetron, Aprepitant|Arm B participants will be given doses of anti-emetics based on the emesis risk calculation. Doses will vary depending on the which level they fall into level 0, level 1, 2 or 3 based on the participant's diary.
16132735|NCT01913990|Other|Arm A: Standard Anti-emetic regimen|Treating physician's discretion for type of anti-emetic to be prescribed.
16132649|NCT01914770|Drug|Placebo|Subjects received placebo in addition to their ongoing stable SLE treatment regimen. Placebo was administered intravenously at 0, 2, 4 weeks and every 4 weeks thereafter. The ongoing SLE treatment regimen was to have been stable for at least 30 days prior to Day 0, which consisted of any of the following (alone or in combination): prednisone or equivalent (from 0 to 40 mg/day when used in combination with other SLE treatment or from 7.5 to 40 mg/day alone), anti-malarials, NSAIDs, or any immunosuppressive therapy (ie, methotrexate, azathioprine, leflunomide, or mycophenolate calcineurin inhibitors, sirolimus, oral cyclophosphamide, 6-mercaptopurine, or thalidomide).
16132650|NCT01914757|Biological|Benralizumab|Benralizumab subcutaneously on study week 0 until study week 52 inclusive.
16132651|NCT01914757|Biological|Placebo|Placebo subcutaneously on study week 0 until study week 52 inclusive.
16132652|NCT01914744|Drug|Entecavir|entecavir 0.5 mg/day PO
16132653|NCT01914744|Drug|Lamivudine|lamivudine 100 mg/day PO
16132654|NCT01914731|Drug|Fecal Microbiota Transplant|"Reconstitution of normal flora by a stool transplant from a healthy individual to a C. difficile - infected recipient via frozen capsule"
16132655|NCT01914718|Drug|DA-EPOCH-R|rituximab 375mg/m2 IV day 0, etoposide 50mg/m2/d CIV days 1-4, doxorubicin 10mg/m2/d CIV days 1-4, vincristine 0.4mg/m2/d CIV days 1-4, cyclophosphamide 750mg/m2 IV day 5, prednisone 50mg PO days 1-5 twice per day
16132656|NCT01914705|Procedure|Landmark Procedure|Using Landmarks to guide SCVC placement
16132657|NCT01914705|Procedure|Ultrasound Guided Procedure|Using ultrasound to guide SCVC placement
16132658|NCT01914692|Drug|Somatostatin|Somatostatin is a kind of traditional medicines ,which is for the treatment of intestinal fistula，upper gastrointestinal hemorrhage.
16132659|NCT01914679|Device|RINCE|The intervention is repeat applications of RINCE therapy. The sham is created by not delivering the therapy stimulation signal.
16132660|NCT01914666|Drug|Duloxetine|Administered orally
16132661|NCT01914653|Device|Silk surgical mesh|A CE Marked, 510(k) cleared, knitted, multi-filament, bioengineered, silk mesh indicated for use as a transitory scaffold for soft tissue support and repair
16132662|NCT01914627|Drug|Dimethicone|The treatment will be carried out once daily (in the evening) onto all scaling areas of the scalp over a period of 2 weeks, with the last application of investigational products being applied one day prior to the final visit.
16132663|NCT01914627|Drug|Salicylic Acid|The treatment will be carried out once daily (in the evening) onto all scaling areas of the scalp over a period of 2 weeks, with the last application of investigational products being applied one day prior to the final visit.
16132664|NCT01914601|Device|Macintosh-King Vision|laryngoscopy will be performed with the Macintosh followed by the King Vision laryngoscope
16132665|NCT01914601|Device|King Vision-Macintosh|laryngoscopy will be performed with the King Vision followed by the Macintosh laryngoscope.
16132666|NCT01914588|Procedure|Telemonitoring|Use of wearable sensors able to record peripheral oxygen saturation, heart rate, systolic, diastolic and average blood pressure, body weight, average physical activity, with automatic transmission to the monitoring central.
16132667|NCT01914588|Other|Standard care|"Detailed instruction about medical therapy and lifestyle counseling
~Telephonic support by a geriatrician, available from Monday to Friday, two hours/day
~Follow-up visits"
16132668|NCT01914575|Device|Mapping with the Acutus Medical System followed by Ablation|
16132669|NCT01914562|Drug|OCA 10 mg|OCA 10 mg tablet oral
16132670|NCT01914562|Drug|OCA 25 mg|OCA 25 mg tablet oral
16132671|NCT01914523|Device|Macintosh|Laryngeal exposure and tracheal intubation using that device
16132672|NCT01914523|Device|King Vision|Laryngeal exposure and tracheal intubation using that device
16132673|NCT01914523|Device|Glidescope|Laryngeal exposure and tracheal intubation using that device
16132674|NCT01914523|Device|AirTraq|Laryngeal exposure and tracheal intubation using that device
16132675|NCT01914510|Drug|ENMD-2076|
16132676|NCT01914497|Device|Acutus Medical System Mapping|
16132677|NCT01914484|Drug|Nilotinib|Nilotinib dose will remain fixed at 400mg bid throughout the cycles. BCR-ABL kinase inhibitor
16132678|NCT01914484|Drug|Ruxolitinib|"In the phase I part of the study, dose escalation will follow a 3+3 study design at either of 3 fixed dose levels (10 mg bid, 15 mg bid or 20 mg bid).
~No intra-patient dose-escalation will occur. JAK inhibitor"
16132679|NCT01914471|Behavioral|Students for Nutrition and eXercise|These schools received the entirety of Students for Nutrition and eXercise, a middle-school-based obesity-prevention intervention combining school-wide environmental changes, multimedia, encouragement to eat healthy school cafeteria foods, and peer-led education and marketing
16132680|NCT01914458|Procedure|Low-dose computed tomography (LDCT)|Low-dose computed tomography scan
16132681|NCT01914445|Drug|Indigo Carmine|Oral administration of Indigo Carmine prior to colonoscopy
16132682|NCT01914432|Drug|YH16410|
16132683|NCT01914432|Drug|Rosuvastatin|
16132684|NCT01914432|Drug|Telmisartan|
16132685|NCT01914432|Drug|YH16410 placebo|
16132686|NCT01914432|Drug|Rosuvastatin placebo|
16132687|NCT01914432|Drug|Telmisartan placebo|
16132688|NCT01914419|Drug|Oxytocin|
16132689|NCT01914406|Other|high intense interval training|Each AIT session consisted a 10 minute warm-up period followed by 16 minutes of interval training consisting of intervals of 4-3-2 and 1 minutes duration at 85-95% of their peak capacity separated by 2-4 min active rest.
16132690|NCT01914406|Other|continuous moderate training|Continued exercise 45 min.
16132691|NCT01914393|Drug|Lurasidone 20, 40, 60, 80 mg, flexibly dosed|Lurasidone 20, 40, 60, 80 mg once daily, flexibly dosed
16132692|NCT01914380|Drug|Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)|Patients will be followed-up for 24 months
16132693|NCT01914367|Biological|cervarix|3 doses will be given, one on Day 0, one on Day 30 and one on Day 180 ± 7 days, intramuscular in the deltoid muscle of the non-dominant arm
16132694|NCT01914367|Biological|Gardasil|3 doses will be given, one on Day 0, one on Day 60 ± 2 days and one on Day 180 ± 7 days, intramuscular in the deltoid muscle of the non-dominant arm
16132695|NCT01914341|Other|Music|Live music played on the pentatonically tuned children's harp
16132736|NCT01913977|Device|Abylcap® System: blood flow (QB): 200mL/min; gas flow (QG):7L/min|Abylcap settings
16132737|NCT01913977|Device|Abylcap® System: blood flow (QB): 300mL/min; gas flow (QG):7L/min|Abylcap settings
16132696|NCT01914315|Behavioral|Cardiac Rehabilitation|Patients will participate in a 6-month cardiac rehabilitation program, consisting of structured, 60-minutes, bi-weekly exercise training sessions according to a predefined protocol. Institutional activity will be complemented by 120 minutes weekly home exercise prescribed by specialist in cardiac rehabilitation. Exercise prescription will be based on a symptom limited exercise test when clinically feasible and according with the patients' functional capacity, medical history and physiological values obtained prior to exercise. Target heart rate will be set initial as 50-60% of heart rate reserve and gradually increased up to 80% of HRR. Aerobic exercise will be complemented by resistance training of low intensity.
16132697|NCT01914315|Other|Internal Medicine|Following discharge, patients will return to the IM outpatient clinics at 2-4 weeks, 3, and 6 months for consultation. These scheduled consultations will comprise of history taking, recording of any new events, physical examination and recommendations as clinically indicated. Target values for blood pressure and glucose control will be in accordance with current guidelines and special emphasis given to management of fluid retention.
16132698|NCT01914302|Device|Delica Lancing Device|Characterize Blood Volume and Pain under normal use circumstances
16132699|NCT01914302|Device|Flash Lancing Device|Characterize Blood Volume and Pain under normal use circumstances
16132700|NCT01914302|Device|Easy Touch Lancing Device|Characterize Blood Volume and Pain under normal use circumstances
16132701|NCT01914302|Device|Glucoject Lancing Device|Characterize Blood Volume and Pain under normal use circumstances
16132702|NCT01914302|Device|Microlet Lancing Device|Characterize Blood Volume and Pain under normal use circumstances
16132703|NCT01914302|Device|Multiclix Lancing Device|Characterize Blood Volume and Pain under normal use circumstances
16132704|NCT01914302|Device|Fastclix Lancing Device|Characterize Blood Volume and Pain under normal use circumstances
16132705|NCT01914302|Device|Reli-On Lancing Device|Characterize Blood Volume and Pain under normal use circumstances
16132706|NCT01914289|Procedure|Resection|
16132707|NCT01914289|Radiation|Radiotherapy|
16132708|NCT01914263|Biological|cytokine induced killer cell|The eligible patients are infused with a single dose of 8x10^9 cord blood-derived cytokine indued killer cells.
16132709|NCT01914250|Drug|Analgesic effect of topical tetracaine 2 %|The patient will be held by the parents and comforted after local anesthesia is applied by a research investigator. Then, he will be placed on procedure's board repositioned for clipping, restrained by the parent/nurse (holding both head and arms, keeping with conventional practice). Exactly 5 minutes after the topical anesthetic was applied, the pediatric dentist will press down the chin gently straddling the frenulum while and holding it in place with visualization of tongue base. Then the frenulum will be snipped along the underside of the tongue to its base. The area will be checked to ensure complete release. Bleeding will be controlled by pressuring with a 2x2 gauze pad under the tongue. A study investigator will film the procedure using GO PRO Video Camera mounted on the forehead of the pediatric dentist
16132710|NCT01914237|Device|Castor Stent Graft|Endovascular Repair of Aortic Dissection
16132711|NCT01914224|Behavioral|dietary education of low sodium and high potassium consumption|
16132712|NCT01914224|Behavioral|dietary education of low sodium consumption only|
16132713|NCT01914211|Drug|Tranexamic Acid|100mg/kg prior to incision, 100mg/kg on CPB and 100mg/kg after reversal of heparin with protamine.
16132714|NCT01914211|Procedure|Acute Normovolemic Hemodilution|Draw 20 mL/kg (up to 5Kg) of blood from patient and replace with washed PRBCs at 10-20mL/kg. (If > 5Kg draw 20% of circulating blood volume without PRBC replacement)
16132715|NCT01914198|Other|Sleep apnea symptom survey|Parents or caregivers will complete a questionnaire regarding possible sleep apnea symptoms.
16132716|NCT01914185|Other|Comprehensive School Health (CSH)|APPLE Schools uses a CSH approach to health promotion which addresses health through four inter-related pillars 1) positive social and physical environments 2) teaching and learning 3) healthy school policy 4) partnerships and services. A key component of the APPLE Schools intervention was the placement of a full-time School Health Facilitator in each school. Their role was to facilitate the development and implementation of the project, to ensure that it met the schools' unique needs for health promotion, and that it aligned with the core principles of CSH.
16132717|NCT01914172|Other|online questionairres|see group descriptions
16132718|NCT01914159|Drug|Ranibizumab (Lucentis, Novartis Pharma GmbH, Germany)|Monthly intravitreal injections
16132719|NCT01914146|Other|Insulin|Initiation of insulin administration will be determined as part of standard of care by the subjects diabetologist in the VGH Diabetes Centre and not as part of participation in this study.
16132720|NCT01914146|Other|No Insulin|Study session will occur prior to initiation of insulin therapy.
16132721|NCT01914133|Drug|Acarbose|Acarbose 50 mg given during Meal Test and Acarbose 25 mg taken with first bite of the next 3 meals.
16132722|NCT01914133|Drug|Placebo|Placebo given prior to meal the standardized meal
16132723|NCT01914107|Procedure|real-time monitoring and instruction of cancer pain|as description in arm
16132724|NCT01914107|Procedure|standard cancer pain care|as description in arm
16132725|NCT01914094|Behavioral|Prehab|
16132726|NCT01914081|Other|Resveratrol|Patients will receive one uncoated immediate-release caplets containing 500 mg resveratrol, twice daily for the 12 month intervention period
16132727|NCT01914081|Other|Placebo|Patients will receive one uncoated caplet containing placebo, twice daily for the 12 month intervention period
16132728|NCT01914068|Other|Supervised exercise in hospital|
16132729|NCT01914055|Device|angio-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)|angio-guided thrombus aspiration with monorail thrombus aspiration catheter (Eliminate, Terumo, Tokyo, Japan)
16132730|NCT01914055|Device|OCT-guided thrombus aspiration (Eliminate catheter, Terumo, Tokyo, Japan)|FD-OCT-guided thrombus aspiration with monorail thrombus aspiration catheter (Eliminate, Terumo, Tokyo, Japan); OCT images will be acquired at the site of culprit coronary artery with a commercially available system (Lunawave System; Fastview catheter/Terumo, Tokio, Japan OR C7 System; LightLab Imaging Inc; C7 Dragonfly catheter/St Jude Medical, Westford, MA)
16132731|NCT01914042|Drug|Morphine|
16132732|NCT01914042|Drug|Milnacipran|
16132733|NCT01914016|Other|prolonged walk|Participants will be asked to walk for a duration of between 2 -6 minutes until they rate their perceived exertion as 'Hard' (RPE 16 on Borg Scale)
16132739|NCT01913977|Device|Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):1.5L/min|Abylcap settings
16132740|NCT01913977|Device|Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):3L/min|Abylcap settings
16132741|NCT01913977|Device|Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):6L/min|Abylcap settings
16132742|NCT01913977|Device|Abylcap® System: blood flow (QB): 400mL/min; gas flow (QG):8L/min|Abylcap settings
16132743|NCT01913964|Drug|Acetylcarnitine|
16132744|NCT01913964|Drug|Placebo|(sugar pill)
16132745|NCT01913951|Drug|vosaroxin|Given IV over 10 minutes on Day 1 and 4
16132746|NCT01913951|Drug|Azacitidine|Given SC or IV over 15 minutes on days 1-7
16132747|NCT01913925|Other|Tyrosine-Containing Food Bar|
16132748|NCT01913925|Other|Placebo Bar|
16132749|NCT01913912|Drug|LDX.|"In this study 3 different doses of LDX will be used:
~30 mg capsules: 30 mg LDX, equivalent to 8.9 mg of dexamphetamine
~50 mg capsules: 50 mg LDX, equivalent to 14.8 mg of dexamphetamine
~70 mg capsules: 70 mg LDX, equivalent to 20.8 mg of dexamphetamine"
16132750|NCT01913912|Drug|sugar pill|Children will take once only a placebo capsule during the DBPC phase (phase 4) the morning of the testing. For blinding purpose we will blindfold the children when taking placebo.
16132751|NCT01913912|Device|computer task (Go/No-Go task)|
16132752|NCT01913912|Device|EEG|event-related potentials (ERP) and heart rate measurements
16132753|NCT01913912|Device|pupil size measurements (by using eye tracking)|
16132754|NCT01913899|Other|Occupational/ physical therapy|
16132755|NCT01913899|Other|Mirror therapy|- Intervention group: treatment sessions of 60 minutes with mirror therapy over a period of 14 days starting directly post surgical (24-48 hours)
16132756|NCT01913886|Procedure|MSCs injection|MSCs cells will be injected in two aliquots of 10 ml by catheterism
16132757|NCT01913873|Other|serum concentration changes cardiac biomarkers|Serum concentration determination for cardiac biomarkers (CK-MB and Hs-cTn) preoperatively, at induction of anesthesia (after placement of the arterial line), upon arrival at the intensive care unit (ICU), as well as every 3 hours for 12 hours, then every 6 hours the following 12 hours and a last sample is taken 48 hours after surgery.
16132758|NCT01913860|Behavioral|Improving GP antibiotics prescribing behaviour|GPs will be asked to code their UTI patients within their patient management software. Anonomysed coded patients will be electronically extracted and this information will be provided as an audit and feedback report of the GPs antibiotic prescribing practices.
16132759|NCT01913847|Drug|Sildenafil|Oral sildenafil 20 mg TID for 12 weeks
16132760|NCT01913847|Drug|Placebo|Oral placebo TID for 12 weeks
16132761|NCT01913834|Drug|Forsteo|Subcutaneous administration 20 micrograms
16132762|NCT01913834|Drug|CP046 PTH CriticalSorb|Comparison of different doses of drug and nasal delivery devices
16132763|NCT01913808|Drug|Ferric carboxymaltose|Single intravenous dose ferric carboxymaltose
16132764|NCT01913808|Drug|ferrous glycine sulphate|Daily oral dose of 100 mg iron (ferrous glycine sulphate)
16132765|NCT01913795|Other|integrated pest management|integrated pest management and environmental strategy
16132766|NCT01913795|Other|air purifier|air purifiers
16132767|NCT01913795|Other|Sham air purifier|sham air purifiers
16132768|NCT01913769|Radiation|Thallium-201 Myocardial Perfusion Study|One-day Tl-201 stress/rest MPI protocol with pharmacological stress, as daily practice will be applied. CZT camera with multipinhole collimator and stationary detectors scan heart simultaneously. A 10% symmetrical energy window at 140 keV was used. Electrocardiogram-gated scans will be applied. Perfusion images were reconstructed in standard axis and polar maps of the left ventricle were obtained. Scans from CZT was analyzed in consensus by two experienced readers blinded to any information on patient identification. The software package Myovation for Alcyone, QGS and QPS were used for quantitative analysis of MPI polar maps. Automated analysis to determine ejection fraction.
16132769|NCT01913756|Dietary Supplement|Gamalost (Norwegian traditional cheese)|
16132770|NCT01913756|Dietary Supplement|Gouda-type cheese|
16132771|NCT01913730|Drug|Bortezomib|
16132772|NCT01913730|Drug|Dexamethasone|
16132773|NCT01913717|Radiation|External beam radiotherapy|The patients will be treated with extreme hypofractionated radiotherapy with the dose delivery system that will result most fit at the in-silica study. Simultaneous Integrated Boost (SIB) technique will be applied to deliver a total dose of 36.25 Gy in 5 fractions (over 10 days) to the whole prostate (7.25 Gy/fraction) and 37.5 Gy to the dominant intraprostatic lesion DIL (7.5 Gy/fraction), profiting of the high sensibility of prostate cancer to high dose/fraction. Several strategies will be applied in order to reduce the dose to the surrounding organs at risk.
16132774|NCT01913704|Device|NatroxTM Device|"The NatroxTM device is a system to deliver oxygen from an oxygen generator topically to the wound via a proprietary device.
~The NatroxTM ODS oxygen delivery device will be applied to the wound and attached to the oxygen generator and switched on at the time of first dressing application at enrolment. Secondary dressings will then be applied. The oxygen delivery device will be removed and reapplied at each dressing change for a treatment period of 6 weeks."
16132775|NCT01913691|Drug|Ipilimumab|Ipilimumab is a recombinant, human monoclonal antibody that binds to CTLA-4. It is commercially available under the brand name Yervoy . The use of ipilimumab for MCC is investigational: a study-specific supply of medication will be provided by Bristol-Myers Squibb.
16132776|NCT01913678|Other|Inulin|The participants will be given all dietary items in their diet. In the inulin arm, approximately 15 grams of inulin will be included in the diet.
16132777|NCT01913678|Other|Complete diet|The participants will be given all dietary items in their diet with no additional products.
16132778|NCT01913678|Other|Whole milk|The participants will be given all dietary items in their diet. In the whole milk arm, approximately 1 liter of whole milk will be included in the diet.
16132779|NCT01913665|Other|B.lactis|
16132780|NCT01913665|Other|Inulin|
16132781|NCT01913665|Other|B.Lactis +Inulin|
16132782|NCT01913665|Other|Placebo|
16132783|NCT01913652|Drug|Cabazitaxel|
16132784|NCT01913639|Drug|Regorafenib|
16132785|NCT01913639|Drug|5-Fluorouracil|
16132786|NCT01913639|Drug|Leucovorin|
16132787|NCT01913639|Drug|Oxaliplatin|
16132875|NCT01912885|Device|TENS 2-1|Electrical stimulation using Transcutaneous Electrical Nerve Stimulation on two legs once a week.
16132788|NCT01913626|Behavioral|cognitive group therapy|the cognitive group therapy is composed of eight meetings including information about memory processes, learning and practicing tools and strategies to improve cognition and memory.
16132789|NCT01913613|Device|IASD|IASD device implantation
16132790|NCT01913600|Device|Resolute Integrity Stent|Drug eluting stent (DES)
16132791|NCT01913587|Device|Acupuncture|Acupuncture points are ST36, GB34 (bilateral), BL60 (bilateral), BL40 (bilateral), and 2 Back-su points (bilateral). Back-su points are selected as close as possible to pain region. Electroacupuncture will be performed at only 2 Back-su points (bilateral).
16132792|NCT01913587|Procedure|Nerve block|Epidural nerve block uses the mixture (10ml) of dexamethasone (10 mg) and bupivacaine (10 mg) dissolved in saline solution. Medial branch block uses mepivacaine (10 mg).
16132793|NCT01913574|Device|Acupuncture|Acupuncture is applied three times a week for 20 minutes for 2 weeks (total 6 sessions). 9 Acupuncture points, CV12, CV13, P6, SP4, ST36(bilateral),LI4 (bilateral), LR3 (bilateral), ST34 (bilateral), and GB21(bilateral) are used, and CV12, CV13, ST36, and LR3 are electro-stimulated.
16132794|NCT01913574|Procedure|Neurolytic celiac plexus block (NCPB)|An anaesthetic test is performed injecting 2ml mepivacaine. After assessing the efficacy and safety of this test, 10 ml of absolute alcohol is injected via each needle.
16132795|NCT01913561|Device|Master Caution Garment|"Master Caution Garment is embedded with 10/13 textile dry electrodes that enable 12/15-lead ECG.
~The electrodes are dry, textile ECG electrodes."
16132796|NCT01913561|Device|ECG gel electrodes|Standard gel electrodes that are been in use in hospital for ECG monitoring.
16132797|NCT01913535|Drug|CERC-501|"Low dose of CERC-501 will be 10 mg/day during the first phase (3 days) and during the second phase (3 days).
~High Dose of CERC-501 will be 20 mg/day during the first phase (3 days) and during the second phase (3 days).
~For patients randomly assigned to the placebo/low-dose drug sequence, the patient will receive placebo for 3 days and then 10 mg/day CERC-501 for the following 3 days.
~For patients randomly assigned to the placebo/high-dose drug sequence, the patient will receive placebo for 3 days and then 20 mg/day CERC-501 for the following 3 days."
16132798|NCT01913535|Drug|Placebo|"For patients randomly assigned to the placebo/ placebo sequence, study medication will be placebo during the first phase (3 days) and during the second phase (3 days).
~For patients randomly assigned to the placebo/low-dose drug sequence, the patient will receive placebo for 3 days and then 10 mg/day CERC-501 for the following 3 days.
~For patients randomly assigned to the placebo/high-dose drug sequence, the patient will receive placebo for 3 days and then 20 mg/day CERC-501 for the following 3 days."
16132799|NCT01913522|Procedure|Pulmonary Vein Isolation|
16132800|NCT01913509|Device|Combined Therapy of FES and BAT|FES treatment is applied to stimulate the supraspinatus muscle and the posterior deltoid muscle of the affected shoulder. Then patients receive bilateral arm training focused on reaching, shoulder abduction, and shoulder horizontal abduction.
16132801|NCT01913509|Device|Conventional Rehabilitation|Stroke patients in CR group receive the protocol which includes (1) TENS; (2) BAT. The activities are adapted based on the level of motor impairment, and functional needs of individual patients.
16132802|NCT01913496|Other|ebalance|using the ebalance application for 14 weeks
16132803|NCT01913483|Drug|Bivalirudin|Bivalirudin is an anticoagulant that binds directly to thrombin in a bivalent and reversible fashion.
16132804|NCT01913483|Drug|Unfractionated Heparin|Unfractionated heparin is an anticoagulant.
16132805|NCT01913470|Drug|Losartan|Oral tablet to be taken once daily at 0.4mg/kg/day (max 25mg) for one week and then increased to 0.8mg/kg/day (max 50mg) for 7 additional weeks.
16132806|NCT01913457|Radiation|Ultrasound Doppler|Doppler Ultrasound recording on external right chest wall
16132807|NCT01913444|Drug|Recombinant Antithrombin|
16132808|NCT01913431|Drug|Baracle Tab.®|
16132809|NCT01913431|Drug|Baraclude Tab.®|
16132810|NCT01913418|Drug|Suan-Zao-Ren Tang|SZRT is composed of five herb ingredients as follows: Semen Zizyphi Spinosae (Suanzaoren), Sclerotium Poriae Cocos (Fuling), Radix Ligustici Chuanxiong (Chuanxiong), Rhizoma Anemarrhena (Zhimu), and Radix Glycyrrhizae (Gancao).The SZRT granules were packed in aluminum foil packages and administered orally at a dose of 4 g, three times per day for four weeks.
16132811|NCT01913418|Drug|Suan-Zao-Ren Tang placebo|The Suan-Zao-Ren Tang placebo granules are prepared with 4 g starch inside the same colored and sized foil packages.
16132812|NCT01913405|Biological|PEGylated Recombinant factor VIII (rFVIII)|Lyophilized powder and solvent for solution for injection
16132813|NCT01913392|Procedure|laparoscopic sleeve gastrectomy|
16132814|NCT01913379|Drug|MDV3100|Oral
16132815|NCT01913379|Drug|Gemfibrozil|Oral
16132816|NCT01913379|Drug|Itraconazole|Oral
16132817|NCT01913366|Behavioral|CM-PST|
16132818|NCT01913366|Behavioral|SG-PST|
16132819|NCT01913353|Biological|MVA BN®|0.5 ml MVA BN® with a nominal titer of 1x10E8 TCID50, administered as a subcutaneous injection
16132820|NCT01913353|Biological|ACAM2000®|0.0025 ml ACAM2000®, consisting of 2.5-12.5x10E5 plaque forming units of live vaccinia virus (VACV). Picked up with a bifurcated needle and administered by the percutaneous route (scarification) using 15 jabs of that bifurcated needle.
16132821|NCT01913340|Drug|Erythropoietin|1000 U/kg/dose IV x 5 doses
16132822|NCT01913340|Drug|Normal saline|placebo: NS IV x 5 doses
16132823|NCT01913327|Drug|Aripiprazole|
16132824|NCT01913327|Drug|Risperidone|Week One, Risperidone 1 mg po qd; Week Two, 2 mg po qd; Week Three, 4 mg po qd; Week Four, 6 mg po qd; Week Five (and thereafter), 8 mg po qd.
16132825|NCT01913327|Drug|Modafinil|Single-dose 200 mg once orally, versus placebo single-dose, added-on to antipsychotic medication.
16132826|NCT01913314|Drug|[^14C]-LY2835219|Administered as oral solution
16132827|NCT01913301|Drug|Alagebrium|
16132828|NCT01913288|Other|Biological Maternal Sounds|
16132829|NCT01913275|Procedure|Endoscopic stenting|Endoscopic stenting to decrease preopertaive jaundice
16132830|NCT01913275|Procedure|cholecystojejunostomy|surgical procedure to decrease preoperative jaundice
16132831|NCT01913262|Behavioral|Standard Behavioral treatment|Standard behavioral treatment (e.g. problem solving therapy, cognitive behavioral treatment)
16132832|NCT01913249|Procedure|LIFT|Ligation of intersphincteric fistula tract
16132876|NCT01912885|Device|TENS 2-2|Electrical stimulation using Transcutaneous Electrical Nerve Stimulation on two legs twice a week.
16132833|NCT01913236|Other|Implementation intervention|Investigators will provide a comprehensive package of interventions to assist health care professionals to adhere to the recommendations. The package will include support for developing a collaborative care plan in the municipality, resources for general practitioners and other health care professionals, resources for patients, their relatives and volunteers,outreach visits to general practitioners' practices and their educational groups, educational resources and web-based resources.
16132834|NCT01913223|Device|Nestis® jet injector system with a bi-functional catheter|
16132835|NCT01913210|Dietary Supplement|Ginseng|
16132836|NCT01913197|Other|An MRI-based technique to identify prostate cancer|
16132837|NCT01913184|Device|AKITA|
16132838|NCT01913171|Other|Exercise|
16132839|NCT01913158|Drug|Anucort-HC, 25 Mg Rectal Suppository|Hydrocortisone acetate suppositories
16132840|NCT01913158|Drug|Placebo suppository|Hydrogenated palm kernel oil suppositories
16132841|NCT01913145|Device|A1c, Self-collection, Blood sample|This is a study to evaluate the safety and effectiveness of Micro-Serum/Micro-Blood (finger Stick) Specimen Collection as compared to samples obtained by standard venipuncture (blood taken from the arm vein).
16132842|NCT01913132|Device|Negative pressure wound therapy with PICO (Smith & Nephew)|Negative wound pressure therapy
16132843|NCT01913119|Drug|Romidepsin|"Day 1, 8, and 15 of a 28-day cycle Romidepsin Treatment is repeated until documented disease progression or unacceptable toxicity.
~Dose and administration: 4-hour infusion of 14 mg/m2"
16132844|NCT01913106|Drug|HSV-tk +Valacyclovir in Combination with Brachytherapy|"The investigators insert a gene from a herpes simplex virus (HSV), which is a small piece of the basic structure of the virus, into the prostate gland tumor cells. The gene is called the thymidine kinase (tk) gene, which the cell uses to make a protein that can change valacyclovir, The way the tk gene will be transported into the tumor cells is by using a vector or vehicle to carry the tk gene into the cells. In this case the vector is a virus - an adenovirus. Scientists at the Department of Cell and Gene Therapy at The Methodist Hospital removed a portion of the adenovirus' genetic material that allows it to replicate so that it cannot cause infections. In place of the removed genetic material the scientists inserted the tk gene. Now the vector can carry the tk gene into tumor cells. When the vector/gene combination gets into tumor cells, it inserts itself into the cells' command center (nucleus) and tells the tumor cells to begin making thymidine kinase protein."
16132845|NCT01913080|Other|Health Log|"The Health Log consists of a permanent booklet and a refillable health log version that is filled out before each doctor's appointment. The permanent booklet has areas to record:
~Personal information and emergency contact(s)
~Physician names and contact information
~Insurance information
~Medications, vitamins and supplements
~Surgeries
~Health history The booklet also includes suggested questions you may want to ask your Rheumatologist about medications, lifestyle, or future/status.
~The refillable health log includes questions about pain, fatigue,overall status from the Multi-Dimensional Health Assessment Questionnaire (MDHAQ), and a modified Arthritic Pain and Joint Evaluation. It also has space to write questions for the doctor's visit and prescription refills needed."
16132846|NCT01913067|Drug|Cabazitaxel|Intravenous, 25 mg/m2 every 3 weeks
16132847|NCT01913067|Procedure|Contrast-enhanced whole brain MRI|Evaluation of the volumetric reduction in the size of the brain lesion(s).
16132848|NCT01913054|Drug|Fentanyl Injection|
16132849|NCT01913054|Drug|Etomidate Fat Emulsion Injection|
16132850|NCT01913054|Drug|Propofol Injection|
16132851|NCT01913028|Drug|MEDI9929|1st cohort : Dose 1 MEDI9929 or placebo 2nd cohort : Dose 2 MEDI9929 or placebo 3rd cohort : Dose 3 MEDI9929 or placebo
16132852|NCT01913028|Drug|Placebo|1st cohort : Dose 1 MEDI9929 or placebo 2nd cohort : Dose 2 MEDI9929 or placebo 3rd cohort : Dose 3 MEDI9929 or placebo
16132853|NCT01913015|Drug|abiraterone acetate|Given PO
16132854|NCT01913015|Dietary Supplement|dietary intervention|Receive low fat breakfast
16132855|NCT01913015|Dietary Supplement|dietary intervention|Receive high fat breakfast
16132856|NCT01913015|Other|pharmacological study|Correlative studies
16132857|NCT01913015|Other|questionnaire administration|Ancillary studies
16132858|NCT01913015|Other|laboratory biomarker analysis|Correlative studies
16132859|NCT01913002|Drug|LX4211 800 mg|
16132860|NCT01913002|Drug|LX4211 2000 mg|
16132861|NCT01913002|Drug|moxifloxacin 400 mg|
16132862|NCT01913002|Drug|LX4211 Placebo|
16132863|NCT01912989|Behavioral|Lifestyle counseling|Parents will participate in one telephone and one in person session of motivational interviewing prior to their participation in an 8 week parent-exclusive treatment focusing on parenting skills to improve their child's overweight.
16132864|NCT01912976|Drug|Er:YAG AFL-PDT|Er:YAG AFL was performed with 550-600 µm ablation depth, level 1 coagulation, 22% treatment density, and a single pulse. MAL cream was then applied under occlusion for 3 hrs and illuminated with a red light-emitting diode light at 37 J/cm2.
16132865|NCT01912976|Drug|MAL-PDT|a 1-mm thick layer of MAL (16% Metvix® cream, PhotoCure ASA, Oslo, Norway) was applied to the lesion and to 5 mm of surrounding healthy tissue. The area was covered with an occlusive dressing (Tegaderm, 3M, Saint Paul, MN, US) for 3 hours, after which the remaining cream was removed with saline gauze, and the red fluorescence of porphyrins was visualized with Wood's light. Each treatment area was then separately illuminated with red light-emitting diode (LED) lamps (Aktilite CL128; Galderma, Bruchsal, Germany) with peak emission at 632 nm and total light dose of 37 J cm-2. Areas scheduled to receive MAL-PDT received the second treatment 7 days later.
16132866|NCT01912963|Drug|Pertuzumab|
16132867|NCT01912963|Drug|Trastuzumab|
16132868|NCT01912963|Drug|eribulin|
16132869|NCT01912950|Device|Prowave LX IPL|
16132870|NCT01912937|Device|Angioplasty treatment with the CVI Drug-coated Balloon (DCB)|Angioplasty treatment with the CVI Paclitaxel-Coated, Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (CVI Paclitaxel-coated PTA Catheter)
16132871|NCT01912924|Device|Spinal cord stimulator (Boston Scientific)|spinal cord stimulator trial leads and hand held battery
16132872|NCT01912898|Device|No intervention,The group with vitamin D deficient will be treated by the Endocrinology Department by loading of vitamin D|
16132873|NCT01912885|Device|TENS 1-1|Electrical stimulation using Transcutaneous Electrical Nerve Stimulation on one leg once a week.
16132874|NCT01912885|Device|TENS 1-2|Electrical stimulation using Transcutaneous Electrical Nerve Stimulation on one leg twice a week.
16132877|NCT01912885|Device|TENS 0-1|Placebo: application os electrodes of Transcutaneous Electrical Nerve Stimulation on one leg once a week, without turning on the device.
16132878|NCT01912872|Drug|Omalizumab|Subcutaneous injection dose according to the IgE level and body weight.
16132879|NCT01912872|Drug|Budesonide|Budesonide (400 μg, 200 μg or 100 μg) tablets taken orally according to maximum daily dose.
16132880|NCT01912872|Drug|Formoterol|Formoterol 12ug tablets taken orally according to maximum daily dose.
16132881|NCT01912872|Drug|Budesonide|Budesonide (400 μg, 200 μg or 100 μg). Patients were instructed to take the inhaled budesonide doses every 12 hours following the specific administration instructions as per the manufactures' prescription information.
16132882|NCT01912872|Drug|Formoterol|Formoterol 12ug. Patients were instructed to take the inhaled formoterol doses every 12 hours following the specific administration instructions as per the manufactures' prescription information.
16132883|NCT01912859|Behavioral|Nutrition/physical activity intervention|Nutrition/physical activity intervention
16132884|NCT01912846|Behavioral|Interactive advance care planning|"The facilitator will begin each course of intervention by assessing the patient's and his/her family caregiver's readiness for engagement in ACP independently.
~Providing participant-centered care tailored to the specific needs of participants at each stage of readiness for engagement in ACP.
~Facilitating EOL care discussions throughout the dying process.
~A workbook and a video decision aid that briefly describes ACP to enhance participants' understanding of the essential elements in ACP."
16132885|NCT01912846|Behavioral|Attention usual care|a consistent master prepared nurse on the study team will provide the attention portion of the care. The initial meeting will occur before the patient discharges from hospital and the usual care nurse will give patients and family caregivers a workbook and a video with educational materials on how to manage common symptoms and a comprehensive list of resources available, including patient support organizations, support and financial assistance through the social work department..
16132886|NCT01912820|Dietary Supplement|green tea extract|Given PO
16132887|NCT01912820|Drug|quercetin|Given PO
16132888|NCT01912820|Other|placebo|Given PO
16132889|NCT01912820|Procedure|therapeutic conventional surgery|Undergo prostatectomy
16132890|NCT01912820|Other|laboratory biomarker analysis|Correlative studies
16132893|NCT01912794|Other|Sensory Intervention|"full sensory information, whose participants will practice balancing tasks without constraint sensory body;
~sensory constraint, whose participants will practice the same balance tasks with constraint body of visual and tactile information from the soles of the feet;
~control, whose participants will exercise activities involving cognitive and upper limbs."
16132894|NCT01912781|Device|FID 120947A contact lens disinfecting solution|Investigational 3% hydrogen peroxide solution intended for simultaneous cleaning, protein removal, disinfecting and storage of gas permeable contact lenses
16132895|NCT01912781|Device|Boston Simplus multi-action solution|Commercially available solution indicated for cleaning, removing protein, rinsing, disinfecting, conditioning, storing and cushioning of fluoro silicone acrylate and silicone acrylate rigid gas permeable contact lenses
16132896|NCT01912781|Device|Gas permeable contact lenses|Commercially available gas permeable contact lenses worn a minimum of 8 hours each day on a daily wear basis for the duration of the study (90 days).
16132897|NCT01912768|Device|FID 120947A contact lens disinfecting solution|Investigational 3% hydrogen peroxide solution intended for simultaneous cleaning, protein removal, disinfecting and storage of silicone hydrogel and soft contact lenses
16132898|NCT01912768|Device|renu fresh multi-purpose solution|Commercially available solution indicated for cleaning, removing protein deposits, rinsing, chemical disinfection, and storage of soft contact lenses
16132899|NCT01912768|Device|Soft contact lenses|Commercially available soft contact lenses worn a minimum of 8 hours each day on a daily wear basis for the duration of the study (90 days). A fresh pair will be dispensed on Day 0, Day 30, and Day 60.
16132900|NCT01912755|Drug|4% articaine with 1:100,000 epinephrine|If the primary anesthesia failed after ten minutes, an intraligamentary injection with 4% articaine with 1:100,000 epinephrine was performed and the procedure initiated. When access to the pulp chamber was available, intrapulpal anesthesia was given using 4% articaine with 1:100,000 epinephrine.
16132901|NCT01912755|Drug|2% lidocaine with 1:100,000 epinephrine|If the patient reported pain during treatment and access to the pulp chamber was not achieved, an IANB was performed with 2% lidocaine with 1:100,000 epinephrine.
16132902|NCT01912742|Behavioral|Very-low calorie diet (VLCD)|
16132903|NCT01912742|Behavioral|Low calorie diet (LCD)|
16132904|NCT01912729|Behavioral|Networked Peer Support with Peer Guide|Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a peer guide. The peer guide will be another high school student around the same age as participants.
16132905|NCT01912729|Behavioral|Networked Peer Support with Clinician Coach|Participants will have access to tools and lessons based on Cognitive Behavior Therapy through a web application that can be accessed on a smartphone or computer. Additionally, participants will have access to a private social network that connects them with other participants in the study. Participants will be supported by a clinical psychologist.
16132906|NCT01912716|Drug|high dose indomethacin|patients randomized to this intervention receive 200mg indomethacin
16132907|NCT01912716|Drug|standard dose indomethacin|patients randomized to this intervention receive 100mg indomethacin
16132908|NCT01912703|Other|Telephone interview|Subjects with incomplete data will be asked to complete a telephone interview
16132909|NCT01912690|Other|aerobic training|
16132910|NCT01912690|Other|aerobic and strength training|
16132911|NCT01912677|Drug|Nifedipine|
16132912|NCT01912677|Drug|Labetalol|
16132913|NCT01912677|Drug|Methyldopa|
16132958|NCT01912365|Procedure|Above Elbow Cast|
16132914|NCT01912651|Drug|cephalexin|This consists of a single dose of cefazolin or, in penicillin allergic patients, clindamycin administered at the time of anesthesia administration prior to the surgical incision. In the cohort randomized to receive post-operative antibiotics, the first choice intervention will be oral cephalexin (500 mg, three times daily or four times daily, for one week). In patients who are penicillin or cephalosporin allergic, we will prescribe clindamycin (300 mg, three times daily or four times daily, for one week). Patients will be followed up within 2 to 6 weeks of surgery and outcome measures assessed. Patients will, again, be seen at 6 months and 1 year post-operatively for outcome assessment.
16132915|NCT01912638|Device|Ologen Collagen Matrix|Ologen is a porous collagen-glycosaminoglycan matrix that decrease early postoperative scarring after penetrating anti-glaucomatous surgery by randomized collagen deposition and microcyst formation. Implantation of Ologen Collagen Matrix in trabeculectomy was performed.
16132916|NCT01912638|Drug|Provisc|Provisc is an cohesive viscoelastic.
16132917|NCT01912625|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo 3D-CRT
16132918|NCT01912625|Drug|Carboplatin|Given IV
16132919|NCT01912625|Radiation|Image Guided Radiation Therapy|Undergo IGRT
16132920|NCT01912625|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16132921|NCT01912625|Other|Laboratory Biomarker Analysis|Correlative studies
16132922|NCT01912625|Drug|Paclitaxel|Given IV
16132923|NCT01912625|Other|Pharmacological Study|Correlative studies
16132924|NCT01912625|Drug|Trametinib|Given PO
16132925|NCT01912612|Drug|Duloxetine|Subjects will receive 30 mg duloxetine orally for 7 days, then 60 mg duloxetine orally for 28 days, then 30 mg duloxetine orally x 14 days.
16132926|NCT01912599|Device|Sensimed Triggerfish|IOP will be measured with the Sensimed Triggerfish, which is a disposable silicone contact lens embedded with a wireless sensor. The sensing resistive gauge in the device is circular around the center of the lens and is placed over a circumference of 11.5 mm in diameter. This corresponds to the corneoscleral junction position, where maximum corneal deformation occurs as a result of changes in IOP. A soft patch containing the receiving antenna will be applied around the eye and transmits the information via wire to the recorder that the patient will wear around the waist. The patient can continue to wear spectacles during monitoring. The device records a total of 144 measurements over a 24-hour period.
16132927|NCT01912599|Device|Blood Pressure|Patients in both groups will be fitted with a blood pressure cuff that will measure pressures for 24 hours.
16132928|NCT01912586|Other|vacuum erection device|sildenafil: 25mg/day nightly for 3 months vacuum erection device: make erections for 10-15 minutes/day for 3 months
16132929|NCT01912573|Drug|Intranasal (IN) naloxone|
16132930|NCT01912573|Drug|Intravenous (IV) naloxone|
16132931|NCT01912573|Drug|Intramuscular (IM) naloxone|
16132932|NCT01912573|Drug|Intraosseus (IO) naloxone|
16132933|NCT01912560|Drug|CAT-2003|
16132934|NCT01912560|Drug|Placebo|
16132935|NCT01912560|Drug|Statin|All patients being treated with a stable dose of a statin prior to enrollment continue on their dosing regimen.
16132936|NCT01912547|Procedure|Blood draw for TEG analysis|Blood drawn for TEG analysis
16132937|NCT01912534|Drug|Valsartan|40, 80 and 160 mg tablets of Valsartan
16132938|NCT01912534|Drug|Placebo|During Active Run-In, all patients take Valsartan. During maintenance, all patients are randomized to valsartan or placebo
16132939|NCT01912521|Behavioral|Mfangano Health Net Microclinic Program|Educational program in which HIV positive individuals are invited to recruit their social networks to form 'microclinic' groups. These groups participate in a 6-month educational curriculum composed of information on HIV biology, interpersonal communication strategies and community mobilization. At the conclusion of the program, participants are encouraged to disclose their HIV status to members of their group through a facilitated disclosure process.
16132940|NCT01912495|Drug|Boceprevir|
16132941|NCT01912482|Other|Cardiorespiratory training|The cardiorespiratory training group will undergo 18 sessions, these also periodized in a maximum six weeks, respecting the minimum weekly frequency of 3 sessions.
16132942|NCT01912482|Other|ventilatory training|The ventilatory training group will undergo 18 sessions, periodized in a maximum six weeks, respecting the minimum weekly frequency of three sessions.
16132943|NCT01912469|Drug|Traumeel|oral, Day 1: one tablet every 15 minutes for two hours after the exercise test, 6 hours and 10 hours after the exercise test; Day 2 and 3: two tablets thrice daily; Day 4: two tablets in the morning
16132944|NCT01912469|Drug|Placebo|oral, Day 1: one tablet every 15 minutes for two hours after the exercise test, 6 hours and 10 hours after the exercise test; Day 2 and 3: two tablets thrice daily; Day 4: two tablets in the morning
16132945|NCT01912456|Biological|Low-volume C1-esterase inhibitor|
16132946|NCT01912456|Biological|Higher-volume C1-esterase inhibitor|
16132947|NCT01912456|Biological|Low-volume placebo|
16132948|NCT01912456|Biological|Higher-volume placebo|
16132949|NCT01912443|Drug|bevacizumab|5 mg/Kg, IV (in the vein) on day 1 and day 14 of each 28 day cycle. Number of Cycles: until progression.
16132950|NCT01912430|Behavioral|ICC (Integrated Care Coaching) Intervention Group|
16132951|NCT01912417|Other|Aerobic exercise with cycle ergometer during hemodialysis|Participants underwent hemodialysis trained on an cycle ergometer. The training is performed in the first 2 hours of hemodialysis, with a total exercise time of 60 minutes. Each exercise period of 20 minutes was separated by 10 minutes of rest. The patients are advised to work with a level of perceived exertion of 'somewhat strong' (13-14 of Borg scale). For safety, heart rate and blood pressure were monitored throughout the session. The training is terminated if the patients exceeded 80% of their maximum heart rate (MHR = 220 - age in years), blood pressure parameters are exceeded (above 200/110 or below 110/50mmHg) or the patient had chest pain, severe dyspnea, wheezing, leg cramps, confusion, visual symptoms, pallor or cyanosis.
16132952|NCT01912404|Drug|IDN-6556|25 mg BID for 28 days
16132953|NCT01912404|Drug|Placebo|Placebo controlled
16132954|NCT01912391|Drug|Selegiline|The Study Drug known as either selegiline 12 mg patch or matching placebo patch will be administered daily beginning at Visit 2 for the duration of 12 weeks.
16132955|NCT01912391|Drug|Placebo (for Selegiline)|Transdermal Placebo patch manufactured to mimic Transdermal Selegiline 12 mg. patch
16132956|NCT01912378|Drug|Oxytocin|
16132957|NCT01912378|Drug|Placebo nasal spray|
16132961|NCT01912339|Device|Rezum System|"The Rezūm System uses sterile water vapor (steam) to treat BPH by delivering targeted, controlled doses of stored thermal energy directly to the transition zone of the prostate gland.
~A narrow sheath, similar in shape and size to a cystoscope, is inserted transurethrally and positioned within the prostatic urethra between the bladder neck and the verumontanum.
~A thin needle is deployed through the urethra into the transition zone, and a very short (8-10 second) treatment of water vapor is delivered directly into the hyperplastic tissue and immediately disperses through the tissue interstices.
~Upon contact with the tissue, the vapor condenses, or phase shifts, into its liquid state, releasing the stored thermal energy contained within the vapor. This thermal energy is released directly against the walls of the tissue cells within the treatment zone, gently and immediately denaturing the cell membranes, thereby causing instantaneous cell death."
16132962|NCT01912339|Procedure|Rigid Cystoscopy|Endoscopy of the urinary bladder via the urethra.
16132963|NCT01912326|Device|Pacemaker Implantation|Implantation of a dual chamber pacemaker
16132964|NCT01912313|Procedure|Rectal biopsies from IBS patients or healthy subjects will be taken during proctoscopy|
16132965|NCT01912300|Behavioral|experimental condition: Passvice Video game; Avtive Video game; Exercise|
16132966|NCT01912287|Behavioral|Cognitive Behavioral Therapy|CBT focused on Generalized Anxiety Disorder (12 sessions)
16132967|NCT01912287|Behavioral|Stress Education|Active control group (12 sessions)
16132968|NCT01912287|Behavioral|Yoga|12 sessions, mindfulness components
16132969|NCT01912274|Drug|Pracinostat|Elderly newly diagnosed patients will all receive pracinostat
16132970|NCT01912274|Drug|Azacitidine|Elderly newly diagnosed patients will all receive azacitadine
16132971|NCT01912261|Drug|Placebo|one capsule orally daily times 84 days
16132972|NCT01912261|Drug|Polysaccharide iron complex|150 mg daily orally times 84 days
16132973|NCT01912248|Other|strength training|strength training, lower limb.
16132974|NCT01912235|Other|2-15N glutamine|Glutamine with N15 isotope tracer
16132975|NCT01912235|Other|15N2 arginine and 15N proline|Arginine and Proline isotope tracers
16132976|NCT01912235|Other|1-13C glutamine|Glutamine carbon isotope tracer
16132977|NCT01912222|Drug|IXAZOMIB|
16132978|NCT01912209|Behavioral|My Everyday Health|MyEveryday Health is a web-based nutritional and lifestyle management program. The program includes personalized diet and weight guidance, meal planners, shopping list generator, recipe finder, weight tracker and dining out and fast food guides. Based on specific algorithms, tips and suggestions on how to make changes in their diet and lifestyle will be give each time the subject logs in. The MyEverydayHealth website will also be available as an app for their smart phone to the participants. If they choose to use the app, daily reminders to log in and use their tools will be sent, along with motivating tool/tips/tricks to stay with the program.
16132979|NCT01912196|Drug|MSI-195|
16132980|NCT01912196|Drug|Placebo|
16132981|NCT01912183|Behavioral|Communication through PHR outside clinic|
16132982|NCT01912183|Behavioral|Monitoring device in PHR|
16132983|NCT01912183|Device|Physical activity and sleep monitor|
16132984|NCT01912183|Other|PHR|Access to their PHR
16132985|NCT01912170|Dietary Supplement|Fish oil|
16132986|NCT01912170|Dietary Supplement|Flaxseed oil|
16132987|NCT01912157|Behavioral|Expressive Writing|The intervention consists in 3 self-applied solitary written disclosure sessions (expressive writing)
16132988|NCT01912144|Other|Coffee|
16132989|NCT01912131|Behavioral|single pilot interview|Part 1 participants will be scheduled for their single pilot interview. There are no additional assessments.
16132990|NCT01912131|Behavioral|goals-of-care (GOC) video|Subjects will be shown the goals-of-care (GOC) video but not undergo a narrative interview process - they will be contacted as per re-assessment.
16132991|NCT01912131|Behavioral|goals-of-care (GOC) video and narrative question|subjects will watch the goals-of-care (GOC) video (described in detail in the next paragraph) and then be given the narrative question stem vetted/assessed in part 1 including any changes made to that stem in the process of Part 1 testing. Subjects in P-COCC arm will then be contacted for a telephone interview and audio-taping of their narrative. Interviews will be semi- structured and based off the narrative stem that subjects were previously given for review. Interviews will last approximately 30-45 minutes and will be conducted by staff from the MSKCC Department of Psychiatry & Behavioral Sciences,
16132992|NCT01912131|Behavioral|usual care|Subjects in the usual care arm will neither be given the narrative stem nor watch the video.
16132993|NCT01912131|Behavioral|Part 2|Will be a proof-of-concept, small scale, RCT to measure P-COCC acceptability and other quantitative and qualitative effects. Seventy five participants will be randomized to Usual Care, Video, or Video and Interview.
16132994|NCT01912118|Drug|Propofol|Propofol will be titrated via a target controlled infusion to reach a specific target BIS (as specified in treatment arm)
16132995|NCT01912118|Drug|Remifentanil|Remifentanil will be provided by a target controlled infusion to a specific effect site concentration (as specified in treatment arm)
16132996|NCT01912105|Device|Airway medix closed suction system|
16132997|NCT01912105|Device|standard closed suctioning systems|
16132998|NCT01912092|Device|Askina Calgitrol paste|
16132999|NCT01912066|Drug|Stillen|
16133000|NCT01912066|Drug|Cytotec (reference drug)|
16133001|NCT01912066|Drug|NSAID (Aceclofenac)|
16133002|NCT01912053|Radiation|Therasphere® in association with Gemcitabine and Cisplatin|Therasphere® is a radioelement
16133003|NCT01912040|Drug|Administration of 123Iodine MIBG|Patients will be administered the locally produced 123 Iodine MIBG
16133004|NCT01912027|Procedure|Open Latarjet technique|
16133005|NCT01912027|Procedure|Arthroscopic Latarjet techniques|
16133006|NCT01912014|Behavioral|Psychosocial support and counselling|
16133007|NCT01912001|Other|Telephone follow-up|
16133008|NCT01912001|Other|Sympton Assessment|
16133009|NCT01911975|Drug|Lacosamide|comparison between lacosamide 200mg twice daily and microcrystalline cellulose (placebo) 200mg twice daily.
16133010|NCT01911975|Drug|Placebo|comparison between microcrystalline cellulose (placebo) 200mg twice daily and lacosamide 200mg twice daily.
16133011|NCT01911962|Procedure|transvaginal laparoscopic surgery|
16133221|NCT01910480|Drug|Ketoconazole 400 mg (200 mg twice daily)|
16133012|NCT01911949|Drug|Single shot femoral nerve block|Nerve block in lingual crease using ultrasound guidance
16133013|NCT01911936|Drug|LM716|
16133014|NCT01911923|Procedure|No CPAP/PEEP and 100 % oxygen|This is the control group and 100 % oxygen will be used during induction of and emergence from anesthesia, no enhanced level of CPAP/PEEP is implemented. During controlled ventilation ventilation mode is volume controlled.
16133015|NCT01911923|Procedure|CPAP/PEEP and 30 % oxygen|During all phases of anesthesia CPAP/PEEP will be used together with 100 % oxygen during induction of as well during emergence from anesthesia until after extubation when 30 % oxygen will be used.
16133016|NCT01911910|Behavioral|Electronic coaching plus standard care|The HAPPY London web-based tool will provide the participant with an individualised score for their lifestyle and 10 year CV risk score, based mainly on the modified Framingham score, and provide tailored advice and education on the suboptimal factors. Ideal targets will be set and the information will be updated at 3 and 6 months allowing the participant to view their progress. Weekly emails with brief health and lifestyle advice will be sent to encourage healthier behaviour based on clinical studies or topical issues in the media. Links to social networks, such as Facebook posting and the ability to allow chosen family and friends to view their progress will aim to further encourage healthier behaviour.
16133017|NCT01911897|Device|MobiusHD|Implant that is placed in the carotid sinus to control hypertension.
16133018|NCT01911884|Behavioral|evaluate quality of life of surgical and non surgical vaginal aplasia|protocol designed to evaluate quality of life of surgical and non surgical vaginal aplasia
16133019|NCT01911871|Biological|Blood sample|a blood sample was taken on the day of inclusion
16133020|NCT01911858|Device|Askina Calgitrol Paste|
16133021|NCT01911845|Drug|ABT-450/r/ABT-267|Tablet; ABT-450 coformulated with ritonavir and ABT-267
16133022|NCT01911845|Drug|ABT-333|Tablet
16133023|NCT01911845|Drug|Ribavirin (RBV)|Tablet
16133024|NCT01911832|Procedure|esophagojejunostomy after total gastrectomy|
16133025|NCT01911832|Procedure|Roux-en-Y gastrojejunostomy after subtotal gastrectomy|
16133026|NCT01911832|Procedure|wide tube reconstruction after subtotal gastrectomy|
16133027|NCT01911832|Procedure|narrow tube reconstruction after subtotal gastrectomy|
16133028|NCT01911819|Procedure|Sinus augmentation|
16133029|NCT01911819|Drug|Equimatrix|Equimatrix cancellous particle size 0.2-1mm approximately 2g (4cc)
16133030|NCT01911819|Drug|OSSIF-i sem|OSSIF-i sem Mineralized Cancellous Bone Allograft SP 0.25-1.0mm approximately 2cc x 2
16133031|NCT01911819|Drug|Bio-oss|Bio-oss small granules cancellous 0.25-1mm, approximately 2g (4cc)
16133032|NCT01911806|Device|Back care pillow|back care pillow is specific size by age groups of standard deviation of the lumbar spinal curvature, in 20-29 years was 51.68 ± 6.94 degrees, in 30-39 years was 59.67 ± 7.02 degrees, in 40-49 years was 63.66 ± 7.62 degrees, in 50-59 years was 65.75 ± 10.85 degrees and in 60-69 years was 64.19 ± 9.69 degrees
16133033|NCT01911806|Procedure|standard physical therapy treatment|standard physical therapy treatment are ultrasound therapy and hot pack
16133034|NCT01911793|Device|Stoma Tube|Stoma tube will be inserted into stoma at the time of surgery for patients assigned to Stoma Tube group.
16133035|NCT01911780|Drug|placebo|placebo matching amlodipine capsule
16133036|NCT01911780|Drug|telmisartan + HCTZ|FDC tablet
16133037|NCT01911780|Drug|telmisartan + HCTZ|FDC tablet
16133038|NCT01911780|Drug|amlodipine|capsule
16133041|NCT01911754|Biological|H5N1 (Pre-)Pandemic Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated)|
16133042|NCT01911741|Drug|MDV3100|Oral
16133043|NCT01911728|Drug|MDV3100|Oral
16133044|NCT01911728|Drug|Pioglitazone|Oral
16133045|NCT01911728|Drug|Warfarin|Oral
16133046|NCT01911728|Drug|Omeprazole|Oral
16133047|NCT01911728|Drug|Midazolam|Oral
16133048|NCT01911715|Drug|MDV3100|Oral
16133049|NCT01911702|Other|Standard fluidic resuscitation.|"Goals:
~arterial pressure mean ≥ 65 mmHg or equal to the pre-operative
~diuretic rhythm ≥ 1 ml / Kg / h
~venous saturation in vena cava ≥ 70% or mixed venous saturation as Swan Ganz's catheter (SG) ≥ 65%
~BE> - 3
~Central Venous Pression (PVC) ≥ 8 mmHg; for patients undergoing mechanical ventilation, this limit may be raised to 12-15 mmHg."
16133050|NCT01911702|Other|Volemic small treatment|"Goals of the treatment:
~arterial pressure mean ≥ 60 mmHg or ≥ 10% less than the preoperative values
~diuretic rhythm ≥ 0.5 ml / kg / h
~venous saturation in vena cava ≥ 60% or mixed venous saturation ≥ 55% by SG
~BE> - 5
~PVC goal not necessary
~To achieve the therapeutic goals set out above will be executed a volemic fill up to values of PVC ≤ 5 mmHg or at maximum values of 2 mmHg more the incoming If after proper filling the targets aren't yet achieved, the patient will begin infusion of vasoactive drugs following the practice of department. If after 12 hours of admission the water balance will be > 10-15 ml / kg / h an infusion of furosemide should be initiated"
16133051|NCT01911676|Drug|PF-03463275|
16133052|NCT01911676|Drug|Placebo|
16133053|NCT01911663|Dietary Supplement|KRG|500 mg Korea red ginseng (KRG)
16133054|NCT01911663|Dietary Supplement|Placebo|500 mg placebo
16133055|NCT01911650|Other|Autologous Platelet Rich Plasma|This procedure will include a single collection of 35 mL of peripheral blood. A two-stage spinning protocol will be used: the 1st separates red blood cells from platelets, and the 2nd concentrates the platelets to yield approximately 4 mL of concentrated autologous platelet. This layer of platelet rich plasma will be placed in the syringe by the centrifuge machine.
16133056|NCT01911650|Other|Ultrasound Imaging|A conventional ultrasound in addition to AE and shear wave imaging (SWI) will be administered.
16133057|NCT01911650|Other|Quality of Life Questionnaires|This questionnaire is a self-report of pain and function associated with the Achilles tendon.
16133058|NCT01911637|Drug|VBY-036|Study drug VBY-036
16133059|NCT01911637|Drug|Placebo|Placebo
16133060|NCT01911624|Drug|direct thrombin inhibition|
16133061|NCT01911624|Drug|enoxaparin|
16133062|NCT01911611|Drug|RO6870868|Single ascending doses
16133063|NCT01911611|Drug|placebo|Single ascending doses
16133512|NCT01908582|Drug|Evacetrapib|Administered orally
16133064|NCT01911598|Drug|5-FU|5-FU will be administered as per schedule specified in the respective arm.
16133065|NCT01911598|Drug|Carboplatin|Carboplatin will be administered as per schedule specified in the respective arm.
16133066|NCT01911598|Drug|Cisplatin|Cisplatin will be administered as per schedule specified in the respective arm.
16133067|NCT01911598|Drug|MEHD7945A|MEHD7945A will be administered as per schedule specified in the respective arms.
16133068|NCT01911598|Drug|Paclitaxel|Paclitaxel will be administered as per schedule specified in the respective arm.
16133069|NCT01911585|Behavioral|Prolonged Exposure Therapy|Prolonged exposure therapy (PE), a specific exposure therapy program for PTSD is a highly effective treatment for PTSD. The key components of PE are imaginal exposure to the traumatic event and processing it (revisiting of the traumatic memory in imagination) followed by processing of the revisiting experience, and in vivo exposure to avoided trauma-related situations and objects.
16133070|NCT01911559|Device|standing-frame|
16133071|NCT01911546|Drug|everolimus + low-dose tacrolimus|Patients are supplied everolimus (Zortress) + prograf
16133072|NCT01911533|Procedure|extracorporeal removal of CO2 (ECCO2-R)|To promote a better gas-exchange, the patient with ARDS will be mechanically ventilated. This can be aggressive and harmful for the lungs. With the use of an extra-corporeal CO2-remover, CO2 can be removed so that the mechanical ventilation setting will be less aggressive and will decrease lesions in the lung. The veno-venous extracorporeal CO2-remover pumps blood from a vein via a catheter through an oxygenator (gas exchanger that adds oxygen to the blood and extracts carbon dioxide from the blood) and back into a vein.
16133073|NCT01911533|Procedure|No extracorporeal CO2-removal|Patients are their own control group.
16133074|NCT01911520|Drug|Sugammadex 2 mg/kg|Patients receive 2 mg/kg Sugammadex.
16133075|NCT01911520|Drug|Sugammadex. 4 mg/kg|Patients receive 4 mg/kg Sugammadex.
16133076|NCT01911520|Procedure|Neuromuscular monitoring.|Neuromuscular monitoring using a TOF watch SX (Organon).
16133077|NCT01911520|Procedure|Clinical evaluation of residual curarization .|Every 30 min, during the first 2 hours after the end of the surgery.
16133078|NCT01911507|Drug|INC280|Given PO
16133079|NCT01911507|Drug|erlotinib hydrochloride|Given PO
16133080|NCT01911494|Behavioral|Community Engagement|The primary objective of the community engagement activities in CLIP will be to create awareness and action around the prevention of maternal morbidity and mortality due to pre-eclampsia/eclampsia. Community engagement involves the collective action of individuals, families, religious leaders, policy makers,
16133081|NCT01911494|Device|PIERS on the Move mHealth decision aid|This mHealth application is to be used by community health workers in intervention clusters to guide collection of relevant clinical data during antenatal visits. This clinical data is used to generate a risk estimate for any women with hypertension based on the miniPIERS (Pre-eclampsia Integrated Estimate of Risk) clinical risk prediction model. This risk estimate in combination with other pre-defined treatment triggers (severe hypertension (>160mmHg systolic) or proteinuria (>3+ dipstick); absence of fetal movements for greater than 12 hours; signs of recent stroke of seizure) are collected in the app and based on this data recommendations for care of the woman are provided.
16133082|NCT01911494|Drug|Magnesium Sulfate|Women identified in intervention clusters by the community health worker during a study visit as being at high risk of- or having recently experienced- an eclamptic seizure will be given 10 g intramuscular magnesium sulfate prior to transfer to a nearby facility for further care.
16133083|NCT01911494|Drug|Methyldopa|Women identified in intervention clusters as having severe hypertension (systolic greater than 160 mmHg) by the community health worker during a study visit will be given 750 mg of oral methyldopa prior to transfer to a nearby facility for further care.
16133084|NCT01911481|Other|hydration|
16133085|NCT01911468|Drug|metformin|
16133086|NCT01911468|Drug|liraglutide|
16133087|NCT01911468|Drug|metformin and liraglutide|
16133088|NCT01911455|Drug|acamprosate|
16133089|NCT01911455|Drug|Placebo|
16133090|NCT01911442|Drug|Lurasidone 20 mg daily|Lurasidone 20 mg once daily
16133091|NCT01911442|Drug|Lurasidone|Lurasidone 60 mg once daily
16133092|NCT01911442|Drug|Placebo|Placebo
16133093|NCT01911429|Drug|Lurasidone 40 mg|Lurasidone 40 mg once daily
16133094|NCT01911429|Drug|Lurasidone 80 mg|Lurasidone 80 mg once daily
16133095|NCT01911429|Drug|Placebo 40 or 80 mg|Placebo 40 or 80 mg once daily
16133096|NCT01911416|Drug|LDE225|
16133097|NCT01911403|Procedure|Manual compression|Closure procedure by Manual compression
16133098|NCT01911403|Device|Angio-Seal|Closure procedure by angio-Seal
16133099|NCT01911390|Dietary Supplement|Bean powder|Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders.
16133100|NCT01911390|Dietary Supplement|Rice bran|USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties.
16133101|NCT01911390|Dietary Supplement|Control arm|No bean or rice bran additive in smoothie or muffin.
16133102|NCT01911390|Dietary Supplement|Bean powder and rice bran|Archer Daniels Midland (ADM) Edible Bean Specialties, Inc. will supply cooked navy bean powders. USDA (Beaumont, TX) provided rice bran for meals that was polished from U.S. rice mills using U.S. grown rice varieties.
16133103|NCT01911377|Drug|Botulinum Toxin Type A|
16133104|NCT01911377|Drug|Normal Saline for Injection|
16133108|NCT01911351|Drug|Nitrous Oxide|Patients randomized to the intervention arm will receive nitrous oxide plus standard management for their minor procedure.
16133109|NCT01911338|Device|Real Time Feedback|Before beginning practice, one of the teachers performed the manipulation and explained the graph parameters as real-time feedback to consider when interpreting the graph, leaving the graphic as the benchmark execution
16133110|NCT01911338|Device|Traditional Learning Method|Two expert teachers in manual therapy provided indications and corrections to the group with a teacher - student ratio of 1:8.
16133111|NCT01911325|Drug|Buparlisib|
16133112|NCT01911325|Drug|Buparlisib matching placebo|
16133113|NCT01911325|Drug|Docetaxel|
16133114|NCT01911312|Device|Thermal-aided muscle stimulation|Thermal-aided muscle stimulation is applied to subject quadriceps (one leg) with Niveus Medical Muscle Stimulation System 110
16133115|NCT01911312|Device|Body Temperature Stimulation|Body temperature stimulation is applied to subject quadriceps (one leg) with Niveus Medical Muscle Stimulation System 110
16133116|NCT01911299|Dietary Supplement|Choline|5.25 ml of liquid glycerophosphocholine (approximately 1240 mg GPC), equivalent to 625 mg of choline
16133117|NCT01911299|Dietary Supplement|placebo supplementation consisting of vegetable glycerin (50% by volume) and deionized water|
16133118|NCT01911286|Procedure|Apnea test - Standard|
16133119|NCT01911286|Procedure|Apnea test - CPAP|
16133120|NCT01911273|Drug|PF-03446962|PF 03446962 7 mg/kg, IV, every 2 weeks, until disease progression, patient refusal or unacceptable toxicity, whichever occurs first
16133121|NCT01911273|Other|Best Supportive Care|BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life
16133122|NCT01911273|Other|Placebo|Placebo will consist of Saline (0.9% w/v Sodium Chloride Injection, USP or NS)
16133123|NCT01911273|Other|Best Supportive Care|BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life.
16133124|NCT01911260|Dietary Supplement|Zinc amino acid chelate|During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup containing zinc amino acid chelate at 3%, i.e. the equivalent to 30mg of elemental zinc per ml, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student.
16133125|NCT01911260|Other|Placebo|During twelve weeks, children received weekly 1ml of lemon flavor caramel syrup, disposed into an individual amber glass, containing 20ml of syrup. The supplement administration was made individually with 1ml BD Plastipak disposable syringe, directly into the child's mouth, by the principal investigator. The chosen supplementation day was Tuesday. Therefore, the following weekdays were reserved to supplement any absent student.
16133126|NCT01911247|Drug|Metformin|Metformin 850 mg once daily
16133127|NCT01911234|Biological|TNF-Kinoid|IM administration
16133128|NCT01911234|Other|Placebo|IM administration
16133129|NCT01911221|Biological|rMenB+OMV NZ|Recombinant MenB with Outer Member Vesicle (OMV) from the New Zealand strain
16133130|NCT01911208|Behavioral|RECRUIT intervention|Sites randomized to RECRUIT are taught skills to develop a tailored recruitment intervention encompassing continuous quality improvement and patient navigation.
16133131|NCT01911208|Behavioral|Control|Non-intervention control.
16133132|NCT01911195|Drug|ISOFLURANE- Experimental Arm|The experimental group will be given the anesthetic isoflurane for three hours, and will undergo cognitive tests immediately following emergence from general anesthesia while connected to an EEG machine.
16133133|NCT01911195|Other|Control Group: Cognitive Testing|The control group will undergo cognitive testing while connected to an EEG machine following a comparable rest period, but will not receive general anesthesia.
16133134|NCT01911182|Other|Inhalation of low concentration of CO2|Inhalation of 1% CO2 through nasal prongs
16133135|NCT01911169|Drug|Cholecalciferol|5,000 International units versus 400 international units as an active comparator
16133136|NCT01911156|Drug|Continue NA treatment|Prescribed NA during the 72 week study period
16133137|NCT01911156|Drug|Discontinue NA Treatment|Discontinue NA Treatment
16133138|NCT01911104|Behavioral|Exercise|10 weeks of aerobic exercise
16133139|NCT01911091|Behavioral|Exercise|A 5-minute warm-up and a 5-minute cool-down prior to and following each exercise session, respectively. There will be alternating days of interval training and aerobic training. The interval training will be performed on an upright stationary bike, while the aerobic training will be performed on a treadmill. The interval training will consist of five-minute bouts of higher intensity alternated with 4 minutes of lower intensity for a total duration of 45 minutes. Intensity will increase each week. The aerobic training component will be fixed at a moderate intensity, but will increase in duration each week from 45 minutes to 75 minutes to 90 minutes during the third and final week.
16133140|NCT01911078|Procedure|Renal Denervation|Renal artery ablation with the EnligHTN™ Renal Denervation System.
16133141|NCT01911078|Device|EnligHTN™ Renal Denervation System.|
16133142|NCT01911065|Biological|Zostavax™|In the Vaccination arm, healthy individuals will be vaccinated with the licensed zoster vaccine, Zostavax.
16133143|NCT01911052|Other|Telephone based re-education|The investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus intervention such as telephone based re-education by one investigator on the day before colonoscopy.
16133144|NCT01911052|Other|Short message system based re-education|The investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus intervention such as short message system based re-education by one investigator on the day before colonoscopy.
16133145|NCT01911039|Biological|Regulatory T Cells|
16133146|NCT01911026|Other|Reinforcement Nurse Education|The investigational, or experimental arm, will receive standard written instructions on preparing for a colonoscopy plus instructions from reinforcement educated nurse
16133147|NCT01911013|Procedure|anterior cervical discectomy and fusion|anterior cervical discectomy and fusion with anterior plating or not
16133148|NCT01911013|Device|Cage and Plate|anterior cervical discectomy and fusion is performed using cervical cage and plate
16133149|NCT01911013|Device|Cage alone|anterior cervical discectomy and fusion is performed using cage alone with plate.
16133150|NCT01911000|Radiation|RT and hyperthermia after TACE|
16133151|NCT01910987|Drug|bortezomib (optimized retreatment)|Type= exact number, unit = mg/m2 body surface area, number = 1.3, form = powder for solution for injection, route = subcutaneous, injection on Days 1, 4, 8 and 11, every 21 days of cycle 1 and 2; injection on Days 1, 8, 15, 22, every 35 days for cycles 3 to 6; followed by injections on Days 1, 8, 15, 22 every 35 days (Group A1) or injections every other week (Group A2). Treatment will be stopped at confirmed disease progression
16133295|NCT01909895|Other|Depressed Mood Induction|The participant will be asked to undergo a validated depression/sadness induction task.
16133513|NCT01908582|Drug|Rifampin|Administered orally
16133152|NCT01910987|Drug|dexamethasone (optimized retreatment)|Type= exact number, unit = mg, number = 20, form = tablet, route = oral, intake on Days 1, 2, 4, 5, 8, 9, 11 and 12, every 21 days of cycle 1 and 2; intake on Days 1, 2, 8, 9, 15, 16, 22 and 23 every 35 days for cycles 3 to 6
16133153|NCT01910987|Drug|bortezomib (standard retreatment)|Type= exact number, unit = mg/m2 body surface area, number = 1.3, form = powder for solution for injection, route = subcutaneous, injection on Days 1,4,8,11, every 21 days for cycles 1 to 8 or until confirmed disease progression
16133154|NCT01910987|Drug|dexamethasone (standard retreatment)|Type = exact number, unit = mg, number = 20, form = tablet, route= oral, intake on Days 1, 2, 4, 5, 8, 9, 11, 12, every 21 days for cycles 1 to 8 or until confirmed disease progression
16133155|NCT01910974|Procedure|endoscopic sub-mucosal dissection|endoscopic sub mucosal dissection of oesophagus stomach intestine or rectum lesions
16133156|NCT01910961|Procedure|limb RIPC|LRIP consisted of three cycles of left upper limb ischemia induced by inflating a blood pressure cuff on the left upper arm to 200mmHg, with an intervening 5 minutes of reperfusion, during which time the cuff was deflated
16133157|NCT01910948|Drug|omega-3 polyunsaturated fatty acids|The included patients will be randomly divided into two groups A and B, two groups of patients 4 days before operation begin to give parenteral nutrition: A: the control group of normal intravenous nutrition. B: the trial group,add omega-3 polyunsaturated fatty acids 0.2 g/kg to parenteral nutrition, no use on the day of surgery, postoperative 2 days continue to add omega-3 polyunsaturated fatty acids 0.2 g/kg.
16133158|NCT01910935|Behavioral|Physical activity prescription to develop program in group.|Overall the intervention involves a medical reference in primary care (PHC) to hypertensive patients (during routine consultation) to assist the sports facilities of the same Institute, to develop a group program of physical activity which will last 24 weeks. Led by the trained staff in physical activity to patients with chronic diseases.
16133159|NCT01910909|Radiation|Stereotactic body radiotherapy|Respiration training will be done on the day that patient decided participate this study with wearing video goggle and headphone assisted respiration by visual and voice. Four dimensional CT simulation with wearing video goggle and headphone assisted respiration by visual and voice and real time position management system (PRM) signal will be adopted. Planning MRI with diffusion image also be acquired in same condition with CT simulation. SBRT will be delivered daily 20 Gy for 3 fractions.
16133160|NCT01910896|Device|Overnight Intensive Patch|Eligible subjects will have their two scars randomized for OIP application/no treatment. OIP for overnight application (at least 6 hours) for 12 to 24 weeks.
16133161|NCT01910883|Drug|Finafloxacin i.v. solution 200 mg|
16133162|NCT01910883|Drug|Finafloxacin i.v. solution 400 mg|
16133163|NCT01910883|Drug|Finafloxacin i.v. solution 600 mg|
16133164|NCT01910883|Drug|Finafloxacin i.v. solution 800 mg|
16133165|NCT01910883|Drug|Finafloxacin i.v. solution 1000 mg|
16133166|NCT01910883|Drug|Placebo i.v. solution|
16133167|NCT01910870|Drug|Cisplatin|25 mg/m² I.V. (day 1 to day 3) Total dose : 75 mg/m² every 3 weeks
16133168|NCT01910870|Drug|Metronomic Cyclophosphamide|150 mg per os from day 1 to day 14 (total dose = 2100 mg) every 3 weeks
16133169|NCT01910857|Behavioral|Lifestyle counseling|weight reduction, low salt, physical activity, stress reduction
16133170|NCT01910844|Drug|Cisplatin|25 mg/m² I.V. from day 1 to day 3 - total dose = 75 mg/m² every 3 weeks
16133171|NCT01910844|Drug|Cyclophosphamide|Metronomic cyclophosphamide per os 150 mg from day 1 to day 14 - total dose 2100 mg every 3 weeks
16133172|NCT01910831|Drug|DerMend Moisturizing Bruise Formula|DerMend Moisturizing Bruise Formula, a skin care cream containing a proprietary blend of retinol, ceramides, arnica oil, and alpha hydroxy acids and other ingredients.
16133173|NCT01910831|Drug|Non-active placebo control|Non-active placebo control
16133174|NCT01910818|Device|Fractional CO2 laser treatment|Patient will be treated with fractional laser treatment over the areas with fibrosis.
16133175|NCT01910818|Other|No treatment|Patient will also have an area that is not being treated with CO2 laser. This is the area not getting treatment.
16133176|NCT01910805|Behavioral|Lifestyle and Risk Assessment class|"Classes will be conducted by a CITI-certified Boston Public Health Commission nutritionist, who is a consultant on this project and has previously worked within the Boston African-American community to increase diabetes awareness and reduce diabetes risk. These classes will be held at a local community center to provide maximal accessibility to the women.
~The intervention group will attend classes mentioned at the aforementioned centers. Each class will take 2-hours and be conducted by a CITI-certified registered nutritionist with extensive knowledge of working in the African-American community. Both classes will include a cooking demonstration. In addition, the class will include a tour of a local supermarket to aid women in identifying healthy food choices."
16133177|NCT01910792|Device|Sperti Lamp|UV light exposure 3 times per week for 12 weeks
16133178|NCT01910779|Procedure|100 joule as first biphasic shock energy|
16133179|NCT01910779|Procedure|120 joule as first biphasic shock energy|
16133180|NCT01910766|Drug|Coenzyme Q10|no more details
16133181|NCT01910766|Drug|clomiphene citrate|
16133182|NCT01910753|Procedure|APA|A 3-month program for physical activity and diet education will be followed. An exercise specialist will supervise patients twice per week, during the first six weeks. They will also follow nutrition counselling and therapeutic education by a dietician once per week. During the last six weeks, they will just follow a guide for safe and appropriate exercise regimen. The dietician will call patient weekly during this final period.
16133183|NCT01910740|Other|Enhanced Physical Activity|Individually tailored programs focused on increasing the amount of time participants spend performing mobility activities, particularly standing and walking in the late afternoons and evenings and on weekends. These participants will be provided with one or two extra sessions on weekdays and two extra sessions on weekend days for the duration of their rehabilitation stay.
16133184|NCT01910740|Other|Usual Care|Therapy provided by a multidisciplinary team which includes physiotherapy and occupational therapy on weekdays with other allied health input (eg speech pathology, social work) as indicated. Medical and nursing care is also provided seven days a week.
16133185|NCT01910740|Other|Social Interaction|To control for the extra hours of physical activity that the experimental group receives, participants in the control group shall have additional activities such as card and board games, conversation or reading as well as upper limb exercises and other physical activities that have minimal impact on ambulant mobility.
16133186|NCT01910727|Behavioral|Together on Diabetes-Hopkins|The Johns Hopkins Center for American Indian Health, with support from Bristol-Myers Squibb Foundation, Inc. is adapting a Family Health Coach model for diabetes prevention with four southwestern tribal communities. Specifically, Johns Hopkins Center for American Indian Health has designed a paraprofessional delivered pilot intervention aimed at improving the prevention and management of type 2 diabetes among American Indian youth. For Youth Participants, the pilot intervention consists of 12 sessions delivered during a 6-month intervention phase, plus 6 check-ins delivered during a 6-month follow-up phase. For Support Persons, the pilot intervention consists of 4 family skill building sessions delivered during the first 4 months of the Youth Participant's intervention phase.
16133187|NCT01910714|Behavioral|Focus On Youth|Focus on Youth is a community-based, eight session group intervention that provides youth with the skills and knowledge they need to protect themselves from HIV and other STDs. Focus on Youth uses fun, interactive activities such as games, role plays and discussions to convey prevention knowledge and skills pertaining to Protection Motivation Theoretical concepts. The intervention consists of 8 group sessions delivered daily over 8 days by two Apache facilitators to same-sex peer groups of 8-12 Apache youth. Each lesson lasts approximately 60-90 minutes. The goal of the sessions will be to teach youth about sexual and reproductive health with a specific focus on safe sex practices and sexual decision making.
16133188|NCT01910714|Behavioral|Health Education Control Condition|The health education control condition consists of team-building activities and viewing of educational videos on nutrition and fitness, environmental protection and nature. The control condition program will be delivered according to the same structure as the Focus on Youth intervention; daily for 60-90 minutes over the course of 8 days. Due to local staffing availability and the pilot nature of this research, youth in the control condition will not receive the control program in small-group peer format. Rather, youth will receive the control condition program in groups of approximately 30-50.
16133189|NCT01910701|Behavioral|Family Spirit|The Family Spirit intervention consists of 52 sessions (30-60 minutes in duration) delivered during a 39-month intervention phase and designed to positively impact a number of maternal and child behavioral and health outcomes.
16133190|NCT01910688|Device|RFA treatment|If eligible for enrollment, a focal ablation device is selected as an intervention(size according to physician preference) and mounted on the end of the endoscope and introduced via the mouth into the esophagus and gastric pouch. The gastric pouch is treated from the top of the gastric folds to and just through the stomal anastomosis.
16133191|NCT01910675|Drug|PCC|15 IU/kg Octaplex and 2 g Riastab. Additional fibrinogen if needed.
16133192|NCT01910675|Drug|FFP|4 units Octaplas. Additional fibrinogen if needed.
16133193|NCT01910662|Other|KLH 0.1 mg|KLH will be administered as single ID injection of 0.1 mg as 0.1mL of KLH (1 mg/mL)
16133194|NCT01910662|Other|KLH 5 mg|KLH will be administered as single SC injection of 5 mg
16133195|NCT01910662|Other|PBS (0.1 mL)|PBS will be administered in Part A on Day 1 as 3 ID injections and in Part C: Cohort 1 on Day 1 and Day 2 as a single ID injection
16133196|NCT01910662|Other|Tuberculin PPD|Tuberculin PPD will be administered in Part B Cohort 2 on Day 1 as single ID injection of 2TU (0.04 microg/mL) in each forearm. In Part C Cohort 2 PPD will be administered on Day 1 as a single ID injection of 2TU. On day 3, if the induration is 6 mm or more; 2 ID injections of 2 TU will be administered on Day 29 in Part B Cohort 2 and 1injection of 2TU on Day 29 in Part C Cohort 2. On day 3, if the induration is less than 6 mm, subject will be re-challenged with 10 TU (0.04 microg/mL) PPD followed by 2 ID injections of 10 TU on Day 29 in Part B Cohort 2 or 1 ID injection of 10TU on Day 29 in Part C Cohort 2.
16133197|NCT01910649|Drug|Drisapersen|Subcutaneous and Intravenous
16133198|NCT01910636|Drug|Sofosbuvir|Sofosbuvir 400 mg tablet administered orally once daily
16133199|NCT01910636|Drug|RBV|Ribavirin (RBV) tablets were administered orally in a divided daily dose according to package insert weight-based dosing according to the approved Copegus labeling in Japan (< 60 kg = 600 mg , > 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)
16133200|NCT01910623|Other|Health Related Quality of Life (HRQOL) measures|
16133201|NCT01910610|Biological|FOLFIRI-cetuximab|
16133202|NCT01910610|Biological|mFOLFOX6-bevacizumab|
16133203|NCT01910610|Biological|OPTIMOX-bevacizumab|
16133204|NCT01910610|Biological|irinotecan-based chemo + bevacizumab|
16133205|NCT01910610|Biological|Anti-EGFR agent (cetuximab +/- irinotecan or panitumumab)|
16133206|NCT01910610|Biological|XELOX + bevacizumab|
16133207|NCT01910597|Drug|SBG|
16133208|NCT01910584|Procedure|Novasure endometrial ablation|Novasure endometrial ablation is the second generation endometrial ablation treatment aimed to cure the dysfunctional uterine bleeding(DUB),including menorrhagia.
16133209|NCT01910571|Drug|P7435|
16133210|NCT01910571|Other|Placebo|
16133211|NCT01910558|Dietary Supplement|Alpha-cyclodextrin and digestible starch|Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 3 gram alpha-cyclodextrin and 3 gram of starch
16133212|NCT01910558|Dietary Supplement|Alpha-cyclodextrin|Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 6 grams alpha-cyclodextrin
16133213|NCT01910558|Dietary Supplement|Digestible starch|Weight maintaining diet (40% fat, 30% protein, and 30% carbohydrate) supplemented with 6 grams digestible starch
16133214|NCT01910545|Drug|OTS167IV|
16133215|NCT01910532|Drug|Clevidipine|Clevidipine for the treatment of acute hypertension defined SBP > 160 mmHg in patients who require an Intracranial Pressure Monitoring Device
16133216|NCT01910519|Biological|H5N1 vaccine plus AS03 adjuvant|"Administered vaccine: [GlaxoSmithKline] Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.
~Participants receive 2 intramuscular doses of Influenza A (H5N1) Virus with AS03 adjuvant, administered 21 (+/- 3) days apart."
16133217|NCT01910519|Biological|H5N1 vaccine without adjuvant|"Administered vaccine: [GlaxoSmithKline] Influenza A (H5N1) Virus Monovalent Vaccine without AS03 adjuvant.
~Participants receive 2 intramuscular doses of Influenza A (H5N1) Virus without adjuvant, administered 21 (+/- 3) days apart."
16133218|NCT01910506|Drug|RDEA3170 10 mg|
16133219|NCT01910493|Behavioral|SMS reminders|Intervention participants only will be sent text messages to their phones. The content of text messages will have a maximum of 160 characters and not mention HIV and will state the dates for the forthcoming consultations, visits to the pharmacy, lab results, time to take medication and reminders for patients who miss appointments.
16133220|NCT01910480|Drug|NBI-98854 50 mg capsule once daily|
16133222|NCT01910467|Device|NIRS visible and predefined interventions|NIRS measurements are visible and the patients will be treated according to predefined clinical interventions: If cTOI/pTOI ratio increases >5% within a six-hours-period echocardiography will be performed and based on results of echocardiography and blood pressure a volume bolus or, if ventilated, modification of ventilation or treatment of patent ductus arteriosus will be considered.
16133223|NCT01910467|Device|NIRS not visible and treatment as usual|NIRS not visible and the patients will be treated according to routine
16133224|NCT01910454|Behavioral|Cognitive-Oriented Strategy Augmented Rehabilitation (COSTAR)|The protocol for COSTAR is based on the Cognitive-Orientation to daily Occupational Performance Intervention (CO-OP) approach which includes the following components: (1) Guided discovery - a process created by CO-OP to make certain that participants discover the strategies that will solve their own performance problems ; (2) Cognitive strategy use - participants are taught a global problem-solving strategy and are enabled to discover additional domain specific strategies that will support their skill acquisition and performance competence; and (3) Dynamic performance analysis - an observation-based process of identifying performance problems or performance breakdown. These three components from CO-OP are overlaid on the TST intervention protocol described above to address the overall hypothesis of this study: that an evidence-based stroke rehabilitation treatment protocol (task-specific training) can be enhanced when augmented with the catalyst of cognitive-oriented strategy use.
16133225|NCT01910454|Behavioral|Task Specific Training (TST)|The protocol for task-specific training is based on criteria established by Winstein and Wolf (2008) who define task-specific training (TST) as a top-down approach to rehabilitation that is based on recent integrated models of motor control, motor learning, and behavioral neuroscience and that addresses skill acquisition of performance of meaningful and relevant tasks (Winstein and Wolf, 2008). Winstein and Wolf use current theory to identify three key ingredients for a task-specific training (pg 269): (1) Challenging enough to require new learning, and engagement with attention to solve the motor problem; (2) Progressive and optimally adapted such that over practice, the task-demand is optimally adapted to the patient's capability and the environmental context. The task should not be too simple or too repetitive nor too difficult; and (3) Interesting enough to invoke active participation through engagement in meaningful activity.
16133226|NCT01910441|Drug|Vildagliptin|Vildagliptin 50 mg twice daily
16133227|NCT01910441|Drug|Glimepiride|Glimepiride 1-6 mg once daily
16133228|NCT01910441|Drug|Metformin|Metformin (1000-1500 mg daily)
16133229|NCT01910428|Drug|L-asparaginase encapsulated in RBC|"50 IU/kg IV
~100 IU/kg IV
~150 IU/kg IV
~200 IU/kg IV"
16133230|NCT01910415|Drug|Lumacaftor|
16133231|NCT01910415|Drug|Lumacaftor Placebo|
16133232|NCT01910415|Drug|Ivacaftor|
16133233|NCT01910415|Drug|Ivacaftor Placebo|
16133234|NCT01910415|Drug|moxifloxacin hydrochloride|
16133235|NCT01910402|Drug|Dolutegravir/abacavir/lamivudine FDC|Dolutegravir/abacavir/lamivudine FDC tablets, 50 mg/600 mg/300 mg
16133236|NCT01910402|Drug|Atazanavir|Atazanavir capsule 300 mg
16133237|NCT01910402|Drug|Ritonavir|Ritonavir tablet 100 mg
16133238|NCT01910402|Drug|Tenofovir/emtricitabine FDC|Tenofovir/emtricitabine FDC tablet 300 mg/200 mg of FTC
16133239|NCT01910389|Drug|Tadalafil|
16133240|NCT01910389|Drug|Placebo for tadalafil|
16133241|NCT01910363|Drug|A2NTX|Intramuscular injection of the botulinum toxin preparation in 300 units (mouse LD50) into tibialis posterior and medial gastrocnemius muscles on the affected side.
16133242|NCT01910363|Drug|BOTOX|Intramuscular injection of the botulinum toxin preparation in 300 units (mouse LD50) into tibialis posterior and medial gastrocnemius muscles on the affected side.
16133243|NCT01910350|Behavioral|Kin KeeperSM Cancer Prevention Intervention|
16133244|NCT01910350|Other|Standard of care|
16133245|NCT01910337|Device|Use the Polar Cardiac rate meter|
16133246|NCT01910324|Behavioral|Multidimensional Family Therapy Cross-Systems|Standard initial/engagement work in the home and detention, plus a state-of-the-art HIV education prevention module as well as standard MDFT which assesses and intervenes in five domains: 1) Interventions with the adolescent, 2) interventions with the parent, 3) interventions to improve the parent-adolescent relationship, 4) interventions with other family members, and 5) interventions with external systems.
16133247|NCT01910324|Behavioral|Enhanced Services as Usual|Standard drug treatment services in detention and state-of-the-art HIV education prevention intervention, as well as outpatient drug treatment provided by community drug treatment providers
16133248|NCT01910311|Drug|Baricitinib|Administered orally
16133249|NCT01910311|Drug|Rifampicin|Administered orally
16133250|NCT01910298|Procedure|Breast Reconstruction, Direct to Implant (DTI) with Strattice™|
16133251|NCT01910298|Procedure|Two Stage Breast Reconstruction|
16133252|NCT01910285|Drug|Remifentanyl - sufentanil placebo|Induction of general anesthesia with 3 mg/kg of propofol combined with 3 µg/kg of remifentanil and 10 ml of isotonic sodium chloride for the double blind. The trachea is then intubated after waiting the time of action of each product.
16133253|NCT01910285|Drug|Sufentanil - remifentanyl placebo|Induction of general anesthesia with 3 mg/kg of propofol combined with 0.3 mg/kg of sufentanil and 25 ml of isotonic sodium chloride for the double blind. The trachea is then intubated after waiting the time of action of each product.
16133254|NCT01910272|Device|All subjects are wearing the non-lead attenuation cap (BLOXR)|The cap is worn by all subjects with dosimeters secured both inside and outside the cap.
16133255|NCT01910259|Drug|Amiloride|Comparison with placebo
16133256|NCT01910259|Drug|Riluzole|Comparison with placebo
16133257|NCT01910259|Drug|Fluoxetine|Comparison with placebo
16133258|NCT01910259|Drug|Placebo|Placebo comparator
16133259|NCT01910246|Drug|Metformin|
16133260|NCT01910220|Drug|REGN1033 (SAR391786)|
16133261|NCT01910220|Other|placebo|
16133262|NCT01910194|Drug|Luyxumia versus Lantus|
16133263|NCT01910181|Drug|Vemurafenib|Participants will receive vemurafenib at a dose of 960 mg twice daily orally.
16133264|NCT01910155|Drug|Ciprofloxacin/Dexamethasone|
16133265|NCT01910155|Drug|Ciprodex (R)|
16133266|NCT01910155|Drug|Placebo|
16133296|NCT01909895|Other|Anxiety Induction|The participant will be asked to undergo a validated anxiety induction task.
16133539|NCT01908348|Dietary Supplement|Erythritol|
16133267|NCT01910142|Dietary Supplement|vitamin K|A calcium product will be given either with or without vitamin K. Each intervention will last for 5 weeks, each followed by a 5 week wash-out. The first intervention will start about 4 months after inclusion and the single 41Ca bolus.
16133268|NCT01910142|Dietary Supplement|calcium|
16133269|NCT01910129|Device|gammaCore|vagal verve stimulation 3 times a day 8 hours apart
16133270|NCT01910116|Drug|Shinbaro|GCSB-5 (Shinbaro) is a mixture of six purified oriental herb extracts in a fixed ratio, namely, Saposhnikovia divaricata Schischk, Glycine max Merrill, Cibotium barometz J. Smith, Eucommia ulmoides Oliver, Achyranthes japonica Nakai, and Acanthopanax sessiliflorus Seem
16133271|NCT01910116|Drug|Placebo|The study medication and placebo were identical in appearance.
16133272|NCT01910090|Drug|FLURBIPROFEN 100 mg FAMOTIDINE 20 mg MULTI-LAYER TABLET|MULTI-LAYER TABLET
16133273|NCT01910090|Drug|ANTADYS® 100 mg, PEPCID® 20 mg|ANTADYS® 100 mg, PEPCID® 20 mg two tablets, taken once
16133274|NCT01910077|Drug|Tacrobell capsule 1mg|1 capsule, oral, over the period I&II(crossover)
16133275|NCT01910077|Drug|Prograf capsule 1mg|1 capsule, oral, over the period I&II(crossover)
16133276|NCT01910064|Drug|GK530G|
16133277|NCT01910038|Drug|corticoids+ tocilizumab 8mg/Kg/4 weeks|
16133278|NCT01910025|Drug|ADI-PEG 20|
16133279|NCT01910012|Drug|ADI-PEG 20|
16133280|NCT01909999|Procedure|Osteogenic markers Evaluation|"The collection of peri-implant crevicular fluid (PICF) was performed immediately after implant insertion (Baseline) and after 7, 15, 30, 60, 90 and 120 days. The site to be collected was dried and isolated with sterile gauze. PICF was collected at four sites per implant using absorbent paper strips (Periopaper, Oralflow, Smithtown, New York). The volume of fluid was measured immediately with the aid of Periotron (Oraflow, Smithtown, New York) and conditioned at 400uL of PBS buffer + 0.05% Tween and then frozen at -80°C.
~The levels of the peri-implant osteogenic markers (OPG, OCN, OPN, TGF-α, and PTH) were determined using the LUMINEX/Magpix system (HBN1A-51K and HCCBP1MAG-58K, Millipore Corporation, Billerica, MA, USA)."
16133281|NCT01909999|Procedure|Clinical parameters evaluation|"The following parameters were assessed:
~Peri-implant sulcus depth (PISD): distance from the margin of the peri-implant mucosa to the bottom of the peri-implant sulcus;
~Modified Bleeding on Probing Index: the presence or absence of bleeding after 10 seconds on probing around implants."
16133282|NCT01909999|Procedure|Implant instalation|The surgeries, as well as all postoperative follow-up, were performed at the dental clinic of UNIP-SP. Surgical areas were anesthetized (2% mepivacaine with 1:100,000 epinephrine) and mucoperiosteal incisions in the alveolar ridge mucosa were made. The surgical sequence follow the protocol described by the implant company supplier of implants (SIN - São Paulo, SP, BR). In all cases, for maxilla rehabilitation, 6 implants were installed, while, for mandible, 5 were used.
16133283|NCT01909999|Procedure|Prosthesis installation|The patients in the IM Group received Brånemark protocol prosthesis within 3 days after the implant. The implants were first molded and the models sent for prosthesis confection (LABDENTAL, São Paulo, SP, Brazil). All prosthesis used straight mini-abutments (SIN, São Paulo, SP), that ranged from 1mm to 4mm in height, whose were tightened with 20N of torque, followed by occlusal adjustment and clinical monitoring
16133284|NCT01909999|Procedure|Suture|Soft tissues sutures were done using absorbable polygalactin 910 suture.
16133285|NCT01909999|Drug|Post-operative care|"Postoperative care were: amoxicillin 500 mg (8-8 hours/7 days); sodic dipyrone 500mg (6-6 hours/3 days); 0.12% Chlorhexidine mouthwash"
16133286|NCT01909986|Drug|[14C]ONO-4053|Single dose [14C]ONO-4053
16133287|NCT01909973|Behavioral|MedLink System|"Patient adherence to anti depressant medication will be accomplished by 1) monitoring adherence and providing feedback to patient (e.g. prompting patient to take medication); 2) monitoring side effects and treatment response and providing in-the-moment feedback and support; 3) activating the patient to take appropriate action (e.g. call the prescribing physician) based upon monitoring data; 4) providing standardized education and positive reinforcement to the patient.
~The care team will be supported and activated by being provided 1) suggested guideline-congruent actions and 2) timely information regarding the patient's status."
16133288|NCT01909960|Other|Flow imaging|"Quantitative flow study was performed by 2D phase-contrast velocity-encoded cine MRI (repetition/echo time, 15/7 ms; field of view = 140 x 140 mm²; matrix size = 256 x 128, flip angle = 25 degrees,one excitation, slice thickness = 5 mm). Cerebrospinal fluid and blood flows are measured with a velocity-encoding value of 5-10 cm/s and 80 cm/s respectively. Peripheral gating was used to cover the entire cardiac cycle with retrospective cardiac synchronization of 32 quantitative flow-encoded images per cycle.
~Clinical examination consists in Larson's score and MMSE"
16133289|NCT01909947|Other|Cardiorespiratory signal acquisition|"Cardiorespiratory signals will measure heart rate (using electrocardiography), chest and abdominal movements (using respiratory inductance plethysmography) and oxygen saturation (using pulse oximetry). Data will be acquired during 2 recording periods:
~A 60-minute period while the infant receives any mode of conventional mechanical ventilation
~A 5-minute period prior to extubation while the mode of ventilation is switched to endotracheal tube CPAP (Continuous Positive Airway Pressure), so that the respiratory pattern will be controlled by the infant"
16133290|NCT01909934|Drug|brentuximab vedotin|Brentuximab vedotin will be administered as a single intravenous (IV) infusion over 30 minutes on Day 1 of each 3 week cycle for up to a maximum of 16 cycles and should be administered for a minimum of 8 cycles for patients who achieve stable disease or better.
16133291|NCT01909908|Device|ECM|ECM in saline applied to wound
16133292|NCT01909908|Biological|Blood Products|Autologous blood product applied to wound, with saline cleanse on alternating weeks
16133293|NCT01909908|Device|ECM in Blood Products|Alternating treatments of ECM in saline and ECM in autologous blood products, applied to wound
16133294|NCT01909895|Other|Anger Induction|The participant is asked to recall an incident in the recent past during which they became moderately to extremely angry, or is asked to read statements out loud evoking moderate to extreme feelings of anger. The participant is asked to take a few moments to bring the details of the incident to mind and, when ready, to describe the incident in great detail to the experimenter. Participants are asked to describe key elements, such as any dialogue that transpired during the incident, along with other details of the incident, particularly regarding the feelings of that particular emotion experienced at the time. In so doing, the experimenter works to re-elicit the emotions that accompanied the original incident. The duration of the negative emotion induction task is 8 minutes.
16133297|NCT01909895|Other|Neutral emotion task|This is a neutral control task that each of the negation emotion induction tasks will be compared to.
16133298|NCT01909882|Other|Massage therapy|One session of massage therapy (for 60 minutes) was done by the patient's family member. Almond oil was used for effleurage and massage facilitation. Back, shoulder deltoid muscles, front and posterior parts of legs, arms, forearms, front and back parts of thighs, palms and fingers, metatarsus, front and back of feet and toes, belly and chest, auxiliaries and neck muscles of the patients were massaged. Massage techniques used included static massage, surface tension techniques, stretching massage, superficial lymph unload, transverse friction techniques, and myofacial releasing techniques. All the massage sessions were conducted in the morning shifts. For the control group, there was no intervention and patients just received the routine care of the unit.
16133299|NCT01909869|Device|EXCEL-Ⅱ|A PILOT First-In-Man Study to evaluate safety and efficacy of the EXCEL-Ⅱ with New Cobalt ChRomium Alloys Sirolimus Eluting BioDegradable Polymer Stent In the Treatment of Patients with de novo Coronary Artery Lesions
16133300|NCT01909856|Drug|Palonosetron|Palonosetron 0.25mg d1,d3
16133301|NCT01909856|Drug|Granisetron|Granisetron 3mg d1-3
16133302|NCT01909856|Drug|Dexamethasone|Dexamethasone 10mg d1-3
16133303|NCT01909856|Drug|Cisplatin|3-day chemotherapy regimens including cisplatin, cisplatin: 25mg/m2 d1-3
16133304|NCT01909843|Biological|ALX-0171|Escalating dose of ALX-0171 during maximum 3 consecutive days: from 2.1 mg to maximum 200 mg per inhaled dose followed by daily dose of 70 mg, 140 mg or 200 mg per dose for maximum 4 consecutive days
16133305|NCT01909830|Drug|Arm A : Gemcitabine + Pemetrexed|"Gemcitabine: 1000 mg/m2 by intravenous infusion over an exact period of 30' (preferably by a pump to guarantee a constant speed of infusion) on day 3 of each cycle repeated every 14 days.
~Pemetrexed: 150 mg/m2 by intravenous continuous infusion over an exact period of 8h on day 1 of each cycle repeated every 14 days."
16133306|NCT01909817|Procedure|Routine coronary angiogram|
16133307|NCT01909804|Drug|SOF|400 mg tablet administered orally once daily
16133308|NCT01909804|Drug|VEL|Tablet administered orally once daily
16133309|NCT01909804|Drug|RBV|200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16133310|NCT01909791|Procedure|Prompt Laser|Focal/grid laser performed at baseline and as needed during follow-up
16133311|NCT01909791|Drug|Prompt aflibercept|Intravitreal injection of 2.0mg aflibercept performed on the day of randomization and up to every 4 weeks using defined treatment criteria
16133312|NCT01909791|Procedure|Deferred laser|Focal/grid laser is initiated while receiving anti-VEGF injections only if certain criteria are met
16133313|NCT01909791|Drug|Deferred aflibercept|Intravitreal injection of 2.0mg aflibercept performed once certain criteria for vision loss are met and then up to every 4 weeks using defined treatment criteria
16133314|NCT01909778|Drug|BI 201335|single oral doses
16133315|NCT01909765|Other|Dorsal slit|Skin and mucosa incision made together
16133316|NCT01909765|Other|Double incision|Skin and mucosa incision made separately
16133317|NCT01909752|Drug|Cyclophosphamide|Cyclophosphamide (300 mg/m2) will be administered as a single dose three days prior to beginning vaccine therapy.
16133318|NCT01909752|Biological|DRibble vaccine|DRibble vaccine will be administered at Weeks 1, 4, 7, 10, 13, 16, 19, 25, 31, 37, and 43.
16133319|NCT01909752|Drug|Imiquimod|Imiquimod cream (5%, 250 mg containing 12.5 mg imiquimod - one packet/day) will be self applied once per day starting with the second vaccine (week 4). Immediately following vaccination and for four days following each vaccine cycle (total 5 days) imiquimod will be applied to a 4 x 5-cm outlined area of healthy extremity skin that includes the vaccine site.
16133320|NCT01909752|Drug|GM-CSF|GM-CSF will be administered at 50 mcg/day starting with the second vaccine (week 4) and continuing with each subsequent vaccine. A volume of 0.2 cc will be delivered by the CADD-MSTM 3 Ambulatory infusion pump at a rate of 0.008 cc/hr. The pump will be refilled after three days for a total of six days of infusion.
16133321|NCT01909752|Biological|HPV vaccine|Immunization with HPV vaccine will consist of two 0.5-mL intramuscular injection at the time of the first and third vaccinations. The preferred site of administration is the deltoid region of the upper arm.
16133322|NCT01909739|Drug|atrovastatin|Atrovastatin 80mg was administered orally on the evening before surgery. Before anesthesia induction, atrovastatin 40mg was administered orally. And atrovastatin 40mg were administered orally in the evening of postoperative days 0, 1, and 2.
16133323|NCT01909739|Drug|Placebo|Placebo 80mg was administered orally on the evening before surgery. Before anesthesia induction, placebo 40mg was administered orally. And placebo 40mg were administered orally in the evening of postoperative days 0, 1, and 2.
16133324|NCT01909726|Other|ScreenPlay|Interactive technology
16133325|NCT01909713|Drug|Facial Cleanser and Moisturizer SPF 30|Cetaphil® DermaControl™ Foam Wash and Moisturizer SPF 30
16133326|NCT01909700|Device|Single Incision Mesh|Single Incision Mesh is implanted for pelvic floor reconstruction
16133327|NCT01909687|Device|Blood glucose monitoring systems|
16133328|NCT01909674|Device|Switch CPAP mask type|
16133329|NCT01909661|Other|Damira/Celia peptide hydrolyzed casein|
16133330|NCT01909661|Other|Picot riz/Celia rice/Sanutri arroz|
16133331|NCT01909648|Other|Blood withdrawal|
16133332|NCT01909648|Genetic|Blood withdrawal|
16133333|NCT01909635|Behavioral|Food Feelings|
16133334|NCT01909635|Behavioral|Other Feelings|
16133335|NCT01909622|Dietary Supplement|Vitamin D|
16133336|NCT01909622|Dietary Supplement|No vitamin D|
16133337|NCT01909609|Other|AAP Documents|
16133338|NCT01909609|Other|Parent Survival Guide|
16133339|NCT01909596|Other|Without orthoses|Condition control
16133340|NCT01909596|Device|6° lateral wedge insoles|Insoles with a lateral inclination set at 6°
16133341|NCT01909596|Device|10° lateral wedge insoles|Insoles with a lateral inclination set at 10°
16133342|NCT01909596|Device|Neutral customized foot orthoses|Foot orthoses with arch support and without lateral inclination
16133343|NCT01909596|Device|6° lateral customized foot orthoses|Foot orthoses with arch support above insoles with lateral inclination set at 6°
16133344|NCT01909596|Device|7° lateral customized foot orthoses|Foot orthoses with arch support above insoles with lateral inclination set at 7°
16133345|NCT01909596|Device|8° lateral customized foot orthoses|Foot orthoses with arch support above insoles with lateral inclination set at 8°
16133346|NCT01909596|Device|9° lateral customized foot orthoses|Foot orthoses with arch support above insoles with lateral inclination set at 9°
16133347|NCT01909596|Device|10° lateral customized foot orthoses|Foot orthoses with arch support above insoles with lateral inclination set at 10°
16133348|NCT01909596|Device|Orthotist integrated lateral customized foot orthoses|Foot orthoses with arch support and integrated lateral inclination set according to orthotist experience
16133349|NCT01909596|Device|Orthotist lateral customized foot orthoses|Foot orthoses with arch support above insoles with lateral inclination set according to orthotist experience
16133350|NCT01909583|Other|STAGES-Booklet|STAGES-booklet was designed by the investigators focussing on guiding parents through the pre-operative and operative admission period.
16133351|NCT01909570|Procedure|Elective single embryo transfer|After the FIV/ICSI procedure, the embryo transfer in this arm would be of one embryo followed by the cryotransfer of one embryo in case of no conception in the fresh cycle.
16133352|NCT01909570|Procedure|Double embryo transfer|After the FIV/ICSI procedure, the embryo transfer in this arm would be of two fresh embryos
16133353|NCT01909557|Drug|Acetyl-L-carnitine|
16133354|NCT01909557|Drug|placebo|
16133355|NCT01909544|Other|Fatiguing exercise|All participants (patients and healthy subjects) will perform the exercise both under normoxic (FiO2 = 0.21) and hyperoxic conditions (FiO2 = 100%)
16133356|NCT01909492|Procedure|Blood Draw|Patients will provide a serum sample for research.
16133357|NCT01909492|Procedure|Lumbar Puncture|Patients will have a lumbar puncture to obtain CSF.
16133358|NCT01909479|Drug|MOD-4023|Individualized once weekly dose of MOD-4023
16133359|NCT01909479|Other|Placebo|Once weekly administration of placebo
16133360|NCT01909466|Drug|Aripiprazole, OPC-14597|5 monthly applications of 400 mg of aripiprazole IM depot, where the first application is in the gluteal or deltoid muscle followed by 4 monthly administrations to the deltoid muscle
16133364|NCT01909440|Behavioral|exercise intervention|Receive whole body RT
16133365|NCT01909440|Dietary Supplement|nutritional supplementation|Given whey protein supplementation PO
16133366|NCT01909440|Procedure|quality-of-life assessment|Ancillary studies
16133367|NCT01909440|Other|questionnaire administration|Ancillary studies
16133368|NCT01909440|Other|pharmacological study|Correlative studies
16133369|NCT01909440|Other|laboratory biomarker analysis|Correlative studies
16133370|NCT01909427|Drug|Placebo|Placebo subcutaneous injections (SC) every 4 weeks through Week 12
16133371|NCT01909427|Drug|CNTO 6785 200 mg|CNTO 6785 200 mg SC every 4 weeks from Week 16 through Week 28
16133372|NCT01909427|Drug|CNTO 6785 200 mg|CNTO 6785 200 mg SC every 4 weeks through Week 28
16133373|NCT01909427|Drug|CNTO 6785 100 mg|CNTO 6785 100 mg SC every 4 weeks through Week 28
16133374|NCT01909427|Drug|CNTO 6785 50 mg|CNTO 6785 50 mg SC every 4 weeks through Week 28
16133375|NCT01909427|Drug|CNTO 6785 15 mg|CNTO 6785 15 mg SC every 4 weeks through Week 28
16133376|NCT01909427|Drug|Methotrexate (MTX)|MTX at the same stable dose through Week 32, that participants were receiving prior to screening.
16133377|NCT01909414|Biological|GEO-D03 DNA Vaccine|DNA GEO-D03 vaccine will be administered as a 3 mg dose IM.
16133378|NCT01909414|Biological|MVA/HIV62B Vaccine|MVA/HIV62B vaccine will be administered as a 1 x 10^8 TCID50 dose IM.
16133379|NCT01909414|Biological|Placebo for DNA GEO-D03|Placebo for DNA GEO-D03 (administered as 0.9 percent Sodium Chloride for Injection) will be administered IM.
16133380|NCT01909414|Biological|Placebo for MVA/HIV62B Vaccine|Placebo for MVA/HIV62B 1 x 10^8 TCID50 (administered as 0.9 percent Sodium Chloride for Injection) will be administered IM.
16133381|NCT01909401|Drug|boceprevir|
16133382|NCT01909388|Radiation|MRI-TRUS fusion guided real time HDR|
16133383|NCT01909349|Behavioral|self-regulation|Web-based support for behavior change regarding physical activity and fruit & vegetable consumption
16133384|NCT01909336|Drug|0.3% Saline in 3.3% dextrose|Hypotonic Solutions: 0.3% Saline in 3.3% dextrose
16133385|NCT01909336|Drug|0.45% Saline in 5% dextrose|Hypotonic Solutions: 0.45% Saline in 5% dextrose
16133386|NCT01909336|Drug|0.9% Saline in 5% dextrose|Isotonic Solutions 0.9% Saline in 5% dextrose
16133387|NCT01909323|Other|maltitol 85% / FOS15%|
16133388|NCT01909323|Other|maltitol alone|
16133389|NCT01909323|Other|maltitol 68% / FOS 32%|
16133390|NCT01909323|Other|maltitol 50% / FOS 50%|
16133391|NCT01909323|Other|FOS alone|
16133392|NCT01909323|Other|Placebo|
16133393|NCT01909310|Procedure|head extension|the lungs are ventilated with the patient´s head extended
16133394|NCT01909310|Procedure|neutral position|the lungs are ventilated with the patient´s head in neutral position
16133395|NCT01909310|Procedure|anaesthesiologist´s position|the lungs are ventilated with the patient´s head positioned deemed ideal by the anaesthesiologist
16133396|NCT01909297|Device|PROSEAL LMA|Size 3,4 or 5 supraglottic device with orogastric drainage tube
16133397|NCT01909297|Device|SUPREMA LMA|Size 3,4 or 5, disposable supraglottic device with orogastric drainage tube
16133398|NCT01909297|Device|I-GEL LMA|Size 3,4,5 disposable supraglottic device with noninflatable cuff
16133399|NCT01909284|Device|Acupuncture|"BL40, BL60, ST36, GB34 : bilaterally, manual acupuncture.
~Two points on 1st bladder meridian nearest location of back pain : bilaterally, electrical acupuncture."
16133400|NCT01909284|Procedure|Epidural nerve block|Lumbar nerve block will be performed by using the mixture of dexamethasone (5mg) and mepivacaine (10mg).
16133401|NCT01909271|Behavioral|Stroke Education Film Viewing|A novel, culturally tailored intervention using storytelling (narrative persuasion) in the form of two professionally produced 12-min films (in English and Spanish), in minority populations in New York City.
16133402|NCT01909271|Other|Stroke Education Pamphlet Exposure|"Usual Care: Stroke Education pamphlet and brochure distribution."
16133507|NCT01908634|Dietary Supplement|Milk-based strawberry Beverage with meal|
16133403|NCT01909258|Other|Goniometric measure of pelvic extension reserve.|"The pelvic extension reserve (°) is measured via goniometry.
~The goniometric measurements will be taken once by an investigator on all subjects and once by a different investigator on half of the subjects (with balanced distribution of morphotypes)."
16133404|NCT01909258|Other|Photographic measure of pelvic extension reserve.|"The pelvic extension reserve (°) is measured using photography.
~Photographic measurements will be performed twice one investigator and 1 time by a different investigator (total of three measurements)."
16133405|NCT01909258|Other|EOS measure of pelvic extension reserve.|"The pelvic extension reserve (°) is measured using the imaging system EOS.
~Five X-rays will be made for each volunteer on the EOS system. The first is a frontal shot in a bipedal position, reference snapshot for verifying the absence of spinal deformity or hip pathology. The second and third are profile shots, one on the left and one on the right, whole body, bipedal position; serving as a reference picture. The fourth is profile shot, whole body, with the left hip in hyperextension. For maximum left hip hyperextension, the right leg rests on a step of varying height, and the hip is maximally flexed. The fifth is a profile shot, full body, with the right hip in hyperextension. For a maximum right hip hyperextension, the left leg rests on a step of varying height, and the hip is maximally flexed."
16133406|NCT01909245|Biological|Allogenic Human Islet Cells|Intraportal (into the liver) infusion of islet cells, with a maximum of three islet transplants.
16133407|NCT01909245|Drug|Immunosuppressive Agents|Anti-rejection medications (to prevent the body from rejecting the islet cells) and other medications to guard against infection and support participant health and/or the health of the transplanted islets.
16133408|NCT01909245|Drug|Gastrin 17|Gastrin-17 (or GAST-17) - a gut hormone injected under the skin for 30 days (optional treatment for islet dysfunction).
16133409|NCT01909232|Device|Active Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator|The Cervel Neurotech multi-coil transcranial magnetic stimulator is an investigational repetitive transcranial stimulation (rTMS) device. In the active group, magnetic power output will be delivered to the subject through the coils.
16133410|NCT01909232|Device|Inactive Cervel Neurotech Multi-Coil Transcranial Magnetic Stimulator|The Cervel Neurotech multi-coil transcranial magnetic stimulator is an investigational repetitive transcranial stimulation (rTMS) device. In the inactive group, no magnetic power output will be delivered to the subject through the coils.
16133411|NCT01909219|Drug|Sodium picosulphate/magnesium Citrate|Comparison of two different dosing regimens of sodium picosulphate/magnesium citrate
16133412|NCT01909193|Behavioral|Attention Bias Modification (ABM)|Attention training via 8 weekly repeated trials of a dot-probe task intended to direct attention away from threat stimuli.
16133413|NCT01909193|Behavioral|Cognitive Behavior Therapy|CBT will consist of 16-20 weekly individual treatment sessions aimed to reduce symptoms via cognitive and behavioral interventions
16133414|NCT01909180|Device|Revolution CT Scanner|"These scans would be considered standard of care but, because the subjects are scanned on an uncleared device they are investigational."
16133415|NCT01909167|Behavioral|Online Cognitive Behavioral Therapy (CBT)|CBT treatment: Patients randomized to the online treatment will have, in total, 10 real time individual sessions of 40min each, starting at the 20-23rd gestational week and lasting until 6 weeks postpartum. The therapy will be delivered every two weeks, with a break from the 36th gestational week until the 4th week postpartum.
16133416|NCT01909167|Other|Treatment as usual|Patients randomized to the treatment as usual arm will be advised by their GP,perinatal psychiatric team or mental health midwife concerning treatment.
16133417|NCT01909154|Biological|Mesenchymal stromal cell therapy|Stem cells administration locally
16133418|NCT01909141|Drug|induction of ovulation using letrozole-pioglitazone-metformin|induction of ovulation will be done for arm 1 for 3 consecutive cycles unless pregnancy occured.
16133419|NCT01909141|Drug|induction of ovulation using clomiphene citrate-pioglitazone-metformin|induction of ovulation for arm 2 will be done in 3 consecutive cycles unless pregnancy occured.
16133420|NCT01909141|Radiation|transvaginal ultrasound|transvaginal ultrasound will be done starting from day 10 and every 48 hours until finding a follicle of > 18 mm or till day 20 of the cycle
16133421|NCT01909141|Other|body mass index (BMI) calculation|BMI will be calculated for all women by dividing the weight in kilograms by the height in meters squared
16133422|NCT01909141|Other|day 3: follicle stimulating hormone (FSH), luteinizing hormone (LH), thyroid stimulating hormone (TSH), total testosterone|baseline hormonal assay (day 3 FSH, LH, TSH and total testosterone) will be done for all women.
16133423|NCT01909141|Other|pretreatment blood urea and serum creatinine|blood urea and serum creatinine will be assayed before stating induction of ovulation to have baseline levels.
16133424|NCT01909141|Other|serum estradiol (E2) on day 12|serum E2 will be assayed on day 12 of the cycle for all women.
16133425|NCT01909141|Other|serum progesterone on day 21|serum progesterone will be assayed on day 21 for all women to monitor ovulation.
16133426|NCT01909141|Other|blood urea and serum creatinine every month|blood urea and serum creatinine will be assayed every month during the treatment period to find out any hazards on kidney functions
16133427|NCT01909128|Dietary Supplement|fermented milk|fermented milk with Lactobacillus CBA-L74
16133428|NCT01909128|Dietary Supplement|fermented rice|fermented rice wit Lactobacillus CBA-L74
16133429|NCT01909115|Drug|1000 IU of Vitamin D3|1000 IU of Vitamin D will be administered in capsule form, once daily.
16133430|NCT01909115|Drug|4000 IU of Vitamin D3|4000 IU of Vitamin D will be administered in capsule form, once daily.
16133431|NCT01909102|Behavioral|ACT-based intervention|
16133432|NCT01909102|Behavioral|usual care|
16133433|NCT01909089|Drug|Spinal administration of chloroprocaine.|"In order to determine the minimum effective dose that is to be given spinally, an up-down sequential allocation will be used.
~Efficacy of the analgesia will be evaluated by a 100mm visual analogue pain score (VAPS). There are two possible outcomes here:
~effective: the VAPS is 10mm or lower after the 15 minutes of monitoring. An effective result will decrease the test dose of chloroprocaine with 2mg for the next patient in this study.
~Ineffective: the VAPS is more than 10mm after 15 minutes of monitoring. An ineffective result will increase the test dose of chloroprocaine with 2mg for the next patient in this study. Patients who indicate an ineffective result will receive a rescue treatment by the administration of 12ml levobupivacaine epidurally."
16133508|NCT01908634|Dietary Supplement|Water-Based strawberry Beverage with meal|
16133434|NCT01909076|Behavioral|Electronic decision support tools|"Electronic decision support tools available to both control and intervention PCPs include patient pain assessments, (Brief Pain Inventory, Pain/Enjoyment/General Function PEG), substance abuse (DAST, AUDIT) depression (PHQ9), PTSD (PTSD ChecklistCivilian), and risk of prescription drug misuse (SOAPP and COMM). The tools calculate scores with recommendation for specific action for each tool, when appropriate."
16133435|NCT01909076|Behavioral|Enhanced patient education materials|Patient education materials will be developed and made available to both control and intervention patients. The investigators will design the materials for patients with low literacy, using pictures and simple graphics to augment written language. The research staff will make PDFs of the materials available on the study website during and after the project.
16133436|NCT01909076|Behavioral|Nurse care management|The nurse/care management intervention will be modeled on BMC's successful collaborative care office-based opioid treatment (OBOT) program. One fulltime nurse care manager will work with PCPs assigned to the intervention condition. The care manager will be based centrally, in the Section of General Internal Medicine, and will divide his/her time between the 3 health centers. The main focus of the nurse care manager is to assure that patients are receiving guideline-adherent care, which involves appropriate clinical assessments, opioid treatment agreements, refill management, administering monitoring tools according to risk level (urine toxicology screen, pill counts, PMP data extraction) and timely physician visits to assess pain (minimum every 6 months).
16133437|NCT01909076|Behavioral|Electronic Patient Registry|The registry will be a freestanding centralized disease management application and built using standard database technology. This system will communicate with the electronic medical record (EMR) at each community health center and with the Massachusetts State Prescription Monitoring Program (PMP) system. Data that will feed into the registry include clinical data recorded from the EMR (documentation from other clinicians and labs), data from clinical users entered into the registry via pain and opioid management forms, and the PMP. The nurse care manager will use a custom registry interface to monitor key practice activities across the entire practice at each site. The nurse care manager will use population management tools to provide aggregate measures for quality monitoring and workforce management. All quality metrics can be downloaded in aggregate form for further analysis.
16133438|NCT01909076|Behavioral|Academic detailing|All PCPs in the intervention group will receive one 30 minute individual visit 23 months after project implementation at the PCP's practice site. The visits will be conducted with at least one of the study experts in pain medication management. Visit content will combine elements of audit and feedback (e.g. review registry of individual PCP compared with that of peers and goals) as well as traditional educational outreach. Specifically, experts will review each aspect of guideline concordant care (assessment of risk and appropriateness for opioid medication, medication dosing, monitoring for harm/adherence, and pain outcomes) to solicit barriers to implementation or lack of knowledge on the underlying evidence for each aspect of care. The experts will work with the individual PCPs to address barriers identified using motivational interviewing as needed to facilitate behavioral change in applying guideline concordant care.
16133439|NCT01909063|Dietary Supplement|Vitamin D|Fortification of orange juice with 200 IU vitamin D to be drunk twice per day for 12 weeks
16133440|NCT01909063|Dietary Supplement|Vitamin D, Vitamin E, and Vitamin A|Fortification of orange juice with Vitamin D, Vitamin E, and Vitamin A to be drunk twice per day for 12 weeks
16133441|NCT01909063|Dietary Supplement|Control, 700 mg Calcium|Orange juice with 700 mg calcium to be drunk twice per day for 12 weeks
16133442|NCT01909037|Dietary Supplement|Flexofytol (bio-optimized curcumin)|2x3 caps/day (before breakfast and in the evening) for 3 months
16133443|NCT01909024|Procedure|Coil embolisation|transjugular coil embolisation of pelvic veins
16133444|NCT01909024|Procedure|endovenous treatment of leg recurrent varicose veins|endovenous treatment of leg recurrent varicose veins
16133445|NCT01909011|Device|Active CES|The active CES treatment group will receive the following dose of CES delivered over the temples bilaterally: 2mA of alternating current qt 1Hz, 5Hz, and 15,000Hz for one 20 minute session per day for 5 times per week for four weeks.
16133446|NCT01909011|Device|Sham CES|The CES sham group will receive sham CES (device off) for 20 minutes 5 times per week for two weeks.
16133447|NCT01908998|Other|Sandal|Subjectes will be scored on the Y-Balance Test wearing an Orthaheel Sandal
16133448|NCT01908985|Procedure|high intensity focused ultrasound for cyclodestruction in the eye|
16133449|NCT01908972|Drug|Prednisolone|2mg/kg/day for 16weeks
16133450|NCT01908972|Drug|Propranolol|2mg/kg/day for 16weeks
16133451|NCT01908959|Behavioral|Madres para la Salud|Participants attended Madres para la Salud sessions in a group, led by a promotora at the Maricopa Medical Center and other community based sites. Sessions consisted of a 30 minute education and social support session where women learned to walk at least 150 minutes a week at a 20 minute-mile pace, and up to 30 minutes of moderate intensity walking with the group. Participants received a pedometer and learned to monitor their walking intensity. Participants set and reviewed weekly walking goals at the group sessions and recorded aerobic steps per day. After the 12 week sessions, participants met with the promotora once a week for 40 weeks of in-group walking at a moderate intensity for 30 minutes, to download and review pedometer data. Data was collected at baseline, 3, 6, 9 and 12 months.
16133452|NCT01908946|Behavioral|SMS reminders|SMS reminders for vaccination visit at 6, 10 and 14 weeks of life.
16133453|NCT01908933|Device|AeriSeal Emphysematous Lung Sealant Syst|This is a prospective, open label, single-arm, multicenter, investigational study. Patients will receive either unilateral or bilateral AeriSeal System therapy as appropriate utilizing 20 mL/subsegment dosing at 2 to 4 subsegments.
16133454|NCT01908920|Other|Osteopathic manipulative treatment|
16133455|NCT01908920|Other|SHAM|
16133456|NCT01908920|Other|CONTROL|
16133457|NCT01908907|Dietary Supplement|DHA oil|Therapy Group:DHA oil administered at 50 mg/d (0.18ml) as an oil emulsion enterally with feedings or by gavage tube if the infant has one.
16133458|NCT01908907|Dietary Supplement|(MCT) Control oil|Placebo Group:MCT oil administered at 0.18 ml as an oil emulsion enterally with feedings or by gavage tube if the infant has one.
16133459|NCT01908894|Drug|BIOD-123|
16133460|NCT01908894|Drug|BIOD-125|
16133461|NCT01908894|Drug|Humalog|
16133509|NCT01908621|Drug|G-CSF (filgrastim)|
16133510|NCT01908621|Drug|Cytosine arabinoside + G-CSF (filgrastim)|
16133511|NCT01908595|Drug|M518101|
16133462|NCT01908881|Behavioral|Group Workshop|The intervention consists in a group workshop (for up to 7 dyads with children aged between 6 and 12 months and two health care professional monitors) of four sessions of two hours each, held weekly. One of the sessions is characterized as including the fathers or other caregivers relevant to the upbringing of the children. Each session is structured around various activities that specifically deal with the skills associated with parental sensitivity and address relevant issues to child rearing, considering the development of the child.
16133463|NCT01908881|Behavioral|Usual Care|"According to the screening carried out various interventions are offered by Primary Health Care centers (eg. home visits) in the Chile Crece Contigo Program. During pregnancy, if the mother is screened for positive psychosocial risk she would receive different interventions consisting in (usual care at Primary Health Care Centers): home visits, evaluation by social worker and planning interventions according to a multidisciplinary team."
16133464|NCT01908868|Other|EBUS-TBNA|Mediastinal and hilar lymph node aspiration using endobronchial ultrasound
16133465|NCT01908868|Other|Conventional TBNA|Mediastinal and hilar lymph node aspiration using blind transbronchial needle aspiration
16133466|NCT01908868|Other|Endobronchial and transbronchial biopsy|Endobronchial and transbronchial lung biopsy using flexible bronchoscopy
16133467|NCT01908855|Behavioral|Cognitive-behavioral therapy + emotion regulation training for patients with multiple somatoform symptoms|"Cognitive-behavioral therapy + emotion regulation training for patients with multiple somatoform symptoms:
~20 weekly sessions individual therapy (à 50) minutes"
16133468|NCT01908855|Behavioral|Cognitive-behavioral therapy for patients with multiple somatoform symptoms|"Cognitive-behavioral therapy for patients with multiple somatoform symptoms:
~20 weekly sessions individual therapy (à 50) minutes"
16133469|NCT01908842|Drug|BNX sublingual tablets|Buprenorphine/naloxone sublingual tablets
16133470|NCT01908842|Drug|BNX sublingual film|Buprenorphine/naloxone sublingual film
16133471|NCT01908842|Drug|Buprenorphine|Buprenorphine sublingual tablets
16133472|NCT01908829|Drug|mirabegron 25 mg|Mirabegron was supplied as the marketed formulation in the 25 mg OCAS (Oral Controlled Absorption System) modified release tablets. Medication was taken orally with a glass of water, with or without food.
16133473|NCT01908829|Drug|mirabegron 50 mg|Mirabegron was supplied as the marketed formulation in the 50 mg OCAS (Oral Controlled Absorption System) modified release tablets. Medication was taken orally with a glass of water, with or without food.
16133474|NCT01908829|Drug|solifenacin 5 mg|Solifenacin was provided as the marketed formulation in the 5 mg strength. Medication was taken orally with a glass of water, with or without food.
16133475|NCT01908829|Drug|solifenacin 10 mg|Solifenacin was provided as the marketed formulation in the 10 mg strength. Medication was taken orally with a glass of water, with or without food.
16133476|NCT01908829|Drug|mirabegron 25 mg matching placebo|Matching placebo of mirabegron OCAS 25 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.
16133477|NCT01908829|Drug|mirabegron 50 mg matching placebo|Matching placebo of mirabegron OCAS 50 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.
16133478|NCT01908829|Drug|solifenacin 5 mg matching placebo|Matching placebo of solifenacin succinate 5 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.
16133479|NCT01908829|Drug|solifenacin 10 mg matching placebo|Matching placebo of solifenacin succinate 10 mg tablets was supplied. Medication was taken orally with a glass of water, with or without food.
16133480|NCT01908816|Drug|ranibizumab|One injection of Ranibizumab 0.5 mg and retreatment according to disease activity and/or visual impairment on an as needed regimen (PRN)
16133481|NCT01908803|Drug|AL-60371/AL-817 otic suspension|
16133482|NCT01908803|Drug|Ciprofloxacin 0.3%/dexamethasone 0.1% otic suspension|CIPRODEX®
16133483|NCT01908790|Device|Mespere Venous Oximeter|The Mespere VA Oximeter System is a non-invasive medical device for measurement of venous blood oxygenation.
16133484|NCT01908790|Device|Avoximeter 4000|The portable Avoximeter 4000 provides rapid, accurate assessment of the patient's true oxygenation status at the bedside. Features: Results in less than 10 seconds; No sample preparation required; Uses whole blood sample; Easy to use.
16133486|NCT01908764|Drug|AL-60371 otic suspension|
16133487|NCT01908751|Procedure|Sliding Hip Screw|
16133488|NCT01908751|Procedure|Cancellous Screws|
16133489|NCT01908751|Drug|Vitamin D|
16133490|NCT01908751|Drug|Vitamin D Placebo|
16133491|NCT01908738|Drug|paracervical block with 1%lidocaine|"To determine effectiveness of paracervical block, lidocaine spray and only oral analgesic drugs for pain relief during endometrial biopsy.
~Pain score(NRS) immediately after procedure and 15 minutes Group 1(1%Lidocaine) Group 2(10%Lidocaine spray) Control group(Placebo) Pain score immediately Pain score 15 minutes"
16133492|NCT01908738|Drug|10%lidocaine spray|
16133493|NCT01908725|Drug|Lamazym|ERT, i.v. infusions weekly
16133494|NCT01908712|Drug|Lamazym|ERT, i.v. infusions weekly
16133495|NCT01908699|Drug|Beraprost Sodium 314d Modified Release Tablets|Available as 15 μg tablets for oral, 1 or 2 tablets four times daily (QID) administration
16133496|NCT01908699|Drug|Placebo|Placebo tablets, which are identical in size and appearance to those containing BPS-314d-MR
16133497|NCT01908686|Behavioral|Pivotal Response Training|Behavioral intervention for autism
16133498|NCT01908673|Behavioral|HRV biofeedback|
16133499|NCT01908673|Behavioral|ASTM|
16133500|NCT01908660|Drug|antiretroviral drugs|zidovudine lamivudine emtricitabine abacavir tenofovir nevirapine efavirenz etravirine rilpivirine lopinavir atazanavir fosamprenavir darunavir raltegravir maraviroc ritonavir
16133501|NCT01908647|Behavioral|RT fMRI|Real-time fMRI with neurofeedback.
16133502|NCT01908647|Behavioral|Cognitive Training|Computer based attention training.
16133503|NCT01908647|Behavioral|Control RT fMRI|Control condition for real-time fMRI.
16133504|NCT01908647|Behavioral|Control Cognitive Training|Computer-based games used as a control for the computer based cognitive training intervention.
16133505|NCT01908634|Dietary Supplement|Milk-based Strawberry Beverage without meal|
16133506|NCT01908634|Dietary Supplement|Water-Based Strawberry Beverage without meal|
16133514|NCT01908569|Other|MACS|The sperm will be subjected to capacitation through a density gradient together with the MACS technique in order to select the non-apoptotic spermatozoids.
16133515|NCT01908569|Other|NO MACS|The sperm capacitation will be performed through a density gradient. The MACS technique will not be applied.
16133516|NCT01908556|Drug|Letrozole|
16133517|NCT01908543|Drug|Ferrous sulphate 200mg oral tablet|Administration by mouth
16133518|NCT01908530|Device|Microprobe glucose sensor|Assessment of safety and accuracy of a novel continuous glucose monitor based on microprobe technology.
16133519|NCT01908517|Behavioral|HPV Vaccine Electronic Reminders|The intervention group will receive 4 education messages, 2 reminder/education messages, as well as 1 baseline and 1 final assessment survey. Control group participants will receive 2 contacts throughout the study, 1 at baseline and 1 at their final assessment survey. Up to two reminder contacts will be used if surveys are not completed for both intervention and control group participants. Preference for receipt of reminders will be obtained from the information study card parents complete at study enrollment. Enrollment card content, educational messages and patient- reminders will all be developed with community input.
16133520|NCT01908504|Other|PET-CT|At radiation planning subjects will have a PET-CT. The CT scan - also called computerized tomography or just CT - combines a series of X-ray views taken from many different angles to produce cross-sectional images of the bones and soft tissues inside the body. A PET is a highly specialized imaging technique that uses short-lived radioactive substances (such as FDG a simple sugar labeled with a radioactive atom) to produce three-dimensional colored images of those substances functioning within the body. These images are called PET scans and the technique is termed PET scanning. PET scanning provides information about the body's chemistry not available through other procedures. Unlike CT or MRI (magnetic resonance imaging), techniques that look at anatomy or body form, PET studies metabolic activity or body function.
16133521|NCT01908491|Device|IV PCA|On arrival in the postanesthetic care unit, a patient-controlled analgesia (IV PCA) was connected to the iv catheter. The PCA regimen consisted of hydromorphone (2 mcg/kg/hr) and ketorolac (0.02 mg/kg/hr) with normal saline (total volume 100ml). PCA was programmed to deliver 1 ml/hr as background infusion and 1 ml per demand with a 10 min lockout during 48 hr period.
16133522|NCT01908491|Device|Continuous wound infusion|Patients underwent insertion of wound catheters by the surgeon just before the closure of incision site. The wound catheters, consisting of double branch and connected to elastomeric pump filled with ropivacaine (0.15~0.25%) and administered at a constant flow rate of 2 ml/hr in each branch of the catheter for 48 hr.
16133523|NCT01908478|Drug|Veliparib|
16133524|NCT01908478|Drug|Gemcitabine|
16133525|NCT01908478|Radiation|Intensity modulated radiation therapy|
16133526|NCT01908465|Drug|Ebastine|
16133527|NCT01908465|Drug|Placebo|
16133528|NCT01908452|Drug|Pyridoxine|1200 mg/d during 12 weeks
16133529|NCT01908439|Other|whole-body vibration|High amplitude whole-body vibration
16133530|NCT01908426|Drug|Cabozantinib tablets|
16133531|NCT01908426|Drug|Placebo tablets|
16133532|NCT01908413|Drug|CUDC-427|CUDC-427 as an oral formulation administered daily on a 14 days on/7 days off schedule
16133533|NCT01908400|Biological|Intravenous transfer of BMMNC|Intervention therapy , Total 3 doses ,in 30 days ,in 7days interval Intravenous transfer of Autologous Bone Marrow derived Mono Nuclear Stem Cell (BMMNCs)
16133534|NCT01908387|Drug|Oral azacitidine|100 mg to 300 mg oral azacitidine once daily for 14 days or 21 days of the initial 28-day cycle
16133535|NCT01908374|Dietary Supplement|DHA-rich fish oil versus Phospholipid-rich fish oil|This randomized, controlled crossover study will include four treatment visits (visits 2, 3, 4, and 5; days 0, 14, 42, and 56). Subjects will be randomly assigned, by sex and age, to their first treatment study product (active or control), which will be administered with a standardized low-choline, DHA-, EPA- free breakfast meal at t = 0 h. Subjects will consume placebo or phospholipid-rich fish oil for two weeks, washed out for 4 weeks, then treatments switched. Blood samples will be obtained for acute measurements on visits 2 and 4, via an indwelling venous catheter or venipuncture at t = 1, 2, 4, 6, 8, 10, and 12 h ± 5 min, to determine plasma fatty acid profile. Chronic fatty acid measurements will be determined after 2 weeks on visits 3 and 5.
16133536|NCT01908361|Behavioral|Unilateral Hybrid (InMotion3 plus CIT) Intervention|"During the 3-week InMotion3 period, participants will receive 5 minutes of muscle tone normalization preparation and passive range of motion, then 85 minutes of training using the InMotion3 robot. The participants will practice about 5 to 8 minutes of passive, 30 to 35 minutes of assisted-active, and 5 to 8 minutes of active motions in wrist and forearm, respectively.
~During the 3-week CIT period, participants will receive intensive training of the affected UL in functional tasks with behavioral shaping for 1.5 hours/weekday and will be asked to wear a mitt to restrict the unaffected UL for 6 hours daily. The shaping techniques will involve individualized task selection, graded task difficulty, verbal feedback, prompting, physical assistance with movements, and modeling. Caregivers will use daily logs to document hours of mitt wearing outside the one-on-one intervention sessions."
16133537|NCT01908361|Behavioral|Bilateral Hybrid (BMT plus BAT) Intervention|"During the 3-week BMT period, patients will play a simple computer game (e.g., picking up apples) that tracks patient movements to provide instant visual feedback. The therapist will also provide verbal feedback. In each training session, the patient will practice 600 to 800 repetitions of passive-passive mode for 15 minutes, 600 to 800 repetitions of active-passive mode for 15 to 20 minutes, and 150 to 200 repetitions of active-active mode for 5 minutes, respectively, for the forearm pronation-supination and the wrist flexion-extension.
~During the 3-week BAT period, participants will receive training in tasks focusing on bilateral symmetric or alternating movements of both ULs, such as lifting two cups, picking up two pegs, grasping and releasing two towels, and wiping the table with both hands."
16133538|NCT01908361|Behavioral|Conventional Rehabilitation|Participants in CR group will receive therapist-mediated functional tasks training based on neurodevelopmental techniques with emphasis on functional tasks and muscle strengthening that will involve (1) active/passive range of motions, abnormal muscle tone/reflex inhibition techniques (such as stretching and/or weight bearing), and strengthening of affected arm for 15 to 20 minutes, (2) functional tasks for training fine motor or manual dexterity for 20 minutes, and (3) activities of daily living or functional tasks involving gross motor activities, coordination tasks, transition, mobility, and posture/balance for 15 to 20 minutes. The activities will be individualized according to the level of impairment and the needs of the patients.
16133540|NCT01908335|Drug|PEG-IFN-SA /RBV low dose|24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3
16133541|NCT01908335|Drug|PEG-IFN-SA /RBV middle dose|24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3
16133542|NCT01908335|Drug|PEG-IFN-SA /RBV high dose|24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3
16133543|NCT01908335|Drug|Pegasys /RBV|24 weeks for genotype 2,3 and 48 weeks for non-genotype2,3
16133544|NCT01908322|Drug|Sorafenib (Nexavar, BAY43-9006)|Patients will be followed-up from start of Nexavar therapy until death or drop out due to any reason or end of study
16133545|NCT01908309|Drug|Iobitridol 350|
16133546|NCT01908309|Drug|Iodixanol 320|
16133547|NCT01908296|Drug|FK949E|Oral
16133548|NCT01908296|Drug|fluvoxamine|Oral
16133549|NCT01908283|Biological|13-valent pneumococcal conjugated vaccine (PCV13)|Immunization with 1 dose of PCV13 (=0.5ml) intra-muscular
16133550|NCT01908270|Behavioral|Yoga|
16133551|NCT01908270|Other|Usual care|
16133552|NCT01908257|Drug|lesinurad 400 mg|
16133553|NCT01908257|Drug|ranitidine 150 mg|
16133554|NCT01908257|Drug|lesinurad 400 mg + ranitidine 150 mg|
16133555|NCT01908244|Other|Music|Pentatonic music
16133556|NCT01908205|Drug|Intranasal Oxytocin|
16133557|NCT01908205|Drug|Placebo|
16133558|NCT01908192|Drug|NaBen®|The Study Treatment is NaBen®, which will look, and will be packaged and maintained exactly the same way as the Control Treatment (Placebo).
16133559|NCT01908192|Drug|Placebo|The ingredients in the Control Treatment are exactly the same as in the Study Treatment, except without the primary active ingredient.
16133560|NCT01908166|Procedure|ultrasound elasticity imaging|Undergo ultrasound elastography
16133561|NCT01908140|Drug|Aclidinium Bromide / Formoterol Fumarate|
16133562|NCT01908140|Drug|Salmeterol / Fluticasone|
16133563|NCT01908127|Behavioral|tell- show- do|Children came in the operation room. Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed by the dentist for each participant to increase their familiarity with dental procedures. The duration of the appointment was about 20 minutes and constant for all children.
16133564|NCT01908127|Behavioral|film modelling|the children were directed to a quiet and comfort room to watch a film presented by a dental assistant. The film showed that the same procedure consisted of Tell-Show-Do, prophylaxis with paste and rubber cap and fluoride therapy was performed on a 5-years-old child model with a time of 20 minutes. The child in the film was cooperative and was reinforced by a reward at the end of the procedure.
16133565|NCT01908127|Drug|injection of local anesthesia solution|A topical anesthesia and injection of local anesthesia solution using mandibular alveolar nerve block technique was performed by the dentist
16133566|NCT01908127|Procedure|occlusal cavity preparation|the occlusal cavity was prepared for pulpotomy and restoration of the teeth
16133567|NCT01908114|Behavioral|Enhanced Community mobilization|
16133568|NCT01908114|Biological|Combined Oral Polio Vaccine and Inject able Polio Vaccine during SIA|
16133569|NCT01908101|Drug|Eribulin Mesylate|Given IV
16133570|NCT01908101|Other|Laboratory Biomarker Analysis|Correlative studies
16133571|NCT01908088|Biological|Cell transplantation|autologous transplantation of cultured fibroblast on amniotic membrane in patients with Epidermolysis Bullosa with mitten hands.
16133572|NCT01908075|Drug|FP/SAL|
16133573|NCT01908075|Drug|BDP/FOR|
16133574|NCT01908062|Drug|Extended Release Naltrexone|
16133575|NCT01908062|Other|Treatment As usual|
16133576|NCT01908049|Dietary Supplement|Probiotic.|
16133577|NCT01908049|Dietary Supplement|Placebo|
16133578|NCT01908023|Behavioral|exercise|One hour, twice a week, for 5 weeks: warming-up with aerobic exercises, endurance exercises, strength exercises for large muscle groups, body awareness, range-of- motion exercises for the shoulders and stretching and relaxation
16133579|NCT01908010|Drug|ABT-354|ABT-354 Low Dose
16133580|NCT01908010|Drug|ABT-354|ABT-354 High Dose
16133581|NCT01908010|Drug|Placebo|Placebo
16133582|NCT01907997|Drug|Systemic intravenous lidocaine infusion|In group L, intravenous lidocaine infusion(0.1mg/kg) for 10minutes after induction of anesthesia. After 10 minutes, lidocaine infusion continued at rate of 3mg/kg/hr during operation, and discontinued before move the patients to PACU.
16133583|NCT01907997|Drug|normal saline infusion|In group C, the patients receive same volume of normal saline
16133584|NCT01907984|Drug|Diclofenac|
16133585|NCT01907984|Drug|Midazolam|
16133586|NCT01907945|Behavioral|Microclinic Water Program|Three session educational program is delivered to study participants and their self-selected social networks in a group setting. The three session topics are the spread of water borne illness, water treatment methods and social support for sustaining household water treatment. Sessions are taught by a trained community health worker and a study staff member.
16133587|NCT01907945|Behavioral|Household education|Three session educational program is delivered to study participants at an individual household level. The three session topics are the spread of water borne illness, water treatment methods and social support for sustaining household water treatment. Sessions are taught by a trained community health worker and a study staff member.
16133588|NCT01907932|Device|VScan Ultrasound (GE Healthcare, USA)|VScan Ultrasound used to determine spleen size and the other qualities described in the arm description.
16133589|NCT01907906|Device|Mirasol System for Whole Blood|LR-pRBC units derived from WB will be treated with the Mirasol System. Treatment with the Mirasol System requires riboflavin to be mixed into the whole blood unit, which is then exposed to ultra violet (UV) light for a period of time; approximately an hour.
16133590|NCT01907893|Behavioral|Trauma Collaborative Care Plus Treatment as Usual|
16133591|NCT01907880|Drug|Pamidronate|90mg IV once every 4 weeks for 3 cycles
16133592|NCT01907880|Drug|Zoledronic acid|4mg IV every 4 weeks for 3 cycles
16133593|NCT01907880|Drug|placebo|
16133594|NCT01907867|Drug|Finafloxacin 800 mg (as 4 x 200 mg tablet) once daily for 3 days|
16133595|NCT01907854|Drug|liraglutide|Starting dose of 0.6 mg/day, with weekly dose escalations of 0.6 mg/day until the maintenance dose of 1.8 mg/day is reached. Administered subcutaneously (s.c., under the skin) once daily + metformin tablets (at least 1000 mg/day)
16134172|NCT01903330|Drug|GM-CSF|Given intradermally
16133596|NCT01907854|Drug|sitagliptin|100 mg/day sitagliptin tablets once-daily + metformin (at least 1000 mg/day)
16133597|NCT01907854|Drug|placebo|Sitagliptin placebo tablets once-daily
16133598|NCT01907854|Drug|placebo|Sitagliptin placebo tablets once-daily
16133599|NCT01907841|Other|Ischemic Preconditioning|
16133600|NCT01907828|Device|Renal Artery Ablation|Renal artery denervation using the EnligHTN™ Renal Denervation System
16133601|NCT01907828|Device|Cardiac Ablation|Safire BLU™ Duo or Therapy Cool Path Duo Irrigated Ablation Catheter or Therapy Cool Flex Irrigated Ablation Catheter EnSite Velocity System Agilis NxT Guiding Introducer
16133602|NCT01907815|Drug|Akt Inhibitor GSK2141795|Given PO
16133603|NCT01907815|Other|Laboratory Biomarker Analysis|Correlative studies
16133604|NCT01907815|Drug|Trametinib|Given PO
16133605|NCT01907802|Drug|Dabrafenib|Given PO
16133606|NCT01907802|Other|Laboratory Biomarker Analysis|Correlative studies
16133607|NCT01907802|Other|Pharmacogenomic Study|Correlative studies
16133608|NCT01907802|Other|Pharmacological Study|Correlative studies
16133609|NCT01907789|Other|Ovarian Cancer Screening|Woman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer will return to clinic every six months to undergo screening for ovarian cancer symptoms, physical examination, CA125, HE4, and transvaginal ultrasound.
16133610|NCT01907789|Procedure|Prophylactic Salpingectomy with Delayed Oophorectomy|Woman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer have salpingectomy performed as an outpatient procedure. After the 3-year follow up period, oophorectomy performed as an outpatient procedure.
16133611|NCT01907789|Procedure|Risk-Reducing Salpingo-Oophorectomy|Woman who have a mutation (genetic change) in one of the BRCA genes, and are at high risk for developing ovarian cancer have risk-reducing salpingo-oophorectomy (RRSO) performed as an outpatient procedure.
16133612|NCT01907789|Behavioral|Questionnaire|"Ovarian Screening Group: Quality of life (QOL) questionnaire completed at baseline, end of year 1, 2, and 3.
~Prophylactic Salpingectomy with Delayed Oophorectomy (PSDO): Quality of life (QOL) questionnaire completed at baseline, 1 month 1 year, 2 years, and 3 years after salpingectomy. Also before oophorectomy performed, 1 month and 6 months after oophorectomy.
~Risk-Reducing Salpingo-Oophorectomy (RRSO) Group: Quality of life (QOL) questionnaire completed at baseline, then 1 month, 6 months, and 1 year after surgery."
16133613|NCT01907789|Procedure|Transvaginal Ultrasound|"Ovarian Cancer Screening Group: Transvaginal ultrasound performed at baseline and every 6 months for 3 years.
~Prophylactic Salpingectomy with Delayed Oophorectomy (PSDO) group: Transvaginal ultrasound performed at baseline, every 6 months for 3 years after salpingectomy, then before oophorectomy.
~Risk-Reducing Salpingo-Oophorectomy (RRSO) Group: Transvaginal ultrasound performed at baseline."
16133614|NCT01907789|Behavioral|Phone Call|"Ovarian Cancer Screening Group and Prophylactic Salpingectomy with Delayed Oophorectomy (PSDO) Group: Phone call made to patient one time a year after third year follow up.
~Risk-Reducing Salpingo-Oophorectomy (RRSO) Group: Phone call made to patient 1 day after surgery, 1 week after surgery, then yearly."
16133615|NCT01907776|Drug|ME1100 inhalation solution|ME1100 inhalation solution (arbekacin for oral inhalation at 150mg/mL), 0.6, 2.0, 3.0, 4.0, 6.0, or 9.0mL, Single Dose
16133616|NCT01907776|Drug|ME1100 placebo inhalation solution|Vehicle placebo
16133617|NCT01907763|Drug|SOTB07 200mg|
16133618|NCT01907763|Drug|SOTB07 400mg|
16133619|NCT01907763|Drug|SOTB 200mg placebo|Placebo of SOTB07 200mg
16133620|NCT01907763|Drug|SOTB 400mg placebo|Placebo of SOTB07 400mg
16133621|NCT01907750|Device|biliary drainage tube|
16133622|NCT01907737|Other|Active tDCS|Active tDCS will be applied with the anode positioned over the ipsilesional M1 and the cathode over the contralateral supraorbital region for 20 minutes (1mA).
16133623|NCT01907737|Other|Active PNS|Active PNS will be administered by 2 pairs of surface electrodes (cathode proximal). One pair will overly the median and ulnar nerves at the wrist, and the other pair will overly the radial nerve. Trains of electric stimulation will be delivered at 1 Hz by using isolation units connected to a square pulse stimulator.
16133624|NCT01907737|Other|Sham tDCS|In sham tDCS, no current will be delivered through the tDCS device.
16133625|NCT01907737|Other|Sham PNS|No current will be delivered to the radial, ulnar and median nerves.
16133626|NCT01907724|Drug|IDX719|IDX719 will be supplied as a 50 mg tablet for oral administration.
16133627|NCT01907724|Drug|Simeprevir|Simeprevir will be supplied as 75 mg capsules for oral administration.
16133628|NCT01907724|Drug|TMC647055|TMC647055 will be supplied as 150 mg capsules for oral administration.
16133629|NCT01907724|Drug|RTV|RTV will be supplied as 80 mg/mL solution for oral administration.
16133630|NCT01907711|Device|Acupuncture.|"Who tried the insertion and manipulation between 8 - 12 needles with guide applied at different points of the body, individually selected and customized, after the insertion, the acupoint stimulation is done through manipulation of de needle sleeve to achieve at each point the sensation known as De Qi."
16133631|NCT01907698|Behavioral|Vaginal intercourse|vaginal intercourse at least twice a week
16133632|NCT01907685|Drug|AVE8062|"Pharmaceutical form:Solution for infusion
~Route of administration: Intravenous"
16133633|NCT01907685|Drug|Docetaxel|"Pharmaceutical form: solution for infusion
~Route of administration: Intravenous"
16133634|NCT01907672|Procedure|Rapid Diagnostic Test|Rapid Diagnostic Test for Malaria carried out to direct antimalarial dispensing. No antimalarials for negative tests, antimalarials for positive tests
16133635|NCT01907659|Other|Release of test results|Subjects will be randomized to have viral testing and serum PCT results released or no additional testing performed other than that ordered as standard of care
16133636|NCT01907646|Device|bladder training|vescical catheter
16133637|NCT01907646|Procedure|No bladder training|
16133638|NCT01907633|Drug|No intervention|This is an observational and a retrospective study of existing data, so there will be no interventions. The exposure groups will be domperidone, proton pump inhibitors (omeprazole, lansoprazole, esomeprazole, rabeprazole, and pantoprazole), and metoclopramide.
16133639|NCT01907620|Other|blood sample|
16133678|NCT01907282|Behavioral|Family Focused Treatment|Treatment for family that focuses on skills for coping with subthreshold positive and negative symptoms and improving family communication and problem-solving
16133640|NCT01907607|Drug|PD 0332991|"PD-0332991 was administrated orally, formulated as gelatin capsules of 100 mg and 25 mg respectively.
~PD-0332991 was dosed on a flat scale of 125 mg (1 capsule x 100 mg/day, 1 capsule x25 mg/day) will be administrated orally o.d on a 21 days on / 7 days off dosing schedule. One cycle is considered to consist of 4 weeks of PD-0332991 administration.
~Patients should be instructed to administrate PD-0332991 with a sufficient amount of water at least 1 hour prior to a meal or at least 2 hours following a meal and to swallow the required number of capsules at approximately the same time on each day."
16133641|NCT01907594|Drug|D-cycloserine|
16133642|NCT01907594|Drug|Nicotine Replacement Therapy (patch)|
16133643|NCT01907594|Behavioral|Smoking Cue Exposure|
16133644|NCT01907594|Behavioral|Progressive Muscle Relaxation|
16133645|NCT01907594|Drug|Placebo|The investigators will administer Gelatin Capsule instead of D-Cycloserine in a double blind fashion to some of study subjects.
16133646|NCT01907581|Other|Quality of life questionnaires|
16133647|NCT01907542|Procedure|stapled skin closure|as above
16133648|NCT01907542|Procedure|monocryl skin suture|as above
16133649|NCT01907529|Drug|docetaxel, epirubicin and cyclophosphamide|docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, cyclophosphamide 500mg/m2, IV (in the vein) on day 1 of each 21 day cycle; totally 4 cycles
16133650|NCT01907529|Drug|docetaxel, epirubicin and cyclophosphamide plus endostar|docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, cyclophosphamide 500mg/m2, IV (in the vein) on day 1 of each 21 day cycle; endostar 7.5mg/m2, IV (in the vein) from day 1 to day 14, totally 4 cycles
16133651|NCT01907516|Device|Cell phone-internet home glucose reporting system|Glucose monitoring via cell phone and internet using the Confidant Diabetes Management Application and the Confidant Connector.
16133652|NCT01907516|Behavioral|Voicemail home blood glucose reporting|Glucose monitoring via standard telephone and fax reporting.
16133653|NCT01907503|Procedure|Evaluation of the balance of force platform|
16133654|NCT01907490|Drug|Ha44 Gel|Eligible subjects will be treated at the study site on Day 0 with a single application of the maximum feasible amount of Ha44 Gel, to ensure saturation of the scalp and hair.
16133655|NCT01907477|Other|Samples taken at the clinical hematology unit|
16133656|NCT01907464|Other|clinical parameters description|description of weight, height, Bone Mass Index, dietary questionnary, amenorrhea time, pathology time for the two arms
16133657|NCT01907464|Other|para clinical parameters description|description of DMO, mass, basal metabolism, IGF-1/IGFBP-3 for the two arms
16133658|NCT01907464|Other|hormonal parameters dosing|dosing of leptine, leptine receptor, adiponectine, ghreline for the two arms
16133659|NCT01907464|Other|bone modeling markers dosing|dosing of osteocalcine, bone alkalin phosphatase, C-telopeptide of type-I collagene, osteoprotegerine/ RANKL for the two arms
16133660|NCT01907425|Other|Blood samples|
16133661|NCT01907412|Behavioral|Family Foundations Coparenting Program|"Family Foundations, a program for adult couples expecting their first child, is designed to help them establish positive parenting skills and adjust to the physical, social, and emotional challenges of parenthood. Program topics include coping with postpartum depression and stress, creating a caring environment, and developing the child's social and emotional competence.
~Family Foundations is delivered to groups of couples through four prenatal and four postnatal classes of 2 hours each. Prenatal classes are started during the fifth or sixth month of pregnancy, and the postnatal classes end when the children are 6 months old.
~Family Foundations is delivered in a community setting by childbirth educators who have received 3 days of training from Family Foundations staff."
16133662|NCT01907399|Other|Blood samples|
16133663|NCT01907386|Other|QSE-LSME - SSWI Ultrasound|Doppler ultrasound (DUS) and elastographic examinations will be performed using a single probe (6-1 MHz, Super Curved, Vermon, Tours, France) with the clinical Aixplorer system (Supersonic Imagine, Aix-en-Provence, France), a new generation ultrasound scanner providing an outstanding B-mode and color-Doppler image quality, allowing exportation of RF images for QSE-LSME acquisition and integrating the shear wave elastography (SSWI) mode.
16133664|NCT01907373|Drug|olmesartan medoxomil|
16133665|NCT01907373|Drug|olmesartan medoxomil+probenecid|
16133667|NCT01907334|Drug|Advair Diskus100/50 µg|Advair Diskus 100/50 µg
16133668|NCT01907334|Drug|Flovent Diskus 100 µg|Flovent Diskus 100 µg
16133669|NCT01907334|Drug|Methacholine Chloride|Methacholine Chloride in quadrupling concentrations from 0.25 to 64 mg/mL will be given based upon subject's baseline response.
16133670|NCT01907334|Drug|Albuterol|Albuterol will be administered at the end of each methacholine challenge.
16133671|NCT01907321|Behavioral|Expiratory muscle strength training|Small hand held device that provides calibrated (cmH20) resistance to expiratory pressure. Once sufficient pressure is achieved (participant blowing out into the device) a valve is released, letting air flow through.
16133672|NCT01907321|Behavioral|Placebo expiratory training|Device with the same look and feel as the active EMST, but which provides no resistance to airflow.
16133673|NCT01907321|Drug|Measures performed on all subjects|Capsaicin is a cough-inducing vapor that will be inhaled by participants to induce coughing. The airflow of the cough will be recorded and measures of compression phase duration, peak expiratory flow rate, and post-peak plateau phase will be made.
16133674|NCT01907321|Behavioral|Pulmonary function test|Measures of forced vital capacity (FVC) and Forced expiratory volume in the 1st second (FEV1), and the ratio between the two measures (FEV1/FVC). Also included is the measure of maximum expiratory pressure. Airflow from the voluntary cough will also be recorded and measured using the spirometric system. These measures will be identical to those made on the capsaicin-induced cough.
16133675|NCT01907321|Radiation|Fluoroscopic swallow study|Images from the swallow study will be used to determine the modified barium swallow impairment profile (MBSImp) score, as well as the penetration-aspiration score (PA).
16133676|NCT01907308|Drug|AMG 386|Patients will receive AMG 386 30mg/kg IV weekly plus docetaxel 75mg/m2 IV every 3 weeks.
16133677|NCT01907308|Drug|Docetaxel|Patients will receive AMG 386 30mg/kg IV weekly plus docetaxel 75mg/m2 IV every 3 weeks.
16133712|NCT01907100|Drug|Placebo|Nintedanib matching placebo
16134300|NCT01902251|Drug|Enzalutamide tablet|Oral
16133679|NCT01907282|Behavioral|Enhanced Care|This 3-session psychoeducational treatment assists individuals and families in coping with early warning signs of psychotic episodes.
16133680|NCT01907269|Behavioral|Video-based Intervention|Video clips delivered by DVD and Internet
16133681|NCT01907256|Procedure|inverted V incision|It is a type of incision
16133682|NCT01907256|Procedure|stair step incisions|It is a type of incision
16133683|NCT01907243|Procedure|spreader flap|producing of upper lateral cartilage flap as a spreader flap
16133684|NCT01907230|Drug|Entecavir|In the prophylactic group, participants will initiate entecavir 0.5 mg/day orally one week before biologic treatment. Entecavir treatment (adjust dosage according to renal function) will be continued normally for 12 months (6 months after stopping biologic therapy or till restart another course of biologic treatment if the clinicians' judgment is minimal risk of reactivation after the first course of biologic agent treatment).
16133685|NCT01907217|Device|ECT Mecta 5000M|ECT is administered twice weekly with hand-held electrodes using the Mecta 5000M device following a standard stimulus dosing protocol. Seizure duration is measured by EEG monitoring. Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia with suxamethonium (0.5-1.0 mg/kg) as muscle relaxant. Seizure threshold (ST) is established by a method of limits at the first session and subsequent treatments will be given at 1.5 x ST for BT ECT and 6.0 x ST for RUL ECT. To reflect routine clinical practice, number of ECT treatments is determined by referring physicians who will be blind to randomisation. The treatment period varies between patients to allow up to 12 administrations of ECT, i.e. up to 6 weeks.
16133686|NCT01907217|Drug|Methohexitone|Methohexitone (0.75-1.0 mg/kg) is used for anaesthesia along with suxamethonium (0.5-1.0 mg/kg)for muscle relaxation. Anesthesia is the same for both arms of the trial.
16133687|NCT01907217|Drug|Suxamethonium|Suxamethonium (0.5-1.0 mg/kg)is used for muscle relaxation along with Methohexitone (0.75-1.0 mg/kg) for anaesthesia. Anesthesia is the same for both arms of the trial.
16133688|NCT01907204|Drug|methylprednisolone|Oral 32mg/8d-16mg/4d-8mg/4d
16133689|NCT01907204|Drug|Budesonide|Budesonide by metered dose inhaler
16133690|NCT01907204|Drug|Budesonide|Budesonide by nebulization
16133691|NCT01907191|Drug|liposomal bupivacaine|(Ultrasound guided injection of liposomal bupivacaine)
16133692|NCT01907191|Drug|Bupivacaine|(around the anterior, lateral and medial aspect of hip joint)
16133693|NCT01907165|Drug|Temozolomide|
16133694|NCT01907165|Drug|Disulfiram|
16133695|NCT01907165|Dietary Supplement|Copper gluconate|
16133696|NCT01907152|Other|Protein enriched yoghurt drink and bread|
16133697|NCT01907139|Behavioral|Robot-assisted therapy|Instrumentation of the ArmeoSpring with position sensors at each joint enables it to be used as a 3D input device for computer game play with the hemiparetic arm. Games were designed to simulate functional arm movements to provide training in a simple virtual reality environment. Vu Therapy games were developed with the goal of enabling repetitive task-specific practice including grocery shopping, cleaning a stovetop, and playing basketball. In this way, stroke patients who are unable to use their severely weakened arms in a functional way are able to practice task-specific movements in a simulated, gravity-reduced environment. Auditory and visual feedback is provided throughout game play to maintain the patient's attention and motivation. In addition, users are provided objective feedback of task performance at the end of each game to enhance motivation and awareness of progress.
16133698|NCT01907139|Behavioral|Distributed constraint-induced therapy|The dCIT group will focus on restriction on movement of the unaffected hand by placement of the hand in a mitt for 6 hours/day and intensive training of the affected UL in functional tasks for 1.5 hours/weekday over the 4 weeks. Participants in this group will focus on the intensive training of the affected arm in functional activities with behavioral shaping. The shaping techniques will involve individualized task selection, graded task difficulty (e.g., practicing deficient parts of the selected activity and then performing the entire activity), verbal feedback, prompting, physical assistance with movements, and modeling. The level of challenge will be adapted based on patient ability and improvement. Participants will be also required to place their unaffected hand and wrist in a mitt for 6 hours a day during the 4-week period and document mitt compliance in daily logs.
16133699|NCT01907139|Behavioral|Dose-matched control therapy|The DMCT group mediated by the therapists will be designed to control for the duration of therapy in amount of therapy hours. This group will received a structured protocol using conventional occupational therapy techniques such as neuro-developmental techniques with emphasis on functional tasks and muscle strengthening. The treatment protocol will include (1) passive range of motion exercises, stretching of the affected limb, or facilitatory and inhibitory techniques for 15 to 20 minutes, (2) tasks for training fine motor or dexterous function for 20 minutes, (3) arm exercises or gross motor training for 20 minutes, (4) muscle strengthening of the affected UL for 15 to 20 minutes, and (5) activities of daily living or functional tasks practice for 15 to 20 minutes. The activities will be adapted based on the level of motor impairment and individual needs of the patients.
16133700|NCT01907126|Behavioral|Nutrition Program (NP)|Nutrition Program (NP) participants will receive the same number, format, and schedule of group and individual 60-minute sessions, which will focus on low-cost strategies for improving nutrition.
16133701|NCT01907126|Behavioral|Women's Prison CoOp (WPC)|Weekly as 60-minute sessions, 3 group and two individual sessions during incarceration as close to prison discharge as possible. Session 1 focuses on understanding and reviewing HIV risks, including interpersonal violence. Session 2 addresses gender, power, violence, and affect management to counter the emotional effects of violence. Session 3 addresses IV-specific sexual safety skills, including affect management skills. Session 4 helps women begin to develop a personalized safety plan, which may include increasing social support and access to resources. Session 5 helps her finalize and practice the plan, and Session 6 problem-solves any difficulties that have arisen in executing the plan.
16133702|NCT01907113|Drug|BI 10773|oral administration
16133703|NCT01907113|Drug|BI 10773|oral administration
16133704|NCT01907113|Drug|BI 10773|oral administration
16133705|NCT01907113|Drug|BI 10773|oral administration
16133706|NCT01907113|Drug|BI 10773|oral administration
16133707|NCT01907100|Drug|Nintedanib|triple kinase inhibitor; 200mg starting dose
16133708|NCT01907100|Drug|Pemetrexed|backbone chemo
16133709|NCT01907100|Drug|Cisplatin|backbone chemo
16133710|NCT01907100|Drug|Cisplatin|backbone chemo
16133711|NCT01907100|Drug|Pemetrexed|backbone chemo
16133713|NCT01907087|Biological|BMN 190|30-300 mg ICV infusion administered every other week for at least 48 weeks.
16133714|NCT01907074|Drug|Cholates|Cholates is given intravenously (IV push) and by mouth, once per study visit
16133715|NCT01907061|Drug|N-acetylcysteine|drug will be administered via IV,NG
16133716|NCT01907061|Drug|Placebo|placebo or NAC will be given
16133717|NCT01907048|Behavioral|Rivaroxaban (Xarelto, BAY59-7939)|Survey to measure physician awareness and understanding of the key messages in the prescriber guide.
16133718|NCT01907048|Behavioral|Rivaroxaban (Xarelto, BAY59-7939)|Survey to measure patient awareness and understanding of the key messages in the patient card.
16133719|NCT01907035|Behavioral|A cognitive-behavioral intervention|Evaluate the effectiveness of a cognitive-behavioral intervention by psychologists in collaboration with MF plus routine therapy in the field of APS in anxiety-depressive patients mild to moderate, with respect to standardized usual care by physicians, improve quality of life of these people, producing at least ten-point increase in the level of overall quality of life (SF-36)
16133720|NCT01907035|Other|Usual care|
16133721|NCT01907022|Device|Left DLPFC Butterfly Coil|"High frequency rTMS ( Alpine Biomed Mag Pro Option): 2000 stimuli of 20 Hz over the left DLPFC (each session), Butterfly-water-cooled-Coil, 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold. Relaxation therapy during the 1Hz stimulation with external audio tape instructions.
~Arms: Left DLPFC Butterfly Coil"
16133722|NCT01907009|Drug|Melphalan|Patients will receive Melphalan in three cycles In the first cycle they recieve 60mg/m2 and then 40mg/m2 in the next two cycles.
16133723|NCT01907009|Drug|Lenograstim|"Starting Lenograstim will be at 10mcg/kg/day and between cycles at 10mcg/kgs/day.
~After the third cycle patient will receive 263mcg/day for 10 days."
16133724|NCT01906996|Procedure|proximal row carpectomy|excision of the scaphoid, lunate and triquetrum
16133725|NCT01906996|Procedure|four corner fusion|excision of the scaphoid and stiffening of the lunate, capitate and triquetrum by a plate
16133726|NCT01906983|Other|Doppler Ultrasound|Doppler ultrasound will be performed to patients with blunt splenic trauma, prior to discharge and again, at 3-6 months in patients with thrombosis indication.
16133727|NCT01906970|Device|ClampArt|
16133728|NCT01906957|Other|high intensity interval training (HIIT)|High-intensity interval exercise (HIIE) session This HIIE session will be based on a previous study conducted in our laboratory that compared physiological, psychological and electrocardiological tolerance of four different single bouts of HIIE in coronary patients (Guiraud et al. 2010). The selected HIIE session represented the best compromise between safety, time spent at a high level of VO2peak and psychological adherence. This HIIE session consists of a 10-min warm-up at 50% of MAP, followed by two sets of 10 min composed of repeated bouts of 15 s at 100% of MAP interspersed by 15 s of passive recovery. Four minutes of passive recovery were allowed between the two sets, as well as a 5-min cool-down after the last 15-s exercise bout. A total duration of 35 minutes will be employed for this session for coronary artery disease patients, and 22 minutes for chronic heart failure patients (Guiraut et al. 2010 b).
16133729|NCT01906957|Other|moderate intensity continuous exercise training|Moderate Intensity Continuous Exercise (MICE) session This exercise session will be based on the recommendations of the American Heart Association on exercise prescription in cardiac rehabilitation (Balady et al. 2007), suggesting that exercise intensity should lie between 50% and 80% of maximal aerobic power (MAP). We opted for an intensity of 70% of MAP. Duration will be adjusted to match total energy expenditure of the HIIE, according to the previous methodology method (Guiraud et al. 2010 b). A total duration of 28.7 minutes will be employed in healthy elderly patients, coronary artery disease patients and patients with metabolic syndrom; and 16 minutes in chronic heart failure patients.
16133730|NCT01906944|Drug|Bupivacaine 0.25%|Bupivacaine is a local anaesthetic drug belonging to the amino amide group.
16133731|NCT01906944|Drug|Triamcinolone|Triamcinolone is a long-acting synthetic corticosteroid.
16133732|NCT01906931|Device|Portable oxygen concentrator|Respironics EverGo portable oxygen concentrator on setting 6
16133733|NCT01906931|Device|Portable oxygen cylinder|Portable oxygen cylinder at flow rate 5 Litres/min
16133734|NCT01906918|Procedure|IRPC, Remote preconditioning|The patients will be submitted to 5 minutes of upper limb compression by cuff followed by 5 minutes of reperfusion. This cycle will be repeated 4 times.
16133735|NCT01906905|Device|Transcranial Magnetic Stimulation|
16133736|NCT01906892|Other|Group drumming (participatory)|Active participation in group drumming workshops
16133737|NCT01906892|Other|Group drumming (live)|Listening to live performances of group drumming
16133738|NCT01906892|Other|Group drumming (recorded)|Listening to recorded performances of group drumming
16133739|NCT01906892|Other|Comparative activity|Taking part in a literary-based activity
16133740|NCT01906879|Drug|triple, quadruple, non-bismuth quadruple therapy|triple therapy, quadruple therapy, non-bismuth quadruple therapy
16133741|NCT01906866|Drug|Circadin 2/5/10 mg|Active arm
16133742|NCT01906866|Drug|Placebo|
16133743|NCT01906853|Biological|BCG|
16133744|NCT01906840|Drug|Turmeric|
16133745|NCT01906840|Drug|placebo|
16133746|NCT01906814|Drug|3 cycles chemotherapy|Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first three months.
16133747|NCT01906814|Drug|6 cycles chemotherapy|Chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.monthly for the first six months.
16133748|NCT01906801|Drug|Glucosamine sulfate|
16133749|NCT01906801|Drug|Diacerein|
16133750|NCT01906801|Drug|Placebo (for Diacerein)|Sugar pill manufactured to mimic Diacerein 50 mg tablet
16133751|NCT01906788|Drug|Artemether Lumefantrine|
16133752|NCT01906788|Drug|Artemether Lumefantrine 6 dose regimen & single dose of Primaquine on day 0|
16133753|NCT01906788|Drug|Artemether Lumefantrine 6 dose regimen and single dose Primaquine on day 2|
16133754|NCT01906775|Other|Programming the pacemaker output for ventricular back-up pacing to a sub-threshold level|Programming the pacemaker output for ventricular back-up pacing to a sub-threshold level to achieve an ineffective pacing output
16133832|NCT01906008|Drug|Placebo|1 placebo by mouth for the first day of chemotherapy, then 1 dose every 12 hours for 4 months beginning at chemotherapy initiation.
16133755|NCT01906762|Drug|Acetaminophen|This protocol prepared by a nurse and labeled as Drug A. Since the rapid injection of Acetaminophen can result in hypotension, therefore based on the Apotel Injection Instruction, it must be infused slowly within 15 minutes.
16133756|NCT01906762|Drug|Morphine|This protocol was prepared by a nurse and labeled as Drug B. Since the rapid injection of Morphine can result in histamine release, therefore it must be infused slowly within 15 minutes. The nurse, who was in charge of infusing pain reliever, was unaware of the type of injected drug.
16133757|NCT01906749|Drug|Colchicine|0.5mg once daily orally
16133758|NCT01906749|Drug|Placebo|
16133759|NCT01906723|Device|Walker|The Up n' Free (Easy Walking) is a gait trainer equipped with a dynamic partial weight-bearing. The trainer is designed to provide the user with independence, safety, and endurance. It allows for easy transfer from sitting to standing position and stabilizes the pelvis, allowing for free movement of the hands.
16133760|NCT01906710|Other|integrated medicines management|"PITH includes the following interventions:
~A) MR on admission to obtain an up-to-date medication list, B) Intermediate medication review during hospitalization C) MR at discharge to maintain an up-to-date medication overview, counseling of the patient at hospital discharge and preparation of the patient to manage their medication at home., Written material is provided for oral support, which includes an overview of the current medication, a summary of potentially important side effects, advices on medication use and hospital pharmacy contact information in order to answer any possible questions, D) Information transfer to GP/community pharmacist at discharge"
16133761|NCT01906697|Procedure|middle turbinate Radio Frequency (RF) turbinoplasty|middle turbinate Radio Frequency (RF) turbinoplasty
16133762|NCT01906697|Procedure|middle turbinate resection|middle turbinate resection
16133763|NCT01906697|Procedure|middle turbinate medialization|middle turbinate medialization
16133764|NCT01906684|Drug|Acthar Gel|Patients who present with MS relapse within 72 hours of onset will be recruited for study. Upon consent they will be administered Achtar Gel for 5-14 days as clinically appropriate.
16133765|NCT01906671|Drug|Xaluprine|Comparison of plasma kinetics after administration of 6-mercaptopurine in the form of a tablet (Puri-Nethol) and in the form of an oral liquid formulation (Xaluprine). Each patient will be included in both arms of the study, because of the cross-over design.
16133766|NCT01906671|Drug|Puri-Nethol|Comparison of plasma kinetics after administration of 6-mercaptopurine in the form of a tablet (Puri-Nethol) and in the form of an oral liquid formulation (Xaluprine). Each patient will be included in both arms of the study, because of the cross-over design.
16133767|NCT01906658|Drug|Repository corticotropin injection|Acthar given SC twice weekly (80 U or 56 U) or daily (24 U or 16 U) for 8 weeks
16133768|NCT01906645|Other|Care Transitions Innovation (C-TraIn)|Multi-component transitional care intervention including transitional nursing care, pharmacy care, and medical home linkages
16133769|NCT01906632|Biological|DC-CIK Immunotherapy|
16133770|NCT01906606|Behavioral|Parenting Program|A manualized, community-based 12 session group parenting program, facilitated by a locally recruited volunteer
16133771|NCT01906580|Drug|Peg-IFNα-2a|180ug peg-IFNα-2a, subcutaneous injection per week
16133772|NCT01906580|Drug|Entecavir|0.5mg,oral administration every day
16133773|NCT01906554|Other|Egg Dose|Different quantities of eggs
16133774|NCT01906541|Genetic|ex-vivo gene-therapy|transplantation autologous CD34+ cells, transduced with a SIN gammaretroviral vector
16133775|NCT01906528|Drug|Mivacurium|Effect of Mivacurium in males vs females
16133776|NCT01906515|Device|Continuous non-invasive hemoglobin monitoring|Anesthesiologist is provided with real-time continuous non-invasive hemoglobin monitoring to influence care provided to patient
16133777|NCT01906502|Device|Sensimed Triggerfish|
16133778|NCT01906489|Drug|AKB-6548|Oral dose administered once daily for 20 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
16133779|NCT01906489|Drug|Placebo|Oral placebo administered once daily for 20 weeks. Dose adjustment based on hemoglobin level as defined in the protocol.
16133780|NCT01906476|Behavioral|Stepped Care|Participants will receive an Internet guided cognitive behavioral treatment (iCBT) with support from a telephone coach with the possibility of being stepped up to receiving telephone cognitive behavior therapy (T-CBT) with a therapist
16133781|NCT01906476|Behavioral|Telephone Cognitive Behavior Therapy|Participants will receive telephone-administered cognitive behavioral therapy (T-CBT).
16133782|NCT01906450|Drug|Scaling and root planing plus Azithromycin|Single session of scaling and root planning using ultrasonic device. Azithromycin tablets 500mg, 1 tablet every 24 hours for 5 days
16133783|NCT01906450|Drug|Scaling and root planing plus placebo|Single session of scaling and root planning placebo tablets 500mg, 1 tablet every 24 hours for 3 days
16133784|NCT01906437|Device|Cardiac Magnetic Resonance Scan|Cardiac Magnetic Resonance Scan
16133785|NCT01906424|Device|Transcutaneous Electrical Spinal Cord Stimulation|A prototype device that delivers transcutaneous electrical stimulation will be used to stimulate the cervical spinal cord.
16133786|NCT01906411|Dietary Supplement|Dopamine depletion vs. Balanced aminoacid drink|
16133787|NCT01906398|Other|ketogenic diet|KD will consist of 3:1 [fat]: [protein + carbohydrate] weight ratio, with 1600 kcal restriction
16133788|NCT01906385|Drug|Rhenium Liposome Treatment|At the time of stereotactic biopsy a catheter will be placed within the tumor using stereotactic guidance. Once the patient has adequately recovered from the procedure as determined by the neurosurgeon, 186RNL will be infused through the catheter at the predetermined dose. Spectroscopic imaging will then be obtained at predefined time points to visualize the distribution of the 186RNL as well as calculated the actual dose retained within the tumor. Patients will be monitored longitudinally for evidence of toxicity and response by MRI.
16133789|NCT01906372|Drug|Adrenocorticotropic Hormone Gel|H.P. Acthar Gel 80 units will be self-administered subcutaneously twice weekly by the subject for a period of 6 months.
16133790|NCT01906359|Other|Native palm olein (IV56)|Test meal consists of a high fat muffin (containing 50 g native palm olein) and a cup of milkshake, to be taken as breakfast for each postprandial study day.
16133791|NCT01906359|Other|Chemically interesterified palm olein (IV56)|Test meal consists of a high fat muffin (containing 50 g chemically interesterified palm olein) and a cup of milkshake, to be taken as breakfast for each postprandial study day.
16133907|NCT01905345|Procedure|Training|
16133792|NCT01906359|Other|High oleic sunflower oil|Test meal consists of a high fat muffin (containing 50 g high oleic sunflower oil) and a cup of milkshake, to be taken as breakfast for each postprandial study day.
16133793|NCT01906346|Drug|Cocaine|Three active doses of cocaine will be made available for self-administration during experimental sessions.
16133794|NCT01906346|Drug|Placebo|Placebo cocaine will be made available for self-administration during experimental sessions.
16133795|NCT01906333|Other|Exercise|
16133796|NCT01906333|Other|Glucose|
16133797|NCT01906333|Other|Fasted|
16133798|NCT01906320|Behavioral|High-Intensity Resistance training|"Intervention group performed 3 weekly sessions during 8 weeks in the intra-hospital gymnasium. Each session lasted 50-60 min, and started and ended with warm-up and cool-down periods (10-15 min).
~The core session included bench press, leg press, lateral row, leg extension, lateral pull-down, abdominal crunch, low back extension, and push-ups exercises. The participants performed three sets of 8-10 repetitions with resting periods of 1-2 min on the weightlifting machines. Load was gradually increased 5-10 % as the participant strength was adapted. The load started at 70% of 6RM.
~Functional exercises (abdominal crunch, low back extension, and push-ups) were performed at the end of the session to strengthen the core musculature consisting of 3 sets of 15s of isometric contractions at the beginning of the program and 30 s at the end. Dynamic contractions were added, starting with 10 repetitions at the beginning to 30 repetitions at the end of the program."
16133799|NCT01906307|Drug|LJPC-501|Patients will receive LJPC-501 at titrated doses, with a starting range from 1 to 100 ng/kg/min, by continuous infusion on Days 1 through 5. In Group 1, drug doses will be titrated to 5, 15, and 25 ng/kg/min, after which doses will be titrated in multiples of 25 ng/kg/min. In Groups 2-5, drug doses will be titrated by 25 ng/kg/min. Dose titrations will occur every 2 hours until a MAP of 110 mmHg is reached, maximum urine output is achieved, or a dose of 250 ng/kg/min is achieved. Dosing will then continue at the maximum dose achieved through Day 5.
16133800|NCT01906294|Drug|antidiabetic treatment (ATC A10B)|
16133801|NCT01906281|Other|Blood analyse, arthrocentesis, ultrasound examination|
16133802|NCT01906268|Other|Attentional Bias Modification Treatment (ABMT) - Active|"The ABMT consists of 160 trials (120 angry-neutral and 40 neutral-neutral presentations). In the ABM condition, the target appears at the neutral-face location in all angry-neutral trials. Probe type (< or >) is not factorially counterbalanced but appears with equal probability for each of the following: angry-face location, probe location, or actor.
~Number of sessions: 10 ABMT sessions, 5 weeks (2 sessions once a week occurring in the same day with 40 minutes interval)"
16133803|NCT01906268|Other|Attentional Bias Modification Treatment - Placebo|"The Placebo protocol consists of 160 trials (120 angry-neutral and 40 neutral-neutral presentations). In the placebo condition, angry-face location, probe location, and actor are fully counterbalanced in presentation.
~Number of sessions: 10 ABMT sessions, 5 weeks (2 sessions once a week occurring in the same day with 40 minutes interval)"
16133804|NCT01906242|Other|water|
16133805|NCT01906242|Other|sodium hypochlorite|
16133806|NCT01906242|Other|sodium bicarbonate|
16133807|NCT01906242|Other|chlorhexidine|
16133808|NCT01906216|Drug|Sorafenib|Sorafenib will be supplied as 200 mg tablets. All subjects will take two tablets of sorafenib (200 mg tablets) twice daily (each morning and evening).
16133809|NCT01906216|Procedure|TACE|"The first treatment of TACE should be completed within 3-7 days after the administration of sorafenib started. In all cases, TACE consists of an injection containing a mixture of chemotherapeutic agents and lipiodol followed by embolization with polyvinyl alcohol (PVA) or beads until complete stasis was achieved in the tumor-feeding vessels.Tumor-feeding vessels should be selected/superselected whenever possible. TACE will be repeated on demand depending on the radiological response."
16133810|NCT01906203|Device|body bioelectrical impedance performed by Z-Métrix (class IIa) - BIOPARHOM 12 allée des lacs de garde, Savoie Technolac BP 238, 73374 Bourget du lac, France|
16133811|NCT01906190|Biological|seasonal influenza vaccine|subjects whose antibodies less than 1:40 6 months later after primary vaccination will receive a booster dose of seasonal influenza vaccine
16133812|NCT01906164|Drug|ALS-008176|
16133813|NCT01906164|Drug|Placebo|
16133814|NCT01906151|Device|SENSIMED Triggerfish®|SENSIMED Triggerfish® (TF) is a CE-marked portable device that monitors the 24-hour intraocular pressure (IOP) pattern by a wireless contact lens sensor (CLS) placed on the eye that sends its signals wirelessly via a periorbital patched adhesive antenna to a recorder. Upon completion, the recording can be transmitted to a computer for read-out and visualization
16133815|NCT01906138|Device|SENSIMED Triggerfish®|All eligible patients will be assigned to 24-hour intraocular pressure recording using Triggerfish
16133816|NCT01906125|Drug|palbociclib capsule: phase 1 and 2 studies|125 mg dose of palbociclib. Formulation used in phase 1 and 2 studies
16133817|NCT01906125|Drug|Palbociclib capsule: phase 3 studies|125 mg dose of palbociclib. Formulation used in phase 3 studies
16133818|NCT01906125|Drug|Palbociclib capsule: ICH|125 mg dose of palbociclib. Intended final market formulation
16133819|NCT01906112|Procedure|Surgery for primary breast tumor.|Complete resection of primary breast tumor(Lumpectomy or mastectomy)
16133820|NCT01906099|Other|nutritional intervention|
16133821|NCT01906099|Other|life style modification|
16133822|NCT01906086|Other|nutritional intervention|
16133823|NCT01906086|Other|life style intervention|
16133824|NCT01906073|Drug|intranasal fentanyl spray|
16133825|NCT01906073|Drug|slow release morphine|
16133826|NCT01906060|Device|Air-Q Intubation Laryngeal Mask|Patients will be intubated using the Air-Q Laryngeal Mask.
16133827|NCT01906034|Behavioral|Exercise with supervision|
16133828|NCT01906034|Behavioral|Home-based without supervision|
16133829|NCT01906021|Procedure|CT/CBCT thermometry method|The study consists of acquiring one or maximum two additional CT or CBCT of the liver during hepatic RFA or MWA and analyzing the images to obtain a temperature map
16133830|NCT01906021|Procedure|Ablation Probe|Temperature measured with thermocouples (current clinically approved method consisting of invasive needle placement for point measurement in area of concern)
16133831|NCT01906008|Drug|Minocycline|200 mg by mouth for the first dose, then 100 mg by mouth every 12 hours for 4 months beginning at chemotherapy initiation.
16134127|NCT01903733|Drug|bosutinib|The starting bosutinib dose is 500 mg once daily, however the dose can vary from 300 mg to 600 mg.
16133833|NCT01906008|Behavioral|Questionnaires|Completion of questionnaires at baseline, 1 time each week, at each chemo cycle, at end of treatment visit, and at 6 month follow up visit.
16133834|NCT01906008|Behavioral|Sensory Test|Sensory test performed at baseline, 2 months, end of treatment visit, and at 6 month follow up visit.
16133835|NCT01905982|Procedure|reflectory breathing therapy|duration:2x60 minutes
16133836|NCT01905982|Procedure|conventional breathing therapy|duration:4x30 minutes
16133837|NCT01905956|Dietary Supplement|IQP-AK-102|IQP-AK-102 was presented in the form of a capsule containing proprietary, patent pending combination of three soluble fibres and excipients.
16133838|NCT01905956|Dietary Supplement|Placebo|The placebo contained microcrystalline cellulose and other excepients. Both active and placebo capsules had identical physical appearance in terms of size, shape, colour and opacity.
16133839|NCT01905943|Drug|Bendamustine|Bendamustine: 90 milligram per millilitre square (mg/m^2) IV over 60 minutes once daily (QD) Day 1-2 in participants previously untreated or 70 mg/m^2 I.V. over 60 minutes QD Day 1-2 in participants with relapsed/refractory disease. In non-fit participants only, investigators may opt at their own discretion to use lower initial doses of bendamustine, i.e., bendamustine 70 mg/m^2 in previously untreated participants, and bendamustine 50 mg/m^2 in relapsed/refractory subjects (over 60 minutes qd Day 1-2 for each administration).
16133840|NCT01905943|Drug|Chlorambucil|Chlorambucil 0.5 mg/kg p.o. qd on Day 1 and Day 15 in non-fit participants only.
16133841|NCT01905943|Drug|Cyclophosphamide|Cyclophosphamide 250 mg/m^2 I.V. over 15-30 minutes qd Day 1-3 or Cyclophosphamide 250 mg/m^2 p.o. QD Day 1-3 in fit participants only.
16133842|NCT01905943|Drug|Fludarabine|Fludarabine 25 mg/m^2 I.V. over 30 minutes QD Day 1-3 or Fludarabine 40 mg/m^2 per os (p.o.) QD Day 1-3 in fit participants only.
16133843|NCT01905943|Drug|Obinutuzumab|Participants will receive obinutuzumab 1000 mg IV infusion on Days 1/2 (dose split over 2 consecutive days; 100 mg on Day 1 and 900 mg on Day 2), 8 and 15 of cycle 1, and on Day 1 of Cycles 2, 3, 4, 5, and 6. Each cycle is of 28-days duration.
16133844|NCT01905930|Device|PCM Cervical Disc|Patients enrolled in the IDE clinical study and treated with the PCM Cervical Disc to treat degenerated cervical discs and neurological symptoms at one level from C3 to T1
16133845|NCT01905930|Device|Anterior Cervical Discectomy and Fusion (ACDF)|Patients enrolled in the IDE clinical study and treated with an anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
16133846|NCT01905917|Other|Tele-rehabilitation|
16133847|NCT01905904|Drug|sevorane|Sevorane 4% Sevorane 7%
16133848|NCT01905891|Procedure|Superficial shave biopsy|Sample will be obtained from random dorsal forearm skin sites without evidence of keratotic lesions. The site will be selected by the investigator. Skin will first be wiped with an alcohol pad and 1% lidocaine will be superficially infiltrated per standard skin surgical procedures. 30% trichloroacetic acid (TCA, standard chemical peel) will then be applied for five minutes. TCA will be neutralized using bicarbonate. Using a cytology brush (a small brush which is used to collect cells during the course of a biopsy) cells will be collected by gentle scraping surface of the skin. Then, a superficial shave biopsy specimen, obtained by using a dermablade (a flexible, one piece blade specifically designed for shave biopsy and excision of skin lesions) will be obtained.
16133849|NCT01905878|Drug|DLBS1033|
16133850|NCT01905813|Drug|INCB040093|Escalating doses starting at 100 mg every day (QD)
16133851|NCT01905813|Drug|INCB040093|INCB040093 monotherapy - dose to be determined at completion of Phase I of the study
16133852|NCT01905813|Drug|INCB040093 + itacitinib|INCB040093 dose to be determined at completion of Part 1 of the study + itacitinib at a starting dose of 400 mg, QD with escalations planned up to 600 mg QD.
16133853|NCT01905800|Device|Biaxial rotational chair|This chair has a vertical and a horizontal axis of rotation and is lockable in preset positions. It is manually handled and can swivel between two axes in all planes of the semicircular canals for up to 360 degrees or more. Velocity of rotation can be regulated freely.
16133854|NCT01905774|Drug|Deferasirox|
16133855|NCT01905748|Other|Laboratory tests|Laboratory tests: erythrocyte sedimentation rate (ESR), Blood Count, C reactive Protein, Protein C activity, Protein S activity,Antithrombin II activity, Coagulation Factor VIII and IX,Con Willebrand Factor, prothrombin time (PT), activated partial thromboplastin time (aPTT), Fibrinogen, D Dimer and Prothrombin Fragments F1 and F2.
16133856|NCT01905735|Drug|Rhustoxicodendron 30|1/2ml Rhustoxicodendron 30 is administered orally every 7 day for 5 month.
16133857|NCT01905735|Drug|placebo|1/2 ml of dispensing alcohol is administered every 7 day for 5 month orally.
16133858|NCT01905722|Other|3 Tesla|3 Tesla scanning with intravenous infusion of tracers
16133859|NCT01905722|Other|7 Tesla|7 Tesla scanning with intravenous infusion of tracers
16133860|NCT01905709|Biological|Human fecal matter|
16133861|NCT01905696|Drug|Oral N-acetylcysteine|
16133862|NCT01905683|Drug|IncobotulinumtoxinA (16-20 Units per kg body weight)|Active ingredient: Clostridium Botulinum neurotoxin type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl); Total dose per injection cycle: up to 500 units; Mode of administration: intramuscular injection into spastic muscles.
16133863|NCT01905670|Device|WiCS-LV system|Wireless cardiac stimulator implant to pace the left ventricle for CRT Transvascular endocardial implantation of wireless pacing Electrode and subcutaneous implantation of Implantable Pulse Generator
16133864|NCT01905657|Biological|Pembrolizumab|IV infusion
16133865|NCT01905657|Drug|Docetaxel|IV infusion
16133866|NCT01905644|Procedure|Perineal ultrasound|Perineal ultrasound will be used after delivery to help detect anal sphincter ruptures.
16133867|NCT01905631|Drug|Aurstat Anti-Itch Hydrogel (Aurstat)|Subjects will apply Aurstat Anti-Itch Hydrogel 2 times daily or as needed for up to three days to reduce itching. Subjects will also fill out a study diary assessing adverse events or other events they experience during the trial.
16133908|NCT01905332|Other|Literacy promoting home based program|The Columbus Metropolitan Library (CML) has an early childhood literacy program, known as Ready to Read. It aims to reach parents and caregivers of children birth to five and share easy literacy-building activities that parents can use at home with their children. Ready to Read Corp members offer 5-6 home visits at no cost, educating parents on early literacy activities in the home.
16133868|NCT01905618|Behavioral|Web-based curriculum on tobacco dependence treatment|"The University of Massachusetts Medical School's web-based course, Basic Skills for Working with Smokers was adapted for this Randomized Controlled Trial (RCT). The goal is to provide standardized information in the following core tobacco content areas: epidemiology of tobacco use, health consequences of tobacco use, nicotine dependence and withdrawal assessment, and provision of behavioral and pharmacotherapy tobacco treatment. The course is 3 hours in length and can be completed at the student's convenience. The dean and the course director at each medical school required that the first year medical students complete the web-based curriculum prior to the next component of the study, the role play."
16133869|NCT01905618|Behavioral|Tobacco Counseling Role Play|The goal of the role play is to provide each student with the opportunity to apply what he/she learned in the web-based curriculum (the 5 As and the physician delivered intervention approach). The one hour session begins with a video of a patient-centered counseling approach which incorporates the 5A intervention presented in the web-based course. This is followed by a 30 minute role play session including various scenarios with physician/patient interaction. Students role play either as physician, patient or observer for each scenario.
16133870|NCT01905618|Behavioral|Preceptor Training and Teaching Medical Students|The goal of this intervention is to train preceptors in the use of the 5As with their patients and to teach and motivate their medical students to use the 5As. The academic detailing approach is used to provide a standardized 30 to 45 minute group training session during the third year clerkship. All preceptors and medical students are encouraged to intervene with patients who smoke. Preceptors are encouraged to model the 5As, observe and give feedback to the medical student in its use. Study-tailored handouts are available for preceptors and students. This component is implemented with the study cohort in their third year of medical school.
16133871|NCT01905618|Behavioral|Booster Session|The last component of the intervention, a small group booster session, occurs during the third year of medical school. A five minute video reviews the use of the 5As and patient-centered counseling strategies. Faculty facilitate a small group discussion after viewing the video.
16133872|NCT01905605|Drug|phosphatidylcholine supplementation|phosphatidylcholine concentrate 700 mg twice per day
16133873|NCT01905605|Drug|placebo|placebo manufactured look like phosphatidylcholine concentrate dosed at 1.2 ml twice per day
16133874|NCT01905592|Drug|niraparib|300 mg (3x100 mg capsules) once daily until progression or unacceptable toxicity develops
16133875|NCT01905592|Drug|Physician's choice|Choice of 4 standard of care metastatic breast cancer chemotherapies, until progression or unacceptable toxicity develops
16133876|NCT01905579|Procedure|Paracentesis of the anterior chamber|Aqueous humor parenthesis for quantitative protein analysis in patients with and without uveitis.
16133877|NCT01905566|Drug|Clopidogrel|75mg once a day
16133878|NCT01905566|Drug|Ticagrelor|90mg twice a day
16133879|NCT01905553|Drug|SSP-004184SS|Disodium salt
16133880|NCT01905540|Drug|SSP-004184AQ|Magnesium salt
16133881|NCT01905540|Drug|SSP-004184SS|Disodium salt
16133882|NCT01905527|Other|Standard Services of Group A (Group A1)|Support services provided in this group will include: Initial field nurse injection training visit; field nurse follow-up and subsequent visits; and follow-up phone calls at periodic intervals
16133883|NCT01905527|Other|Customized Services of Group A (Group A2)|In addition to the initial field nurse injection training visit and follow-up call, subjects will select from support services including field nurse follow-up visits; follow-up phone calls; email and/or text reminders; subject self-assessment and use of treatment planning tools; and mail/e-mail educational materials.
16133884|NCT01905527|Other|Group B|Support services provided in this group will include initial field nurse injection training visit and follow-up phone calls at periodic intervals.
16133885|NCT01905514|Device|internet mobile application|
16133886|NCT01905501|Drug|Balanced anesthesia|Et-Sevo maIntained 1,8-2%, remifentanyl according target-controlled infusion maintained 1-3 ng/ml
16133887|NCT01905501|Drug|Total intravenous anesthesia|Propofol 3-4 µg/ml and remifentanyl 1-3 ng/ml according target-controlled infusion
16133888|NCT01905475|Drug|POL6326|
16133889|NCT01905475|Drug|Placebo|
16133890|NCT01905462|Other|Data Collection|Analyses of data collected within the CPRD GOLD database.
16133891|NCT01905462|Biological|Cervarix|Women with last menstrual period (LMP) between 30 days before and 45 days after, or 30 days before and 90 days after any dose of Cervarix and women with LMP between 120 days and 18 months after the last Cervarix dose.
16133892|NCT01905449|Behavioral|Ultrasound visual feedback|Real-time visual displays of the tongue are used to cue participants to modify the tongue position/shape as they articulate speech sounds
16133893|NCT01905436|Drug|Annual versus Semiannual Albendazole plus Ivermectin Mass Drug Administration|Annual or semiannual Albendazole plus Ivermectin, administered by the Liberian Ministry of Health.
16133894|NCT01905423|Drug|Albendazole (annual)|Albendazole 400 mg pnce annually
16133895|NCT01905423|Drug|Diethylcarbamazine (annual)|Diethylcarbamazine 6 mg/kg once annually
16133896|NCT01905423|Drug|Albendazole (semiannual)|Albendazole 400 mg twice annually
16133897|NCT01905423|Drug|Diethylcarbamazine (semiannual)|Diethylcarbamazine 6 mg/kg twice annually
16133898|NCT01905410|Drug|VVZ-149 Injection|VVZ-149 in water for injection
16133899|NCT01905410|Drug|placebo|water for injection
16133900|NCT01905397|Device|Conventional wound therapy|Sterile bandages and wound coverings
16133901|NCT01905397|Device|Negative pressure wound therapy|The Prevena Incision Management System covers and protects the incision from external infectious sources, while negative pressure removes fluid and infectious material from the surgical incision. The ActiVAC pump may be used with the Prevena dressings as well in some situations to achieve negative pressure.
16133902|NCT01905384|Device|Covered Self-expanding metal biliary stents (C-SEMS)|Used for palliation of inoperable malignant distal bile duct obstruction.
16133903|NCT01905384|Device|Uncovered Self-expanding metal biliary stents (U-SEMS)|Used for palliation of inoperable malignant distal bile duct obstructions.
16133904|NCT01905371|Drug|Dextroamphetamine|
16133905|NCT01905371|Other|Physical Therapy|One hour of active physical therapy (PT) directed at a primary motor impairment. An outline indicating a range and level of physical therapy interventions will be provided to the therapists, and the level and of therapy will be recorded.
16133906|NCT01905371|Drug|Placebo|
16133909|NCT01905332|Other|Literacy Toolkit|Package of books, games, and multi-sensory toys to facilitate the development of emergent literacy skills.
16133910|NCT01905319|Other|Blood collecting for storage of samples|
16133911|NCT01905306|Procedure|computer guided implant planning|
16133912|NCT01905306|Procedure|free hand implants placement|
16133913|NCT01905293|Other|Feeding Study|
16133914|NCT01905280|Procedure|Non-resorbable membrane|The ridge preservation graft will be covered with a non-resorbable PTFE membrane during the surgery.
16133915|NCT01905280|Procedure|Acellular dermal matrix|The ridge preservation graft will be covered with an acellular dermal matrix allograft during the surgery.
16133916|NCT01905267|Behavioral|Rumination-Focused Cognitive Behavior Therapy|This intervention targets rumination and other maladaptive forms of emotion regulation such as suppression and avoidance and provides skills training in effective coping strategies. Mindfulness is a key component of this intervention as a strategy for disengaging from one's thoughts. Strategies from Dialectical Behavior Therapy (DBT), such as the use of effective interpersonal skills, are also included as methods for regulating strong emotion. Rumination-Focused Cognitive Behavior Therapy is a structured, manual based program designed to be delivered weekly over eight weeks. Sessions are 60-90 minutes in length.
16133917|NCT01905254|Device|Transient elastography (TE)|TE and minilaparoscopic guided liver biopsy were performed by physicians blinded to the results the other within a period of less than 3 months.
16133918|NCT01905254|Other|Liver biopsy|Minilaparoscopic guided liver biopsy was performed within a period of 3 months of Transient Elastography
16133919|NCT01905241|Device|Anatomic TSA using RTI|Anatomic Total Shoulder Arthroplasty (TSA) will be performed using the SmartBone and Real Time Instrumentation (RTI) to transfer the preoperative plan for glenoid implant positioning to the patient's anatomy.
16133920|NCT01905241|Procedure|Anatomic Total Shoulder Arthroplasty|Anatomic Total Shoulder Arthroplasty will be performed by the two surgeons of the study as their Standard of Care. All procedures associated with the surgery will be the same with the exception of the instrumentation used to place the guide pin for placement of the glenoid implant.
16133921|NCT01905228|Drug|CBL0137|"All doses are administered intravenously on Days 1, 8 and 15 of every 28 day cycle.
~Number of Cycles: 2 or until progression or unacceptable toxicity develops"
16133922|NCT01905215|Biological|RSV vaccine GSK3003892A (formulation 1)|Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule
16133923|NCT01905215|Biological|RSV vaccine GSK3003893A (formulation 2)|Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule
16133924|NCT01905215|Biological|RSV vaccine GSK3003895A (formulation 3)|Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule
16133925|NCT01905215|Biological|RSV vaccine GSK3003896A (formulation 4)|Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule
16133926|NCT01905215|Biological|RSV vaccine GSK3003898A (formulation 5)|Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule
16133927|NCT01905215|Biological|RSV vaccine GSK3003899A (formulation 6)|Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule
16133928|NCT01905215|Drug|Placebo comparator|Intramuscular (IM) vaccination in the deltoid region of the non-dominant arm at Day 0 according to protocol schedule
16133929|NCT01905202|Drug|Secretrol|
16133930|NCT01905189|Procedure|Resynchronization therapy of right ventricle|Right atrio-ventricular resynchronization therapy combined with right intra-ventricular resynchronization therapy
16133931|NCT01905176|Other|In person education on heart failure topics before discharge|Individualized in-person education on HF topics aiming to promote self-care practices by using educational electronic material and booklet
16133932|NCT01905176|Other|Telephone support and education post-discharge|Individualized telephone support/education of three months duration, on HF topics, aiming to promote self-care practices while evaluating patients' current status and condition
16133933|NCT01905176|Other|Pre-discharge in person education and post-discharge telephone education and support|Patients receive both interventions of Arm 1 & 2: individualized pre-discharge counseling/education along with telephone follow-up support for three months, following the same line as mentioned in Arms 1 & 2
16133934|NCT01905163|Procedure|Tumor Debulking Surgery by laparoscopy|
16133935|NCT01905150|Drug|G-FLIP|G-FLIP is a combination of Low Doses of Gemcitabine, Fluorouracil [5FU], Leucovorin, Irinotecan, and Oxaliplatin
16133936|NCT01905150|Drug|G-FLIP-DM|G-FLIP-DM is low doses of Gemcitabine, Fluorouracil [5FU], Leucovorin, Irinotecan, Oxaliplatin, Docetaxel and Mitomycin C
16133937|NCT01905150|Dietary Supplement|Vitamin C|High dose of Vitamin C, used in combination with G-FLIP and then G-FLIP-DM
16133938|NCT01905137|Drug|Intervention-Botulinum Toxin Type A|Patients will receive 200 units of Botulinum Toxin A diluted in 20 mL of preservative free saline to their pelvic floor followed by pelvic floor physical therapy.
16133939|NCT01905137|Drug|placebo|
16133940|NCT01905124|Drug|CF101|CF101 1 mg tablets orally every 12 hours for 24 weeks
16133941|NCT01905124|Drug|Placebo|Matching placebo tablets orally every 12 hours for 24 weeks
16133942|NCT01905111|Drug|BI 853520|BI 853520 once daily in a dose escalation schedule
16133943|NCT01905098|Other|Sauna Detoxification Protocol|"All study participants will actively undergo sauna intervention sessions.
~The sauna will be pre-warmed to 160 degrees Fahrenheit and humidity set to 25% +/- 5%. Participants will have a scheduled 10-min break every 30 minutes of sauna, during which time vital signs, symptoms, and fluid intake will be assessed and recorded.
~On a weekly basis, lab assessments will be performed to compare participants' baseline lab values with those during the sauna intervention, and to monitor for safety. In addition, weekly serum samples will be taken for PCB assessment."
16133944|NCT01905098|Other|Observation Sessions|All enrolled participants will undergo observation protocol consisting of one (1) hour visit weekly consistent with Sauna Visits lab assessment time points, to be completed in 3 weeks (4 total sessions within 21 days). At each Observation Visit a blood draw for CBC/D, CMP, and PCBs analysis will be performed, as well as query for symptoms and MOSES questionnaire will be assessed.
16133945|NCT01905085|Device|No intervention|
16134171|NCT01903330|Drug|ERC1671|Given intradermally
16133946|NCT01905072|Other|Education Home Visits|"Intervention will include educational home visits on:
~Growth monitoring and feedback
~Feeding: support exclusive breastfeeding until 6 months; delay solid feeding until 6 months; appropriate amounts of food for age; stop bottle feeding at 12 months; have nothing but breast milk/formula/4 oz juice in bottle; limit juice amount to 4 oz day; introduce cup by 10-11 months; no sweetened beverages; limited amounts of sweets.
~Parenting: recognizing hunger and satiety cues; handling colic/crying; engaging baby in play.
~Activity: being active with the baby; no screen time for baby and limited to 1 hour for 1-3 year olds; promote active play while maintaining safety.
~Sleep: at least 10-12 hours sleep per day needed; how to promote sleeping environment for baby."
16133947|NCT01905059|Drug|monoPI - boosted lopinavir or boosted darunavir|boosted lopinavir (LPV/rtv 200/50 mg 2 tbs BID) or boosted darunavir (DRV 400 mg 2 tbs plus RTV 100 mg QD) This arm was stopped by the Scientific Committee on advise of the DSMB after interim analysis showing increased risk of failure for these participants. Participants are switched to standard second line triple therapy and will be followed until the last visit at week 96.
16133948|NCT01905059|Drug|bi therapy - (boosted lopinavir or boosted darunavir) + lamivudine|boosted lopinavir (LPV/rtv 200/50 mg 2 tbs BID) with lamivudine 300 mg QD or boosted darunavir (DRV 400 mg 2 tbs plus RTV 100 mg QD)with lamivudine 300 mg QD. This arm is going on, patients will be followed on this intervention until the end of the study at week 96
16133949|NCT01905046|Drug|metformin hydrochloride|given PO
16133950|NCT01905046|Other|placebo|given PO
16133951|NCT01905020|Other|Carbohydrate-rich meal|At 19:30, patients will eat a standardized large meal (110g carbohydrate for males; 90g carbohydrate for females). Conventional insulin pump therapy or closed-loop system will be use to control glucose levels from 21:00 until 7:00 next morning.
16133952|NCT01905020|Other|Exercise|Study participants will go to a training facility around 18:00 to perform a 60min workout at 60% heart rate reserve. The workout will be on a treadmill and/or a stationary bicycle. Conventional insulin pump therapy or closed-loop system will be use to regulate glucose levels from 21:00 until 7:00 next morning.
16133953|NCT01905007|Device|Defibrillation testing|Defibrillation testing at initial ICD implantation
16133959|NCT01904981|Drug|Beta-blocker-Atenolol 50mg, PO(peroral), Once daily|
16133960|NCT01904981|Drug|Angiotensin receptor blocker-Valsartan 80mg, PO(peroral), Once daily|
16133961|NCT01904929|Other|Walk-tests|"Patients will make a 6-minute-walk-test, the 400m-walk-test and a 200m-fast walk test. These first 2 tests (TM6min and TML400m) will be made in an order determined by randomization.
~This series of test will be repeated 72 hours later for the study reproducibility.
~It will be followed by a phase of rest of 15 min and a test of effort on travelator, according to the protocol of  modified Bruce  in moderation of portable VO2."
16133962|NCT01904916|Procedure|Histological biopsy procedure|
16133963|NCT01904903|Drug|Trastuzumab|HER2 therapy
16133964|NCT01904903|Drug|Pertuzumab|HER2 therapy
16133965|NCT01904903|Drug|Ado Trastuzumab Emtansine|HER2 therapy
16133966|NCT01904890|Behavioral|CRC Prevention and Screening Education|Refer to Arm Description
16133967|NCT01904890|Behavioral|Nutrition Education|Refer to Arm Description
16133968|NCT01904877|Behavioral|Enhancing HIV testing|SMS-I intervention by cell phones, web advertisement, community outreach, and peer referral strategies to recruit MSM in Beijing City for receiving HIV testing
16133969|NCT01904864|Drug|elemental iron (NovaFerrum®)|single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation, NovaFerrum®, for 12 weeks
16133970|NCT01904864|Drug|elemental iron (Ferrous Sulfate)|single daily dose (3mg/kg) of a 15 mg/ml elemental iron preparation, Ferrous Sulfate, for 12 weeks
16133971|NCT01904812|Other|Questionnaire about quality of life and satisfaction|
16133972|NCT01904799|Other|Cognitive Assessment test|
16133973|NCT01904786|Drug|Melatonin|
16133974|NCT01904786|Drug|placebo|
16133975|NCT01904773|Drug|AZD5213 and placebo|low dose AZD5213 capsules; high dose AZD5213 capsules; placebo capsules
16133976|NCT01904760|Drug|Dexmedetomidine|Dexmedetomidine(4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day.
16133977|NCT01904760|Drug|Saline placebo|Normal saline 0.9% (guess as 4㎍/mL) : 0.5㎍/kg/hr infusion for 1 hour before operation is completed and 0.2-0.7㎍/kg/hr infusion continuously until 6:00am the next day
16133978|NCT01904747|Drug|Palbociclib administered Fasted|palbociclib given under fasting 10 hrs overnight; capsule form, 125 mg single dose
16133979|NCT01904747|Drug|Palbociclib administered Fed high calorie|palbociclib given right after a high fat high calorie meal; capsule form, 125 mg single dose
16133980|NCT01904747|Drug|Palbociclib administered Fed low calorie|palbociclib given right after a low fat low calorie meal; capsule form, 125 mg single dose
16133981|NCT01904747|Drug|Palbociclib administered Fed moderate calorie|palbociclib given between moderate calorie meal; capsule form, 125 mg single dose
16133982|NCT01904734|Drug|Clomiphene|Start with 25 mg and escalate to 50 mg in men not achieving goal for serum testosterone after 3 weeks
16133983|NCT01904721|Drug|Bimatoprost Solution 1|Bimatoprost Solution 1 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
16133984|NCT01904721|Drug|Bimatoprost Solution 2|Bimatoprost Solution 2 applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
16133985|NCT01904721|Drug|Bimatoprost Vehicle|Bimatoprost Vehicle (placebo) applied evenly onto pre-specified area on the scalp daily for 28 days, or daily for 6 months.
16133986|NCT01904708|Other|Acute Moderate Intensity Exercise|Moderate intensity exercise by walking on a treadmill at 75% of max heart rate.
16133987|NCT01904695|Drug|Herbs|Herbs 180ml by mouth every 12 hours for 8 weeks
16133988|NCT01904695|Drug|Antihypertensive drugs|Thiazide diuretics and ACE inhibitor and β-blocker in different dosage determined by the physician for 8 weeks
16133989|NCT01904682|Drug|Oral rigosertib|Dose of 560 mg consists of two (2) 280 mg soft gel capsules of rigosertib.
16133990|NCT01904656|Behavioral|"Get Behind your health"|"Participants are exposed to the Get Behind Your Health! media campaign intervention comprising 3 phases: the media campaign, the medical chart reminder, and a combination of media campaign and chart reminder. Participants also undergo telephone interviews during years 2-4."
16133991|NCT01904656|Behavioral|Peaches|"Participants are exposed to a Healthy Eating! media campaign intervention comprising 3 phases: the media campaign, the medical chart reminder, and a combination of media campaign and chart reminder. Participants also undergo telephone interviews during years 2-4."
16133992|NCT01904643|Drug|lenalidomide|Given PO
16133993|NCT01904643|Drug|mitoxantrone hydrochloride|Given IV
16133994|NCT01904643|Drug|etoposide|Given IV
16133995|NCT01904643|Drug|cytarabine|Given IV
16133996|NCT01904630|Genetic|gene sequencing|Gene sequencing by exome capture and high throughput sequencing for identification of rare variants
16133997|NCT01904617|Other|Dextrose|
16133998|NCT01904617|Other|Normal Saline|
16133999|NCT01904604|Biological|Placebo Viaskin® Patch|Placebo (e.g., no peanut) patch in an epicutaneous application for 24 hours every 24 hours.
16134000|NCT01904604|Biological|Low-dose DBV712 Viaskin® Patch|100 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.
16134001|NCT01904604|Biological|High-dose DBV712 Viaskin® Patch|250 microgram (µg) dose of peanut proteins in an epicutaneous application for 24 hours every 24 hours.
16134002|NCT01904591|Dietary Supplement|Selenium|"Selenium 50 micrograms daily per oral
~1 year of treatment"
16134003|NCT01904591|Dietary Supplement|Vitamin E|"Vitamin E 400 international units daily per oral
~1 year of treatment"
16134004|NCT01904578|Other|true accupressure|Four acupoints were chosen for subjects in the acupressure group. They were Shenmen on the wrist crease, Sanyinjiao point (SP6) on both feet, Fengchi on the hairline of the back neck (occipital area)and Yintang, at the top of the nose on the center line between the ends of the eyebrows.
16134005|NCT01904578|Other|sham acupressure|Non-acupoints, which were 1 to 3 traditional Chinese unit of length (CUN) away from true acupoints, were used in sham acupressure group.These points were out of the route of energy
16134006|NCT01904565|Radiation|Hyperthermia and Proton Beam|"Local hyperthermia,once a week for 5 to 7 weeks to a temperature of 41.5 to 42.5 degree Centigrade
~Proton beam therapy, 5 days a week at 1.8 - 2.0 GyE per fraction to a dose of 55 - 60 GyE (preoperative) or 72 - 76 GyE (for radical. Patients who have good response at 5 weeks of treatment would be considered for preoperative treatment, while those with unsatisfactory response that could be taken up for at least R0 resection would be treated to a radical dose."
16134007|NCT01904552|Device|Electronic Root Canal Length Measurement Device|Electronic Apex Locator is used to find the apical foramen of the root canal. It uses a weak electrical current passed through the canal by endodontic file
16134008|NCT01904539|Drug|obeticholic acid 10 mg|Single dose OCA 10mg in each arm
16134009|NCT01904526|Drug|Guanfacine|3mg/day IR with 3-week lead-in period. Maintained at steady state to complete lab session. After completion of lab session, 1-week lead-in medication period to 4mg/day ER. Maintained at steady state to complete lab session. After completion of lab session, 1-week lead-in medication period to 6mg/day ER. Maintained at steady state to complete lab session. 5-day taper after lab.
16134010|NCT01904513|Dietary Supplement|Pasteurized Whole Milk|
16134011|NCT01904513|Dietary Supplement|Lactobacillus rhamnosus GR-1|
16134012|NCT01904500|Drug|Pre-operative cefazolin|
16134013|NCT01904487|Radiation|[11C]flumazenil|[11C]flumazenil is a radiotracer used to measure levels of the neurotransmitter GABA in the human brain.
16134014|NCT01904487|Drug|Tiagabine|Tiagabine raises levels of GABA in the brain. It is used in this study so that we can measure the changes in GABA levels.
16134015|NCT01904474|Other|Next.Step - e-therapeutic intervention program|
16134016|NCT01904474|Other|Standard treatment protocol|
16134017|NCT01904461|Device|Vacuum device|
16134018|NCT01904461|Procedure|Conventional surgery|
16134019|NCT01904448|Device|Auditory Brainstem Implantation in Children|
16134020|NCT01904422|Procedure|conventional periodontal treatment|
16134021|NCT01904409|Drug|Placebo|
16134022|NCT01904409|Drug|Rifaximin SSD 40 mg IR tablet|
16134023|NCT01904409|Drug|Rifaximin SSD 80 mg IR tablet|
16134024|NCT01904409|Drug|Rifaximin SSD 40 mg SER tablet|
16134025|NCT01904409|Drug|Rifaximin SSD 80 mg SER tablet|
16134026|NCT01904409|Drug|Rifaximin SSD 80mgIR/80mgSER tablet|
16134027|NCT01904396|Drug|Carnitine|Patients who are found to be carnitine deficient will be started on carnitine replacement and their heart function will be monitored on carnitine.
16134028|NCT01904383|Drug|Trazenta|1 tablet of 5 mg Trazenta tablets once daily
16134029|NCT01904357|Drug|Cefazolin 1 GM Injection|Subjects weighing ≥25 kg and < 50 kg will receive the 1g dose.
16134030|NCT01904357|Drug|Cefazolin 2 GM Injection|Subjects weighing ≥50 kg to ≤85 kg will receive the 2g dose.
16134031|NCT01904344|Device|Sensor testing and validation|
16134032|NCT01904318|Drug|IDP-73152 mesylate 40 mg|IDP-73152 mesylate 40 mg single dose administration
16134033|NCT01904318|Drug|IDP-73152 mesylate 80 mg|IDP-73152 mesylate 80 mg single dose administration
16134034|NCT01904318|Drug|IDP-73152 mesylate 160 mg|IDP-73152 mesylate 160 mg single dose administration
16134035|NCT01904318|Drug|IDP-73152 mesylate 320 mg|IDP-73152 mesylate 320 mg single dose administration
16134036|NCT01904318|Drug|IDP-73152 mesylate 640 mg|IDP-73152 mesylate 640 mg single dose administration
16134037|NCT01904318|Drug|IDP-73152 mesylate 1280 mg|IDP-73152 mesylate 1280 mg single dose administration
16134038|NCT01904318|Drug|Placebo|Placebo single dose administration
16134039|NCT01904292|Drug|Tocilizumab|Subcutaneous 162 mg dose QW or Q2W for 52 weeks
16134040|NCT01904279|Drug|Tocilizumab|Participants will receive 162 mg of TCZ as SC injection Q3W or Q2W for 52 weeks
16134041|NCT01904266|Procedure|GA + paravertebral block|20 cc ropivacaine 0.2% will be administered in an ultrasound-guided paravertebral block
16134042|NCT01904266|Procedure|GA + sham block|Injection of 1 cc saline subcutaneously
16134043|NCT01904253|Drug|TAS-102|35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.
16134044|NCT01904253|Drug|Amrubicin (Japan)|Patients will receive treatment administered according to the country-specific approved prescribing information
16134045|NCT01904253|Drug|Topotecan (Japan/Europe)|Patients will receive treatment administered according to the country-specific approved prescribing information
16134046|NCT01904227|Behavioral|standard outpatient DBT|Patients receive 12 months of outpatient treatment as specified in the DBT manual (Linehan, 2002) in one of the participating regional psychiatric centers of Rivierduinen. The treatment is according to protocol and combines weekly individual cognitive-behavioral psychotherapy sessions with the primary therapist, weekly skills- training groups, if needed consultation and weekly consultation meetings for trainers and therapists.
16134047|NCT01904227|Behavioral|Inpatient Adaptation of DBT|"The intervention to be studied, inpatient DBT, consists of an inpatient program of 12 weeks. The department provides accommodation for 9 patients. Patients are admitted 5 days a week at the department Oost, part of the Jelgersma centre for Personality Disorders. Staff is only present in daytime. During the weekends the patients stay at home.
~The therapy consists of DBT skills training (Linehan, 1996), individual psychotherapy (Linehan, 2002), crisis consultation if needed, and weekly meetings of the consultation team for all trainers and therapists for one hour. Staff also receives supervision twice-weekly."
16134048|NCT01904214|Drug|BAF312|Treatment with a single oral dose of 0.25 mg BAF312
16134049|NCT01904188|Device|Gene Z or other rapid diagnostic techniques developed in our lab (as of 2018 not using Gene Z regularly)|The Gene Z device or other rapid diagnostic techniques that we have developed in our lab will be used to analyze previously processed specimens for microbial organisms and compared to prior culture and sensitivity results. It is not a separate arm - all samples will be cultured in lab per standard protocol and then the Gene Z device or other rapid diagnostic techniques developed in our lab will be used to re-analyze at a later date specimens that were previously frozen and stored and compared to culture results
16134050|NCT01904162|Drug|400 mg finafloxacin (2 x 200 mg tablets)|
16134051|NCT01904149|Drug|Placebo|Placebo single oral dose (first 8 hours)
16134052|NCT01904149|Drug|Dexketoprofen-single dose|Dexketoprofen single oral dose (first 8 hours)
16134053|NCT01904149|Drug|Tramadol-single dose|Tramadol single oral dose (first 8 hours)
16134054|NCT01904149|Drug|Dexketoprofen/Tramadol-single dose|Dexketoprofen/Tramadol single oral dose (first 8 hours)
16134055|NCT01904149|Drug|Dexketoprofen-multiple doses|Dexketoprofen multiple oral doses t.i.d. for 3 days (total 6 doses)
16134056|NCT01904149|Drug|Tramadol-multiple doses|Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses)
16134057|NCT01904149|Drug|Dexketoprofen/Tramadol-multiple doses|Dexketoprofen/Tramadol multiple oral doses t.i.d. for 3 days (total 6 doses)
16134058|NCT01904136|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic PBSC or bone marrow transplant
16134059|NCT01904136|Procedure|Bone Marrow Transplantation|Undergo allogeneic PBSC or bone marrow transplant
16134060|NCT01904136|Drug|Cyclophosphamide|Given IV
16134061|NCT01904136|Drug|Fludarabine|Given IV
16134062|NCT01904136|Other|Laboratory Biomarker Analysis|Correlative studies
16134063|NCT01904136|Drug|Melphalan|Given IV
16134064|NCT01904136|Drug|Mycophenolate Mofetil|Given PO
16134065|NCT01904136|Biological|Natural Killer Cell Therapy|Given IV
16134066|NCT01904136|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo allogeneic PBSC or bone marrow transplant
16134067|NCT01904136|Drug|Tacrolimus|Given IV and PO
16134068|NCT01904136|Radiation|Total-Body Irradiation|Undergo TBI
16134069|NCT01904123|Other|Laboratory Biomarker Analysis|Correlative studies
16134070|NCT01904123|Other|Pharmacological Study|Correlative studies
16134071|NCT01904123|Drug|STAT3 Inhibitor WP1066|Given PO
16134072|NCT01904110|Drug|Risedronate/Cholecalciferol combination(montly)|once a month
16134073|NCT01904110|Drug|Risedronate/Cholecalciferol combination(weekly)|once a week
16134074|NCT01904097|Drug|Pregabalin|Pregabalin 150 mg per oral BID (i.e. twice per day).
16134075|NCT01904097|Other|Transcranial Direct Current Stimulation|The tDCS consists of application of low intensity direct current (2 mA), with the anode placed in the dominant motor cortex (M1) and the cathode in the ipsilateral supraorbital region during 30 minutes each session, using sponge electrodes soaked with normal saline solution.
16134123|NCT01903785|Drug|Salbutamol|60 minutes prior to the start of a 10km cycling time trial on a bike ergometer, subjects will inhale either 400ug of salbutamol 1600ug of salbutamol or 400ug of placebo in a randomly assigned manner in a single dose.
16134076|NCT01904097|Other|Sham Transcranial Direct Current Stimulation|The sham tDCS consists of the same montage of the active tDCS, but the device is turned off 30 seconds after initiating stimulation (without letting the patient notice it). Rest of the montage is kept identical as the active one during the 30 minutes that the session lasts.
16134077|NCT01904084|Device|Volar locked plating|Operative treatment of distal radius fracture with volar locking plate
16134078|NCT01904084|Device|Hoffman external fixator|Patients with distal radius fracture operated with Hoffman external fixator
16134079|NCT01904071|Procedure|UFNB (Ultrasound guided femoral nerve block)|Ultrasound Guided Femoral Nerve Block
16134080|NCT01904071|Procedure|UFIB (Ultrasound Guided Fascia Iliaca Compartment Block)|
16134081|NCT01904071|Drug|IVMS (IV Morphine)|Intravenous Morphine
16134082|NCT01904058|Drug|LUM001|
16134083|NCT01904058|Drug|Placebo|
16134084|NCT01904058|Drug|Ursodeoxycholic Acid|
16134085|NCT01904045|Other|tacrolimus Advagraf|intake of Advagraf once daily for 3 months
16134086|NCT01904045|Other|tacrolimus Prograf|intake of Prograf twice daily for 3 months
16134087|NCT01904032|Drug|Vitamin D3|50,000 international units (IUs) weekly Vitamin D3
16134088|NCT01904032|Drug|Vitamin D3 comparator|5,000 international units (IUs) of a weekly Vitamin D3 comparator
16134089|NCT01904006|Procedure|New Culture Condition|Intervention group embryos cultured grouped (5 embryos per drop) under low oxygen tension (5%) in benchtop incubators.
16134090|NCT01904006|Procedure|Standard Culture Condition|Control group embryos cultured individually (1 embryo per drop) under atmospheric oxygen tension (20%) in large-box incubators.
16134091|NCT01903993|Drug|Docetaxel|Participants received starting dose of 75 mg/m^2 every three week (q3w) until disease progression, unacceptable toxicity or death. Dose modifications were according to the locally approved label. Participants randomized to receive docetaxel had to be premedicated with corticosteroids according to local practice.
16134092|NCT01903993|Drug|Atezolizumab|Participants received atezolizumab of 1200 mg (equivalent to an average body weight-based dose of 15 milligram per kilogram [mg/kg]) which was administered by IV infusion q3w on Day 1 of each 21 day cycle. Participants were allowed to continue treatment beyond progression per response evaluation criteria in solid tumors (RECIST) v1.1 if they were experiencing clinical benefit per investigator, did not have a decline in performance status, did not have signs or symptoms of unequivocal progression, did not have tumor progression at critical sites, and signed an informed consent signature page acknowledging deferment any standard treatment options that may exist in favor of continuing atezolizumab.
16134093|NCT01903980|Other|No intervention. It is a retrospective study|No intervention. It is a retrospective study
16134094|NCT01903954|Drug|peginterferon alfa-2a [Pegasys]|180 mcg sc weekly
16134095|NCT01903954|Drug|placebo|Orally b.i.d.
16134096|NCT01903954|Drug|ribavirin [Copegus]|1000 mg or 1200 mg orally daily
16134097|NCT01903954|Drug|setrobuvir|Loading dose of 800 mg orally b.i.d on Day 1, followed by 200 mg orally b.i.d., 28 or 48 weeks
16134098|NCT01903941|Behavioral|Aerobic Exercise|
16134099|NCT01903941|Behavioral|Only Counseling|
16134100|NCT01903928|Biological|ASP0113|injection
16134101|NCT01903902|Device|SeQuent® Please Drug-eluting balloon|Balloon angioplasty using paclitaxel-eluting balloon (SeQuent® Please) will be done in native small coronary artery (vessel diameter ≥ 2.25 mm and ≤ 2.75 mm, and lesion length < 25 mm), if residual stenosis is ≤ 30% and there are no dissection of classification C and over which disturbed blood flow after plain balloon angioplasty.
16134102|NCT01903889|Other|clinic based intervention|counseling C&T clients on FP; offering condoms, pills and injectables; and referring clients for other FP methods
16134103|NCT01903889|Other|clinic and community based intervention|basic intervention is introduced along with an intervention for constructive male engagement in HIV and FP services
16134104|NCT01903876|Behavioral|Bystander & Sexual Violence Prevention|This 3-hour web-based program consists of six 30-minute modules that are interactive and range in number of segments (1-14) and types of activities. Each of the modules involves interactivity, didactic activities and two episodes of a serial drama, which allows for the modeling of positive behaviors and illustrate both positive and negative outcome expectations for intervening and for perpetrating abuse against women. Behaviors modeled include communicating with female sex partners, obtaining informed consent to have sex, and intervening to prevent abuse from taking place.
16134105|NCT01903876|Behavioral|General Health Promotion|This general health promotion web-based program is 3-hours and provides a range of activities related to reducing day-to day stress and alleviating anxiety through meditation and exercise.
16134106|NCT01903863|Biological|Fresh frozen plasma|Fresh frozen plasma is a pooled blood product containing both pro and anticoagulation factors. Patients enrolled in the intervention arm will receive scheduled fresh frozen plasma treatment every 48 hours. Patients in the control arm will receive fresh frozen plasma per current institutional standard of care. This includes supplementation for clotting/bleeding diatheses, volume replacement, or after 3 red blood cell transfusions in a 24 hour period.
16134107|NCT01903850|Device|spray cryotherapy|spray cryotherapy
16134108|NCT01903837|Drug|Samidorphan (Low Dose)|Tablets taken once daily
16134109|NCT01903837|Drug|Samidorphan (Medium Dose)|Tablets taken once daily
16134110|NCT01903837|Drug|Samidorphan (High Dose)|Tablets taken once daily
16134111|NCT01903837|Drug|Placebo|Tablets taken once daily
16134112|NCT01903837|Drug|Olanzapine|Tablets taken once daily
16134113|NCT01903824|Drug|CEP-26401|CEP-26401 as an oral solution at the assigned dose of 5, 25 and/or 125 μg.
16134114|NCT01903824|Drug|donepezil hydrochloride|Donepezil hydrochloride, two 5 mg tablets, each over-encapsulated
16134115|NCT01903824|Drug|modafinil|modafinil 200 mg tablet, over-encapsulated
16134116|NCT01903824|Drug|Placebo|Placebos formulated to match each active drug
16134117|NCT01903811|Drug|Carfilzomib|Given IV
16134118|NCT01903811|Drug|Dexamethasone|Given IV
16134119|NCT01903811|Other|Laboratory Biomarker Analysis|Correlative studies
16134120|NCT01903798|Drug|Mycophenolate mofetil|Immunosuppressive agent
16134121|NCT01903798|Drug|Prednisolone|Corticosteroid
16134122|NCT01903798|Drug|Rilonacept|
16134124|NCT01903785|Drug|Placebo|
16134125|NCT01903772|Other|Inspiratory Muscle Training|
16134128|NCT01903720|Drug|dexamethasone implant|OZURDEX® (700 µg dexamethasone implant) administered intravitreally on day 0, and approximately every 4 months as needed (based on physician judgment) for up to 12 months.
16134129|NCT01903707|Other|Cognitive Remediation Therapy|Computerised training undertaken for approximately 30 minutes per day, 5 days per week for 8 weeks
16134130|NCT01903707|Other|Placebo comparator|Participant meets the therapist once per week but does not carry out the CRT intervention. (Participants are subsequently offered the chance to carry out the CRT intervention post study if they so wish).
16134131|NCT01903694|Drug|Sorafenib + Pravastatin|
16134132|NCT01903694|Drug|Sorafenib|
16134133|NCT01903681|Drug|Circadin 2 mg|First arm lower dose
16134134|NCT01903681|Drug|Circadin 10 mg|Second arm higher dose
16134135|NCT01903655|Other|telomere length|
16134136|NCT01903642|Other|proteomic analysis|
16134137|NCT01903629|Device|MCE|MCE first, followed by standard gastroscopy
16134138|NCT01903629|Device|Standard gastroscopy|
16134139|NCT01903590|Procedure|TVT surgery TOT surgery|
16134140|NCT01903577|Other|Robotic Task Performance|Subjects will perform FLS tasks on the robotic platform while EMG data is being collected. Task performance and NASA task load index will be assessed. Experts in robotic surgery will also perform operative cases while EMG is being collected.
16134141|NCT01903577|Other|Laparoscopic Task Performance|Subjects will perform FLS tasks on the laparoscopic platform while EMG data is being collected. Task performance and NASA task load index will be assessed. Experts in laparoscopic surgery will also perform operative cases while EMG is being collected.
16134142|NCT01903564|Device|magnetocardiography|recording of magnetic heart activity
16134143|NCT01903564|Device|postnatal ECG|postnatal ECG
16134144|NCT01903564|Device|fetal echocardiography|fetal echocardiography
16134145|NCT01903551|Device|Loco-regional catheter|it is an intra-fascial catheter for realing of the drug locally
16134146|NCT01903538|Device|Cathodal transcranial direct current stimulation (tDCS)|Cathodal transcranial direct current stimulation (tDCS) 20min, 1mA, F3 (EEG 10/20), reference right M. deltoideus
16134147|NCT01903538|Device|Sham transcranial direct current stimulation|Sham transcranial direct current stimulation (tDCS) 40s, 1mA, F3 (EEG 10/20), reference right M. deltoideus
16134148|NCT01903525|Drug|Docosahexaenoic acid (DHA)|Subjects presenting with a new concussion within 4 days of their initial injury will be identified and screened for eligibility from the investigators' regularly scheduled clinic patients. Subjects who enroll will complete 5 scheduled visits, although additional visits may be clinically indicated for symptom evaluation and treatment. All assessments done for this study are routinely done as part of the standard clinic visits for concussion at the Sports Medicine Center. Subjects will be randomized to either DHA or placebo in a 1:1 ratio, and receive enough DHA or placebo capsules to reach the target dose of 2 g of DHA per day (or placebo) until the day of their next appointment. Subjects will be instructed to take 4 capsules (2 at breakfast and 2 at dinner) for 12 weeks.
16134149|NCT01903525|Drug|Placebo|Subjects presenting with a new concussion within 4 days of their initial injury will be identified and screened for eligibility from the investigators' regularly scheduled clinic patients. Subjects who enroll will complete 5 scheduled visits, although additional visits may be clinically indicated for symptom evaluation and treatment. All assessments done for this study are routinely done as part of the standard clinic visits for concussion at the Sports Medicine Center. Subjects will be randomized to either DHA or placebo in a 1:1 ratio, and receive enough DHA or placebo capsules to reach the target dose of 2 g of DHA per day (or placebo) until the day of their next appointment. Subjects will be instructed to take 4 capsules (2 at breakfast and 2 at dinner) for 12 weeks.
16134150|NCT01903512|Procedure|TMJ arthrocentesis|lavage of the superior TMJ space with saline and sodium hyaluronate (SH)
16134151|NCT01903499|Other|Other: Bean patty|
16134152|NCT01903499|Other|Other: Beef patty|
16134153|NCT01903486|Drug|Apo-Prednisone Cordorol, Detasone - Prednisone|Oral prednisone (study medication) at a dose of 40mg for 1 week, then 30mg for 1 week, then 20mg for 1 week, then 10mg for 1 week, and then stop the medication.
16134154|NCT01903473|Drug|Rapamycin|"Rapamycin will be started within 2 weeks after inclusion. Rapamycin will be given at 2-6 mg loading dose for one day, followed by approximately 1 mg daily to achieve a target trough level of 5 to 10 ng/mL. The frequency of trough level measurements will be done according to the investigator choice; Rapamycin may be discontinued in case of resolution of chronic GVHD ≥ 3 months or in case of un-manageable side effects or progression of chronic GVHD.
~Calcineurin inhibitor discontinuation within 2 weeks after rapamycin initiation. No other modification of immunosuppressive drugs and in particular no decrease in the dose of steroids (unless necessary for side effects)."
16134155|NCT01903473|Other|T regulatory cells|"One infusion of ≥ 0.5 x10E6 T reg cells/kg recipient at 60-90 days after first day of rapamycin administration and after calcineurin inhibitor discontinuation. The infusion procedure will take one hour.
~Low-dose Il-2 (1x106 IU/day) will be started the day of DTI and will be continued for a period of 2months in order to expand infused donor Tregs."
16134156|NCT01903460|Drug|LUM001|
16134157|NCT01903460|Drug|Placebo|
16134158|NCT01903447|Drug|SSRI|
16134159|NCT01903447|Behavioral|CBT|
16134160|NCT01903434|Drug|Evacetrapib|Administered orally
16134161|NCT01903421|Drug|Spinal anesthesia group: bupivacaine 10-15mg|
16134162|NCT01903421|Drug|General anesthesia group: induction propofol 1.5-2mg/kg and fentanyl 1-3g/kg, maintained with isoflurane or sevoflurane|
16134163|NCT01903421|Genetic|Blood test|DNA will be tested for the presence of ε4 allele of the apolipoprotein E gene
16134164|NCT01903421|Other|Lumbar spinal tap|1ml of cerebrospinal fluid (CSF) removed and stored for further analysis of amyloid tau protein after completion of the study
16134165|NCT01903421|Behavioral|Montreal Cognitive Assessment (MOCA) and MMSE|
16134166|NCT01903408|Radiation|Intensity-modulated radiotherapy of the pelvic lymph nodes using SIB|The intervention is the use of modern radiation techniques with simultaneous integrated boost (SIB)
16134167|NCT01903395|Behavioral|Nurse-led counselling|Nurse-led telephone counselling to double the utilization of preventive colonoscopy
16134168|NCT01903369|Device|Shear Wave Elastography|Shear wave elastography
16134169|NCT01903356|Drug|Trajenta duo|Linagliptin and Metformin
16134170|NCT01903343|Device|shear wave elastography|ultrasound
16134173|NCT01903330|Drug|Cyclophosphamide|Given PO. Drug class: Alkylating Agent; Antineoplastic Agent; Nitrogen Mustard.
16134174|NCT01903330|Drug|Oral Control (Sucrose pill)|Given PO
16134175|NCT01903330|Drug|Injectable control (Sodium Chloride Injection United States Pharmacopeia (USP) (0.9%))|Given IV
16134176|NCT01903330|Drug|Bevacizumab/Bevacizumab Biosimilar|Given IV. Drug class: Immunological Agent; Monoclonal Antibody.
16134177|NCT01903317|Other|Topical Therapy|Subjects will continue use of topical therapy (e.g. topical corticosteroids, keratolytic agents, anthralin, coal tar, vitamin D analogs, retinoids) for their psoriasis as if they were not participating in this study.
16134178|NCT01903317|Other|Phototherapy and Systemic Therapy|Subjects will continue use of phototherapy (e.g. ultraviolet B [UVB] or ultraviolet A and psoralen [PUVA]) and systemic therapy (e.g. methotrexate, cyclosporine) for their psoriasis as if they were not participating in this study.
16134179|NCT01903317|Other|Biologic Therapy|Subjects will continue use of biologic therapy (e.g. etanercept, adalimumab, ustekinumab) for their psoriasis as if they were not participating in this study.
16134180|NCT01903304|Other|Olive Oil|3 months intervention
16134181|NCT01903291|Drug|dimethyl fumarate|As described in the treatment arm
16134182|NCT01903278|Drug|PEG-IFN-SA /RBV|
16134183|NCT01903278|Drug|Pegasys /RBV|
16134184|NCT01903265|Drug|TNX-102 SL 2.8mg|Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.
16134185|NCT01903265|Drug|Placebo|Patients will take 1 tablet of randomly assigned study drug sublingually each day at bedtime starting on Day 0 for 12 weeks.
16134186|NCT01903252|Drug|TP05|3.2g/day once daily for 12 weeks (blinded), 1.6g/d - 4.8g/d up to week 38 (open label)
16134187|NCT01903252|Drug|Asacol 400 mg|3.2g/d twice daily for 12 weeks (blinded), switch to 1.6g/ - 4.8g/d TP05 up to week 38 (open label)
16134188|NCT01903239|Procedure|Low-Risk BCC Excisional Margins|After the head and neck basal cell carcinomas satisfy the National Comprehensive clinical and histopathological criteria, all tumors are excised at the 2 mm margin.
16134189|NCT01903226|Other|High intensity training|
16134190|NCT01903226|Other|Moderate intensity training|
16134191|NCT01903213|Drug|bixalomer|Oral
16134192|NCT01903200|Drug|FK949E|Oral
16134193|NCT01903187|Device|EnligHTN Renal Denervation|Renal artery angiogram plus bilateral renal denervation with the EnligHTN renal denervation system
16134194|NCT01903187|Procedure|Sham|Renal artery angiogram
16134195|NCT01903174|Device|AeroForm Breast Tissue Expander|Breast Tissue Expander using a remote control to fill the expander with Carbon Dioxide
16134196|NCT01903161|Procedure|delayed remote ischemic preconditioning|In the delayed RIPC group, RIPC is performed 24-48 hr before surgery by 5 minutes limb ischemia and reperfusion with pneumatic cuff up to 200 mmHg repeated by four times.
16134197|NCT01903161|Procedure|control|In the control group, all the procedures were the same with delayed RIPC group, except for the fact that the three-way stopcock between the pneumatic cuff and the cuff inflator was opened and therefore the cuff pressure did not increase.
16134198|NCT01903135|Procedure|Blood test analysis in the clinical labs|for specific measurement of plasmatic bicarbonate
16134199|NCT01903135|Procedure|Pneumologist consult to establish the diagnosis of OHS|"complete respiratory check-up: Arterial blood gases analysis, spirometry, anthropometry, polygraphy or polysomnography.
~Medical history, previous treatments."
16134200|NCT01903122|Drug|Cevimeline|
16134201|NCT01903109|Drug|Cevimeline|
16134202|NCT01903096|Behavioral|Cognitive Behavioral Treatment|Seven ninety-minute sessions of evidence-based psychological techniques designed to treat anxiety, depression and somatization disorders during a period of 24 weeks.
16134203|NCT01903096|Drug|Primary Care Treatment As Usual|Usual treatment offered in Primary Care Services: depending on the diagnoses, patients will be prescribed different medications until symptoms disappear.
16134204|NCT01903083|Drug|Tadalafil|One 2.5 mg tablet is self-administered orally by the study participant on a once daily basis.
16134205|NCT01903083|Drug|Gemcitabine|Three doses of gemcitabine (1000 mg / m^2)are given over a 21-day cycle. Patients may receive up to 4 cycles.
16134206|NCT01903083|Radiation|Radiation|Patients will receive 3 doses of radiation (8-10 Gy per fraction).
16134207|NCT01903083|Procedure|Pancreaticoduodenectomy|Surgical resection.
16134208|NCT01903070|Drug|Linagliptin|
16134209|NCT01903057|Drug|azithromycin|
16134210|NCT01903057|Drug|ivermectin|
16134211|NCT01903057|Drug|albendazole|
16134212|NCT01903057|Drug|placebo|
16134213|NCT01903044|Procedure|BM-MNC injection|BM-MNC cells will be injected in aliquots of 1 ml at multiple regions of the leg muscles
16134214|NCT01903031|Device|Nuvaring|NuvaRing is made of ethylene vinylacetate copolymers (28% and 9% vinylacetate) and magnesium stearate, is latex free, and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. NuvaRing has an outer diameter of 54 mm and a cross-sectional diameter of 4mm. Once NuvaRing is inserted into the vagina, the ring should remain in place (not be removed) continuously for 3 weeks (21 days). After being in place for the first 21 days of the study, the ring may be removed after the day 21 study visit evaluations have been completed.
16134215|NCT01903031|Drug|EFV|Participants received EFV 600 mg daily with two or more NRTIs
16134216|NCT01903031|Drug|ATV/r|Participants received ATV/r 300 mg/ 100 mg daily with tenofovir and one or more additional NRTIs
16134217|NCT01903031|Drug|TDF|Participants received 300 mg of tenofovir in Arm C
16134218|NCT01903031|Drug|NRTIs|Participants received two or more NRTIs in Arm B and one or more NRTIs in Arm C
16134219|NCT01903018|Drug|P276-00|
16134220|NCT01903018|Radiation|Radiation Therapy|
16134221|NCT01903018|Drug|Cisplatin|
16134222|NCT01903005|Drug|Higher bioavailability BNX sublingual tablets|Once daily, open-label treatment with higher bioavailability BNX sublingual tablets for 24 weeks
16134223|NCT01902992|Drug|Depiquick Birch (DPG103)|
16134224|NCT01902992|Drug|Placebo|
16134225|NCT01902979|Behavioral|Lifestyle intervention|
16134226|NCT01902966|Drug|Propranolol|Starting dose: 20 mg is taken by mouth twice a day (40 mg/day).
16134227|NCT01902966|Behavioral|Diary|Patients record study medication taken each day in a pill diary. Relaxation diary completed after listening to audio sessions twice a week.
16134228|NCT01902966|Behavioral|Relaxation Audio Recording|Patient given an MP3 player with an audio recording to listen to 2 times a week for up to 4 months. The recording lasts 20 minutes.
16134229|NCT01902966|Behavioral|Questionnaires|Questionnaires completed at baseline, 2 months, and 4 months.
16134230|NCT01902953|Drug|Lymphoseek and VBD Sln dissection|See detailed description of study design
16134231|NCT01902940|Other|Natural History|Assessment of natural history in IBM and CCFDN
16134232|NCT01902927|Other|Attentional distraction using IAPS protocol (standardized images)|Positive, Negative and Neutral Attentional distraction will be presented using IAPS protocol (standardized images) during exercise tests
16134233|NCT01902914|Procedure|Hearing Aids Evaluation|Functional Gain Sound field Speech Audiometry
16134234|NCT01902901|Genetic|Whole Genome Sequencing|Participants will receive Whole Genome Sequencing
16134235|NCT01902901|Genetic|Carrier status testing|Carrier status testing
16134236|NCT01902888|Device|GORE® VIABAHN® Endoprosthesis|
16134237|NCT01902875|Drug|Paclitaxel + Cisplatin|Paclitaxel 135mg/m2, intravenous drip, D1; Cisplatin 75 mg/m2, intravenous drip, D1; Repeat for 4 weeks interval.
16134238|NCT01902875|Biological|CIK cell therapy|Peripheral blood mononuclear cell are separated before chemotherapy, and before each CIK cell transfusion. CIK cells are transfused on D7, D14, D21(with simultaneous transfusion of IL-2 2 million units).
16134239|NCT01902862|Drug|Bortezomib|Bortezomib will be administered as intravenous infusion as 1.6 milligram per meter square (mg per m^2) on Days 1, 8, 15 and 22 of cycle 1 and Days 36, 43, 50, 57 of cycle 2 and (if applicable) on Days 71, 78, 85, and 92 of Cycle 3.
16134240|NCT01902862|Drug|Rituximab|Rituximab will be administered as intravenous infusion as 375 mg pert m^2 on Days 36, 43, 50, 57 of cycle 2 and (if applicable) on Days 71, 78, 85, and 92 of Cycle 3.
16134241|NCT01902849|Other|blood sampling for IL measurement|"Blood sampling to determine interleukins IL6 , IL10 plasma levels are drawn at the following moments:
~T0- before the induction of anesthesia (venous cannula insertion time)
~T1- after induction but before starting surgery
~In the group I (TIVA -TCI) when the plasma concentration of propofol is 3-3.5 ng/ml
~In group II (ISOFLURANE) when concentration of isoflurane in exhaled air (Et Isoflurane) is between 0.3-0.5%
~T2, T3- at 2 and 24 hours after surgery"
16134242|NCT01902836|Biological|Conventional treatment plus DLE|"Paediatric patients with diagnosis of atopic dermatitis according to Hanifin and Rajka and evaluated with SCORAD as moderate atopic dermatitis were included. Patients were randomized and received in a double blind placebo-controlled treatment:
~Group 1: Conventional treatment plus DLE Conventional Treatment: oral Cetirizine 0.25mg/kg, every day, for 4 weeks; chlorpheniramine 0.35 mg/Kg, daily divided in 3 doses, for 4 weeks; and topical Methylprednisolone 0.1% over affected skin area, every 12h for 10 days, then every 24h for 10 days and then every 48h for 10 days and suspend; plus oral DLE (Transferon) (2mg/5mL), every day for 5 days, then every 72hrs to complete one month"
16134243|NCT01902836|Biological|Conventional treatment plus placebo|Group 2: Conventional treatment plus placebo. Conventional treatment: Cetirizine 0.25mg/kg oral, every day, for 4 weeks; chlorpheniramine 0.35 mg/Kg, daily divided in 3 doses, for 4 weeks; topical Methylprednisolone 0.1% over affected skin area, every 12h for 10 days, then every 24h for 10 days and then every 48h for 10 days and suspend; and oral placebo, every day for 5 days, then every 72hrs to complete one month.
16134244|NCT01902823|Behavioral|Services from a Nurse Navigator|Services from a Nurse Navigator
16134245|NCT01902810|Drug|Propranolol|Propranolol by mouth given daily throughout hospitalization
16134246|NCT01902810|Drug|Placebo|Placebo by mouth given daily throughout hospitalization
16134247|NCT01902797|Other|Questionnaire|Participants will be invited to complete questionnaires and those who are over 5 year of age will be asked to give blood samples.
16134248|NCT01902784|Behavioral|Storytelling Interview|
16134249|NCT01902771|Biological|Dendritic Cell Vaccine|Post-Leukapheresis. Subjects will receive DC Vaccine administered once weekly, via intradermal injection, for 4 weeks for a total of four vaccinations, per study protocol.
16134250|NCT01902771|Biological|Tumor Lysate|Post-DC Vaccine therapy. Up to 1.5 mg of Lysate of tumor per dose administered via intradermal injection at intervals defined by study protocol.
16134251|NCT01902771|Other|Imiquimod|Subjects will self-apply Imiquimod topically to each designated vaccine site before and after scheduled administrations of DC Vaccine or Lysate, per study protocol.
16134252|NCT01902771|Procedure|Leukapheresis|Baseline, post-surgery. Subjects will undergo leukapheresis procedure during baseline, after recovery from surgery to collect peripheral blood mononuclear cells (PBMCs) from which dendritic cells will be obtained, per study protocol.
16134253|NCT01902758|Drug|ambrisentan and theophylline|
16134254|NCT01902758|Drug|placebo|placebo for comparison group
16134255|NCT01902745|Behavioral|Social Cognitive Theory|Social Cognitive Theory of motivating participants to change their behaviors for overall health and well being.
16134256|NCT01902732|Device|Implantation of valves (IBV)|Implantation of intrabronchial valves in the most emphysematous destroyed and hyperinflated lung lobe improves the elastic recoisl of the samll airways by a reduction in lung volume and thus leading to more ergonomic breathing mechanics and diaphragm function. This positive effect is observed particularly in patients with low interlobar collateral ventilation that can be quantified by CT fissure analysis and/or catheter-based measurement.
16134257|NCT01902719|Behavioral|Community Health Worker (CHW) Intervention|Receipt of training in use of home blood pressure machine, education about diet, exercise and physical activities to lower blood pressure, and continued support from a trained community health worker.
16134258|NCT01902719|Behavioral|Communication Skills Training|"Receipt of Do My PART (P-Prepare for Visit, A- Act at visit, R-Review doctor's recommendations, T-Take home recommendations)communication skills training."
16134259|NCT01902719|Behavioral|Problem Solving Skills Training|Receipt of a 9-week group based self-management intervention designed to help patients identify and solve self-identified barriers to hypertension control.
16134260|NCT01902693|Other|No intervention for this study|No intervention
16134261|NCT01902680|Radiation|Focal brachytherapy|Focal brachytherapy with permanent I125 localized implant.
16134262|NCT01902667|Procedure|Magnetic Resonance Imaging|
16134263|NCT01902654|Other|Cardiovascular risk factors diagnoses collection.|We look over patient medical record and we collect the diagnoses associated with cardiovascular risk factor as hypertension, obesity, dislipidemia and diabetes.
16134264|NCT01902654|Other|History of cardiovascular disease|In all patient we collect the history of cardiovascular disease.
16134265|NCT01902654|Other|Cardiovascular risk factors association|We have defined two groups according to grouping of none, 1 or 2 cardiovascular risk factors or 3 or more.
16134266|NCT01902641|Drug|Succinylcholine|Anaesthesia was induced and maintained with propofol (1-2 mg/kg) and remifentanil (0.5 µg/kg). The study arm was immobilized and a dual electrode for peripheral nerve stimulation was placed over the ulnar nerve near the wrist. Neuromuscular monitoring was performed with accelerometry.The patients received succinycholine according to the study group.
16134267|NCT01902641|Drug|Rocuronium/Sugammadex|Anaesthesia was induced and maintained with propofol (1-2 mg/kg) and remifentanil (0.5 µg/kg). The study arm was immobilized and a dual electrode for peripheral nerve stimulation was placed over the ulnar nerve near the wrist. Neuromuscular monitoring was performed with accelerometry.The patients received rocuronium/sugammadex according to the study group.
16134268|NCT01902641|Drug|Rocuronium|Anaesthesia was induced and maintained with propofol (1-2 mg/kg) and remifentanil (0.5 µg/kg). The study arm was immobilized and a dual electrode for peripheral nerve stimulation was placed over the ulnar nerve near the wrist. Neuromuscular monitoring was performed with accelerometry.The patients received rocuronium according to the study group.
16134269|NCT01902589|Other|Helicobacter Pylori Culture|"Biopsy specimens for histology will be fixed in formalin, embedded in paraffin and sectioned and stained with hematoxylin and eosin.
~The microbiological workup will include an imprint of the biopsy on a slide followed by a gram stain for the purpose of demonstrating H. pylori in situ. Further the biopsies will be streaked out on chocolate agar, Sheep blood agar and H. pylori selective agar supplemented with Polymixin to suppress possible contaminants.
~4 days of incubation in a micro aerophilic atmosphere will follow . Susceptibility testing of H pylori will be performed with E test on Mueller Hinton agar supplemented with defibrinated sheep blood using a MacFalrland 3.0 density of a bacterial suspension. Reading the susceptibility will take place following 72 hours of incubation in a micro aerophilic atmosphere."
16134270|NCT01902563|Other|Osteopathic Manipulative Treatment|
16134271|NCT01902550|Drug|Metoprolol tartrate immediate-release (metoprolol IR)|Metoprolol IR will be administered as single oral dose of 100 mg tablet or capsule.
16134272|NCT01902550|Drug|JNJ-54452840|JNJ-54452840 (12 ml solution containing 240 mg JNJ-54452840) will be administered intravenously over 1 minute.
16134273|NCT01902550|Drug|Placebo|Matching Placebo (normal saline) to JNJ-54452840 will be administered intravenously over 1 minute on Day 1.
16134274|NCT01902537|Drug|Prucalopride; observational study|This is an observational study. Korean female participants with chronic constipation and having received treatment previously will be assessed for the health related QoL.
16134275|NCT01902524|Drug|Fentanyl-TTS|All of the participants will receive the study drug at least once transdermally, administration dosage starts at 12.5 microgram/hour.
16134276|NCT01902511|Drug|G-CSF+Erythropoetin|
16134277|NCT01902511|Drug|G-CSF|
16134278|NCT01902498|Drug|Aspirin|Aspirin 81mg po daily x 7days or end of hospitalization. First dose administered on post op day 1.
16134279|NCT01902498|Drug|Aspirin|Aspirin 325mg po daily x 7days or end of hospitalization. First dose administered on post op day 1.
16134280|NCT01902498|Drug|Aspirin|Aspirin 162mg po twice daily x 7days or end of hospitalization. First dose administered on post op day 1.
16134281|NCT01902485|Other|Timing of Contraceptive Initiation in Medical Abortion|
16134282|NCT01902459|Biological|EVARREST™ Fibrin Sealant Patch|EVARREST™ Fibrin Sealant Patch is a sterile, bio-absorbable combination product, comprised of two biological components (human plasma-derived fibrinogen and thrombin) embedded in a flexible composite patch component.
16134283|NCT01902459|Other|Standard of Care|Standard of Care will be manual compression (MC) with or without a topical absorbable hemostat (TAH) or any other adjunctive hemostasis technique that is deemed by the surgeon to be his/her standard of care.
16134284|NCT01902446|Drug|Chlorhexidine gluconate|Study solution will be applied to the oropharynx and will be distributed for 15 seconds with a swab stick. No suction will be applied for at least 30 seconds.
16134285|NCT01902433|Procedure|Astym|
16134286|NCT01902394|Other|Whole grains|Following completion of the baseline period (a 2-week run-in phase), participants in the WG group will receive a diet providing 100% of energy requirements in a diet rich in whole grains and the RG group will be provided with 100% of energy requirements in a diet rich in refined grains but otherwise similar to the WG diet for 6 weeks.
16134287|NCT01902394|Other|Refined grains|Following completion of the baseline period (a 2-week run-in phase), participants in the WG group will receive a diet providing 100% of energy requirements in a diet rich in whole grains and the RG group will be provided with 100% of energy requirements in a diet rich in refined grains but otherwise similar to the WG diet for 6 weeks.
16134288|NCT01902381|Drug|6,8-bis(benzylthio)octanoic acid|Given IV
16134289|NCT01902368|Other|gluten free diet|
16134290|NCT01902355|Procedure|modified Seldinger technique|modified Seldinger technique(guiding sheath-over-the-needle technique) use needle that is covered with guiding sheath. After desired vessel puncture, guiding sheath is instantly slid over the needle into the vessel. The needle is withdrawn, guidewire is advanced through the guiding sheath, central catheter is placed into the vessel.
16134291|NCT01902355|Procedure|Seldinger technique|The desired vessel is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn. Central catheter is then passed over the guidewire into the vessel.
16134292|NCT01902342|Drug|Oseltamivir 75 mg 1 cap|
16134293|NCT01902329|Drug|HMA|azacitidine 75 mg/m2 for 7 days or decitabine 20mg/m2 for 5 days
16134294|NCT01902329|Drug|SGN-CD33A|Given intravenously on Day 1 or Days 1 and 4 every 3 weeks (SGN-CD33A Monotherapy) or given intravenously on the final HMA dosing day every 4 weeks (SGN-CD33A+HMA)
16134295|NCT01902303|Drug|Matching Placebo|Sublingual micro dosing of placebo for 7 days
16134296|NCT01902303|Drug|BTL-TML-HSV|Sublingual micro dosing of BTL-TML-HSV for 7 days
16134297|NCT01902290|Biological|Placebo|Placebo administered SC
16134298|NCT01902290|Biological|210 mg brodalumab|210 mg brodalumab administered SC
16134299|NCT01902264|Drug|EE20/DRSP/L-5-MTHF (Beyaz, BAY98-7071)|One tablet DRSP 3 mg/EE 0.02 mg/ Levomefolate calcium 0.451 mg daily for 24 days, followed by one hormone-free tablet L-5-MTHF 0.451 mg daily for 4 days over 24 weeks
16134301|NCT01902251|Drug|Enzalutamide capsule|Oral
16134302|NCT01902238|Procedure|EUS-guided ethanol-lipiodol mixture ablation|By using 3D-volumetric analysis, the optimal volume of ethanol/lipiodol (1:1 mixture) is calculated by computer estimation of areas on each axial image, using EUS software permitting volume calculation. After calculating optimal ethanol volume by 3D volumetric analysis, we advance the needle into the tumor and inject estimated volume of ethanol, typically 1 to 1.5 ml.
16134303|NCT01902225|Drug|Istodax|
16134304|NCT01902225|Drug|Doxil|
16134305|NCT01902212|Other|Oral Nutritional Supplement|
16134306|NCT01902199|Behavioral|TRAA intervention|The Tobacco Retraining of Automatic Approach The tobacco-RAA will be the intervention in changing approach tendencies towards tobacco. The task uses pictures of tobacco related objects (e.g, a cigarette) and pictures of non-tobacco related objects (e.g, a spoon). Patients will be presented with a joystick while pictures are presented on a computer screen. Patients will be presented with pictures, pulling pictures in a portrait format, while they push pictures in a landscape format. In the experimental condition pictures pushed will almost exclusively be smoking related pictures. In the control condition smoking pictures will be equally divided into push and pull conditions.
16134307|NCT01902186|Drug|raltegravir and atazanavir and ritonavir|switch tenofovir/emtricitabine to raltegravir
16134308|NCT01902186|Drug|tenofovir/emtricitabine and atazanavir and ritonavir|no change in antiretroviral treatment; patients will continue their regimen (tenofovir/emtricitabine and atazanavir and ritonavir)
16134309|NCT01902173|Drug|Dabrafenib Mesylate|Given PO
16134310|NCT01902173|Drug|Trametinib Dimethyl Sulfoxide|Given PO
16134311|NCT01902173|Drug|Uprosertib|Given PO
16134312|NCT01902160|Drug|Brentuximab Vedotin|Given IV
16134313|NCT01902160|Other|Laboratory Biomarker Analysis|Correlative studies
16134314|NCT01902160|Drug|Temsirolimus|Given IV
16134315|NCT01902147|Other|Postoperative Quality Recovery Scale (PQRS)|The PQRS is completed prior to surgery to provide baseline values, and then repeated at different intervals: 15 minutes, 40 minutes, 1 and 3 days, and 4-8 weeks after the completion of surgery. Recovery is broadly defined as return to baseline or better.
16134316|NCT01902134|Drug|Placebo|Placebo single oral dose (first 8 hours)
16134317|NCT01902134|Drug|Tramadol-single dose|Tramadol single oral dose (first 8 hours)
16134318|NCT01902134|Drug|Dexketoprofen-single dose|Dexketoprofen single oral dose (first 8 hours)
16134319|NCT01902134|Drug|Dexketoprofen/Tramadol-single dose|Dexketoprofen/Tramadol oral single dose (first 8 hours)
16134320|NCT01902134|Drug|Tramadol-multiple doses|Tramadol multiple oral doses t.i.d. for 5 days (total 12 doses)
16134321|NCT01902134|Drug|Dexketoprofen-multiple doses|Dexketoprofen multiple oral doses t.i.d. for 5 days (total 12 doses)
16134322|NCT01902134|Drug|Dexketoprofen/Tramadol-multiple doses|Dexketoprofen/Tramadol multiple oral doses t.i.d. for 5 days (total 12 doses)
16134323|NCT01902121|Drug|Technosphere® Insulin 10U + 20U|Inhaled Insulin
16134324|NCT01902121|Drug|Technosphere® Insulin 30U|Inhaled Insulin
16134325|NCT01902108|Drug|Bupivacaine|Local infiltration before wound incision with 20 ml of Bupivacaine 0.25 % alone
16134326|NCT01902108|Drug|Clonidine|Clonidine 150μg locally infiltrated with 20 ml of bupivacaine 0.25 % before wound incision
16134327|NCT01902095|Device|Tooth powder|Each participant was handed over a sealed pack containing a teeth cleaning kit that included tooth powder (test) or toothpaste (control) and a new soft toothbrush along with written and verbal instructions of usage. They were advised to brush their teeth twice a day with the given dentifrices and tooth brush for two weeks.
16134328|NCT01902095|Device|Tooth paste (control)|Active Comparator
16134329|NCT01902082|Drug|Mesenchymal stem cells|
16134330|NCT01902082|Drug|Placebo|
16134331|NCT01902069|Dietary Supplement|Phospholean|"Phospholean supplied by Cheminutra (White Bear Lake, MN). PhosphoLean® N-Oleoyl-PE + EGCG (NOPE + EGCG) is a proprietary phosphobioflavonic complex of N-oleoyl-phosphatidyl-ethanolamine (NOPE), which contains oleoyl ethanolamine (OEA) bound to phosphatidylethanolamine (PE), and epigallocatechin gallate (EGCG).
~PhosphoLean® 40P is a dietary ingredient under the Dietary Supplement Health and Education Act (DSHEA) regulations of the US FDA (1994)."
16134332|NCT01902069|Dietary Supplement|Placebo|Placebo consists of rice flour
16134333|NCT01902056|Procedure|One layer allograft|The acellular dermal matrix was placed on the facial surface.
16134334|NCT01902056|Procedure|Two layer allograft|The acellular dermal matrix was placed on the facial surface.
16134335|NCT01902017|Drug|Ketotifen|5 mg PO bid
16134336|NCT01902017|Drug|Placebo|5 mg placebo PO bid
16134337|NCT01902004|Drug|Escitalopram|All subjects will receive 10 to 20mg of escitalopram open-label throughout the trial. Participants will begin taking one 10mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of escitalopram until treatment completion.
16134338|NCT01902004|Drug|Memantine|Memantine dosage will be 5 to 20mg a day. Participants will initially take one 5mg capsule once a day, which will be gradually increased to a maximum of 10mg capsules twice per day.
16134339|NCT01902004|Drug|Placebo|Placebo pills will be taken in combination with the active Namenda (Memantine) pills. Participants will initially take 1 capsule per day, which will be increased to a maximum of 1 capsule twice per day.
16134340|NCT01901991|Procedure|Radioactive seed localization (RSL)|Localization of nonpalpable breast lesions with Radioactive seed localization
16134341|NCT01901991|Procedure|Wire-guided localization (WGL)|Localization of nonpalpable breast lesions with Wire-guided localization
16134342|NCT01901978|Behavioral|Caloric restrictive diet|Patients will meet weekly with a registered dietician.
16134343|NCT01901965|Behavioral|Neuromuscular electrical stimulation|
16134344|NCT01901965|Behavioral|eccentric training|
16134345|NCT01901952|Behavioral|Intensive education and lifestyle support|Group classes for 12 months (weekly for 4 months, biweekly for 4 months, monthly for 4 months), weekly peer supporter telephone calls, and diabetes education newsletters every 2 months.
16134346|NCT01901952|Behavioral|Standard of Care control group|Participants receive 2 diabetes education classes taught by a Certified Diabetes Educator. They also receive diabetes education newsletters every 2 months.
16134347|NCT01901939|Other|exercise|daily tailored low level pedaling exercise at bedside
16134348|NCT01901926|Procedure|Non Surgical Periodontal Treatment|one time intervention in the form of scaling and root planing
16134349|NCT01901913|Device|MD-bolus calculator for pre-meal bolus|
16134350|NCT01901913|Device|No MD-bolus calculator for pre-meal bolus|
16134351|NCT01901887|Drug|Study Juice|The intervention will be 3 boxes/day for 6 months of SMARTFISH® Nutrifriend 1100, a commercially available smoothie juice box containing 1,100 mg of omega-3 HUFAs/200 ml box (approximately 550 mg EPA and 550 mg DHA/box) for a total of 3,300 mg of omega-3 HUFAs/day (approximately 1,650 mg EPA and 1,650 mg DHA/day).
16134352|NCT01901887|Drug|Placebo Juice|The placebo will be 3 boxes/day for 6 months of a placebo juice which will be identical to the study juice except that it will substitute 1,100 mg of macadamia nut oil/200 ml juice box in place of the omega-3 HUFAs for a total of 3,300 mg of macadamia nut oil/day.
16134353|NCT01901874|Device|Carotid Artery Stenting|Carotid Artery Stenting with the GORE® Carotid Stent
16134354|NCT01901861|Drug|Sitagliptin|Sitagliptin 100mg is given before meal ingestion
16134355|NCT01901861|Drug|Placebo|Placebo is given before meal ingestion
16134356|NCT01901848|Behavioral|Cognitive Processing Therapy (CPT)|CPT is based on a social cognitive theory of PTSD that includes primary emotional responses to traumatic events such as fear, anger, and sadness, as well as secondary emotions resulting from a patient's faulty interpretations of the traumatic event. CPT addresses PTSD by facilitating affective expression so that affective components of the trauma memory can be altered. In addition, faulty beliefs about the trauma are challenged and modified using Socratic questioning.
16134357|NCT01901848|Drug|Bupropion|Bupropion is an anti-depressant medication that is commonly used in smoking cessation treatment.
16134358|NCT01901848|Drug|nicotine replacement therapy (NRT)|NRT in the form of nicotine patches and an NRT rescue method (e.g., nicotine gum, lozenge, inhaler) will be prescribed for participants for use on/after quit date.
16134359|NCT01901848|Behavioral|Integrated Care for Smoking Cessation (ICSC)|ICSC is a manualized treatment for smoking cessation involving six sessions of counseling.
16134360|NCT01901848|Behavioral|smokefreeVET|SmokefreeVET is a program that was developed by the National Institutes of Health and Department of Veterans Affairs. The program includes a text messaging protocol for reaching out to Veterans who wish to stop smoking.
16134361|NCT01901835|Procedure|mind-body intervention procedure|Participate in media diversion with humorous and non-humorous movies
16134362|NCT01901835|Other|survey administration|Ancillary studies
16134363|NCT01901835|Procedure|quality-of-life assessment|Ancillary studies
16134364|NCT01901822|Procedure|Sutured together|The soft tissue and the allograft will be sutured together using a continuous sling suture.
16134365|NCT01901822|Procedure|Sutured separately|The soft tissue and the allograft will be sutured separately using a continuous sling suture.
16134366|NCT01901809|Drug|Furosemide|
16134367|NCT01901809|Drug|Dopamine|
16134368|NCT01901796|Behavioral|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy- an effective, non-pharmacological treatment for depression and anxiety.
16134369|NCT01901783|Procedure|With primary closure|A cancellous block allograft will be placed for ridge augmentation and covered with a barrier membrane. The soft tissue will be primarily closed over the membrane.
16134370|NCT01901783|Procedure|Without primary closure|A cancellous block allograft will be placed for ridge augmentation and covered with a barrier membrane. The soft tissue will not be primarily closed over the membrane.
16134371|NCT01901770|Other|educational intervention|Receive HPV vaccination educational materials
16134372|NCT01901770|Other|educational intervention|Receive influenza vaccination educational materials
16134373|NCT01901757|Drug|HCP1201, Fasted followed by fed|There are 2 administration periods with 7 days of wash-out. In period 1, the subjects will receive a single oral dose of HCP1201 under fasted condition. In period 2, the subjects will receive a single oral dose of HCP1201 under fed condition.
16134374|NCT01901757|Drug|HCP1201, Fed followed by fasted|There are 2 administration periods with 7 days of wash-out. In period 1, the subjects will receive a single oral dose of HCP1201 under fed condition. In period 2, the subjects will receive a single oral dose of HCP1201 under fasted condition.
16134375|NCT01901744|Procedure|Cataract Surgery|
16134376|NCT01901731|Procedure|transjugular coil embolisation of pelvic veins|
16134377|NCT01901731|Procedure|endovenous treatment of leg varicose veins|
16134378|NCT01901705|Drug|Indigo naturalis ointment|The Indigo naturalis ointment was composed of a 1:10 mixture of Indigo naturalis powder and a vehicle consisting of Vaseline: microcrystalline wax: olive oil (5:6:9 ratio)
16134379|NCT01901705|Drug|Placebo|The placebo was a mixture of blue dye powder (54.8% Indigo carmine aluminum lake [Blue #32] and 45.2% Allura Red AC aluminum lake [Red #40] powders), Vaseline, microcrystalline wax, and olive oil.
16134380|NCT01901692|Radiation|TACE+External beam RT|Trans-arterial chemoembolization (TACE) every 6 weeks + external beam radiation therapy starting within 3 weeks after first TACE
16134381|NCT01901692|Drug|Sorafenib|Sorafenib 800 mg/day orally
16134382|NCT01901679|Drug|Celebrex|200 mg PO BID
16134383|NCT01901666|Drug|Growth Hormone|"All GH deficient patients with bone age <14 years will be treated with GH therapy for one year.Serum IGF-1 will be measured 4weekly and GH dose will be titrated till S.IGF-1 is in mid-normal range and then after every 3 months.
~Growth parameters will be assessed after every 3 months.Serum T4, TSH will be done after every 3 months. Patients will be monitored for any side effects of GH therapy"
16134384|NCT01901653|Drug|Rovalpituzumab tesirine (SC16LD6.5)|
16134385|NCT01901640|Drug|DA-8159 (Udenafil)|
16134386|NCT01901614|Procedure|LALAK|"A dovetail shaped cut will be made on the graft using a femtosecond laser at the eye bank. The cut depth will be proportional to the central stromal thickness of the graft. This graft will be separated from stromal bed by eye bank personnel for examination of the cut surface. High-quality graft will be replaced in preservation medium and shipped to the surgeon prior to surgery.
~The host cornea will receive femtosecond laser cut consisting of a shallow lamellar cut with angled side cut to match the dovetail graft in a tongue-in-groove fashion. The femtosecond laser treatments will be performed under topical anesthesia in the laser suite. The femtosecond laser is an FDA-approved device for use in this indication (corneal transplantation including lamellar keratoplasty). A protective eye shield is placed over the eye. The graft will be sutured into the host bed."
16134521|NCT01900730|Behavioral|Questionnaires|Questionnaires completed at baseline, weeks 2, 6, and 10.
16134387|NCT01901614|Procedure|IEK|"A full thickness graft will be prepared at the eye bank with zigzag side cuts prepared with a femtosecond laser. The graft is separated from the rim, replaced in the preservation medium, and shipped to the surgeon prior to the surgery.
~In the laser suite, the host cornea will be cut with the femtosecond laser with zigzag side cuts leaving a 70-100 micron bridge. A protective eye shield is placed over the eye. The graft will be sutured into the host bed."
16134388|NCT01901614|Drug|Retrobulbar Block or General Anesthesia|
16134389|NCT01901614|Device|optical coherence tomography (OCT)|OCT will be used to guide the depth of the graft and donor dissections.
16134390|NCT01901614|Drug|Topical Anesthesia|
16134391|NCT01901614|Device|femtosecond laser|The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA). The iFS is FDA-approved for corneal surgery including full thickness and lamellar keratoplasty. Eye banks use earlier versions of the Intralase system which are also FDA approved for this indication.
16134392|NCT01901601|Procedure|LALAK|"A dovetail shaped cut will be made on the graft using a femtosecond laser at the eye bank. The cut depth will be proportional to the central stromal thickness of the graft. This graft will be separated from stromal bed by eye bank personnel for examination of the cut surface. High-quality graft will be replaced in preservation medium and shipped to the surgeon prior to surgery.
~The host cornea will receive femtosecond laser cut consisting of a shallow lamellar cut with angled side cut to match the dovetail graft in a tongue-in-groove fashion. The femtosecond laser treatments will be performed under topical anesthesia in the laser suite. The femtosecond laser is an FDA-approved device for use in this indication (corneal transplantation including lamellar keratoplasty). A protective eye shield is placed over the eye. The graft will be sutured into the host bed."
16134393|NCT01901601|Procedure|IEK|"A full thickness graft will be prepared at the eye bank with zigzag side cuts prepared with a femtosecond laser. The graft is separated from the rim, replaced in the preservation medium, and shipped to the surgeon prior to the surgery.
~In the laser suite, the host cornea will be cut with the femtosecond laser with zigzag side cuts leaving a 70-100 micron bridge. A protective eye shield is placed over the eye. The graft will be sutured into the host bed."
16134394|NCT01901601|Drug|Retrobulbar Block or General Anesthesia|
16134395|NCT01901601|Device|optical coherence tomography (OCT)|OCT will be used to guide the depth of the graft and donor dissections. The OCT systems to be used in this study will be the RTVue (Optovue, Inc., Fremont, CA) or the Visante (Carl Zeiss Meditec, Inc., Dublin, CA). Both are FDA-approved for the mapping of corneal thickness.
16134396|NCT01901601|Drug|Topical Anesthesia|
16134397|NCT01901601|Device|femtosecond laser|The femtosecond laser system to be used in this study for host cornea preparation will be the Intralase FS system (iFS, AMO, Inc., Santa Ana, CA). The iFS is FDA-approved for corneal surgery including full thickness and lamellar keratoplasty. Eye banks use earlier versions of the Intralase system which are also FDA approved for this indication.
16134398|NCT01901588|Drug|Dexmedetomidine|intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes
16134399|NCT01901588|Other|Placebo|intraoperative dose of intravenous placebo
16134400|NCT01901575|Drug|Remifentanil|Patients with established PVC's , sedated with remifentanil IVPCA per study protocol
16134401|NCT01901562|Device|Ductoscopic papillomectomy|Intraductal papilloma extraction through the nipple orifice by interventional ductoscopy
16134402|NCT01901549|Procedure|Renal denervation|The treatment catheter is introduced into each renal artery and is applied discrete, radiofrequency ablations lasting up to 2 min each and of 8 watts or less to obtain up to six ablations separated both longitudinally and rotationally within each renal artery. During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm. After the procedure the control arterial angiogram should be done.
16134403|NCT01901549|Drug|Metoprolol|Beta-blockers. Optimal mediсal therapy will be assigned according to ACS and STE guidelines.
16134404|NCT01901549|Drug|Lisinopril|ACE inhibitors. Optimal mediсal therapy will be assigned according to ACS and STE guidelines.
16134405|NCT01901536|Behavioral|Family Foundations Coparenting Program|"Family Foundations, a program for adult couples expecting their first child, is designed to help them establish positive parenting skills and adjust to the physical, social, and emotional challenges of parenthood. Program topics include coping with postpartum depression and stress, creating a caring environment, and developing the child's social and emotional competence.
~Family Foundations is delivered to groups of couples through four prenatal and four postnatal classes of 2 hours each. Prenatal classes are started during the fifth or sixth month of pregnancy, and the postnatal classes end when the children are 6 months old.
~Family Foundations is delivered in a community setting by childbirth educators who have received 3 days of training from Family Foundations staff."
16134406|NCT01901523|Behavioral|Reporting of discrepancy to journal|
16134407|NCT01901510|Drug|Chromoendoscopy (Indigo Carmine)|Indigo Carmine will be added to the colonic prep to attempt indirect chromoendoscopy
16134408|NCT01901510|Other|Control|The control will have minimal Indigo Carmine added to the colonic prep. This will serve to color the solution blue for blinding but not enough to provide significant staining for chromoendoscopy.
16134409|NCT01901497|Device|Nebulizer|500 mg/4 mL Amikacin nebulized using vibrating mesh nebulizer associated with a single limb bilevel ventilator. The nebulizations are considered as finished when there is no visible evidence of nebulization for a period of 30 seconds.
16134410|NCT01901484|Drug|Praziquantel|All the registered S. mansoni infected children aged 1-5 years will be randomly divided into two treatment arms: single and double dose. A second those will be administered after two weeks following the last treatment.
16134411|NCT01901471|Drug|Single bolus of Placebo of CicloMulsion® (Neurovive).|"The matching placebo of CicloMulsion® (Neurovive) is composed with refined Soya-bean oil, medium-chain triglycerides, egg lecithin, water-free glycerol, sodium oleate, sodium hydroxide, water injection. The qualitative composition of CicloMulsion® and its placebo only differ in the presence or absence of Cyclosporine A, so the final emulsions will be visually indistinguishable.
~The placebo use here is ready-to-use lipid emulsions, i.e. do not need any step of preparation or dilution.
~The placebo is provided in colourless glass bottles sealed with a rubber stopper, containing a nominal fill volume of 50 ml.
~The study treatment will be directly taken into the vial and injected via a catheter positioned within an antecubital vein. The injection will be performed slowly over 2 to 3 minutes."
16134569|NCT01900457|Other|approaches from psychophysics|
16134412|NCT01901471|Drug|Single bolus of cyclosporine A (CicloMulsion®, Neurovive)|"The investigational medicinal product is cyclosporine A (CicloMulsion®, Neurovive).
~Cyclosporine A is an immunosuppressive treatment usually used in the prevention of acute rejection after organ transplant, including cardiac transplantation. Usual dosages in organ transplantation are about 2.5 mg / kg per day in 2 doses.
~CicloMulsion® is ready-to-use lipid emulsions, i.e. do not need any step of preparation or dilution.
~Production blinded labelling, packaging and delivering the study drugs in every participating centre of the trial will be performed by a company following European Union's Good Manufacturing Practice.
~CicloMulsion® 5mg/ml is provided in colourless glass bottles sealed with a rubber stopper, containing a nominal fill volume of 50 ml.
~The study treatment will be directly taken into the vial and injected via a catheter positioned within an antecubital vein. The injection will be performed slowly over 2 to 3 minutes."
16134413|NCT01901458|Device|Spectra Optia® IDL-Set|Peripheral blood progenitor cell apheresis in G-CSF mobilized allogeneic donors using the Spectra Optia® cell separator
16134414|NCT01901458|Device|Spectra Optia® Collection Set|Peripheral blood progenitor cell apheresis in G-CSF mobilized allogeneic donors using the Spectra Optia® cell separator
16134415|NCT01901445|Behavioral|Educational action with focal group|
16134416|NCT01901432|Drug|Givinostat|"In Part A patients will treated in dose levels at the following daily doses of Givinostat:
~50 mg b.i.d.,
~100 mg b.i.d.;
~150 mg b.i.d.,
~200 mg b.i.d.;
~150 mg t.i.d.;
~200 mg t.i.d.. Intermediate dose levels and, consequently, additionally dose levels may be used to establish the Maximum Tolerated Dose.
~In Part B patients will be treated at the Maximum Tolerated Dose established in Part A. The product will be supplied as hard gelatine capsules for oral administration at the strength of 50 mg, 75 mg and/or 100 mg each."
16134417|NCT01901419|Drug|Nitroglycerin infusion|Nitroglycerin infusion during rewarming
16134418|NCT01901393|Drug|IV ibuprofen|
16134419|NCT01901393|Drug|Ketorolac|
16134420|NCT01901380|Dietary Supplement|Extensively hydrolyzed casein formula + LGG|
16134421|NCT01901367|Dietary Supplement|nutritional intervention|Receive nutritional intervention
16134422|NCT01901367|Behavioral|exercise intervention|Receive exercise intervention
16134423|NCT01901367|Other|follow-up care|Receive booster follow-up sessions from the nutritionist and exercise physiologist
16134424|NCT01901367|Behavioral|counseling intervention|Receive phone counseling with a trained health coach
16134425|NCT01901367|Other|quality-of-life assessment|Ancillary studies
16134426|NCT01901367|Other|laboratory biomarker analysis|Correlative studies
16134427|NCT01901367|Other|questionnaire administration|Ancillary studies
16134428|NCT01901354|Other|Low-tidal-volume ventilation|Goal tidal volume is 6 cc/kg ideal body weight.
16134429|NCT01901354|Other|Airway Pressure Release Ventilation (APRV)|APRV is a time cycled, inverse-ratio, pressure controlled strategy that allows spontaneous breathing through the respiratory cycle.
16134430|NCT01901341|Drug|CB-5945|
16134431|NCT01901341|Drug|Placebo|
16134432|NCT01901328|Drug|CB-5945|
16134433|NCT01901328|Drug|Placebo|
16134434|NCT01901315|Procedure|Online consultation|Patients in the online consultation (intervention) group have monthly consultation with their attending psychiatrist through videoconferencing during one year. After each consultation, the medication is sent to the patient through a home delivery program. For reasons of patient safety, consultations at baseline, and after 6 and 12 months will be realized in a face-to-face form at the Institute of Psychiatry (IPq).
16134435|NCT01901315|Procedure|Face-to-face consultation|Patients in the face-to-face consultation (control) group have monthly face-to-face consultation with their attending psychiatrist during one year at the Institute of Psychiatry (IPq).
16134436|NCT01901302|Drug|CB-5945|
16134437|NCT01901302|Drug|Placebo|
16134438|NCT01901289|Device|Zilver® PTX® Drug-Eluting Peripheral Stent|Treatment of symptomatic vascular disease of the native above-the-knee femoropopliteal arteries.
16134439|NCT01901276|Drug|Omeprazole 40 mg bid|As above.
16134440|NCT01901263|Behavioral|patients with alzheimer's disease|the Neuropsychiatric Inventory (NPI), is uded to assess 10 behavioral disturbances occurring in dementia patients: delusions, hallucinations, dysphoria, anxiety, agitation/aggression, euphoria, disinhibition, irritability/lability, apathy, and aberrant motor activity. The NPI uses a screening strategy to minimize administration time, examining and scoring only those behavioral domains with positive responses to screening questions.
16134441|NCT01901250|Dietary Supplement|Xylitol gummy bears|The children receive xylitol gummy bears 3 times/day within the supervised school environment.
16134442|NCT01901250|Dietary Supplement|Sugar free fiber gummy bears|The children receive sugar free fiber gummy bears 3 times/day within the supervised school environment.
16134443|NCT01901250|Behavioral|Oral health education|Oral health education, toothbrush, and fluoride toothpaste
16134444|NCT01901250|Device|Fluoride varnish|The study dentists apply the varnish on all children twice a year during the study period. The varnish is 5% sodium fluoride and contains 2.26% by weight fluoride ion in a colophony base.
16134445|NCT01901250|Device|Dental sealant|The study dentists apply the sealant on the children in the second grade when the permanent first molars are fully erupted.
16134446|NCT01901237|Behavioral|Hatha Yoga|This is a 7-week home/hospice-based instructive Hatha yoga program (available on DVD) for adolescent and young adults diagnosed with a non-curative cancer. Participants will be asked to complete a minimum of one, 75-minute yoga session per week. The DVD package includes four discs that increase in difficulty over the course of the 7-week program. The DVD focuses on postures and breathing exercises. Participants will be asked to keep track of the number and duration of yoga sessions completed over the 7-week period.
16134447|NCT01901224|Drug|Metformin 1000 mg|
16134448|NCT01901224|Drug|Placebo|
16134449|NCT01901211|Other|Exergaming Intervention|The exergaming system will be installed into the participants' homes. Players will pedal the exergame bike in order to move their game avatar. Headsets allow players to communicate with each other in real-time. Participants will play the games 3 to 5 times per week, during scheduled game times. Players will wear a heart rate (HR) monitor and will achieve game benefits for reaching their target HR. They will be asked to exercise in a target HR zone of 40-65%HR reserve. Each week, participants will receive a call from a research assistant (RA), who will provide feedback on their exercise progress and a HR goal for each week. The RA will also record physical and social activities engaged in and any difficulties like leg pain or technical issues.
16134450|NCT01901198|Biological|Human Serum Albumin/interferon alpha2a 300-1200 mcg single dose S.C.|Recombinant Human Serum Albumin/interferon alpha2a Fusion Protein 300-1200 mcg at Day 0
16134451|NCT01901198|Biological|Peginterferon 180 mcg single dose S.C.|Pegasys 180 mcg S.C. single dose on Day 0
16134452|NCT01901185|Drug|Etanercept / Autoinjector A|Autoinjector A, a hand-held, reusable electromechanical device, and a single-use, disposable cassette preassembled with an etanercept 50-mg liquid prefilled syringe (PFS).
16134453|NCT01901172|Drug|RO5503781|Single dose on Day 1 (high fat, low fat, or fasted), Day 10 (fasted, low fat, or high fat), and Day 19 (low fat, fasted, or high fat) in a crossover design
16134454|NCT01901172|Drug|RO5503781|Daily for 5 days followed by 23 days rest per cycle
16134455|NCT01901172|Drug|RO5503781|Single doses of current formulation, optimized MBP formulation and new SDP formulation, Days 1, 8 and 15 in a crossover design
16134456|NCT01901172|Drug|RO5503781|Single doses Days 1 and 11
16134457|NCT01901172|Drug|posaconazole|Multiple doses Days 8-14
16134458|NCT01901159|Drug|RO4995819|Oral doses of RO4995819 (tablet)
16134459|NCT01901159|Drug|RO4995819|Oral doses of RO4995819 (capsule)
16134460|NCT01901146|Drug|ABP 980|ABP 980 was administered at an initial dose of 8 mg/kg over a 90-minute intravenous (IV) infusion, then 6 mg/kg IV infusion Q3W for all subsequent cycles.
16134461|NCT01901146|Drug|Trastuzumab|Trastuzumab was administered at an initial dose of 8 mg/kg over a 90-minute IV infusion, then 6 mg/kg IV infusion Q3W for all subsequent cycles.
16134462|NCT01901146|Drug|Paclitaxel|Paclitaxel, 175 mg/m² Q3W for 4 cycles (or 80 mg/m² QW for 12 cycles, if local standard of care).
16134463|NCT01901146|Procedure|Lumpectomy or Mastectomy with Sentinel Node or Axillary Node Dissection|
16134464|NCT01901133|Drug|MDV3100|Oral
16134465|NCT01901120|Drug|Betanis|oral
16134466|NCT01901107|Drug|Kiklin capsules|oral
16134467|NCT01901094|Procedure|Axillary Lymph Node Dissection (ALND)|
16134468|NCT01901094|Radiation|Nodal Radiation Therapy|
16134469|NCT01901094|Radiation|Axillary Radiation Therapy|
16134470|NCT01901081|Device|IMES|"Once subjects recover from surgical implantation of IMES (approximately two weeks), they will practice IMES control using a bench-top IMES trainer for approximately a month. As soon as the subject's custom-fit IMES Prosthesis is available, it will be fitted and programmed. Subjects will then begin six months of prosthetic training. Month 1 training entails sessions with an Occupational Therapists 4-5 times per week. Months 2-6 Training entail meeting with an Occupational Therapist twice a month. During training, subject will learn how to contract residual musculature in the amputated limb to control movements of an electromechanical wrist and hand. The therapeutic goal is to develop skills needed to perform Activities of Daily Living using the IMES prosthesis.
~After completing six months of training, subjects will be given the option to continue using their IMES Prosthesis for another sixteen months."
16134471|NCT01901068|Device|MonoMax|Abdominal wall will be closed with MonoMax after an elective primary laparotomy.
16134472|NCT01901055|Device|CPAP|CPAP is a device that has a mask worn over the nose that is attached to a device that provides positive airway pressure. CPAP is worn while sleeping, it splints open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
16134473|NCT01901055|Device|Sham-CPAP|Sham-CPAP is a device that has a mask worn over the nose that is attached to a device that looks and sounds like CPAP however it does not provide positive airway pressure. Sham-CPAP is worn while sleeping, it does not splint open the airway and prevent apneas (cessation of breathing) and hypopneas (reduced airflow while breathing).
16134474|NCT01901055|Behavioral|Diabetes Education|Diabetes Education will be delivered to participants in both the CPAP group and the Sham-CPAP group. The education will be based on ADA and AADE guidelines and consist of 2 in-person sessions (90 minutes and 60 minutes) and 3 follow-up phone calls 9about 15 minutes each)
16134475|NCT01901042|Dietary Supplement|Symbiotic|Sachets with a symbiotic product in powder form containing 4.3 g of dietary fiber and Lactobacillus reuteri in a concentration greater than 1.0 x 108 colony forming units (CFU), with five grams per sachet (Fibermais Flora Nestlé Brazil).
16134476|NCT01901042|Dietary Supplement|Maltodextrin|Control patients will receive sachets containing maltodextrin
16134477|NCT01901016|Behavioral|Jacobson progressive muscular relaxation|PMR involves learning to identify the tension in specific muscle groups by tightening and relaxing each muscle group. It includes three different exercises: 1) contraction-relaxation of 12 large muscle groups in the arms, legs, and trunk; 2) identification and relaxation of tensions without the need for movement or contractions; and 3) contraction-relaxation of 12 small muscle groups in the neck, eyes, and mouth
16134478|NCT01901016|Behavioral|Schultz's autogenic training|AT is a relaxation technique that is based on body attitude, reduction of exterior stimulation, inner concentration, and mental repetition of verbal formulas [28]. These formulas are organized into six exercises: 1) heaviness; 2) warmth; 3) calm and regular heart function; 4) self-regulation of respiration; 5) warmth in the upper abdominal area; and 6) agreeable cooling of the forehead.
16134479|NCT01901003|Drug|Lorazepam|
16134480|NCT01901003|Other|no premedication|
16134481|NCT01901003|Drug|Placebo (microcrystalline celluloses)|
16134482|NCT01900990|Device|Noninvasive ventilation weaning|We adopt Noninvasive Positive Pressure Ventilation in tracheotomy patients by capping the tracheotomy tube and deflating the cuff
16134483|NCT01900977|Other|Universal Testing with immediate ART|"• Combination prevention package including:
~o House-to-house deployment of: Universal HIV counseling and testing; Active linkage to care for individuals diagnosed as HIV-infected, with immediate eligibility for ART; Promotion of male circumcision and prevention of mother to child transmission (PMTCT) services; Provision of condoms; Strengthening of HIV testing and services at health facilities and other venues; Strengthening of male circumcision and prevention of mother-to-child transmission of HIV services available in the community; and Treatment of sexually transmitted infections (STIs) and provision of condoms at health units"
16134522|NCT01900730|Behavioral|Pill Diary|Patient given a pill diary to record the time each dose taken.
16134523|NCT01900730|Behavioral|Drainage Diary|Patient completes daily diary of drainage with the date and amount of fluid drained each day at home. Drained fluid from the day before brought to each clinic visit to give to the research team.
16134524|NCT01900717|Drug|LV5FU2 simplified, FOLFOX 4 simplified, FOLFIRI modified|
16134484|NCT01900977|Other|Universal Testing with ART eligibility according to National Guidelines|"Combination prevention package including:
~House-to-house deployment of: Universal HIV counseling and testing; Active linkage to care for individuals diagnosed as HIV-infected, with ART eligibility according to national guidelines; Promotion of male circumcision and PMTCT services; Provision of condoms; Strengthening of HIV testing and services at health facilities and other venues; Strengthening of male circumcision and PMTCT services available in the community; and Treatment of STIs and provision of condoms at health units."
16134485|NCT01900977|Other|Standard of Care|
16134486|NCT01900964|Procedure|PTFE membrane|The non-resorbable PTFE barrier membrane will be surgically placed in conjunction with a ridge preservation procedure.
16134487|NCT01900964|Procedure|Collagen membrane|A resorbable collagen membrane is surgically placed in conjunction with a ridge preservation procedure.
16134488|NCT01900951|Drug|Temozolomide|
16134489|NCT01900938|Procedure|Continuous infusion of propofol|Propofol is continuously administered intravenously via infusion pump starting with 20 mg/kg/hr and then titrated to about 5 mg/kg/hr according to patients' sedation level.
16134490|NCT01900938|Procedure|Intermittent bolus injection of propofol|A loading dose of 2 mg of midazolam and 0.4 mg/kg of propofol is initially injected and then repeated intermittent bolus injection of 20 mg of propofol is followed according to patients' sedation level.
16134491|NCT01900938|Drug|Midazolam|
16134492|NCT01900938|Drug|Propofol|
16134493|NCT01900925|Procedure|Prescriptive Hip Exercises and Manual Therapy techniques|1) Clam Abduction exercises in sidelying, 2) Hip extension in quadruped, 3) a unilateral bridge,and; 1) anterior to posterior mobilization of the hip with distraction, 2) long axis distraction of the hip and 3) posterior-anterior mobilization of the hip in prone
16134494|NCT01900925|Procedure|Pragmatic low back pain treatment|"advise to stay active,
~discourage bed rest,
~appropriate medication use,
~reassurance.
~Short term use of manipulation/medication,
~supervised exercise,
~cognitive behavioral therapy,
~multidisciplinary treatment,
~termination of use of modalities."
16134495|NCT01900912|Other|CLTS|The goal of CLTS is to obtain Open Defecation Free (ODF) villages. CLTS aims to trigger the community's desire for change, propel them into action and encourage innovation, mutual support and appropriate local solutions, in order to foster greater ownership and sustainability. The phases are: pre-triggering (a group of trained-CLTS people visit the community and request a date to discuss sanitation-related issues for the following days), triggering (people are made to express their views on sanitation issues and their needs), monitoring (involves visits of the community twice a week for a period of 1-3 months) and certification (an external committee evaluates the village for certification as an ODF community).
16134496|NCT01900899|Procedure|Blood Sampling|At 2, 3, 4, 5, 6 years after booster vaccination.
16134497|NCT01900886|Other|Peginterferon alfa-2a|Treatment as usual clinical practice
16134498|NCT01900886|Drug|Ribavirin|Treatment as usual clinical practice
16134499|NCT01900873|Device|Inspiratory Muscle Strength Training|IMT will be performed using a variable flow resistive loading device (POWERbreathe®KH1, HaB International Ltd., Southam, UK). The device is able to store training parameters of up to 40 sessions. Most training sessions during this RCT will be performed by patients at their homes without supervision. The intervention group (strength IMT) will perform two daily sessions of 30 breaths. Measurements of Pi,max will be performed every week and training loads will be increased continuously to maintain at least 40-50% of the actual Pi,max values. Each week, one training session will be performed under supervision. Training load will be increased during this session.
16134500|NCT01900873|Device|Inspiratory Muscle Endurance Training|IMT will be performed using a variable flow resistive loading device (POWERbreathe®KH1, HaB International Ltd., Southam, UK). The device is able to store training parameters of up to 40 sessions. Most training sessions during this RCT will be performed by patients at their homes without supervision. The sham group (endurance IMT) will perform three daily sessions of 30 breaths and will train at a constant inspiratory load of no more than 10% of their initial Pi,max. Each week, one training session will be performed under supervision.
16134501|NCT01900860|Dietary Supplement|Vitamin D|Three different doses of vitamin D will be administered in a double-blinded fashion. The three doses are 400, 4000, or 10,000 IU/day
16134502|NCT01900847|Drug|Ketamine|0.3mg/kg ketamine
16134503|NCT01900847|Drug|Morphine|Dosage of morphine determined by treating physician
16134504|NCT01900847|Drug|placebo|saline of same volume as appropriate weight based dose of ketamine
16134505|NCT01900834|Other|No treatment given|The participants will not receive any treatment
16134506|NCT01900808|Device|Trained operator with M probe.|Trained operator with M probe: non-drug intervention, baseline comparator.
16134507|NCT01900808|Device|Experienced operator with M probe.|Experienced operator with M probe: non-drug intervention, longitudinal comparator.
16134508|NCT01900808|Device|Experienced operator with XL probe.|Experienced operator with XL probe: non-drug intervention, longitudinal comparator.
16134509|NCT01900795|Drug|V117957|V117957 4.5 mg suspension taken orally after surgery.
16134510|NCT01900795|Drug|Ibuprofen|Ibuprofen 400 mg tablets taken orally after surgery.
16134511|NCT01900795|Drug|Placebo|Placebo taken orally after surgery.
16134512|NCT01900782|Biological|Intervention A|Prefilled syringe.
16134513|NCT01900782|Biological|Intervention B|Prefilled syringe.
16134514|NCT01900782|Biological|Placebo|Prefilled syringe to match experimental drug and active comparator.
16134515|NCT01900769|Drug|Blood Volume Dilution|
16134516|NCT01900756|Behavioral|THRIVES|Pre-appointment phone text In-clinic educational video Patient report card Post-clinic phone text Outpatient stroke registry
16134517|NCT01900743|Drug|Regorafenib|Regorafenib (160 mg/d) once daily for three weeks on / one week off plus Best Supportive Care (BSC)until progression (according to RECIST 1.1), intolerance or consent withdrawal.
16134518|NCT01900743|Drug|Placebo|Placebo plus BSC until progression (according to RECIST 1.1) or unacceptable toxicity. Patients who have received placebo may be offered open-label regorafenib (cross-over option) after objective tumor progression
16134519|NCT01900730|Drug|Placebo|Patient takes placebo capsule 3 times a day by mouth for 10 weeks.
16134520|NCT01900730|Drug|Valproic Acid (VPA)|Patients initially receive daily oral VPA 15 mg/kg/day divided in three doses. If patient tolerates the reduced dose for 10 consecutive days, then the VPA dose will increase to 30 mg/kg/day divided into three doses. Patients treated for 10 weeks.
16134525|NCT01900717|Drug|LV5FU2 simplified,FOLFOX 4 simplified, FOLFIRI modified, Bevacizumab 5 mg/kg/ 2 weeks|
16134526|NCT01900704|Drug|SER120 750 ng|SER120 750 ng
16134527|NCT01900704|Drug|SER120 1500 ng|SER120 1500 ng
16134528|NCT01900704|Drug|Placebo|Placebo
16134529|NCT01900691|Device|Evolution® Esophageal Stent - Fully Covered|Placement of the Evolution® Esophageal Stent for benign or malignant strictures, fistulas, perforations or leaks with the intention of removal
16134530|NCT01900678|Device|VytronUS Ablation System|Pulmonary vein isolation.
16134531|NCT01900665|Drug|Solanezumab|Administered Intravenously (IV)
16134532|NCT01900665|Drug|Placebo|Administered IV
16134533|NCT01900652|Drug|Emibetuzumab|Administered IV
16134534|NCT01900652|Drug|Erlotinib|Administered Orally
16134535|NCT01900639|Behavioral|change time of intake of aspirin|
16134536|NCT01900626|Drug|epidural catheter|epidural catheter with 0.3% ropivacaine
16134537|NCT01900613|Behavioral|Ninos Sanos Familia Sana|
16134538|NCT01900600|Other|Cardiopulmonary exercise test|All patients will undergo a first CPX prior to initiation of treatment, a second one after 3 months, and a third one after 12 months of treatment.
16134539|NCT01900600|Other|Echocardiogram|An echocardiogram (ultrasound of the heart) will be performed prior to initiation of treatment and then again 12 months later.
16134540|NCT01900587|Drug|Tapentadol ER Tamper-resistant Formulation (TRF)|Single dose of tapentadol ER 50 milligram (mg), will be administered under fasted condition.
16134541|NCT01900587|Drug|Tapentadol ER Prolonged-Release 2 (PR2)|Single dose of tapentadol ER 50 milligram (mg), prolonged release tablet will be administered under fasted condition.
16134543|NCT01900561|Behavioral|Interactive Voice Response Symptom Management|The Interactive Voice Response (IVR) system will provide automated telephone monitoring of PC survivor symptoms and goals for symptom reduction, based on a patient empowerment approach.
16134544|NCT01900561|Behavioral|Tailored Newsletters|Personally tailored newsletters will incorporate elements of CBT to improve survivors' identification with the material, confidence/self-efficacy in symptom management, and to reduce common cognitive distortions related to successful implementation of behavior change. Information collected during automated phone assessments will be used to construct tailored newsletters, which will be sent following each automated call.
16134545|NCT01900548|Dietary Supplement|Whey protein (HPHL)|The Whey protein group are supplemented 45 gram of whey protein, high protein high leucine (HPHL), every day.
16134546|NCT01900548|Dietary Supplement|Soy protein (HPLL)|The Soy protein group are supplemented 45 gram of Soy protein, high protein low leucine (HPLL), every day.
16134547|NCT01900548|Dietary Supplement|Placebo (P)|Will not be given protein but the same energy content using maltodextrin (in a blended fashion).
16134548|NCT01900548|Other|Resistance training|For 45 minutes 3 times a week the participants will complete resistance training with elastic bands in their own homes.
16134549|NCT01900522|Drug|ITI-214 Dose A|ITI-214 Dose A Oral Solution
16134550|NCT01900522|Drug|ITI-214 Dose B|ITI-214 Oral Solution Dose B
16134551|NCT01900522|Drug|ITI-214 Dose C|ITI-214 Dose C Oral Solution
16134552|NCT01900522|Drug|ITI-214 Dose D (Elderly)|ITI-214 Dose D (Elderly) Oral Solution
16134553|NCT01900522|Drug|Placebo|ITI-214 Matching Placebo Oral Solution
16134554|NCT01900522|Drug|ITI-214 Dose E|ITI-214 Dose E Oral Solution
16134555|NCT01900522|Drug|ITI-214 Dose F|ITI-214 Dose F Oral Solution
16134556|NCT01900522|Drug|ITI-214 Dose G|ITI-214 Dose G Oral Solution
16134557|NCT01900522|Drug|ITI-214 Dose H|ITI-214 Dose H Oral Solution
16134558|NCT01900522|Drug|Placebo|ITI-214 Matching Placebo Oral Solution
16134559|NCT01900509|Drug|Bendamustine|Route of administration: intravenously (IV) over approximately 60 minutes, days 1-5.
16134560|NCT01900509|Drug|Clofarabine|Route of administration: IV days 1-5.
16134561|NCT01900509|Drug|Etoposide|Route of administration: IV days 1-5.
16134562|NCT01900509|Drug|Etoposide phosphate|Route of administration: Used in substitution for etoposide in participants who experience allergic reaction, Etopophos® will be administered IV.
16134563|NCT01900509|Drug|Dexamethasone|Route of administration: three times daily orally (by mouth), days 1-5.
16134564|NCT01900496|Biological|Brentuximab vedotin|Day 1 every three weeks (weeks 0, 3, 6, 9, ... 27): 1.8 mg/kg IV. Ten doses maximum.
16134565|NCT01900496|Biological|Rituximab|Day 1 of weeks 12, 13, 14, 15, 18, 21, 24, and 27: 375 mg/m^2 IV. Additional doses are given at three and six months post week 27.
16134566|NCT01900470|Behavioral|CHW Goal Support|IMPaCT CHWs will perform the following functions, depending on the needs of the participants: 1) Deconstructing Distal Goals into Proximal Goals: IMPaCT CHWs will help patients to deconstruct collaborative distal clinical goals into patient driven proximal goals and develop strategies for achieving each proximal goal.2) Creating Roadmaps: Roadmaps are individualized strategies for achieving each proximal goal identified by patients. 3) IMPaCT Partners conduct weekly follow-up with patients through either telephone or home visit in order to support the achievement of proximal goals. As part of these followup encounters, CHWs ask patients to measure their chronic disease control during their weekly followup calls/visits. 4) Group: CHWs and their Project Manager run a group session for patients in the IMPaCT arm. This group meets weekly and is a forum for patients to discuss common issues around chronic disease management and form a social support network.
16134567|NCT01900457|Other|electromyography|
16134568|NCT01900457|Other|electroencephalography|
16134570|NCT01900444|Biological|IMOJEV|0.5 mL, Subcutaneous
16134571|NCT01900431|Drug|Sarilumab|Pharmaceutical form: Prefilled syringes; Route of administration: Subcutaneous
16134572|NCT01900431|Drug|Prednisone|Pharmaceutical form: Tablet or Capsule; Route of administration: Oral
16134573|NCT01900431|Drug|Methotrexate|Pharmaceutical form: Tablet or Capsule or Suspension; Route of administration: Orally or intravenously or intramuscular
16134574|NCT01900431|Drug|Folic/folinic acid|Pharmaceutical form: Tablet or Capsule; Route of administration: Oral
16134575|NCT01900431|Other|Placebo (for Sarilumab)|Pharmaceutical form: Prefilled syringes; Route of administration: Subcutaneous
16134576|NCT01900418|Behavioral|Walk with Ease|An evidence-based walking program
16134577|NCT01900405|Drug|Dexmedetomidine|
16134578|NCT01900392|Behavioral|Financial incentive|Participants in the direct payment and lottery arms will receive financial incentives as part of the intervention. See arm descriptions for more detail.
16134579|NCT01900379|Procedure|CPAP treatment|This device consists in a nasal continuous positive airway pressure. It will be applied just after CABG and for 3 months for OSA/CPAP patients group.
16134580|NCT01900379|Other|Sham CPAP treatment|This device consists in a sham continuous positive airway pressure. It will be applied just after CABG and for 3 months for OSA/sham CPAP patients group.
16134581|NCT01900366|Procedure|Fat Biopsy|Fat biopsy
16134582|NCT01900353|Other|brushing methods|
16134583|NCT01900340|Dietary Supplement|Saline|Intravenous saline infusion and intraduodenal administration of saline via feeding tube
16134584|NCT01900340|Drug|Exendin 9-39|IV exendin(9-39) infusion and intraduodenal administration of saline via feeding tube
16134585|NCT01900340|Dietary Supplement|Saline|IV saline infusion and intraduodenal administration of nutrients
16134586|NCT01900340|Drug|Exendin(9-39) plus ID nutrient|Exendin(9-39) as intravenous infusion plus intraduodenal nutrient administration
16134587|NCT01900327|Radiation|External Beam Radiation|Neoadjuvant CRT with external beam radiation (EBRT) delivering a total dose of 50.4 Gy over 28 days in 1.8 Gy fractions.
16134588|NCT01900327|Drug|Gemcitabine neoadjuvant|weekly Gemcitabine 300mg/m2 for 6 weeks neoadjuvant
16134589|NCT01900327|Procedure|Surgery|Upfront pancreato-duodenectomy
16134590|NCT01900327|Drug|Gemcitabine adjuvant|Postoperative adjuvant Chemotherapy preferentially using Gemcitabine (1000 mg/m2 6 cycles at day 1, 8, 15 of each 28-day cycle. Administered in both arms, experimental AND active comparator
16134591|NCT01900314|Device|repetitive Transcranial Magnetic Stimulation (rTMS)|20 active sessions, within a 4 week period, where subjects receive the same repetitive Transcranial Magnetic Stimulation (rTMS) treatment parameters as the sham arm.
16134592|NCT01900301|Drug|Scopolamine|Participants will be randomized to either, .4mg/.01 mL Scopolamine, .5mg/.01 mL Scopolamine or .6mg/.01 mL Scopolamine, administered via nasal drops, prior to each session of exposure therapy
16134593|NCT01900301|Drug|intranasal placebo|Participants will be randomized to a drug placebo, administered via nasal drops, prior to each session of exposure therapy
16134594|NCT01900288|Behavioral|HPN Group Clinic Appointments using Mobile Devices (experimental)|Visual meetings with geographically distant professionals and peers using a mobile device (iPad mini).
16134595|NCT01900288|Behavioral|Mobile Device Access (placebo)|Use of iPad mini unrelated to the intervention until last contact with one connection to professionals for comparison.
16134596|NCT01900275|Other|Urine collection|Collection of 5 ml urine from urinary collection device (e.g. foley catheter).
16134597|NCT01900262|Other|Strengthening|Participants will be asked to complete 8 weeks of isolated ankle strengthening at home.
16134598|NCT01900262|Other|Balance Training|Participants will be asked to compete 8 weeks of functional balance training at home.
16134599|NCT01900262|Other|Stretching|Participants will be asked to complete a standard of practice static and dynamic stretching warm-up for 8 weeks at home.
16134600|NCT01900249|Drug|R348 Ophthalmic Solution, 0.2%|R348 Ophthalmic Solution, 0.2% 1 drop per eye twice a day for 12 weeks.
16134601|NCT01900249|Drug|R348 Ophthalmic Solution, 0.5%|R348 Ophthalmic Solution, 0.5% 1 drop per eye twice a day for 12 weeks.
16134602|NCT01900249|Drug|Placebo|Placebo Ophthalmic Solution 1 drop per eye twice a day for 12 weeks.
16134603|NCT01900236|Behavioral|Based on behavioral motivational interviewing (MI) technique|In addition to receiving standard clinic care, the intervention will have a tailored, interactive agenda for each of the 4 sessions based on behavioral motivational interviewing (MI) technique. The goal of this intervention is for the participant to establish early behaviors that help him/her to arrive at scheduled medical appointments and learn to take medications as prescribed during the initial year of HIV care in order to in order to achieve viral suppression and improve overall health.
16134604|NCT01900210|Behavioral|WaySafe|
16134605|NCT01900197|Drug|10% Iron Isomaltoside 1000|Administered according to local routines and product labeling in doses at the doctors discretion
16134606|NCT01900184|Drug|QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)]|
16134607|NCT01900184|Drug|Placebo|Contains magnesium stearate, silica dental type, anhydrous lactose
16134608|NCT01900171|Drug|QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)]|
16134609|NCT01900171|Drug|Placebo|Contains magnesium stearate, silica dental type, anhydrous lactose
16134610|NCT01900158|Drug|Amphinex, Gemcitabine and Cisplatin|Amphinex administration on day 0, followed by gemcitabine administration (1000 mg/m2) and laser light application (652 nm) on day 4 followed by systemic gemcitabine (1000 mg/m2) and cisplatin (25 mg/m2) given on Day 1 and Day 8 of each 21-day cycle, for up to a total of eight cycles. Either one or two PCI treatments (Amphinex, Gemcitabine and intraluminal laser light of 652nm) during the 8 cycles of chemotherapy
16134615|NCT01900106|Drug|abacavir/lamivudine + raltegravir|abacavir/lamivudine + raltegravir
16134616|NCT01900106|Drug|abacavir/lamivudine + darunavir/ritonavir|abacavir/lamivudine + darunavir/ritonavir
16134617|NCT01900093|Drug|Acthar Gel|80 units of subcutaneous Acthar Gel therapy daily
16134618|NCT01900080|Other|Same-Day HIV testing and ART initiation|Same-day HIV testing and ART initiation
16134619|NCT01900080|Other|Standard ART Initiation|Standard ART Initiation
16134620|NCT01900080|Other|Sub-Study: Same-Day ART, CD4 Count >500|Same-day CD4 count and ART initiation for patients with CD4 count >500 cells/mm3 (CD4 count within 7 days of HIV test)
16134621|NCT01900080|Other|Sub-Study: Standard Pre-ART Care, CD4 Count >500|Standard pre-ART care for patients with CD4 count >500 cells/mm3
16134622|NCT01900067|Device|BARRIER® EasyWarm Active Self-Warming Blanket|
16134623|NCT01900054|Drug|Bepotastine besilate|Two TAU-284 5mg tablets will be taken orally twice a day
16134624|NCT01900041|Drug|Pantovigar|1 capsule of Pantovigar for oral intake, given three times a day. Duration of treatment: 6 months.
16134625|NCT01900041|Drug|Minoxidil 2% only|1 ML of Minoxidil 2% solution twice a day applied to the scalp. Duration of treatment: 6 months.
16134626|NCT01900028|Procedure|Pharmacokinetic sampling|Blood samples taken pre and post dosing with olaparib+/- itraconazole
16134627|NCT01900028|Drug|Olaparib tablet dosing|Olaparib tablets: Part A 100mg od, days 1 and 9 only. Part B 10x300mg doses over 5 days (300mg bd).
16134628|NCT01900028|Drug|Itraconazole|Itraconazole 200mg od Part A days 5 to 11 only
16134629|NCT01900015|Drug|Raltegravir|Patients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current regimen.
16134630|NCT01900015|Drug|Efavirenz|Patients on current EFV plus two nucleoside analogs will be randomly assigned to switch EFV to RAL (400mg BID), maintaining nucleoside analogs unchanged, or to continue the current regimen.
16134631|NCT01900002|Other|Laboratory Biomarker Analysis|Correlative studies
16134632|NCT01900002|Other|Quality-of-Life Assessment|Ancillary studies
16134633|NCT01900002|Drug|Sorafenib|Given PO
16134634|NCT01900002|Drug|Sorafenib Tosylate|Given PO
16134635|NCT01900002|Radiation|Yttrium Y 90 Glass Microspheres|Given IA
16134636|NCT01899989|Radiation|Stereotactic Body Radiation Therapy (SBRT)|
16134637|NCT01899989|Drug|cisplatin or carboplatin-based|Standard chemotherapy with a histology-selected cisplatin or carboplatin-based doublet will be administered intravenously as adjuvant therapy. Gemcitabine will be used for squamous cell carcinomas and pemetrexed will be used for non-squamous non-small cell lung cancer. Cisplatin or carboplatin will be used in combination with the histology-selected agent. The choice of cisplatin or carboplatin will be at the discretion of the treating medical oncologist.
16134638|NCT01899976|Device|X-Suit NIR Covered Biliary Stent|
16134639|NCT01899924|Behavioral|Event Related Potentials recording|
16134640|NCT01899911|Device|Vital Signs Patch (VSP)|Infrared and red absorbance measurement
16134641|NCT01899898|Other|Simplified Modified Atkins Diet|"Modified Atkins diet with the following modifications:
~Pictorial representation of various food items and exchange lists will be provided.
~Instead of weights, we will provide standardized measures
~We will calculate the amount of carbohydrates of daily readily available foods in the standardized measures
~We will formulate recipes and diets based on locally available and culturally acceptable foods.
~We will develop a parent instruction manual.
~We will also develop methods for parents with low levels of literacy to maintain seizure logs. This will be done by using bars and color codes.
~We will develop methods for parents with low levels of literacy to measure and record urine ketones. This will be done by using color codes."
16134642|NCT01899898|Drug|Antiepileptic drugs alone|The anti-epileptic drugs will be continued alone for 3 months following which they will be offered Simplified Modified Atkins Diet
16134643|NCT01899885|Procedure|AHA (Acute Highrisk Abdominalsurgery): Optimized Course|"optimized course: Intervention before, during and after abdominal surgery.
~Focus on fast track with multimodal standardized intervention:
~standardized preparing for surgery including high dose antibiotics and epidural analgesia etc. and transfer to intermediate care before surgery (the post-anaesthesia care unit)
~GDT-LiDCO fluid management pre-, per- and postoperative
~Postoperative triage to 24 hour intermediate care based on ASA score and Surgical Apgar Score
~Focus on early mobilization, fysiotherapy and optimal nutrition postoperatively"
16134644|NCT01899872|Behavioral|Resistance exercise session|Resistance exercise session consisting of 4 lower-limb exercises, with 4 sets, 12 repetitions per set, at an intensity of 60% of maximal strength.
16134645|NCT01899872|Behavioral|Aerobic exercise session|Aerobic exercise session consisting of 40 minutes of lower-limb bicycle.
16134646|NCT01899859|Drug|GR-MD-02|GR-MD-02; galactoarabino-rhamnogalaturonate
16134647|NCT01899859|Drug|Placebo|GR-MD-02 Placebo
16134648|NCT01899846|Drug|Hydroxyprogesterone caproate 250 mg/ml|
16134649|NCT01899833|Diagnostic Test|99mTc-Sestamibi|An injection of 99mTC-Sestamibi will be administered by IV push under medically observed conditions.
16134650|NCT01899820|Drug|Artemether lumefantrine|Artemether 20mg Lumefantrine 120mg
16134651|NCT01899820|Drug|Dihydroartemisinin piperaquine|Dihydroartemisinin 20mg Piperaquine 160mg
16134652|NCT01899807|Device|OssDsign AB|
16134653|NCT01899794|Procedure|TVT-O/Oxytrol|
16134654|NCT01899794|Device|TVT-O|
16134655|NCT01899794|Drug|Oxytrol|
16134656|NCT01899781|Drug|Antibiotic-Cefamezin|
16134657|NCT01899768|Drug|GSK2339345|Clear colorless solution in clear glass vial for oral inhalation via aqueous droplet inhaler with unit dose strength of 1000 microgram (mcg) inhaled in two actuations.
16134658|NCT01899768|Drug|Placebo|Clear colorless solution of 0.9% sodium chloride for oral inhalation via aqueous droplet inhaler inhaled in two actuations.
16134659|NCT01899755|Drug|GSK2800528, solution for injection|Drug will be administered at 3 different dose levels by subcutaneous injection.
16134660|NCT01899755|Drug|Placebo (0.9% w/v Sodium Chloride), solution for injection|Subcutaneous injection of. 0.8 mL solution will be administered
16134661|NCT01899755|Drug|Adalimumab, solution for injection|Subcutaneous injection of 0.8 mL solution will be administered (40mg)
16134662|NCT01899742|Drug|Umeclidinium/Vilanterol 62.5/25 mcg|Inhalation Powder
16134663|NCT01899742|Drug|Tiotropium 18 mcg|Inhalation Powder
16134664|NCT01899729|Drug|IMO-8400 Regimen 1|IMO-8400 0.075 mg/kg q wk x 12 wk by subcutaneous injection
16134665|NCT01899729|Drug|IMO-8400 Regimen 2|IMO-8400 0.15 mg/kg q wk x 12 wk by subcutaneous injection
16134666|NCT01899729|Drug|IMO-8400 Regimen 3|IMO-8400 0.3 mg/kg q wk x 12 wk by subcutaneous injection
16134667|NCT01899729|Drug|Saline Placebo|Saline q wk x 12 wk by subcutaneous injection
16134668|NCT01899729|Drug|IMO-8400 Regimen 4|IMO-8400 0.6 mg/kg q wk x 12 wk by subcutaneous injection
16134669|NCT01899716|Other|Exercise|
16134670|NCT01899703|Drug|GSK2330672|GSK2330672 oral preserved solution 1.5mg/g will be supplied in amber glass bottles and as per randomization schedule subject will receive 45 mg BID from Day 1 to 3 and 90 mg BID from Day 4 to 14 of one of the two treatment periods.
16134671|NCT01899703|Drug|Placebo|Placebo oral preserved solution will be supplied in amber glass bottles and as per randomization schedule subject will receive placebo BID from Day 1 to 14 of one of the two treatment periods. .
16134672|NCT01899703|Drug|Ursodeoxycholic acid|UDCA 250 mg will be supplied in capsule form. The subjects, who are taking UDCA at the time of Run-in-period, will be continued on the same total daily dose of drug but converted to a standardized formulation and a standardized dosing regimen administering the entire daily dose once daily in the evening before bedtime. Once daily dosing of UDCA will continue for the duration of the study.
16134673|NCT01899690|Drug|antibiotic|Patients after breast reconstruction with implant/tissue expander reconstruction who receive the intervention will be prescribed with a 7 day course of postoperative antibiotics.
16134674|NCT01899677|Other|distilled water|0.5 cc distilled water twice daily will be added to the breast milk or formula during 30 days
16134675|NCT01899677|Drug|symbiotic|Symbiotic 1/2 sachet twice daily will be added to the breast milk or formula during 30 days
16134676|NCT01899664|Procedure|Nerve Transfer Surgery|Unilateral surgery will be performed under general non-paralytic anesthesia and no-tourniquet conditions to allow for responsive nerve simulation.
16134677|NCT01899638|Drug|UMEC/VI 125/25 mcg|Combination in high dose
16134678|NCT01899638|Drug|UMEC/VI 62.5/25 mcg|Combination in low dose
16134679|NCT01899638|Drug|UMEC 125 mcg|LAMA mono in high dose
16134680|NCT01899638|Drug|UMEC 62.5 mcg|LAMA mono in low dose
16134681|NCT01899638|Drug|VI 25 mcg|LABA mono
16134682|NCT01899625|Behavioral|Brief Behavioral Weight Loss (BWL)|12 Week treatment program consisting of 2, 90-minute individual sessions, followed by weekly PDF modules via email, and reporting of key behaviors and feedback via email. Treatment consistent with behavioral weight loss, low calorie, low fat diet. Increased physical activity of up to 250 minutes/week.
16134683|NCT01899625|Behavioral|Motivation Enhanced BWL|12 week treatment program consisting of 2, 90-minute individual sessions with a focus on motivation, followed by weekly PDF modules via email, and reporting of key behaviors and feedback via email. Participants will pick from one of three dietary goals and one of three physical activity goals.
16134684|NCT01899599|Drug|PankoMab-GEX|start dose 500mg at C0D1, maintenance dose 1700mg at CxD1, Number of Cycles: until progression or unacceptable toxicity develops.
16134685|NCT01899599|Drug|Placebo|start dose matching 500mg at C0D1, maintenance dose matching 1700mg at CxD1, Number of Cycles: until progression or unacceptable toxicity develops.
16134686|NCT01899586|Other|Regional Specific Training Stimulus (RSTS)|The RSTS protocol was designed to focus on specific peripheral muscle groups without imposing a significant cardiorespiratory strain. Each exercise involved contractions with moderate load but with an extended duration of up to six minutes. Eight specific exercises were performed to target all major muscle groups and enable the routine to be completed within 60 minutes including warm-up, rest periods and stretching between exercises, and cool down exercises.
16134687|NCT01899586|Other|Aerobic Exercise Regimen (AE)|Whole-body aerobic exercise at >50% of heart rate reserve (HRR) for 45 minutes, three days per week.
16134688|NCT01899573|Device|AccuCinch® Ventriculoplasty System|Percutaneous intervention for the treatment of functional mitral regurgitation
16134689|NCT01899560|Procedure|Measure lung and chest wall elastance with esophageal catheter|"Patients will be in supine position with 30-45° head of bed elevation. The cuff of the endotracheal tube will be transiently overinflated to 60 cmH2O to ensure there will be no air leaks. NMBA (cisatracurium) will be administrated [9]. The fraction of inspired oxygen (FiO2) will be adjusted for continuously monitored oxygen saturation (SpO2) between 90 to 94%. Patients will be ventilated in pressure control with 15 cmH2O of driving pressure.
~A low flow pressure/volume curve from 0 to 40 cmH2O will be performed."
16134690|NCT01899560|Other|non-invasive method for measuring the lung elastance|by measuring volume recruited during a change of pressure (∆PEEP/∆EELV)
16134691|NCT01899547|Procedure|laparoscopic-assisted rectal resection|Arm I: Patients undergo laparoscopic-assisted rectal resection.
16134692|NCT01899547|Procedure|conventional open rectal resection|Arm II: Patients undergo conventional open rectal resection.
16134693|NCT01899534|Other|E-screening|E-screening will be conducted on a computer tablet with wireless access. The tablet will be configured with the screening tool currently used in each clinic. The content and order of individual questions will be identical to the paper-pen version. Response options will be listed in full view under each question. Women select responses by touching the screen.
16134694|NCT01899521|Procedure|Bronchoscopy|Involves flexible fiberoptic bronchoscopy with standardized bronchoalveolar lavage (BAL) technique (isotonic saline in a sub-segment of the right middle lobe or lingula) using standard conscious sedation techniques.
16134695|NCT01899521|Dietary Supplement|Zinc sulfate 220 mg once daily|
16134696|NCT01899521|Dietary Supplement|S-adenosylmethionine 400 mg twice daily|
16134697|NCT01899508|Procedure|Virtual Reality Training Session|The participant will meet with an interventionist for an hour and a half long session. During this session OA knee pain will be assessed (using self report questionnaires) prior to and post a 10 minute session using the 3D viewer and having a brief pain coping skills training.
16134698|NCT01899508|Device|3D viewer with iPod Touch/iPhone (or similar smartphone)|The participant will meet with an interventionist for an hour and a half long session. During this session OA knee pain will be assessed (using self report questionnaires) prior to and post a 10 minute session using the 3D viewer and having a brief pain coping skills training.
16134699|NCT01899495|Other|High sodium diet and low sodium diet|Isocaloric diet with 60 mEq of potassium and 1gm protein/kg body weight with high sodium 300mEq; low sodium 10 mEq.
16134700|NCT01899482|Other|Manual Lymphatic Drainage|
16134701|NCT01899482|Behavioral|Education|Behavioral education.
16134702|NCT01899469|Procedure|Electromagnetic Therapy|20 sessions from Monday to Friday of 20 minutes of Electromagnetic Therapy, using the next parameters: 10 Hz of frequency and 60% of intensity, and 20 sessions from Monday to Friday of 25 minutes of Back School, the exercises were based on the re-education of breathing, self stretching trunk muscles, erector spine reinforcement, abdominal reinforcement and postural exercises. The participants had been performing 8 to 10 repetitions of each exercise and they had been recommended about making a series more at home.
16134703|NCT01899469|Procedure|Transcutaneous Electrical Neurological Stimulation|"Procedure/Surgery: Transcutaneous Electrical Neurological Stimulation (TENS)
~20 sessions from Monday to Friday of 20 minutes of TENS Therapy using the next parameters: 100μs of impulse width, 80 Hz of impulse frequency, and 20 sessions from Monday to Friday of 25 minutes of Back School, the exercises were based on the re-education of breathing, self stretching trunk muscles, erector spine reinforcement, abdominal reinforcement and postural exercises. The participants had been performing 8 to 10 repetitions of each exercise and they had been recommended about making a series more at home."
16134704|NCT01899469|Procedure|Back School|25 minutes of Back School, the exercises were based on the re-education of breathing, self stretching trunk muscles, erector spine reinforcement, abdominal reinforcement and postural exercises. The participants had been performing 8 to 10 repetitions of each exercise and they had been recommended about making a series more at home.
16134705|NCT01899456|Device|Catheter-based renal denervation|
16134706|NCT01899443|Other|Observation|This is an observational study observing relationship between routine care and outcomes after total hip or knee arthroplasty.
16134707|NCT01899430|Drug|liraglutide|
16134708|NCT01899430|Drug|metformin|
16134709|NCT01899417|Device|ConforMIS iTotal® Knee Replacement|Patients that received a ConforMIS iTotal knee replacement versus other knee replacement devices.
16134710|NCT01899404|Biological|18-FDG PET/CT, DWI, DCE-MRI|All patients on this study will receive a Diffuse Weighted MRI and Dynamic Contrast Enhancing MRI during the routine MRI session on the day of brachytherapy (additional 10 minutes), and a FDG PET/CT scanning session on the day of brachytherapy.
16134711|NCT01899378|Dietary Supplement|Lactobacillus reuteri DSM 17938|10^8 CFU
16134712|NCT01899378|Dietary Supplement|Bifidobacterium longum infantis|10^9 CFU
16134713|NCT01899352|Procedure|Tracheostomy|Percutaneous and surgical tracheostomies will be performed with the procedure currently available in clinical practice.
16134714|NCT01899339|Other|Ultra sound energy along with tPA to treat submassive pulmonary embolism|
16134715|NCT01899326|Drug|Desipramine Hydrochloride|Given PO
16134716|NCT01899326|Biological|Filgrastim|Given PO
16134717|NCT01899326|Other|Laboratory Biomarker Analysis|Correlative studies
16134718|NCT01899313|Behavioral|CBT- based SMS text messaging intervention|
16134719|NCT01899313|Behavioral|CBT group therapy|
16134720|NCT01899300|Device|Metal Stent (WallFlex™ Esophageal RX)|
16134721|NCT01899287|Behavioral|group education|"The experimental intervention consists of:
~A. Group education on general skin-protective behaviour. B. Group education and counselling on work-related skin-protective behaviour, which might extend to a work-place visit.
~C. Social guidance related to OHE. D. Telephone hot-line for work and case-related problems, maintained by nurse."
16134722|NCT01899274|Device|bant iPhone application|
16134723|NCT01899261|Radiation|Stereotactic Radiosurgery|Undergo SBRT
16134724|NCT01899248|Drug|Sevoflurane|
16134725|NCT01899248|Drug|Desflurane|
16134726|NCT01899235|Device|drug eluting balloon|
16134727|NCT01899235|Device|drug eluting stent|
16134728|NCT01899222|Device|Handheld fundus photography|diagnostic imaging with two types of retina camera
16134729|NCT01899209|Procedure|STARR|
16134730|NCT01899209|Procedure|Laparoscopic Ventral Rectopexy|
16134731|NCT01899196|Biological|blood sampling,|
16134732|NCT01899183|Procedure|Anti-reflux Surgery|Nissen Fundoplication; Collis Gastroplasty
16134733|NCT01899170|Procedure|Deep brain stimulation|Implantation of a deep brain stimulation electrode into pain processing brain areas
16134734|NCT01899170|Device|Cervel Neurotech, Multi-coil TMS|Non-invasive selective stimulation of deep brain areas using magnetic fields.
16134735|NCT01899170|Drug|11C-Carfentanil|PET-radioligand for functional brain imaging to assess opioid binding. The compound is a potent synthetic opioid.
16134736|NCT01899144|Drug|Albuterol Spiromax|Albuterol Spiromax® Inhalation Aerosol contains 90 mcg albuterol per actuation orally inhaled in a single dose dry powder inhaler (DPI). Participants took doses at either the 90 or 180 mcg levels. If the higher level, two DPIs filled with Albuterol Spiromax® were used.
16134737|NCT01899144|Drug|ProAir HFA|ProAir® HFA Inhalation Aerosol contains 90 mcg albuterol per actuation orally inhaled in a single dose metered dose inhaler (MDI). Participants took doses at either the 90 or 180 mcg levels. If the higher level, two MDIs filled with ProAir HFA were used.
16134738|NCT01899144|Drug|Placebo|Single dose MDIs and DPIs containing placebo taken as a single orally-inhaled actuation each.
16134739|NCT01899131|Device|platform-switch tapered internal implants|Laser-Lok permanent abutment/ new Laser Lok platform-switch implant assembly.assessment at 6,12,24 month clinicaly and radiographic
16134740|NCT01899118|Radiation|Preoperative irradiation|50.4Gy/28F/5.5w
16134741|NCT01899118|Drug|Nimotuzumab|400mg/w，0-5w
16134742|NCT01899118|Drug|Oxaliplatin|130mg/m2 d1
16134743|NCT01899118|Drug|Capecitabine|825mg/m2 bid d1-5/w,1-5w
16134744|NCT01899105|Drug|lumacaftor|
16134745|NCT01899105|Drug|ivacaftor|
16134746|NCT01899092|Drug|TT-034|The study drug will be given as a single dose IV infusion on Day 1. 5 different dose levels corresponding to the 5 cohorts of the study will be given.
16134747|NCT01899066|Drug|Lucentis, chemotherapy|"Lucentis:0.50mg/0.05ml, intravitreal injection,monthly for the first six months.
~chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2."
16134748|NCT01899066|Drug|chemotherapy|chemotherapy:vincristine,1.5mg/m2;carboplatin,560mg/ m2;etoposide,150 mg/ m2.
16134749|NCT01899053|Drug|TAK-228|TAK-228 Capsules
16134750|NCT01899053|Drug|TAK-117|TAK-117 Capsules
16134751|NCT01899040|Device|neuromodulation for episodic migraine headache|
16134873|NCT01898130|Procedure|quality-of-life assessment|Ancillary studies
16134752|NCT01899027|Drug|Rosuvastatin|Patients will receive two overnight high doses of Rosuvastatin (40 mg 12 h before RNA and another 10 mg dose 2 h before the procedure
16134753|NCT01899027|Drug|Placebo|Patients will receive two overnight doses of Placebo 12 h before RNA and another dose 2 h before the procedure
16134754|NCT01899001|Behavioral|Cognitive Behavioral Therapy|Participants will receive weekly, 30 minute sessions with a CBT-trained clinical psychologist for the first 8 weeks. Briefly, the purpose of CBT is to treat mood and associated anxiety disorders by changing dysfunctional thoughts that lead to negative mood states and maladaptive behaviors. Through the use of Socratic questioning, the therapist challenges the patient to observe the relationship between thoughts and feelings and to question the underlying beliefs that perpetuate negative affect. Ultimately, patients learns to recognize maladaptive automatic thoughts and develop a more rational and balanced way of thinking about themselves and the world around them.
16134755|NCT01899001|Behavioral|Nutrition Counseling|All women will receive nutrition/exercise counseling by a trained counselor. They will consume a self-selected diet of 1500-1800kcal/d of conventional foods based on the Food Guide Pyramid. Participants will also have an exercise goal that starts at 50 minutes per week and increases to 175 minutes per week. Sessions will teach standard weight loss skills, including self-monitoring, problem-solving, enlisting social support, and overcoming negative thoughts. Subjects will be asked to keep daily food intake and exercise logs which will be reviewed at the nutrition counseling sessions. These sessions will occur in person once weekly lasting on average 30 minutes for 16 sessions.
16134756|NCT01898975|Other|500ml fluid loading|Fluid loading to evaluate fluid responsiveness
16134757|NCT01898962|Procedure|Complete Surgical Removal|
16134758|NCT01898962|Radiation|Stereotactic Radiosurgery|
16134759|NCT01898962|Radiation|Ablative external beam radiation dose|
16134760|NCT01898962|Procedure|Subtotal surgical removal plus ablative radiation dose|Residual tumor or close/positive margins should be followed by ablative radiation doses (by either stereotactic radiosurgery or convential EBRT) to constitute definitive locoregional treatment
16134761|NCT01898962|Radiation|Radioembolization|radioembolization of the liver with Y-90 microspheres or other site-appropriate techniques
16134762|NCT01898949|Other|Cold Exposure|Participants will spend 20 minutes per day 5 times a week (workdays) in a cold room wearing light clothes (T-shirt, shorts and light shoes) for 4 weeks.
16134763|NCT01898936|Procedure|Pretreatment with CO2 laser before photodynamic therapy|"The treatment will be a field treatment performed with a 30 W Lutronic carbondioxide laser; covering one of the symmetrical treatment areas allocated to fractional carbondioxide laser.
~The laser settings will be as follows:
~The fluence will initially be 10mJ/cm2 delivered with a 120 micron tip (producing 120 micron ablative columns) with 5% density. The fluence will be increased until the patient experiences pain (pain indicating penetration to dermis), and then reduced to maximum fluence without pain. Allocation to laser therapy is blinded for the future evaluator.
~The PDT procedure includes application of Metvix cream on the skin on both symmetrical areas with a thickness of approximately 1 mm, plastic covering for 30 minutes before entering daylight for 2 hours."
16134764|NCT01898936|Device|Only photodynamic therapy|
16134765|NCT01898923|Drug|ON101 Cream|
16134766|NCT01898923|Other|Aquacel® Hydrofiber® dressing|
16134767|NCT01898910|Procedure|PVI+renal denervation|After AF ablation procedure, the angiogram of both renal arteries is performed via femoral access. After that the treatment catheter is introduced into each renal artery and is applied discrete, radiofrequency ablations lasting up to 2 min each and of 8 watts or less to obtain up to six ablations separated both longitudinally and rotationally within each renal artery. During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm. After the procedure the control arterial angiogram should be done.
16134768|NCT01898910|Procedure|PVI + GP ablation|To accomplish ganglionated plexi ablation, LA target sites were identified as the anatomic locations where vagal reflexes were evoked by transcatheter high-frequency stimulation (HFS). Rectangular electrical stimuli were delivered at a frequency of 20-50 Hz, output amplitude 15 V and pulse duration of 10 ms, for 5 sec (Stimulator B-53, Biotok Inc, Russia).
16134769|NCT01898910|Drug|Optimal medial therapy (OMT)|Antiarrhythmic and antihypertensive therapy will be administered according to the guidelines
16134770|NCT01898897|Procedure|epidural catheter insertion|A catheter is placed in the epidural space at thoracic level. Analgesia is realised with local anesthetics (Bupivacaine plain 0.125%), administered from the beginning of surgical intervention and 12 hours postoperative on the postoperative care unit and intensive care unit at a rate of 6-8 ml/hour.
16134771|NCT01898897|Procedure|robot assisted laparoscopic urogenital surgery|The urogenital laparoscopic surgery is assisted by DaVinci robot. The majority of interventions were prostatectomies.
16134772|NCT01898884|Drug|VP 20629|
16134773|NCT01898884|Drug|Placebo|
16134774|NCT01898871|Dietary Supplement|A daily ration of 40 kcal/kg of body weight during 56 days|On enrollment, children were examined by a pediatrician to assess their health status and they were de-wormed with one tablet of Mebendazole 500 mg.
16134775|NCT01898858|Device|Hypercapnia inhalation (Altitrainer NP 190)|Hypercapnia inhalation using an Altitrainer NP 190
16134776|NCT01898858|Device|Hypoxia and hypercapnia (Altitrainer NP 190)|Hypoxia and hypercapnia inhalation using an Altitrainer NP 190
16134777|NCT01898858|Device|Hypoxia inhalation (Altitrainer NP 190)|Hypoxia inhalation using an Altitrainer NP 190
16134778|NCT01898845|Drug|LEE011|
16134779|NCT01898819|Drug|Dexmedetomidine|
16134780|NCT01898819|Drug|saline|
16134781|NCT01898806|Drug|Intralesional Triamcinolone 2.5 mg/ml|Intralesional Triamcinolone at a strength of 2.5 mg/ml. Patients will receive intradermal injection of study medication once per month to all, or as many as possible, areas of hair loss up to the maximum dose of 30 mg IL TAC per month, for a total of 6 months.
16134782|NCT01898806|Drug|Intralesional Triamcinolone 5 mg/ml|Intralesional Triamcinolone at a strength of 5 mg/ml. Patients will receive intradermal injection of study medication once per month to all, or as many as possible, areas of hair loss up to the maximum dose of 30 mg IL TAC per month, for a total of 6 months.
16134783|NCT01898806|Drug|Intralesional Triamcinolone 10 mg/ml|Intralesional Triamcinolone at a strength of 10 mg/ml. Patients will receive intradermal injection of study medication once per month to all, or as many as possible, areas of hair loss up to the maximum dose of 30 mg IL TAC per month, for a total of 6 months.
16134784|NCT01898806|Drug|Intralesional Saline|Intralesional Saline (Placebo). Patients will receive intradermal injection of study medication once per month to all, or as many as possible, areas of hair loss for a total of 6 months.
16134785|NCT01898793|Drug|Fludarabine|
16134786|NCT01898793|Drug|Cyclophosphamide|
16134787|NCT01898793|Procedure|Leukapheresis|
16134788|NCT01898793|Biological|Cytokine-induced killer cells|
16134789|NCT01898793|Biological|IL-2|
16134790|NCT01898793|Drug|ALT-803|
16134791|NCT01898793|Procedure|Peripheral blood for correlative studies|-Screening, Day 0 prior to CIML NK infusion, Day 1, Day 3, Day 7, Day 8, Day 10, Day 14, Day 21, Day 28, Day 42, Day 60, Day 100, 6 months, 9 months, 12 months, and at disease relapse
16134792|NCT01898793|Procedure|Bone marrow for correlative studies|-Screening, Day 8, Day 14, Day 28, Between Day 42 and 60, Day 100, at disease relapse
16134793|NCT01898780|Procedure|pancreaticojejunostomy with horizontal mattress suture|
16134794|NCT01898780|Procedure|pancreaticojejunostomy with interrupted suture|
16134795|NCT01898754|Other|Pre-ART Oligonucleotide Assay (OLA)|Block randomization (1:1) to pre-ART OLA testing or OLA testing after 12mo on ART
16134796|NCT01898741|Radiation|24 Gy in 3 fractions|
16134797|NCT01898728|Drug|topical povidone-iodine after premedication with topical liquid eye drops|
16134798|NCT01898728|Drug|topical povidone-iodine after premedication with topical gel|
16134799|NCT01898715|Drug|ATR-101|
16134800|NCT01898702|Behavioral|Diabetes expert patients programme|Nine-weekly informative and educational sessions by a teaching patient who has experience on diabetes
16134801|NCT01898689|Drug|Ropivacaine 0.1%|A sciatic catheter was inserted and ropivacaine 0.1% was administered as a basal infusion for 6 hours.
16134802|NCT01898689|Drug|Ropivacaine 0.4%|A sciatic catheter was inserted and ropivacaine 0.4% was administered as a basal infusion for 6 hours.
16134803|NCT01898676|Drug|Divalproex Sodium Extended-release 250mg|Two tablets of Divalproex Sodium Extended-Release 250mg will be given to the subject in two treatment periods
16134804|NCT01898676|Drug|DEPAKOTE 250mg|Two tablets of DEPAKOTE 250mg will be given to the subject in two treatment periods.
16134805|NCT01898663|Biological|Adenovirus-transfected DC + CIK|Adenovirus-transfected autologous DC vaccine plus CIK cells
16134806|NCT01898650|Other|MR scan|
16134807|NCT01898637|Other|Augmented pulse oximetry using incentive spirometer.|Augmented pulse oximetry using incentive spirometer.
16134808|NCT01898637|Device|Incentive spirometer.|The incentive spirometer is a simple passive device that measures the amount of air a person can inhale.
16134809|NCT01898624|Drug|mirabegron|oral
16134810|NCT01898611|Drug|Ghrelin|Ghrelin
16134811|NCT01898611|Drug|Placebo|Saline will be used as a placebo
16134812|NCT01898598|Drug|Placebo|Participants will receive matching placebo to vismodegib for 12 weeks.
16134813|NCT01898598|Drug|Vismodegib|Participants will receive vismodegib 150 mg oral capsule once a day for 12 weeks
16134814|NCT01898585|Drug|Zelboraf|Vemurafenib 960 mg twice a day until progressive disease, unacceptable toxicity, consent withdrawal, death, reasons deemed by the treating physician or study termination.
16134815|NCT01898572|Other|Standard care|Newly T2DM and control individuals will be controlled by their family care physician following standard (clinical guidelines) care.
16134816|NCT01898559|Other|Switch to smoking only little cigars|Participants smoke only little cigars for 15 days.
16134817|NCT01898546|Procedure|Primary angioplasty|Primary angioplasty preceded by 300 mg aspirin plus 600 mg clopidogrel oral load doses. The radial approach and the use of thrombus aspiration catheters will be recommended. Stent will be implanted in all cases. Balloon pre-dilatation or direct stenting will be decided according to lesion characteristics.
16134818|NCT01898546|Procedure|Postconditioning|1 min after stent deployment, the angioplasty balloon will be re-inflated 4 times during 1 min at low-pressure (4 to 6 atmospheres), each separated by 1 min of reflow.
16134819|NCT01898520|Drug|Sativex|Oromucosal spray containing THC (27 mg/mL):CBD (25 mg/mL), in ethanol: propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Each 100 μL spray delivered THC 2.7 mg and CBD 2.5 mg. The maximum number of daily sprays was 12.
16134820|NCT01898520|Drug|Placebo|Oromucosal spray containing ethanol: propylene glycol(50:50) excipients, with peppermint oil (0.05%) flavouring and colourings FD&C Yellow No.5 (E102 tartrazine) (0.0260%), FD&C Yellow No.6 (E110 sunset yellow) (0.0038%), FD&C Red No. 40 (E129 Allura red AC) (0.00330%) and FD&C Blue No.1 (E133 Brilliant blue FCF) (0.00058%). Each 100 μL spray administered to the sub-lingual or oral mucosa delivered the colourants plus excipients. The maximum daily dose was 12 sprays per day.
16134821|NCT01898507|Other|Low nicotine cigarettes|15-day period of smoking low nicotine content cigarette level 1: 0.25 mg nicotine content, followed by a 15-day period of smoking low nicotine content cigarette level 2: 0.08 mg nicotine content.
16134822|NCT01898494|Procedure|therapeutic conventional surgery|Undergo transoral surgical resection
16134823|NCT01898494|Radiation|intensity-modulated radiation therapy|Undergo low-dose IMRT
16134824|NCT01898494|Drug|cisplatin|Given IV
16134825|NCT01898494|Drug|carboplatin|Given IV
16134826|NCT01898494|Radiation|intensity-modulated radiation therapy|Undergo standard-dose IMRT
16134827|NCT01898494|Other|laboratory biomarker analysis|Correlative studies
16134828|NCT01898494|Other|quality-of-life assessment|Ancillary studies
16134829|NCT01898468|Procedure|Pericostal Closure Technique|
16134830|NCT01898468|Procedure|Intracostal Closure Technique|
16134831|NCT01898455|Device|RhinoChill intranasal cooling|The RhinoChill device will be used to locally cool the posterior nasopharynx, surrounding tissues and vasculature using a variable cooling flow rate based on patient comfort and tolerance, for a maximum of 20 minutes. Local anaesthetic spray will be administered to patients if the nasal catheters or cooling is poorly tolerated.
16134832|NCT01898442|Drug|Ticagrelor 180mg|Rndomization to standard or high ticagrelor loading dose regimens
16134833|NCT01898442|Drug|Ticagrelor 270mg|Randomization to standard or high loading dose regimen
16134834|NCT01898442|Drug|Ticagrelor 360mg|Randomization to standrad or high loading dose regimen
16134835|NCT01898429|Device|SCC DBS|Deep Brain Stimulator
16134836|NCT01898416|Drug|5-AMINOLEVULINIC ACID (5-ALA), is a non fluorescent prodrug.|"60 mg/kg 5-ALA prepared solution given orally, 3-5 hours before induction of anesthesia.
~Red light laser given by a Dye laser system, wave length of 635nm, in s dose of 150J/cm for 2000 seconds (33 minutes) will be given to tumor bed. In case of positive margins a second operation and 5-ALA administration or irradiation will be given."
16134837|NCT01898403|Drug|Indocyanine green solution|Administered peri-tumoral and intradermally
16134838|NCT01898403|Drug|Isosulfan blue (ISB)|Administered peri-tumoral and intradermally
16134839|NCT01898403|Diagnostic Test|Lymphoscintigraphy with 99-technetium (99Tc) sulfur colloid (TSC)|
16134840|NCT01898390|Procedure|Transplant|Bilateral Neural Allo-Transplantation with Fetal Ventral Mesencephalic Tissue
16134841|NCT01898377|Drug|Imatinib mesylate, Mycophenolate mofetil|
16134842|NCT01898364|Drug|GZ402666|Pharmaceutical form:lyophilized powder reconstituted for infusion Route of administration: intravenous
16134843|NCT01898351|Other|Fava bean, Lupin, Beef meat, Green pea, Hemp, Buckwheat|"The intervention visit involves a test meal to be consumed by subjects attending the Human Nutrition Unit in the morning, following an overnight fast. The meal will be consumed within 15 minutes and blood (69 mL) and urine samples will be collected during 24 hours.
~The test meals are designed to contain the same amount of proteins. Alternative protein meals: a number of bread buns for each meal containing individual alternative protein flours (green pea, lupin, hemp, buckwheat, fava beans). These will deliver 30 g of protein, the remainder being provided by white flour. The control (meat) meal: a lean beef steak containing 30 g of protein and a bun containing the same amount of white flour as used for the alternative protein bread buns.
~The semi structured interview guide: will take place within the Human Nutrition Unit during one of the scheduled visits, once initial screening has taken place and participants have been selected. All interviews will be digitally recorded."
16134844|NCT01898338|Drug|Fosfomycin 2gr/6h iv|
16134845|NCT01898338|Drug|Daptomycin 10mg/kg/24h iv|
16134846|NCT01898325|Device|Fibroscan|Fibroscan
16134847|NCT01898312|Drug|Mifepristone|Randomised controlled trial of Mifepristone and placebo comparator Triobe
16134848|NCT01898299|Device|transcranial Direct Current Stimulation (tDCS)|A neurostimulation technique that passes an extremely weak electric current through the brain.
16134849|NCT01898299|Device|Sham tDCS|Sham (inactive) tDCS treatment
16134850|NCT01898286|Drug|DiaPep277®|1 mg of DiaPep277® subcutaneously in the upper arm at 0, 3, 6, 9, 12, 15, 18, and 21 months, for a total of 8 administrations
16134851|NCT01898273|Drug|I-124-CLR1404|single-dose, intravenous
16134852|NCT01898260|Device|Ultrafilcon B contact lens|Silicone hydrogel contact lens CE-marked for daily disposable wear. Private-label versions may be used.
16134853|NCT01898260|Device|Stenfilcon A contact lens|Silicone hydrogel contact lens CE-marked for daily disposable wear. Private-label versions may be used.
16134854|NCT01898247|Other|Simulation-based mastery learning|Internal Medicine residents are randomly selected to undergo simulation-based mastery learning.
16134855|NCT01898234|Device|Revaclear|Four polysulfone dialyzers of 1.8 m2, A (Revaclear, Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone low flux, Fresenius), were compared with each other
16134856|NCT01898234|Device|Helixone high flux|Four polysulfone dialyzers of 1.8 m2, A (Revaclear, Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone low flux, Fresenius), were compared with each other
16134857|NCT01898234|Device|Xevonta|Four polysulfone dialyzers of 1.8 m2, A (Revaclear, Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone low flux, Fresenius), were compared with each other
16134858|NCT01898234|Device|Helixone low flux|Four polysulfone dialyzers of 1.8 m2, A (Revaclear, Gambro), B (Helixone high flux, Fresenius), C (Xevonta, BBraun) and D (Helixone low flux, Fresenius), were compared with each other
16134859|NCT01898221|Drug|Ethanol|We enter the CS with a sheath advanced from the right internal jugular vein. A sub-selector catheter with a ~90° angle at the tip (typically, a left internal mammary artery angioplasty guide catheter) is advanced through the CS sheath with its tip pointing superiorly and posteriorly.
16134860|NCT01898221|Procedure|Ablation|The doctor will perform only the standard procedure. Throughout the procedure, the researchers will document the following information for ALL patients: measurements such as whether the treatment was successful or unsuccessful, X-ray exposure time, procedure time, whether there were any complications, and other general procedural measurements.
16134861|NCT01898208|Device|FilmArray testing|FilmArray Blood Culture Identification (BCID) Panel is a polymerase chain reaction (PCR) panel that identifies 19 types of bacteria, 5 types of fungi, and select antimicrobial-resistance genes.
16134862|NCT01898208|Behavioral|Antimicrobial Stewardship|Real time antimicrobial stewardship: an infectious diseases pharmacist or physician will provide patient-specific recommendations to modify antimicrobial therapy.
16134863|NCT01898208|Other|Bacterial culture|This test identifies the pathogen responsible for an infection.
16134864|NCT01898208|Other|Susceptibility testing|Antibiotic susceptibility testing determines the susceptibility of a bacterial strain to a specific antibiotic or a panel of antibiotics. Antibiotic susceptibility testing determines the susceptibility of a bacterial strain to a specific antibiotic or a panel of antibiotics.
16134865|NCT01898195|Drug|Varenicline|Varenicline will be provided for three months.
16134866|NCT01898195|Behavioral|Text Message|Text messages will be developed twice daily for three months
16134867|NCT01898195|Behavioral|Adherence Behavioral Therapy|Seven Adherence Behavioral Therapy sessions will given over a three month period
16134868|NCT01898182|Other|Kinetin, N6-furfuryladenine, 0.1%|
16134869|NCT01898169|Other|NJOY King 26 mg nicotine Electronic Nicotine Delivery System|NJOY® King ENDS, menthol or nonmenthol, ad libitum use for 1 week NJOY® King ENDS, menthol or nonmenthol, 2 series of puffs, with a 30-second interpuff interval in each series and 1 hour between the first puff in each series.
16134870|NCT01898156|Drug|BIW-8962|"Phase 1 -With a standard 3+3 dose escalation design, the enrollment in Phase 1 will proceed until the MTD has been defined or the highest dose level has been reached. BIW-8962 will be administered intravenously on day 1 of each 21 day cycle.
~Phase 2 - RP2D of BIW-8962 determined in phase 1 portion will be administered until progression or unacceptable toxicity develops."
16134871|NCT01898143|Other|Whole body vibration|
16134872|NCT01898130|Biological|bevacizumab|Given IV
16134878|NCT01898104|Radiation|preoperative radiation therapy|25 Gy in 5 fractions over 1 week
16134879|NCT01898104|Drug|Valproic Acid|
16134880|NCT01898104|Drug|Capecitabine|
16134881|NCT01898091|Drug|Neem Mouthrinse|10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.
16134882|NCT01898091|Drug|Placebo Mouthrinse|10ml dose of assigned study mouthrinse, three times per day, for approximately 7 weeks during radiation therapy.
16134883|NCT01898078|Drug|Alisertib|Alisertib ECT
16134884|NCT01898065|Drug|18-F-MISO|PET scan with the 18 Fluoro Misonidazole
16134885|NCT01898052|Drug|single anaesthetic drug|inject periarticular tissue of the knee after implantation
16134886|NCT01898052|Drug|multimodal drug injection|inject periarticular tissue of the knee
16134887|NCT01898039|Biological|A2/4-1BBL melanoma vaccine|On days 14, 35, 56, 77 and 98 the appropriate dose of irradiated M20/A2B cells will be injected into three adjacent sites on the upper arm or thigh, avoiding limbs where lymph node dissection had been previously performed.
16134888|NCT01898039|Procedure|DNP sensititzation|"Include brand names, serial numbers and code names, if applicable. Other names are used to improve search results on the ClinicalTrials.gov web site.
~On days 1 and 2 patients will be sensitized to DNP by topically applying 0.1 ml of 2% DNP dissolved in acetone-corn oil (Sigma) to the inner aspect of the arm."
16134889|NCT01898039|Drug|Cyclophosphamide|On day 10, intravenous low dose cyclophosphamide, 300 mg/m2, will be administered.
16134890|NCT01898026|Dietary Supplement|Bread|Samples of white bread, with or without the addition of PGX fibre blend
16134891|NCT01898026|Dietary Supplement|Mashed Potatoes|samples of mashed potatoes, with or without the addition of soluble fibre blend
16134892|NCT01898026|Dietary Supplement|Muffins|Samples of muffins, with or without the addition of PGX fibre blend
16134893|NCT01898026|Dietary Supplement|Hot Breakfast Cereal|Samples of hot breakfast cereal without the addition of soluble fibre blend
16134894|NCT01898013|Drug|Pregnenolone|
16134895|NCT01898013|Drug|Placebo|
16134896|NCT01898000|Behavioral|Triphala mouthwash|Subjects were instructed to use 15ml mouthwash twice daily and were instructed not to rinse/eat anything for 30 min after mouthwash use. Subjects were also asked to refrain from all other unassigned forms of oral hygiene aids, including dental floss and chewing gum during the study. No oral hygiene instructions like brushing and flossing were given to the subjects to exclude the influence of improved oral hygiene practices on the results.
16134897|NCT01898000|Behavioral|Chlorhexidine mouthwash|Subjects were instructed to use 15ml mouthwash twice daily and were instructed not to rinse/eat anything for 30 min after mouthwash use. Subjects were also asked to refrain from all other unassigned forms of oral hygiene aids, including dental floss and chewing gum during the study. No oral hygiene instructions like brushing and flossing were given to the subjects to exclude the influence of improved oral hygiene practices on the results.
16134898|NCT01897987|Biological|Pneumostem®|
16134899|NCT01897987|Biological|normal saline|
16134900|NCT01897974|Other|Survey|Families complete survey to measure medication compliance.
16134901|NCT01897961|Other|Anticorps anti-PLA2R1|
16134902|NCT01897948|Other|Milk-based beverage without DHA|
16134903|NCT01897948|Other|Milk-based beverage with DHA at mid level|
16134904|NCT01897948|Other|Milk-based beverage with DHA at high level|
16134905|NCT01897922|Other|An investigational infant formula containing a probiotic source|
16134906|NCT01897922|Other|Control: Marketed routine infant formula|
16134907|NCT01897896|Drug|SD-809|SD-809 tablets will be provided in dose strengths of 6, 9 and 12 mg.
16134908|NCT01897870|Behavioral|HomeCoMe-program|A home visit by patients own community pharmacist within seven days after hospital discharge. The community pharmacist will perform a semi-structured interview on (1) use of the prescribed medication, (2) ADEs, (3) adherence issues, by (A) assessing patient's needs and concerns around his pharmacotherapy, (B) identifying and solving obstacles for medicines intake, (C) checking on the need for a compliance aid, (D) collecting spare medication and finally (4) knowledge on medication use, when to take which medicine and why, and medication changes made during the hospitalisation.
16134909|NCT01897857|Device|duplex Doppler ultrasonography|
16134910|NCT01897844|Drug|ITF2984 (100, 2000, 3000 mcg bid)|
16134911|NCT01897844|Drug|Placebo|
16134912|NCT01897831|Drug|xin te mie|durg:Piperacillin Sodium and Sulbactam Sodium for Injection(2:1) 1.5-3.0g,iv,bid for 7-14 days Serious infections:6.0-12.0g,iv,tid for 7-14 days
16134913|NCT01897818|Device|communication system P300 Speller|
16134914|NCT01897805|Drug|Heart-protecting Musk Pill|
16134915|NCT01897805|Drug|Placebo|
16134916|NCT01897792|Dietary Supplement|Vitamin C|
16134917|NCT01897792|Dietary Supplement|Vitamin E|
16134918|NCT01897792|Dietary Supplement|Saline (for Vitamin C)|0.9% saline administered to mimic Vitamin C
16134919|NCT01897792|Drug|Placebo (for Vitamin E)|Sugar pill administered to mimic Vitamin E
16134920|NCT01897779|Drug|RPX7009|Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation in cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort. 14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6.
16134921|NCT01897779|Drug|RPX2014|Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation for cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort. 14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6.
16134922|NCT01897779|Drug|Placebo|Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation for cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort. 14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6.
16134923|NCT01897779|Drug|Combination RPX7009 and RPX2014|Two (2) groups of 15 subjects (12 active and 3 placebo) are planned for evaluation in cohort 1. Cohorts 2-5, 14 subjects (11 active and 3 placebo) are planned for evaluation in each cohort. 14 subjects (12 active and 2 placebo) are planned for evaluation in cohort 6.
16134924|NCT01897766|Drug|Somatropin|0.23 mg to 0.48 mg/kg/week
16134925|NCT01897753|Drug|growth hormone|36 months
16135071|NCT01896726|Drug|Microgynon|Administered orally
16134926|NCT01897740|Drug|sildenafil|tablets of sildenafil 20 mg 3 times a day for subjects with body weight > 20 kg and 10 mg TID for subjects with body weight ≤ 20 kg. If subject is 18 years of age or older, the recommended dose is 20 mg TID, regardless of body weight.
16134927|NCT01897727|Drug|Spironolactone|
16134928|NCT01897727|Drug|BP medication uptitration|antihypertensive medication added or uptitrated following standard of care
16134929|NCT01897714|Drug|Melflufen|
16134930|NCT01897714|Drug|Dexamethasone|
16134931|NCT01897701|Biological|Monovalent Avian Influenza VLP (H7N9)|
16134932|NCT01897701|Biological|Adjuvant 1|
16134933|NCT01897701|Biological|Placebo|
16134934|NCT01897688|Biological|Islet Cell Transplant|
16134935|NCT01897675|Procedure|Incision and Drainage with packing (wick) placement|
16134936|NCT01897675|Procedure|Abscess drainage with loop placement|
16134937|NCT01897662|Dietary Supplement|NUTRIOSE FB06|14g/day NUTRIOSE FB06: 7g in 250 mL orange juice twice a day
16134938|NCT01897662|Dietary Supplement|GLUCIIDEX 21|7g/day GLUCIDEX 21 : 3.5g in 250 mL orange juice twice a day
16134939|NCT01897649|Dietary Supplement|NUTRIOSE FB06|15g/day NUTRIOSE FB06
16134940|NCT01897649|Dietary Supplement|GLUCIDEX 21|15g/day GLUCIDEX 21
16134941|NCT01897636|Procedure|EUS-guided fine-needle injection of DCs vaccinations|
16134942|NCT01897623|Other|ultrasound of aorta|
16134943|NCT01897610|Drug|Immuncell-LC|intravenous dripping of 200ml(10^9~2x10^10 lymphocytes/60kg adult) for 1 hour
16134944|NCT01897597|Drug|BI 144807 high dose|oral solution
16134945|NCT01897597|Drug|BI 144807 intermediate dose|tablet
16134946|NCT01897597|Drug|BI 144807 intermediate dose|tablet
16134947|NCT01897597|Drug|BI 144807 intermediate dose|tablet
16134948|NCT01897597|Drug|BI 144807 intermediate dose|tablet
16134949|NCT01897597|Drug|BI 144807 intermediate dose|oral solution
16134950|NCT01897597|Drug|BI 144807 high dose|tablet
16134951|NCT01897584|Other|inverse IE|in only one group changes of I:E ratio would be applied
16134952|NCT01897571|Drug|Tazemetostat|
16134953|NCT01897558|Device|Pacemaker implantation|
16134954|NCT01897545|Procedure|Circumferential PV isolation|The left atrium (LA) and pulmonary veins (PVs) are explored through a transeptal approach. Real-time 3D LA maps are reconstructed by using a nonfluoroscopic navigation system. The ipsilateral left and right PVs are encircled in one lesion line by circumferential PV isolation. Radiofrequency energy is delivered at 43°C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and is reduced to 43°C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation speed of 17 mL/min. Each lesion is ablated continuously until the local potential amplitude decreased by >80% or RF energy deliveries exceeded 40 s. The endpoint of circumferential PV isolation is PV isolation. Additional ablation lines are created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the roof of the LA between the two superior PVs. After the end of the procedure the implantable loop recorder is implanted in the parasternal area of the chest.
16134955|NCT01897545|Procedure|PV isolation+renal denervation|"The procedure of AF ablation is the same like in the circumferential PV isolation.
~After AF ablation procedure, the angiogram of both renal arteries is performed via femoral access. After that the treatment catheter is introduced into each renal artery and is applied discrete, radiofrequency ablations lasting up to 2 min each and of 8 watts or less to obtain up to six ablations separated both longitudinally and rotationally within each renal artery. During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm. After the procedure the control arterial angiogram should be done."
16134956|NCT01897532|Drug|Placebo|placebo matching tablets
16134957|NCT01897532|Drug|Linagliptin|
16134958|NCT01897519|Drug|Placebo|Placebo infusion
16134959|NCT01897519|Drug|ABT-719|Arm 1 lower dose, arm 2 intermediate dose, arm 3 high dose
16134960|NCT01897493|Drug|Evacetrapib|Administered orally
16134961|NCT01897493|Drug|Digoxin|Administered orally
16134962|NCT01897480|Biological|LY2875358|Administered IV
16134963|NCT01897480|Drug|Erlotinib|Administered Orally
16134964|NCT01897467|Behavioral|Wii Fit|Exercises to be done on the Wii Fit include: warrior pose, half-moon pose, lunges, side lunges, balance bubble, ski slalom, soccer heading, and table tilt.
16134965|NCT01897467|Behavioral|Wait-List Control|Participants maintain currently physical activity and diet habits for 12 weeks. They have the option to participate in the intervention at the end of the 12-week period, but it is not mandatory.
16134966|NCT01897454|Drug|Fluorouracil|Given IV
16134967|NCT01897454|Drug|Gemcitabine Hydrochloride|Given IV
16134968|NCT01897454|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16134969|NCT01897454|Drug|Irinotecan Hydrochloride|Given IV
16134970|NCT01897454|Drug|Leucovorin Calcium|Given IV
16134971|NCT01897454|Drug|Oxaliplatin|Given IV
16134972|NCT01897441|Drug|Cyclophosphamide|Given IV
16134973|NCT01897441|Other|Cytology Specimen Collection Procedure|Correlative studies
16134974|NCT01897441|Drug|Doxorubicin Hydrochloride|Given IV
16134975|NCT01897441|Other|Laboratory Biomarker Analysis|Correlative studies
16134976|NCT01897441|Drug|Paclitaxel|Given IV
16134977|NCT01897441|Biological|Trastuzumab|Given IV
16134978|NCT01897428|Drug|Test-Bepotastine salicylate 9.64 mg|
16134979|NCT01897428|Drug|Reference-bepotastine besilate 10 mg|
16134980|NCT01897415|Biological|Autologous T cells transfected with chimeric anti-mesothelin immunoreceptor SS1|
16134981|NCT01897402|Biological|Test Vaccine|NmVac4-A/C/Y/W-135-DT™ conjugate is a vaccine in liquid form composed of purified polysaccharides (PS) conjugated to diphtheria toxoid. Single intramuscular 0.5 mL dose contains 4 µg each of Serogroup A, C, W-135, and Y PS conjugated to approximately 26 µg total diphtheria toxoid.
16134982|NCT01897402|Biological|US Licensed Vaccine|Meningococcal (Groups A,C,Y,W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine 0.5 mL dose, intramuscular. Single dose contains 4 µg each Serogroup A, C, W-135 and Y conjugated to approximately 48 µg total diphtheria toxoid.
16134983|NCT01897389|Drug|Treatment A|1000 mg abiraterone acetate (4 250-mg tablets - current commercial formulation, reference drug) administered as a single oral dose under fasted conditions
16134984|NCT01897389|Drug|Treatment B|1000 mg abiraterone acetate (4 250-mg tablets - new formulation) administered as a single oral dose under fasted conditions
16134985|NCT01897389|Drug|Treatment C|1000 mg abiraterone acetate (2 500-mg tablets - new formulation) administered as a single oral dose under fasted conditions
16134986|NCT01897389|Drug|Treatment D|1000 mg abiraterone acetate (4 250-mg tablets - same composition as current commercial formulation) administered as a single oral dose under fasted conditions
16134987|NCT01897389|Drug|Treatment E|1000 mg abiraterone acetate (2 500-mg tablets - same composition as current commercial formulation) administered as a single oral dose under fasted conditions
16134988|NCT01897376|Procedure|Pfannenstiel incision|Pfannenstiel incision at time of cesarean section
16134989|NCT01897376|Procedure|vertical skin incision|vertical skin incision at time of cesarean section
16134990|NCT01897363|Other|Infants with Prader-Willi Syndrome|Participants will be admitted to the outpatient clinical research center for IV placement, blood draws from the IV, poking the participants finger to obtain small amounts of blood and monitored 6 hour fast.
16134991|NCT01897350|Other|Cardiac magnetic resonance imaging|
16134992|NCT01897337|Drug|Aprepitant|We administrate aprepitant with small amount of water to aprepitant group in pre treatment room. (Before patient get in the operating room)And we administrate ondansetron 4mg to both group 20 minutes before the end of surgery.
16134993|NCT01897337|Drug|placebo|Patient in placebo group will be given Placebo in the PTR. And we administrate ondansetron 4mg to both group 20 minutes before the end of surgery.
16134994|NCT01897324|Drug|Growth hormone (Norditropin, Novo nordisk)|
16134995|NCT01897311|Device|transcutaneous electrical nerve stimulation|
16134996|NCT01897298|Behavioral|Urban training|Recommendation to walk a minimum of 5 days per week in urban walkable trails appropriate for the patient.
16134997|NCT01897285|Device|AQUACEL® foam adhesive dressing|
16134998|NCT01897272|Behavioral|Splinting|One group will have their wrist splinted after their carpal tunnel release surgery.
16134999|NCT01897259|Drug|Placebo Injection|Participants in the placebo group will recieve placebo injections (1cc 1% lidocaine and 1cc normal saline).
16135000|NCT01897259|Behavioral|Physical Therapy|Subjects participating in the physical therapy group will attend physical therapy and be prescribed to NSAIDS. No prolotherapy or corticosteroid injections.
16135001|NCT01897259|Drug|Corticosteroid Injections|Participants in the corticosteroid group will recieve corticosteroid injections (1 cc Kenalog 10 mg). They will also recieve anesthetic of 1 ml 1% lidocaine.
16135002|NCT01897259|Drug|Prolotherapy|Subjects participating in the prolotherapy group will recieve 1 cc 50% Dextrose and Sodium Morrhuate 1 cc injections.
16135003|NCT01897246|Procedure|Corrective osteotomy with computer-assisted pre-operative planning|The corrective osteotomy will be planned with computer-assisted pre-operative planning and virtual osteotomy.
16135004|NCT01897246|Procedure|Corrective osteotomy with conventional preoperative planning|The corrective osteotomy will be planned with conventional preoperative planning.
16135005|NCT01897233|Drug|Lumacaftor|
16135006|NCT01897233|Drug|Ivacaftor|
16135007|NCT01897207|Biological|Dendritic cell application|S.C. injection of peptide pulsed autologous dendritic cells
16135008|NCT01897181|Device|Hearing aids|Using hearing aids for 12 months
16135009|NCT01897168|Device|No intervention|
16135010|NCT01897155|Other|SBP 20-30% over baseline|Patients were assigned to receive a phenylephrine infusion in order to maintain systolic blood pressure (SBP) 20% to 30% over the baseline. The upper limit of systolic blood pressure is 165 mmHg.
16135011|NCT01897155|Other|SBP 20-30% under baseline|Patients were assigned to receive a phenylephrine infusion in order to maintain systolic blood pressure (SBP) 20% to 30% below the baseline. The lower limit of systolic blood pressure is 75 mmHg
16135012|NCT01897142|Biological|PF-05230907|0.1 micrograms per kilogram of PF-05230907, IV bolus, single dose
16135013|NCT01897142|Drug|Placebo for PF-05230907|0.1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
16135014|NCT01897142|Biological|PF-05230907|0.3 micrograms per kilogram of PF-05230907, IV bolus, single dose
16135015|NCT01897142|Drug|Placebo for PF-05230907|0.3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
16135016|NCT01897142|Biological|PF-05230907|1 micrograms per kilogram of PF-05230907, IV bolus, single dose
16135017|NCT01897142|Drug|Placebo for PF-05230907|1 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
16135018|NCT01897142|Biological|PF-05230907|2 micrograms per kilogram of PF-05230907, IV bolus, single dose
16135019|NCT01897142|Drug|Placebo for PF-05230907|2 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
16135020|NCT01897142|Biological|PF-05230907|3 micrograms per kilogram of PF-05230907, IV bolus, single dose
16135021|NCT01897142|Drug|Placebo for PF-05230907|3 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
16135022|NCT01897142|Biological|PF-05230907|5 micrograms per kilogram of PF-05230907, IV bolus, single dose
16135023|NCT01897142|Drug|Placebo for PF-05230907|5 micrograms per kilogram of placebo for PF-05230907, IV bolus, single dose
16135024|NCT01897116|Drug|Hydroxychloroquine (HCQ)|
16135025|NCT01897116|Drug|Vemurafenib (VEM)|
16135026|NCT01897090|Other|Elimination Diet|
16135027|NCT01897090|Other|Dietary Guidelines for Americans|
16135028|NCT01897077|Drug|Peanut Dissolving Film|
16135029|NCT01897064|Behavioral|Aerobic Exercise|36 sessions of aerobic exercise (12 weeks of 3 times/week, 60-minute exercise sessions) in small groups (3-5 individuals), in addition to standard psychiatric care.
16135030|NCT01897064|Other|Standard Psychiatric Treatment|Standard psychiatric treatment.
16135031|NCT01897051|Drug|Rifaximin + propranolol|"Rifaximin : taking 400mg three times a day in the study period (total 1,200 mg per day)
~Propranolol : taking 40mg twice a day to start. If patient is tolerable and systolic blood pressure is above 90 mmHg, the dosage can be increased by doubling to every other day upto the 360mg per day.
~(Target heart rate : 25% reduction in baseline heart rate or at least 55 times per minute).
~If patient is not tolerable, we can reduce the dosage step-by-step until the adverse symptoms is disappeared."
16135072|NCT01896713|Other|MS3TMRI|Multispectral 3 Tesla MRI imaging with contrast followed by biopsy
16135443|NCT01893814|Dietary Supplement|Probiotics|
16135032|NCT01897051|Drug|Propranolol + Placebo|"Placebo of Rifaximin : taking 400mg three times a day in the study period (total 1,200 mg per day)
~Propranolol : taking 40mg twice a day to start. If patient is tolerable and systolic blood pressure is above 90 mmHg, the dosage can be increased by doubling to every other day upto the 360mg per day.
~(Target heart rate : 25% reduction in baseline heart rate or at least 55 times per minute).
~If patient is not tolerable, we can reduce the dosage step-by-step until the adverse symptoms is disappeared."
16135033|NCT01897038|Drug|Onartuzumab|Onartuzumab intravenous infusion at a starting dose of 10 or 15 milligram per kilogram body weight administered every 3 weeks (Q3W) until disease progression or unacceptable toxicity occurs (maximum up to 31 months).
16135034|NCT01897038|Drug|Sorafenib|Sorafenib 400 milligram (mg) tablets (2 tablets of 200 mg each) orally once daily or twice daily depending on the cohort assigned until disease progression or unacceptable toxicity occurs (maximum up to 31 months).
16135035|NCT01897025|Device|real-tDCS with MI-BCI|As in Arm Description
16135036|NCT01897012|Drug|Alisertib|Given PO
16135037|NCT01897012|Other|Laboratory Biomarker Analysis|Correlative studies
16135038|NCT01897012|Drug|Romidepsin|Given IV
16135042|NCT01896973|Device|Vortx Rx - Histotripsy BPH Device|Non-invasive histotripsy treatment/therapy to be delivered by the surgeon using very low duty cycle ultrasound pulses from outside the patient's body. These pulses form a bubble cloud at the end of the focal area within the prostate which mechanically breaks up the cellular structure of the soft tissue. During treatment, a surgeon is able to direct the bubble cloud throughout the targeted volume using controls located on the device console and using the real-time ultrasound for visualization feedback and control of the bubble cloud location.
16135043|NCT01896960|Drug|Bupivacaine with 15 micrograms of fentanyl|Testing 2 doses of Bupivacaine (12.5 mg and 15 mg) with 15 micrograms fentanyl
16135044|NCT01896934|Drug|Sertraline|50-200mg daily
16135046|NCT01896908|Other|Sodium restriction|"Patients that are eligible and fulfill the inclusion criteria will be invited to participate while hospitalized, and then sign the informed consent form. Then, the dietitian on call will be notified in order to change the dietary map of the patients. The prescription diet for both the intervention and control group will be the same: DIET AS RESEARCH PROTOCOL. PATIENT WILL RECEIVE THE DIET UNTIL DAY __ / __ OR DISCHARGE. PLEASE DO NOT CHANGE IT. This will be combined with the medical staff and with the Nutrition and Dietetics service.
~The evaluation of outcomes after hospital discharge will be held in the institution of reference when will be performed clinical evaluation and blood samples collection for neurohormonal activation analysis."
16135047|NCT01896895|Drug|IncobulinumtoxinA (Xeomin), 25 Units|IncobotulinumtoxinA (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Main Period: 25 Units per eye.
16135048|NCT01896895|Drug|IncobotulinumtoxinA (Xeomin), 12.5 Units|IncobotulinumtoxinA (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl). Main Period: 12.5 Units per eye.
16135049|NCT01896895|Drug|Placebo|Main Period: Placebo to IncobotulinumtoxinA (Xeomin), powder for solution for injection, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
16135050|NCT01896895|Drug|IncobotulinumtoxinA (Xeomin), 35 Units|"IncobotulinumtoxinA (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl).
~Open-Label Extension: up to 35 Units per eye."
16135051|NCT01896882|Other|Sodium restriction|
16135052|NCT01896869|Drug|Ipilimumab|3 mg/kg administered IV (10mg/kg if treatment started prior to protocol v 6.3)
16135053|NCT01896869|Biological|Vaccine|5x10^8 cells administered in 6 intradermal injections
16135054|NCT01896869|Drug|FOLFIRINOX|Standard of care FOLFIRINOX may be modified according to the patient's known tolerability. Acceptable modified options could include 5-FU alone, capecitabine, FOLFOX, FOLFIRI, or FOLFIRINOX on a 21 day cycle.
16135055|NCT01896856|Drug|SGI-110 Dose Escalation|"Dose level 1 (DL1): 45 mg/m^2 administered as a subcutaneous injection
~Dose level 1G (DL1G): 45 mg/m^2 administered as a subcutaneous injection + growth factor support
~Dose level -1 (DL-1): 30 mg/m^2 administered as a subcutaneous injection
~Dose level -1G (DL-1G): 30 mg/m^2 administered as a subcutaneous injection + growth factor support"
16135056|NCT01896856|Drug|Regorafenib|160 mg taken orally
16135057|NCT01896856|Drug|TAS-102|35 mg/m^2 taken orally
16135058|NCT01896856|Drug|SGI-110|45 mg/m^2 administered as a subcutaneous injection
16135059|NCT01896856|Drug|Irinotecan|125 mg/m^2 administered IV
16135060|NCT01896843|Drug|STX107|
16135061|NCT01896830|Biological|Clostridium difficile Toxoid Vaccine|0.5 mL, intramuscular
16135062|NCT01896830|Biological|0.9% normal saline|0.5 mL, intramuscular
16135063|NCT01896791|Procedure|Transcranial Direct Current Stimulation|Active Transcranial Direct Current Stimulation : the anode electrode is placed in the area of the motor cortex M1 C3 or C4 position of the dominant hemisphere (International 10-20 EEG System). The cathode electrode is placed over the contralateral supraorbital region to the anode electrode. Treatment time and intensity of the stimulus: tDCS: 2 mili Ampere, 20min, 10 days.
16135064|NCT01896791|Procedure|Sham Stimulation|Sham Stimulation- appliance off during the entire period without active stimulation, with the position of the electrodes in the same sites of active stimulation
16135065|NCT01896778|Procedure|Hyperthermia Treatment|Undergo B-WARM
16135066|NCT01896778|Other|Laboratory Biomarker Analysis|Correlative studies
16135067|NCT01896765|Behavioral|Intensive Prevention Program|"Study nurse-coordinated education sessions, telephone calls, telephone hotline and telemetric care of cardiovascular risk factors (if patient internet connection available)."
16135068|NCT01896765|Other|Standard medical and interventional therapy|Medical and interventional therapy following the standard of care.
16135069|NCT01896739|Biological|Eutravac|
16135070|NCT01896726|Drug|Baricitinib|Administered orally
16135073|NCT01896700|Drug|Methylphenidate|Escalating dose of methylphenidate, 20mg, 40mg, 60mg/day, for 2 weeks each
16135074|NCT01896700|Drug|Placebo|Escalating matched dose of placebo
16135075|NCT01896687|Device|Scrambler|Electrotherapy
16135076|NCT01896661|Drug|Diuretics|Chlorthalidone plus amiloride 25 and 5 mg daily, taking in the morning
16135077|NCT01896661|Drug|Calcium Channel Blockers|Amlodipine 10 mg daily, taking in the morning
16135078|NCT01896635|Biological|FMT infusions|Active FMT derived from healthy anonymous pre-screened donors
16135079|NCT01896635|Other|Placebo infusion|Placebo infusion not containing any donor microbial material
16135080|NCT01896622|Drug|Ritonavir|Impact on dabigatran PK/PD
16135081|NCT01896622|Drug|Cobicistat|Impact on dabigatran PK/PD
16135082|NCT01896609|Biological|Reiferon Retard in Arm 1|Arm 1,2,3 Reiferon Retard® 160 µg /week subcutaneous injection for 48 weeks
16135083|NCT01896609|Drug|Bon one in Arm 3|Arm 3 , Bon One ® 0.5 µg daily orally for 48 weeks
16135084|NCT01896609|Drug|Xerovirinc in Arm 2|Arm 2,3 Xerovirinc® 500mg twice daily orally for 48 weeks
16135085|NCT01896609|Drug|Ribavirin in Arm 1|Arm 1,2,3 Ribavirin in a dose of 13 mg/kg/day orally for 48 weeks
16135086|NCT01896596|Biological|Menjugate|Administered with routine vaccinations at 3 months of age
16135087|NCT01896596|Biological|Menitorix|Administered with routine vaccinations at 3 months
16135088|NCT01896596|Biological|NeisVac-C|Administered with routine vaccinations at 3 months
16135089|NCT01896583|Drug|ASP7147|300 mg, tablet, twice per day for 4 weeks oral
16135090|NCT01896583|Drug|Placebo|
16135091|NCT01896570|Procedure|Catheter ablation of subsequent atrial tachycardia|
16135092|NCT01896557|Drug|omeprazole|Influence of omeprazole on clopidogrel pharmacodynamics will be evaluated.
16135093|NCT01896557|Drug|Ranitidine|Influence of ranitidine on clopidogrel pharmacodynamics will be evaluated.
16135094|NCT01896557|Drug|Clopidogrel|Clopidogrel added to ASA therapy at the first medical visit, Open label 75 mg once a day will be given to all individuals as part of the protocol (since main outcome of interest is clopidogrel effect. Actual comparison arms are double blind ranitidine and omeprazole
16135095|NCT01896544|Dietary Supplement|Cholecalciferol|7ml syringe of cholecalciferol suspension given through nasogastric (NG) or orogastric (OG) tube
16135096|NCT01896544|Dietary Supplement|Placebo|7ml syringe of placebo cholecalciferol suspension given through nasogastric (NG) or orogastric (OG) tube
16135097|NCT01896531|Drug|5-Fluorouracil|Participants will receive bolus and infusional 5-fluorouracil on Day 1 of each 14-day cycle (as a part of mFOLFOX6 therapy), until disease progression or unacceptable toxicity. The infusion times for infusional 5-fluorouracil may be determined per local and/or institutional standards and product labeling.
16135098|NCT01896531|Drug|Ipatasertib|Participants will receive ipatasertib, 600 milligrams (mg) orally once daily on Days 1 to 7 of each 14-day cycle until disease progression or unacceptable toxicity.
16135099|NCT01896531|Drug|Leucovorin|Participants will receive leucovorin or equivalent substitute orally, on Day 1 of each 14-day cycle (as a part of mFOLFOX6 therapy), until disease progression or unacceptable toxicity.
16135100|NCT01896531|Drug|Oxaliplatin|Participants will receive oxaliplatin via intravenous (IV) infusion on Day 1 of each 14-day cycle (part of mFOLFOX6 therapy). Oxaliplatin will be discontinued after completion of 8 cycles
16135101|NCT01896531|Drug|Placebo|Participants will receive matching oral placebo capsules once daily on Days 1 to 7 of each 14-day cycle until disease progression or unacceptable toxicity.
16135102|NCT01896518|Drug|Nicotine polacrilex|
16135103|NCT01896518|Drug|Tobacco lozenge|
16135104|NCT01896505|Drug|KCP-330|
16135105|NCT01896492|Drug|NAC|NAC 2gm plus cc 100mg from 3rd day of the cycle till day 8 with u/s follow up of the follicular growth.
16135106|NCT01896479|Drug|Cabozantinib (XL184) 140 mg|
16135107|NCT01896479|Drug|Cabozantinib (XL184) 60 mg|
16135108|NCT01896479|Drug|Placebo tablet|
16135109|NCT01896479|Drug|Placebo capsule|
16135110|NCT01896466|Device|Cranial Nerve Non-Invasive Neuromodulation|Portable device delivers electrical stimulation to cranial nerves V and VII via an electrode array placed on the anterior surface of the tongue. Stimulation is combined with rehabilitation exercises targeting walking and balance.
16135111|NCT01896466|Behavioral|Sham Cranial Nerve Non-Invasive Neuromodulation|Subjects participate in gait and balance rehabilitation exercises while using a device set to sub-threshold levels.
16135112|NCT01896453|Procedure|Transcranial direct current stimulation (tDCS)|Technique based on the application of weak, direct electrical current to the brain through relatively large electrodes that are placed over the scalp, in which anodal and cathodal stimulation increases and decreases cortical excitability, respectively
16135113|NCT01896453|Procedure|Transcutaneous electrical nerve stimulation (TENS)|Technique based on the application of low-voltage electrical current to the skin through relatively large electrodes that are placed over the pain area.
16135114|NCT01896440|Drug|Ondansetron|There will be two doses investigated in each arm - standard dose (0.15 mg/kg) and high dose (0.3 mg/kg)
16135115|NCT01896427|Drug|21-benzyloxy-9alpha-fluoro-16alpha-methylpregna-1,4-dien-11beta,17alpha-diol-3,20-dione|single dose of dexamethasone (8mg) will injected
16135116|NCT01896414|Dietary Supplement|EPA (marine fatty acids)|Subjects will be randomized to receive either EPA or placebo, four 1 gram capsules daily.
16135117|NCT01896414|Dietary Supplement|Placebo|Subjects will be randomized to receive either EPA/ or placebo, four 1 gram capsules daily.
16135118|NCT01896401|Device|InSeal's Vascular Closure Device|
16135119|NCT01896388|Drug|Ifenprodil Tartrate|
16135120|NCT01896388|Drug|Placebo|
16135121|NCT01896349|Other|IPT+ antidepressant drugs|16 sessions of interpersonal psychotherapy plus antidepressant drugs.
16135122|NCT01896349|Drug|fluoxetine|Antidepressant drugs, clinician´s free choice oriented by guidelines. Monotherapy or combinations are allowed
16135123|NCT01896349|Drug|sertraline|
16135124|NCT01896349|Drug|paroxetine|
16135125|NCT01896349|Drug|Citalopram|
16135126|NCT01896349|Drug|escitalopram|
16135127|NCT01896349|Drug|fluvoxamine|
16135128|NCT01896349|Drug|Venlafaxine|
16135129|NCT01896349|Drug|Duloxetine|
16135130|NCT01896349|Drug|Bupropion|
16135141|NCT01896336|Drug|Zolpidem Hemitartrate|"Patz - 5mg sublingual zolpidem hemitartrate
~1 QD
~Stilnox - 10mg oral zolpidem hemitartrate
~1 QD"
16135142|NCT01896323|Drug|CC-223|CC-223 20 mg tablets
16135143|NCT01896323|Drug|Ketoconazole|Ketoconazole 400 mg tablets
16135144|NCT01896310|Device|probe-based confocal laser endomicroscopy|all patients will receive pCLE examination
16135145|NCT01896297|Drug|Pradaxa, dabigatran etexilate|75mg BID by oral
16135146|NCT01896284|Drug|0.5mg aflibercept|0.5mg aflibercept intravitreal injection will be performed every 4 weeks from baseline to week 8 (3 doses) and every 8 weeks until week 32.
16135147|NCT01896271|Drug|IL-2|HD IL-2 (brand name Proleukin), 600,000 U/kg q8h X 14 dose, IV infusion
16135148|NCT01896271|Radiation|Stereotactic Ablative Body Radiation Therapy|SABR dose varying from 8Gy-20Gy in 1-3 fractions
16135149|NCT01896245|Drug|sevoflurane 1,0|anesthesia induction with propofol, remifentanil, and sevoflurane 1,0 MAC; afterwards tracheal intubation
16135150|NCT01896245|Drug|sevoflurane 1,2|anesthesia induction with propofol, remifentanil, and sevoflurane 1,2 MAC; afterwards tracheal intubation
16135151|NCT01896245|Drug|sevoflurane 1,4|anesthesia induction with propofol, remifentanil, and sevoflurane 1,4 MAC; afterwards tracheal intubation
16135152|NCT01896232|Drug|Etelcalcetide|Administered intravenously three times per week. The starting dose was 5 mg, titrated up to 15 mg based on serum PTH and corrected calcium levels.
16135153|NCT01896232|Drug|Cinacalcet|Cinacalcet was administered orally once a day. The starting dose was 30 mg daily, titrated up to 180 mg daily based on serum PTH and corrected calcium levels.
16135154|NCT01896232|Drug|Oral Placebo|Administered orally once a day.
16135155|NCT01896232|Drug|Intravenous Placebo|Administered intravenously (IV) three times per week.
16135156|NCT01896219|Device|Navigation station (IMACTIS-CT®)|
16135157|NCT01896219|Device|CT|Reference method for gestures (carried out under CT) guidance
16135158|NCT01896206|Device|CNAP monitor|Patients undergoing bariatric surgery and being monitored using the CNAP monitor.
16135159|NCT01896193|Drug|SOF|Sofosbuvir (SOF) 400 mg tablet administered orally once daily
16135160|NCT01896193|Drug|RBV|Ribavirin (RBV) tablets administered orally in a divided daily dose using weight-based dosing (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16135161|NCT01896180|Drug|ALZ-1101|ALZ-1101 Ophthalmic Solution
16135162|NCT01896180|Drug|Latanoprost|Latanoprost 0.005% Ophthalmic Solution
16135163|NCT01896167|Other|Hypoxia|Inhalation of hypoxic air (8-12% oxygen content)
16135164|NCT01896167|Other|Placebo|Inhalation of atmospheric air
16135165|NCT01896154|Dietary Supplement|NPS|Comparison of multiple dietary non-digestible polysaccharides
16135166|NCT01896128|Drug|Armodafinil|
16135167|NCT01896128|Drug|Placebo|inactive pill manufactured to mimic Armodafinil 150 mg tablet
16135168|NCT01896115|Device|Vercise DBS settings|Deep brain stimulation set at short pulse width and monopolar stimulation using current steering
16135169|NCT01896102|Genetic|Lenti-D Drug Product|Lenti-D Drug Product (autologous CD34+ cell-enriched population that contains cells transduced with Lenti-D lentiviral vector encoding human adrenoleukodystrophy protein, suspended in a cryopreservative solution) is administered intravenously. Lenti-D Drug Product is administered by IV infusion following myeloablative conditioning with busulfan and cyclophosphamide.
16135170|NCT01896076|Other|ultrasound evaluation of caudal space|"After induction of general anesthesia, the patients were placed in the lateral position. The ultrasound evaluation include transverse and longitudinal view.
~First, investigators place the transducer at the sacral cornua to obtain a transverse view.
~In the transverse view, the distance between two cornua and the depth of caudal space at the sacral hiatus were measured. In the longitudinal view, the distance from the skin to the sacrococcygeal membrane and the optimal angles and the safety distance for needle insertion depending on the points of insertions were measured. From the end of dura sac to the sacral hiatus were regarded as safety distance for the needle insertion during caudal block."
16135171|NCT01896063|Procedure|Electroacupuncture|
16135172|NCT01896050|Drug|anastrozole, letrozole, exemestane|Patients were treated with one of the listed anti-hormonal medications for up to one year
16135173|NCT01896050|Drug|Tamoxifen|Patients were treated with tamoxifen for up to one year
16135174|NCT01896037|Dietary Supplement|Omega-3 supplements|Daily omega-3 supplements of 600 mg EPA (Eicosapentaenoic acid) and 300 mg DHA (Docosahexaenoic acid) for 5 months.
16135175|NCT01896024|Behavioral|Psychiatric Management|
16135176|NCT01896024|Behavioral|Motive-oriented therapeutic relationship/Plan Analysis|
16135177|NCT01896011|Biological|Teriparatide 20 mcg|Teriparatide 20 mcg injection pen
16135178|NCT01896011|Other|Placebo|Placebo 20 mcg injection pen
16135179|NCT01895998|Drug|Albuterol|This medication will be used as routine part of pulmonary function testing to assess for airway hyperreactivity. This is routinely done in a clinical capacity for pediatric patients with various pulmonary disease processes.
16135180|NCT01895985|Drug|Latanoprostene bunod|
16135181|NCT01895972|Drug|Latanoprostene bunod|
16135182|NCT01895959|Drug|Euflexxa|Euflexxa will be injected weekly for 3 consecutive weeks on the knee joint.
16135183|NCT01895959|Device|Magnetic Resonance Imaging (MRI)|MRI of the knee will be acquired during baseline (a week prior to the treatment), follow up visit 1 (1 week after treatment) and follow up visit 2 (3 months after treatment).
16135184|NCT01895946|Drug|AZD5363|Oral AZD5363 twice daily, 4 days on 3 days off: tablet formulation for one week, followed by two weeks with capsule formulation.
16135185|NCT01895946|Drug|AZD5363|Oral AZD5363 twice daily, 4 days on 3 days off, tablet formulation. On day 4 AZD5363 tablet without food. On day 11 AZD5363 tablet with food.
16135186|NCT01895933|Device|5ml surgishield|"in the case of active, apply solution type adhesion barrier to merocel and pack 5ml of adhesion inhibitor Surgi Shield on the surgical site
~merocel in the inflated state maintained for 36~48 hours, remove packing then solution type adhesion inhibitor is to be injected in to the surgical site"
16135187|NCT01895920|Other|Blood sample|
16135188|NCT01895894|Drug|Mycophenolate mofetil|Mycophenolate mofetil 20~30mg/kg/day PO until nephrotic syndrome relapse (max. 1 year)
16135189|NCT01895881|Drug|Estradiol|
16135190|NCT01895881|Drug|Placebo|
16135191|NCT01895868|Other|Simulation-based ultrasound training|
16135192|NCT01895855|Biological|PXVX0200|Single dose; liquid suspension after reconstitution with buffer; 5x10^8
16135193|NCT01895855|Biological|placebo|
16135194|NCT01895842|Drug|Ruxolitinib|"Starting dose level for Part 1: 5 mg by mouth twice a day for a 28 day cycle.
~Starting dose level for Part 2: Maximum tolerated dose from Part 1."
16135195|NCT01895829|Procedure|Magnetic Resonance Imaging (MRI)|On Day 1, patient will have 2 standard MRIs, as part of standard of care. About an hour after these 2 scans, patient receives ferumoxytol by vein. Right after that, first study MRI performed. On Day 2, about 24 hours after patient receives ferumoxytol, second study MRI performed.
16135196|NCT01895829|Drug|Ferumoxytol|On Day 1, patient will have 2 standard MRIs, as part of standard of care. About an hour after these 2 scans, patient receives ferumoxytol by vein.
16135197|NCT01895816|Dietary Supplement|coated tablet|this supplement contains 700 mg of 8 natural herbals: Citrus & ZINGIBER OFFICINALE & Onion & Ocimum basilicum & Cinnamomum zelanicum & Citrullus lanatus & Citrullus vulgaris & Daucus carota
16135198|NCT01895790|Device|Pancreatic Duct Stent Placement|
16135199|NCT01895777|Drug|dabigatran etexilate|Age and weight appropriate capsule dose (combination of 50 mg, 75 mg and 110 mg capsules) or pellets or oral liquid formulation
16135200|NCT01895777|Drug|standard of care|Low molecular weight heparin, vitamin K antagonist or fondaparinux prescribed in an open label fashion for 3 months (these medications will not supplied in this study as IMP)
16135201|NCT01895764|Drug|Adalimumab|adalimumab, subcutaneous injection, 40mg every 2 weeks, week 0 until week 26
16135202|NCT01895764|Drug|Methotrexate|methotrexate, subcutaneous injection, 10mg per week, week -2 until week 26
16135203|NCT01895751|Procedure|Invasive management|Invasive management includes coronary and graft angiography (diagnostic imaging test) and coronary and/or graft revascularization with percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG), as clinically appropriate.
16135204|NCT01895738|Behavioral|WrapAround Care|Wraparound care is an established care model that starts with linking an individual with a support￼￼￼ worker who works with them to address risk factors and enable the individual to make positive choices. It is hypothesized that by working with youth to address the risk factors in their control, the likelihood of future violence is reduced.
16135205|NCT01895699|Other|Contrast agent|
16135206|NCT01895673|Other|Gadolinium|All patients will undergo PET-MRI additional to the PET-CT they routinely undergo. All patients will be administered Gadolinium for the PET-MRI scan. This is an extra intervention than they would normally undergo.
16135207|NCT01895660|Behavioral|Variations in Pediatric Constraint-Induced Movement Therapy (P-CIMT) versus usual and customary rehabilitation|Types of constraint and dosage amounts will be varied.
16135208|NCT01895647|Device|EMS|Electric muscle stimulation with programmed warm-up, stimulation and cool-down in 32 minutes
16135209|NCT01895634|Device|Rev-01|Treatment arm patients have used Rev-01 at least once
16135210|NCT01895621|Procedure|Median nerve decompression at the wrist|Surgical incision of the carpal ligament at the wrist and proximal hand to decompress the median nerve.
16135211|NCT01895621|Dietary Supplement|Alpha lipoic acid post median nerve decompression|Daily supplementation of alpha lipoic acid
16135212|NCT01895608|Behavioral|Balance rehabilitation + dual-tasking|Balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands with the addition of cognitive tasks, (e.g., counting backwards or reciting lists) to be added when the participant
16135213|NCT01895608|Behavioral|Standard balance rehabilitation|Standard balance rehabilitation will involve a structured framework of balance activities that require increasing levels of complexity and multimodal stimuli and response demands.
16135214|NCT01895608|Behavioral|Cognitive training (speed of processing)|Speed of processing cognitive training involves systematically increasing the complexity of visual tasks. Task demands are increased by reducing stimulus duration, adding visual or auditory distractors, increasing number of concurrent tasks or increasing the visual field.
16135215|NCT01895608|Behavioral|Cognitive training (general cognition)|General cognitive training involves systematic training of 14 key cognitive abilities, including visual scanning, response time, eye-hand coordination, spatial perception, and working memory. Initial starting point is determined by the software using baseline evaluation.
16135216|NCT01895595|Behavioral|Guided Imagery|
16135217|NCT01895595|Behavioral|Digital Storytelling|
16135218|NCT01895582|Other|Blood samples|"4 blood tubes of lithium heparinate (5ml) 3 blood tubes of QTF-G-IT (1ml)
~1 blood dry tube (5ml)"
16135219|NCT01895569|Drug|Metformin|Metformin will be added to therapy for the first threre months.
16135220|NCT01895569|Drug|Pioglitazone|In patients not well controlled (glycated hemoglobin >6.5%) after three months of metformin, pioglitazone will be added.
16135221|NCT01895569|Drug|Sitagliptin|In patients not well controlled (glycated hemoglobin >6.5%) after three months of metformin and pioglitazone, sitagliptin will be added.
16135222|NCT01895556|Other|Information|
16135223|NCT01895556|Other|Control|
16135224|NCT01895543|Drug|Elobixibat 10 mg|10 mg Elobixibat daily, with possibility for dose adjustment to 5 mg daily.
16135225|NCT01895530|Dietary Supplement|Saccharomyces boulardii|The patients received one oral lyophilized yeast capsule, each of which contains 100 mg (0,5 x 109 cfu/g) of Saccharomyces boulardii (Merck S.A., Biocodex, Beauvais, French), once a day. The treatment started at least seven days before surgery and stopped on the operation day.
16135226|NCT01895517|Other|LBC|Cervical cancer screening by using liquid based cytology as a standard screening modality
16135227|NCT01895517|Other|LBC plus HPV DNA testing|Cervical cancer screening by using liquid based cytology plus HPV DNA testing as an experimentally screening modality
16135228|NCT01895504|Device|ColoAssist|Screening colonoscopy with the test instrument
16135229|NCT01895504|Device|MEI|Colonoscopy with Olympus colonoscopes and MEI guidance
16135230|NCT01895491|Biological|VM206DNA|
16135231|NCT01895491|Biological|VM206Ad|
16135232|NCT01895478|Behavioral|PACCI-ED use|Attending physicians were allowed to view the patient's PACCI-ED prior to completing the assessment form. Attendings were told at the time of the child's ED visit that the PACCI-ED is used to assess a child's asthma control and medication adherence, and that they could use it to complete the outcomes assessment form.
16135233|NCT01895465|Device|Slitted diaper|A diaper where a slit is made through which a urine collection bag is pulled through
16135234|NCT01895452|Drug|ALKS 9072, Low Dose|Intramuscular injection, given monthly
16135235|NCT01895452|Drug|ALKS 9072, High Dose|Intramuscular injection, given monthly
16135236|NCT01895439|Biological|Autologous Mesenchymal Stem Cells|
16135237|NCT01895413|Procedure|Bone marrow aspiration|Single intra-articular injection of autologous bone marrow-derived mesenchymal stem cells by arthroscopy
16135238|NCT01895400|Drug|Renexin (cilostazol 100mg + gingko biloba extract 80 mg)|Take Renexin 1T bid po medication for 8 weeks
16135239|NCT01895400|Drug|Placebo|Take placebo drug 1T bid po medication for 8 weeks
16135240|NCT01895387|Dietary Supplement|Dietary intervention-whole grains and legumes|Subjects in the whole-grain group consumed replacing of refined rice intake with 1/3 of legumes, 1/3 of barley, and 1/3 of wild rice three times per day as a carbohydrate source and increased vegetable intake to at least 6 units (30-70 g/unit) per day for sufficient dietary fiber intake.
16135241|NCT01895387|Dietary Supplement|Dietary intervention-Refined rice|Subjects in the control group maintained their usual diet of refined rice
16135242|NCT01895374|Procedure|laser treatments|
16135243|NCT01895374|Other|amniotic membrane application|
16135244|NCT01895374|Device|hydrocolloid application|
16135245|NCT01895361|Drug|SelG1|
16135246|NCT01895361|Drug|Placebo|
16135247|NCT01895348|Drug|Propofol|Propofol TCI: effect-site concentration(Ce): Ce was titrated to 1.0 μg/ml and increased by 0.2 μg/ml every five minutes
16135248|NCT01895348|Drug|propofol-remifentanil|Propofol TCI: effect-site concentration(Ce): Ce was titrated to 1.0 μg/ml and increased by 0.2 μg/ml every five minutes Remifentanil TCI: effect-site concentration(Ce): Ce was titrated to 1.5 μg/ml
16135249|NCT01895348|Drug|Dexmedetomidine-remifentanil|Dexmedetomidine infusion: After the loading dose (1 mcg/kg for 10 minutes), the continuous infusion was done (0.2 mcg/kg/hr) and the infusion rate was increased by 0.2 mcg/kg/hr every five minutes (maximum infusion rate: 1.4 mcg/kg/hr) Remifentanil TCI: effect-site concentration(Ce): Ce was titrated to 1.5 μg/ml
16135250|NCT01895335|Drug|Teriflunomide|Pharmaceutical form: film-coated tablet; Route of administration: oral
16135251|NCT01895322|Drug|OPC-41061|
16135252|NCT01895309|Drug|Enbrel (etanercept)|
16135253|NCT01895309|Drug|SB4 (proposed biosimilar to etanercept)|
16135254|NCT01895296|Drug|Pasireotide|somatostatin analogue pasireotide
16135255|NCT01895296|Drug|Placebo|placebo s.c.
16135256|NCT01895283|Behavioral|Moderate-intensity training|Training at 70% of VO2max, for 1/2 hour, three times weekly, for 10 weeks, on a bike ergometer.
16135257|NCT01895270|Drug|Isradipine|Isradipine extended release formulation
16135258|NCT01895270|Drug|Placebo|Placebo will consist of microcrystalline cellulose.
16135259|NCT01895257|Device|HAI-90Y radioembolization (SIR-spheres injection)|"Patients randomised to receive the combination of SIR-Spheres microspheres plus systemic chemotherapy LV5FU2 need to be assessed in order to determine their suitability for SIRT.
~Hepatic Angiogram
~Liver-Lung Break-Through Nuclear Scan"
16135260|NCT01895257|Drug|systemic chemotherapy LV5FU2|"Systemic chemotherapy with modified LV5FU2 will be administered according to the following regimen.
~Cycle 1 onwards:
~Day 1 Hour 0: Leucovorin L (levoleucovorin) 200 mg/m2 (or folinic acid 400 mg/m²) in 250 ml glucose 5%, 2-hour IV infusion Hour + 2: 5-FU bolus 400 mg/m2, IV bolus Hour + 2: 5-FU continuous infusion 2400 mg/m2, 46-hour cont. IV infusion Day 14 End of cycle. To be repeated every 14 days until evidence of treatment failure."
16135261|NCT01895244|Drug|Autologous stemcell transplantation with CD (cluster of differentiation) 34 selected stem cells|If no active alveolitis: mobilisation with 2x1g Cyclophosphamide If active alveolitis: mobilisation with 2x1.5g Cyclophosphamid If cardiac manifestation: Conditioning with CYC 2 x 50mg + thiotepa 2x5mg + ATG If no cardiac manifestation: Conditioning with 4 x 50mg CYC + ATG
16135262|NCT01895231|Drug|Iron isomaltoside 1000 (Monofer®)|
16135263|NCT01895231|Drug|Placebo|
16135264|NCT01895218|Drug|Iron isomaltoside 1000|A single dose of 1200 mg iron isomaltoside 1000 is given. The dose is diluted in 100 ml 0.9 % sodium chloride and given over approximately 15 min.
16135265|NCT01895218|Other|Standard medical Care|Standard medical Care is most often to recommend women with PPH to continue oral iron supplementation as recommended during pregnancy or to advise the subject to take 100 mg oral iron 1-2 times a day
16135266|NCT01895205|Drug|Iron isomaltoside 1000|
16135267|NCT01895205|Drug|Red blood cell transfusion|
16135268|NCT01895192|Other|Assessment of sperm morphology (contrast microscopy).|Sperm head vacuoles were analyzed on 100 spermatozoa that were randomly photographed and separately analyzed using digital imaging system software. Interactive Measurement module allows measurement of sperm head areas and vacuole areas by manually depicting their outline. The area and position of each vacuole were recorded. Relative vacuole area is the ratio of the area of all the vacuoles of a spermatozoon to the area of its head.
16135269|NCT01895179|Other|Time-Restricted Feeding|Time-restricted feeding is a variant of intermittent fasting that involves eating all of one's calories within a few hours each day (typically 4-9 hours), followed by a daily fast of 15-20 hours.
16135270|NCT01895179|Other|Grazing|Grazing involves eating meals spread out over the course of the day.
16135271|NCT01895166|Procedure|EBUS-GS|EBUS is performed using an endoscope ultrasound system , which is equipped with a 20-MHz mechanical radial-type probe (UM-S20-17S;Olympus) with an external diameter of 1.4 mm and a GS (K-201; Olympus).
16135272|NCT01895166|Procedure|X-ray|The radiograph fluoroscopy are performed when the probe and GS are confirmed to reach the lesion by EBUS images ,cytologic and pathologic specimens are obtained under fluoroscopic guidance.
16135273|NCT01895140|Device|Renal denervation device|
16135274|NCT01895127|Drug|Eculizumab|
16135275|NCT01895127|Biological|Immunoglobulin|
16135276|NCT01895127|Procedure|Plasmapheresis|
16135277|NCT01895101|Drug|2 gr tranexamic acid|This group receives pericardial lavage with 2 gr tranexamic diluted in 200 ml normothermic saline solution (NaCl 0.9%).
16135278|NCT01895101|Drug|Saline|This group receives pericardial lavage with 200 ml normothermic saline solution without tranexamic acid
16135279|NCT01895088|Device|AcuFocus Corneal Inlay ACI 7000 PDT|Inlay implanted in cornea for improvement of near vision
16135444|NCT01893814|Dietary Supplement|Control|
16135280|NCT01895075|Drug|Inhaled budesonide|Inhaled budesonide 1 mg tid until 36 weeks' corrected gestational age or fully weaned from supplemental oxygen and respiratory support (CPAP or high flow nasal canula)
16135281|NCT01895075|Drug|Normal saline|2 ml normal saline by inhalation
16135282|NCT01895062|Device|Airway Management System (AMS)|"The AMS consists of a silicone collar applied under the mandible to the anterior surface of the neck.
~The collar is attached to a vacuum source which delivers continuous negative external pressure to the upper airway."
16135283|NCT01895049|Drug|Induction therapy with Thymoglobulin, prednisone, everolimus and late introduction of tacrolimus|
16135284|NCT01895049|Drug|Induction therapy with Thymoglobulin, prednisone, mycophenolate sodium and late introduction of tacrolimus|
16135285|NCT01895036|Drug|Naltrexone|
16135286|NCT01895023|Drug|Dexmedetomidine|The dexmedetomidine group received intranasal dexmedetomidine 2mcg/kg premedication 45 min before induction of anaesthesia.
16135287|NCT01895023|Drug|Midazolam|The midazolam group oral midazolam 0.5 mg/kg 30 min before induction of anaesthesia.
16135288|NCT01895023|Drug|Saline|The Placebo group received intranasal saline premedication 45 min and oral saline 30 min before induction of anaesthesia
16135289|NCT01895010|Device|acupoint electric stimulation|acupoint electric stimulation combined with tropisetron 6mg before TACE
16135290|NCT01895010|Drug|tropisetron|only tropisetron 6mg before TACE
16135291|NCT01894997|Device|Neuromuscular electrical stimulator|
16135292|NCT01894997|Device|AV Impulse System Model 6000|
16135293|NCT01894984|Drug|Risperidone|This is an observational study. Risperidone will be administered as intramuscular injection at a starting dose of either 25 milligram (mg) or 37.5 mg or 50 mg (starting dose will be decided on the basis of the disease severity), every two weeks, up to Week 24, wherein after Week 8, dose may be increased or decreased at physician discretion. For first three weeks, previous oral antipsychotic drug (Benzodiazepines or Selective serotonin reuptake inhibitor [SSRI]) will be maintained and will cease at Week 3.
16135294|NCT01894984|Drug|Oral atypical anti-psychotic|This is an observational study. Oral atypical anti-psychotic for example, olanzapine, risperidone, quetiapine etc will be administered as per Investigator's discretion.
16135295|NCT01894971|Device|The Effect of Ligasure® to Destroy Cornual Portion of Fallopian Tube|
16135296|NCT01894958|Drug|NNZ-2566|Glycyl-L-2-Methylpropyl-L-Glutamic Acid (NNZ-2566) supplied as a lyophilized powder (2g in 50mL vials or 3g in 30mL bottles) for reconstitution with strawberry flavored solution 0.5% v/v in Water for Injection.
16135297|NCT01894958|Drug|Placebo|Strawberry flavored solution
16135298|NCT01894932|Behavioral|Mindfulness-based cognitive Group therapy|In this study, groups of Mindfulness-based cognitive psychotherapy, will based on Segal, Williams & Teasdale (2002)'s work to redesigned an eight-week group course which adapted the local Taiwanese culture and add the appropriate revision of the content in a more easy to understand learning materials available to patient. The group would lead by 2 clinical psychologist and each session is about 2 hours.
16135299|NCT01894932|Behavioral|psycho-physiological stress regulation group|Physical and psychological stress regulation group in eight weeks, mainly to provide understanding of physical and mental effects of stress factors, self-conceptualization of stress and psychosomatic symptoms, physiological adjustment (relaxation, diet, exercise), psychological adjustment (positive primary, secondary assessment, cognitive identification), adjust negative thoughts, learn coping by using new choice. The group would lead by 2 clinical psychologist and each session is about 2 hours.
16135300|NCT01894919|Biological|Bexsero® vaccine (1 dose at study month zero)|
16135301|NCT01894919|Biological|Bexsero® vaccine (2 doses 1 month apart)|
16135302|NCT01894906|Drug|Soluble Ferric Pyrophosphate|
16135303|NCT01894906|Other|Placebo|
16135304|NCT01894880|Procedure|early SSC|bonding straight after birth
16135305|NCT01894880|Procedure|late SSC|bonding after termination of operation
16135306|NCT01894867|Dietary Supplement|magnesium|supply magnesium oxide for 6 weeks
16135307|NCT01894867|Dietary Supplement|Placebo|
16135308|NCT01894854|Procedure|Stem collar|The stem has two versions, one with and one without a collar. The classical Furlong HAC had a collar.
16135309|NCT01894841|Behavioral|Coping Long Term with Active Suicide (CLASP)|6 month behavioral telephone-based intervention. Calls assess risk, problem solve any immediate issues, and case management
16135310|NCT01894841|Other|Safety Assessment and Follow Up Evaluation|enhanced risk monitoring with full assessment protocol at 3, 6, 9, and 12 month follow up. Results sent as a note to the patient's VA mental health provider
16135311|NCT01894828|Dietary Supplement|Nutritional supplements|Patients are asked to drink two 200ml bottles of nutritional supplement daily for 14 days before surgery
16135312|NCT01894815|Drug|Escitalopram oxalate|The investigators will use 10mg and 20mg pills. The investigators will up-titrate escitalopram from 10 to 20mg/day according to the patient tolerability. The maximum dose (20mg/day) is sought to be achieved at week 3.
16135313|NCT01894815|Device|transcranial direct current stimulation|The anode will be applied over the F3 area and the cathode over the F4 area. The current dose is 2mA, current density is 0.8 A/m2. Electrodes will be 5x5cm in size. The investigators will apply 15 daily, consecutive tDCS sessions (excluding weekends) and after that one session per week until the primary endpoint.
16135314|NCT01894815|Other|Sham tDCS + Placebo Pill|This group receives sham tDCS and placebo pill.
16135315|NCT01894802|Device|Implantation of CRS Arrays|Two Blackrock Microsystems CRS Arrays will be implanted in the motor cortex and sensory cortex of study participants.
16135316|NCT01894789|Drug|Ticagrelor|Blinded administration of ticagrelor for 10 days
16135317|NCT01894789|Drug|Clopidogrel|Blinded administration of clopidogrel and placebo for 10 days
16135318|NCT01894776|Drug|Rifabutin|Substance: Rifabutin Daily dose: oral, 300 mg once daily (8:00 am) for 10 days
16135319|NCT01894776|Drug|Maraviroc|Substance maraviroc daily dose 300 mg twice daily (8:00 am and 8:00 pm) for 15 days
16135320|NCT01894763|Device|Self-expandable metal stent|Placement of a self-expandable metal stent in the esophagus
16135321|NCT01894750|Behavioral|group-based skill building self-care program|
16135322|NCT01894737|Other|Placebo supplementation|Seven days of one-legged knee immobilisation with placebo supplementation
16135323|NCT01894737|Other|Creatine supplementation|Seven days of one-legged knee immobilisation with creatine supplementation.
16135325|NCT01894711|Drug|Trastuzumab|Treatment with trastuzumab in HER2 positive patients
16135326|NCT01894685|Drug|Mesalazine|Mesalazine 3 grams, once daily for six months
16135327|NCT01894685|Drug|Placebo|Placebo 3 grams, once daily for six months
16135328|NCT01894672|Drug|LGX818|
16135329|NCT01894659|Other|24% oral sucrose|
16135330|NCT01894659|Other|30% oral glucose|
16135331|NCT01894646|Radiation|Positron Emission Tomography (PET) Imaging|
16135332|NCT01894633|Drug|Chloroquine|The patients in the Chloroquine group received 30 Gy of total brain radiotherapy in 10 daily fractions from Monday to Friday. Furthermore, the Chloroquine plus WBI arm received a daily single dose of 150 mg CLQ po 1 hour prior to the radiation treatment, beginning during the first radiotherapy fraction and continuing for 28 days
16135333|NCT01894633|Radiation|Total brain radiotherapy|30 Gy in 10 daily fractions from Monday to Friday
16135334|NCT01894620|Device|rTMS real-sham|In this intervention patients receive 4 weeks of rTMS treatment with real coil and then 4 weeks of treatment with sham coil; there will be 4 weeks of break between the two blocks of treatment.
16135335|NCT01894620|Device|rTMS sham-real|In this intervention patients receive 4 weeks of rTMS treatment with sham coil and then 4 weeks of treatment with real coil; there will be 4 weeks of break between the two blocks of treatment.
16135336|NCT01894607|Procedure|Contrast Enhanced Intraoperative Ultrasound|During standard of care surgery, radiologist will take images and videos with an ultrasound machine before and after patient given the contrast agent.
16135337|NCT01894607|Drug|DEFINITY|"During standard of care surgery, radiologist will take images and videos with an ultrasound machine before patient given the contrast agent.
~Patient then receives the DEFINITY contrast by vein over about 1 minute. After receiving the injection of DEFINITY, radiologist will take more images and videos of the tumor and kidney(s) to compare to those recorded earlier."
16135338|NCT01894607|Behavioral|Phone Call|Follow-up phone call 30 days after standard of care surgery is complete to review any side effects patient may be having.
16135339|NCT01894594|Drug|Sodium Bicarbonate|"Oral sodium bicarbonate tablets administered at a starting dose of 0.6 mEQ/Kg body weight and will be escalated once, at 4 weeks, to 0.9 mEQ/Kg body weight.
~Weekly schedule:
~0-4 weeks: Serial Measurement at baseline, without therapy 4-8 weeks: *~0.6 mEq/kg of ideal body weight of Sodium Bicarbonate tablets divided into TID dosing 8-12 weeks: *~0.9 mEq/kg of ideal body weight of Sodium Bicarbonate tablets divided into TID dosing
~* to the closest dose of 650 mg (7.74 mEq)
~Ideal Body Weight is defined by the following formulas (Devine Calculation):
~Ideal Body Weight (men) = 50 + 2.3 (Height (in) - 60) Ideal Body Weight (women) = 45.5 + 2.3 ( Height (in) - 60)"
16135340|NCT01894581|Dietary Supplement|LOVAZA|Subjects will be instructed to take 2 grams twice daily of oral omega-3-acid ethyl esters (Lovaza) starting with day 1 to 3 of their menstrual period. Each capsule contains 60mg of other omega-3 FA. On day 1 of their subsequent menstrual period, subjects will be instructed to discontinue.
16135341|NCT01894581|Drug|GnRH|An intravenous bolus of exogenous GnRH (75 ng/kg dosing based on total body weight) will be administered at 6 hours.
16135342|NCT01894568|Drug|Insulin Peglispro|Administered SC using a prefilled pen.
16135343|NCT01894568|Drug|Insulin Glargine|Administered SC using a prefilled pen
16135344|NCT01894568|Drug|Oral Antihyperglycemic Medications (OAMs)|Administered orally
16135345|NCT01894555|Drug|Aspirin|81 mg daily for 4 weeks
16135346|NCT01894542|Dietary Supplement|Cod protein from presscake|6g protein per day for 8wk
16135347|NCT01894542|Dietary Supplement|Cod protein from presscake + stickwater|6 g protein per day for 8 wk
16135348|NCT01894542|Dietary Supplement|Control|
16135349|NCT01894516|Drug|GLPG0634|GLPG0634 capsules.
16135350|NCT01894516|Drug|Placebo|Placebo capsules.
16135351|NCT01894503|Drug|S8 Sinus Implant (mometasone furoate, 1350 mcg)|Bioabsorbable sinus implant with 1350 mcg of mometasone furoate released over 90 days
16135352|NCT01894477|Procedure|Allogeneic Bone Marrow Transplantation|Undergo allogeneic bone marrow transplant
16135353|NCT01894477|Drug|Fludarabine Phosphate|Intravenously administered Fludarabine Phosphate
16135354|NCT01894477|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo allogeneic PBSC transplant
16135355|NCT01894477|Radiation|Total-Body Irradiation|Undergo TBI
16135356|NCT01894477|Drug|Treosulfan|Intravenously administered Treosulfan
16135357|NCT01894477|Other|Laboratory Biomarker Analysis|Correlative Studies
16135358|NCT01894464|Behavioral|Teacher led intervention|
16135359|NCT01894451|Drug|89Zr-bevacizumab|89Zr-bevacizumab is a newly developed radiotracer. Radiotracers are compounds or drugs that are attached to small amounts of a radioactive substance. The amount of the compound or drug in a radiotracer is also very small. Radiotracers are used to make images of processes that are happening in the body, but they do not affect how the body works. 89Zr-bevacizumab is made up of the drug bevacizumab and the radioactive substance zirconium-89 (89Zr). 89Zr-bevacizumab is used for an imaging procedure called positron emission tomography/computed tomography (PET/CT). 89Zr-bevacizumab-PET/CT will be performed in this study at baseline, after 2 cycles of preoperative chemotherapy and at the completion of chemotherapy.
16135360|NCT01894451|Procedure|FDG-PET/CT|FDG-PET/CT scan: Pictures of your organs will be taken using a PET (Positron Emission Tomography) scanner. At the same time, a CT (computed tomography) scan will be performed. FDG, a radioactive substance similar to glucose (or sugar), will be injected into your vein using a needle prior to performing the PET/CT scan. After the injection, you will be asked to sit quietly for one hour to let the FDG absorb into the body. After this hour, you will be asked to lie flat on your back for up to 50 minutes while the PET and CT images are being taken. This FDG-PET/CT scan is part of regular cancer care. If you have had this test within 14 days of study enrollment, you may or may not have to have this test repeated.
16135361|NCT01894451|Procedure|MRI scan|• MRI Scan: MRI (Magnetic Resonance Imaging) scans of the breast will be taken. You will receive an injection of a dye before the MRI. You will be asked to lie flat on your back in the scanner for up to 30 minutes for pictures to be taken. This MRI scan is part of regular cancer care. If you have had this test within 14 days of study enrollment , you may or may not have to have this test repeated.
16135445|NCT01893801|Drug|nab-paclitaxel|25 mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle
16135446|NCT01893801|Drug|Cisplatin|25mg/m2 (or 50mg/m2) given intravenously (IV) on days 1 and 8 of a 21 day cycle
16135816|NCT01890876|Other|Walking downhill|descending about 500 m
16135362|NCT01894451|Procedure|Tumor biopsies|Tumor biopsies: Prior to starting your treatment, a radiologist will use breast MRI or ultrasound imaging to localize an area of your tumor in the breast for a research biopsy. The biopsy procedure is done in an outpatient setting using a done using a needle to obtain tissue. A local anesthetic will be given to minimize any pain; however, after the procedure you can expect some discomfort and possible bruising. This biopsy is part of research.
16135363|NCT01894438|Behavioral|Mediterranean lifestyle|Counseling will be based on the goal setting theory. Motivational and behavioral strategies will be also used. In the Mediterranean lifestyle group culinary practices, seasonality, and locality of food products, socialization during meals, rest during the day, as well as the adoption of an active living will be additionally addressed.
16135364|NCT01894438|Behavioral|Mediterranean Diet|Counseling will be based on the goal setting theory. Motivational and behavioral strategies will be also used. In the Mediterranean diet group, all food groups of the Mediterranean diet will be targeted.
16135365|NCT01894412|Biological|Etanercept (Enbrel)|
16135366|NCT01894412|Biological|HD203|
16135367|NCT01894399|Drug|HM61713|Cohort 1 : 100mg single dose in Korean Cohort 2 : 200mg single dose in Korean Cohort 3 : 300mg single dose in Korean Cohort 4 : 200mg single dose in Japanese Cohort 5 : 300mg single dose in Japanese Cohort 6 : 200mg single dose in Caucasian Cohort 7 : 300mg single dose in Caucasian
16135368|NCT01894386|Drug|FF 400 mcg|100 mcg powder for inhalation delivered by Dry Powder Inhaler (DPI)
16135369|NCT01894386|Drug|UMEC 500 mcg|125 mcg powder for inhalation delivered by DPI
16135370|NCT01894386|Drug|UMEC 250 mcg|62.5 mcg powder for inhalation delivered by DPI
16135371|NCT01894386|Drug|VI 100 mcg|25 mcg powder for inhalation delivered by DPI
16135372|NCT01894373|Drug|Adoptive Immunotherapy|Biological: in vitro expanded Cytokine Induced Killer (CIK) cells Procedure: Infusion of autologous CIK cells
16135373|NCT01894373|Biological|CIK|
16135374|NCT01894360|Drug|Belimumab 200 mg/mL|Clear to opalescent, colorless to pale yellow sterile solution sterile solution for SC injection in a single-use liquid formulation of Belimumab 200 mg/mL will be supplied in 1mL long glass prefilled syringe or autoinjector device.
16135375|NCT01894347|Other|TDM, Monitoring of Neuro-and Nephropathology|Therapeutic drug monitoring of serum levels and Monitoring of Neuro- and Nephropathology
16135376|NCT01894334|Drug|Ulinastatin|
16135377|NCT01894334|Drug|Tranexamic acid|
16135378|NCT01894334|Drug|Edaravone|
16135379|NCT01894308|Drug|Testosterone|10,30,50 and 70 mg doses of micronized Testosterone delivered by means of a new liquid transdermal delivery solution, HypoSpray(R)once daily for 7 days or until halted due to systemic or dermal reactions.
16135380|NCT01894295|Dietary Supplement|Placebo|Corn oil pearl Capsules 1 gram; were given to the intervention group once a day for 8 weeks
16135381|NCT01894295|Dietary Supplement|Vitamin D analogue|1-α hydroxyvitamin D3 dose 0.25, 0.5 and 1 microgram were given to the intervention group once a day for 8 weeks
16135382|NCT01894282|Procedure|Manual Therapy|Manual Therapy Arm
16135383|NCT01894282|Procedure|Mind Body Intervention|Combination of manual therapy and cognitive behavioral therapy for pain.
16135384|NCT01894269|Drug|Lamivudine 100mg once daily; or Entecavir 0.5mg once daily.|In experimental group, Lamivudine 100mg once daily; or Entecavir 0.5mg once daily will be commenced after TACE.
16135385|NCT01894256|Drug|Olaparib tablet dosing|Part A - single 300mg oral dose olaparib (administered as 2x150mg tablets) Part B - 300mg oral dose olaparib (administered as 2x150mg tablets) bd
16135386|NCT01894243|Drug|Olaparib tablet dosing|Part A - single 300mg oral dose olaparib (administered as 2x150mg tablets) Part B - 300mg oral dose olaparib (administered as 2x150mg tablets) bd
16135387|NCT01894230|Genetic|SLCO1B1*5 allele testing, results reported at randomization|Genetic testing for SLCO1B1*5 allele and reporting of results to patient and provider at randomization
16135388|NCT01894230|Genetic|SLCO1B1*5 allele testing, results reported at end of study|Genetic testing for SLCO1B1*5 allele and reporting of results to patient and provider at end of study
16135389|NCT01894230|Genetic|Genetic testing for SLCO1B1*5 allele|Blood test for SLCO1B1*5 allele
16135390|NCT01894217|Genetic|Genetic testing and reporting for SLCO1B1*5 allele|Blood test for SLCO1B1*5 allele; reporting of test results to provider and participant
16135391|NCT01894204|Other|HTPPE|No drug and no placebo were used in this study. Some exams must be performed (DLCO - evaluation of the dyspnoea and pulmonary scintigraphy), and in function of the result of the pulmonary scintigraphy, the medical care of the patient will be different : negative pulmonary scintigraphy, stop of the explorations and taken care usual of the patients; positive pulmonary scintigraphy,realisation of a cardiac echography to estimate the presence or not of a not very probable, possible or likely HTP. The indication of the right cardiac catheterization is then put on the combination of the results of the cardiac echography and the evaluation of the dyspnoea.
16135392|NCT01894191|Procedure|Air insufflation|Insufflation during colonoscopy including insertion phase
16135393|NCT01894191|Procedure|water immersion|Water will infused during insertion phase and removed during withdrawal phase of colonoscopy
16135394|NCT01894191|Procedure|Water exchange|Water will infused and removed during insertion phase of colonoscopy
16135395|NCT01894178|Device|Parker Flex-Tip® tracheal tube|
16135396|NCT01894178|Device|Portex® Tracheal Tube|
16135397|NCT01894165|Drug|ALXN1101|Randomized to receive a single dose of ALXN1101 or placebo as per assigned cohort dose level.
16135398|NCT01894165|Drug|Placebo|Randomized to receive a single dose of ALXN1101 or placebo as per assigned cohort dose level.
16135399|NCT01894152|Device|XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)|Subjects receiving XIENCE PRIME Everolimus Eluting Coronary Stent System (EECSS)
16135400|NCT01894139|Other|High-Protein/Low-GI Diet|
16135401|NCT01894139|Other|Low-protein/High-GI Diet|
16135402|NCT01894126|Behavioral|Two-way SMS Dialogue|
16135403|NCT01894126|Behavioral|One-way SMS Messaging|
16135404|NCT01894113|Procedure|transbronchial lung biopsy|
16135447|NCT01893801|Drug|gemcitabine|1000mg/m2 given intravenously (IV) on days 1 and 8 of a 21 day cycle
16135448|NCT01893788|Drug|Aliskiren|Aliskiren: 150 to 300 mg daily for 48 weeks
16135449|NCT01893788|Drug|Eplerenone|50 to 100 mg daily for 48 weeks
16135814|NCT01890889|Other|Defatted egg yolk without the active ingredient of the other two interventions|
16135405|NCT01894100|Device|Shoe lift correction for leg length inequality|Lift therapy will be administered by a physical therapist. Heel lifts and full length inserts used inside participants' shoes will be constructed on-site. If an external shoe lift is required for a participant, a local shoe repair shop will construct the lifts and add them to the outside of the shoe. Participants will be required to wear the lift in their shoes when they are walking or standing while enrolled in the study; participants will keep a daily diary to record their compliance (number of hours lift worn per day, amount of lift used, type of shoes worn, general symptoms experienced, and activities performed). They will be contacted weekly to be reminded to increase their lift height and identify when they have achieved their optimal lift height.
16135406|NCT01894087|Behavioral|TBI - Cohort 1|
16135407|NCT01894087|Behavioral|TBI - Cohort 2|
16135408|NCT01894074|Behavioral|Intensive Dietary Intervention|Intensive dietary intervention of 800 kcal/day using liquid meal replacement for a total of 12 weeks to reduce weight to 15% from baseline weight.
16135409|NCT01894074|Behavioral|Placebo|Lifestyle counseling: standard dietary education and counseling with a goal of reducing to 1500-1800 kcal/day
16135410|NCT01894061|Biological|Bevacizumab|Bevacizumab will be administered intravenously on days 1 and 15 of each 28 day cycle. The dose of bevacizumab will be 10 mg/kg of actual body weight.
16135411|NCT01894061|Device|NovoTTF-l00A|NovoTTF-100A will be worn continuously.
16135412|NCT01894061|Other|Quality of Life Assessment|Functional Assessment of Cancer Therapy including Brain Tumor module (FACT-Br) questionnaire
16135413|NCT01894048|Drug|Qvar® (beclometasone dipropionate HFA)|Participants will be converted to Qvar (HFA-beclometasone) at an equivalent therapeutic dose to their original inhaled corticosteroids. The treatment duration will for 8 weeks after a run-in period.
16135414|NCT01894035|Drug|Iloprost (Ventavis, BAYQ 6256)|Patients Diagnosed with Pulmonary Arterial Hypertension, Functional Class NYHA/WHO III, for whom was prescribed inhaled Iloprost.
16135415|NCT01894022|Drug|Ambrisentan 5 mg|Round, white, film-coated, immediate-release tablets, containing 5 mg ambrisentan. Subjects will be dosed orally once daily. Subjects may receive 5mg, or 10 mg of ambrisentan OD.
16135416|NCT01894009|Procedure|Foot manipulation|The subtalar joint was treated with gapping thrust with patient lying on the contra-lateral side. Mobilisation of the distal tibia-fibula was performed with the patient squatting and was repeated 10 times. Home training programs in order to maintain the mobility in the joints were given.
16135417|NCT01894009|Procedure|Sham foot manipulation|Sham manipulation included downsizing (a massage technique) the section underneath the heel from back forwards with four grips and palpation of the five metatarsal bones. Sham manipulations were repeated 10 times. This group was also recommended home exercises in the mornings.
16135418|NCT01893996|Drug|Adalimumab|Patients will be randomized 1:1 to receive either adalimumab or placebo for the first 26 weeks of the trial, and then after a 26 week washout period, will be crossed over into the other arm (either placebo or adalimumab) for weeks 52-78.
16135419|NCT01893996|Drug|Placebo|
16135420|NCT01893983|Behavioral|Motivational Coaching|Telephone-based Motivational Interviewing aimed at getting Veterans to engage or retain mental health treatment
16135421|NCT01893970|Behavioral|SWIFT|Participants will receive: 1) acute social work intervention for adults with mTBI, including early education, reassurance, resources and brief alcohol intervention in the ED (SWIFT-Acute) and 2) follow up telephone counseling, needs assessment and case management referral to necessary services (SWIFT).
16135422|NCT01893970|Behavioral|SWIFT-Acute|acute social work intervention for adults with mTBI, including early education, reassurance, resources and brief alcohol intervention in the ED (SWIFT-Acute)
16135423|NCT01893957|Procedure|high voltage electrical stimulation - axillary lymphadenectomy|Will be used high voltage electrical stimulation, Neurodyn High Volt Model (IBRAMED), twice a week, over the course of seven weeks,in 20-minute sessions on alternate days. The parameters are: high voltage pulsed current, monopolar (cathode), 100 Hz, synchronized mode, on/off relationship of 3:9 seconds, rise/decay 2:1 seconds, and motor threshold. The electrodes are positioned in the middle and distal thirds of the anterior surface of the forearm and arm.
16135424|NCT01893957|Procedure|High voltage electrical stimulation - ( healthy women )|Will be used high voltage electrical stimulation, Neurodyn High Volt Model (IBRAMED), twice a week, over the course of seven weeks,in 20-minute sessions on alternate days. The parameters are: high voltage pulsed current, monopolar (cathode), 100 Hz, synchronized mode, on/off relationship of 3:9 seconds, rise/decay 2:1 seconds, and motor threshold. The electrodes are positioned in the middle and distal thirds of the anterior surface of the forearm and arm.
16135425|NCT01893957|Device|Neurodyn High Volt Model (IBRAMED)|
16135426|NCT01893944|Other|virtual reality|customized applications using virtual and augmented reality to be developed.
16135427|NCT01893931|Behavioral|ED Discharge & Medication Call|Patients will receive a follow up phone call from a nurse to review discharge instructions and provide any necessary patient navigation.
16135428|NCT01893931|Behavioral|Placebo Comparator|
16135429|NCT01893905|Drug|CS+SG|Chondroitin sulfate+glucosamine sulfate orally administered once a day for 24 weeks.
16135430|NCT01893905|Drug|Placebo|Placebo of chondroitin sulfate+glucosamine sulfate orally administered once a day for 24 weeks.
16135431|NCT01893892|Dietary Supplement|levocarnitine|Given PO
16135432|NCT01893892|Other|placebo|Given PO
16135433|NCT01893892|Other|questionnaire administration|Ancillary studies
16135434|NCT01893879|Drug|placebo for study drug|Given PO
16135435|NCT01893879|Drug|(RS)2-(3-benzoylphenyl)-propionic acid|Given PO
16135436|NCT01893879|Other|laboratory biomarker analysis|Correlative studies
16135437|NCT01893866|Drug|1 x 30 mg/mL pegvisomant|Subcutaneous injection, 30 mg, single dose.
16135438|NCT01893866|Drug|2 x 15 mg/mL pegvisomant|Subcutaneous injection, 2 injections of 15 mg, single dose.
16135439|NCT01893853|Other|Exercise Intervention|Exercise intervention trials will consist of a steady-state bout of exercise at ~70% VO2peak and a timed performance test on a cycle ergometer in a heated environment.
16135440|NCT01893840|Device|FlowOx|Boot-shaped pressure chamber generating pulsating negative pressure
16135441|NCT01893827|Drug|XR-NTX (Extended-Release Naltrexone)|380mg (4cc) XR-NTX administered by IM injection 1x/month for 6 months.
16135442|NCT01893827|Drug|Oral Naltrexone (O-NTX)|50mg pill form of naltrexone taken 1x/day for 6 months.
16135450|NCT01893775|Biological|Hu-Mik- Beta-1|Hu-Mik-Beta-1 every 3 weeks for a total of 3 doses (given on day 1, week 3 and week 6)
16135451|NCT01893762|Biological|Aerobic exercise|Aerobic exercise: 2x30 min on an indoor rowing machine at 75% of Maximum heart rate
16135452|NCT01893762|Biological|Anaerobic exercise|Anaerobic exercise: 3x1000m maximum effort, on an indoor rowing machine
16135453|NCT01893749|Behavioral|CATCH-IT|It contains 14 modules focused on behavioral activation, cognitive behavioral therapy, interpersonal therapy and a resiliency building model, including elements such as narratives, video diaries, skill building exercises and a booster program (not yet initiated) with 6 modules that involves interaction with a live therapist. It also includes three 15-minute meetings with the primary care provider at baseline, 2 months and 12 months post intervention. These meetings are focused on the motivational interview approach where the patient and the doctor talk about the mental/physical health goals of the patient and determine the best approach for the patient by allowing the patient to have full input into the plan.
16135454|NCT01893736|Other|In-hospital professional support|In-hospital professional lactation support will consist of two 30-minute one-to-one hands-on breastfeeding counseling sessions in first 24 hours post-partum and one further 30-minute one-to-one hands-on breastfeeding counseling session on the second day of post-partum hospitalization for a total of three 30-minute sessions. The one-to-one sessions will focus on: (1) education and advice on correct breastfeeding positions and techniques, (2) education and advice on milk supply and how to avoid common breastfeeding problems, and (3) hands-on instruction and assistance with proper breastfeeding positioning and technique, latching on and newborn attachment to the breast, and manual expression of breast milk.
16135455|NCT01893736|Other|Postpartum telephone follow-up support|Postpartum telephone follow-up support will consist of telephone support 72 hours after hospital discharge and weekly for the first 4 weeks, or until weaned. Earlier telephone contacts will focus more on breastfeeding topics. Information will be solicited from the participants about problems or difficulties they are experiencing. Supportive advice will be provided regarding management of breastfeeding problems, and support and encouragement for the continuation of breastfeeding. Later contacts will focus more on advice and encouragement on breastfeeding while resuming daily activities or returning to work, nursing in public places, and expressing and storing breast milk.
16135456|NCT01893723|Procedure|ANI guided remifentanil|remifentanil administration during propofol anesthesia for laparoscopic surgery is ANI guided
16135457|NCT01893723|Procedure|ANI blind arm|remifentanil administration during propofol anesthesia for laparoscopic surgery is not ANI guided
16135458|NCT01893710|Procedure|biopsy sampling|"Two parietal peritoneal samples, each 1 cm² x 0.3 cm in depth and three omental tissue samples, each 1 cm² in size will be obtained.
~Biopsy sampling will be performed in all groups. This is an observational not an interventional trial."
16135459|NCT01893697|Other|HRCT scan in a specific postural position|HRCT Scan taken in supine and lateral position
16135460|NCT01893684|Behavioral|Exercise|PRO+EX and CARB+EX groups will be prescribed an exercise program with required attendance of 3 nonconsecutive days per week. Exercise sessions will be supervised and conducted by trained graduate students in the Department of Kinesiology. Based on recommended practice, a program that combines flexibility and balance activities, weight bearing endurance exercise (walking) and resistance training to preserve lean mass will be prescribed. Each session will last ~75 min with a 35 min warm-up/aerobic exercise of mild to moderate intensity, ~30 min of resistance training, and finally, a ~10 min of balance and flexibility exercises during the cool-down period. Endurance training activities will vary but will all be weight-bearing.
16135461|NCT01893684|Behavioral|Higher Protein Diet|PRO diet recommendations will include high quality proteins with an emphasis on lean meats with protein being targeted for every meal and snack. PRO will provide dietary protein (1.6 g.kg-1.d-1; ~30% of energy intake) with a ratio of carbohydrate/protein of <1.5 and dietary lipids at ~ 30% energy intake. Energy deficit will be determined by reducing estimated daily energy needs by ~500 kcal/d. Regarding beef intake specifically, the prescribed diet will include a minimum of one serving of beef per day, which is approximately 3 to 3.5 ounces or ~100 grams. This amount of lean cooked beef provides an average of ~25-30 grams of protein per day (www.beefnutrition.org/leanbeef.aspx). Our dietary prescription to the PRO groups that they add 3 ounces (and perhaps up to 3.5 ounces pending body size) of lean beef daily will provide an additional 25-30 grams of protein. This diet will also include 5 servings/day of vegetables and 2-3 servings/day of fruit.
16135462|NCT01893684|Behavioral|Conventional Carbohydrate Diet|For the CARB group, the diet will provide dietary protein at 0.8 g.kg-1.d-1 (~ 18% of energy intake) with a ratio of carbohydrates/protein > 3.5 and dietary lipids at ~ 30% energy intake. Through nutrition education and counseling we will ensure that the CARB group meets the RDA for protein for women of 46 grams per day from a variety of plant and animal sources. Again, energy deficit will be determined by reducing estimated daily energy needs by ~500 kcal/d. Additional recommendations will include 5 servings/day of vegetables and 2-3 servings/day of fruit. Beef intake will be discouraged in the CARB group.
16135463|NCT01893658|Drug|Omalizumab|administration of a single dose together with the standard treatment
16135464|NCT01893658|Drug|Prednisone|standard treatment
16135465|NCT01893645|Device|Pronto-7|A new point-of-care pulse co-oximeter that offers a non-invasive and quick spot-checking of Hb (SpHb).
16135466|NCT01893632|Drug|gabapentin|
16135467|NCT01893632|Drug|Placebo|
16135468|NCT01893606|Drug|N-acetyl-D-glucosamine|
16135469|NCT01893606|Drug|placebo|
16135470|NCT01893593|Other|Intervention|Guideline summary and data feedback from a baseline medical record review and a multifaceted intervention to improve clinical systems
16135471|NCT01893593|Other|Control|Guideline summary and data feedback from a baseline medical record review
16135472|NCT01893580|Behavioral|Experimental: 1. Experimental|"Home-based exercise pre surgery and postoperative exercise in a team initiated two weeks after surgery. Intervention consists of:
~Preoperative home-based exercise program - cardiovascular exercise of moderate-vigorous intensity for at least 30 minutes every day until surgery.
~Postoperative rehabilitation: A supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions and smoking cessation, nutritional counseling or patient education, this is offered too.The cardiorespiratory intensity is at ~50-60% of individual HRmax for the first four weeks and increases to moderate-high intensity at ~70-90% of individually determined HRmax. The intensity of the strength exercise program is at ~60-80% of 1 RM."
16135809|NCT01890915|Other|Heat Exposure|Heat exposure of 95 degrees F for up to 2 hours.
16135473|NCT01893580|Behavioral|Experimental: 2. Experimental|"Home-based exercise pre surgery and postoperative exercise in a team initiated six weeks after surgery. Intervention consists of:
~Preoperative home-based exercise program - cardiovascular exercise of moderate-vigorous intensity for at least 30 minutes every day until surgery.
~Postoperative rehabilitation: A supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions and smoking cessation, nutritional counseling or patient education, this is offered too.The cardiorespiratory intensity is at ~50-60% of individual HRmax for the first four weeks and increases to moderate-high intensity at ~70-90% of individually determined HRmax. The intensity of the strength exercise program is at ~60-80% of 1 RM."
16135474|NCT01893580|Behavioral|Experimental: 3. Experimental|"Early postoperative exercise in a team initiated two weeks after surgery. Intervention consists of:
~Postoperative rehabilitation: A supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions and smoking cessation, nutritional counseling or patient education, this is offered too.The cardiorespiratory intensity is at ~50-60% of individual HRmax for the first four weeks and increases to moderate-high intensity at ~70-90% of individually determined HRmax. The intensity of the strength exercise program is at ~60-80% of 1 RM."
16135475|NCT01893580|Behavioral|Other: 4. Usual care|"Exercise in a team initiated six weeks after surgery consisting of a supervised 12-week rehabilitation program containing 24 group-based exercise sessions, three individual counseling sessions, and three group-based lessons in health-promoting behavior. If the participants have special needs in terms of smoking cessation, nutritional counseling or patient education, this is offered too.
~The cardiorespiratory intensity is at ~50-60% of individual HRmax for the first four weeks. The next eight weeks the intensity increases to moderate-high intensity at ~70-90% of individually determined HRmax. The intensity of the strength exercise program is at ~60-80% of 1 RM."
16135476|NCT01893567|Drug|Clobex Spray|
16135477|NCT01893554|Biological|RSV ΔNS2 Δ1313 I1314L Vaccine|"For participants in Groups 1, 3, and 4: 10^6 plaque forming units (PFU) of RSV ΔNS2 Δ1313 I1314L vaccine will be administered as nose drops (0.25 mL per nostril for a total of 0.5 mL).
~For participants in Group 2: 10^5 PFU of RSV ΔNS2 Δ1313 I1314L vaccine will be administered as nose drops (0.25 mL per nostril for a total of 0.5 mL)."
16135478|NCT01893554|Biological|Placebo|Placebo will be administered as nose drops (0.25 mL per nostril for a total of 0.5 mL).
16135479|NCT01893541|Procedure|ENDOSCOPIC BAND LIGATION|The procedures will be performed using standard technique with a multiband ligation device. Elastic bands will be placed according to physician decision, starting at esophagogastric junction. All varices will be treated during the same session. Endoscopic band ligation sessions will be repeated at intervals of 3 to 4 weeks until all varices will be obliterated.
16135480|NCT01893541|Drug|PROPRANOLOL|The initial propranolol dose will be orally BID 40 mg, irrespective of patient's weight. The objective of the administration of propranolol will be induce beta-adrenergic blockade evaluated by reduction in heart rate to 55 bpm or a 25% drop in baseline heart rate. A baseline electrocardiogram will be obtained from all patients. The doses will be adjusted during weekly visits until beta-adrenergic blockade. After the adequate dose will be reached, the visits will be scheduled monthly during the first 3 months (until EV eradication) and then at a 3-month interval until the end of follow-up.
16135481|NCT01893541|Device|a multiband ligation device|
16135482|NCT01893528|Drug|REGN2009|
16135483|NCT01893528|Other|placebo|
16135484|NCT01893515|Drug|PRC-4016|
16135485|NCT01893515|Drug|Placebo|
16135486|NCT01893502|Behavioral|Telephone counselling from Quitline|
16135487|NCT01893489|Other|68Gallium-MSA|68Gallium-MSA 2.0 mci for Positron Emission Tomogram(PET) imaging
16135488|NCT01893476|Other|Implementation educational programme|Implementation educational programme will include: brief anti-smoking counseling, mMRC scale, checklist, training patient on correct use of inhaling. Participating physicians will receive training in brief anti-smoking counselling and will be asked to record information about. Additional form containing the mMRC dyspnoea scale will be inserted into patients' medical records. We will elaborate a checklist for practitioners with information about what should be done while consulting a patient with COPD. Investigators will provide practices with training inhaler and train staff. Practitioners will be asked to teach patients in correct use of each device. Practitioners will be asked to put this information to the patient's medical records.
16135489|NCT01893463|Device|iTClamp50|
16135490|NCT01893450|Drug|Methimazole|
16135491|NCT01893450|Drug|Bromocriptine|
16135492|NCT01893450|Drug|Pentoxifylline|
16135493|NCT01893437|Drug|RO6799477|Single doses of RO6799477
16135494|NCT01893424|Drug|Sativex buccal spray|buccal spray
16135495|NCT01893424|Drug|CBD-THC-Piperine-PNL capsule|a capsule containing Cannabidiol and Tetrahydrocannabinol combination
16135496|NCT01893411|Drug|IncobotulinumtoxinA (16 Units per kg body weight)|Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl); Total volume 8.0 mL; 400 units; Mode of administration: intramuscular injection into spastic muscles.
16135497|NCT01893411|Drug|IncobotulinumtoxinA (12 Units per kg body weight)|Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl); Total volume 8.0 mL; 300 units; Mode of administration: intramuscular injection into spastic muscles.
16135498|NCT01893411|Drug|IncobotulinumtoxinA (4 Units per kg body weight)|Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl); Total volume 8.0 mL; 100 units; Mode of administration: intramuscular injection into spastic muscles.
16135499|NCT01893398|Other|Multidimensional stimulation group therapy|The MST program involved three levels of treatment. The first level was focused on PWA, the second level involved the caregiver, while the third one the dyad PWA-caregiver.
16135500|NCT01893385|Drug|Vitamin D (drug)|
16135501|NCT01893372|Drug|Eltrombopag|200 mg by mouth daily in a 28 day cycle.
16135502|NCT01893372|Drug|Hypomethylating Agent (HMA)|The choice of HMA agent (e.g. azacitidine or decitabine) will be the HMA the patient has received prior to enrollment on study.
16135503|NCT01893359|Drug|riboflavin ophthalmic solution, 0% dextran|
16135504|NCT01893359|Device|UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)|
16135505|NCT01893359|Device|UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)|
16135506|NCT01893359|Procedure|Laser-assisted in situ keratomileusis|
16135507|NCT01893346|Drug|CAZ-AVI|Single IV dose of Ceftazidime and Avibactam. Dosage regimen will vary depending on cohort.
16135508|NCT01893333|Procedure|Nerve sparing radical hysterectomy|"Nerve sparing radical hysterectomy
~sparing hypogastric nerve
~sparing pelvic splanchnic nerve ad pelvic plexus in cardinal ligament
~sparing distal part of hypogastric nerve and vesical branch of pelvic splanchnic nerve"
16135509|NCT01893320|Drug|Vosaroxin|"Phase I Starting Dose: 90 mg/m2 by vein on Days 1 and 4 of each cycle.
~Phase II Starting Dose: 70 mg/m2 by vein on Days 1 and 4 of each cycle, or maximum tolerated dose from Phase I."
16135510|NCT01893320|Drug|Decitabine|Phase I and II: 20 mg/m2 by vein daily for 5 consecutive days (Days 1 to 5).
16135511|NCT01893307|Radiation|Intensity-Modulated X-Ray Therapy (IMRT)|"Radiation therapy dosage 70 Gy (RBE) delivered 1 time each day, 5 days a week (Monday through Friday) for up to 33 treatments (about 6 ½ weeks).
~Treating physician evaluate each patient for possible chemotherapy."
16135512|NCT01893307|Radiation|Intensity-Modulated Proton Beam Therapy (IMPT)|"Radiation therapy dosage 70 Gy (RBE) delivered 1 time each day, 5 days a week (Monday through Friday) for up to 33 treatments (about 6 ½ weeks).
~Treating physician evaluate each patient for possible chemotherapy."
16135513|NCT01893307|Procedure|Modified barium swallow (MBS)|Modified barium swallow (MBS) performed at baseline, end of treatment visit, and at 6, 12, and 24 months after radiation therapy.
16135514|NCT01893307|Behavioral|Questionnaires|Questionnaires completed at baseline, each week while receiving radiation therapy, at end of treatment visit, at 10 - 12 weeks after radiation, and at 6, 12, and 24 months after radiation therapy.
16135515|NCT01893294|Drug|gemcitabine hydrochloride|Given IT
16135516|NCT01893294|Drug|fluorouracil|Given IV
16135517|NCT01893294|Radiation|radiation therapy|Undergo radiation therapy
16135518|NCT01893294|Other|laboratory biomarker analysis|Correlative studies
16135519|NCT01893281|Drug|Topical Testosterone Solution|Administered topically to axillae.
16135520|NCT01893242|Drug|Aleglitazar|Aleglitazar 150 mcg oral doses, once a day for approximately 3 years
16135521|NCT01893242|Drug|Placebo|Matching placebo to aleglitazar, once a day for approximately 3 years
16135522|NCT01893229|Drug|Lithium|Lithium is used as a mood stabiliser
16135523|NCT01893229|Drug|Valproate|Valproate is used as a mood stabiliser
16135524|NCT01893229|Drug|Oxcarbazepine|Oxcarbazepine is used as a mood stabiliser
16135525|NCT01893229|Drug|Quetiapine|Quetiapine is used as a mood stabiliser
16135526|NCT01893229|Drug|Olanzapine|Olanzapine is used as a mood stabiliser.
16135527|NCT01893229|Drug|Ziprasidone|Ziprasidone is used as a mood stabiliser
16135528|NCT01893203|Drug|BF-200 ALA cream|The symmetrical treatment areas will be randomized for treatments. First the treatment area will be wiped ethanol. Then sun protection factor (SPF) 20 cream will be applied on all sun-exposed areas of the skin. Then a 0,25mm layer application of Ameluz cream on the area. After appropriate absorption time of 30 minutes, the patients will be taken to the hospital balcony for 2 hour illumination with daylight to accomplish the phototoxic reaction. Maximum dosage will be 2 grams. The treatment will be repeated after 2 weeks for thicker gr II-III lesions with the same protocol.
16135529|NCT01893203|Drug|MAL cream|The symmetrical treatment areas will be randomized for treatments. First the treatment area will be wiped ethanol. Then SPF20 sun protection cream will be applied on all sun-exposed areas of the skin. Then a 0,25mm layer application of Metvix cream on the area. After appropriate absorption time of 30 minutes, the patientswill be taken to the hospital balcony for 2 hour illumination with daylight to accomplish the phototoxic reaction. Maximum dosage will be 2 grams. The treatment will be repeated after 2 weeks for thicker gr II-III lesions with the same protocol.
16135530|NCT01893190|Drug|Nimodipine|Based upon Investigator Judgement
16135531|NCT01893190|Drug|Nimodipine Microparticles|Based upon Investigator Judgement
16135532|NCT01893177|Biological|Inflexal V|Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL Inflexal V
16135533|NCT01893164|Procedure|simple decompression|decompression of the ulnar nerve
16135534|NCT01893164|Procedure|anterior subcutaneous transposition|transposition of the ulnar nerve into subcutaneous bed
16135535|NCT01893164|Procedure|anterior intramuscular transposition|transposition of the ulnar nerve into muscular tissue
16135536|NCT01893151|Drug|Iguratimod|Iguratimod placebo:25 mg/tablet, taken orally, 2 tablets/day (bid),52week
16135537|NCT01893151|Drug|Iguratimod placebo|Iguratimod placebo:25 mg/tablet, taken orally, 2 tablets/day (bid),24week; Iguratimod:25 mg/tablet, taken orally, 2 tablets/day (bid),28week.
16135538|NCT01893138|Biological|Roll-in: AMDC for USR|AMDC for USR is the study product (autologous muscle derived cells for urinary sphincter repair).
16135539|NCT01893138|Other|Placebo|Placebo control is the vehicle solution used for the study product.
16135540|NCT01893138|Biological|AMDC for USR|AMDC for USR is the study product (autologous muscle derived cells for urinary sphincter repair).
16135541|NCT01893138|Other|Roll in: Placebo|Placebo control is the vehicle solution used for the study product.
16135542|NCT01893125|Drug|CNV2197944|
16135543|NCT01893125|Drug|Placebo|
16135544|NCT01893112|Behavioral|Unity Workshop|The intervention is based on other stigma reduction programs that are being used internationally (HIV Stigma Toolkit developed by the International Center for Research on Women and trigger videos developed by International Training & Education Center for health).
16135545|NCT01893112|Behavioral|Breast Cancer Screening|
16135546|NCT01893099|Drug|Sorafenib|Sorafenib will be given at the dosage of 400 mg BID. Initiation of the drug will vary dependently of the cohort and will be continued until progressive disease or intolerance.
16135547|NCT01893099|Device|Radioembolization with SIR-Spheres® (Yttrium Microspheres)|
16135548|NCT01893086|Procedure|LH alone|LH, laparoscopic hysterectomy
16135549|NCT01893086|Procedure|LH with opportunistic salpingectomy|LH, laparoscopic hysterectomy
16135550|NCT01893073|Behavioral|Mindful walking program|
16135551|NCT01893060|Drug|Povidone-Iodine|Povidone-Iodine, USP, Swabstick Singles, applied twice a day to cord stump while umbilical line(s) are in place
16135810|NCT01890902|Drug|Ketoprofen 10% Cream|
16135552|NCT01893060|Drug|Chlorhexidine gluconate|Chlorhexidine Gluconate 2% w/v; 70% Isopropyl Alcohol v/v Swabstick Single, applied twice a day to cord stump while umbilical line(s) are in place
16135553|NCT01893060|Drug|Pluronic Cream|Pluronic cream - (F68, Polymyxin, Nystatin, Nitrofurantoin )applied twice a day to cord stump while umbilical line(s) are in place
16135554|NCT01893060|Other|control|No product is applied to cord stump while umbilical line(s) are in place. This is the current standard of care at UVA.
16135555|NCT01893047|Behavioral|live music|live harp music
16135556|NCT01893047|Behavioral|recorded music|recorded harp music
16135557|NCT01893034|Procedure|Arthroscopic treatment of femoroacetabular impingement|
16135558|NCT01893034|Other|Physiotherapy and activity modification|
16135559|NCT01893008|Other|Inspiratory Muscle Training (IMT)|"The IMT protocol is tailored individually. Inspiratory load is set at 60% of the measured maximal inspiratory pressure (Pimax). The load is incrementally increased based on the rate of perceived exertion (RPE) scored on a scale from 0 to 10 which is scored by the patient after each training session. When patients score an RPE below 7, patients increase the inspiratory load of the threshold device with 5% to guarantee overload during each training session. Patients have to complete 30 dynamic inspiratory efforts twice daily.
~Patients will be instructed to train at home 7 days a week until surgery with a minimum of 2 weeks.
~Training will be started after the chemoradiation period (if applicable)."
16135560|NCT01892995|Drug|Ketamine|
16135561|NCT01892982|Behavioral|Problem Solving Education tailored to NICU|
16135562|NCT01892956|Other|Nutritional intervention|"2 dietary interventions
~personalized diet based on algorithm predictions of glucose response to foods
~Mediterranean-style diet"
16135563|NCT01892930|Radiation|stereotactic body radiation therapy|Undergo SBRT
16135564|NCT01892930|Procedure|therapeutic conventional surgery|Undergo partial or radical nephrectomy
16135565|NCT01892930|Other|laboratory biomarker analysis|Correlative studies
16135566|NCT01892904|Drug|EE20/DRSP(BAY86-5300)|One tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day
16135567|NCT01892891|Drug|VBY-036|Cathepsin S inhibitor
16135568|NCT01892878|Procedure|VerteLoc|Single Arm
16135569|NCT01892865|Other|Scheduling using historical means|Scheduling will be performed taking into account historical means only for anesthetic, operative, and turn around time
16135570|NCT01892865|Other|Scheduling using regression modeling system|A regression model that uses predictor of operative length will be used to predict operative, anesthetic, and turn around time length
16135571|NCT01892852|Procedure|Acupuncture|Acupuncture treatment will be performed by licensed doctors in Traditional Korean Medicine using 0.20 mm (diameter) X 0.40 mm (length) sized disposable acupuncture 3 times per week for 3 weeks. Acupuncture points are GV20, GB20 (bilateral), LI11 (bilateral), LI10 (bilateral), EX-UE9 (bilateral), ST36 (bilateral), ST40 (bilateral), and EX-LE10 (bilateral). Each session lasts 20-30 minutes.
16135572|NCT01892839|Other|low dialysate flow, smaller dialyzer|The subject will receive dialysis on the usual schedule and for the usual time but with a lower than usual dialysate flow and small dialyzer.
16135573|NCT01892839|Other|high dialysate flow, larger dialyzer|The subject will receive dialysis on the usual schedule and for the usual time but with a higher than usual dialysate flow and large dialyzer.
16135574|NCT01892826|Drug|hCG|5000IU
16135575|NCT01892813|Drug|Nicotine replacement therapy - Transdermal nicotine patch|Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
16135576|NCT01892813|Drug|Nicotine replacement therapy - Nicotine gum|Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
16135577|NCT01892813|Drug|Nicotine replacement therapy - Nicotine lozenge|Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
16135578|NCT01892813|Drug|Bupropion|Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
16135579|NCT01892813|Drug|Varenicline|Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
16135580|NCT01892813|Drug|Combination pharmacotherapy - Transdermal nicotine patch + nicotine gum|Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
16135581|NCT01892813|Drug|Combination pharmacotherapy - Transdermal nicotine patch + nicotine lozenge|Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
16135582|NCT01892813|Drug|Combination pharmacotherapy - Transdermal nicotine patch + bupropion|Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
16135583|NCT01892813|Behavioral|Tobacco quitline referral|Participants assigned to this condition will receive a referral to their state tobacco quitline. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence.
16135584|NCT01892813|Behavioral|Tailored behavioral intervention|Participants will receive a standard six session cognitive behavioral intervention for smoking cessation combined with supplemental treatment modules based on individual need and preference.
16135585|NCT01892813|Behavioral|Alcohol use risk reduction|Participants engaging in risky alcohol use may receive this six-session telephone-based behavioral intervention for reducing alcohol use.
16135586|NCT01892813|Behavioral|Behavioral activation for depressive symptoms|Participants with elevated depressive symptoms may receive this six-session telephone-based behavioral activation intervention.
16135587|NCT01892813|Behavioral|Behavioral management of postcessation weight gain|Participants with concerns about gaining weight after quitting smoking may receive this six-session telephone-based behavioral self-management intervention designed to help attenuate post-cessation weight gain.
16135588|NCT01892800|Procedure|Lung resection|
16135589|NCT01892787|Drug|Formoterol|Participants receive Atimos for 1 to 2 weeks.Partcipants then enter a washout period and after the washout period receive the alternative treatment arm.
16135590|NCT01892787|Drug|Salmeterol|Participants receive Serevent for 1 to 2 weeks. Participants then enter a washout period and after the washout period receive the alternative treatment arm.
16135811|NCT01890902|Drug|Placebo|
16135812|NCT01890889|Dietary Supplement|Ad-Chol-Pre|
16135591|NCT01892774|Procedure|Radiofrequency catheter ablation|Extended PVAI plus ablation of non-pulmonary vein (non-PV) triggers and complex fractionated electrograms (CAFÉ)
16135592|NCT01892761|Drug|Renal transplant recipients were allocated to TCL/MMF or to CyA/MMF groups|
16135593|NCT01892748|Drug|Cholecalciferol|All patients and physicians were blinded to group assignment and treatment allocation. The first group received oral cholecalciferol of 50,000 IU/week and for 6 months. All subjects were evaluated at baseline and after the end of supplementation for clinical and laboratory parameters.
16135594|NCT01892748|Drug|Placebo|The second group received identical placebo tablets for 6 months. All subjects were evaluated at baseline and after the end of supplementation for clinical and laboratory parameters.
16135595|NCT01892722|Drug|Interferon beta-1a|Administration once weekly via i.m. injections.
16135596|NCT01892722|Drug|Fingolimod|"Administrated orally once daily:
~0.5 mg capsule for patients over 40 kg or 0.25 mg capsule for patients 40 kg or less."
16135597|NCT01892722|Drug|Placebo capsule|Matching placebo capsule required for double-dummy masking to blind formulations.
16135598|NCT01892722|Drug|Placebo i.m. injection|Matching placebo i.m. injection required for double-dummy masking to blind formulations.
16135599|NCT01892709|Drug|Hydromorphone|
16135600|NCT01892696|Device|varying inspiratory flow waveforms|inspiratory flow waveform was changed, in a randomized sequence using a computer ,to one of the following modalities: 1) constant inspiratory flow; 2) decelerating inspiratory flow Each inspiratory flow waveform was maintained for 30 min. During the last 5 min of this period the physiological signals were collected and measures were performed.
16135601|NCT01892683|Drug|General anesthesia with propofol|Study subjects will undergo general anesthesia with propofol according to the clinical standard protocol practiced at the hospital of the University of Munich.
16135602|NCT01892670|Other|Donation of 1 whole blood unit|Donation of 450-500 mL of whole blood according to local blood bank procedures and national guidelines.
16135603|NCT01892657|Drug|Facial Moisturizer with SPF 50+|All subjects received applications of occlusive patches dosed with Cetaphil Daily Facial Moisturizer with SPF 50+
16135604|NCT01892644|Drug|Deferasirox|Deferasirox tablets ( 250 mg or 500 mg) dispersed in a drinkable solution, 10 mg/kg/day, once daily for 12 months
16135605|NCT01892644|Other|Venesection|Treated with venesection every 8-10 day for 12 months, or until serum-ferritin has been reduced to about 50 µg/L.
16135606|NCT01892644|Drug|Deferasirox|Deferasirox tablets ( 250 mg or 500 mg) dispersed in a drinkable solution starting with 10 mg/kg/day, once daily for 2 weeks and thereafter 20 mg/kg/day for 11,5 months.
16135607|NCT01892631|Other|Text message influenza vaccination reminder|Practices in the text messaging intervention arm will be asked to send a text message to patients under 65 at risk of influenza.
16135608|NCT01892631|Other|Standard care|Practices in the standard care arm will be asked to proceed with their seasonal influenza campaign as planned.
16135609|NCT01892618|Drug|Prevenar 13|13-valent pneumococcal conjugated vaccine
16135610|NCT01892618|Drug|Pneumovax|23-valent pneumococcal polysaccharide vaccine
16135611|NCT01892605|Behavioral|music listening|The treatment group listened to Mozart K.448 for eight minutes once daily before bedtime for at least six months.
16135612|NCT01892592|Behavioral|Diet and Lifestyle|Patients will receive up to 16 phone based coaching sessions
16135613|NCT01892579|Behavioral|Tailored Activity Program|TAP is designed to tap into spared or residual abilities and provide an environment supportive of these abilities. Activities are selected that build on preserved capabilities, long-term interests and procedural memory, but which do not tax areas of cognition that are most impaired (e.g., memory, new learning). Activities selected are simplified (1 to 2 vs multiple, complex steps), thereby minimizing errors. The activity environment is set up to provide auditory or tactile cues to facilitate recall and guide initiation and sequencing. By grading activities to match PwD capabilities, the interventionist minimizes demand that may heighten stress (e.g., high functioning individuals are introduced to more goal-directed, multi-step activities, whereas lower functioning individuals are introduced to activities involving repetitive motion (e.g., washing windows, folding towels, placing materials in a bin) and integrate multi-sensory stimulation (e.g., soft music, objects pleasant to touch).
16135614|NCT01892579|Other|Home Safety and Education Program|The control group intervention is designed to control for the nonspecific elements of TAP such as social engagement with PwD and CG which may affect outcomes. It is a fully-structured, nondirective, supportive education approach that conveys empathy, respect and specific disease education elements of which have been tested in other trials. Unlike TAP, this group contains no active elements beyond its nonspecific components, has no long-lasting treatment effects, and no theoretical basis to support an effect on agitation. It is delivered by a trained research team member who uses active listening, open questioning, reflecting back, and summation with CGs.
16135615|NCT01892566|Other|mHealth Intervention|See arm description
16135616|NCT01892553|Device|tDCS|"Procedure : 3 different sessions of tDCS (listed below) presented in random order, each applied at a different study visit
~Anodal tDCS: Intensity of 1.25 milliAmperes (mA) during 15 min
~Cathodal tDCS: Intensity of 1.25 mA during 15 min
~Sham tDCS (placebo) (1.25 mA maintained only during the first 30 sec of the 15 minutes application)"
16135617|NCT01892540|Diagnostic Test|positron emission tomography/computed tomography|Undergo PET/CT
16135618|NCT01892540|Diagnostic Test|PET/MRI|Undergo PET/MRI positron emission tomography/magnetic resonance imaging hybrid imaging
16135619|NCT01892540|Device|Position Device|
16135620|NCT01892527|Drug|Tivantinib (ARQ197)|Eligible subjects will be treated with tivantinib (ARQ 197) at a dose of 360 mg twice daily (a total daily dose of 720 mg) orally in a continuous manner and cetuximab (Erbitux) at a dose of 500 mg/mq i.v. every 2 weeks.
16135621|NCT01892514|Procedure|core decompression|core decompression of necrotic area and graft with Platelet-Rich Fibrin (PRF) and Concentrated Bone Marrow (CBM)
16135622|NCT01892501|Procedure|Guided punction of mediastinal lymphadenopathy by echoendoscopy|"EUS (by oesophageal) is performed within a maximum period of six weeks after the PET scan, under general anesthesia and endoscopic control, with a disposable 19-gauge needle (EchoTip, Cook Endoscopy) and 3 passes of the needle ganglion.
~Pathological samples are taken :
~3 tubes collected by node (one tube per needle pass), in most cases, only one node will be taken."
16135623|NCT01892501|Device|PET scan|The benefits of combined PET and punction EUS for the diagnosis and subsequent therapeutic management should be evaluated in these different contexts
16135624|NCT01892488|Drug|Sultamicillin|"Standard of care: Each patient will receive inhaled fast-acting bronchodilators (up to a maximum of 4 - 6 times daily 2 puffs (100µg) of salbutamol or other equivalent inhaled fast-acting bronchodilators), systemic corticosteroids (prednisolone 40mg/d p.o. for 7 - 10 days) and oxygen in case of hypoxemia in a standardized fashion. The pre-existing COPD medication will be continued as indicated.
~Experimental intervention:
~Antibiotic therapy with aminopenicillin + betalactamase inhibitor (oral Sultamicillin (2 x 750mg)) for 5 days as supplement to standard of care for patients with AE-COPD."
16135625|NCT01892488|Drug|Placebo|"Standard of care: Each patient will receive inhaled fast-acting bronchodilators (up to a maximum of 4 - 6 times daily 2 puffs (100µg) of salbutamol or other equivalent inhaled fast-acting bronchodilators), systemic corticosteroids (prednisolone 40mg/d p.o. for 7 - 10 days) and oxygen in case of hypoxemia in a standardized fashion. The pre-existing COPD medication will be continued as indicated.
~Control intervention:
~Placebo for 5 days as supplement to standard of care for patients with AE-COPD"
16135626|NCT01892475|Behavioral|Incentive-based physical activity program|"Drivers will be offered rewards valued at a day's rental for meeting daily step targets over the specified number of days each month from Months 1 to 4, where steps will be tracked by a step counter. They will also be offered incentives for meeting the following criteria:
~Accurately predicting step target attainment the following months (SGD10)
~Wearing and providing step data over the month (SGD10 and a chance to win 1 of 3 cash prizes valued at SGD500)"
16135627|NCT01892475|Behavioral|3-month follow up|After the 4-month RCT, drivers will be incentivized to wear the step counter for another 3 months (i.e. Months 5 to 7) to test if effects of the rewards are sustained once the reward is no longer in place. For wearing their step counter and providing their step data, drivers will receive a modest cash incentive (amounting to SGD10) each month as well as the chance to win 1 of 3 cash prizes valued at SGD500.
16135628|NCT01892449|Other|prolonged inspiratory to expiratory (I:E) ratio (1:1)|80 patients are randomly allocated into two groups : prolonged I:E ratio (1:1) (n=40) and conventional I:E ratio (1:2) group (n=40). In the prolonged I:E ratio (1:1), mechanical ventilation is maintained with during I:E ratio 1:1 during steep trendelenburg with pneumoperitoneum.
16135629|NCT01892449|Other|conventional I:E ratio (1:2)|80 patients are randomly allocated into two groups : prolonged I:E ratio (1:1) (n=40) and conventional I:E ratio (1:2) group (n=40). In the conventional I:E ratio (1:2) group (n=40), mechanical ventilation is maintained with during I:E ratio 1:2 during steep trendelenburg with pneumoperitoneum.
16135630|NCT01892436|Drug|Secukinumab|"Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a messenger protein in the body) called Interleukin 17 (IL-17)."
16135631|NCT01892436|Drug|Placebo|Placebo
16135632|NCT01892423|Other|Cetaphil Moisturizing Lotion Daily Advance|
16135633|NCT01892410|Other|Cetaphil Restoraderm Skin Restoring Body Wash|Diluted (10%) 0.2ml or 0.2g of Cetaphil on semi-occlusive, hypoallergenic patch applied to skin for 24 hrs 9 times on Monday, Wednesday, and Friday for 3 weeks
16135634|NCT01892397|Device|Optune (NovoTTF-100A)|
16135635|NCT01892384|Drug|Placebo|matching placebo
16135636|NCT01892384|Drug|BI 409306|low dose
16135637|NCT01892384|Drug|BI 409306|medium dose
16135638|NCT01892384|Drug|BI 409306|high dose
16135639|NCT01892371|Drug|Azacitidine|Given SC or IV
16135640|NCT01892371|Drug|Cytarabine|Given SC
16135641|NCT01892371|Other|Pharmacodynamic Study|Correlative studies
16135642|NCT01892371|Drug|Quizartinib|Given PO
16135643|NCT01892358|Behavioral|SKIN Intervention|
16135644|NCT01892358|Other|Treatment as Usual|
16135645|NCT01892345|Drug|Eculizumab|Induction Phase: 900 mg IV weekly for 4 weeks, followed by 1200 mg for the fifth dose; Maintenance Phase: 1200 mg IV every 2 weeks
16135646|NCT01892345|Drug|Placebo|Induction Phase: matching placebo (900 mg) IV weekly for 4 weeks, followed by matching placebo (1200 mg) for the fifth dose; Maintenance Phase: matching placebo (1200 mg) IV every 2 weeks
16135647|NCT01892332|Drug|epidural block with lidocaine and fentanyl|"The study method was a step-up/step-down sequence model where the dose for following patients was determined by the outcome of the preceding block. The starting concentration of lidocaine was 1.5 % mixed with fentanyl 75 ug. All patients receive 13mL of lidocaine with fentanyl 75ug. The concentration of lidocaine for subsequent patients is determined by the outcome in the previous patient according to up and down sequential allocation in 0.1% increments. In the case of block failure, the concentration of lidocaine was increased by 0.1%.
~Conversely, block success resulted in a reduction in concentration by 0.1%."
16135648|NCT01892319|Drug|insulin detemir|Patients will be treated according to routine clinical practice at the discretion of the treating physician
16135649|NCT01892319|Drug|other injectable antidiabetic treatment regimens|Patients will be treated according to routine clinical practice at the discretion of the treating physician
16135650|NCT01892306|Behavioral|UP CBT|The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders
16135651|NCT01892306|Drug|Treatment as usual|Existing optimized pharmacotherapy as delivered by treating psychiatrist
16135652|NCT01892293|Drug|Treatment with NY-ESO-1c259-modified T cells|"An intended total dose of ≥0.1-1e10 total cells will be administered as a single infusion. A low dose infusion of 1e8 to < 1e9 will be allowed for patients if cells do not expand sufficiently to reach the target dose range.
~For patients whose disease progresses and whose tumor still expresses tumor antigen and HLA-A201, a second infusion of up to 5e10 cells may be given."
16135653|NCT01892280|Behavioral|Teenwork intervention|Set of psychoeducational modules focused on optimizing diabetes self-care through blood glucose monitoring and insulin administration
16135654|NCT01892280|Behavioral|Text message reminders|Text message reminders to check blood glucose levels at self-selected times
16135655|NCT01892267|Device|PEG-J placement|PEG-J placement
16135656|NCT01892254|Drug|Metformin|Metformin, 2x 2 tablets a day, 500 mg tablets
16135657|NCT01892254|Drug|Placebo|Placebo (to metformin)
16135658|NCT01892241|Drug|Pegasys(Roche)|180µg of peginterferon alfa-2a (Pegasys,Roche) once weekly for 48 weeks.
16135659|NCT01892241|Drug|Entecavir|continual entecavir therapy(0.5 mg orally once daily)
16135660|NCT01892228|Behavioral|Immediate post-screening treatment education|immediate treatment education after screening to decrease time from initial HIV screening to treatment implementation
16135661|NCT01892215|Procedure|Cephalad-caudad expansion|Blunt expansion of the uterine incision by the physician separating the fingers in a cephalad-caudad direction.
16135662|NCT01892215|Procedure|Transversal expansion|Blunt expansion of the uterine incision by the physician separating the fingers in a transversal direction.
16135663|NCT01892202|Other|Cohort|
16135664|NCT01892189|Drug|Ketamine|Ketamine intravenous administration.
16135665|NCT01892189|Drug|TAK-063|TAK-063 tablets
16135666|NCT01892189|Drug|TAK-063 Placebo|TAK-063 placebo-matching tablets
16135667|NCT01892176|Dietary Supplement|coenzyme q10|400mg/day, 800mg/day, 1200/day and 2400mg/day
16135668|NCT01892163|Device|Ozurdex|Dexamethasone implant (Ozurdex)
16135669|NCT01892150|Other|Sunscreen|Apply sunscreen before and after UVA and UVB irradiation
16135670|NCT01892137|Drug|Ingenol mebutate gel 0.05%|Once daily for 2 consecutive days
16135671|NCT01892124|Behavioral|Motivational Interviewing/Cognitive Behavioral-based Therapy|
16135672|NCT01892111|Other|Structured exercise program.|
16135673|NCT01892098|Dietary Supplement|Zinc Sulfate|9mg elemental zinc via 23mg zinc sulfate/day
16135674|NCT01892098|Dietary Supplement|Placebo|Cellulose pill given as placebo
16135675|NCT01892085|Behavioral|Early initiation|Initiation of breast milk expression <1 hour following delivery.
16135676|NCT01892085|Behavioral|Intermediate expression|Initiation of milk expression 1-<3 hours following delivery.
16135677|NCT01892085|Behavioral|Late initiation|Initiation of milk expression >3-6 hours following delivery.
16135678|NCT01892072|Procedure|surgical treatment|all the patients in the study must have been treated by the surgery at the first time and have been confirmed as 'complete section' by the post-surgery radiological image.
16135679|NCT01892059|Procedure|Segmental artery clamping|Laparoscopic partial nephrectomy with segmental artery clamping will be performed for patients enrolled in this group.
16135680|NCT01892059|Procedure|Main renal artery clamping|Laparoscopic partial nephrectomy with main renal artery clamping technique will be performed for patients enrolled in this group.
16135681|NCT01892046|Drug|SNX-5422|Capsule dosed every other day for 21 days out of a 28 day cycle. Dose escalation based on safety. Maintenance doses at the maximum tolerated dose.
16135682|NCT01892033|Behavioral|Aerobic Exercise|12 weeks of brisk walking
16135683|NCT01892020|Drug|biphasic insulin aspart 50|Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin.
16135684|NCT01892020|Drug|biphasic human insulin 50|Administered subcutaneously (s.c., under the skin) twice daily (BID). Dose individually adjusted. All subjects will receive metformin in combination with trial insulin.
16135685|NCT01892007|Behavioral|Cogmed RM - Online adaptive working memory training|
16135686|NCT01892007|Behavioral|Cogmed RM - Online non-adaptive (placebo) working memory training|
16135687|NCT01891994|Drug|Eltrombopag|Oral administration of eltrombopag 150mg/day (75 mg/day for East Asian ancestry) for 6 months
16135688|NCT01891981|Drug|Moxetumomab Pasudotox|"Phase I Starting Dose: 30 µg/kg by vein every other day for 6 doses on Days 1, 3, 5, 7, 9, and 11 of each 21-day cycle.
~Phase II Starting Dose: Maximum tolerated dose from Phase I."
16135689|NCT01891968|Drug|Bortezomib|1.3 mg/m2 subcutaneously on days 1, 4, 8 and 11 of a 21 day cycle.
16135690|NCT01891955|Behavioral|Healthy diet A|"Healthy diet A will include fruit, vegetables, fish, shellfish, lean meat, nuts, eggs and olive oil. Macro/micronutrient composition, fiber intake and glycemic load will not differ from healthy diet B. Healthy diet A will include substantial amounts of whole grains, low-fat dairy and legumes (this is called healthy diet with grains and dairy). This diet is classified as very healthy using validated nutritional software. It is in accordance with official Spanish dietary recommendations for people with diabetes type 2 regarding macronutrient composition, dietary fiber, minerals and vitamins."
16135691|NCT01891955|Behavioral|Healthy diet B|"Healthy diet B will include fruit, vegetables, fish, shellfish, lean meat, nuts, eggs and olive oil. Macro/micronutrient composition, fiber intake and glycemic load will not differ from healthy diet A. Healthy diet B will exclude grains, legumes and dairy, which will largely be replaced by root vegetables, vegetables and fruit, and slightly more lean meat, fish and nuts (this is called healthy diet without grains and dairy). Salt intake will be lower in healthy diet B. This diet is classified as very healthy using validated nutritional software. It is in accordance with official Spanish dietary recommendations for people with diabetes type 2 regarding macronutrient composition, dietary fiber, minerals and vitamins."
16135692|NCT01891942|Procedure|twitch by magstim|
16135693|NCT01891929|Behavioral|RECOS (COgnitive REmediation for Schizophrenia)|"Every RECOS patient will benefit, with his therapist, from 2 sessions of 1 hour of training per week over a 14 weeks period (M1 to M3), plus 1 hour per week of task to be realized at home. All in all, it is thus about a training period of 42 hours.
~After remediation, the follow-up of the patient will be led by his therapist with monthly appointments during 6 months (M4 to M9).
~In parallel, neuropsychological and clinical scores will be assessed before (M0) and after the training period (M3), as well as at the end of the study (M9). Working and relational abilities will be assessed at the beginning and at the end of the working period (M4 and M9)."
16135694|NCT01891929|Behavioral|TAU (Treatment As Usual)|"The treatment of the group TAU (Treatment As Usual) will consist of the usual care proposed by every service of the various inquiring centers involved. No additional session will be proposed.
~In parallel, neuropsychological and clinical scores will be assessed before (M0) and after the training period (M3), as well as at the end of the study (M9). Working and relational abilities will be assessed at the beginning and at the end of the working period (M4 and M9)."
16135695|NCT01891916|Dietary Supplement|Extensively hydrolyzed casein formula + LGG|Extensively hydrolyzed formula containing Lactobacillus GG
16135696|NCT01891890|Drug|Oxcarbazepine|Titration to target dose starting at week 3. Dose increments above target may be made to a maximum of 3 increments with a minimum interval between dose escalations of 2 weeks.
16135697|NCT01891890|Drug|Levetiracetam|Titration to target dose starting at week 3. Dose increments above target may be made to a maximum of 3 increments with a minimum interval between dose escalations of 2 weeks.
16135698|NCT01891890|Drug|Lamotrigine|Titration to target dose starting at week 11. Dose increments above target may be made to a maximum of 3 increments with a minimum interval between dose escalations of 2 weeks.
16135699|NCT01891864|Drug|GP2015 Etanercept|Sandoz has developed GP2015 Etanercept (Sandoz's code for the drug product containing the active ingredient etanercept) to be biosimilar to Enbrel.
16135700|NCT01891864|Drug|Enbrel|Enbrel is used as reference product to GP2015.
16135701|NCT01891851|Drug|TMC435350 200 mg|Each patient will receive 200 mg (2 capsules) once daily orally from Day 1 to Day 7 in Session 1 and from Day 6 to Day 12 in Session 2
16135702|NCT01891851|Drug|Ritonavir 100 mg|Each patient will receive 100 mg (1 capsule) of ritonavir twice daily orally from Day 1 until Day 15 of Session 2
16135703|NCT01891838|Procedure|Volume controlled ventilation|
16135704|NCT01891838|Procedure|Pressure-controlled ventilation|
16135705|NCT01891825|Procedure|Surgical AF ablation|Minimally invasive thoracoscopic surgical ablation of atrial fibrillation
16135706|NCT01891825|Procedure|Percutaneous AF ablation|Percutaneous catheter ablation of atrial fibrillation
16135707|NCT01891812|Drug|Nitrous oxide 50%|
16135708|NCT01891799|Other|Option B+|"Using one low toxicity triple ARV regimen [(tenofovir (TDF) + lamivudine/emtricitabine (3TC/FTC) + efavirenz (EFV)] for all women, rather than adapting regimens by CD4+
~Engaging all pregnant and postpartum women and their infants in the structured appointment and follow-up system currently only available to women receiving ART
~Providing a simplified standardized public health approach both antenatally and postnatally, with adherence and retention support tailored to the particular health and social needs of peripartum women"
16135709|NCT01891786|Behavioral|Self-Management Intervention|The SMI will incorporate a discussion to introduce self-management and why it is important, and about problems associated with reducing CHD risk and managing type 2 diabetes. Specific topics addressed will include health behaviours to reduce CHD risk and manage diabetes including diet and exercise, as well as behaviours specific to managing diabetes, including medication adherence and self-care behaviours (e.g. footcare). Sessions are patient-directed and employ a shared decision-making approach, such that participants work with one another and the practice nurse facilitator to identify specific problems that they wish to address, and to identify solutions and approaches to managing their diabetes and CHD risk
16135710|NCT01891786|Behavioral|Risk Result|Participants will receive in-person personalised feedback about their combined genetic and lifestyle 10 year risk for developing CHD.
16135711|NCT01891773|Behavioral|Inhaled steroids in school.|Morning dose of inhaled steroids given in school by school nurse instead of at home.
16135712|NCT01891760|Device|Dermagraft|Dermagraft treatment regimen of one application applied topically to the ulcer, weekly, for a maximum of 8 weeks (8 application maximum).
16135713|NCT01891760|Device|Profore|Four-layer compression bandaging therapy.
16135714|NCT01891747|Drug|Bevacizumab|bevacizumab at 10mg/kg IV every 14 days (Phase I & phase II)
16135715|NCT01891747|Drug|Temozolomide|150 mg/m2/day for a 5-day regimen per month (Phase I & Phase II)
16135716|NCT01891747|Dietary Supplement|Vitamin C|250 mg vitamin C once a day (oral) - Phase I & Phase II
16135717|NCT01891734|Other|Problem Solving Therapy plus Moving Forward|All Veterans will receive a standard 6-session administration of Problem Solving Therapy (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes. Participants in this arm will also receive the Moving Forward app for SmartPhones, which was adapted from Problem Solving Therapy to be used either as a standalone treatment or as an adjunct to other related therapies such as in-person Problem Solving Therapy or the Moving Forward website. The phone content matches Problem Solving Therapy. Benefits of the app include 24-hours accessibility of psychoeducational materials and worksheets.
16135718|NCT01891734|Other|Problem Solving Therapy|All Veterans will receive a standard 6-session administration of Problem Solving Therapy (Nezu & D'Zurilla, 1999). Session 1 will take place in-person during a scheduled appointment and will last for 1 hour. Subsequent sessions will take place over the telephone and will last for approximately 30 minutes.
16135719|NCT01891721|Behavioral|Brain Fitness Program (BFP)|"This computerized bottom-up cognitive intervention is designed to improve the speed and accuracy of auditory information processing through increasingly more difficult stimulus recognition, discrimination, sequencing, and memory tasks under conditions of close attentional control, high reward, and novelty. BFP consists of 6 exercises. Stimuli across the exercises are chosen such that they span the acoustic and organizational structure of speech, from very simple acoustic stimuli and tasks to complex manipulations of continuous speech. The exercises adaptively progress based on the subject's individual performance during a training session and become more challenging as the subject's abilities improve. Participants will work with 4 of the 6 exercises (15 min per exercise) in each session."
16135720|NCT01891721|Behavioral|Cognitive Package (Cogpack)|"This computerized top-down cognitive intervention is designed to provide training across a broad range of cognitive functions. Cogpack consists of domain-specific exercises aimed at training specific cognitive areas (attention, working memory, verbal and visual memory, executive functioning, reasoning, language) and non-domain-specific exercises that require the use of several functions at a time. Cogpack includes low-level cognitive exercises (i.e., scanning, hand-eye coordination, and psychomotor speed) that will not be included in this protocol to better separate bottom-up from top-down training interventions. There will be a total of 34 exercises and variants of the same exercises with different levels of difficulty. In each session, participants will work on a different subset of 4 to 6 exercises."
16135721|NCT01891721|Behavioral|Commercial Computer Games (Sporcle)|"Sporcle computer games will be used as a placebo treatment to control for the effects of computer exposure, contact with research personnel, time spent being cognitively active, and financial compensation for participation. The games cover trivia-type questions about geography, entertainment, science, history, literature, sports, movies, etc. Subjects will receive the same amount of attention from staff members and the same monetary reinforcements as participants in the experimental treatment groups. They will also complete 3 hours of training per week over 12 weeks, for a total of 36 hours."
16135722|NCT01891708|Other|bevacizumab, standard chemotherapy and radiation|the dose and application model of the three intervention are not specified by the sponsor who just observe the efficacy of the combination application of the three in non small cell lung cancer patients with brain metastasis once enrolled.
16135723|NCT01891695|Radiation|39.6 Gy radiation|
16135724|NCT01891682|Other|Observational|Observational, Translational non-treatment study
16135813|NCT01890889|Dietary Supplement|Half-dose Ad-Chol-Pre|
16135725|NCT01891669|Drug|PF-06263507|Part 1 - PF-06263507 will be administered intravenously in 21-day cycles in cohorts of 2 or more patients starting at a dose of 0.05 mg/kg. Increases in dose will continue until MTD is determined.
16135726|NCT01891669|Drug|PF-06263507|Part 2 - Patients with select tumor types will be treated at the MTD or Recommended Phase 2 dose selected in Part 1.
16135727|NCT01891656|Behavioral|Motivational Interviewing|"MI is a client centered, directive style of interacting with a person to help explore and resolve ambivalence about change (Miller & Rollnick, 2002). MI borrows from Client-Centered Counseling in its emphasis on empathy, optimism, and respect for client choice (Rogers, 1961). MI also draws from Self-Perception Theory, which says that a person becomes more or less committed to an action based on the verbal stance he or she takes (Bem, 1972). The effects of MI tend to be in the small-to-medium range when compared to no treatment, and nonsignificant when compared to more extensive treatment."
16135728|NCT01891656|Behavioral|Motivational Computer|The growing use of technology has led to the development of automated interventions for behavior change, including some that target drug and alcohol use (Elliott, et al, 2008; Lustria, et al, 2009; Revere & Dunbar, 2001; Walters, et al, 2006) and treatment interest (Lieberman & Massey, 2008). As discussed by Hester & Miller (2006), automated interventions have several potential advantages over face-to-face interventions: (I) They require little or no staff contact, which may increase cost-effectiveness; (2) they can allow for automatic data collection and follow-up; and (3) they can be disseminated with little loss of fidelity.
16135729|NCT01891643|Drug|Lenalidomide|
16135730|NCT01891643|Drug|Dexamethasone|
16135731|NCT01891643|Biological|Elotuzumab|
16135732|NCT01891617|Other|Exercise and diets|Exercise and high-fat diet Exercise and high-carbohydrate diet Sedentary and high-fat diet Sedentary and high-carbohydrate diet
16135733|NCT01891604|Dietary Supplement|breast milk with Bifidobacterium Longum subp. Infantis R0033|
16135734|NCT01891604|Dietary Supplement|breast milk|
16135735|NCT01891591|Procedure|Roux-en-Y gastric bypass (RYGP)|
16135736|NCT01891565|Behavioral|Feedback|
16135737|NCT01891526|Drug|9-cis-retinoic acid|Single dose of 9-cis-retinoic acid (Capsule 30 mg) as oral exposure
16135738|NCT01891513|Behavioral|Exercise|All participants will take part in 3 days/week of structured aerobic, stretching, and balance training for weeks 1-12. For weeks, 13-24, training will be reduced to 2 days/week and a resistance training component added. Participants will also be expected to engage in 2 bouts of 30 minutes of home-based walking per week.
16135739|NCT01891513|Drug|ACE inhibitor + exercise|In addition to exercise training, participants will receive an initial perindopril dose of 2 mg/day which will be titrated to 4 mg/day.
16135740|NCT01891513|Drug|Thiazide diuretic + exercise|In addition to exercise training, participants will receive an initial hydrochlorothiazide dose of 12.5 mg/day which will be titrated to 25 mg/day.
16135741|NCT01891513|Drug|Angiotensin receptor blocker + exercise|In addition to exercise training, participants will receive an initial losartan dose of 50 mg/day which will be titrated to 100 mg/day.
16135742|NCT01891500|Drug|Inhaled nitric oxide|Drug is initiated at 20ppm. Patients randomized to receive iNO at OI 10-15.
16135743|NCT01891500|Drug|Nitrogen Gas|Placebo gas (bioinert), Patients randomized to bioinert inhaled gas at OI 10-15.
16135744|NCT01891500|Drug|Crossover iNO|Patients who deteriorate (OI >20 on two consecutive blood gases) will be unblinded. If they are receiving placebo gas, they will be started on iNO and make up the crossover cohort.
16135745|NCT01891487|Drug|Track A|Bimatoprost 0.03% solution applied to eyebrow
16135746|NCT01891487|Drug|Track B|Refresh Tears applied to eyebrows
16135747|NCT01891474|Device|U-health care|voice inception technique based U-healthcare service
16135748|NCT01891461|Drug|Floseal|Floseal (5 milliliters) will be applied to the exposed bone in the following order: around the margins of the tibia, the femur (anterior surface, intercondylar notch, exposed medial and lateral condyles) and around the un resurfaced portion of the patella. The other syringes (each of 5 milliliters) will then be applied to the supra-patellar synovium and into the medial and lateral gutters of the knee. No Floseal will be applied outside the knee joint capsule.
16135749|NCT01891448|Other|WebCONSORT tool|Authors are directed to the WebCONSORT tool. The tool allows authors to obtain a customized CONSORT checklist and flow diagram specific to their trial design (e.g., non-inferiority trial, pragmatic trial, cluster trial) and type of intervention (e.g., pharmacological or non pharmacological). The checklist items and flow diagram should then be reported in the manuscript and the completed checklist submitted to the journal along with the revision.
16135750|NCT01891448|Other|Modified WebCONSORT tool|Authors are directed to a different version of the WebCONSORT tool. This tool includes the flow diagram part of the tool but not the main checklist or elements relating to CONSORT extensions.
16135751|NCT01891435|Drug|Oral paracetamol|after giving medicine temperature is checked every 30 minutes for 2 hours
16135752|NCT01891435|Drug|Intravenous paracetamol|after giving medicine temperature is checked every 30 minutes for 2 hours
16135753|NCT01891435|Drug|Intramuscular diclofenac|after giving medicine temperature is checked every 30 minutes for 2 hours
16135754|NCT01891409|Device|Male circumcision using the Shang Ring device|
16135755|NCT01891396|Device|Hyaluronic Acid and TH|
16135756|NCT01891396|Device|Hyaluronic Acid|
16135757|NCT01891396|Device|Saline|Saline placebo packaged to look identical to comparator syringes.
16135758|NCT01891357|Procedure|Biopsy before and after three weeks of study treatment|Core biopsies for histological analyses, to be analysed by the central pathology
16135759|NCT01891357|Drug|paclitaxel|
16135760|NCT01891357|Drug|lapatinib|
16135761|NCT01891357|Drug|trastuzumab|
16135762|NCT01891344|Drug|Oral rucaparib|600 mg BID
16135763|NCT01891331|Drug|VT-1161|
16135764|NCT01891331|Drug|Fluconazole|
16135765|NCT01891318|Radiation|radiosurgery|Undergo radiosurgery
16135766|NCT01891318|Procedure|therapeutic conventional surgery|Undergo surgical resection
16135767|NCT01891318|Procedure|quality-of-life assessment|Ancillary studies
16135768|NCT01891305|Drug|VT-1161|
16135769|NCT01891305|Drug|placebo|
16135770|NCT01891292|Drug|Enalapril|0.25-0.35 mg/kg/day
16135771|NCT01891292|Drug|N-Acetylcysteine|N-Acetylcysteine 0.5 mmol/kg
16135815|NCT01890876|Other|Walking uphill|ascending about 500 m
16135772|NCT01891279|Other|elemental formula Elecare®|Babies will be randomized to received either elemental formula (Elecare®) or partially hydrolyzed formula (Pregestimil®) if breast milk is not available.
16135773|NCT01891279|Other|partially hydrolyzed formula|Babies will be randomized to received either partially hydrolyzed formula (Pregestimil®) or elemental formula (Elecare®)if breast milk is not available.
16135774|NCT01891266|Procedure|Non-tourniquet assisted TKA|The intervention group will undergo non-tourniquet assisted total knee arthroplasty, which means that blood flow to the lower limb is maintained throughout surgery.
16135775|NCT01891266|Procedure|Tourniquet assisted TKA|The procedure involves the use of a tourniquet around the thigh. During surgery the tourniquet will be inflated above the systolic blood pressure to ensure a complete bloodless surgical field.
16135776|NCT01891253|Device|non-invasive determination of cardiac output|
16135777|NCT01891227|Drug|Capecitabine|Capecitabine will be dosed at 1000mg/m2 twice daily for 14 days, followed by a 7-day rest period for a total cycle time of 21 days (until disease progression or unacceptable toxic effects).
16135778|NCT01891227|Drug|Bendamustine|Bendamustine 80mg/m2 will be administered on day 1 and 8 of a three week cycle (for a maximum of eight cycles).
16135779|NCT01891214|Other|Validation of the French Version of the Inflammatory Bowel Disease Questionnaire (IBDQ)|
16135780|NCT01891201|Drug|Oxytocin|Comparison of Primitive Newborn Reflexes between those exposed or not to Oxytocin
16135781|NCT01891175|Procedure|Elective caesarean section under spinal anaesthesia.|Patients with scheduled caesarean.
16135782|NCT01891175|Procedure|Elective caesarean section under spinal anaesthesia.|
16135783|NCT01891136|Drug|Peanut protein|Subjects will receive increasing amounts of peanut protein over the modified rush phase and the build-up phase of the protocol. Once the subject reaches the maintenance phase of the study, they will remain on that dose until they reach the oral food challenges at the end of the study.
16135784|NCT01891123|Device|PK guided arm|the dose of PTX or DOC will adjust based on the plasma drug concentration of previous cycle
16135785|NCT01891123|Drug|PTX 175mg/m2, DOC 75mg/m2|patients receive PTX or DOC dose based on body surface area every cycle, PTX 175mg/m2, DOC 75mg/m2
16135786|NCT01891110|Procedure|ES of the abdominal muscles|ES was applied with surface electrodes and fixed stimulation parameters with individual mA, depending on each patients´ sensibility.
16135787|NCT01891110|Procedure|ES of the limb muscles|Lower limb muscles were stimulated to produce a milking mechanism from the distal to proximal part of the limb to pump the venous blood from the peripheral to the central part of the body
16135788|NCT01891110|Procedure|ES of limbs & abdomen|The combination of the ES of the lower limb muscles and the abdominal muscles.
16135789|NCT01891097|Procedure|Acupuncture plus auricular acupuncture|"Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1 , Anmian , Neiguan PC6 , Shenmen HT7 , Sanyinjiao SP6 , and unilateral Yintang EX-HN3 and Baihui GV20. The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.
~Aricular acupuncture at Ear Shenmen, Heart, Kidney, Liver, Spleen, Occiput, and Subcortex.In each treatment borneol crystals will be attached to the left or right side of the ear in alternation with adhesive plaster in each acupuncture treatment visit. Subjects will be asked to press the borneol crystals lightly for five minutes in the morning, afternoon and evening everyday and reminded them to remove the plaster and borneol crystals after 48 hours."
16135790|NCT01891097|Procedure|Acupuncture|Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1 , Anmian , Neiguan PC6 , Shenmen HT7 , Sanyinjiao SP6 , and unilateral Yintang EX-HN3 and Baihui GV20. The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.
16135791|NCT01891084|Drug|Paracetamol|Paracetamol 1 tablet (500mg) four times daily. For a maximum period of 5 days if the patient is still having fever. When required, participants may take up to 2 tablets (1gm) in each dose.
16135792|NCT01891084|Drug|Placebo|(Identical-looking) Placebo 1 tablet four times daily. For a maximum period of 5 days if the patient is still having fever. When required, participants may take up to 2 tablets in each dose.
16135793|NCT01891084|Drug|Backup NSAID ibuprofen|Backup NSAID ibuprofen 200mg orally every 8 hourly will also be provided to all participants, which can be taken when necessary (PRN) if the participant finds the fever intolerable.
16135794|NCT01891071|Procedure|Lung volume recruitment|Inflation of the lungs to their maximal insufflation capacity by the consecutive delivery, by a manual resuscitator in this study, of volumes of air that are held with a closed glottis
16135795|NCT01891058|Device|drug-shock vs shock only|procainamide followed by electrocardioversion if necessary vs cardioversion only.
16135796|NCT01891045|Behavioral|OQ-45.2 no feedback|Completion of the OQ-45.2 before each session, but no feedback to therapists or patients
16135797|NCT01891045|Behavioral|OQ-45.2|Completion of the OQ-45.2 with real-time feedback to the therapist and full use of the suggested interventions every week of the treatment program
16135798|NCT01891019|Drug|Thalidomide oral|Thalidomide will be administered nightly, with each subject taking 2 capsules totaling 100 milligrams for the initial two weeks of treatment, 3 capsules totaling 150 milligrams for week 2 to week 4, and 4 capsules totaling 200 milligrams for week 4 to end of treatment. The subjects will take the medication for 12 weeks.
16135799|NCT01891006|Device|Negative Pressure Wound Therapy|The Negative Pressure Wound Therapy are changed on the 2. day and removed on the 4. day after the re-operation.
16135800|NCT01891006|Other|Standard wound dressing|The standard wound dressing is a a hydrofiber or alginate dressing used for open wounds
16135801|NCT01890993|Drug|liraglutide|Anonymised patient level data will be collected by the patients' own general practitioner and electronic case report form (eCRF) will be used to capture the data.
16135802|NCT01890967|Drug|LY3015014|Administered SC
16135803|NCT01890967|Drug|Placebo|Administered SC
16135804|NCT01890967|Drug|Statin|Administered orally
16135805|NCT01890967|Drug|Ezetimibe|Administered orally
16135806|NCT01890954|Device|Diabetes Assistant (DiAs)|Diabetes Assistance (DiAs) is a software residing in a Smartphone that contains the algorithms to regulate and control insulin deliveries (insulin bolus for: Basal rate, meal insulin and correction bolus) with inputs glucose values from a CGM and outputs insulin infusion by an insulin pump
16135807|NCT01890941|Drug|KCT-0809 ophthalmic solution|
16135808|NCT01890941|Drug|Placebo|
16135817|NCT01890863|Drug|Fluticasone Propionate / Salmeterol Xinafoate DISKUS|Fluticasone propionate and salmeterol xinafoate combination as a dry powder inhaler for oral inhalation with unit dose strength of 100/50 mcg (available in blister pack) administered via DISKUS (Ddpi) device.
16135818|NCT01890863|Drug|Fluticasone Propionate / Salmeterol Xinafoate ROTACAP|Fluticasone propionate and salmeterol xinafoate combination as a dry powder inhaler for oral inhalation with unit dose strength of 100/50 mcg (available in blister pack) administered via ROTAHALER (Rdpi) device.
16135819|NCT01890850|Other|Retrospective database study using administrative claims data|Data collection from OptumInsight proprietary research database which contains enrollment and claims data for individuals enrolled in commercial health plans.
16135820|NCT01890837|Drug|Daikenchuto (TU-100)|Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 2 weeks.
16135821|NCT01890837|Drug|Placebo|Subjects will receive daily dose of TU-100 placebo. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 2 weeks.
16135822|NCT01890811|Dietary Supplement|Boost High Protein|Subjects will receive stable amino acid isotopes IV and will receive Boost High Protein with added isotopes to measure anabolic response to a meal.
16135823|NCT01890798|Drug|Drisapersen|Drisapersen will be supplied as 3 millilitre (mL) vials containing 1mL sterile solution for subcutaneous injection. The strength of drisapersen solution will be 200 mg/mL.
16135824|NCT01890785|Drug|Lisdexamfetamine Dimesylate|Single dose of a 70 mg capsule on Day 1
16135825|NCT01890772|Drug|Telaprevir|
16135826|NCT01890772|Drug|Peginterferon alfa-2a|
16135827|NCT01890772|Drug|Ribavirin|
16135828|NCT01890772|Dietary Supplement|Vitamin D|
16135829|NCT01890759|Biological|Meningococcal Diphtheria Toxoid Vaccine|0.5 mL, Intramuscular
16135830|NCT01890746|Drug|Daunorubicin|For subjects between the ages of 18 and 60 years, 90 mg/m2/day by bolus IV injection through a freshly established free-flowing IV line for 10-15 minutes on days 1, 2, and 3. For subjects > 60 years: daunorubicin dose was adjusted to 60mg /m2.
16135831|NCT01890746|Drug|Cytarabine|100 mg/m2/day continuous IV infusion on Days 1 through 7.
16135832|NCT01890746|Drug|Eltrombopag|200 mg orally, once daily, beginning on Day 4 of the first cycle of induction. After 7 days, the dose of the Investigational Product (IP) was to be increased to 300 mg if platelet counts were <100 Gi/L. IP continued until achievement of platelet count of at least 200 Gi/L or assessment of remission of bone marrow status or a maximum of 42 days after initiation of most recent induction. In subjects of East Asian heritage 100 mg orally once daily (a 50% dose reduction) was used and after 7 days, the dose of IP was increased to 150 mg if platelet counts were <100 Gi/L.
16135833|NCT01890746|Drug|Placebo|Orally, once daily, beginning on Day 4 of the first cycle of induction. After 7 days, the dose given was matching 300 mg Eltrombopag if platelet counts were <100 Gi/L. Placebo continued until achievement of platelet count of at least 200 Gi/L or assessment of remission of bone marrow status or a maximum of 42 days after initiation of most recent induction. In subjects of East Asian heritage placebo matching 100 mg Eltrombopag orally once daily was used and after 7 days, the placebo matching 150 mg Eltrombopag was given if platelet counts were <100 Gi/L.
16135834|NCT01890733|Device|Best Repair of torn Rotator Cuff|
16135835|NCT01890733|Device|InSpace™ system|
16135836|NCT01890720|Device|iNPWT|The Incisional Negative Pressure Wound Therapy (iNPWT) will be applied over the clean closed incision immediately following the operation (caesarean section). In the intervention group the therapy will be left in situ for five days.
16135837|NCT01890720|Other|Standard postoperative wound dressing|A standard wound dressing will be applied over the clean closed incision immediately following the operation (caesarean section). In the control group the dressing will be left in situ for at least 24 hours as standard procedure.
16135838|NCT01890707|Procedure|General Anesthesia|Administer: Fentanyl:1mcg/kg prior to induction, additional doses to maintain blood pressure and heart rate within 20% of preoperative values, Propofol:2mg/kg,succinylcholine, 0.5mg/kg,to be followed with Rocuronium if necessary,bolus: 0.4mg/kg, Sevoflurane and oxygen to be titrated to maintain BIS value of 40-60.
16135839|NCT01890707|Procedure|Deep Sedation|IV administration of Propofol,initial rate 100ug/kg/min, titrated to maintain BIS 65-75,Fentanyl,Ketamine,1mcg/kg,0.5mg/kg,additional 10mg increments for analgesia/movement.
16135840|NCT01890694|Drug|Tolvaptan|15 mg once daily
16135841|NCT01890694|Drug|Placebo|15 mg once daily
16135842|NCT01890694|Behavioral|Hepatic Encephalopathy Assessment|The Number connection test, Digit symbol test, Constructional apraxia, Inhibitory control test, Repeatable Battery for the Assessment of Neuropsychological Status will be administered on Days 1, 2, 4, 6, and 8; discharge day; Weeks 1-4 post-discharge; and Months 2-6 post-discharge.
16135843|NCT01890694|Behavioral|Quality of Life Assessment|The SF-36 and Liver Disease Questionnaire will be administered on Day 1, Discharge day, Weeks 1-4 post-discharge, and months 2-6 post-discharge
16135844|NCT01890694|Biological|Vital signs|Vital signs (blood pressure, heart rate, respiration, temperature, weight, height) will be recorded at every visit.
16135845|NCT01890694|Biological|Blood laboratory tests|Blood laboratory tests (chemistry, hematology, liver function, urine electrolytes, renin, and copeptin) will be recorded at every visit.
16135846|NCT01890694|Procedure|Ascites Evaluation|Ascites will be assessed at every visit.
16135847|NCT01890694|Procedure|Edema|Edema will be assessed at every visit.
16135848|NCT01890681|Behavioral|Baby NAP SACC|
16135849|NCT01890681|Behavioral|Back to Sleep|
16135850|NCT01890668|Other|Osteopathic Manipulative Treatment|"Visit 1 between H60 and discharge :
~Interview (pregnancy step, initiation of breastfeeding, baby posture…) Osteopathic Clinical exam (osteopathic specific diagnosis, mobility…) Osteopathic Manipulative Treatment by sweet osteopathic mobilization Time of intervention = 30 to 45 min Visit 2 : 7 days after visit 1 (+/- 24H) with the same procedure
~To keep the blinded procedure the interventions will be realized behind a screen, allowing interactions with parents but depriving their visibility.
~A telephone contact will be perform at M1 (one month of life) to assess breastfeeding persistence and collect questionnaire data.
~Two others telephone contacts will be perform at 3 months and 6 months to precise breastfeeding interruption date.
~The follow-up for each patient is 6 months"
16135896|NCT01890278|Radiation|Conventional Whole Brain RT|
16135897|NCT01890265|Drug|Pamrevlumab|Solution for infusion
16135851|NCT01890668|Other|No Osteopathic manipulative Treatment|"Visit 1 between H60 and discharge :
~Interview (pregnancy steps, initiation of breastfeeding, baby posture…) Osteopathic Clinical exam and Treatment will not be realized. Newborn will be undressed, lying naked (covered with polar sheet) on the exam table, dissimulated to parents by adequate screen. The osteopathic procedure will take place on a dolly to mimic from an indiscernible manner, osteopathic management.
~Time of intervention = 30 to 45 min Visit 2: 7 days after visit 1 (+/- 24H) with the same procedure.
~To keep the blinded procedure the interventions will be realized behind a screen, allowing interactions with parents but depriving their visibility.
~A telephone contact will be perform at M1 (one month of life) to assess breastfeeding persistence and collect questionnaire data.
~Two others telephone contacts will be perform at 3 months and 6 months to precise breastfeeding interruption date.
~The follow-up for each patient is 6 months"
16135852|NCT01890655|Drug|MT-1303-Low|
16135853|NCT01890655|Drug|MT-1303-Middle|
16135854|NCT01890655|Drug|MT-1303-High|
16135855|NCT01890642|Device|J tip|This is a Jet Injection system which for our study will be loaded with 1% buffered lidocaine
16135856|NCT01890642|Other|Pain Ease Spray|Cold Spray used to anesthetize the skin
16135857|NCT01890642|Drug|1% buffered lidocaine|Lidocaine placed using Jet Injection
16135858|NCT01890642|Other|placebo cooling spray (normal saline spray)|Normal Saline Sprayed as placebo for Pain Ease spray
16135859|NCT01890642|Other|Sucrose|Oral Sucrose used for children < 1 year
16135860|NCT01890629|Drug|Gemigliptin + Metformin / Sitagliptin + Metformin / Glimepiride + Metformin|
16135861|NCT01890616|Device|SmartPill ingestion|The participant would ingest the SmartPill and wear the data receiver for up to 5 days.
16135862|NCT01890603|Other|Data collection|Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected, solely for non-research purposes (such as medical treatment or diagnosis).
16135863|NCT01890603|Other|Data Collection|Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected, solely for non-research purposes (such as medical treatment or diagnosis).
16135864|NCT01890590|Device|CyberKnife|Stereotactic Body Radiation Therapy. 3 or 4 fractions of radiotherapy delivered by Cyberknife.
16135865|NCT01890577|Drug|Aranesp|Observational study; minimum single dose of Aranesp required for eligibility; no protocol-specified regimen; study must not influence normal clinical practice.
16135866|NCT01890564|Other|Pressure controlled ventilation|For pressure controlled ventilation, the peak inflating pressure (PIP) is set for each tidal breath.
16135867|NCT01890564|Other|Volume controlled ventilation|For volume controlled ventilation, the tidal volume is set.
16135868|NCT01890564|Other|PRVC ventilation|Pressure-regulated, volume-controlled (PRVC) is an auto-regulated pressure-controlled mode of mechanical ventilation with a user-selected tidal volume target.
16135869|NCT01890551|Other|Dynamic kine-mri|Dynamic kinematic (KINE) magnetic resonance imaging (MRI) of the patellofemoral joint.
16135870|NCT01890538|Drug|Administration of 100 mg dimenhydrinate intravenous|
16135871|NCT01890538|Drug|2 g piracetam intravenous|
16135872|NCT01890499|Dietary Supplement|Low Residue diet arm.|Interventional arm is to provide low residue diet on postoperative day one.
16135873|NCT01890473|Drug|Abatacept|
16135874|NCT01890447|Other|Web-based survey questionnaire|Data collection will be done via web-based questionnaires generated by Sawtooth Software. Subjects will be asked for their ideal alternative (acceptance to immunisation) by selecting the factors that suit them the most. The subjects are then presented several sets of alternatives built around their ideal choice.
16135875|NCT01890434|Drug|Gadobutrol (Gadavist, Gadovist, BAY86-4875)|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
16135876|NCT01890421|Drug|Gadobutrol (Gadovist, Gadavist, BAY86-4875)|Participants received gadobutrol at the total approved standard dose of 0.1 millimole per kilogram body weight (mmol/kg BW) in 2 separate bolus injections: 0.05 mmol/kg BW at peak pharmacologic stress and 0.05 mmol/kg BW at rest via a power injector.
16135877|NCT01890408|Drug|wound infusion ropivacaine|"Laparotomy Hepatic surgery :
~Bolu of 10 ml de ropivacaine 0,2% + infusion with elastomeric pump with ropivacaine 0,2% at a 10ml/h during 48 hours."
16135878|NCT01890395|Other|Blood draws|Blood sampling collected at 9 timepoints: pre-operative, during surgery X 3, immediately after surgery, 24 hrs post-op, 72 hrs post-op, 5 days and 7 days post
16135879|NCT01890382|Dietary Supplement|Whey protein|30 g in total; twice a day (morning and evening)
16135880|NCT01890382|Dietary Supplement|whey plus creatine|whey protein combined with creatine (30 g and 6.0 g in total; twice a day, respectively)
16135881|NCT01890382|Dietary Supplement|leucine supplementation|7.5 g/d in total; three times per day
16135882|NCT01890382|Dietary Supplement|soy protein|30 g in total; twice a day
16135883|NCT01890382|Dietary Supplement|creatine|6.0 g in total; twice a day
16135884|NCT01890382|Dietary Supplement|placebo|
16135885|NCT01890369|Dietary Supplement|15g Mixed Essential Amino Acids|Dissolved in 250ml water.
16135886|NCT01890369|Dietary Supplement|3g Leucine|Dissolved in 250ml water.
16135887|NCT01890369|Dietary Supplement|15g Mixed Essential Amino Acid REFEED|Dissolved in 250ml water.
16135888|NCT01890356|Device|Transcranial electrical stimulation|
16135889|NCT01890343|Drug|florbetapir 18F|Subjects received a one-time intravenous (IV) bolus injection of 300 megabecquerels (MBq) florbetapir 18F.
16135890|NCT01890343|Drug|18F-FDG|FTD subjects received a one-time IV bolus injection of 185 MBq of 18F-FDG.
16135891|NCT01890330|Other|Canola Oil 25 g/d|Daily consumption of food items containing traditional canola oil (25 g/d) for 12 weeks.
16135892|NCT01890330|Other|Non-Canola Oil Mixture 25 g/d|Daily consumption of food items containing Non-Canola Oil Mixture (25 g/d) representing the typical Western diet for 12 weeks.
16135893|NCT01890317|Procedure|Mild hypothermia|Induction of mild hypothermia with invasive cooling for 24 hr in addition to primary percutaneous coronary intervention and optimal medical therapy.
16135894|NCT01890304|Other|Magnetic Resonance Imaging (MRI)|MRI will be obtained at study entry, following any TBI occuring during sanctioned practice or play, and at study exit.
16135895|NCT01890278|Radiation|Whole Brain IMRT|
16135898|NCT01890265|Drug|Placebo|Solution for infusion
16135899|NCT01890265|Drug|Sub-Study: Pirfenidone|Pirfenidone concomitant therapy will not be provided by the Sponsor.
16135900|NCT01890265|Drug|Sub-Study: Nintedanib|Nintedanib concomitant therapy will not be provided by the Sponsor.
16135901|NCT01890252|Device|Hyper CL|The Hyper CL is hyper osmotic contact lens that absorb fluids from the cornea and by that reduces corneal edema.
16135902|NCT01890252|Drug|saline solution|saline solution of 5% NaCl
16135903|NCT01890239|Other|Care Programme for the Last Days of Life|The Care Programme essentially aims to raise awareness among geriatric health care staff of the importance for improving end-of-life care and to prepare them for a change in end-of-life care, to train staff in delivering good end-of-life care with the support of a multi-professional document called the Care Guide for the Last Days of Life, to support dying geriatric patients with the Care Guide for the Last days of Life, to regularly evaluate the delivered end-of-life care and support and to further educate the staff in delivering optimal end-of-life care. The Care Programme consists of the following documents: (1) the Care Guide for the Last Days of Life, (2) supportive documentation and (3) an implementation guide.
16135904|NCT01890226|Behavioral|Mobile Personal Health Record App.|
16135905|NCT01890213|Biological|AVX701|
16135906|NCT01890200|Drug|Peginterferon alfa-2a|conventional treatment of Hepatitis C
16135907|NCT01890200|Drug|Ribavirin|conventional treatment of Hepatitis C
16135908|NCT01890200|Drug|TCM-700C|An add-on drug to conventional treatment of Hepatitis C
16135909|NCT01890200|Drug|Placebo|Placebo, without acting ingredient.
16135910|NCT01890161|Drug|AXP1275|AXP1275 50 mg (2 × 25-mg capsules)
16135911|NCT01890161|Drug|AXP1275 matching placebo|AXP1275 matching placebo (2 capsules)
16135912|NCT01890148|Drug|AZD5069|oral BD administration of 45 mg AZD5069
16135913|NCT01890135|Drug|Zibotentan (ZD4054)|10 mg
16135914|NCT01890135|Drug|placebo|randomized double blind
16135915|NCT01890122|Drug|Alogliptin|Alogliptin tablets
16135916|NCT01890122|Drug|Metformin HCl|Metformin HCl capsules
16135917|NCT01890122|Drug|Alogliptin and Metformin Fixed-Dose Combination (FDC)|Alogliptin and metformin FDC tablets
16135918|NCT01890122|Drug|Alogliptin Placebo|Alogliptin placebo-matching tablets
16135919|NCT01890122|Drug|Metformin Placebo|Metformin placebo-matching capsules
16135920|NCT01890122|Drug|Alogliptin and Metformin FDC Placebo|Alogliptin and metformin FDC placebo-matching tablets
16135921|NCT01890109|Biological|Erenumab|Administered via subcutaneous injection.
16135922|NCT01890109|Drug|Placebo|Administered via subcutaneous injection
16135923|NCT01890096|Radiation|HDR 2 Fraction|High dose-rate brachytherapy using real-time intra-operative transrectal ultrasound guidance. Patients will receive 27 Gy as a minimal Clinical Target Volume (CTV) dose delivered as two fractions of 13.5 Gy 7-13 days apart. The CTV is the ultrasound defined prostate with a 0-2 mm margin.
16135924|NCT01890096|Radiation|HDR 1 Fraction|High Dose-Rate Brachytherapy delivered in same manner as Arm 1, but to a prescribed CTV minimal dose of 19 Gy in a single fraction
16135925|NCT01890083|Behavioral|Exercise|
16135926|NCT01890083|Behavioral|Health Education|
16135927|NCT01890070|Dietary Supplement|Hazelnuts|Italian hazelnuts from Piedmont with Protected Geographical Indication Certification
16135928|NCT01890070|Dietary Supplement|Chocolate|Extra-dark Italian Chocolate (min. 70% of organic cocoa solids)
16135929|NCT01890070|Dietary Supplement|Red wine|Italian Organic Red Wine
16135930|NCT01890070|Dietary Supplement|Olive Oil|Italian Organic Olive Oil
16135931|NCT01890070|Dietary Supplement|Wild mixed greens|Italian organic wild mixed greens
16135932|NCT01890070|Dietary Supplement|Chestnut|Italian Organic Chestnut
16135933|NCT01890070|Other|No Dietary Supplement|Mediterranean Reference Diet, High Fat Diet, Low Carbohydrate or High Protein Diet without an added dietary supplement (hazelnut, chocolate, red wine, wild mixed greens, chestnuts, olive oil)
16135934|NCT01890057|Drug|Sugammadex|The dose of sugammadex
16135935|NCT01890031|Other|Interactive Cholesterol Advisory Tool|using the virtual clinician computer program for cholesterol information and education.
16135936|NCT01890031|Other|Study physician visits|In-person individual visits with a study physician to give information on cholesterol
16135937|NCT01890018|Behavioral|Electronic Pill Bottle tracking|All 4 groups will use the GlowCaps, a remote monitoring bottle, to take their statin medications
16135938|NCT01890018|Behavioral|Adherence Messaging|Some arms will receive adherence messages if they have not used the Glowcap bottles for 2 of the last 3 days.
16135939|NCT01890018|Behavioral|Social Influence|Some arms will select their own adherence feedback partner who will provide support in taking their medication as scheduled.
16135940|NCT01890005|Drug|Aspirin|Low dose aspirin (100 mg) starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.
16135941|NCT01890005|Drug|Placebo|Placebo starting between 13 and 16 weeks of pregnancy until 36 weeks of pregnancy, taken at night.
16135942|NCT01889992|Radiation|Cardiac MRI|1 month post HTx, year 1 and year 2 annual post HTx eval. CMRIs completed using 1.5-Tesla Whole Body MRI system. Scout images will determine short & long-axis views of the heart. ECG-gated cine MR of 3 long axis and a contiguous short axis orientation will be obtained. T1-weighted delayed enhancement images will be obtained 10 minutes after injection of a gadolinium-based contrast agent. Measurements from each slice will be summed using the method of disks. Myocardial mass will be estimated by multiplying the myocardial wall volume at end diastole by the specific gravity of muscle (1.05gm/ml) and LV hypertrophy will be defined as LV mass indexed to height in meters 2.7 >/=35.8 g/m 2.7) (18). Delayed Gadolinium enhancement will be defined as any enhancement pattern greater than 0%.
16135943|NCT01889992|Procedure|Coronary angiography with IVUS|"Coronary angiography is a test that uses dye and special x rays to show the insides of your coronary arteries. The coronary arteries supply oxygen-rich blood to your heart.
~Intravascular ultrasound is a test that uses sound waves to see inside blood vessels. This article discusses intravascular ultrasound to see inside the coronary arteries, the blood vessels that supply the heart."
16135944|NCT01889992|Other|Cardiac Allograft Remodeling|A surgical procedure in which a diseased heart is replaced with a healthy heart from a deceased person.
16136048|NCT01889160|Drug|AZD4721 Suspension|9 mg/g liquid suspension
16135945|NCT01889992|Drug|M-TOR Immunosuppression|"Sirolimus (INN/USAN), also known as rapamycin, is an immunosuppressant drug used to prevent rejection in organ transplantation; it is especially useful in kidney transplants. It prevents activation of T cells and B-cells by inhibiting their response to interleukin-2 (IL-2).
~Sirolimus dosage based on blood levels."
16135946|NCT01889992|Procedure|Cardiac Biopsy C4D stain|A long, thin tube called a biopsy catheter is inserted through a vein in your neck or grion and guided through your blood vessels to your heart.
16135947|NCT01889992|Genetic|Genetic Mechanism of M-TOR|To identify the molecular and genetic mechanisms associated with development of early post-transplant CAR, and to evaluate the impact of mTOR-inhibitor Sirolimus on this process.
16135948|NCT01889992|Other|Cardiopulmonary Exercise Test (CPET)|The Cardiopulmonary Exercise Test is a highly sensitive, non-invasive stress test. It is considered a stress test because the exercise stresses your body's systems by making them work faster and harder. A disease or condition that affects the heart, lungs or muscles will limit how much faster and harder these systems can work. A CPET assesses how well the heart, lungs, and muscles are working individually, and how these systems are working in unison. Your heart and lungs work together to deliver oxygen to your muscles, where it is used to make energy, and to remove carbon dioxide from your body.
16135949|NCT01889979|Drug|Tramadol|100 mg of Tramadol was applied in the forearm SC (single dose).
16135950|NCT01889979|Drug|Placebo|2 ml of a sterile solution was applied in the forearm SC (single dose).
16135951|NCT01889966|Drug|Sildenafil|oral Sildenafil 3 x 20 mg for 90 days
16135952|NCT01889953|Other|EUS-guided biliary drainage|"Based on the patient's condition, the will receive:
~Rendezvous technique
~Direct transluminal access transesophageal technique
~Direct transluminal access transduodenal technique
~or direct transluminal access using transgastric approach"
16135953|NCT01889940|Behavioral|Training for professionals (Spinal Cord Injury Unit staff).|"Prior to the training, separate focus groups for professionals, patients & families are conducted to determine each party's needs and worries.
~Tailored training for professionals (customized according to focus groups contents) consists of 12 hours distributed in 2 days (1 day per week). It includes theoretical and practical exercises on early detection of PD, communication skills, management of psycho-emotional reactions, family interventions and teamwork alternatives. Standard motivational interviewing techniques for improving empathy skills and communication styles are employed.
~Additionally, optional on-demand small group or individual coaching sessions (after training) will be offered (50-60 minutes per session) during a 6-months period."
16135954|NCT01889927|Other|Exercise Intervention|The exercise intervention will include aerobic, anaerobic, strength, core conditioning and stretching components.
16135955|NCT01889914|Drug|2 different procedures of administration of insulin|Compare the efficiency of both types of therapeutic care in insulinoresistant type 2 diabetic patients: insulin multi injections (levemir et Apidra versus continuous infusion of insulin apidra by pump
16135956|NCT01889888|Other|Submucosal injection of ADRC|Subjects will undergo liposuction under local anesthesia. Lipoaspirate will be processed to isolate and concentrate ADRCs. Patients will undergo mechanical dilation followed by submucosal periurethral ADRC injections circle-wise into stricture site under endoscopic vision.
16135957|NCT01889875|Drug|"ALK Grazax 75,000 SQ-T Phleum pratense"|
16135958|NCT01889875|Drug|"ALK AluTard 225 Phleum pratense"|
16135959|NCT01889862|Drug|BMN165 20mg/day|BMN165 20mg/day self-administered daily
16135960|NCT01889862|Drug|BMN165 40mg/day|BMN165 40mg/day self-administered daily
16135961|NCT01889862|Drug|Placebo|Non-drug placebo, self-administered daily
16135962|NCT01889849|Drug|BIP 48|Volunteers will be randomized into two groups, and each one will receive the two products in two stages separated by at least 4 weeks.
16135963|NCT01889849|Drug|Pegasys|Volunteers will be randomized into two groups, and each one will receive the two products in two stages separated by at least 4 weeks.
16135964|NCT01889836|Biological|'MenCC-Bio'|The experimental group will receive one dose of meningococcal C vaccine adsorbed produced by Bio-Manguinhos.
16135965|NCT01889836|Biological|MENJUGATE|The control group will receive one dose of meningococcal C vaccine adsorbed - MENJUGATE.
16135966|NCT01889823|Other|Hypoxia|Subjects will be breathing an individualized mix of nitrogen and room air titrated to an oxygen saturation of 80-85%.
16135967|NCT01889823|Other|Hyperoxia|Subjects will be breathing 100% oxygen
16135968|NCT01889810|Dietary Supplement|Vitamin D3 supplementation|3000IU (75µg) vitamin D3 will be given daily for a period of 26 weeks to the group who receive the active comparator. The efficacy of vitamin D3 supplementation on insulin resistance will be compared to the placebo group.
16135969|NCT01889797|Biological|Arm A: Rituximab|Rituximab 375 mg/m² IV x 4 weekly doses.
16135970|NCT01889797|Biological|Arm B: GA101|GA101 1,000 mg (flat dose) IV x 4 weekly doses.
16135971|NCT01889784|Device|Phototherapy through light emitting diode (LED) - 150J|The near-infrared radiation by light emitting diode (LED) will be performed with a cluster multi-diode arranged in an array of 34x18 cm containing 50 LEDs (GaAlAs, 850 nm). The phototherapy will be applied bilaterally on femoral quadriceps and triceps surae muscles during 40 seconds with 3J of total energy for each diode and 150 J of total energy delivery to muscle. Neither subject nor evaluators will known if LED was effective or placebo during data collection. A hidden button in the LED device is employed to ensure the double-blind procedure. This button allows selecting placebo or effective emission of near-infrared radiation while the time display is working. This button will be selected by a researcher who just participated of randomization procedure and LED application and had no access to data collection.
16135972|NCT01889784|Device|Placebo phototherapy - 150J|The near-infrared radiation by light emitting diode (LED) will be performed with a cluster multi-diode arranged in an array of 34x18 cm containing 50 LEDs (GaAlAs, 850 nm). The phototherapy will be applied bilaterally on femoral quadriceps and triceps surae muscles during 40 seconds with 3J of total energy for each diode and 150 J of total energy delivery to muscle. Neither subject nor evaluators will known if LED was effective or placebo during data collection. A hidden button in the LED device is employed to ensure the double-blind procedure. This button allows selecting placebo or effective emission of near-infrared radiation while the time display is working. This button will be selected by a researcher who just participated of randomization procedure and LED application and had no access to data collection.
16136156|NCT01888315|Device|Renal denervation with Paradise Recor|Renal denervation using CE-marked devices will be performed according to best medical practice.
16135973|NCT01889784|Device|Phototherapy through light emitting diode (LED) - 300J|The near-infrared radiation by light emitting diode (LED) will be performed with a cluster multi-diode arranged in an array of 34x18 cm containing 50 LEDs (GaAlAs, 850 nm). The phototherapy will be applied bilaterally on femoral quadriceps and triceps surae muscles during 80 seconds with 6J of total energy for each diode and 300 J of total energy delivery to muscle. Neither subject nor evaluators will known if LED was effective or placebo during data collection. A hidden button in the LED device is employed to ensure the double-blind procedure. This button allows selecting placebo or effective emission of near-infrared radiation while the time display is working. This button will be selected by a researcher who just participated of randomization procedure and LED application and had no access to data collection.
16135974|NCT01889784|Device|Placebo phototherapy - 300J|The near-infrared radiation by light emitting diode (LED) will be performed with a cluster multi-diode arranged in an array of 34x18 cm containing 50 LEDs (GaAlAs, 850 nm). The phototherapy will be applied bilaterally on femoral quadriceps and triceps surae muscles during 80 seconds with 6J of total energy for each diode and 300 J of total energy delivery to muscle. Neither subject nor evaluators will known if LED was effective or placebo during data collection. A hidden button in the LED device is employed to ensure the double-blind procedure. This button allows selecting placebo or effective emission of near-infrared radiation while the time display is working. This button will be selected by a researcher who just participated of randomization procedure and LED application and had no access to data collection.
16135975|NCT01889771|Drug|Nicotine Patch|nicoderm patches are distributed in two different supplies through a telephone quitline
16135976|NCT01889758|Drug|Prograf|Brand: Prograf Capsules, 1.0mg Tacrolimus capsules containing white to off white powder equivalent to 1.0 mg of anhydrous tacrolimus are hard gelatin capsules with white opaque body and ivory capsules.
16135977|NCT01889758|Drug|Tacrolimus|Generic Hi: Generic tacrolimus Capsules, 1.0mg. Manufacturer to be determined (Aim 1).
16135978|NCT01889758|Drug|Tacrolimus|Generic Lo: Generic tacrolimus Capsules, 1.0mg. Manufacturer to be determined (Aim 1).
16135979|NCT01889745|Drug|HX-1171|Anti-oxidatant, Anti-inflamation
16135980|NCT01889732|Device|ROTEM|
16135981|NCT01889719|Biological|MVA-CMDR|injections of MVA-CMDR vaccine
16135982|NCT01889680|Drug|5-FU|400 mg/m2 IV bolus day 1 followed by 2400 mg/m2 continuous IV infusion over 46 hours (days 1 and 2) every 14 days until disease progression
16135983|NCT01889680|Drug|LV|400 mg/m2 IV day 1 every 14 days until disease progression
16135984|NCT01889680|Drug|ziv-aflibercept|4 mg/kg IV day 1 every 14 days for 6 cycles (induction regimen); 4 mg/kg IV day 1 every 14 days until disease progression (continuation regimen)
16135985|NCT01889680|Drug|mFOLFOX6|5-FU 400 mg/m2 IV bolus plus leucovorin 400 mg/m2 IV plus oxaliplatin 85 mg/m2 IV on day 1 followed by 5-FU 2400 mg/m2 continuous IV infusion over 46 hours (days 1 and 2) every 14 days
16135986|NCT01889667|Drug|ORMD-0801 Dose # 1|Oral Insulin Formulation
16135987|NCT01889667|Drug|ORMD-0801 Dose # 2|Oral Insulin Formulation
16135988|NCT01889667|Drug|Placebo|Oil Capsules
16135989|NCT01889654|Other|Venous blood sampling|
16135990|NCT01889628|Dietary Supplement|Liquid-based Nutritional Formulae and liquid glucose|
16135991|NCT01889615|Other|PET/CT(3hours]|Low dose PET/CT 1 and 3 hours after injection of FDG, followed by a diagnostic CT with iv contrast
16135992|NCT01889602|Drug|Lorazepam|Lorazepam: 2mg, po, 1x
16135993|NCT01889602|Other|Placebo|Non-active placebo, po, 1x
16135994|NCT01889602|Drug|Topiramate 100mg|Topiramate: 100 mg, po, 1x
16135995|NCT01889602|Drug|Topiramate 150mg|Topiramate: 150 mg, po, 1x
16135996|NCT01889602|Drug|Topiramate 200mg|Topiramate: 200 mg, po, 1x
16135997|NCT01889589|Other|Surveillance|
16135998|NCT01889576|Dietary Supplement|Magnesium Oxide|
16135999|NCT01889563|Other|Physical Exercise Training Program Exercise|Physical Exercise Training Program Exercise training was conducted in three times a week, during 12 weeks at high-intensity targets. Each session consisted of a five minute warm up (walking) at 2 km/h and 30 minutes with an intensity targets set at 70% of the peak speed rate. The increase of intensity was 0.5Km/h when the patient scored less than 4 point of Borg scale (moderate to intense effort) during each session. All evaluations were done at 6th week, in order to analyze the progression of outcomes and exactly adjust the intensity of training.
16136000|NCT01889550|Behavioral|Access to the website www.graviditetsportalen.dk|The website www.graviditetsportalen.dk contains information about the screeningtest for Downs syndrome. The website uses both text, video and animated graphics.
16136001|NCT01889550|Behavioral|Access to the website www.ouh.dk|Access to the usual information from the hospital website
16136002|NCT01889537|Behavioral|Virtual Reality|The patient will receive virtual reality during a burn care procedure
16136003|NCT01889524|Other|Mesh nebulizer|VMN (NIVO, Respironics®, Murrysville, Pennsylvania, USA) with an MMAD of 3.0 µm was placed in the elbow adapter at the mask. Inhalation was performed using diethilene triamine penta-acetic technetium (99mTc-DTPA) with radioactivity of 25 millicuries (Nobre et al., 2007). Both nebulizers were charged with 2.5 mg of salbutamol and 0.25 mg of ipratropium bromide and normal saline solution to complete a fill volume of 3 mL.
16136004|NCT01889524|Other|Jet nebulizer|"The JN (Misty Max, Air Life, Yorba Linda, USA) with a particle MMAD of 5 µm (according to the manufacturer information) was positioned in the circuit using a T piece placed between the circuit leak and the mask, and operated with oxygen flow at 8 L/min. Inhalation was performed using diethilene triamine penta-acetic technetium (99mTc-DTPA) with radioactivity of 25 millicuries (Nobre et al., 2007). Both nebulizers were charged with 2.5 mg of salbutamol and 0.25 mg of ipratropium bromide and normal saline solution to complete a fill volume of 3 mL."
16136005|NCT01889524|Other|Noninvasive ventilation-NIV|Bilevel positive airway pressure (BiPAP Synchrony, Respironics®, Murrysville, Pennsylvania, USA) was applied through face mask (Comfort Full 2, Respironics®, Murrysville, Pennsylvania, USA) attached with straps and pressure adjusted to12 cmH2O peak inspiratory pressure and 5 cmH2O of expiratory pressure at the beginning of the procedure. Patients were adapted to use NIV before starting measurements, pressures were titrated before reaching the established levels and just after this period masks were fitted using the straps. They were oriented to use a breathing pattern inspiring deeply and exhaling slowing to avoid ventilator-patient asynchrony.
16136157|NCT01888315|Device|Renal denervation with V2 Vessix|Renal denervation using CE-marked devices will be performed according to best medical practice.
16136006|NCT01889511|Behavioral|Intervention group - texts|"Patients will be instructed to respond to the text message by sending a text stating if the oral agent was taken. If there is no response after 15 minutes, a second text message will be sent out, again requesting a response. Satisfaction surveys will occur in the intervention group at week 5 when the text messages end; and will take five minutes."
16136007|NCT01889498|Drug|Acetazolamide|"Acetazolamide twice a day, at 12 hour intervals:
~250 mg Tablets; one tablet to be taken twice daily from three days before the day of surgery
~One tablet to take two hours before surgery
~500mg Intravenous Acetazolamide; to be administered upon arrival in critical care post-surgery; continuing at 12 hour intervals until last acetazolamide administration at 72 hours."
16136008|NCT01889472|Device|Nasal mask and oral appliance vs oro-nasal mask during autoCPAP therapy|
16136009|NCT01889446|Dietary Supplement|Calcium propionate|
16136010|NCT01889433|Drug|Algeron|1.5 µg/kg of body weight subcutaneously, once a week
16136011|NCT01889433|Drug|Pegasys|180 µg subcutaneously, once a week
16136012|NCT01889420|Drug|Combination therapy|"Following determination of the maximum tolerated dosages in the phase I portion of this study, all patients enrolled in the extension portion will receive the predetermined dosage combination of pomalidomide, everolimus and dexamethasone.
~Cycles will span 28 days. Dosage schedules will be:
~Everolimus daily for 28 days of a 28 day cycle;
~Pomalidomide daily for 21 days of a 28 day cycle
~Dexamethasone once weekly (on days 1,8,15,22) of a 28 day cycle."
16136013|NCT01889407|Drug|Idarubicin|8 mg/m2, iv drip on days 1-3
16136014|NCT01889394|Procedure|secondary wound healing|secondary wound healing
16136015|NCT01889394|Procedure|primary wound closure using a limberg flap|primary wound closure using a limberg flap
16136016|NCT01889381|Drug|Bone marrow cell-based therapy & 1-drug immunosuppression.|This protocol uses a novel bone marrow cell-based therapy for composite tissue allotransplantation (CTA) rather than conventional triple-drug immunosuppression to facilitate long-term graft survival of deceased donor human faces under low-dose maintenance immunosuppression. Initial T-cell depletion with alemtuzumab is followed by upper extremity transplantation and tacrolimus maintenance therapy. Donor bone marrow cells are infused on Day 10 (±4 days) post-transplantation to elicit a host alloimmune response triggering exhaustion and deletion of the respective host (anti-donor) lymphocyte clones. Subsequently, tacrolimus therapy is given for at least 6 months before spaced weaning is considered in stable recipients.
16136017|NCT01889368|Dietary Supplement|Grape Seed Extract|300 mg capsule of Grape Seed Extract; 1 capsule will be consumed for an acute post-prandial study day and 1 capsule will be consumed daily for 30 days.
16136018|NCT01889368|Dietary Supplement|Placebo|300 mg capsule of maltodextrin; 1 capsule will be consumed for an acute post-prandial study day and 1 capsule will be consumed daily for 30 days.
16136019|NCT01889355|Device|AgaMatrix Blood Glucose Monitor|
16136020|NCT01889342|Behavioral|Metacognitive therapy|
16136021|NCT01889342|Behavioral|Cognitive behavioral therapy|
16136022|NCT01889329|Dietary Supplement|RUTF-1|Made from local food ingredients
16136023|NCT01889329|Dietary Supplement|RUTF-2|Made from local food ingredients
16136024|NCT01889329|Dietary Supplement|Plumpynut|Commercially made from peanut paste
16136025|NCT01889316|Device|Novii|The Novii is a modified device with similar technology to the AN24 device already being used in the USA.
16136026|NCT01889316|Device|AN24|
16136027|NCT01889303|Drug|DC|"Docetaxel plus cisplatin chemotherapy regimen was delivered as chemotherapy and concurrent chemoradiotherapy.
~chemotherapy regimen: Docetaxel（Qilu Pharma. China） 75mg iv D1, Cisplatin（Qilu Pharma. China） 75mg iv D1 ,Q3W for 2 cycles, then Docetaxel 35mg iv D1, Cisplatin 25mg iv D1,QWx4 cycles(but rest in the 4th week during RT) + RT 45Gy( 5weeks) for concurrent chemoradiotherapy→ Rest for 4 weeks → Docetaxel 75mg iv D1,Cisplatin 75mg iv D1 ,Q3W for 2 cycles."
16136028|NCT01889303|Drug|concurrent chemoradiotherapy with 5-FU/CF|"FOLFOX6 regiment was delivered as adjuvant chemotherapy and 5-FU/CF as concurrent chemotherapy treatment.
~Adjuvant chemotherapy: FOLFOX6 regiment : Oxaliplatin（Hengrui Medicine Co., Ltd，China） 85mg/m2 IV d1, Leucovorin （Hengrui Medicine Co., Ltd，China）400mg/m2 IV d1, 5-FU（Hengrui Medicine Co., Ltd，China） 400mg/m2 IV bolus d1, followed with 2400mg/m2 over 46h continuous infusion Q2Wx3 cycles of chemotherapy Concurrent chemotherapy : 5-FU 400mg/m2 IV and Leucovorin 20mg/m2 IV were given on the first four and the last three days in the period of radiotherapy. After radiation, patients will have a rest lasting for 4 weeks and then given Folxof6 regiment chemotherapy for 3 cycles."
16136029|NCT01889303|Radiation|adjuvant radiation|Therapy plan system was formulated by CT simulation. Radiation was delivered with 15MV photons. Radiotherapy consisted of 45Gy of radiation at 1.8Gy/day, five days per week for 5 weeks, to the tumor bed, to the margins of resection, to the regional nodes. Protection of spinal cord, heart, liver and kidney should be considered.
16136030|NCT01889290|Drug|Methylnaltrexone|Methylnaltrexone 12mg s.c. administered once daily until treatment stop of sufentanyl
16136031|NCT01889277|Drug|MT-3995-Low|
16136032|NCT01889277|Drug|MT-3995-High|
16136033|NCT01889277|Drug|Placebo|
16136034|NCT01889264|Other|Observational|Observational, Translational non-treatment study
16136035|NCT01889251|Drug|Ocriplasmin|
16136036|NCT01889251|Drug|Sham injection|
16136038|NCT01889212|Other|11C-erlotinib PET/CT|
16136039|NCT01889199|Drug|Flutamide|Flutamide 125 mg orally each 28 day cycle for 6 cycles
16136040|NCT01889199|Other|Placebo|Placebo orally each 28 day cycle for 6 cycles
16136041|NCT01889186|Drug|ABT-199|Tablet
16136042|NCT01889173|Drug|TNX-102 SL Tablets at 2.8 mg|1 x TNX-102 SL Tablet (with potassium phosphate) at 2.8 mg held under the tongue until dissolution, without swallowing or chewing it.
16136043|NCT01889173|Drug|TNX-102-B SL Tablets at 2.8 mg|1 x TNX-102-B SL Tablet (with sodium phosphate) at 2.8 mg held under the tongue until dissolution, without swallowing or chewing it.
16136044|NCT01889173|Drug|TNX-102-C SL Tablets at 2.8 mg|1 x TNX-102-C SL Tablet (with trisodium citrate) at 2.8 mg held under the tongue until dissolution, without swallowing or chewing it.
16136045|NCT01889173|Drug|Cyclobenzaprine tablets|1 x 5 mg cyclobenzaprine tablet, swallowed with 240 mL of room-temperature water
16136046|NCT01889160|Drug|AZD4721 Solution|1-9 mg/mL liquid solution
16136047|NCT01889160|Drug|AZD4721 Placebo|Liquid solution
16136049|NCT01889147|Biological|hRESCAP|one acute bolus administration of different dosages of hRESCAP (microdose, part 1; and FIH: low dose, 414 µg; medium dose, 2480 µg; high dose, 5300 µg; part 2)
16136050|NCT01889147|Biological|Placebo|
16136051|NCT01889134|Drug|Sedron (alendronate)|
16136052|NCT01889134|Procedure|Parathyroidectomy|
16136053|NCT01889121|Behavioral|Structured psychosocial intervention|This is retrospective analysis of two groups of opiate-addicted pregnant women: 1) Pregnant women in methadone maintenance program 2) Pregnant women in methadone maintenance program AND structured psychosocial intervention
16136054|NCT01889108|Behavioral|SPEEDI|Behavior intervention combining parent education and physical therapy intervention for preterm infants
16136055|NCT01889095|Drug|BIAsp 30|patients receiving variable doses of Insulin BIAsp 30.start with 0.2 to 0.6unit per kg
16136056|NCT01889095|Drug|NPH/Reg|patients receiving Variable doses Of Insulin NPH Start with 0.2 to 0.6 unit per kg
16136057|NCT01889082|Behavioral|Behavioral Weight Loss Intervention for Young Adults|
16136058|NCT01889069|Drug|Rituximab|Rituximab will be administered at a dose of 1400 mg SC once a month for at least 4 doses during the Induction period, and at a dose of 1400 mg SC once every two months for at least 6 doses during the Maintenance period.
16136059|NCT01889069|Drug|Cyclophosphamide|Cyclophosphamide will be administered as per standard local practice as a part of standard chemotherapy regimen.
16136060|NCT01889069|Drug|Vincristine|Vincristine will be administered as per standard local practice as a part of standard chemotherapy regimen.
16136061|NCT01889069|Drug|Doxorubicin|Doxorubicin will be administered as per standard local practice as a part of standard chemotherapy regimen.
16136062|NCT01889069|Drug|Prednisone|Prednisone will be administered as per standard local practice as a part of standard chemotherapy regimen.
16136063|NCT01889069|Drug|Bendamustine|Bendamustine will be administered as per standard local practice as a part of standard chemotherapy regimen.
16136064|NCT01889056|Drug|Erythropoietin (Epoetin beta)|
16136065|NCT01889056|Drug|Placebo|0.9% sodium chloride solution
16136066|NCT01889017|Other|patient questionnaire (tablet pc based)|
16136067|NCT01889004|Drug|Dexmedetomidine|Escalating concentrations until loss of responsiveness
16136068|NCT01889004|Drug|Propofol|Escalating concentrations until loss of responsiveness
16136069|NCT01888991|Other|Glucose Preload and Exercise Intervention|A glucose preload and exercise were administered to examine the modulate substrate oxidation
16136070|NCT01888978|Drug|Gem-OX|
16136071|NCT01888978|Drug|Gem-5FU|
16136072|NCT01888978|Drug|Gem-Tax|
16136073|NCT01888978|Drug|Modified FOLFOX-6|
16136074|NCT01888978|Drug|Ox-Tax|
16136075|NCT01888978|Drug|FOLFIRI|
16136076|NCT01888978|Drug|Tax-Iri|
16136077|NCT01888965|Drug|Dovitinib|"All patients in the study will receive Dovitinib, 500 mg orally daily for 5 days followed by 2 days off (7 day cycles) for up to 2 years.
~If 500 mg is intolerable, 400 mg will be dosed. If 400 mg is intolerable, 300 mg will be dosed"
16136078|NCT01888952|Drug|Prednisone|Patients may receive additional courses of treatment with prednisone (and roflumilast) at the discretion of the investigator if they did not experience unacceptable toxicity and have stable disease or objectively responding disease.
16136079|NCT01888952|Drug|Roflumilast|Patients may receive additional courses of treatment with roflumilast (and prednisone) at the discretion of the investigator if they did not experience unacceptable toxicity, and have stable disease or objectively responding disease.
16136080|NCT01888939|Other|Walking on a Treadmill|
16136081|NCT01888939|Other|Sedendary Activities Only|
16136082|NCT01888900|Drug|DUAL|Asunaprevir and Daclatsvir
16136083|NCT01888900|Drug|QUAD|Asunaprevir, daclatsvir, peginterferon and ribavirin
16136084|NCT01888887|Other|Cetaphil Daily Facial Cleanser|
16136085|NCT01888874|Drug|GLPG0634|GLPG0634 capsules.
16136086|NCT01888874|Drug|Placebo|Placebo capsules.
16136087|NCT01888861|Dietary Supplement|alpha-lipoic acid|the patients in this arm receive 900mg alpha-lipoic acid through NG tube.
16136088|NCT01888861|Drug|placebo|the patients in this arm were received 900mg placebo through NG tube.
16136089|NCT01888848|Dietary Supplement|Freeze-dried Blueberry|12g freeze-dried blueberry (powder), twice daily with water, for 90 days
16136090|NCT01888848|Dietary Supplement|Blueberry Placebo|12g blue, blueberry-flavored powder, twice daily with water, for 90 days
16136091|NCT01888835|Drug|Mirtazapine|
16136092|NCT01888835|Drug|Placebo|
16136093|NCT01888822|Drug|Ciprofloxacin|Prophylactic ciprofloxacin infusion before elective laparoscopic cholecystectomy
16136094|NCT01888822|Drug|Ampicillin-sulbactam|Prophylactic ampicillin-sulbactam infusion before elective laparoscopic cholecystectomy
16136095|NCT01888822|Drug|Placebo|Prophylactic placebo infusion before elective laparoscopic cholecystectomy
16136096|NCT01888809|Behavioral|Comprehensive preventive services|Combined evidence-based services:Parents as Teachers Home visitation, Child-Parent Psychotherapy, and/or Interpersonal Psychotherapy with outreach support
16136097|NCT01888809|Behavioral|Screening and referral|
16136098|NCT01888796|Drug|Linagliptin|
16136099|NCT01888796|Drug|placebo|
16136100|NCT01888783|Other|Tactile acuity measured by 2PD and the GOT|"For a detailed description of the methods see outcome measures"
16136101|NCT01888757|Drug|Lamotrigine|Lamotrigine Extended Release Tablets, 25mg, 50mg, 100mg, 200mg and 300 mg
16136102|NCT01888744|Drug|GnRH agonist|
16136103|NCT01888744|Drug|GnRH antagonist|
16136104|NCT01888744|Drug|hP-hMG|
16136105|NCT01888744|Drug|Human chorionic gonadotropin|induction of final oocyte maturation
16136106|NCT01888744|Drug|Progesterone|
16136107|NCT01888731|Drug|Lamotrigine|Lamotrigine Extended Release Tablets, 25mg, 50mg, 100mg, 200mg and 300 mg
16136108|NCT01888718|Drug|Fexofenadine Hydrochloride|Fexofenadine Hydrochloride Orally Disintegrating Tablets 30 mg
16136109|NCT01888679|Procedure|Head movement|Head movement in extension, flexion, right and left rotation
16136158|NCT01888302|Drug|Cisplatin|Given IV
16136159|NCT01888302|Drug|Gemcitabine Hydrochloride|Given IV
16136160|NCT01888302|Other|Quality-of-Life Assessment|Ancillary studies
16136110|NCT01888653|Behavioral|Attention Bias Modification (ABM)|The training protocol consisted of 160 trials per session with 120 angry-neutral and 40 neutral-neutral trials. Each participant was trained with an alternative set of faces to the one used in the assessment task (i.e. if measured with set A then trained with set B and vice-versa). In the ABM condition, training was contin- gent on the bias measured at pre-treatment. Specifically, for those showing a bias toward the threat, the target appeared at the neutral-face location in 100% of the threat-neutral trials, while for those showing a bias away from the threat, the target appeared at the threat-face location in 100% of the threat-neutral trials.
16136111|NCT01888653|Behavioral|Attention control training (ACT)|In the ACT condition, threat- face location, probe location, and probe type were fully counter- balanced with no contingency between face valence and probe location, thus resembling the assessment task.
16136112|NCT01888640|Device|TENS|"TENS Parameters: Active TENS and Placebo TENS
~TENS Frequency - 2-125 Hz
~TENS Pulse Width - 200 µs
~TENS Intensity - Maximal tolerable intensity
~Duration: 2 hours per day. The 2 hours may be broken into smaller segments of time with a minimum of 30 minutes.
~Administration - Daily
~TENS Location: TENS electrode on the skin will be a 4 x 7 butterfly electrode to the cervical and lumbar region.
~Placebo TENS Unit Active TENS unit No TENS - Standard Care"
16136113|NCT01888627|Other|Integrated care|The IC model was implemented into a network of the Psychosis Center of the University hospital (UKE), private psychiatrists of the UKE catchment area and other outpatient facilities. Integrated Care involves ACT treatment within this network. Patients have access to all evidence-based interventions according to need.
16136114|NCT01888588|Drug|Risk of symptomatic peptic ulcer|Current use of drugs (ASA; NSAIDs, SSRI,PPI, H2RA) versus non-use
16136115|NCT01888575|Drug|Risk of low dose aspirin discontinuation|PPI continuous use; No PPI usePPI
16136116|NCT01888562|Drug|Ponatinib|Ponatinib 45 mg daily for 4 weeks (4 weeks equal one cycle)
16136117|NCT01888549|Drug|High-dose PPI|:40mg, po(per oral) 2times.day, 8weeks
16136118|NCT01888549|Drug|standard PPI|: 40mg, po(per oral) 1times.day, 8weeks
16136119|NCT01888549|Drug|placebo|
16136120|NCT01888536|Drug|Limaprost|
16136121|NCT01888536|Drug|Pregabalin|
16136122|NCT01888536|Drug|Placebo(for Pregabalin)|mimic Pregabalin 75mg capsule
16136123|NCT01888536|Drug|Placebo(for Limaprost)|mimic Limaprost tablet
16136124|NCT01888523|Behavioral|Expressive writing|log in to an online survey and writing in the survey about your thoughts and feelings about your cancer. This requires 20-30 minutes of writing a day for 4 consecutive days. You will also provide saliva samples.
16136125|NCT01888523|Behavioral|Everyday experiences writing|log in to an online survey and writing in the survey about your thoughts and feelings about your everyday experiences. This requires 20-30 minutes of writing a day for 4 consecutive days. You will also provide saliva samples.
16136126|NCT01888510|Procedure|computed tomography|Undergo conventional free breathing CT
16136127|NCT01888510|Procedure|4-dimensional computed tomography|Undergo 4D CT
16136128|NCT01888510|Procedure|computed tomography|Undergo ABC CT
16136129|NCT01888510|Procedure|cone-beam computed tomography|Undergo ABC CBCT
16136130|NCT01888510|Procedure|cone-beam computed tomography|Undergo free breathing CBCT
16136131|NCT01888497|Drug|Gabapentin|250 mg, oral, prior to bedtime on the night before performance testing
16136132|NCT01888497|Drug|Diphenhydramine citrate|76 mg, oral, prior to bedtime on the night before performance testing
16136133|NCT01888497|Drug|Triazolam|0.5 mg, oral, prior to bedtime on the night before performance testing
16136134|NCT01888497|Drug|Placebo|Oral, prior to bedtime on the night before performance testing
16136135|NCT01888484|Biological|octanorm 16.5%|octanorm 16.5%, human normal immunoglobulin for subcutaneous (SC) administration.
16136136|NCT01888471|Procedure|Blood sample|Blood sample will be obtained from enrolled mothers at delivery(either immediately before or after delivery) Both original blood sample and cord blood sample will be obtained for serology.
16136137|NCT01888471|Other|Vaginal swab sample|Vaginal swab will be collected at delivery from a pre-defined subset of enrolled mothers for the identification of controls, for determining GBS maternal colonization status and serotype.
16136138|NCT01888458|Drug|Micafungin|All patients meeting selection criteria will receive micafungin IV. Prophylaxis will start within 48 hours of the beginning of the transplant-related conditioning regimen until 5 days after recovery from neutropenia (ANC ≥ 500/µl), or occurrence of an IFI, or up to 42 days, or withdrawal for any reason (e.g. patient's or investigator's decision, development of intolerance, death), whichever come first
16136139|NCT01888445|Drug|roxadustat|oral
16136140|NCT01888445|Drug|darbepoetin alfa|iv
16136141|NCT01888432|Drug|Everolimus + reduced tacrolimus|Everolimus was initiated at Week 4 post transplantation. The dose was adjusted to maintain the everolimus trough blood levels between 3-8 ng/mL for the duration of the study. Tacrolimus was reduced to 3-5 ng/mL.
16136142|NCT01888432|Drug|Standard tacrolimus|Tacrolimus was initiated as soon as possible after transplantation according to approved labeling recommendations. The trough level should've been 5-15 ng/mL until randomization, 8-12 ng/mL from randomization until month 4 and after month 4 until end of study reduced to 6 -10 ng/mL.
16136143|NCT01888419|Other|Lipotransplantation|Lipotransplantation in general anaesthesia to the mastectomy site
16136144|NCT01888406|Behavioral|Guided Self-Help|
16136145|NCT01888406|Behavioral|Pure Self-Help|
16136146|NCT01888393|Drug|lumacaftor 200 mg q12h + ivacaftor 250 mg q12h|
16136147|NCT01888380|Procedure|Minimally invasive, virtual autopsy|Post-mortem cross-sectional imaging with CT-guided biopsy
16136148|NCT01888380|Procedure|Conventional autopsy|
16136149|NCT01888367|Drug|DFA-02 Antibiotic Gel|
16136150|NCT01888367|Drug|DFA-02 Placebo Gel|
16136151|NCT01888354|Drug|H.P. Acthar Gel (repository corticotropin injection)|Acthar Gel 80 IU
16136152|NCT01888341|Drug|Isotretinoin|Isotretinoin Capsules,20 mg
16136153|NCT01888328|Drug|Isotretinoin|Isotretinoin Capsules,40 mg
16136154|NCT01888315|Device|Renal denervation with Symplicity Flex Medtronic/Ardian|Renal denervation using CE-marked devices will be performed according to best medical practice.
16136155|NCT01888315|Device|Renal denervation with EnligHTN St. Jude Medical|Renal denervation using CE-marked devices will be performed according to best medical practice.
16136161|NCT01888302|Drug|Sirolimus|Given PO
16136162|NCT01888289|Drug|Isotretinoin|Isotretinoin Capsules,40 mg
16136163|NCT01888276|Other|evaluation of word generation and of motivation|"Each subject will realize twice each test during 2 sessions with one hour in between :
~During the session 1 :
~The test of words generation, which is to produce action verbs in response to 40 nouns, and noun in response to verbs.
~The test of Stroop that assesses selective attention
~During the session 2:
~The test of words generation, which is to produce action verbs in response to 40 nouns, and noun in response to verbs.
~The task of the casino (Iowa Gambling Test)
~The task of landing
~The test of Stroop"
16136164|NCT01888263|Drug|Lamotrigine|Lamotrigine Extended Release Tablets, 25mg, 50mg, 100mg, 200mg and 300 mg
16136165|NCT01888250|Drug|Lamotrigine|Lamotrigine Extended Release Tablets, 25mg, 50mg, 100mg, 200mg and 300 mg
16136166|NCT01888237|Drug|Double dose of PPI|Lansoprasole (30mg) 2 tab oral BID
16136167|NCT01888237|Drug|sequence of drug use|lansoprazole 30 mg b.d. for 10 days amoxicillin 1000 mg b.d. (day 1 to day 5) metronidazole 400 mg b.d. (day 6-day 10) and clarithromycin 500 mg b.d. (day 6-day 10)
16136168|NCT01888224|Drug|Isotretinoin|Isotretinoin Capsules,40 mg
16136169|NCT01888211|Dietary Supplement|Omega 3 fatty acid supplementation|2 grams Omacor daily
16136170|NCT01888211|Dietary Supplement|Olive Oil|2 grams olive oil daily
16136171|NCT01888198|Behavioral|(EORTC QLQ-C30) questionnaire|
16136172|NCT01888198|Behavioral|EuroQol EQ-5D 7-item questionnaire|
16136173|NCT01888172|Behavioral|Weight Watchers Online Program|Access to the Weight Watchers Online program available via the Internet on personal computers, tablet computers, and smartphones.
16136174|NCT01888172|Device|Philips ActiveLink|Provision of a key-chain sized physical activity monitor that interfaces with the Weight Watchers website to promote exercise and give feedback on progress towards exercise goals.
16136175|NCT01888172|Behavioral|Eating and Activity Newsletter|General information on healthy eating and physical activity habits and the medical consequences of overweight/obesity and weight loss.
16136176|NCT01888159|Procedure|Bilateral Salpingectomy|
16136177|NCT01888159|Procedure|Tubal sterilization with bipolar energy|
16136178|NCT01888146|Behavioral|Interdisciplinary pain program|Interdisciplinary pain program, which includes behavioral health, nurse case management, physical therapy, and pharmacy embedded in primary care.
16136179|NCT01888133|Behavioral|Group Walk|weekly walking club session on Saturday mornings at Boston Common, lasting 30 min - 1 hour and engage in daily physical activity (aiming for 10,000 steps/day or increase number of steps by 500 every 2 weeks)
16136180|NCT01888133|Behavioral|Individual Walk|engage in daily physical activity (aiming for 10,000 steps/day or increase number of steps by 500 every 2 weeks)
16136181|NCT01888120|Drug|Ziconotide|
16136182|NCT01888107|Drug|Risperidone Long-acting Injectable (LAI) 25 mg|Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks.
16136183|NCT01888107|Drug|Risperidone LAI 37.5 mg|Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks.
16136184|NCT01888107|Drug|Risperidone LAI 50 mg|Risperidone LAI will be administered as a gluteal intramuscular injection given every 2 weeks for 52 weeks.
16136185|NCT01888094|Other|Ultrasound-guided cannulation and examination|
16136186|NCT01888081|Drug|A-dmDT390-bisFv(UCHT1) (Resimmune®)|
16136187|NCT01888081|Radiation|Ionizing Radiation|
16136188|NCT01888055|Device|transcranial direct current stimulation|
16136189|NCT01888055|Device|sham stimulation|
16136190|NCT01888042|Drug|Everolimus|10 mg (1 tablet of 10 mg)
16136191|NCT01888029|Device|transcranial direct current stimulation|
16136192|NCT01888029|Device|sham stimulation|
16136193|NCT01888016|Other|fascial manipulation|• 3 manual intervention on deep fascial tissues, according to fascial manipulation technique, providing a specific motor and manual assessment, and a deep manual intervention over specific fascial alteration.
16136194|NCT01888016|Other|standard physiotherapies treatment|"10 standard treatments in 2 weeks
~Deltoid and infraspinatus muscles electrotherapy
~Chair for passive continue mobilization at allowed range of motion (ROM). ½ h per day
~Scar massage
~Upper limb, cervical spine and scapula massages
~Passive and assisted/active shoulder mobilization exercises
~Scapula micro-mobilizations
~Gleno-humeral decoaptation
~Elbow, wrist and hand active mobilization
~Proprioceptive exercise with and without the aid of the mirror"
16136195|NCT01888003|Drug|Iron sucrose|AMG patients will receive a standardized and well-accepted intravenous dose of 200 mg of iron sucrose (Venofer®) at -14 days and -7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females). An additional dose will be given on postoperative day 2.
16136196|NCT01888003|Drug|Epoetin Alfa|AMG patients will receive a standardized and well-accepted subcutaneous dose of 40,000 IU of epoetin alfa (PROCRIT®) plus an intravenous dose of 200 mg of iron sucrose (Venofer®) at -14 days and -7 days before their planned surgery, and if indicated, based upon laboratory testing on the day of their surgery (if patient has a Hgb < 13.0 g/dL and hematocrit between 30% and 39%, for males and females).
16136197|NCT01888003|Other|Blood Transfusion|An evidence-based, goal-directed blood transfusion protocol will be applied in AMG, CTG, and NAG patients during and after their surgical procedure to control for health provider variation in transfusion criteria and practices. This blood conservation protocol will consist primarily of the application of a restrictive transfusion trigger (Hgb < 8 g/dl) (21,22) but will also take into consideration the patient's intraoperative estimated allowable blood loss and hemodynamic stability.
16136198|NCT01887990|Drug|Ketamine|single dose IV 0.2 mg/kg ketamine
16136199|NCT01887990|Drug|placebo|saline infusion
16136200|NCT01887977|Other|MRI examination|The vocal and nasal tracts from the lips and nostrils to the beginning of the trachea are imaged with Siemens Avanto 1.5T MRI machine using carefully optimized, externally triggered imaging sequences that are synchronized with the rest of the experimental setting. A sound sample, given by the test subject, is recorded simultaneously to obtain a coupled data set: the speech sound and the precise anatomy which produces it.
16136201|NCT01887964|Other|RS4 enriched flour|Wheat flour with 30% resistant starch (type-4)
16136202|NCT01887964|Other|Control flour|Wheat flour without resistant starch (type-4)
16136203|NCT01887951|Drug|Penthrox Inhaler|
16136204|NCT01887951|Drug|Tramadol Injection|
16136205|NCT01887938|Biological|HGT-1110|Participants will receive IT injection of HGT-1110.
16136206|NCT01887912|Biological|C. difficile Toxoid Vaccine|0.5 mL, Intramuscular
16136207|NCT01887912|Biological|Placebo: 0.9% normal saline|0.5 mL, Intramuscular
16136208|NCT01887899|Device|transcranial direct current stimulation|
16136209|NCT01887899|Device|sham stimulation|
16136210|NCT01887886|Drug|erlotinib|150 mg orally daily
16136211|NCT01887886|Drug|onartuzumab|15 mg/kg IV every 3 weeks
16136212|NCT01887886|Drug|placebo|IV every 3 weeks
16136213|NCT01887873|Device|Hyaluronan Thiomer i.o. implant|
16136214|NCT01887860|Other|Cetaphil Daily Facial Moisturizer SPF 50|Other: Cetaphil Daily Advance Ultra Hydrating Lotion 0.2ml or 0.2g of Cetaphil on occlusive, hypoallergenic patch applied to skin for 24 hrs 9 times on Monday, Wednesday, and Friday for 3 weeks
16136215|NCT01887847|Drug|Nicotine (Pharmaceutical Productions Inc.)|An investigational 2 mg sublingual nicotine tablet (Pharmaceutical Productions Inc.) will be administered in a randomized crossover design in 6 male and female otherwise healthy smokers.
16136216|NCT01887847|Drug|Nicotine (Pharmaceutical Productions Inc.)|A Commit® 2 mg nicotine lozenge (GlaxoSmith Kline)will be administered in a randomized crossover design in 6 male and female otherwise healthy smokers.
16136217|NCT01887834|Dietary Supplement|Kyodophilus multi-strain probiotic capsules|
16136218|NCT01887834|Dietary Supplement|Kyodophilus Matching Placebo Capsules|
16136219|NCT01887821|Drug|Chloroquine|
16136220|NCT01887821|Drug|Dihydroartemisinin/Piperaquine|
16136221|NCT01887808|Other|Cetaphil DermaControl Oil Control Moisturizer SPF 30|
16136222|NCT01887795|Drug|Erlotinib|
16136223|NCT01887795|Drug|WBRT|
16136224|NCT01887782|Device|HFL rTMS|Magventure Cool B70 Coil with either RX100 or RX30 Stimulator
16136225|NCT01887782|Device|iTBS|Magventure Cool B70 Coil with either RX100 or RX30 Stimulator
16136226|NCT01887756|Device|Tele Rehabilitation|
16136227|NCT01887743|Drug|Pantoprazole|This will be a single dose study where participants will receive 1.2mg/kg or no more than 100mg total one time dose as a liquid containing Carbon 13 labeled Pantoprazole with a final concentration of 4.0mg/mL.
16136228|NCT01887730|Behavioral|Hand washing with soap and water|Can infections be prevented by hand washing with soap and water
16136229|NCT01887730|Behavioral|Hand cleaning with alcohol-containing hand rub|Can infections be prevented by hand cleaning with alcohol-containing hand rub. Effect of intervention is assessed by following occurrence of infections
16136230|NCT01887730|Behavioral|Control|
16136231|NCT01887717|Device|TheraSphere®|Intrahepatic treatment of advanced hepatocellular carcinoma
16136232|NCT01887717|Drug|Sorafenib|Standard of care therapy for treatment of advanced hepatocellular carcinoma
16136233|NCT01887704|Device|Rotablator|Rotablator, Boston Scientific, Maple Grove, MN, USA. Rotablator will be used in the Rotablator arm.
16136234|NCT01887704|Procedure|conventional angioplasty|Conventional angioplasty was used in both arms.
16136235|NCT01887704|Procedure|stenting|Stenting was implanted in both arms.
16136236|NCT01887704|Device|Cutting balloon|Flextome cutting balloon(Boston Scientific, Natick, MA, USA) was used in both arms.
16136237|NCT01887704|Drug|Aspirin|Aspirin will be administrated in participants in both arms.
16136238|NCT01887704|Drug|Clopidogrel|Clopidogrel will be administrated to participants in both arms.
16136239|NCT01887704|Device|Paclitaxel-eluting stent|Paclitaxel-eluting stent will be used in both arms.
16136240|NCT01887704|Device|zotarolimus-eluting stent|Zotarolimus-eluting stent will be implanted in participants in both arms.
16136241|NCT01887704|Device|Everolimus-eluting stent|Everolimus-eluting stent will be used in both arms.
16136242|NCT01887704|Device|Sirolimus-eluting stent|Sirolimus-eluting stent will be used in both arms.
16136243|NCT01887691|Drug|eszopiclone|Eszopiclone at a dose of 1-3 mg (lowest tolerated dose, as determined using a dose escalation schedule and side effect profile)will be taken 30 minutes before bedtime for one week.
16136244|NCT01887678|Drug|Traumeel® / Zeel® Injectable Solution|Injection volume is 4.2 mL for active study medication (2.0 mL Zeel plus 2.2 mL Traumeel in one IA injection) on treatment days 1, 8 and 15.
16136245|NCT01887678|Drug|Placebo|Placebo is an injection of Saline
16136246|NCT01887665|Behavioral|incentives|A structured system of prize-based financial incentives rewards attendance at treatment visits.
16136247|NCT01887652|Other|conventional ovarian stimulation|a protocol of ovarian stimulation with recombinant FSH with dose according to age, ovarian size and previous treatment. In patients alder than 35, recombinant LH was added to ovarian stimulation.
16136248|NCT01887652|Other|individualized ovarian stimulation|After defining cut-off points of anti-mullerian hormone, using a ROC analysis, to discriminate excessive (≥20 oocytes retrieved) and poor response (≤4 oocytes retrieved), a individualized protocol was defined.Mild stimulation using daily doses (112.5 to 150 IU) of recombinant FSH or recombinant FSH combined with recombinant LH supplementation (375 IU total daily dose) were given to patients identified as at risk of excessive and poor response.
16136249|NCT01887626|Drug|Ticagrelor 90 mg whole tablet|Ticagrelor 90 mg whole tablet administered as a single oral dose
16136250|NCT01887626|Drug|Ticagrelor 90 mg tablet crushed|Ticagrelor 90 mg crushed and suspended in water
16136251|NCT01887626|Drug|Dispersed ticagrelor 90 mg tablet suspended in water - nasogastric tube|Dispersed 90 mg ticagrelor 90 mg tablet suspended in water and administered through a nasogastric tube into the stomach
16136252|NCT01887613|Drug|Regnite|oral
16136253|NCT01887600|Drug|Roxadustat|Roxadustat was administered initially according to the tiered weight-based dosing, where participants with weight from ≥ 45 to ≤ 70 kg received 70 mg and participants with > 70 to ≤ 160 kg received 100 mg of roxadustat. Dose-titration based upon regular measurement of Hb levels was performed until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline (BL) of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL.
16136329|NCT01887119|Other|Placebo|Eplerenone-matched placebo
16136613|NCT01884987|Drug|GM1|This group will be treated with GM1 80mg daily for 14 days, and then followed with GM1 40mg daily for 46 days.
16136254|NCT01887600|Drug|Placebo|Placebo was administered initially according to the tiered weight-based dosing, where participants with weight from ≥ 45 to ≤ 70 kg received 70 mg and participants with > 70 to ≤ 160 kg received 100 mg of roxadustat. Dose-titration based upon regular measurement of Hb levels was performed until participants achieved central Hb value of ≥ 11.0 g/dL and Hb increase from baseline (BL) of ≥ 1.0 g/dL at two consecutive study visits, separated by at least 5 days. Once target Hb level was reached participants entered maintenance period during which roxadustat dosage was adjusted every 4 weeks to maintain participants Hb level within the target range of 10.0 g/dL and 12.0 g/dL.
16136255|NCT01887587|Drug|MLN9708|
16136256|NCT01887587|Drug|Vincristine|
16136257|NCT01887587|Drug|Doxorubicin|
16136258|NCT01887587|Drug|Dexamethasone|
16136259|NCT01887574|Other|questionnaire|questionnaires given to all patients to assess risk factors and quality of life
16136260|NCT01887561|Drug|dasatinib|
16136261|NCT01887548|Other|Personality Traits Questionnaires|Patients are required to fill out several personality traits questionnaires. The following personality traits scores would be collected: IBDQ, IBDQ-Emotional function score, IBDQ-Social function score, IBDQ-Bowel function score, IBDQ-Systemic symptom score, Neuroticism score, Lie (social conformity/desirability) score, Hospital anxiety score, Hospital depression score, Buss-Perry score, PA (physical aggression) score, VA (verbal aggression) score, A (anger) score, H (hostility) score.
16136262|NCT01887535|Drug|JNJ-54861911 3 mg|JNJ-54861911 3 mg will be administered as an oral suspension formulation.
16136263|NCT01887535|Drug|JNJ-54861911 10 mg|JNJ-54861911 10 mg will be administered as an oral suspension formulation.
16136264|NCT01887535|Drug|JNJ-54861911 30 mg|JNJ-54861911 30 mg will be administered as an oral suspension formulation.
16136265|NCT01887535|Drug|JNJ-54861911 80 mg|JNJ-54861911 80 mg will be administered as an oral suspension formulation.
16136266|NCT01887535|Drug|JNJ-54861911 25 mg|JNJ-54861911 25 mg will be administered as a solid dose formulation.
16136267|NCT01887535|Drug|Placebo|Matching placebo will be administered as an oral suspension formulation.
16136268|NCT01887522|Drug|Vinblastine + Nilotinib|"Vinblastine: administered in a 15-minute infusion, once weekly on Days 1, 8, 15 and 22 of each 28-day cycle.
~Nilotinib (Tasigna®): orally BID given continuously on Days 1- 28"
16136269|NCT01887522|Drug|Vinblastine|· Vinblastine 6 mg/m2 given in a 15-minute infusion, once weekly on Days 1, 8, 15 and 22 of each 28-day cycle.
16136270|NCT01887509|Device|Probe-based confocal laser endomicroscopy|"Patients will undergo:
~Conventional rectoscopy
~pCLE exam following injection of fluorescein, fluorescent contrast agent
~EUS : echoendoscopy
~Biopsies for histopathology : location identical to those of pCLE
~Tumor resection will be performed according to standard oncologic principles.
~All visible lesions will be documented. Both healthy and tumor tissue will be examined. Location of sites of interest will be documented on a schema, completed with photographs of endoscopic view.
~Biopsies will be harvested in both healthy and tumor tissue as well.
~After all procedures are complete, a second assessment of pCLE images by a third party will be performed."
16136271|NCT01887509|Procedure|Rectoscopy|"Patients will undergo:
~Conventional rectoscopy
~pCLE exam following injection of fluorescein, fluorescent contrast agent
~EUS : echoendoscopy
~Biopsies for histopathology : location identical to those of pCLE - Tumor resection will be performed according to standard oncologic principles.
~All visible lesions will be documented. Both healthy and tumor tissue will be examined. Location of sites of interest will be documented on a schema, completed with photographs of endoscopic view.
~Both healthy and tumor tissue will be examined."
16136272|NCT01887509|Procedure|EUS|"Patients will undergo:
~Conventional rectoscopy
~pCLE exam following injection of fluorescein, fluorescent contrast agent
~EUS : echoendoscopy
~Biopsies for histopathology : location identical to those of pCLE - Tumor resection will be performed according to standard oncologic principles.
~All visible lesions will be documented. Both healthy and tumor tissue will be examined. Location of sites of interest will be documented on a schema, completed with photographs of endoscopic view."
16136273|NCT01887509|Procedure|Biopsy and resection|"Patients will undergo:
~Conventional rectoscopy
~pCLE exam following injection of fluorescein, fluorescent contrast agent
~EUS : echoendoscopy
~Biopsies for histopathology : location identical to those of pCLE
~Tumor resection will be performed according to standard oncologic principles.
~All visible lesions will be documented. Both healthy and tumor tissue will be examined. Location of sites of interest will be documented on a schema, completed with photographs of endoscopic view.
~Biopsies will be harvested in both healthy and tumor tissue as well."
16136274|NCT01887483|Dietary Supplement|Vetal Laban active|Dairy product with probiotic
16136275|NCT01887483|Dietary Supplement|Placebo|Dairy product without probiotic
16136276|NCT01887470|Drug|Full dose preparation|
16136277|NCT01887470|Drug|Split dose preparation|
16136278|NCT01887457|Drug|VFEND|voriconazole will be administered in iv form
16136279|NCT01887444|Dietary Supplement|Lactobacillus reuteri DSM17938 probiotic|Drops suitable for infants. 2 X 5 drops / day will be issued, corresponding to 2.108 CFU Lactobacillus reuteri living DSM17938. The probiotic is contained in a lipid emulsion.
16136280|NCT01887444|Other|Placebo|Drops suitable for infants. 2 X 5 drops / day will be issued, corresponding to the lipid emulsion without probiotics.
16136281|NCT01887431|Other|Telecare|Each patient will transmit glucometer and pump data electronically via a web site (Medtronic Carelink internet site www.carelink.minimed.com) to diabetes team and will receive feedback by telephone. Frequency of data transfer will be directly related to patients' metabolic control. In addition to data transmission Patient of the intervention group will be arriving during the intervention year for 3 clinic visit at the following time point : 0, 6 and 12 month.
16136282|NCT01887431|Other|Conventional therapy|3-month routine clinic visits
16136283|NCT01887418|Drug|QuickShot™ - 50 mg Treatment B|QuickShot™ for the delivery of testosterone
16136284|NCT01887418|Drug|QuickShot™ - 100 mg Treatment A|QuickShot™ for the delivery of testosterone
16136285|NCT01887418|Drug|Delatestryl 200 mg IM Treatment C|Standard of care
16136325|NCT01887145|Procedure|Open surgery|Open carpal tunnel release using conventional open technique under local anesthesia and tourniquet. The incision in the open procedure extended from about 1 cm proximal to 3 cm distal to the wrist crease. The transverse carpal ligament was divided; no additional procedures were performed. a soft dressing was applied. Dressing and sutures were removed 10 days postoperatively.
16136326|NCT01887132|Drug|Donepezil|
16136286|NCT01887405|Drug|Adrenaline auto-injector|"Each subject will be randomly assigned to use either the Jext or EpiPen first. The alternative auto-injector will then be used by the same subject in the second study session.
~Valid for both Jext and Epipen:
~Active ingredients: Adrenaline tartrate Dosage form: Prefilled auto-injector for single use, delivering one intramuscular injection Dose/strength: 150 μg Excipients: Sodium chloride, sodium metabisulphite (E223), hydrochloric acid (for pH adjustment), water"
16136287|NCT01887392|Other|Knowledge Translation Education Sessions|Two interactive sessions will be delivered to the interprofessional team at Month 1 and Month 6 and are 1 hour in length. The Clinical Consultant Pharmacist at each LTC home will lead the Knowledge Translation Sessions. Participants will watch an educational video, developed by the co-investigators with expertise in osteoporosis and geriatrics and members of the Ontario College of Family Physicians. Accompanying materials that support the topics in the video will be provided. Following the educational video, one of the experts from the video will phone the LTC home to address questions and provide the home with direct access to an expert.
16136288|NCT01887379|Drug|GRDF furosemide|The GRDF furosemide tablet contains Fe3O4, which serves as an inactive magnetic marker to allow monitoring of the tablet transit through the gastrointestinal tract, using the MMM imaging technique.
16136289|NCT01887366|Drug|TV-1380 150 mg|Subjects assigned to TV-1380 150 mg will be administered one intra-muscular (IM) injection once weekly over 12 weeks. The injection volume will be the same for all treatment groups. Therefore, to accommodate the volume required for the highest dosing group (3.0 mL), subjects in this group will receive 3.0 mL IM injection of TV-1380 150 mg (1.5 mL TV-1380 and 1.5 mL placebo/diluents).
16136290|NCT01887366|Drug|TV-1380 300 mg|Subjects assigned to TV-1380 300 mg will be administered one intra-muscular (IM) injection once weekly over 12 weeks. Subjects in this treatment group will receive 3.0 mL TV-1380.
16136291|NCT01887366|Drug|Placebo|Subjects assigned to placebo will be administered one intra-muscular (IM) injection once weekly over 12 weeks. Subjects in this treatment group will receive 3.0 mL placebo.
16136292|NCT01887353|Drug|Ranolazine|Patients will take ranolazine 1000 mg tablets twice daily
16136293|NCT01887353|Drug|Placebo|Placebo pill manufactured to mimic ranolazine 1000 mg tablets. Patients will be instructed to take two pills a day.
16136294|NCT01887340|Drug|Carboplatin|"- carboplatine: Dose (mg) = AUC x (GFR + 25)
~GFR : glomérulaire filtration (ml/min)
~AUC : area under curve (mg/ml x min)"
16136295|NCT01887340|Drug|Etoposide|100 mg/m2 D1 to D5
16136296|NCT01887340|Drug|Cisplatin|20 mg/m2 de D1 to D5
16136297|NCT01887327|Procedure|Phototherapy|Phototherapy starts within 30 minutes before or after injection
16136298|NCT01887327|Drug|Stannsoporfin|Stannsoporfin (3.0 or 4.5 mg/kg) administered by intramuscular (IM) injection (a shot in the muscle)
16136299|NCT01887327|Drug|Placebo|Matching placebo administered by IM injection
16136300|NCT01887314|Dietary Supplement|Standardized Ginger extract|
16136301|NCT01887301|Drug|Sativex|Patients receive four sprays (each 100 uL) of Sativex to the oral mucosa, which contain 10.8 mg THC and 10 mg CBD in total.
16136302|NCT01887288|Drug|Capecitabine|650 mg/m^2 PO b.i.d.
16136303|NCT01887288|Drug|Digoxin|0.25 mg once daily
16136304|NCT01887275|Device|medical ozone therapy with humares|Medical ozone therapy with instrument made in Germany Patients in this group will receive autohemotherapy treatment. First month: ozone concentration: 20µg ~40µg /ml;The second month: 30µg/ml × 100ml oxygen- ozone gas × 100 ml blood;The third month: 20µg/ml × 100ml oxygen- ozone gas× 100 ml blood.
16136305|NCT01887275|Drug|conventional interferon-α|Patients in the conventional interferon-α treatment group received subcutaneouslly injection of 5 million units of conventional interferon-α in three times per week for at least 24 weeks.
16136306|NCT01887262|Device|BCM-guided fluid management|
16136307|NCT01887262|Procedure|Fluid management based on the clinical information alone|
16136308|NCT01887249|Drug|Clarithromycin|
16136309|NCT01887249|Drug|metronidazole|
16136310|NCT01887249|Drug|esomeprazole|
16136311|NCT01887236|Behavioral|Step physical activity program|Participants will take part in a biweekly, 8 week physical activity program that will include step exercises
16136312|NCT01887236|Behavioral|Stability Ball Program|Participants will take part in a biweekly, 8 week physical activity program that will include stability ball exercises
16136313|NCT01887223|Procedure|Transconjunctival needling revision|Surgical revision. A 25 Gauge needle was inserted under the subconjunctival space and perforate the encapsulated bled. The encapsulated bleb was ruptured with sweeping movement up and down, back and forth.
16136314|NCT01887223|Drug|Medical treatment|Hypotensive eye drops are initialized one by one regarding intraocular pressure control. Nonspecific beta blocker and/or prostaglandin, followed by carbonic anhydrase inhibitors and/or selective alpha agonist.
16136315|NCT01887210|Behavioral|IMB Gaming Adherence Intervention|Combination of smart pill bottle cap with mobile gaming application tailored for those living with HIV
16136316|NCT01887210|Behavioral|Enhanced treatment as usual|Smart pill bottle cap and mobile phone but no game
16136317|NCT01887197|Other|Absorptive clearance scan|Subjects inhale a nebulized mixture of the radiopharmaceuticals Indium 111-DTPA and Technetium 99m sulfur colloid.
16136318|NCT01887197|Drug|inhaled hypertonic saline (7%)|nebulized hypertonic saline (7%)
16136319|NCT01887197|Drug|mannitol inhalation powder|mannitol inhalation powder
16136320|NCT01887184|Drug|Dexmedetomidine|Dexmedetomidine 1.5mcg/kg was given intranassaly
16136321|NCT01887171|Drug|Tacrolimus|1000 ml of HTK solution (Custodiol, Dr. Franz Köhler Chemie GmBH) cooled to 2-4˚C containing 20 ng/ml Tacrolimus would be given through intraportal (under gravity pressure of 40 cm H2O) and intraarterial infusion (under pressure of 40-50 mm Hg) followed by intraportal infusion of 200 ml 5% solution of Albumin containing 20 ng/ml Tacrolimus under gravity pressure of 40 cm H2O.
16136322|NCT01887158|Drug|Polyethylene glycol|
16136323|NCT01887158|Drug|Bisacodyl|
16136324|NCT01887145|Procedure|Endoscopic surgery|Surgery dwas done under local anesthesia injected at the portal sites only. Tourniquet was used. Each of the two skin incisions in the endoscopic procedure was 1 cm long. With the endoscope inserted from the distal portal and a hook knife inserted from the proximal portal, the transverse carpal ligament was divided from its distal edge to its proximal edge. Incisions were closed with non-absorbables sutures and a soft dressing was applied. Sutures were removed 10 days postoperatively.
16136330|NCT01887106|Drug|GLPG1205 single ascending doses, oral suspension|Single dose, oral suspension at 10 mg/mL or 50 mg/mL, starting dose of 10mg escalating up to 800mg
16136331|NCT01887106|Drug|Placebo single ascending doses, oral suspension|Single dose, oral suspension matching placebo
16136332|NCT01887106|Drug|GLPG1205, multiple ascending doses, oral suspension|Multiple doses, daily for 14 days, oral suspension at 10 mg/mL or 50 mg/mL, anticipated doses: 100mg to 400mg
16136333|NCT01887106|Drug|Placebo, multiple ascending doses, oral suspension|Multiple doses, daily for 14 days, oral suspension matching placebo
16136334|NCT01887093|Behavioral|walking|Participants in both walking groups were requested to walk at the speed of 2.5 miles/h for 30 min/day or more on at least 5 days/week for a period of 12 weeks.One group was asked to walk in the morning and the other group was asked to walk in the evening.
16136335|NCT01887080|Other|Exercise|"This group had the exercise program, thrice a week for eight weeks.
~The exercise protocol consists of 10 exercises: aerobic and resistance exercises. It was used a moderate intensity (60% of maximum heart rate of stress test with progression until 80%). Subjects were taught to monitor exercise intensity by measuring the manual heart rate, by using the scale of perceived exertion Borg (11-13), and by observation of signs.
~The exercise protocol was done with supervision from a distance, using information technologies (SMS, phone, email ...), and when necessary it was resorted to routine meetings."
16136336|NCT01887080|Device|Microcurrent|"This group had the exercise program after electrolipolysis, thrice a week for eight weeks.
~The electrolipolysis consisted of 30-minute sessions: the first 15 minutes with a frequency of 30 Hz and the final 15 minutes with a frequency of 10 Hz; with a pulse time of 10 ms; and an intensity below the threshold of sensitivity (with a maximum of 750 μA). There were used 4 transcutaneous electrodes in the abdominal region (parallel position).
~Microcurrent was done with supervision from a distance, using information technologies (SMS, phone, email ...), and when necessary it was resorted to routine meetings."
16136337|NCT01887080|Other|Cardiovascular Risk Factors|It was handed flyers on major cardiovascular risk factors: cholesterol, obesity, diabetes, smoking and hypertension.
16136338|NCT01887067|Procedure|Renal denervation therapy|
16136339|NCT01887054|Device|Tower of Hanoi|
16136340|NCT01887054|Other|Placebo group - non use of Tower of Hanoi|
16136341|NCT01887041|Procedure|Stent|Endoscopically inserted biliary tract drainage
16136342|NCT01887041|Procedure|Biliodigestive anastomosis|Biliodigestive anastomosis
16136343|NCT01887028|Device|Fisher and Paykel Humidifier (MR860AEU)|Humidification to 98% relative humidity, and warming to 37 degrees C of laparoscopic insufflate. This will be done for the duration of the operation
16136344|NCT01887015|Device|Nasal high flow cannula (OptiflowTM, MR850 heated humidified, Fisher & Paykel Healthcare, Auckland, New Zealand)|
16136345|NCT01887002|Drug|ONO-2952|ONO-2952 Active tablets, every day for 2 weeks
16136346|NCT01887002|Drug|Placebo comparator|ONO-2952 Matching Placebo every day for 2 weeks
16136347|NCT01886989|Dietary Supplement|Cocoa polyphenols|Cocoa polyphenols (960mg) reconstituted in water
16136348|NCT01886976|Biological|CART-138 cells|
16136349|NCT01886963|Procedure|SPY - Unblinded use of SPY Elite|Surgeon plans tissue advancement flaps with the aid of Spy Elite System imaging
16136350|NCT01886963|Procedure|Control - Blinded use of SPY Elite|Surgeon is blinded to Spy Elite imaging and plans tissue advancement flaps according to clinical judgment alone
16136351|NCT01886937|Drug|Phentermine|After 7 days of phentermine 37.5 mg administration, food intake should be less than after 14 days of placebo.
16136352|NCT01886937|Drug|placebo|Food intake as measured by a laboratory study should be greater after 7 days of placebo administration compared to seven days of phentermine administration.
16136353|NCT01886924|Behavioral|Brief Computer MI for Smoking Cessation|Brief computer MI intervention to motivate tobacco quitline use
16136354|NCT01886924|Behavioral|Nutrition Control|Computer delivered nutrition education control condition
16136355|NCT01886911|Other|Attention Training Intervention Game|
16136356|NCT01886911|Other|Prosocial Training Intervention Game|
16136357|NCT01886911|Other|Control for Attention Intervention|
16136358|NCT01886911|Other|Control for Prosocial Intervention|
16136359|NCT01886898|Other|Infant formula|infant formula
16136360|NCT01886898|Other|Breastfeeding|
16136361|NCT01886885|Behavioral|Mindfulness Based Chronic Pain Management Intervention|Mindfulness-Based Chronic Pain Management (MBCPM) is an intervention developed by Jackie Gardner-Nix, MD for individuals suffering from chronic pain. The focus of MBCPM is to teach clients skills that will facilitate the development of detached observation and reduce the experience of suffering through cognitive re-appraisal. The activities used within MBCPM include mindfulness meditation, gentle stretching/mindful movement, guided imagery, art techniques, psychoeducation, and discussion. There are daily homework assignments of just 5-30 minutes a day in MBCPM. Each class is two hours long with a break in the middle.
16136362|NCT01886872|Drug|Bendamustine Hydrochloride|Given IV
16136363|NCT01886872|Drug|Ibrutinib|Given PO
16136364|NCT01886872|Other|Laboratory Biomarker Analysis|Correlative studies
16136365|NCT01886872|Other|Quality-of-Life Assessment|Ancillary studies
16136366|NCT01886872|Biological|Rituximab|Given IV
16136367|NCT01886859|Drug|Ibrutinib|Given PO
16136368|NCT01886859|Drug|Lenalidomide|Given PO
16136369|NCT01886820|Drug|[18F]NAV4694|
16136370|NCT01886807|Device|TrueView PCD Video Laryngoscope|
16136371|NCT01886794|Drug|Postmenopausal, topical vaginal cream|Topical vaginal estrogen cream is commonly but not universally used to improve the health of vaginal tissue prior to surgery. This study will provide data regarding estrogen effects for post-menopausal women undergoing pelvic organ prolapse.
16136372|NCT01886794|Drug|Placebo Comparator: Postmenopausal, topical placebo cream|Postmenopausal participants randomized to topical vaginal placebo for about one month's use prior to scheduled surgery.
16136373|NCT01886781|Drug|Lactobacillus plantarum 299v|two capsules of 5 X 10 ^9 c.f.u each
16136374|NCT01886781|Drug|Placebo comparator|Micro-crystalline cellulose powder, identical taste, texture and appearance
16136375|NCT01886781|Other|Run in period|Run -in period of one to two weeks. No treatment. Treatment started at baseline following randomization to either L.plantarum 299v or placebo
16136376|NCT01886781|Other|Wash - out period|Wash - out period following treatment phase of eight weeks
16136377|NCT01886768|Device|Double pledget nasal anesthesia (DPNA)|By using a transnasal endoscope as a guide and a biopsy forceps, two gauze strips soaked with decongestant and anesthesia will be delivered to the middle meatus followed by the inferior meatus under real-time transnasal endoscopic guidance.
16136378|NCT01886768|Device|Single pledget nasal anesthesia (SPNA)|Another randomized group of patients will also receive endoscopic-guided gauze pledgetting using a transnasal endoscope as a guide and a biopsy forceps. One gauze strip soaked with decongestant and anesthesia will be delivered to either the middle meatus or inferior meatus determined by anterior rhinoscopy.
16136379|NCT01886755|Dietary Supplement|ORS rehydration solution|
16136380|NCT01886755|Dietary Supplement|placebo|
16136381|NCT01886742|Drug|Standard Dose Group|The standard dose of Cefazolin will be administered intravenously.
16136382|NCT01886742|Drug|Weight Based Group|The weight-based dose group will receive 30 mg/kg cefazolin dose intravenously.
16136383|NCT01886729|Other|transcranial direct current stimulation (tDCS)|
16136384|NCT01886716|Behavioral|Anxiety Attention Training|Anxiety Attention Training will preferentially direct participants' attention away from reminders of anxiety.
16136385|NCT01886716|Behavioral|Alcohol Attention Training|Alcohol Attention Training will preferentially direct participants' attention away from reminders of alcohol.
16136386|NCT01886716|Behavioral|Control Training|Placebo Anxiety Training and Placebo Alcohol Training will not preferentially direct participants' attention away from reminders of anxiety or alcohol.
16136387|NCT01886703|Behavioral|Pedometer Walking Program|All subjects will be prescribed a low-intensity walking program based on their current activity level and an daily assigned step count goal (with the current physical activity recommendations of 30 minutes of moderate-to-vigorous activity per day or 150 minutes per week as the ideal goal). Participants will be provided with face-to-face counseling and written material describing their specific individualized walking program. Participants will also be instructed to maintain their normal activities as much as possible during the intervention period. Participants will be given a pedometer and instructed to wear it at least 5 days per week for the duration of the study.
16136388|NCT01886690|Drug|carboxymethylcellulose sodium based new eye drop formulation|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation in each eye as per protocol for 90 days.
16136389|NCT01886690|Drug|carboxymethylcellulose sodium based eye drops|1 to 2 drops carboxymethylcellulose sodium based (REFRESH PLUS®) eye drops in each eye as per protocol for 90 days.
16136390|NCT01886677|Behavioral|Immediate diet and exercise intervention|Both arms will receive the same intervention: a healthful diet plus exercise intervention to promote a weight loss of up to 2 pounds/week. The only difference is the timing of the delivery of the intervention (immediate vs. delayed).
16136391|NCT01886677|Behavioral|Delayed diet and exercise intervention|Both arms will receive the same intervention: a healthful diet plus exercise intervention to promote a weight loss of up to 2 pounds/week. The only difference is the timing of the delivery of the intervention (immediate vs. delayed).
16136392|NCT01886664|Drug|sevoflurane|
16136393|NCT01886664|Drug|Desflurane|
16136394|NCT01886638|Drug|Abacavir|
16136395|NCT01886625|Procedure|unilateral single-port VATS sympathicotomy|
16136396|NCT01886612|Device|Duo-STIM neuromuscular electrical stimulator|
16136397|NCT01886612|Device|AV Impulse System Model 6000|
16136398|NCT01886599|Drug|Asunaprevir|
16136399|NCT01886586|Behavioral|Problem Solving Therapy|6-12 sessions of Problem Solving Therapy (both members of dyad)
16136400|NCT01886586|Behavioral|Problem Solving Therapy + Exercise|6-12 sessions of Problem Solving Therapy + Exercise (both members of dyad)
16136401|NCT01886586|Other|Enhanced Usual Care|Staff will document and monitor all mental health treatment (e.g., medications that participant may be taking) and psychotherapy (e.g. counseling or social services).
16136402|NCT01886573|Drug|Azacitidine|Given SC
16136403|NCT01886573|Drug|Entinostat|Given PO
16136404|NCT01886573|Other|Laboratory Biomarker Analysis|Correlative studies
16136405|NCT01886573|Other|Pharmacological Study|Correlative studies
16136406|NCT01886573|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16136407|NCT01886560|Drug|Doxycycline|Tablets Doxycycline 50mg bid for 2 weeks,50mg qd for 10 weeks.
16136408|NCT01886560|Drug|Placebo|Tablets placebo one PO per day for 12 weeks
16136409|NCT01886547|Other|Prostate health screening|
16136410|NCT01886534|Other|Standardized Heart Failure Discharge Summary to Primary Care Physicians©|At hospital discharge, in addition to usual care, the Study Nurse will fax an introduction letter and a 1-page comprehensive Standardized Heart Failure Discharge Summary to Primary Care Physicians© integrating Canadian Cardiovascular Society HF guideline recommendations to the patient's family physician.
16136411|NCT01886534|Behavioral|Standardized education sessions|Following baseline data collection, and prior to hospital discharge or within 72 hours of discharge, all patient/caregiver dyads in the intervention group will receive a 45-60-minute standardized education session with the study nurse according to individualized patient learning needs, aimed to ensure similar baseline level of heart failure self-care knowledge. Verbal (teach-back) and written information from the Trial of Education And Compliance in Heart dysfunction (TEACH) RCT will be provided to all patient/caregiver dyads. Information regarding self-care such as dietary restrictions, exercise guidelines, weight and symptom monitoring (shortness of breath, swelling of the ankles) included in the education package will be reviewed. The teaching sessions will occur at 1 week, 2 weeks, 1 month and 2 months post-discharge.
16136412|NCT01886534|Other|Heart Failure Diuretic Decision Support Tool for Patient Self Management©|Each patient/caregiver dyad will be provided a paper-based Heart Failure Diuretic Decision Support Tool for Patient Self Management© at hospital discharge assisting in the titration of their oral furosemide. The purpose of this tool will be to assist the patient/caregiver in keeping track of signs and symptoms of worsening heart failure. The family physician will also be provided an access to similar decision support tool for management of clinical deterioration.
16136413|NCT01886534|Other|Digital talking scale|Prior to hospital discharge, the patient/caregiver dyad will be provided a digital, talking scale to measure their weight in their home setting.
16136491|NCT01886001|Drug|Povidone-Iodine|Umbilical stump care. Povidone-Iodine, USP, Swabstick Singles, applied once a day to cord stump while umbilical line(s) are in place
16138096|NCT01873170|Drug|etonogestrel exposure|
16136414|NCT01886534|Other|Usual care|Patients allocated to the usual care group will receive the hospital-approved heart failure management booklet which meets evidence-based requirements for outpatient heart failure management. Patients will meet with the hospital HF nurse-clinician (standard at this institution) to review heart failure symptoms and signs, diet and exercise recommendations. They will also meet with the ward pharmacist prior to hospital discharge to review medications and side effects. Referral to the HF clinic and any HF initiative will be left to the discretion of the most responsible physician.
16136415|NCT01886521|Procedure|Lumbar drain|
16136416|NCT01886521|Procedure|Ventricular drain|
16136417|NCT01886508|Procedure|Nerve-spring radical hysterectomy|Nerve-spring radical hysterectomy that is reserve some pelvic autonomic nerves during radical hysterectomy. Reserve hypogastric nerve trunk during dissecting cardinal ligament. Reserve pelvic splanchnic nerve trunk during exsecting uterosacral ligament. Reserve bladder nerve of pelvic plexus during dissecting vesicouterine ligament.
16136418|NCT01886508|Procedure|radical hysterectomy|Radical hysterectomy is Piver III hysterectomy and Q-M classification Type C1 hysterectomy.
16136419|NCT01886495|Other|nutrition intervention|
16136420|NCT01886482|Other|nutrition intervention|high protein diet
16136421|NCT01886469|Drug|HLD100-B|d-amphetamine sulfate capsules, 30 mg, CII (25% SR, 30% pH coat, slow release; formulation B)
16136422|NCT01886469|Drug|HLD100-C|d-amphetamine sulfate capsules, 30 mg, CII (20% SR, 20% pH coat, fast release; formulation E) - this intervention may be deemed unnecessary based on results from Intervention 1.
16136423|NCT01886469|Drug|HLD100-E|d-amphetamine sulfate capsules, 30 mg, CII (20% SR, 20% pH coat, medium release; formulation E) - this intervention may be deemed unnecessary based on results from Interventions 1 and 2.
16136424|NCT01886456|Device|Laser trabeculoplasty|
16136425|NCT01886443|Drug|Antithrombin-III|
16136426|NCT01886443|Drug|Infliximab|
16136427|NCT01886443|Drug|Apotransferrin|
16136428|NCT01886443|Drug|Human recombinant erythropoietin|
16136429|NCT01886443|Drug|C1-Inhibitor|
16136430|NCT01886443|Drug|Glutathione|
16136431|NCT01886443|Drug|Alfa-tocopherol|
16136432|NCT01886443|Drug|Melatonin|
16136433|NCT01886443|Drug|Epoprostenol|
16136434|NCT01886430|Other|Functional electrical stimulation|Functional electrical stimulation for 10 days
16136435|NCT01886430|Other|Placebo electrical stimulation|Placebo electrical stimulation for 10 days
16136436|NCT01886404|Drug|Efavirenz|"HIV-infected subjects currently receiving efavirenz (EFV) containing antiretroviral therapy (ART) will be asked to provide plasma samples. In addition to blood samples for determination of EFV concentrations, we will collect whole blood samples for functional Single Nucleotide Polymorphism (SNP) discovery within known candidate genes of interest in drug metabolism and transport.
~Subjects will be at steady state for efavirenz when blood samples are collected. EFV is usually taken during the evening hours. The study consists of 2 blood draws at 12 and 18 hours post EFV dose. At the first blood draw, venous blood will be obtained by venous puncture for plasma concentrations of EFV and pharmacogenetics. At 18 hours post EFV dose , a second blood draw by venous puncture will be obtained for EFV plasma concentrations.
~Demographics and clinical parameters will be collected at the time of the first visit, Neuropsychological tests and questionnaires completed as well."
16136437|NCT01886391|Behavioral|Diaphragmatic Breathing Retraining|Diaphragmatic breathing retraining (DBR) with a slow breathing pattern such that breathe in slowly through the nose for 4 seconds and breathe out slowly through the mouth for 6 seconds and mediated by Self-efficacy for DBR. Patients in this group will receive detailed instructions, in-person, as to how to carry out the DBR intervention at home. They will provide a return demonstration to the research staff about how to do the deep breathing. They will also receive a written script of the DBR intervention. In addition to the script, patients in this group will receive 3 audio CDs (1 for week 1 [5-min DBR], 1 for week 2 [10-min DBR], 1 for weeks 3-8 [15-min DBR]), developed by the PI, to use to practice their deep breathing.
16136438|NCT01886378|Drug|UX007|
16136439|NCT01886365|Device|Space GlucoseControl System, B. Braun, Melsungen, Germany|Computerized algorithmic application of insulin
16136440|NCT01886365|Other|Conventional therapy with a fixed insulin dosing scheme|Routine care
16136441|NCT01886352|Drug|Standard Injection of Levobupivacaine in portal sites.|All port sites will be injected with 0.1ml/kg levobupivacaine at the end of surgery, after trocar removal.
16136442|NCT01886352|Drug|Additional injection of 0,5% levobupivacaine.|Immediately following insufflation 0.15ml/kg levobupivacaine will be injected in the peritoneal cavity via a trocar. At the end of the surgery, this process will be repeated with the same dose at 0.15ml/kg.
16136443|NCT01886352|Drug|Intraperitoneal atomization of levobupivacaine.|"Immediately following insufflation the Optispray® surgical spray device will be inserted into the abdomen and directed towards the diaphragms, dome of inflated abdomen, bowel peritoneum and surgical dissection site and the study drug will be delivered as an atomized spray in the following volumes:
~Each subdiaphragmatic area 0.05 ml/kg
~Dome of abdomen then settling onto bowel 0.05 ml/kg
~Surgical dissection site 0.05 ml/kg
~At the end of the surgery - this process will be repeated with the same doses at 0.15 ml/kg."
16136444|NCT01886339|Other|SNIF test (Sniff Nasal Inspiratory Force)|
16136445|NCT01886326|Other|Consumption of 42 grams of peanuts daily|Consumption of the given 42 grams of peanuts daily without instructions for use (i.e. with/without meals, etc.)
16136446|NCT01886313|Drug|Civamide Nasal Spray|
16136447|NCT01886313|Drug|Placebo|
16136448|NCT01886287|Drug|Octreotide LAR|Octreotide LAR as outlined in Treatment Arm.
16136449|NCT01886274|Device|Transcranial direct current stimulation|tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The cathodal tDCS decrease the excitability, in this study a constant current of 2 mA intensity was applied for 20 min.
16136450|NCT01886248|Drug|Freeze-dried Concentrated Human Antithrombin Ⅲ 500 IU|
16136451|NCT01886235|Procedure|Diagnostic Microscopy|Undergo intravital microscopy
16136452|NCT01886235|Drug|Fluorescein Sodium Injection|Given IV
16136453|NCT01886235|Other|Laboratory Biomarker Analysis|Correlative studies
16136454|NCT01886235|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16136455|NCT01886222|Other|Long-term mild hypothermia|Hypothermia will be induced within 6 hours of injury and maintained at 34-35℃ for 5 days.Then the patients will be passively rewarmed to a temperature of 36 to 37˚C at a rate no greater than 0.5˚C/4 hours.
16136456|NCT01886222|Other|Normothermia|Patients assigned to the normothermia group will be kept at 36-37℃.
16136457|NCT01886209|Drug|Prednisone|
16136458|NCT01886209|Drug|VX-509|
16136459|NCT01886209|Drug|Methylprednisolone|
16136460|NCT01886196|Drug|Non-steroidal anti-inflammatory drug (Ibuprofen)|400mg of ibuprofen administered after exercise training session 3 days per week
16136461|NCT01886196|Other|placebo|placebo designed to mimic experimental drug (ibuprofen)
16136462|NCT01886196|Behavioral|Resistance exercise|3 sets of 8-12 repetitions of resistance exercise (full body with a focus on the distal radius) completed 3 days/week under supervision in the research gym
16136463|NCT01886196|Behavioral|Flexibility training|3 days of full body stretching program (approximately 1 hour) to be performed at participants home unsupervised
16136464|NCT01886183|Other|Virtual Reality Training|The participants of the study will be trained 8 balance games during 14 sessions
16136465|NCT01886183|Other|Physical Therapy|Patients of the control group will be trained with balance exercises.
16136466|NCT01886170|Other|Phase II of the Study: Information regarding Current Diabetes Control|Participants will receive information regarding their current diabetes control in different ways depending on their assigned study arm.
16136467|NCT01886157|Procedure|Corticosteroid injection + Trigger Splint+ Education and Home exercises|Standard corticosteroid injection. Hand based, single digit trigger splint will be applied. Education and instructions about home exercises.
16136468|NCT01886157|Procedure|Corticosteroid injection|Standard trigger finger corticosteroid injection.
16136469|NCT01886144|Device|Knee OA Brace|
16136470|NCT01886131|Other|Synchronised video-polysomnography|"We will record the electrical activity of the STN (local field potentials) during the 2 consecutive nights following the implantation of the electrodes in the STN for DBS. In this period, the deep brain stimulator will not yet be connected to the intracranial electrodes.
~The intracranial EEG signal from the STN will be synchronised with the scalp EEG and other video-polysomnographic parameters.
~The STN recordings during the phasic movements of RBD will be compared to the recordings obtained at the same level during a motor task."
16136471|NCT01886118|Procedure|Endometrial biopsy|A luteal phase endometrial biopsy will be performed in the cycle prior to the patient's In Vitro Fertilization stimulation cycle using a standard Pipelle Endometrial Suction curette in all participants between days ovulation+5 and ovulation+7 of the cycle preceding the stimulation cycle
16136472|NCT01886118|Other|Autologous Endometrial Co-Culture|embryos will be transferred to Endocell co-culture media for Autologous Endometrial Co-Culture between day 2 and day 5
16136473|NCT01886118|Other|Conventional media culture|embryos are cultured in conventional media
16136474|NCT01886105|Drug|Sm-EDTMP|"Subjects receive a tracer infusion of Samarium-153 EDTMP at 1 mCi/kg. 3D dosimetry using SPECT images are obtained post tracer infusion to determine the distribution of dose delivered to the tumor and surrounding normal tissues. Tracer activity will be applied to development of the external beam radiation (EBT) planning. Second treatment infusion of Samarium will then be implemented. Maximum activity administered will be 30 mCi/kg."
16136475|NCT01886105|Other|Autologous Stem Cell Infusion|"Administered 14 days after Treatment infusion of Samarium-153 EDTMP."
16136476|NCT01886105|Radiation|External Beam Radiotherapy|"The radiotherapy portion of the combined plan will be delivered according to the judgement of the treating radiation oncologist. The total dose to be used will be modified based on surrounding tissue tolerances as evidenced by Samarium infusion and SPECT image planning.
~After the treatment infusion, SPECT scans will again be performed to confirm the total dose delivered and subsequently adjust the EBT portion of the treatment plan, as necessary."
16136477|NCT01886092|Device|Active rTMS 1|repetitive transcranial magnetic stimulation (Figured 8-Coil Cool-B65): 1000 stimuli of 1Hz rTMS over the left dorsolateral prefrontal cortex (110% motor threshold) followed by 2000 stimuli of 1 Hz rTMS over the left primary auditory cortex (110% motor threshold), each consisting of 4 days of rTMS treatment. (20 subjects).
16136478|NCT01886092|Device|Active rTMS 2|repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 3000 stimuli of 1 Hz rTMS over the left temporal cortex (110% motor threshold), each consisting of 4 days of rTMS treatment. (20 subjects)
16136479|NCT01886092|Device|Active rTMS 3|repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 3000 stimuli of 1 Hz rTMS over the left dorsolateral prefrontal cortex (110% motor threshold) each consisting of 4 days of rTMS treatment. (20 subjects)
16136480|NCT01886092|Device|sham condition|Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session. (20 subjects)
16136481|NCT01886079|Drug|dexmedetomidine|0.4 mcg/kg/h, IV, The infusion of study drug is started after anesthesia induction and continued until 24 hours after surgery
16136482|NCT01886079|Drug|Saline|0.4 mcg/kg/h, IV
16136483|NCT01886066|Biological|Indocyanine Green (ICG)|ICG (Indocyanine Green) will be used as a fluorescent agent to identify sentinel lymph nodes intraoperatively. One 25 mg vial of ICG will be reconstituted in 10 mL of aqueous solvent (2.5 mg/mL). The solution will be injected at the 3 and 9 o'clock positions of the cervical stroma. 0.5 mL is injected superficially (submucosa) and 0.5 mL is injected deep (~8mm) in the cervical stroma for a total injection volume of 2 mL.
16136484|NCT01886053|Drug|Faropenem（high dose group）|dosage form: Injection dosage:2400 mg frequency: Three times a day
16136485|NCT01886053|Drug|Faropenem（low-dose group)|dosage form: Injection dosage:2400 mg frequency: twice a day
16136486|NCT01886053|Drug|Ertapenem|dosage form: Injection dosage:1000 mg frequency: once a day
16136487|NCT01886027|Behavioral|Emotional Awareness and Expression Training|An emotional processing intervention, which aims to reduce stress by helping patients become aware of, and express emotions related to stressful life experiences, as well as teaching patients how to relate to others differently.
16136488|NCT01886027|Behavioral|Relaxation Training|Teaches patients different relaxation training skills to reduce their distress and discomfort (i.e., progressive muscle relaxation, applied relaxation, or guided imagery.
16136489|NCT01886014|Drug|Oxytocin|
16136490|NCT01886014|Other|placebo|
16136530|NCT01885663|Procedure|Umbilical cord blood therapy|Intravascular umbilical cord blood therapy
16136492|NCT01886001|Drug|Chlorhexidine|Umbilical stump care. Chlorhexidine Gluconate 2% w/v; 70% Isopropyl Alcohol v/v Swabstick Single, applied once a day to cord stump while umbilical line(s) are in place
16136493|NCT01886001|Drug|Pluronic|Umbilical stump care. Pluronic gel - (F68, Polymyxin, Nystatin, Nitrofurantoin)applied once a day to cord stump while umbilical line(s) are in place
16136494|NCT01886001|Other|Control|No product is applied to cord stump while umbilical line(s) are in place. This is the current standard of care at UVA.
16136495|NCT01885988|Drug|Nebivolol|Nebivolol 5, 10 or 20 mg tablet, oral, daily for 3 months. Nebivolol dosage will be titrated per blood pressure results.
16136496|NCT01885988|Drug|Sugar Pill|Sugar pill 5, 10 or 20mg taken by mouth, daily. Sugar pill dosage will be titrated per blood pressure results.
16136497|NCT01885962|Behavioral|iSHIFTup|Internet-delivered program to support behaviors to prevent pressure ulcers and promote healthy skin in adults with spinal cord injury.
16136500|NCT01885936|Drug|Albuterol|Initially 4 mg daily for one week, 4 mg BID per oral daily for the next 5 weeks. If the 4 mg BID per oral is well tolerated, the dose will be increased to 8 mg each morning/4 mg each evening for one week, followed by 8 mg BID per oral for the remainder of the study.
16136501|NCT01885936|Drug|Placebo|Initially one capsule daily for one week, then one capsule BID per oral daily for the next 5 weeks. If the one capsule BID per oral is well tolerated, the dose will be increased to two capsules each morning/one capsule each evening for one week, followed by two capsules BID per oral for the remainder of the study.
16136502|NCT01885923|Device|ITAREPS|Program ITAREPS (Information Technology Aided Relaps Prevention in Schizophrenia)
16136503|NCT01885910|Drug|Doxycycline 100mg|Doxycycline 100mg by mouth once daily
16136504|NCT01885910|Drug|Aczone 5% gel|Aczone 5% gel twice daily
16136505|NCT01885897|Biological|ALT-803|Given weekly IV at assigned dose level, ranging from 1mcg/kg to 30mcg/kg.
16136506|NCT01885884|Behavioral|Embedded Supportive Care|
16136507|NCT01885871|Device|Picosecond QS Nd:YAG Laser|Up to 2 laser treatments delivered 6 weeks apart
16136508|NCT01885858|Behavioral|Indigenous profile|Clinics receive simulated patients (SPs) enacting the indigenous profile, and interpreting a standardized script with a biographical and clinical background. The indigenous SP wears a lliclla (a traditional woven cloth that covers the back and shoulders), long braids, a woven cardigan and loose pants; she uses no make-up and, her patterns of speech are slower and her posture and movement more rigid than the mestizo SP. The script indicates that SPs do not want to have any more children and that her choice of method is the pill.
16136509|NCT01885858|Behavioral|Mestizo profile|Clinics receive simulated patients (SPs) enacting the mestizo profile, and interpreting a standardized script with a biographical and clinical background. The mestizo SP does not wear a lliclla (a traditional woven cloth that covers the back and shoulders) or long braids, but a pony tail or loose hair; she wears make-up and, a vest made of polar fleece, tight pants and culturally salient accessories; her patterns of speech are faster and her posture and movement less rigid than the indigenous SP. The script indicates that SPs do not want to have any more children and that her choice of method is the pill.
16136510|NCT01885845|Device|Excellent BRASSS-V Drape™.|Immediately after delivery and cord clamping, blood measurement will begin. The calibrated delivery drape should be placed under the buttocks of the woman and tied around the woman's waist with the funnel portion hanging down between her legs. Blood loss will be measured for at least one hour or, if bleeding continues after one hour, until active bleeding has stopped.
16136511|NCT01885845|Other|Indirect weight assesment of blood loss|"Just after delivery and cord clamping, a sheet with plastic backing will be placed under the buttocks of the woman. A basin will be placed directly under her on a small shelf on the delivery table. Blood loss will be measured for at least one hour or, if bleeding continues after one hour, until active bleeding has stopped.
~After bleeding has stopped, all gauze pieces and mops will be counted and then placed in the collection basin. The basin will be placed on the scale and weighed. The weight of the blood will be assessed by subtracting the weight of the basin, gauzes and mops from the total weight of the soaked materials assuming that one gram is equivalent to 1 ml."
16136512|NCT01885832|Biological|Autologous adipose tissue stromal vascular fraction|
16136513|NCT01885819|Biological|Autologous stromal vascular fraction cells|
16136514|NCT01885806|Device|Magnetic Stimulator Magstim Rapid 2|All procedures will use the Magnetic Stimulator Magstim Rapid 2. Total of session: 10 rTMS protocol: Freqüency: 10 Hz Intensity: 90% limiar motor Session duration: 16 minutes (20 TMS sequences of 6 second with intervals of 30 seconds between each sequence) Location: Left dorsolateral pre-frontal cortex
16136515|NCT01885806|Device|Sham Magnetic Stimulator|"This intervention will follow the same protocol of the rTMS except that subjects will not receive magnetic stimulation of the brain.
~Total of session: 10"
16136516|NCT01885793|Device|Cuffed endotracheal tube|Intubation with a cuffed endotracheal tube (ETT).
16136517|NCT01885780|Device|Laser-assisted Astigmatic keratotomy|Laser-assisted Astigmatic keratotomy are performed by the VICTUS™ Femtosecond Laser Platform.
16136518|NCT01885741|Device|IPBS|
16136519|NCT01885728|Dietary Supplement|An arginine rich nutritional supplement|Impact is a nutritional supplement formulated with 18 grams of protein per serving and 24 essential nutrients including arginine.
16136520|NCT01885715|Drug|Injection of neostigmine|"At induction, we will inject rocuronium 0.6 mg/kg for rocuronium arms and cisatracurium 0.15 mg/kg for cisatracurium arms.
~During surgical procedure, we will monitor train of four(TOF)using nerve stimulator. When TOF ratio recover to 0.5, normal saline 5 ml will be injected in placebo arms. And neostigmine 10, 20, or 40 ㎍/kg will injected in each arms."
16136521|NCT01885702|Biological|DC vaccination|DC vaccination
16136522|NCT01885689|Drug|clofarabine|Given IV
16136523|NCT01885689|Drug|melphalan|Given IV
16136524|NCT01885689|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo allogeneic hematopoietic stem cell transplant
16136525|NCT01885689|Drug|tacrolimus|Given IV or PO
16136526|NCT01885689|Drug|sirolimus|Given PO
16136527|NCT01885689|Other|Pharmacological Study|Correlative studies
16136528|NCT01885676|Device|PRGF-Endoret|PRGF-Endoret mesotherapy micro injection.
16136529|NCT01885676|Other|Saline Solution|Saline Solution mesotherapy micro injection
16136531|NCT01885650|Other|Airway Clearance Techniques|
16136532|NCT01885637|Other|Transition program|Accelerated transition program from oncological treatment to continuous specialized palliative care and psychological intervention at home for incurable cancer patients
16136533|NCT01885624|Biological|TAB08|monoclonal antibody
16136534|NCT01885611|Other|Multi-Drug Therapy (Novartis Ⓡ)|The MDT is provided by the World Health Organization (WHO) and NovartisⓇ. The MB pack consists of Rifampicin (300mg/tab x 2 tablets), Clofazimine (100mg/tab x 3 tabs and 50mg/tab x 28 tabs), Dapsone (100mg/tab x 29 tabs) and the PB pack consists of Rifampicin (300mg/tab x 2 tablets) and Dapsone (100mg/tab x 29 tabs).
16136535|NCT01885611|Dietary Supplement|Virgin Coconut Oil|cold-processed VCO
16136536|NCT01885598|Drug|Apixaban|
16136537|NCT01885585|Drug|Apixaban|
16136538|NCT01885572|Device|TiLOOP Bra|Titaniferously coated polypropylene mesh
16136539|NCT01885559|Drug|Lisinopril|Lisinopril titrated to 5mg, 10mg, 20mg, 40mg as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.
16136540|NCT01885559|Drug|Telmisartan|Telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.
16136541|NCT01885559|Drug|Placebo|Placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 110-130/80 mm Hg.
16136542|NCT01885546|Device|AgaMatrix Blood Glucose Monitor|
16136543|NCT01885520|Dietary Supplement|fasting condition|eperisone SR tablet 75mg administrated under fasting
16136544|NCT01885520|Dietary Supplement|fed condition|eperisone SR tablet 75mg administrated fed condition
16136545|NCT01885507|Other|Pass recommendations on ventilation factors and extubation|"the use of tidal volume < 7 ml/kg and of a positive expiratory pressure = 6 to 8 cmH20 (centimeter of water)
~extubation as soon as ventilatory weaning is associated with a glasgow coma scale equal or above 10 and cough"
16136546|NCT01885481|Drug|Dexamethasone|epidural steroid injection using dexamethasone
16136547|NCT01885481|Drug|Betamethasone|epidural steroid injection using betamethasone
16136548|NCT01885455|Other|Usual Care|Usual care includes: complete staging work-up (CT/PET scan and possible mediastinoscopy), surgical consultation with a general or cardiothoracic surgeon, cardiac clearance and/or pulmonary function testing (if deemed necessary by the evaluating surgeon), surgical resection (wedge resection, lobectomy, pneumonectomy, or radiosurgery, as indicated by the size and location of the tumor), and adjuvant therapy (radiotherapy and/or chemotherapy, as determined by the intraoperative findings and pathology results).
16136549|NCT01885455|Other|Intervention Arm|The proposed Intervention (EPDPN) will be administered by the PNs at the intervention sites on an outpatient basis. Several defining, fundamental characteristics of the PNs will ensure consistency of the intervention delivery across the various study sites.
16136550|NCT01885442|Device|In-bed leg cycle ergometry|Patients will receive 30 minutes of in-bed leg cycling in addition to routine physiotherapy, 6 days per week, for the duration of their ICU stay (to a maximum of 28 days).
16136551|NCT01885429|Dietary Supplement|Positive Control|Subject consumes 25g of whey protein following unilateral exercise
16136552|NCT01885429|Dietary Supplement|Negative Control|Subject consumes 6.25g of whey protein following unilateral exercise
16136553|NCT01885429|Dietary Supplement|Low Protein Low Leucine Spike|Subject consumes 6.25g of whey protein plus 3g of leucine following unilateral exercise
16136554|NCT01885429|Dietary Supplement|Low Protein High Leucine Spike|Subject consumes 6.25g of whey protein plus 5g of leucine following unilateral exercise
16136555|NCT01885429|Dietary Supplement|Low Protein + High Leucine + BCAA Spike|Subject consumes 6.25g of whey protein plus 5g of leucine plus valine and isoleucine (BCAA) following unilateral exercise
16136556|NCT01885416|Other|consumption of test meal based on dairy products|
16136557|NCT01885416|Other|consumption of high fat test meal without dairy products|
16136558|NCT01885416|Other|consumption of high fat test meal with dairy products|
16136559|NCT01885403|Device|non-invasive respiratory parameter measurements|
16136560|NCT01885390|Device|ROX COUPLER|The COUPLER will be used to create an anastomosis in the iliac region (between the iliac artery and vein).
16136561|NCT01885377|Other|Specific exercise group|A program where exercise load is individually adjusted and the exercises progressed during a 3 month period. The 'pain monitoring model' were used to find the individual resistance. Several exercises are performed eccentrically in order to load more. Initially the exercises were PT-tutored every week and then every other week.
16136562|NCT01885377|Other|Control exercise group|A program with movements to maintain flexibility in the neck and shoulder muscles. Initially PT-tutored every week and then every other week.
16136563|NCT01885364|Drug|Normal saline|intravenous injection with normal saline before injection of propofol
16136564|NCT01885364|Drug|Esmolol|intravenous injection with remifentanil 0.5 mg/kg before injection of propofol
16136565|NCT01885364|Drug|Remifentanil|intravenous injection with remifentanil 0.35 ug/kg before injection of propofol
16136566|NCT01885364|Drug|propofol|intravenous injection after pretreatment
16136567|NCT01885351|Behavioral|MyCRCS+Prefs|"Patients who are identified by the IPHR as study participants will see an attractive link. In the Prefs arm, via question prompt lists, patients will first identify their CRCS preference using previously developed elicitation strategies.
~Tailoring will be used to increase salience of information, motivation, communication, and action plans. We envision the Prefs+ arm in its entirety will be 5-7 minutes, but will depend on Phase I formative work. If the patient remains non-adherent, they will receive an e-mail reminder generated by the IPHR (specific text and frequency determined in Phase I). The Prefs content is identical to the preference portion of the Prefs+Barriers arm, which will allow us to assess the incremental benefit of addressing preferences only and the incremental benefit of addressing preferences and barriers."
16136609|NCT01885013|Drug|Metformin + Myocet + Cyclophosphamide|"Metformin + Myocet + Cyclophosphamide:
~Metformin 1000 mg, 2 times daily per os*. Myocet 60 mg/m2, intravenous infusion, on day 1, every 21 days Chemotherapy will be performed for 8 cycles Cyclophosphamide 600 mg/m2, intravenous infusion, at day 1 every 21 days.
~* During cycle 1, patients will assume only metformin from day 1 to day 13 and will begin chemotherapy from day 14. From day 1 to day 3, patients will assume Metformin 1000 mg once a day. Starting from day 4 patients will assume Metformin 1000 mg 2 times a day."
16136614|NCT01884974|Other|myeloproliferative disease|Echocardiogram, demographic data, St George respiratory questioner
16136568|NCT01885351|Behavioral|MyCRCS+Prefs+Barriers|"Patients who are identified by the IPHR as study participants will see an attractive link. In the Prefs+Barriers arm, via question prompt lists, patients will first identify their CRCS preference using previously developed elicitation strategies, and subsequently based on their test preference determine their top 3-5 test-specific barriers/concerns in real time.
~Tailoring will be used to increase salience of information, motivation, communication, and action plans. We envision the Prefs+Barriers arm in its entirety will be 15-25 minutes, but will depend on Phase I formative work. If the patient remains non-adherent, they will receive an e-mail reminder generated by the IPHR (specific text and frequency determined in Phase I). The Prefs content is identical to the preference portion of the Prefs+Barriers arm, which will allow us to assess the incremental benefit of addressing preferences only and the incremental benefit of addressing preferences and barriers."
16136569|NCT01885338|Drug|N-acetylcysteine (NAC)|
16136570|NCT01885338|Drug|Inactive placebo capsule|
16136571|NCT01885325|Other|Physical Activity Preschool Intervention|Preschools randomized to the multi-component physical activity preschool intervention received four major components:Move IN (physical education and other indoor activity programming), Move OUT (recess and structured outdoor activity), Move to Learn (Physical activity in classroom, academic lessons), and enhancing the social environment to promote PA.The focus in the physical education classes, recess, daily lessons, and reduction of sedentary time will be on providing activities that 3-to 5-year-old children enjoy.
16136572|NCT01885312|Behavioral|Adaptive Tailored Intervention|Adaptive
16136573|NCT01885312|Behavioral|Consequence-based Intervention|Loss Framed
16136574|NCT01885312|Behavioral|Tailored, not adaptive, based Intervention|Baseline tailored not adaptive
16136575|NCT01885312|Other|Assessment only|EMA only
16136576|NCT01885299|Radiation|SRS/SBRT|Intervention varies by condition being treated.
16136577|NCT01885286|Procedure|circumcision with simple circumcision device|Circumcision performed with the device in the operating room using local anesthesia
16136578|NCT01885273|Procedure|Pressurized irrigation method|The pressurized irrigation device is modified from using a special Syringe, connected to Gomco's Vacuum/Pressure Pump Model 309 that generate steady irrigation stream at pressure between 4 to 15 psi that is recommended to be safe and effective pressure for wound cleansing.
16136579|NCT01885273|Procedure|Swabbing wound cleansing method|All patients in control group had wounds cleansed with swabbing technique using forceps and cotton wool (in sterile dressing pack)
16136580|NCT01885260|Drug|ISIS-GCGRRx - Dose Level 1|3 doses on alternate days during the first week and then once weekly for 12 weeks
16136581|NCT01885260|Drug|ISIS-GCGRRx - Dose Level 2|3 doses on alternate days during the first week and then once weekly for 12 weeks
16136582|NCT01885260|Drug|Placebo|3 doses on alternate days during the first week and then once weekly for 12 weeks
16136583|NCT01885234|Other|Aerobic exercise|Pregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of aerobic exercise in a bicycle, 3 times a week
16136584|NCT01885234|Other|Stretch exercise|Pregnant women with Gestational Diabetes and pregnant women with chronic hypertension will perform 50 minutes of stretch exercise, once a week
16136585|NCT01885221|Behavioral|Multimedia Support Intervention|
16136586|NCT01885208|Drug|semaglutide|One dose of 1.0 mg semaglutide administered subcutaneously (s.c., under the skin) once-weekly
16136587|NCT01885208|Drug|exenatide|One dose of 2.0 mg exenatide ER administered subcutaneously (s.c., under the skin) once-weekly
16136588|NCT01885195|Drug|MEK162|MEK162 will be dosed on a flat scale of 45 mg twice daily on a continuous dosing schedule.
16136589|NCT01885182|Drug|Oxycodone/Naloxone|
16136590|NCT01885182|Drug|Oxycodone|
16136591|NCT01885169|Biological|Flumist®|The three cohorts will receive Flumist® and will be swabbed for inflammatory markers and viral shedding.
16136592|NCT01885156|Drug|Naftin 1% Cream|Topically applied once a day
16136593|NCT01885156|Drug|Placebo Cream|Topically applied once a day
16136594|NCT01885143|Radiation|Digital Breast Tomosynthesis|
16136595|NCT01885130|Other|Cetaphil Daily Advance Ultra Hydrating Lotion|0.2ml or 0.2g of Cetaphil on occlusive, hypoallergenic patch applied to skin for 24 hrs 9 times on Monday, Wednesday, and Friday for 3 weeks
16136596|NCT01885117|Biological|TIVf|Trivalent Influenza Virus Vaccine (purified surface antigen, inactivated, egg-derived)
16136597|NCT01885104|Drug|Polyethylene Glycol (PEG 3350)|Oral 17 g dose of PEG 3350 solution concentrate in a volume of approximately 30 mL, once a day, for 14 days.
16136598|NCT01885104|Drug|Placebo|Oral 17 g dose of Placebo solution concentrate in a volume of approximately 30 mL, once a day, for 14 days.
16136599|NCT01885104|Drug|Bisacodyl laxative tablets (rescue medication)|5.0 mg tablets, 1 to 3 tablets in a single daily dose, to be provided for use as rescue medication if participant has not had bowel movement for 72 hours after start of treatment.
16136600|NCT01885091|Other|Kinerase|
16136601|NCT01885078|Drug|Baricitinib|Administered orally
16136602|NCT01885078|Drug|Placebo|Administered orally
16136603|NCT01885065|Other|Gel-based artificial saliva|"Gel-based artificial saliva is an edible non-nutritious gel intended to relieve dry mouth.
~Taking orally 1-2 teaspoon each time, 5 times / day (30-50 ml/ day) for four weeks."
16136604|NCT01885052|Behavioral|QuitTXT Study|Assess the efficacy of a 6-8 week text message program to help young adults quit smoking.
16136605|NCT01885052|Behavioral|Low Contact|
16136606|NCT01885026|Behavioral|eScreen|Access to the eScreen platform offering assessment of alcohol and drug use, with automated feedback on problematic or non-problematic use. Follow-up over time based on user needs.
16136607|NCT01885026|Behavioral|Assessment only of alcohol and drug use.|Assessment of alcohol and drug use at baseline and follow-up.
16136608|NCT01885026|Behavioral|Internet-based treatment for depression or anxiety|Internet-based treatment for primary diagnoses of depression, panic anxiety or social phobia.
16136610|NCT01885013|Drug|Myocet + Cyclophosphamide|"Myocet + Cyclophosphamide:
~Myocet 60 mg/m2, intravenous infusion, on day 1, every 21 days Cyclophosphamide 600 mg/m2, intravenous infusion, on day 1, every 21 days Chemotherapy will be performed for 8 cycles"
16136611|NCT01885000|Drug|Brimonidine tartrate was applied cutaneously once daily for 8 days.|
16136612|NCT01885000|Drug|Brimonidine tartrate vehicle was applied cutaneously once daily for 8 days.|
16136615|NCT01884961|Other|Boost of radiotherapy + high dose IL-2 treatment|Boost of radiotherapy + high dose IL-2 treatment
16136616|NCT01884948|Drug|Omegaven™|
16136617|NCT01884935|Biological|Natalizumab|As specified in the treatment arm
16136618|NCT01884922|Drug|Nilotinib|Tasigna®(nilotinib):: 50 mg, 150 mg and 200 mg capsules. Tasigna® capsules contain lactose monohydrate, crospovidone, poloxamer, colloidal silicon dioxide and magnesium. Orally; the capsules should be swallowed as a whole with water. No food should be consumed for 2 hours before the dose is taken and for at least one hour thereafter. For patients who are unable to swallow capsules, the content of each capsule may be dispersed in one teaspoon of apple sauce or compote or nonfat plain yogurt and should be taken immediately. Not more than one teaspoon of apple sauce / yogourt, and no food other than apple sauce or nonfat plain yogurt must be used.
16136619|NCT01884922|Drug|Vinblastine|"Vinblastine: 3 to 6 mg/m2 once weekly in a 15-minute infusion, on Days 1, 8, 15 and 22 of each cycle.
~Each 28-day cycle is repeated on Day 29/Day 1. No intra-patient doseescalation is permitted. Dose allocation will be centrally defined, based on toxicity observed in patients previously evaluated. Every new patient will be treated at the best current recommended dose, i.e. the dose associated with an estimated level of toxicity that is judged acceptable (20% DLT). At least two patients fully observed with no DLT are requested at a given dose level before dose escalation."
16136620|NCT01884909|Drug|Metoprolol Succinate ER Tablet 200 mg|1 * 200 mg tablet per day
16136621|NCT01884909|Drug|'TOPROL-XL®' ER Tablets 200 mg|1 * 200 mg tablet per day
16136622|NCT01884896|Drug|Metoprolol Succinate ER Tablet 200 mg|1 * 200 mg tablet per day
16136623|NCT01884896|Drug|'TOPROL-XL®' ER Tablets 200 mg|1 * 200 mg tablet per day
16136624|NCT01884883|Device|PROTEOR Internal unicompartmental knee brace|
16136625|NCT01884870|Procedure|Surgical Treatment|Surgical Treatment - open, endoscopic or laparoscopic
16136626|NCT01884857|Drug|Metoprolol Succinate ER Tablets 50 mg|1* 50 mg tablet once a day
16136627|NCT01884857|Drug|'TOPROL-XL®' ER Tablets 50 mg|1 * 50 mg tablet per day
16136628|NCT01884844|Drug|Vitamin D3, Cholecalciferol|
16136629|NCT01884844|Drug|Placebo|
16136630|NCT01884831|Biological|study of the efficacy of skin equivalent comprising living cells and skin biodegradable substrate for the treatment of skin lesions|
16136631|NCT01884818|Other|Manipulation vs. TNS thoracic pain|
16136632|NCT01884805|Device|Monocular Adaptive Optics Visual Simulator (AOVIS-I)|The procedure is guided by the custom made software and its graphical user interface. The interface has been designed to be user-friendly, being very similar to the software usually managed by the clinicians in their daily professional practice. The complete procedure in one patient takes less than 5 minutes and is completely non-invasive. The optical measurements only involve the use of low power infrared laser and the visual testing is as simple for the patients as watching television and making responses.
16136633|NCT01884792|Other|Sitting OGTT|
16136634|NCT01884792|Other|Standing OGTT|
16136635|NCT01884792|Other|Sitting CGM|
16136636|NCT01884792|Other|Standing CGM|
16136637|NCT01884740|Drug|SIACI of Erbitux and Bevacizumab|Subjects will receive a single intra-arterial dose of Cetuximab (200 m/m2) and Bevacizumab (15 mg/kg) via Superselective Intraarterial Cerebral Infusion (SIACI).
16136638|NCT01884727|Dietary Supplement|Salt Water|Subjects to arrive fasted and will spend two 24-h periods inside the metabolic chamber (ASEA or salt water) with a one week interval between visits. Blood will be drawn at 9 am prior to consumption of salt water or breakfast, and at 11 am after consumption of salt water and breakfast. Subjects will receive a second portion of salt water at 10:15 pm just prior to bedtime. The energy content of meals will be identical at each visit.
16136639|NCT01884727|Dietary Supplement|ASEA water|Subjects to arrive fasted and will spend two 24-h periods inside the metabolic chamber (ASEA or salt water) with a one week interval between visits. Blood will be drawn at 9 am prior to consumption of ASEA water or breakfast, and at 11 am after consumption of ASEA water and breakfast. Subjects will receive a second portion of ASEA water at 10:15 pm just prior to bedtime. The energy content of meals will be identical at each visit.
16136640|NCT01884714|Other|High fat/high calorie meal|All subjects are provided a high calorie (~1300kcal) and high fat (~60g fat) breakfast meal.
16136641|NCT01884701|Device|ENABLER-P Catheter System|
16136642|NCT01884688|Drug|ENK Cell Infusion|Day 0(1 dose) ENK Cell Infusion Day 0 to + 12 (13 doses) Aldesleukin (IL2), 3x10 IU
16136643|NCT01884675|Drug|Ambrisentan 5 mg|White, film-coated, immediate-release tablets, containing 5 mg ambrisentan for single dose oral.
16136644|NCT01884675|Drug|Placebo|White, film-coated, ambrisentan-matching placebo tablet for single oral dose
16136645|NCT01884662|Behavioral|Virtual walking|"As in mirror therapy for amputee phantom pain, there is evidence that neuropathic SCI pain responds to images of the person with SCI's legs walking; we achieve this via a virtual reality approach where the subject perceives it is his/her legs walking."
16136646|NCT01884662|Behavioral|Wheeling tape|This control condition mirrors the experimental condition in all respects except it shows still legs in a wheelchair traversing the same path as the virtual walking condition
16136647|NCT01884636|Drug|isavuconazole|oral
16136648|NCT01884636|Drug|methotrexate|oral
16136649|NCT01884623|Drug|Cetuximab|
16136650|NCT01884623|Drug|Methotrexate|
16136651|NCT01884597|Drug|high-dose ranibizumab|20mg ranibizumab vials, 0.05ml injected intravitreally, monthly
16136652|NCT01884597|Drug|ranibizumab|3 mg ranibizumab, liquid, vials, 0.1ml injected intravitreally monthly
16136653|NCT01884584|Drug|Indocyanine green (ICG)|Initial dose of 0.22 mg/kg, which has proven successful in identifying tumor tissue in canine experiments, will be used. The dose will be based on actual body weight. This dose is approximately 40% of the standard human dose for determining cardiac output.
16136654|NCT01884571|Drug|Basiliximab|20 mg, IV (in the vein) on day 1 and 4.
16136655|NCT01884571|Drug|Methylprednisolone|125 mg, IV (in the vein) on day 1.
16136656|NCT01884571|Drug|Prednisone|60 mg PO (by mouth) on days 2-7, 40 mg PO days 8-14, 20 mg PO days 15-21, and 10mg PO days 22-28.
16136657|NCT01884571|Drug|Tacrolimus|1-5 mg PO, twice a day (BID) days 2-180.
16136658|NCT01884571|Drug|Mycophenolate mofetil|500 mg PO, BID days 2-7, 500 mg PO each morning and 1000 mg each night, days 8-14, 1000 mg PO BID days 15-180.
16136659|NCT01884558|Drug|isavuconazole|oral
16136661|NCT01884545|Behavioral|Health coaching|Telephonic health coaching sessions with a trained certified health coach for a period of 6 months (total of 10 biweekly calls).
16136662|NCT01884545|Genetic|Genetic risk counseling|In addition to the SRA subjects will receive genetic risk counseling at the risk counseling visit with a clinic provider. Genetic test results for CHD (rs10757274) and T2D (rs7903146, rs1801282, rs5219) risk variants will be incorporated into the risk profile reviewed with subjects.
16136663|NCT01884545|Behavioral|Standard risk assessment|Standard risk assessment for coronary heart disease (CHD) and type 2 diabetes (T2D). Standard risk factors are reviewed by a provider at a risk counseling visit with the subject.
16136664|NCT01884532|Device|ASR-XL Metal-on-Metal|All patients that are post-operative will have undergone total hip arthroplasty with the ASR-XL Metal-on-Metal device.
16136665|NCT01884519|Biological|Fluarix/Influsplit SSW® (2013-2014 season)|1 dose administered intramuscularly (or deeply subcutaneously) in the deltoid region of the non-dominant arm
16136666|NCT01884506|Dietary Supplement|labeled iron solution|labeled iron as ferrous sulfate (6mg/test meal)
16136667|NCT01884506|Dietary Supplement|labeled iron solution and ascorbic acid|labeled iron as ferrous sulfate plus ascorbic acid (6mg:30mg /test meal)
16136668|NCT01884493|Device|real iTBS|Theta-burst magnetic stimulation (TBS) is a repetitive transcranial magnetic stimulation (rTMS) technique that elicits long-lasting changes in the excitability of human primary motor cortex (M1).
16136669|NCT01884493|Device|sham iTBS|The sham test will be done by transferring the double cone coil 90 degrees anteriorly and putting the lower edge of the coil of the vertex.
16136670|NCT01884467|Drug|Gentamicin|Comparison of Gentamicin versus placebo
16136671|NCT01884467|Drug|Placebo|
16136672|NCT01884454|Behavioral|Sleep deprivation|Volunteers will be submitted to total sleep deprivation (SD) or selective REM sleep deprivation for 48 hours. After SD, these volunteers will be allowed to sleep for 48 hours (period rebound).
16136673|NCT01884441|Drug|Bendamustine|"Schedule:
~Day 2: Bendamustine 90mg/mq Day 3: Bendamustine 90mg/mq for a maximum of 4 cycles"
16136674|NCT01884441|Drug|Gemcitabine|Day 1: Gemcitabine 800mg/mq, Day 4: Gemcitabine 800mg/mq for a maximum of 4 cycles
16136675|NCT01884441|Drug|Vinorelbine|Day 1 Vinorelbine 20mg/mq for a maximum of 4 cycles
16136676|NCT01884428|Drug|panobinostat|Dose excalation oral panobinostat 3 days a week for a maximum of 4 cycles of three weeks duration
16136677|NCT01884428|Drug|Ifosfamide|Ifosfamide 2000 mg/m2 on days 1 to 4 as a 2-hour infusion for a maximum of 4 cycles of three weeks duration
16136678|NCT01884428|Drug|Gemcitabine|Gemcitabine 800 mg/m2 on days 1 and 4 for a maximum of 4 cycles of three weeks duration
16136679|NCT01884428|Drug|Vinorelbine|Vinorelbine 20 mg/m2 on day 1 for a maximum of 4 cycles of three weeks duration
16136680|NCT01884428|Drug|Prednisolone|Prednisolone 100 mg on days 1 to 4 for a maximum of 4 cycles of three weeks duration
16136681|NCT01884415|Biological|HBV vaccine|Patients receive a second cycle of vaccination
16136682|NCT01884415|Biological|HBV vaccine|Patients receive vaccination according to the guidelines.
16136683|NCT01884402|Drug|Peginterferon alfa-2a|Treatment as usual clinical practice
16136684|NCT01884402|Drug|Ribavirin|Treatment as usual clinical practice
16136685|NCT01884389|Other|Patient Navigation|Home-based medical and social support services, as an extension of and collaboration with primary care services provided. Phone calls and visits scheduled based on patient's level of need. Communication with primary care team via navigation plan faxed / emailed as needed. Volunteers will also be matched with intervention patients to provide additional support services by phone / in-person visits.
16136686|NCT01884376|Device|Neuromaix|
16136687|NCT01884363|Other|Once ounce per day of walnuts|
16136688|NCT01884350|Drug|Apixaban|
16136689|NCT01884337|Drug|Apixaban|
16136690|NCT01884324|Other|Early Delivery|"This will be a randomized clinical investigation. The subjects will be allocated into early and late delivery groups using concealed allocation envelopes, which will be created prior to the start of the study using a random allocation sequence. The trial will be conducted in an intent-to-treat fashion."
16136691|NCT01884311|Biological|Subgam|Subgam-VF dose will be given as 1.37 of the established IGIV dose (expressed in mg/kg/week) for 26 weeks (26 infusions) beginning one week after the last IGIV infusion. Dose of Subgam-VF will then be adjusted based on the ratio of the Immunoglobulin G (IgG) average concentration achieved with Subgam-VF compared to IGIV.
16136692|NCT01884298|Drug|remifentanil(Ultiva)|remifentanil (TCI, Ce 3 ng /ml)for intra-operative analgesia
16136693|NCT01884298|Drug|epidural infusing 2% lidocaine|epidural infusing 2% lidocaine 4ml bolus followed by 6-18ml/hr for intra-operative analgesia
16136694|NCT01884285|Drug|Part A: AZD8186 monotherapy|The initial schedule will use intermittent dosing of AZD8186. Dose, frequency and schedule in subsequent cohorts may be modified in response to safety, tolerability, pharmacokinetic and preclinical data.
16136695|NCT01884285|Drug|Part B: AZD8186 monotherapy|Part B will be at a dose(s) and schedule(s) at or below from Part A
16136696|NCT01884285|Drug|Part C1: Abiraterone acetate combination with AZD8186|Dose and schedule finding of AZD8186 added to approved labelled dose of abiraterone acetate (with prednisone).
16136697|NCT01884285|Drug|Part D1: AZD2014 combination with AZD8186|Dose & schedule finding of AZD8186 in combination with AZD2014
16136698|NCT01884285|Drug|Part D2 AZD2014 combination with AZD8186|Combination AZD8186/ AZD2014 dose expansion at dose determined in Part D1
16136699|NCT01884285|Drug|Part C2: Abiraterone acetate combination with AZD8186|Dose expansion of AZD8186 at dose determined in Part C1 added to approved dose of abiraterone acetate (with prednisone)
16136700|NCT01884272|Drug|lesinurad 400 mg|
16136701|NCT01884272|Drug|naproxen 250 mg|
16136702|NCT01884272|Drug|indomethacin 25 mg|
16136703|NCT01884259|Drug|Docetaxel|75 mg/m² on day 1 of 21-days cycle
16136704|NCT01884259|Drug|Cisplatin|75 mg/m² on day 1 of 21-days cycle
16136705|NCT01884259|Drug|5-fluorouracil|750 mg/m² day 1 to 5 during 24 hours of 21-days cycle
16136706|NCT01884259|Biological|Cetuximab Induction|weekly, starting with 400 mg/m² during 120 min.(saturation) then continuing with 250 mg/m²; duration 3 cycles with 21 days
16136707|NCT01884259|Biological|Cetuximab Radioimmunotherapy|weekly, starting with 400 mg/m² during 120 min.(saturation only arm A) then continuing with 250 mg/m²; duration 7 weeks
16136708|NCT01884259|Radiation|Boost irradiation|First 18 irradiations once daily with single dose of 1,8 Gy for 5 days per week. In addition by day 19 a second irradiation boost will be applied for further 12 days(1,5 Gy per day with at least 5 hours interval to 1,8 Gy dose. This results in total clinical target dose of 72 Gy and total subclinical target dose of 54 Gy. Duration of irradiation: 6 weeks
16136709|NCT01884246|Behavioral|Self-care CVD risk reduction|A patient-centered, culturally appropriate lifestyle approach to promoting self-care in high risk patients.
16136710|NCT01884246|Other|Referral to primary care provider for CVD risk management|The study team provides a primary care provider for the patient, makes the referral and sends appropriate CVD risk reduction guidelines to the provider.
16136711|NCT01884233|Behavioral|Standard Care|Standard care will include usual treatment for HIV and a pamphlet that will be provided to the participants with information about ART adherence and relapse prevention.
16136712|NCT01884233|Behavioral|Text Messaging CBT (TXT-CBT)|Those assigned to TXT-CBT will be given a treatment manual (developed in Phase I) containing descriptions of core therapeutic content/topics for each week. HIV-infected participants will have initial meeting with a CBT clinician to review the core CBT concepts for promoting ART adherence. The 3 most applicable medication adherence skills will be identified for emphasis in tailored messages. A research coordinator will meet with the participants weekly at data collection visits throughout the intervention phase to answer any technical questions and ensure that the intervention program is working properly.
16136713|NCT01884220|Other|There are no interventions in this study.|
16136714|NCT01884207|Other|MRI|
16136715|NCT01884168|Biological|Dc-CIK immunotherapy|The patients with malignant cavity effusion are treated with dendritic cells (DC) plus cytokine induced killer cells (CIK) locally.
16136716|NCT01884155|Procedure|Allogeneic umbilical cord blood therapy|
16136717|NCT01884142|Other|Aerobic Exercise Training|
16136718|NCT01884116|Drug|NSAID patch|
16136719|NCT01884116|Drug|NSAID patch + transcutaneous electric nerve stimulation|The patients of the experimental groups will be divided in to three groups according to what they are administered: NSAID patch plus transcutaneous electric nerve stimulation, NSAID patch plus heating pad, and NSAID patch plus topical capsaicin. All the groups will be observed for two weeks.
16136720|NCT01884116|Drug|NSAID patch + heating pad|The patients of the experimental groups will be divided in to three groups according to what they are administered: NSAID patch plus transcutaneous electric nerve stimulation, NSAID patch plus heating pad, and NSAID patch plus topical capsaicin. All the groups will be observed for two weeks.
16136721|NCT01884116|Drug|NSAID patch + topical capsaicin|The patients of the experimental groups will be divided in to three groups according to what they are administered: NSAID patch plus transcutaneous electric nerve stimulation, NSAID patch plus heating pad, and NSAID patch plus topical capsaicin. All the groups will be observed for two weeks.
16136722|NCT01884090|Behavioral|Youth Empowerment Solutions (YES)|Participants receiving the The 16-week, 30-session YES curriculum YES as a part of the 21st Century after-school program at middle schools that have high economic and academic needs. 21st Century is a U.S. Department of Education program which provides academic enrichment opportunities during non-school hours and during the summer for children who attend low-performing schools in areas with high poverty (U.S. Department of Education, 2009).
16136723|NCT01884077|Device|Reverse Shoulder Arthroplasty|REVERSE In a Reverse Total shoulder the ball is located on the shoulder blade (glenoid) and the socket is located on the arm bone (humerus), exactly the opposite of the situation in a conventional total shoulder. The ball (glenosphere) is screwed to the bone of the shoulder blade. The cup (humeral sock¬et) is fixed to a stem that is cemented down the inside of the arm bone (humerus).
16136724|NCT01884077|Device|Total Shoulder Arthroplasty|TOTAL In a conventional Total shoulder, the arthritic surface of the ball is replaced with a metal ball with a stem that is press fit in the inside of the arm bone (humerus) and the socket is resurfaced with a component.
16136725|NCT01884064|Device|rTMS|rTMS
16136726|NCT01884064|Device|Sham rTMS|Sham rTMS
16136727|NCT01884038|Drug|treprostinil sodium|"A single dose strength of treprostinil sodium (1.0 mg/mL) and matching placebo will be provided in 20-mL multi-dose vials.
~The study drug will be started after induction of anesthesia and increased incrementally to a target dose of 10 ng/kg/min during surgery and 48 hours post-operative"
16136728|NCT01884038|Drug|Placebo|
16136729|NCT01884025|Behavioral|Get Moving and Get Well|Walking Class
16136730|NCT01884025|Behavioral|Health and Humor Class|Class about the role of humor in health
16136731|NCT01884012|Procedure|long term oxygen therapy|
16136732|NCT01883999|Device|GORE® EXCLUDER® Iliac Branch Endoprosthesis|
16136733|NCT01883986|Behavioral|Palliative Care|Care delivered by a nurse including symptom assessment and management, patient education on lung cancer and treatment options , discussion and communication about preferences for care, psychosocial assessment including referrals to ancillary services such as social services and spiritual care as requested by the patient.
16136734|NCT01883947|Procedure|Touch massage|Touch massage is a gentle massage with strokes on hands, arms, feet and legs with at pressure of 2.5 N which is more gentle than Swedish massage but harder than strokes performed with a brush. The speed of the strokes is about 1-5 cm/sec. During the massage, the subjects will lie on a bed. Intervention group will receive touch massage on hands and feet and the intervention will start one week after the onset of stroke and last for 30 minutes each time, five days a week for two weeks
16136735|NCT01883947|Other|non-TENS|Subjects in the control group will have sham treatment which is a non-active transcutaneous electrical nerve stimulation (non-TENS), while they lie in bed with electrodes attached to the skin of the affected arm. The device will be manipulated in a way so that no electrical impulses will reach the electrodes. During treatment, the masseur will remain in the room without initiating any conversation.
16136736|NCT01883934|Other|Enhanced clinic-based support/counseling|Additional enhanced support services and educational services provided by embryologists, nurses and physicians in the Frozen Embryo Donation Service will be offered.
16136737|NCT01883934|Other|Control|
16136738|NCT01883921|Other|Immunoglobulin Therapy|
16136780|NCT01883596|Drug|0.12% chlorhexidine solution|Bexident® (0.12% chlorhexidine solution)
16136781|NCT01883596|Drug|Placebo|7.4% alcohol, glycerine, normal saline solution, applied topically, every 8 hrs.
16137534|NCT01877642|Drug|Inhaled Placebo|Inhaler with no drug in it to mimic the ADASUVE inhaler
16136739|NCT01883908|Device|Acupuncture with Seirin® needles|Participants will be randomized to receive either usual medical care or acupuncture treatment plus usual medical care once a week for 8 weeks coinciding with their chemoradiation treatments. The length of the study will be 16 weeks: 8 weeks of treatment and two follow up visits at 4 weeks and 8 weeks after radiation (weeks 12 and 16).
16136740|NCT01883908|Other|Usual medical care|usual medical care such as viscous Lidocaine for relief of pain
16136741|NCT01883895|Device|Forgionei-Barber pressure-pain stimulator|Pain testing will be conducted using a Forgioni-Barber pressure-pain stimulator to deliver 3000-gm force to the middle digit of the non-dominant middle finger for up to 120 seconds. During stimulation, subjects will press a button attached to a timer when the pressure stimulus first becomes painful (pain threshold) and will also rate their perceived pain intensity using a 0-100 numeric pain rating scale at 20 second intervals during the 2 minute exposure to the pressure stimulus. This validated protocol has been used in previous research by investigators in this study. This will be used for both exercise sessions and the control session. Forgionei-Barber pressure-pain stimulator will be used.
16136742|NCT01883895|Other|Concentric Exercise|Concentric testing will utilize a dumbbell with elbow flexion exercise. Subjects will perform 5 sets of 20 reps at 30% MVC. Pain testing will be conducted using a Forgionei-Barber pressure-pain stimulator immediately before and after the exercise.
16136743|NCT01883895|Other|isometric exercise|When undergoing isometric exercise, subjects will perform 5 sets of sustained muscle contraction for 65 seconds using a hand-grip dynamometer. Pain testing will be conducted using a Forgionei-Barber pressure-pain stimulator immediately before and after the exercise.
16136744|NCT01883882|Behavioral|opioid taper support|Weekly visits with physician's assistant (supervised by pain physician/psychiatrist and pain psychologist) who provides pharmacological and psychological support for opioid taper at 10% per week
16136745|NCT01883869|Drug|ticagrelor|
16136746|NCT01883869|Drug|placebo|placebo
16136747|NCT01883856|Device|Silicone plate Ahmed Glaucoma Valve (Model FP7)|This intervention is conducted as a surgical intervention.
16136748|NCT01883856|Device|Porous Plate Ahmed Glaucoma Valve (Model M4)|This intervention is conducted as a surgical intervention.
16136749|NCT01883843|Device|sham tDCS + TOCT|Every day will be given a continuous low-intensity stimulation of 0.5mA (for a current density of 60μA/cm2) only for 10 seconds at the beginning and at the end of the stimulation for 10 consecutive days after any rehabilitative treatment. The mounting of electrodes for sham stimulation is the same used for the experimental group.
16136750|NCT01883843|Device|real tDCS + TOCT|Every day will be given continuous stimulation duration of 15 minutes with intensity of 0.5 mA (for a current density of 60μA/cm2), generated by a constant current stimulator rechargeable batteries for 10 consecutive days after any rehabilitation treatment in the gym. Two sponge electrodes are placed, soaked in saline solution, fixed by an elastic band, the anode consists of an electrode oblong 8cm2 positioned at M1 area on the lower limb affection (following the medial sagittal axis, with the center of the electrode positioned at one centimeter laterally to the vertex) while the cathode (48cm2) is placed in the contralateral supraorbitale area as reference electrode. The current reaches 0.5mA and decreases with a ramp of 10 seconds.
16136751|NCT01883830|Device|gaming therapy (Xbox)|
16136752|NCT01883830|Device|Dynamic balance platform (Biodex)|
16136753|NCT01883817|Drug|DHA Omega-3|Patients will receive a fixed dose of DHA (1,200 mg/day, 600 mg twice daily) or placebo (corn/soy oil) over 10 weeks
16136754|NCT01883817|Drug|Placebo|corn/soy oil capsule with similar color, taste, and shape as experimental drug (DHA)
16136755|NCT01883804|Drug|Methyldopa|6 weeks of Methyldopa administration; where the dose will be increased according to safety of efficacy.
16136756|NCT01883791|Behavioral|SBIRT|See above Arm description.
16136757|NCT01883791|Behavioral|Health Education|See Arm Description.
16136758|NCT01883765|Behavioral|Neurofeedback active|
16136759|NCT01883765|Behavioral|Neurofeedback sham|
16136760|NCT01883765|Behavioral|Metacognitive Training|
16136761|NCT01883752|Procedure|Goal-directed Therapy group|Fluid administration is based on the respiratory variation in the pulse oximeter waveform
16136762|NCT01883739|Other|Parental Presence at Handover Rounds|
16136763|NCT01883726|Device|Grayson's presurgical nasoalveolar molding|Grayson NAM
16136764|NCT01883726|Device|Figueroa's presurgical nasoalveolar molding|Figueroa NAM
16136765|NCT01883713|Device|Brain Oximetry|Non invasive brain oximeter will be applied on the patient's forehead to monitor the brain oxygen saturation throughout the surgery.
16136766|NCT01883700|Other|Boiled Pasta|
16136767|NCT01883700|Other|Boiled Chickpeas with Oil|
16136768|NCT01883700|Other|Instant Mashed Potatoes|
16136769|NCT01883700|Other|Instant Mashed Potatoes with Egg Whites|
16136770|NCT01883687|Procedure|Septoplasty|
16136771|NCT01883674|Other|Resistance training|All group will exercise 3x/week. Each session of resistance training will last 60min. and will target main muscular groups.
16136772|NCT01883661|Biological|BMMNC|Bone Marrow derived Mono Nuclear Stem Cell (MNCs) by intravenously route total 3 doses in one month period .
16136773|NCT01883648|Drug|Coconut Oil Beverage|There are 2 treatment arms: Fuel for Thought™ and placebo, with a treatment allocation of 1:1. After 3 months of treatment in one group, subjects will have a 3-5 day wash-out period before receiving the alternate (opposite) treatment for 3 months.
16136774|NCT01883648|Other|Placebo Beverage|There are 2 treatment arms: Fuel for Thought™ and placebo, with a treatment allocation of 1:1. After 3 months of treatment in one group, subjects will have a 3-5 day wash-out period before receiving the alternate (opposite) treatment for 3 months.
16136775|NCT01883635|Behavioral|Survivor-only progressive walking and resistance exercise|Daily, home-based, tailored exercise program delivered over the course of 6 weeks to the survivor only
16136776|NCT01883635|Behavioral|Dyadic progressive walking and resistance exercise|Daily, home-based, tailored exercise program delivered over the course of 6 weeks to the survivor and caregiver as a dyad
16136777|NCT01883609|Biological|RTS,S/AS01B|Each RTS,S/AS01B dose will be given intramuscularly, and will contain 50mcg of RTS,S and standard adult dose of AS01
16136778|NCT01883609|Biological|ChAd63 ME-TRAP|ChAd63 ME-TRAP will be given intramuscularly at a dose of 5 x 1010 vp
16136779|NCT01883609|Biological|MVA ME-TRAP|MVA ME-TRAP will be given intramuscularly at a dose of 2 x 108 pfu
16138097|NCT01873170|Device|IUD insertion|
16136782|NCT01883583|Device|Contrast-enhanced Ultrasound And Sonoelastography|Before ultrasound guided biopsy of transplanted kidney, we will perform conventional, Sonoelastography and real-time contrast-enhanced ultrasound using Sonovue for acquisition of parameters and data, respectively.
16136783|NCT01883570|Other|training in visual search strategy|
16136784|NCT01883570|Other|access to a library of chest x-rays without search strategy|
16136785|NCT01883544|Drug|ALXN1007|
16136786|NCT01883531|Drug|Inhaled Mannitol|Active treatment is inhaled mannitol with a particle size of 3-4 microns
16136787|NCT01883531|Drug|Inhaled Placebo|The PLacebo is non respirable mannitol due to the big size particle
16136788|NCT01883518|Biological|Autologous dendritic cell vaccine|Autologous dendritic cell vaccine loaded with allogeneic tumor lysate expression of cancer testis antigens
16136789|NCT01883505|Drug|Levodopa and carbidopa|Subcutaneous continuous administration
16136790|NCT01883505|Drug|Placebo|Subcutaneous continuous administration
16136791|NCT01883492|Device|Femoral Stem|JMDN classification/Class III device
16136792|NCT01883492|Device|Acetabular Cup|JMDN classification: Class III device
16136793|NCT01883492|Device|Acetabular Liner|JMDN classification: Class III device
16136794|NCT01883479|Behavioral|Exercise|Telephone-based intervention designed to increase exercise among postpartum women.
16136795|NCT01883479|Behavioral|Wellness/Support|Telephone-based intervention designed to provide support to postpartum women.
16136796|NCT01883466|Other|Forearm venous occlusion plethysmography study|Measurement of forearm blood flow during unilateral intrabrachial infusion of four vasodilator drugs in incremental doses separated with 20-min washout periods. Bradykinin (endothelial-dependent vasodilator that releases t-PA) was infused at 100, 300 and 1000 pmol/min; acetylcholine (endothelial independent vasodilator that does not release t-PA) was infused at 5, 10 and 20 mcg/min; sodium nitroprusside (endothelial independent vasodilator that does not release t-PA) was infused at 2, 4 and 8 mcg/min and verapamil (endothelial independent and NO independent vasodilator that does not release t-PA) was infused at 10, 30 and 100 mcg/min. Bradykinin, acetylcholine and sodium nitroprusside were given in random order and verapamil was administered last due to its long acting effects.
16136797|NCT01883453|Device|Glucose oxidase+5%glucose|A hydrogen peroxide producing enzyme
16136798|NCT01883453|Device|Saline+5%glucose|Isotonic saline + 5% glucose in a bag-on-valve nasal spray device
16136799|NCT01883440|Drug|Glucose oxidase + glucose|Isotone saline + 200U/ml of glucose oxidase + 5% of glucose in a bag on valve nasal spray device
16136800|NCT01883440|Drug|Saline+glucose|Placebo arm
16136801|NCT01883427|Drug|Placebo|placebo containing saline+glucose
16136802|NCT01883427|Drug|Glucose oxidase|a hydrogen peroxide producing enzyme that creates an acidous environment to which rhinoviruses are sensitive.
16136803|NCT01883414|Device|Ultherapy™|All subjects will receive an Ultherapy™ treatment at triple depth using the 4-4.5mm, 7- 3.0mm, 10-1.5mm transducers on one half of the scar and no treatment on the other half of the scar. Treatments will be provided to the defined scar area, treating with a density of lines that is equivalent to 30 lines per transducer per 2.5cm in scar length for a total of 90 lines in a 2.5cm X 2.5cm square area.
16136804|NCT01883401|Dietary Supplement|Freeze-dried strawberries|25g or 50g freeze-dried strawberries reconstituted in water
16136805|NCT01883401|Dietary Supplement|Dietary fiber|4g or 8g dietary fiber blended in water
16136806|NCT01883375|Behavioral|Dignity Talk|Patient and family member participants will be given the Dignity Talk framework questions and asked to use them in conversation with each other. Research nurse will return at day 4-6 to confirm both participants have covered all items they wish to discuss. 4-6 months after the death of patient, family members will be contacted in order to collect data pertaining to their bereavement experiences and distress. Will also be asked to complete evaluative feedback on Dignity Talk.
16136807|NCT01883375|Behavioral|The Dignity Talk Communication Topics|There have not been any non-completers - this arm not being used currently
16136808|NCT01883362|Drug|Midostaurin|Midostaurin was supplied in 25mg soft gelatin capsule taken orally twice a day for 28 days of each cycle. Patients will be treated for 12 cycles.
16136809|NCT01883362|Other|Standard of Care|Standard of Care was not defined per protocol. The investigator prescribed based on the commonly used medications given in the post SCT setting.
16136810|NCT01883349|Procedure|Kidney Transplant|Kidney Transplant Surgery
16136811|NCT01883323|Drug|Cyclophosphamide|i.v., 60mg/kg per day for 2 days
16136812|NCT01883323|Drug|Fludarabine|i.v., 25mg/m2 per day for 5 days
16136813|NCT01883323|Biological|Tumor-Infiltrating Lymphocytes|i.v., 1x10^10 - 1.6x10^11 cells
16136814|NCT01883323|Biological|Low-Dose Interleukin|i.v., 125,000 IU/kg subcut per day, for 2 weeks (2 days rest between each week)
16136815|NCT01883310|Device|sham tDCS + TOCT|Anodal transcranial direct current stimulation will be delivered through 2 sponge electrodes (surface area: 25 cm2) soaked in a saline solution. For the cerebellar transcranial direct current stimulation, the anodal electrode will be centered on the right cerebellar cortex, 3 cm lateral to the inion, and the cathodal electrode will be positioned on the right buccinator muscle. Anodal stimulation intensity will be set at 2 mili Ampere and delivered using a rechargeable batteries direct current stimulator.The sham transcranial direct current stimulation group will consist of anodal transcranial direct current stimulation applied for a total duration of 30 s over the right cerebellar position.
16136816|NCT01883310|Device|real tDCS +TOCT|Anodal transcranial direct current stimulation will be delivered through 2 sponge electrodes (surface area: 25 cm2) soaked in a saline solution. For the cerebellar transcranial direct current stimulation, the anodal electrode will be centered on the right cerebellar cortex, 3 cm lateral to the inion, and the cathodal electrode will be positioned on the right buccinator muscle. Anodal stimulation intensity will be set at 2 mili Ampere and delivered using a rechargeable batteries direct current stimulator.The real transcranial direct current stimulation group will consist of anodal transcranial direct current stimulation applied for a total duration of 15 minutes over the right cerebellar position.
16136817|NCT01883297|Biological|Re-stimulated tumor-infiltrating lymphocytes (TILs)|Intravenous infusions: Dose level 1 (3 patients): 3x10^7 TILs (with maximum 3x10^6 autologous dendritic cells); Dose level 2 (3 patients): 1x10^8 TILs (with maximum 1x10^7 autologous dendritic cells); Dose level 3 (3 patients): 3x10^8 TILs (with maximum 3x10^8 autologous dendritic cells)
16138098|NCT01873170|Device|subdermal contraceptive implant insertion|
16136818|NCT01883297|Biological|Interleukin-2|Subcutaneous injections of IL-2 x 4 days during the first week and x 5 days the second week with 2 days of rest in between each week of dosing
16136819|NCT01883297|Drug|Cyclophosphamide|Intravenous infusion: 30 mg/kg/day for 2 days (Day -3 and -2 prior to infusion of TILs)
16136820|NCT01883284|Other|Tests in vitro after sampling nasal cells of CF patients or controls|Nasal cells of CF patients or controls were collected by scratching of intermediate turbinate and cultured in vitro. Epigenetic modifiers treatment was applied to these ex vivo nasal epithelia. Then, mRNA, protein and secretions were quantified.
16136821|NCT01883271|Other|High intensity aerobic interval training|Supervised aerobic interval training will be performed on bicycles 4 times per week for 8 weeks. Each training session will last 40 minutes and will consist of 10-minute warm up at 70% of maximal heart rate (HRmax), four 4-minute intervals at 90% of HRmax with 3-min active recovery at 70% of HRmax and 5-minute cool down at 70% of HRmax.
16136822|NCT01883271|Other|Continuous moderate intensity exercise|Supervised exercise training will be performed on bicycles 4 times per week for 8 weeks. Each training session will last 47 minutes and will consist of continuous moderate intensity cycling at 70% of HRmax.
16136823|NCT01883258|Other|High intensity aerobic interval training|Supervised aerobic interval training will be performed on bicycles 4 times per week for 8 weeks. Each training session will last 40 minutes and will consist of 10-minute warm up at 70% of maximal heart rate (HRmax), four 4-minute intervals at 90% of HRmax with 3-min active recovery at 70% of HRmax and 5-minute cool down at 70% of HRmax.
16136824|NCT01883258|Other|Continuous moderate intensity exercise|Supervised exercise training will be performed on bicycles 4 times per week for 8 weeks. Each training session will last 47 minutes and will consist of continuous moderate intensity cycling at 70% of HRmax.
16136825|NCT01883245|Device|real tDCS|2 milliampere real direct current stimulation for 20 minutes daily for 5 days.
16136826|NCT01883245|Device|sham tDCS|2 milliampere sham direct current stimulation for 20 minutes daily for 5 days.
16136827|NCT01883232|Device|Onset Mixing Pen by Onpharma|Sodium Bicarbonate 8.4%
16136828|NCT01883232|Device|2% lidocaine with 1:100,000 epinephrine|2% lidocaine with 1:100,000 epinephrine administered with a syringe prior to the procedure
16136829|NCT01883219|Drug|TKIs|Imatinib was given at a dose of 400mg/d or 600mg/d, dasatinib at a dose of 100mg/d or 140mg/d, and nilotinib at a dose of 400mg twice daily. If the patients had T315I mutations, ponatinib will be given. If the BCR/ABL levels increased or did not decrease after one month's use of TKI, donor lymphocyte infusion will be given and the TKI drugs will be modulated. If the patients experienced hematologic relapse, they will withdraw from the study.
16136830|NCT01883193|Dietary Supplement|Comprehensive Maternal Nutrition Intervention|The nutrition intervention will be delivered before conception or at 12 weeks gestation and continued through delivery and compared with a control group. The supplement to be used is a multi-micronutrient (MMN) fortified lipid-based supplement composed of dried skimmed milk, soybean and peanut extract, sugar, maltodextrin stabilizers, and emulsifiers.
16136831|NCT01883180|Drug|ATG|ATG will be intravenously infused via a central venous catheter in 3 or 4 days, from day -4 or -3 until day -1. The other conditioning drugs administered before transplantation include cytosine arabinoside (Ara-C), busulfan (Bu),cyclophosphamide (Cy), Semustine(Me-CCNU), and ATG. All transplant recipients will receive cyclosporine A (CsA), mycophenolate mofetil(MMF), and short-term methotrexate for aGVHD prevention.
16136832|NCT01883167|Drug|RDEA3170 10 mg|RDEA3170 10 mg once daily (qd)
16136833|NCT01883167|Drug|Febuxostat 40 mg|Febuxostat 40 mg qd
16136834|NCT01883167|Drug|placebo|placebo qd
16136835|NCT01883141|Procedure|Electrophysiological Study|Subjects will receive pacing from one right ventricular lead and one left ventricular catheter/lead with multiple LV pacing spots
16136836|NCT01883128|Device|Whole Body MRI|Full parametric MRI using T1W, T2W, Diffusion-weighted and dynamic-contrast-enhanced images at 3Tesla
16136837|NCT01883128|Procedure|Focal Salvage Therapy|Cryotherapy and HIFU will be used to targeted the areas of tumor only with a margin of normal tissue.
16136838|NCT01883128|Procedure|MRI Targeted biopsies|Image registration will be used to target biopsies followed by full mapping biopsies of the prostate. All biopsies will be carried out transperineally
16136839|NCT01883102|Drug|Capsaicin 0.1%|Cream will be cleansed from sites A and B with soap and water each morning before reapplying.
16136840|NCT01883102|Drug|Placebo|Cream will be cleansed from sites A and B with soap and water each morning before reapplying.
16136841|NCT01883089|Behavioral|Motivational Enhancement Therapy|
16136842|NCT01883076|Biological|autologous cell-based delivery|"autologous cells (derived from self)"
16136843|NCT01883063|Device|Surgical Treatment|Patients will be treated for distal radius fractures surgically with a WRx™ Intramedullary Nail
16136844|NCT01883063|Device|Non surgical Treatment (Cast or splint)|Patients will be treated for distal radius fractures non surgically with a cast or splint
16136845|NCT01883050|Device|Self Monitoring Software Application|Computer Software application to track health progress after interventional surgery
16136846|NCT01883037|Other|Blood glucose results|The glucose value from the HemoCue Glucose 201 RT will be compared with the Trust Laboratory value.
16136847|NCT01883024|Other|A decision support software|
16136848|NCT01883024|Other|Insulin Pump|
16136849|NCT01883024|Other|Continuous glucose monitoring|
16136850|NCT01883011|Drug|Piracetam|
16136851|NCT01883011|Other|Placebo|
16136852|NCT01882998|Behavioral|Extended repeat HIV testing and enhanced counseling|Pregnant/breastfeeding women in the intervention arm and their male partners if present will receive extended repeat HIV testing and enhanced counseling around the time of labor and delivery and throughout the breastfeeding period.
16136853|NCT01882985|Drug|Docetaxel|Given IV
16136854|NCT01882985|Dietary Supplement|Lycopene|Given PO
16136855|NCT01882972|Behavioral|Exercise|
16136856|NCT01882972|Behavioral|Meditation|
16136857|NCT01882959|Other|Radiofrequncy Denervation|
16136858|NCT01882946|Biological|DCVax-Direct|Autologous, activated dendritic cells for intratumoral injection
16136885|NCT01882764|Drug|Placebo|Remitters and responders from HMPL-004 Induction study and patients complete the 8-week Open Label Induction Phase will be given Placebo orally three times per day with total daily dose of 1800 mg for 52 weeks.
16136859|NCT01882933|Drug|HIPEC (Hyperthermic Intraperitoneal Chemoperfusion) with oxaliplatin|After the D2 resection is complete HIPEC can start. A roller pump forces the chemotherapy solution (oxaliplatin 250 mg/m² with 2 Liters of G5%/m²) into the abdomen through the inflow catheter and pulls it out through the drains. A heat exchanger keeps the intraperitoneal fluid at 42°-43°C.
16136860|NCT01882933|Procedure|Curative gastrectomy|All the patients will undergo a D1-D2 gastrectomy carried out according to Japanese guidelines and to the European recommendations for the preservation of spleen and pancreas
16136861|NCT01882920|Drug|Goal Directed Intravenous Restrictive Fluid Therapy|Basal infusion of crystalloids (normal saline,Ringer's lactate,Ringer's solution) at 4 ml/kg/h and boluses of colloids (HES 130/0.4 ) for values of cardiac index (CI) <2.5 l/min/m2, stroke volume index (SVI) < 35 SVI ml/m2 and stroke volume variation (SVV)> 15%. In the case of CI <2.5 l/min/m2 and SVI <35 ml/m2 with SVV < 15%, an infusion with dopamine was initiated.
16136862|NCT01882920|Drug|Conventional Intravenous Fluid therapy|Basal infusion of crystalloid (normal saline,Ringer's lactate,Ringer's solution)variable from 4 to 12 ml/kg/hour.
16136863|NCT01882907|Drug|vildagliptin|vildagliptin 50mg bid for 16 weeks
16136864|NCT01882907|Drug|Pioglitazone|Pioglitazone 15mg bid for 16 weeks
16136865|NCT01882894|Device|Custom PFO|PFO made out of thermoplastic material molded to the patient's foot
16136866|NCT01882894|Other|Faux orthosis|Foam cut out
16136867|NCT01882881|Other|Healthy American Control Diet|The Control Diet will be comprised of the same foods as the test diets except for the isocaloric substitution of almonds and/or dark chocolate and cocoa for sources of saturated fat; an approximate 250 kcal substitution. In an effort to keep all the diets consistent (except for the specific foods to be tested), the Control Diet will be slightly higher in fiber (20-25g) and lower in cholesterol (~250 mg) than the typical consumption practices (15g and 278 mg, respectively).
16136868|NCT01882881|Other|Dark Chocolate/Cocoa Diet|The Dark Chocolate/Cocoa Diet will include a daily hot cocoa beverage containing 11g of natural cocoa powder and 6 pieces of Hershey's Bliss Dark Chocolate (43g of dark chocolate). This amount of dark chocolate and cocoa will allow for the isocaloric substitution with 1.5oz almonds. The total diet will provide ~33% of calories from fat. The SFA (~12%) in the Dark Chocolate/Cocoa Diet will match that of the Control Diet and be slightly higher than the Almond Diet, however the saturated fat will be comprised largely of stearic acid from the dark chocolate; cholesterol will be ≤200 mg/day. The fiber in the Dark Chocolate/Cocoa Diet will be higher than both the Control and Almond Diets due to the fiber content of the dark chocolate (~9g).
16136869|NCT01882881|Other|Almond Diet|The Almond Diet will include 1.5 oz of almonds daily and provide ~34% of calories from fat. The Almond Diet will be lower in SFA than the Control and Dark Chocolate/Cocoa Diets, containing ~ 8-9% calories from SFA. In addition, both almond containing diets will be slightly higher in MUFA and PUFA than the Control and Dark Chocolate/Cocoa Diets, as a result of the nutrient profile of the almonds. Cholesterol will be ≤200 mg/day; fiber will be increased compared to the Control Diet due to the inclusion of almonds.
16136870|NCT01882881|Other|Dark Chocolate/Cocoa + Almond Diet|This diet is designed to test the additive effects of combining consumption of dark chocolate and cocoa with almonds. The diet will include the same hot cocoa beverage (11g) and dark chocolate pieces (43g) plus 1.5 oz of almonds. Additional high saturated fat foods are removed from the Control Diet to account for both the dark chocolate and almonds. As a result, the total fat will be similar to the other three test diets at ~34-35% and the SFA will match that of the Almond Diet at ~8-9%. The fiber content of this diet will be highest (~35g); cholesterol will remain ≤200 mg/day.
16136871|NCT01882868|Drug|Aflibercept|Pharmaceutical form: Concentrated solution (100 mg/4 mL [25 mg/mL], 200 mg/8 mL [25 mg/mL]) for infusion; Route of administration: Intravenous
16136872|NCT01882868|Drug|Levofolinate|Pharmaceutical form: Solution for infusion (marketed formulation); Route of administration: Intravenous
16136873|NCT01882868|Drug|Irinotecan|Pharmaceutical form: Solution for infusion (marketed formulation); Route of administration: Intravenous
16136874|NCT01882868|Drug|5-FU|Pharmaceutical form: Solution for infusion (marketed formulation); Route of administration: Intravenous
16136875|NCT01882842|Procedure|Endometrial biopsy|Endometrial biopsy will be performed in the study group and timed according to a positive urinary LH (ovulation) kit at LH+7 to +9 days.
16136876|NCT01882842|Device|Transvaginal ultrasound|A detailed assessment of the endometrium will be performed including two- and three- dimensional ultrasound, as well as power Doppler acquisitions.
16136877|NCT01882829|Drug|dextromethorphan/quinidine|up to 45/10 mg every 12 hours in patients with TRD with a short 7 day tapering period in which subjects are tapered off 45/10 mg dose from twice a day to once daily for an additional 7 days at post 8-week treatment period to minimize the potential for discontinuation effects
16136878|NCT01882816|Radiation|IMRT|Patients will receive intensity-modulated radiation therapy (IMRT) in once-daily fractions (Monday through Friday, excluding holidays). A total dose of 70Gy is planned. Patients will be seen weekly during radiation as per standard procedure at MSKCC
16136879|NCT01882816|Device|DWI MRI|The DW and multiparametric MRI will be recommended for 3 months, 6 months, and then every 6 months (all +/- 4 weeks) until 2 years post-RT unless contraindicated for main campus patients only. This schedule may be altered, as clinically indicated.
16136880|NCT01882816|Drug|Doxorubicin|Low dose radiosensitizing doxorubicin at 10 mg/m2 will be administered weekly.
16136881|NCT01882816|Other|Modified Barium Swallow Impairment Profile (MBSImP)|The MBSImP is a standardized tool which assesses swallowing impairment as it relates to oral, pharyngeal, and esophageal impairments.
16136882|NCT01882803|Drug|Duvelisib|PI3K Inhibitor
16136883|NCT01882777|Behavioral|Household drinking water filters and cookstoves|The intervention consists of providing households with a household-based drinking water filter (Lifestraw® Family version 2.0) and high efficiency cook stoves (Eco Zoom) as well as instructions on how to use them. The intervention is delivered at community level through community health workers (CHWs). Following initial distribution of the products, CHWs visit households fortnightly to reinforce messages about correct and consistent use.
16136884|NCT01882764|Drug|HMPL-004|Remitters and responders from HMPL-004 Induction study and patients complete the 8-week Open Label Induction Phase will be given HMPL-004 orally three times per day with total daily dose of 1800 mg for 52 weeks.
16136886|NCT01882751|Device|Conformis CR Total Knee Replacement|iTotal CR by Conformis
16136887|NCT01882751|Device|Off the Shelf|A standard knee replacement not using ConforMIS' iFit technology
16136888|NCT01882725|Device|Erchonia HP Scanner (HPS)|The Erchonia HP Scanner (HPS) Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration.
16136889|NCT01882712|Drug|CD07805/47 Gel 0.5%|
16136890|NCT01882712|Drug|CD07805/47 Gel Placebo|
16136891|NCT01882699|Device|Cereve Sleep System|cerebral hypothermia
16136892|NCT01882686|Other|Classification Based Cognitive Functional Therapy|A novel multidimensional classification system has been developed incorporating the biopsychosocial model, which subgroups patients based on their presentation. This subclassification is the base for matched interventions directed at the maladaptive cognitive, physical and lifestyle behaviours associated with the disorder. The intervention is called 'cognitive functional therapy' as it directly challenges these behaviours in a functionally specific and graduated manner.
16136893|NCT01882673|Behavioral|Brief Computer Motivational Interviewing for Smoking Cessation|Brief computer motivational interviewing intervention to motivated tobacco quitline use
16136894|NCT01882673|Behavioral|Nutrition Control|Computer delivered nutrition education control condition
16136895|NCT01882660|Drug|Decitabine|
16136896|NCT01882647|Drug|000-0551 Lotion|
16136897|NCT01882647|Drug|Vehicle Lotion|
16136898|NCT01882634|Device|Ultrasound (Trademark:VScan; Manufacturer:General Electric)|Standardized measurements were made and aorta will be visualized in a minimum of three hard copy images: upper transverse projection abdominal aorta at the level of epigastrium (celiac trunk) lower transverse section for distal view of aorta (pre-bifurcation), and longitudinal section (with origin of celiac trunk or superior mesenteric artery), determining the maximum diameter in centimeters (cm)
16136899|NCT01882621|Drug|Monosialoganglioside(GM1)|80mg,ivdrip (in the vein) on day 0 - day 3 of each 21 day cycle. Number of Cycles: 4-6 cycles.
16136900|NCT01882621|Drug|normal saline|80mg,ivdrip(in the vein) on day 0-3 of each 21 day cycle. Number of Cycles: 4-6 cycles.
16136901|NCT01882608|Other|Mental Health Telemetry (MHT)|Ecological momentary assessment (EMA) focuses on using data collected from subjects living their daily lives in their natural environments using minimally invasive techniques to improve the quality of the data collected. MHT is an evolution of EMA. MHT was developed at Sunnybrook in partnership with the University of Toronto; it uses cell phones to collect self-report data on symptoms of illness and then transmit it in real-time to a central database. Principal advantages of MHT over EMA include the ability to time- and date-stamp data, thus eliminating retrospective record completion, and the ability to observe and monitor data flow in real-time, without having to wait for participants to upload or deliver the data (e.g., at their next doctors' appointment).
16136902|NCT01882595|Other|Nebulization through the tracheostomy|Each subject received two nebulization sessions under spontaneous breathing in a sitting position. The first session was performed prior to tracheostomy removal. During the first nebulization, subjects inhaled the aerosol through the tracheostomy, cuff inflated and inner cannula removed.
16136903|NCT01882595|Other|Nebulization through the mouth|Each subject received two nebulization sessions under spontaneous breathing in a sitting position. The second nebulization was performed when the tracheostome was totally scarred. During the second nebulization, subjects inhaled the aerosol a mouth piece and wore a nose clip.
16136904|NCT01882556|Drug|onabotulinumtoxinA|
16136905|NCT01882556|Drug|Placebo|
16136906|NCT01882543|Drug|AQX-1125|Synthetic SHIP1 activator
16136907|NCT01882543|Drug|Placebo|Double blind placebo capsule
16136908|NCT01882530|Drug|Paracetamol|
16136909|NCT01882530|Drug|Nefopam|
16136910|NCT01882530|Drug|Ketoprofen|
16136911|NCT01882530|Drug|Morphine|
16136912|NCT01882517|Dietary Supplement|Yogurt that contains plant stanol esters|
16136913|NCT01882517|Dietary Supplement|Placebo yogurt|
16136914|NCT01882504|Drug|gevokizumab|
16136915|NCT01882491|Drug|Placebo|Solution for subcutaneous injection
16136916|NCT01882491|Drug|gevokizumab|Solution for subcutaneous injection
16136917|NCT01882465|Device|etafilcon A|Lenses to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
16136918|NCT01882465|Device|2-HEMA, EGDMA Non-ionic|Lenses to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
16136919|NCT01882465|Device|hefilcon A|Lenses to be worn in a daily wear modality, and disposed of at the end of each follow-up visit.
16136920|NCT01882452|Behavioral|Memory Specificity Training|This intervention is a manualised, structured treatment delivered over 5 x 60 minute sessions to groups of 5-8 individuals. This treatment involves repeated practice of retrieving specific autobiographical memories in response to positive, negative and neutral cue words. There is a single psychoeducation component in the first session about memory difficulties common in depression which provides the rationale for this treatment. The training is supplemented by weekly homework practice.
16136921|NCT01882452|Behavioral|Education and Support|The education-and-support comparison condition is matched with the experimental arm for length and format (ie., 5 x 60 minute weekly sessions in groups of 5-8 individuals). Groups receive a single psychoeducation component where information about depression is provided. This is followed by non-directive support where participants are encouraged to raise different kinds of events that occur each week for discussion in the group. The sessions are supplemented by a homework diary where participants will be invited to note down an event that occurs each day, which may be positive, negative, or benign and non-emotional in nature. This material will provide the basis for discussion in the weekly group meetings.
16136922|NCT01882439|Drug|Tofacitinib|tablets, 5 mg BID x 6 months
16136923|NCT01882439|Drug|Tofacitinib|tablets, 10 mg BID x 6 months
16136924|NCT01882439|Other|Placebo|tablets, to match tofacitinib 5 mg BID x 3 months
16136925|NCT01882439|Drug|Tofacitinib|tablets, 5 mg BID x 3 months
16136926|NCT01882439|Other|Placebo|tablets, to match tofacitinib 10 mg BID x 3 months
16136927|NCT01882439|Drug|Tofacitinib|tablets, 10 mg BID x 3 months
16136928|NCT01882426|Other|Enhanced treatment algorithm|Practitioners assigned to the intervention arm will be educated on the use of the Enhanced Algorithm.
16136929|NCT01882426|Other|Usual Care|usual step care practice
16136930|NCT01882413|Other|No intervention|No intervention
16137022|NCT01881789|Drug|Lenalidomide|Administered orally at a dose of 25 mg on days 1 through 21 of each 28-day cycle for a maximum of 24 cycles.
16136931|NCT01882400|Drug|Bisphosphonate treatment|Treatment with Calcium, vitamin D and a weekly bisphosphonate. Comparison of bone mass, fracture rate, pain intensity and scoliosis progression before and after treatment
16136932|NCT01882387|Drug|TXA127|Injection, 300mcg/kg/day for 28 days
16136933|NCT01882374|Drug|TXA127|Injection, 300mcg/kg/day for 28 days
16136934|NCT01882361|Drug|injectable naltrexone|Vivitrol is an extended-release, microsphere formulation of naltrexone designed to be administered by intramuscular (IM) gluteal injection every 4 weeks or once a month. After IM injection, the naltrexone plasma concentration time profile is characterized by a transient initial peak, which occurs approximately 2 hours after injection, followed by a second peak observed approximately 2 - 3 days later. Beginning approximately 14 days after dosing, concentrations slowly decline, with measurable levels for greater than 1 month.
16136935|NCT01882361|Drug|placebo comparator|this placebo has no specific pharmacological activity
16136936|NCT01882348|Behavioral|CEASE Intervention|The CEASE intervention works within existing systems of care to address parental smoking. Elements include (1) Identification of smokers and self-assessment of quitting preferences; (2) Counseling (brief motivational messaging elements include collaborative goal setting, set quit date, personal barriers to quitting, problem-solving strategies, implementing smoke-free homes and cars, and social support, strategies shown to increase satisfaction with the pediatric visit. (3) Medication (NRT prescription and free 1 week supply (while supplies last)-including for those cutting down to quit as recommended in latest guidelines); (4) Quitline enrollment; and (5) Review of CEASE action sheets at each visit until the family is smoke-free.
16136937|NCT01882335|Behavioral|Peer support for exclusive breastfeeding|Pregnant women were identified and randomized to peer support for exclusive breastfeeding in clusters. They were followed up for 6 months post delivery.
16136938|NCT01882322|Drug|Prograf|oral
16136939|NCT01882322|Drug|Advagraf|oral
16136940|NCT01882296|Drug|AGSPT_10|AGSPT 10mg for 7days administration
16136941|NCT01882296|Drug|AGSPT_20|AGSPT 20mg for 7days administration
16136942|NCT01882296|Drug|AGSPT_40|AGSPT 20mg x 2tablet for 7days administration
16136943|NCT01882296|Drug|Pantoprazole_20|Pantoprazole 20mg for 7days administration
16136944|NCT01882296|Drug|Pantoprazole_40|Pantoprazole 40mg for 7days administration
16136945|NCT01882283|Dietary Supplement|Tea Treatment Group|This intervention was a crossover trial, during which each patient experienced both placebo and tea treatment arms
16136946|NCT01882283|Dietary Supplement|Placebo|
16136947|NCT01882257|Device|BiPAP|BiPAP-auto (Phillips Respironics)is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is used to treat obstructive sleep apnea.
16136948|NCT01882257|Device|BiPAP/AVAPS (Phillips Respironics)|BiPAP/AVAPS (Phillips Respironics) is a noninvasive positive pressure ventilation device worn with a mask interface of the subject's choice. It is specifically designed to treat nocturnal hypoventilation due to an underlying neuromuscular disorder.
16136949|NCT01882244|Behavioral|Neural Pathfinder Training|Neural Pathfinder Training consists of game-based computerized training tools that target goal-directed attention regulation. Training will involve 6-8 weeks of 1-2 hour in-person or remote sessions with a trainer involving an average of one session per week; about 15 minutes a week of telephone contacts with the trainer; and approximately 20 hours of homework (35 minutes/5 days a week), consisting of short attentional regulation practice and computer-assisted cognitive training game play.
16136950|NCT01882244|Behavioral|Brain Health Education|Brain Health Education (EDU) will involve 6-8 weeks of 1-2 hour in-person or remote sessions covering brain anatomy and health with a trainer involving an average of one session per week; about 15 minutes a week of telephone contacts with the trainer; and approximately 20 hours of homework (35 minutes/5 days a week), consisting of computer game play involving decision-making and motor skills.
16136951|NCT01882231|Other|DCE-MRI, DW-MRI, MT-MRI, and CEST-MRI|Imaging techniques using high-field MRI to make quantitative assessments in patients with osteosarcoma or Ewing sarcoma
16136952|NCT01882218|Drug|Galactose|After surgery, galactose will be dripped into the belly for up to 24 hours after surgery
16136953|NCT01882218|Drug|Standard Treatment|Standard liver surgery.
16136954|NCT01882205|Device|Virtual chromoendoscopy|
16136955|NCT01882205|Procedure|Chromoendoscopy|Panchromocolonoscopy with methyleen blue 0.1%
16136956|NCT01882192|Behavioral|Family physical activity planning|"This material will include skill training content (workbook how to plan for family physical activity) and practical material to create a plan (i.e., a colourful dry erase wall calendar for family activities with fridge magnets). The skill training material for planning is based on several streams of prior work in the adult physical activity literature. Families were instructed to plan for when, where, how, and what physical activity will be performed commensurate with the creation of implementation intentions/action planning. The workbook, however, also focuses on problem solving barriers to physical activity which is more akin to coping planning and traditional goal setting."
16136957|NCT01882179|Drug|Mineralocorticoid receptor antagonist potassium-canrenoate|
16136958|NCT01882179|Drug|placebo|
16136959|NCT01882166|Drug|fostimon|
16136960|NCT01882166|Drug|puregon|
16136961|NCT01882153|Behavioral|Pivotal Response Training (PRT)|The behaviorally-based intervention is a treatment model that uses the principles of Applied Behavior Analysis (Koegel, Openden, Fredeen, & Koegel, 2006) to increase children's adaptive behaviors and decrease maladaptive behaviors.
16136962|NCT01882153|Behavioral|PACE Therapy|The developmentally based intervention is grounded in a development theory, that focuses on child-directed interactions with warm and caring individuals that aid in acquiring missed developmental and functional milestones.
16136963|NCT01882153|Behavioral|PACE and PRT Hybrid|The hybrid based treatment has an eclectic approach that incorporates both systematic (behaviorally-based) and affect-based learning (developmentally-based)that focuses on increasing children's skill development (http://www.pacificautism.org).
16136964|NCT01882140|Other|Electrical Stimulation by Capacitive Field|
16136965|NCT01882140|Other|Electrical Stimulation by Capacitive Field Placebo Sham|
16136966|NCT01882127|Drug|All-Trans Retinoid Acid(ATRA)|patients in ATRA&High dose-DEX group take All-Trans Retinoic Acid(orally,10mg every 8 hours a day for 12 consecutive weeks) in combination with dexamethasone(intravenously , 40mg/d for 4 consecutive days).
16137094|NCT01881204|Dietary Supplement|Control|Cookies without Hesperidin or Calcilock added.
16136967|NCT01882127|Drug|Dexamethasone|Patients in High dose-DEX treatment group take dexamethasone( orally , 40mg daily for 4 days),patients in ATRA&High dose-DEX group take All-Trans Retinoic Acid(orally,10mg every 8 hours a day for 12 consecutive weeks) in combination with dexamethasone(intravenously , 40mg/d for 4 consecutive days).
16136968|NCT01882101|Procedure|Posterior tibial nerve stimulation|34G needle is introduced percutaneously three finger-breadths superior to the medial malleolus and an electrode is attached to the ipsilateral foot. Electrical stimulation is applied monitoring motor and sensory response. The treatment lasts for 30 minutes, and will be repeated twice a week for 6 weeks.
16136969|NCT01882101|Procedure|Biofeedback|Electrodes are attached to the lower abdomen and acryl plug is inserted into the anal canal. The patients perform pelvic muscle exercise watching EMG activity of themselves. The treatment lasts over 30 minutes, and will be repeated twice a week for 6 weeks.
16136970|NCT01882088|Drug|Mucofalk|Mucofalk 15 g/day i.e. 5 g TID per os, 15-20 min before meal
16136971|NCT01882075|Drug|Open loop|
16136972|NCT01882075|Device|Closed-loop|
16136973|NCT01882062|Drug|Triheptanoin 1g/kg/day|
16136974|NCT01882049|Device|REALIZE Gastric band (ETHICON)|Placement of gastric band around upper stomach
16136975|NCT01882036|Procedure|Gastric Bypass w/ matched hypocaloric diet|Roux en Y Gastric Bypass with Hypocaloric liquid diet for 10 days
16136976|NCT01882036|Other|Hypocaloric diet|Hypocaloric liquid diet for 10 days
16136977|NCT01882010|Procedure|blood draw|week -8
16136978|NCT01882010|Procedure|physical exam and UPDRS part III assessment|week -8
16136979|NCT01882010|Procedure|blood draw|week -4
16136980|NCT01882010|Procedure|physical exam and UPDRS part III assessment|week -4
16136981|NCT01882010|Procedure|blood draw|week 0
16136982|NCT01882010|Procedure|physical exam and UPDRS part III assessment|week 0
16136983|NCT01882010|Procedure|MEG|week 0
16136984|NCT01882010|Drug|sargramostim|"lyophilized 250 micrograms/vial
~6 micrograms/kg daily subcutaneous injection
~56 days"
16136985|NCT01882010|Drug|placebo|saline solution daily subcutaneous injection 56 days
16136986|NCT01882010|Procedure|blood draw|week +2
16136987|NCT01882010|Procedure|physical exam and UPDRS part III assessment|week +2
16136988|NCT01882010|Procedure|blood draw|week +4
16136989|NCT01882010|Procedure|physical exam and UPDRS part III assessment|week +4
16136990|NCT01882010|Procedure|blood draw|week +6
16136991|NCT01882010|Procedure|physical exam and UPDRS part III assessment|week +6
16136992|NCT01882010|Procedure|blood draw|week +8
16136993|NCT01882010|Procedure|physical exam and UPDRS part III assessment|week +8
16136994|NCT01882010|Procedure|MEG|week +12
16136995|NCT01882010|Procedure|blood draw|week +12
16136996|NCT01882010|Behavioral|physical exam and UPDRS part III assessment|week +12
16136997|NCT01882010|Procedure|Motion Analysis|Week -4
16136998|NCT01882010|Procedure|Motion Analysis|Week +8
16136999|NCT01882010|Procedure|Motion Analysis|Week +12
16137000|NCT01881997|Drug|Fentanyl|Fentanyl Intramuscular (IM), 1ugm/kg, x1
16137001|NCT01881997|Drug|Normal Saline|IM normal saline
16137002|NCT01881984|Drug|Ravicti|Open-label design comparing Ravicti at doses of 2, 4, and 6 grams/m2/day
16137003|NCT01881971|Drug|Placebo|suger pill manufactured to mimic crestor pills
16137004|NCT01881971|Drug|Rouvastatin calcium|
16137005|NCT01881958|Drug|DiaPep277®|
16137006|NCT01881945|Other|Non-invasive physiological signal recording on healthy volunteer|
16137007|NCT01881932|Device|Acupuncture using Seirin® needles|"Participants will receive acupuncture weekly until the end of chemotherapy.
~Subjects will receive acupuncture at documented acupoints. To improve blinding effect, the acupuncturist will also tap 2 guiding tubes at 2 sham points , and immediately affix a pair of needles to the surface of the same points with adhesive tape, without needle insertion."
16137008|NCT01881932|Device|Sham Acupuncture using Park Sham placebo acupuncture device|"Participants will receive sham acupuncture until the end of chemotherapy.
~Acupuncturist will insert Park Sham Devices, non-penetrating sham acupuncture device consisting of a retractable needle and an adhesive tube into the sham points, and then immediately apply 2 pieces of adhesive tape next to the needles. In addition, she will tap a mock plastic needle guiding tube on the surface of each of the 8 true points in the arm and leg to produce some discernible sensation and then immediately apply a needle with a piece of adhesive tape to the dermal surface, without needle insertion."
16137009|NCT01881919|Dietary Supplement|Treatment|Address: Nature's Best, Century Place, Tunbridge Wells, Kent, TN2 3BE Phone:+44(0)1892 552030 Email:info@naturesbest.co.uk
16137010|NCT01881919|Dietary Supplement|Control|Address: Fagron GmbH&Co. KG, 22885 Barsbuttel, Germany Phone: +49(0)4067067680
16137011|NCT01881906|Other|Usual care|
16137012|NCT01881906|Other|Exercise|
16137013|NCT01881893|Behavioral|ACHD-CARE Program|The ACHD-CARE program will be provided in eight 90-minute weekly sessions. The intervention includes information about living with congenital heart disease, cognitive behavioral therapy (CBT) and coping techniques, and opportunities for peer interaction.
16137014|NCT01881880|Device|Bilateral mammography with Tomosynthesis|no intervention pre specified to be administered to participants
16137015|NCT01881867|Biological|Glycosylated Recombinant Human Interleukin-7|Given SC
16137016|NCT01881867|Other|Laboratory Biomarker Analysis|Correlative studies
16137017|NCT01881841|Behavioral|cMET|Those in cMET complete the 2-session self-administered computerized intervention which includes 8 exercises designed to encourage adolescents to evaluate the impact of alcohol and other substance use on their health and well-being and consider changing their use.
16137018|NCT01881828|Drug|Metformin (glucophage)|The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.
16137019|NCT01881828|Other|oral placebo|
16137020|NCT01881815|Other|Swabs|There is no intervention only swabs are being used to collect wound fluid samples
16137021|NCT01881789|Drug|Oprozomib|Extended release (ER) tablets administered orally
16137095|NCT01881191|Other|MRI|
16137023|NCT01881789|Drug|Dexamethasone|Administered at 20 mg, orally, on days 1, 2, 8, 9, 15, 16, 22, and 23 of each 28-day cycle. After the first cycle the dose may be decreased to 10 mg/day in participants > 75 years of age, at the discretion of the investigator.
16137024|NCT01881789|Drug|Cyclophosphamide|Administered orally at 300 mg/m² (up to a maximum of 600 mg) on days 1, 8, and 15 of each 28-day cycle for a maximum of 8 cycles of therapy (approximately 8 months).
16137025|NCT01881776|Procedure|ISB|"In SISB group; a 5 cm block needle (Stimuplex®A, B Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). 20 mL 0.5% ropivacaine was injected through the needle.
~For CISB, a 5cm stimulating needle (Contiplex® Tuohy, B. Braun Medical, Bethlehem, PA) was inserted in-plane in order to place the needle tip between the upper and middle trunks of the brachial plexus (C5-C6). A nonstimulating catheter was inserted approximately 3 cm beyond the tip of the needle. 20 mL 0.5% ropivacaine was injected through the catheter."
16137026|NCT01881763|Drug|Ketamine|Ketamine 1-2 mgr/ kg IV
16137027|NCT01881763|Drug|Methohexital|Methohexital 0.5-1mg/kg IV
16137028|NCT01881750|Behavioral|Pivotal Response Training (PRT)|12 week program on instruction of Pivotal Response Training, consisting of group meetings and individual sessions.
16137029|NCT01881750|Behavioral|Parent Education Group (PEG)|12 week program consisting of offering/discussion information for parents. No pivotal response training provided.
16137030|NCT01881737|Drug|Pregnenolone|"With Baseline serving as approximately day 1, twice daily intake of orally administered pregnenolone will occur on a schedule consisting of an up-titration followed by a down-titration as described below.
~Week 1 and 2: 100 mg
~Week 3 and 4: 200 mg
~Week 5 and 6: 300 mg
~Week 7 and 8: 400 mg
~Week 9 -12: 500 mg
~At the end of Week 12, pregnenolone was decreased by 50 mg twice a day every 3 days until it was discontinued.
~If the participant is unable to tolerate a specific dose then he/she will be maintained at the highest tolerated dose until down titration occurs."
16137031|NCT01881724|Behavioral|Sleep education|
16137032|NCT01881711|Device|ShuntCheck-Micro-Pumper (SCMP)|"ShuntCheck uses thermal dilution to detect flow in CSF shunts. CSF is cooled transcutaneously with an ice pack and ShuntCheck's thermosensor detects a temperature drop due to CSF flow downstream of the ice. Micro-Pumper is a handheld device which vibrates the shunt valve to generate a temporary increase in CSF flow in patent but temporarily non-flowing shunts. This flow increase can be detected by ShuntCheck."
16137033|NCT01881711|Device|Imaging|Imaging of ventricle size
16137034|NCT01881698|Other|Platelet function during pregnancy Multiple Electrode Aggregometry (Multiplate@) device|Observation of platelet function in pregnancy
16137035|NCT01881659|Other|HPV screening|Women who signed informed consent will be screened with HPV testing.
16137036|NCT01881646|Radiation|Positron emission tomography (PET) using [11C]PBR28|
16137037|NCT01881633|Drug|ISU302|
16137038|NCT01881633|Drug|Placebo|
16137039|NCT01881620|Device|COMBI TEP : PET / enhanced CT scan|diagnostic imaging exam
16137040|NCT01881607|Behavioral|RESPIRNET Program|"The intervention at the classroom consisted of six sessions with the pupils of one hour each that were conducted by the teacher/tutor. We provided the teachers with a training session and a teachers' guide, and we gave each pupil a workbook with the activities. At the school level, the intervention consisted of four types of posters with specific messages directed to students, teachers, and parents, and the fourth poster type advertised the new smoking laws. we gave teachers and school managers the guide Towards a Smoke-Free School to facilitate the prevention and control of smoking (active and passive) in the school environment. Family level activities: Parents were required to complete the My risk thermometer activity at home with their children. Parents received a brochure with information on the risks of SHS exposure and recommendations to prevent SHS exposure, and a refrigerator magnet with the logo of the program."
16137041|NCT01881594|Procedure|Procedure/Surgery|daily stimulation of efferent loop prior to surgery (ileostomy closure)
16137042|NCT01881581|Biological|Saline Solution|Saline Solution is used as control in all arms.
16137043|NCT01881581|Biological|D-GPEi|D-GPEi is used in Arm A,B,C,G and H.
16137044|NCT01881581|Biological|M-GPE|M-GPE is used in Arm D,E,F,G and H
16137045|NCT01881568|Drug|Tranexamic Acid|Topical administration: 3g of Tranexamic Acid in 100mL of normal saline (0.9% sodium chloride)
16137046|NCT01881568|Drug|Tranexamic Acid|Intravenous administration of two dosis of Tranexamic Acid (15mg/kg of Tranexamic Acid in 100mL of normal saline each)
16137047|NCT01881555|Procedure|invasive coronary angiography|
16137048|NCT01881555|Procedure|Functional testing by fractional flow reserve measurement|Functional testing by fractional flow reserve measurement
16137049|NCT01881516|Device|acupuncture|once per week for 6 weeks，30 mins for each treatment and for seven main acupoints
16137050|NCT01881516|Device|sham acupuncture|the same acupoints and time as in acupuncture arm, but use a Park Sham Device
16137051|NCT01881503|Biological|HBOC-201|HBOC-201 is purified, cross-linked, acellular bovine hemoglobin (Hb) in a modified lactated Ringer's solution.
16137052|NCT01881490|Device|MRE|Developing the Pediatric Crohn's Disease Intestinal Damage Score (pMEDIC score) and the Pediatric MRE-Based Activity Index (PICMI)
16137053|NCT01881477|Procedure|kinetics modalities|"The duration of the intervention will be approximately 30 minutes to 1 hour and will take place 5 days a week. They constantly monitor the vital signs and signs of exercise intolerance.
~The intervention consists of four levels of complexity. The progression in kinetic patterns based on muscle strength during exercise Kinetic methods begin with passive movements and patients are assisted in the movement slowly until they are active, culminating in movements against resistance, in all joints, with a minimum of 10 repetitions for each joint.
~Additionally, it promotes the adoption and sitting positions long and short legged and walk."
16137054|NCT01881464|Device|Endopath from Itamar medical - FDA approved device.|endothelial function assessment by Endopath device
16137055|NCT01881464|Drug|Anti TNF Alfa.|This study will assessed the presence of endothelial dysfunction in patients with Crohn's disease before and after 12 weeks treatment of anti TNF α.
16137056|NCT01881451|Drug|18F-EF5 PET/CT scan|Patients will undergo an investigations 18F-EF5 PET/CT scan.
16137057|NCT01881451|Procedure|Optional biopsy|Patients who choose to participate, will undergo a tissue biopsy.
16137096|NCT01881178|Dietary Supplement|NOPALEA|
16137097|NCT01881165|Drug|Cranberry|
16137098|NCT01881165|Drug|Placebo|
16137058|NCT01881425|Procedure|Glaucoma Surgery|"An initial pocket is created under the conjunctiva and Tenon's capsule and the wound bed is treated for two minutes with mitomycin C (MMC, 0.2 mg/ml)soaked sponges. This is done using a fornix-based conjunctival incision at the corneoscleral junction. A partial thickness scleral flap with its base at the corneoscleral junction after cauterization of the flap area, and a window opening is created under the flap with a Kelly-punch to remove a portion of the sclera, Schlemm's canal and the trabecular meshwork to enter the anterior chamber. An iridectomy is done in many cases to prevent future blockage of the sclerostomy. The scleral flap is then sutured loosely back in place with several sutures. The conjunctiva is closed in a watertight fashion at the end of the procedure."
16137059|NCT01881425|Device|InnFocus MicroShunt|"An initial pocket is created under the conjunctiva and Tenon's capsule and the wound bed is treated for two minutes with mitomycin C (MMC, 0.2 mg/ml)soaked sponges. This is done using a fornix-based conjunctival incision at the corneoscleral junction. After cauterization of the flap area, a knife is used to create a shallow pocket at the scleral surface and an opening into the AC. The device is then threaded through the track until the proximal end is in the anterior chamber and the fin of the device is pushed into the shallow scleral pocket. The device is checked to observe aqueous flow and the distal end placed under the Tenons/conjunctiva. The conjunctiva is closed in a watertight fashion at the end of the procedure."
16137060|NCT01881412|Drug|fluticasone|During discharge, the study MD/nurse informs the family that the child has been randomized to the inhaled corticosteroid (ICS) group, and will be prescribed fluticasone to help control the asthma. The families preferred pharmacy is determined and a prescription for a fluticasone multi-dose inhaler (MDI) provided. Dosing follows the NHLBI asthma guidelines for low dose ICS in this age group (88 mcg administered twice per day, dispense one inhaler, 3 refills). In addition to standard asthma discharge instructions, the family receives specific instructions for ICS administration, possible side effects of medication use, and distinction between controller and quick-relief rescue medications. Parents are instructed to discuss with their primary care provider the length of ICS use.
16137061|NCT01881412|Other|Standard Asthma Discharge Instructions|Study MD or nurse provides asthma discharge instructions using a standardized checklist. The topics covered include 1) description of asthma manifestations related to current visit, 2) signs of respiratory distress family should be looking for, 3) instructions to follow up with the child's primary care provider within one week, 4) provision and review of an asthma action plan, 5) provision of a spacer device to be used with inhalers (if family does not already possess), and 6) smoking cessation advice. (if indicated)
16137062|NCT01881399|Device|Fluorescence cholangiography (da Vinci surgical system)|Patients will received IV injection of ICG intra-operatively, allowing surgeons to view bile ducts under fluorescence imaging using the da Vinci surgical system with fluorescence Imaging system.
16137063|NCT01881399|Other|Virtual cholangiography|Images from virtual cholangiography will be superimposed in real time on images obtained with fluorescence.
16137064|NCT01881399|Procedure|Conventional IOC|Patients will undergo conventional intraoperative cholangiography (with use of radio-opaque dye), allowing surgeons to view bile ducts under Rx imaging.
16137065|NCT01881386|Device|Magnetic Resonance Imaging (MRI)|Magnetic Resonance Spectroscopy
16137066|NCT01881373|Other|CHL program|Multiple component environmentally focused program designed with community engagement.
16137067|NCT01881373|Other|Delayed Optimized CHL program|CHL programs with fewer component and shorter duration.
16137068|NCT01881360|Other|Gluten-free diet|A diet that is free of the gluten component
16137069|NCT01881360|Other|Hypocaloric diet|A standard hypocaloric diet with a daily 1500 caloric intake.
16137070|NCT01881347|Dietary Supplement|Resveratrol|Resveratrol 100 mg daily for 2 weeks followed by resveratrol 300 mg daily for 2 weeks.
16137071|NCT01881347|Dietary Supplement|Placebo|Placebo 100 mg daily for 2 weeks followed by placebo 300 mg daily for 2 weeks.
16137072|NCT01881334|Biological|CliniMACS CD34 Reagent System|The CliniMACS CD34 Reagent System is a medical device that is used in vitro to select and enrich CD34+ cells from heterogeneous hematologic cell populations for transplantation in cases where this is clinically indicated.
16137073|NCT01881321|Behavioral|Counseling Intervention|20-40 minute contraceptive counseling session based on the principles of motivational interviewing
16137074|NCT01881308|Drug|TNF inhibitors|
16137075|NCT01881308|Drug|Synthetic DMARD(s)|
16137076|NCT01881308|Drug|Co-medication: Synthetic DMARDs|Synthetic DMARDs given as co-medication for TNF inhibitors as appropriate.
16137077|NCT01881295|Dietary Supplement|Placebo control|
16137078|NCT01881295|Dietary Supplement|Low dose potassium gluconate|
16137079|NCT01881295|Dietary Supplement|Medium dose potassium gluconate|
16137080|NCT01881295|Dietary Supplement|High dose potassium gluconate|
16137081|NCT01881295|Dietary Supplement|Low dose potato|
16137082|NCT01881295|Dietary Supplement|Medium dose potato|
16137083|NCT01881295|Dietary Supplement|High dose potato|
16137084|NCT01881295|Dietary Supplement|High dose French fries|
16137085|NCT01881295|Dietary Supplement|Basal diet control|
16137086|NCT01881282|Drug|Carraghenates Cream|Carraghenates cream will be administered 3-4 gram (g) each time (one sixth of a piece) through anal canal, twice a day (once in the morning and once in the evening); for consecutive 6 days.
16137087|NCT01881282|Drug|Mayinglong Musk Hemorrhoid Ointment|Mayinglong musk hemorrhoid ointment will be administered 2 g each time through anal canal, twice a day (once in the morning and once in the evening) for consecutive 6 days.
16137088|NCT01881230|Drug|nab-Paclitaxel|nab-Paclitaxel 125 mg/m^2 by IV administration over 30 minutes on Days 1 and 8 of each 21-day treatment cycle.
16137089|NCT01881230|Drug|Carboplatin|Carboplatin at an AUC of 2 on Days 1 and 8 of each 21-day cycle by IV administration
16137090|NCT01881230|Drug|Gemcitabine|Gemcitabine 1000 mg/m^2 on Days 1 and 8 of each 21-day treatment cycle.
16137091|NCT01881217|Drug|BAY1179470|BAY1179470 will be administered as a 1-hour intravenous infusion.
16137092|NCT01881204|Dietary Supplement|Hesperidin and Calcilock|Hesperidin (552mg) and Calcilock® (amount per day: Calcium: 684 mg; Phosphorus: 282mg; Magnesium: 102mg; Zinc: 2.86mg; Vitamin C: 20 mg; Vitamin K1: 28µg; Vitamin D: 1.86µg) will be administered in the form of cookies (biscuit).
16137093|NCT01881204|Dietary Supplement|Hesperidin|Hesperidin (552mg) will be administered in the form of cookies (biscuit).
16137169|NCT01880567|Other|Laboratory Biomarker Analysis|Correlative studies
16137099|NCT01881152|Other|Educational campaign|Multilevel educational campaign on stroke sympton recognition and the need for calling the Emergency Services
16137100|NCT01881152|Other|Usual care|Information on stroke usually delivered at the community level.
16137101|NCT01881139|Behavioral|exercise training|
16137102|NCT01881126|Drug|bimatoprost 0.01%|Bimatoprost 0.01% administered to both eyes once daily for 12 weeks.
16137103|NCT01881126|Drug|travatan 0.004%|Travatan 0.004% administered to both eyes once daily for 12 weeks.
16137104|NCT01881126|Drug|timolol 0.5%|Timolol 0.5% administered to both eyes once daily for 12 weeks.
16137105|NCT01881126|Drug|hypromellose 0.3%|Hypromellose 0.3% lubricant eye drops (for masking purposes) administered to both eyes once daily for 12 weeks.
16137106|NCT01881113|Drug|AC-170 0.24%|1 drop in each eye at 2 separate times during a 14 day period
16137107|NCT01881113|Drug|AC-170 0%|1 drop in each eye at 2 separate times during a 14 day period
16137108|NCT01881100|Other|resin infiltration|The test group (41 children) had caries lesions treated with the resin infiltration technique using Icon by the following procedure: rubber dam applying; etching with 15% hydrochloric acid for 120 s; surface rinsing and drying; dehydrating with ethanol for 30 s and air-drying; infiltrant resin infiltration with a syringe for 180 s; resin polymerization (polymerized by blue light - wavelength of 450 nm and intensity of 800mW/cm2; resin reapplication for 60 s and polymerization; rubber dam removal, and working on the infiltrated lesion with polishing rubbers. After the procedure fluoride varnish was applied.
16137109|NCT01881100|Other|fluoride varnish|All tooth surfaces including WSL treated with fluoride varnish (2,26% F, Duraphat ® Colgate Palmolive, Hamburg, Germany).
16137110|NCT01881087|Drug|Hyperbaric Levobupivacaine 0.75%|Each 4 ml of the administred solution contains: Chlorhydrate Levogyre Bupivacaine 30 mg, Glucose 290.8 mg and water for injection c.s.
16137111|NCT01881074|Drug|Triclosan containing toothpaste|Type II diabetic patients will be instructed to brush their teeth at the same time day and with the same frequency as usual for them using only the triclosan containing toothpaste provided to them. Additional tubes of triclosan containing toothpaste will be provided to the participants for the duration of the study as needed. Following their baseline appointment, patients will be asked to return at 6 weeks, 3, 6, 9 and 12 months for an oral exam and dental cleaning. Samples will be collected at baseline, 3, 6 and 12 months. Samples collected may include venous blood, gingival crevicular fluid, plaque and saliva. Female study participants may be asked to perform a pregnancy test.
16137112|NCT01881074|Drug|Non-triclosan containing toothpaste|Type II diabetic patients will be instructed to brush their teeth at the same time day and with the same frequency as usual for them using only the non-triclosan containing toothpaste (i.e. placebo) provided to them. Additional tubes of non-triclosan containing toothpaste will be provided to the participants for the duration of the study as needed. Following their baseline appointment, patients will be asked to return at 6 weeks, 3, 6, 9 and 12 months for an oral exam and dental cleaning. Samples will be collected at baseline, 3, 6 and 12 months. Samples collected may include venous blood, gingival crevicular fluid, plaque and saliva. Female study participants may be asked to perform a pregnancy test.
16137113|NCT01881048|Dietary Supplement|Omega-3 fatty acid|Given PO
16137114|NCT01881048|Drug|Celecoxib|Given PO
16137115|NCT01881035|Procedure|Renal nerve denervation|Renal nerve denervation is performed by catheter ablation of renal arteries influencing the sympathetic nerves.
16137116|NCT01881022|Behavioral|Psychosexual Intervention|Couples will complete six weekly psychosexual counselling sessions. Each session will focus on areas relevant to sex therapy and sexual dysfunction in couples facing breast cancer (e.g. education, communication, body imagery, sensate focusing, and problem solving). Sessions will be one hour in length (Note: Session 1 will be 1.5 hours), during which couples will meet with a facilitator via videoconferencing.
16137117|NCT01881009|Device|Hybrid Closed-loop System|Medtronic Revel insulin pump, Enlite 3 sensor, Minimed transmitter, PID-IFB (proportional-integral-derivative based with insulin feedback) algorithm on an Android platform with remote monitoring.
16137118|NCT01881009|Device|Sensor-augmented pump|Medtronic Revel insulin pump, Enlite 3 sensor, Minimed transmitter.
16137119|NCT01880996|Other|Tai-chi/Qi-gong|Tai-chi/Qi-gong employs a series of positions and movements that are performed in a slow, flowing manner to help a person concentrate on breathing and motion. The treatments will take place once a week at the Dept. of the Gyneco-oncology and the patients will be instructed to practice tai-chi at home on a daily basis
16137120|NCT01880970|Other|starter infant formula with pro and prebiotics|
16137121|NCT01880970|Other|Placebo comparator|
16137122|NCT01880957|Drug|Lithium|
16137123|NCT01880957|Drug|Lamotrigine|
16137124|NCT01880944|Other|NC-MRI, CE-MRI|non-contrast spine MRI(NC-MRI) contrast-enhanced spine MRI(CE-MRI)
16137125|NCT01880931|Drug|Remifentanil|The effect site concentration of remifentanil
16137126|NCT01880905|Procedure|Measure of uteroovarian ligament length during gynecological surgery|
16137127|NCT01880892|Procedure|Cricopharyngeal myotomy|Endoscopic laser cricopharyngeal myotomy is one of the standard treatments for Zenker's Diverticulum. It takes about 30 minutes and at our institution requires a one night of observation in the hospital.
16137128|NCT01880892|Device|Restech's Dx-pH Probe|This is not an intervention, but a newer device that measure the pH of the nasopharynx and detects laryngopharyngeal reflux. We will perform 24 hour tests with this device to see if there is an increase in laryngopharyngeal reflux follow cricopharyngeal myotomy.
16137129|NCT01880879|Device|helios stent|the group with helios stent implanted
16137130|NCT01880866|Drug|(-)-Epicatechin|A single dose of purified (-)-epicatechin will be administered orally to subjects after a regularly scheduled right heart catheterization. The subjects will be monitored for 5 hours and released.
16137131|NCT01880853|Other|mammography|participants were screened by mammography alone every year
16137132|NCT01880853|Other|ultrasound|participants were screened by ultrasound alone every year
16137133|NCT01880853|Other|mammography and ultrasound|Participants were screened by both mammography and ultrasound every year
16137134|NCT01880840|Drug|205.5 mcg of azelastine hydrochloride|nasal spray
16137135|NCT01880840|Drug|137 mcg of azelastine hydrochloride|nasal spray
16137170|NCT01880567|Biological|Rituximab|Given IV
16137535|NCT01877642|Drug|Placebo IM|intramuscular placebo to mimic lorazepam 1 mg IM
16137141|NCT01880814|Behavioral|Cognitive Behavioral Therapy (CBT)|Children will first be randomized into Stage 1 of CBT or Caregiver-Child Treatment. Stage 1 will include six sessions. After Stage 1, child's response to treatment will be evaluated. Responders will be re-randomized into Stage 2 of no treatment or continuation of CBT. If randomized to no treatment, termination session will be completed. If randomized to continuation of CBT, the treatment will include six sessions and a termination session. Insufficient responders will be re-randomized into Stage 2 of continuation of CBT or Caregiver-Child Treatment. Stage 2 will include six sessions and a termination session.
16137142|NCT01880814|Behavioral|Caregiver-Child Treatment|Children will first be randomized into Stage 1 of CBT or Caregiver-Child Treatment. Stage 1 will include six sessions. After Stage 1, child's response to treatment will be evaluated. Responders will be re-randomized into Stage 2 of no treatment or continuation of Caregiver-Child Treatment. If randomized to no treatment, termination session will be completed. If randomized to continuation of Caregiver-Child Treatment, the treatment will include six sessions and a termination session. Insufficient responders will be re-randomized into Stage 2 of continuation of Caregiver-Child Treatment or CBT. Stage 2 will include six sessions and a termination session.
16137143|NCT01880775|Drug|Prilocaine|experimental
16137144|NCT01880775|Drug|Bupivacaine|marcaine heavy 0.5% 7.5 mg intrathecal
16137145|NCT01880749|Drug|RAD001|
16137146|NCT01880736|Drug|insulin degludec|Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered under the skin OD with the option to vary time of administration within a window of plus/minus 8 hours. A maximum of 3 pre-trial OADs are allowed during the trial at an unchanged, stable dose level and dosing frequency.
16137147|NCT01880736|Drug|insulin degludec|Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered under the skin OD at the same time each day. A maximum of 3 pre-trial OADs are allowed during the trial at an unchanged, stable dose level and dosing frequency.
16137148|NCT01880736|Drug|insulin degludec|Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered subcutaneously (under the skin) OD at the same time each day. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) are allowed during the trial at an unchanged, stable dose level and dosing frequency.
16137149|NCT01880723|Drug|Albuterol|2.5 mg diluted in 3mL normal saline nebulized using a Power Neb2 nebulizer
16137150|NCT01880723|Drug|Placebo saline|nebulized 3mL normal saline) using a Power Neb2 nebulizer
16137151|NCT01880710|Procedure|Subtotal hysterectomy|Subtotal abdominal hysterectomy where the body of the uterus is removed but the cervix is spared.
16137152|NCT01880710|Procedure|Total Hysterectomy|total abdominal hysterectomy where the body as well as the cervix of the uterus are removed.
16137153|NCT01880697|Biological|TIVc|Trivalent Influenza Virus Vaccine (surface antigen, inactivated, cell-based)
16137154|NCT01880671|Device|Inactive Migraine Medical Device|
16137155|NCT01880671|Device|Migraine Medical Device|
16137156|NCT01880658|Drug|Capecitabine|Capecitabine 1000mg/m2,po(orally) on day 1-14 of 21 day cycle. Number of cycles: 16 cycles (1 year)
16137157|NCT01880645|Procedure|Fine Needle Aspiration (FNA)|If patient received chemotherapy before surgery, fine needle aspiration (FNA) performed of any abnormal lymph nodes either right before or during standard breast and underarm surgery. To perform FNA, area is numbed with anesthetic and a needle is inserted into the affected area so that cells can be collected.
16137158|NCT01880645|Procedure|Ultrasound|Patient receives an ultrasound of lymph nodes at diagnosis and on the day of surgery. Marker clip(s) placed using a needle in the abnormal lymph node(s).
16137159|NCT01880645|Procedure|Breast Surgery + Lymph Node Removal|Patient receives standard breast and underarm surgery (underarm lymph node removal and either a partial mastectomy or total mastectomy with or without reconstruction).
16137160|NCT01880632|Drug|XELOX|"Patients will be given the perioperative chemotherapy as below once recruited:
~Capecitabine ：500 mg tablets（Roche） Oxaliplatin：50mg/10ml（according to daily practice in each center）
~Schedule of Oxaliplatin plus capecitabine (XELOX) will be as follow:
~Capecitabine 1000 mg/m2 ，orally taken 30 minutes after meal, bid ， d 1~14 every 3 weeks(treatment for 2 weeks and rest 1 week) Oxaliplatin：130mg/m2， iv infusion over 2h，d1,every 3 weeks"
16137161|NCT01880619|Drug|Tamsulosin|Patients in this arm will receive Tamsulosin 0.4 mg daily
16137162|NCT01880619|Drug|Solifenacin|Patients in the arm will receive Solifenacin
16137163|NCT01880619|Drug|Control|Patients in this are will receive placebo
16137164|NCT01880606|Procedure|colonoscopy with endomicroscopy|Examination will be performed in two steps. On the way from rectum to caecum, mucosa will be evaluated with white light endoscopy and random biopsies will be taken according to the routine standard with minimum of 2 biopsies from each 10 cm of colon. On the way back (from caecum to rectum) mucosa will be stained with indigo carmine and after intravenous fluorescein injection all macroscopically abnormal lesions will be examined by endomicroscopy and biopsied. Additionally, all places where random biopsies were taken will be also examined with endomicrosopy.
16137165|NCT01880593|Drug|Lithium|Subjects in this arm take 600-1200mg of Lithium pills at night for duration of the study.
16137166|NCT01880593|Drug|Ketamine|
16137167|NCT01880593|Drug|Placebo|Subjects in this arm take placebo pills at night for duration of the study.
16137168|NCT01880567|Drug|Ibrutinib|Given PO
16137366|NCT01878994|Behavioral|Nereu group|
16137171|NCT01880554|Device|Contrast-enhanced intraoperative ultrasound|"Once the patient is included in the study, a staging procedure is performed in three stages before hepatic metastases treatment:
~Step # 1 preoperative (maximum 8 weeks before surgery Steps # 2 and # 3 intraoperative performed by the same surgeon in 2 stages"
16137172|NCT01880541|Other|hypnosedation|hypnosedation
16137173|NCT01880541|Other|general anesthésia|general anesthesia
16137174|NCT01880528|Drug|lisinopril|Given PO
16137175|NCT01880528|Drug|placebo|Given PO
16137176|NCT01880515|Drug|Tetracycline|The experimental group will receive tetracycline 250mg every 12 hours for 1 month the same day at initiation of BIBW2992 whereas the non-intervention group will recieve general dermatological recomendations while on treatment with BIBW2992.
16137177|NCT01880502|Drug|Belviq 10mg|Belviq 10mg single dose administration
16137178|NCT01880502|Drug|Belviq 20mg|Belviq 20mg single dose administration
16137179|NCT01880502|Drug|Placebo|Placebo single dose administration
16137180|NCT01880489|Behavioral|MI + CBST Intervention|The intervention focuses on exploring health goals, creating an action plan, learning about the impact stress, stigma, and substance use can have on health, improving personal growth and social support, and connecting with resources. The first two sessions will be primarily Motivational Interviewing and will explore participants' feelings about their sexual risk, substance use, non-medically monitored hormone and silicone use, and any other issues. Group sessions (Sessions 3-6) will incorporate Cognitive Behavioral Skills Training focusing barriers to physical and mental health. The last session will focus on reviewing progress toward health goals, identifying barriers to change, and generating a plan for connection to ongoing care to reach target health goals.
16137181|NCT01880476|Other|Home visits and group program|Participants will receive up to three home visits by a Registered Nurse and two home visits by a Registered Dietitian over the 6-month intervention period. Participants will also be invited to attend a monthly Diabetes Wellness Day group program which will include diabetes education, interaction with peer volunteers, group exercise, and a meal. The Registered Nurse will coordinate care to help participants access necessary community supports and services and lead monthly interprofessional case conferences to develop a client-centred plan of care for each study participant.
16137182|NCT01880463|Drug|Omega-3 fatty acids (fish oil)|
16137183|NCT01880463|Dietary Supplement|Vitamin D3|
16137184|NCT01880463|Dietary Supplement|Vitamin D3 placebo|
16137185|NCT01880463|Drug|Fish oil placebo|
16137186|NCT01880450|Behavioral|Project Prepared|Behavioral intervention to reduce sexual risk and promote healthy relationships
16137187|NCT01880450|Behavioral|TEEN|Control condition the promote communication, decision-making skills etc.
16137188|NCT01880437|Drug|cytarabine|Cohort 2: 20 mg sc daily for 10 days starting Day 1, with a possible further cycle of 20 mg sc daily for 5 days starting no earlier than Day 29
16137189|NCT01880437|Drug|vismodegib|Cohorts 1 and 2: 150 mg orally daily
16137190|NCT01880424|Drug|Placebo|matching Placebo Capsules, Oral, once daily
16137191|NCT01880424|Drug|Linaclotide|Linaclotide 290 ug Capsules, Oral, once daily
16137192|NCT01880411|Biological|PEK Fusion Protein Vaccine|PEK (PE-E7-K3), a recombinant protein combined with GPI-0100 adjuvant
16137193|NCT01880398|Other|Kshar Sutra|The Kshar Sutra was a standard medicated thread smeared with Kshar of Apamarga (Achyranthus aspera), Shnuhi (Eforbia Nerrifolia) which has quality of cutting and Haridra(Curcuma Longa) which is used as a antiseptic. The ph value of the thread thus prepared was determined and its sterilization effected by ultraviolet radiation. The alkalinity of Kshar Sutra was 9.2ph.
16137194|NCT01880385|Biological|Bevacizumab|During neoadjuvant phase: 15 mg/kg, d1 q3w, 4 cycles
16137195|NCT01880385|Drug|Cyclophosphamide|Neoadjuvant: 500 mg/m2 d1 q3w, 4 cycles
16137196|NCT01880385|Drug|epirubicin hydrochloride|Neoadjuvant: 100 mg/m2, d1 q3w, 4 cycles
16137197|NCT01880385|Drug|fluorouracil|Neoadjuvant: 500 mg/m2, d1 q3w, 4 cycles
16137198|NCT01880385|Drug|Docetaxel|Adjuvant: 100 mg/m2 q3w, 4 cycles
16137199|NCT01880385|Biological|Trastuzumab|Adjuvant: 8 mg/kg d1 in the 1st cycle then 6 mg/kg for d1 q3w, 17 cycles if tumor overexpress HER2
16137200|NCT01880372|Dietary Supplement|Alpha Lipoic Acid|Same as Arm description
16137201|NCT01880359|Drug|Cisplatin|
16137202|NCT01880359|Radiation|Radiotherapy|
16137203|NCT01880359|Drug|Placebo|
16137204|NCT01880359|Drug|Nimorazole|
16137205|NCT01880346|Dietary Supplement|Vitamin D Powder|Patients will be randomly assigned to a powder supplement of 100,000 IU vitamin D3. Randomization will be in blocks of 4 (meaning for every 4 subjects there will be 2 vitamin D and 2 placebo treated patients). Blood will be drawn by IV catheter at baseline, 2, 4, 8, 12, 24, 48, and 72 hours after vitamin D3 dosing
16137206|NCT01880346|Dietary Supplement|Vitamin D Oil|Patients will be randomly assigned to an oil based supplement of 100,000 IU vitamin D3. Randomization will be in blocks of 4 (meaning for every 4 subjects there will be 2 vitamin D and 2 placebo treated patients). Blood will be drawn by IV catheter at baseline, 2, 4, 8, 12, 24, 48, and 72 hours after vitamin D3 dosing
16137207|NCT01880333|Other|Modified Atkin Diet|Eligible children will be started on Modified Atkins diet with help of trained dietician. Carbohydrates intake will be restricted to 5 grams/ day in children<18 mo and 10grams/day in children 18mo- 3 years.Carbohydrate values of various food items will be explained in detail. Fats (e.g. cream, butter, oils, and ghee) will be encouraged. Proteins (cheese, fish, eggs, chicken, and soya products) will be unrestricted. Calcium and multivitamin supplementation will be done. Syrups will be restricted. Clear carbohydrates free fluids- will not be restricted. Medications will be changed to carbohydrate free preparations, wherever available. Diary of events will be recorded including seizure frequency and any adverse or positive effect. Urine ketones chart will be maintained.
16137208|NCT01880320|Drug|CD0271 0.3% / CD1579 2.5%|
16137209|NCT01880320|Drug|CD0271 0.1% / CD1579 2.5%|
16137210|NCT01880320|Drug|Topical Gel Vehicle|
16137211|NCT01880307|Drug|Azathioprine|
16137212|NCT01880307|Drug|Infliximab|
16137213|NCT01880307|Drug|Prednisolon|
16137214|NCT01880294|Drug|No intervention|Asian participants diagnosed with chronic constipation using ANMA diagnostic questionnaire will be observed.
16137215|NCT01880281|Other|Meat and vegetable diet|After having a diet of 3 days and the investigational's day, the volunteers will have the other diet
16137216|NCT01880268|Device|BCI-controlled neurorehabilitation device|"Brain computer interface (BCI) -controlled neurorehabilitation device uses a participant's EEG to control with movements of an ordinary rehabilitation device (an upper limb ergometry, arm bike)"
16137217|NCT01880268|Behavioral|Standard rehabilitation therapy|Standard rehabilitation therapy for patient with stroke includes 1 hour of physical therapy and 1 hour of occupational therapy
16137218|NCT01880255|Device|Repetitive Transcranial Magnetic Stimulation|rTMS is a non-invasive procedure involving the use of magnetic fields to stimulate nerve cells.
16137219|NCT01880216|Drug|Bemiparin sodium|subcutaneous application daily for 7±2 days
16137220|NCT01880216|Drug|Enoxaparin sodium|subcutaneous for 7±2 days
16137221|NCT01880203|Procedure|aspiration in thyroid node for Molecular Cytogenetic Analysis.|
16137222|NCT01880190|Other|Ringer's Lactate|
16137223|NCT01880190|Other|HES 130/0.4 and Ringer's Lactate|
16137224|NCT01880151|Device|EEG|EEG recorded during a resting condition and during an episodic memory task condition
16137225|NCT01880138|Other|watching animated cartoon before general anesthesia|
16137226|NCT01880138|Other|not watching animated cartoon beofre general anaesthesia|
16137227|NCT01880125|Drug|Tramadol HCI/Acetaminophen|Test drug: Tramadol HCI/Acetaminophen 75/650mg, two times daily. Reference drug: Tramadol HCI/Acetaminophen 37.5/325 mg, four times daily.
16137228|NCT01880112|Drug|Cefazolin|Cefazolin will be administered as pre-operative prophylaxis in normal weight patients undergoing Cesarean delivery. Tissue and serum levels will be measured at the time of the incision and when the incision is closed.
16137229|NCT01880099|Drug|placebo|placebo compared to 8mg of Galantamine
16137230|NCT01880099|Drug|Galantamine 8mg|8mg of galantamine compared to placebo
16137231|NCT01880099|Drug|Galantamine 16mg|16mg of galantamine compared to placebo
16137232|NCT01880086|Drug|Clomiphene citrate|
16137233|NCT01880086|Drug|Placebo|Placebo pill that will have appearance identical to the treatment pill but will not contain active medication.
16137234|NCT01880073|Device|FemVue device|The device will be used in conjunction with what is now considered the standard of care to determine if it's as effective.
16137235|NCT01880060|Behavioral|INCENT weight loss program|Tangible incentives seem to be effective in enhancing short term, but not long-term weight loss. The monetary rewards are based on participant quarterly weigh-ins and the monetary amount of incentive will be identical to the percentage of body weight lost. Participants who lose 1, 2, 3, 4, or 5% of their body weight will then be compensated with 1, 2, 3, 4, or 5 dollars per month. Dollar amounts for participants that lose more than 5% of initial body weight then increase by increments of 5 (e.g., 5-9% weight loss = $5; 10-14%=$10; 15-19%=$15; >20%=$20). These incentives will be based on quarterly weight and all percentage weight loss is calculated based on a participant's initial weight. commencement). Participants receive monthly checks that reflect the percent weight loss.
16137236|NCT01880060|Behavioral|Livin My Weigh|Livin My Weigh is an internet-delivered weight loss program without daily support or financial incentives. Participants receive quarterly newsletters with tips on weight loss, increasing physical activity, and menu suggestions, and optional quarterly educational sessions. Weight is measured in the same manner as the INCENT participants.
16137237|NCT01880047|Drug|Eltrombopag|Eltrombopag will be administered for 8 weeks or until the platelet count exceeds 150,000; at this point dosing will stop, subject will be considered a responder and the subject will eligible for entering Part 2 (the long term treatment part of the study. The dose at which the subject achieved the primary endpoint (> 50,000 and increase by > 20,000) will be considered the dose of response. Dose escalation will continue, despite satisfaction of the primary endpoint of study (> 50,000 and > 20,000 above baseline), unless the platelet count reaches the lower limit of normal range 150,000. Subjects will stop study medication if the platelet count is within the normal range, thereby minimizing any safety risk associated with elevated platelet count.
16137238|NCT01880047|Drug|Placebo|
16137239|NCT01880034|Other|Lipid Emulsion Survey|
16137240|NCT01879969|Procedure|classic procedure of planning|analysis of pictures, 2D radiographs and aesthetics; model surgery and acrylic splint
16137241|NCT01879969|Procedure|computer assisted orthognathic planning and surgery of asymmetric patients|
16137242|NCT01879956|Other|Craft Activities|There is no intervention method used to perform the task.
16137243|NCT01879956|Behavioral|OGI Method|metacognitive approach to assess executive functions.
16137244|NCT01879943|Device|PillCam Colon 2|PillCam® COLON 2 capsule endoscopy is a minimally invasive tool for direct visualization of the colon, including identifying the occurrence of polyps.
16137245|NCT01879943|Procedure|Colonoscopy|Standard colonoscopy is the standard against which capsule endoscopy is compared.
16137246|NCT01879930|Drug|doxycycline|"Zadorin-100® (doxycycline), licence number Swissmedic: 43051 Legal holder: Mepha Pharma AG, Aesch/BL
~Oral intake during study period (4 weeks) once in the morning and once in the evening
~The masking of the agents is conducted using bordeaux-coloured, opaque hard-gelatine capsules (size 00) of the French company LGA. The hard-gelatine capsules are each filled with 1 unit Zadorin® 100"
16137247|NCT01879930|Drug|placebo|"Placebo Galepharm Composition: lactose monohydrate, ceolus PH 102, croscarmellose sodium, magnesiumstearat, manufacturer: Pharmacy Hotz, 8700 Küsnacht, Switzerland
~Oral intake during study period (4 weeks) once in the morning and once in the evening
~The masking of the agents is conducted using bordeaux-coloured, opaque hard-gelatine capsules (size 00) of the French company LGA. The hard-gelatine capsules are each filled with 1 unit placebo 100mg in the sham-group"
16137248|NCT01879917|Drug|Liraglutide|
16137249|NCT01879917|Drug|Placebo|Saline
16137250|NCT01879904|Procedure|Endoscopic submucosal dissection (ESD)|This study is suggest to patients with superficial medium or distal rectal tumors. The lesion was identified and demarcated using white-light endoscopy, magnifying endoscopy, and chromoendoscopy. Then, marking around the lesions was performed. Local injection was made using injection needle, and then mucosal incision was performed around the lesion using endo-knives. Submucosal dissection was performed using endo-knives. Hemostasis and vessel coagulation were practiced using primary hemostatic forceps during the procedure.
16137251|NCT01879891|Other|Aerobic|Exercise training will consist of bicycle ergometer riding starting at 67% of heart rate max for 20 minutes. Exercise Intensity will be progressively increased every week until 80% of heart rate max for 40 minute sessions is reached.
16137252|NCT01879878|Dietary Supplement|Verum, broccoli sprout grain|Patients will be randomly classified into two groups - verum and placebo. The patients in the experimental arm will receive capsules with broccoli sprout grain containing a total of 90mg sulforaphane active substance per day over one year as nutrition supplement whereas patients assigned to the placebo group will receive inactive substance (methylcellulose) with identical capsule and portion distribution.
16137253|NCT01879878|Dietary Supplement|placebo|Patients assigned to the placebo group will receive inactive substance (methylcellulose) with identical capsule and portion distribution as the experimental arm.
16137254|NCT01879865|Other|Non-stimulation|The volunteers will be wearing noise-cancelling headphones (silent) and will be stimulated as little as possible. The volunteer will be instructed to keep his/her eyes closed.
16137255|NCT01879865|Other|Stimulation|The volunteers will be wearing noise-cancelling headphones, through which they will hear a continuous loop of recorded operating room noise (monitor beeps, talking), to simulate operating room conditions. The volunteer will be instructed to keep his/her eyes closed.
16137256|NCT01879852|Behavioral|Quadriceps intensive strengthening|Quadriceps intensive strengthening includes high-intensity neuromuscular electrical stimulation to the quadriceps muscle for 10 minutes and overload to the the eccentric phase of quadriceps strengthening exercises.
16137257|NCT01879852|Behavioral|Standard rehabilitation|Standard rehabilitation will include interventions for typical knee impairments (effusion, knee motion deficits, lower extremity muscle weakness, and gait deviations) as well as advanced rehabilitation interventions as indicated (jump and agility exercises)
16137258|NCT01879839|Dietary Supplement|Diet|Patients receive special diet 4 days prior to contrast-agent administration.
16137259|NCT01879826|Device|Aculaser applied to kidney points|The patient will receive aculaser, performed by licensed acupuncturist, to known kidney acupuncture sites. In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure.
16137260|NCT01879826|Device|Aculaser applied to sham points|"The patient will receive aculaser, performed by licensed acupuncturist, to sham acupuncture sites. In addition, the patient will still receive standard pain control protocols with anesthetic medications like lidocaine plus ketamine or fentanyl and versed during the biopsy, along with pain management after the procedure."
16137261|NCT01879813|Dietary Supplement|Phospholipid drink|Participant in an intervention parallel group will consume a drink with added phospholipids
16137262|NCT01879813|Dietary Supplement|Placebo milk drink|Participant in an intervention parallel group will consume a drink without added phospholipids
16137263|NCT01879800|Behavioral|Acceptance and Commitment Therapy plus Illness Management|
16137264|NCT01879787|Other|tDCS|tDCS involves application of very low-amplitude direct currents(2 mA or less) via surface scalp electrodes.This produces a sub-sensory level of electrical stimulation which remains imperceptible by most people during its application. In a small percentage of patients it may cause minimal discomfort with a mild tingling sensation, which usually disappears after a few seconds. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease corticomotor excitability. Cathodal tDCS decrease and anodal tDCS increase the motor cortex excitability.
16137265|NCT01879774|Other|Neuropsychological and motoric tests|"Neuropsychological tests
~Mini Mental Status Test
~Dem-Tect
~Rey-Osterrieth Complex Figure Test
~Trailmaking Test
~Beck Depression Inventory
~d2-R (optional)
~Motoric tests
~modified UPDRS (Unified Parkinson Disease Rating Scale) Part III
~Timed-up-and-go Test
~Halstead Fingertapping Test
~AIMS (Abnormal involuntary movement scale)
~EEG (only in patients with hyponatremia)
~MRI (only in patients with hyponatremia)"
16137266|NCT01879748|Drug|Rasagiline|"Each subject will be enrolled into 1 of 4 cohorts:
~cohort 1 (16 Japanese subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo
~cohort 2 (16 Caucasian subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo
~cohort 3 (16 Japanese subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo
~cohort 4 (16 Caucasian subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo
~Each subject will then be randomly assigned to 1 of the following groups:
~rasagiline at 0.5 mg (8 Japanese and 8 Caucasian subjects)
~rasagiline at 1 mg (8 Japanese and 8 Caucasian subjects)
~rasagiline at 2 mg (8 Japanese and 8 Caucasian subjects)
~placebo (8 Japanese and 8 Caucasian subjects)"
16137267|NCT01879748|Drug|Placebo|"Each subject will be enrolled into 1 of 4 cohorts:
~cohort 1 (16 Japanese subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo
~cohort 2 (16 Caucasian subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo
~cohort 3 (16 Japanese subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo
~cohort 4 (16 Caucasian subjects): 4 subjects each for 0.5, 1, and 2 mg of rasagiline and placebo
~Each subject will then be randomly assigned to 1 of the following groups:
~rasagiline at 0.5 mg (8 Japanese and 8 Caucasian subjects)
~rasagiline at 1 mg (8 Japanese and 8 Caucasian subjects)
~rasagiline at 2 mg (8 Japanese and 8 Caucasian subjects)
~placebo (8 Japanese and 8 Caucasian subjects)"
16137268|NCT01879735|Drug|11C-CSar|PET/CT recording with bile acid tracer 11C-cholylsarcosine used to evaluate the transport of bile acids.
16137269|NCT01879735|Drug|ICG|Infusion of indocyanine green prior and during the PET/CT scanning with the bile tracer 11C-CSar.
16137270|NCT01879722|Drug|TAK-063|TAK-063 tablets
16137271|NCT01879722|Drug|TAK-063 Placebo|TAK-063 placebo-matching tablets
16137272|NCT01879709|Behavioral|Yoga Training|Participants will be imparted yoga training for twenty-one days, for one hour a day. This will include postures or Asanas (exercises) and Pranayam (Breathing protocols). The training starts with 'Om' chanting followed by warm up exercises and then breathing exercises. The Breathing exercises (Pranayama) are practiced before practice of Asana.
16137273|NCT01879709|Behavioral|Physical Exercise|This group will take part in a general physical exercise program incorporating simple physical exercises for one hour daily, including Saturdays. The schedule will include fifteen minutes of brisk walking followed by light exercises adapted from the National Fitness Corps - Handbook for Middle High and Higher Secondary Schools as used by Duraiswamy et al. (2007).
16137274|NCT01879709|Other|Treatment as Usual|"Placebo Comparator: Treatment as Usual Group
~Participants who will continue in the department with clinical treatment as usual. No supplementation will be provided"
16137275|NCT01879696|Device|ECSPRESS catheter with active vacuum|
16138140|NCT01872910|Drug|Celecoxib|Administered orally
16137276|NCT01879683|Drug|LiRIS® 400 mg|LiRIS® 400 mg is a drug-device combination product which is placed in the bladder during cystoscopy, remains in the bladder for up to 14 days gradually releasing lidocaine, and removed from the bladder via cystoscopy.
16137277|NCT01879670|Device|CircuLite Synergy left ventricular assist device|
16137278|NCT01879657|Drug|68Ga-DOTATATE PET scan|68Ga-DOTATATE will be given in tracer doses and injected intravenously to image Neuroendocrine tumors by Positron Emission Tomography.
16137279|NCT01879644|Behavioral|NF|
16137280|NCT01879644|Behavioral|SM|
16137281|NCT01879644|Behavioral|PE|
16137282|NCT01879644|Behavioral|SU|
16137283|NCT01879631|Procedure|radial keratotomy|
16137284|NCT01879618|Drug|Fragmin|variable dosing regimen
16137285|NCT01879605|Drug|Docusate natrium and sorbitol|
16137286|NCT01879605|Drug|Bisacodyl|
16137287|NCT01879579|Other|Mobile Insulin Titration Intervention|Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.
16137288|NCT01879566|Other|No intervention will be done. The study is observational|
16137289|NCT01879553|Biological|TIV|Trivalent Influenza Virus Vaccine (surface antigen, inactivated, egg-derived)
16137290|NCT01879540|Biological|aTIV|Adjuvanted Trivalent Influenza Virus Vaccine (surface antigen, inactivated, adjuvanted with MF59C.1, egg-derived)
16137291|NCT01879527|Drug|Amiloride hydrochlorothiazide|Blinding will be done by over-encapsulating amiloride HCT tablets and providing corresponding placebo capsules.Patients will be provided with capsules (size 00) containing one tablet of study medication (Amilostad HCT 5/50mg tablet or placebo) and instructed to take these capsules once daily in the morning together with breakfast. Visit 2 will be scheduled one week after baseline and at visit 2 patients will be provided with capsules containing two tablets of study medication. This maintenance dose will not be changed throughout the remaining study period. Placebo will be administered in the exact same manner.
16137292|NCT01879527|Drug|Sugar pill|containing placebo
16137293|NCT01879514|Drug|Chinese Herb Prescription Granule plus prednisone|Chinese Herb Prescription Granule includes ZiBuGanShen Granule and BuShenTongLuo Granule
16137294|NCT01879514|Drug|Placebo|Placebo includes placebo of ZiBuGanShen Granule and placebo of BuShenTongLuo Granule
16137295|NCT01879501|Behavioral|Low Vision Self-Management Program|The program has been describe above.
16137296|NCT01879488|Drug|technetium-99m - Diethylenetriaminepentaacetic acid|
16137297|NCT01879488|Device|Vibrating-mesh nebulizer|
16137298|NCT01879488|Other|Gamma scintigraphy|
16137299|NCT01879488|Other|Preoperative spirometry|
16137300|NCT01879475|Device|032-11|Topical haemostat
16137301|NCT01879475|Device|Floseal (R)|Topical haemostat
16137302|NCT01879462|Drug|GSK2878175|Round tablets (5.0mg) given once daily single and repeated (to 7 days), Oral dose.
16137303|NCT01879462|Drug|Placebo|Visually matching GSK2878175
16137304|NCT01879423|Drug|Lamotrigine Dispersible/Chewable tablets 5mg*5|Single dose of lamotrigine dispersible/chewable 5mg*5 tablets at Day1 and Single dose of Lamotrigine Compressed 25mg*1 tablet at Day15
16137305|NCT01879423|Drug|Lamotrigine Compressed tablet 25mg|Single dose of lamotrigine compressed 25mg*1 tablet at Day1 and Single dose of lamotrigine dispersible/chewable 5mg*5 tablets at Day15
16137306|NCT01879410|Drug|UMEC/VI Inhalation Powder 62.5/25 mcg via NDPI|The drug is administered via NDPI as one inhalation once daily in the morning. NDPI has two strips, each containing 30 blisters of medication. The first strip has UMEC blended with lactose and magnesium stearate in the form of dry white powder with a dosage of 62.5 mcg per blister and the second strip has VI blended with lactose and magnesium stearate in the form of dry white powder with a dosage of 25 mcg per blister.
16137307|NCT01879410|Drug|FSC Inhalation Powder 250/50 mcg via ACCUHALER/DISKUS|The drug is administered via ACCUHALER/DISKUS inhaler as one inhalation each morning and evening. The inhaler contains a single strip with 60 blisters of medication. The strip has 250 mcg of fluticasone propionate and 50 mcg of salmeterol per blister in the form of dry white powder.
16137308|NCT01879410|Drug|Placebo DISKUS|Placebo is administered via ACCUHALER/DISKUS inhaler as one inhalation each morning and evening. The inhaler contains 1 strip with 60 blisters of placebo in the form of dry white powder.
16137309|NCT01879410|Drug|Placebo NDPI|Placebo is administered via NDPI as one inhalation once daily in the morning. The inhaler contains 2 strips with 30 blisters of placebo per strip in the form of dry white powder.
16137310|NCT01879397|Device|Research Ultrasound Exam|"Collection of backscattered ultrasound data during non-invasive ultrasound exam
~ARFI based images of the carotid artery and plaque
~Ultrasound signals received by the ultrasound imaging system are recorded. These signals are discarded during the image formation process for a standard duplex ultrasound exam."
16137311|NCT01879384|Device|CMA 70 catheter directly positioned in bone tissue|At the end of the surgery the CMA microdialysis catheter is placed inside the bone
16137312|NCT01879371|Drug|Ibuprofen+caffeine FDC|oral dose
16137313|NCT01879371|Drug|Ibuprofen (Nurofen Immedia®)|oral dose
16137314|NCT01879371|Drug|Ibuprofen (Brufen®)|oral dose
16137315|NCT01879358|Device|Drug-eluting stent|
16137316|NCT01879345|Drug|BIA 2-093 - 1800 mg (Group 1)|3 tablets of BIA 2-093
16137317|NCT01879345|Drug|BIA 2-093 - 2400 mg (Group 2)|4 tablets of BIA 2-093 600 mg
16137318|NCT01879345|Drug|Placebo|placebo tablets
16137319|NCT01879332|Drug|Placebo|Matching placebo tablets for oral administration
16137320|NCT01879332|Drug|BIA 2-093 3000 mg once daily|Eslicarbazepine acetate 600 mg tablets for oral administration
16137321|NCT01879332|Drug|BIA 2-093 3600 mg once daily|Eslicarbazepine acetate 600 mg tablets for oral administration
16137322|NCT01879319|Biological|Evolocumab AMD|Evolocumab subcutaneous injection using a single use, disposable AMD containing 3.5 mL deliverable volume.
16137323|NCT01879319|Biological|Evolocumab AI/pen|Evolocumab subcutaneous injection using a handheld mechanical (spring-based) prefilled AI/Pen, each containing 1.0 mL deliverable volume.
16137324|NCT01879293|Drug|Metformin|
16137325|NCT01879293|Drug|placebo|
16137625|NCT01876849|Drug|exenatide|subcutaneous injection, 5mcg or 10 mcg, twice daily
16137626|NCT01876836|Device|i-gel|i-gel placed after induction
16137326|NCT01879280|Procedure|Traditional pterional craniotomy|In the standard pterional craniotomy group, the attachment of the temporalis will be cut and the temporalis will be mobilized prior to exposure of the underlying bony calvarium. This maneuver is currently accepted for use by the majority of neurosurgeons nationwide.
16137327|NCT01879280|Procedure|Osteoplastic craniotomy|"In the osteoplastic group, the temporalis will be left attached to the bony calvarium prior to exposure of the tumor. There are ways to turn a bone flap with the temporalis still attached (i.e., an osteoplastic craniotomy). However, this method is thought to be slightly more time-consuming and is used less often in many centers. Aside from the extra time involved, we do not feel that leaving the temporalis attached to the bony calvarium disadvantages the patient in any fashion and may--in fact--result in less post-operative morbidity."
16137328|NCT01879267|Behavioral|Exercise training|6 months of exercise training (2 times 30 min per week) starting one week after a 6-months natural course observation period
16137329|NCT01879254|Device|Deep Brain Stimulation|
16137330|NCT01879241|Drug|Rasagiline|
16137331|NCT01879241|Drug|Placebo|a sugar pill manufactured to mimic Rasagiline 1 mg tablet
16137332|NCT01879228|Drug|Sitagliptin|The GPA test as described in the primary outcome section will be performed at baseline and after 6 months of therapy in the Sitagliptin and placebo arms. Furthermore, evaluation of endogenous GLP-1 levels will be assessed by a mixed meal tolerance test compared at baseline and 6 months.
16137333|NCT01879215|Procedure|Intramedullary nailing of the tibia|Standard care surgery
16137334|NCT01879202|Drug|Methylphenidate modified release|Ritalin 20mg once daily within the first week, Ritalin 30mg once daily within the second week and afterwards Ritalin 40mg will be taken once daily throughout the remaining active treatment phase.
16137335|NCT01879202|Drug|Maltodextrin|Study medication will be taken once daily. Patients will take 20mg of study medication within the first week, 30mg within the second week and afterwards 40mg of study medication throughout the remaining active study period.
16137336|NCT01879189|Behavioral|Breast Cancer Screening Decision Aid|The intervention will include access to the personal decision aid tool for patients in the intervention arm of the study, determined by the randomized physician schedule and the patient's appointment time.
16137337|NCT01879176|Device|CytoSorb|
16137338|NCT01879163|Biological|MVA85A-IMX313|Intradermal injection of MVA85A-IMX313 (MVA85A-IMX313 combines the candidate TB vaccine MVA85A with the carrier protein IMX313)
16137339|NCT01879163|Biological|MVA85A|Intradermal injection of MVA85A (recombinant Modified Vaccinia virus Ankara expressing the M. tb antigen 85A)
16137340|NCT01879150|Device|Cyclaplex bone anchor|Device implantation
16137341|NCT01879111|Other|patient-targeted feedback|Using a randomised-controlled study design half of the patients will receive a patient-targeted written screening feedback. This feedback contains information about depression in general, depression-severity adapted treatment guidelines and contact-information for treatment.
16137342|NCT01879098|Dietary Supplement|Probiotic: Bacillus subtilis|Bacillus subtilis will be taken as a capsule once daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
16137343|NCT01879098|Dietary Supplement|Lactobacillus plantarum|Lactobacillus plantarum will be taken as a capsule once daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
16137344|NCT01879098|Dietary Supplement|Bifidobacterium animalis|Bifidobacterium animalis will be taken as a capsule once daily for 6 weeks by subjects in the group receiving this supplement (group is unknown, double-blinded).
16137345|NCT01879098|Dietary Supplement|Placebo|Placebo will be taken once daily for 6 weeks by every subject at some point in the study (crossover design).
16137346|NCT01879085|Drug|Docetaxel|75 mg/m2 IV over 60 minutes on day 8 every 21 days (1 cycle).
16137347|NCT01879085|Drug|Gemcitabine|given on days 1 and 8 at 900 mg/m2 IV over 90 minutes (fixed dose infusion rate at 10 mg/m2/min) every 21 days (1 cycle). For dose level -2, Gem will be given over 67.5 minutes at 10 mg/m2/min.
16137348|NCT01879085|Drug|Vorinostat|will be given orally at the specified dose levels (Table 2) on days -1 to +2 and days +7-9 every 21 days (treatment for 3 days starting one day prior to chemotherapy on every cycle).
16137349|NCT01879085|Drug|Pegfilgrastim|Administered on day 9 subcutaneously at 6 mg.
16137350|NCT01879059|Behavioral|Exercise|short period of inactivity (5 days) followed by a return to physical activity (1 day)
16137351|NCT01879046|Procedure|arthroplasty|Blood, bone marrow, synovial fluid and Hoffa's fat pad samplings
16137352|NCT01879033|Other|Reactive hyperemia peripheral artery tonometry (Rh-PAT)|Pulse volume is measured by a finger plethysmographic device which are sensed by a pressure transducer and transferred to a computer where the signal is amplified, displayed and stored (EndoPAT, Itamar Medical). Fingertip probes are placed on the index finger of both hands and 5 minutes of baseline recording are obtained. Blood flow is then occluded in one arm for 5 minutes, using a standard blood pressure cuff. Recording continues in both fingers during occlusion and for 5 minutes after release of the cuff. The RH-PAT index is calculated as the ratio of the average pulse amplitude in the post-hyperemic phase divided by the average baseline amplitude, with normalization to the signal in the control arm to compensate for any systemic changes.
16137353|NCT01879033|Other|Blood levels for glucose, insulin, lipids and adipocytokines|A fasting laboratory evaluation will include chemistry panel (basic metabolic, liver function tests), CBC, lipid profile, urinalysis and HbA1c. All obese recruited subjects after a 12 hour fast will undergo an OGTT using a glucose load of 1.75 g/kg body weight with a maximum of 75 g. Blood samples will be collected for insulin, glucose, leptin, adiponectin, hsCRP and FFA. Serum and urine will be stored at -70 degrees Centigrade for measuring markers of oxidative stress and adipocytokines (including TNF-α, PAI-1)
16137354|NCT01879020|Drug|TA-8995|Drug: TA-8995 1mg
16137355|NCT01879020|Drug|TA-8995|Drug: TA-8995 2.5mg
16137356|NCT01879020|Drug|TA-8995|Drug: TA-8995 5mg
16137357|NCT01879020|Drug|TA-8995|Drug: TA-8995 10mg
16137358|NCT01879020|Drug|TA-8995|Drug: TA-8995 25mg
16137359|NCT01879020|Drug|Placebo|Placebo (TA-8995 1mg)
16137360|NCT01879020|Drug|Placebo|Placebo (TA-8995 2.5mg)
16137361|NCT01879020|Drug|Placebo|Placebo (TA-8995 5mg)
16137362|NCT01879020|Drug|Placebo|Placebo (TA-8995 10mg)
16137363|NCT01879020|Drug|Placebo|Placebo (TA-8995 25mg)
16137364|NCT01879007|Drug|Factive® Tab / Factive IV|
16137365|NCT01878994|Behavioral|Counselling group|
16137367|NCT01878968|Other|Script and CPR/Mechanical ventilation video.|Patients will be randomized to receive the script (see addendum) plus video. Video was produced by and is the property of the study investigators.
16137368|NCT01878955|Genetic|AMH level difference between patient with PCOS and multicystic ovaries.|
16137369|NCT01878942|Drug|Placebo|"Capsules containing mannitol looking identical to LSD
~per os"
16137370|NCT01878942|Drug|LSD|200µg per os, single dose
16137371|NCT01878929|Drug|Allergen(Tree, Grass, Weeds)|Greer is manufacture of all allergen extract used in this study.
16137372|NCT01878903|Other|Electronic VAS|Post-opearive pain patients will be assessed using electional VAS and verbal NRS
16137373|NCT01878890|Drug|Efavirenz 600mg|Efavirenz 600 mg (oral daily intake)
16137374|NCT01878890|Drug|Efavirenz 1200 mg|Efavirenz 1200mg (oral daily intake)
16137375|NCT01878890|Drug|Efavirenz 1800 mg|Efavirenz 1800mg (oral daily intake)
16137376|NCT01878890|Drug|Efavirenz 2200 mg|Efavirenz 2200mg (oral daily intake)
16137377|NCT01878864|Drug|Bupivacaine lozenge|
16137378|NCT01878864|Drug|Lidocaine-adrenalin injection|
16137379|NCT01878838|Procedure|Femtosecond Laser Assisted Cataract Surgery w/ Catalys Laser|Cohort subjects will undergo Femtosecond Laser Assisted Cataract Surgery in both eyes, with the Optimedica Catalys laser on one eye, and the Alcon LensX laser on the other. First eyes will be randomized.
16137380|NCT01878838|Procedure|Femtosecond Laser Assisted Cataract Surgery w/ LenSx Laser|Cohort subjects will undergo Femtosecond Laser Assisted Cataract Surgery in both eyes, with the Optimedica Catalys laser on one eye, and the Alcon LensX laser on the other. First eyes will be randomized.
16137381|NCT01878825|Biological|Fluviral™|1 dose administered intramuscularly in deltoid region of non-dominant arm.
16137382|NCT01878812|Biological|Fluarix/Influsplit Tetra® (2013-2014 season)|1 dose administered intramuscularly in the deltoid region of non-dominant arm
16137383|NCT01878799|Drug|GS-7977/GS- 5885 FDC|The GS-7977/GS-5885 FDC product combines a potent HCV nucleotide inhibitor and a potent HCV NS5A inhibitor and will be given for 12 weeks.
16137384|NCT01878786|Drug|Everolimus|One of the immunosuppressants currently being evaluated to replace CNIs in patients with CNI nephropathy is the mammalian Target of Rapamycin (mTOR) inhibitor, Sirolimus. Everolimus is a derivative of Sirolimus and belongs to this class of immunosuppressants, therefore, both drugs have similar side effect profile. The half-life of Everolimus is almost half of Sirolimus (Everolimus 30 hours vs Sirolimus 62 hours), which makes its dose adjustment easier although it would require more frequent dosing. In clinical trials, Everolimus has demonstrated its potential role as a safe alternative in minimizing and/or eliminating CNI such as Cyclosporin A and Tacrolimus .
16137385|NCT01878786|Drug|Tacrolimus|One of the immunosuppressants currently being evaluated to replace CNIs in patients with CNI nephropathy is the mammalian Target of Rapamycin (mTOR) inhibitor, Sirolimus. Everolimus is a derivative of Sirolimus and belongs to this class of immunosuppressants, therefore, both drugs have similar side effect profile. The half-life of Everolimus is almost half of Sirolimus (Everolimus 30 hours vs Sirolimus 62 hours), which makes its dose adjustment easier although it would require more frequent dosing. In clinical trials, Everolimus has demonstrated its potential role as a safe alternative in minimizing and/or eliminating CNI such as Cyclosporin A and Tacrolimus.
16137386|NCT01878786|Drug|Mycophenolate mofetil (MMF/MPA)|Control Drug
16137387|NCT01878773|Other|High Quality Volume CT Scan; MRI Scan|"Patients will have the High Quality volume CT scan immediately after their CT scan followed by MRI scan.
~--------------------------------------------------------------------------------"
16137388|NCT01878747|Behavioral|Provider Tailored Intervention for Perioperative Stress|Provider Tailored Intervention for Perioperative Stress (P-TIPS) is developed based on the proximal-distal theory that suggested that in acute procedural settings specific adult behaviors directly affect children's distress and coping behaviors. P-TIPS aims at reducing preoperative anxiety in children via modifying adults' behavior.
16137389|NCT01878734|Dietary Supplement|Micronutrient Powders|Mothers will receive a one box containing 30 sachets of Micronutrient Powders (MNP) every other month. MNP will be procured offshore with support from UNICEF Supply Division in Copenhagen, which maintains a list of approved MNP suppliers and ensures compliance with standard requirements and product specifications. For this study MNP will be purchased from Piramal Healthcare Ltd, India.
16137391|NCT01878708|Drug|PEG-L-asparaginase|
16137392|NCT01878708|Drug|Dexamethasone acetate|-dexamethasone 40mg daily for 4 days with every cycle.
16137393|NCT01878695|Drug|IV/oral n-acetylcysteine|
16137394|NCT01878669|Drug|N-acetyl cysteine|
16137395|NCT01878669|Drug|Saline|
16137396|NCT01878656|Drug|Sevoflurane|The investigators decrease to 1 minimal alveolar concentration(MAC) of anesthetic combination of sevoflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, sevoflurane and nitrous oxide are discontinued.
16137397|NCT01878656|Drug|Desflurane|The investigators decrease to 1 MAC of anesthetic combination of desflurane and nitrous oxide, and maintain end-tidal concentration of anesthetic combination at 1 MAC until the end of surgery. At the end of surgery, desflurane and nitrous oxide are discontinued.
16137398|NCT01878643|Drug|vancomycin or gentamicin|Choice of antibiotic is determined by Gram stain of sputum.The antibiotic is administered via nebulization through the ventilator circuit every 8 hours
16137399|NCT01878643|Drug|Placebo|normal saline administered to patient via nebulization
16137400|NCT01878630|Device|Remote Patient Management|"Guideline-based care in heart failure including at least 5 scheduled doctor's visits within 12 months (GP and specialist) plus devices for Remote Patient Management at patient site for daily monitoring of ECG, weight, blood pressure, self-report of health status:
~weighing scale (Seca 861 with bluetooth, seca gmbh & co. kg.)
~blood pressure device (UA767PBT with bluetooth, A&D Ltd.)
~ECG-eventrecorder (PhysioMem® PM 1000, getemed Medizin- und Informationstechnik AG)
~patient-communication platform (Physio-Gate® PG 1000, getemed Medizin- und Informationstechnik AG)
~help call device (DORO Easy 510/ Doro HandlePlus 334gsm, doro AB)
~at center site:
~- electronic patient record (eHealth connect 2.0, T-Systems International)"
16137401|NCT01878630|Other|Usual Care|Guideline-based care in heart failure including at least 5 scheduled doctor's visits within 12 months (GP and specialist)
16137627|NCT01876836|Device|C-LMA|placed after induction
16137402|NCT01878617|Radiation|Craniospinal Irradiation with boost to the primary tumor site|All participants will undergo craniospinal irradiation (CSI) with boost to the primary tumor site. The dose given is based on the molecular and risk group as noted in the arm descriptions. The type of radiation used includes conformal radiation therapy (photons) or intensity modulated radiation therapy (IMRT) or proton beam therapy.
16137403|NCT01878617|Drug|Cyclophosphamide|Route of Administration (ROA): Intravenously (IV)
16137404|NCT01878617|Drug|Cisplatin|ROA: IV
16137405|NCT01878617|Drug|Vincristine|ROA: IV
16137406|NCT01878617|Drug|Vismodegib|ROA: Orally (PO)
16137407|NCT01878617|Drug|Pemetrexed|ROA: IV
16137408|NCT01878617|Drug|Gemcitabine|ROA: IV
16137409|NCT01878617|Other|Aerobic Training|
16137410|NCT01878617|Other|Neurocognitive Remediation|
16137411|NCT01878604|Genetic|Gene analysis|Gene analysis
16137412|NCT01878604|Other|Historical data of lipid-lowering drug administration|Collecting historical data of lipid-lowering drug administration
16137413|NCT01878604|Other|Historical data of plasma lipids, xanthoma changes|Collecting historical data of plasma lipids and xanthoma changes
16137414|NCT01878578|Drug|Eslicarbazepine acetate|Tablets containing ESL 600 mg
16137415|NCT01878578|Drug|phenytoin|Hidantina® tablets containing 100 mg of phenytoin
16137416|NCT01878578|Drug|Placebo|Tablets containing matching placebo
16137417|NCT01878565|Drug|Drug|Given four times in week 0, 4, 12 and 24. At each time of treatment, the patients will be hospitalized and treated with 800 unit of HBIG intramuscularly at day 0, 1, 2, 3 and 4, then were treated with 75 μg of GM-CSF subcutaneously at day 2, 3, 4, 5 and 6, and finally were injected 20 μg of HBV vaccine subcutaneously at day 6.
16137418|NCT01878565|Drug|GM-CSF control|Given four times in week 0, 4, 12 and 24. At each time of treatment, the patients will be hospitalized and treated with saline placebo intramuscularly or subcutaneously at day 2, 3, 4, 5, 6.
16137419|NCT01878539|Device|coagulometer|
16137420|NCT01878539|Behavioral|training programme|
16137421|NCT01878526|Drug|Alginic acid|Algycon 1 tab chew tid after meal
16137422|NCT01878526|Drug|placebo (for domperidone)|placebo (for domperidone) 1 tab oral tid before meal
16137423|NCT01878526|Drug|Domperidone|domperidone (10 mg) 1 tab oral tid before meal
16137424|NCT01878526|Drug|placebo (of alginic acid)|placebo (for alginic acid) 1 tab chew tid after meal
16137425|NCT01878513|Drug|risperidone|3 levels of dosing dependent on which condition a patient is assigned to.
16137426|NCT01878500|Device|Intraoperative stereotactic imaging with VectorVision|Surgeon will use intraoperative stereotactic imaging with VectorVision® Cranial Guided Image System by Brainlab Inc. to assist in bladder exstrophy closure. Prior to the operation a team consisting of pediatric urologist, pediatric radiologists, and a VectorVision rep will use pre-operative MRI to map out specific bony and muscular structures of the pelvic floor. Doing so will allow the pediatric urologist to use these markers intraoperatively to help guide his closure and also allow for future surgeons who use this technology to understand the correct planes to develop for the same surgery.
16137427|NCT01878487|Device|Thrombus aspiration (Intravascular Ultrasound catheter (Boston))|"There is a single arm in the study where all patients are undergoing primary percutaneous coronary intervention for an acute myocardial infarction.
~All patients will have an Intravascular Ultrasound three times:
~At baseline
~After thrombus aspiration with a thrombus extraction catheter
~After stent deployment
~We are however assessing the physiological response of patients having an acute myocardial infarction and this is not a test of the devices as such."
16137428|NCT01878474|Drug|TA-8995|TA-8905 5, 10, 25, 50 (fasted and fed), 100 and 150 mg
16137429|NCT01878474|Drug|TA-8995|Drug: TA-8995 25 mg
16137430|NCT01878474|Drug|TA-8995|Drug: TA-8995 25 mg
16137431|NCT01878474|Drug|TA-8995|Drug: TA-8995 25, 50, 100 and 150 mg
16137432|NCT01878474|Drug|Placebo|Single ascending dose in Caucasian men
16137433|NCT01878474|Drug|Placebo|Age-effect in Caucasian men
16137434|NCT01878474|Drug|Placebo|Gender-effect in Caucasian women
16137435|NCT01878474|Drug|Placebo|Single ascending dose in Japanese men
16137436|NCT01878461|Drug|Vehicle|
16137437|NCT01878461|Drug|M518101|
16137438|NCT01878448|Drug|Anlotinib|
16137439|NCT01878435|Other|SMS reminder|
16137440|NCT01878435|Other|Travel subsidy|
16137441|NCT01878435|Other|Travel subsidy 2|
16137442|NCT01878422|Drug|Arm A: FOLFIRI or FOLFOX + Bevacizumab|Arm A: FOLFIRI or FOLFOX + Bevacizumab or Arm E: FOLFIRI or FOLFOX plus BEVACIZUMAB
16137443|NCT01878422|Drug|Arm B: FOLFIRI or FOLFOX|Arm B: FOLFIRI or FOLFOX or Arm C: FOLFIRI or FOLFOX
16137444|NCT01878422|Drug|Arm D: FOLFIRI or FOLFOX plus CETUXIMAB|Arm D: FOLFIRI or FOLFOX plus CETUXIMAB
16137445|NCT01878422|Drug|Arm F: FOLFIRI or FOLFOX plus BEVACIZUMAB and CETUXIMAB|Arm F: FOLFIRI or FOLFOX plus BEVACIZUMAB and CETUXIMAB
16137446|NCT01878396|Drug|Anti-B-RAF|
16137447|NCT01878383|Device|Genexpert assay|
16137448|NCT01878370|Other|High risk|"Aggregate-level feedback reports focusing on the proportion of patients with hypertension and/or diabetes and/or ischemic heart disease meeting criteria for high-risk sent via courier every six months and available on a password protected website. Family physicians in this arm will also have access through this website to a list of chart numbers identifying those patients at highest risk.
~Family physicians in Arm 2 are asked to complete a worksheet that also includes goal setting and action planning, but focuses on reducing the number of patients with high-risk criteria and offers some suggested practice-based approaches."
16137449|NCT01878370|Other|Best Practice|"Standard, aggregate-level feedback reports focusing on the proportion of patients with hypertension and/or diabetes and/or ischemic heart disease meeting targets sent via courier every six months and available on a password protected website. Family physicians in this arm will also have access through this website to patient-level data to identify patients not achieving optimal quality of care targets.
~Family physicians in Arm 1 are asked to complete a worksheet that follows continuous quality improvement principles, including setting an aim statement, engagement with team members in the clinic, testing change concepts at first on a small scale, and then scaling up in a effort to spread best practices."
16137529|NCT01877668|Drug|Placebo|Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 2 tablets (5 mg) BID x 9 months Placebo injections every 2 weeks x 12 months
16137450|NCT01878357|Drug|dihydroartemisinin-piperaquine|Treatment will be given to all malaria-positive individuals on microscopic examination. The dosage will be calculated based on body weight. The drug that will be given is 3-day dihydroartemisinin-piperaquine (DHP) treatment. The drug will be given by health care personnel at their houses assisted by health care volunteers of the integrated health post (Posyandu cadre).
16137451|NCT01878357|Drug|primaquine|One day primaquine (PQ) treatment will be given for P. falciparum infected subjects. For patients who are infected by P. vivax and P. ovale,PQ will be given for 14 days
16137452|NCT01878344|Drug|NAC|
16137453|NCT01878344|Drug|Saline|
16137454|NCT01878318|Drug|methotrexate|stable dose
16137455|NCT01878318|Drug|tocilizumab [RoActemra/Actemra]|8 mg/kg intravenously every 4 weeks, 24 weeks
16137456|NCT01878305|Device|Molecular Adsorbent Recirculating System (MARS)|MARS is an extracorporeal albumin dialysis device, used in the treatment of liver failure patients to stabilize the patient and halt the progression of HE, giving the liver time to recover in some cases and allowing additional time before liver transplantation in others.
16137457|NCT01878292|Drug|Placebo|Dose matched placebo tablets, once per day, oral administration.
16137458|NCT01878292|Drug|Vilazodone|Vilazodone tablets, 15 mg per day, oral administration
16137459|NCT01878292|Drug|Vilazodone|Vilazodone tablets, 30 mg once per day, oral administration
16137460|NCT01878279|Other|Underlying medical illness|
16137461|NCT01878266|Radiation|Hypofractionated Arm (1)|A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week
16137462|NCT01878266|Radiation|Hypofractionated Arm (2)|The total dose to 4500 cGy in 15 fractions in 3 weeks
16137463|NCT01878266|Radiation|Conventional Arm (3)|A total dose of 54 Gy in 30 fractions giving 1.8 Gy per fraction.Conventional arm
16137464|NCT01878253|Device|Sidus Stem-Free Total Shoulder Arthroplasty System|
16137465|NCT01878240|Procedure|EVAR without coils embolization/ Coils embolization during EVAR|
16137466|NCT01878227|Drug|Coenzyme A|Coenzyme A 400mg per day
16137467|NCT01878227|Drug|Fenofibrate 200mg|Fenofibrate 200mg per day
16137468|NCT01878214|Behavioral|Targeted messaging|6 targeted mailed messages and 6 booster text messages
16137469|NCT01878214|Behavioral|Standard messaging|1 informational letter
16137470|NCT01878201|Drug|Fimasartan|Fimasartan 30 mg
16137471|NCT01878201|Drug|Valsartan|Valsartan 80 mg
16137472|NCT01878188|Drug|BC-819/PEI|Intravesical instillation
16137473|NCT01878188|Drug|BCG Vaccine|intravesical instillations
16137474|NCT01878175|Behavioral|Functional Movement Retraining|15-week rehabilitation / exercise intervention, including visits at the Durham VA medical center, in-home with clinical personnel, and via telephone. The intervention is tailored to participants' post-operative functional status, particularly unilateral balance asymmetries. The exercise program will focus on three areas: lower extremity mobility (ankle, knee and hip), muscle stability (quadriceps and gluteal muscle strength) and functional movement patterns (lower extremity focus). Participants will be instructed to perform their prescribed stretching exercises daily and strengthening exercises three times per week (on non-consecutive days).
16137475|NCT01878162|Other|Exercise|
16137476|NCT01878136|Drug|Tissue Plasminogen Activator|Dose: 1mg Q8 x 12 doses, or until clearance of blood from ventricles and cisterns Administration: intraventricular administration (through external ventricular drain)
16137477|NCT01878123|Biological|AMP-110|Dose levels 1 through 7: Single intravenous infusion on Day 0
16137478|NCT01878123|Other|Placebo|Dose levels 4 through 7: Single intravenous infusion on Day 0
16137479|NCT01878110|Behavioral|COMB|
16137480|NCT01878097|Behavioral|Green Dot Bystander Intevention|Intervention allocated at the school level
16137481|NCT01878097|Behavioral|Control|Awareness Education
16137482|NCT01878084|Other|bioactive glass (sol-gel)|Extraction sockets will be augmented using bioactive glass (sol-gel)
16137483|NCT01878084|Other|empty extraction socket|Extraction socket will be left empty
16137484|NCT01878058|Other|MRI Scan|Patient will receive an additional MRI scan in addition to their standard of care imaging
16137485|NCT01878006|Drug|Morphine|
16137486|NCT01878006|Drug|Placebo|
16137487|NCT01877967|Dietary Supplement|VSL#3|The intervention group will be asked to ingest two sachets (2x4.4g) of the food supplement (VSL#3) each day for 12 weeks, either both at the same time, or one in the morning and one in the evening. This food supplement is in powder form and can be ingested with either cold food or any non-carbonated cold drink. The control group will be given a placebo, although as it is a double-blind intervention, will not know it is a placebo. They will similarly to the intervention group be asked to take two sachets (2x4.4g) of a powder rach day for 12 weeks, either both at the same time, or one in the morning and one in the evening.
16137488|NCT01877967|Dietary Supplement|placebo|
16137489|NCT01877954|Drug|Extra-fine hydrofluoroalkane beclometasone dipropionate|
16137490|NCT01877954|Drug|Fluticasone propionate|
16137491|NCT01877941|Device|Pulmonary Artery Catheter (PAC)|A catheter is inserted into the pulmonary artery, through the internal jugular vein; cardiac output is indicated by the speed that a temperature gradient dissipates.
16137492|NCT01877941|Device|Endotracheal Cardiac Output Monitor (ECOM)|An FDA-approved medical device is inserted into the patient's throat; cardiac output is calculated by measuring how electricity moves through the chest.
16137493|NCT01877941|Device|Estimated Continuous Cardiac Output (esCCO)|Sensors are placed on the arm, finger and leg to calculate Pulse Wave Transit Time (PWTT); the time it takes for the pulse of the heartbeat to travel through the body.
16137494|NCT01877928|Device|Boussignac CPAP device|Is a continuous positive airway pressure (CPAP) system marketed in Canada and the US for the treatment of Obstructive Sleep Apnea. The main difference is that this system is portable wheres the standard hospital CPAP is not. This allows for the application immediately post-extubation.
16137495|NCT01877928|Device|standard CPAP|Standard of care postoperative treatment for OSA.
16137532|NCT01877642|Drug|Lorazepam 1 mg IM|Lorazepam 1 mg intramuscular
16137533|NCT01877642|Drug|Inhaled loxapine 10 mg|Inhaled Staccato loxapine 10 mg
16139619|NCT01861600|Other|Human Milk|Human Milk
16137496|NCT01877915|Drug|Rivaroxaban|Each participant, randomly allocated to the rivaroxaban arm, will receive one 2.5 mg tablet of rivaroxaban orally (by mouth) twice daily (once in the morning and once in the evening at approximately the same time each day) until the global treatment end date (GTED) (defined as the date when 1200 primary efficacy outcome events have occurred). Rivaroxaban will be given with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
16137497|NCT01877915|Drug|Placebo|Each participant, randomly allocated to the placebo arm, will receive one matching placebo tablet orally twice daily (once in the morning and once in the evening at approximately the same time each day) until the GTED. Placebo will be given with standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician).
16137498|NCT01877915|Other|Standard of care for heart failure and coronary artery disease|Each participant's standard of care for heart failure and coronary artery disease (as prescribed by the participant's managing physician) should be continued throughout the study.
16137499|NCT01877889|Drug|Canagliflozin|One 300 mg over-encapsulated tablet taken orally (by mouth) once daily for 4 days during Part 1 and Part 2 (Sequence 1 [treatment period 2] or Sequence 2 [treatment period 1]).
16137500|NCT01877889|Drug|Dapagliflozin|One 10 mg over-encapsulated tablet taken orally once daily for 4 days during Part 2 (Sequence 1 [treatment period 1] or Sequence 2 [treatment period 2]).
16137501|NCT01877863|Other|exercise|12 weeks of intradialytic biking at Borg intensity 3 - 4 for 15 to 60 minutes on each dialysis run
16137502|NCT01877850|Procedure|weaning protocol|"Reduction of pressure support ventilation (PSV) by 2cmH2O at a time to a maximum of 4cmH2O per day.
~When a patient was able to tolerate PSV less than 8 cmH2O for at least 120 minutes, the nurses started to reduce End Expiratory Positive Pressure (PEEP) by 2cmH2O at a time to a maximum of 4cmH2O per day.
~When a patient was able to tolerate PSV less than 8 cmH2O with PEEP less than 6 cmH2O, the nurses started SBT trial: Continuos Positive Pressure Airways of 6cmH2O for at least 120 minutes and following discontinuation from ventilator."
16137503|NCT01877837|Drug|Alemtuzumab|"Adjusted Ideal Body Weight Formula: AIBW = IBW + [(0.4) x (ABW - IBW)]
~b) Medications
~i.) Alemtuzumab I. Hb S% must be < or = 45% within 7 days prior to initiation of Alemtuzumab II. Iron chelation and hydroxyurea must be discontinued >48 hours before initiating therapy III. Alemtuzumab will be diluted in 100mL of 0.9% NS and infused at a rate as below"
16137504|NCT01877837|Drug|Fludarabine|I. Fludarabine should be diluted in 100 ml 0.9%NS and given over 30 minutes. II. A daily dose of an antiemetic should be given 30 minutes prior to administration of the Fludarabine
16137505|NCT01877837|Drug|Melphalan|"I. Melphalan should be diluted in 0.9%NS to a concentration of 0.1 -0.45 mg/mL and given over 45 minutes. *Entire dose must be infused within 60 minutes of reconstitution in Pharmacy.
~II. A daily dose of an antiemetic should be given 30 minutes prior to administration of the Melphalan III. Patients should be encouraged to suck on a popsicle or something similar during the Melphalan infusion."
16137506|NCT01877837|Procedure|Stem Cells|Infusion of Hematopoietic Stem Cells
16137507|NCT01877824|Other|Fast-track training|
16137508|NCT01877811|Drug|RXDX-105|"During Phase 1/1b, subjects will receive daily oral doses of RXDX-105 in 28-day cycles (except for Day 2 of Cycle 1). To determine the recommended Phase 2 dose (RP2D), doses will be administered in an escalated fashion starting at 20 mg/day.
~During Phase 1b, subjects will be administered the RP2D in 28-day treatment cycles until documented radiographic progression, unacceptable toxicity, withdrawal of consent, or protocol specified parameters to stop treatment."
16137509|NCT01877798|Procedure|volume resuscitation, vasoactive drug|
16137510|NCT01877785|Drug|MHAA4549A|Single-ascending dose of MHAA4549A
16137511|NCT01877785|Drug|Placebo|Placebo to MHAA4549A
16137512|NCT01877772|Procedure|Bone Trephination|For the bone trephination, the wire will be advanced into the insertion site through the cortex and into the metaphyseal bone of proximal humerus.
16137513|NCT01877772|Procedure|Control|The control group will undergo standard rotator cuff repair.
16137514|NCT01877759|Biological|Mesenchymal stem cell|Intravenous dose of Mesenchymal stem cell derived from human Bone Marrow & umbilical cord , IN 6 divided doses , at interval of 1 week .
16137515|NCT01877746|Drug|Combination of prednisone and azathioprine|"Prednisone for a total of 90 days, with initial dose 1mg/kg/day p.o., given for 12 days and then tapered every 5 days for 5mg/day to the maintenance dose of 0.2mg/kg/day. The daily dose of Prednisone will be rounded to the nearest value divisible by 5.
~Azathioprine for 100 days in total, with dose 1 mg/kg/day. The daily dose of Azathioprine will be rounded to the nearest value divisible by 25."
16137516|NCT01877746|Drug|Combination of prednisone and azathioprine|"Prednisone for a total of 6 months, with initial dose 1mg/kg/day p.o. given for 4 weeks with a subsequent maintenance dose of 0,33 mg/kg/den. The daily dose of Prednisone will be rounded to the nearest value divisible by 5.
~Azathioprine for 6 months in total, with dose 2mg/kg/day. The daily dose of Azathioprine will be rounded to the nearest value divisible by 25."
16137517|NCT01877746|Other|No intervention|No intervention, only standard medical therapy
16137518|NCT01877733|Other|Maximal strength training|
16137519|NCT01877720|Device|noninvasive respiratory support with NAVA mode and PSV|
16137520|NCT01877707|Other|home monitoring|Record daily - peak flow measurements, pulse rate, oxygen saturation levels, weight,activity and daily sputum samples.
16137521|NCT01877694|Drug|Auriclosene Solution 0.3%|Ophthalmic solution dispensed as drops onto the eye
16137522|NCT01877694|Drug|Auriclosene Vehicle|Ophthalmic Vehicle solution dispensed as drops onto the eye
16137523|NCT01877681|Procedure|Tele-assistance|Assisted care (Tele-assistance) provided by an expert nurse through a informatic online application
16137524|NCT01877681|Procedure|Active comparator|Usual care as specified in the PU practice guideline
16137525|NCT01877668|Drug|Tofacitinib 5 mg BID|Tofacitinib orally (po) 1 tablet of 5 mg and placebo po 1 tablet BID x 12 months Placebo injections subcu every 2 weeks x 12 months
16137526|NCT01877668|Drug|Tofacitinib 10 mg BID|Tofacitinib po 2 tablets of 5 mg BID x 12 months Placebo injections subcu every 2 weeks x 12 months
16137527|NCT01877668|Drug|Adalimumab|Placebo po 2 tablets BIDx 12 months Adalimumab 40 mg subcu injections every 2 weeks x 12 months
16137528|NCT01877668|Drug|Placebo|Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 1 tablet of 5 mg and placebo po 1 tablet BID x 9 months Placebo injections every 2 weeks x 12 months
16140066|NCT01858272|Drug|H5.020CMV.PDGF-b and limb compression bandage|
16137536|NCT01877629|Drug|ACT-129968 500 mg tablet|ACT-129968, a tetrahydropyridoindole derivative, is a chemoattractant receptor homologous molecule expressed on T helper 2 cells (CRTH2) antagonist
16137537|NCT01877629|Drug|ACT-129968 250 mg capsule|ACT-129968, a tetrahydropyridoindole derivative, is a chemoattractant receptor homologous molecule expressed on T helper 2 cells (CRTH2) antagonist
16137538|NCT01877616|Other|diagnostic test|Polysomnography
16137539|NCT01877616|Other|Diagnostic test|overnight polysomnography
16137540|NCT01877590|Drug|alpha-lipoic acid|
16137541|NCT01877577|Dietary Supplement|Vitamin D3|Study patients who took 2,000 IU daily of vitamin D3 will be compared to those who took 4,000 IU daily to determine the different effects of vitamin D3 dose on quality of life, disease activity, and the laboratory tests in this study.
16137542|NCT01877564|Drug|Metformin|
16137543|NCT01877551|Drug|Tauroursodeoxycholic acid|The intervention group will receive 1.75 grams of tauroursodeoxycholic acid daily for 30 days.
16137544|NCT01877551|Other|Placebo tablet|The placebo group will receive a placebo tablet that is identical to the treatment group except that it does not contain tauroursodeoxycholic acid. The pills will be taken once daily for 30 days.
16137545|NCT01877538|Other|[11C]donepezil PET|Positron Emission Tomography (PET) imaging of acetylcholinesterase with the ligand [11C]donepezil
16137546|NCT01877525|Procedure|Colonoscopy|The location, size, and morphology of all lesions detected during colonoscopy were recorded. The size of each identified polyp was visually estimated . All diminutive polyps (defined as ≤5 mm) were endoscopically imaged and histology predictions (adenoma vs. non-adenomatous polyp) were made using HDWL with/without NBI at the discretion of the endoscopist.
16137547|NCT01877512|Drug|Change in daily dosage of Growth Hormone|
16137548|NCT01877499|Other|Optimization of HDF key parameters|"First, patients actually receiving standard dialysis will be switched to post-dilution HDF.
~Then, a stepwise increase in 3 key parameters of the HDF prescription will be applied in a standardized way, in order to obtain the highest achievable convection volume.
~Precisely, the following 3 parameters will successively be increased towards a maximal target:
~Treatment time (up to 4 hours per session);
~Blood flow rate (up to 400 mL/min;
~Filtration fraction, defined as the ratio between extracted plasma water flow rate and blood flow rate (up to 33%).
~Maximal values for these parameters will be those achieved within pre-specified safety limits."
16137549|NCT01877486|Procedure|Ablation|Pulmonary vein isolation following dofetilide
16137550|NCT01877473|Procedure|Ablation|
16137551|NCT01877460|Other|Dietary intervention|All arms were given to all participants, in a randomized order, to be consumed within 10 min after 12-h overnight fasting.
16137552|NCT01877447|Device|Transcranial Direct Current Stimulation|Current Stimulation with cathodal stimulation over right dorsolateral prefrontal cortex. Anodal stimulation over left deltoid region
16137553|NCT01877434|Procedure|Reversed shoulder arthroplasty|
16137554|NCT01877421|Drug|2 mg KSL-W|
16137555|NCT01877421|Drug|4 mg KSL-W|
16137556|NCT01877421|Drug|6 mg KSL-W|
16137557|NCT01877421|Drug|10 mg KSL-W|
16137558|NCT01877421|Drug|20 mg KSL-W|
16137559|NCT01877421|Drug|30 mg KSL-W|
16137560|NCT01877421|Drug|50 mg KSL-W|
16137561|NCT01877421|Drug|75 mg KSL-W|
16137562|NCT01877421|Drug|100 mg KSL-W|
16137563|NCT01877421|Other|Placebo|Cetylpyridinium chloride (CPC) as an additive, isomalt as a bulk sweetener, peppermint powder for flavoring, sucralose as an intense sweetener, colloidal silicon dioxide is a flow enhancer, magnesium stearate as a process aid, and the proprietary gum base formulation.
16137564|NCT01877408|Procedure|Open surgical circumcision|Open surgical circumcision using a technique approved by the WHO (dorsal slit)
16137565|NCT01877408|Device|Unicirc device with tissue adhesive|Removal of foreskin with Unicirc disposal device and wound sealing with tissue adhesive.
16137566|NCT01877395|Biological|Purified Vero Rabies Vaccine (VRVg)|0.5 mL, Intramuscular
16137567|NCT01877395|Biological|Imovax® Rabies: inactivated rabies vaccine|1.0 mL, Intramuscular
16137568|NCT01877382|Drug|Milademetan|DS-3032b will be administered as an oral capsule. It will be supplied in 5, 20, 80, and/or 200 mg capsules individually packaged in desiccant-embedded aluminum blisters.
16137569|NCT01877382|Drug|Milademetan|Milademetan will be administered as a single oral capsule or as a combination of multiple oral capsules containing 5, 20, 80, and/or 200 mg. An alternate combination of 30 and/or 100 mg capsules of milademetan may be utilized.
16137570|NCT01877356|Procedure|bilateral spinal anesthesia|prilocaine plain 2% 50 mg
16137571|NCT01877356|Procedure|unilateral spinal anesthesia|prilocaine 2% hyperbaric 30 mg
16137572|NCT01877343|Device|CVInsight(TM)|Patient will be placed on a tilt table and pulse oximetry (Nonin Medical) and blood pressure will be measured at different table positions (different angles). Four positions will be explored. A hemodynamic monitor called CVInsight(TM) will be used to monitor the pulse oximeter readings.
16137573|NCT01877330|Procedure|Interscalene block for shoulder arthroscopy|
16137574|NCT01877317|Device|SelfFit adjusted hearing device|Comparison of threshold measurements through in-situ audiometry with full diagnostic audiometry; Comparison of First-Fit based on SelfFit-formula with conventional fitting formula NAL-NL1 (IG-measurements; Speech intelligibility with First fit of SelfFit; Speech intelligibility with Final fit of SelfFit; Comparison of fine tuning through SelfFit (Final fit) with First fit; Comparison of Final fit with Traditional fit (conventional fitted hearing aid of the test person)
16137575|NCT01877304|Device|AKITA|
16137576|NCT01877278|Device|Wearable pulsed electromagnetic fields|
16137577|NCT01877265|Drug|LY2605541|
16137578|NCT01877252|Procedure|Surgical revascularization|
16137579|NCT01877252|Procedure|Endovascular revascularization|
16137580|NCT01877252|Other|No vascular intervention|
16137581|NCT01877239|Other|non-intervention|observation of Etanercept treatment in moderately active RA patients in Austria. Etanercept treatment according to Austrian SmPC
16137582|NCT01877226|Drug|Tapentadol|Tapentadol tamper resistant prolonged-release formulation (TRF) will be administered as 250 milligram oral tablet once (in the morning, 30 minutes after breakfast) on Day 1 and 6, and twice daily (in the morning, 30 minutes after breakfast and in the evening) on Day 4 and 5.
16137628|NCT01876823|Drug|es-citalopram|es-citalopram 10mg/day will be given for the first week, and 20mg/day starting at week 2.
16137583|NCT01877213|Behavioral|Coaching with coordinate care|The coordinator nurse will manage ambulatory care with the patient's GP and participate to patient's education.
16137584|NCT01877200|Other|No treatment given|Patients will fill out a questionnaire by interview.
16137585|NCT01877187|Drug|Lipiodol|Lipiodol is used as a carrier for chemotherapy agents and also as an occlusion agent. In TACE procedures, Lipiodol is mixed with the chemotherapy agent(s) and delivered to the tumor via the hepatic artery, causing necrosis of the targeted tumor(s).
16137586|NCT01877174|Device|MICHI(TM) NPS+f|Transcarotid delivery system for carotid stents with flow reversal
16137587|NCT01877174|Procedure|transcarotid stenting|
16137588|NCT01877161|Device|Repetitive magnetic stimulation to superior temporal gyrus|Repetitive magnetic stimulation to superior temporal gyrus
16137589|NCT01877161|Device|Repetitive magnetic stimulation to middle temporal gyrus|Repetitive magnetic stimulation to middle temporal gyrus
16137590|NCT01877161|Device|Repetitive magnetic stimulation (Sham)|Repetitive magnetic stimulation (Sham)
16137591|NCT01877148|Device|tDCS|tDCS involves application of very low amplitude direct current via surface scalp electrodes. The applied current modifies the transmembrane neuronal potential and thus influences the level of excitability. Depending on the polarity of active electrodes tDCS can increase or decrease the cortical excitability. The anodal tDCS increase the excitability.
16137592|NCT01877148|Behavioral|Physiotherapy|Physiotherapy protocol followed the guidelines outlined in clinical practice guideline for physical therapy in Parkinson disease of the Royal Dutch society for physical therapy (Keus, 2007). This guideline proposes some objectives for motor rehabilitation in patients with PD, such as: flexibility, strength, coordination, balance, posture and gait. The difficulty of exercises ranged according with Hoehn and Yahr (HY) staging scale. In this way, each stage of HY had a specific physical therapy protocol following the guideline.
16137593|NCT01877122|Device|Proflex® Mesh Mesh implantation|Implantation of mesh in the incision of inguinal area
16137594|NCT01877122|Device|Marlex® Mesh Implant|
16137595|NCT01877096|Behavioral|Motivational Interviewing|A brief motivational interviewing session
16137596|NCT01877096|Behavioral|Attention Control|Participants will be asked to discuss the sources (e.g., the Internet) in which they receive information about their health. This group is designed to control for potential beneficial effects of meeting with an interventionist.
16137597|NCT01877083|Drug|Lenvatinib|Starting dose of 24 mg orally, once per day
16137598|NCT01877070|Behavioral|assessments|
16137599|NCT01877057|Dietary Supplement|Saturn|
16137600|NCT01877044|Dietary Supplement|NAXUS|
16137601|NCT01877044|Dietary Supplement|Placebo|
16137602|NCT01877031|Device|Virtual Reality|A magnetically tracked needle with an associated virtual image will be superimposed on the ultrasound image to give the user a better idea of the position of the needle.
16137603|NCT01877031|Device|Ultrasound|Standard of Care - Ultrasound guided intervention
16137604|NCT01877018|Behavioral|electronic reminder|Electronic reminder introduced into primary care medical health record, identifying invited people to the population-based colorectal cancer screening program, to promote their participation.
16137605|NCT01877005|Drug|Ruxolitinib|
16137606|NCT01876992|Drug|Metformin|
16137607|NCT01876979|Device|IMF Screws|stainless steel screws placed in bone
16137608|NCT01876979|Device|Erich Arch Bars|Surgical braces wired around teeth
16137609|NCT01876966|Drug|Etravirine|200 mg ETR b.i.d. from Day 1 to Day 21 with a single 200 mg dose of ETR in the morning on Day 22
16137610|NCT01876966|Drug|Darunavir/ritonavir|DRV/rtv 600/100 mg b.i.d. from Day 1 to Day 21 with a single dose of DRV/rtv in the morning on Day 22
16137611|NCT01876966|Drug|artemether/lumefantrine|3 days of treatment with artemether/lumefantrine 80/480 mg (6 doses of 4 tablets [20/120 mg] at 0, 8, 24, 36, 48, and 60 hours)
16137612|NCT01876953|Drug|cytarabine|Given IV
16137613|NCT01876953|Drug|idarubicin|Given IV
16137614|NCT01876953|Drug|dasatinib|Given PO
16137615|NCT01876953|Other|laboratory biomarker analysis|Correlative studies
16137616|NCT01876940|Device|air-Q, followed by fiberoptic intubation|
16137617|NCT01876940|Device|Free-hand Fiberoptic Intubation|Fiberoptic tracheal intubation will be performed without use of the air-Q and timed. Laryngeal grade of view will also be assessed
16137618|NCT01876927|Other|DOX 4 cycles - Surgery|DOX 4 cycles - Surgery
16137619|NCT01876927|Other|DOX 2 cycles - Surgery - DOX 2 cycles|DOX 2 cycles - Surgery - DOX 2 cycles
16137620|NCT01876901|Procedure|2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA)|"2-stage pull-through colo-anal anastomosis without prophylactic derivation (2SCA) Whatever the mode of continuity restoration used, resection is the same in the two groups. It consists of total excision of the rectum and its mesorectum, that intervention should be performed by laparotomy or laparoscopy.
~After surgical resection, the colon is exteriorized through the anus and attached to the buttock.
~By day 6, exteriorized colon is resected and coloanal anastomosis is performed without preventive stoma derivation"
16137621|NCT01876901|Procedure|Colo-anal anastomosis (CAA)|"After the surgical resection, coloanal anastomosis is performed usually after completion of a reservoir J when it is possible. Preventive ostomy is performed most often.
~In the absence of fistula, the patient will reoperation for stoma closure of its branch"
16137622|NCT01876875|Dietary Supplement|Energy-restricted, n-3 polysaturated fatty acids-rich diet|The active diet aimed to reduce body weight, to enhance the total intake of n-3 PUFA and to decrease the total intake of n-6 PUFAs. The diet plan was designed to supply an energy intake of 20 kcal/kg/day to maintain an ideal body weight, and followed the guidelines of the American Heart Association (AHA) 'Step-One' Diet: Carbohydrates (mainly complex carbohydrates) and protein constituted of 50-60% and 10-20% of total calories, respectively, and total fat did not exceed 30% of calories. Food values for energy and nutrients were taken from the tables of the Italian National Institute of Nutrition, Souci's Food Composition and Nutrition Tables and the European Institute of Oncology. For long-term and practical daily eating habits, it was important to easily incorporate and consume a variety of selected foods.
16137623|NCT01876875|Dietary Supplement|Usual diet|The patients of this group were randomized to continue their usual diet
16137624|NCT01876862|Other|Antiretroviral treatment interruption|pilot study in chronically HIV-infected patients with an ultralow HIV reservoir undergoing treatment-interruption.
16137629|NCT01876823|Drug|Memantine|After two weeks on Lexapro, Memantine 5mg will be added. The dose will increase to 10mg for the second week and will be increased at a rate of 5mg per week. Memantine dosage will not exceed 20mg.
16137630|NCT01876810|Drug|Gemfibrozil|600 mg of gemfibrozil (one capsule) twice daily for two weeks.
16137631|NCT01876810|Drug|Placebo|One lactose pill twice a day for two weeks.
16137632|NCT01876797|Drug|ticagrelor/prasugrel|
16137633|NCT01876784|Drug|Vandetanib (SAR390530)|"Pharmaceutical form: tablet
~Route of administration: oral"
16137634|NCT01876784|Drug|Placebo|"Pharmaceutical form: tablet
~Route of administration: oral"
16137635|NCT01876771|Drug|[177]Lu-DOTA-TATE|Peptide receptor radionuclide therapy (PPRT)
16137636|NCT01876758|Behavioral|Cognitive Intervention: Memory Training|Paper-and-pencil and computerized exercises pre- and post-ECT which may be helpful in recovering episodic memories and allow for the retention of learned strategies
16137637|NCT01876758|Behavioral|Comparable general mental stimulation|Active control will work on commercially available puzzle games at the same time prior and after ECT to determine if the developed memory training program is more effective than mere mental stimulation.
16137638|NCT01876745|Drug|eptacog alfa (activated)|Patients will be treated according to routine clinical practice at the direction of the treating physician. Data will be collected once a year after patient is registered with baseline visit until end of the study.
16137639|NCT01876732|Drug|Vitamin B12|Consented subjects are screened for Vitamin B12 deficiency with measurements of serum vitamin B12 concentrations and plasma levels of MMA, drawn prior to the first hemodialysis (HD) session of the week. Those with an MMA over 800nmol/L are given 1000mcg of IM vitamin B12 weekly for the first month and then monthly for 3 consecutive months. Following therapy, serum B12, MMA levels, percent iron saturation, parathyroid levels and peripheral blood smear are to be repeated and compared to previous levels. Subjects also complete a Kidney Disease Quality of Life- 36 (KDQOL-36) prior to therapy and again post treatment.
16137640|NCT01876719|Drug|AR08|
16137641|NCT01876719|Drug|Placebo|
16137642|NCT01876706|Device|UroLift® System|The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, and Canada. The UroLift® System is indicated for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men 50 years of age or older. During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra.
16137643|NCT01876693|Procedure|prophylactic percutaneous gastrostomy|prophylactic percutaneous gastrostomy with nutrition counselling
16137644|NCT01876680|Other|Stretching and aerobic exercise|"Stretching programme for neck/shoulder muscles three times weekly and aerobic exercise för 30 minutes three times weekly.
~Participants kept exercise diaries and physiotherapist provided support over the phone or through e-mail. The intervention lasted one year."
16137645|NCT01876680|Other|Strength training|"Stretching programme for neck/shoulder muscles three times weekly, aerobic exercise för 30 minutes three times weekly and weight training using dumbbells for the neck/shoulder area and exercises to strengthen core and leg muscles for 45 minutes three times weekly.
~Participants kept exercise diaries and physiotherapist provided support over the phone or through e-mail. The intervention lasted one year."
16137646|NCT01876667|Other|Intervention (CPCRS) Group|CPCRS staff will order evidence-based lipid-lowering and/or antihypertensive medications, adjust doses, and order follow-up laboratory parameters, as necessary under pre-approved regional treatment protocols. Patients will be monitored for medication adherence and adverse effects. Patients receive dietary, exercise, and smoking cessation counseling verbally and through mailing of pre-printed Kaiser Permanente approved, patient education pamphlets, as necessary per the discretion of the clinical pharmacy specialist. Patients requiring more dietary counseling will be referred to dieticians, education classes, or other appropriate resources offered at KPCO. Primary care providers will be informed of all medication initiations or dosage adjustments.
16137647|NCT01876667|Other|Placebo|Usual Care
16137648|NCT01876654|Device|TruMatch® patient specific cutting guide|
16137649|NCT01876641|Drug|Vemurafenib + Cobimetinib, Decitabine|
16137650|NCT01876628|Drug|Flucloxacillin and Clindamycin|Clindamycin dose 300mg four times each day for 2 days, within 48 hours of commencing flucloxacillin. Clindamycin is over-encapsulated and externally identical to placebo.
16137651|NCT01876628|Drug|Flucloxacillin and placebo|Placebo is externally identical to the over-encapsulated clindamycin and is taken four times each day for 2 days
16137652|NCT01876615|Drug|YH4808|experimental drug
16137653|NCT01876615|Drug|Diclofenac|Depain tablet 25mg
16137654|NCT01876615|Drug|YH4808+Diclofenac|
16137655|NCT01876602|Behavioral|feeling states exercise intervention|exercise prescription based on intensity of exercise that feels good.
16137656|NCT01876589|Device|Bioresorbable vascular scaffold|Drug eluting coronary stent, resorbable in 2-3 years
16137657|NCT01876589|Device|Xience Prime|Drug eluting metallic stent
16137658|NCT01876576|Other|Clear liquids|Clear liquids
16137659|NCT01876576|Other|Low residue breakfast and lunch|Low residue
16137660|NCT01876563|Dietary Supplement|vitamin D|one tab 4000 IU/day vitamin D
16137661|NCT01876563|Dietary Supplement|placebo|one tab per day placebo
16137662|NCT01876550|Drug|Mupirocin Calcium Cream, 2%|Mupirocin Calcium Cream, 2% (Taro Pharmaceuticals Inc.) applied topically 3 times per day for 10 consecutive days.
16137663|NCT01876550|Drug|Bactroban® Cream|Bactroban® Cream (mupirocin calcium cream, 2%) (GlaxoSmithKline) applied topically 3 times per day for 10 consecutive days.
16137664|NCT01876550|Drug|Cream vehicle of test product|Cream vehicle of test product (Taro Pharmaceuticals Inc.) applied topically 3 times per day for 10 consecutive days.
16137665|NCT01876537|Device|Hardware wound healing|
16137666|NCT01876537|Device|Usual Surgery|
16137667|NCT01876524|Device|Transcranial Random Noise Stimulation|Random Noise Stimulation between 100 and 500 Hz and 400-500 microAmperes are applied over head in particular areas
16137668|NCT01876511|Drug|MK-3475|MK-3475 10 mg/kg every 14 days
16137669|NCT01876498|Procedure|Xiaflex surgery|Xiaflex surgery
16137762|NCT01875744|Drug|Polyethylene glycol 4000|
16137670|NCT01876485|Behavioral|Empowering Patients in Chronic Care (EPIC)|EPIC group training sessions consisting of 6 one-hour group sessions occurring over a 6-month period. Group sessions will consist of behavioral coaching focused on diabetes management. Following each group-session, patients enrolled in the intervention arm will meet with a designated member of their primary care team to personalize diabetes goals and action plans.
16137671|NCT01876485|Behavioral|Enhanced Usual Care (EUC)|Patients randomized to EUC will be referred to the PACT RN Care Manager for diabetes management, and will also receive a packet of educational materials regarding diabetes management, including a letter delineating the diabetes management resources available at their facility.
16137672|NCT01876472|Behavioral|Assessment of music perception skills|A sequence of tones is presented to participants. Then the same sequence is presented again, with the 4th tone being one to six half tones different from the first sequence. Participants are asked to indicate when they hear a difference betweent the first and the second sequence.
16137673|NCT01876459|Other|MRI|
16137674|NCT01876459|Procedure|lumbar puncture|
16137675|NCT01876459|Behavioral|neuropsychological tests|
16137676|NCT01876446|Other|Laboratory Biomarker Analysis|Correlative studies
16137677|NCT01876446|Drug|Pegylated Irinotecan|Given IV
16137678|NCT01876446|Other|Pharmacological Study|Correlative studies
16137679|NCT01876433|Drug|Mirabegron|
16137680|NCT01876433|Drug|Placebo|
16137681|NCT01876420|Device|The CoreValve™ Evolut R TAV™ system|CoreValve™ Evolut R™ System which consists of the Evolut R™ Transcatheter Aortic Valve (26 & 29 mm sizes), EnVeo R™ Delivery Catheter System with Enveo InLine™ Sheath, and EnVeo R™ Loading System
16137682|NCT01876407|Device|Low intensity laser for oral mucositis|
16137683|NCT01876407|Device|Low intensity laser for oral mucositis switch off|Low intensity laser for oral mucositis switch off
16137684|NCT01876394|Other|Coconut Oil|Shake with 50 g Coconut oil
16137685|NCT01876394|Other|Canola Oil|Shake with 50 g Canola oil
16137686|NCT01876394|Other|Grapeseed Oil|Shake with 50 g Grapeseed oil
16137687|NCT01876394|Other|Chia Oil|Shake with 50 g Chia oil
16137688|NCT01876394|Other|Butter|Shake with 50 g Butter
16137689|NCT01876381|Drug|OPC-41061|The maximum number of days of administration will be 8 days (8 doses) in total 4 days each in the dose-escalation period and intermittant administration period. The investigational medicinal product (IMP) will be administered once daily after breakfast
16137690|NCT01876368|Drug|LCZ696|
16137691|NCT01876368|Drug|Olmesartan|
16137692|NCT01876368|Drug|Placebo of LCZ696|
16137693|NCT01876368|Drug|Placebo of Olmesartan|
16137694|NCT01876355|Drug|Clonidine|o The concentration of clonidine in the solution is 12.5 µg/ml. Continuous iv infusion of 0.02 ml/kg/h results in a dosage of 0.25 µg/kg/h. The maximum dosage achieved is 25 µg/h. The total amount of clonidine given to a person with a body weight 100 kg or more will be 600 µg a day. Since the doses chosen are in the low range, there will be no dosage adjustment for renal- or liver failure.
16137695|NCT01876355|Drug|SodiumChloride|Placebo. Pharmaceutical form: Injection. Route of administration: Intravenous use.
16137696|NCT01876342|Procedure|open repair|2-0 sutures
16137697|NCT01876342|Procedure|endoscopic TEP repair|mesh
16137698|NCT01876316|Drug|Moxifloxacin|single oral administration of 400mg of moxifloxacin
16137699|NCT01876316|Drug|Placebo|single oral administration of 400mg of placebo
16137700|NCT01876303|Other|laboratory biomarker analysis|Correlative studies
16137701|NCT01876303|Other|questionnaire administration|Ancillary studies
16137702|NCT01876290|Drug|Dexamethasone and Ondansetron|Comparison between Dexamethasone and Ondansetron and placebo in the prevention of postoperative Nausea and Vomiting
16137703|NCT01876290|Drug|Placebo|Placebo
16137704|NCT01876264|Procedure|Extended resection|
16137705|NCT01876264|Procedure|Conventional resection|
16137706|NCT01876251|Drug|PF-03084014|Tablet, 10 mg, twice a day
16137707|NCT01876251|Drug|PF-03084014|Tablet, 50 mg, twice a day
16137708|NCT01876251|Drug|PF-03084014|Tablet, 100 mg, twice a day
16137709|NCT01876251|Drug|Docetaxel|Solution for IV infusion 75 mg/m^2, every 3 weeks
16137710|NCT01876251|Drug|Docetaxel|Solution for IV infusion 100 mg/m^2, every 3 weeks
16137711|NCT01876238|Other|T-PAT|
16137712|NCT01876238|Other|Surveys|Pre-test and posttest surveys and questionnaires
16137713|NCT01876225|Behavioral|Forced coughing during cervical punch biopsy|
16137714|NCT01876212|Biological|DC vaccine|
16137715|NCT01876212|Drug|Dasatinib|
16137716|NCT01876199|Behavioral|intense follow up|
16137717|NCT01876186|Drug|Solifenacin for 12 weeks|Solifenacin 5 mg one a day for 12 weeks
16137718|NCT01876186|Drug|Solifenacin for 24 weeks|Solifenacin 5 mg once a day for 24 weeks
16137719|NCT01876173|Behavioral|Patient Decision Aid for an ICD (primary prevention, non-CRT)|The intervention group will receive the PtDA, which provides a lay summary that outlines the facts, risks, benefits (including probabilities), specific to the option of an implantable defibrillator or the option of medical management to prepare them for consultation with the physician. Values are assessed to reveal which features of each option are important to patients.
16137720|NCT01876160|Other|Transcutaneous electrical nerve stimulation|
16137721|NCT01876121|Drug|Celecoxib|oral
16137722|NCT01876108|Drug|H.pylori eradication (Omeprazole, Amoxicillin, Bismuth subcitrate, Azithromycin)|The regimen consists of Omeprazole (20 mg/BD)+ Amoxicillin (1 g/day)+ Bismuth subcitrate (240 mg/BD)+ Azithromycin (500 mg/BD)for two weeks.
16137723|NCT01876095|Procedure|Multidisciplinary medication review|"Consists of the following steps:
~1. Elderly care physician and nursing staff evaluate with the patient the experience of taking medicines, adverse drug reactions and patient's preferences.
~2. Pharmacist reviews medication to identify drug related problems using START/STOPP en Beers criteria.
~3/4. Meeting of elderly care physician, pharmacist. Possibilities to discontinue prescribed medication will be examined resulting in pharmaceutical care plan that optimizes the patient's medication i.e. which inappropriate medication should be discontinued following a prioritization and time schedule.
~5. Execution of pharmaceutical care plan according to agreed schedule."
16137891|NCT01874743|Drug|Rosuvastatin 20 mg/day|All patients must take 20mg/day of rosavastatin during 3 months
16137724|NCT01876082|Drug|PAZOPANIB treatment|"Pazopanib
~800 mg per day
~oral administration
~at least 1 hour before or 2 hours after a meal,
~until disease progression or for 12 months maximum"
16137725|NCT01876082|Drug|Active Comparator: Vinblastine and Methotrexate|Active Comparator: Vinblastine and Methotrexate vinblastine 5 mg / m², methotrexate 30 mg / m (J1, J8, J15, J21, 6 months and then J1, J15) 28 days per cycle until disease progression or for 12 months.
16137726|NCT01876069|Device|22 gauge ProCore needle aspiration|Pancreatic mass evaluation through the 22 gauge ProCore needle aspiration
16137727|NCT01876069|Device|22 gauge Fine needle aspiration|Pancreatic mass evaluation through the 22 gauge Fine needle aspiration
16137728|NCT01876056|Behavioral|Brief CaCBTp|Brief CBT for psychosis is comonly used in the West and had an established evidence base. Recently this therapy has been culturally adapted for use with clients from Pakistan.
16137729|NCT01876043|Drug|plitidepsin|"Patients received plitidepsin as an i.v. 3-h infusion of 5 mg/m2/day on days 1 and 15 every 4 weeks. Patients discontinued plitidepsin if one of the following occurred: consent withdrawal, unacceptable toxicity, disease progression (RECIST v1.1), intercurrent illness or investigator's decision.
~Single-arm phase II clinical trial based on a two-stage optimal Simon's design with 37 evaluable patients (first stage: 17 patients) used to distinguish a favorable true non-progression rate of 40% from a null rate of 20% (90% power and 10% type I error).
~Stage 1(17 participants): if <=3 non-progressions at 3 months, the study was stopped early. Otherwise, the second group of 20 participants was recruited.
~Stage 2 (37 participants): if >= 11 non-progressions, Aplidin was considered promising."
16137730|NCT01876030|Device|FES|
16137731|NCT01876017|Biological|Intravenous transfer of Autologous (BMMNCs)|Intervention therapy , Total 3 doses ,in 30 days ,in 7days interval Intravenous transfer of Autologous (BMMNCs)
16137732|NCT01876004|Drug|Methotrexate|50 mg/m2, IM (intramuscularly), single dose
16137733|NCT01876004|Drug|Placebo|Prescribed Placebo IM (intramuscularly), single dose
16137734|NCT01875991|Drug|Etanercept via Autoinjector A|Autoinjector A is a hand-held, reusable, electromechanical device used with a single-use disposable cassette preassembled with an etanercept 50-mg prefilled syringe.
16137735|NCT01875991|Drug|Etanercept via Autoinjector B|Autoinjector B is a single-use, spring-loaded, self-contained autoinjector preassembled with an etanercept 50-mg prefilled syringe.
16137736|NCT01875978|Dietary Supplement|Phytosterols & placebo|Group A:Phytosterols 1.8g/day with one meal for 4 weeks first;group B:placebo first
16137737|NCT01875952|Drug|Isoniazid|Isoniazid, 10 mg/Kg/day, no more than 300 mg/day, for six months
16137738|NCT01875939|Drug|Oral WCK2349|The subjects will be randomly assigned to receive WCK 2349 1000 mg as an oral dose in fed or fasting state (1:1) in the food effect study as per the randomization schedule. The subjects completing the food effect study (i.e., Period 1 and Period 2) will be administered WCK 771 800 mg as an intravenous infusion in fasting state in Period 3 of the study.
16137739|NCT01875939|Drug|IV WCK771|The subjects will be randomly assigned to receive WCK 2349 1000 mg as an oral dose in fed or fasting state (1:1) in the food effect study as per the randomization schedule. The subjects completing the food effect study (i.e., Period 1 and Period 2) will be administered WCK 771 800 mg as an intravenous infusion in fasting state in Period 3 of the study.
16137740|NCT01875926|Biological|ALX-0171|single dose of 200 mg ALX-0171 via oral inhalation
16137741|NCT01875926|Biological|ALX-0171|repeated doses of 200 mg ALX-0171 via oral inhalation once daily for 5 consecutive days
16137742|NCT01875926|Biological|ALX-0171|Single dose of 0.3 mg/kg body weight ALX-0171 via intravenous administration
16137743|NCT01875913|Behavioral|Curiosity Message|Participants will receive email messages that contain one of 8 curiosity-inducing questions. The message will tell participants that they will receive a message with the answer after they complete their VHR (health review that can be completed online).
16137744|NCT01875913|Behavioral|Standard Message|"Participants will receive email messages that contain standard language encouraging them to complete their VHRs (health review that can be completed online)."
16137745|NCT01875900|Other|Video-assisted learning and self-directed training|The Neonatal Resuscitation Program (NRP) DVD will be provided for video study and a low-fidelity newborn manikin for self-directed resuscitation training (90 minutes training time, six students per group).
16137746|NCT01875900|Other|Simulation-based neonatal resuscitation training|Students will learn initial assessment of newborns and basic resuscitation skills and actively apply these skills during simulated clinical scenarios both with a low- and high-fidelity manikin (90 minutes training time, six students per group).
16137747|NCT01875887|Procedure|rapid prototyping technology|Rapid prototyping technology was applied in treatment of bilateral maxillofacial post-traumatic deformities
16137748|NCT01875874|Biological|ELAD|Continuous treatment with the ELAD System for a minimum of 3 days to a maximum of 10 days. The subject's ultrafiltrated blood is circulated through 4 cartridges, each containing approximately 110 grams of C3A cells (approximately 440 grams total).
16137749|NCT01875861|Other|Evidence-Based Quality Improvement Plus Facilitation|The intervention involves researchers partnering with clinical stakeholders, offering tailoring in local implementation strategies to address barriers to metabolic side-effect monitoring and management. External facilitation to support, problem-solve and refine implementation will be provided for a six-month implementation phase.
16137750|NCT01875848|Drug|buprenorphine/naloxone|partial opioid agonist
16137751|NCT01875848|Drug|opioid dose escalation|up to 25% increase in patient's current opioid dose
16137752|NCT01875835|Device|Xience™ V stent (Abbott Vascular, Santa Clara, California, USA)|
16137753|NCT01875835|Device|Multilink-Vision stent(Abbott Vascular, Santa Clara, California, USA)|
16137754|NCT01875822|Dietary Supplement|Super-Curcumin|The investigators are comparing the effects of the two dosages of Super-Curcumin@ capsules in the sample of subjects diagnosed as DSM IV-R schizophrenia
16137755|NCT01875796|Behavioral|Cognitive-Behavioral Therapy|
16137756|NCT01875796|Behavioral|Motivation Enhancement Therapy|
16137757|NCT01875796|Behavioral|Integrated Cannabis and Anxiety Reduction Treatment|
16137758|NCT01875796|Behavioral|False Safety Behavior Elimination Therapy|
16137759|NCT01875783|Device|OCT imaging|Optical coherence tomography (OCT) imaging is a noninvasive, rapid, and readily performed method for evaluating the anatomy of the central retina.
16137760|NCT01875757|Drug|Vitamin D3|
16137761|NCT01875757|Drug|Placebo|
16137763|NCT01875731|Behavioral|BPS|In this study a strategy based on BPS guided antibiotic use in children with community acquired pneumonia implementation will be compared with enforced guideline.
16137764|NCT01875731|Behavioral|Guideline|Strategy based on enforced guideline guided antibiotic use
16137765|NCT01875718|Drug|UC1010|
16137766|NCT01875718|Drug|Placebo|
16137767|NCT01875705|Drug|GDC-0994|Escalating doses of GDC-0994 until maximum tolerated dose is reached
16137768|NCT01875705|Drug|GDC-0994|Recommended dose determined in Stage I-Dose Escalation phase, until disease progression
16137769|NCT01875679|Other|Comprehensive Surgical Coaching|
16137770|NCT01875679|Other|Conventional Surgical Training|Surgical training as per participant's residency program
16137771|NCT01875666|Drug|Trastuzumab|8 mg/kg IV, single dose
16137772|NCT01875666|Drug|pertuzumab|840 mg IV single dose
16137773|NCT01875666|Drug|lapatinib|1000 mg daily for 7 days
16137774|NCT01875653|Biological|Autologous Dendritic Cell-Tumor Cell Immunotherapy (DC-TC)|Comparison of a cancer treatment containing patient specific irradiated tumor cells mixed with antigen presenting immune cells suspended in an immune system stimulant vs. a cancer treatment containing patient specific immune cells suspended in an immune system stimulant
16137775|NCT01875653|Biological|Autologous PBMCs in GM-CSF (MC)|Comparison of a cancer treatment containing patient specific irradiated tumor cells mixed with antigen presenting immune cells suspended in an immune system stimulant vs. a cancer treatment containing patient specific immune cells suspended in an immune system stimulant
16137776|NCT01875627|Dietary Supplement|Konjac noodles|Replacement of carbohydrate noodles with non-caloric Konjac noodles (viscous gel meal)
16137777|NCT01875627|Dietary Supplement|Carbohydrate and Konjac Noodles|
16137778|NCT01875627|Dietary Supplement|Carbohydrate noodles|
16137779|NCT01875601|Biological|Recombinant human interleukin-15 (rhIL-15)|Continuous infusion rhIL15 IV
16137780|NCT01875601|Biological|NK Cell Infusion|Infuse expanded NK cells at Day 0 after 2 days of Cyclophosphamide lymphodepletion
16137781|NCT01875575|Dietary Supplement|Placebo|
16137782|NCT01875575|Dietary Supplement|Glucose 25g|
16137783|NCT01875575|Dietary Supplement|Glucose 10g|
16137784|NCT01875562|Drug|Qishe Pill|Pill, 3.75 g, twice per day, four weeks
16137785|NCT01875549|Device|stent insertion|to use a LCD stent at an unilateral or bilateral stent insertion
16137786|NCT01875549|Procedure|Endoscopic retrograde cholangiopancreatoscopy(ERCP)|to use ERCP for a stent insertion in an obstructive biliary tract
16137787|NCT01875536|Device|rTMS|The subjects were seated in a comfortable chair with head and arm rests. Focal TMS of the motor cortex was performed with a 70-mm figure-8 coil attached to magnetic stimulator stimulation parameters : frequency of 1Hz on the uninjured hemisphere by stroke; 1500 pulses with an intensity of 90% of MT 10 sessions of rTMS, one per day, always before conventional physical therapy
16137788|NCT01875536|Behavioral|conventional physical therapy|The physical therapy program was composed of the activities of flexibility, transfer and posture, strength, coordination, balance, and sensory stimulation. The physical therapy was applied for about 30 minutes, three days per week.
16137789|NCT01875523|Drug|Serelaxin|
16137790|NCT01875510|Dietary Supplement|Fish-oil emulsions|"Fish -oil emulsions:
~Preterm infants will receive a fish-oil emulsion administered from the first day of life 1gr/kg, second day 2gr/kg and third day and after 3 gr/kg."
16137791|NCT01875510|Dietary Supplement|soybean-oil emulsion|soybean-oil emulsion
16137792|NCT01875497|Dietary Supplement|grape fruit (vitis vinifera) extract in capsule with 205 mg|Before the exercise the indivuduals intake only one capsule of the grape fruit extract with 205 mg. This dosage is free of contraindications according to others studies.
16137793|NCT01875471|Device|delefilcon A|Daily disposable soft contact lens to be worn at least 8 hours daily
16137794|NCT01875471|Device|narafilcon A|Daily disposable contact lens to be worn at least 8 hours daily
16137795|NCT01875445|Drug|Inositol|Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study.
16137796|NCT01875445|Drug|Placebo|Taken as 2g of powder TID for 2 weeks, then 4g of powder TID for 2 weeks and then 6g of powder TID for the remainder of the study.
16137797|NCT01875419|Device|Transcranial direct current stimulation (tDCS)|"Patients - tDCS arm: 1 mA current delivered for 20 minutes once a week for 8 weeks, immediately prior to CBT.
~Patients - Sham arm: brief current change at the beginning (0 min) and end of each stimulation session (20 min) in order to mimic the effect of an actual stimulation, but no current delivered in between."
16137798|NCT01875419|Behavioral|Cognitive Behavioural Therapy|8 sessions of one hour (once weekly) immediately after tDCS or sham stimulation
16137799|NCT01875406|Other|diagnostic exercises|
16137800|NCT01875393|Drug|TOOKAD® Soluble|The VTP procedure will consist of a single, 10 minute infusion of 4mg/kg TOOKAD® Soluble. The drug will be activated by laser light at 753nm, with a fixed energy of 200Joules/cm, and a fixed power of 150mWatts/cm, delivered through transperineal interstitial optical fibers. The needles are positioned in the prostate under ultra sound image guidance.
16137801|NCT01875380|Drug|Regorafenib|
16137802|NCT01875367|Drug|Trastuzumab Injectable Solution|Subcutaneous injection vial with a fixed dose of trastuzumab (600mg) and recombinant human hyaluronidase (10.000U) identical to that provided by the device. 3 weeks x 2 cycles.
16137803|NCT01875367|Drug|Trastuzumab Injectable Product|Single injection device is provided and loaded with the mixture of trastuzumab (600mg) and recombinant human hyaluronidase (10.000U) and is ready for use. 3 weeks x 2 cycles
16137804|NCT01875367|Drug|Trastuzumab Injection|Powder for concentrate for solution for infusion. 1 cycle
16137805|NCT01875354|Dietary Supplement|Dietary Supplements and TR90 Eating Plan|Supplements to maintain muscle, assist in utilization of body fat, curb appetite, support positive willpower along with TR90 Eating plan. TR90 Eating Plan will consist of approximately 30 g high quality protein along with fruit, vegetables and complex carbohydrates
16137806|NCT01875354|Dietary Supplement|Placebo and Low Fat Eating Plan|
16137847|NCT01875068|Behavioral|Consultations between NPs and PAs and their supervising physicians|Required discussion with physician prior to referral by a nurse practitioner or physician assistant
16137848|NCT01875068|Behavioral|versus NPs and PAs who are not required to discuss patient referrals (control group).|
16137807|NCT01875341|Device|NCPAP; Nasal continuous positive airway pressure.|Patients will be randomized to receive either therapeutic or sub-therapeutic NCPAP; Nasal continuous positive airway pressure treatment. In patients randomized to therapeutic NCPAP, treatment pressures will be increased until apneas and hypopneas are prevented during all sleep stages. In the sub-therapeutic treatment group, pressure will be left unchanged at the lowest possible value for the NCPAP device. Pressure settings for NCPAP therapy will be determined by Dr. J. Leech, collaborator and specialist in sleep disorders. Treatment will be continued for a total of 6 weeks.
16137808|NCT01875341|Device|NCPAP Nasal Continuous Positive Airway Pressure-sub-therapeutic treatment group|In the sub-therapeutic treatment group, pressure will be left unchanged at the lowest possible value for the NCPAP device. Pressure settings for NCPAP therapy will be determined by Dr. J. Leech, collaborator and specialist in sleep disorders. Treatment will be continued for a total of 6 weeks.
16137809|NCT01875328|Other|Telemedicine|Post stroke follow up in home using telemedicine.
16137810|NCT01875328|Other|Clinic|Post stroke clinic group follow up
16137811|NCT01875315|Other|Diagnostic Cardiac Imaging|
16137812|NCT01875289|Procedure|obturator nerve block|
16137813|NCT01875263|Drug|Cloxacilin|2g/4 hours i.v., 5 days
16137814|NCT01875263|Drug|Cloxacillin|2g/4h 14 days Standard therapy
16137815|NCT01875263|Drug|Levofloxacin|500 mg v.o./24h, 9 days
16137816|NCT01875250|Biological|PROSTVAC-F (Fowlpox)/TRICOM|A recombinant fowlpox virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.
16137817|NCT01875250|Biological|PROSTVAC-V (Vaccinia)/TRICOM|A recombinant vaccinia virus vector vaccine containing the genes for human prostate specific antigen (PSA) and three co-stimulatory molecules.
16137818|NCT01875250|Drug|Enzalutamide (Xtandi)|An androgen receptor inhibitor.
16137819|NCT01875237|Drug|Fludarabine|40 mg/m2 by vein on Days -6 to -3.
16137820|NCT01875237|Drug|Melphalan|140 mg/m2 by vein on Day -2.
16137821|NCT01875237|Drug|Alemtuzumab|50 mg by vein on Day -1.
16137822|NCT01875237|Procedure|Stem Cell infusion|Stem cell infusion on Day 0. Goal is to administer more than 3 x 10^6 CD34+ cells/kg of peripheral blood progenitor cells (PBPC).
16137823|NCT01875237|Drug|Tacrolimus|Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml (target is 10 ng/ml) between Day +1 and Day +45. Tacrolimus is changed to oral dosing when tolerated. Tacrolimus tapering should start on approximately Day +35 with the intention for the patient to be completely off the drug by approximately Day +45.
16137824|NCT01875237|Drug|Mini Methotrexate|5 mg/m2 by vein on Days +1, +3, +6.
16137825|NCT01875237|Drug|G-CSF|5 mcg/kg/day subcutaneously beginning on Day +7, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
16137826|NCT01875237|Procedure|Donor Lymphocyte Infusion (DLI)|iCasp9 (BPZ-1001)-Modified T-cells) of 3 X 10^6/kg in 100 ml infused over approximately a one hour period between Day + 56 to Day +64.
16137827|NCT01875237|Drug|AP1903|0.4 mg/kg as a 2 hour infusion for patients that present with a clinical diagnosis of grade I GvHD. For patients with a clinical diagnosis of grade > 2 GvHD, a single dose of AP1903 0.4 mg/kg as a 2 hour infusion will be administered. Patients who fail to achieve a complete response within 72 hours of an initial dose of AP1903, or within 48 hours of a second dose of AP1903, will be maintained on this dose for no less than 7 days. Patients who experience a partial response within 72 hours may receive a second dose of AP1903. Patients whose GvHD is progressing after 7 days, have no response by 14 days, or are not in a complete response at day 28 can receive secondary therapy.
16137828|NCT01875237|Drug|Methylprednisolone|1.6 mg/kg per day by vein divided in 2 to 3 daily doses. Patients whose GvHD resolves as defined by a complete response within 72 hours, would have steroids stopped immediately. Patients who fail to achieve a complete response within 72 hours of an initial dose of AP1903, or within 48 hours of a second dose of AP1903, will be maintained on this dose for no less than 7 days. Steroids can then be tapered as tolerated to no less than 0.6 mg/kg per day at day 28.
16137829|NCT01875237|Behavioral|Questionnaire|Completion of a quality of life questionnaire that will take 10-15 minutes between Days + 28 and + 56, about twice a week until about 2 months after the T-cell infusion, and then 6 and 12 months after the stem cell transplant.
16137830|NCT01875224|Drug|Belatacept|
16137831|NCT01875224|Drug|Tacrolimus|Standard administration of tacrolimus
16137832|NCT01875198|Procedure|Radical Antegrade Modular Pancreatectomy with Splenectomy|
16137833|NCT01875198|Procedure|Radical Antegrade Modular Pancreatectomy without splenectomy|distal pancreatectomy without pancreatectomy
16137834|NCT01875185|Drug|Aspirin 81 mg|Aspirin 81 mg orally daily for 7 days
16137835|NCT01875172|Drug|Bupropion SR|Comparison of bupropion SR or placebo + smoking cessation counseling
16137836|NCT01875172|Drug|placebo|
16137837|NCT01875172|Behavioral|smoking cessation counseling|
16137838|NCT01875159|Drug|Caffeine citrate 6 mg/kg/day|Comparison of caffeine citrate 6 mg/kg/day versus no caffeine (usual care) on extent of intermittent hypoxia at 35, 36, 37, 38, 39, and 40 weeks postmenstrual age.
16137839|NCT01875146|Other|4x4 min HIT|Conventional 4x4 min high-intensity interval training
16137840|NCT01875146|Other|4x4 min HIT + WBV (18 Hz)|4x4 min high-intensity interval training in combination with whole-body vibration at 18 Hz during the active rest
16137841|NCT01875146|Other|4x4 min HIT + (30 Hz)|4x4 min high-intensity interval training in combination with whole-body vibration at 30 Hz during the active rest
16137842|NCT01875146|Other|whole-body vibration at 30 Hz|4x3 min whole-body vibration at 30 Hz
16137843|NCT01875133|Other|altitude exposure|stay at different altitudes: 490, 1630, 2590 m
16137844|NCT01875107|Drug|insulin pre-treatment|insulin pre-treatment of pregnant diabetic patients who receive betamethasone
16137845|NCT01875094|Other|Self-Management / MTM using Health IT|
16137846|NCT01875081|Biological|Livercellgram|"Livercellgram
~Dosage form and appearance: White cell suspension is filled in a clear plastic syringe, and fixed with an occlude on the prefilled syringe tip ② Component: Autologous bone marrow-derived mesenchymal stem cell ③ Amount: 5X107 cells, 1-time or 2-time injection ④ Storage Method: Stored in airtight container at 20~25℃
~Injection Method: Directly inject into liver through hepatic artery"
16137890|NCT01874756|Drug|LY500307 25mg|LY500307 25mg daily dose (1 capsules of 25mg and 5 capsules of placebo) for 8 weeks
16137849|NCT01875055|Device|NIRS and Algorithm|NIRS cerebral oximetry will be used to guide the use of an algorithm based on the modification of previously defined important physiologic variables will be initiated to reverse the desaturation (beginning when the saturation drops at least 10% from the baseline) that occur in the ICU
16137850|NCT01875055|Device|NIRS derived cerebral oximetry|NIRS sensors will be placed the forehead of the patient but NIRS derived data will be blinded to the ICU caregivers
16137851|NCT01875042|Device|TENS|Transcutaneous electrical nerve stimulation
16137852|NCT01875042|Device|Sham TENS|Sham Transcutaneous electrical nerve stimulation
16137853|NCT01875029|Device|sham-tDCS + back school|sham tDCS + back school
16137854|NCT01875029|Device|real-tDCS + back school|real tDCS + back school
16137855|NCT01875016|Procedure|CRyo-Ablation to Treat HOCM.|CRyo-Ablation to Treat Patients With HOCM.
16137856|NCT01875003|Drug|Lebrikizumab|Lebrikizumab will be administered as SC injection at high or low dose Q4W.
16137857|NCT01875003|Drug|Placebo|Lebrikizumab matching placebo will be administered as SC injection Q4W.
16137858|NCT01875003|Drug|Standard of Care|Participants will continue to receive ICS therapy (total daily dose of 500-2000 mcg fluticasone propionate DPI or equivalent) along with at least one second controller medications (e.g. long-acting beta agonists [LABAs], leukotriene receptor antagonists (LTRAs), long-acting muscarinic antagonists (LAMAs), or theophylline) as standard of care.
16137859|NCT01874990|Dietary Supplement|high sodium diet|The high-sodium diet was obtained by adding 6g of sodium chloride to the individual's regular diet
16137860|NCT01874990|Dietary Supplement|low-salt diet|
16137861|NCT01874977|Behavioral|Pedometer|Will receive the educational booklet and discussion, plus a pedometer and a diary to record their daily step counts from the pedometer.
16137862|NCT01874977|Behavioral|Educational materials|"Will receive the educational booklet (Be Active Your Way: A guide for Adults; http://www.health.gov/paguidelines/adultguide/default.aspx).and a discussion of simple ways to increase physical activity in daily life based on the booklet, following the baseline assessment."
16137863|NCT01874977|Behavioral|Step count goals|Will receive the educational booklet and discussion, and the pedometer and step diary, plus will be given individualized daily step targets.
16137864|NCT01874964|Behavioral|Methadone Maintenance|Individuals who are enrolled in methadone maintenance treatment at the time of incarceration are maintained on pre-incarceration dosage levels of methadone during short-term (6 months or less)incarceration. They will be actively assisted to return to their home clinic upon release and receive 10 financial assistance with treatment payments.
16137865|NCT01874964|Behavioral|Linkage to methadone maintenance|Individuals in the comparison arm will undergo methadone detoxification during short term incarceration, however, they will be actively assisted to return to their home clinic upon release and receive 10 financial assistance with treatment payments.
16137866|NCT01874951|Drug|Naltrexone|1 mg of naltrexone will be given twice daily to all patients assigned to active drug.
16137867|NCT01874951|Drug|Placebo|Placebo identical in appearance to naltrexone will be given twice daily to all patients assigned to placebo.
16137868|NCT01874938|Biological|LY2875358|Administered IV
16137869|NCT01874899|Device|RestoreSensor Neurostimulation|
16137870|NCT01874873|Drug|Anlotinib|
16137871|NCT01874860|Drug|Doxycycline|Doxycycline capsule, 100 mg, taken twice daily
16137872|NCT01874860|Drug|Hydrocortisone 1% cream|Applied to the face, hands, feet, neck, back, and chest each evening (Topical cream)
16137873|NCT01874860|Other|Sunscreen|Applied to exposed skin areas at least 30 minutes before going outdoors each morning.
16137874|NCT01874860|Other|Moisturizer|Applied to the face, hands, feet, neck, back, and chest each morning after sunscreen
16137875|NCT01874860|Drug|Clindamycin|Recommended for daily use if rash returns (Topical cream)
16137876|NCT01874860|Drug|Medrol-dose pack (Steroid)|Patients will receive a Medrol dose-pack while continuing the extensive treatment regimen.
16137877|NCT01874847|Dietary Supplement|Melatonin|Melatonin 10mg or 3mg capsule, one will be given at night, for 28 days
16137878|NCT01874847|Dietary Supplement|Sugar pill|Sugar pill will be given, one capsule, once at night, for 28 days
16137879|NCT01874834|Other|ozone|Exposure to 300 ppb ozone with intermittent exercise about 20 hr after exposure to each arm (ie, either air, ozone, diesel exhaust, or ozone combined with diesel exhaust)
16137880|NCT01874821|Device|Dynasplint|"Dynamic splinting utilizes the protocols of Low-Load Prolonged Stretch (LLPS) with calibrated adjustable tension to increase Total End Range Time (TERT)to reduce contracture. The Dynasplint or Experimental group will add this therapy to their standard of care regimen"
16137881|NCT01874821|Other|Standard of Care|The current Standard of Care for treating this condition includes corticosteroid injections and physical therapy.
16137882|NCT01874795|Device|TENS|Adhesive electrodes (MultiStick®, USA) were placed on each side, about 3 cm to the right and left of midline vertebral process, at C7 (Channel 1) and T4 (Channel 2).
16137883|NCT01874795|Device|Placebo|The frequency of stimulation was 80 Hz and the pulse duration was 150 μs, equipment did not provide stimulation current.
16137884|NCT01874782|Device|transcranial electrical stimulation|TES: medical device TRANSAIR: electrodes placed on the forehead and over the mastoid processes using Velcro straps. Treatment protocol: six 30-minute sessions over a two-week period and stimulation variables (bipolar current; 1.0-3.0 milliamp (mA) amplitude, 3.5 ms duration and 77.5 Hz frequency).
16137885|NCT01874769|Other|Blood collection|"5 ml of blood on dry tube: Verification of the absence of auto-antibodies to type VII collagen.
~10 ml of blood sample on heparin: Verification of the absence of circulating reactive T-Lymphocytes clones to type VII collagen
~5 ml of Blood samples on ethylenediaminetetraacetic acid (EDTA): HLA genotyping of patient selected on the clinical and molecular criteria."
16137886|NCT01874769|Other|Skin biopsies|"A 5-mm punch skin biopsy in the groin region performed under local anaesthesic will be undertaken during visit 1.
~During the second visit, two additional 5-mm punch skin biopsies will be taken to assess stem cells proliferative capacity in 10 shortlisted patients"
16137887|NCT01874756|Drug|LY500307 150mg|LY500307 150mg daily dose (6 capsules of 25mg) for 8 weeks
16137888|NCT01874756|Drug|LY500307 75mg|LY500307 75mg daily dose (3 capsules of 25mg and 3 capsules of placebo) for 8 weeks
16137889|NCT01874756|Drug|Placebo|6 placebo capsules daily for 8 weeks
16138093|NCT01873183|Other|Goal directed fluid therapy|
16137892|NCT01874730|Other|Combined epidural-general anesthesia (CEGA)|Combined epidural-general anesthesia (CEGA) will be used intraoperatively and patient-controlled epidural analgesia (PCEA) will be used postoperatively in a multimodal analgesic regimen.
16137893|NCT01874730|Drug|Volulyte® (6% HES 130/0.4 in balanced solution)|"For the SOC Group: Intraoperative fluid management includes Volulyte® (6% HES 130/0.4 in balanced solution) as the only colloid solution to be used, the daily dosage of Volulyte® is restricted to 50 ml/kg.
~For the ERS Group:
~GDFT regimen will be utilized using Volulyte® (6% HES 130/0.4 in balanced solution) during surgery. The daily dosage of Volulyte® is restricted to 50 ml/kg."
16137894|NCT01874730|Other|Patient-Controlled Epidural Analgesia (PCEA)|For the ERS Group, patient-controlled epidural analgesia (PCEA) will be used postoperatively in a multimodal analgesic regimen.
16137895|NCT01874717|Other|Conscious sedation for dental care|
16137896|NCT01874717|Drug|midazolam|
16137897|NCT01874704|Behavioral|Comparison of biomarkers of stress|
16137898|NCT01874678|Drug|TS-1/Cisplatin|
16137899|NCT01874665|Drug|Ponatinib|Ponatinib 45 mg, tablets, orally, once-daily.
16137900|NCT01874652|Device|Light Weight Breast Implants|Light Weight Breast Implants
16137901|NCT01874639|Device|standard bipolar coagulation|
16137902|NCT01874639|Device|Aquamantys® probe for liver hemostasis|
16137903|NCT01874626|Drug|Placebo|Placebo cream
16137904|NCT01874626|Drug|SST-0225 Topical Ibuprofen Cream|SST-0225 Topical Ibuprofen Cream
16137905|NCT01874613|Device|FRC implant reconstruction|A cranioplasty with the FRC implant is performed.
16137906|NCT01874613|Device|FRC implant reconstruction|The orbital floor fracture is reconstructed with the FRC implant.
16137907|NCT01874600|Device|Brain Sentinel Seizure Detection Device and Warning System|The Brain Sentinel Seizure Detection Device and Warning System is designed to monitor Epilepsy patients and alerts caregivers that a GTC seizure is occurring
16137908|NCT01874587|Radiation|adaptative radiotherapy|weekly replanning
16137909|NCT01874574|Drug|Hylan G-F 20|After full aseptic preparation, Single shot intra-articular injection either 6 mL of Hylan G-F 20 or 1 mL of 40 mg triamcinolone acetonide plus 5 mL of 1% xylocaine with adrenaline were injected into the joint cavity using the infero-lateral approach via a 21-gauge needle.
16137910|NCT01874574|Drug|Corticosteroid|After full aseptic preparation, Single shot intra-articular injection either 6 mL of Hylan G-F 20 or 1 mL of 40 mg triamcinolone acetonide plus 5 mL of 1% xylocaine with adrenaline were injected into the joint cavity using the infero-lateral approach via a 21-gauge needle.
16137911|NCT01874561|Drug|Custirsen|Custirsen will be administered iv using an infusion pump over a 2-hour period.
16137912|NCT01874561|Drug|Placebo|Placebo (commercially available normal saline) will be administered iv using an infusion pump over a 2-hour period.
16137913|NCT01874561|Drug|Moxifloxacin|Moxifloxacin (400 mg) will be administered orally with 240 mL of room temperature still water.
16137914|NCT01874535|Drug|Esomeprazole 40 mg|Comparison of 4-weeks and 8-weeks initial treatment duration of esomeprazole 40 mg per day on the rate of symptom relapse and sustained healing of esophagitis in patients with symptomatic erosive esophagitis
16137915|NCT01874522|Drug|TAS-102 tablets|"Crossover bioavailability part: 60 mg/dose, orally, up to 2 single doses separated by 1-week washout.
~Extension part: 35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met."
16137916|NCT01874522|Drug|TAS-102 oral solution|60 mg/dose, orally, up to 2 single doses separated by 1-week washout
16137917|NCT01874509|Behavioral|Check Your Drinking|
16137918|NCT01874509|Behavioral|Alcohol Help Centre|
16137919|NCT01874496|Dietary Supplement|GDS, no meal|GDS, no meal
16137920|NCT01874496|Dietary Supplement|GDS, meal|GDS, meal
16137921|NCT01874496|Dietary Supplement|control, no meal|control, no meal
16137922|NCT01874496|Dietary Supplement|control, meal|control, meal
16137923|NCT01874483|Drug|Placebo|placebo
16137924|NCT01874483|Drug|BI 187004|BI 187004, dose 2
16137925|NCT01874483|Drug|BI 187004|BI 187004, dose 4
16137926|NCT01874483|Drug|BI 187004|BI 187004, dose 5
16137927|NCT01874483|Drug|BI 187004|BI 187004, dose 6
16137928|NCT01874483|Drug|BI 187004|BI 187004, dose 7
16137929|NCT01874483|Drug|BI 187004|BI 187004, dose 1
16137930|NCT01874483|Drug|BI 187004|BI 187004, dose 3
16137931|NCT01874470|Device|renal denervation|
16137932|NCT01874470|Other|standard medication|
16137933|NCT01874457|Biological|MMR (Mumps, Measles and Rubella)|MMR (Mumps, Measles and Rubella)
16137934|NCT01874444|Device|1|repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 1000 stimuli of 1Hz rTMS over the left DLPFC (110% motor threshold) followed by 2000 stimuli of 1 Hz rTMS over the left temporal cortex (110% motor threshold), each consisting of 4 days of rTMS treatment. Participants will have an MRI scan and MEG recoding at the performed a week before rTMS. And MEG recording after 7day the application of rTMS
16137935|NCT01874444|Device|2|"repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 3000 stimuli of 1 Hz rTMS over the left temporal cortex (110% motor threshold), each consisting of 4 days of rTMS treatment.
~Participants will have an MRI scan and MEG recoding at the performed a week before rTMS. And MEG recording after 7day the application of rTMS."
16137936|NCT01874444|Device|3|"repetitive transcranial magnetic stimulation (Figured 8-Coil MCF-B65): 3000 stimuli of 1 Hz rTMS over the left frontal cortex (110% motor threshold) each consisting of 4 days of rTMS treatment.
~Participants will have an MRI scan and MEG recoding at the performed a week before rTMS. And MEG recording after 7day the application of rTMS."
16137937|NCT01874444|Device|4|"Sham rTMS, applied with the same combination of parameters as active rTMS, except for the number of stimulations per session.
~Participants will have an MRI scan and MEG recoding at the performed a week before rTMS. And MEG recording after 7day the application of rTMS."
16137938|NCT01874431|Drug|Finerenone (BAY94-8862)|
16137939|NCT01874431|Drug|Placebo|
16137940|NCT01874418|Other|Biomarker|Oligomeric beta-amyloid 42 in serum, as well as, monomeric beta-amyloid 42, total tau and phosphorylated tau in CSF
16137941|NCT01874392|Drug|Investigational inhaled insulin (Technosphere)|by MannKind Corp. IND 61,729
16138094|NCT01873170|Drug|levonorgestrel exposure|
16137942|NCT01874392|Device|Artificial Pancreas (AP) device (APS©)|"Device includes:
~OneTouch® Ping® Glucose Management System with modified Meter-Remote from Animas® Corp or the OmniPod® Insulin Management System from Insulet Corp.
~Dexcom® G4® CGM System (CGM) from Dexcom® Corp
~Control algorithm: zone-Model Predictive Control (zone-MPC) with safety Health Monitoring System (HMS)"
16137943|NCT01874379|Other|'M'-Technique®|'M'-Technique is a series of gentle stroking movements performed in a set sequence, with a set pressure of 3 on a scale of 0-10.
16137944|NCT01874379|Other|Guided Imagery|Diane L. Tusek's Guided Imagery for Pre-Procedure/Surgery™ will be used.
16137945|NCT01874379|Other|Standard of Care|Normal Procedures, no complementary medicine intervention.
16137946|NCT01874366|Drug|P11187|"Part I: Step wise dose escalation(10 to 1500 mg, qd, Oral)
~Part II: Step wise dose escalation in multiple dosing (≤ 1500 mg, qd, Oral) for 14 consecutive days.
~Part III: Study drug administered (≤ 1500 mg, qd, Oral) under fasted or fed conditions in two different periods separated by a wash-out interval."
16137947|NCT01874366|Drug|Placebo|"Placebo capsules will be matching in appearance with the active drug capsules of P11187.
~In Part I, there will be up to 6 cohorts of 8 subjects each in single dose assessment. Two subjects from each cohort will be dosed with placebo
~In Part II, there will be 3 cohorts of 12 subjects each and three subjects from each cohort will be dosed with placebo"
16137950|NCT01874340|Drug|Placebo|Placebo will be administered at predefined visits over the 6-month treatment phase.
16137951|NCT01874340|Drug|AIN457|AIN457 will be administered at predefined visits over the 6-month treatment phase.
16137952|NCT01874327|Behavioral|Baby JASPER|Intervention focuses on core deficits of joint attention, play, engagement, and regulation embedded within AEPS curriculum
16137953|NCT01874327|Behavioral|Standard Baby Classroom|Assessment, Education and Programming System (AEPS) for Infants and Children curriculum focused on early developmental milestones in fine and gross motor, cognitive, adaptive and social areas
16137954|NCT01874314|Drug|SQ109|300mg or 450mg of SQ109 administered orally, once daily for 7 days.
16137955|NCT01874314|Other|SQ109 Placebo|Placebo is a round, coated, yellow, unscored tablet. SQ109 Placebo administered orally, once daily for 7 days.
16137956|NCT01874314|Drug|Moxifloxacin|400mg of moxifloxacin (positive control) administered orally, once daily for 7 days.
16137957|NCT01874301|Other|High quantity probiotic|The intervention type is food product
16137958|NCT01874301|Other|Low quantity probiotic|The intervention type is food product
16137959|NCT01874301|Other|placebo|
16137960|NCT01874288|Drug|DI-Leu16-IL2|DI-Leu16-IL2 will be administered per dose and schedule specified in the arm.
16137961|NCT01874275|Device|VECTTOR|"The VT-200, or VECTTOR system, delivers electrical stimulation via electrodes on the acupuncture points of a patient's feet/legs and hands/arms to provide symptomatic relief of chronic intractable pain and/or management of post-surgical pain.
~Once these electrodes are placed, the machine determines the appropriate choice of stimulation by automatically measuring body temperatures through the use of thermistors placed on the fingers during a testing sequence."
16137962|NCT01874262|Device|Mobile-phone based patient support|The mobile-phone based patient support (investigational medical device) is a stand-alone software product used on the patients' own smart phone and used in addition to medical treatment.
16137963|NCT01874262|Device|e-diary|All patients (active and control group) participating in the study will report their daily use of ticagrelor in an e-diary which will be initiated on all study patients' smart phones.
16137964|NCT01874249|Other|Electronic detailed information|Electronic detailed information about non alcoholic fatty liver disease.
16137965|NCT01874249|Other|NAFLD Score|diagnosis of advanced fibrosis by NAFLD score, calculated according to Hepatology 2007;45(4):846-854
16137966|NCT01874249|Other|Transient elastography|Transient elastography values greater than 8 kPa
16137967|NCT01874236|Drug|0.75% bupivacaine|Week 1: SI joint injection with .75% bupivacaine Week 2: SI joint injection with .75% bupivacaine Week 3: SI joint sham block
16137968|NCT01874236|Drug|.75% bupivacaine|Week 1: SI join sham block Week 2: SI joint injection with .75% bupivacaine Week 3: SI joint injection with .75% bupivacaine
16137969|NCT01874236|Drug|.75% bupivacaine|Week 1: SI join injection with .75% bupivacaine Week 2: SI join sham block Week 3: SI joint injection with .75% bupivacaine
16137970|NCT01874197|Device|B-TEVAR device|Creation and implantation of the Branched Thorcoabdominal aortic anerysm device
16137971|NCT01874184|Other|counseling intervention|Take part in weekly group counseling sessions
16137972|NCT01874184|Behavioral|behavioral dietary intervention|Set goals for changing dietary habits
16137973|NCT01874184|Behavioral|exercise intervention|Attend group exercise activities
16137974|NCT01874184|Other|questionnaire administration|Ancillary studies
16137975|NCT01874184|Other|laboratory biomarker analysis|Correlative studies
16137976|NCT01874171|Drug|Cisplatin|
16137977|NCT01874171|Drug|Cetuximab|
16137978|NCT01874145|Drug|GA 20 mg/mL|Glatiramer acetate (GA) 20 mg/mL subcutaneous (SC) injection, the commercial product, is a single-use pre-filled syringe (PFS) containing 1.0 ml of a clear, colorless to slightly yellow, sterile, non-pyrogenic solution.
16137979|NCT01874145|Drug|GA 40 mg/mL|Glatiramer acetate (GA) 40 mg/mL subcutaneous (SC) injection, is a single-use pre-filled syringe (PFS) containing 1.0 ml of a clear, colorless to slightly yellow, sterile, non-pyrogenic solution.
16137980|NCT01874132|Behavioral|Exercise training|Both training programs were of moderate-to-vigorous intensity, three days per week for nine months.
16137981|NCT01874119|Drug|Fosaprepitant|During treatment admission, intravenous fosaprepitant 150 mg every 48 hours during 6-day hospital admission
16137982|NCT01874106|Other|Diet Therapy|The patients in this arm were educated to follow a especial type of diet (anti-inflammatory diet)in addition to nutrition counseling for 10 weeks.
16137983|NCT01874106|Other|Control Group|The patients in this arm received nutrition counseling and education in general based on their needs as a control group for 10 weeks.
16137984|NCT01874093|Device|The Ischemic Stroke System|SPG stimulation and standard of care
16137985|NCT01874093|Device|Sham control|Sham stimulation and standard of care
16137986|NCT01874080|Drug|Saxagliptin/Metformin|
16137987|NCT01874067|Device|Arthritis glove|Isotoner three-quarter finger arthritis glove
16137988|NCT01874054|Drug|brentuximab vedotin|1.8 mg/kg every 3 weeks by intravenous (IV) infusion
16137989|NCT01874054|Drug|bendamustine|90 mg/m2 on Days 1 and 2 of 3-week cycles
16137990|NCT01874041|Other|Massage|
16137991|NCT01874041|Other|Occlusal splint|
16137992|NCT01874028|Drug|trientine dihydrochloride|Patients will take their normal prescribed dose (x1) of trientine dihydrochloride 300mg
16137993|NCT01874015|Biological|mesenchymal cell transplantation|Mesenchymal cell transplantation in patients with Crohn's disease.
16137994|NCT01874015|Biological|mesenchymal cell and fibroblast injection|Transplantation of mesenchymal cell and fibroblast in patients with crohn's disease.
16137995|NCT01874002|Device|Combo stent|Percutaneous coronary intervention of patients with an indication for stent treatment with the COMBO stent, a stent with an endothelial progenitor cell attracting coating and abluminal sirolimus matrix. All consecutive patients treated with, or attempted treatment with, a COMBO stent are followed by telephone contact for 5 years.
16137996|NCT01873989|Drug|Testosterone replacement|
16137997|NCT01873989|Other|Waitlist control|
16137998|NCT01873950|Drug|Ranolazine|
16137999|NCT01873950|Drug|Dofetilide|
16138000|NCT01873950|Drug|Verapamil|
16138001|NCT01873950|Drug|Quinidine sulfate|
16138002|NCT01873950|Drug|Placebo|
16138003|NCT01873937|Radiation|Red LED|Phototherapy with red LED on temporomandibular area
16138004|NCT01873937|Radiation|INFRARED LED|Phototherapy with infrared LED on temporomandibular area
16138005|NCT01873937|Radiation|LASER|Phototherapy with LASER INFRARED on temporomandibular area
16138006|NCT01873898|Device|Rex Medical Closer™ Vascular Closure System|The Rex Medical CloserTM Vascular Closure System is currently being investigated for use in closing and reducing time to hemostasis at the femoral arterial puncture site in subjects who have undergone diagnostic angiography procedures or interventional procedures using up to a 7 French procedural sheath. This study will evaluate the safety and efficacy of the Rex Medical CloserTM Vascular Closure System to close the femoral artery access site of subjects who have undergone diagnostic angiography procedures with early ambulation and discharge as soon as possible after sheath removal and device placement.
16138007|NCT01873885|Drug|Placebo Single IV (Intravenous) Infusion|0.9% Sodium Chloride - 30 minute IV infusion
16138008|NCT01873885|Drug|Experimental: Single IV Infusion Vasomera (PB1046)|
16138009|NCT01873872|Dietary Supplement|Theralac probiotic|
16138010|NCT01873872|Dietary Supplement|Culturelle probiotic|
16138011|NCT01873872|Other|placebo|
16138012|NCT01873859|Drug|Metformin|Incidence of lactic acidosis in diabetic patients receiving contrast media in the presence of metformin.
16138013|NCT01873846|Device|Silicone Hydrogel Contact Lens|
16138014|NCT01873833|Drug|capecitabine|Given PO
16138015|NCT01873833|Drug|cyclophosphamide|Given PO
16138016|NCT01873833|Drug|lapatinib ditosylate|Given PO
16138017|NCT01873833|Biological|trastuzumab|Given IV
16138018|NCT01873833|Other|laboratory biomarker analysis|Correlative studies
16138019|NCT01873820|Dietary Supplement|Calcium ascorbate|
16138020|NCT01873820|Dietary Supplement|Ascorbic acid|
16138021|NCT01873807|Drug|IDA|Idarubicin: 15mg/m2/d: -8->-6d
16138022|NCT01873807|Radiation|TBI|TBI: 4.5 Gy/d, -5d, -4d
16138023|NCT01873807|Drug|CTX|CY:60mg/kg/d, -3d, -2d
16138024|NCT01873807|Drug|VP-16|VP-16: 15mg/kg, -2d, -1d
16138025|NCT01873794|Device|Bright white light|
16138026|NCT01873794|Device|Dim red light|
16138027|NCT01873781|Drug|Cyclopentolatehydrochloride|Cyclopentolatehydrochloride 0.5% (Thilo, Alcon, Vienna), dose: 1 drop for study eye
16138028|NCT01873768|Drug|Tranexamic Acid (TXA)|1g in 250cc of saline given over 30 minutes just prior to raising the tourniquet and making the initial incision. A second 1g in 250cc of saline will be infused over 30 minutes beginning at the time of wound closure.
16138029|NCT01873768|Drug|ε-Aminocaproic Acid (EACA)|7g in 250cc of saline given over 30 minutes just prior to raising the tourniquet and making the initial incision. A second 7g of EACA in 250cc saline will be infused over 30 minutes beginning at the time of wound closure.
16138030|NCT01873755|Behavioral|asthma physical activity intervention|School- and community-based intervention includes several components: a classroom-based physical activity program, asthma awareness week at the school, asthma education for parents and students enrolled in the study, collaboration with child's physician to ensure proper medical treatment of child's asthma asthma education for school personnel
16138031|NCT01873742|Other|STIC feedback system|This condition includes the use of the STIC feedback system.
16138032|NCT01873729|Drug|Naltrexone|Adults with ADHD
16138033|NCT01873716|Drug|Indocyanine green|Indocyanine green (ICG) for injection, 0.25mg/kg intravenously. A maximum of 25mg is given, approximately 30-60 minutes before carotid endarterectomy
16138034|NCT01873703|Drug|pracinostat|Histone deacetylase inhibitor (HDACi)
16138035|NCT01873703|Drug|Placebo|Placebo
16138036|NCT01873703|Drug|Azacitidine|Active comparator 75 mg/m2 Azacitidine for 7 days of each 28 day cycle, via subcutaneous (SC) injection or intravenous infusion if SC injections are intolerable
16138037|NCT01873690|Drug|Ciprofloxacin|Once, 400 mg IV
16138038|NCT01873690|Drug|Placebo|5% Dextrose in water
16138039|NCT01873677|Drug|M518101|
16138040|NCT01873677|Drug|Vehicle|
16138041|NCT01873664|Behavioral|Jaw-tapping|to tap their jaws vertically at 1.6 Hz at home twice a day for 30 seconds every day during four weeks.
16138042|NCT01873651|Device|Implantation of a Delta III Prosthesis|Implantation of a Delta III Prosthesis
16138043|NCT01873638|Procedure|Cholecystectomy|
16138044|NCT01873625|Biological|mesenchymal cell transplantation|Mesenchymal stem cell transplantation in patients with rheumatoid arthritis for resurfacing of articular cartilage of knee due to osteoarthritis.
16138045|NCT01873625|Biological|placebo|
16138046|NCT01873612|Procedure|Hypoxic ventilatory response|
16138047|NCT01873612|Procedure|Hypercapnic ventilatory response|
16138048|NCT01873599|Behavioral|Positive Affect Journaling|
16138049|NCT01873586|Procedure|Posterolateral Fusion|
16138050|NCT01873573|Procedure|Dilation|Dilation will be performed by either dilation balloons or over the wire polyvinyl dilators based upon the physician's discretion. Fluoroscopy may be used to aid in endoscopic dilation at the physician's discretion.
16138051|NCT01873573|Other|Triamcinolone Injection|Triamcinolone is a generic name of a long-acting synthetic corticosteroid and approved for sale in the United States by the U.S. Food and Drug Administration (FDA). After endoscopic dilation is performed, a total of 40-80 mg (physician preference) of triamcinolone (40 mg/ml) will be injected throughout the stricture under direct visualization.
16138052|NCT01873573|Procedure|Esophagogastroduodenoscopy (EGD)|EGD is a test to examine the lining of the esophagus (the tube that connects your throat to your stomach), stomach, and first part of the small intestine. It is done with a small camera (flexible endoscope) that is inserted down the throat.
16138053|NCT01873547|Biological|cell therapy|Mesenchymal stem cells derived from umbilical cord are transplanted directly into subarachnoid by Lumbar puncture.
16138054|NCT01873547|Other|rehabilitation|Patients only receive rehabilitation of limb function.
16138055|NCT01873534|Drug|FMX-8|FMX-8 is a fusion protein of the human hemojuvelin (HJV) protein.
16138056|NCT01873521|Procedure|Non invasive ventilation|
16138057|NCT01873508|Drug|RO4917523|Fast release MR capsule, single dose
16138058|NCT01873508|Drug|RO4917523|Target release MR capsule, single dose
16138059|NCT01873508|Drug|RO4917523|Slow release MR capsule, single dose
16138060|NCT01873508|Drug|RO4917523|[13C]-labeled tracer dose i.v.
16138061|NCT01873495|Drug|Omacetaxine|"Omacetaxine 1.25 mg/m² sub-cutaneously twice daily for 5 consecutive days every 28 (± 8) days for 3 cycles.
~Patients in continuous remission after 3 cycles of consolidation will receive maintenance omacetaxine 1.25 mg/m² twice daily for 3 days, every 28 days for up to 6 cycles"
16138062|NCT01873482|Behavioral|Movement to rhythm|Movement to rhythm
16138063|NCT01873469|Radiation|Radiochemotherapy|postoperative radiochemotherapy 60 Gy/ Temozolomide
16138064|NCT01873456|Other|multifactorial nutritional intervention|
16138065|NCT01873443|Drug|Rituximab, MTX, folic acid|Rituximab IV 1000mg MTX 10~25mg/week Folic acid at least 5mg/week
16138066|NCT01873430|Drug|Melatonin|
16138067|NCT01873417|Drug|BG00012 (DMF)|
16138068|NCT01873404|Drug|BG00010|As specified in the treatment arm
16138069|NCT01873404|Drug|Placebo|As specified in the treatment arm
16138070|NCT01873391|Procedure|Diagnostic hysteroscopy|
16138071|NCT01873378|Drug|Triptorelin 3.75 mg|
16138072|NCT01873365|Other|Data collection|Case report forms (CRFs), logbooks and booklets.
16138073|NCT01873352|Procedure|catheter ablation|Patient anesthesia will be administered according to standard EP lab protocol. Arterial and venous access will be achieved through cannulation of the right and/or left femoral arteries and veins as per the usual practice of the EP lab. Full systemic anticoagulation will be instituted as per standard hospital procedures to a target ACT of approximately 300 seconds or greater. Intravascular ultrasound may be used to assist in the positioning of study catheters during the procedure. The AF ablation procedure will be performed using a cryoballoon ablation catheter. Complete pulmonary vein isolation will be the goal of the ablation procedure and PV isolation must be confirmed by a multielectrode mapping catheter within each PV. Pulmonary vein isolation is the only intervention. A cavo-tricuspid isthmus line may be placed in patients with either a history of ECG-determined typical flutter or induced typical flutter during the procedure.
16138074|NCT01873352|Procedure|renal sympathetic denervation|Right or left femoral artery access. Real-time 3D aorta-renal artery maps constructed with the use of a navigation system and ablation catheter. Mapping and ablation performed after PVI and under identical sedation protocol used for AF ablation. RF delivery of 6 watts to be applied discretely from the first distal main renal artery bifurcation all the way back to the ostium; RF duration of each delivery 1.5 mins; lesions delivered at multiple sites based on multipolar catheter position within renal artery. Use of specifically designed RF delivery system for renal artery denervation is mandatory (RDN). To confirm renal denervation, high-frequency stimulation (HFS) will be applied before the initial and after each RF delivery within the renal artery. Rectangular electrical stimuli will be delivered at the ostium of the targeted renal artery at a frequency of 20 Hz, with an amplitude 15 V and pulse duration of 10 ms for 10 secs.
16138075|NCT01873339|Drug|Darapladib|The subjects will receive darapladib 160 mg once daily on Days 3-14. It is provided as Enteric coated, free base (micronized) 160 mg tablet.
16138076|NCT01873339|Drug|Midazolam|The subjects will receive a single oral dose of midazolam 5 mg on Day 1, 3 and14. It is provided as syrup. Each mL of syrup contains midazolam hydrochloride equivalent to 2 mg midazolam
16138077|NCT01873326|Drug|Paclitaxel|
16138078|NCT01873326|Drug|Ifosfamide|
16138079|NCT01873326|Drug|Cisplatin|
16138080|NCT01873326|Drug|Mesna|
16138081|NCT01873326|Drug|Bleomycin|
16138082|NCT01873326|Drug|Etoposide|
16138083|NCT01873313|Drug|Ropivacaine|
16138084|NCT01873300|Procedure|Endoscopic Esophageal Myotomy|Endoscopic mucosotomy, with submucosal tunneling and circular muscular fiber myotomy and mucosa closure.
16138085|NCT01873274|Dietary Supplement|MK-7 containing capsule|
16138086|NCT01873274|Dietary Supplement|basic yogurt enriched with MK-7|
16138087|NCT01873274|Dietary Supplement|nutrient-enriched yogurt with MK-7|
16138088|NCT01873248|Drug|68Ga-DOTATATE|68Ga-DOTATATE will be given in tracer doses and injected intravenously to image Neuroendocrine tumors by Positron Emission Tomography.
16138089|NCT01873222|Device|OFDI-guided PCI & IVUS|"Assessment by IVUS at post-PCI
~Assessment by OFDI at a 8-month follow-up"
16138090|NCT01873222|Device|IVUS-guided PCI & OFDI|"Assessment by OFDI at post-PCI
~Assessment by OFDI at a 8-month follow-up"
16138091|NCT01873196|Behavioral|Receive extra oil|
16138092|NCT01873196|Behavioral|Receives behavior changed messages on CSB package|
16138099|NCT01873157|Drug|Bortezomib|"Patients will receive two cycles of Bortezomib (Velcade®) at an interval of three months.
~Each cycle will consist of intravenously administered (within 3-5 seconds) Bortezomib 1.3 mg/m2 twice weekly on days 1, 4, 8 and 11."
16138100|NCT01873157|Drug|Placebo|"Patients will receive two cycles of Placebo (NaCl solution) at an interval of three months.
~Each cycle will consist of intravenously administered (within 3-5 seconds) Placebo twice weekly on days 1, 4, 8 and 11."
16138101|NCT01873144|Drug|Epinephrine 1/1000|Nebulization of 0.5 mL/kg (maximum 3 mL) of epinephrine 1/1000 every 4h for three times and afterwards at physician in charge criteria
16138102|NCT01873144|Drug|HSS 3%|Nebulization 2 mL of HSS (3%)+ epinephrine every 4h for three times and afterwards at physician in charge criteria
16138103|NCT01873144|Device|HHHFNC|Precision Flow (Vapotherm Inc. Stevensville, Maryland, US ) and RT329 (Fisher and Paykel Healthcare, Auckland, New Zealand) were the dispositive used depending on the availability. Fisher and Paykel nasal cannula was used in both devices, depending on age
16138104|NCT01873144|Drug|NS (0.9%)|Nebulization of 2 mL of NS (0.9%)+ epinephrine every 4h for three times and afterwards at physician in charge criteria
16138105|NCT01873131|Drug|topical timolol maleate|Timolol maleate 0.5% ophthalmic solution will be used. The dose will be 1 drop per square centimeter of hemangioma, rubbed into the area by the parent/guardian twice daily. The intent is to cover the entire lesion without excess of medication. Therefore, the dose can be lowered from 1 drop/cm2 at the discretion of the investigators, but not increased. This dose should not have significant systemic side effects given that the normal systemic intravenous dose for propanolol is 2mg/kg/day and there would be much less systemic absorption if the solution is applied topically. It is well established that the stratum corneum greatly slows the transport of timolol.
16138106|NCT01873131|Device|Pulsed dye laser|A 595-nm PDL (V-beam Perfecta, Candela Corp, Wayland, MA, USA) with a dynamic cooling device (DCD) will be utilized for all treatments. This device is cleared by the FDA for clinical treatment of vascular lesions. Protective eyewear for patient and all participants in the treatment room will be provided. A spot size of 7 or 10 mm will be used with an average fluence (energy delivered per unit area, in J/cm2) of 9 J/cm2 (range 8-10.0 J/cm2). Fluence will vary according to patient and hemangioma characteristics, including age, skin type, location, lesion thickness and response to treatment. A 30-50 ms cryogen spray cooling (CSC) duration will precede the laser pulse duration of 0.4 ms.
16138107|NCT01873118|Other|RN-RHDS protocol|The discharging nurse assesses each patient being discharged home using the Readiness for Hospital Discharge Scale (RN version)
16138108|NCT01873118|Other|RN-RHDS+PT-RHDS protocol|The discharging nurse obtains and reviews patient self-report of discharge readiness using the Readiness for Hospital Discharge Scale - Patient version and then completes the Readiness for Hospital Discharge Scale (RN version)
16138109|NCT01873118|Other|RN-RHDS + PT-RHDS + NIAF|The discharging nurse assesses each patient being discharged home using the Readiness for Hospital Discharge Scale (RN version)after reviewing the patients self-perception of discharge readiness (PT-RHDS) and then records any actions taken in response to the discharge readiness assessment on the Nurse Initiated Action form (NIAF). When any item on the RN-RHDS is less than 7, an action is required.
16138110|NCT01873105|Other|Health Team Educational Intervention|AHRQ TeamStepps processes will be used to redesign health team discharge communication processes and an educational intervention for health care team members
16138111|NCT01873079|Drug|Esomeprazole|
16138112|NCT01873079|Other|Standard care|No PPI or other study medication given
16138113|NCT01873066|Device|Closed-loop system|The closed-loop system is purpose-built and comprises a hand-held computer containing a model predictive control (MPC) based glucose control algorithm and communicating with the CGM device and the insulin pump.
16138114|NCT01873066|Device|real-time CGM|Subject's glucose level is controlled by usual insulin pump therapy in conjunction with real time continuous glucose monitoring (CGM)
16138115|NCT01873053|Drug|WIN-34B|Patients assigned to Experimental group(1st or 2nd group) take WIN-34B 450mg or WIN-34B 900mg BID for 12weeks
16138116|NCT01873053|Drug|Placebo|
16138117|NCT01873040|Behavioral|Social Media plus information pages|Participants will receive access to the study vaccine website information pages and social media feature including blogs, discussion forums, expert chats, and ask an expert.
16138118|NCT01873040|Behavioral|Vaccine Information Pages|Participants will receive access to the study vaccine website information pages.
16138119|NCT01873027|Device|OFDI|"OFDI-guided PCI and assessment by OFDI at pre-PCI and post-PCI
~Follow-up contact at the time of hospital discharge, 8 months and 12months after PCI"
16138120|NCT01873027|Device|IVUS|"IVUS-guided PCI and assessment by IVUS at pre-PCI and post-PCI
~Follow-up contact at the time of hospital discharge, 8 months and 12months after PCI"
16138121|NCT01873014|Drug|chinese herbs-I|two agent per day, twice a day
16138122|NCT01873014|Drug|chinese herbs-II|two agent per day, twice a day
16138123|NCT01873001|Drug|Pioglitazone HCl|15 mg tablet administered by mouth on Day 1, and Day 8 1 hour after study drug administration
16138124|NCT01873001|Drug|Abiraterone acetate|1000 mg tablets administered by mouth on Day 8
16138125|NCT01872988|Drug|Tenofovir|Administer Tenofovir to HCC patients who are indicated for TACE after randomization
16138126|NCT01872988|Drug|Placebo|Administer Placebo to HCC patients who are indicated for TACE after randomization
16138127|NCT01872975|Radiation|regional nodal XRT|
16138128|NCT01872975|Radiation|chestwall XRT|
16138129|NCT01872975|Radiation|WBI|
16138130|NCT01872962|Drug|gemcitabine and cisplatin (Induction chemotherapy)|Patients receive gemcitabine (1000 mg/m² d1,8) and cisplatin (80mg/m² d1) every 3 weeks for 3 cycles before concurrent chemoradiotherapy.
16138131|NCT01872962|Radiation|IMRT and concurrent cisplatin|Intensity modulated-radiotherapy (IMRT) is given as 2.0-2.30 Gy per fraction with five daily fractions per week for 6-7 weeks to a total dose of 66 Gy or greater to the primary tumor, concurrently with cisplatin 100 mg/m² every 3 weeks for 3 cycles.
16138132|NCT01872936|Drug|Miravirsen|
16138133|NCT01872936|Drug|Telaprevir|
16138134|NCT01872936|Drug|Ribavirin|
16138135|NCT01872923|Drug|Amphinex|Photosensitiser
16138136|NCT01872923|Drug|Bleomycin|Anticancer agent
16138137|NCT01872923|Device|Laser|Laser that emits red light at 652 nm.
16138138|NCT01872910|Drug|Placebo|Administered orally
16138139|NCT01872910|Drug|LY3023703|Administered orally
16138141|NCT01872897|Drug|Sodium Alginate Double Action Tablets|Four tablets as a single dose
16138142|NCT01872897|Drug|Placebo|4 tablets as a single dose
16138143|NCT01872884|Drug|Sevorane Remifentanil|Sevorane Remifentanil
16138144|NCT01872884|Drug|Remifentanil|Remifentanil
16138145|NCT01872871|Drug|Paracetamol|paracetamol with local anesthetic eye drop versus placebo with local anesthetic eye drops
16138146|NCT01872871|Drug|Topical anaesthetic drop with placebo|
16138147|NCT01872858|Drug|Aspirin|Aspirin, 100mg, Q.D, p.o, 2yr
16138148|NCT01872858|Drug|Cilostazol|cilostazol, 100mg, B.I.D, p.o, 2yr
16138149|NCT01872845|Drug|Pravastatin 40mg|Pravastatin 40mg PO daily for 1year from the day of BES implantation
16138150|NCT01872845|Drug|Rosuvastatin|Rosuvastatin 20mg PO daily for 1year from the day of BES implantation
16138151|NCT01872832|Drug|RDEA3170 and Placebo|
16138152|NCT01872819|Other|antitumor drug screening assay|Undergo high throughput drug sensitivity assay
16138153|NCT01872819|Drug|chemotherapy|Patients receive 1 of 160 possible interventions
16138154|NCT01872819|Biological|biological therapy|Patients receive 1 of 160 possible interventions
16138155|NCT01872806|Radiation|a dialing smartphone will be placed on the chest and the ear|
16138156|NCT01872780|Drug|Rosiglitazone|single oral administration of 4mg of rosiglitazone
16138157|NCT01872780|Genetic|CYP2C8 genotype|CYP2C8*11.
16138158|NCT01872754|Drug|1: Remifentanil|1: Remifentanil group The infusion of Remifentanil by TCI begins at distance from the introduction of fiberoptic. The effect site target is 4 ng / ml.- A titration in increments or decrements (respectively increase or decrease of 1 ng / ml effect site concentration) separated by 1 minute intervals until an OAAS score of 4 and respiratory frequency range between 10 and 20 cycles per minute.
16138159|NCT01872754|Drug|2: Propofol|2: Propofol group- The infusion of Propofol by TCI begins at distance from the introduction of fiberoptic. The effect site target is 2,5 ng / ml.- A titration in increments or decrements (respectively increase or decrease of 0.5 mg / ml concentration effect site) separated by 1 minute intervals until an OAAS score of 4 and included respiratory rate between 10 and 20 cycles per minute.
16138160|NCT01872741|Procedure|Minipterional craniotomy|Minipterional craniotomy approach for ruptured and unruptured aneurysms
16138161|NCT01872741|Procedure|Pterional craniotomy|Pterional craniotomy approach for ruptured and unruptured aneurysm
16138162|NCT01872728|Drug|Bilateral facial block after general anesthesia before surgery|Bilateral facial block (infraorbital and infratrochlear) after general anesthesia before surgery with intravenous placebo or bilateral block with placebo and intravenous morphine
16138163|NCT01872715|Drug|Oracea|
16138164|NCT01872702|Drug|malaria elimination using DP and low-dose primaquine|Treatment of all persons resident in the intervention villages including those who do not have malaria parasites as detected by rapid diagnostic test. This is to interrupt p.f malaria transmission by removing the reservoir of all potentially infectious people from the area.
16138165|NCT01872689|Drug|Lebrikizumab|Lebrikizumab will be administered at a dose of 250 mg via SC injection once every 4 weeks.
16138166|NCT01872689|Drug|Pirfenidone|Pirfenidone will be administered orally at a stable dose of 2403 mg per day or at MTD.
16138167|NCT01872689|Drug|Placebo|Placebo matched to lebrikizumab will be administered via SC injection once every 4 weeks.
16138168|NCT01872676|Other|Spine manipulation|
16138169|NCT01872676|Other|Manipulation sham|
16138170|NCT01872663|Procedure|Continuous positive airway pressure|The use of positive pressure airway seeking the prevention or treatment of hypoxic respiratory failure, improved arterial oxygenation, restoration or maintenance of lung volume reduction and atelectasis, decrease the work of breathing, decreased dyspnea index and increased residual volume.
16138171|NCT01872663|Procedure|Incentive spirometry|The volume of incentive spirometry (Voldyne ®) is able to provide increased transpulmonary pressure gradient, which can prevent or reverse atelectasis.
16138172|NCT01872663|Procedure|Breath Stacking|The method allowed to obtain a maximum lung expansion with minimal patient compliance.
16138173|NCT01872663|Procedure|Expiratory Positive Airway Pressure|The use of positive pressure airway seeking the prevention or treatment of hypoxic respiratory failure, improved arterial oxygenation, restoration or maintenance of lung volume reduction and atelectasis, decrease the work of breathing, decreased dyspnea index and increased residual volume.
16138174|NCT01872663|Procedure|Intermittent positive pressure breathing|The use of positive pressure airway seeking the prevention or treatment of hypoxic respiratory failure, improved arterial oxygenation, restoration or maintenance of lung volume reduction and atelectasis, decrease the work of breathing, decreased dyspnea index and increased residual volume.
16138175|NCT01872663|Procedure|Bi-level positive airway pressure|The use of positive pressure airway seeking the prevention or treatment of hypoxic respiratory failure, improved arterial oxygenation, restoration or maintenance of lung volume reduction and atelectasis, decrease the work of breathing, decreased dyspnea index and increased residual volume.
16138176|NCT01872650|Device|C-Qur|In subjects assigned to the treatment arm, the C-Qur™ Film must be applied beneath the incision. The C-Qur™ film can also be applied to other areas considered to be adhesiogenic (e.g. the dissection site and ostomy site but not around the anastomosis). The number of C-Qur™ Film sheets placed is limited to a maximum area of coverage of 774cm2.
16138177|NCT01872637|Behavioral|Progressive Multi-Component Intervention|
16138178|NCT01872637|Behavioral|Usual Care|
16138179|NCT01872624|Procedure|Bronchoscopy|Bronchoscopic delivery of one-way valves and bone-marrow derived mesenchymal stromal cells.
16138180|NCT01872611|Drug|Nepafenac Ophthalmic Suspension, 0.3%|
16138181|NCT01872611|Other|Vehicle|Inactive ingredients used as placebo comparator
16138182|NCT01872611|Drug|Prednisolone acetate|1 drop instilled in the operative eye 4 times daily beginning post-operatively on the day of surgery for the first 2 weeks, followed by 2 times daily for the next 2 weeks
16138183|NCT01872598|Drug|Masitinib|
16138184|NCT01872598|Drug|Placebo|
16138296|NCT01871688|Behavioral|pelvic floor rehabilitation program with neuromodulation|pelvic floor rehabilitation program with neuromodulation
16138297|NCT01871675|Drug|IPI-145|
16138298|NCT01871675|Drug|Rituximab|
16138299|NCT01871675|Drug|Bendamustine|
16140067|NCT01858246|Device|Bonebridge|
16138185|NCT01872585|Behavioral|Mentalization based therapy|12-24 weekly 1 hour individual therapy sessions with Masters level therapists who are trained and supervised by Dr. Suchman (the Principal Investigator) in the Parenting from the Inside Out approach. The broad goals of the program are to help prevent the onset of substance abuse and psychiatric disorders, promote adaptive interpersonal relationships and social-emotional functioning in caregivers and their children, and help prevent the transmission of psychiatric illness across generations
16138186|NCT01872572|Drug|Subcutaneous RB006 0.5 mg/kg|Subcutaneous RB006 0.5 mg/kg
16138187|NCT01872572|Drug|Subcutaneous RB006 1.0 mg/kg|Subcutaneous RB006 1.0 mg/kg
16138188|NCT01872572|Drug|Subcutaneous RB006 3.0 mg/kg|Subcutaneous RB006 3.0 mg/kg
16138189|NCT01872572|Drug|Subcutaneous RB006 2.0 mg|"Arm 1: 4 subjects received an IV bolus injection of 1 mg/kg RB007 at 72 hours post-RB006 administration
~Arm 2: 4 subjects received an IV bolus injection of 1 mg/kg RB007 at 24, 72, and 120 hours post-RB006 administration."
16138190|NCT01872572|Drug|Placebo|Placebo
16138191|NCT01872559|Other|3D Sonography analysis|Those patients who are scheduled to have an ultrasound as part of their infertility treatment will be offered the opportunity to have additional measurements done at the time of their ultrasound; these additional measurements will take less than 2 minutes and do not require any additional sonograms, tests, or interventions.
16138192|NCT01872546|Drug|HUMIRA 40mg|
16138193|NCT01872533|Other|Hypoxia Exposure|Participants spent 10 consecutive nights (approximately 100 hours of exposure) in a hypoxic tent at ~ 15% O2 (ca. 2400 m elevation).
16138194|NCT01872507|Other|Biofeedback training|usual treatment +12 biofeedback training
16138195|NCT01872494|Other|local|This group uses local analgesia infusion pump of 0.33% ropivacaine 250ml through the wound for postoperative analgesia.
16138196|NCT01872494|Other|intravenous|This group is treated with intravenous analgesia pump infusion of flurbiprofen axetil 150mg,palonosetron 0.5mg,pentazocine 240mg.
16138197|NCT01872494|Drug|0.33% ropivacaine 250ml|
16138198|NCT01872494|Drug|flurbiprofen axetil 150mg,palonosetron 0.5mg,pentazocine 240mg.|
16138199|NCT01872481|Device|rTMS|rTMS in series of 20 trains of 6 s in duration (54-s intertrain interval) at a stimulation rate of 10 Hz (1200 pulses) at an intensity of 90% rest motor threshold. Sessions will be administered 5 days a week (Monday to Friday) during two consecutive weeks.
16138200|NCT01872481|Device|Sham rTMS|A coil with similar appearance to the active coil in shape and weight, producing a similar sound artifact but without emission of a magnetic pulse is used for the control group.
16138201|NCT01872468|Behavioral|Structured intervention|Initial training session based on patient personal experiences and reflexion (30 minutes). CKD learning session (30 minutes). Personal plan of actions to cope with own disease (30 minutes. Discussion of doubts (30 minutes). Follow up visits every four months at physicians and nurses´ offices over a two-year period
16138202|NCT01872455|Dietary Supplement|n-3 rich diet|This dietary plan included seafood (salmon, sardines, herrings, and bluefish) and specific fruits and vegetables (oranges, strawberries, cherries, bananas, courgettes, artichokes, mushrooms, cauliflowers and pumpkins). Olive oil, rich in monounsaturated fats, was also included in the dietary plan. Patients were encouraged to use n-3 rich margarine as additional source of fatty acids. According to the data of the manufacturer, the fatty acid composition of this margarine was 3.4 mg of n-3 and 7.8 mg of n-6 per 100 g of weight. To keep n-6 PUFA intake low, patients were also requested to eat less eggs, meat, whole grains and cereals. All the components of the diet were fresh foods, with the exception of salmon and herrings that could also be preserved. Because no change in body weight was requested, patients maintained the same energy and protein intake of the diet that they assumed before entering the study.
16138203|NCT01872455|Dietary Supplement|Usual diet|Usual diet of the patients
16138204|NCT01872442|Drug|Dasatinib|"Dasatinib 100mg daily starting at inclusion
~If ANC ≤ 1.5.109/L, platelets ≤ 100.0.109/L or lymphocytes > 4.0.109/L at 3 months, dasatinib will be continued alone, and patients will be still followed in the study"
16138205|NCT01872442|Drug|Peg-Interferon alpha2b|30 µg weekly starting month 4- month 21
16138206|NCT01872416|Device|Liposomal Doxorubicin Combined With ifosfamide|Liposomal Doxorubicin Combined With ifosfamide Second-line Treatment in Small Cell Lung Cancer
16138207|NCT01872403|Drug|nanoparticle albumin-bound paclitaxel/carboplatin|Neoadjuvant chemotherapy of nanoparticle albumin-bound paclitaxel/carboplatin vs. paclitaxel /carboplatin in stage Ⅱ B and IIIA squamous cell carcinoma of the lung:
16138208|NCT01872390|Other|Combination Intervention Package|CIP will contain programmatic, structural and psychosocial components including: 1) nurse training and mentorship in TB/HIV cotreatment using a clinical algorithm; 2) reimbursement of transportation costs to monthly clinic visits for patients and treatment supporters; 3) health education using a TB and HIV treatment literacy curriculum for patients and treatment supporters; and 4) real-time adherence support using short message service (SMS) text messaging and trained village health workers (VHW). These components were selected for their promise, practicality, and feasibility of implementation and scale-up in HIV programs in diverse settings - in addition to SOC.
16138209|NCT01872390|Other|Standard of Care|Usual procedures for management of HIV-infected TB patients will be followed: Three I's training, ART provision to TB patients in integrated clinics, and treatment supporter for TB treatment.
16138210|NCT01872377|Radiation|CyberKnife® Stereotactic Body Radiotherapy(SBRT)Boost|Stereotactic body radiotherapy (SBRT) is a minimally invasive treatment technique that allows for ultra-high doses of radiation to be delivered to small areas with precision. In this study all participants will receive one of 5 dose levels that will be assigned according to Time-to-Event Continual Reassessment Method (TITE-CRM). Three fractions of various dose levels would be delivered over 5 to 10 days (typically Monday, Wednesday and Friday) with at least 36 hours between two sessions. In case of technical or medical problem, the authorized total treatment time is 12 days.
16138211|NCT01872351|Drug|Nutraceuticals|
16138212|NCT01872338|Behavioral|Mindfulness-Based Cognitive Therapy for Suicide|Psychotherapeutic intervention that integrates mindfulness meditation with Safety Planning, with a specific focus on reducing suicide risk.
16138213|NCT01872338|Behavioral|Treatment as usual|VA standard care for suicide prevention
16138300|NCT01871662|Drug|Legalon® SIL (Silibinin)|Silibinin 20 mg/Kg/day
16138301|NCT01871662|Drug|Pegylated interferon alfa2b|1.5 µg/kg once-weekly
16138302|NCT01871662|Drug|Ribavirin|At weight-based dose 800-1400 mg/day (BID, OS)
16138214|NCT01872325|Behavioral|Education|An education program will be developed using behaviour change techniques specifically mapped to address modifiable factors identified in a previous study. These techniques will include: information about the significance of agonal breathing, modeling/demonstration of desired behavioural skills, rehearsal of desired skills, and monitoring/reinforcement and feedback.
16138215|NCT01872312|Device|treatment with valves (The Spiration® IBV Valve System)|treat BPF
16138216|NCT01872286|Device|AKE-1|
16138217|NCT01872286|Device|Pillcam SB2|
16138218|NCT01872273|Other|Moderate Physical Exercise|This intervention is comprised of two separate visits at least one week apart. The purpose of visit 1 is to determine the cycle ergometer workload that produces a moderate exercise intensity of 60% heart rate reserve to be used on visit 2. The purpose of visit 2 is to determine changes in platelet reactivity in response to moderate exercise.
16138222|NCT01872234|Device|Two-lead CRT-P|The two lead CRT-P will consist of a dual chamber pacemaker, a right atrial lead and a left ventricular lead.
16138223|NCT01872221|Procedure|Surgery (based on preoperative multimodal MRI) followed by the standard radio-chemotherapy stupp protocol|
16138224|NCT01872208|Device|HAVG graft implantation|Patients will be implanted with a Human Acellular Vascular Graft (HAVG) as an above-knee femoro-popliteal bypass graft using standard vascular surgical techniques. The graft will be placed in a straight or curved configuration.
16138225|NCT01872195|Other|The comprehensive patient safety checklist system|The comprehensive patient safety checklist system follows each patient from admission to discharge with separate short checklists at each point of care: On admission to the hospital and ward (operating theatre nurse, ward doctor, surgeon, anaesthesiologist, ward nurse - 5 lists), in the operating theatre (here covered by the WHO-Safe Surgery checklist), at the recovery/ICU unit (nurse- 1 list), at discharge from the hospital (ward doctor, ward nurse - 2 lists).
16138226|NCT01872182|Drug|ALS-L1023|daily twice for 12 weeks
16138227|NCT01872182|Drug|placebo|daily twice for 12 weeks
16138228|NCT01872169|Other|Disordered eating screening questionnaire|
16138229|NCT01872156|Other|Intervention GESTABAC|"Intervention based on the Clinician's Guide to helping Pregnant Women Quit Smoking on the rates of abstinence of the patients in whom it has been controlled in this period of time, at the end of the pregnancy and after the childbirth."
16138230|NCT01872156|Other|Control Group|The group control will act according to usual management.
16138231|NCT01872143|Device|transcranial Direct Current Stimulation|daily or twice-a-day administration of transcranial Direct Current Stimulation from a minimum of 10 session to a maximum of 20
16138232|NCT01872117|Other|Shortwave therapy|Will be conducted in four stages, on different days: i) lower limb in extension and application of 180° for 20 min, ii) Lower limb knee flexion of 90° and application for 20 min; iii) lower limb extension in 180° without application iv) lower limb knee flexion of 90° without application.
16138233|NCT01872117|Other|Microwave therapy|Will be held in two stages, on different days: i) lower limb in extension with angle of 180° and application for 20 min, ii) lower limb in extension of 180° without application.
16138234|NCT01872104|Procedure|Photodynamic therapy|Each patient to whom PDT was offered underwent a specific, detailed educational process by a dedicated team member(P.B., P.J., or K.E.), after which informed consent was obtained.Porfimer sodium (Photofrin; Axcan Pharma Inc, Quebec, Canada)was used as a photo sensitizing agent, administered intravenously at a dose of 2 mg/kg body weight 48 hours before illumination.A diode laser system (InGaAIP Laser Diode; Diomed Inc, An-dover, MA) with a maximum power output of 2000 mW and a wavelength of 633+-3 nm was used as a light source, delivered through a 3.0-m length fiber having a 2.5-cm-long cylindrical diffuser at its distal end (Pioneer Optics, Windsor Locks, CT).
16138235|NCT01872091|Other|cryotherapy by immersion|
16138236|NCT01872091|Other|Control group|
16138237|NCT01872078|Drug|AZD4901 (oral)|Patients randomized to 1 of 4 treatment groups: AZD4901 20 mg once a day, AZD4901 20 mg twice a day, AZD4901 40 mg twice a day or placebo
16138238|NCT01872078|Drug|Placebo to match AZD4901|Patients randomized to 1 of 4 treatment groups: AZD4901 20 mg once a day, AZD4901 20 mg twice a day, AZD4901 40 mg twice a day or placebo
16138239|NCT01872065|Drug|ARC-520|
16138240|NCT01872065|Drug|Placebo|
16138241|NCT01872052|Device|Acutus Medical System Mapping|Mapping with the Acutus Medical System followed by intracardiac ablation of typical atrial flutter
16138242|NCT01872039|Drug|Perdipine injection|IV
16138243|NCT01872026|Drug|ASP7991|oral
16138244|NCT01872013|Drug|ASP7991|oral
16138245|NCT01872013|Drug|Placebo|oral
16138246|NCT01872000|Procedure|Cataract surgery|
16138247|NCT01871987|Drug|FK949E|oral
16138248|NCT01871974|Drug|FK949E|oral
16138249|NCT01871961|Drug|Methotrexate (Metoject® prefilled pen)|
16138250|NCT01871948|Other|"We Want to Know campaign, Patient survey at 2 time points"|Randomly assigned patients attending cancer clinics at Washington or Georgia sites during February 2013 to August 2013 will be presented with or mailed a survey about cancer communication approximately 2 weeks later and a follow-up survey approximately 3 months later. Additionally, this group will also receive a follow-up phone call approximately 4 weeks after baseline survey.
16138251|NCT01871935|Drug|Remifentanil|Anaesthesia with remifentanil/propofol.
16138252|NCT01871935|Drug|Sufentanil|Anaesthesia with sufentanil/propofol
16138253|NCT01871922|Drug|Placebo|Saline
16138254|NCT01871922|Drug|Atropine|Atropine
16138255|NCT01871896|Device|Endoscopic Suturing to Create Early Satiety|Evaluating the efficacy of endoscopic suturing for weight loss.
16138256|NCT01871883|Procedure|Skin biopsy|Two skin biopsies will be taken with a 3 mm punch in the retroauricular area. The procedure will be done by an investigator, under aseptic and antiseptic conditions and under local anesthesia with lidocaine and epinephrine. The incision will be sutured with 6-0 Nylon, and the stitches will be removed after 5 days. One biopsy will be processed for immunohistochemistry, the other for RNA extraction and analysis.
16138303|NCT01871649|Drug|golimumab|golimumab 50mg subcutaneous injections (in combination with methotrexate), once a month, for a period of 22 weeks
16138257|NCT01871883|Procedure|Oral mucosa specimen|The sample for keratinocytes from oral mucosa will be taken with a Foam knife, which is a non-invasive procedure. It does not need anesthesia, and it does not leave scars. The procedure consists in gently brush the oral mucosa with the knife five times, and the material that will be obtained will be fixed in a PBS solution for RNA analysis.
16138258|NCT01871870|Device|Artificial Pancreas Control Software|This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an outpatient automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm programmed into a smart phone.
16138259|NCT01871857|Drug|Hypertonic saline and epinephrine|
16138260|NCT01871857|Drug|Normal saline and epinephrine|
16138261|NCT01871844|Drug|ITF2984 (500, 1000, 2000 mcg bid for 7 days)|
16138262|NCT01871844|Drug|octreotide 50 mcg tid|
16138263|NCT01871844|Drug|Placebo|
16138264|NCT01871831|Device|6 blood glucose monitoring systems for self-testing|
16138265|NCT01871818|Behavioral|Combined program|Combined program with physiotherapy, endurance training and resistance training
16138266|NCT01871818|Behavioral|Physiotherapy in private practice|Physiotherapy in private practice
16138267|NCT01871805|Drug|Alectinib|Participants will receive alectinib as described in the arm descriptions.
16138268|NCT01871792|Drug|Pitavastatin|
16138269|NCT01871792|Drug|Placebo|Sugar pill manufactured to mimic Pitavastatin 4 mg tablet
16138270|NCT01871779|Other|Standard Treadmill Exercise|Standard treadmill exercise to the point of pain twice weekly for 35-45 minutes for 12 weeks
16138271|NCT01871779|Other|Intermittent treadmill & resistance training|Combination of standard treadmill training and resistance training with weights twice weekly for 12 weeks
16138272|NCT01871766|Drug|Vincristine|"Dosage and route of administration:
~< 1 year of age=0.025 mg/kg intravenously (IV)
~> 1 year and < 3 years= 0.05 mg/kg IV
~≥ 3 years=1.5 mg/m^2 IV. Maximum dose 2 mg in all participants."
16138273|NCT01871766|Drug|Dactinomycin|"Dosage and route of administration:
~< 1 year=0.025 mg/kg IV push
~≥ 1 year=0.045 mg/kg IV push over 1 to 5 minutes."
16138274|NCT01871766|Drug|Cyclophosphamide|"Dosage and route of administration:
~During VAC chemotherapy:
~< 3 years of age = 40 mg/kg IV
~≥ 3 years of age = 1200 mg/m^2 IV, with MESNA.
~During maintenance for intermediate-risk participants:
~oral cyclophosphamide 50 mg/m^2/dose/day (liquid or tablet)"
16138275|NCT01871766|Procedure|Surgical Resection|Surgery will be performed for the primary site tumor with the goal of removing tumor cells while maintaining function in the organ or adjacent organs involved.
16138276|NCT01871766|Procedure|Radiation|Radiation therapy will be delivered at approximately week 13 (intermediate risk) or week 19 (high risk) after initiation of chemotherapy. Certain patients will receive radiation at week 4.
16138277|NCT01871766|Drug|Bevacizumab|Dosage and route of administration: 15 mg/kg/dose/day IV.
16138278|NCT01871766|Drug|Sorafenib|Dosage and route of administration: 90 mg/m^2/dose twice daily.
16138279|NCT01871766|Drug|Myeloid Growth Factor|"If a participant's chemotherapy has been delayed or modified for hematologic toxicity, or if participant experiences a significant life-threatening toxicity due to bone marrow suppression, myeloid growth factor (either filgrastim or peg-filgrastim) will be given per institutional practice.
~High Risk participants receive filgrastim 5 micrograms/kg/day (maximum 300 micrograms) subcutaneously beginning 24-36 hours after the last dose of chemotherapy. Continue at least 7 days, or until the ANC ≥750/µL whichever comes last. Sargramostim or peg-filgrastim may not be used."
16138280|NCT01871766|Procedure|Lymph Node Sampling|"Clinical and/or imaging evaluation of regional lymph nodes will be conducted pretreatment and preoperatively as part of staging. This will aid in determining the efficacy of this procedure in defining involved lymphatics in at risk patients."
16138281|NCT01871766|Drug|Irinotecan|Dosage and Route Administration: During interval compressed therapy - irinotecan 50mg/m^2 IV (maximum dose 100 mg/day) daily x 5.
16138282|NCT01871766|Drug|Ifosfamide|Dosage and Route of Administration: During interval compressed therapy - Age > 1 year: 1800 mg/m^2/day IV x 5 Age <1 year: treat with 50% doses calculated on a m^2 basis.
16138283|NCT01871766|Drug|Etoposide|"Dosage and Route of Administration:
~Age >1 year 100 mg/m^2/day IV x 5 Age < 1 year treat with 50% doses calculated on a m^2 basis"
16138284|NCT01871766|Drug|Etoposide Phosphate|Dosage and Route of Administration: Used in substitution for etoposide in participants who experience allergic reaction. It will be administered 100 mg/m^2/day IV.
16138285|NCT01871766|Drug|Doxorubicin|"Dosage and route of Administration:
~Age ≥1 year, 37.5 mg/m^2 IV over 1 hour x 2 days Age <1 year, 18.75 mg/m^2 (i.e., a 50% dose reduction) IV over 1 hour x 2 days."
16138286|NCT01871766|Drug|Dexrazoxane|"Dosage and Route of Administration: Dexrazoxane dose should be 10x that of doxorubicin.
~Age ≥1 year, 375 mg/m^2 IV over 15-30 minutes Age <1 year, 187l.5 mg/m^2 (i.e., a 50% dose reduction) IV over 15-30 minutes."
16138287|NCT01871766|Drug|^1^1C-methionine|Participants receive ^1^1C-methionine to relate the distribution, intensity and change in ^1^1C-methionine CTPET imaging of the primary site to tumor control and patient outcome.
16138288|NCT01871753|Other|Anti-Infective Agents|10 days of antibiotics, started and selected according to the antibiogram results. In case of reinfection or relapse, re-administration of antimicrobial agents will be performed according to the antibiogram results (for a maximum of 3 cycles of ten days of antibiotics during the 12 months of the follow-up)
16138289|NCT01871740|Drug|Enalapril maleate and folic acid tablets|Enalapril maleate and folic acid tablets, (10mg/0.8mg)/tablet, taken orally and once daily for a maximum of 5 years. Combination with other anti-hypertension drugs are allowed.
16138290|NCT01871740|Drug|Enalapril maleate|Enalapril, 10mg/tablet, taken orally once daily for a maximum of 5 consecutive years. Combination with other anti-hypertension drugs are allowed.
16138292|NCT01871701|Drug|Escitalopram|Escitalopram
16138293|NCT01871701|Drug|Quetiapine|Quetiapine
16138294|NCT01871701|Drug|Moxifloxacin|Moxifloxacin
16138295|NCT01871701|Other|Placebo|Placebo
16138387|NCT01870973|Procedure|no root canal treatment, anesthesia, pain medications, and antibiotic|
16138304|NCT01871649|Drug|methotrexate|Methotrexate will be started at a dosage of 15 mg/week orally and, if well tolerated, increased to 20mg/week at week 4 and 25mg/week at week 8 of the trial. If well tolerated, the maximum dose of 25 mg/week will be sustained until end of study (week 50). Folic acid 5 mg/week will be administered orally one day after the MTX intake.
16138305|NCT01871636|Procedure|Endoscopic mucosal resection|Endoscopic mucosal resection removes tissue in a piece meal technique or by snare limited to the mucosa.
16138306|NCT01871636|Procedure|Waterjet-assisted ESD|The waterjet-assisted endoscopic submucosal dissection (WESD) technology allows pressure controlled injection of fluids through the tip of a recently developed HybridKnife®. Submucosal injection, circumferential cutting and dissection of lesions.
16138307|NCT01871636|Device|HybridKnife|The waterjet-assisted endoscopic submucosal dissection (WESD) technology allows pressure controlled injection of fluids through the tip of a recently developed HybridKnife®. Submucosal injection, circumferential cutting and dissection of lesions.
16138308|NCT01871623|Procedure|Segmental Le Fort I osteotomy|comparison the stability of segmental Le Fort I osteotomy with conventional approach of one-piece Le Fort I osteotomy
16138309|NCT01871623|Procedure|One-piece Le Fort I Osteotomy|conventional approach
16138310|NCT01871610|Drug|[18F]AV-45 PET amyloid binding imaging|
16138311|NCT01871597|Device|Pulmonary Artery Energy Seal|Pulmonary artery energy seal devices such as: Ligasure, Harmonic scalpel, Enseal, Thunderbeat, Unipolar and Conventional bipolar Cautery, metal clip or Hem-o-lok clip will be used to seal the artery(ies)
16138312|NCT01871584|Device|Colon cleansing by hydrotherapy|The Angel of Water™ system will be used for hydrotherapy of the colon in adult subjects scheduled for elective colonoscopy.
16138318|NCT01871558|Drug|Vildagliptin|50 mg b.i.d
16138319|NCT01871558|Drug|Metformin|metformin is to be kept unchanged
16138320|NCT01871558|Drug|sulfonylurea (SU)|
16138321|NCT01871558|Drug|Basal Insulin|
16138322|NCT01871545|Device|Magnetic Resonance Imaging|Magnetic Resonance Imaging is a radiation free non invasive technique using magnetic radiofrequency waves to image the body. In this study, the research team would like to investigate the possibility of providing functional information on aggressiveness, vascularity and oxygen uptake in liver cancer tumors.
16138323|NCT01871532|Drug|Gonal-f®|
16138324|NCT01871519|Device|Balloon kyphoplasty|The devices to be used in this study are intended for percutaneous balloon kyphoplasty (BKP) and consist of the Kyphon® bone access needles and cannulae, inflatable bone tamps, curettes, polymethyl methacrylate bone cement (PMMA) bone cements, and bone filler devices.
16138325|NCT01871506|Behavioral|Standard Care (SC)|"Initial counseling session: The initial counseling session will last approximately 45 minutes and will be conducted in-person or by phone by a tobacco treatment counselor. The session will be structured in a 5 As format and utilize Motivational Interviewing (MI) techniques.
~3 Weekly Follow-up Counseling Sessions: SC Patients will be offered 3 weekly proactive follow-up sessions, concentrated on quitting and staying quit throughout cancer treatment.
~Medication advice: The tobacco counselor will advise SC subjects to use smoking cessation medication to assist with their quit. Smoking cessation medication will not be provided by the study free of cost for SC subjects."
16138326|NCT01871506|Behavioral|Intensive Counseling (IC)|"The IC model includes all components of the SC as well as extended counseling support and up to 90 days of free FDA approved smoking cessation medication.
~Extended counseling support: Participants in the IC group will be offered the same initial 4 counseling sessions as the SC group as well as 4 additional proactive biweekly sessions and 3 monthly booster sessions.
~Smoking cessation medication: IC participants will be offered a 4-week supply of FDA-approved smoking cessation medication (varenicline, bupropion or nicotine replacement therapy) of their choice, with the option to renew the medication twice for up to 90 days of free medication. Participants are not required to take smoking cessation medication."
16138327|NCT01871493|Drug|LY2605541|Administered subcutaneous (SQ)
16138328|NCT01871493|Drug|Insulin Lispro|Administered SQ
16138329|NCT01871480|Drug|Group A:cytokine-induced killer cell +gefitinib|CIK cells: intravenous infusions; D14-16; one cycle every month,at least 6 cycles;Gefitinib treated with 250mg for daily oral administration in the absence of disease progression or unacceptable toxicity.
16138330|NCT01871480|Drug|Group B:Gefitinib|Gefitinib treated with 250mg for daily oral administration in the absence of disease progression or unacceptable toxicity
16138331|NCT01871467|Drug|Sargramostim|
16138332|NCT01871454|Radiation|stereotactic ablative radiotherapy (SABR)|standard of care radiation therapy
16138333|NCT01871454|Drug|Pentoxifylline|pentoxifylline
16138334|NCT01871441|Radiation|Total-body irradiation|Undergo TBI
16138335|NCT01871441|Biological|Donor lymphocytes infusion (DLI)|Undergo DLI
16138336|NCT01871441|Drug|Cyclophosphamide|Given IV
16138337|NCT01871441|Procedure|Allogeneic hematopoietic stem cell transplantation (HSCT)|Undergo haploidentical allogeneic HSCT
16138338|NCT01871441|Drug|Tacrolimus|Given IV
16138339|NCT01871441|Drug|Mycophenolate mofetil|Given IV
16138340|NCT01871428|Drug|aleglitazar|150 mcg orally daily
16138341|NCT01871428|Drug|placebo|matching aleglitazar placebo orally daily
16138342|NCT01871415|Drug|aleglitazar|150 mcg orally daily
16138343|NCT01871415|Drug|metformin|pre-existing background regimen and dose
16138344|NCT01871415|Drug|placebo|matching aleglitazar placebo orally daily
16138345|NCT01871402|Drug|000-0551 Lotion|
16138346|NCT01871402|Drug|Vehicle Lotion|
16138347|NCT01871376|Drug|Intravitreal aflibercept injection 2.0mg|Monthly 2.0mg intravitreal aflibercept injection, followed by Q8W dosing with 2.0mg intravitreal aflibercept injection or as often as monthly if needed for 1 year for both treatment naive and prior treatment arms.
16138385|NCT01870986|Biological|Humira (adalimumab-US)|40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.
16138386|NCT01870973|Procedure|root canal treatment, anesthesia, pain medications, and antibiotic|Root canal treatment is the intervention (no initial treatment versus initial treatment). We are not studying a drug or device.
16138348|NCT01871363|Radiation|chemoradiation|"radiotherapy: 50 Gy to the pelvis (25x 2 Gy on days 1-35, excluding weekends) .IMRT planing and technique with high energy photons will be used. All fields will be treated daily. Multileaf collimators will be used to shape individual radiation fields. Patients will be irradiated in a prone position with a full bladder and by using belly board to minimize exposure of the small bowel.
~capecitabine 825 mg/m² p.o. twice daily on days 1-35 (including weekends),
~bevacizumab: at dose 5 mg/kg on days -1, 15, 31.
~Radical surgery (TME): to be undertaken ideally 6-8 weeks following completion of chemoradiation."
16138349|NCT01871350|Dietary Supplement|Daily intake for 10 weeks (+/- 2 weeks)|
16138350|NCT01871337|Behavioral|Paula method|The Paula method will be taught to the participants by several registered Paula instructors. Subjects allocated to this intervention will receive one 45-minute group session per week for 12 weeks (with up to 30 minutes for personal questions regarding the exercises). This length of time is crucial because it has been demonstrated that it take three months for women to adequately learn the exercises in order for them to practice independently at home. Participants will be encouraged to practice daily for 15 minutes and report their at- home training.
16138351|NCT01871324|Behavioral|Lifestyle counseling|group therapy
16138352|NCT01871311|Drug|Nilotinib + Cetuximab|"Nilotinib BID for a 28-day cycle + Cetuximab 400 mg/m2 on day 1 dose then 250 mg/m2 weekly
~Three dose levels for nilotinib:
~Dose level -1 200-mg daily Dose level 1 200-mg BID Dose level 2 300-mg BID
~Cycle duration will be 4 weeks, with weekly evaluation of toxicity. Assessment of tumor progression will occur every 2 cycles. Subjects will be treated until disease progression or cessation due to intolerable toxicity."
16138353|NCT01871298|Other|Pilot Website Evaluation Component|The pilot health website will contain educational health information such as: health-related videos, searchable map of HIV prevention and other needed health and social services, and the option to register for automatic text message updates on relevant health information.
16138354|NCT01871285|Drug|Buprenorphine|
16138355|NCT01871285|Drug|Placebo film|Matching placebo buccal film
16138356|NCT01871285|Drug|Oxycodone|Oxycodone extended-release (ER) or immediate-release (IR) 5, 10, 15, 20, and 30 mg over-encapsulated oral tablets
16138357|NCT01871285|Drug|Morphine sulfate|Morphine sulfate 15, 30, and 60 mg ER or 15 and 30 mg IR over-encapsulated oral tablets
16138358|NCT01871285|Drug|Placebo capsule|Oral placebo capsules matching the over-encapsulated morphine sulfate and oxycodone tablets
16138359|NCT01871272|Procedure|Arthroscopic Meniscus Surgery|Surgery to the meniscus - resection or repair.
16138360|NCT01871233|Drug|Perampanel|Patients will enter this program on the same dose of perampanel that they were receiving at the end of their participation in Studies 207, 307, or 235. Doses of perampanel and of concomitant anti-epileptic drugs (AEDs) can be adjusted based on clinical judgment. A minimum daily dose permitted will be 12 mg per day. Treatment will be prescribed as long as clinically appropriate according to the judgment of the treating physician and the approved summary of Product Characteristics (SmPC). Tablets will be available in strengths of 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg. Patients will be instructed to take their perampanel tablets once daily, by mouth, before bedtime, and with food.
16138361|NCT01871220|Device|Concave Transition Profile|An Atlantis abutment is delivered with a concave transition profile.
16138362|NCT01871220|Device|Divergent Transition Profile|An Atlantis abutment is delivered with a linear transition profile
16138363|NCT01871181|Procedure|Ilioinguinal block|0.25% bupivacaine will be administered on a mg/kg basis
16138364|NCT01871181|Procedure|Local infiltration|Surgeon will infiltrate incision area with local anesthetic before closure.
16138365|NCT01871168|Procedure|TAP block|Infusion of 0.5-1% lidocaine
16138366|NCT01871168|Procedure|Sham TAP block|Infusion of saline
16138367|NCT01871155|Dietary Supplement|Nutri-jelly|"an edible nutritious gel for chewing and swallowing difficulties 1 box contains 250 ml with 250 kcal
~1 serving is considered as food supplement"
16138368|NCT01871142|Drug|Placebo|100 mL
16138369|NCT01871142|Drug|Aes-103|Single dose of 1000mg Aes-103 dissolved in 100 mL of Tropicana Pure Premium Orange Juice
16138370|NCT01871142|Drug|Aes-103|Single dose of 3000mg Aes-103 dissolved in 100 mL of Tropicana Pure Premium Orange Juice
16138371|NCT01871129|Drug|Dexmedetomidine|Dexmedetomidine will be diluted into a saline solution to a recommended concentration of 4 micrograms per millilitre. The saline will then be initially administered at the rate of 0.5 micrograms/kg/h and from that point the amount will be reduced to the point where the patient breathes well and is calm (compare dexmedetomidine recommendation at 0.2-1.4 ug/kg/h). The infusion rate will then be approximately 1-10 ml/h for a patient of 80 kgs weight. The exact dosage cannot be predetermined because it differs in each individual. In the control group the infusion speed is matching.
16138372|NCT01871129|Other|Saline (placebo)|Saline placebo infusion will be adjusted the same fashion as the active comparator drug.
16138373|NCT01871116|Behavioral|POWER-remote|Web-based weight loss program.
16138374|NCT01871116|Behavioral|Self-directed|"Pamphlet entitled Aim for a Healthy Weight will be given."
16138375|NCT01871103|Procedure|The dorsal homodigital island flap|The dorsal homodigital island flap is used for tissue reconstruction in different regions of the finger.
16138376|NCT01871090|Device|Unpaired remote monitoring transmitter|Unpaired remote monitoring transmitter
16138377|NCT01871077|Drug|PRO-156|Drug: PRO-156 ophthalmic solution One drop of PRO-156 ophthalmic solution administered to each eye, four times a day for 10 days.
16138378|NCT01871064|Device|TOF-Watch SX® Monitoring of NMB|Participants will have the extent of NMB monitored by a TOF-Watch SX®.
16138379|NCT01871025|Other|Hospital and home exercise training|Hospital exercise training (aerobic and strength) followed by exercise training
16138380|NCT01871025|Other|Usual care|Usual care includes respiratory physiotherapy techniques during hospitalization and adequate physical activity recommendations, but not exercise training
16138381|NCT01870999|Drug|aripiprazole IM depot|Aripiprazole IM depot supplied as 200 mg or 400 mg vials of lyophilized aripiprazole powder to prepare for IM injection.
16138382|NCT01870999|Drug|aripiprazole tablets|Aripiprazole tablets 10 mg once daily in the morning for 14 days.
16138383|NCT01870986|Biological|PF-06410293|40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.
16138384|NCT01870986|Biological|Humira (adalimumab-EU)|40 mg/0.8 mL administered by sub-cutaneous injection with a single-use prefilled syringe.
16138555|NCT01869738|Device|MGuard Prime|
16138388|NCT01870960|Other|7 patients will be recuting to received EMDOGAIM in left side|
16138389|NCT01870960|Other|7 patients will be recuting to received EMDOGAIM in right side|
16138390|NCT01870947|Behavioral|Exercise on stationary recumbent exercise cycle|
16138391|NCT01870947|Behavioral|Health Education|"Informational brochure (Better Health and You, Weight Control Information Network, June, 2004)"
16138392|NCT01870947|Behavioral|Questionnaires|
16138393|NCT01870947|Procedure|Neuroimaging|Imaging data will be acquired on a Siemens 3.0T Wide-Bore Verio MRI scanner.
16138394|NCT01870947|Procedure|Genetic and Biomarkers|Patients will be asked to fast for approximately 12 hours and will have approximately 2 Tbs. of blood drawn at baseline and the end of treatment (EOT).
16138395|NCT01870934|Device|Camera|No real intervention, but a comparison of different methods including the new medical device 3D camera.
16138396|NCT01870921|Drug|Ticagrelor|90mg/tablet, 1 tablet bid
16138397|NCT01870908|Drug|tacrolimus|
16138398|NCT01870908|Drug|biological agents|
16138399|NCT01870895|Drug|YM060|oral
16138400|NCT01870895|Drug|Placebo|oral
16138401|NCT01870882|Behavioral|Attentional retraining|
16138402|NCT01870882|Behavioral|Control condition|
16138403|NCT01870869|Device|Anatomically shaped, silicone-filled breast implants with low height/projection or extra-full projection|Surgical implant
16138404|NCT01870856|Device|Spectacles|Per participant's habitual prescription
16138405|NCT01870856|Device|Delefilcon A contact lenses|Silicone hydrogel single vision contact lenses
16138406|NCT01870856|Device|Etafilcon A contact lenses|Hydrogel single vision contact lenses
16138407|NCT01870843|Drug|Escitalopram|Escitalopram will be administered as oral tablets 10 mg per day and then the dose of escitalopram will be flexibly adjusted up to maximum of 20 mg per day for the next 7 weeks, based on the investigator's clinical judgment.
16138408|NCT01870830|Other|Altitude exposure|Stay at different altitudes: 490, 1650, 2590 m
16138409|NCT01870817|Dietary Supplement|Home jejunostomy feeding|
16138410|NCT01870804|Drug|Rosuvastatin|
16138411|NCT01870804|Drug|Atorvastatin|
16138412|NCT01870791|Drug|Omegaven|Weekly omegaven infusion in combination with EOX chemotherapy
16138413|NCT01870778|Drug|RLX030|1 mg/mL solution in 6 mL vials
16138414|NCT01870778|Drug|Placebo|Matching placebo solution to serelaxin
16138415|NCT01870765|Device|non-invasive ventilation|non-invasive ventilation via face mask
16138416|NCT01870765|Device|high-flow oxygen|high-flow oxygen via nasal cannula
16138417|NCT01870765|Procedure|fiberoptic bronchoscopy|fiberoptic bronchoscopy including broncho-alveolar lavage
16138418|NCT01870752|Procedure|Transplantation of previously cryopreserved ovarian tissu|
16138419|NCT01870739|Drug|sacubitril/valsartan (LCZ696)|200 mg tablets
16138420|NCT01870739|Drug|olmesartan|
16138421|NCT01870739|Other|placebo to sacubitril/valsartan (LCZ696)|placebo
16138422|NCT01870739|Other|placebo to olmesartan|placebo
16138423|NCT01870739|Drug|Amlodipine (Optional)|If required, open label amlodipine (2.5 mg, 5 mg, or 10 mg qd) was added to treatment regimen
16138424|NCT01870726|Drug|INC280|"Phase Ib: INC280 was given at the starting dose of 200mg capsules twice daily with escalation to higher strengths.
~Phase II: INC280 was given at the dose of 400mg (tablets) twice daily."
16138425|NCT01870726|Drug|Buparlisib|Buparlisib was given at the starting dose of 50mg once daily with escalation to higher strengths.
16138426|NCT01870700|Drug|lactobacillus reuteri|Lactobacillus reuteri (DSM 17938) was administered in the dose of 108 colony-forming units (CFU) in tablets of a commercially available preparation (Reuflor, Italchimici, Pomezia; BioGaia AB, Stockholm, Sweden), 30 minutes after feeding, twice per day for 4 weeks
16138427|NCT01870700|Drug|placebo|a supplementation with placebo was administered in tablets of a commercially available preparation 30 minutes after feeding, twice per day for 4 weeks
16138428|NCT01870687|Drug|20mg VAC BNO 1095 FCT|
16138429|NCT01870687|Drug|Placebo|
16138430|NCT01870674|Drug|YH12852|
16138431|NCT01870674|Drug|Prucalopride|
16138432|NCT01870674|Drug|Placebo|
16138433|NCT01870661|Device|Long axis IV placement with ultrasound|Peripheral IV placement with the ultrasound probe viewing the vessel in the long axis.
16138434|NCT01870661|Device|Short axis IV placement with ultrasound|Peripheral IV placement with the ultrasound probe viewing the vessel in the short axis.
16138435|NCT01870648|Drug|Ondansetron|Eligible children will receive one weight based (0.13 - 0.26 mg/kg) dose of an oral ondansetron disintegrating tablet. Subsequent therapy will be in accordance with World Health Organization guidelines as dictated by the child's hydration status.
16138436|NCT01870648|Drug|Placebo|Eligible children will receive one dose of an oral disintegrating Placebo (sugar pill) tablet. Subsequent therapy will be in accordance with World Health Organization guidelines as dictated by the child's hydration status.
16138437|NCT01870635|Drug|Ondansetron|Eligible children will receive one weight based (0.13 - 0.26 mg/kg) dose of an oral ondansetron disintegrating tablet. Subsequent therapy will be in accordance with World Health Organization guidelines as dictated by the child's hydration status.
16138438|NCT01870635|Drug|Placebo|Eligible children will receive one dose of an oral disintegrating Placebo (sugar pill) tablet. Subsequent therapy will be in accordance with World Health Organization guidelines as dictated by the child's hydration status.
16138439|NCT01870622|Procedure|Flow waves|Flow waves will be used to confirm correct tube placement in newborn infants.
16138440|NCT01870622|Procedure|ECO2|ECO2 will be used to confirm correct tube placement in newborn infants.
16138441|NCT01870609|Drug|defactinib (VS-6063)|
16138442|NCT01870609|Drug|Placebo|Sugar pill manufactured to mimic defactinib tablet
16138443|NCT01870596|Drug|Cytarabine|Given IV
16138444|NCT01870596|Drug|CHK1 Inhibitor SCH 900776|Given IV
16138445|NCT01870596|Other|Laboratory Biomarker Analysis|Correlative studies
16138446|NCT01870583|Drug|Iodine povidone|Iodine skin preparation solution prior to cesarean delivery
16138447|NCT01870583|Drug|Chlorhexidine|Chlorhexidine skin preparation solution prior to cesarean delivery
16138556|NCT01869738|Device|(BMS/DES)|
16138557|NCT01869725|Drug|gallium Ga 68-edotreotide|Given IV
16138448|NCT01870583|Drug|Combination iodine and chlorhexidine|Combination iodine povidone and chlorhexidine skin preparation solution prior to cesarean delivery
16138449|NCT01870570|Other|Reference Glucose|
16138450|NCT01870570|Other|Food Product A: Corn Flakes|
16138451|NCT01870570|Other|Food Product B: Ginger Bread|
16138452|NCT01870570|Other|Food Product C:Sandwiched Breakfast Biscuit|
16138453|NCT01870570|Other|Food Product D: Crackers Nature|
16138454|NCT01870570|Other|Food Product E: Breakfast Biscuit|
16138455|NCT01870570|Other|Food Product F: White Bread|
16138456|NCT01870544|Dietary Supplement|Lactobacillus Rhamnosus GG|LGG will be administered orally for 44 days
16138457|NCT01870544|Dietary Supplement|Placebo|placebo will be administered daily for 44 days
16138458|NCT01870518|Device|Bilateral GPi DBS|
16138459|NCT01870518|Device|Bilateral STN DBS|
16138460|NCT01870505|Drug|BYL719|
16138461|NCT01870505|Drug|Letrozole|
16138462|NCT01870505|Drug|Exemestane|
16138463|NCT01870492|Drug|Activase|Patients treated with Activase
16138464|NCT01870492|Device|Endovascular therapy|Patients treated with endovascular therapy, such as IA-tPA, mechanical thrombectomy, etc for acute ischemic stroke or transient ischemic attack.
16138465|NCT01870479|Other|Live music|
16138466|NCT01870479|Other|Taped music|
16138467|NCT01870466|Drug|Cilostazol|cilostazol bid for 7 days
16138468|NCT01870466|Drug|Simvastatin|simvastatin qd for 7 days
16138469|NCT01870466|Drug|Rosuvastatin|rosuvastatin qd for 7 days
16138470|NCT01870440|Drug|Ozurdex Intravitreal Injection (0.7 mg)|Intravitreal Injection
16138471|NCT01870427|Drug|Aflibercept (2.0 mg)|Intravitreal Aflibercept (2.0 mg)
16138472|NCT01870414|Other|cryotherapy by immersion|the dominant leg was immersed in cold water for 20 minutes [2, 17], temperature of 4º C [22, 24], water level at 20 cm
16138473|NCT01870401|Device|Lutonix DCB|
16138474|NCT01870401|Device|Uncoated PTA Catheter|
16138475|NCT01870388|Drug|Baricitinib|Administered orally
16138476|NCT01870362|Drug|Probiotic (Inersan)|
16138477|NCT01870362|Drug|Placebo|
16138478|NCT01870349|Procedure|Gingival Crevicular Fluid Sampling|Gingival crevicular fluids will be sampled from single implant restorations that have been in function for at least 6 months
16138479|NCT01870336|Device|Combined treatment of medial knee osteoarthritis|
16138480|NCT01870323|Behavioral|SMART Behavioral Group|Test the efficacy of using social media to deliver a physical activity intervention based on social cognitive principles to increase lifestyle physical activity in low-active adolescents (i.e., access to regularly posted physical activity content on a study-specific, restricted access Facebook Group, as well as receipt of weekly video-based behavioral modules).
16138481|NCT01870323|Behavioral|SMART Informational Group|Test the efficacy of using social media to deliver a physical activity intervention to increase lifestyle physical activity in low-active adolescents (i.e., access to regularly posted physical activity content on a study-specific, restricted access Facebook Group, but does not receive the weekly video-based behavioral modules).
16138482|NCT01870310|Procedure|Catheterised renal denervation|
16138483|NCT01870297|Drug|LY3025876|Administered SQ
16138484|NCT01870297|Drug|Placebo|Administered SQ
16138485|NCT01870297|Drug|Liraglutide|Administered SQ
16138486|NCT01870284|Drug|Ixekizumab|Administered SC
16138487|NCT01870284|Drug|Placebo|Administered SC
16138488|NCT01870284|Drug|Adalimumab|Administered SC
16138489|NCT01870271|Behavioral|Developmentally adapted cognitive processing therapy|
16138490|NCT01870258|Other|ANN prediction of myocardial infarction|
16138491|NCT01870245|Drug|ACHN-975|Intravenous multiple dose
16138492|NCT01870245|Drug|placebo|Intravenous multiple dose
16138493|NCT01870232|Procedure|US guided block|Greater palatine nerve or inferior alveolar nerve blocks will be performed under US guidance
16138494|NCT01870219|Drug|Sevoflurane|sevoflurane was initiated at %8 sevoflurane for anesthesia induction and maintained at 2% to %4 until the electrical stimulus was delivered
16138495|NCT01870219|Drug|Ketamine|ketamine was given to 1mg/kg ıv bolus
16138496|NCT01870206|Biological|Trivalent OPV Birmex|Newborns who receive OPV vaccine produced in Vero cells by Birmex one dose of vaccine immediately after random allocation (at birth). A second dose is given four weeks after the first application.
16138497|NCT01870206|Biological|Trivalent OPV Sanofi Pasteur|Newborns who receive OPV vaccine produced in Vero cells by Sanofi Pasteur one dose of vaccine immediately after random allocation (at birth). A second dose is given four weeks after the first application.
16138498|NCT01870193|Dietary Supplement|Glycine, cysteine (as n-acetylcysteine), alanine|"Young controls will receive cysteine plus glycine for 2 weeks
~The elderly subjects will be randomized in a double-blinded design to receive either cysteine plus glycine OR alanine for a period of 4 months"
16138499|NCT01870180|Device|EyeBag|fabric bag of beads which can be heated in a microwave
16138500|NCT01870180|Other|Placebo|
16138501|NCT01870167|Drug|co-amoxiclav|a single iv dose of co-amoxiclav (50/mg/Kg) at the time of PEG insertion.
16138502|NCT01870167|Dietary Supplement|Placebo|Placebo
16138503|NCT01870154|Behavioral|Training|The objective of the intervention is learning from the work experience of professionals attending the workshop to know and recognize the risk and process of the burnout syndrome and the characteristics specific to the health setting, as well as promoting prevention lines by transmitting strategies to manage and control the elements and consequences of the syndrome process (physical, psychological, and social).
16138504|NCT01870141|Behavioral|Cognitive-Behavioral Intervention|"1 weekly individual 45 min-session for 24 weeks. The program comprises the following cognitive-behavioral strategies:
~self-monitoring
~problem solving
~goal definition
~cognitive restructuring
~activation of personal and social resources"
16138505|NCT01870128|Drug|Combination Steroid|Methylprednisolone 1000 mg intravenous for 3 days Methotrexate 15 to 25 mg PO per week Hydroxychloroquine 200 mg twice daily Sulfasalazine 2000 to 3000 mg per day
16138506|NCT01870128|Drug|Methotrexate|Methotrexate 15 to 25 mg PO per week
16138507|NCT01870128|Drug|Combination|Methotrexate 15 to 25 mg PO per week Hydroxychloroquine 200 mg Twice daily Sulfasalazine 2000 to 3000 mg per day
16138508|NCT01870115|Dietary Supplement|Fiber Pill|This fiber pill has been manufactured to mimic the pill that contains the dietary supplements melatonin (M), strontium citrate (S), vitamin D3 (D) and vitamin K2 (K) in appearance but does not contain the supplements
16138509|NCT01870115|Dietary Supplement|Melatonin, Strontium citrate, Vitamins D3 and K2|Each pill has been manufactured to contain the dietary supplements 2.5mg melatonin (M), 225mg strontium citrate (S), 1000IU vitamin D3 (D) and 30mcg vitamin K2 (K)
16138510|NCT01870102|Drug|Pelubiprofen IR (Pelubiprofen 30mg) TID|
16138511|NCT01870102|Drug|Pelubiprofen SR (Pelubiprofen 45 mg) BID|
16138512|NCT01870089|Device|SmartCare/PS-NIV Drägerwerk Lübeck Germany|
16138513|NCT01870076|Behavioral|Healing Touch|
16138514|NCT01870076|Behavioral|Healing Touch, Sham|
16138515|NCT01870076|Behavioral|Control, Presence|
16138516|NCT01870050|Drug|Dapsone gel - verum|
16138517|NCT01870037|Drug|Placebo (PBS-20% sucrose)|
16138518|NCT01870037|Drug|hMaxi-K|Single treatment/2 escalating dose levels (16000 µg and 24000 µg by intramuscular injection)
16138519|NCT01870024|Drug|Clonazepam|clonazepam 0,015 mg/kg
16138520|NCT01870024|Drug|Fosphenytoin|fosphenytoin 20 mg/kg Equivalent Phenytoin (EP) by intravenous infusion over a period of 15 minutes
16138521|NCT01870024|Drug|Placebo|placebo 20 mg/kg by intravenous infusion over a period of 15 minutes
16138522|NCT01870024|Drug|Lorazepam|lorazepam 0,1mg/kg by intravenous injection over a period of 2 to 3 minutes)
16138523|NCT01870011|Drug|Desflurane balanced anesthesia|Desflurane balanced anesthesia induced with thiopental sodium, remifentanil and atracurium and maintained with remifentanil target controlled infusion and desflurane inhalation
16138524|NCT01870011|Drug|Propofol total intravenous anesthesia|Propofol total intravenous anesthesia induced with propofol, remifentanil and atracurium and maintained with remifentanil and propofol target controlled infusion
16138525|NCT01869985|Drug|HCP1104 / Mulex Tab. and Airtal Tab.|HCP1104 / Eperisone plus Aceclofenac
16138526|NCT01869959|Drug|LY2405319|Administered SC
16138527|NCT01869959|Drug|Placebo|Administered SC
16138528|NCT01869946|Drug|Ropivacaine|
16138529|NCT01869933|Drug|OC-10X|
16138530|NCT01869920|Behavioral|Intervention group|Education on breastfeeding
16138531|NCT01869920|Behavioral|Usual care|Usual care
16138532|NCT01869907|Drug|Minocycline|100 mg once daily by mouth during 14 days
16138533|NCT01869907|Drug|placebo|once daily by mouth during 14 days
16138534|NCT01869907|Drug|Amitriptyline|25mg once daily by mouth during 14 days
16138535|NCT01869894|Procedure|metallic biliary stent insertion (double bare - S&G Biotech.)|The patients who had malignant biliary obstruction will be enrolled our study. Enrolled patient will be randomized to three group (uncovered double bare metallic stent (S&G Biotech.) vs. uncovered single bare metallic stent (S&G Biotech.) vs. uncovered single bare metallic stent (Taewoong Medical.)). After metallic biliary stent insertion, enrolled patients will be followed at least one time per one month. Blood test (including total bilirubin, gamma-GT) will be done for follow-up study. During follow-up period, if biliary obstruction is suspected, imaging study (CT or MRCP) will be done. With such follow-up tools, we compare 6-month patency rate and median patency duration among three groups.
16138536|NCT01869894|Procedure|metallic biliary stent insertion (single bare - S&G Biotech.)|The patients who had malignant biliary obstruction will be enrolled our study. Enrolled patient will be randomized to three group (uncovered double bare metallic stent (S&G Biotech.) vs. uncovered single bare metallic stent (S&G Biotech.) vs. uncovered single bare metallic stent (Taewoong Medical.)). After metallic biliary stent insertion, enrolled patients will be followed at least one time per one month. Blood test (including total bilirubin, gamma-GT) will be done for follow-up study. During follow-up period, if biliary obstruction is suspected, imaging study (CT or MRCP) will be done. With such follow-up tools, we compare 6-month patency rate and median patency duration among three groups.
16138537|NCT01869894|Procedure|metallic biliary stent insertion (single bare - Taewoong Medical.)|The patients who had malignant biliary obstruction will be enrolled our study. Enrolled patient will be randomized to three group (uncovered double bare metallic stent (S&G Biotech.) vs. uncovered single bare metallic stent (S&G Biotech.) vs. uncovered single bare metallic stent (Taewoong Medical.)). After metallic biliary stent insertion, enrolled patients will be followed at least one time per one month. Blood test (including total bilirubin, gamma-GT) will be done for follow-up study. During follow-up period, if biliary obstruction is suspected, imaging study (CT or MRCP) will be done. With such follow-up tools, we compare 6-month patency rate and median patency duration among three groups.
16138538|NCT01869881|Drug|Anplag(Sarpogrelate)|Sarpogrelate 100mg 2 tablets, bid, 400mg/day
16138539|NCT01869881|Drug|Placebo|Placebo 100mg 2 tablets, bid, 400mg/day
16138540|NCT01869855|Procedure|Subdural Drainage|
16138541|NCT01869855|Procedure|Subperiosteal Drainage|
16138542|NCT01869842|Procedure|percutaneous coronary intervention|the traditional percutaneous coronary intervention by Resolute zotarolimus-eluting stent insertion
16138543|NCT01869842|Procedure|OCT-guided percutaneous coronary intervention|the percutaneous coronary intervention using optical coherence tomography by Resolute zotarolimus-eluting stent insertion
16138544|NCT01869842|Procedure|percutaneous coronary intervention|the traditional percutaneous coronary intervention by Resolute zotarolimus-eluting stent insertion
16138545|NCT01869842|Procedure|OCT-guided percutaneous coronary intervention|the percutaneous coronary intervention using optical coherence tomography by Resolute zotarolimus-eluting stent insertion
16138546|NCT01869829|Drug|Observational antifungal therapy|"Observational study of primary antifungal therapy utilized and outcomes, including:
~fluconazole, voriconazole, amphotericin B, caspofungin, and micafungin
~All agents are given as standard of care."
16138547|NCT01869803|Drug|gemtuzumab ozogamicin|Given IV
16138548|NCT01869803|Other|laboratory biomarker analysis|Correlative studies
16138549|NCT01869790|Other|Different fat types|Saturated, monounsaturated fats
16138550|NCT01869777|Procedure|bioelectric impedance analysis|Undergo bioelectric impedance analysis
16138551|NCT01869764|Drug|omega-3 fatty acid|Given PO
16138552|NCT01869764|Other|placebo|Given PO
16138553|NCT01869764|Other|laboratory biomarker analysis|Correlative studies
16138554|NCT01869751|Drug|Prucalopride|Treatment with prucalopride for slow-transit constipation
16138558|NCT01869725|Procedure|positron emission tomography/computed tomography|Undergo gallium Ga 68-edotreotide PET/CT scan
16138559|NCT01869725|Radiation|indium In 111 pentetreotide|Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
16138560|NCT01869725|Procedure|computed tomography|Undergo indium In 111 pentetreotide contrast-enhanced CT scan
16138561|NCT01869725|Procedure|contrast-enhanced magnetic resonance imaging|Undergo indium In 111 pentetreotide contrast-enhanced CT or MRI scan
16138562|NCT01869712|Other|Cupping therapy|
16138563|NCT01869712|Other|Acupuncture|
16138564|NCT01869699|Drug|Acetaminophen|acetaminophen 1 gram/100mLs intravenously administered over 15 minutes
16138565|NCT01869699|Drug|Placebo|Normal saline placebo Normal saline 100 mLs intravenous, administered over 15 minutes
16138566|NCT01869686|Biological|Denosumab|60 mg
16138567|NCT01869673|Device|Face Mask|Patients will be ventilated trough a face mask first and trough a oral mask thereafter
16138568|NCT01869673|Device|Oral Mask|Patients will be ventilated trough an oral mask first and trough a face mask thereafter
16138569|NCT01869660|Behavioral|Shared Decision Making|The focus of the SDM is to empower patients to discuss their attitudes and preferences toward treatments.
16138570|NCT01869647|Radiation|Ultra low dose CT scan|Ultra low dose CT scan
16138571|NCT01869647|Radiation|Regular CT or Low Dose CT scan|Regular CT or Low Dose CT scan
16138572|NCT01869647|Radiation|No imaging|No imaging
16138573|NCT01869634|Drug|darunavir with ritonavir and fixed-dose viread+emtricitabine daily|
16138574|NCT01869621|Drug|Metformin|6 days treatment with metformin to steady-state
16138575|NCT01869608|Procedure|oral glucose tolerance test 2 days post-partum|Screening for type 2 diabetes after gestational diabetes mellitus.
16138576|NCT01869582|Device|Fetoscope, Fetal heart rate|
16138577|NCT01869582|Device|Upright Resuscitator, Resuscitation|
16138578|NCT01869582|Device|Doppler, Fetal heart rate|
16138579|NCT01869582|Device|Standard Resuscitator, Resuscitation|
16138580|NCT01869569|Drug|Pregabalin|At the 4-week dose-titration phase, will receive one capsule of pregabalin (75 mg) twice daily from Day 1 to Day 7, and two capsules of pregabalin (150 mg) twice daily from Day 8 to Day 14. From Day 15 to Day 28, patients will perform dosage adjustments based on the pain relief and tolerability. At maintenance phase, patients will take the optimized dosage of pregabalin.
16138581|NCT01869569|Drug|Placebo|At the 4-week dose-titration phase, will receive one capsule of placebo twice daily from Day 1 to Day 7, and two capsules of placebo twice daily from Day 8 to Day 14. From Day 15 to Day 28, patients will perform dosage adjustments based on the pain relief and tolerability. At maintenance phase, patients will take the optimized dosage of placebo.
16138582|NCT01869556|Drug|Oxytocin|Oxytocin 5IU IV bolus, followed by an infusion of oxytocin 20IU/L, running at at rate of 40mIU/min for 8 hours
16138583|NCT01869556|Drug|Ergot|Ergot 0.25mg IV
16138584|NCT01869556|Drug|Carboprost|Carboprost 0.25mg IM
16138585|NCT01869543|Other|Stand Alone Air Cleaner|This is an environmental intervention using a stand alone air cleaner designed to reduce the air pollution levels in the home.
16138586|NCT01869543|Other|HVAC Modification|This is an environmental intervention that modifies the home HVAC system to include high efficiency air filtration designed to reduce the air pollution levels in the home.
16138587|NCT01869517|Other|intrastromal corneal ring segments (Keraring) implantation|
16138588|NCT01869517|Other|Intrastromal corneal continuous ring (Myoring) implantation|
16138589|NCT01869504|Device|Balloon-tipped intercostal drain|Ballooned intercostal drain for pleural effusion, inserted using local anaesthetic and ultrasound guidance.
16138590|NCT01869491|Drug|Compound Sodium Alginate Double Action Chewable Tablets|2 tablets four times daily
16138591|NCT01869491|Drug|Matching placebo tablets|2 tablets four times daily
16138592|NCT01869478|Drug|Intravenous Thrombolysis|
16138593|NCT01869478|Device|Endovascular Arterial Reperfusion|
16138594|NCT01869465|Other|Pre-treatment snack|The snack will consist of a 300 ml Safi mango juice and a doughnut. Ingredients of the Safi mango juice include vitamin C, fruit flavors from concentrate, sugar, water, citric acid, color E 110 and preservative E 221. The doughnuts will be made of wheat flour, baking powder, sugar and cooking oil. A local manufacturer (House of Eden (U) Limited) will be contracted to make, pre-pack and distribute the snack to the research team at the schools during Mass Drug Administration (MDA). All children in the schools randomized to the snack arm will receive the snack shortly before swallowing the drug. The snack will be distributed by the class teachers who will also distribute record the treatment and snack in separate registers.
16138595|NCT01869465|Behavioral|Education arm|In the education arm, children will receive specific messages for schistosomiasis transmission and control 1 month prior to Mass Drug Administration (MDA). A synopsis of the messages will include the following:What schistosomiasis is and its public health significance among school age children, Schistosomiasis transmission methods, signs and symptoms and its complications, Control methods including the importance of taking preventive treatment annually, Side effects of preventive treatment, why some people suffer serious side-effects and others do not and what to do in order to mitigate the side effects.From each school, the head teacher and the school teacher in-charge of health and sanitation will be trained in the above aspects of schistosomiasis transmission and control, in basic principles of health education and in communication skills through a 2 days training workshop.
16138596|NCT01869452|Behavioral|therapeutic education|knowledge of disease, risk factors, diet, medication, alert symptoms
16138597|NCT01869439|Device|"gold standard LxW manual ruler measurement technique"|"Currently, the gold standard LxW manual ruler measurement technique is used for measuring the area of an external wound. The LxW is measured by measuring the longest length (head to toe) times the widest width (perpendicular to the length)."
16138598|NCT01869439|Device|WMMS ImageReview software's LxW measurement technique|This software measurement technique is part of tthe WMMS and also measures the external wound LxW by the longest length (head to toe) times the widest width (perpendicular to the longest length).
16138599|NCT01869439|Device|WMMS ImageReview software's Visual External Wound Trace|This is a measurement technique of the ImageReview software that enables the user to trace the perimeter edge of the wound's visual image.
16138776|NCT01868113|Drug|Inhaled corticosteroid|Inhaled fluticasone 500mcg 12 hourly up to discharge or a maximum of 5 days
16138600|NCT01869439|Device|WMMS ImageReview software's External Wound Trace Overlay|This measurement technique is a feature of the WMMS, utilizing the visual external wound trace and overlaying it onto the thermal wound site. From the thermal overlay, variation data such as the differences in the thermal intensities (gradient), mean, and the mode of the thermal wound bed can be measured.
16138601|NCT01869426|Dietary Supplement|VSL#3 drops|
16138602|NCT01869426|Dietary Supplement|VSL#3 drops placebo|
16138603|NCT01869413|Drug|Tranexamic Acid|Tranexamic acid will be administered as an intravenous infusion of 10 mg/kg over 10 minutes (loading dose) prior to surgical incision, followed by 5 mg/kg/hour continuous maintenance infusion for the length of surgery (typically 4 to 8 hours).
16138604|NCT01869413|Drug|Placebo|As there is no standard of care concerning administration of anti-fibrinolytic agents in cystectomy procedures, controls will follow the same dosing and schedule as above (loading dose followed by maintenance infusion), but with 0.9% sodium chloride.
16138605|NCT01869387|Device|Non-invasive ventilation|
16138606|NCT01869374|Device|MagVenture MagPro MST|Brain stimulation by magnetic means versus electrical standard unilateral Electroconvulsive Therapy (RUL ECT). Treatment will be administered 3 times a week.
16138607|NCT01869374|Biological|RUL ECT|RUL ECT using the Somatics Thymatron device with Ultrabrief stimulus. Treatment will be administered 3 times a week.
16138608|NCT01869361|Drug|Indomethacin|Study drug
16138609|NCT01869361|Drug|Placebo|Control drug
16138610|NCT01869348|Behavioral|Monitor intervention|"Investigators will lend each participant 1 Jawbone Up activity monitor and 1 mini tablet device. Participants will receive weekly brief phone calls with counseling related to self-efficacy and self-regulation. The monitors will be programmed to provide idle alerts that vibrate when participants have reached a cut point for a bout of sedentary behavior (e.g., 30 minutes). Participants will monitor their progress using an app on the tablet that provides graphical feedback on physical activity and sedentary behavior."
16138611|NCT01869335|Device|radiography|
16138612|NCT01869335|Device|MRI (magnetic resonance imaging)|
16138613|NCT01869322|Device|Sling and Swathe|Sling and Swathe immobilization of humeral shaft fracture.
16138614|NCT01869322|Device|Coaptation Splint|Coaptation splint immobilization of humeral shaft fractures.
16138615|NCT01869309|Drug|Prasugrel|Patients will discontinue ticagrelor treatment and start 10 mg prasugrel daily while continuing 81 mg of aspirin daily.
16138616|NCT01869309|Drug|Ticagrelor|Patients will be given 180 mg of Ticagrelor followed by 90 mg twice a day while continuing 81 mg of aspirin daily).
16138617|NCT01869296|Procedure|higher flow rates|higher flow rates endoscope pump water immersion colonoscopy : 10.4 ml/sec
16138618|NCT01869296|Procedure|lower flow rates|lower flow rates endoscope pump water immersion colonoscopy : 1.7 ml/sec
16138619|NCT01869283|Other|Kinesiotherapy|
16138620|NCT01869283|Other|Ultrasound|
16138621|NCT01869283|Other|Diadynamic currents|
16138622|NCT01869257|Device|Triclosan coated suture|The patients in the treated arm will have the abdominal wound sutured with triclosan-coated suture
16138623|NCT01869257|Device|regular suture|The control arm will have the abdominal wound sutured with a regular non-coated suture
16138624|NCT01869231|Dietary Supplement|olive oil|
16138625|NCT01869231|Dietary Supplement|olive oil and chewing gum|
16138626|NCT01869231|Dietary Supplement|chewing gum|
16138627|NCT01869231|Dietary Supplement|water|
16138628|NCT01869205|Device|Endobronchial valve|One-way endobronchial valves are placed in segmental bronchi of the most hyperinflated and least perfused lobe of the emphysematous lungs on computed tomography (CT). Before the procedure, we confirm that the target lobe has no collateral ventilation with other lobes using Chartis® System (Pulmonx, Inc. Redwood City, CA, USA).
16138629|NCT01869192|Drug|Epirubicin|Epirubicin 90 mg/m2 d1 q3w
16138630|NCT01869192|Drug|Cyclophosphamide|Cyclophosphamide 600 mg/m2 d1 q3w
16138631|NCT01869192|Drug|Docetaxel|Docetaxel 75 mg/m2 d1 q3w
16138632|NCT01869192|Drug|Capecitabine|Capecitabine 1000 mg/m2/dose bid x 14d q3w
16138633|NCT01869192|Radiation|Radiation Therapy|Standard dosing, fields depending on clinical findings
16138634|NCT01869179|Behavioral|Community of Voices choir program|Attend weekly choir sessions for 12 months at the Senior Center. All choir sessions will include activities that focus on cognitive, psychosocial, and physical engagement components Choir sessions will last 90 minutes each with a 10 minute break. Take part in 3-4 informal choir concerts.
16138635|NCT01869179|Behavioral|Wait-list control group|
16138636|NCT01869166|Biological|CART-EGFR|
16138637|NCT01869140|Device|spinal manual therapy|spinal manipulation either manual or instrumental (activator)
16138638|NCT01869127|Device|Shoes|A unisex canvas slip-on with a sturdy sole.
16138639|NCT01869114|Drug|Sirolimus|Given PO
16138640|NCT01869114|Drug|Azacitidine|Given IV
16138641|NCT01869088|Drug|Recombinant Human Adenovirus Type 5 Injection|After identifying the target artery of HCC, Recombinant Human Adenovirus Type 5 Injection（15.0*1011vp：0.5ml*3） will be first infused through the target artery
16138642|NCT01869088|Procedure|Transartery Chemoembolization|Transartery chemoembolization with chemothrapy drugs (E-ADM 50mg, Lobaplatin 50 mg, MMC 6mg)and followed with embolization with lipiodol or/and polyvinyl alcohol particles.
16138643|NCT01869075|Other|Knowledge Translation (KT) toolkit|KT toolkit consists of: use of pre-printed orders, use of pharmacist as project lead and human reminder for prescribing, audit and feedback, education for staff
16138644|NCT01869062|Device|SonR CRT Optimization 'On'|Intervention: Implanted CRT-D device with the SonR optimization algorithm programmed being 'on'.
16138645|NCT01869062|Device|SonR CRT Optimization 'Off'|Intervention: Implanted CRT-D device with the SonR optimization algorithm programmed being 'off' (Standard of Care).
16138646|NCT01869036|Drug|caudal anesthesia|Standard caudal anesthesia (Marcaine 2mg/kg)
16138647|NCT01869036|Drug|caudal anesthesia supplemented with morphine|Caudal anesthesia supplemented with Morphine (10 µg/kg in children less than 10 kg and 20 µg/kg in children more than 10 kg)
16138648|NCT01869023|Drug|Gemcitabine|Combination of Gemcitabine 250 mg/m2 in six hour infusion with cisplatin 35 mg/m2 administered day 1 and 8, for six cycles.
16138649|NCT01869023|Drug|Cisplatin|Cisplatin 35 mg/m2SC applied on day 1 of 3 weeks cycles
16138650|NCT01869010|Other|Low sodium water overload in HIV tenofovir, HIV no tenofovir and seronegative controls|This test is based on the exploration of the tubular response to an acute fluid load. After overnight fast, all participants received twenty cc/Kg of mineralized water per os and two liters of intravenous hypotonic solution (0.66%) infused in two hours. Three blood samples are drawn (at 0, 60 and 120 minutes) and also urine samples are collected from each person at baseline and at 30 (±5) minutes intervals during the whole test. From the obtained blood and urine samples creatinine and osmolarity are measured, and then from the data corresponding to the most hypotonic urine sample (maximum dilution) and its corresponding blood sample three renal physiological parameters (proximal sodium clearance, free water clearance, sodium TALH reabsorption) are analyzed. Since patient inclusion follow up period is one month
16138651|NCT01868997|Drug|teprotumumab|
16138652|NCT01868997|Drug|normal saline|
16138653|NCT01868984|Drug|Paclitaxel|Paclitaxel solution treatment of each lesion encountered will be attempted until the 20 mg Paclitaxel dose limit is met. The volume administered will depend on the diameter and length of the venous outflow segment.
16138654|NCT01868984|Procedure|Standard Therapy|Standard treatment of all stenotic lesions will be carried out in the usual fashion. Intravenous heparin will be administered in a standard dose of 70 units/kg. Lesions that respond poorly to angioplasty (>30% residual stenosis after angioplasty treatment with 2 inflations) will be stented. Stent selection will be based on clinical setting. Initial stent treatment will utilize an uncovered nitinol stent. Treatment of in-stent restenosis will include initial balloon angioplasty, and use of a covered stent (Viabahn, GORE, or Fluency, Bard).
16138655|NCT01868971|Device|EndoRings|Colonoscopy procedure, standard endo-therapy interventions will be performed in accordance with physician's evaluation
16138656|NCT01868945|Dietary Supplement|5 µg/day Hy.D Calcifediol|5 µg/day Hy.D Calcifediol taken together with breakfast for a total period of 24 weeks
16138657|NCT01868945|Dietary Supplement|10 µg/day Hy.D Calcifediol|10 µg/day Hy.D Calcifediol taken together with breakfast for a total period of 24 weeks
16138658|NCT01868945|Dietary Supplement|15 µg/day Hy.D Calcifediol|15 µg/day Hy.D Calcifediol taken together with breakfast for a total period of 24 weeks
16138659|NCT01868945|Dietary Supplement|20 µg/day vitamin D3|20 µg/day vitamin D3 taken together with breakfast for a total period of 24 weeks
16138660|NCT01868932|Other|hypertonic saline|inhaled nebulized 3%NaCl
16138661|NCT01868932|Other|saline|inhaled nebulized 0.9% NaCl
16138662|NCT01868919|Behavioral|Positive Parenting Program|Level 3 or 4 of Triple P
16138663|NCT01868906|Drug|18F-FMISO|18F-FMISO-PET scanning, for tumor hypoxia assessment before radio-chemotherapy.
16138664|NCT01868906|Procedure|PET without SCS|PET-scanning using 18F-fluoromisonidazole without SCS
16138665|NCT01868906|Device|SCS|Electrical stimulation of spinal cord, minimally invasive neurosurgical technique used to treat refractory pain and ischemic syndromes.
16138666|NCT01868906|Procedure|PET without/with SCS|Second PET-scanning using 18F-fluoromisonidazole: without/with SCS
16138667|NCT01868906|Radiation|Radiotherapy|Standard radiation therapy
16138668|NCT01868906|Drug|Temozolomide|Standard treatment with concurrent and adjuvant Temozolomide.
16138669|NCT01868893|Drug|Obinutuzumab|
16138670|NCT01868893|Drug|Chlorambucil|
16138671|NCT01868880|Drug|Ivabradine plus beta-blocker (bisoprolol)|Ivabradine will be administered at a dose of 5 mg twice daily in addition to a low dose of beta-blocker (bisoprolol 1,25 or 2,5 mg). After four weeks of treatment ivabradine will be eventually lowered up to 2,5 mg twice daily in the presence of side effects (phosphenes, diplopia, headache or dizziness).
16138672|NCT01868880|Drug|betablocker titration|Beta blocker Bisoprolol will be up-titrated biweekly starting from the initial dose of 1,25-2,5 mg daily up to the max dose of 10 mg daily or to the maximum tolerated dose.
16138673|NCT01868867|Behavioral|Intervention|On line tutorial followed by text messaging during treatment and iPad for patient education
16138674|NCT01868841|Drug|AdreView|10 millicurie of AdreView (123I-mIBG)
16138675|NCT01868841|Other|Single Photon Emission Computed Tomography|
16138676|NCT01868828|Drug|PAD|Induction Therapy of PAD for 4 cycles.
16138677|NCT01868828|Drug|VCD|Induction Therapy of VCD for 4 cycles.
16138678|NCT01868828|Other|ASCT|Not suitable for transplant patients will continue accept treatment for 8 cycles.
16138679|NCT01868802|Drug|Ketamine|A single dose of 0.5mg/kg intravenous ketamine infusion will be administered over 40 minutes.
16138680|NCT01868802|Drug|Placebo|Saline at 0.9% intravenous infusion will be administered over 40 minutes.
16138681|NCT01868789|Radiation|Weightbearing CT|
16138682|NCT01868776|Drug|buffered lidocaine|
16138683|NCT01868776|Drug|nonbuffered lidocaine|
16138684|NCT01868763|Device|telemedical devices (weighing machine and step counter)|
16138685|NCT01868763|Behavioral|care calls once per week for 12 weeks|
16138686|NCT01868750|Dietary Supplement|Calcitriol|1.0ug twice daily for 7 days before surgery
16138687|NCT01868750|Dietary Supplement|Control Pill|placebo pill taken twice daily for 7 days before surgery
16138688|NCT01868737|Dietary Supplement|Probiotic|Lactobacillus rhamnosus GG and Bifidobacterium infantis'
16138689|NCT01868737|Dietary Supplement|Placebo|MCT oil
16138690|NCT01868711|Behavioral|Cognitive Behavior Therapy|
16138691|NCT01868698|Other|high-voltage electrical stimulation|
16138692|NCT01868698|Other|Kinesiotherapy|
16138693|NCT01868698|Other|shortwave diathermy|
16138694|NCT01868685|Drug|BYM338|BYM338
16138695|NCT01868685|Drug|Placebo|Placebo
16138696|NCT01868672|Behavioral|Educational print materials and coaching call|Intervention group participants receive three sets of mailed educational materials about making their home smoke-free and one coaching call.
16138697|NCT01868659|Behavioral|Diagnostic checklist|Diagnostic checklist used before patient discharged
16138698|NCT01868659|Behavioral|Usual care with no diagnostic checklist|Patient receives usual care with no research intervention
16138777|NCT01868113|Other|Placebo|Placebo to be administered 12hourly
16138778|NCT01868100|Other|self-completion questionnaire|
16138779|NCT01868087|Dietary Supplement|Boost Plus®|
16138780|NCT01868087|Dietary Supplement|Impact Advanced Recovery®|
16138781|NCT01868074|Device|Insole|Custom-molded arch-supporting insole
16138699|NCT01868646|Drug|Subetta|"Each Subetta tablet contains a mixture of affinity purified polyclonal antibodies to β-subunit of the rINS (6 mg) and antibodies to eNOS (6 mg) in released-active form produced by the patented technology in accordance with the applicable European Pharmacopeia requirements.
~Standard therapy of type II diabetes mellitus + Subetta (1 tablet 4 times a day) for 36 weeks.
~Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime)."
16138700|NCT01868646|Drug|Placebo|"Placebo (identical to Subetta in shape and taste tablet containing exсipients). Standard therapy of type II diabetes mellitus + Placebo (1 tablet 4 times a day) for 36 weeks.
~Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime)."
16138701|NCT01868633|Drug|Dexamethasone|
16138702|NCT01868633|Drug|Placebo|
16138703|NCT01868620|Device|Iontophoretic CXL|
16138704|NCT01868620|Device|Standard CXL|
16138705|NCT01868594|Drug|Subetta|"Each Subetta tablet contains a mixture of affinity purified polyclonal antibodies to β-subunit of the rINS (6 mg) and antibodies to eNOS (6 mg) in released-active form produced by the patented technology in accordance with the applicable European Pharmacopeia requirements.
~Standard therapy of type I diabetes mellitus + Subetta (1 tablet 4 times a day) for 36 weeks.
~Subetta: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime)."
16138706|NCT01868594|Drug|Placebo|"Placebo (identical to Subetta in shape and taste tablet containing exсipients). Standard therapy of type I diabetes mellitus + Placebo (1 tablet 4 times a day) for 36 weeks.
~Placebo: oral administration, per 1 intake - 1 tablet (keep in the mouth until complete dissolution, not at mealtime)."
16138707|NCT01868581|Drug|insulin degludec|Each subject will be allocated to 2 single injections of trial product on 2 separate dosing visits, administered subcutaneously (s.c., under the skin).
16138708|NCT01868581|Drug|insulin degludec/insulin aspart|Each subject will be allocated to 2 single injections of trial product on 2 separate dosing visits, administered subcutaneously (s.c., under the skin).
16138709|NCT01868568|Drug|insulin degludec|Administered subcutaneously (s.c., under the skin).
16138710|NCT01868568|Drug|insulin degludec/insulin aspart 30|A single dose administered subcutaneously (s.c., under the skin).
16138711|NCT01868568|Drug|insulin degludec/insulin aspart 40|A single dose administered subcutaneously (s.c., under the skin).
16138712|NCT01868568|Drug|insulin degludec/insulin aspart 45|A single dose administered subcutaneously (s.c., under the skin).
16138713|NCT01868568|Drug|insulin degludec/insulin aspart 55|A single dose administered subcutaneously (s.c., under the skin).
16138714|NCT01868568|Drug|insulin aspart|A single dose administered subcutaneously (s.c., under the skin).
16138715|NCT01868568|Drug|biphasic insulin aspart 30|A single dose administered subcutaneously (s.c., under the skin).
16138716|NCT01868568|Drug|placebo|A single dose administered subcutaneously (s.c., under the skin).
16138717|NCT01868555|Drug|insulin degludec|Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days
16138718|NCT01868555|Drug|insulin degludec/insulin aspart 30|Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days
16138719|NCT01868555|Drug|insulin degludec/insulin aspart 45|Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days
16138720|NCT01868555|Drug|placebo|Administered as once daily subcutaneous (s.c., under the skin) dose per 0.6 nmol/kg body weight for 6 days
16138721|NCT01868542|Drug|insulin detemir|Insulin detemir was administered once daily to the subjects. The dose was titrated based on the previous breakfast SMPG values.
16138722|NCT01868529|Drug|insulin degludec|Once daily dosing administered subcutaneously (s.c., under the skin) followed by a clamp visit. The two treatment periods will be separated by a wash-out period where the subjects will resume their normal insulin treatment.
16138723|NCT01868529|Drug|insulin glargine|Once daily dosing administered subcutaneously (s.c., under the skin) followed by a clamp visit. The two treatment periods will be separated by a wash-out period where the subjects will resume their normal insulin treatment.
16138724|NCT01868516|Drug|dexmecamylamine|
16138725|NCT01868516|Drug|Placebo|
16138726|NCT01868503|Drug|lapatinib ditosylate|Given PO
16138727|NCT01868503|Radiation|radiation therapy|Undergo radiation therapy
16138728|NCT01868503|Other|laboratory biomarker analysis|Correlative studies
16138729|NCT01868490|Drug|cytokine induced killer cells|at least 10*9 CIK cells, IV on day 0, 14, 28
16138730|NCT01868477|Drug|Deferasirox DFX, DT|provided as dispersible tablets for oral use in 125 and 250, 500 mg
16138731|NCT01868477|Drug|Erythropoietin alpha|
16138732|NCT01868477|Drug|Deferasirox DFX, FCT|provided as film-coated tablet for oral use in 90, 180, 360 mg strengths
16138733|NCT01868464|Biological|BCG TICE strain|All doses: Tice Bacillus Calmette-Guerin (BCG) will be administered as a single 0.1 ml ID injection over the deltoid muscle of the preferred arm. Groups 1 - 4 will receive one dose of Tice BCG intradermally at 2x10^6 cfu, 4x10^6 cfu, 8x10^6 cfu and 16x10^6 cfu, respectively.
16138734|NCT01868451|Drug|Brentuximab vedotin (SGN-35)|
16138735|NCT01868451|Drug|Doxorubicin HCL|
16138736|NCT01868451|Drug|Vinblastine Sulfate|
16138737|NCT01868451|Drug|Dacarbazine|
16138738|NCT01868451|Radiation|Involved-Site Radiation Therapy (ISRT)|
16138739|NCT01868451|Procedure|Interim PET|
16138740|NCT01868451|Radiation|consolidation volume RT (CVRT)|
16138741|NCT01868438|Drug|pyronaridine-artesunate granules|
16138742|NCT01868438|Drug|Pyronaridine-artesunate tablets|
16138743|NCT01868425|Drug|multimodal:acetaminophen, gabapentin, ketamine, bupivacaine|acetaminophen, gabapentin, ketamine, bupivacaine and standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane
16138744|NCT01868425|Drug|placebo pills and injectables|receives standard care which includes ketorolac, bupivacaine, fentanyl, ondansetron, dexamethasone, sevoflurane plus placebos of intervention arm meds
16138782|NCT01868061|Drug|Lebrikizumab|Lebrikizumab will be administered as SC injection at 125 or 37.5 mg every 4 weeks, for 104 weeks.
16138783|NCT01868061|Drug|Placebo|Lebrikizumab matching placebo will be administered as SC injection every 4 weeks for 52 weeks.
16138745|NCT01868412|Device|Abilar 10% resin salve|The resin salve may be spread directly onto the wound, after which the area is covered with a bandage suitable for local wound care. The bandage prohibits salve from moving away from the wound area. If the skin condition is more widespread or contains cavities or fistulae, the salve may be spread as a film with a thickness of at least 1 mm onto a gauze or gauze ribbon that is then used to fill the cavity or fistulae channel. Bandages are changed every 1-3 days, depending on the degree of infection and amount of wound secretion.
16138746|NCT01868412|Device|Activon Tube 25 g|Wound care with the medical honey is carried out in the same manner than the resin salve treatment: honey may be spread directly onto the wound and the wound area is covered with a bandage suitable for local wound care. Similarly, if the skin condition is more widespread or wound contains cavities or fistulae, the medical honey may be spread as a film with a thickness of at least 1 mm onto a gauze or gauze ribbon that is then used to fill the cavity or fistulae channel. Bandages are changed every 1-3 days, depending on the severity of infection and amount of wound secretion.
16138747|NCT01868386|Radiation|Hypofractionated therapy|Shorter courses of increasing doses of radiation therapy will be assessed in each subsequent arm
16138748|NCT01868373|Biological|Microbiota Transplantation (FMT)|Active therapy
16138749|NCT01868360|Drug|Subconjunctival aflibercept|subconjunctival aflibercept injection
16138750|NCT01868360|Other|Placebo: Standard of care only|Patients will receive standard of care (steroids and cyclosporine) treatment only.
16138751|NCT01868347|Other|treatment|preemptive PEEP before pneumoperitoneum and trendelenburg
16138752|NCT01868347|Other|control|PEEP after pneumoperitoneum and trendelenburg
16138753|NCT01868334|Behavioral|Pillar 1: Convenient Vaccination Services|"Extend Vaccination Season: Begin vaccinating for influenza as soon as vaccine arrives; use every visit as opportunity to vaccinate; extend the season for influenza by vaccinating in January and beyond.
~Use Express Vaccination services such as influenza vaccination clinics, Open access vaccine scheduling (for all vaccines), or dedicated vaccination station. When giving influenza vaccination, screen for need for PPSV/Tdap."
16138754|NCT01868334|Behavioral|Pillar 2: Patient notification|"Patient Education: notifying patients of doctor recommendations for vaccination; providing information on express vaccination services via email, autodialer, on-hold messages, clinic websites, and/or social media"
16138755|NCT01868334|Behavioral|Pillar 3: Enhanced Office Systems|Routine assessment for office systems flow to ensure staff consistently promoting vaccination: utilization of EMR prompts, review of Immunization tabs within EMR, and/or checking vaccination status as part of vital signs when rooming. Empower staff to vaccinate by use of a standing orders program (SOP). Order a sufficient supply of vaccination to cover increased rates
16138756|NCT01868334|Behavioral|Pillar 4: Motivation|Utilization of an Office Immunization Champion who will track overall progress towards their goal - setting a goal of increased rates of 20 to 25% for influenza vaccine; monitoring and sharing progress with staff regularly; and changing office systems flow as needed to increased vaccination rates.
16138757|NCT01868295|Behavioral|Sleeping with denture|Sleeping with denture at night
16138758|NCT01868282|Procedure|Hamstrings block|patients enrolled in the study will receive subsartorial saphenous nerve block in all the three groups. Patients in group 1 will receive perimuscular injections around the gracilis and semi-tendinosus muscles. The needle is redirected to the fascial plane between Sartorius and gracilis muscle after the sub-sartorial canal block where 7.5 ml of 0.5% ropivacaine is injected around the muscle. The needle is further advanced to the fascial planes between semimembranosus and semitendinosus and an additional 7.5 ml of 0.5% ropivacaine will be injected around the semitendinosus muscle. Following this a sham injection of 10mL of saline for the anterior division of obturator nerve will also be performed as in group 2 to ensure blinding.
16138759|NCT01868282|Procedure|Obturator block|Patients in group 2 will receive anterior division of obturator nerve block along with subsartorial canal block. After ensuring aseptic precautions, the saphenous nerve block is performed similar to that as in group 1. The anterior branch of obturator nerve will be visualised in the proximal thigh medial to femoral vessels between adductor longus and adductor brevis. A 22 gauge 90 mm PNS block needle will be inserted under ultrasound guidance to reach the anterior division of obturator nerve confirmed with neurostimulation followed by injection of 10 ml of 0.5% ropivacaine around the nerve. This group will receive sham injection of 15mL of saline around semitendinosus and semimembranosus as in group 1
16138760|NCT01868282|Procedure|Control group|The patients in group 3 will form the control group. After performance of the subsartorial saphenous nerve block, patients in group 3 will receive sham injections of saline for the obturator nerve block and the hamstrings block (perimuscular injections).
16138761|NCT01868269|Drug|Dexamethasone acetate|"First step:
~immunosuppressive treatment with dexamethasone"
16138762|NCT01868269|Drug|dexamethasone and cyclophosphamide|second step (in case of insufficient response): immunosuppressive treatment with dexamethasone and cyclophosphamide
16138763|NCT01868269|Drug|dexamethasone and rituximab|third step (in case of insufficient response): immunosuppressive treatment with dexamethasone and rituximab
16138764|NCT01868256|Other|early discharge (<72 h)|
16138765|NCT01868256|Other|Conventional discharge|
16138766|NCT01868243|Drug|Dabigatran|Group 1 - Dabigatran 110 mg (50 patients)
16138767|NCT01868243|Drug|Warfarin|Warfarin adjusted-dose
16138768|NCT01868230|Behavioral|Lifestyle Intervention|
16138769|NCT01868191|Drug|Benfotiamine|Treatment with 600 mg/day for the first 3 months followed by 300 mg/day for 9 months
16138770|NCT01868191|Drug|Placebo for benfotiamine|Treatment with placebo for benfotiamine 600 mg/day for the first 3 months followed by 300 mg/day for 9 months
16138771|NCT01868178|Device|BIS and Spectral Entropy|The aim of the study was investigated the effectiveness of Spectral Entropy and BIS in avoiding awareness
16138772|NCT01868139|Device|Liquid nitrogen spray cryotherapy with the truFreeze device|Low-pressure liquid nitrogen is sprayed through an upper endoscope on the diseased esophageal tissue to freeze and destroy it. The upper endoscope enables direct visualization of mucosal freeze during spray of the liquid nitrogen onto the mucosa and avoids the need for direct contact with the tissues. The target area is frozen and thawed for several consecutive cycles. The treated tissue becomes necrotic and sloughs, with new, healthy tissue regenerating in its place.
16138773|NCT01868126|Drug|DE-117 ophthalmic solution|
16138774|NCT01868126|Drug|latanoprost ophthalmic solution|
16138775|NCT01868126|Other|Placebo|
16138817|NCT01867827|Other|Physical Exercise|
16138784|NCT01868048|Drug|Sativex|"Contains delta -9 tetrahydrocannabinol (THC), 27 mg/mL:cannabidiol (CBD), 25 mg/mL, in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring.
~Subjects receive study medication delivered in 100 microlitre actuations by a pump action oromucosal spray. Maximum permitted dose is 10 actuations per day. Each actuation delivers THC 2.7 mg and CBD 2.5 mg."
16138785|NCT01868048|Drug|Placebo|Oromucosal spray, containing no active drug but ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavoring and colorants. Maximum permitted dose is 10 actuations per day.
16138786|NCT01868035|Drug|tositumomab and iodine I-131 tositumomab|"Subjects received the following treatments of TST/I-131 TST by intravenous (IV) infusion:
~Dosimetric Dose: 450 mg of TST infused over 1 hour immediately followed by 35 mg of TST labeled with 5 milliCuries (mCi) of I 131 infused over 30 minutes.
~Therapeutic Dose: 7 to 14 days after the dosimetric dose, 450 mg of TST infused over 60 minutes, immediately followed by 35 mg of TST labeled with the subject-specific mCi activity of I 131 needed to deliver a total body dose of 75 centiGrays (cGy), infused over 30 minutes for subjects with a platelet count of 150,000/mm3. Subjects with platelet counts of 100,000 to 149,999/mm3 received 65 cGy, and obese subjects were dosed based upon 137% of their calculated lean body mass."
16138787|NCT01868022|Drug|GSK3052230|A clear to opalescent, colorless to pale yellow solution for IV infusion once weekly (Day 1, Day 8, Day 15) in each 21-day cycle with unit dose strengths/dose level of 5, 10, 15, and 20 mg/kg supplied in a sterile 25 mL glass vial.
16138788|NCT01868022|Drug|paclitaxel|paclitaxel will be from commercial stock.
16138789|NCT01868022|Drug|carboplatin|carboplatin will be from commercial stock.
16138790|NCT01868022|Drug|docetaxel|docetaxel will be from commercial stock.
16138791|NCT01868022|Drug|pemetrexed|pemetrexed will be from commercial stock
16138792|NCT01868022|Drug|cisplatin|cisplatin will be from commercial stock
16138793|NCT01868009|Device|ELLIPTA|Novel dry powder inhaler (placebo) with 30 doses (2 strips with 30 blisters per strip)
16138794|NCT01868009|Device|DISKUS|Multidose dry powder inhaler (placebo) containing a foil strip worth 60 blisters (1 strip with 60 blisters per strip)
16138795|NCT01867996|Drug|Retosiban|Retosiban will be supplied as clear colorless solution for infusion (300 mg in 20 mL via). Subject will receive loading dose of 6 mg over 5 min infusion followed by 6 mg/hour infusion for 12 hrs on Day 1 and Day 18.
16138796|NCT01867996|Drug|EFZ 600 mg|EZF 600 mg will be supplied as a yellow, capsular-shaped, film-coated tablet. Subjects will receive EFZ 600mg OD in the evening from Day 3 till Day 18.
16138797|NCT01867983|Behavioral|Weight gain prevention and smoking cessation|"The two intervention groups will receive weight gain prevention either:
~Simultaneous: weight control treatment simultaneous with cessation treatment (5 proactive calls with a quit coach combined with weight coach/nutritionist followed by 5 'contact control calls'), or Sequential: weight control treatment added after cessation treatment (5 proactive calls with a quit coach followed by 5 weight coach/nutritionist calls). All three study arms will include a total of 10 phone counseling calls, interactive web, mailed support materials, access to nicotine replacement therapy (NRT) and unlimited participant initiated calls."
16138798|NCT01867983|Behavioral|Smoking cessation|The control group will receive cessation treatment calls (5 proactive calls with a quit coach followed by 5 contact control calls.
16138799|NCT01867970|Device|Tool|"The It's LiFe! tool consists of three different elements:
~the 3D accelerometer (Figure 7-8);
~the application (app) on a Samsung Smartphone (Figure 6);
~a web application and server called It's LiFe! online (powered by Sananet). The transmission of data from the accelerometer towards the app is via a Bluetooth connection. Every 15 minutes, or when the users press the refresh button, the Smartphone will connect to the accelerometer. The accelerometer should be within a 5 meter distance from the Smartphone. The transmission of data from the Smartphone towards the It's LiFe! server is via an internet connection. Therefore the Smartphone needs a SIM card with a data subscription."
16138800|NCT01867970|Behavioral|Self-management Support Program|Consultations 1)The PN will increase awareness of the PA pattern, she will inform the patient about the health risks related to a sedentary lifestyle. Assessment of the PA level is done by completing the SQUASH questionnaire. The patient gets a leaflet with information about being active. 2)A day goal will be set in minutes a day, based on the results of the measurements of the first two weeks. The pre-measurement in condition 1 is an objective measurement by the tool and they are visible for the PN on the monitor portal of the It's LiFe! Server. The PN will encourage the patient to focus on goals that fit to the patient's preferences and to set up a SMART plan to reach personal goal. 3)The PN will discuss the results and barriers and facilitators related to physical activities. 4)The PN will discuss the results, behavior change and habits, with the patient.
16138801|NCT01867957|Biological|Low-dose GC1109|50ug/dose
16138802|NCT01867957|Biological|High-dose GC1109|100ug/dose
16138803|NCT01867957|Biological|Low-dose Placebo|0.9% Saline 0.5 mL
16138804|NCT01867957|Biological|High-dose Placebo|0.9% Saline 1.0 mL
16138805|NCT01867944|Behavioral|Perineal Self-Acupressure|The core of the technique is to have subjects repeatedly press on and massage their perineum before defecation to fragment and soften the stool before it passes the lower rectum and anus.
16138806|NCT01867944|Behavioral|Educational Control|Education on conventional treatment options for chronic constipation.
16138807|NCT01867918|Procedure|Radiofrequency ablation, microwave, radiation therapy|Radiofrequency ablation Microwave ablation Radiation therapy
16138808|NCT01867918|Drug|Standard Chemotherapy|
16138809|NCT01867892|Drug|ICT of oxapliplatin, irinotecan, leucovorin, and fluorouracil and CCRT|oxapliplatin ,irinotecan ,5FU +leucovorin ,RT 5,040cGy in 28 fractions/5.5 wks and 5FU 450mg/m2 iv 30min weekly
16138810|NCT01867892|Drug|ICT of Gemcitabine,oxapliplatin, leucovorin, and fluorouracil + CCRT|Gem ,Oxa ,5FU +LV ,RT 5,040cGy in 28 fractions/5.5 wks and Gem 400mg/m2 iv 40min weekly
16138811|NCT01867879|Drug|TAS-102|35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.
16138812|NCT01867879|Drug|Placebo|Placebo tablets, orally, single dose.
16138813|NCT01867866|Drug|TAS-102|35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria is met.
16138814|NCT01867866|Drug|Trifluridine|35 mg/m2, orally, single dose
16138815|NCT01867853|Device|PLR|passive leg raising test was done before and at the end of SBT
16138816|NCT01867827|Other|Neurofeedback and Physical Exercise|
16138818|NCT01867814|Procedure|Pneumoperitoneum|Pneumoperitoneum 15 mmHg and 10 mmHg
16138819|NCT01867775|Drug|Mirtazapine|Mirtazapine 15 mg, at night, once a day for 14 days
16138820|NCT01867762|Drug|JNJ 49095397|JNJ 49095397 400 microgram will be inhaled by participants once daily by using a dry powder inhaler for 12 weeks.
16138821|NCT01867762|Drug|Placebo|Placebo will be inhaled by participants once daily by using a dry powder inhaler for 12 weeks.
16138822|NCT01867749|Behavioral|Group Interpersonal Psychotherapy (IPT-G)|
16138823|NCT01867749|Behavioral|Coping with Depression (CWD)|
16138824|NCT01867736|Device|Passeo-18 Lux DRB|
16138825|NCT01867736|Device|Standard PTA (POBA)|
16138826|NCT01867723|Other|Internet communication application|Intervention 1 Effect of internet support program will be tested on cancer patients and their family caregivers No intervention
16138827|NCT01867710|Drug|Abiraterone Acetate|Type = exact number; unit = mg; number = 1000; form = tablet; route = oral; taken as four 250 mg tablets once daily at least 2 hours after eating and no food should be eaten for at least 1 hour after taking the tablets.
16138828|NCT01867710|Drug|Prednisone 5 mg twice daily|type = exact number; unit = mg; number = 5; form = tablet; route = oral; taken twice daily, the first dose in the morning after a meal and the second dose after a minimum interval of 8 hours in the late afternoon or early evening, after a meal
16138829|NCT01867710|Drug|Prednisone 5 mg once daily|type = exact number; unit = mg; number = 5; form = tablet; route = oral; taken once daily, in the morning after a meal
16138830|NCT01867710|Drug|Prednisone 2.5 mg twice daily|type = exact number; unit = mg; number = 2.5; form = tablet; route = oral; taken twice daily, the first dose in the morning after a meal and the second dose after a minimum interval of 8 hours in the late afternoon or early evening, after a meal
16138831|NCT01867710|Drug|Dexamethasone 0.5 mg once daily|type = exact number; unit = mg; number = 0.5; form = tablet; route = oral; taken once daily, in the morning after breakfast
16138832|NCT01867697|Drug|Cetuximab|
16138833|NCT01867697|Drug|Irinotecan|
16138834|NCT01867697|Drug|Oxaliplatin|
16138835|NCT01867697|Drug|Folinic Acid|
16138836|NCT01867697|Drug|Calcium Carbonate|
16138837|NCT01867684|Other|Psychotherapy|
16138838|NCT01867671|Biological|Peanut Oral Immunotherapy - Liquid Extract|Used during initial dose escalation for doses 0.1 to 0.8 mg.
16138839|NCT01867671|Biological|Placebo for Peanut Oral Immunotherapy - Liquid Extract form|Similar in appearance, texture, and taste to peanut liquid extract.
16138840|NCT01867671|Biological|Peanut Oral Immunotherapy - Peanut Flour|This will be used for the remainder of dose escalation, build-up, and maintenance.
16138841|NCT01867671|Biological|Placebo for Peanut Oral Immunotherapy - Peanut Flour|Similar in appearance, texture, and taste to peanut flour.
16138842|NCT01867658|Device|Progel® Pleural Air Leak Sealant|Video-assisted or robotic-assisted surgical lung procedures plus Progel® Pleural Air Leak Sealant
16138843|NCT01867645|Drug|IgM-enriched Intravenous Immunoglobulins|IgM-enriched IVIG (Pentaglobin, Biotest Pharma GmbH, Dreieich, Germany) at a dose of 0.25g/kg body weight/day as a continuous intravenous infusion at a rate of 2g/h over a period of 3 days.
16138844|NCT01867645|Drug|Human Albumin|Human albumin 1% (Biotest Pharma GmbH, Dreieich, Germany) as placebo at a dose of 0.25g/kg body weight/day as a continuous intravenous infusion at a rate of 2g/h over a period of 3 days
16138845|NCT01867632|Device|Acellular Dermal Matrix|
16138846|NCT01867606|Biological|serum-derived bovine immunoglobulin protein isolate|Given PO
16138847|NCT01867606|Other|placebo|Given PO
16138848|NCT01867606|Other|laboratory biomarker analysis|Correlative studies
16138849|NCT01867606|Other|quality-of-life assessment|Ancillary studies
16138850|NCT01867606|Other|questionnaire administration|Ancillary studies
16138851|NCT01867593|Device|C-11 methionine PET|
16138852|NCT01867580|Device|V.A.C.Ulta with Prontosan instillation|NPWT with instillation of a wound cleanser (Prontosan® Wound Irrigation Solution)
16138853|NCT01867580|Device|V.A.C.Ulta without instillation|NPWT only
16138854|NCT01867567|Procedure|abdominal bandage|
16138855|NCT01867554|Genetic|gene analysis|gene analysis
16138856|NCT01867528|Procedure|Laparoscopic adhesiolysis|
16138857|NCT01867528|Procedure|Open adhesiolysis|
16138858|NCT01867515|Other|Acoustic distortion of speech|
16138859|NCT01867502|Drug|MET + Vildagliptin Group|"Vidagliptin group will receive 50mg of this drug twice a day during 12 weeks added to usual metformin.
~For the glicemic control evaluation will be used the capilar glycemia at home. The adjustments will be done by the researcher coordinator."
16138860|NCT01867502|Drug|MET + Glibenclamide Group|"The initial dose of glibenclamide group will be 5mg / day during the first week of study, later it will increase to 10 mg / day (2 x 5mg). With the control the dose may be adjusted, reaching the maximum dose allowed, which is 20 mg / day.
~For the glycemic control evaluation will be used the capillar glycemia at home. The adjustments will be done by the researcher coordinator."
16138861|NCT01867489|Other|No intervention|
16138862|NCT01867476|Other|Automated Adherence Monitoring System|
16138863|NCT01867463|Biological|Pfs25-EPA/Alhydrogel|The Pfs25-EPA conjugate was produced by reaction between thiolated PpPfs25 and maleimideactivated EcEPA, followed by purification using size-exclusion chromatography. The cGMP Pfs25-EPA conjugate Lot# WRAIR1634 was manufactured at Walter Reed Bioproduction facility in cGMP compliance in May 2010. Alhydrogel (Brenntag, Denmark) is an aluminum hydroxide gel and has been extensively used as an adjuvant in licensed human vaccines. Alhydrogel is supplied as a sterile product in water without preservatives. Pfs25- EPA/Alhydrogel WRAIR Lot #1668 was manufactured and filled as single-use vials at Walter Reed Bioproduction facility in cGMP compliance in October 2010. Each vial contains 78 g/mL conjugated Pfs25, 93 g/mL conjugated EPA and 1600 g/mL Alhydrogel in a volume of 0.8 mL. The vial label reads: 78 g/mL Conjugated Pfs25 on Alhydrogel .
16138864|NCT01867463|Biological|Euvax B|Euvax B consists of highly purified, noninfectious particles of HBsAg absorbed onto aluminum salts as an adjuvant and preserved with thimerosal.
16138950|NCT01866722|Behavioral|Reduction|Participants will have 3 telephone counseling sessions that focus on ways to reduce tobacco cigarette smoking. After the final session printed materials with resources to help quitting will be mailed to the participants.
16139620|NCT01861587|Device|tDCS|20 minutes of either real or sham stimulation
16138865|NCT01867463|Biological|Menactra|Menactra , Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine, is a sterile, intramuscularly administered vaccine that contains Neisseria meningitidis serogroup A, C, Y and W-135 capsular polysaccharide antigens individually conjugated to diphtheria toxoid protein. N meningitidis A, C, Y and W-135 strains are cultured on Mueller Hinton agar (3) and grown in Watson Scherp (4) media. The polysaccharides are extracted from the N meningitidis cells and purified by centrifugation, detergent precipitation, alcohol precipitation, solvent extraction and diafiltration.
16138866|NCT01867437|Drug|Placebo|Sterile solution (vehicle) for subcutaneous infusion
16138867|NCT01867437|Drug|RM-493|Sterile solution (2mg/ml) for subcutaneous infusion
16138868|NCT01867424|Drug|Eovist|0.1 ml/kg Eovist will be administered intravenous (IV) to each patient
16138869|NCT01867333|Biological|PROSTVAC-F/TRICOM|A recombinant fowlpox virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.
16138870|NCT01867333|Biological|PROSTVAC-V/TRICOM|A recombinant vaccinia virus vector vaccine containing the genes for human PSA and three co-stimulatory molecules.
16138871|NCT01867333|Biological|Enzalutamide (Xtandi)|An androgen receptor inhibitor.
16138872|NCT01867320|Drug|Raltegravir|Raltegravir at 400mg by mouth twice daily in an initial 6 months treatment phase, followed by an additional 9 months post treatment phase.
16138873|NCT01867307|Drug|Empagliflozin|
16138874|NCT01867307|Drug|BI 10773|open label
16138875|NCT01867294|Drug|Doxycycline|Given PO
16138876|NCT01867294|Procedure|Management of Therapy Complications|Moisturizer given topically
16138877|NCT01867294|Other|Placebo|Given topically
16138878|NCT01867294|Other|Questionnaire Administration|Ancillary studies
16138879|NCT01867294|Drug|Spironolactone|Given topically
16138880|NCT01867294|Drug|Sunscreen|Given topically
16138881|NCT01867294|Drug|Therapeutic Hydrocortisone|Given topically
16138882|NCT01867281|Drug|aspirin|
16138883|NCT01867268|Drug|Acetazolamide|Acetazolamide administration for 10 days adjust dosage with weight of the patient
16138884|NCT01867268|Other|prone positioning|prone positioning the patient for 10 days following the surgery
16138885|NCT01867268|Other|Acetazolamide+ prone positioning|administration of acetazolamide and position the patient for 10 days following the surgery
16138886|NCT01867255|Drug|venlafaxine ER (extended-release) 75 mg|A single dose of venlafaxine ER 75 mg is to be administered once at each of two study visits, pre- and post-gastric bypass surgery.
16138887|NCT01867242|Other|Cigarettes|Smoke their usual brand of cigarettes and follow their normal patterns of use.
16138888|NCT01867242|Other|Snus|Winterchill or Robust flavors
16138889|NCT01867229|Other|observational|standard of care fore patients with non metastatic breast cancer
16138890|NCT01867216|Drug|Placebo|Administered orally as capsules
16138891|NCT01867216|Drug|LY2922470|Administered orally as capsules
16138892|NCT01867203|Other|Genotyping|DNA extraction from blood
16138893|NCT01867190|Biological|ASCT01 (Autologous Stem Cell Transplantation)|Single Administration of the entire ASCT01 preparation at rate if 10million CD45+ cells per milliliter at 5 ml per minute via the intra- via intra-arterial infusion route and 6 or more injections of approximately 0.2 ml each intramuscular route
16138894|NCT01867177|Other|HIV testing|"HIV testing. Enhanced testing protocol is used: RESPECT, an evidence-based HIV prevention counseling intervention helping people increase condom use, decrease risky behaviors (resulting in a decrease in STIs) compared to those who did not receive the intervention. RESPECT includes: one-on-one counseling using a structured protocol; teachable moments during counseling to motivate clients to change risk-taking behaviors; to explore the contexts in which risk behaviors occur to increase awareness of susceptibility; and negotiate achievable next steps with the client that support the larger risk reduction goal. Implemented using a structured protocol with monitoring to ensure the fidelity of the testing intervention."
16138895|NCT01867177|Other|standard of HIV care|Standard linkage and referral to HIV care includes HIV counseling, testing, and referrals. Both intervention and comparison groups will receive these.
16138896|NCT01867177|Behavioral|HIV care utilization|Sites will use a peer-based, client navigation model of an Integrated HIV/AIDS Early Intervention Services (ARTAS), Community Health Worker (CHW) Program, case management/support services linking people to continuous, coordinated care after HIV dx. Another site will do Motivational Enhancement Intervention (MEI) sessions with quality of ife workshops and support groups. Health Educators recruit clients, make appointments, escort to test sites, intake, review. Additional components can include food security support, social and group support, drop in centers, text messaging and social media, depending on sites. All sites focus on approaches to reach community members and facilitate their supportive linkage to care with behavioral and structural supports.
16138897|NCT01867164|Drug|Gynoclin V|One ovule containing 80 milligram (mg) terconazole, 100 mg clindamycin and 0.5 mg fluocinolone acetonide will be administered vaginally, every 24 hours at night, for 3 days.
16138898|NCT01867164|Drug|Vagitrol V|One ovule containing 500 mg metronidazole, 0.5 mg fluocinolone acetonide and 100,000.00 microgram/milliliter nystatin will be administered vaginally, every 24 hours at night, for 10 days.
16138899|NCT01867151|Dietary Supplement|Gluten Free Diet|
16138900|NCT01867151|Dietary Supplement|Normal Diet|
16138901|NCT01867138|Drug|Cefazolin|
16138902|NCT01867138|Drug|Vancomycin|
16138903|NCT01867138|Drug|Amikacin|
16138904|NCT01867125|Drug|Lebrikizumab|Lebrikizumab will be administered as SC injection at 125 or 37.5 mg every 4 weeks, for 104 weeks.
16138905|NCT01867125|Drug|Placebo|Lebrikizumab matching placebo will be administered as SC injection every 4 weeks for 52 weeks.
16138906|NCT01867112|Behavioral|Physical Activity|Physical activity either by individualized program or general guidelines
16138907|NCT01867086|Biological|Vigil™ Vaccine|Patients meeting eligibility criteria will receive Vigil™ 1.0 x 10e7 cells/intradermal injection once every 3 weeks.
16138951|NCT01866722|Behavioral|5Rs|Participants will have 3 telephone counseling sessions that focus on the 5Rs for quitting tobacco cigarette smoking (Relevance, Risks, Rewards, Roadblocks, Repeat). After the final session printed materials with resources to help quitting will be mailed to the participants.
16139000|NCT01866358|Procedure|Intraosseous infusion|Using intraosseous infusion for resustation in this group
16138908|NCT01867086|Drug|Carboplatinum|Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion) one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks. At recurrence, patients allergic to carboplatinum will receive docetaxel 75 mg/m2/1 hour infusion, one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection every 3 weeks. Patients with stable disease (SD) or better and unable to tolerate continued chemotherapy will be allowed to continue Vigil™ alone for up to 12 cycles or as long as vaccine is available; conversely, patients with SD or better who exhaust Vigil™ supply may continue on chemotherapy alone.
16138909|NCT01867086|Drug|Carboplatinum and Taxol|Patients meeting eligibility criteria will receive either carboplatinum alone (AUC 6/30 minute infusion) or carboplatinum (AUC 5/30 minute infusion) and taxol (175 mg/m2 3-hour infusion one day prior to Vigil™ 1.0 x 10e7 cells/ intradermal injection, once every three weeks. At recurrence, patients allergic to carboplatinum will receive docetaxel 75 mg/m2/1 hour infusion, one day prior to Vigil™ 1.0 x 10e7 cells/intradermal injection every 3 weeks. Patients with stable disease (SD) or better and unable to tolerate continued chemotherapy will be allowed to continue Vigil™ alone for up to 12 cycles or as long as vaccine is available; conversely, patients with SD or better who exhaust Vigil™ supply may continue on chemotherapy alone.
16138910|NCT01867073|Other|Biomarker|
16138911|NCT01867060|Device|Automated Cardiac Event Recorder|Automated Cardiac Event Recorder to be worn continuously for one week.
16138912|NCT01867060|Device|Personal Heart Rhythm Monitor|Personal Heart Rhythm Monitor to be used twice-daily for three months.
16138913|NCT01867047|Drug|ACE-I Cessation group|"Subjects stop ACE-I 48 hours prior to surgery. Examples of possible ACE-I drugs include:
~benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec, Epaned), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), trandolapril (Mavik)"
16138914|NCT01867047|Drug|ACE-I Continuation group|"Subjects take ACE-I through day of surgery. Examples of possible ACE-I drugs include:
~benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec, Epaned), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), trandolapril (Mavik)"
16138915|NCT01867034|Other|Drug Eluting Stent|Comparison of two stents to see which results in best outcome.
16138916|NCT01867034|Other|Bare Metal Stent|
16138917|NCT01867021|Biological|Fluvirin(TIVf)|
16138918|NCT01867021|Biological|Agriflu (TIV)|
16138919|NCT01867008|Device|Nucleus CI422 Cochlear Implant with N6 Sound Processor|
16138920|NCT01866995|Drug|"Raylis"|"Raylis (1 kapsule contains: ginseng root powder 50 mg, false ginseng root powder 50 mg, codonopsis root powder 50 mg, astragalus membranaceus root powder 50 mg, epimedium alpinum herbal extract 100 mg)"
16138921|NCT01866995|Other|standard prostatostasis therapy|
16138922|NCT01866982|Procedure|Umbilical Cord Milking|Umbilical cord milked toward the neonate four times at a speed of 20cm/2seconds, prior to clamping and cutting umbilical cord. Procedure takes about 10-20 seconds.
16138923|NCT01866982|Procedure|Delayed Cord Clamping|Performed by positioning the baby 20 cm below the placenta for 45-60 seconds prior to umbilical cord clamping and cutting.
16138924|NCT01866969|Other|questionnaire administration|Ancillary studies
16138925|NCT01866969|Procedure|quality-of-life assessment|Ancillary studies
16138926|NCT01866943|Drug|Tranexamic Acid|Tranexamic Acid 1.5 g (100 mg/mL)in 100cc normal saline is applied topically to the wound for 5 minutes time then suctioned and the skin closed. The control group receives just normal saline and no drug.
16138927|NCT01866943|Drug|Normal Saline Solution|
16138928|NCT01866930|Biological|Pegylated Interferon Lambda-1a|
16138929|NCT01866930|Drug|Daclatasvir (DCV)|
16138930|NCT01866930|Drug|Ribasphere (RBV)|
16138931|NCT01866917|Drug|Ropivacaine 0.5% 20cc injectate bilaterally|
16138932|NCT01866917|Drug|Placebo|
16138933|NCT01866891|Other|Three months of regular perdialytic physical activity (cycling)|Cycling, in lying position, at a rate of thirty minutes per dialysis session (three a week), regardless of performance
16138934|NCT01866878|Device|equipment rehabilitation stereognosis|
16138935|NCT01866878|Device|TENS|
16138936|NCT01866839|Device|Graft Manipulation (CD34+ Selection)|
16138937|NCT01866826|Drug|Rifaximin|subject will receive three capsules of rifaximin (183.3 mg each) by mouth twice daily (total 1100 mg Daily)
16138938|NCT01866826|Other|Placebo|subject will receive three capsules of placebo by mouth twice daily.
16138939|NCT01866813|Behavioral|Cognitive training intervention group|The intervention group will be asked to participate in an internet-delivered cognitive training pro-gram using the Danish edition of Scientific Brain Training Pro on their home personal computer. The software is provided through the Internet, and no software installation is needed onto the participant personal computer. Reminders to train will be provided by e-mail. The training involves working with the program for 40-60 minutes a day, five days a week, for six weeks.
16138940|NCT01866800|Device|Renal Guard|Renal Guard
16138941|NCT01866800|Drug|Conventional Treatment|Saline and N-acetylcysteine
16138942|NCT01866774|Other|Fecal calprotectin level|
16138943|NCT01866761|Procedure|Periodontal treatment|
16138944|NCT01866748|Drug|semaglutide|A maximum of six single-dose cohorts of oral semaglutide administered according to an ascending dose design. Starting dose 2 mg, max. dose 60 mg. Progression to next dose will be based on safety evaluation. Sequential cohorts.
16138945|NCT01866748|Drug|semaglutide|Oral semaglutide administered as five multiple dose cohorts, where one of the cohorts will test a different dosing condition compared to the others. End doses from 10 mg/day to 60 mg/day. Progression to next dose will be based on safety evaluation. Semi-parallel cohorts.
16138946|NCT01866748|Drug|placebo|In each cohort of 10, eight subjects will randomised to active treatment and two to placebo.
16138947|NCT01866748|Drug|placebo|In each cohort of 24, 16 subjects will be randomised to active treatment, four to placebo and four to a enhancer-containing placebo (placebo C).
16138948|NCT01866735|Other|Standardized Rehabilitation Therapy|
16138949|NCT01866722|Behavioral|Usual care|Participants will get a brief (<5 min) telephone counseling session about quitting. After that, printed materials with resources to help quitting will be mailed to the participants.
16138952|NCT01866709|Drug|Sodium polystyrene sulfonate|Oral suspension in water of 15g sodium polystyrene sulfonate administered three times (tid) daily for 48 hours without co-administration of Sorbitol.
16138953|NCT01866709|Drug|Silicified microcrystalline cellulose|Oral suspension in water of placebo administered three times (tid) daily for 48 hours.
16138954|NCT01866696|Device|oral implants|"For all cases, the following surgical and prosthetic protocol was followed.:
~Clinical examination
~Radiological examination
~Guided oral implants insertion
~Immediate Prosthetic loading
~Follow-up"
16138955|NCT01866683|Behavioral|1 month respiratory training|Bhastrika yoga respiratory training: 30 kapalabhati and 1 surya bedhana form 1 bhastrika
16138956|NCT01866683|Behavioral|1 month waiting period|waiting or detraining period
16138957|NCT01866670|Behavioral|spiritual support|-Spiritual Support: deep breathing + guided image + meditation
16138958|NCT01866670|Behavioral|relaxation therapy|Relaxation Therapy: deep breathing
16138959|NCT01866657|Drug|Vasoconstrictor Agents|cerebral desaturations may be treated with IV vasoactives to increase blood pressure or cardiac output at attending physician's descretion.
16138960|NCT01866657|Other|Head/neck repositioning|Assure that arterial and venous neck blood flow is not obstructed related to patient positioning
16138961|NCT01866657|Other|Increase ETCO2|Allow normalization or slight increase in end tidal CO2 to cause selective cerebral vasodilation and increased tissue blood flow/O2 delivery
16138962|NCT01866657|Other|IV fluid bolus|Administer IV fluids to increase preload and cardiac output
16138963|NCT01866657|Drug|Additional anesthesia|By deepening anesthetic there will be a decrease in cerebral metabolic oxygen consumption.
16138964|NCT01866657|Biological|RBC transfusion|By administering RBCs there will be a increase in intravascular volume and cardiac preload and an increase in oxygen carrying capacity
16138965|NCT01866657|Drug|Increase FiO2|Increase FiO2 to improve oxygen delivery to tissue
16138966|NCT01866644|Drug|N-acetylcysteine|Bath transplanted liver with N-acetylcysteine
16138967|NCT01866644|Drug|Saline|Bath saline transplanted liver
16138968|NCT01866605|Drug|Midazolam|Intravenous midazolam 0.3 mg/kg
16138969|NCT01866605|Drug|Normal Saline|Normal saline injection will be given to groups not receiving midazolam
16138970|NCT01866605|Device|Bair Hugger|Forced air warming
16138971|NCT01866592|Drug|Adalimumab|Study participants will receive the FDA-approved dosing schedule for Adalimumab (Humira): an initial dose of 80mg followed by a 40mg maintenance dose every other week up to 52 weeks.
16138972|NCT01866566|Biological|HBV-3|Give a single 0.5 mL HBV and get blood samples at 0,1.5,4.5 month
16138973|NCT01866566|Biological|HBV-6|Give a single 0.5 mL HBV and get blood samples at 0,1.5,7.5 month
16138974|NCT01866566|Biological|varicella-3|Give 2 doses varicella vaccine (a single 0.5 mL) and get blood samples at 0,1.5,4.5 month
16138975|NCT01866566|Biological|varicella-6|Give 2 doses varicella vaccine (a single 0.5 mL) and get blood samples at 0,1.5,7.5 month
16138976|NCT01866553|Drug|Nilotinib|300 mg capsule BID oral use
16138977|NCT01866553|Drug|Pegylated interferon α-2b|25 - 40 microgram per week for subcutaneous use
16138978|NCT01866540|Drug|FLUENZ|live attenuated influenza vaccine
16138979|NCT01866514|Procedure|proximal humerus intraosseous vascular access|The arm receiving the IO needle is positioned with the arm abducted to shoulder level (in position required for surgery), with the arm rotated inward, into the optimal position, with the palms faced down. Deeply palpate the humerus until the junction of the humeral shaft and the humeral head, the surgical neck is identified; the insertion site is in the surgical neck. With the 45mm IO needle placed perpendicular to the plane of the skin, the IO needle is inserted into the surgical neck using a slightly superior angle of insertion and the needle is inserted to the hub. The stylet will be removed and an EZ-Connect primed with 2% preservative-free lidocaine will be attached to the catheter hub. Aspirate return will be attempted to confirm needle placement within the medullary cavity.
16138980|NCT01866514|Drug|2% preservative-free lidocaine|
16138981|NCT01866514|Device|EZ-IO|
16138982|NCT01866501|Procedure|Proximal Humerus Intraosseous Vascular Access|Using the blended technique, device operators will establish proximal humerus intraosseous vascular access by inserting an IO needle.
16138983|NCT01866501|Device|EZ-IO|
16138984|NCT01866488|Drug|Misoprostol|
16138985|NCT01866488|Other|Placebo|
16138986|NCT01866475|Device|EZ-IO|To have an EZ-IO placed up to 48 hours
16138987|NCT01866462|Other|NM504|NM504 is a medical food designed to shift the dysbiota reported in type 2 diabetes. The placebo is carboxymethylcellulose prepared to look, taste and mix like NM504.
16138988|NCT01866449|Drug|Cabazitaxel|
16138989|NCT01866436|Other|Multimedia group|Participants are provided with unrestricted access to the online multimedia educational tools for self-directed study (during the study period)
16138990|NCT01866436|Other|Study Day Group|"Participants in the control arm of the study attend a conventional teaching Study Day involving a series of lectures on Open and Laparoscopic Anterior Resection"
16138991|NCT01866423|Drug|orteronel|Given PO
16138992|NCT01866423|Other|laboratory biomarker analysis|Correlative studies
16138993|NCT01866410|Drug|Cabozantinib S-malate|Given PO
16138994|NCT01866410|Drug|Erlotinib Hydrochloride|Given PO
16138995|NCT01866410|Other|Laboratory Biomarker Analysis|Correlative studies
16138996|NCT01866397|Other|Cidofovir pharmacokinetics|Blood samples were drawn before and 15, 30, 60, 120, 240, 360, 720 and 1440 minutes after the start of the cidofovir infusion. Plasma and ultrafiltration samples were collected from the outlet of the ultrafiltrate compartment of the hemofilter.
16138997|NCT01866384|Procedure|mild induced hypothermia|Patients with intraparancymal hemorrhage within 6 hours of onset will be randomized to either the mild induced hypothermia group or the normal temperature group (control). In this arm, the patient will have 72 hours of Targeted Temperature Managment to mild induced hypothermia (32-34 degrees Celcius).
16138998|NCT01866384|Other|Normal Temperature|In this arm, the patient will have standard of care intraparenchymal hemorrhage management per institutional policy, with normal body temperature management (36-37 degrees Celcius).
16138999|NCT01866371|Procedure|Retinal imaging|Retinal imaging procedures include adaptive optics imaging, optical coherence tomography and fundus photography.
16139001|NCT01866358|Procedure|Umbilical vein infusion|Using umbilical vein infusion for resustation in this group
16139002|NCT01866345|Procedure|Surgically facilitated Orthodontic treatment|Surgically facilitated Orthodontic treatment in the mandibular anterior region
16139003|NCT01866345|Procedure|Conventional orthodontic treatment|Conventional orthodontic Procedure
16139004|NCT01866332|Other|Conventional Physical Therapy|Combination of manual therapy techniques, general exercises and specific exercises for spinal segmental stabilization. Patients will receive 10 sessions of treatment over a period of five weeks (two sessions/week). The treatment will be tailored to the patient presentation (i.e. pragmatic treatment).
16139005|NCT01866332|Device|Kinesio Tex Gold ( Kinesiotaping )|Kinesiotaping intervention is based upon the use of specific elastic tapes (known as Kinesio Tex Gold) that are applied with a certain amount of tension fixed to the skin of patients with the target muscles in a stretched position. The tapes will be placed over the superficial back muscles (erector spinae muscles).
16139006|NCT01866319|Biological|Pembrolizumab|10 mg/kg IV, administered Q2W or Q3W based upon randomization.
16139007|NCT01866319|Biological|Ipilimumab|3 mg/kg IV Q3W.
16139008|NCT01866306|Biological|RV16UB|RV16UB is administered by spraying an atomized viral suspension into a single nostril. Planned doses of RV16UB in Part 1 are 10 Tissue Culture Infective Dose 50 (TCID50), 100 TCID50, 1000 TCID50 and 10,000 TCID50.
16139009|NCT01866306|Drug|LABA|Asthmatic participants were treated with LABA as part of their standard of care
16139010|NCT01866293|Drug|Cabozantinib (XL184)|
16139011|NCT01866280|Behavioral|Normal sleep|Normal sleep= sleep 2300-0700
16139012|NCT01866280|Behavioral|Normal meals|Normal meal times=approximately 1.5, 5, and 11 h after wake up for breakfast, lunch, and dinner, and snack at 13 h after wake up time
16139013|NCT01866280|Behavioral|Late sleep|Late sleep=sleep at 0230-1030 hours
16139014|NCT01866280|Behavioral|Late meals|Late meal times= approximately 4.5, 7, and 13 h after wake up time for breakfast, lunch and dinner, and snack at 15 h.
16139015|NCT01866267|Drug|Maraviroc|HIV positive patients infected with CCR5 tropic virus that have achieved an undetectable viral load on a non-Selzentry®-containing regimen [Protease Inhibitor (PI)/Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI)/Integrase Inhibitor plus 2 Nucleoside Reverse Transcriptase Inhibitor (NRTI)] are switched to once-daily Selzentry® (600mg qd) plus the same 2 NRTIs previously administered.
16139016|NCT01866254|Drug|Hydromorphone|Injection of 100 mcg hydromorphone into the intrathecal space
16139017|NCT01866254|Drug|Morphine|Injection of 200 mcg of intrathecal morphine
16139018|NCT01866241|Drug|Misoprostol|Is a prostaglandin
16139019|NCT01866228|Other|Consultation Recording|
16139020|NCT01866215|Other|exercise|cycling at 100W during 60 min
16139021|NCT01866215|Dietary Supplement|fructose|isocaloric nutrition with fructose, cream and whey protein during the 24 hour following a glycogen/intramyocellular lipid depleting exercise
16139022|NCT01866215|Dietary Supplement|glucose|isocaloric nutrition with glucose, cream and whey protein during the 24 hour following a glycogen/intramyocellular lipid depleting exercise
16139023|NCT01866189|Other|PET and MRI|F-MISO PET followed by brain MRI (MRI-1)(diffusion, FLAIR, perfusion, TOF)
16139024|NCT01866176|Device|Stabilizing Knee Brace|Brace with no valgus action
16139025|NCT01866176|Device|Valgus Knee Brace|Valgus brace with traditional three point bending system
16139026|NCT01866176|Device|New Knee Brace|Brace with new mechanism to decrease the knee loading.
16139027|NCT01866163|Drug|LEO 90100|
16139028|NCT01866163|Drug|Vehicle|
16139029|NCT01866124|Other|Cash transfer|Recipient of transfers Mothers are the primary recipient of the CT. Cash is transferred using mobile phone credits that can be cashed at specific cash points provided by a telecom company.
16139030|NCT01866111|Drug|YKP3089|
16139031|NCT01866111|Drug|Placebo|
16139032|NCT01866098|Drug|Naltrexone|25 or 50mg (randomized) oral capsule taken once daily for 52 weeks to establish optimal dose for weight loss over the course of the study.
16139033|NCT01866098|Drug|Placebo|
16139034|NCT01866085|Procedure|AdVance® sling procedure|
16139035|NCT01866085|Procedure|ARGUS Sling procedure|
16139036|NCT01866059|Device|Calcium silicate cement|Calcium silicate cement
16139037|NCT01866059|Device|Glass Ionomer Cement|Glass Ionomer Cement
16139038|NCT01866059|Device|Resin Modified Glass Ionomer Cement|Resin Modified Glass Ionomer Cement
16139039|NCT01866046|Behavioral|RESPECT-IPV|rapid HIV testing intervention and behavioral counseling session where identify risks and develop a risk reduction plan
16139040|NCT01866033|Drug|PCI-32765 (Treatment A)|560 mg capsules administered by mouth on Day 1, Period 1
16139041|NCT01866033|Drug|PCI-32765 (Treatment B)|560 mg capsules administered by mouth (without grapefruit juice) on Day 1 during Period 2 or 3 according to randomization schedule
16139042|NCT01866033|Drug|PCI-32765 (Treatment C)|140 mg capsule administered by mouth (with grapefruit juice) on Day 1 during Period 2 or 3 according to randomization schedule
16139043|NCT01866033|Drug|13C6 PCI-32765 (reference)|100 mcg administered intravenously 2 h after study drug
16139044|NCT01866007|Drug|Guselkumab (lyophilized formulation)|Participants will receive a single SC injection of 100 mg guselkumab prepared from lyophilized formulation.
16139045|NCT01866007|Drug|Guselkumab (liquid formulation with PFS-U)|Participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with PFS-U.
16139046|NCT01866007|Drug|Guselkumab (liquid formulation with PFS FID)|Participants will receive a single SC injection of 100 mg guselkumab, liquid formulation with PFS FID.
16139047|NCT01866007|Drug|Guselkumab (liquid formulation)|Participants will receive a single IV infusion of 100 mg guselkumab prepared from liquid formulation.
16139048|NCT01865968|Biological|Inactivated HAV vaccine|Hepatitis A vaccine (Healive), 500 u per dose per 0.5 millilitre. Vaccines will be administered with one-dose or two-dose regimen of the arm 6 months apart in the deltoid muscle.
16139049|NCT01865968|Biological|Live attenuated HAV vaccine|Live attenuated hepatitis A vaccine, 6.50 lgCCID50 per dose per 0.5 millilitre. Vaccines will be administered with one-dose regimen in the deltoid muscle.
16139050|NCT01865955|Procedure|Ultrasound|Ultrasound applied to the lumbar region to determine spinal needle placement.
16139051|NCT01865955|Device|The spinal needle|
16139052|NCT01865942|Procedure|open surgery|The to surgical procedures are individually well know, but the outcome of the procedures in respect to perioperative bleeding and change in quality of life has to our knowledge not been compared.
16139053|NCT01865942|Procedure|Minimal access surgery|The to surgical procedures are individually well know, but the outcome of the procedures in respect to perioperative bleeding and change in quality of life has to our knowledge not been compared.
16139054|NCT01865929|Device|Robotic hysterectomy|Minimally invasive hysterectomy for benign disorders. Comparing robotic hysterectomy with vaginal hysterectomy and traditional laparoscopic hysterectomy
16139055|NCT01865929|Procedure|Vaginal or laparoscopic hysterectomy|Benign hysterectomy performed by traditional minimal invasive procedures.
16139056|NCT01865916|Drug|Polyethylene Glycol (PEG) and 15 mg Bisacodyl|Subjects will be asked to take split dose of 2L PEG and 3 tablets of 5 mg Bisacodyl
16139057|NCT01865916|Drug|Polyethylene Glycol (PEG) + ascorbic acid|Subjects will be asked to take split dose of 2L PEG and vitamin C
16139058|NCT01865851|Device|Classic Face Mask and NuMask|
16139059|NCT01865838|Device|Seprafilm (Sanofi, USA)|Studies have unequivocally shown that Seprafilm is effective in reducing internal adhesion formation after abdominal surgery. In a large scaled randomized controlled trial involving about 1700 patients, Fazio et al. found that the use or Seprafilm reduces the risk of small bowel intestinal obstruction which required operative intervention. The safety profile of Seprafilm has also been nicely demonstrated in a randomized controlled trial by Beck et al. in this study, the authors concluded that within the context of abdomino-pelvic surgery, Seprafilm does not increase the incidence of abdominal/pelvic abscesses in patients after abdomino-pelvic surgery; if anything, the anti-adhesive properties of Seprafilm are such that the authors noted an increased risk of anastomotic complications in patients whose bowel anastomoses were in close contact with Seprafilm.
16139060|NCT01865825|Radiation|Esophageal Barium Xray|"•Fast for 4 hours prior to the Esophagram (upper GI x-ray). You will drink a liquid that has barium or another contrast agent in it. The radiologist will use the X-ray machine to look at your upper GI tract while you drink the contrast liquid. The x-ray exam should take between 10-15 minutes.
~We will have patients complete the Mayo Dysphasia Questionnaire-30 day."
16139061|NCT01865812|Drug|obeticholic acid (OCA)|All subjects will be treated with OCA (oral administration, 10 mg, once daily) for 8 weeks and should continue their prestudy dose of ursodeoxycholic acid (UDCA). After completion of the 8 week Primary Treatment Phase of the study and the 4 week follow up period, during which time subjects do not take OCA, all eligible subjects will be offered the opportunity to enter an open label long term safety extension phase, during which they will receive 10 mg OCA daily for up to 2 years.
16139062|NCT01865773|Procedure|HFR dialysis|HFR is a dialysis technique that combines the processes of diffusion, convection and adsorption. In this double chamber hemodiafiltration system, the ultrafiltrate is reinfused after its passage (and opportune modification) through a resin cartridge.
16139063|NCT01865760|Dietary Supplement|Oral Glucose tolerance test (OGGT)|At baseline subjects will consume 50 g glucose dissolved in water in 10 minutes
16139064|NCT01865760|Dietary Supplement|Liquid mixed meal|At baseline subject will consume the liquid mixed meal in 10 minutes
16139065|NCT01865760|Drug|Octreotide|At baseline subjects will receive Octreotid 100 µg subcutaneous
16139066|NCT01865747|Drug|Cabozantinib tablets|
16139067|NCT01865747|Drug|Everolimus (Afinitor) tablets|
16139068|NCT01865734|Other|Physical therapy after initial podiatry visit|Individuals in the early physical therapy group will receive physical therapy in accordance with the American Physical Therapy Association plantar heel pain practice guidelines and recent evidence in support of manual therapy intervention. Treatment provided will be based on identified impairments and may include manual therapy (joint and soft tissue mobilization/thrust manipulation to the lower half of the body), lower leg and plantar foot specific stretching/self mobilization, foot and lower leg muscle performance training, night splints, taping, over the counter orthotics/heel cup/heel cushion, and iontophoresis. Specific intervention will be selected at the discretion of the treating physical therapist.
16139069|NCT01865734|Other|Usual care provided by podiatry|Individuals in the usual podiatric care group will receive care typical of podiatry management of plantar heel pain. According to practice guidelines, the first 6 weeks of treatment includes foot taping/padding, home stretching exercises, arch support/heel cup, shoe recommendations, oral anti-inflammatories, and corticosteroid injection. The next 6 months may include corticosteroid injection, custom orthotics, night splint, immobilization, and physical therapy. If unresponsive after 6 months of treatment, extracorporal shock wave therapy or a fasciotomy surgery is considered. Additionally, the podiatrist may order radiographs or ultrasound imaging within their scope of practice. Specific intervention will be selected at the discretion of the treating podiatrist.
16139070|NCT01865721|Drug|Entonox|Entonox will be used according to the allocated method
16139071|NCT01865708|Drug|Ethanol Lock|Ethanol lock, utilizing 74% ethanol, will begin within 24 hours of urinary catheter placement. The lock will be done every 24 hours for 1 hour. The volume that will be instilled depends upon the fill volume of the catheter, which is imprinted by the manufacturer on each catheter. Once the alcohol is in the catheter, the proximal end of the catheter will be clamped for 1 hour. After the 1 hour dwell time, the clamp will be removed and the alcohol in the lumen of the catheter will be flushed out by the patient's own urine output.
16139072|NCT01865695|Drug|Creon|Creon is a licensed product, manufactured by Abbott Laboratories, Inc. used for the therapeutic indication of pancreatic exocrine insufficiency. The route of administration is oral, with capsules being taken with main meals without chewing. The most commonly reported adverse reactions to Creon are gastrointestinal disorders of mild or moderate severity (up to 10% of patients). These include nausea, vomiting, constipation, diarrhoea and abdominal distension. An uncommon reaction (<0.01%) of patients may develop skin reactions such as a rash or itching. No additional adverse drug reactions have been identified.
16139073|NCT01865695|Other|Placebo|
16139074|NCT01865669|Drug|Oxytocin|Oxytocin, 10-10mol/L to 10-5mol/L
16139075|NCT01865656|Other|Skills training|Refresher training on Basic Emergency Obstetric and Newborn care
16139076|NCT01865656|Other|Emergency obstetric drills|Emergency obstetric drills to practice timely and appropriate management of postpartum hemorrhage and preeclampsia/eclampsia
16139077|NCT01865656|Other|Revised Case Sheets|Revised case sheets will be introduced to capture the timing and appropriate medical treatment of women in labor and newborns
16139208|NCT01864642|Procedure|osteopathic manipulative treatment (OMT)|
16139078|NCT01865656|Other|Supportive supervision|Quarterly supportive supervision visits each of the intervention first referral units.
16139079|NCT01865656|Other|Referral strengthening|To support referral systems that ensure timely and appropriate treatment for obstetric emergencies
16139080|NCT01865643|Device|GlideScope|The GlideScope is used to assist with difficult tracheal intubation.
16139081|NCT01865630|Drug|Etanercept|Lyophilized powder for reconstitution/ 25 mg/vial. 25 mg subcutaneously starting within 36 hours of SAH, and then receive doses 3.5 days and 7 days later for a total of 3 doses.
16139082|NCT01865617|Biological|Autologous Anti-CD19CAR-4-1BB-CD3zeta-EGFRt-expressing T Lymphocytes|Given IV
16139083|NCT01865617|Other|Laboratory Biomarker Analysis|Correlative studies
16139084|NCT01865604|Device|Anodal tDCS|
16139085|NCT01865604|Device|Cathodal tDCS|
16139086|NCT01865604|Device|sham tDCS|
16139087|NCT01865591|Device|Ultrasound-based Renal Denervation|
16139088|NCT01865578|Device|tDCS|Transcranial direct current stimulation involves the application of weak electric currents to the brain.
16139089|NCT01865578|Device|Sham Stimulation|no electrical stimulation
16139090|NCT01865552|Biological|SB4|SC administration
16139091|NCT01865552|Biological|EU sourced Enbrel|SC administration
16139092|NCT01865552|Biological|US sourced Enbrel|SC administration
16139093|NCT01865539|Device|Custom Foot Orthotic|Custom foot orthotic with custom design pads
16139094|NCT01865539|Device|Sham Orthotic|Leather insert without the custom design pads
16139095|NCT01865526|Dietary Supplement|Six point diet|"The 6-point diet is a list of six items indicating how to modify their dietary habits:
~Do not add salt at table and for cooking;
~Food to avoid: any kind of salami, sausages, cheese and dairy products or canned food;
~Replace noodle or bread with special no-protein food;
~The second course (meat, fish and eggs) are allowed once a day in the usual quantity;
~4-5 servings/day of fruits or vegetables are suggested;
~Once or twice a week the main course may be of normal noodle with legumes instead of the second course, with fruit and vegetables."
16139096|NCT01865526|Dietary Supplement|Low protein diet|Classical low-protein diet prescribed according to the patients' desired body weight (DBW), obtained by multiplying the squared value of the height times a reference BMI value of 23. These diets contained at least 30 kcal/kg/day (25 in overweight patients), with a dietary sodium intake restricted to 2.5 g/day.
16139097|NCT01865500|Drug|Budesonide 4 mg|It will be evaluated at baseline, 24 h, 48 h and before discharge
16139098|NCT01865500|Drug|Budesonide 8 mg|Baseline FEV1 and before discharge FEV1 were evaluated
16139099|NCT01865500|Drug|Metil prednisolone|
16139100|NCT01865487|Biological|H56ug/IC31nmol|H56:IC31 (designated as AERAS-456 for Aeras-sponsored clinical development) contains a fusion protein (referred to as H56 antigen, or H56) of 3 mycobacterial antigens (the early secreted antigens Ag85B and ESAT-6, and the latency antigen Rv2660c) formulated in the Th1-stimulating IC31 adjuvant.
16139101|NCT01865487|Biological|Placebo|Sterile buffer consisting of 10mM Tris and 169mM NaCl at pH 7.4
16139102|NCT01865474|Drug|DLBS1033|1 DLBS1033 tablet 490 mg thrice daily for 2 months
16139103|NCT01865474|Drug|placebo tablet of DLBS1033|1 placebo tablet of DLBS1033 thrice daily for 2 months
16139104|NCT01865448|Dietary Supplement|Omega-3 DHA|Patients take daily 2 tablets of Docosahexaenoic Acid
16139105|NCT01865448|Other|Placebo|Patients in control group take daily 2 placebo capsule
16139106|NCT01865435|Genetic|cord blood sample|
16139107|NCT01865422|Other|parent-proxy QoL chronic cough specific questionnaire (PC-QOL)|
16139108|NCT01865409|Behavioral|Kangaroo Care|Kangaroo care is a technique practiced on newborn, usually preterm, infants wherein the infant is held, skin-to-skin, with an adult.
16139109|NCT01865396|Behavioral|Interventional palliative care|Palliative support team will meet the patient soon after diagnosis of incurable disease and will meet the patient at least once a month. The patient will also receive the standard oncologic care.
16139110|NCT01865396|Behavioral|Standard oncologic care|Patients will receive standard oncologic care.
16139111|NCT01865383|Behavioral|Microfinance and Health Leadership|Microfinance and Health Leadership: Participants will be eligible to receive small loans and business training as part of the microfinance component. Nominated leaders in camps will receive health leadership training on prevention of HIV risk behaviors and gender based violence perpetration, and then pass on knowledge to camp members.
16139112|NCT01865370|Dietary Supplement|Kochujang Pills|Kochujang Pills (34.5g/day)
16139113|NCT01865370|Dietary Supplement|Placebo|Placebo (34.5g/day)
16139114|NCT01865357|Other|Brain MRI - Clinical and cognitive evaluation|"Clinical evaluation (EDSS, MSFC)
~Cognitive evaluation with tests of information processing speed, attention, working memory, episodic memory and executive functions, assessment of confounding factors (depression (BDI) and anxiety (HAD), mood (EHD), fatigue (M-FIS) and assessment of quality of life (SEP-59)
~Brain MRI (3 Tesla): FLAIR, 3D MPRAGE T1 and DTI"
16139115|NCT01865357|Other|Eye movement|Assessment of eye Movements (EyeBrain software) for only the group of 15 healthy subjects at baseline and at 12 months
16139116|NCT01865331|Drug|insulin degludec|Single dose administered subcutaneously (s.c., under the skin).
16139117|NCT01865331|Drug|placebo|Administered subcutaneously (s.c., under the skin)
16139118|NCT01865331|Drug|insulin degludec/insulin aspart 50|Single dose of IDegAsp 50 administered subcutaneously (s.c., under the skin)
16139119|NCT01865318|Drug|insulin degludec|Administered subcutaneously (s.c., under the skin)
16139120|NCT01865305|Drug|insulin degludec/insulin aspart 30|Single dose administrated subcutaneously (s.c., under the skin).
16139121|NCT01865305|Drug|insulin degludec/insulin aspart 40|Single dose administrated subcutaneously (s.c., under the skin).
16139122|NCT01865305|Drug|insulin degludec/insulin aspart 50|Single dose administrated subcutaneously (s.c., under the skin).
16139123|NCT01865305|Drug|insulin degludec|Single dose administrated subcutaneously (s.c., under the skin).
16139124|NCT01865305|Drug|insulin aspart|Single dose administrated subcutaneously (s.c., under the skin).
16139125|NCT01865305|Drug|biphasic insulin aspart 30|Single dose administrated subcutaneously (s.c., under the skin) as comparator.
16139126|NCT01865305|Drug|insulin degludec/insulin aspart 40|Single dose administrated subcutaneously (s.c., under the skin).
16139957|NCT01858961|Drug|Pegylated Interferon|Once a week
16139127|NCT01865305|Drug|insulin degludec/insulin aspart 50|Single dose administrated subcutaneously (s.c., under the skin).
16139128|NCT01865305|Drug|biphasic insulin aspart 30|Single dose administrated subcutaneously (s.c., under the skin).
16139129|NCT01865292|Drug|insulin degludec|Three single doses administrated subcutaneously (s.c., under the skin) on three separate dosing visits. Dose will vary when administered to subjects with type 1 and type 2 diabetes, respectively.
16139130|NCT01865292|Drug|insulin glargine|Three single doses administrated subcutaneously (s.c., under the skin) on three separate dosing visits. Dose will vary when administered to subjects with type 1 and type 2 diabetes, respectively.
16139131|NCT01865279|Drug|insulin degludec|Ascending single doses - 5 dose levels. Escalation to next dose level will be performed following evaluation of safety data.
16139132|NCT01865279|Drug|placebo|Ascending single doses - 5 dose levels
16139133|NCT01865279|Drug|insulin degludec|A single dose corresponding to that of isophane human insulin
16139134|NCT01865279|Drug|isophane human insulin|A single dose of 0.4 IU/kg is administered to subjects with type 1 diabetes while a single dose of 0.6 IU/kg is administered to subjects with type 2 diabetes
16139135|NCT01865266|Drug|Ulinaststin for injection|
16139136|NCT01865266|Drug|placebo|
16139137|NCT01865253|Device|Renal Denervation|Renal Denervation
16139138|NCT01865240|Device|Renal Denervation|Renal Denervation Catheter
16139139|NCT01865227|Behavioral|Group Counseling|
16139140|NCT01865201|Drug|Edaravone|Be used at a dose of 30mg, intravenously, twice per day, for 14 days.
16139141|NCT01865201|Other|Common fundamental management|common fundamental management, which was as follows: ①Methylprednisolone, administered by intravenous infusion at a 500mg daily for 3 consecutive days and then gradually tailed off in 30 days with administration of oral prednisolone. ②Dehydration drugs.
16139142|NCT01865188|Drug|LCZ696|Experimental monotherapy doses
16139143|NCT01865188|Drug|Amlodipine|Active comparator monotherapy doses
16139144|NCT01865188|Drug|LCZ696 and amlodipine combination|Experimental combination doses
16139145|NCT01865188|Drug|Placebo|Placebo comparator dose
16139146|NCT01865175|Drug|ionic iron|Subjects will take ionic iron daily for 7 days followed by 7 days of no medicine followed by 7 days of heme iron.
16139147|NCT01865175|Drug|heme iron polypeptide|Subject will take heme iron daily for 7 days followed by 7 days of no medicine followed by 7 days of ionic iron.
16139148|NCT01865162|Other|ketogenic diet|Treatment will consist of ketogenic diet. KD will consist of 4:1 [fat] : [protein+carbohydrate] weight ratio with 1600 kcal restriction. The diet will be supplemented with vitamins, calcium, phosphorus, zinc and selenium supplements to meet the requirements of US Dietary Reference Intakes (DRI) standard.
16139149|NCT01865149|Procedure|retrobulbar ultrasound|both optic nerve sheath diameter (the posterior 3mm of the papilla), 5 individual measurement
16139150|NCT01865136|Other|Medical Post Abortion Care|Women with incomplete abortion is diagnosed and treated with misoprostol
16139151|NCT01865123|Behavioral|Transcendental Meditation|A standard 7 step course will be offered including an introductory and preparatory lectures, personal one-on-one instruction with a certified TM teacher followed by 3 consecutive days of classes on how to meditate correctly and effortlessly, how to understand mechanisms of stress release and sequential development to higher levels of human consciousness and enjoying ones full potential. Followup meetings will provide checking of TM practice, sharing of group experiences with the TM practice and knowledge to motivate and inspire continued regularity with the practice. The certified TM instructor will have experience with PTSD in this veteran population.
16139152|NCT01865123|Behavioral|Prolonged Exposure|Prolonged exposure therapy, a specific form of cognitive behavioral therapy, is considered the standard psychotherapy treatment for PTSD . The delivery of PE will be by a trained study therapist. There will be 16 individual sessions provided to each participant. Homework will include relaxation and breathing exercises and anxiety diaries.
16139153|NCT01865123|Behavioral|Educational control|This group will receive group-administered didactic health education specific to the PTSD veterans population. It will include emphasis on healthy lifestyle changes to promote more positive mental and physical health. The classes will be matched with the TM and PE interventions to control for time, instructor attention and other non-specific factors.
16139154|NCT01865110|Drug|R-CHOP|R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine and prednisone) administered in 3 week cycles for 8 cycles
16139155|NCT01865110|Drug|R-CHOP / R-HAD|R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone) administered in 3 week cycles for 3 cycles R-HAD (rituximab, cytarabine, dexamethasone) administered in 3 week cycles for 4 cycles alternating
16139156|NCT01865110|Drug|Rituximab|Rituximab SC 1400 mg every 8 weeks for 24 months
16139157|NCT01865110|Drug|Lenalidomide|Lenalidomide 15 mg 3 weeks every 4 weeks for 24 months
16139158|NCT01865097|Behavioral|Relaxation guided imagery|An individualized relaxation guided imagery session will be conducted. After the session patients will be given a CD with the relaxation guided imagery and asked to listen to it at home.
16139159|NCT01865097|Behavioral|Relaxing music|An individualized session of listening to relaxing music will be conducted. After the session patients will be given a CD with the relaxing music and asked to listen to it at home.
16139160|NCT01865084|Drug|Tadalafil|Administered orally
16139161|NCT01865084|Drug|Placebo|
16139162|NCT01865071|Procedure|loop ileostomi|
16139163|NCT01865019|Device|mechanical ventilation|
16139164|NCT01864993|Dietary Supplement|gluten|The enrolled patients will be invited to follow a gluten free diet. Patients responsive to the diet will be invited to assume gluten or placebo following a double blind with cross over scheme
16139165|NCT01864993|Dietary Supplement|Placebo|Patients responsive to the diet will be invited to blindly assume gluten or placebo following a double blind with cross over scheme
16139166|NCT01864980|Procedure|blood transfusion, intermittent Hbsatlab measurement|In the Hbsatlab group, RBC administration and its timing will be based on intermittent Hbsatlab measurement (routine care)
16139167|NCT01864980|Procedure|blood transfusion, based on continuous SpHb readings|RBC administration and its timing will be based on continuous SpHb readings while Hbsatlab values, measured every 30 min. by an objective observer, will not be visible to the attending anaesthetist.
16139252|NCT01864317|Other|Applanation Tonometry|Measurement of Intraocular Pressure
16139168|NCT01864954|Behavioral|Web+phone|We propose to evaluate the feasibility, acceptability, and efficacy of a Web+phone treatment program in a small, randomized, controlled pilot study. Women who have quit smoking during pregnancy will be randomly assigned to either (a) an Enhanced Web+phone intervention or (b) a Basic Web Information-Only control condition.
16139169|NCT01864941|Procedure|Catheter venography with balloon venoplasty|All eligible patients will undergo catheter venography with balloon venoplasty and/or sham at baseline and at week 48 (i.e. Cross over design) followed by clinical and radiologic observation for a minimum of 48 weeks after each procedure.
16139170|NCT01864941|Device|Catheter venography with balloon venoplasty and balloon|
16139171|NCT01864915|Drug|Prucalopride|Prucalopride 2mg daily starting three days before the colon capsule study (total of 4 doses with the last at 0800hrs on day of colon capsule study)
16139172|NCT01864915|Procedure|Colon Capsule|Colon capsule procedure performed day prior to colonoscopy, at 0800 hrs on day 4.
16139173|NCT01864902|Biological|CART33 cells|genetically modified lymphocyte therapy
16139174|NCT01864902|Biological|anti-CD33 CART|
16139175|NCT01864902|Biological|anti-CD33 CAR T cells|
16139176|NCT01864889|Biological|anti-CD19-CAR vector-transduced T cells|genetically engineered lymphocyte therapy
16139177|NCT01864876|Biological|GLA-AF|Glucopyranosyl Lipid A (GLA) in an aqueous formulation (AF).
16139178|NCT01864876|Biological|GLA-SE|Glucopyranosyl Lipid A (GLA) in a stable oil-in-water emulsion (SE).
16139179|NCT01864876|Biological|EM060G (SE)|The same stable oil-in-water emulsion (SE), but without GLA.
16139180|NCT01864863|Drug|HGP1206|One Bosentan 125 mg tablet
16139181|NCT01864863|Drug|Traclear|Two Bosentan 62.5 mg tablets
16139182|NCT01864850|Radiation|Standard RT|70 Gy / 7 weeks / 2 Gy per fraction
16139183|NCT01864850|Radiation|Hypofractionated RT|55 Gy / 7 weeks with 2 weeks interruption / 3 Gy per fraction until 30 Gy, after interruption 2.5 Gy per fraction until 55 Gy
16139184|NCT01864824|Drug|methyl donor|The design will include a 2 week placebo run-in followed by a baseline blank study (2-hrs exposure to medical air) to provide benchmarks for all assessed variables. Participants will then receive a 4-week placebo treatment before the first PM2.5 exposure study. A 4-week methyl-donor treatment (Dose: 2.5 mg of folic acid, 50 mg of vitamin B6, and 1 mg of vitamin B12 once a day) will precede the 2nd PM2.5 exposure.
16139185|NCT01864824|Drug|Placebo|Placebo
16139186|NCT01864811|Behavioral|Baby-CIMT|Baby-CIMT is a very much modified model of constraint induced movement therapy for infants. It is developed to suit small children and their needs of stimulation. The infant should wear a comfortable glove on the less affected hand, while stimulating the use of the affected hand 30 minutes per day during 2 periods of 6-weeks training before 12 month. The hand training provides the baby with amusing and easily handled toys.
16139187|NCT01864811|Behavioral|Baby-Massage|For baby massage, there will be a special instructional course by a health professional certified for baby massage. Massage should be given every day during 2 periods of 6 weeks. Families will be responsible for the massage.
16139188|NCT01864798|Drug|Denosumab|
16139189|NCT01864785|Procedure|Fixation Combined With Fusion|Articular process fusion with bone graft was carried out after screw fixation
16139190|NCT01864785|Procedure|Fixation Alone|Use the Posterior approach to achieve the reduction and stabilization by pedicle screw and rod alone
16139191|NCT01864772|Drug|Carbo, 5FU, Cetuximab|"6 cycles (1 cycle = 21 days) of: carboplatin AUC 5, 5FU D1-4 1000mg/m²/d, every 21 days cetuximab weekly (400 mg/m² the first week of treatment and then 250 mg/m²/w)
~Maintenance by cetuximab 500 mg/m² every 2 weeks until progression or toxicity"
16139192|NCT01864759|Biological|ICOVIR-5|
16139193|NCT01864746|Drug|Palbociclib PD-0332991|palbociclib at a dose of 125 mg once daily, day 1 to day 21 followed by 7 days off treatment in a 28-day cycle
16139194|NCT01864746|Drug|Placebo|Arm B: Placebo of palbociclib once daily day 1 to day 21 followed by 7 days off treatment in a 28-day cycle for thirteen cycles
16139195|NCT01864733|Other|Physical rehabilitation (exercise).|
16139196|NCT01864720|Behavioral|Professionally-administered cognitive-behavioral therapy for insomnia (CBT-I)|The treatment content will be the same whether it is administered by a professional or self-administered. This multimodal approach combines behavioural (i.e., stimulus control therapy, sleep restriction), cognitive (i.e., cognitive restructuring), and educational (i.e., sleep hygiene) strategies that are administered over a 6-week period.
16139197|NCT01864720|Behavioral|Web-based cognitive-behavioral therapy for insomnia (CBT-I)|The treatment content will be the same whether it is administered by a professional or self-administered. Each week, the patients will first have to read written information on the website, and then watch a video capsule (duration between 5 and 20 min each). The treatment material will be identical to the video (DVD)-based CBT-I that we previously developed. Patients will complete their daily sleep diary electronically on the website and the content will be interactive. It will include the sending of automated emails to remind participants to complete the treatment tasks and encourage adherence, provision of tailored feedback (e.g., texts, charts) based on the information that they provide in their sleep diary, as well as quizzes with automated correction to reinforce patients' understanding of the content.
16139198|NCT01864707|Other|Usual care + acupuncture|Patients of this group receive a standardized acupuncture treatment over 12 weeks in addition to usual care
16139199|NCT01864707|Other|usual care+mbsr|Patients of this group receive mindfulness based stress reduction in addition to usual care
16139200|NCT01864707|Other|usual care|Patients in this group will follow the same treatment for fatigue they received at study entry
16139201|NCT01864694|Behavioral|TLC-Diet|Participants receive diet intervention through an automated telephone system
16139202|NCT01864694|Behavioral|WEB-Diet|Participants receive diet intervention through a web-based system
16139203|NCT01864694|Other|Assessment-only control|Assessment-only control
16139204|NCT01864681|Drug|Gefitinib and Metformin|Gefitinib will be administered once every day. If subject has complete response, partial response, stable disease, or unacceptable toxicity.
16139205|NCT01864681|Drug|Gefitinib and placebo|Gefitinib will be administered once every day. If subject has complete response, partial response, stable disease, or unacceptable toxicity.
16139206|NCT01864655|Drug|saracatinib|oral drug given to experimental group
16139207|NCT01864655|Drug|Placebo|Placebo given to placebo group
16139209|NCT01864642|Procedure|osteopathic manipulative treatment (OMT)|OMT is a form of manual medicine performed by osteopathic physicians
16139210|NCT01864629|Behavioral|Focused contraception counseling|This intervention will be provided to those randomized to the intervention group only. This counseling will follow a pre-written, structured script describing all contraceptive methods in rank order starting with most effective to least effective in preventing unplanned pregnancy.
16139211|NCT01864616|Dietary Supplement|Vitamin D3|
16139212|NCT01864603|Other|Universal ART in a streamlined care model|immediate ART start for all HIV+ in community with streamlined care
16139213|NCT01864603|Other|Annual Community Health Campaigns|HIV and multi-disease testing for all community members
16139214|NCT01864603|Other|Targeted PrEP and Targeted testing interventions|
16139215|NCT01864603|Other|Baseline community-based HIV and multi-disease testing|HIV and multi-disease testing for all community members at baseline only
16139216|NCT01864590|Device|Vacuum Pack|Vacuum Pack Technique described by Barker et al.
16139217|NCT01864590|Device|Double Sylo Bag - Mesh Protocol|"double sylo bag, one underneath the fascia and the other sutured to the skin, at the initial operation.
~At subsequent surgeries once the abdomen is clean the investigators leave the same subfascial sylo bag and use a prolene mesh attached to the fascia. This mesh is resutured every day until the abdominal fascia is approximated enough to permit closure"
16139218|NCT01864577|Other|Negative Pleural Suction at -20 cm H2O|
16139219|NCT01864577|Other|Water seal|
16139220|NCT01864564|Other|Early Screen|Women will be randomized to be screened for gestational diabetes at 14-19.9 weeks gestation (early=intervention) versus routine screening at 24-28 weeks.
16139221|NCT01864551|Drug|Lamotrigine|
16139222|NCT01864551|Drug|Olanzapine|
16139223|NCT01864538|Drug|TH-302|480 mg/m2 by iv infusion over 30 - 60 min on Days 1, 8, and 15 of a 28-day cycle.
16139224|NCT01864525|Drug|Octanoic acid|
16139225|NCT01864525|Drug|Inactive capsule|
16139226|NCT01864499|Procedure|ultrasound measurement of variations in the diameter of the sheath of the optic nerve|pre-and postoperative optic nerve and J2 and J5 for all patients
16139227|NCT01864486|Device|Intelligent Retinal Implant System|
16139228|NCT01864473|Other|Kshar Sutra|The Kshar Sutra is a standard medicated thread smeared with Kshar of Apamarga (Achyranthus Aspera), Shnuhi (Euforbia Nerrifolia) which has quality of cutting and Haridra (Curcuma longa) which is used as a antiseptic. This combination of medicine on the thread helps in debridement and simultaneously healing of track. After conformation of vaginal fistula the track was cleaned with betadine and Hydrogen peroxide. The Kshar Sutra was tied covering the entire underlying track for simultaneous cutting and healing under all aseptic precaution. The patient was discharged on the next day of procedure. Patient was advice for Sitz bath with lukewarm water. The Kshar Sutra was changed weekly.
16139229|NCT01864460|Behavioral|lifestyle modification|Structured weight loss or weight maintenance and aerobic exercise intervention for 12 months or standard of care weight and exercise management
16139230|NCT01864447|Behavioral|VTE REHABILITATION: High-Caloric Expenditure Exercise Training (HCE) and The Dietary Behavioral Weight Loss Intervention (BWL)|
16139231|NCT01864434|Device|Stryker posterior cruciat retaining (PCR) total knee arthroplasty (TKA)|The fluoroscopy procedure itself is used as a means of data collection and is not the intervention under investigation; therefore, the study is observational and not interventional.
16139232|NCT01864434|Device|Zimmer PCR TKA|The fluoroscopy procedure itself is used as a means of data collection and is not the intervention under investigation; therefore, the study is observational and not interventional.
16139233|NCT01864408|Other|"Usual practice counseling"|
16139234|NCT01864408|Other|"Standard usual practice clinical counseling with the pelvic organ prolapse web-based tool (iPad)."|"After a new patient history and physical exam, with POP-Q exam, the subjects specific exam findings are entered into the Interactive Pelvic Organ Prolapse Quantification (POP-Q) Program. The program then constructs a cartoon of the subjects physical exam findings. This image is then used in counseling in addition to standard usual practice counseling."
16139235|NCT01864395|Procedure|Centrifugation Method|Currently used to separate whole blood into red blood cells (RBCs) and plasma components. The RBCs are washed with normal saline and re-infused into the patient, while the plasma portion is discarded.
16139236|NCT01864395|Procedure|Online MUF|Hemofilter is used online while the heart-lung machine is connected to the patient.
16139237|NCT01864395|Procedure|Offline MUF|Hemofilter is used offline when the heart-lung machine is not connected to the patient.
16139238|NCT01864382|Other|Core stability|Core stability 5 days a week during 5 weeks
16139239|NCT01864382|Other|Standard Physiotherapy Exercises|Standard Physiotherapy Exercises is a conventional treatment program 5 days a week during 5 weeks
16139240|NCT01864369|Behavioral|eCounseling + Usual Care|"This intervention will use film vignettes and interactive web pages. The e-counseling messages will promote: (i) validation of the subject's stage of readiness for behavior change, (ii) collaborative participation by means of subject-selected menus, (iii) reinforcement of change talk to resolve ambivalence, (iv) use of self-help information and e-tools for self-monitoring of targeted self-care behaviors, and (v) development of cognitive-behavioral skills to build and strengthen efficacy. Messages will be proactively sent to Controls according to the following schedule: weekly for months 1 to 4, bi-weekly for months 5 to 8, and monthly for months 9 to 12."
16139241|NCT01864356|Drug|NT100|
16139242|NCT01864356|Drug|Placebo|
16139243|NCT01864343|Device|EMCOOLS flex pad; Philips Innercool RTx|Surface cooling with EMCOOLS flex pads (out-of-hospital); Infusion of 1000ml to 2000ml of cold saline (out-of-hospital); central-venous cooling (Philips Innercool RTx)
16139244|NCT01864330|Device|Thealoz Duo®|Eye Drops
16139245|NCT01864330|Device|Hyabak®|Eye Drops
16139246|NCT01864330|Device|Hydrabak®|Eye Drops
16139247|NCT01864317|Device|7-Tesla MRI|High resolution functional and structural imaging of the visual pathway
16139248|NCT01864317|Other|Optical Coherence Tomography|Measurement of retinal nerve fiber thickness
16139249|NCT01864317|Other|Heidelberg Retina Tomography|Measurement of retinal nerve fiber thickness
16139250|NCT01864317|Other|Scanning Laser Polarimetry|Measurement of retinal nerve fiber thickness
16139251|NCT01864317|Other|Humphrey Perimetry|Visual Field Testing
16139253|NCT01864291|Device|Nucleus 24 (discontinued) and ABI541 Auditory Brainstem Implants (ABI)|Nucleus ABI541 Auditory Brainstem Implant (ABI) surgery followed by device activation, testing, and clinical assessment for five years following surgery.
16139254|NCT01864278|Device|Lutonix Drug Coated Balloon|Subject will receive treatment with the Lutonix Drug Coated Balloon
16139255|NCT01864265|Drug|Certolizumab Pegol|Certolizumab Pegol (Cimzia®) is an engineered, humanized antibody-Fab'-fragment with specificity for human TNF-α, that is conjugated to polyethylene glycol (PEG). Certolizumab Pegol (Cimzia®) is a humanized antibody-Fab'-fragment that is produced in Escherichia coli and subsequently PEGylated to prolong its circulating half-time to be similar to that of an intact mAB. Certolizumab Pegol has a high affinity for TNF α with a Kd90pM and is an effective TNF α inhibitor. Certolizumab pegol does not neutralize TNFß (lymphotoxin), a related cytokine, and does not activate complement or kill cells via antibody-dependent cellular toxicity.
16139256|NCT01864265|Drug|Placebo|Placebo will be administered according to the label of the biological
16139257|NCT01864252|Other|Remote ischaemic preconditioning|3 cycles of 5 minutes to arm and legs
16139258|NCT01864252|Drug|IV Normal saline|Normal saline IV started prior to knife to skin at a rate of 2-5 mls/h and stopped just after weaning off bypass.
16139259|NCT01864252|Drug|IV Glyceryl trinitrate 2-5ml/h|IV GTN given during surgery started prior to knife to skin and stopped after weaning off cardiopulmonary bypass.
16139260|NCT01864239|Other|Medicines Advice Service|"The intervention consists of:
~Telephone consultations with a pharmacist
~Follow-up tailored written information
~A medicine reminder chart"
16139261|NCT01864226|Drug|RO5545965|Multiple ascending doses
16139262|NCT01864226|Drug|placebo|Multiple ascending doses
16139263|NCT01864213|Drug|Ametop cream|
16139264|NCT01864200|Biological|Crotalidae polyvalent immune fab (ovine)|crotalidae antivenom
16139265|NCT01864200|Biological|Placebo|Saline placebo
16139266|NCT01864187|Drug|Dexmedetomidine|The volunteers would receive a dosage of dexmedetomidine by 1μg/kg.
16139267|NCT01864174|Drug|Metformin XR|
16139268|NCT01864174|Drug|Metformin IR|
16139269|NCT01864174|Drug|Placebo matching with Metformin XR|
16139270|NCT01864174|Drug|Placebo matching with Metformin IR|
16139271|NCT01864161|Drug|gluconate iron|FERLIXIT fl 15mg/kg divided into weekly administrations of 125mg up to a maximum of 1000mg
16139272|NCT01864161|Drug|Liposomal iron|Sideral forte 30 mg/die
16139273|NCT01864148|Drug|BIIB033|
16139274|NCT01864148|Other|Placebo|
16139275|NCT01864148|Drug|Avonex|
16139276|NCT01864135|Device|3T MRI (Magnetom Verio 3T, Erlangen, Germany)|
16139277|NCT01864135|Device|Transrectal ultrasound (Bk Medical Pro Focus Ultraview 2202 system)|
16139278|NCT01864109|Drug|Cyclophosphamide|
16139279|NCT01864109|Device|Doxorubicin|
16139280|NCT01864109|Drug|Vincristine|
16139281|NCT01864109|Drug|Ifosfamide|
16139282|NCT01864109|Drug|Etoposide|
16139283|NCT01864109|Procedure|Surgery|
16139284|NCT01864109|Radiation|Radiation Therapy*|If local control includes RT, RT should be given concurrently with chemotherapy cycles
16139285|NCT01864109|Drug|Temozolomide|
16139286|NCT01864109|Drug|Irinotecan|
16139287|NCT01864109|Drug|Mesna|Mesna 2,100 mg/m2 (or 70 mg/kg if < 10 yrs of age) administered intravenously in concordance with institutional pediatric administration guidelines.
16139288|NCT01864109|Drug|Dexrazoxane|Dexrazoxane 375 mg/m2 intravenously over approximately 15-30 minutes and as clinically indicated. To be administered immediately prior to doxorubicin.
16139289|NCT01864109|Drug|G-CSF|G-CSF-to be administered after the completion of appropriate chemotherapy cycles as per institutional guidelines.
16139290|NCT01864096|Drug|Metformin|One month run-in of 850mg metformin once daily, followed by 850mg twice daily of metformin for 35 months. Total time is 36 months.
16139291|NCT01864096|Drug|Placebo|One month run-in of placebo tablet once daily, followed by twice daily for 35 months. Total time is 36 months.
16139292|NCT01864083|Procedure|Positron Emission Tomography (PET)|
16139293|NCT01864083|Drug|Fluorine-18 labeled 1-amino-3-fluorocyclobutane-1-carboxylic acid (FACBC)|
16139294|NCT01864083|Procedure|Positron emission mammography (PEM) When available|
16139295|NCT01864083|Procedure|MR|
16139296|NCT01864070|Other|TheraSphere|TheraSphere glass microspheres containing Y-90 injected into catheter, and will deliver 120 Gy to entire tumor bearing portion of the liver given at a single session on Cycle 1 Day 15.
16139297|NCT01864070|Drug|Everolimus|"Starting dose: is 5 mg by mouth daily for cycles 1 and 2. Patients will receive standard dose of Everolimus at 10 mg by mouth daily starting cycle 3 day 1.
~Dose Expansion Cohort Starting Dose: Maximum tolerated dose from dose escalation cohort."
16139298|NCT01864070|Other|Phone Call|At least 1 time a week by phone or at the clinic for up to 30 days after last everolimus dose, study staff will follow up. Patient asked about any side effects they may have had. The call should last about 10-15 minutes.
16139299|NCT01864057|Drug|thiamine hydrochloride 100 mg|
16139300|NCT01864018|Drug|Cyclophosphamide|Given PO
16139301|NCT01864018|Drug|Dexamethasone|Given PO
16139302|NCT01864018|Drug|Ixazomib Citrate|Given PO
16139303|NCT01864018|Other|Laboratory Biomarker Analysis|Correlative studies
16139304|NCT01864018|Other|Pharmacological Study|Correlative studies
16139305|NCT01864018|Other|Quality-of-Life Assessment|Ancillary studies
16139306|NCT01864018|Other|Questionnaire Administration|Ancillary studies
16139307|NCT01864005|Drug|Ticagrelor|90mg tablets. loading dose of 180mg ticagrelor tablets (two 90mg tablets) taken orally, followed by 90mg of ticagrelor 12 hours after the first dose. Duration of treatment: 6 weeks.
16139308|NCT01864005|Drug|Clopidogrel|75mg capsule. loading dose of 600mg clopidogrel capsules (eight 75mg capsules) taken orally, follow by 75mg of clopidogrel capsules orally od. Duration of treatment: 6 weeks.
16139309|NCT01863966|Other|hot water drinking therapy|Drink 200ml hot water 3min before and after a meal. Swallow food with hot water and drink 200ml hot water before sleep
16139310|NCT01863966|Procedure|Pneumatic dilation|Patients who are unsatisfied with hot water drinking therapy are to receive standard pneumatic dilation under endoscope
16139958|NCT01858948|Drug|Omega|Omega-3 supplements
16139311|NCT01863953|Drug|Fixed-Combination Bimatoprost/Brimonidine|One drop fixed-combination bimatoprost/brimonidine in each eye twice daily for 6 weeks.
16139312|NCT01863953|Drug|Bimatoprost Ophthalmic Solution 0.01%|One drop bimatoprost ophthalmic solution 0.01% in each eye in the evening for 6 weeks.
16139313|NCT01863953|Drug|Vehicle Ophthalmic Solution|One drop vehicle ophthalmic solution in each eye in the morning daily for 6 weeks.
16139314|NCT01863953|Drug|Brimonidine Tartrate Ophthalmic Solution 0.2%|One drop brimonidine tartrate ophthalmic solution 0.2% in each eye twice daily for 6 weeks.
16139315|NCT01863940|Device|Wound Catheter|Wound catheter placement in split thickness skin graft donor site on the thigh with continuous infusion of procaine 0.5% at 4-5cc/hr for 48 hours.
16139316|NCT01863927|Other|Research intervention|After heat acclimation the participant will be randomly exposed to 4 conditions during four separate consecutive days: 1) walking on a treadmill for two hours in hot-wet conditions (30OC, 70% RH) while wearing military uniforms and a vest (control group); 2) walking on a treadmill for two hours in hot-dry conditions (40OC, 30% RH) while wearing military uniforms and a vest (control group); 3) walking on a treadmill for two hours in hot-wet conditions (30OC, 70% RH) while wearing military uniforms and a vest with a ventilator (experimental group); 4) walking on a treadmill for two hours in hot-dry conditions (40OC, 30% RH) while wearing military uniforms and a vest with a ventilator (experimental group)
16139317|NCT01863914|Drug|Rosuvastatin|Arteriovenous fistula surgery was performed after 1-week treatment with placebo or Rosuvastatin (randomized, double blind). The intervention drug treatment continues for 3 more weeks after creation of AV fistula.
16139318|NCT01863901|Device|Treatment with Cryo-Touch III device|
16139319|NCT01863888|Drug|teriflunomide HMR1726|Pharmaceutical form:tablet Route of administration: oral
16139320|NCT01863888|Drug|cholestyramine|Pharmaceutical form:powder Route of administration: oral
16139321|NCT01863888|Drug|charcoal|Pharmaceutical form:granule Route of administration: oral
16139322|NCT01863862|Radiation|Radiochemotherapy or radiotherapy|"50 Gy, 2 Gy per fraction with simultaneous 5-Fu and leucovorin or 5 x 5 Gy for patients unfit for chemotherapy.
~Patients with complete clinical response 8-10 weeks after radiotherapy will be closely observed and rescue surgery will be performed in a case of local recurrence.
~Patients with persistent tumour 8-10 weeks after radiotherapy will undergo transanal endoscopic microsurgery or total mesorectal excision. After transanal endosciopic microsurgery, patients with ypT0-1 disease and negative surgical margins will be closely observed and rescue total mesorectal excision will be performed in a case of local recurrence; those with ypT2-3 disease or with positive margin will undergo immediate conversion to total mesorectal excision."
16139323|NCT01863849|Biological|Vaccination with Fluval AB suspension for injection|Single intramuscular injection with Fluval AB suspension for injection in both age groups
16139324|NCT01863836|Procedure|Fluoroscopy|
16139325|NCT01863836|Procedure|Radial EBUS-guided biopsy|
16139326|NCT01863823|Drug|Amoxicillin and Tetracyclines|202 symptomatic and 148 asymptomatic individuals were recruited and tested using Saliva H. pylori antigen tests (HPS), H. pylori flagellin (HPF), the urea breathe test (UBT) and the polymerase chain reaction (PCR) test. Test subjects also received various treatments.
16139327|NCT01863823|Drug|Mouth washing|Two time washing mouth per day
16139328|NCT01863810|Drug|KW21052|1 Tablet contains 300mg of pregabalin. Oral, once a day, for 8 weeks.
16139329|NCT01863810|Drug|Lyrica|1 Capsule contains 150mg of pregabalin. Oral, twice a day, for 8 weeks.
16139330|NCT01863810|Drug|Lyrica (low dose)|1 Capsule contains 75mg of pregabalin. Oral, twice a day, for 1 week.
16139331|NCT01863810|Drug|Placebo of KW21052|Oral,once a day, for 8 weeks
16139332|NCT01863810|Drug|Placebo of Lyrica|Oral, twice a day, for 8 weeks.
16139333|NCT01863797|Other|Early induction|
16139334|NCT01863797|Other|Expectant mamagement|
16139335|NCT01863784|Drug|JNJ-38518168|All participants will receive JNJ-38518168 30 mg tablet once daily from Day 1 to Day 14.
16139336|NCT01863771|Drug|Golimumab|Participants will receive 200 mg golimumab at Week 0 and 100 mg golimumab at Week 2 as a subcutaneous (SC) (under the skin) injection in the induction phase. Participants who have a clinical response in the induction phase and are randomly allocated to golimumab in the maintenance phase will receive 100 mg SC every 4 weeks through Week 52. Participants who do not have a clinical response in the induction phase will receive 100 mg of golimumab SC at Week 4 and will continue with 100 mg of golimumab SC every 4 weeks through Week 52 only if a response is obtained by Week 8.
16139337|NCT01863771|Other|Placebo|Participants who have a clinical response to golimumab in the induction phase and are randomly allocated to placebo in the maintenance phase will receive SC placebo every 4 weeks through Week 52. However, participants receiving placebo and who will lose clinical response any time during the study will be eligible to receive 100 mg golimumab SC every 4 weeks through Week 52.
16139338|NCT01863758|Biological|Human-cl rhFVIII|Human-cl rhFVIII was provided as a freeze-dried concentrate to be reconstituted in water for injection.
16139339|NCT01863745|Drug|nilotinib|Nilotinib can be provided as 200 mg and 150 mg hard gelatin capsules. The starting dose of nilotinib should be the same as the last dose that was given in the parent nilotinib study. After this, the dose of nilotinib is based on the investigator's judgment.
16139340|NCT01863732|Biological|Secukinumab|Group 1: secukinumab 75 mg plus placebo 150 mg or Group 2 secukinumab 150 mg plus placebo 75m dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only secukinumab 75 mg or 150 mg were dosed. Secukinumab in PFS for s.c. self-administration Q4W
16139341|NCT01863732|Other|Placebo (Pbo)|Group 1: secukinumab 75 mg plus placebo 150 mg or Group 2 secukinumab 150 mg plus placebo 75m dosed every four weeks Week 104E1 through Week 152. Starting on Week 156 (after unblinding), only secukinumab 75 mg or 150 mg were dosed. Secukinumab in PFS for s.c. self-administration Q4W
16139342|NCT01863719|Drug|Colistimethate sodium|Aerosol: In Dosing period 2 subjects receive 75mg colistin base activity via aerosol every 6 hours x 4 doses, followed by a washout period of at least 3 days. In Dosing period 3 subjects receive 75mg colistin base activity via aerosol every 6 hours x 4 doses in combination with 3.3mg/kg colistin base activity IV every 8 hours x 3 doses.
16139396|NCT01863381|Device|DPOAE|DPOAE measurement uses a clinical acoustic probe to record the ear's response to two simultaneous tones. DPOAE measurements will be made for 13 tones. The total measurement time for each condition is 2-4 minutes.
16139959|NCT01858948|Drug|Placebo|Similar in shape and color to Omega supplements
16139343|NCT01863719|Drug|Colistimethate sodium|Intravenous: In Dosing period 1 subjects receive 3.3mg/kg colistin base activity every 8 hours x 3 doses (total exposure 10mg/kg) intravenously (IV) followed by a washout period of at least 3 days. In Dosing period 3 subjects receive 3.3mg/kg colistin base activity IV every 8 hours x 3 doses in combination with 75mg colistin base activity via aerosol every 6 hours x 4 doses.
16139344|NCT01863706|Drug|Misoprostol|400µg oral misoprostol
16139345|NCT01863706|Drug|Oxytocin|20 IU Oxytocin
16139346|NCT01863680|Drug|COL-1620|The subjects will be administered with COL-1620 vaginal progesterone gel (1.125 grams of progesterone gel containing 90 milligram that is 8 percent [%] gel) vaginally once daily, from the day of ovum pick-up (OPU) until Week 12.
16139347|NCT01863680|Drug|Gonadotropin-releasing hormone (GnRH) analogue|Subjects will undergo conventional controlled ovarian stimulation (COS) therapy for in-vitro Fertilization and Embryo Transfer (IVF/ET) according to the Investigator's discretion using GnRH analogue (agonist or antagonist) preparation.
16139348|NCT01863680|Drug|Follicle-stimulating hormone (FSH)|Subjects will undergo conventional COS therapy for IVF/ET according to the Investigator's discretion using FSH containing preparation.
16139349|NCT01863680|Drug|Human Chorionic Gonadotropin (hCG)|Subjects will undergo conventional COS therapy for IVF/ET according to the Investigator's discretion using hCG preparation.
16139350|NCT01863667|Drug|Omarigliptin|Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly
16139351|NCT01863667|Drug|Glimepiride|Glimepiride tablet 1 mg and/or 2 mg (uptitrated to a maximum dose 6 mg/day) administered orally once daily with breakfast or the first main meal
16139352|NCT01863667|Drug|Omarigliptin Placebo|Matching placebo to omarigliptin capsule administered orally once weekly
16139353|NCT01863667|Drug|Glimepiride Placebo|Matching placebo to glimepiride tablet administered orally once daily with breakfast or the first main meal
16139354|NCT01863654|Drug|Montelukast 5 mg chewable tablets|Reference product
16139355|NCT01863654|Drug|Montelukast 5 mg chewable tablets|Test product
16139356|NCT01863641|Drug|calcitriol|Patients will receive calcitriol at a fixed dose of 0.25 µg (one oral pearl) daily.
16139357|NCT01863641|Drug|placebo|Patients will receive placebo similar to intervention (shape, color and design) 1 oral unit daily.
16139358|NCT01863628|Other|aerobic exercise|
16139359|NCT01863628|Other|psychoeducation|
16139360|NCT01863615|Drug|Isotretinoin 40 mg|Roaccutan 2 capsules of 20 mg; reference drug
16139361|NCT01863615|Drug|Isotretinoin 40 mg|Oratane 2 capsules of 20 mg; test drug
16139362|NCT01863602|Drug|Lamotrigine tablets|Administered for long-term according to the prescribing information in the locally approved label by the authorities.
16139363|NCT01863589|Drug|Adefovir tablets|Administered according to the prescribing information in the locally approved label by the authorities.
16139364|NCT01863576|Dietary Supplement|Omega-3|The group omega-3 receives 5 capsules / day, each capsule containing 1100mg of lipids, and 600 mg of omega-3, 3g of omega-3 per day (1.8 g EPA and 1.2 g DHA) for a period of 8 weeks.
16139365|NCT01863576|Dietary Supplement|Placebo Comparator|The group placebo receives 5 capsules / day of corn oil containing 1100mg each, for a period of 8 weeks.
16139366|NCT01863563|Device|QuickClot|1 application of treatment to each tonsil/adenoid removal area
16139367|NCT01863550|Drug|Bortezomib|Given SC or IV
16139368|NCT01863550|Drug|Carfilzomib|Given IV
16139369|NCT01863550|Drug|Dexamethasone|Given PO
16139370|NCT01863550|Other|Laboratory Biomarker Analysis|Optional correlative studies
16139371|NCT01863550|Drug|Lenalidomide|Given PO
16139372|NCT01863550|Other|Quality-of-Life Assessment|Ancillary studies
16139373|NCT01863537|Behavioral|Multimedia Connect|
16139374|NCT01863537|Behavioral|Traditional Connect|
16139375|NCT01863511|Drug|loop diuretic|
16139376|NCT01863511|Drug|tolvaptan|
16139377|NCT01863511|Procedure|ultrafiltration|
16139378|NCT01863498|Other|Epidural|Patients will have an epidural for pain control
16139379|NCT01863498|Other|PCA|Patients will have PCA for pain control
16139380|NCT01863485|Drug|CM082 Tablet|CM082 tablets taken orally once a day on 28-day cycles
16139381|NCT01863472|Device|HeartLight(TM) Laser Balloon|With the HeartLight(TM) Laser Balloon pulmonary vein isolation is done endoscopically guided
16139382|NCT01863472|Device|irrigated radiofrequency current ablation|The irrigated radiofrequency current ablation is used for pulmonary vein isolation
16139383|NCT01863459|Drug|Lisdexamfetamine Dimesylate|
16139384|NCT01863459|Drug|placebo|
16139385|NCT01863446|Device|Lighting1|Ocular light exposure to a red wavelength light for one or two nights
16139386|NCT01863446|Device|Lighting2|Ocular light exposure to a blue/green wavelength light for one night
16139387|NCT01863446|Device|Lighting3|Ocular light exposure to a red wavelength light (Device 1) on night 1 and to a blue/green wavelength light (Device 2) on night 2
16139388|NCT01863446|Device|Lighting4|Ocular light exposure to a red wavelength light (Device 1) on day 1 and to a blue/green wavelength light (Device 2) on day2
16139389|NCT01863433|Biological|Trivalent Influenza Vaccine|
16139390|NCT01863420|Radiation|Bone Marrow-sparing Intensity-Modulated Radiotherapy|Use Bone Marrow-sparing Intensity-Modulated Radiotherapy to limit the dose of active bone marrow in radiation fields. The BM regions on the T1-weighted images that showed a signal intensity equal to or slightly higher than that of muscle were contoured as active BM
16139391|NCT01863407|Drug|DAM|composed of dexamethasone, allantoin and metronidazole
16139392|NCT01863407|Drug|Normal Saline|Normal Saline 250ml
16139393|NCT01863394|Other|Screening by mothers|
16139394|NCT01863394|Other|Active comparator: Screening by community health workers|
16139395|NCT01863381|Device|Tympanic membrane displacement (TMD)|"The CCFP Analyser has a passive mode and an active mode. When used in active mode, the device generates a tone burst that is transmitted to the ear to elicit contraction of the stapedius muscle. The passive mode requires no stimulus or sound burst.
~For the lying, sitting, standing, and 10-degree head-down tilt conditions, the active mode will be used. Each condition comprises 13 stimuli of 0.3s duration.
~Overnight recording of non-invasive ICP will be done using the passive mode of the CCFP device."
16139487|NCT01862614|Drug|Buffered Articaine Hydrochloride + Epinephrine|
16139397|NCT01863368|Other|Preservative-free saline solution eyedrops|1 drop in each eye, 4 times a day, for up to two weeks as washout prior to Phase I and Phase II.
16139398|NCT01863368|Other|Systane® ULTRA lubricant eyedrops|
16139399|NCT01863368|Other|OPTIVE® lubricating eyedrops|
16139400|NCT01863355|Drug|B0 group: bolus 0.6mcg/kg without background infusion|
16139401|NCT01863355|Drug|BL group: bolus 0.4mcg/kg with background infusion rate 0.2mcg/kg/hr|
16139402|NCT01863355|Drug|BH group: bolus 0.2mcg/kg with background infusion rate 0.4mcg/kg/hr|
16139403|NCT01863342|Procedure|CSI score < 40|
16139404|NCT01863342|Procedure|CSI score ≥ 40|
16139405|NCT01863329|Procedure|retrobulbar ultrasound|both optic nerve sheath diameter (the posterior 3mm of the papilla), 5 individual measurement
16139406|NCT01863316|Device|I gel|
16139407|NCT01863316|Device|LMA Supreme|
16139408|NCT01863290|Other|Primary care redesign|Connect individuals released from prison to primary care using trained, culturally competent primary care providers and community health workers (CHWs).
16139409|NCT01863277|Drug|Melatonin|
16139410|NCT01863277|Drug|placebo|
16139411|NCT01863264|Other|Cold Thin Liquid Barium|Cold thin liquid barium will be fed to the participant from a standard bottle (60ml Similac® Volu-Feeder® with an attached Similac® Infant Nipple and Ring (standard flow)). For this study the refrigerated (cold) thin liquid barium will be measured for an exact temperature of 4-9°C prior to administration to control for any temperature variation. A total of 5 swallows will be visualized and saved electronically on the hospital's electronic storage system.
16139412|NCT01863251|Drug|Atomoxetine|
16139413|NCT01863238|Other|Ophthalmologic examinations|Subjects will undergo an ophthalmologic examination at study entry (Day 1) and every 6 months thereafter for 2 years (Months 6, 12, 18, and 24). Subjects who discontinue treatment with commercially-available ivacaftor for any reason and are willing to continue participation in the study will complete the study.
16139414|NCT01863238|Drug|Ivacaftor Exposed|
16139415|NCT01863225|Drug|RVX000222|capsule, 200 mg, administer with food, 100 mg twice daily 10-12 hrs apart, 14-days
16139416|NCT01863225|Drug|Rosuvastatin|20 mg daily, 28-42 days
16139417|NCT01863225|Drug|Atorvastatin|40 mg daily, 28-42 days
16139418|NCT01863225|Drug|Rosuvastatin|40 mg daily, 28-42 days
16139419|NCT01863225|Drug|Atorvastatin|80 mg daily, 28-42 days
16139420|NCT01863212|Procedure|Blood sampling for genetic analyse|Blood sampling are performed at the initiation visit in order to screen for allele variants
16139421|NCT01863212|Behavioral|Stroop test|Selective attention test where subjects, in one minute, names the ink color of several words without naming the word itself.
16139422|NCT01863212|Other|fMRI|Functional Magnetic Resonance Imaging, performed to view brain activity
16139423|NCT01863199|Drug|Lucentis (Treat and extend)|Lucentis 0.5mg will be administered on an as needed basis after a loading dose using a treatment extending protocol and home monitoring.
16139424|NCT01863199|Drug|Lucentis every 4 weeks|Lucentis 0.5mg administered intravitreally every four weeks for 12 months
16139425|NCT01863199|Drug|Lucentis every 12 weeks|Lucentis 0.5mg administered intravitreally every twelve weeks for 12 months
16139426|NCT01863186|Drug|Lofexidine HCl|Lofexidine HCl tablets will be available in 0.2 mg tablets. Lofexidine will be provided in total daily doses as indicated during the double blind portion of the study.
16139427|NCT01863186|Drug|Placebo|Lofexidine-matching tablets without the active pharmaceutical ingredient will be provided as 4 tablets QID during the double-blind portion of the study to subjects randomized to placebo.
16139428|NCT01863186|Drug|Open Label Lofexidine HCL|Lofexidine HCl tablets will are available in 0.2 mg tablets. During the optional open-label portion of the study, Lofexidine HCl can be prescribed at the discretion of the Investigator but total daily dose will not exceed 3.2 mg.
16139429|NCT01863173|Drug|metoprolol|using B blocker in patient group
16139430|NCT01863173|Drug|placebo|placebo to control group
16139431|NCT01863160|Drug|0.1% ZEP-3 cream|"Topical application of 250mg ZEP-3 cream (0.1%) vs. placebo 4 times daily The IP is applied to in advanced demarcated sites in a dose escalating mode to 3 different treatment area sizes: small area of 2x1 cm (2 cm2), medium area of 2x5 cm (10 cm2), and large area of 4x5 cm (20 cm2).
~The IP ZEP-3 cream will be applied on both ventral forearms (one application site per forearm) in a non-occlusive mode, spread and rubbed over the demarcated area.
~Right arm, single treatment area - ZEP-3 (0.1%)
~Left arm, single treatment area - Placebo cream"
16139432|NCT01863160|Drug|placebo|"Topical application of 250mg ZEP-3 cream (1.0%) vs. placebo 4 times daily The IP is applied to in advanced demarcated sites in a dose escalating mode to 3 different treatment area sizes: small area of 2x1 cm (2 cm2), medium area of 2x5 cm (10 cm2), and large area of 4x5 cm (20 cm2).
~The IP ZEP-3 cream will be applied on both ventral forearms (one application site per forearm) in a non-occlusive mode, spread and rubbed over the demarcated area.
~Right arm, single treatment area - ZEP-3 (1.0%)
~Left arm, single treatment area - Placebo cream"
16139433|NCT01863147|Drug|Sitagliptin and acarbose|Sitagliptin group: The intervention drug is sitagliptin. Acarbose group: The intervention drug is acarbose.
16139434|NCT01863134|Drug|Eptifibatide|
16139435|NCT01863134|Drug|Placebo|
16139436|NCT01863108|Biological|GeniusVac-Mel4|Multiple sub-cutaneous injections (1 injection weekly during 3 weeks) of GeniusVac-Mel4 (3 increasing dose groups) in patients with melanoma
16139437|NCT01863095|Behavioral|Personalized Feedback and Exercise|
16139438|NCT01863082|Other|exercise|practice of physical exercise
16139439|NCT01863069|Drug|Interferon beta 1a|
16139440|NCT01863069|Drug|(IM) AVONEX®|
16139441|NCT01863056|Other|Sit-Stand Desk|Subjects were asked to participate in the study for a total period of three months. Based on randomization, either the first or third month involved the active intervention to use an adjustable sit-stand desk. The other two months required the subjects to follow their usual work routine without the adjustable sit-stand desk. The control period month involved all the same measurements as the active intervention month, whereas the washout period, which was the 2nd (middle) month, did not involve any measurement and there was no contact with the subjects during the washout month.
16139442|NCT01863043|Procedure|No aspiration of gastric contents|Infants will not have routine aspiration of gastric contents prior to every feeding to assess residual gastric contents.
16139443|NCT01863043|Procedure|Routine aspiration of gastric contents|Infants will have routine aspiration of gastric contents prior to each feeding to monitor the amount of residual gastric contents remaining in the stomach.
16139444|NCT01863030|Device|Phasix mesh implant|
16139445|NCT01863017|Device|tDCS|
16139446|NCT01863004|Drug|Bortezomib|
16139447|NCT01862991|Other|Hygroscopic cervical dilators|Dilapan-S osmotic cervical dilators inserted through the internal os.
16139448|NCT01862991|Drug|Misoprostol|400 mcg buccal misoprostol 90 pre-op
16139449|NCT01862991|Drug|Intra-amniotic digoxin|1mg digoxin administered intra-amniotically ~24 hours pre-op in patients that are greater than 22 weeks gestation
16139450|NCT01862991|Drug|Mifepristone|200 mcg Mifepristone orally
16139451|NCT01862978|Drug|Heparin|
16139452|NCT01862978|Drug|Nadroparin|
16139453|NCT01862978|Drug|Placebo|
16139454|NCT01862965|Drug|PredEver|Firstline treatment with prednisone and Everolimus
16139455|NCT01862952|Other|starting of anti-epileptic drug treatment|
16139456|NCT01862939|Drug|DS-7309|1, 2.5, 5, 10, 20 mg DS-7309 powder in bottle.
16139457|NCT01862939|Drug|placebo|placebo to match part 2 DS-7309
16139458|NCT01862926|Drug|Rituximab|
16139459|NCT01862926|Drug|Cyclophosphamide|
16139460|NCT01862913|Other|Computer-assisted cognitive-behavioral therapy|The intervention arm will receive eight sessions of computer-assisted CBT plus usual medical treatment, as described in the AUGE Clinical Guidelines for Depression. Computer-assisted CBT sessions will be delivered on a weekly basis and assisted by trained psychologists in face-to-face meetings. The program is called 'Yo pienso, siento y actúo mejor' (YPSA-M); in English, 'I think, feel, and behave better'. Topics covered in the program will include information on symptoms and causes of depression, treatment options, problem-solving techniques and other cognitive-orientated strategies to challenge negative thoughts.
16139461|NCT01862913|Other|Usual care treatment|The control arm will receive treatment as usual from the primary care clinics. The professionals in the primary care centers will be instructed to follow the AUGE Clinical Guidelines for Depression.
16139462|NCT01862900|Biological|MEDI6469|Patients receive 3 doses of MEDI6469; one on Days 1, 3, and 5
16139463|NCT01862887|Drug|PH-797804|Tablet, 24 mg, single dose
16139464|NCT01862887|Drug|Moxifloxacin|Tablet, 400 mg, single dose
16139465|NCT01862887|Drug|Placebo|Tablet, PH-797804 matched placebo, single dose
16139466|NCT01862874|Biological|V501|Formulated with aluminum hydroxyphosphate sulfate (AAHS) adjuvant
16139467|NCT01862874|Biological|Placebo|Formulated with AAHS adjuvant
16139468|NCT01862835|Drug|Degarelix|
16139469|NCT01862835|Drug|Testosterone|
16139470|NCT01862835|Drug|Anastrozole|
16139471|NCT01862835|Drug|Estrogen patch|
16139472|NCT01862822|Other|upright position|
16139473|NCT01862796|Behavioral|Underfeeding diet|Heart healthy diet with 35% reduced calories
16139474|NCT01862796|Behavioral|Weight maintaining diet|Heart healthy weight-maintaining diet
16139475|NCT01862718|Procedure|Thermal Ablation|On Thursday in the first week, subject will receive the radiofrequency ablation.
16139476|NCT01862718|Procedure|Standard External Beam Radiation Therapy|During those 2 weeks, subject will receive radiation on Monday, Wednesday and Friday.
16139477|NCT01862705|Other|Thoracic spine manipulation|TSM thrust or non-thrust
16139478|NCT01862692|Behavioral|Baby-Net|Parents randomized to the intervention condition will receive a computerized adaptation of the empirically supported PALS parenting program as well as a laptop and wireless Internet connection. In this study, we adapted original 10-session PALS program for computer administration and included a session on reading (Read to Me, Inc.; http://www.readtomeprogram.org/index.html), developed to be incorporated within the PALS program. Each session includes the following: (a) a presentation of concepts, behaviors, and examples, (b) check-in questions recorded to the data base for review by both parent and coach, (c) the creation of a 5 minute computer-collected video of mother-infant interactions for later review by coach and parent, (d) a summary of topics, (e) daily activities (homework), (f) feedback about the program recorded to the database and (g) a weekly telephone coach call to review mother-infant computer-administered video and session topics and skills.
16139479|NCT01862692|Behavioral|Developmental Awareness Skills|Mothers in this condition will receive weekly phone contact with a coach as well as a laptop and wireless Internet connection. The laptop will contain a computer-based infant intervention program that is structurally similar to the Infant Program in terms of components (e.g., information pages, mother-infant video recording pages; coach contact pages), however weekly information will focus on their infants' development, with no direct maternal skills instruction. Mothers in this condition will receive the same number of contacts with the computer and coach as mothers in the InfantNet condition and will participate in weekly phone calls with a coach. During phone calls, parents will co-view weekly mother-infant video with their coach, with mothers having been instructed to play with their infant (with no prescribed tasks to perform) and the discussion will focus on general infant development.
16139480|NCT01862679|Other|High-flux haemodialysis|High-flux haemodialysis is the standard dialysis modality currently in use in the UK
16139481|NCT01862679|Procedure|Haemodiafiltration|"During Haemodiafiltration, the dialysis machine removes more water from the blood than during normal hemodialysis. The additional liquid is continually replaced with an ultra-pure solution. Thus, the machine exchanges a high volume of fluid during treatment and removes the liquid together with toxins from the blood."
16139482|NCT01862653|Device|Auricular Acupuncture|Subjects receiving the auricular acupuncture intervention will be treated in a quiet private room sitting in a comfortable chair. The external ear cartilage of both ears will be cleaned with isopropyl alcohol swabs. A clean insertion technique will be used with stainless steel SEIRIN D type acupuncture needles (0.20mm diameter, 15mm length) on each of the identified acupuncture points (Shen men, Point zero, brain, thalamus, Pineal, Master cerebral, Insomnia 1, Kidney, Heart, Insomnia 2, Occiput, Forehead) to bilateral ears for a total of 30 minutes. Acupuncture will be administered by a board certified Psychiatrist with supplemental privileges to perform acupuncture.
16139483|NCT01862640|Drug|Brexpiprazole, OPC-34712|Once-daily, tablets
16139484|NCT01862640|Drug|Placebo Oral Tablet|Once-daily, tablets
16139485|NCT01862627|Procedure|Optical coherence tomography|
16139486|NCT01862614|Drug|Articaine Hydrochloride + Epinephrine|
16139488|NCT01862601|Device|JetTouch Needle-free injection system|Needle-free injection system believed to provide consistent and reliable delivery of material to the bladder wall.
16139489|NCT01862562|Procedure|Open surgery|Conventional technique
16139490|NCT01862562|Procedure|Laparoscopic surgery|New minimum invasive technique
16139491|NCT01862549|Behavioral|Dialectical Behavior Therapy for children|
16139492|NCT01862549|Behavioral|Treatment as Usual|
16139493|NCT01862536|Drug|Tadalafil|Daily use of study drug to treat pulmonary hypertension.
16139494|NCT01862536|Drug|placebo|Daily use in double blind study.
16139495|NCT01862523|Biological|Capsaicin|Thirty-three* well-characterized IR patients will be recruited and screened for participation in this study with nasal capsaicin spray (0,1 mmol/l ) using the treatment regimen described by van Rijswijk et al. (1 x 5 applications in one day, with 1 hour between each application)
16139496|NCT01862523|Biological|diluent|diluent
16139497|NCT01862497|Drug|Carvedilol vs. Prazosin|
16139498|NCT01862484|Dietary Supplement|Restricted Diet|Child is on an additive, gluten free diet. Child receives daily snacks which conform to the restrictive diet.
16139499|NCT01862484|Dietary Supplement|Ruse Diet|Child is on an additive, gluten free diet. Child receives daily snacks which violate the restrictive diet
16139500|NCT01862471|Device|Neuromuscular Electrical Stimulation|Frequency of 36Hz, a balanced biphasic waveform with a pulse width of 350μs, a ramp up time of 500ms, a contraction time of 1s and a ramp down time of 500ms.
16139501|NCT01862471|Device|Intermittent Pneumatic Compression|Programmed to deliver compression every 20 seconds at a pressure of 130mmHg for a 1 second duration over a period of 5 minutes.
16139502|NCT01862458|Biological|tPA alone|
16139503|NCT01862458|Biological|tPA plus dornase|
16139504|NCT01862432|Other|Immediate skin-to-skin|The newborn is place on his mother's chest, immediately (in the first minute of life), in order to allow complete skin-to-skin contact.
16139505|NCT01862419|Other|Alert|
16139506|NCT01862406|Other|Label|Participants were presented with either a generic label or a brand-name label
16139507|NCT01862393|Device|400 microseconds|Neuromuscular electrical stimulation with stimulus phase duration of 400 microseconds
16139508|NCT01862393|Device|700 microseconds|Neuromuscular electrical stimulation with stimulus phase duration of 700 microseconds
16139509|NCT01862393|Device|1000 microseconds|Neuromuscular electrical stimulation with stimulus phase duration of 1000 microseconds
16139510|NCT01862380|Other|Functional explorations|Functional explorations of cortisol and aldosterone production during stimulation by ITT and sodium depletion respectively
16139511|NCT01862380|Other|Functional explorations|Functional explorations of cortisol and aldosterone production during stimulation by ITT and sodium depletion respectively
16139512|NCT01862367|Drug|catridecacog|No treatment given. All patients enrolled in this observational study will receive their medication through usual commercial channels.
16139513|NCT01862354|Procedure|Transverse abdominal plan block|Transverse abdominal plan block was performed after induction of anaesthesia and before surgery. 3 mg/kg of Ropivacaine 5mg/ml (maximum 200 mg) plus 150 microg of Clonidine were injected at the good place. The was realised with the aid of ultrasound
16139514|NCT01862354|Procedure|Continuous wound infusion|In this group, a multihole catheter was surgically inserted vertically before skin closure. The catheter was primed with Ropivacaine 2 mg/ml 10 ml plus clonidine 150 microg before the end of anaesthesia. Continuous wound infusion was started at a rate of 10 ml per hour of Ropivacaine 2 mg/ml during the first 9 hours after the surgery.
16139515|NCT01862341|Dietary Supplement|ANMUM In-Shape Nutritional Milk Powder for Active Mothers|
16139516|NCT01862328|Drug|MLN4924|"MLN4924 (intravenously [IV]) in participants in a 21-day cycle:
~MLN4924 on Days 1,3,5 of each cycle"
16139517|NCT01862328|Drug|Paclitaxel|"Paclitaxel (IV) in a 21-day cycle:
~Paclitaxel on Day 1 of each cycle"
16139518|NCT01862328|Drug|Gemcitabine|"Gemcitabine (IV) in participants in a 28-day cycle:
~-Gemcitabine on Days 1,8,15 of each cycle"
16139519|NCT01862328|Drug|Docetaxel|"Docetaxel (IV) in participants in a 21-day cycle:
~- Docetaxel on Day 1 of each cycle"
16139520|NCT01862328|Drug|Carboplatin|"Carboplatin (IV) in participants in a 21-day cycle:
~- Carboplatin on Day 1 of each cycle"
16139521|NCT01862315|Drug|Floxuridine (FUDR)|
16139522|NCT01862315|Drug|dexamethasone|
16139523|NCT01862315|Drug|Gemcitabine|
16139524|NCT01862315|Drug|Oxaliplatin|
16139525|NCT01862315|Other|MRI|
16139526|NCT01862315|Other|Research blood draws|These are optional
16139527|NCT01862302|Drug|Haloperidol|1mg the night before and 1mg the morning of surgery; OR Haloperidol 2mg the morning of surgery
16139528|NCT01862302|Drug|Placebo|1 dose the night before and 1 dose the morning of surgery; OR 2 doses the morning of surgery
16139529|NCT01862289|Other|Diagnostic of chronic hyperventilation syndrome|Nijmegen questionnaire, Hyperventilation challenge and blood gases
16139530|NCT01862263|Drug|Vildagliptin|Orally active and highly selective inhibitor of DPP-4
16139531|NCT01862263|Drug|Insulin|Long- acting human insulin analog indicated to improve glycemic control
16139532|NCT01862263|Drug|Placebo|Matching placebo of vildagliptin
16139533|NCT01862250|Drug|Clonidine (Duraclon®)|"Clonidine at dosing intervals of 6, 8, 12, 18 or 24 hours. If the following is observed the event will be recorded, and no additional clonidine will be given and blood will be drawn to measure plasma level of clondine.
~10 mm Hg reduction in MAP or MAP ≤ 40 mm Hg sustained for ≥30 min after administration
~20% drop in HR from the infant's baseline, sustained for ≥30 min after administration
~HR ≤70/min, sustained for ≥30 min after administration"
16139534|NCT01862237|Other|Intervention|"blood collection
~Completion of a pre-operative cardiac MRI.
~Completion of a coronary angiography examination
~Completion during the surgery d'une myocardial biopsy,
~Aortic echocardiographic follow-up (including post-operative ultrasound and ultrasound at 1 year
~Completion of a cardiac MRI 1 year after surgery."
16139535|NCT01862224|Drug|JNJ-38518168|JNJ-38518168 30 mg once daily, Week 0 to Week 52.
16139536|NCT01862224|Drug|Placebo|Matching placebo once daily (Week 0 to Week 12).
16139537|NCT01862224|Drug|Methotrexate|All participants will continue receiving methotrexate up to Week 12. After Week 12, the dose of methotrexate may be adjusted as per Investigator's discretion.
16139578|NCT01861873|Other|measuring liver function by 18-FDGal PET/CT|
16139538|NCT01862211|Other|blood sampling|A blood sampling will be performed for the genetic analysis and the measurement of serum IL-8.
16139539|NCT01862198|Device|EUS-guided biliary drainage with a hybrid metallic stent|EUS-guided biliary drainage with a newly designed hybrid metallic stent
16139540|NCT01862185|Other|semi-quantitative procalcitonin|
16139541|NCT01862172|Other|Additional MRI|
16139542|NCT01862159|Procedure|laparoscopic gastric bypass surgery|laparoscopic gastric bypass surgery
16139543|NCT01862146|Procedure|smoke expose|
16139544|NCT01862133|Other|Patient preferences|Software for recording patients' preferences for which providers see which parts of their EMRs, and EMR software for restricting access to data based on patients' preferences.
16139545|NCT01862120|Drug|Dose D1 of interleukin-2|subcutaneous injection of Interleukin-2 during 5 days, once daily repeated administration(Induction period). At day 15 single administration of Interleukin-2 every two weeks during one year (maintenance period).
16139546|NCT01862120|Drug|placebo|subcutaneous injection of Interleukin-2 during 5 days, once daily repeated administration(Induction period). At day 15 single administration of Interleukin-2 every two weeks during one year (maintenance period).
16139547|NCT01862120|Drug|Dose D2 of Interleukin-2|subcutaneous injection of Interleukin-2 during 5 days, once daily repeated administration(Induction period). At day 15 single administration of Interleukin-2 every two weeks during one year (maintenance period).
16139548|NCT01862120|Drug|Dose D3 of interleukin-2|subcutaneous injection of Interleukin-2 during 5 days, once daily repeated administration(Induction period). At day 15 single administration of Interleukin-2 every two weeks during one year (maintenance period).
16139549|NCT01862081|Drug|Docetaxel|Participants will receive docetaxel 75 milligrams per meter-squared (mg/m^2) intravenous (IV) dose on Day 1 of each 21-day cycle.
16139550|NCT01862081|Drug|GDC-0032|Participants will receive escalated dose of GDC-0032. The initial dose will be 3 mg capsules or 2 mg tablets.
16139551|NCT01862081|Drug|Paclitaxel|Participants will receive paclitaxel 80 mg/m^2 IV dose on Day 1, 8, 15 and 22 of each 28-day cycle.
16139552|NCT01862068|Other|Blood samples and clinical data|Blood samples will be performed at inclusion and at 12 months from all patients (4 groups GPA, MPA, EGPA and Atherosclerotic patients)
16139553|NCT01862068|Other|Blood sample|Blood sample will be performed at inclusion from all healthy patients
16139554|NCT01862042|Other|Follow-up diary and questionnaire|A follow-up diary will be completed by the families and the different practitioners working with the patient. One year after the death of the patient, a questionnaire will be proposed to the parents of the child by a psychologist.
16139555|NCT01862029|Drug|Roflumilast|Selective phosphodiesterase 4 (PDE4) inhibitor
16139556|NCT01862016|Procedure|APRV|Pressure ventilation mode allowing early spontaneous breathing
16139557|NCT01862016|Biological|arterial blood gas measurement each morning|
16139558|NCT01862003|Drug|AZD8931|160 mg AZD8931 tablets, twice daily on days 1 - 4 of each 2-weekly cycle
16139559|NCT01862003|Drug|Irinotecan|180 mg/m2 (IV infusion) of Irinotecan on day 1 of each 2-weekly cycle - can be given simultaneously with Folinic acid.
16139560|NCT01862003|Drug|Folinic Acid|350 mg (IV infusion) of Folinic acid on day 1 of each 2-weekly cycle - can be given simultaneously with Irinotecan.
16139561|NCT01862003|Drug|Fluorouracil|400 mg/m2 (IV bolus) of Fluorouracil on day 1 of each 2-weekly cycle, to be given after completion of Irinotecan and Folinic acid.
16139562|NCT01862003|Drug|Fluorouracil|2400 mg/m2 (IV) continuous infusion of Fluorouracil given over 46 hours - infusion to start after 5FU bolus.
16139563|NCT01861990|Drug|Valproic Acid|All participants enrolled on valproic acid arm.
16139564|NCT01861977|Behavioral|Cognitive Behavioral Therapy|Participants in this arm will be invited to attend 8 weekly group meetings and 3 monthly follow-up meetings. In each meeting a coordinator will explore the experiences of the participants and encourage them to look for strategies to solve problems associated with changing habits. In the meetings we will use a therapeutic education approach with motivational interviewing techniques and problem solving in order to increase self-efficacy and motivation to adopt healthy habits. There will be periodic reminders and telephone contacts with patients before the meetings to assess the achievement of objectives.
16139565|NCT01861977|Behavioral|Informational Workshop|Participants will be invited to participate in 4 weekly group meetings and an additional reinforcing meeting in the 5th month. In each meeting, workshop techniques will be used, together with educational materials as brochures, pictures, etc. The informational material will focus on the benefits of lifestyle changes in diet and physical activity.
16139566|NCT01861964|Dietary Supplement|Placebo (Maltodextrin)|Maltodextrin 505mg/capsule 8 capsules/day (4 with breakfast and 4 with dinner meal)
16139567|NCT01861964|Dietary Supplement|Xylooligosarcharide 1.4g|8 capsules (512 mg/capsule) 4 with breakfast and 4 with dinner meal
16139568|NCT01861964|Dietary Supplement|Xylooligosarcharide 2.8g|8 capsules (520 mg/capsule) to be taken in the morning and in the evening
16139569|NCT01861951|Drug|Pazopanib|
16139570|NCT01861951|Drug|Doxorubicin|
16139571|NCT01861938|Biological|Melanoma vaccine modified to express HLA A2/4-1BB ligand|
16139572|NCT01861912|Device|Arsenic trioxide TACE|Arsenic trioxide powder 20mg dissolved in lipiodol(the dosage of lipiodol is decided according to the volume of the target lesion)is used for transcatheter arterial chemoembolization(TACE). TACE will be repeated after 4~6 weeks if it is necessary according to the assessment from imaging modalities
16139573|NCT01861912|Drug|Arsenic trioxide intravenous infusion|Arsenic trioxide intravenous infusion: arsenic trioxide powder 0.15mg/Kg/d(maxim 10mg/d) dissolved in 250ml 0.9%NaCl solution is used for intravenous infusion.Every course will last for 3 weeks and the next course will be continued after 1 week suspension.Intravenous infusion will be suspended 3 days before and 7~14 days after TACE.
16139574|NCT01861912|Drug|lipiodol|Lipiodol is used to dissolve arsenic trioxide for TACE,with the dosage decided according to the volume of the target lesion.
16139575|NCT01861912|Drug|NaCl solution|250ml NaCl solution is used to dissolve the arsenic trioxide for intravenous infusion.
16139576|NCT01861899|Device|SI-LOK|Sacro-iliac joint fusion
16139577|NCT01861886|Device|ESS505 (BAY1454033)|Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 in the proximal portion of the fallopian tubes using a transvaginal approach. Subsequent transvaginal ultrasound (TVU) or hysterosalpingogram (HSG) was performed approximately ≤ 3 hours and 90 days following insert placement.
16139579|NCT01861860|Device|TAXUS™ Element long stent|Segments are selected using bifurcation branch take-off. The reference is selected or estimated on both sides of the bifurcation and is applied to the concerned segment. The objective is to attain > 80% of the reference cross-sectional areas (CSA) per segment. The balloon diameter is adapted to the endoluminal diameter of the reference.
16139580|NCT01861847|Drug|7-Keto Dehydroepiandrosterone|7-Keto Dehydroepiandrosterone, 100 mg capsules given orally twice daily for 4 weeks in one of the two intervention phases, dependent on randomization assignment.
16139581|NCT01861847|Drug|Placebo|Placebo, 100 mg capsules given orally twice daily for 4 weeks in one of the two intervention phases, dependent on randomization assignment.
16139582|NCT01861834|Drug|Omegaven 10%|"Patients with a sustained TPN requirement due to short bowel syndrome and TPN-associated liver disease that threatens progression to liver failure and death, for which the only available means of prevention at present is timely liver and/or intestinal transplant.
~Omegaven 10%, 1 gram/kg, IV, every 12 hours until transplantation, or stopping TPN"
16139583|NCT01861821|Device|Multiport flexible catheter|Multiport flexible catheter has three ports for the delivery of epidural medication
16139584|NCT01861821|Device|Uniport flexible catheter|Uniport flexible catheter has one port for the delivery of epidural medication
16139585|NCT01861808|Other|Lumbar puncture|The only intervention is the lumbar puncture on the patients to obtain a Cerebrospinal Fluid sample
16139586|NCT01861795|Other|Preterm Neonates|Preterm Neonates
16139587|NCT01861782|Other|Dead Sea Solar and Water Treatment|
16139588|NCT01861782|Other|Sulfur Pool & Medicinal Mud|
16139589|NCT01861769|Other|Technology-enhanced Teleconsultation|Technology-enhanced Group Tele-consultation. This consultation method requires that participants be prepared to review and receive feedback on audiorecorded CPT sessions in a group format. The CPT expert randomly selects two clinician sessions each week that have been audiorecorded to use for feedback and discussion in group teleconference based on procedures used in previous training initiatives (Stirman, Bhar, et al., 2010). Five- to twenty-minute segments of the two sessions will be shared within the group consultation. The CPT expert will provide feedback on the sessions with an emphasis on review of key learning points. These consultation group sessions will be facilitated with collaborative meeting software that includes audio file uploading.
16139590|NCT01861769|Other|Standard Teleconsultation|Standard Tele-consultation Group. The CPT expert will randomly select clinicians for case presentation each week. Each clinician will be responsible for verbally presenting on their CPT cases throughout the 6-month period of consultation course. No audiorecorded content will be reviewed within the calls. All other procedures used in the above condition will be used here.
16139591|NCT01861756|Other|Diabetes Medication Choice decision aid|The Diabetes Medication Choice decision aid cards provide information about medications commonly used to treat type 2 diabetes mellitus. The tool was originally developed and successfully evaluated by Mayo Clinic researchers.
16139592|NCT01861743|Other|Multimodal Analgesia|Subjects are given medications preop, intraop and postop that implement a multi-modal approach to managing pain.
16139593|NCT01861743|Other|Patient controlled analgesia|Subjects will be treated with patient controlled narcotic analgesia for pain management.
16139594|NCT01861730|Biological|AERAS-404|AERAS-404 has two components: the H4 antigen and the IC31 adjuvant. The reconstitution of the vaccine components, H4 antigen (manufactured at SP) and IC31 adjuvant (supplied by SSI), will take place at the clinical research site (CRS) prior to injection.
16139595|NCT01861730|Biological|Placebo|Tris buffered saline (10mM Tris, pH 7.4, 150nm sodium chloride).
16139596|NCT01861717|Drug|lanreotide|Somatuline Depot 90 mg deep subcutaneous injection every 4 weeks X 3 doses
16139597|NCT01861704|Device|Lyric|Extended wear hearing instrument
16139598|NCT01861704|Device|Lyric2|Extended wear hearing instrument
16139599|NCT01861691|Procedure|Open surgery|Conventional technique
16139600|NCT01861691|Procedure|Laparoscopic surgery|New minimum invasive technique
16139601|NCT01861678|Procedure|High tie of IMA|Conventional technique
16139602|NCT01861678|Procedure|Low tie of IMA|Technique for preserving left colic arterial perfusion
16139603|NCT01861665|Drug|Marcaine- 0.25%|Marcaine 0.25% administered pre-incision.
16139604|NCT01861665|Drug|Marcaine 0.25%.|Marcaine 0.25% administered post-incision.
16139605|NCT01861652|Device|Venous Health Systems Vasculaire Leg Compression Device|Leg (calf) compression device used to alleviate symptoms of restless legs
16139606|NCT01861639|Device|ineffective rTMS|A 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold. Active stimulation will be applied on the L-DLPFC compared to an ineffective stimulation.
16139607|NCT01861639|Device|active TBS|A continuous Theta-Burst Stimulation (cTBS) protocol will be applied over the L-DLPFC. Three stimuli at 50Hz, 80% of individual Motor Threshold will be repeated every 200ms for 40sec
16139608|NCT01861639|Device|Sham TBS|A Sham stimulation will be applied over the L-DLPFC. a placebo coil will be used.
16139609|NCT01861639|Device|fMRI|Functional MRI data will be acquired during the performance of the memory task. Functional data will be acquired with a blood oxygenation level dependant (BOLD) contrast sensitive gradient echo, T2*-weighted echo-planar imaging sequence
16139610|NCT01861639|Device|EEG|EEG will be coupled with task performance in an event-related manner to be able to isolate brain activity of each type of stimuli presented. EEG imaging data will be acquired during the memory task.
16139611|NCT01861639|Device|Effective rTMS|A 20Hz repetitive transcranial magnetic stimulation (rTMS) will be applied for 900 ms with an intensity of 90% of motor threshold. Active stimulation will be applied on the L-DLPFC compared to an effective stimulation.
16139612|NCT01861626|Drug|V0057 - A mg|Single oral administration
16139613|NCT01861626|Drug|Isotretinoin|Single oral administration
16139614|NCT01861613|Biological|HBV vaccine (Engerix-B, recombinant hepatitis B surface antigen, 20µg/mL/vial, GlaxoSmithKline, Belgium)|
16139615|NCT01861600|Other|S-26 Gold|(13.4 g/L protein) with 100% Fat Blend A
16139616|NCT01861600|Other|S-26 Gold EF1|(13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend
16139617|NCT01861600|Other|S-26 Gold EF2|(13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend, and supplemented with 3.0 g/L oligofructose
16139618|NCT01861600|Other|S-26 Gold EF3|(13.4 g/L protein) with 60% Fat Blend A and 40% Betapol fat blend, and supplemented with 5.0 g/L oligofructose
16139621|NCT01861574|Device|Real TMS 45 min|Real TMS 45 minutes after surgery, first determined resting motor threshold (rMT) by starting with 40% of the machine output and 0.5 Hz stimulus frequency. The coil was positioned over the motor cortex and then adjusted until each pulse results in movement of the right thumb. The machine output was then adjusted to the lowest intensity that reliably produces thumb movement. Parameter estimation by sequential testing was used to determine the amount of machine energy necessary to visibly move the thumb 50% of the time. rMT was assessed before each rTMS treatment. The left prefrontal cortex was the cortical target for rTMS treatment. The EEG-10-20 system was used to locate the prefrontal cortex (F3).
16139622|NCT01861574|Device|Sham TMS 45 min|Sham TMS 45 minutes after surgery used specifically designed rTMS coil that produces auditory signals identical to real (active) TMS coils but is shielded so that actual stimulation does not occur. The eSham system was used to mimic sensations of real rTMS. This system produces mild tingling on the scalp underneath the sham rTMS coil, making it difficult in differentiating between real and sham. The amount of electrical stimulation necessary to match real rTMS pulses was determined using an algorithm (parameter estimation by sequential testing). All subjects underwent the sham titration at the beginning of every rTMS session regardless of group assignment. The left prefrontal cortex was the cortical target for rTMS treatment, located using the EEG-10-20 system.
16139623|NCT01861574|Device|Real TMS 4 Hours|Real TMS 4 hours after surgery, first determined resting motor threshold (rMT) by starting with 40% of the machine output and 0.5 Hz stimulus frequency. The coil was positioned over the motor cortex and then adjusted until each pulse results in movement of the right thumb. The machine output was then adjusted to the lowest intensity that reliably produces thumb movement. Parameter estimation by sequential testing was used to determine the amount of machine energy necessary to visibly move the thumb 50% of the time. rMT was assessed before each rTMS treatment. The left prefrontal cortex was the cortical target for rTMS treatment. The EEG-10-20 system was used to locate the prefrontal cortex (F3).
16139624|NCT01861574|Device|Sham TMS 4 Hours|Sham TMS 4 hours after surgery used specifically designed rTMS coil that produces auditory signals identical to real (active) TMS coils but is shielded so that actual stimulation does not occur. The eSham system was used to mimic sensations of real rTMS. This system produces mild tingling on the scalp underneath the sham rTMS coil, making it difficult in differentiating between real and sham. The amount of electrical stimulation necessary to match real rTMS pulses was determined using an algorithm (parameter estimation by sequential testing). All subjects underwent the sham titration at the beginning of every rTMS session regardless of group assignment. The left prefrontal cortex was the cortical target for rTMS treatment, located using the EEG-10-20 system.
16139625|NCT01861561|Drug|Low-dose intravenous cyclophosphamide|Intravenous cyclophosphamide 500 mg/m2/dose every 4 weeks/months, total 7 doses
16139626|NCT01861561|Drug|High-dose intravenous cyclophosphamide|"Intravenous cyclophosphamide every 4 weeks/months, total in 7 doses:
~the 1st dose-500 mg/m2/dose,the 2nd dose-750 mg/m2/dose, the 3rd-7th doses- 1,000 mg/m2/dose with the maximum dose at 1,500 mg/dose"
16139627|NCT01861535|Drug|Imiquimod|
16139628|NCT01861535|Procedure|Surgery|
16139629|NCT01861522|Drug|Bepotastine besilate|Two TAU-284 5mg tablets will be taken orally twice a day
16139630|NCT01861522|Drug|Placebo|Two Placebo tablets will be taken orally twice a day
16139631|NCT01861509|Drug|BP-C1|BP-C1, 0.05% solution for injection; doses: 0.035 mg/kg body weight (0.07 mL/kg) intramuscularly once daily for 32 consecutive days
16139632|NCT01861496|Drug|LiPlaCis|LiPlaCis IV every 3 weeks on day 1, day 8
16139633|NCT01861457|Other|Nozin® Nasal Sanitizer®|The treatment agent tested was the alcohol and natural oil preparation that comprises the commercially available over-the-counter (OTC) product, NOZIN® Nasal Sanitizer® antiseptic, by Global Life Technologies Corp, with the addition of benzalkonium chloride (0.13%), as described for the patented and safety-tested formulation.
16139634|NCT01861457|Other|Placebo|The placebo preparation, utilized to account for the potential mechanical effects of the application process, was phosphate buffered saline (PBS).
16139635|NCT01861431|Behavioral|HIV Sexual Risk reduction|4 sessions of HIV sexual risk reduction
16139636|NCT01861431|Behavioral|HIV Sexual Risk reduction plus Microfinance|4 sessions of sexual risk reduction plus 12 sessions of financial literacy, 12 sessions of business development training, 10 sessions of business mentorship; matched savings throughout course of intervention
16139637|NCT01861418|Other|Lumbopelvic Manipulation|Participant will lie in supine position. The treating investigator (TI) will stand on opposite side of low back pain. Participant will clasp his/her hand behind the neck. TI will side bend participant's spine towards non-painful side. TI will reach through participant's hands and perform spinal rotation away from painful side. TI's other hand will be placed over anterior superior iliac spine (ASIS) of painful side. TI will take up the slack and maintain pressure on the ASIS for 5-10 seconds and ask the participant whether he/she can tolerate the pressure. If participant can tolerate the pressure for at least 5 seconds, verbal permission will be obtained from participant and TI will proceed and apply a high-velocity low-amplitude posterior thrust force over the ASIS.
16139638|NCT01861418|Other|Sham manipulation|Each participant will be asked to lie in a supine position. The treating investigator will stand on the opposite side of the low back pain. Then, the participant will be asked to clasp his/her hand behind the neck. The treating investigator will side bend the participant's spine towards the non-painful side to mid-range. The treating investigator will reach through the participant's hands and perform a spinal rotation away from the painful side to the mid-range. The treating investigator's other hand will be placed over the anterior superior iliac spine (ASIS) of the painful side.
16139639|NCT01861405|Behavioral|neuropsychological testing and quality of life assessments|
16139640|NCT01861405|Radiation|Standard of Care WBRT or SRS|
16139641|NCT01861405|Device|Functional magnetic resonance imaging|
16139642|NCT01861392|Procedure|sensorio-motor training|
16139643|NCT01861379|Procedure|Ghost Ileostomy|At the end of Laparoscopic Anterior Rectal Resection, once the colorectal anastomosis was performed, the terminal ileum was identified and a window in the mesentery was created to pass a rubber tube (we usually use an urinary catheter) around the intestinal loop. The tube was subsequently exteriorized trough the trocar incision in the right flank.
16139644|NCT01861366|Other|A one year multifaceted implementation strategy|
16139645|NCT01861366|Other|A three hour lecture about the guidelines|
16139646|NCT01861353|Other|Cranberry-lingonberry juice|
16140068|NCT01858246|Device|Bone Anchored Hearing Aid|
16139647|NCT01861353|Other|Placebo juice|Juice iwth similar sugar concentration as cranberry-lingonberry juice but without berry extracts
16139648|NCT01861340|Drug|Lenalidomide, Dexamethasone, and MEDI-551|Patients will receive Lenalidomide and dexamethasone as per standard of care. Patients with a clinical response after 2 cycles will get 2 cycles of MEDI-551.
16139649|NCT01861327|Drug|CO2|carbon dioxide (CO2) as arterial contrast media
16139650|NCT01861327|Drug|Iodine contrast media|Iodine as arterial contrast media
16139651|NCT01861314|Drug|Bortezomib|Given SC
16139652|NCT01861314|Drug|Decitabine|Given IV
16139653|NCT01861314|Other|Laboratory Biomarker Analysis|Correlative studies
16139654|NCT01861314|Other|Pharmacological Study|Correlative studies
16139655|NCT01861314|Drug|Sorafenib Tosylate|Given PO
16139656|NCT01861301|Other|Laboratory Biomarker Analysis|Correlative studies
16139657|NCT01861301|Drug|Tivantinib|Given PO
16139658|NCT01861275|Device|Nasal CPAP|Nasal CPAP treatment for obstructive sleep apnoea
16139659|NCT01861262|Device|Measurement of StO2|The procedure is a measurement and non-invasive monitoring system of percentage of oxygen saturation of haemoglobin in tissues using infrared technology. The system used in the study is the tissue oxygenation monitor InSpectraTM StO2 Spot Check, Model 300 consisting of a clamp applied to the base of the thumb of the patient.
16139660|NCT01861249|Drug|SAR339658|"Pharmaceutical form: Solution for infusion
~Route of administration: Intravenous"
16139661|NCT01861236|Drug|Firmagon® (degarelix)|Monthly subcutaneous injections
16139662|NCT01861223|Drug|afatinib (30 or 40mg) + nimotuzumab (100 or 200mg)|
16139663|NCT01861210|Behavioral|Couples Voluntary HIV Counseling and Testing|
16139664|NCT01861210|Behavioral|Individual Counseling and Testing|
16139665|NCT01861197|Drug|Dovitinib|Dovitinib 500mg daily for 5 days on/ 2 day off until progression
16139666|NCT01861171|Dietary Supplement|Green Tea|Twenty women with obesity and pre-hypertension, aged 28-59 years, with stable body weight were randomized to receive a daily supplement of 3 capsules that contained either 500mg of green tea extract (GTE) or a matching placebo for 4 weeks, with a washout period of 2 weeks between the treatments.
16139667|NCT01861158|Behavioral|Parenting Wisely|Computer-based, online, interactive parenting intervention
16139668|NCT01861145|Device|Bed Alarm|The bed alarm is a device that is worn at night with a sensor in the child's underwear. The alarm will activate when the child urinates, helping the brain to link the sensation of a full bladder with wakening.
16139669|NCT01861145|Drug|Nasonex|Intranasal steroids are used by otolaryngologists as first line treatment for adenotonsillar hypertrophy in children with suspected sleep-disordered breathing and obstructive sleep apnea. The spray helps to shrink the size of the adenoids and tonsils, diminishing the amount of tissue obstructing the child's airway.
16139670|NCT01861119|Drug|Silicone gel Kelo-cort™;|
16139671|NCT01861119|Drug|Onion extract gel Contractubex™|
16139682|NCT01861067|Procedure|LESS-TLH|
16139683|NCT01861067|Procedure|LESS-LAVH|
16139684|NCT01861054|Drug|Reparixin|1000 mg Oral Reparixin t.i.d. for 21 consecutive days prior to surgery
16139685|NCT01861041|Drug|Heavy Bupivacaine|7,5 mg intrathecal hyperbaric bupivacain,
16139686|NCT01861041|Drug|Isobaric Bupivacaine|7.5 mg intratecal isobaric bupivacain
16139687|NCT01861015|Drug|Epinephrine|
16139688|NCT01861015|Drug|Vasopressin|
16139689|NCT01861002|Drug|Azacytidine|Dose assigned at study entry (75 mg/m2/day). Given subcutaneously, once daily on days 1 to 5, for a total of 5 doses.
16139690|NCT01861002|Drug|Fludarabine|30 mg/m2/dose, intravenous infusion over 30 minutes, once daily, on days 6 to 10, total 5 doses
16139691|NCT01861002|Drug|Cytarabine|2000 mg/m2/dose intravenous infusion over 3 hours, starting 4 hours after the beginning of fludarabine, once daily, on days 6 to 10, total 5 doses.
16139692|NCT01861002|Drug|Intrathecal (IT) Cytarabine|"Intrathecally to AML patients on day 1 of course 1 and 2.
~Omit on day 1 of course 1 if patient received IT therapy within 7 days prior to study enrollment
~IT therapy may be given during the end of course 1 disease evaluation and repeated every 7 days
~For patients with CNS disease, IT cytarabine can be given weekly until the CSF is clear. Two additional doses of IT cytarabine should be given weekly after the initial CSF clearing. It is permitted to change to intrathecal triple therapy (ITT) if persistent blasts are present in the CSF based on the treating physician's clinical judgment. Cytarabine dose defined by age:
~30 mg for patients age 1-1.99
~50 mg for patients age 2-2.99
~70 mg for patients >3 years of age
~ITT Dosing:
~Age (yrs) - Dose Methotrexate (MTX), Hydrocortisone (HC), Cytarabine (ARAC):
~- 1.99 MTX: 8 mg, HC: 15 mg, ARAC: 30 mg
~- 2.99 MTX: 10 mg, HC: 25 mg, ARAC: 50 mg
~3 - MTX: 12 mg, HC: 35 mg, ARAC: 70 mg"
16140013|NCT01858649|Drug|Bevacizumab|Bevacizumab 5 mg/kg in 100 ml NaCl 0.9% IV infusion 3 to 5 cycles. No bevacizumab for ultimate cycle .
16139693|NCT01861002|Drug|Intrathecal Methotrexate (IT MTX)|"Intrathecally to patients with ALL on day 1 of course 1 and 2.
~Omit IT MTX on Day 1 of course 1 if patient received IT therapy within 7 days prior to study enrollment
~IT therapy may be given during the end of course 1 disease evaluation and repeated every 7 days
~For patients with CNS 2 or 3 disease, IT MTX can be given weekly until the CSF is clear. Two additional doses of IT MTX should be given weekly after the initial clearing of the CSF. It is permitted to change to ITT if persistent blasts are present in the CSF. Methotrexate dose defined by age
~8 mg for patients age 1-1.99
~10 mg for patients age 2-2.99
~12 mg for patients 3-8.99 years of age
~15 mg for patients >9 years of age
~Triple IT Therapy Dosing:
~Age (yrs): Dose Methotrexate (MTX), Hydrocortisone (HC), Cytarabine (ARAC):
~- 1.99 MTX: 8 mg, HC: 8 mg, ARAC: 16 mg
~- 2.99 MTX: 10 mg, HC: 10 mg, ARAC: 20 mg
~- 8.99 MTX: 12 mg, HC: 12 mg, ARAC: 24 mg
~9 MTX: 15 mg, HC: 15 mg, ARAC: 30 mg"
16139694|NCT01860989|Drug|KAE609|KAE609 75mg single dose
16139695|NCT01860989|Drug|KAE609|KAE609 150mg single dose
16139696|NCT01860989|Drug|KAE609|KAE609 225mg single dose
16139697|NCT01860989|Drug|KAE609|KAE609 300mg single dose
16139698|NCT01860976|Drug|Abatacept|
16139699|NCT01860976|Drug|Placebo|
16139700|NCT01860963|Procedure|Anal Pap smear and HPV DNA testing|Anal Pap smear is a standard diagnostic test used for early detection of pre-cancerous cells and anal HPV.
16139701|NCT01860950|Device|anodal tDCS|a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode electrode placed over the left DLPFC and the cathode electrode attached to the right shoulder
16139702|NCT01860950|Device|cathodal tDCS|a single 20-minute session of transcranial direct current stimulation (tDCS) with the anode attached to the right shoulder and the cathode electrode placed over the left DLPFC.
16139703|NCT01860950|Device|sham tDCS|Participants were provided pain education during 20 minutes of sham tDCS. For sham, the device was turned on for 30 seconds to temporarily mimic tingling and skin sensations of real tDCS and then ramped-down to 0mA for the duration of the 20-minute session
16139704|NCT01860937|Procedure|leukapheresis or collection of PBMCs|
16139705|NCT01860937|Drug|cyclophosphamide based chemotherapy regimens|
16139706|NCT01860937|Biological|modified T cells|
16139707|NCT01860924|Behavioral|exercise|vigorous intensity exercise
16139708|NCT01860924|Behavioral|health education|education
16139709|NCT01860911|Drug|Insulin|
16139710|NCT01860911|Drug|NG-monomethyl-L-arginine|
16139711|NCT01860898|Other|Skin Biopsy|Biopsy samples will be taken as a 2mm x 2cm excision of a wedge of skin at the edge of the incision during your surgery at the Mayo Clinic Rochester. Such excisions are frequently done as part of routine skin closure for optimal skin cosmesis following the surgical procedure.
16139712|NCT01860859|Procedure|Closure of the hysterotomy at the time of primary cesarean|
16139713|NCT01860833|Drug|Ibuprofen|time of treatment 14 days
16139714|NCT01860833|Drug|Celecoxib|time of treatment 14 days
16139715|NCT01860833|Drug|Diclofenac|time of treatment 14 days
16139717|NCT01860807|Drug|Ibudilast|
16139718|NCT01860807|Drug|Placebo|
16139719|NCT01860794|Drug|Mesencephalic Neuronal Precursor Cells|All the patients are continuously registered for this study. Data monitoring committee inspects the clinical results of first patient and decides whether the treatment for four subjects are appropriate to proceed. 5 subjects of each group are subject to inspection by Data monitoring committee after the end of tracking fifth patients.
16139720|NCT01860781|Drug|paliperidone palmitate|paliperidone palmitate 150mgeq(1 day), 100mgeq(8days), 75mg(monthly)
16139721|NCT01860755|Other|Control postural education, general range of motion and strengthening in addition to the standard of care|Control: postural education, general range of motion and strengthening in addition to the standard of care rest followed by graded exertion. Individuals were seen once weekly for eight weeks or until time of medical clearance to return to sport.
16139722|NCT01860755|Other|Physiotherapy|Physiotherapy: including vestibular rehabilitation and multimodal treatment for the cervical spine, once weekly with the study physiotherapist for 8 weeks or until time of medical clearance to return to sport.
16139723|NCT01860742|Drug|Interferon alpha-2b|Interferon α-2b in a dose of 5000000 Units administered subcutaneously every second day
16139724|NCT01860742|Drug|177Lu-DOTATATE|177Lu-octreotate infusions in fixed activities of 7,4 GigaBecqurel each, given 8-11 weeks apart, injected intravenously with simultaneous infusion of an amino acid solution
16139725|NCT01860729|Drug|Anacetrapib|
16139726|NCT01860729|Drug|Placebo|
16139727|NCT01860716|Drug|Melatonin|Melatonin 2 mg prolonged-release tablet, administration via nasogastric tube.
16139728|NCT01860716|Drug|Placebo|
16139729|NCT01860703|Drug|Deferiprone|Ferriprox 500 mg tablets
16139730|NCT01860703|Drug|deferiprone matching placebo tablets|deferiprone matching placebo tablets
16139731|NCT01860703|Drug|moxifloxacin|Active control
16139732|NCT01860703|Drug|placebo|moxifloxacin-matching placebo
16139733|NCT01860690|Drug|Methotrexate|50 mg / meter squer Intramuscular (IM) MTX.
16139734|NCT01860677|Device|Fisher Wallace Cranial Stimulator|The Fisher Wallace Cranial Stimulator device generates micro currents of electricity using a patented series of radio frequencies.
16139735|NCT01860664|Drug|hydrocortisone ophthalmic ointment 0.5%|"Patients will be instructed to apply Hydrocortisone Ophthalmic Ointment 0.5% or placebo in the lower cul de sac or lid margin BID
~Patients will be instructed to not use the study medications at least 2 hours prior to their appointment.
~Study medication dosing details:
~0.05 grams hydrocortisone per gram of combination product
~each application equal to 1/20th of a gram
~total amount of active ingredient applied to each eye per application = 0.0025 grams hydrocortisone
~total amount hydrocortisone applied per eye per day = 0.005 grams hydrocortisone
~Total amount of active ingredient applied per eye throughout duration of the two week study = 0.07 grams hydrocortisone"
16139736|NCT01860664|Drug|placebo|Mineral oil and white petrolatum
16139737|NCT01860651|Behavioral|Web-monitoring|During the E-health intervention, symptoms and FC are monitored closely through the web-program and treatment will be initiated by symptoms and elevated FC.
16139960|NCT01858948|Drug|Quetiapine fumarate|Patients will be started on 100 mg BID of quetiapine, and the dose adjusted based on tolerability and response. The quetiapine target dose is 400-600 mg.
16139738|NCT01860638|Drug|Bevacizumab|Bevacizumab will be administered at a dose of 10 milligrams per kilogram (mg/kg) intravenous (IV) every 2 weeks (Q2W) throughout the study, with the exception of bevacizumab monotherapy prior to PD1, which will be given as 15 mg/kg IV every 3 weeks (Q3W).
16139739|NCT01860638|Drug|Lomustine|Lomustine will be administered at a dose of 90 milligrams per square meter (mg/m^2) orally (PO) every 6 weeks (Q6W), with a cap of 160 milligrams (mg) per dose. In the absence of hematologic toxicity following the first dose, the second and subsequent doses may be increased to 110 mg/m^2 PO Q6W, with a cap of 200 mg per dose.
16139740|NCT01860638|Drug|Placebo|Placebo will be administered via IV infusion, in a formulation matched to bevacizumab, Q2W after randomization.
16139741|NCT01860638|Radiation|Radiotherapy|Radiotherapy will be administered for a total dose of 60 Gray (Gy), administered in 2-Gy fractions, 5 days per week for 6 weeks during first-line treatment.
16139742|NCT01860638|Drug|Temozolomide|Temozolomide will be administered orally (PO) as 75 mg/m^2 per day for the first 6 weeks of first-line treatment (concurrent treatment), followed by 6 cycles (28 days each) as follows: 150 mg/m^2 per day for the first 5 days of Cycle 1, then 200 mg/m^2 per day (if permitted by the participant's hematological and non-hematological toxicity profile) for the first 5 days of Cycles 2-6.
16139743|NCT01860638|Drug|SOC Agent|The choice of SOC agent will be at the discretion of investigator. The SOC agent will be administered during third-line treatment and subsequent lines, as per standard practice.
16139744|NCT01860625|Drug|Donepezil patch|
16139745|NCT01860625|Drug|placebo|
16139746|NCT01860612|Device|Artificial Iris (CustomFlex)|
16139747|NCT01860599|Behavioral|Exercise|150 minutes of moderate exercise per week
16139748|NCT01860599|Behavioral|Without exercise|Pre-study activity level (i.e. no exercise)
16139749|NCT01860586|Drug|Bevacizumab|Bevacizumab (1.25mg/0.05mL) will be injected into the study eye, at the end of the surgical repair of the retinal detachment and at Month 1, 2 and 3.
16139750|NCT01860573|Drug|Amino acids|
16139751|NCT01860560|Device|High-Flow Therapy|Blower-based High Flow Therapy delivered by nasal cannula
16139752|NCT01860560|Device|Continuous Positive Airway Pressure|CPAP Therapy delivered by laboratory Positive Airway Pressure titration device.
16139753|NCT01860547|Dietary Supplement|Bilberries|Frozen bilberries, 100 g/d
16139754|NCT01860547|Dietary Supplement|Sea buckthorn berry|Dried sea buckthorn berries, 20 g/d
16139755|NCT01860547|Dietary Supplement|Sea buckthorn phenolic extract|Ethanol-water extract from sea buckthorn berries, combined with maltodextrin, 14.6 g/d (7.3 g sea buckthorn extract + 7.3 g maltodextrin)
16139756|NCT01860547|Dietary Supplement|Sea buckthorn oil|Sea buckthorn oil, 4 g (8 capsules)/d
16139757|NCT01860534|Behavioral|eye covers|The infants were randomly assigned by alternating enrolled patients between one of two groups prior to their first ROP screening. Group A was patched for their first ROP exam and then unpatched for their second exam while group B was unpatched for their first ROP exam and unpatched for their second exam. The patched subjects had eye covers after their eyes were dilated, and the unpatched subjects had comfort measures similar to the patched subjects but their eyes were not covered. The patching of the eyes was done in the same way that it is done for eye protection during phototherapy, with the same model of eye patches (Natus biliband) and with the same nursing care.
16139758|NCT01860521|Procedure|Programmed Intermittent Epidural Bolus|An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL, 10 mL every hour, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered.
16139759|NCT01860521|Procedure|Continuous Epidural Infusion|An initial epidural loading dose consisting of 0.0625% levobupivacaine 20 mL (Chirocaine®, Abbott, Chicago, USA) plus sufentanil 10 µg (Fentatienil®, Angelini, Rome, Italy) was followed by 0.0625% levobupivacaine with sufentanil 0.5 µg/mL at a rate of 10 mL/h, starting 60 minutes after the administration of the initial epidural loading dose until expulsion of the fetus. If the patient still felt pain (VAPS score ≥ 30mm), despite the analgesia, additional manual incremental boluses of 5-mL levobupivacaine 0.125% until the VAPS score was < 30 mm were administered.
16139760|NCT01860521|Procedure|Procedure of interruption of pregnancy|Patients were administered 1 mg of gemeprost pessaries (Cervidil®, Merck Serono SPA, Roma, Italy) in the posterior fornix of the vagina every 3 hours up to 5 doses. If the expulsion of the fetus did not occur, the therapeutic regimen was repeated after 24 hours from the initiation of the treatment. Induction-to-abortion time (hours) was considered the period of time comprised between the first gemeprost pessary administration and fetal expulsion. Failure of induction of abortion was defined as women undelivered after two completed cycles (48h).The evacuation of the uterus under general anesthesia was performed if ultrasonography showed retained productions of conception.
16139761|NCT01860521|Drug|Drug used for analgesia procedures|Levobupivacaine (Chirocaine®, Abbott, Chicago, IL, USA) and sufentanil(Fentatienil®, Angelini, Rome, Italy) were administered in both study groups according to the regimen of each intervention arm (Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion).
16139762|NCT01860521|Device|Pump for programmed intermittent bolus.|Pump administering programmed intermittent epidural bolus for the maintenance of analgesia was used.
16139763|NCT01860521|Device|Pump for continuous epidural infusion.|Pump administering continuous epidural infusion for the maintenance of analgesia was used.
16139764|NCT01860521|Drug|Drug used for termination of pregnancy procedure.|Gemeprost pessaries.
16139765|NCT01860508|Drug|pemetrexed /carboplatin|
16139766|NCT01860495|Procedure|perforated membrane|perforated membrane that could give a chance for posetive contributionn of periosteal and gingival mesenchymal stem cells in periodontal regeneration
16139767|NCT01860495|Procedure|G2|tradetional occlusive collagen membrane
16139768|NCT01860482|Drug|Newrabell® Tablet 10mg|
16139769|NCT01860469|Procedure|vancomycin-soaked mesh|
16139770|NCT01860469|Procedure|plain mesh|
16139771|NCT01860456|Drug|Imatinib/Nilotinib|Imatinib: 400 mg/day oral - Nilotinib: 600-800 mg/day oral
16139961|NCT01858935|Drug|ND-L02-s0201 Injection|Single IV infusion.
16139962|NCT01858935|Drug|Placebo|Single IV infusion.
16139772|NCT01860443|Other|Telepsychiatry collaborative program|"The intervention includes:
~Online training for the health staff
~Medical and psychological treatment, as described in the AUGE Clinical Guidelines for Depression
~Online supervision in a web platform by specialists
~Telephone monitoring"
16139773|NCT01860443|Other|Usual care|"Online training for the health staff
~Medical and psychological treatment, as described in the AUGE Clinical Guidelines for Depression"
16139774|NCT01860417|Biological|Allogenic Mesenchymal Stromal Cells|
16139775|NCT01860417|Drug|Mepivacaine|
16139776|NCT01860404|Drug|Branched Chain Amino Acids|The three BCAA's will be combined together and dissolved in a flavored solution.
16139777|NCT01860404|Drug|Placebo solution|The placebo solution will have similar taste, texture, consistency and appearance as the BCAA solution.
16139778|NCT01860391|Device|Diammine Silver Fluoride|Diammine SIlver Fluoride will be applied to teeth. The levels of silver and fluoride in saliva will be measure up to 7 days
16139779|NCT01860378|Other|Full price|Participants will receive a voucher for the full price of a Tdap vaccine ($63.99) + a baby care product voucher or gift card
16139780|NCT01860378|Other|$5 off|Participants will receive a voucher for $5 off a Tdap vaccine + a baby care product voucher or gift card.
16139781|NCT01860365|Other|Complementary medicine consultation and treatment|Patients receiving chemotherapy will be referred by their oncology provider to complementary medicine (CM) consultation and treatment provided in addition to conventional supportive care.CM consultation will include assessment of patients' concerns and well-being, current CM use (including herbal and nutritional supplements), and construction of CM treatment based on efficacy and safety considerations.
16139782|NCT01860365|Other|Patients receiving conventional supportive care|Patients receiving chemotherapy will be offered assessment of their concerns and well-being as well as their current complementary medicine (CM) use (including herbal and nutritional supplements). Patients in this arm study will receive conventional supportive care with no added CM consultation or treatment.
16139783|NCT01860352|Dietary Supplement|Fish OIl|
16139784|NCT01860326|Drug|Alisporivir|Capsules supplied as open labeled bulk medication in 10-unit blister packages
16139785|NCT01860313|Behavioral|Web-based interactive education|An educational program for training teachers and educators to better recognize mental health problems in adolescents and children
16139786|NCT01860313|Behavioral|Text and Video-based education|This group received the material that composed the web-based education environment without any kind of interactivity. This material was composed by some videos about children mental health and a support text.
16139787|NCT01860300|Drug|Amoxicillin-Potassium Clavulanate Combination|Amoxicillin-Potassium Clavulanate Combination will be prescribed at the dose of 25/3.6 mg/kg/day for 10 days, 2 times/day, as oral suspension.
16139788|NCT01860300|Drug|placebo|
16139789|NCT01860287|Drug|Buprenorphine 0.2 MG Sublingual Tablet|This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive sublingual buprenorphine (0.2)
16139790|NCT01860287|Drug|Placebo|This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive a placebo
16139791|NCT01860287|Drug|Buprenorphine 0.4 MG Sublingual Tablet|This is a within-subjects, double-blind, placebo-controlled experiment during which each participant will receive sublingual buprenorphine (0.4)
16139792|NCT01860274|Device|External Mesh for vein grafts|
16139793|NCT01860261|Behavioral|Aerobic and Strength Training Intervention|The exercise intervention has three components: (1) aerobic exercise with a metabolic equivalent of task (MET) energy expenditure of at least 900 MET-minutes per week; (2) strength training consisting of 2 sets of 4 upper body exercises (bench press, seated row, shoulder press, and pull down), 3 sets of 3 leg exercises (leg press, extension, and flexion) and 2 sets each of abdominal crunches and back extensions. Weights for each exercise will be gradually increased as participants can complete 12 repetitions for each set on 2 consecutive sessions, with participants performing strength training twice per week total. Three workshops on using ChiWalking or ChiRunning technique for achievement of aerobic activity goals will be provided to participants in the experimental arm.
16139794|NCT01860248|Drug|Vapocoolant spray|The Vapocoolant spray containing alkane is applied for 20 seconds.
16139795|NCT01860248|Drug|Water spray|This spray is covered so the patient and the investigator can not find the spray type out.
16139796|NCT01860235|Drug|EMLA|% eutectic mixture of 25mg/g lidocaine and 25 mg/g of prilocaine
16139797|NCT01860235|Drug|Injectable anesthesia|Injectable anesthesia 2% lidocaine with epinephrine 1:100.000
16139798|NCT01860235|Drug|2% Benzocaine|Topical anesthetic - 200mg/g of 2% benzocaine
16139799|NCT01860235|Drug|Placebo|Manipulated with the same appearance and viscosity of topical anesthetics mentioned above
16139800|NCT01860222|Procedure|SR|
16139801|NCT01860222|Procedure|PLAT|
16139802|NCT01860209|Procedure|Hemodialysis|Intermittent ambulatory hemodialysis session, according to the patient usual protocol (defined by the treating nephrologist independently of the study)
16139803|NCT01860196|Drug|Meditoxin|
16139804|NCT01860196|Drug|Normal saline|
16139806|NCT01860170|Drug|Cohort 1-Bortezomib (Velcade ®)|"Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.
~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.
~Bortezomib 0.7 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
16140014|NCT01858649|Drug|5 FU|Leucovorin L (levoleucovorin) 200 mg/m2 (or folinic acid 400 mg/m²) in 250 ml glucose 5%, IV infusion 3 to 6 cycles 5-FU bolus 400 mg/m2, IV bolus 3 to 6 cycles 5-FU continuous infusion 2400 mg/m2, 46-hour cont. IV infusion 3 to 6 cycles
16140015|NCT01858649|Drug|Oxaliplatin|oxaliplatin 85 mg/m² in 150 ml NaCl 0.9%, IV infusion 3 to 6 cycles
16140016|NCT01858649|Drug|Irinotecan|Irinotecan 180 mg/m² in 150 ml NaCl 0.9%, IV infusion 3 to 6 cycles
16139807|NCT01860170|Drug|Cohort 2-Bortezomib (Velcade ®)|"Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.
~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.
~Bortezomib 1 mg/ m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
16139808|NCT01860170|Drug|Cohort 3-Bortezomib (Velcade ®)|"Conditioning Regimen: Fludarabine 30 mg/m2 on days -7, -6, -5, -4, -3 and -2; Busulfan 0.8 mg/kg, every 6 hours on days -3 and -2; Patients with matched unrelated donor also receive rATG (Thymoglobulin ®) 2 mg/kg on days -4, -3, -2 and -1.
~Cyclophosphamide 50 mg/kg, in 500 mL NS over 2 hours on days +3 and +4. Concomitant hydration with NS with 20 mEq/L at 250 mL/hr starting 4 hours before and continuing until 24 hours after the second dose is given. Furosemide on as needed basis to maintain fluid balance is also given. It is important to avoid administration of any immunosuppressive drugs include steroids after day 0.
~Bortezomib 1.3 mg/m2 rapid IV push on days 0 (at least 6 hours after transplant) and +3."
16139809|NCT01860157|Device|Brainsway H1-Coil Deep TMS System (Sham treatment)|In the sham treatment,the electrical field induced by the sham coil cannot invoke any action potentials and if no action potentials are induced, then the electric field is insignificant and there is no treatment effect on the brain.
16139810|NCT01860157|Device|Brainsway H1-Coil Deep TMS System|Deep Transcranial Magnetic Stimulation (DTMS) is a new form of TMS which allows direct stimulation of deeper neuronal pathways than the standard TMS. The H-coil is a novel DTMS coil designed to allow deeper brain stimulation without a significant increase of electric fields induced in superficial cortical regions
16139811|NCT01860144|Drug|Bevacizumab|
16139812|NCT01860131|Behavioral|Weight Wise Community Modules|Program designed to educate patients regarding proper diet, exercise,and behavioural modification techniques with emphasis on increasing self-management, enhancing self-efficacy and identifying/overcoming barriers to success.
16139813|NCT01860105|Drug|MDCO-157|intravenous administration
16139814|NCT01860105|Drug|PLAVIX|oral administration
16139815|NCT01860079|Procedure|early discharge|In the early discharge group, patients are actively targeted for hospital discharge within 48-56 hours.
16139816|NCT01860066|Drug|QVA149|QVA149 via inhaler twice a day
16139817|NCT01860066|Drug|fluticasone/salmeterol|fluticasone/salmeterol via inhaler twice a day
16139818|NCT01860053|Behavioral|behavioral intervention|This intervention targets eating behavior to reduce vomiting and associated complications in post-operative LAGB patients.
16139819|NCT01860040|Drug|Cisplatin|Alkylating antineoplastic agent (Chemotherapy)
16139820|NCT01860040|Drug|Pemetrexed|Antimetabolite antineoplastic agent (Chemotherapy)
16139821|NCT01860040|Drug|Gemcitabine|Antimetabolite antineoplastic agent (Chemotherapy)
16139822|NCT01860014|Drug|Poractant alfa|Curosurf: 100 mg/kg-intratracheal, just after pulmonary hemorrhage
16139823|NCT01860014|Drug|Beractant|Survanta: 100 mg/kg-intratracheal, just after pulmonary hemorrhage
16139824|NCT01859988|Drug|Dupilumab|
16139825|NCT01859988|Drug|Placebo|
16139826|NCT01859962|Drug|PPI-668|
16139827|NCT01859962|Drug|BI 207127 Dose 1|
16139828|NCT01859962|Drug|BI 207127 Dose 2|
16139829|NCT01859962|Drug|Faldaprevir|
16139830|NCT01859962|Drug|Ribavirin|
16139831|NCT01859962|Drug|BI 207127 Placebo|
16139832|NCT01859949|Drug|Genotropin (somatropin)|Genotropin(somatoropin) 12 mg, Genotropin(somatropin) will be given at a dose of 0.067 mg/kg/day or 0.033 mg/kg/day to all participating patients
16139833|NCT01859936|Device|MRI|The intervention is that preoperative MRI breast will be performed in 220 women under 56 years with newly diagnosed breast cancer. Aims are to analyze if the intervention will affect primary management, decrease the number of reoperations and to analyze if the intervention leads to an increasing number of unnecessary mastectomies compared to the non intervention arm.
16139834|NCT01859923|Drug|Delamanid|Participants received adult formulation delamanid as per regimen specified in the arm description. Morning dose of the delamanid BID regimen was given within 30 minutes after the start of a standard breakfast meal. The evening dose of the BID dose regimen was given 10 hours post morning dose and within 30 minutes after the start of a standard dinner meal.
16139835|NCT01859923|Drug|Delamanid Pediatric Formulation (DPF)|Participants received delamanid as an extemporaneous suspension using the delamanid pediatric dispersible tablet formulation. Morning dose of the delamanid BID/once daily (QD) regimen was given within 30 minutes after the start of a standard breakfast meal. The evening dose of the BID dose regimen was given 10 hours post morning dose and within 30 minutes after the start of a standard meal.
16139836|NCT01859923|Drug|Optimized Background Regimen (OBR)|"Selection and administration of the treatment medications (i.e. OBRs) was based on Search Results Web result with site links
~World Health Organization (WHO's) Guidelines for the programmatic management of drug-resistant TB, in conjunction with national TB program guidelines. Study Investigator could change OBR for a participant based on his/her tolerability and drug susceptibility testing (DST) results."
16139837|NCT01859910|Procedure|compression and scrub of lid margin|compression and scrub of lid margin for 5 circles before cataract surgery
16139838|NCT01859910|Procedure|routine preparation for cataract|
16139839|NCT01859884|Behavioral|Inform Me: web-based education tool|The purpose of Inform Me is to help kidney transplant candidates understand what kidneys from increased risk donors are and describes the risks and benefits of accepting and refusing a kidney from an increased risk donor. Increased risk donors are donors who engaged in behaviors that increase their chances of having: Human Immunodeficiency Virus, Hepatitis B Virus , Hepatitis C Virus. Inform Me focuses only on increased risk donor kidneys. Inform Me aims to prepare patients to make a decision with their transplant team to accept or to refuse a kidney from an increased risk donor. Inform Me does not try to convince patients to accept or refuse a kidney from increased risk donors.
16140017|NCT01858636|Device|Angio-Seal VIP 6 French (6F) and 8 French (8F) devices|These devices are used for the vascular closure procedure
16140018|NCT01858623|Drug|Losartan/hydrochlorothiazide|
16140019|NCT01858623|Drug|Losartan|
16140020|NCT01858623|Drug|Hydrochlorothiazide|
16139840|NCT01859871|Behavioral|Website Intervention|Study participants will take the self-administered pre-test in the intervention arm and will be introduced to the website to inform the public of various topics concerning end-stage kidney disease and kidney transplantation. Few websites about transplantation are tailored to potential Hispanic kidney transplant candidates or the Hispanic community. This website is designed to fill the void and be an effective bilingual web-based educational resource targeted to Hispanic patients and public which can serve as a culturally competent tool to enhance knowledge and attitudes about living kidney donation.
16139841|NCT01859858|Dietary Supplement|curcumin|
16139842|NCT01859858|Drug|Irinotecan|
16139843|NCT01859845|Other|Smartphone|"Our team of dermatologists and biomechanical engineers led by the PI developed a simulation skills training prototype device using a smartphone. Software was developed to teach dermoscopic evaluation of pigmented lesions using the three-poin checklist of dermoscopy. The software used in the smartphone presentation of the educational intervention also provides a decision tree of clinical management options and best-practices feedback. No patients are involved in this research."
16139844|NCT01859832|Other|Cylex ImmuKnow Assay|This is not an interventional study. However the assay being tested on the samples of all enrolled participants in the Cylex ImmuKnow Assay
16139845|NCT01859819|Drug|Rituximab|
16139846|NCT01859819|Drug|IT Cytarabine|
16139847|NCT01859806|Procedure|Pancreaticogastrostomy group|Standard PD with regional lymphadenectomy was performed. PG was done between pancreatic stump and posterior surface of the stomach with 2 layer interrupted anastomosis,and duct to mucosa.
16139848|NCT01859806|Procedure|Isolated Roux PJ group|Isolated Roux PJ group, reconstruction was begun using the transected jejunum and ,which was anastomosed in end to side fashion. A separate Roux loop was performed for HJ, by dividing the jejunum about 40 cm beyond the pancreatic anastomosis and GJ was done in this loop (30 cm caudally from HJ). The PJ loop was anastomosed to the main loop (20 cm caudal to GJ).
16139849|NCT01859793|Drug|sitagliptin|100 mg pill, administered once/day orally
16139850|NCT01859793|Drug|Placebo|Matching placebo in appearance given once/day orally
16139851|NCT01859780|Other|Visual distractor|
16139852|NCT01859767|Drug|[123I]MNI-672 SPECT|Subjects will be dosed by intravenous injection to a target dose of 5 mCi and not to exceed 5.5 (not >10% of 5 mCi limit) I-123 MNI-672 prior to the SPECT scan.
16139853|NCT01859754|Biological|Octagam 5%|Intravenous immunoglobulin 5%
16139854|NCT01859754|Biological|Other marketed IVIG product|Any intravenous immunoglobulin marketed product approved for the treatment of PID
16139855|NCT01859741|Drug|OMP-59R5|OMP-59R5 administered intravenously
16139856|NCT01859741|Drug|Etoposide|administered intravenously
16139857|NCT01859741|Drug|Placebo|administered IV
16139858|NCT01859741|Drug|Cisplatin or Carboplatin|administered intravenously
16139859|NCT01859728|Drug|Irinotecan|"Irinotecan 65mg/m² D1 and D8 q21 days, until disease progression or unacceptable toxicity.
~Given in association with standard hydration and anti-emetics."
16139860|NCT01859728|Drug|Cisplatin|"Cisplatin 60mg/m² D1 q 21 days, until disease progression or unacceptable toxicity.
~Given in association with standard hydration and anti-emetics."
16139861|NCT01859728|Drug|Cisplatin|"Cisplatin 25mg/m² D1 and D8 every 21 days, until disease progression or unacceptable toxicity. , with standard hydration and antiemetics.
~Given in association with standard hydration and anti-emetics."
16139862|NCT01859728|Drug|Gemcitabine|"Gemcitabine 1000mg/m² D1 and D8 every 21 days, until disease progression or unacceptable toxicity.
~Given in association with standard hydration and anti-emetics."
16139863|NCT01859715|Drug|Oxycodone|Subjects given oxycodone 5mg by ED provider decision or by triage nurse randomization.
16139864|NCT01859715|Drug|Hydrocodone|Subjects given hydrocodone/acetaminophen 5mg/500mg by ED provider decision or by triage nurse randomization.
16139865|NCT01859715|Drug|Ondansetron|Subjects given ondansetron 4mg for reported nausea or vomiting. Treatment determined either by triage nursing protocol or by provider discretion. Observational intervention only.
16139866|NCT01859702|Drug|Moxifloxacin 0.5%/Dexamethasone 0.1% ophthalmic solution|
16139867|NCT01859689|Radiation|brachytherapy|Undergo image-guided HDR brachytherapy
16139868|NCT01859689|Radiation|image-guided radiation therapy|Undergo image-guided HDR brachytherapy
16139869|NCT01859689|Other|laboratory biomarker analysis|Correlative studies
16139870|NCT01859650|Other|MR and CT imaging|
16139871|NCT01859637|Biological|Filgrastim|Zarzio®/Filgrastim HEXAL® solution for injection was provided in prefilled syringes with two strengths at 300 μg/0.5 ml (30 MU) and 480 μg/0.5 ml (48 MU). Dosage and duration for each patient is as per the recommendations in the SmPC.
16139872|NCT01859624|Drug|Albuterol|Albuterol 4 mg
16139873|NCT01859611|Device|TriActive+ RF|"Radio frequency handpiece uses a multi-polar technology with a particular electrical frequency of 1MHz. The handpiece has a special skin contact identification system which delivers energy only when electrodes are adherent to the skin surface in order to avoid the prickling sensation when the treatment starts."
16139874|NCT01859585|Drug|Parecoxib|Parecoxib 40 mg intravenous
16139875|NCT01859585|Drug|Ketorolac|Ketorolac 30 mg intravenous
16139876|NCT01859559|Procedure|Ultrasound-guided peripheral intravenous access line placement|The ED technician will use an ultrasound machine with a vascular probe to visualize the vein and guide the PIV line using a one-operator dynamic technique.
16139877|NCT01859559|Procedure|Landmark Approach to peripheral intravenous access line placement|ED technician will use standard anatomical landmarks and palpation to puncture the skin and insert the peripheral intravenous access line in the upper extremity.
16139878|NCT01859546|Behavioral|Short message service|Short message service reminders on cell phones in improving the compliance of subsequent visits for routine immunization for children
16139879|NCT01859533|Device|Neopuff|"Group I neonates (Experimental group) includes 30 newborns showing signs of TTN who will receive administration of CPAP (5 cm of H2O) via T- piece (Neopuff; Fisher and Paykel Healthcare, Auckland, New Zealand).
~Group II neonates (Control group) includes 30 newborns who will receive nasal prong oxygen treatment; standard care according to Siva Subramanian et al. (2010)."
16140021|NCT01858610|Drug|Irbeasartan/hydrochlorothiazide|
16140022|NCT01858610|Drug|Irbesartan|
16140023|NCT01858610|Drug|Hydrochlorothiazide|
16140195|NCT01857362|Drug|Nitisinone 10 mg|Nitisinone 10 mg capsules
16139880|NCT01859520|Procedure|swim-up, density gradient sperm preparation techniques|Sperms are prepared by sperm washing techniques before used in assisted reproductive technologies. Most commonly used sperm preparation methods are the swim up and the density gradient. Recent studies shows that the DNA integrity status of the spermatozoa is related to the success in assisted reproduction techniques. Sperm preparation methods may theoretically cause damage sperm DNA. Therefore it is important to select the optimum method of sperm preparation causing least sperm DNA damage. Aim of our study is to investigate and compare the effect two different sperm preparation techniques on DNA fragmentation.
16139881|NCT01859507|Drug|Botox|In the first session, proper history taking and proper counseling of the couple including the description of the new modality (BOTOX injection) of treatment and subsequent dilatation sessions. During examination, all our maneuvers are gentle to gain trust of the patient. Following sterilization, we used surface (Xylocaine gel 2% ASTRA ZENECA) anesthesia before the injection. In addition we used finger like ice packs pre-prepared in a surgical latex glove, on the perineum. We made sure to check that the tip of the needle is not in a vessel by aspirating before proceeding with the injection of each bolus of BOTOX.
16139882|NCT01859494|Device|NINJA 3 Investigational Blood Glucose Monitoring System|Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.
16139883|NCT01859481|Drug|Placebo|All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.
16139884|NCT01859481|Drug|Eletriptan HBr 40 mg|All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.
16139885|NCT01859481|Drug|Eletriptan HBr 80 mg|All subjects will receive open label eletriptan 40 mg per attack for the first three attacks in the phase 1 of the study. For the next 4 attacks subjects will be assigned to either eletriptan 40 mg or 80 mg group based on the response in the phase 1 portion of the study. In phase II, in each group subjects will receive eletriptan 40 mg or 80 mg for 3 attacks and placebo for 1 attack. In each group double-blind placebo will be inserted at random.
16139886|NCT01859468|Dietary Supplement|Amorphous calcium carbonate|
16139887|NCT01859468|Other|Placebo|
16139888|NCT01859455|Drug|LGT209 50 mg|Active experimental drug
16139889|NCT01859455|Drug|LGT209 300 mg|Active experimental drug
16139890|NCT01859455|Drug|Placebo|Placebo comparator
16139891|NCT01859455|Drug|Statins (atorvastatin or simvastatin)|Stable doses of atorvastatin or simvastatin
16139892|NCT01859442|Procedure|Structured responsive interval exercise training programme|
16139893|NCT01859442|Other|Sham group|NO intervention in this group, only standard care (no exercise programme)
16139894|NCT01859429|Other|Stepped Care|Step 1: Screening for psychosocial distress Step 2: If a patient is moderately or highly distressed according to step 1, the physician performs a brief structured interview and arranges, if necessary, appropriate psychosocial care Step 3: psychosocial care as indicated by step 2
16139895|NCT01859416|Dietary Supplement|Oral nutritional supplement|
16139896|NCT01859403|Genetic|Personalized Genomics|A set of single nucleotide polymorphisms in genes important for obesity, eating behaviors and exercise
16139897|NCT01859403|Genetic|Usual Care|Patients receive the same dietary recommendation regardless of their genetic information
16139898|NCT01859390|Drug|AquADEKs-2|AquADEKs-2 contains standard amounts of fat-soluble vitamins (A, D, E, K) that are contained in typical CF multivitamin supplements plus several antioxidants including beta-carotene, mixed tocopherols (different forms of vitamin E), coenzyme Q10 (CoQ10), mixed carotenoids (lutein, lycopene and zeaxanthin), and the minerals zinc and selenium.
16139899|NCT01859390|Dietary Supplement|control multivitamin|The control multivitamin contains standard (standard for CF multivitamin supplements) amounts of vitamins A, B, D, E, and K without added antioxidants.
16139900|NCT01859377|Drug|V0498 - A mg|Single oromucosal administration
16139901|NCT01859377|Drug|Ibuprofen|Single oral administration
16139902|NCT01859351|Drug|WX-037|
16139903|NCT01859351|Drug|WX-554|
16139904|NCT01859338|Radiation|cone-beam computed tomography|Undergo CBCT
16139905|NCT01859338|Radiation|magnetic resonance imaging|Undergo MRI
16139906|NCT01859338|Radiation|computed tomography|Undergo fan beam computed tomography
16139907|NCT01859325|Biological|rVSV|Attenuated recombinant vesicular stomatitis virus containing HIV-1 gag gene
16139908|NCT01859325|Biological|IL-12 pDNA adjuvant|plasmid DNA containing human IL-12 gene
16139909|NCT01859325|Biological|HIV-Mag pDNA|plasmid DNA vaccine containing genes encoding multiple HIV-1 proteins
16139910|NCT01859325|Drug|Placebo|
16139911|NCT01859312|Drug|Hydrocortisone (Solucortef)|Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA). Total daily hydrocortisone dose was calculated based on the patient's estimated cortisol clearance. Rates were established to achieve peak and trough concentrations within the normal circadian cortisol range.
16139912|NCT01859312|Device|Insulin pump (Medtronic)|Continuous subcutaneous hydrocortisone infusion (CSHI) via Medtronic insulin pump (MMT-722NA)
16139963|NCT01858922|Drug|ABVE-PC|"Doxorubicin (A) 25mg/m2/day IV over 10min on Day 1 & Day 2
~Bleomycin (B) 5units/m2/day IV over 10min on Day 1 10units/m2/day IV over 10min on Day 8
~Vincristine (V) 1.4mg/m2/day IV push with extravasation precautions on Day 1 & 8 (Max dose 2.8mg)
~Etoposide (E) 125mg/m2/day IV over 1hr at a concentration of </=0.4mg/ml in NS on Day 1, 2 & 3
~Prednisone (P) 40mg/m2/day PO divided in 2 doses every day on Day 1-7 IV equivalent of methylprednisolone is acceptable
~Cyclophosphamide (C) 800 mg/m2 IV over 1 hr in 200 ml/m2 NS on Day 1"
16140063|NCT01858311|Other|Placebo Vehicle|Placebo capsules per day (2 in the morning and 2 in the evening)
16140064|NCT01858298|Other|Conservative treatment: pulpectomy and composite resin crown|
16139913|NCT01859286|Other|standardized sign out process|The intervention phase included was the introduction of a standardized TOC (transfer of care) process, which occurred during April and May of 2012. TOC was done at a predefined location in each section of the emergency department (Medicine and Trauma). All participating residents were given a diagram detailing the central location and seating arrangement. The outgoing attending was designated to handle all distractions or disturbances that occurred during sign out. The most senior resident coming on to shift was designated the data resident. The data resident's role was to operate a centralized computer with the ED tracking board and EMR and review pending orders, vital signs and resulted labs and radiology reports after each patient was signed out. A brief pause was implemented to allow the oncoming team to ask any questions regarding that patient's care or course. The post TOC data form and protocol were identical to that of the control phase.
16139914|NCT01859273|Behavioral|mHealth|mHealth prototype system consisting of electronic medication tray, blood pressure cuff and smart phone
16139915|NCT01859260|Device|CPAP/autopap|
16139916|NCT01859247|Device|rTMS|
16139917|NCT01859234|Drug|89Zr-bevacizumab|89Zr-bevacizumab will only be given once, prior for the PET scan. 5 mg will be given iv.
16139918|NCT01859221|Radiation|Stereotactic radiation|Stereotactic radiation
16139919|NCT01859182|Drug|selumetinib|Given PO
16139920|NCT01859182|Drug|Akt inhibitor MK2206|Given PO
16139921|NCT01859182|Other|laboratory biomarker analysis|Correlative studies
16139922|NCT01859182|Other|pharmacogenomic studies|Correlative studies
16139923|NCT01859182|Procedure|quality-of-life assessment|Ancillary studies
16139924|NCT01859169|Procedure|Photodynamic therapy|Each patient to whom PDT was offered underwent a specific, detailed educational process by a dedicated team member(P.B., P.J., or K.E.), after which informed consent was obtained.Porfimer sodium (Photofrin; Axcan Pharma Inc, Quebec, Canada)was used as a photo sensitizing agent, administered intravenously at a dose of 2 mg/kg body weight 48 hours before illumination.A diode laser system (InGaAIP Laser Diode; Diomed Inc, An-dover, MA) with a maximum power output of 2000 mW and a wavelength of 633+-3 nm was used as a light source, delivered through a 3.0-m length fiber having a 2.5-cm-long cylindrical diffuser at its distal end (Pioneer Optics, Windsor Locks, CT).
16139925|NCT01859143|Biological|Trivalent Influenza Vaccine|A single dose of 10^(7.0 ± 0.5) FFU of trivalent influenza vaccine will be administered as intranasal spray on Day 1.
16139926|NCT01859143|Other|Placebo|A single dose of placebo matched to trivalent influenza vaccine will be administered as intranasal spray on Day 1.
16139928|NCT01859117|Biological|3 x 10^6 cells|3 x 10^6 cells administered on Study Days 1 and 8
16139929|NCT01859117|Biological|10 x 10^6 cells|10 x 10^6 cells administered on Study Days 1 and 8
16139930|NCT01859117|Biological|30 x 10^6 cells|30 x 10^6 Human Placenta Derived cells (PDA-002) administered intramuscularly on Study Days 1 and 8
16139931|NCT01859117|Biological|100 x 10^6 cells|100 x 10^6 cells administered on Study Days 1 and 8
16139932|NCT01859104|Behavioral|Use of smartphone app|
16139933|NCT01859091|Device|The Zeltiq System|Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
16139934|NCT01859078|Drug|Baricitinib|Administered orally
16139935|NCT01859078|Drug|Digoxin|Administered orally
16139936|NCT01859065|Behavioral|Intensified anticipatory guidance|Mothers receive video-based and handout-based anticipatory guidance regarding non-urgent problems in addition to the routine anticipatory guidance
16139937|NCT01859065|Behavioral|Routine|Routine anticipatory guidance (control)
16139938|NCT01859052|Other|Low carbohydrate diet|Subjects will follow the Atkins for Life diet. They will be given the book and a study dietitian will guide them through the induction, ongoing weight loss, pre-maintenance, and lifetime maintenance phases.
16139939|NCT01859052|Other|Low calorie low fat diet|The diet will be a nutritionally balanced, hypocaloric diet with a deficit of 750 kcal/day as guided by TEE. The goal is to match the calorie deficit to the low-CHO diet
16139940|NCT01859052|Other|AHA diet recommendations|given information in accordance with the diet and lifestyle recommendations of the American Heart Association.
16139941|NCT01859039|Biological|Administration of Live attenuated influenza vaccine|
16139942|NCT01859026|Drug|MEK162|Treatment as outlined in study arms.
16139943|NCT01859026|Drug|Erlotinib|Treatment as outlined in study arms.
16139944|NCT01859013|Drug|Topiramate|Topiramate will be initiated at a dose of 25 mg (taken orally once daily in the evening), escalated to 50 mg (taken orally once daily in the evening) after 1 week, and escalated to 75 mg (taken orally 25 mg in the morning and 50 mg in the evening) after 2 weeks. Patients who do not tolerate dose escalation will be reduced to the highest tolerated dose for the remainder of the trial.
16139945|NCT01859013|Other|Placebo|Placebo will be taken orally once daily in the evening for the first two weeks, and orally twice daily (AM and PM) for the remainder of the study.
16139946|NCT01859000|Other|Multidimensional Family Therapy|MDFT assesses and intervenes in four domains to address comorbid substance abuse and trauma symptoms: 1) adolescent, 2) parent, 3) family, and 4) external systems. MDFT therapists will address trauma symptoms among both teens and parents, aiming to improve coping and reduce the impact of stress on the family. Consistent with a multidimensional approach, MDFT trauma-focused interventions address the needs of both youth and their parents, and MDFT therapists seek collaboration and advocacy from school and court personnel.
16139947|NCT01859000|Other|Group CBT|Trauma symptoms will be addressed using techniques designed to reduce cognitions that maintain anxiety and depressive symptoms and improve coping, such as cognitive restructuring, gradual exposure, and helping teens to understand and accept reminders of the event and ongoing stressors (Pynoos et al, 1998).
16139948|NCT01858987|Procedure|Stapler hepatectomy|Liver resection using vascular stapler for transection of the parenchyma
16139949|NCT01858987|Procedure|LigaSure hepatectomy|Liver resection using LigaSure for transection of the parenchyma
16139950|NCT01858987|Device|Ligasure|
16139951|NCT01858987|Other|vascular staple|
16139952|NCT01858961|Drug|BI 201335|Once a day
16139953|NCT01858961|Drug|ribavirin|Twice a day
16139954|NCT01858961|Drug|BI 207127|Twice a day
16139955|NCT01858961|Drug|Telaprevir|Three times a day
16139956|NCT01858961|Drug|ribavirin|Twice a day
16139964|NCT01858922|Drug|DECA|"Dexamethasone (D):
~10 mg/m2 IV over 15 minutes on Day 1 and Day 2, prior to Etoposide/Cytarabine.
~Etoposide (E):
~100 mg/m2 IV over 3 hours on Day 1 and Day 2 as continuous infusion mixed with cytarabine*
~Cytarabine (A):
~3000 mg/m2 IV over 3 hours on Day 1 and Day 2 as continuous infusion mixed with etoposide*
~*Mix together in NS at an etoposide concentration of </=0.4 mg/ml
~Dexamethasone eyedrops:
~2 drops in each eye 4 times a day on Day 1, Day 2, and Day 3.
~Cisplatin (C):
~90 mg/m2 over 6 hours in 1000 ml/m2 NS + 10 gram/m2 mannitol on Day 1 as continuous infusion."
16139965|NCT01858909|Drug|Melatonin|Administration via oral or via a nasogastric tube followed by 20mL saline
16139966|NCT01858896|Drug|Glucagon-Like Peptide- 1 (GLP-1) infusion|GLP-1 infusion during experimental period
16139967|NCT01858896|Other|Placebo Comparator: Saline Infusion|Saline infusion (placebo) during experimental period
16139968|NCT01858883|Drug|itacitinib|
16139969|NCT01858883|Drug|Gemcitabine|
16139970|NCT01858883|Drug|nab-paclitaxel|
16139971|NCT01858883|Drug|filgrastim|
16139972|NCT01858870|Drug|lacosamide|routine clinical practice
16139973|NCT01858844|Other|CHEST COMPRESSION TECHNIQUE (CCT)|The CCT was held with the placement of one of the hands were not engaged in. The following has been applied a symmetric oblique direction, pressure from top to bottom on the half thorax rib cage so that it went according to the complacency of the ribcage. This pressure was applied in the expiratory phase and held for 10 seconds, totaling 6 repetitions of the maneuver during 60 seconds. The other hand held on the contralateral iliac crest to stabilize the patient. The technique was held during 5 consecutive minutes with range of a respiratory incursion every 60 seconds. Immediately after and 10 minutes after the end of the application of the technique, the data was measured again.
16139974|NCT01858831|Drug|Atovaquone/proguanil HCL|Atovaquone/proguanil HCL
16139975|NCT01858831|Drug|Atovaquone|Atovaquone
16139976|NCT01858805|Procedure|esophagectomy|
16139977|NCT01858792|Drug|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
16139978|NCT01858792|Drug|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
16139979|NCT01858792|Other|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
16139980|NCT01858779|Behavioral|Measurement of peripheral pulse|All patients will be introduced and trained for the measurement of peripheral pulse. Patients will keep a pulse-diary tro detect atrial fibrillation.
16139981|NCT01858779|Device|72h holter ECG|All petients will receive regular 72h Holter ECG at 3 and 6 months after inclusion in the study.
16139982|NCT01858766|Drug|SOF|400 mg tablet administered orally once daily
16139983|NCT01858766|Drug|VEL|Tablet administered orally once daily
16139984|NCT01858766|Drug|RBV|200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16139985|NCT01858753|Biological|Autologous fibroblasts|
16139986|NCT01858753|Biological|placebo sterile saline|
16139987|NCT01858740|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo CD45RA+ T cell-depleted allogeneic peripheral blood stem cell transplant
16139988|NCT01858740|Drug|Fludarabine Phosphate|Given IV
16139989|NCT01858740|Other|Laboratory Biomarker Analysis|Correlative studies
16139990|NCT01858740|Drug|Methotrexate|Given IV
16139991|NCT01858740|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo CD45RA+ T cell-depleted allogeneic peripheral blood stem cell transplant
16139992|NCT01858740|Biological|T Cell-Depleted Hematopoietic Stem Cell Transplantation|Undergo CD45RA+ T cell-depleted allogeneic peripheral blood stem cell transplant
16139993|NCT01858740|Drug|Tacrolimus|Given IV or PO
16139994|NCT01858740|Drug|Thiotepa|Given IV
16139995|NCT01858740|Radiation|Total-Body Irradiation|Undergo TBI
16139996|NCT01858727|Other|forced air warming group|30 minutes before the preoperative will use forced air warming
16139997|NCT01858727|Other|control group|do not heating group
16139998|NCT01858714|Behavioral|Behavior Therapy for Weight Loss|Standard behavioral treatment for weight loss and weight loss maintenance.
16139999|NCT01858714|Behavioral|Behavior Therapy + Environment|Standard behavioral therapy with an emphasis on environmental strategies.
16140000|NCT01858714|Behavioral|Acceptance-based Behavior Therapy + Environment|Behavioral therapy with acceptance-based and environmental strategies.
16140001|NCT01858701|Device|Lotrafilcon B toric contact lens|Commercially available, silicone hydrogel contact lens for correction of astigmatism
16140002|NCT01858701|Device|Comfilcon A toric contact lens|Commercially available, silicone hydrogel contact lens for correction of astigmatism
16140003|NCT01858688|Device|Multiparametric MRI|an MRI of the prostate will be performed
16140004|NCT01858688|Procedure|Prostate biopsy|a biopsy of the prostate will be performed according to standard procedures for men on active surveillance
16140005|NCT01858675|Other|Biomarkers, red blood cells and plasma assessment|
16140006|NCT01858662|Procedure|Metastases Resection ( multiple steep surgery possible)|Metastases resection will be process by surgery, after a randomized chemotherapy (FOLFOX or FOLFIRI) + Target therapy (Cetuximab). The surgery will allow to compare the pathological response on the resected metastases by the chemotherapy + target therapy type.
16140007|NCT01858662|Drug|5-Fluorouracile|5-FU bolus 400 mg/m2, IV bolus every 2 weeks 5-FU continuous infusion 2400 mg/m2, 46-hour cont. IV infusion every 2 weeks
16140008|NCT01858662|Drug|leucovorin L|Leucovorin L (levoleucovorin) 200 mg/m2 (or folinic acid 400 mg/m²) in 250 ml glucose 5%, 2-hour IV infusion
16140009|NCT01858662|Drug|Oxaliplatin|Oxaliplatin 85 mg/m² in 150 ml NaCl 0.9%, 2-hour IV infusion every 2 weeks
16140010|NCT01858662|Drug|Irinotecan|Irinotecan 180 mg/m² in 150 ml NaCl 0.9%, 1.30-hour IV infusion every 2 weeks
16140011|NCT01858662|Drug|Cetuximab|Cetuximab 400 mg/m² in 100 ml NaCl 0.9% 2-hour IV infusion for 1rst cycle and after the 1rst cycle 250 mg/m² in 100 ml NaCl 0.9% 1-hour IV infusion
16140012|NCT01858649|Procedure|Metastases resection|Surgery of colorectal cancer metastases will be proceeded after 3 to 6 cycles of chemotherapy ( folfox or folfiri) + bevacizumab .
16140065|NCT01858298|Other|Non-conservative treatment: Tooth extraction|
16140024|NCT01858584|Drug|Gastrotuss|"Gastrotuss baby: syrup based on alginate consisting of: magnesium alginate, simethicone, fructose, xanthan gum, honey, D-panthenol, fluid extracts of Althaea officinalis, Papaver rhoeas, zinc oxide, sodium bicarbonate, sodium hydroxide, p-hydroxybenzoate of methyl-sodium, sodium propyl p-hydroxybenzoate, natural flavors, erythrosine (E127), purified water.
~dosage:
~Infants weighing <5 kg in 2.5 ml 5-10 min after feeding. In case of regurgitation after administration, 1 ml additional
~Infants weighing> 5 kg per 5 ml dose after the meal and the evening before putting the baby to sleep The administration should be maximum 3 times per day"
16140025|NCT01858584|Dietary Supplement|thickened milk|Milk thickened (formulat AR): contains a special thickener derived from corn starch waxy, that maintains its fluidity into the bottle and thickens just inside the stomach of the child, and this makes it easy to use in breastfeeding , as it is usable with a common teat.
16140026|NCT01858571|Drug|Low dose chemotherapy|"Metronomic chemotherapy schedule : Alternating cycles of Cycle A and B (Each cycle includes 3 weeks of drug administration) with each drug rounded off to the nearest tablet/capsule size.
~Cycle A
~Daily oral Thalidomide (at 3mg/kg)
~Daily oral Celecoxib (100 mg BID for patients < 20 kg, 200 mg BID for patients 20-50 kg, and 400 mg BID for patients > 50 kg)
~Daily oral Etoposide (50 mg/m2/d)
~Cycle B
~Daily oral Thalidomide (at 3mg/kg)
~Daily oral Celecoxib (100 mg BID for patients < 20 kg, 200 mg BID for patients 20-50 kg, and 400 mg BID for patients > 50 kg)
~Daily oral Cyclophosphamide (2.5 mg/kg/d to a maximum of 100 mg/d) every 21 days"
16140027|NCT01858558|Biological|aMIL|On day 0, patients will receive auto transplant followed by Tadalafil and aMIL. At day 60, patients will receive Lenalidomide.
16140028|NCT01858558|Drug|No aMIL|On day 0, patients will receive auto transplant followed by Tadalafil. At day 60, patients will receive Lenalidomide.
16140029|NCT01858545|Device|MatriStem|MatriStem MicroMatrix and MatriStem Wound Matrix
16140030|NCT01858545|Device|Cellular Dermal Replacement Tissue|Cellular Dermal Replacement Tissue
16140031|NCT01858532|Drug|Atrasentan|Film-coated tablet
16140032|NCT01858532|Drug|Placebo|Film-coated tablet
16140033|NCT01858506|Procedure|I-ACE intervention|lifestyle counselling using the interactive assessment, counselling and education (I-ACE)-based method.
16140034|NCT01858506|Procedure|Standard Lifestyle Advice|lifestyle counselling using the standard lifestyle advice (SLA) program currently provided to Clalit Health Services patients.
16140035|NCT01858493|Behavioral|Continence promotion group education workshop|Interactive group education workshop promoting continence
16140036|NCT01858493|Behavioral|Sham health lecture|Interactive group education workshop about general health
16140037|NCT01858480|Drug|D-ribose|D-ribose powder for oral solution and D-ribose for injection.
16140038|NCT01858480|Other|Placebo|Placebo dosage form designed to mock active.
16140039|NCT01858467|Device|Endotracheal intubation|Portex endotracheal tube 6.5mm or 7.0mm internal diameter
16140040|NCT01858467|Device|Supreme Laryngeal Mask Airway|Supreme Laryngeal Mask Airway Size 3 or Size 4 with gastric tube insertion.
16140041|NCT01858454|Procedure|HALS|In HALS, a trocar of 5-mm calipers was inserted through the umbilicus. Next, suprapubic transverse skin incision of 3-4cm in length was made and a wound retractor (Alexis; Applied Medical, Rancho Santa Margarita, CA) was inserted through the suprapubic opening.
16140042|NCT01858454|Procedure|Open surgery|In open surgery, the patient was placed in the supine position and the operation was carried out in a standard manner as described elsewhere [Luciano AA. Myomectomy. Clin Obstet Gynecol 2009;52:362-71.].
16140043|NCT01858441|Drug|Abiraterone Acetate|
16140044|NCT01858428|Device|Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter|The CVI Paclitaxel-coated PTA Catheter is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA) coated with paclitaxel using a proprietary carrier.
16140045|NCT01858428|Device|EverCross Percutaneous Transluminal Balloon Catheter|The control device is a commercially available PTA balloon catheter (EverCross™ 0.035 PTA Balloon Catheter, Covidien, Plymouth, MN 55441, USA).
16140046|NCT01858415|Device|TriPollar|
16140047|NCT01858402|Drug|Paracetamol|15 mg/kg IV (premixed with 0.9% sodium chloride to a total of 50 ml), preoperative single dose
16140048|NCT01858402|Drug|Dipyrone|15 mg/kg IV (premixed with 0.9% sodium chloride to a total of 50 ml), preoperative single dose
16140049|NCT01858389|Drug|Dacomitinib|Dacomitinib 45 mg every 12 hours Days 1-4 of the first week, and then 60 mg every 12 hours Days 1-4 of each 2-week cycle thereafter. The dose of dacomitinib for patients in Cohort A may be further escalated in increments of 15 mg.
16140050|NCT01858389|Drug|Dacomitinib|Dacomitinib 45 mg every 12 hours Days 1-4 of the first week, and then 60 mg every 12 hours Days 1-4 of each 2-week cycle thereafter.
16140051|NCT01858376|Dietary Supplement|Capros dietary supplement|Study participants will have 2 to 3 baseline blood draws, 3 blood draws while taking Capros supplements and 2 wash out blood draws after finishing 12 weeks of Capros supplementation. Participants will attend 7 to 8 study visits (depending on number of baseline visits needed) and at each visit participants will have their blood drawn as well as height, weight, blood pressure, and pulse measured.
16140052|NCT01858363|Device|CVI Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter|
16140053|NCT01858363|Device|Bare Percutaneous Transluminal Angioplasty Balloon Catheter|
16140054|NCT01858350|Other|Active Music Therapy|
16140055|NCT01858350|Other|Passive Music Therapy|
16140056|NCT01858350|Other|Distraction Therapy|
16140057|NCT01858337|Other|green beans group|Infants were weaned with vegetable purees for the first 18 days of weaning. One vegetable type per day. With green beans every other day.
16140058|NCT01858337|Other|Artichoke group|Infants were weaned with vegetable purees for the first 18 days of weaning. One vegetable type per day. With artichoke every other day.
16140059|NCT01858337|Other|Apple group|Infants were weaned with fruit purees for the first 18 days of weaning. One fruit type per day. With apple every other day.
16140060|NCT01858337|Other|Plums group|Infants were weaned with fruit purees for the first 18 days of weaning. One fruit type per day. With Plums every other day.
16140061|NCT01858324|Other|Educational tools|Subjects will receive the educational tools. They will then receive one month after a questionnaire about knowledge, anxiety and satisfaction.
16140062|NCT01858311|Dietary Supplement|Tocotrienol Capsules|Vitamin E TCT capsules- 400mg to 800mg per day (2 in the morning and 2 in the evening)
16140069|NCT01858233|Behavioral|Intensive Behavioral Modification|Intensive dietary counseling, increased physical activity, lactation counseling
16140070|NCT01858207|Procedure|Transcatheter Arterial Chemoembolization|traditional TACE, conventional TACE
16140071|NCT01858207|Procedure|Radiofrequency ablation|simultaneous multiple electrodes and switching RF controller
16140072|NCT01858207|Drug|Doxorubicin|TACE will be done according to the current method in our center. We use intra-injection of lipiodol mized with doxorubicin when the catheter was placed in the superselective location very close to the tumor. Gelfoam sponge was then injected to temporarily occlude the arterial blood flow.
16140073|NCT01858194|Device|Renal sympathetic denervation|"The ablation catheter is placed within a long vascular sheath and advanced into the renal artery. The sheath is advanced over the catheter to engage the renal artery ostium and allow for contrast injection and visualization of the vessel during catheter manipulation.
~After completion of the measurement, no more than six radiofrequency ablation lesions separated both longitudinally and rotationally (a spiral pattern, see figure) will be placed per renal artery. The power will be started at 10 W and titrated to a maximum 20 W, as deemed appropriate by the impedance drop (goal 10% drop). Each lesion should be between 30-120 seconds in duration (no more than 120 seconds per lesion)."
16140074|NCT01858194|Device|VT ablation alone|Placebo arm will receive standard VT ablation using current techniques
16140075|NCT01858181|Biological|ocaratuzumab|
16140079|NCT01858155|Drug|Melatonin|
16140080|NCT01858142|Behavioral|Parental presence decision tool|
16140081|NCT01858142|Behavioral|Standard preparation|
16140082|NCT01858129|Drug|Experimental group: Budicort by Inhalation|Inhaled Budicort twice daily
16140083|NCT01858129|Drug|placebo|
16140084|NCT01858116|Drug|[68Ga]ABY-025|Intravenous injection followed by PET imaging
16140085|NCT01858103|Drug|BMN 110|
16140086|NCT01858090|Drug|Control Group Chirocaine|Control group: Spinal anesthesia with levobupivacaine+Serum Physiologic %0.9 (Total volume 3 mL)
16140087|NCT01858090|Drug|Group Fentanyl|
16140088|NCT01858090|Drug|Group sufentanil|
16140089|NCT01858090|Drug|Ephedrine|If systolic blood pressure values decreased more than 20% with respect to the baseline values, or decreased to <100 mmHg, fluid loading and ephedrine (5 mg) were administered.
16140090|NCT01858090|Drug|Atropine sulfate|A decrease in heart rate to less than 55 beats/min was considered as bradycardia, and atropine (0.5 mg) was administered
16140091|NCT01858090|Drug|Propofol|Intravenous propofol (up to 0.5 mg/kg) was administered if patients had discomfort
16140092|NCT01858090|Drug|Metoclopramide|Metoclopramide (10 mg IV) was administered for nausea
16140093|NCT01858090|Drug|Diphenhydramine|for severe pruritus
16140094|NCT01858090|Drug|pethidine hydrochloride|pethidine hydrochloride (50 mg IM) was administered as the first analgesic postoperatively
16140095|NCT01858090|Drug|Diclofenac sodium|as additional analgesic among cases in which VAS>3(Postoperatively)
16140096|NCT01858077|Device|ABSORB BVS™|Bioresorbable scaffold
16140097|NCT01858077|Device|XIENCE™|Drug eluting metallic stent
16140098|NCT01858064|Drug|OROS-MPH|Capsule administered daily, beginning at 36 mg/day and titrated on a weekly basis for 3 weeks in increments of 18-36 mg/day to a maximum daily dose of 90 mg/day.
16140099|NCT01858051|Dietary Supplement|Cholecalciferol|
16140100|NCT01858051|Dietary Supplement|Placebo|
16140101|NCT01858038|Device|Fraxel Repair - Fractional Laser treatment|An FDA-approved Fractional 10,600 nm laser source will be used for laser exposures performed 2 months prior to biopsies of treated sites
16140102|NCT01858025|Radiation|Pencil Beam scanning Radiation|
16140103|NCT01858025|Drug|5-fluorouracil|
16140104|NCT01858025|Drug|Mitomycin-C|
16140105|NCT01858012|Behavioral|Moderate alcohol cessation|patients will have moderate alcohol use discontinued for 6 weeks and have before and after alcohol cessation clinical and metabolic assessment and also patients with hepatitis C who have undergo therapy for hepatitis C may have repeat clinical and metabolic assessement
16140106|NCT01857999|Drug|Losartan|
16140107|NCT01857999|Drug|Placebo|
16140108|NCT01857986|Device|AnapnoGuard 100 control unit|
16140109|NCT01857973|Device|Hybrid Closed Loop|The Hybrid Closed Loop System is an investigational device intended for closed loop control of blood glucose.
16140110|NCT01857960|Behavioral|Survey|A survey is directly applied to subjects who meet the inclusion and exclusion criteria
16140111|NCT01857947|Other|AECOPD Mr proADM|
16140112|NCT01857934|Drug|cyclophosphamide|Given intravenously (IV)
16140113|NCT01857934|Drug|topotecan|Given IV
16140114|NCT01857934|Biological|hu14.18K322A|Given IV
16140115|NCT01857934|Procedure|peripheral blood stem cell harvest|Following evaluation and approval by a member of the transplant staff and completion of the consent form by the participant, collection of peripheral blood stem cells (PBSC) may take place.
16140116|NCT01857934|Procedure|surgical resection|The primary tumor will be resected surgically following two initial courses of chemotherapy, if feasible. Patients who are unable to have their primary tumor resected after the initial two courses of induction chemotherapy will undergo surgery for resection of the primary tumor mass and careful lymph node staging.
16140117|NCT01857934|Drug|cisplatin|Given IV
16140118|NCT01857934|Drug|etoposide|Given IV
16140119|NCT01857934|Drug|doxorubicin|Given IV
16140120|NCT01857934|Drug|vincristine|Given IV
16140121|NCT01857934|Drug|busulfan|Given IV
16140122|NCT01857934|Drug|melphalan|Given IV
16140123|NCT01857934|Biological|peripheral blood stem cell transplantation|Transplantation of previously harvested peripheral blood stem cells.
16140124|NCT01857934|Biological|natural killer cell infusion|Natural killer (NK) cells obtained from a suitable donor will be given together with hu14.18K322A prior to early hematopoietic cell recovery. In the event there is not a suitable parental donor, consenting participants will receive an additional course of hu14.18K322A.
16140196|NCT01857349|Other|Chlora Prep|Surgical Scrub skin preparation
16140125|NCT01857934|Radiation|radiation therapy|Radiation therapy to the primary and metastatic disease sites will follow peripheral blood stem cell transplant with the exception of any patient requiring emergent radiotherapy. External beam radiotherapy will be delivered to the primary site and select metastatic and bulky nodal sites.
16140126|NCT01857934|Biological|GM-CSF|Given subcutaneously (SQ)
16140127|NCT01857934|Biological|G-CSF|Given subcutaneously (SQ)
16140128|NCT01857934|Drug|mesna|Given IV
16140129|NCT01857934|Drug|levetiracetam|Given IV
16140130|NCT01857934|Biological|interleukin-2|Given by continuous infusion during MRD maintenance, and SQ during induction.
16140131|NCT01857934|Drug|Isotretinoin|Given orally (PO)
16140132|NCT01857934|Device|CliniMACS|The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells.
16140133|NCT01857921|Drug|Pravastatin 20mg/day for 12 months after randomization|"Patients with mono antiplatelet therapy with aspirin who had had received CABG previously fulfilling all enrollment criteria will be randomly assigned to the type of two groups. Randomization of statin therapy will be done 1:1 to one of two different groups on the web-based program:
~Test group:
~Atorvastatin 40 mg and trimetazidine MR 70 mg daily for 12 months after randomization
~Control group:
~Pravastatin 20mg daily for 12 months after randomization"
16140134|NCT01857921|Drug|Atorvastatin 40 mg and trimetazidine MR 70 mg/day for 12 months after randomization|"Patients with mono antiplatelet therapy with aspirin who had had received CABG previously fulfilling all enrollment criteria will be randomly assigned to the type of two groups. Randomization of statin therapy will be done 1:1 to one of two different groups on the web-based program:
~Test group:
~Atorvastatin 40 mg and trimetazidine MR 70 mg daily for 12 months after randomization
~Control group:
~Pravastatin 20mg daily for 12 months after randomization"
16140135|NCT01857895|Drug|Exenatide|Prefilled pen containing 2.4 mL of drug will be transferred into MiniMed Paradigm Real-Time Revel device for subcutaneous infusion.
16140136|NCT01857882|Other|Decision Support Workshop|"Incorporates the key components of shared decision-making and decision support with the philosophy of delivering supportive care to cancer patients.
~Surgeon (30 mins): treatment options for breast reconstruction with indications/ contraindications, advantages / disadvantages, expected post-operative course, aesthetic result and complications with probabilities
~Registered nurse (30 mins): preparing for surgery, postoperative recovery and how to navigate the health care system
~Social worker (30 mins): values clarification exercise
~Breast reconstruction patient volunteer (30 mins) questions and answers about her personal experience"
16140137|NCT01857869|Biological|GSK257049 Dosage 1|RTS,S/AS01B administered as 0.5 mL dose at 0 and 1 months and 0.1 mL dose at 7 months for 0,1,7 M Group (delayed fractional dose group). In subjects unprotected in the first challenge, to receive a booster with a fractional dose of RTS,S/AS01B followed by rechallenge. In subjects protected in the first challenge, randomization to receive or not receive a booster with a fractional dose of RTS,S/AS01B followed by rechallenge.
16140138|NCT01857869|Biological|GSK257049 Dosage 2|RTS,S/AS01B administered as three doses of 0.5mL given one month apart (0, 1, 2 M group) in the challenge model. In subjects unprotected in the first challenge, to receive a booster with a fractional dose of RTS,S/AS01B followed by rechallenge. In subjects protected in the first challenge, randomization to receive or not receive a booster with a fractional dose of RTS,S/AS01B followed by rechallenge.
16140139|NCT01857869|Procedure|Sporozoite-infected mosquitoes challenge|"Mosquitoes infected approximately 2-3 weeks earlier that are likely to contain sporozoites in their salivary glands will be allowed to feed on the volunteers. For each volunteer, five mosquitoes will be allowed to feed over five minutes, after which they will be dissected to confirm how many were infected, and the salivary glands scored.
~The challenge is scheduled to occur approximately 21 days (3 weeks) after the last vaccination visit (Study Day 196). Volunteers who reconsent for the boost/rechallenge phase will be rechallenged with sporozoite-infected mosquitoes, scheduled to occur approximately 21 days (3 weeks) after the booster dose (Booster Phase Study Day 21)."
16140141|NCT01857843|Device|Zotalolimus Eluting Stent|"Permuted block randomization into 4 groups according to the type of drug and stent will be carried out in a ratio of 1:1:1:1(i.e.,Vytorin-ZES, Vytorin-EES, mevalotin-ZES, or mevalotin-EES) for balanced randomization.
~Patients with native coronary arteries who fulfill all enrollment criteria for OCT study will be randomized to receive either ZES (Endeavor®-Sprint or Resolute-integrity) or EES (Xience®) in a ratio of 1:1."
16140142|NCT01857843|Device|Everolimus eluting stent|"Permuted block randomization into 4 groups according to the type of drug and stent will be carried out in a ratio of 1:1:1:1(i.e.,Vytorin-ZES, Vytorin-EES, mevalotin-ZES, or mevalotin-EES) for balanced randomization.
~Patients with native coronary arteries who fulfill all enrollment criteria for OCT study will be randomized to receive either ZES (Endeavor®-Sprint or resolute-integrity) or EES (Xience®) in a ratio of 1:1."
16140143|NCT01857843|Drug|Ezetimibe 10mg & Simvastatin 40mg|"Permuted block randomization into 4 groups according to the type of drug and stent will be carried out in a ratio of 1:1:1:1(i.e.,Vytorin-ZES, Vytorin-EES, mevalotin-ZES, or mevalotin-EES) for balanced randomization.
~Patients will be randomized in a ratio of 1:1 according to the two different types of lipid lowering treatment.
~Ezetimibe 10mg/Simvastatin 40mg (Vytorin®, MSD)
~Pravastatin 20mg (mevalotin®, BMS)"
16140144|NCT01857843|Drug|Pravastatin 20mg|"Permuted block randomization into 4 groups according to the type of drug and stent will be carried out in a ratio of 1:1:1:1(i.e.,Vytorin-ZES, Vytorin-EES, mevalotin-ZES, or mevalotin-EES) for balanced randomization.
~Patients will be randomized in a ratio of 1:1 according to the two different types of lipid lowering treatment.
~Ezetimibe 10mg/Simvastatin 40mg (Vytorin®, MSD)
~Pravastatin 20mg (mevalotin®, BMS)"
16140145|NCT01857830|Behavioral|Meditation Retreat|The intervention is a one week meditation and yoga retreat hosted at the La Costa Resort and Spa in Carlsbad, CA.
16140146|NCT01857830|Behavioral|Active Comparator Relaxation Group|Participants are randomized to stay at La Costa Resort and Spa for 6 days. Participants will receive daily meals similar to the meals for those in the retreat group. Participants will also receive a daily one hour lecture on topics related to longevity and health.
16140197|NCT01857349|Other|Dura Prep|Surgical Scrub skin preparation
16140147|NCT01857817|Drug|VT-122|The following will be used in the study for VT-122: propranolol 22 mg immediate-release capsules and etodolac 340 mg capsules.
16140148|NCT01857817|Drug|Placebo|The placebo capsules will be prepared to match the active drug.
16140149|NCT01857804|Drug|Amoxicillin|In the test group a systemic antibiotic regimen will be initiated at 3 days before surgery and continued for 10 days. (2 x 750mg amoxicillin/day or 2 x 1g amoxicillin/day depending on the weight of the patient)
16140150|NCT01857804|Drug|Chlorhexidine gluconate|The exposed implant surfaces will be cleaned 3 minutes with antiseptics (chlorhexidine gluconate 0,2%) during the surgical treatment
16140151|NCT01857804|Drug|Saline|The exposed implant surfaces will be cleaned 3 minutes with saline during the surgical treatment
16140152|NCT01857791|Behavioral|multidisciplinary, behavior modification|
16140153|NCT01857765|Behavioral|Rehabilitation|Range of motion stretching exercises
16140154|NCT01857765|Behavioral|Follow-up|Follow-up with surgeon's clinic
16140155|NCT01857752|Drug|Temozolomide|
16140156|NCT01857726|Drug|Doxorubicin|Transarterial chemoembolization (TACE) with adriamycin
16140157|NCT01857726|Drug|Cisplatin|transarterial chemoinfusion with cisplatin 50-100 mg
16140158|NCT01857713|Device|Reza Band UES Assist Device|Device is worn by patient to reduce or eliminate laryngopharyngeal reflux
16140159|NCT01857700|Other|Compensation for transport cost|
16140160|NCT01857700|Other|Compensation for lost wages|
16140161|NCT01857700|Other|Compensation for transport cost and lost wages|
16140162|NCT01857700|Other|Standard of Care|Consistent with standard of care, participants in this group will be offered a refreshment during their office visit.
16140163|NCT01857661|Device|sound generator|hearing aid with an integrated sound generator
16140164|NCT01857661|Device|hearing aids with only amplification|
16140165|NCT01857648|Other|Physical activity counseling|Home visits including physical activity promotion by the trained Community Health Workers.
16140166|NCT01857622|Drug|DU-176b 15mg|oral DU-176b 15mg once daily
16140167|NCT01857622|Drug|DU-176b 30mg|oral DU-176b 30mg once daily
16140168|NCT01857622|Drug|DU-176b 60mg|oral DU-176b 60mg once daily
16140169|NCT01857609|Drug|Metformin|
16140170|NCT01857609|Drug|Metformin and Pantoprazole|
16140171|NCT01857609|Drug|Metformin and Rabeprazole|
16140172|NCT01857596|Drug|bupropion, Lorexys low-dose, Lorexys moderate-dose|Lorexys is a proprietary fixed-dose combination of two agents
16140173|NCT01857583|Drug|15mg DU-176b|
16140174|NCT01857583|Drug|30mg DU-176b|
16140175|NCT01857583|Drug|Fondaparinux|
16140176|NCT01857570|Radiation|Volume Computed Tomography of the wrist and carpus|
16140177|NCT01857557|Other|Aerobic exercise|Patients receiving exercise program in addition to usual headache care
16140178|NCT01857544|Drug|Aflibercept|Monthly 2.0mg Aflibercept Intravitreal Injection
16140179|NCT01857531|Drug|Ganaxolone|"Pre-Quit Period:
~Beginning at Session P1, subjects will receive ganaxolone at a dose of 400mg total daily (200mg bid) for the first three days, 800mg total daily (400mg bid) for the next three days and 1200mg total daily (600mg bid) for the remainder of the first four weeks.
~Post-Quit Period:
~Following the quit-day, subjects will receive ganaxolone at a dose of (1200mg total daily) for the next week. Down-titration of ganaxolone will begin at post-quit week two. Subjects will receive ganaxolone at a dose of 800mg total daily (400mg bid) to take for three days and 400mg total daily (200mg bid) to take for three."
16140180|NCT01857531|Drug|Nicotine Patch|"Pre-Quit Period:
~Beginning at Session P2, subjects will receive active 21mg/24h nicotine patches to apply daily for the next two weeks.
~Post-Quit Period:
~Following the quit-day, subjects will continue to apply active nicotine patches daily for the remainder of the study (21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week)."
16140181|NCT01857518|Other|-Diagnostic, clinical and psycho-behavioral assessments -Neuroimaging: T1-MRI, DTI-MRI, fMRI|"Visit V1: Diagnostic and clinical assessments
~Visit V2: psycho-behavioral assessment and neuroimaging
~Visit V3: Diagnostic and clinical assessments
~Visit V4: psycho-behavioral assessment and neuroimaging"
16140182|NCT01857492|Device|tDCS|
16140183|NCT01857492|Behavioral|Meditation|Both Active and SHAM groups will receive Meditation.
16140184|NCT01857479|Drug|Inhaled budesonide|The control group will receive only nebulized budesonide 1 mg b.i.d. thrice a week for four months. Patients will also receive a metered dose inhaler of formoterol/budesonide (6/200) at a dose of 2 puffs b.i.d. and as and when required [max 10 puff/day]. The first dose will be administered under direct supervision. If the first dose is tolerated, therapy would be continued for the total duration of the study (4 months). The patient will be advised to clean the nebulizer chamber with soap and water after each administration to avoid contamination.
16140185|NCT01857479|Drug|Inhaled amphotericin|"Amphotericin B deoxycholate (50 mg) will be dissolved in 10 mL sterile water for injection (5 mg/mL). The solution remains stable for at least 7 days at 2°C to 8°C. Ten milligrams of the drug (2 mL) will be nebulized over 10-15 minutes twice in a day for three times a week (Effective dose: 10 mg b.i.d. thrice a week) using a jet nebulizer. Nebulized budesonide will be administered at a dose of 1 mg b.i.d. thrice a week after nebulization with amphotericin B. The total duration of therapy would last 4 months. Patients will also receive a metered dose inhaler of formoterol/budesonide (6/200) at a dose of 2 puffs b.i.d. and as and when required [max 10 puff/day].
~The first dose will be administered under direct supervision."
16140186|NCT01857466|Procedure|Floseal|
16140187|NCT01857466|Procedure|Bipolar coagulation|
16140188|NCT01857453|Drug|carboplatine|carboplatine + etoposide based chemotherapy followed by radiation therapy with 24 Gy on the in toto neuro axis and 54 Gy on the post operative bed
16140189|NCT01857453|Drug|Etoposide|carboplatine + etoposide based chemotherapy followed by radiation therapy with 24 Gy on the in toto neuro axis and 54 Gy on the post operative bed
16140190|NCT01857453|Radiation|radiation therapy|carboplatine + etoposide based chemotherapy followed by radiation therapy with 24 Gy on the in toto neuro axis and 54 Gy on the post operative bed
16140191|NCT01857401|Other|No intervention, observational study only|No intervention. We are collecting blood for an ex vivo study
16140192|NCT01857388|Behavioral|ParentCorps|
16140193|NCT01857375|Device|Insulin Pen Device|Insulin pen was compared to administration of insulin using standard syringes.
16140194|NCT01857362|Drug|Nitisinone 20 mg|Nitisinone 20 mg capsules
16140198|NCT01857336|Other|infusion of G-CSF mobilized peripheral harvest|
16140199|NCT01857323|Drug|Albuterol Spiromax®|Albuterol Spiromax delivers 90 mcg of albuterol base from the mouthpiece per triggered dose. Participants took doses of 2 inhalations each twice a day (morning and evening) for a total daily dose of 360 mcg. The first 45 enrolled participants constituted a subgroup who were dosed for 35 days, while most participants were dosed for 50 days.
16140200|NCT01857310|Dietary Supplement|5 mg folic acid and 30 mg elemental zinc|
16140201|NCT01857310|Drug|Placebo Comparator: Placebo|
16140202|NCT01857297|Biological|Enzira® vaccine|
16140203|NCT01857284|Drug|Tauroursodeoxycholic Acid Capsules|250mg.tid.po
16140204|NCT01857284|Drug|Ursodeoxycholic Acid Capsules|250mg.tid.po
16140205|NCT01857271|Drug|Erlotinib Hydrochloride|Given PO
16140206|NCT01857271|Procedure|Therapeutic Conventional Surgery|Undergo thoracotomy
16140207|NCT01857271|Other|Laboratory Biomarker Analysis|Correlative studies
16140208|NCT01857258|Dietary Supplement|Green Tea Concentrate|Green tea concentrate is being examined as a dietary supplement that can regulate postprandial excursions in blood glucose
16140209|NCT01857245|Other|Intensive Models (mDOT and CGT) of HCV Care|Modified Directly Observed therapy (mDOT) and concurrent group treatment (CGT) are on-site HCV treatment models.
16140210|NCT01857232|Drug|Ondansetron|5HT3-antagonist
16140211|NCT01857232|Drug|Placebo|Comparator
16140212|NCT01857232|Drug|Dexamethasone|Corticosteroid
16140213|NCT01857232|Drug|Fosaprepitant|NK1 antagonist
16140214|NCT01857232|Drug|APD403 IV|Amisulpride IV 20 mg
16140215|NCT01857232|Drug|APD403 oral|Amisulpride oral 10, 20 or 40 mg
16140216|NCT01857219|Behavioral|Tai chi|
16140217|NCT01857206|Biological|Mammalian cell based flu vaccine|
16140218|NCT01857206|Biological|Egg based flu vaccine|
16140219|NCT01857193|Drug|ribociclib (LEE011)|LEE011 is taken orally once per day for 21 days of each 28 day cycle. LEE011 comes in 50 mg and 200 mg capsules.
16140220|NCT01857193|Drug|Exemestane|Exemestane is taken orally once per day. Exemestane comes in 25 mg tablets.
16140221|NCT01857193|Drug|Everolimus (RAD001)|Everolimus is taken orally once per day. Everolimus comes in 1 mg, 2.5 mg, 5mg, and 7.5 mg tablets
16140222|NCT01857180|Other|Curriculum|
16140223|NCT01857167|Dietary Supplement|Fish Oil Supplementation|
16140224|NCT01857167|Dietary Supplement|Flaxseed Oil Supplementation|
16140225|NCT01857167|Dietary Supplement|placebo|
16140226|NCT01857154|Dietary Supplement|Micronized Calcium Carbonate|"Subjects currently being treated with bisphosphonates will be administered 500 mg micronized calcium carbonate.
~Subjects not currently being treated with bisphosphonates will be administered 500 mg micronized calcium carbonate."
16140227|NCT01857154|Dietary Supplement|Non-Micronized Calcium Carbonate|"Subjects currently being treated with bisphosphonates will be administered 1000 mg non-micronized calcium carbonate.
~Subjects not currently being treated with bisphosphonates will be administered 1000 mg non- micronized calcium carbonate."
16140228|NCT01857154|Dietary Supplement|Vitamin D3|All subjects in the study cohort will be administered 800 IU Vitamin D3.
16140229|NCT01857141|Drug|preemptive dexmedetomidine epidural bolus injection(1.5 mcg/kg)|Patients in the pre-emptive groups recived a dose of 1.5㎍/kg dexmedetomidine dissolved into normal saline 10cc before the induction of
16140230|NCT01857141|Drug|normal saline|patients in the control groups received the equivalent volume of normal saline.
16140231|NCT01857128|Device|Drawtex dressing|
16140232|NCT01857128|Device|Negative Pressure Wound Therapy|
16140233|NCT01857115|Drug|Carfilzomib|
16140234|NCT01857115|Drug|Cyclophosphamide|
16140235|NCT01857115|Drug|Dexamethasone|
16140236|NCT01857102|Device|etafilcon A|Soft contact lens to be worn in a daily wear, daily disposable modality for one week
16140237|NCT01857102|Device|etafilcon A for Astigmatism|Soft contact lens to be worn by participants in a daily wear, daily disposable modality for one week.
16140238|NCT01857089|Device|Orthotest CE|"Orthotest CE is a rigid base mapping system composed by 1024 pressure transducers uniformly distributed in a 35x35 cm surface.
~Orthotest CE is a product manufactured by Vista-Medical. The patient sit on the rigid base during 2 hours to record the pressure and all the data needed for the pilot study.
~Pressure measurement"
16140239|NCT01857076|Procedure|Gastric bypass surgery|Gastric bypass surgery performed laparoscopically
16140240|NCT01857076|Procedure|Surgical ileal transposition with sleeve|Surgical Treatment with Ileal Transposition in the duodenum and Vertical Sleeve Gastrectomy through laparoscopic surgery.
16140241|NCT01857076|Other|Clinical|The study subjects allocated for clinical treatment will have these treatment divided into three phases. The first one based on glycemic control through weight loss, the second one based on anti-hyperglycemic medications and the last one based on medical monitoring for a further twelve months for the maintenance of the results.
16140242|NCT01857063|Drug|Montelukast|Montelukast 5 mg chewable tablets, taken orally once daily at bedtime for 7 days
16140243|NCT01857063|Drug|Placebo|Matching placebo chewable tablets, taken orally once daily at bedtime for 7 days
16140244|NCT01857037|Other|Histoscanning™ and multiparametric MRI|Detection and localization of prostate cancer local recurrences after radiation therapy using Histoscanning™ and multiparametric MRI
16140245|NCT01857024|Drug|sevelamer carbonate (Renvela®)|800 mg tablets or 2.4 g powder for oral suspension should be administered as instructed in the Renvela® SmPC.
16140246|NCT01857011|Drug|Intravenous Iron sucrose|Intravenous Iron Sucrose 200 mg in the immediate postoperative period and first day postop.
16140247|NCT01857011|Drug|Oral Iron|Oral iron(III)-hydroxide polymaltose complex 100 mg twice daily in the fist 8 postoperative weeks.
16140248|NCT01856998|Drug|Propofol|
16140249|NCT01856998|Drug|Diprivan|
16140250|NCT01856985|Drug|Misoprostol|
16140251|NCT01856985|Drug|Mifepristone|
16140326|NCT01856374|Device|Sirolimus-eluting stent (Cypher SelectTM, Cordis, Miami, FL)|Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; Xience Prime® vs. Cypher SelectTM and pravastatin 20mg vs. atorvastatin 40mg.
16140459|NCT01855451|Radiation|RT (70 Gy in 35 fractions)|
16140460|NCT01855451|Drug|Cisplatin|
16140252|NCT01856972|Procedure|Instrument Assisted Soft Tissue Mobilization|IASTM treatment: will be performed with the sound assisted soft tissue mobilization tool #5. Patient will be placed in the prone position with the ankle in a relaxed position. The treating therapist will perform 10 scanning strokes in the caudal, cephalic, medial, lateral directions for a total of 40 strokes over the Gastrocnemius/Soleus complex. The therapist can then perform more concentrated strokes in areas noted by the therapist as tight, with a maximum treatment time of 5 minutes.
16140253|NCT01856972|Procedure|Rearfoot joint mobilization|A high velocity-low amplitude distractive thrust is directed at the talocrural joint. The procedure is performed with the patient in the supine position. The therapist interlaces hands over the dorsum of the foot with 5th digit placed on talus. The therapist slightly pronates and dorsiflexes the foot. Tension is taken up in a caudal direction until the soft tissue barrier is engaged. A distractive thrust is then applied. This is performed up to 2 times. If the therapist notes a cavitation, the patient is progressed to ROM exercises. If there is no cavitation is noted by the therapist the thrust mobilization is reapplied.
16140254|NCT01856972|Other|Static stretching/ROM exercises|Gastrocnemius stretch at wall 3 sets of 30 second holds. Soleus stretch at wall 3 sets of 30 second holds. Standing bilateral dorsiflexion on step x30 with full ROM. Standing bilateral plantar flexion on step x30 with full ROM.
16140255|NCT01856959|Drug|Magnesium Sulfate|2ml of 7.5% solution of isotonic magnesium heptahydrate, 150 mg
16140256|NCT01856959|Drug|magnesium sulfate & albuterol|0.5ml of albuterol mixed with 2ml of isotonic magnesium sulfate,150mg+2.5mg
16140257|NCT01856959|Drug|Albuterol|0.5ml of albuterol mixed with 1.5cc of normal saline, 2.5 mg
16140258|NCT01856946|Dietary Supplement|4,000 IU vitamin D3|two 2,000 IU vitamin D3 pills (total 4,000 IU) daily for six months.
16140259|NCT01856933|Drug|PSMA ADC|2.5 mg/kg, IV, over 60 minutes every 3 weeks
16140260|NCT01856920|Biological|GI-6207 [Recombinant Saccharomyces cerevisiae-CEA (610D)]|GI-6207 is a heat-killed, recombinant yeast-based vaccine engineered to express the full length human carcinoembryonic antigen (CEA), with a modified gene coding sequence to code for a single amino acid substitution (asparagine to aspartic acid) at the native protein amino acid position 610, which is designed to enhance immunogenicity. A plasmid vector containing the modified human CEA gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wild-type yeast) to produce the final recombinant vaccine product.
16140261|NCT01856907|Drug|Sitagliptin-Metformin|Experimental -dipeptidyl peptidase-4 (DPP-4) inhibitor- oral medication
16140262|NCT01856907|Drug|Metformin|Biguanide- insulin sensitizer
16140263|NCT01856907|Drug|Placebo pill|Will evaluate effect of lifestyle and diet only
16140264|NCT01856881|Drug|AMG 876|Ascending multiple doses of study drug administered SC
16140265|NCT01856868|Drug|(-)-epicatechin|purified nutritional extract (-)-epicatechin 100mg/day orally for 8 weeks.
16140266|NCT01856855|Radiation|Stereotactic Body Radiation Therapy with Integrated Boost|SBRT with Integrated boost at 7.25 Gy and 8.00 Gy per fraction for five fractions
16140267|NCT01856842|Procedure|Angiography and embolotherapy|
16140268|NCT01856829|Dietary Supplement|Omega-3|The capsule will be take daily for 4 weeks before and for the duration of the tests of the perceptual-cognitive training protocol. The testing period will held at intervals of 3 to 7 days for 5 sessions (maximum of 5 weeks testing). Taking products will be made more specifically 30 minutes before the start of the sessions.
16140269|NCT01856829|Other|Placebo|The capsule will be take daily for 4 weeks before and for the duration of the tests of the perceptual-cognitive training protocol. The testing period will held at intervals of 3 to 7 days for 5 sessions (maximum of 5 weeks testing). Taking products will be made more specifically 30 minutes before the start of the sessions.
16140270|NCT01856816|Other|Meal Pattern Treatment A|"In treatment A, subjects consumed 100% of salad vegetables and canola oil in the first meal and 0% in the second. Additional protein-rich chef's salad ingredients were distributed equally between meals."
16140271|NCT01856816|Other|Meal Pattern Treatment B|"In treatment B, subjects consumed 50% of salad vegetables and canola oil in the first meal and 50% in the second. Additional protein-rich chef's salad ingredients were distributed equally between meals."
16140272|NCT01856816|Other|Meal Pattern Treatment C|"In treatment C, subjects consumed 75% of vegetables and oil in the first meal and 25% in the second. Additional protein-rich chef's salad ingredients were distributed equally between meals."
16140273|NCT01856803|Drug|anti thymoglobulin|
16140274|NCT01856790|Device|ePID closed loop system|Insulin pump controlled by closed loop unit and algorithm
16140275|NCT01856790|Drug|liraglutide|Liraglutide is a long-acting analog of human glucagon like peptide-1 (GLP-1) that works as a GLP-1 receptor agonist
16140276|NCT01856777|Device|Semi-quantitative panel test|
16140277|NCT01856777|Device|High sensitivity urine pregnancy test|
16140278|NCT01856764|Drug|0.5% Roflumilast Cream|Roflumilast 0.5% cream
16140279|NCT01856764|Drug|Vehicle Cream|Roflumilast formulation vehicle
16140280|NCT01856738|Drug|Rivastigmine|Capsule. Dose 3,0 - 6,0 mg BID
16140281|NCT01856738|Drug|Placebo (for rivastigmine)|Capsule. Dose 3,0 - 6,0 mg BID
16140282|NCT01856725|Procedure|Hemodynamic measurements for CRT device programming|
16140283|NCT01856725|Device|CRT device implant with MultiPoint Pacing|
16140284|NCT01856712|Drug|Naltrexone|Naltexone was chosen for this study because naltrexone is the only medication available in both oral daily and injectable monthly formulations, which will allow the study to examine issues around medication adherence.
16140285|NCT01856686|Drug|BP22042013|This group of patients receive 2.000 kilo-calories diet (60 g. carbohydrates, 144 gr of fat and 107 gr of proteins), including 2 protein shakes.
16140286|NCT01856686|Dietary Supplement|Low carbohydrate diet|the second group of patients receive diet of 2.000 Kilo-calories without rapidly absorbed carbohydrates and without proteins supplements
16140327|NCT01856374|Device|Everolimus-eluting stent(Xience Prime®, Abbott Vascular, Santa Claea, CA)|Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; Xience Prime® vs. Cypher SelectTM and pravastatin 20mg vs. atorvastatin 40mg.
16140328|NCT01856374|Drug|Pravastatin 20mg|2x2 randomization by the treatment of dyslipidemia (In patients of dyslipidemia: pravastatin 20mg/day vs. atorvastatin 40mg and the types of the implanted cypher vs xience.
16140499|NCT01855165|Behavioral|Advice on DDIs|
16140287|NCT01856673|Behavioral|Common Elements Treatment Approach|It was developed for treating symptoms related to violent trauma, i.e. symptoms of depression, anxiety and distress, among a population victimized by violence and torture in Colombia. The most relevant components for treatment of these 3 problematic issues were identified from literature review and a panel of experts. Descriptions and schemes have been developed in order to guarantee facility of use by community counselors who have little background in mental health skills. These counselors, who will be called Lay Psychosocial Community Workers (LPCW), will receive training in this technique before beginning of interventions. Application of this technique will be supervised constantly by mental health professionals (psychologist or social worker) from the project team.
16140288|NCT01856673|Behavioral|Narrative Community Group Therapy|It consists on teaching skills to people in the community to provide mental health therapy. Therapy will be performed by LPCW under constant supervision of mental health professionals (psychologists or social workers). Sessions will begin with a series of introductory activities that motivates participants to propose different problems that they would like to solve in the group. A participant proposed a problem and he/she will be asked to talk about it. LPCW and/or psychologist will support individuals if anyone needs help to solve a psychological crisis. At the end of this narration, participants will be asked about who has had a similar situation, and how they solved it. In this way, proposed solutions will be collected by the LPCW. Finally, session closes with a motivating activity.
16140289|NCT01856673|Other|Standby group|Standby group: they will be assessed at baseline with the initial survey and they will wait between 10 and 12 weeks; an exit assessment will be performed with the study instrument. After the exit survey, control group participants will have an appointment with a professional psychologist to determine whether they require a mental health treatment. Those with such necessity will receive treatment in the ACOPLE center by professional psychologists or they will be referred to other health care level according to the type of psychopathology (e.g., psychosis) or its severity. Also, participants in the control group will be monitoring monthly by phone calls and if they have any psychological problem, they will be assessed in the ACOPLE center.
16140290|NCT01856660|Behavioral|Low-Carbohydrate Diet|Participants are provided with a 6-month standard lifestyle intervention where carbohydrate intake is limited to 50 g/day. There is no calorie restriction for participants following the Low-Carbohydrate diet. Gradual increase in physical activity across the trial to > 40 min per day, 5 times/week.
16140291|NCT01856660|Behavioral|Low-fat Diet|Participants are provided with a 6-month standard lifestyle intervention. They will follow an energy restricted, low-fat diet where the daily energy consumption target is 1,200- 1,500 kilocalories/d. The fat intake target is 28% or less of daily kilocalories. Gradual increase in physical activity until participants are active at least 40 min per day, 5 times/week.
16140292|NCT01856647|Procedure|Adipose tissue biopsy (fat biopsy)|An adipose tissue biopsy will be performed after a 10-12 hour overnight fast. A small sample of fat tissue will be removed from the subject for gene expression analysis. A subcutaneous fat biopsy (~3 ml) will be obtained from the lower abdomen following local anesthesia.
16140293|NCT01856634|Drug|100 mg Delamanid|100 mg Delamanid BID for 10 days
16140294|NCT01856634|Drug|50 mg Delamanid|50 mg Delamanid BID for 10 days
16140295|NCT01856634|Drug|25 mg Pediatric Formulation Delamanid|25 mg Pediatric Formulation Delamanid BID for 10 days
16140296|NCT01856634|Drug|10 mg Delamanid Pediatric Formulation|Patients > 10 kg will receive DPF 10 mg BID for 10 days
16140297|NCT01856634|Drug|5 mg Delamanid Pediatric Formulation|"Patients > 8 kg and ≤ 10 kg will receive DPF 5 mg BID for 10 days
~Patients ≤ 8 kg will receive DPF 5 mg QD for 10 days"
16140298|NCT01856634|Drug|Optimized Background Regimen|Selection and administration of the treatment medications (i.e. OBRs) will be based on WHO's Guidelines for the programmatic management of drug-resistant TB, in conjunction with national TB program guidelines in each country
16140299|NCT01856621|Drug|Seretide Diskus and charcoal|2 inhalations as a single dose
16140300|NCT01856621|Drug|Seretide Diskus|2 inhalations as a single dose
16140301|NCT01856621|Drug|SF Easyhaler and charcoal|2 inhalations as a single dose
16140302|NCT01856621|Drug|SF Easyhaler|2 inhalations as a single dose
16140303|NCT01856595|Drug|PF-06291874|The dosing schedule is 5, 15, 50, 100 and 150 mg QD for 14 days for the first 5 cohorts in Part A. The dosing schedule for the first cohort in Part B is 15 mg QD for 14 days and 30 mg QD for 28 days
16140304|NCT01856595|Drug|Placebo|Placebo tablets will be administered QD in each of the cohorts for 14 days (Part A cohorts 1- 5 and Part B cohort 1) or 28 days (Part B cohort 2).
16140305|NCT01856582|Biological|CD34+|CD34+ cells are selected using the CliniMACS System; without preparative regimen
16140306|NCT01856569|Other|no intervention|in real life of drug,dosage,frequency and duration
16140307|NCT01856556|Drug|NRX-1074|Single IV or PO administration
16140308|NCT01856556|Drug|Placebo|Single IV or PO placebo administration
16140309|NCT01856543|Other|Eucerin|
16140310|NCT01856543|Other|Mometasone Furoate 0.1%|
16140311|NCT01856530|Drug|Oxytocin|Liquid metered-dose nasal spray, 24 IU, administered once
16140312|NCT01856530|Drug|Placebo|Matched placebo nasal spray
16140313|NCT01856517|Drug|Clonidine|
16140314|NCT01856517|Drug|Placebo|
16140315|NCT01856491|Device|RELIANCE 4-FRONT™ Passive Fixation lead implantation|Implantation of transvenous defibrillation lead with passive fixation mechanism.
16140318|NCT01856452|Device|the mixture including indocyanine green|Sentinel lymph node biopsy using near-infrared imaging system and gamma probe detector for the mixture of indocyanine green, blue dye, and radioisotope during operation
16140319|NCT01856452|Device|radioisotope|Sentinel lymph node biopsy using gamma probe detector for radioisotope during operation
16140320|NCT01856439|Drug|ProSavin|Long term follow up of patients who received ProSavin in a previous study
16140321|NCT01856426|Drug|EDP239|
16140322|NCT01856426|Drug|Placebo|
16140323|NCT01856413|Drug|Zutectra|Subcutaneous injections of Zutectra up to 1,000 IU (2 ml) per week.
16140324|NCT01856387|Biological|high neutrophil to lymphocyte ratio|
16140325|NCT01856387|Other|normal neutrophil-to Lymphocyte ratio|
16140500|NCT01855152|Other|Optimised WHELD intervention|Experimental: Optimised WHELD intervention
16140329|NCT01856374|Drug|Atorvastatin 40mg|2x2 randomization by the treatment of dyslipidemia (In patients of dyslipidemia: pravastatin 20mg/day vs. atorvastatin 40mg and the types of the implanted cypher vs xience.
16140330|NCT01856361|Drug|Ramipril|Angiotensin Converting Enzyme Inhibitor
16140331|NCT01856361|Drug|Placebo|Placebo pill that will match the treatment pill
16140332|NCT01856348|Drug|Vitamin D|
16140333|NCT01856335|Other|Patient Education|
16140334|NCT01856335|Other|exercise: increase physical activity/goal setting|
16140335|NCT01856322|Drug|Sulindac|one tablet 150mg twice daily
16140336|NCT01856322|Drug|Placebo|One tablet twice daily
16140337|NCT01856322|Other|Validate assays and shipping methods|
16140338|NCT01856309|Drug|Sirukumab 100 mg|Sirukumab 100 mg subcutaneously (SC) at Weeks 0 (administered as the last dose in CNTO136ARA3002 or CNTO136ARA3003), 2, and every 2 weeks through Week 156 for participants who completed CNTO136ARA3002 and through Week 208 for participants who completed CNTO136ARA3003.
16140339|NCT01856309|Drug|Sirukumab 50 mg|Sirukumab 50 mg SC at Weeks 0 (administered as the last dose in CNTO136ARA3002 or CNTO136ARA3003), 4, and every 4 weeks through Week 156 for participants who completed CNTO136ARA3002 and through Week 208 for participants who completed CNTO136ARA3003.
16140340|NCT01856309|Drug|Placebo|Between sirukumab 50 mg injections, placebo SC injections will be administered at Weeks 2, 6, and every 4 weeks until the study becomes open-label, and placebo injections are discontinued.
16140341|NCT01856296|Procedure|Biopsy|
16140342|NCT01856283|Drug|Nilotinib 300mg BID|Nilotinib
16140343|NCT01856270|Drug|Amitriptyline|Participants with headache will be enrolled within the first 12 weeks after injury and will be randomly assigned to 2 groups (see Table 1 for summary of protocol). Group 1 will be assessed within 3 months of injury (baseline, Day 0) (when they will receive their initial ramp-up dosage containers; see Table 2 for dosing), Day 30 and Day 60 (to monitor compliance and distribute study drug), and for final outcome on Day 90. Group 2 will be assessed within 3 months of injury (baseline, Day 0) but will not receive medication until their Day 30 visit. Those in group 2 who report headache at Day 30 will receive their initial dosage container and will then be reassessed at Day 60 (to monitor compliance and distribute study drug) and Day 90 (final outcome).
16140344|NCT01856257|Biological|Anti-thymocyte Globulin (Rabbit)|The target dosage is 6mg/kg total over 3 to 4 days. The recommended route of administration is intravenous infusion using a high-flow vein.
16140345|NCT01856257|Biological|belatacept|Participants will receive belatacept at a dose of 10mg/kg up on day 1, 5, 14, 28, 56 and 84. After 84 days, subjects will receive a maintenance dose of 5 mg/kg every 4 weeks until completion of the trial.
16140346|NCT01856257|Drug|methylprednisolone|Methylprednisolone will be administered at a target dose of 500 mg beginning on the day of transplant, and tapered to 250 mg day 1 post-transplant, 125 mg day 2 post-transplant, 60 mg day 3 post-transplant, 30 mg day 4 post-transplant and day 5 post-transplant 0 mg if therapeutic tacrolimus level achieved for groups 1 and 3.
16140347|NCT01856257|Biological|basiliximab|Basiliximab will be administered in two doses of 20 mg each.
16140348|NCT01856257|Drug|mycophenolate mofetil|Mycophenolate Mofetil will be administered at a target dose of 1000 mg orally twice a day. Myfortic® (mycophenolate sodium) may be used as a replacement for MMF. Mycophenolate sodium will be dosed at 720 mg PO BID. Mycophenolate sodium will be adjusted based on clinical complications.
16140349|NCT01856257|Drug|tacrolimus|The site investigator will identify a starting tacrolimus dose at their discretion, in order to achieve the target trough levels, no later than 5 days post-transplantation. The dose will be adjusted to 5-8ng/ml for the active comparator arm (thymoglobulin + tacrolimus + MMF arm) or tapered off in the experimental arm (basiliximab + 20 weeks of tacrolimus + MMF + belatacept).
16140350|NCT01856244|Behavioral|treadmill walking|
16140351|NCT01856244|Device|Treadmill|
16140352|NCT01856231|Behavioral|Lifestyle physical activity - self-efficacy|Subjects will come into an exercise lab 2 days per week and perform 10-20 minutes of walking, 13 strength training exercises, stretching and a behavioral intervention including goal setting, etc.
16140353|NCT01856218|Drug|UX003|
16140354|NCT01856205|Drug|Intravenous immunoglobulin [ImmunoRel™ (batch 20081217)]|"IVIG group received 400mg/kg/day intravenous at the rate of 0.01 to 0.02 ml/kg body weight/minute for 5 days or appearance of side effect or adverse events.
~Placebo group received 0.9% saline intravenous at similar rate."
16140355|NCT01856192|Drug|Cyclophosphamide|Given IV
16140356|NCT01856192|Drug|Doxorubicin Hydrochloride|Given IV
16140357|NCT01856192|Other|Laboratory Biomarker Analysis|Correlative studies
16140358|NCT01856192|Drug|Lenalidomide|Given PO
16140359|NCT01856192|Drug|Prednisone|Given PO
16140360|NCT01856192|Biological|Rituximab|Given IV
16140361|NCT01856192|Drug|Vincristine Sulfate|Given IV
16140362|NCT01856179|Dietary Supplement|Echium oil|Oil of Echium platagineum (natural plant oil) ca. 15-18 g/d (Croda)
16140363|NCT01856166|Device|Release analgesia by CADD SMITHS PCEA pump|Analgesia will be release by continuous manner with an automatic pump
16140364|NCT01856166|Device|Release analgesia by CADD SMITHS PIEB pump|Analgesia will be release by bolus with an automatic pump
16140365|NCT01856166|Drug|Levobupivacaine|
16140366|NCT01856166|Drug|Sufentanil|
16140367|NCT01856153|Dietary Supplement|Before meal|
16140368|NCT01856153|Dietary Supplement|With Meal|
16140369|NCT01856153|Dietary Supplement|After meal|
16140370|NCT01856140|Biological|ALLO-ASC(allogeneic adipose derived mesenchymal stem cell) injection|
16140371|NCT01856127|Drug|Vilazodone|Vilazodone is a newly introduced antidepressant which, in contrast to the selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) appears to have a minimal adverse effect on sexual functioning
16140372|NCT01856127|Drug|Sertraline|Sertraline hydrochloride (trade names Zoloft, Lustral) is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class.
16140373|NCT01856114|Drug|Fentanyl Buccal Tablet|Fentanyl buccal tablet given to put in between upper gum and cheek one hour after a six minute walk test.
16140374|NCT01856114|Other|Placebo Buccal Tablet|Placebo buccal tablet given to put in between upper gum and cheek one hour after a six minute walk test.
16140457|NCT01855464|Procedure|parietal pleurectomy|The parietal pleura is resected for treating primary pneumothorax.
16140458|NCT01855451|Drug|Cetuximab|
16140375|NCT01856114|Behavioral|Questionnaires|Completion of two questionnaires at beginning of study visit. It should take about 10 minutes to complete. At the end of study visit, completion of last questionnaire. It should take about 5 minutes to complete the questionnaire.
16140376|NCT01856101|Drug|BEZ235|The investigational study drug used in this trial is BEZ235, supplied as 200 mg, 300 mg and 400 mg sachets. BEZ235 is administered continuously twice-daily; complete cycle is 28 days. Starting dose is 300mg PO bid. At cycle 1 day 15, based on a clinical assessment, dose is adjusted for the rest of the study:• If no adverse event (AE) or only mild AE (G1) : the dose will be increase to 400 mg bid• If AE = G2 : the patient will continue at 300 mg bid • If G3 AE or higher : BEZ235 will be interrupt until resolved to ≤ G1 then reduce dose to 200 mg bid
16140377|NCT01856088|Device|Inspiron Stent|stent implantation
16140378|NCT01856088|Device|Biomatrix Flex Stent|stent implantation
16140379|NCT01856062|Drug|Placebo|A placebo with similar appearance to dexamethasone will be given with a standard regimen of clomiphene citrate (100mg/day oral for 5 days) for ovulation induction
16140380|NCT01856062|Drug|Dexamethasone|Oral dexamethasone will be added to a standard regimen of clomiphene citrate (100mg/day oral for 5 days) for ovulation induction
16140381|NCT01856049|Other|Collection of umbilical cord blood|Cord blood will be processed in the temperate state it was collected to produce a pure, stem cell product identifiable to patients with Hypoplastic Left Heart Syndrome, and will be stored at a frozen state for their potential, future use in a clinical trial.
16140382|NCT01856036|Procedure|Cryoablation|Cryoablation of breast cancer will be performed using a freeze-thaw technique and an IceCure probe. Cryoablation cycles will be determined by IceCure software programmed by the treating surgeon.
16140383|NCT01856023|Drug|High Dose Interleukin-2|
16140384|NCT01856023|Drug|Ipilimumab|
16140385|NCT01856010|Other|ECT treatment|The decision to administer ECT treatment will have already been made before the subject is approached about study participation. Only individuals who were referred for ECT due to behavior refractory to standard care will be eligible to participate. If they decide to do ECT treatment, they are in the ECT group.
16140386|NCT01856010|Other|Standard Care (Non-ECT group)|The decision to administer ECT treatment will have already been made before the subject is approached about study participation. Only individuals who were referred for ECT due to behavior refractory to standard care will be eligible to participate. If they decide not to do ECT treatment and continue with standard care, they are in the Standard Care (Non-ECT) Group.
16140387|NCT01855997|Drug|Peg-IFN alfa-2a|Participants received Peg-IFN alfa-2a prior to enrollment for at least 24 weeks. Dosing was chosen according to standard of care or at the discretion of the treating physician.
16140388|NCT01855984|Dietary Supplement|Oral mixed tocotrienols|200mg per day
16140389|NCT01855984|Dietary Supplement|Placebo|Capsules containing soya bean oil that has similar appearance with the mixed tocotrienol capsules
16140390|NCT01855971|Dietary Supplement|EGCG|Life Extension, Mega Green Tea Extract Decaffeinated is a dietary supplement containing EGCG extract (45% EGCG). This extract contains 98% total polyphenols and 45% epigallocatechin-3-gallate (EGCG). EGCG administration in Down syndrome patients will result in an improvement of their cognitive performance.
16140391|NCT01855971|Dietary Supplement|Placebo|Same capsules containing rice flour. No active treatment is given.
16140392|NCT01855971|Other|Cognitive training|Feskits program 3 times per week (1 hour/session) Patients in this arm of the trial carried out computerized online training drawn from the Feskits program (www.feskits.com), chosen to have attention, memory and executive function components. Specifically the sessions included the following exercises: sustained attention, attention/perception, working memory, auditory and visual memory, executive function and language.
16140393|NCT01855958|Procedure|DIMST|The investigators used electro acupuncture of 2 Hz during 30 minutes.
16140394|NCT01855958|Procedure|Placebo-sham|Electro acupuncture with rubber electrodes, without current passing.
16140395|NCT01855945|Biological|Swine Influenza|Comparison of different dosages of vaccines
16140396|NCT01855932|Behavioral|Technology Supported|All participants will complete 8 weeks of recording of dietary intake, weight, and physical activity on a smartphone application. Time-stamped data from the smartphone will upload automatically to the application server, where it will be visible to the lifestyle coach. The participant's real-time diet, activity and weight data relative to their goals will be visually depicted on the participant's smartphone. The coach will monitor participant adherence and send supportive text messages. Response to the application will be assessed 3 weeks after enrollment into the study; measured by number of food items recorded between weeks 1-3 of the intervention; an indicator of use and adherence. Based on adherence, some participants may receive 4 telephone coaching sessions between weeks 5 and 8. Telephone coaching sessions will include feedback on self-monitoring and goal attainment, problem solving, and motivational interviewing.
16140397|NCT01855919|Drug|Duloxetine|Administered orally
16140398|NCT01855919|Drug|Placebo|Administered orally
16140399|NCT01855906|Procedure|Gap balanced surgical technique|Gap balanced surgical technique
16140400|NCT01855906|Procedure|Measured resection|Measured resection surgical technique
16140401|NCT01855893|Other|Auto-acupressure|Patients will receive instructions about how to apply auto-acupressure once in a day during one week by their health care professionals.This technique will be complementary to the conventional treatment.
16140402|NCT01855893|Other|Conventional treatment|Conventional treatment consist of: 7 days with paracetamol 1g /8 hours and/ or ibuprofen 400mg/ 8 hours, and tetrazepam 50 mg/ 12 hours
16140403|NCT01855880|Biological|AbGn-168H|
16140404|NCT01855880|Biological|placebo|
16140405|NCT01855867|Drug|Coformulated Elivitegravir (150mg), Combicistat (150mg), Emtricitabine (200mg), Tenofovir DF (300mg)|
16140406|NCT01855854|Drug|Icotinib|Icotinib: 250 mg is administered orally three times per day, until disease progression or untolerable toxicity.
16140407|NCT01855841|Drug|Hemin|A single perfusion of 4mg/kg hemin diluted in 100mL of NaCl 0.9% administered as soon as possible after the end of the ERCP followed by 100mL of NaCL 0.9% to flush the vein
16140408|NCT01855841|Drug|placebo|A single perfusion of 100mL of NaCl 0.9% administered as soon as possible after the end of the ERCP followed by 100mL of NaCL 0.9% to flush the vein
16140409|NCT01855828|Drug|Pertuzumab|First dose is 840mg, maintenance dose is 420mg. Pertuzumab will be administered once every 3 weeks for 24 weeks (8 doses total)
16140410|NCT01855828|Drug|Trastuzumab|"For weeks 1-12, first dose is 4 mg/kg, maintenance dose is 2 mg/kg administered every week (12 doses total).
~For weeks 13-24, dose is 6mg/kg administered every 3 weeks (4 doses total)."
16140411|NCT01855828|Drug|Paclitaxel|Administered at 80mg/m2 every week from week 1 to 12 (12 doses total).
16140412|NCT01855828|Drug|5-fluorouracil|Administered at 500 mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
16140413|NCT01855828|Drug|Epirubicin|Administered at 75mg/m2 every 3 weeks during weeks 13-24 (4 doses total).
16140414|NCT01855828|Drug|Cyclophosphamide|Administered at 500mg/m2 for every 3 weeks during weeks 13-24 (4 doses total).
16140415|NCT01855789|Drug|Tocilizumab (TCZ)|TCZ will be administered at a dose of 162 milligrams (mg) via SC injection weekly (if body weight is greater than or equal to [>/=] 100 kilograms [kg]) or every 2 weeks (if body weight was less than [<] 100 kg).
16140416|NCT01855789|Drug|Methotrexate (MTX)|MTX will be administered at a stable dose (15 mg to 25 mg per week) orally.
16140417|NCT01855789|Drug|Placebo (PBO)|PBO matching to MTX will be administered orally.
16140418|NCT01855776|Device|Fitbit|Fitbit Zip is a wireless pedometer that tracks steps of participants, and will be offered in conjunction with a tailored website with customized information for participants, employers, and/or charities.
16140419|NCT01855776|Behavioral|Cash Incentives|Incentives will be awarded to participants for meeting specified weekly step goals as measured by a pedometer.
16140420|NCT01855776|Behavioral|Charitable Incentives|Incentives will be awarded to charities selected by participants should the latter meet specified weekly step goals measured by a pedometer.
16140421|NCT01855776|Other|Usual Care|"The usual care programme consists of educational materials designed by the Singapore Health Promotion Board. It includes material on how to stay active, walking programmes, and healthy eating."
16140422|NCT01855763|Drug|Metformin|
16140423|NCT01855763|Drug|Insulin|
16140424|NCT01855750|Drug|Ibrutinib|560 mg capsules administered by mouth once daily (21-day cycles)
16140425|NCT01855750|Drug|Placebo|4 matched capsules administered by mouth once daily (21-day cycles)
16140426|NCT01855750|Drug|Rituximab|375 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
16140427|NCT01855750|Drug|Cyclophosphamide|750 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
16140428|NCT01855750|Drug|Doxorubicin|50 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
16140429|NCT01855750|Drug|Vincristine|1.4 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
16140430|NCT01855750|Drug|Prednisone (or equivalent)|100 mg capsules administered by mouth once daily on Day 1 to Day 5 of each cycle
16140431|NCT01855737|Drug|Warfarin|Prescribe warfarin to the patients who are needed.
16140432|NCT01855724|Drug|Gemcitabine-Pazopanib|
16140433|NCT01855711|Drug|GR68755 (Alosetron hydrochloride) 1 mg tablet|1 tablet (1 mg) once a day
16140434|NCT01855698|Other|Observation|
16140435|NCT01855685|Genetic|X vivo gene therapy|Transplantation of patient's autologous CD34+ cells transduced with lentiviral vector containing GP91PHOX gene
16140436|NCT01855672|Device|Stimulation of the Occipital Nerves|Electrical stimulation of the occipital nerves.
16140437|NCT01855646|Other|Structured Sign Out Form|
16140438|NCT01855633|Device|Traditional Theta burst stimulation (TBS)|
16140439|NCT01855633|Device|Modified TBS rTMS|
16140440|NCT01855633|Device|Sham rTMS|
16140441|NCT01855607|Other|topical menthol|7.5% Methylsalicylate / 2% Menthol Lotion
16140442|NCT01855607|Other|placebo cream|The control (placebo) product has same amount of Methylsalicylate (7.5%) and no menthol.
16140443|NCT01855594|Drug|Lithium Carbonate|250 mg/tablet, 6 weeks course of oral administration
16140444|NCT01855594|Drug|Placebo|placebo tablet, 6 week course of oral administration
16140445|NCT01855581|Drug|pediatric sedation (propofol, ketamine, etc)|"Presedation assessment was performed by hospitalists and pediatric sedation was performed by protocol in the sedation unit.
~Data on demographics, primary illness, ASA, snoring history, URI symptom, medications used, procedure and recovery times, medication doses, outcomes of anesthesia, airway interventions and adverse events were collected retrospectively."
16140446|NCT01855568|Procedure|Single-dose Methotrexate|"Participants in the single-dose protocol group received intramuscular methotrexate at single dose of 50 mg/m2 on day 0 (the initial day of treatment). The β-hCG levels were then measured on day 4 and 7. If there was at least 15% β-hCG drop between day 4 and 7, the treatment was deemed successful and the participants were then followed with weekly β-hCG measurements until the results was negative. If a 15% drop on day 4 and 7 did not occur, a second dose was administrated on day 7 and β-hCG levels were then measured on day 11 and 14. Participants were referred for surgical treatment if β-hCG levels fell <15% between day 11 and 14."
16140447|NCT01855568|Procedure|Two-dose methotrexate protocol|"Participants in the two-dose protocol group received intramuscular methotrexate twice at dose of 50 mg/m2 on day 0 and 4. A third dose of methotrexate was given on day 7 if β-hCG levels did not fall 15% between day 4 and 7 after two-dosing. A fourth dose was administered on day 11 if β-hCG levels fell <15% between day 7 and 11. Then, a final β-hCG level was checked on day 14. If a 15% drop was not seen, the medical treatment was deemed refractory and the patients were referred for surgical treatment."
16140448|NCT01855555|Drug|sedation with propofol|"When a patient is admitted to the Pediatric Sedation Center, a presedation assessment is performed by hospitalists. Then Pediatric sedation is performed by protocol in the sedation unit.
~Data on demographics, primary illness, ASA, snoring history, URI symptom, medications used, procedure and recovery times, medication doses, outcomes of anesthesia, airway interventions and adverse events will be reported."
16140449|NCT01855542|Other|0.9% normal saline|In each group, patients received either 0.9% normal saline or plasmalyte solution until end of surgery.
16140450|NCT01855542|Other|plasmalyte|In each group, patients received either 0.9% normal saline or plasmalyte solution until end of surgery.
16140451|NCT01855529|Drug|Ropivacaine in one arm and placebo (NaCl) in the other arm|
16140452|NCT01855516|Drug|Heparin|
16140453|NCT01855503|Procedure|Core Biopsy|
16140454|NCT01855490|Drug|Exenatide|
16140455|NCT01855477|Procedure|Histological biopsy procedure|
16140456|NCT01855464|Procedure|wedge resection|Complementary to parietal pleurectomy lung tissue is resected.
16140461|NCT01855438|Behavioral|Living Donor Transplant Education|The Living Donor Transplant Education informs kidney transplant candidates about living donor transplants and provides guidance in broaching and maintaining discussion about the topic.
16140462|NCT01855425|Radiation|Radiation|Subjects to receive standard of care CT scan and additional Cone Beam CT scan.
16140463|NCT01855412|Other|PAD endovascular treatments|All FDA-cleared endovascular PAD treatments
16140464|NCT01855399|Behavioral|Peer Coaching|All participants will be assigned to a peer coach, who is a Detroit VA diabetes patient who previously had poor glycemic control but is currently in good control. Participants will receive information on their lab and blood pressure values and will be scheduled for an initial visit with their coach. The coach will then help them list questions and concerns they wish to discuss with their health care provider, practice raising their questions and concerns, and develop an action plan to address barriers to self-management they have identified. During the next six months, coaches will call their assigned peers once a week to provide support for their action steps.
16140465|NCT01855399|Behavioral|Decision Aid|The iDecide tool is designed to present key tailored, evidence-based information on diabetes and diabetes treatments. Importantly for a peer support intervention, all content information will be provided through the tool, with the role of the peer mentor being to assist the participant to go through the program and participate in helping the patient formulate questions and concerns to discuss with their health care provider, to set their own behavioral goals and action steps, and to help the participant practice raising the issues they plan to discuss with their health care provider.
16140466|NCT01855386|Other|Subjects with Gestational Diabetes|Subjects with a history of Gestational Diabetes will provide blood samples, blood pressure measured with a blood pressure cuff, pulse, height, weight, and ultrasound of the liver at the 6 week postpartum and 6 month postpartum visits.
16140467|NCT01855386|Other|Controls without Gestational Diabetes|Matched control subjects without gestational diabetes will provide blood samples, blood pressure measured with a blood pressure cuff, pulse, height, weight, and ultrasound of the liver at the 6 week postpartum and 6 month postpartum visits.
16140468|NCT01855373|Dietary Supplement|PEAK ATP® with GlycoCarn®|PEAK ATP® with GlycoCarn® {Glycine Propionyl-L-Carnitine Hydrochloride, USP (500mg/capsule) and Adenosine 5'-Triphosphate Disodium Salt (100mg/capsule)}: 2 capsules twice daily on an empty stomach
16140469|NCT01855373|Dietary Supplement|PEAK ATP®|PEAK ATP® (Adenosine 5'-Triphosphate Disodium Salt (100mg/capsule): 2 capsules twice daily on an empty stomach
16140470|NCT01855373|Dietary Supplement|GlycoCarn®|GlycoCarn® (Glycine Propionyl-L-Carnitine Hydrochloride, USP (500mg/capsule): 2 capsules twice daily on an empty stomach
16140471|NCT01855373|Other|Placebo|Placebo: 2 capsules twice daily on an empty stomach
16140472|NCT01855360|Drug|Tauroursodeoxycholic Acid and Doxycycline|
16140473|NCT01855347|Device|Near Infrared Spectroscopy|NIRS Monitoring with four channels regional areas of the preterm infant, such as: Submandibular, Periumbilical, Abdominal (Spleen region) and infant thigh.
16140474|NCT01855334|Drug|Spironolactone|
16140475|NCT01855334|Dietary Supplement|L-arginine|
16140476|NCT01855334|Drug|Placebo|
16140477|NCT01855321|Drug|Vitamin D|The cholecalciferol capsule with respect to size and shape and 2) the intervention group will take 1 oral capsule of cholecalciferol 50,000 IU (Bio-Tech Pharmacal, Fayetteville, AR USA) once weekly for 8 weeks followed by 50,000 IU once monthly for 4 months.
16140478|NCT01855321|Drug|Placebo|The placebo capsule is to be identical to the cholecalciferol capsule with respect to size and shape and 2) the intervention group will take 1 oral capsule of cholecalciferol 50,000 IU (Bio-Tech Pharmacal, Fayetteville, AR USA) once weekly for 8 weeks followed by 50,000 IU once monthly for 4 months.
16140479|NCT01855308|Procedure|Single site robotic chole|Cholecystectomy
16140480|NCT01855308|Device|da Vinci Si Surgical System|minimally invasive robotic surgical system designed to facilitate complex procedures
16140481|NCT01855295|Dietary Supplement|Protein Supplement|During the treatment phase, study subjects are advised to increase protein intake to 1.2 g/kg/day for 12 weeks. In addition to any protein supplementation the participant is on, supervised supplementation on each dialysis session is provided. Each participant receives 45 grams of liquid protein supplement (Provide Sugar Free produced by Provide Nutrition LC) at each dialysis treatment for additional 12 weeks for total study duration of 24 weeks.
16140482|NCT01855282|Behavioral|Behavioral Intervention|Intervention participants attended up to 10 educational sessions teaching them about diabetes, and modifiable lifestyle factors (behaviors) to reduce the risk of diabetes by controlling weight. Sessions were conducted by Promotoras using culturally sensitive and appropriate materials and themes. Group activities and support were also emphasized. The control participants like the intervention were measured and interviewed before and again after the intervention sessions, but received no educational instruction or materials.
16140483|NCT01855269|Dietary Supplement|Lactobacillus reuteri|Lactobacillus reuteri (BioGaia, Stockholm, Sweden):at a dose of 100 million colony forming unit in 5 drops, 30 minutes after feeding, once per day for 3 weeks
16140484|NCT01855269|Dietary Supplement|Herbal drop|Herbal drop containing sodium bicarbonate, Pimpinella anisum oil,foeniculum vulgare oil, Mentha piperita (Babs, Berko, Istanbul, Turkey):5 drops 30 minutes after feeding, once per day for 3 weeks
16140485|NCT01855269|Dietary Supplement|placebo sterile water|
16140486|NCT01855256|Drug|Oxybutynin|Oxybutynin is started at a dose of 2.5 mg / day and increased gradually until an effective dose without exceed 7.5 mg / day up to 6 weeks.
16140487|NCT01855256|Drug|Placebo|Placebo is started at a dose of 2.5 mg / day and increased gradually until an effective dose without exceed 7.5 mg / day up to 6 weeks.
16140488|NCT01855243|Drug|regular insulin|
16140489|NCT01855243|Drug|70/30 insulin|
16140490|NCT01855243|Drug|Glargine|
16140491|NCT01855243|Drug|glulisine|
16140492|NCT01855230|Drug|ASM-024|ASM-024 b.i.d for 14 days
16140493|NCT01855230|Drug|Placebo|Placebo b.i.d. for 14 days
16140494|NCT01855217|Drug|Sugammadex|1 mg/kg total BW based sugammadex reversal of deep block
16140495|NCT01855217|Drug|Sugammadex|1 mg/kg ideal BW based sugammadex reversal of deep block
16140496|NCT01855217|Drug|Placebo|0,9% NaCl
16140497|NCT01855204|Radiation|Computed tomographic urography|Computed tomographic (CT) urography was done with the protocols of low voltage and low iodine concentration.
16140498|NCT01855178|Device|Emfit Movement Monitor|Factory settings
16140501|NCT01855152|Other|Treatment as usual|Treatment delivered as usual in the care home
16140502|NCT01855139|Drug|Rivaroxaban (Xarelto, BAY59-7939)|15 mg OD or 20 mg OD
16140503|NCT01855126|Other|Blue light|After a two week baseline collection period, half of the subjects will initially be given light masks that deliver blue light through the closed eyelids, while subjects are sleeping. The light mask will always be turned on 120 min before estimated core body temperature minimum (CBTmin); it is expected that blue light exposure will delay the timing of the CBTmin.
16140504|NCT01855126|Other|Red light|After a two week baseline collection period, half of the subjects will initially be given light masks that deliver red light through the closed eyelids, while subjects are sleeping. The light mask will always be turned on 120 min before estimated core body temperature minimum (CBTmin); it is expected that red light exposure will have no effect on the timing of the CBTmin.
16140505|NCT01855113|Device|Invisalign|
16140506|NCT01855100|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Starting dose (3 weeks): 15 mg BID, then 15 mg OD or 20 mg OD.
16140507|NCT01855074|Drug|Risperidone|Risperidone 25 milligram (mg) will be given as intramuscular injection for every 2 weeks up to 6 months. Participants with persistent symptoms and/or requiring higher doses of antipsychotics will be administered higher doses of risperidone. Doses will be adjusted as per Investigator's discretion.
16140508|NCT01855061|Procedure|Biopsy|"Histological biopsy of the index lesion (a radiological measurable lesion on which biopsy is performed) at baseline, as well as when showing progressive disease. Histological biopsies will be subjected to DNA sequencing to assess the mutational profile, as well as to analysis of carboxylesterase activity."
16140509|NCT01855061|Procedure|Blood samples|Blood samples will be taken at baseline to determine patient's genetic background variation (germline DNA).
16140510|NCT01855061|Procedure|Pharmacokinetics|Blood samples will be taken for pharmacokinetic analysis of the active irinotecan metabolite (SN-38).
16140511|NCT01855061|Procedure|Midazolam clearance test|Patients who are being treated in Rotterdam will be subjected to blood draws for validation of the earlier developed midazolam phenotyping test (midazolam clearance test), which may be an indicator for pharmacokinetics of irinotecan.
16140512|NCT01855048|Biological|N-Rephasin® SAL200|continuous intravenous infusion over 60 minutes
16140513|NCT01855048|Other|INT200-Placebo|Formulation buffer for continuous intravenous infusion over 60 minutes
16140514|NCT01855035|Other|prolonged ECG monitoring|10-day Holter ECG measurement
16140515|NCT01855035|Other|standard care|Usual care according to current guidelines (minimum of 24 hours of cardiac monitoring).
16140516|NCT01855022|Behavioral|MI + IVR|Participants in the intervention group received motivational interviewing from a registered nurse who is trained and proficient in this behavioral change modality. In addition, participants were instructed to make a daily toll-free call to an automated interactive voice response (IVR) system provided by Pharos Innovations® (Chicago, IL) for 30 days after discharge from the index admission. On each call patients heard a pre-recorded voice that goes through a series of questions about symptoms and the patient's daily weight. Information from the IVR system was automatically downloaded to a secure Internet site for review by the nurse at each hospital location.
16140517|NCT01855009|Dietary Supplement|MannaBears|Subjects will be administered 4 MannaBears daily
16140518|NCT01855009|Dietary Supplement|AlgaeCal Calcium|Subjects will be administered 750 mg AlgaeCal Calcium
16140519|NCT01855009|Dietary Supplement|Calcium carbonate|Subjects will be administered 1000 mg calcium carbonate
16140520|NCT01855009|Dietary Supplement|Vitamin D3|Subjects will be administered 800 IU vitamin D3
16140521|NCT01854996|Drug|PF-05089771|450mg
16140522|NCT01854996|Drug|PF-05089771|450mg
16140523|NCT01854996|Drug|PF-05089771|450mg
16140524|NCT01854970|Drug|esomeprazole|Patients with pharyngolaryngeal symptoms will have a clinical evaluation, laryngoscopy, and pharyngoesophageal pH-impedance. Then a treatment by esomeprazole during 8 weeks in the term of which the second clinical evaluation and pH-impedance will be made.
16140525|NCT01854957|Biological|Autologous Mesenchymal Stem Cells|Single dose of 1-2 x 1000000 cells/Kg body weight
16140526|NCT01854944|Drug|Brexpiprazole 1mg to 4mg|
16140527|NCT01854931|Behavioral|Tai Ji Quan|single aim intervention
16140528|NCT01854918|Biological|Evolocumab|Administered by subcutaneous injection either every 2 weeks or once a month (patient preference) using a prefilled autoinjector pen
16140529|NCT01854918|Drug|Standard of Care|Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes
16140530|NCT01854905|Other|No Treatment|Patients attending consultation for LASIK on Day 1. No intervention or treatment is administered during the study.
16140531|NCT01854892|Other|Manipulation|High velocity short amplitude thrust spinal manipulation applied to the lumbar spine.
16140532|NCT01854892|Other|Mobilization|Static isometric contractions of the lumbar spine to induce spinal mobilization
16140533|NCT01854892|Other|Laser Therapy|Cold laser applied to the paravertebral muscles in the lumbar region
16140534|NCT01854879|Device|Nucleus 6 sound processor|
16140535|NCT01854866|Other|Drug-packaging microparticles|Drug-packaging microparticles are perfused to the pleural or peritoneal cavity of patients with four times per week.
16140536|NCT01854853|Behavioral|STYLE Brazil|Multifamily group HIV/STI Prevention Intervention
16140537|NCT01854853|Behavioral|Health Promotion|Health promotion intervention
16140538|NCT01854827|Drug|Intravenous immunoglobulin (IVIG)|All participants will receive the same dose of IVIG at the same intervals in an open-label fashion as long as the subject does not have any increased risk for toxicity for any IVIG infusion. IVIG will be initiated on day 3 (up to day 5) after HPE surgery (HPE is day 0) at a dose of 1 gm/kg body weight by slow intravenous infusion over at least 4 hours. The same dose (1 gm/kg) and duration of infusion will be repeated on day 30 and day 60 after HPE.
16140539|NCT01854814|Drug|Mycophenolate mofetil|Mycophenolate mofetil 1.5g/day plus maximum tolerated labeled dose losartan
16140540|NCT01854814|Drug|Losartan|Maximum tolerated labeled dose of Losartan
16140541|NCT01854801|Other|Individual medical Care|Individual medical care in occupational and environmental diseases centers
16140721|NCT01853501|Procedure|Autologous fat grafting|ADSC ovary injection
16140542|NCT01854801|Other|Individual electromagnetic exposures|During 7 days, patient hold a dosimeter measuring their electromagnetic exposures for FM, TV, GSM, DECT, WIFI, TETRA and relay antenna emissions. During this week, patients notify intensity and time of their symptoms on a self-questionary
16140543|NCT01854788|Other|Autogenic drainage|It was performed following J. Chevallier recommendations.In this trial it was considered a self-administrated technique because physiotherapist only gave oral advice in order to ensure a correct performance of the technique.
16140544|NCT01854788|Other|Slow expiration with glottis opened in lateral posture|It was performed following Postiaux´s recommendations. In this trial the technique was considered active-assisted because the physiotherapy played a role important in their execution.
16140545|NCT01854788|Other|Temporary-positive expiratory pressure|The diaphragmatic breathing was required for this technique whereas patients remain seated in front of the device with a nose clip. The inspiratory /expiratory ratio was 1:2.It was taken into account as a device-administrated technique for this trial.
16140546|NCT01854775|Drug|E/C/F/TAF|Tablets administered orally with food.
16140547|NCT01854775|Drug|E/C/F/TAF (Low Dose)|90/90/120/6 mg STR administered once daily orally with food.
16140548|NCT01854762|Drug|Raltegravir|a raltegravir-based antiretroviral regimen (AZT+3TC+Raltegravir) will be administered for intervention arm patients (AZT+3TC will be administered in a fixed combination of AZT 300mg +3TC 150 mg, BID. Raltegravir will be administered in a dosis of 1 400 mg pill BID).
16140549|NCT01854762|Drug|Lopinavir/Ritonavir|The second arm (comparator)patients will use a regimen composed by AZT+3TC (same dosis/schedule of active arm)+ LPV 200mg combined with rtv 50 mg, 2 pills BID
16140550|NCT01854749|Drug|S1 combined with cisplatin|
16140551|NCT01854736|Drug|Grazax|GRAZAX
16140552|NCT01854736|Other|Placebo|Placebo
16140553|NCT01854723|Drug|Switching to NPH insulin|Patients in this arm will be transitioned from insulin glargine to NPH insulin with subsequent titration according to algorithm within protocol. If needed, meal-time insulin will be added during study period.
16140554|NCT01854723|Drug|Continuation of insulin glargine|Patients in this group will serve as a control group, and information will be collected regarding the safety, effectiveness, and cost of treatment for use in this study.
16140555|NCT01854710|Drug|ADASUVE 10 mg 2 doses 2 hours apart|Inhaled loxapine 10 mg 2 doses 2 hours apart
16140556|NCT01854710|Drug|Inhaled Placebo|Staccato placebo via inhalation x 2 at 2 hours apart
16140557|NCT01854710|Drug|Oral moxifloxacin 400 mg|Oral moxifloxacin 400 mg single dose
16140558|NCT01854710|Drug|Oral placebo|Oral capsule identical in appearance to moxifloxacin
16140559|NCT01854697|Drug|ABT-450/r/ABT-267, ABT-333|Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
16140560|NCT01854697|Drug|Ribavirin|Tablet
16140561|NCT01854697|Drug|Telaprevir|Film-coated tablet
16140562|NCT01854697|Drug|Pegylated Interferon alpha 2-a (PegIFN)|Pre-filled syringe
16140563|NCT01854684|Drug|Temoporfin|Given IV
16140564|NCT01854684|Procedure|Therapeutic Conventional Surgery|Undergo surgical resection
16140565|NCT01854684|Drug|Photodynamic Therapy|Undergo intraoperative PDT
16140566|NCT01854684|Other|Laboratory Biomarker Analysis|Correlative studies
16140567|NCT01854684|Other|Pharmacological Study|Correlative studies
16140568|NCT01854671|Other|family planning counseling let by community health workers|The family planning counseling sessions led by community health workers will present advantages of birth spacing, available methods of postpartum contraception, contraindications (if any) for the method, when each method can be safely started postpartum, where each method can be obtained, and importance of 6 week postpartum clinic follow-up. There will also be a take-home contraceptive method brochure given at conclusion of information session -primarily pictorial and in Arabic, to facilitate discussion at home with husbands and family members.
16140569|NCT01854658|Drug|GFF MDI (PT003)|GFF MDI administered as two puffs BID
16140570|NCT01854658|Drug|GP MDI (PT001)|GP MDI administered as two puffs BID
16140571|NCT01854658|Drug|FF MDI (PT005)|FF MDI administered as two puffs BID
16140572|NCT01854658|Drug|Placebo|
16140573|NCT01854645|Drug|GFF MDI|GFF MDI administered as two puffs Bis in Di.e. Twice Daily (BID)
16140574|NCT01854645|Drug|GP MDI|GP MDI administered as two puffs BID
16140575|NCT01854645|Drug|FF MDI|FF MDI administered as two puffs BID
16140576|NCT01854645|Drug|Open-label tiotropium bromide inhalation powder (Spiriva® Handihaler®)|Taken as 1 capsule daily containing 18 µg of open-label tiotropium via the Handihaler dry powder inhaler (DPI)
16140577|NCT01854645|Drug|Placebo MDI|Inhaled placebo administered as two puffs BID
16140578|NCT01854632|Biological|SIIL Live Attenuated Influenza Vaccine|Trivalent live-attenuated influenza vaccine 2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
16140579|NCT01854632|Biological|Matched placebo|Matched placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
16140580|NCT01854619|Device|Photodisinfection (antimicrobial photodynamic therapy, aPDT)|A 0.03% solution of methylene blue is irrigated into the involved paranasal sinus followed by placement of a saline filled balloon with a center light diffusing fiber optic. This is illuminated at 150 mW/cm2 power density for 8 minutes. This is repeated for each involved sinus.
16140581|NCT01854619|Device|Saline irrigation|The active comparator arm will receive saline irrigation via syringe that is administered using a sinus irrigation catheter under endoscopic control.
16140582|NCT01854606|Drug|AEB071|a Protein Kinase C Inhibitor
16140583|NCT01854606|Drug|Everolimus|mTOR inhibitor
16140584|NCT01854593|Drug|Bevacizumab|0.16 mg/0.05 ml bevacizumab (single injection on 1 day before operation)
16140585|NCT01854593|Procedure|Vitrectomy|vitrectomy of 25 gauge system.
16140586|NCT01854593|Device|Sham injection|Sham injection one day before vitrectomy
16140587|NCT01854567|Biological|Infusion of one MPC expanded cord unit and one unexpanded cord unit|Infusion of one MPC expanded cord unit and one unexpanded cord unit.
16140588|NCT01854567|Biological|Infusion of two unexpanded cord blood units.|Umbilical Cord Blood.
16140593|NCT01854528|Drug|ABT-450/r/ABT-267, ABT-333|Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
16140594|NCT01854528|Drug|Ribavirin|Tablet
16140595|NCT01854528|Drug|Pegylated Interferon a-2a (PegINF)|Pre-filled syringe
16140596|NCT01854528|Drug|Telaprevir|Film-coated tablet
16140597|NCT01854515|Drug|Budesonide|
16140598|NCT01854515|Drug|Dexamethasone acetate|
16140599|NCT01854502|Behavioral|Oral hygiene and fluoride use|Parents were given instructions how to brush and clean between teeth and to use fluoride toothpaste two times a day.
16140600|NCT01854502|Behavioral|Diet and use of xylitol|Parents were asked to fill in one-day diaries of their own diet in the waiting room. The dental professional pointed out the frequency of meals and snacks, as well as suggested the timing of xylitol products.
16140601|NCT01854489|Drug|Placebo|The volunteers will be given Oral placebo at 20.00 for 7 days [Phase 1 ]
16140602|NCT01854489|Drug|Rifampicin|The volunteers will be given oral rifampicin (Rimapen, Orion, Finland) 600 mg as a single daily dose at 20.00 for 7 days
16140603|NCT01854489|Drug|Buprenorphine|The volunteers will be given single dose of 0,4 mg intra venous buprenorphine or 0,6 mg sublingual buprenorphine on day 5.
16140604|NCT01854476|Device|pad-gauze with tranexamic acid (Hemostopan™)|The use of pad-gauze containing tranexamic acid (Hemostopan™)
16140605|NCT01854463|Drug|Vitamin D3|2000IU per day
16140606|NCT01854463|Drug|placebo|elemental calcium 200mg per day per 24 weeks
16140607|NCT01854450|Other|Asymmetrical Lateral Decubitus|"After randomization, women are postured in pronounced lateral decubitus (side opposite to the back of the fetus), with the inferior leg in extension, and the superior leg in hyperflexion, during 1 hour (minimum 30 minutes).
~Then, women are encouraged to take this posture during labor as frequently as possible if the fetus remains in occipitoposterior position"
16140608|NCT01854450|Other|control|usual obstetrical care
16140609|NCT01854437|Drug|Mg Oxide|250 mg orally for 4 weeks
16140610|NCT01854424|Other|Bronchoalveolar lavage (BAL) before day 2 , between days 5-7 and days 10-14 of evolution.|All the samples will be obtained during current care in the first week of evolution, and the last set of samples (BAL and blood sample between day 10-14) only in patients still under ventilation at this time point.
16140611|NCT01854411|Other|analgesic measure|ibuprofen and ketoprofen measured into breast milk
16140612|NCT01854398|Device|CPAP group|Enrolled patients are randomized to CPAP group or sham-CPAP group by 1:1 ratio. The patients in each group will undergo CPAP or sham-CPAP for 3 months.
16140613|NCT01854398|Device|sham-CPAP group|Enrolled patients are randomized to CPAP group or sham-CPAP group by 1:1 ratio. The patients in each group will undergo CPAP or sham-CPAP for 3 months. Sham CPAP consists of a CPAP machine that is modified to include a large hidden leak in the exhaust port of the mask to disperse the therapeutic pressure.
16140614|NCT01854385|Drug|Sumatriptan 100 mg|This is a single-arm, unblinded study of treatment for post-traumatic headache with the open label medication sumatriptan and is being undertaken to test necessary study instruments and procedures, establish feasibility and determine side effects in a population with complicated mild, moderate and severe TBI.
16140615|NCT01854372|Drug|R-HCVAD and R-MC|
16140616|NCT01854359|Drug|Idebenone|
16140617|NCT01854346|Behavioral|Social skills group training, KONTAKT|KONTAKT is a manual-based social skills group training for children with high functioning autism spectrum disorder (ASD). The program is based on cognitive behavioral therapy (CBT) principles and knowledge of social cognition. The group treatment includes exercises in social skills as well as discussions of social cognition, social interaction, self-reflection and description of themselves and others. The children are training to make contact, to understand and follow social rules, to become aware of themselves and others, to perceive verbal and nonverbal signals in a communication, to develop problem solving skills and coping strategies to manage conflict and to enhance their self-confidence. Intervention includes 12 (brief intervention) and 24 (long intervention) sessions. Each group consists of 4-8 children/adolescents ant two group leaders. The treatment are conducted in cooperation with both parents and teachers.
16140618|NCT01854333|Other|ADOS module 1-4 or ADI-R|
16140619|NCT01854320|Behavioral|Acceptance-based treatment|
16140620|NCT01854320|Behavioral|Standard behavioral treatment|
16140621|NCT01854307|Procedure|Pneumoperitoneum and SVV/PPV|
16140622|NCT01854294|Drug|GM604|GM604 treated group subject will receive a slow IV bolus injection (~1min) of 6.4 mL (320mg @50 mg/mL=6.4 mL) for each dose. A total of 6 doses will be administered over two weeks (on Mondays, Wednesdays and Fridays for the first 2 weeks).
16140623|NCT01854294|Drug|Placebo comparator|Placebo comparator group subject will receive a slow IV bolus injection (~1min) of 6.4 mL bacteriostatic saline for each dose. A total of 6 doses will be administered over two weeks (on Mondays, Wednesdays and Fridays for the first 2 weeks).
16140624|NCT01854268|Drug|Healthy adults who receive capsaicin|Participants will be seated in a comfortable chair and fitted with cotton elastic bands designed to measure changes in chest wall and abdominal movement during cough. The participant will hold a facemask attached to a pneumotachograph, nebulized, and dosimeter. The participant will receive 3 nebulized doses of 200 microMolar capsaicin through the facemask. The participants will have a minute in between each presentation and water will be available at all times.
16140625|NCT01854255|Drug|doxorubicin and cisplatin|doxorubicin and cisplatin as intraperitoneal chemotherapy
16140626|NCT01854242|Other|Glycogen Storage Disease type Ia patients|The participants will have one blood draw for this study. The test will be performed on the blood.
16140627|NCT01854229|Device|Prometra Programmable Intrathecal Infusion Pump|There are two enrollment groups (arms). One is for new patients who are going to have a Prometra Pump implanted. The other arm is for patients who were part of the IDE study prior to FDA approval of the pump, and are willing to continue to be followed as part of a study.
16140628|NCT01854216|Drug|Rotigotine transdermal patch 1mg / 24 hours|Rotigotine transdermal patch, repeated dose application over 24 hours; 1 mg / 24 hours
16140629|NCT01854216|Drug|Rotigotine transdermal patch 2 mg / 24 hours|Rotigotine transdermal patch, repeated dose application over 24 hours; 2 mg / 24 hours
16140630|NCT01854216|Drug|Rotigotine transdermal patch 4 mg / 24 hours|Rotigotine transdermal patch, repeated dose application over 24 hours; 4 mg / 24 hours
16140631|NCT01854203|Drug|Inductive chemotherapy + concurrent cisplatin and IMRT|Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (30mg/m2，on day 1) repeated every week for 6 cycles during radiotherapy.
16140632|NCT01854203|Drug|Inductive chemotherapy + IMRT|Patients receive Gemcitabine (800mg/m2 on day 1,8) and cisplatin (80mg/m2 on day 1)of a 21 day cycle, patients received four cycles chemotherapy before the radiotherapy, then receive radical radiotherapy with IMRT.
16140633|NCT01854190|Device|WatchPAT|BP was measured by oscillometric method on automatic device. Endothelial function was assessed by peripheral arterial tonometry (PAT) by EndoPAT2000® and the OSA diagnosis also through PAT, using the portable device WatchPAT200®. Anthropometric evaluation was performed through measurements of waist, hip and neck circumference, body mass index, waist to height ratio (WHtR), and body composition assessed by bioelectrical impedance.
16140634|NCT01854177|Drug|Aprepitant|
16140635|NCT01854177|Drug|Placebo|
16140636|NCT01854164|Dietary Supplement|HGE (hydrolyzed ginseng extract)|
16140637|NCT01854164|Dietary Supplement|Placebo|
16140638|NCT01854151|Other|New Labeling/Dosing Strategy|Parents whose children are prescribed liquid medication will receive medications with health literacy informed labels and dosing instruments
16140639|NCT01854138|Device|Prevena Incision Management System|Prevena Incision Management system will be applied to clean surgical wounds of patients undergoing Total Knee Arthroplasty or Total Hip Arthroplasty, immediately post-operatively. The unit will remain in place and functional for 7-8 days.
16140640|NCT01854125|Biological|autologous bone marrow mesenchymal stem cells transplantation|Autologous MSCs were infused to patients using interventional method via hepatic artery . The catheter was inserted to proper hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography, autologous bone marrow MSCs were infused slowly for 20-30 minutes.
16140641|NCT01854125|Biological|autologous bone marrow msenchymal stem cells transplantation|
16140642|NCT01854099|Biological|PEP-CMV|500 µg of PEP-CMV vaccine given intradermally on day 6-8 of each monthly TMZ cycle (standard 200 mg/m^2 x 5 days) with group 1.
16140643|NCT01854099|Biological|PEP-CMV|500 µg of PEP-CMV vaccine given intradermally on day 22-24 of each monthly TMZ cycle (standard 200 mg/m^2 x 5 days) with group 2.
16140644|NCT01854099|Biological|PEP-CMV|500 µg of PEP-CMV vaccine given intradermally on day 22-24 of each monthly TMZ cycle (dose-intensified 100 mg/m^2 x 21 days) with group 3.
16140645|NCT01854086|Other|Questionnaires about compliance and persistence with bisphosphonates treatment|
16140646|NCT01854073|Drug|Hyoscine butyl bromide|
16140647|NCT01854073|Drug|Normal saline|
16140648|NCT01854047|Drug|Dupilumab|Solution for injection, Subcutaneous injection
16140649|NCT01854047|Drug|placebo|Solution for injection, Subcutaneous injection
16140650|NCT01854047|Drug|ICS/LABA therapy|Oral inhalation, Prior therapy with Mometasone furoate /formoterol, budesonide / formoterol, or fluticasone propionate / salmeterol continued at stable dose
16140651|NCT01854047|Drug|Salbutamol/albuterol|Oral inhalation as needed
16140652|NCT01854047|Drug|Levosalbutamol/levalbuterol|Oral inhalation as needed
16140653|NCT01854034|Drug|AUY922|AUY922 administered intravenously once a week at 70mg/m2
16140654|NCT01854021|Procedure|intravenous anesthesia|intravenous anesthesia
16140655|NCT01854021|Procedure|combined intravenous-inhalational anesthesia|combined intravenous-inhalational anesthesia
16140656|NCT01854021|Procedure|inhalational anesthesia|inhalational anesthesia
16140657|NCT01854008|Other|rehabilitation more the urban circuit|"included in a standard rehabilitation program + the urban circuit. A total of 32 urban walking circuits were developed jointly with the town hall of Mataró(124,000 in habitants)and were included in a triptych called A PEU, FEM SALUT! Itineraris urbans per Mataró http://www.mataro.cat/web/portal/ca/salut/salut_publica/itineraris/index"
16140658|NCT01854008|Other|rehabilitation program but not given urbane circuits|Only rehabilitation program and general recommendations on physical activity and lifestyle . No urbans circuits.
16140659|NCT01853995|Device|Fixed Lingual Mandibular Growth Modificator (FLMGM)|New Class II Corrector
16140660|NCT01853982|Drug|Ceftolozane/Tazobactam|
16140661|NCT01853982|Drug|Piperacillin/Tazobactam|
16140662|NCT01853969|Other|Typing assessment|
16140663|NCT01853956|Drug|Alprazolam 0.25 mg|Reference product
16140664|NCT01853956|Drug|Alprazolam 0.25 mg|Test product
16140665|NCT01853930|Behavioral|Platform for Administering Eye-movement Control Training|The Platform for Administering Eye-movement Control Training (PAECT) meta program will incorporate all of the exercises that the investigators have developed and validated over the course of our previous Merit Review grants (Seiple, Szlyk et al., 2005, 2011). The PAECT platform will be designed to allow patients to easily run the training exercises in their homes and to practice at their convenience. The PAECT will employ an executive component that will keep track of the exercises that are practiced and record performance. Each time a subject opens the platform, it will choose the exercise for that subject based upon previous training and performance.
16140666|NCT01853917|Other|questionaires and structured interviews|We will do questionaires on pregnant women before they have their baby and after they have their baby. We will do structured interviews after they have their baby
16140667|NCT01853904|Procedure|Bronchoscopy/ BAL with Channel Suction|The wall suction used for the channel suction will be set at 80 mm Hg. This arm is for patients who will receive channel suction first to obtain the specimen then syringe suction to obtain the specimen.
16140668|NCT01853904|Procedure|Bronchoscopy/BAL with Syringe Suction|Syringe based suctioning will be performed with 20mL syringe.
16140669|NCT01853891|Other|dim light at night|
16140670|NCT01853878|Biological|Recombinant PRAME protein combined with the AS15 Adjuvant System GSK2302032A|Intramuscular administration
16140671|NCT01853878|Biological|Placebo|Intramuscular administration
16140672|NCT01853865|Other|Instruction in self-referral|
16140673|NCT01853852|Drug|GR181413A/AT1001 solution|Powder for reconstitution
16140674|NCT01853852|Drug|GR181413A/AT1001 capsule|Size 2, hard gelatin capsule, white opaque / blue opaque
16140675|NCT01853852|Other|Potable water|Matched, Size 2, hard gelatin capsule, white opaque/blue opaque
16140676|NCT01853852|Drug|Placebo capsule|Solution matched
16140677|NCT01853826|Drug|afatinib|Patients will receive afatinib once daily
16140678|NCT01853813|Drug|Bevacizumab and FOLFIRI|"The CENTRAL trial is a biologically enriched prospective phase II clinical trial in which patients treated with first-line modified FOLFIRI and bevacizumab will be prospectively stratified according to LDH serum levels.
~After written informed consent patients will be enrolled. Patients will be considered evaluable for study aim if response rate was radiologically evaluated at least once during treatment course.
~Treatment will be administered until progression, patients' withdrawal of consent, unacceptable toxicity"
16140679|NCT01853800|Drug|Rivaroxaban (Xarelto, BAY59-7939)|
16140680|NCT01853787|Drug|Formoterol Fumarate|Formoterol Fumarate, one inhalation of 12 mcg via MDI (Metered Dose Inhaler) Modulite will be taken in double blind randomized way immediately after T0 evaluation.
16140681|NCT01853787|Drug|Salmeterol|Salmeterol 50 mcg via MDI (Metered Dose Inhaler), one inhalation only, immediately after T0 evaluation
16140682|NCT01853774|Behavioral|Tailored navigation|
16140683|NCT01853761|Device|Exercise after|"Aerobic exercise just after microcurrent in the abdominal region, intensity below the sensivity threshold and a maximum of 1 mA.
~30 minutes of aerobic moderate-intensity exercise (50%VO2 max) using Karvonen´s formula, performed on a cycloergometer. Were used Borg scale (12-13) and Polar® heart monitors to control heart rate."
16140684|NCT01853761|Device|Exercise at same time|"Aerobic exercise at the same time microcurrent in the abdominal region, intensity below the sensivity threshold and a maximum of 1 mA.
~30 minutes of aerobic moderate-intensity exercise (50%VO2 max) using Karvonen´s formula, performed on a cycloergometer. Were used Borg scale (12-13) and Polar® heart monitors to control heart rate."
16140685|NCT01853761|Device|Transcutaneos|Microcurrent device in the abdominal region with four transcutaneous electrodes in a parallel position, intensity below the sensivity threshold and a maximum of 1 mA.
16140686|NCT01853761|Device|percutaneous microcurrent|Microcurrent device in the abdominal region with four percutaneous electrodes in a parallel position, intensity below the sensivity threshold and a maximum of 1 mA.
16140687|NCT01853761|Device|25-10Hz|microcurrent device in the abdominal whith intensity below the sensivity threshold and a maximum of 1 mA. Every 15 minutes changed from 25Hz to 10 Hz.
16140688|NCT01853761|Device|25-50Hz microcurrent|microcurrent device in the abdominal whith intensity below the sensivity threshold and a maximum of 1 mA. Every 15 minutes changed from 25Hz to 50 Hz.
16140689|NCT01853748|Drug|Trastuzumab|
16140690|NCT01853748|Drug|Paclitaxel|
16140691|NCT01853748|Drug|Trastuzumab emtansine|
16140692|NCT01853722|Drug|DCN01|Three serial applications per periocular region.
16140693|NCT01853722|Drug|Unisol|Three serial applications per periocular region.
16140694|NCT01853709|Behavioral|Education|
16140695|NCT01853709|Other|Fiber free diet|
16140696|NCT01853709|Dietary Supplement|Adjuvants|
16140697|NCT01853709|Drug|Polyethylene glycol (PEG)|
16140698|NCT01853709|Drug|Bisacodyl|
16140699|NCT01853696|Drug|loteprednol etabonate|
16140700|NCT01853696|Drug|prednisolone acetate 1%|
16140701|NCT01853683|Procedure|Conservative Management|
16140702|NCT01853683|Procedure|Operative Management|
16140703|NCT01853670|Radiation|concurrent chemo + IGRT|
16140704|NCT01853670|Radiation|neoadjuvant chemo + IGRT|
16140705|NCT01853657|Other|Virological monitoring|
16140706|NCT01853644|Drug|Tivozanib|1.5 mg Given PO (orally)days 1-21 or every 28 day cycle
16140707|NCT01853631|Biological|CD19 CAR T Cells|"Group 1: CD19.CAR/28137ζ at 1×10^6 cells/m^2 and CD19.CAR/28ζ at 1×10^6 cells/m^2
~Group 2: CD19.CAR/28137ζ at 5×10^6 cells/m^2 and CD19.CAR/28ζ at 5×10^6 cells/m^2
~Group 3: CD19.CAR/28137ζ at 2×10^7 cells/m^2 and CD19.CAR/28ζ at 2×10^7 cells/m^2"
16140708|NCT01853631|Drug|Fludarabine|3 daily doses of fludarabine (30 mg/m2) will be administered finishing at least 24 hours before T cell infusion.
16140709|NCT01853631|Drug|Cyclophosphamide|3 daily doses of cyclophosphamide (500 mg/m2/day) will be administered finishing at least 24 hours before T cell infusion.
16140710|NCT01853618|Drug|Tremelimumab|3.5 mg/kg or 10 mg /kg intravenous (IV) every 4 weeks times 6 doses and then every 12 weeks for 2 years
16140711|NCT01853618|Procedure|RFA|Performed on Day 36
16140712|NCT01853618|Procedure|TACE|Performed on Day 36 and may be repeated (as per standard of care) on months 3, 7, and 13, and every (q)6 months thereafter (if indicated)
16140713|NCT01853618|Procedure|Cryoablation|Performed on Day 36
16140714|NCT01853605|Device|Anatomically shaped silicone gel-filled breast implants|Surgical implant
16140715|NCT01853579|Drug|Levothyroxine|The intervention will start with Levothyroxine 50 µg daily (reduced to 25 µg in subjects <50Kg body weight or if known coronary heart disease - previous myocardial infarction or symptoms of angina pectoris) versus matching placebo; at 3 months if the serum TSH level is <0.4 mU/L dose will be reduced by 25 µg; TSH >=0.4 and <4.6 mU/L, no change to dose; TSH >=4.6mUL, additional 25 µg. The process will be repeated at 12 months then annually. Mock titration will be performed in the placebo group. The maximum possible dose of Levothyroxine that will be prescribed is 150μg (after 4 increments of 25μg at 3 months, 1, 2 and 3 years; from the starting dose of 50μg).
16140716|NCT01853579|Drug|Placebo|"Control patients will obtain a placebo pill of the same characteristics as the intervention drug, and mock titration will be carried out identically to the intervention drug.
~Pharmaceutical composition of placebo (100 mg): Lactose monohydrate 66 mg, Maize starch 25 mg, Gelatin 5 mg, Croscarmellose sodium 3.5 mg, Magnesium stearate (vegetable source) 0.5 mg."
16140717|NCT01853566|Drug|growth hormone|GH group intervention: use of GH - initial dose of 0.5 UI/day (0.2 mg/day), with readjustments to 1.0 UI/day (0.4 mg/day) and 1.5 UI/day (0.6 mg/day) after 1 and 2 months of treatment, respectively. The last GH dose will be maintained until the end of the study. These GH dosages were based on the dose used for adults of the same age with GHD. Subjects will be re-evaluated after 6 months of GH therapy or placebo according to muscle strength and body composition .The other group received placebo using the same scheme as the GH group.
16140718|NCT01853553|Drug|Spironolactone|Blood pressure medication.
16140719|NCT01853553|Drug|Sugar pill|Placebo.
16140720|NCT01853540|Drug|Sildenafil|
16140722|NCT01853488|Radiation|DXA|Osteodensitometry
16140723|NCT01853488|Radiation|pQCT|Osteodensitometry
16140724|NCT01853475|Drug|PQP tablets 960mg|Piperaquine phosphate tablets 960mg
16140725|NCT01853475|Drug|PQP tablets 1440mg|Piperaquine phosphate tablets 1440mg
16140726|NCT01853475|Drug|OZ439+TPGS 800mg|OZ439+TPGS prototype formulation 800mg
16140727|NCT01853475|Drug|OZ439 PIB 800mg|OZ439 Powder in Bottle Aqueous Solution 800mg
16140728|NCT01853462|Other|PNF training|Ten individual PNF sessions, supervised by a physical therapist, with 50-60 min duration per session, within a maximal five-week period
16140729|NCT01853462|Other|Balance training|Ten individual balance sessions, supervised by a physical therapist, with 50-60 min duration per session, within a maximal five-week period
16140730|NCT01853449|Drug|Fentanyl Citrate|
16140731|NCT01853449|Other|CWS|Chest wall strapping to reduce vital capacity by 20% of its baseline value
16140732|NCT01853449|Drug|Placebo|0.9% saline
16140733|NCT01853436|Device|Strattice™ Reconstructive Tissue Matrix|Experimental arm: Device: Strattice Reconstructive Tissue Matrix Unilateral or bilateral mastectomy. Immediate breast reconstruction with sub-pectoralis muscle placement of a breast implant with ADM, single stage reconstruction technique. Control arm: Device: no device. Immediate breast tissue expander/implant based reconstruction with a two-stage reconstruction technique.
16140734|NCT01853423|Drug|Rapamune|Small amount of 0.1% rapamune ointment applied topically to affected facial areas twice daily for the first two weeks, then once daily.
16140735|NCT01853410|Device|gekoTM|
16140736|NCT01853397|Device|Liposonix System (Model 2)|
16140737|NCT01853384|Biological|HP802-247|Study Dosage / Usage: 260 µL (130 µL, one spray, of each solution) containing 0.5 X 10(6th) cells per mL every 14 days.
16140738|NCT01853384|Other|HP802-247 Vehicle|HP802-247 Vehicle consists of two separate components, a fibrinogen solution (Component 1) and a cell free thrombin solution which is identical to Component 2 except that no keratinocytes and no fibroblasts are present. A single dose is created when combined on the wound surface.
16140739|NCT01853371|Procedure|Wet cupping|Wet cupping is the process of using a vacuum at different points on the body in order to gather the blood in that area. Then apply few superficial incisions (small, light scratches using a razor) on those areas, followed by repeating the vacuum on the same areas in order to remove 'harmful' blood which lies just beneath the surface of the skin. In this study, the wet cupping procedure was not done on certain days of the lunar month.
16140740|NCT01853371|Other|Conventional treatment|According to Saudi Hypertension management guidelines, hypertension patients may require life style modification alone , especially for newly diagnosed cases, or my require life style modification and drug treatment. This will be decided by the treating team in the hospital.
16140741|NCT01853358|Biological|NK Cell infusion|"level 1: 1 x 10e6 NK cells /kg;
~level 2: 5 x 10e6 NK cells /kg;
~level 3: > 5.10e6 and ≤ 5.10e7 cellules NK/kg"
16140742|NCT01853319|Drug|Regorafenib (Stivarga, BAY73- 4506)|160 mg regorafenib per oral every day for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off)
16140743|NCT01853306|Drug|Veliparib|veliparib
16140744|NCT01853293|Drug|Kudzu extract|
16140745|NCT01853293|Drug|Placebo|
16140746|NCT01853293|Behavioral|Medical Management|Medical Management is a manualized treatment deriving from a number of empirically tested manualized therapies designed to approximate a primary care approach to alcohol dependence. The treatment, delivered by a medical professional (i.e., nurse or physician), monitors medication side effects, provides strategies to increase medication adherence and supports abstinence through psychoeducation and referral to groups such as Alcoholics Anonymous. The visits allow for assessments of drinking, overall functioning, medication adherence, and side effects. Also at one of these weekly visits, a blood sample will be taken for liver function tests (GGT, ALT, AST). Samples will be further analyzed for two measures of heavy drinking: carbohydrate deficient transferrin (CDT) and phosphatidylethanol (PEth).
16140747|NCT01853280|Drug|L-methylfolate|15mg/day L-methylfolate.
16140748|NCT01853280|Drug|OROS-Methylphenidate|All subjects will be treated with open-label OROS-MPH
16140749|NCT01853280|Drug|Placebo|15 mg matched placebo comparator, with open-label OROS-Methylphenidate
16140750|NCT01853267|Procedure|Intervention Group (Non-Packing)|The haemostatic pack placed in the perianal abscess cavity will be removed on discharge and the wound will be left to heal without packing in situ
16140751|NCT01853267|Procedure|Control group (Packing)|After the procedure the abscess cavity will be packed with a non-adherent dressing as per standard treatment and the packing changed at regular intervals in the community until healing by secondary intention is complete.
16140752|NCT01853254|Drug|Peginterferon alfa-2a|Both combination and monotherapy for both genotype 2/3 and genotype non-2/3: 180 μg subcutaneously once weekly.
16140753|NCT01853254|Drug|Ribavirin|For genotype 2/3, 800 mg orally daily, in 2 split doses for 24 weeks. For genotype non-2/3, 1000 mg orally daily for participants weighing < 75 kg or 1200 mg orally daily for participants weighing ≥ 75 kg, in 2 split doses, for 48 weeks.
16140754|NCT01853241|Procedure|Single Balloon|All patients in this group will undergo single balloon enteroscopy
16140755|NCT01853241|Procedure|Spirus|All patients in this group will undergo Spirus Enteroscopy
16140756|NCT01853228|Drug|Phase1 and Phase 2: decitabine|20 mg/m2 administered by intravenous infusion over 1 hour once daily for 5 consecutive days (Day 1 to Day 5 of 28-day cycle)
16140757|NCT01853228|Drug|Phase 1: cytarabine|1 g/m2, 2 g/m2, and 1.5 g/m2 dose levels administered by intravenous infusion over 4 hours daily for 5 consecutive days (Day 8 to Day 12 of 28-day cycle) for the determination of the maximum tolerated dose
16140758|NCT01853228|Drug|Phase 2: cytarabine|Phase 1 maximum tolerated dose administered by intravenous infusion over 4 hours daily for 5 consecutive days (Day 8 to Day 12 of 28-day cycle)
16140759|NCT01853215|Device|T.A.L.O.N. Intraosseous System|intraosseous catheter for use in the sternum
16140760|NCT01853202|Behavioral|Supervised aerobic exercise training|
16140761|NCT01853189|Other|OMT + Usual Care|patients from this group received 6 sessions of OMT
16140762|NCT01853189|Other|Usual Care|patients from control group received standard care + osteopathic evaluation only, according to the same schedule of the study group
16140763|NCT01853176|Drug|Liposomal Injection Bupivacaine (Exparel)|
16140764|NCT01853176|Drug|Standard bupivicaine|
16140765|NCT01853163|Procedure|Gadolinium analysis in bone and tissue samples|Gadolinium analysis in bone and tissue samples from patients undergoing an orthopaedic surgical procedure who had received Gadolinium-containing contrast agents in the past.
16140766|NCT01853150|Device|rTMS Motor cortex|
16140767|NCT01853150|Device|rTMS Supplementary motor area|
16140768|NCT01853137|Device|Fixed Lingual Mandibular Growth Modificator (FLMGM)|Novel Class II functional appliance, a fixed version of double-plate appliance
16140769|NCT01853124|Drug|Placebo|All patients in this arm of the study will take 1 sachet containing inactive ingredients (maltodextrin, magnesium stearate, and ascorbic acid) twice daily for 5 days. Doses should be ideally separated by 12 hours (minimum of 8 hours) and taken within 30 minutes of food/drink. If the child vomits within 15 minutes of medication administration (initial or subsequent dose), the dose will be repeated. Total of 2 sachets per day for 5 days.
16140770|NCT01853124|Drug|Lacidofil|All patients in this arm of the study will take 1 sachet twice daily for 5 days. Each sachet will contain a minimum of 4 billion colony-forming units (CFU) of Lactobacillus rhamnosus Rosell-11 (95%) and L. helveticus Rosell-52 (5%). The total weight of all ingredients is 1 gm. Doses should be ideally separated by 12 hours (minimum of 8 hours) and taken within 30 minutes of food/drink. If the child vomits within 15 minutes of medication administration (initial or subsequent dose), the dose will be repeated. Total daily dose = 8 billion CFU x 5 days.
16140771|NCT01853111|Biological|Interleukin-2|
16140772|NCT01853098|Behavioral|Positive Affect Training (PAT)|During the PAT sessions, the participants will be taught the basics of mindfulness and how to concentrate their thoughts and feelings on the present moment in a non-judgmental fashion. As the therapy sessions continue, participants will be introduced to basic loving-kindness meditation (LKM). They will be taught to identify and focus the positive feelings they have when they are around someone or something they care about, and transfer these feelings first to themselves, then to a close friend, to a neutral individual, to people whom they dislike, and finally to all living beings.
16140773|NCT01853085|Drug|Bimatoprost Ophthalmic Solution|Patients with primary open angle glaucoma (POAG) or ocular hypertension (OHT) treated with Lumigan® UD (bimatoprost ophthalmic solution) administered in accordance with physician standard practice for up to 12 weeks.
16140774|NCT01853072|Drug|Nepafenac Ophthalmic Suspension, 0.3%|Test intervention
16140775|NCT01853072|Other|Nepafenac vehicle|Inactive ingredients used as placebo comparator
16140776|NCT01853072|Drug|Prednisolone acetate|1 drop instilled in the operative eye 4 times daily beginning post-operatively on the day of surgery for the first 2 weeks, followed by 2 times daily for the next 2 weeks
16140777|NCT01853046|Drug|Regorafenib (Stivarga, BAY73-4506)|Regorafenib 160 mg o.d. will be administered as a single dose on Day 1 of Stage 1 followed by multiple dosing in an intermittent administration schedule (3 week-on/1 week-off) over 2 cycles in Stage 2 (56 days, cycle defined as 28 days)
16140778|NCT01853033|Biological|ABT-122|Injection
16140779|NCT01853033|Biological|Placebo|Placebo Injection
16140780|NCT01853020|Drug|THC|"Very low dose (0.0015 mg/kg = 0.21 mg in a 70 kg individual) THC, dissolved in alcohol. Administered intravenously over 10 minutes.
~Low Dose (0.015 mg/kg = 1.05 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately ¼ of a marijuana cigarette, or joint. Administered intravenously over 10 minutes.
~Medium dose (0.03 mg/kg = 2.1 mg in a 70 kg individual) THC, dissolved in alcohol. This dose is roughly equivalent to smoking approximately ½ of a marijuana cigarette, or joint. Administered intravenously over 10 minutes."
16140781|NCT01853020|Drug|Placebo|Control: small amount of alcohol intravenous (quarter teaspoon), with no THC over 10 minutes.
16140782|NCT01853007|Behavioral|COACH Program|
16140783|NCT01852994|Drug|Testosterone replacement|Application quarterly of Testosterone Undecylate
16140784|NCT01852994|Other|Exercise training|Aerobic and strength exercise training
16140785|NCT01852981|Behavioral|Lifestyle counseling|Strategies consisted of group discussion, some physical activities, phone support, and printed materials. The content and strategies were elaborated by a team formed by a doctor, nutritionists, a psychologist, and physical education professionals and the main aim was to promote the engagement in physical activity, working not only on behavioral change but also on the environment attributes available for physical activity practice. The main strategy was the group discussion, which sessions lasted 120 minutes each and its frequency changed as follow: in the first month they were weekly; in the second occurred twice per month; and in the third month onwards sessions were monthly. All sessions occurred in the Primary Health Unit or inside a community association building.
16140786|NCT01852981|Behavioral|Supervised exercise|Supervised exercise program in groups. Individuals in this program participated in three weekly structured and supervised sessions of aerobic, strength, and stretching exercises, drawn up in accordance to the American College of Sports Medicine recommendations. Load, intensity, and exercise adjustments were made during the program. All sessions lasted 60 minutes each and occurred in a gymnasium nearby the Primary Health Unit.
16140787|NCT01852955|Drug|IV acetaminophen|Administration of IV acetaminophen 1000 mg over 15 minutes at the start of surgical closure
16140788|NCT01852955|Drug|Placebo|Administration of placebo (sterile normal saline)group-same volume of saline solution administered in the same fashion as the acetaminophen
16140789|NCT01852942|Drug|Losartan|Participants will start with 50 mg of losartan by mouth daily. The dose will be increased to 100 mg by mouth daily after 14 days. The maximal tolerable dosage (up to 100mg by mouth daily) will be continued for a total of 30 months.
16140790|NCT01852942|Drug|Placebo|one tablet by mouth daily
16140791|NCT01852929|Other|Subject using usual positive airway pressure therapy while sleeping for one night|Participants use their usual positive airway pressure therapy while sleeping overnight
16140792|NCT01852916|Device|CPAP|Nasal Continuous Positive Airway Pressure Ventilation using Infant Flow CPAP machine
16140793|NCT01852916|Device|NHFOV|Nasal High Frequency Oscillatory Ventilation
16140794|NCT01852903|Dietary Supplement|calcium ascorbate|
16140795|NCT01852903|Dietary Supplement|ascorbic acid|
16140796|NCT01852903|Other|placebo|
16140797|NCT01852890|Drug|Ascorbate|Intravenous infusion of high-dose ascorbate
16140798|NCT01852890|Drug|Gemcitabine|Intravenous chemotherapeutic
16140799|NCT01852890|Radiation|Radiation therapy|
16141060|NCT01850784|Dietary Supplement|Standard formula|The infants with CHD will be fed with standard formula (0.6-0.7 kcal/ml)
16140800|NCT01852877|Behavioral|Corrections case management|Corrections case management is a long-term (18-24 months) program that seeks to improve the linkage of HIV-positive persons recently released from jail or prison to community-based HIV care, retain them in care, and reduce recidivism. Compared to the long-standing Ryan White case management program, corrections case management has greater access to housing and a greater emphasis on employment. Clients completing the program are then linked to the Ryan White case management program.
16140801|NCT01852864|Drug|240mg degarelix s.c. injection|7 days prior to radical prostatectomy the patient will have a subcutaneous injection of 240mg degarelix.
16140802|NCT01852851|Behavioral|Employment and Arthritis: Making it Work|A ten week on-line eLearning program designed to help people with inflammatory arthritis stay employed. The program consists of 1) 5 interactive web-based eLearning modules that participants will complete individually in between the weekly group sessions, 2) 5 weekly group sessions conducted as virtual real-time web-based group meetings led by a trained facilitator, 3) asynchronous communications such as a message board to facilitate additional interactions among participants, 4) consultations with an occupational therapist (in-person)for an ergonomic assessment, and a vocational rehabilitation counsellor (on-line consultation using web technology) for job retention vocational counselling.
16140803|NCT01852825|Biological|MK-8237|A single tablet of MK-8237 with 12 DU, administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
16140804|NCT01852825|Other|Placebo|A single placebo tablet administered sublingually, at approximately the same time each day for 84 days (+/- 5 days)
16140805|NCT01852825|Biological|NAC|0.1 mL fixed volume of 10,000 BU/mL of HDM extract is delivered with a Pfeiffer Bidose Nasal Delivery System (or equivalent) to each nostril for a total dose of 1800 BU at the start of Part 1; and in Part 2 on Days -14, 56 and 84
16140806|NCT01852812|Drug|Montelukast Oral Granules (OG)|Montelukast 4 mg in one sachet
16140807|NCT01852812|Drug|Montelukast Chewable Tablets (CT)|Montelukast 5 mg in one tablet
16140808|NCT01852799|Drug|PAD Followed by ASCT|"Drug: Bortezomib, Bortezomib (1.3mg/m2, iv, on day 1, 4, 8, 11, of each 28 day cycle)
~Drug: Adriamycin (Doxorubicin) /EPI, Adriamycin (Doxorubicin) (9 mg/m2, iv, on days 1-4 of each 28 day cycle) or EPI (15mg/m2, iv, on days 1-4 of each 28 day cycle)
~Drug: Dexamethasone, Dexamethasone (20mg, iv, on days 1-4, 8-11of each 28 day cycle)
~After received induction therapy, patients will proceed to receive ASCT based on the willing of the patients and the decision of the investigators."
16140809|NCT01852786|Other|Contraceptives, Oral, Combined|• The women, presenting for hormonal contraception use and with no contraindications for hormonal therapy, one of the two medicines registered in Lithuania will be administered׃ Daylette (20 micrograms of Ethinylestradiol and 3 mg of Drospirenone) or Lindynette (20 micrograms of Ethinylestradiol and 75 micrograms of Gestoden).
16140810|NCT01852786|Other|Controls|The women, The women presenting for non-hormonal contraception use, will be recommended BCM or NFPM.
16140811|NCT01852773|Procedure|Open repair of thoracic aorta injury|open surgical management of aortic injury
16140812|NCT01852773|Procedure|TEVAR|Use of endovascular (minimally invasive) techniques for repair of aortic injury
16140813|NCT01852747|Procedure|Multilevel Spinal fusion with Actifuse ABX®|Multilevel spinal fusion as treatment for adult spinal deformity with Actifuse ABX®. Actifuse ABX® is a silicate substituted calcium phosphate bone void filler intended for orthopedic applications such as a filler for gaps and voids that are not intrinsic to the stability of the bony structure.
16140814|NCT01852734|Procedure|embolizations ,uterine fibroid|"26 patients will be treat with Bead-block microspheres, 500-700 and 700-900µm until flow stop (  cut the tree appearance)
~26 patients will be treat with Embosphere, 500-700µm and /or 700-900 until near stasis  flow stop"
16140815|NCT01852734|Procedure|embolizations|comparison between the two microspheres
16140816|NCT01852721|Behavioral|Experimental: Men and Mediterranean diet|The 12-week nutritional education program will include 3 group sessions with 8-12 participants per group. During the 1st group session, the registered dietitian (RD) will explain the major principles of the Mediterranean diet (MedDiet) and related heath benefits. At week 4, subjects will be invited to a Mediterranean cooking lesson. At week 8, the group session will address barriers and difficulties in adhering to the recommendations. Individual sessions will take place at weeks 1, 5 and 10 in order to evaluate the dietary changes and to select further individualized objectives for increasing the adherence to the MedDiet. The RD will encourage participants to make their own decision about changes while promoting their autonomy and competence. Qualitative 24-h recalls will be performed by telephone at weeks 3, 6, 9 and 12 to reinforce key principles of the MedDiet. No further contact with the RD will be offered during the follow-up period.
16140817|NCT01852721|Behavioral|Experimental: Women and Mediterranean diet|Women are assigned to the same intervention than men in order to compare men and women adherence to the Mediterranean diet.
16140818|NCT01852695|Behavioral|Family Integrated Care|Parents are integrated into the care of their infants in the NICU. Parents consent to spending up to eight hours a day with their infant, attend special education sessions, participate in daily medical rounds, and do basic infant charting. This will enable parents to provide care for infants with nursing supervision in the areas of feeding, bathing, dressing and holding skin to skin.
16140819|NCT01852682|Drug|PA21|
16140820|NCT01852669|Procedure|Inversion|Patients inverted 30 degree head down in Trendelenburg position
16140821|NCT01852669|Procedure|Shock Wave Lithotripsy|Shock wave lithotripsy
16140822|NCT01852669|Drug|Hydration|Hydration of patient with 0.5L NaCl and 20mg frusemide IV
16140823|NCT01852656|Behavioral|Postcard and IVR Reminder Group|"IVR: Subjects in this reminder group will receive an automated telephone call to their primary telephone number. A total of 2 call attempts per member will be made. The IVR system will provide a message about the importance of annual influenza vaccination. The member can also request additional information about influenza vaccination and influenza vaccination locations and times.
~Postcard: The postcard will be sent as a single postcard to each individual on the list. The postcard will be sent to the home address of the member. If the postcard is returned, the postcard will not be re-sent. The postcard does not identify that the member has a chronic health condition such as asthma or COPD. The postcard will be mailed during the last two weeks of September, 2012."
16140899|NCT01852136|Device|BD NEXT 32G x 4mm pen needle|Each pen needle type will be used for approximately one week. Subjects will use their current pen injector device.
16140900|NCT01852123|Device|High-sensitivity troponin I assay|
16140901|NCT01852110|Drug|MK-7622|MK-7622 capsule
16140824|NCT01852656|Behavioral|Postcard Only Reminder Group|Postcard: The postcard will be sent as a single postcard to each individual on the list. The postcard will be sent to the home address of the member. If the postcard is returned, due to an inaccurate address, the postcard will not be re-sent. The postcard does not identify that the member has a chronic health condition such as asthma or COPD. The postcard will be mailed during the last two weeks of September, 2012.
16140825|NCT01852656|Behavioral|IVR Only Reminder Group|IVR: Subjects in this reminder group will receive an automated telephone call to their primary telephone number. A total of 2 call attempts per member will be made. The IVR system will provide a message about the importance of annual influenza vaccination. The member can also request additional information about influenza vaccination and influenza vaccination locations and times.
16140826|NCT01852643|Procedure|Spreader graft|Spreader graft technique is performed by a group of expert surgeons.
16140827|NCT01852643|Procedure|Lateral crural overlay|Lateral crural overlay technique is performed by a group of expert surgeons.
16140828|NCT01852630|Drug|cefepime + Albumin|cefepime + Albumin will be given for 2 days
16140829|NCT01852630|Drug|Imipenem + Albumin|Imipenem + Albumin will be given for 2 days.
16140830|NCT01852617|Behavioral|Training in smoking cessation counseling|"Midwife facilitators in the intervention clinics will be identified and trained to deliver the 5 A's to pregnant women and will then disseminate and implement the program. The 5 A's (Ask, Advise, Assess, Assist, Arrange) is a strategy consisting of a brief cessation counseling session of 5-15 minutes delivered by a trained provider, which is considered the standard of care worldwide"
16140831|NCT01852604|Drug|Samatasvir|Samatasvir (IDX719) will be supplied as 25 mg and 50 mg oral tablets.
16140832|NCT01852604|Drug|Simeprevir|Simeprevir will be supplied as 75 and 150 mg oral capsules.
16140833|NCT01852604|Drug|Ribavirin (RBV)|Ribavirin will be supplied as 200 mg oral tablets. Participants in the RBV-free arms experiencing non-response or virologic breakthrough during the treatment period will be offered RBV dosed according to the product label as an add-on to the participant's randomized treatment assignment.
16140834|NCT01852604|Drug|TMC647055|TMC647055 will be supplied as 150 mg oral capsules.
16140835|NCT01852604|Drug|Ritonavir (RTV)|Ritonavir will be supplied as 80 mg/mL oral solution.
16140836|NCT01852604|Biological|Pegylated interferon (Peg-IFN)|Participants experiencing non-response or virologic breakthrough during the treatment period will be offered Peg-IFN (subcutaneous injection) dosed according to the product label as an add-on to the participant's randomized treatment assignment.
16140837|NCT01852604|Other|Samatasvir matching placebo|Samatasvir matching placebo will be supplied for the 50 mg tablets used in Part A.
16140838|NCT01852591|Biological|PCV 13|
16140839|NCT01852578|Drug|Cabazitaxel|Cabazitaxel: 25 mg/m² i.v over 1 h on day 1. Cycles repeated ever 3 weeks
16140840|NCT01852565|Drug|Darapladib|Enteric coated, free base (micronized) white round tablet, 160mg, Oral/repeat dose/10 days (Treatment Period 1), 14 days (Treatment Period 2)
16140841|NCT01852565|Drug|Diltiazem|Extended release, Blue capsule imprinted with cardizem CD and 240mg on one end, 240 mg, Oral/repeat dose/17 days
16140842|NCT01852552|Device|transcatheter aortic valve implantation|Patients undergoing TAVI with transfemoral, transapical, or any other vascular access
16140843|NCT01852552|Procedure|Aortic Valve Replacement|Surgical AVR, with all kind of commercially available prosthesis (stented, stentless, mechanical)
16140844|NCT01852539|Drug|dexmedetomidine|The dose of dexmedetomidine was determined by modified Dixon's up-and-down method, starting from 0.5 μg/kg (0.1 μg/kg as a step size).
16140845|NCT01852539|Drug|propofol|Propofol 2.0 mg/kg was administrated
16140846|NCT01852539|Device|laryngeal mask airway (LMA)|The insertion of laryngeal mask airway (LMA) was attempted, after confirming the loss of eyelash reflex,the bispectral index (BIS) score decreased below 60.
16140847|NCT01852526|Device|Experimental: hybrid system|The intervention group will receive a hybrid system with PLIF and a flexible pedicle screw system above the fusion. Surgery will be performed using the following devices (Dynamic Rod® Hersteller: AESCULAP AG, Tuttlingen
16140848|NCT01852526|Device|Active Comparator: Plif|monosegmental PLIF
16140849|NCT01852513|Drug|QNASL|
16140850|NCT01852513|Drug|Placebo nasal spray|
16140851|NCT01852500|Other|Sham Osteopathic Manipulative Treatment|Patients from this group received sham osteopathic treatments twice a week for the entire length of stay in the unit.
16140852|NCT01852500|Other|Standard care|Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.
16140853|NCT01852487|Dietary Supplement|400mg /day during 6 months|
16140854|NCT01852474|Device|Transcranial Direct Current Stimulation (tDCS)|Subjects will receive tDCS stimulation 1x per day for 5 days (over the period of 1 week). Each session will be 20 minutes long. The subject will receive active stimulation for the entire 20 minutes.
16140855|NCT01852461|Drug|Beractant|Beractant;both initial and subsequent dosing is 100 mg/kg (4 mL/kg), which may be given every 6 hours up to four total doses
16140856|NCT01852461|Drug|Poractant alfa|porcine lung extract, initial dosing is 200 mg/kg (2.5 mL/kg) and repeated dosing is given at 100 mg/kg (1.25 mL/kg) every 12 hours, up to maximum of two additional doses when indicated
16140857|NCT01852448|Genetic|Blood or Saliva Sample Collection|A blood or saliva sample will be obtained for genotyping of TCF7L2 and approximately ten other genes implicated in type 2 diabetes.
16140858|NCT01852448|Other|Glucose -potentiated arginine (GPA) stimulation tests|Glucose -potentiated arginine (GPA) stimulation tests and mixed meal tolerance tests (MMTT) will be performed on two separate days in the outpatient setting.
16140859|NCT01852435|Drug|R-CEOP-70|
16140860|NCT01852435|Drug|R-CEOP-90|
16140861|NCT01852435|Drug|R-CHOP-50|
16140862|NCT01852409|Drug|bevacizumab|
16140863|NCT01852396|Procedure|Retroclavicular block|Retroclavicular approach ultrasound guided regional anesthesia
16140902|NCT01852110|Drug|Placebo|Matching placebo to MK-7622 capsule
16140903|NCT01852110|Drug|AChEI|"One of the following AChEIs, as prescribed by the participant's primary care physician:
~Donepezil: 10 mg total daily dose, administered orally
~Rivastigmine: 9.5 or 13.3 mg/24 hours, administered by transdermal patch; or 6-12 mg total daily dose administered orally
~Galantamine: 16-24 mg total daily dose, administered orally"
16141103|NCT01850407|Behavioral|Education Counseling|
16140864|NCT01852383|Drug|Duloxetine|"Patients were evaluated weekly for the first 6 weeks and every two weeks for the next 6 weeks. At 0, 1, 4, 8, and 12 weeks, the study psychiatrist completed the Cornell Dysthymia Rating Scale , Clinical Global Impression (CGI) scale, and side effect ratings using the Treatment Emergent Symptom Scale. The research rater completed a SCID-P at baseline and the 24-item HAM-D at each visit, and the patient completed the Beck Depression Inventory-II at each visit.
~Adverse events: All adverse events and serious adverse events were documented.
~The maximum duration of delay before active treatment (medication or psychotherapy) was 1 week.
~Dropout: Patients who had a CGI score of 6 or 7 for two weeks during the second half of the study were dropped by the investigator from the trial."
16140865|NCT01852370|Biological|CD3/CD19 negative allogeneic hematopoietic stem cells|Negative selection for CD3/CD19 will be performed on a CliniMACS® depletion device within 36 hours of collection and given at time no less than 8 weeks post lung transplant.
16140866|NCT01852357|Other|Neurofeedback|The intervention will be 24 sessions of beta/sensorimotor rhythm (SMR) neurofeedback.
16140867|NCT01852357|Other|Sham Neurofeedback|Feedback generated by data not associated with the current participant.
16140868|NCT01852344|Drug|Methylphenidate|20 mgs of methylphenidate or placebo to be administered one hour before task performance
16140869|NCT01852344|Drug|Placebo|20 mgs of methylphenidate or a placebo to be administered one hour before task performance
16140870|NCT01852344|Behavioral|Easy Behavioral Task|Subjects do an easy version of the Letter E Task.
16140871|NCT01852344|Behavioral|Hard Behavioral Task|Subjects do a hard version of the Letter E Task.
16140872|NCT01852331|Drug|PGD granules|The preparation of Peony-Glycyrrhiza Decoction (PGD) granules is in compliance with Pharmacopoeia of the People's Republic of China and Good Manufacturing Practice (GMP). Briefly, sliced, broiled Paeoniae Alba Radix and Glycyrrhizae Radix in a ratio of 1:1 in weight will be immersed and boiled in an 8-fold volume of distilled water for 2.5 hours. This process will be repeated twice. The extract solution will be pooled and concentrated into granule form. Weight of the resulting granules contained in two 9g-sachet packs (to be taken in one day) is equivalent to 45 g raw herbal materials which are supplied for one day.
16140873|NCT01852331|Drug|Placebo|The placebo granules are prepared to be identical to PGD granules in smell, taste and color.
16140874|NCT01852318|Drug|pregabalin 75mg daily for 12 weeks|oral pregabalin 75mg daily for 12 weeks
16140875|NCT01852318|Drug|fexofenadine 60 mg daily for 12 weeks|fexofenadine 60 mg daily for 12 weeks
16140876|NCT01852318|Drug|placebo|
16140877|NCT01852305|Other|Lab Sleep Study Group|Patients in this group will under go lab sleep study overnight at the sleep clinic.If the patient has severe sleep apnea (AHI>30) or moderate sleep apnea (AHI>15 to <30) with significant co-morbidities (e.g. cardiovascular disease, diabetes), CPAP treatment will be recommended. For mild sleep apnea (AHI>5 to <15) or moderate sleep apnea without significant co-morbidities, CPAP will not be required. If patient is not able to tolerate or refuses CPAP, dental device and positional therapy will be recommended.
16140878|NCT01852305|Device|Oximetry|The patients in the Oximetry group will undergo overnight pulse oximetry. The patients with ODI>10 events/hour will be referred to the sleep medicine specialist.A split- night PSG will be employed to confirm OSA diagnosis. The 1st part of the night will be a sleep study and depending on AHI, CPAP titration will be done for the 2nd part of the night
16140879|NCT01852292|Drug|Buparlisib|Buparlisib comes in gelatin capsules and is taken orally at a dose of 100 mg/day.
16140880|NCT01852292|Drug|Buparlisib matching Placebo|Buparlisib matching placebo comes in gelatin capsules and is taken orally at a dose of 100 mg/day.
16140881|NCT01852292|Drug|Paclitaxel|Paclitaxel is an intravenous infusion that is given once every week in 80 mg/m^2.
16140882|NCT01852279|Device|BCI-FES|Brain computer Interface delivered Function Electrical Stimulation
16140883|NCT01852279|Device|Passive muscle stimulation|Functional Electrical stimulation delivered by therapist
16140884|NCT01852266|Biological|RSV cps2 Vaccine|10^5.3 plaque forming units (PFUs) of RSV cps2 vaccine will be administered as nose drops (0.25 mL per nostril, for a total of 0.5 mL).
16140885|NCT01852266|Biological|Placebo Vaccine|Placebo vaccine will be administered as nose drops (0.25 mL per nostril, for a total of 0.5 mL).
16140886|NCT01852253|Procedure|2% chlorhexidine|
16140887|NCT01852253|Procedure|0.12% chlorhexidine|
16140888|NCT01852214|Drug|Prasugrel|Patients receiving prasugrel will be treated with 60mg loading dose and 10mg maintenance dose
16140889|NCT01852214|Drug|Ticagrelor|Patients receiving ticagrelor will be treated with a 180mg loading dose and 90mg bid maintenance dose
16140890|NCT01852201|Device|Endovascular Mechanical Thrombectomy|Endovascular intervention can be performed under either general anesthesia or conscious sedation based on best practices as determined by treating physician. Attempt should be made to expedite the transition from imaging to treatment in as rapid a fashion as possible. The subject should be prepared for the planned interventional procedure according to standard hospital procedures. Mechanical revascularization should be performed with the operators standard thrombectomy technique using aspiration or a stent retriever, separately or in combination.
16140891|NCT01852188|Other|Type of glove used for intrapartum vaginal exams|Patients will be randomized to either sterile or clean gloves during intrapartum vaginal exams.
16140892|NCT01852175|Drug|Prasugrel|Prasugrel 60mg loading dose and 10mg maintenance dose
16140893|NCT01852175|Drug|Ticagrelor|Ticagrelor 180mg loading dose and 90mg bid maintenance dose
16140894|NCT01852162|Drug|Dabigatran|Dabigatran 150mg
16140895|NCT01852162|Drug|Placebo|Matching placebo tablets
16140896|NCT01852149|Device|MPAS Implant|The Mitralign System consists of a set of catheters that enable the physician to position and place sutures and anchors through the posterior (back) annulus of the mitral valve under the guidance of echocardiography and fluoroscopy. Once the anchored sutures are in place, the sutures are pulled together. When the valve leaflets are close together, the sutures are locked with at least one stainless steel lock. The Bident Translation Catheter allows implantation of two pairs of pledgets. Each pair of pledgets plicates the annulus and then the pledgets are locked together from the ventricular side with a lock.
16140897|NCT01852136|Device|BD NEXT 31G x 5 mm pen needle|Each pen needle type will be used for approximately one week. Subjects will use their current pen injector device.
16140898|NCT01852136|Device|BD NEXT 31G x 8mm pen needle|Each pen needle type will be used for approximately one week. Subjects will use their current pen injector device.
16140904|NCT01852097|Behavioral|CBT based online intervention to elicit and address perceptual and practical barriers to taking medication.|"The general approach to the intervention is the following:
~Assess and profile individual perceptual and practical barriers to medication for IBD using validated questionnaires.
~Give feedback to individuals on their questionnaire responses.
~Provide individualised advice to address doubts, misconceptions and concerns for currently prescribed medications.
~Provide advice on overcoming practical barriers.
~Send motivational messages (and reminders if applicable) by email or text based on the unique profile of each participant.
~Provide information about how to raise concerns with medical practitioners and how to get the most from a medical consultation."
16140905|NCT01852084|Device|enVista® One-Piece Hydrophobic Acrylic Toric IOL|Test lens having a toric cylinder power of either 1.25 diopters (D), 2.00 D, or 2.75 D
16140906|NCT01852084|Device|enVista control lens|Spherical Control lens
16140907|NCT01852071|Genetic|Infusion of autologous EFS-ADA LV CD34+ (OTL-101)|autologous EFS-ADA LV CD34+ cells (OTL-101) are infused intravenously
16140908|NCT01852071|Drug|busulfan|Busulfan is used for non-myeloablative conditioning
16140909|NCT01852071|Drug|PEG-ADA ERT|PEG-ADA ERT is discontinued at Day +30 (-3/+15 days) after successful engraftment
16140910|NCT01852058|Biological|OnabotulinumtoxinA|OnabotulinumtoxinA injected into the detrusor wall. Treatments were administered as needed with a minimum of a 12-week interval between doses.
16140911|NCT01852045|Biological|OnabotulinumtoxinA|OnabotulinumtoxinA injected into the detrusor wall on Day 1.
16140912|NCT01852032|Radiation|Tomosynthesis Breast Scanning|The breast is positioned and compressed the same way it is in a conventional mammogram using a compression paddle device. The subject will be instructed to hold their breath and not move during the 7- second 3-D tomosynthesis acquisition. The affected breast is positioned with MLO compression. The radiation dose levels for each scan are equivalent to mammography
16140913|NCT01852032|Radiation|Breast CT Scanning|"CT scanning will be performed before and after I.V. iodine contrast injection. The subject will lie prone on a large table (which is covered by a foam pad), and she will place the breast to be scanned in a small hole in that tabletop. The hole is surrounded by a soft neoprene hammock, which will allow the subject's entire upper torso to slump into the scan plane of the device. After positioning of the affected breast by a female mammography technologist, the subject will be instructed to hold their breath for 16 seconds and the pre-contrast scan will commence. There will be no breast compression. Other than the sound of the relatively noisy x-ray system in the room, the subject will not feel or sense any aspect of this scan."
16140914|NCT01852019|Drug|Cangrelor|Cangrelor IV administered as a 30 µg/kg bolus, followed by 4 µg/kg/min infusion for two hours on study Days 1 and 8
16140915|NCT01852019|Drug|Prasugrel|"Day 1: Subjects received prasugrel (60 mg) either during the initial cangrelor infusion (at 1.0 hours or 1.5 hours after infusion start) or within 5 minutes of discontinuing the cangrelor infusion.
~Subjects will be given either 5 or 6 additional 10-mg doses to be taken every 24 hours between Day 1 and Day 8."
16140916|NCT01852006|Device|Abdominal Binder|Abdominal Binding to increase end-expiratory gastric pressure by 5-8 centimetres of water at rest.
16140917|NCT01851993|Drug|Ondansetron|
16140918|NCT01851993|Drug|Placebo|0.9% saline
16140919|NCT01851980|Other|CWS|Chest wall strapping to reduced vital capacity by 20% of its baseline value
16140920|NCT01851980|Drug|Furosemide|40 mg and 120 mg
16140921|NCT01851980|Drug|Placebo|0.9% saline
16140922|NCT01851967|Other|MoodGYM|MoodGYM, a publicly-available online CBT program developed by the Centre for Mental Health Research at The Australian National University has been shown by multiple studies to be effective in reducing symptoms of depression. MoodGYM consists of five interactive modules. Participants will be asked to complete one module each week and progress through the program sequentially.
16140923|NCT01851954|Drug|Clarithromycin|IV clarithromycin infusion
16140924|NCT01851941|Drug|mFOLFOX6 (folinic acid, 5-fluorouracil, and oxaliplatin )|Modified FOLFOX6 regimen consists of oxaliplatin 100 mg/m2 and FA 100 mg/m2 given as a 2 hour intravenous infusion, followed by 5-FU 2.4 g/m2 given as a continuous infusion over 46 hour, which is repeated every 2 weeks. Patients receive 4 cycles of neoadjuvant modified FOLFOX6 followed by curative radical surgery with D2 dissection and 4 cycles of adjuvant modified FOLFOX6.
16140925|NCT01851915|Behavioral|Cognitive Behavioral Therapy|14 sessions psychological treatment for depression
16140926|NCT01851915|Behavioral|Interpersonal Psychotherapy (IPT)|14 sessions psychological treatment for depression
16140927|NCT01851876|Device|Endometrial injury|Endometrial injury with Endometrial Suction Curette (pipelle) will be performed.
16140928|NCT01851863|Drug|Omeprazole|Prescribe Omeprazole(20mg, po, qd, 30min before breakfast).
16140929|NCT01851863|Drug|Flupentixol-Melitracen(psychological and GI) + Omeprazole|Prescribe Flupentixol and Melitracen Tablets(one tablet, po, qd, 1 hour after breakfast) and Omeprazole (20mg, po, qd, 30min before breakfast).The patients were told that: GI symptoms in FD are attributable to both psychological and GI mechanisms. Flupentixol-Melitracen relieves FD symptoms through both psychological and GI mechanisms.
16140930|NCT01851863|Drug|Flupentixol-Melitracen(psychological) + Omeprazole|Prescribe Flupentixol and Melitracen Tablets(one tablet, po, qd, 1 hour after breakfast) and Omeprazole (20mg, po, qd, 30min before breakfast). The patients were told that: GI symptoms were attributable to somatization of their psychological problems; and Flupentixol-Melitracen is an antipsychotic drug and primarily acts centrally to alleviate FD symptoms by regulating the psychological condition.
16140931|NCT01851863|Drug|Flupentixol-Melitracen(without explanation) + Omeprazole|Prescribe Flupentixol and Melitracen Tablets(one tablet, po, qd, 1 hour after breakfast) and Omeprazole (20mg, po, qd, 30min before breakfast). The patients were told only that Flupentixol-Melitrace has been proven to be effective in FD treatment and were not provided additional explanations of the relationships between their GI symptoms and their psychological condition and the reasons for the prescription of Flupentixol-Melitrace.
16140932|NCT01851850|Drug|Opicapone|25mg or 50mg once per day
16140933|NCT01851837|Other|Exercise time|Continuous training, Interval training
16140934|NCT01851824|Drug|acenocoumarol|4 mg single oral doses on Days 1 and 23
16140935|NCT01851824|Drug|vemurafenib|960 mg orally bid, 20 days (Days 4-23)
16140936|NCT01851798|Other|Home sleep test administered to all enrolled subjects|
16140982|NCT01851473|Drug|acetazolamide|15 mg orally on days 2-5
16141167|NCT01849926|Drug|Ibuprofen|
16140937|NCT01851785|Behavioral|Decision Aid (DA) Intervention|"Patients randomized to the DA Intervention will watch a Knee OA Decision Aid (DA) developed by the Foundation for Informed Medical Decision Making and then receive a brief counseling session called AskMe3. The DA is a video that provides viewers with information about OA, treatment choices such as lifestyle changes, non-drug treatments, medication, injections, complementary therapies, and surgery, as well as the pros and cons of each type of treatment. The AskMe3 is a communication, skill-building intervention, which instructs patients to ask 3 questions to the doctor: 1) What is my main problem? 2) What do I need to do? 3) Why is it important for me to do this?"
16140938|NCT01851772|Device|Treatment with Electronic Brachytherapy|
16140939|NCT01851759|Drug|cinepazide|"2 branches of Methanesulfonic acid cinepazide injection were matched into 250 ml 0.9% sodium chloride injection, iv gtt, speed is 100ml/h, once per day.
~1 branch of simulation agent of Methanesulfonic acid cinepazide injection was matched into 250 ml 0.9% sodium chloride injection, iv gtt, speed is 100ml/h, once per day."
16140940|NCT01851759|Drug|placebo|"2 branches of simulation agent of Methanesulfonic acid cinepazide injection were matched into 250 ml 0.9% sodium chloride injection, iv gtt, speed is 100ml/h, once per day.
~1 branch of simulation agent of Methanesulfonic acid cinepazide injection were matched into 250 ml 0.9% sodium chloride injection, iv gtt, speed is 100ml/h, once per day."
16140941|NCT01851733|Device|MRI-guided Laser Heat Ablation (MLA)|
16140942|NCT01851733|Drug|Doxorubicin|
16140943|NCT01851733|Other|Blood draw - dendritic cells|"The second 10 patients enrolled to Arm B:
~before MLA (up to 3 days before)
~2 weeks after MLA
~4 weeks after MLA
~every 2 weeks thereafter for up to 3 months after biopsy (provided there is no significant chemotherapy induced cytopenia)"
16140944|NCT01851733|Device|Dynamic Susceptibility Contrast Magnetic Resonance Imaging|
16140945|NCT01851720|Drug|Low dose fentanyl PCA|
16140946|NCT01851720|Drug|Standard IV fentanyl bolus|
16140947|NCT01851707|Drug|IPI-145|2 blinded capsules will be administered twice a day (morning and night) for 12 weeks.
16140948|NCT01851707|Drug|Placebo|2 blinded capsules will be administered twice a day (morning and night) for 12 weeks.
16140949|NCT01851694|Drug|GLP-1|Each subject in this arm will receive GLP-1 infusion and a placebo infusion during a GPA test.
16140950|NCT01851694|Drug|GIP|Each subject in this arm will receive GIP infusion and placebo during a GPA test.
16140951|NCT01851681|Drug|Amoxicillin|
16140952|NCT01851655|Behavioral|Plyometric Exercise|Treatment sessions include a combination of running, jumping and agility activities (plyometric exercise). Each rehabilitation session will also include an abbreviated, standardized program of lower extremity strengthening (leg press, machine squats, knee extensions; 3 sets x 10 repetitions each), flexibility (standing gastrocnemius and quadriceps stretch, hamstrings stretch in long-sitting; 2 x 30 seconds each) and proprioception (standing on foam and a tilt board; 3 x 30 seconds each).
16140953|NCT01851642|Procedure|History and physical exam.|At every study visit, participant's will be asked about their medical history and will have a physical exam.
16140954|NCT01851642|Procedure|Blood draw.|At each study visit, participants will have an intravenous catheter (IV) placed in one of their veins and blood will be drawn from the IV for study testing.
16140955|NCT01851642|Procedure|Pulmonary function testing.|At every study visit, participants will have their lung function assessed. This is done by blowing forcefully at least 3 times into a tube. Testing will be done two times; before and after the use of an Albuterol inhaler.
16140956|NCT01851642|Drug|Albuterol inhaler.|At every study visit, participating subjects will take 2 puffs of an Albuterol inhaler after the first set of PFTs, but before the second set of PFTs. There will be at least a 30 minute period after the use of the Albuterol inhaler and the second set of PFTs.
16140957|NCT01851629|Behavioral|Locomotor Training|Individuals are provided manual assistance for intense, task-specific stepping practice on a treadmill and overground.
16140958|NCT01851629|Other|Cross-Sectional Testing (No Intervention)|Individuals with and without spinal cord injury will be evaluated to develop protocols within our laboratory to assess reflexes (spinal tract integrity), walking ability, and whether mirror images during walking enhance or disrupt motor responses during walking.
16140959|NCT01851616|Dietary Supplement|25g of glucose in 200ml tap water, given orally (plus 50 mg 13C-sodium acetate)|
16140960|NCT01851616|Dietary Supplement|10g Glucose in 200ml tap water given orally (plus 50 mg 13C-sodium acetate)|
16140961|NCT01851603|Device|AVL-3288|Drug
16140962|NCT01851603|Drug|Placebo|Identical diluent to that used for AVL-3288
16140963|NCT01851590|Device|Resin Lacquer|30% Resin Lacquer is applied once daily for 9 months (Abicin®) in toenail onychomycosis.
16140964|NCT01851590|Drug|Amorolfine|5% Amorolfine Lacquer is applied once weekly for 9 months (Loceryl®) in toenail onychomycosis.
16140965|NCT01851590|Drug|Terbinafine|250 mg of Terbinafine is taken orally once daily for 3 months (Generics) in toenail onychomycosis.
16140966|NCT01851577|Behavioral|Family Foundations coparenting program|Family Foundations is a coparenting program for new mothers and fathers designed to teach them skills needed to parent together effectively and facilitate healthy child development. Family Foundations will be administered concurrently with home visiting.
16140967|NCT01851577|Behavioral|Home visiting|Home visiting is a child abuse prevention approach for new mothers designed to strengthen protective factors and mitigate risk factors in order to promote optimal child development.
16140968|NCT01851564|Device|Self-expanding mesh-metal oesophageal stent (SEMS)|A removable stent designed for the treatment of bleeding oesophageal varices.
16140969|NCT01851564|Other|Standard Therapy|Standard Medical and Endoscopic Therapy
16140970|NCT01851551|Drug|Vincristine Sulfate Liposome Injection plus rituximab|
16140971|NCT01851538|Other|Observational study; no intervention.|
16140972|NCT01851525|Device|ThermoCoolSmartTouch ablation catheter, Biosense Webster|
16140973|NCT01851512|Drug|T-R (Test-Reference drug)|
16140974|NCT01851512|Drug|R-T (Reference-Test drug)|
16140975|NCT01851499|Dietary Supplement|Ultramicronized PEA (Normast)|600 mg
16140976|NCT01851486|Drug|Clonidine|Clonidine 0.15 mg
16140977|NCT01851486|Drug|Naloxone|naloxone 0.15 mg/kg
16140978|NCT01851486|Drug|placebo|
16140979|NCT01851486|Other|saline|
16140980|NCT01851473|Drug|cocaine|25 mg IV on days 1, 5, and 10
16140981|NCT01851473|Drug|quinine|80 mg orally on days 7-10
16140983|NCT01851460|Device|Cool-tip RF Ablation System|RFA therapy will be administered according to the instructions of the RFA device manufacturer. After infiltration of the skin (for percutaneous approach) with a local anesthetic, the needle probe will be directed into the lesion. For all methods, the needle placement is confirmed to be within the lesion by ultrasound or other imaging modality as appropriate. After confirming needle placement, the lesion will be heated to a target temperature of >75 (Infinite)c for up to 15 minutes. The exposure time may be varied depending on the temperatures achieved. Depending on the size of the lesion to be ablated, multiple passes of the probe as well as multiple ablation cycles may be performed. Adequacy of ablation will be monitored by ultrasound throughout the procedure. Depending on the size of the lesions and the time required to complete the ablation, multiple lesions may be treated as staged procedures so as to improve safety.
16140984|NCT01851408|Drug|sorafenib tosylate|Given orally
16140985|NCT01851408|Drug|temsirolimus|Given IV
16140987|NCT01851343|Other|Bone Marrow Stromal Cell (BMSC) Infusion|Subjects will receive 4 weekly BMSC infusions and be monitored for AEs as well as for clinical improvement and mucosal healing.
16140988|NCT01851330|Drug|LDV/SOF|LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
16140989|NCT01851330|Drug|RBV|Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16140990|NCT01851304|Dietary Supplement|Satiety of breads|One separate breakfast session to consume each bread along with 125 mL skim milk. The session will start after an overnight fast followed by 5 separate blood draws over a 3 hour period before a provided lunch.
16140991|NCT01851304|Dietary Supplement|Satiety of puddings|One separate breakfast session will be used to evaluate satiating efficacy of puddings after an overnight fast. After pudding consumption, five separate blood draws will be taken over a 3 hour period before a provided lunch.
16140992|NCT01851278|Drug|Triamcinolone hexacetonide|High dose means 40mg or 2ml of triamcinolone hexacetonide
16140993|NCT01851278|Drug|Triamcinolone hexacetonide|Low dose means 20mg or 1 ml of triamcinolone hexacetonide
16140994|NCT01851265|Drug|Olaparib|400mg olaparib capsule formulation taken 30 minutes after allocated meal. 5-14 days between arms.
16140995|NCT01851265|Other|Dietary Fasted|Allocated breakfast prior to dosing with 400mg olaparib capsules
16140996|NCT01851265|Other|Dietary standard|Allocated breakfast prior to dosing with 400mg olaparib capsules
16140997|NCT01851265|Other|Dietary High Fat|Allocated breakfast prior to dosing with 400mg olaparib capsules
16140998|NCT01851252|Device|Methacetin (with Breath testing device)|The methacetin is enriched with carbon 13, a stable non- radioactive isotope, and has been found to be safe in hundreds of studies. The material is very similar to acetominophen. 75 milligrams (mm) of this material pre- dissolved in water are used. This material undergoes rapid metabolism by the liver.
16140999|NCT01851226|Procedure|Hands-on ERCP training.|The standard cannulation technique was used with a sphincterotome preloaded with a guidewire, positioned in the ampullary orifice, and targeting the presumed entry of common bile duct (CBD) or pancreatic duct (PD). During the whole procedure of cannulation by trainees, the senior endoscopist would actively communicate with trainees through verbal and/or hands-on assistance to help them to make the performance more correctly. If the trainees failed to enter the targeted duct within the designated length of time, the senior endoscopist would take over the duodenoscope and continue the following procedure of cannulation. The whole procedure of cannulation was recorded by video. Rectal indomethacin and/or pancreatic stent was used in high-risky patients.
16141000|NCT01851200|Drug|Brentuximab Vedotin|Intravenous Brentuximab Vedotin at the dose of 1.8 mg/Kg every 3 weeks until disease progression or onset of unacceptable toxicity
16141001|NCT01851187|Behavioral|antenatal psychological intervention|"emotion management included:
~(1) Establish relationship between the health care workers and the pregnant women, (2) Determine training objectives, (3) Guide to practice relaxation training, including imagination and abdominal breathing. (4) Make cognitive adjustment, (5) Relieve anxiety and tension by scene simulation and stimulus exposure. (6) Learn emotional self-regulation, (7) Improve self-efficacy by group interaction. (8) Teach prenatal knowledge ,(9) Guide interactive trainings between pregnant women and their couples; (10) Visit delivery rooms."
16141002|NCT01851187|Behavioral|routine prenatal care|Prenatal routine inspection included blood pressure, weight, uterine fundal height, abdominal circumference, fetal presentation, fetal position, fetal heart rate and so on.
16141003|NCT01851174|Drug|Gemcitabine|Patients will receive Gemcitabine (1,000 mg/m^2) IV over 30 minutes after nab-paclitaxel infusion
16141004|NCT01851174|Drug|nab-Paclitaxel|Patients will receive nab-Paclitaxel (125 mg/m^2) IV over 30 minutes before Gemcitabine infusion
16141005|NCT01851161|Procedure|computed tomography|Undergo conventional CT scan in both supine and prone positioning
16141006|NCT01851161|Procedure|4-dimensional computed tomography|Undergo 4D CT scan in both supine and prone positioning
16141007|NCT01851161|Radiation|radiation therapy|Undergo radiation therapy
16141008|NCT01851148|Other|osteopathic manipulative treatment|It consists of 8 sessions in 6 months. Each osteopathic session is based on a structural evaluation and an indirect technique treatment.
16141009|NCT01851148|Other|sham treatment|"Sham therapy was administered with subjects lying supine on the treatment table while the operator used light manual contact to treat the subject. The practitioner's attention was distracted by subtracting serial seven calculation in silence"
16141010|NCT01851148|Drug|triptans|administration of triptans drug treatment according to international guidelines
16141011|NCT01851135|Other|Neuropsychological examination and quality of life measures|
16141012|NCT01851122|Dietary Supplement|L-theanine capsule|L-theanine 250mg capsule
16141056|NCT01850823|Drug|Mometasone nasal spray|
16141057|NCT01850810|Other|Experimental Study Product|
16141058|NCT01850810|Other|Control Study Product|
16141059|NCT01850784|Dietary Supplement|High energy formula|The infants with CHD will be fed with high energy formula (Similac; 1kcal/ml)
16141101|NCT01850433|Behavioral|Internet based CBT for body dysmorphic disorder|
16141013|NCT01851109|Behavioral|genetic counseling|"The genetic counseling sessions are conducted by a licensed genetic counselor, certified by the American Board of Genetic Counseling and the American Board of Medical Genetics. This clinical counseling session may include, but is not limited to the following:
~A review of medical and family history information to determine which genetic test (BRCA, HNPCC, p53, etc.), if any, is appropriate;
~Discuss how the results - positive or negative - affect cancer risk
~Discuss how cancer risk might be managed (surveillance, prophylactic surgery, oral contraceptives, etc.);
~Discuss how the test is conducted and what the results might be (positive, negative, uncertain);
~Discuss the disadvantages of genetic testing (cost, insurance coverage, worry about insurance discrimination, uncertain results, etc.) and the psychological and emotional issues surrounding testing, etc."
16141014|NCT01851096|Drug|SNX-5422|Capsules dosed every other day in the morning starting at a dose of 50 mg/m2. Dose escalation based on safety. Subjects will also receive 150 mg erlotinib daily (in the afternoon).
16141015|NCT01851083|Biological|autologous bone marrow mononuclear cells|BMMNC infusion of either 6x10^6 cells/kg or 10x10^6 cells/kg weight.
16141016|NCT01851083|Other|Placebo Infusion|Placebo infusion of 0.9% Sodium Chloride
16141017|NCT01851070|Drug|Allogeneic Mesenchymal Precursor Cells|
16141018|NCT01851070|Drug|Normal Saline|
16141019|NCT01851057|Behavioral|STAR|Problem-solving and education intervention (8 total sessions)
16141020|NCT01851057|Behavioral|Education Only|Education around epilepsy (8 total sessions)
16141021|NCT01851044|Procedure|Platelet Rich Plasma|
16141022|NCT01851044|Procedure|Whole Blood Injection|
16141023|NCT01851044|Procedure|Saline Injection|
16141024|NCT01851031|Procedure|the minor approach|Thirty-six patients (the minor approach group) were treated with minor parotid anterior approach
16141025|NCT01851018|Radiation|Hypofraction|Patient reported toxicities related to Hypofraction radiation treatment (3 Gy daily, 5 fractions per week) up to a total of 36 Gy to the prostate (+/- seminal vesicles) plus brachytherapy boost (15 Gy in a single fraction) with 4 months neo-adjuvant firmagon (240 mg given as two subcutaneous injections of 120 mg at a concentration of 40 mg/mL as a starting dose with a maintenance dose of 80 mg given as one subcutaneous injection at a concentration of 20 mg/mL administered every 28 days).
16141026|NCT01851018|Radiation|Standard|Patient reported toxicities related to the Standard radiation treatment (2 Gy daily, 5 fractions per week) up to a total of 44 Gy to the prostate (+/- seminal vesicles) plus brachytherapy boost (15 Gy in a single fraction) with 4 months neo-adjuvant LHRH agonists
16141027|NCT01851005|Drug|Dexmedetomidine|Infusion of dexmedetomidine (0.4 ug/kg/hr)
16141028|NCT01851005|Drug|Sevoflurane|Control Vol% to maintain BIS 40~45
16141029|NCT01851005|Drug|Propofol and Remifentanil|Control effect site concentration for maintain BIS 40~45 and changes of vital signs within 20%.
16141030|NCT01851005|Drug|Normal saline|Use as placebo
16141031|NCT01851005|Drug|Rocuronium|0.8 mg/kg for induction
16141032|NCT01850992|Device|Active CPAP|Effective CPAP will be administered
16141033|NCT01850992|Device|Sham CPAP|This is placebo CPAP
16141034|NCT01850979|Drug|Tacrolimus|tacrolimus 0,03% eyedrops (olive oil vehicle) every 12 hours for 3 months placebo : olive oil eyedrops every 12 hours for 3 months
16141035|NCT01850979|Drug|Olive Oil|All patients in this groups receive eye drops containing olive oil (vehicle of tacrolimus eye drops) twice a day (every 12 hours) for 90 days.
16141036|NCT01850966|Drug|Iguratimod|The usual adult dosage for oral use of 25 mg tablet of iguratimod once daily for 4 weeks or more, after which the dosage should be increased to one 25 mg tablet taken twice daily.
16141037|NCT01850953|Drug|Varenicline|This is an approved smoking cessation medication.
16141038|NCT01850953|Drug|Placebo|
16141039|NCT01850940|Drug|Tolvaptan|Tolvaptan (OPC-41061) is a benzazepine derivative synthesized by Otsuka Pharmaceutical Company, Ltd. Tolvaptan was approved for the treatment of specific forms of hyponatremia by the United States (US) Food and Drug Administration (FDA) in May 2009, the European Medicines Agency on Aug 2009, Japan (Oct 2010), China (Sep 2011) and Korea (Sep 2011). Tolvaptan was approved for the adjunct treatment of volume overload in heart failure by the Japanese Ministry of Health, Labour, and Welfare (MHLW) in Oct 2010. It is also being developed for the treatment of autosomal dominant polycystic kidney disease (ADPKD), and for the treatment of hepatic edema.
16141040|NCT01850940|Other|conventional thearpy|conventional therapy with salt limitation ,et al
16141041|NCT01850927|Procedure|Remote ischaemic preconditioning|
16141042|NCT01850927|Procedure|Control|
16141043|NCT01850901|Procedure|Renal sympathetic denervation|
16141044|NCT01850888|Drug|131 I-Metaiodobenzylguanidine (131I-MIBG)|Minimum dose of 10 mCi/kg and up to 18 mCi/kg maximum will be diluted in 25 ml of normal saline, and will be infused intravenously over 90-120 minutes.
16141045|NCT01850888|Drug|Potassium iodide solution|For the therapeutic MIBG administration, potassium iodide solution will be administered in a loading dose of 6mg/kg orally at least 8 hours prior to the MIBG injection, and then will be given at 1mg/kg/dose every 4 hours on days 0-6, then 1 mg/kg/day through day 45 post injection. The minimum dose of potassium iodide to be given is one drop, which equals 50 mg.
16141046|NCT01850888|Drug|G-CSF|It is recommended that patients with ANC less than 750 after MIBG infusion begin G-CSF 5 mcg/kg/day subcutaneously (or receive equivalent single dose of Neulasta every 14 days while neutropenic) until neutrophil recovery (generally >5000).
16141047|NCT01850888|Procedure|hematopoietic stem cell infusion|The majority of patients on this protocol will have autologous PBSCs available. Allogeneic stem cells may be utilized in patients who has received a prior allogeneic transplant. The minimum quantity for peripheral blood stem cells is 1.5 x 106 CD34+ cells/kg (optimum > 2 x 106 CD34+ cells/kg). The minimum dose for bone marrow is 1.0 x 108 mononuclear cells/kg (optimum >2.0 x 108 mononuclear cells/kg). Infusion will be performed according to institutional guidelines.
16141048|NCT01850875|Behavioral|Eye-Movement-Desensitization-Reprocessing|
16141049|NCT01850862|Other|Collective group exercise program in patients with KOA|
16141050|NCT01850862|Other|Orientation (without exercise)|Orientation about osteoarthritis disease but without any exercise program
16141051|NCT01850849|Drug|LEO 39652 cream|
16141052|NCT01850849|Drug|cream vehicle|
16141053|NCT01850836|Procedure|repetitive transcranial magnetic stimulation|
16141054|NCT01850823|Drug|placebo|
16141055|NCT01850823|Drug|Mometasone Nasal Spray|
16141061|NCT01850771|Procedure|Regenexx PL-Disc|Injection into the epidural space under image guidance of autologous, concentrated peripheral blood based platelet mix combined with a nanogram dose of corticosteroid.
16141062|NCT01850771|Procedure|Steroid Epidural|Injection into the epidural space under image guidance of 3 mg of betamethasone.
16141063|NCT01850758|Procedure|Regenexx SD|stem cell treatment
16141064|NCT01850758|Other|Exercise Therapy|exercise therapy control
16141065|NCT01850745|Other|Multidisciplinary support program|Multidisciplinary support program that included counselling about relevance of adherence by hepatologist, nurse and pharmacist. Psychologist and psychiatrist support if needed.
16141066|NCT01850732|Other|Ultrasound of aorta|
16141067|NCT01850719|Procedure|Arthroscopic Partial Meniscectomy|Arthroscopic partial APM is performed within 4 weeks in day-care. No standard physical therapy is prescribed after surgery, as advised by the Dutch Orthopaedic Association Guidelines.
16141068|NCT01850719|Other|Physical Therapy|"Conservative treatment consist of 16 sessions PT and a home exercise program. These programs are developed for our population, 45-70 years, with a focus on closed-chain strength exercises and cardiovascular exercises.
~In case conservative treatment has failed, patients can cross-over and delayed APM is then performed. This can be done, from completion of the PT program, during the entire study."
16141069|NCT01850680|Drug|sarilumab SAR153191 (REGN88)|Pharmaceutical form:solution Route of administration: subcutaneous
16141070|NCT01850680|Drug|placebo|Pharmaceutical form:solution Route of administration: subcutaneous
16141071|NCT01850680|Drug|methotrexate|Pharmaceutical form:capsule Route of administration: oral
16141072|NCT01850680|Drug|folic acid|Pharmaceutical form:tablet Route of administration: oral
16141073|NCT01850667|Radiation|Stereotactic body radiotherapy|"Total stereotactic Body radiotherapy (SBRT) doses will be 60 Gy in 3 fractionations. Patients receive 3 fractionations separated by >48 hours.
~At least 700 ml of normal liver (entire liver minus cumulative GTV) should not receive a total dose of > 17 Gy in three fractions. If volume of normal liver does not exceed 700 ml, at least 70% of normal liver should not receive a total dose of > 17 Gy. In patients without gastroduodenal ulcer on Esophagogastroduodenoscopy (EGD) before SBRT, D2ml of gastrointestinal tract should not exceed 35 Gy. In patients with gastroduodenal ulcer on EGD before SBRT, D2ml of gastrointestinal tract should exceed 28 Gy. (D2ml: minimum dose to 2 ml of gastrointestinal tract)"
16141074|NCT01850654|Genetic|LS tumor screening|All participants with CRC or EC will have LS tumor screening (MSI, IHC, methylation if applicable).
16141075|NCT01850654|Genetic|Genetic testing|"Next-generation sequencing panel of several genes that increase the risk for hereditary cancers including the LS genes (MLH1, MSH2, MSH6, PMS2, EPCAM), polyposis genes (MUTYH, APC), and others.
~The following study participants will have free genetic testing:
~CRC and EC study participants with unmethylated MSI-high (MSI-H) tumors
~CRC and EC study participants with microsatellite stable (MSS) or MSI-low (MSI-L) tumors who have abnormal IHC results and they do not have methylation of the MLH1 promoter
~CRC study participants diagnosed with CRC <50 years, regardless of tumor studies or family history
~CRC study participants diagnosed with CRC ≥ 50 years with a FDR with CRC or EC OR synchronous or metachronous CRC or EC throughout their life, regardless of tumor studies.
~At-risk relatives of the individuals found to have LS are eligible for free single site genetic testing."
16141076|NCT01850654|Behavioral|Genetic Counseling|"The participants found to have LS or another type of hereditary cancer will have free genetic counseling.
~At-risk relatives of the individuals found to have LS are eligible for free genetic counseling."
16141077|NCT01850654|Other|Biorepository|The biorepository is an optional part of the OCCPI. CRC and EC participants will contribute leftover tumor and blood samples, as well as a saliva sample. FDR of the CRC participants will contribute a saliva sample. The at-risk relatives of those found to have LS will contribute blood and saliva samples.
16141078|NCT01850654|Behavioral|Questionnaire|
16141079|NCT01850641|Drug|PA21|
16141080|NCT01850628|Drug|Paclitaxel|
16141081|NCT01850628|Biological|trastuzumab|
16141082|NCT01850628|Biological|pertuzumab|
16141083|NCT01850615|Drug|Faster-acting insulin aspart|Administrated subcutaneously (s.c., under the skin) at each main meal.
16141084|NCT01850615|Drug|basal insulin|Administrated subcutaneously (s.c., under the skin) once daily.
16141085|NCT01850602|Drug|PA21|
16141086|NCT01850602|Drug|Sevelamer hydrochloride|
16141087|NCT01850589|Other|Aggressive Therapy|"Pharmacotherapy adjuncts offered at no cost are as follows:
~Chantix (varenicline) GlaxoSmithKline,
~Zyban (bupropion) Pfizer,and Nicoderm/Nicorette (nicotine nasal spray, inhaler, transdermal patches and gum) GlaxoSmithKline."
16141088|NCT01850576|Behavioral|Risk Reduction Intervention|STEP is based on social learning theory and provides age-appropriate and culturally acceptable HIV prevention information in a format that encourages information growth and skills enhancement. The program is delivered by 'Instructors,' undergraduate college students aged 18-24, one hour per week for 10 weeks.
16141089|NCT01850563|Device|Hyperbaric oxygen given at 2.4 ATA for 30 minutes immediately prior to SRS - HBOT for 30 minutes - SRS without prior HBO|
16141090|NCT01850550|Behavioral|Weight loss Groups|The intervention will consist of 12 weekly one-hour weight loss sessions led by successful volunteer peers. Participants are provided with a modified version of the Diabetes Prevention Program manual and are mentored by peer leaders at weight loss sessions.
16141091|NCT01850537|Device|treatment of degenerative disc disease using the PROW LIF|TLIF procedure for the treatment of degenerative disc disease using the PROW LIF procedure (system)
16141092|NCT01850524|Drug|Ixazomib|IXAZOMIB capsules.
16141093|NCT01850524|Drug|Placebo|IXAZOMIB matching-placebo capsules.
16141094|NCT01850524|Drug|Dexamethasone|Dexamethasone tablets.
16141095|NCT01850524|Drug|Lenalidomide|Lenalidomide capsules.
16141096|NCT01850511|Procedure|Vibrissae trimming|Patients will have oxymetazoline administered prior to assessment of outcome measures to ensure minimal impact of erectile mucosal tissue on measurement.
16141097|NCT01850511|Drug|Application of oxymetazoline|Afrin will be administered to minimize the impact of erectile mucosal tissue on obstruction.
16141098|NCT01850485|Device|microcirculation by SDF and NIRS, in 33 and 36 degrees|at baseline, after 12 and 24 hours in both arms
16141099|NCT01850446|Drug|Ergoferon|Safety and Efficacy
16141100|NCT01850446|Drug|Oseltamivir|Safety and Efficacy
16141102|NCT01850420|Drug|IMC-1|
16141104|NCT01850394|Drug|Tranexamic Acid|Inject tranexamic acid solution intra-articularly after fascia closure
16141105|NCT01850394|Drug|Physiologic saline|Use physiologic saline for mixing with tranexamic acid or use alone in placebo group
16141106|NCT01850381|Drug|GM608|For GM608: 320 mg/dose reconstituted with 6.4 mL bacteriostatic saline. Administer 6.4 mL GM608 dosing solution by intravenous (IV) bolus over 1 min, on Monday, Wednesday, Friday for two consecutive weeks.
16141107|NCT01850381|Drug|Placebo Comparator|For Placebo: Administer 6.4 mL Bacteriostatic saline by intravenous (IV) bolus over 1 min, on Monday, Wednesday, Friday for two consecutive weeks.
16141108|NCT01850368|Radiation|Stereotactic ablative radiotherapy|"The HCC patients with major portal vein tumor thrombosis (tumor thrombosis in the main portal vein or 1st branch of portal vein) will be included in this study. Total stereotactic ablative radiotherapy (SABR) doses will be 40 Gy in 4 fractionations. Patients receive 4 fractionations separated by >48 hours.
~At least 700 ml of normal liver (entire liver minus cumulative GTV) should not receive a total dose of > 19.2 Gy in three fractions. If volume of normal liver does not exceed 700 ml, at least 70% of normal liver should not receive a total dose of > 19.2 Gy. Dose of spinal cord do not exceed 26 Gy. Dose of esophagus, stomach and intestine do not exceed 35 Gy."
16141109|NCT01850355|Drug|Buspirone|Children with autism spectrum disorders will receive buspirone treatment for eight weeks. Buspirone will be titrated to the maximum daily dose during the first four weeks of the trial (dose titration phase). Week 4 onwards, subjects will be maintained on maximum achieved dose until the end of the trial (dose maintenance pahe). During the titration phase, total dose will be increased by 10mg at each visit and by 5mg on the 4th day after each visit.
16141110|NCT01850342|Procedure|Periurethral injection of fat micrograft enriched with ADRC|Subjects will undergo liposuction under local anesthesia. One part of lipoaspirate will be processed to isolate and concentrate ADRCs. Another part of lipoaspirate will be washed and homogenized to prepare fat tissue micrograft. After that fat tissue micrograft will be mixed with ADRC. Autologous fat micrograft enriched with ADRC will be injected at the bulbomembranous region of urethra circle-wise under endoscopic vision.
16141111|NCT01850329|Other|computed-assisted information program|
16141112|NCT01850316|Radiation|Stereotactic Ablative Radiotherapy|Preferred target coverage of 40 Gy: coverage and total dose determined by irradiated liver volume NTCP (normal tissue complication probability) nomogram and OAR dose limits
16141113|NCT01850303|Drug|Pemetrexed|
16141114|NCT01850303|Drug|Gemcitabine|
16141115|NCT01850303|Drug|Induction chemotherapy|4 cycles of carboplatin-paclitaxel
16141116|NCT01850277|Drug|Amiodarone|The pharmacological treatment in the rhythm control strategy consist of amiodarone given orally including the loading dose up to 600mg daily - for the first 4 weeks. Then, a maintenance dose of 200mg/daily is prescribed. The use of other anti-arrhythmic agents is possible unless they are contraindicated. The introduction of amiodarone must not be performed unless the patient is treated effectively with oral anticoagulants for 3 weeks at least. Discontinuation of amiodarone results neither in withdrawal from the study nor in change of the treatment arm.
16141117|NCT01850277|Procedure|External electrical cardioversion (EEC)|"The first EEC is performed after the loading dose of amiodarone has been administered. A maximal number of shocks during one cardioversion is 3. The amount of the energy delivered during shocks is left at discretion of a physician performing the EEC. The EEC must be performed in accordance with the present guidelines on EEC and post-procedural care and the state of art.
~If atrial fibrillation reoccur, the patient should undergo a next EEC as soon as possible but preserving the safety time margins (i.e. effective anticoagulation period). The maximal no. of EEC procedures is 3. If sinus rhythm resumption or its maintenance is impossible or AF reoccur after the 3rd EEC, a strategy of rhythm control is discontinued and a rate control strategy is implemented."
16141118|NCT01850277|Drug|Pharmacotherapy to slow and control ventricular rate|The pharmacotherapy should be consistent with current guidelines. It should include negative chronotropic and negative dromotropic agents such as beta-blockers, digitalis and amiodarone (the use of other, less popular agents, is also possible). The choice of the agents as well as their dosages are left at discretion of the treating physician. The goal of the therapy is to obtain BiVp% >95%
16141119|NCT01850277|Procedure|Atrioventricular junction ablation (AVJA)|The procedure of atrioventricular junction ablation is dedicated to the patients in the rate control group in who the rate control is unsatisfactory. An AVJA procedure is not obligatory. The decision to perform an AVJA should be discussed with the patient and should be made collectively by the therapeutic team.
16141120|NCT01850264|Device|Application of quadripolar / bipolar LV electrodes|
16141121|NCT01850251|Dietary Supplement|Supplement with HMB and vitamin D|High protein, high calorie nutritional supplement enriched with hydroxymethylbutyrate and vitamin D.
16141122|NCT01850251|Dietary Supplement|Standard nutritional supplement|High protein, high calorie nutritional supplement.
16141123|NCT01850238|Biological|AADvac1|AADvac1 is intended as an active vaccination for disease-modifying treatment of Alzheimer's disease.
16141124|NCT01850238|Other|Placebo|The placebo contains the same buffer and adjuvant as AADvac1, but lacks the API.
16141125|NCT01850225|Device|Auditory brainstem implant|
16141126|NCT01850199|Other|Smart telemedicine remote monitoring for gestational diabetes|Intervention consists of a telemedicine platform which includes artificial intelligence tools to analyse glucose values and guarantee an optimal glucose control from the diagnosis of gestational diabetes to delivery.
16141127|NCT01850199|Other|Usual management|Usual care will be provided, including face-to-face visits
16141128|NCT01850186|Device|Dual yellow Laser|Patients will receive treatment by stabilized kilnman trio for four weeks (one application per day). Patient will receive 4 treatments by Dual yellow Laser on the hemi-face (side determinated by randomisation, split body study) at weeks 4, 6, 9 and 12.
16141129|NCT01850186|Drug|Stabilized kilnman trio|The stabilized kilnman trio will be prescribed for one month at inclusion (all over the face, one application per day), and on the half of the face not treated by laser at weeks 4, 8 and 12 (one application per day).
16141130|NCT01850173|Device|A vertical vibration platform Fitybe|They performed 6 series, and each series consisted of four 30-second repetitions with a frequency of 35 Hz and 2 millimeters of amplitude, with 60 seconds of rest between each series.
16141168|NCT01849926|Drug|Mecillinam|
16141415|NCT01847976|Drug|Doxycycline|Participants will be asked to take 100 mg of Doxycycline by mouth twice a day for 12 weeks.
16142025|NCT01843413|Procedure|quality-of-life assessment|Ancillary studies
16141131|NCT01850160|Drug|GROUP A: Valsartan plus Chlorthalidone|Combination therapy of Valsartan plus Chlorthalidone: Valsartan 80 mg / Chlorthalidone 12,5 mg. Once daily during 12 weeks. If the goals of blood Pressure are uncontrolled at week 6, the dose will be increase to Valsartan 160 mg / Chlorthalidone 25 mg once daily.
16141132|NCT01850160|Drug|GROUP B: Valsartan|GROUP B: Treatment monotherapy: Valsartan 80 mg once daily during 12 weeks. If the goals of blood Pressure are uncontrolled at week 6, the dose will be increase to Valsartan 160 mg once daily.
16141133|NCT01850160|Drug|GROUP C: Chlorthalidone|GROUP C: Treatment monotherapy: Chlorthalidone 12,5 mg once daily during 12 weeks. If the goals of blood pressure are uncontrolled at week 6, the dose will be increase to Chlorthalidone 25 mg once daily.
16141134|NCT01850147|Drug|Sunitinib, chemotherapy|sunitinib, 12.5mg/day, for 7 days before each cycle of chemotherapy; chemotherapy, single agent including docetaxel, albumin-bound paclitaxel, vinorelbine, gemcitabine, pemetrexed, or paclitaxel, as determined by the investigator
16141135|NCT01850134|Other|Experimental Study Product|
16141136|NCT01850134|Other|Control Study Product|
16141137|NCT01850121|Drug|Infliximab|5 mg/kg every 6 weeks during the first year and 3 mg/kg every 8 weeks during the second year. Concomitant treatment with methotrexate 7.5 mg/week.
16141138|NCT01850108|Drug|Thymoglobulin|"Day 9 - 0.5 mg/kg IV before BMT
~Days 8 & 7 - 2mg/kg IV before BMT"
16141139|NCT01850108|Drug|Fludarabine|On Days -6 to -2 before BMT, 30 mg/m2/day IV
16141140|NCT01850108|Drug|Cyclophosphamide (CTX)|Days 6 & 5 before BMT, 14.5 mg/kg IV; 50 mg/kg each day on 3rd & 4th day after BMT
16141141|NCT01850108|Drug|Mesna|Days 3 & 4 after BMT: 40 mg/kg IV
16141142|NCT01850108|Drug|Sirolimus|Adjusted to maintain a serum trough level of 3-12 ng/mL, taken orally beginning on 5 days after BMT and taken to 1 year after BMT.
16141143|NCT01850108|Drug|Mycophenolate mofetil (MMF)|15 mg/kg orally with maximum dose 3 mg/day beginning 5 days after BMT and taken to day 35 after BMT
16141144|NCT01850108|Procedure|Bone marrow transplantation|Day 0 - Transplantation of hematopoietic cells derived from bone marrow of a donor to a recipient as treatment for hematologic disorders
16141145|NCT01850108|Radiation|Total body irradiation|200 cGy on the day before BMT. Radiation delivered to the entire body of the recipient to eradicate bone marrow cells in the recipient to prepare the recipient to receive the transplanted
16141146|NCT01850095|Drug|treatment azelaic acid (azelan)|treatment for 6 months
16141147|NCT01850095|Drug|dorspirenone/ethynil estradiol|
16141148|NCT01850082|Procedure|Vein Harvesting Procedures|"Open Vein Harvesting is the traditional method of saphenectomy for CABG. It is performed under direct vision using a single long incision or, more commonly, multiple smaller incisions (referred to as bridging technique) along the course of the vein. This approach minimizes manipulation and direct trauma to the conduit but is associated with potential for discomfort and leg wound healing complications. Endoscopic Vein Harvesting is a minimally invasive procedure that was developed to eliminate the need for long incisions associated with OVH. EVH reduces the risk of wound infections and other leg wound complications but may be more traumatic to the conduit than OVH."
16141149|NCT01850056|Device|drug eluting balloon catheter (trade name: Orchid)|
16141150|NCT01850056|Device|common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral)|
16141151|NCT01850030|Drug|Dydrogesterone 30 mg|Oral Dydrogesterone 10 mg tablets tid
16141152|NCT01850030|Drug|Micronized Progesterone 600 mg|Intravaginal micronized progesterone 200 mg capsules tid
16141153|NCT01850030|Drug|Placebo progesterone|Placebo intravaginal micronized progesterone 200 mg capsules tid
16141154|NCT01850030|Drug|Placebo dydrogesterone|placebo oral dydrogesterone 10 mg tablets tid
16141155|NCT01850017|Drug|Dexmedetomidine|In the intervention arm dexmedetomidine at a dose of 1 mcg/kg over 20 mins followed by an infusion of 0.5 mcg/kg/h for the duration of the surgery.
16141156|NCT01850004|Drug|Dasatinib|
16141157|NCT01849991|Biological|Lactobacillus reuteri|"Lactobacillus reuteri oil drops are a natural product containing Lactobacillus reuteri (LR), which has traditionally been used for the establishment of a well-functioning gastrointestinal (GI) microbiota and prevention and treatment of mild diarrhea associated with GI-tract infections, travel or antibiotic treatment.
~The drug is a clear liquid when suspended in sunflower oil. The drug will be administered orally, 0.2cc once daily."
16141158|NCT01849991|Biological|Placebo|Placebo is sunflower oil (vehicle for LR). The placebo will be administered the same way as drug listed above.
16141159|NCT01849978|Behavioral|Newsletter about physical activity and breast cancer survivors|Both groups will receive a newsletter that covers: 1) the recommendation to pursue at least 150 mins/week of moderate to strenuous intensity PA, 2) the benefits of PA specific to breast cancer survivors (e.g., reducing in death and breast cancer recurrence), and 3) their total minutes of moderate to strenuous intensity PA and how this compares to the recommendation.
16141160|NCT01849978|Behavioral|Changing your habits brochure|"Both groups will receive the brochure titled Changing Your Habits: Steps to Better Health, developed by the NIH, that describes, based a person's stage of change, the benefits of PA, how to overcome common barriers to PA, and if ready, how to plan for PA."
16141161|NCT01849978|Behavioral|Tips for making exercise enjoyable and personally-valued|Participants will get a list of potentially enjoyable activities and a space to list other activities after they consider aspects that can make events fun/interesting.13 Aspects to consider include: location (indoors vs. outdoors, the latter which may appeal to some), hobbies that can involve PA (e.g., sports, dancing), whether the activity is made more enjoyable by having it performed by oneself or with others (e.g., team activities vs. individual activities); what valued outcomes may be achieved (e.g., sense of competence, pride, better health, body image), accompanying activities that are pleasant (e.g., listening to music), etc.
16141162|NCT01849978|Behavioral|Testimonials from breast cancer survivors|Participants will get two to three testimonials of actual breast cancer survivors. These testimonials will include story-like details of what these survivors find enjoyable about exercising and what they have done to make exercise enjoyable.
16141163|NCT01849965|Drug|DSC127|DSC127 0.03%, daily topical application to diabetic foot ulcer for a period of up to 28 days or until ulcer closure, whichever occurs sooner.
16141164|NCT01849965|Drug|placebo vehicle gel|
16141165|NCT01849965|Drug|Standard of Care gel, Aquasite|
16141166|NCT01849939|Drug|Fludarabin (post-allograft immunosuppressive therapy modulation and DLI Mononuclear cells from allogenic blood)|
16141169|NCT01849913|Other|Laser|The laser will be used 830 nm, 30 milliwatts twice a week: the initial dosage will be 5.9 J per point. The irradiation will be performed bilaterally on the belly of the trapezius muscle as well as 2 cm to the right and left and 2 and 4 cm below the belly of the muscle.
16141170|NCT01849913|Other|Placebo|"To provide the blinding: the laser equipment has two identical application points furnished by the manufacturer - one active and the other a placebo (does not emit energy)."
16141171|NCT01849900|Other|Knowing your body|"Women will receive the Knowing your body kit. The kit contains: 6 ovulation test strips, a 12 month menstrual log sheet/calendar, and a thermometer to help women determine their body temperature; and educational materials that contain information on female body parts involved in pregnancy, hormones and the menstrual cycle, how birth control works, body temperature changes, characteristics of cervical fluid, and adapting to pregnancy during the first trimester. Participants will receive a total of 10 visits. During the first visit, the nursing student/community health workers team will review the intervention kit and continue to discuss topics related to women's health during subsequent visits."
16141172|NCT01849900|Behavioral|Healthy Lifestyle|Women will receive educational materials on healthy lifestyle such as maintaining good nutrition and the importance of folic acid for women of childbearing age during the first visit. Participants will receive a total of 10 visits. The nursing student/community health workers team will continue to discuss topics related to promoting healthy lifestyle during subsequent visits.
16141173|NCT01849887|Biological|bone marrow-derived mesenchymal stem cells|bone marrow-derived mesenchymal stem cells
16141174|NCT01849887|Drug|Placebo|Placebo
16141175|NCT01849874|Drug|MEK162, MEK inhibitor; oral|multiple dose, single schedule
16141176|NCT01849874|Drug|Physician's choice chemotherapy|"Patients will receive one of the following chemotherapies as determined by the physician:
~Liposomal doxorubicin, anthracycline antibiotic; intravenous (multiple dose, single schedule)
~Paclitaxel, mitotic inhibitor; intravenous (multiple dose, single schedule)
~Topotecan, topoisomerase 1 inhibitor; intravenous (multiple dose, single schedule)"
16141177|NCT01849861|Drug|Methimazole|"Patients with serum TSH initially on the 1st. Quartile (TSH: 0.4 to 1.0 mIU / ml) will receive treatment with Methimazole (initial dose of 5mg/day) with the goal of raising the TSH values to range between 2.0 and 4.0 mIU / ml (the half upper range of normal).
~After six months with TSH in the target range (2.0 and 4.0 mIU / ml), these patients will be subjected to the same examination protocol performed at baseline and assessed to the effects of treatment on outcome variables.
~Variables considered in this study:
~TSH and FT4
~Questionnaire of Quality of life for older adults (WHOQOL-OLD)
~Mini-Mental State Examination
~Geriatric Depression Scale
~Cardiopulmonary exercise testing - cardiopulmonary capacity"
16141178|NCT01849848|Drug|SyB L-0501|The administration of SyB L-0501 at 90 mg/m^2/day by 60-minute intravenous infusion for 2 consecutive days followed by 26 days of monitoring. This is considered to be one cycle and may be repeated up to 6 times. Dose reduction or discontinuation is permitted from the second cycle as necessary according to adverse events and the results of monitoring during the previous cycle.
16141179|NCT01849835|Procedure|trans-rectal to perform the prostate biopsy|the puncture points are at the rectal
16141180|NCT01849835|Procedure|trans-perineal to perform the prostate biopsy|the puncture points are at the perineal
16141181|NCT01849822|Device|Neural Prosthetic System|The Neural Prosthetic System is primarily composed of two NeuroPort Arrays. Each array is comprised of 100 microelectrodes (1.5 mm in length) uniformly organized on a 4 mm x 4 mm silicon base that is 0.25 mm thick. Each microelectrode is insulated with Parylene-C polymer and is electrically isolated from neighboring electrodes by non-conducting glass. Each microelectrode has a platinum tip that is 100-200 microns in length and offers impedance values from 100-800 kilo-ohms. Of the 100 electrodes, 96 are wire bonded using 25 micron gold alloy insulated wires collectively sealed with a silicone elastomer. The wire bundle is potted to a printed circuit board with epoxy, the printed circuit board is inserted into the Patient Pedestal (percutaneous connector), and then the Patient Pedestal is filled with silicone elastomer. Two fine platinum reference wires are also attached to the Patient Pedestal. The Patient Pedestal is 19 mm wide at the skin interface.
16141182|NCT01849809|Procedure|Gamma Ventral Capsulotomy|
16141183|NCT01849796|Device|tDCS|TDCS/sham will be delivered using the battery-operated device Phoresor II Auto with two saline-soaked sponge electrodes. To deliver excitatory (anodal) tDCS over the motor cortex, the main electrode will be placed over the motor cortex on the hemisphere contralateral to the major source of pain. The second electrode will be placed on the skin overlying the supraorbital region ipsilateral to the affected area. To deliver inhibitory (cathodal) tDCS, the main electrode will be placed over the somatosensory cortex on the hemisphere contralateral to the major source of pain. The second electrode will be placed on the skin overlying the supraorbital region ipsilateral to the affected area. The current will be delivered at the intensity of 2mA for 20 minutes. To deliver sham, the current will be delivered for 30 sec only to elicit tingling skin sensation but no cortical excitability changes.
16141184|NCT01849783|Drug|dexamethasone|Given PO
16141185|NCT01849783|Drug|cisplatin|Given IV
16141186|NCT01849783|Drug|doxorubicin|Given IV
16141187|NCT01849783|Drug|cyclophosphamide|Given IV or PO
16141188|NCT01849783|Drug|etoposide|Given IV
16141189|NCT01849783|Drug|bortezomib|Given IV
16141190|NCT01849783|Drug|thalidomide|Given PO
16141191|NCT01849783|Drug|melphalan|Given IV
16141192|NCT01849783|Procedure|autologous stem cell transplant|
16141193|NCT01849770|Drug|Mexiletine|
16141194|NCT01849770|Drug|Placebo|
16141195|NCT01849757|Other|prime crystalloid|used for priming the CPB circuit
16141196|NCT01849757|Other|Human Albumin|Used as a constituent for priming the CPB circuit
16141197|NCT01849757|Other|Voluven|Used as a constituent for priming the CPB circuit
16141198|NCT01849744|Drug|VS-4718|
16141233|NCT01849419|Drug|Within-subjects (oxytocin)|This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received oxytocin (20 IU) on one session, MDMA on two sessions (see first Intervention), and placebo on one session (see third Intervention).
16141234|NCT01849419|Drug|Within-subjects (placebo)|This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received placebo on one session, MDMA on two sessions (see first Intervention), and oxytocin (20 IU) on one session (see second Intervention).
16142026|NCT01843413|Procedure|cognitive assessment|Ancillary studies
16141199|NCT01849731|Other|Face-to-face|is carried out by the GPs during the clinic visit and consists of seven visits, one every three months. Each session consists of completing a diabetes care record sheet (DCRS) together with the patient. The DCRS consists of two parts: Five questions on self-care activities in the last three months and a graph with previously measured HbA1c levels. This information is completed at each session, resulting in a graph showing the evolution of glycaemic control related to self-care activities. The DCRS is explained patients, emphasising the relationship between self-care and glycemic control. At the end of the session, patients are given a copy of the DCRS and suggested to show it and discuss it with their relatives.
16141200|NCT01849731|Other|Face-to-face intervention plus telephone reinforcement|In this group patients receive the above described intervention A plus a telephone reinforcement It consists on five telephone calls lasting about 10 minutes each, to provide advice on carrying out physical exercise and eating a balanced diet and to encourage the use of health services related to diabetes control. Any problems or doubts that patients have stemming from any aspect of diabetes care are also discussed. Telephone reinforcement is carried out by a professional who has previously been trained in promoting T2DM self-management and in motivational interviewing techniques.
16141201|NCT01849705|Other|No intervention|
16141202|NCT01849692|Drug|ESBA1008 solution|Intravitreal injection or infusion
16141203|NCT01849692|Drug|Ranibizumab|Intravitreal injection
16141204|NCT01849679|Other|Evaluation of Swallowing|Evaluating for pharyngeal delay, pharyngeal stasis, and penetration/aspiration
16141205|NCT01849666|Drug|phenprocoumon|6 mg oral single dose
16141206|NCT01849666|Drug|vemurafenib|960 mg bid orally
16141207|NCT01849640|Drug|DHA-piperaquine and Primaquine|Subject will be enrolled in open label fashion to a 3-day treatment course of DHA-piperaquine (DP) by directly observed therapy (DOT, all patients will receive a total of 9 tablets containing 40mg DHA and 320mg of piperaquine in divided doses at 0, 24 and 48 hours (3 tablets once per day) for the 3 day course. At completion of DP treatment volunteers will be randomized in an open label fashion to receive a single 45 mg dose of primaquine or no therapy.
16141208|NCT01849627|Behavioral|Low-ED|This condition will be instructed to make food consumption decisions based solely upon the ED of a food. The goal of the ED condition will be to consume at least 10 foods ≤ 1.0 kcal/g (i.e., fruits and vegetables, broth based soups, non-fat yogurts, some legumes, egg substitutes, some white fish, etc.) and no more than 2 foods ≥ 3.0 kcal/g (i.e., crackers, chips, cookies, hard cheeses, hot dogs, salad dressings, etc.) per day.
16141209|NCT01849627|Behavioral|Energy Balance|Energy Balance will receive an individualized daily energy goal which will be their measured resting metabolic rate multiplied by a physical activity level (PAL) of 1.12 (men) or 1.14 (women) (low active).
16141210|NCT01849614|Other|Cardiac SPECT perfusion scan|A SPECT cardiac perfusion scan provides a three-dimensional map of blood flow to the heart tissue. The scan will be taken at rest only.
16141211|NCT01849601|Device|percutaneous transluminal angioplasty balloon catheter|
16141212|NCT01849588|Drug|Sorafenib|
16141213|NCT01849575|Behavioral|Intervention|"Information about carotid ultrasound results to the participant and his/her primary care physician in the form of atherosclerosis highlighted graphically in color against normal vascular age patterns and as plaque formation. General information about atherosclerosis as a dynamic modifiable process and recommendation to follow clinical guidelines for risk factor control. After 2-4 weeks a follow-up call by a research nurse, to give additional information and reassurance, if needed. Identical information to the study participant is sent by post after 6 months.
~CVD risk factors are managed according to clinical guidelines within primary health care during the entire study period."
16141214|NCT01849562|Drug|Sovaprevir|NS3/4A protease inhibitor
16141215|NCT01849562|Drug|ACH-3102|NS5A inhibitor
16141216|NCT01849562|Drug|RBV|
16141217|NCT01849562|Drug|Placebo|
16141218|NCT01849549|Behavioral|Neuropsychological testing|Experimental test about cognitive deficit of interest and standard neuropsychological tests.
16141219|NCT01849549|Other|MRI|Anatomical, diffusion, and/or functional MRI
16141220|NCT01849536|Device|SENSIMED Triggerfish®|
16141221|NCT01849523|Behavioral|Web-based information and support|
16141222|NCT01849510|Radiation|hypofractionated 12x3 Gy + integrated boost 12x4 Gy|hypofractionated, homogeneous radiation (12x3 Gy) with simultaneously administrated, integrated boost (12x4 Gy) mediated by IGRT & hfSRT
16141223|NCT01849510|Radiation|hypofractionated 10x3 Gy|hypofractionated, homogeneous radiation (10x3 Gy)
16141224|NCT01849497|Biological|Evolocumab Pre-filled Syringe|Evolocumab subcutaneous injection via a single use, disposable pre-filled syringe.
16141225|NCT01849497|Biological|Evolocumab AI/pen|Evolocumab subcutaneous injection via a handheld mechanical (spring-based) autoinjector/pen.
16141226|NCT01849484|Radiation|Radiation according to indication with hippocampal sparing|Performed with hippocampal sparing Meningioma-total dose up to 50.4 Gy (+ additional boost up to 59.4 Gy) Hypophyseal adenoma - total dose up to 50.4 Gy (+additional boost up to 54 Gy) SCLC (prophylactic cranial irradiation) - total dose up to 36.0 Gy
16141227|NCT01849484|Radiation|Radiation according to indication without hippocampal protection|Performed with hippocampal sparing Meningioma-total dose up to 50.4 Gy (+ additional boost up to 59.4 Gy) Hypophyseal adenoma - total dose up to 50.4 Gy (+additional boost up to 54 Gy) SCLC (prophylactic cranial irradiation) - total dose up to 36.0 Gy
16141228|NCT01849471|Other|questionnaires|patients receive questionnaires regarding socioeconomic aspects before, during and after therapy
16141229|NCT01849458|Device|BioFiber|Subjects implanted with BioFiber or BioFiber-CM Scaffold
16141230|NCT01849445|Procedure|Intensive physiotherapy|Participants will visit hospital for physiotherapy sessions once a week for 6 weeks in addition to completing prescribed exercises twice a week at home on their own.
16141231|NCT01849445|Other|Home physiotherapy exercises|Patients will be asked to complete prescribed exercises at home on their own 3 times a week for 6 weeks.
16141232|NCT01849419|Drug|Within-subjects (MDMA)|This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received a single dose of MDMA (0.75, 1.5 mg/kg) on two session, oxytocin (20 IU) as an active control on one session (see second Intervention), and placebo one session (see third intervention).
16141235|NCT01849406|Drug|nasal spray Budesonide|one week therapy of nasal budesonide twice per day
16141236|NCT01849406|Drug|Nasal spray Normal Saline|one week therapy of nasal normal saline twice per day
16141237|NCT01849393|Other|Questionnaire|Participants who consent to participate in this study will complete a short questionnaire. The survey will be completely anonymous (not matched with the participant's name). Estimated time to complete the survey is 10-20 minutes.
16141238|NCT01849380|Drug|S-1|S-1(SuLi, QILU Pharmaceutical co.ltd ) was given at a standard dose of 40 mg/m2 twice daily in cycles of 14-day consecutive administration
16141239|NCT01849380|Drug|5-FU|5-FU was given at a standard dose of 500mg/m2 (infusion, d1, d8 respectively),
16141240|NCT01849367|Device|Eldith Neuroconn tDCS device|
16141241|NCT01849341|Drug|Roflumilast alternated days|500 mcg per day on alternate days (roflumilast 500μg eod) for 2 weeks
16141242|NCT01849341|Drug|Roflumilast 500 mcg per day|
16141243|NCT01849315|Behavioral|AKIDS II|Physically active intervention
16141244|NCT01849302|Dietary Supplement|Beverages varying in macronutrient content on appetite|In this randomized, within-subject study, subjects are asked to consume 7 iso-energetic and iso-volumetric beverages as breakfast (20% of estimated energy requirements) with varying distribution of macronutrients. The objective is to identify the optimal protein quantity or macronutrient distribution on suppressing appetite.
16141245|NCT01849289|Drug|Insulin Degludec|Administered subcutaneously (under the skin), dose individually adjusted, once daily in combination with metformin at the unchanged, stable, pre-randomisation dose level and dosing frequency.
16141246|NCT01849289|Drug|Insulin Glargine|Administered subcutaneously (under the skin), dose individually adjusted, once daily in combination with metformin at the unchanged, stable, pre-randomisation dose level and dosing frequency.
16141247|NCT01849276|Drug|metformin hydrochloride|Given orally
16141248|NCT01849276|Drug|cytarabine|Given IV
16141249|NCT01849276|Other|laboratory biomarker analysis|Correlative studies
16141250|NCT01849263|Drug|Ibrutinib|Given PO
16141251|NCT01849263|Other|Laboratory Biomarker Analysis|Correlative studies
16141252|NCT01849250|Drug|Docosahexaenoic Acid|Given PO
16141253|NCT01849250|Other|Laboratory Biomarker Analysis|Correlative studies
16141254|NCT01849250|Other|Placebo|Given PO
16141255|NCT01849237|Genetic|Mesenchymal stromal cells|MSCs intravenous infusion of 1-2 millions/kg/day will be performed not more than 10 hs after onset of septic shock in patients with severe neutropenia(≤ 1x10^9/l).
16141256|NCT01849237|Drug|Standard therapy of septic shock|Antibiotic therapy Fluid therapy Vasopressors Inotropic therapy Steroids
16141257|NCT01849224|Other|Pelvic and lower extremity exercise|
16141258|NCT01849211|Drug|rocuronium|
16141259|NCT01849198|Device|accelerometry m. trapezius and m. adductor pollicis|
16141260|NCT01849185|Other|Food supplement|
16141261|NCT01849172|Other|electroacupuncture|Stick adhesive tapes to all points. For ST25, EX-CA1 and RN4, insert the needle vertically through the pads and the skin, and then slowly and vertically penetrate through the layer of fatty tissue, into the muscles of the abdominal wall .For RN4, manipulate the needle with an even lifting, thrusting and twisting method slightly for 3 times. Insert the needle vertically at SP6 to a depth of 1 cm. Manipulate the needle with an even lifting, thrusting and twisting method slightly for 3 times to reach de-qi. Put the electric stimulator on the pair of EX-CA1 and ST25 points with a dilatational wave, 10/50 Hz, 0.5-1.0mA. To turn on the current intensity till the abdomen shivers. The same manipulation methods for RN4 and SP6 will be given every 10 minutes (3 times in all).
16141262|NCT01849172|Other|sham electroacupuncture|"Non-points proximate to RN4 (P1), EX-CA1(P2)，ST25 (P3) and SP6 (P4) (double sides) are used.P1 and P3 are at the sites 1 cm (outward in horizontal direction) proximate to RN4 and ST25 respectively. P2 is 2 cm (outward in horizontal direction) proximate to EX-CA1. P4 is at the middle site of the spleen meridian and the kidney meridian (backward in horizontal direction proximate to SP6).
~Stick adhesive tapes to all points. Blunt needles will be used to be inserted to but not piercing the skin. Even lifting, thrusting and twisting manipulation methods will be given for each non-point for 3 times. Put the sham electric stimulator on the pair of P2 and P3 with the same parameters as the acupuncture group. But there is no current intensity actually."
16141263|NCT01849159|Biological|Mesenchymal stem cells|Intravenous infusion of MSC suspension, pre-conditioned under 1% oxygen, in the amount of 200 mln. cells per 400 mL of sodium chloride physiological solution
16141264|NCT01849159|Other|Reference therapy: 400 mL of 0.9% NaCl solution|
16141265|NCT01849146|Drug|Adavosertib|Given PO
16141266|NCT01849146|Radiation|Radiation Therapy|Undergo radiation therapy
16141267|NCT01849146|Drug|Temozolomide|Given PO
16141268|NCT01849133|Radiation|external fractionated radiotherapy|conventional external beam radiotherapy
16141269|NCT01849133|Radiation|intraoperative radiotherapy|Intraoperative radiotherapy (IORT). Total delivered dose 21Gy (Gray), 90% isodose
16141270|NCT01849120|Device|EQUANOX Advance 8004CB sensor|The EQUANOX Advance 8004CB sensors placed in peripheral sites of neonates and infants will be used to detect peripheral perfusion and oxygen delivery.
16141271|NCT01849107|Biological|Plasma citrulline|
16141272|NCT01849094|Drug|Milrinone 6mg|Administration of study medications, PK sampling If Part B - add on 6 hour haemodynamic invasive measurements
16141273|NCT01849094|Drug|milrinone 10mg ER|Administration of study medications, PK sampling If Part B - add on 6 hour haemodynamic invasive measurements
16141274|NCT01849094|Drug|milrinone 14mg|Administration of study medications, PK sampling If Part B - add on 6 hour haemodynamic invasive measurements
16141275|NCT01849081|Device|CPAP|Subjects in the intervention arm will be treated with continuous positive airway pressure (CPAP) device at night.
16141276|NCT01849081|Behavioral|LIfestyle|Subjects will undergo 12 weeks of dietary counseling.
16141277|NCT01849068|Drug|Ezetimibe|Ezetimibe 10 mg/d for 12 weeks
16141278|NCT01849068|Drug|Placebo|Placebo for 12 weeks
16141279|NCT01849055|Drug|Placebo|Administered orally
16141280|NCT01849055|Drug|LY3023703|Administered orally
16141281|NCT01849055|Drug|Celecoxib|Administered orally
16141282|NCT01849042|Drug|Ebixa|add-on of Ebixa oral pump already receiving donepezil with stable dosage
16141283|NCT01849042|Drug|donepezil|
16141412|NCT01848002|Drug|placebo|For 5 consecutive days, one daily dose of placebo was administered intravenously (IV) to two subjects in each dose group (10 or 25 U/kg).
16141467|NCT01847651|Other|MRI brain and spectroscopy|Both Arms, all 3 visits at 0, 4 and 12 weeks
16141284|NCT01849029|Behavioral|Cognitive Processing Therapy-Cognitive|Cognitive Processing Therapy-Cognitive (CPT-C) uses education about trauma reactions, emotional processing, and cognitive strategies to reduce trauma-related cognitive distortions. CPT is a manualised 12 session cognitive behavioral treatment for PTSD which offers an alternative to purely exposure based interventions. CPT has a smaller exposure component than imaginal exposure therapy and is therefore potentially more acceptable to clients or practitioners seeking alternatives to purely exposure focused treatments. CPT-C omits the written trauma account, and includes more practice of cognitive techniques during the sessions. The treatment was developed for twice weekly sessions over 6 weeks. It also directly targets associated problems such as depression, guilt and anger.
16141285|NCT01849016|Drug|N-Acetylcysteine|
16141286|NCT01849016|Drug|Placebo|
16141287|NCT01849003|Drug|GS-6615|GS-6615 tablet(s) administered orally
16141288|NCT01848990|Drug|Commercial Hylenex® recombinant (hyaluronidase human injection)|
16141289|NCT01848990|Drug|Precommercial Hylenex recombinant (hyaluronidase human injection)|
16141290|NCT01848990|Drug|Insulin lispro|
16141291|NCT01848990|Drug|Insulin aspart|
16141292|NCT01848990|Drug|Insulin glulisine|
16141293|NCT01848977|Device|vascular occlusion test|Using Invos® probe attacted to one thenar muscle, tissue oxgyenation is measured by VOT.
16141294|NCT01848977|Device|vascular occlusion test|Using Inspectra™ probe attacted to another thenar muscle, tissue oxgyenation is measured by VOT.
16141295|NCT01848964|Device|Clinical and instrumented measurements|"Clinical examination will include stump pain, wound, scar and unusual shape.
~Questionnaire will include satisfaction scale (SatPro), comfort scale (SCE), and functional scale (PPA-LCI)
~After installing the sensors on the stump, the patient will put his prosthesis on and will perform the following tasks: gait, sitting and standing posture and gait initiation.
~Pressure repartition at the stump-socket interface will be assessed with the 14 flat sensors.
~Gait parameters will be assessed with the OptoGait device. Standing posture and gait initiation parameters will be assessed with a force-plate."
16141296|NCT01848951|Drug|Epidural|
16141297|NCT01848951|Drug|TAP Block|
16141298|NCT01848938|Behavioral|Smartphone treatment with PFMT|A smartphone application with information on SUI, life style information, different programmes of PFMT with increasing severity, possibility to save statistics on training. The treatment period is three months
16141299|NCT01848925|Biological|SANGUINATE™|40 mg/mL intravenous infusion.
16141300|NCT01848925|Drug|Hydroxyurea|Standard of care for Sickle Cell treatment, 15 mg/kg.
16141301|NCT01848912|Device|Zephyr Biopatch Device|
16141302|NCT01848899|Drug|Iodixanol|contrast media used during coronary angiography
16141303|NCT01848899|Drug|Ioxaglate|contrast media used during coronary angiography
16141304|NCT01848899|Drug|Bivalirudin|A direct thrombin inhibitor
16141305|NCT01848886|Procedure|Endoscopic radial artery harvest|Radial artery harvest is performed as an endoscopic procedure.
16141306|NCT01848886|Procedure|Open radial artery harvest|Radial artery harvest is performed as an open procedure.
16141307|NCT01848886|Procedure|Mammarioradial graft (Y-graft)|The radial artery is used as an composite graft positioned on the internal mammarian artery.
16141308|NCT01848886|Procedure|Aortoradial graft (Free RA)|The radial artery is used as an free graft positioned on the aorta.
16141309|NCT01848873|Drug|Amlodipine|amlodipine 5mg daily
16141310|NCT01848873|Drug|amlodipine-FA tablet, low dose group|5mg amlodipine combined with 0.4 mg of folic acid, daily.
16141311|NCT01848873|Drug|amlodipine-FA tablet ,high dose group|amlodipine 5mg and folic acid 0.8mg daily
16141312|NCT01848860|Procedure|Thoracoscopic bullectomy and pleural abrasion|Thoracoscopic bullectomy and pleural abrasion will be performed in a standard fashion under general anesthesia using intubated one-lung ventilation. When blebs are identified, they will be grasped with the ring forceps and excised with an endoscopic stapler. Blind apical stapling was done at the most suspicious area if no bleb could be identified. Thoracoscopic pleural abrasion will be performed at the parietal pleura above the 5th intercostal space by inserting the dissector with a strip of diathermy scratch pad through the port sites in all patients.
16141313|NCT01848860|Biological|Mesh coverage of the staple line|Absorbable mesh coverage of the staple line will be performed in the mesh group after thoracoscopic bullectomy in the mesh group
16141314|NCT01848847|Procedure|Hysteroscopy|
16141315|NCT01848834|Biological|Pembrolizumab|IV infusion
16141316|NCT01848821|Device|OASIS Ultra|Porcine derived intestinal submucosa
16141317|NCT01848821|Device|Wound VAC Standard Therapy|Negative pressure wound device aka wound VAC will be placed on the standard therapy half of the wound
16141318|NCT01848808|Dietary Supplement|Wobenzym PS|
16141319|NCT01848808|Dietary Supplement|Placebo|
16141320|NCT01848795|Device|EndoBarrier Gastrointestinal Liner|Endoscopy placement of EndoBarrier, and clinical and biochemical follow up
16141321|NCT01848795|Device|Easy life balloon|Endoscopy placement of EndoBarrier, and clinical and biochemical follow up
16141322|NCT01848782|Behavioral|interpretation of the abstract of the systematic review|
16141323|NCT01848769|Drug|CHF1535 pMDI + AC Plus|Four inhalations for a total dose of BDP/FF 200/24 mcg
16141324|NCT01848769|Drug|BDP + AC Plus|Four inhalations for a total dose of BDP 200 mcg
16141325|NCT01848769|Drug|Formoterol + AC Plus|Four inhalations for a total dose of Formoterol 24 mcg
16141326|NCT01848756|Drug|SNX-5422|Capsule(s) dosed every other day for 21 days (total = 11 doses), out of a 28-day treatment cycle.
16141327|NCT01848743|Drug|Tenofovir|
16141328|NCT01848743|Drug|lamivudine|
16141329|NCT01848730|Drug|CNV2197944|
16141330|NCT01848730|Drug|Placebo|
16141331|NCT01848717|Device|MINTLIFT®|
16141332|NCT01848704|Behavioral|interpretation of the abstract|
16141333|NCT01848691|Other|Measurement of carbon monoxide level in exhaled breath|Measurement of end-tidal carbon monoxide concentration
16141334|NCT01848665|Drug|Indomethacin|
16141335|NCT01848665|Drug|Placebo|
16141336|NCT01848652|Drug|infusion of MYOCET|
16141413|NCT01847989|Drug|catridecacog|Single doses of rFXIII administered intravenously (IV) to eight subjects in each of the five dose groups (2, 5, 10, 25 and 50 U/kg).
16141468|NCT01847651|Other|MRI leg cross section|Both Arms, all 3 visits at 0, 4 and 12 weeks
16141337|NCT01848639|Drug|Spironolactone|After a month in run-in period under 25 mg per 2 days of spironolactone administered per os in practice after dialysis session three times a week, patients will be randomized to spironolactone. The dose should be increased to 25 mg once daily and could be adjusted in using an algorithm used in the EPHESUS and EMPHASIS-HF trials.
16141338|NCT01848639|Drug|Placebo|After a month in run-in period under 25 mg per 2 days of spironolactone administered per os in practice after dialysis session three times a week, patients will be randomized to placebo. The dose should be increased to 25 mg once daily and could be adjusted in using an algorithm used in the EPHESUS and EMPHASIS-HF trials.
16141339|NCT01848613|Drug|Vinorelbine|
16141340|NCT01848600|Behavioral|interpretation of the abstract|the intervention consist to interpret the results of the meta-analysis after reading the abstract.
16141341|NCT01848587|Other|acupuncture|
16141342|NCT01848587|Other|usual care|
16141343|NCT01848574|Other|standardized multifaceted information procedure to improve patients' comprehension|
16141344|NCT01848548|Procedure|Superior Laryngeal Nerve Block using the Thyrohyoid Membrane as an Anatomic Landmark|The needle is introduced just lateral to midline above the thyroid notch in a slightly medial direction so as to enter the thyrohyoid membrane, and inserted about 1-1.5 cm. Three milliliters of 2% lidocaine is injected.
16141345|NCT01848535|Dietary Supplement|GOS addition|GOS (2.5g 3x per day) supplemented during 12 days
16141346|NCT01848535|Dietary Supplement|Placebo|Maltodextrine(2.5g 3x per day) supplemented during 12 days
16141347|NCT01848509|Device|With teletransmission|Teletransmission of alerts
16141348|NCT01848496|Procedure|Gingival displacement|Gingival displacement is a dental procedure that allows exposure of the finishing line of a dental cavity in order to produce a well-adapted restoration.
16141349|NCT01848483|Behavioral|AIDS EPC Package plus MI|"Motivational Interviewing: In MI session #1, the nurse will set the agenda & ask the participant to discuss any adjustments to the AIDS diagnosis. In sessions #2 - 4, the participant will be asked to set the agenda related to current concerns. In sessions #3 & 4, the nurse will also introduce advance care planning.
~EPC Package: Participants will be seen by palliative care providers, for approximately 30 minutes each, in the following order: 1) Chaplain: introduces the concept of EPC clinic & conducts a spiritual evaluation/intervention as needed. 2) Social worker: conducts an evaluation/intervention as needed. 3) Psychologist: conducts an evaluation/intervention as needed. 4) Palliative Care Physician: conducts symptom management, medication reconciliation & coordination of care."
16141350|NCT01848483|Other|Standard of Care (SOC)|The routine standard of care provider visit occurs in the following order. The vital signs are taken and the participant sees the nurse to review medications. The provider visits are scheduled for approximately 30 minutes, except for a new patient or patient with complex medical needs. The provider conducts a history to elicit symptoms, health problems, concerns, and a physical exam, then orders labs or immunizations; and referrals to subspecialty clinics. Medications are prescribed or renewed. The patient then receives a follow-up appointment, typically every 3 months for a stable patient. If the patient starts Antiretroviral therapy (ART), an appointment to the nurse educator is required. Typically, the patient will have 1- 2 visits to the nurse educator to begin medications and follow-up for side-effects.
16141351|NCT01848470|Drug|CG400549 640mg|multiple oral doses of 640 mg CG400549 (n=6) BID for 5 days (Days 1-5) and a final dose on Day 6 in the fed state
16141352|NCT01848470|Drug|CG400549 320 mg|multiple oral doses of 320 mg CG400549 (n=6) QD for 5 days in the fed state
16141353|NCT01848470|Drug|CG400549 640 mg|multiple oral doses of 640 mg CG400549 (n=6) QD for 5 days in the fed state
16141354|NCT01848470|Drug|CG400549 960 mg|multiple oral doses of 960 mg CG400549 (n=6) QD for 5 days in the fed state
16141355|NCT01848470|Drug|Placebo 640mg|multiple oral doses of 640 mg placebo (n=2) BID for 5 days (Days 1-5) and a final dose on Day 6 in the fed state
16141356|NCT01848470|Drug|Placebo 320mg|multiple oral doses of 320 mg placebo (n=2) QD for 5 days in the fed state
16141357|NCT01848470|Drug|placebo 960 mg|multiple oral doses of 960 mg placebo (n=2) QD for 5 days in the fed state
16141358|NCT01848470|Drug|Placebo 640mg|multiple oral doses of 640 mg placebo (n=2) QD for 5 days in the fed state
16141359|NCT01848457|Drug|Pantoprazole|0.3 mg/kg IV over 15 min immediately prior to cisplatin as a loading dose on days 1 & 2 followed by 1.3 mg/kg IV infused over 4 h concurrent with the 4 h cisplatin infusion on days 1 & 2 of treatment Cycles 1 & 2 (Treatment Arms 1, 3) OR Cycles 3 & 4 (Treatment Arms 2, 4)
16141360|NCT01848457|Drug|High-dose methotrexate infusion duration|High-dose methotrexate (12 g/sq m, maximum dose 20 g) will be infused over 4 hours or 12 hours
16141361|NCT01848444|Other|Breastmilk|to measure levels of contaminants in human breastmilk samples
16141362|NCT01848379|Procedure|ADT+FD|
16141363|NCT01848379|Procedure|FD|
16141364|NCT01848366|Device|Biowave Treatment|Twelve weekly treatments
16141365|NCT01848353|Behavioral|Exercise training|All participants will perform exercise training at the wellness center. Exercise duration and intensity will be recorded with heart rate monitors.
16141366|NCT01848340|Drug|GSK1265744B (sodium salt) containing 14C-GSK1265744B|A white to slightly colored nonsterile crystalline powder for oral solution
16141367|NCT01848340|Drug|150 mg GSK1265744B|This is GSK1265744B (sodium salt of GSK1265744), lactose monohydrate, Microcrystalline cellulose, hypromellose, sodium lauryl sulfate, croscarmellose sodium, magnesium stearate, Opadry film-coating, white OY-S-28876 tablet
16141368|NCT01848340|Drug|Placebo|Microcrystalline cellulose, Opadry film-coating, white OY-S-28876 tablet
16141369|NCT01848327|Dietary Supplement|Caprylic Triglyceride|Caprylic Triglyceride is a medical food that is used for the dietary management of the metabolic processes associated with mild to moderate Alzheimer's disease.
16141370|NCT01848327|Dietary Supplement|Placebo|Placebo (40 gram packet orally once a day for 90 days)
16141371|NCT01848314|Procedure|Renal Denervation|Flowmeasurements will be performed before and after renal denervation
16141372|NCT01848301|Device|Optical Coherence Tomography|OCT imaging of the LAD coronary artery
16141373|NCT01848301|Drug|Acetylcholine|Infusion in the coronary artery to study endothelial function
16141374|NCT01848301|Procedure|Brachial Artery Flow Mediated Dilation|Assess peripheral brachial artery endothelial function
16141414|NCT01847989|Drug|placebo|Single doses of placebo administered intravenously (IV) to two subjects in each of the five dose groups (2, 5, 10, 25 and 50 U/kg).
16141375|NCT01848288|Device|CENTURION® Vision System (CVS)|Phacoemulsification aspiration platform, with configuration consisting of Centurion® Vision System Phaco Emulsifier Aspirator, 45° Balanced ultrasonic tip, and INTREPID Ultra Infusion Sleeve, for use during routine cataract extraction by phacoemulsification with intraocular lens implantation.
16141376|NCT01848288|Device|INFINITI® Vision System (IVS)|Phacoemulsification aspiration platform, with configuration consisting of Infiniti® Vision System Phaco Emulsifier Aspirator, 45° Mini Flared Kelman tip, and Ultra Infusion Sleeve, for use during routine cataract extraction by phacoemulsification with intraocular lens implantation.
16141377|NCT01848275|Device|Thermocool®Rcatheter|The full length RDN was performed discretely from distal to proximal by point to point using Thermocool®Rcatheter
16141378|NCT01848275|Device|Thermocool®Rcatheter|The proximity renal denervation was performed discretely at 10-15 mm of proximal renal artery, using Thermocool®Rcatheter
16141379|NCT01848262|Procedure|ECALMIST|Surfactant administration via 17 (5 French) gauge, 133 mm length vascular catheter. 5 ml/kg will be drawn up in a 5 or 10 ml syringe. The vascular catheter will be inserted through the vocal cords under direct vision using a standard laryngoscope with the appropriate blade for gestational age. The procedure will be done without removing the NCPAP. A bolus of surfactant of 0.25-0.5 ml will be administered, after observing the surfactant moving up and down as indication of accurate intubation of the trachea. The surfactant will be slowly injected by small pulses of 0.25-0.5 ml over 20-30 seconds, each bolus with 10 seconds apart. At the end of the procedure, the operator will flush the catheter with 0.5 ml of air before removing the catheter.
16141380|NCT01848262|Procedure|InSure|Patients who will receive surfactant via this technique will have their NCPAP removed and then they will be orally intubated with a standard endotracheal tube (ETT) using standard endotracheal intubation procedures using appropriate size ETT according to the birth weight. Bovine surfactant will be administered through the ETT using the same technique described above for arm 1. Manual lung inflation using a Jackson -Rees anesthesia bag at 20/5-cm H2O pressure will be performed during the surfactant instillation after which the patient will be extubated promptly as per the discretion of the neonatal team. Immediately following extubation, nCPAP support will be recommenced. No premedication, such as sedation or atropine, will be used during either procedure.
16141381|NCT01848236|Dietary Supplement|Vitamin D2|Ergocalciferol vitamin D2
16141382|NCT01848236|Dietary Supplement|Vitamin D3|Cholecalciferol vitamin D2
16141383|NCT01848210|Drug|Coumarin/troxerutin|Coumarin + troxerutin fixed-dose combination tablets
16141384|NCT01848210|Drug|Placebo|Coumarin + troxerutin placebo-matching tablets
16141385|NCT01848197|Drug|paclitaxel|
16141386|NCT01848184|Device|PARIETEX™ Composite Ventral Patch|PARIETEX™ Composite Ventral Patch for ventral hernia repair
16141387|NCT01848171|Drug|L-thyroxine|
16141388|NCT01848158|Device|acupuncture|Patients randomized to active treatment will receive acupuncture treatment with press needles (small acupuncture needles manufactured with attached bandage that makes the needle flush with skin) at sites GV 24.5 or GV20, Ht 7 or Ht 3, Ki 3, Lr 3, LI 4 or LI 11, Lu 7 or Lu 5, Sp6, ST 36, using up to 15 points per patient three days per week for the duration of mechanical ventilation (maximum of 14 calendar days from the time of the first acupuncture treatment). We will also apply a seed magnet at ear shen men position for 4 hours on treatment days.
16141389|NCT01848158|Device|sham acupuncture|Patients randomized to sham treatment will receive sham acupuncture with similarly appearing bandages placed without press needles attached at sites GV 24.5 or GV20, Ht 7 or Ht 3, Ki 3, Lr 3, LI 4 or LI 11, Lu 7 or Lu 5, Sp6, ST 36, using up to 15 points per patient three days per week for the duration of mechanical ventilation (maximum of 14 calendar days from the time of the first acupuncture treatment). We will also apply a similarly appearing bandage without seed magnet underneath at ear shen men position for 4 hours on treatment days.
16141390|NCT01848145|Drug|Ofatumumab|The first dose of ofatumumab administered on Day 1 will be 300 mg to minimize infusion reactions. If the initial 300 mg dose of ofatumumab is well-tolerated, without occurrence of any infusion-associated AEs of >= grade 3, on Day 3 ofatumumab will increase to 1000 mg IV. If the Day 3 dose was well-tolerated (i.e., no infusion-associated AE >= grade 3), on Day 8 the ofatumumab dose will escalate to 2000 mg IV. To achieve the primary endpoint for this study, 20% of the 2000 mg ofatumumab dose only will be administered over the first 30 minutes and if tolerated the remaining 80% of the dose will be infused over the remaining 1.5/hours of each treatment. Ofatumumab doses, weeks 3-8, will remain at 2000 mg IV with no further dose escalations. If the Day 8 (Week 2) dose is tolerated all subsequent doses may be infused in the same manner.
16141391|NCT01848132|Drug|Bortezomib|Bortezomib: subcutaneous, 1,3 mg/m2, day 1, 8, 15.
16141392|NCT01848132|Drug|Rituximab|Rituximab: intravenous, 375 mg/m2, day 1
16141393|NCT01848132|Drug|Cyclophosphamide|Cyclophosphamide: intravenous, 750 mg/m2, day 1
16141394|NCT01848132|Drug|Doxorubicin|Adriamycin:intravenous, 50 mg/m2, day 1
16141395|NCT01848132|Drug|Prednisone|Prednisone: oral, 100 mg, days 1-5
16141396|NCT01848132|Drug|Vincristine|Vincristine: intravenous, 1,4 mg/m2, day 1
16141397|NCT01848119|Drug|Gabapentin|
16141398|NCT01848119|Drug|lactose|
16141399|NCT01848106|Drug|pegnivacogin/anivamersen|
16141400|NCT01848106|Drug|Bivalirudin|
16141401|NCT01848093|Other|sputum collection|collecting of spontaneous sputum from the patient
16141402|NCT01848080|Behavioral|Tai Chi based exercise program|A Tai Chi based exercise program that uses movement repetition favoring directional adjustments in space, supervised by a physiotherapist, has been shown to be effective in improving balance in individuals with physical impairments, including those presenting with sequelae following a stroke.
16141403|NCT01848067|Drug|Alisertib|Given PO
16141404|NCT01848067|Drug|Abiraterone acetate|Given PO
16141405|NCT01848067|Drug|Prednisone|Given PO
16141406|NCT01848054|Drug|Buprenorphine/naloxone sublingual tablets|Advanced-formulation buprenorphine/naloxone sublingual tablets
16141407|NCT01848054|Drug|Buprenorphine|Buprenorphine sublingual tablets
16141408|NCT01848041|Drug|RVL-1201|RVL-1201 0.1% Ophthalmic Solution
16141409|NCT01848041|Drug|RVL-1201 Vehicle Placebo|RVL-1201 Vehicle Placebo
16141410|NCT01848015|Other|detection of CTCs|
16141411|NCT01848002|Drug|catridecacog|For 5 consecutive days, one daily dose of rFXIII was administered intravenously (IV) to eight subjects in each dose group (10 or 25 U/kg).
16141614|NCT01846520|Procedure|quality-of-life assessment|Ancillary studies
16141416|NCT01847963|Drug|Sindhuvallathy mezhugu ( SVM)|500 mg capsules per oral twice daily for 45 days a Siddha classical literature preparation
16141417|NCT01847963|Drug|Kalladaippu Kudineer (KK) -|130 ml decoction twice daily-per oral for 45 days, a Siddha classical literature preparation
16141418|NCT01847950|Dietary Supplement|Short-chain fructo-oligosaccharides|Short-chain fructo-oligosaccharides are consummed at 5g/day for 6 weeks
16141419|NCT01847950|Dietary Supplement|Maltodextrin|
16141420|NCT01847924|Drug|MLC901|24 weeks intervention with orally MLC901. 2 capsules 3 times a day
16141421|NCT01847924|Drug|Placebo|24 weeks intervention with orally placebo. 2 capsules 3 times a day
16141422|NCT01847911|Other|Self instructed video learning|A complete video lesson of neonatal resuscitation including initial resuscitative maneuvers and administration of ventilation with a SIB and a T-piece resuscitator presented in the primary language of the participating center or university (Spanish or English). A portable kit with a newborn mannequin will be provided for independent video guided practice during the session.
16141423|NCT01847911|Other|instructor training|a pre-validated OSCE neonatal resuscitation program
16141424|NCT01847898|Procedure|Vertebral Body Stenting (VBS)|Vertebral Augmentation with a Stent
16141425|NCT01847898|Procedure|Balloon Kyphoplasty|Vertebral Augmentation with a Balloon (device not specified)
16141426|NCT01847885|Device|Smartpatch Peripheral Nerve Stimulation (PNS) System|"The Smartpatch System is an Investigation Device which delivers mild electrical stimulation to the muscles in the shoulder. The Smartpatch System includes a small wire (called a Lead) that is placed through the skin into the muscle of the shoulder. It also includes a device worn on the body that delivers stimulation (called the Smartpatch Stimulator)."
16141427|NCT01847872|Drug|IPV IM Needle|
16141428|NCT01847872|Drug|IPV ID Needle|
16141429|NCT01847872|Drug|IPV IM Device|
16141430|NCT01847872|Drug|IPV ID Device|
16141431|NCT01847859|Procedure|Ultrasound examination by nurses|Focused examination of the pleural space and inferior vena cava.Reference method: Cardiologists performed ultrasound examinations.
16141432|NCT01847846|Device|CPAP mask - prototype|prototype mask, wore for all sleeps for 4 and 8 weeks (as randomly selected). Mask to be used in conjunction with participant's usual prescribed CPAP settings.
16141433|NCT01847833|Other|MRI scan|
16141434|NCT01847820|Device|AmniSure ROM test|Comparison of AmniSure ROM test to clinical diagnosis of ROM.
16141435|NCT01847807|Drug|low dose Astragalus|
16141436|NCT01847807|Drug|high dose astagalus|
16141437|NCT01847794|Device|Cell Search® CTC epithelial kit|"Collect peripheral blood sample of 50 gastric cancer patients pre-chemotherapy and post two cycles of chemotherapy(response evaluation).
~Blood samples will be transferred to central lab to detect HER2 positive CTCs by Cellsearch epithelial kit.
~Tumor response evaluation will be performed after two cycles of chemotherapy by CT/MRI based on RECIST. Clinical data, including tumor stage, metastastic organ, chemotherapy regimen, objective response, progression free survival, overall survival, etc, will be collected according to study protocol."
16141438|NCT01847781|Biological|Prevenar13|
16141439|NCT01847768|Biological|GMP-grade HRV-39|Experimental rhinovirus infection: an FDA approved, GMP-grade HRV-39 stock (gift from Dr. Ronald B. Turner, University of Virginia), which has now been approved by Health Canada for human experimental use, will be used in this study.
16141440|NCT01847768|Procedure|Bronchoalveolar Lavage|
16141441|NCT01847768|Drug|Methacholine Inhalation Challenge|The purpose of this test is to determine if lung airways narrow by more than 20%, which confirms an asthma diagnosis.
16141442|NCT01847768|Procedure|Nasal Lavage|
16141443|NCT01847768|Procedure|Nasal Scrapings|This process uses a rhinoprobe to gently scrape the mucosal lining of the nose
16141444|NCT01847768|Procedure|Bronchial Brushings|
16141445|NCT01847768|Procedure|Lung Mucosal Biopsy|
16141446|NCT01847768|Procedure|Allergen Skin Prick Testing|For the purposes of this study, allergy skin testing will be done with the following aero-allergens: cat epidermis, dog epidermis, horse, grass mix, tree mix, weed mix, ragweed and house dust mite, along with a histamine positive control and a buffer & glycerol negative control.
16141447|NCT01847768|Procedure|Venipuncture|Peripheral blood for assessment of neutralizing antibodies to HRV-39
16141448|NCT01847768|Procedure|Bronchoscopy|A small flexible tube the size of a pencil, with a video-camera built into the tip (called a bronchoscope), will be inserted through the nose or mouth and down into the lungs.
16141449|NCT01847768|Procedure|Spirometry|
16141450|NCT01847755|Drug|Oxygen at 1.5 ATA (atmospheres absolute).|Each patient will undergo 5 times-a-week Hyperbaric treatments to 1.5 ATA (atmospheres absolute) for up to 120 treatments. Treatment in hyperbaric chamber will be approximately 60 minutes. At specified intervals 40,80,120, patient will be assessed by Spect scan and cognitive assessments to provide outcome measure data. Pt will have a 3 month post treatment follow up assessment.
16141451|NCT01847742|Behavioral|Eye Movement Desensitization and Reprocessing Therapy|
16141452|NCT01847703|Procedure|Robotic surgery|Minimal invasive surgery performed with daVinci robotic system
16141453|NCT01847703|Procedure|Abdominal surgery|Current gold standard
16141454|NCT01847690|Drug|Hydrocortisone|Cortef 5 mg tablets per os, 2x5 mg, one day, one time
16141455|NCT01847677|Drug|Bevacizumab|
16141456|NCT01847677|Drug|Paclitaxel|
16141457|NCT01847677|Drug|Carboplatin|
16141458|NCT01847664|Drug|Rifamycin SV-MMX® 400 mg b.i.d.|
16141459|NCT01847664|Drug|Rifamycin SV-MMX® 600 mg t.i.d.|
16141460|NCT01847664|Drug|Rifamycin SV-MMX® Placebo|
16141461|NCT01847651|Procedure|Vastus Muscle Biopsy|Both Arms, all 3 visits at 0, 4 and 12 weeks
16141462|NCT01847651|Drug|LOLA or placebo|Hepa-Merz Granulat 3000 Hepa-Merz granules 3g (Each 5g sachet contains 3g of L-ornithine L-aspartate) L-ornithine L-aspartate LOLA Randomised to a daily dose 18g per day, two sachets of Hepa-Merz granules three times a day (or placebo)for 12 weeks
16141463|NCT01847651|Other|Cognitive assessment (PHES)|Both Arms, all 3 visits at 0, 4 and 12 weeks
16141464|NCT01847651|Other|Cognitive Assessement (Cogstate)|Both Arms, all 3 visits at 0, 4 and 12 weeks
16141465|NCT01847651|Other|blood and urine sampling|Both Arms, all 3 visits at 0, 4 and 12 weeks
16141466|NCT01847651|Other|Nutritional assessment|Both Arms, all 3 visits at 0, 4 and 12 weeks
16141469|NCT01847651|Other|Functional MRI (working memory and attention tasks)|Both Arms, all 3 visits at 0, 4 and 12 weeks
16141470|NCT01847638|Drug|Prolensa (bromfenac 0.07%)|Comparison of Prolensa (bromfenac ophthalmic solution) 0.07% QD vs. Ilevro (nepafenac ophthalmic suspension) 0.3% QD for Treatment of Ocular Inflammation Associated with Cataract Surgery
16141471|NCT01847638|Drug|Ilevro (nepafenac 0.3%)|Comparison of Prolensa (bromfenac ophthalmic solution) 0.07% QD vs. Ilevro (nepafenac ophthalmic suspension) 0.3% QD for Treatment of Ocular Inflammation Associated with Cataract Surgery
16141472|NCT01847625|Other|simulator|
16141473|NCT01847612|Procedure|indocyanine green fluorescent cholangiography|
16141474|NCT01847612|Drug|methylene blue|
16141475|NCT01847599|Other|Educational Intervention to enhance the adherence of Patient treated by capecitabine +/- Lapatinib|
16141476|NCT01847586|Procedure|Paired Associative Stimulation|PAS simulates in humans the induction of long-term potentiation (LTP), a prototype of synaptic neuroplasticity. PAS involves the repetitive pairing of electrical stimulation of the median nerve with - 25 ms later - transcranial magnetic stimulation (TMS) of the contralateral DLPFC. As such, these two stimulations arrive simultaneously in the DLPFC and result in potentiation of TMS induced cortical evoked potential, analogous to in vitro LTP.
16141477|NCT01847586|Procedure|Paired Associative Stimulation-Control|PAS-C is a control PAS paradigm in which TMS to the left DLPFC follows the electrical stimulation of the right median nerve by 100 ms, and, thus, does not result in contemporaneous occurrence of the two stimulations in the cortex and consequently no LTP.
16141478|NCT01847573|Drug|HT-100|May be administered in either fed or fasted state
16141479|NCT01847534|Other|Supplemental PN|
16141480|NCT01847534|Other|Standard Care|
16141481|NCT01847521|Dietary Supplement|Luteolin, Quercetin and Rutin combined in a capsule|
16141482|NCT01847508|Device|PHILOS+|Proximal Humerus Internal Locking System with screw tip augmentation (PHILOS+) with high viscous polymethylmethacrylate (PMMA) cement (Traumacem V+).
16141483|NCT01847508|Device|PHILOS|Proximal Humerus Internal Locking System (PHILOS).
16141484|NCT01847495|Drug|Irinotecan|40mg/m2 x 3-5 days
16141485|NCT01847495|Radiation|CyberKnife|45-60 Gy for 3-5 days CyberKnife SBRT to liver metastasis within 10 elapsed days. Irinotecan will be administered on the same day, prior to SBRT.
16141486|NCT01847482|Device|ZOLL Intravascular Temperature Management System (IVTM)|Induced therapeutic hypothermia post cardiac arrest
16141487|NCT01847469|Behavioral|Enhanced-Cognitive Processing Therapy-C (E-CPT-C)|
16141488|NCT01847469|Drug|Zonisamide|
16141489|NCT01847469|Drug|Placebo|
16141490|NCT01847456|Drug|human insulin as nasal spray|
16141491|NCT01847456|Drug|Placebo|
16141492|NCT01847443|Drug|Nicotine (2 mg)|2 mg nicotine gum in two formulations
16141493|NCT01847443|Drug|Nicotine (4 mg)|4 mg nicotine gum in two formulations
16141494|NCT01847430|Biological|Engerix™-B Kinder|Single dose administered intramuscularly in the deltoid region of non-dominant arm at Day 0.
16141495|NCT01847417|Drug|Test 1= ASA 100 mg and pantoprazole 20 mg capsule formulation one|Formulation Test 1 of a fixed dose combination capsule of ASA and pantoprazole (Each capsule contains ASA 100 mg and pantoprazole 20 mg) manufactured by Piramal Healthcare Limited, India for GSK
16141496|NCT01847417|Drug|Test 2= ASA 100 mg and pantoprazole 20 mg capsule formulation two|Formulation Test 2 of a fixed dose combination capsule of ASA and pantoprazole (Each capsule contains ASA 100 mg and pantoprazole 20 mg) manufactured by Piramal Healthcare Limited, India for GSK
16141497|NCT01847417|Drug|ASA 100 mg tablet|Aspirin® Protect 100 mg tablets (Each tablet contains ASA 100 mg) manufactured by Bayer vital GmbH, 51368 Leverkusen, Germany
16141498|NCT01847417|Drug|Pantoprazole 20 mg gastro-resistant tablet|Protium® 20 mg gastro-resistant tablets (Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate)) marketing authorisation holder Nycomed GmbH, Byk-Gulden-Straβe 2, D-78467, Konstanz, Germany
16141499|NCT01847404|Drug|Test 1= ASA 100 mg and pantoprazole 20 mg capsule formulation one|Formulation Test 1 of a fixed dose combination capsule of ASA and pantoprazole (Each capsule contains ASA 100 mg and pantoprazole 20 mg) manufactured by Piramal Healthcare Limited, India for GSK
16141500|NCT01847404|Drug|Test 2= ASA 100 mg and pantoprazole 20 mg capsule formulation two|Formulation Test 2 of a fixed dose combination capsule of ASA and pantoprazole (Each capsule contains ASA 100 mg and pantoprazole 20 mg) manufactured by Piramal Healthcare Limited, India for GSK
16141501|NCT01847404|Drug|ASA 100 mg tablet|Aspirin® Protect 100 mg tablets (Each tablet contains ASA 100 mg) manufactured by Bayer vital GmbH, 51368 Leverkusen, Germany
16141502|NCT01847404|Drug|Pantoprazole 20 mg gastro-resistant tablet|Protium® 20 mg gastro-resistant tablets (Each gastro-resistant tablet contains 20 mg of pantoprazole (as sodium sesquihydrate)) marketing authorisation holder Nycomed GmbH, Byk-Gulden-Straβe 2, D-78467, Konstanz, Germany
16141503|NCT01847391|Drug|GS-6615|GS-6615 tablet(s) administered orally once daily
16141504|NCT01847391|Drug|Placebo|Placebo tablet(s) to match GS-6615 administered orally once daily
16141505|NCT01847378|Procedure|Catheter ablation|During mapping and ablation tissue voltage and impedance will be stored and analyzed thereafter. The same procedure will be done in regard to activating maps.
16141506|NCT01847365|Device|Transcorneal electrical stimulation|Transcorneal electrical stimulation will be delivered by the CE-marked Okustim device.
16141507|NCT01847352|Drug|Intravenous administration of ferric carboxymaltose|Intravenous administration of ferric carboxymaltose 15mg/kg up to a maximum dose of 1000mg
16141508|NCT01847352|Other|Subacute hypoxic exposures|Exposure to six hours of isocapnic hypoxia with end-tidal partial pressure of oxygen clamped at 55 Torr, with and without prior iron infusion
16141509|NCT01847339|Drug|bupivacaine|In study group a 1 square centimeter piece of absorbable gelatin sponge will be soaked in the bupivacaine solution %0.25 and then will be placed by the surgeon in the epidural space before final closure.
16141510|NCT01847339|Other|saline solution|In study group a 1 square centimeter piece of absorbable gelatin sponge will be soaked in the saline solution and then will be placed by the surgeon in the epidural space before final closure
16141511|NCT01847326|Drug|carboplatin|Given IV
16141512|NCT01847326|Drug|paclitaxel albumin-stabilized nanoparticle formulation|Given IV
16141513|NCT01847326|Drug|fluorouracil|Given IV
16141514|NCT01847326|Drug|hydroxyurea|Given PO
16141515|NCT01847326|Procedure|therapeutic conventional surgery|Undergo surgical resection
16141516|NCT01847326|Radiation|radiation therapy|Undergo radiation therapy
16141517|NCT01847326|Radiation|hyperfractionated radiation therapy|Undergo hyperfractionated radiation therapy
16141518|NCT01847326|Other|laboratory biomarker analysis|Correlative studies
16141519|NCT01847313|Drug|Liraglutide|Daily administration of liraglutide for 6 months
16141520|NCT01847300|Behavioral|cSBI-M|In cSBI-M participants complete a computerized screen for alcohol and tobacco use and then view 10 pages describing the health effects of substance use and true life stories of those affected by substance use.
16141523|NCT01847261|Dietary Supplement|Soy Dairy Protein Blend|
16141524|NCT01847261|Dietary Supplement|Positive Control (Dairy Whey Protein)|
16141525|NCT01847235|Drug|Temozolomide|Temozolomide 200 mg/m2/d in a fasting state for 5 consecutive days (1,000 mg/m2 per 28-day cycle).
16141526|NCT01847222|Biological|SANGUINATE™|PEG-bHb-CO
16141527|NCT01847222|Drug|Normal Saline Solution|Placebo
16141528|NCT01847209|Procedure|Video-Assisted Thoracic Surgery (VATS) wedge resection|
16141529|NCT01847196|Device|Angel® Catheter|The Angel® Catheter combines the functions of an inferior vena cava (IVC) filter and a multi-lumen central venous catheter (CVC). The device is designed to be placed in the inferior vena cava, via the femoral vein, for the prevention of Pulmonary Embolism (PE), and for access to the central venous system. The device is intended for short-term use (less than 30 days) and must be removed before hospital discharge.
16141530|NCT01847183|Behavioral|Click City®: Alcohol|A school based program, Click City®: Alcohol consists of 12 effective components delivered in 7th grade and a booster of 5 effective components delivered in 8th grade.
16141531|NCT01847170|Biological|Fecal Microbial Transplantation|
16141532|NCT01847157|Device|tDCS|"Intelect mobile combination (Intelect, USA) is utilized as a direct current stimulator. The 25 cm2 electrodes on a sponge slice immersed in physiological salt solution are fixed on the left and right positions C3/ C4 of subject head (according to the international 10-20 system of electroencephalogram).
~During the treatment, 1.5 mA electric current is applied to stimulate the subjects in the experimental group for totally 30 minutes. At the start and the end of stimulation, the electric current will gradually increase from zero, or reduce to zero in 1 minute in order to avoid the possible appearance of slight flash effect of subject eyesight, which is caused by instantly turning on or turning off the electric current."
16141533|NCT01847157|Drug|Epidermis anesthesia|"15 g of Emla 5% Cream(anesthetic) is applied to the ventral surface of the forearm of unaffected side with a distance of 10 mm from the wrist, and an area of 150 mm long x 50 mm wide.
~Furthermore, 10 g Emla 5% Cream(anesthetic) is applied to the ventral surface of the upper arm of affected side with a distance of 10 mm from the wrist, and an area of 100 mm long x 50 mm wide."
16141534|NCT01847157|Drug|sham anesthesia|"15 g of 5% body Cream is applied to the ventral surface of the forearm of unaffected side with a distance of 10 mm from the wrist, and an area of 150 mm long x 50 mm wide.
~10 g body Cream is applied to the ventral surface of the upper arm of affected side with a distance of 10 mm from the wrist, and an area of 100 mm long x 50 mm wide."
16141535|NCT01847157|Other|Repeated passive movement|"Repeated passive wrist extension training: Patients' wrist joint are passively moved by a trained occupational therapist (joint moving angle = 0- 60 degree), frequency 1 Hz, maintain for 20 minutes.
~Finger passive flexion and extension training: Patients' fingers joint are passively moved by a trained occupational therapist, frequency 1 Hz, maintain for 10 minutes."
16141536|NCT01847157|Device|sham tDCS|The equipment of sham stimulation in the control group is exactly the same as the equipment in the experiment group. However, the only difference is that 30 seconds after the start of electric current, the experimenter turns off the powder under subject ignorance situation. The stimulation just gives patients weak sense of electric current, in order to blind them for which group they are in.
16141537|NCT01847144|Drug|Gliclazide 80mg OD|Gliclazide 80mg OD (DPP-IV inhibitor) - for 4 weeks duration followed by a 2 week wash-out period.
16141538|NCT01847144|Drug|Sitagliptin 100mg OD|Sitagliptin 100mg OD (sulphonylurea)- for 4 weeks duration followed by a 2 week wash-out period.
16141539|NCT01847131|Drug|oxymetazoline|0.05% Oxymetazoline nasal sprays were commercially available.
16141540|NCT01847131|Drug|Placebo nasal spray|Placebo nasal spray has made by the local pharmaceutical company in thailand who commercially manufacture and sell 0.05% oxymetazoline nasal spray. The placebo contains the same ingredients as the drug except the active ingredient.
16141541|NCT01847118|Drug|Sevacizumab|
16141542|NCT01847105|Other|RevitaLens|Multi-purpose disinfecting solution
16141543|NCT01847105|Other|OptiFree PureMoist|Multi-purpose disinfecting solution
16141544|NCT01847092|Drug|AZD1722|
16141545|NCT01847092|Drug|Placebo|Placebo for AZD1722
16141546|NCT01847079|Other|Procalcitonin|Procalcitonin to guide obtaining bloodcultures
16141547|NCT01847066|Device|Erbium 2940 plus cosmetics plus Impact|Laser used in all arms
16141548|NCT01847066|Device|Erbium 2940 plus cosmetics|laser
16141549|NCT01847053|Other|cinnamon|Intervention will be both ground cinnamon and cinnamon extract.
16141550|NCT01847053|Other|Oatmeal|Oatmeal control, around 70g; without cinnamon
16141551|NCT01847027|Drug|NutraStem|"Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress.
~Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress."
16141552|NCT01847027|Drug|Placebo|Determine whether NutraStem® in combination with an exercise stimulus will cause increased human peripheral blood sample levels of CD34+ and CD133+ adult stem cells and whether these stem cells display more protection against oxidative stress.
16141553|NCT01847014|Drug|Macitentan|Macitentan tablet, dose of 10 mg, once daily.
16141554|NCT01847001|Drug|Propranolol|Propranolol starting dose is 20mg b.i.d.; propranolol dose is up-titrated to 40mg b.i.d. to 80 mg daily with chemotherapy depending on tolerability. Tolerability is assessed every 2 weeks.
16141555|NCT01847001|Other|DOT imaging|(Non-experimental) During the baseline visit, you will undergo DOT evaluation of your tumor for determination of blood, fat, and water content in the affected and unaffected breast. DOT readings will be obtained at 4 additional time points: after paclitaxel week #3, before AC week #1, before AC week #3, and prior to surgery.
16141556|NCT01847001|Drug|Paclitaxel|(Non-experimental) given as a one-hour intravenous infusion (IV) every week for a total of 12 weeks; the first dose of paclitaxel may be given over 90 minutes, per the discretion of your treating doctor. The dose will be given in 80 mg/m2 based on individual body surface area (BSA). This drug is given through a vein in the arm or a catheter (eg. Infusaport, Portacath).
16141557|NCT01847001|Drug|Nab-paclitaxel|(Non-experimental) In the event paclitaxel is not available due to manufacturing and supply shortages, nab-paclitaxel will be substituted for paclitaxel. The dose is 100 mg/m2 IV infusion over 30 minutes weekly (or institutional standard). No premedications are given with nab-paclitaxel.
16141558|NCT01847001|Drug|Trastuzumab|(Non-experimental) (only if HER2-positive): Trastuzumab is given as an IV infusion initially over 90 minutes for the first dose, then 30-60 minutes every 3 weeks in subsequent doses if well tolerated. To be given every 3 weeks with paclitaxel/propranolol.
16141559|NCT01847001|Drug|Pertuzumab|(Non-experimental) (only if HER2-positive): Pertuzumab is given as an IV infusion over 60 minutes on the first dose, then 30-60 minutes every 3 weeks if well tolerated. To be given every 3 weeks with paclitaxel/propranolol.
16141560|NCT01847001|Drug|Doxorubicin|(Non-experimental) Doxorubicin will be given as a 510 minute intravenous infusion (IV) in a dose of 60 mg/m2; cyclophosphamide will be given as a 3060 minutes intravenous infusion (IV) in a dose of 600 mg/m2 based on BSA. This chemotherapy regimen will be given every 2 weeks for total of 8 weeks or 2 months.
16141561|NCT01847001|Drug|Cyclophosphamide|(Non-experimental) Doxorubicin 60 mg/m2 IV over 5-10 minutes, Cyclophosphamide 600 mg/m2 IV infusion over 30-60 minutes. The first cycle should be initiated with 3 weeks after the last paclitaxel and/or trastuzumab/pertuzumab dose.
16141562|NCT01847001|Procedure|Surgery|After you complete all chemotherapy plus propranolol treatment, you will then have surgery to remove the breast tumor if your doctor feels that it is medically appropriate (if you have had a good response to the treatment) - lumpectomy/mastectomy.
16141563|NCT01847001|Drug|Premedication|As premedication to prevent some of the side effects associated with paclitaxel, you will also receive dexamethasone (Decadron) in a dose of 10 mg, diphenhydramine (Benadryl) in doses of 2550 mg, and an H2 blocker (eg. ranitidine 50 mg or equivalent) 3060 minutes before each paclitaxel infusion. If no hypersensitivity reactions are experienced, dexamethasone may be reduced in increments of 2 mg per week per dose (until a minimum of 2 mg has been reached).
16141564|NCT01847001|Drug|Anti-nausea therapy|In addition to doxorubicin, you will receive an anti-nausea therapy and dexamethasone about 3060 minutes before AC chemotherapy.
16141565|NCT01847001|Drug|Pegfilgrastim|When you receive the AC chemotherapy, you will also receive treatment with a drug called pegfilgrastim (Neulasta). Neulasta is a commercially available drug. It stimulates the production of white blood cells and reduces the likelihood of developing a low white blood cell count and fever after chemotherapy. It will be given as an injection under the skin on the day after each chemotherapy treatment (day 2).
16141566|NCT01846988|Device|crossover treatment (REMstar Auto A-Flex)|All subjects will use same device with 4 week crossover of settings of APAP and CPAP
16141567|NCT01846975|Drug|IV Abatacept|Transition from weekly SC- to a single IV-Abatacept but also the return to weekly SC treatments after a 4 week break.
16141568|NCT01846962|Drug|Budesonide|The administered dose of topical steroid was 400mcg or 800mcg/day (<150 cm or >150 cm). Patients were trained to swallow puffs and to non eat or drink fo 30 minutes after ingestion. Patients noncompliant with therapy, monthly assessed by Pediatric Allergologists, were withdrawn from the study.
16141569|NCT01846962|Drug|Fluticasone|The administered dose of topical steroid was 440mcg or 880mcg/day (<150 cm or >150 cm). Patients were trained to swallow puffs and to non eat or drink fo 30 minutes after ingestion. Patients noncompliant with therapy, monthly assessed by Pediatric Allergologists, were withdrawn from the study.
16141570|NCT01846962|Behavioral|six-foods elimination diet|six-foods elimination diet. The standard panel of foods tested included the 6 most common allergenic foods in childhood (cow's milk, egg, soy, wheat, peanuts, fish), plus foods that were suspiciously implicated in triggering an allergic reaction referred by patients or their parents. Both perennial (dust mite, Parietaria, Alternaria, cat and dog dander) and seasonal (grass pollen including Graminaceae, Olea europea, Platanus) aeroallergens have been tested.
16141571|NCT01846962|Drug|Oral Viscous Budesonide (OVB)|The administered dose of topical steroid was 1mg/day or 2mg/day (<150 cm or >150 cm). Patients were trained to prepare a homemade suspension of OVB prepared by mixing inhaled budesonide with viscous solutions of sodium alginate and to non eat or drink fo 30 minutes after ingestion. Patients noncompliant with therapy, monthly assessed by Pediatric Allergologists, were withdrawn from the study.
16141572|NCT01846936|Procedure|DLT with conventional technique|The double lumen tube is introduced into the glottis under direct laryngoscopy. After the bronchial cuff had passes the vocal cords, the tube is rotated counterclockwise 90° and advanced until a slight resistance was encountered.
16141573|NCT01846936|Procedure|BB with conventional technique|"The brochial blocker (BB) is introduced through the endotracheal tube to the desired bronchus under FOB vision by turning the device's steering wheel.
~The BB cuff is inflated with air under FOB vision with the volume necessary to seal the bronchus and initiate one lung ventilation."
16141574|NCT01846936|Procedure|Disconnection technique|Disconnection technique 1) deflate of the blocker cuff, 2) turn-off the ventilator and opened the APL valve allowing both lungs to collapse, 3) after loss of carbon dioxide trace in the capnograph, reinflate blocker cuff with the same volume of air as during the initial insertion, 4) reconnect the tube to the ventilator allowing only dependent-lung reventilation with a 5 cmH2O positive end-expiratory pressure preceded by a single recruitment maneuver performed by elevating the airway pressure to 40 cmH2O for 7 seconds.
16141575|NCT01846923|Biological|PCV13|
16141615|NCT01846520|Other|questionnaire administration|Ancillary studies
16141616|NCT01846507|Drug|Tranexamic Acid|Subjects will be instructed to take 2 tablets (1300) mg of Lysteda three times daily (3900 mg/daily) for five days during monthly menstruation.
16141617|NCT01846481|Drug|RBP-8000 100 mg|RBP-8000 100 mg administered in the vein on either study day 3 or 6. There is a 72-hour washout between Days 3 and 6
16142116|NCT01842672|Drug|Clofarabine|Dose Escalation of Clofarabine
16141576|NCT01846910|Behavioral|Tooth Whitening|1. A dental check-up will ensure the absence of contraindications to tooth whitening (cavities, soft tissue pathology, severe periodontitis) 2. Removal of calculus, plaque, or stains with a dental polishing 3. Treatment time is approximately 1 hour total4. Lips are retracted, tongue protector is placed and protective eyewear used 5. Saliva is suctioned and teeth are air dried 6. A liquid rubber dam material is applied to protect gums and cured by visible light. 7. The bleaching material is placed on the enamel surface of the involved teeth and is replaced if drying occurs 8. After 15 minutes, the bleach is suctioned, mouth rinsed and process repeated 9. Three to four applications are typically used
16141577|NCT01846910|Behavioral|Motivational Counseling|Normally three counseling sessions. Session #1: Introductions; discuss habits, feelings, pros and cons of smoking; degree of addiction; previous quit attempts and relapse; reinforce patient confidence; open-ended questions to illicit self-efficacy; homework includes Pack-Track and Why Test. Session #2: Discuss smoking patterns, triggers, and risk situations; discuss methods to resist triggers, need for medications; prepare environment and back-up plan; discuss quit date; homework to review self-help workbook. Session #3: Reinforce previous concepts; review resistance plan; discuss and arrange pharmaceutical cessation aids; set quit date; homework to finalize all self/home preparations; offer tooth polishing on quit date; follow-up by telephone or appointment.
16141578|NCT01846871|Drug|Tivozanib|
16141579|NCT01846845|Device|Conventional Prosthetic Transfemoral Socket System|Conventional transfemoral may include an ischial containment socket, a pin suspension socket, and/or suction suspension socket
16141580|NCT01846845|Device|Novel Prosthetic transfemoral socket system|Prosthetic socket that incorporates lower socket trim-lines and transfemoral vacuum suspension
16141581|NCT01846832|Drug|TMC435|150 mg taken orally (by mouth) as a capsule with food once daily for 12 weeks.
16141582|NCT01846832|Drug|Pegylated interferon alfa-2a (PegIFNα-2a)|180 mcg administered according to the manufacturer's prescribing information as a 0.5 mL subcutaneous (under the skin) (SC) injection once a week in the morning or evening for up to 24 weeks.
16141583|NCT01846832|Drug|Ribavirin (RBV)|1000 mg or 1200 mg administered according to the manufacturer's prescribing information for up to 24 weeks. If the participant's baseline body weight is < 75 kg, the total daily dose of RBV will be 1000 mg, administered orally (by mouth) as 400 mg (2 tablets of 200 mg, intake with food) in the morning and 600 mg (3 tablets of 200 mg, intake with food) in the evening. If the baseline body weight is > or = 75 kg, the total daily dose will be 1200 mg, administered as 600 mg in the morning and evening (3 tablets of 200 mg per intake, with food).
16141584|NCT01846806|Other|Rifaximin|Participants in Phase B will be administered 550 mg of Rifaximin two times a day for 14 days.
16141585|NCT01846793|Drug|NX-1207|2.5 mg NX-1207 in 10 mL saline vehicle
16141586|NCT01846780|Procedure|PTA & stenting|PTA & stenting of the iliac veins and/or common femoral vein. Patients who need to undergo endophlebectomy of the common femoral vein with AV-fistula creation are also included.
16141587|NCT01846767|Other|Oral glucose breath test|Simultaneous oral glucose tolerance test and exogenous 13C-glucose breath test following a 12hr overnight fast. Fasting samples were obtained for plasma glucose, insulin, c-peptide, leptin, adiponectin, resistin, HbA1c and two breath 13CO2 abundance values (at t = -15 and -5min). At t = 0min, each subject drank a 75g glucose solution (Thornton & Ross, UK) containing 0.15g of 1-13C glucose. Further breath samples (every 15 min over a 240min interval) and further plasma blood glucose, insulin and c-peptide samples (90,120,180min) were also taken.
16141588|NCT01846741|Device|M106 VNS Therapy System|
16141589|NCT01846728|Drug|Estrogen suppression|Estrogen production will be suppressed for 3 months by administering a drug, lupron, that suppresses ovarian function
16141590|NCT01846715|Biological|Implantation of SRC|
16141591|NCT01846702|Drug|Placebo|Given as a SC injection.
16141592|NCT01846702|Drug|LY3084077|Given as a SC injection.
16141593|NCT01846689|Drug|ESS (medical food/drug)|Prescription medical food erythropoietin stimulating system
16141594|NCT01846676|Behavioral|Active Communication Education Program|The program called Active Communication Education (ACE), that is a semistructured rehabilitation program for people with hearing loss, which aims to improve rehabilitation of hearing aids users by a strategy based on problem solution.
16141595|NCT01846676|Other|Control|Participants in this arm will not receive intervention during the study protocol time. After the completion of the protocol, they will receive the same intervention that the intervention group, meaning the ACE program intervention.
16141596|NCT01846663|Drug|Placebo|Placebo, oral, 0 mg BID, 6 months of treatment
16141597|NCT01846663|Drug|Rifaximin|Rifaximin, oral, 550 mg BID, 6 months treatment
16141598|NCT01846650|Drug|Capecitabine tablets|Single oral Capecitabine tablets 2000mg qd
16141599|NCT01846650|Drug|XELODA|Single oral XELODA 2000mg qd
16141600|NCT01846637|Procedure|laparoscopic sleeve gastrectomy|
16141601|NCT01846624|Drug|Decitabine|Given IV
16141602|NCT01846624|Drug|Midostaurin|Given PO
16141603|NCT01846611|Drug|Trabectedin|1.1 mg/m^2 administered intravenously over approximately 3 hours on Day 1 of each 21-day treatment cycle.
16141604|NCT01846611|Drug|DOXIL|30 mg/m^2 administered intravenously over approximately 90 minutes on Day 1 of each 21-day treatment cycle.
16141605|NCT01846611|Drug|Dexamethasone|20 mg administered intravenously on Day 1 of each 21-day treatment cycle approximately 30 minutes prior to study drug infusion.
16141606|NCT01846611|Drug|DOXIL|50 mg/m^2 administered intravenously over approximately 90 minutes on Day 1 of each 28-day treatment cycle.
16141607|NCT01846585|Behavioral|Arousal Based Therapy for Insomnia|Intervention includes education about sleep and a desensitization technique to reduce sleep interfering arousal
16141608|NCT01846585|Behavioral|Cognitive Behavioral Therapy for Insomnia|Intervention includes education about sleep and behavioral and cognitive strategies to improve sleep
16141609|NCT01846559|Biological|Endotoxin|E.coli Endotoxin Day 7 - 2 ng/kg
16141610|NCT01846559|Drug|Clopidogrel|Clopidogrel (tablet) over 8 days Day 1: 300 mg loading dose Day 2-7: 75 mg orally once daily
16141611|NCT01846559|Drug|Ticagrelor|Ticagrelor over 8 days (tablet) Day 1: 180 mg loading dose Day 2-7: 90 mg orally twice daily
16141612|NCT01846520|Other|educational intervention|Receive FCPCI home education sessions
16141613|NCT01846520|Behavioral|telephone-based intervention|Receive FCPCI telephone support sessions and 24 hour telephone support
16142117|NCT01842672|Drug|Mitoxantrone|
16141618|NCT01846481|Drug|Placebo|IV infusion of Placebo administered 1 minute after cocaine infusion on either day 3 or 6.
16141619|NCT01846481|Drug|Cocaine|50 mg intravenous (IV) dose of cocaine administered over 10 minutes on Days 1, 3 and 6.
16141620|NCT01846481|Drug|RBP-8000 200 mg|RBP-8000 200 mg administered in the vein on either study day 3 or 6. There is a 72-hour washout between Days 3 and 6
16141621|NCT01846468|Drug|LHW090|1 mg, 12.5 mg, 100 mg capsules
16141622|NCT01846468|Drug|Placebo|Matching placebo capsules
16141623|NCT01846455|Drug|2.0mg Buprenorphine/0.5mg Naloxone|Each participant received a single sublingual dose of Suboxone® on Day 1 following a fast of at least 8 hours prior to dosing and 2 hours after dosing.
16141624|NCT01846455|Drug|Promethazine|Each participant received a 25-mg or 50-mg promethazine oral dose 30 minutes before Suboxone® administration and then 25-mg promethazine orally or by rectal suppositories every 4 hours as needed for nausea and vomiting during the first 48 hours after Suboxone® administration.
16141625|NCT01846442|Drug|Placebo|Placebo vaginal suppository containing 0.0% (0 mg) DHEA; daily dosing with one suppository for 12 weeks.
16141626|NCT01846442|Drug|DHEA (0.25%)|Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
16141627|NCT01846442|Drug|DHEA (0.5%)|Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
16141628|NCT01846442|Drug|DHEA (1.0%)|Vaginal suppository containing 1.0% (13 mg) DHEA; daily dosing with one suppository for 12 weeks.
16141629|NCT01846429|Drug|Sodium Bicarbonate|Cohort 1 patients will take 10 capsules/day; cohort 2 patients will take 20 capsules/day; cohort 3 patients will take 30 capsules/day and cohort 4 patients will take 40 capsules/day. Cohort 2 - 4 patients will begin at the cohort 1 dose and dose escalate to their respective cohort doses in order to prevent any side effects associated with alkalosis. Dose escalation will occur at a rate of 10 capsules/week.
16141630|NCT01846416|Drug|Atezolizumab (MPDL3280A) [TECENTRIQ], an engineered anti-PDL1 antibody|Atezolizumab 1200 mg IV on Day 1 of each 21-day cycle until disease progression.
16141631|NCT01846403|Device|Semi-quantitative urine pregnancy test|
16141632|NCT01846390|Drug|Gemcitabine|Group 1 = 1000 mg/m2 D1, D8. Subsequent dose levels according to toxicity = 600-1000 mg/m2 D1, D15.
16141633|NCT01846390|Drug|Dexamethasone|40 mg D1 - D4
16141634|NCT01846390|Drug|Cisplatin|75 mg/m2 D1
16141635|NCT01846390|Drug|Romidepsin|Dose Level 0 - 6 mg/m2 D1, D8. Subsequent dose levels according to toxicity 6-14 mg/m2 D1, D15.
16141636|NCT01846377|Behavioral|G4H-Diab-Nano|The Diab and Nanoswarm games present fun, challenging: knowledge mini-games enabling children to learn desired behavior changes; goal-setting tailored to child's current behaviors and preferences to make lifestyle changes; problem solving to enable children to find strategies to overcome behavior change barriers; motivational statements tailored to child's values to enhance their desire to make the goal related lifestyle changes; and energy balance games to enable them to balance food portions with physical activities. Each game has 9 sessions each with approximately 45-60 min of game-play. At the end of each session, goals are set. The child is allowed to re-play non-behavior change mini-games, and view video segments, but not redo their goal setting or behavior change mini-games.
16141637|NCT01846364|Dietary Supplement|Diindolylmethane (DIM)|300 mg of Bioresponse DIM (100mg/day of active DIM) a day for 30 days
16141638|NCT01846338|Dietary Supplement|green tea extract EGCG|EGCG, 500mg, tid, 4 weeks
16141639|NCT01846325|Dietary Supplement|vitamin E|
16141640|NCT01846325|Dietary Supplement|DHA|
16141641|NCT01846325|Other|placebo|
16141642|NCT01846312|Other|No treatment given|The participants will not receive any treatment.
16141643|NCT01846299|Other|Sham control|The sham vial did not contain active drug (empty sterile vial). The sham injection was an imitation of an intravitreal injection using an injection syringe without a needle touching the eye.
16141644|NCT01846299|Drug|Ranibizumab|Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant.
16141645|NCT01846286|Behavioral|Questionnaires|Five questionnaires about pain and symptoms, each taking approximately 25 - 50 minutes to complete
16141646|NCT01846286|Other|Quantitative Sensory Testing|Tests measure sensitivity to touch, coolness, warmth, hot/cold feeling, and pin pricks. The sensory tests will take about 30 minutes to 1 hour to complete.
16141647|NCT01846273|Drug|Ranibizumab|Intravitreal injection of 0.5 mg ranibizumab
16141648|NCT01846273|Drug|Verteporfin PDT|Infusion of 30 ml verteporfin in 5% dextrose solution followed by 83 sec of laser light (50J/cm2; 600mW/cm2; 689 nm)
16141649|NCT01846273|Drug|Sham PDT|Infusion of 30 ml 5% dextrose solution followed by 83 sec of laser light (50J/cm2; 600mW/cm2; 689 nm)
16141650|NCT01846247|Other|Standard Care + VEM|Patient will receive standard stroke unit care with earlier and additional physiotherapy and nursing sessions as per an intervention protocol.
16141651|NCT01846247|Other|Standard care|
16141652|NCT01846221|Drug|Clonidine|Subjects randomized to clonidine will receive a mixture of 100 micrograms clonidine and 12.5 mg bupivacaine 10 ml of volume.
16141653|NCT01846221|Drug|Fentanyl|Subjects randomized to fentanyl will receive 100 mcg fentanyl and 12.5 mg bupivacaine in 10 ml of volume.
16141654|NCT01846208|Drug|Egg Oral Immunotherapy|Commercially available egg white solid dispensed by the central manufacturer. Study product will be dispensed in vials for low doses, capsules for mid-range doses, and bulk powder with dosing scoops for the higher doses.
16141655|NCT01846208|Drug|Baked Egg|Predetermined food substances with known amounts of Baked Egg (egg protein) with standardized dosing/consumption instructions.
16141656|NCT01846195|Device|CM 1500|
16141657|NCT01846182|Drug|Duloxetine|serotonin norepinephrine reuptake inhibitor
16141658|NCT01846182|Drug|Pregabalin|alpha-2-alpha subunit calcium channel ligand
16141659|NCT01846182|Drug|Placebo|Placebo
16141660|NCT01846169|Behavioral|Food deliveries|Frequency of food deliveries is based on level of food insecurity at baseline (i.e., more food insecurity receives more frequent food deliveries). Deliveries are tailored to the diet of the client (e.g., consist of soft foods if participant has trouble chewing; has more fruits and vegetables if that was a food category the participant at less of at baseline). The brief nutrition education is a review of basic nutrition concepts and healthy eating ideas.
16141741|NCT01845493|Dietary Supplement|Sulforaphane Homogenate|Active
16141986|NCT01843686|Device|Magellan®|Autologous Platelet Rich Plasma Prepared Using the Magellan System
16141661|NCT01846156|Drug|MgSO4|A randomized controlled study that compare three regimens for administration of MgSO4 used for the cases of severe pre-eclampsia that will be performed in the Obstetrics & Gynecology Department, Kasr Al-Ainy Hospital, Cairo University
16141662|NCT01846143|Biological|pBCAR3-phosphopeptide|
16141663|NCT01846143|Biological|pIRS2-phosphopeptide|
16141664|NCT01846143|Biological|2-MpP (pBCAR3-phosphopeptide + pIRS2-phosphopeptide)|
16141665|NCT01846130|Dietary Supplement|Leucine|
16141666|NCT01846130|Behavioral|Exercise|
16141667|NCT01846130|Dietary Supplement|Whey protein|
16141668|NCT01846117|Dietary Supplement|secoisolariciresinol diglucoside, vitamin D|SDG supplementation as a packet of 1.6g/day of BeneFlax containing 600 mg SDG for 24 weeks Vitamin D Natural Product Number (NPN) 80003663 WN Pharmaceuticals Natural Factors Whey Factors
16141669|NCT01846104|Biological|50-μg booster dose RVEc|Subjects will be recruited from the 10 subjects who received three 50-μg doses of RVEc during the Phase 1 trial. Subjects will receive a single booster dose only and will be followed for 6 months after vaccination.
16141670|NCT01846091|Other|Laboratory Biomarker Analysis|Correlative studies
16141671|NCT01846091|Biological|Oncolytic Measles Virus Encoding Thyroidal Sodium Iodide Symporter|Given IT
16141672|NCT01846078|Device|optical biometric measurement (IOLMaster)|IOLMaster version 5.4 was used to measure the patients' optical biometry by non contact technique.
16141673|NCT01846039|Device|Crosslinked hyaluronic acid gel|Up to 3 mL administered by intradermal injection
16141674|NCT01846026|Drug|Vitamin D|compare how vitamin D influences the course of ulcerative colitis versus placebo
16141675|NCT01846026|Drug|placebo|
16141676|NCT01846013|Behavioral|Stand|Stand at least half of the workday at work.
16141677|NCT01846013|Behavioral|Move|Increase movement time at work. Move more by making small changes (walking meetings, take stairs, etc).
16141678|NCT01846013|Behavioral|Stand and Move|Increase standing time to half of workday (4h) and increase movement time at work.
16141679|NCT01846000|Procedure|low-level laser treatment|A gallium-aluminum-arsenide laser will be employed for the LLLT and placebo treatment. The device will be calibrated with a wavelength of 780 nm, energy density of 25 J/cm2, power of 50 mW and power density of 1.25 W/cm2. Exposure time will be 20 seconds per point, resulting in a total energy of 1 J per point. The spot application method will be used in contact with the skin and with a conventional tip, covering an area of 0.04 cm2.
16141680|NCT01845987|Drug|Placebo|Placebo, as two 1-ml subcutaneous (SC) injections, at Week 0 and Week 4
16141681|NCT01845987|Drug|CNTO 1959|CNTO 1959 200 mg, as two 1-ml subcutaneous (SC) injections, at Week 0 and Week 4
16141682|NCT01845974|Device|ThermoCool® SF NAV Catheter|The experimental group will receive the low flow catheter (ThermoCool® SF NAV Catheter) All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.
16141683|NCT01845974|Device|ThermoCool® catheter|The control group will receive the higher flow catheter (ThermoCool® catheter). All data will be collected pre and post procedure therefore patients will act as their own control within each therapeutic group.
16141684|NCT01845948|Behavioral|parental training programme|In the experimental group, parents participated in the parental training programme approximately one month before the start of the academic year in primary school. Two social workers, who have minimum five- year experience in giving family counselling,implemented the interventions.
16141685|NCT01845948|Behavioral|Placebo Control|Parents had no intervention except that an information leaflet for parents on helping children to adapt the new primary school life published by Education Bureau was given to each parent in the control group at the end of data collection.
16141686|NCT01845935|Device|Percutaneous Image-guided Cryoablation (FPRPR3508 IceRod® PLUS Needles)|Treatment consists of a percutaneous cryoablation performed under anesthesia and imaging control.
16141687|NCT01845922|Dietary Supplement|Low sodium diet|Low sodium diet
16141688|NCT01845909|Other|ECG and survey screening|
16141689|NCT01845896|Behavioral|Training|
16141690|NCT01845883|Procedure|Deep Brain Stimulation (DBS)|Patients with DBS will participate to the study both when the stimulation is off and on.
16141691|NCT01845857|Behavioral|Chronic Disease Self-Management Workshop|6 week, small group self-management workshop
16141692|NCT01845844|Drug|Ranibizumab 0.3mg/0.05cc|"Group A (Arm A) will receive monthly 0.3mg/0.05cc intravitreal injections for 12 consecutive months.
~Group B (Arm B) will receive monthly 0.3mg/0.05cc intravitreal injections for the first six months and then PRN for the remaining 6 months per protocol specified criteria."
16141693|NCT01845831|Drug|Sitagliptin|Sitagliptin will be taken orally at 100 mg or 50 mg once a day per renal function.
16141694|NCT01845831|Drug|Basal Bolus|Basal bolus regimen with glargine once daily and rapid-acting insulin (lispro or aspart) before meals + + correction doses of rapid acting insulin if needed
16141695|NCT01845831|Drug|Metformin and Sitagliptin|Janumet is a combination of metformin and sitagliptin. Patients with HbA1c ≤ 7% will be discharged on the combination of metformin and sitagliptin (Janumet ® 500/50 mg) twice daily for 6 months.
16141696|NCT01845831|Drug|Glargine|"Patients with blood glucose between 140-200 mg/dL during hospitalization will receive 0.2 units per kg weight per day.
~Patients with blood glucose between 201-400 mg/dL during hospitalization will receive 0.25 units per kg weight per day."
16141697|NCT01845831|Drug|Glargine 50%|Glargine will be prescribed at 50% of daily hospital dose.
16141698|NCT01845831|Drug|Glargine 80%|Glargine will be prescribed at 80% of daily hospital dose.
16141699|NCT01845805|Drug|oral azacitidine|
16141700|NCT01845805|Other|Observation|
16141701|NCT01845805|Drug|First-line chemotherapy after recurrence|After disease recurrence, subjects on both Arm A and Arm B will start on a first-line chemotherapy (such as abraxane or gemcitabine).
16141702|NCT01845792|Drug|Cabazitaxel with Abiraterone Acetate|Cabazitaxel intravenously every 3 weeks, in combination with abiraterone acetate and prednisone orally daily.
16141703|NCT01845792|Drug|Cabazitaxel|Cabazitaxel intravenously every 3 weeks
16141704|NCT01845779|Drug|DCF regimen|
16141705|NCT01845766|Other|exercise rehabilitation|
16141706|NCT01845753|Other|Observation|Observation
16141742|NCT01845480|Behavioral|Wellness coaching|Wellness coaching that includes modeling, goal setting, self-monitoring, social support, and health behavior education
16141707|NCT01845740|Drug|milatuzumab|Milatuzumab has been used in clinical trials for multiple myeloma, non-Hodgkin's lymphoma and leukemia in the intravenous dosing form. In this study, milatuzumab is being given subcutaneously in patients with lupus.
16141708|NCT01845740|Drug|Placebo|Placebo will be administered subcutaneously once weekly for 4 weeks.
16141709|NCT01845727|Drug|Topical Amphotericin B at 3%|
16141710|NCT01845714|Procedure|Corneal Cross Linking|
16141711|NCT01845714|Procedure|Corneal Cross Linking combined with topoguided PRK|
16141712|NCT01845701|Drug|Artesunate-Amodiaquine|"Pharmacology: Amodiaquine is effective against the erythrocytic stages of all four species of P. falciparum. Amodiaquine accumulates in the parasite's lysosomes and prevents breakdown of haemoglobin on which the parasite depends for its survival.
~Artesunate is a water-soluble hemisuccinate derivative of artemisinin. Artesunate and its active metabolite dihydroartemisinin are potent blood schizonticides, active against the ring stage of the parasite.
~The fixed-dose combination dihydroartemisinin-piperaquine has a cost advantage over other ACTs that brings it within reach of many, making it a potential best candidate for deployment in Africa and other poor countries. The drug is currently produced in China (Duo-cotecxin®)."
16141713|NCT01845701|Drug|Dihydroartemisinine-Piperaquine|It is a bisquinoline antimalarial drug (1,3-bis[1-(7-chloro-4 quinolyl)-4- piperazinyl]-propane) that was first synthesised in the 1960s, and used extensively in China and Indochina as prophylaxis and treatment during the next 20 years. A number of Chinese research groups documented that it was at least as effective as, and better tolerated than, chloroquine against falciparum and vivax malaria. With the development of piperaquine-resistant strains of P. falciparum and the emergence of the artemisinin derivatives, its use declined during the 1980s. However, during the next decade, piperaquine was rediscovered by Chinese scientists as one of a number of compounds suitable for combination with an artemisinin derivative.
16141714|NCT01845701|Drug|Artemether-lumefantrine combination|CoArtem® is an oral, fixed combination of artemether- a derivative of artemisinin and lumefantrine- a novel molecule developed by the Academy of Military Medical Sciences (AMMS) in Beijing. It is the only co-formulated ACT approved by WHO and is currently available through WHO at a negotiated public sector price. Both compounds are effective as single agents. However, recrudescence is common with artemether and lumefantrine has a slow onset of action. A fixed combination tablet (20 mg artemether/120 mg lumefantrine) has therefore been developed. Fixed combination therapy improves compliance and has the advantage of carrying a lower risk of selecting drug resistant strains. No resistance to either component has been observed to date.
16141715|NCT01845688|Drug|Losartan Tablets & QingReMoShen Granule|
16141716|NCT01845688|Drug|Losartan Tablets & Placebo Granule|
16141717|NCT01845675|Drug|temozolomide or dacarbazine-based chemotherapy, endostatin|
16141718|NCT01845662|Other|Surgical or non-surgical management|Retrospective surgical (splenectomy) or non-surgical management (embolization or conservative management)
16141719|NCT01845649|Drug|Estradiol Vaginal Gel|Daily for 14 days followed by 3 times per week for 10 weeks
16141720|NCT01845649|Drug|Vehicle|Daily for 14 days followed by 3 times per week for 10 weeks
16141721|NCT01845636|Drug|Donepezil|Donepezil 5mg will be given for 4 weeks and if tolerated, the dose will be increased to 10 mg per day. The dose range of 5 to 10 mg of donepezil per day will be continued for the study duration, and this is the recommended dose for donepezil in the treatment of mild to moderate Alzheimer's disease.
16141722|NCT01845636|Drug|Atropine|A single acute dose of 1 mg of atropine nasal spray is administered to the nostril. The dose chosen reflects clinical doses typically used by Ear, Nose, and Throat (ENT) physicians.
16141723|NCT01845623|Drug|QAB149 75 mg Concept 1|QAB149 delivered via the concept 1 device.
16141724|NCT01845623|Drug|QAB149 75 mg Epic Test Fixture|QAB149 delivered via the EPIC test fixture
16141725|NCT01845623|Other|Placebo Concept 1|Placebo administered via the Concept 1 device.
16141726|NCT01845623|Other|Placebo EPIC Test Fixture|Placebo administered via the EPIC Test Fixture.
16141727|NCT01845610|Dietary Supplement|Fortified fat-based paste with essential fatty acids, DHA, ARA, phytase, L-lysine, potassium, phosphorous, magnesium and manganese|Complementary food supplement providing micronutrients, essential fatty acids, DHA and ARA, phytase, L-lysine, potassium, phosphorous, magnesium and manganese
16141728|NCT01845610|Dietary Supplement|Fortified fat-based paste with essential fatty acids|Complementary food supplement fortified with micronutrients and essential fatty acids
16141729|NCT01845597|Procedure|MAKOplasty® medial UKA|A robot guided medical Unicompartmental knee arthroplasty (UKA) is a procedure to replace only the medial tibiofemoral compartment of the knee.
16141730|NCT01845584|Drug|NPB-01|
16141731|NCT01845558|Drug|Wobenzym® plus|
16141732|NCT01845558|Other|Placebo|
16141733|NCT01845545|Other|Early provision of microfinance|The CPSL staff will support the formation of the self-help groups from the start of the study. The women in this group will have access to microfinance from the first 18 months of the study and will be eligible for emergency loans (up to Rs3000) and general purpose loans, (Rs50-3000) after 3-6 months of starting the self-help group.
16141734|NCT01845532|Drug|TPI|Trigger point injection with 25G needle on the shoulder before surgery(0.5% procaine, 0.25~0.5% lidocaine, 0.125% bupivacaine)
16141735|NCT01845532|Drug|EMLA cream|EMLA cream with occluding dressing on the shoulder before surgery(5% of eutectic mixture with 2.5% lidocaine and 2.5% prilocaine)
16141736|NCT01845519|Behavioral|Tailored Email|Participants will receive tailored emails.
16141737|NCT01845519|Behavioral|Targeted Email|Participants will receive targeted emails.
16141738|NCT01845506|Device|Cardiorespiratory monitor|Subjects will also be fitted with conventional monitoring devices as per the standard of care (3 or 5 lead ECG, pulse oximeter, blood pressure cuff) and will have vital statistics obtained by a trained research assistant at regular 5-minute intervals including blood pressure, heart rate, temperature, and respiratory rate using the standard cardiorespiratory bedside monitor's cycling protocol. The same parameters will be obtained from the wireless sensor at identical time points for a duration of 2 hours. Data obtained from both conventional and study sources will be entered into an encrypted USB device for later analysis.
16141739|NCT01845506|Device|Wireless pressure sensor|Following informed consent, each subject will be fitted with a wireless sensor attached to a conventional laptop computer. The sensors fit around the participant's chest and work as transducers.
16141740|NCT01845493|Dietary Supplement|Alpha Sprout Homogenate|Alpha Sprout Homogenate
16141743|NCT01845454|Device|trūFreeze™ Spray Cryotherapy|The trūFreeze™ System consists of a console containing a holding tank for medical grade liquid nitrogen and a spray tip CSATM Catheter. The physician uses the console to initiate and control the flow and duration of the cryogen spray. The liquid nitrogen is propelled through a spray CSATM Catheter to the selected site by pressure in the holding tank and freezing techniques are monitored by direct visualization with an endoscope. Once the freezing is completed, the cryogen flow is terminated and the thawing system may be engaged to allow accessory removal. If multiple cycles are used, thawing is initiated at the end of the procedure.
16141744|NCT01845441|Drug|Dexmedetomidine|Precedex will be given to randomized subjects in thi study to evaluate its efficacy in maintaining optimal sedation and preserving neurological exam.
16141745|NCT01845441|Drug|Fentanyl|Patients in the control arm will receive no medication or standard sedative drug for the interventional procedure.
16141746|NCT01845441|Drug|Midazolam|Patients in the control arm will receive no medication or standard sedative drug for the interventional procedure.
16141747|NCT01845428|Drug|Pravastatin|After collecting baseline plasma samples, participants will receive pravastatin 20mg daily. After 6 weeks, we will collect samples and safety data. Subsequent statin therapy will be at the discretion of the treating physician.
16141748|NCT01845415|Behavioral|Social Marketing Campaign|The campaign will involve distribution of posters throughout the communities promoting awareness of the consequences of fall injuries and encouraging people to go to an website that provides safety information and injury stories.
16141749|NCT01845415|Behavioral|Intervention components|Doctors and nurses in these communities will perform health education to parents of 1 through 4 year olds around the risks of falls in the home when these parents visit the doctor for regular visits. Also, several parenting classes in these communities will be modified to include educational videos and discussion of these issues
16141750|NCT01845402|Biological|blood and urine samples|A blood sample and urine sample will be collected for purpose of the study. CKD (Chronic kidney injury) will be diagnosed according to the KDIGO criteria in children.
16141751|NCT01845389|Device|Epidural (B. Braun)|20-gauge epidural catheter threaded cephalad through an 18 gauge needle identified by the loss of resistance method to air.
16141752|NCT01845389|Device|Spinal (Wiley Spinal Catheter)|The Wiley Spinal® is an innovative Flexible Cannula over Needle designed for convenient intrathecal access. After dural puncture is achieved, an immediate dural seal is created. The flexible cannula is advanced off the needle ensuring cephalad delivery of medication.
16141753|NCT01845376|Procedure|local anesthesia group|Patients will receive local anesthesia similar to that described by Amid et al. except that 1% lidocaine with adrenaline (1:200,000) will be used instead of a mixture of lidocaine and bupivacaine.
16141754|NCT01845376|Procedure|spinal anesthesia group|Patients will be positioned in the lateral position and a Whitacre 25 G needle will be inserted at L3-4 intervertebral space and then heavy bupivacaine 0.5% 15 mg will be injected.
16141755|NCT01845376|Procedure|general anesthesia group|Patients will be induced with propofol 2 mg/kg and fentanyl 1.5 µg /kg. They are then allowed to breathe spontaneously with sevoflurane 2% to 2.5% in a mixture of 60% oxygen through a laryngeal mask. End-tidal concentration of sevoflurane will be adjusted to keep end-tidal sevoflurane 1MAC. Supplemental doses of 25 µg of fentanyl will be administered if intraoperative heart rate and blood pressure are greater than 20% of baseline.
16141756|NCT01845363|Drug|Cefazolin used in antimicrobial prophylaxis|"Cefazolin administered a first dose of 2g in anesthetic induction, followed by continuous dosage of 1g diluted in 250mL of saline solution for two hours.
~Two samples of subcutaneous tissue were collected for analysis: the first soon after the incision, and a second before skin synthesis.
~The samples were processed by HPLC."
16141757|NCT01845350|Other|M2 macrophage introduction|"Generation of autologous M2 macrophages from peripheral blood of non-acute stroke patients
~Intrathecal introduction of autologous M2 macrophages"
16141758|NCT01845337|Drug|Teysuno|
16141759|NCT01845337|Drug|Capecitabine|
16141760|NCT01845311|Device|ReZolve2 Scaffold|
16141761|NCT01845298|Drug|Rifampicin 600 mg|The investigators will administer a single dose of rifampicin 600 mg to study subjects in order to conduct a pharmacokinetic study of rifampicin absorption.
16141762|NCT01845285|Device|Aortic Valve Replacement|Transthoracic Echo (TTE),CT Scan (ECG triggered, contrast enhanced),Aorto-Iliac Angiogram,Peripheral Evaluation,Coronary Evaluation,12 lead ECG,Arrhythmia Assessment, New York Heart Association (NYHA) functional status, Modified Rankin Score Assessment (mRS) if symptomatic for stroke, Current Cardiac Medications, Transthoracic echo (TTE)
16141763|NCT01845272|Drug|candesartan cilexetil 32mg, amlodipine 10mg|Treatment A (candesartan 10 days), at least 4 days wash-out, Treatment B (candesartan + amlodipine 10 days, 2-period, 2-treatment crossover
16141764|NCT01845272|Drug|candesartan cilexetil 32mg, amlodipine 10mg|Treatment A (amlodipine 10 days), at least 4 days wash-out, Treatment B (candesartan + amlodipine 10 days, 2-period, 2-treatment crossover
16141765|NCT01845259|Drug|Liraglutide|Once a day 1,8 mg subcutaneous injection for 16 weeks
16141766|NCT01845259|Drug|Liraglutide Placebo|Once a day 1,8 mg subcutaneous injection for 16 weeks
16141767|NCT01845246|Device|Prospective TDM Arm of colistin|
16141768|NCT01845220|Drug|Broccoli Sprout Extract|150 nanomol of sulforaphane/cm2 of skin in 80% acetone for 3 applications on 3 successive days prior to alcohol challenge
16141769|NCT01845220|Drug|Placebo|80% acetone
16141770|NCT01845194|Drug|Codeine|"Treatment period 2:
~5 mg Codeine once"
16141771|NCT01845194|Drug|Midazolam|"Treatment period 1:
~0.2 mg Midazolam 3x
~Treatment period 2:
~1 mg Midazolam once"
16141772|NCT01845194|Drug|Pravastatin|"Treatment period 2:
~5 mg Pravastatin once"
16141773|NCT01845194|Drug|Torsemide|"Treatment period 1:
~2.5 mg Torsemide 3x
~Treatment period 2:
~0.25 mg Torsemide once"
16141774|NCT01845194|Drug|Talinolol|"Treatment period 1:
~50 mg Talinolol 3x
~Treatment period 2:
~2.5 mg Talinolol once"
16141775|NCT01845194|Drug|Caffeine|"Treatment period 1:
~50 mg Caffeine 3x"
16141776|NCT01845194|Drug|Metoprolol|"Treatment period 1:
~5 mg Metoprolol 3x"
16141777|NCT01845181|Drug|PBF-680|Dose: 10, 20, 40 ,60 mg/day (making combination of 5 y 20 mg forms).
16141778|NCT01845181|Drug|Placebo|1 or 2 or 3 capsules of placebo.
16141987|NCT01843686|Other|Placebo Saline Gel and Usual and Customary Standard of Care|
16141988|NCT01843673|Procedure|computed tomography|Undergo FBCT
16141779|NCT01845168|Other|Computer-alert|A computer-alert which is activated when the physician is making a prescription for ASA or NSAID. Only for patients with riskfactors such as: Age over 60, males-gender, NSAID and ASA in kombination, Adenosine-diphosphate-inhibitor (ADP-inhibitor), blood-thinning medicine, Selective serotonin reuptake-inhibitor (SSRI) and steroids
16141780|NCT01845168|Device|A computer alerts which pops up when the GP presribes NSAID/ASA to a patient with risk-factors|A computer-alert which is activated when the physician is making a prescription for ASA or NSAID. Only for patients with riskfactors such as: Age over 60, males-gender, NSAID and ASA in combination, ADP-inhibitor, bloodthinning medicine, SSRI, and steroids
16141781|NCT01845168|Device|Computer-alert|
16141782|NCT01845155|Behavioral|Neuro-Music-Therapy according to the Heidelberg Model|"The neuro-music therapy according to the Heidelberg Model for tinnitus is a manualized short term music therapeutic treatment lasting for nine consecutive 50-minutes sessions of individualized therapy. Therapy takes place on five consecutive days (from Monday to Friday) with two therapy sessions per day. It comprises both active and receptive forms of music therapy. The interventions are structured into the following modules Directive Counseling, Resonance Training, Neuroauditive Cortex Training, Tinnitus Reconditioning.
~For more details on the music therapy see Argstatter et al. 2012"
16141783|NCT01845155|Behavioral|Counselling|Duration: single session of 50 min Tinnitus specific procedures: The counseling group receives the identical counselling procedure as the music therapy group.
16141784|NCT01845142|Drug|single administration of 100.000 I.U. vitamin D|
16141785|NCT01845142|Drug|Placebo|
16141786|NCT01845129|Device|atDCS|atDCS will be delivered with a constant current of 1 mA during simultaneous resting-state (RS) and task-related (picture naming) functional magnetic resonance imaging (fMRI). The current will be turned on prior to the RS-fMRI scan and continues for 20 minutes.
16141787|NCT01845129|Device|sham tDCS|During sham the current will be increeased and decreased in a ramp-like fashion (10 sec)
16141788|NCT01845116|Drug|Omegaven®|10% Omegaven® initiated at a starting dose of 0.5g/kg/day for two days and then advancing to the goal dose of 1g/kg/day, IV (in the vein) until the patient no longer requires parenteral nutrition or until participation in the study is terminated.
16141789|NCT01845090|Drug|Lanthanum carbonate|the effect on serum FGF23
16141790|NCT01845090|Drug|Calcium Carbonate|Calcium carbonate 500mg~1000 mg tid for 6 months
16141791|NCT01845077|Drug|2x500 mg Metformin (Glumetza)|2 tablets
16141792|NCT01845077|Drug|5 mg Linagliptin/1000 mg Metformin FDC|FDC tablet
16141793|NCT01845077|Drug|5 mg Linagliptin (Tradjenta)|1 tablet
16141794|NCT01845077|Drug|5 mg Linagliptin (Tradjenta)|1 tablet
16141795|NCT01845077|Drug|3x500 mg Metformin (Glumetza)|3 tablets
16141796|NCT01845077|Drug|5 mg Linagliptin (Tradjenta)|1 tablet
16141797|NCT01845077|Drug|2 x 500 mg Metformin (Glumetza)|2 tablets
16141798|NCT01845077|Drug|5 mg Linagliptin/1000mg Metformin FDC|FDC Tablet
16141799|NCT01845077|Drug|2 x 2.5 mg Linagliptin/750 mg Metformin FDC|2 FDC tablets
16141800|NCT01845064|Drug|DM199|
16141801|NCT01845064|Drug|Placebo|
16141802|NCT01845038|Drug|OTX-TPa ~4µg/day over 2 mos. with natural tears drops|OTX-TPa is a hydrogel punctum plug eluting travoprost in a sustained release of ~4µg/day over 2 months. Subjects in this arm will also receive natural tears drops.
16141803|NCT01845038|Drug|OTX-TPb ~3µg/day over 3 months with natural tears drops|OTX-TPb is a hydrogel punctum plug eluting travoprost in a sustained release of ~3µg/day over 3 months. Subjects in this arm will also receive natural tears drops.
16141804|NCT01845038|Drug|Timolol Maleate (0.5%) dosed twice daily with punctum plug without drug|Timolol Maleate (0.5%) ophthalmic solution dosed twice daily. Subjects in this arm will also have a hydrogel punctum plug without drug placed.
16141805|NCT01845025|Drug|Formoterol 12 mcg|Formoterol 12 mcg one inhalation twice daily, via dry powder inhaler
16141806|NCT01845025|Drug|Fluticasone propionate 100 mcg|Fluticasone propionate 100 mcg one inhalation twice daily via dry powder inhaler
16141807|NCT01845025|Drug|Fluticasone propionate 250 mcg|Fluticasone propionate 250 mcg one inhalation twice daily via dry powder inhaler
16141808|NCT01845025|Drug|Fluticasone propionate 500 mcg|Fluticasone propionate 500 mcg, one inhalation twice daily via dry powder inhaler
16141809|NCT01845025|Drug|Placebo|Placebo to match formoterol one inhalation twice daily via dry powder inhaler
16141810|NCT01845012|Other|Daily hemodialysis at low dialysate flow|Daily hemodialysis at low dialysate flow during 3 months: 6 times 2h to 2h30 per week at a dialysate flow rate of 200 ml/min in order that the total duration of weekly dialysis is equivalent to the duration of weekly dialysis during the last 3 months of conventional hemodialysis. Other parameters of dialysis (dialysate, dialysis machine, generator, blood flow, anticoagulation) are the same as the reference period of conventional hemodialysis.
16141811|NCT01844999|Behavioral|Personal Patient Profile - Prostate (P3P)|Website supporting informed patient decision making about prostate cancer care through tailored education and coaching
16141812|NCT01844999|Behavioral|Standard prostate cancer information websites|Standard prostate cancer information websites (e.g., NCI, ASCO) presented to patients in addition to patient education that is usual in their clinics
16141813|NCT01844986|Drug|Olaparib 300mg tablets|Olaparib/placebo tablets p.o 300mg twice daily for up to 2 years or until objective radiological disease progression as per RECIST as assessed by the Investigator. Patients with evidence of stable disease (or those who have progressed), may continue on treatment beyond 2 years, if in the patient's best interest. Dose reduction to 250mg and subsequently 200mg is permitted following confirmation of toxicity.
16141814|NCT01844973|Drug|M518101|Proper quantity twice a day
16141815|NCT01844973|Drug|Vehicle|Proper quantity twice a day
16141816|NCT01844960|Procedure|Single Incision Gastric Band Insertion|Insertion of gastric band though single abdominal incision
16141817|NCT01844960|Procedure|Multiple Incision Gastric Band Insertion|Insertion of gastric band though multiple abdominal incisions
16141860|NCT01844609|Behavioral|Self Study Journal Club|This Self Study Journal Club will read articles and prepare written answers to the study questions on their own time. The participants will read 24 articles; 12 gynecology and 12 obstetrics, based on monthly journal clubs available online at the Obstetrics and Gynecology website. The first and last article will serve as a basis for the oral and written exam in which they will be tested on comprehension, verbal and written Medical English.
16141818|NCT01844947|Drug|Vinflunine|"Vinflunine (Javlor®, Pierre Fabre Pharma): 320 mg/m2 I.V., day 1, repeated every 21 days for patients with PS 0, adequate renal (creatinine clearance >60 ml/min) and hepatic function (as described in the inclusion criteria). PLEASE NOTE THAT THE 320 mg/m2 ARM IS CLOSED FOR RECRUITMENT.
~For patients with PS 1, or age 75 to 80 years, or exposed to radiation of the lower pelvis region, or with impaired renal function (creatinine clearance 40-60 ml/min) but adequate hepatic function (as described in the inclusion criteria), the dose of vinflunine is 280 mg/m2 I.V. day 1, repeated every 21 days."
16141819|NCT01844947|Drug|Sorafenib|"Sorafenib (Nexavar®, Bayer HealthCare) daily dosage from day 2 through day 21 (repeated every 21 days):
~Step 1: 400 mg P.O. (i.e. one (1) tablet 200 mg morning and evening, 1+0+1) Step 2: 600 P.O. (i.e. one (1) tablet 200 mg morning and two tablets evening, 1+0+2) Step 3: 800 mg P.O. (i.e. two (2) tablets 200 mg morning and evening, 2+0+2) Doses of sorafenib higher than 400 mg P.O. b.i.d. are not allowed."
16141820|NCT01844934|Other|Prehabilitation|The three week, 3 days / week prehabilitation exercise program will consist of resistance training, step training and stretching(flexibility) as well as cardiovascular endurance training. Intensity of training will increase over the three weeks. Classes will be delivered over a four week period with a gap during the third week allowing additional time for participants to practice their exercises. The home exercise program will be designed to account for the additional week.
16141821|NCT01844908|Procedure|Electroacupuncture|
16141822|NCT01844895|Drug|Abatacept|
16141823|NCT01844869|Drug|omacetaxine mepesuccinate|
16141824|NCT01844856|Drug|Eravacycline|
16141825|NCT01844856|Drug|Ertapenem|
16141826|NCT01844856|Drug|Placebo|Administered IV to maintain the blind.
16141827|NCT01844843|Device|TCD-10023 drug eluting stent|Implantation of new drug eluting stent in coronary artery lesions
16141828|NCT01844830|Drug|Tetracaine HCl 3% and Oxymetazoline HCl 0.05%|Intranasally administered regional anesthetic
16141829|NCT01844830|Drug|Placebo|Inactive ingredients supplied in identical nasal sprayer
16141830|NCT01844817|Drug|OGX-427|Three separate administrations of OGX-427 will be given during the 9-day Loading Dose Period. Following the Loading Dose Period, patients will receive 600mg OGX-427 prior to the administration of nab-paclitaxel (125mg/m2 IV)and gemcitabine (1000mg/m2 IV)administration on Day 1, 8, and 15 of each cycle. OGX-427 will also be administered on Day 22 during each cycle (i.e., weekly). Patients will continue 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.
16141831|NCT01844817|Drug|Placebo|Three separate administrations of Placebo will be given during the 9-day Loading Dose Period. Following the Loading Dose Period, patients will receive placebo prior to the administration of nab-paclitaxel (125mg/m2 IV)and gemcitabine (1000mg/m2 IV)administration on Day 1, 8, and 15 of each cycle. Placebo will also be administered on Day 22 during each cycle (i.e., weekly). Patients will continue 28 day treatment cycles until disease progression or until other reasons for discontinuation from treatment.
16141832|NCT01844804|Biological|PF-06438179|Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1
16141833|NCT01844804|Biological|Remicade|Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1
16141834|NCT01844804|Biological|Remicade|Single-dose of 10 mg/kg administered as an intravenous infusion in not less than 2 hours on Day 1
16141835|NCT01844791|Drug|OCZ103-OS|OCZ103-OS is given in combination with chemotherapy each cycle
16141836|NCT01844791|Drug|Platinum|Platinum is given as standard chemotherapy each cycle
16141837|NCT01844791|Drug|Gemcitabine|Gemcitabine is given as standard chemotherapy each cycle
16141838|NCT01844778|Drug|Tobramycin Inhalation Powder|Tobramycin Inhalation Powder was administered via TOBI® Podhaler (T-326 inhaler).
16141839|NCT01844778|Drug|Tobramycin inhalation solution|Tobramycin inhalation solution was administered via nebuliser
16141840|NCT01844778|Drug|Colistimethate|Colistimethate was administered via nebuliser.
16141841|NCT01844765|Drug|nilotinib|Nilotinib supplied in 50mg, 150mg, and 200mg capsules. It was administered orally at 230mg/m2, twice daily for up to 66 cycles (1 cycle = 28 days). Dose administration was rounded to the nearest 50mg dose (to a maximum dose of 400mg).
16141842|NCT01844752|Drug|NVN1000 1% Gel|Twice daily NVN1000 1% Gel for 12 weeks
16141843|NCT01844752|Drug|NVN1000 4% Gel|Twice daily NVN1000 4% Gel for 12 weeks
16141844|NCT01844752|Drug|Vehicle Gel|Twice daily Vehicle Gel for 12 weeks
16141845|NCT01844739|Drug|NVN1000 4% Gel|Applied topically twice daily
16141846|NCT01844739|Drug|Vehicle Gel|Applied topically twice daily
16141847|NCT01844726|Drug|GLYX-13|Single injection (5 mg/kg) of GLYX-13, an NMDAR partial agonist
16141848|NCT01844726|Drug|Placebo|Single injection of placebo (saline)
16141849|NCT01844713|Behavioral|Workbook|Subjects will read a workbook about sun protection
16141850|NCT01844700|Drug|Ziprasidone|random assignment to ZIP (20-160mg/d, bid dosing)
16141851|NCT01844700|Drug|aripiprazole, quetiapine, or risperidone|random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)
16141852|NCT01844687|Drug|CBD|Each subject in the study was tested on eight days, each day receiving a different combination of active/inactive cannabis cigarettes plus 0, 200, 400 or 800 mg of CBD in random order. Cigarettes contained either 0.01 or 5.30% THC. At each visit, participants were given four gelatin capsules containing lactose and 0 or 200 mg of CBD in combinations to achieve scheduled dose level.
16141853|NCT01844674|Drug|Tizanidine|Participants will receive tizanidine as single oral doses, 2 milligrams (mg) on Day 1 and repeated on Day 22, each following an overnight fast >/= 10 hours.
16141854|NCT01844674|Drug|Vemurafenib|Participants will receive vemurafenib as multiple oral doses, 960 mg twice daily on Days 2 to 22.
16141855|NCT01844661|Biological|CELYVIR|
16141856|NCT01844648|Drug|NH004 tropicamide|Intra-oral slow dissolving muco-adhesive thin film containing 1 mg tropicamide
16141857|NCT01844648|Drug|NH004 Placebo|Intra-oral slow dissolving muco-adhesive thin film
16141858|NCT01844635|Drug|Thymoglobulin|
16141859|NCT01844622|Other|Domperidone|Domperidone dosage may be increased depending on how well the patient responds. However before increasing the dosage, patients will have follow-up EKG to evaluate any possible side effects including irregular heartbeats.
16141982|NCT01843725|Drug|Capecitabine|dose escalation, from 1700 to 2500mg/m2/day 2 weeks out of 3
16141861|NCT01844609|Behavioral|Intensive Journal Club|This Intensive Journal Club will read articles and prepare written answers to the study questions along with a fluent English speaker. The participants will read 24 articles; 12 gynecology and 12 obstetrics, based on monthly journal clubs available online at the Obstetrics and Gynecology website. Participants will prepare oral presentations of the studies and answers to the study questions. They will have interactive sessions with this fluent English speaking monitor 3 times a week, one hour sessions for 8 weeks. The first and last article will serve as a basis for the oral and written exam in which they will be tested on comprehension, verbal and written Medical English.
16141862|NCT01844596|Behavioral|behavioral communication strategy|Community Health Workers with an additional tailored behavioral communication strategy.
16141863|NCT01844596|Behavioral|Behavioral communication strategy, plus smartphone-based tool|Community Health Workers with a tailored behavioral communication strategy, also equipped with smartphone-based tool linked to the AMPATH Medical Record System (AMRS).
16141864|NCT01844583|Drug|Alisertib|Alisertib tablets
16141865|NCT01844583|Drug|Esomeprazole|Esomeprazole capsules
16141866|NCT01844583|Drug|Rifampin|Rifampin capsules
16141867|NCT01844557|Other|Swallowing Exercises|Participants perform 3 swallowing exercises.
16141868|NCT01844557|Behavioral|Symptom Inventory|Participants complete an M.D. Anderson Symptom Inventory for Head and Neck Cancer Patients before swallowing exercise procedure.
16141869|NCT01844557|Behavioral|Questionnaires|Participants fill out 3 questionnaires after swallowing exercises. The questionnaires will take about 10 minutes to complete.
16141870|NCT01844544|Other|inspection of medical records|
16141871|NCT01844531|Drug|empagliflozin|single tablet empagliflozin
16141872|NCT01844531|Drug|metformin (Glucophage®)|single tablet metformin
16141873|NCT01844531|Drug|metformin (Glucophage®)|single tablet metformin
16141874|NCT01844531|Drug|empagliflozin|single tablet empagliflozin
16141875|NCT01844531|Drug|empagliflozin and metformin|FDC tablet empagliflozin and metformin
16141876|NCT01844531|Drug|empagliflozin and metformin|FDC tablet empagliflozin and metformin
16141877|NCT01844518|Biological|Abatacept|
16141878|NCT01844505|Biological|Nivolumab|
16141879|NCT01844505|Biological|Ipilimumab|
16141880|NCT01844505|Biological|Placebo for Nivolumab|
16141881|NCT01844505|Biological|Placebo for Ipilimumab|
16141882|NCT01844492|Behavioral|The PARTNER Intervention|The PARTNER intervention (PAiring Re-engineered ICU Teams with Nurse-driven Emotional Support and Relationship-building) consists of: 1) institution of a clinical pathway for family support overseen by ICU staff nurses; 2) advanced communication skills training for ICU staff nurses; 3) a multifaceted strategy to support implementation of the clinical pathway for family support.
16141883|NCT01844492|Other|ICU Usual Care Control|The control group will receive usual care, in which the frequency and content of clinician-family communication is determined by the clinical team according to their usual practice. No study ICU has a protocolized approach to family communication and instead clinicians determine the timing and frequency of communication with families. All sites have palliative care services.
16141884|NCT01844479|Device|diabetic foot orthotic|The Dynamic Foot Orthosis (DFO) is designed with a rolling link mechanism at the distal 3rd to reduce sliding friction at the metatarsal heads in addition to decreasing compressive forces. The relative sliding motion of two compliant surfaces over each other allows some deformation horizontally and lowers frictional resistance. The DFO addresses the friction element by accommodating the normal sliding and rolling motion at the distal 3rd of the foot during gait. Additionally, the DFO has a silicone layer at the metatarsal head and the remainder of the anterior section made of 2 separated orthotic layers that slide over each other. This provides an articulating surface to provide a relative motion between the orthotic segments while transmitting load.
16141885|NCT01844479|Other|Standard innersole|
16141886|NCT01844466|Procedure|Physiotherapy and speech therapy|
16141887|NCT01844453|Procedure|Endometrial Biopsy|The Local Endometrial Injury will be performed using the standard technique using a Pipelle sampling catheter in the outpatient department. After a speculum examination is performed and the cervix is well visualized, the Pipelle will be inserted gently through the cervical canal into the uterine cavity and advanced slowly until resistance is noted. At this point the internal piston is withdrawn to create negative suction and the Pipelle is gently maneuvered up and down alongside the uterine cavity wall. The Pipelle catheter is then withdrawn gently and any obtained specimen (uterine lining) will be sent for histopathological examination.
16141888|NCT01844440|Procedure|High resolution manometry|Subjects will undergo impedance / manometry recording with solid-state catheter systems, during a 30-min fasting and a 2-hour postprandial periods.
16141889|NCT01844427|Drug|Memantine|Memantine HCl is an NMDA antagonist currently FDA approved for the treatment of moderate to severe Alzheimer's-type dementia.
16141890|NCT01844427|Drug|Placebo|
16141891|NCT01844414|Behavioral|Parolee Comprehensive Care + Phone Coach|A nurse case managed and specialized hepatitis education program with the hepatitis A/B (HAV/HBV) vaccination series (to all eligible) and coach-facilitated mentoring (mostly by cell-phone).
16141892|NCT01844414|Behavioral|Parolee Brief HBV Program + Phone Coach|A brief hepatitis/HIV education program with the Hepatitis A/B vaccine series and coach-facilitated mentoring.
16141893|NCT01844414|Behavioral|Usual Care Group|Control Group: A brief general health information program with one-on-one coaching and the Hepatitis A/B vaccine
16141894|NCT01844401|Drug|Albuterol Spiromax®|Albuterol Spiromax® 180 mcg (administered as 2 actuations of 90 mcg of albuterol base/actuation ex-mouthpiece) orally inhaled, single dose
16141895|NCT01844401|Drug|ProAir® HFA|ProAir® HFA 180 mcg (administered as 2 actuations of 90 mcg of albuterol base/actuation ex-mouthpiece) orally inhaled, single dose
16141896|NCT01844388|Drug|carboxymethylcellulose based eye drop formula|1-2 drops of carboxymethylcellulose based eye drop formula in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
16141897|NCT01844388|Drug|carboxymethylcellulose sodium based eye drop solution|1-2 drops carboxymethylcellulose sodium based eye drop solution (REFRESH CONTACTS®) in each eye, a minimum of 4 times a day for 90 days. One of the 4 times a day may be to prepare the contact lens for insertion.
16141983|NCT01843699|Drug|Topiramate flexible dosage|
16141984|NCT01843699|Drug|Placebo matching tablets|
16141898|NCT01844375|Dietary Supplement|Carbohydrate group|The patients will be given 12.5% carbohydrates drink 800 mL the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning.
16141899|NCT01844375|Other|Control group|The patients will be given water 800 mL to drink the night before surgery, between 1900 and 2400 h, and another 400 ml in the morning.
16141900|NCT01844362|Procedure|uterine transplantation|Transplantation of the uterus from live donor and IVF treatment.
16141901|NCT01844336|Device|PBASE system 1.1 + CT100 (active treatment)|
16141902|NCT01844336|Device|PBASE system 1.1 + CT100 (placebo treatment)|
16141903|NCT01844323|Other|Palbociclib Formulation Reference|Single 45 mg dose; Dosage form is capsule taken orally.
16141904|NCT01844323|Other|Palbociclib Formulation Test|Single 45 mg dose; Dosage form is capsule taken orally.
16141905|NCT01844323|Other|Palbociclib Formulation Test|Single 45 mg dose; Dosage form is capsule taken orally.
16141906|NCT01844323|Other|Palbociclib Formulation Test|Single 45 mg dose; Dosage form is capsule taken orally.
16141907|NCT01844310|Drug|RAL+TDF+LPV/r|Group A will be assigned with RAL-based regimen (RAL+TDF+LPV/r).
16141908|NCT01844310|Drug|3TC+TDF+LPV/r|Group B will be assigned with 3TC+TDF+LPV/r
16141909|NCT01844297|Drug|TDF+3TC+EFV|
16141910|NCT01844284|Device|XIENCE PRIME®/XIENCE Xpedition™|Subjects receiving XIENCE PRIME®/XIENCE Xpedition™
16141911|NCT01844284|Device|Absorb™ BVS|Subjects receiving Absorb™ BVS
16141912|NCT01844271|Device|Low Level Laser (LLL)|"Comparison of different dosages of a Low Level Laser applied in six different locations of the knee extensor muscles of the lower limb non-dominant before a strenuous exercise.
~We performed stretching and warming up of the muscles involved, assessment of muscle pain, withdrawal of blood sample, test muscle function (MVC), application of dose of low level laser designated for each volunteer (0, 2, 6 or 10), performing eccentric contractions protocol in isokinetic dynamometer . After the protocol we evaluated muscle function, the DOMS, and blood analyzes in 1 minute, 1 hour, 24 hours, 48 hours 72 hours and 96 hours.
~In a second stage, the optimal dose defined by the first part of the study will be tested in two different powers, 100 and 400mW. The study was repeated in two experimental groups using the optimal dose established and the powers of 100 and 400mW that was randomly distributed in groups."
16141913|NCT01844258|Procedure|Modified technique|Peripheral 1-1.5 mm curvilinear capsulorhexis of anterior capsule
16141914|NCT01844258|Procedure|Traditional technique|Central 5-6 mm curvilinear capsulorhexis of anterior capsule
16141915|NCT01844245|Procedure|Radiofrequency ablation (RFA)|The RFA probe is introduced into bile duct. Bipolar electronic coagulation is performed to the tumorous segment.
16141916|NCT01844232|Drug|arbaclofen|Arbaclofen ER tablets, 20 mg, 30 mg and 40 mg
16141917|NCT01844219|Procedure|elective or emergency aortic surgery (including ascending, arch, descending thoracic aorta)|
16141918|NCT01844206|Drug|Epidural Morphine|Patients will be given 3mg epidural morphine, 24 hours after the initial dose.
16141919|NCT01844206|Drug|Epidural Saline|Patients will be given epidural saline 6ml, 24 hours after receiving epidural morphine 3 mg.
16141920|NCT01844193|Device|Compex Rehab|"Participants in this arm will use a Compex® Rehab unit for neuromuscular electrical stimulation starting with postoperative at-home day 1 and continue using the unit twice a day, every day, until a 10-week follow-up is reached. The unit produces a 380 microsecond biphasic curve and utilizes a four phase process for the treatment (Warm-up, Work, Relaxation, and Recovery) for a total treatment time of 20 minutes and 5 seconds per session. All frequencies are delivered at the maximum subjective tolerable intensity. Participants will control this intensity and be asked to select a level that is tolerable although mildly uncomfortable; they will be instructed to increase this intensity as tolerated."
16141921|NCT01844180|Drug|ONO-2952|
16141922|NCT01844180|Drug|ONO-2952 Matching Placebo|
16141923|NCT01844167|Procedure|Noxipoint Therapy (NT)|"• For severe chronic neck pain patients, cervical braces are recommended within the first 2-3 days of each treatment session. The patient has to avoid using the treated tissues/muscles during the Rest Period: Similar to all other cells, the muscle cell healing or regeneration takes time. Patients are instructed not to use the newly recovered muscle/tissue during the Rest Period, which is about three days if they are forty or younger, plus about one extra day for every 10 additional years of age. If the patient has extensive injured muscles, take two more days of rest. Ice packs may be used during or soon after the session to prevent Delayed Onset of Muscle Soreness (DOMS) from the TENS stimulation."
16141924|NCT01844167|Procedure|Physical therapy(PT)|•Placebo effect consideration: TENS is included in both arms to obfuscate the process. Using TENS in the PT arm serves both as a sham-therapy-equivalent to what is used in the NT arm to neutralize placebo bias, and as a meaningful therapeutic remedy. The subject is thus blinded. Placebo effect consideration: TENS is included in both arms to obfuscate the process. Using TENS in the PT arm serves both as a sham-therapy-equivalent to what is used in the NT arm to neutralize placebo bias, and as a meaningful therapeutic remedy. The subject is thus blinded.
16141925|NCT01844141|Drug|70% alcohol|After phenolization of the ingrown toenail the wound is irrigated with 15 cc solution of 70% alcohol plus 0.5% clorhexidine
16141926|NCT01844141|Drug|70% alcohol - 0.5% clorhexidine|In the intervention group five rounds of 3 ml wash of 70% alcohol - 0.5% clorhexidine was used to irrigate the exposed area of the nail to neutralize any residual effect of phenol and found out how much residual phenol is still in the wound.
16141927|NCT01844128|Dietary Supplement|weight loss|
16141928|NCT01844115|Drug|Placebo|
16141929|NCT01844115|Drug|Vilazodone|Viibryd
16141930|NCT01844102|Device|PrePex|PrePex is a sterile device for adult male circumcision, consisting of an inner ring, elastic ring, placement ring, and verification thread. Proper sizing is facilitated by a sizing accessory. The elastic ring is loaded on to the placement ring, which is then placed at the base of the penis. The inner ring is placed inside the foreskin. The elastic ring is then deployed around the foreskin, clamping the foreskin against the inner ring. PrePex is manufactured by Circ MedTech Limited, is certified CE - Class IIa in the European Union, and has been approved by the U.S. Food and Drug Administration.
16141931|NCT01844076|Drug|Quinacrine and Capecitabine|The Phase I portion of the study will aim to determine the tolerability of both agents in combinations when used at established clinical doses. This portion of the study will more closely resemble a pilot study or feasibility study rather than a dose escalation.
16141985|NCT01843699|Behavioral|4-session gambling cognitive restructuring|
16141932|NCT01844063|Genetic|Conventional plus BM-MSC treatment|Received conventional treatment and bone marrow mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×10e5/Kg,1×10e6/Kg,or 1×10e7/Kg, once a week, 8 times).
16141933|NCT01844063|Genetic|Conventional plus UC-MSC treatment|Received conventional treatment and bone marrow mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×10e5/Kg,1×10e6/Kg,or 1×10e7/Kg, once a week, 8 times)
16141934|NCT01844063|Drug|Conventional treatment|"Received conventional treatment including:
~A.antiviral drugs(Entecavir,Lamivudine,Adefovir dipivoxil,et al); B.Hepatoprotective drugs(Ademetionine1,4-butanethiosulfonate for Injection, Reduced Glutathione for Injection,Polyene Phosphatidylcholine, et al); C.Plasma."
16141935|NCT01844050|Drug|Chinese herbal medicine|According to the traditional Chinese medicine syndrome of subject to make up a prescription within the 35 kinds of chosen Chinese herbal medicine, and the dosage without limitation.
16141936|NCT01844050|Drug|Placebo|
16141937|NCT01844037|Device|OneShot Ablation System|Renal denervation
16141938|NCT01844024|Other|misoprostol by midwife|Women with incomplete abortion is diagnosed and treated with misoprostol by midwife
16141939|NCT01844011|Other|Daily electronic reminders|Women in the intervention arm will be sent either daily text messages on the weekdays on their cell phone or emails on the weekdays reminding them to track kick counts on the chart
16141940|NCT01843998|Drug|Sirolimus 0.1% Ointment|Sirolimus 0.1% ointment will be applied topically to all affected areas of the skin twice daily for 6 months or until progression or unacceptable toxicity.
16141941|NCT01843972|Drug|BI 691751|oral solution BI 691751, dose 6
16141942|NCT01843972|Drug|BI 691751|oral solution
16141943|NCT01843972|Drug|Placebo|placebo solution
16141944|NCT01843972|Drug|BI 691751|oral solution BI 691751, dose 2
16141945|NCT01843972|Drug|BI 691751|oral solution BI 691751, dose 5
16141946|NCT01843972|Drug|BI 691751|1 tablet
16141947|NCT01843972|Drug|BI 691751|oral solution BI 691751, dose 3
16141948|NCT01843972|Drug|BI 691751|oral solution BI 69175, dose 4
16141949|NCT01843972|Drug|BI 691751|oral solution BI 691751, dose 7
16141950|NCT01843972|Drug|BI 691751|oral solution BI 69175, dose 1
16141951|NCT01843933|Device|Capnography|Capnostream 20 Portable Capnography Monitor with Internal Printer by Oridion
16141952|NCT01843920|Drug|Timolol-dorzolamide (Glaucoma drops)|Patients will receive the standard post-operative drops regardless of what group you are in. The glaucoma drops will only be given to the experimental group.
16141953|NCT01843920|Drug|standard post-operative topical drops|Patients will receive the standard post-operative drops regardless of what group ther are in. The standard post-operative drops are Prednisolone acetate,Polymyxin B and Trimethoprim
16141954|NCT01843907|Behavioral|Empowerment|To give patients the necessary resources to take care of their own health
16141955|NCT01843907|Other|Conversation with nurse|To find out, if the nurse, using her ....
16141956|NCT01843894|Biological|RU-101|Recombinant human serum albumin
16141957|NCT01843881|Drug|Exendin 9, 39|Exendin 9,39 is a competitive antagonist of endogenous GLP-1.
16141958|NCT01843881|Drug|Placebo|A saline infusion will be given to match the study drug infusion.
16141959|NCT01843868|Drug|Standard anti-emetics in conjunction with R-CHOP|
16141960|NCT01843855|Drug|Exendin 9,39|Exendin 9,39 is a competitive antagonist of endogenous GLP-1.
16141961|NCT01843855|Drug|Placebo|A saline infusion will be given to match the study drug infusion.
16141962|NCT01843842|Drug|Ergoferon|Safety and Efficiency of liquid dosage form
16141963|NCT01843842|Drug|Placebo|Safety and Efficiency of liquid dosage form
16141964|NCT01843829|Drug|Oxaliplatin|
16141965|NCT01843829|Drug|Capecitabine|
16141966|NCT01843829|Drug|Carboplatin|
16141967|NCT01843829|Drug|Paclitaxel|
16141968|NCT01843829|Radiation|Radiotherapy|
16141969|NCT01843829|Procedure|Surgery|Patients will have their tumour surgically removed by two-phase oesophagectomy and two-field lymphadenectomy.
16141970|NCT01843803|Other|patient inventory|Patients in the intervention arm will complete an inventory of their preferences, resources, and life circumstances that may affect their care. The inventory will be completed on an iPad, and a copy of the results will be given to the patient's provider at the time of their visit.
16141971|NCT01843803|Other|attention control|Patients will view a brief healthy living video on an iPad
16141972|NCT01843790|Drug|GCS-100|The amount (in mg) of GCS-100 to be administered will be determined based on body surface area, which will be calculated based on body weight and height. The study drug dose should be calculated on Day 1. Drug should be added to an infusion bag or syringe containing 0.9% Sodium Chloride Injection, USP. Drug be infused into a large vein via a large bore catheter to avoid local irritation and administered at no more than 2 mg/mL in no less than 60 mL.
16141973|NCT01843790|Drug|Placebo, Saline|The amount (in mg) of drug to be administered will be determined based on body surface area, which will be calculated based on body weight and height. The drug dose should be calculated on Day 1. Drug should be added to an infusion bag or syringe containing 0.9% Sodium Chloride Injection, USP. Drug be infused into a large vein via a large bore catheter to avoid local irritation and administered at no more than 2 mg/mL in no less than 60 mL.
16141974|NCT01843777|Behavioral|Standard-of-Care|the standard of care in audiologic practice
16141975|NCT01843777|Behavioral|Treatment|motivational interviewing
16141976|NCT01843764|Device|HRP2 and LDH based rapid diagnostic tests for P.falciparum|
16141977|NCT01843751|Drug|buprenorphine/naloxone|Buprenorphine/naloxone (Suboxone) is considered a well-investigated, highly effective medication-assisted treatment for opiate dependence, but it may only be supervised through the few specialist treatment facilities in the state, or by physicians who have historically been less likely to offer this service. The effectiveness of community physician treatment supervision has not been tested for those in the criminal justice system.
16141978|NCT01843738|Radiation|Radiation therapy|Per standard of care
16141979|NCT01843738|Drug|Vemurafenib|The starting dose of vemurafenib will be the patient's baseline tolerating dose, between 720 - and 960 mg PO bid.
16141980|NCT01843725|Drug|capecitabine|escalation dose of capecitabine continuously
16141981|NCT01843725|Drug|aflibercept|Intravenous 6mg/kg every 3 weeks
16141989|NCT01843673|Procedure|cone-beam computed tomography|Undergo dual CBCT
16141990|NCT01843673|Procedure|radiography|Undergo 2-D x-ray with Varian kV OBI
16141991|NCT01843673|Procedure|radiography|Undergo 2-D x-ray with Brain Lab ExacTrac
16141992|NCT01843673|Procedure|radiography|Undergo 2-D x-ray with Varian MV OBI
16141993|NCT01843673|Procedure|electronic portal imaging|Undergo EPID imaging
16141994|NCT01843673|Radiation|image-guided adaptive radiation therapy|Undergo IGART
16141995|NCT01843660|Drug|Tramadol HCl-Paracetamol|Participants will receive 1 to 2 tablets of tramadol HCl-paracetamol orally once daily (each tablet containing tramadol 37.5 milligram [mg] and paracetamol 325mg) for up to a total duration of 6 hours. Additional dose may be given based upon the clinical requirement.
16141996|NCT01843647|Drug|Icotinib|Patients receive 8-week icotinib induction treatment before surgery and 1-year icotinib adjuvant therapy after surgery.Icotinib is administered orally with a dose 125 mg 3 times daily.
16141997|NCT01843647|Drug|Chemotherapy|"After surgery patients receive 4-cycle adjuvant chemotherapy with vinorelbine
~/cisplatin regimen, until untolerable toxicity or disease progression."
16141998|NCT01843634|Drug|ODSH|
16141999|NCT01843621|Biological|DEN vaccine F17|The dengue booster vaccine was administered subcutaneously in the non-dominant arm (deltoid). The tetravalent, live attenuated DEN F17 vaccine was administered in this study. This pre-transfection formulation contained dengue virus types 1, 2, 3 and 4 (DEN-1, -2, -3 and -4).
16142000|NCT01843608|Other|Physical Intervention|The exercise program will be designed and conducted by qualified in Physical Activity and Sport Sciences. The exercise program will consist in a combined two days per week of supervised training program and one day per week of briskly walking by themselves, following a document, designed by the specialist trainer, which will be given at the beginning of the program. The intervention will have a duration of 12 consecutive weeks. The intensity will be increasing progressively from 65% to 85% of heart rate. The intensity will be controlled by heart rate monitor trademark POLAR FT7 in aerobic exercise and with the number of repetitions (from 8 to 15) and sets (from 2 to 3) in strength exercises. Prescription intensity will be done using Karvonen equation, recommended method to work with risk population.
16142001|NCT01843595|Behavioral|REFIT Intervention|The intervention will include 2 face-to-face group meetings, weekly check-in sessions, weekly tailored feedback, and weekly lessons focused on specific weight loss behaviors. All participants will be encouraged increase their physical activity to approximately 250 minutes of moderate to vigorous physical activity per week.
16142002|NCT01843569|Biological|In Vitro maturation|
16142003|NCT01843556|Drug|E2022 Tape Formulation|E2022 tape formulation applied to different application sites and at different intervals in Japanese healthy elderly males
16142004|NCT01843543|Other|Mindfulness Based Stress Reduction Course|The MBSR course developed by Jon Kabat-Zinn is a mind-body intervention that incorporates mindfulness techniques. This is an eight week MBSR course at OHSU. Class instruction will be augmented by daily home practices of listening to audiotapes, diary reflections, and reading preloaded on itouch devices provided to participants. Adherence will be assessed through in-house iMINDr tracking program loaded on the itouch.
16142005|NCT01843530|Drug|Berinert|
16142006|NCT01843530|Drug|Clemastin|
16142007|NCT01843530|Drug|Cortisone acetate|
16142008|NCT01843530|Drug|NaCl|
16142009|NCT01843504|Biological|platelet rich plasma|A blood draw of 15 mL of the subject's own blood will be performed. The study coordinator will then place the sample in the Platelet Separator System (a centrifuge) and spin the blood sample in using a two-stage spinning: the 1st separates red blood cells from platelets, and the 2nd concentrates the platelets. This will be spun by centrifuge to yield 6 mL of concentrated autologous platelet. Under continuous ultrasound evaluation, 1.0-2.0 mL of the prepared PRP will be injected onto the origin of the patella tendon itself will be peppered along a short segment of the tendon into the areas of palpated tenderness and US-documented pathology.
16142010|NCT01843504|Other|saline|A blood draw of 15 mL of the subject's own blood will be performed to maintain blinding. Under continuous ultrasound evaluation, 1.0-2.0 mL of the saline solution will be injected onto the origin of the patella tendon itself will be peppered along a short segment of the tendon into the areas of palpated tenderness and US-documented pathology.
16142011|NCT01843491|Biological|Ad-PfCA|Vaccine
16142012|NCT01843478|Other|Self-Collected HPV Test|The HPV self-collected test is followed by results counseling by phone when the result is available (usually 2-3 weeks). Women are encouraged to have Pap testing.
16142013|NCT01843478|Other|Usual Care|
16142014|NCT01843465|Other|Maneuvers for documenting the disconnection|
16142015|NCT01843452|Radiation|RADIOTHERAPY|"External beam radiotherapy (daily fraction dose 1.8Gy) on Monday through Friday starting on study day 1.
~Days 1-28, dose of 36 Gy in 1.8 Gy/fraction (20 fractions) to the clinical target volume 1 (CTV1) including the primary tumor and involved lymph nodes and areas at risk for metastatic spread (which includes gross tumour volumes (GTV) and a 1-cm expansion, mesorectal space, inguinal, femoral, external iliac, internal iliac, and common iliac vessels).
~Days 29-45, a boost dose of 23.4 Gy in 1.8 Gy/fraction (13 fractions) to the GTV."
16142016|NCT01843452|Biological|PANITUMUMAB|6 mg/kg IV administered over 60 min infusion on days 1,15 and 29.
16142017|NCT01843452|Drug|MITOMYCIN|10 mg/m2 IV administered over 15 min infusion on days 1 and 29.
16142018|NCT01843452|Drug|CAPECITABINE|825mg/m2 orally twice daily on study days 1 through 45.
16142019|NCT01843439|Dietary Supplement|Magnesium|
16142020|NCT01843439|Behavioral|Education for asthma action plan|
16142021|NCT01843439|Behavioral|hot-lines for acute exacerbation of asthma|
16142022|NCT01843439|Behavioral|Inhaler technique training|
16142023|NCT01843426|Drug|Low-volume, low-concentration contrast (iodixanol - Visipaque 270) CT scan|An ECG-synchronized, contrast-medium enhanced CT study of the heart for the evaluation of the aortic root complex and general cardiac morphology will be obtained. This is immediately followed by a CT angiographic study of the chest, abdomen, and pelvis (beyond the femoral heads), which utilizes the same contrast bolus that is injected for evaluating the heart. This latter vascular study serves to evaluate the TAVR deployment catheter access route through the femoral, iliac, and aortic vascular stations. In clinical routine, we have been performing this type of study with total contrast media volumes ranging from 40-120 mL of iodinated contrast material.
16142024|NCT01843413|Radiation|stereotactic radiosurgery|Undergo SRS
16142027|NCT01843400|Drug|Regorafenib (Stivarga, BAY73-4506)|Patients treated with Regorafenib under practical manner for colorectal cancer.
16142028|NCT01843387|Biological|Mesenchymal Precursor Cells (MPCs)|Single Intravenous Infusion of MPCs Dose 1 or Placebo
16142029|NCT01843387|Biological|Mesenchymal Precursor Cells (MPCs)|Single Intravenous Infusion of MPCs Dose 2 or Placebo
16142032|NCT01843348|Drug|Everolimus|
16142033|NCT01843348|Drug|Tacrolimus|Capsules: 0.5 mg, 1 mg or 5 mg. Dosing schedule: transplant to month 2: 4-8ng/ml, month 3 to month 12 3-5 ng/ml according to standard blood levels
16142034|NCT01843348|Drug|Cyclosporin A|Capsules: 10 mg, 25 mg, 50 mg or 100 mg. Transplantation to month 2: 75 - 125 ng/ml, month 3 to month 12: 50 - 100 ng/ml
16142035|NCT01843348|Drug|Enteric Coated Mycophenolate Sodium (EC-MPS)|Tablets: 180 mg or 360 mg. Dosing: duration of study 360 mg bid and no less than 360 mg daily dose
16142036|NCT01843348|Drug|Mycophenolate mofetil (MMF)|Capsules: 250 or 500 mg. Dosing: duration of study 500 mg bid and no less than 500 mg total daily dose
16142037|NCT01843348|Drug|Corticosteroids|A minimum dose of 5 mg prednisolon or equivalent
16142038|NCT01843348|Drug|Simulect|Lyophilisate in vials with ampoules of sterile water for injection (5 mL), one vial containing 20 mg lyophilisate given intravenously on the day of transplantation and on day four post-transplantation.
16142039|NCT01843322|Procedure|endoleak repair procedure (navigation technology )|
16142040|NCT01843309|Drug|Spironolactone 100mg|
16142041|NCT01843309|Drug|Spironolactone 200mg|
16142042|NCT01843309|Drug|Placebo|
16142043|NCT01843296|Drug|Magnesium Sulfate|Injection of 50 mg of magnesium sulfate 50% (0.1 ml),intrathecally.
16142044|NCT01843296|Procedure|Spinal Anesthesia|Lumbar puncture was performed in sitting position,at the one level above iliac crest. Using a median approach, a 25-G Quincke needle was introduced with the needle aperture directed laterally.
16142045|NCT01843296|Drug|Bupivacaine|
16142046|NCT01843296|Drug|Fentanyl|
16142047|NCT01843283|Behavioral|Daily Enhancement Meaningful Activity (DEMA)|
16142048|NCT01843283|Behavioral|Information Support (IS)|
16142049|NCT01843270|Device|actual body weight based size|According randomized allocated group, the laryngeal mask airway is inserted based on actual or ideal body weight-based sizes before the surgery.
16142050|NCT01843270|Device|ideal body weight based size|According randomized allocated group, the laryngeal mask airway is inserted based on actual or ideal body weight-based sizes before the surgery.
16142051|NCT01843257|Other|Alcohol challenge test Alcohol visit first|Subjects will be assessed in two testing sessions about 1 week apart, in which their response to alcohol or nonalcoholic (placebo) beverage will be evaluated in a randomized cross-over fashion (visit 1 alcohol, visit 2 placebo).
16142052|NCT01843257|Other|Alcohol challenge test Placebo visit first|Subjects will be assessed in two testing sessions about 1 week apart, in which their response to alcohol or nonalcoholic (placebo) beverage will be evaluated in a randomized cross-over fashion (visit 1 placebo, visit 2 alcohol).
16142053|NCT01843231|Device|g-CathTM EZ Suture Anchor Delivery Catheter|Use of the g-Cath EZ Suture Anchor Delivery Catheter for the placement of g-cath EZ suture anchors as an early weight loss intervention + diet and exercise as compared to those in the diet and exercise control group
16142054|NCT01843231|Other|Diet and Exercise Control Group|Patients in a diet and exercise only control group that will be compared to those in the g-Cath EZ Suture Anchor Delivery Catheter treatment group
16142055|NCT01843218|Other|Evaluation of erectile dysfunction|Register R / P and self-administered questionnaire IIEF-5
16142056|NCT01843205|Drug|Methamphetamine|The pharmacodynamic effects of methamphetamine will be determined during placebo and buspirone maintenance.
16142057|NCT01843205|Drug|Placebo|The pharmacodynamic effects of placebo methamphetamine will be determined during placebo and buspirone maintenance.
16142058|NCT01843192|Device|Endocutter|
16142059|NCT01843179|Drug|Cytarabine|Up to two cycles. Administered via IV infusion on Days 1-5 of each 28 day cycle
16142060|NCT01843179|Drug|Sulindac|Taken orally twice per day at home for 12 months
16142061|NCT01843166|Drug|Premarin vaginal cream|2g at bedtime twice weekly
16142062|NCT01843166|Drug|Placebo cream|2g at bedtime twice weekly
16142063|NCT01843153|Drug|Ropivacaine|
16142064|NCT01843127|Drug|Ranolazine|
16142065|NCT01843127|Drug|Placebo|
16142066|NCT01843127|Drug|Exenatide|
16142067|NCT01843114|Device|FDOCT|Measurement of retinal blood velocities
16142068|NCT01843114|Other|Dynamic Vessel Analyzer|Measurement of retinal vessel diameters
16142069|NCT01843101|Device|Optical Coherence Tomography|Imaging of the cornea using ultrahigh resolution Spectral Domain OCT
16142070|NCT01843088|Drug|Mannitol cream|25% mannitol in PENcream (See above) (See above) This will be applied as needed to one side of the body (blinded assignment) over painful painful areas of legs following a 10 km run, on the day of the run and for five days afterwards.
16142071|NCT01843088|Drug|Placebo Cream|This is the vehicle only cream (PENcream) (See above) This will be applied as needed to one side of the body (blinded assignment) over painful painful areas of legs following a 10 km run, on the day of the run and for five days afterwards.
16142072|NCT01843075|Drug|Liraglutide|Daily subcutaneous injection
16142073|NCT01843075|Drug|Placebo|Daily subcutaneous injection
16142074|NCT01843062|Drug|Selumetinib|3 capsules of 25 mg strength orally twice a day for approximately 5 weeks treatment period
16142075|NCT01843062|Drug|Placebo|3 capsules ( to match Selumetinib capsules) orally twice a day for approximately 5 weeks treatment period
16142076|NCT01843062|Drug|Radioactive Iodine Therapy|A single oral radioactive iodine dose of 100 mCI(3.7 GBq) 131I (+/-10% at the time of administration)to be administered 30 days after randomization. Additionaly, Thyrogen (Recombinant human TSH) will be used to stimulate iodine uptake according to the manufacturer's recommendation(0.9 mg intramuscular injection once a day for the 2 days prior to the dose of radioactive iodine)
16142077|NCT01843049|Radiation|Radiotherapy|Patients will receive from 5 to 6 weeks 5 days a week radiations. The dose of radiation will depend on the level they will be included.
16142078|NCT01843049|Drug|Chemotherapy (5-FU+DDP)|Patients will receive 2 cycles of concurrent chemotherapy (cisplatin 25mg/m2 IV daily on Days 1-3 and 29-31 plus 5-FU 500mg/m2 IV continuous infusion over 24h daily on Days 1-4 and 29-32) during radiotherapy period. Consolidation chemotherapy (cisplatin 25mg/m2 IV daily on Days 1-3 plus 5-FU 600mg/m2 IV daily on Days 1-5, cycled every 4 weeks) will be given for 2 cycles one month after the end of radiochemotherapy.
16142079|NCT01843036|Other|Durham Connects|Durham Connects begins with a visit during the birthing hospital stay, followed by 1-3 nurse home visits between 4-12 weeks of infant age, and then a follow-up contact one month later. During the visits, the nurse engages with the mother and completes a health and psychosocial assessment, during which she systematically assesses risk and family needs in 12 important empirically-derived areas of family functioning across 4 domains (i.e. - healthcare, parenting/childcare, family violence/safety, and maternal well-being). For each domain found to be at risk, the nurse intervenes directly to support the mother (mild risk) or connects the mother with matched community resources as needed to address individualized long-term family needs (moderate or severe risk).
16142080|NCT01843023|Drug|Extended Release Naltrexone|naltrexone for extended release injectable suspension
16142081|NCT01843023|Behavioral|Psychosocial Treatment|Psychosocial treatment will consist of group and individual drug abuse counseling at MMTC and in the community.
16142082|NCT01843023|Drug|Buprenorphine|Participants assigned to TAU will receive buprenorphine for opioid withdrawal and will either be tapered off the medication or will remain on it for individualized lengths of time during the six month study.
16142083|NCT01843010|Drug|Parecoxib|Parecoxib 40mg will be intravenously infused.
16142084|NCT01843010|Drug|Placebo|Normal saline 5ml will be intravenously infused.
16142085|NCT01842997|Biological|split-virion, non-adjuvanted H1N1 vaccine of 15 μg|122 participants (19 at 5-9 weeks pregnant,36 at 10-19 weeks pregnant,13 at 20-29 weeks pregnant,54 at more than 30 weeks pregnant) received split-virion, non-adjuvanted H1N1 vaccine of 15 μg.
16142086|NCT01842984|Behavioral|I-SOCIAL intervention|The I-SOCIAL intervention is based on findings from Cohen-Mansfield and Parpura-Gill (2007), which highlighted the important role of barriers in contributing to loneliness in older persons. These barriers include a perceived lack of opportunities for social contacts, low social self-efficacy, and health and mobility difficulties. The intervention includes: (1) identifying the barriers for the specific person; (2) up to 10 meetings with an activities counselor. The meetings include discussions concerning options for social contacts and use of techniques and resources to tackle the barriers; and (3) group meetings of participants and the activities counselors in order to provide a concrete social event and as a venue to discuss barriers and ways to address them.
16142087|NCT01842971|Procedure|two stage hepatectomy|
16142088|NCT01842958|Device|Straumann Bone Level Implants, 4.1 mm implant diameter|Straumann Bone Level Implants, 4.1 mm implant diameter
16142089|NCT01842958|Device|Straumann Bone Level Implants, 3.3 mm implant diameter|Straumann Bone Level Implants, 3.3 mm implant diameter
16142090|NCT01842945|Behavioral|Internet-based cognitive behavioural therapy (iCBT) without therapist contact.|The iCBT consists of our structured self-help program lasting a total of eight active treatment weeks and does not include a therapist contact.
16142091|NCT01842945|Behavioral|Internet-based cognitive behavioural therapy (iCBT) with therapist contact.|The iCBT consists of our structured self-help program lasting a total of eight active treatment weeks and includes a therapist contact.
16142092|NCT01842932|Drug|Phloroglucin|Premedication of colonoscopy
16142093|NCT01842932|Drug|Cimetropium bromide|Premedication of colonoscopy
16142094|NCT01842932|Procedure|Colonoscopy|Diagnostic examination of colon
16142095|NCT01842932|Drug|Placebo|Placebo for double-blind study These are harmless to the human body, and are composed of saline solution without drug efficacy.
16142096|NCT01842919|Other|Kinesthetics tests|
16142097|NCT01842919|Other|Psychological questionnaires|
16142098|NCT01842919|Other|structural Magnetic ResonanceImaging (MRI)|
16142099|NCT01842906|Device|Theravent|nasal EPAP device
16142100|NCT01842906|Device|Control|Sham device without EPAP
16142101|NCT01842893|Drug|Fentanyl Ethypharm|After an open-label titration to identify an optimal dose, patients were randomized to 1 of 13 prespecified sequences of 9 tablets (6 fentanyl and 3 placebo)
16142102|NCT01842841|Drug|velaglucerase alfa|15-60 U/kg, EOW
16142103|NCT01842828|Other|Standard care plus electronic cigarettes|
16142104|NCT01842828|Behavioral|Standard care|
16142105|NCT01842815|Device|755 nm alexandrite laser|755 nm alexandrite laser for the treatment of unwanted, non cosmetic, tattoos.
16142106|NCT01842802|Device|Diode Laser|Diode Laser for treatment of subcutaneous fat
16142107|NCT01842802|Device|YAG laser|YAG laser for treatment of subcutaneous fat
16142108|NCT01842789|Device|Acessa Procedure|Acessa Procedure
16142109|NCT01842750|Device|Endorectal Balloon insertion|
16142110|NCT01842737|Procedure|Spinal treatment|This treatment will be applied to the low back region only. During a HVLA treatment, the study doctor will ask the participant to lie on their side on a treatment table. After carefully helping the participant into the proper position, the doctor will make a quick and controlled push with their hand to slightly move joints in the low back. During this procedure, the participant may feel and/or hear a popping sound. After treatment, the doctor may ask the participant to rest on the table for a few moments. During palpation procedure, the doctor will touch several areas in the low back while asking questions about pain, tenderness and other sensations felt during this procedure. The participant will watch the doctor perform the palpation procedure in real time with a tablet computer.
16142111|NCT01842737|Procedure|Massage|The study doctor will perform a massage of each foot while the participant lies face up in a relaxed position on a treatment table. The procedure will last approximately 10-20 minutes including massage to the toes, heel, sole, and top of each foot.
16142112|NCT01842724|Procedure|Motec total wrist arthroplasty|
16142113|NCT01842724|Procedure|Remotion total wrist arthroplasty|
16142114|NCT01842698|Device|ultrasoundguided paravertebral catheter|
16142115|NCT01842685|Procedure|Bladder Thermal Distention|Bladder Thermal Distention is an approved procedure in Europe from 2006. The treatment is hydrodistention of the bladder with a warm saline (up to 45C). The procedure lasts 1 hour. The saline is infused constantly through a 3 ways specific catheter (Unithermia 18F) by the PelvixTT system.
16142118|NCT01842659|Genetic|Methylation Index|To calculate the methylation index (MI) of imprinted regions.
16142119|NCT01842646|Drug|PF-04449913|Patients will be enrolled according to a two-step study design. Twenty patients will be enrolled in the first stage. All patients will be given a daily oral dose of PF-0444913 100 mg for up to 4 cycles, with an optional continuation phase. Dose escalation to 200 mg will be provided for patients who do not have at least hematologic improvement following 2 cycles, and dose reduction to 50 mg will be permitted for patients with significant toxicity. If at least 2 patients respond in the initial stage, and additional 15 patients will be enrolled in the second stage.
16142120|NCT01842633|Drug|Paracetamol and Caffeine|Caplets containing 500 milligrams (mg) of paracetamol and 65 mg of caffeine
16142121|NCT01842633|Drug|Ibuprofen|Caplets containing 200 mg of ibuprofen
16142122|NCT01842633|Other|Placebo|Matching placebo caplets
16142123|NCT01842620|Drug|Metformin|Oral antidiabetic agent
16142124|NCT01842607|Biological|Mepolizumab|Mepolizumab (a fully humanised IgG antibody) 100 mg injected SC once every 4 weeks for 12 months. Mepolizumab will be provided as a lyophilised cake in sterile vials
16142125|NCT01842594|Drug|Sirolimus and hydroxychloroquine|"Both hydroxychloroquine 200 mg/tab and sirolimus 1 mg/tab are pills each are taken 2 tablet orally QD for 2 cycles .
~Each treatment cycle is 28 days."
16142126|NCT01842581|Drug|Rifaximin|Rifaximin will be administered per the dose and schedule specified in the arms.
16142127|NCT01842581|Drug|Lactulose|Laculose will be administered per the schedule specified in the respective arm.
16142128|NCT01842555|Other|Registry|Registry
16142129|NCT01842542|Device|NeuroStar Transcranial Magnetic Stimulation (TMS)|"Acute phase: 120% of observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/session, five times weekly for up to 8 weeks.
~3 week taper phase: 120% of observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/session, 3 times during the first week, 2 times during the second week and one time during the third week. In addition to treatments, patients may receive treatment as usual at the direction of their treating physician."
16142130|NCT01842529|Biological|botulinum toxin injection|
16142131|NCT01842529|Biological|0.9% normal saline injection|
16142132|NCT01842529|Device|Implantable loop recorder|
16142133|NCT01842516|Drug|LCB01-0371 800mg|LCB0-0371 800mg
16142134|NCT01842516|Drug|LCB01-0371 1200mg|LCB01-0371 1200mg
16142135|NCT01842516|Drug|Placebo|Placebo
16142136|NCT01842503|Drug|GET 73|300 mg tid on 3 days cycle
16142137|NCT01842503|Drug|inactive ingredients capsule|3 capsules tid on 3 days cycle
16142138|NCT01842477|Procedure|Implantation of bone substitute plus autologous cultured mesenchymal cells|Implantation surgery of a synthetic bone substitute associated with autologous bone marrow cells expanded
16142139|NCT01842464|Procedure|Anterior Sacro-Spinous|Anterior Sacro-Spinous
16142140|NCT01842451|Drug|VX-135|
16142141|NCT01842451|Drug|Daclatasvir|
16142142|NCT01842438|Behavioral|Behavioral: psychosexual intervention|6 session manualised intervention, This manual-based family-relational-psychosexual support was based on systemic principles combined with techniques from sex therapy, i.e. sensate focus. The manual offered an intermediate level of specificity, enabling practitioners to use their own therapeutic style and take some lead from the couple while meeting the objectives of the intervention. Specialist training in delivery of the intervention was provided to practitioners holding accredited counselling or psychotherapy qualifications. Practitioners engaged in routine clinical supervision with one additional team supervision session offered by one of the practitioners
16142143|NCT01842412|Behavioral|exercise|one bout of exercise training
16142144|NCT01842399|Dietary Supplement|Resveratrol|Dietary Supplement
16142145|NCT01842399|Drug|Placebo|2x/day orally
16142146|NCT01842386|Drug|Rituximab|Subjects will receive intravenous (IV) infusions of rituximab 1 gram on days 1 and 15, and subsequently if indicated up to once a month for 5 months (+/-5 days for each visit) starting approximately on day 42. Subjects whose infections respond positively to the treatment but then relapse may be offered additional treatment.
16142147|NCT01842373|Drug|LMX4|
16142148|NCT01842373|Drug|BLT|
16142149|NCT01842360|Biological|Placebo|The subjects will receive daily dose of placebo during 12 months
16142150|NCT01842360|Biological|MV130|The subjects will receive daily dose of MV130 during 12 months
16142151|NCT01842347|Other|Fecal microbiota|
16142152|NCT01842334|Behavioral|Cognitive Behavioral Therapy|CBT administered to to both DCS and placebo group.
16142153|NCT01842334|Drug|Nicotine Replacement Therapy|NRT administered to both DCS and placebo group.
16142154|NCT01842321|Drug|Abiraterone Acetate|Patients will receive abiraterone acetate at 1,000 mg (four 250 mg tablets daily in the morning after an overnight fast) concurrently with prednisone(1) at 10 mg once daily.
16142155|NCT01842308|Procedure|Autologous Bone Marrow Transplantation|Undergo autologous stem cell transplant
16142156|NCT01842308|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo autologous stem cell transplant
16142157|NCT01842308|Drug|Carfilzomib|Given IV
16142158|NCT01842308|Other|Laboratory Biomarker Analysis|Correlative studies
16142159|NCT01842308|Drug|Melphalan|Given IV
16142160|NCT01842295|Other|Blood and sperm samples|Blood and sperm samples will be done in each visit
16142161|NCT01842282|Drug|Amlexanox|
16142162|NCT01842269|Drug|Mycophenolate Mofetil 500mg|
16142163|NCT01842269|Drug|Mycophenolate Mofetil 250mg|
16142164|NCT01842256|Drug|Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg|"3 Tablets (telmisartan 80mg, amlodipine 5mg, atorvastatin 40mg each one),
~oral intake, once in a period
~over the period Ⅰ&Ⅱ(crossover)"
16142165|NCT01842256|Drug|atorvastatin 40mg|"1 Tablet (atorvastatin 40mg),
~oral intake, once in a period
~over the period Ⅰ&Ⅱ(crossover)"
16142166|NCT01842243|Procedure|Apical pacing|Pacemaker set to pace at right ventricular apex initially.
16142167|NCT01842243|Procedure|Septal pacing|Pacemaker set to pace at right ventricular septum initially.
16142168|NCT01842243|Device|Pacemaker|MR conditional Pacemaker implanted in all study patients
16142386|NCT01840579|Drug|Nab-paclitaxel 100 mg/m^2|Administered as an IV infusion on Days 1, 8, and 15 of each 21-day cycle
16142169|NCT01842230|Drug|Telmisartan 80mg, S-amlodipine 5mg and Atorvastatin 40mg|"Telmisartan 80mg, S-amlodipine 5mg: 1 tablet, oral, once daily, 1day
~Atorvastatin 40mg: 1 tablet, oral, once daily, 2days
~over the period I & II(cross-over)"
16142170|NCT01842230|Drug|Telmisartan 80mg and S-amlodipine 5mg|"Telmisartan 80mg, S-amlodipine 5mg: 1 tablet, oral, once daily, 1day
~over the period I & II(cross-over)"
16142171|NCT01842217|Procedure|FES-PET|
16142172|NCT01842204|Device|Magnetic field therapy device|Therapy device for 1 week.
16142173|NCT01842204|Device|Non magnetic field therapy device.|Non-active device for 1 week.
16142174|NCT01842191|Dietary Supplement|Fish Oil|Patients received 4g/day Omega Rx capsules (Dr. Sears zone diet) containing 0.8 g EPA and 1.6 g DHA and excipient (glycerin, water purified, tocopherol, sunflower oil and titanium dioxide), during 12 months.
16142175|NCT01842191|Dietary Supplement|Placebo|Orally, 4 Capsules per day, (glycerin, water purified, tocopherol, sunflower oil and titanium dioxide), during 12 months.
16142176|NCT01842178|Procedure|scratching|"Endometrial Injury
~Done between 18-24 days prior to embryo transfer cycle.
~Using transfer catheter.
~Introduction of the same to the uterine fundus.
~Systematic scrapping of the four uterine walls, lengthwise.
~Performed by a skilled doctor.
~Subsequent ultrasound control."
16142177|NCT01842165|Drug|Intravenous injection of 177Lu-octreotate|Treatment will consist of 177Lu-octreotate injections in fixed activities of 7,4 GBq (200 mCi) (±5%) each, given 12 weeks (±1 week) apart, injected intravenously simultaneously with nephroprotective perfusion of an amino acid solution.
16142178|NCT01842139|Biological|basiliximab|Given IV
16142179|NCT01842139|Biological|WT1 126-134 peptide vaccine|Given SC
16142180|NCT01842139|Drug|Montanide ISA 51 VG|Given SC
16142181|NCT01842139|Drug|poly ICLC|Given SC
16142182|NCT01842139|Other|laboratory biomarker analysis|Correlative studies
16142183|NCT01842126|Biological|BG00010 IV|Ascending Doses intravenous (IV) of BG00010
16142184|NCT01842126|Biological|BG00010 SC|Ascending Doses subcutaneous (SC) of BG00010
16142185|NCT01842126|Drug|Placebo IV|Ascending Doses intravenous (IV) of Placebo
16142186|NCT01842126|Drug|Placebo SC|Ascending Doses subcutaneous (SC) of placebo
16142187|NCT01842113|Drug|Rifaximin|Rifaximin 550mg by mouth twice a day
16142188|NCT01842113|Drug|Lactulose|Lactulose 30ml by mouth three times a day
16142189|NCT01842113|Drug|Lactulose Placebo|Lactulose Placebo 30ml three times a day
16142190|NCT01842113|Drug|Rifaximin Placebo|Rifaximin Placebo twice a day
16142191|NCT01842100|Drug|Universal antibiotic prophylaxis|100 mg twice daily for 7 days starting on the day of induced abortion
16142192|NCT01842100|Other|Screen-and-treat|Specific antibiotic treatment was only given if the women was found to have sexually transmitted infection(s) on screening.
16142193|NCT01842087|Other|Control Food|For a period of 2 weeks, participants will consume control foods in addition to their usual diets.
16142194|NCT01842087|Other|Fiber Fortified Food|For a period of 4 weeks, participants will consume food fortified with fiber in addition to their usual diets.
16142195|NCT01842074|Drug|Bortezomib|Pilot study on the efficacy and safety of bortezomib during desensitization before a living kidney donation
16142196|NCT01842061|Behavioral|Active Living Program|
16142197|NCT01842061|Behavioral|Education|
16142198|NCT01842048|Other|Hyperthermia|
16142199|NCT01842048|Radiation|External-beam radiotherapy|
16142200|NCT01842035|Drug|regadenoson|Prior to the implantation of a clinically indicated ICD, the heart rate response to regadenoson will be assessed. Regadenoson will be administered intravenously as a fixed intravenous bolus dose of 400 μg followed by a 5 mL saline flush. Medications (including beta-blockers) will be withheld on the morning of the test. The heart rate and blood pressure will be measured at baseline and every minute after regadenoson bolus for at least 5 minutes and until the heart rate and blood pressure are clearly returning towards baseline.
16142201|NCT01842022|Dietary Supplement|Isomaltulose|Isomaltulose sweetened meal will be given to each of four groups who differ in their glucose tolerance
16142202|NCT01842022|Dietary Supplement|Sucrose|Sucrose sweetened meal will be given to each of four groups who differ in their glucose tolerance
16142203|NCT01842022|Dietary Supplement|Glucose|Glucose sweetened meal will be given to each of four groups who differ in their glucose tolerance
16142204|NCT01842009|Device|High Definition transcranial Direct Current Stimulation|
16142205|NCT01841996|Drug|ME1111 solution|Once a day for 28 days
16142206|NCT01841996|Drug|Vehicle Solution|Once a day for 28 days
16142207|NCT01841983|Other|Be Well Work Well|"The intervention follows principles for integrated approaches to promoting and protecting worker health. It will occur on 4 inpatient units at Massachusetts General Hospital beginning in January 2013, and will continue for 1 year.
~Overall intervention objectives:
~Motivate individual staff members to engage in targeted health and safety behavior changes;
~build awareness of ergonomic and safety hazards and of opportunities for healthy dietary choices and physical activity;
~facilitate unit-level norms supportive of breaks, safe patient handling, and targeted health and safety behaviors; and
~promote co-worker and supervisor support for targeted health and safety behaviors."
16142208|NCT01841970|Device|HET Bipolar System|The HET Bipolar System is used to treat hemorrhoids by bipolar ligation of the superior hemorrhoidal blood supply.
16142209|NCT01841957|Procedure|ISBCS|same-day cataract surgery
16142210|NCT01841957|Procedure|DSBCS|bilateral surgery delayed by 1-3 weeks amongst eyes
16142211|NCT01841944|Drug|Pikasol|Pikasol®, 3 capsules (1.8 g EPA+DHA)/day
16142212|NCT01841944|Other|Corn oil|Corn oil (56% linoleic acid, 32% oleic acid, 10% palmitic acid), unchanged and according to the manufacturer
16142213|NCT01841931|Drug|Buprenorphine/Naloxone|Sublingual buprenorphine/naloxone taken in a 3 day induction, with a final daily dose (up to 32 mg depending on the subject) taken daily, as prescribed by the study psychiatrist. Subjects will continue buprenorphine for study duration (6 months).
16142214|NCT01841918|Biological|Avian Flu Vaccine|
16142215|NCT01841905|Other|Observational Study|Observational Study
16142216|NCT01841892|Behavioral|Community Therapeutic Workplace|Participants will be enrolled in Phase 1 training for 4 months, and will then be offered to apply for employment with collaborating community employers.
16142387|NCT01840579|Biological|Ipilimumab 1 mg/kg|Administered as an IV infusion on Day 1 of every other 21-day cycle (every 42 days)
16142217|NCT01841879|Behavioral|Intervention Program|"Receives an integrated tobacco control and occupational health (OH) intervention (The Healthy, Safe, and Tobacco-Free Worksites program) aimed at promoting tobacco cessation among workers and supporting the adoption, implementation, and enforcement of tobacco control policies.
~Through six health education events at the worksites, blue-collar workers (who face dual health risks through their exposures to occupational hazards and their high rates of tobacco use) will gain the knowledge, skills, and social support needed to quit tobacco use.
~Simultaneously, management will receive OH and tobacco policy consultations to help build a healthy and safe work environment, where workers' hazardous exposures are reduced."
16142218|NCT01841879|Behavioral|Delayed Intervention|Receives abbreviated 2-month delayed intervention designed to provide employees with knowledge and skills to quit tobacco after final data collection time point, as well as one non-tobacco event in between data collection points.
16142219|NCT01841866|Other|LMA removal|
16142220|NCT01841853|Behavioral|Senior meetings|The intervention will be led by professionals such as a registered occupational therapist, a nurse, a physical therapist, and a social worker. The intervention will comprise four weekly meetings in small groups (4-6 participants) in addition to an individual follow-up home visit two to three weeks after the last senior meeting. To use groups involve the possibility of peer education where participants in a person-centeredness perspective are seen as experts on their own situation and learn from each other. The relationship between the personnel and the participants in the senior meetings can be described as a partnership. Respect for the participant and his/her values, and that the participant gets an opportunity to maintain and develop their own power over their own everyday activities will be essential in the meeting.
16142221|NCT01841840|Other|Low-Frequency Passive Vibration|10 minute session of passive vibration set to a frequency of 25Hz and a high amplitude exposed to the legs
16142222|NCT01841840|Other|High-Frequency Pasive Vibration|10 minute session of passive vibration set to a frequency of 40Hz and a low amplitude exposed to the legs
16142223|NCT01841827|Drug|Cilostazol|
16142224|NCT01841827|Drug|Placebo|
16142225|NCT01841814|Radiation|Bone densitometry.|
16142226|NCT01841801|Device|Thermal Adhesive Patch|
16142227|NCT01841801|Device|Marketed Thermal Adhesive Patch|
16142228|NCT01841801|Device|Placebo Patch|
16142229|NCT01841788|Device|Thermal Adhesion Patch|
16142230|NCT01841788|Device|Marketed Thermal Adhesion Patch|
16142231|NCT01841788|Device|Placebo Patch|
16142232|NCT01841775|Drug|interferon α 2b + ribavirin|"interferon α 2b: 3.000.000 IU SUBQ 3 times / wk for 24 weeks
~ribavirin 250 mg: 15mg/kg/day,ORALLY twice a day for 24 weeks"
16142233|NCT01841762|Drug|Macitentan|Macitentan tablet, dose of 10 mg, once daily
16142234|NCT01841749|Procedure|sentinel node biopsy and mastectomy|sentinel node biopsy and mastectomy
16142235|NCT01841736|Other|Laboratory Biomarker Analysis|Correlative studies
16142236|NCT01841736|Drug|Pazopanib Hydrochloride|Given PO
16142237|NCT01841736|Other|Placebo Administration|Given PO
16142238|NCT01841736|Other|Quality-of-Life Assessment|Ancillary studies
16142239|NCT01841723|Drug|Ibrutinib|Given PO
16142240|NCT01841697|Drug|Omarigliptin|Omarigliptin (MK-3102) 25 mg oral capsule once a week for 24 weeks
16142241|NCT01841697|Drug|Sitagliptin|Sitagliptin 100 mg oral tablet once a day for 24 weeks
16142242|NCT01841697|Drug|Placebo to omarigliptin|Placebo to omarigliptin 25 mg oral capsule once a week for 24 weeks
16142243|NCT01841697|Drug|Placebo to Sitagliptin|Placebo to sitagliptin 100 mg oral tablet once a day for 24 weeks
16142244|NCT01841697|Drug|Open-label Metformin|Metformin oral tablet(s) - total daily dose of ≥1500 mg, once or twice a day
16142245|NCT01841697|Drug|Open-label Glimepiride|Glimepiride oral tablet(s) - total daily dose of 1 to 6 mg once a day as rescue therapy
16142246|NCT01841684|Drug|Anacetrapib|100 mg tablet orally, once daily for 12 weeks
16142247|NCT01841684|Drug|Placebo|Placebo for anacetrapib orally, once daily for 12 weeks
16142248|NCT01841671|Biological|IPV|Blood samples for poliovirus neutralizing antibodies to be obtained as follows: Group 1 at weeks 8, 16, 28 and 29; Group 2 and 3 at 8, 24, 28 and 29. Stool samples for poliovirus cuantification, for all groups, to be obtained at weeks 28, 29, 30, 31, 32.
16142249|NCT01841671|Biological|bOPV|As indicated
16142250|NCT01841671|Biological|mOPV type 2|Administered at 28 weeks of age to all study participants
16142251|NCT01841671|Biological|Rotarix|Administered at 8 and 16 weeks to all study participants accepting to recive this vaccine
16142252|NCT01841658|Dietary Supplement|Folic acid|Participants will be instructed to consume 2 tablets per day, a total of 800 micrograms folic acid. To facilitate compliance, participants will be instructed in the use of a compliance calendar and will receive frequent telephone and 'text' reminders from project staff. Additionally, compliance will be determined by return pill count.
16142253|NCT01841645|Dietary Supplement|CLA depletion-repletion|
16142254|NCT01841632|Drug|MultiStem|
16142255|NCT01841619|Drug|IVIg|All enrolled subjects will receive IVIg treatment following the protocol that proved to be efficacious in the treatment of patients with autoimmune blistering diseases as well as some patients with CLE. The drug will be administered at 500 mg/kg/day on consecutive days up to a total of 2 g/kg/month for 3 months in the Institute for Clinical and Translational Science (ICTS) at University of California, Irvine. After 3 months of treatment, IVIg will be discontinued and the subjects will be monitored for additional 6 months for a possible relapse. In the case of relapse, which is expected to occur in <25% subjects, the subjects will be re-treated by the standard protocol.
16142256|NCT01841606|Drug|Ondansetron|4mg of IV ondansetron
16142257|NCT01841606|Other|Normal saline|10mL of IV normal saline
16142258|NCT01841593|Drug|Raltegravir|Isentress 400mg tablet taken twice daily
16142259|NCT01841593|Drug|Amlodipine|generic amlodipine 5mg tablets (Accord healthcare Limited, UK)
16142260|NCT01841567|Device|Mepilex border post. op|
16142261|NCT01841567|Device|Mepilex border post op|
16142262|NCT01841554|Device|Cardioband|
16142263|NCT01841541|Behavioral|Referral of presumptive of TB cases by informal providers|Training of informal providers to effectively refer TB suspects in the community to the primary health care system
16142388|NCT01840579|Drug|Etoposide 100 mg/m^2|Administered as an IV infusion on Days 1, 2, and 3 of each 21-day cycle
16142264|NCT01841528|Other|fresh embryo transfer|rFSH/GnRH antagonist will be administered for ovarian stimulation. Oocyte pick-up will be performed when at least two follicles ≥18mm. Two fresh embryos will be transferred at Day 3. Luteal phase support will last 2 weeks for all subjects in this group. Two weeks after embryo transfer, serum HCG will be measured to determine pregnant or not. If biochemical pregnancy is achieved, luteal phase support will be continued to 10 weeks gestation. Pregnancy complications and final outcome will be followed up till 6 weeks after delivery.
16142265|NCT01841528|Other|frozen-thawed embryo transfer|rFSH/GnRH antagonist will be administered for ovarian stimulation. Oocyte pick-up will be performed when at least two follicles ≥18mm. All embryos will be vitrified in fresh cycle, and at least 2 embryos should be frozen at Day 3. Two months later, two thawed Day 3 embryos will be transferred with HRT (hormone replacement therapy) prepared endometrium. Luteal phase support will last 2 weeks for all subjects in this group. Two weeks after embryo transfer, serum HCG will be measured to determine pregnant or not. If biochemical pregnancy is achieved, luteal phase support will be continued to 10 weeks gestation. Pregnancy complications and final outcome will be followed up till 6 weeks after delivery.
16142266|NCT01841515|Drug|Desmopressin administration|
16142267|NCT01841502|Drug|Paroxetine|paroxetine 20 mg once daily
16142268|NCT01841502|Drug|telaprevir|telaprevir 1125 mg twice daily
16142269|NCT01841489|Drug|Treatment A|1600 mg GS-9973 (Formulation 1)
16142270|NCT01841489|Drug|Treatment B|1600 mg GS-9973 (Formulation 1) plus 20 mg omeprazole
16142271|NCT01841489|Drug|Treatment C|1600 mg GS-9973 (Formulation 1) plus 40 mg famotidine
16142272|NCT01841489|Drug|Treatment D|1600 mg GS-9973 (Formulation 2)
16142273|NCT01841489|Drug|Treatment E|1600 mg GS-9973 (Formulation 2) plus 20 mg omeprazole
16142274|NCT01841489|Drug|Treatment F|1600 mg GS-9973 (Formulation 2) plus 40 mg famotidine
16142275|NCT01841489|Drug|Treatment G|1600 mg GS-9973 (Reference formulation)
16142276|NCT01841489|Drug|Treatment H|1600 mg GS-9973 (Formulation 1 or Formulation 2, based on results from Part A)
16142277|NCT01841489|Drug|Treatment I|An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily
16142278|NCT01841489|Drug|Treatment J|An alternate dose of the chosen formulation from Part A up to 1200 mg administered twice-daily
16142279|NCT01841476|Drug|POL6326|
16142280|NCT01841463|Drug|P1446A-05|- In the 'Dose escalation' phase patients will be co-administered P1446A-05 (150, 250, 350 mg qd) & vemurafenib (720, 960 mg bid) in a cohort of 3 to 6 patients on a 28-day cycle, until the occurrence of disease progression or unacceptable toxicity. The next higher dose during the dose escalation phase will depend upon demonstrated safety in the previous dose group. The max tolerated dose (MTD) of P1446A-05 & vemurafenib co-administered will be determined. In the 'Extension' phase, 60 patients with BRAF V600E/K mutations (40 patients naïve to selective BRAF inhibitor therapy, & 20 progressing on selective BRAF inhibitor therapy) will be treated at the MTD on a 28-day cycle, until the occurrence of disease progression or unacceptable toxicity to determine efficacy of the co-administration. Additionally, there will be a cohort of 10 patients who consent for mandatory serial tumor biopsy samples & undergo 'Monotherapy' for 14 days with P1446A-05 at the MTD of the co-administration.
16142281|NCT01841463|Drug|Vemurafenib (Zelboraf®)|"In the 'Dose escalation' phase patients will be co-administered P1446A-05 (150, 250, 350 mg qd) and vemurafenib (720, 960 mg bid) in a cohort of 3 to 6 patients on a 28-day cycle, until the occurrence of disease progression or unacceptable toxicity. Escalation to the next higher dose during the dose escalation phase will depend upon demonstrated safety in the previous dose group. The maximum tolerated dose (MTD) of P1446A-05 and vemurafenib co-administered will be determined.
~In the 'Extension' phase, 60 patients with BRAF V600E/K mutations (40 patients naïve to selective BRAF inhibitor therapy, and 20 progressing on selective BRAF inhibitor therapy) will be treated at the MTD on a 28-day cycle
~Additionally, there will be a cohort of 10 patients who consent for mandatory serial tumor biopsy samples and undergo 'Monotherapy' for 14 days with P1446A-05 at the MTD of the co-administration."
16142284|NCT01841437|Device|iStent|
16142285|NCT01841424|Behavioral|Dietary counseling. Maintain a food diary.|The dietary intervention will be conducted by a registered dietician once. The dietary guidelines for study participants will be similar to those for gestational diabetes including 18 to 24 kcal/kg diet with 40% carbohydrates, 30% protein, 30% fat. No participant will be given a diet that is less than 2,000 kcal per day. Study subjects will record a food diary and to bring it to prenatal visits. Study subjects will limit intake of high calorie dense and acellular processed foods to 1-2 times per week if at all and to increase total percentage of fruits and vegetables to 5-9 items per day.
16142286|NCT01841411|Drug|N-Acetyl cysteine|N-Acetyl cysteine is a pharmaceutical drug and nutritional supplement,it is a derivative of the natural amino acid cysteine, from which it differs by virtue of the introduction of an acetyl group on the nitrogen atom of the amino terminal.It is used mainly as a mucolytic and in management of paracetamol overdose. It has been observed that N-acetyl cysteine has shown good properties in terms of combating bacterial infections. In particular, it has been observed that NAC presents good activity in terms of inhibiting bacterial adhesion and in dissolving the biofilm matrix.
16142287|NCT01841411|Drug|Metronidazole + N-Acetyl cysteine|Metronidazole is an antibiotic effective against anaerobic bacteria and certain parasites.It can be used in treatment of vaginal infections such as trichomoniasis and bacterial vaginosis N-Acetyl cysteine is a pharmaceutical drug and nutritional supplement, It is used mainly as a mucolytic and in management of paracetamol overdose. It has been observed that N-acetyl cysteine has antibacterial and antibiofilm activities
16142288|NCT01841411|Drug|metronidazole|Metronidazole is an antibiotic effective against anaerobic bacteria and certain parasites.It can be used in treatment of vaginal infections such as trichomoniasis and bacterial vaginosis in treatment of bacterial vaginosis, it can be used in treatment of bacterial vaginosis either in a dose of 500 mg twice daily or 250 mg three times daily for seven days
16142289|NCT01841398|Behavioral|Multimedia Lifestyle Improvement|"Goal setting to improve diet, physical activity or smoking behaviours
~Regular health messaging related to the participant's goal, sent by email or text messaging, based on participant preference."
16142290|NCT01841398|Behavioral|Usual Care|Participant will be refered to SAHARA study website to get information on healthy lifestyle and to get regular update for the course of follow-up.
16142291|NCT01841385|Other|Pilates method|Therapeutic intervention in the Pilates method has two regular weekly sessions for 12 weeks, totaling 24 sessions. For the protocol of Pilates exercises, exercises on soil and equipment, with gradual progression of the load.
16142292|NCT01841372|Other|Second Life|Second Life is an online virtual reality environment.
16142293|NCT01841372|Behavioral|Group Phone Conference Call|
16142294|NCT01841359|Drug|Pramlintide|See description above (arm description).
16142295|NCT01841346|Procedure|Procedure: PCI|
16142296|NCT01841333|Drug|PF-04449913|100mg given orally
16142297|NCT01841320|Other|Integrated methadone and antiretroviral therapy (iMART) clinic|
16142298|NCT01841307|Drug|Cromolyn Sodium|
16142299|NCT01841294|Drug|Intravenous Lidocaine|Lidocaine infusion: 1.5 mg/kg bolus on 10 minutes (maximum 150 mg) followed by 1.5 mg/kg/h
16142300|NCT01841294|Drug|Normal saline infusion|Normal saline infusion: 1.5 mg/kg bolus on 10 minutes (maximum 150 mg) followed by 1.5 mg/kg/h
16142301|NCT01841281|Drug|L-Arginine|L-arginine tablets containing 1 g of elemental L-arginine (1204 mg of L-arginine HCL) developed by Jarrow Formulas in Los Angeles.
16142302|NCT01841281|Drug|Placebo|Matching placebo tablets do not contain L-arginine. Placebo tablets were manufactured by Jarrow Formulas and contain cellulose and other excipients.
16142303|NCT01841255|Device|Mouthpiece (Umox)|Device used to perform preoxygenation in the operating room context
16142304|NCT01841255|Device|facemask|
16142305|NCT01841242|Drug|alcoholic povidone iodine|
16142306|NCT01841242|Drug|alcoholic chlorhexidine|
16142307|NCT01841216|Device|Lower Body Exercises with and without resistance|lower body exercises with and without resistance designed to activate the gluteal/hip musculature
16142308|NCT01841177|Drug|Milrinone|Milrinone is a potent selective phosphodiesterase (PDE) type III inhibitor which stimulates myocardial function (inotropy), causes peripheral vasodilatation (afterload reduction) and improves myocardial relaxation (lusitropy).
16142309|NCT01841164|Drug|Montelukast|
16142310|NCT01841164|Drug|Placebo for montelukast|Sugar pills manufactured to mimic Singulair
16142311|NCT01841164|Other|Inhaled leukotriene E4|Inhalation challenge with aerosolized GMP-grade LTE4 (Cayman Chemical Company 1180 East Ellsworth Road, Ann Arbor, Michigan 48108,USA)
16142312|NCT01841151|Behavioral|SCP training|
16142313|NCT01841151|Behavioral|Live Z-score training|
16142314|NCT01841151|Behavioral|WM training|
16142315|NCT01841125|Drug|escitalopram|escitalopram 15mg, QD(once a day), Oral medication, 24weeks
16142316|NCT01841125|Drug|Placebo|placebo 15mg, QD(once a day), Oral medication
16142317|NCT01841112|Drug|BI 409306|tablet
16142318|NCT01841112|Drug|BI 409306|tablet
16142319|NCT01841112|Drug|BI 409306|tablet
16142320|NCT01841112|Drug|BI 409306|tablet
16142321|NCT01841112|Drug|placebo|placebo tablet
16142322|NCT01841112|Drug|placebo|placebo tablet
16142323|NCT01841112|Drug|BI 409306|tablet
16142324|NCT01841099|Drug|Mesalamine|Mesalamine granules
16142325|NCT01841099|Drug|Placebo granules|Provided by Ferring Pharma
16142326|NCT01841086|Drug|Anplag|Sarpogrelate HCl 300mg once a day or 100mg three times a day
16142327|NCT01841086|Drug|UI03SPG300CT|Sarpogrelate HCl 300mg once a day or 100mg three times a day
16142328|NCT01841073|Dietary Supplement|Inulin|Subjects will have 4 dietary counselling sessions in the first 9 weeks of the study with a goal to lose 5% of their body weight by week 9. They will be asked to maintain their weight loss until week 18.
16142329|NCT01841073|Dietary Supplement|Cellulose|Subjects will have 4 dietary counselling sessions in the first 9 weeks of the study with a goal to lose 5% of their body weight by week 9. They will be asked to maintain their weight loss until week 18.
16142330|NCT01841073|Dietary Supplement|Inulin|Subject will take inulin for 6 weeks in total with no other change to their diet or lifestyle.
16142331|NCT01841073|Dietary Supplement|Cellulose|Subject will take cellulose for 6 weeks in total with no other change to their diet or lifestyle.
16142332|NCT01841073|Dietary Supplement|Inulin|"Subject will take inulin for 6 weeks in total with no other change to their diet or lifestyle.
~Subject will wear a Continuous Glucose Monitor for 4 x 5 days during the study."
16142333|NCT01841073|Dietary Supplement|Cellulose|"Subject will take cellulose for 6 weeks in total with no other change to their diet or lifestyle.
~Subject will wear a Continuous Glucose Monitor for 4 x 5 days during the study."
16142334|NCT01841060|Procedure|Percutaneous radiofrequency ablation (RFA)|Computed tomography (CT) was used to treat tumors under general anesthesia. Thoracic epidural anesthesia was administered in case of contraindication to general anesthesia mostly due to poor respiratory function. All patients were treated with the same multitine electrodes (LeVeen; Boston Scientific, Nattick. MA) measuring 3, 3.5, or 4 cm in diameter and at least 10 mm larger than the diameter of the target tumor. Multiple overlapping ablations were performed, when needed, in different parts of the tumor in order to cover the entire volume.
16142335|NCT01841047|Radiation|Radiotherapy|Evaluation of the efficacy of the combination with radio-surgery helical tomotherapy irradiation to a dose of radiation of 54 Gy in patients with retroperitoneal liposarcoma of operable
16142336|NCT01841034|Drug|Conceptio EA|The patients are included during a consultation whether it is with a clinician or a biologist of the Center. It is suggested in routine in the service, to all the patients consulting for a problem of infertility and presenting pathological spermatic data, taking the food complement Conceptio. At the patients wishing to take this complement it will be suggested participating in this study. This complement is usually bought by the patient, within the framework of this study this one will be gracefully supplied. The follow-up of the patient will contain no examination and no anybody visit besides the usually realized follow-up.
16142337|NCT01841021|Drug|Brentuximab vedotin|Brentuximab vedotin will be given by intravenous infusion (into a vein) on Day 1 of every 21 day cycle.
16142338|NCT01841008|Drug|Protopic|Topical treatment (tacrolimus or placebo) will be delivered to the patient by the hospital pharmacy and should be applied twice per week (3 or 4 days apart) for 24 weeks.
16142339|NCT01841008|Drug|Placebo : Diprobase|Topical treatment (tacrolimus or placebo) will be delivered to the patient by the hospital pharmacy and should be applied twice per week (3 or 4 days apart) for 24 weeks.
16142772|NCT01837446|Drug|2% morphine solution|
16142340|NCT01840995|Procedure|ultrasonographic measurement of optic nerve sheath diameter|A thick layer of gel is applied on the upper closed eyelid. The linear 13- to 6-MHz ultrasound probe is then placed in the gel, without exerting pressure on the eye. Two measurements are taken for each optic nerve: one in the transverse plane, with the probe being horizontal, and one in the sagittal plane, with the probe being vertical. The final ONSD is the mean of these measurements.
16142341|NCT01840982|Dietary Supplement|Mixed grain 1|All test foods contained 50 g available carbohydrate from the test food products. A glass of 200 ml water was served together with the clinical trial food, and the participants were instructed to ingest the breakfast with 15 min.
16142342|NCT01840982|Dietary Supplement|Mixed grain 2|All test foods contained 50 g available carbohydrate from the test food products. A glass of 200 ml water was served together with the clinical trial food, and the participants were instructed to ingest the breakfast with 15 min.
16142343|NCT01840982|Dietary Supplement|White rice|All test foods contained 50 g available carbohydrate from the test food products. A glass of 200 ml water was served together with the clinical trial food, and the participants were instructed to ingest the breakfast with 15 min.
16142344|NCT01840982|Other|Glucose solution|All test foods contained 50 g available carbohydrate from the test food products.
16142345|NCT01840956|Biological|HAVG|HAVG is implanted into patients' arm.
16142346|NCT01840943|Drug|CAELYX|CAELYX 50 mg per square meter will be administered intravenously on Day 1 of each cycle as: 60 to 90-minute infusion to the participants not undergoing pharmacokinetic (PK) evaluation and 90-minute infusion to the participants undergoing for PK evaluation.
16142347|NCT01840943|Drug|Topotecan HCl|Topotecan 1.25 mg per square meter per day will be administered, intravenously for 30-minutes duration, on Day 1 to Day 5 of each cycle.
16142348|NCT01840891|Behavioral|Lactose H2 breath test (LH2BT)|Prevalence of lactose intolerance stated with a positive LH2BT and/or a positive LTT in RTRs with chronic norovirus infection.
16142349|NCT01840865|Device|brain stimulation|oscillating direct current brain stimulation
16142350|NCT01840865|Device|no stimulation|sham Stimulation
16142351|NCT01840839|Device|brain stimulation|
16142352|NCT01840839|Device|Sham Stimulation|
16142353|NCT01840826|Other|RED-D Care Management|The Case Management intervention will continue for 12 weeks post-discharge (from the index admission).
16142354|NCT01840813|Drug|Misoprostol|It is a synthetic prostaglandin (PgE1 analogue)used as a uterotonic substance.
16142355|NCT01840813|Drug|Normal saline|It is a placebo group
16142356|NCT01840800|Drug|Ropivacaine|
16142357|NCT01840800|Drug|placebo|
16142358|NCT01840787|Device|balafilcon A (8.6)|To be worn for 8 hours in one eye, and its comfort compared to another lens on another eye.
16142359|NCT01840787|Device|balafilcon A (8.3)|To be worn for 8 hours in one eye, and its comfort compared to another lens on another eye.
16142360|NCT01840787|Device|senofilcon A|To be worn for 8 hours in one eye, and its comfort compared to another lens on another eye.
16142361|NCT01840774|Drug|Low-dose pain medication (Ketalar) and saline placebo|
16142362|NCT01840761|Drug|herbal drug|
16142363|NCT01840761|Drug|placebo|
16142364|NCT01840735|Drug|GS-5737|
16142365|NCT01840735|Drug|Placebo|
16142366|NCT01840722|Other|MI-based HIV Risk Reduction|As the only MI-based intervention identified by the CDC as a best-practice model, the MI-HIV intervention has been shown to demonstrate positive outcomes for criminal justice-involved women randomly assigned to the intervention group for risky sexual activity and drug use with sustained behaviors through 9 months.
16142367|NCT01840709|Behavioral|Psychotherapy|Psychoanalytic brief group psychotherapy once a week for 20 consecutive weeks
16142368|NCT01840696|Drug|Regadenoson|Vasodilator stress testing
16142369|NCT01840683|Device|H.E.L.P. therapy (H.E.L.P. Plasmat Futura System)|
16142370|NCT01840670|Drug|Rapid fluid load test|The test will be performed by infusing 250-300 mL/m2 Body Surface Area of 6% hydroxyethyl starch 6% 130/0.4 (VoluvenR) in 30 minutes
16142371|NCT01840644|Other|Walking on treadmill, different velocities and incline|Walking on treadmill twice, with one week interval in each session the child will walk in different velocities and incline
16142372|NCT01840631|Behavioral|Nutritional Counseling|Participants enrolled will be randomized into group nutrition counseling or individual nutrition counseling classes, for a total of 6 classes. Classes will meet one time a month. Classes will cover topics including nutrition, exercise, and behavior to promote healthy eating.
16142373|NCT01840618|Device|Nasal Continuous positive airway pressure (CPAP)|We will initiate treatment of OSA with CPAP for 3 months in PCOS adolescents with moderate to severe OSA. Compliance will be defined as the average number of hours for which CPAP was used per night over the 12-wk treatment period. Adherence with CPAP will be defined as CPAP use ≥4 hours daily. The primary outcome variable will be insulin sensitivity measured as change in GIR. Changes in cardio metabolic variables after CPAP treatment will be expressed as a percentage of the corresponding baseline values.
16142374|NCT01840605|Drug|Bepotastine besilate|Two TAU-284 5mg tablets and one ketotifen fumarate dry syrup 1g placebo will be taken orally twice a day
16142375|NCT01840605|Drug|ketotifen fumarate|Two TAU-284 5 mg placebo tablets and one ketotifen fumarate dry syrup 1g will be taken orally twice a day
16142376|NCT01840592|Drug|Sorafenib|
16142377|NCT01840592|Drug|Doxorubicin|
16142378|NCT01840579|Biological|Pembrolizumab 2 mg/kg|Administered as an intravenous (IV) infusion on Day 1 of Cycle 1 (28 days), Cycle 2 (14 days), and Cycle 3 (14 days)
16142379|NCT01840579|Biological|Pembrolizumab 10 mg/kg|Administered as an IV infusion on Day 1 of Cycle 1 (28 days), Cycle 2 (14 days), and Cycle 3 (14 days)
16142380|NCT01840579|Biological|Pembrolizumab 200 mg|Administered as an IV infusion on Day 1 of each 21-day cycle
16142381|NCT01840579|Drug|Cisplatin 75 mg/m^2|Administered as an IV infusion on Day 1 of each 21-day cycle
16142382|NCT01840579|Drug|Pemetrexed 500 mg/m^2|Administered as an IV infusion on Day 1 of each 21-day cycle
16142383|NCT01840579|Drug|Carboplatin AUC 5 mg/mL/min|Administered as an IV infusion on Day 1 of each 21-day cycle
16142384|NCT01840579|Drug|Carboplatin AUC 6 mg/mL/min|Administered as an IV infusion on Day 1 of each 21-day cycle
16142385|NCT01840579|Drug|Paclitaxel 200 mg/m^2|Administered as an IV infusion on Day 1 of each 21-day cycle
16142773|NCT01837446|Drug|Magnesium aluminum hydroxide|
16142389|NCT01840579|Drug|G-CSF (pegfilgrastim) 3.6 mg|Administered as a subcutaneous injection on Day 4 of Cycle 1
16142390|NCT01840566|Drug|Carmustine|
16142391|NCT01840566|Drug|Etoposide|
16142392|NCT01840566|Drug|Cytarabine|
16142393|NCT01840566|Drug|Melphalan|
16142394|NCT01840566|Biological|Pegfilgrastim|
16142395|NCT01840566|Biological|19-28z T CELLS|
16142396|NCT01840566|Procedure|Autologous Stem Cell Transplantation|
16142397|NCT01840553|Drug|oral sodium phosphate tablets|
16142398|NCT01840553|Drug|polyethylene glycol|
16142399|NCT01840540|Drug|Arterial infusion of autologous mesenchymal stem cells|
16142400|NCT01840501|Drug|JNJ-42721458 (single dose)|JNJ-42721458 will be administered subcutaneously (an injection under the skin) as single doses, starting from 0.1 mg.
16142401|NCT01840501|Drug|JNJ-42721458 (multiple doses)|JNJ-42721458 will be administered subcutaneously (an injection under the skin) once daily, starting with a dose of 5.0 mg.
16142402|NCT01840501|Drug|Placebo (single dose)|Matching placebo will be administered subcutaneously (an injection under the skin) as a single dose in Part 1.
16142403|NCT01840501|Drug|Placebo (multiple doses)|Matching placebo will be administered subcutaneously (an injection under the skin) once daily for 10 days in Part 2.
16142404|NCT01840488|Drug|Irosustat (BN83495)|"Three parts (A, B & C) open label, multiple cohort, dose escalation study with once daily administration of irosustat at 1, 5, 20, 40 and 80 mg. Patients treated in any cohort were not allowed to escalate to higher doses or be enrolled in another dosing cohort.
~Part A - Single oral daily dose for 7 days, Part B - Repeated oral daily dose for 28 days and Part C - Repeated oral daily administration until disease progression."
16142405|NCT01840449|Drug|Somatuline Autogel® 60, 90 or 120 mg|
16142406|NCT01840436|Device|MUCIPLIQ|MUCIPLIQ is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day.
16142407|NCT01840436|Device|Placebo|Placebo is applied by mouthwash, for 2 to 3 minutes before being spat out, twice a day.
16142408|NCT01840423|Drug|ODM-104|ODM-104
16142409|NCT01840423|Drug|Placebo|Placebo
16142410|NCT01840423|Drug|Entacapone|entacapone + levodopa/carbidopa
16142411|NCT01840423|Drug|levodopa/carbidopa|entacapone + levodopa/carbidopa
16142412|NCT01840410|Drug|Ranibizumab|Ranibizumab 0.5mg/0.5mL was administered intravitreally to the participant.
16142413|NCT01840410|Other|Sham control|The sham vial did not contain active drug (empty sterile vial). The sham injection was an imitation of an intravitreal injection using an injection syringe without a needle touching the eye.
16142414|NCT01840384|Dietary Supplement|Multi-micronutrients|
16142415|NCT01840384|Dietary Supplement|Maltodextrin and Lactose|
16142416|NCT01840371|Drug|Conventional sedation|"Propofol Meperidine : 25 mg IV just before procedure
~IV bolus of 1 mg/kg for sedation induction,
~Infusion of 60 mcg/min/kg for maintenance of sedation
~Additional bolus dose of 10mg as needed for adequate sedation"
16142417|NCT01840371|Drug|Experimental sedation|"Fentanyl
~IV bolus of 1 µg/kg for sedation induction
~Additional bolus dose of 0.5 µg/kg as needed for adequate pain control Propofol
~IV bolus of 0.4 mg/kg for sedation induction
~Infusion of 30 µg/min/kg for maintenance of sedation
~Additional bolus dose of 10mg as needed for adequate depth of sedation"
16142418|NCT01840358|Other|Observation of hypoglycemias frequency 3 days before and after pump initiation|
16142419|NCT01840345|Drug|N-acetyl-l-cysteine|1200 mg BID x 4 weeks
16142420|NCT01840332|Drug|L-thyroxin|Low dose of L-thyroxin (50 microg/day) will be used during 4 weeks. If TSH is < 30 after 4 weeks the study continues up to 6 weeks.
16142421|NCT01840306|Other|Biomarker Analysis|
16142422|NCT01840267|Device|ultrasonographic measurement of optic nerve sheath diameter|A thick layer of gel is applied on the upper closed eyelid. The linear 13- to 6-MHz ultrasound probe is then placed in the gel, without exerting pressure on the eye. Two measurements are taken for each optic nerve: one in the transverse plane, with the probe being horizontal, and one in the sagittal plane, with the probe being vertical. The final ONSD is the mean of these measurements.
16142423|NCT01840254|Drug|dexmedetomidine|
16142424|NCT01840254|Drug|normal saline|
16142425|NCT01840241|Drug|sodium bicarbonate|BIVON group were received 0.5 mmol/kg of sodium bicarbonate for 1hours after induction of anesthesia and following 0.15 mmol/kg of sodium bicarbonate during the operation.
16142426|NCT01840241|Drug|normal saline|
16142427|NCT01840228|Drug|Micronized progesterone suppository|
16142428|NCT01840189|Other|Cortef|Treatment A is oral hydrocortisone replacement ( Cortef 5 mg) administered according to weight-adjusted doses for 2 months
16142429|NCT01840189|Other|Solu-cortef|"Treatment B is continuous subcutaneous hydrocortisone infusion with the initial standard dose of 10mg/m2/24hrs. Body surface area will be calculated according to the nomogram from the formula of Du Bois and Du Bois.
~This part of the study will take 2 months."
16142430|NCT01840176|Procedure|McCall culdoplasty|The modified McCall Culdoplasty procedure is a relatively simple procedure that is performed after removal of the uterus and cervix from the apex of the vagina wherein the angles of the vagina are attached to their respective uterosacral ligament and the cul-de-sac is surgically obliterated for support postoperatively. This is done with a single 0-vicryl suture. There will be no additional interventions applied during the hysterectomy aside from the McCall culdoplasty.
16142431|NCT01840163|Other|Static version of CanSORT tool|
16142432|NCT01840163|Other|CanSORT Online Tool|
16142433|NCT01840150|Procedure|breath test|Undergo NA-NOSE breath test
16142434|NCT01840150|Other|laboratory biomarker analysis|Correlative studies
16142435|NCT01840137|Other|Baseline Strength Test|A symptom limited submaximal cardiopulmonary exercise test to estimate the subject's exercise capacity.
16142436|NCT01840137|Other|Exercise|Treadmill and muscle exercises.
16142437|NCT01840124|Procedure|Radiofrequency ablation of fibroids|The Acessa device delivers radiofrequency energy to uterine fibroids to destroy fibroid tissue. The patient undergoes a standard laparoscopy of the pelvis. A laparoscopic ultrasound is performed to identify the precise size and location of the fibroids. The Acessa radiofrequency probe is then placed into the fibroid and the radiofrequency energy is delivered. The fibroid tissue is destroyed and the fibroid shrinks down in size to decrease fibroid-related symptoms.
16142438|NCT01840111|Behavioral|Quit Smoking 6 hours|participants will quit smoking 6 hours prior to the cue-exposure sessions
16142439|NCT01840111|Behavioral|Quit Smoking 24 hours|participants will quit smoking 24 hours prior to the fMRI scan
16142440|NCT01840098|Dietary Supplement|low leucine content drink|
16142441|NCT01840098|Dietary Supplement|high leucine content drink|
16142442|NCT01840098|Dietary Supplement|low leucine + HMB drink|
16142443|NCT01840098|Dietary Supplement|Control/carbohydrate|
16142444|NCT01840098|Behavioral|36 hour fasting|
16142445|NCT01840085|Drug|0.03% DSC127 topical gel|
16142446|NCT01840072|Other|Active antihypertensive treatment|Initial antihypertensive treatment with angiotensin-converting enzyme inhibitors (Enalapril) and/or calcium channel blockers as second line medication; and/or diuretics as third line medications. Based on patients' baseline BP level, the first-line medication (intravenous Enalapril) can be used alone, or in combination with second-line medication (calcium channel blocker), and third-line medication (diuretics) to achieve the target systolic BP lowering by 10% to 25% within the first 24 hours after randomization and to achieve systolic BP below 140 mm Hg and diastolic BP below 90 mm Hg and maintain this BP level afterwards during the hospitalization.
16142447|NCT01840059|Device|Renal sympathetic denervation|A fit for purpose radiofrequency catheter is guided to the renal artery using fluoroscopy. This is connected to an external RF generator. RF energy is applied through the catheter to the renal artery wall with the goal of disrupting the sympathetic nerves which run in the adventitia
16142448|NCT01840046|Drug|Interleukin-2|"The patient will receive 4 cycles of recombinant interleukin 2 (aldesleukin, Proleukin ®) subcutaneously according to the following dosing schedule:
~5 to 7 days (Monday to Friday) in weeks 1, 3, 6 and 9.
~The dosage is as follows:
~S1: 1.5 mille-International unit / day (D1 to D5), S3, S6 and S9: 3 mille-International unit /Jour (D1 to D5)."
16142449|NCT01840033|Device|group Piccnut|Vessels echography will be systematically repeated at 3 months and 12 months for thrombosis research. Follow-up visit will be held at 1,3,6,9 and 12 months. At every step, major and minor complications will be noted by the investigators.
16142450|NCT01840033|Device|Tunnelled nutritional central catheter|After consent, patients will be randomised to PICC Line (group A) or tunnelled nutritional central catheter with cuff (group B). Duration of inclusion will be 24 months. After randomisation, patients will have catheter inserted by a competent radiologist following an echography. Radiologist will have to answer a questionnaire and doctors will note any catheter-related complications. After that, vessels echography will be systematically repeated at 3 months and 12 months for thrombosis research. Follow-up visit will be held at 1,3,6,9 and 12 months. At every step, major and minor complications will be noted by the investigators.
16142451|NCT01840020|Procedure|Gastric bypass|Surgical procedure in which the stomach is transected high on the body. The resulting small proximal gastric pouch is joined to any parts of the small intestine by an end-to-side surgical anastomosis.
16142452|NCT01840020|Procedure|gastric sleeve|Sleeve gastrectomy, a surgical procedure in which the stomach is reduced to about 25% of its original size, by surgical removal of a large portion of the stomach, following the major curve. The open edges are then attached together (often with surgical staples) to form a sleeve or tube with a banana shape.
16142453|NCT01840007|Drug|Metformin Group|"The chosen posology is 2540 mg/day of metformin-base so 3 tablets/day of Glucophage ® 1000.
~Patients should take 3 tablets/day at the rate of 1tablet in morning, noon and evening to favor the absorbtion and reduce the risk of gastrointestinal intolerance. In case of missed dose, patients will be allowed to take 2 tablets on the next grip. The drug will be presented in its officinale form of Glucophage ® 1000 with specifications indicated in the Vidal dictionary. It will be provided each month, to patient, 3 boxes of 30 tablets of Glucophage ® 1000. The patient will be asked to rate each day, on a calendar, the number of tablets of Glucophage ® 1000 effectively taken. It will also ask to the patient to bring back used boxes of Glucophage ® 1000 to count any tablets not taken."
16142454|NCT01839994|Radiation|CF-CRT combined with BT or SBRT boost.|CF-CRT to the prostate and SV (IM risk group) or to the prostate, SV and LN (high risk group) to the TD of 50 Gy, 2.0 Gy d fx, 5 days a week over the period of 5 weeks AND A. Two 10 Gy fractions of HDR BT 1-7 d. before external beam radiotherapy and one 1-7 d. after external beam radiotherapy OR B. Two stereotactic body radiotherapy (SBRT) fractions of 10 Gy to the prostate (CTV boost) delivered with dynamic SBRT technique (IMRT or Rapid Arc). First and second fraction of SBRT boost is scheduled 1-7 d. before and 1-7 d. after the start of conventionally fractionated radiotherapy, respectively.
16142455|NCT01839994|Radiation|CF-CRT alone|Conventionally fractionated EB-CRT (IMRT or Rapid Arc) to the TD of 50 Gy, followed by a boost to the prostate (26 or 28 Gy in 2.0 Gy per fraction 5 days a week over the period of 2.5 weeks) to the total dose of 76 or 78 Gy (intermediate or high risk group of patients, respectively).of 50 Gy in 2.0 Gy per fraction, 5 days a week over the period of 5 weeks, followed by a boost to the prostate (26 or 28 Gy in 2.0 Gy per fraction 5 days a week over the period of 2.5 weeks) to the total dose of 76 or 78 Gy (intermediate or high risk group of patients, respectively).
16142456|NCT01839994|Drug|Hormonal treatment (neoadjuvant androgen deprivation)|Hormonal treatment: three months of neoadjuvant androgen deprivation (MAB -maximal androgen blockade) in all patients. Long-term (3 years) of adjuvant hormonotherapy (LHRH agonists only) in high risk patients.
16142457|NCT01839981|Drug|6,8-bis(benzylthio)octanoic acid|Given IV
16142458|NCT01839968|Other|Ex vivo addition of normal platelet rich plasma to prasugrel-treated platelet rich plasma|
16142459|NCT01839955|Drug|erlotinib hydrochloride|"Dose Escalation Group:
~Begins day 1: given 150mg daily, orally
~Extension Group:
~Begins Day 1: 150mg daily, orally"
16142460|NCT01839955|Drug|quinacrine dihydrochloride - Escalation dose|Begins Day 8: Loading dose (first cycle only) 50mg three times daily for 7 days followed by 21 days of 50mg maintenance dose. Level -1: Loading dose (50mg three times daily for 7 days), maintenance dose (50mg every other day for three weeks). Level 1 [starting dose]: Loading dose (50mg three times daily for 7 days), maintenance dose (50mg daily for three weeks). Level 2: Loading dose (100mg three times daily for 7 days), maintenance dose (100mg every other day for three weeks). Level 3: Loading dose (150mg three times daily for 7 days), maintenance dose (200mg every other day for three weeks). Level 4: Loading dose (200mg three times daily for 7 days), maintenance dose (400mg every other day for three weeks). Subsequent patient cohort(s) will be enrolled depending on the safety and tolerability of subjects
16142461|NCT01839955|Other|laboratory biomarker analysis|Correlative studies
16142462|NCT01839955|Other|pharmacological study|Correlative studies
16142774|NCT01837446|Drug|2% viscous lidocaine|
16142775|NCT01837446|Drug|Diphenhydramine|
16142463|NCT01839955|Drug|quinacrine dihydrochloride - Extension dose|Participants will be treated at recommended dose from expansion group to confirm tolerability and evaluate early response
16142464|NCT01839942|Procedure|hernia gap closure|type of gap closure during laparoscopic repair of a ventral hernia: none, extracorporal, intracorporal
16142465|NCT01839942|Procedure|extracorporal suturing of gap|ventral hernia gap is sutured extracorporally
16142466|NCT01839929|Drug|Prograf|oral
16142467|NCT01839929|Drug|Advagraf|oral
16142468|NCT01839916|Biological|therapeutic allogeneic lymphocytes|Given IV
16142469|NCT01839916|Other|laboratory biomarker analysis|Correlative studies
16142470|NCT01839903|Other|EDIS|Changes made to EDIS system to improve tracking and treatment of smoking in the ED
16142471|NCT01839903|Other|Care as usual|Care as usual in the ED will be tracked
16142472|NCT01839890|Device|Bare metal Stent plus Paclitaxel Balloon|After the permeabilization of the clinical event responsible artery with conventional therapy (including the insertion of a conventional metal stent and once by the interventional cardiologist gives good final result), patients will be randomized in a 1:1 ratio
16142473|NCT01839890|Device|Bare metal Stent|After the permeabilization of the clinical event responsible artery with conventional therapy a conventional metal stent will be inserted. Once by the interventional cardiologist gives good final result), patients will be randomized in a 1:1 ratio
16142474|NCT01839877|Drug|HIA DEBIRI + systemic FOLFOX|
16142475|NCT01839864|Behavioral|Promotora plus standard physical screening exam , hemoglobin A1c levels, lipid panels, fasting glucose, height, weight, BMI, Complete Blood Count|Promotora services plus the standard care model will be provided for one randomly assigned cohort of patients meeting the inclusion criteria while the other cohort will receive the standard care model only
16142476|NCT01839851|Drug|Treatment with any inhaled corticosteroid|Use of any inhaled corticosteroid (daily frequency and dose will be registered)
16142477|NCT01839851|Drug|Treatment with any intranasal glucocorticoid|Use of any inhaled intranasal glucocorticoid (daily dose and frequency will be registered)
16142478|NCT01839838|Radiation|Proton Therapy|
16142479|NCT01839825|Device|QuietCare|
16142480|NCT01839812|Drug|Cosyntropin|A cosyntropin stimulation test is administered to each patient at 3 time points during the study to evaluate adrenal response.
16142481|NCT01839799|Drug|Gemcitabine|1000mg/m2 IV over 30 to 100 minutes, day 1, 8, 15
16142482|NCT01839799|Drug|Abraxane|125 mg/m2 IV over 30 minutes, day 1, 8, 15
16142483|NCT01839799|Drug|FOLFIRINOX|Irinotecan 180 mg/m2 Day 1 Oxaliplatin 85 mg/m2 Day 1 5-FU 400 mg/m2 bolus with Leucovorin 200 mg/m2 over 2h, Day 1, then 5-FU 2400 mg/m2 over 46h. Four cycles, if tolerated
16142484|NCT01839799|Radiation|Chemoradiation|
16142485|NCT01839773|Drug|Paclitaxel|Oral administration on day 1,8,15 of 4-week cycle until progression, unacceptable toxicity or withdrawal of informed concent
16142486|NCT01839773|Drug|Paclitaxel|Premedication, IV infusion on day 1 of 3-week cycle until progression, unacceptable toxicity or withdrawal of informed concent
16142487|NCT01839747|Procedure|PET-MRI|Imaging
16142488|NCT01839747|Procedure|PET-CT|Imaging
16142489|NCT01839734|Drug|Lubiprostone|Lubiprostone 24 mcg by mouth (PO) once-daily
16142490|NCT01839721|Drug|Bifilact®|placebo, standard dose 1.3 billion twice a day, high dose 10 billion three time a day
16142491|NCT01839721|Other|placebo|
16142492|NCT01839708|Behavioral|Lifestyle Counseling|The intervention will determine the differential outcomes of reading generic materials versus viewing custom DVDs containing targeted health information and discussions with MI-trained moderators on weight gain prevention.
16142494|NCT01839669|Device|Foot Orthoses Only|patients wear foot orthoses as a treatment condition - no further therapy
16142495|NCT01839669|Procedure|Foot Orthoses and Eccentric Exercise|patients wear foot orthoses and they perform an additional home-based eccentric training program for the M. tibialis posterior
16142496|NCT01839669|Device|Sham Foot Orthoses|patient wear sham foot orthoses (control condition)
16142497|NCT01839656|Drug|nusinersen|Administered by intrathecal (IT) injection
16142498|NCT01839643|Drug|Meloxicam 2.4 g|2.4 g in Vaginal Ring
16142499|NCT01839643|Drug|Meloxicam 3.0 g|3.0 g in Vaginal Ring
16142500|NCT01839630|Drug|Sorafenib (Nexavar, BAY43-9006)|sorafenib treatment (including dose, duration, modification) and TACE procedure are decided by the investigator
16142501|NCT01839617|Dietary Supplement|Early parenteral nutrition|
16142502|NCT01839617|Dietary Supplement|Late parenteral nutrition|
16142503|NCT01839604|Drug|AZD9150|Intravenous infusion over 3 hours.
16142504|NCT01839591|Device|catheter ALAIR|Catheter ALAIR Radiofrequency 65°
16142505|NCT01839578|Drug|Anticoagulation to prevent clotting of the extracorporeal circuit. (regional citrate anticoagulation)|"Anticoagulation to prevent clotting of the extracorporeal circuit. Unfractionated heparin and regional citrate anticoagulation will be compared.
~Ci-Ca protocole for MultiFiltrate® CRRT machine :
~4% trisodium citrate solution
~Calcium chloride solution (100 mmol/L)
~Dialysate flow rate: 35 ml/kg/h
~Blood flow rate: adjusted to maintain a ratio blood flow rate / dialysate flow rate of 3
~Citrate infusion titrated to maintain postfilter ionized calcium between 0.25 and 0.35 mmol/L.
~Calcium chloride infusion titrated to maintain systemic ionized calcium between 1.12 and 1.2 mmol/L.
~Blood flow adapted to the acid-base status"
16142506|NCT01839578|Drug|Anticoagulation to prevent clotting of the extracorporeal circuit (Unfractionated heparin)|"Anticoagulation to prevent clotting of the extracorporeal circuit. Unfractionated heparin and regional citrate anticoagulation will be compared.
~Continuous infusion of unfractionated heparin: starting infusion rate at 600 IU/h then adjusted to maintain partial thromboplastin time at 1-1.4 times the normal value.
~Standard dialysate for CRRT : Prismasol® K2 solution
~Dialysate flow rate: 35 ml/kg/h
~Blood flow rate: adjusted to maintain a ratio blood flow rate / dialysate flow rate of"
16142507|NCT01839565|Device|Quadrilateral Surface Plate|Patients with acetabular fracture surgically treated using the Quadrilateral Surface Plate
16142508|NCT01839552|Drug|Fentanyl Citrate Nasal Spray (FCNS)|
16142509|NCT01839539|Biological|dendritic and cytokine-induced killer cells|
16142980|NCT01835899|Drug|BI 1015550|low dose 1 powder for oral solution
16142510|NCT01839526|Drug|Iohexol|Evaluations of renal and cardiac function are standard-of-care in young patients with Fabry disease. This study uses the more precise iGFR measurement of renal function. No investigational drug will be administered in this study for the treatment of Fabry disease.
16142511|NCT01839500|Drug|Trastuzumab|Trastuzumab administered in accordance with routine care practice.
16142512|NCT01839487|Drug|PEGPH20|PEGPH20 will be administered as per the dose and schedule specified in the respective arms.
16142513|NCT01839487|Drug|Nab-paclitaxel|Nab-paclitaxel will be administered as per the dose and schedule specified in the respective arms.
16142514|NCT01839487|Drug|Gemcitabine|Gemcitabine will be administered as per the dose and schedule specified in the respective arms.
16142515|NCT01839487|Drug|Dexamethasone|Dexamethasone will be administered as per the dose and schedule specified in the respective arms.
16142516|NCT01839487|Drug|Enoxaparin|Enoxaparin will be administered as per the dose and schedule specified in the respective arms.
16142517|NCT01839474|Device|CPAP|Appropriately sized nasal prongs will be selected for the patient, gently applied ensuring a tight seal, and securely fastened. The CPAP machine will be turned on to deliver a pressure of 5 cm H2O in the inspiratory limb of the system. Patients will be allowed to be in the position of most comfort, preferably with mouth closed to maintain pressure in the circuit.
16142518|NCT01839448|Biological|Post-partum oral glucose tolerance test|All patients will have an oral glucose tolerance test at 4 to 12 weeks after the end of pregnancy. Study representatives will contact patients by phone to remind them of the necessity of this test, and its importance for their health.
16142519|NCT01839435|Procedure|outpatient surgery|
16142520|NCT01839422|Behavioral|Memory assessment|Cognitive assessment : Neuropsycological tests, learning sessions of new stimuli.
16142521|NCT01839422|Other|Brain imaging examination MRI|Brain imaging examination : Structural and functional MRI to compare differences between each sample.
16142522|NCT01839409|Behavioral|vestibular stimulation|Physical activity and vestibular stimulation will be used in order to improve circadian rhythms
16142524|NCT01839383|Other|different dialysate calcium concentration|
16142525|NCT01839370|Device|Closed Loop with Pramlintide|A closed-loop automated insulin management system (Adaptive Insulin Meal Supervisor- AIMS) for meals utilizing continuous glucose monitoring (CGM)and subcutaneous insulin pump and a standard pramlintide therapy will be compared to a standard pramlintide therapy alone to control glucose levels in individuals with type 1 diabetes. DiAs is controlled by the subject, with assistance from the study personnel as needed.
16142526|NCT01839357|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Rivaroxaban 20 mg orally once daily for 6 weeks; subjects with severe to moderate renal impairment (ie, CrCl of 15 to 49 mL/min, inclusive) will receive the adjusted dose of 15 mg orally once daily for 6 weeks in the study.
16142527|NCT01839344|Dietary Supplement|Quercetin|Quercetin 250 mg capsules; oral single dose of 2000 mg
16142528|NCT01839344|Drug|Acarbose|Acarbose 100 mg tablet; oral single dose of 100 mg
16142529|NCT01839344|Drug|placebo|An oral single dose of a solid, colored empty capsule.
16142530|NCT01839331|Drug|Low Dose Ampion|4 mL Ampion
16142531|NCT01839331|Drug|High Dose Ampion|10 mL Ampion 10mL
16142532|NCT01839331|Drug|Placebo Low Dose 4 mL|4 mL Placebo
16142533|NCT01839331|Drug|Placebo 10 mL|Placebo 10 mL
16142534|NCT01839318|Device|Nelfilcon A contact lenses|
16142535|NCT01839318|Device|Omafilcon A contact lenses|
16142536|NCT01839318|Device|Etafilcon A contact lenses|
16142537|NCT01839305|Other|Hydrotherapy|Hydrotherapy, monitored by physical therapists, performed in groups of up to 10 volunteers, for 45 min per session, twice a week, for 16 weeks
16142538|NCT01839292|Device|uncovered D-type stent insertion|
16142539|NCT01839292|Device|double-layered ComVi stent insertion|
16142540|NCT01839279|Drug|Tizanidine|
16142541|NCT01839279|Drug|Placebo|
16142542|NCT01839279|Drug|Moxifloxacin|
16142543|NCT01839253|Drug|b-blocker(Atenolol)|
16142544|NCT01839253|Drug|ACE inhibitor(Enapril)|
16142545|NCT01839253|Other|control|
16142546|NCT01839240|Drug|azacitidine|Given IV or SC
16142547|NCT01839240|Drug|cytarabine|Given IV
16142548|NCT01839240|Drug|mitoxantrone hydrochloride|Given IV
16142549|NCT01839240|Other|laboratory biomarker analysis|Correlative studies
16142550|NCT01839227|Other|Neurologic and neuropsychologic tests|"Cognitive functioning was assessed with the following test: Korean Mini-Mental State Examination (K-MMSE) and visuomotor test of D-LOTCA battery.
~Regional cerebral oxygen saturation was continuously monitored using the INVOS 5100 (somatics,Troy, MI) with bifrontal placement of two sensors before the induction of the anesthesia until the end of operation.
~Baseline rSO2 was defined as the average saturation value over a 1 min period before induction of general anesthesia, beginning approximately 3 min after the sensors were applied in supine position. After the induction, baseline prone rSO2 was defined over a 5min period after the change of position.
~There is no intervention were made according to rSO2 values. Physiologic variables including BIS, PaCO2,PaO2, glucose, electrolyte, hematocrit, HR, MAP, and nasopharyngeal temperature were measured every 1 hours during the surgery."
16142551|NCT01839214|Drug|VB-201 160mg|
16142552|NCT01839214|Drug|Placebo|
16142553|NCT01839201|Other|control|No psychological intervention
16142554|NCT01839201|Other|suggestion|In the suggestion group patients received suggestions evoking their images of favourite place at the time of narcosis induction.
16142555|NCT01839201|Other|dreamfilm|In the dreamfilm group patients worked out the dreamfilm plan using a favourite place technique one day prior to surgery. At the induction of anesthesia the series of images prepared by suggestions was evoked.
16142556|NCT01839188|Biological|PR5I|Hexavalent PR5I vaccine (DTaP-HB-IPV-Hib = Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed [DTaP], Hepatitis B [HB; Recombinant DNA], Inactivated Poliovirus [IPV], and Haemophilus influenzae type b [Hib] conjugate vaccine [adsorbed]) at 0.5 mL for IM injection (left upper thigh) at 2 and 6 months of age.
16142987|NCT01835821|Device|prosthetic crowns|prosthetic crowns
16142557|NCT01839188|Biological|Pediacel®|Pentavalent Pediacel® vaccine (DTaP-IPV-Hib = Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed [DTaP], Inactivated Poliovirus [IPV], and Haemophilus influenzae type b [Hib] conjugate vaccine [adsorbed]) at 0.5 mL for IM injection (left upper thigh) at 4 months of age.
16142558|NCT01839188|Biological|NeisVac-C®|Meningococcal group C (MCC) polysaccharide conjugate vaccine (adsorbed) at 0.5 mL for IM injection (right upper thigh) at 2 and 4 months of age.
16142559|NCT01839188|Biological|RotaTeq®|Human-bovine rotavirus reassortants (live) vaccine 2 mL oral administration at 2, 4 and 6 months of age. RotaTeq® administered prior to any other vaccine administration to avoid having the infant participants spit up the RotaTeq® when crying.
16142560|NCT01839188|Biological|Prevenar 13®|Pneumococcal polysaccharide conjugate vaccine [PCV; 13-valent, adsorbed]) at 0.5 mL for IM injection (right upper thigh) at 2 and 4 months of age.
16142561|NCT01839175|Biological|Hexavalent vaccine|0.5 mL intramuscular injection at 2, 3 and 4 months of age (primary series) 0.5 mL intramuscular injection at 12 or 13 months of age (booster)
16142562|NCT01839175|Biological|NeisVac-C|0.5 mL intramuscular injection at 2 and 4 months of age
16142563|NCT01839175|Biological|Prevenar 13|0.5 mL intramuscular injection at 2 and 4 months of age (primary series) 0.5 mL intramuscular injection at 13 months of age (booster)
16142564|NCT01839175|Biological|RotaTeq|2 mL oral administration at 2, 3 and 4 months
16142565|NCT01839175|Biological|Nimenrix|0.5 mL intramuscular injection at 12 months
16142566|NCT01839175|Biological|M-M-RVAXPRO|0.5 mL intramuscular or subcutaneous injection at 13 months of age
16142567|NCT01839162|Procedure|Coronary angiography|Diagnostic coronary angiography
16142568|NCT01839162|Procedure|PCI|Percutaneous coronary intervention
16142569|NCT01839162|Procedure|Right approach|Right transradial access
16142570|NCT01839162|Procedure|Left approach|Left transradial access
16142571|NCT01839149|Drug|TI-001|TI-001 is intranasal oxytocin
16142572|NCT01839149|Drug|Placebo|
16142573|NCT01839136|Procedure|Intrauterine transfer of gametes|
16142574|NCT01839136|Procedure|Intrauterine transfer of embryos|
16142575|NCT01839123|Device|Prosthetic Suction or Pin Socket|Conventional prosthetic socket utilizing non-vacuum suspension to secure the residual limb to the prosthesis. Non-vacuum suspension includes pin/lock suspension and suction suspension.
16142576|NCT01839123|Device|Prosthetic LimbLogic Vacuum Socket|Prosthetic socket that incorporates conventional vacuum suspension using the commercially available LimbLogic vacuum pump
16142577|NCT01839110|Drug|Ranolazine|Ranolazine at 500mg by mouth twice per day and after two weeks will increase to 1000mg by mouth twice per day and continue for a total of 26 weeks.
16142578|NCT01839110|Drug|Placebo|Placebo by mouth twice per day for a total of 26 weeks.
16142579|NCT01839097|Drug|Belinostat|"Belinostat will be administered by intravenous infusion once daily for up to 5 days depending on the dose cohort as follows:
~Cohort 1: belinostat 1000 mg/m2 IV on Day 1
~Cohort 2: belinostat 1000 mg/m2 IV on Day 1-2
~Cohort 3: belinostat 1000 mg/m2 IV on Day 1-3
~Cohort 4: belinostat 1000 mg/m2 IV on Day 1-4
~Cohort 5: belinostat 1000 mg/m2 IV on Day 1-5"
16142580|NCT01839097|Drug|CHOP|"Cyclophosphamide - 750 mg/m2 - IV - Day 1
~Vincristine - 1.4 mg/m2 - IV - Day 1
~Doxorubicin - 50mg/m2 - IV - Day 1
~Prednisone 100mg PO - On Day 1 Prednisone will be administered after chemotherapy part of CHOP, and on Day 2-5 after belinostat."
16142581|NCT01839084|Drug|Xenon|general anaesthesia with xenon 60% in oxygen (FiO2=0.4)
16142582|NCT01839084|Drug|Isoflurane|general anesthesia with isoflurane 1.2% in 40% oxygen/medical air
16142583|NCT01839071|Procedure|biopsy|
16142584|NCT01839058|Other|Esophageal Manometry|Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus.
16142585|NCT01839032|Drug|Vinorelbine cisplatin radiotherapy|"During the induction period, patients received chemotherapy for two 3-week cycles. Bolus intravenous vinorelbine 25 mg/m², was administered on day 1, then cisplatin 80 mg/m² was administered over 1-hour infusion. Vinorelbine 60 mg/m² was also administered on day 8.
~Patients with objective response (OR) or no change (NC) continued the concomitant period (CP) including two additional 3-week cycles of radio chemotherapy (vinorelvine 20 mg D1 D3 D5 Cisplatin 80 mg/m² 66 Gy)."
16142586|NCT01839019|Drug|ODM-102|Single dose escalation
16142587|NCT01839019|Drug|Placebo for ODM-102|Single dose escalation
16142588|NCT01839006|Procedure|dismembered pyeloplasty|Using a flank approach, as the patient was placed in the lateral decubitus position, and an anterior subcostal incision was made. The narrow segment of UPJ was identified and resected, and then the proximal edge of the ureter was spatulated to allow a wide anastomosis between the ureter and the most dependent part of the renal pelvis. The extent of renal pelvis reduction was decided by the surgeon.
16142589|NCT01838993|Drug|Lidocaine inhalation|Lidocaine inhalation before intubation
16142590|NCT01838993|Drug|Placebo|
16142591|NCT01838980|Device|Motus GI Clean-Up Device|
16142592|NCT01838967|Drug|C - V - C+V|Drug will be administered to according to C - V - C+V sequence for 3 period.
16142593|NCT01838967|Drug|C - C+V - V|Drug will be administered to according to C - C+V - V sequence for 3 period.
16142594|NCT01838967|Drug|V - C - C+V|Drug will be administered to according to V - C - C+V sequence for 3 period.
16142595|NCT01838967|Drug|V - C+V - C|Drug will be administered to according to V - C+V - C sequence for 3 period.
16142596|NCT01838967|Drug|C+V - C - V|Drug will be administered to according to C+V - C - V sequence for 3 period.
16142597|NCT01838967|Drug|C+V - V - C|Drug will be administered to according to C+V - V - C sequence for 3 period.
16142598|NCT01838954|Device|Short-wave diathermy|Device operating at a frequency of 27.12 MHz in continuous mode with an effective nominal output of 400 W in the patient circuit.
16142599|NCT01838941|Drug|Betaine|"Betaine will be given orally (mixed with food or dissolved in water, juice, milk, or formula) or through gastrostomy tube as follows:
~6 g/day in children < 30 kg, in 3 divided doses (2 g at meal time)
~12 g/day in children > 30 kg, in 4 divided doses (3 g at meal time and bed time)."
16142600|NCT01838928|Drug|Bupivacaine|
16143032|NCT01835405|Device|Sutures (Prolene)|
16143037|NCT01835353|Drug|Prasugrel 100mg loading dose|
16142601|NCT01838915|Dietary Supplement|Prebiotics+Glutamine|"Prebiotics are nondigestible food ingredients, generally oligosaccharides, that modify intestinal microbiota balance by stimulating the growth of beneficial bacteria.
~Glutamine is a non-essential amino acid that can be metabolized by epithelial cells, enhancing barrier function."
16142602|NCT01838915|Dietary Supplement|Placebo|Maltodextrin, 20 g.
16142603|NCT01838902|Drug|DHA-PPQ|Participants will receive a 3 day course of DHA-PPQ
16142604|NCT01838902|Drug|PQ (0.75)|Participants will receive a single dose of PQ at 0.75mg base/kg body weight
16142605|NCT01838902|Drug|PQ (0.4)|Participants will receive a single dose of PQ at 0.4mg base/kg body weight
16142606|NCT01838902|Drug|PQ (0.2)|Participants will receive a single dose of PQ at 0.2mg base/kg body weight
16142607|NCT01838889|Behavioral|Culturally adapted psychological intervention (Positive Health Programme)|This study will evaluate the efficacy of a group psychological intervention (PHP) based on the principles of Cognitive Behaviour Therapy in treating depression in postpartum women.
16142608|NCT01838876|Drug|Cariprazine|Cariprazine capsules 0.5 mg, 1.0 mg, and 1.5 mg; Cariprazine doses 1.5, 3.0, or 4.5 mg/day (d); patients will be titrated to a starting dose of 3.0 mg/d. Patients can stay on 3.0 mg/d or the dose can be adjusted to 1.5 mg or 4.5 mg based on investigator's judgment of response and tolerability. Oral administration.
16142609|NCT01838876|Drug|Antidepressant Therapy (ADT)|ADT such as citalopram, escitalopram, fluoxetine, sertraline, paroxetine, vilazodone, venlafaxine, desvenlafaxine, duloxetine or bupropion prescribed in accordance with its respective FDA approved package insert for each drug
16142610|NCT01838863|Biological|Type AB plasma|The plasma is thawed and administered to subjects in the experimental (plasma) arm.
16142611|NCT01838863|Drug|Crystalloid fluid (standard of care for resuscitation)|Normal saline will be give to subjects in the standard arm as the current standard of care for an initial resuscitation fluid
16142612|NCT01838850|Drug|CS8635 20/5/12.5mg and placebo|"Run-in period: Coated, Oral tablet containing Olmesartan medoxomil(OM)-Hydrochlorothiazide(HCTZ) 20-12.5mg, given once a day.
~Double-blind period: Coated, Oral tablet containing Olmesartan medoxomil(OM)-Amlodipine (AML)-Hydrochlorothiazide(HCTZ) 20-5-12.5mg, oral placebo tablet. All tablets are given once a day.
~Open-label period: Coated, Oral tablet containing Olmesartan medoxomil(OM)-Amlodipine(AML)-Hydrochlorothiazide(HCTZ) 40-5-12.5mg, given once a day."
16142613|NCT01838850|Drug|Olmetec® Plus 20/12.5mg and placebo|"Run-in period: Coated, Oral tablet containing Olmesartan medoxomil(OM)-Hydrochlorothiazide(HCTZ) 20-12.5mg, given once a day.
~Double-blind period: Coated, Oral tablet containing Olmesartan medoxomil(OM)-Hydrochlorothiazide(HCTZ) 20-12.5mg, oral placebo tablet. All tablets are given once a day.
~Open-label period: Coated, Oral tablet containing Olmesartan medoxomil(OM)-Amlodipine(AML)-Hydrochlorothiazide(HCTZ) 20-5-12.5mg, given once a day."
16142614|NCT01838824|Behavioral|Speed of Processing Training|SPT involves trainer-guided practice of computer-based exercises, including Target Detection (indicating presence or absence of targets, identifying targets, etc.) and Discrimination and Localization (performing same/ different discriminations of targets presented very quickly and followed by a masking pattern) 10, 19, 84. Display speed, ranging from 17 to 500 ms, is the primary manipulation during training, which increases task demands and thus demands on PS itself.
16142615|NCT01838811|Behavioral|Speed of Process Training|SPT involves trainer-guided practice of computer-based exercises, including Target Detection (indicating presence or absence of targets, identifying targets, etc.) and Discrimination and Localization (performing same/ different discriminations of targets presented very quickly and followed by a masking pattern) 10, 19, 84. Display speed, ranging from 17 to 500 ms, is the primary manipulation during training, which increases task demands and thus demands on PS itself. These training tasks are tailored to each individual's ability by the trainer.
16142616|NCT01838798|Other|Baseline activities|Initial consent procedures and baseline data collection.
16142617|NCT01838798|Other|Clinical interview with a psychologist|"Clinical interview with a psychologist.
~This interview with a psychologist will take place after patient consent procedures, and at least 2 days after discontinuation of sedation, and before leaving the ICU. This interview will include:
~An inventory of peritraumatic distress symptoms
~A questionnaire on peritraumatic dissociative experiences
~An assessment of related, potential impacts
~The HADS questionnaire"
16142618|NCT01838798|Other|Telephone interview 2 months after ICU discharge|"At 2 months after leaving the ICU, a psychologist will contact the patient with questions regarding his/her representation of hospitalization. This implies the following:
~Questionnaires assessing memories and stressors (Questionnaires ICUMT, and ICU-SEQ
~An assessment of psychological trauma
~An assessment of potential impacts"
16142619|NCT01838798|Other|Clinical interview with a psychologist|"At 4 months after ICU discharge, the patient has a clinical interview during which a psychologist will:
~assess cognitive functions
~evaluate clinical symptoms of depression
~assess quality of life
~assess symptoms of post traumatic stress"
16142620|NCT01838785|Drug|18F-DTBZ AV-133|
16142621|NCT01838772|Drug|Pegylated-Interferon and Ribavirin|This is an open-label, single arm demonstration study. Intervention consists in treatment with Pegylated-interferon (Peg-Intron®, 1.5 microgr/kg/week, as subcutaneous injection) and ribavirin (Rebetol®, weight-based dosing, 2-daily doses) for 48 weeks, or 24 weeks for patients with genotype 2 and 3, moderate liver fibrosis, and rapid virological response.
16142622|NCT01838733|Other|Observational study|
16142623|NCT01838720|Procedure|zero ischemia laparoscopic RFA assisted TE|
16142624|NCT01838720|Procedure|ischemia|conventional laparoscopic partial nephrectomy
16142625|NCT01838707|Drug|0.125% Bupivacaine HCL @ 4-5 ml/h|
16142626|NCT01838707|Drug|0.125% Bupivacaine HCL , Morphine sulphate @ 3 mg 3-5 ml/h|
16142627|NCT01838707|Drug|0.125% Bupivacaine, Fentanyl 100 mic @ 3-5 ml/h|
16142628|NCT01838694|Biological|Ala-Cpn10|
16142629|NCT01838694|Drug|Placebo|
16142630|NCT01838681|Drug|Placebo|Once daily, tablets, orally
16142631|NCT01838681|Drug|Brexpiprazole|1, 2, or 3 mg/day, once daily dose, tablets, orally. Uptitration in weekly steps from 1 mg/day
16142632|NCT01838681|Drug|ADT|Duloxetine, escitalopram, fluoxetine, paroxetine IR, sertraline, venlafaxine XR; dosing according to label
16142633|NCT01838668|Drug|Placebo|Two placebo capsules orally BID
16142634|NCT01838668|Drug|dimethyl fumarate|Two dimethyl fumarate 120mg capsules orally BID
16142635|NCT01838655|Drug|Nitisinone|Oral dose of 2mg daily for 12 months.
16142636|NCT01838642|Drug|Ponatinib|Ponatinib tablets will be administered orally, continually, once daily at a dose of 30 mg. A cycle of ponatinib is defined as 28 consecutive days starting with the first day of the treatment cycle. Treatment will be administered primarily in an outpatient setting.
16142637|NCT01838616|Drug|Tapentadol Prolonged Release|All participants started with 50 mg tapentadol hydrochloride prolonged release (twice daily). The dose of tapentadol hydrochloride prolonged release will be adjusted in increments of 50 mg to a level that provided adequate analgesia. Titration will be after a minimum of 3 days on a dose. Participants are permitted a maximum dose of 250 mg twice a day (500 mg total daily dose). After titration participants will remain on the stable dose for 9 weeks.
16142638|NCT01838616|Drug|Oxycodone/Naloxone Prolonged Release|All participants start with 10 mg/5 mg oxycodone/naloxone (twice daily). The dose of oxycodone/naloxone may be adjusted in increments of 10mg/ 5 mg oxycodone/naloxone to a level that provide adequate analgesia. Titration will be after a minimum of 3 days on a dose. Participants will be permitted a maximum dose of 50 mg/ 20 mg oxycodone/naloxone twice daily a day (100 mg/40 mg total daily dose). After titration participants will remain on the stable dose for 9 weeks.
16142639|NCT01838603|Other|Qualitative interview|Qualitative interview to sample the patients feelings, experiences and thoughts risen by the treatments in the program
16142640|NCT01838590|Drug|SOF|Sofosbuvir (SOF) 400 mg tablet administered orally once daily
16142641|NCT01838590|Drug|RBV|Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16142642|NCT01838564|Other|Routine Data collection|"Patients assigned to the control arm answered PediQUEST (PQ) surveys at most once a week and at least once a month. PQ-surveys were administered through a tablet computer if patient was at the clinic or ward or over the phone if patient was primarily at home. PQ-survey had 9 age- and respondent- adapted versions.
~Control arm participants reported their satisfaction with the PediQUEST technology twice 4th and 8th PediQUEST administration. These surveys were embedded in PediQUEST."
16142643|NCT01838564|Other|Feedback of patient-reported outcomes|Patients, parents and primary providers received printed reports summarizing patient/parent reported outcomes for last five visits. When child reported moderate-severe distress an email was automatically sent to primary providers (oncologist, nurses and psychosocial clinicians), as well as to the pain and palliative care services.
16142644|NCT01838551|Drug|Levoketoconazole|Levoketoconazole is the 2S,4R- enantiomer derived from racemic ketoconazole
16142645|NCT01838538|Drug|Bevacizumab|
16142646|NCT01838538|Drug|TC:paclitaxel + carboplatin|
16142647|NCT01838499|Biological|MEDI8968|SC injection at baseline, Week 4 and Week 8
16142648|NCT01838499|Biological|Saline|SC injection at baseline, Week 4 and Week 8
16142649|NCT01838486|Procedure|Bladder Thermal Distention|Bladder Thermal Distention (BTD) is an approved procedure in Europe and Israel. Continuous irrigation of the bladder with warm saline with the PelvixTT system. The procedure will be performed on an outpatients basis. The procedure lasts 1 hour.
16142650|NCT01838473|Procedure|Buccal Administration of nicotine|Oral pouch 1g, single dose. One pouch administered over 30 minutes.
16142651|NCT01838473|Procedure|Buccal Administration of nicotine|Oral pouch 1g, single dose. One pouch administered over 30 minutes.
16142652|NCT01838473|Procedure|Buccal Administration of nicotine|Oral pouch 0.5 g, single dose. One pouch administered over 30 minutes.
16142653|NCT01838473|Procedure|Buccal Administration of nicotine|Oral pouch 0.3 g, single dose. One pouch administered over 30 minutes.
16142654|NCT01838460|Drug|sublingual nicotine tablets|6 mg = 3 tablets
16142655|NCT01838460|Other|Smokeless tobacco|Swedish type moist snuff
16142656|NCT01838447|Dietary Supplement|Cholecalciferol|The High Dose group is based on the age-specific UL. These doses were chosen to elevate 25OHD well above 50 nmol/L, while minimizing the risk of vitamin D toxicity (e.g. hypercalcemia, hypercalciuria)
16142657|NCT01838434|Drug|lenalidomide|given PO
16142658|NCT01838434|Drug|idelalisib|given PO
16142659|NCT01838408|Other|Ez2go Complete|EZ2Go Complete
16142660|NCT01838408|Other|LoSo Prep|LoSo Prep ™ Magnesium Citrate plus Bisacodyl Kit Study Arm
16142661|NCT01838395|Drug|Ara-C|IV
16142662|NCT01838395|Drug|BL-8040|SC
16142663|NCT01838382|Device|classic LMA insertion|Classic LMA (cLMA) will be inserted when no response is obtained in the train-of-four stimulation. The fiberoptic view through the LMA, intraoperative complications of the cLMA, any complication during anesthesia emergence will be recorded. The device is examined and noted for the presence of visible blood.
16142664|NCT01838369|Drug|BI-505|
16142665|NCT01838343|Other|Ultrasound|Goal-directed ultrasound using a GE Vscan performed by a critical care fellow trained in ultrasonography.
16142666|NCT01838330|Dietary Supplement|psyllium|15 grams/day for 1 week, followed by 30 grams/day for 4 months
16142667|NCT01838317|Drug|Pioglitazone|
16142668|NCT01838304|Device|Probability ramp control|Decision support software that calculates propofol doses appropriate for age and weight of the patient
16142669|NCT01838304|Device|Monitoring|Manual recording of drug doses determined by CRNA
16142670|NCT01838278|Behavioral|Vojta Physiotherapy Method|Children in the experimental group or Vojta Group, received two weekly sessions of sensory-motor stimulation and two weekly sessions of Vojta Physiotherapy. Sensory motor stimulation and Vojta physiotherapy sessions lasted 50 minutes each. A guidance programme was also given to parents to carry out at home to promote the overall development of the child and teach the necessary Vojta method exercises, these were to be performed four times a day for 20 minutes.
16142671|NCT01838265|Procedure|Transrectal Ultrasound-Guided Biopsy|Active Surveillance Alone (AS). Transrectal Ultrasound-guided biopsies within 6 months of enrollment and at 1 year intervals thereafter (maximum four biopsies).
16142672|NCT01838265|Procedure|MRI Ultrasound Biopsy|MRI-Managed Active Surveillance (MRI-AS). MRI Ultrasound or MRI-guided biopsies within 6 months of enrollment and at 1 year intervals thereafter (maximum four biopsies)
16142673|NCT01838265|Behavioral|Expanded Prostate Cancer index Composite Questionnaire|Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy
16142674|NCT01838265|Behavioral|Short-Form 12 of Health Related Quality of Life Questionnaire|Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy
16143033|NCT01835392|Procedure|Remote Ischemic Preconditioning|Lower limb ischemia/reperfusion cycles
16142675|NCT01838265|Behavioral|Memorial Anxiety Scale for Prostate Cancer|Quality of life questionnaire obtained at Baseline, and at 12, 24 and 36 months after initial biopsy
16142676|NCT01838265|Procedure|Plasma/Serum Sample for biomarkers|Plasma/Serum Sample for biomarkers obtained at Baseline, and at 12, 24 and 36 months after initial biopsy for correlative studies (CTC, fcDNA, SNPs)
16142677|NCT01838265|Procedure|Urine Sample for Biomarkers|Urine Sample for biomarkers obtained at Baseline, and at 12, 24, and 36 months for correlative studies (hypermethylated DNA)
16142678|NCT01838265|Procedure|Blood Tests for Blood Urea Nitrogen and Creatinine|Blood Tests for Blood Urea Nitrogen (BUN) and Creatinine obtained at 0 - 6 months, and at 12, 24, and 36 months from initial biopsy. This is optional, subject may refuse
16142679|NCT01838265|Procedure|Blood Test for Serum PSA|Blood test for Serum PSA obtained at Baseline, at every 6 months up to 36 months from initial biopsy.
16142680|NCT01838252|Procedure|Hyaluronic acid|Hyaluronic acid filler will be injected in to the lower lid, elevating it to a more anatomic position
16142681|NCT01838252|Procedure|Saline|Saline will be injected in to the lower lid, elevating it to a more anatomic position
16142682|NCT01838239|Dietary Supplement|Fish Oil|Ocean Nutrition Fish Oil Capsules containing 1.9 g eicosapentaenoic acid (EPA) and 1.5 g docosahexaenoic acid (DHA)
16142683|NCT01838226|Behavioral|Problem Solving|A group problem-solving intervention, with interval phone calls delivered to check in on goal progress and reinforce group learning. Groups will meet monthly for 6 months, and each patient will be called once between each group session. Each group will consist of 10 patients. Problem-solving teaches patients to overcome internal barriers to healthful behaviors. Problem solving will be combined, at all group sessions, with self-efficacy training, so that patients will be taught simultaneously to overcome both internal and external barriers. Participants will be asked to develop personal goals related to CVD-related behaviors (e.g., smoking and weight reduction).
16142684|NCT01838200|Biological|Bacillus Calmette-Guérin (BCG) vaccine|BCG was to be administered as a single intralesional injection (200 µL volume) on Day 1 at varying doses depending on cohort assignment.
16142685|NCT01838200|Drug|Ipilimumab|Ipilimumab was to be administered as a 90-minute IV infusion at a dose of 3 mg/kg every 3 weeks (± 3 days) on Days 36, 57, 78, and 99.
16142686|NCT01838200|Drug|Isoniazid|Isoniazid was to be administered orally at a dose of 300 mg (3 × 100 mg tablets) every day from Days 29 through 56.
16142689|NCT01838174|Drug|ACTHAR Gel (ACTH)|15 days of daily injections
16142690|NCT01838174|Drug|IV methylprednisolone (steroids)|3 days of intravenous methylprednisolone followed by 11 days of oral taper
16142691|NCT01838161|Behavioral|Part II|Parents will be exposed to an educational video intervention if they are enrolled in this intervention condition.
16142692|NCT01838161|Behavioral|Part III|•video educational
16142693|NCT01838161|Behavioral|Part I|Parental Interviews
16142694|NCT01838135|Device|WheelSeeU Training Program|WheelSeeU sessions will be administered by a peer-trainer (older adult wheelchair user), who will be trained in a 2-day workshop to use social cognitive approaches (i.e. facilitating successful performance of wheelchair skills, learning through observation of peers, positive verbal reinforcement from peers and family members, and re-interpretation of physiological symptoms) to foster the improvement of self-efficacy for wheelchair use. Each WheelSeeU session will be tailored to the individual goals of participants, which will be identified during the start of each session.
16142695|NCT01838109|Dietary Supplement|oral nutritional supplement|
16142696|NCT01838096|Device|THA using 4th generation CoC|
16142697|NCT01838083|Drug|Insulin glargine new formulation HOE901|Pharmaceutical form: solution Route of administration: subcutaneous
16142698|NCT01838057|Device|painPREMIER cohort|Low back pain patients prospectively recruited during the study period and managed with painPREMIER.
16142699|NCT01838057|Other|Control cohort|A matched group of low back pain patients not managed with painPREMIER.
16142700|NCT01838044|Drug|pregabalin and celecoxib|"During the first study period subjects in Arm A will be administered a daily fixed dose of celecoxib 200 mg once daily and pregabalin 150 mg (75 mg BID) for one week (during Week 0) followed by pregabalin 300 mg (150 mg BID) daily for the remaining 4 weeks. During the second study period all subjects will be administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Subjects in Arm B will be initiated on pregabalin 150 mg (75 mg BID) daily for one week, before pregabalin will up titrated to 300 mg (150 mg BID) daily.
~All subjects will complete a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose will be decreased to 150 mg (75 mg BID) daily and subjects will participate in a follow up visit for a final safety assessment."
16142701|NCT01838044|Drug|Placebo and celecoxib|"Subjects in Arm B will be administered a daily fixed dose celecoxib 200 mg and placebo of pregabalin for 5 weeks. During the second study period all subjects will be administered concomitant treatment of a daily fixed dose of celecoxib 200 mg once daily and pregabalin 300 mg (150 mg BID). Subjects in Arm B will be initiated on pregabalin 150 mg (75 mg BID) daily for one week, before pregabalin will up titrated to 300 mg (150 mg BID) daily.
~All subjects will complete a treatment taper (a) after completing the second study period or (b) after premature study discontinuation. During treatment taper, the pregabalin dose will be decreased to 150 mg (75 mg BID) daily and subjects will participate in a follow up visit for a final safety assessment."
16142702|NCT01838031|Other|thyroid screening|The thyroid function and antibody will be measured immediately. The subclinical hypothyroidism will be treated individually.
16142703|NCT01838005|Behavioral|Conditional cash transfer|Eligible women randomized to the intervention group will receive the standard of care plus small and increasing cash payments, on the condition that they attend scheduled clinic visits on time (+/-5days), accept HIV services, deliver in a health facility, and at six weeks postpartum adhere to prescribed infant prophylactic drugs (cotrimoxazole, extended NVP) and provide blood sample for DNA PCR infant early HIV diagnosis.
16142704|NCT01837992|Drug|Primaquine|
16142705|NCT01837992|Drug|delayed primaquine|
16143034|NCT01835392|Other|Control|Sham placement of blood pressure cuff without inflation
16142706|NCT01837979|Procedure|cell-free fetal DNA|cell-free fetal DNA for DBS and maternal serum screening high risk pregnant women. Comparison of multiple Down's syndrome screening tests.
16142707|NCT01837966|Other|Lavender oil|2 drops for aromatherapy
16142708|NCT01837966|Other|Placebo|2 drops unscented mineral oil for aromatherapy
16142709|NCT01837953|Behavioral|Group Psychodynamic Interpersonal Psychotherapy|For those participants randomized to the USH + Group Psychodynamic Interpersonal Psychotherapy (GPIP) condition, this intervention will consist of 16 weekly 90 minute sessions of GPIP. GPIP was developed and empirically tested in a randomized controlled trial (RCT) at our Centre. GPIP will be preceded by an individual pre-group preparation session conducted by a psychologist trained in GPIP to orient the patient to the therapy. Patients are given a rationale for the treatment. Examples of the patient's cyclical relational patterns (CRPs) that may underlie their symptoms are discussed and the patient will be encouraged to work on these in the groups. Therapists will be given a written summary of each patient's CRP.
16142710|NCT01837953|Behavioral|Unguided Self-Help|All participants will first receive 10 weeks of Unguided Self-help. The USH will be based on Dr. Christopher Fairburn's CBT-oriented and evidence based self-help treatment plan for binge eating explained in his book, Overcoming Binge Eating. The USH program follows six steps: (1) Getting Started: Self-monitoring, weekly weighing; (2) Regular Eating: Establishing a pattern of regular eating; (3) Alternatives to Binge Eating: Substituting alternative activities; (4) Problem Solving and Taking Stock: Practicing problem solving and reviewing progress; (5) Dieting and Related Forms of Avoidance: Tackling the three forms of dieting and other forms of avoidance eating; and (6) What Next? Preventing relapse and dealing with other problems.
16142711|NCT01837940|Dietary Supplement|Placebo|Galactooligosaccharide (GOS) and rhamnose in a powder formulation
16142712|NCT01837940|Dietary Supplement|Lactobacillus reuteri DSM 17938|Lactobacillus reuteri DSM17938, Galactooligosaccharide (GOS), rhamnose in a powder formulation
16142713|NCT01837927|Drug|NVA237|Once daily for 52 weeks
16142714|NCT01837927|Drug|Tiotropium Respimat®|Once daily for 52 weeks
16142715|NCT01837914|Procedure|Maxillary expansion|
16142716|NCT01837914|Procedure|Adenotonsillectomy|
16142717|NCT01837901|Device|Transcorneal electrostimulation|
16142718|NCT01837888|Device|WheelSee Training Program|WheelSee sessions will be administered by a peer-trainer, who will be trained in a 2-day workshop to use social cognitive approaches (i.e. facilitating successful performance of wheelchair skills, learning through observation of peers, positive verbal reinforcement from peers and family members, and re-interpretation of physiological symptoms) to foster the improvement of self-efficacy for wheelchair use. Each WheelSee session will be tailored to the individual goals of participants, which will be identified during the start of each WheelSee session.
16142719|NCT01837875|Behavioral|Chronic Disease Self-Management Program (CDSMP)|The Chronic Disease Self-Management Program (CDSMP) is a 2.5 hour workshop given weekly for six weeks. People with different chronic health problems attend together and support one another in making positive changes in their health. Workshops are facilitated by two trained leaders, one or both of whom are non-health professionals with a chronic disease themselves. It is the process in which the program is taught that makes it effective. Classes are highly participative, and mutual support builds the participants' confidence in their ability to manage their health and maintain active and fulfilling lives.
16142720|NCT01837875|Behavioral|Mail-delivered arthritis kit|"The Arthritis Self-Management Tool Kit contains 1) a Self Test to help participants determine how arthritis affects their lives and self-tailor the use of the Tool Kit, including items related to pain, fatigue, physical limitations, and health worries; 2) information sheets: Working with Your Doctor and the Health Care System; Exercise; Medications; Healthy Eating; Fatigue and Pain Management; Finding Community Resources; and Dealing with One's Emotions; 3) information sheets on key process components of the ASMP: Action Planning, Problem Solving, Deciding What to Try, and Individualizing an Exercise Program; 4) The Arthritis Helpbook; 5) audio relaxation and exercise compact discs (CDs); and 6) an audio CD of all material printed on the information sheets."
16142721|NCT01837875|Behavioral|Support group|"Interested participants will be referred to the Lupus: Listening and Learning Group, a Charleston-based support group affiliated with the Lupus Foundation of America (LFA). One to two LFA-trained facilitators implement the group. The meeting format generally includes a specific discussion topic or an informative presentation such as by a medical or counseling professional, pharmacist, or lupus researcher. This program is followed by time within the group for further interaction and support among the attendees who wish to participate. The Lupus: Listening and Learning Group is open to all lupus patients, family members, friends and supporters, and there is no pre-registration or fee involved."
16142722|NCT01837875|Behavioral|Listserv|A project listserv will be established to link all intervention participants to facilitate exchange of coping strategies, pose questions, and share preferred educational resources or any other information relative to their everyday and disease-specific experiences and/or participation in the project. Participants will be provided with a URL, from which they will be able to subscribe to the listserv. Once subscribed, they will be able to post and receive messages, managed by a listserv moderator, who will be responsible for distribution to listserv members as appropriate. Participants will have the option to unsubscribe at any time.
16142723|NCT01837862|Drug|Mebendazole|Mebendazole will be given orally twice daily for over the course of treatment (70 weeks for low-grade glioma patients, 48 weeks for high-grade glioma/pontine glioma patients). Mebendazole will be prescribed according to the particular dose cohort for each patient (50 mg/kg/day, 100 mg/kg/day, or 200 mg/kg/day).
16142724|NCT01837862|Drug|Vincristine|Low-grade glioma patients only. Vincristine will be dosed as per the following: For patients < 12kg: 0.05 mg/kg; for patient > 12kg: 1.5mg/m2 (maximal dose 2.0 mg). Vincristine will be administered intravenously on Day 1 of weeks 0,1,2,3,4,5 during the 10-week induction cycle and on Day 1 of Weeks 0,1,2 of the six 10-week maintenance cycles.
16142725|NCT01837862|Drug|Carboplatin|Low-grade glioma patients only. Carboplatin will be dosed at 175 mg/m2. Carboplatin will be administered intravenously on Day 1 of Weeks 0,1,2,3 of the 10-week Induction cycle, and on Day 1 of Weeks 0,1,2,3 during the six 10-week maintenance cycles.
16142726|NCT01837862|Drug|Temozolomide|Low-grade glioma patients only. Temozolomide will be dosed at 200 mg/m2/day. Temozolomide will be given orally for 5 days during Week 6 of the 10-week induction cycle and for 5 days during Week 6 of the six 10-week maintenance cycles.
16143035|NCT01835379|Device|Oasis|Oasis Ultra will be applied once per week for up to 12 weeks.
16143036|NCT01835379|Other|Standard|
16142727|NCT01837862|Drug|Bevacizumab|High-grade glioma/pontine glioma patients only. Bevacizumab will be dosed at 10mg/kg/dose. Bevacizumab will be administered intravenously on Days 1 and 15 of each maintenance cycle.
16142728|NCT01837862|Drug|Irinotecan|High-grade glioma/pontine glioma patients only. Irinotecan will be administered at doses 125 mg/m2, 150 mg/m2, 250 mg/m2, or 300 mg/m2, depending on patient tolerance and concomitant enzyme-inducing anti-epileptic medication use. Irinotecan will be administered intravenously on Days 1 and 15 of each maintenance cycle.
16142729|NCT01837836|Behavioral|Health education|Health education will include 1. Importance and demonstration of hygienic practices for safe drinking water 2. Promotion of water purification 3. Capacity building of community for safe water availability.
16142730|NCT01837823|Drug|rosuvastatin|All subjects will receive rosuvastatin 40mg/day for 8-12 weeks
16142731|NCT01837810|Drug|Ibuprofen|800mg every 8 hours as needed for pain
16142732|NCT01837797|Drug|Placebo|Once daily, tablets, orally
16142733|NCT01837797|Drug|Brexpiprazole 1 mg|once daily dose, tablets, orally
16142734|NCT01837797|Drug|Brexpiprazole 3 mg|once daily dose, tablets, orally
16142735|NCT01837784|Other|Optimization of blood pressure according to guidelines|There is no specific recommendation for the intervention. The goal of the intervention is an optimization of blood pressure control. The intervention is at the discretion of the physician, but should adhere to guidelines. The intervention may therefore embrace measures such as drug prescriptions or lifestyle interventions.
16142736|NCT01837771|Device|Diaphragmatic stimulation|
16142737|NCT01837745|Drug|rhTSH stimulation|Intramuscular injections of rhTSH (0.9 mg) on two consecutive days on LT4 treatment
16142738|NCT01837745|Drug|I131|An activity of 1.1 GBq of I131 is given orally 24 hours after the second injection of rhTSH.
16142739|NCT01837745|Other|Follow up|"10 (+/- 2 months) after randomization: a neck ultrasound and a serum Tg measurement after rhTSH or LT4 stimulation
~2 years (+/- 2 months) after randomization: a serum Tg measurement under LT4 treatment (Tg/LT4)
~3 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4
~4 years (+/- 2 months) after randomization: a serum Tg/LT4
~5 years (+/- 2 months) after randomization: a neck ultrasound and a serum Tg/LT4"
16142740|NCT01837732|Other|Relational Touch|"Relational touch 15 mn  relational touch, hand touch (neck, face and head)"
16142741|NCT01837732|Other|Relational:|Relational: 10 mn verbal patient's centered exchanges
16142742|NCT01837719|Drug|Atazanavir|300-mg capsule
16142743|NCT01837719|Drug|Cobicistat|150-mg tablet
16142744|NCT01837719|Drug|Atazanavir/Cobicistat FDC|Atazanavir 300-mg/cobicistat 150-mg FDC tablet
16142745|NCT01837693|Procedure|Experimental: immediate colposcopy|A immediate colposcopy in this arm may detect potentially spontaneous regressive cervical lesions, so may determine an over diagnosis and over treatment, which the study want to estimate
16142746|NCT01837680|Drug|Insulin|
16142747|NCT01837667|Drug|LB-100 for Injection|Part 1 and Part 2: LB-100 for Injection infusion on Days 1,2,3 of each 21 day cycle.
16142748|NCT01837667|Drug|Docetaxel|Part 2: Docetaxel infusion on Day 2 of each 21 day cycle.
16142749|NCT01837654|Behavioral|Plantarflexion 2nd wave|At the beginning of the 2nd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor.
16142750|NCT01837654|Behavioral|Plantarflexion - 3rd wave|At the beginning of the 3rd wave, patients will be asked to perform continuous plantar-flexion by pushing their tiptoes against the floor.
16142751|NCT01837641|Biological|LY3002813-IV|Administered IV
16142752|NCT01837641|Biological|LY3002183-SC|Administered SC
16142753|NCT01837641|Drug|Placebo-IV|Administered IV
16142754|NCT01837628|Drug|Lidocaine Gel|
16142755|NCT01837628|Drug|Paraffin Oil|
16142756|NCT01837615|Device|Photopill treatment|
16142757|NCT01837602|Biological|cMet RNA CAR T cells|
16142758|NCT01837589|Other|QCT|
16142759|NCT01837589|Other|DXA|
16142760|NCT01837576|Drug|Calcipotriol plus BDP gel in different doses|Topical , Once daily, 3 weeks
16142761|NCT01837550|Behavioral|Intervention group|The intervention group followed a five-week program that consisted of reading material, home training assignments, online and telephone interaction with an audiologist, and participation in a discussion forum.
16142762|NCT01837550|Behavioral|Control group|The control group only had access to reading material.
16142763|NCT01837524|Behavioral|KP Personal Shopper Visits|Testing co-shopping visits conducted in the grocery store (1:1 visits with dietitian while grocery shopping) versus in-office visits which are the current standard of care.
16142764|NCT01837524|Behavioral|In-Office Dietitian Visits|Participants will have 3, 1 hour in-office sessions with the dietitian during which targeted curriculum on nutritional knowledge, weight management, healthier eating, menu and label reading, will be delivered. These visits will take place monthly over a three month period.
16142765|NCT01837511|Other|Data acquisition and analysis|Tumor tissue samples submitted with a Patient and Tumor-Sample Characteristics. Form containing previously collected specific clinical data of patients with pathologically proven stage I, II and III NSCLC.
16142766|NCT01837498|Drug|Neostigmine|At the conclusion of the surgical procedure, neuromuscular block will be reversed with neostigmine
16142767|NCT01837498|Drug|Sugammadex|At the conclusion of the surgical procedure, neuromuscular block will be reversed with sugammadex
16142768|NCT01837485|Drug|Lactol|The Symbiotic Lactol® (Bioplus Life Sciences Pvt.) was applied 3 times a day for 3 months. Lactol is composed of the followings; Lactobacillus Sporogenes (15 × 107 Spores), Fructo-Oligosaccharides, Microcrystalline Cellulose, Sodium starch Glycolate, Povidone, Hypermellose Stearate, Sillicon Dioxide, and Propylene Glycol.
16142769|NCT01837485|Drug|Placebo|Placebo pill was applied 3 times a day for 3 months
16142770|NCT01837472|Drug|Probiotic|Patients in the probiotic group received the probiotic compound Balance® (Protexin Co., Somerset, UK) or similar placebo, twice daily after meal for 14 consecutive days. Balance® capsules contains seven bacteria species including Lactobacillus strains (L. casei, L. rhamnosus, L. acidophilus, and L. bulgaricus), Bifidobacterium strains (B. breve and B. longum), and Streptococcus thermophiles. Total viable count (TVC) is 1 x 108 CFU/per capsule. Other Ingredients are Fructo-oligosaccharide as prebiotic, magnesium stearate, and hydroxypropyl methyl cellulose.
16142771|NCT01837472|Drug|Placebo|Patients in the placebo group received the placebo capsule twice daily after meal for 14 consecutive days.
16142776|NCT01837433|Drug|Prednisone 1 week|Prednisone 1 week 30mg/day and Celecoxib 400mg in first day, and then 200mg bid in the remaining next week, total 2 weeks.
16142777|NCT01837433|Drug|Prednisone 6 weeks|Guidelines recommend
16142778|NCT01837420|Drug|VB-201 80mg|
16142779|NCT01837420|Drug|VB-201 160mg|
16142780|NCT01837420|Drug|Placebo|
16142781|NCT01837407|Procedure|Composite Flap|nerve transfer with the dorsal branch of the digital nerve
16142782|NCT01837394|Procedure|Block of the SN and ONP|7.5 ml of Ropivacaine 7.5 mg/ml injected at each site
16142783|NCT01837394|Procedure|Placebo block|7.5 ml of isotonic saline solution 154 mmol/l injected at each site
16142784|NCT01837394|Drug|Paracetamol|
16142785|NCT01837394|Drug|Morphine|5 mg as needed
16142786|NCT01837394|Drug|Ondansetron|4 mg i.v. as needed in the PACU
16142787|NCT01837394|Drug|Metoclopramide|10 mg tablet as needed in the postoperative period after discharge from the PACU
16142788|NCT01837381|Procedure|TEA|Arterial feeders to tumors were identified and catheterized with a microcatheter to a branch supplying a Couinaud segment or subsegmental level for delivery of the therapeutic agent, which was Lipiodol-ethanol mixture at 2:1 ratio by volume for TEA (Lipiodol Ultrafluide, Guerbet, France; Dehydrated alcohol [absolute alcohol], Martindale Pharmaceuticals, United Kingdom). The agents were delivered under fluoroscopic control to completely fill up the vasculature of all tumors. The maximum total volume of Lipiodol-ethanol mixture or cisplatin emulsion to be delivered in one treatment session was 60 mL.
16142789|NCT01837368|Other|observational research|It is a observational research, no intervention are performed
16142790|NCT01837355|Dietary Supplement|Lactobacillus rhamnosus|
16142791|NCT01837355|Dietary Supplement|Placebo|
16142792|NCT01837342|Procedure|Surgical reserction|
16142793|NCT01837342|Other|Radiological percutaneous drainage and washing drainage|
16142794|NCT01837329|Drug|Tetrathiomolybdate|"Dose Escalation - Dose level -1: 20 mg TM orally 3 x daily x 21 days in combination with carboplatin IV area under the curve (AUC) = 6 and pemetrexed IV 500/mgm2 day 1 x 1 cycle.
~Dose level 1: 40 mg TM orally 3 x daily x 21 days in combination with carboplatin IV AUC = 6 and pemetrexed IV 500 mg/m2 day 1 x 1 cycle.
~Dose level 2: 60 mg TM orally 3 x daily x 21 days in combination with carboplatin IV AUC = 6 and pemetrexed IV 500 mg/m2 day 1 x 1 cycle.
~Patients in the dose-expansion cohort will continue on carboplatin and pemetrexed (without TM) at the discretion of the treating physician.
~Dose Expansion - Maximum tolerated dose of TM determined from the dose-escalation cohorts combined with carboplatin IV AUC = 6 and pemetrexed IV 500 mg/m2 day 1 x 4 cycles."
16142795|NCT01837316|Drug|FF/VI 100/25 mcg|First strip: Fluticasone furoate inhalation powder blended with lactose, 100 mcg per blister
16142796|NCT01837316|Drug|Placebo|First strip: Inhalation powder of lactose
16142797|NCT01837303|Procedure|Pap smear|"A pap smear/cervical cytology is performed using a spatula and brush to obtain cells from the ectocervical and endocervical region of the cervix. The specimen will be collected twice to put in the standard clinical pap medium and another to put in the study pap medium.
~These slides will be processed so that they may be reviewed by a single board certified pathologist.
~There are no other interventions or follow up. All participants will undergo the above described procedures. There is no placebo."
16142798|NCT01837290|Drug|dexmedetomidine infusion for premedication|Group Dexmedetomidine (Group D): Midazolam 0.02 mg/kg + 0.5 μg/kg/10 min dexmedetomidine infusion for premedication; Spinal block (Hyperbaric bupivacaine 0.5% 12.5 mg) (n=30)
16142799|NCT01837290|Drug|Midazolam|intravenous Midazolam 0.02 mg/kg for premedication
16142800|NCT01837290|Drug|saline infusion|Saline infusion to facilitate blinding
16142801|NCT01837290|Drug|Spinal block with hyperbaric bupivacaine 0.5% 12.5 mg|Hyperbaric bupivacaine injection for spinal block
16142802|NCT01837277|Drug|Dolutegravir 50 mg|Use of Dolutegravir -based regimens: patients will receive a Dolutegravir -based ART regimen (RAL 400 mg BID + TDF 300 mg QD + 3TC 150 mg BID)
16142803|NCT01837277|Drug|Efavirenz-based regimens|Efavirenz-based regimens: patients will receive an EFV-based regimen (EFV 600 mg QD + TDGF 300 mg QD + 3TC 300 mg QD)
16142804|NCT01837264|Device|Magellan®|
16142805|NCT01837251|Drug|Carboplatin|
16142806|NCT01837251|Drug|PLD|
16142807|NCT01837251|Biological|Bevacizumab|
16142808|NCT01837238|Dietary Supplement|HMB|Following this initial round of testing,participant will be assigned to daily HMB supplementation for 6 months. You will be asked to consume a 1000mg HMB capsule 3 times per day, 7 days per week, for 6 months.
16142809|NCT01837238|Dietary Supplement|placebo|The placebo group will consume non-nutritive placebo pills daily for 6 months.
16142810|NCT01837199|Drug|Metronidazole plus Amoxicillin|All subjects will receive scaling and root planing combined with systemic metronidazole (400 mg) and amoxicillin (500 mg). Both antibiotics were administered T.I.D. for 14 days.
16142811|NCT01837160|Procedure|Cardiac MRI scan|Cardiac MRI scan with assessment of late gadolinium enhancement and T1 mapping.
16142812|NCT01837160|Radiation|CT-PET scan|Computed Tomography / Positron Emission Tomography scan with 18F-fluciclatide tracer.
16142813|NCT01837160|Procedure|Echocardiogram|Echocardiography.
16142814|NCT01837160|Radiation|CT-coronary angiogram scan|CT-coronary angiogram following CT-PET scan. Standard protocol.
16142815|NCT01837160|Procedure|Aortic Valve Replacement|For AVR (already scheduled prior to enrollment)
16142816|NCT01837147|Behavioral|Technology-Based Physical Activity Promotion|Participants assigned to this group will use a web-integrated physical activity monitor, and accompanying website, to improve their physical activity levels.
16142817|NCT01837147|Behavioral|Pedometer Intervention|Participants assigned to this group will receive a pedometer and be trained in its use.
16142818|NCT01837134|Device|telemedical (TM) group|telemedical devices (weighing machine and step counter)
16142819|NCT01837134|Behavioral|telemedical coaching (TMC) group|care calls once per week for 12 weeks
16142820|NCT01837121|Other|the SMS reminder message|the SMS reminder message will sent to the SMS group patients 1 week and 3 day before there appointment,to remind them the exact time and address of the revisit appointment.
16142821|NCT01837108|Drug|Eplerenone|2 tabs of eplerenone 25 mg will be over-encapsulated and a fully mimicking placebo will be provided by the department of clinical pharmacy of the Radboud University Medical Centre Nijmegen
16142822|NCT01837108|Drug|Placebo|
16142823|NCT01837095|Drug|POL6326|POL6326 will be given by i.v. infusion over 2 hours. Treatment will occur on days prior to, on the day of and on days after treatment with eribulin
16142824|NCT01837082|Drug|ferric carboxymaltose|
16142825|NCT01837082|Drug|Placebo|
16142826|NCT01837069|Drug|Metoprolol|25mg PO BID if the HR is elevated at preadmission testing
16142827|NCT01837069|Drug|Lisinopril|2.5mg PO QD if the HR is elevated at preadmission testing
16142828|NCT01837069|Drug|Atorvastatin|80mg PO QD at preadmission testing
16142829|NCT01837069|Behavioral|Lifestyle counseling|Diet, exercise, medication adherance and smoking counseling
16142830|NCT01837043|Drug|Belatacept|
16142831|NCT01837043|Drug|Calcineurin Inhibitor|
16142832|NCT01837030|Dietary Supplement|Ferrous sulfate|Ferrous sulfate 325mg by mouth twice daily for the duration of the 12 month follow up period
16142833|NCT01837030|Device|Capsule Endoscopy|GIVEN capsule
16142834|NCT01837017|Behavioral|Home-based Exercise|This is a control group with no intervention
16142835|NCT01837004|Behavioral|CORTEX|2-hour sessions for a period of four weeks prior to the initial exercise program start. One hour will be devoted to computerized training (stationary dual-task & cognitive control training, self-priming, certainty training) whereas the other hour will be devoted to exergaming involving non-stationary, dual-task training.
16142836|NCT01836991|Procedure|surgery|
16142837|NCT01836978|Other|Prehabilitation|Patients in this group will follow the multimodal protocol consisting of nutritional counseling with Immunocal® whey protein supplementation, an individualized physical exercise program and stress reduction strategies.
16142838|NCT01836965|Behavioral|Social Skills Intervention|Twelve week manual based social skills curriculum targeting social fluency and responsiveness.
16142839|NCT01836939|Drug|TSO 2500|TSO 2500: 2500 embryonated, viable TSO/15 mL/day every 2 weeks X 10 weeks
16142840|NCT01836939|Drug|TSO 7500|12 weeks of treatment with TSO 2500 ova or TSO 7500 ova given every 2 weeks (a total of 6 doses).
16142841|NCT01836926|Procedure|Open intersphincteric resection|"laparotomy arm: surgical Instruments for open approach operation: Abdominal anterior resection combined with peranal intersphincteric resection of the rectum
~Abdominal step a high ligation of the inferior mesenteric artery is performed together with a full mobilization of the left colon. A circular incision of the anal canal is performed 1 cm below the tumour. Both the mucosa and the muscular layer are incised to transect the internal anal sphincter. A coloanal anastomosis, transverse coloplasty or colonic J-pouch and a diverting loop ileostomy are associated with the hand-sewn coloanal anastomosis.
~laparoscopic approach group: instruments used: laparoscopic instruments mentioned at the arm description
~intervention: laparoscopic mobilization of the rectum and colon combined with the peranal intersphincteric resection as in the laparotomy approach"
16142842|NCT01836926|Device|transanal minimally invasive intersphincteric resection|minimally invasive approach group: instruments used: laparoscopic instruments mentioned at the arm description instruments: laparoscopic instruments mentioned in the laparoscopic rectal resection arm intervention: laparoscopic mobilization of the rectum and colon combined with the peranal intersphincteric resection as in the laparotomy approach
16142843|NCT01836900|Device|Endoscopic hemostasis|Hemostasis with Standard Therapy (standard clip or thermal therapy + injection of adrenaline solution) or by application of the Over The Scope Clip and injection of adrenaline solution
16142844|NCT01836887|Dietary Supplement|Very low polyphenol fruit based drink (control)|
16142845|NCT01836887|Dietary Supplement|Polyphenol-enriched fruit-based drink - low|
16142846|NCT01836887|Dietary Supplement|Polyphenol-enriched fruit-based drink - high|
16142847|NCT01836874|Drug|No intervention|This is an observational study. Participants receiving topiramate 25 mg once-a-day for 1 week and later on, receiving increase dose up to 200 mg, twice-a-day, orally will be observed for 3 months.
16142848|NCT01836861|Drug|IPI-145|Intravenous infusion: approximately 2.8 μg IPI-145 containing 14.8 kBq of radioactivity; Oral suspension: 25 mg IPI-145 containing approximately 3.15 MBq of radioactivity; Oral capsule: 25 mg IPI-145
16142849|NCT01836848|Procedure|measuring cerebral perfusion by NIRS with ICG|application of a bolus of 5mg indocyanine green (ICG) in 3ml saline 0,9% i.v. in 1 second and measuring the ICG turnover with the near-infrared-spectroscopy (NIRS)
16142850|NCT01836835|Other|Pregnancy Unique Questionnaire of Emesis (PUQE)|For hyperemesis gravidarum patients the Pregnancy Unique Questionnaire of Emesis (PUQE) (3 questions regarding the amount of nausea and vomiting during 24 hours) will be answered both at hospital admittance and discharge. For control patients the questionnaire will be answered at inclusion.
16142851|NCT01836835|Other|24 hours self-reported nutritional intake form|A nutritional intake form where relevant food and liquid items can be checked prospectively after consummation during 24 hours. This form will be filled in starting the morning following inclusion.
16142852|NCT01836822|Procedure|EBUS guided transbronchial forceps biopsy (EBUS-TBFB)|
16142853|NCT01836822|Procedure|EBUS guided transbronchial needle aspiration (EBUS-TBNA)|
16142854|NCT01836822|Procedure|large bore (19G) histologic needle biopsy of the mediastinal lymph nodes|
16142855|NCT01836822|Procedure|Bronchoalveolar lavage (BAL)|
16142856|NCT01836822|Procedure|Endobronchial forceps biopsy|
16142857|NCT01836809|Drug|nesiritide|nesiritide at 0.005 mcg/kg/min without a bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours.
16142858|NCT01836809|Drug|placebo|placebo bolus starting 6 hours after the subject has come off of cardiopulmonary bypass and will continue for 48 hours.
16142859|NCT01836796|Dietary Supplement|Lactobacillus Reuteri|100 million Lactobacillus Reuteri once daily or 10 billion Lactobacillus Reuteri once daily for 12 weeks.
16142860|NCT01836796|Dietary Supplement|Lactobacillus Reuteri DSM17938|Powder corresponding to 100 million or 10 billion Lactobacillus Reuteri is added to water once daily for 12 weeks.
16142861|NCT01836783|Other|Amnion Allograft|Atraumatic extraction and grafting procedures will be followed by insertion of a dental implant into the grafted area at week-8. The implant will be restored and be monitored for 24 months post-insertion. Two special dental cone-beam CT images (pre-baseline and week-7) and a minimum of 6 intraoral radiographs will be taken during the study
16142981|NCT01835886|Other|Patients will ascend and descend a flight of 10 steps|Patients referred to pulmonary rehabilitation with documented lung disease will ascend and descend a flight of 10 steps for a period of 30 seconds
16142862|NCT01836783|Other|Allograft|Atraumatic extraction and grafting procedures will be followed by insertion of a dental implant into to the grafted area at week-8. The implant will be restored and be monitored for 24 months post-insertion. Two special dental cone-beam CT images (pre-baseline and week-7) and a minimum of 6 intraoral radiographs will be taken during the study
16142863|NCT01836757|Drug|MethylSulfonylMethane (MSM)|Intervention is MSM 3 gr twice a day for 26 weeks (6 gr/day total)
16142864|NCT01836757|Drug|Placebo|
16142865|NCT01836744|Device|Survival rate dental implant (OsseoSpeed™)|
16142866|NCT01836731|Behavioral|Classic Intervention|"The standard classic approach will implement a total of 20 community health club sessions delivered through weekly education programs in the target communities as per the training manual. Community health workers (CHW) will receive careful training in the delivery of the CBEHPP instruction. High quality instructional materials (in color) will be used. Club members will each receive a membership card to be used to track attendance and compliance. Finally model home competitions and a graduation ceremony will be held. Monitoring of the clubs will be conducted by community health workers using mobile phones."
16142867|NCT01836731|Behavioral|Minimum Intervention|"The lite trial arm will only implement 8 sessions covering all the WASH topics. It will be facilitated by CHWs receiving minimal training and using black/white photocopies of instructional materials. Members will not be issued with membership cards and will not have a graduation ceremony or home garden competitions. Minimal monitoring of this arm will be carried out by environmental health officers."
16142868|NCT01836705|Drug|SAR302503 (TG101348)|"Pharmaceutical form:capsule
~Route of administration: oral"
16142869|NCT01836705|Drug|Placebo SAR302503|"Pharmaceutical form:capsule
~Route of administration: oral"
16142870|NCT01836705|Drug|Panolosetron|"Pharmaceutical form:solution
~Route of administration: intravenous"
16142871|NCT01836692|Radiation|Intensity Modulated Radiotherapy treatment|Intensity Modulated Radiotherapy treatment
16142872|NCT01836679|Drug|Chidamide|Given orally
16142873|NCT01836679|Drug|Paclitaxel|Given IV
16142874|NCT01836679|Drug|Carboplatin|Given IV
16142875|NCT01836679|Drug|Placebo|Given orally
16142876|NCT01836653|Drug|Bevacizumab|5 mg/kg intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.
16142877|NCT01836653|Drug|Cetuximab|250 mg/m2 intravenously administered over 60 minutes (400 mg/m2 over 120 minutes as the initial dose) on day 1 and day 8 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.
16142878|NCT01836653|Drug|L-OHP|85 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.
16142879|NCT01836653|Drug|l-LV|200 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.
16142880|NCT01836653|Drug|5-FU|400 mg/m2 intravenous bolus on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.
16142881|NCT01836653|Drug|5-FU|2400 mg/m2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.
16142882|NCT01836627|Other|Hyperinsufflation therapy|15 minutes twice a day of hyperinsufflation with Cough Assist® device
16142883|NCT01836614|Drug|Lidocaine|The treatment group will receive a 1.5mg/kg intravenous lidocaine bolus over 10 minutes after induction by means of an infusion pump. This bolus will be followed by an intravenous lidocaine infusion of 1 mg/kg/hr. The infusion will be stopped after extubation prior to leaving the operative room or after 5 hours from the start of the infusion, which ever comes first.
16142884|NCT01836601|Behavioral|Family-centered nighttime communication bundle|
16142885|NCT01836588|Procedure|conventional cervix biopsy|"Object of this study is the evaluation of two different methods of gaining cervical tissue in order to determine whether, and if so in what extent, a CIN is existent. The first method is a cervical biopsy, the second method is a gentle tissue saving curettage of the cervix uteri. Also is to be investigated that the latter method shows a reduction of pain and morbidity after the procedure.
~For this reason the pathological outcome of the two methods will be compared to the result of a conisation, which will be received by the patient to cure their cervical lesions."
16142886|NCT01836575|Drug|Pemetrexed|Pemetrexed, 500 mg/m2 + Pretreatment [dexamethasone + vitamin B12 + folic acid, as per pemetrexed label] + Antiemetic therapy at investigator's discretion.
16142887|NCT01836575|Drug|Carboplatin|Carboplatin [Target AUC 5 IV infusion,based on Calvert formula,GFR estimated using estimated creatinine clearance per Cockcroft and Gault formula, obtained prior to each cycle].
16142888|NCT01836562|Biological|STEM CELL THERAPY|Intra thecal injection of autologous MNC ,Intra thecal inj.of 100 millions MNC in 3 doses at 10 days interval.
16142889|NCT01836549|Drug|imetelstat sodium|Given IV
16142890|NCT01836536|Drug|Bevacizumab standard of care|Standard treatment associated with circulating leucocytes (blood samplings)
16142891|NCT01836523|Drug|liraglutide|Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.
16142892|NCT01836523|Drug|placebo|Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.
16142893|NCT01836523|Drug|liraglutide|Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.
16142894|NCT01836523|Drug|placebo|Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.
16142895|NCT01836523|Drug|liraglutide|Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.
16142982|NCT01835873|Other|Lactated Ringer's|
16142896|NCT01836523|Drug|placebo|Subjects randomised to 0.6 mg liraglutide treatment or liraglutide placebo as an add-on to their pre-trial insulin treatment will remain on this dose throughout the study (52 weeks). Administered subcutaneously (s.c., under the skin) once daily.
16142897|NCT01836497|Device|SD01 ICD lead|
16142898|NCT01836484|Diagnostic Test|Diffusion-weighted MRI|
16142899|NCT01836484|Diagnostic Test|Fluorodeoxyglucose-18-PET/CT|
16142900|NCT01836484|Diagnostic Test|Fluoro-ethyl-coline-PET/CT|
16142901|NCT01836471|Drug|QAW039|QAW039 supplied as hard gelatin capsule in unit dose strength of 150 mg. Patient took 450 mg once daily (3 capsules taken with food in the morning) for the approximate period of the study (12 weeks)
16142902|NCT01836471|Drug|Placebo QAW039|Matching placebo for QAW039 supplied as hard gelatin capsule were identical in appearance to their active counterparts. Patients took 3 QAW039 matching placebo capsules once a day ( taken with food in the morning) for the approximate period of the study (12 weeks)
16142903|NCT01836471|Drug|Fluticasone 250 mcg|Fluticasone was supplied in inhalers with dose strength of 250 mcg. Patients took 250 mcg bid (morning and evening approximately 12 hours between doses) for a total dose of 500 mcg daily for the approximate period of the study (12 weeks).
16142904|NCT01836471|Drug|Fluticasone 100 mcg|Background therapy - fluticasone was supplied in inhalers with dose strength of 100 mcg. All patients in the study other than the Atopic Fluticasone 150 mcg arm were given the 100 mcg dose strength inhalers and took fluticasone 100 mcg bid (taken morning and evening with approximately 12 hours between doses) as background therapy for the approximate period of the study (12 weeks).
16142905|NCT01836458|Drug|KAE609|Patients will receive KAE609 single dose at a different dose level in each cohort.
16142906|NCT01836445|Behavioral|Keep It Up!|
16142907|NCT01836445|Behavioral|HIV Knowledge Control|
16142908|NCT01836432|Drug|FOLFIRINOX|FOLFIRINOX consisting of Oxaliplatin 85 mg/m^2 IV over 2 hours; Irinotecan 180 mg/m^2 IV over 90 minutes; Leucovorin 400 mg/m^2 IV over 2 hours; Fluorouracil 2.4 g/m^2 IV over 46 hours
16142909|NCT01836432|Biological|Algenpantucel-L Immunotherapy|Algenpantucel-L Immunotherapy (HAPa) consisting of 300 Million HAPa cells given by intradermal injection
16142910|NCT01836432|Radiation|5-FU Chemoradiation|5-FU Chemoradiation consisting of 5-FU continuous IV infusion of 200-250 mg/m^2/day given 5-7 days each week over 5.5 weeks concurrently with external beam radiation
16142911|NCT01836432|Drug|Gemcitabine|Gemcitabine 1000 mg/m^2 given intravenously over 30 minutes for 3 weeks (days 1, 8 and 15) with 1 week rest.
16142912|NCT01836432|Drug|Capecitabine|Capecitabine consisting of 825 mg/m^2 PO BID M-F concurrently with external beam radiation
16142913|NCT01836432|Drug|Nab-Paclitaxel|Nab-Paclitaxel 125 mg/m^2 given intravenously over 30-40 minutes
16142914|NCT01836419|Procedure|classic LMA insertion|
16142915|NCT01836406|Drug|Ketorolac tromethamine and remote ischemic preconditioning|Ketorolac tromethamine/ single / 1mg/kg/ intravenous administration 30 min before renal artery clamping, remote ischemic preconditioning / 200 mmHg / 5 min inflation and 10 min deflation / 3 cycles / after anesthetic induction
16142916|NCT01836393|Drug|Plavina cream|The essential plai cream has anti-inflammatory and antimicrobial effects (Wasuwat1989, Giwanon 2000, Pithayanukul 2007, and Tripathi 2008). Active chemicals of plai cream are composed of sabinene, alpha and gamma tepinenes, terpinen 4-ol and (E)-1-(3,4-dimethoxyphenyl butadiene (DMPBD). The DMPBD has a property of anti-inflammatory activity(Ozaki 1991, Jeenapongsa 2003). Plavina® 40 mg in 100 gm (contains DMPBD of …%). This product was supplied in lacquered aluminum collapsible tube containing 100 gram cream packing.
16142917|NCT01836380|Behavioral|Exercise Training|
16142918|NCT01836367|Drug|Ingenol Mebutate 0.015%|Picato
16142919|NCT01836354|Behavioral|DESERVE education|Those patients assigned to education will receive stroke comprehensive intervention which focuses on three main areas, Risk perception, Medication Adherence, and Patient-Physician Communication. We will test whether phone calls and visits with a health worker after discharge, videos and a workbook are linked to better control of blood pressure and other risk factors
16142920|NCT01836341|Drug|Afatinib|
16142921|NCT01836341|Drug|Cisplatin|
16142922|NCT01836341|Drug|Carboplatin|
16142923|NCT01836341|Drug|Pemetrexed|
16142924|NCT01836341|Radiation|Radiation therapy|
16142925|NCT01836328|Drug|Parenteral /oral methadone ratio 1:2|"See arm/group descriptions"
16142926|NCT01836328|Drug|Parenteral /oral methadone ratio 1:1.2|"See arm/group descriptions"
16142927|NCT01836315|Other|Observational Study|
16142928|NCT01836302|Other|Observation|
16142929|NCT01836289|Drug|High-dose Cyclophosphamide|
16142930|NCT01836276|Drug|Varenicline|1 mg of varenicline twice daily after titration to full strength in the first week following standard dosing guidelines
16142931|NCT01836237|Device|Alexis - a wound protector|Alexis is a double ring, self-retaining circumferential device that is designed to protect incision site during surgical manipulation.
16142932|NCT01836224|Drug|Terlipressin|Terlipressin (1.3mcg/min i.e 2mg over 24 hr to max of terlipressin 5.2mcg/min i.e. up to 8mg over 24hr) .The dose to be increased every 15min from start dose by 1ml and to decrease by 0.5ml every 15min keeping MAP (Mean Arterial Pressure) >65 .Terlipressin 2mg in 48ml,1ml=42mcg=0.67mg/min, max dose 8mg/day- 8ml/hr of infusion.
16142933|NCT01836224|Drug|Noradrenaline|Noradrenaline 2amp (4000mcg in 50ml) at 6ml/hr = 7.5mcg/min and dose maximum 60mcg/min 24ml/hr double strength. The dose to be increased every 15min from start dose by 1ml and to decrease by 0.5ml every 15min keeping MAP (Mean Arterial Pressure)>65
16142934|NCT01836211|Other|Fast strategy|High sensitivity troponin T followed by computed coronary tomography angiography
16142935|NCT01836211|Other|Standard of care strategy|Standard of care strategy: serial electrocardiograms and cardiac biomarkers followed by stress/rest cardiac imaging study
16142936|NCT01836198|Drug|LY2409021|
16142937|NCT01836198|Drug|Gemfibrozil|
16142938|NCT01836198|Drug|Ketoconazole|
16142939|NCT01836198|Drug|Clarithromycin|
16142940|NCT01836185|Drug|Evacetrapib|
16142941|NCT01836172|Drug|YJP-14|An 50% ethanolic extract of Lindera obtusiloba stems
16142983|NCT01835873|Other|HES 130/0.42|Balanced colloid solution
16142984|NCT01835860|Procedure|Prostate artery embolization|
16142985|NCT01835847|Drug|Tipepidine Hibenzate|
16142986|NCT01835834|Procedure|zirconia bridge restoration|
16142942|NCT01836159|Other|iPad Intervention|"Patients are to self-administer 20 minutes of gaming sessions, in any configuration that is preferred. Patients will be instructed to play the iPad game with the more affected arm/hand. Start and stop times of the iPad intervention will be downloaded from the iPad, which will allow calculation of the total dose received. Patients may receive outpatient rehabilitation as required as part of usual care.
~The 'Stroke Rehab' software for the iPad was specifically designed for patients with either fine motor weakness and/or neglect. It contains 6 stages:
~Popping a stationary balloon
~Popping a moving balloon
~Popping a pair of stationary balloons
~Popping a pair of moving balloons
~Stretching a balloon to pop
~Balloon/Text distraction test"
16142943|NCT01836159|Other|Standard/ Usual Care|Patients may receive outpatient rehabilitation as required as part of usual care. Patients will be instructed not to play with an iPad during the 2 week intervention period (in case they have one).
16142944|NCT01836146|Device|EnligHTN™ Renal Artery Ablation Catheter|
16142945|NCT01836133|Drug|Erlotinib 150 mg|
16142946|NCT01836120|Drug|Raltitrexed plus Docetaxel|"Raltitrexed plus Docetaxel (Raltitrexed 3mg/m2 d
~1; Docetaxel 75mg/m2 d1, every 3 weeks, 4-6 cycles)"
16142947|NCT01836120|Drug|Docetaxel|Docetaxel (Docetaxel 75mg/m2 d1, every 3weeks,4-6 cycles)
16142948|NCT01836094|Drug|Methylene Blue (USP grade, 280mg oral)|
16142949|NCT01836094|Drug|Placebo|oral, one time
16142950|NCT01836081|Other|Volume expansion|
16142951|NCT01836068|Drug|Enfuvirtide|Enfuvirtide 90 mg subcutaneously twice daily will be administered to all patients on day 3 and 4 post-transplant and during any periods when oral medications are not expected to be tolerated for ≥ 24 hours, or during periods when ART is held due to interactions
16142952|NCT01836029|Drug|VTX-2337|TLR8 Agonist
16142953|NCT01836029|Drug|Carboplatin|
16142954|NCT01836029|Drug|Cisplatin|
16142955|NCT01836029|Drug|5-fluorouracil|
16142956|NCT01836029|Drug|Placebo|
16142957|NCT01836016|Drug|Salbutamol (Ventolin®)|According to the revised 2011 GOLD, patients will be divided into Group A, B, C, and D based on individualized assessment. Salbutamol was used to Group A patients for 26 weeks: Salbutamol (Ventolin®, GlaxoSmithKline) 100μg/dose, 200 inhalations. 100 μg each time (when needed), and the maximum dose is 8-12 inhalations a day.
16142958|NCT01836016|Drug|Formoterol (Oxis Turbuhaler®)|According to the revised 2011 GOLD, patients will be divided into Group A, B, C, and D based on individualized assessment. Formoterol was used to Group B patients for 26 weeks: Formoterol (Oxis Turbuhaler®, AstraZeneca), 4.5μg/ dose, 60 inhalations. 4.5μg each time, twice daily.
16142959|NCT01836016|Drug|Salmeterol / fluticasone (Seretide®)|According to the revised 2011 GOLD, patients will be divided into Group A, B, C, and D based on individualized assessment. Salmeterol / fluticasone was used to Group C patients and Group D patients for 26 weeks: Salmeterol / fluticasone (Seretide®, GlaxoSmithKline), 50/500 μg / dose, 60 inhalations. 50/500 μg each time, twice daily.
16142960|NCT01836016|Drug|Bufei granule|According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of lung-qi deficiency will be given Bufei granule, twice daily for 26 weeks for lower dosage.
16142961|NCT01836016|Drug|Bufeijianpi granule|According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of deficiency of pulmonic-splenic qi will be given Bufeijianpi granule, twice daily for 26 weeks for lower dosage.
16142962|NCT01836016|Drug|Bufeiyishen granule|According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi of the lung and kidney will be given Bufeiyishen granule, twice daily for 26 weeks for lower dosage.
16142963|NCT01836016|Drug|Yiqizishen granule|According to traditional Chinese syndrome differentiation and treatment, patients with syndrome of insufficiency of qi and yin of the lung and kidney will be given Yiqizishen granule, twice daily for 26 weeks for lower dosage.
16142964|NCT01836016|Drug|conventional medicine + TCM|Patients will be given the combination of conventional medicine (Salbutamol, Formoterol, Salmeterol / fluticasone, Salmeterol / fluticasone) and (Bufei granule, Bufeijianpi granule, Bufeiyishen granule and Yiqizishen granule) for 26 weeks.
16142965|NCT01836003|Other|Tokafatso programmatic intervention|"Tokafatso programmatic intervention:
~SMS-based platform for delivery of CD4 test results
~Participatory educational session for clinic staff
~Loan program for HIV and CD4 testing supplies
~Facilitation of tracing of HAART-eligible pregnant women"
16142966|NCT01835990|Device|geko|The geko is a neuromuscular stimulation device that stimulates the common peroneal nerve resulting in contraction of the leg muscles and increased venous and arterial flow. It is Health Canada approved for prevention of deep venous thrombosis.
16142967|NCT01835990|Device|IPCs|devices that pneumatically compress the leg, resulting in increased venous blood flow.
16142968|NCT01835977|Device|Irreversible Electroporation (Nanoknife)|
16142969|NCT01835964|Procedure|Glucose Variability Observation|On the morning of ~Day 17 for a metabolic challenge involving a standardized liquid mixed meal intended to raise the blood glucose approximately 150 mg/dl, followed four hours later by the induction of hypoglycemia with intravenous insulin administration with goal glucose of 55 mg/dl. After carbohydrate rescue, the subject will receive a meal and will be monitored until glucose is stable above 80 mg/dl.
16142970|NCT01835951|Other|Grouped Debriefing|Debriefing consists in an analysis by the investigator of the management of the anaesthesia crisis simulated in the presence of all the subjects included in the Groupe Debriefing group.
16142971|NCT01835951|Other|Individual Debriefing|Individual debriefing consists in a individual meeting between each subject of the study and the investigator to analyze the management of the anaesthesia crisis simulated.
16142972|NCT01835938|Drug|1- Erlotinib|"Erlotinib 50 mg tablet by mouth every day for 14 days,
~Erlotinib 100 mg tablet by mouth every day for 14 days,
~Erlotinib 150 mg tablet by mouth every day for 14 days,"
16142973|NCT01835938|Drug|placebo|"Placebo 50 mg tablet by mouth every day for 14 days,
~Placebo 100 mg tablet by mouth every day for 14 days,
~Placebo 150 mg tablet by mouth every day for 14 days,"
16142974|NCT01835925|Genetic|Tissue specimen|
16142975|NCT01835912|Other|Sodium Citrate Dihydrate|Dose sodium citrate dihydrate through 2 dosing protocols (Acute and Chronic)
16142976|NCT01835899|Drug|Placebo|Placebo to BI 1015550
16142977|NCT01835899|Drug|BI 1015550|medium dose 1 powder for oral solution
16142978|NCT01835899|Drug|BI 1015550|medium dose 2 powder for oral solution
16142979|NCT01835899|Drug|BI1015550|low dose 2 powder for oral solution
16142988|NCT01835808|Device|Fractional flow reserve (St. Jude Medical pressure-wire)|CAD patients submitted to coronary angiography and in which coronary lesions are to be evaluated with pressure-wire (FFR functional evaluation)
16142989|NCT01835795|Device|Swiss DolorClast® CLASSIC applicator|Radial Extracorporeal Shock Wave applicator use in 6 sessions with 1 week of interval, 1000 impulses per myofascial trigger point, 5 to 7 hertz frequency, 2 to 4 bar pressure
16142990|NCT01835795|Device|Swiss DolorClast® CLASSIC placebo applicator|Placebo applicator, use in 6 sessions with 1 week of interval, 1000 impulses per myofascial trigger point, 5 to 7 hertz frequency, 2 to 4 bar pressure
16142991|NCT01835782|Drug|L-Serine|
16142992|NCT01835756|Device|Erchonia MLS|The Erchonia® MLS contains 10 independent diodes, each emitting 17 milliwatts (mW), 635 nanometers (nm) of red laser light. The Erchonia MLS is applied to the lower back and hips area for 15 minutes per treatment administration, 6 times across 3 weeks, 2 times per week.
16142993|NCT01835756|Device|Placebo Laser|The Placebo Laser has the same appearance and administration application as the Erchonia MLS but does not emit any therapeutic light.
16142994|NCT01835743|Device|Erchonia HPS Laser|The Erchonia HPS Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration.
16142995|NCT01835743|Device|Placebo Laser|The Placebo Laser is administered to the subject's heel 6 times across 3 consecutive weeks, 2 times each week, for 10 minutes of treatment time per administration.
16142996|NCT01835730|Drug|PE0139 Injection|
16142997|NCT01835730|Drug|Placebo|
16142998|NCT01835704|Other|Radio-frequency dennervation of facet joint|
16142999|NCT01835704|Other|Diagnostic nerve-blocks performed under direct x-ray vision|
16143000|NCT01835691|Dietary Supplement|Vitamin D2 (ergocalciferol)|50,000 units once a week for 12 weeks
16143001|NCT01835691|Dietary Supplement|Vitamin D3 (cholecalciferol)|50,000 units once a week for 12 weeks
16143002|NCT01835678|Drug|Linagliptin|orally 5 mg/d for 4 weeks
16143003|NCT01835678|Drug|Placebo|orally once a day for 4 weeks
16143004|NCT01835665|Drug|Nimodipine|Nimodipine is an FDA-approved drug for subarachnoid hemorrhage indication
16143005|NCT01835652|Other|Active Exercise|
16143006|NCT01835652|Other|Passive Exercise|
16143007|NCT01835639|Dietary Supplement|Cholecalciferol, 2000 or 4000 IUs by mouth daily for 12 weeks|Supplements will be provided as oral capsules.
16143008|NCT01835626|Drug|Vismodegib|Vismodegib will be taken daily for 12 weeks. It should be taken at approximately the same time each day. Patients will be given a supply of vismodegib on Week 1, Day 1 to last until their next study visit. They will be asked to keep a record of each dose of vismodegib you take. After 12 weeks, they will be evaluated again to make sure they are still eligible to participate in the study. If they are eligible to continue, they will continue taking vismodeib daily as before for another 7 weeks while they receive radiation therapy.
16143009|NCT01835626|Radiation|Radiation therapy|Radiation therapy will be started after the patient has finished taking vismodegib for 12 weeks. They will receive radiation once a day, Monday through Friday, for 7 weeks. Each radiation treatment may take up to 30 minutes.
16143010|NCT01835613|Other|Biomarkers Measures|At the routine visits (0, 3, 6, 12 and 18 months), a clinical evaluation will be made and samples collected for assaying the biomarkers.
16143011|NCT01835600|Other|PEEP|PEEP means that when mechanical ventilation is suspended, the value of expiratory valve in the anesthesia machine is set at 10 cmH2O with 1 L/min 100% oxygen.
16143012|NCT01835587|Drug|CC-486|Cohorts of 3 to 6 subjects will be treated at escalating or de-escalating sequential dose levels until a preliminary Maximum Tolerated Dose (MTD) is identified.
16143013|NCT01835574|Behavioral|Conditional cash transfer and cognitive-behavioral aftercare|The intervention combines a 12-week conditional cash transfer (CCT) intervention with 4-weeks of cognitive-behavioral group aftercare (AC) among women who use ATS. CCT includes thrice weekly urine screening for 12 weeks; participants receive $ for ATS-negative screens. Those with 3 negative screens in a week participants receive a cash bonus, which increase per month to mitigate habituation to the CCT reward schedule. Women who complete >=50% of ATS negative screening visits may participate in a 4-week, cognitive-behavioral AC group delivered immediately after CCT, which includes: 1) experiential group exercises; 2) didactic recovery skills training; 3) meditation and relaxation training; and 4) a ''lucky draw'' which is a form of CCT that provides positive reinforcement for group attendance.
16143014|NCT01835561|Drug|Pomalidomide|Single oral dose of 4-mg capsule
16143015|NCT01835561|Drug|Pomalidomide|4-mg capsule
16143016|NCT01835548|Drug|NT0102|NT0102 (methylphenidate polistirex [MPP] extended release [XR] ODT) was given once daily at a dose equivalent to 20-60 mg methylphenidate hydrochloride.
16143017|NCT01835548|Drug|Placebo|Matching ODT placebo was given once daily.
16143018|NCT01835535|Device|TIVUS|
16143019|NCT01835509|Behavioral|Intervention, Camp plus reunions|
16143020|NCT01835496|Drug|single 1500 mg dose of Ferriprox|A single dose of 1500mg of Ferriprox (three 500mg tablets) administered under fasting conditions
16143021|NCT01835470|Drug|Abatacept|
16143022|NCT01835457|Drug|Lipopolysaccharide|LPS is used to elicit an inflammatory response in all subjects.
16143023|NCT01835457|Behavioral|Concentration/meditation|A self-taught concentration/meditation technique that Mr Wim Hof developed himself, characterized by cycles consisting of a few minutes of hyperventilation followed by breath holding for up to 1-2 minutes and deep concentration (mindset).
16143024|NCT01835444|Other|PA/MD model|Intervention wards are hospital wards at which ward care is provided by both Physician Assistants (PAs) and Medical Doctors (MDs)
16143025|NCT01835431|Drug|insulin degludec/insulin aspart|Administered subcutaneously (s.c., under the skin) once daily with a main meal. Dose individually adjusted.
16143026|NCT01835431|Drug|insulin aspart|Administered s.c. with the remaining meals. Dose individually adjusted.
16143027|NCT01835431|Drug|insulin detemir|Administered s.c. once or twice daily. Dose individually adjusted. Subjects will continue with their pre-trial dosing scheme (once (OD) or twice daily (BID)) and will be allowed to switch from OD to BID dosing.
16143028|NCT01835431|Drug|insulin aspart|Administered s.c. at meal-times. Dose individually adjusted.
16143029|NCT01835418|Drug|Amlodipine|crossover comparison of amlodipine vs lisinopril
16143030|NCT01835405|Device|LiquiBand Flex|
16143031|NCT01835405|Device|Dermabond Advanced|
16143038|NCT01835353|Drug|Prasugrel 60mg loading dose|Prasugrel 60mg loading dose
16143039|NCT01835340|Device|Drug: Propofol Anesthesia Patients will undergo propofol anesthesia.|
16143040|NCT01835314|Drug|Stiripentol|Stiripentol 5-50mg/kg/d divided twice or three times a day by mouth
16143041|NCT01835288|Drug|arsenic trioxide|Given IV
16143042|NCT01835288|Other|laboratory biomarker analysis|Correlative studies
16143043|NCT01835275|Behavioral|Enhanced Audio|
16143044|NCT01835275|Behavioral|Audio|
16143045|NCT01835262|Drug|Morphine|Morphine: 0.1 mg /kg given as IVP
16143046|NCT01835262|Drug|Ketamine|Ketamine:0.3 mg/given as IVP
16143047|NCT01835249|Other|Intensive BP Arm|Participants in the Intensive arm have a goal of SBP <120 mmHg.
16143048|NCT01835249|Other|Standard BP arm|Participants in the Standard BP arm have a goal of SBP <140 mmHg.
16143049|NCT01835236|Drug|Trastuzumab|"First administration (loading dose) 8 mg/kg i.v. infusion over 90 min.
~- then every 3 weeks until progression 6 mg/kg i.v. infusion over 30 to 90 min."
16143050|NCT01835236|Drug|Pertuzumab|"First administration (loading dose) 840 mg i.v. infusion over 60 min.
~- then every 3 weeks until progression 420 mg i.v. infusion over 30 to 60 min."
16143051|NCT01835236|Drug|Paclitaxel|Day 1, 8 and 15; every 4 weeks for ≥4 months 90 mg/m2 i.v. infusion
16143052|NCT01835236|Drug|Vinorelbine|"First administration: Day 1 and 8 25 mg/m2 i.v. infusion
~then day 1 and 8, every 3 weeks for ≥4 months 30 mg/m2 i.v. infusion"
16143053|NCT01835236|Drug|T-DM1|Every 3 weeks until unacceptable toxicity or progressive disease is observed 3.6 mg/kg i.v. infusion First dose: over 90 min (± 10 min.) Subsequent doses: over 30 min. (± 10 min.)
16143054|NCT01835223|Drug|Tivozanib (1mg)|Given PO
16143055|NCT01835223|Drug|Tivozanib (1.5mg)|Given PO
16143056|NCT01835197|Drug|PF-04965842|Subjects will receive single doses of 3, 10, 30, 100, 200, 400, or 800 mg of PF-04695842 (solution or suspension) in a dose escalation format.
16143057|NCT01835197|Drug|Placebo|Subjects will receive single doses of PF-04695842 matching placebo (solution or suspension) in a dose escalation format.
16143058|NCT01835197|Drug|PF-04965842|Subjects will receive doses of 30, 100 or 200 mg (solution or suspension) once daily for 10 days.
16143059|NCT01835197|Drug|Placebo|Subjects will receive PF-04965842 matching placebo (solution or suspension) once daily for 10 days.
16143060|NCT01835197|Drug|PF-04965842|Subjects will receive doses of 100 or 200 mg (suspension or solution) twice daily for 10 days.
16143061|NCT01835197|Drug|Placebo|Subjects will receive PF-04965842 matching placebo doses (suspension or solution) twice daily for 10 days.
16143062|NCT01835197|Drug|PF-04965842|Subjects will receive 200 mg dose (suspension or solution) twice daily for 10 days.
16143063|NCT01835197|Drug|Placebo|Subjects will receive PF-04965842 matching placebo dose (suspension or solution) twice daily for 10 days.
16143064|NCT01835197|Drug|PF-04965842|Subjects will receive 400 mg dose (suspension or solution) once daily for 10 days.
16143065|NCT01835197|Drug|Placebo|Subjects will receive PF-04965842 matching placebo dose (suspension or solution) once daily for 10 days.
16143066|NCT01835184|Drug|cabozantinib-s-malate|Given PO
16143067|NCT01835184|Drug|vemurafenib|Given PO
16143068|NCT01835184|Other|laboratory biomarker analysis|Correlative studies
16143069|NCT01835184|Other|pharmacological study|Correlative studies
16143070|NCT01835158|Drug|Cabozantinib S-malate|Given PO
16143071|NCT01835158|Other|Laboratory Biomarker Analysis|Correlative studies
16143072|NCT01835158|Drug|Sunitinib Malate|Given PO
16143073|NCT01835145|Drug|Cabozantinib S-malate|Given PO
16143074|NCT01835145|Drug|Dacarbazine|Given IV
16143075|NCT01835145|Other|Laboratory Biomarker Analysis|Correlative studies
16143076|NCT01835145|Drug|Temozolomide|Given PO
16143077|NCT01835132|Device|Gevokizumab|Subcutaneous injection of 60 mg gevokizumab
16143078|NCT01835119|Drug|gum|gum
16143079|NCT01835106|Procedure|Epidural catheter is used postoperatively|
16143080|NCT01835106|Procedure|Fascia iliaca compartment catheter is used postoperatively|
16143081|NCT01835093|Drug|Tipepidine Hibenzate|
16143082|NCT01835067|Drug|Ranibizumab|Single intravitreal injection of 500 micrograms ranibizumab in 0.05mls
16143083|NCT01835067|Drug|C3F8 Gas|Single intravitreal injection of 0.3 mls C3F8
16143084|NCT01835067|Drug|tPA|Single intravitreal injection of 50 micrograms tPA in 0.05 mls
16143092|NCT01835041|Drug|6,8-bis(benzylthio)octanoic acid|Given IV
16143093|NCT01835041|Drug|oxaliplatin|Given IV
16143094|NCT01835041|Drug|leucovorin calcium|Given IV
16143095|NCT01835041|Drug|irinotecan hydrochloride|Given IV
16143096|NCT01835041|Drug|fluorouracil|Given IV
16143097|NCT01835041|Other|laboratory biomarker analysis|Correlative studies
16143098|NCT01835028|Other|Echocardiography|Observational Study using Imaging and Biomarkers
16143099|NCT01835028|Other|Computed tomography|Observational Study using Imaging and Biomarkers
16143100|NCT01835028|Other|Magnetic resonance imaging|Observational Study using Imaging and Biomarkers
16143101|NCT01835028|Other|Blood biomarkers|Observational Study using Imaging and Biomarkers
16143102|NCT01835028|Other|Stress echocardiography|Observational Study using Imaging and Biomarkers
16143103|NCT01835015|Drug|CLG561|Administered by intravitreal injection, Day 1
16143104|NCT01835002|Device|Transcorneal electrostimulation|Weekly stimulation for 30 minutes with current of TES delivered of 150% of the individual phosphene threshold.
16143105|NCT01834989|Drug|Insulin-like growth factor I|
16143106|NCT01834989|Drug|Placebo|
16143107|NCT01834963|Drug|Interferon Alfa、Fluorouracil|"Hepatic Arterial Infusion of 5-fluorouracil combined with systemic administration of Interferon-alpha
~Interferon Alfa 5×10⁶International Unit(IU)/body subcutaneously 3 times a week for 4 weeks
~Fluorouracil 300mg/m2, day1-5,8-12, every 6 weeks"
16143108|NCT01834963|Drug|Cisplatin、Fluorouracil|"Hepatic Arterial Infusion of 5-fluorouracil and Cisplatin (Low-dose FP)
~Cisplatin 20mg/m2 ,day1,8,22,29, every 6 weeks
~Fluorouracil 300mg/m2, day1-5,8-12,22-26,29-33, every 6 weeks"
16143109|NCT01834950|Other|Blood test|
16143110|NCT01834937|Device|ExAblate MRgFUS (Magnetic Resonance guided Focused Ultrasound Surgery)|Focused Ultrasound Surgery - FUS delivered by ExAblate for the palliation of pain due to bone metastases.
16143111|NCT01834924|Other|HELPix|Low literacy, bilingual (English/Spanish) medication instruction sheets used as a framework for provider medication counseling, plus provider dose demonstration, parent teachback/showback, provider medication log review, provision of oral dosing syringe to parent
16143112|NCT01834911|Drug|Tetrabenazine withdrawal|Tetrabenazine will be withdrawn for at least 3 days in Huntington disease patients currently on the drug. Patients will be examined via Stroop test in the OFF state. Two doses of 12.5 mg tetrabenazine will be introduced, spaced 3 hours apart. Stroop test will be performed 6 hours after initial OFF Stroop test.
16143113|NCT01834898|Drug|Controlled-release oxycodone|Controlled-release oxycodone. First day postoperatively, 40 mg / day divided into 20 mg of 12 in 12 hours and in the second postoperative day, 20 mg / day divided into 10 mg of 12 in 12 hours
16143114|NCT01834885|Drug|QVA149|QVA149 via inhaler twice a day
16143115|NCT01834885|Drug|fluticasone/salmeterol|fluticasone/slameterol via inhaler twice a day
16143116|NCT01834872|Device|Amigo|
16143117|NCT01834872|Device|Manual ablation|
16143118|NCT01834859|Behavioral|Multidisciplinary outpatient program|Diet (phase 1) and multidisciplinary lifestyle intervention (phase 2)
16143119|NCT01834859|Behavioral|Inpatient lifestyle program|Diet (phase 1) and lifestyle intervention (phase 2)
16143120|NCT01834846|Procedure|no-touch|The saphenous vein is exposed by a longitudinal incision, and all visible side branches ligated. The vein is then isolated together with a pedicle of surrounding tissue and manually distended and stored in a combination of blood and saline using a syringe, according to standard procedure at St. Olav's Hospital.
16143121|NCT01834846|Procedure|conventional|The saphenous vein is exposed by a longitudinal leg incision, skeletonized from surrounding tissue, and side branches ligated. The vein is removed from the leg immediately after dissection, manually distended and stored in a combination of blood and saline using a syringe, according to standard procedure at St. Olav's Hospital.
16143122|NCT01834833|Other|Follow-up|Evaluation by a cardiologist using echocardiography, completed by education of the patient if necessary
16143123|NCT01834820|Drug|Epinephrine and Dexamethasone|
16143124|NCT01834820|Drug|Hypertonic Saline|
16143125|NCT01834820|Drug|Normal Saline|
16143126|NCT01834794|Behavioral|MET/CBT/CM plus NRT|Behavioral Treatment for Cannabis plus Behavioral Treatment for Tobacco: both primarily delivered by computer. Additional NRT.
16143127|NCT01834781|Device|Pulsed electromagnetic fields|
16143128|NCT01834781|Device|w/o pulsed electromagnetic fields|
16143129|NCT01834768|Drug|Eplerenone|
16143130|NCT01834755|Other|Evaluation of psychological phenotype|
16143131|NCT01834742|Drug|NER1006|Single evening dose of 750mL solution containing 100g PEG3350 plus 6g sodium sulphate. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
16143132|NCT01834742|Drug|NER1006|Single evening dose of 750mL solution containing 100g PEG3350 plus 9g sodium sulphate. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
16143133|NCT01834742|Drug|NER1006|Single evening dose of 750mL solution containing 75g PEG3350 plus 5.6g sodium sulphate. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate, 20.1g ascorbic acid.
16143134|NCT01834742|Drug|Moviprep|Reconstituted and administered in accordance with recommended split dose intake: one litre in the evening, one litre the following morning.
16143135|NCT01834742|Drug|NER1006|Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350 and 56.6g sodium ascorbate.
16143136|NCT01834742|Drug|NER1006|Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350, 33.9g sodium ascorbate and 21.4g magnesium ascorbate.
16143137|NCT01834742|Drug|NER1006|Single evening dose containing formulation selected from Part A of study. Single morning dose containing 40g PEG3350, 6g sodium sulphate and 33.9g sodium ascorbate.
16143138|NCT01834742|Drug|NER1006|Single evening dose containing formulation selected from Part A of study. Single morning dose containing 29g PEG3350 and 4.8g sulphate and 23.3g ascorbic acid.
16143139|NCT01834729|Drug|Alfuzosin|oral alfuzosin immediate release (IR) 2.5 mg (Part A) or oral alfuzosin extended release (ER) 10 mg (Part B)
16143140|NCT01834729|Other|Placebo|placebo capsule identical to the study drug
16143141|NCT01834716|Behavioral|Aerobic vs. Non-Aerobic exercise|
16143142|NCT01834703|Procedure|UAE|The patient will be admitted into hospital for UAE. UAE was performed with patients under local anesthesia. Embosphere particles (BioSphere Medical) with a size of 500 - 700µm were used in all procedures. Embospheres were mixed with contrast material and saline and injected into each uterine artery until either parenchyma filling of the fibroids had stopped (target embolization) or the main uterine artery was blocked with stasis of contrast material (selective embolization). After the procedure, women were admitted to the gynecology ward for postprocedural care. All patients were advised to stay in the hospital for at least 1 night.
16143143|NCT01834703|Procedure|HIFU|Treatment will be given to the patient in one or more sessions on an outpatient basis. The uterine fibroid will be identified and located with ultrasonography and ablated with HIFU. For lesion beyond 6 cm distance from skin, HIFU is given at a power of 1200-1500 watt for 1500 - 2000 times at each spot, for 50 milli-second each time, at an interval of 100 milli-second, at a spot distance of 1.5cm, a line distance of 1.5cm, and a plane distance of 1.0 -1.5cm; for lesion within 6 cm distance from skin, HIFU is given at a power of 1300±15% Watt for 40 times at each spot, for120 milli-second each time, at an interval of 100 milli-second, at a spot distance of 0.3cm, a line distance of 0.3cm, and a plane distance of 0.8cm.
16143144|NCT01834664|Biological|stem cell (MNCs )|Intra thecal transplantation of autologous stem cell [MNCs ]Per dose at the interval
16143145|NCT01834651|Drug|Cabozantinib|Cabozantinib 60 mg daily (oral). Subjects may continue to receive study treatment until they experience unacceptable drug-related toxicity or disease progression.
16143146|NCT01834638|Drug|ABT-126|capsule(s)
16143147|NCT01834625|Diagnostic Test|PET scan|
16143148|NCT01834612|Device|CM1500|blood volume monitor
16143149|NCT01834599|Device|cerebral oximetry|tissue saturation measurement in pregnant women
16143150|NCT01834586|Drug|Anesthetic Topical Adhesive Synera|"For subjects taking interferon beta subcutaneous (Betaseron, Extavia or Rebif) apply one patch 60 minutes prior to each injection (every-other day or three times per week) for two weeks, then 30 minutes prior for two weeks.
~For subjects taking glatiramer acetate subcutaneous (Copaxone) apply one patch 60 minutes prior to each injection (daily) for one week and then 30 minutes prior for one week"
16143151|NCT01834573|Behavioral|physical exercise|10 weeks physical exercise; three times a week
16143152|NCT01834547|Drug|Drugs use: methylphenidate|40 mg tablets
16143153|NCT01834547|Drug|Drug use: modafinil|40 mg tablets
16143154|NCT01834547|Drug|caffeine|400 mg
16143155|NCT01834547|Drug|placebo|placebo
16143156|NCT01834534|Behavioral|CarePartners for depression|Automated telephone calls for depression monitoring and self-management support.
16143157|NCT01834521|Other|Web-based screening and tailored support|
16143158|NCT01834508|Drug|oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks|
16143159|NCT01834495|Device|Balloon expandable stent|provisional stenting should be performed; the case that optimal ballooning response in not obtained should be enrolled. Optimal balloon response is defined as a residual pressure gradient of > 15mmHg, residual stenosis of >30% and flow limiting dissection
16143160|NCT01834495|Device|Self expandable stent|provisional stenting should be performed; the case that optimal ballooning response in not obtained should be enrolled. Optimal balloon response is defined as a residual pressure gradient of > 15mmHg, residual stenosis of >30% and flow limiting dissection
16143161|NCT01834482|Dietary Supplement|Modified Atkins diet|Patients will receive the modified Atkins diet with a 20 gram per day carbohydrate limit and encouragement to consume plenty of fat and eat to satiety.
16143162|NCT01834482|Dietary Supplement|KetoCal|Patients will receive a KetoCal 4:1 ratio (fat: carbohydrates and protein) liquid daily for the first month (if randomized to this arm of the study). They will also be started on the modified Atkins diet.
16143163|NCT01834469|Drug|iv injection of ICG|An iv injection will be performed for the ovarian cancer patient before the operation.
16143164|NCT01834456|Other|Med Complex Children Intervention|Comprehensive Care, including creating a care plan, offering and integrating developmental and behavioral care, with added care coordination in a Medical Home/Primary Care Practice
16143165|NCT01834443|Device|Direct current galvanic vestibular stimulation|
16143166|NCT01834430|Dietary Supplement|enteral nutrition|
16143167|NCT01834417|Device|TexiMat|
16143168|NCT01834404|Drug|Phentermine-Topiramate ER|The dosing of the study drug was phentermine 3.75 mg / topiramate 23 mg days 1-5. The dosing of the study drug was increased to phentermine 7.5 mg / topiramate 46 mg days 6-14.
16143169|NCT01834404|Drug|Placebo|Placebo pills matched the study drug in appearance for the 2 dose levels.
16143170|NCT01834378|Behavioral|Low intensity intervention|We administer, a pedometer and the participants receive a prescription on physical exercise.
16143171|NCT01834378|Behavioral|High intensity intervention.|We schedule group sessions for changes in behavior e.g. type of physical activity to prefer, barriers for change of life style etc.
16143172|NCT01834365|Other|Structured education|Formatted education about hypertension
16143173|NCT01834365|Other|Checklist|
16143174|NCT01834365|Other|Without structure education with checklist|
16143175|NCT01834352|Drug|Walnut Protein Flour|Daily ingestion of gradually increasing amounts of walnut protein flour in order to induce desensitization to walnut and an unrelated tree nut.
16143176|NCT01834352|Drug|Oat flour|Oat flour that is administered as a placebo in identical increasing doses as the active walnut flour treatment.
16143177|NCT01834339|Biological|AlloDerm|
16143178|NCT01834339|Biological|EVPOME|
16143179|NCT01834326|Biological|EVPOME (autogenous ex vivo produced oral mucosa equivalent)|EVPOME is manufactured from the subjects own oral cells and is implanted back in the subjects mouth after an approximately 30 day manufacturing process.
16143180|NCT01834326|Biological|POM (Palatal oral mucosa)|POM is a tissue graft harvested from the palate and surgically placed into the defect area
16143181|NCT01834300|Behavioral|Unsupervised exercise training|The patients will be given lecture on lifestyle changes and its benefitial effects on health at the begining of the study by the exercise trainer. There will be no conatct with the exercise trainer for the period of intervention for 4 months.
16143182|NCT01834300|Behavioral|Supervised exercise training|Patients will be encouraged to exercise four times per week for 30-45 min at 60-80 % of maximal heart rate, with a 5 min warm-up and warm-down. Participants will be given free access to a variety of affiliated sports centres and will use the Wellness Key system, a software program that enables researchers to remotely track the exercise activity of participants very accurately. To ensure compliance with rest or exercise, all participants of both groups will have their mean physical activity level in 2 non-consecutive weeks evaluated with an ambulatory accelerometer.
16143183|NCT01834287|Behavioral|Physical Activity Intervention|Participants in the Physical Activity intervention arm of the study receive a Spanish language, motivationally-tailored, Internet-based Physical Activity intervention that specifically addresses the Physical Activity barriers and intervention needs/preferences of Latinas.
16143184|NCT01834287|Behavioral|Wellness Control|Participants will receive a Spanish language, Internet-based Wellness Contact control intervention addressing relevant health topics other than physical activity.
16143185|NCT01834274|Drug|Fasiglifam (TAK-875)|Fasiglifam (TAK-875) tablets
16143186|NCT01834274|Drug|Fasiglifam (TAK-875) Placebo|Fasiglifam (TAK-875) placebo-matching tablets
16143187|NCT01834274|Drug|Sitagliptin|Sitagliptin tablets
16143188|NCT01834274|Drug|Sitagliptin Placebo|Sitagliptin placebo-matching tablets
16143189|NCT01834274|Drug|Metformin|Metformin tablets
16143232|NCT01833910|Other|AHA CPR Anytime DVD|A CPR Training Video, originally developed as part of a kit, administered without the accompanying manikin.
16143190|NCT01834261|Drug|Syntocinon Nasal Spray, 40IU|Subjects will be scanned twice. Prior to first brain scanning session, they will be randomly assigned to receive either Syntocinon or Placebo. Prior to second scanning session, they will receive what they have not received in the first session; i.e., same subjects will be receiving both Syntocinon and placebo on two different days.
16143191|NCT01834261|Drug|Syntocinon Placebo Formulation, 40IU|Subjects will be scanned twice. Prior to first brain scanning session, they will be randomly assigned to receive either Syntocinon or Placebo. Prior to second scanning session, they will receive what they have not received in the first session; i.e., same subjects will be receiving both Syntocinon and placebo on two different days.
16143192|NCT01834248|Biological|DEC-205/NY-ESO-1 Fusion Protein CDX-1401|Given SC and ID
16143193|NCT01834248|Drug|Decitabine|Given IV
16143194|NCT01834248|Other|Laboratory Biomarker Analysis|Correlative studies
16143195|NCT01834248|Drug|Poly ICLC|Given SC
16143196|NCT01834235|Drug|Gemcitabine|Gemcitabine IV at a dose of 1000mg/m2 on days 1, 8, and 15 of a 4 week cycle.
16143197|NCT01834235|Drug|nab-paclitaxel|Nab-paclitaxel will be administered at a dose of 125 mg/m2 as a 30 minute infusion (maximum infusion time not to exceed 40 minutes) on Days 1, 7 and 15 for a 28 day cycle
16143198|NCT01834235|Drug|NPC-1C|NPC-1C(NEO-102) infusion at a dose of 1.5mg/kg IV on days 1 and 15 of a 28 day cycle. This will be administered 30 minutes after completion of the gemcitabine infusion.
16143199|NCT01834222|Biological|Non-intervention|Non-intervention
16143200|NCT01834209|Drug|Abiraterone acetate|Abiraterone 1000 mg (4 x 250 mg tablets) taken orally once daily for 28-day cycles
16143201|NCT01834209|Drug|Prednisone or prednisolone|5 mg tablet taken orally once daily
16143202|NCT01834196|Device|Swept-Source Optical Coherence Tomography|Noninvasive imaging of the retinal vasculature in patient with existing microvascular disease.
16143203|NCT01834183|Drug|Tivozanib|
16143204|NCT01834183|Drug|Gemcitabine|
16143205|NCT01834170|Drug|Gemcitabine|"Two intratumoral injections of gemcitabine under endoscopic ultrasound (EUS)-guidance at month 0 and month 3.
~The patients will receive systemic chemotherapy with or without radiotherapy at the discretion of oncologist"
16143206|NCT01834144|Other|Exercise Training|
16143207|NCT01834131|Behavioral|Comprehensive Intervention|The comprehensive intervention includes physician education, a community health worker home intervention and a mobile health intervention. Please see Arm Description for details.
16143208|NCT01834118|Procedure|Renal Denervation|Sympathetic nerve ablation via transcatheter renal denervation
16143209|NCT01834105|Drug|Liuwei Dihuang Pills|
16143210|NCT01834092|Other|Plasma|2 Units of plasma transfused equvilant to 2 times 275ml
16143211|NCT01834079|Biological|STEM CELL THERAPY|Autologous stem cells(MNCs ) intra thecal .Intra thecal transplantation of single arm autologous MNCs 100 millions per dose in 3 divided doses at interval of 7 days,Intrathecal/Intravenous .Follow up will be taken to three Months or as required
16143212|NCT01834066|Biological|Stem Cell|Intralesional transfer of Autologous Stem cell (MNCs) per dose. 6 doses in 3 months
16143213|NCT01834053|Biological|autologous Stem Cell|Intrathecal transplantation of autologous 100 millions Stem cells{MNCs } per dose'
16143214|NCT01834040|Other|Intralesional/ Intravenous of Autologous Stem cells.|Intralesional/ Intravenous of Autologous MNCs per dose
16143215|NCT01834027|Behavioral|Jazz music|Jazz music from artists including Miles Davis, Ella Fitzgerald, Nat King Cole, Dave Brubeck, etc. will be played through headphones for post-surgical hysterectomy patients while they are in the post anesthesia care unit.
16143216|NCT01834027|Behavioral|No music|In this group no music will be played in PACU
16143217|NCT01834014|Drug|Bevacizumab|5 mg/kg intravenously administered over 90 minutes (can be reduced to 30 minutes at the minimum) on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.
16143218|NCT01834014|Drug|Cetuximab|250 mg/m2 intravenously administered over 60 minutes (400 mg/m2 over 120 minutes as the initial dose) on day 1 and day 8 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.
16143219|NCT01834014|Drug|L-OHP|85 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.
16143220|NCT01834014|Drug|l-LV|200 mg/m2 intravenously administered over 120 minutes on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.
16143221|NCT01834014|Drug|5-FU|400 mg/m2 intravenous bolus on day 1 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.
16143222|NCT01834014|Drug|5-FU|2400 mg/m2 continuous infusion over 46 hours on day 1 and 2 of a 2-week cycle. Liver resection if resectable after 8 cycles or continue until progression of disease.
16143223|NCT01833988|Device|Bi-hormonal Bionic Pancreas|Automated blood glucose control via a closed-loop bionic pancreas device.
16143224|NCT01833988|Other|Usual Care|Comparator week to closed-loop control, utilizing usual camp care and the subject's own insulin pump.
16143225|NCT01833975|Biological|Transplantation of Autologous stem cell [MNCs] .|Intra thecal transplantation of Autologous stem cell [MNCs],100millions per dose in 3 divided doses at interval of 10 days.
16143226|NCT01833949|Procedure|Unilateral laparoscopic drilling|Unilateral laparoscopic drilling with diathermy adjusted to ovarian volume
16143227|NCT01833949|Procedure|Bilateral laparoscopic drilling|Bilateral laparoscopic drilling with fixed doses energy
16143228|NCT01833936|Device|Compex® muscle stimulator|The Compex® muscle stimulator is a commercially available muscle stimulator that is approved by the Food and Drug Administration (FDA), a governmental body. It is not investigational. The investigational part of this study aims to evaluate if the use of muscle simulation after Achilles tendon surgery will reduce calf atrophy.
16143229|NCT01833936|Device|(inactive) muscle stimulator|A placebo (inactive) muscle stimulator, which will be placed immediately following surgery. Eight electrodes will be placed on the lower leg: four electrodes on the gastrocnemius (calf muscle), and two electrodes each on the lateral gastrocnemius (side) and anterior tibialis muscle (front). Subjects will be instructed to use the stimulator for three 20 minute sessions per day.
16143230|NCT01833923|Drug|anlotinib|oral medicine.
16143231|NCT01833910|Other|AHA CPR Anytime Video Self-Instruction Kit|CPR Training utilizing a video self-instruction kit including training video and inflatable manikin.
16143233|NCT01833897|Drug|Standard of Care|Quetiapine, olanzapine-fluoxetine, and lurasidone are approved treatments for bipolar depression. Quetiapine dosing will follow the product label(Anon), and will be titrated over the first 4 days to the target dose of 300 mg. Olanzapine-fluoxetine dosing will also follow standard guidelines. Lurasidone will be started at 20 mg, and titrated up to 60 mg daily as clinically indicated. Study physicians will use clinical judgment to choose between standard-of care treatments, and have the option to titrate standard-of-care within approved ranges, and to prescribe adjunctive benztropine and benzodiazepines if clinically indicated.
16143234|NCT01833897|Drug|Ketamine|Ketamine administration will be carried out according to the methods as described by previous studies. Subjects will receive ketamine hydrochloride (0.5 mg/kg) intravenously during 40 minutes. This dosage was selected based on previous trials of ketamine for the treatment of refractory depression and bipolar depression. Vital signs (blood pressure, heart rate) will be closely monitored throughout the time of infusion. Subjects will be evaluated for 2 consecutive days during this phase; i.e. treatment days (day 1) and rating days (day 2). Non-responders to ketamine will not proceed into the DCS phase. Response will be a 25% improvement on the Hamilton Depression Rating Scale (HDRS).
16143235|NCT01833897|Drug|D-cycloserine|Immediately after the ketamine infusion, subjects will begin an eight-week treatment of DCS adjunctive to standard of care. DCS dosing will begin at 250 mg for three days→500mg (2 capsules)/day for 1 week → 750 mg (3 capsules)/day for 1 week → and 1000 mg (4 capsules)/day for the remainder of the study.
16143236|NCT01833884|Other|Collection of blood specimen|Collection of blood specimen for Cytokines dosing scheduled before , during and after treatment of Hodgkin's lymphoma (last collection date about 90 days after the end of treatment)
16143237|NCT01833871|Other|Three dimensional Power Doppler to the myometrial mass|Trans-vaginal 3D power Doppler Ultrasonographic examination will be done for all participants prior to surgery. The ultrasonographic examination will provide data related to lesion size, lesion volume, vascular location (location), vascular index (VI), flow index (FI), and vascular-flow index (VFI). The region of interest will include the entire region of the uterine mass. The virtual organ computer aided analysis (VOCAL) software for the analysis of 3D power Doppler histograms will be used with computer algorithms to form indices of blood flow and vascularization. All data will be collected and compared with the post operative histopathology results.
16143238|NCT01833871|Other|Uterine artery Doppler|uterine artery Doppler indices(RI,PI) are measured for all cases with myometrial mass
16143239|NCT01833858|Drug|Low dose HCG|Low dose hCG (200 IU per day) will be given daily when at least six follicles of 12 mm will be observed and E2 (Estradiol) levels are higher than 600 ng/l, until the day of the HCG trigger administration.
16143240|NCT01833858|Drug|Placebo|Patients received rFSH injections with Placebo starting on cycle day 3 of the stimulation cycle until the day of hCG trigger administration.
16143241|NCT01833845|Drug|Ribavirin|weight-based doses (1000 mg/day administered BID [twice daily] for subjects ≤ 75 kg and 1200 mg/day administered BID for subjects > 75 kg). Those subjects receiving 1000 mg/day RBV will take 2 tablets of 200 mg/tablet in the morning and 3 tablets in the evening, and those subjects receiving 1200 mg/day RBV will take 3 tablets morning and evening.
16143242|NCT01833845|Drug|Hydroxychloroquine|subjects will receive HCQ 575 mg administered as a single tablet once daily (QD)
16143243|NCT01833832|Drug|Cisplatin|Patients who are successfully debulked will then undergo hyperthermic intraperitoneal chemotherapy (HIPEC) with cisplatin.
16143244|NCT01833832|Procedure|Cytoreductive surgery|Patients will undergo cytoreductive surgery to achieve a Completeness of Cytoreduction Score (CC) of 0 or 1.
16143245|NCT01833832|Drug|sodium thiosulfate|sodium thiosulfate will be given to limit the toxicity of cisplatin
16143246|NCT01833819|Drug|Dexmedetomidine and lidocaine|
16143247|NCT01833819|Drug|Remifentanil|
16143248|NCT01833806|Device|ExAblate MRgFUS|Focused Ultrasound Ablation
16143249|NCT01833793|Drug|Levonorgestrel IUD (Mirena, BAY86-5028)|Women who have been prescribed Mirena in contraception; followed up for 12 months
16143250|NCT01833767|Drug|Cyclophosphamide and Interleukin 2|Cytoxan IV day 1, IL2 IV days 1-5
16143251|NCT01833754|Drug|Romosozumab|Administered as three 70 mg/mL prefilled syringe injections
16143252|NCT01833741|Drug|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® RC) administered as one drop in the study eye(s) each evening for 12 weeks.
16143253|NCT01833728|Drug|nefopam-propacetamol combination|"Patients in both groups will receive intravenous patient-controlled analgesia (PCA) using fentanyl.
~In nefopam-propacetamol combination group, patients will receive nefopam(20mg mixed to normal saline 100mL) and propacetamol(2g mixed to normal saline 100mL), 30 minutes before the end of operation, every 6 hours for up to 48 hours."
16143254|NCT01833728|Drug|propacetamol alone|In propacetamol alone group, patients will receive placebo (normal saline 2 ml mixed to normal saline 100mL) and propacetamol(2g mixed to normal saline 100mL), 30 minutes before the end of operation, every 6 hours for up to 48 hours.
16143255|NCT01833715|Drug|Morphine|Morphine group,receive morphine 0.08 mg / kg at the start of surgery
16143256|NCT01833715|Drug|Methadone|Methadone group,receive methadone 0.08 mg / kg at the start of surgery
16143257|NCT01833715|Drug|TIVA|TIVA: General anesthesia will be based on Remifentanil and Propofol (TIVA-TCI), titrated to achieve bispectral index (BIS) between 40 and 60.
16143258|NCT01833689|Dietary Supplement|food consumption|"Reference food The reference food is 50 g glucose powder dissolved in 250ml water
~Test foods The test foods are prepared according to manufacturer's instructions, representing the food as normally consumed. The test foods are consumed once only on separate occasions as a portion providing 50g of available carbohydrate.
~Breakfast cereals should be consumed with 150 ml milk which is additional to the 50 g available carbohydrate in the cereal. In testing breakfast cereals, the reference food must also be consumed with an additional 150 ml milk."
16143259|NCT01833676|Drug|Sevoflurane|
16143260|NCT01833676|Drug|Desflurane|
16143261|NCT01833663|Drug|Solifenacin Succinate Tablets|
16143262|NCT01833663|Drug|Estrogen|
16143263|NCT01833650|Dietary Supplement|thymus honey mouthwash|
16143369|NCT01832727|Drug|Oprozomib|Oprozomib tablets were supplied containing 60, 90, or 120 mg of oprozomib. Oprozomib extended release tablets were supplied containing 150, 180, 210, 240, or 270 mg of oprozomib. Both formulations were administered in a single dose on dosing days. The tablet formulation required multiple tablets to reach each dose on dosing days.
16143264|NCT01833637|Other|APN Intervention|Patients randomized to this group will be asked to fill out a patient symptom assessment using an iPad at the time of registration and then every day until released from the hospital. It should take about 10 minutes to complete this questionnaire each time. Based on the patients' answers and in cooperation with their health care provider, an Advanced Practice Nurse (APN) will provide information about symptom management and options for services that are available after the patient leaves the hospital. The survey responses will be shared with the patients' healthcare team so that they better understand how they are feeling. The APN will work closely with the healthcare team. Patients will be asked to fill out a Patient Satisfaction Questionnaire at the time of discharge.
16143265|NCT01833624|Dietary Supplement|Peptamen® AF|Comparison of two types of enteral nutrition feeding: Peptamen® AF and Sondalis® HP
16143266|NCT01833624|Dietary Supplement|Sondalis® HP|
16143267|NCT01833611|Drug|Entecavir|entecavir 0.5mg qd
16143268|NCT01833611|Drug|placebo|placebo qd
16143269|NCT01833598|Procedure|PNT + PRP|The PNT + PRP group will undergo needle tenotomy under direct and continuous ultrasound guidance with even distribution of PRP into the peritendinous area(s) of PNT around the affected tendon.
16143270|NCT01833598|Procedure|PNT alone|The PNT group will undergo needle tenotomy under direct and continuous ultrasound guidance local anesthesia into the affected tendon. 10 minutes after the injection, the ultrasound machine probe will be passed over the areas treated both to evaluate for any structural changes and for any complications.
16143271|NCT01833585|Biological|Peripheral blood mononuclear cell|Peripheral blood mononuclear cell solution 59 cc will be injected to the gastrocnemius muscle of ischemic limb of patients with critical limb ischemia
16143272|NCT01833572|Drug|Gefitinib|Eligible participants will be given orally gefitinib 250mg daily before surgery for 42 days or until disease progression or unacceptable toxicity. Best supportive care is allowed in this period.
16143273|NCT01833559|Dietary Supplement|Dietary control|
16143274|NCT01833559|Drug|Insulin|If feast blood glucose is over 7.0 mmol/L, the patient will be hospitalized and insulin will be used. The kind of insulin used depends on the need of patients.
16143275|NCT01833546|Drug|Evofosfamide|Evofosfamide infusion intravenously at an escalated dose of 240, 340 or 480 milligram per square meter (mg/m^2) on Day 1, 8 and 15 of each 28-day treatment cycle until progressive disease, unacceptable toxicity or withdrawal.
16143276|NCT01833546|Drug|Gemcitabine|Gemcitabine 1000 mg/m^2 on Day 1, 8 and 15 of each 28-day treatment cycle until progressive disease, unacceptable toxicity or withdrawal.
16143277|NCT01833533|Drug|ABT-450/r/ABT-267, ABT-333|Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
16143278|NCT01833533|Drug|Ribavirin|Capsule
16143279|NCT01833533|Drug|Placebo for Ribavirin|Capsule
16143280|NCT01833520|Drug|Ra-223 Dichloride|"Phase I Starting Dose of Ra-223 Dichloride: 50 kBq/kg by vein over several minutes on Day 1 of each 4-week cycle.
~Phase II Starting Dose of Ra-223 Dichloride: MTD from Phase I."
16143281|NCT01833507|Behavioral|Self-Exercise|Behavioral Goal Setting
16143282|NCT01833507|Behavioral|Usual Care|Participants will have full access to all of the educational materials which are available to all Mayo Clinic patients in literature racks in the individual clinics. Participants will subsequently be given entry into the active intervention at the 2-month check.
16143283|NCT01833494|Drug|PA21|
16143284|NCT01833481|Radiation|Fluoroscopy surveillance of patients while walking|While each subject performs a gait activity (normal walking) under fluoroscopic surveillance on a level treadmill, a data acquisition (DAQ) system will be used to determine the vibrations/sounds occurring during walking.
16143285|NCT01833455|Drug|PVC Suppression using Flecainide|Flecainide will be administered to result in a reduction in PVC burden.
16143286|NCT01833455|Drug|No PVC Suppression using Placebo|Placebo (sugar pills) will be given to result in no alteration in PVC burden.
16143287|NCT01833442|Behavioral|Kundalini Yoga Meditation|The trial will compare two very different meditation protocols. After the 4.5 month the patients will be reevaluated, and all patients will be merged together into a single group. Patients will then receive 9 - 12 more months of the meditation protocol.
16143288|NCT01833442|Behavioral|Relaxation Response Meditation|The trial will compare two very different meditation protocols. After the 4.5 month the patients will be reevaluated, and all patients will be merged together into a single group. Patients will then receive 9 - 12 more months of the meditation protocol.
16143289|NCT01833403|Other|Hyperinsulinemic-euglycemic clamp|"Subject will received 6,6 2H2 Glucose prior and during a 4 hr hyperinsulinemic-euglycemic clamp to characterize hepatic insulin resistance prior to bariatric surgery
~--------------------------------------------------------------------------------"
16143290|NCT01833390|Drug|HXe MRI lung ventilation|MagniXene (HXe) is an Investigational New Drug made of xenon noble gas. Through a physical process using alkali vapors and powerful lasers, xenon atoms have their nuclear spin preferentially aligned (hyperpolarized), thus offering a highly enhanced signal inside an MRI scanner. High-resolution images of the lung spaces are acquired within a short breath-hold after inhalation of HXe.
16143291|NCT01833377|Dietary Supplement|caraway sample|
16143292|NCT01833377|Dietary Supplement|placebo|
16143293|NCT01833364|Procedure|Implantation of the Peripheral Nerve Graft|"The preparatory surgery for harvesting the peripheral nerve graft will take place in the operating room at the time of the Stage I surgery for the DBS procedure. The nerve exposure and preparation will take approximately 15 minutes of operating time in addition to the DBS procedure which typically takes 75-90 minutes.
~The implantation of the nerve graft will take place in the operating room at the end of the second stage surgery for DBS. The graft harvesting and implantation will take approximately 15 minutes in addition to the 4 hours that is needed for the DBS surgery. The subject's peripheral nerve graft will be implanted into the substantia nigra unilaterally. This is a single arm trial to assess safety and feasibility."
16143294|NCT01833351|Drug|IV Vitamin C|"We will begin by enrolling 3 people at each dose level and if there are any problems seen, we will enroll 3 more people to that dose to see if that problem happens again and this may total a maximum of 6 people. Therefore a maximum of 6 people may be enrolled at each of these Vitamin C dose levels, 1 gram, 5 grams, 10 grams, 25 grams, 50 grams, 75 grams, and 100 grams.
~If you are eligible for the study and decide to participate, the total time involved could be approximately 4 weeks."
16143439|NCT01832012|Other|Multimedia|AHA specific BLS refresher video, 7 minutes in length.
16143295|NCT01833351|Drug|IV Vitamin C|"There will be 4 dose levels of intravenous vitamin C selected for this part of the study. The first dose level will be 25% of the top dose level found to be safe in Part 1, followed by 50% of the top dose level, followed by 75% of the top dose level, and finally 100% of the top dose. For example, if 100 grams of vitamin C given by vein is found to be safe in Part 1, then the first dose level we will choose will be 25 grams, followed by 50 grams, then 75 grams, and finally 100 grams.
~Three to 6 people will be invited to participate in each of the dose levels and you will be asked to get a total of 4 doses at that level spread out over 4 weeks. In addition, you will have an initial visit and a follow-up visit both lasting 30 minutes. This will total 6 visits."
16143296|NCT01833338|Device|Imaging|All patients undergo non-invasive (MSCT) and invasive (IVUS, OCT) imaging
16143297|NCT01833325|Radiation|Proton radiation|Proton radiation given to a total dose of 24 cobalt gray equivalent (CGE) in 2 treatments
16143298|NCT01833312|Device|Hypothermia|In patients randomised to therapeutic hypothermia, induction of cooling will be started by infusion of 4°C isotone saline or Ringer's lactate administered over a period of 30 to 60 minutes. A body temperature between 34.0 and 35.0°C will be targeted. Body temperature will be monitored through bladder or rectal thermal probes, and cooling procedures will be adapted to keep body temperature as close as possible to the target. Maintenance of body temperature in the target range will be performed with a surface or endovascular cooling device. After a cooling period of 24h, controlled rewarming to 36°C with a rate of 0.2°C/h will be started. After 36°C have been reached, the device will be disconnected.
16143299|NCT01833312|Drug|Buspirone|anti-shivering treatment
16143300|NCT01833312|Drug|Pethidine|anti-shivering treatment
16143301|NCT01833299|Procedure|TACE-Sorafenib group|"Transcatheter arterial chemoembolization drugs and dosage:TACE with chemothrapy drugs (E-ADM 50mg, carboplatin 300 mg, MMC 8mg)and followed with embolization with lipiodol and absorbable gelatin sponge particles or polyvinyl alcohol particles.
~Oral sorafenib (400 mg BID) will be start the 2-4 weeks after the first TACE treatment and will continue until the patient shows disease progression, until unacceptable toxicity occurs, or until study termination."
16143302|NCT01833299|Procedure|TACE|
16143303|NCT01833286|Procedure|TACE+RFA|TACE first, followed by RFA within 2 months
16143304|NCT01833286|Procedure|re-resection|repeat hepatectomy for recurrent small HCC
16143305|NCT01833273|Drug|PolyMVA|Subjects will take 8 tsp/day of PolyMVA over a 26 week period while receiving standard of care from his/her neuro-oncologist. Subjects will begin taking the study compound after maximal surgical resection of the tumor and receiving an initial treatment of radiation therapy. Subjects will not take study compound on days when they receive chemotherapy.
16143306|NCT01833260|Behavioral|Music|
16143307|NCT01833234|Other|Interviews and questionnaires|
16143308|NCT01833221|Drug|injection of 1% lidocaine, 2mL for facial nerve block|injection with a fine needle of 2mL lidocaine in close contact of the facial nerve trunk
16143309|NCT01833208|Other|Laboratory Biomarker Analysis|Correlative studies
16143310|NCT01833208|Radiation|Radiation Therapy|Undergo single-fraction radiation therapy
16143311|NCT01833182|Other|Tailored home intervention|The occupational therapist (OT) interventionist will develop a set of environmental modification choices to improve performance in problematic activities identified during the clinical evaluation. A plan for resolving the barriers identified during clinical assessment will be developed. The participant will review the barrier removal options and will make an informed choice resulting in a final treatment plan. Modification installation which will be provided, at no cost to the participant, by a contractor trained by the study PI. The tailored intervention includes training in the use of the new equipment or architectural changes. Photographs of identified barriers, study measures, and intervention plans will be reviewed by the principal investigator during team meetings to ensure treatment fidelity.
16143312|NCT01833182|Other|Sham intervention|We have developed a kit containing 12 standard adaptive equipment (AD) items (e.g., jar opener). The AD kit has been specifically designed to address fine motor function and will not influence fall outcomes. Two pieces of AD will be provided during each session, and the individual will be instructed to use each AD by the OT interventionist
16143313|NCT01833169|Drug|BKM120|BKM120 100 mg (oral gelatine capsules) was administered orally once daily starting from cycle 1 day 1 and will be dosed continuously every day for each 28-day cycle
16143314|NCT01833156|Device|MoistureMeterD|measuring erythema size and the dielectric constant values
16143315|NCT01833143|Drug|Bortezomib|
16143316|NCT01833143|Drug|Acyclovir|
16143317|NCT01833130|Biological|OnabotulinumtoxinA|OnabotulinumtoxinA (botulinum toxin Type A) 155 U total dose per treatment injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
16143318|NCT01833130|Drug|Normal saline (placebo)|Placebo (Normal saline) injected into specified head and neck muscles on Day 1 followed by a second treatment at Week 12.
16143319|NCT01833117|Other|FID 119515A|topical ocular drops
16143320|NCT01833117|Other|Blink® Tears|topical ocular drops
16143321|NCT01833104|Behavioral|Presence - Perspective - Affect|"PRESENCE: Cultivate attentional skills & interoceptive body awareness. 2 exercises: Breathing Meditation & Body Scan.
~PERSPECTIVE: Focus on cognitive aspects of compassion; take perspectives on thoughts, the self, & other people; observe more macroscopic dynamics within oneself, your inner parts; do not fully identify with them / be aware of their transiency; strengthen the ability to detach from one's own perspective, take the perspectives of others, trying to understand their thoughts, motives, feelings. 2 exercises: Observing-thoughts Meditation & Perspective Dyad.
~AFFECT: Cultivate emotional/motivational aspects of compassion; cultivate a sense of benevolence, love, care, opening the heart for oneself and others; work with obstacles, e.g. fear, anger or sadness (emotion acceptance); pro-social motivations as an alley towards loving / benevolent feelings and as a consequence of them. 2 exercises: Loving-kindness Meditation & Affect Dyad."
16143322|NCT01833104|Behavioral|Presence - Affect - Perspective.|As specified above however the order is interchanged between the cohorts TC1 and TC2.
16143323|NCT01833104|Behavioral|Affect|"AFFECT: Cultivate emotional/motivational aspects of compassion; cultivate a sense of benevolence, love, care, opening the heart for oneself and others; work with obstacles, e.g. fear, anger or sadness (emotion acceptance); pro-social motivations as an alley towards loving / benevolent feelings and as a consequence of them. 2 exercises: Loving-kindness Meditation & Affect Dyad."
16143440|NCT01832012|Other|Hands-on practice|Hands-on BLS CPR practice on a Laerdal BLS manikin.
16143324|NCT01833091|Other|artificial night|Infants in the intervention group received light cyclic with pattern 12 hours. Light period was from 7 to 19 during which the infants were put in the normal environmental light and dark period was from 19 to 7 during which was the infants' incubator was covered with linen cloth. The vital signsand & arterial oxygen saturation of the infants in the intervention group were controlled before covering the incubator i.e. at 19. Also, the infant's vital signs were again monitored at 7 am.The infant weighed in every day at 7 am during the 10 days of study. Feeding tolerance was daily determined at 8 am, using nasogastric tube or orogastric tube to control residue as well as to review the presence or absence of abdominal distention, vomiting.
16143325|NCT01833078|Drug|ghrelin|ghrelin administration subcutaneously for 7 days
16143326|NCT01833065|Drug|Elobixibat 10 mg/day|Elobixibat 10 mg/day
16143327|NCT01833065|Drug|Elobixibat 5 mg/day|Elobixibat 5 mg/day
16143328|NCT01833065|Drug|Placebo|Placebo
16143329|NCT01833052|Device|TAVI (Medtronic CoreValve)|
16143330|NCT01833052|Device|Claret-Filter|
16143331|NCT01833039|Drug|Ibrutinib|Ibrutinib
16143332|NCT01833026|Device|Spirometry test|For the initial visit for the intervention group, an initial demographics form and a health questionnaire will given to the subject to complete. To evaluate the breathing and quality of living, a spirometry test will be performed that will evaluate how well and how fast the subject can breath and blow out air.
16143333|NCT01833026|Drug|Levalbuterol|The spirometry test will be performed with a breathing medication called Levalbuterol (Xopenex®). Levalbuterol is used in standard practice for COPD and is commonly used during spirometry.
16143334|NCT01833013|Other|live birth date and quality of life assessment|
16143335|NCT01833000|Device|Cerebral and splanchnic ear infrared spectroscopy (NIRS) and mesenteric Doppler|
16143336|NCT01832987|Drug|co-trimoxazole|On 4, 5 or 6 consecutive days, co-trimoxazole 960 mg will be added to the normal treatment regimen
16143337|NCT01832974|Drug|IL-13-PE|IL-13-PE intravenous infusion
16143338|NCT01832961|Device|Flutter valve exercises|30 minutes of flutter exercises
16143339|NCT01832961|Device|Flutter Sham exercises|30 minutes of flutter-sham exercises
16143340|NCT01832961|Device|Flutter and bronchodilator exercises|Flutter + bronchodilator exercises with an interval of 3 to 5 days
16143341|NCT01832948|Drug|Endostar|
16143342|NCT01832948|Drug|Oxaliplatin|
16143343|NCT01832948|Drug|Folinic acid|
16143344|NCT01832948|Drug|5-FU|
16143345|NCT01832935|Drug|insulin glargine|The starting dose of insulin Glargine was 24 units per day (0.2-0.6 unit/kg) in 2 divided doses
16143346|NCT01832935|Drug|Insulin NPH|The starting dose of insulin NPH was 24 units per day (0.2-0.6 unit/kg) in 2 divided doses
16143347|NCT01832922|Drug|Bendamustine|
16143348|NCT01832922|Drug|Rituximab|
16143349|NCT01832909|Other|Walnut Diet|Controlled diet with 1.5 oz/d of walnuts.
16143350|NCT01832909|Other|Control Diet|Controlled diet without walnuts.
16143351|NCT01832896|Drug|Ecallantide subcutaneous dosing|For acute attacks of Hereditary Angioedema in children and adolescents, Ecallantide will be administered.
16143352|NCT01832883|Device|Pediatric Vision Scanner|Subject is scanned with a 2.5 second pediatric vision scanner device test.
16143353|NCT01832870|Drug|sipuleucel-T|
16143354|NCT01832870|Drug|ipilimumab|
16143355|NCT01832857|Drug|CPI-613|CPI-613 drug product, provided in concentrated form at 50 mg/mL, must be diluted with D5W prior to administration. CPI-613 is to be infused intravenously (IV) via a central venous catheter. CPI-613 will be given 2x weekly, administered on Days 1 and 4 of each of the 3 treatment weeks, followed by a week of rest. The dose of CPI-613 will be 3,000 mg/m2 infused IV over 2 hours (this is the maximum tolerated dosing [MTD]), via a central venous catheter with D5W running at a rate of about 125-150 mL/hr.
16143356|NCT01832844|Procedure|"Group  with scan prior to infiltration "|Scan will be conducted by the operator performing the gesture. He will examine the lumbar spine from L3 to S1, in longitudinal and cross sections and determine the best surgical approach. This will be defined by the largest interspinous space or better visibility of the epidural space. The depth of the epidural space will be noted. The selected stage will be marked with a skin pen to facilitate its location thereafter
16143357|NCT01832844|Procedure|"Group  without scan "|
16143358|NCT01832818|Device|NuNec Cervical Disc|Patients will be enrolled and implanted with the NuNec device at a single level C3 to C7.
16143359|NCT01832805|Other|Theta burst stimulation.|In each session, subjects will receive 54 Theta burst trains of 2 seconds duration, separated by an intertrain interval of 18 seconds, delivered on the left dorsolateral prefrontal cortex (DLPFC). The treatment protocol of in total 20 Theta burst sessions will be spread over 4 days, yielding a total of 32400 stimuli. On each stimulation day, a given patient shall receive 5 sessions with a between session delay of 10 to 15 minutes.
16143360|NCT01832792|Other|Face-to-face self-help|Participants in this arm will receive face-to-face self-help; that is, self-help with the support of a therapist, attending the clinic in person.
16143361|NCT01832792|Other|E-mail self-help|Participants in this arm will receive e-mail self-help; that is, self-help with the support of a therapist, provided via e-mail.
16143362|NCT01832792|Other|Waiting List|Waiting list condition - participants assigned to a waiting list (no intervention) condition
16143363|NCT01832779|Other|Achalasia subjects|Information about the subject's medical history, leading up to the need for an Achalasia treatment, the procedure itself and how the subject does after the procedure, including after the subject's gets home, will be collected. This will be done by gathering relevant information from the subject's medical chart and/or by talking with the subject prior to and after your medical procedures. There are no specific study procedures or tests. All information collected is part of the subject's medical care and will be collected even if the subject is not in the study.
16143364|NCT01832766|Drug|Dronabinol|dronabinol 10 mg one capsule by mouth at 8:00 a.m.
16143365|NCT01832766|Other|Placebo Comparator|one capsule given by mouth at 8:00 a.m.
16143366|NCT01832753|Drug|Levothyroxine|
16143367|NCT01832740|Device|brain stimulation|oscillating direct current brain stimulation
16143368|NCT01832740|Device|SHAM|no stimulation
16143485|NCT01831596|Device|ciSNaP|SNaP disposable, mechanically powered Negative Pressure Wound Therapy System
16143612|NCT01830699|Drug|Corticosteroid|2 cc (40 mg/mL) triamcinolone intra-bursal once
16143370|NCT01832727|Drug|Dexamethasone|Dexamethasone was administered as 20 mg tablets in strengths of 4 and 6 mg taken orally. If a participant could not tolerate tablets or tablets were unavailable, 20 mg administered intravenously was substituted.
16143371|NCT01832701|Other|Coffee|coffee versus placebo
16143372|NCT01832701|Other|Placebo comparator|maltodextrine with caffeine
16143373|NCT01832688|Other|Programmatic prenatal care optimization|To further integrate and improve nutrition-related services and messages in the prenatal care package.
16143374|NCT01832675|Drug|Xylocain, cutaneous spray, solution|10 mg lidocaine/spray. The patient will be sprayed three times and get a maximal dose of 30 mg lidocaine just before the examination.
16143375|NCT01832675|Drug|Bupivacaine lozenge|25 mg bupivacaine/lozenge. The patient will get one lozenge 10-15 minutes before the examination.
16143376|NCT01832662|Other|coffee|coffee, placebo enriched with polyphenols and placebo with caffeine
16143377|NCT01832662|Other|coffee polyphenols mixed with placebo|coffee polyphenols mixed with placebo
16143378|NCT01832662|Other|maltodextrin enriched with caffeine|maltodextrin enriched with caffeine
16143379|NCT01832649|Behavioral|Exercise|Supervised moderate-vigorous exercise in group, based on strength and calisthenics exercises, 2 times per week during 8 weeks.
16143380|NCT01832649|Behavioral|Health education|Supervised groups 2 times per week during 8 weeks.
16143381|NCT01832636|Dietary Supplement|Alanyl-Glutamine|Alanyl-Glutamine and Glycine doses will be prepared immediately prior to administration by dissolving in formula, milk, or fruit juice. Administration of each dose will be directly observed by a study nurse or health agent.
16143382|NCT01832623|Other|Exploration of Vitamin D roles|"Visit 1: questioning, physical examination, blood sampling (including plasma collection for future genetic analyses), carotid ultrasound
~Visit 2 (same day as visit 1 or maxi 3 months later): HR-pQCT, dual energy x-ray absorptiometry (DXA), iontophoresis of acetylcholine and sodium nitroprusside"
16143383|NCT01832610|Device|HeartWare® VAS|The HeartWare® LVAD is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device which is both lightweight and simple to use.
16143384|NCT01832584|Dietary Supplement|RGC|
16143385|NCT01832584|Dietary Supplement|Placebo|
16143386|NCT01832571|Drug|Once daily Truvada®|At the enrollment visit, participant's eligibility is assessed per protocol and she is provided with a 30 day supply of Truvada and instructed to take one tablet orally once daily with or without food. Each tablet contains 200 mg emtricitabine (FTC) and 300 mg tenofovir disoproxil fumarate (TDF). Participants will receive Truvada at each clinic visit after it is confirmed that she is HIV negative. There will be a 1 month follow-up visit after enrollment. Thereafter, participants will have quarterly visits until April 2014.
16143387|NCT01832558|Drug|Eplerenone|
16143388|NCT01832558|Drug|Placebo|
16143389|NCT01832545|Other|Aquatic Exercise|
16143390|NCT01832545|Behavioral|Educational Program|Control Group
16143391|NCT01832532|Drug|liraglutide|daily use of drug. Titrated up from 0.6mg/day to 1.8mg/day or highest tolerated dose
16143392|NCT01832506|Drug|MSC2156119J|Subjects will be administered with MSC2156119J 215 mg, 300 mg and 500 mg orally once daily for repeated 21-day cycles until disease progression or unacceptable toxicity.
16143393|NCT01832493|Device|Cardiac Resynchronization Therapy|All study patients were evaluated for the optimal atrial-ventricular (AV) programmed interval using various methods.
16143394|NCT01832480|Drug|MTZ 500 mg twice daily x 7 days|MTZ 500 mg twice daily x 7 days
16143395|NCT01832480|Drug|MTZ 2 g|MTZ 2 g
16143396|NCT01832467|Drug|cetuximab-containing chemotherapy|
16143397|NCT01832454|Other|Intra thecal inj of autologous MNC|Intra thecal inj of autologous MNC
16143398|NCT01832441|Other|Intra thecal transplantation of autologous MNC|Intra thecal inj.of 100 millions MNC in 3 doses at 7 days interval
16143399|NCT01832428|Other|Intra thecal transplantation of Autologous Stem Cells|Intra thecal transplantation of Autologous Stem Cells
16143400|NCT01832415|Drug|Bevacizumab|Observation of bevacizumab administration in first line ovarian cancer treatment
16143401|NCT01832402|Drug|Fentanyl Pectin Nasal Spray|Fentanyl pectin nasal (FPNS) dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) administered intranasally 20 minutes before the second 6-minute walk test. Same dose repeated at least 30 minutes after the first dose and 20 minutes prior to the third and final 6 minute walk test.
16143402|NCT01832402|Drug|Placebo Nasal Spray|Placebo nasal spray administered intranasally 20 minutes before the second 6-minute walk test. Same dose repeated at least 30 minutes after the first dose and 20 minutes prior to the third and final 6 minute walk test.
16143403|NCT01832402|Other|Walk Test|Walk test administered before first dose of drug/placebo nasal spray. Participant will rest for 30 minutes after walk test. Drug/placebo nasal spray administered, then participant will wait 20 minutes before repeating second 6 minute walk test. After second walk test, participant will rest for 30 minutes. Drug/placebo nasal spray administered for second time, then participant will wait for 20 minutes. Walk test administered again for 6 minutes.
16143404|NCT01832402|Behavioral|Questionnaires|Questionnaires completed at baseline, before each walk test, and at end of final walk test.
16143405|NCT01832402|Behavioral|Mental Ability Tests|Four mental ability tests administered after each walk test to include finger tapping, simple mathematics questions, recall of numbers, and recall of objects.
16143406|NCT01832389|Device|PiCCO|
16143407|NCT01832376|Procedure|Ultrasound guided needle lavage|A 18-gauge needle connected to a 5 ml syringe with 4 ml of saline solution will be used to puncture the calcification with freehand technique and under constant sonographic monitoring. With the tip of the needle placed in the center of the deposit, the calcification will be flushed. If backflow of calcific material can be identified in the syringe, lavage of the deposit will be performed by successive propulsion and aspiration with the syringe plunger. In cases where no material can be extracted, repeated perforation of the deposit will be performed to possibly initiate or accelerate spontaneous resorption.
16143486|NCT01831583|Device|Measurement of PPG waveforms|The ViSi Vital Signs Monitor will measure PPG waveforms for 4 hours.
16143487|NCT01831583|Device|Measurement of Pulse Arrival Time (PAT)|The ViSi Vital Signs Monitor will measure PAT waveforms for 4 hours.
16143613|NCT01830686|Other|Sugarcane bagasse|One brownie containing 10 g of sugarcane bagasse and 2 cookies containing 3 g of sugarcane bagasse (total of 13 g of sugarcane bagasse per day)
16143408|NCT01832363|Drug|HXe MRI guided treatment sequence for BT|HXe MRI consists in imaging the inhaled xenon gas inside the human lungs during a short breath-hold. High resolution 3D maps of the HXe distribution inside the lungs provide information regarding ventilation of the lungs, as the signal is proportional to the local concentration of HXe. A high MRI signal translates in unobstructed ventilation, while ventilation defects appear as dark regions on the map. HXe MRI will be performed pre and post bronchodilator in order to determine the airways which potentially are the most responsive to BT treatment. All HXe MRI images will be repeated within the same day for consistency check and after three weeks to study temporal variability. The reactivity of the airways will establish the treatment order, with the most problematic airways to be treated in the first BT session (not to exceed six).
16143409|NCT01832363|Other|Standard treatment sequence for BT (control)|Patients undergoing standard BT procedure will have HXe MRI performed at time intervals similar to HXe MRI guided BT patients. While HXe images will not be used for guiding the sequence for airways to receive the BT treatment, metrics extracted from HXe images will be compared with clinically accepted asthma severity metrics (spirometry and asthma questionnaires) to assess HXe MRI as a biomarker for asthma severity.
16143410|NCT01832350|Drug|Nuedexta (20/10)|Drug: Nuedexta (20/10) administered orally, two times a day, every 12 hours, during a 26-week period.
16143411|NCT01832337|Procedure|Limb remote ischemic preconditioning (LRIP)|Limb remote ischemic preconditioning (LRIP) consisted of three cycles of left upper limb ischemia induced by inflating a blood pressure cuff on the left upper arm to 200mmHg, with an intervening 5 minutes of reperfusion, during which time the cuff was deflated.
16143412|NCT01832311|Drug|Ketorolac|Patients (both non-diabetic and diabetic) were randomized into subgroups receiving topical nonsteroidal anti-inflammatory drug (NSAID) ketorolac 0.5%, dosed 4 times a day, starting 3-7 days before surgery and ending 4-5 weeks after surgery respectively, and into subgroups not receiving NSAID.
16143413|NCT01832298|Drug|Simmitecan Hydrochloride for Injection|Either at 12.5 mg, 25 mg、50 mg、80 mg、120 mg、160 mg、200 mg
16143414|NCT01832285|Drug|fluvoxamine|100mg/day, PO(in the mouth) each day during 6 weeks
16143415|NCT01832272|Procedure|Reinflation after early tourniquet deflation|The tourniquet is released after cement implant fixation, and then reinflated, once arterial bleeding was controlled
16143416|NCT01832259|Drug|Pazopanib|Pazopanib, 800 mg, orally daily for 28 days prior to radical prostatectomy.
16143417|NCT01832259|Other|Placebo|Placebo tablet orally, daily for 28 days prior to radical prostatectomy.
16143418|NCT01832233|Procedure|Renal Denervation|The Symplicity Renal Denervation System is indicated for the delivery of low-level radiofrequency energy through the wall of the renal artery to denervate the kidney and reduce blood pressure in adult patients with refractory hypertension. The Symplicity Generator delivers controlled relatively low power radiofrequency energy (approximately 8 watts for 2 minutes). The Symplicity System selectively denervates the kidney by delivering radiofrequency from the generator via the electrode of the catheter through the renal artery wall from the intra-luminal side to ablate the renal sympathetic efferent and afferent nerves and reduce overall sympathetic nervous system activity.
16143419|NCT01832207|Device|Transcutaneous electrical nerve stimulation|
16143420|NCT01832207|Device|Placebo transcutaneous electrical nerve stimulation|
16143421|NCT01832194|Drug|Botox|
16143422|NCT01832168|Procedure|Robotic Assisted Laparoscopic Prostatectomy|Robotic Assisted Laparoscopic Prostatectomy with nerve-sparing technique
16143423|NCT01832168|Other|Application of Absorbable Hemostat|Application of Surgicel® SNoW Absorbable Hemostat by Johnson and Johnson on the neurovascular bundle after removal of the cancerous prostate.
16143424|NCT01832168|Other|Application of dehydrated human amniotic membrane|Application of dehydrated human amniotic membrane (DHAM) on the neurovascular bundle after removal of the cancerous prostate.
16143425|NCT01832155|Behavioral|Hatha yoga|Hatha yoga poses that were specifically designed by a group of yoga experts for older adults with knee osteoarthritis. Program included physical poses and sequence that focus on strengthening the lower extremities, and relaxation techniques.
16143426|NCT01832155|Behavioral|Hatha Yoga|The same intervention was provided to the wait-list control group at the end of 8 weeks when the intervention completed their intervention classes.
16143427|NCT01832129|Drug|Oral administration of vitamin B12|Daily high dose oral vitamin B12 (1mg) will be administered over 4 weeks. The patients adherence to this regimen will be monitored with an electronic punch card.
16143428|NCT01832129|Drug|i.m. injection of vitamin B12|Intramuscular injections of 1 mg vitamin B12 will be performed at days 7, 14, and 21.
16143429|NCT01832116|Drug|89Zr-MMOT0530A|Injection of 89Zr-MMOT0530A followed by 2 or 3 PET scans at different time points
16143430|NCT01832103|Drug|MK-7145|
16143431|NCT01832090|Device|Radiesse® Injectable Dermal Filler|Calcium hydroxylapatite particles suspended in an aqueous based gel carrier.
16143432|NCT01832077|Device|90 D|rural doctors exam eye fundus by 90 D
16143433|NCT01832077|Device|fundus camera and grader|taking fundus pictures and graded by graders in ZOC
16143434|NCT01832064|Behavioral|Mailed Chronic Disease Self-Management Program|materials are mailed to participants
16143435|NCT01832051|Drug|89Zr-trastuzumab injection|
16143436|NCT01832038|Drug|Lacosamide|"Strength: Lacosamide (LCM) 50 mg, LCM 100 mg
~Formulation: Tablet
~Frequency: twice daily during the study period (until the date of approval)
~At the completion of EP0008 [NCT01710657], all subjects who choose to enroll in EP0009 will be taking a dose of Lacosamide 200 mg/day. At the beginning of EP0009, the investigator may maintain the LCM dose or increase or decrease the dose. During the Treatment Period, the investigator will be allowed to increase or decrease the dose of LCM to optimize tolerability and seizure reduction. The LCM dose may be decreased to 100 mg/day or increased, no faster than 100 mg/day per week, up to 400 mg/day."
16143437|NCT01832025|Procedure|internal maxillary sinus floor elevation technique|The internal lift procedure uses a drilling instrument (a drill that cuts through bone) to break through the bone for where the implant will later go. This creates an opening in the necessary area to allow more bone material to be added, which will move the sinus up and allow for the implant to be securely placed.
16143438|NCT01832025|Procedure|external maxillary sinus floor elevation technique|The external lift procedure involves cutting through the upper-most part of the gums to then cut through the bone to create an opening in the necessary area. The sinus will be manually lifted and the bone material will be added, which will allow for the implant to be securely placed.
16143441|NCT01831999|Behavioral|RecoveryTrack - Extended Care (RT-E)|Counselors in this condition will be trained on the RecoveryTrack-Extended Care (RT-E) web-based monitoring system so that they are able to navigate the computer application, and implement the clinical content and procedures of the intervention. Counselors will conduct monitoring and feedback sessions using RT-E for clients newly admitted to IOP over a course of eight months. If the client is not attending treatment, counselors will attempt contact over the phone and via other methods. When contacted, the counselor will conduct the RT-E assessment and, as the situation warrants, provide support to reengage the client in treatment or support recovery in other ways mentioned. HIV risk will be assessed as well, with encouragement of testing and referral to HIV specialists as needed.
16143442|NCT01831986|Dietary Supplement|Pregnenolone and L-Theanine|Pregnenolone (50 mg/day) with L-theanine (400 mg/day)
16143443|NCT01831986|Other|Placebo|Caps
16143444|NCT01831973|Drug|Lipotecan|
16143445|NCT01831960|Drug|cortexolone 17α-propionate|
16143446|NCT01831947|Biological|Ranibizumab|
16143447|NCT01831934|Biological|Fluzone®|This vaccine is given intramuscularly, either the 2010-2011 or 2011-2012 vaccination was given as appropriate
16143448|NCT01831921|Behavioral|Lifestyle Weight Loss|Changing diet, physical activity, and self-regulatory behaviors to promote weight loss.
16143449|NCT01831921|Behavioral|Counseling|Individual nutrition counseling will be delivered by a registered dietitian.
16143450|NCT01831908|Other|Lifestyle counseling|People attending the community center will be provided with information on their health problems and will receive advise on how to improve blood pressure, glucose and cholesterol levels.
16143451|NCT01831895|Device|MobiusHD™|Implant that is placed in the carotid sinus to control hypertension.
16143452|NCT01831869|Drug|L-thyroxine|
16143453|NCT01831856|Drug|1g of F373280|Oral administration, one capsule each evening with dinner.
16143454|NCT01831856|Drug|Placebo|Oral administration, one capsule each evening with dinner.
16143455|NCT01831843|Device|Group C|non-heated, non-humidified conventional breathing circuit was used in group C patient
16143456|NCT01831843|Device|Group E|breathing tube which apply humidity and heat (Evaqua™ Breathing Circuits manufactured by Fischer & Paykel)was used in group E patient
16143457|NCT01831843|Device|Group M|Heated humid tube with a warming device (Mega Acer kit manufactured by Acemedical,Seoul Korea)was used in group M patient
16143458|NCT01831830|Behavioral|The Veterans' In-home Program|VIP realigns environmental demands to match Veterans' abilities through the modification of home environments, development of meaningful activities tailored to Veterans' strengths, training in the use of emotion-regulation strategies to address behavioral/interpersonal difficulties, and training in the use of cognitive strategies to compensate for cognitive impairments. In its family focus, VIP provides family members with education and training to understand and manage the Veterans' limitations.
16143459|NCT01831817|Drug|5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice|Calcium sodium phosphosilicate dentifrice (5% w/w) and 1500 ppm F as sodium monofluorophosphate
16143460|NCT01831817|Drug|0% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice|No calcium sodium phosphosilicate and 1500 ppm F as sodium monofluorophosphate
16143461|NCT01831817|Drug|Sodium monofluorophosphate dentifrice|Sodium monofluorophospate dentifrice (1000 ppm F)
16143462|NCT01831817|Drug|Sodium Fluoride dentifrice|Dentifrice containing 1100ppm F as sodium fluoride
16143463|NCT01831804|Drug|GSK1278863|White to off-white smooth ointment with unit dose strength of 0.05%w/w, 0.1%w/w, 0.5%w/w, 1.0%w/w for topical application as single or repeat doses.
16143464|NCT01831804|Drug|Placebo|White to off-white smooth ointment for topical application as single or repeat doses.
16143465|NCT01831791|Drug|Dutasteride 0.5 mg|Dutasteride will be supplied as soft gelatin capsules, containing 0.5 mg of Dutasteride and it will be packaged in high-density polyethylene (HDPE) bottles with plastic child-resistant closures.
16143466|NCT01831765|Drug|Faster-acting insulin aspart|Injected subcutaneously (s.c., under the skin), dose individually adjusted. Meal time dosing is defined as injecting 0-2 minutes before the meal.
16143467|NCT01831765|Drug|insulin detemir|Injected subcutaneously (s.c., under the skin), dose individually adjusted. Administrated once or twice daily.
16143468|NCT01831765|Drug|insulin aspart|Injected subcutaneously (s.c., under the skin), dose individually adjusted.
16143469|NCT01831765|Drug|Faster-acting insulin aspart|Injected subcutaneously (s.c., under the skin), dose individually adjusted. Post meal time dosing is defined as injecting 20 minutes after the start of the meal.
16143470|NCT01831726|Drug|Dovitinib (TKI258)|Dovitinib (TKI) will be dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule.
16143471|NCT01831700|Drug|Lisinopril and Hydrochlorothiazide Tablets (20+25) mg|Lisinopril and Hydrochlorothiazide (20+25) mg Tablets once a day
16143472|NCT01831700|Drug|Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets|Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets once a day
16143473|NCT01831687|Drug|Etodolac Extended Release Tablets USP 600mg|Etodolac Extended Release Tablets USP 600mg once a day
16143474|NCT01831687|Drug|Etodolac Extended Release Tablets 600mg|Etodolac Extended Release Tablets 600mg once a day
16143475|NCT01831674|Drug|Metformin Hydrochloride Extended-Release Tablets USP 750|Metformin Hydrochloride Extended-Release Tablets 750 mg once a day
16143476|NCT01831674|Drug|GLUCOPHAGE®XR tablet 750 mg|GLUCOPHAGE®XR 750 mg once a day
16143477|NCT01831661|Drug|Metformin Hydrochloride Extended-Release Tablets USP 750 mg|Metformin Hydrochloride Extended-Release Tablets 750 mg once a day
16143478|NCT01831661|Drug|GLUCOPHAGE®XR|GLUCOPHAGE®XR 750 mg once a day
16143479|NCT01831648|Other|Blood sample|
16143480|NCT01831635|Other|Methodological pens|Randomisation of branded pen, non-branded pen and no pen
16143481|NCT01831635|Other|Methodological compensation|Randomisation of a £10 monetary reimbursement for expenses on completion of the study
16143482|NCT01831635|Other|Methodological trolley tokens|Trolley tokens to be randomly assigned to half of cases and General Practice controls.
16143483|NCT01831622|Drug|Ritalin|On one of the two test-dates the patient participant is administered methylphenidate, in the dose prescribed by the patients doctor.
16143484|NCT01831622|Drug|Placebo|On one of the test-dates the patient participants are administered a sugar pill, matching their prescribes medical dose.
16143488|NCT01831570|Other|GENETIC and radiographs|GENETIC : Blood sample for genetic analysis will be performed at inclusion in order to built a DNA collection OTHER: Serum samples will be performed at inclusion M0, M36 and M72 for serum biomarkers assessment OTHER : These radiographs will be performed at M0, M36 and M72
16143489|NCT01831557|Other|Blood samples will be taken for gene sequencing|
16143490|NCT01831544|Device|HeartWare MVAD® System|The HeartWare MVAD® System consists of a small, wearless, continuous flow pump and associated surgical tools and implant accessories, peripheral components which control and power the system, and a monitor which allows for programming and monitoring of the system
16143491|NCT01831531|Drug|S-1|S-1 40 mg (BSA ≤ 1.6 m2) or 50 mg (BSA >1.6 m2) p.o bid d1-28
16143492|NCT01831531|Radiation|Radiation therapy|A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks.
16143493|NCT01831518|Device|CRT Implant|
16143494|NCT01831518|Device|Body Surface ECG Mapping|
16143495|NCT01831505|Drug|Multiple drug microinjection: rituximab, vincristine, doxorubicin, bendamustine, prednisolone or a combination of them|
16143496|NCT01831492|Device|zeolite + dolomite|Given for 12 weeks, after a 4 weeks wash- out of all supplements/drugs
16143497|NCT01831492|Device|cellulose|given for 14 weeks
16143498|NCT01831479|Drug|Rosuvastatin|Single administration of rosuvastatin 20mg tablet QD for 7 consecutive days
16143499|NCT01831479|Drug|Olmesartan|Single administration of olmesartan 40mg tablet QD for 7 consecutive days
16143500|NCT01831479|Drug|Rosuvastatin and olmesartan|Co-administration of rosuvastatin 20mg tablet and and olmesartan 40mg tablet QD for 7 consecutive days
16143501|NCT01831466|Drug|tofacitinib ointment 20 mg/g|tofacitinib ointment 20 mg/g BID (twice daily) for 12 weeks
16143502|NCT01831466|Drug|tofacitinib ointment 10 mg/g|tofacitinib ointment 10 mg/g BID (twice daily) for 12 weeks
16143503|NCT01831466|Drug|placebo ointment (vehicle)|placebo ointment (vehicle) BID (twice daily) for 12 weeks
16143504|NCT01831466|Drug|tofacitinib ointment 20 mg/g|tofacitinib ointment 20 mg/g QD (once daily) for 12 weeks
16143505|NCT01831466|Drug|tofacitinib ointment 10 mg/g|tofacitinib ointment 10 mg/g QD (once daily) for 12 weeks
16143506|NCT01831466|Drug|placebo ointment (vehicle)|placebo ointment (vehicle) QD (once daily) for 12 weeks
16143507|NCT01831453|Drug|omega-3|polyunsaturated fatty acids(PUFAs) 1 gram three times per day for 6 months
16143508|NCT01831453|Drug|placebo|soft gelatinous capsules filled with isopropylmyristate oil
16143509|NCT01831440|Behavioral|medicine combined CBT|medicine：Clinical routine antidepressant treatment CBT：During the treatment period，weekly for 8 weeks，and monthly for the maintenance phase.Therapists receive group supervision monthly.
16143510|NCT01831440|Drug|medicine|Participants receive only clinical routine antidepressant treatment,Which include fluoxetine (Prozac); sertraline (Zoloft); paroxetine (Paxil); citalopram (Celexa) ;escitalopram (Lexapro) and fluvoxamine (Luvox). It will be chosen according to special condition of every patient.
16143511|NCT01831427|Drug|Andecaliximab|Andecaliximab administered by intravenous (IV) infusion or subcutaneous (SC) injection
16143512|NCT01831427|Drug|Placebo to match Andecaliximab|Placebo to match andecaliximab administered by IV infusion
16143513|NCT01831414|Other|Water immersion at cervical level|balneotherapy session of spinal cord patients with a Water immersion at cervical level
16143514|NCT01831414|Other|Water immersion at xyphoid level|balneotherapy session of spinal cord patients with a Water immersion at xyphoid level
16143515|NCT01831401|Procedure|Operating table position 0° head down (Horizontal)|
16143516|NCT01831401|Procedure|Operating table position 7° head down.|
16143517|NCT01831401|Procedure|Operating table position Y° head down|Operating table position Y° head down (angle required to obtain vertical Transverse Pelvis Lines).
16143518|NCT01831401|Device|Standard straight acetabular component introducer without alignment guide.|
16143519|NCT01831401|Device|Modified 35° acetabular component introducer.|
16143520|NCT01831401|Device|Inclinometer-assisted acetabular component introducer.|
16143521|NCT01831388|Other|breathing techniques|"During all practice sessions, patients are seated in a chair, where they are guided through a set routine of various breathing techniques (detailed in Appendix A). No yoga poses are involved. There is no demand on the patient's physical condition and no risk of injury. The breath training program, with patients seated throughout, includes:
~- an initial teaching session (approximately 30-minute) at main campus by an MSKCC Integrative Medicine Service yoga-breathing instructor; - twice daily,breathing exercises (each approximately 15-minute) for 6 weeks practiced by patients at home with supplied recorded audio instructions; - and weekly follow-up phone calls by research staff (+/- 3 days from day 7 of each week) to identify and manage problems and to determine compliance."
16143522|NCT01831388|Behavioral|Self-Administered Baseline and Transition Dyspnea Indexes|Patients are asked to complete baseline SAC-BDI/TDI questionnaires at the pulmonary clinic. Patients will return to the pulmonary clinic at about week 6 for SAC-BDI/TDI and tests, and to return the diary recording their home exercises. Resting and post-6MWT pulse oximetry, and Hospital Anxiety and Depression Scale (HADS) will be evaluated as well.
16143523|NCT01831375|Behavioral|Speak Up|Intervention group_treatment group
16143524|NCT01831375|Behavioral|Get connected|Participants will learn to be connected with social resources in the community.
16143525|NCT01831362|Behavioral|Mindfulness-Based Cognitive Therapy|
16143526|NCT01831362|Behavioral|Focused Attention (FA)|
16143527|NCT01831362|Behavioral|Open- Monitoring|
16143528|NCT01831323|Dietary Supplement|VSL#3|VSL#3
16143529|NCT01831323|Drug|Rifaximin|Rifaximin
16143530|NCT01831323|Drug|Mesalazine|Mesalazine
16143531|NCT01831323|Dietary Supplement|Psyllium|psyllium
16143532|NCT01831310|Dietary Supplement|Standard (Kabiven)|Parenteral nutrition provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line
16143533|NCT01831310|Dietary Supplement|Standard-Glutamine|Parenteral nutrition (Kabiven) provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. it was 0.3-0.4 g/kg/day for glutamine dipeptide (Dipeptiven) supplementation. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line
16143743|NCT01829568|Drug|Lenalidomide|Given PO
16143534|NCT01831310|Dietary Supplement|Standard-Omega 3 fatty acid|Parenteral nutrition (Kabiven) provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. The dose of omega 3 fatty acid (omegaven)supplementation was 0.1-0.2 g/kg /day. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line
16143535|NCT01831310|Dietary Supplement|Standard-glutamine-omega 3|Parenteral nutrition (kabiven) provided 25-30 kcal/kg/day energy and 0.15-0.20 g/kg/day nitrogen. The dose of omega 3 fatty acid (omegaven) supplementation was 0.1-0.2 g/kg /day and it was 0.3-0.4 g/kg/day for glutamine dipeptide (dipeptiven)supplementation. All nutrient substrates were mixed in 3 litre bags and infused in 24 h through a dedicated central venous line
16143536|NCT01831297|Device|measurement of blood pressure|measurement of pulse wave velocity
16143537|NCT01831284|Procedure|Sigmoidoscopy with biopsy|Sigmoidoscopy with biopsy
16143538|NCT01831271|Other|Prescribed physical activity|Prescribed physical activity is a tailored physical activity programme with monitoring of progress and a follow-up. Also includes interview: exploratory talk, commitment/decision, life style change, health promotion, evaluation of readiness for change, reflection, assessment of motivation, patient specific goal assessment, conclusion and plan for follow-up at 14 weeks. Patients are guided by the physiotherapist to increase their overall activity and strength with i.e. walking and other self-mediated activities and exercise.
16143539|NCT01831271|Other|Neck specific training|The active physiotherapy rehabilitation program consists of a standardised and structured physiotherapy program (twice a week) with medical exercise therapy and if needed vestibular rehabilitation. At the start of the intervention motivational interviewing will be included. Additionally once a week during the first 14 weeks of the program the physiotherapist informs the patient about physiology of pain, stress, exercise, breathing, relaxation, coping, pacing and ergonomics. All through the treatment program a cognitive approach from the physiotherapist according to theoretical behaviour change models will be used.
16143540|NCT01831258|Device|SensAwake On|
16143541|NCT01831258|Device|SensAwake Off|
16143542|NCT01831232|Drug|pravastatin sodium|Given PO
16143543|NCT01831232|Drug|idarubicin|Given IV
16143544|NCT01831232|Drug|cytarabine|Given IV
16143545|NCT01831232|Other|laboratory biomarker analysis|Correlative studies
16143546|NCT01831206|Procedure|Collagen cross-linking|"Collagen cross-linking arm will receive standard medication for corneal ulcer treatment and corneal collagen cross-linking.
~Standard treatment arm will receive only standard medication."
16143547|NCT01831193|Drug|Curcumin|
16143548|NCT01831167|Other|dynamic light|
16143549|NCT01831154|Drug|Tight Glycemic|The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline.
16143550|NCT01831154|Drug|Conventional Glycemic|The insulin infusion consisted of 100 units of regular insulin in 100 ml of normal saline.
16143551|NCT01831154|Drug|Standard Glycemic|Insulin was Regular Insulin administered intravenous bolus.
16143552|NCT01831128|Device|ASV Treatment|
16143553|NCT01831102|Other|none- observational study|
16143554|NCT01831089|Drug|PM01183 + paclitaxel +/- bevacizumab|"PM01183: 1 mg and 4 mg vials. Powder for concentrate for solution for infusion
~paclitaxel: 6 mg/ml concentrate for solution for infusion
~bevacizumab: 25 mg/ml concentrate for solution for infusion
~Once a recommended dose is defined for the PM01183 and weekly paclitaxel combination, the feasibility of adding bevacizumab to this combination will be explored in a prospectively selected cohort of patients"
16143555|NCT01831076|Drug|Exemestane|Given PO
16143556|NCT01831076|Drug|Exemestane and tamoxifen|exemestane 25 mg po daily and tamoxifen 20 mg po daily given concurrently for 4 months prior to surgery
16143557|NCT01831063|Behavioral|Simulation|The experimental group received a simulation based seizure teaching session in addition to the traditional seizure teaching
16143558|NCT01831050|Biological|Bivalent Oral Polio Vaccine (bOPV)|Produced by Sanofi Pasteur, Lyon, France, bivalent OPV vaccine contains types 1 and 3 polioviruses and it is indicated for supplementary immunization activities in children from 0 to 5 years of age to prevent or contain outbreaks caused by these 2 serotypes.
16143559|NCT01831050|Biological|Trivalent Oral Polio Vaccine (tOPV)|Produced by Sanofi Pasteur, Lyon, France, trivalent OPV vaccine contains types 1, 2, and 3 polioviruses and it is indicated for routine and supplementary prevention of poliomyelitis in children from 0 to 5 years of age.
16143560|NCT01831050|Biological|Monovalent Oral Polio Vaccine Type 2 (mOPV2)|Licensed monovalent OPV type 2 vaccine (mOPV2) by Glaxo SmithKline, Rixensart, Belgium. Polio Sabin Mono Two (oral) is a monovalent, live attenuated poliomyelitis virus vaccine of the Sabin strain Type 2 (P 712, Ch, 2ab), propagated in MRC5 human diploid cells.
16143561|NCT01831050|Biological|Sanofi-Pasteur IPV (Sanofi IPV)|Inactivated poliovirus vaccine is produced by Sanofi-Pasteur as a sterile suspension of 3 types of poliovirus. Each dose of vaccine (0.5 mL) contains 40 D antigen units of Mahoney strain (Type 1); 8 D antigen units of MEF-1 strain (Type 2); and 32 D antigen units of Saukett strain (Type 3).
16143562|NCT01831050|Biological|Glaxo SmithKline IPV (GSK IPV)|Inactivated poliovirus vaccine is produced by Glaxo SmithKline, Rixensart, Belgium, as a sterile suspension of 3 types of poliovirus. Each dose of vaccine (0.5 mL) contains 40 D antigen units of Mahoney strain (Type 1); 8 D antigen units of MEF-1 strain (Type 2); and 32 D antigen units of Saukett strain (Type 3).
16143563|NCT01831050|Biological|Serum Institute of India IPV (SII IPV)|Inactivated poliovirus vaccine produced by Nederland's Vaccin Instituut in Bilthoven, The Netherlands (acquired recently by Serum Institute of India [SII]) is licensed in the producing country and prequalified by the WHO. It consists of a sterile suspension of 3 types of poliovirus. Each dose of vaccine (0.5 mL) contains 40 D antigen units of Mahoney strain (Type 1); 8 D antigen units of MEF-1 strain (Type 2); and 32 D antigen units of Saukett strain (Type 3).
16143564|NCT01831037|Other|Regression of fibrosis|Regression of fibrosis will be defined by assessing yearly evolution of noninvasive markers in patients who received antiviral therapy before start of the study, and by comparing baseline markers before start of antiviral therapy to those on subsequent yearly visits in patients prospective recruited (>50% of cases).
16143565|NCT01831037|Other|Specific risk factors related to hepatocellular carcinoma|Such as: family history of liver cancer; body mass index; alcohol, smoking and recreational drug use status; dietary habits, including use of caffeinated drinks; comorbidities such as type 2 diabetes mellitus; use of medications for other chronic diseases such as statins and angiotensin-converting enzyme inhibitors.
16143566|NCT01831024|Device|Dignicap System|The DigniCap™ System consists of the digitized system for controlled scalp cooling (Digni C3) in conjunction with the soft, tight-fitting silicon cap (DigniCap™), the neoprene outer cap (DigniTherm™), and the liquid coolant (DigniCool). DIGNISTICK™ is prepared to log data from a treatment when inserted in the slot. DIGNICARD™ is a key card which has to be inserted in order to start a treatment.
16143567|NCT01831011|Drug|mildronate injection|
16143568|NCT01831011|Drug|cinepazide maleate injection|
16143569|NCT01831011|Drug|aspirin|
16143570|NCT01830985|Drug|VX-509|VX-509 dose may be increased every 8 weeks in a stepwise fashion from 100 to 150 mg and from 150 to 200 mg, as needed (determined by ongoing disease activity by CDAI)
16143571|NCT01830972|Drug|SA-ER 500 mg|oral tablets
16143572|NCT01830972|Drug|SA-IR 500 mg|oral capsules
16143573|NCT01830959|Drug|Roflumilast|Roflumilast
16143574|NCT01830959|Drug|Placebo|Placebo one a day
16143575|NCT01830946|Other|Whey Protein|Whey protein will be consumed every night of the week as the last food or caloric beverage prior to sleep in the evening at least two hours after dinner but no more than 30 minutes before bed.
16143576|NCT01830946|Other|Combined Resistance and High-Intensity Interval training|Completed 3 d/wk for 4 wks (2 d of Resistance Training (RT) and 1 d of High-Intensity Interval Training (HITT)). RT exercises were chest press, seated row,leg press, shoulder press, leg extension, and leg curl (3 total sets: 2 sets of 10 repetitions and a 3rd set to muscular exhaustion with a load equaling 75-85% of 1-Repetition Maximum(RM)). All exercises and sets were separated by 90-120 sec of rest. HIIT training was completed on commerical cardiovascular equipment and requires subjects to rate their perceived exertion on a scale from 1 to 10 (1= resting quietly, 5= a warm-up level, 10= an all-out exertion). Subjects warmed-up for 2 min at level 5 and increased their exertion each min for 3 min until level 9 is perceived and then recover at level 6 for 1 min. This pattern was repeated 4 times, where the 4th cycle subjects increased their last min of exertion to level 10, followed by 1-min recovery at the initial warm-up level 5.
16143577|NCT01830946|Other|Casein Protein|Casein protein will be consumed every night of the week as the last food or caloric beverage prior to sleep in the evening at least two hours after dinner but no more than 30 minutes before bed.
16143578|NCT01830933|Other|BreastCARE|Physician Report. At the time of an individual participant's visit to her primary care physician and her completion of the assessment tool, her physician will receive a physician report. The physician report is designed to facilitate communication about breast cancer risk during the primary care visit and to provide tailored risk reduction recommendations.
16143579|NCT01830920|Drug|THR-184|THR-184 is a synthetic oligopeptide administered intravenously.
16143580|NCT01830920|Drug|Placebo|A normal saline solution identical in appearance to the active drug solution
16143581|NCT01830907|Dietary Supplement|carbohydrates|
16143582|NCT01830907|Dietary Supplement|vitamins|
16143583|NCT01830894|Device|MRI|3 MRI on different times during the study for each arm.
16143584|NCT01830881|Drug|Midazolam|5 mL oral midazolam oral syrup (2 mg/mL) 30-60 minutes prior to procedure
16143585|NCT01830881|Drug|Ibuprofen|800 mg oral ibuprofen 30-60 minutes prior to procedure
16143586|NCT01830881|Other|Placebo-Cherry syrup|5 mL oral placebo-cherry syrup 30-60 minutes prior to procedure
16143587|NCT01830881|Drug|Lidocaine|injection of 20 mL 1% lidocaine without epinephrine
16143588|NCT01830868|Drug|Zonisamide tablets|The recommended initial daily dose is 50 mg in two divided doses. After one week the dose may be increased to 100 mg daily and thereafter the dose may be increased at weekly intervals, in increments of up to 100 mg. Doses of 300 mg to 500 mg per day have been shown to be effective, though some patients, especially those not taking CYP3A4 (cytochrome P450)-inducing agents, may respond to lower doses.
16143589|NCT01830855|Biological|rLP2086|0.5 mL dose, given at 0, 2 and 6 months (lot 1)
16143590|NCT01830855|Biological|rLP2086|0.5 mL dose, given at 0, 2 and 6 months (lot 2)
16143591|NCT01830855|Biological|rLP2086|0.5 mL dose, given at 0, 2 and 6 months (lot 3)
16143592|NCT01830855|Biological|Havrix (HAV)|0.5 mL dose or 1.0 mL dose dependent on age given at month 0 and 6.
16143593|NCT01830855|Biological|Saline|0.5 mL dose of sterile normal saline for injection.
16143594|NCT01830842|Drug|Nicotine polacrilex|nonsmokers will be measured following nicotine administration
16143595|NCT01830842|Drug|Placebo|nonsmokers will be measured following placebo administration
16143596|NCT01830842|Other|satiety|smokers will be measured in a smoking satiated condition
16143597|NCT01830842|Other|abstinence|smokers will be measured following 24-hours of smoking abstinence
16143598|NCT01830829|Drug|Jalyn|study drug
16143599|NCT01830829|Drug|Placebo|Placebo
16143600|NCT01830816|Drug|Ixazomib|Ixazomib capsules
16143601|NCT01830790|Drug|Sildenafil citrate|Single dose of 100mg Sildenafil citrate
16143602|NCT01830777|Drug|Brentuximab Vedotin|Intravenously on Day 1 during re-induction therapy. Intravenously every 21 days during maintenance therapy
16143603|NCT01830777|Drug|Mitoxantrone|Intravenously on Days 3-7 of re-induction therapy.
16143604|NCT01830777|Drug|Etoposide|Intravenously on Days 3-7 of re-induction therapy.
16143605|NCT01830777|Drug|Cytarabine|Intravenously on Days 3-7 of re-induction therapy.
16143606|NCT01830764|Drug|Red Light (PDT)|LTS, 0.3% applied topically followed by red light dose (75 J/cm2 or 150 J/cm2)
16143607|NCT01830751|Other|Restrained Sitting Treatment|Training in avoidance of trunk flexion, with the use of a tall backrest with lumbar support to which the participant straps themselves. Participants are taught to strap into the backrest while while seated in a chair, and with hips and knees bent at right angles, for one hour at the appointed time of day.
16143608|NCT01830738|Procedure|Single-port, peri-umbilical hysterectomy|Patients in this arm have a hysterectomy via a single-port peri-umbilical laparoscopic surgical technique.
16143609|NCT01830738|Procedure|Multi-port hysterectomy|Patients in this arm have a hysterectomy via a conventional multi-port laparoscopic surgical technique.
16143610|NCT01830712|Drug|eptacog alfa (activated)|A review of retrospectively longitudinal data gathered in the routine follow-up from a subset of patients who underwent EOS in studies F7HAEM/USA/3/USA and F7HAEM/USA/4/USA (NCT01561391). Data will be compiled, analysed, and reported in aggregate form.
16143611|NCT01830699|Drug|Rilonacept|160 mg intra-bursal once
16143614|NCT01830686|Other|Non-caloric, non-fermentable fiber|One brownie containing 10 g of fiber and 2 cookies containing 3 g of fiber (total of 13 g of non-caloric, non-fermentable fiber per day)
16143615|NCT01830686|Other|Minimal fiber|One brownie containing 3g of fiber and two cookies containing 1g of fiber (total of 4 g of dietary fiber per day)
16143616|NCT01830660|Drug|Hetrombopag Olamine Tablets|
16143617|NCT01830660|Drug|placebo|
16143618|NCT01830634|Behavioral|Theraband with strengthening and stretching exercise|"Using the theraband for strengthening and stretching the upper and lower extremity muscles.
~All exercises were performed by using a Theraband in the following movements: shoulder elevating and abducting, horizontal and oblique direction, plantar flexion, dorsi-flexion, inversion and eversion of ankle, knee extension and hip abduction. The stretching exercises were focused on the hamstring muscle and heel cord. Each movement was held for 5 seconds. The participants were instructed to perform 5-10 repetitions of each movements twice per day."
16143619|NCT01830621|Drug|BBI608|
16143620|NCT01830621|Drug|Placebo|
16143621|NCT01830621|Other|Best Supportive Care|
16143622|NCT01830595|Drug|Recombinant Lactoferrin|
16143623|NCT01830595|Drug|Placebo|
16143624|NCT01830582|Procedure|Advanced MR Imaging|
16143625|NCT01830569|Behavioral|The EBMeDS system|"The EBMeDS system receives structured patient data from the electronic medical records in HealthOne and returns reminders, therapeutic suggestions and diagnosis-specific links to guidelines. Electronic forms and calculators (e.g. a calculator for glomerular filtration) are integrated in the system.
~The original EBMeDS system was developed by Duodecim in Finland and covers a full spectrum of all clinical areas. Relevant reminders in all clinical areas are shown to the physicians in the intervention group."
16143626|NCT01830569|Other|Evidence Linker|The Evidence Linker is already integrated in Belgian routine practice since 2012 and could be considered as part of the usual care process. When entering a diagnosis coded in ICPC, relevant clinical practice guidelines are retrieved by the Evidence Linker and could by consulted on the initiative of the family physician.
16143627|NCT01830556|Drug|Cetuximab|Group A:Day 1 Cetuximab 400 mg/m2 iv 120 minutes Day 8 and 15 Cetuximab 250 mg/m2 iv 60 minutes Day 1 Cisplatin 100mg/m2 or Carboplatin AUC 5 day 1-4 5-Fluorouracil 1000 mg/m2 iv 24 h Group B day 1 Cetuximab 400 mg/m2 iv 120 minutes Day 8 and 15 Cetuximab 250 mg/m2 iv 60 minutes day 1 Paclitaxel 175 mg/m2 day 1 Carboplatin AUC 5 treatment for 6 cycles thereafter day 1 Cetuximab 500 mg/m2 every second week treatment until progress or unacceptable toxicity
16143628|NCT01830543|Drug|rivaroxaban 2.5 mg|One 2.5 mg tablet twice daily for up to twelve months
16143629|NCT01830543|Drug|rivaroxaban 15 mg|One 15 mg tablet once daily for up to twelve months
16143630|NCT01830543|Drug|rivaroxaban 10 mg|One 10 mg tablet once daily for up to twelve months
16143631|NCT01830543|Drug|aspirin (ASA)|Low-dose aspirin tablet once daily for twelve months
16143632|NCT01830543|Drug|vitamin K antagonist (VKA)|Dose-adjusted VKA tablet (target International Normalized Ratio (INR) 2.0 to 3.0) once daily for twelve months
16143633|NCT01830543|Drug|clopidogrel|One 75 mg tablet once daily for up to twelve months
16143634|NCT01830543|Drug|prasugrel|One 10 mg tablet once daily for up to twelve months
16143635|NCT01830543|Drug|ticagrelor|One 90 mg tablet twice daily for up to twelve months
16143636|NCT01830530|Drug|Telmisartan|Subjects treated with telmisartan 80 mg (1 capsule daily in the morning) plus nifedipine slow release 30 mg (1 capsule daily in the morning) combination
16143637|NCT01830530|Drug|Nifedipine|Subjects treated with telmisartan 80 mg (1 capsule daily in the morning) plus nifedipine slow release 30 mg (1 capsule daily in the morning) combination
16143638|NCT01830530|Drug|placebo|two tablets daily in the morning
16143639|NCT01830517|Drug|Amlodipine, Losartan|
16143640|NCT01830504|Drug|BKM120|"BKM 120, 100 mg/day continuously. For patients who do not tolerate the protocol-specified dosing schedule, dose adjustments are permitted in order to allow the patient to continue the study treatment. Dose level -1 : 80 mg/day continuously, Dose level -2 : 80 mg/day 5 days out of 7. All dose modifications, interruptions or discontinuations must be based on the worst preceding toxicity as graded by the NCI Clinical Toxicity Criteria (NCI-CTCAE version 4.03.
~A change from continuous schedule to intermittent (5 days out of 7) must be preceded by 2 days without treatment."
16143641|NCT01830491|Drug|Clopidogrel|
16143642|NCT01830491|Drug|aspirin 100mg|
16143643|NCT01830478|Drug|Lenalidomide|Lenalidomide 20 mg p.o. once daily, days 1-21 every 28 days, for 6 cycles
16143644|NCT01830478|Drug|Rituximab|Rituximab 375 mg/m2 intravenously, day 14 of every course for 6 cycles
16143645|NCT01830465|Drug|Bortezomib (VELCADE)|1,3 mg/m2, intravenous bolus (over 3-5 seconds) on days 1, 4, 8, 11 of each 21 day cycle. Number of Cycles: 6.
16143646|NCT01830465|Drug|Rituximab|375 mg/m2 as intravenous infusion on day 1 of cycle III, IV, V, VI. Two additional doses will be administered at week + 3 and week + 6 after cycle VI.
16143647|NCT01830452|Procedure|Self-fixating Parietex Progrip Mesh|Lichtenstein hernioplasty using a self fixating Parietex Progrip mesh not needing any fixating devices
16143648|NCT01830439|Drug|PA-824 200mg|Two single administrations of 200mg PA-824 each administered by four 50mg tablets, one administered in the fed state and one administered in the fasted state. The two administrations were separated by 8 days.
16143649|NCT01830439|Drug|PA-824 50mg|Two single administrations of 50mg PA-824 each administered by one 50mg tablet, one administered in the fed state and one administered in the fasted state. The two administrations were separated by 8 days.
16143650|NCT01830400|Drug|Eslicarbazepine Acetate tablets|The Eslicarbazepine Acetate (ESL) Summary of Product Characteristics (SPC) recommended a starting dose of 400 mg once-daily (QD) which was increased to 800 mg QD after one or two weeks. Based on individual response, the dose was increased to 1200 mg QD. Treatment decisions were made by clinicians in agreement with the participant, and were independent of participation in the study.
16143651|NCT01830387|Device|Polymetric clips|The study team will prospectively enroll subjects with a diagnosis of appendicitis who are scheduled for laparoscopic appendectomy to have Hem-o-Lok® clips used for closure of the appendiceal stump.
16143652|NCT01830387|Other|Endoscopic Staplers|The study team will retrospectively identify patients who have undergone laparoscopic appendectomy by performing a database search. The operative notes will be reviewed for these patients to select patients who underwent ligation of the appendix with an endoscopic stapler.
16143653|NCT01830361|Drug|midostaurin (PKC412)|Midostaurin 50 mg (2 capsules) twice daily days 8-21 in induction II + consolidation I-III; maintenance treatment twice daily continuously for 12 months
16143654|NCT01830348|Drug|DSC127|DSC127 0.03%, daily topical application to diabetic foot ulcer for a period of up to 28 days or until ulcer closure, whichever is sooner
16143655|NCT01830348|Drug|placebo vehicle gel|
16143656|NCT01830335|Drug|Indomethacin|
16143657|NCT01830335|Drug|Placebo|
16143658|NCT01830322|Drug|CPI-613|CPI-613 drug product, provided in concentrated form at 50 mg/mL, must be diluted with D5W prior to administration. CPI-613 is to be infused intravenously (IV) via a central venous catheter. CPI-613 will be given 2x weekly, administered on Days 1 and 4 of each of the 3 treatment weeks, followed by a week of rest. The dose of CPI-613 will be 3,000 mg/m2 infused IV over 2 hours (this is approximate maximum tolerated dosing [MTD]), via a central venous catheter with D5W running at a rate of about 125-150 mL/hr.
16143659|NCT01830322|Drug|Gemcitabine|
16143660|NCT01830322|Drug|Any non-gemcitabine chemotherapies or best supportive care|
16143661|NCT01830309|Drug|CJ-12420 200mg|"Period1: CJ-12420 200mg fed condition Period2: CJ-12420 200mg fasting condition
~Period1: CJ-12420 200mg fasting condition Period2: CJ-12420 200mg fed condition"
16143662|NCT01830296|Drug|Remifentanil+morphine|Morphine, Remifentanil+Morphine
16143663|NCT01830283|Biological|varicella vaccine|The providers would get varicella vaccine
16143664|NCT01830270|Drug|Epirubicin|8 weekly cycles of chemotherapy with epirubicin (50 mg/m2)associated with cisplatin and paclitaxel with a break of one week without chemotherapy between cycle 4 and 5.
16143665|NCT01830270|Drug|Cisplatin|8 weekly cycles of chemotherapy with cisplatin (30 mg/m2) associated with epirubicin and paclitaxel with a break of one week without chemotherapy between cycle 4 and 5.
16143666|NCT01830270|Drug|Paclitaxel|8 weekly cycles of chemotherapy with paclitaxel (90 mg/m2) associated with epirubicin and paclitaxel with a break of one week without chemotherapy between cycle 4 and 5.
16143667|NCT01830270|Procedure|gastric surgery|surgery will be scheduled within 4-6 weeks after the end of the last cycle of chemotherapy.
16143668|NCT01830257|Other|sending message|Sending the suggestive short message
16143669|NCT01830244|Drug|Nab-Paclitaxel|Nab-Paclitaxel- 125 mg/m2 days 1,8, 15 for 12 weeks
16143670|NCT01830231|Drug|Cabazitaxel|Cabazitaxel, to be given intravenously once every 21 days, starting at a dose of 25 mg/m2 as a 1-hour intravenous infusion.
16143671|NCT01830231|Drug|Vinflunine|"Vinflunine, to be given intravenously once every 21 days, as a 20 minute intravenous infusion, starting at a dose of:
~320 mg/m2 in patients aged ≤75 years with PS 0 and no prior pelvic radiation, and of
~280 mg/m2 in patients aged >75 - ≤80 years or with PS 1 or prior pelvic radiation,
~250 mg/m2 in patients aged >80 years."
16143672|NCT01830218|Procedure|Obstetric anesthesia and analgesia|All anesthesia procedures during labor: labor analgesia, anesthesia for Cesarean section, anesthesia for procedures in third stage of labor
16143673|NCT01830205|Drug|Daclatasvir|
16143674|NCT01830192|Other|Training set|We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative
16143675|NCT01830192|Other|VERIFICATION SET|We evaluate the clinical, ultrasound and laboratory features to predict endometrial cancer disease preoperative
16143676|NCT01830166|Radiation|Low Dose Radiation Focal Brachytherapy|Low Dose Radiation Focal Brachytherapy
16143677|NCT01830153|Drug|RAD001|
16143678|NCT01830140|Drug|Bimatoprost 0.01%|Bimatoprost 0.01% (LUMIGAN® 0.01%) administered each evening in both eyes for 6 weeks.
16143679|NCT01830140|Drug|Bimatoprost 0.03%|Bimatoprost 0.03% (LUMIGAN® 0.03%) administered each evening in both eyes for 6 weeks.
16143680|NCT01830127|Drug|Ribavirin|24 Weeks
16143681|NCT01830127|Drug|BI 207127 high dose|24 Weeks
16143682|NCT01830127|Drug|Faldaprevir|24 Weeks
16143683|NCT01830127|Drug|Ribavirin|24 Weeks
16143684|NCT01830127|Drug|BI 207127 low dose|24 Weeks
16143685|NCT01830127|Drug|Faldaprevir|24 Weeks
16143686|NCT01830114|Behavioral|Web app|The Checkup and Choices web application
16143687|NCT01830101|Drug|TMZ plus concurrent re-irradiation|
16143688|NCT01830101|Drug|Temozolomide|low-dose temozolomide daily for one year
16143689|NCT01830088|Behavioral|Attachment Based Family Therapy|Attachment-Based Family Therapy (ABFT) is is primarily a process oriented, emotion focused treatment guided by a semi-structured treatment protocol. ABFT aims to improve the family's capacity for problem solving, affect regulation, and organization. This strengthens family cohesion which can buffer against depression, suicidal thinking, and risk behaviors
16143690|NCT01830088|Behavioral|Enhanced Usual Care|No attempt is made to control any aspect of the enhanced usual care except for pre-scheduled assessment plan
16143691|NCT01830075|Behavioral|Consultations|The patients receive two consultations with a spiritual counsellor. In these consultations life evens and life goals are discussed.
16143692|NCT01830062|Other|NIRS|Near infrared spectroscopy of at least 2 major epicardial vessels
16143693|NCT01830062|Other|CACS|Coronary artery calcium score assessed by multi-slice computed tomography
16143694|NCT01830049|Other|Take blood|
16143695|NCT01830023|Device|cardiac ultrasound examination|cardiac ultrasound examination to examine the vitality
16143696|NCT01830010|Drug|Study Part 1: KRP203|All subjects will receive KRP203 for 111 days
16143697|NCT01830010|Drug|Study Part 2: KRP203 lower dose|
16143698|NCT01830010|Drug|Study Part 2: KRP203 higher dose|
16143699|NCT01829997|Device|nanOss Bioactive 3D BVF|nanOss Bioactive 3D BVF, combined with autograft and bone marrow aspirate, used in the posterolateral spine between L2 and S1. Instrumentation is required. Interbody fusion with PEEK device and autograft may or may not be performed.
16143700|NCT01829984|Other|Verbal and Written Instruction|"Pre-teaching Evaluation: Patient
~Pre-teaching Evaluation: Caregiver
~o To be completed immediately before the teaching. Administered by the nurse who will provide the teaching. The form utilized will depend on if the patient or caregiver will be administering the injection.
~Post-teaching Evaluation: Patient Post-teaching Evaluation: Caregiver To be completed immediately after the teaching. Administered by the nurse who provided the teaching. The form utilized will depend on if the patient or caregiver will be administering the injection."
16143744|NCT01829568|Other|Pharmacological Study|Correlative studies
16143745|NCT01829568|Biological|Rituximab|Given IV
16143701|NCT01829984|Other|Verbal and Written Plus Simulation|"Post-injection Evaluation: Patient
~Post-injection Evaluation: Caregiver
~o To be completed after the injection is administered (outside of MSKCC) by the patient or caregiver. The form utilized will depend on if the patient or caregiver has administered the injection. They will return this evaluation at the patient's next visit (2 weeks later).
~Nurse Evaluation: Control
~Nurse Evaluation: Model o To be completed immediately following the completion of the teaching by the nurse. The form utilized will depend on if the teaching was part of the control or intervention phase of the study."
16143702|NCT01829971|Drug|MRX34|micro RNA therapy
16143703|NCT01829958|Drug|rituximab|
16143704|NCT01829958|Drug|prednisone|
16143705|NCT01829958|Behavioral|Geriatric Assessment|
16143706|NCT01829932|Dietary Supplement|Factor Altered Diet|
16143707|NCT01829919|Drug|Brisdelle (paroxetine mesylate)|All subjects will receive Brisdelle (paroxetine mesylate) Capsules 7.5 mg, first as a single dose and then, following a five-day wash-out period, once per day for 14 days.
16143708|NCT01829906|Behavioral|Multidisciplinary outpatient programme|
16143709|NCT01829906|Behavioral|Inpatient lifestyle programme|
16143710|NCT01829893|Drug|In combination of 0.2mg finasteride and 5mg tamsulosin|oral medication with 240 mL water
16143711|NCT01829893|Drug|GL2701 capsule|oral medication with 240 mL water
16143712|NCT01829867|Drug|sNN0031|
16143713|NCT01829841|Drug|Famitinib|Famitinib 25 mg p.o. qd
16143714|NCT01829841|Drug|Sunitinib|Sunitinib 50 mg p.o. qd
16143715|NCT01829828|Behavioral|No intervention|This is an observational study with no investigational drug administered.
16143716|NCT01829815|Behavioral|Parents Make the Difference|"The intervention, entitled Parents Make the Difference, will include 10 sessions. Parents will attend in a group, and sessions will include didactic information, guided discussion, and modeling and practice of new skills. All sessions focus on positive parenting skills, with specific skills across three domains that have strong links to child outcomes: (a) positive, non-physical behavior management strategies, (b) strategies for promoting children's early learning, and (c) strategies, primarily use of bed nets, for preventing malaria in children."
16143717|NCT01829802|Drug|Ritonavir boosted Atazanavir|Ritonavir boosted Atazanavir 300/100 mg QD in combination with other drugs
16143718|NCT01829802|Drug|Raltegravir|Raltegravir 400 BID in combination with Ritonavir boosted Atazanavir 300/100 mg QD during 48 weeks
16143719|NCT01829802|Drug|TDF/FTC (or 3TC)|Fixed dose combination of Tenofovir 300 mg/Emtricitabine 200 mg or Tenofovir 300 mg/Lamivudine 300 mg plus Ritonavir Boosted Atazanavir 300/100mg given once a day
16143720|NCT01829789|Behavioral|Group Community Reinforcement Training for Parents|
16143721|NCT01829789|Behavioral|Individual Community Reinforcement Training for Parents|
16143722|NCT01829776|Behavioral|Educational intervention|This is an 8-week comprehensive fall prevention exercise and education program, with one 2-hour session each week, for people with MS, adapted from a similar program for older adults.
16143723|NCT01829763|Drug|injection botox|
16143724|NCT01829750|Genetic|Cardiac progenitor cell infusion|"(Stage 1) Cardiac progenitor cell infusion in patients who assigned as active comparator group
~(Stage 2) Rescuing transplantation is applicable in patients, along with their written consent, 4 months after palliations who were allocated as control group in stage 1."
16143725|NCT01829711|Drug|Moxetumomab pasudotox|
16143726|NCT01829711|Drug|IV Bag Protectant for Moxetumomab pasudotox|
16143727|NCT01829698|Drug|tauroursodeoxycholic|Testing arm: tauroursodeoxycholic acid, 750mg , divided into three times, each time 250mg, oral administration, after meal
16143728|NCT01829698|Drug|ursodeoxycholic acid|ursodeoxycholic acid, 750mg ,divided into three times, each time 250mg, oral administration, after meal
16143729|NCT01829685|Drug|Entecavir, Adefovir|
16143730|NCT01829672|Radiation|Dual-energy computed tomography investigation|"1x 20ml Ultravist (370mg J/ml)3-5ml/s, i.v.
~1x 40ml Ultravist (370mg J/ml)3-5ml/s i.v. Contrast agent administration"
16143731|NCT01829659|Drug|Ticagrelor|
16143732|NCT01829646|Other|functional MRI|Functional MRI on day 22 of the chemoradiotherapy treatment. Parameters of these images will be later on correlated with outcome.
16143733|NCT01829646|Other|Hypoxia gene expression profile.|Tumour biopsies will be obtained as part of the staging procedure (standard). On this biopsies we will conduct a hypoxia gene expression profile (15 genes on PCR that can be analyzed individually or as a group through one binary variable). Hypoxia will be a parameter in our prognostic/predictive model.
16143734|NCT01829646|Other|Functional MRI before start of treatment.|As part of the standard staging procedure all patients will undergo an MRI of the neck. We will however also take DWI and DCE images at this time point. Parameters of these images will be later on correlated with outcome.
16143735|NCT01829633|Procedure|Physiotherapy|Shoulder physiotherapy with exercises
16143736|NCT01829620|Behavioral|TAU|This is standard outpatient mental health care that is routinely provided in study site outpatient clinics.
16143737|NCT01829620|Behavioral|CCVT+TAU|"Participants in the CCVT + TAU condition will receive caring texts at 1 day, 1 week, 1, 2, 3, 4, 6, 8, 10, & 12 months, and on their birthday. Text messages will indicate a general concern for the individual and a link to a website with general resources including behavioral health and crisis services.
~Participants in both conditions will continue to receive usual behavioral health care according to standard operating procedures."
16143738|NCT01829607|Other|Functional electrical stimulation of peripheral muscles|
16143739|NCT01829594|Other|Case management|Nurses and a physiotherapist (PT) worked as case managers (CM). The intervention lasted 12 months and comprised 4 dimensions. The first was traditional CM tasks: assessment, planning, monitoring, care coordination and evaluation. Home visits were made at least once a month. The second and third was general and specific information related to the participants' situation. The fourth part included aspects of continuity and safety. The PT also paid home visits and made an assessment regarding physical function and balance. The intervention consisted of multidimensional prevention of falls and/or consequences of falls, and supporting and motivating the participant to increased physical activity. When those in the control group had participated for 12 months they were offered the intervention.
16143740|NCT01829581|Other|no intervention, only descriptive data analysis|
16143741|NCT01829568|Drug|Ibrutinib|Given PO
16143742|NCT01829568|Other|Laboratory Biomarker Analysis|Correlative studies
16143746|NCT01829555|Behavioral|contingency management|Participants will receive a voucher for each self-monitored blood glucose test completed during the target testing window, and a bonus amount for each day that 4 tests fall within the testing windows and are separated by more than 2 hours.
16143747|NCT01829542|Dietary Supplement|Freeze-dried blueberry powder dissolved in water|Wild blueberry freeze-dried powder dissolved in water
16143748|NCT01829542|Dietary Supplement|Control|Macro- and micro-nutrient matched control in water
16143749|NCT01829529|Drug|Amoxicillin|Amoxicillin
16143750|NCT01829516|Drug|Oxytocin|Intranasal oxytocin
16143751|NCT01829516|Drug|Placebo|Intranasal placebo
16143752|NCT01829503|Drug|decitabine and cytarabine|
16143753|NCT01829503|Other|Supportive Care|blood product transfusions, antiemetic medications, antiviral and antifungal medications, empiric antibiotics
16143754|NCT01829490|Biological|ChAdOx1 85A|Intramuscular injection
16143755|NCT01829490|Biological|MVA85A|Intramuscular injection
16143756|NCT01829477|Drug|TAK-875|TAK-875 50 mg tablets
16143757|NCT01829477|Drug|TAK-875 Placebo|TAK-875 placebo-matching tablets
16143758|NCT01829477|Drug|Glimepiride|Glimepiride tablet.
16143759|NCT01829464|Drug|Placebo|TAK-875 placebo-matching tablets
16143760|NCT01829464|Drug|TAK-875|TAK-875 tablets
16143761|NCT01829464|Drug|TAK-875|TAK-875 tablets
16143762|NCT01829451|Other|Hyaluronic acid gel|"Hyaluronic acid gel is placed into the uterus after endometrial ablation
~--------------------------------------------------------------------------------"
16143763|NCT01829438|Behavioral|Listening to fast music|
16143764|NCT01829438|Behavioral|Listening to preferred music|
16143765|NCT01829438|Behavioral|Listening to slow music|
16143766|NCT01829425|Drug|Anticholinergic medications|The study will use either of two standard, long acting anti-cholinergic medications and dosages. Pharmacotherapy counseling sessions will also be administered over 8 weeks by trained research personnel. Pharmacotherapy counseling sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the medication counselor administers the sessions in a standardized fashion. Pill counts will be performed at the conclusion of the 8 weeks of pharmacotherapy counseling. Subjects will be provided the medication for 1 year.
16143767|NCT01829425|Behavioral|Hypnotherapy|Hypnotherapy will be administered approximately weekly over 8 weeks by certified, trained clinical hypnotherapists. Sessions will be audio-recorded and one or more sessions will be reviewed by study personnel to ensure that the hypnotherapist administers the hypnotherapy session in a standardized fashion.Subjects will receive or download a digital recording specially prepared for them to for home practice of hypnotherapy sessions.Following the 8 weeks of therapy, subjects will be encouraged to continue to practice self-hypnosis and/or listen to their home practice digital recording and this practice will be tracked for the 1 year duration of the study.
16143768|NCT01829412|Other|DW-MRI|MRI imaging with diffusion weighted sequences of the whole body
16143769|NCT01829399|Drug|Bupivacaine with Epinephrine|10-15 mL 0.25% Bupivicaine with epinephrine 1:200,000 subcutaneous axillary ring
16143770|NCT01829399|Drug|Normal Saline|
16143771|NCT01829386|Other|MRI scans with non heme iron levels|"MRI scans of the head will be performed to determine the amount of Non heme iron in areas of the brain of hemorrhagic stroke patients and hopefully predict the amount of brain damage.
~Each MRI will take up to 1 hour to complete and will be done on day 3, day 14 and day 30. Some of the (MRIs) Magnetic Resonance Imaging will be clinically indicated and sequences will be added to the clinical scan with each sequence adding 10 minutes to the scan. Some sequences will be done only for research."
16143772|NCT01829373|Biological|vaccine 1650-G|
16143773|NCT01829360|Behavioral|Treatment (interactive book reading, dialogic reading, shared book reading)|Children receive 2 rounds of treatment with interactive book reading. Each treatment teaches 30 words that the children do not know. Treatments vary in dose (the number of times the words is heard/taught in an individual book reading session: 4 vs. 6 vs. 9) and dose frequency (the number of times book reading sessions are repeated: 4 vs. 6. vs. 9). Across all dose x dose frequency combinations, children hear/are taught the 30 words 36 times, which has been shown to be the adequate overall intensity of the intervention.
16143774|NCT01829347|Biological|ELAD|ELAD is an extracorporeal system that draws blood from the subject via a dual-lumen catheter placed in a large vein, and then separates the plasma fluid (ultrafiltrate) from cellular components using a specifically-designed ultrafiltrate generator cartridge. While the cellular components are returned to the subject via the venous access, the ultrafiltrate is circulated at a high flow rate through the four metabolically-active ELAD cartridges which contain cloned, immortalized human hepatoblastoma cells (VTL C3A cells) derived from a subclone of the human hepatoblastoma cell line HepG2.
16143775|NCT01829347|Other|Standard of Care treatment|Standard of care treatment is predefined treatment for sAAH complications (ascites, hepatic encephalopathy, varices, etc.) per AASLD/EASL Guidelines.
16143776|NCT01829334|Other|ART dental sealant|ART dental sealant placed with glass ionomer material using the ART technique on permanent first molar, single-time placement and no replacement
16143777|NCT01829334|Other|Resin dental sealant|Resin dental sealant placed on pits and fissures of first permanent molars, single-time placement and no replacement
16143778|NCT01829334|Other|Sodium fluoride varnish|Topical application of 5% sodium fluoride varnish onto pits and fissures of permanent first molars, repeated every 6 months
16143779|NCT01829334|Other|Silver fluoride solution|Topical application of 38% silver fluoride solution onto pits and fissures of permanent first molars, repeated every 12 months
16143780|NCT01829321|Drug|GLPG0974|1 capsule in the morning and 1 capsule in the evening with food during 28 days
16143781|NCT01829321|Drug|Placebo|1 capsule in the morning and 1 capsule in the evening with food during 28 days
16143782|NCT01829308|Behavioral|The brief interventions are delivered by behavioral health counselors (Specialist)|Behavioral Health Specialists perform the brief intervention. The screening and referral to treatment processes remain the same as with the Generalist condition.
16143783|NCT01829308|Behavioral|The brief interventions are delivered by the primary care provider (Generalist)|Primary care providers perform the brief intervention. The screening and referral to treatment processes remain the same as with the Specialist condition.
16143784|NCT01829295|Drug|Mycophenolate mofetil|For the first two weeks, an introductory dose of 500 mg BID orally. After two weeks, the dose will be increased to 1.5 g BID.
16143785|NCT01829295|Drug|Methotrexate|For the first two weeks, an introductory dose of 15 mg/week (7.5mg BID once a week) orally. After two weeks, the dose will be increased to 25 mg/week (12.5mg BID once a week)
16143786|NCT01829295|Drug|Prednisone|All patients enrolled in the study will be initially taking concomitant oral corticosteroids at 1 mg/kg or 60 mg daily, whichever is less. Initial corticosteroid dose will be continued for 2 to 4 weeks at which point prednisone will be gradually tapered. Prednisone will be tapered to and held at 7.5 mg/day for the first 6 months of the study.
16143787|NCT01829282|Behavioral|Risk Reduction|
16143788|NCT01829256|Behavioral|Pharmacist telehealth intervention|A tailored intervention with medication management and behavioral components. The behavioral modules may include, diet, exercise, weight, tobacco use, medication management, side effects, diabetes education, DKD/ HTN/ CVD risk and knowledge.Based on the patient's responses to a series of questions, there will be a provision of tailored feedback to reinforce evidence-based behavior for disease and lifestyle management.
16143789|NCT01829243|Drug|Milnacipran|
16143790|NCT01829243|Drug|Placebo|
16143791|NCT01829230|Device|1 Day Acuvue Moist|Lenses will be worn in a daily wear modality
16143792|NCT01829217|Drug|Sunitinib|
16143793|NCT01829191|Device|Soft Contact Test Lens A|FDA-approved, non-marketed daily disposable soft contact lens, conventional design
16143794|NCT01829191|Device|Soft Contact Test Lens C|Daily disposable soft contact lens with new optical design
16143795|NCT01829178|Drug|Silymarin|Silymarin 420 mg in 3 divided dose plus standard chemotherapy
16143796|NCT01829178|Drug|Placebo|placebo tablets: 420 mg in 3 divided dose
16143797|NCT01829178|Drug|chemotherapy|All patients will receive standard chemotherapy: cisplatin 50-60mg/m2 + fluorouracil 750 mg/m2 + docetaxel 60-80 mg/m2
16143798|NCT01829165|Device|rTMS Treatment|MRI-compatible TMS stimulator
16143799|NCT01829165|Device|Sham rTMS Treatment|
16143800|NCT01829152|Device|CHM|
16143801|NCT01829113|Drug|OGX-427|Three loading doses of 600mg OGX-427 will be administered intravenously (IV) during a 9 day period. Then 600mg IV OGX-427 will be given weekly on Days 1, 8 and 15 of each 21 day cycle prior to the administration of pemetrexed (500mg/m^2 IV) and carboplatin (AUC 6 IV) on Day 1 of each cycle for a maximum of four treatment cycles. Patients who respond to treatment or have stable disease will continue to receive 600 mg IV OGX-427 plus 500mg/m2 IV pemetrexed weekly until toxicity or disease progression.
16143802|NCT01829113|Drug|Placebo|Three loading doses of placebo will be administered intravenously (IV) during a 9 day period. Then placebo (IV) will be given weekly on Days 1, 8 and 15 of each 21 day cycle prior to the administration of pemetrexed (500mg/m^2 IV) and carboplatin (AUC 6 IV) on Day 1 of each cycle for a maximum of four treatment cycles. Patients who respond to treatment or have stable disease will continue to receive placebo (IV) plus 500mg/m2 IV pemetrexed weekly until toxicity or disease progression.
16143803|NCT01829100|Behavioral|Group Behavioral Activation Therapy (GBAT)|GBAT consists of 15 weekly, hour-long sessions. The first five group sessions teach four core BA principles: (a) psychoeducation of anxiety and depression, (b) functional analysis and identifying the maintaining role of avoidance, (c) problem solving and approach-oriented decision-making, and (d) graded exposures and behavioral activation. The second five group sessions consist of graded exposures or engagement exercises, where group members take turns practicing skills in role plays and in vivo exposures. Each youth receives two individual meetings (30-45 minutes) after the second and fourth group sessions. The first individual meeting promotes engagement and motivation for the group; the second helps develop the youth's individual avoidance/challenge hierarchy.
16143804|NCT01829087|Drug|Botox|
16143805|NCT01829087|Drug|placebo|
16143806|NCT01829048|Drug|PF-02545920|15 mg (2 mg X 2d, 5 mg X 2d, 8 mg X 3 d, then 15 mg) Q12h
16143807|NCT01829048|Drug|PF-02545920|15 mg (5 mg X 2d, 10 mg X 2d, then 15 mg) Q12h
16143808|NCT01829048|Drug|PF-02545920|15 mg (5 mg BID for 7 days 10 mg BID for 7 days, then 15 mg BID for 4 days) Q12h
16143809|NCT01829048|Drug|Placebo|Placebo Q12h
16143810|NCT01829035|Other|Conventional Transarterial Chemoembolization (cTACE)|"Concurrent use of the following material/drug is defined as cTACE in this trial.
~Embolization material (e.g., gelatin sponges, porous gelatin particles, Ivalon, etc.) other than ethiodized oil
~Anti-tumor drug:
~Unapproved drug/embolization material from each regulatory agency should not be used.
~To chemo-embolize all arteries feeding viable lesions via super selective cTACE, which is more effective and can be recommended as it rarely causes impairment of non-cancerous liver tissues. After assessing the disappearance of tumor stain as much as possible by angiography, the cTACE procedure should be completed"
16143811|NCT01829022|Procedure|E-NOTES|Embryonic-Natural Orifice Transumbilical Endoscopic Surgery for Myomectomy with Traction of Multidirectional Sutures
16143812|NCT01829009|Other|Resistance Exercise Group|"An individualized resistance exercise program wil be applied twice a week by an expert physiotherapist. Every 2 weeks, intensity will be reassessed by the same physiotherapist. Weekly, participants will be asked about incidents such as the occurrence of falls or hospitalizations during this study period.
~Physical performance and functional status will be assessed by the blind investigator at weeks 6,12 and 24"
16143813|NCT01828996|Device|Shock wave therapy|A total of 3000 pulses will be applied, moving the shock head every 500 pulses to cover the entire prostate and pelvic floor region.
16143814|NCT01828996|Device|Placebo|A total of 3000 pulses will be applied, moving the shock head every 500 pulses to cover the entire prostate and pelvic floor region
16143815|NCT01828983|Behavioral|Telephone support groups|
16143816|NCT01828983|Other|Education webinars|
16143817|NCT01828970|Drug|Basal-bolus detemir-aspart insulin regimen|After the first CGM was completed during the conventional anti-diabetic treatment, patients received a rapid-acting insulin analogue before each meal (i.e., aspart) and a basal long-acting insulin analogue (i.e., detemir) once or twice daily. The analogues were titrated for optimal glycemic control. After one month of the aspart and detemir regimen, a physician adapted the insulin doses according to the glucose values observed from the second CGM.
16143818|NCT01828957|Biological|Pneumostem®|
16143819|NCT01828957|Other|Normal Saline|
16143820|NCT01828944|Dietary Supplement|olive oil|
16143821|NCT01828931|Behavioral|Lifestyle Intervention|A lifestyle intervention (LI) aimed at reducing caloric intake and increasing physical activity
16143822|NCT01828931|Other|Usual Care|Care as usual
16143823|NCT01828918|Genetic|microRNAs|
16143824|NCT01828905|Device|"CERAMENT™|BONE VOID FILLER"|ceramic bone void filler
16143825|NCT01828905|Procedure|Autologous cancellous bone graft|autologous cancellous bone graft
16143826|NCT01828892|Procedure|Endoscopy exploration and glue application|A forward-viewing fistula-fiberscope (EndoView, Outai Medical Equipment, Shanghai, China), with 15cm length and 5mm width of fiber optical wire, was inserted into the fistula tract to accomplish endoscopic visualization. Briefly, the fistula-fiberscope assisted procedure was carried out percutaneously, allowing the exposure of internal hole and the whole tracts, followed by insertion of this catheter with distal mixing device.
16143827|NCT01828892|Procedure|Endoscopy exploration|A forward-viewing fistula-fiberscope (EndoView, Outai Medical Equipment, Shanghai, China), with 15cm length and 5mm width of fiber optical wire, was inserted into the fistula tract to accomplish endoscopic visualization.
16143828|NCT01828892|Drug|Antibiotics (ceftazidime, cefotaxime, or meropenem, with or without vancomycin)|Antibacterial therapy in patients with signs of systemic sepsis or local inflammation with pain
16143829|NCT01828892|Dietary Supplement|Nutrition support|Nutritional replacement and bowel rest via enteral or parenteral nutrition
16143830|NCT01828879|Drug|Tacrolimus|Tacrolimus ointment, 0.1 percent will be applied twice daily, in adult population for 4 weeks or until 1 week after the affected areas defined for treatment at baseline are completely cleared, whichever is first.
16143831|NCT01828866|Behavioral|EMDR|EMDR is a protocolized, evidence-based treatment for PTSD. Here we use it to target addiction memory representations that elicit craving and may influence drinking behavior. The EMDR study protocol is based on the standard EMDR protocol and other EMDR approaches used in addiction.
16143832|NCT01828866|Behavioral|Community Reinforcement Approach|"CRA is based on behavioural therapy principles:
~Functional analysis
~Communication skills
~Problem-solving skills
~Sobriety sampling
~Social networking
~Refusal of substances
~Reinforcing activities
~Relapse management
~Medication monitoring"
16143833|NCT01828840|Drug|epidural morphine via PCEA|
16143834|NCT01828840|Drug|epidural fentanyl via PCEA|
16143835|NCT01828840|Drug|epidural methadone via PCEA|
16143836|NCT01828840|Drug|intravenous morphine via PCA|
16143837|NCT01828827|Drug|PA-824 1000 mg|Two single administrations of 1000mg each administered by 5 tablets of 200mg, one administered in the fed state and one administered in the fasted state.
16143838|NCT01828801|Device|Pinnacle Metal-on Metal|All patients that are post-operative will have undergone total hip arthroplasty with the Pinnacle Metal-on-Metal device
16143839|NCT01828788|Drug|Ropivacaine|
16143840|NCT01828788|Drug|placebo|
16143841|NCT01828775|Other|palliative care|Receive early PCI
16143842|NCT01828775|Other|palliative care|Receive delayed PCI
16143843|NCT01828775|Procedure|quality-of-life assessment|Ancillary studies
16143844|NCT01828775|Other|survey administration|Ancillary studies
16143845|NCT01828762|Biological|DC-TC+GM-CSF|
16143846|NCT01828736|Biological|Trastuzumab|Bottles of 150 mg; Charging dose: 8mg/kg then 6mg/kg every 21 days given IV
16143847|NCT01828736|Drug|Gemcitabine|Given IV, 1000 mg/m² BSA on Day 1 and Day 8 every 21 days
16143848|NCT01828736|Drug|Carboplatin|Given IV: AUC 5 on Day 1 every 21 days
16143849|NCT01828736|Drug|Cisplatin|Given IV, 70 mg/m² BSA on day 1 every 21 days
16143850|NCT01828723|Biological|SVF|
16143851|NCT01828710|Dietary Supplement|Myo-inositol normospermic|4000mg/die of myo-inositol and 400 µg of folic acid (Inofolic® Lo.Li. pharma s.r.l., Roma) for three months.
16143852|NCT01828710|Dietary Supplement|Myo-inositol OAT|B 13 OAT patients treated with 4000mg/die of myo-inositol associated to 400 µg of folic acid (Inofolic® Lo.Li. pharma s.r.l., Roma) for three months
16143853|NCT01828710|Dietary Supplement|Folic Acid normospermic|Group C 20 normospermic patients treated with 400 µg of folic acid (kindly provided by Lo.Li. pharma s.r.l., Roma) for three months.
16143854|NCT01828697|Drug|Low dose nadroparin|"Fixed low dose nadroparin:
~< 100 kg: 2850 IU subcutaneously once-daily
~100 kg and above: 3800 IU subcutaneously once-daily"
16143855|NCT01828697|Drug|Intermediate dose nadroparin|"Intermediate weight-adjusted dose nadroparin:
~< 50 kg: 3800 IU subcutaneously once-daily;
~50 to < 70 kg: 5700 IU subcutaneously once-daily;
~70 to < 100 kg: 7600 IU subcutaneously once-daily;
~100 kg or above: 9500 IU subcutaneously once-daily."
16143856|NCT01828697|Drug|Low dose enoxaparin|"Fixed low dose enoxaparin:
~< 100 kg: 40 mg subcutaneously once-daily
~100 kg and above: 60 mg subcutaneously once-daily"
16143857|NCT01828697|Drug|Intermediate dose enoxaparin|"Intermediate weight-adjusted dose enoxaparin:
~< 50 kg: 60 mg subcutaneously once-daily, or;
~50 kg to < 70 kg: 80 mg subcutaneously once-daily, or;
~70 kg to < 100 kg: 100 mg subcutaneously once-daily, or;
~100 kg or above: 120 mg subcutaneously once-daily."
16143858|NCT01828697|Drug|Low dose dalteparin|"Fixed low dose dalteparin:
~< 100 kg: 5000 IU subcutaneously once-daily
~100 kg and above: 7500 IU subcutaneously once-daily"
16143859|NCT01828697|Drug|Intermediate dose dalteparin|"Intermediate weight-adjusted dose dalteparin:
~< 50 kg: 7500 IU subcutaneously once-daily, or;
~50 kg to < 70 kg: 10000 IU subcutaneously once-daily, or;
~70 kg to < 100 kg: 12500 IU subcutaneously once-daily, or;
~100 kg or above: 15000 IU subcutaneously once-daily."
16143860|NCT01828697|Drug|Fixed low dose tinzaparin|"Fixed low dose tinzaparin:
~< 100 kg: 3500 IU subcutaneously once-daily
~100 kg and above: 4500 IU subcutaneously once-daily"
16143861|NCT01828697|Drug|Intermediate dose tinzaparin|"Intermediate weight-adjusted dose tinzaparin:
~< 50 kg: 4500 IU subcutaneously once-daily, or;
~50 kg to < 70 kg: 7000 IU subcutaneously once-daily, or;
~70 kg to < 100 kg: 10000 IU subcutaneously once-daily, or;
~100 kg or above: 12000 IU subcutaneously once-daily."
16143862|NCT01828684|Other|Therapeutic Lens Coating|Subjects will wear a therapeutic lens coating for 2 weeks.
16143863|NCT01828684|Other|Sham Lens Coating|Each subject will wear a sham lens coating for 2 weeks.
16143864|NCT01828671|Other|Oral Glucose Solution 296 mls|Should the participant be eligible to participate, they will be scheduled for two separate study visits to assess the glycemic response of the oral glucose solution.
16143865|NCT01828671|Other|Corn Tortilla|Should the participant be eligible to participate, they will be scheduled for a study visit to assess the glycemic response of the corn tortillas.
16143866|NCT01828671|Other|Low Soy Flour Corn Tortilla|Should the participant be eligible to participate, they will be scheduled for a single study visit to assess the glycemic response of corn tortillas with a low amount of soy flour.
16143867|NCT01828671|Other|Moderate Soy Flour Corn Tortilla|Should the participant be eligible to participate, they will be scheduled for a single study visit to assess the glycemic response of corn tortillas with a moderate amount of soy flour.
16143868|NCT01828671|Other|High Soy Flour Corn Tortilla|Should the participant be eligible to participate, they will be scheduled for a single study visit to assess the glycemic response of corn tortillas with a high amount of soy flour.
16143869|NCT01828658|Other|Strict bioimpedance guided dry weight prescription|Post dialysis patient dry weight was exclusively prescribed using the ideal weight measured by the BCM device (+/- 1.1 Kg).
16143870|NCT01828645|Dietary Supplement|Carbohydrate plus whey protein enriched drink|The patients will drink 200 mL of the nutritional supplement (Jucy, Fresenius Kabi, Brazil) 2h before upper digestive endoscopy under sedation with propofol.
16143871|NCT01828632|Procedure|Respiratory Physical Therapy|Patients were randomly assigned to receive either a preoperative respiratory physiotherapy program (Intervention group, RPT) which included lung re-expansion (Incentive Spirometer, Voldyne5000, Teleflex medical USA) and respiratory muscle training (Threshold IMT, Respironics Inc. Pittsburgh, PA, USA) or usual care (Control group). Immediately after randomization the RPT group patients received detailed instructions about the training program and how correctly use the IMT and incentive spirometer devices. The patients trained daily, for 30 consecutive days. Each session consisted in 20 minutes of IMT and incentive spirometer. The patients adherence to the program was evaluated weekly by the physical therapist. Postoperative physical therapy was the same for both groups and consisted in lung re-expansion exercise with the aid of the incentive spirometer. Besides, patients were placed in sitting position rather than lying and early mobilization was stimulated.
16143872|NCT01828619|Procedure|modified BuFlu conditioning|The regimen consisted of hydroxyurea 80 mg/kg on d -10; cytorabine 2 g/m2 on d -9; busulfan 3.2mg/kg/day iv. ×3days( on d -8 to -6); Flu30mg/m^2 i.v.×5days(on d-6 to-2) and semustine 250 mg/m2 on d -3.
16143873|NCT01828606|Device|coban 2 system|"All centres will perform the pressure measurements with Picopress, Microlab Elettronica, Italy For mobility measurements all centres will be supplied with pedometers. For perometry the centres will use their own equipment
~According to protocol the materials are applied to the whole leg and the measuring devices are put in place"
16143874|NCT01828606|Device|coban lite system|"All centres will perform the pressure measurements with Picopress, Microlab Elettronica, Italy For mobility measurements all centres will be supplied with pedometers. For perometry the centres will use their own equipment
~According to protocol the materials are applied to the whole leg and the measuring devices are put in place"
16143875|NCT01828593|Other|Serum-derived bovine immunoglobulin protein isolate (SBI)|SBI is a specially formulated light-colored protein powder composed of immunoglobulin (IgG) and other serum proteins similar to those found in colostrum and milk. SBI does not contain any milk products such as lactose, casein, or whey. SBI is gluten-free, dye-free, and soy-free. SBI is manufactured in accordance with current Good Manufacturing Practice (cGMP) and FDA guidelines for medical food ingredients.
16143876|NCT01828593|Other|Placebo|Matching placebo
16143877|NCT01828580|Device|active laparoscope positioner (AutoLap)|
16143878|NCT01828567|Behavioral|Shared decision making with a Prevention Coach|A series of two phone sessions with a prevention coach. The first to engage the veteran to choose a preferred prevention program and link them to Patient Aligned Care Team (PACT), and a follow-up call one month later to assess the progress of the prevention plan.
16143879|NCT01828554|Drug|Xeloda|"Cycle 1: Days 1-7 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Ideal Body Weight to calculate dosage. Cycle 1, Day 8-No drug.
~Cycle 1: Days 9-15 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage. Days 16-21-No drug.
~Cycle 2 and greater: Days 1-14 (21 day cycle): 1250 mg/m2 Xeloda orally twice a day using Actual Body Weight to calculate dosage."
16143880|NCT01828541|Behavioral|Hypnosis|Patients in this group will receive standard care plus 4 sessions of hypnosis.
16143881|NCT01828541|Other|Standard of Care|
16143882|NCT01828528|Procedure|Sleeve gastrectomy|An intra-operative liver biopsy was performed in 20 patients
16143883|NCT01828515|Drug|Vilazodone|Participants will be randomized to either vilazodone or placebo titrated as follows: 10 mg x 7 days, 20 mg x 7 days and 40 mg x 5 days.
16143884|NCT01828515|Drug|Placebo|
16143885|NCT01828515|Drug|Hydrocortisone|Participants receive 160 mg x 4 days after vilazodone or placebo pre-treatment
16143886|NCT01828502|Behavioral|Education|Participants in both groups will receive education by the EPA on the danger of exposure to secondhand smoke and how exposure can be prevented.
16143887|NCT01828502|Behavioral|Cotinine Education|Those randomized to the active intervention will also be provided with education utilizing the cotinine test strip in conjunction with the education from the EPA.
16143888|NCT01828489|Drug|Randomisation course 1 mitoxantrone versus DaunoXome|In course one with cytarabine and etoposide either mitoxantrone (standard) or DaunoXome (experimental) is given as anthracycline.
16143889|NCT01828489|Drug|Randomisation course 2 ADxE versus FLADx|The second course is randomised to either ADxE (standard arm) or FLADx
16143890|NCT01828476|Drug|Abiraterone|ARM A(Abiraterone with ABT-263) and ARM B(Abiraterone with both ABT-263 and Hydroxychloroquine)
16143891|NCT01828476|Drug|ABT-263|ARM A(Abiraterone with ABT-263) and ARM B(Abiraterone with both ABT-263 and Hydroxychloroquine)
16143892|NCT01828476|Drug|Hydroxychloroquine|ARM B(Abiraterone with both ABT-263 and Hydroxychloroquine)
16143893|NCT01828463|Drug|Nitisinone|doses 1, 2, 4 & 8 mg plus no treatment arm
16143894|NCT01828437|Drug|Pyridoxine plus prednisolone|
16143895|NCT01828437|Drug|Prednisolone|
16143896|NCT01828411|Device|Transpharyngeal ultrasonography|Transpharyngeal Dopplerultrasonography (Device: iE33 xMatrix Philips). Assessment of cerebral blood flow by detection of blood flow velocities in the extracranial carotid arteries.
16143897|NCT01828411|Device|Duplex sonography|Assessment of cerebral blood flow by detection of blood flow velocities in the extracranial carotid and middle cerebral arteries during coronary artery bypass grafting.
16143898|NCT01828398|Device|real-tDCS + UE robot-assisted therapy|
16143899|NCT01828398|Device|sham-tDCS + UE robot-assisted therapy|
16143900|NCT01828385|Drug|Magnesium Sulfate|Magnesium sulfate + rocuronium + sugammadex
16143901|NCT01828385|Drug|Saline|Saline + rocuronium + sugammadex
16144114|NCT01826916|Drug|DX-88 (ecallantide)|solution for injection 10 mg/mL
16143902|NCT01828372|Other|additional blood withdrawals|Blood withdrawals by either venous puncture or placement of permanent venous catheter.
16143903|NCT01828359|Drug|Amosartan® tab|comparison of different combination of anti-hypertension drug
16143904|NCT01828359|Drug|Cozaar® plus pro tab|comparison of different combination of anti-hypertension drug
16143905|NCT01828346|Drug|Birinapant|"Dose escalation part: (Drug escalation dose levels)
~Dose Level (1) - 13mg/m2 (twice a week for 3 of 4 weeks)
~Dose Level (-1) - 11 mg/m2 (twice a week for 3 of 4 weeks)
~Dose Level (2) - 13mg/m2 (twice weekly x 4 weeks)
~Dose Level (3a) - 17mg/m2 (twice weekly × 4 weeks)OR
~Dose Level (3b) - 17mg/m2 (twice a week for 3 of 4 weeks)"
16143906|NCT01828346|Drug|5-Azacitidine|Dose Level (0) - 75mg/m2 daily
16143907|NCT01828333|Other|No intervention|No intervention
16143908|NCT01828320|Behavioral|Cognitive Behavior Therapy for Insomnia, Interpersonal and Social Rhythms Therapy, Chronotherapy|
16143909|NCT01828320|Behavioral|Psychoeducation|
16143910|NCT01828307|Behavioral|Motivational enhancement therapy (MET)|MET is a client-centered, directive method of enhancing intrinsic motivation for change by exploring and resolving ambivalence. In this intervention MET will focus on exercise.
16143911|NCT01828307|Behavioral|Contingency management|Contingency management is a behavioral treatment that utilizes extrinsic motivation by offering individuals tangible rewards such as prizes for completion of specific target behaviors. The target behavior in this study is exercise.
16143912|NCT01828307|Behavioral|Standard Aftercare Treatment|Aftercare includes the following topics: substance use, high-risk situations, coping and life skills training, focus groups for depression and anxiety, and AIDS education.
16143913|NCT01828294|Drug|Subcutaneous immunoglobulins|Immunoglobulins used subcutaneously for maintenance of other immune mediated disorders.
16143914|NCT01828281|Device|CPAP|All subjects will undergo ultrasound examination of the abdomen the day after overnight polysomnography (PSG) and then at 3 months after completion of therapeutic or subtherapeutic CPAP treatment of 4 cm water.
16143915|NCT01828255|Device|SENSIMED Triggerfish®|
16143916|NCT01828242|Behavioral|Empowerment model to improve dietary intake|Empowerment model using specific guidelines to improve dietary intake
16143917|NCT01828242|Other|Control group following conventional approach|Control group following conventional approach
16143918|NCT01828229|Behavioral|female inactivity and hypercaloric diet|female inactivity and hypercaloric diet for 2 weeks
16143919|NCT01828229|Behavioral|inactivity|inactivity for 2 weeks
16143920|NCT01828229|Behavioral|inactivity and hypercaloric diet|inactivity and hypercaloric diet for 2 weeks
16143921|NCT01828229|Behavioral|normal activity and hypercaloric diet|normal activity and hypercaloric diet for 2 weeks
16143922|NCT01828229|Behavioral|inactivity and iso-caloric diet|inactivity and iso-caloric diet for 2 weeks
16143923|NCT01828216|Device|Home sleep study|The home sleep study is a pocket-sized digital recording device. It is a multi-channel screening tool that measures airflow through a nasal cannula connected to a pressure transducer, providing an apnea-hypopnea index (AHI) based on recording time. It also detects both respiratory and abdominal efforts through the effort sensor and can differentiate between obstructive and central events
16143924|NCT01828216|Device|conventional polysomnography|conventional type I sleep study according to international guidelines
16143925|NCT01828203|Drug|Minocycline|
16143926|NCT01828203|Drug|Placebo|
16143927|NCT01828203|Procedure|Surgical spinal cord decompression|Surgical decompression by means at the discretion of the clinical management team will occur within 24 hours of injury in all subjects. Stabilization will occur at that time but may also include further interventions at a later time.
16143928|NCT01828203|Procedure|Maintenance of minimum mean arterial pressure (MAP)|Standardized hemodynamic management protocol aimed at maintaining MAP ≥ 85 mm Hg for 7 days using volume augmentation with isotonic crystalloid followed by inotropic support if needed will be applied to all subjects.
16143929|NCT01828190|Other|Hyperbaric oxygen|HBOT will be given for 40 sessions of 2 atmospheres for 90 minutes each session, 5 times a week (2 months). TNF alpha blocker therapy will remain the treatment received before recruitment.
16143930|NCT01828177|Drug|PDI-320|
16143931|NCT01828177|Drug|PDI-320 Monad #1|
16143932|NCT01828177|Drug|PDI-320 Monad #2|
16143933|NCT01828177|Drug|Vehicle|
16143934|NCT01828164|Device|Ultrasound|The Aevo System™ is an ultrasound emitting dental device.
16143935|NCT01828164|Device|Sham comparator|Ultrasound not activated in the comparator side of the device.20 minutes per day of ultrasound treatment on the active side of the device. The device consists of a mouth guard type device with transducers embedded in the mouth guard. In the split mouth design, the treatment arm consist of the side of the mouth with the transducers activated while the comparator arm has the transducers deactivated.
16143936|NCT01828151|Device|Noninvasive ventilation mask|
16143937|NCT01828138|Dietary Supplement|Sodium|supplemental sodium tablets 150-200 mmol/day in 5 days
16143938|NCT01828138|Dietary Supplement|Placebo|Placebo are given in 5 days
16143939|NCT01828125|Procedure|Hypoglycaemic hyperinsulinemic clamp|A first catheter will be inserted for infusion of D-[6,6-2H2] glucose and insulin. A second catheter will be inserted for infusion of dextrose. Dextrose infusion will be enriched with D-[6,6-2H2] glucose. A third catheter will be inserted for sampling. D-[6,6-2H2] glucose will be administered as a priming dose followed by a constant infusion throughout the experiment. Insulin will be administered as a primed continuous infusion. The first two hours will serve as an equilibration period for the tracer while glucose infusion will be adjusted to achieve a plasma glucose concentration of 5 mmol/L. The third hour is considered the baseline period. Following this, dextrose infusion rate will be decreased over a period of 1 hour to attain hypoglycaemia with a target blood glucose level at 2.8 mmol/L. At the end of the fourth hour, a subcutaneous glucagon dose will be given and plasma samples will be drawn for the determination of labelled and unlabelled glucose, plasma insulin and glucagon.
16143940|NCT01828125|Drug|Glucagon|
16143944|NCT01828099|Drug|Ceritinib|Ceritinib was administered orally once-daily fasted at a dose of 750 mg capsules on a continuous dosing schedule. Ceritinib (LDK378) was the investigational treatment and is referred to as the investigational study treatment/drug.
16143945|NCT01828099|Drug|Pemetrexed|Pemetrexed was administered at a dose of 500 mg/m2 as an iv infusion on Day 1 of each 21-day cycle to patients randomized to the chemotherapy arm.
16143946|NCT01828099|Drug|Cisplatin|Cisplatin was administered by IV at a dose of 75 mg/m2 every 21 days for up to 4 cycles.
16143947|NCT01828099|Drug|Carboplatin|Carboplatin was administered as iv infusion (AUC 5-6) every 21 days up to 4 cycles
16143948|NCT01828086|Biological|CJM112|Monoclonal antibody
16143949|NCT01828086|Biological|Secukinumab|Monoclonal antibody
16143950|NCT01828086|Other|Placebo|Liquid for subcutaneous injection without active drug.
16143951|NCT01828073|Drug|Raltegravir|No study-specific drugs were given to women or infants during this study. Women received RAL for clinical indications outside of the study.
16143952|NCT01828060|Dietary Supplement|Jobelyn™|Sorghum bicolor leaf sheath extract
16143953|NCT01828060|Dietary Supplement|Placebo|Placebo capsules
16143954|NCT01828047|Device|orthogonal polarization spectral (OPS) imaging|orthogonal polarization spectral (OPS) imaging allows noninvasive observation of human microcirculation in all accessible tissue surfaces
16143955|NCT01828034|Drug|Gemcitabine|
16143956|NCT01828034|Drug|Cisplatin|
16143957|NCT01828034|Drug|MEK162|
16143958|NCT01828021|Biological|Margetuximab|Anti-HER2 monoclonal antibody
16143959|NCT01827995|Other|Self assessment|Intervention group: Simplified followup Mifepristone at outpatient clinic, followed by the administration of misoprostol 24-48 hours later (in the clinic or at home). The women will not return to the clinic for routine follow up visit, but are given instructions on how to use a checklist and a low sensitivity pregnancy test around day 10-14. They are asked only to return if they have any health problems or screen positively. The low sensitivity urinary-hCG (with HCG of 1000 IU/ml) test will be used. Women will be provided the pregnancy test free of cost along with a pictorial checklist. A research assistant or a nurse will explain in detail how to use the pregnancy test as well as the checklist, and provide phone numbers in case of any questions or doubts. Follow-up interviews will be conducted through home visits or phone (if woman has one) during the next 1-2 days to screen for on-going pregnancies and assess acceptability the self-assessment.
16143960|NCT01827995|Other|Routine assessment|Follow up in the clinic
16143961|NCT01827982|Drug|JNJ-54861911 1mg|JNJ-54861911 1 mg will be administered as a single oral dose after an overnight fast of at least 10 hours.
16143962|NCT01827982|Drug|JNJ-54861911 3 mg|JNJ-54861911 3 mg will be administered as a single oral dose.
16143963|NCT01827982|Drug|JNJ-54861911 9 mg|JNJ-54861911 9 mg will be administered as a single oral dose.
16143964|NCT01827982|Drug|JNJ-54861911 27 mg|JNJ-54861911 27 mg will be administered as a single oral dose.
16143965|NCT01827982|Drug|JNJ-54861911 81 mg|JNJ-54861911 81 mg will be administered as a single oral dose.
16143966|NCT01827982|Drug|JNJ-54861911 160 mg|JNJ-54861911 160 mg will be administered as a single oral dose.
16143967|NCT01827982|Drug|JNJ-54861911 tbd|The dose of JNJ-54861911 will be derived from the results obtained in Parts 1 and 2.
16143968|NCT01827982|Drug|JNJ-54861911 9 mg|Study drug will be administered after an overnight fast of at least 10 hours and within 120 minutes after placement of the spinal catheter.
16143969|NCT01827982|Drug|Placebo|Matching placebo will be given as a single oral dose.
16143970|NCT01827969|Procedure|ablathermy focused ultrasound|ablathermy focused ultrasound
16143971|NCT01827956|Other|Blood sample for identifying the polymorphism|Blood sample for identifying the polymorphism
16143972|NCT01827943|Drug|Temsirolimus|Temsirolimus
16143973|NCT01827930|Drug|Imatinib Mesylate 600 MG Oral Tablet|Imatinib Mesylate for CP CML
16143974|NCT01827930|Drug|Imatinib Mesylate 400 MG Oral Tablet|Imatinib Mesylate for CP CML
16143975|NCT01827930|Drug|Imatinib Mesylate|Imatinib Mesylate for CP CML
16143976|NCT01827917|Biological|rabies vaccine|Injection on day 0、7、21
16143977|NCT01827904|Device|Transcranial ExAblate|
16143978|NCT01827904|Device|Sham Transcranial ExAblate|
16143979|NCT01827891|Procedure|remote ischemic preconditioning (RIPC)|Those randomized to RIPC group had a pneumatic medical tourniquet cuff (width , 5 cm ; length , 40 cm) placed around their upper arm at < 2 hours before the PCI procedure. The pneumatic medical cuff was inflated to a pressure of 200 mm Hg for 5 minutes , followed by 5 minutes of deflation to allow reperfusion. This procedure was repeated for 3 times.
16143980|NCT01827878|Drug|Lisinopril and Hydrochlorothiazide Tablets (20+25) mg|Lisinopril and Hydrochlorothiazide (20+25) mg Tablets once a day
16143981|NCT01827878|Drug|Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets|Zestoretic® 20/25 lisinopril/hydrochlorothiazide Tablets once a day
16143982|NCT01827865|Drug|Etodolac Extended Release Tablets USP 600mg|Etodolac Extended Release Tablets USP 600mg once a day
16143983|NCT01827865|Drug|Etodolac Extended Release Tablets 600mg|Etodolac Extended Release Tablets 600mg once a day
16143984|NCT01827839|Biological|Herpes Zoster vaccine (GSK1437173A)|2 doses administered intramuscularly in deltoid region of non-dominant arm.
16143985|NCT01827826|Behavioral|Telephonic intervention to prevent Diabetes Mellitus, Type 2|Participants assigned to the intervention group received a total of 16 phone calls from the study interventionist over 24 weeks. The first 12 weeks was the intervention phase and calls were made weekly. The second 12 weeks was the maintenance phase and calls were made every 3 weeks. After 24 weeks, the investigators continued to follow this group for 52 weeks post-randomization, allowing half of the group to continue to receive monthly maintenance calls while the other half received no further calls. The study interventionist used behavior modification techniques to encourage intervention group participants to adopt healthy eating and exercise habits so that improvement might be seen in fasting glucose, glycated hemoglobin (HbA1c), weight, and waist/hip measurements.
16144014|NCT01827644|Drug|Afuresertib ECT - Fed State|White to off white, round, biconvex coated tablet containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib ECT administered in fed state
16143986|NCT01827813|Procedure|Transrectal prostate biopsy with ultrasonography.|Transrectal prostate biopsy was performed in left lateral decubitus position with sedo-analgesia in saturation biopsy group and without sedoanalgesia in 10-12 core biopsy group on outpatient basis. After preparation of the rectal ultrasound probe and assuming an appropriate position, ultrasonographic examination of the prostate was performed on axial and sagittal plane. Periprostatic block was performed with the injection of 3 cc of prilocaine to each of the right and left lobes in the right and left periprostatic region in both groups before biopsy. Biopsy procedure was performed with an 18 G, 20 cm tru-cut biopsy needle and an automatic biopsy gun. After passing beyond the rectal mucosa, the needle was advanced until 0.5 cm proximal to the area of interest by tracking the image of the needle on the screen.
16143987|NCT01827813|Procedure|Periprostatic block|Periprostatic block was used for local anesthesia. 3 cc 2% prilocaine was injected to both periprostatic region in both saturation biopsy and 10-12 core biopsy group with transrectal ultrasonography.
16143988|NCT01827813|Procedure|Sedoanalgesia|Sedoanalgesia was used in saturation biopsy group. It was given by an anesthesiologist. Patients were given adequate counselling regarding sedoanesthesia as well as the biopsy procedure. They were advised to fast the night before the procedure.Before induction of sedoanalgesia all patients were monitorized for peripheric oxygen saturation and electrocardiography (ECG).Additionally nasal oxygen with 3ml/min was given to all patients by nasal canula.Sedoanalgesia was induced with 0.05mg/kg of midazolam, 1mg/kg of propofol and 1mg/kg of fentanyl. additional propofol was given with dose of 0.3mg/kg as patients needed.
16143989|NCT01827800|Behavioral|eHealth weight loss intervention|This trial involves a multi-level, systems-change weight loss intervention. At the provider level, we make it easier for PCPs to deliver weight loss counseling by embedding patient progress data and counseling recommendations in the electronic health record. At the patient level, we provide engaging self-monitoring interfaces, immediate tailored feedback, skills training, and evidence-based lifestyle counseling from trusted care providers.
16143990|NCT01827787|Drug|Eribulin|
16143991|NCT01827774|Device|Surgisis® Soft Tissue Graft|Surgisis® Soft Tissue Graft for pelvic organ prolapse repair
16143992|NCT01827761|Behavioral|Questionnaire|After informed consent for this study is obtained, patients will be given questionnaire #1 that includes rating their knowledge of the side effects of treatment, their understanding of the treatment schedule, what do in the event of complication, how to reach the medical team and an assessment of the level of anxiety. The questionnaire will be repeated at day 1 of the first chemotherapy treatment to assess the effectiveness of the teaching session. In addition, questionnaire #3 will be administered at day 1 of cycle 2 of their first chemotherapy.
16143993|NCT01827748|Device|Intraoperative Autorefractor IAR-1|This is an auto-refractor mounted on an operating microscope and used with the subject in a supine position
16143994|NCT01827748|Device|Hartmann-Shack Auto Refractor|Standard auto-refractor used with subject sitting upright in front of the instrument.
16143995|NCT01827735|Drug|Aldesleukin (Proleukin)|A single, subcutaneous dose will be given administered with the maximum dose allowed 1.5 X 106 IU/M2.
16143996|NCT01827722|Drug|Ozurdex|Intravitreal injection of Ozurdex
16143997|NCT01827722|Drug|Ranibizumab|Intravitreal Injection of Ranibizumab
16143998|NCT01827722|Drug|Combination Ozurdex with Ranibizumab PRN|Intravitreal Injection of combination medication Ozurdex and Ranibizumab
16143999|NCT01827709|Other|A polymerase chain reaction -based hypoxia classifier|"Recently, a polymerase chain reaction (PCR) -based hypoxia classifier gene signature was published that can be easily applied. Using this classifier, patients will be divided in hypoxic or non-hypoxic subgroups.
~These subgroups will be correlated to locoregional control. The hypoxic signature will also be related to parameters on DCE-MRI, DWI and FDG-PET."
16144000|NCT01827709|Other|Functional imaging before treatment.|As part of the standard staging procedure all patients will undergo an MRI of the neck. We will however also take DWI and DCE images at this time point. Parameters of these images will be later on correlated with pathology.
16144001|NCT01827709|Other|Immunohistochemical staining|At 3 levels of the tumour, chosen by the radiologist on the functional imaging modalities, 4µm thick slices will me taken. On each level an immunohistochemical staining will be carried out (GLUT-1, CA-IX, HIF-1alpha, VEGF, KI 67). The result of this staining will be correlated with parameters derived from the functional imaging modalities.
16144002|NCT01827709|Other|MRI of the resection specimen|To account for the shrinkage of the tumour due to fixation, the resection specimen will be placed in a box and scanned with an MRI. From this a shrinkage factor will be calculated using the original pre-treatment MRI.
16144003|NCT01827709|Other|Tumour volume delineation and comparison|On the imaging modalities the tumor volume will be delineated. This will also be done on the resection specimen. Later on the different tumour volumes will be correlated.
16144004|NCT01827696|Dietary Supplement|Ginseng|Effect of four weeks of daily Ginseng intake (2gm/day) on muscle soreness following downhill running exercise
16144005|NCT01827683|Other|Hyperbaric oxygen|8-week, 5 times a week administration of 100% O2 for 90 minutes at a pressure of 2 ATA.
16144006|NCT01827670|Drug|Stannous fluoride|Test dentifrice containing 0.454% SnF
16144007|NCT01827670|Drug|Sodium monofluorophosphate|Control dentifrice containing 0.76% w/w Sodium Monofluorophosphate [1000 parts per million (ppm) fluoride]
16144008|NCT01827657|Drug|GSK2336805|Two 30 mg GSK2336805 tablets for a 60 mg single dose will be administered in this study
16144009|NCT01827644|Drug|Afuresertib GC - Fasted State|White opaque hard gelatin capsule containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib GC administered in fasted state
16144010|NCT01827644|Drug|Afuresertib HPMC capsule - Fasted State|White opaque HPMC capsule containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib HPMC capsule administered in fasted state
16144011|NCT01827644|Drug|Afuresertib ECT - Fasted State|White to off white, round, biconvex coated tablet containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib ECT administered in fasted state
16144012|NCT01827644|Drug|Afuresertib GC - Fed State|White opaque hard gelatin capsule containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib GC administered in fed state
16144013|NCT01827644|Drug|Afuresertib HPMC capsule - Fed State|White opaque HPMC capsule containing afuresertib 25 mg. Subjects will receive single oral dose of afuresertib HPMC capsule administered in fed state
16144015|NCT01827631|Drug|GSK1605786 capsule|Swedish Orange, size 0, hard gelatine capsules
16144016|NCT01827618|Drug|Rapamycin|
16144017|NCT01827605|Other|ZEVALIN|Infusion of 90Y Ibritumomab Tiuxetan if the patient has less than 25% BM infiltration at the pre-consolidation restaging (0.4 mCi/kg if platelets ≥150,000/mmc, 0.3 mCi/kg if platelets are between 100.000 and 150,000/mmc).
16144018|NCT01827605|Drug|BEAM|"BEAM REGIMEN day -6 Carmustine* 300 mg/ m2 i.v. in 250ml dextrose 5% solution
~from day -5 to day -2 Cytarabine 200 mg/m2 i.v. every 12 hours in 250 ml dextrose 5% solution, 250 ml/hr Etoposide 100 mg/m2 i.v. every 12 hours in 250 ml dextrose 5% solution, 250 ml/hr day -1 Melphalan 140 mg/m2 i.v. in 100ml saline solution in 200 ml/hr
~day 0
~UReinfusion of autologous stem cells following this rules:
~Patient collecting ≥6x106 CD34+ cells/kg use >4x106 CD34+ cells/kg for ASCT and keep >2x106 CD34+ cells/kg for back up;
~Patient collecting 4-6x106 CD34+ cells/kg use >2x106 CD34+ cells/kg for ASCT and keep >2x106 CD34+ cells/kg for back up;
~Patient collecting 2-4x106 CD34+ cells/kg use all CD34+ cells for ASCT and keep no back up.
~day 2 Filgrastim or Lenograstim 5μg/Kg s.c. until ANC > 1500/mmc"
16144019|NCT01827592|Drug|Elobixibat 10 mg|Elobixibat 10 mg/day
16144020|NCT01827592|Drug|Elobixibat 5 mg|Elobixibat 5 mg/day
16144021|NCT01827592|Drug|Placebo|Placebo
16144022|NCT01827579|Biological|CD25/71 allodepleted donor T-cells|CD25/71 allodepleted donor T-cells will be administered at a dose of 10^5 /kg at day 30 post-SCT, 3 x 10^5 /kg at day 60 and 10^6 /kg at day 90 post transplant
16144023|NCT01827566|Other|gluten|
16144024|NCT01827566|Other|gluten free flour|
16144025|NCT01827553|Drug|Induction chemotherapy with gemcitabine or FOLFIRINOX|According to medical recommendation, induction chemotherapy is performed with gemcitabine (3 cycles a 3 administrations, 1000 mg/m^2/d)or FOLFIRINOX (6 cycles; 1 cycle: oxaliplatin 85 mg/m^2 2 h infusion, folinic acid 400 mg/ m^2 2h infusion completed after 30 min with irinotecan infusion 180 mg/m^2 for 90 minutes, bolus application 5-FU 400 mg/m^2 followed by 46h infusion of 5-FU 2400 mg/m^2)
16144026|NCT01827553|Radiation|Radiotherapy, 28 x 1.8 Gy|Radiotherapy combined with chemotherapy starts on day 1 of chemotherapy. Radiation volume is restricted to macroscopic visual tumor region. Radiation is performed in 28 fractions with 1.8 Gy resulting in a total dose of 50.4 Gy.
16144027|NCT01827553|Drug|Chemotherapy, gemcitabine|5 cycles of 300 mg/m^2/d gemcitabine infusions and than 3 administrations of 1000 mg/m^2/d
16144028|NCT01827553|Drug|Chemotherapy with gemcitabine or FOLFIRINOX according to induction chemotherapy|Chemotherapeutic administration started with during induction chemotherapy is continued; Gemcitabine: 3 cycles a 3 administrations of 1000 mg/m^2/d gemcitabine infusions FOLFIRINOX: 6 cycles
16144029|NCT01827540|Drug|Cenicriviroc|
16144030|NCT01827540|Drug|Dolutegravir|
16144031|NCT01827540|Drug|Midazolam|
16144032|NCT01827501|Device|PulsioflexTM Monitoring|Fluid and catecholamine management according to PulsioflexTM measurements
16144033|NCT01827475|Drug|Ibuprofen|single dose
16144034|NCT01827475|Drug|Acetaminophen|single dose
16144035|NCT01827475|Drug|Ibuprofen-acetaminophen combination|single dose
16144036|NCT01827462|Biological|Trivalent, inactivated influenza vaccine (TIV)|Licensed Seasonal Influenza Vaccine TIV
16144037|NCT01827462|Biological|Quadrivalent, inactivated influenza vaccine (IIV4)|Licensed Seasonal Influenza Vaccine IIV4
16144038|NCT01827462|Biological|High-Dose Trivalent, inactivated influenza vaccine (TIV High-Dose)|Licensed Seasonal High-Dose Influenza Vaccine TIV
16144039|NCT01827449|Device|Fluidotherapy warming device|Device uses airborne heated cellulose particles which are blown against the skin to provide convective warming.
16144040|NCT01827436|Behavioral|Conventional physical therapy|
16144041|NCT01827436|Behavioral|Asymmetrical gait training|
16144042|NCT01827423|Device|Surgical removal of sinonasal papiloma|An endoscopic endonasal surgical device is used to remove the sinonasal papilomas in the study subjects.
16144043|NCT01827410|Procedure|Ventral hernia repair|
16144044|NCT01827397|Biological|EN41-UGR7C HIV vaccine|
16144045|NCT01827397|Biological|NaCl|
16144046|NCT01827384|Drug|Adavosertib|Given PO
16144047|NCT01827384|Drug|Carboplatin|Given IV
16144048|NCT01827384|Drug|Everolimus|Given PO
16144049|NCT01827384|Drug|Temozolomide|Given PO
16144050|NCT01827384|Drug|Trametinib|Given PO
16144051|NCT01827384|Drug|Veliparib|Given PO
16144052|NCT01827371|Biological|MVA Smallpox Vaccine|Subjects receive two dose regimen of IMVAMUNE® (1x10^8 TCID50/0.5 mL per dose) via the SC route using either a syringe and needle or the Stratis™ system. Arm A receives doses via syringe and needle on days 1 and 29; Arm B receives doses via syringe and needle on days 1 and 15, Arm C receives doses via syringe and needle on days 1 and 22, Arm D receives doses via Stratis on days 1 and 29.
16144053|NCT01827358|Drug|Mupirocin calcium|Mupirocin calcium cream 2% applied topically to umbilicus and perianal area every 8 hours for 5 days, for a total of 15 applications
16144054|NCT01827358|Drug|Mupirocin calcium|Mupirocin calcium ointment 2% will be applied intranasally every 8 hours for 5 days, for a total of 15 applications
16144055|NCT01827345|Dietary Supplement|Vitamin D|Participants will take the Institute of Medicine's recommended daily dose of vitamin D (800 IU/day) for six months.
16144056|NCT01827332|Drug|Oxytocin|Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo prior to two individual sessions of MET.
16144057|NCT01827332|Drug|Saline|Subjects will be administered 40 IUs of oxytocin nasal spray or matching placebo prior to two individual sessions of MET.
16144058|NCT01827306|Drug|Biofreeze|
16144059|NCT01827293|Drug|Promethazine|
16144060|NCT01827293|Drug|Lorazepam|
16144061|NCT01827280|Drug|Vildagliptin|Vildagliptin 50mg/pill will be administered at 10 AM and at 6 PM also for 30 days.
16144062|NCT01827267|Drug|neratinib|
16144063|NCT01827267|Drug|temsirolimus|
16144064|NCT01827254|Other|sunitinib: observational study|Observational study evaluating patients who were treated with sunitinib in 1st line and in 3rd line
16144065|NCT01827241|Other|Chart Review|Retrospective and prospective data review of colonoscopy procedures, examination findings, resection techniques, and pathology reports.
16144066|NCT01827228|Other|Assays|May vary across sites
16144067|NCT01827228|Other|HIV medical care|This will be expedited and assisted via community outreach for Recents and Acutes
16144068|NCT01827228|Other|Social network and venue tracing|This is described in Arms 1 and 2
16144069|NCT01827228|Other|Community alerts|When we find recently or acutely infected participants, we will issue community alerts as described in Arm descriptions
16144070|NCT01827228|Other|Community education|Throughout the study we will educate affected communities about recent and acute HIV infection and about the importance of avoiding stigma
16144071|NCT01827228|Behavioral|HIV counseling|As part of HIV testing, we will provide participants with standard counseling
16144072|NCT01827215|Behavioral|Virtual Patient Advocate (VPA)|Intervention participants will have access to the Virtual Patient Advocate (VPA) system for a period of 12 months. They will be encouraged to log on every two weeks or twice a month, but frequency and duration of conversations with the VPA is at the discretion of the participant.
16144073|NCT01827202|Other|RAS blockade discontinuation|In the initial two weeks of the study, all RAS blockade will be eliminated from the subjects' antihypertensive regimen
16144074|NCT01827202|Drug|Aliskiren|
16144075|NCT01827202|Drug|Candesartan|
16144076|NCT01827189|Other|Comprehensive primary care|Practices participating in the comprehensive primary care initiative receive a monthly amount from Centers for Medicare and Medicaid Services for each attributed Medicare patient, plus technical support of a learning collaborative, and can share in any net savings generated.
16144077|NCT01827176|Other|Recurrent Acute Rhinosinusitis|Clinical Characteristic of Recurrent Acute Rhinosinusitis
16144078|NCT01827163|Drug|Paclitaxel|
16144079|NCT01827163|Drug|Trastuzumab|The q 3 week trastuzumab may be started at the last dose of paclitaxel infusion or from 1-3 weeks after the last dose of paclitaxel. Trastuzumab may also be administered at a dose of 6mg/kg during the last dose of paclitaxel in the THL phase.
16144080|NCT01827163|Drug|Lapatinib|
16144081|NCT01827163|Drug|Pegfilgrastim|Pegfilgrastim SQ is given on day # 2 of each paclitaxel cycle and may be dropped at the last paclitaxel infusion. Filgrastim may be used in lieu of pegfilgrastim at the physician's discretion.
16144082|NCT01827150|Drug|Redbull, energy drink|A can of 250 mL of the energy drink Redbull will be administered randomly to the subjects
16144083|NCT01827137|Biological|WT1 Analog Peptide Vaccine|Preparation of a suspension of liquid vaccine drug product preparation (100 mcg of each peptide x 4 WT1 peptides within the GPS mixture; total weight: 400 mcg) 1:1 v/v with Montanide (oil depot emulsifier) to a total volume of ~1 ml, which is then injected s.c. to the patient. GPS is administered subcutaneously with Montanide adjuvant, with the first dose within 22 days of ASCT with melphalan conditioning (200 mg/sq.m.) and biweekly administration thereafter, for a total of 6 initial doses. Subsequently, patients continued to receive booster GPS administrations every 4 weeks, for an additional set of 6 doses, assuming they remain non-progressors per International Myeloma Working Group (IMW) criteria and are also clinically stable.
16144084|NCT01827137|Biological|Sargramostim (GM-CSF)|Granulocyte-macrophage colony-stimulating factor (GM-CSF; Leukine®) is administered s.c. at a dose of 70 μg on day -2 and day 0 of each GPS administration.
16144085|NCT01827137|Drug|lenalidomide|IMiD (lenalidomide; 10 mg p.o. daily) OR -in select patients- proteasome inhibitor (bortezomib; 1.3 mg/sq.m. s.c. every 2 weeks) maintenance starting 3-months post auto SCT.
16144086|NCT01827124|Drug|Carbetocin|
16144087|NCT01827124|Drug|oxytocin|
16144088|NCT01827111|Drug|ABI-007|Starting dose of ABI-007 is 150 mg/m2 administered by vein on days 1, 8, 15 every 28 days. The cycle length for ABI-007 is 28 days.
16144089|NCT01827111|Drug|Ipilimumab|3 mg/kg by vein over 90 minutes on day 1. Ipilimumab dose repeated every 21 days for a total of 4 doses.
16144090|NCT01827111|Behavioral|Phone Call|Every 2 months for 6 months, then every 3 months for up to 2 years, participant contacted by telephone. Each call should last about 5 minutes.
16144091|NCT01827098|Procedure|Endodontic Regeneration|Blood clot formation is induced in the root canal after disinfection. Collagen material is placed over the clot. The canal access is sealed with white MTA and glass ionomer restoration. Permanent restoration is placed 3 months later on top of the MTA.
16144092|NCT01827085|Device|Conventional Macintosh laryngoscope|
16144093|NCT01827085|Device|Stortz videolaryngoscope|
16144094|NCT01827072|Drug|NPB-01|
16144095|NCT01827059|Drug|Bosentan|125-mg orange-white, round, biconvex, film-coated tablets
16144096|NCT01827059|Drug|Placebo|
16144097|NCT01827046|Drug|rt-PA|Up to 9 doses of 1.0 mg of rt-PA will be administered through the catheter that was placed directly into the intracerebral hemorrhage using minimally invasive surgery.
16144098|NCT01827033|Behavioral|meditation training|
16144099|NCT01827020|Drug|Lidocaine 2 %|12 mL lidocaine 2% 1mg/kg
16144100|NCT01827020|Drug|Ketamine plus Lidocaine|ketamine 0.5 mg/kg + Lidocaine 2% 1 mg/kg in total volume of 12 mL
16144101|NCT01827020|Drug|Saline|12 mL saline (0.9% isotonic solution)
16144102|NCT01827007|Other|Volume expansion with gelofusine|
16144103|NCT01826994|Device|heart type fatty acid binding protein testing|
16144104|NCT01826981|Drug|LDV/SOF|Ledipasvir/sofosbuvir (LDV/SOF) (90 /400 mg) fixed-dose combination (FDC) tablet administered orally once daily
16144105|NCT01826981|Drug|SOF|SOF 400 mg tablet administered orally once daily
16144106|NCT01826981|Drug|RBV|Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16144107|NCT01826981|Drug|Peg-IFN|pegylated interferon (Peg-IFN) 180 µg administered subcutaneously once weekly
16144108|NCT01826981|Drug|GS-9669|GS-9669 500 mg (2 × 250 mg tablet) administered orally once daily
16144109|NCT01826981|Drug|VEL|Velpatasvir (VEL) tablet(s) administered orally once daily
16144110|NCT01826968|Procedure|Alveolar Recruitment maneuver|In this group and during recruitment maneuver the investigators used pressure control ventilation and increased inspiratory time to 50%. The investigators used alveolar recruitment maneuver by increasing inspiratory pressure to 20 cmH20 and progressively increasing Positive Expiratory Pressure (PEEP) up to 45 cmH2O maximal (Ppeak) inspiratory pressure. The recruitment maneuver lasted 2 minutes. After the maneuver PEEP was set to 8 cmH2O and was left until the end of the operation. After the end of the recruitment maneuver volume control ventilation was used until the end of the operation too.
16144111|NCT01826942|Device|Lumenis UltraPulse single fractional CO2 laser treatment thin skin|
16144112|NCT01826942|Device|Single fractional CO2 treatment at surgical area closure procedure on thick skin|
16144113|NCT01826929|Other|Therapeutic education|
16144115|NCT01826890|Other|NAVA Technology|Use of NAVA technology: Diaphragmatic monitoring and NAVA ventilation mode
16144116|NCT01826877|Biological|AdGMCAIX-transduced autologous dendritic cells|Given ID
16144117|NCT01826877|Biological|therapeutic autologous dendritic cells|Given ID
16144118|NCT01826877|Other|laboratory biomarker analysis|Correlative studies
16144119|NCT01826864|Biological|sargramostim|Given SC
16144120|NCT01826864|Procedure|sentinel lymph node biopsy|Undergo sentinel lymph node biopsy
16144121|NCT01826864|Other|laboratory biomarker analysis|Correlative studies
16144122|NCT01826864|Other|hypertonic saline|Given SC
16144123|NCT01826851|Drug|Exparel|"Patients in this group will receive 266 mg Exparel diluted with 0.9% normal saline to a total volume of 50 mL and administered via parasternal intercostal nerve block prior to sternal closure.
~Post-operatively, patients will receive IV fentanyl as needed in the ICU while still intubated. A fentanyl PCA pump will be set up post-extubation as soon as possible and prior to the patient leaving the ICU."
16144124|NCT01826851|Drug|Placebo|"Patients in this group will receive 50 mL of 0.9% normal saline as a parasternal intercostal nerve block prior to sternal closure.
~Post-surgical pain management will be the same as for the Exparel group."
16144125|NCT01826838|Drug|Dasatinib|
16144126|NCT01826825|Behavioral|Cognitive Screen|Cognitive Screen
16144127|NCT01826825|Behavioral|Mini-Cog|Cognitive Screen
16144128|NCT01826812|Other|30 minutes sustained reading|The participants will be given a text to read silently in 30 minutes.
16144129|NCT01826812|Other|Dry eye exam|Tear break-up time, tear collection, osmolarity, Schirmer test, corneal and conjunctival staining.
16144130|NCT01826786|Drug|JNJ-42165279 (100 mg)|JNJ-42165279 (100 mg/day) will be orally administered once daily for 4 consecutive days.
16144131|NCT01826786|Drug|Placebo|Matching placebo to JNJ-42165279 will be orally administered once daily for 4 consecutive days.
16144132|NCT01826773|Drug|CardioPET™|CardioPET™ will be intravenously injected to each subject as a single radio-labeled dose of up to 8 mCi (296 MBq).
16144133|NCT01826760|Other|Using training and testing groups to construct ANN based on laboratory tests|
16144134|NCT01826747|Drug|crinone (progesterone 8%, vaginal application)|
16144135|NCT01826721|Other|Transplant Medication Information Teaching Tool|Online e-learning tool for post-transplant medication education.
16144136|NCT01826708|Biological|Identification of breakpoints|Identification of breakpoints in Molecular Biology : demonstration of a chimeric sequence corresponding to a junction region between the two chromosomes
16144137|NCT01826695|Other|Neurodynamic technique group|"Neurodynamic techniques are used in order to move most of the nerves between the neck and hand, including the median nerve, radial and ulnar, brachial plexus, spinal nerves and cervical nerve roots.
~The patient is placed supine position. The treatment will be carry out 3 times per week during 8 weeks."
16144138|NCT01826695|Other|Placebo group|Women in this group realized standard treatment in the Fibromyalgia Association without neurodynamic techniques.
16144139|NCT01826682|Other|Physiotherapy program+medical treatment|Patients included in this group are going to receive physiotherapy during their hospital stay 45 minutes every day. The physical training is based on respiratory exercises, the use of a flutter (positive expiratory pressure), pedaling and theraband exercises.
16144140|NCT01826682|Other|Medical treatment|Standard medical treatment without physiotherapy.
16144141|NCT01826669|Procedure|Stretching|Patients submitted to respiratory muscle stretching related to the increase thoracic mobility. Stretching were performed in the upper trapezius, scalenes, sternocleidomastoids, major pectoral and intercostals. The muscle stretching were performed passively by a single therapist trained and experienced. The subjects were positioned supine or lateral, knees flexed in order to correct the lumbar curve. Stretching occurred during the expiratory phase, leading to muscle maximum length, with two series of ten consecutive incursions for each muscle, with an interval of one minute between series. The patients were properly informed to perform slow exhalations and pursed-lip during stretching.
16144142|NCT01826656|Procedure|tooth extraction|Patients from both groups will follow the extraction of an hopeless tooth
16144143|NCT01826656|Radiation|CBCT scan|A CBCT scan will be performed within 2 days from the tooth extraction at after 3 months (+/-2 days)
16144144|NCT01826656|Radiation|DXA scan|DXA scan will be performed at the hip and lumbar spine in all self-reported non-osteoporotic subjects who hasn't done one within 1 year, to confirm their normal bone mineral density. Osteoporotic subjects already have a DXA scanner.
16144145|NCT01826656|Radiation|Panoramic radiograph|As basic standard of care, a panoramic radiograph will be performed to both test and control subjects who haven't done one within the previous year, in order to give them a full-mouth dental diagnosis
16144146|NCT01826630|Other|CLn BodyWash|Comparing two washes to determine change in bacterial load.
16144147|NCT01826630|Other|Cetaphil Daily Facial Cleanser|Comparing two washes to determine change in bacterial load.
16144148|NCT01826604|Device|Alexis O C-Section Retractor|The Alexis O C-section retractor will be used.
16144149|NCT01826604|Other|Control- Conventional retractors|Conventional hand-held retractors will be used. A self-retaining barrier retractor will not be used.
16144150|NCT01826591|Behavioral|Low-Carbohydrate Diet|Counseling/instruction on how to follow a low-carbohydrate diet.
16144151|NCT01826591|Behavioral|Low-Fat Diet|Counseling/instruction on how to follow a low-fat diet.
16144152|NCT01826591|Behavioral|Mobile App|Mobile app to increase vegetable consumption. Participants with iPhones will be re-randomized to receive a mobile app beginning at either months 4-5 or months 7-8. The first phase during months 4-7 will be used to compare the effect of a mobile app (intervention) vs. no mobile app (waiting-list control). The a priori hypothesis is that vegetable consumption will increase among those who receive the app in both diet groups.
16144153|NCT01826578|Procedure|using only one port for laparoscopic surgery|using only one port for laparoscopic surgery
16144154|NCT01826565|Procedure|Rotational technique|90 degree rotation
16144155|NCT01826552|Device|Osiro Hybrid Drug-Eluting Stent|Osiro Hybrid Drug-Eluting Stent (Biotronik AG, Bulach, Switzeland)
16144156|NCT01826552|Device|Resolute Integrity|Resolute Integrity zotarolimus-eluting stent (Medtronic Cardiovascular, CA, Minnesota, USA)
16144157|NCT01826539|Procedure|flap includes a donor nerve|the donor nerve is attached with the flap for sensory reconstruction of the finger
16144158|NCT01826526|Device|TauroSept®|"5 ml of TauroSept® will be instilled into the catheter (CVAD) each time after total parenteral nutrition (TPN) has been completed. The frequency of administration depends on the schedule of HPN. It varies between twice per week and once daily.
~The duration of TauroSept® administration in this trial will be 12 months."
16144159|NCT01826513|Device|Standard AutoSet algorithm|An AutoSet device with a standard algorithm developed for sleep breathing parameters that are specific to a particular gender.
16144160|NCT01826513|Device|Modified AutoSet algorithm|An AutoSet device with an algorithm developed for sleep breathing parameters specific to females.
16144161|NCT01826500|Other|blood test|blood test
16144162|NCT01826487|Drug|Ataluren|Ataluren will be administered as per the dose and schedule specified in the arm.
16144163|NCT01826487|Drug|Placebo|Placebo will be administered as per the schedule specified in the arm.
16144164|NCT01826474|Drug|PRO045, 0.15 mg/kg/week|Subcutaneous injection
16144165|NCT01826474|Drug|PRO045, 1.0 mg/kg/week|Subcutaneous injection
16144166|NCT01826474|Drug|PRO045, 3.0 mg/kg/week|Subcutaneous injection
16144167|NCT01826474|Drug|PRO045, 6.0 mg/kg/week|Subcutaneous injection
16144168|NCT01826474|Drug|PRO045, 9.0 mg/kg/week|Subcutaneous injection
16144169|NCT01826474|Drug|PRO045, selected dose|Subcutaneous injection
16144170|NCT01826461|Drug|PDI-192|
16144171|NCT01826461|Drug|Vehicle|
16144172|NCT01826448|Drug|PLX3397|
16144173|NCT01826448|Drug|vemurafenib|
16144174|NCT01826435|Behavioral|Electronic Intervention|Patients will be able to receive the intervention notifications over the electronic/multimedia mode they prefer; selecting either text messaging/mobile web and/or email/online web. Text message or email alerts with an included uniform resource locator (URL) link to the specified mobile or online web site will be utilized to notify patients of a pending encounter available on mobile. Topics that will be addressed in the intervention include medication and side effects, social support, hypertension knowledge, memory and smoking. All intervention encounters that are designed to collect responses from the patient will require the patient to supply credentials before responding to the encounter; thus, ensuring privacy of the patient session, as well as patient-specific tracking of responses.
16144175|NCT01826422|Dietary Supplement|EPA and DHA|Each capsule contains 225mg of DHA, 45mg of EPA, other omega 3 fatty acids 20mg.
16144176|NCT01826422|Dietary Supplement|Placebo Comparator|Placebo capsules will contain gelatin and sunflower oil. Fatty acid composition is as follows: lauric (C12:0), 0.19%; myristic (C14:0), 0.29%; palmitic (C16:0), 7.59%; palmitoleic (C16:1), 0.25%; stearic (C18:0), 3.49%; oleic (C18:1), 31.08%; linolenic (C18:3), 1.13%; linoleic (C18:2), 55.64%; DHA 0.02%; arachidic (C20:0), 0.30% and arachidonic (C20:4), 0.01%.
16144177|NCT01826409|Dietary Supplement|Fermented Red Ginseng|Fermented red ginseng 2.7g/day for 4 weeks
16144178|NCT01826409|Dietary Supplement|Placebo|Placebo 2.7g/day for 4 weeks
16144179|NCT01826396|Drug|Irinotecan|Comparison of standard and high dose irinotecan
16144180|NCT01826383|Behavioral|Active-Video|This group will watch an active-video with pain management strategies for parents
16144181|NCT01826383|Behavioral|Placebo Video|This group will watch a placebo-video describing immunization generally.
16144182|NCT01826370|Drug|Linagliptin|tablet
16144183|NCT01826331|Behavioral|Incentives for Participation|Participants will receive three smoking cessation programs
16144184|NCT01826331|Behavioral|Incentives for Cessation|Participants will have access to a smoking cessation program
16144185|NCT01826318|Behavioral|Stress coping|"Students in the intervention group received a 10 minute instruction to cope with stress. They were informed that an emergency situation is a stressful experience for health care workers and that perceived stress may interfere with their decision-making abilities and performance. Particularly, feeling overwhelmed by stress may cause cognitive impairment potentially leading to loss of concept how to deal with an emergency situation, which in turn further increases stress (vicious cycle). However, it is possible to overcome this situation by focusing on the basic conditions of the situation and the immediate actions that are needed. They were instructed that they should ask two task-focusing questions aloud (what is the patient's condition?, what immediate action is needed?) to overcome the negative consequences of feeling overwhelmed by stress."
16144186|NCT01826305|Procedure|Formal Rehabilitation Therapy|Patients that will be randomized to the formal rehabilitation therapy cohort will be prescribed formal therapy for twelve weeks with supervised exercises to regain knee strength and range of motion. Therapists will not be involved in the study design and therapists will not be informed that patients are participating in this study. The content, frequency, and duration of the rehabilitation program will be at the discretion of the treating therapist, consistent with usual practice.
16144187|NCT01826305|Procedure|Independent Exercise Cohort|The patients who will be in the independent exercises cohort will be registered on www.careforpatients.com, an online rehabilitation resource that provides computer aided rehabilitative exercises. Patients will follow a prepared 12-week protocol of exercises to perform post-operatively to gradually regain their knee strength, flexion, extension, abduction, and adduction.
16144188|NCT01826279|Dietary Supplement|Resveratrol|500mg 3 times daily for 1 month
16144189|NCT01826279|Other|Placebo|1 placebo tablet 3 times daily for 1 month
16144190|NCT01826266|Drug|PER977, Placebo|
16144191|NCT01826253|Drug|hydroxyethylstarch 130/0.4|Bolus of 100ml of HES 130/0.4 repeated until maximization of cardiac output
16144192|NCT01826240|Behavioral|MBCT+SPI|Safety Planning Intervention (SPI), a very brief intervention focused on identifying personalized coping strategies to manage acute suicidality, is combined with Mindfulness-Based Cognitive Therapy (MBCT), a group intervention comprised of mindfulness training and cognitive therapy techniques. Treatment lasts 9 weeks.
16144193|NCT01826227|Procedure|Positron Emission Tomography|
16144194|NCT01826227|Radiation|18F-Fluoro-2-deoxy-D-lucose|
16144195|NCT01826227|Procedure|Cytoreductive surgery|
16144196|NCT01826214|Drug|LDE225|LDE225 will be supplied as 200 mg capsules by Novartis. Patients will receive study treatment on an outpatient basis. LDE225 will be dispensed every two weeks for the first four weeks and at the start of every four weeks thereafter, as needed.
16144197|NCT01826201|Drug|MOL4239|10% MOL4239 ointment to one target lesion twice a day for 28.5 consecutive days
16144198|NCT01826201|Drug|Placebo|placebo ointment to the contralateral target lesion twice a day for 28.5 consecutive days
16144199|NCT01826188|Drug|THC 5mg/ml and CBS 50mg/ml|olive oil containing THC and CBD
16144200|NCT01826188|Drug|Placebo|olive oil without cannabis
16144201|NCT01826175|Drug|Ticagrelor|Subjects are randomized to receive a loading dose of ticagrelor or clopidogrel, and all subjects have Optical Coherence Tomography (OCT) imaging performed at the end of their stenting procedures.
16144202|NCT01826175|Drug|Clopidogrel|Subjects are randomized to receive a loading dose of ticagrelor or clopidogrel, and all subjects have Optical Coherence Tomography (OCT) imaging performed at the end of their stenting procedures.
16144203|NCT01826175|Device|Optical Coherence Tomography|Subjects are randomized to receive a loading dose of ticagrelor or clopidogrel, and all subjects have Optical Coherence Tomography (OCT) imaging performed at the end of their stenting procedures.
16144204|NCT01826162|Other|acetate or placebo infusion|
16144205|NCT01826149|Drug|Propofol 1.0mcg|Propofol dosage titration to achieve effect site concnetration at 1.0 mcg/ml using target controlled infusion.
16144206|NCT01826149|Drug|Propofol 2.0mcg|Propofol dosage titration to achieve effect site concnetration at 2.0 mcg/ml using target controlled infusion.
16144207|NCT01826149|Drug|Propofol 3.0mcg|Propofol dosage titration to achieve effect site concnetration at 3.0 mcg/ml using target controlled infusion
16144208|NCT01826136|Device|Acapella device|
16144209|NCT01826123|Device|Conventional laboratory testing (Central laboratory)|aPTT, INR, fibrinogen concentration, platelet count
16144210|NCT01826123|Device|POC testing|ROTEM: Clotting time (CT) in the EXTEM- and INTEM-test, Maximal clot firmness in the FIBTEM-test, Clot Lysis Index (CLI) multiplate: Area under the aggregation curve following stimulation with arachidonic acid (ASA) and Adenosine diphosphate (ADP)
16144211|NCT01826110|Drug|[11C]PIB|Approximately 15 mCI [11C]PIB IV x1
16144212|NCT01826097|Device|La-Z-Boy Massage Chair Vibration Effect on Bladder Cancer Cell Concentration|
16144213|NCT01826071|Other|Static Stretch|
16144214|NCT01826071|Other|Active Elongation|
16144215|NCT01826058|Radiation|Stereotactic body radiation therapy|
16144216|NCT01826045|Drug|Poly-gamma Glutamic Acid|
16144217|NCT01826045|Drug|Placebo|
16144218|NCT01826032|Device|CPAP|CPAP treatment every night plus standard care for OSA: lifestyle, and sleep hygiene counselling
16144219|NCT01826032|Other|Standard care for OSA|sleep higiene and dietary counseling
16144220|NCT01826019|Other|Intervention|In intervention communities, management plans will be developed by the NPHW for all enrolled participants. The NPHWs will educate participants about CVD, HT treatment, lifestyle modifications and initiate therapy according to the modified WHO CVD risk-management algorithm, including referral of high-risk patients to physicians and safety monitoring where appropriate. Participants in intervention communities will have support from family or friends (treatment supporters) and will receive educational materials and treatment reminders using text-messaging, email, and printed materials, as appropriate for the participant and the community setting. Evidence-based CV medications will be made available to the NPHWs and supervising physicians for participant treatment.
16144221|NCT01826019|Other|Usual Care|At initial screening, eligible participants will be provided with a brief information booklet/leaflet (customized to the community or region) regarding lifestyle modification and be advised to see their usual physician for care that is considered appropriate. No structured interventions will be employed.
16144222|NCT01826006|Device|Excimer laser|
16144223|NCT01826006|Device|Manual Thrombus Aspiration|
16144224|NCT01825993|Drug|L-BUPIVACAINE ; MORPHINE|
16144225|NCT01825993|Drug|MORPHINE|
16144226|NCT01825980|Drug|BZF961|There will be 2 parts to the study: Part 1: BZF monotherapy. Part 2: Cohort IIa: BZF961 monotherapy at 3 TBD doses; Cohort IIb: BZF961 in combination with ritonavir at TBD doses.
16144227|NCT01825980|Drug|Ritonavir|Ritonavir will be given as a boosting agent in Part 2, Cohort IIb in combination with BZF961
16144228|NCT01825980|Drug|Placebo|Placebo
16144229|NCT01825967|Other|C-reactive protein|measured C-reactive protein in all patients with acute diverticulitis
16144230|NCT01825954|Device|RINCE|The intervention uses the NeuroPoint device to deliver repeat applications of RINCE therapy stimulation. The sham uses the NeuroPoint device, but the RINCE therapy stimulation is not turned on.
16144231|NCT01825941|Drug|metoclopramide|10 milligrams, administered intravenously over 15 minutes
16144232|NCT01825941|Drug|diphenhydramine|50 milligrams, administered intravenously over 15 minutes
16144233|NCT01825941|Drug|placebo|
16144234|NCT01825928|Drug|Paliperidone|Paliperidone group,3mg/pill,3mg/day forced titration method,last 84 days
16144235|NCT01825928|Drug|placebo|placebo group,3mg/pill,3mg/day forced titration method,last 84 days
16144236|NCT01825915|Procedure|Laparoscopic Hysterectomy|
16144237|NCT01825915|Procedure|Laparoscopic Supracervical Hysterectomy|
16144238|NCT01825902|Drug|fluorine F 18 fluorothymidine|Undergo 18F-FLT PET
16144239|NCT01825902|Radiation|fludeoxyglucose F 18|Undergo 18F-FDG PET
16144240|NCT01825902|Procedure|positron emission tomography|Undergo 18F-FLT PET and 18F-FDG PET
16144241|NCT01825902|Procedure|diffusion-weighted magnetic resonance imaging|Undergo DW-MRI
16144242|NCT01825902|Other|laboratory biomarker analysis|Correlative studies
16144243|NCT01825889|Drug|Evacetrapib|
16144244|NCT01825876|Drug|Evacetrapib|Oral administration
16144245|NCT01825876|Drug|Warfarin|Oral administration
16144246|NCT01825863|Drug|Ropivacaine|
16144247|NCT01825863|Drug|Saline 9%|
16144248|NCT01825850|Drug|Gemigliptin|
16144249|NCT01825850|Drug|Irbesartan|
16144250|NCT01825837|Drug|BIA 2-093 1800 mg once daily [Group 1 (Part II)]|BIA 2-093 1800 mg taken orally in the evening, for 2 weeks
16144251|NCT01825837|Drug|BIA 2-093 900 mg once daily [Group 2 (Part II)]|BIA 2-093 900 mg taken orally in the evening, for 2 weeks
16144252|NCT01825837|Drug|BIA 2-093 300 mg once daily [Group 3 (Part II)]|BIA 2-093 300 mg taken orally in the evening, for 2 weeks.
16144253|NCT01825837|Drug|BIA 2-093 900 mg (Part I)|In Part I, patients received one 900 mg BIA 2-093 tablet once daily, taken orally in the evening, for 2 weeks.
16144287|NCT01825551|Drug|Granulocyte Colony Stimulating Factor|
16144288|NCT01825551|Drug|Placebo|
16144470|NCT01824186|Procedure|SILC|Underwent single-incision laparoscopic cholecystectomy
16144254|NCT01825824|Radiation|Stereotactic ablative radiotherapy|The HCC patients with size ≤5 cm and 3 cm apart from gastrointestinal tract will be included in this study. Total stereotactic ablative radiotherapy (SABR) doses will be 60 Gy in 3 fractionations. Patients receive 3 fractionations separated by >48 hours. At least 700 ml of normal liver (entire liver minus cumulative GTV) should not receive a total dose of > 17 Gy in three fractions. If volume of normal liver does not exceed 700 ml, at least 70% of normal liver should not receive a total dose of > 17 Gy. Dose of esophagus, stomach and intestine do not exceed 30 Gy.
16144255|NCT01825811|Biological|TissueGene-C (Low dose)|TissueGene-C at 1.0 x 10^6 cells mixed with fibrin-glue
16144256|NCT01825811|Biological|TissueGene-C (High dose)|TissueGene-C at 3.0 x 10^6 cells mixed with fibrin-glue
16144257|NCT01825798|Drug|Metformin|Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily.
16144258|NCT01825798|Drug|Placebo|The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.
16144259|NCT01825785|Drug|Romosozumab|Administered by subcutaneous injection
16144260|NCT01825785|Drug|Placebo|Administered by subcutaneous injection
16144261|NCT01825759|Drug|danshen dripping pill|
16144262|NCT01825746|Other|Implementation of the MOHR assessment in primary care workflow|The MOHR assessment includes (1) asking patients to complete the MOHR assessment on the web prior to encounters (available at www.MyOwnHealthReport.org it addresses10 distinct health behaviors and psychosocial issues including physical activity, diet, alcohol consumption, tobacco use, drug use, sleep, stress, depression and anxiety), (2) provision, via the tool, immediate patient feedback that includes identification of unhealthy issues, assessment of readiness to change, prioritization of issues to change, and preparation for goal-setting and action planning, (3) feedback to the primary care team on the patient status and priorities for change, (4) provision of counseling, goal setting, and referrals to local resources by clinicians during the subsequent office visit, and (5) follow-up with the clinicians and local resources as agreed upon by the patient and clinician.
16144263|NCT01825733|Drug|ramosetron|Ramosetron 0.3 mg was mixed to the PCA. Same dose of drug was administered 10 minutes before the end of surgery according to the allocated group.
16144264|NCT01825733|Drug|palonosetron|palonosetrno 0.075 mg was mixed to the PCA. Same dose of drug was administered 10 minutes before the end of surgery according to the allocated group.
16144265|NCT01825720|Drug|(Glucose-Insulin-Potassium)GIK group|infusion of 0.1 IU/kg/hr of insulin and mixture of 30% dextrose water with 80 mmol/l of potassium in the rate of 0.5 ml/kg/hr through out the surgery
16144266|NCT01825720|Drug|normal saline group|same rate of normal saline
16144267|NCT01825707|Drug|[14C]-YH4808 200 mg|[14C]-YH4808 200 mg (oral) on day1
16144268|NCT01825694|Behavioral|Trauma-focused Substance Abuse Intervention|An integrated treatment approach to reduce substance use and PTSD symptoms. The intervention program includes: 1) 1-2 individual sessions during which youth talk about the trauma, during the course of the intervention program; 2) 16 group sessions for youth; 3) 2 conjoint sessions with parents to improve communication and problem-solving skills; and 4) 2 parent-education group sessions.
16144269|NCT01825681|Behavioral|Positive Affect|Six-session skill-building program designed to raise levels of positive emotion when skills are practiced over the duration of the program.
16144270|NCT01825668|Other|Plant Sterols|
16144271|NCT01825668|Other|High cholesterol|
16144272|NCT01825668|Other|Placebo|
16144273|NCT01825655|Drug|Cetirizine|
16144274|NCT01825655|Drug|Placebo or sugar pill|
16144275|NCT01825642|Procedure|nerve-sparing radical prostatectomy|
16144276|NCT01825642|Procedure|seminal vesicle-sparing radical prostatectomy|
16144277|NCT01825629|Other|Multidisciplinary therapy|"Physical Therapy: Cervical traction, Cranium fore flexion 15 °, Open-close mouth dental contactless (10 mm), Opening movement with a small resistor (one finger on chin), Flexion of the head, without actually lifting, resisting in the front, Occipital extension, Cranium fore flexion 15 °, Cervical traction.
~Myofascial Therapy: Induction suboccipital, compression - decompression of the temporomandibular joint, horizontal induction of the temporomandibular joint, deep fascia induction in the temporal region, deep induction of the masseter fascia, deep induction of the external pterygoid, and induction of intraoral pterygoid.
~Deontology therapy: the patient are going to port a deprogramming occlusal splint every night, an average of 8 hours per day, for 15 weeks."
16144278|NCT01825629|Other|Placebo|
16144279|NCT01825616|Dietary Supplement|Vitamin D2 mushroom powder|Subjects will be given Portobello mushroom powder with or without vitamin D mixed in soymilk powder in six plastic containers (one for each week of the study). Subjects will ingest one level teaspoon of the product each day (with or without 4,000 IU vitamin D2) and consume during breakfast in one of the following ways: mixed in water, juice, yogurt, or milk.
16144280|NCT01825616|Other|Placebo|Mushroom powder without vitamin D2
16144281|NCT01825603|Drug|ADH-1|Given IV
16144282|NCT01825603|Drug|Cisplatin|Given IV
16144283|NCT01825603|Drug|Gemcitabine Hydrochloride|Given IV
16144284|NCT01825603|Other|Laboratory Biomarker Analysis|Correlative studies
16144285|NCT01825590|Other|Dialysate and serum sodium concentration aligned|
16144286|NCT01825577|Drug|Transdermal Methylphenidate|2 Weeks of once daily 10mg Transdermal Methylphenidate followed by 2 weeks of once daily 15mg Transdermal Methylphenidate. Patch will be worn for approximately 7-10hrs each day.
16144289|NCT01825525|Device|Exposure to ScopeGuide|The 2 minute protocol exposure to the electromagnetic field of the ScopeGuide device.
16144290|NCT01825512|Drug|Deferiprone|Deferiprone 80 mg/mL oral solution
16144291|NCT01825512|Drug|Deferasirox|Deferasirox is used at the following dosage strengths: 125 mg, 250 mg and 500 mg
16144292|NCT01825499|Other|Registry|
16144293|NCT01825486|Behavioral|accidental falls|
16144294|NCT01825473|Drug|Erythromycin|
16144295|NCT01825473|Device|Multi-channel intra-luminal impedance (MII) pH monitoring|
16144296|NCT01825473|Drug|Placebo (D5W)|
16144297|NCT01825460|Other|Manual Therapy Protocol|The manual therapy protocol consists in the application of the following techniques: stretching diaphragm, Inhibition for phrenic center, Neuromuscular technique, technique jones and balance technique functional.
16144298|NCT01825460|Other|Two manual techniques|The two manual techniques applied to control group are: inhibition for phrenic center and neuromuscular technique.
16144299|NCT01825447|Drug|Placebo|0.9% sodium chloride for injection x 1 dose administered intravenously (IV) push over 4 min.
16144300|NCT01825447|Drug|Oxycodone + Naltrexone|Oxycodone hydrochloride (HCl) 20 mg IV and naltrexone HCl 2.4 mg IV administered simultaneously x 1 dose IV push over 4 min.
16144301|NCT01825447|Drug|Oxycodone|Oxycodone HCl 20 mg for injection x 1 dose IV push over 4 min.
16144302|NCT01825434|Dietary Supplement|yogurt containing: polydextrose L. acidophilus NCFM® B. lactis HN019|NCFM Group
16144303|NCT01825421|Other|Intervention is to stop antibiotics at 24h .|Stoppage of antibiotics at 24h in the intervention arm, randomization based on neutrophil CD64 values.
16144304|NCT01825408|Drug|Doxycycline|Subjects with CRSwNP who are not allergic to doxycycline will receive Doxycycline 100mg BID for either 3 or 6 weeks duration.
16144305|NCT01825408|Drug|Azithromycin|Subjects with CRS without Nasal Polyposis (CRSwNP)who are not allergic to azithromycin will be given Azithromycin 250mg daily for either 3 or 6 weeks duration.
16144306|NCT01825408|Drug|Augmentin|If a subject in any of the study arms is allergic to the medication he/she is supposed to receive, he/she will be given Augmentin 875mg BID for either 3 or 6 weeks duration
16144307|NCT01825395|Drug|3, 4-Diaminopyridine|
16144308|NCT01825382|Device|iBGStar meter|Subjects will receive iBGStar meter and iPhone to use as meter during the study.
16144309|NCT01825369|Drug|IV L-carnitine|See arm description
16144310|NCT01825356|Procedure|Dorsal Cheilectomy without Amniotic Membrane Tissue Implantation|
16144311|NCT01825356|Procedure|Dorsal Cheilectomy with Amniotic Membrane Tissue Implantation|
16144312|NCT01825330|Device|TMS and cognitive stimulation|Synchronized TMS and cognitive stimulation to 6 brain areas.
16144313|NCT01825330|Device|sham|
16144314|NCT01825317|Device|NeuroAD|synchronized TMS+COGNITIVE TRAINING
16144315|NCT01825317|Device|Sham device|Sham TMS+cog, has the same sound and appearance as the real device, delivers no energy.
16144316|NCT01825304|Device|titrated setting peep|titrated setting peep according to esophageal pressure in experimental group; setting peep on the patient's PaO2 and FiO2 in control group.
16144317|NCT01825291|Procedure|CPAP treatment|
16144318|NCT01825278|Device|ExSpiron Respiratory Volume Monitor (RVM, ExSpiron™, Respiratory Motion, Inc.; Waltham, MA|Monitoring sensors will be applied to patient's right chest and the monitoring device will collect breathing parameters such as breathing rate and volumes before, during and after the procedure until patient is ready to leave the recovery room. At the beginning and at the end of the study investigator will perform a one-time measurement of patient's respiratory parameters using a standard handheld spirometer. This is a non-invasive device that is commonly used in clinical care not related to research.
16144319|NCT01825252|Behavioral|Social Network Intervention|Approximately 20% of people are trained to have discussions endorsing less risky behaviors with members of their social network.
16144320|NCT01825252|Behavioral|Counsel, Test, and Treat|People receive standard-of-care HIV/STD counseling, testing, and treatment
16144321|NCT01825239|Other|Collection of measurements during LV pacing during electrophysiology study|During the electrophysiology study, measurements will be obtained while pacing from different left ventricular regions in context to scar as determined by SPECT-CT testing.
16144322|NCT01825226|Other|Enhanced-Homestead Food Production Program|Participation in an enhanced-homestead food production program including home gardening and nutrition and health behavior change communication
16144323|NCT01825213|Device|Multispectral CT of the liver|Analysis of the background liver and liver lesions will be performed on Multi Spectral CT images and compared to histology.
16144324|NCT01825200|Biological|Flublok|A Biologics Licensing Application (BLA) for Flublok was approved by the FDA for influenza immunization of adults 18-49 years of age. Flublok is produced using recombinant technology under serum-free conditions.
16144325|NCT01825200|Biological|Afluria|Afluria is approved for use in persons 5 years of age and older and is produced by inactivation and disruption of live influenza virus grown in embryonated chicken eggs.
16144326|NCT01825187|Device|ULTRAPRO Mesh|Patients who are randomized to this group will received ULTRAPRO Mesh for their hernia repair
16144327|NCT01825187|Device|3DMAX|Patients who are randomized to this group will receive 3DMAX mesh for their hernia repair
16144328|NCT01825187|Other|Evaluation|To evaluate the ease of use and time it takes residents to place and perform the surgery using these two different meshes.
16144329|NCT01825174|Behavioral|Ball games program|twice a week different ball games 90min
16144330|NCT01825174|Behavioral|Nutrition counseling|9 units of 90min each of nutrition counseling
16144331|NCT01825148|Other|radiolabeled Exendin|
16144332|NCT01825135|Device|Neuromuscular electrical stimulation|
16144333|NCT01825135|Device|sham stimulation|sham stimulation will be applied to the quadriceps
16144334|NCT01825122|Drug|Nadolol|
16144335|NCT01825122|Drug|Placebo|
16144336|NCT01825109|Biological|Rotavirus Vaccine & Breastfeeding|Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus vaccine with no intervention in normal breastfeeding practices before and after receiving vaccine.
16144337|NCT01825109|Biological|Rotavirus Vaccine & Breastfeeding|Administration of Rotarix at 6 and 10 weeks co-administered with oral polio virus. Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
16144338|NCT01825109|Biological|Rotavirus Vaccine & Breastfeeding|Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus, with no intervention in normal breastfeeding practices before and after receiving vaccine.
16144339|NCT01825109|Biological|Rotavirus Vaccine & Breastfeeding|Administration of Rotarix at 14 and 18 weeks co-administered with oral polio virus. Breastfeeding will not be permitted 45 minutes prior to vaccine administration and 45 minutes after each vaccine administration.
16144340|NCT01825083|Drug|Ketamine|Ketamine group receives 0.5mg/kg followed by an infusion of 1.5mcg/kg/min.
16144341|NCT01825083|Drug|Placebo|0.9 % normal saline group receives same volume as the ketamine dose
16144342|NCT01825070|Dietary Supplement|Montmorency cherry concentrate|Tart Montmorency cherry juice concentrate
16144343|NCT01825057|Behavioral|See One|A 1-day workshop conducted by a member of the Motivational Interviewing Network of Trainers (MINT), according to MINT recommendations, to build providers' skills needed to use MI with patients who misuse substances.
16144344|NCT01825057|Behavioral|Do One|A 1-day workshop conducted by a member of the Motivational Interviewing Network of Trainers (MINT), according to MINT recommendations, to build providers' skills needed to use MI with patients who misuse substances. Following the workshop training, providers conduct two motivational interviews bedside with patients under the supervision of one of the MI-trained CL clinicians, who subsequently give them performance feedback and coaching. Providers receive one more supervised practice case mid-trial. In addition, they can request additional supervision at any point during the trial.
16144345|NCT01825057|Behavioral|Order One|"A 1-day workshop conducted by a member of the Motivational Interviewing Network of Trainers (MINT), according to MINT recommendations, to build providers' skills needed to use MI with patients who misuse substances. Following the workshop, providers have the option to conduct MI with patients themselves or to order a MI for delivery by one of the MI-trained CL clinicians."
16144346|NCT01825044|Drug|NeuroSTAT 5 mg/kg/day|Intravenous bolus of NeuroSTAT (Ciclosporin) 2.5 mg/kg bodyweight followed by 5 days of 5 mg/kg bodyweight/day continuous infusion
16144347|NCT01825044|Drug|NeuroSTAT 10 mg/kg/day|Intravenous bolus of NeuroSTAT (Ciclosporin) 2.5 mg/kg bodyweight followed by 5 days of 10 mg/kg bodyweight/day continuous infusion
16144348|NCT01825031|Drug|Raltegravir|400mg twice daily for the first 12 weeks only in addition to 3 standard ARVs
16144349|NCT01825031|Drug|Fluconazole|100mg once daily for 12 weeks
16144350|NCT01825031|Drug|Azithromycin|500mg once daily for 5 days
16144351|NCT01825031|Drug|Albendazole|a single dose 400mg
16144352|NCT01825031|Drug|Isoniazid|300mg taken immediately in combination with cotrimoxazole
16144353|NCT01825031|Dietary Supplement|Ready to Use Supplementary Food|2x92g packets daily of high energy, low protein lipid-based paste for 12 weeks
16144354|NCT01825018|Behavioral|Social Network Leader Endorsement|Leaders of the 16 intervention condition networks will attend a 7-session intervention, with the first 5 sessions held weekly and the last 2 at biweekly intervals. Networks will include persons with differing care histories including PLH never in care, those who dropped out of care, and those who attend medical appointments irregularly or are inconsistent in adherence. Network leaders will be trained to tailor communications to each friend's care circumstances. Issues of current injecting drug users (IDUs) may differ from non-IDUs. Therefore, intervention content will be tailored based on formative phase findings, and groups for IDU network leaders will be held separately.
16144355|NCT01825018|Behavioral|HIV Counseling|At the baseline session, participants in the comparison condition will receive counseling about the benefits and availability of HIV care and the importance of treatment adherence.
16144356|NCT01824992|Drug|Yallaferon®|
16144357|NCT01824979|Device|CPAP mask ( Pilairo)|
16144358|NCT01824979|Procedure|Other CPAP mask|
16144359|NCT01824940|Behavioral|Standard care|"Standard Care:
~Exclusive breastfeeding promotion for all infants, birth to 6 months
~Strengthened PMTCT (prevention of mother to child transmission of HIV) services
~Strengthened Village Health Worker system"
16144360|NCT01824940|Other|WASH|"WASH:
~Standard care interventions
~Provide household ventilated pit latrine, water treatment solution, and monthly liquid soap, two hand-washing facilities and protected infant play space
~Provide interpersonal communication interventions promoting feces disposal in a latrine, HWWS (hand washing with soap), drinking water treatment, hygienic weaning food preparation, and preventing babies from putting dirt and animal feces in their mouths."
16144361|NCT01824940|Dietary Supplement|Infant and young child feeding|"IYCF:
~Standard care interventions
~Provide 20 g/d Nutributter from 6-18 months
~Provide interpersonal communication interventions promoting optimal use of locally available foods for complementary feeding after 6 months, continued breastfeeding and feeding during illness."
16144362|NCT01824940|Other|WASH and Nutrition|"WASH AND IYCF interventions
~Standard care interventions
~All WASH interventions
~All IYCF interventions"
16144363|NCT01824927|Procedure|First eye (FE)|Phacoemulsification cataract extraction surgery
16144364|NCT01824927|Procedure|Second eye (SE)|Phacoemulsification cataract extraction surgery
16144365|NCT01824927|Drug|Steroids eye drops|Use steroids eye drops to decrease the pain.
16144366|NCT01824914|Device|McGrath Videolaryngoscope|A kind of portable videolaryngoscopes, produced by Aircraft Medical. It has been used for difficult airway.
16144367|NCT01824901|Drug|docetaxel|Given IV
16144368|NCT01824901|Drug|AZD4547|Given PO
16144369|NCT01824888|Drug|JUC solution|1.5 ml JUC solution rubbing on hands for 30 seconds, repeated twice
16144370|NCT01824888|Drug|propan-2-ol|1.5 ml propan-2-ol rubbing on hands for 30 seconds, repeated twice
16144371|NCT01824875|Drug|temozolomide|Given PO
16144372|NCT01824875|Drug|capecitabine|Given PO
16144373|NCT01824875|Other|laboratory biomarker analysis|Correlative studies
16144374|NCT01824849|Procedure|Total arytenoidectomy|Endoscopic total arytenoidectomy was performed on patients with bilateral vocal fold paralysis
16144375|NCT01824849|Procedure|Partial arytenoidectomy|Endoscopic partial arytenoidectomy was performed on patients with bilateral vocal fold paralysis
16144376|NCT01824836|Drug|anastrozole|Given PO
16144377|NCT01824836|Other|questionnaire administration|Ancillary studies
16144378|NCT01824836|Other|laboratory biomarker analysis|Correlative studies
16144379|NCT01824836|Other|pharmacogenomic studies|Correlative studies
16144380|NCT01824823|Drug|afatinib|Given PO
16144382|NCT01824810|Procedure|Intramuscular Stimulation|"Intramuscular Stimulation is the insertion of fine, flexible needles into shortened muscle tissue. No substance is injected. In shortened or supersensitive muscles, stimulation of stretch receptors in the muscle causes a lengthening response in the affected tissue. This reflex response is felt by the patient as a cramping sensation which releases as the muscle returns to a normal length. Needles may be inserted and removed immediately or inserted and left in the tissue for several minutes. Practitioners may also use the approach of twirling the needles to enhance the grasping response in the muscle."
16144383|NCT01824810|Procedure|myoActivation|In myoActivation treatments, a fine needle is used to administer a micro-injection (less than .2 mL) of saline (0.9%) targeted to muscle, fascia, connective tissue, and scar tissue. The needle is inserted into shortened muscle tissue to elicit a reflex response that lengthens the tissue and promotes a healing response. One session includes between 10 and 80 needle insertions, and is a combination of deep and shallow needling techniques. Additionally, the practitioner treats superficial fascia and scar tissue by using multiple shallow needle insertions to a scarred area and/or areas of abnormal elevation and depression in the skin.
16144384|NCT01824810|Procedure|Neural Prolotherapy|Participants in the neural prolotherapy group will receive micro-injections of a dextrose or mannitol solution directly under the skin using a very fine needle. This treatment targets the superficial cutaneous nerves. It is suggested that these injections quickly reduce cutaneous nerve edema, allowing these nerves to freely cross the fascia to reach the skin. Treatments may include up to 200 micro-injections with a fine needle. Injections follow major nerve routes associated with neck and upper back pain.
16144385|NCT01824810|Procedure|Sham Needling Control|The sham needling control group will receive up to 5 needle insertions in areas unrelated directly to whiplash pain. No injection will be given though participants in this group will not be aware of the presence or absence of a substance injection. Sham treatments will take anywhere from 15 to 60 minutes, to preserve blindness.
16144386|NCT01824771|Other|Plasma lactate were measured|Three different doses (20 ml/kg/h, 35 ml/kg/h and 45 ml/kg/h) of CVVH were applied to critically ill patients who experiencing CVVH. Each dose of CVVH was sequentially gave to each patient and lasted for 30 minutes separately
16144387|NCT01824758|Drug|Lidocaine|Group L lidocaine (0.5 mg/kg), (rocuronium) (0.05mg/kg).
16144388|NCT01824758|Drug|Esmolol|Group E: esmolol (1 mg/kg), (rocuronium) (0.05mg/kg)
16144389|NCT01824758|Drug|rocuronium|0.05 mg/kg rocuronium
16144390|NCT01824758|Drug|Placebo|Group C: Placebo (NaCl 0.9%, 5 ml), (rocuronium) (0.05mg/kg)
16144391|NCT01824745|Other|educational intervention|Receive the SCP-BCS template booklet
16144392|NCT01824745|Other|counseling intervention|Receive counseling sessions with a patient navigator
16144393|NCT01824745|Procedure|standard follow-up care|Receive standard follow-up care
16144394|NCT01824745|Procedure|quality-of-life assessment|Ancillary studies
16144395|NCT01824745|Other|questionnaire administration|Ancillary studies
16144396|NCT01824706|Procedure|craniectomy|craniectomy
16144397|NCT01824693|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic HCT
16144398|NCT01824693|Drug|Busulfan|Given IV
16144399|NCT01824693|Drug|Cyclophosphamide|Given IV
16144400|NCT01824693|Drug|Fludarabine Phosphate|Given IV
16144401|NCT01824693|Other|Laboratory Biomarker Analysis|Correlative studies
16144402|NCT01824693|Drug|Melphalan|Given IV
16144403|NCT01824693|Drug|Mycophenolate Mofetil|Given IV or PO
16144404|NCT01824693|Other|Pharmacological Study|Correlative studies
16144405|NCT01824693|Drug|Tacrolimus|Given IV or PO
16144406|NCT01824680|Behavioral|Physical activity|"There is two sequences, one before and one after the physical activity program. Each sequence contains one rest session and one exercise session"
16144407|NCT01824667|Dietary Supplement|B-GOS|
16144408|NCT01824667|Dietary Supplement|Maltodextrin|
16144409|NCT01824654|Other|Validation of the new rigid registration software|Several new features of this beta software such as an improved correction system by automatic capture of DSA, an automated 3D/3D rigid registration, recognition of the origin of internal iliac arteries will be implemented. This new beta version will be tested in 20 cases of EVAR/FEVAR at CHUM Research center and Dalhousie University-QEII Health Sciences Centre.
16144410|NCT01824654|Other|Validation of the new elastic registration software|This software integrating deformation of vasculature induced by insertion of endovascular devices will be tested in real time in 20 patients requiring SG procedures at CHUM Research center and Dalhousie University-QEII Health Sciences Centre and compared to the prior cohort having EVAR/FEVAR procedures with rigid registration.
16144411|NCT01824641|Device|Eliminate aspiration catheter|Eliminate aspiration catheter
16144412|NCT01824641|Procedure|Conventional primary angioplasty|Primary angioplasty without thrombus aspiration
16144413|NCT01824615|Drug|Sunitinib|37.5mg everyday from D1-D28
16144414|NCT01824602|Drug|Eslicarbazepine acetate 1800 mg|Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets.
16144415|NCT01824602|Drug|Eslicarbazepine acetate 1200 mg|Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets.
16144416|NCT01824602|Drug|Eslicarbazepine acetate 600 mg|Eslicarbazepine acetate to be taken orally, was available as 600 mg tablets.
16144417|NCT01824602|Drug|Placebo|Placebo sugar pills
16144418|NCT01824589|Device|-7 cm H2O ITPR|Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -7 cmH2O between periods of positive pressure ventilations.
16144419|NCT01824589|Device|-12cm H2O ITPR|Single use disposable non-invasive device that is connected to a vacuum source and a means to deliver a positive pressure breath and generates negative3 pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure of -12 cmH2O between periods of positive pressure ventilations.
16144420|NCT01824576|Device|ITPR|Single use noninvasive device that is connected to a vacuum source and a means to deliver a positive pressure breath. The device generates negative pressure during the expiratory phase, thus creating subatmospheric intrathoracic pressure between the periods of positive pressure ventilations.
16144421|NCT01824563|Other|Observational study|
16144422|NCT01824550|Other|home-based exercise training condition|Home based endurance exercise training
16144423|NCT01824537|Biological|HPV vaccine, Gardasil 9|Once recruited, both individuals in a couple will be randomized independently to Gardasil 9 or placebo (Avaxim).
16144424|NCT01824537|Biological|Hepatitis A vaccine|Provided by Sanofi Pasteur.
16144425|NCT01824524|Drug|Hydromorphone|Participants will be administered a single dose of Osmotic Release Oral System (OROS) hydromorphone tablet of 8 milligram (mg) orally on Day 1 under fasting conditions.
16144426|NCT01824511|Behavioral|Smokers cease smoking|Smokers are paid to be abstinent for four weeks, and stop-smoking medications may not be used.
16144427|NCT01824498|Other|Low Fat diet|Low fat diet = 20% fat
16144428|NCT01824498|Other|Low Fat high n3 diet|Low Fat high n3 diet = 20% fat + 3% n3
16144429|NCT01824498|Other|High Fat Diet|High Fat Diet = 40% fat
16144430|NCT01824485|Drug|viscosupplementation 1+1+1|intra-articular injection with 1 ampoule per week for 3 weeks
16144431|NCT01824485|Drug|viscosupplementation 3 at once|single intra-articular injection with 3 ampoules
16144432|NCT01824472|Device|CPAP|Treatment for sleep apnea
16144433|NCT01824472|Behavioral|CBT|Treatment for insomnia
16144434|NCT01824472|Device|sham CPAP|Placebo for sleep apnea
16144435|NCT01824472|Behavioral|CC|Placebo (sham) for insomnia
16144436|NCT01824459|Drug|S-1|S-1：40~60mg bid，d1~14 q3W
16144437|NCT01824459|Drug|Oxaliplatin|oxaliplatin：130mg/m2，iv drip for 2h，d1,q3W
16144438|NCT01824459|Drug|Cisplatin|cisplatin：60mg/m2，iv drip ，d1,q3W
16144439|NCT01824446|Drug|Radiolabeled SPD602 (FBS0701, SSP-004184)|A single oral dose of 3g of radio-labelled SSP-004184 on Day 1
16144440|NCT01824433|Drug|venlafaxine|venlafaxine 75-225mg qd
16144441|NCT01824433|Drug|fluoxetine|fluoxetine 20-60mg qd
16144442|NCT01824420|Drug|Detrusitol 4mg QD and Oxybutynin ER 5mg QD|Study group
16144443|NCT01824420|Drug|Detrusitol 4mg QD|Control group
16144444|NCT01824407|Device|Electrohydraulic-generated shock wave|
16144445|NCT01824407|Device|Sham device plus standard of care|
16144446|NCT01824394|Device|nMARQ Navigation Catheters|
16144447|NCT01824394|Device|NaviStar ThermoCool Catheters|
16144448|NCT01824381|Procedure|Place amniotic membrane in large wounds|"After the process of obtaining the amniotic membrane, it must be processed, frozen and thawed.
~The wound is washed with saline and, if necessary it will be debrided. We will take microbiological control cultures. Then apply the amniotic membrane fragments sufficient to cover the wound by contacting the basal membrane of the amniotic membrane with granulation tissue.
~We will place a new membrane weekly to a maximum of 6 times."
16144449|NCT01824381|Procedure|Obtaining and Cryopreservation of amniotic membrane|
16144450|NCT01824381|Drug|amniotic membrane|
16144451|NCT01824368|Procedure|Extracorporeal Photopheresis Procedure (FEC)|"The FEC will be held in the Cellex (Therakos), and authorized device in routine use in our unit for performing FEC in the treatment of graft-versus-host and cutaneous T-cell lymphoma. After performing a blood count, will connect the patient to Cellex through a central or peripheral.
~1500 mL typically be processed peripheral blood mononuclear fraction obtained by apheresis process. Then be added Uvadex (8-metoxipsolareno, 0.017 mL / mL) to the mononuclear fraction bag and proceed to photoactivation with UVA radiation.
~Finally the photoactivated product is again infuse the patient. It will monitor the final blood count to assess hemoglobin and platelets. The entire procedure is performed in a single step and closed mode, with Cellex."
16144452|NCT01824355|Device|Ninja 3 PLUS Investigational BG Monitoring System|Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method.
16144453|NCT01824342|Biological|Denosumab|Administered by subcutaneous injection
16144454|NCT01824329|Procedure|Prostate capsule sparing cystectomy|Removes the adenoma and prostatic urethra along with the urinary bladder, but leaves in situ the prostatic capsule and subsequently the surrounding neurovascular bundle.
16144455|NCT01824329|Procedure|Nerve sparing cystectomy|Attempts to spare the cavernosal nerves that travel immediately adjacent to the lateral prostate and are routinely divided during a standard RCP.
16144456|NCT01824303|Drug|LiRIS 400 mg|LiRIS 400 mg contains lidocaine which is gradually released into the bladder over 14 days.
16144457|NCT01824303|Other|LiRIS Placebo|LiRIS Placebo contains lactose, inactive substance.
16144458|NCT01824290|Drug|Tadalafil|Administered orally by tablet form for heavy and middle weight participants. Administered orally by suspension for light weight participants.
16144459|NCT01824290|Drug|Placebo|Administered orally by tablet for heavy and middle weight participants. Administered orally by suspension for light weight participants.
16144460|NCT01824290|Drug|ERA as specific PAH treatment|All participants were taking endothelin receptor antagonist (ERA) (such as bosentan, ambrisentan and macitentan).
16144461|NCT01824277|Other|Structured Pre-operative Diabetes Optimization|Patients will receive structured pre-operative diabetes optimization while they wait for surgery. Patients will be referred to the Youville Diabetes Center where they will undergo preoperative optimization of their diabetes management. This will include in-depth diabetes education and instruction pertaining to lifestyle modification (blood glucose monitoring, nutrition, and physical activity) to improve glycemic control. Pharmacologic therapy will be reviewed by the Youville Diabetes Center certified diabetes nurse educators.
16144462|NCT01824264|Drug|LIK066|Experimental treatment doses
16144463|NCT01824264|Drug|Sitagliptin|Active comparator treatment dose
16144464|NCT01824264|Drug|Placebo|Placebo comparator dose
16144465|NCT01824251|Drug|NPB-01|
16144466|NCT01824238|Drug|Anacetrapib|
16144467|NCT01824238|Drug|Placebo for anacetrapib|
16144468|NCT01824225|Drug|Aflibercept|
16144469|NCT01824199|Drug|Omeprazole|Patients with LA Grade B-D erosive esophagitis identified at the time of endoscopy will be prospectively recruited. Patients will undergo whole blood testing for CYP2C19 genotype and will be started on omeprazole 40 mg once daily in the morning 30 minutes before breakfast. The Mayo Dysphasia Questionnaire -30 day (MDQ-30day) will be used during the study. At the end of 8 weeks, patients will undergo dual probe pH/impedance testing on therapy and a clinically indicated endoscopy to rule out Barrett's esophagus and assess healing. CYP2C19 genotyping will be performed in the Mayo laboratory.
16144471|NCT01824186|Procedure|LC|Underwent conventional 4-port laparoscopic cholecystectomy
16144472|NCT01824173|Other|Increase in the levels of plasma amino acids|Aminosyn 15%; 160 mg/kg FFM/h for 4 hours
16144473|NCT01824173|Other|Aerobic exercise|Moderate intensity for 45 minutes
16144474|NCT01824160|Device|Repair of RV-PA Conduit Disruption|Repair of RV-PA Conduit Disruption
16144475|NCT01824134|Other|Klean & Klear The Dandy Day Corp|
16144476|NCT01824134|Other|The Skin Gel Herbal Answers, Inc|
16144477|NCT01824121|Biological|stem cell therapy|Bone marrow will be collected from the iliac crest under local anesthesia. Mesenchymal Stem Cells (MSCs) will be isolated and cultivated in vitro. Patients will be catheterized and the MSCs will then be administered by intra-arterial route via the internal carotid artery and the vertebral artery that is largest in caliber, injecting small boluses manually through a microcatheter.
16144478|NCT01824108|Procedure|Lumbar discectomy|All the patients were in prone positions on the operation table and received general anesthesia. A midline incision was made and paravertebral muscles were dissected unilaterally. Disc excision and nerve root decompression were initially accomplished through a unilateral transflaval approach. Then the wound was closed with a suction drain.
16144479|NCT01824108|Procedure|Lumbar discectomy combined with Wallis interspinous dynamic stability system|The Wallis interspinous implant is placed after a lumbar discectomy. Interspinal ligaments of operated segment were removed and supraspinal ligament were retained. And then the proper size of Wallis implant was mounted underneath the supraspinous ligament and secured to the spine with the attached Dacron bands,above and below the corresponding spinous processes.
16144480|NCT01824095|Dietary Supplement|Dietary supplement|
16144481|NCT01824082|Drug|Perineural infusion [continuous peripheral nerve block(s)]|Electronic, programmable, portable infusion pumps will be used to administer perineural study solution at fixed rates for over 6 days. Subjects will receive a total of 1,100 mL of study fluid from either one (upper extremity) or two (lower extremity) pump and external reservoir combinations. The continuous basal infusion rate will be determined by catheter location: femoral 2.5 mL/h; popliteal-sciatic 5 mL/h; and infraclavicular 7.5 mL/h (37.5 mg/h for both upper and lower extremity subjects). No patient-controlled bolus dose will be included. Subjects will have the option of returning 4-16 weeks later for a second infusion of the alternate treatment solution.
16144482|NCT01824069|Other|Intramuscular injection of a suspension of adult mesenchymal stem cells derived|Intramuscular injection of a suspension of adult mesenchymal stem cells derived from adipose tissue at doses of 1 million per kilo of weight. Only one dosis by patients
16144483|NCT01824056|Drug|18F-FDG|"During this study, subjects will receive a single i.v. administration of approximately 10 mCi 18F-FP-(+)-DTBZ immediately prior to imaging.
~The proposed dose for this study is based on our phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG."
16144484|NCT01824043|Drug|intravitreal ranibizumab injections|Patients will be treated monthly: intravitreal ranibizumab (0.5 mg) will be administered in an open-label fashion, using 3 monthly injections (at day 0, day 30 and day 60) followed by an additional post treatment visit, a month after the last injection, for posterior reports
16144485|NCT01824030|Device|FFR guided PCI|FFR to assess coronary artery stenosis severity and indication to perform and eventually optimize percutaneous coronary intervention
16144486|NCT01824030|Device|OCT guided PCI|OCT to assess coronary artery stenosis severity and indication to perform and eventually optimize percutaneous coronary intervention
16144487|NCT01824017|Other|Blood Draw|
16144488|NCT01824004|Drug|S-1|
16144489|NCT01823991|Drug|VitaBlue™|"Self administration of nutritional supplement COGNUTRIN for 3 months.
~The supplement to be used will be a combination of the following: (1) VitaBlue (40% polyphenolics, 12.5% anthocyanins from blueberries (BB) and (2) n-3 fatty acids - Lovaza."
16144490|NCT01823991|Other|Placebo|"Self administration of placebo for 3 months.
~Investigators use a placebo to make sure that it really is the study medicine that is making a difference in the participant's condition. It does not have anything in it that would normally help or harm most people."
16144491|NCT01823991|Drug|Lovaza®|"Self administration of nutritional supplement COGNUTRIN for 3 months.
~The supplement to be used will be a combination of the following: (1) VitaBlue (40% polyphenolics, 12.5% anthocyanins from blueberries (BB) and (2) n-3 fatty acids - Lovaza."
16144492|NCT01823978|Biological|BPX-201 vaccine plus AP1903|The trial design consists of 3 cohorts of 6 patients each, receiving escalating doses of BPX-201 of 10 million (M), 20M and 40M cells, respectively. Dose escalation will occur according to a 3+3 design. Patients will receive administration of BPX-201 every other week for 6 cycles (1 cycle equals 2 weeks). Approximately 1.6 mL of BPX-201 will be administered as 8 intradermal injections (200μL each) at each treatment visit. On the day following each vaccination, a single 40 mg dose of the activating agent, AP1903, will be administered via intravenous (IV) infusion over 2 hours.
16144493|NCT01823965|Drug|ranibizumab|
16144494|NCT01823939|Drug|iOWH032|"Part A: Participants will be randomized at a 3:1 ratio to receive treatment with iOWH032 or placebo. A randomisation code will be generated. Each participant will be assigned the next participant number available and thereby will be assigned randomly. Active treatment will consist of an oral tablet containing 300 mg of iOWH032. The placebo will consist of identical looking tablets.
~Part B: There will be no randomization during this trial. All eligible patients will receive 300 mg of iOWH032."
16144495|NCT01823926|Other|Noninvasive ventilation|Bilevel positive pressure (BiPAP Synchrony, Respironics®, Murrysville, Pennsylvania, USA) was applied through face mask (Comfort Full 2, Respironics®, Murrysville, Pennsylvania, USA) attached with straps and pressure adjusted were 12 cmH2O of inspiratory pressure and 5 cmH2O of expiratory pressure at the beginning of the procedure (França et al., 2006).
16144496|NCT01823926|Device|Jet nebulizer|"Both nebulizers were charged with 2.5 mg of salbutamol and 0.25 mg of ipratropium bromide and 3 mL of saline solution was added to complete 3 Ml. JN (Mist yMax, Air Life, Yorba Linda, USA) was positioned in the circuit using a T piece, particle size generation in a 5 µm range (according to the manufacturer information) and flow oxygen tritated at 8 L/min."
16144533|NCT01823575|Device|Double-J stent|Placement of double-J stent as a conventional treatment to be compared with a new experimental treatment - deployment of silicone-covered metallic stent
16144497|NCT01823926|Device|The vibrating mesh nebulizer (VMN)|Both nebulizers were charged with 2.5 mg of salbutamol and 0.25 mg of ipratropium bromide and 3 mL of saline solution was added to complete 3 Ml. VMN (Aeroneb Solo, Galway, Ireland) was positioned in the mask using an elbow (Elbow Kit, Respironics®, Murrysville, Pennsylvania, USA), particle size generation in a 1 µm and connected to electrical energy.
16144498|NCT01823913|Drug|Test formulation|A single oral dose of a combination tablet of amlodipine orotate 10mg and valsartan 160mg
16144499|NCT01823913|Drug|Reference formulation|A single oral dose of a combination tablet of amlodipine besylate 10mg and valsartan 160mg
16144500|NCT01823900|Drug|Test formulation|Single administration of a combination tablet of Rosuvastatin 20mg and Olmesartan 40mg
16144501|NCT01823900|Drug|Reference formulation|Co-administration of Rosuvastatin 20mg tablet and Olmesartan 40mg tablet
16144502|NCT01823887|Device|Vagus Nerve Stimulation (VNS)|Electrical Stimulation of the Vagus Nerve
16144503|NCT01823874|Procedure|virtual reality distraction|Pain distraction will be measured with both the HMD virtual reality method and the ID virtual reality method.
16144504|NCT01823861|Behavioral|Mobile phone-based intervention|Automated voice message to support post-abortion contraception use every two weeks for total of three months. Direct follow up phone call by family planning counsellor depending on response to voice message.
16144505|NCT01823848|Drug|Sodium phosphate enema|Rectally administered medication to treat constipation
16144506|NCT01823848|Drug|Normal saline enema|Rectally administered medication to treat constipation
16144507|NCT01823848|Drug|Mineral oil enema|Mineral oil enema administered to treat constipation. 66ml per rectum
16144508|NCT01823835|Drug|GDC-0810|GDC-0810 administered orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, GDC-0810 drug supply exhausted, or study termination (up to 3 years).
16144509|NCT01823835|Drug|LHRH Agonist|LHRH agonist administered once monthly until disease progression, unacceptable toxicity, withdrawal of consent, GDC-0810 drug supply exhausted, or study termination (up to 3 years). Choice of LHRH agonist will be an institutional choice approved for use in breast cancer.
16144510|NCT01823835|Drug|Palbociclib|Palbociclib administered orally once daily until disease progression, unacceptable toxicity, withdrawal of consent, GDC-0810 drug supply exhausted, or study termination (up to 3 years).
16144511|NCT01823822|Dietary Supplement|Oral protein supplement (Tested product)|Test product: oral protein supplement, sweetened flavoured dairy product, type fresh cheese rich in milk protein (15 g/150 grams). Dosage is 2 pots daily, at least 5 days/week for 4 consecutive weeks.
16144512|NCT01823822|Dietary Supplement|Iso-caloric supplement (Control product)|Control product: sweetened flavoured fresh cheese, with low milk protein content (3 g/150 grams). Dosage is 2 pots daily, at least 5 days/week for 4 consecutive weeks.
16144513|NCT01823809|Device|adenosine stress Cardiac Magnetic Resonance Imaging|
16144514|NCT01823796|Other|Fibromyalgia women group|Assessment of this group at baseline in order to be compared with a control group.
16144515|NCT01823796|Other|Healthy women|These women are assessed in order to be compared with fibromyalgia women group.
16144516|NCT01823783|Other|Muscle biopsy|Muscle biopsy
16144517|NCT01823770|Drug|Rotigotine|Subjects randomized to rotigotine will start treatment with a rotigotine dose of 1mg/24h for 1 week. The dose can be increased weekly until either the optimal or the maximal dose of 3mg/24h has been reached. Subjects will maintain the optimal/maximal dose during the 2-week Maintenance Period. Following the Maintenance Period, subjects will be de-escalated from their optimal dose by decreasing the dose by 1mg/24h every other day until complete withdrawal (Taper period).
16144518|NCT01823770|Drug|Placebo patchs|Subject randomized on the placebo group will be treated with placebo patchs, following the same modalities and study periods that the rotigotine arm
16144519|NCT01823757|Other|Pharmaceutical care|pharmacists provide pharmaceutical care to the intervention group, comparing to ordinary care in control group
16144520|NCT01823744|Dietary Supplement|micronutrient supplementation|
16144521|NCT01823718|Biological|Injection of allogenic CTL EBV specific|
16144522|NCT01823705|Device|Exilis Implantable Gastric Electrical Stimulation (GES)|
16144523|NCT01823692|Other|ultrasonography|after manipulation and reduction were performed by single emergency medicine specialist under Bier block regional anesthesia or procedural sedation-analgesia, The ultrasonography was performed by the single emergency department physician in a long axis both in a anterioposterior and lateral views in determining whether the distal and proximal distal to a fracture was in a straight line (less than 3 mm difference) or not?
16144524|NCT01823679|Drug|Capecitabine|Given orally
16144525|NCT01823653|Device|Liposonix System (Model 2)|Treatment of Subcutaneous Adipose Tissue in the thighs using High Intensity Focused Ultrasound
16144526|NCT01823640|Other|placebo|
16144527|NCT01823640|Other|Human Rhinovirus strain 16 (HRV-16)|100 TCID50 dosis of HRV-16 will be inoculated on day 7 and / or day 0
16144528|NCT01823627|Procedure|Spirometry with reversibility test|Spirometry with reversibility test and CATest questionaire. following will be measured FEV1 L/s FVC L/s FEV1/FVC ration
16144529|NCT01823601|Behavioral|Behavioral Management Program|Consists in 10 Sessions of 120 minutes of duration, to train diaphragmatic breathing; autogenic training of muscle relaxation; progressive self-focus meditation and cognitive-behavioral training.
16144530|NCT01823601|Behavioral|Seminars in Health|Volunteers that participate in 10 weekly sessions of seminars in health
16144531|NCT01823588|Behavioral|Nurse-led reminder through email.|"Both groups will receive an educational program and usual care. The educational program will consist of 1-hour sessions, during which the NCM emphasize the importance of blood pressure control and correct measurement, give advice for a correct blood pressure self-measurement; report non-pharmacological strategies for a healthy lifestyle, and instruction on how to fill the daily self-assessment form.
~Educational program and usual cardiovascular prevention. The educational program will consist of 1-hour sessions, during which the NCM emphasize the importance of blood pressure control and correct measurement, give advice for a correct blood pressure self-measurement; report non-pharmacological strategies for a healthy lifestyle, and instruction on how to fill the daily self-assessment form."
16144532|NCT01823575|Device|Silicone-covered metallic stent|deployment of silicone-covered metallic stent for malignant ureteral obstruction as a new therapy as compared with placement of double-J stent as a conventional therapy
16144540|NCT01823549|Other|questionnaire administration|Ancillary studies
16144541|NCT01823536|Biological|Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine|Subjects received at day 1 a single dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.
16144542|NCT01823523|Drug|Cefazolin, Cephalexin, Clindamycin|
16144543|NCT01823510|Drug|Ticagrelor + Aspirin|Single loading doses of Ticagrelor (180 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (ticagrelor 90 mg twice daily + ASA 81 mg once daily).
16144544|NCT01823510|Drug|Clopidogrel + Aspirin|Single loading doses of Clopidogrel (600 mg) and ASA (325 mg), followed by daily dosing for 5-7 days (clopidogrel 75 mg + ASA 81 mg once daily).
16144545|NCT01823497|Drug|Morphine|Morphine will be used to control pain post-surgery.
16144546|NCT01823484|Device|AN 69 ST hemofilter|
16144547|NCT01823484|Device|AN 69 hemofilter|
16144548|NCT01823471|Other|The use of I-scan in the detection of polyps in HNPCC|Prior the colonoscopy patients will be randomized to white light first or i-scan first. After the caecum is reached patients will be first examined according to the randomization. Each colonic segment will be investigated in a back to back fashion, during the second pass the other modality will be used.
16144549|NCT01823458|Behavioral|Lottery Insurance|
16144550|NCT01823458|Behavioral|Standard Lottery|
16144551|NCT01823445|Other|Xylitol disk|
16144552|NCT01823406|Procedure|Euglycemic clamp (normal blood sugar clamp) for 4 hours|
16144553|NCT01823406|Procedure|hyperglycemic clamp (elevated blood sugar to 300) for 4 hours|
16144556|NCT01823380|Procedure|Blood test|Blood test
16144557|NCT01823367|Behavioral|Diabetes Prevention Program (DPP)|Diabetes Prevention Program (DPP): This is an evidence-based curriculum that has shown that it is possible to prevent or delay Type 2 Diabetes (T2D) in individuals if they keep a healthy weight, eat a nutritious diet, and stay physically active.
16144558|NCT01823354|Other|Polysomnography|Polysomnography involves the collection of the electroencephalogram, electromyogram of, and electro-oculogram to differentiate the various stages of sleep. Determination of different stages and cycles of sleep will be manually by reading the EEG, EMG, EOG over periods of 30 seconds after the standardized criteria of AASM (American Academy of Sleep Medicine). Registration will take place between sleep and 23h 7am.
16144559|NCT01823354|Other|Clinical Scales|Index of Restless Legs Syndrome Severity, Index of insomnia Severity, Beck's Inventory of Depression, Anxiety Inventory: State-Trait, form Y.
16144560|NCT01823354|Other|Assessment of executive functions|"Verbal fluencies Test GREFEX (Assessment of the spontaneous flexibility), Stroop Test GREFEX (Inhibition of the automatic response Capacity ), Trail Making Test GREFEX (Assessment of flexibility reactive), Wisconsin Card Sorting Test(Overall assessment of executive functions), Working memory TAP, Flexibility TAP, Go/no go TAP, Phasic alertness (Assessment of speed information processing)."
16144561|NCT01823354|Other|Medical consultation|open questions
16144562|NCT01823341|Device|Pump suspension algorithm|The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia.
16144563|NCT01823328|Drug|Ketamine|Subjects will receive ketamine for sedation prior to rapid sequence intubation.
16144564|NCT01823328|Drug|Etomidate|Subjects will receive etomidate for sedation prior to rapid sequence intubation.
16144565|NCT01823315|Drug|MTX 1|MTX 0.4mg/(kg·d) intramuscularly (IM) on days 1-5
16144566|NCT01823315|Drug|MTX 2|MTX 100mg/m(2), IV, on day1 (after Act-d); MTX 200mg/m(2), IVgtt, on day1 (after MTX, 500ml NS, >4h)
16144567|NCT01823315|Biological|Act-d|Act-d 0.6mg/m(2), IV, on day1,2
16144568|NCT01823302|Dietary Supplement|nutrition counseling plus oral milk-based nutritional supplement|Study group subjects were instructed to consume at least 2 servings (230 mL per serving) of an oral milk-based nutritional supplement daily, in addition to their regular diet, for a total of 120 (±3) days.
16144569|NCT01823302|Other|nutritional counseling|nutritional counseling
16144570|NCT01823289|Drug|Itraconazole|Itraconazole 200 milligram (mg) intravenous injection will be given twice daily for first 2 days, 200 mg once daily for the subsequent 12 days, then sequential itraconazole oral solution 200 mg twice daily will be given for 2 to 4 weeks.
16144571|NCT01823276|Other|Tyrosine-Containing Bar|
16144572|NCT01823276|Other|Placebo Bar|
16144573|NCT01823263|Behavioral|Portion Size Task|Participants are given a computer program that gives them the opportunity to choose the portions of a variety of food items that they would ideally like to consume
16144574|NCT01823263|Procedure|Blood sample|In the morning following partial sleep deprivation or normal sleep, a blood sample will be taken to assess the level of metabolism-linked and neurodegenerative-linked molecules, as well as to assay blood serum and plasma for the presence of hormones involved in hunger such as ghrelin
16144575|NCT01823263|Procedure|Interference task|30-minute interference task
16144576|NCT01823263|Behavioral|Memory tasks|Participants will be allowed to learn a procedural memory task before going to bed. Participants will be retested in the morning to assess their change in performance. Other memory tests will also be given to assess the working memory performance in the morning following the intervention.
16144577|NCT01823263|Behavioral|Intake task|After a normal night of sleep or partial sleep deprivation, participants are presented with an ad libitum meal choice and can select the amount to ingest during a limited time window. Amount and selection will be recorded
16144578|NCT01823263|Behavioral|Working memory function task|Participants will be evaluated on their working memory performance in the morning following either nighttime intervention (NS or PSD)
16144774|NCT01821937|Drug|Faldaprevir(low dose)|faldaprevir(low dose) will be taken by 1 day single use and 10 days multiple use. the subjects will be assigned to low dose treatment in random order
16144579|NCT01823250|Behavioral|Family Therapy based on Structural Family Therapy|Once per week family therapy based on Structural Family Therapy. Sees to improve parenting practices, communication, and problem solving skills. It also seeks to increase the attachment/bond between parents and adolescents.
16144580|NCT01823250|Behavioral|Group Therapy|Group Therapy is provided once per week and is designed to share information on HIV and STI risk and protection. There are typically 8-10 adolescents in a group.
16144581|NCT01823250|Behavioral|Psychoeducational Sessions|Psycho-educational sessions are used to provide didactic in formation to parents alone, adolescents alone, or both together. Content may focus on parenting, drug use risks, depression, HIV/STI risk or other major issues that adolescents and families confront. There are also modules that focus on culture-related stressors and processes that can be provided to families for whom this is a prominent issue.
16144582|NCT01823250|Behavioral|Individual Adolescent Therapy Sessions|Individual sessions with the adolescent focus on Motivational Interviewing, coaching for family sessions, and monitoring of unhealthy behaviors.
16144583|NCT01823237|Device|Transcranial Magnetic Stimulation|
16144584|NCT01823224|Drug|"2 capsules Oral Tylenol 2000 mg and IV salt water"|"The participants randomized to receive the '2 capsules Oral Acetaminophen 500 mg and IV salt water repeated 4 hours after that dose to equal 2000mg. A pre-op pain score was obtained and pain scores every 15 min x 1 hour then per recovery routine and they did a 24 hour home diary to record pain scores for 24 hours post surgery. Their opioid morphine equivalent was recorded intraoperatively, recovery and at home. This was compared to the other group receiving IV acetaminophen.and the pain scores and morphine equivalents were collected the same as in the comparative group. Each group received a placebo version oral or iv accordingly."
16144585|NCT01823224|Drug|"IV tylenol 1000mg and 2 oral capsule sugar pills"|"IV acetaminophen 1000mg and 2 oral capsule sugar pills were given to participants that were randomized to receive the IV acetaminophen. The same collection of pain scores and morphine equivalents was completed the same as the other group."
16144586|NCT01823198|Biological|Aldesleukin|Given SC
16144587|NCT01823198|Biological|Allogeneic CD56-positive CD3-negative Natural Killer Cells|Given IV
16144588|NCT01823198|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic PBSC transplant
16144589|NCT01823198|Drug|Busulfan|Given IV
16144590|NCT01823198|Drug|Fludarabine Phosphate|Given IV
16144591|NCT01823198|Other|Laboratory Biomarker Analysis|Correlative studies
16144592|NCT01823198|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo allogeneic PBSC transplant
16144593|NCT01823198|Other|Pharmacological Study|Correlative studies
16144594|NCT01823185|Drug|clopidogrel|Genotyping will be carried out using Spartan genotyping System on all intervention group and those patients who do not carry the CYP2C19 allele 2 or 3 will be given clopidogrel (75 mg per day) while all patients who carry the CYP2C19 allele 2 or 3 will be prescribed Ticagrelor (90 mg twice daily) or prasugrel ( 10mg once daily or 5mg once daily if the patient older than 75 years or a body weight < 60kg) according to local protocol.
16144595|NCT01823185|Drug|Ticagrelor or prasugrel|ticagrelor (90 mg twice daily) or prasugrel ( 10mg once daily or 5mg once daily if the patient older than 75 years or a body weight < 60kg) according to local protocol.
16144596|NCT01823172|Procedure|Methylene blue dye injection of sentinel lymph node|Single arm study. Methylene blue will be injected into the 1st SLN and traced via the efferent lymphatic to the 2nd echelon lymph node.
16144597|NCT01823159|Drug|retigabine|Single oral administration of a 400 mg tablet.
16144598|NCT01823159|Drug|placebo|Single oral administration of a tablet
16144599|NCT01823146|Drug|Oxytocin spray|single dose of 24 IU oxytocin, self-administered intranasally (IN)
16144600|NCT01823146|Drug|Placebo spray|single dose of 24 IU placebo (same solution as oxytocin spray but without oxytocin), self-administered intranasally (IN)
16144601|NCT01823133|Drug|gemigliptin only|gemigliptin 50mg qd on day 1~7
16144602|NCT01823133|Drug|rosuvastatin only|rosuvastatin 20mg qd on day 1~7
16144603|NCT01823133|Drug|gemigliptin and rosuvastatin|gemigliptin 50mg, rosuvastatin 20mg qd on day 1~7
16144604|NCT01823120|Other|Supportive and interactive text messages|
16144605|NCT01823107|Device|Meso BioMatrix Device|
16144606|NCT01823081|Drug|Intravitreal injection of bevacizumab (Avastin)|
16144607|NCT01823081|Drug|Intravitreal injection of fasudil and bevacizumab (Avastin)|intravitreal injections of bevacizumab and fasudil are performed at two different sites (superior temporal and inferior temporal quadrants respectively)
16144608|NCT01823068|Drug|Vandetanib|Patients will begin on once daily vandetanib at 300 mg with one cycle of 4 weeks.
16144609|NCT01823055|Procedure|Transvaginal suture capturing mesh device|The Uphold™ LITE vaginal support system is an intra-vaginal approach to apical and anterior vaginal wall prolapse repair that utilizes a suture capturing device to place the mesh. After primary dissection the suturing device is used to pull the mesh through the sacrospinous ligament, medial to the ischial spine. An anterior colporraphy was allowed following the Uphold™ LITE procedure at the discretion of the surgeon if deemed necessary.
16144610|NCT01823042|Drug|azathioprine+enteral nutrition|
16144611|NCT01823042|Drug|Azathioprine|
16144612|NCT01823029|Drug|erythropoietin|
16144613|NCT01823029|Drug|enteral nutrition.|
16144614|NCT01823029|Drug|injection of iron|
16144615|NCT01823016|Drug|Placebo|Placebo tablet, taken once daily
16144616|NCT01823016|Drug|JNJ-38518168|JNJ-38518168, 30 mg tablet, taken once daily
16144617|NCT01823003|Radiation|34 Gy in a single fraction|34 Gy in a single fraction in case of Distance to chest wall > 1 cm, tumour size < 2 cm and distance to the main bronchus > 2 cm. STEREOTACTIC ABLATIVE RADIOTHERAPY (SABR) will be administered with volumetric modulated arcs, with photon beam energy of 6-10 MV. The number of arcs and their ballistic is left undefined in order to allow for optimization of the dose distribution. Bolus is not allowed.
16144618|NCT01823003|Radiation|54Gy 18Gy/fr. x 3 fractions|54Gy administered in 3 fractions of 18Gy in case of distance to chest wall > 1 cm, tumour size between 2 and 5 cm and distance to the main bronchus > 2 cm. STEREOTACTIC ABLATIVE RADIOTHERAPY (SABR)will be administered with volumetric modulated arcs, with photon beam energy of 6-10 MV. The number of arcs and their ballistic is left undefined in order to allow for optimization of the dose distribution. Bolus is not allowed.
16144775|NCT01821911|Biological|Zagreb2-1-1|Injection on day 0、7、21
16144619|NCT01823003|Radiation|60Gy (12 x 5 fr.s)|50Gy administered in 5 fractions of 12 Gy for Peripheral Nodes in case of distance to chest wall < 1 cm, tumour size < 5 cm and distance to main bronchus > 2 cm. STEREOTACTIC ABLATIVE RADIOTHERAPY (SABR) will be administered with volumetric modulated arcs, with photon beam energy of 6-10 MV. The number of arcs and their ballistic is left undefined in order to allow for optimization of the dose distribution. Bolus is not allowed.
16144620|NCT01823003|Radiation|60Gy (7.5Gy x 8fr.)|60 Gy administered in 8 fractions of 7.5 Gy for mediastinal nodes in case of tumour size < 5 cm and distance to the main bronchus < 2 cm. STEREOTACTIC ABLATIVE RADIOTHERAPY (SABR)will be administered with volumetric modulated arcs, with photon beam energy of 6-10 MV. The number of arcs and their ballistic is left undefined in order to allow for optimization of the dose distribution. Bolus is not allowed.
16144621|NCT01822977|Drug|omeprazole|
16144622|NCT01822964|Device|targeted brain cooling (33°C) by RhinoChill device|targeted brain cooling by Rhinochill device to 33°C tympanic temperature during TAVI procedure. After valve implantation, slow rewarming until 35.5°C
16144623|NCT01822964|Device|Placebo - current clinical practice, no cooling|
16144624|NCT01822951|Drug|Cerebrolysin|"Intravenous medication is given in three treatment courses (TC). Each treatment course lasts for two weeks and consists of 10 infusions (5 infusions weekly). The first treatment course (TC 1) will be in Week 1 and 2, second treatment course (TC 2) will be repeated during Week 9 and 10 and third treatment course (TC 3) during Week 19 and 20.
~Placebo for donepezil:1 tablet per day from TC 1 Day 1 on and 2 tablets per day from Visit 3 - Visit 5, p.o."
16144625|NCT01822951|Drug|Donepezil|"5-10 mg donepezil: 1x5 mg donepezil as 1 tablet per day from TC 1 Day 1 on and 2x5 mg donepezil as 2 tablets from Visit 3- Visit 5, p.o.
~Intravenous medication is given in three treatment courses (TC). Each treatment course lasts for two weeks and consists of 10 infusions (5 infusions weekly). The first treatment course (TC 1) will be in Week 1 and 2, second treatment course (TC 2) will be repeated during Week 9 and 10 and third treatment course (TC 3) during Week 19 and 20."
16144626|NCT01822938|Other|incentive program for physical activity|
16144627|NCT01822925|Drug|DA-9801 300mg|300 mg of DA-9801 in tablet form, 100 mg to be taken 3 times daily for 12 weeks.
16144628|NCT01822925|Drug|DA-9801 600mg|600 mg of DA-9801 in tablet form, 200 mg to be taken 3 times daily for 12 weeks.
16144629|NCT01822925|Drug|DA-9801 900mg|900 mg of DA-9801 in tablet form, to be taken 300 mg to be taken 3 times daily for 12 weeks.
16144630|NCT01822925|Drug|Placebo|Placebo, in tablet form, to be taken 3 times daily for 12 weeks. The placebo is the same formulation as DA-9801 except that it does not contain the active pharmaceutical ingredient.
16144631|NCT01822912|Other|Heart Failure Disease Management Program|Subjects will be assessed 3 times a week while in SNF.
16144632|NCT01822912|Other|Heart Failure Usual Care|Subjects will receive standard of care.
16144633|NCT01822899|Drug|Umeclidinium bromide/Vilanterol|Dry white powder of UMEC 62.5 mcg per blister and VI 25 mcg per blister as NDPI with 30 doses (2 strips with 30 blisters per strip).
16144634|NCT01822899|Drug|Placebo ACCUHALER/DISKUS|Dry white powder of matching placebo as multidose dry powder inhaler containing a foil strip with 60 blisters (1 strip with 60 blisters per strip).
16144635|NCT01822899|Drug|Fluticasone propionate/Salmeterol|Dry white powder of fluticasone propionate 500 mcg per blister 50 mcg salmeterol per blister as multidose dry powder inhaler containing a foil strip with 60 blisters (1 strip with 60 blisters per strip).
16144636|NCT01822899|Drug|Placebo NDPI|Dry white powder of matching placebo as NDPI with 30 doses (2 strips with 30 blisters per strip).
16144637|NCT01822886|Drug|Romidepsin + Gemcitabine|Romidepsin 12 mg/m2 day 1,8, 15 + Gemcitabine 800 mg/m2 day 1, 15 for 6 cycles by 28 days followed by Romidepsin 14 mg/m2 day 1, 15 to PD
16144638|NCT01822860|Drug|Chlorthalidone 12.5 mg|
16144639|NCT01822860|Drug|Hydrochlorothiazide 25 mg|
16144640|NCT01822860|Drug|Placebo|
16144641|NCT01822821|Drug|IV Acetaminophen|Patients will receive up to four doses of IV Acetaminophen (1000mg)every six hours after surgery along with standard PCA (patient controlled) opioids.
16144642|NCT01822821|Drug|Placebo|Patients will receive up to four doses placebo every six hours after surgery along with standard PCA (patient controlled) opioids.
16144643|NCT01822808|Drug|Hydralazine|Hydralazine and placebo will be supplied as 25mg identical tablets and given at a dosage of 75mg/day up to week 4, thereafter 150mg/day up to week 24.
16144644|NCT01822808|Drug|Isosorbide Dinitrate|Isosorbide dinitrate and placebo will be supplied as 10mg identical tablets and given at a dosage of 30mg/day up to week 4, thereafter 60mg/day up to week 24.
16144645|NCT01822795|Procedure|Lung volume reduction coïl treatment|
16144646|NCT01822795|Other|Regular medical treatment|
16144647|NCT01822782|Biological|Bacteriological analysis of vaginal sample|Bacteriological analysis of vaginal sample
16144648|NCT01822769|Other|Cardiopulmonary rehabilitation|See Arm Description
16144649|NCT01822769|Other|Standard of care|See Arm Description
16144650|NCT01822756|Drug|ruxolitinib|
16144651|NCT01822756|Drug|gemcitabine|Other names: Gemzar®
16144652|NCT01822756|Drug|nab-paclitaxel|Other names: Abraxane®
16144653|NCT01822756|Drug|filgrastim|Prophylactic GCSF support was filgrastim and was given in Cycle 1 on Days 2 to 5, 9 to 12, and 16 to 19, unless chemotherapy was held for toxicity, then prophylactic GCSF support was also held.
16144654|NCT01822743|Procedure|Osteopathic manipulative treatment|Osteopathic compression of pterygopalatine node
16144655|NCT01822743|Procedure|sham comparator|
16144656|NCT01822730|Drug|paliperidone|Paliperidone group,6mg/pill,6mg-12mg/day non-forced titration method,last 2-4weeks
16144657|NCT01822730|Drug|Risperidone|Risperidone group,1mg/pill,2mg-6mg/day non-forced titration method,last 2-4weeks
16144658|NCT01822717|Behavioral|Nonvisual foot inspection|Teaching use of nonvisual senses (tactile and olfactory) to empower people with diabetes and visual impairment to perform a systematic self-examination of their own feet
16144659|NCT01822717|Behavioral|Usual Care|Standard instructions for foot care for people with visual impairment include advice to have a sighted family member or friend check the person's feet regularly
16144660|NCT01822704|Device|Low intensity whole body vibration|
16144661|NCT01822704|Device|High intensity whole body vibration|
16144662|NCT01822704|Behavioral|Leg exercises|
16144776|NCT01821911|Biological|Essen|Injection on day 0、3、7、14、28
16144663|NCT01822691|Drug|INCB024360|INCB024360 is an inhibitor of the enzyme indoleamine 2,3-dioxygenase (IDO) that is proposed for development for the treatment of malignant diseases. Participants were to receive the study drug in 28 day (4 week) cycles of treatment.
16144664|NCT01822678|Drug|Eslicarbazepine Acetate|Eslicarbazepine Acetate, starting with 800 mg per day and up-titrated in 800 mg steps until 2400 mg (maximum dose) according to clinical response.
16144665|NCT01822678|Drug|Eslicarbazepine Acetate|Eslicarbazepine Acetate, starting with 600 mg per day and up-titrated in 600 mg steps until 1800 mg (maximum dose) according to clinical response.
16144666|NCT01822678|Drug|Placebo|Placebo
16144667|NCT01822665|Drug|Ibuprofen|Liquid gelation capsules or tablets of 400 mg strength
16144668|NCT01822665|Drug|Paracetamol|Paracetamol fast dissolving tablets of 500 mg strength
16144669|NCT01822665|Other|Placebo|Placebo tablets
16144670|NCT01822652|Genetic|iC9-GD2 T Cells - frozen|"Subjects will receive the iC9-GD2 T cells through an IV over 5 to 10 minutes.
~Subjects will receive one of the following dose levels (cells/m2):
~Dose Level 1 = 1 x 10^7
~Dose Level 2 = 1 x 10^8
~Dose Level 3 = 2 x 10^8
~Six weeks after the infusion, patients will have a disease re-evaluation. If the disease has not gotten worse AND they have not had a severe side effect caused by the infusion of the iC9-GD2 T cells, the subject may be eligible to receive up to 2 additional doses of T cells. Each dose will be at the same dose level as the first infusion, if available, and separated by at least 6 weeks."
16144671|NCT01822652|Genetic|iC9-GD2 T Cells - fresh|"For subjects who will receive a fresh T cell product:
~Dose Level 1 = 1 x 10^8
~Dose Level 2 = 1.5 x 10^8
~Dose Level 3 = 2 x 10^8
~Six weeks after the infusion, patients will have a disease re-evaluation. If the disease has not gotten worse AND they have not had a severe side effect caused by the infusion of the iC9-GD2 T cells, the subject may be eligible to receive up to 2 additional doses of T cells. Each dose will be at the same dose level as the first infusion, if available, and separated by at least 6 weeks."
16144672|NCT01822652|Drug|Cytoxan|Cyclophosphamide (500 mg/m2/day x 2 days, for patients <12 kg = 16.7 mg/kg/day x 2 days)
16144673|NCT01822652|Drug|Fludara|Fludarabine (30 mg/m2/day x 3 days, for patients <12 kg = 1 mg/kg/day x 3 days)
16144674|NCT01822652|Drug|Keytruda|Pembrolizumab (2 mg/kg on Day -1 and on Day 21).
16144675|NCT01822652|Genetic|iC9-GD2 T cells|"For subjects who will receive a fresh T cell product:
~Dose Level 1 = 1.5 x 10^8
~Dose Level 2 = 2 x 10^8
~Six weeks after the infusion, patients will have a disease re-evaluation. If the disease has not gotten worse AND they have not had a severe side effect caused by the infusion of the iC9-GD2 T cells, the subject may be eligible to receive up to 2 additional doses of T cells. Each dose will be at the same dose level as the first infusion, if available, and separated by at least 6 weeks."
16144676|NCT01822639|Drug|GSK2944404 FDC|Uncoated, round, yellow white bilayer fixed dose combination tablet containing 5 mg amlodipine and 20 mg enalapril for single dose oral administration in each period.
16144677|NCT01822639|Drug|Amlodipine 5 mg|Emerald-shaped white 5 mg amlodipine table for single dose oral co-administration with enalapril maleate tablet in each period.
16144678|NCT01822639|Drug|Enalapril Maleate 20 mg|Peach triangle shaped 20 mg enalapril maleate tablet for single dose oral co-administration with amlodipine in each period.
16144679|NCT01822626|Behavioral|motivational counseling|A family pediatrician-lead counselling was offered to children assigned to the intervention group. The counselling program consisted of 5 motivational interviews based on Stages of Change Theory. Child and family always had to leave the meeting having agreed two objectives, one concerning food and one physical activity improvements, clearly defined and achievable. During each subsequent interview was assessed the degree of achievement of the objectives of the previous meeting. Based on the assessment the objective could be reinforced or redefined. After each change the objectives were recorded.
16144680|NCT01822613|Drug|LJM716|LJM716 (10-40 mg/kg) will be given as a once weekly infusion beginning on cycle 1 day 1. The doses of LJM716 will be increased as dose escalation proceeds until a maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) is established.
16144681|NCT01822613|Drug|BYL719|BYL719 (200-400 mg) will be administered orally on a once daily schedule starting cycle 1 day 1. The doses of BYL719 will be increased as dose escalation proceeds until a maximum tolerated dose (MTD) and/or recommended phase II dose (RP2D) is established.
16144682|NCT01822613|Drug|Paclitaxel|In the Phase II portion of the study Paclitaxel is one of the 3 physician's choice drug which allows single-agent paclitaxel to be used per manufacturer's label.
16144683|NCT01822613|Drug|Docetaxel|In the Phase II portion of the study Docetaxel is one of the 3 physician's choice drug which allows single-agent docetaxel to be used per manufacturer's label.
16144684|NCT01822613|Drug|Irinotecan|In the Phase II portion of the study Irinotecan is one of the 3 physician's choice drug which allows single-agent irinotecan to be used per manufacturer's label
16144685|NCT01822600|Drug|Human albumin|Each patient in the intervention group received Human Albumin 20%® (ZLB Behring, Marburg, Germany), immediately. The dosage of albumin infusion was 10 g q8h for 1 day in patients with albumin levels ranging from 25 g/L to 29 g/L or 2 days in those with albumin levels < 25 g/L.
16144686|NCT01822600|Drug|Omeprazole|"After endoscopic hemostasis, each enrolled patient received an 80 mg loading dose of intravenous omeprazole (Losec®, AstraZeneca, Sweden) immediately. Patients then received a 3-day continuous omeprazole infusion in dosage of 80 mg per day.
~After omeprazole infusion, oral esomeprazole (Nexium®, AstraZeneca, Sweden) 40 mg per day was given in the normal albumin group and the intervention group until the end of follow-up.
~After omeprazole infusion, oral omeprazole (Losec®) 20 mg per day was given in the cohort control group until the end of follow-up."
16144687|NCT01822587|Drug|Propranolol, 40 mg|
16144688|NCT01822587|Drug|Propranolol, 80 mg|
16144689|NCT01822587|Drug|Placebo|
16144690|NCT01822574|Procedure|Cutting Guide Technique|The guide is clamped onto the patella and tightened so that it remains stable. The guide has a slot that allows insertion of a standard sagittal saw blade, and this slot guides the blade as it is advanced across the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
16144730|NCT01822314|Drug|Paclitaxel|Paclitaxel at the dosage of 90 mg/m2 diluted in 250 mL of water for injection (WFI) over 1 hour given week 1, 2 and 3 followed by 1 week rest and will be repeated for 4 cycles followed by AC or EC (adriamycin or epirubicin and cyclophosphamide) on day 1 every 3 weeks for 4 cycles or FEC (fluorouracil, epirubicin, and cyclophosphamide) on day 1 every three weeks for 4 cycles
16144691|NCT01822574|Procedure|Haptic Feedback Technique|It consists of a free hand cut (no guide used) with a standard sagittal saw that is oriented based on osteo-cartilaginous landmarks and haptic palpation of the patella by the surgeon. The resection thickness/obliquity can be altered based on haptic feedback (use of the sense of touch) of the patella. The thickness is then measured in the center of the patella to ensure that the resection goal is achieved. Additional resection may be performed as needed.
16144692|NCT01822574|Procedure|Four Quadrant Technique|Resection is performed in a free handed fashion, but after resection, the thickness of the patella is measured separately in all four quadrants (superolateral, superomedial, inferomedial, and inferolateral). Additional resection is performed as needed based on the quadrant measurements and the measurements are repeated after each resection until satisfactory resection thickness and symmetry are obtained.
16144693|NCT01822561|Drug|Eplerenone 50mg|All patients will receive the same dose of eplerenone.
16144694|NCT01822548|Drug|Vildagliptin|100 mg daily
16144695|NCT01822548|Drug|Glibenclamide|2.5 mg (total daily), progressively increased up to a maximum dose of 5 mg x 2/ day.
16144696|NCT01822548|Drug|Metformin|concomitant therapy with metformin is present in each arm (MAX dose: 2500 mg/die)
16144697|NCT01822535|Drug|Midodrine hydrochloride|Midodrine hydrochloride is an approved medication used to treat low blood pressure. We are using a standard dose of 10 mg (tablet) only one time to determine if the effects of this drug improve the ability to maintain body core temperature in a cool environment (off-label use). A physician will administer the drug once before the cool thermal challenge in subjects with tetraplegia only(Visit 2)
16144698|NCT01822522|Drug|Cabozantinib S-malate|Given PO
16144699|NCT01822522|Other|Laboratory Biomarker Analysis|Correlative studies
16144700|NCT01822522|Other|Pharmacological Study|Correlative studies
16144701|NCT01822509|Biological|Ipilimumab|Given IV
16144702|NCT01822509|Other|Laboratory Biomarker Analysis|Correlative studies
16144703|NCT01822509|Biological|Nivolumab|Given IV
16144704|NCT01822496|Radiation|Radiation Therapy|30 once-daily 2 Gy fractions over 6 weeks totaling 60 Gy of intensity-modulated radiation therapy (IMRT) or 3-dimensional conformal radiation therapy (3D-CRT).
16144705|NCT01822496|Drug|Carboplatin|"Concurrent: AUC=2, IV, days 1, 8, 14, 22, 29, and 36 of radiation therapy. For patients receiving either erlotinib or crizotinib, carboplatin will begin 2 weeks after erlotinib or crizotinib, as applicable.
~Consolidation: 4-6 weeks after completion of RT, AUC=6, IV, days 1 and 22."
16144706|NCT01822496|Drug|Cisplatin|50 mg/m2, IV (intravenous), on days 1 and 8 of two 4-week cycles concurrent with radiation therapy. For patients receiving either erlotinib or crizotinib, cisplatin will begin 2 weeks after the completion of erlotinib or crizotinib, as applicable.
16144707|NCT01822496|Drug|Crizotinib|250 mg, orally, twice daily for four 3-week cycles (12 weeks in total)
16144708|NCT01822496|Drug|Erlotinib|150 mg, orally, once daily for four 3-week cycles (12 weeks in total)
16144709|NCT01822496|Drug|Etoposide|50 mg/m2, IV, on days 1 and 8 of two 4-week cycles concurrent with radiation therapy. For patients receiving either erlotinib or crizotinib, etoposide will begin 2 weeks after the completion of erlotinib or crizotinib, as applicable.
16144710|NCT01822496|Drug|Paclitaxel|"Concurrent: 45 mg/m2, IV, days 1, 8, 14, 22, 29, and 36 of radiation therapy. For patients receiving either erlotinib or crizotinib, carboplatin will begin 2 weeks after erlotinib or crizotinib, as applicable.
~Consolidation: 4-6 weeks after completion of RT, 200 mg/m2, IV, days 1 and 22."
16144711|NCT01822483|Drug|Mycophenolate sodium|The conversion will be performed abruptly for all patients. Mycophenolate mofetil will be discontinued one day before the day of conversion (Day 1). Mycophenolate sodium will be introduced on day 1 with equivalent doses.
16144712|NCT01822483|Drug|Mycophenolate mofetil|Mycophenolate mofetil dose will be maintained or adjusted to keep 30 to 60 mg*h ml-1.
16144713|NCT01822457|Device|Nike FuelBand (NFB)|The Nike Fuel Band (NFB) is a wrist-worn sensor with a built-in accelerometer for motion quantification. It is programmed to estimate the number of steps taken per day, and also predict energy expenditure in units known as Nike Fuel. Accompanying software allows the user to set daily targets and monitor their activity through a graphical user interface.
16144714|NCT01822444|Other|Biomarker analysis|
16144715|NCT01822431|Radiation|metaiodobenzylguanidine scintigraphy|
16144716|NCT01822418|Drug|agomelatine|Augmentation of antipsychotic therapy with 25 to 50 mg agomelatine as a single oral dosage per day
16144717|NCT01822405|Drug|pentoxifylline with tocopherol|Pentoxifylline 800 mg/day (400 mg/12hours) + Vitamin E (alfa-tocopherol) 1000 mg/day,oral during 6 months
16144718|NCT01822405|Other|pentoxifylline+tocopherol + Hyperbaric Oxygen Therapy|"pentoxifylline 800 mg/day (400 mg/12hours) + Vitamin E (alfa-tocopherol) 1000 mg/day, oral during 6 months.
~Hyperbaric Oxygen Therapy at 100% in 25 sessions of 90 minutes 5 days per week (5 weeks) at 2,4 Ata in Hyperbaric chamber, starting in 3 or 9 weeks after randomization and beginning of drug treatment."
16144719|NCT01822392|Behavioral|Online Parent Management Training (Interactive)|
16144720|NCT01822392|Behavioral|Online Parent Management Training (Recorded)|
16144721|NCT01822379|Procedure|Melanocyte Keratinocyte transplantation|Transplantation of cells prepared with dispase
16144722|NCT01822366|Behavioral|Trauma-focused Cognitive Behavioral Therapy|
16144723|NCT01822353|Dietary Supplement|Dietary supplement|Milk, egg or nut oral immunotherapy
16144724|NCT01822340|Drug|HM10560A|Once weekly HM10560A
16144725|NCT01822340|Drug|Genotropin|Once daily Genotropin
16144726|NCT01822327|Behavioral|Contingency Management|CRA plus Vouchers contingent on drug abstinence with values the same across all patients
16144727|NCT01822327|Behavioral|Contingency Management|CRA plus Vouchers contingent on cocaine abstinence with more severe patients receiving greater value vouchers
16144728|NCT01822327|Behavioral|Contingency Management|CRA plus Vouchers earned independent of cocaine use
16144729|NCT01822314|Drug|Abraxane|Abraxane at the dosage of 125 mg/m2 will be delivered over 30 minutes on week 1, 2 and 3 followed by 1 week rest. week rest and will be repeated for 4 cycles followed by AC or EC (adriamycin or epirubicin and cyclophosphamide) on day 1 every 3 weeks for 4 cycles or FEC (fluorouracil, epirubicin, and cyclophosphamide) on day 1 every three weeks for 4 cycles
16144773|NCT01821937|Drug|faldaprevir(high dose)|faldaprevir(high dose) will be taken by 1 day single use and 10 days multiple use. the subjects will be assigned to high dose treatment in random order
16144731|NCT01822301|Procedure|Repeat Fat grafting|Fat grafting is a minimally invasive clinical procedure that has been widely used by plastic surgeons within reconstructive surgery for many years. Fat grafting is considered a standard of care procedure in plastic surgery. In brief, fat tissue to be used for grafting is harvested (usually from abdomen or thighs) with a small liposuction cannula in the operating room. The fat tissue is then sterilely centrifuged and allowed to decant before separating the fluid and oil layers from the fat tissue fraction. The aspirated fat is then loaded into 1cc syringes and injected into the facial deformity using specialized injection cannulas. In this study, we will treat 5 subjects from protocol (IRB # PRO09060101) with an additional fat graft treatment to assess whether this will increase fat graft retention over time. Additionally, data from our current study assessing volume retention after fat grafting for facial deformities (IRB # PRO09060101) with be used for comparison.
16144732|NCT01822288|Drug|Tibolone|Tibolone 2.5 mg once a day for patients with menopausal syndrome (self-paid)
16144733|NCT01822288|Drug|Estradiol & medroxyprogesterone acetate|Estradiol & medroxyprogesterone acetate once a day for patients with menopausal syndromes, for patients without the need for self-paid drug
16144734|NCT01822275|Drug|Chemotherapy with Temodar.|Once the patient has had surgery, patients will receive 6 weeks of radiation therapy with concurrent chemotherapy on protcol. This will be followed by a maximum of 12 cycles of adjuvent chemotherapy with Temodar.
16144735|NCT01822275|Radiation|Radiation therapy|
16144736|NCT01822262|Procedure|minimally invasive cholecystolithotomy with gallbladder reservation|
16144737|NCT01822262|Procedure|laparoscopic cholecystectomy|
16144738|NCT01822249|Drug|EPI-743|
16144739|NCT01822249|Drug|Placebo|
16144740|NCT01822236|Other|Craniosacral Therapy Program|The ten techniques of craniosacral therapy program are: Still Point (CV-4, Sacred Feet), diaphragms(pelvic, respiratory, thoracic inlet, hyoid, Occipital Cranial Base), Decompression L5-S1, Dural Tube Glide, Lift Front, Parietal Lift, Compression / decompression of the joint sphenobasilar, Temporary Technique, Compression / decompression of the temporomandibular joints, and Still Point CV-4.
16144741|NCT01822236|Other|One technique of craniosacral therapy|Decompression L5-S1: lumbosacral decompression
16144742|NCT01822223|Device|Dental implant-abutments|"At week-8, abutments will be removed and replaced with new Laser-Lok® abutments. An inter-arm randomization will assign subjects to one of two sub-groups per treatment arm. Sub-groups 1-a & 2-a: will receive a new Laser-Lok® abutment and a soft-tissue biopsy at week-8; a force-probe clinical attachment assessment of the same site will be delayed until week-16.
~Sub-groups 1-b & 2-b: will receive a new Laser-Lok® abutment and a force-probe clinical attachment assessment at week-8; a biopsy harvested from the same study site will be delayed until week-16.
~The implants will be restored following standard technique and a final visit will occur 6 months following permanent restoration."
16144743|NCT01822210|Drug|Botox|injection by gastroscopy (100 Allergen units)
16144744|NCT01822197|Device|Phototherapy|light will be administered at a minimum distance of 12 inches away to provide 10,000 lux
16144745|NCT01822171|Other|Discharge medication counseling from a pharmacist|Patient will be educated about proper dosing instructions, potential side effects, and when to recontact the treating physician office.
16144746|NCT01822171|Other|Home medication if needed|Patient will be provided with medication to take home, when needed.
16144747|NCT01822171|Other|Follow-up visit at Medication Therapy Management clinic|This comprehensive Medication Therapy Management clinic follow-up visit is scheduled for 7 days post hospital discharge. The approximately 1 hour visit is scheduled with a pharmacist to review current drug therapy and make recommendations, if needed, to improve medication utilization.
16144748|NCT01822158|Other|Vaginal Delivery Debrief Checklist|Participating team members will utilize Vaginal Delivery Debrief checklist
16144749|NCT01822145|Device|ICD|
16144750|NCT01822132|Drug|Extended release naltrexone|
16144751|NCT01822132|Drug|Placebo|
16144752|NCT01822119|Device|Baha Attract System|
16144753|NCT01822106|Other|Placebo|
16144754|NCT01822093|Biological|Cytovir-ADV|"A single dose 1x10e4 CD3+ T cells/kg patient weight of Cytovir ADV is prescribed to patients on exhibiting two consecutive PCR positive Adenovirus viraemia results > 1000 copies/ml. Patients are followed up by continued monitoring of Adenovirus viraemia results. If patients exhibit uncontrolled ADV viraemia at ≥ 4 weeks following the first cell dose, they will be prescribed a second cell dose of 10e5 CD3+ T cell/kg. Patients will be monitored for 6 months following infusion of Cytovir ADV.
~This is a feasibility/pilot study and has no control group"
16144755|NCT01822080|Drug|Dienogest (Visanne, BAY86-5258)|2 mg dienogest (DNG) once daily by mouth
16144756|NCT01822080|Drug|Placebo|Matching placebo once daily by mouth
16144757|NCT01822041|Drug|ARN-509|Single oral dose of 240 mg ARN-509
16144758|NCT01822028|Drug|Treatment A|Florastor® placebo. Zavesca® capsules dosed at 300 mg daily (one 100 mg capsule three times per day).
16144759|NCT01822028|Drug|Treatment B|"Florastor® capsules dosed at 1000 mg daily (two 250 mg capsules two times per day).
~Zavesca® capsules dosed at 300 mg daily (one 100 mg capsule three times per day)."
16144760|NCT01822015|Drug|Sirolimus|Given PO
16144761|NCT01822015|Drug|Idarubicin|Given IV
16144762|NCT01822015|Drug|Cytarabine|Given IV
16144763|NCT01822002|Procedure|Canalith repositioning maneuver|
16144764|NCT01821989|Dietary Supplement|Lactoferrin|dose of 100 mg/day
16144765|NCT01821989|Dietary Supplement|Lactoferrin|dose of 150 mg/kg/ twice daily
16144766|NCT01821989|Dietary Supplement|Placebo|in form of distilled water
16144767|NCT01821976|Procedure|Ertl Procedure|
16144768|NCT01821976|Procedure|Burgess Procedure|
16144769|NCT01821963|Drug|Pegylated Interferon Alfa 2a|Starting dose: 180 mcg subcutaneously once weekly.
16144770|NCT01821963|Drug|Ribavirin|Starting dose: 1,000 mg by mouth daily.
16144771|NCT01821963|Drug|Telaprevir|Starting dose: 750 mg by mouth 3 times a day.
16144772|NCT01821950|Behavioral|Yoga during physical education|12 to 16 weeks of group yoga classes (approximately 32 classes per student), 30-45 minutes per class, 2-3 times per week, during physical education class. Yoga program includes physical postures and movement, breathing exercises, partner/group games, deep relaxation and meditative techniques.
16144777|NCT01821898|Drug|Oral Budesonide|This group will receive oral viscous budesonide at a dose of 1 or 2 mg depending on the height divided twice a day
16144778|NCT01821898|Other|Elimination diet|This group will receive an elimination diet
16144779|NCT01821885|Behavioral|Spirometry and a brief advice to quit smoking|During a year, recruitment for active smoker patients was done by doctors in primary care medical offices. In the intervention group, after been randomized, one trained nurse completed the questionnaires and did the spirometry with bronchodilator test and set a date with its family doctor who did a minimal smoking cessation counselling intervention and informed the patients about the spirometry results according to established protocol.
16144780|NCT01821885|Behavioral|Brief advice to quit smoking|During a year, recruitment for active smokers patients occurred through doctors in primary care medical offices. After be randomized, in de control group, a nurse complete the questionnaires. Below, patients go to the family doctor who will do a minimal smoking cessation counselling intervention.
16144781|NCT01821872|Drug|Administration of paracetamol|Administration of 1g intravenous paracetamol
16144782|NCT01821859|Drug|Abraxane|Abraxane will be infused at a dose of 220 mg/m² in 20 mL normal saline per 100 mg vial over 30 minutes. This will follow the Bevacizumab infusion.
16144783|NCT01821859|Drug|Bevacizumab|Bevacizumab will be infused at a dose of 10 mg/kg in 100 mL normal saline over 30 minutes ± 10 minutes. It is given first, prior to the Abraxane infusion.
16144784|NCT01821846|Drug|liraglutide|Administered either alone or in combination therapy according to the package insert (PI). Self-administered once daily, at any time subcutaneously (s.c., under the skin) in the abdomen, thigh or upper arm).
16144785|NCT01821833|Dietary Supplement|Omega-3 fatty acid|"Patients receive omega-3 fatty acid capsules orally beginning 1 week prior to paclitaxel treatment.
~Capsule administration continues until paclitaxel is discontinued or for 12 weeks maximum (whichever comes first).
~Each 1-gram capsule contains approximately 465 mg eicosapentaenoic acid (EPA) and 375 mg docosahexaenoic acid (DHA)."
16144786|NCT01821833|Dietary Supplement|Placebo|"Patients receive placebo capsules orally beginning 1 week prior to paclitaxel treatment.
~Capsule administration continues until paclitaxel is discontinued or for 12 weeks maximum (whichever comes first)"
16144787|NCT01821833|Drug|Paclitaxel|Patients will receive, as part of their standard of care, weekly paclitaxel at 70 to 90 mg/m2 intravenously for a minimum of 2 months. Treatment 3 out of 4 weeks is allowed.
16144788|NCT01821820|Other|Pistachios|
16144789|NCT01821781|Drug|Transplant preparative regimen of alemtuzumab, fludarabine, thiotepa, and melphalan|Between days -23 and -15: alemtuzumab test dose, 3mg IV or SQ Day -14: alemtuzumab, 10mg IV or SQ Day -13: alemtuzumab, 15mg IV or SQ Day -12: alemtuzumab, 20mg IV or SQ Days -8 to -4: fludarabine, 30mg/m2 IV Day -4: thiotepa 4mg/kg IV q 12 hours Day -3: melphalan, 140mg/m2 IV Day 0: stem cell infusion Day +7: G-CSF
16144790|NCT01821768|Procedure|Sentinel Lymph Node Biopsy|
16144791|NCT01821755|Behavioral|Foster parent intervention|parent management training for foster parents, consisting of 10 individual home visits and 3 group sessions. Duration is four months
16144792|NCT01821742|Other|Ultrasound cardiac output measurement|
16144793|NCT01821729|Drug|FOLFIRINOX|Oxaliplatin via IV on Day 1 over 2 hours; Irinotecan via IV on Day 1 over 90 minutes, 5FU via IV on Day 1 over 2-4 minutes
16144794|NCT01821729|Drug|Losartan|Taken orally every day during Phase I for all 8 cycles
16144795|NCT01821729|Radiation|Proton Beam Radiation|30-45 minutes per day, daily Monday-Friday
16144796|NCT01821716|Biological|Prick test Dermatophagoides pteronyssinus allergen extract|"This is an open, unblinded and non randomized biological as proposed by the Nordic Guidelines.
~Three concentrations of Dermatophagoides pteronyssinus allergen extract, together with a positive and negative control, using 10 mg/ml histamine dichloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm. This test will be referred to as the Titrated Skin Prick test."
16144797|NCT01821703|Drug|LY3045697|Administered as oral solution
16144798|NCT01821703|Drug|Placebo|Administered as oral solution
16144799|NCT01821703|Drug|Spironolactone|Administered as capsule
16144800|NCT01821703|Drug|Placebo|Administered as capsule
16144801|NCT01821690|Drug|Buspirone|Buspirone/placebo will be given in increasing increments of 15 mg as needed. Subjects will start with 15 mg on day one and end with 60 mg on day 91 or placebo equivalent. Dose is titrated based on treatment response.
16144802|NCT01821690|Drug|Placebo|The placebo tablets taste and look identical to buspirone.
16144803|NCT01821677|Drug|Low Dose Danazol|
16144804|NCT01821677|Drug|Placebo|
16144805|NCT01821664|Device|Prosthetic vascular graft|Implantation of a prosthetic vascular graft
16144806|NCT01821651|Device|HeartNavigator|Procedure with software
16144807|NCT01821651|Device|EchoNav|Procedure with software
16144808|NCT01821651|Other|Control-Group EN|Procedure without software
16144809|NCT01821651|Other|Control-group HN|Procedure without software
16144810|NCT01821625|Drug|Eltrombopag|Study patients will be provided eltrombopag to raise platelet levels before anti-hepatitis C drugs are initiated, and will continue eltrombopag throughout the study.
16144811|NCT01821612|Drug|oxaliplatin|IV
16144812|NCT01821612|Drug|irinotecan|IV
16144813|NCT01821612|Drug|leucovorin|IV
16144814|NCT01821612|Drug|5-fluorouracil|IV
16144815|NCT01821612|Drug|capecitabine|PO
16144816|NCT01821612|Radiation|radiation|
16144817|NCT01821612|Procedure|surgery|
16144818|NCT01821612|Drug|gemcitabine|IV
16144819|NCT01821599|Other|Nonaccelerated Rehabilitation|Nonaccelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction in 6 months of recovery.
16144820|NCT01821599|Other|Accelerated Rehabilitation|Accelerated Rehabilitation After Anterior Cruciate Ligament Reconstruction in 4 months of recovery.
16144821|NCT01821586|Other|Modified ORS-1|
16144822|NCT01821586|Other|Modified ORS-2 (ReSoMal)|
16144823|NCT01821586|Other|Modified ORS-3 (Benefibre)|
16144824|NCT01821573|Drug|botulinum toxin type A|"Experimental arm group:
~150 Units in rectus femoris ( 3 ml and 3 points)
~70 units in medial gastrocnemius (1.4 ml and 1 point)
~70 units in lateral gastrocnemius ( 1.4 ml and 1 point)
~60 units in soleus ( 1.2 ml and 3 points)"
16144912|NCT01820936|Drug|Sequence 5: PCI-32765|After completion of the 4-way crossover, an additional separate cohort of 8 subjects were enrolled. These subjects participated in 1 treatment period to document safety and PK
16144825|NCT01821573|Drug|injection of NaCl 0.9%|"Placebo comparator group: injection of NaCl 0.9%:
~3 ml of NaCl 0.9% in rectus femoris in 3 points
~1.4 ml of NaCl 0.9% in medial gastrocnemius in 1 point
~1.4 ml of Nacl 0.9% in lateral gastrocnemius in 1 point
~1.2 ml of NaCl 0.9% in soleus in 3 points"
16144826|NCT01821560|Drug|Baclofen|
16144827|NCT01821560|Drug|placebo|
16144828|NCT01821547|Drug|Hepatitis B vaccine|Immunisation with HepB vaccine (HBvaxPRO, 10μg/ml, Sanofi Pastuer) via intramuscular injection into the non-dominant deltoid (part 1 only).
16144829|NCT01821534|Other|No Intervention|No treatment (intervention) was administered.
16144830|NCT01821521|Drug|AGSPT_L20|
16144831|NCT01821521|Drug|Pantoloc 40mg|
16144832|NCT01821508|Other|Clinical Treatment|metabolic surgery for diabetes and weight control
16144833|NCT01821508|Procedure|Roux-En-Y gastric bypass surgery|laparoscopic surgical procedure with Endoscopic Surgical Stapler
16144834|NCT01821495|Biological|DC-CIK|
16144835|NCT01821495|Biological|Dendritic and Cytokine-induced Killer Cells|Concurrent of radiotherapy and chemotherapy plus 3 cycles of Dendritic and Cytokine-induced Killer Cells(DC-CIK) treatment
16144836|NCT01821482|Biological|Dendritic and Cytokine-induced Killer Cells|
16144837|NCT01821469|Behavioral|psychoeducation|Bipolar disorders are educated to learn about their pathology
16144838|NCT01821456|Drug|Antiinfectives|To analyze to efficacy of (novel) drug therapies
16144839|NCT01821443|Other|Stereotactic radiosurgery (SRS)|"Dose & prescription The dose will be prescribed to the isodose surface, which encompasses the margin of the metastasis (50-90% [maximum=100%]), as defined by target delineation on the imaging studies.
~The prescribed dose is dependent on the prescription isodose volume (IDV). The prescription IDV is defined as the volume (cm3) that is encompassed by the prescription isodose line (IDL)."
16144840|NCT01821430|Drug|Pregabalin|Titration of intervention will begin with 50mg PO BID x 2 days, then 100mg PO BID x 2 days, then 150mg PO BID X 2 days, then on day 7 full dose of Pregabalin 400mg PO QD for six weeks
16144841|NCT01821430|Drug|Placebo|Placebo group will follow the same titration as the pregabalin group
16144842|NCT01821417|Device|Microtextured dental implant treatment|Microtextured dental implant treatment will include a surgically inserted device implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists.
16144843|NCT01821417|Device|Dental implant treatment|Treatment with dental implants; implants with a machined collar will be surgically implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists.
16144844|NCT01821404|Drug|Atorvastatin|Capsules including 80 mg of atorvastatin
16144845|NCT01821404|Drug|Placebo|Similar capsules as in the atorvastatin arm, but without the active ingredient
16144846|NCT01821391|Drug|NDL-PDT|Metvix natural daylight photodynamic therapy
16144847|NCT01821391|Drug|c-PDT|Metvix conventional photodynamic therapy
16144848|NCT01821391|Drug|placebo c-PDT|Metvix placebo conventional photodynamic therapy
16144849|NCT01821378|Drug|Lurasidone|Lurasidone 20 mg once daily
16144850|NCT01821378|Drug|Lurasidone 80 mg once daily initially rerandomized either to 80 mg or 160 mg at week 2|Lurasidone 80 mg once daily
16144851|NCT01821378|Drug|Placebo|Once Daily
16144852|NCT01821352|Device|Erchonia Obesity Laser|10 independent 17 milliwatts 532 nm green diode lasers
16144853|NCT01821352|Device|Placebo Laser|Emits light that has no therapeutic effect
16144854|NCT01821313|Other|Moderate exercise|
16144855|NCT01821313|Other|High Intensity Interval Exercise|
16144856|NCT01821287|Other|CHD|The study is not providing an intervention but rather is observational/studying factors that could contribute to nutritional failure in single ventricle CHD infants
16144857|NCT01821274|Drug|Diltiazem Hydrochloride 2% Cream|0.2 g applied topically to the infrascapular area of the back.
16144858|NCT01821274|Drug|Vehicle Cream|0.2 g (contains no active pharmaceutical ingredient) applied topically to the infrascapular area of the back.
16144859|NCT01821274|Drug|0.1% solution o sodium lauryl sulfate (SLS)|0.2 mL applied topically to the infrascapular area of the back will serve as a positive control.
16144860|NCT01821274|Drug|Saline 0.9%|0.2 mL applied topically to the infrascapular area of the back will serve as a negative control.
16144861|NCT01821261|Device|Mouth Rinse 19668-012|20 ml of experimental mouth rinse 19668-012 for 30 seconds, twice daily
16144862|NCT01821261|Drug|Mouth Rinse 500347078842|10 ml of mouth rinse 500347078842 for 60 seconds, twice daily
16144863|NCT01821261|Drug|Toothpaste 035000513007|Approximately one inch of toothpaste 035000513007, twice daily
16144864|NCT01821248|Drug|Gemcitabine, Cisplatin, S-1|"Preoperative chemotherapy (GCS) 3 cycles -FDG-PET- surgery
~GCS therapy Gemcitabine 1000mg/m2/day1 Cisplatin 25mg/m2/day1 S-1 100mg/body/day1-7"
16144865|NCT01821235|Drug|Neurontin® (gabapentin) batch A|Neurontin® 800 mg tablets (gabapentin) batch A, given 2 times
16144866|NCT01821235|Drug|Neurontin® (gabapentin) batch B|Neurontin® 800 mg tablets (gabapentin) batch B, given 1 time
16144867|NCT01821235|Drug|Gabasandoz® (gabapentin) batch A|Gabasandoz® 800 mg tablets (gabapentin) batch A, given 2 times
16144868|NCT01821235|Drug|Gabasandoz® (gabapentin) batch B|Gabasandoz® 800 mg tablets (gabapentin) batch A, given 1 time
16144869|NCT01821222|Device|Wired mothers|"The wired mothers SMS component provided health education and appointment reminders to encourage attendance at routine antenatal care, skilled delivery attendance and postnatal care. A specially-designed software automatically generated and sent text messages throughout the pregnancy until six weeks after delivery. The frequency and content of the messages varied according to the women's gestational age.
~Mobile phone vouchers allowed all wired mothers to communicate directly with primary health care providers. Primary health care facilities randomised for intervention and hospitals were provided with a mobile phone with sufficient credit, while wired mothers were given a phone voucher with modest credit and a card with the phone number of her local primary health care provider."
16144913|NCT01820923|Device|Transcranial direct current stimulation (tDCS)|2 mA of intensity, 20 minutes of stimulation over the left fronto-temporal prefrontal cortex.
16144914|NCT01820923|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|Frequency of stimulation: 10Hz. Interstimulus interval: 1 min. Number of stimuli per session: 300. Number of sessions per week: 4 Total number of stimuli: 1.200
16144957|NCT01820611|Device|Arcos Revision Stem System|Revision Hip System
16144870|NCT01821209|Procedure|Placement of sling|Placement of a retropubic urethral sling will involve dissection and harvesting of the right and left vas deferens, which we will be taken out of the body by the bed side assistant who will suture the two vas deferens together in a side to side fashion with the smaller of the two vas deferens placed in the middle of the larger one. A single 3-0 V-lock suture on a CV23 needle will be placed through one end of the vas sling and then passed into the body by the bed side assistant. The sling will then be placed on the rectum below the site of the vesicourethral anastamosis and the anastamosis will be completed. The sling will then be placed around the vesicourethral anastomosis, suspended to the pubic symphysis and tensioned to allow elevation of the vesicourethral anastomosis.
16144871|NCT01821196|Procedure|biopsy|biopsies will be evaluated with immunohistochemistry and gene expression studies
16144872|NCT01821170|Drug|Methylphenidate|Patient will take treatment during two months
16144873|NCT01821170|Device|cognitive remediation|Patient will have 12 sessions during 6 to 8 weeks
16144874|NCT01821170|Behavioral|supportive psychotherapy|Patients will have 12 sessions during 6 to 8 weeks
16144875|NCT01821170|Other|neuropsychological tests|neuropsychological tests will assess attentional and executive performance
16144876|NCT01821157|Procedure|Open-flap|Open-flap(control group; n=28 sides/105 teeth): An internal beveled incision was performed at the buccal aspect of the involved teeth. Afterwards, a sulcular incision was completed to allow gingival tissue removal. A full-thickness mucoperiosteal flap was reflected to remove and remodel bone tissue by means of surgical chisels, as necessary, until a 3mm distance was achieved between the bone crest and the cement-enamel junction (CEJ). The exposed root surfaces were carefully planed with curettes. Interrupted sutures were performed at the papilla to allow GM stabilization in the CEJ position.
16144877|NCT01821157|Procedure|Flapless|FL (test group; n=28 sides/105 teeth): Internal beveled and sulcular incisions and gingival tissue removal were performed as above described for the control group, replacing the GM in the CEJ position. However, the alveolar bone was removed and remodeled, as necessary, using micro chisels, via incisions, without flap elevation. The root surfaces were also carefully planed via incisions. The required distance of 3mm between the bone crest and the CEJ was checked by inserting a periodontal probe into the incision. Sutures were not performed.
16144878|NCT01821144|Behavioral|Salt reduction|Salt reduction
16144879|NCT01821144|Other|Control|No salt awareness education
16144881|NCT01821118|Biological|Ponezumab|Infusion of Ponezumab (Day 1=10mg/kg; Day 30 and Day 60 dose = 7.5mg/kg) or placebo (saline); administered via infusion for a total infusion time of 20 minutes.
16144882|NCT01821118|Other|placebo|placebo (saline)- given via infusion total infusion time of 20 minutes
16144883|NCT01821105|Procedure|PET Scan|All patients will receive whole body PET scans (chest-abdomen-pelvis).
16144884|NCT01821105|Procedure|CT Scan|All patients will receive CT scans of the abdomen and pelvis with contrast.
16144885|NCT01821105|Radiation|fludeoxyglucose F 18|Given IV
16144886|NCT01821105|Procedure|computer-aided detection/diagnosis|Undergo computer-aided detection/diagnosis during surgery
16144887|NCT01821092|Procedure|implant insertion and abutment connection|After implant insertion, immediate or in healed ridge, the titanium abutment with switching platform will be connected
16144888|NCT01821092|Device|osseointegrated implant|Osseointegrated Implant Insertion
16144889|NCT01821079|Drug|PF-05175157|Single 200 mg dose of PF-05175157 administered as powder in capsule (2x100 mg)
16144890|NCT01821079|Drug|PF-05175157|Single 200 mg dose of PF-05175157 administered as tablet formulation (2x100 mg)
16144891|NCT01821079|Drug|PF-05175157|Single 200 mg dose of PF-05175157 administered as tablet formulation (2x100 mg)
16144892|NCT01821079|Drug|PF-05175157|Single 200 mg dose of PF-05175157 administered as tablet formulation (2x100 mg)
16144893|NCT01821066|Drug|PD-0332991 alone|PD-0332991 is administered alone as a single oral 125 mg dose on Day 1 of Period 1.
16144894|NCT01821066|Drug|Tamoxifen 60 mg|On Days 1-4 of Period 2, tamoxifen is administered daily as 60 mg oral doses (using three 20mg tablets).
16144895|NCT01821066|Drug|Tamoxifen 20 mg|On Days 5-27 of Period 2, tamoxifen is administered daily as 20 mg oral doses.
16144896|NCT01821066|Drug|PD-0332991 combination|PD-0332991 is administered in combination with tamoxifen on Day 22 of Period 2 as a single 125 mg oral dose.
16144897|NCT01821040|Drug|Lodotra®|Lodotra, starting dose of 15mg administered in the evening
16144898|NCT01821040|Drug|Prednisone IR (immediate release)|Prednisone IR 15mg daily start dose (immediate release) administered in the morning,
16144899|NCT01821027|Drug|Simvastatin|One 40 mg tablet taken orally (by mouth) on Day 1 and Day 7.
16144900|NCT01821027|Drug|Canagliflozin (JNJ-28431754)|One 300 mg dose (ie, one 100 mg and one 200 mg over-encapsulated tablet) taken orally (by mouth) on Days 2 through Day 7.
16144901|NCT01821014|Other|Telemedicine|Patients undergo a detailed history and examination to the degree that is possible using the videoconference program, skype, a digital camera for high-resolution images, and an electronic stethoscope. A clinic volunteer aids with examination, translation and documentation.
16144902|NCT01821014|Other|In-person physician interaction|Patients undergo a detailed history and examination by an in-person physician. A clinic volunteer aids with examination, translation and documentation, as needed.
16144903|NCT01821001|Drug|Vaginal Bromocriptine|Patients will receive 2.5 mg of vaginal bromocriptine tablet twice a day for the intervention. This will be administered for 6 months.
16144904|NCT01820975|Dietary Supplement|High protein intake|
16144905|NCT01820975|Other|Placebo comparator|No protein intake
16144906|NCT01820962|Procedure|heparin|when not in use CVCs are locked with heparin
16144907|NCT01820962|Procedure|concentrated citrate|when not in use the CVC is locked with concentrated citrate
16144908|NCT01820936|Drug|Sequence 1: PCI-32765|Period 1 = Treatment D, Period 2 = Treatment C, Period 3 = Treatment A, Period 4 = Treatment B
16144909|NCT01820936|Drug|Sequence 2: PCI-32765|Period 1 = Treatment A, Period 2 = Treatment D, Period 3 = Treatment B, Period 4 = Treatment C
16144910|NCT01820936|Drug|Sequence 3: PCI-32765|Period 1 = Treatment B, Period 2 = Treatment A, Period 3 = Treatment C, Period 4 = Treatment D
16144911|NCT01820936|Drug|Sequence 4: PCI-32765|Period 1 = Treatment C, Period 2 = Treatment B, Period 3 = Treatment D, Period 4 = Treatment A
16144915|NCT01820923|Device|Transcranial Direct Current Stimulation (SHAM)|The electrodes of stimulation will be applied in the left fronto-temporal prefrontal cortex, but the device will be turned off.
16144916|NCT01820923|Device|Repetitive Transcranial Magnetic Stimulation (SHAM)|The coil will be applied on the left fronto-temporal prefrontal cortex, but the device will be turned off.
16144917|NCT01820910|Drug|Doxycycline|All enrolled patients will be treated with doxycycline 100 mg bid daily, orally, for four weeks followed by four weeks rest, repeated for three cycles. Response will be assessed by MRI (magnetic resonance imaging) and ophthalmologic examination at the end of the planned treatment. Patients who will achieve complete response, partial response or have a stable disease at 3 months from upfront doxycycline will be monitored for infection re-occurrence and assessed for response with MRI and ophthalmologist evaluation every six months for the first five years.
16144918|NCT01820897|Drug|Fosfomycin-Trometamol|
16144919|NCT01820897|Drug|Sulfamethoxazole trimethoprim|
16144920|NCT01820884|Procedure|TH|Total hysterectomy
16144921|NCT01820884|Procedure|TH/BSO|Total hysterectomy and bilateral salpingo-oophorectomy
16144922|NCT01820884|Procedure|BPLND|bilateral pelvic and para-aortic lymph node dissection
16144923|NCT01820871|Other|Self-Management Using Smartphone Application for Type2 DM|
16144924|NCT01820871|Other|self-management using booklet for management type 2 DM|
16144925|NCT01820858|Drug|Paclitaxel|175 mg/m(2), intravenously (IV)
16144926|NCT01820858|Drug|Paraplatin (Carboplatin Injection)|AUC=5, IV
16144927|NCT01820858|Radiation|Pelvic Radiation|45-50 Gy
16144928|NCT01820858|Radiation|Vaginal Brachytherapy 1|5 Gy, 3 times
16144929|NCT01820858|Radiation|Vaginal brachytherapy 2|5 Gy, 2-4 times
16144930|NCT01820832|Drug|Calcitriol|Calcitriol 0.5 ug/BIW for 24 weeks.
16144931|NCT01820806|Drug|100 mg dose of [14C] GLPG0634|Subjects will be dosed with a single oral 100 mg dose of [14C] GLPG0634 on one occasion
16144932|NCT01820793|Drug|Cefoxitin|proof of concept study to evaluate the efficacy of cefoxitin (2 grams every 6 hours for 10 days) in 40 women presenting acute ESBL-producing E.coli pyelonephritis without severity symptoms and to perform on half of the participants repeated measurements of cefoxitin serum levels (6 blood samples within 6 hours following an injection).
16144933|NCT01820780|Other|Natriuretic peptides levels to J7 and J14|
16144934|NCT01820780|Other|Consultations specialized to J7 and J14|Optimization of treatments Education on the signs of alert of the disease and on the medicines Reduction of the rate of BNP or NTproBNP = 30 % between the exit of the hospitalization and the second consultation Planning of an adapted coverage
16144935|NCT01820780|Other|Phone calls in 6 months and 12 months|
16144936|NCT01820780|Other|Natriuretic peptides levels at 6 months|
16144937|NCT01820780|Other|Consultation with the general doctor or the cardiologist to J30 with blood results|
16144938|NCT01820767|Drug|Paricalcitol|Oral Paricalcitol. parathyroid hormone i mcg/100. 3 days per week, the same day as haemodialysis is done, during 12 weeks.
16144939|NCT01820767|Drug|Paricalcitol, atorvastatin|"Oral Paricalcitol. parathyroid hormone i mgc/100. 3 days a week, the same day as haemodialysis, during 12 weeks.
~Atorvastatin: 20 mg/day oral (1 take) during 12 weeks."
16144940|NCT01820767|Drug|Atorvastatin|Atorvastatin: 20 mg/day oral (1 take) during 12 weeks
16144941|NCT01820754|Drug|Ipilimumab|"Neoadjuvant (Pre-Surgery): Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes
~Adjuvant (Post-Surgery): Ipilimumab 10 mg/kg IV every 3 weeks times 2 doses beginning 4 weeks postoperative ( up to 10 weeks if needed for recovery)
~Maintenance: Ipilimumab 10 mg/kg/IV every 12 weeks times 2 doses"
16144942|NCT01820754|Drug|Paclitaxel, Cisplatin, Carboplatin|"Neoadjuvant (Pre-Surgery) Cycle 1: Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin AUC 6 IV over 30-60 minutes on day 1(Every 21 days x 1 cycle)
~Cycles 2 and 3: Ipilimumab 10 mg/kg IV over 90 minutes, Paclitaxel 175 mg/m2 IV over 3 hours , followed by Cisplatin 75 mg/m2 IV over 60 minutes or carboplatin AUC 6 IV over 30-60 minutes on day 1(Every 21 days x 2 cycles)"
16144943|NCT01820728|Drug|DA-3801 Injection|
16144944|NCT01820728|Drug|Gonal-F®|
16144945|NCT01820715|Drug|600㎍ of DA-3030 Injection|
16144946|NCT01820715|Drug|Placebo|
16144947|NCT01820702|Other|Defined Training Programme|A Smith Machine with fixed rails was used to guide the heel raise and squat exercises in the vertical axis. A metronome was used to direct the subjects during the performance of the exercises. Squats and heel raises were performed against body weight plus the additional weight of the barbell (15 kg). The heel raises were performed with straight knees and without ankle dorsiflexion. The shallow squats were performed continuously for 3 minutes. The hopping and the cross-hopping exercises were performed without Smith Machine. The bilateral hops were performed at ~ 3 repetitions per second with 15-s rest insertions between each set. Cross-hopping was performed continuously for 3 minutes against ~ 1.3 repetitions per second. Except for the duration of the static squat, with progressed from 45 s at HDT1 to 70 s at HDT5, none of the exercises were progressed during the study. Including the scheduled rest pauses, the LRT sessions were completed in 24 minutes.
16144948|NCT01820689|Other|Tympanometry measurement|The tympanometry measurement will be verify and compared with the time of palatoplasty.
16144949|NCT01820676|Device|iUni G2+|The iUni G2+ Unicompartmental Resurfacing Device (iUni) is an FDA cleared and CE Marked implant designed for patients with damage isolated to either the medial or lateral tibiofemoral compartment of the knee. The patient-specific iUni is designed from a CT scan of an individual patient's knee using a design process which interactively maps the diseased area and defines the extent of misalignment present in the knee. This process allows definition of the shape and size of the femoral and tibial components of the implant, as well as the disposable instrumentation (Fitz).
16144950|NCT01820663|Other|Modified Atkins Diet|A high fat, high protein, low- carbohydrate diet
16144951|NCT01820663|Other|Control diet|The control diet is a diet determined by the attending physician caring for the patient and may consist of either a low sodium diet, a low sodium/ low cholesterol diet, a regular diet or a diabetic diet.
16144952|NCT01820650|Device|iTotal G2 CR Knee Replacement System|Total Knee replacement
16144953|NCT01820637|Device|The Boston Scientific DES SFA Paclitaxel-Eluting Self-Expanding Stent System (DES SFA)|Drug-eluting SFA self-expanding stent
16144954|NCT01820624|Drug|tretinoin|Given PO
16144955|NCT01820624|Drug|lithium carbonate|Given PO
16144956|NCT01820624|Other|laboratory biomarker analysis|Correlative studies
16144958|NCT01820598|Device|Multisite NMES training during 6 weeks|
16144959|NCT01820585|Drug|Placebo|Tablets
16144960|NCT01820585|Drug|ESL 400 mg|tablets
16144961|NCT01820585|Drug|ESL 800 mg|tablets
16144962|NCT01820585|Drug|ESL 1200 mg|tablets
16144963|NCT01820572|Drug|Belatacept|
16144964|NCT01820572|Drug|Tacrolimus|
16144965|NCT01820572|Drug|Cyclosporine|
16144966|NCT01820559|Drug|Placebo|Tablets
16144967|NCT01820559|Drug|ESL 1200 mg|Eslicarbazepine acetate was supplied in 400-mg and 600-mg tablets and was administered with a dose of 800 or 1200 mg QD in the evening by the oral route.
16144968|NCT01820559|Drug|ESL 800 mg|Eslicarbazepine acetate was supplied in 400-mg and 600-mg tablets and was administered with a dose of 800 or 1200 mg QD in the evening by the oral route.
16144969|NCT01820533|Other|Cell Phone Survey|Eight item survey for smokers being treated in the YNHH Emergency Dept. The survey asks about the type of cell phone(s) subjects have, how much they pay for cell service monthly, housing status, and if they receive any benefit that would qualify them for the Lifeline program.
16144970|NCT01820520|Drug|brilliant blue G|Double staining with brilliant blue G 0.025% for macular surgery
16144971|NCT01820507|Device|Optiflow (Fisher&Paykel)|The described method of oxygen supply will be maintained continuously for the first 24 hours after extubation.
16144972|NCT01820507|Device|Nasal cannulae or controlled oxygen concentration mask|The described method of oxygen supply will be maintained continuously for the first 24 hours after extubation.
16144973|NCT01820494|Other|Experimental Infant Formula|Infant formula to be fed ad libitum
16144974|NCT01820481|Drug|WIN-901X dose level 1|100mg Bid, PO, 12weeks
16144975|NCT01820481|Drug|WIN-901X dose level 2|200mg Bid, PO, 12weeks
16144976|NCT01820481|Drug|WIN-901X dose level 3|300mg Bid, PO, 12weeks
16144977|NCT01820481|Drug|Placebo|Bid, PO, 12weeks
16144978|NCT01820468|Behavioral|Adapted critical time intervention team|
16144979|NCT01820455|Drug|Chlorhexidine, Mupirocin|Chlorhexidine baths and intranasal mupirocin ointment once daily for five days
16144980|NCT01820455|Drug|Soap baths, Lubricating Jelly|Soap and water baths with lubricating jelly to the nares, once daily for 5 days
16144981|NCT01820442|Drug|Lofexidine HCl|Lofexidine HCl tablets titrated in ascending doses of 0.2 mg (1 tablet) QID starting at 0.4 mg (2 tablets) QID [e.g. Day 1 0.4 mg (2 tablets) QID, Day 2 0.6 mg (3 tablets) QID, etc.] as described in the treatment arm. Option to down-titrate to 0.2 mg (1 tablet) QID if 0.4 mg (2 tablets) QID dose not initially tolerated.
16144982|NCT01820442|Drug|Lofexidine-matching sugar pill|Lofexidine-matching sugar pill tablets titrated in ascending doses of 1 tablet starting at 2 tablets QID (e.g. Day 1 2 tablets QID, Day 2 3 tablets QID, etc.) as described in the treatment arm. Option to down-titrate to 1 tablet QID if 2 tablets not initially tolerated.
16144983|NCT01820416|Radiation|Low-level Laser Therapy|Portable unit containing two laser diodes producing 532 and 635 nm wavelengths. Both diodes produced energy levels of 7.5 mw (class IIIb). Beams from both diodes were dispersed through lenses to create parallel line-generated beams, rather than spots. The 532 nm light was constant, and the 635 nm light was pulsed, with frequencies of 15 and 33 Hz. The pulsing alternated between frequencies every 30 seconds.
16144984|NCT01820416|Other|Placebo Comparator: Disabled Laser|Portable unit containing two DISABLED laser diodes. Same protocol was followed as for the Experimental (radiation) group, except that the disabled diodes produced no radiation.
16144985|NCT01820403|Other|portion size kcal of box lunch|
16144986|NCT01820377|Behavioral|Aboriginal Youth Mentorship Program|High school students volunteer as mentors, and develop an after-school program that they then deliver to children in grade 4. The mentors meet twice a week. The first day, they develop an activity plan and decide roles and responsibilities to ensure successful delivery of each activity. The second day, they deliver the program to the grade 4s, which incorporates a healthy snack, 45-minutes of physical activity, and educational games/activities. Grade 4s are our intervention group
16144987|NCT01820364|Drug|LGX818|BRAF inhibitor. LGX818 was administered QD orally on a daily schedule (21-day cycles) as a flat-fixed dose and not by body weight or body surface area. LGX818 100 mg capsules and 50 mg capsules.
16144988|NCT01820351|Other|static stretching exercise on 3 times a week during 8 weeks. Sets number: three of 30 seconds with intervals of equal duration|
16144989|NCT01820338|Behavioral|Behavioral Child Tx Contacts|Each parent and child dyad will participate in group meetings. Children and parents will meet in simultaneous, but separate, groups at each meeting. The intervention will include 12 sessions over 16 weeks. Families will also participate in a maintenance intervention for the next eight months. The primary treatment objectives will be to decrease caloric intake in a nutritionally sound manner and to increase moderate intensity exercise. Changes in dietary habits will be addressed via a modified version of the Stoplight System. Children and adults will be encouraged to eat a well-balanced diet based on the food guide pyramid. Parents and children will also be given pedometers and they will be asked to keep track of the number of steps they take each day. Each week parents and children will set goals to gradually increase physical activity. Parent and their children will be asked to record what they eat and drink, as well as their physical activity on daily food logs.
16144990|NCT01820338|Behavioral|Behavioral Parent-Tx Contacts|Only the participating parent(s) will attend group meetings. The intervention will include weekly sessions for the first 8 weeks and biweekly sessions for the next 8 weeks. They will also participate in a maintenance intervention for eight months. Each session will last 90 minutes. The sessions for parents in the parent-only program will be structured the same as the parents sessions for the family-based intervention and will also cover the same topics. As with the family-based intervention, the parent and their children assigned to the parent-only intervention will be asked to record what they eat and drink, as well as their physical activity, on a daily basis. Each week group interventionists will model the goal setting process with parents and suggest a general range of age-appropriate dietary and physical activity targets that might be appropriate for each child and parent.
16145032|NCT01820091|Drug|Fusilev|Fusilev will be administered either four times a day (QID) (6 hours apart, ±10 minutes), twice a day (BID) (8 hours apart, ±10 minutes) or once a day (QD) by IV push (3-5 minutes) at a dose of 5 mg/m2 according to the cohort to which patients are assigned.
16145033|NCT01820078|Drug|Experimental arm|Oral paricalcitol, 1 ug/day, plus daily treatment. 6 months (all study)
16145156|NCT01819012|Drug|Isoflurane 1.5 MAC|10 min-inhalation of each concentration of isoflurane, 1.5 MAC
16144991|NCT01820338|Other|Dietary and Physical Activity Information|Both the child and parent will attend the treatment sessions in this program. The condition will include a series of meetings addressing key aspects of nutrition, physical activity, and health promotion such as national guidelines regarding proper nutrition, guidelines for physical activity, strategies to cope with stress, healthy sources and guidelines for intake of fiber, calcium, protein, grains & carbohydrates. Topics will also include use of vitamin & mineral supplements, dental and sleep hygiene, self-esteem, family communication, and assertiveness training in dealing with peer victimization. The families in the Health Education group will not receive training in behavioral self-regulation strategies, such as goal setting and self-monitoring. Children will participate in a group physical activity during each session such as frisbee, jump rope, stoplight tag. They will also sample healthy snacks such as pretzels or fruits and vegetables.
16144992|NCT01820325|Drug|Buparlisib|
16144993|NCT01820325|Drug|Buparlisib placebo|Placebo + Carboplatin + Paclitaxel
16144994|NCT01820325|Drug|Carboplatin|
16144995|NCT01820325|Drug|Paclitaxel|
16144996|NCT01820312|Radiation|Low-Dose Fractionated Radiation Therapy/Paclitaxel|
16144997|NCT01820299|Drug|Grape Seed Extract|All patients enrolled to the study will take Grape Seed Extract alone for 21 days.
16144998|NCT01820299|Drug|Vitamin D|From Day 22 until Day 64 of the study, patients will take Grape Seed Extract and Vitamin D together. Patients will take Vitamin D once at a day at 4000 IU.
16144999|NCT01820286|Behavioral|Positive psychology intervention|
16145000|NCT01820286|Behavioral|Recollection intervention|
16145001|NCT01820260|Drug|Ingenol mebutate gel|
16145002|NCT01820260|Drug|placebo|
16145003|NCT01820247|Drug|enteral nutrition|
16145004|NCT01820247|Drug|Tripterygium glycosides|
16145005|NCT01820234|Other|In-person dermatology evaluation|Every patient will be evaluated by an in person dermatologist present at the screening.
16145006|NCT01820234|Other|Store-and-forward teledermatology evaluation|Every patient will be evaluated online via a store and forward teledermatology modality.
16145007|NCT01820221|Procedure|Suture vs. staples closure method after c-section in obese women.|Random card draw to either suture skin closure or staple skin closure arm of study.
16145008|NCT01820208|Drug|G-CSF|G-CSF would be given at a dose of 5 microgram/kg daily for 5 days followed by once in 3 days for a total of 12 doses.
16145009|NCT01820208|Drug|Placebo|Placebo would be given s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses)
16145010|NCT01820195|Drug|Oral N-Acetyl Cystein|Oral N-Acetyl Cystein 600 mg bid started the day before contrast administration and continue the day after exposure to contrast
16145011|NCT01820195|Drug|IV N-Acetyl Cystein|Bolus IV administration of 1200 mg N- Acetyl Cystein half an hour before contrast media administration
16145012|NCT01820195|Drug|Placebo group|The patients in this group will be received both oral placebo and IV placebo
16145013|NCT01820182|Device|capsule endoscopies|Patients inclusion following inclusion criterias Randomization of capsule ingestion order Videocapsule recording by the two capsules Reading of the two capsules films in randomized order by two different readers in each center Reviewing of discordant capsule films by an expert panel
16145014|NCT01820169|Device|;Accu-Chek Compact Plus LCM bulk Japan|HbA1c would be changed by more careful control in blood glucose with SMBG.
16145015|NCT01820156|Device|Home Respiratory Polygraphy|
16145016|NCT01820156|Device|Standard Polysomnography|
16145017|NCT01820143|Drug|Ilaprazole|
16145018|NCT01820143|Drug|Esomeprazole|
16145019|NCT01820130|Device|St Jude Medical EON mini rechargeable system|implantation of Eon Mini Neurostimulation System (IPG Model 3788)
16145020|NCT01820117|Other|Neurocognitive Evaluation|The neurocognitive evaluation will include measures of academic achievement, intelligence, sustained attention, memory, processing speed, executive functions, functional behavior, and emotional functioning.
16145021|NCT01820117|Other|Quantitative Brain Imaging|Imaging will include raw images to both quantify white matter hyperintensities and hemosiderin deposits, as well as cortical thickness and tissue segmentation. Brain imaging will be repeated on participants who are concurrently enrolled on BRIGHT and MIND protocols at St. Jude and who completed prior brain imaging during the BRIGHT clinic visit. The repeat MRI will be done at their 6 month MIND clinic visit.
16145022|NCT01820117|Other|Neurologic Evaluation|Evaluation includes a complete review of neurologic symptoms, and interview and examination by the neurologist, assessment of neurologic symptoms and determination of their impact on day-to-day living, and quantified neurologic examination by the neurologist.
16145023|NCT01820117|Other|Health Questionnaire|Participants will be asked to complete an approximately 450-item survey to assess health history and status, social and demographic factors, health behaviors, and psychosocial constructs.
16145024|NCT01820117|Other|Vascular Testing|Digital assessment of endothelial function will be studied, and central blood and pulse pressure and carotid-femoral pulse wave velocity will be non-invasively measured.
16145025|NCT01820117|Other|Cardiopulmonary Exercise Testing|Study participants will undergo cardiopulmonary exercise testing by treadmill. Those participants whose physical performance does not permit walking safely on the treadmill (extreme deconditioning, lower extremity paralysis, balance disorder, acute lower extremity injury) will perform cardiopulmonary exercise testing on a bicycle or upper extremity ergometer using a comparable testing protocol.
16145026|NCT01820117|Other|Echocardiography|A complete 3D as well as 2D echocardiogram with Doppler and M-mode will be performed.
16145027|NCT01820117|Other|Pulmonary Function Testing|Pulmonary function testing will include spirometry, lung volume measurements by body plethysmography, and single-breath carbon monoxide-diffusion capacity (DLCO).
16145028|NCT01820117|Procedure|Serum Biomarkers|Blood for serum biomarkers associated with cardiovascular morbidity will be drawn, including high-sensitivity C-reactive protein, serum homocysteine.
16145029|NCT01820117|Other|Ophthalmology Examination|Ophthalmology examination will include a review of symptoms, examination, and fundus imaging. The examination will consist of visual acuity testing, refraction testing, retinoscopy, ocular pressure, and examination under mydriasis. Fundus photography will be used to capture an image of the retina for examination of potential hypertensive retinopathy.
16145030|NCT01820104|Drug|lansoprazole, 30 mg per day for 6 days|
16145031|NCT01820091|Drug|Folotyn|A cycle of Folotyn treatment is 28 days, with treatment on Days 1 and 15 in each cycle.
16145034|NCT01820078|Other|Comparator Arm|Daily treatment is not define by protocol, because daily treatment in CKD is highly variable and includes salt and/or blood pressure regulation, angiotensine system stoppers, controlled diet, etc.
16145035|NCT01820065|Procedure|Cataract surgery with IOL implantation|Phacoemulsification with implantation of single piece Acrysof IOL
16145036|NCT01820052|Drug|Oral Iron|230 mg of elemental oral iron tablets will be administered daily for 3 months
16145037|NCT01820052|Drug|Oral Placebo|Oral tablets matching oral iron will be administered daily for 3 months
16145038|NCT01820039|Other|FertiScreen|FertiScreen is an online application to assess whether referral is necessary or expectant management is indicated.
16145039|NCT01820026|Drug|Imipenem|second line therapy
16145040|NCT01820026|Drug|Vancomycin|Second line therapy
16145041|NCT01820026|Drug|azithromycin|Second line therapy
16145042|NCT01820026|Drug|Cefotaxime|Standard antibiotic therapy
16145043|NCT01820026|Drug|Amoxicillin|Standard therapy
16145044|NCT01820013|Device|Customised Dynamic Elastomeric fabric Orthoses|Eligible participants will be measured and fitted with a customised Dynamic Elastomeric Fabric Orthoses. The participant may require a re-fitting of the garment as they progress through their pregnancy. Participants will also be issued with standardised advice on PGP management via an information leaflet from Association of Chartered Physiotherapists in Women's health website.
16145045|NCT01820013|Device|Serola Sacroiliac Belt|Eligible participants will be measured and fitted with a Serola sacroiliac belt. Participants will also be issued with standardised advice on PGP management via an information leaflet from Association of Chartered Physiotherapists in Women's health website.
16145046|NCT01820000|Procedure|Diffusion Weighted Imaging with MRI scans|Subjects will have an MRI(magnetic resonance imaging)performed. This sequence will take no longer than 10 to 15 minutes to complete. Only DWI (diffusion weighted imaging) will be added to the standard cardiac MR protocol for viability which requires contrast injection. DWI(diffusion weighted imaging) sequence does not require contrast injection.
16145047|NCT01819987|Behavioral|Tablet computer|Participants in the intervention group will receive eight weekly online sessions and interactive activities delivered through tablet computers. Intervention participants will receive instructions for accessing the program via the tablet at an in-person session. Automated weekly emails will be sent to participating mothers for the intervention duration to encourage study engagement.
16145048|NCT01819987|Behavioral|Mailing information|Participants in the control group will receive general health promotion topics relevant to preschool-age children (such as immunization, injury prevention and school readiness) via mailing materials that are bilingual weekly for eight weeks. These materials will be obtained from CDC and AAP.
16145049|NCT01819974|Other|Stratified medication review|A mediciation review will be performed in patients with high medication error rik. Patients in the highest risk will receive the medication review from a clinical pharmacologist whereas patients assessed in lesser risk will receive the medication review from a clinical pharmacist.
16145050|NCT01819961|Drug|MCT/LCT and fish oil|
16145051|NCT01819961|Drug|MCT/LCT|
16145052|NCT01819948|Dietary Supplement|PhytoMed™|
16145053|NCT01819935|Drug|linezolid (Zyvox)|As prescribed-this is retrospective cohort of existing clinical data.
16145054|NCT01819935|Drug|vancomycin|As prescribed-this is retrospective cohort of existing clinical data.
16145055|NCT01819922|Drug|PF-05175157|600 mg as powder in capsule, one dose within 5 minutes prior to AM meal
16145056|NCT01819922|Drug|Placebo|Placebo powder in capsule, one dose within 5 minutes prior to AM meal
16145057|NCT01819909|Procedure|Postoperative Jackins Exercise Protocol|Jackin's exercises were initially designed for patients with difficulty performing forward elevation. The patient initially is positioned supine to perform shoulder flexion. When the patient can actively elevate in the supine position, one to two pounds of weight is placed in the patients hand and the patient is asked to repeat the maneuver of supine active elevation. When the patient can do this with little difficulty, the head of the bed is elevated approximately 20 degrees from the supine position and the sequence is repeated. Once the patient is able to perform flexion in this elevated head position, the inclination of the patient is increased in 20 degree increments until the patient is able to perform upright sitting shoulder flexion.
16145058|NCT01819909|Procedure|Postoperative Pulleys Exercise Protocol|Pulleys have been used in postoperative shoulder rehabilitation to improve passive as well as active range of motion and develop strength.
16145059|NCT01819896|Drug|Pacemaker and defibrillator|
16145060|NCT01819870|Drug|Dilatrend SR capsule 32mg|"1 capsule, oral, once daily, 7days
~over the period I&II(crossover)"
16145061|NCT01819870|Drug|Dilatrend IR tablet 25mg|"1 tablet, oral, once daily, 7days
~over the period I&II(crossover)"
16145062|NCT01819857|Drug|Xomolix 0.625 mg intravenously|intravenous administration of 0.625 mg droperidol
16145063|NCT01819857|Drug|Xomolix 1.25 mg|intravenous administration of 1.25 mg droperidol
16145064|NCT01819857|Drug|Zofran 8 mg|intravenous administration of 8 mg ondansetron
16145065|NCT01819844|Device|Closed-loop blood glucose control|The InPatient Closed Loop Device is made up of the three components; the Abbott FreeStyle Navigator subcutaneous continuous glucose monitor, the Symbiq insulin-dextrose infusion system, and the control algorithm. In this feasibility trial we will study 6 insulin-sensitive subjects with type 1 diabetes and 6 subjects with type 2 diabetes and a high insulin requirement (3 with total daily dose from 1-1.9 u/kg and 3 with total daily dose > 2 u/kg).
16145066|NCT01819831|Radiation|proton radiation|proton radiation: 2 GyE/Day to isocenter, one treatment per day, 5 days per week for 25 treatments (=50 GyE to isocenter/25 fractions)
16145067|NCT01819831|Procedure|surgery (wide local excision; limb preservation surgery)|In areas with ample soft tissue that can be removed without compromising future function or wound closure, wide margins is the goal of treatment; associated rates of local failure are low in such instances. Margins will be determined by the surgeon; the goal is to achieve at least a 2 mm negative margin resection. However, smaller margins can be acceptable if it allows for limb-sparing surgery with conserved functional outcomes. Every effort will be made to have limb preservation surgery unless there is documented evidence of tumor progression during or after the course of radiation that would require amputation for an appropriate margin resection.
16145068|NCT01819818|Drug|No intervention|This is an observational study. Korean schizophrenic participants receiving paliperidone palmitate as an intramuscular injections will be observed.
16145069|NCT01819805|Drug|No intervention|This is an observational study. Patients taking extended release tramadol hydrochloride 75 mg and acetaminophen 650 mg orally twice daily will be observed.
16145070|NCT01819792|Other|Multiplex respiratory viral PCR|
16145071|NCT01819779|Drug|Exforge tab. 10/160mg|
16145072|NCT01819779|Drug|Lodivixx tab. 5/160mg|
16145073|NCT01819753|Procedure|Percutaneous nephrolithotomy|The procedure is done under general anesthesia in the supine position. A Retrograde pyelogram is done to locate the stone in the kidney. With a small incision in the flank, the percutaneous nephrolithotomy (PCN) needle is passed into the pelvis of the kidney. The position of the needle is confirmed by fluoroscopy. A guide wire is passed through the needle into the pelvis. The needle is then withdrawn with the guide wire still inside the pelvis. Over the guide wire the dilators are passed and a working sheath is introduced. A nephroscope is then passed inside and stones are taken out.
16145074|NCT01819740|Other|"determine the levels of the HEM substance in seminal plasma"|
16145075|NCT01819727|Drug|BMN 165|After informed consent, eligible subjects will be randomized (1:1) to titrate up to one of two dose regimens: 20 mg/day or 40 mg/day. All subjects will initiate IP at a fixed-dose of 2.5 mg/week for 4 weeks (Induction). After the Induction Period, subjects will enter the Titration Period (Weeks 5 up to 34) where they will increase their weekly BMN 165 dose to a daily dose regimen of 20 mg/day or 40 mg/day. The Titration Period will be individualized to each subject based on a minimum of 6 weeks (the amount of time it takes to reach a dose regimen of 20 mg/day with no dose interruptions) and up to 30 weeks (accounts for dose reduction or interruption due to AEs). Subjects will stop titration once they have achieved either the 20 mg/day or 40 mg/day dose regimen. The majority of subjects will maintain the 20 or 40 mg/day dose regimen for at least an additional 2 weeks until a minimum of approximately 26 weeks or a maximum of 36 weeks in the study.
16145076|NCT01819714|Other|Multi-sensory supportive care|"The Serre-Cavalier center will implement Snoezelen-type multisensory care sessions for included patients; these care sessions correspond with the patients' daily hygiene/toilette care.
~The impact of this multisensory strategy will be evaluated using a before-after design."
16145077|NCT01819701|Dietary Supplement|LC-1000|L-carnitine 1000 mg /d
16145078|NCT01819701|Dietary Supplement|LC-2000|L-carnitine: 2000 mg/d
16145079|NCT01819701|Dietary Supplement|Q10-150|Coenzyme Q10: 150 mg/d
16145080|NCT01819701|Dietary Supplement|Q10-300|Coenzyme Q10: 300 mg/d
16145081|NCT01819701|Other|Placebo|
16145082|NCT01819688|Procedure|laparoscopic liver resection|
16145083|NCT01819675|Device|Low frequency rTMS|
16145084|NCT01819675|Device|High frequency rTMS|
16145085|NCT01819675|Device|Sham rTMS|
16145086|NCT01819662|Other|Enhanced standard management|Echocardiogram followed by letter to GP about results.
16145087|NCT01819662|Other|Optimised heart failure management|Echocardiogram followed by referral to comprehensive heart failure service for those with left ventricular dysfunction
16145088|NCT01819662|Other|Standard management|Usual care
16145089|NCT01819649|Dietary Supplement|SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S|
16145090|NCT01819636|Other|sparkling highly mineral bicarbonated sodium water|1,25 liter a day at the mealtimes
16145091|NCT01819623|Other|Non-pharmacological therapy|It consists of a weekly two-hour session. During the first hour yoga classes will taught by teacher, during second hour supervised cognitive training by a psychologist based on Memory Program designed by Memory Unit of Madrid
16145092|NCT01819610|Drug|SPRIX|
16145093|NCT01819597|Procedure|Encephaloduroarteriosynangiosis (EDAS)|The operation is a form of indirect revascularization or EC-IC bypass, performed under general endotracheal anesthesia, with intraoperative electroencephalographic monitoring. The surgery consists in the dissection and relocation of the superficial temporal artery (STA) and middle meningeal artery (MMA) branches, which are separated from their surrounding tissues under microscopic visualization and re-routed through a craniotomy to be placed intracranially in close proximity to the branches of the middle cerebral artery (MCA). The MCA branches are dissected in the arachnoid space and the STA and MMA are kept in position with microsutures to the arachnoid or MMA dural cuffs, maintaining close contact between the EC and MCA branches.
16145094|NCT01819571|Drug|Fluid loading (Voluven)|HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 8ml / kg loading during 15 minutes after induction of anesthesia on both groups
16145095|NCT01819558|Biological|recwt1-A10+AS01B|
16145096|NCT01819532|Procedure|Milking group|"The umbilical cord will be milked toward the neonate four times prior to clamping the umbilical cord."
16145097|NCT01819532|Procedure|Immediate cord clamping|The umbilical cord will be clamped and cut immediately after delivery of the neonate.
16145098|NCT01819519|Behavioral|Educational Intervention|The patient will told if previously infected or seronegative and what is the risk of the becoming infected. The research assistant will deliver a 5-10 minutes educational intervention, which will consist of a CMV video and some Q&A.
16145099|NCT01819506|Behavioral|Task Practice Physical Rehabilitation Therapy|Similar to stroke rehabilitation occupational therapy.
16145100|NCT01819493|Behavioral|Lifestyle Intervention|Family-based group lifestyle intervention
16145101|NCT01819493|Behavioral|Standard Family-Based intervention|Comparison intervention
16145102|NCT01819480|Procedure|Transoral robotic surgery|Transoral robotic surgery using the daVinci robot to remove primary tumor
16145103|NCT01819467|Device|Seprafilm|Seprafilm will be placed onto the uterine incision and the anterior midline of the uterus following the primary cesarean section
16145104|NCT01819454|Device|pH monitoring (Restech)|"see in detail description of the study part of the protocol"
16145105|NCT01819441|Drug|Azelnidipine|8mg or 16mg
16145106|NCT01819441|Drug|Perindopril|4mg or 8mg
16145107|NCT01819441|Drug|hydrochlorothiazide|12.5mg or 25mg
16145108|NCT01819428|Drug|NOV120101 (Poziotinib)|NOV120101 (Poziotinib)12 mg PO once daily until disease progression or unacceptable toxicity development
16145109|NCT01819415|Dietary Supplement|Anti-VEGF plus AREDS-2|Omega-3 metabolites supplementation
16145110|NCT01819415|Dietary Supplement|Anti-VEGF plus AREDS-1|Patients receiving intravitreal anti-VEGF and AREDS-1 supplementation plus Lutein, without Omega-3.
16145111|NCT01819402|Drug|Pioglitazone vs Glimepiride|
16145112|NCT01819389|Drug|Imatinib and Nilotinib|
16145113|NCT01819376|Other|Facebook Status Update|
16145114|NCT01819363|Procedure|Pleural elastance|The pleural pressure level will be zero at the time of the insertion site of the drain on the skin. The pleural pressure is set to the value measured at end-expiration. The pleural pressure is measured at baseline, after withdrawal of 10 ml of liquid and thereafter every 400 ml of pleural effusion evacuated to the pressure to be negative, from that moment the measurement will occur every 200 ml of pleural effusion drained to obtain 800 ml of liquid. Patients that are removed less than 800 ml of liquid will be excluded from the protocol. The pleural elastance is then calculated in cm H2O / L and the data placed in a pressure curve by volume.
16145115|NCT01819350|Other|G1, G2 and G3|Nutritional, respiratory and endocrine group applicated 12 subjects
16145116|NCT01819350|Other|G4 and G5|Application of trhree pediadic medidines of antibiotic group on dental biofilm 12 subjects
16145117|NCT01819324|Behavioral|Targeting the Teachable Moment|TTMI material (every other week for 4 months)
16145118|NCT01819324|Behavioral|Standardized Lifestyle Management|SLM material (every other week for 4 months)
16145119|NCT01819311|Behavioral|Attention Bias Modification|At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe always replaces the neutral stimulus and never replaces the threatening stimulus. The intervention is based on the idea that attention can be shaped via repetitive computer based training methods, and training attention toward neutral stimuli will lead to a reduction in anxiety and its disorders.
16145120|NCT01819311|Behavioral|Placebo Attention Task|At each of eight sessions, participants complete 160 computer administered trials wherein a pair of threatening stimuli and neutral stimuli is presented simultaneously and then followed immediately by a probe. The probe replaces the neutral stimulus and the threatening stimulus with equal probability.
16145121|NCT01819285|Procedure|Immediate Orchiectomy or depot LHRH|
16145122|NCT01819285|Procedure|Delayed Orchiectomy or depot LHRH|
16145123|NCT01819272|Drug|Met DR|metformin delayed-release tablets
16145124|NCT01819272|Drug|Met XR|metformin extended-release tablets
16145125|NCT01819272|Drug|Placebo|placebo delayed-release tablets
16145126|NCT01819259|Drug|Nicotine nasal spray|This study will use nicotine nasal spray to safely and effectively model the effects of initial smoking experiences in nonsmokers. Neither the safety nor the effectiveness of this drug will be assessed. The overall goal of the proposed research is to evaluate the behavioral and genetic mechanisms of smoking risk in non-smoking young adults (aged 18-25 years of age) with and without ADHD using a novel laboratory-based model of intranasal nicotine administration. The effects of two doses of intranasally administered nicotine versus placebo will be assessed. In addition, nicotine self-administration will be evaluated under conditions that are likely to be more cognitively challenging among individuals with ADHD.
16145127|NCT01819259|Drug|Placebo|
16145128|NCT01819246|Procedure|Aphersis Treatment Arm|
16145129|NCT01819246|Other|Control Arm|
16145130|NCT01819233|Behavioral|Behavioral dietary intervention|Receive caloric restricted dietary intervention
16145131|NCT01819233|Procedure|Therapeutic conventional surgery|Undergo definitive lumpectomy
16145132|NCT01819233|Radiation|Radiation therapy|Undergo radiation therapy
16145133|NCT01819233|Other|Counseling intervention|Receive dietary counseling
16145134|NCT01819233|Procedure|Quality-of-life assessment|Ancillary studies
16145135|NCT01819220|Drug|amlodipine/valsartan|"This is a phase IV clinical study. The study is a 24 week, prospective, randomized open labeled multicenter study to compare the efficacy of amlodipine/valsartan combination vs telmisartan/hydrochlorothiazide combination in reducing post prandial sugar. The study will be performed in hypertensive patients with metabolic syndrome.
~Active group: Starting dose of amlodipine 5mg/ valsartan 80mg comparator group: Telmisartan 40mg/hydrochlorothiazide 12.5mg When the blood pressure is above the target goal of 140/90mmHg, up titration to amlodipine 5/valsartan 160 and/or telmisartan 80/hydrochlorothiazide 12.5mg is allowed.
~When the blood pressure is above 140/90mmhg at the 12th week, addition of doxazosin 4mg is allowed."
16145136|NCT01819220|Drug|hydrochlorothiazide/telmisartan|"When the blood pressure is above the target goal of 140/90mmHg, uptitration to amlodipine 5/valsartan 160 and/or telmisartan 80/hydrochlorothiazide 12.5mg is allowed.
~When the blood pressure is above 140/90mmhg at the 12th week, addition of doxazosin 4mg is allowed."
16145137|NCT01819207|Other|blood test by thromboelastography|
16145138|NCT01819194|Device|senofilcon A|
16145139|NCT01819155|Biological|Adjuvanted seasonal trivalent inactivated influenza vaccine|
16145140|NCT01819155|Biological|Seasonal trivalent inactivated influenza vaccine|
16145141|NCT01819155|Biological|Saline (bacteriostatic 0.9% sodium chloride for injection)|
16145142|NCT01819142|Device|AutoloGel|AutoloGel is a platelet-rich plasma (PRP) gel used in the treatment of non-healing chronic wounds. It will be administered twice weekly for 2 weeks then weekly.
16145143|NCT01819129|Drug|Faster-acting insulin aspart|Mealtime FIAsp administered subcutaneously (s.c., under the skin). Dose individually adjusted.
16145144|NCT01819129|Drug|Insulin aspart|Mealtime insulin aspart administered subcutaneously (s.c., under the skin). Dose individually adjusted.
16145145|NCT01819129|Drug|Insulin glargine|Administered s.c. once daily at subjects' pre-trial dose. Subjects will continue their metformin treatment without changing the frequency or dose throughout the trial.
16145146|NCT01819090|Device|Elysee 150 ventilator|
16145147|NCT01819090|Device|Elysee 150 ventilator with a ventilation switch control|
16145148|NCT01819077|Procedure|TMMR|Radical hysterectomy by Total Mesometrial Resection (TMMR) and therapeutic lymphadenectomy (tLNE)
16145149|NCT01819064|Drug|Atropine|intravenous atropine in low doses does not cause bradycardia
16145150|NCT01819064|Drug|Atropine|IV dose at 5 mcg/kg
16145151|NCT01819051|Device|MOE Antimicrobial Plasma Treatment System|Plasma applied to great toenail 1X/week for three weeks
16145152|NCT01819038|Procedure|continuous renal replacement therapy|
16145153|NCT01819025|Behavioral|4 face-to-face therapy session and a smartphone-app|An 8 week blended therapy with both face-to-face therapy sessions and support through a smartphone application.
16145154|NCT01819025|Behavioral|CBT, treatment as usual|10 sessions of face-to-face therapy, full behavioral activation
16145155|NCT01819012|Drug|Isoflurane 1.0 MAC|10 min-inhalation of each concentration of isoflurane, 1.0 MAC
16145157|NCT01819012|Drug|Isoflurane 2.0 MAC|10 min-inhalation of each concentration of isoflurane, 2.0 MAC
16145158|NCT01818999|Drug|IXABEPILONE|injection
16145159|NCT01818999|Radiation|STEREOTACTIC BODY RADIATION THERAPY|SBRT will begin between 1 and 5 weeks after the initiation of Ixabepilone. Patients will receive one, three, or five fractions.
16145160|NCT01818986|Drug|Sipuleucel-T|
16145161|NCT01818986|Radiation|Stereotactic Ablative Body Radiation|
16145162|NCT01818973|Drug|Xeloda|po, 1000mg/m2/12h daily, day 1 in the afternoon until day 15 in the morning, 8 cycles
16145163|NCT01818973|Drug|Oxaliplatin|iv, 130mg/m2, day 1, 1 cycle during neoadjuvant chemotherapy and 3 cycles in adjuvant chemotherapy 100mg/m2, day 1, 2 cycles during concurrent chemoradiotherapy
16145164|NCT01818973|Drug|Bevacizumab|iv, 7.5 mg/kg, day 1, 3 cycles during neoadjuvant chemotherapy and concurrent chemoradiotherapy
16145165|NCT01818973|Radiation|Radiation|Intensity-modulated radiation therapy, 50 Gy/25 fractions during 5 weeks
16145166|NCT01818973|Procedure|surgery|Total Mesorectal Excision (TME)
16145167|NCT01818960|Procedure|IRA-PCI|IRA only PCI at the time of Primary PCI
16145168|NCT01818960|Procedure|SS-PCI|Same sitting multivessel PCI as an adjunct to primary PCI
16145169|NCT01818934|Procedure|hip ultrasound|Standardized single-examiner Hip ultrasound was offered to all babies in the universal group, babies at increased risk in the selective group, and to no babies in the clinical exam only group
16145170|NCT01818921|Drug|ZGN-440 sterile diluent|ZGN-440 sterile diluent/placebo
16145171|NCT01818921|Drug|1.2 mg ZGN-440 for injectable suspension|1.2 mg beloranib
16145172|NCT01818921|Drug|1.8 mg ZGN-440 for injectable suspension|1.8 mg beloranib
16145173|NCT01818908|Drug|DA-EPOCH|DA-EPOCH regimen
16145174|NCT01818882|Other|Standard care|Standard care for dyspneic patients including contextual analysis, conventional clinical exam and a chest X-Ray.
16145175|NCT01818882|Device|Vscan portable ultrasound device (GE Healthcare, Wauwatosa, WI)|Standard care (as described for the other intervention) + pleuropulmonary ultrasound using the Vscan portable ultrasound device (GE Healthcare, Wauwatosa, WI).
16145176|NCT01818869|Drug|AZD8848|Multiple doses inhaled IMP via a nebulizer
16145177|NCT01818869|Drug|Placebo to match AZD8848|Multiple doses inhaled matching placebo via a nebulizer
16145178|NCT01818856|Drug|Ritonavir withdrawal, atazanavir 200 mg/12h|
16145179|NCT01818856|Drug|Telaprevir interactions|
16145180|NCT01818843|Other|Inhaled Carbon Monoxide|Inhaled Carbon Monoxide in newborn
16145181|NCT01818804|Dietary Supplement|n-3PUFA|
16145182|NCT01818804|Dietary Supplement|olive oil|
16145183|NCT01818791|Behavioral|Making Proud Choices|Making Proud Choices (MPC) is a well-established pregnancy and HIV/STI risk-reduction EBP with multiple trials demonstrating its effectiveness. Using Social Cognitive Theory, the Theories of Reasoned Action, and Planned Behavior, MPC aims to influence adolescents' knowledge and beliefs about risk, efficacy, and control to change behavior. MPC stresses the role of sexual responsibility, community, and pride in making safer sexual choices. The program promotes abstinence first, but also provides information and skills needed for safer-sex decision-making and practices (e.g., condom use).
16145184|NCT01818791|Behavioral|Making Proud Choices AND Getting To Outcomes|"In addition to MPC, these sites receive the Getting To Outcomes(GTO) intervention, which builds capacity for EBPs by strengthening the knowledge, attitudes, and skills needed to choose, plan, implement, evaluate, and sustain those EBPs. GTO poses ten steps that must be addressed and provides practitioners with the guidance necessary to address those steps with quality-i.e., as close to the ideal as possible. Implementation of these ten steps is facilitated by three types of assistance: the GTO manual of text and tools originally published by the RAND Corporation and then applied to teen pregnancy (PSBA-GTO), face-to-face training, and onsite TA. Consistent with social cognitive theories of behavioral change exposure to GTO training and TA leads to more knowledge about performing GTO-related activities, which leads to more positive attitudes towards these activities, which in turn leads to the execution of more GTO-related behaviors."
16145185|NCT01818778|Other|Cognitive stimulation program|The stimulation program was composed of therapy- and education-based exercises which were specifically designed to stimulate reasoning, memory, and attention skills in adults.
16145186|NCT01818778|Other|Standard Friendly Visit|"Volunteers provided standard friendly visits to residents which included a friendly greeting and casual conversation about issues which interest the resident."
16145187|NCT01818765|Procedure|Trans-ventricular-septal placement of LV pacing lead|
16145188|NCT01818765|Other|Pre-procedure speckle-tracking echocardiography|Assessment of site of latest mechanical activation
16145189|NCT01818765|Other|Acute response assessment|Cardiac output monitoring
16145190|NCT01818752|Drug|Carfilzomib|Carfilzomib was administered over 30 minutes on days 1, 2, 8, 9, 22, 23, 29, and 30 for nine 42-day cycles. Carfilzomib 20 mg/m² IV was administered on days 1 and 2 of cycle 1, followed by escalation to 36 mg/m² IV starting on day 8 of cycle 1.
16145191|NCT01818752|Drug|Bortezomib|Bortezomib 1.3 mg/m² was administered as a bolus IV injection or as a subcutaneous injection (per investigator's choice, dose modification, or regulatory approval) on days 1, 4, 8, 11, 22, 25, 29, and 32 of cycles 1 to 4, and on days 1, 8, 22, and 29 of cycles 5 to 9.
16145192|NCT01818752|Drug|Melphalan|Melphalan 9 mg/m² was taken orally on days 1 to 4 of all cycles.
16145193|NCT01818752|Drug|Prednisone|Prednisone 60 mg/m² was taken orally on days 1 to 4 of all cycles.
16145194|NCT01818739|Procedure|sentinel lymph node detection|Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue
16145195|NCT01818739|Drug|indocyanine green solution|Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue
16145196|NCT01818739|Drug|isosulfan blue|Undergo sentinel lymph node detection using fluorescence imaging with indocyanine green solution and isosulfan blue
16145197|NCT01818739|Procedure|sentinel lymph node biopsy|Undergo sentinel lymph node biopsy
16145198|NCT01818726|Drug|ICL670|ICL670 was supplied in registered packages as 250mg or 500mg dispersible tablets.
16145199|NCT01818726|Drug|Chelation|Main group of patients with aplastic anemia and transfusion-dependent iron overload underwent treatment programs of standard immunosuppressive treatment (immunosupressant - Cyclosporine A) and received chelation with ICL670 (deferasirox).
16145200|NCT01818726|Drug|No chelation|Comparative group of patients with aplastic anemia and transfusion-dependent iron overload underwent treatment programs of standard immunosuppressive treatment ( immunosupressant -Cyclosporine A)
16145201|NCT01818713|Drug|2B3-101|50 mg/m2 2B3-101 intravenous 3-weekly administration
16145202|NCT01818700|Drug|Buprenorphine|8weeks treatment with Norspan®(Buprenorphine)
16145203|NCT01818687|Drug|colestilan|body surface area equivalent (BSAeq) 3 g/day, 6 g/day, 9 g/day, 12 g/day or 15 g/day
16145204|NCT01818674|Behavioral|Microclinic Behavioral Health Full Program (education curriculum in classroom setting, plus full social interaction program)|A 6-month intervention program (sessions and educational materials) aims to increase knowledge and skills in diabetes self-management and peer support and monitoring. The curriculum include causes of diabetes, prevention of complications, symptoms, self-management strategies, diet, exercise, peer monitoring and support by trained Project nurses from MoH health centers, local physicians, and university professors. Each class will provide 2-3 hours of discussion to foster active class participation and engagement.
16145205|NCT01818674|Behavioral|Microclinic Behavioral Health Basic Program (education-only in classroom setting; no structured social interactions)|This basic program (6 month) aims to increase participants knowledge about diabetes self-management, but without structured social interaction programming. While group classroom setting is still used for delivery of the educational curriculum, the education program in group B have no group-based or team-building activities, group goal setting, and classroom program is lecture style with more limited class participation and interaction.
16145206|NCT01818661|Drug|AV-1451|This is used to assess Tau burden in the brain.
16145207|NCT01818648|Drug|Exenatide|Qualifying participants will be assigned to 2 different treatment arms consisting of placebo or exenatide 5 mcg administered subcutaneously twice: the first dose during fasting and the second four hours later. Subsequently, participants will switch over to the alternate treatment arm. In both arms participants will undergo a series of measurements including 24 hour GI transit, permeability measurements by using mannitol and lactulose, and 24 hour urine and stool collections.
16145208|NCT01818648|Drug|Placebo|Qualifying participants will be assigned to 2 different treatment arms consisting of placebo or exenatide 5 mcg administered subcutaneously twice: the first dose during fasting and the second four hours later. Subsequently, participants will switch over to the alternate treatment arm. In both arms participants will undergo a series of measurements including 24 hour GI transit, permeability measurements by using mannitol and lactulose, and 24 hour urine and stool collections.
16145209|NCT01818622|Device|Blue-blocking goggles/screens|Goggles with amber tinted lenses, all model's transmittance spectra are identical. Goggles and screens are tested at Department of Physics and Technology, University of Bergen. Patients and non-bipolar controls choose model for best comfort.
16145210|NCT01818622|Device|Clear-lensed goggles|Clear lensed safety eyewear. Patients may choose model for best comfort.
16145211|NCT01818609|Behavioral|Step reduction|taking less than 1500 steps/d
16145212|NCT01818596|Drug|E/C/F/TAF|E/C/F/TAF (150/150/200/10 mg) FDC tablet administered orally once daily with food
16145213|NCT01818583|Drug|Potassium chloride|
16145214|NCT01818583|Drug|Glucose 50 MG/ML|
16145215|NCT01818570|Drug|PPC-5650|A dose of 2.5 mg PPC-5650 in a 100 ml solution will be administered to the esophagus with an infusion rate of 7ml/min in one out of three visit days.
16145216|NCT01818570|Drug|Placebo|A 100 ml placebo solution will be administered to the esophagus with an infusion rate of 7ml/min in one out of three visit days.
16145217|NCT01818557|Behavioral|Blood glucose testing|Patients will be assigned either to blood glucose monitoring done every day (during a fasting state and 2 hours after breakfast, lunch and dinner) continued throughout gestation or to blood glucose monitoring done every other day with the same timeframes outlined above.
16145218|NCT01818544|Drug|BAY85-8501|BAY85-8501 (1.0 mg, 2 tablets each 0.5 mg) will be administered orally once daily in the morning
16145219|NCT01818544|Drug|Placebo|Placebo (1.0 mg, 2 tablets each 0.5 mg) will be administered orally once daily in the morning
16145220|NCT01818531|Drug|Adductor canal block|
16145221|NCT01818531|Drug|Lumbar plexus block|
16145222|NCT01818492|Biological|NI-0501|
16145223|NCT01818479|Biological|stem cell transplant|Open label, dose finding trial with two treatment regimens, Busulfan and Total Body Irradiation (TBI) with four dose escalation cohorts, to assess the efficacy of Treg/Tcon addback to partially matched related donor stem cells.
16145224|NCT01818479|Procedure|Stem cell transplant|
16145225|NCT01818453|Behavioral|Computerized self-help program for depression|For 8 weeks, participants will engage in a computerized self-help program for depression, called deprexis. This program consists of 10 content modules representing different psychotherapeutic approaches broadly consistent with a cognitive-behavioral perspective. Modules are organized as simulated dialogues in which the program explains and illustrates concepts and techniques, engages the user in exercises, and continuously asks users to respond by selecting from response options. Subsequent content is then tailored to the users' responses, resulting in a simulated conversational flow. Participants can access the self-help program as often as they would like and since it is self-guided, they will determine how often they access the material. Each module can be completed in 10 to 60 minutes, depending on the user's reading speed, interest, motivation, and individual path through the program.
16145226|NCT01818440|Other|3D Roadmap software|Two scanning methods will be used by doctors to position catheters in the blood vessels to deliver the chemotherapy and close the blood supply to the tumor.
16145227|NCT01818440|Other|Fluoroscopy|Patients will have the procedure performed with regular fluoroscopy (X-ray). Regular fluoroscopy is the standard method.
16145228|NCT01818427|Biological|infusion of 2 units of plasma|infusion of 2 units of plasma
16145229|NCT01818414|Drug|Misoprostol|400 mcg of buccal misoprostol, 3 hours prior to planned D&E
16145230|NCT01818414|Drug|Folic Acid|4 mg of buccal folic acid, 3 hours prior to planned D&E
16145231|NCT01818401|Device|the prosthesis GMK ® without the ancillary MyKnee ® LBS|
16145232|NCT01818401|Device|Matched patient cutting blocks MyKnee ® LBS|
16145233|NCT01818388|Device|ZOLL Intravascular Temperature Management System (IVTM)|Induced therapeutic hypothermia post cardiac arrest.
16145234|NCT01818375|Procedure|Goal Directed Fluid Therapy (GDFT)-Esophageal doppler guided|
16145235|NCT01818375|Other|Standard fluid therapy|
16145236|NCT01818362|Biological|MVA NP+M1|MVA NP+M1 1.5 x 10⁸pfu intramuscularly.
16145237|NCT01818362|Biological|ChAdOx1 NP+M1|ChAdOx1 NP+M1 2.5 x 10¹⁰vp intramuscularly.
16145238|NCT01818349|Other|isokinetic lower-limb training|concentric training of the affected plantarflexors, hip flexors and hip extensors
16145239|NCT01818349|Other|isokinetic upper-limb training|concentric training of the affected wrist extensors, elbow flexors and shoulder flexors
16145240|NCT01818336|Drug|Penicillin skin test kit|Allergy skin testing is done by puncture and intradermal. If all tests negative, subjects receive an oral amoxicillin challenge.
16145241|NCT01818323|Other|Intra-tumoral T4 immunotherapy|Intra-tumoral administration of a single dose of T4-positive patient-derived T-cells (at five escalating dose levels) contained within 1-4 mL. Cohort 6 patients receive CAR T-cells (dose level 3) after lymphodepletion with fludarabine and cyclophosphamide
16145242|NCT01818310|Biological|Group A: Intramuscular|"Intramuscular BMAC application The study subjects in the Group A will receive a treatment of 35ml BMAC administered intramuscularly into the affected limb, in individual punctures of 1 ml.
~The punctures will be applied into the crural muscle around the defect, the procedure takes approx. 60 minutes."
16145243|NCT01818310|Biological|Group B: Intraarterial|Intraarterial BMAC application The study subjects in the Group B will receive a treatment of 35ml BMAC administered intraarterially into the affected limb.
16145244|NCT01818310|Biological|Group C: Intravenous|Group C: Intravenous The study subjects in the Group C will receive a treatment of 35ml BMAC administered intravenously into the affected limb.
16145245|NCT01818310|Procedure|Group D: Surgical endovascular treatment with maximum medicamentous treatment|Group D: Control Group Control Group - no experimental intervention, standard endovascular treatment or bypass surgery or maximum medicamentous treatment
16145246|NCT01818297|Device|PrimeAdvanced® neurostimulator system|Neurostimulator and associated components
16145247|NCT01818284|Drug|Filgrastim|5 µg/kg in the morning daily for 4 days.
16145248|NCT01818284|Drug|Plerixafor|240 µg/kg subcutaneously in the evening on the fourth day of Filgrastim mobilization.
16145249|NCT01818284|Procedure|Apheresis Procedure|"The apheresis procedure will start in the morning of day 5, approximately 10 to 11 hours after the administration of Plerixafor.
~The apheresis procedure may continue beyond day 1 until the target dose of 4x106 CD34+ cells/kg (recipient's weight) is obtained."
16145250|NCT01818271|Behavioral|conventional physical therapy|will receive a conventional out-patient program which will include: lower extremity stretching and strengthening exercise; fitness using cycle ergometer; balance exercises in standing; over ground walking and stair exercises
16145251|NCT01818271|Behavioral|community-based group rehabilitation|"Group training will include different workstations to target dynamic standing balance and walking. The key features includes facilitate repetition of task-related movements, tailored to the patient and patient's goals, in a meaningful context. Specifically:
~Advanced dynamic tasks, including stepping and other transitional tasks to treadmill & over ground walking) with use of various inexpensive exercise assistive equipment such as mini-exercise stepper or elliptical machines.
~Treadmill walking exercise program."
16145252|NCT01818258|Drug|ZDV+3TC+LPV/r|
16145253|NCT01818245|Drug|LY2605541|
16145254|NCT01818232|Drug|[14C]-LX4211|
16145255|NCT01818219|Procedure|Records of EADI derived parameters|
16145256|NCT01818206|Other|Collection of induced sputum in order to evaluate the efficacy of a cocktail of 10 bacteriophages.|Collection of induced sputum on cystic fibrosis patients in order to evaluate the efficacy of a cocktail of 10 bacteriophages.
16145257|NCT01818180|Dietary Supplement|URELL|
16145258|NCT01818180|Other|Placebo|
16145259|NCT01818167|Drug|10% Benzoyl Peroxide Topical Body Wash|
16145260|NCT01818167|Drug|Provodine Topical Cream|
16145261|NCT01818154|Other|LED phototherapy|
16145262|NCT01818154|Other|narrowband UVB phototherapy|
16145263|NCT01818141|Drug|Vancomycin|Vancomycin 125mg by mouth every 6 hours for 10 days
16145264|NCT01818141|Drug|Fidaxomicin|Fidaxomicin 200mg by mouth every 12 hours for 10 days
16145265|NCT01818128|Device|Neutral shape of bronchial tip|Intubation is performed without transforming the shape of the bonchial tipof a double lumen tube.
16145266|NCT01818128|Device|Bent shape of bronchial tip|Intubation is performed with the double lumen tube, which bronchial tip has been bent 45 degrees and maintained for 5 min.
16145267|NCT01818115|Device|Hydrus Implant|
16145268|NCT01818115|Procedure|IOL placement|
16145269|NCT01818102|Device|Width 1000 HU/Level -450 HU|Double-lumen tube size is selected according to the internal diameter of the left mainstem bronchus measured in the chest computed tomography with width 1000 HU and level -450 HU.
16145270|NCT01818102|Device|Width 400 HU/Level 25 HU|Double-lumen tube size is selected according to the internal diameter of the left mainstem bronchus measured in the chest computed tomography with width 400 HU and level 25 HU.
16145271|NCT01818089|Device|Lung sound analyzer|Patients will be aucultated with lung sound analyzer. The auscultation will be done three times daily during the duration of the complete hospital stay.
16145272|NCT01818076|Drug|Botulinum Toxin Type A|Botulinum toxin type A, Dose A applied to the lateral canthal area
16145273|NCT01818063|Drug|Paclitaxel|Given IV
16145274|NCT01818063|Drug|Carboplatin|Given IV
16145275|NCT01818063|Drug|Doxorubicin|Given IV
16145276|NCT01818063|Drug|Cyclophosphamide|Given IV
16145277|NCT01818063|Drug|Veliparib|Given PO
16145278|NCT01818050|Other|Liver Function Tests|LFTs will be checked periodically after Wing stent placement to evaluate stent patency
16145279|NCT01818037|Procedure|Cataract surgery|
16145280|NCT01818024|Drug|Single IV dose of GSK2862277|GSK2862277 solution available in a 40 mg vial for IV administration.
16145281|NCT01818024|Drug|Matching placebo single dose IV infusion|Matching placebo solution available for IV administration.
16145282|NCT01818024|Drug|Single IH dose of GSK2862277|GSK2862277 nebulised solution available in a 40 mg vial for IH administration.
16145283|NCT01818024|Drug|Matching placebo single dose IH|Matching placebo nebulised solution available for IH administration.
16145284|NCT01818024|Drug|Repeat IV dose of GSK2862277|GSK2862277 solution available in a 40 mg vial for IV administration.
16145285|NCT01818024|Drug|Matching placebo repeat dose IV infusion|Matching placebo solution available for IV administration.
16145286|NCT01818024|Drug|Repeat IH dose selected of GSK2862277 from Part 2|GSK2862277 nebulised solution available in a 40 mg vial for IH administration.
16145287|NCT01818024|Drug|Matching placebo repeat dose IH|Matching placebo nebulised solution available for IH administration.
16145288|NCT01818011|Drug|GSK1322322 Initial fit for purpose tablets|Beige, capsule shaped, film-coated tablet with unit dose strength of 500 mg/tablet and dose level of 1500 mg (3 x 500 mg) for single dose oral administration in Part A
16145289|NCT01818011|Drug|GSK1322322 over granulated tablets|Light beige, oval shaped, film-coated tablet with unit dose strength of 500 mg/tablet and dose level of 1500 mg (3 x 500 mg) for single dose oral administration in Part A
16145290|NCT01818011|Drug|GSK1322322 intended commercial tablets|Light beige, oval shaped, film-coated tablet with unit dose strength of 500 mg/tablet and dose level of 1000 mg (2 x 500),1500 mg (3 x 500 mg) and 2000 mg (4 x 500mg) for single dose oral administration in Part A and B and repeat dose administration twice daily in Part C
16145291|NCT01818011|Drug|Placebo tablets|Light beige, oval-shaped, film-coated tablet for repeat dose oral administration (BID for 6 days) in Part C
16145292|NCT01818011|Drug|13C-GSK1322322 stable isotope powder|White to slightly colored non-sterile crystalline powder for oral suspension with dose level of 50 mg as a single dose with GSK1322322 tablets in Part A
16145293|NCT01818011|Drug|GSK1322322 for injection|White to slightly colored lyophilized powder cake in clear glass vials with unit dose strength of 400 mg/vial and dose levels of 600 mg (1.5 x 400 mg/vial), 900 mg (2.25x400mg/vial), 1200 mg (3x400mg/vial and 1200 mg (3 x 400 mg) for IV administration either as single dose in Part B or as a repeat dose (BID for 4 days) in Part C
16145294|NCT01818011|Drug|Placebo injection|A clear and colorless 0.9% Sodium Chloride solution for intravenous administration twice daily for 4 days in Part C
16145295|NCT01817998|Other|Physical Exercise|Comparison of high versus low intensity physical exercise in patients with atrial fibrillation.
16145296|NCT01817985|Drug|GS-5816|
16145297|NCT01817972|Biological|Certolizumab pegol|Subcutaneous injection
16145298|NCT01817972|Drug|Azathioprine|50mg tablets
16145299|NCT01817959|Drug|Reparixin|Continuous i.v. infusion into a central vein for 7 days, starting approximately 12 hrs (6-18 hrs) before each pancreatic islet infusion.The Investigational Product (IP) were to be administered as an add-on treatment for the immunosuppressant regimen.
16145300|NCT01817959|Drug|Placebo|Continuous infusion at a volume/rate matching active treatment.The placebo was to be administered as well as an add-on treatment for the immunosuppressant regimen.
16145301|NCT01817946|Other|Genetic Testing|Genetic testing services will be provided by the University of Chicago under the guidance of Dr. Soma Das, PhD. Services will be coordinated by Rachel Alvarez, CMDIR Associate Director. Genetic testing will include standard sequencing of the MTM1 gene followed by CGH array for deletion/duplication in cases where no pathologic variant is identified by standard sequencing.
16145302|NCT01817933|Behavioral|physical therapy|
16145303|NCT01817920|Behavioral|integrated multidisciplinary fall prevention program|
16145304|NCT01817907|Drug|Placebo pill|Subjects will receive a sugar pill during the placebo arm
16145305|NCT01817907|Drug|Trazodone|Subjects will receive trazodone during one of their treatment arm studies
16145306|NCT01817894|Drug|Eflornithine cream 11.5 w/w %|Split face intervention with application of Eflornithine cream 11.5 w/w % versus no treatment for six months
16145307|NCT01817868|Other|Recombinant Factor VIII (Kogenate, BAY14-2222)|All dosage, frequency and duration for drugs will be under the decision of the treating physician.
16145308|NCT01817855|Drug|AZD7624|Multiple ascending doses (starting from 300 µg lung deposited dose up to 1200 µg) inhaled IMP via a nebulizer
16145309|NCT01817855|Drug|Placebo to match|Multiple doses inhaled placebo via a nebulizer
16145310|NCT01817842|Behavioral|Mobile EX cessation support|Mobile EX cessation support is designed to enhance the Washington D.C. Quitline (DCQL) by giving participants the ability track their cessation attempt on a phone-based app and thus create a profile documenting their progress and set-backs over the days or weeks in between QL contacts. Participants receive summary information and graphics that help them understand what is working best for them. Participants also receive 24-hr, momentary access to a set of interactive cessation tools on their phone.
16145311|NCT01817842|Behavioral|DC Quitline Support|Participants assigned to standard DC Quitline programming receive 6 proactive QL counseling sessions and optional, free nicotine replacement therapy (NRT).
16145312|NCT01817842|Behavioral|Device Control|Mobile phone for use during cessation attempt but with no mEX support components
16145313|NCT01817829|Drug|paracetamol|500 mg oral tablet
16145314|NCT01817829|Drug|placebo|
16145315|NCT01817816|Procedure|Botox_A|
16145316|NCT01817816|Procedure|Botox_B|
16145317|NCT01817803|Drug|furosemide/no spironolactone|furosemide (doubling previous furosemide dose)
16145318|NCT01817803|Drug|metolazone/no spironolactone|metolazone (add 2.5mg qod)
16145319|NCT01817803|Drug|furosemid/spironolactone|furosemide (doubling previous furosemide dose)+spironolactone (doubling previous spironolactone dose or add 12.5mg BID if previous non-user)
16145320|NCT01817803|Drug|metolazone/spironolactone|metolazone (add 2.5mg qod)+ spironolactone (doubling previous spironolactone dose or add 12.5mg BID if previous non-user)
16145321|NCT01817790|Drug|Fluticasone propionate|Nasal spray formulation (200 mcg/day)
16145322|NCT01817790|Drug|Placebo|Vehicle for Fluticasone propionate aqueous nasal spray
16145323|NCT01817777|Drug|Metformin Small Pack|A single small pack of metformin will consist of a blister package containing 10 pills with a patient information leaflet in local language. The small packs will be available at each site in the following doses: 500 mg, 850 mg, and 1000 mg. The small pack size of metformin is not yet marketed. Small pack metformin will be provided by GSK as GSK brand metformin.
16145324|NCT01817777|Drug|Metformin Large Pack|The large pack will consist of 1 month's supply of metformin.
16145325|NCT01817764|Drug|Umeclidinium/vilanterol|Dry white powder delivered via NDPI (2 strips with 30 blisters each, first containing UMEC 62.5 mcg per blister and second containing VI 25 mcg per blister), administered as one inhalation of UMEC/VI 62.5/25 mcg once-daily in the morning
16145326|NCT01817764|Drug|Fluticasone propionate/salmeterol|Dry white powder delivered via ACCUHALER/DISKUS (1 strip with 60 blisters, containing 250 mcg fluticasone propionate and 50 mcg salmeterol per blister), administered as one inhalation of FSC 250/50 mcg each morning and evening
16145327|NCT01817764|Drug|Placebo|Placebo will be administered via ACCUHALER/DISKUS or NDPI. Dry white powder administered as one inhalation each morning and evening via ACCUHALER/DISKUS (1 strip with 60 blisters containing placebo) OR once-daily in the morning via NDPI (2 strips with 30 blisters each, containing placebo)
16145331|NCT01817738|Biological|CV9104|Intradermal injection of CV9104
16145332|NCT01817738|Biological|Placebo|Intradermal injection of placebo
16145333|NCT01817725|Biological|HBV vaccine (Engerix B)|Engerix-B (20μg/ml, GlaxoSmithKline Biologicals) is administered intramuscularly at 0, 2, 4, 6, 8, 10, 12 months. The dosage will be 20μg in those <= 20 years old and 40μg in those > 20 years old.
16145334|NCT01817712|Behavioral|Individual Placement & Support|"IPS uses an integrated place-train approach to help people obtain and maintain community-based competitive employment in their chosen occupation."
16145335|NCT01817712|Behavioral|VA Transitional Work Program|"The long-standing approach to vocational rehabilitation in VHA and state programs is the train-place or stepwise model that is founded on the assumption that the patient or client benefits from some form of pre-vocational training, instruction, or practice in a protected, but artificial, work setting prior to entering or being placed in a competitive work role."
16145336|NCT01817699|Other|High Hb target|"25 to 250 μg of methoxy polyethylene glycol epoetin beta (Mircera®, Chugai pharmaceutical Co. Ltd.) will be administered subcutaneously at 2- to 6-week interval.
~Dose and interval will be adjusted according to hemoglobin level and its target."
16145337|NCT01817699|Dietary Supplement|cholecalciferol|1,000 IU (1 tablet)/day, orally. Tablets are repacked into blister package.
16145338|NCT01817686|Other|Comfort Default AD forms|Consenting subjects will be randomly assigned to one of 3 study arms. Subjects will receive a different AD form based on which arm they have been randomly assigned. Once a completed AD form is received, a debriefing session will be held to alert patients to exactly how the 3 ADs used in the study differ. Once patients are fully informed about the variations in the ADs, the patients will have an opportunity to change their AD selections prior to finalizing them as a part of their medical record. A final satisfaction interview will take place with a research associate who will contact patients via telephone to administer a satisfaction questionnaire.
16145339|NCT01817686|Other|Life Extension Default AD forms|Consenting subjects will be randomly assigned to one of 3 study arms. Subjects will receive a different AD form based on which arm they have been randomly assigned. Once a completed AD form is received, a debriefing session will be held to alert patients to exactly how the 3 ADs used in the study differ. Once patients are fully informed about the variations in the ADs, the patients will have an opportunity to change their AD selections prior to finalizing them as a part of their medical record. A final satisfaction interview will take place with a research associate who will contact patients via telephone to administer a satisfaction questionnaire.
16145340|NCT01817686|Other|Standard Default AD forms|Consenting subjects will be randomly assigned to one of 3 study arms. Subjects will receive a different AD form based on which arm they have been randomly assigned. Once a completed AD form is received, a debriefing session will be held to alert patients to exactly how the 3 ADs used in the study differ. Once patients are fully informed about the variations in the ADs, the patients will have an opportunity to change their AD selections prior to finalizing them as a part of their medical record. A final satisfaction interview will take place with a research associate who will contact patients via telephone to administer a satisfaction questionnaire.
16145341|NCT01817673|Dietary Supplement|creatine|20 g/d for 5 d followed by 5 g/d throughout the trial
16145342|NCT01817673|Dietary Supplement|placebo|
16145343|NCT01817660|Procedure|Open repair of popliteal artery|
16145344|NCT01817660|Procedure|Endovascular repair of popliteal artery|
16145345|NCT01817647|Procedure|Colorectal surgery|
16145346|NCT01817634|Dietary Supplement|Fish powder corn-soy blend'+ Fish oil capsule.|Omega 3 food supplement: 500 mg DHA + EPA, daily for 12 months. Omega 3 capsule: 500 mg DHA + EPA, daily for 12 months.
16145347|NCT01817634|Dietary Supplement|Fish powder corn-soy blend + corn oil capsule.|Omega 3 food supplement: 500 mg DHA + EPA, daily for 12 months. Control capsule: 0 mg DHA + EPA, daily for 12 months.
16145348|NCT01817634|Dietary Supplement|Corn-soy blend + fish oil capsule.|control food supplement: 0 mg DHA + EPA, daily for 12 months. Omega 3 capsule: 500 mg DHA + EPA, daily for 12 months.
16145349|NCT01817634|Dietary Supplement|Corn-soy blend + corn oil capsule.|control food supplement: 0 mg DHA + EPA, daily for 12 months. Control capsule: 0 mg DHA + EPA, daily for 12 months.
16145350|NCT01817621|Behavioral|Experimental Intervention|The experimental intervention arm will include the same measures as the TAU comparison study arm. In addition, participants will attend several sessions addressing body dissatisfaction, including psychoeducation on the antecedents and consequences of body dissatisfaction, the common comorbidity of depressed mood, and how these factors can affect HIV self-care behaviors.
16145351|NCT01817621|Behavioral|TAU|Participants assigned to the TAU condition will receive appropriate services and referrals as needed, as would be typical of patients at Fenway Health or MGH, and will attend bi-weekly appointments with a study research assistant (RA) to complete study questionnaires and assess pocketed adherence, including HAART doses that participants may have taken outside of Wisepill.
16145352|NCT01817595|Other|BG Star Meter (Conventional) Internet Blood Glucose Reporting|Patients in BG Star Meter Group will report using BG software through uploading information onto a computer and sending readings to their endocrinologist via email
16145353|NCT01817595|Other|iBG Star (iphone) Internet Blood Glucose Method|25 patients will be randomized to the iBGstar system will upload their readings to their iPhone and send in their readings using the iPhone.
16145354|NCT01817582|Drug|Lotemax|Lotemax gel will be administered as per the dose and schedule specified in the arms.
16145355|NCT01817582|Drug|Restasis|Restasis emulsion will be administered as per the dose and schedule specified in the arms.
16145356|NCT01817582|Drug|Soothe® Lubricant Eye Drops|
16145357|NCT01817556|Drug|Stillen Tab.|
16145358|NCT01817556|Drug|Mucosta Tab.|
16145359|NCT01817543|Device|AutoloGel|Autologel is a platelet-rich plasma gel used in the treatment of non-healing wounds
16145360|NCT01817530|Other|Elagolix placebo|oral coated tablet
16145361|NCT01817530|Drug|Elagolix|oral coated tablet
16145362|NCT01817530|Drug|0.5 mg estradiol / 0.1 mg norethindrone acetate|oral hard capsule
16145363|NCT01817530|Drug|1 mg estradiol / 0.5 mg norethindrone acetate|oral hard capsule
16145364|NCT01817530|Drug|E2/NETA placebo|oral hard capsule
16145365|NCT01817517|Device|Medtronic Activa Deep Brain Stimulation System|
16145366|NCT01817504|Procedure|Systematic transplantectomy|Transplantectomy within two months after return to dialyse. Antiproliferatives stop at the start of dialysis. Maintenance basic immunosuppressive treatment without dose reduction up to two weeks after transplantectomy. Abrupt discontinuation of the basic immunosuppressive treatment ttwo weeks after transplantectomy. Maintenance corticosteroids at 5mg per day until one month after transplantectomy then stop corticosteroids within one month.
16145367|NCT01817504|Procedure|Progressive reduction of immunosuppression|"Progressive reduction of immunosuppression. Transplantectomy for cause only. Antiproliferatives withdrawn at the start of dialysis. Maintenance of anticalcineurin or mTOR inhibitors half dose for 3 months, ¼ dose for 3 months and then stop. Maintenance corticosteroids for 6 months up to 5 mg per day, and then soft stop in 3 months.
~In case of transplantectomy by reason in the control group, basic immunosuppression will be continued at the maintenance dose during the current surgical procedure, and withdrawn two weeks later, similary to the strategy used in the study group."
16145368|NCT01817491|Other|American Heart Association Diet|
16145369|NCT01817491|Other|Reduced Fat Vegan Diet|
16145370|NCT01817478|Other|microbiologic sample|
16145371|NCT01817465|Drug|Motilitone ®|
16145372|NCT01817465|Drug|Pantoline®|
16145373|NCT01817465|Drug|Motilitone® and Pantoline®|
16145374|NCT01817452|Drug|Trastuzumab|
16145375|NCT01817452|Drug|Pertuzumab|
16145376|NCT01817452|Drug|Paclitaxel|
16145377|NCT01817439|Drug|Amiodarone|patients will be randomly assigned to oral OR IV Amiodarone
16145380|NCT01817413|Procedure|Mineral trioxide aggregate|An apical barrier of mineral trioxide aggregate (MTA cement) will be placed in the tooth root at the open apex in order to achieve root end closure via an apexification technique
16145381|NCT01817413|Procedure|Revascularisation|Pulp revascularisation will be induced by instrumentation through the open apex so that a blood clot forms within the root canal in order to achieve root end closure via apexogenesis
16145382|NCT01817400|Other|Microdialysis|"Microdialysis probes will be inserted into the abdominal and femoral subcutaneous adipose tissue. Two control probes at each site will be perfused at 2.0 µL/min with Ringer's solution to measure basal interstitial testosterone and estradiol levels. One experimental probe at each site will be perfused with the 'compound' 20ug/dl at 2.0 µL/min to assess the interstitial conversion of androstenedione to estrone and estradiol. The 'compound' will be infused. Either one or the other hormone (androstenedione OR testosterone) will be used per experiment. The second control probe will be positioned at each site to ensure acquisition of data in the event that one of the other probes becomes dysfunctional. We will then collect microdialysis samples every 60 min over the next 120 min."
16145383|NCT01817400|Dietary Supplement|Vascepa - Fish Oil|We will perform a control cycle of daily, first-morning voided urine, as previously reported by our group to assess the hormonal features of the menstrual cycle of each of the five participants in this arm. Upon completion of the control cycle, the participant will initiate therapy with aspirin 81mg per day, plus Vascepa 30mg daily. Participants will collect urine for a second menstrual cycle while on treatment, using methods that we have previously employed. At the completion of the second cycle of urine collection, the medications will be stopped and the study will be completed.
16145384|NCT01817400|Drug|Aspirin|
16145385|NCT01817400|Drug|Pioglitazone|e will perform a control cycle of daily, first morning voided urine as previously reported by our group, to assess the hormonal features of the menstrual cycle of each of the five participants. Upon completion of the control cycle, the participant will initiate therapy with pioglitazone, 45 mg daily, a dose that has previously been shown to result in a 30% reduction in fasting insulin. She will take the pioglitazone without any monitoring for a second menstrual cycle and then collect urinary hormones for the third menstrual cycle, continuing the pioglitazone until the third menstrual cycle is completed.
16145386|NCT01817387|Behavioral|PRIME|Mobile application designed to improve psychosocial functioning and motivational deficits
16145387|NCT01817387|Behavioral|Cognitive Training|Auditory processing, verbal learning, memory, processing speed, and social cognition
16145388|NCT01817374|Diagnostic Test|2D US grayscale plus quantitative VCEUS|This is a pilot study to evaluate quantitative VCEUS imaging for determining early breast cancer response to neoadjuvant chemotherapy, comparing results with volume change on grayscale US and planar CEUS, and correlating imaging findings with pathological response on surgical specimens.
16145389|NCT01817348|Procedure|Lidocaine group|"Patient position: prone position with arm under the abdomen and the elbow flexed to a right angle
~Injection with a 25-gauge, 1.5-inch long needle fitted with 3ml syringe filled with 3ml 1% lidocaine."
16145390|NCT01817348|Other|Physiotherapy (PT)|- Include electric therapy, hot pack, followed by stretch exercise and joint mobilization
16145391|NCT01817335|Procedure|psychosocial assessment and care|Participate in psycho-educational program
16145392|NCT01817335|Other|educational intervention|Participate in psycho-educational program
16145393|NCT01817335|Other|communication skills training|Participate in psycho-educational program
16145394|NCT01817335|Other|questionnaire administration|Ancillary studies
16145395|NCT01817322|Drug|Standard Dose of Myfortic and Reduced Dose of Myfortic|Low Dose of Neoral (Cyclosporine) and Standard Dose of Myfortic (Enteric-Coated Mycophenolate Sodium) vs. with Conventional Dose of Neoral (Cyclosporine) and Reduced Dose of Myfortic (Enteric-Coated Mycophenolate Sodium)
16145396|NCT01817322|Drug|Prednisolone OR methylprednisolone OR deflazacort injected both control group and experimental group|500 mg IV Injection in OP Day and 250 mg IV injection in POD1(1 Post op day). And then the drug dose is gradually reduced following the study institution's protocol. But the subject must be take the dose of 5mg of the drug per one day. The drug dose should be controlled on the basis of 5mg of Prednisolone. It can be used with the same dose of methylprednisolone 4 mg or deflazacort 6 mg.
16145397|NCT01817322|Drug|Basiliximab injected both control group and experimental group|The subject must be injected 20 mg of Simulect in Kidney transplantation day and just before the OP. After 4 days(96hour ± 12hr), the subject must be injected 20mg of Simulect, again.
16145398|NCT01817309|Other|endotoxin assay in peritoneal dialysis effluent|endotoxin level by Limulus Amebocyte Lysate (LAL) assay
16145399|NCT01817296|Procedure|Testicular Biopsy|Micro-dissection testicular sperm extraction for sperm retrieval
16145400|NCT01817283|Drug|Triptolide|Triptolide Wilfordii is a Chinese old herb which is widely used as a remedy for rheumatic diseases and nephropathy in China. It is approved that it can play a role as an immune modular.
16145401|NCT01817283|Drug|cART|Participants who will be enrolled in this trial would keep their previous combined antiretroviral therapy, such as zidovudine or stavudine plus lamivudine plus nevirapine or efavirenz.
16145402|NCT01817283|Drug|placebo|Placebo pills produced the same as Triptolide wilfordii.
16145403|NCT01817270|Biological|Live Attenuated Varicella Vaccine|
16145404|NCT01817257|Drug|Low Molecular Weight Heparin (LMWH)|Participants randomised to Arm A will have already received LMWH (Fragmin®), tinzaparin (Innohep®) or enoxaparin (Clexane®) at treatment dose for six months off trial, and should continue the same drug at the same dose for a further six months on trial. No dose alterations are required unless clinically indicated.
16145405|NCT01817244|Other|care management|6-month care management
16145406|NCT01817218|Drug|Platelet Rich Plasma|
16145407|NCT01817218|Device|Osakidetza protocol|"Patients in the control group will be treated following the recommendations of the Ezkerraldea-Enkarterri Health Region, that is, using a moist healing environment (as described in Uso racional de los productos de cura en ambiente húmedo. Plan de formación continuada de Osakidetza, 2011).
~The type of material used to treat and dress the wound will be chosen after the assessment of the wound and surrounding skin, type and quantity of exudate and whether there are signs of infection. Wound care will be carried out every 48-72 hours, as is the current usual practice."
16145408|NCT01817205|Procedure|TACE with Hyperthermia Treatment|"Transcatheter arterial chemoembolization (TACE) is performed under local anesthesia with right femoral puncture. The feeding lobar hepatic artery is selectively catheterized for drug delivery.
~Systemic hyperthermia is induced with an external energy source using microwave electromagnetic energy, with the patient lying supine on the treatment bed of the hyperthermia equipment, exposing the abdomen to the microwave transmitter."
16145412|NCT01817179|Other|FES neuroprosthesis to dorsiflexors on affected leg|
16145413|NCT01817166|Drug|Vitamin D|Patients will receive 100.000 UI of cholecalciferol every 14 days for a maximum of 24 months or until conversion to full multiple sclerosis has occurred.
16145414|NCT01817166|Drug|Placebo|Patients will receive a placebo treatment mimicking 100.000 UI of cholecalciferol every 14 days for a maximum of 24 months or until conversion to full multiple sclerosis has occurred.
16145415|NCT01817166|Other|Imaging|All patients are scheduled for MRI scans at baseline, 3 months, 12 months, 24 months, as well as upon conversion to full MS.
16145416|NCT01817166|Biological|Lumbar puncture|A baseline collection of cerebral spinal fluid may be required for certain patients (doctor's decision.)
16145417|NCT01817166|Biological|Blood sampling|Blood sampling is required of all patients at baseline, 3 months, 6 months, 12 months, 18 months and 24 months, as well as upon conversion to MS.
16145418|NCT01817166|Biological|Urine samples|Urine samples are required of all patients at baseline, 3 months, 6 months, 12 months, 18 months, 24 months, and upon conversion to MS.
16145419|NCT01817153|Drug|hydrocortison hemisuccinate|
16145420|NCT01817153|Drug|placebo followed by hydrocortisone hemisuccinate|
16145421|NCT01817114|Device|Auto Remote Ischemic Conditioning (AutoRIC) device|
16145422|NCT01817101|Dietary Supplement|Omega-3 fatty acid supplementation|Gelatine capsule, 1 at each meals (3 per day) during one year
16145423|NCT01817088|Procedure|New targeting procedure without electrophysiology|It is a neurosurgical procedure of electrodes implantation in the sub thalamic nuclei under general anaesthesia using a new targeting procedure without electrophysiology.
16145424|NCT01817088|Procedure|Classical neurosurgical procedure|It is a neurosurgical procedure of electrodes implantation in the sub thalamic nuclei under awake surgery with electrophysiological control. A second surgical step is performed to implant the subcutaneous stimulation device, under general anesthesia.
16145425|NCT01817075|Procedure|Chlorhexidine Gluconate Skin Cleanser|Given CHG cleansing
16145426|NCT01817075|Other|Laboratory Biomarker Analysis|Correlative studies
16145427|NCT01817075|Procedure|Mild Soap Skin Cleanser|Given control cleansing
16145428|NCT01817075|Other|Questionnaire Administration|Ancillary studies
16145429|NCT01817049|Behavioral|HAPA-based coach education workshop|A 3.5 hour workshop will target HAPA constructs by providing injury risk information (risk perceptions), FIFA 11+ effectiveness evidence (outcome expectancies), and hands-on experience administering the 11+ program to a soccer team (task self-efficacy). Action planning and coping planning exercises will also be conducted.
16145430|NCT01817049|Behavioral|placebo attention control|
16145431|NCT01817036|Dietary Supplement|Placebo|placebo
16145432|NCT01817036|Dietary Supplement|Vitamin D|400 IU vitamin D per pill
16145433|NCT01817023|Radiation|SIB-IMRT|SIB-IMRT was given to the patients with regimen of 69.96Gy-73.92Gy to the gross target volume, 60Gy to the high risk clinical target volume, 50Gy to the low risk clinical target volume
16145700|NCT01814904|Drug|colestilan-M|BSAeq 6 g/day
16145434|NCT01817023|Drug|Cisplatin|Cisplatin 100mg/m2 was delivered at d1,d22 and d43 to the CCRT group patients during radiotherapy.
16145435|NCT01817010|Behavioral|Multi-Component Rehabilitation (CMC)|
16145436|NCT01817010|Behavioral|Control (CON)|
16145437|NCT01816997|Drug|Pravastatin|"The impaired fasting glucose (IFG) subjects with total cholesterol 200-280 mg/dL were randomized into two groups: pravastatin 40 mg or rosuvastatin 10 mg.
~IFG subjects with total cholesterol less than 200 mg/dL will be served as controls."
16145438|NCT01816997|Drug|Rosuvastatin|"The impaired fasting glucose (IFG) subjects with total cholesterol 200-280 mg/dL were randomized into two groups: pravastatin 40 mg or rosuvastatin 10 mg.
~IFG subjects with total cholesterol less than 200 mg/dL will be served as controls."
16145439|NCT01816997|Drug|Control|placebo
16145440|NCT01816984|Drug|PI3K inhibitor BKM120|Given PO
16145441|NCT01816984|Biological|cetuximab|Given IV
16145442|NCT01816971|Drug|dexamethasone|Given IV or PO
16145443|NCT01816971|Drug|carfilzomib|Given IV
16145444|NCT01816971|Drug|lenalidomide|Given PO
16145445|NCT01816971|Procedure|autologous hematopoietic stem cell transplantation|Undergo autologous hematopoietic stem cell transplant
16145446|NCT01816971|Other|laboratory biomarker analysis|Correlative studies
16145447|NCT01816958|Other|co-administration of TMS and infused ketamine|co-administration of TMS and infused ketamine
16145448|NCT01816945|Behavioral|MOMBA web-based application|Web-based, interactive, social network application.
16145449|NCT01816932|Procedure|Home Visit|The intervention is the location of the insertion visit.
16145450|NCT01816919|Other|collecting breath samples|
16145451|NCT01816906|Device|Footwear :PU|"One group of patients will receive Footwear with PU insoles"
16145452|NCT01816906|Device|Footwear: MCP|One group of patients will receive footwear with MCP insoles
16145453|NCT01816893|Other|Hypoglycemic hyperinsulinemic clamp|
16145454|NCT01816893|Other|Euglycemic hyperinsulinemic clamp|
16145455|NCT01816867|Device|Intramesh T1 implantation|
16145456|NCT01816854|Device|Stenting|
16145457|NCT01816841|Procedure|fluorescence imaging|Undergo DVFE
16145458|NCT01816841|Procedure|biopsy|Undergo scalpel biopsy
16145459|NCT01816841|Procedure|examination|Undergo COE
16145460|NCT01816841|Procedure|Comparison of surgical margins by COE vs. DVFE|Surgical margin determination using DVFE
16145461|NCT01816828|Behavioral|Gay Poz Sex|Gay Poz Sex is a community-driven, peer-facilitated program for HIV+ gay and bisexual men. This eight week program is offered to small groups of 5-8 men and provides information about sexual health, the legal context of HIV non-disclosure and uses motivational interviewing to support each individual in setting and achieving a personal goal.
16145462|NCT01816828|Other|Wait List/Standard of Care|Participants are given referrals to existing resources in the community. Referrals and uptake will be tracked.
16145463|NCT01816815|Drug|BAY1002670|
16145464|NCT01816815|Drug|Placebo|
16145465|NCT01816802|Device|In-vitro fertilization using Eeva|Eeva will image embryos through cleavage stage (Day 3). Embryologists will use Eeva results along with traditional morphological grading to assist in selecting embryo(s) for transfer or freezing.
16145466|NCT01816789|Drug|rFSH|
16145467|NCT01816789|Drug|buserelin|
16145468|NCT01816776|Device|Treatment Group (transvenous stimulation of the phrenic nerve)|device implant, optimal medical therapy and device initiation 1 month post implant.
16145469|NCT01816776|Device|Control Group (Optimal Medical Therapy)|device implant, optimal medical therapy and delayed device initiation (7 months post device implant)
16145470|NCT01816763|Behavioral|NRS pain one week|Eligible patients will be randomly assigned to complete a patient-reported 'NRS one week' on a tablet prior to making contact with a nursing staff vital signs screener.
16145471|NCT01816763|Behavioral|PEG|Eligible patients will be assigned to complete a patient-reported enhanced pain screening with the PEG on a tablet prior to making contact with a nursing staff vital signs screener.
16145472|NCT01816763|Behavioral|DVPRS|Eligible patients will be randomly assigned to complete a patient-reported 'DVPRS' on a tablet prior to making contact with a nursing staff vital signs screener.
16145473|NCT01816750|Device|Cardiac GSI|A novel method of computed tomography scanning (Cardiac Gemstone Spectral Imaging - Cardiac GSI) and image reconstruction (Adaptive Statistical Iterative Reconstruction- ASIR.
16145474|NCT01816698|Drug|Taurine granule|1 package(1.6g taurine granule) once a day after meals, 12 weeks
16145475|NCT01816698|Drug|Placebo|Placebo: 1 package once a day after meals, 12 weeks
16145476|NCT01816685|Device|CPAP|
16145477|NCT01816672|Device|AutoloGel|Treatment with Autologel and standard of care twice a week for the first two weeks and once a week thereafter
16145478|NCT01816672|Other|Usual and Customary Care|Standard of care treatment twice weekly for 2 weeks then weekly
16145479|NCT01816659|Drug|Metformin ER|500 mg by mouth once daily, beginning the day after colonoscopy for one week, and then escalation to 1000 mg/day. The duration of the trial will be from the preoperative endoscopy till the surgery, and should be not less than 10 days and not more than 30 days.
16145480|NCT01816646|Drug|Cidofovir|2.5 mg/kg of cidofovir administered in 100 ml of normal saline solution through a transurethral catheter inside the bladder. The urinary catheter will be clamped for 2 hours.
16145481|NCT01816646|Drug|Probenecid|2 grams by mouth given approximately 3 hours prior to the bladder instillation of cidofovir.
16145482|NCT01816633|Device|AutoloGel|AutoloGel is a platelet-rich plasma (PRP) gel used in the treatment of non-healing chronic wounds. It will be administered twice weekly for 2 weeks then weekly
16145483|NCT01816620|Drug|Lenalidomide, Dexamethasone|"12 cycles of lenalidomide and dexamethasone, each cycle lasts 28 days. For patients with Ccr equal to or higher than 30ml/min, oral lenalidomide 10mg once daily for days 1-21 out of a 28 cycle.
~For patients with Ccr lower than 30ml/min, oral lenalidomide 10mg once every other day for days 1-21 out of a 28 cycle.
~All the patients take Dexamethasone orally 40mg once weekly for day 1,8,15,22 out of a 28 cycle."
16145484|NCT01816607|Procedure|new functional magnetic resonance imaging (MRI) protocols|diffusion-weighted MRI, dynamic-contrast enhanced MRI, MR spectroscopy, blood-level oxygen dependent (BOLD) MRI
16145485|NCT01816594|Drug|BKM120|Neo-adjuvant BKM120 (oral pan-class I PI3K inhibitor, continuous daily dosing). BKM120 was administered orally 100 mg/day.
16145486|NCT01816594|Drug|Trastuzumab|Trastuzumab is a humanized monoclonal antibody directed against the extracellular juxtamembrane domain of the HER2 receptor. Administered 4mg/kg i.v. load followed by 2mg/kg i.v. weekly.
16145487|NCT01816594|Drug|Paclitaxel|Paclitaxel is a cytotoxic agent with proven antitumor activity in a variety of solid tumors. The antitumor activity of paclitaxel is based on tubulin-binding and stabilization of non-functional microtubule bundles, thereby blocking normal mitotic spindle development and subsequent cell division. Administered weekly 80mg/m2 i.v.
16145488|NCT01816594|Drug|BKM120 Placebo|Neoadjuvant BKM120 placebo Administered orally 100 mg/day.
16145489|NCT01816581|Drug|Targin|
16145490|NCT01816581|Drug|Oxynorm|
16145491|NCT01816581|Drug|Morphine|
16145492|NCT01816568|Procedure|SILS appendectomy|Single incision laparoscopic appendectomy will be performed
16145493|NCT01816568|Procedure|Three port laparoscopic appendectomy|Three port laparoscopic appendectomy will be performed
16145494|NCT01816555|Dietary Supplement|Vitamin D|Subjects will be assigned to a dosage level between 600IU daily and 10,000IU daily depending on their age, weight and current vitamin D level
16145495|NCT01816542|Other|patch tests on healthy skin|Patches will be placed on healthy skin.
16145496|NCT01816529|Drug|Diltiazem Hydrochloride 2% Cream|0.2 g applied topically to the infrascapular area of the back.
16145497|NCT01816529|Drug|Vehicle Cream|Vehicle Cream, 0.2 g (contains no active pharmaceutical ingredient) applied topically to the infrascapular area of the back.
16145498|NCT01816529|Drug|0.1% solution of sodium lauryl sulfate (SLS)|0.2 mL applied topically to the infrascapular area of the back will serve as a positive control.
16145499|NCT01816529|Drug|Saline (0.9%)|0.2 mL applied topically to the infrascapular area of the back will serve as a negative control.
16145500|NCT01816516|Behavioral|Healthy Babies|"Each lesson is designed to promote the development of healthy infant eating, and incorporates research-based information, opportunities for mothers to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques. During lessons, mothers engage in activities in support of lesson goals. Intervention strategies focusing on feeding practices will include modification of the feeding environment (e.g., television off during feeding).
~The telephone contacts, 10 minutes in length, made at 6, 8, and 10 months, reinforce key concepts in the lessons after conclusion of the intervention to maintain effects."
16145501|NCT01816516|Behavioral|Expanded Food and Nutrition Education Program|Core EFNEP concepts are United States Department of Agriculture (USDA) My Pyramid, fruits, vegetables, meats, whole grains, food safety, and food resource management. Educators for the EFNEP group will use the EFNEP lessons which address basic knowledge customized for families with infants. Mothers in the EFNEP group will receive a series of six lessons from the nutrition education program offered in each state; they provide a series of lessons focused on nutrition education for families and do not include extensive content on feeding infants.
16145502|NCT01816503|Drug|No intervention|This is an observational study. The minimum initial dose will be fentanyl matrix 75 micrograms/h and the investigator can adjust the dosage according to the degree of the patients' pain control during the 9 days of the study period. Fentanyl matrix is a transdermal patch that is applied on the patient's skin.
16145503|NCT01816490|Drug|Intravenous Silibinin (iSIL)|
16145504|NCT01816477|Device|ON-Q soaker catheter system|"ON-Q soaker catheter system with Ropivicaine at 7 cc per hour placed by a single surgeon in the operating room. 7.5 catheters will be tunneled subcutaneously in the anterior axilla bilateral and secured with steri-strips and dressing. ON-Q systems will be primed with 750 cc and refilled accordingly to provide for 6 days of analgesia. Catheters will be removed by the surgeon in the hospital or clinic on the 6th post operative day. Patients may request removal of the catheter prior to the 6th day and this will not be considered a withdrawal from the study or complication and will be included in overall analysis, but noted accordingly."
16145505|NCT01816477|Drug|Epidural (ropivicaine 0.25%)|Thoracic epidural with Ropivicaine 0.25% placed pre-operatively by the anesthesiologist. Epidurals will remain in place for 72 hours and discontinued by the anesthesia pain management team.
16145506|NCT01816464|Biological|Trivalent Influenza Vaccine|"The formulation based on the WHO recommendation for influenza vaccines for 2013 for the Southern-hemisphere included the following vaccine strains:
~an A/California/7/2009 (H1N1)pdm09-like virus;
~an A/Victoria/361/2011 (H3N2)-like virus; - a B/Wisconsin/1/2010-like virus.
~The vaccine to be used in the study in 2013 is Vaxigrip (Sanofi Pasteur), or other equivalent licensed vaccine should the latter not be available, which will be procured commercially in pre-filled syringes. Using aseptic technique, participants will be injected with 0.5 mL of TIV from pre-filled syringe."
16145507|NCT01816451|Other|running training|The present study was designed to compare the physiological effects between the two training regimes and the control group.The subjects from interval and continuous group performed others activities as resistance training, swimming or soccer. Those activities wasn't controlled by our study, but the individual didn't do physical activities at least 3 hours before started our running sessions. The control group simply performed their normal physical activities (resistance training, swimming or soccer). But, each 3 weeks we had a contact with control group to check about any injury or illness that could affect the final results. None were found.
16145508|NCT01816425|Device|Thermoplastic partial denture|
16145509|NCT01816425|Device|CoCr partial denture|
16145510|NCT01816412|Device|MD02-LDCB Paclitaxel coated balloon catheter|
16145511|NCT01816412|Procedure|Standard Uncoated Balloon Angioplasty Catheter|
16145512|NCT01816399|Procedure|Routine coronary angiography|
16145513|NCT01816386|Other|Acupuncture Regimen|Patients in the acupuncture and the acupressure group will receive a standardised treatment comprising 12 SEIRIN® press needles (with a sharp tip) at 7 acupuncture points (Du 26, He 9, Ren 17, bilateral LI 4, He 9, LV 3, Ma 36 and Pe 6). The point regimen is based on consensus process of national and international experts. All needling will be documented by the acupuncturist. Application time is supposed to be 84-96 hours. Modification, especially less points according to the patients reaction during treatment is allowed.
16145562|NCT01816009|Other|duration of antibiotic treatment|Used antibiotics already have the AMM in this indication
16145563|NCT01815996|Other|One time blood draw to look at patient's DNA|One time blood draw to look at patient's DNA
16145564|NCT01815983|Other|Videolaryngoscopy review.|Review of video recordings.
16145565|NCT01815970|Behavioral|Pulmonary Rehabilitation|8 weeks of Pulmonary Rehabilitation including exercise and COPD related education.
16145514|NCT01816386|Other|Acupressure Regimen|Patients in the acupuncture and the acupressure group will receive a standardised treatment comprising 12 SEIRIN® press plasters (with a blunt knob instead a sharp needle) at 7 acupuncture points (Du 26, He 9, Ren 17, bilateral LI 4, He 9, LV 3, Ma 36 and Pe 6). The point regimen is based on consensus process of national and international experts. All needling will be documented by the acupuncturist. Application time is supposed to be 84-96 hours. Modification, especially less points according to the patients reaction during treatment is allowed.
16145515|NCT01816373|Device|Vacuum Bell|Patients with pectus excavatum will be submitted to a negative pressure treatment with the Vacuum Bell device
16145516|NCT01816360|Other|Olfactory aromatherapy|Inhalation of essential oils.
16145517|NCT01816360|Other|Yogatherapy|Yogatherapy respiratory exercises.
16145518|NCT01816347|Procedure|Routine PCI|
16145519|NCT01816334|Drug|methylprednisolone|
16145520|NCT01816334|Drug|Ketoprofen|
16145521|NCT01816334|Drug|Sodium Chloride|
16145522|NCT01816321|Drug|Corifollitropin alfa|Corifollitropin alfa 150μg on day 2 of the menstrual cycle (stimulation day 1)
16145523|NCT01816321|Drug|recombinant FSH|recombinant FSH 300IU/daily from day 2 of the cycle (stimulation day 8)until day of ovulation triggering
16145524|NCT01816321|Drug|Ganirelix|Ganirelix 0.25mg/daily from day 7 of the cycle(stimulation day 6) until day of ovulation triggering
16145525|NCT01816321|Drug|hp HMG|hp HMG 300IU/daily from day 9 of the cycle (stimulation day 8)until day of ovulation triggering
16145526|NCT01816295|Drug|Testosterone Solution|Administered topically to axillae.
16145527|NCT01816295|Drug|Placebo Solution|Administered topically to axillae.
16145528|NCT01816282|Drug|Evicel|Evicel (5ml) is sprayed over the soft tissue after the implant of prosthetic components and before wounding closure
16145529|NCT01816256|Procedure|Upper gastrointestinal endoscopy and Doppler ultrasound|This is a one arm study. All patients will receive two screening tests (Doppler ultrasound, upper gastrointestinal endoscopy).
16145530|NCT01816243|Drug|TTS-Fentanyl|Transdermal Therapeutic System (TTS)-fentanyl patches releasing fentanyl in the range of 12.5 to 100 microgram per hour (mcg/hr) rate. The initial dose of fentanyl TTS will be calculated based on each participant's opioid requirement. Patches will be usually replaced every 72 hours. Doses will be escalated in steps of 25 mcg/hr, if pain cannot be controlled. The study duration will be 30 days after first patch application.
16145531|NCT01816243|Drug|Morphine|Participants will be allowed the use of oral morphine syrup for the duration of TTS-fentanyl treatment to enable appropriate dose titration. It is expected that most of the participants will be titrated to an appropriate dose of TTS-fentanyl within 1 week.
16145532|NCT01816230|Drug|NiCord®|
16145533|NCT01816217|Device|Intubation with The McGrath Mac videolaryngoscope|
16145534|NCT01816204|Behavioral|Therapist assisted online treatment|7 weekly interactive online modules with 10-15 minute counselor consultation via video conference.
16145535|NCT01816204|Behavioral|face-to-face individual therapy|weekly individual counseling as usual.
16145536|NCT01816191|Drug|Diltiazem Hydrochloride Cream and Oral Diltiazem|
16145537|NCT01816178|Behavioral|communication training|Participants were instructed in the use of a voices output communication aid.
16145538|NCT01816165|Drug|Acipimox|Subjects will take acipimox 250mg by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day.
16145539|NCT01816165|Drug|Placebo|Subjects will take placebo by mouth four times a day for a total of seven days plus one dose the morning of the final study visit day
16145540|NCT01816152|Other|Tailored Active intervention|Subjects experience a baseline for 1 week and an active intervention for 4 weeks. The active intervention is a bluish white light source delivering at least 300 lux at the eye of the patient during at least 2 hours daily.
16145541|NCT01816152|Other|Inactive intervention|Subjects experience a baseline for 1 week and an inactive intervention for 4 weeks. The inactive intervention is a yellowish white light source delivering at most 50 lux at the eye of the patient during at least 2 hours daily.
16145542|NCT01816139|Drug|WC3011|
16145543|NCT01816139|Drug|Vehicle|
16145544|NCT01816113|Biological|ChAd63 PvDBP 5 x 10^9|1 dose of ChAd63 PvDBP 5 x 10^9 vp intramuscularly
16145545|NCT01816113|Biological|ChAd63 PvDBP 5 x 10^10|1 dose of ChAd63 PvDBP 5 x 10^10 vp intramuscularly
16145546|NCT01816113|Biological|MVA PvDBP 1 x 10^8|1 dose MVA PvDBP 1 x 108 pfu 8 weeks later intramuscularly
16145547|NCT01816113|Biological|MVA PvDBP 2 x 10^8|1 dose MVA PvDBP 2 x 108 pfu 8 weeks later intramuscularly
16145548|NCT01816100|Other|specifically design 6 month resistance training program|Data will be kept on the number of repetitions and amount of weight per exercise session See intervention description
16145549|NCT01816100|Behavioral|6 months weight resistance and balance program|3 phases first phase-strength improvement using stationary machines second phase-time is divided between stationary machines, balance, dexterity third phase-free weight movements
16145550|NCT01816087|Other|brief geriatric assessment|All participants will be screened for geriatric syndromes using the brief assessment tool. Mix a simple questions and simple tests
16145551|NCT01816074|Drug|Vyvanse (lisdexamphetamine)|Active ADHD drug, Vyvanse, is administered to mother.
16145552|NCT01816074|Behavioral|Behavior Parent Training|Mother is given 8 weeks of individual sessions of behavioral parent training
16145553|NCT01816061|Behavioral|Experimental - COMPASS|Controlled randomized clinical trial. Fifty-five participants in the intervention group will receive eight goal self-management sessions over a period of approximately ten weeks.
16145554|NCT01816061|Behavioral|Control - COMPASS|Increased hours of patient-provider interactions Group.
16145555|NCT01816048|Drug|TAK-700|TAK-700 will be administered at 300mg twice per day on 28-day continuous cycles
16145556|NCT01816048|Radiation|Fluorine F 18 Sodium Fluoride|Undergo NaF F18 PET/CT scan
16145557|NCT01816048|Procedure|Positron Emission Tomography|Undergo 18F NaF PET/CT scan
16145558|NCT01816048|Procedure|Computed Tomography|Undergo 18F NaF PET/CT scan
16145559|NCT01816035|Other|Laboratory Biomarker Analysis|Correlative studies
16145560|NCT01816035|Other|Pharmacological Study|Correlative studies
16145561|NCT01816035|Biological|Trastuzumab Emtansine|Given IV
16145701|NCT01814904|Drug|colestilan-H|BSAeq 9 g/day
16145566|NCT01815957|Drug|Rnalozine|. After enrollment in the study, participants will initiate Ranolazine for 4 weeks. The participant's usual anti-anginal medication regimen will be continued unchanged throughout study duration. Patients will receive Ranolazine 500 mg orally twice daily for 1 week, and the dose will be increased to 1,000 mg twice daily for an additional 3 weeks if tolerated.
16145567|NCT01815944|Drug|0.75% Ropivacaine|
16145568|NCT01815944|Drug|Normal saline|
16145569|NCT01815944|Drug|Dextrose 5%|
16145570|NCT01815918|Drug|Hydrocortisone|Patients randomized to treatment arm will three doses of 100 mg of hydrocortisone at the following times: prior to surgery, 8 hours after the first dose and 16 hours after the first dose.
16145571|NCT01815918|Drug|Placebo|Patients receive placebo prior to surgery, 8 hours after the first dose and 16 hours after the first dose.
16145572|NCT01815905|Other|Mobile program for occupational and speech therapy|
16145573|NCT01815905|Other|Traditional rehabilitation therapy|
16145574|NCT01815892|Drug|Withdrawal of furosemide|The patient (previously on furosemide) will have the furosemide stopped for 2 weeks. The interdialytic weight gain, BP and 24 hour urine volume and sodium excretion will be measured
16145575|NCT01815892|Drug|furosemide administration|The patient will receive 120 mgm furosemide daily for 2 weeks and the interdialytic weight gain, BP and 24 hr urine volume and sodium excretion will be measured.
16145576|NCT01815866|Procedure|CF with culturable NTM|CF patients who produce culturable aerosols of NTM will receive the following test: pulmonary function test, collecting a sputum culture if possible, coughing for 5 minutes into a tube connected to a canister, hypertonic saline and albuterol will be given after the 5 minutes of coughing and then they would repeat with another 5 minutes of coughing. There can be a break inbetween the coughing if needed.
16145577|NCT01815853|Radiation|Neoadjuvant Chemoradiotherapy|Radiotherapy (45Gy/25f) + 3 cycles of XELOX Chemotherapy (Capecitabine 1000mg/m2, d1-14 + Oxaliplatin 130mg/m2 d1; 21-days/cycle)
16145578|NCT01815853|Drug|Neoadjuvant Chemotherapy|3 cycles of XELOX Chemotherapy (Capecitabine 1000mg/m2, d1-14 + Oxaliplatin 130mg/m2 d1; 21-days/cycle)
16145579|NCT01815853|Procedure|R0 D2 Gastrectomy|
16145580|NCT01815853|Drug|Adjuvant Chemotherapy|3 cycles of XELOX Chemotherapy (Capecitabine 1000mg/m2, d1-14 + Oxaliplatin 130mg/m2 d1; 21-days/cycle)
16145581|NCT01815840|Drug|Vismodegib|Vismodegib 150 mg hard gelatin capsule orally once daily
16145582|NCT01815840|Drug|Placebo|Vismodegib placebo orally once daily
16145583|NCT01815827|Drug|inclacumab|single intravenous doses
16145584|NCT01815814|Other|Rolfing / Myofascial Structural Integration|"Rolfing is similar to deep massage. It is also known as myofascial structural integration."
16145585|NCT01815801|Other|Lungs were not mechanically ventilated during subclavian vein catheterization|Control group
16145586|NCT01815801|Other|Lungs were mechanically ventilated during subclavian vein catheterization|Ventilated group
16145587|NCT01815788|Device|Use of a personal sound amplifying device = TeoFirst|
16145588|NCT01815775|Other|clinical and imaging examinations|"Quantitative CSF flow study was performed by 2D phase-contrast velocity-encoded cine MRI (repetition/echo time, 15/7 ms; field of view = 140 x 140 mm²; matrix size = 256 x 128, flip angle = 25 degrees,one excitation, slice thickness = 5 mm). Cerebrospinal fluid flow was measured with a velocity-encoding value of 10-20 cm/s. Peripheral gating was used to cover the entire cardiac cycle with retrospective cardiac synchronization of 32 quantitative flow-encoded images per cycle.
~Clinical examination consists in neuropsychological assessment (including mini mental state examination test and Bradley's scale) as well as Hakim's triad evaluation"
16145589|NCT01815762|Other|Active arm|"In the active arm of the study, the number of ultrasound lung comets (ULC) will directly adjust the prescribed post-hemodialysis dry weight. See study flowchart on page 1.
~If the patient does not tolerate the intervention (as described above), he will continue the study in the medication arm, where the actual intervention in stopped, and extra cardio-protective drugs are added to the medication."
16145590|NCT01815749|Biological|autologous CD19CAR-CD28-CD3zeta-EGFRt-expressing Tcm-enriched T cells|Given IV
16145591|NCT01815749|Procedure|autologous hematopoietic stem cell transplantation|Undergo autologous hematopoietic stem cell transplantation
16145592|NCT01815749|Other|laboratory biomarker analysis|Correlative studies
16145593|NCT01815736|Drug|E/C/F/TAF|150/150/200/10 mg FDC tablet administered orally once daily
16145594|NCT01815736|Drug|E/C/F/TDF|150/150/200/300 mg FDC tablet administered orally once daily
16145595|NCT01815736|Drug|EFV/FTC/TDF|600/200/300 mg FDC tablet administered orally once daily
16145596|NCT01815736|Drug|RTV|100 mg tablet administered orally once daily
16145597|NCT01815736|Drug|ATV|300 mg capsule administered orally once daily
16145598|NCT01815736|Drug|FTC/TDF|200/300 mg tablet administered orally once daily
16145599|NCT01815736|Drug|COBI|150 mg tablet administered orally once daily
16145600|NCT01815723|Drug|FP187|500 mg FP187 daily, two tablets of 125 mg twice daily, from 125 mg daily up-titrated to full dose over a 4-week phase, total treatment phase of 20 weeks
16145601|NCT01815723|Drug|Dimethyl fumarate|720 mg Fumaderm® daily, two tablets of 120 mg three times daily, from 30 mg daily up-titrated to full dose over a 9-week phase, total treatment phase of 20 weeks
16145602|NCT01815723|Drug|FP187 placebo|FP187 matching placebo tablets in the same regimen as for FP187 arm
16145603|NCT01815723|Drug|Fumaderm® placebo|Fumaderm® matching placebo tablets in the same regimen as for Fumaderm® arm
16145604|NCT01815710|Other|Pediatric Asthma Clinical Pathway|Implementation of a clinical pathway outlining standardized, evidence-based care for pediatric patients with asthma. These clinical pathways use organized, time-sequenced interventions to achieve optimal patient outcomes.
16145605|NCT01815710|Other|Vomiting & Diarrhea Pathway|Implementation of a clinical pathway outlining standardized, evidence-based care for pediatric patients with vomiting and diarrhea. These clinical pathways use organized, time-sequenced interventions to achieve optimal patient outcomes.
16145702|NCT01814904|Drug|CBPB|
16145703|NCT01814891|Other|Orange maize feeding|This group was fed orange maize.
16145749|NCT01814553|Drug|afatinib|Daily treatment starting 40 mg per day
16145606|NCT01815697|Device|Enhanced External Counterpulsation|Enhanced external counterpulsation (EECP) is mainly used in cardiovascular and cerebrovascular diseases, which has been proven to be able to improve microcirculation and endothelial function. EECP therapy is done by sequential inflation of 3 sets of cuffs wrapped around the lower extremities during diastole and deflation of the cuffs during systole. The systolic deflation/ Diastolic inflation sequence of EECP leads to systolic unloading and diastolic augmentation, resulting in increased blood flow in a pulsatile manner. The patients will receive 35-36 hours EECP intervention, 1-hour session every day over a 7-week period.
16145607|NCT01815684|Drug|ASP3652|Oral
16145608|NCT01815684|Drug|Placebo|Oral
16145609|NCT01815671|Procedure|colonoscopy in the lateral horizontal position|colonoscopy in the lateral horizontal position with tilt down
16145610|NCT01815658|Device|Carbon fiber intramedullary nail (PEEK-CF)|Carbon fiber polyether-ether-ketone (PEEK-CF) PICCOLE Nail - produced by Carbofix, Herzlyia, Israel.
16145611|NCT01815645|Behavioral|ST+CM|12 weeks of the standard treatment offered by a open treatment service for drug addiction of the city of Sao Paulo (AME) plus Contingency Management
16145612|NCT01815645|Behavioral|standard treatment|12 weeks of standard treatment offered by AME (a open treatment service for drug addiction of the city of Sao Paulo)
16145613|NCT01815632|Other|Early infusion of autologous marrow|Intravenous infusion of autologous bone marrow without prior myeloablation on the day of bone marrow harvest and infusion of autologous blood at one year post-bone marrow harvest
16145614|NCT01815632|Other|Late infusion of autologous marrow|Infusion of blood on day of bone marrow harvest with intravenous infusion of autologous bone marrow without prior myeloablation one year post-bone marrow harvest.
16145615|NCT01815619|Other|on-site specimen evaluation|The specimen will be evaluated on-site by a cytopathologist during the procedure to render a diagnosis
16145616|NCT01815619|Other|off-site specimen evaluation|The specimen will be evaluated off-site by a cytopathologist
16145617|NCT01815606|Procedure|biopsy with 19 gauge needle|biopsy with 19 gauge needle
16145618|NCT01815606|Procedure|biopsy with 25 gauge needle|biopsy with 25 gauge needle
16145619|NCT01815593|Device|Enhanced external counterpulsation|Enhanced external counterpulsation therapy is done by sequential inflation of 3 sets of cuffs wrapped around the lower extremities during diastole and deflation of the cuffs during systole. The systolic deflation/ Diastolic inflation sequence of EECP leads to systolic unloading and diastolic augmentation, resulting in increased blood flow in a pulsatile manner. The patients receive 35-36 hours EECP intervention, 1 -hour session every day over a 7-week period.
16145620|NCT01815580|Drug|Atripla or Stribild|Antiretroviral therapy
16145621|NCT01815541|Drug|teicoplanin|
16145622|NCT01815528|Drug|Catumaxomab|"Catumaxomab dosing comprises the following four intraperitoneal (i.p.) infusions via an i.p.-port or an indwelling catheter:
~10 µg on day 0
~20 µg on day 3
~50 µg on day 7
~150 µg on day 10"
16145623|NCT01815515|Drug|18F-DCFBC|"18F-DCFBC is a radiofluorinated small-molecule inhibitor of prostate-specific membrane antigen (PSMA).
~A bolus of 10 mCi (370 MBq) [9-11 mCi (333-407 MBq)] of 18F-DCFBC will be injected into the IV line by slow IV push."
16145624|NCT01815502|Diagnostic Test|Cardiac catheterization|All patients will receive a dobutamine infusion during catheterization. Patients were 1:1 randomized to a single dose of 1 mg/kg of sildenafil (max dose of 20 mg) or placebo 30-90 min prior to beginning of catheterization.
16145625|NCT01815476|Radiation|Radiation Therapy Positioning Intervention|All participants will receive an adjuvant XRT dose to the breast of 50Gy in 25 fractions using an IMRT technique. In both arms, boost to the surgical bed using a mini-tangent technique will be delivered at the treating oncologist's discretion. Acceptable boost doses are 1600cGy/8 fractions, 1000cGy/5 fractions or 1325cGy/25 fractions as a simulatenous integrated boost. Participants randomized to the supine arm will be positioned supine on an angled breast board, with the ipsilateral arm abducted over her head. Participants randomized to the prone arm will be positioned prone on a prone breast board with both arms immobilized above the participant's head. The us of a cushion-like VaclocTM device is permitted at the treating physician's discretion. Radiation beams will be shaped to encompass the breast volume requiring treatment in both arms.
16145626|NCT01815450|Drug|BLI1100|BLI1100 topical cream
16145627|NCT01815450|Drug|BLI1100 - modified formulation|BLI1100 topical cream
16145628|NCT01815450|Drug|Placebo|Placebo topical cream
16145629|NCT01815437|Dietary Supplement|Mushroom Vitamin D2|2000 IU vitamin D2 in a mushroom extract, once/day for 12 weeks
16145630|NCT01815437|Dietary Supplement|Cholecalciferol|2000 IU crystalline cholecalciferol once/day for 12 weeks
16145631|NCT01815437|Dietary Supplement|Vitamin D2 - Ergocalciferol|2000 IU vitamin D2, ergocalciferol once/day for 12 weeks
16145632|NCT01815437|Dietary Supplement|Mushroom Extract|Same quantity of mushroom extract in a capsule
16145633|NCT01815424|Drug|placebo|placebo BID for 16 weeks and then re-randomized into active groups
16145634|NCT01815424|Drug|CP-690,550|CP-690,550 5mg BID for 52 weeks
16145635|NCT01815424|Drug|CP-690,550|CP-690,550 10mg BID for 52 weeks
16145636|NCT01815411|Dietary Supplement|Mushroom extract|The mushroom extract (Andosan) is given orally in doses 30 m x 2 daily for 21 days
16145637|NCT01815398|Behavioral|Cognitive Remediation|Neuropsychological Educational Approach to Remediation (NEAR) is an evidence based, manualized cognitive remediation program that targets cognitive deficits (eg memory, processing speed, executive functioning, working memory and attention) with the intent of improving daily functioning.NEAR is conducted in a small group setting, allowing for supportive social interaction while participants work at their own computer station on engaging computerized activities that are selected to address their unique profile of cognitive deficits. Then, as a group they discuss how their respective cognitive activities will help them achieve their vocational goals.
16145638|NCT01815398|Behavioral|Computer Skills Training|Participants utilize an interactive software program that delivers tutorials, lessons, and practice sessions to develop computer skills for office based employment. During the learning activities, the clinician offers coaching and assistance in setting up computerized training exercises as needed.
16145639|NCT01815372|Procedure|Single penetration dual injection (SPEDI) block technique to block the sciatic and the saphenous nerve with one needle penetration of the skin|
16145640|NCT01815372|Procedure|The classical popliteal sciatic nerve block combined with the mid-femoral saphenous nerve block|
16145644|NCT01815346|Procedure|Acupuncture|"One group receives acupuncture 2 times a week for 6 weeks.
~One group receives acupuncture 3 times a week for 4 weeks.
~Participants receive acupuncture to the arms, legs, and abdomen. The acupuncture needles will be left in place for about 20 minutes."
16145645|NCT01815346|Behavioral|Questionnaires|Three questionnaires completed at baseline, midpoint, and four weeks after completion of acupuncture treatment.
16145646|NCT01815346|Other|Hand Function and Balance Tests|Tests completed at baseline, midpoint, and four weeks after completion of acupuncture treatment. These tests should take about 20 minutes to complete.
16145647|NCT01815333|Drug|Feraheme|6 mg of iron/kg (maximum 510 mg/dose) injected at a rate of 1 ml/sec (30 mg/sec) or slower after initial MRI.
16145648|NCT01815333|Procedure|Magnetic Resonance Imaging (MRI)|MRI scan performed before Feraheme injection. After Feraheme injection, MRI scan performed 2 days later, and then again the following day.
16145649|NCT01815320|Procedure|Contrast-enhanced ultrasound (CE-US)|
16145650|NCT01815320|Device|SonoVue|
16145651|NCT01815307|Drug|Gemcitabine|1000mg/m2, day 1 every 2 weeks
16145652|NCT01815307|Drug|S-1|80mg/m2/day, day 1-28, every 6 weeks
16145653|NCT01815294|Drug|DOXIL/CAELYX (doxorubicin) Treatment Sequence AB|Cycle 1 = Treatment A, Cycle 2 = Treatment B
16145654|NCT01815294|Drug|DOXIL/CAELYX (doxorubicin) Treatment Sequence BA|Cycle 1 = Treatment B, Cycle 2 = Treatment A
16145655|NCT01815281|Device|Foot Mechanical Stimulation (GONDOLA)|
16145656|NCT01815268|Biological|HD Vaccine|Nursing home residents over 65 years are allocated to receive high-dose vaccine. Residents under 65 years are provided standard-dose vaccine.
16145657|NCT01815268|Biological|SD Vaccine|Nursing home residents are allocated to receive standard-dose vaccine.
16145658|NCT01815268|Biological|Free Vaccine|Nursing home facilities are provided free standard-dose vaccine for their staff.
16145659|NCT01815268|Biological|Usual Care|Nursing home staff will have access to influenza vaccine, per standard of care. No free vaccine provided as part of study.
16145660|NCT01815255|Drug|tenofovir (TDF)|
16145661|NCT01815242|Drug|nab-Paclitaxel|
16145662|NCT01815242|Drug|Gemcitabine|
16145663|NCT01815242|Drug|Carboplatin|
16145664|NCT01815229|Procedure|tracheal lavages|tracheal lavages obtained during endotracheal intubation.
16145665|NCT01815216|Procedure|Bariatric surgery|Gastric bypass surgery
16145666|NCT01815216|Behavioral|Brain activity in resting state|Measure of activity in brain networks during resting state
16145667|NCT01815216|Behavioral|Memory performance|"Assess concentration in 2D-location task (i.e. memory game)"
16145668|NCT01815203|Drug|Caffeine|Administration of one gelatin capsule containing 200-300 mg of caffeine with subsequent cognitive tasks and food test.
16145669|NCT01815203|Drug|Placebo|Administration of placebo with subsequent cognitive tasks and food test.
16145670|NCT01815177|Device|Arthroscopic transosseous fixation|
16145671|NCT01815177|Device|Suture anchors|
16145672|NCT01815164|Behavioral|Hypnotherapy|Gut-directed hypnotherapy administered by an experienced hypnotherapist.
16145673|NCT01815164|Behavioral|Educational intervention|Educational intervention vith education regarding Irritabel bowel Syndrome.
16145674|NCT01815138|Drug|hCG|Adjuvant low dose hCG 1,000 IU administered at the time of GnRH agonist trigger
16145675|NCT01815138|Drug|hCG|Adjuvant low dose hCG 1,500 IU administered 35 hours after GnRH agonist trigger
16145676|NCT01815125|Drug|Ondansetron|The intervention of interest will be the administration of one dose of oral ondansetron in the emergency department. The dosage will be 8 mg.
16145677|NCT01815125|Drug|PLacebo|placebo
16145678|NCT01815112|Other|Magnetic resonance imaging|CSF flow measurement at Sylvius' aqueduct and cervical levels. Apparent diffusion coefficient and fractional anisotropy determination in corpus callosum, cingulum and hippocampus.
16145679|NCT01815112|Other|Positron emission tomography|Tissue-time activity curves in hippocampus, cingulum, medio-temporal cortex and choroid plexus.
16145680|NCT01815099|Device|rTMS Treatment|Either 10 or 15 rTMS sessions (2 or 3 times/week for 5 weeks, respectively)
16145681|NCT01815086|Biological|Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg)|Single infusion of 124I-labeled anti-amyloid mAb 11-1F4: 2 mCi (1 mg)
16145682|NCT01815073|Biological|Live Attenuated Varicella Vaccine + Live Attenuated JE Vaccine|
16145683|NCT01815073|Biological|Live Attenuated Varicella Vaccine|
16145684|NCT01815073|Biological|live attenuated JE vaccine|
16145685|NCT01815047|Dietary Supplement|Vitamin D3 Supplementation|
16145686|NCT01815021|Dietary Supplement|amorphous calcium carbonate|
16145687|NCT01815021|Dietary Supplement|crystalline calcium supplements|
16145688|NCT01815008|Drug|Clopidogrel|Clopidogrel 75 mg daily
16145689|NCT01815008|Drug|Aspirin|Aspirin 81 mg daily
16145690|NCT01814995|Behavioral|Nutrition/Physical Activity Intervention|Please see Arm description.
16145691|NCT01814982|Drug|JNJ-17299425|JNJ-17299425 will be administered at a starting dose of 1 milligram (10 milliliter of a 0.1 mg/ml solution) as intravenous bolus injection over 2 minutes in central vein.
16145692|NCT01814969|Radiation|Hyperfractionated Radiochemotherapy|28 x 1.5Gy 2 times a day; gap between the fractions min. 6-8h - duration of treatment 2.5 weeks + simultaneous bolus 5-Fluorouracil (the each cycle consisted of 5-fluorouracil 325 mg/m2 per day) on 1-3 and 16-18 (last 3 days of radiotherapy).
16145693|NCT01814969|Radiation|Hyperfractionated Radiotherapy|28 x 1.5Gy 2 times a day; gap between the factions min. 6-8h - duration of treatment 2.5 weeks
16145694|NCT01814956|Drug|Lipoplus 20%|Lipoplus 20% (MCT/LCT/FO) i.v. lipid emulsion for parenteral nutrition
16145695|NCT01814956|Drug|Lipofundin N 20%|Lipofundin N 20% (LCT, soy bean oil) i.v. lipid emulsion for parenteral nutrition
16145696|NCT01814930|Behavioral|Brief standardized contraceptive counseling intervention|The intervention employed an in-person counseling strategy that included empowerment messaging and an instrument to clarify the participants' preferences for contraception in the context of their goals for future childbearing.
16145697|NCT01814917|Drug|colestilan|body surface area equivalent (BSAeq) 3 g/day, 6 g/day, 9 g/day, 12 g/day or 15 g/day
16145698|NCT01814917|Drug|CBPB|
16145699|NCT01814904|Drug|colestilan-L|body surface area equivalent (BSAeq) 3 g/day
16145704|NCT01814891|Other|Vitamin A supplement|This group received a dose of vitamin A at the estimated average requirement each feeding day of the intervention.
16145705|NCT01814891|Other|Oil only|This group received a small amount of plain oil without vitamin A.
16145706|NCT01814878|Drug|Tramadol HCl/Acetaminophen ER|2 tablets of ER (tramadol HCl [75 mg]/acetaminophen [650 mg]) will be administered at 0, 12, 24 and 36 hours
16145707|NCT01814878|Drug|Tramadol HCl/Acetaminophen IR|2 tablets of IR (tramadol HCl [37.5 mg]/acetaminophen [325 mg]) at 0, 6, 12, 18, 24, 30, 36 and 42 hours
16145708|NCT01814865|Drug|Abiraterone Acetate|1000 mg PO OD x 2 weeks
16145709|NCT01814865|Drug|Prednisone|5 mg PO OD x 2 weeks
16145710|NCT01814865|Drug|Aromatase Inhibitor|1 mg PO OD x 2 weeks
16145711|NCT01814852|Device|Shockwave system|
16145712|NCT01814852|Device|Sham treatment|Sham treatment that looks, sounds and feels like real LI-ESWT treatment by Renova.
16145713|NCT01814839|Drug|ALN-TTRSC (revusiran)|Ascending doses of ALN-TTRSC (revusiran) by subcutaneous (SC) injection
16145714|NCT01814839|Drug|Sterile Normal Saline (0.9% NaCl)|Calculated volume to match active comparator
16145715|NCT01814826|Drug|MLN4924|"MLN4924 intravenously (IV) in AML participants in a 28-day cycle:
~MLN4924 on Days 1, 3, and 5 for Cycle 1 and all subsequent cycles"
16145716|NCT01814826|Drug|Azacitidine|"Azacitidine (IV) or subcutaneously in AML participants in a 28-day cycle:
~- Azacitidine Days 1, 2, 3, 4, 5, 8, 9 in Cycle 1 and for all subsequent cycles"
16145717|NCT01814813|Biological|HSPPC-96|intradermal infusion
16145718|NCT01814813|Drug|bevacizumab|intravenous
16145719|NCT01814800|Biological|RI-002|Immune Globulin Intravenous (IGIV)
16145720|NCT01814787|Other|CHICA Type 2 Diabetes Module|Information with regard to family history of type 2 diabetes, race/ethnicity, and maternal history of gestational diabetes will be gathered for every patient. This data will then be utilized by the CHICA system when a child is age 10 or older and presents to the clinic. Data regarding the child's BMI at that time will be analyzed by the CHICA system. If the child's BMI > 85th percentile, a prompt will appear on the provider worksheet asking the clinician whether the child might have insulin resistance. All information will then be analyzed to determine whether the child has 2 or more risk factors for the development of type 2 diabetes. If at least 2 risk factors are present, then the CHICA system goes on to coordinate the diagnosis and long-term management of type 2 diabetes.
16145721|NCT01814774|Other|No Intervention|No treatment (intervention) was administered.
16145722|NCT01814761|Drug|Bimatoprost 0.01%|One drop of bimatoprost 0.01% (Lumigan® 0.01%) in the affected eye(s) every evening for 12 weeks.
16145723|NCT01814748|Drug|Omarigliptin|Omarigliptin 25 mg capsule administered orally once weekly
16145724|NCT01814748|Drug|Placebo to omarigliptin|Matching placebo to omarigliptin 25 mg capsule administered orally once weekly
16145725|NCT01814748|Drug|Metformin|Open-label metformin (dosed daily according to the country-specific product label) was to be initiated for participants meeting protocol-specified glycemic criteria, but was otherwise prohibited.
16145726|NCT01814735|Other|Brown rice|
16145727|NCT01814735|Other|White rice|
16145728|NCT01814709|Drug|GDC-0032|Oral doses of GDC-0032
16145729|NCT01814709|Drug|Itraconazole|Oral doses of Itraconazole
16145730|NCT01814709|Drug|Rifampin|Oral doses of Rifampin
16145731|NCT01814696|Device|MedSentry System|Subjects will use the MedSentry System and electronic pillbox, to manage their medications.
16145732|NCT01814683|Drug|Primaquine|14 days of supervised primaquine (7mg/kg total dose) administered once per day (0.5 mg/kg).
16145733|NCT01814683|Drug|Primaquine|7 days of supervised primaquine (7mg/kg total dose) administered once per day (1.0 mg/kg OD) followed by 7 days of placebo.
16145734|NCT01814683|Drug|Placebo|14 days placebo.
16145735|NCT01814670|Biological|botulinum toxin Type A|20 units botulinum toxin Type A (total dose) injected into frown lines on Day 1.
16145736|NCT01814657|Drug|Lidocaine hydrochloride (HCl) 1% solution|Comparison of paracervical block using Lidocaine versus Normal Saline placebo in patients undergoing oocyte retrieval during IVF.
16145737|NCT01814657|Drug|Sterile Normal Saline%|Sterile normal saline used as placebo for lidocaine hydrochloride (HCl)1% solution
16145738|NCT01814644|Behavioral|TRIMM Intervention|Individuals in the TRIMM arm receive daily, individualized text-messages promoting positive lifestyle changes to support weight loss/management.
16145739|NCT01814644|Behavioral|Standard Care|Individual assessment, lifestyle counseling
16145740|NCT01814631|Other|image quality and resolution|Image quality and resolution will be viewed using Aloka processor
16145741|NCT01814631|Other|image quality and resolution|image quality and resolution will be viewed on the EU-me2
16145742|NCT01814618|Drug|Budesonide Respules|Subjects irrigate their noses with budesonide respules. They will use one respule per nostril twice daily for three months.
16145743|NCT01814605|Procedure|Infragluteal space group|"Sciatic Nerve Block Infragluteal group: Ultrasound scanning will be used to identify and mark the greater trochanter laterally and the ischial tuberosity medially. The midpoint between these two structures is a rough non-binding estimate of the approximate location of the sciatic nerve. The sciatic nerve is usually found anterior (deep) to the gluteus maximus muscle and lateral to the origin of the biceps femoris muscle at the ischial tuberosity as well as medial to the greater trochanter.
~The end point of nerve block in this group is obtaining a circumferential local anesthetic spread around the sciatic nerve."
16145744|NCT01814605|Procedure|Subgluteal space group|Subgluteal space group: The operator will identify the gluteus maximus and biceps femoris muscles at the level of the greater trochanter and ischial tuberosity and the infragluteal space.
16145745|NCT01814592|Procedure|coronally partial thickness flap plus connective tissue|The design of the flap will be performed according to the technique described by de Sanctis and Zucchelli 2007.
16145746|NCT01814592|Procedure|coronally mucosal thickness flap|The design of the flap will be performed according to the technique described by Greenwell H, Vance G, Munninger B and Johnston H.
16145747|NCT01814579|Device|Unidirectional Barbed Suture (V-Loc)|Patients enrolled in the Unidirectional Barbed Suture arm will have their vaginal cuff closed using this device during their robotic hysterectomy.
16145748|NCT01814579|Device|polyglactin 910 (Vicryl)|Patients in the Smooth Suture arm will have their vaginal cuff closed with this device during their robotic hysterectomy.
16145750|NCT01814553|Drug|loperamide|Follow cohort assignment and diarrhea management guidelines
16145751|NCT01814540|Dietary Supplement|Bovine Milk Oligosaccharide|The BMO powder will be isolated from whey streams by Hilmar Ingredients (Hilmar, California 95324). Hilmar Ingredients employs the same membrane filtration, and centrifugation processes used to purify whey protein in their commercial practice to extract and purify BMO from whey permeate. Furthermore, the same sterilization processes used on the equipment to purify whey products will be used to purify BMO. This method uses a novel high-throughput food-grade isolation protocol that leads to purification of specific BMOs with bifidogenic activity as prebiotic oligosaccharides that mimic the activities observed for Human Milk Oligosaccharides (HMO). This strategy of developing methods for their large scale fractionation allows us to obtain a final product that mimics the naturally beneficial oligosaccharides present in human milk.
16145752|NCT01814540|Dietary Supplement|Placebo Glucose Polymer|
16145753|NCT01814527|Dietary Supplement|Docosahexaenoic acid|5 capsules containing 440mg of Docosahexaenoic acid (DHA)for total daily dosing of 2200mg of DHA daily
16145754|NCT01814527|Drug|Placebo|5 capsules that are identical to the treatment.
16145755|NCT01814514|Drug|Timolol-trusopt|
16145756|NCT01814514|Drug|placebo|
16145757|NCT01814501|Biological|panitumumab|Given IV
16145758|NCT01814501|Drug|irinotecan hydrochloride|Given IV
16145759|NCT01814501|Drug|fluorouracil|Given IV
16145760|NCT01814501|Drug|leucovorin calcium|Given IV
16145761|NCT01814488|Procedure|allogeneic transplant|"Allogenic transplant using either a Marrow Unrelated Donor or a Cord Blood unit or a family Haploidentical donor.
~The conditioning regimen in standard use is:
~Thiotepa (Tepadina) i.v. 5 mg/kg/daily (total dose 10 mg/kg) day -7 and -6;
~Busulfan (Busilvex) i.v. 3,2 mg/kg/day (total dose 9,6 mg/kg) as a single daily dose day -5, -4, -3;
~Fludarabine i.v. 50 mg/m2 (total dose150 mg/m2) day -5, -4, -3.
~Primary antifungal prophylaxis is Micafungin 50 mg/die i.v. (1 mg/kg if <40 kg) day 0 to engraftment. After engraftment continue antifungal prophylaxis according to local practice."
16145762|NCT01814475|Drug|A: Fludarabine + Busulphan|Fludarabine 30 mg/m2/d, day -8 to day-3 and Busulphan (Busilvex) 0,8 mg/Kg/i.v. dose x 4 doses on days -5,-4 and x 2 doses on day -3, total dose 8 mg/Kg) prior allogenic transplant (day zero)
16145763|NCT01814475|Drug|B: Fludarabine + Thiotepa|Fludarabine 30 mg/m2/d day -8 to day -3 Thiotepa 6 mg/Kg for 2 doses ( days -4, -3) prior allogeneic transplant (day zero)
16145764|NCT01814462|Device|6 months CPAP|
16145765|NCT01814449|Other|18FMISO PET/CT scan|The baseline 18F-FMISO PET/CT scans were scheduled before initiation of endocrine therapy. All patients were injected intravenously with 370 MBq of 18F-FMISO and PET/CT static emission scans were conducted at 4 hours after injection.
16145766|NCT01814449|Drug|Letrozole|Patients were assigned to primary endocrine therapy with letrozole 2.5mg daily for at least 4 months.
16145767|NCT01814436|Device|scaffold-free SHED-derived pellet|The purpose of this clinical trial is to both clarify the efficiency of autologous SHED to regenerate pulp and periodontal tissue in the patients with avulsed immature permanent teeth and pulp necrosis to confirm the safety of using autologous stem cells in clinical endodontic regenerative medicine.
16145768|NCT01814423|Drug|Chloroquine-base 50 mg|
16145769|NCT01814423|Drug|Chloroquine-base 70 mg|
16145770|NCT01814410|Drug|Intravenous ethanol placebo plus nicotine infusions|nicotine infusions: 1) placebo; 2) nicotine 0.5 mg/70 kg; 3) nicotine 1.0 mg/70 kg
16145771|NCT01814410|Drug|intravenous ethanol 40mg% plus nicotine infusions|nicotine infusions: 1) placebo; 2) nicotine 0.5 mg/70 kg; 3) nicotine 1.0 mg/70 kg
16145772|NCT01814410|Drug|intravenous ethanol 100mg% plus nicotine infusions|nicotine infusions: 1) placebo; 2) nicotine 0.5 mg/70 kg; 3) nicotine 1.0 mg/70 kg
16145773|NCT01814397|Drug|Anastrozole|1 mg orally daily
16145774|NCT01814397|Drug|exemestane|25 mg orally daily
16145775|NCT01814397|Drug|letrozole|2.5 mg orally daily
16145776|NCT01814384|Device|prosthesis GMK ® without the ancillary MyKnee ® LBS|
16145777|NCT01814384|Device|Matched patient cutting blocks MyKnee ® LBS|
16145778|NCT01814371|Drug|2% mupirocin ointment|Participants over 1 month of age, apply ointment to the anterior nares twice daily for 5 days.
16145779|NCT01814371|Other|Bleach Bath (dilute)|Participants over 1 month of age, pour 1/4 cup of bleach into a bath tub filled 1/4 full of water. Soak in bath for 15 minutes daily for 5 days.
16145780|NCT01814371|Behavioral|Hygiene Protocol|"Follow key hygiene tips:
~Throw out all lotions or creams that you dip your hands into and replace with pumps or pour bottles.
~Use liquid(pour or pump) soaps instead of bar soaps.
~Wash hands frequently or use hand sanitizer(with more than %60 alcohol) such as Germ-X or Purell.
~Do not share personal care items such as razors, brushes, or deodorant.
~Wash all sheets and towels in hot water. Wash sheets every week.
~Use towels and wash cloths only once before washing and do not share."
16145781|NCT01814358|Dietary Supplement|Whey protein powder|Subjects on this arm will consume 20g whey protein powder mixed with water 15 minutes prior to breakfast, lunch, and dinner for two days
16145782|NCT01814358|Dietary Supplement|Control protein|Subjects on this arm will consume 20g gelatin protein powder mixed with water 15 minutes prior to breakfast, lunch, and dinner for two days
16145783|NCT01814332|Drug|GSK561679|GSK561679, oral administration, 350mg/day, 6 week administration
16145784|NCT01814332|Drug|Placebo|Placebo compound treatment for comparison with IP
16145785|NCT01814319|Drug|Probenecid 1 gr oral twice daily|Probenecid 1 gram oral twice daily
16145786|NCT01814319|Drug|Placebo|Matching placebo oral twice daily
16145787|NCT01814306|Device|Supreme LMA|Use Supreme LMA to compare efficay with Proseal LMA in prone position insertion
16145788|NCT01814306|Device|Proseal LMA|Use Proseal LMA to compare efficay with Supreme LMA in prone position insertion
16145789|NCT01814293|Device|Handheld humidifier|Subjects will be randomized into 2 groups: handheld humidifier group (FDA cleared medical device that uses distilled water) & control group. Both groups may use any supportive modalities desired such as over-the-counter cold medications (OTCs), room air humidifier etc. Follow up surveys will be obtained on days 1 and 2 following the ED visit to assess whether then intervention (use of handheld humidifier) improved symptom scores or reduced the use of OTC medications or room humidifier.
16145790|NCT01814280|Other|Medication review|Medication review performed by either a clinical pharmacist or a clinical pharmacologist
16145859|NCT01813734|Drug|Ponatinib|28 day cycle
16145791|NCT01814267|Other|telemedicine|"Intervention group: care and follow-up through telemedicine (e-consultations)
~1 hospital consultation at inclusion time, week 0
~then every 15 days, after the transmission of medical data and photos via internet by the nurse, telemedicine e-consultations until the wound has healed (week 2,week 4, week 6, week 8, week 10, week 12, week 14, week 16, week 18, week 20, week 22, week 24 : end point study), i.e. 12 e-consultations over a 6-month period.
~1 hospital consultation to validate that the wound is well-healed"
16145792|NCT01814267|Other|conventional|"conventional group: iterative diabetes physicians consultations at hospital
~1 consultation at inclusion time, week 0
~1 consultation 2 weeks after inclusion, week 2
~1 consultation per month until the wound has healed (week 4, week 8, week 12, week 16, week 20, week 24: end-point study), i.e. 6 consultations over a 6-month period
~1 consultation to validate that the wound is well-healed"
16145793|NCT01814241|Drug|Open label peanut OIT|Subject will take increasing amounts of peanut protein up to a maximum maintenace dose of 1450mg.
16145794|NCT01814228|Procedure|transcatheter ablation of ganglionated plexi in right atrium|
16145795|NCT01814215|Behavioral|Keys to Healthy Family Child Care Homes|The Keys to Healthy Family Child Care Homes intervention will be delivered to providers via a health behavior coach using a consistent structure and sequence of coaching contacts, including an introductory self-assessment, hands-on workshops, on-site home visits with goal setting and action planning, follow-up coaching phone calls using Motivational Interviewing-inspired techniques, and supportive print toolkit materials.
16145796|NCT01814202|Other|PTM202|
16145797|NCT01814202|Other|Placebo|
16145798|NCT01814189|Drug|Sumatriptan+Promethazine (SPr)|
16145799|NCT01814176|Device|Intubation with GlideScope Video Laryngoscope or Macintosh Direct Laryngoscope|
16145800|NCT01814163|Drug|paclitaxel, carboplatin and bevacizumab|Paclitaxel 200 mg/m2, carboplatin area under curve (AUC) 6 mg/ml/min plus bevacizumab 15 mg/kg on day 1, every 21 days. Total number of cycles: 6. After 6 cycles bevacizumab on monotherapy until progression
16145801|NCT01814137|Drug|insulin degludec/insulin aspart|For subcutaneous (s.c., under the skin) administration twice daily in combination with up to 2 oral antidiabetic drugs (OADs- dose and dosing frequency of OAD should remain unchanged).
16145802|NCT01814137|Drug|insulin degludec|For subcutaneous (s.c., under the skin) administration once daily in combination with up to 2 oral antidiabetic drugs (OADs- dose and dosing frequency of OAD should remain unchanged).
16145803|NCT01814137|Drug|insulin aspart|For subcutaneous (s.c., under the skin) administration once daily. Dose of IDegAsp and IAsp are individually adjusted.
16145804|NCT01814137|Drug|insulin aspart|For subcutaneous (s.c., under the skin) administration three times a day. Dose of IDeg and IAsp are individually adjusted.
16145805|NCT01814124|Other|Manual therapy plus exercise|
16145806|NCT01814124|Other|Advice and home exercise|
16145807|NCT01814111|Procedure|renal sympathetic denervation|The ablation catheter was maneuvered within the renal artery to allow energy delivery in a circumferential, longitudinally staggered manner to minimize the chance of renal artery stenosis.
16145808|NCT01814098|Drug|Escitalopram|Escitalopram tablets will be administered orally at 10 milligram per day (mg/day). The dose may be increased to maximum of 20 mg/day depending on Investigators discretion for 24 weeks
16145809|NCT01814085|Drug|Escitalopram|Escitalopram tablets will be administered orally in the dose range of 10 to 20 milligram per day (mg/day) for 8 weeks. Dose can be adjusted as per Investigator's discretion depending on participant's response.
16145810|NCT01814072|Behavioral|12 Telephone Coaching Sessions|Participants will receive 12 telephone coaching sessions
16145811|NCT01814072|Behavioral|24 Telephone Coaching Sessions|Participants will receive 24 telephone coaching sessions
16145812|NCT01814072|Behavioral|Report to Primary Care Physician|Participants will have a report detailing their weight loss progress sent to their primary care physician
16145813|NCT01814072|Behavioral|Text Messages|Participants will receive regular text messages
16145814|NCT01814072|Behavioral|Recommendations to use meal replacements|Participants will receive recommendations from their coach to use meal replacements
16145815|NCT01814072|Behavioral|Buddy Training|Participants will have a buddy that will be trained via webinars to be a supportive buddy
16145816|NCT01814059|Drug|sirolimus|
16145817|NCT01814046|Drug|Aldesleukin|Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses) (only for cohort A).
16145818|NCT01814046|Drug|Cyclophosphamide|Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
16145819|NCT01814046|Drug|Fludarabine|Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
16145820|NCT01814046|Biological|Young Tumor Infiltrating Lymphocytes (TIL)|Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL and high dose aldesleukin (Cohort A) or no aldesleukin (Cohort B). On day 0,cells (1x10e9 to 2x10e11) will be infused intravenously on the Patient Care Unit over 20-30 minutes.
16145821|NCT01814033|Other|Experimental: LRU Pillow|Foam wedge with a trough for positioning of the lower leg in an elevated position.
16145822|NCT01814033|Other|Control Group|Standard bed pillows placed under the lower leg to facilitate elevation
16145823|NCT01814020|Drug|MOB015B|
16145824|NCT01814007|Device|The Zeltiq CoolSculpting System|Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
16145825|NCT01813994|Drug|Arm1: Statin|"Study1 (only H. pylori infected patients) Arm1: All patients undergo H. pylori eradication therapy after 2 weeks from the endoscopic submucosal dissection. In this arm2, all patients take statins for 6 months. Then, follow-up endoscopy for gastric biopsy and CLO test will be performed after 6.5 months from the endoscopic submucosal dissection.
~Study2 (only H. pylori non-infected patients) Arm1: In this arm2, all patients start taking statins after 2 weeks from the endoscopic submucosal dissection. Follow-up endoscopy for gastric biopsy will be performed after 6.5 months from the endoscopic submucosal dissection."
16145860|NCT01813708|Behavioral|Intensive Life-Style|16 weekly sessions conducted by certified nutritionists certified in behavioural modification, and self-care techniques, including self-monitoring, healthy nutrition, physical activity, problem solving, relapse prevention, self-reinforcement, long-term motivation, and stress management
16145826|NCT01813994|Drug|Arm2: Placebo|"Study1 (only H. pylori infected patients) Arm2: All patients undergo H. pylori eradication therapy after 2 weeks from the endoscopic submucosal dissection. In this arm2, all patients take placebos for 6 months. Then, follow-up endoscopy for gastric biopsy and CLO test will be performed after 6.5 months from the endoscopic submucosal dissection.
~Study2 (only H. pylori non-infected patients) Arm2: In this arm2, all patients start taking placebos after 2 weeks from the endoscopic submucosal dissection. Follow-up endoscopy for gastric biopsy will be performed after 6.5 months from the endoscopic submucosal dissection."
16145827|NCT01813981|Dietary Supplement|Low roast coffee|Instant coffee
16145828|NCT01813981|Dietary Supplement|High roast coffee|Instant coffee
16145829|NCT01813981|Dietary Supplement|Control (Caffeine dissolved in water)|Caffeine dissolved in water
16145830|NCT01813968|Procedure|Ischemic postconditioning|
16145831|NCT01813955|Drug|Papaverine or placebo|Papaverine delayed release (depot capsule, 300 mg, orally, one single dosage per subject) or placebo
16145832|NCT01813929|Drug|Metformin|Six week intervention: Study drug/placebo will be given in a forced uptitration with 500 mg once daily for one week, 500 mg twice daily for one week, 500/1000 for one week, and then 1000mg twice daily for the remainder of the 6 week intervention. If uptitration is not tolerated, max dose will be max tolerated dose of at least 500 mg twice daily.
16145833|NCT01813929|Drug|Placebo|Six-week intervention: Study drug/placebo will be given in a forced uptitration with 500 mg once daily for one week, 500 mg twice daily for one week, and then the higher dose (850 mg) for the remainder of the 6 week intervention.
16145834|NCT01813916|Other|proteomic analysis|
16145835|NCT01813903|Behavioral|Intensified dietary counseling|The intervention is completed by public health nurses who will be trained to provide family-centered empowering and motivational lifestyle counseling at the normal health check visit. Parents expecting child will use web application developed for nutritional counseling. Web application consists of dietary questionnaire from which the parents will receive immediately automatic feedback. Feedback concerns the quality of diet in relation to the Finnish nutrition recommendations. Feedback will be given in an encouraging format. Own targets of food changes can also be recorded in the application, and the application can be used to monitor how they are achieved.
16145836|NCT01813903|Behavioral|Mobile application|Mothers expecting child will use mobile application. Mobile application consists of text, audio and video exercises, which are aimed to increase the psychological flexibility and thus mental and physical well-being.
16145837|NCT01813890|Drug|Tapentadol IR 50 mg|Tapentadol IR 50 mg will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period.
16145838|NCT01813890|Drug|Tapentadol IR 75 mg|Tapentadol IR 75 mg will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period.
16145839|NCT01813890|Drug|Placebo|Placebo will be administered as a single oral dose once every 4 to 6 hours, during the double blind treatment period.
16145840|NCT01813877|Radiation|FDOPA PET/CT|Positron emission tomography (PET) is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of substances (tracers) that are injected via a hand or arm vein. These substances can track certain features of cancers that can be visualized by using the PET/CT scanner, in this instance the amino acid 18F-DOPA.
16145841|NCT01813864|Behavioral|CASPAR/Treatment Planning|All counselors in the study will receive additional training in treatment planning and the CASPAR Resource Guide software to easily identify and link patients to services not available at substance abuse treatment centers such as General Educational Development (GED) training, dental clinics, job training, etc.
16145842|NCT01813851|Device|Exercise training in addition to nutritional support|
16145843|NCT01813838|Drug|ACADESINE 140mg/kg/d|"3 patients will be included at the initial dose of 140mg/kg/d. In absence of toxicity, 3 additional patients will be included at the higher dosage.
~In case of 1/3 toxicity, 3 additionnal patients will be included at the same dose level, currently 140mg/kg/d.
~In case of toxicity in 2 or more patients, the dose of acadesine will be reduced at the the dose of 85mg/kg/d"
16145844|NCT01813838|Drug|ACADESINE 210mg/kg/d|"3 patients will be included at the dose of 210mg/kg/d. In absence of toxicity, 3 additional patients will be included at the higher dosage.
~In case of 1/3 toxicity, 3 additionnal patients will be included at the same dose level, currently 210mg/kg/d.
~In case of toxicity in 2 or more patients, the dose of acadesine will be reduced at the the dose of 140mg/kg/d"
16145845|NCT01813838|Drug|ACADESINE 315mg/kg/d|"3 patients will be included at the dose of 315mg/kg/d.
~In case of 1/3 toxicity, 3 additionnal patients will be included at the same dose level, currently 315mg/kg/d.
~In case of toxicity in 2 or more patients, the dose of acadesine will be reduced at the the dose of 210mg/kg/d"
16145846|NCT01813825|Other|Registry|
16145847|NCT01813812|Drug|DA-6034|
16145848|NCT01813812|Drug|Rebamipide 300mg|
16145849|NCT01813799|Drug|DA-9801 300mg|300mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
16145850|NCT01813799|Drug|DA-9801 600mg|600mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
16145851|NCT01813799|Drug|DA-9801 900mg|900mg of DA-9801 tablet is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
16145852|NCT01813799|Drug|Placebo|Placebo is assigned at week 0 point and is taken for 8 continuous weeks, 3 times a day.
16145853|NCT01813786|Device|755nm Alexandrite Laser with handpiece 2|Focusing energy on skin
16145854|NCT01813786|Device|755nm Alexandrite Laser with handpiece 1|focusing energy at skin surface
16145855|NCT01813786|Device|755nm Alexandrite Laser with handpiece 3|Focusing energy on skin
16145856|NCT01813773|Drug|Intravitreal Aflibercept Injection (IAI)|EYLEA (aflibercept) is a recombinant fusion protein consisting of portions of human VEGF receptors 1 and 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. Aflibercept is a dimeric glycoprotein with a protein molecular weight of 97 kilodaltons (kDa) and contains glycosylation, constituting an additional 15% of the total molecular mass, resulting in a total molecular weight of 115 kDa. Aflibercept is produced in recombinant Chinese hamster ovary (CHO) cells.
16145857|NCT01813760|Device|Illuiminage ® Diode Laser|Diode laser for treatment of peri-orbital and peri-oral wrinkles
16145858|NCT01813747|Device|1440 nm wavelength laser with handpiece (Cynosure)|To assess the effectiveness of device in skin tightening and laser lipolysis in the mandibular and sub-mandibular areas.
16145861|NCT01813708|Behavioral|Collaborative Education|16 weekly sessions conducted by certified diabetes educators including: diabetes knowledge, nutrition, exercise, goal establishment in diabetes, problem solving, relapse prevention, self-monitoring, family and sexuality in diabetes, emotional management in diabetes, and stress management. Patients established their own goals
16145862|NCT01813695|Procedure|Preemptive genotyping in medical record|
16145863|NCT01813695|Procedure|Genotyping not included in electronic medical record|
16145864|NCT01813682|Other|treatment group1|fe-1 group with TPN of iron supplementation of 200μg/kg/d.
16145865|NCT01813682|Other|treatment group2|fe-2 group with TPN of iron supplementation of 400μg/BW (BW=birth weight)
16145866|NCT01813669|Behavioral|Integrative Coping Group|"The proposed 12-week intervention will integrate yoga-based skills with cognitive-behavioral principles. The development of this program was based on existing and empirically-validated cognitive-behavioral interventions for youth (i.e., Coping Cat and Cat Project; Kendall et al.) and therapeutic yoga interventions (e.g., Galantino et al., 2008 for review). The intervention will be broken down into four three-week modules, which address the following:
~Module 1: Introduction to group and awareness of body Module 2: Awareness of emotion and developing an understanding of the mind-body connection Module 3: Focus on cognitive process Module 4: Experiential practice and therapeutic discussions"
16145867|NCT01813656|Drug|Aripiprazole|Aripiprazole group,5mg/pill,10mg/day non-forced titration method,last 12weeks
16145868|NCT01813656|Drug|placebo|placebo group,5mg/pill,10mg/day non-forced titration method,last 12 weeks
16145869|NCT01813643|Drug|Risperidone|Risperidone group,1mg/pill,2mg-6mg/day non-forced titration method,last 2-4weeks
16145870|NCT01813643|Drug|Aripiprazole|Aripiprazole group,5mg/pill,20mg-30mg/day non-forced titration method,last 2-4weeks
16145871|NCT01813630|Drug|DA-3002|
16145872|NCT01813630|Drug|Genotropin®|
16145873|NCT01813617|Drug|Immunosuppressive Agents|Patients in the cohort received medical treatment according to standard care.
16145874|NCT01813604|Biological|Group A: Trivalent Oral Polio Vaccine|Group A will receive 3 doses of trivalent oral polio vaccine (tOPV) at 6, 10 and 14 weeks of age. A challenge dose of tOPV will be administered at 18 weeks of age.
16145875|NCT01813604|Biological|Group B: Bivalent Oral Polio Vaccine|Group B will receive 3 doses of bivalent oral polio vaccine (bOPV) at 6, 10 and 14 weeks of age. A challenge dose of tOPV will be administered at 18 weeks of age.
16145876|NCT01813604|Biological|Group C: Inactivated Polio Vaccine|Group C will receive 2 doses of inactivated polio vaccine (IPV) at 6 and 14 weeks of age. IPV will be administered intramuscularly using standard needle and syringe. A challenge dose of tOPV will be administered at 18 weeks of age.
16145877|NCT01813604|Biological|Group D: fractional IPV (f-IPV)|Group D will receive 2 doses of fractional inactivated polio vaccine (f-IPV) at 6 and 14 weeks of age. f-IPV (one-fifth dose of IPV) will be administered intradermally using MicroJet 600 microneedle hub by NanoPass Technologies. A challenge dose of tOPV will be administered at 18 weeks of age.
16145878|NCT01813604|Biological|Arm E: f-IPV and bOPV|Group E will receive 2 doses of f-IPV at 6 and 14 weeks of age with bOPV at 10 weeks of age. f-IPV will be administered intradermally using MicroJet 600 microneedle hub by NanoPass Technologies. A challenge dose of tOPV will be administered at 18 weeks of age.
16145879|NCT01813591|Drug|H.P. Acthar Gel|Acthar (40IU or 80IU) given subcutaneously for 5 days in the 1st week, followed by every other day (3 times per week for the next 3 weeks)
16145880|NCT01813578|Other|Exercise|Intensive aerobic and muscle endurance exercise
16145881|NCT01813565|Drug|Hyaluronic acid/chondroitin sulfate|Additional Hyaluronic acid/chondroitin sulfate instillation to the bladder
16145882|NCT01813552|Drug|Samatasvir|Samatasvir 150 mg oral tablets (50mg x 3), single dose
16145883|NCT01813552|Drug|Omeprazole|40 mg delayed-release oral capsules, once daily
16145884|NCT01813552|Drug|Ritonavir|100 mg oral tablets, once daily
16145885|NCT01813539|Drug|ARGX-110|ARGX-110 will be administered as an IV infusion.
16145886|NCT01813526|Other|Experimental Infant Formula|Nutritionally complete free amino acid-based medical food.
16145887|NCT01813513|Drug|IDX719|50 mg tablet for oral administration
16145888|NCT01813513|Drug|Simeprevir|150 mg capsule for oral administration
16145889|NCT01813500|Other|Blood and stool sample|Subjects are asked to provide a blood sample (6 to 10cc) and a stool sample. An additional blood sample will be requested if the subject has a flare.
16145890|NCT01813487|Drug|HBsAg vaccine with Entecavir|
16145891|NCT01813474|Drug|olaparib|tablet oral
16145892|NCT01813461|Drug|14C-labeled prodrug isavuconazonium sulfate|oral
16145893|NCT01813448|Drug|Fidaxomicin|oral
16145894|NCT01813448|Drug|Placebo|oral
16145895|NCT01813435|Drug|Ticagrelor|Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy.
16145896|NCT01813435|Drug|Acetylsalicylic Acid|Comparison of 1 month of ticagrelor and aspirin followed by 23 months of ticagrelor monotherapy versus 12 months of standard dual anti platelet therapy (DAPT) followed by aspirin monotherapy
16145897|NCT01813435|Drug|Clopidogrel|"Active Comparator: Reference treatment strategy Acute Coronary Syndrome (ACS) patients incl. unstable angina (UA) patients: ASA and Brilique(ticagrelor) for 12 months followed by 12 months of ASA monotherapy.
~Stable Coronary Artery Disease (CAD) patients: ASA and clopidogrel for 12 months followed by 12 months of ASA monotherapy"
16145898|NCT01813422|Biological|Evolocumab|Administered by subcutaneous injection
16145899|NCT01813422|Drug|Placebo|Administered by subcutaneous injection
16145900|NCT01813396|Other|joint mobilization plus massage|
16145901|NCT01813396|Other|joint mobilization/shoulder physical activity guide|
16145902|NCT01813383|Other|There is not any intervention|
16145903|NCT01813370|Other|No intervention|No intervention is planned as part of this protocol. Historical data will be transferred to MSK via electronic data transfer. Patient's PSA, testosterone, and vital status data will be transferred to MSK via electronic data transfer.
16145904|NCT01813357|Drug|Rosuvastatin|encapsulated tablet 20mg daily
16145905|NCT01813357|Other|Placebo|Placebo arm included to maintain blinding
16145943|NCT01813045|Procedure|Cardiac MRI scan|Cardiac MRI scan with assessment of late gadolinium enhancement and T1 mapping.
16145906|NCT01813318|Drug|Acamprosate|The maximum dose of acamprosate to be used in this study is 1998 mg per day for those subjects weighing greater than 50kg and 1332 mg per day for those less weighing less than 50kg.
16145907|NCT01813318|Drug|Placebo|Subjects receiving placebo will be dosed similarly to the acamprosate group.
16145908|NCT01813305|Drug|CSTC1|vapor fraction from seeds of Glycine max (L.) Merr. and composition thereof
16145909|NCT01813305|Drug|CSTC1 Matched vehicle|
16145910|NCT01813279|Other|the cell therapy|the reinjection of autologous stromal vascular fraction of adipose tissue issue on the fingers of patients with scleroderma.
16145911|NCT01813253|Drug|Irinotecan|150 mg/m2 IV once every 2 weeks until progression or unacceptable toxicity develops
16145912|NCT01813253|Drug|Nimotuzumab|400mg IV once weekly until progression or unacceptable toxicity develops
16145913|NCT01813240|Drug|Minocycline|
16145914|NCT01813240|Drug|placebo|
16145915|NCT01813227|Drug|Carfilzomib|If you decide to participate in the study, you will receive carfilzomib on Days 1, 2, 8, 9, 15, and 16 every 28 days for a minimum of 2 cycles (approximately 2 months). You may receive additional cycles for as long as your disease remains stable or improved or until your study doctor determines that you should stop receiving the study drug or you decide to stop participating in the study.
16145916|NCT01813227|Drug|Rituximab|"If you decide to participate in the study, in addition to the carfilzomib and possible dexamethasone administration, If less than a partial remission (PR) after 4 cycles is achieved, rituximab 375 mg/m2 on day 16 of each subsequent cycle will be added to the treatment. Subjects who meet the criteria for progression prior to 4 cycles of therapy will have rituximab 375 mg/m2 weekly for 4 consecutive weeks every 3 cycles added to the treatment. Subjects will be treated to maximal response plus 2 additional cycles to a maximum of 12 cycles.
~At the beginning of every cycle, your study doctor will see if your general health is satisfactory. You will be asked to report any side effects or problems you have had since the start of the last treatment cycle as well as any medication change(s)."
16145917|NCT01813227|Drug|Dexamethasone|"If you decide to participate in the study, you will receive carfilzomib on Days 1, 2, 8, 9, 15, and 16 every 28 days for a minimum of 2 cycles (approximately 2 months). You may receive additional cycles for as long as your disease remains stable or improved or until your study doctor determines that you should stop receiving the study drug or you decide to stop participating in the study.
~You will also receive dexamethasone weekly on Days 1, 2, 8, 9, 15 and 16 starting with cycle 1 and continuing every cycle thereafter."
16145918|NCT01813214|Drug|Vemurafenib|
16145919|NCT01813214|Drug|Cobimetinib|
16145920|NCT01813201|Drug|Testosterone undecanoate|Testosterone undecanoate intramuscular long-acting, 1000 mg/dose, administered at inclusion and every 12 weeks for 9 months (4 dose) (testosterone group) against the administration of placebo (saline isotonic solution).
16145921|NCT01813201|Drug|Saline isotonic solution|Saline isotonic solution (placebo)intramuscular,administered at inclusion and every 12 weeks for 9 months (4 dose)
16145922|NCT01813188|Procedure|ABM seeded onto a porous TCP and DBM|"cells collection under sedation . 114 mL are obtained and processed through a ficoll gradient.
~Autologous bone marrow (ABM) cells seeded onto a porous tricalcium phosphate ceramic (TCP) and demineralized bone matrix (DBM)"
16145923|NCT01813188|Procedure|autologous bone graft|autologous bone graft
16145924|NCT01813175|Other|Regular non-hydrolysed cow's milk I|Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture I
16145925|NCT01813175|Other|Regular non-hydrolysed cow's milk II|Regular non-hydrolysed cow's milk based infant formula with synbiotics mixture II
16145926|NCT01813175|Other|Regular non-hydrolysed cow's milk - control|Regular non-hydrolysed cow's milk based infant formula without synbiotics mixture
16145927|NCT01813162|Drug|Tenofovir 1% gel|
16145928|NCT01813162|Drug|Vaginal product|
16145929|NCT01813149|Drug|phenylephrine and clonidine|Subjects will be injected with phenylephrine and clonidine at both affected and unaffected sites.
16145930|NCT01813149|Other|punch biopsy|
16145931|NCT01813136|Drug|Continuous pazopanib (Arm A)|Daily oral administration of pazopanib 800mg (28 days cycles) from randomization until progression (according to RECIST 1.1) under treatment, after an initial period of 6 cycles (28 days) of daily administration of pazopanib 800mg from inclusion until randomization
16145932|NCT01813136|Drug|Intermittent pazopanib (Arm B)|"Temporary discontinuation of pazopanib at randomization, after an initial period of 6 cycles (28 days) of daily administration of pazopanib 800mg from inclusion until randomization. Pazopanib will be reintroduced for 6 cycles of 28 days, with daily administration of pazopanib 800mg, as soon as the patient relapses (progressive disease according to RECIST 1.1). At the end of this additional 6 cycles, study drug will be stopped a second time.
~This sequential scheme will be maintained until the patient experiences on-treatment progression"
16145933|NCT01813123|Behavioral|RealTeen|A web-based, gender-specific program intended improve girls' cognitive and behavioral skills. Each of the 9 sessions requires approximately 20 minutes. After initial intervention, girls will receive two annual booster sessions (i.e., a 20-minute review of previously learned material indexed to new age).
16145934|NCT01813110|Drug|4 g prescription omega-3 concentrate|4 g/d prescription omega-3 fatty acid concentrate taken orally for 8-12 weeks
16145935|NCT01813110|Drug|Placebo|olive oil
16145936|NCT01813084|Drug|RV1729 single dose|Safety and tolerability of single escalating doses
16145937|NCT01813084|Drug|RV1729 matching placebo single dose|Safety and tolerability of single escalating doses
16145938|NCT01813084|Drug|RV1729: 14 day repeat dose|Safety and tolerability of repeat escalating doses
16145939|NCT01813084|Drug|RV1729 matching placebo: 14 day repeat dose|Safety and tolerability of repeat escalating doses
16145940|NCT01813071|Biological|WRSS1|
16145941|NCT01813058|Drug|Tranexamic Acid|"Following a standardized general anesthetic protocol, patients coming with idiopathic scoliosis will be randomized to either:
~placebo i.e. saline 0.9% (intravenous injection)
~intravenous TXA given as a loading dose over 15 minutes of 50 mg/kg bolus ( within an hour prior to surgical incision) and 10 mg/kg/hr infusion for the duration of the surgery."
16145942|NCT01813058|Drug|Placebo|"Following a standardized general anesthetic protocol, patients coming with idiopathic scoliosis will be randomized to:
~Placebo ( 0.9% Normal saline) intravenously given as a 0.5 ml/kg loading dose over 15 minutes followed by a 0.1 ml/kg/hr continuous infusion throughout the surgery or
~TXA as previously described."
16145944|NCT01813045|Radiation|CT-PET scan|Computed Tomography / Positron Emission Tomography scan with 18F-fluciclatide tracer.
16145945|NCT01813045|Radiation|CT-coronary angiogram|CT-coronary angiogram following CT-PET scan. Standard protocol.
16145946|NCT01813032|Procedure|Forearm Vascular Study|Forearm venous occlusion plethysmography to measure forearm blood flow during intra-arterial infusion of the vasodilators Verapamil (10-100 µg/min), bradykinin (100-1000 pmol/min), sodium nitroprusside (2-8 µg/min) and Acetylcholine (5-20 µg/min).
16145947|NCT01813032|Procedure|Badimon Chamber|Ex-vivo assessment of thrombus formation using the Badimon Chamber
16145948|NCT01813019|Drug|AFQ056|mGluR5 antagonist
16145949|NCT01813019|Drug|Placebo|Matched placebo
16145950|NCT01813006|Drug|Omega-3|
16145951|NCT01813006|Drug|placebo|
16145952|NCT01812993|Device|Non-invasive ventilatory treatment with auto-BPAP|
16145953|NCT01812980|Biological|Trivalent Inactivated Influenza Vaccine|"WHO recommendation for influenza vaccines for 2013 for the Southern-hemisphere included the following vaccine strains:
~an A/California/7/2009 (H1N1)pdm09-like virus;
~an A/Victoria/361/2011 (H3N2)-like virus; - a B/Wisconsin/1/2010-like virus."
16145954|NCT01812967|Dietary Supplement|Milk Fat|
16145955|NCT01812967|Dietary Supplement|Milk Protein|
16145956|NCT01812967|Dietary Supplement|Lactose|
16145957|NCT01812967|Other|Whole milk (3.25% M.F.(|Commercially available milk from the grocery store
16145958|NCT01812967|Dietary Supplement|Simulated Milk Beverage|Added lactose + fat + protein together to form a mixture
16145959|NCT01812954|Drug|Methotrexate|
16145960|NCT01812954|Drug|Cyclosporins|
16145961|NCT01812954|Drug|fumaric acid|
16145962|NCT01812954|Drug|Acitretin|
16145963|NCT01812954|Drug|Infliximab|
16145964|NCT01812954|Drug|etanercept|
16145965|NCT01812954|Drug|Adalimumab|
16145966|NCT01812954|Drug|Ustekinumab|
16145967|NCT01812941|Other|trauma: blood collection|Blood samples collected at certain timepoints. Time points for burn/trauma subjects: Day0,Day1,Day2,and Day6 and Day7.
16145968|NCT01812941|Other|healthy volunteers: blood collection|blood collected at designated time intervals
16145969|NCT01812941|Other|Burn: blood collection|blood collected at designated time intervals
16145970|NCT01812928|Drug|Diclofenac|
16145971|NCT01812915|Device|Cylindrical-shape cuff ETT (Group C)|Randomized allocation of the endotracheal cuffs for general anesthesia, mechanical ventilation will be maintained with Mallinckrodt Hi-Lo(TM) endotracheal tube.
16145972|NCT01812915|Device|Tapered-shape cuff ETT (Group T)|Randomized allocation of the endotracheal cuffs for general anesthesia, mechanical ventilation will be maintained with Mallinckrodt TaperGuard(TM) endotracheal tube.
16145973|NCT01812902|Procedure|Radical Prostatectomy|
16145974|NCT01812889|Drug|TOL-463 Vaginal ovule|TOL-463 Vaginal Ovule
16145975|NCT01812889|Drug|TOL-463 Vaginal gel|TOL-463 Vaginal Gel
16145976|NCT01812863|Procedure|Supraclavicular nerve block|"Following injection of morphine, an ultrasound-guided supraclavicular nerve catheter (Angiocath) will be placed in Group 2. All catheters will be placed by one of the anesthesiologist trained in regional pain control using a 25 mm linear US probe in a sterile fashion.
~If the examination is unchanged from preoperative assessment, an injection block using 5 ml of 0.25% bupivacaine with 1:200,000 epinephrine will be administered. Bupivacaine is a long acting local anesthetic that prevents nerve conduction and action potential initiation by decreasing the permeability of the neuronal membrane to sodium. We use a maximum dose of 5 mL of 0.25% bupivacaine, and we usually base the dose on a ml/kg (0.2 ml/kg) with a maximum dose not to exceed 2.5 mg/kg. This will be well below toxic levels."
16145977|NCT01812837|Device|Microneedle|The study device (Microchannel Skin System by 3M Company)is fabricated from medicalgrade polymer consisting of a rectangular array of 351 pyramidal, 700-μm-long, solid microneedles.
16145978|NCT01812837|Drug|Aminolevulinic Acid|Levulan® Kerastick® DUSA Pharmaceuticals, Inc., Wilmington, MA
16145979|NCT01812837|Radiation|Blue light|Blu-U unit (DUSA Pharmaceuticals, Inc., Wilmington, MA)
16145980|NCT01812824|Behavioral|Intervention (Virtual Patient Advocate)|"Intervention (Virtual Patient Advocate) participants will have access to the Gabby system for 6 months. There is no required dose or frequency that they have to log on to the system, but the investigators will suggest that they log on once a week."
16145981|NCT01812798|Other|Double Blind Placebo Controlled Food Challenge|"All participants will undergo Double Blind Placebo Controlled Food Challenge. Participants will be randomized to receive either Peanut on Day 1, Placebo on Day 2, or vice versa.
~For 'Peanut' arm, participants will be fed increasing doses of peanut until mild objective allergic reaction is observed.
~Doses will be increased every 20-30 minutes. All doses are listed in g peanut flour
~0.1 0.25 0.5 0.75
~1 2.5 5 10 25 50 100 250 500 750 1000 2500 5000
~For Placebo arm, participants will be fed increasing amounts of food matrix without peanut flour."
16145982|NCT01812772|Device|Double J-stent with a long tether|Patients will receive a double-J stent placement with a long tether following ureteroscopy.
16145983|NCT01812772|Device|Double J-stent without a long tether|Patients will receive a double-J stent placement without a long tether following ureteroscopy.
16145984|NCT01812759|Drug|Fentanyl Nasal Spray|100 mcg nasal spray administered in each nostril.
16145985|NCT01812759|Drug|Hydromorphone PCA|Initial loading dose 0.2 mg with demand doses of 0.2 mg and lockout interval of 15 minutes. There will be no basal dose and the 8-hour dose limit will be 6.4 mg.
16145986|NCT01812759|Other|Placebo Nasal Spray|1 placebo nasal spray administered in each nostril.
16145987|NCT01812746|Drug|BIND-014|
16145988|NCT01812720|Drug|carfilzomib|Given IV
16145989|NCT01812720|Drug|dexamethasone|Given PO
16145990|NCT01812720|Other|laboratory biomarker analysis|Correlative studies
16145991|NCT01812707|Drug|Alirocumab|Two SC injections in the abdomen only
16145992|NCT01812707|Drug|Placebo (for alirocumab)|"Two subcutaneous (SC) injections in the abdomen only
~Route of administration: subcutaneous injection (1 mL) in the abdomen"
16145993|NCT01812707|Drug|Atorvastatin|"Orally once daily at a stable dose of 5 to 20 mg as background therapy
~Route of administration: oral administration in the evening"
16145996|NCT01812668|Drug|cabozantinib-s-malate|Given PO
16145997|NCT01812668|Radiation|fluorine F 18 d-FMAU|Undergo 18F PET/FMAU PET scan
16145998|NCT01812668|Procedure|positron emission tomography|Undergo 18F PET/FMAU PET scan
16145999|NCT01812668|Other|pharmacological study|Correlative studies
16146000|NCT01812668|Other|laboratory biomarker analysis|Correlative studies
16146001|NCT01812655|Device|Virtual Reality|
16146002|NCT01812655|Other|Passive Distraction|
16146003|NCT01812642|Drug|JNJ-37822681|JNJ-37822681 oral capsule will be administered at a starting dose of either 20 mg (once daily) or 10 milligram (twice daily) for 14 days.
16146004|NCT01812642|Other|Placebo|Matching Placebo will be administered orally, once daily in the evening (12 hour after JNJ-37822681 20 mg administration) for 14 days.
16146005|NCT01812629|Other|Experimental Infant Formula|Infant formula to be fed ad libitum
16146006|NCT01812616|Drug|Sativex|Administered orally as a spray to the cheek according to a standard dose titration regimen, until patients reach a maximum tolerated dose (maximum 12 sprays per day). Each spray delivers 100 μl (Δ9tetrahydrocannabinol (THC), 27 mg/ml: Cannabidiol (CBD), 25 mg/ml).
16146007|NCT01812616|Drug|Placebo|Administered orally as a spray to the cheek according to a standard dose titration regimen, until patients reach a maximum tolerated dose (maximum 12 sprays per day). Each spray delivers 100 μl ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring and Food, Drugs & Cosmetics (FD&C)certified color additives; FD&C Yellow No.5 (E102 tartrazine) (0.0260%), FD&C Yellow No.6 (E110 sunset yellow) (0.0038%), FD&C Red No. 40 (E129 Allura red AC) (0.00330%) and FD&C Blue No.1 (E133 Brilliant blue FCF) (0.00058%).
16146008|NCT01812603|Drug|Sativex|Administered orally as a spray to the cheek according to a standard dose titration regimen, until patients reach a maximum tolerated dose (maximum 12 sprays per day). Each spray delivers 100 μl (Δ9tetrahydrocannabinol (THC), 27 mg/ml: Cannabidiol (CBD), 25 mg/ml).
16146009|NCT01812590|Behavioral|Exercise|
16146010|NCT01812564|Biological|Platelet Poor Plasma (PPP)|
16146011|NCT01812564|Biological|Platelet Rich Plasma (PRP)|
16146012|NCT01812551|Drug|Alendronate|As active drug, we used Alendros (Abiogen Pharma, Pisa, Italy), distributed to the patients in plain bottles and boxes (bearing only the center and patient codes).
16146013|NCT01812551|Drug|Placebo|Placebo was distributed to the patients in plain bottles and boxes (bearing only the center and patient codes).
16146014|NCT01812538|Drug|DIC075V|"Four single dose treatments:
~Placebo (normal saline)
~Moxifloxacin (positive control)
~DIC075V 37.5 mg
~DIC075V 75 mg
~All subjects receive each of the 4 treatments."
16146015|NCT01812525|Drug|NaCl 3%|NaCl 3%: 4ml QID
16146016|NCT01812525|Other|Standard therapy|Standard therapy includes suctioning nasal secretions, water-electrolyte balance maintenance and oxygen supplementation when needed
16146017|NCT01812512|Behavioral|Teaching for Interactive Patient Self-Management (TIPS) for Heart Failure (HF|The curriculum plan adapts components from the Rochester Participatory Decision-Making Scale (RPAD) and recent advances in communication skills training for chronic disease to develop a valid and reliable intervention specific to Home Telehealth (HT) shared decision making, effective telehealth communication, and patient self-management for heart failure (HF), using established best-practices and Veteran input. Veteran volunteers will participate in video recorded simulations to promote nurse care coordinator (NCC) active participation and problem-solving during the course. Scenarios are taken from transcribed actual HT interactions from the first exploratory RRP study of HT. The course is set up as one live session, one online module, and a final live session for more difficult conversations.
16146018|NCT01812486|Radiation|dose de escalation|
16146019|NCT01812486|Radiation|standard dose|
16146020|NCT01812473|Other|Blood sampling|During the treatment of voriconazole, at steady plasma concentrations of voriconazole, one plasma sample and one serum sample are taken.
16146021|NCT01812460|Other|Intervention-training-group|As descriped in Arm Description
16146022|NCT01812447|Device|Spiration Valve System|Subjects assigned to the treatment group will undergo a bronchoscopic procedure to have valves placed in the most diseased lobe of the lung to occlude all segments of the lobe.
16146023|NCT01812447|Other|Medical Management|Stable management is based on the ACP/ACCP/ATS/ERS Guidelines for Management of Stable COPD. Medical management will include management of COPD medications, oxygen use, and pulmonary rehabilitation.
16146024|NCT01812434|Drug|Sildenafil|20mg three time daily for 28 days
16146025|NCT01812434|Drug|Placebo|20 mg three times daily for 28 days
16146026|NCT01812421|Other|Hypertension Health Education Protocol (HHEP)|
16146027|NCT01812395|Device|Thyroidectomy using harmonic focus (r)|Harmonic focus(r) device is used to seal and cut the vessels during thyroidectomy.
16146028|NCT01812395|Procedure|Conventional thyroidectomy|Vessels are ligated with sutures then cut using classic scalpel or scissors.
16146029|NCT01812382|Drug|Retapamulin Microdialysis|After a 30 minutes equilibration period of the microdialysis procedure/infusion with normal saline solution, 50nanogram (ng)/mL Retapamulin injectable solution will be infused at a flow rate of 1.5 microliter/minute over a period of 90 minutes. The total dose perfused for each of the 3 microdialysis tubes will be 6.75ng.
16146030|NCT01812369|Drug|GEMCITABINE CISPLATINE|
16146031|NCT01812369|Drug|METHOTRXATE VINBLASTINE DOXORUBICINE CISPLATINE G-CSF|
16146032|NCT01812356|Device|Cryomaze procedure using Nitrous oxide|Cryomaze procedure using Nitrous oxide
16146033|NCT01812356|Device|Cryomaze procedure using Argon|Cryomaze procedure using Argon
16146034|NCT01812343|Other|Exercise test|
16146035|NCT01812330|Drug|Clopidogrel|After 600mg loading dose, 75mg or 150mg Qd
16146036|NCT01812330|Drug|Ticagrelor|90mg Bid
16146037|NCT01812317|Procedure|Forearm Vascular Study|Forearm venous occlusion plethysmography to measure forearm blood flow during intra-arterial infusion of the vasodilators Verapamil (10-100 µg/min), bradykinin (100-1000 pmol/min), sodium nitroprusside (2-8 µg/min) and Acetylcholine (5-20 µg/min).
16146038|NCT01812317|Procedure|Badimon Chamber Study|Ex-vivo assessment of thrombus formation using the Badimon Chamber
16146039|NCT01812304|Other|hands-on training|the intervention consists of a predefined hands-on training program including 25 technical steps to manage a vaginal breech
16146040|NCT01812304|Other|frontal teaching|one teacher demonstrates all 25 items listed in the OSATS checklist. Probands listen and watch.
16146041|NCT01812291|Behavioral|Step 1: Diabetes-Specific CBT (5 group sessions)|"Diabetes-Specific CBT (5 group sessions) focusing on diabetes-related problems and distress ('DIAMOS - Strengthening Diabetes Motivation').
~Includes:
~Diabetes problem analysis/ definition
~Diabetes problem solving intervention
~Cognitive restructuring of diabetes problems
~Activation of personal and social resources
~Goal definition and agreement"
16146042|NCT01812291|Behavioral|Step 2: Depression-Specific CBT (6 single sessions)|"Depression-Specific CBT (6 single sessions) focusing on depressive cognitions and affective problems (manualised).
~Includes:
~Functional explanatory model of depression
~Cognitive restructuring of negative thoughts
~Practice of alternative beneficial thoughts
~Specific cognitive interventions regarding self-criticism, guilt, low self-esteem, fear, and inactivity."
16146043|NCT01812291|Behavioral|Step 3: Referral to Psychotherapist and/or Psychiatrist|Non-responders to previous treatment steps will be referred to an psychotherapist and/or psychiatrist for intensified treatment. Treatments procedures will be monitored and interventions will be scored to enable the evaluation of treatment effects.
16146044|NCT01812291|Behavioral|Standard Diabetes Education|"Standard diabetes education and professional care.
~Includes:
~Health care and specific topics (e. g. blood pressure)
~Diabetes complications
~Healthy and unhealthy foods, cooking recommendations and recipes
~Foot care: exercises, care and control, injuries, and diabetic neuropathy
~Sports, activities and exercise
~Social aspects of living with diabetes"
16146045|NCT01812278|Behavioral|ACT|
16146046|NCT01812278|Behavioral|CBT|
16146047|NCT01812265|Drug|PF-06305591|single Dose
16146048|NCT01812265|Drug|PF-06305591|single Dose
16146049|NCT01812265|Drug|Placebo|Single Dose
16146050|NCT01812252|Drug|Azacitidine|Given IV or SC
16146051|NCT01812252|Drug|Decitabine|Given IV or SC
16146052|NCT01812252|Other|Quality-of-Life Assessment|Ancillary studies
16146053|NCT01812239|Drug|Vaginal Progesterone gel.|Daily administration of Vaginal Progesterone gel in pregnant women with twins between the 20th week of pregnancy and the 34th week of pregnancy.
16146054|NCT01812239|Procedure|fetal fibronectin swab.|Collection of quantatative fetal fibronectin swab one week after randomization into the trial for both arms. Randomziation occurs between 20 weeks - 24 weeks of gestation.
16146055|NCT01812239|Drug|Placebo gel|weekly vaginal administration of the placebo gel from randomization until 34 weeks of gestation.
16146056|NCT01812213|Drug|[18F]NAV4694|
16146057|NCT01812200|Drug|Dabigatran, Ticagrelor, ASA|
16146058|NCT01812200|Drug|Rivaroxaban, Ticagrelor, ASA|
16146059|NCT01812200|Drug|Phenprocoumon, Ticagrelor, ASA|
16146060|NCT01812187|Behavioral|SHIFT Cognitive Behavioral Therapy|Manualized, evidence-based, cognitive behavioral therapy for the treatment of substance abuse disorders
16146061|NCT01812174|Device|17mm aortic valve (On-X )|Heart aortic valve replacement surgery: 17mm Aortic
16146062|NCT01812174|Device|23mm mitral valve (On-X)|Heart mitral valve replacement surgery: 23mm Mitral
16146063|NCT01812161|Other|acupuncture protocol 1|Disposable, single-use, sterilized needles made of stainless steel, 0.25 x 30 mm and 0.30 x 40/50mm (Wuxi Jiajian Medical Instrument. 251226 Wuxi, China) will be inserted to a depth of 15-35 mm in some acupoints. After getting the needle sensation (de qi), some acupoints will receive electrical stimulation and the others will receive manual stimulation. All participants will receive treatment twice a week; each treatment session can be separated by an interval of 2-4 days, with a maximum of 32 treatment sessions during 16 weeks. Each treatment session lasts for 30 minutes.
16146064|NCT01812161|Other|Acupuncture protocol 2|Disposable, single-use, sterilized needles (0.20 x 20mm) made of stainless steel will be inserted to a depth of <5 mm at non-acupoints without evoking the needle sensation (Deqi). Electrodes will be attached to the needles and the stimulator will be turned on at an intensity of zero (no active current) in order to mimic EA in the acupuncture protocol 1 group. No manual stimulation of the needles will be performed.
16146065|NCT01812148|Procedure|Cytoreductive surgery and HIPEC|Cytoreductive surgery and hyperthermic intra-peritoneal chemotherapy (HIPEC) with Oxaliplatin as chemotherapeutic agent
16146066|NCT01812135|Biological|400 U EV71 vaccine with adjuvant|400 U EV71 vaccine contain 0.4 mg AL/0.5 ml aluminum hydroxide adjuvant
16146067|NCT01812122|Drug|Glimepiride|
16146068|NCT01812122|Drug|Vildagliptin|
16146069|NCT01812109|Device|Hutchison Technologies Inspectra StO2 SpotCheck Near-Infrared Spectroscopy|Device: Near-Infrared Spectroscopy Transscrotal NIRS is a series of 6 transcutaneous scrotal measurements, 3 on both left/right. Each measurement is completely non-invasive, painless and takes ~15 seconds each. Thus, no sedation or supplemental analgesia is needed for NIRS. The NIRS probe will be placed on the anterior, lateral and posterior scrotum on the left/right sides, immediately overlying and parallel to the long axis of the testis but on the skin to obtain the 6 total measurements. The unaffected testis will serve as the patient's own control. Study coordinators will be performing the ER transscrotal NIRS testing. For uniformity, all will be trained for testicular probe placement methods. NIRS will not delay the gray scale/color Doppler testicular US or surgery.
16146070|NCT01812096|Other|Subcutaneous bortezomib|
16146071|NCT01812096|Other|Intravenous bortezomib|
16146072|NCT01812070|Behavioral|ACT|
16146073|NCT01812070|Behavioral|CBT|
16146074|NCT01812057|Drug|Dexamethasone|Dexamethasone 8 mg IV (as a one time dose)
16146075|NCT01812057|Drug|Placebo|Sodium Chloride 0.9% -5 ml
16146076|NCT01812044|Drug|subtenons anesthetic - preservative-free bupivacaine 0.75%|
16146077|NCT01812044|Drug|topical anesthetic - 0.5 cc of lidocaine 3.5% ophthalmic gel|
16146078|NCT01812044|Drug|topical control - 0.5 cc of Hypromellose 0.3% gel|
16146079|NCT01812044|Drug|subtenons control - 0.5 cc of Normal Saline|
16146080|NCT01812031|Other|medical imaging|"After fasting for at least 6 hours, normal glucose blood level was checked and each patient received an intravenous injection of 18F-FDG (5MBq/kg). After a 60-minute uptake phase in a quiet environment, patients underwent the PET/CT examination.
~Whole-body PET/CT (Ungated session) The Ungated acquisition consisted in a whole-body, free-breathing CT followed by standard multistep PET, used as routine clinical practice in the department.
~Respiratory-gated PET/CT (CT-based session) The CT-based method consisted in an additional single-step, 10-minute List Mode respiratory gated PET acquisition followed by an end-expiration breath-hold CT added to the end of the clinical protocol, with continuous respiratory signal recording during these examinations."
16146081|NCT01812018|Drug|Endostar|Endostar administered at 7.5 mg/m2, intravenously (IV), on Day 1-14 every 21 days for up to 4-6 consecutive cycles
16146082|NCT01812018|Drug|Gemcitabine|Gemcitabine administered at 1000 mg/m2, intravenously (IV), on Day 1 and Day 8, every 21 days for up to 4-6 consecutive cycles
16146083|NCT01812018|Drug|Docetaxel|Docetaxel administered at 75 mg/m2, intravenously (IV), on Day 2, every 21 days for up to 4-6 consecutive cycles
16146084|NCT01812005|Drug|alisertib|Given PO
16146085|NCT01812005|Biological|rituximab|Given IV
16146086|NCT01812005|Other|laboratory biomarker analysis|Laboratory correlative studies will be performed
16146087|NCT01811992|Biological|Dose Escalation of Ad-hCMV-TK and Ad-hCMV-Flt3L|"Two adenoviral vectors will be used, each to deliver one of the therapeutic genes. Both vectors are human serotype 5, replication-defective, first generation adenoviral vectors deleted in E1a and E3 viral encoding regions. Each vector will constitutively express their respective therapeutic transgene (i.e. HSV1-TK or Flt3L) under the control of the human cytomegalovirus promoter (hCMV). Valacyclovir treatment will begin 1-3 days after vector administration at a dose of 2 grams given orally 3X per day for 14 days. A second course of valacyclovir will be given beginning Week 10.
~Radiation and chemotherapy will be administered as per standard of care."
16146088|NCT01811979|Dietary Supplement|Oral sucrose solution|Oral sucrose solution plus topical anesthetics
16146089|NCT01811979|Dietary Supplement|Steril water|steril water plus topical anesthetics
16146090|NCT01811966|Other|Volume|
16146091|NCT01811966|Other|Control|
16146092|NCT01811953|Drug|Empagliflozin|medium dose oral administration
16146093|NCT01811953|Drug|Metformin|oral administration
16146094|NCT01811953|Drug|Empagliflozin|low dose of Empagliflozin oral administration
16146095|NCT01811953|Drug|Empagliflozin/Metformin|low dose of Empagliflozin
16146096|NCT01811953|Drug|Metformin|oral administration
16146097|NCT01811953|Drug|Empagliflozin/Metformin|medium dose of Empagliflozin oral administration
16146098|NCT01811953|Drug|Empagliflozin|medium dose oral administration
16146099|NCT01811953|Drug|Metformin|oral administration
16146100|NCT01811953|Drug|Empagliflozin/Metformin|medium dose of Empagliflozin oral administration
16146101|NCT01811940|Drug|Adderall-ER|MAS-ER 60mg/day
16146102|NCT01811940|Drug|Topiramate|Topiramate 100 mg bid.
16146103|NCT01811940|Other|Placebo|Placebo
16146104|NCT01811927|Device|PRO-Kinetic Energy Stent|Bare-metal stent
16146105|NCT01811914|Other|intraoperative TTE|
16146106|NCT01811901|Other|Reduction of DTN|15-item list of suggested interventions aiming to reduce DNT sent to SITS-WATCH centers.
16146107|NCT01811888|Behavioral|Quantitative sensory testing (QST)|
16146108|NCT01811875|Biological|Optivate 500IU|
16146109|NCT01811862|Procedure|Acupuncture|Patients with multiple myeloma undergoing conditioning myeloablative chemotherapy followed by autologous hematopoietic stem cell transplantation. Patients will be randomized to acupuncture or sham acupuncture. Acupuncture treatment will be delivered once daily starting on Day -1 (Day -2 is the day chemotherapy starts). Acupuncture will continue for 5 days, or, when the patient's absolute neutrophil count drops below 200/microliter or platelet count drops below 20,000/microliter, whichever is sooner. Sham acupuncture will be delivered on the same schedule. Regardless of group assignment, every patient will receive the same usual prevention and treatment regimen for nausea, vomiting, anxiety, insomnia and fatigue that other patients who are undergoing conditioning chemotherapy in preparation for HSCT will receive in the Transplant Service.
16146110|NCT01811862|Procedure|Sham acupuncture|Patients with multiple myeloma undergoing conditioning myeloablative chemotherapy followed by autologous hematopoietic stem cell transplantation. Patients will be randomized to acupuncture or sham acupuncture. Acupuncture treatment will be delivered once daily starting on Day -1 (Day -2 is the day chemotherapy starts)Acupuncture will continue for 5 days, or, when the patient's absolute neutrophil count drops below 200/microliter or platelet count drops below 20,000/microliter, whichever is sooner. Sham acupuncture will be delivered on the same schedule. Regardless of group assignment, every patient will receive the same usual prevention and treatment regimen for nausea, vomiting, anxiety, insomnia and fatigue that other patients who are undergoing conditioning chemotherapy in preparation for HSCT will receive in the Transplant Service.
16146111|NCT01811849|Drug|Insulin LISPRO|
16146112|NCT01811849|Drug|Insulin LISPRO|
16146113|NCT01811849|Drug|Insulin LISPRO|
16146114|NCT01811836|Dietary Supplement|Zinc|Children will have an assessment of zinc homeostasis; each child is given 2 zinc stable isotopes, one by mouth and one intravenously, followed by a stool and urine collection (4 days.) Zinc isotopes are quantified in the feces and urine, values are used to calculate the primary outcome, net zinc balance. An assessment of EE quantitatively measured using the non-invasive site specific sugar absorption test, each child drinks 100 mL of a sugar solution and a urine collection follows. The quantities of non-metabolizable sugars are measured, and the ratio of two of the sugars, lactulose and mannitol, is a measure of environmental enteropathy. Children will receive a dietary supplement, corn starch, modified to reduce its absorption, for 5 weeks, which they will add to their phala. The RS is a standard food and has been used safely in millions of people for years. After taking this RS for 4 weeks both the zinc stable isotope test and the dual sugar absorption test will be repeated.
16146115|NCT01811823|Biological|Trivalent Inactivated Influenza Vaccine|"The study vaccine will be the seasonal 2013 un-adjuvanted TIV which is provided as a 0•5 milliliter suspension of split virus mixture of 15 micrograms each of circulating H1N1- like strain, H3N2- like strain and B - like strain.
~The WHO recommended vaccine formulation for Southern Hemisphere 2013 Influenza Season contains the following influenza strains:
~A/California/7/2009 (H1N1)pdm-like virus
~A/Victoria/361/2011 (H3N2)-like virus
~B/Wisconsin/1/2010-like virus. (Yamagata lineage)"
16146116|NCT01811810|Radiation|Radiation therapy (XRT)|
16146117|NCT01811810|Other|Androgen Deprivation Therapy (ADT)|
16146118|NCT01811810|Other|Chemotherapy|
16146119|NCT01811797|Device|Low Intensity Shockwave by Renova|
16146120|NCT01811797|Device|Sham treatment|Sham treatment that looks, sounds and feels like the real LISW treatment.
16146121|NCT01811784|Behavioral|Ask people not to drink raw sap|
16146122|NCT01811784|Behavioral|Ask people not to drink sap or drink sap from skirt protected trees|Behavioural
16146123|NCT01811784|Other|No Intervention|
16146124|NCT01811784|Other|No Intervention|
16146125|NCT01811771|Biological|Shanchol vaccine|Shanchol vaccine contains whole cell inactivated heat killed and formalin killed bacteria consisting of 600 ELISA Units (EU) of lipopolysaccharide (LPS). It consists of formalin-killed V. cholerae Inaba, El Tor biotype (strain Phil 6973). It also contains 300 EU LPS of heat-killed V. cholerae Ogawa classical biotype (Cairo 50); 300 EU LPS of formalin killed V. cholerae Ogawa classical biotype (Cairo 50); 300 EU LPS of heat-killed V. cholerae Inaba, classical biotype (Cairo 48); and 600 EU LPS of formalin killed V. cholerae O139 (4260B) (9). The vaccine has no detectable cholera toxin. Vaccine is packaged as liquid formulations in 1.5-ml doses. No buffer is needed for administered.This vaccine is licensed in India and WHO prequalified.
16146126|NCT01811758|Behavioral|Culturally Specific CBT|
16146127|NCT01811758|Behavioral|Standard CBT|
16146128|NCT01811745|Behavioral|Jaques-Dalcroze eurhythmics training|12 months of weekly, supervised, structured, progressive, 60-min music-based multitask exercise classes (i.e., Jaques-Dalcroze eurhythmics). The music-based multitask program includes all exercises used in a previous work.
16146129|NCT01811745|Behavioral|Multicomponent exercise training|12 months of weekly, i) supervised, structured, progressive, 60-min multicomponent exercise classes, supplemented by ii) 30-min home-based exercise sessions. Briefly, the multimodal exercise program is based on core components for successful fall prevention in older adults. It contains balance, gait, coordination and strength training, with balance as a core component.
16146130|NCT01811732|Drug|Delafloxacin|Delafloxacin
16146131|NCT01811732|Drug|Vancomycin|Vancomycin
16146132|NCT01811732|Drug|Aztreonam|Aztreonam
16146133|NCT01811732|Drug|Placebo|Placebo
16146134|NCT01811719|Behavioral|Enhanced NFP (NFP+)|Women in the experimental group received three possible interventions. First they received regular and periodic structured intimate partner violence (IPV) assessments from their nurse. Those who indicted any IPV - whether physical violence or emotional abuse or controlling behavior - were then given the Parker-McFarlane Brochure Intervention. Finally, all women were provided the Markman and Stanley Within My Reach curriculum according to their needs and interests.
16146135|NCT01811719|Behavioral|NFP as usual|The Nurse Family Partnership is a well-known and widely used nurse home visit program developed by David Olds. It has been rigorously tested and replicated and is now considered a best practice.
16146136|NCT01811706|Drug|Dalfampridine|Dalfampridine will be provided at an oral dose of 10mg every 12 hours, for 4 weeks period
16146137|NCT01811706|Drug|Placebo|Placebo will be administered orally every 12 hours, for a 4 week period.
16146138|NCT01811693|Drug|Glycerly Trinitrate|5mg/24hour (0.2mg/hour) transdermal
16146139|NCT01811693|Drug|Glycerly Trinitrate|10mg/24hour (0.4mg/hour) transdermal
16146140|NCT01811693|Drug|Glycerly Trinitrate|0.4 mg sublingual single metered spray
16146141|NCT01811680|Device|Variable Speed and Sensing Treadmill|open label study on variable speed and sending treadmill training for hemiplegic gait training.
16146142|NCT01811667|Drug|Sirolimus|
16146143|NCT01811654|Device|Intra-Articular Hyaluronic Acid-Euflexxa|IAHA was approved by the FDA in 1997 as a synovial fluid replacement device to help relieve the pain associated with knee osteoarthritis (OA) in patients who fail to respond adequately to conservative treatment and simple analgesics. In this study, IAHA, specifically Euflexxa, will be used off-label to determine whether patients afflicted with PFPS will experience similar analgesic effects as seen in those with OA.
16146144|NCT01811641|Other|season, dietary intake|
16146145|NCT01811628|Behavioral|Questionnaire|Questionnaire completion taking about 10-15 minutes.
16146146|NCT01811628|Behavioral|Interview|Audio-recorded interview that will last about 1 hour.
16146147|NCT01811615|Other|alcohol-free experimental mouth rinse|
16146148|NCT01811615|Other|alcohol-containing mouth rinsing|
16146149|NCT01811602|Other|Training|The participants randomized to the pelvic floor muscle training intervention will receive pelvic floor muscle training (0-12 weeks) delivered by a physiotherapist with clinical expertise and training in treating pelvic floor dysfunction. The intervention is 9 individual, one-on-one, 45-minute sessions; weekly for weeks 0-6 and bi-weekly for weeks 7-12 (first session will be 60 minutes). The sessions will provide pelvic floor muscle training based on the latest evidence, including biofeedback, to teach the correct technique for pelvic floor contractions, and participants will be asked to complete daily pelvic floor exercises at home.
16146150|NCT01811602|Other|Usual Care|The participants randomized to the educational pamphlet intervention (usual care control) will receive a 1-page sheet on pelvic floor muscle training, specifically Kegel exercises, which is equivalent to current standard care. Individuals randomized to this group will be placed on the clinic waiting list and be eligible for treatment following completion of the 12 week (end of study) measures.
16146151|NCT01811589|Device|Thomale-Guide|Ventricular catheter placement with the Thomale-Guide instrument
16146152|NCT01811589|Other|Free-hand|Ventricular catheter placement without a guidance (free-hand)
16146153|NCT01811576|Drug|TV-1106|
16146154|NCT01811576|Drug|Recombinant human growth hormone|Subcutaneous once daily
16146155|NCT01811563|Device|Zimmer|
16146156|NCT01811563|Device|Stryker|
16146157|NCT01811550|Other|Glycemic Control|
16146158|NCT01811537|Device|Artificial Chordae|
16146159|NCT01811511|Dietary Supplement|Chungkookjang|
16146160|NCT01811511|Dietary Supplement|Placebo|
16146161|NCT01811498|Drug|Bevacizumab|
16146162|NCT01811485|Drug|LMF237 50/250 mg|Corresponds to vildagliptin 50 mg twice daily and metformin 250 mg twice daily
16146163|NCT01811485|Drug|LMF237 50/500 mg|Corresponds to vildagliptin 50 mg twice daily and metformin 500 mg twice daily
16146164|NCT01811485|Drug|Placebo|Matching placebo of LMF237 (contained vildagliptin 50 mg as active ingredient) twice daily
16146165|NCT01811472|Drug|LCQ908|LCQ908 5 mg, 10 mg, 20 mg tablets
16146166|NCT01811472|Drug|placebo|Matching placebo of LCQ908 5 mg, 10 mg, 20 mg tablets.
16146167|NCT01811459|Drug|Quetiapine|PO
16146168|NCT01811459|Drug|Haloperidol|IV
16146169|NCT01811459|Drug|Placebo|PO or IV
16146170|NCT01811446|Device|Muscle Activation with Niveus and Intelect Devices|Subjects will receive muscle activation technology from the Niveus device on one leg and from the Intelect (commercially-available third-party) device on the other. The order of use and the leg applied to will be randomized.
16146216|NCT01811082|Drug|Coenzyme A|Coenzyme A 400mg per day.
16146171|NCT01811420|Procedure|Chemomechanical Caries Removal|Chemomechanical Caries Removal Using A Papain-Based Gel
16146172|NCT01811420|Procedure|Conventional method|Dental caries removal using rotatory instrument
16146173|NCT01811407|Behavioral|Precommitment announcement|
16146174|NCT01811407|Behavioral|Results announcement|
16146175|NCT01811407|Behavioral|Walking program|
16146176|NCT01811394|Radiation|protons|Treatment is performed using 16 x 4 GyE protons
16146177|NCT01811394|Radiation|carbon ions|Treatment is performed using 16 x 4 GyE carbon ions
16146178|NCT01811381|Drug|Curcumin|Subjects will take 800 mg of curcumin in 4 capsules BID per day prior to meals
16146179|NCT01811381|Behavioral|aerobic yoga|Each week, subjects will attend two one hour aerobic yoga classes under the supervision of certified yoga instructors and complete two 30 minute aerobic yoga practice sessions at home. If proficient, subjects will take a live-video conference remote class, HIPAA approved SecureVideo classes. Modification of consent has been approved.
16146180|NCT01811381|Behavioral|non aerobic yoga|"Subjects will take two non-aerobic (stretching) classes weekly as well as practice two 30 minutes yoga routines at home weekly.
~Each week, subjects will attend two one hour non-aerobic yoga classes under the supervision of certified yoga instructors and complete two 30 minute non-aerobic yoga practice sessions at home."
16146181|NCT01811381|Dietary Supplement|Placebo|Subjects will take 4 capsules x BID of placebo
16146182|NCT01811368|Biological|rituximab|Given IV
16146183|NCT01811368|Biological|ibritumomab tiuxetan|Given IV
16146184|NCT01811368|Biological|anti-thymocyte globulin|Given IV
16146185|NCT01811368|Radiation|total nodal irradiation|Undergo TLI
16146186|NCT01811368|Procedure|peripheral blood stem cell transplantation|Undergo allogeneic peripheral blood stem cell transplant
16146187|NCT01811368|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo allogeneic peripheral blood stem cell transplant
16146188|NCT01811368|Drug|cyclosporine|Given PO or IV
16146189|NCT01811368|Drug|mycophenolate mofetil|Given PO or IV
16146190|NCT01811355|Drug|Mexiletine|Sodium channel blocker
16146191|NCT01811355|Drug|Placebo|Placebo
16146192|NCT01811329|Dietary Supplement|Dairy fat|
16146193|NCT01811329|Dietary Supplement|Dairy fat + MFGM|BPC50, a dairy fraction rich in milk fat globule membrane proteins and phospholipids manufactured by Fonterra, will make up 50% of the shake's total fat.
16146194|NCT01811329|Dietary Supplement|Palm fat|
16146195|NCT01811329|Dietary Supplement|Palm fat + MFGM|BPC50, a dairy fraction rich in milk fat globule membrane proteins and phospholipids manufactured by Fonterra, will make up 50% of the shake's total fat.
16146196|NCT01811316|Other|Probiotics|
16146197|NCT01811303|Other|D-fagomine|Measure the changes produced on the postprandial Glycaemic response to 50 g of sucrose in 200 ml water if added 40 mg D-fagomine
16146198|NCT01811277|Drug|SOX sequential S-1|"4-6 cycles SOX followed by S-1 monotherapy until disease progression
~S-1: 40~60mg bid，po, d1~14 （S-1：BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid） oxaliplatin：130mg/m2，iv drip for 2h，d1"
16146199|NCT01811264|Behavioral|Patient-Participation Aid|The PPA consists of a folder that addresses the three behaviors we hope to influence: agenda setting, asking questions, and making preferences known. The information inside contains sample questions for each section, with room for the patient to write her own questions. Each section models behavior by giving context for the items and specific example questions. It also addresses barriers to understanding by indicating that it is acceptable to ask questions when something is not clear or terms are unfamiliar.
16146200|NCT01811251|Drug|Pregabaline (150mg), Dexamethasone (20mg/5ml; 0.2mg/kg)|
16146201|NCT01811238|Drug|Oxycodone/naloxone|Targin 5mg, 10mg, 20mg up to 40mg b.i.d
16146202|NCT01811225|Drug|Low-dose Progesterone|"The low progesterone dose is seven days of placebo Tri-sprintec + placebo generic Prometrium twice a day (7AM and 7PM)."
16146203|NCT01811225|Drug|High-dose Progesterone|"The high progesterone dose is seven days of placebo Tri-Sprintec + 200mg of generic Prometrium twice a day (7AM and 7PM)."
16146204|NCT01811212|Drug|Cabozantinib S-malate|Given PO
16146205|NCT01811212|Other|Laboratory Biomarker Analysis|Correlative studies
16146206|NCT01811186|Drug|Oxycodone/naloxone|Oxycodone/naloxone titration
16146207|NCT01811173|Other|Nurse-physician comprehensive care|"Components of the intervention include:
~Complete assessment of the patient's and family's needs conducted by the nurse.
~Comprehensive treatment program developed by the nurse and in consultation with the primary care physician.
~Multimorbid care plan integrating all care aspects.
~Action Plan for patients, supporting self management
~Proactive monitoring according to the plan."
16146208|NCT01811160|Drug|Melatonin|A capsule of melatonin was administered nightly (20:00hrs).
16146209|NCT01811160|Drug|Placebo|Placebo capsules were administered at 20:00hrs for eight weeks
16146210|NCT01811147|Drug|Selective Serotonin Reuptake Inhibitor (SSRI)|Subjects with depression will be treated with a Selective Serotonin Reuptake Inhibitor (SSRI) or a Serotonin-norepinephrine reuptake inhibitor (SNRI) for 24 months.
16146211|NCT01811134|Device|PIPELINE flow diverter stent|endovascular procedure using the medical device PIPELINE
16146212|NCT01811134|Device|Coils, with or without expendable stent|endovascular embolization procedure using microspires, with the possibility of using a balloon temporary and / or implantation of a stent complementary intracranial before implementation of microspires
16146213|NCT01811121|Drug|5-aminolévulinique acid (5-ALA)|oral administration of 20mg/kg of 5-ALA 3-5 hours before the surgical incision
16146214|NCT01811121|Drug|Placebo|Oral administration of 1g of ascorbic acid LAROSCORBINE in 50ml of water 3 hours before surgery
16146215|NCT01811095|Other|Training|"Training with the da Vinci® Skills Simulator to complete a proficiency-based curriculum in 6 simulator exercises relevant to robotic suturing over a 5-week period. We will ask participants in the training group to aim to complete the exercises Camera targeting 1, Camera targeting 2, Suture sponge 1, Suture sponge 2,and Suture sponge 3 to the target score (overall score green checkmark and all component scores to the level of yellow triangle or green checkmark, equivalent to a completed score) on two non-consecutive attempts. For the Suturing skills (SymbionixTM): Horizontal suturing defect task, the scoring is different. For this task, we have elected to ask participants to aim to complete the task ten times,rather than to achieve a certain target score."
16146217|NCT01811082|Drug|Pantethine|Pantethine 600mg per day.
16146218|NCT01811069|Procedure|Head up|30˚ reverse trendelenburg body position
16146219|NCT01811056|Drug|Mifepristone|Mifepristone use outside of the center
16146220|NCT01811043|Behavioral|Guided Meditation|
16146221|NCT01811043|Behavioral|Music|
16146222|NCT01811043|Behavioral|Supportive Dialogue|
16146223|NCT01811030|Device|755nm Alexandrite Laser|755nm Alexandrite Laser
16146224|NCT01811017|Device|755nm Alexandrite Laser|755nm Alexandrite Laser
16146225|NCT01811004|Device|miraDry|miraDry
16146226|NCT01811004|Device|Nd:YAG Laser|Nd:YAG 1440 nm Laser
16146227|NCT01811004|Device|Botox®|Botox®
16146228|NCT01810991|Device|Nd:YAG Laser|Nd:YAG 1440nm Laser
16146229|NCT01810978|Dietary Supplement|Bifidobacterium lactis plus inulin|5 billion unit Bifidobacterium lactis plus 900 mg inulin per day will be given
16146230|NCT01810978|Dietary Supplement|Maltodextrin|same amount of maltodextrin per day will be given as placebo
16146231|NCT01810965|Procedure|First evaluation phase : no intervention / Second evaluation phase: bloodletting of 7 ml/kg (with a maximum of 500ml)|
16146232|NCT01810952|Drug|Glargine insulin|In both protocols glargine dose was increased by 10% if the FSG value was 141-200 mg/dL and by 20% if the FSG value was more than 200 mg/dL, and decreased by 10% if the FSG was 70-89 mg/dL and by 20% if the FSG was less than 70 mg/dL.
16146233|NCT01810952|Drug|Lispro insulin|In both protocols lispro insulin was given to cover meals. Additional lispro insulin was Lispro insulin was administered before meals to cover the prednisone or glucocorticoid equivalent in the Glargine/Lispro Insulin Arm.
16146234|NCT01810952|Drug|NPH Insulin|NPH insulin was given once or twice a day to cover the prednisone or glucocorticoid equivalent in the Glargine/Lispro/NPH Insulin Arm
16146235|NCT01810939|Drug|Patiromer|
16146236|NCT01810939|Drug|Placebo|
16146237|NCT01810926|Biological|polyclonal antibody|iv at a dose of 5 mg/kg within 8 hours on day -4,-3,-2 (total dose 15 mg/kg)
16146238|NCT01810926|Drug|Rituximab|single infusion of200 mg/m2 on day -1
16146239|NCT01810926|Drug|Treosulfan|iv at a dose of 14 g/m² within 120 minutes on day -7, - 6, -5 (total dose of 42 g/m²)
16146240|NCT01810926|Drug|Fludarabine|iv at a dose of 30 mg/ m² within 30 minutes on day -7, -6, -5,-4,-3 after treosulfan
16146241|NCT01810926|Drug|Thiotepa|iv at a dose of 8 mg/kg on day - 3 divided into 2 infusions at 12 hrs intervals
16146242|NCT01810926|Drug|Cyclosporine A|iv at a dose of 3 mg/kg/day starting from day -1 and a dose adjustment will be done to obtain plasma levels of 150-250 ng/mL
16146243|NCT01810926|Drug|Methotrexate|iv at a dose of 15 mg/m2 on day +1, at a dose of 10 mg/m2 on day + 3 and + 6
16146244|NCT01810926|Drug|Methotrexate|iv at a dose of 15 mg/m2 on day +1, at a dose of 10 mg/m2 on day + 3 and + 6 and at a dose of 10 mg/m2 on day +11
16146252|NCT01810900|Device|Protescal|
16146253|NCT01810887|Drug|Darunavir|Darunavir ethanolate will be administered as single oral dosing of two tablets of 300 milligram (mg) on Day 3.
16146254|NCT01810887|Drug|Ritonavir|Ritonavir capsule will be administered orally twice daily at a dose of 100 mg for 5 days.
16146255|NCT01810874|Procedure|Transperitoneal laparoscopic aortic lymphadenectomy|Aortic/para-aortic lymph nodes dissection and retrieval by transperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy.
16146256|NCT01810874|Procedure|Extraperitoneal laparoscopic aortic lymphadenectomy|Aortic/para-aortic lymph nodes dissection and retrieval by extraperitoneal laparoscopy; the intervention may be completed by robotic-assisted or traditional laparoscopy.
16146257|NCT01810861|Other|There is no intervention in this study|This is a non-interventional study.
16146258|NCT01810848|Device|Hylan G-F 20|"Synvisc is an elastoviscous high molecular weight fluid which is injected into the knee joint (intra-articular) for relief of pain from osteoarthritis in patients who have failed to respond adequately to conservative non-pharmacologic therapy and simple analgesics."
16146259|NCT01810848|Other|Control|Control is puncture of the skin at the site of the knee.
16146260|NCT01810809|Procedure|articular lavage with saline injection|Patients will receive articular lavage with saline injection
16146261|NCT01810809|Drug|1 ampoule of Hylan GF-20|Patients will receive viscosupplementation with 2ml (1 ampoule) of Hylan GF-20
16146262|NCT01810809|Drug|2 ampoules of Hylan GF-20|Patients will receive viscosupplementation with 4ml (2 ampoules) of Hylan GF-20
16146263|NCT01810809|Drug|3 ampoules of Hylan GF-20|Patients will receive viscosupplementation with 6ml (3 ampoules) of Hylan GF-20
16146264|NCT01810796|Drug|Ranolazine|Ranolazine versus placebo
16146265|NCT01810783|Drug|Brexpiprazole|1 to 4 mg/day, once daily, tablets, orally. The patients received 2 mg/day brexpiprazole on Day 1. If a patient could not tolerate the 2 mg dose on Day 1, the dose was decreased to 1 mg/day at Day 2. The patients received 1 or 2 mg/day from Days 2 to 7, 1, 2, or 3 mg/day from Days 8 to 14, and 1, 2, 3, or 4 mg/day from Day 15 to completion of the Treatment Period (up-titration).
16146266|NCT01810770|Drug|Radium-223 dichloride (Xofigo, BAY88-8223)|Radium-223 dichloride, 55 kBq/kg body weight, will be administered as a slow bolus IV injection at 4 week intervals for up to 6 doses.
16146267|NCT01810757|Radiation|Standard planning radiotherapy|36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, using one plan per patient.
16146268|NCT01810757|Radiation|Adaptive planning radiotherapy|36 Gray dose given in 6 fractions of 6 Grays over 6 weeks, selecting the best fit from three plans per patient.
16146269|NCT01810744|Other|capillaroscopy|
16146270|NCT01810744|Other|blood pressure measurement|
16146271|NCT01810731|Biological|Quadrivalent Inactivated Influenza Vaccine (QIV)|
16146272|NCT01810731|Biological|Inactivated Polio Vaccine|
16146273|NCT01810731|Biological|Double Dose QIV|
16146452|NCT01809353|Other|Placebo|Single matching intravenous dose
16146274|NCT01810718|Drug|nilotinib|Maximum tolerated dosage (MTD) will be defined in Phase I. First 3 patients (pts) will receive Nilotinib 200mg daily dose. If no dose limiting toxicities after at least 1month the next 3 pts will be treated with 300mg. If are>=2 dose limiting toxicities the Phase I will end and MTD will be defined as the next lower dosage. If they will observe 1dose limiting toxicities, they will treat other 3 pts (same dosage); if there isn't dose limiting toxicity, they will increase the dosage in the next cohort; but if they will observe another dose limiting toxicity (tot limiting toxicities 2/6 pts), the study will continue using the previous dose. MTD will be considered the maximum dosage used to treat 6 pts achieving at most 1 dose limiting toxicities, or the previous dosage if with this dosage they we will achieve 2 dose limiting toxicities. Doses will not be escalated beyond >600 or <200mg/die The MTD will be used for phase II
16146275|NCT01810705|Drug|GRASPA|Patients receiving Intervention (experimental group) will be treated with one injection of graspa per cycle of treatment, each cycle during 28 days, for a duration up to 24 cycles maximum
16146276|NCT01810692|Device|Group1:Spiriva® Respimat®|COPD patients using Respimat®
16146277|NCT01810692|Device|Group2:Hirobriz®/Oslif®/Onbrez® Breezhaler®|COPD patients using Breezhaler®®
16146278|NCT01810679|Device|Perceval S Aortic Heart Valve|Perceval S Sutureless Aortic Heart Valve
16146279|NCT01810666|Biological|Recombinant Factor VIII (Kogenate FS, BAY14-2222)|Participants received Recombinant Factor VIII (Rec. factor VIII) on-demand treatment for 12 weeks followed by a 12 weeks prophylaxis treatment phase. The dose and mode of prophylaxis treatment was 25 IU/Kg, 3 times/per week. The dose in on-demand treatment was decided by physician according to the package insert or the current standard of care.
16146280|NCT01810653|Drug|Macrogol (Transipeg, BAY81-8430)|Up to 4 sachets per day based on individual titration
16146281|NCT01810653|Drug|Macrogol (Forlax)|Up to 4 sachets per day based on individual titration
16146282|NCT01810640|Procedure|Percutaneous Liver Biopsy|Using a 16 gauge Jamshidi biopsy needle, without image guidance, 3 passes will be completed to obtain core liver biopsies. Biopsies will be placed on wet saline and processed via frozen sample in OCT compound in 5 micron slices and stained with hematoxylin and eosin for microscopic evaluation. Slides will then be digitalized and shared on Donor.net.
16146283|NCT01810627|Radiation|MVCT|Patients will receive an additional MVCT scan at their one month follow up visit.
16146284|NCT01810614|Other|ADPKD Diet|Diet specifically designed for people with ADPKD
16146285|NCT01810601|Drug|GnRh, HMG, HCG, Progesterone|GnRh analogue (0.05 mg/day), HMG (150-300 iu/day), HCG (5000 iu/day), Progesterone (100 mg/day)
16146286|NCT01810588|Device|CliniMACS® CD34 Reagent System|The stem cells from the haplo-identical donor will be purified by a procedure called CD34 selection before they are given to the subject. A special device called the CliniMACS® CD34 Reagent System, which is not FDA approved, will be used for this purpose. The manufacturer of the device, Miltenyi Biotec, is providing the researchers access to the device for use in this research study. Because the stem cells from the haplo-identical donor are treated using the CliniMACS CD34 selection device, they cells are considered investigational.
16146287|NCT01810588|Drug|Fludarabine|Administer 30 mg/m2 /day intravenously x 5 days (Day -7 to Day -3) of a total dose of 150 mg/m2. Fludarabine will be dosed according to actual body weight.
16146288|NCT01810588|Drug|Melphalan|Administer 70mg/m2/day intravenously x 2 days. Melphalan will be dosed according to actual body weight. Cryotherapy with ice chips will be administered to prevent mucositis
16146289|NCT01810588|Drug|anti-thymocyte globulin (rabbit)|Administer 1.5 mg/kg/day intravenously x 3 days, total 4.5 mg/kg. ATG will be dosed according to actual body weight. The first dose will be infused over at least six hours, and subsequent doses over at least 4 hours. Pre-medications include acetaminophen 650 mg by mouth, diphenhydramine 25-50 mg by mouth or intravenously, and methylprednisolone 2 mg/kg (1 mg/ kg at the initiation and 1 mg/kg half-way through anti-thymocyte globulin administration).
16146290|NCT01810588|Drug|Rituximab|Administer one dose of 375 mg/m2 prior to or upon admission for all patients not previously exposed to rituximab or who have not received rituximab in the six months prior to transplant.
16146291|NCT01810588|Radiation|Total Body Irradiation|Patients at high risk of CNS relapse (e.g. ALL or Burkitt's lymphoma) or patients at high risk for graft rejection (i.e., donor-specific HLA antibodies, patients with severe aplastic anemia, or hemoglobinopathies) may receive 2 doses of TBI as part of the conditioning.
16146292|NCT01810588|Drug|Mycophenolate Mofetil|Will be started on Day -2 and given at a dose of 1000 mg every 8 hours until Day 28. Mycophenolae Mofetil can be given orally or intravenously. Infection, toxicity, very low patient weight (<50 kilograms) may prompt earlier discontinuation or adjustment of doses.
16146293|NCT01810588|Drug|Tacrolimus|Administered 0.03/mg/kg/day intravenous continious infusion (CI) over 24 hours from 4pm Day -2 until engraftment or when subject is able to take orally, then tacrolimus approximately 0.09 mg/kg orally in 2 divided doses. Tacrolimus should be given at full dose to maintain levels of 5-15 ng/mL through Day 180, tapered by 20% every week thereafter. Infection, toxicity or other clinical circumstances may prompt earlier discontinuation or adjustment of doses. In the presence of Graft versus Host Disease, a clinical decision by the attending physician will determine if tacrolimus can be tapered or should be continued. Oral tacrolimus can be used when intravenous access for CI tacrolimus is unavailable.
16146294|NCT01810575|Drug|WC3036-11F/Alprostadil in Vehicle 2.5%|330 mcg alprostadil in 2.5% vehicle
16146295|NCT01810575|Drug|WC3036-12F/Alprostadil in Vehicle 0.5%|330 mcg alprostadil in 0.5% vehicle
16146296|NCT01810575|Drug|WC3036-13P/Vehicle Only 0.5%|100 mg cream vehicle 0.5%.
16146297|NCT01810562|Other|Specific treatment in addition to standard stroke care|"Stimulation of both the affected side and not affected side. Treatment twice per day for three months. Unperturbed side always stimulated first.
~Isstimulering achieved by an ice cube melted on each of the affected ektremitetene evenly distributed.
~Brushing on thin clothing or directly on the skin, 10 times rapidly for each location. On the back of m. deltoideus from right to left side of the body, laterally along the humerus, frontally, along the radius / ulna laterally, frontal and dorsal palm, along the femur first laterally and frontally, along the tibia / fibula laterally, frontally and the footplate dorsal side.
~Scrolling with spiked ball over the same area as brushing for two minutes evenly.
~Firm pressure for two minutes evenly in the same area."
16146298|NCT01810549|Drug|Anakinra|Each subject will receive one single subcutaneous injection of 100mg Anakinra during the study, a total of one injection.
16146508|NCT01809028|Procedure|EUS FNA with 2 passes|biopsy with 2 passes
16146299|NCT01810549|Drug|Placebo|Every subject will receive one single subcutaneous injection of Placebo during the study, a total of one injection.
16146300|NCT01810536|Device|Hi-flow nasal cannula|Different ways of providing supplemental oxygen will be compared: hi-flow nasal cannulas versus Venturi masks
16146301|NCT01810536|Device|Venturi mask|
16146302|NCT01810523|Behavioral|Narrative|Narrative form as described above.
16146303|NCT01810523|Behavioral|Control|Blank piece of paper
16146304|NCT01810510|Procedure|PAV Ventilation|PAV is a mode of ventilation in which the only set parameter is the proportion of work/effort that is provided regardless of the ventilatory pattern the patient chooses- the patient has full control over pressure, volume, flow and time of inspiration as well as respiratory rate. In this mode, the ventilator measures patient respiratory mechanics every 10-15 breaths and delivers a level of pressure proportional to patient effort, thereby maintaining a set proportion of patient effort regardless of the patient's ventilatory pattern. The patients will be on this mode of ventilation for 60 minutes.
16146305|NCT01810510|Procedure|NAVA Ventilation|With NAVA, delivery from the ventilator is triggered, controlled and cycled by the diaphragmatic EMG signal (Edi), which is measured by a specially designed nasogastric or orogastric catheter (NGT or OGT) containing EMG electrodes that cross the diaphragm. In this mode, the ventilator measures the Edi with each breath and instantaneously delivers a level of pressure proportional to Edi magnitude, thereby providing a set proportion of effort on a breath-to-breath basis. The patients will be on this mode of ventilation for 60 minutes.
16146306|NCT01810497|Procedure|Use of ear bandage|Elastic bandage to be used on the postoperative period of otoplasty, starting immediately after the procedure. To be used 24hours/day for the specified period.
16146307|NCT01810484|Device|Ultherapy® treatment only|Focused ultrasound energy delivered below the surface of the skin
16146308|NCT01810484|Device|Ultherapy® treatment and CO2 laser treatment|"Ultherapy® treatment: Focused ultrasound energy delivered below the surface of the skin;
~CO2 Laser: Fractionated energy delivered to the surface of the skin for ablative and thermal injury to the skin layers for resurfacing the skin."
16146309|NCT01810484|Device|CO2 Laser treatment only|CO2 Laser: Fractionated energy delivered to the surface of the skin for ablative and thermal injury to the skin layers for resurfacing the skin.
16146310|NCT01810471|Device|Applying ankle support device (white non-elastic tape, kinesiotape (TM), soft brace (Malleotrain TM)|
16146311|NCT01810458|Device|Abdominal ultrasound|Abdominal ultrasound will be done at the liver biopsy visits. The purpose of the ultrasound is to evaluate for the presence of liver fibrosis and identify the biopsy site.
16146312|NCT01810458|Procedure|History and physical|Every study participant will be asked about their medical history and will have a physical exam done at the screening, year 1, year 2, and year 3 visits.
16146313|NCT01810458|Procedure|Intravenous catheter|Every study participant will have and intravenous catheter (IV) placed at every study visit. The IV will be used for the collection of blood at the screening, year 2, year 2, and year 3 visits. It will also be used for the administration of medication at the first liver biopsy, as well as the year 3 visit if the biopsy is repeated.
16146314|NCT01810458|Procedure|Blood draw|At the screening, year 1, year 2, and year 3 visits, every participant will have blood collected from the IV that is placed in one of their veins.
16146315|NCT01810458|Other|Liver questionnaire|At the screening and year 3 visits, every subject will complete a questionnaire which involves questions regarding liver health.
16146316|NCT01810458|Procedure|Liver Biopsy|Every participating subject who passes the screening visit, will have a liver biopsy done with the use of lidocaine (a numbing medicine) injected into skin where the biopsy will be collected. At the time of the biopsy, either lorazepam (a medicine used to treat anxiety and cause relaxation) or midazolam (a medicine used to cause sleepiness and amnesia) and fentanyl (a medicine used to relieve pain) will be used. Once the relaxation medication and numbing medicine have been given, a sample of liver tissue will be collected using a needle biopsy device.
16146317|NCT01810458|Drug|Midazolam|Every participating subject who passes the screening visit, will have a liver biopsy done with the use of lidocaine injected into skin where the biopsy will be collected. At the time of the biopsy, either lorazepam (a medicine used to treat anxiety and cause relaxation) or midazolam (a medicine used to cause sleepiness and amnesia) and fentanyl (a medicine used to relieve pain) will be used. After the biopsy is done, participants who continue to have pain may receive either oxycodone/acetaminophen or acetaminophen (medicines used to relieve pain). Any participant who experiences nausea may receive ondansetron (a medicine used to relieve nausea).
16146318|NCT01810458|Drug|Fentanyl|Every participating subject who passes the screening visit, will have a liver biopsy done with the use of lidocaine injected into skin where the biopsy will be collected. At the time of the biopsy, either lorazepam (a medicine used to treat anxiety and cause relaxation) or midazolam (a medicine used to cause sleepiness and amnesia) and fentanyl (a medicine used to relieve pain) will be used. After the biopsy is done, participants who continue to have pain may receive either oxycodone/acetaminophen or acetaminophen (medicines used to relieve pain). Any participant who experiences nausea may receive ondansetron (a medicine used to relieve nausea).
16146319|NCT01810458|Drug|Lidocaine|Every participating subject who passes the screening visit, will have a liver biopsy done with the use of lidocaine injected into skin where the biopsy will be collected. At the time of the biopsy, either lorazepam (a medicine used to treat anxiety and cause relaxation) or midazolam (a medicine used to cause sleepiness and amnesia) and fentanyl (a medicine used to relieve pain) will be used. After the biopsy is done, participants who continue to have pain may receive either oxycodone/acetaminophen or acetaminophen (medicines used to relieve pain). Any participant who experiences nausea may receive ondansetron (a medicine used to relieve nausea).
16146320|NCT01810458|Drug|Acetaminophen|Every participating subject who passes the screening visit, will have a liver biopsy done with the use of lidocaine injected into skin where the biopsy will be collected. At the time of the biopsy, either lorazepam (a medicine used to treat anxiety and cause relaxation) or midazolam (a medicine used to cause sleepiness and amnesia) and fentanyl (a medicine used to relieve pain) will be used. After the biopsy is done, participants who continue to have pain may receive either oxycodone/acetaminophen or acetaminophen (medicines used to relieve pain). Any participant who experiences nausea may receive ondansetron (a medicine used to relieve nausea).
16146361|NCT01810120|Biological|TCR alfa beta T cell depletion|total nucleated cells from the leukapheresis product will undergo TCR alfa beta negative selection and the product of the depletion will be infused to the patient
16146321|NCT01810458|Drug|Lorazepam|Every participating subject who passes the screening visit, will have a liver biopsy done with the use of lidocaine injected into skin where the biopsy will be collected. At the time of the biopsy, either lorazepam (a medicine used to treat anxiety and cause relaxation) or midazolam (a medicine used to cause sleepiness and amnesia) and fentanyl (a medicine used to relieve pain) will be used. After the biopsy is done, participants who continue to have pain may receive either oxycodone/acetaminophen or acetaminophen (medicines used to relieve pain). Any participant who experiences nausea may receive ondansetron (a medicine used to relieve nausea).
16146322|NCT01810458|Drug|Oxycodone/Acetaminophen|Every participating subject who passes the screening visit, will have a liver biopsy done with the use of lidocaine injected into skin where the biopsy will be collected. At the time of the biopsy, either lorazepam (a medicine used to treat anxiety and cause relaxation) or midazolam (a medicine used to cause sleepiness and amnesia) and fentanyl (a medicine used to relieve pain) will be used. After the biopsy is done, participants who continue to have pain may receive either oxycodone/acetaminophen or acetaminophen (medicines used to relieve pain). Any participant who experiences nausea may receive ondansetron (a medicine used to relieve nausea).
16146323|NCT01810458|Drug|Ondansetron|Every participating subject who passes the screening visit, will have a liver biopsy done with the use of lidocaine injected into skin where the biopsy will be collected. At the time of the biopsy, either lorazepam (a medicine used to treat anxiety and cause relaxation) or midazolam (a medicine used to cause sleepiness and amnesia) and fentanyl (a medicine used to relieve pain) will be used. After the biopsy is done, participants who continue to have pain may receive either oxycodone/acetaminophen or acetaminophen (medicines used to relieve pain). Any participant who experiences nausea may receive ondansetron (a medicine used to relieve nausea).
16146324|NCT01810432|Drug|Evacetrapib|Administered orally
16146325|NCT01810432|Other|High-fat Meal|Administered orally, at breakfast.
16146326|NCT01810419|Device|Vscan Ultrasound (GE Healthcare, USA)|Vscan Ultrasound used to determine spleen size and the other qualities described in the arm description.
16146327|NCT01810419|Device|Conventional Ultrasound|Conventional Ultrasound used to determine spleen size and the other qualities described in the arm description.
16146328|NCT01810406|Procedure|CSE with 10 ml EVE|Combined Spinal-Epidural (CSE) with 10 ml Epidural Volume Extension (EVE)
16146329|NCT01810406|Procedure|CSE without EVE|Combined Spinal-Epidural (CSE) without Epidural Volume Extension (EVE)
16146330|NCT01810393|Drug|Trastuzumab|Trastuzumab will be administered at a dose of 6 milligrams per kilogram (mg/kg) IV or 600 milligrams per 5 milliliter (mg/5mL) SC in 21-day cycles as per schedule described in respective arm.
16146331|NCT01810380|Drug|Placebo|Once daily as tablets and capsules, orally
16146332|NCT01810380|Drug|Brexpiprazole|2-4 mg/day, once daily, tablets, orally
16146333|NCT01810380|Drug|Quetiapine extended release|400-800 mg/day, once daily, encapsulated tablets, orally
16146334|NCT01810367|Drug|ABX Combined With Cisplatin|
16146335|NCT01810367|Drug|Gemcitabine Combined With Cisplatin|
16146336|NCT01810354|Drug|Cefazolin|
16146337|NCT01810328|Other|Traumatized population|In the traumatized population (severe blunt traumatic injury), blood samples will be collected at admission, days 1, 4, 7, 14, 21 and 28, or until discharge from the ICU or death. A total of 5 mLs of blood will be collected at admission and day 1, 4 mLs of blood will be collected at each remaining time point.
16146338|NCT01810328|Other|Healthy Volunteers|The healthy volunteer participants will donate a one-time 5 mL blood sample which will undergo rapid leukocyte genomic screening. These controls will allow the investigators to determine if the values obtained are accurate, reliable, and repeatable.
16146339|NCT01810315|Drug|TFV 1% gel|
16146340|NCT01810315|Drug|Estradiol vaginal cream|
16146341|NCT01810302|Drug|Nicardipine hydrochloride|Nicardipine hydrochloride 4mg by intrathecal administration twice a day until post-hemorrhage day 10.
16146342|NCT01810302|Drug|Preservative-free normal saline|Preservative-free normal saline 1.6 mL by intrathecal administration twice a day until post-hemorrhage day 10.
16146343|NCT01810289|Behavioral|START|"INTERVENTION: START is clinic-level (not individual-patient) intervention to catalyze the process of ART initiation among HIV-infected adults who meet CD4-based criteria for combination ART (e.g., adults with a CD4 T cell level < 350/ul). The three START components are: (1) real-time point-of-care CD4 testing using the Alere PIMA platform to ascertain treatment eligibility in real time at first presentation to care, (2)targeted knowledge transfer(i.e., dissemination) of recent scientific evidence regarding effects rapid ART initiation on survival to front line health care workers; and 3)feedback and reporting to clinic and providers. There three components represent empirically validated steps in the PRECEED implementation model.
~This intervention will be implemented at all Makerere Joint AIDS Program (MJAP) clinics in Kampala and Mbarara districts in a step-wedge design."
16146344|NCT01810276|Other|Saline|400 mL of Saline will be given intravenously over 2 hours once
16146345|NCT01810276|Other|Platelets|2 apheresis units of platelets (approximately 200 ml) will be given intravenously over 2 hours.
16146346|NCT01810263|Dietary Supplement|high protein supplement|Dietary Supplement: high protein supplement
16146347|NCT01810250|Device|Endurant Stent Graft|
16146348|NCT01810237|Drug|Dabigatran.|Dabigatran will be used instead of LMWH for anticoagulation bridging.
16146349|NCT01810224|Procedure|Surgical revascularization|The final intervention (surgical revascularization) will be the same for both arms.
16146350|NCT01810211|Other|Horizontal Adduction Stretch and Pendulums|
16146351|NCT01810211|Other|Modified Sleeper Stretch and Pendulum|
16146352|NCT01810198|Procedure|Cardiac CT|Perform a non-invasive Cardiac CT Angiogram
16146353|NCT01810198|Procedure|Invasive Coronary Angiography|Patient undergoes Invasive Coronary Angiography
16146354|NCT01810185|Drug|Low dose naltrexone|4.5 mg daily for 12 weeeks
16146355|NCT01810185|Drug|Placebo|
16146356|NCT01810172|Device|Digital pleural drainage system|Reusable device with disposable collection system for digital monitoring of air leak.
16146357|NCT01810172|Device|Dry suction pleura drainage device|Disposable dry suction operating system. Collects pleural fluid and monitors for air leak.
16146358|NCT01810159|Other|Integrated collaborative care|
16146359|NCT01810159|Other|Education and Resources|
16146360|NCT01810146|Other|Digestive functions investigations|
16146362|NCT01810107|Procedure|Children Examined with the OCT Probe|The child undergoing therapy will have the Optical Coherence Tomography (OCT) probe to examine the vocal fold.
16146363|NCT01810094|Device|Fracture Fixation|Thoracolumbar Fracture Fixation
16146364|NCT01810068|Procedure|Holmium laser enucleation of the prostate|Laser assisted enucleation of the prostatic adenoma
16146365|NCT01810068|Procedure|Monopolar transurethral resection of the prostate|using the monopolar electrocautery to resect the prostate adenoma
16146366|NCT01810068|Procedure|Bipolar transurethral resection of the prostate|using the bipolar electrocautery to resect the prostate adenoma
16146367|NCT01810068|Procedure|Diagnostic cystoscopy|Cysto-urethroscopy
16146368|NCT01810042|Drug|ranibizumab|0.5mg of ranibizumab is injected into the vitreous cavity through pars plana.
16146369|NCT01810029|Behavioral|Cardiac Rehabilitation plus Transcendental Meditation|The stress reduction intervention, Transcendental Meditation program is added on to the standard cardiac rehabilitation programs for patients with documented coronary artery disease
16146370|NCT01810016|Biological|Ipilimumab|Ipilimumab was administered IV over 90 minutes at a dose of 3 mg/kg directly preceding the NY-ESO-1 injection every 3 weeks for 4 doses.
16146371|NCT01810016|Biological|NY-ESO-1 Protein Vaccine|NY-ESO-1 recombinant protein (250 µg) was mixed with Poly-ICLC (1 mg) and Montanide ISA-51 VG (1 mL) and administered SC directly following the ipilimumab infusion every 3 weeks for 4 doses.
16146372|NCT01810016|Biological|NY-ESO-1 OLP4 Vaccine with Poly-ICLC and Montanide|NY-ESO-1 OLP4 (1 mg) was mixed in 5% dextrose solution in water with Poly-ICLC (1 mg) and Montanide ISA-51 VG (1 mL) and administered SC directly following the ipilimumab infusion every 3 weeks for 4 doses.
16146373|NCT01810016|Biological|NY-ESO-1 OLP4 Vaccine with Poly-ICLC|NY-ESO-1 OLP4 (1 mg) was mixed in 5% dextrose solution in water with Poly-ICLC (1 mg) and administered SC directly following the ipilimumab infusion every 3 weeks for 4 doses.
16146374|NCT01810003|Dietary Supplement|High DHA|10 week supplementation period
16146375|NCT01810003|Dietary Supplement|High EPA|10 week supplementation period
16146376|NCT01810003|Dietary Supplement|Placebo|10 week supplementation period
16146377|NCT01809990|Behavioral|Internet-delivered Cognitive Behavior Therapy|
16146378|NCT01809977|Procedure|collagen cross-linking procedure (total removal)|patients underwent Corneal collagen cross-linking procedure with totally corneal epithelium removing. Total removal was performed by mechanical debridement of the corneal epithelium over the central 9 mm.
16146379|NCT01809977|Procedure|collagen cross-linking procedure (partial removal)|patients underwent Corneal collagen cross-linking procedure with partially corneal epithelium removing. Partial removal was performed by removing a 3-mm width ring and leaving the central 3 mm of the cornea intact.
16146380|NCT01809964|Biological|ANT-1401|
16146381|NCT01809964|Biological|Vehicle|
16146382|NCT01809938|Other|Black tea|300ml of tea without milk
16146383|NCT01809938|Other|Tea with milk|250ml of black tea with 50ml of full fat milk
16146384|NCT01809925|Dietary Supplement|psyllium fiber 6.8g|Subjects will drink their assigned test product as quickly as possible immediately before eating breakfast at each visit.
16146385|NCT01809925|Dietary Supplement|placebo|Subjects will drink their assigned test product as quickly as possible immediately before eating breakfast at each visit.
16146386|NCT01809912|Drug|Recombinant human apolipoprotein(a) Kringle V|
16146387|NCT01809899|Behavioral|Enhanced consent procedure|Enhanced consent entails a more detailed consent procedure
16146388|NCT01809899|Behavioral|Consent as Usual|Routine informed consent procedures
16146389|NCT01809886|Drug|Sugammadex|50 patients, aged between 2 and 11 years scheduled for surgery and requiring muscle relaxation. The reversal will be made with sugammadex 4 mg/kg when surgery is over, maintaining a profound block level until that point in time (no response to TOF and PTC<2).
16146390|NCT01809886|Drug|Neostigmine|50 patients aged between 2 and 11 years scheduled for surgery and requiring muscle relaxation. The reversal will be made with neostigmine 0. 05 mg/kg and atropine 0.025 mg/kg (conventional reverser treatment) when surgery is over, maintaining a profound block level unit that point in time (no response to TOF and PTC<2).
16146391|NCT01809873|Behavioral|Performance based incentives|Facilities enrolled in the intervention arm will receive a financial incentive that is based on their diagnosis and prescription practices for malaria over that quarter. The intervention will last 12 months.
16146392|NCT01809860|Drug|isavuconazole|Oral
16146393|NCT01809860|Drug|sirolimus|Oral
16146394|NCT01809847|Drug|Ofatumumab|"Study treatment comprises eight weeks of induction therapy with ofatumumab in combination with high-dose dexamethasone. The first dose of ofatumumab is 300 mg followed by seven infusions of 2000 mg ofatumumab. Dexamethasone will be given orally at doses of 40 mg on days 1-4 in weeks 1, 3, 5, and 7. Patients who achieved a CR, PR shall proceed to maintenance therapy. Maintenance therapy consists of 6 monthly infusions of 1000 mg ofatumumab.
~An HLA-matched sibling donor or HLA-matched unrelated donor can be identified for approximately 70% of patients. Donor search will be completed within six weeks for 95% of the patients. Patients with a donor will proceed to allogeneic HCT as soon as possible prior to, or during maintenance therapy."
16146395|NCT01809834|Device|Etafilcon A|
16146396|NCT01809834|Device|Stenfilcon A|
16146397|NCT01809821|Behavioral|Online Sleep Education|
16146398|NCT01809808|Procedure|Surgery for acromegaly|(non-experimental) standard procedure
16146399|NCT01809808|Drug|Medications for acromegaly|(non-experimental) standard procedure
16146400|NCT01809808|Diagnostic Test|Total body magnetic resonance imaging|Subjects will undergo total body MRI with spectroscopy of the muscle and liver before and 3-6 months, 12 and 24 months after surgery or medical therapy for acromegaly.
16146401|NCT01809808|Procedure|Adipose Tissue Biopsy|Subjects will undergo biopsy of subcutaneous adipose tissue before and 12 and 24 months after surgery or medical therapy for acromegaly.
16146402|NCT01809795|Other|Blueberry Smoothie|
16146403|NCT01809795|Other|Sham Smoothie|
16146404|NCT01809769|Biological|Mesenchymal stem cells low-dose group|Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use
16146405|NCT01809769|Biological|Mesenchymal stem cells mid-dose group|Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use
16146406|NCT01809769|Biological|Mesenchymal stem cells high-dose group|Biological: Adipose tissue derived mesenchymal stem cells administrated for intra-articular use
16146407|NCT01809756|Other|Caphosol|Caphosol 4 times a day
16146408|NCT01809743|Drug|Regadenoson central -central|To test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. (adenosine is considered to be the golden standard).
16146409|NCT01809743|Drug|Regadenoson peripheral - peripheral|To test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. (adenosine is considered to be the golden standard).
16146410|NCT01809743|Drug|Regadenoson central - peripheral|To test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. (adenosine is considered to be the golden standard).
16146411|NCT01809743|Drug|Regadenoson peripheral - central|To test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. (adenosine is considered to be the golden standard).
16146412|NCT01809743|Drug|Adenosine|Fractional flow reserve is measured by inducing hyperaemia using central adenosine infusion.
16146413|NCT01809717|Other|Weight Lifting Exercises|
16146414|NCT01809691|Drug|TAK-700|300 mg, PO, twice daily
16146415|NCT01809691|Drug|Bicalutamide|50 mg, PO, q daily
16146416|NCT01809678|Behavioral|Smoking Cessation|Once weekly program of cognitive-behavioral therapy for smoking cessation
16146417|NCT01809678|Behavioral|Yoga|Twice weekly program of 1-hour Iyengar yoga classes
16146418|NCT01809678|Other|Wellness|Twice weekly program of 1-hour wellness classes on a variety of health topics.
16146419|NCT01809665|Device|ICD/CRT-P therapy|
16146420|NCT01809665|Other|MRI|
16146421|NCT01809652|Other|Remote Implant Support Capability|Use of audio and video telepresence and remote control of device programmer to allow implant to be supported from a remote location
16146422|NCT01809639|Drug|Progesterone|
16146423|NCT01809639|Drug|Placebo|Standard placebo
16146424|NCT01809626|Drug|Zolpidem|
16146425|NCT01809626|Other|Placebo|
16146426|NCT01809613|Procedure|Functional Magnetic Resonance Imaging (fMRI)|During the deep brain stimulation (DBS) surgery of the subthalamic nucleus within the thalamocortical basal ganglion, an additional lead extendor will be connected to the DBS electrode to allow externalization of the lead. Following confirmation of electrode location with MRI, a series of fMRI scans will be run. Total scanning time will be limited to 35 minutes.
16146427|NCT01809600|Other|No intervention (observational study)|
16146428|NCT01809587|Device|IQP-PO-101|
16146429|NCT01809561|Procedure|tissue biopsy during surgical treatment|The samples collected will test for histological diagnosis of endometriosis and verification tests will be done to characterize the telomeres array and telomerase levels and other characteristics for genomic instability such as spontaneous aneuploidy.
16146430|NCT01809548|Other|Early intervention group|solid food will be introduced between week 10 and 12
16146431|NCT01809548|Other|Late intervention group|solid food is introduced between 16-18th week of gestation corrected for prematurity
16146432|NCT01809535|Device|Wilson-Cook four shooter saeed multi-band ligator|Patients in the Monthly group were received EVL at 28-day treatment intervals.Orally 20 mg of rabeprazole (Pariet®) once a day for 2 weeks was given to hasten post-EVL ulcer healing in each treatment session. Once esophageal varices were obliterated, surveillance endoscopy was done every 3 months for one year, then every 6 months to check for recurrent varices.
16146433|NCT01809535|Device|Wilson-Cook four shooter saeed multi-band ligator|Patients in the Biweekly group were received EVL at 14-day treatment intervals.Orally 20 mg of rabeprazole (Pariet®) once a day for 2 weeks was given to hasten post-EVL ulcer healing in each treatment session. Once esophageal varices were obliterated, surveillance endoscopy was done every 3 months for one year, then every 6 months to check for recurrent varices.
16146434|NCT01809522|Procedure|Posterior reconstruction of the rhabdosphincter|
16146435|NCT01809509|Procedure|Endometrial biopsy|
16146436|NCT01809496|Behavioral|Informational Counseling|
16146437|NCT01809496|Behavioral|Patient Centered Counseling|
16146438|NCT01809483|Device|Bandage contact lens|Bandage contact lens : contact lenses (material senofilcon A; base curve 8,8 mm; power - 0,50; diameter 14 mm)
16146439|NCT01809483|Device|Pressure patching|Pressure patching : using 2 pieces of sterile gauze. The first gauze placed vertically and the second placed horizontally, then fixed with adhesive tape so that eyelid can not move.
16146440|NCT01809470|Behavioral|FIFA2013|Playing FIFA2013 for 1 hour
16146441|NCT01809470|Behavioral|Call of Duty|Playing Call of Duty for 1 hour
16146442|NCT01809470|Behavioral|Watching TV|Watching TV for 1 hour
16146443|NCT01809457|Other|educational poster|educational poster for dental trauma
16146444|NCT01809444|Drug|Prednisone+placebo of Doxycycline|Prednisone: 50 mg/d for 14 day, tailed by 40 mg/d for 14 day, 30 mg/d for 28 day, 20 mg/d for 28 day, 15 mg/d for 14 day, 10 mg/d for 14 day, in total 16 weeks; Placebo of doxycycline: administered for 16 weeks
16146445|NCT01809444|Drug|Doxycycline+placebo of Prednisone|Doxycycline: 50 mg PO per day for 12 weeks, and placebo for another 4 weeks; Placebo of prednisone: administered for 16 weeks.
16146446|NCT01809431|Behavioral|Intervention|Using a two-group, repeated measures experimental design, this proposed study will test a 14-week intensive intervention on the benefits of breastfeeding, understanding gestational diabetes and risk of progression to prediabetes and type 2 diabetes, nutrition and exercise education, coping skills training, and physical activity (Phase I) and 3 months of continued monthly contact (Phase II) to help overweight women diagnosed with gestational diabetes improve metabolic, clinical, weight, adiposity, health behaviors and self-efficacy.
16146447|NCT01809418|Device|keePAP|
16146448|NCT01809392|Drug|decitabine|36 mg/m2 on day 42 after transplantation and administered daily for 5 consecutive days every 28 days for up to a total of 10 cycles
16146449|NCT01809379|Drug|chemotherapy with doxorubicin and cisplatin|intraperitoneal chemotherapy applied as an aerosol and under pressure
16146450|NCT01809366|Procedure|seminal plasma insemination|
16146451|NCT01809353|Drug|JNJ-54452840|Single intravenous (medication is injected into a vein) doses of 20 mg, 80 mg, and 240 mg
16146453|NCT01809340|Drug|Minocycline|In the 12-day open-label treatment phase, patients will self administer oral minocycline 200 mg on Day 1, 100 mg twice daily on Days 2 to 11, and 100 mg on the morning of Day 12. In the 6-week blinded treatment phase, responders may self administer oral minocycline 100 mg twice daily from the evening of Day 12 for up to 6 weeks (Day 54), or until relapse, whichever comes first. In the 6-week open-label treatment phase, non-responders may self administer oral minocycline 100 mg twice daily from the evening of Day 12 for up to 6 weeks (Day 54).
16146454|NCT01809340|Drug|Placebo|Patients in the 6-week blinded treatment phase, may self administer placebo twice daily from the evening of Day 12 for up to 6 weeks (Day 54), or until relapse, whichever comes first.
16146455|NCT01809340|Drug|Ketamine|In the 12-day open-label treatment phase, all patients will receive 1 IV infusion of 0.5 mg/kg ketamine over 40 minutes on Days 1, 3, 5, 8, 10 and 12.
16146456|NCT01809327|Drug|Canagliflozin 100 mg|One 100 mg capsule taken orally (by mouth) once daily either before the morning meal (for the Canagliflozin 100 mg arm) or with the evening meal (for the Canagliflozin 100 mg + Metformin XR arm).
16146457|NCT01809327|Drug|Canagliflozin 300 mg|One 300 mg capsule taken orally (by mouth) once daily either before the morning meal (for the Canagliflozin 300 mg arm) or with the evening meal (for the Canagliflozin 300 mg + Metformin XR arm).
16146458|NCT01809327|Drug|Metformin XR|One 500 mg tablet (Day 1 up to week 1); two 500 mg tablets (Week 1 up to Week 3); three 500 mg tablets (Week 3 to Week 6); four 500 mg tablets (Week 6 to Week 9). Tablets will be administered with the evening meal.
16146459|NCT01809314|Drug|Epoetin beta|Treatment will be given according to standard of care and the Summary of Product Characteristics during the study.
16146460|NCT01809301|Drug|Niaspan|
16146461|NCT01809301|Drug|TRIA-662|
16146462|NCT01809275|Drug|QBECO|
16146463|NCT01809275|Drug|Placebo|
16146464|NCT01809262|Drug|single dose of 5 mcg|solution for inhalation
16146465|NCT01809262|Drug|single dose of placebo|solution for inhalation
16146466|NCT01809262|Drug|single dose of 40 mcg|solution for inhalation
16146467|NCT01809262|Drug|single dose of 20 mcg|solution for inhalation
16146468|NCT01809262|Drug|single dose of 2 mcg|solution for inhalation
16146469|NCT01809262|Drug|single dose of 10 mcg|solution for inhalation
16146470|NCT01809236|Biological|Conbercept|intravitreal injection of 0.5 mg Conbercept
16146471|NCT01809223|Drug|conbercept, Fixed|intravitreal injection of 0.5 mg conbercept per month, fixed injection
16146472|NCT01809223|Drug|conbercept, PRN|intravitreal injection of 0.5 mg conbercept as need, PRN
16146473|NCT01809223|Other|sham injection|sham intravitreal injection per month, fixed injection
16146474|NCT01809210|Drug|selumetinib|2 x 25mg capsules bd continuously in cohort 1 (with gemcitabine and cisplatin). If tolerated - next cohort 3 x 25mg capsules bd continuously. if higher doses are explored, required number of capsules will be provided. Option to administer on D2-19 of each 21 day cycle if required to assess tolerability of combinations with chemotherapy
16146475|NCT01809210|Drug|gemcitabine|1250 mg/m2 iv on Day 1 and 8 of each 21 day cycle. If combination not tolerated, option to give 1000 mg/m2 iv on Day 1 and Day 8 of each 21 day cycle
16146476|NCT01809210|Drug|cisplatin|75 mg/m2 iv on Day 1 of each 21 day cycle. If combination not tolerated, option to give 50 mg/m2 iv on Day 1 or 25mg/m2 iv on Day 1 and Day 8 of each 21 day cycle
16146477|NCT01809210|Drug|carboplatin|If it is not possible to identify a tolerable combination of selumetinib, gemcitabine and cisplatin, cisplatin may be replaced with carboplatin (AUC5) iv on Day 1 of each 21 day cycle
16146478|NCT01809210|Drug|pemetrexed|Gemcitabine may be replaced with pemetrexed 500 mg/m2 iv on Day 1 of each 21 day cycle.
16146479|NCT01809197|Device|Lotrafilcon B contact lenses|Silicone hydrogel contact lenses for near/far-sightedness, astigmatism, and/or presbyopia, replaced per manufacturer's instructions
16146480|NCT01809197|Device|Senofilcon A contact lenses|Silicone hydrogel contact lenses for near/far-sightedness, astigmatism, and/or presbyopia, replaced per manufacturer's instructions
16146481|NCT01809197|Device|OPTI-FREE PureMoist Multi-Purpose Disinfecting Solution (MPDS)|Multi-purpose disinfecting solution for contact lens care, used per manufacturer's instructions
16146482|NCT01809197|Device|Habitual Multi-Purpose Solution (MPS)|Multi-purpose solution for contact lens care according to subject's habitual brand, used per manufacturer's instructions
16146483|NCT01809184|Drug|insulin 287|Orally administered insulin 287. The subjects will be dosed in the fasting state and receive one single dose followed by a 24-hour euglycaemic glucose clamp.
16146484|NCT01809184|Drug|insulin glargine|Insulin glargine administered subcutaneously (s.c., under the skin) at fixed dose levels.
16146485|NCT01809184|Drug|placebo|Oral placebo adminstered corresponding to insulin 287 treatment
16146486|NCT01809171|Drug|Vitamin D3|ampoule
16146487|NCT01809171|Drug|Placebo|ampoule
16146488|NCT01809158|Drug|minocycline|
16146489|NCT01809158|Drug|placebo|
16146490|NCT01809145|Other|MELISA test|MELISA test for hypersensitivity to metals in sarcoidosis
16146495|NCT01809119|Procedure|Partial nephrectomy|
16146496|NCT01809106|Drug|Morphine|60 mg /24 ore
16146497|NCT01809106|Drug|Fentanyl|25 microg/h
16146498|NCT01809106|Drug|Buprenorphine|35 microg/h
16146499|NCT01809106|Drug|Oxycodone|40 mg /24 ore
16146500|NCT01809093|Biological|Blood draw|3-4 tablespoons of blood will be drawn, one time.
16146501|NCT01809067|Other|Lavender aromatherapy inhalers|Patients will self-administer lavender aromatherapy from hand held inhalers containing lavender essential oil.
16146502|NCT01809054|Drug|Arixtra|
16146503|NCT01809054|Device|Pneumatic compression stockings|Pneumatic compression stockings (MCS, Active Care, medical compression systems Inc., Israel)
16146504|NCT01809054|Drug|Aspirin|
16146505|NCT01809041|Drug|Sevoflurane|
16146506|NCT01809041|Drug|propofol|
16146507|NCT01809041|Drug|remifentanil|
16146509|NCT01809028|Procedure|EUS FNA with 4 passes|biopsy with 4 passes
16146510|NCT01809002|Biological|Processed Nerve Allograft (human)|
16146511|NCT01809002|Device|Collagen Nerve Cuff|Bovine collagen based nerve cuff
16146512|NCT01808989|Other|Exercise oxymetry|
16146513|NCT01808976|Other|Problem Solving Therapy|this is a mobile app that participants use to solve problems. It will guide participants through a stepwise process for identifying a means for creating action plans.
16146514|NCT01808976|Behavioral|Evolution|This is a therapeutic video game that targets the cognitive control network, associated with depression. Participants are expected to play the game daily for 20 minutes over 4 weeks.
16146515|NCT01808976|Behavioral|Basic health push app|This is an app that send daily tips for improving your mood.
16146516|NCT01808950|Drug|0.06% Resiquimod Gel - A|single 60mg dose
16146517|NCT01808950|Drug|0.06% Resiquimod Gel - B|single 100mg dose
16146518|NCT01808950|Drug|0.06% Resiquimod Gel - C|shave biopsy of BCC followed by single 100mg dose
16146519|NCT01808937|Other|Morphea|
16146520|NCT01808911|Drug|Steroid + cyclophosphamide|
16146521|NCT01808911|Drug|Steroid + rituximab|
16146522|NCT01808898|Procedure|Local Anaesthetic|On the day of the procedure and before the patients are treated, a designated clinician will draw up the local anaesthetic (2mls consisting of 1ml of 3% mepivacaine (short / medium acting) and 1ml of 0.5% bupivacaine (long acting)
16146523|NCT01808885|Drug|olesoxime (TRO19622)|"olesoxime (3 caps: 495 mg, od) will be administered orally as 165 mg soft capsules for 6 months.
~Investigational products will be allocated in a 1:1 ratio from Baseline/Visit 0 to Week 24 (Visit 3/Final Visit)."
16146524|NCT01808885|Drug|placebo|placebo capsule shells with identical appearance as the active compound TRO19622
16146525|NCT01808859|Device|Tourniquet|hyperbaric bupivacaine 12.5-15 mg Celecoxib 400 mg and paracetamol 1 g will be given preoperatively. Postoperatively celecoxib 200 mg x 2 and paracetamol 1 g/6 h is given is given for 2 weeks.
16146526|NCT01808820|Biological|Dendritic Cell Vaccine|Between 1.2 to 12 million DC per dose administered once a week via intradermal injection for 4 weeks.
16146527|NCT01808820|Biological|Tumor Lysate|Post-DC Vaccine therapy. Up to 1.5 mg of Lysate of tumor per dose administered via intradermal injection at intervals defined by study protocol.
16146528|NCT01808820|Drug|Imiquimod|5% topical cream applied to vaccine site before and after administrations of DC vaccine or lysate
16146529|NCT01808820|Procedure|Leukapheresis|Baseline, post-surgery blood draw via catheter to obtain peripheral blood mononuclear cells (PBMCs) from which Dendritic cells will be obtained.
16146530|NCT01808794|Device|Mucograft|Mucograft Collagen Matrix
16146531|NCT01808794|Device|Dynamatrix|Dynamatrix
16146532|NCT01808781|Other|Exercises plus walking program|"Exercise group Consist of functional exercises such as mini-squats, sit to stand, and exercises with use of thera-bands. For each exercise, participants will be taught to perform the concentric phase forcefully and as fast as they can and return to the initial position slowly and with control. Participants will be asked to perform the exercises 3 times per week as a home exercise program daily throughout the 8-week intervention period. Additionally, they will be asked to wear a pedometer daily throughout the 8-week intervention to monitor steps. A step goal will be provided to gradually increase daily to become somewhat active or active by the end of the 8-week intervention."
16146533|NCT01808781|Other|Walking only program|Participants will be asked to wear a pedometer and instructions for use just as the exercise group. They will also will given a step goal just as the participants in the exercise group and will similarly be asked to record number of steps form their pedometer in a daily log along with the minutes of moderate and vigorous physical activity throughout the 8-week intervention period.
16146534|NCT01808768|Drug|Alcaftadine|Alcaftadine 0.25% one dorp each eye daily for 1-2 weeks.
16146535|NCT01808755|Dietary Supplement|D Mannose|1 gr. every 8 hours
16146536|NCT01808755|Drug|trimethoprim/sulfamethoxazole|one cp b.i.d. for 5 days. Then one week of antibiotic every 4 weeks for the following 23 weeks
16146537|NCT01808742|Device|Treatment with CryoTouch III Device|Bilateral forehead treatment with CryoTouch III device on the temporal branch of the facial nerve. Subject will be treated once and may be retreated up to 7 days after initial treatment.
16146538|NCT01808716|Device|Low-level laser therapy (808nm) and exercise|Use of low-level laser therapy(LLLT)or placebo-LLLT applied on biceps brachii for muscle damage recovery
16146539|NCT01808703|Device|PeriZone PerioPatch|The PeriZone PerioPatch is an approved barrier or device product intended for the management of all types of oral wounds, injuries and ulcerations of the gingival and oral mucosa (510K number K103054). PerioPatch devices will be applied adjunctively following scaling and root planing).
16146540|NCT01808703|Procedure|Scaling and root planing alone|Following completion of the Baseline examination, all randomized patients will receive full mouth scaling and root planing at a maximum of two visits within a 14-day time period (Weeks -2 to 0). Use of hand curettes and/or ultrasonic instruments will be permitted. Local or topical anesthesia may be used for patient comfort at the discretion of the clinician performing the scaling and root planing.
16146541|NCT01808690|Drug|Metformin|
16146542|NCT01808690|Drug|Placebo|
16146543|NCT01808677|Other|Thoracic Reirradiation Registry|Data collected in the registry includes patient characteristics/demographics, disease characteristics, treatment details (radiation, chemotherapy, surgery, etc.), toxicity rates, and survival outcomes.
16146544|NCT01808664|Behavioral|Standardized Patient Instructor Intervention|"In each case, patients will harbor underlying concerns about a serious underlying condition (e.g., either disc herniation or osteoporosis) and will request inappropriate tests. Standardized patient instructors (SPIs) will portray new patients visiting the clinic for the first time, and electronic medical records will be identical to that of actual new patients.
~During the initial part of intervention visits, SPIs will assess the extent to which PCPs engage in patient-centered techniques specified in the final intervention model. SPIs will then break of their role and either teach or reinforce PCP use of the techniques, presenting techniques in a logical sequence while emphasizing flexibility in their use. SPIs will use scripts to deliver the interventions, providing opportunities for PCPs to ask questions, discuss concepts, and practice (by role playing) patient-centered techniques."
16146590|NCT01808339|Drug|Placebo|Placebo in single strip to be administered via dry powder inhaler in the morning and evening for 14 days (+/- 2 days).
16146545|NCT01808664|Behavioral|Control|"In the latter half of visits with control PCPs, standardized patient instructors will share information with physicians regarding the acute low back pain self-care and bone health, but will not discuss patient-centered techniques or conduct training. The total duration of the control information sharing will be about one-third the SPI intervention to enhance patient-centeredness."
16146546|NCT01808651|Drug|Fluoxetine|Administered orally
16146547|NCT01808638|Drug|Atu027 & gemcitabine in lead in safety period|Subjects will be treated in a 28-day cycle with Atu027 twice weekly for 4 weeks and gemcitabine once weekly for the first three weeks.
16146548|NCT01808638|Drug|Atu027 & gemcitabine in treatment arm 1|"Subjects will be treated in a 28-day cycle with Atu027 and gemcitabine once weekly for three consecutive weeks (on days 1, 8, and 15). During week four no treatment is administered.
~Treatment will be continued in consecutive 28-day cycles until unacceptable toxicity or disease progression occurs."
16146549|NCT01808638|Drug|Atu027 & gemcitabine in treatment arm 2|"Subjects will be treated in a 28-day cycle with gemcitabine once weekly (on days 4, 11, and 18) and Atu027 twice weekly (on days 1, 4, 8, 11, 15, 18, 22, and 25). The 28-day combination cycle is followed by a 28-day gemcitabine monotherapy cycle.
~Treatment will be continued in consecutive 28-day cycles until unacceptable toxicity or disease progression occurs."
16146550|NCT01808625|Other|HYPERBARIC OXYGEN STIMULATION|30 daily sessions, 6 days a week of 90 min exposure to 100% oxygen at 2 ATA.
16146551|NCT01808612|Drug|Fluoxetine|
16146552|NCT01808612|Drug|Placebo|
16146553|NCT01808599|Drug|Chlorambucil|
16146554|NCT01808599|Drug|Rituximab i.v.|
16146555|NCT01808599|Drug|Rituximab s.c.|
16146556|NCT01808586|Procedure|Betamethasone|6 mg/mL injected into the facet joint as dictated by modified dual-comparative medial branch block diagnostic protocol
16146557|NCT01808586|Procedure|Dexamethasone|4mg/mL
16146558|NCT01808586|Procedure|Intramuscular Lidocaine|2%
16146559|NCT01808586|Behavioral|Home Exercise|Standardized home exercise program
16146560|NCT01808573|Drug|neratinib|
16146561|NCT01808573|Drug|capecitabine|
16146562|NCT01808573|Drug|lapatinib|
16146563|NCT01808560|Device|LipiFlow Pre-Treatment|The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye.
16146564|NCT01808560|Device|LipiFlow Post-treatment|The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye.
16146565|NCT01808547|Drug|ISV-303|0.075% bromfenac in DuraSite dosed BID
16146566|NCT01808547|Other|DuraSite Vehicle|DuraSite vehicle dosed BID
16146567|NCT01808534|Drug|palifosfamide|Given IV
16146568|NCT01808521|Drug|N-Acetylcysteine|IV administration of N-Acetylcysteine at 150mg/kg over 60 min first, then if well tolerated, 150mb/kg over 17 hours
16146569|NCT01808508|Device|Continuous positive airway pressure|Continuous positive airway pressure is a machine used with sleep which compresses air delivered via a nasal mask and thus helps stent the airway open.
16146570|NCT01808508|Device|Sham or placebo continuous positive airway pressure|Sham or placebo CPAP is a machine used instead of therapeutic CPAP. This machine is similar to a therapeutic CPAP machine but has built in leaks and does not deliver pressure. It is not effective in treating OSAS.
16146571|NCT01808495|Drug|Mitomycin C|
16146572|NCT01808482|Drug|Part A: 100 mg/mL GSK2618960|100 mg/mL GSK2618960 solution for IV Infusion up to 1 hr except for the 1st dose (IV bolus) and 2nd dose (IV infusion over 5 min) of Part A
16146573|NCT01808482|Drug|Part A: matching placebo|Matching placebo
16146574|NCT01808482|Drug|Part B: Dose of GSK2618960 decided from Part A|100 mg/mL GSK2618960 solution for IV Infusion in repeat dose decided from Part A
16146575|NCT01808482|Drug|Part B: matching placebo|Matching placebo
16146576|NCT01808482|Drug|Part C: Dose of GSK2618960 decided from Part A and B|100 mg/mL GSK2618960 solution for IV Infusion in repeat dose decided from Part A and B
16146577|NCT01808469|Biological|Monoclonal antibody|
16146578|NCT01808456|Biological|influenza trivalent inactive vaccine|one time IM injection of standard influenza vaccine to measure immunogenicity, safety, and efficacy in organ transplant recipients
16146579|NCT01808456|Biological|influenza trivalent inactive vaccine high dose|one time IM injection of high dose influenza vaccine to measure immunogenicity, safety, and efficacy in organ transplant recipients
16146580|NCT01808443|Other|Cryotherapy|up to a maximum of four treatments every 21-28 days
16146581|NCT01808443|Other|laser|up to a maximum of four treatments every 21-28 days
16146582|NCT01808430|Procedure|VATS for confirmed non-small cell lung cancer (NSCLC)|Video-Assisted Thoracoscopic Surgery for NSCLC patients
16146583|NCT01808417|Drug|Near Infrared Imaging|The intervention to be administered is the drug indocyanine green.
16146584|NCT01808404|Behavioral|Web-Based Guided Self-Help|"The intervention will involve counselors using the web-based guided self-help program with their student clients. Counselors will complete a web-based training followed by a period of time in which they will monitor and guide students in completing the program. Students will access a series of three web-based lessons in which they will receive an intervention based on Acceptance and Commitment Therapy (ACT) focused on personal values, acceptance of difficult emotions, and mindfulness."
16146585|NCT01808378|Drug|Expanded adipose-derived stem cells|Local injection of autologousadipose derived stem cells
16146586|NCT01808365|Procedure|Posterior pharyngeal swab|Posterior pharyngeal swabs will be tested for the presence of N. meningitidis.
16146587|NCT01808365|Other|Data collection|Collection of socio-demographic data and recording of serious adverse events by interview of subjects or subjects' parents/legally acceptable representatives.
16146588|NCT01808352|Drug|FTC/TDF|All participants will be offered once daily oral emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (FTC/TDF) combined with C4.
16146589|NCT01808339|Drug|Fluticasone Furoate (FF)|Inhalation powder 100 microgram per blister strip to be administered via dry powder inhaler either in the morning (AM dose with FF and PM dose with +/-2 days).
16146750|NCT01807078|Drug|Ezetimibe|10 mg p.d. of ezetimibe
16146591|NCT01808326|Drug|chlorambucil, tablets|2mg tablets, chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 cycles
16146592|NCT01808313|Drug|ambrisentan|Ambrisentan 5 mg will be administered to eligible subjects for 12 weeks
16146593|NCT01808300|Drug|Pregabalin 300mg, Thioctic acid 600mg|"A: Pregabalin - Pregabalin 300mg will be administered orally twice a day for 3 days
~B: Thioctic acid - Thioctic acid 600mg will be administered orally once a day for 3 days
~C: Pregabalin plus Thioctic acid - Pregabalin plus Thioctic acid same way as A and B"
16146594|NCT01808287|Device|Edwards SAPIEN 3 Transcatheter Heart Valve|The Edwards SAPIEN 3 Transcatheter Heart Valve (THV) System is indicated for use in symptomatic patients (intermediate or higher operable risk) with severe aortic stenosis requiring aortic valve replacement (AVR).
16146595|NCT01808274|Device|Edwards CENTERA Self-Expanding Transcatheter Heart Valve|The Edwards CENTERA Transcatheter Heart Valve (THV) System is indicated for use in symptomatic patients (high surgical risk) with severe aortic stenosis requiring aortic valve replacement (AVR).
16146596|NCT01808261|Drug|GSK249320 100/mg|Clear to opalescent, colorless to pale yellow or pale brown, and is supplied as a sterile, concentrated solution (1000mg/vial). GSK249320 is for IV use only.
16146597|NCT01808261|Drug|Placebo|Placebo is a clear, colorless solution (50mM acetate buffer, pH 5.5 containing 0.02% (w/v) polysorbate-80 and made isotonic with 111.2 mM sodium chloride). Placebo is for intravenous (IV) use only.
16146598|NCT01808248|Drug|SOF|Sofosbuvir (SOF) 400 mg tablet administered orally once daily
16146599|NCT01808248|Drug|PEG|Peginterferon alfa 2a (PEG) 180 μg administered once weekly by subcutaneous injection
16146600|NCT01808248|Drug|RBV|Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
16146601|NCT01808235|Behavioral|Oral Health Intervention|The dental hygienist will assess the IMD's tooth brushing technique and will provide specific feedback on the tooth brushing technique, including areas of the dentition missed in brushing. The IMDs will be given a powered toothbrush that records time, date and duration of toothbrushing activity, along with the direction and extent of motion of the toothbrushing activity. In addition, use of interdental cleaning aids will be recommended. The dental hygienist will review the findings from the oral health evaluation with the IMDs and caregivers, and provide detailed feedback on treatment and prevention of the oral health conditions and symptoms. The dental hygienist or study coordinator will call subjects by telephone biweekly to monitor oral hygiene practices and to provide coaching, if needed. Oral hygiene technique assessments will be conducted again three months after the first visit, and once more three months later, at the end of the intervention.
16146602|NCT01808222|Drug|FACBC|Participants will receive a bolus of anti-[18F]FACBC injected IV over 1-2 minutes. The dosage will be approximately 10.0 millicuries (mCi) (3.70 x 108 becquerel (Bq)).
16146603|NCT01808209|Device|stenfilcon A|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
16146604|NCT01808209|Device|filcon II 3|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
16146605|NCT01808196|Drug|Losartan Potassium|The dose of study drug is dependent on body weight and tolerance but did not exceed 100 mg.
16146606|NCT01808183|Device|Near Infrared Spectroscopy Pads|NIRS pads are commonly used as a noninvasive method of assessing deep tissue perfusion, originally designed to assess cerebral perfusion during anesthesia.
16146607|NCT01808170|Procedure|Laparoscopic ovarian cystectomy|will be performed using video control under general anesthesia, pneumoperitoneum is induced by carbon dioxide, with three 5-mm trocars in the lower abdomen and a 10-mm intraumbilical main trocar, and we will use 5-mm scissors and graspers, and Ringer's lactate solution for irrigation. Before initiating ovarian surgery, the ovaries are completely freed with obtuse and sharp dissection.after a cleavage plane between the cyst wall and ovarian cortex is identified, the ovaries are pulled slowly and gently in opposite directions by means of two a traumatic grasping forceps. After removing the pseudo capsule from the abdominal cavity, selective minimal (15 watt) bipolar coagulation of bleeding is performed, without excessive coagulation of the surgical defect to avoid damaging the ovary.
16146608|NCT01808170|Procedure|laparoscopic cyst deroofing|will be performed using video control under general anesthesia, pneumoperitoneum is induced by CO2, with three 5-mm trocars in the lower abdomen and a 10-mm intraumbilical main trocar, and we will use 5-mm scissors and graspers, and Ringer's lactate solution for irrigation. Before initiating ovarian surgery, the ovaries are completely freed with obtuse and sharp dissection. after mobilizing the ovary, the contents of the cyst is removed with the suction-irrigator probe and the cavity is irrigated. The inside of the cyst is evaluated and the portion of ovarian cortex involved with endometriosis is removed. Small blood vessels from the ovarian bed and bleeding from the ovarian hilum can be controlled with bipolar electro coagulation (15 watt). Low-power bipolar coagulation applied to the inside wall of the redundant ovarian capsule
16146609|NCT01808157|Drug|CT327 ointment|
16146610|NCT01808157|Drug|placebo|
16146611|NCT01808144|Drug|lesinurad|Tablets, 400 mg once daily (QD)
16146612|NCT01808144|Drug|lesinurad|Tablets, 200 mg QD
16146613|NCT01808144|Drug|febuxostat|Tabletsm 80 mg QD
16146614|NCT01808131|Drug|Lesinurad|Tablets, 200 mg QD
16146615|NCT01808131|Drug|Lesinurad|Tablets, 400 mg QD
16146616|NCT01808118|Biological|adalimumab|40 mg every other week
16146617|NCT01808118|Biological|Placebo|every other week
16146618|NCT01808105|Other|Control Formula|Feeding ad libitum
16146619|NCT01808105|Other|Experimental Formula 1|Feeding ad libitum
16146620|NCT01808105|Other|Experimental Formula 2|Feeding ad libitum
16146621|NCT01808105|Other|Human Milk|Feeding ad libitum
16146622|NCT01808092|Drug|ceftazidim-avibactam (CAZ-AVI, experimental product)|2000mg ceftazidime plus 500mg avibactam
16146623|NCT01808092|Drug|meropenem (active comparator)|1000mg of Meropenem
16146624|NCT01808079|Other|Laboratory Biomarker Analysis|Correlative studies
16146625|NCT01808066|Device|Groundskeeper|Groundskeeper is a product developed for helping players develop skills to increase focus and attention. The game is played on small Sifteo Cubes that have sensors that react to you and each other. There are new games that might help children with ADHD and Autism learn to better focus and keep attention on a task.
16146626|NCT01808053|Device|BodyGuardian remote health monitoring system|The remote health management system connects personal health sensors with secure mobile communication devices. It is also able to give immediate feedback to the user. The solution is a multi-tiered mobile health platform. The front-end includes an adhesive snap-strip body sensor (BodyGuardian) that can measure HR, ECG, respiration rate (RR), and activity which is FDA approved for detection of non-lethal cardiac arrhythmias. It can wirelessly communicate with off-body sensors such as a BP cuff and scale to incorporate BP and weight data based on automated algorithms and can solicit symptoms from the user. It can also be used as an event recorder inputting symptoms and recording simultaneous physiologic data.
16146627|NCT01808040|Drug|TAK700|dose is dependant on dose escalation timepoint and dose expansion cohort dose will be the RP2D determined based on the dose escalation cohort final dose recommendation
16146628|NCT01808014|Drug|nefopam|The chief investigator prepared the medications according to the selected randomized table, and investigators who were not involved in medication preparation recorded the pain and prevalence of complications in study subjects. The double-blind restriction was lifted if the patient withdrew from the study, and the next patient was classified into a group while blinded by using the randomized table.Intramuscular midazolam 0.05 mg/kg was administered as a premedication, and then a blood pressure machine, electrocardiogram, and pulse oximeter were connected to the patient in the operating room.
16146629|NCT01807988|Behavioral|iCBT|Internetbased cognitive behavior therapy (iCBT) contains interventions that will help the participant to change her behavior to experience more positive reinforcement in daily life and also to challenge her negative patterns of thought. There are also information and exercices to improve sleep, increase physical activity, train mindfulness, handle anxiety and to learn about depression.
16146630|NCT01807975|Other|Forced oscillation|
16146631|NCT01807962|Drug|rapidocain and bethametsaone|"lidocaine (Rapidocain(R)): 4ml of 1% Lidocaine
~bethametasone (Diprophos): 1ml ampoule (containing 5mg/ml dipropionate de betamethasone and 2mg/ml phosphate disodique de betamethasone)"
16146632|NCT01807962|Drug|sterile saline|Placebo = 5ml of sterile saline solution
16146633|NCT01807949|Drug|Placebo|Matching placebo tablet
16146634|NCT01807949|Drug|Lumacaftor Plus Ivacaftor Combination|Fixed dose combination tablet
16146635|NCT01807949|Drug|Ivacaftor|Film-coated tablet
16146636|NCT01807936|Procedure|Lymphadenectomy|
16146637|NCT01807923|Drug|Lumacaftor Plus Ivacaftor Combination|Fixed dose combination tablet
16146638|NCT01807923|Drug|Ivacaftor|Film-coated tablet
16146639|NCT01807923|Drug|Placebo|Matching placebo tablet
16146640|NCT01807910|Drug|methyl-D9-choline|Subjects in both arms will be infused with methyl-D9-choline in order to assess the biosynthesis and kinetics of secretory lipoprotein phospholipids.
16146641|NCT01807897|Device|Continuous positive airway pressure|Nocturnal continuous positive airway pressure, titrated to minimize apnea-hypopnea index
16146642|NCT01807897|Device|Nocturnal supplemental oxygen|Nocturnal supplemental oxygen, titrated to 2-4 liters/minute with target of eliminating nocturnal hypoxemia
16146643|NCT01807897|Behavioral|Healthy Lifestyle and Sleep Education|A 60-minute educational intervention with slide show and printed materials, educating the patient in healthy sleep habits and heart-healthy lifestyle
16146644|NCT01807884|Procedure|Optimized oral care|An optimization of the oropharyngeal suction procedure will include use of a subglottic drainage in a specified order: 1. subglottic suction, 1.oral suction followed by mouth care 3. subglottic suction 4. tracheal suction
16146645|NCT01807884|Other|Routine oral care|Oral suction followed by mouth care and tracheal suction without any subglottic suction
16146646|NCT01807871|Drug|nicotine patch, experimental use|nicotine patch-transdermal, continue during lapses Nicotine patches are used according to normal package label, except if the participant lapses and smokes, they will continue to use the patch.
16146647|NCT01807871|Drug|nicotine patch, labeled use|nicotine patch-transdermal, discontinue during lapses Participants will use the nicotine patch while abstinent, but will remove the patch if there is a lapse and smoking resumes. This is the use indicated on current FDA approved labeling.
16146648|NCT01807858|Dietary Supplement|Bifidobacterium lactis|5 billion active Bifidobacterium lactis
16146649|NCT01807858|Dietary Supplement|Bifidobacterium lactis plus İnülin|5 billion Bifidobacterium lactis plus 900 mg İnülin per day will be given
16146650|NCT01807858|Other|Maltodextrin|Maltodextrin
16146651|NCT01807858|Dietary Supplement|İnulin|900 mg inulin per day will be given
16146652|NCT01807845|Dietary Supplement|enriched skimmilk with VD|enriched skimmilk with VD
16146653|NCT01807845|Dietary Supplement|Skimmilk enriched with VD wherein the VD will be emulsified using Tween 80|Skimmilk enriched with VD wherein the VD will be emulsified using Tween 80
16146654|NCT01807845|Dietary Supplement|Placebo: un-enriched skimmilk.|Placebo: un-enriched skimmilk
16146655|NCT01807832|Other|capsaicin challenge|
16146656|NCT01807819|Other|Heart Failure|Patients will undergo echocardiogram and exercise testing. Two year phone follow-up.
16146657|NCT01807806|Behavioral|Role-playing game|Eligible participants will be invited to engage with a role-playing game for 30 minutes. The role play presents situations where a service member/veteran interacts with family or friends.
16146658|NCT01807793|Behavioral|Psychoeducation|
16146659|NCT01807780|Biological|biological monitoring|
16146660|NCT01807767|Drug|Everolimus, Myfortic and Tacrolimus|"Tacrolimus discontinued (within 8 weeks of initiation of everolimus conversion).
~Everolimus 1mg BID started (targeted trough 6-12ng/mL). Patients must have an everolimus concentration between 6-12ng/mL before tacrolimus is discontinued.
~Myfortic 360-720 mg BID"
16146661|NCT01807767|Drug|Myfortic and Tacrolimus|Myfortic BID 360-720 mg Tacrolimus (5-12ng/mL)
16146662|NCT01807754|Procedure|X-ray and ultrasound imaging scanning|Digital tomosynthesis mammogram uses a low radiation dose, taking x-ray pictures of the breast from many angles to make a 3D(dimensional)image. The participant will be seated and her breast positioned as in a normal mammogram, though with reduced pressure. The x-ray tube will move quickly above the breast to take the images. Then, an ultrasound scan will be done using gel on your breast to assist in acquiring quality imaging.
16146748|NCT01807104|Procedure|Anterior versus Posterior Approach for total hip replacement|Compare results of total hip arthroplasty performed through either an anterior or posterior surgical approach
16147252|NCT01803074|Drug|Atazanavir|Atazanavir
16146663|NCT01807754|Procedure|Photoacoustic imaging scans for breast cancer screening|The participant will be seated in front of the laser device with the breast positioned on the laser device platform. Each subject will be given a laser protective eye mask/goggles to wear and will be instructed how to wear the mask/goggles during the scan. In addition pulse monitor leads may be placed on the participant's chest to allow the computer to record ultrasound blood flow in the breast. The low intensity laser light will be focused on the targeted area of the breast.
16146664|NCT01807741|Drug|Asenapine|Available in 5 and 10 mg.
16146665|NCT01807741|Drug|Placebo|
16146666|NCT01807728|Other|Group 1 Training Program|Up to four group classes which will involve peer interaction, hands on training activities, and interaction with group leader(s).
16146667|NCT01807728|Other|Group 2 Training Program|Two group classes which will involve peer interaction, hands on training activities, and interaction with group leader(s).
16146668|NCT01807715|Other|survey|Survey before procedure to obtain demographic information and contraceptive information
16146669|NCT01807702|Drug|13C-Pyruvate 13C-lactate and dichloroacetate|Subjects will receive pyruvate and have blood,CO2, and buccal cell samples collected. The second visit the subjects will receive a dose of dichloroacetate before the pyruvate is given
16146670|NCT01807676|Device|ET View Double Lumen Tube|
16146671|NCT01807676|Device|conventional Double Lumen Tube|
16146672|NCT01807663|Device|healthy volonteers|Monitoring respiratory function of both acute and chronic neuromuscular patients during weaning or free breath period.
16146673|NCT01807663|Device|Free breath monitoring|Monitoring respiratory function of both acute and chronic neuromuscular patients during weaning or free breath period.
16146674|NCT01807650|Drug|Oleogel-S10, non-adhesive wound dressing|1 cm or 100 mg Oleogel-S10 per cm2 wound area (corresponds to thickness of approximately 1 mm or 0.04 inch) every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28
16146675|NCT01807650|Device|Non-adhesive wound dressing only|Soft silicone faced polyurethane foam dressing such as Mepilex® only every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28
16146676|NCT01807637|Device|transcranial direct current stim (tDCS)|During anodal tDCS, participants will receive 20 min at 2mA over motor cortex (with 30 seconds of ramp-up and ramp-down). During sham stimulation the stimulator is turned off.
16146677|NCT01807624|Drug|Tetracaine HCl 3% and Oxymetazoline HCl 0.05%|1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl (para-butylaminobenzoic acid or PABA is active metabolite)
16146689|NCT01807598|Drug|Brentuximab vedotin|
16146690|NCT01807585|Device|VenaSeal SCS|Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.
16146691|NCT01807585|Device|ClosureFast Radiofrequency Ablation (RFA)|Radiofrequency thermal ablation of the GSV using the Covidien ClosureFast system.
16146692|NCT01807585|Device|Roll-in (VenaSeal SCS)|Non-tumescent, non-thermal, non-sclerosant procedure that uses a proprietary medical adhesive delivered endovenously to close the vein.
16146693|NCT01807559|Device|SoundBite Hearing System|The Sonitus Medical SoundBite Hearing System prosthetic device is a bone conduction device that has been FDA cleared for the treatment of single-sided deafness (SSD) and conductive hearing loss (CHL). The Sonitus Medical SoundBite Hearing System consists of an In-the-Mouth (ITM) component, an external microphone component worn behind the ear (BTE), a calibration interface cable and PC-controlled software for subject calibration. A charger is also provided to charge the ITM and the BTE. The objective of this study is multi-site observational study is to asses the long-term patient use of the Sonitus Medical SoundBite Hearing System.
16146694|NCT01807546|Drug|rigosertib|Oral rigosertib capsules at a dose of 560 mg twice a day for 14 consecutive days of a 21-day cycle (2 weeks on, 1 week off regimen).
16146695|NCT01807533|Behavioral|Family-centered intervention program|This program was in-hospital intervention, after-discharge intervention, and neonatal follow-up. Five sessions of in-hospital intervention emphasized in the parental involvements with modulation of the NICU, a teaching of child developmental skills, feeding support, massage, interactional activities, child developmental skills, parent support and education, and transition home preparation. The 7-session after-discharge intervention consisted of 4 clinic visits and 3 home visits with specific care in modulation of home environment, teaching of child developmental skills, feeding support, teaching of interactional activities, and parent support and education
16146696|NCT01807533|Behavioral|Usual care intervention program|This program was in-hospital intervention, after-discharge consultation, and neonatal follow-up. Five sessions of in-hospital intervention emphasized in the parental involvements with modulation of the NICU, a teaching of child developmental skills, feeding support, massage, interactional activities, child developmental skills, parent support and education, and transition home preparation. The after-discharge service was provided 7-phone calls for the general health consultation.
16146697|NCT01807520|Biological|Secukinumab|Study treatment was provided in pre-filled 1 mL syringes.
16146698|NCT01807520|Biological|Placebo|Placebo was provided in pre-filled 1 mL syringes.
16146699|NCT01807507|Device|VeinViewer|VeinViewer® is designed to improve vascular access treatment standards and provide the highest possible quality in volunteer care. The device is a non-invasive handheld electronic visual aid device designed to project an image of superficial, subcutaneous vascular structures on the surface of the skin. VeinViewer's primary purpose is to assist in vascular visualization for IV starts and blood draws.
16146700|NCT01807494|Device|Total hip replacement components|All patients will receive the same implants
16146701|NCT01807481|Drug|Mircera|Once Monthly Mircera
16146702|NCT01807468|Procedure|haploidentical stem cell transplantation and NK cell therapy|
16146703|NCT01807455|Device|Restylane Vital Lidocaine|
16146704|NCT01807442|Other|Qualitative Interview and Adherence|All participants receive the same intervention. The intervention involves two qualitative interviews per participant. The first interview occurs in the hospital, and the second interview occurs at 12 weeks. Participants also receive a pill bottle that tracks when they take their aspirin. They will also receive a step counter to use for two weeks at the end of the study.
16146705|NCT01807429|Drug|Ketamine-midazolam|Ketamine 300-500mcg/kg plus midazolam 0.03 mg/kg once.
16146706|NCT01807429|Drug|Morphine|morphine 0.05 mg/kg
16146707|NCT01807416|Procedure|implant insertion and abutment connection|After implant insertion (standard platform or switching platform) the titanium abutment (standard or flat) will be connected
16146708|NCT01807403|Procedure|Deep brain stimulation|Pose of bilateral subthalamic and caudate stimulating macroelectrodes with subclavicular pacemaker.
16146709|NCT01807377|Drug|PF-05175157|200 mg tablet administered twice per day for 14 days
16146710|NCT01807377|Drug|Midazolam|2mg administered as single doses on Days 0 and 11
16146711|NCT01807377|Other|Placebo|Placebo administered twice per day for 14 days
16146712|NCT01807377|Drug|Midazolam|2mg administered as single doses on Days 0 and 11
16146713|NCT01807325|Procedure|pancreas biopsy|patients who are already having a pancreas biopsy will be invited to enroll. After obtaining enough tissue for usual medical care, we will divert some tissue for the study.
16146714|NCT01807312|Device|Endoscopic CO2 regulation unit and accessories|Olympus UCR Endoscopic CO2 Regulation Unit
16146715|NCT01807312|Device|Placebo|
16146716|NCT01807299|Dietary Supplement|Omega 3|Capsules of omega 3, 1000mg / capsules. Administered 3 times a day.
16146717|NCT01807299|Other|Physical Training|
16146718|NCT01807286|Drug|Pomalidomide|"Phase I: Starting dose of Pomalidomide 1 mg/day by mouth on days 1-21 of a 28 day cycle.
~Phase II: Starting dose of Pomalidomide maximum tolerated dose from Phase I."
16146719|NCT01807286|Drug|Melphalan|Phase I and II: 9 mg/m2 by mouth on days 1-4 of a 28-day cycle.
16146720|NCT01807286|Drug|Dexamethasone|Phase I and II: 40 mg/day by mouth on days 1-4 of a 28 day cycle.
16146721|NCT01807286|Behavioral|Questionnaires|Questionnaires about the feeling in hands and quality of life completed at different time points during the study.
16146722|NCT01807273|Other|Walking test|
16146723|NCT01807260|Procedure|Shock wave lithotripsy|All procedures were performed under continuous intravenous sedo-analgesia (using a combination of ketamine 1 mg/kg and propofol 0,5-1 mg/kg) with fluoroscopic or ultrasonograpic imaging in a supine position. Shock wave lithotrpisy was poerformed with a Dornier Compact Delta lithotripter (Dornier Medtech, Germany). Shock wave number was limited to a maximum of 3000 waves/session. In the conventional group the voltage was only 13 kV. The stone burden was defined as the stone area that was calculated by multiplying the largest length and width of the individual stones measured from the abdominal plain X-ray.
16146724|NCT01807247|Procedure|Intensive lower limbs muscles strengthening|
16146725|NCT01807234|Drug|Ketorolac|Single dose of Ketorolac (Sprix) nasal spray 31.5 mg, one spray in each nostril for an acute migraine attack.
16146726|NCT01807234|Drug|Sumatriptan|Sumatriptan (Imitrex) 20 mg one single dose of nasal spray for an acute migraine attack.
16146727|NCT01807234|Drug|Placebo|Placebo one spray in each nostril and placebo one nasal spray.
16146728|NCT01807221|Drug|Finerenone (BAY94-8862)|
16146729|NCT01807221|Drug|Placebo|
16146730|NCT01807221|Drug|Inspra (eplerenone)|
16146731|NCT01807208|Other|Educational Tool|"A personalized health goal education and reminder tool, with 3 parts: report card showing the status of secondary prevention domains during hospitalization; questions to help prepare the patient for the follow-up visit; and potential questions for the physician."
16146732|NCT01807195|Other|contrast medium usage|
16146733|NCT01807182|Biological|Aldesleukin|Given IV
16146734|NCT01807182|Drug|Cyclophosphamide|Given IV
16146735|NCT01807182|Drug|Fludarabine Phosphate|Given IV
16146736|NCT01807182|Other|Laboratory Biomarker Analysis|Correlative studies
16146737|NCT01807182|Biological|Therapeutic Tumor Infiltrating Lymphocytes|Undergo TIL infusion
16146738|NCT01807169|Procedure|Colonic polypectomy or endoscopic mucosal resection (EMR).|Resection of colonic polyps using polypectomy tehnique (with electrocoagulation) or mucosal resection (EMR or mucosectomy) with injection of physiological serum thus resection with electrocoagulation
16146739|NCT01807156|Drug|Tivozanib|Oral medication given daily. No placebo.
16146740|NCT01807143|Other|laboratory biomarker analysis|Correlative studies
16146741|NCT01807130|Other|Automated HF/EP Referral|Patients in the intervention arm without compelling contraindications to HF therapies will be referred automatically to specialists in HF or electrophysiology (EP) with recommendations to consider those therapies that are not in compliance with guidelines.
16146742|NCT01807130|Other|Placebo (Registry Arm)|Patients assigned to the registry will receive referral to specialists in HF or EP as deemed necessary by the patients physicians.
16146743|NCT01807117|Procedure|positron emission tomography|Undergo fludeoxyglucose F 18 PET-CT and PET-MRI
16146744|NCT01807117|Procedure|computed tomography|Undergo fludeoxyglucose F 18 PET-CT and PET-MRI
16146745|NCT01807117|Procedure|magnetic resonance imaging|Undergo fludeoxyglucose F 18 PET-CT and PET-MRI
16146746|NCT01807117|Radiation|fludeoxyglucose F 18|Undergo fludeoxyglucose F 18 PET-CT and PET-MRI
16146747|NCT01807104|Procedure|Anterior Approach / Posterior Approach|compare results of total hip arthroplasty performed through either an anterior or posterior surgical approach
16146749|NCT01807091|Drug|Chemotherapy|Receive outpatient induction chemotherapy
16146751|NCT01807078|Dietary Supplement|Nutraceuticals|1 capsule/day containing monacolin K 10 mg, policosanol 10 mg, and phytosterols 300 mg
16146752|NCT01807065|Biological|sipuleucel-T|Given IV
16146753|NCT01807065|Radiation|external beam radiation therapy|Undergo external beam radiation therapy
16146754|NCT01807065|Other|laboratory biomarker analysis|Correlative studies
16146755|NCT01807052|Other|laboratory biomarker analysis|Correlative studies
16146756|NCT01807039|Procedure|hip fracture surgery|we evaluate the relationship between the monitored parameters and 30 day survival
16146757|NCT01807026|Drug|LY2886721|
16146758|NCT01807026|Drug|Placebo|
16146759|NCT01807013|Procedure|ultrasound, liver elastometry, minilaparoscopy|"conventional high-end ultrasound technique,
~small access laparoscopy with fine laparoscopes
~Acoustic radiation force impulse (ARFI): ARFI technology uses short-duration acoustic radiation forces (approximately 100 microseconds) to generate a localized tissue displacement which results in a lateral shear-wave propagation. ARFI shear wave velocity (SWV) measured in m/sec tracked with ultrasonic correlation-based methods is proportional to the square root of tissue elasticity."
16146760|NCT01807000|Drug|Radiolabeled Prucalopride Succinate|A single oral dose of 2 mg radiolabeled prucalopride succinate administered on Day 1.
16146761|NCT01806987|Behavioral|KITS Program|The KITS Program is a 4-month psychosocial intervention for children at high risk for school difficulties and their caregivers. The intervention begins in the summer before kindergarten and continues across the first two months of kindergarten. The KITS intervention consists of: (a) child school readiness play groups to facilitate the development of self-regulatory, social, and early literacy skills (2 times per week in summer, 1 time per week in the fall); and (b) a 12 session psychoeducational workshop to promote parent involvement in the child's early literacy and schooling and the use of effective parenting techniques (once per week in summer, bi-weekly in the fall).
16146762|NCT01806974|Other|oral exam and|The study will be conducted with patient presenting a rheumatoid arthritis and for which an anti IL6 biotherapy treatment is planned. Each patient will benefit a record oral exam that will evaluate his periodontal status and on a possible periodontitis associated. Bacterial samples and cytokine will be realized (in defined periodontal pocket or in the most affected periodontal pocket depending of the periodontal status of patients) before the IL6 biotherapy and 6 month after. A periodontal charting will be realized at the same time.
16146763|NCT01806948|Drug|Ramosetron|
16146764|NCT01806935|Device|DC086|
16146765|NCT01806935|Device|Placebo|
16146766|NCT01806922|Behavioral|Yoga|
16146767|NCT01806909|Biological|Ad4-H5-Vtn|
16146768|NCT01806896|Drug|PF-02545920|"Dose will be titrated up every 2 days by 5mg increments: 5mg Days 1-2, 10mg days 3-4, 15mg days 5-6, and reach 20 mg from Days 7 to Day28.
~Orally, approx. Q12H (range 10-14 hours), administered at least one hour prior to, or two hours after meals.
~Treatment for 28 days."
16146769|NCT01806896|Drug|Placebo|"- Orally, approx. Q12H (range 10-14 hours), administered at least one hour prior to, or two hours after meals.
~Dosing for 28 days."
16146770|NCT01806896|Drug|PF-02545920|"5mg dose
~Orally, approx. Q12H (range 10-14 hours), administered at least one hour prior to, or two hours after meals.
~Dosing for 28 days."
16146771|NCT01806896|Drug|Placebo|"Orally, approx. Q12H (range 10-14 hours), administered at least one hour prior to, or two hours after meals.
~Dosing for 28 days."
16146772|NCT01806883|Behavioral|WII Rehabilitation|"30 patients will receive Wii rehabilitation of 15 minutes (tennis, boxing and golf), in comparison with 10 healthy subjects."
16146773|NCT01806883|Behavioral|Traditional rehabilitation|30 patients will receive the traditional rehabilitation.
16146774|NCT01806870|Dietary Supplement|Zinc and SAMe|If a subject has side effects their dose of Zinc will be reduced. SAMe will remain the same dose.
16146775|NCT01806857|Drug|Nuedexta|Nuedexta PO (by mouth) for 28 ± 3 days
16146776|NCT01806857|Drug|Matching Placebo|matching placebo PO (by mouth) for 28 ± 3 days
16146777|NCT01806831|Device|"Biocellulose Mask, Farhorm®"|
16146778|NCT01806818|Drug|Epirisone 50mg or placebo TID|3 times a day after meals for 1 week
16146779|NCT01806805|Drug|zonegran|
16146780|NCT01806805|Drug|placebo|
16146781|NCT01806792|Drug|risedronate combine|
16146782|NCT01806792|Drug|Risedronate|
16146783|NCT01806792|Drug|Placebo(for Risedronate)|
16146784|NCT01806792|Drug|Placebo(for risedronate combine)|
16146785|NCT01806779|Drug|Chantix|
16146786|NCT01806779|Drug|Zyban|
16146787|NCT01806779|Drug|Nicotine patches|All participants will receive 21 mg/24 h dose nicotine (nic.) patches for 1 week.
16146788|NCT01806766|Procedure|Ceramic on Ceramic bearing|cementless Total Hip Arthroplasty with Ceramic on ceramic bearing
16146789|NCT01806766|Procedure|Ceramic on Highly crosslinked polyethylene bearing|Cementless Total Hip Arthroplasty with Ceramic on Highly crosslinked polyethylene bearing
16146790|NCT01806753|Procedure|Intermittent midazolam/propofol injection controlled by endoscopist|"In this arm1, sedation during endoscopic submucosal dissection is controlled by endoscopists.
~First, pethidine 50 mg with midazolam 0.05 mg/kg are injected in a bolus fashion.
~When the patient seems to be discomfort or the patient's movements were observed, endoscopists should check the Modified Observer Assessment of Alertness/Sedation (MOAAS).
~If MOAAS is 5 or 6, propofol 0.25 mg/kg will be injected. Otherwise, pethidine 12.5 mg will be injected."
16146791|NCT01806753|Procedure|Continuous propofol infusion with opioid administration|"In this arm2, sedation during endoscopic submucosal dissection is controlled by anesthesiologists.
~First, remifentanil 0.5 ug/kg with propofol 0.5 mg/kg are injected in a bolus fashion.
~Then, remifentanil 0.08 ug/kg/min and propofol 2 mg/kg/h are infused continuously.
~When the patient seems to be discomfort or the patient's movements were observed, anesthesiologists should check the MOAAS.
~If MOAAS is 5 or 6, infusion rate of propofol will be increased by 0.5 mg/kg/h. Otherwise, infusion rate of remifentanil will be increased by 0.02 ug/kg/min."
16146792|NCT01806740|Drug|Gadoterate meglumine|Gadoterate meglumine was administered at a dose of 0.1 mmol/kg (0.2 mL/kg) using a power injector, in an intravenous bolus at a rate of 3 mL/sec.
16146793|NCT01806727|Behavioral|Community Lifestyle Weight Loss (LWL)|Changing dietary and physical activity behavior to promote weight loss
16146794|NCT01806727|Behavioral|Diabetes Self Management (DSM)|Changing diet, physical activity, self monitoring, and medication related behaviors to improve diabetes control
16146795|NCT01806714|Other|Text-based reminder for recommended HPV vaccine or WCC|Patients due for a well visit or HPV vaccine received a text reminder
16146796|NCT01806714|Other|Non-specific text-based reminder (general health tip)|Parents of adolescents receive preventive health tips via text messages (not specific to services for which child is due)
16146797|NCT01806701|Behavioral|Trauma-focused cognitive behavioral therapy|the 'gold-standard' behavioral treatment for children/adolescents with posttraumatic stress disorder
16146798|NCT01806688|Other|gluten-free high protein snack #1|buckwheat groats 30g serving
16146799|NCT01806688|Other|gluten-free snack with similar energy density but 1/2 the protein as snack #1|32g serving of corn nuts
16146800|NCT01806688|Other|non-caloric control|water
16146801|NCT01806688|Other|gluten-free high protein and high fibre snack #2|buckwheat and pinto bean flour pita bread 50g serving
16146802|NCT01806688|Other|gluten-free snack with similar energy density, but less protein and fibre than snack #2|50g serving of rice bread
16146803|NCT01806675|Drug|18F-fludeoxyglucose (18F-FDG)|18F-FDG will be used as the radiotracer for a regular medical care PET/CT or PET/MRI scan
16146804|NCT01806675|Drug|18F-FPPRGD2|18F-FPPRGD2 will be used as the radiotracer for a PET/CT or PET/MRI scan. Participants will be injected with less than 10 mCi of 18F-FPPRGD2.
16146805|NCT01806662|Drug|Ustekinumab|Injection of monoclonal antibody against the p40 subunit of IL-12/23
16146806|NCT01806662|Other|Placebo|Injection of placebo
16146807|NCT01806649|Drug|BKM120|
16146808|NCT01806636|Device|PneumRx Coil System|
16146809|NCT01806623|Drug|Fluconazole|Single oral dose of 150mg Fluconazole
16146810|NCT01806610|Drug|BPS804|Single dose BPS804 administration.
16146811|NCT01806610|Drug|Placebo|Single dose placebo administration.
16146812|NCT01806597|Biological|secukinumab 150 mg|Study treatment were provided in pre-filled syringes of secukinumab 150 mg in 1 mL. Each dosing consiseds of one secukinumab 150 mg s.c. injection plus one placebo secukinumab s.c. injection and took place once weekly during five weeks (at Baseline, Weeks 1, 2, 3 and 4), then once every four weeks starting at Week 8 until Week 128 inclusive. In order to maintain the blinding, patients also received two placebo injections at Weeks 17, 18 and 19. Patients self-administered study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise.
16146813|NCT01806597|Biological|secukinumab 300 mg|Study treatment were provided in pre-filled syringes of secukinumab 150 mg in 1 mL. Each dosing consisted of two secukinumab 150 mg s.c. injections and took ke place once weekly during five weeks (at Baseline, Weeks 1, 2, 3 and 4), then once every four weeks starting at Week 8 until Week 128 inclusive. In order to maintain the blinding, patients also receives two placebo injections at Weeks 17, 18 and 19. Patients self-administered study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise.
16146814|NCT01806597|Biological|Placebo|Placebo were provided in 1 mL pre-filled syringes. Each dosing consisted of two s.c. injections and took place once weekly during five weeks (at Baseline, Weeks 1, 2, 3 and 4), then at Week 8 and at Week 12. At Week 16, ppIGA responders continued on placebo with dosing at Weeks 16, 17, 18, 19 and 20, then once every four weeks from Week 24 until Week 76 inclusive. At Week 80, ppIGA responders ended their participation in the study while ppIGA non-responders were re-randomized, to receive 150 mg or 300 mg secukinumab once every four weeks starting at Week 80 until Week 128 inclusive. Patients self-administered study treatment under the supervision of site personnel when injections occur during study visits, or at home otherwise.
16146815|NCT01806584|Biological|SRM003|One time implant (3 SRM003 pieces) on surgery day.
16146816|NCT01806584|Other|Participating Site's standard practice|Subjects will receive sites' standard practice treatment during the surgical procedure
16146817|NCT01806571|Drug|Cytarabine|Given IV
16146818|NCT01806571|Drug|Daunorubicin Hydrochloride|Given IV
16146819|NCT01806571|Other|Laboratory Biomarker Analysis|Correlative studies
16146820|NCT01806571|Drug|Nilotinib|Given PO
16146821|NCT01806571|Other|Pharmacological Study|Correlative studies
16146822|NCT01806558|Procedure|Molecular Breast Imaging|Molecular breast Imaging is a new nuclear medicine technique for imaging the breast. It uses small filed of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.
16146823|NCT01806545|Biological|SRM003|One time implant (2 SRM003 pieces) on surgery day.
16146824|NCT01806545|Other|Participating Site's standard practice|Subjects will receive sites' standard practice treatment during the surgical procedure.
16146825|NCT01806519|Behavioral|Motor control intervention of head posture|"The tailored motor control intervention used for motor learning-procedure described by Fitts and Posner, further developed and adapted to rehabilitation of the spine by O´Sullivan.
~The stages involved in the process was the Cognitive stage, Associative stage and the Autonomous stage"
16146826|NCT01806506|Procedure|Laparoscopic sleeve gastrectomy|Laparoscopic sleeve gastrectomy (LSG) is a restrictive bariatric procedure. LSG involves resection of a large part of the body and fundus of the stomach starting from the antrum up to the angle of His. The remaining part of the stomach (the gastric sleeve) is calibrated with a 36 French bougie.
16146827|NCT01806506|Procedure|Roux-en-Y Gastric Bypass|Roux-en-Y gastric bypass (RYGB) is an intermediate (restrictive and malabsorptive) operation. RYGB involves creation of a 15-20 mL gastric pouch that is anastomosed to a 100cm Roux limb created at 100cm from the ligament of Treitz.
16146828|NCT01806480|Behavioral|Person-centred proactive breastfeeding telephone support|Person-centred care is a model of care, which comprise components such as: building mutual trust and understanding; treating the person as an individual; respect the rights for the person, sharing decision-making, providing holistic care and developing therapeutic relationships. Furthermore, the care provider should have a sympathetic presence and show an engagement
16146829|NCT01806454|Drug|calcium|
16146830|NCT01806441|Other|3-days high fat diet|During 3 days, subjects eat a diet high in fat (percent of total caloric intake: 15.0% from proteins; 49,8% from carbohydrates; 37.0% from fat).
16146831|NCT01806441|Other|3-days low fat diet|During 3 days, subjects eat a diet low in fat (percent of caloric intake: 15.0% from proteins; 61,8% from carbohydrates; 25.0% from fats).
16146832|NCT01806415|Drug|Fenobam|Oral administration of 50, 100, or 150mg of Fenobam or placebo (lactose)
16146833|NCT01806415|Drug|Placebo|Oral administration of placebo or lactose 150 mg
16146834|NCT01806376|Drug|Subutinib Maleate capsules|Dose escalation will be dependent on any dose limiting toxicities
16146835|NCT01806363|Drug|Telmisartan 80mg|
16146836|NCT01806363|Drug|Chlorthalidone 25mg|
16146837|NCT01806350|Other|questionnaire administration|Ancillary studies
16146838|NCT01806350|Procedure|standard follow-up care|Receive usual care
16146839|NCT01806350|Other|educational intervention|Undergo PFMT
16146840|NCT01806337|Drug|Alemtuzumab|Consolidation after CHOP induction
16146841|NCT01806324|Drug|HL040XC|single dose
16146842|NCT01806324|Drug|Losartan + Atorvastatin|Single dose
16146843|NCT01806311|Drug|Candesartan32mg|
16146844|NCT01806311|Drug|Amlodipine10mg|
16146845|NCT01806298|Drug|Saizen® solution for injection (referred as Saizen®)|Saizen® solution for injection will be administered subcutaneously daily for 39 weeks according to locally approved product labeling for the currently marketed formulation of Saizen®.
16146846|NCT01806272|Drug|rhGM-CSF|The rhGM-CSF is prepared as a mouthwash solution,diluting 150μg in 100ml water(final concentration of 1.5μg/ml).Patient is instructed to use the solution five times daily.
16146847|NCT01806272|Drug|Compound Vitamin B12|Compound Vitamin B12 solution 5ml being sprayed to mouth five times daily
16146848|NCT01806259|Drug|Ketorolac 30 mg IV|Active drug
16146849|NCT01806259|Drug|Placebos|Placebo looking like the Active drug
16146850|NCT01806246|Behavioral|integrative rehabilitation program|
16146851|NCT01806233|Procedure|Acupuncture|The treatment group：60 patients receive Acupuncture ，selecting acupoint on:Shenting（DU24), Baihui（DU20）, Fengchi（GB20), Hanyan（GB4）, Jianyu（LI15）, Quchi（LI11）,Waiguan（SJ5）, Zusanli（ST36）, Fenglong（ST40）, Xingjian(LV2), Yongquan（KI1）, 20minutes each time，ten times / treatment course，two treatment courses in total.
16146852|NCT01806233|Procedure|Rehabilitation|The matched group：60 patients receive rehabilitation treatment，45 minutes each once，ten time as a period of treatment，two periods of treatment in all.
16146853|NCT01806220|Procedure|Biopsy of the retrocrycoid laryngeal mucosa|Biopsies of the retrocrycoid laryngeal mucosa were performeed under sedation using a forceps introduced by the working channel of the endoscope
16146854|NCT01806220|Procedure|Biopsy of the distal esophageal mucosa|Biopsies were performeed under sedation using a forceps introduced by the working channel of the endoscope during upper digestive endoscopy
16146855|NCT01806207|Device|Durolane injection|
16146856|NCT01806207|Other|Saline injection|
16146857|NCT01806194|Behavioral|Lifestyle Counseling|Small changes behavioral counseling and social support, delivered in 16 sessions by community health workers
16146858|NCT01806194|Behavioral|Educational Control Arm|16 mailings of diabetes educational materials but no regular contact with community health workers
16146859|NCT01806181|Other|Exercise|
16146860|NCT01806168|Device|rTMS|Magstim Super Rapid-2
16146861|NCT01806142|Other|Medium-chain triglycerides|During Medium-Chain Triglycerides (MCT period), participant will asked to consume two pastries per day that will provide a total of 20 g of MCT/day for 4 weeks.
16146862|NCT01806142|Other|Corn oil|During Corn oil period (Control period), participant will asked to consume two pastries per day that will provide a total of 20 g of corn oil/day for 4 weeks.
16146866|NCT01806116|Drug|decitabine|
16146867|NCT01806103|Behavioral|Antimicrobial Stewardship Bundle|Guidelines, Education, Audit and Feedback
16146868|NCT01806090|Drug|clopidogrel|Clopidogrel 7 days prior to the endoscopic procedure (Colonoscopy)
16146869|NCT01806090|Other|Placebo|Placebo for 7 days prior to the endoscopic procedure (Colonoscopy)
16146870|NCT01806077|Drug|PZ-128|Sequential single-dose escalation; 1 to 2 hour continuous intravenous infusion
16146871|NCT01806064|Drug|TRC105 and Axitinib|
16146872|NCT01806064|Drug|Axitinib|
16146873|NCT01806051|Drug|Kuvan|Only PKU participants (Arm 1) will be administered Kuvan once daily either at a dose of 20 mg/kg/day (if the PKU participant is not currently taking Kuvan) or at the subject's regular dose (if the PKU participant is currently taking Kuvan). They will remain on Kuvan for 4 weeks.
16146874|NCT01806038|Other|RPh Counseling + Outpatient Med Dispensing at Discharge|On the day of discharge, a pharmacist will perform a chart review and medication reconciliation on all patients' discharge medications (for patients randomized to the intervention arm). Any medication discrepancies will be addressed with the patient's primary care team. At the time of discharge, the patient will receive his/her discharge medications dispensed from the Duke Outpatient Pharmacy, along with medication counseling by a licensed pharmacist
16146875|NCT01806038|Other|Discharge Med Dispensing Plus Counseling - Current Practice|At hospital discharge, patients will receive standard discharge procedures and obtain discharge medications per their usual process
16146876|NCT01806025|Other|no intervention|
16146877|NCT01806012|Device|Sealing tissue with the Enseal device|
16146878|NCT01806012|Procedure|Conventional supracervical hysterectomy|
16146879|NCT01805999|Dietary Supplement|7 g Ispaghula|
16146880|NCT01805999|Dietary Supplement|7 g placebo|
16146881|NCT01805999|Dietary Supplement|3.5g Ispaghula + 3.5 g placebo|
16146882|NCT01805973|Behavioral|Exercise Training|Patients will participate in a supervised exercise training programme for 18 weeks. Patients will participate in a 50 minute exercise regime three times a week.
16146883|NCT01805960|Biological|Canakinumab|
16146884|NCT01805960|Biological|Placebo|
16146885|NCT01805947|Behavioral|Lifestyle Modification|Lifestyle Modification
16146886|NCT01805934|Drug|RBLF|The patients in Group RBLF will receive a 14-day quadruple therapy,including rabeprazole(10mg bid),bismuth citrate(220mg bid),levofloxacin(200mg qm) and furazolidone(100mg bid).
16146887|NCT01805934|Drug|RA|The patients in Group RA will be sent to a penicillin skin test before treatment except they were given penicillin before. They will receive a 14-day dual therapy with high doses of rabeprazole(20mg bid) and amoxicillin(1000mg tid).
16146888|NCT01805921|Biological|PanAd3-RSV given intra-nasally (high dose)|High dose = 5x10^10 vp
16146889|NCT01805921|Biological|MVA-RSV given by intra-muscular injection (high dose)|High dose = 1x10^8 pfu
16146890|NCT01805921|Biological|PanAd3-RSV given by intra-muscular injection (high dose)|High dose = 5x10^10 vp
16146891|NCT01805921|Biological|PanAd3-RSV given intranasally (low dose)|Low dose = 5x10^9 vp
16146892|NCT01805921|Biological|MVA-RSV given by intra-muscular injection (low dose)|Low dose = 1x10^7 pfu
16146893|NCT01805921|Biological|PanAd3-RSV given by intra-muscular injection (low dose)|Low dose = 5x10^9 vp
16146894|NCT01805908|Other|111In-Pertuzumab + SPECT-CT|111In-PmAb will be provided ready for injection in a vial by Dr. Reilly's laboratory.
16146895|NCT01805895|Drug|Minocycline|This arm will receive a total of 5 doses of minocycline. Dose 1 will be 400mg IV within 12-hours of onset of symptoms. Dose 2 will be 400mg oral, given daily on days 2-5 . Each dose is 24 hours apart.
16146896|NCT01805882|Drug|Sofosbuvir|
16146897|NCT01805882|Drug|Ledipasvir|
16146898|NCT01805882|Drug|GS-9669|
16146899|NCT01805882|Drug|GS-9451|
16146900|NCT01805856|Drug|PIPC piperacillin sodium|
16146901|NCT01805856|Drug|CEZ, cefazolin sodium|
16146902|NCT01805843|Other|Echo, exercise echo, and if indicated, right heart catheter|routine echocardiography and special measurements of the right heart are performed at rest and during exercise
16146903|NCT01805830|Drug|MP513|form : Pink film-coated tablet for oral administration Dosage : 20mg/tablet frequency and duration: 1 tablet/day
16146904|NCT01805830|Drug|Placebo|form : Pink film-coated tablet for oral administration Dosage : 20mg/tablet frequency and duration: 1 tablet/day
16146905|NCT01805817|Drug|YASMIN® (Drospirenone/Ethinyl Estradiol)|oral contraceptive pills
16146906|NCT01805817|Device|The Copper-T is an intrauterine device (IUD)|intrauterine device for contraception
16146907|NCT01805817|Device|levonorgestrel-releasing system|intrauterine device
16146908|NCT01805804|Drug|placebo/valsartan|
16146909|NCT01805791|Drug|HMPL-004 1800 mg/day|Subjects randomized to the arm of HMPL-004 1800 mg/day will receive HMPL-004 600 mg TID (total dose 1800 mg/day) for 56 days (8 weeks).
16146910|NCT01805791|Drug|Placebo|Subjects randomized to the arm of Placebo will receive matching Placebo three times daily for 56 days (8 weeks).
16146911|NCT01805791|Drug|HMPL-004 2400 mg/day|Subjects randomized to the arm of HMPL-004 2400 mg/day will receive HMPL-004 800 mg TID (total dose 2400 mg/day) for 56 days (8 weeks).
16146912|NCT01805765|Drug|Qing'E pills|composed of eucommia, psoralen, walnuts and garlic
16146913|NCT01805765|Drug|Placebo|Containing 2% of Qing'E pills
16146914|NCT01805752|Other|Task-shifting to lower-cadre providers at PMTCT sites|
16146915|NCT01805752|Other|POC CD4+ cell count testing|
16146916|NCT01805752|Other|integrated mother-infant care|
16146917|NCT01805752|Other|Prominent role for influential family members (male partners) in collaboration with CHWs|
16146918|NCT01805726|Drug|xylocain|Xylocain: (C): Local anesthesia 1% 25 ml in total (bronchoscopy) + saline serum
16146919|NCT01805726|Drug|Alfentanil|(A) Local anesthesia 1% 25 ml in total (bronchoscopy) + saline serum (slow perfusion for 10 minutes) + alfentanil 10 mcg / kg (slow injection in 5 seconds)
16146920|NCT01805726|Drug|Dexmedetomidine|(D) Local anesthesia 1% 25 ml in total (bronchoscopy) + dexmedetomidine 0.5 mcg / kg (slow perfusion for 10 minutes) + 2 ml saline (slow injection for 5 seconds)
16146921|NCT01805700|Other|Caffeine enhanced energy drink|Comparison of different energy drinks
16146922|NCT01805700|Other|Glucose drink|Glucose drink (containing 84mg glucose alone)
16146923|NCT01805687|Drug|Zileuton extended release|
16146924|NCT01805674|Dietary Supplement|isoflavones combined with magnolia|1 tablet/day duration: 12 weeks
16146925|NCT01805661|Procedure|Canal Block and Capsular Injection|Continuous Adductor canal block with 15-30ml of ropivacaine 0.1% with epinephrine 1:400,000 followed by an infusion of ropivacaine 0.1% at 6 ml per hour for 2 days post operatively. This is combined with ultrasound guided posterior capsular knee injection with 30 ml ropivacaine 0.1% with epinephrine 1:400,000.
16146926|NCT01805661|Procedure|Femoral with Tibial Nerve Block|Continuous femoral nerve block with 15 ml of ropivacaine 0.1% followed by an infusion of ropivacaine 0.1% at 6 ml per hour for 2 days after surgery combined with tibial nerve block in the popliteal fossa with ropivacaine 0.1% up to 15 ml.
16146927|NCT01805648|Drug|rhTPO|Subcutaneously dosing of rhTPO is based on screening weight. Subjects will be given rhTPO 300 IU/Kg once daily up to 14 days in the pre-treatment period . When two consecutive platelet counts is above 50×10^9/L, the subjects will be begin to receive maintenance treatment of rhTPO 300 IU/Kg. In the period of maintenance treatment, starting dosing interval of rhTPO is every other day followed by the interval adjustments for keeping platelet counts between 30×10^9/L～100×10^9/L.
16146928|NCT01805635|Other|No intervention|No intervention
16146929|NCT01805622|Behavioral|Active Arm #1, #2, Passive Arm #1, #2|This four-arm cluster randomized trial (five community coalitions plus 1,800 African Americans, 50-74 years of age, who are not current on CRC screening per arm) compares the following implementation strategies: (1) web access to facilitator training materials and toolkits without technical assistance (TA); (2) web access, but with technical assistance (TA); (3) in-person access to facilitator training materials and toolkits without TA and (4) in-person access with TA.
16146930|NCT01805609|Behavioral|Working with the Caregiving Family (WCF) training|Training curriculum will be comprised of 2 phases to be attended sequentially: (l) The Didactic Phase will consist of 6 twice a month seminars, administered over a 3 month period. Each seminar includes a 1 hour lecture & discussion followed by 1 hour of role-play exercises; Lecture segments may include short training videos which Dr. Zaider uses in the nurses' training module she teaches through the Communication Skills Laboratory. The teaching portion of the didactic sessions of the training may also be videotaped as a reference point for curriculum review. Will explain to the providers that videotapes will only be available to study staff & that the role play portion will not be recorded; (2) Consolidation Phase will consist of 6 twice a month peer-group supervision meetings for ongoing consultation on family cases, also held across a 3 month period. Length of these consolidations sessions will be up to 2 hours.
16146931|NCT01805609|Behavioral|questionnaires|
16146932|NCT01805596|Drug|clopidogrel|
16146933|NCT01805596|Drug|Ticagrelor|
16146934|NCT01805583|Other|Acceptance and Commitment Therapy (ACT)|
16146935|NCT01805583|Other|workplace intervention (WPI)|
16146936|NCT01805570|Drug|Prasugrel|25 patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed) will be randomized to receive Prasugrel before PPCI. The loading dose of Prasugrel will be 60 mg. The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered .
16146937|NCT01805570|Drug|Ticagrelor|25 patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed) will be randomized to receive Ticagrelor before PPCI. The loading dose of Ticagrelor will be 360 mg. The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In the case of vomit in the first hour after drug loading dose a new reduced loading dose will be administered .
16146938|NCT01805557|Drug|R-DHAP|"Rituximab 375 mg/sqm iv day 0 or 1
~Cisplatin 100 mg/sqm iv day 1 in 6-hours infusion
~Cytarabine 2000 mg/sqm in 3-hours infusion iv day 2 and day 3
~Dexamethasone 40 mg day 1-4
~Pegfilgrastim 6 mg sc monodose 24 hours after the end of chemotherapy or G-CSF from day 5 till stem cell harvest during mobilization's course (II o III cycle R-DHAP)
~Rituximab 375 mg/sqm iv 24 hours before apheresis as purging in vivo during second courses of therapy"
16146939|NCT01805557|Drug|BR-DHAP|"Rituximab 375 mg/sqm iv day 0 or 1
~Bortezomib SC 1.5 mg/sqm day 1, day 4
~Cisplatin 100 mg/sqm iv day 1 in 6-hours infusion
~Cytarabine 2000 mg/sqm in 3-hours infusion iv day 2 and day 3
~Dexamethasone 40 mg day 1-4
~Pegfilgrastim 6 mg sc monodose 24 hours after the end of chemotherapy or G-CSF from day 5 till stem cell harvest during mobilization's course (II o III cycle R-DHAP)
~Rituximab 375 mg/sqm iv 24 hours before apheresis as purging in vivo during second courses of therapy Chemotherapy R-DHAP and BR-DHAP will be repeated every 28 days."
16146940|NCT01805544|Drug|Rivaroxaban (Xarelto, BAY59-7939)|20 mg po once daily, which is also the recommended maximum dose. SmPC recommendations are to be followed for renal impairment
16146941|NCT01805531|Drug|Rivaroxaban (Xarelto, BAY59-7939)|20 mg po once daily, which is also the recommended maximum dose. In subjects with moderate creatinine clearance (30-49 ml/min), the dose 15 mg once daily is recommended.
16146942|NCT01805518|Dietary Supplement|Scelectium Tortuosum|"One arm has subjects 3 weeks on Scelectium Tortuosum 25gm po/d then 3 weeks off and then 3 weeks on Placebo.
~The other arm has subjects 3 weeks on placebo, then 3 weeks off and then 3 weeks on Scelectium Tortuosum 25mg po/d."
16146943|NCT01805505|Procedure|Transvaginal ultrasound-guided embryo transfer|Embryo transfer of two day-3 embryos performed with the Kitazato Long ET catheter (Kitazato Medical Co. Ltd., Tokyo, Japan), guided by transvaginal ultrasound
16146944|NCT01805505|Procedure|Transabdominal ultrasound-guided embryo transfer|Embryo transfer of two day-3 embryos performed with the Cook Soft-Trans ET catheter (Cook Medical Inc., Bloomington, IN, USA), guided by transabdominal ultrasound
16146945|NCT01805492|Behavioral|Dr. Dean Ornish Program for Reversing Heart Disease|Prospective, nonrandomized clinical intervention to stabilize or reverse progression of heart disease through changes in lifestyle. Lifestyle intervention consisted of four components: 1) a very low fat vegetarian diet (<10% of calories from fat); 2) 180 minutes/week of moderate aerobic exercise; 3) one hour of stress management each day; and 4) weekly group support sessions.
16146946|NCT01805479|Other|aerobic exercise|the active arm will be asked to perform 60% of maximum heart rate
16146947|NCT01805479|Other|stretching and flexibility program|stretching and flexibility program for the Placebo Comparator Arm
16146948|NCT01805466|Device|EVADO|EVADO (Extracorporeal Vacuum-Assisted Device Optimized) device enables separation of cardiotomy suction blood, which is stored in a separate reservoir, and, if re-infusion into the CPB circuit is required, this is performed only after selective filtering and by cell saver procedures. Moreover, by using a vacuum-assisted system for blood aspiration, EVADO allows complete elimination of roller pumps, therefore reducing the extent of mechanical cellular trauma. EVADO contains a phosphorylcholine-coated oxygenator, that confers superior biocompatibility. Finally, by requiring relatively limited priming volumes, it allows reducing haemodilution.
16146949|NCT01805466|Device|Conventional CPB|conventional miniature cardiopulmonary bypass technique
16146950|NCT01805453|Drug|Losartan|Standard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide ) + Losartan or placebo (Arm A or B) 50mg*2/day until the halting for any reason
16146951|NCT01805453|Drug|Placebo|Standard of care (Radiotherapy with concomitant temozolomide followed by monthly cures of temozolomide + Placebo 2/day until the halting for any reason
16146952|NCT01805440|Drug|Uridine|Uridine is the active treatment in this clinical trial.
16146953|NCT01805440|Drug|Placebo|Pill placebo is the inactive treatment comparator in this clinical trial.
16146954|NCT01805414|Other|Modified Carbohydrate Breakfast|
16146955|NCT01805414|Other|Control Breakfast|
16146956|NCT01805401|Device|Transcranial Direct Current Stimulation|Anode placed over the OFC or the DLPFC and cathode placed over the occipital region
16146957|NCT01805388|Drug|Experimental: Regeneration Treatment Group|Regenerative Root Canal Therapy using Triple Antibiotic Paste study drug
16146958|NCT01805388|Procedure|Control Non-Study Drug Group|Endodontic RTC with no study drug
16146959|NCT01805375|Drug|DI-B4|DI-B4 will be administered once weekly for up to a total of four weeks. The starting dose will be 0.02 mg given as an intravenous infusion. A cycle is 1 week in duration and patients should expect to receive a maximum of 4 cycles.
16146960|NCT01805362|Other|Randomization that determine the time of treatment|
16146961|NCT01805349|Radiation|Hand X-rays|Hand X-rays to assess the digital arthrosis
16146962|NCT01805336|Other|Assessment of attentional functions by traditional tests|For assessment of attentional functions, traditional tests include : Symbol Digit Modalities Test (SDMT), Test d'Evaluation de l'Attention (TEA), Attentional Network Test (ANT).
16146963|NCT01805336|Other|Assessment of attentional functions by virtual reality tests|For assessment of attentional functions, virtual reality tests include : Monotonous task of driving on motorways, Task of city driving with accident scenarios, Monotonous driving task with divided attention test ; all tests realized on a driving simulator.
16146964|NCT01805336|Other|Assessment of executive functions by traditional tests|For assessment of executive functions, traditional tests include : Wisconsin Card Sorting Test (WCST), Task verbal fluencies, Sequence Numbers Letters subtest of the Wechsler Adult Intelligence Scale (WAIS) III, Commissions.
16146965|NCT01805336|Other|Assessment of executive functions by virtual reality test|For assessment of executive functions, virtual reality test include : VAP-S.
16147253|NCT01803074|Drug|Ritonavir|Ritonavir
16146966|NCT01805336|Other|Evaluation of cognitive complaint, fatigue, anxiety and depression|The following questionnaires will be completed by the participant at the inclusion visit : cognitive complaint RBN-SEP questionnaire to assess cognitive complaint, EMIF-SEP to assess fatigue, STAI (State Trait Anxiety Inventory) to assess anxiety and MADRS to assess depression.
16146967|NCT01805323|Drug|Dexamethasone Intravitreal Implant|Dexamethasone Intravitreal Implant (OZURDEX®) previously administered according to general clinical practice.
16146968|NCT01805310|Other|Bowel preparation|Subjects randomized to the mechanical bowel preparation arm will be instructed to consume 300cc of magnesium citrate no later than 3PM on preoperative day number one.
16146969|NCT01805310|Other|No bowel preparation|Subjects randomized to no bowel preparation will be instructed to continue a regular diet on preoperative day number one.
16146970|NCT01805297|Drug|Intravitreal Aflibercept Injection|One time 2.0mg aflibercept injection, following pars plana vitrectomy.
16146971|NCT01805297|Other|Standard Vitrectomy|Surgical intervention
16146972|NCT01805284|Drug|Linezolid|600 mg linezolid as a 1 hour controlled infusion (acceptable time frame is between 30 and 120 minutes), twice, at least 3 days.
16146973|NCT01805271|Drug|Everolimus|(5 or 10mg/day, i.e. 1 or 2 tablets/day)
16146974|NCT01805271|Drug|Placebo|
16146975|NCT01805258|Drug|Nevirapine|The regimen containing Nevirapine: 3TC/ZDV 150/300 mg 1 tablet BID + NEVIRAPINE 200 mg qD for 2 weeks then 200mg BID
16146976|NCT01805258|Drug|Efavirenz|The regimen containing Efavirenz: 3TC/ZDV 150/300 mg 1 tablet BID + EFAVIRENZ 600 mg qD
16146977|NCT01805245|Behavioral|Mindfulness Based Stress Reduction|Standard 8-week MBSR program; classes meet for 2.5 hours once weekly The health education control group meets at the same time and for the same amount of time
16146978|NCT01805232|Drug|artesunate|intravenous artesunate 80 mg/kg initially then after 8 hours then daily
16146979|NCT01805232|Drug|Quinine|quinine infusion 80 mg/kg every 8 hours till the patient can take orally
16146980|NCT01805219|Other|GPS and accelerometer recording (s) during exercises|
16146981|NCT01805206|Other|Assessment of urinary iFABP|
16146982|NCT01805206|Other|Administration of enteral feedings|
16146983|NCT01805193|Other|Computed tomography myocardial perfusion imaging|
16146984|NCT01805193|Other|Oxygen 15 labelled water positron emission tomography|
16146985|NCT01805180|Device|Granulocyte/Polymorphonuclear Cell Collection (COBE Spectra System)|In Arm 1 the first PMN cell collection will be performed using the Spectra Optia System and the second PMN cell collection using the COBE Spectra System.
16146986|NCT01805180|Device|Granulocyte/Polymorphonuclear Cell Collection (Spectra Optia System)|In Arm 2 the first PMN cell collection will be performed using the COBE Spectra System and the second PMN cell collection using the Spectra Optia System.
16146987|NCT01805167|Other|Electrophysiological study of the interindividual variability of vocal performance|
16146988|NCT01805154|Device|CRT Patients|This is a group of patients who are receiving bi-ventricular pacing therapy from CRT device.
16146989|NCT01805128|Other|Facial recognition of emotions|The purpose is to consider the recognition of emotions expressed on face in patients with a schizophrenic disorder, autism and in healthy subjects.
16146990|NCT01805128|Other|understanding metaphors|Explore understanding of figurative language, including metaphor, in schizophrenic patients, autistic and healthy, and well understand how patients develop an interpretation from access to speaker's communicative intentionality (theory mind).
16146991|NCT01805128|Other|Attribution of intentionality to others in social situations depending on the type of situation|Compare the style of attribution of intentions in three populations of subjects: schizophrenic, autistic and healthy.
16146992|NCT01805115|Drug|Oral misoprostol|Patients were randomly allocated at the outpatient department into 4 groups with a ratio of 1:1:1:1: the oral, sublingual, vaginal, and no misoprostol group received all 400 μg of misoprostol (two tablets of Cytotec; 200 μg). All misoprostol tablets were identical and patients were blinded to group allocation
16146993|NCT01805115|Drug|Sublingual misoprostol|Patients were randomly allocated at the outpatient department into 4 groups with a ratio of 1:1:1:1: the oral, sublingual, vaginal, and no misoprostol group received all 400 μg of misoprostol (two tablets of Cytotec; 200 μg). All misoprostol tablets were identical and patients were blinded to group allocation
16146994|NCT01805115|Drug|Vaginal misoprostol|Patients were randomly allocated at the outpatient department into 4 groups with a ratio of 1:1:1:1: the oral, sublingual, vaginal, and no misoprostol group received all 400 μg of misoprostol (two tablets of Cytotec; 200 μg). All misoprostol tablets were identical and patients were blinded to group allocation
16146995|NCT01805115|Drug|Control|The control group was not given any cervical priming agents or placebo.
16146996|NCT01805089|Drug|Melatonin 3 mg|Melatonin vs. Placebo
16146997|NCT01805076|Procedure|Breast surgery|
16146998|NCT01805076|Procedure|Magnetic resonance imaging|
16146999|NCT01805076|Procedure|Mammography|
16147000|NCT01805063|Procedure|Forearm Vascular Study|Forearm venous occlusion plethysmography to measure forearm blood flow during intra-arterial infusion of the vasodilators Verapamil (10-100 µg/min), bradykinin (100-1000 pmol/min), sodium nitroprusside (2-8 µg/min) and Acetylcholine (5-20 µg/min).
16147001|NCT01805063|Procedure|Badimon Chamber|Ex-vivo assessment of thrombus formation using the Badimon Chamber
16147002|NCT01805050|Procedure|Arthroscopically repair of the anterior shoulder instability|Arthroscopically repair of the anterior shoulder instability
16147003|NCT01805037|Drug|brentuximab vedotin|Given IV
16147004|NCT01805037|Biological|rituximab|Given IV
16147005|NCT01805037|Other|laboratory biomarker analysis|Correlative studies
16147006|NCT01805024|Drug|Omigapil|Cohort 1 0.02 mg/kg/day Cohort 2 0.08 mg/kg/day Cohort 3a 0.04 mg/kg/day Cohort 3b 0.06 mg/kg/day
16147007|NCT01805011|Other|minimum 4 months of breastfeeding|
16147008|NCT01804998|Procedure|Laparoscopic Sentinel Node Biopsy|Laparoscopic Sentinel Node Biopsy or Stomach Preserving Surgery could be performed in the experimental arm.
16147009|NCT01804998|Procedure|Laparoscopy Assisted Gastrectomy|In the control arm, laparoscopy assisted gastrectomy with lymph node dissection (D1+ or more) will be performed.
16147010|NCT01804985|Drug|Imatinib|Imatinib, nilotinib or dasatinib; de-escalated to half the standard dose for 12 months. If on imatinib, the dose should be decreased to 200mg daily;
16147011|NCT01804985|Drug|nilotinib|Imatinib, nilotinib or dasatinib; de-escalated to half the standard dose for 12 months. if on nilotinib to 200mg twice daily (which is half the standard dose for second line use, since it is anticipated that the vast majority of nilotinib entrants will be receiving 400mg twice daily because of prior imatinib intolerance);
16147012|NCT01804985|Drug|dasatinib|Imatinib, nilotinib or dasatinib; de-escalated to half the standard dose for 12 months. If on dasatinib then to 50 mg daily.
16147013|NCT01804972|Other|Verbal and written information|Patients will receive verbal information supplied by the attending doctor and also written information in the form of patient information leaflets
16147014|NCT01804972|Other|Verbal and electronic information|Patients will receive verbal information by the attending doctor and also be provided with a web address to access electronic patient information.
16147015|NCT01804959|Dietary Supplement|Vivomixx probiotics|
16147016|NCT01804946|Drug|Ergoferon|Safety and Efficiency of Ergoferon in treatment of Influenza
16147017|NCT01804946|Drug|Oseltamivir|Safety and Efficiency in treatment of Influenza
16147018|NCT01804933|Drug|profound neuromuscular blockade|Rocuronium dose will be infused to maintain a depth of NMB to PTC 1~2 intraoperatively
16147019|NCT01804920|Dietary Supplement|D-serine|
16147020|NCT01804920|Dietary Supplement|Placebo|
16147021|NCT01804907|Behavioral|Cognitive Behavioral Therapy|
16147022|NCT01804907|Behavioral|Behavioral Modification|
16147023|NCT01804881|Behavioral|Lifestyle counseling|Six week program to address problematic eating
16147024|NCT01804868|Other|case vignette tutorial|The web tutorial will be composed of 4 case vignettes. A case vignette is a clinical scenario based on clinical practice. It will ask a clinical problem the student will have to answer by reading a research article on a randomized clinical trial. Then he will have to answer questions about this article which are related to the major methodological points of a randomized trial. All these steps are available on a secured website.
16147025|NCT01804868|Other|passive web presentation on research regulation|The presentation will be a web-based voice commented video presentation on research regulation. It will allow to preserve a minimal blinding of participants, since the participants will not be informed of the intervention evaluated and will have the opportunity to follow the other intervention after the evaluation.
16147026|NCT01804855|Behavioral|W82GO|MDT delivered obesity intervention integrating behavioural change methods in order to reduce obesity; improve nutrition; increase physical activity; improve sleep; reduce sedentarism and increase self-esteem
16147027|NCT01804855|Device|smartphone application|Behavior change smartphone application for adolescents aiming to reduce obesity
16147028|NCT01804842|Drug|Met DR|metformin delayed-release tablets
16147029|NCT01804829|Biological|Civacir® 10%|The active ingredient is Human Immunoglobulin G (IgG) which is a normal constituent purified from human source plasma containing a diversity of antibodies targeting the Hepatitis C Virus.
16147030|NCT01804816|Procedure|Acupuncture|Standardized acupuncture administration for 10 sessions.
16147031|NCT01804816|Other|No Intervention|No intervention during this period. This was a control period. Each subject acted as their own control.
16147032|NCT01804803|Procedure|Use of software-implemented glucometer for real-time collection and transmission of measured glucose values to remote server.|"Device is a smartphone-connected glucometer. The smartphone will be implemented with a software for real-time collection and transmission of measured glucose values to the remote server. Thus, the glucometer will be made hot for real-time and anywhere data transmission. In addition, at the time of blood glucose measuring, the patient will enter information on whether the measurement is being performed in the pre-prandial, post-prandial or absorptive periods, and will indicate which meals the measurement refers to (i.e., breakfast, lunch, dinner, snack). SMBG results will be immediately transmitted to the remote server, which will perform data collection and analysis, and provide feed-back to the patient and the medical staff according to pre-defined specific algorithms (Decision Supported Software, DSS)."
16147033|NCT01804803|Procedure|Use of regular glucometer|
16147034|NCT01804790|Drug|mFolfirinox|Investigational arm: Neoadjuvant chemotherapy mFolfirinox, 4 cycles: oxaliplatin: 85 mg/m² in 2 hours at D1 irinotecan: 180 mg/m² in 90 min at D1 folinic acid: 400 mg/m² simultaneously in 2 hours at D1 during the irinotecan infusion 5-FU: 2400 mg/m² continuous infusion during 48 hours (1200 mg/m² at D1 and D2), every 14 days during 2 months (4 cycles), then CRT (50 Gy (2 Gy/session, 25 fractions) + capecitabine 800 mg/m² twice a day 5 days/7), then surgery with TME 6-8 weeks after chemoradiation, and 4 months of adjuvant CT depending on the center's choice.
16147035|NCT01804790|Radiation|Radiotherapy 50 Gy|5 radiations per week of 2 Gy for 5 weeks
16147036|NCT01804790|Drug|Capecitabine|1600 mg/m² (800 mg/m² twice daily) for 5 weeks
16147037|NCT01804790|Procedure|TME surgery|
16147038|NCT01804790|Drug|mFolfox6 or capecitabine|oxaliplatine 85 mg/m² (day 1 of cycle; perfusion in 2h), folinic acid 400 mg/m² (day 1 of cycle perfusion in 2h), 5-FU (bolus 400 mg/m² in 10 min and 2400 mg/m² perfusion continuous 46h). Arm A - 12 cycles ; Arm B - 6 cycles OR Capecitabine 2500 mg/m²/day (Each cycle consists of 1250 mg/m² twice daily for D1-14 then pause therapeutic from D15-21). Arm A - 8 cycles; Arm B 4 cycles.
16147039|NCT01804777|Drug|Amiloride|"Amiloride 10 mg taken every day for two weeks, along with adherence to specified diet.
~On day 14 titrate dose up to Amiloride 20 mg, take every day for two weeks after completion of two week intake of Amiloride 10 mg, along with adherence to specified diet."
16147040|NCT01804777|Drug|HCTZ|"HCTZ 12.5 mg taken every day for two weeks, along with adherence to specified diet.
~On day 14 titrate dose up to HCTZ 25 mg taken every day for two weeks after completion of two week intake of HCTZ 12.5 mg, along with adherence to specified diet"
16147041|NCT01804738|Other|Jasmine rice|Standardised rice:cooking liquid ratio for 50g available carbohydrate portion
16147042|NCT01804738|Other|Parboiled basmati rice|Standardised rice:cooking liquid for 50g available carbohydrate portion
16147043|NCT01804712|Drug|rituximab|Rituximab will be administered intravenously at a dose of 375 mg/m2 of body surface area once per week for 4 weeks (Days 1, 8, 15, and 22 of a 28-day cycle).
16147044|NCT01804686|Drug|Ibrutinib|Ibrutinib will be given orally as capsules, once daily continuously, according to the current dosing regimen established in the parent ibrutinib clinical study (560 mg, 420 mg, 280 mg, or 140 mg), at approximately the same time each day.
16147254|NCT01803074|Drug|Tenofovir|Tenofovir
16147255|NCT01803074|Drug|Emtricitabine|Emtricitabine
16147045|NCT01804673|Drug|Fentanyl-ITS|Fentanyl Iontophoretic Transdermal (through the skin) System (ITS) will release fentanyl at the rate of 40 microgram (mcg) (1 dose) to maximum of 240 mcg per hour (6 doses) but not more than 3.2 milligram (mg) (80 doses) per 24 hours. The duration of study treatment will be 72 hours.
16147046|NCT01804660|Other|No study treatments administered|
16147047|NCT01804647|Other|No study treatments administered - blood draws only|
16147048|NCT01804634|Drug|Cyclophosphamide|preparative regimen
16147049|NCT01804634|Drug|Fludarabine|
16147050|NCT01804634|Radiation|low dose total body irradiation|
16147051|NCT01804634|Drug|Melphalan|
16147052|NCT01804634|Drug|Tacrolimus|
16147053|NCT01804621|Behavioral|Health Newsletter|Participants received a health newsletter with articles about general health articles, as well as targeted health articles (differs by condition).
16147054|NCT01804608|Other|Strength|
16147055|NCT01804608|Other|Sensorimotor|
16147056|NCT01804595|Other|Sunscreen|
16147057|NCT01804595|Behavioral|Text-Message Reminders|
16147058|NCT01804595|Other|Sunscreen and Text Message Reminders|
16147059|NCT01804595|Behavioral|Education|
16147060|NCT01804582|Other|Family Navigator consultation|"Telephone contact from the trained family navigator to the parent participant several times over the 90 day study time period. Components of the service include the following:
~(1)family engagement; (2) inquiry about psychosocial resource needs related to schools, outpatient child treatment, support programs, or mental health resources for other household family members; (3) discuss potential benefits/challenges of options and parent preferences/priorities for care; (4) assessment on perceived barriers to seeking resources; (5) collaborative problem solving to address barriers; (6) discuss options for follow up plan."
16147061|NCT01804569|Other|moxibustion|modernly developed moxibustion treatment device with safe cover on top of it.
16147062|NCT01804556|Procedure|Myofascial trigger point injections on gastrocnemius muscle|On the first visit (T0), we record numeric rating scale (NRS), the frequency of cramps and insomnia severity index using questionnaires. Then we check trigger points of gastrocnemius muscle and inject lidocaine 1 ~ 2 ml each up to four points. One week later (T1) we record numeric rating scale (NRS), the frequency of cramps and insomnia severity index again, check trigger points, and if any, inject lidocaine. If the patient do not come, we get numeric rating scale (NRS), the frequency of cramps and insomnia severity index over the telephone. Two weeks after the first visit (T2), we repeat the procedure of the first visit (T0). And four weeks after the first visit (T3) we record numeric rating scale (NRS), the frequency of cramps and insomnia severity index through face-to-face interview or by telephone.
16147063|NCT01804543|Drug|Ranolazine|ranolazine 500 mg, then 1000 mg twice a day
16147064|NCT01804530|Drug|PLX7486 TsOH|PLX7486 TsOH capsules, 50mg
16147065|NCT01804504|Behavioral|Nutrition education|The intervention group will be sent out a series of education materials, be arranged to attend lectures(once a month), dietary guidance or nutrition consultation at regular intervals(once every 2 weeks).
16147066|NCT01804491|Other|Motion Analysis|3D Motion analysis with retroflective markers on the skin (Vicon camera system) of the foot and lower leg (kinematics), walking over force plate (kinetics) and pressure plates (plantar pressure distribution).
16147067|NCT01804478|Behavioral|Mild pneumatic compression|
16147068|NCT01804465|Drug|SipT Treatment|"All patients will receive standard of care SipT treatment every two weeks for a total of 3 treatments. The three treatments usually take about 30 days to complete.
~SipT treatment is given in three 1 hour infusions. Each SipT treatment is generated from a standard blood cell-collection procedure (called leukapheresis) performed 2-3 days prior to the infusion."
16147069|NCT01804465|Drug|Ipilimumab|Ipilimumab will be given by IV over 90 minutes every 3 weeks. Patients will be monitored during the infusion and up to 1 hour post-infusion.
16147070|NCT01804452|Other|Observational Study|
16147071|NCT01804413|Drug|Pegvisomant|Pegvisomant 1 mg/kg injection 3 days before the glucagon test.
16147072|NCT01804413|Drug|Regular insulin|0.1-0.15 units/kg
16147073|NCT01804400|Drug|QAW039|
16147074|NCT01804400|Drug|Montelukast|
16147075|NCT01804400|Drug|Placebo|
16147076|NCT01804387|Drug|telbivudine plus adefovir|telbivudine 600 mg qd plus adefovir 10 mg qd
16147077|NCT01804387|Drug|lamivudine plus adefovir|lamivudine 100 mg qd plus adefovir 10mg qd
16147078|NCT01804374|Drug|Sorafenib|Sorafenib tablet 200 milligrams packed in bottle containing 140 tablets. Sorafenib will be administered orally twice daily at the same time every day. Two 200 mg tablets will be taken either one hour before or two hours after a meal followed by a glass of water in the morning and in the evening. In general, patient should have a low to moderate fat meal. Patients will receive Sorafenib until progression, toxicity, withdrawal of informed consent or clinical investigator decision
16147079|NCT01804374|Drug|Everolimus|Everolimus is formulated in tablets of 2.5 or 5 mg strength, blister-packed under aluminum foil in units of 10 tablets. Everolimus will be administered orally once daily at the same time every day immediately after a meal, as a single dose of 5 mg. Patients should have a low-fat breakfast. After this light meal, study medication of Everolimus is to be taken. The tablets of Everolimus should not be chewed or crushed. Patients will receive Everolimus until progression, toxicity, withdrawal of informed consent or clinical investigator decision
16147080|NCT01804361|Drug|Haporine-S|1 or 2 drops twice a day at 12 hour interval for 12 weeks
16147081|NCT01804361|Drug|Restasis (cyclosporine 0.05%)|1 or 2 drops twice a day at 12 hour interval for 12 weeks
16147082|NCT01804348|Device|AL-SENSE 1-Step|a single AL-SENSE 1-Step to use up to 12 hours or until they notice any wetness.
16147083|NCT01804335|Drug|CD5789 0.01% Cream|CD5789 0.01% cream applied on the lesions once daily for twelve weeks.
16147084|NCT01804322|Other|Standardized educational plan|"The comprehensive and standardized educational plan consists in the discussion with the patient each of the following points:
~The cause and nature of the adverse event and/or drug interaction
~The tolerability profile of each drug present in the schedule
~The clinical manifestations associated with the current drug interactions
~Any contraindication to the use of over-the-counter drugs potentially interfering with the current treatment schedule
~The reasons for and the potential benefits of the suggested treatment change
~An encouragement to withdraw any potentially interfering or contraindicated drug"
16147085|NCT01804322|Other|usual care|usual care according to the participating Epilepsy Centers
16147086|NCT01804309|Procedure|Sentinel lymph node biopsy (SLNB)|The intervention (SLNB) is no different in the care of patients' in the study then in those who were not included in the past or will not be included after the trial terminates. SLNB is performed according to strict professional guidelines adopted by the National Institute of Oncology, Budapest, Hungary.
16147087|NCT01804296|Device|Repetitive transcranial magnetic stimulation (rTMS)|Active treatments with repetitive transcranial magnetic stimulation (rTMS) consists of treatment settings of 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.
16147088|NCT01804283|Procedure|ischemic postconditioning|"multiple brief ischemic-reperfusion episodes immediately after sustained ischemic insult
~Postconditioning was started at 30 s after aortic cross declamping, and the aorta was re-clamped for 30 s rendering global myocardial ischemia. Meanwhile aortic root suction was established during aortic re-clamping, and thereafter, the aortic clamp was released for 30 s for full myocardial reperfusion. The cycle was repeated three times after cardioplegic arrest."
16147089|NCT01804283|Procedure|double valve replacement|The double valve replacement is a procedure in which surgery is used to replace diseased aortic and mitral heart valves.
16147090|NCT01804283|Device|heart-lung machine|The heart-lung machine is commonly used in open heart surgery including double valve replacement to support the circulation during the operation.
16147091|NCT01804283|Device|Aortic cross-clamp|a surgical instrument used in cardiac surgery to clamp the aorta
16147092|NCT01804270|Device|Repetitive transcranial magnetic stimulation (rTMS)|Active treatments with repetitive transcranial magnetic stimulation (rTMS) consists of treatment settings of 120% magnetic field intensity relative to the patient's resting motor threshold, at 10 pulses per second (10 Hz) for 4 seconds, with an intertrain interval of 26 seconds for a total of 75 trains per treatment session.
16147093|NCT01804257|Other|Digital Health Feedback System|The digital health offering passively collects and records medication-taking behavior and other habits of daily living
16147094|NCT01804244|Drug|TMC278|1 25-mg tablet [27.5 mg as the hydrochloride salt) taken orally (by mouth) within 10 minutes after completion of a standardized breakfast on Day 1.
16147095|NCT01804231|Other|18F-FCH PET/MRI imaging|Patients will first undergo screening to ensure eligibility. If eligible, they will undergo one scan in a Hybrid PET/MRI scanner using 18F-FCH as the radiolabeled tracer.
16147096|NCT01804218|Drug|Nadolol|
16147097|NCT01804218|Drug|Placebo|
16147098|NCT01804205|Drug|Magnesium Sulfate|MgSO4 30 mg/kg in 0.9% physiological saline (total volume 100 ml) intravenously, for 10 min, and then continuous intravenous infusion of MgSO4 at a rate of 1 g/h during the surgical procedure until the maximum of 3 h
16147099|NCT01804205|Drug|Placebo|100 ml of 0.9% physiological saline, for 10 min, and then continuous intravenous infusion of saline at a rate of 33 ml/h during the surgical procedure until the maximum of 3 h
16147100|NCT01804192|Other|Acu-TENS|Systolic and diastolic blood pressures will be taken on the left arm by a digital blood pressure monitor (Mindray PM-8000 Express Patient Monitor, Bio-Medical Electricity, Hamburg, Germany). The mean arterial pressure (MAP) will be recorded from the machine. Three ECG electrodes will be applied over left and right clavicles and left upper quadrant of abdomen respectively and then connect to a digital patient monitor device (Mindray PM-8000 Express Patient Monitor, Bio-Medical Electricity, Hamburg, Germany). The heart rate (HR) will be measured. The ECG signals will be transferred to the PowerLab 16/30 (ADInstruments Pty Ltd. NSW, Australia) for data acquisition and analysis of the HRV.
16147101|NCT01804179|Other|Immunochemical Fecal Occult Blood Test (I-FOBT) Kit|Participants will receive an Immunochemical Fecal Occult Blood Test (I-FOBT) Kit (a home stool blood test) used as a first-step screening tool for colorectal cancer to take home. The research staff will provide instructions on how to use the kit.
16147102|NCT01804179|Other|Standard Intervention (SI) Educational Materials|"Screen for Life brochure"
16147103|NCT01804179|Other|CARES Intervention Educational Materials|Newly developed digital video disc (DVD) and booklet
16147104|NCT01804179|Other|Baseline Visit Survey|In both conditions, patients will participate in a Baseline Survey. Three brief items will be used to assess patient-provider discussion and recommendation: (1) Was colorectal cancer or colorectal cancer screening one of the things you discussed with the doctor or health care provider? (Yes/No). (2) If Yes, who brought the topic of colorectal cancer first? (patient/health care provider). (3) Did your doctor or health care provider recommend colorectal cancer screening? (Yes/No). These questions are necessary to evaluate the impact of interventions on patient-provider discussion of CRCS and provider recommendation of CRCS.
16147105|NCT01804179|Other|Follow-up Questionnaire|12 months after participants began to participate in the study, they will be contacted via telephone to complete a final set of questionnaires. Participants will be asked questions similar to those answered in baseline. This time they will ask about the participant's thoughts on the educational materials as well.
16147106|NCT01804166|Drug|Infliximab|This study will not restrict or introduce any therapeutic interventions, including medications. Participants may continue to receive infliximab as instructed by their personal physicians.
16147107|NCT01804166|Drug|Golimumab|This study will not restrict or introduce any therapeutic interventions, including medications. Participants may continue to receive golimumab as instructed by their personal physicians.
16147108|NCT01804153|Drug|Adipose-derived expanded stem cells|Intralesional application ASC
16147109|NCT01804127|Drug|R-CHOP|rituximab 375mg/m2 day 0, cyclophosphamide 750mg/m2 IV day 1, doxorubicin 50mg/m2 IV day 1, vincristine 1.4mg/m2 IV day1 (maximum: 2mg), prednisone 50mg PO days 1-5 twice per day
16147110|NCT01804114|Procedure|Pain management following hernia repair|Continuous infusion of local anesthetic via pain pump following hernia repair
16147111|NCT01804114|Procedure|Placebo for pain management following hernia repair|Continuous infusion of placebo via pain pump following hernia repair
16147112|NCT01804101|Other|Laboratory Biomarker Analysis|Correlative studies
16147113|NCT01804101|Drug|Liposomal Cytarabine-Daunorubicin CPX-351|Given IV
16147114|NCT01804088|Device|Formula™ 535 Iliac Balloon-Expandable Stent|Treatment of symptomatic vascular disease of the iliac arteries
16147115|NCT01804075|Drug|Methadone|To compare the duration of opiate medication treatment for babies on methadone versus those on morphine.
16147116|NCT01804075|Drug|Morphine|To compare the duration of opiate medication treatment for babies on methadone versus those on morphine.
16147117|NCT01804049|Drug|metformin|Metformin will be given at a dose of 850 mg orally once daily for 1 month with titration up to 850 mg orally twice daily for the remainder of the study.
16147118|NCT01804049|Drug|placebo|One placebo capsule by mouth once daily for 1 month followed by one placebo capsule by mouth twice daily for the remainder of the study.
16147119|NCT01804036|Drug|Zolpidem|Week 1: 10 mg Zolpidem daily for 1 week, Week 2: 10 mg Zolpidem daily for one week, taken as needed, Week 3: 5 mg Zolpidem daily for 1 week, taken as needed.
16147120|NCT01804036|Behavioral|Mind-Body Bridging|An awareness training program. One 2 hr class per week for 3 weeks - 2 hours per session
16147121|NCT01804023|Other|HEC placebo gel applicators|"Participants will handle, but not insert, 4 applicators containing HEC placebo gel.
~Participants will vaginally insert and removed 8 applicators containing HEC placebo gel. Gel will be expelled in to the vagina from only 2 applicators."
16147122|NCT01804010|Drug|Ivabradine and placebo|Single and repeated oral administrations of 3 doses of ivabradine (2.5, 5, and 10 mg). Subjects were given a single administration of ivabradine during Period 1 (P1), following a 3-day washout, they were given repeated administrations twice daily for 4.5 days during Period 2 (P2).
16147123|NCT01803997|Behavioral|Pink and Dude Chef Afterschool Cooking Program|12 educational cooking classes: two classes per week for six weeks (2 hours each)
16147124|NCT01803984|Device|MRI|
16147125|NCT01803984|Device|EndoPAT|The endothelial function will be measured with a noninvasive Peripheral Arterial Tone (PAT) signal technology using the EndoPAT device
16147126|NCT01803984|Other|Neuropsychological battery|The cognitive status in the patient cohort will be ascertained by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
16147127|NCT01803971|Other|Obtention of vascular access in out-of-hospital cardiac arrest patients according to the current strategy|Current strategy of obtention of a vascular access : first attempt by peripheral venous access and if failure switch to intraosseous route
16147128|NCT01803958|Radiation|partial breast irradiation|
16147129|NCT01803958|Radiation|whole breast irradiation|
16147130|NCT01803945|Drug|AVE8112|
16147131|NCT01803945|Drug|Placebo|
16147132|NCT01803932|Behavioral|Male-focused group violence prevention intervention|
16147133|NCT01803919|Device|Silver Alloy-Coated Urinary Catheters|
16147134|NCT01803919|Device|Conventional Urinary Catheter|
16147135|NCT01803880|Device|Mechanical Debridement|mechanical shaver that removes areas of damaged tissue
16147136|NCT01803880|Device|RF-Based Debridement|Electrical energy that removes areas of damaged tissue (Coblation®)
16147137|NCT01803867|Drug|rHIgM22|Administered via IV infusion
16147138|NCT01803841|Procedure|Transradial coronary angiography and intervention|
16147139|NCT01803841|Procedure|Transfemoral coronary angiography and intervention|
16147140|NCT01803828|Drug|Tadalafil|20 mg/die (1 capsule)
16147141|NCT01803828|Drug|Placebo|Placebo 20 mg/die (1 capsule)
16147142|NCT01803802|Behavioral|Expressive writing|Five sessions of 30 minutes of expressive writing
16147143|NCT01803789|Device|Single Kirschner Wire|
16147144|NCT01803789|Device|Double Kirschner Wire|
16147145|NCT01803776|Behavioral|lifestyle counseling|The physical activity and dietary intervention is based on the Finnish physical activity and dietary recommendations. The children and their parents in the intervention group undergo individualized and family-based physical activity and dietary intervention between the baseline and 2-year follow-up examinations. The children and their parents meet a physical activity specialist and a nutritionist who give detailed and individualized instructions on health promoting physical activity and diet at months 0, 1.5, 3, 6, 12, and 18 with a specific topic at each visit. Between the 2-year follow-up and 8-year follow-up examinations, the intervention continues with yearly physical activity and dietary counseling sessions. The children in the intervention group, particularly those who do not attend organized sports or exercise, will also be encouraged to participate in after-school exercise clubs organized by trained exercise instructors of the study.
16147146|NCT01803763|Drug|Omalizumab (Xolair)|Fixed dose of 300 mg omalizumab is subcutaneously administered in total 4 monthly doses
16147147|NCT01803763|Drug|Placebo|Fixed dose of placebo is subcutaneously administered in total 4 monthly doses
16147148|NCT01803750|Behavioral|in-depth, semi-structured interviews|In-depth interviews will be conducted by the Principle Investigator and will use a combination of open-ended and closed, fixed response questions. Interviews will be audio recorded if the participant agrees, and answers to fixed response questions will be marked for complete analysis. The data collection portion of the study is estimated to take approximately 8 months. Areas to be addressed in the open-ended portion of the interview include: 1) Knowledge, attitudes and beliefs toward evidence-based cancer screening and prevention approaches 2) Barriers to implementing evidence-based cancer screening practices in the individual provider's clinical setting 3) Preferences for mechanisms of information dissemination and implementation and 4) Ideas and methods to facilitate evidence-based practices to improve cancer screening in the Latino population. A community-based participatory committee (CBPC) will be formed with 5-7 key informants identified during the interview process.
16147149|NCT01803737|Behavioral|Standard Behavioral Weight Loss Intervention (SBWL)|Included changing eating behaviors, increasing physical activity, and attending regular group weight loss meetings.
16147150|NCT01803737|Behavioral|Campaign Intervention (CI)|Included changing eating behaviors and increasing physical activity, however participants will not attend regular meetings. Instead they will attend two weekly meetings at weeks 0 and 12. During the weeks they are not scheduled to attend in-person weekly meetings (weeks 1-11), they will receive education materials via e-mail. They will also have the opportunity to earn points towards prizes by reporting diet and physical activity behaviors, and body weight via e-mail.
16147151|NCT01803711|Drug|Desvenlafaxine|
16147152|NCT01803711|Dietary Supplement|Omega 3 Fatty acids|
16147153|NCT01803711|Drug|Placebo (for Omega 3 fatty acid supplement)|
16147154|NCT01803698|Behavioral|Training in the use of IOM charts|
16147201|NCT01803360|Drug|Neridronate|Neridronate 100 mg solution for infusion: 4 intravenous administrations in a course of 10 days treatment
16147202|NCT01803347|Drug|◦Drug: ASCs. + fibrin glue|Experimental group
16147203|NCT01803347|Drug|fibrin glue|•Active Comparator: Fibrin glue Intervention: Drug: Fibrin adhesive
16147332|NCT01802541|Dietary Supplement|diacylglycerol oil|
16147155|NCT01803672|Behavioral|health talk and adventure-based training|To develop an integrated programme for Hong Kong Chinese childhood cancer survivors, an advisory committee was set up which included the three healthcare professionals (researchers), two school principals, two professional adventure-based trainers and one assistant professor of Sports and Recreation Management, ensuring the adequate 'dosage' of the intervention and the feasibility of implementing such programme for Hong Kong childhood cancer surviviors.
16147156|NCT01803672|Behavioral|Placebo control|They will be invited to attend leisure activities organized by a community centre in four different days during the study period. Activities will include cartoon film shows, handicraft workshops, chess games, health talks on the prevention of influenza and healthy diet, day visit to museum and theme park.
16147157|NCT01803659|Dietary Supplement|b-carotene|
16147158|NCT01803659|Dietary Supplement|retinyl palmitate|
16147159|NCT01803659|Dietary Supplement|placebo|
16147160|NCT01803646|Drug|AM-101|AM-101 gel for intratympanic injection
16147161|NCT01803646|Drug|Placebo|Placebo gel for intratympanic injection
16147162|NCT01803633|Other|Cheddar cheese|Tillamook medium cheddar cheese brand
16147163|NCT01803633|Other|Vegan cheese|Daiya brand vegan cheese
16147164|NCT01803607|Drug|odanacatib|odanacatib 50 mg oral tablet
16147165|NCT01803607|Other|placebo to odanacatib|dose-matched placebo to odanacatib, oral tablet
16147166|NCT01803594|Dietary Supplement|Krill Oil|Neptune Krill Oil Gold
16147167|NCT01803594|Dietary Supplement|Lutein|Jarrow Formulas
16147168|NCT01803594|Dietary Supplement|Nicotinic acid|Natures Way
16147169|NCT01803594|Dietary Supplement|Dairy phospholipids|PC700 manufactured by Fonterra
16147170|NCT01803594|Other|Control|Control shake without dietary supplements
16147171|NCT01803581|Other|X92001327|
16147172|NCT01803581|Other|RID shampoo|
16147173|NCT01803568|Other|Exercise|12 weeks of exercise; 4 times pr week
16147174|NCT01803555|Drug|Budesonide/Formoterol SPIROMAX®|
16147175|NCT01803555|Drug|SYMBICORT® TURBOHALER®|
16147176|NCT01803542|Radiation|Stereotactic Radiation|Participants will receive high doses of radiation treatment to tumours in the lung for 3 to 10 treatment sessions over a total of about 1 to 2 weeks.
16147177|NCT01803529|Other|heat-pack with massage|
16147178|NCT01803529|Other|heat-pack only|
16147179|NCT01803516|Behavioral|questionnaires|This study will be offered to patients who, at the time of consultation are identified as having had adjuvant breast radiation treatment following surgical treatment for breast cancer and developed radiation-induced telangiectasias. The Skindex-16 and BREAST-Q questionnaires will be used to evaluate the quality of life of The study participants. For each instrument, for each evaluation time point, QOL scores will be summed and transformed into a scale from 0-100. Descriptive statistics will be used to describe the QOL of the study participants.
16147180|NCT01803503|Drug|Docetaxel|Docetaxel 75mg/m2 day 1, every 3 weeks
16147181|NCT01803503|Drug|Sunitinib|7 days of sunitinib 12.5mg orally daily during each cycle
16147182|NCT01803477|Drug|once daily for two consecutive days (Picato)|
16147183|NCT01803464|Device|Low-magnitude vibration|Children will receive a daily low-magnitude vibration treatment.
16147184|NCT01803464|Drug|Botox|Children who are candidates to receive Botox as part of their standard of care.
16147185|NCT01803451|Drug|exendin-(9-39)|hyperglycemic clamp-meal tolerance test is designed to assess insulin secretion before and after meal ingestion
16147186|NCT01803451|Drug|exendin -(9-39)|2-day meal tolerance tests with labeled oral and IV glucose using exendin-(9-39) infusion are designed to evaluate the role of GLP-1 signaling on glucose tolerance and glucose kinetics.
16147187|NCT01803438|Device|cryoballoon ablation system|
16147188|NCT01803438|Drug|Antiarrhythmic Drugs|AAD therapy based on hospital clinical practice according to ESC Guidelines 2012
16147189|NCT01803425|Other|Synflorix™ data collection|Safety monitoring and evaluation: recording of all AEs during the study period using diary cards, follow-up visit or telephone contact. Recording of SAEs throughout the study period for each subject.
16147190|NCT01803412|Drug|Drisapersen|Drisapersen will be supplied as 3 mL (milliliter) vials containing 1 mL sterile solution of 200 mg/mL strength. Each subject will receive drisapersen 3 mg/kg administered IV once a week, continuously throughout their duration of participation
16147191|NCT01803412|Drug|Drisapersen|Drisapersen will be supplied as 3 mL (milliliter) vials containing 1 mL sterile solution of 220 mg/mL strength. Each subject will receive drisapersen 6 mg/kg administered SC once a week, either continuously or intermittently (for 8 weeks, followed by 4 weeks of no dosing) throughout their duration of participation
16147192|NCT01803412|Drug|Drisapersen|Drisapersen will be supplied as 3 mL (milliliter) vials containing 1 mL sterile solution of 220 mg/mL strength. Each subject will receive drisapersen 6 mg/kg administered SC once a week, either continuously or intermittently (for 8 weeks, followed by 4 weeks of no dosing) throughout their duration of participation
16147193|NCT01803399|Drug|GSK1322322 1200 mg|GSK1322322 will be supplied as white to slightly colored lyophilized powder 400 mg/vial for injection. Single dose of GSK1322322 1200 mg (3 vials) will be administered IV over 60 minutes
16147194|NCT01803399|Drug|GSK1322322 3000 mg|GSK1322322 will be supplied as white to slightly colored lyophilized powder 400 mg/vial for injection. Single dose of GSK1322322 3000 mg (8 vials) will be administered IV over 60 minutes
16147195|NCT01803399|Drug|Placebo|Placebo will be supplied as 0.9% sodium chloride solution. Single dose of placebo will be administered IV over 60 minutes
16147196|NCT01803399|Drug|Moxifloxacin|Moxifloxacin will be supplied as oblong, dull red film coated tablets of 400 mg strength. Single dose of moxifloxacin 400 mg will be administered orally
16147197|NCT01803386|Device|EIM Measurements|EIM measurements are taken by applying saline to the skin and placing a sensor on patients' muscles that will record electrical activity. Electrical current is generated by this machine, but patients will not be able to feel it. The electrical activity recorded is returned to the machine and analyzed by a computer.
16147198|NCT01803373|Drug|Treatment A (reference)|One tablet equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
16147199|NCT01803373|Drug|Treatment B|Five 20-mg water dispersable tablets equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
16147200|NCT01803373|Drug|Treatment C|5 grams (ie,20mg/g) equivalent to a single 100-mg dose of TMC207 taken orally (by mouth) once.
16147204|NCT01803334|Other|Marking abdomen|If the patient is randomized to the marking the abdomen group (study group) she will then have the anticipated incision needed to place the trocars during her surgery marked on her abdomen by the surgeon attending physician involved in the patient care during the preoperative counseling visit.
16147205|NCT01803321|Drug|rilonacept (IL-1 Trap)|
16147206|NCT01803321|Other|Placebo|
16147207|NCT01803308|Drug|SB9200|Part A open-label, single ascending doses of SB9200 from 100mg - 1500mg.
16147208|NCT01803308|Drug|SB9200|Part B randomised 6:2 (active:placebo) using recommended Part B starting dose, and ascending to up to 1500mg for 7-14 days of dosing.
16147209|NCT01803308|Drug|Placebo|Part B randomised 6:2 (active:placebo) using anhydrous lactose capsules identical to active comparator, minus active ingredient.
16147210|NCT01803295|Device|40 mg MMC gel|A reverse thermal biodegradable gel (TC-3) (low viscosity at 5°C gel appearance at body temperature)for drug retention in the urinary bladder.
16147211|NCT01803295|Other|Standard of care MMC mixed with water|Standard of care 40mg MMC mixed with water
16147212|NCT01803295|Device|80 mg MMC gel|A reverse thermal biodegradable gel (TC-3) (low viscosity at 5°C gel appearance at body temperature)for drug retention in the urinary bladder
16147213|NCT01803282|Drug|Andecaliximab|Administered intravenous infusion
16147214|NCT01803282|Drug|Gemcitabine|Administered intravenously on Days 1, 8, and 15 of each 28-day treatment cycle
16147215|NCT01803282|Drug|Nab-paclitaxel|Administered intravenously on Days 1, 8, and 15 of each 28-day treatment cycle
16147216|NCT01803282|Drug|Carboplatin|Administered intravenously on Day 1 of each 21-day treatment cycle
16147217|NCT01803282|Drug|Pemetrexed|Administered intravenously on Day 1 of each 21-day treatment cycle
16147218|NCT01803282|Drug|Leucovorin|Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
16147219|NCT01803282|Drug|Oxaliplatin|Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
16147220|NCT01803282|Drug|5-FU|Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
16147221|NCT01803282|Drug|Bevacizumab|Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
16147222|NCT01803282|Drug|Irinotecan|Administered intravenously on Days 1 and 15 of each 28-day treatment cycle
16147223|NCT01803282|Drug|Paclitaxel|Administered intravenously on Days 1, 8 and 15 of each 28-day treatment cycle (Breast cancer) or on Day 1 of each 21-day treatment cycle (NSCLC)
16147224|NCT01803269|Drug|topotecan hydrochloride|Given IV
16147225|NCT01803269|Drug|cyclodextrin-based polymer-camptothecin CRLX101|Given IV
16147226|NCT01803243|Other|Ankle foot orthosis|Ankle foot orthoses are a common treatment method to control the foot position during walking and to prevent ankle plantar flexion contractures in cerebral palsy patients.
16147227|NCT01803243|Other|Shoe insole|The heel of the shorter leg of the patient is lifted by a shoe insole. This procedure is commonly applied with leg length differences of up to 20mm.
16147228|NCT01803243|Other|Modified shoe with sole lift|The heel of the shorter leg of the patient is lifted by building up the sole of the shoe (shoe sole lift). This procedure is commonly applied with leg length differences of 20mm and more.
16147229|NCT01803230|Dietary Supplement|creatine supplementation|creatine supplementation
16147230|NCT01803230|Dietary Supplement|Placebo|
16147231|NCT01803217|Other|pacemaker programming to mode switch to atrial pacing versus atrioventricular hysteresis function|
16147232|NCT01803204|Other|Booklet - Preoperative Educational|the patients receive a booklet during the preoperative phase. The educational session with a booklet will occur before the surgery.
16147233|NCT01803191|Drug|Fosfomycin 3 g|Unique oral dosis of fosfomycin 1 hour before biopsy
16147234|NCT01803191|Drug|Ciprofloxacin 500 mg|Unique oral dosis of ciprofloxacin 500 mg, 1 hour before biopsy
16147235|NCT01803178|Dietary Supplement|Plant Sterols|
16147236|NCT01803178|Dietary Supplement|Placebo Product|
16147237|NCT01803165|Procedure|Single shot femoral and sciatic nerve block|Ultrasound will be performed with a linear 10- to 13-Megahertz probe while performing the nerve block. Standard American Society of Anesthesiology monitors will be applied and the patient sedated at the discretion of the anesthetic team. Complications such as vascular puncture, pain on injection, or systemic toxicity will be recorded. A perineural dosing regimen for the regional blocks will be as follows: (femoral block) 20cc of 0.5% ropivicaine and (sub-gluteal posterior sciatic block) 20cc of 0.2% ropivicaine. Epinephrine will be withheld from the local anesthetic in order to prevent the potential of further ischemic complications.
16147238|NCT01803152|Biological|Dendritic Cells Vaccine|Subjects will receive DC Vaccine administered once weekly, via intradermal injection, for 4 weeks for a total of four vaccinations, per study protocol.
16147239|NCT01803152|Biological|Lysate of Tumor|Post-DC Vaccine therapy. Up to 1.5 mg of Lysate of tumor per dose administered via intradermal injection at intervals defined by study protocol.
16147240|NCT01803152|Drug|Gemcitabine|Post-surgery, Leukapheresis and clearance of subject. Gemcitabine 1000 mg/m2 IV will be administered once weekly for 3 weeks per study protocol.
16147241|NCT01803152|Drug|Imiquimod|Subjects will self-apply Imiquimod topically to each designated vaccine site before and after scheduled administrations of DC Vaccine or Lysate, per study protocol.
16147242|NCT01803152|Procedure|Leukapheresis|Baseline, post-surgery blood draw via catheter to obtain peripheral blood mononuclear cells (PBMCs) from which Dendritic cells will be obtained.
16147243|NCT01803139|Device|Adjuvant breast radiotherapy|Adjuvant radiotherapy delivering 50 Gy in 25 treatments, with an additional boost dose of 16 Gy at the discretion of the radiation oncologist.
16147244|NCT01803113|Device|Sofia hCG FIA|Qualitative detection via immunofluorescence technology of increased level of hCG present in urine.
16147245|NCT01803100|Other|No intervention|There is no intervention in this trial
16147246|NCT01803087|Drug|Test treatments CHF 1535 100/6 pMDI (Foster®) TEST1|
16147247|NCT01803087|Drug|CHF 1535 100/6 pMDI (Foster®) using AeroChamber Plus™ (TEST 2).|
16147248|NCT01803087|Drug|BDP pMDI 100 µg (Qvar®) plus formoterol fumarate pMDI 6 µg (Atimos®) (REF)|
16147249|NCT01803087|Drug|CHF 1535 100/6 pMDI (Foster®) (CTR)|
16147250|NCT01803074|Drug|BMS-955176|BMS-955176
16147251|NCT01803074|Drug|Placebo matching with BMS-955176|Placebo matching with BMS-955176
16147256|NCT01803061|Behavioral|WebCan|Provide computerized PRO (Patient Reported Outcome) to treating physician at the point of care to assess late effects after head and neck cancer
16147257|NCT01803035|Drug|LTX-109 1 %|
16147258|NCT01803035|Drug|LTX-109 2 %|
16147259|NCT01803035|Drug|Placebo gel|
16147260|NCT01803009|Behavioral|Patient views NCI CRC RAT|
16147261|NCT01803009|Behavioral|View presentation regarding current chance of having an advanced adenoma|
16147262|NCT01802996|Drug|Magnesium Isoglycyrrhizinate Injection|200mg IV on day 1-5
16147263|NCT01802970|Drug|Anakinra plus Standard of Care|Patients will undergo a 2-week run-in treatment of daily anakinra alone. This will be followed by daily anakinra (100 mg SC) plus the physician's chemotherapy ( TPC) choice of standard of care (SOC) for a maximum of 6 months.TPC choice includes nab paclitaxel (100 mg/m^2 Intravenous on day 1,8 &15 of a 28 day cycle), or capecitabine (1000mg/m^2 per oral; BID choice: 14 days on, 7 days off OR 7 days on, 7 days off of a 21 day cycle), or eribulin (1.4 mg/m^2 intravenous on day 1 & 8 of a 21 day cycle), or vinorelbine (25mg/m^2 on day 1,8,15 of a 28 day cycle). After 6 months, patients may continue their SOC treatment alone until disease progression or intolerable toxicity.
16147264|NCT01802957|Other|Training of health workers in Basic Obstetric Emergency Care|Health workers at the eight health centers will be trained in maternal, newborn, and child health (MNCH) care, including all basic emergency obstetric and neonatal care (BEmONC) signal functions and other essential MNCH services. The training is a three week competency-based curriculum developed recently by the Ethiopian Federal Ministry of Health (FMoH).
16147265|NCT01802957|Other|Hospital-health center networking system|A key intervention will be the creation of an effective, formalized networking system between Saint Paul Millennium Hospital and its eight satellite health centers in Addis Ababa. The networking system will create a conducive environment for the transfer of knowledge and skills between health care providers working at the hospital and in the health centers. Monthly review meetings will bring together staff from the hospital and health centers, and dedicated cell phones will be distributed to improve communication between the networked facilities.
16147266|NCT01802957|Other|Post Basic Emergency Obstetric Training Mentorship|At Saint Paul Millennium Hospital and the health centers, providers who have undergone BEmONC training will undergo regular monthly mentorship visits for the first six months post training. The frequency of visits after six months will be adjusted based on the retention of BEmONC skills and provider performance
16147267|NCT01802957|Other|Team-Based Supportive supervision|Saint Paul Hospital will use team-based models to provide supportive supervision to health centers in its network. Representatives of the supportive supervision teams may, in addition to Saint Paul Hospital employees, include representatives from the Addis Ababa Regional Health Bureau.
16147268|NCT01802957|Other|Midwives exchange program|Saint Paul Millennium Hospital's maternity wards are often over-crowded and have to turn patients away. Health professionals incorrectly refer non-complicated deliveries, resulting in the occupation of beds that should be used for emergency deliveries. This action is attributed to inexperienced midwives at the health center level who are uncomfortable performing normal labor and delivery duties. In order to address this challenge, this project will establish an exchange program in which well-trained, experienced midwives from the hospitals will temporarily exchange places with less-experienced midwives in the health centers. This exchange would allow less-experienced midwives to work in the hospital environment, gaining the experience and confidence necessary to attend normal deliveries and identify appropriate referrals.
16147269|NCT01802957|Other|Strengthening the referral network|Mechanisms and protocols for smooth communication between the health centers and the hospital have been developed, allowing health centers to utilize the hospital's ambulance, and implementing mechanisms for back referrals and feedback. To facilitate this work, we will support the use of dedicated cell phones in each of the eight networked facilities and at Saint Paul Millennium Hospital, and institute referral log books at both the referring and receiving institutions.
16147270|NCT01802957|Other|Facility Checklists|Facility checklists will be used daily in each of the facilities to assess readiness for obstetric emergencies. Formally, the checklists will be used at the quarterly supportive supervision visits, to assess improvements over time.
16147271|NCT01802957|Other|Emergency Drills|Non-punitive obstetric drills will provide multiple measurable indicators of quality maternal care, will illustrate opportunities for improving facility capabilities and provider care, and will allow providers to assess appropriate referral mechanisms and facility readiness. Incorporating emergency drills into current training and at all levels of health facilities will also give providers hands-on experience
16147272|NCT01802944|Drug|Intranasal Insulin|
16147273|NCT01802944|Drug|Placebos|
16147274|NCT01802931|Drug|GSK239512|H3 receptor antagonist, potential victim of drug-drug interaction
16147275|NCT01802931|Drug|ketoconazole|CYP3A4 inhibitor, potential perpetrator of drug-drug interaction
16147276|NCT01802918|Drug|GSK2838232|Bottled powder with 5, 10 and 20mg unit dose strength per single dose for re-constituted oral suspension given once daily
16147277|NCT01802918|Drug|Placebo|Visually matching GSK2838232
16147278|NCT01802918|Drug|Ritonavir|100mg tablets once daily for 12 days
16147279|NCT01802905|Genetic|in depth genomic sequencing|Fresh tumour biopsies and matched normal specimens (blood and surrounding tissue) and when possible archival pretreatment specimens, will undergo in depth DNA and RNA sequencing and analysis on an oncogene panel.
16147280|NCT01802892|Drug|Ronacaleret 100 mg|Subjects in the Ronacaleret 100 mg group received one tablet orally of ronacaleret 100 mg for 5 consecutive days.
16147281|NCT01802892|Drug|Ronacaleret 400 mg|Subjects in the Ronacaleret 400 mg group received four tablets orally of ronacaleret 100 mg daily for 5 consecutive days.
16147282|NCT01802892|Drug|Plerixafor|Subjects in each group received a single dose of plerixafor (0.24mg/kg) SC on the evening of the Day 5 dosing approximately 12 hours before collection of CD34+ cells on day 6.
16147283|NCT01802879|Drug|Panobinostat|Panobinostat was provided as 5, 10 and 20 mg hard gelatin capsules to be taken orally. Patients started on dose from parent protocol and dose modifications were at the discretion of the investigator based on guidance provided in the protocol and IB.
16147284|NCT01802866|Drug|ACU-4429|Take orally once daily for 24 months
16147285|NCT01802866|Drug|Placebo|Take orally once daily for 24 months
16147286|NCT01802853|Drug|RO6811135|Single subcutaneous dose
16147287|NCT01802853|Drug|RO6811135|Single intravenous dose
16147288|NCT01802840|Dietary Supplement|biscuits supplemented with soy fiber|Thirty nine overweight and obese college adults (19-39 y of age) were randomly assigned to consume control biscuits or biscuits supplemented with soy fiber for 12 wk (approximately 100g/d).
16147289|NCT01802814|Drug|SR-A + Epratuzumab|
16147290|NCT01802814|Drug|SR-B + Epratuzumab|
16147291|NCT01802801|Other|embryo development|intra- and inter-observator analysis
16147292|NCT01802788|Device|St Jude Medical Portico replacement aortic valve|
16147293|NCT01802788|Procedure|Transcatheter Aortic Valve Implant|
16147294|NCT01802775|Drug|edoxaban|
16147295|NCT01802775|Drug|Clopidogrel|75mg tablet
16147296|NCT01802775|Drug|Aspirin|
16147297|NCT01802762|Device|NeMo Patch and NeMo Probe|A plaster based patch (NeMo Patch) and a combined probe for ICP monitoring and near infrared spectroscopy (NIRS) are applied as sensors. Data are collected by a NIRS instrument (NeMo Control Unit)
16147298|NCT01802749|Drug|Bevacizumab|
16147299|NCT01802749|Drug|Paclitaxel|
16147300|NCT01802749|Drug|Carboplatin|
16147301|NCT01802749|Drug|pegylated liposomal doxorubicin|
16147302|NCT01802749|Drug|Gemcitabine|
16147303|NCT01802736|Behavioral|Motivational intervention counselling plus SPP|
16147304|NCT01802723|Drug|Drug: salmeterol xinafoate|
16147305|NCT01802723|Drug|Drug: Placebo|
16147306|NCT01802710|Behavioral|Psychological support|
16147307|NCT01802710|Other|No intervention|
16147308|NCT01802697|Drug|IdeS|
16147309|NCT01802697|Drug|Placebo|
16147310|NCT01802684|Biological|aflibercept|Aflibercept (VEGF Trap) Recombinant human protein, at 25 mg/ml Dose : 4 mg/Kg -Day 1, q2w Route of administration: Intravenous (60 min infusion)
16147311|NCT01802671|Other|Rehabilitation treatment and information|Patients will receive the traditional rehabilitation treatment (back school). This treatment will consist of a 4-session group therapy every week, with each session lasting 45 minutes. The content of the first session will be educational (ergonomics, pain demystification) and the other three will include physical therapy focused on stabilisation training: lower extremity stretching; finding the neutral spine position; spine stabiliser activation (transversus abdominis and multifidus); abdominal, spinal extensor and lower extremity strengthening; and proprioceptive control (stabilisation kinesitherapy)
16147312|NCT01802671|Behavioral|cognitive behavioural therapy (CBT)|"Patients will receive the same treatment in physical therapy than the control group and additionally they will receive CBT. The aim of the CBT intervention is to produce changes in the beliefs and behaviors about physical activity and avoidance of activity. The treatment's components are:
~Psychoeducation to counteract the misconceptions about low back pain and to point on the relevance of maintaining an adequate level of activity.
~Cognitive restructuring techniques
~Behavioural therapy and activity pacing
~Training on self-management pain techniques (mindfulness and relaxation). It is a 6-session group therapy, with one session per week. Each group will be composed by 6-8 participants. It will be considered as a patient who receives the treatment when the patient attends to the assessment sessions and to at least 4 out of 6 CBT sessions."
16147313|NCT01802671|Behavioral|cognitive behaviour therapy supported by ICT|The patients of this group will receive the same interventions that the CBT group but will receive a reinforcements of the sessions' content through two different ways, both based on ICTs: a web tool named TEO (Emotional Therapy Online) specially designed to practicing the therapeutic strategies at home; and SMS that will send to the patients' mobile phone with reminders and reinforcements. The content of sessions will be related to the therapeutic components including on the CBT. Patients will access TEO from their home using a personal password. Besides TEO, messages will be sent through SMS three times per week during the treatment and once a week during the follow-up. The messages will consist on reminders to do the homework along with reinforcements of the working and effort made to improve their health.
16147314|NCT01802658|Drug|Zoledronic acid|Zoledronic acid 5 mg. IV. 3 infusions. Administration 3 times inclusion M12 and M24 over two years.
16147315|NCT01802658|Drug|NA Cl|NACl 100 ml IV. 3 infusions. Administration 3 times inclusion M12, M24 over two years.
16147316|NCT01802645|Drug|Cetuximab|
16147317|NCT01802645|Drug|Bevacizumab|
16147318|NCT01802645|Drug|Irinotecan|
16147319|NCT01802645|Drug|Oxaliplatin|
16147320|NCT01802645|Drug|5-FU|
16147321|NCT01802645|Drug|Folinic Acid|
16147322|NCT01802632|Drug|AZD9291|Starting dose 20 mg, administered once daily. If tolerated subsequent cohorts will test increasing doses of AZD9291, until a maximum tolerated dose or maximum feasible dose is defined
16147323|NCT01802619|Other|inhaled nitric oxide|Nitric oxide administration will commence at the onset of CPB and last for 24 hours. At the end of 24 hours, inhaled NO will be weaned and discontinued while carefully monitoring hemodynamics for a period of 2-4 hours.
16147324|NCT01802619|Other|inhaled Nitrogen|Standard gas including nitrogen (the vehicle of the Nitric oxide) administration will commence at the onset of CPB and last for 24 hours. At the end of 24 hours, inhaled gases will be weaned and discontinued while carefully monitoring hemodynamics for a period of 2-4 hours.
16147325|NCT01802593|Drug|AZATHIOPRINE or METHOTREXATE|Patients should continue azathioprine or 6 MP or methotrexate at their previous doses for 6 months IMM therapy 26 weeks
16147326|NCT01802593|Drug|AZATHIOPRINE or METHOTREXATE|"Patients should continue the same dose of azathioprine or 6 MP or methotrexate until the day of the second infusion (week 2)
~Thiopurine therapy 2 weeks"
16147327|NCT01802580|Behavioral|Internet Survey|
16147328|NCT01802580|Drug|fluocinonide 0.05% ointment|
16147329|NCT01802567|Device|Guided Therapy- Pediatric Gene Analysis Platform|A total of 48 neuroblastoma, brain tumor, and rare tumor patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for survival, disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).
16147330|NCT01802554|Behavioral|Pleasant Events Program (PEP)|Behavioral Activation Therapy
16147331|NCT01802554|Behavioral|Information Support (IS)|Information-Support (IS) condition consisted of supportive psychotherapy and informational brochures.
16147333|NCT01802541|Dietary Supplement|triacylglycerol oil|
16147334|NCT01802515|Drug|Atomoxetine, low dose|The effects of 40mg low dose atomoxetine will be compared to placebo and to the 80mg atomoxetine high dose.
16147335|NCT01802515|Drug|Atomoxetine, high dose|The effects of 80mg of high dose atomoxetine will be compared to placebo and to 40mg atomoxetine low dose.
16147336|NCT01802515|Drug|Placebo|The effects of placebo will be compared to the parallel groups of Atomoxetine high (80mg) dose and Atomoxetine low (40mg) dose.
16147337|NCT01802502|Drug|Rifampicin intravenous|
16147338|NCT01802502|Drug|Oral rifampicin|
16147339|NCT01802489|Drug|Amiloride|
16147340|NCT01802489|Drug|Placebo|Placebo capsule identical in appearance to Amiloride 10mg capsule
16147341|NCT01802476|Drug|Oral Drug Formulation of PD-0332991|Treatment A consists of a single 125 mg oral dose of PD-0332991.
16147342|NCT01802476|Drug|Intravenous Formulation of PD-0332991|Treatment B consists of a 1000 mL intravenous infusion of 50 mg of PD-0332991 administered over 4 hours at a constant rate.
16147343|NCT01802450|Drug|Dasatinib|
16147344|NCT01802437|Drug|Fluoxetine|If Hamilton Rating Scale for Depression scores do not meet target reductions (20% reduction for 4-week decision point or 40% reduction for 8-week decision point), adolescents will be further randomized to an increase in therapy (4 extra therapy sessions) or fluoxetine therapy. Adolescents who receive pharmacotherapy will be prescribed fluoxetine for 12 weeks. The dosage schedule will be 10 mg per day for the first week and 20 mg per day for the following 5 weeks. If no treatment response is observed by week 6, the dosage can be increased to 40 mg per day. Pharmacotherapy sessions will be scheduled weekly for the first 4 weeks and every other week thereafter. If no treatment response was observed by the sixth week, the dosage could be increased to 40 mg per day.
16147345|NCT01802437|Behavioral|Increased Dose of Interpersonal Psychotherapy|If Hamilton Rating Scale for Depression scores do not meet target reductions (20% reduction for 4-week decision point or 40% reduction for 8-week decision point), adolescents will be further randomized to an increased dose of interpersonal psychotherapy (4 extra therapy sessions) or fluoxetine.
16147346|NCT01802437|Behavioral|Continue to Receive Initial Dose of Interpersonal Psychotherapy|If Hamilton Rating Scale for Depression scores meet target reductions (20% reduction for 4-week decision point or 40% reduction for 8-week decision point), adolescents will be assigned to continue initial dose of interpersonal psychotherapy.
16147347|NCT01802424|Behavioral|The Friends program|The Friends program is a ten weeks group interventions based on principles from Cognitive Behavioural Therapy aimed at ameliorating symptoms of anxiety and depression in children and adolescents. There are age-specific versions of the manual, one for children 8-12 years and one for adolescents 12-15 years.
16147348|NCT01802411|Drug|EXPAREL 266 mg|
16147349|NCT01802411|Drug|Placebo|
16147350|NCT01802385|Drug|Sertraline|Sertraline 400mg/day for 2 weeks, then 200mg/day for 12 weeks, then tapered over 3 weeks.
16147351|NCT01802372|Behavioral|WHO CVD risk assessment package|Arm#1 (Intervention Group): Provided Ghana's National Health insurance and the WHO CVD Risk Assessment package for 12 months.
16147352|NCT01802372|Behavioral|Health Insurance only|Arm#2 (Control group): Provided Ghana's National Health Insurance for 12 months, brief behavioral counseling at baseline, and usual care.
16147353|NCT01802359|Drug|No intervention|This is an observational study. Korean male participants receiving mirodenafil as per the prescribing information will be observed.
16147354|NCT01802346|Dietary Supplement|dietary intervention|Consume a low-calorie diet
16147355|NCT01802346|Procedure|nutritional support|Receive dietary advice
16147356|NCT01802346|Other|laboratory biomarker analysis|Correlative studies
16147357|NCT01802333|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic transplant
16147358|NCT01802333|Drug|Cytarabine|Given IV
16147359|NCT01802333|Drug|Daunorubicin Hydrochloride|Given IV
16147360|NCT01802333|Drug|Idarubicin|Given IV
16147361|NCT01802333|Other|Laboratory Biomarker Analysis|Correlative studies
16147362|NCT01802333|Drug|Vorinostat|Given PO
16147363|NCT01802320|Drug|Akt Inhibitor MK2206|Given PO
16147364|NCT01802320|Other|Laboratory Biomarker Analysis|Correlative studies
16147365|NCT01802320|Other|Pharmacological Study|Correlative studies
16147366|NCT01802307|Radiation|Brachytherapy|
16147367|NCT01802294|Behavioral|Parenting Program|"Goal of the program is reduction in child behavior problems in high-risk South African families. Program will be delivered to caregivers responsible for the wellbeing of the child.
~Program activities will be delivered over 12 weekly group sessions with additional individualized in-home sessions. The groups (n = 15 participants per group) will meet weekly with community facilitators (n = 2 per group). Parenting skills will be developed during the sessions through role-plays, group-discussion, storytelling, and home practice activities.
~The program is manualized in isiXhosa."
16147368|NCT01802281|Procedure|Uterosacral ligament suspension|The USLS procedure used in this protocol is a modification of the technique described by Shull.
16147369|NCT01802281|Procedure|Uphold® LITE|The Uphold® procedure used in this protocol is a modification of the technique described by Vu and Goldberg.
16147370|NCT01802268|Drug|Conversion from Tacrolimus to Sirolimus|
16147371|NCT01802268|Drug|Maintenance on tacrolimus|
16147372|NCT01802255|Drug|Sevoflurane|Sedation with inhaled anesthetic via AnaConDa.
16147373|NCT01802255|Drug|Midazolam|Intravenous sedation.
16147374|NCT01802242|Radiation|Volumetric Modulated Arc Therapy (VMAT) and High-Dose Rate (HDR) Radiotherapy|"Patients in this group will receive one of 2 treatment arms of their choice:
~Arm 1: VMAT delivery with integrated VMAT boost (IB-VMAT) GTV: 95Gy in 38fractions
~Arm 2: HDR-boost followed by VMAT GTV: 10Gy HDR + 76Gy in 38 fractions VMAT"
16147375|NCT01802242|Other|No Active Treatment - completed Prior Radiation|Already had prior radiation treatment. MRI-guided prostate biopsy at 3 years and PSA per standard practice
16147376|NCT01802229|Procedure|Prophylactic mesh placement|Placement of a Omega 3 mesh, fixed to the border of the fascia
16147377|NCT01802229|Procedure|Fascial suture|The port-site hole is closed with simple suture of the fascia
16147378|NCT01802216|Procedure|Scaling and root planing|non-surgical periodontal disease treatment
16147379|NCT01802216|Drug|Minocycline|antibiotic microspheres
16147380|NCT01802203|Device|truFreeze Spray Cryotherapy|spray cryotherapy
16147381|NCT01802190|Genetic|Deafness patients|SLC17A8 et POU4F3 mutations genes analysis on blood samples of deafness patients.
16147382|NCT01802177|Procedure|UVB excimer light|
16147383|NCT01802164|Device|A non-absorbable composite mesh (Ethicon Physiomesh)|To compare prophylactic mesh implantation to conventional abdominal wall closure in patients undergoing emergency laparotomy for peritonitis.
16147384|NCT01802151|Dietary Supplement|B. subtilis R0179|B. subtilis R0179 for a period of 4 weeks. One capsule per day.
16147385|NCT01802151|Dietary Supplement|Placebo|Placebo (starch, magnesium stearate, citric acid) capsules for a period of 4 weeks. One capsule per day.
16147386|NCT01802138|Biological|Activated T lymphocyte|intravenous dripping of 200 ml (10^9~2*10^10 lymphocytes) for 1 hour.
16147387|NCT01802125|Other|laboratory biomarker analysis|Correlative studies
16147388|NCT01802112|Dietary Supplement|Resistant maltodextrins|15 grams of Resistant maltodextrins per day dissolved in water during 21 days
16147389|NCT01802112|Other|placebo|15gr placebo
16147390|NCT01802099|Other|Enteral nutrition|
16147391|NCT01802099|Other|Parenteral nutrition|
16147392|NCT01802086|Drug|Emla-cream|Topical anaesthetic
16147393|NCT01802086|Drug|Miniderm cream|Topical
16147394|NCT01802073|Drug|Oral Vancomycin|
16147395|NCT01802047|Procedure|milk expression with electric pump|
16147396|NCT01802021|Drug|Astagalus-based Formula: Qingshu-Yiqi-Tang|"Plus astragalus-based formula: Qingshu-Yiqi-Tang 7.2gm BID during 1st line chemotherapy and 2nd line target therapy.
~maximal for 6 months"
16147397|NCT01802008|Procedure|3-minute withdrawal time|"For subjects randomized to the 3-minute withdrawal time, advancement to the cecum will be followed by segmental withdrawal in each of 3 segments of the examined colon. Each segment will be examined over 1 minute, followed by a second look over each segment over 2 minutes by the same endoscopist."
16147398|NCT01802008|Procedure|6-minute withdrawal time|"For subjects randomized to the 6-minute withdrawal, advancement to the cecum will be followed by segmental withdrawal in each of 3 segments of the examined colon. Each segment will be examined over 2 minutes, followed by a second look over each segment over 2 minutes by the same endoscopist."
16147399|NCT01801982|Other|non-interventional|non-interventional
16147400|NCT01801969|Other|Rehabilitation service|"Centralized/ decentralized hospital based rehabilitation defined as hospital based rehabilitation in a single or in multiple locations, respectively.
~Size of the municipality responsible for providing rehabilitation services after discharge from hospital"
16147401|NCT01801956|Behavioral|physical activity|free membership of a sport club
16147402|NCT01801956|Other|Motivational interview|Four motivational interviews by instructors of the local sport club
16147403|NCT01801956|Other|Virtual arena|Uploading of training data from a GPS-watch to a virtual arena
16147404|NCT01801943|Behavioral|Cognitive Remediation Therapy Group|30 min Cognitive Remediation Therapy + 60 Min Healthy Living class 3x week
16147405|NCT01801943|Behavioral|Walking Intervention (WI) Group|60 min Walking Intervention + 30 min low interface reading 3x week
16147406|NCT01801943|Behavioral|Combination Group|30 min Cognitive Remediation Therapy + 60 min Walking Intervention 3x week
16147407|NCT01801943|Behavioral|Healthy Living Group|60 Min Healthy Living class + 30 min low interface reading 3x week
16147408|NCT01801930|Drug|OCV-103 and OCV-104|0.3 mg of each
16147409|NCT01801930|Drug|OCV-103 and OCV-104|1 mg of each
16147410|NCT01801930|Drug|OCV-103 and OCV-104|3 mg of each
16147411|NCT01801930|Drug|OCV-103 and OCV-104|6 mg of each
16147412|NCT01801917|Drug|Placebo|Matching placebo tablet for oral administration
16147413|NCT01801917|Drug|BAF312|BAF312 in 4 dosage strengths in tablet form: 0.25 mg, 0.5 mg, 1 mg, 2 mg for oral administration
16147414|NCT01801904|Drug|Panitumumab|6mg/kg IV given every 2 weeks until disease progression or unacceptable toxicity
16147415|NCT01801891|Device|VASGARD stimulator|The VASGARD device is a 2 channel muscle stimulator system designed for increasing venous blood flow. Controlled electrical stimuli are delivered to the patient through adhesive gel electrodes placed over the motor points of muscles on the lower leg. This elicits artificial muscular contractions which in turn increases lower limb venous haemodynamics.
16147416|NCT01801891|Other|Compression bandaging|Compression bandaging systems apply graduated external pressure to the lower limb to promote venous return to the heart reducing venous hypertension and thereby facilitate venous ulcer healing.
16147417|NCT01801878|Biological|Adipose SVF cell|adipose SVF cell transfer to the half of irradiated breast
16147418|NCT01801878|Biological|Normal saline|Normal saline inject to the half of irradiated breast
16147419|NCT01801865|Device|GE OPTIMA MR430s with HDX/GE Electronics|
16147420|NCT01801852|Biological|NKT cells|
16147421|NCT01801826|Device|Treatment with CryoTouch IV|Bilateral forehead treatment with the Cryo-Touch IV device on the temporal branch of the facial nerve. Subject will be treated once and may have a retreatment up to 7 days after the first treatment
16147422|NCT01801813|Other|Collecting pre-operative, per-operative data, neuro-radiological data and post-operative neuro-surgery complications|
16147423|NCT01801800|Procedure|Echocardiography|Speckle-Tracking of echocardiographic loops by a cardiologist blinded to the patient's management and outcome
16147424|NCT01801787|Device|tDCS|active vs. sham tDCS left hemisphere
16147425|NCT01801774|Drug|Subtenon 20-mg triamcinolone injection|Treatment arm will receive single subtenon 20-mg triamcinolone with gentamicin injection after uneventful phacoemulsification. 0.3% Tobramycin eye drop will be given to treatment arm for 28 days to blind the patient.
16147426|NCT01801774|Drug|Placebo|
16147427|NCT01801748|Dietary Supplement|oral wheat challenge|
16147428|NCT01801735|Drug|Meloxicam Test Capsules|
16147429|NCT01801709|Genetic|intracerebral administration of AAVrh.10cuARSA|
16147430|NCT01801696|Other|Parent massage tx group|The parent-delivered massage is based on Chinese medicine. There are specific techniques for each area of difficulty, e.g. the head, fingers, and toes. After a few months, massage becomes relaxing and enjoyable, and parent touch comes back into use to effectively help the child self-regulate.
16147506|NCT01800903|Device|ZN-C catheter|ZN-C catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
16147507|NCT01800903|Device|SpeediCath catheter|The Speedicath cathere is CE-marked and commercially available.
16147431|NCT01801696|Other|Parent massage wait-list control group|The parent-delivered massage is based on Chinese medicine. There are specific techniques for each area of difficulty, e.g. the head, fingers, and toes. After a few months, massage becomes relaxing and enjoyable, and parent touch comes back into use to effectively help the child self-regulate.
16147432|NCT01801683|Other|Intervention-using PEARLS|The intervention applied in this study was the modified academic detailing method, performed by sixth-year medical students as academic detailers. The students qualified for that role because they were taught about EBM in several courses during their undergraduate curriculum. During the family medicine rotation, each GP mentored six students in total. In Split each student visited two mentors for two weeks. In the course of rotation each mentor chose two patients (cases) from real life who represented diagnostic, therapeutic or prognostic challenge. The students' task was to form an answerable question, using the Patient, Intervention, Comparison, Outcome (PICO) scheme, find the best evidence-based answer to that question and to write a brief report according to Practical Evidence about Real Life Situations (PEARLS) pattern. The mentor then reviewed the report and discussed it with the student.
16147433|NCT01801670|Procedure|Biopsy|Two 6 mm skin punch biopsies (one from pruritic skin and from involved non pruritic skin).
16147434|NCT01801670|Procedure|Blood|Peripheral blood (10 mls) to be drawn and used for cytokine analysis.
16147435|NCT01801644|Drug|gemcitabine plus cisplatin|gemcitabine 1000 mg/m2 on days 1,8,15 as a 30 minute infusion followed by cisplatin 70 mg/m2 on day 1 as an 2 hour infusion
16147436|NCT01801631|Other|Home visits|In addition to usual care the patients will receive three home visits from a trained diabetes nurse. The first visit (65 minutes) is within three weeks after discharge from the hospital; the second visit (45 minutes) is two weeks later and the third visit (45 minutes) is two months after the second home visit.
16147437|NCT01801631|Other|Consultation by telephone|In addition to usual care patients will receive a consultation by telephone within three weeks after discharge to offer them personal attention. In this consultation they will get the opportunity to discuss in ten to fifteen minutes how they feel in the period after discharge.
16147438|NCT01801605|Procedure|rTMS|Active session with stimulation and placebo session with fictive stimulation
16147439|NCT01801566|Procedure|Single implant-retained mandibular overdenture|60 patients treated with single implant retained complete mandibular denture (overdenture) opposed to a conventional maxillary denture, allocated into 2 experimental groups according to the implant loading protocol (conventional and immediate), evaluated at baseline and after 1, 3, 6 and 12 months after treatment.
16147440|NCT01801553|Other|Spinal manipulation|"-In the intervention group :
~True Lumbopelvic manipulation in supine (A) or in lateral side lying (B) for subjects with LBP:
~If for example, A is the best position for both patient-practitioner but after a maximum of two trials doesn't produce a pop sound then the practitioner will move to the B position for a maximum of two trials as well.
~-In the control group:
~Sham spinal manipulation will realize to mimic (i) the same time, (ii) interaction and (iii) action with the manual therapist but without any efficacy in the position B using the upper body of the patient to target the thoraco-lumbar hinge and not the lumbopelvic region and take the time of handling the patient like in a true SM and mimic a high velocity and short ROM action moving fast his body but with a minimal action on the patient's body."
16147441|NCT01801553|Other|sham spinal manipulation|
16147442|NCT01801553|Other|Usual medical care|
16147443|NCT01801540|Dietary Supplement|L-arabinose - effect on glucose metabolism|L-arabinose is mixed into the dough of the buns and cup cakes
16147444|NCT01801527|Behavioral|Telerehabilitation group|Interventions will be based on to provide cardiovascular, mobility, strength and stretching exercises through telerehabilitation system
16147445|NCT01801514|Device|Computed Tomography scan|Routine Computed Tomography scan
16147446|NCT01801475|Drug|Ondansetron|Pregnant & non-pregnant women will receive either 4mg or 8mg of Ondansetron (IV) once prior to surgical procedure (open-label). Women are in the study for 8 hours. Babies of pregnant women are not given Ondansetron but are in the study for 24-48 hours.
16147447|NCT01801462|Other|Simulation-based training|
16147448|NCT01801449|Drug|Rilonacept|
16147449|NCT01801436|Drug|Bortezomib|Bortezomib 1.3 mg per (m^2) on Days 1, 4, 8, and 11 of each 3-week cycle for up to 8 cycles.
16147450|NCT01801423|Drug|Hydroxyurea|Hydroxyurea will be prescribed as an investigational therapy by the treating physician. Recommended guidelines for titration of hydroxyurea to maximal tolerated dose are below. The study intervention will include hydroxyurea to begin at ~20 mg/kg/day (range 17.5 - 26 mg/kg/day). No dose escalation will occur as this dose was shown to have some efficacy in infants with SCA and was associated with rare myelosuppression.(1)
16147451|NCT01801410|Device|Foley Catheter|Transcervical Foley catheter (silicone, size 18F with 30ml balloon)
16147452|NCT01801410|Drug|Misoprostol|25mcg every 2 hours for maximum of 12 doses
16147453|NCT01801397|Drug|osteoanabolic therapy|
16147454|NCT01801384|Behavioral|Voucher-based incentives|
16147455|NCT01801371|Drug|68Ga-BNOTA-PRGD2|Single intravenous bolus injection of nearly 111 MBq 68Ga-BNOTA-PRGD2 at 30 minutes before brain PET/CT scanning.
16147456|NCT01801358|Drug|AEB071|Twice-daily doses of AEB071 for a cycle of 28-days, given without interruption (continuous cycles)
16147457|NCT01801358|Drug|MEK162|Twice-daily doses of MEK162 for a cycle of 28-days, given without interruption (continuous cycles)
16147458|NCT01801345|Other|Fatigued|
16147459|NCT01801345|Other|Rested|
16147460|NCT01801332|Dietary Supplement|intensive nutrition|"Patients randomized in  intensive enteral nutrition  arm will receive by feeding tube (with the use of a microsonde), and in continuous administration, 2 liters of Fresubin HP Energy (1500 kcal/liter, 75 gr prot/liter) for patients with a weight of more than 90 kgs (after ascites removal), 1.5 liters of Fresubin HP Energy for patients with a weight between 60 and 90 kgs, and 1 liter of Fresubin HP Energy for patients of less than 60 kgs. Patients with significant encephalopathy despite therapy against encephalopathy will receive Fresubin Hepa in place of Fresubin HP Energy (1300 kcal/liter, 40 gr prot/liter, 44 % branched AA). Duration of enteral nutrition by feeding tube will be 14 days. The adaptation to the targeted volume must be achieved in maximum 3 days. Enteral nutrition will be administered by nasogastric microsonde."
16147508|NCT01800890|Device|Coloplast A|Coloplast A is a newly developed 2-piece ostomy appliance
16147509|NCT01800890|Device|Coloplast B|Coloplast B is a newly developed 2-piece ostomy appliance
16147623|NCT01800045|Drug|Placebo|1 capsule in the morning before breakfast
16147461|NCT01801332|Dietary Supplement|usual meals|"Patients randomized in  classical oral nutrition  arm (control arm) will receive usual meals (estimated at 1750 kcal/day; 70 g protein/day), and alimentary supplements between meals to achieve the ESPEN recommandations (35-40 kcal/kg/day; protein 1.2-1.5 g/kg/day) (Plauth et al, Clinical Nutrition 2006). Calories and proteins intake must be recorded daily."
16147462|NCT01801319|Device|Libra Deep Brain Stimulation System|
16147463|NCT01801306|Device|NeMo Probe|A new minimal-invasive brain tissue probe applying near infrared spectroscopy
16147464|NCT01801293|Drug|GS-5806|
16147465|NCT01801280|Drug|Mycophenolate sodium|Daily dose: 720mg, 1080mg, 1440mg. Application alone or together with Pantozol®.
16147466|NCT01801280|Drug|Pantoprazole|Daily dose: 40mg. Application together with CellCept® or Myfortic® .
16147467|NCT01801280|Drug|Mycophenolate mofetil|Daily dose: 1000mg, 1500mg, 2000mg. Application alone or with Pantozol® .
16147468|NCT01801267|Procedure|Endoscopic third ventriculostomy (ETV)|Pediatric patients in need of CSF-diversion surgery will undergo an endoscopic third ventriculostomy (ETV). A neurosurgeon will make a small hole in the third ventricle (a fluid space in the brain) to allow CSF to flow out of the ventricles.
16147469|NCT01801267|Procedure|Ventricular shunt|Pediatric patients in need of CSF-diversion surgery will undergo ventricular shunt placement or revision. A neurosurgeon will insert a small tube into the ventricle (a fluid space in the brain) and connect this tube to another location in the body so that CSF can flow out of the brain and be absorbed elsewhere in the body - the belly, the top of the heart or the side of the lung. If a patient already has a shunt which is not working, a neurosurgeon will fix or replace it. This will serve as the Control arm of the study.
16147470|NCT01801254|Other|STRIDES|Self-Control TRaining for Increasing Delay of gratification through EEG operant conditioning with Source localization (STRIDES). Brain-computer interface training protocol designed to up-regulate specific types of neural activity, in regions including the left dorsolateral prefrontal cortex, the anterior cingulate cortex, and Brodmann area 6 bilaterally. Targeted neural activity types are positively associated with self-controlled behavior.
16147471|NCT01801254|Other|Sham Control|Brain-computer interface training protocol that is designed to have no effect on self-controlled behavior.
16147472|NCT01801228|Drug|Eplerenone|
16147473|NCT01801202|Device|LightSheer Duet HS handpiece|The approach to be studied here relies on a cleared modality, the LightSheer Duet High Speed (HS) that uses 805 nm diode laser with vacuum (K053628).
16147474|NCT01801189|Drug|Pregabalin|One 300 mg oral dose of Pregabalin given before surgery.
16147475|NCT01801189|Drug|Placebo (for Pregabalin)|One oral dose of placebo given before surgery.
16147476|NCT01801176|Other|MRI|MRI every 3 months during the first year and then every 6 months during the second year and then one MRI up to 36 months
16147477|NCT01801163|Drug|Sorafenib|Sorafenib x 2 weeks followed by Stereotactic Radiotherapy and then sorafenib until disease progression.
16147478|NCT01801163|Radiation|Stereotactic radiotherapy|Sorafenib x 2 weeks followed by Stereotactic Radiotherapy then Sorafenib until disease progression.
16147479|NCT01801150|Device|CPAP nasal treatment|Treatment with titred CPAP nasal during the nighttime
16147480|NCT01801137|Drug|Everolimus (Afinitor®)|
16147481|NCT01801124|Drug|EXPAREL|single dose 266 mg of undiluted EXPAREL
16147482|NCT01801111|Drug|Erlotinib|Erlotinib will be administered at a dose of 100 mg via tablet, orally, once daily in combination with alectinib to participants who progressed on alectinib alone treatment as per treating physician discretion.
16147483|NCT01801111|Drug|Alectinib|Alectinib will be administered at a dose of 600 milligrams (mg) via capsule, orally, twice daily.
16147484|NCT01801072|Drug|Levetiracetam|Details covered in Arm Descriptions.
16147485|NCT01801059|Other|educational intervention|Receive patient activation intervention by educational video and brochure
16147486|NCT01801059|Other|educational intervention|Receive patient activation intervention by educational video
16147487|NCT01801059|Other|questionnaire administration|Ancillary studies
16147488|NCT01801046|Drug|mitoxantrone hydrochloride|Given IV
16147489|NCT01801046|Drug|cytarabine|Given IV
16147490|NCT01801046|Procedure|peripheral blood stem cell transplantation|Undergo HMMACT with G-PBSC
16147491|NCT01801046|Other|laboratory biomarker analysis|Correlative studies
16147492|NCT01801020|Other|temperature measuremts|temporal artery temperature measurements will be taken from the forehead
16147493|NCT01801020|Other|temperature measuremts|different modes of temperature measuremts will be compared to one another in the same patient. if temporal measurement is higher than oral a rectal temperature will be taken
16147494|NCT01801007|Device|Flow Re-Direction Endoluminal Device (FRED)|
16147495|NCT01800968|Drug|Liraglutide|Active Drug
16147496|NCT01800968|Drug|Placebo|Placebo
16147497|NCT01800955|Device|resistive capacitive diathermy treatment (resistive capacitive diathermy, Hcr 902, Unibell)|The resistive capacitive diathermy is a medical device supplying low (448 KHz) radiofrequencies with maximum output power of 200 W. It is used to reduce pain and inflammation and allowing healing processes. diathermy treatment is administered for a thirty minutes session, three times per week for a total of ten sessions.
16147498|NCT01800955|Other|sham placebo resistive capacitive diathermy treatment|"The sham treatment is administered with the diathermy device set on on but not active (not supplying energy) and the treatment session has the same modalities, frequency and duration of experimental diathermy group"
16147499|NCT01800942|Drug|Azithromycin and Placebo|A single oral dose of 2g of Azithromycin will be given to the women in labour
16147500|NCT01800929|Device|N6|Children with N5 will be upgraded to the N6 for a period of up to 2 months to evaluate.
16147501|NCT01800916|Device|Coloplast Adhesive baseplate A|Coloplast Adhesive baseplate A is a newly developed 1-piece ostomy appliance.
16147502|NCT01800916|Device|Coloplast Adhesive baseplate B|Coloplast Adhesive baseplate B is a newly developed 1-piece ostomy appliance
16147503|NCT01800916|Device|Coloplast Adhesive baseplate C|Coloplast Adhesive baseplate C is a newly developed 1-piece ostomy appliance
16147504|NCT01800916|Device|SenSura 1-Piece|SenSura 1-piece is the commercial CE-marked Coloplast 1-piece SenSura .
16147505|NCT01800903|Device|ZN-D catheter|ZN-D catheter is a catheter, similar to the CE-marked SpeediCath, but with a newly developed coating.
16147510|NCT01800890|Device|Coloplast C|Coloplast C is a newly developed 2-piece ostomy appliance
16147511|NCT01800890|Device|SenSura Click|The comparator product is the commercial and CE-marked SenSura Click (2-piece) manufactured by Coloplast A/S.
16147512|NCT01800877|Drug|Vasopressors|
16147513|NCT01800864|Other|obesity|
16147514|NCT01800851|Other|Energy expenditure evaluation in calorimetric chamber|
16147515|NCT01800838|Drug|silicon phthalocyanine 4|Given topically
16147516|NCT01800838|Drug|photodynamic therapy|Undergo PDT
16147517|NCT01800838|Other|pharmacological study|Correlative studies
16147518|NCT01800838|Other|laboratory biomarker analysis|Correlative studies
16147519|NCT01800825|Drug|Clindamycin|Clindamycin 300 mg Orally will be administered twice daily for a total of 5 days
16147520|NCT01800825|Drug|Placebo|This will be an identical placebo comparator made of starch.
16147521|NCT01800812|Biological|Injections of OM-174|
16147522|NCT01800799|Drug|Baktar 800mg h.s.|Antimicrobial agent (Baktar 800mg h.s.)
16147523|NCT01800799|Drug|Celecoxib 200mg QD|Anti-inflammatory agent (Celecoxib 200mg QD)
16147524|NCT01800786|Device|CPAP|
16147525|NCT01800773|Behavioral|Written Exposure Therapy|Written exposure therapy is a 5 session, weekly treatment in which individuals write about their trauma event in a specified manner.
16147526|NCT01800773|Behavioral|Cognitive Processing Therapy|Cognitive Processing Therapy (CPT) is an evidence-based treatment for PTSD. CPT consists of 12, weekly sessions.
16147527|NCT01800760|Dietary Supplement|Probiotics|Probiotics once a day for three weeks.
16147528|NCT01800747|Other|Antibiotic prescription strategies|The patients enrolled will be randomized between three treatment strategies or arms. Patients randomized to delayed treatment arm or direct treatment, doctors can choose the antibiotic that they consider appropriate depending on such local resistance or practice.
16147529|NCT01800734|Other|Clamp-Mixed Meal Arm|"Standard clinical parameters will be assessed in all patients.
~Metabolic tests:
~A. Euglycemic insulin clamp. A standard euglycemic insulin clamp will be carried out to assess insulin sensitivity, as previously described (1).
~B. Mixed meal test. All participants will ingest a standardized mixed meal and will be monitored for 300 minutes thereafter. Right before meal ingestion, a s.c. fast insulin analogue bolus will be administered by the pump
~This test will determine the time courses of:
~1. plasma glucose, 2.13C/12C glucose ratio (hence, meal-derived and endogenous glucose), 3. insulin, 4. free fatty acids, 5. aminoacids, 6. glucagon, 7. incretin hormones 8. glucose control coefficients (CCs) during a mixed meal."
16147530|NCT01800721|Behavioral|SNAP|Behavioral: SNAP 7 group sessions, and 1 individual session
16147531|NCT01800721|Behavioral|SNAP Control|Behavioral: SNAP control 7 group sessions
16147532|NCT01800708|Drug|Triamcinolone acetonide|
16147533|NCT01800708|Drug|Prednisolone syrup|
16147534|NCT01800695|Drug|ABT-414|ABT-414 will be administered by intravenous infusion
16147535|NCT01800695|Drug|Temozolomide|Temozolomide will be administered per label and local prescribing regulations.
16147536|NCT01800695|Radiation|Whole Brain Radiation|Whole Brain radiation will be administered in 30 fractions.
16147537|NCT01800682|Drug|Tramodol Extended-Release (ER)|Tramodol ER, will be administered orally as either 25, 50 or 100 milligram tablet, once daily on Day 1 of each treatment period (separated with washout period of 4-14 days).
16147538|NCT01800669|Other|CHICA MLP Module|The MLP module screens families for medical-legal issues, alerts the physician to there presences and provides guidance and referral materials to help the physician resolve the issues.
16147539|NCT01800669|Other|CHICA without the MLP module|Clinics in the control group will have the CHICA system, but without the MLP module. It will screen for medical-legal issues but will not provide additional guidance and referrals to help resolve them.
16147540|NCT01800656|Procedure|"Endoloop-assisted ligate and let go colorectal polypectomy"|The technique implies placement of endoloop snare on the base of large pedunculated colorectal polyps without consecutive snare polypectomy.
16147541|NCT01800656|Procedure|Endoloop-assisted snare colorectal polypectomy|The technique implies placement of endoloop snare on the base of large pedunculated colorectal polyps with consecutive snare polypectomy.
16147542|NCT01800643|Other|Analyze the pharmacokinetics of busulfan for transplantation|"Evaluate the Bu pharmacokinetics (PK) when the drug will be received by P.O or I.V and we will establish the target Area Under Curve- AUC based on a single daily dose (test dose) before HSCT. The test dose of orally Bu is 1 mg/Kg and the blood samples are collected and processed in time: 0h, 30 min, 1h, 1,5h, 2h, 3h, 4h, 5h and 6h after drug intake. After extraction of the plasma samples busulfan, quantitative analyzes of busulfan on human plasma will be performed by the liquid chromatograph. For the patients that will receive intravenously busulfan, the test dose is 32 mg/m2 and blood samples are collected in time: 0h, 30', 45', 1h, 2h, 3h, 4h, 5h, 6h and 8h after drug intake. The dose during the conditioning will depend on the test dose and the AUC target."
16147543|NCT01800630|Drug|Gemcitabine HCl Oral Formulation|
16147544|NCT01800617|Drug|Liothyronine, Sodium|
16147545|NCT01800604|Behavioral|Pain Self-Management Intervention #1|Pain Self-Management Intervention #1 will consist of four 60-minute sessions conducted in person over four weeks (1 session/week on average), scheduled at times convenient for participants (including evenings and weekends if necessary). The sessions will cover a variety of topics, including the definition of chronic pain, the physiological processes underlying chronic pain, common pain-related conditions such as sleep disturbance, and the effects of chronic pain. Participants will be encouraged to ask questions about and discuss the information presented during the treatment sessions.
16147546|NCT01800604|Behavioral|Pain Self-Management Intervention #2|Pain Self-Management Intervention #2 will consist of four 60-minute sessions conducted in person over four weeks (1 session/week on average), scheduled at times convenient for participants (including evenings and weekends if necessary). Pain Self-Management Intervention #2 will emphasize cognitive restructuring skills to replace maladaptive pain-related thoughts with adaptive and reassuring ones. These skills include being able to: (1) develop awareness of one's thoughts; (2) identify and evaluate adaptive/helpful vs. unhelpful/maladaptive thoughts; and (3) develop alternative thoughts to maladaptive thoughts that are (a) realistic, (b) accurate, (c) reassuring, and (d) facilitate positive outcomes.
16147619|NCT01800097|Drug|placebo|Tablets, 400 mg once daily ( 200 mg if age 65 or above)morning for 3 months.
16147624|NCT01800019|Drug|Nicotine Replacement Therapy (NRT)|
16147547|NCT01800604|Behavioral|Pain Self-Management Intervention #3|"Pain Self-Management Intervention #3 will consist of four 60-minute sessions conducted in person over four weeks (1 session/week on average), scheduled at times convenient for participants (including evenings and weekends if necessary). In Pain Self-Management Intervention #3, subjects will relax in a comfortable position with their eyes closed and simply listen to the clinician speak. The clinician will begin the session with a hypnotic induction focusing on being aware of sensations of relaxation, followed by suggestions for decreases in pain intensity and alterations in the sensory experience of what are sometimes uncomfortable sensations so that they are more comfortable."
16147548|NCT01800604|Behavioral|Pain Self-Management Intervention #4|Pain Self-Management Intervention #4 will consist of four 60-minute sessions conducted in person over four weeks (1 session/week on average), scheduled at times convenient for participants (including evenings and weekends if necessary). Pain Self-Management Intervention #4 will use hypnotic strategies and suggestions for identifying adaptive cognitions and for making adaptive changes in cognitions more integrated into a participant's belief system.
16147549|NCT01800591|Behavioral|Financial incentive|
16147550|NCT01800578|Device|monitor for depth of hypnosis|"evaluation of depth of hypnosis
~--------------------------------------------------------------------------------"
16147551|NCT01800565|Other|Measurement of LH in first-voided urine|participants in this study will be studied by the standard GnRH stimulation test. In addition, they will provide first voided urine sample (the experimental part)for the measurement of LH.
16147552|NCT01800565|Other|collection of first-voided urine sample for LH level|participants in this study will be studied by the standard GnRH stimulation test. In addition, they will provide first voided urine sample (the experimental part)for the measurement of LH.
16147553|NCT01800552|Procedure|Intentional infiltration of a peripheral IV site|An intentional infiltration of isotonic saline solution is performed by pushing the needle through the vein wall into the subcutaneous tissue. A total volume less than or equal to 5 cc of saline is infiltrated into the tissue.
16147554|NCT01800539|Behavioral|Provider Education Model (PEM)|Providers will be trained to use evidence-based practices for early intervention service delivery in the Autism Spectrum Disorder population.
16147555|NCT01800526|Drug|N-Acetylcysteine|Oral and Intravenous administration of NAC
16147556|NCT01800513|Procedure|Endometrial Biopsy|
16147557|NCT01800513|Procedure|Sham Procedure|
16147558|NCT01800500|Behavioral|smoking cessation intervention|Purchase ST products using a fixed rate of product prices
16147559|NCT01800500|Behavioral|smoking cessation intervention|Purchase ST products using escalating product prices
16147560|NCT01800500|Other|questionnaire administration|Ancillary studies
16147561|NCT01800500|Other|quality-of-life assessment|Ancillary studies
16147562|NCT01800500|Other|laboratory biomarker analysis|Correlative studies
16147563|NCT01800500|Other|ecigarettes|Purchase ST products using escalating product prices nicotine replacement therapy
16147564|NCT01800500|Other|ecigarettes|Purchase ST products using a fixed rate of product prices nicotine replacement therapy
16147565|NCT01800487|Drug|silymarin|140 mg three times a day for 4 weeks
16147566|NCT01800487|Drug|Placebo|Placebo (silymarin) 1 tab three times a day for 4 weeks
16147567|NCT01800461|Other|OPC-Stroke|Occupational therapy coaching intervention
16147568|NCT01800461|Other|Usual care|Usual community care
16147569|NCT01800435|Drug|aPCC, aPCC + TXA|Feiba 75 IU/kg i.v Feiba 75 IU/kg i.v +Cyklokapron 20 mg/kg p.o
16147570|NCT01800435|Drug|rFVIIa, rFVIIa + TXA|NovoSeven 90 µg/kg i.v NovoSeven 90 µg/kg i.v + Cyklokapron 20 mg/kg
16147571|NCT01800422|Drug|telapristone acetate|Given orally
16147572|NCT01800422|Other|placebo|Given orally
16147573|NCT01800422|Procedure|therapeutic conventional surgery|Undergo surgical resection
16147574|NCT01800422|Other|laboratory biomarker analysis|Correlative studies
16147575|NCT01800422|Other|questionnaire administration|Ancillary studies
16147576|NCT01800409|Device|AFES|During the stimulation sessions electrical stimulation will be applied for 40 minutes per day, 5 days per week for a total of 8 weeks
16147577|NCT01800396|Dietary Supplement|Milk protein|
16147578|NCT01800396|Dietary Supplement|Milk protein rich in phospholipids|
16147579|NCT01800370|Drug|Hyperglycemia|Hyperglycemia (rest controlled) will be induced by i.v. injection of 25 mL of dextrose 50% over 3 minutes with the subject supine.
16147580|NCT01800370|Drug|Saline|Saline (rest controlled) will be induced by i.v. injection of 25 mL of saline over 3 minutes with the subject supine.
16147581|NCT01800370|Other|Exercise|"Monitored exercise of 7-minute biking, 2-minute arm weights and a blood draw at the 10-minute time point will be repeated 3 times,which takes 30 minutes.
~Bilateral arm curls begin at 20 pounds and decrease by 5 pounds as needed to sustain 2 minutes of exercise at a rate of 1 complete curl every 2 seconds."
16147582|NCT01800370|Procedure|Blood Draws|Blood will be sampled every 10 min from 0700 to 1300 h. Each intervention will begin at 0800 h after 1 h of baseline sampling, and be completed by 0900 h. Intervention is followed by 4 additional h of sampling to capture recovery (total sampling 6 h). Ten-min samples are for Te, LH, ACTH, cortisol, and GH. Glucose will be checked every 30 min. At 07000 h an archival serum sample will be obtained for safety-monitoring purposes.
16147583|NCT01800370|Other|Fasting procedure|Beginning at 1900 h on the evening prior to each study visit, subjects will remain fasting except for water, diet soda, and other non-caloric and non-caffeinated fluids, until 1300 h the next day.
16147584|NCT01800357|Drug|infusion of mildronate|infusion of mildronate(500mg) once a day and for 14 days
16147585|NCT01800357|Drug|placebo|infusion of plabcebo once a day and for 14 days
16147586|NCT01800357|Drug|aspirin|infusion of aspirin (100mg) once a day for days
16147587|NCT01800344|Device|LMA|
16147588|NCT01800344|Device|Ultra|Ultra
16147589|NCT01800331|Behavioral|Text2bHealthy|The intervention group uses handheld computers to keep track of their lifestyle behaviours and they will receive feedback on thier progress and tips (Text2bHealthy)
16147620|NCT01800084|Device|Asir Image Acquisition|In addition to their normal image acquisition, a supplementary image acquisition lasting approximately 20 seconds (i.e. an ASIR image acquisition) will be carried out for each patient.
16147621|NCT01800071|Drug|MVA-EBNA1/LMP2 vaccine|
16147622|NCT01800045|Drug|Pitolisant|1 capsule in the morning before breakfast
16147590|NCT01800318|Device|NESAP|Electrical stimulation will be administered via the Empi Select, a standard TENS unit. To produce analgesia, small electrodes will be placed in treatment groups on the baby's legs at specific acupuncture points: ZuSanLi (ST36), SanYinJiao (SP6), Shen Mai (Bl60), and Shui Quan (KI3)46. StimCare electrodes with a gel base will be applied to the skin ; the skin will not be punctured by these procedures. A low continuous current will be provided with minimal voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 2 minutes after the heel stick. The display will be hidden from view to prevent the rater from being able to observe whether the unit is on.
16147591|NCT01800318|Behavioral|24% oral Sucrose|One ml 24% sucrose will be given approximately two minutes before the heel stick. Sucrose will be given via oral syringe along with a pacifier.
16147592|NCT01800318|Device|Sham NESAP|Four electrodes will be placed on the infant's lower leg, but the TENS unit will not be turned on. The TENS unit will be covered and investigators will not know whether the TENS unit is turned on or not (sham NESAP).
16147593|NCT01800318|Behavioral|Oral water|For infants in the control group, 1 ml of water will be given via oral syringe along with a pacifier 2 minutes before the heel stick. Investigators will be blinded on whether the infants are receiving water or oral sucrose.
16147594|NCT01800305|Drug|Pegylated rhEPO|
16147595|NCT01800305|Drug|EPIAO®|
16147596|NCT01800292|Drug|sildenafil|Subjects will be started on sildenafil at 20 mg PO TID at the baseline visit. Each individual will serve as his/her own control. Subjects will be evaluated at 3 months, with participation completed at that time.
16147597|NCT01800279|Other|Physiotherapy Protocol|"Kinesitherapy
~Patient: supine position on the stretcher with a loop of 6 cm in the cervical area.
~Tongue in the palate for all applied exercises.
~Repetitions of each exercise: 8. Cervical traction. Cranium fore flexion 15 °. Open-close mouth dental contactless (10mm). Opening movement with a small resistor (one finger on chin).
~Flexion of the head, without actually lifting, resisting in the front. Occipital extension. Cranium fore flexion 15 °. Cervical traction.
~Myofascial Therapy. Induction suboccipital. Compression - decompression of the TMJ (Temporomandibular Joint). Horizontal Induction TMJ. Deep fascia induction in the temporal region. Deep Induction of the masseter fascia. Deep Induction of the external pterygoid. Induction of intraoral pterygoid."
16147598|NCT01800279|Other|Deontology Therapy|"For the realization of the splint, the following protocol will be developed at the Faculty of Dentistry of Granada (Spain):
~Impression of the maxilla with chromatic alginate Phase plus (Zhermack ©, Rovigo, Italy).
~Emptying working models in plaster-stone type IV Elite Rock (Zhermack ©, Rovigo, Italy).
~Deprogramming occlusal splints were made of polyester plates with terephthalic acid of 3 mm thick Clear 120 model (Dentaflux ©, Ripoll, Madrid). We used a molding machine of thermoplastic vacuum plate The Machine Dentaflux ©, Ripoll, Madrid."
16147599|NCT01800266|Behavioral|Supervision Practices of TF-CBT|Supervisors will be trained in one of two supervision strategies: Symptom and Fidelity Monitoring (SFM) or Symptom and Fidelity Monitoring + Behavioral Rehearsal (SFM + BR)
16147600|NCT01800253|Behavioral|Inhibitory task|Participants perform a binary decision on each presented stimuli. Of the two possible outcomes, participants are instructed to make a motor response (go) for one type, and are to withhold a response (no-go) for the other type. Reaction time and accuracy are measured for each event
16147601|NCT01800253|Procedure|Blood samples|Hormone levels, neuromolecular levels and gene expression profiles will be analyzed from repeated blood samples obtained before and after the nighttime intervention
16147602|NCT01800253|Procedure|Tissue samples|Expression profiles will be analyzed from samples obtained from tissues involved in metabolism
16147603|NCT01800253|Procedure|Oral glucose tolerance test|75 g of glucose will be dissolved in 300 ml of water and given to participants, followed by blood sampling at 0, 15, 30, 60, 90, 120 and 150 minutes following the ingestion of the glucose solution.
16147604|NCT01800253|Behavioral|Portion Size Task|Participants are given a computer program that gives them the opportunity to choose the portions of a variety of food items that they would ideally like to consume
16147605|NCT01800240|Drug|Torrent's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets|
16147606|NCT01800227|Drug|Torrent's Pioglitazone Hydrochloride and Metformin Hydrochloride Tablets|
16147607|NCT01800201|Behavioral|Electronic Pill Bottle, Incentives, Social Influence|The intervention group (1) will use GlowCaps, a remote monitoring and reminder pill bottle; (2) assigned an engagement advisor from the study team; (3) asked to provide study team with names and contact information of up to 3 family members or friends as support partners for med adherence. The study team will contact these people in order listed until 1 agrees to this role; (4) will select a 2-digit lucky number to be used as part of the sweepstakes-based engagement incentives in which eligibility to win will be conditional on med adherence; and (5) will determine preferences for Way to Health platform communication methods.The group receiving the program intervention will also have their claims data analyzed for the 12 months post-enrollment.
16147608|NCT01800188|Procedure|Hemodialysis|A 4 hour hemodialysis with a standardized liquid meal after one hour
16147609|NCT01800188|Procedure|Hemodiafiltration|A 4 hour hemodiafiltration with a standardized liquid meal after one hour
16147610|NCT01800188|Procedure|Meal test|A 3 hour standardized liquid meal test without dialysis
16147611|NCT01800175|Device|Punctum Plug|
16147612|NCT01800162|Drug|Methotrexate|Two Dose Protocol: The patient will receive the first dose of MTX 50mg/m2 on treatment day 0. She will receive a second dose of MTX 50mg/m2 on treatment day 4 and a serum hCG level will be drawn. Subsequent doses of MTX will be administered based on hCG levels.
16147613|NCT01800162|Procedure|Uterine Evacuation|Uterine evacuation or dilation and curettage. At the clinician's discretion, this can be performed using local anesthesia, sedation or general anesthesia and can use a manual or electrical evacuation.
16147614|NCT01800162|Other|Expectant Management|Pregnancy will be expectantly managed using serum hcg monitoring.
16147615|NCT01800149|Procedure|Ridge Augmentation|After tooth extraction, the sockets will be filled with bovine bone mineral and covered with a porcine collagen membrane
16147616|NCT01800136|Device|Repetitive Transcranial Magnetic Stimulation and Transcranial Direct Current Stimulation|Five sessions of HF-rTMS or tDCS applied daily during 5 consecutive days
16147617|NCT01800110|Dietary Supplement|pomegranate juice|
16147618|NCT01800097|Drug|modafinil|Tablet, 400 mg once daily, morning (200 mg if age 65 or above) for 3 months
16147625|NCT01800019|Drug|Varenicline|
16147626|NCT01800019|Behavioral|HIV Tailored Quit Smoking Counseling|"A cognitive behavioral therapy (CBT) oriented smoking cessation program tailored to HIV positive individuals.
~People Living with HIV/AIDS (PHA) tailored Canadian HIV Quit Smoking Counseling Intervention. It consists of face-to-face counseling sessions with a trained smoking cessation counsellor at randomization, on the identified quit date, and then at weeks 4, 8, 12, and 24."
16147627|NCT01800006|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Patients with non-valvular atrial fibrillation who are prescribed Rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism. Decision regarding dose and duration of treatment made at the discretion of the attending investigator.
16147628|NCT01799993|Drug|Amikacin Inhalation Solution (BAY41-6551)|400 mg of aerosolized amikacin every 12 hours for 10 days to be administered using the Pulmonary Drug Delivery System (PDDS Clinical)
16147629|NCT01799993|Drug|Aerosolized Placebo|Aerosolized placebo every 12 hours for 10 days to be administered using the Pulmonary Drug Delivery System (PDDS Clinical)
16147630|NCT01799954|Biological|DNA-HIV-PT123|4 mg of DNA encoding clade C ZM96 Gag and gp140, CN54 Pol-Nef, administered intramuscularly (IM)
16147631|NCT01799954|Biological|NYVAC-HIV-PT1|(along with NYVAC-HIV-PT4); ≥ 5x106 PFU encoding clade C ZM96 gp140 and ZM96 Gag and CN54 Pol-Nef, administered IM
16147632|NCT01799954|Biological|NYVAC-HIV-PT4|(along with NYVAC-HIV-PT1); ≥ 5x106 PFU encoding clade C ZM96 gp140 and ZM96 Gag and CN54 Pol-Nef, administered IM
16147633|NCT01799954|Biological|AIDSVAX® B/E|300mcg of subtype B (MN) HIV gp120 glycoprotein and 300mcg of subtype E (A244) HIV gp120 glycoprotein absorbed onto 600mcg of aluminum hydroxide gel adjuvant, administered IM.
16147634|NCT01799954|Biological|Placebo for DNA/NYVAC|Sodium Chloride for injection, 0.9% administered IM
16147635|NCT01799954|Biological|Placebo for AIDSVAX(R) B/E|600 mcg of aluminum hydroxide adjuvant, administered IM
16147636|NCT01799941|Drug|Nuedexta (DM 20 mg/Q 10 mg)|Single Arm, Open-Label Dosing with Nuedexta (DM 20 mg/Q 10 mg)
16147637|NCT01799902|Drug|Solifenacin|Oral
16147638|NCT01799889|Drug|Entospletinib MM|Entospletinib MM tablet administered orally
16147639|NCT01799889|Drug|Entospletinib SDD|Entospletinib SDD tablet administered orally
16147640|NCT01799876|Procedure|Autologous Cell|
16147641|NCT01799876|Procedure|Standard microfracture arthroscopic surgery|
16147642|NCT01799863|Drug|Ketorolac trometamol 0.45% with carboxymethylcellulose|
16147643|NCT01799863|Drug|Preservative free artificial tear|
16147644|NCT01799850|Drug|Pioglitazone|pioglitazone 30 mg daily, pill, eight weeks, placebo randomly assigned
16147645|NCT01799850|Drug|placebo|placebo assigned randomly, double blind
16147646|NCT01799837|Drug|[C-11]MENET|PET imaging involves injecting small amounts of a radioactive material into the blood stream. The radioactive material is attached to a drug called MENET that will give information about how the brain interacts with a protein called norepinephrine (NE).
16147647|NCT01799824|Biological|ANT-1403|
16147648|NCT01799824|Biological|placebo|
16147649|NCT01799798|Drug|Denosumab|Denosumab will be given subcutaneously in a dosage of 1mg/kg body weight every 12 weeks. 4 interventions are planned until trial week 36. There is no control group planned.
16147650|NCT01799785|Behavioral|Aerobic exercise|Aerobic exercise for 8 weeks (3 times per week, 30-60 minutes each session)
16147651|NCT01799785|Other|Usual Care|
16147652|NCT01799772|Behavioral|Comprehensive Behavioral Intervention|"Evidence-based exercise program - Combination of high intensity lower extremity strengthening, endurance on the treadmill, functional task-oriented exercises, and balance techniques. During 12 sessions, subjects will be instructed to become independent in performing the exercises at home.
~Physical activity promotion - Instructions to engage in moderate intensity exercise 5 days/week will be delivered along with the exercise program.
~Healthy nutrition guidance - Instructions on healthy nutrition delivered by a dietitian.
~Self-management - Basic self-management skills advocated by the Arthritis Foundation Self-Help Program and behavioral strategies (self-monitoring, problem solving, relapse prevention, and goal-setting) and feedback into approaches a, b and c."
16147653|NCT01799772|Other|Standard of Care Exercise Program|Typical rehabilitation after TKA surgery
16147654|NCT01799759|Behavioral|Online intervention|Child online intervention is 8 modules based on the Health Promotion/Transtheoretical Model Parent online intervention is 6 modules based on enhancing authoritative parenting,support and role models for improved nutrition, physical activity and health child body mass percentile
16147655|NCT01799759|Other|Completion of instruments only|Parent and child subejects in the waiting list control only complete surveys, body composition and fitness tests
16147656|NCT01799733|Other|LWT+AM BWL|One night of late wake therapy (LWT)(sleep 21:00-01:00 h, followed by wakefulness) plus 7 days of morning bright white light (AM BWL)(light-emitting diode-LED administered for 60 minutes, starting within 30 minutes of habitual wake time)
16147657|NCT01799733|Other|EWT+PM BWL|One night of early wake therapy (EWT) (wakefulness until 03:00 h, then sleep 03:00-07:00 h) plus 7 nights of evening bright white light (PM BWL)(light-emitting diode-LED administered 90 minutes before habitual sleep onset, for 60 minutes)
16147658|NCT01799720|Dietary Supplement|Less oxidized oil and diet|Analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements. For this purpose we have designed a single-blind, parallel-groups, randomized controlled trial. Finally 52 women between 25 and 75 years old randomly were distributed into three groups. Participants from group 1 took 2 capsules/day of one of the less oxidized oil (containing 300 mg EPA + DHA) and diet, . Follow-up 30 days
16147659|NCT01799720|Dietary Supplement|More oxidized oil and diet|Analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements. For this purpose we have designed a single-blind, parallel-groups, randomized controlled trial. Finally 52 women between 25 and 75 years old randomly were distributed into three groups. Participants from group 2 took 2 capsules/day of one of the more oxidized oil (containing 300 mg EPA + DHA) and diet . Follow-up 30 days
16147660|NCT01799720|Drug|Hypercholesterolemic diet|Analyze the effect of dietary supplements Omega-3 with different levels of oxidation in the lipid profile of women who consume these supplements. For this purpose we have designed a single-blind, parallel-groups, randomized controlled trial. Finally 52 women between 25 and 75 years old randomly were distributed into three groups. Participants from group 3 only received the diet and no capsules. Follow-up 30 days
16147661|NCT01799707|Behavioral|vision restoration training|visual stimuli repetitively presented to stimulate areas of residual vision. The training consists of luminance increment stimuli similar to perimetry and the task isa simple detection task (pressing a key whenever a target stimulus was detected).
16147662|NCT01799707|Behavioral|Discrimination Training|the stimulus is a line segment (bar) which is always presented within the central ±5° visual field in one of four possible random orientations: horizontal, vertical, oblique to the right or oblique to the left. If the patient has visual field defects in this central area, 80% of the stimuli are presented in the intact part of the training region. The task is to identify the orientation of the line segment and press, as fast as possible, one of 4 assigned buttons on the keyboard.
16147663|NCT01799694|Drug|Inject of Autologous Adipose-derived stem cells|Inject in muscle of autologous adipose derived stem cells
16147664|NCT01799681|Behavioral|an 8-week blended indoor-outdoor exercise program|stretching, strength and functional training, Balance Dance, Modified Wing Chun, Square stepping exercise, and fall-prone activities practice
16147665|NCT01799681|Behavioral|an 8-week upper limb and hand exercise program|upper limb stretching and strengthening, hand agility exercises, knot tying and Chinese calligraphy
16147666|NCT01799629|Drug|Glycerin suppositories|
16147667|NCT01799616|Drug|Pamidronate|
16147668|NCT01799616|Other|Placebo|
16147669|NCT01799603|Drug|TMC435|TMC435, 100 milligram oral capsule will be administered on Day 1 of each treatment period, separated by washout period of 9 days.
16147670|NCT01799590|Drug|Topiramate|Topiramate tablets will be administered orally in the dose range of 50 to100 milligram per day (mg/day). Dose will be increased or decreased as per Investigator's discretion. Maximum daily dose limit will be 200 mg.
16147671|NCT01799577|Procedure|Laparoscopic surgery|Two methods will be compare
16147672|NCT01799564|Procedure|Micropulse|Between 1 and 3 sessions of micropulse laser will be applied in the inferior hemiretina of the randomly selected eye
16147673|NCT01799551|Behavioral|Ca CBT|Clients in intervention group will receive a CBT intervention using a manual. Intervention was developed for use in primary and secondary care using a series of qualitative studies (Naeem et al a, 2010, Naeem et al c, 2009, Naeem et al, 2009, Naeem et al, in press) during the last 5 years in Pakistan and has proven to be effective in a pilot study (Naeem et al, 2011). Intervention will consist of 6 sessions and will focus on psycho-education, symptoms management, changing negative thinking, problem solving, improving relationships and communication skills. One person from the family will be involved as a facilitator.
16147677|NCT01799525|Procedure|Hypercapnia by reduction of respiratory volume|By reduction of the respiratory volume, PaCO2 is raised while paO2 is kept constant by modulation of the oxygen supply through the respirator,
16147678|NCT01799512|Device|experimental: real-time continuous glucose monitoring|
16147679|NCT01799512|Device|Active comparator: blinded continuous glucose monitoring|
16147680|NCT01799499|Device|TC-3 hydrogel|
16147681|NCT01799499|Device|TC-3 hydrogel|
16147682|NCT01799499|Device|TC-3 hydrogel|
16147683|NCT01799486|Drug|Telbivudine|600 mg monotherapy supplied in film-coated tablets.
16147684|NCT01799486|Drug|Enecavir|0.5 mg monotherapy supplied in tablets.
16147685|NCT01799486|Drug|Adefovir|10 mg monotherapy supplied in tablets.
16147686|NCT01799460|Drug|The Comprehensive Treatment Regimen of Traditional Chinese Medicine|"①ShenQiMoShen Decoction: which plays vital therapeutic effect in the CTR,the dosage is 150ml per serving and two services per day.Dosage and administration:150ml per time,twice per day
~②HuoXueTongMai Capsule : which plays a vital role of promoting blood circulation and removing blood stasis. Its main components are the leeches. Dosage and administration: 4 capsules 3 times daily.
~③HeiLiaoDou Particle: which will be prescribed when hypoproteinemia (serum albumin concentration≤30g/L)occurred and should be stopped taking until the serum albumin is above 30g/L. Dosage and administration: 2 packages 3 times daily."
16147687|NCT01799460|Drug|The immunosuppressive agents|According to Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guideline for glomerulonephritis
16147688|NCT01799447|Behavioral|Early intervention|Interventions by health visitors with 18 months training in the Marte Meo method in order to promote relations between parents and infants.
16147689|NCT01799434|Other|treadmill run|
16147690|NCT01799382|Other|Rapid on-site evaluation|Rapid on-site evaluation consists on the cytological evaluation of samples obtained during a diagnostic procedure by a pathologist present in the diagnostic suite. In the present study, cytological samples obtained with EBUS-TBNA during bronchoscopy will be evaluated.
16147691|NCT01799382|Device|EBUS-TBNA|EBUS-TBNA is a needle aspiration procedure guided by endobronchial ultrasounds performed during bronchoscopy
16147692|NCT01799369|Behavioral|Surgical Apgar Score|Post-operative care influenced by Surgical Apgar Score
16147693|NCT01799356|Drug|Moxifloxacin|daily 400 mg moksifloksasin
16147694|NCT01799356|Drug|Ofloxacin|daily 800 mg oflaksasin plus 1000 mg metronidazol treatment
16147695|NCT01799356|Drug|Metronidazole|daily 1000 mg metronidazol plus 800 mg oflaksasin treatment for uPID
16147696|NCT01799343|Other|Immersion into water|Measurements of mean arterial pressure, deepest vertical pocket of amnion fluid and Doppler flow in the umbilical and uterine arteries will be assessed before immersion, during immersion and after immersion.
16147697|NCT01799330|Procedure|Transcutaneous Electrical Muscle Stimulation (TCEMS)|
16147698|NCT01799330|Other|Sham TCEMS|Patients randomized to Group 2 (Sham TCEMS) will receive the identical set-up for active TCEMS except they will receive a minimal electrical stimulus that does not produce a motor response
16147699|NCT01799317|Drug|Vitamin D2|These patients will receive standard of care vitamin D 1,25 therapy with intervention of vitamin D2
16147700|NCT01799304|Procedure|no distractor control group|This control condition will aim at analyzing posture and locomotion in CP children with the intent to focus attention on their equilibrium, only, without any other interference.
16147754|NCT01798901|Drug|decitabine|Given IV
16147755|NCT01798901|Other|laboratory biomarker analysis|Correlative studies
16147756|NCT01798901|Other|pharmacological study|Correlative studies
16147701|NCT01799304|Procedure|visual and sound attentional distractors|The distractors will be used to orient subjects' attention toward another simple and motivating task in order to avoid focalisation on postural control and locomotion and to favour a more automatic control.
16147702|NCT01799304|Procedure|sound attentional distractor alone|In addition to the previous condition, the goal of the present condition is to isolate the effects of a sound distractor, since it is known that CP children frequently exhibit visual deficits which may affect their postural and locomotion difficulties.
16147703|NCT01799304|Procedure|additional cognitive task|The additional cognitive task aimed to increase the attentional load and to analyse its impact on children's capacity to process two tasks simultaneously (the cognitive and postural or locomotor tasks)
16147704|NCT01799291|Behavioral|Decision Making Tutorial|"A web-based presentation focused on key cognitive de-biasing strategies, including helping clinician participants: consider alternative diagnoses (e.g., symptom checklists); decrease reliance on memory (e.g., mnemonics); and incorporate Bayesian reasoning (e.g., actuarial approaches)."
16147705|NCT01799278|Drug|MLN8237|MLN8237 will be administered orally. The study drug will be administered on an empty stomach with the patient remaining nothing by mouth (NPO), except for water and prescribed medications, for 2 hours before and 1 hour after each dose. Patients will be instructed to take each oral dose of MLN8237 with 8 ounces (1 cup, 240 mL) of water.
16147706|NCT01799265|Device|Somnetics Transcend Auto|
16147707|NCT01799265|Device|Respironics REMstar Auto with C-Flex|
16147708|NCT01799239|Device|Test product|The test product consists of an adhesive with a new top film
16147709|NCT01799239|Device|SenSura|SenSura is the CE-marked and commercially available comparator product
16147710|NCT01799226|Other|Toothpaste without triclosan|this intervention will use a toothpaste without triclosan
16147711|NCT01799226|Other|Triclosan|this intervention will use Colgate Total which contains triclosan
16147712|NCT01799213|Drug|Meloxicam 15 mg po QD|Eligible subjects will be take Meloxicam 15 mg po QD
16147713|NCT01799213|Behavioral|Cognitive Behavioral Therapy|Subjects originally assigned to placebo will receive cognitive behavioral therapy for 10 weeks
16147714|NCT01799187|Procedure|revascularization|revascularization include 3 steps: root disinfected,induction of bleeding and revascularization include 3 steps: root disinfected,induction of bleeding and sealing
16147715|NCT01799187|Procedure|apexification|apexification uses calcium hydroxide as root medication
16147716|NCT01799174|Procedure|UVA-1 Phototherapy|
16147717|NCT01799174|Procedure|Placebo|
16147718|NCT01799161|Biological|gp96-Ig Vaccine|
16147719|NCT01799161|Drug|Theophylline|300 mg capsule daily of Theophylline during 1st course, then adjusted dose
16147720|NCT01799161|Other|Oxygen|24-hr oxygen delivered via nasal cannula or oxygen mask during 1st course, then adjusted dose.
16147721|NCT01799161|Procedure|Immunologic Evaluation|Frequency of IFN-y,CD8 cells in response to vaccine in available tumor samples Blood draw to assess immunological response [frequency of CD4+, FoxP3 (Treg), et al] in treated patients.
16147722|NCT01799148|Other|Particulate air pollutants|We will determined the average concentrations of different sizes of particulate matter from 1 day or up to 7 days prior to admission in patients with acute coronary syndrome.
16147723|NCT01799135|Other|DCE-MRI scan|
16147724|NCT01799135|Radiation|Stereotactic Body Radiation Therapy|
16147725|NCT01799135|Other|4D-CT scan|
16147726|NCT01799122|Device|Mini Arc Precise Pro and Trans vaginal obturator sling (TVT-0)|
16147727|NCT01799109|Drug|Magnesium Sulfate & albuterol|
16147728|NCT01799109|Drug|albuterol|
16147729|NCT01799109|Drug|magnesium|
16147730|NCT01799096|Dietary Supplement|Sucrose|Sucrose in carbonated soft drinks (4 x250ml total1800 kJ per day)
16147731|NCT01799096|Dietary Supplement|Aspartame|Intensely sweetened soft drink (no energy content)
16147732|NCT01799083|Drug|Decitabine|A continuous 5-day lower-dose decitabine transfusion will be performed for patients during each treatment cycle, and autologous cytokine-induced killer cells may be transfused or chemotherapy may be also added.
16147733|NCT01799083|Biological|cytokine-induced killer cell|Autologous cytokine-induced killer cells may be used for patients before and after decitabine treatment.
16147734|NCT01799057|Drug|Metformin|Participants randomized to metformin will be treated at a maximum dose of 2000mg per day (i.e. 1000mg twice daily for 16-18 weeks; up-titrated from 500mg twice daily for the first 2 weeks). Participants may complete the 16-18 week treatment intervention at the lower dose of 500mg twice daily if limited by side effects.
16147735|NCT01799057|Drug|Placebo|Participants randomized to placebo will take matching oral capsules according to the same dose schedule specified for the metformin intervention.
16147736|NCT01799044|Device|Irreversible electroporation (IRE)|Tumor ablation with irreversible electroporation with the NanoKnife
16147737|NCT01799031|Other|internet-based intervention|Receive access to the WISE web-based educational intervention
16147738|NCT01799031|Procedure|management of therapy complications|Receive standard of care
16147739|NCT01799031|Other|educational intervention|Receive access to the WISE web-based educational intervention
16147740|NCT01799031|Other|questionnaire administration|Ancillary studies
16147741|NCT01799031|Procedure|quality-of-life assessment|Ancillary studies
16147742|NCT01799005|Dietary Supplement|Flavanol (410 mg)|
16147743|NCT01799005|Dietary Supplement|Control (no flavanols)|
16147744|NCT01798992|Drug|Carvedilol|
16147745|NCT01798992|Drug|Metoprolol succinate|
16147746|NCT01798992|Drug|Metoprolol succinate + doxazosin|
16147747|NCT01798979|Drug|GLPG0634|Each subject will receive multiple oral doses of GLPG0634 (200 mg daily for 7 days) from Days 2 to 8.
16147748|NCT01798979|Drug|Midazolam|Each subject will receive a single oral dose of midazolam (2 mg) on 2 occasions (Days 1 and 8)
16147749|NCT01798966|Device|SENSIMED Triggerfish|
16147750|NCT01798940|Drug|Torrent's Pioglitazone|
16147751|NCT01798927|Device|Ankle foot orthosis|Participants will receive a Tamarack ankle foot orthosis with a check strap for gait training as well as a home walking program.
16147752|NCT01798914|Drug|Technosphere Insulin Inhalation Powder|Patient Transitioning From Exubera® Inhalation Powder to Technosphere® Insulin Inhalation Powder
16147753|NCT01798901|Drug|HDAC inhibitor AR-42|Given PO
16147757|NCT01798888|Procedure|Implantation of Deep Brain Stimulation|
16147758|NCT01798875|Drug|oral metformin|
16147759|NCT01798875|Drug|oral contraceptive|
16147760|NCT01798862|Procedure|Endometrial injury by hysteroscopy or pipelle sampling|
16147761|NCT01798862|Procedure|Proceed to COH directly|
16147762|NCT01798849|Drug|MK-8892|
16147763|NCT01798849|Drug|Placebo for MK-8892|
16147764|NCT01798836|Procedure|Oestradiol pre-treatment and combination of GnRH agonist/antagonist protocol|
16147765|NCT01798836|Procedure|GnRH agonist or antagonist protocol without oestradiol pre-treatment|
16147766|NCT01798823|Procedure|History, physical, LF, SPT, blood sample, FeNO, EBC.|Medical history and physical examination, (LF) lung function (spirometry, (SETC) standardized exercise treadmill challenge, (BRT) bronchial reversibility test,(MBP) metacholine bronchial provocation), (SPT) skin prick tests, blood sample, (FeNO) fractional exhaled nitric oxide measurements, (EBC) exhaled breath condensate.
16147767|NCT01798810|Procedure|Supplemental Perioperative Oxygen|Patients receiving perioperative oxygen will receive 80% FiO2 during surgery.
16147768|NCT01798784|Behavioral|Sweepstake Incentive 1|Daily sweepstake conditional on daily medication adherence
16147769|NCT01798784|Behavioral|Sweepstake Incentive 2|Daily sweepstake conditional on daily medication adherence
16147770|NCT01798784|Behavioral|Sweepstake Incentive 3|Daily sweepstake conditional on daily medication adherence
16147771|NCT01798771|Procedure|Interventional arm|5-ALA fluorescence guided surgery with the additional use of an intraoperative MRI for resection control in patients with contrast enhancing tumors.
16147772|NCT01798771|Procedure|Control arm|5-ALA fluorescence guided surgery in patients with contrast enhancing tumors.
16147773|NCT01798745|Drug|JNJ-54452840|Once daily intravenous injection(s) (medication is injected into a vein) at doses ranging from 20 mg to 240 mg, given as a single injection (Cohorts A and B); injections given once daily over 3 to 5 days (Cohorts C, D, and F); or injections given once weekly up to Day 22 (Cohorts E and F).
16147774|NCT01798745|Other|Placebo|Once daily matching intravenous injection(s) (medication is injected into a vein) given as a single injection (Cohorts A and B); injections given once daily over 3 to 5 days (Cohorts C, D, and F); or injections given once weekly up to Day 22 (Cohorts E and F).
16147775|NCT01798732|Procedure|Selective Laser Trabeculoplasty (Tango Laser, Ellex)|One session of selective laser trabeculoplasty with the following parameters (inferior half-circumference, 50 shots, 0.8 to 1.3 mJ)
16147776|NCT01798719|Behavioral|Low Glycemic Index Mediterranean Diet|A list of foods that may be consumed frequently (green foods), sometimes (yellow foods) and never (red foods)
16147777|NCT01798719|Behavioral|General Advice|Only general advice about diet
16147778|NCT01798706|Drug|Lixisenatide (AVE0010)|"Pharmaceutical form: Solution for injection in pre-filled pen administered 30 to 60 minutes before breakfast in the morning
~Route of administration: Subcutaneous injection"
16147779|NCT01798706|Drug|Placebo|"Pharmaceutical form: Solution for injection in pre-filled pen administered 30 to 60 minutes before breakfast in the morning
~Route of administration: Subcutaneous injection"
16147780|NCT01798706|Drug|Antidiabetic background therapy|Participants received a stable regimen of anti-diabetic background therapy for at least 3 months prior to screening, during the placebo run-in period and the 24 week treatment period. Allowed background antidiabetic therapy included metformin, sulfonylurea (except glibenclamide >10 mg, gliclazide >160 mg), meglitinides (except repaglinide >6 mg), pioglitazone and basal insulin. Insulin glargine, neutral protamine hagedorn (NPH) insulin, detemir, lente and ultralente were considered as basal insulin.
16147781|NCT01798693|Dietary Supplement|Placebo (maltodextrin)|
16147782|NCT01798693|Dietary Supplement|Multi-nutrient Blend|
16147783|NCT01798680|Dietary Supplement|Vitamin D3 (cholecalciferol)|Supplements containing 50,000 IU of vitamin D3 (cholecalciferol) taken orally once per week for 4 weeks (weeks 0, 1, 2, 3) followed by 2,000 IU of vitamin D3 (cholecalciferol) supplements taken orally once per day starting at 4 weeks until study discharge at 12 months
16147784|NCT01798680|Other|Placebo|Placebo pills taken once weekly for 4 weeks (weeks 0, 1, 2, 3) followed by placebo pills taken orally once per day starting at 4 weeks until study discharge at 12 months
16147785|NCT01798667|Drug|DA-8031|
16147786|NCT01798667|Drug|Placebo|Placebo of DA-8031, undistinguishable
16147787|NCT01798641|Device|MIETHKE proGAV® / MIETHKE proSA®|The programmable shunt will be adjusted through the MIETHKE proGAV® / MIETHKE proSA® valve and crossed over at 6 weeks. The open shunt will be adjusted to be closed. The closed shunt will be adjusted to open.
16147788|NCT01798628|Drug|Treatment A: abiraterone acetate|1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered after a high-fat meal
16147789|NCT01798628|Drug|Treatment B: abiraterone acetate|1000 mg (4 x 250 mg tablets) taken by mouth as a single dose after a low-fat meal
16147790|NCT01798628|Drug|Treatment C: abiraterone acetate|1000 mg (4 x 250 mg tablets) taken by mouth as a single dose administered in the fasted state
16147791|NCT01798602|Drug|Rosuvastatin or identical placebo|Tablet crushed for administration via feeding tube
16147792|NCT01798602|Drug|Placebo|Identical placebo for rosuvastatin
16147793|NCT01798589|Drug|Ethylenediamine dihydrochloride allergen patch|1 allergen panel containing 2 allergen and 2 control patches
16147794|NCT01798576|Drug|Pegylated Interferon alfa-2a|Dosing was at the discretion of the investigator in accordance with local clinical practice and local labelling.
16147795|NCT01798576|Drug|Ribavirin|Dosing was at the discretion of the investigator in accordance with local clinical practice and local labelling.
16147796|NCT01798550|Drug|Enoxaparin|Twice daily dosing
16147797|NCT01798537|Drug|Neomycin Colistin Nystatin Vancomycin|All participating study arm patients will receive SDD from admission to discharge
16147798|NCT01798511|Procedure|Nasogastric Tube Feeding|A nasogastric tube will be placed into the stomach of patients.
16147799|NCT01798511|Other|Conventional Nutritonal Management|Patients who are to have CNM will be on nil-by-mouth regimen until they either develop signs of severe AP (in which case nasojejunal tube feeding will be introduced) or the signs of AP mitigate (in which case clear liquids (as tolerated) followed by oral food (as tolerated) will be introduced)
16147800|NCT01798498|Device|Princess® VOLUME|
16147837|NCT01798225|Drug|Placebo|Participants received mechanical periodontal therapy, oral hygiene instructions and placebo pills.
16147801|NCT01798485|Drug|Docetaxel|Docetaxel, 75 mg/m^2, was administered according to prevailing practice and Investigator decision, generally until disease progression, intolerability, or patient's withdrawal of consent.
16147802|NCT01798485|Drug|Ganetespib|Ganetespib, 150 mg/m^2, was administered with docetaxel. After docetaxel treatment ceased, participants whose disease has not progressed continued to receive ganetespib alone until disease progression, unacceptable toxicity, or patient's withdrawal of consent.
16147803|NCT01798472|Procedure|cemented hemiarthroplasty|Patients aged 80 years and older operated with an cemented hemiarthroplasty. Fixation of the wedge-shaped, polished ChromCobalt steel femoral stem to host bone by use of PolyMetylMetAcrylat bone cement. The acetabulum is not replaced. The prosthesis articulates with the patients acetabulum with an unipolar, femoral head made of ChromCobalt steel.
16147804|NCT01798472|Procedure|reverse hybrid total hip arthroplasty|Patients aged 65 to 79 years operated with an uncemented femoral component combined with cemented acetabular cup. The femoral stem is fixed to the host bone by press-fit technique. We use a tapered, proximally hydroxyapatite coated, titanium stem. The acetabular cup is fixed to the host bone with bone cement. We use an all-polyethylene design. Bone cement consists of PolyMetylMetAcrylat.
16147805|NCT01798472|Procedure|cemented total hip arthroplasty|Patients aged 65 to 79 years operated with a cemented femoral stem combined with a cemented acetabular cup. Femoral and acetabular component are fixed to the host bone by use of bone cement. The femoral stem is a polished, wedge-shaped design made of ChromCobalt steel. The acetabular cup is fixed to the host bone with bone cement.The acetabular cup an all-polyethylene design. Bone cement consists of PolyMetAcrylat.
16147806|NCT01798472|Procedure|uncemented hemiarthroplasty|"Patients aged 80 years and older are randomized to uncemented hemiarthroplasty. Fixation of the tapered, proximally hydroxyapatite coated, titanium stem to the host bone by press-fit-technique. The acetabulum is not replaced. The prosthesis articulates with the patients acetabulum with an unipolar, femoral head made of ChromCobalt steel."
16147807|NCT01798459|Drug|Methylphenidate|
16147808|NCT01798446|Drug|Axitinib|Axitinib 5mg twice will be orally administered daily with one cycle of 4 weeks. The package of axitinib must be opened right before the administration due to its photosensitivity.
16147809|NCT01798433|Device|One stent technique alone|One stent technique alone with drug-eluting stent
16147810|NCT01798433|Device|One stent technique + Elective FKB|One stent technique + Elective FKB with drug-eluting stents + balloon
16147811|NCT01798433|Procedure|Provisional approach|Provisional approach with drung-eluting stents
16147812|NCT01798433|Device|Elective 2-stent|Elective 2-stent with drug-eluting stents
16147815|NCT01798394|Drug|Progesterone|Take micronized natural progesterone capsule by mouth, twice daily (approximately at 8 am and 8 pm) for four weeks beginning on postpartum day 4.
16147816|NCT01798394|Other|Placebo|Take placebo capsule by mouth, twice daily (approximately at 8 am and 8 pm) for 4 weeks beginning on postpartum day 4.
16147817|NCT01798381|Dietary Supplement|Essential fatty acids|
16147818|NCT01798368|Device|PBASE system 2.0|
16147819|NCT01798355|Behavioral|Cognitive Behavioral Therapy|The treatment group is offered cognitive behavior therapy(CBT) by psychologists/psychotherapists. CBT is offered according to a treatment manual and consists of 10- sessions during 12-15 weeks.
16147820|NCT01798355|Behavioral|Treatment As Usual|Treatment as usual consist of strategies such as habituation, tell-show-do, premedication with midazolam, nitrous oxide sedation and general anesthesia. All offered by dentists and dental hygienist and/or dental assistants.
16147821|NCT01798342|Dietary Supplement|Maltodextrin|The volunteers underwent MRI after the ingestion of the dietary supplement in a crossover fashion aiming at measuring the gastric residual volume
16147822|NCT01798342|Dietary Supplement|Glutamine|The volunteers ingested 400ml (4 hours before the exam was carried out) at 8:00AM and 200ml (2 hours before the exam was carried out) at 10:00AM of a beverage containing water plus 12.5% maltodextrin plus 15g of GLN before MRI
16147823|NCT01798329|Dietary Supplement|probiotic VSL#3|"VSL#3 is a probiotic that reduces:
~urease faecal activity
~faecal pH
~inflammatory cytokine"
16147824|NCT01798316|Drug|IV Acetaminophen|Single dose, 1000g mg infusion over 15 minutes plus standard of care pain management regimen
16147825|NCT01798316|Drug|Standard of Care|Standard of care pain management regimen, no IV Acetaminophen,
16147826|NCT01798303|Drug|LY2940094|Administered orally
16147827|NCT01798303|Drug|Placebo|Administered orally
16147828|NCT01798290|Behavioral|narrative medicine: reading workshop|
16147829|NCT01798290|Behavioral|critical reading|
16147830|NCT01798277|Procedure|Catheter Ablation|Catheter ablation of ventricular tachycardia will employ three-dimensional mapping Fast Anatomical Mapping or CARTOSOUND technology (Biosense Webster Inc.), and the Thermocool Navistar catheter (Biosense Webster Inc.).
16147831|NCT01798277|Drug|Medical therapy (sotalol or amiodarone)|Patients will be tiered to one of two possible antiarrhythmic drugs (sotalol or amiodarone).
16147832|NCT01798264|Drug|ITCA 650 (exenatide in DUROS)|
16147833|NCT01798251|Drug|Oxaliplatin|Oxaliplatin 100mg/m2 d1 Intravenous infusion every 3 weeks
16147834|NCT01798251|Drug|Capecitabine|capecitabine 850mg/m2 bid, d1-14, every 3 weeks
16147835|NCT01798238|Drug|MP-513|form : Pink film-coated tablet for oral administration Dosage : 20mg/tablet frequency and duration: 1 tablet/day
16147836|NCT01798238|Drug|Placebo|Pink film-coated tablet for oral administration, frequency and duration: 1 tablet/day
16149559|NCT01784692|Dietary Supplement|Immulina|
16147838|NCT01798225|Drug|Doxycycline|Participants received mechanical periodontal therapy, oral hygiene instructions and Doxycycline 100mg x 14 pills (to be taken one a day for 14 days)
16147839|NCT01798212|Procedure|endoscopic full thickness plication|
16147840|NCT01798199|Other|The training by Verve System|
16147841|NCT01798186|Drug|Cannabis|Participants will be exposed to cannabis smoke present in ambient air
16147842|NCT01798173|Biological|Serum, plasma and DNA samples|
16147843|NCT01798173|Procedure|Radiological exploration by CT scan or MRI|
16147844|NCT01798160|Procedure|DEB TACE|DEB TACE every 6 weeks until either no viable tumor or endpoint reached.
16147845|NCT01798160|Procedure|SIRT|Selective Internal Radiation Therapy once at the beginning of the study. Follow up until endpoint.
16147846|NCT01798147|Procedure|DEB TACE|DEB TACE every 6 weeks until either no viable tumor or endpoint reached.
16147847|NCT01798147|Procedure|SIRT|Selective Internal Radiotherapy once at the beginning of the study. Follow up until endpoint.
16147848|NCT01798134|Device|TANDEM™|
16147849|NCT01798121|Biological|To compare new PPD to reference standard material|Aplisol@ will be compared to reference standard material
16147850|NCT01798121|Biological|Reference standard|Response of reference standard material compared to Aplisol@.
16147851|NCT01798108|Radiation|Radium-223 dichloride (BAY88-8223)|- Single injection. Starting dose 46 kBq/kg b.w. Escalating doses 93, 163, 213 and 250 kBq/kg b.w. (9.8.2 Changes in addition to those described in amendments) After completion of the five dose levels above, the protocol was amended and the study extended to include patients to received multiple injections of Radium-223 - Re-treatment: Patients who had earlier been included in the study and received dose levels 46, 93 or 163 kBq/kg b.w. could be given a second injection, provided that the total dose did not exceed 250 kBq/kg b.w. - Fractionated dose (multiple dosing) Patients were given multiple injections in treatment: 5 injections of 50 kBq/kg b.w. at 3 weeks intervals. Patients were given multiple injections in treatment: 2 injections of 125 kBq/kg b.w. at 6 weeks interval
16147852|NCT01798095|Biological|Aplisol@ PPD material|Determine equivalency of materials
16147853|NCT01798095|Biological|Reference Standard|Reference standard material for comparison to newly produced materials.
16147854|NCT01798082|Other|Pelvic organ prolapse decision aid|
16147855|NCT01798069|Behavioral|reflective writing|Students allocated to the experimental arm will follow 5 sessions in Class-led instruction of reflexive writing workshops. They will be divided into 12 sub-groups of 8 students. They will write their stories about their own experiences or the experiences of their family / patient.
16147856|NCT01798069|Behavioral|reading medical publication workshops|
16147857|NCT01798056|Biological|GSK 1437173A|2 doses administered by intramuscular (IM) injection into the deltoid muscle of the non-dominant arm.
16147858|NCT01798056|Drug|Placebo|2 doses administered by IM injection into the deltoid muscle of the non-dominant arm.
16147859|NCT01798043|Other|Cardiac MRI with pacemaker stimulation|Patient is undergoing a Cardiac MRI at enrollment and 12 months later
16147860|NCT01798043|Other|Cardiac MRI with and without pacemaker stimulation|Patient is undergoing a Cardiac MRI at enrollment and 12 months later
16147861|NCT01798030|Other|Vitamin D|N/A, frozen specimen study
16147862|NCT01798017|Drug|Mifepristone and misoprostol|Women will receive 200mg mifepristone followed in 24-48h by 800mcg bucccal misoprsotol
16147863|NCT01798004|Drug|cyclophosphamide|Given IV
16147864|NCT01798004|Drug|topotecan hydrochloride|Given IV
16147865|NCT01798004|Drug|cisplatin|Given IV
16147866|NCT01798004|Drug|etoposide|Given IV
16147867|NCT01798004|Drug|vincristine sulfate|Given IV
16147868|NCT01798004|Drug|doxorubicin hydrochloride|Given IV
16147869|NCT01798004|Radiation|external beam radiation therapy|Undergo EBRT
16147870|NCT01798004|Drug|busulfan|Given IV
16147871|NCT01798004|Drug|melphalan|Given IV
16147872|NCT01798004|Procedure|autologous hematopoietic stem cell transplantation|Undergo autologous peripheral blood stem cell transplant
16147873|NCT01798004|Procedure|peripheral blood stem cell transplantation|Undergo autologous peripheral blood stem cell transplant
16147874|NCT01798004|Other|pharmacological study|Correlative studies
16147875|NCT01798004|Other|laboratory biomarker analysis|Optional correlative studies
16147876|NCT01798004|Biological|filgrastim|Given SC or IV
16147877|NCT01798004|Drug|mesna|Given IV
16147878|NCT01797991|Drug|Dexamethasone per os|
16147879|NCT01797991|Drug|Matching placebo for dexamethasone IV|
16147880|NCT01797991|Drug|Dexamethasone IV|
16147881|NCT01797991|Drug|Matching placebo for dexamethasone per os|
16147882|NCT01797978|Drug|Intravenous methylene blue administration|Initial history taking and physical examination --> enrollment --> 2mg/kg IV bolus followed by 0.5mg/kg/hr slow infusion of methylene blue for 6hrs
16147883|NCT01797978|Drug|Placebo|
16147884|NCT01797965|Drug|BIIB019 (Daclizumab)|Participants will receive open-label treatment with BIIB019 150 mg subcutaneous injection every 4 weeks for up to 5 years.
16147885|NCT01797952|Drug|Lactobacillus CD 2|2x109 (2 billion) viable cells of Lactobacillus CD2 as active ingredient
16147886|NCT01797952|Other|Placebo|The placebo is a mix of sugars and salts used as excipients in the active formulation
16147887|NCT01797926|Drug|Reference Treatment: 5 mg amlodipine + 50 mg losartan|Subjects will receive 1 x 5 mg amlodipine tablet with 1 x 50 mg losartan tablet administered orally in fasted state as a single dose
16147888|NCT01797926|Drug|Reference Treatment:5 mg amlodipine + 100 mg losartan|Subjects will receive 1 x 5 mg amlodipine tablet with 1 x 100 mg losartan tablet administered orally in fasted state as a single dose
16147889|NCT01797926|Drug|FDC 5/50 amlodipine/ losartan|Subjects will receive single oral dose of 1 tablet containing 5 mg amlodipine and 50 mg losartan in fasted state
16147890|NCT01797926|Drug|FDC 5/100 amlodipine /losartan|Subjects will receive single oral dose of 1 tablet containing 5 mg amlodipine and 100 mg losartan in fasted state
16147891|NCT01797913|Drug|gemcitabine|gemcitabine，1000mg/m2，ivgtt，DAY1&DAY8
16147892|NCT01797900|Drug|Cisplatin|induction: Cisplatin: 80mg/m2, d1 and d22 concurrent: Cisplatin: 100mg/m2, d1, 22, 43 adjuvant: cisplatin: 75mg/m2, d1, d22, d43,d64
16147893|NCT01797900|Drug|Paclitaxel|induction: paclitaxel 175mg/m2 d1,d22 adjuvant: paclitaxel 175mg/m2 d1,d22, d43,d64
16147894|NCT01797900|Radiation|IMRT|69.96Gy-73.43Gy to gross tumor volume, 60Gy to high-risk clinincal target volume, 50Gy to lower risk clincial target volume
16147895|NCT01797887|Behavioral|Diet and Lifestyle Counseling|Diet and Lifestyle Counseling
16147896|NCT01797874|Drug|Pazopanib|Experimental
16147897|NCT01797874|Drug|Placebo|placebo arm
16147898|NCT01797861|Procedure|Half-dose photodynamic therapy (PDT)|"At exactly 15 minutes after the start of the half-dose verteporfin infusion, the PDT treatment will take place. The area that has to be treated with the PDT laser is determined based on those hyperfluorescent area(s) on mid-phase (approximately 10 minutes) ICG-angiography that correspond to subretinal fluid accumulation in the macula on the OCT scan and hyperfluorescent hot spots on the mid-phase (approximately 3 minutes) fluorescein angiogram. The spot size will be defined based on diameter of the hyperfluorescent area on ICG angiography plus 1mm. The treatment is performed with standard fluency (50 J/cm2), a PDT laser wavelength of 689 nm, and a standard treatment duration of 83 seconds."
16147899|NCT01797861|Procedure|Micropulse laser (ML) treatment|"The following ML treatment settings will be used: a power of 1800 mW*, a duty cycle of 5%, frequency of 500 Hz, exposure time of 0.2 s per spot, spot size: 125 µm, minimal distance of spot from fovea: 500 µm.
~* Subthreshold treatment is desired, meaning that no visible reaction due to laser treatment has to be seen in the retina. In virtually all patients, a power of 1800 mW wil not produce a visible discoloration of the retina after application of a laser spot with the aforementioned settings. If retinal discoloration is seen at a power of 1800 mW the power will be reduced with steps of 300 mW until there is no visible reaction. The first laser test spot will always be applied just outside the macular area."
16147900|NCT01797848|Drug|Peginterferon alfa 2a|
16147901|NCT01797848|Drug|Ribavirin|
16147902|NCT01797848|Drug|Placebo matching Daclatasvir|
16147903|NCT01797848|Drug|Daclatasvir|
16147904|NCT01797835|Behavioral|CHAT brief MI intervention|CHAT is one 15-20 minute session delivered in a single PC visit and utilizes motivational interviewing with youth to target alcohol and drug use in primary care.
16147905|NCT01797835|Behavioral|usual care|Youth receive a brochure with information on AOD use.
16147906|NCT01797822|Drug|Dexamethasone|
16147907|NCT01797822|Drug|Artificial tear|
16147908|NCT01797809|Drug|EV/DNG (Qlaira, BAY86-5027)|Patients in daily life clinical practice tratment receiving Qlaira according to indication on the label.
16147909|NCT01797796|Drug|PF-06305591|150 mg PF 06305591 will be administered to subjects as a 100 mL extemporaneous prepared oral solution once.
16147910|NCT01797796|Other|Capsaicin challenge|110 mg capsaicin cream (Axsain®) will be applied topically at each visit.
16147911|NCT01797796|Drug|Placebo|Placebo will be administered to subjects as a 100 mL extemporaneous prepared oral solution once.
16147912|NCT01797796|Other|Capsaicin challenge|110 mg capsaicin cream (Axsain®) will be applied topically at each visit.
16147913|NCT01797783|Device|Nelfilcon A multifocal contact lens with comfort additive|
16147914|NCT01797783|Device|Nelfilcon A multifocal contact lens|
16147915|NCT01797770|Drug|polyethylene glycol|mechanical bowel preparation with polyethylene glycol one day prior to surgery
16147916|NCT01797770|Other|No Preparation|No laxatives or bowel preparation
16147917|NCT01797757|Dietary Supplement|Fish oil enriched with EPA|
16147918|NCT01797757|Dietary Supplement|MAG-EPA oil|
16147919|NCT01797757|Drug|Orlistat|
16147920|NCT01797744|Other|Vestibular rehabilitation|Usual rehabilitation and four different vestibular rehabilitation exercises, adapted to the individual patient
16147921|NCT01797731|Device|Digital hand-held surgical navigation system|Digital hand-held surgical navigation system used for tibial component placement in total knee arthroplasty
16147922|NCT01797731|Device|Conventional tibial extramedullary alignment system|This is the standard of care for total knee arthroplasty.
16147923|NCT01797718|Drug|Testosterone|1mg/kg every 4 weeks for 6 months
16147924|NCT01797718|Drug|Letrozole|2.5mg daily for 6 months. Safety criteria: if testosterone level is above 30nM at 3 months, the dosage is reduced to 2.5mg every other day
16147925|NCT01797705|Device|DeVilbiss AutoAdjust CPAP with revised algorithm|Subjects attended a one-night polysomnogram (PSG) titration study. DeVilbiss AutoAdjust CPAP with a revised algorithm was compared to hand-scored PSG to determine whether the machine results were equivalent to hand scores. Each subject acted as their own control for assessing accuracy of sleep event analysis and prescribed CPAP pressure.
16147926|NCT01797692|Other|geriatric assessment|A single geriatric assessment with a geriatrician was proposed to patients and to control population.
16147927|NCT01797679|Other|Strength Training|
16147928|NCT01797679|Other|Aerobic Exercise|
16147929|NCT01797666|Drug|Torrent's Pioglitazone Hydrochloride Tablets 45 mg|
16147930|NCT01797653|Other|CPAP therapy withdrawal|CPAP (continuous positive airway pressure) with subtherapeutic pressure during two weeks
16147931|NCT01797653|Procedure|Continue CPAP treatment|Continue treatment with therapeutic continuous positive airway pressure device
16147932|NCT01797601|Drug|Human Insulin|160 U of insulin
16147933|NCT01797601|Drug|Placebo|Insulin dilution medium without insulin
16147934|NCT01797588|Procedure|Adductor-canal block|The adductor-canal will be located via ultra sound and a total of 30mL of 0.33% ropivacaine will be injected into the area surrounding the saphenous nerve.
16147935|NCT01797588|Procedure|Periarticular infiltration|Periarticular infiltration will be performed intra-operatively and involves administering a 110 mL solution of ropivacaine 300mg, preservative free morphine 10mg, ketorolac 30mg mixed in normal saline into the knee. In each Knee: the first 20mL aliquot is injected into the posterior capsule and the medial and lateral ligaments just prior to implantation; after the implants have been cemented and curing, another 20mL is infiltrated to the quadriceps and retinacular tissues. The remaining solution (~60mL) is used to infiltrate the muscle, subcutaneous tissues.
16147936|NCT01797575|Drug|Aspirin|aspirin 1000mg (2 capsules of 500mg) every morning in addition to his/her antidepressant and/or mood stabilizer medicine
16147937|NCT01797575|Dietary Supplement|N-acetyl-cysteine (NAC)|taking N-acetyl-cysteine (NAC) 1000mg (2 capsules of 500mg) two times a day in addition to his/her antidepressant and/or mood stabilizer medicine
16147938|NCT01797575|Drug|Sugar Pill|research subject will be taking placebo in addition to his/her antidepressant and/or mood stabilizer medicine
16147939|NCT01797562|Diagnostic Test|Panels 1.3, 2.2 and 3.2 experimental allergens|Three allergen panels will be applied to the upper backs of study subjects and will be worn for 48 hours. Allergen test sites will be evaluated at 3, 4, 7(±1) and 21(±2) days post application.
16147940|NCT01797536|Drug|Elbasvir|
16147941|NCT01797523|Drug|Metformin|500 mg by mouth daily for 4 days on Days 1 - 4 of Cycle 0 and then 2 times a day (about 12 hours apart) every day after that. Metformin taken for 7 - 10 days in Cycle 0 before Cycle 1 begins.
16147942|NCT01797523|Drug|Letrozole|2.5 mg tablet by mouth once daily in a 28 day cycle.
16147943|NCT01797523|Drug|Everolimus|10 mg by mouth once daily in a 28 day cycle.
16147944|NCT01797510|Behavioral|Web Based Health Coaching|
16147945|NCT01797497|Behavioral|Care plan and coaching|In the intervention group, primary care providers and parents complete their sections of the referral care plan. Parents and referred specialists receive a copy of the form. Parents receive a 5-10 minute brief intervention by phone consisting of education and coaching. The care plan is reviewed with parents to help them practice exchanging information with the specialist and encourage parents to contact their child's primary care provider with any further questions. At the specialist visit, specialists review and complete the care plan with the parent and return the plan to the referring primary care provider. Outcome data are collected from parents before and after the specialist visit.
16147946|NCT01797484|Drug|Ranolazine|Improvement of myocardial microcirculation
16147947|NCT01797471|Radiation|Lattice Extreme Ablative Dose (LEAD) Radiation Therapy|A single fraction of LEAD RT, dose of 18 Gy will be delivered to subjects on day 1
16147948|NCT01797458|Procedure|Hall Technique|"Technique:
~Removal of dental plaque and rest of aliments from the cavity
~Selection of the SSC
~If the contact points are very tight, orthodontic separator elastics could be placed through the mesial and distal contacts and the SSC has to be fitted at a subsequent appointment
~Dry the crown and fill with glass-ionomer luting cement
~Place the crown over the tooth
~Removal of cement excesses from the crown margins
~The child should be asked to keep biting on the crown until the cement has set"
16147949|NCT01797458|Procedure|Non-Restorative Caries Treatment|"Technique:
~A high-speed bur should be used to remove the undermined enamel and make the cavity accessible for plaque removal. Do not remove the contact area
~Clean, dry the cavity and apply Duraphat® varnish fluoride (50/mg/ml)
~Show the cavity to patient/parents and give them tooth-brushing instructions
~Tell to parents that good plaque control is the key for this treatment
~The recall interval for these patients is every 3 months."
16147950|NCT01797458|Procedure|Conventional Restoration|"Technique:
~Local anesthesia should be used when needed
~Perform complete caries removal and cavity preparation
~Use a matrix band and a wedge to tightly hold the band against the tooth
~Place the material (Compomer)
~Check contacts and occlusion, and polish the restoration"
16147951|NCT01797445|Drug|E/C/F/TAF|150/150/200/10 mg FDC tablet administered orally once daily
16147952|NCT01797445|Drug|E/C/F/TDF|150/150/200/300 mg FDC tablet administered orally once daily
16147953|NCT01797445|Drug|E/C/F/TDF Placebo|Tablet administered orally once daily
16147954|NCT01797445|Drug|E/C/F/TAF Placebo|Tablet administered orally once daily
16147955|NCT01797432|Drug|Intralesional Triamcinolone Acetonide 10 mg/mL (Kenalog-10)|Intralesional injections of 4mLs Triamcinolone Acetonide 10 mg/mL (Kenalog-10) on the whole scalp
16147956|NCT01797432|Device|Restylane|Intralesional injections of 2mLs of Restylane on one side of the scalp
16147957|NCT01797419|Drug|GS-5806|Single dose, oral liquid, .5 mL/kg
16147958|NCT01797419|Drug|Placebo|Single dose, oral liquid, .5 mL/kg
16147959|NCT01797406|Other|Air insufflation|Air is inflated into the bowel to help searching the cavity while advancing the colonoscope until reaching the cecum
16147960|NCT01797406|Other|Water injection|Water was injected through the working channel instead of air to follow the intestinal cavity until reaching the caecum .
16147961|NCT01797393|Other|Air insufflation|Air is inflated into the bowel to help searching the cavity while advancing the colonoscope until reaching the cecum.
16147962|NCT01797393|Other|Water injection|Water was injected through the working channel instead of air to follow the intestinal cavity until reaching the caecum .
16147963|NCT01797393|Other|" Air assisted water injection."|Cut off air inflating before examination. Water was injected through the working channel to follow the intestinal cavity until reaching the splenic flexure, small amount of air inflating could be given to help searching the cavity until reaching the cecum.
16147964|NCT01797380|Drug|Placebo|Placebo daily for duration of double-blind portion of trial
16147965|NCT01797380|Drug|Escitalopram|Escitalopram 10 mg po daily for duration of double-blind portion of trial
16147966|NCT01797354|Behavioral|Cognitive-behavioral therapy and hypnosis group|
16147967|NCT01797354|Behavioral|Support group|
16147968|NCT01797341|Drug|Tacrolimus|
16147969|NCT01797341|Drug|Tacrolimus|
16147970|NCT01797328|Procedure|cold arm|1 hour/day of cold provocation of such an extent that it is unpleasant but does not cause shivering
16147971|NCT01797328|Procedure|warm arm|To the best of ability avoid feeling cold during 6 weeks
16147972|NCT01797315|Drug|Sirolimus|
16147973|NCT01797302|Dietary Supplement|Vitamin D3|Tablet form
16147974|NCT01797289|Other|Lung CT or V/Q scanning in patients with a high pre-test clinical probability of PE and/or a positive D-dimer|
16147975|NCT01797276|Drug|Dichloroacetate|Subjects are given DCA 25mg/kg in a divided dose twice a day.
16147976|NCT01797263|Other|Yoga|A 12-week yoga intervention modified for Veterans with fibromyalgia. Each weekly session will last approximately 75 minutes. The standardized sequence of yoga poses will be introduced to participants and the instructor will tailor them to the participant's needs and abilities. Deep breathing exercises will be taught and emphasized throughout every session. Participants will be encouraged to exercise according to their limits, rather than rigid adherence to posture techniques. The yoga intervention will be tailored to the individual. It will include low intensity, low impact modified poses adapted with pathophysiologic changes of fibromyalgia in mind. Participants will also be given a Playaway(c) device with guided relaxation exercise recorded on it and asked to listen to it three times a week to reinforce the in person yoga session content.
16148005|NCT01797042|Behavioral|Dietary Compliance|Incorporation of sugar sweetened milk into the usual diet. Instruction on how to account for additional calories provided by sugar sweetened milk Weekly compliance checks
16149867|NCT01782352|Dietary Supplement|Vitamin D3|
16147977|NCT01797263|Other|Structured Exercise|A 12-week group exercise session consisting of a graded aerobic exercise program. The program will start at low intensity with gradual increases in exercise intensity and duration. Each weekly session will last 75 minutes. The fitness instructor will teach participants to use a table-top ergometer at a sub-maximal level, determine baseline fitness, and develop an individualized exercise prescription. The fitness instructor will provide educational tips on exercise and selection of physical activities. Participants will be given a pedometer and heart rate monitor to track their exercise at home. They will also be given an exercise DVD to use at home.
16147978|NCT01797237|Device|PFNA|
16147979|NCT01797237|Device|InterTAN|
16147980|NCT01797211|Dietary Supplement|Mediterranean diet|Patients underwent administration of Mediterranean diet and olive oil, or Mediterranean diet and not-fried fish, or Mediterranean diet and nuts.
16147981|NCT01797198|Drug|ASP3652|Oral
16147982|NCT01797198|Drug|Gemfibrozil|Oral
16147983|NCT01797198|Drug|Repaglinide|Oral
16147984|NCT01797185|Drug|SPARC1104 modified dose regimen I|Subjects who exited study CLR_09_21
16147985|NCT01797185|Drug|SPARC1104 modified dose regimen II|Subjects who received prior treatment regimen I
16147986|NCT01797185|Drug|SPARC1104 modified dose regimen III|Subjects who received no prior treatment regimen
16147987|NCT01797172|Procedure|Percutaneous Cervical Nucleoplasty|Cervical nucleoplasty is a method of percutaneous disc decompression using a 19 Gauge Trocar 3 inch spine needle (ArthroCare Co., Sunnyvale, CA, USA) which is brought to the annulus fibrosis of the herniated disc. If in the correct position, the stylet is withdrawn and the Perc DC SpineWand (ArthroCare Co., Sunnyvale, CA, USA) is introduced. The procedure relies on so-called Coblation technology which involves removing a portion of the nucleus tissue by using radio frequency energy. More specific, it results in ablation of a portion of nucleus tissue, not with heat, but with a low-temperature (typically 40-70° C) plasma field of ionized particles.
16147988|NCT01797172|Procedure|Pulsed Radio Frequency|Pulsed Radio Frequency involves placement of a needle close to the to-be-treated nerve or dorsal root ganglion (DRG). The position is checked radiographically and by motor and sensory nerve stimulation. When the needle has been placed correctly an electrode is introduced, which conducts short bursts of radio frequency energy to nervous tissue. It is known as a non- or minimally neurodestructive technique, alternative to radio frequency heat lesions using so-called thermocoagulation. No nerve damage takes places as the temperature of the tip of the needle does not exceed 42°C. This is achieved by relatively long pauses between pulses which allow generated heat to dissipate and prevent the development of any thermal lesion.
16147990|NCT01797146|Procedure|Catheter Reminder and Evaluation Program|"This intervention will be implemented by ward nurses and responsible physicians. The details of intervention are shown below.
~Nurse: Every morning, a ward nurse will check if any patient has a urinary catheter or a central venous catheter in place. An order sheet will be marked with a CARE-rubber stamp and the following information will be added by hand-writing.
~Type and duration of urinary catheter use.
~Indication of urinary catheter _________
~Type and duration of central venous catheter use
~Indication of urinary catheter _________
~Responsible physician: During a morning round, a physician needs to fill the indication of catheter use. If a given physician does not fill the indication of urinary catheter use, the catheter will be automatically removed. If a given physician does not fill the indication of central venous catheter, the CARE team will be notified."
16147991|NCT01797133|Procedure|ID fellow-based antibiotic pre-authorization|All prescriptions of controlled antibiotics (Piperacillin/Tazobactam, Imipenem/Cilastatin, Meropenem and Doripenem) can be freely prescribed for the first 72 hours. After that, the prescription requires approval. Antibiotic preauthorization program will be operated by ID-fellows, under the supervision of ID staffs.
16147992|NCT01797133|Procedure|Pharmacist-based antibiotic pre-authorization|All prescriptions of controlled antibiotics (Piperacillin/Tazobactam, Imipenem/Cilastatin, Meropenem and Doripenem) can be freely prescribed for the first 72 hours. After that, the prescription requires approval. Antibiotic preauthorization program will be operated by general pharmacists, under the supervision of ID staffs.
16147993|NCT01797120|Drug|Fulvestrant|"Fulvestrant 500 mg Day 1 & 15 of Cycle 1, then 500 mg Day 1 of all subsequent cycles (every 28 days for 12 cycles).
~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity."
16147994|NCT01797120|Drug|Everolimus|"Everolimus 10 mg (2 tablets) daily x 12 cycles.
~If no evidence of disease progression after 12 cycles, unblind and continue same dose and schedule until progression or unacceptable toxicity."
16147995|NCT01797120|Drug|Placebo|Placebo for Everolimus (2 tablets) daily x 12 cycles. Placebo manufactured to mimic everolimus tablet.
16147996|NCT01797107|Drug|Azasite|Patients will be given 1 drop twice a day for 2 days followed by 1 drop nightly for 4 weeks.
16147997|NCT01797094|Biological|botulinum toxin Type A (44U)|44 units botulinum toxin Type A (total dose) per treatment. 24 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area.
16147998|NCT01797094|Biological|botulinum toxin Type A (32U)|32 units botulinum toxin Type A (total dose) per treatment. 12 U injected into bilateral Crow's Feet Line areas and 20 U injected into Frown Line area.
16147999|NCT01797081|Biological|botulinum toxin Type A (24 U)|24 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas per treatment.
16148000|NCT01797081|Biological|botulinum toxin Type A (12 U)|12 units botulinum toxin Type A (total dose) injected into bilateral Crow's Feet Line areas per treatment.
16148001|NCT01797081|Other|Normal Saline|Normal saline (placebo) injected into bilateral Crow's Feet Line areas per treatment.
16148002|NCT01797068|Behavioral|Patient Navigator|Patients in the intervention group will be offered patient navigation and timely access to comprehensive care and services through Project Access-New Haven (PA-NH), a local non-profit organization that coordinates the provision of donated medical care and services to underserved patients through a network of participating hospitals and volunteer physicians.
16148003|NCT01797068|Other|Standard of Care|Patients in the standard of care group will experience the usual intake process in the ED setting.
16148004|NCT01797055|Drug|Human apotransferrin|intravenous infusion
16148071|NCT01796444|Procedure|Pathological Evaluation|H&E and IHC
16148264|NCT01795066|Device|EUS-FNB with 25-gauge (Echotip ProCore; Cook Endoscopy Inc, Limerick, Ireland)|
16148006|NCT01797029|Biological|SIIL Live Attenuated Influenza Vaccine|A single dose of SIIL Trivalent LAIV--2012/2013 Northern Hemisphere vaccine containing A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010
16148007|NCT01797029|Biological|Placebo|A single dose of inactive placebo will be identical to reconstituted SIIL LAIV in ingredients and concentrations except A/California/7/2009 (H1N1), A/Victoria/361/2011 (H3N2), B/Wisconsin/1/2010 will be replaced with egg allantoic fluid.
16148008|NCT01797003|Other|High tibial osteotomy|
16148009|NCT01796990|Behavioral|ACT|"The intervention program consists of six group sessions, about 90 minutes per session during the 9 weeks period of time. The group size is about 8-10 members per one group. All the participants get also pedometers for monitoring their physical activity during the intervention.
~The program aims to enhance physically active lifestyle and well-being through important life values and build committed action based on the chosen important things. The importance is also placed to a mindful awareness and flexibility to everyday actions related to physical activity. The program don´t include psycho-educational elements or counseling of the health or the health benefits of physical activity."
16148010|NCT01796990|Behavioral|REF|The participants will get written feedback about their physical activity level after the baseline, and after 3, 6, 9 and 15 months of baseline compared to the current physical activity recommendations. Feedback will be created to illustrate participants´ activity level during the measurement week combining also the information from the diary. Feedback will be posted home and don´t include face to face interaction. As an incentive for participation, participants will also have opportunity to attend a body composition analyze and get short interpretation (15 min) of their own results in the research center.
16148011|NCT01796977|Device|OxyGenesys Dissolved Oxygen Dressing|
16148012|NCT01796977|Device|Standard Gauze Dressing|
16148013|NCT01796964|Drug|ESBA1008 solution|For intravitreal (IVT) injection
16148014|NCT01796964|Drug|Aflibercept|For intravitreal (IVT) injection
16148015|NCT01796951|Drug|Aspirin 325 mg daily|In this single-arm trial, participants will take celecoxib 200 mg BID for 5 doses, followed by aspirin 325 mg daily for 10 days, followed by combination of celecoxib 200 mg BID for 5 doses and aspirin 325 mg daily for 3 days.
16148016|NCT01796951|Drug|Celecoxib 200 mg BID|In this single-arm trial, participants will take celecoxib 200 mg BID for 5 doses, followed by aspirin 325 mg daily for 10 days, followed by combination of celecoxib 200 mg BID for 5 doses and aspirin 325 mg daily for 3 days.
16148017|NCT01796938|Drug|Lacosamide tablet|Single dose of 100 mg Lacosamide tablet
16148018|NCT01796925|Device|aura6000 THN System|The aura6000 device is an implanted hypoglossal nerve stimulator designed to maintain wakeful muscle tone of the tongue during sleep. It is implanted through a short surgical procedure. The implant is programmed to provide the optimal stimulation parameters for the patient. The therapy is controlled by a hand-held remote control allowing the patient to start, stop, and pause the therapy during times of sleep.
16148019|NCT01796912|Other|Lipoprotein Apheresis|Weekly lipoprotein apheresis for 3 months
16148020|NCT01796912|Other|Sham Apheresis|Weekly sham (placebo) apheresis for 3 months
16148021|NCT01796899|Other|Brivaracetam 10 mg oral tablet|
16148022|NCT01796899|Other|Brivaracetam 50 mg oral tablet|
16148023|NCT01796899|Other|Brivaracetam 75 mg oral tablet|
16148024|NCT01796899|Other|Brivaracetam 100 mg oral tablet|
16148025|NCT01796899|Other|10 mL of Brivaracetam intravenous bolus injection (10 mg/mL)|
16148026|NCT01796886|Other|pupillometry data|
16148027|NCT01796860|Other|AFO|The purpose of this study is to investigate the impact of a specifically designed ankle foot orthosis (AFO, hinged, with tamarack joint and adjustable check strap) on the spatial and temporal gait parameters, electromyography (EMG), and walking endurance, in select individuals living with MS. Over the 13 week period, the subject will participate in 5 gait training sessions which will be at weeks 1, 2, 3, 7, and 10.
16148028|NCT01796834|Behavioral|Mindfulness-Based Stress Reduction (MBSR)|An 8-9 week MBSR course led by an experienced instructor in a group format. Participants learn mindfulness meditation techniques and simple yoga exercises. Subjects receive four phone support calls.
16148029|NCT01796821|Drug|Vehicle gel|"Clinical diagnosed lesion site(s): Topical application once daily with occlusive dressing.
~Clinical normal skin on treated area: Topical application thrice daily without occlusive dressing.
~Total application <1,500 mg gel per day."
16148030|NCT01796821|Drug|SR-T100 gel with 1.0 % SM|"Clinical diagnosed lesion site(s): Topical application once daily with occlusive dressing.
~Clinical normal skin on treated area: Topical application thrice daily without occlusive dressing.
~Total application <1,500 mg gel per day."
16148031|NCT01796821|Drug|SR-T100 gel with 2.3% SM|"Clinical diagnosed lesion site(s): Topical application once daily with occlusive dressing.
~Clinical normal skin on treated area: Topical application thrice daily without occlusive dressing.
~Total application <1,500 mg gel per day."
16148032|NCT01796808|Procedure|Pedal Fat Grafting|"Fat grafting is a minimally invasive clinical procedure that has been widely used by plastic surgeons within reconstructive surgery for many years and is considered a standard of care procedure in plastic surgery. Fat tissue to be used for grafting is harvested (usually from abdomen or thighs) with a small liposuction cannula. The fat tissue is then sterilely centrifuged and allowed to decant before separating the fluid and oil layers from the fat tissue fraction. The aspirated fat is then loaded into 1cc syringes and injected into the plantar fat pad using specialized injection cannulas.
~Postoperatively, the foot will be bandaged for twenty-four hours and the subject will be advised to limit ambulation. Over the next three weeks, the patient will be instructed to wear a cushioned, supportive sneaker and participate in only activities of normal daily living, with no excessive aerobic activity."
16148033|NCT01796808|Other|Local anesthetic|"To numb the foot for the fat grafting procedure, lidocaine with epinephrine will be used. This will be injected near the posterior tibial nerve to numb the bottom of the foot.
~Local anesthetic of lidocaine with epinephrine will also be used to numb the fat graft harvest site (i.e. abdomen or thigh). This will allow a small incision to make so that tumescent solution can be injected into the area of fat graft harvest. Tumescent solution is a combination of injectible saline, epinephrine and lidocaine that causes numbness and vasoconstriction in the area where the fat will be harvested. This limits pain and bruising during the procedures. Only a very small amount of tumescent should be needed (i.e. <200ml). Only a few cc's of fat are needed for injection into the foot."
16148229|NCT01795313|Biological|HLA-A2 restricted synthetic tumor antigen|
16148230|NCT01795313|Drug|Imiquimod|
16148034|NCT01796795|Drug|Vehicle gel|Topical application on the target lesion(s)once daily with occlusive dressing; a maximum of 3 times of administration of gel without exceeding 0.2 g per administration.
16148035|NCT01796795|Drug|SR-T100 gel with 1.0% of SM|Topical application on the target lesion(s)once daily with occlusive dressing; a maximum of 3 times of administration of gel without exceeding 0.2 g per administration.
16148036|NCT01796795|Drug|SR-T100 gel with 2.3% of SM|Topical application on the target lesion(s)once daily with occlusive dressing; a maximum of 3 times of administration of gel without exceeding 0.2 g per administration.
16148037|NCT01796782|Drug|Xeloda|Xeloda dose is calculated according to body surface area.The recommended dose is 1000 mg/m² administered orally twice daily (morning and evening; equivalent to 2000 mg/m² total daily dose) for 2 weeks followed by a 1-week rest period given as 3-week cycles
16148038|NCT01796782|Drug|QYHJ Granules|1-4 bags bid , days 1-42, every 6 weeks
16148039|NCT01796769|Device|Continuous Positive Airway Pressure (CPAP) in sleep apnea patients|Usual CPAP treatment in sleep apnea patients
16148040|NCT01796769|Device|Continuous Positive Airway Pressure (CPAP) in sleep apnea patients|CPAP treatment with telemedicine system
16148041|NCT01796756|Other|Handover program|
16148042|NCT01796730|Drug|bambuterol|Patients will be randomized allocated to receive three treatment sequences I, II and III, every treatment period is separated by a washout period of 7 days.
16148043|NCT01796730|Drug|Placebo|
16148044|NCT01796717|Drug|C Group|Controlled group will receive piperacillin/tazobactam of 4.5g Q6h, intermittent infusion for 30 minutes
16148045|NCT01796717|Drug|E Group|Therapy group will receive piperacillin/tazobactam of 4.5g Q6h, prolonged infusion for 4 hours
16148046|NCT01796678|Drug|Arginine|
16148047|NCT01796678|Drug|Placebo|Saline or Sugar pill was given as placebo
16148051|NCT01796626|Device|M22 ResurFX module|The system delivers pulsed near Infra-Red (NIR) laser light with a nominal wavelength of 1565 nm and has a unique treatment handpiece with epidermal cooling. The clinician is able to control the settings of energy, µBeams density, scan size, and shape option from the user interface (LCD GUI) display on the main M22 console.
16148052|NCT01796613|Device|Vaginal Ring - intermittent regimen|NuvaRing® used intermittently. Nuvaring is a contraceptive vaginal ring, manufactured by N.V. Organon (a subsidiary of Merck & Co., Inc.,), Oss, the Netherlands. It contains 11.7 mg etonogestrel and 2.7 mg ethinylestradiol. It releases etonogestrel and ethinylestradiol at an average amount of 0.120 mg and 0.015 mg, respectively per 24 hours, over a period of 3 weeks. It is approved since 2001 by most countries within the European Union, and in the United Stated by the FDA.
16148053|NCT01796613|Device|Vaginal Ring - continuous regimen|NuvaRing® used continuously. Nuvaring is a contraceptive vaginal ring, manufactured by N.V. Organon (a subsidiary of Merck & Co., Inc.,), Oss, the Netherlands. It contains 11.7 mg etonogestrel and 2.7 mg ethinylestradiol. It releases etonogestrel and ethinylestradiol at an average amount of 0.120 mg and 0.015 mg, respectively per 24 hours, over a period of 3 weeks. It is approved since 2001 by most countries within the European Union, and in the United Stated by the FDA.
16148054|NCT01796600|Device|The patients will have a conventional scanner, a reference examination, and a cone-beam scanner Newtom 5G just after the conventional scanner|
16148055|NCT01796587|Device|LoFric Origo|
16148056|NCT01796574|Dietary Supplement|Ketogenic diet|4:1 ratio fat: carbohydrates and protein ketogenic liquid via enteral feed
16148057|NCT01796561|Dietary Supplement|Olive leaf extract liquid|Commercially available polyphenol-rich olive leaf extract liquid
16148058|NCT01796548|Drug|Oxybutinin Extended-Release|Oxybutynin chloride 5, 10, 15 milligram (mg) per tablet 10-30 mg per day orally
16148059|NCT01796522|Drug|progesterone 200 mg / day vaginally|
16148060|NCT01796522|Drug|nifedipine (60 mg / day orally)|
16148061|NCT01796509|Other|Medical, psychological, social|After having given his consent, the patient filled auto questionnaire, and then randomized either in follow up arm (i.e. intervention group) or in no follow up arm (i.e. control group). In the follow up arm, medical, psychological and social consultation will be planned within the first seven days after inclusion, and then 3, 6, 12 months. During medical consultation a general examination will be performed, muscle strength, cognitive function, functional disabilities will be assessed with help of MRC, MMS. During psychological consultation, anxiety and depression will be assessed with the help of HAD, IES. The psychologist will also have a free interview. During social consultation personal and professional reinsertion will be assessed.
16148062|NCT01796496|Other|Manipulative Therapy Techniques|"Global Technical bilateral pelvis: The technique involves inserting a small spine rotation and make a slack in three stages.
~Indirect technique of lumbar roll in rotation for bilateral L3: to reduce the slack and make the body drop simultaneously, together with a high speed contraction pectoral muscles and triceps, iliac crest leading caudad which produces a rotation of the vertebra underlying joint space opening.
~Dog-technic on D12: this technique reduces the slack in the abdomen toward the hand in contact with D12. Next, the therapist conducted a thrust in the direction of the reduction."
16148063|NCT01796496|Other|Functional Technique|The therapist presses the two anterior superior iliac spines to open the back of the pelvis, this maintained throughout the technique. Then patient is asked to breathe deeply and exhale, sacrum makes a flexion-extension respectively. These movements should be symmetrical and of equal duration in time.
16148064|NCT01796483|Device|Clonidine (Catapressan)|Clonidine (Catapressan) : Oral administration - Single dose (150 µg) - 90 minutes before EEG
16148065|NCT01796483|Device|Placebo 90 minutes before EEG|Placebo : Oral administration - Single dose (lactose) - 90 minutes before EEG
16148066|NCT01796470|Drug|Entospletinib|Entospletinib tablets administered orally twice daily
16148067|NCT01796470|Drug|Idelalisib|Idelalisib tablets administered orally twice daily
16148068|NCT01796444|Procedure|Sentinel Lymph Node Biopsy|Sentinel lymph nodes are identified with the combining use of intraoperative gamma detector and/or blue dye.
16148069|NCT01796444|Procedure|Intraoperative Pathological Examination|touch imprint cytology and/or frozen section and/or OSNA
16148070|NCT01796444|Procedure|Axillary Lymph Node Dissection|Axillary lymph node dissection involving removal of at least level I and II nodes.
16148072|NCT01796444|Drug|Adjuvant Systemic Therapy|Adjuvant systemic therapy was determined by the treating physician according to the recently NCCN.
16148073|NCT01796444|Radiation|Radiation Therapy|Whole-breast opposing tangential-field radiation therapy.
16148074|NCT01796431|Drug|Eviplera®|
16148075|NCT01796418|Drug|Beraprost sodium|
16148076|NCT01796405|Drug|Clofarabine|
16148077|NCT01796392|Device|EBV|This study arm will undergo EBV treatment and also receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
16148078|NCT01796392|Other|Optimal Medical Management|This study arm will receive optimal medical management, including smoking cessation program support, pulmonary rehabilitation, usual medications and oxygen supplementation as necessary.
16148079|NCT01796379|Behavioral|High Intensity Interval Training|9 months of high intensity interval based aerobic exercise (3 times/week)
16148080|NCT01796379|Behavioral|Moderate Training|
16148081|NCT01796366|Drug|insulin 338 (GIPET I)|Each subject will be allocated to one of three dosing periods only. The subject will receive oral insulin 338 and placebo, administered subcutaneously (s.c., under the skin) once daily for 10 days at fixed dose levels.
16148082|NCT01796366|Drug|placebo|S.c placebo administered in combination with insulin 338
16148083|NCT01796366|Drug|insulin glargine|Each subject will be allocated to one of three dosing periods only. The subject will receive insulin glargine for s.c. administration and oral placebo once daily for 10 days at fixed dose levels.
16148084|NCT01796366|Drug|placebo|Oral placebo administered in combination with s.c. insulin glargine
16148085|NCT01796353|Other|sexual rehabilitation|exercise plus psycho-education
16148086|NCT01796353|Other|Usual care|usual care
16148087|NCT01796340|Behavioral|Food cue exposure|Participants will be exposed to several kinds of their favorite food. The aim of this exposure is to increase the food cravings as much as possible.
16148088|NCT01796340|Behavioral|Psycho-education|General information about nutrients, calories, exercise and the energy balance will be provided. In addition, psychological problems that accompany overweight will be discussed.
16148089|NCT01796327|Drug|dacomitinib oral|Dacomitinib 45 mg oral tablet
16148090|NCT01796327|Drug|dacomitinib intravenous|Dacomitinib 20 mg solution will be given as 1 hour intravenous infusion
16148091|NCT01796314|Behavioral|Therapeutic Educational Program|"The intervention is a therapeutic educational programme as recommended in the care of Alzheimer's disease. It includes two consultations for the dyad AD patient/caregiver and four group sessions, one a week, for caregivers only. The intervention length is 2 months.
~These collective sessions focus on :
~Knowledge of the disease
~Pharmacological and non pharmacological treatments. Behavioural and psychological symptoms of dementia
~Crisis situations. Prevention of caregiver's exhaustion
~Assistive devices and care pathways.
~Monitoring will consist of a two consultations to 6 and 12 months including assessment of secondary outcome measures."
16148092|NCT01796301|Drug|Romozosumab|Administered by subcutaneous injection once a month.
16148093|NCT01796301|Drug|Teriparatide|Administered by subcutaneous injection once a day.
16148094|NCT01796288|Radiation|simultaneous radiotherapy|
16148095|NCT01796288|Drug|Erlotinib|
16148096|NCT01796275|Behavioral|Core intervention program|
16148097|NCT01796275|Behavioral|Booster session|
16148098|NCT01796275|Behavioral|Control only (Tea gathering)|
16148099|NCT01796262|Dietary Supplement|docosahexaenoic acid|Supplementation with DHA Richoil 250mg pearl b.i.d. for six months
16148100|NCT01796262|Dietary Supplement|Wheat germ oil|Wheat germ oil 250 mg pearl b.i.d. for six months
16148101|NCT01796236|Device|Minimally invasive surgery and BA400|The Cochlear Baha BA400 Abutment has been designed with a concave shape at the lower aspect of the abutment. The abutment is made of commercially pure titanium and is coated with a hydroxyapatite layer on the entire soft tissue-contacting surface of the abutment up to 3 mm below the top surface (2 mm below the top surface on 6 mm abutments).
16148102|NCT01796236|Device|Traditional surgery and BA300|The BA300 abutment is made of commercially pure titanium and is available in two different lengths (6 mm and 9 mm).
16148103|NCT01796223|Behavioral|Feedback|The Partners for Change Outcome Management System, administered at the beginning and ending of every therapy session.
16148104|NCT01796223|Behavioral|Control|
16148105|NCT01796197|Drug|Trastuzumab|
16148106|NCT01796197|Drug|Pertuzumab|
16148107|NCT01796197|Drug|Paclitaxel|
16148108|NCT01796197|Drug|Doxorubicin|
16148109|NCT01796197|Drug|Cyclophosphamide|
16148110|NCT01796197|Procedure|Mastectomy|
16148111|NCT01796197|Radiation|Radiation Therapy|
16148112|NCT01796171|Drug|Betalutin|Betalutin, 10 MBq/kg b.w. in escalated doses with 40 mg lilotomab pre-dosing
16148113|NCT01796171|Drug|Betalutin|Betalutin, 15 MBq/kg b.w. in escalated doses without pre-dosing
16148114|NCT01796171|Drug|Betalutin|Betalutin, 15 MBq/kg b.w. in escalated doses with rituximab pre-dosing
16148115|NCT01796171|Drug|Betalutin|Betalutin, 15 MBq/kg b.w. in escalated doses with 100 mg/m2 lilotomab pre-dosing
16148116|NCT01796171|Drug|Betalutin|Betalutin, 20 MBq/kg b.w. in escalated doses with 60 mg/m2 lilotomab pre-dosing
16148117|NCT01796171|Drug|Betalutin|Betalutin, 15 MBq/kg b.w. with 40mg lilotomab
16148118|NCT01796158|Behavioral|cASBI+cMET|In the cASBI protocol participants complete a computerized screen for alcohol and drug use, view their screen results on the computer, then see 10 pages of science and true life stories describing the health effects of alcohol and other substance use. The provider receives a report of the screen results and gives brief advice regarding alcohol and drug use during the office visit. The cMET protocol is a 2 session intervention composed of 8 exercises designed to encourage adolescents their alcohol and other substance use and develop a plan to stop or reduce their use.
16148119|NCT01796158|Behavioral|cASBI|In the cASBI protocol participants complete a computerized screen for alcohol and drug use, view their screen results on the computer, then see 10 pages of science and true life stories describing the health effects of alcohol and other substance use. The provider receives a report of the screen results and gives brief advice regarding alcohol and drug use during the office visit.
16148120|NCT01796145|Other|Fibroscan|
16148231|NCT01795313|Other|enzyme-linked immunosorbent assay|
16148232|NCT01795313|Other|flow cytometry|
16148121|NCT01796132|Drug|SSRI/SNRI|Exposed group of mothers taking one of the mentioned antidepressant drugs of the class of selective serotonin reuptake inhibitors (SSRI) or serotonin/noradrenalin reuptake inhibitors (SNRI).
16148122|NCT01796119|Procedure|Ridge Splitting|"To measure the horizontal bone width before and after implant insertion and 6 months post-op.
~To measure BLI measured using PA radiographs taken immediately and 6 months post-op.
~To measure implant stability with the resonance frequency analyzer (Osstell,Osstell USA) at time of implant placement, 3 months and 6 months post-op.
~To measure implant success rate. The implants used in this study: NobelActive 3.5 - 4.3mm diameter, 10 - 13 mm in length."
16148123|NCT01796119|Procedure|Implants placed using drilling technique|"To measure the horizontal bone width before and after implant insertion and 6 months post-op.
~To measure BLI measured using PA radiographs taken immediately and 6 months post-op.
~To measure implant stability with the resonance frequency analyzer (Osstell,Osstell USA) at time of implant placement, 3 months and 6 months post-op.
~To measure implant success rate. The implants used in this study: NobelActive 3.5-4.3mm diameter, 10 - 13 mm in length."
16148124|NCT01796106|Device|Icon|refer to instructions for use of Icon
16148125|NCT01796106|Device|fluoride varnish|The study clinician will provide oral hygiene instruction and topical fluoridation therapy (Duraphat fluoride varnish; Colgate Oral Pharmaceuticals, New York, NY, United States) to all study participants randomized to study arm 2 after the radiograph and visual exam. Topical fluoridation treatment will be provided is varnish (Duraphat) per manufacturer's instructions.
16148126|NCT01796093|Drug|Digoxin and ivabradine|No more details
16148127|NCT01796080|Other|Mueller manoeuvre|
16148128|NCT01796080|Other|Inspiratory threshold|
16148129|NCT01796080|Other|Expiratory apnoea|
16148130|NCT01796080|Other|Steady state normal breathing|
16148131|NCT01796067|Behavioral|Motivational and Family Weight Loss|This group will receive the comprehensive motivational and family weight loss intervention.
16148132|NCT01796067|Behavioral|Basic Health Education|This group will receive the comprehensive basic health education intervention.
16148133|NCT01796067|Behavioral|Online Intervention|Participants will receive the online tailored weight loss intervention program after they have either received the motivational plus family weight loss program or basic health face-to-face program.
16148134|NCT01796067|Behavioral|Online Control|Participants will receive the online control program after they have either received the motivational plus family weight loss program or the basic health education program.
16148135|NCT01796054|Behavioral|Stress Free Now online program|Stress Free Now is an online stress reduction program. Participants will log into online program, read and practice daily and weekly activities.
16148136|NCT01796054|Behavioral|Group support session|Participants will meet weekly for group support session to review online lessons and relaxation therapies.
16148137|NCT01796041|Drug|Indocyanine Green|
16148138|NCT01796028|Drug|METFORMIN|
16148139|NCT01796028|Drug|Placebo|
16148140|NCT01796028|Drug|TAXOTERE®|
16148141|NCT01796015|Other|ONSD ultrasound|"Description of the ONSD ultrasound: ONSD is measured 3 mm behind the globe and perpendicularly to the optic nerve axis (2 dimensions mode).
~For each optic nerve, 2 measures are performed: 1 sagittal and 1 transverse. The patient is positioned in 30° dorsal elevation. Gel is applied on the eyelid and a 7,5 MHz probe is used.
~At the same time and on the same side, a transcranial Doppler is performed using a 2 MHz probe placed on the temple. Are measured: systolic velocity, mean velocity, diastolic velocity, resistance index and pulsatility index.
~As ONSD measures cannot be done blinded (regarding ICP monitoring), a centralised evaluation (by 2 experts) of the recorded sonograms is planned."
16148142|NCT01796002|Drug|Romidepsin + CHOP|Ro-CHOP administered in 3 week cycles for 6 cycles or until progression Romidepsin is administered at a dose of 12 mg/m² IV on day 1 and day 8 every 3 weeks.
16148143|NCT01796002|Drug|CHOP|CHOP (cyclophosphamide, doxorubicin, vincristine and prednisone) administered in 3 week cycles for 6 cycles.
16148144|NCT01795989|Device|1.5T MRI Elbow Coil|Pediatric coil for musculoskeletal imaging at 1.5 Tesla for pediatric patients and healthy participants.
16148145|NCT01795976|Genetic|NY-ESO-1 T cells|
16148146|NCT01795976|Drug|cyclophosphamide|cyclophosphamide 60mg/kg/day day -7 and day -6
16148147|NCT01795976|Drug|Fludarabine|Fludarabine given 25mg/m2 day -5 to day -1
16148148|NCT01795976|Biological|Interleukin 2|Interleukin 2 (IL2) immunotherapy given day 0 to day 6
16148149|NCT01795963|Behavioral|ePREP|The ePREP intervention teaches individuals how to recognize and combat dynamic risk factors that lead to relationship distress. Specifically, it teaches communication techniques and problem-solving skills that help couples to effectively deal with conflict. It also teaches couples how to enhance positive aspects of their relationship by fostering fun and friendship.
16148150|NCT01795963|Behavioral|Placebo Control|Participants in the control condition will view a presentation that teaches inert information about anxiety, depression, and relationships such as definitions, prevalence rates, common problems associated with these conditions and available forms of treatment. This presentation was used initially in Cuckrowicz & Joiner (2007) and has since been shown to be effective as a placebo in two previous ePREP studies (Braithwaite & Fincham, 2007; Braithwaite & Fincham, 2008). This presentation is identical to the ePREP intervention in its set up, the only difference being, there is no information included in this presentation that teaches specific skills or strategies for improving relationships, depression or anxiety.
16148151|NCT01795950|Drug|PLX-PAD|intravenous administration of a single dose of PLX-PAD cells
16148152|NCT01795937|Drug|Itraconazole|twice daily
16148153|NCT01795937|Drug|Atorvastatin|single dose
16148154|NCT01795937|Drug|Faldaprevir|once daily
16148155|NCT01795937|Drug|Rosuvastatin|single dose
16148156|NCT01795937|Drug|Faldaprevir|once daily
16148157|NCT01795924|Drug|PD-616|Patients may continue treatment through 1 year post-C1D1 or until withdrawal of consent or development of any toxicity meeting the definition of Dose-Limiting Toxicity or progressive disease, whichever occurs first.
16148158|NCT01795911|Biological|Pegylated Interferon Lambda|
16148159|NCT01795911|Drug|Ribasphere|
16148160|NCT01795911|Drug|Daclatasvir|
16148161|NCT01795898|Drug|Fentanyl|Fentanyl transdermal patches releasing 12.5 microgram of fentanyl will be applied for 3 days. The patches will be replaced every 3 days (Day 3, 7 and 10).
16148233|NCT01795313|Other|immunohistochemistry staining method|
16148162|NCT01795885|Behavioral|16 and Pregnant|"Participants in this arm will be asked to watch an approximately 45-minute commercial-free episode of the MTV television show 16 and Pregnant once a week for 4 weeks. They will receive an email that contains a link to watch an episode of the show on the internet. The site where the videos are hosted is password protected and they are given the password in the same email. They can watch the video at any time, and can come back to it later if they need to stop watching it. The participants are asked to all watch the same episode each week. Four episodes were selected for the intervention from the first three seasons of the show."
16148163|NCT01795872|Procedure|Several diagnostic procedures|No drug will be assigned, diagnostic assessment within the study.
16148164|NCT01795859|Drug|SD-809|SD-809 tablets are available in three dose strengths: 6, 9 and 12 mg, all of which are identical in size, shape and color (white).
16148165|NCT01795859|Drug|Placebo|Placebo tablets are identical in appearance to SD-809 tablets.
16148166|NCT01795846|Other|Allergen specific immunotherapy and placebo injections|
16148167|NCT01795833|Other|Short text messages|In addition to structured education on healthy lifestyle provided at baseline, subjects in the arm will receive short text messages containing educational, motivational and supportive content on diet, physical activity, and smoking (if appropriate) during the study period. The content will be appropriate to the stage of the transtheoretical model of behavioural change that the subject is in. This will be assessed by questionnaire at each visit to clinic.
16148168|NCT01795820|Drug|loading with Ticagrelor|Patients allocated in the two study arms will receive the same anti platelet treatment, except for the administration of the loading dose, which will be only administered to patients allocated in Group 2
16148169|NCT01795820|Drug|no loading with Ticagrelor|"Patients allocated in the two study arms will receive the same anti platelet treatment, except for the administration of the loading dose, which will be only administered to patients allocated in Group 2.
~In other words, patients randomized to this group (group 1) will not receive a loading dose of ticagrelor during the passage from clopidogrel to ticagrelor."
16148170|NCT01795794|Drug|omeprazole|
16148171|NCT01795768|Drug|AZD 4547|
16148172|NCT01795755|Behavioral|Mentalization based inpatient treatment.|1-3 month of inpatient treatment
16148173|NCT01795755|Behavioral|Horse assisted Therapy (HAT)|A structured program of 12 X 90 minute HAT sessions (horse care, ground and mounted work) conducted by two clinically qualified therapists who are also Level I Riding Instructors.
16148174|NCT01795742|Device|Human-Powered Nebulizer|
16148175|NCT01795729|Device|Stent|Coronary revascularization
16148176|NCT01795729|Drug|optimal medical therapy|Dual antiplatelet therapy: aspirin and a P2Y12 inhibitor as indicated
16148177|NCT01795716|Drug|mesylate imatinib capsule|Single and multiple oral mesylate imatinib capsule 400mg qd
16148178|NCT01795716|Drug|Glivec|Single and multiple oral Glivec 400mg qd
16148179|NCT01795703|Drug|Abiraterone|Abiraterone will be administered orally as 1000 milligram (mg) per day for 28-daily dosing cycles which will be continued until disease progression or unacceptable toxicity.
16148180|NCT01795703|Drug|Prednisolone|Prednisolone will be administered orally as 5 mg tablets twice daily for 28-daily dosing cycle which will be continued until disease progression or unacceptable toxicity.
16148181|NCT01795677|Drug|Ruxolotinib|Ruxolotinib doses calculated with platelets count and P450 cytochrome inhibitor HSCT for patients with donor
16148182|NCT01795664|Radiation|Functional Respiratory Imaging|CT-scan of thorax, at visit 2 pre and postdose and at visit 3 pre and postdose
16148183|NCT01795664|Drug|Salmeterol xinafoate and Fluticasone propionate HFA pMDI|"Strength: 25/250 mcg per actuation; Dose: single dose of 2 puffs; A total dose of 50/500 mcg
~At visit 2 or visit 3 (cross-over design)"
16148184|NCT01795664|Drug|Seretide Evohaler|"Strength: 25/250 mcg per actuation; Dose: single dose of 2 puffs; A total dose of 50/500 mcg
~At visit 2 or visit 3 (cross-over design)"
16148185|NCT01795664|Drug|Placebo of Test product|"Single dose of 2 puffs
~To ensure blinding, each patient will receive two inhalers (one active and one placebo) on each dosing day."
16148186|NCT01795664|Drug|Placebo of Reference product|"Single dose of 2 puffs
~To ensure blinding, each patient will receive two inhalers (one active and one placebo) on each dosing day."
16148187|NCT01795651|Procedure|identification of take-home message of lecture|
16148188|NCT01795638|Drug|Sodium chloride|
16148189|NCT01795638|Drug|Placebo|sterile water, 0.4 ml/kg every 6 hours on days of life 7-35.
16148190|NCT01795612|Other|physical activity|
16148191|NCT01795599|Drug|Mifegyne ®|
16148192|NCT01795599|Drug|Gymiso®|
16148193|NCT01795586|Drug|Eribulin|"Eribulin will be administered on days 1 and 8 slow IV push over 2 to 5 minutes. Premedications will be given per institutional guidelines.
~Level 1: 0.9 mg/m^2; Level 2: 1.1 mg/m^2; Level 3: 1.4 mg/m^2"
16148194|NCT01795586|Drug|Carboplatin|Carboplatin will be administered intravenously on day 1 and day 8 of each cycle, immediately following eribulin infusion at a dose of area-under-the-curve (AUC) 2 over 30 minutes in 250 ML of 0.9 % normal saline. Carboplatin dose will be calculated using the Calvert formula using AUC of 2 as follows: Carboplatin dose (mg) = 2 X (GFR + 25).
16148195|NCT01795573|Biological|Cultured Treg cells|Co-culturing of recipient dendritic cells and donor Treg. Treg administration will occur 2 days before the allogeneic stem cell transplant (i.e. day -2 with reference of day 0 as stem cell infusion date).
16148196|NCT01795547|Drug|Aripiprazole and aripiprazole once-monthly|Oral aripiprazole tablets according to Summary of Product Characteristics (SmPC)/United States Prescription Information (USPI) daily for 4 weeks followed by the 1st aripiprazole intramuscular (IM) injection at the end of Week 4. Oral tablets were taken for 2 more weeks after the 1st injection. Starting at the end of Week 8, additional injections were given every 4 weeks until Week 24.
16148197|NCT01795547|Drug|Paliperidone and paliperidone palmitate|Oral paliperidone tablets according to SmPC/USPI daily for 3 weeks followed by 2 paliperidone palmitate IM injections at Weeks 3 and 4, respectively. Starting at the end of Week 8, additional injections were given every 4 weeks until Week 24.
16148198|NCT01795534|Dietary Supplement|Beetroot shot then placebo shot|Beetroot shot, four day wash out, then placebo shot
16148199|NCT01795534|Dietary Supplement|Placebo shot then beetroot shot|Placebo shot, four day wash out, then beetroot shot
16148234|NCT01795313|Other|laboratory biomarker analysis|
16148373|NCT01794260|Drug|Cream from Zingiber cassumunar Roxb. extract|
16148200|NCT01795521|Radiation|Stereotactic Body Radiotherapy (SBRT)|A form of radiation therapy, where only the primary tumor is targeted and precise stereotactic tumor localization combined with techniques reducing breathing- induced target motion allowed small safety margins. These small volumes are treated with hypo-fractionated, escalated irradiation doses. It's now further developed in multiple clinical and technological aspects e.g. FDG-PET/CT based nodal staging, respiration correlated CT- imaging for target volume definition and image-guided treatment delivery.
16148201|NCT01795508|Behavioral|PMTO|Parent Management Training, Oregon
16148202|NCT01795508|Behavioral|TAU|Other kinds of family training
16148203|NCT01795495|Drug|Methadone hydrochloride|This drug will be used in conjunction with remifentanil as an adjunct analgesic. Remifentanil + methadone (0.1 mg/kg IV over 15 minutes) just after induction of anesthesia
16148204|NCT01795495|Drug|Magnesium Sulfate|This drug will be given with remifentanil as an adjunct analgesic. Remifentanil + magnesium (50 mg/kg bolus over 30 minutes followed by 10 mg/kg/hour).
16148205|NCT01795495|Drug|Remifentanil|
16148206|NCT01795482|Device|Forced-air warming|In the intervention groups a forced-air cover (Level 1 Snuggle Warm Upper Body Blanket, Smiths Medicals) will be positioned over the patients sitting or laying on the operating table for 15 min before start of epidural anaesthesia and afterwards till start of general anaesthesia (group 3), for 15 min before start of general anaesthesia (group 2) or only after induction of general anaesthesia (group 1, control). All patients will receive forced-air warming after induction of general anaesthesia till end of surgery.
16148207|NCT01795469|Device|Zoex compression garment|5-strap compression of abdomen, thighs and legs
16148208|NCT01795443|Other|Calibration|"Subjects will be seated on a table, feet dangling, blindfolded, arms crossed over the chest and held in place by bandages to minimize the visual and proprioceptive inputs that may contribute to the realization of the task.
~The investigator uses an electronic goniometer to measure the maximal extension and flexion during a pelvic pivot. These measures will be used to determine a target position midway along the pelvic movement range."
16148209|NCT01795443|Other|Practice|"Propioception test: The movement required is flexion - extension of the lumbar spine without moving the shoulders; it is a pelvic rocking motion. The patients will be helped to the target position by the investigator. After keeping the target position for 5 seconds, they will be asked to completely pivot the pelvis to a forward position, then return to the target position.
~Each subject will have three (non-measured) tries at the proprioception test without vibration, then three tries with low frequency vibration (20 Hertz), and then three tries with high frequency vibration (60 Hertz). Between each series of tries, a 2-minute rest period with walking is required."
16148210|NCT01795443|Other|Measures - no vibration|"The movements required are performed without vibration.
~The movement required is flexion - extension of the lumbar spine without moving the shoulders; it is a pelvic rocking motion. The patients will be helped to the target position by the investigator. After keeping the target position for 5 seconds, they will be asked to completely pivot the pelvis to a forward position, then return to the target position. This test is repeated five times.
~The investigator measures the lumbar angle using an electronic goniometer twice during each of the five tests: once after the patient is helped to the target angle, and once after the patient tries to remember the target angle by his/herself."
16148211|NCT01795443|Other|Measures - low vibration|"The movements required are performed with low frequency vibration (20 Hertz on following device: VIBRALGIC 5; manufacturer = Electronique Conseil).
~The movement required is flexion - extension of the lumbar spine without moving the shoulders; it is a pelvic rocking motion. The patients will be helped to the target position by the investigator. After keeping the target position for 5 seconds, they will be asked to completely pivot the pelvis to a forward position, then return to the target position. This test is repeated five times.
~The investigator measures the lumbar angle using an electronic goniometer twice during each of the five tests: once after the patient is helped to the target angle, and once after the patient tries to remember the target angle by his/herself."
16148212|NCT01795443|Other|Measures - high vibration|"The movements required are performed with low frequency vibration (20 Hertz on following device: VIBRALGIC 5; manufacturer = Electronique Conseil).
~The movement required is flexion - extension of the lumbar spine without moving the shoulders; it is a pelvic rocking motion. The patients will be helped to the target position by the investigator. After keeping the target position for 5 seconds, they will be asked to completely pivot the pelvis to a forward position, then return to the target position. This test is repeated five times.
~The investigator measures the lumbar angle using an electronic goniometer twice during each of the five tests: once after the patient is helped to the target angle, and once after the patient tries to remember the target angle by his/herself."
16148213|NCT01795430|Drug|etoposide|Given IV
16148214|NCT01795430|Drug|ifosfamide|Given IV
16148215|NCT01795430|Radiation|intensity-modulated radiation therapy|Undergo WB-MRI-guided IMRT
16148216|NCT01795430|Drug|topotecan hydrochloride|Given IV
16148217|NCT01795430|Drug|busulfan|Given IV
16148218|NCT01795430|Drug|melphalan|Given IV
16148219|NCT01795430|Procedure|autologous hematopoietic stem cell transplantation|Undergo autologous peripheral blood stem cell or bone marrow transplant
16148220|NCT01795430|Procedure|peripheral blood stem cell transplantation|Undergo autologous peripheral blood stem cell transplant
16148221|NCT01795430|Procedure|autologous bone marrow transplantation|Undergo autologous bone marrow transplant
16148222|NCT01795417|Device|RF XP200|Four weekly non-invasive periorbital wrinkles treatment with RF XP200 device
16148223|NCT01795417|Device|XP200 RF device|4 RF treatments of periorbital region on one side of the face
16148224|NCT01795404|Behavioral|Inquiry Based Stress Reduction (IBSR)|
16148225|NCT01795378|Biological|donor natural killer cell infusion|"Donor NK cells will be generated at the GCP laboratory at Asan Institute of Life Science by a team from Stem Cell Research Center, Korea Research Institute of Bioscience and Biotechnology.
~The patients will receive donor NK cell infusion (DNKI) around on days 6 and 9 (generated from the first collection), and around on days 13 and 20 (generated from the second collection).
~For DNKI to be given on days 6 and 9, a 3-patient cohort each will receive escalating dose of 2x10e7/kg, 5x10e7/kg, 1x10e8/kg, and 1-4 x10e8 cells.
~The dose of DNKI to be given on days 13 and 20 will be 1-4 x10e8/kg."
16148226|NCT01795365|Other|Active surveillance|
16148227|NCT01795339|Drug|AZD3293|Oral solution
16148228|NCT01795339|Drug|Placebo|Oral solution
16148374|NCT01794260|Drug|Placebo cream|
16148235|NCT01795300|Radiation|Carbon Ion Radiotherapy|"Patients will be immobilized using an individually manufactured head mask for treatment planning and RT. Contrast-enhanced CT as well as MR-imaging will be performed for target volume definition. OAR such as the brain stem, optic nerves, chiasm and spinal chord will be contoured. The fractionation scheme will be taken into account for dose prescription, as well as DVH-characteristics and clinical parameters of the invidivual patient.
~The Gross Tumor Volume (GTV) will be defined as the contrast-enhancing lesion on MRI on T1-weighted MR-imaging. Amino-Acid-PET or DOTATOC-PET may be used in addition to contrast-enhanced MRI for target volume definition but is not mandatory.The Clinical Target Volume (CTV) will be defined adding 1-2mm safety margin to the GTV."
16148236|NCT01795300|Radiation|Proton Therapy|"As described previously, patients will be immobilized using an individually manufactured head mask for treatment planning and RT. Contrast-enhanced CT as well as MR-imaging will be performed for target volume definition. OAR such as the brain stem, optic nerves, chiasm and spinal chord will be contoured. Dose constraints of normal tissue will be respected according to Emami et al. (33). The fractionation scheme will be taken into account for dose prescription, as well as DVH-characteristics and clinical parameters of the invidivual patient.
~The Gross Tumor Volume (GTV) will be defined as the contrast-enhancing lesion on MRI on T1-weighted MR-imaging. Amino-Acid-PET or DOTATOC-PET may be used in addition to contrast-enhanced MRI for target volume definition but is not mandatory.The Clinical Target Volume (CTV) will be defined adding 1-2mm safety margin to the GTV."
16148237|NCT01795300|Radiation|Hypofractionated Photon Radiotherapy|"Treatment Planning for Photon Radiotherapy will be performed using the Planning Systems available at the Department of Radiation Oncology in Heidelberg, Germany (including Masterplan/Nucletron, Virtuos-Konrad/Siemens, or Precisis/STP/Stryker-Leibinger, or the Tomotherapy Software). Carbon ion and proton RT planning is performed using the treatment planning software PT-Planning (Siemens, Erlangen, Germany) including biologic plan optimization. Biologically effective dose distributions will be calculated using the a/ß ratio for meningioma as well as for the endpoint late toxicity to the brain. Patient positioning prior to radiotherapy will be evaluated by comparison of x-rays to the DRRs. Set up deviations >3mm are corrected prior to radiotherapy.
~To the target volume defined for photon treatment, a total dose of 52.2 Gy E - 57.6 Gy E is applied in single fractions of 1.8Gy E. In the 3Gy E Photon arm, photon radiotherapy will be delivered to a total dose of 45 Gy E in 15 fractions."
16148238|NCT01795300|Radiation|Conventional Photon Radiotherapy|Treatment Planning for Photon Radiotherapy will be performed using the Planning Systems available at the Department of Radiation Oncology in Heidelberg, Germany (including Masterplan/Nucletron, Virtuos-Konrad/Siemens, or Precisis/STP/Stryker-Leibinger, or the Tomotherapy Software). Carbon ion and proton RT planning is performed using the treatment planning software PT-Planning (Siemens, Erlangen, Germany) including biologic plan optimization. Biologically effective dose distributions will be calculated using the a/ß ratio for meningioma as well as for the endpoint late toxicity to the brain. Patient positioning prior to radiotherapy will be evaluated by comparison of x-rays to the DRRs. Set up deviations >3mm are corrected prior to radiotherapy.
16148239|NCT01795287|Procedure|General anesthesia|GA will be inducted by fentanyl, propofol and rocuronium. GA will be maintained by sevofluran, fentanyl and rocuronium.
16148240|NCT01795287|Procedure|Spinal anesthesia|hyperbaric bupivacaine 10-15 mg i.t.
16148241|NCT01795274|Radiation|Carbon Ion Radiotherapy|Step 1 14 x 3 Gy E 42 Gy E Step 2: 15 x 3 Gy E 45 Gy E Step 3: 16 x 3 Gy E 49 Gy E Step 4: 17 x 3 Gy E 51 Gy E Step 5: 18 x 3 Gy E 54 Gy E
16148242|NCT01795248|Drug|Liraglutide|1.8 mg liraglutide
16148243|NCT01795248|Drug|Placebo|Liraglutide without the GLP-1 analogue
16148244|NCT01795235|Drug|Saline|Saline s.c.
16148245|NCT01795235|Drug|Glucagon|Glucagon s.c.
16148246|NCT01795235|Drug|Placebo|Sugar Pill
16148247|NCT01795235|Drug|Atenolol|Beta-1 receptor antagonist
16148248|NCT01795222|Drug|Midazolam|Dormire: Midazolam oral solution 2 mg/mL Sedative was administered with a syringe by the anaesthesiologist
16148249|NCT01795222|Drug|Placebo|Magistral formula prepared to match Dormire color and consistency, without active ingredients Placebo was administered the same way as midazolam
16148250|NCT01795209|Drug|Ranibizumab|"Loading dose: three monthly intravitreal injections of ranibizumab 0.5 mg
~Lucentis stop criteria: V/A ≥20/20 and complete disappearance of macular edema
~Retreatment: visual loss of 5 or more letter compared to previous visit"
16148251|NCT01795209|Device|Sham injection|"Three monthly sham injections followed by retreatment (sham injections) as needed
~Stop criteria: V/A ≥20/20 and complete disappearance of macular edema
~Retreatment: visual loss of 5 or more letter compared to previous visit"
16148252|NCT01795209|Procedure|Rescue laser|"In the Lucentis group: performed if BCVA < 20/40 or CFT ≥ 350um despite of 3 sessions of previous Lucenis injection from Month 6
~In the standard of care group: performed if BCVA < 20/40 or CFT ≥ 350um from Month 3"
16148253|NCT01795183|Drug|AMISULPRIDE|Pharmaceutical form: tablet Route of administration: oral
16148254|NCT01795170|Dietary Supplement|Lysine Restricted Diet|Daily lysine intake will be managed to maintain a plasma lysine level of 50-80 µmol/L (normal range: 52-196 µmol/L). Diet prescriptions will be based on international guidelines for glutaricaciduria type I, another inborn error of lysine catabolism. In order to meet the recommended daily protein intake (DRI) [23,24], the diet may include commercially available lysine-free amino acid formulas approved for use in conditions affecting lysine metabolism, as well as commercially available low-protein products based on the participant's taste.
16148255|NCT01795170|Drug|Pyridoxine|All participants will be on 15-30 mg/kg/day of pyridoxine therapy up to a maximum of 500mg/day divided in 2-3 doses enterally
16148256|NCT01795157|Device|CCADSS|Questionnaire is transferred wireless to the physician's PC
16148257|NCT01795157|Device|pen-paper|Questionnaire completed and transferred to the physician using standard methods
16148258|NCT01795144|Drug|GLP-1|OGTT IGI IGI with GLP-1 infusion OGTT with Exendin 9-39 infusion
16148259|NCT01795144|Drug|Exendin 9-39|OGTT IGI IGI with GLP-1 infusion OGTT with Exendin 9-39 infusion
16148260|NCT01795131|Dietary Supplement|Vitamin B12|
16148261|NCT01795131|Dietary Supplement|Placebo|
16148262|NCT01795092|Other|Dermatology Consultation|A dermatology consultation will be conducted on patients randomized to this group.
16148263|NCT01795079|Device|Transcranial direct current stimulation (tDCS)|Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.
16148375|NCT01794247|Drug|Magnesium sulfate|
16148265|NCT01795053|Behavioral|Experimental: playtraining|playtraining is a play based intervention that includes techniques of behavioral management as: structuring of play situation, detailled play planning, definition of behavioral tasks, positive reinforcement, token economy. The intervention is designed to enhance play-persistence and -intensity and thereby reduce ADHD symptoms
16148266|NCT01795053|Behavioral|Placebo open play session|
16148267|NCT01795040|Dietary Supplement|omega-3/omega-6 fatty acids (PUFAs)|Equazen 500mg/day= 116 mg docosahexaenoic acid, 372 mg Eicosapentaenoic acid, 40 mg gamma-Linolenic acid
16148268|NCT01795027|Drug|S-1 plus oxaliplatin|6 courses chemotherapy with S-1 plus oxaliplatin followed by 10 courses S-1 single after d D2 resection
16148269|NCT01795027|Drug|S-1 single|16 courses S-1 single after d D2 resection
16148270|NCT01795001|Other|No intervention|
16148271|NCT01794988|Behavioral|Group Cognitive Behavioral Therapy|Each CBT session will last 90 minutes and will teach participants specific skills to better cope with chronic pain. These skills will include breathing exercises, distraction, and relaxation techniques.
16148272|NCT01794988|Behavioral|Pain Education|Subjects will receive mailed educational materials to their homes on a weekly basis. Weekly materials will contain information about the nature of chronic back pain, treatment options, exercises and stretching techniques for maintaining strength and flexibility, and proper protection for a healthy back. Pain education is the standard of care for most outpatient clinics.
16148273|NCT01794988|Behavioral|Therapeutic Interactive Voice Response|Therapeutic Interactive Voice Response as a daily self monitoring and relapse prevention tool with didactic reviews and practices of recorded skills and monthly feedback based on daily calls.
16148274|NCT01794988|Behavioral|NO TIVR|Control - no intervention
16148275|NCT01794975|Drug|Ketamine|
16148276|NCT01794975|Drug|Atomoxetine|
16148277|NCT01794975|Other|Cold pressor test|
16148278|NCT01794975|Drug|Placebo|
16148279|NCT01794962|Other|Cognitive functional therapy|The intervention is directed at the maladaptive cognitive, physical and lifestyle behaviours associated with the disorder.
16148280|NCT01794962|Other|manual therapy and exercises|Patients in this group will be treated with joint mobilization or manipulation techniques applied to the spine or pelvis primarily and is designed to be consistent with best current manual therapy practice.
16148281|NCT01794949|Device|Resolute Integrity stent|Drug eluting stents used to treat coronary artery blockages
16148282|NCT01794936|Device|VTI Probe|The VTI 20 MHz microvascular Laparoscopic Doppler System is a blood flow detector that compensates for the loss of tactile sensation during laparoscopic procedures by eliminating misunderstandings related to surrounding vascular anatomy. The system's sterile doppler probes fit through standard 5mm ports, making it easy to use with no special training required.
16148283|NCT01794923|Drug|IBU BID|10-cm strip of IBU 5% topical gel applied to the affected area BID (twice daily) x 3 days
16148284|NCT01794923|Drug|Placebo BID|10-cm strip of placebo topical gel applied to the affected area BID (twice daily) x 3 days
16148285|NCT01794923|Drug|IBU TID|10-cm strip of IBU 5% topical gel applied to the affected area TID (three times daily) x 3 days
16148286|NCT01794923|Drug|Placebo TID|10-cm strip of placebo topical gel applied to the affected area TID (three times daily) x 3 days
16148287|NCT01794910|Other|Pelvic floor muscle therapy|The women performed perineal contraction exercises in the dorsal decubitus, sitting, and standing positions and was applied twice per week for a total of 15 sessions
16148288|NCT01794897|Drug|Experimental: Valacyclovir treatment|Patients will have a placebo run-in for two weeks after which they will be evaluated for the variables of interest and then randomized to either VAV or placebo group in a 1:1 proportion. The VAV group will receive 1.5 g Valacyclovir by mouth, twice daily for 16 weeks, after which they will be followed up without VAV for 4 weeks to monitor delayed adverse effects.
16148289|NCT01794897|Drug|Placebo comparator|Patients will have a placebo run-in for two weeks after which they will be evaluated for the variables of interest and then randomized to either VAV or placebo group in a 1:1 proportion. Subjects in the placebo arm will receive placebo for 16 weeks, after which they will be followed up without placebo for 4 weeks to monitor delayed adverse effects.
16148290|NCT01794884|Drug|Glutamine|20% N(2)-L-alanyl-L-glutamine 0.4g/kg(2ml/kg) mixed with compound amino acid (10ml/kg).Intravenous injection twice (24 hours、1 hour before operation). Injection rate = 6ml/kg/h
16148291|NCT01794884|Drug|Ringer's solution|Ringer's solution 12ml/kg. Intravenous injection twice (24 hours、1 hour before operation). Injection rate = 6ml/kg/h.
16148292|NCT01794858|Other|Therapeutic Hypothermia|Will receive medically-necessitated ventilator support under ICU monitoring with core temperatures ≥36°C and severe acute pancreatitis defined as either a Ranson Score ≥7, a CT indicating ≥50% pancreatic necrosis, or a significant deterioration in clinical status including dysfunction of two or more organ systems. All patients will receive current standard management for severe acute pancreatitis and a standardized protocol for application of therapeutic hypothermia and rewarming. Our primary endpoints are organ-specific cardiovascular, respiratory, hematological, renal, and metabolic dysfunction as measured at 28 days. Logistic Organ Dysfunction Scores will be compared before and after therapeutic hypothermia, establishing day 4 versus day 1 changes in LOD.
16148293|NCT01794845|Drug|Erbitux|Erbitux: 400 mg/m2 as a loading dose one week prior to radiation and taxotere, and then at 250 mg/m2 given weekly on Day 1 of treatment week following Taxotere.
16148294|NCT01794845|Drug|Taxotere|Taxotere : 20 mg/m2 IV once a week on Day 1 during treatment weeks 2 to 7.
16148295|NCT01794845|Radiation|Low Dose Fractionated Radiation Therapy|Low-dose fractionated Radiation (LDFRT): 0.5 Gy per fraction twice-a-day (BID) at least 6 to 8 hours apart on Days 2 and 3 of treatment weeks 2 to 7 for a total dose of 12 Gy.
16148296|NCT01794819|Device|C-reactive protein test|Results provides within 5 minutes. This test is based on solid-phase sandwich immunometric analysis. The measurement range in whole blood samples is 8-200 mg/L.
16148297|NCT01794806|Procedure|Tooth extraction and grafting with allograft|Alveolar ridge preservation using a bone grafting material (allograft) and a synthetic dPTFE (dense Polytetrafluoroethylene) barrier membrane
16148298|NCT01794806|Procedure|Tooth extraction|Minimally traumatic single-rooted tooth extraction
16148299|NCT01794793|Drug|Pasireotide|Administered subcutaneously in strengths 0.3mg, 0.6mg and 0.9mg. Doses to be taken BID or TID, dependent on parent study guidelines.
16148376|NCT01794247|Drug|Fentanyl|
16148300|NCT01794793|Drug|Cabergoline|Cabergoline tablet 0.5mg or 1.0mg taken by mouth once daily may be combined with subcutaneous formulation of pasireotide for Cushing's Disease or Acromegaly. Dose is dependent on parent study guidelines.
16148301|NCT01794793|Drug|Pasireotide|Long Acting Release is administered by monthly injection. The strengths are 10mg, 20mg, 40mg and 60mg. All doses to be taken q28days. Strength is dependent on parent study guidelines.
16148302|NCT01794780|Drug|LABA based treatment: indacaterol|LABA based treatment: indacaterol
16148303|NCT01794780|Drug|LAMA based treatment: tiotropium|LAMA based treatment: tiotropium
16148304|NCT01794780|Drug|LABA/ICS based treatment: salmeterol/fluticasone|LABA/ICS based treatment: salmeterol/fluticasone
16148305|NCT01794780|Drug|LABA/ICS based treatment: budesonide/formoterol|LABA/ICS based treatment: budesonide/formoterol
16148306|NCT01794780|Drug|theophylline based treatment|theophylline based treatment
16148307|NCT01794780|Drug|Other treatment|"non-long-acting bronchodilators for COPD treatment, such treatments were classified as other treatments"
16148308|NCT01794767|Drug|0,9% NaCl flush|Normal Saline solution
16148309|NCT01794767|Drug|Heparin 50U/ml|Heparin solution
16148310|NCT01794754|Other|Care as usual|
16148311|NCT01794754|Other|Occupational therapy|Occupational therapy in the waiting period before surgery. Occupational therapy comprises orthoses for the CMC-joint, hand exercises, and use of alternative working methods and assistive devices. The participants are encouraged to perform hand exercises three times a week for the first 12 weeks, and to use orthosis as much as possible, both during daytime (day orthosis) and night time (night orthosis).
16148312|NCT01794741|Drug|Dymista Nasal Spray|
16148313|NCT01794741|Drug|Fluticasone propionate nasal spray|
16148314|NCT01794715|Procedure|Ultrasound examination by nurses|Ultrasound examination performed by nurses. Focused examination of the pleural space and inferior vena cava.
16148315|NCT01794702|Drug|Decitabine|Phase I and II - 20 mg/m2 by vein daily for 5 days (days 1-5)
16148316|NCT01794702|Drug|Idarubicin|Phase I and II - 10 mg/m2 by vein daily for 3 days (days 6-8)
16148317|NCT01794702|Drug|Cytarabine|Phase I and II - 1 g/m2 by vein daily for 5 days (days 6-10)
16148318|NCT01794702|Drug|Clofarabine|"Phase I Starting Dose - 15 mg/m2 by vein daily for 4 days (days 6-9)
~Phase II Starting Dose - Maximum tolerated dose from Phase I (number of days selected based on Phase I portion)."
16148319|NCT01794689|Drug|Morphine|0.08mg/kg will be administered to participants randomly assigned to receive the drug via IV bolus during each quantitative sensory testing session (after one night of uninterrupted sleep and after 2 nights of forced awakenings).
16148320|NCT01794689|Drug|Saline Placebo|Saline Placebo will administered to participants randomly assigned to receive the placebo via IV bolus during each quantitative sensory testing session (after one night of uninterrupted sleep and after 2 nights of forced awakenings).
16148321|NCT01794689|Behavioral|Forced Awakenings|Participants will be awakened each hour during an 8 hour sleep opportunity period. One of the awakenings is for 60 minutes and randomly determined. The other 7 awakenings are for 20 minutes each, and are randomly scheduled to occur in either the first second or third tertile of each hour. The maximum total sleep time a participant will receive is 280 minutes.
16148322|NCT01794689|Behavioral|Uninterrupted Sleep|Participants will receive an 8 hour period of undisturbed sleep
16148323|NCT01794676|Genetic|Blood draw|Blood draw
16148324|NCT01794663|Drug|OPN-305|Intravenous infusion for 1 hour at start of transplant procedure
16148325|NCT01794663|Drug|Placebo|Intravenous infusion for 1 hour at start of transplant procedure
16148326|NCT01794650|Dietary Supplement|Meal composition|
16148327|NCT01794624|Behavioral|Cognitive Therapy for Catastrophizing|Cognitive Therapy for Catastrophizing will involve a standardized, 6-session cognitive intervention, focusing on cognitive restructuring techniques for managing pain and reducing catastrophic thinking and includes some general coping skills training. Cognitive restructuring includes identifying patterns of dysfunctional thinking which can give rise to emotional distress, physiological arousal, or maladaptive behaviors. Patients are taught to identify and replace distorted thinking with balanced, realistic thinking. Patients learn to identify these thoughts as they occur in daily life and challenge their own negative thoughts.
16148328|NCT01794624|Behavioral|Behavioral Therapy for Sleep Continuity Disturbance|Behavioral Therapy for Sleep Continuity Disturbance (BT-SCD) will involve 6-sessions of standardized interventions on sleep restriction therapy (SRT), stimulus control therapy (SCT), and sleep hygiene education. Sleep Restriction curtails the amount of time in bed so that it matches the average baseline amount of total sleep time. Stimulus Control Therapy re-establishes the bed and bedroom as cues for sleep by insuring the patient does not spend significant time in bed awake and/or engaging in sleep-incompatible behaviors. Sleep Hygiene Education uses motivational interviewing to teach subjects about environmental and behavioral factors which may influence sleep. SRT and SCT alone or combined have demonstrated overwhelming efficacy and effectiveness.
16148329|NCT01794611|Device|laryngoscopy|
16148330|NCT01794598|Behavioral|Receiving educational material of depression care|The educational material provides patients about depression management
16148331|NCT01794585|Behavioral|Virtual Reality Based Exercise|A structured, individually tailored, protocol driven, reproducible therapeutic intervention. The study intervention will consist of individually prescribed selections from three off-the-shelf VR games that target the type and severity of balance deficits elicited during the completion of a baseline assessment. Participants randomized to receive this intervention will be assigned a home balance program that utilizes an Xbox Kinect system to provide balance activities.
16148332|NCT01794585|Behavioral|Standard Exercise|An individualized home balance exercise program that also targets identified balance system-specific deficits, however, utilizes no VR components.
16148333|NCT01794572|Drug|Melphalan|Melphalan: 140 mg/m²is infused intravenously in 30 minutes on day -2 after IV anti-emetics (5-HT3 antagonists).
16148334|NCT01794572|Biological|Autologous Hematopoietic Stem cell|"Autologous Peripheral Stem Cell Rescue : 2.5 10^6 CD-34/Kg are re-infused in the central line on day 0 after adequate premedication."
16148335|NCT01794559|Device|PEER Interactive Report|The PEER Interactive Report provides information comparing the subject's Quantitative Electroencephalography (QEEG) to a database of outcomes from patients with similar QEEG results, and how they responded to on-label treatments. This report provides a probability of how this subject will respond to treatment based upon a comparison of similar subjects in the database.
16148336|NCT01794546|Behavioral|Telehealth|Telehealth visits will alternate between a dietitian and behavioral medicine provider for either 30 minutes or 1 hour. Over a 6-month period, 12 telehealth sessions will be scheduled for each participant. The dietitian will provide dietary and physical activity recommendations, and the behavioral medicine provider will counsel on strategies for achieving specific goals. Applying a Chronic Care Model, self-management support will be augmented by linkages to community resources.
16148337|NCT01794533|Drug|Lidocaine with Epinephrine+ Normal saline|local infiltration of 1.8 mL of 2% lidocaine containing 1:200,000 epinephrine along with 0.8 mL of 0.9% sterile normal saline solution
16148338|NCT01794533|Drug|Lidocaine with Epinephrine + fentanyl|local infiltration of 1.8 mL of 2% lidocaine, containing 1:200,000 epinephrine along with 0.8 mL of fentanyl(40 µg)
16148339|NCT01794520|Drug|Dexamethasone|Dexamethasone at defined dose and schedule for Venetoclax-Dexamethasone combination cohort.
16148340|NCT01794520|Drug|ABT-199|ABT-199 dosed at cohort-defined dosing schedules.
16148341|NCT01794507|Drug|ABT-199|ABT-199 at cohort-defined dosing schedules and dose levels. ABT-199 at defined dose and schedule for Safety Expansion cohort
16148342|NCT01794507|Drug|bortezomib|Bortezomib at cohort-defined dosing schedules and dose levels. Bortezomib at defined dose and schedule for Safety Expansion cohort
16148343|NCT01794507|Drug|dexamethasone|Dexamethasone at cohort-defined dosing schedules and dose levels. Dexamethasone at defined dose and schedule for Safety Expansion cohort.
16148344|NCT01794494|Procedure|Bypass surgery|Patients are treated with femoro-popliteal bypass
16148345|NCT01794494|Procedure|Endovascular recanalization|Patients are treated with PTA or subintimal angioplasty
16148346|NCT01794481|Procedure|Resistance Exercise Training (RET)|"If you are randomized to the resistance exercise training (RET) program, you will undergo up to three 1-hour training sessions per week for 7 weeks during radiation therapy.
~There will be up to 3 sessions per week lasting up to one hour, and will generally include a 10- minute warm-up, rest periods and 10 minute cool-down. The goal is to perform the exercises as tolerated in week 1 and increase intensity as the weeks progress. Weights will be added each week depending on your tolerance to them. Rest periods will be incorporated into the exercises as needed. The intensity and weights used will be customized to the individual. During the home program portion, you will be asked to keep a weekly log of your exercises and the trainer will call you weekly to go over the log and provide support. At week 11 the trainer will meet with you to go over your individualized program and review your technique."
16148347|NCT01794468|Other|Dermal blood flow measurements|Dermal blood flow was measured with the Dermal Blood Flow (DBF) monitor (I.S. MedTech, Israel), which consists of a skin probe and a measuring and control feedback unit.
16148348|NCT01794455|Drug|Sertraline|50mg - 200mg daily
16148349|NCT01794455|Drug|Candesartan|4mg - 32mg daily
16148350|NCT01794429|Drug|Exenatide|Subcutaneum injection of exenatide once-weekly for 3 months
16148351|NCT01794429|Drug|Placebo|Subcutaneum injection of placebo once-weekly for 3 months
16148352|NCT01794416|Procedure|Thoracoscopic epicardial ablation|
16148353|NCT01794416|Procedure|Endocardial catheter ablation|
16148354|NCT01794416|Device|Implantable loop recorder|
16148355|NCT01794403|Radiation|Extended Hypofractionation Radiotherapy|A total dose of 70.2 Gy will be delivered in 26 fractions, 2.7 Gy to the Planning Target Volume (PTV) by Intensity Modulated Radiotherapy (IMRT) with stationary gantry or rotating gantry technique.
16148356|NCT01794403|Radiation|Accelerated Hypofractionation Radiotherapy|A total dose of 36.25 Gy will be delivered in 5 fractions, 7.25 Gy each to the Planning Target Volume (PTV), by Stereotactic Body Radiotherapy (SBRT) techniques.
16148357|NCT01794377|Behavioral|30 minutes of high intensity training|"This group will carry out a 5-min warm-up period on bicycle ergometer at an intensity corresponding to 50% of Vo2max before performed eight times the intermittent training exercise as follows:
~30 sec at 120% of Vo2max,
~1 min at 50% of Vo2max,
~15 sec at 30-40 revolutions per minute of strength training at 100% of the maximal anaerobic power, which will be first determined by means of a force-velocity test on a Monark ergometer,
~1 min at 50% of Vo2max.
~The training session will be terminated by a 3-min cool-down period at 40% of Vo2max.
~Training three times per week for 5 months under supervision of an exercise physiologist.
~Initial nutritional education session at the beginning of the study Questionnaires on training experience during the 5 months training period (Exercise difficulties, pain...).
~Dietary Supplement: supplementation in fruits and vegetables (5 per day) during all the study."
16148358|NCT01794377|Behavioral|40 of an endurance training|"The moderate-intensity continuous exercise group will carry out a 40-min session of continuous cycling at a moderate intensity (50 % of Vo2max).
~Training three times per week for 5 months under supervision of an exercise physiologist.
~Initial nutritional education session at the beginning of the study Questionnaires on training experience during the 5 months training period (Exercise difficulties, pain...).
~Dietary Supplement: supplementation in fruits and vegetables (5 per day) during all the study."
16148359|NCT01794364|Drug|PF-06291874|PF-06291874 will be administered as an extemporaneously prepared suspension for all doses within the initially planned range of 75 mg to 500 mg.
16148360|NCT01794364|Other|placebo|Correspondingly, placebo doses will be administered as suspension.
16148361|NCT01794351|Dietary Supplement|Trans-resveratrol|In this crossoevr study, all participants also consumed 500mg trans-resveratrol (in 2 opaque vegetarian capsules), at baseline, on counterballanced days.
16148362|NCT01794351|Other|Placebo|In this crossoevr study, all participants also consumed placebo (2 opaque vegetarian capsules), at baseline, on counterballanced days.
16148363|NCT01794338|Device|Strattice Arm|Biologic mesh to be placed during hernia repair surgery
16148364|NCT01794338|Device|Bio-A Arm|Bioabsorbable mesh to be placed during hernia repair surgery
16148365|NCT01794325|Other|Trans-radial|Coronary angiography performed through trans-radial access
16148366|NCT01794325|Other|Trans-femoral|Coronary angiography performed through trans-femoral access
16148367|NCT01794312|Device|T4020|
16148368|NCT01794312|Device|Vehicle|
16148369|NCT01794299|Biological|ATIR|Donor T-lymphocytes depleted ex vivo of host alloreactive T-cells using photodynamic treatment. Single intravenous infusion with 2x10E6 viable T-cells/kg.
16148370|NCT01794286|Other|Provider bulletins|
16148371|NCT01794286|Other|Trigger alerts|
16148372|NCT01794273|Drug|ephedrine and phenylephrine|
16148377|NCT01794247|Drug|Lidocaine|
16148378|NCT01794221|Procedure|stitches and skin adhesive|In addition to stitches, 2-octyl cyanoacrylate skin adhesive will be applied to the circumcision wound.
16148379|NCT01794221|Procedure|stitches only|standard of care
16148380|NCT01794208|Drug|Follitropin Epsilon|
16148381|NCT01794208|Drug|Follitropin Alfa|
16148382|NCT01794195|Behavioral|Diffusion tensor imaging and fibres tracking|
16148383|NCT01794182|Drug|Glyburide for Injection|Administered as specified in the treatment arm.
16148384|NCT01794182|Drug|Placebo|Administered as specified in the treatment arm.
16148385|NCT01794169|Drug|Azacitidine|
16148386|NCT01794169|Drug|DA|
16148390|NCT01794143|Drug|Sulfonylurea (glimepiride)|Used in accordance with labeling and/or usual practice.
16148391|NCT01794143|Drug|DPP-4 inhibitor (sitagliptin)|Used in accordance with labeling and/or usual practice
16148392|NCT01794143|Drug|GLP-1 receptor agonist (liraglutide)|Used in accordance with labeling and/or usual practice.
16148393|NCT01794143|Drug|Insulin (glargine)|Used in accordance with labeling and/or usual practice.
16148394|NCT01794117|Drug|Anakinra|An initial dose of anakinra 100 mg/day will be administered daily via self-administered subcutaneous injection. If active disease persists at this dose, anakinra dose may be escalated up to 200 mg/day injected subcutaneously daily at week 4 and 300mg/day at week 8.
16148395|NCT01794104|Drug|LMP400|Top1 inhibitors such as LMP400 are potent anticancer agents because stabilizing cleavage complex formation induces replication-and transcription-mediated DNA damage and delays DNA repair, leading to apoptosis. Preclinical and clinical data indicate that baseline tumor levels of Top1 correlate strongly with ability to respond to Top1 inhibitor therapy.
16148396|NCT01794091|Drug|Eplerenone|Eplerenone 25 mg daily for 6 months
16148397|NCT01794091|Drug|Placebo|
16148398|NCT01794078|Drug|Aminophylline 400 mg|Xanthine derivative
16148399|NCT01794078|Drug|Ambrisentan 5 mg|Endothelin receptor antagonist
16148400|NCT01794078|Other|Placebo|
16148401|NCT01794052|Other|Evidence based, DSS enabled, health care delivery model|"The study focus on preliminary work before a definitive randomised controlled trial. In this phase, we are developing an intervention for the evidence based management of hypertension and diabetes at primary care setting in India.
~The components of the interventions that we are developing are:
~A structured training of the health care staff for identifying people at risk of developing diabetes or hypertension
~Treating patients as per a standard clinical guidelines
~Giving health education to patients on lifestyle changes for better self-care
~Optimizing the care pathways at the health facilities to enable better delivery of the intervention and
~Development and implementation of a smartphone based decision support system (DSS) with inbuilt diagnostic and treatment algorithm"
16148402|NCT01794039|Drug|Dexamethasone|Given PO
16148403|NCT01794039|Drug|Lenalidomide|Given PO
16148404|NCT01794039|Drug|Pomalidomide|Given PO
16148405|NCT01794026|Procedure|diffusion weighted magnetic resonance imaging|for diagnostic purposes, diffusion weighted magnetic resonance imaging in all patients
16148406|NCT01794013|Behavioral|Parent training|All parents in the intervention group had to learn about DIR/ Floortime™ model approach through one on one coaching (1 hour/ session for three sessions) and through 2 hours DVD lecture.
16148407|NCT01794013|Behavioral|Routine care|routine care
16148408|NCT01794000|Drug|Prasugrel|Administered orally
16148409|NCT01794000|Drug|Placebo|Administered orally
16148410|NCT01793987|Device|Coblation polypectomy|
16148411|NCT01793961|Other|electroretinogram|
16148412|NCT01793961|Other|contrast sensitivity tests|
16148413|NCT01793948|Drug|metformin hydrochloride|Given PO
16148414|NCT01793948|Other|placebo|Given PO
16148415|NCT01793948|Other|laboratory biomarker analysis|Correlative studies
16148416|NCT01793935|Drug|Sensoril®|Sensoril® is a proprietary extract of Withania Somnifera. Each Sensoril® capsules will contain 250 mg of standardized extract of Withania Somnifera
16148417|NCT01793935|Drug|Placebo|Each Placebo capsule comprises inert ingredients; microcrystalline cellulose NF 102, croscarmellose Sodium NF, silicon Dioxide, Fumed NF (Cab-0-sil), magnesium sterate, NF matched in appearance and fill weight to Sensoril® capsules. Moreover, based on past experience, we will expose the placebo capsules to covered sachets containing Sensoril, so that the smell permeates the placebo capsules which then smell like the Sensoril capsules.
16148418|NCT01793922|Procedure|PD|pneumodilation
16148419|NCT01793922|Procedure|POEM|peroral endoscopic myotomy
16148420|NCT01793909|Other|Single Leg Exercise Training|Following the completion of baseline testing, all 3 subject groups will undergo supervised single leg, exercise training of the index (dominant) calf muscle 5 days per week for two weeks - alternating weight-bearing single leg calf raises and single leg calf extensions by endurance resistance training (weight machine apparatus).
16148421|NCT01793896|Behavioral|Control period|Analysis at recruitment and after a month without any intervention
16148422|NCT01793896|Behavioral|Diet Group|selected subjects will adopt a Mediterranean low-AGE diet. We will not include red wine in the Mediterranean diet (7 Kilocalories (KCal)/g), in order to attain more weight loss. Each subject will be instructed to reduce 500 Kcal of their estimated total daily energy requirements, so theoretically they will be able to reduce 5 - 10 % of their body weight in 3 months.
16148423|NCT01793896|Behavioral|Exercise group|The intervention will consist of 3 weekly 1 hour sessions (5 minutes of preconditioning, followed by 20 minutes cycling, brisk walking or jogging at 65-70 % maximal aerobic capacity, then 25 minutes resistance weight-lifting exercises and finally 10 minutes of stretching). Exercise intensity will be increased weekly according to the Borg Scale intensity. The exercise intervention will be supervised by physical education teachers, registering attendance at every session.
16148424|NCT01793896|Behavioral|Diet + Exercise|these patients will be incorporated to receive both Mediterranean diet plus exercise interventions
16148425|NCT01793883|Drug|40 mg Laninamivir Octanoate|
16148426|NCT01793883|Drug|80 mg Laninamivir Octanoate|
16148427|NCT01793883|Drug|Placebo|
16148428|NCT01793870|Drug|Tab carvedilol 25 mg|Carvedilol 25 mg immediate release tablet
16148429|NCT01793870|Drug|Tab carvedilol 6.25 mg|Carvedilol 6.25 mg immediate release tablet
16148430|NCT01793870|Drug|Powder carvedilol up to 2.5 mg|Carvedilol up to 2.5 mg isotopically enriched drug substance powder
16148431|NCT01793857|Other|Data collection|Paper questionnaire
16148432|NCT01793831|Procedure|FMT|Standard FMT
16148433|NCT01793818|Biological|Tat Oyi|Three injections in the arm
16148434|NCT01793792|Device|LVIS™ and LVIS™ Jr|The LVIS Device is intended for use with embolization coils for the treatment of wide neck, intracranial aneurysms.
16148435|NCT01793779|Procedure|cold water immersion|
16148436|NCT01793779|Dietary Supplement|beta-hydroxy-beta-methylbutyrate free acid (HMB-FA)|
16148437|NCT01793779|Dietary Supplement|Placebo|
16148438|NCT01793766|Device|Brain modulation|Brain modulation using Eldith/Neuroconn transcranial Direct Current Stimulation device
16148439|NCT01793766|Device|Sham modulation|
16148440|NCT01793753|Drug|Propofol|
16148441|NCT01793740|Behavioral|Cogmed|Computer based program that aims to improve children's memory, attention, and processing speed.
16148442|NCT01793727|Device|Glidescope videolaryngoscope|
16148443|NCT01793688|Drug|Sulbactam Sodium/Ampicillin Sodium|"Intravenous use; The usual adult dosage is 6 g of sulbactam sodium and ampicillin sodium (potency) per day given in two divided doses via intravenous injection or drip infusion. In the case of severe infection, the dosage may be increased if appropriate. Maximum dosage should not exceed 3 g (potency) 4 times daily (daily dose of 12 g (potency)).
~Kit for intravenous use; The usual adult dosage is 6 g of sulbactam sodium and ampicillin sodium (potency) per day given in two divided doses via intravenous injection after dissolved in an accompanying reconstitution diluent. In the case of severe infection, the dosage may be increased if appropriate. Maximum dosage should not exceed 3 g (potency) 4 times daily (daily dose of 12 g (potency))."
16148444|NCT01793675|Procedure|transplant with haploidentical donor|patients with advanced MDS without identical sibling donor receive haploidentical transplant
16148445|NCT01793662|Procedure|Laparoscopic aortobifemoral bypass|Totally laparoscopic aortobifemoral bypass shall be performed and the patients in this intervention arm shall be compared with the control arm randomized for open aortobifemoral bypass operation.
16148446|NCT01793649|Drug|GS-5737|A single dose of GS-5737 in 2.8% saline
16148447|NCT01793636|Drug|AZD2014|AZD2014 vs Everolimus
16148448|NCT01793636|Drug|Everolimus|comparing PFS in patients treated with AZD2014 vs Everolimus
16148449|NCT01793623|Other|atrial tissue|retrieval of discarded atrial tissue
16148450|NCT01793610|Drug|Comparative-dose (40mg) MDMA|An initial comparator-dose of 40 mg MDMA orally given at the start of two separate psychotherapy sessions scheduled 3 to 5 weeks apart, with the initial dose possibly followed 1.5 to 2.5 hours later by a supplemental dose half the size of the initial dose (20 mg MDMA).
16148451|NCT01793610|Drug|Active Dose 2 (100 mg) MDMA|An initial dose of full-dose 100 mg MDMA orally given at the start of two separate psychotherapy sessions scheduled 3 to 5 weeks apart, with the initial dose possibly followed 1.5 to 2.5 hours later by a supplemental dose half the size of the initial dose (50 mg MDMA).
16148452|NCT01793610|Drug|Active Dose 1 (125 mg) MDMA|An initial dose of full-dose 125 mg MDMA orally given at the start of two separate psychotherapy sessions scheduled 3 to 5 weeks apart, with the initial dose possibly followed 1.5 to 2.5 hours later by a supplemental dose half the size of the initial dose (62.5 mg MDMA).
16148453|NCT01793610|Behavioral|Psychotherapy|Psychotherapy conducted throughout experimental sessions.
16148454|NCT01793584|Procedure|Laparoscopic hysterectomy|LAVH, TLH
16148455|NCT01793584|Procedure|Abdominal hysterectomy|TAH
16148456|NCT01793571|Procedure|TAP block|2 groups, group A a TAP block with 20 ml of Levobupivacaine 0,5% and subcutaneous wound infiltration with 20 ml sodium chloride (to blind patient and physician) and group B, TAP block with 20 ml sodium chloride and subcutaneous wound infiltration with 20 ml Levobupivacaine 0,5% (to blind patient and physician)
16148457|NCT01793558|Procedure|Forced-air warming|In the intervention group a forced-air cover (Level 1 Snuggle Warm Upper Body Blanket, Smiths Medicals) will be positioned over the upper body of the patients laying on the operating table just beginning after the spinal block.
16148458|NCT01793519|Drug|Etanercept|Subcutaneous
16148459|NCT01793519|Drug|Infliximab|Infusion
16148460|NCT01793519|Drug|Adalimumab|Subcutaneous
16148461|NCT01793519|Drug|Placebo|Matching Placebo
16148462|NCT01793493|Other|Cognitive stimulation|"Participants are pooled in small groups (6-8 individuals). Each group participates to ten twice weekly meetings. Each CS session is run by one trained operator. One observer participates to the sessions to guarantee homogeneity between different operators. Exercises are structured with an increasing cognitive complexity and are tailored to the characteristics of the group.
~Meetings (each lasting about 2 hours) have a common structure:
~body awakening (10 minutes)
~cognitive stimulation (1 hour and a half) scheduled as follow:
~temporospatial orientation
~attentional abilities
~one of the following cognitive areas: language, executive functions, verbal and visual memory (encoding, consolidation, retrieval)"
16148463|NCT01793493|Other|Sanitary education|Participants attend two weekly meetings (for a total of 3 hours) focused on lifestyle education and brain functioning.
16148464|NCT01793480|Drug|Methadone|
16148465|NCT01793454|Other|Fraction of inspired oxygen 40%|
16148466|NCT01793454|Other|Fraction of inspired oxygen 80%|
16148467|NCT01793441|Drug|Placebo|Placebo will be administered in different stages of the study for 12 weeks.
16148468|NCT01793441|Drug|RG7314|RG7314 will be administered orally at a dose of 1.5 mg/day in Stage I, 4 mg/day in Stage II, 10 mg/day in Stage III and 1.5 mg/day or 10 mg/day in Stage IV for 12 weeks.
16148469|NCT01793428|Other|Capillary lactate level|Use of capillary sample to determine lactate level upon arrival at vital emergency unit and at 2 hours
16148470|NCT01793415|Drug|IodoCarb (r)|Powder, 3 grams daily for 28+-2 days
16148471|NCT01793415|Other|Placebo|Non-iodinated activated charcoal 3 g daily for 28+-2 days
16148472|NCT01793389|Procedure|Subepithelial connective tissue graft|
16148473|NCT01793389|Procedure|Platelet Rich Fibrin|
16148474|NCT01793363|Procedure|Tracheotomy|
16148475|NCT01793350|Drug|BC-DN-01 topically applied cream|Phase 1 - week 1 - total daily dose 160mg benfotiamine as 8g BC-DN-01 Phase 1 - week 2 - total daily dose 320mg benfotiamine as 16g BC-DN-01 Phase 2 - for 12 weeks - total daily dose 320mg benfotiamine as 16g BC-DN-01
16148476|NCT01793337|Other|Exposure to cold environmental temperature (-20°C)|
16148477|NCT01793311|Other|decaffeinated coffee|contains caffeine 0.5-2 mg
16148478|NCT01793311|Other|regular dose coffee|contains 91.8 mg of caffeine
16148479|NCT01793311|Other|high dose coffee|contains 144 mg of caffeine
16148480|NCT01793298|Drug|ASM-024|Ascending doses of ASM-024
16148481|NCT01793285|Drug|ETANERCEPT|"During the LoadET study (0881A3-102090), subjects were treated with etanercept 100 mg versus 50 mg weekly. After completing this study, the subjects were allowed to continue the treatment with etanercept 50 mg weekly, etanercept 100 mg weekly, another drug, or abandoned medication at the discretion of their physician.
~This is a non-interventional study in which historic data will be collected retrospectively from the patient's clinical history. During the historical period covered in the Study, patients would have received the treatment and the medical care that their treating physicians considered appropriate under the conditions of standard clinical practice."
16148482|NCT01793272|Other|effect of pentoxifylline on ICSI outcome|semen processing with pentoxifylline prior to ICSI
16148483|NCT01793259|Drug|methotrexate prefilled pen|
16148484|NCT01793259|Drug|methotrexate prefilled syringe|
16148485|NCT01793246|Device|probe based laser endomicroscopy (pCLE)|pCLE will be added to standard bronchoscopy for the purpose of characterizing lung cancer or for characterizing of acute rejection in transplanted lungs.
16148486|NCT01793233|Other|Laboratory Biomarker Analysis|Correlative studies
16148487|NCT01793233|Other|Questionnaire Administration|Ancillary studies
16148488|NCT01793220|Other|SMS reminder|A text message reminder service will be sent 7 and 1 days(s) prior to the patients appointment at their Psychosis Community Service.
16148489|NCT01793194|Other|Compression Stockings|20-30mmg Hg maternity pantyhose compression stockings
16148490|NCT01793155|Other|Inspiratory muscle training|Inspiratory muscle training, as a supplement to placebo comparator, starts the day before surgery and continues for two weeks after surgery. No sessions are performed on the surgery day. Each session consists of 2 sets of 30 inspirations with a pause between each set of 2 minutes. The target intensity before surgery is 30% of the measured MIP and starts at 15% after surgery. The intensity is incrementally increased by 2 cm H20 the first days after surgery. Patients grade their perceived exertion and register eventual adverse effects in a training diary.
16148491|NCT01793155|Other|Placebo comparator: standard physiotherapy|Standard physiotherapy - preoperative instruction and postoperative breathing exercises using positive expiratory pressure device (PEP) 3x10 breathings hourly during daytime, cough/huff for mucus clearance purpose, advice on early and active mobilization
16148492|NCT01793142|Drug|Viviant|Viviant (Bazedoxifene) 20mg once daily
16148493|NCT01793129|Device|Hypothermia|Induced Whole-body hypothermia (with a target esophageal temperature of 33.5°C) for 72 hours
16148494|NCT01793129|Procedure|Normothermic Control|Normothermic Control group (with esophageal temperature at or near 37.0°C) for 96 hours
16148495|NCT01793090|Drug|Epi-743|EPI- 743 in capsule or formulation comprised of USP/NF Sesame Oil at a potency of 100 mg EPI-743/ 1 mL total volume. Mode of Administration: Oral with meal or G-Tube infusion with food.
16148496|NCT01793090|Other|Placebo supplementation|Placebo will be administered in the same formulation as the active comparator
16148497|NCT01793077|Drug|Depo-Eligard®|Subcutaneous
16148498|NCT01793064|Behavioral|Adaptive Intervention (AI)|Adaptive Intervention Group (AI) receives adaptive step goals and feedback/incentives based on personal physical activity performance.
16148499|NCT01793064|Behavioral|Static Intervention (SI)|"Static Intervention group (SI) receives a static usual care goal of 10,000 steps/day and feedback/incentives for uploading their pedometer to the study website."
16148500|NCT01793051|Drug|Minocycline|200 mg by mouth for the first dose, then 100 mg by mouth every 12 hours for three months beginning at initiation of Lenalidomide maintenance therapy for MM.
16148501|NCT01793051|Other|Placebo|200 mg by mouth for the first day of Lenalidomide maintenance therapy for MM, then 100 mg doses every 12 hours for three months (three cycles of maintenance chemotherapy).
16148502|NCT01793051|Behavioral|Questionnaires|Completion of MD Anderson Symptom Inventory (MDASI) questionnaires at baseline, weekly during Lenalidomide therapy, and at end of treatment visit.
16148503|NCT01793038|Drug|Aromatase inhibitor (litrezole) plus uFSH arm|literozole tablets 5 mg /day for days 3-7 plus intramuscular injections of uFSH 37.5 IU/day for days 3-12
16148504|NCT01793038|Drug|clomiphene citrate-uFSH arm|clomiphene citrate 50 mg tablets twice /day for 5 days plus 37.5 IU uFSH IM injections daily for 10 days
16148505|NCT01793025|Biological|ATAC Therapy|Unselected peripheral blood mononuclear cells given 24-48 hours after induction or consolidation chemotherapy
16148506|NCT01792999|Device|Contrast-enhanced KBCT|Contrast-enhanced KBCT includes pre-contrast KBCT scan and post-contrast KBCT scan. After the pre contrast scan is completed, a bolus injection of a low osmolar, nonionic, iodinated 300mg of iodine per mL contrast agent, will be injected at a rate of approximately 2.0 mL/s, for a total injection time of approximately 30-60 seconds. 30-60 seconds after the contrast injection, the post-contrast scan will be acquired.
16148507|NCT01792986|Behavioral|water-only 24-hour fasting once per week for 6 weeks|
16148508|NCT01792947|Procedure|Percutaneous electroneurostimulation of dermatome T6|The patients underwent a percutaneous electroneurostimulation of dermatome T6 during 30 minutes, every week during 12 weeks. This intervention was associated to a diet 1200 Kcal
16148509|NCT01792947|Behavioral|Diet 1200 Kcal|The patients assigned to this group must follow a 1200 Kcal diet during months
16148510|NCT01792934|Drug|XELOX regimen according to standard procedures|
16148511|NCT01792934|Drug|FOLFOX regimen according to standard procedures|
16148512|NCT01792934|Procedure|Surgery|
16148513|NCT01792934|Other|radiofrequency ablation (RFA)|
16148514|NCT01792934|Other|transarterial chemo-embolization using irinotecan drug-eluted beads ((DEBIRI-)TACE)|
16148515|NCT01792934|Radiation|stereotactic body radiation therapy (SBRT)|
16148516|NCT01792934|Drug|Bevacizumab|may be added to both regimens according to standard procedures
16148517|NCT01792934|Procedure|tumor biopsy|at baseline (diagnostic or study) biopsy and after 3 or 4 cycles an optional tumor biopsy
16148518|NCT01792921|Behavioral|COG - FUN|
16148716|NCT01791426|Device|Vismed|Instill 1 drop of the Vismed eye drops in each eye 3 to 5 times per day for 90(± 10) day treatment.
16148519|NCT01792908|Device|Kinesio tape|The KT used was Kinesiology Tape® of 5 cm and it was applied according to Kase protocol (Kase K). The first layer of tape consisted of a single strip placed over the anterior talofibular ligament from insertion to origin, with a 50% tension, except the two-centimetre proximal and distal ends, applied with no tension. The same procedure was repeated for the calcaneofibular ligament and posterior talofibular ligament
16148520|NCT01792895|Procedure|Manipulation|The Cervical Spine Manipulation is a manual therapy technique directed at the hypomobile and painful vertebral level. The subject was supine with the cervical spine in a neutral position. The index finger of the therapist applies contact over the posterolateral aspect of the zygapophyseal joint of the hypomobile vertebra. The therapist performs the technique taking account the most limited movement; lateral or rotational. A maximum of 2 attempts will performed on each subject regardless audible cavitation.
16148521|NCT01792895|Procedure|Mobilization|The mobilization is a passive oscillatory technique, applied over cervical region in the hypomobile cervical level, the patient will be in prone and the therapist standing at the head of the patients with his thumbs in opposition placed at the level of the facet of the hypomobile cervical vertebra. A posteroanterior(PA) oscillatory pressure is applied, through the thumbs, over the process of the hypomobile vertebra. This oscillatory mobilization, is performed at a frequency of 2Hz (with metronome control/steps) for 2 minutes and repeated 3 times. The rest time between each mobilization was 1 minute.
16148522|NCT01792895|Procedure|Mobilization with movement|"This is a manual therapy technique that consist of applied a sustain pressure over cervical hypomobile symptomatic level and request to patient a pain free movement.
~For performs it, the therapist placed his thumbs on the articular process of that level. The patient sitting. Then, the subject had to perform actively the painful motion while the therapist guides the movement of that vertebra and resists it while returning to neutral. The strength applied was parallel to the plane of the joint, and the procedure was performed in 3 sets of 10 repetitions."
16148523|NCT01792856|Other|Recovery-oriented intervention|Life coaching is defined as a collaborative, solution-focused, outcome-oriented and systematic process which aims to facilitate enhancement of life experience and goal attainment of an individual in various life domains. It is based on the theoretical framework of positive psychology and behavioural change model, and targets at building up an individual's potential via fostering hope, motivation, self-efficacy and self-regulation. The principles of life coaching thus closely align with recovery orientation that emphasizes on self-initiation and empowerment via person-centred and strength-based approach.
16148524|NCT01792856|Other|psychoeducation|Subjects will receive group-based supportive therapy provided by case managers of JCEP project. The therapy provides patients with psychoeducation about psychosis, stress management, emotional and social support. Coaching and cognitive-behavioural techniques will not be incorporated. Therapy sessions and duration will be comparable to that of recovery-oriented coaching program.
16148525|NCT01792843|Behavioral|data|"comparisons of clinical characteristics
~comparisons of cognitive profiles
~comparisons of grey matter density patterns
~comparisons of EEG rhythms features"
16148526|NCT01792830|Drug|Metformin|"Metformin is an oral antidiabetic agent used to control high blood glucose levels and is given in divided doses with meals. During treatment initiation and dose titration, the patient's blood glucose levels will be used to determine the therapeutic response to metformin and identify the minimum effective dose for the patient.
~Patients without a history of diabetes and admission HbA1c < 7% requiring SC insulin therapy in the hospital will be discharged on metformin monotherapy.
~Treatment naïve patients with an HbA1c between 7% and 9% prior to admission will be discharged on metformin monotherapy or a combination of metformin and a single dose of subcutaneous insulin."
16148527|NCT01792830|Drug|Glargine insulin|"Glargine is a recombinant human insulin analog that exhibits a constant glucose-lowering profile over 24 hours and permits once-daily dosing. It is administered subcutaneously once a day at the same time every day.
~Patients with an HbA1c between 7% and 9% requiring subcutaneous insulin therapy in the hospital will be discharged on oral metformin and a single dose of glargine insulin at 50% of total daily hospital dose.
~Patients with an HbA1c > 9% will be discharged on oral metformin and a single dose of glargine insulin at 80% of total daily hospital dose."
16148528|NCT01792830|Drug|Glulisine|Glulisine is an injectable, recombinant insulin analog. The total daily dose varies between 0.5 to 1 unit/kg/day depending on the levels of blood glucose. Glulisine will be given within 15 minutes before a meal or within 20 minutes after starting a meal.
16148529|NCT01792817|Device|GammaCore|Treatment with active gammacore vagus nerve stimulator
16148530|NCT01792817|Device|Sham GammaCore device|Treatment with sham stimulator
16148531|NCT01792804|Drug|Trimethoprim-Sulfamethoxazole|study drug 1
16148532|NCT01792804|Drug|Clindamycin|study drug 2
16148533|NCT01792804|Drug|Linezolid|study drug 3
16148534|NCT01792804|Drug|Flucloxacillin|study drug 4
16148535|NCT01792804|Drug|Cloxacillin|study drug 5
16148536|NCT01792804|Drug|Vancomycin|study drug 6
16148537|NCT01792804|Drug|Daptomycin|study drug 7
16148538|NCT01792804|Drug|Cefazolin|study drug 8
16148539|NCT01792791|Procedure|Tissue sample collection at the time of surgery|"Spanning surgery
~A blood sample (32.5 ml)
~joint aspirate (removal of synovial fluid) from both knees
~urine sample
~ORIF surgery
~Joint aspirate (removal of synovial fluid) from both knees
~A blood sample (32.5 ml)
~Urine Sample
~If patients only require one surgery, sample will be collected only once."
16148540|NCT01792778|Device|ViaValve Safety IV Catheter|Insertion of the peripheral intravenous catheters into both upper extremities of subjects
16148541|NCT01792778|Device|Insyte Autoguard BC [Blood Control] Shielded IV Catheter|
16148542|NCT01792765|Other|Ultrasound guidance|Patient will have intraoperative ultrasound .
16148582|NCT01792557|Drug|Crystallized phenol|Crystallized phenol application for pilonidal disease treatment. After sacrococcygeal region of the patient is cleaned from hairs, hairs inside the sinus are removed than crystallized phenol is applied in to the cleaned sinus. Following 2 minutes of phenol exposure, crystallized phenol is removed from the sinus. Crystallized phenol application will be repeated weekly for 4 weeks.
16148583|NCT01792557|Procedure|Limberg Flap|Limberg Flap surgery for pilonidal disease treatment
16148584|NCT01792557|Procedure|Modified Limberg Flap|Limberg flap surgery rhomboid incision is made asymmetrically 2-3 cm lateral to the midline on the side opposite to the donor area.
16148585|NCT01792557|Procedure|Karydakis Flap|Karydakis Flap surgery for pilonidal disease treatment
16148586|NCT01792544|Other|Statement|
16148543|NCT01792752|Behavioral|Enhanced HIV Care Access and Retention Intervention|Through the Enhanced HIV Care Access and Retention Intervention, the five neighborhoods will receive the 4 components of the intervention: 1) HIV Testing Campaign; 2) Treatment Re-engagement Campaign; 3) Patient Navigator Linkage to Care and Substance Abuse Treatment Team; and 4) Mobile Care Clinic. In addition to these intervention components, study participants will receive screening and access to treatment for other physical and mental co-morbidities, general primary health care, and social/psychosocial services addressing unstable housing, food insecurity, interpersonal violence, legal issues. All HIV-positive IDUs identified either through the HIV Testing Campaign or the Treatment Re-engagement Campaign will be enrolled in the HIV Care Cohort. The HIV Care Cohort will be comprised of the HIV-positive injectors who are receiving direct services in the Mobile Care Clinic. The 4 intervention components are detailed below:
16148544|NCT01792752|Behavioral|HIV Testing Campaign|When the intervention is initiated in a neighborhood, HIV rapid testing will begin and continue in a particular neighborhood from the time that the neighborhood's intervention begins until the end of the study period. Anyone testing HIV positive will be seen and counseled by a member of the Patient Navigator Team.
16148545|NCT01792752|Behavioral|Treatment Re-engagement Campaign|Simultaneously with the introduction of the HIV Testing Campaign, a patient navigator team will approach HIV-positive IDUs identified as not having seen their HIV care provider in the last 6 months. In addition, known HIV-positive IDUs within the designated neighborhoods will be approached for service enrollment and meet with a patient navigator.
16148546|NCT01792752|Behavioral|Patient Navigator Linkage to Care and Substance Abuse Treatment Team|The patient navigator team will provide informational support to the HIV-positive injectors, motivate them to attend HIV care visits and engage in substance abuse treatment, encourage their use of and adherence to antiretroviral therapies, and work with them to overcome any barriers to attendance at HIV care visits and substance abuse treatment. All clients of the patient navigator will become part of the HIV Care Cohort; they will have been identified either in the HIV Testing Campaign or the Treatment Re-Engagement Campaign.
16148547|NCT01792752|Behavioral|Mobile Care Clinic|Participants who choose to receive services in the study mobile HIV care clinic will receive an initial appointment and the patient navigator will ensure that the client attends it. At the initial visit, clients will have a medical history taken, be examined and have blood drawn to measure CD4 and viral load. The mobile care clinic doctor will also prescribe medications for the client at the subsequent visit which will be scheduled as soon as lab results are available and interpreted, approximately one week later. The mobile HIV care clinic van will provide health services to the general IDU population within each intervention neighborhood to avoid any stigmatization of the HIV positive clients.
16148548|NCT01792739|Drug|Lactobacillus casei variety rhamnosus granules|"Lactobacillus casei variety rhamnosus granules
~: 3 gram per day (1g-1g-1g, 3 times per day)"
16148549|NCT01792739|Drug|Placebo|"Placebo granules
~: 3 gram per day (1g-1g-1g, 3 times per day)"
16148550|NCT01792726|Radiation|Boost to the tumour bed|Boost to the tumour bed, with whole breast EBRT delivered according to local policy.
16148551|NCT01792713|Drug|Sertaconazole 2% cream|
16148552|NCT01792713|Drug|Placebo|
16148553|NCT01792700|Drug|esomeprazole|
16148554|NCT01792700|Drug|tripotassium dicitrate bismuthate|
16148555|NCT01792700|Drug|metronidazole|
16148556|NCT01792700|Drug|tetracycline|
16148557|NCT01792700|Drug|moxifloxacin|
16148558|NCT01792700|Drug|amoxicillin|
16148559|NCT01792687|Drug|ARN-509|Dose-escalation: 120 milligram (mg), 180 mg, 240 mg, oral, daily
16148560|NCT01792687|Drug|Abiraterone acetate|1,000 mg, oral, daily
16148561|NCT01792687|Drug|Prednisone|5 mg, oral, daily
16148562|NCT01792674|Other|In situ simulation|
16148563|NCT01792674|Other|Off site simulation|
16148564|NCT01792661|Other|Enhanced MyChart|Subjects randomized into the MyChart receive an additional site on their MyChart containing 35 extra educational links specific to CKD, targetting care for stage 3b and stage 4 patients.
16148565|NCT01792661|Other|Patient Navigator|The Patient Navigator aids subjects in education of their CKD, timely scheduling of appointments, plus determining and overcoming barriers to their CKD health care. The Patient Navigator's job is not part of routine medical care.
16148566|NCT01792661|Other|MyChart|Sign-up to MyChart is optional for Cleveland Clinic patients. Subjects enrolled into the study are signed-up for MyChart (if not already signed-up) during the consenting process.
16148567|NCT01792648|Other|Standard reference diet|50% energy as carbohydrate, 15% energy as protein, 35% energy as total fat
16148568|NCT01792648|Other|Almond supplemented diet|50% energy as carbohydrate, 15% energy as protein, 35% energy as total fat, 20% energy from almonds
16148569|NCT01792648|Other|Low carbohydrate reference diet|26% energy from carbohydrate, 29% energy from protein, 45% energy from total fat
16148570|NCT01792635|Drug|PF-05175157|PF-05175157 will be administered at 200 mg twice a day for 43 days.
16148571|NCT01792635|Drug|Placebo|Placebo tablets matched to PF-05175157 will be administered twice a day for 43 days.
16148572|NCT01792622|Other|Interview|Patients will be interviewed to provide descriptive information about their experience as a treated patient with pulmonary arterial hypertension. The interviews will be given one time for approximately 1 hour.
16148573|NCT01792622|Other|Questionnaire|Patients will be asked to provide subjective ratings of their experience on a questionnaire developed from the responses from Phase I. The questionnaire will be given one time for approximately 1 hour.
16148574|NCT01792609|Procedure|Maximum Number of Screws|The tools used for this arm of study are FDA approved with section 510 (k) K122433. These screws are regularly used in all procedures pertaining to Cobb angle correction surgeries outside of the context of this study.
16148575|NCT01792609|Procedure|Minimum Number of Screws|The tools used for this arm of study are FDA approved with section 510 (k) K122433. These screws are regularly used in all procedures pertaining to Cobb angle correction surgeries outside of the context of this study.
16148576|NCT01792596|Other|Pasta with protein|Pasta with Protein
16148577|NCT01792596|Other|Pasta with Fiber|Pasta with Fiber
16148578|NCT01792596|Other|Pasta|Pasta
16148579|NCT01792583|Drug|Modafinil/armodafinil|
16148580|NCT01792570|Drug|RPV + DRV/r|Switch to dual HAART
16148581|NCT01792570|Drug|continue the PI/r-containing HAART.|Continue the on-going triple drug HAART.
16148588|NCT01792531|Behavioral|Parent training group|The More & Less group will focus on how to use positive parenting practices (e.g., reinforcement/encouragement, limit setting, monitoring, problem-solving, positive involvement, and emotion regulation) instead of ineffective practices (e.g., coercive behavior, negative reciprocity, escalation, and negative reinforcement). Using a parent-group approach to intervention administration, each of the twelve More & Less sessions (1.5h/wk) consist of introduction to effective parenting practices followed by a discussion and practice using role play and home practice assignments. The information and procedures will be tailored to focus on changes in the home environment, mostly related to child food habits and physical activity.
16148589|NCT01792531|Behavioral|Standard treatment with focus on lifestyle|The treatment will be provided by local pediatricians in outpatient pediatric departments and will be based on lifestyle modifications, as recommended in the action plan for Stockholm County.
16148590|NCT01792531|Behavioral|Parent training group with booster sessions|Parent training group with additional booster sessions at 8-week intervals for the following year.
16148591|NCT01792518|Drug|Placebo|
16148592|NCT01792518|Drug|Linagliptin 5mg|
16148593|NCT01792505|Biological|Dendritic Cell Vaccine in combination with Imiquimod cream|After a successful complete resection of malignant glioma, patients will receive a total of 3 vaccines, each are 2 weeks apart. Imiquimod cream will be applied prior to and after each vaccination.
16148594|NCT01792479|Drug|BIND-014|
16148595|NCT01792466|Procedure|Transpancreatic sphincterotomy|A sphinctertome will be placed into the pancreatic duct over a guidewire and the sphincter will be cut in the direction of the bile duct
16148596|NCT01792453|Other|Spring water|
16148597|NCT01792414|Device|Sham TES|Neuroconn Eldith device
16148598|NCT01792414|Device|Active TES|Neuroconn Eldith device
16148599|NCT01792401|Drug|Probiotics|
16148600|NCT01792401|Drug|Placebo|
16148601|NCT01792388|Dietary Supplement|Vitamin D|Capsule Form
16148602|NCT01792388|Dietary Supplement|Soya Bean oil|Capsule form
16148603|NCT01792375|Procedure|Concurrent membrane sweeping with Dinoprostone|"Women assigned to Sweep had their cervix swept by inserting the examining finger as high as possible past the internal cervical os, immediately followed by the placement of a 10mg Dinoprostone vaginal insert in the posterior fornix."
16148604|NCT01792375|Drug|10mg Dinoprostone vaginal insert|"For women assigned to No sweep: The only 10mg Dinoprostone vaginal insert were placed in the posterior fornix for cervical ripening"
16148605|NCT01792362|Other|Weight loss diet|Control the patients diet to make them loosing weight
16148606|NCT01792349|Behavioral|STARFISH intervention|STARFISH is a behavioural intervention to encourage the user to become more physically active
16148607|NCT01792323|Drug|Insulin LISPRO|Administration of 15 IU of insulin lispro over a period of 30 seconds
16148608|NCT01792310|Drug|2-hydroxyoleic acid (2-OHOA/2OHOA)|"Patients will receive treatment cycles of 21 days, until any criterion for discontinuation (clinical or radiological progression of disease, clinically unacceptable toxicity, or another general discontinuation criterion) is met.
~Patients are expected to receive between one and 6 cycles of treatment. The treatment period may be extended if clinical benefit is shown.
~In the event of significant GI toxicity, the treatment schedule may be modified from continuous dosing to an intermittent regime In the case of toxicity, the dose of 2-OHOA may be reduced or delayed by up to 14 days at the discretion of the Investigator. A maximum of two dose reductions will be permitted per patient. Treatment holidays of no more than 14 days are also permitted for reasons other than toxicity. Intra-patient dose escalation may be permitted in certain specific circumstances."
16148609|NCT01792297|Dietary Supplement|Bovine colostrum|
16148610|NCT01792297|Dietary Supplement|Whey protein|
16148611|NCT01792284|Drug|LY2605541|
16148612|NCT01792284|Drug|Insulin Lispro|All participants will be administering insulin lispro SQ as their pre-meal insulin during the course of the trial.
16148613|NCT01792271|Other|Inhaled 7% HS (NaCl) home treatment|Administering inhaled 7% NaCl for two weeks of home treatment vs. a placebo of 0.12% NaCL during a separate home treatment period, and assessing the effects of each primarily by MCC study.
16148614|NCT01792258|Procedure|Percutaneous tracheostomy|Percutaneous tracheostomies will be performed with the kit commercially available in the current clinical practice.
16148615|NCT01792245|Device|Phototherapy|
16148616|NCT01792232|Other|Allergen|Subject specific allergen is placed in the lungs on day 1 of each triad
16148617|NCT01792232|Other|Saline|Saline will be placed in the lung on day 1 of each triad
16148618|NCT01792219|Other|Interprofessional collaboration in health care module|An educational module
16148619|NCT01792206|Drug|Zemplar|Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months
16148620|NCT01792206|Drug|Placebo|Zemplar 1 mcg or placebo to be taken once daily with breakfast for 3 months
16148621|NCT01792180|Behavioral|Mobility feedback device with use of instruction book|Weekly use of the mobility feedback device to measure gait speed. Two infrared sensors will be placed in the line of walking, a photo frame containing a display, symbols and lights will tell the participant when and how to perform the test. Gait speed is shown on the display and will serve as feedback to the participant. Participant can use their gait speed to decide which exercises from the instruction book he performs. Participants will be asked to keep an activity diary.
16148622|NCT01792167|Behavioral|Second Step Curriculum|social emotional learning program for 6th-8th graders. 15 50 minutes lessons in 6th grade, 13 50 minute lessons in 7th and 8th grade. covers empathy, perspective taking, anger management, impulse control, problem-solving, alcohol and drug prevention, sexual harassment, prejudice, bully prevention, bystander intervention
16148623|NCT01792115|Drug|Vitamin E 200 IU/d|Supplement-low dose
16148624|NCT01792115|Drug|Vitamin E 400 IU/d|Supplement-intermediate dose
16148625|NCT01792115|Drug|Vitamin E 800 IU/d|Supplement High Dose
16148626|NCT01792115|Behavioral|Diet and Exercise|Diet and Exercise for all Arms of the study at baseline
16148665|NCT01791868|Drug|Intravenous Sodium Valproate|According to randomization arm, patients will be treated either by intravenous sodium valproate (30 mg/kg during 15 min then 1 mg/kg/h during 12 h) or intravenous placebo. All included patients will benefit from first-line anti epileptic drugs and symptomatic medical care, in agreement with the French Experts Recommendation 2009(RFE 2009).
16148880|NCT01790087|Drug|ANX-188 Therapeutic Dose|
16148627|NCT01792102|Drug|Carfilzomib and Dexamethasone|"Phase 1: Carfilzomib will be administered at an escalating dose by cohort as 60-minute IV infusion on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. On Cycle 1 Days 1 and 2, carfilzomib will be given at 20 mg/m^2. For all subsequent doses, carfilzomib will be administered at the dose assigned to the cohort (56, 70, or 88 mg/m^2). Dexamethasone (8 mg IV or PO) will be administered prior to carfilzomib on Days 1, 2, 8, 9, 15, and 16.
~Phase 2: Carfilzomib will be administered at the MTD determined in phase 1. Maintenance: From Cycle 9 onward, carfilzomib and dexamethasone will be administered in the same fashion as during the previous treatment cycle, but only on days 1, 2, 15, and 16."
16148628|NCT01792089|Other|fat+protein meal|cream+ whey protein
16148629|NCT01792089|Other|Fat + protein + 13C fructose meal|cream+ whey protein +13C fructose
16148630|NCT01792089|Other|Fat+protein+13C fructose+glucose meal|Cream + whey protein + glucose:13C fructose mixture
16148631|NCT01792089|Other|13C Fat + whey protein|cream labelled with 13C palmitate + whey protein
16148632|NCT01792089|Other|13C Fat + whey protein + glucose+ glucose meal|cream labelled with 13C palmitate + whey protein + glucose:fructose mixture
16148633|NCT01792063|Drug|Sevoflurane|
16148634|NCT01792063|Drug|Sevoflurane|
16148635|NCT01792050|Drug|Docetaxel|Docetaxel chemotherapy regimen given by vein over 1 hour on day 8 of each cycle.
16148636|NCT01792050|Other|Placebo|Placebo taken orally every morning 1 hour prior to breakfast and 1 hour prior to dinner on days 1-14. Six pills to be taken each time for a total of 12 pills per day.
16148637|NCT01792050|Drug|Indoximod|Indoximod (1200 mg) taken orally every morning 1 hour prior to breakfast and 1 hour prior to dinner on days 1-14. Six 200 mg pills to be taken twice a day for a total of 12 pills per day.
16148638|NCT01792050|Drug|Paclitaxel|Paclitaxel chemotherapy regimen given by vein over 1 hour weekly x 3 followed by a week of rest each cycle.
16148639|NCT01792037|Drug|Etomidate|
16148640|NCT01792037|Drug|Midazolam|
16148641|NCT01792037|Drug|methylprednisolone|
16148642|NCT01792024|Device|Visualase Thermal Therapy|MR guided laser ablation of prostate cancer
16148643|NCT01792024|Procedure|magnetic resonance imaging|Undergo MR-guided LITT
16148644|NCT01792011|Device|PVI-guided fluid management|In this study of 25 adult patients undergoing OLT, we prospectively record PVIwithin 5 minutes during dissection and anhepatic phase of OLT by Masimo pulse oximeter.In this study of 25 adult patients undergoing OLT, we prospectively record study data within 5 minutes during dissection and anhepatic phase of OLT. Study data included measurements of PVI,thermodilution cardiac output, Stroke volume variation (SVV) and Pulse pressure variation (PPV).
16148645|NCT01791998|Procedure|magnetic resonance thermal imaging|Undergo MR-thermal image guided LITT
16148646|NCT01791998|Procedure|laser interstitial thermal therapy|Undergo MR-thermal image guided LITT
16148647|NCT01791985|Drug|AZD4547 / anastrozole or letrozole|"Patients will continue or restart the NSAI which they have progressed* on: either anastrozole (1mg) or letrozole (2.5mg), orally, once daily but together with twice daily AZD4547 (80mg).
~AZD4547 will be given on an intermittent schedule of one week on / one week off.
~*Prior to study entry, patients must have taken anastrozole or letrozole at some stage in their treatment to date for breast cancer; and shown evidence of resistance to this therapy. The NSAI does not have to be the most recent line of treatment."
16148648|NCT01791972|Drug|Albuterol Spiromax|Albuterol Spiromax is an inhalation-driven, multi-dose dry powder inhaler (DPI) containing a blend of albuterol sulfate with alpha-lactose monohydrate. Each actuation represents a dose of 90 mcg of albuterol sulfate. Participants received one dose of two inhalations (180 mcg).
16148649|NCT01791972|Drug|Placebo Spiromax|Placebo Spiromax is an inhalation-driven, multi-dose dry powder inhaler (DPI) delivering placebo to match the experimental drug. Participants received one dose of two inhalations.
16148650|NCT01791959|Dietary Supplement|synbiotic|2 symbiotics capsules per day for 28 weeks
16148651|NCT01791959|Other|placebo|2 Maltodexterin capsules as a placebo per day for 28 weeks
16148652|NCT01791946|Procedure|Binocular Treatment|The binocular treatment involves the completion of visual tasks via virtual reality goggles. The stimulus is presented to each eye separately, allowing for varying levels of contrast to be presented to each eye. (The visual task is therefore made more or less difficult with the variation of contrast presented to either eye.) Subjects will complete the computer-based visual tasks for approximately 36 hours total over the course of six weeks, or six hours per week for six weeks.
16148653|NCT01791946|Procedure|Sham Binocular Treatment|The sham treatment involves the same computer-based visual tasks and timeframe as the binocular treatment training but there will be no variation in contrast presentation to either eye.
16148654|NCT01791933|Drug|herbal medicine|120ml of Chuna herbal medicine(Ostericum koreanum, Eucommia ulmoides, Acanthopanax Sessiliflorus, Achyranthes bidentata, Psoralea corylifolia, Peucedanum japonicum, Cibotium barometz, Lycium chinense, Boschniakia rossica, and Cuscuta chinensis) taken twice a day 30 minutes after meals for more than 2 months
16148655|NCT01791933|Procedure|Chuna manual therapy|A type of Korean spinal manual therapy administered 5~10 minutes at physician's discretion 1-2times a week for more than 2 months Applies mobilization using High-Velocity, Low-Amplitude thrusts to joints slightly beyond the passive ROM and manual force within the passive ROM without thrusts.
16148656|NCT01791933|Procedure|Acupuncture|Acupuncture using sterilized disposable needles, sized 0.30X40mm. Needles left for 15~20 minutes, selecting 6 acupoints(both BL23, BL24, BL25 ) and other acupoints at physician's discretion, using a total of 10~20 acupoints 1-2times a week for more than 2 months
16148657|NCT01791933|Procedure|Bee-venom pharmacoacupuncture/pharmacoacupuncture|pharmacoacupuncture using 30G sterilized bee venom. Selecting 6 acupoints(both BL23, BL24, BL25) and other acupoints at physician's discretion, concentration 10,000:1, 0.1 cc per acupoint, total amount injected 1.0 cc/session 1-2times a week for more than 2 months
16148658|NCT01791920|Drug|Botulinum toxin type A(Botulax®)|Single administration, Day 0, 20 units
16148659|NCT01791920|Drug|Botulinum toxin type A(Botox®)|Single administration, Day 0, 20units
16148660|NCT01791907|Behavioral|Structured education in carbohydrate counting|
16148661|NCT01791907|Behavioral|Structured education in healthy food choices and low glycemic index|
16148662|NCT01791894|Drug|arsenic trioxide|Given IV
16148663|NCT01791881|Drug|Hugeltox|1.25U~2.5U/site, Maximum dosage 12.5U~60U/person
16148664|NCT01791881|Drug|Botulinum Toxin Type A(Botox®)|1.25U~2.5U/site, Maximum dosage 12.5U~60U/person
16148666|NCT01791868|Drug|Placebo|According to randomization arm, patients will be treated either by intravenous sodium valproate (30 mg/kg during 15 min then 1 mg/kg/h during 12 h) or intravenous placebo. All included patients will benefit from first-line anti epileptic drugs and symptomatic medical care, in agreement with the French Experts Recommendation 2009(RFE 2009).
16148667|NCT01791855|Drug|PF-04634817|Single 50 mg dose administered to subjects with normal renal function (creatinine clearance greater than or equal to 90 ml/min)
16148668|NCT01791855|Drug|PF-04634817|Single 50 mg dose administered to subjects with mild renal impairment (creatinine clearance 60-89 ml/min)
16148669|NCT01791855|Drug|PF-04634817|Single 50 mg dose administered to subjects with moderate renal impairment (creatinine clearance 30-59 ml/min)
16148670|NCT01791855|Drug|PF-04634817|Single 50 mg dose administered to subjects with severe renal impairment (creatinine clearance 15-29 ml/min)
16148671|NCT01791842|Drug|Tocilizumab|8 mg/kg/month
16148672|NCT01791842|Drug|Placebo|
16148673|NCT01791816|Drug|Phenylephrine|"Phenylephrine dose-response comprises infusion of 0.5, 1, 2, 3, 4 micrograms/kg/min for 10 min at each dose.
~If bloods pressure increases by 30% or if heart rate decreases below 40 beats per minute we will stop infusion."
16148674|NCT01791816|Drug|L-Ng-monomethyl Arginine (L-NMMA)|Systemic L-NMMA is infused as a 500μg/kg/min loading dose for 15 min followed by a 50μg/kg/min maintenance dose for the remainder of the experiment.
16148675|NCT01791803|Behavioral|hypnotherapy|One 90 minute session within 2 weeks of hospital discharge
16148676|NCT01791803|Drug|Nicotine|free one month supply after hospital discharge
16148677|NCT01791790|Device|Stimulation|
16148678|NCT01791790|Device|SHAM|no stimulation
16148679|NCT01791777|Behavioral|SafeCare Coaching|This study involves a comparison of different coaching models for providers who are newly trained to conduct an evidence-based parent training program (SafeCare). As part of all SafeCare trainings, all providers receive workshop training plus ongoing coaching to promote adherence to the intervention model. This research is aimed at understanding the coaching aspect of the training and dissemination processes, with the goal of implementing the most effective and efficient dissemination processes. One group of home visitors will be coached directly by NSTRC trainers, who work for NSTRC. The other group of home visitors will receive coaching that is provided by a staff member who works for the local social service agency.
16148680|NCT01791751|Drug|Clomifene Citrate|Clomiphene citrate 100 mg daily for 5 days
16148681|NCT01791738|Procedure|Acetabular positioning system|Pre-operative planning through 3D software with design and fabrication of patient specific instruments for placement of a guide pin to be used to aid in bone preparation for insertion of an acetabular cup in total hip arthroplasty
16148682|NCT01791725|Drug|ELND005|
16148683|NCT01791725|Drug|Placebo|
16148684|NCT01791712|Procedure|On-line hemodiafiltration|pre-dilution 40% of blood flow rate blood flow rate 300-350 ml/min dialysate flow rate 800 ml/min
16148685|NCT01791712|Procedure|High-flux Hemodialysis|blood flow rate 300-350 ml/min dialysate flow rate 800 ml/min
16148686|NCT01791699|Drug|Moxonidine|
16148687|NCT01791699|Drug|Placebo|
16148688|NCT01791686|Drug|CDX-1135|
16148689|NCT01791673|Device|Ultrasound glaucoma treatment|Ultrasound glaucoma treatment with EYEOP1 device
16148690|NCT01791660|Device|Zeltiq Coolsculpting System|Non-invasive device designed to cool subcutaneous fat without affecting adjacent or underlying structures.
16148691|NCT01791647|Drug|metformin 1500 mg|
16148692|NCT01791647|Drug|myoinositol 1500 mg|
16148693|NCT01791634|Procedure|proximal chevron osteotomy|
16148694|NCT01791634|Procedure|proximal open wedge osteotomy with LPS system|
16148695|NCT01791621|Other|Elimination/Challenge Diet|"An pre-specified elimination diet contains a list of food items permitted to be consumed by the study participants. These food items, selected to be consumed are whole foods of low allergenicity.
~The challenge phase of the diet involves introducing 8 different foods at three days intervals. the selected challenge foods will be selected based on a review of the non-IgE mediated food allergy test results by a third-party, not directly associated with the project team."
16148696|NCT01791608|Dietary Supplement|Zinc sulfate as dietary supplementation|Zinc sulfate as dietary supplementation
16148697|NCT01791608|Dietary Supplement|Zinc amino acid chelate as dietary supplementation|Zinc amino acid chelate as dietary supplementation
16148698|NCT01791608|Dietary Supplement|Milk without fortification without zinc|Milk without fortification
16148699|NCT01791595|Drug|AZD3965|AZD3965 is available as 5, 10, 20 and 30mg capsules and patients took their dose orally once or twice every day of each 28 day cycle including a single dosing day at day-7 prior to Cycle 1 in Part 1 of the study. The RP2D for Part 2 of the study is 10mg BID. Patients can have up to 12 cycles of treatment if patient is benefitting.
16148700|NCT01791556|Other|HIV-1 viral load testing|
16148701|NCT01791543|Device|Intramural Needle Ablation Catheter|
16148702|NCT01791517|Other|Solution 1 (Test)|Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to all four lens care solution in a random order
16148703|NCT01791517|Other|Solution 2 (Test)|Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
16148704|NCT01791517|Other|Solution 3 (Test)|Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
16148705|NCT01791517|Other|Solution 4 (Control)|Each subject, for each lens type (Lens A, Lens B or Lens C) will be exposed to each lens care solution in a random order
16148706|NCT01791504|Device|TissuGlu Surgical Adhesive|Standard Wound Closure Techniques Plus TissuGlu and no drains.
16148707|NCT01791491|Drug|Belatacept|Single intravenous infusion of belatacept, 7.5 mg/kg
16148708|NCT01791478|Drug|PI3K inhibitor BYL719|Given PO
16148709|NCT01791478|Drug|letrozole|Given PO
16148710|NCT01791478|Other|laboratory biomarker analysis|Correlative studies
16148711|NCT01791478|Other|pharmacological studies|Correlative studies
16148712|NCT01791465|Drug|extended-release exenatide|Single arm study - 2mg Bydureon every 7 days x 16 weeks
16148713|NCT01791439|Other|lidocaine|Application of lidocaine to the glossopharyngeal nerve.
16148714|NCT01791439|Other|placebo|
16148715|NCT01791426|Device|Artelac Rebalance|Instill 1 drop of the Artelac Rebalance eye drops in each eye 3 to 5 times per day for 90(± 10) day treatment.
16148717|NCT01791413|Drug|depot medroxyprogesterone acetate|DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks)
16148718|NCT01791400|Drug|metoclopramide, injection,20mg, one time|metoclopramide, intravenous injection,20mg, one time
16148719|NCT01791400|Drug|Sumatriptan, injection, 6 mg, one time|Sumatriptan, subcutaneous injection, 6 mg, one time
16148720|NCT01791387|Drug|Dovitinib|"Patients will be treated with dovitinib (500 mg orally, once daily 5 days on/2 days off) until disease progression, intolerability, patient refusal, death or study drug discontinuation for any other reason. Dovitinib should be ingested at least 1 hour prior to a meal or at least 2 hours following a meal at approximately the same time each day.
~If patients cannot tolerate the protocol-specified dosing schedule, dose reductions or treatment interruptions are permitted. When necessary, dovitinib may be reduced to 400 mg for 5 days on/2 days off. If an additional dose reduction is required, dovitinib may be reduced to 300 mg dose 5 days on/2 days off. Once dose is reduced due to an adverse event, it cannot be re-escalated. Patients are allowed only 2 dose reductions."
16148721|NCT01791374|Drug|Rilotumumab|Rilotumumab is a fully human monoclonal antibody immunoglobulin G, type 2 (IgG2) against human hepatocyte growth factor/scatter (HGF/SF) that blocks binding of HGF/SF to its receptor MET, inhibiting HGF/MET-driven activities in cells.
16148722|NCT01791374|Drug|Rilotumumab|Drug: Rilotumumab Rilotumumab is a fully human monoclonal antibody immunoglobulin G, type 2 (IgG2) against human hepatocyte growth factor/scatter (HGF/SF) that blocks binding of HGF/SF to its receptor MET, inhibiting HGF/MET-driven activities in cells. Drug: Cisplatin A platinum containing chemo-therapy compound that reacts in vivo, binding to and causing crosslinking of DNA, which ultimately triggers apoptosis (programmed cell death). Drug: Capecitabine A chemo-therapy prodrug, that is enzymatically converted to 5-fluorouracil in the tumor, where it inhibits DNA synthesis and slows growth of tumor tissue.
16148723|NCT01791361|Other|Other|No intervention other than routine medical care
16148724|NCT01791348|Other|d2 test of attention|
16148725|NCT01791309|Drug|combination panitumumab and vemurafenib|Treatment will consist of panitumumab 6mg/kg IV every 14 days and vemurafenib 960mg orally twice daily. In patients who initially respond to treatment and later progress, a voluntary biopsy will be requested at the time of relapse to study mechanisms of acquired resistance. This biopsy should consist of at least one frozen core specimen. Every effort will be made to obtain this biopsy within 30 days of discontinuation of treatment and before the initiation of any new tumor-directed therapies.
16148726|NCT01791296|Drug|Dexmedetomidine|At 21:30h, all current IV sedatives (whether continuous or intermittent) will be decreased by 50% and study drug started at 0.2 mcg/kg/hour at 21h30 to allow sleep between 22h00 and 6h00. Study infusion will be halved at 6:00am and d/c at 6:15am. The infusion rate will be increased by 0.1mcg/kg/hour every 15 minutes when the Riker-SAS is ≥ 4 up to a maximum rate of 0.7 mcg/kg/hr until the targeted sedation goal of a Riker-SAS of 3 is reached. For agitation (ie., Riker-SAS ≥ 5), 'as needed' IV midazolam (1-5 mg IV q1h prn agitation) may be administered during the upwards titration of the study medication. Administration of any dose of as needed IV midazolam will result in the increase of the study medication by 0.1 mcg/kg/hr when ≥ 15 minutes have elapsed since the last upwards titration.
16148727|NCT01791296|Other|Placebo|At 21:30h, all current IV sedatives (whether continuous or intermittent) will be decreased by 50% and study drug started at 0.2 mcg/kg/hour at 21h30 to allow sleep between 22h00 and 6h00. Study infusion will be halved at 6:00am and d/c at 6:15am. The infusion rate will be increased by 0.1mcg/kg/hour every 15 minutes when the Riker-SAS is ≥ 4 up to a maximum rate of 0.7 mcg/kg/hr until the targeted sedation goal of a Riker-SAS of 3 is reached. For agitation (ie., Riker-SAS ≥ 5), 'as needed' IV midazolam (1-5 mg IV q1h prn agitation) may be administered during the upwards titration of the study medication. Administration of any dose of as needed IV midazolam will result in the increase of the study medication by 0.1 mcg/kg/hr when ≥ 15 minutes have elapsed since the last upwards titration.
16148728|NCT01791283|Procedure|Arterial waveform analysis, esofageal doppler, transthoracal cardiac ultrasound, Cardiac magnetic resonance imaging.|
16148729|NCT01791270|Device|Continuous positive airway pressure (CPAP) therapy|"Device: CPAP accordingly to the normal therapy in daily practice. In the group of 61 patients with OSA: we compared the results before and after three months of correct treatment with CPAP.
~First, an automatic continuous positive airway pressure device (autoCPAP REMstar) was used to evaluate the pressure titration by night registration at patient home. AutoCPAP gets complete information about the optimum level to be set as therapeutic (CPAP pressure).
~The patient has been reevaluated periodically in the outpatient Sleep Unit to verify proper adaptation and compliance of CPAP.
~We considered a proper compliance when patients used CPAP ≥ 4 hours/day. This data has been extracted from the counter included in the CPAP compressor.
~Procedures:
~- Respiratory Polygraphy
~- Ambulatory Blood Pressure Monitoring
~- Endothelial dysfunction, by determining the hyperaemic response to ischemia using a Laser-Doppler flowmeter.
~- ß1en subunit expression in peripheral blood leukocytes."
16148730|NCT01791244|Drug|Rebif®|
16148731|NCT01791231|Drug|Radiolabelled 14C-canagliflozin (14C-JNJ-28431754)|A single oral dose of 196 mg radiolabeled 14C-canagliflozin (14C-JNJ-28431754) liquid suspension containing approximately 40 microcurie (1480 kBq) of 14C radioactivity will be administered on Day 1.
16148732|NCT01791218|Procedure|CABG, AVR or CABG+AVR and PVI|
16148733|NCT01791218|Procedure|CABG, AVR or CABG+AVR|
16148734|NCT01791192|Drug|FTY720|Fingolimod
16148735|NCT01791192|Drug|Oral Corticosteroid|Oral Corticosteroid
16148736|NCT01791179|Behavioral|Comprehensive substance abuse services|
16148737|NCT01791166|Biological|Blood test for detecting the circulatory anti-HLA antibodies by ELISA and LUMINEX tests|
16148738|NCT01791153|Drug|Tocilizumab|Tocilizumab will be administered at a dose of 162 mg as SC injection qw or q2w for 52 weeks in Part 1 of the study and at a dose 162 mg as SC injection qw for 104 week at the discretion of the investigator in Part 2 of the study.
16148739|NCT01791153|Drug|Prednisone|Prednisone will be administered at tapering oral doses as tablets daily for 26 or 52 weeks according to the protocol-defined schedule in Part 1 of the study. Prednisone will also be administered as escape therapy to treat disease flares in an open-label manner during Part 1 at a dose and duration selected by the investigator.
16148740|NCT01791153|Drug|Tocilizumab Placebo|Tocilizumab placebo will be administered as SC injection qw or q2w for 52 weeks in Part 1 of the study.
16148741|NCT01791153|Drug|Prednisone Placebo|Prednisone placebo will be administered as tablets orally daily according to the protocol-defined schedule (from Week 26 to Week 52) in Part 1 of the study.
16148742|NCT01791153|Drug|Corticosteroids|Participants without sustained remission at Week 52 will receive corticosteroids at a dose and schedule at the discretion of the investigator for a maximum of 104 weeks.
16148743|NCT01791153|Drug|Methotrexate|Participants without sustained remission at Week 52 will receive methotrexate at a dose and schedule at the discretion of the investigator for a maximum of 104 weeks.
16148744|NCT01791127|Device|market-released BIOTRONIK pacemaker system including one or two Siello S leads.|
16148745|NCT01791114|Other|Cold exposure|For the cold exposure trial, the subjects will follow an individualized cold exposure protocol maximize the elicited non-shivering thermogenesis. Subjects will be wearing liquid conditioned garments (Polar Products Inc, Stow, OH). The temperature will initially be set at 18°C, then decreased at 1 degree celsius intervals thought the air- conditioned temperature control bath until subjects report shivering. Electromyography (EMG; Delsys, Bagnoli 8, Boston, MA) will be performed continuously to verify shivering muscle activity. Upon shivering, the temperature will be increased by 1degree Celsius intervals until shivering resides. Subjects' core temperature will be measured at 10-second intervals with the use of a telemetric pill (Core Temp Inc., Palmetto, FL).
16148746|NCT01791114|Other|Cold exposure plus propranolol|For the cold exposure plus propanol trial, temperature will be titrated as previously described. The non-selective beta-adrenergic antagonist propranolol (0.5mg/kg and up to 40) will be given orally before the beginning of the study and again after 4-6 hours. In case participant's heart rate after propranolol administration decreases below 50 beats per min or systolic blood pressure below 90 mmHg second dose of propranolol will not be administered. Heart rate and blood pressure will be monitored continuously throughout the study. Propranolol doses up to 80 mg have been shown to significantly reduce fludeoxyglucose (FDG) uptake in brown fat in clinical patients.
16148747|NCT01791114|Other|Thermoneutral Conditions|Subjects will be exposed to thermoneutral conditions (26 - 28°C)
16148748|NCT01791114|Other|Cold water consumption|Subjects will be asked to consume cold water (4 °C,10 ml/ kg body weight within 10 minutes)
16148749|NCT01791114|Other|Tepid water consumption|Subjects will be asked to consume cold water (36 C,10 ml/ kg body weight within 10 minutes)
16148750|NCT01791114|Other|Exercise|Subject will be asked to complete four bouts of exercise for 10 min- at 85% of their maximal oxygen consumption (VO2max) with 15-min breaks between each bout
16148751|NCT01791114|Other|Meal consumption|Subjects will be asked to consume a high calorie meal (12 kcal/kg, 50% carbohydrates, 30% fat, and 20% protein) within 15 minutes.
16148752|NCT01791101|Drug|Eltrombopag|
16148753|NCT01791088|Drug|sirolimus|Given PO
16148754|NCT01791088|Other|pharmacological study|Correlative studies
16148755|NCT01791088|Other|laboratory biomarker analysis|Correlative studies
16148756|NCT01791075|Device|Tan Endoglide|Patients assigned to this intervention will have their endothelial donor graft injected into the anterior chamber using the Tan Endoglide
16148757|NCT01791075|Device|Endosaver|Patients assigned to this intervention will have their endothelial donor graft injected into the anterior chamber using the Tan Endoglide
16148758|NCT01791062|Device|HYTOP®|HYTOP® will be implanted once during surgery.
16148759|NCT01791049|Drug|TD-1607|
16148760|NCT01791049|Drug|Placebo|
16148761|NCT01791036|Procedure|Adductor Canal Block|Examination of the adductor canal using ultrasound will be performed using a high frequency linear probe. Following this the ultrasound probe will be positioned perpendicular to the skin in the medial upper-thigh region. The ultrasound probe will be moved either cephalad or caudad from its initial position in order to visualize the femoral artery immediately deep to the middle of the sartorius muscle. This point will then be selected as the appropriate level for needle insertion. Sham blocks using subcutaneous injection of normal saline will be used in both groups to maintain patient blinding.
16148762|NCT01791036|Procedure|Femoral Nerve Block|Examination of the femoral nerve using ultrasound will be performed using a high frequency linear probe. Following this the ultrasound probe will be positioned perpendicular to the skin at the level of the femoral crease. The femoral artery will be identified and the femoral nerve will then be located immediately lateral to the artery, deep to the fascia iliaca and superficial to the iliopsoas muscle. The needle will be positioned next to the femoral nerve. Following this 20 ml of 0.25% bupivacaine with epinephrine will be injected incrementally over a 1 to 2 minute period. Sham blocks using subcutaneous injection of normal saline will be used in both groups to maintain patient blinding.
16148763|NCT01791023|Other|Physical exercise|30 minutes of aerobic exercise on treadmill with moderate intensity.
16148764|NCT01791010|Other|Inspiratory muscle training|
16148765|NCT01791010|Other|Training sham|Conducting fake training with the aim of blind the control group
16148766|NCT01790997|Drug|DLBS1033|1 tablet of DLBS1033 490 mg thrice daily, after meal
16148767|NCT01790997|Drug|Aspirin|1 tablet of aspirin 80 mg once daily, after meal
16148768|NCT01790997|Drug|Clopidogrel|1 tablet of clopidogrel 75 mg once daily, after meal
16148769|NCT01790984|Other|High sugar low starch diet|
16148770|NCT01790984|Other|Low sugar high starch diet|
16148771|NCT01790971|Drug|Intrathecal Morphine|Depending on the randomization schedule, 100μg of morphine will or will not be added to the intrathecal mixture.
16148772|NCT01790971|Drug|No Intrathecal Morphine|Depending on the randomization schedule, 100μg of morphine will or will not be added to the intrathecal mixture.
16148773|NCT01790932|Drug|BKM120|
16148774|NCT01790919|Behavioral|Cognitive therapy for depression|"Cognitive therapy (CT) for depression. There is evidence that CT for major depressive disorder (MDD) can be as effective as antidepressant medication for the initial treatment of moderate to severe MDD. Moreover, following the withdrawal of treatment, patients treated with CT are significantly less likely to relapse than patients treated with antidepressant medication and CT is at least as effective as antidepressant medication in preventing subsequent relapse. Over 14 sessions CT aims to alter the symptomatic expression of depression and reduce risk for subsequent episodes by correcting the negative beliefs and maladaptive information processing presumed to underlie the disorder and alter the systematic tendency to misperceive reality in a pessimistic fashion.
~Cognitive support. An intervention to improve memory for the contents of therapy. Cognitive support involves a series of specific procedures that support the encoding and retrieval stages of an episodic memory."
16148881|NCT01790087|Drug|ANX-188 Supratherapeutic dose|
16148882|NCT01790087|Drug|Saline|
16148775|NCT01790906|Procedure|RSD|Contrast renal angiography was performed to localize and assess the renal arteries for accessibility and appropriateness for RSD .once the anatomy was deemed acceptable, the internally irrigated radiofrequency ablation catheter(Celsius Thermocool,Biosense Webster,Diamond Bar,California)was introduced into each renal artery.then was maneuvered within the renal artery to allow energy delivery in a circumferential,longitudinally staggered manner to minimize the chance of renal artery stenosis.About six to nine ablation at 10W for 1 min each were performed in both renal arteries.during ablation, the catheter system monitored tip temperature and impedance,altering radiofrequency energy delivery in response to predetermined algorithm.
16148776|NCT01790906|Other|Conventional therapy|Optimizing drug therapy,included angiotensin-converting enzyme inhibitors,aldosterone antagonist,beta-receptor blockers,diuretic,digoxin and so on.The patients with chronic heart failure ,whos'condition need for CRT-D(cardiac resynchronization therapy )/ICD(implantable cardioverter-defibrillator),are considered to implant CRT/ICD .CRT is abbreviation for cardiac resynchronization therapy ,ICD is defined for Implantable Cardioverter defibrillator.
16148777|NCT01790893|Drug|aflibercept|
16148778|NCT01790880|Behavioral|ORLA|Practice on ORLA (Oral Reading for Language in Aphasia), a computer-based virtual therapy system.
16148779|NCT01790880|Behavioral|ORLA + Writing|Treatment includes writing of sentences in combination with ORLA
16148780|NCT01790854|Drug|Prasugrel dose 5 mg/day|
16148781|NCT01790854|Drug|Prasugrel dose 10 mg/day|
16148782|NCT01790841|Device|Iforia/Ilesto ICD/CRT-D, Linox smart DF4 lead/ Protego|
16148783|NCT01790828|Drug|Xyntha : coagulation factor IIIV (recombinant)|Xyntha will be administered according to physician's discretion.
16148784|NCT01790802|Device|2RT nanosecond laser|active laser therapy
16148785|NCT01790789|Behavioral|Daily stress reduction program|Subjects will participate in activities of a daily stress reduction program.
16148786|NCT01790789|Other|Attention control|Subjects will receive periodic phone calls to review study protocol and will receive stress reduction program materials at the end of the study.
16148787|NCT01790776|Radiation|Urografin 30%|"Urografin 30% (Natrium amidotrizoas 10G, Megalumin, Amidotrizoas 65G, Natrii calcii edetas, water for injection 250 ml, with 146 mg iodium/ml).
~The tip of a bladder catheter is placed at the external urethral meatus and fixed at this location. The solution (urografin 30 %) is instilled."
16148788|NCT01790776|Radiation|NaCl 0,9 % in aqua|The tip of a bladder catheter is placed at the external urethral meatus and fixed at this location. The solution (NaCl 0,9 % in aqua) is instilled. If the result is inconclusive, urografin 30 % will be instilled.
16148789|NCT01790763|Device|Keramatrix|Dressing for second degree burn
16148790|NCT01790763|Device|Mepilex|Dressing for second degree wound
16148791|NCT01790750|Device|PES first, then FFES|A 5-minute Pocket echocardiography system scan (PES) scan will be performed to detect PDA on neonates. This scan will be followed by a Full Featured Echocardiography System Scan (FFES) and scan results will be compared.
16148792|NCT01790737|Drug|Cyclophosphamide|
16148793|NCT01790737|Drug|Filgrastim|
16148794|NCT01790724|Behavioral|Walking exercise|
16148795|NCT01790711|Procedure|FMT through mid-gut|
16148796|NCT01790685|Drug|dexamethasone implant|
16148797|NCT01790672|Dietary Supplement|Ethanol|Vodka Absolut
16148798|NCT01790672|Other|Water|Lemon-flavored water
16148799|NCT01790672|Dietary Supplement|Alcoholized wine|Wine 13º or wine 8º
16148800|NCT01790672|Dietary Supplement|De-alcoholized wine|Wine 0º
16148801|NCT01790659|Drug|WR 279,396|WR 279,396 is a topical cream of paromomycin 15% and gentamicin 0.5%
16148802|NCT01790659|Drug|Paromomycin|Paromomycin alone
16148803|NCT01790646|Other|intubation|intubation using Glidescope videolaryngoscope
16148804|NCT01790633|Other|ELISA|Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg), anti-HBsAg antibody (anti-HBs Ab), anti-HCV antibody, and anti-HIV antibody status. Results will be given after test results are available (8-10 days).
16148805|NCT01790633|Other|Rapid Test|A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®), anti-HCV antibody (HCV, using OraQuick®), and anti-HIV antibody (HIV, using VIKIA®) status. Results will be given the same day.
16148806|NCT01790620|Other|CVVHD|CVVHD will be used during 72 hours with a prescribed dose of 30 ml/Kg/h Prismasol® 4 as dialysate fluid. Blood flow of 200-250 ml/min, to achieve 12 - 15 L/h will be prescribed. Isovolemic CRRT will be encouraged during this 72 hours if volume overload status is not present. After 72 hours, CVVHD will be continued and dialysate dose (ml/kg/h) will be adjusted to achieve creatinine levels between 80-120 umol/L until patient recovers urine output and / or tolerates intermittent hemodialysis.
16148807|NCT01790620|Other|CVVH|CVVH will be used during 72 hours with a prescribed dose of 30 ml/Kg/h Prismasol® 4 as reposition fluid. Blood flow of 200-250 ml/min, to achieve 12 - 15 L/h will be prescribed adjusting the adequate percentage of prefilter reinfusion to maintain a theorical filtration fraction between 18-22%. Isovolemic CRRT will be encouraged if volume overload status is not present. After 72 hours, CVVH will be continued and filtration dose (ml/kg/h) will be adjusted to achieve creatinine levels between 80-120 umol/L until patient recovers urine output and / or tolerates intermittent hemodialysis.
16148808|NCT01790607|Drug|ONO-2745 /CNS 7056|
16148809|NCT01790594|Biological|Belatacept|The first dose of belatacept will be administered approximately 24-48 hours after the last dose of Anti-Thymocyte Globulin (Rabbit).
16148810|NCT01790594|Drug|methylprednisolone|
16148811|NCT01790594|Biological|Anti-thymocyte Globulin (Rabbit)|
16148812|NCT01790594|Drug|Tacrolimus|There may be an opportunity to withdraw tacrolimus at week 40
16148813|NCT01790594|Drug|Mycophenolate mofetil|Mycophenolate mofetil will be administered at a target dose of 1000 mg by mouth twice daily (e.g., BID) beginning on the day of surgery or post-operative day 1 depending upon when during the day the surgery is completed (maximum MMF dosing is 2G per day). MMF will be adjusted based on clinical complications (such as neutropenia). Myfortic® (mycophenolate sodium) may be used as a replacement for MMF. Mycophenolate sodium will be dosed at 720 mg PO BID. Mycophenolate sodium will be adjusted based on clinical complications.
16148883|NCT01790087|Drug|Moxifloxacin|
16148884|NCT01790074|Other|TrP therapy|TrP manual therapy comprises different manual approaches, e.g., compression, stretching, or transverse friction massage applied over active TrPs in the sternocleidomastoid muscle
16148814|NCT01790581|Behavioral|Balance Training|This is a 4-week supervised balance training program that has been previously validated in those with CAI by improving subjective and objective measures of function. During the 4-week program, subjects will complete three 20-25 minute sessions a week for a total of twelve supervised training sessions. The specific exercises and repetitions that will be performed per training session will include: 1) hop to stabilization (10 repetitions per direction), 2) hop to stabilization and reach (5 repetitions per direction), 3) unanticipated hop to stabilization (3 repetitions), 4) progressive single limb stance balance activities (3 repetitions), and 5) progressive single limb stance activities with eyes closed (3 repetitions).
16148815|NCT01790581|Behavioral|STARS|The STARS intervention will consist of 4 unique sensory-targeted interventions: calf stretching, ankle joint traction, anterior/posterior ankle joint mobilizations, and plantar massage. These four techniques target 3 types of sensory pathways (musculotendinous, articular, and plantar cutaneous, respectively) and will be applied in the same order for all treatment sessions: 1) 60-second calf stretch, 2) 30-second ankle traction, 3) 30-second mobilization, 4) 2-minute plantar massage, 5) 30-second ankle traction, and 6) 30-second mobilization.
16148816|NCT01790568|Drug|Vorinostat|administered at a dose of 100 mg orally, twice daily starting on day -10 in order to achieve steady-state prior to beginning the conditioning chemotherapy, and continued after transplant (day 0) until day +100.
16148817|NCT01790568|Drug|Tacrolimus|
16148818|NCT01790568|Drug|Methotrexate|
16148819|NCT01790555|Drug|Namisol|
16148820|NCT01790555|Drug|Diazepam/placebo|
16148821|NCT01790542|Other|Iron fortified cereal|Infants will be assigned to one of the three interventions: A (iron fortified cereal), B (iron fortified cereal with fruit), C (Meat)
16148822|NCT01790542|Other|Iron fortified cereal with fruit|
16148823|NCT01790542|Other|Meat|
16148824|NCT01790529|Procedure|Early administration of SAP (Cefuroxime (plus metronidazole in colorectal surgery)) in anesthetic room (75 to 30 minutes prior to skin incision)|
16148825|NCT01790529|Procedure|Late administration of SAP (Cefuroxime (plus metronidazole in colorectal surgery)) in the operating theatre (within 30 minutes prior to skin incision)|
16148826|NCT01790516|Drug|Cisplatin|Cisplatin 100 mg/m2 during weeks 1,4, and 7 of radiation therapy
16148827|NCT01790516|Drug|cetuximab|Cetuximab beginning at a dose of 400 mg/m2 the week before radiation commences and then 250 mg/m2 weekly during weeks 1 and 7 of radiation.
16148828|NCT01790516|Radiation|Radiation|daily radiation for 7 weeks
16148829|NCT01790503|Drug|PLX3397|
16148830|NCT01790503|Radiation|Radiation Therapy|
16148831|NCT01790503|Drug|Temozolomide|
16148832|NCT01790490|Drug|Ketamine 0.41 mg/kg|52 minute iv infusion of ketamine 0.41 mg/kg
16148833|NCT01790490|Drug|Ketamine 0.71 mg/kg|52 minute iv infusion of ketamine 0.71 mg/kg. This dose follows K1 in all 3 orderings.
16148834|NCT01790490|Drug|Lorazepam 2 mg|52 minute infusion of lorazepam 2 mg. This serves as an active control.
16148835|NCT01790477|Procedure|Auricular Acupuncture|Application of auricular acupuncture to 5 points on the ear
16148836|NCT01790464|Drug|2% Lidocaine|2% lidocaine and peritonsillar instillation of gauze soaked with 2% lidocaine (Glossopharyngeal Group).
16148837|NCT01790464|Drug|placebo|
16148838|NCT01790451|Procedure|Irreversible Electroporation|
16148839|NCT01790438|Drug|LY2605541|
16148840|NCT01790438|Drug|Human Insulin NPH|
16148841|NCT01790438|Drug|Oral Antihyperglycemic Medications (OAM)|
16148842|NCT01790425|Procedure|to infuse water into colon to open the lumen for water infusion colonoscopy|
16148843|NCT01790425|Procedure|Air colonoscopy|
16148844|NCT01790412|Behavioral|Exercise group|Combined two land aerobic sessions and one aquatic activities session
16148845|NCT01790399|Procedure|Excision of sentinel node(s)|Excision of sentinel node(s) using SENTIMAG / SIENNA + in addition to the usual method (blue and /or radioactive product)
16148846|NCT01790373|Behavioral|Suubi+Adherence|"Matched savings accounts/child development accounts (CDAs) for the adolescents held in a local bank.
~Financial education and workshops on asset-building, future planning, and protection from risks
~Mentorship from a young adult/near-peer
~Family-based microenterprise development training
~Medical Event Monitoring System
~Bolstered Standard of Care: Adherence Counseling Practices
~-Four to six counseling sessions to review HIV, ART, resistance, and adherence.
~Medical Standard of Care:
~-Pediatric ART initiation and monitoring followed by all public clinics, and outlined in National Department of Health Guidelines for pediatric HIV care in Uganda
~Psychosocial Standard of Care:
~-Psychosocial support provided by lay counselors trained in standardized ART adherence counseling"
16148847|NCT01790373|Behavioral|Bolstered Standard of Care|"-Medical Event Monitoring System
~Bolstered Standard of Care: Adherence Counseling Practices
~-Four to six counseling sessions to review HIV, ART, resistance, and adherence.
~Medical Standard of Care:
~-Pediatric ART initiation and monitoring followed by all public clinics, and outlined in National Department of Health Guidelines for pediatric HIV care in Uganda
~Psychosocial Standard of Care:
~-Psychosocial support provided by lay counselors trained in standardized ART adherence counseling"
16148848|NCT01790360|Behavioral|Patient Navigation (PN) Intervention|Patient Navigation is defined as an individual relationship between a navigator and participant to promote retention in the continuum of HIV care . For this study, three experienced navigators will be hired. Their primary role will be to ensure that participants are linked to an HIV primary care provider, that they attend at least one scheduled visit within three months of receiving a confirmed HIV diagnosis, and that they are retained in care (as defined by attending three HIV visits within nine months of diagnosis). To promote linkage to HIV care, navigators will help participants identify material and other barriers to accessing care and will work with participants to overcome those barriers.
16148849|NCT01790360|Behavioral|Financial Incentives (FI) Intervention|After confirmation that they have completed their first HIV primary care visit, Financial Incentive participants will receive a gift card. Additionally, the coordinator will flip a coin and give participants a bonus gift card if the coin flip comes up heads. Participants who attend the second HIV primary care visit will receive a gift card. Patients who attend a third HIV primary care visit will receive a gift card. Study staff will be responsible for confirming participants' attendance at appointments.
16148885|NCT01790074|Other|TrP manual control therapy|The treatment consisted of a simulation of the same TrP therapy treatment applied to the experimental group without the application of any therapeutic pressure.
16148850|NCT01790347|Behavioral|Exercise group|"The physical conditioning program included a total of three 50-55 minute sessions per week. Pregnant women started at 9 weeks and finished at 38-39 weeks, therefore, an average of 85 training sessions were planned for each participant. All subjects wore a heart rate (HR) monitor (Polar FT7, Finland) during the training sessions to ensure that the exercise intensity was light to moderate.
~Each session included 10 min of warm up and 10 min of cool down which included an specific pelvic floor muscles training. The core section of the exercise session lasted from 25 to 30 min and included moderate-intensity aerobic exercises once a week and resistance exercises twice a week."
16148851|NCT01790334|Other|Ultrasonography|
16148852|NCT01790321|Device|LSF-filtering device|LifeStraw Family is a water purification device that by means of hollow fibres removes solid particles (<0.5 NTU turbidity reduction), bacteria (>Log 6 reduction), viruses (>Log 4 reduction) and cysts (>Log 3 reduction). Zinc fortification is provided by a chamber housing a zinc releasing glass-plate that is placed annexed to the hollow fibre column. It is estimated that the LSF can provide about 5 mg of zinc/l of filtered water. By consuming daily a portion of 0.6 litres of enriched water, >100% of the age-specific estimated physiologic requirement would be covered, assuming a fractional absorption of 40%.
16148853|NCT01790308|Drug|CSII|continuous subcutaneous insulin infusion for 2~4 weeks
16148854|NCT01790308|Drug|Liraglutide|CSII for 2~4 weeks combined with Liraglutide 0.6mg/d for 1 month and 1.2mg/d for next 2 months
16148855|NCT01790295|Drug|Ruxolitinib Pre- Hematopoietic cell transplantation (HCT)|Ruxolitinib (INC424) tablets will be started 60 days (day -65) prior to start of conditioning chemotherapy. The starting dose of Ruxolitinib will be determined according to baseline platelet count and will be modified according to platelet count at follow-up. The drug will be given in the maximum tolerated dose as defined in the protocol for 56 days, followed by 4 days of taper, and will be stopped completely at the planned start of conditioning therapy (starting on day -5) i.e. 5 days prior to stem cell infusion. The drug will be supplied as 5 mg tablets.
16148856|NCT01790282|Drug|estradiol plus progesterone 100 mg IM injection|estradile valaerate 2mg plus progesterone 100 mg/day support arm :E2 valerate 2mg three times /day are given to the arm cases plus P4 100 IM/day for 14 days starting on day of ovum pickup and single IM injection of 0.1 mg decapeptyl on day of ET
16148857|NCT01790282|Drug|Progesterone IM of 100 mg|Starting on day of ovum pickup ICSI cases are given prontogest 100 mg IM /day plus single dose dose of treptorline 0.1mg is given sc on day of embryo transfer
16148858|NCT01790256|Device|Cereve Sleep System at 30 degrees C|
16148859|NCT01790256|Device|Cereve Sleep System at 14-16 degrees C|
16148860|NCT01790243|Device|Lutonix Drug Coated Balloon|Use of the Lutonix Drug Coated Balloon (DCB) for the treatment of stenosis or occlusion of the femoropopliteal arteries.
16148861|NCT01790243|Device|Standard PTA Balloon|Use of Standard PTA Balloon in the treatment of stenosis or occlusion of the femoropopliteal arteries.
16148862|NCT01790230|Device|LifeSeal™ Kit|Application of LifeSeal™ Kit for staple line reinforcement during open GI surgeries in Low Anterior Resection
16148863|NCT01790204|Dietary Supplement|Watercress Juice|The juice is prepared, by a trained member of the Chung laboratory staff, in the following manner; each serving of watercress juice will be prepared with 55gm watercress (from a local grocery store) with 220 ml purified water, for a proportion of 1:4 (w/w). The watercress and water will be placed in a 1.5 L mechanical blender and blended at low speed for approximately 15 seconds, followed by blending at a high speed for one additional minute. The resulting suspension will be filtered through two layers of cheese cloth. Remaining liquids will be manually extracted from the cheese cloth into the same container. Each serving will be measured to 200 ml. The remaining 20 ml will be used for analysis of ITC content. Each serving will be prepared and kept at 40 C until needed, no more than one hour prior to participant consumption by the subject.
16148864|NCT01790191|Behavioral|Repeated consumption of basic artichoke purée.|In this conditioning trial, the effect of repeated consumption of different types of artichoke purée was studied. In Arm 1, participants were repeatedly exposed to basic artichoke purée. In Arm 2, participants were repeatedly exposed to sweet artichoke purée. In Arm 3, participants were repeatedly exposed to fat artichoke purée. Change in intake and liking of basic artichoke purée was evaluated at baseline and after 10 exposures to artichoke purée ; and at 3 follow-ups: after 2 weeks (FU2W), after 3 months (FU3M) and after 6 months (FU6M).
16148865|NCT01790191|Behavioral|Repeated consumption of sweet artichoke purée.|In this conditioning trial, the effect of repeated consumption of different types of artichoke purée was studied. In Arm 1, participants were repeatedly exposed to basic artichoke purée. In Arm 2, participants were repeatedly exposed to sweet artichoke purée. In Arm 3, participants were repeatedly exposed to fat artichoke purée. Change in intake and liking of basic artichoke purée was evaluated at baseline and after 10 exposures to artichoke purée ; and at 3 follow-ups: after 2 weeks (FU2W), after 3 months (FU3M) and after 6 months (FU6M).
16148866|NCT01790191|Behavioral|Repeated exposure to fat artichoke purée.|In this conditioning trial, the effect of repeated consumption of different types of artichoke purée was studied. In Arm 1, participants were repeatedly exposed to basic artichoke purée. In Arm 2, participants were repeatedly exposed to sweet artichoke purée. In Arm 3, participants were repeatedly exposed to fat artichoke purée. Change in intake and liking of basic artichoke purée was evaluated at baseline and after 10 exposures to artichoke purée ; and at 3 follow-ups: after 2 weeks (FU2W), after 3 months (FU3M) and after 6 months (FU6M).
16148867|NCT01790178|Procedure|Ultrasound|The ultrasound guided group will have an ultrasound to identify the optimal site for biopsy and guide the procedure for safety purposes.
16148868|NCT01790165|Drug|TDT067 and Lamisil|Topical administration of TDT067 and single oral administration of 250 mg Lamisil tablet
16148869|NCT01790152|Other|Assessment of Therapy Complications|Ancillary studies
16148870|NCT01790152|Other|Laboratory Biomarker Analysis|Correlative studies
16148871|NCT01790152|Other|Quality-of-Life Assessment|Ancillary studies
16148872|NCT01790152|Other|Questionnaire Administration|Ancillary studies
16148873|NCT01790139|Drug|Oral simethicone|10 mL of simethicone is administered as an agent to prevent colonic bubbles
16148874|NCT01790126|Drug|ARN-509|
16148875|NCT01790126|Drug|LHRH Agonist|
16148876|NCT01790113|Device|Univers™|Control
16148877|NCT01790113|Device|Eclipse™ Total Shoulder Replacement|Investigational
16148878|NCT01790100|Drug|VX-135|12 weeks of VX-135
16148879|NCT01790100|Drug|Ribavirin|12 weeks of ribavirin
16148886|NCT01790061|Procedure|Standardized FMT|Fecal microbiota transplantation by gastroscopy administration of fresh or frozen bacteria from healthy donor to the mid-gut or whole colon
16148887|NCT01790061|Drug|Traditional treatments|Medications
16148888|NCT01790048|Dietary Supplement|Whey permeate RUSF|"Each child will receive 75 kcal/kg/day (314 kJ/kg/day) of whey RUSF. A ration of sufficient for two weeks based on the subject's weight will be distributed at each visit. Children will be asked to return every two weeks for follow-up, where caretakers report on the child's clinical symptoms, anthropometric measurements are re-assessed, and additional supplementary food is distributed for those that remained wasted.
~Whey RUSF contains whey permeate, WPC 80 (contains at least 80% protein), peanut paste, sugar, soy oil, a customized micronutrient premix to account for the minerals in whey permeate, and an emulsifier."
16148889|NCT01790048|Dietary Supplement|Soy Protein RUSF|"Each child will receive 75 kcal/kg/day (314 kJ/kg/day) of soy RUSF. A ration of sufficient for two weeks based on the subject's weight will be distributed at each visit. Children will be asked to return every two weeks for follow-up, where caretakers report on the child's clinical symptoms, anthropometric measurements are re-assessed, and additional supplementary food is distributed for those that remained wasted.
~Soy RUSF contains extruded soy flour, peanut paste, sugar, soy oil, palm oil, a premix containing concentrated minerals and vitamins, an emulsifier and dicalcium phosphate or calcium carbonate (Roche, Mumbai, India). Soy RUSF has no protein from animal sources."
16148890|NCT01790035|Drug|LGG|
16148891|NCT01790035|Drug|Placebo|
16148892|NCT01790022|Drug|Methylprednisolone|
16148893|NCT01790009|Dietary Supplement|Flavanol rich drink|
16148894|NCT01790009|Drug|Acetaminophen|2x500 mg Acetaminophen
16148895|NCT01789996|Procedure|alternative six minute walk test|"Alternate instructions will be given Subjects will
~walk as fast as they can in 6 minutes
~walk as normally as they can in 6 minutes
~walk leisurely as they can in 6 minutes. Pts will serve as their own controls."
16148896|NCT01789996|Procedure|Standard six minute walk test|Subjects will walk as far as they can in 6 minutes
16148897|NCT01789983|Behavioral|Walk With Ease Program|"The primary activity required of study subjects is a 6-week self-directed (non-group) WWE walking program that study participants do at a place and time that is convenient for them. To start the intervention/program, we schedule a brief baseline meeting with study participants to discuss the program, provide the WWE workbook, secure printed informed consent, and complete various questionnaires. Study participants are also asked to maintain a daily walking diary that is provided to them.
~The WWE program includes a workbook with strengthening and stretching exercises, basic facts about arthritis and PA, and information on how to individualize the program."
16148898|NCT01789983|Other|Collect Blood, GA and Other Survey Tools|"Geriatric Assessment (GA) (Version 5)
~Functional Assessment of Cancer Therapy-General (FACT)
~Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue36
~Outcome Expectations for Exercise (OEE) scale29
~Self-Efficacy to Manage Arthritis or Joint Pain (ASE/Arthritis Self-Efficacy)
~Perceived Self-Efficacy for Fatigue Self-Management (PSEFSM)34,35
~Visual Analog Scales (VAS)
~Surveys included in study are listed above. Whole Blood Sample will be collected for p16 analysis."
16148899|NCT01789970|Drug|Hydrocodone ER|"During the open-label, titration period, all participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours to identify a dosage deemed successful for managing their pain.
~Hydrocodone ER was taken by participants randomized to the hydrocodone ER treatment arm during the double-blind treatment period at the dose level identified during the titration period.
~Participants were instructed to take tablets with a glass of water on an empty stomach at least 1 hour before or 2 hours after eating."
16148900|NCT01789970|Drug|Placebo|"Placebo matching the active drug dose identified during the titration period was taken by participants randomized to the placebo treatment arm during the double-blind treatment period.
~Participants were instructed to take intervention with a glass of water on an empty stomach at least 1 hour before or 2 hours after eating."
16148901|NCT01789957|Drug|AC2993|4-Week transition of AC2993 5 mcg subcutaneously injected twice daily followed by an open-ended period through study termination (up to 52 weeks) of AC2993 10 mcg subcutaneously injected twice daily
16148902|NCT01789944|Behavioral|Behavioral: Family-based behavioral intervention|This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change
16148903|NCT01789931|Device|"Lifebeam"|"The lifebeam sensor will be attached to the participant's skin during the HTT."
16148904|NCT01789918|Device|PARADISE percutaneous renal denervation|Intravascular ultrasound emission
16148905|NCT01789905|Drug|Tigecycline (Tygacil)|Tigecycline 50 mg intravenously. Therapy conducted according to Japanese LPD of Tygacil. Tygacil will be dosed according to labeling. The administration and duration of the therapy will be determined by the treating physician to meet the patient individual needs for treatment.
16148906|NCT01789892|Drug|methylprednisolone|Given IV
16148907|NCT01789892|Radiation|fludeoxyglucose F 18|Undergo FDG PET/CT scan
16148908|NCT01789892|Procedure|positron emission tomography|Undergo FDG PET/CT scan
16148909|NCT01789892|Procedure|computed tomography|Undergo FDG PET/CT scan
16148910|NCT01789879|Drug|Levonorgestrel|Levonorgestrel 2-rod subdermal implant (75mg/rod) placed on study day 0 after baseline evaluations and remains in place until the subject requests removal or for the duration of drug activity (currently approved for 5 years).
16148911|NCT01789879|Drug|Nevirapine|Nevirapine 200mg twice daily as part of a complete antiretroviral therapy regimen. Subjects will be on this therapy prior to entry in this study.
16148912|NCT01789879|Drug|Efavirenz|Efavirenz 600mg once daily as part of a complete antiretroviral therapy regimen. Subjects will be on this therapy prior to entry in this study.
16148913|NCT01789853|Behavioral|Intensive Walking|8 weeks high intensity walking training over multiple stepping tasks
16148914|NCT01789853|Behavioral|Conventional Physical Therapy|Regular physical therapy for 8 weeks
16148915|NCT01789840|Device|Embosphere Microspheres|
16148916|NCT01789840|Procedure|TURP|
16148917|NCT01789827|Other|Laboratory Biomarker Analysis|Correlative studies
16148918|NCT01789827|Procedure|Radionuclide Imaging|Undergo technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2 scintigraphies
16148919|NCT01789827|Biological|Technetium Tc 99 Hydrazinonicotinamide-Tricine-linked Interleukin-2|Undergo technetium Tc 99 hydrazinonicotinamide-tricine-linked interleukin-2 scintigraphies
16148920|NCT01789814|Drug|Prasugrel|Patients will be randomized to prasugrel or clopidogrel to assess the effect of these drugs on inhibition of platelet aggregation following the cessation of bivalirudin therapy.
16148921|NCT01789814|Drug|Clopidogrel|Clopidogrel 600 mg as a loading dose immediately prior to the start of procedure and 75 mg daily thereafter
16148922|NCT01789801|Procedure|RAP palpation only|Skin disinfection by local antiseptic. Identification of the radial artery by palpation. Insertion of the needle positioned at 70 ° with regard to the artery palpated. Check the rise of arterial blood in the syringe.
16148923|NCT01789801|Procedure|RAP with ultrasound guidance|Skin disinfection by local antiseptic. Application of sterile gel. Identification of the artery via ultrasound vascular probe. Center the artery at the center of the screen. Introduction of the syringe at 70 ° with respect to the probe, in center of visualized zone. Check the rise of arterial blood in the syringe.
16148924|NCT01789788|Drug|Placebo|Matching placebo, multiple doses
16148925|NCT01789788|Drug|RO6811135|multiple ascending doses
16148926|NCT01789775|Drug|Drug: CD07805/47 gel|
16148927|NCT01789775|Drug|CD07805/47 gel Placebo|
16148928|NCT01789762|Biological|Autologous plasma|Transfusions of platelet concentrates re-suspended in autologous plasma
16148929|NCT01789762|Biological|Additive solution|Transfusions of platelets prepared in additive solution (Intersol)
16148930|NCT01789762|Biological|Pathogen reduction process|Patients transfused with platelets treated by pathogen reduction process
16148931|NCT01789749|Other|Snare Tip Soft Coagulation|
16148932|NCT01789749|Other|No Snare Tip Soft Coagulation|
16148933|NCT01789736|Drug|PG286 Ophthalmic Solution 0.5%|PG286 Ophthalmic Solution
16148934|NCT01789736|Drug|AR-12286 Ophthalmic Solution 0.5%|AR-12286 Ophthalmic Solution 0.5%
16148935|NCT01789736|Drug|Travoprost Ophthalmic Solution 0.004%|Travoprost Ophthalmic Solution 0.004%
16148936|NCT01789723|Drug|Fusilev|Fusilev will be administered by IV push (3-5 minutes) at a dose of 5 mg/m2. Fusilev administration, QID or BID will start 24 ± 3 hours after Folotyn administration depending on the dose cohort.
16148937|NCT01789723|Drug|Folotyn|A cycle of Folotyn treatment is 7 weeks, 6 weeks of treatment followed by 1 week of rest.
16148938|NCT01789710|Drug|Bupropion|All participants who are medically eligible to take Bupropion will receive this study medication one week prior to their smoking quit date.
16148939|NCT01789710|Drug|Nicotine replacement therapy|All participants will receive two forms of nicotine replacement therapy - nicotine patches and a rescue method (either gum or lozenge).
16148940|NCT01789710|Behavioral|Contingency Management|All participants will be asked to provide home carbon monoxide monitoring with equipment that is loaned to them. When participants provide readings that are low enough to suggest abstinence from smoking, they are provided monetary reinforcement (i.e., money).
16148941|NCT01789697|Other|cellular device/computers|A random group of patients will receive text messages to their cellular device from the surgeon, as well as emails to their email addresses.
16148942|NCT01789684|Other|Active Provider Intervention|Participating Sites assigned to the active intervention cluster will receive a multi-faceted provider education and decision support intervention to improve appropriate referral of breast cancer patients at risk for HBOC to genetic counseling and pre-surgical referral among newly diagnosed patients.
16148943|NCT01789671|Behavioral|Family-based behavioral intervention|This behavioral treatment includes behavioral skills training and accountability, including food and activity self-monitoring, goal setting, and home environment change.
16148944|NCT01789658|Other|Cryotherapy|Cryotherapy with ice-chips, ice cream or ice water is given during conditioning treatment with chemotherapy prior to HSCT.
16148945|NCT01789645|Other|Conservative group|The conservative group will received 3 treatment sessions of physical therapy based on neuromodulation of nociceptive processing of 30 minutes of duration, once per week.
16148946|NCT01789645|Procedure|Surgical group|The surgical group will receive the surgical procedure consisting of the decompression and release of the median nerve at the carpal tunnel performed by an experienced surgeon according to standardized protocols.
16148947|NCT01789619|Drug|Extended release tacrolimus (Advagraf®)|
16148948|NCT01789606|Drug|Ibuprofen 600 mg Immediate Release/Extended Release Caplet|Ibuprofen 600 mg Immediate Release/Extended Release Caplet to be adminstered orally (i.e., one caplet every 12 hours, not to exceed 2 caplets per day) for pain.
16148949|NCT01789593|Other|glucose clamp|Each subject will be randomly allocated to an experimental visit sequence consisting of a hypoglycaemic glucose clamp followed by euglycaemic glucose clamp (using i.v. infusion of human soluble insulin (Actrapid®)) or vice versa separated by at least 21 days. Each visit includes an overnight stay. For each of the two conditions (euglycaemia and hypoglycaemia) cognitive performance will be assessed by a validated cognitive test
16148950|NCT01789580|Other|Gambling moderator|
16148951|NCT01789567|Device|Engager™ aortic valve|Implantation of the Medtronic Engager™ bioprosthesis via direct aortic approach
16148952|NCT01789554|Other|MLS dispatch for bystander CPR|
16148953|NCT01789528|Drug|CAZ-AVI|IV infusion
16148954|NCT01789528|Drug|CXL|IV infusion
16148955|NCT01789502|Device|Fully covered metal stents|Fully covered metal stents were inserted by ERCP
16148956|NCT01789502|Device|Plastic stents|Plastic stents were inserted by ERCP
16148957|NCT01789489|Device|Medison Accuvix V20, sonde 3D5-9EK (Endovaginal 3 dimensional echography)|
16148958|NCT01789476|Drug|CR845|CR845 dosage = 0.005 mg/kg per dose, IV bolus. The initial dose was administered upon reaching a qualifying pain intensity score and followed by a supplemental dose, if requested by patient for pain. Additional doses could be administered every 8 hours up to 48 hours.
16148959|NCT01789476|Drug|Placebo|Matching placebo administered using same dosing algorithm as the active arm
16148960|NCT01789463|Other|Self rehabilitation|
16148961|NCT01789463|Other|Self rehabilitation plus physiotherapy|
16148962|NCT01789450|Procedure|Section of Periareolar Dermis in Breast Reduction.|
16148963|NCT01789437|Device|Dexamethasone Intravitreal Implant (Ozuredex)|
16148964|NCT01789411|Other|Drawing blood samples|Drawing blood samples from the arterial sheath prior to the standard coronary angiography procedure
16148965|NCT01789411|Device|Coronary intravascular ultrasound imaging|Coronary intravascular ultrasound imaging of a non-culprit coronary artery.
16148966|NCT01789411|Device|Coronary near-infrared spectroscopy|Near-infrared spectroscopy imaging of a non-culprit coronary artery (in patient who are included in the AtheroRemo-NIRS substudy).
16148967|NCT01789398|Drug|BF2.649|BF2.649 is provided in capsules. Patients should take 1 capsules per day with a glass of water. They will be instructed to take 1 capsule in the morning (after waking up, before breakfast).
16148968|NCT01789385|Drug|Dexmedetomidine|Starting with a 1 mg kg-1min-1 loading dose and than continued with a0.2-0.8 mg kg-1h-1 infusion rate.
16148969|NCT01789359|Other|Blueberry Juice|Dietary intervention
16148970|NCT01789346|Device|532nm potassium titanyl phosphate (KTP) laser|
16148971|NCT01789346|Device|595nm pulsed-dye laser (PDL)|
16148972|NCT01789333|Device|UVA Light with irradiance exposure of 9 mW/cm2|"The device's light emitting diode (LED) is used to deliver a metered dose of Ultraviolet A (UVA) light to a targeted treatment area for illuminating the cornea during corneal collagen cross-linking.
~The aperture setting will be set at 10 mm, and the eye will be irradiated for 10 minutes for the high irradiance exposure of 9 milliwatts (mW)/cm2. During the exposure, instillation of riboflavin will continue (1 drop every 3 minutes)."
16148973|NCT01789333|Drug|Riboflavin 0.1% ophthalmic solution|"The speculum is removed and one (1) drop of Riboflavin 0.1% ophthalmic solution will be instilled topically in the eye every 3 minutes for 30 minutes. At the end of the 30 minute riboflavin pre-treatment period, the eye will be examined to assure the presence of a yellow flare in the anterior chamber, indicating riboflavin saturation of the corneal tissue. If the yellow flare is not detected, riboflavin will continue to be instilled until the presence of the yellow flare in the anterior chamber is confirmed.
~During UVA irradiation, instillation of riboflavin will be continued every 3 minutes. For a 30-minute pre-treatment and 30-minute irradiation, the total dose of riboflavin solution is approximately 32 drops, or 1.6 ml (1 drop = 0.05 ml; 1.6 mL = 1.6 mg riboflavin)."
16148974|NCT01789320|Drug|triamcinolone acetonide (Triesence®)|4 mg of TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) administered as a single injection to the suprachoroidal space
16148975|NCT01789307|Dietary Supplement|corn syrup solids|oral ingestion 50 grams, 2 doses
16148976|NCT01789307|Dietary Supplement|sucrose|oral ingestion 50 grams, 2 doses
16148977|NCT01789294|Drug|Mesalamine|A standard 50 mg/kg/die daily dose of oral mesalamine was prescribed by Pediatric Gastroenterologists, which informed parents of potential side effects. Whether the drug was not well tolerated, patients were drop out. Treatment was discontinued at time 1 to look for symptom recurrence.
16148978|NCT01789294|Behavioral|DIET|Dietetic avoidance of cow's milk and egg, plus foods eventually detected by skin tests, was prescribed by Pediatric Allergologists. To ensure the correct adherence to diet with no nutritional impairment, a scheme of admitted foods and an appropriate calcium supplement dose were given to patients.
16148979|NCT01789281|Drug|Everolimus|Everolimus was provided by the investigator in 2.5 mg, 5 mg or 10 mg tablets for daily oral administration. The starting dose of everolimus was the same as the last dose that was given in the parent study. Dose modification thereafter was done at the discretion of the Investigator based upon what is in the subject's best interest.
16148980|NCT01789281|Drug|Sandostatin LAR Depot|Sandostatin LAR Depot was provided by Novartis or by the investigational site considering local regulations. The dose and frequency of Sandostatin LAR Intramuscular injections was the same as the last dose that was given in the parent study.
16148981|NCT01789268|Device|Respiratory Inductive Plethysmography|Respiratory Inductive Plethysmography (RIP) will be used to document thoracoabdominal motion, relative minute ventilation, and apnea during the minimally invasive respiratory assessments (NIRAs). Both Full and Preterm Infants will undergo a respiratory assessment via RIP prior to and after a bronchodilator (albuterol)
16148982|NCT01789255|Drug|vorinostat|Given PO
16148983|NCT01789255|Drug|tacrolimus|Given IV or PO
16148984|NCT01789255|Drug|cyclosporine|Given IV or PO
16148985|NCT01789255|Drug|methotrexate|Given IV
16148986|NCT01789255|Other|laboratory biomarker analysis|Correlative studies
16148987|NCT01789255|Other|pharmacological study|Correlative studies
16148988|NCT01789242|Drug|Carfilzomib|IV over 30 minutes on Days 1, 2, 8, 9, 15, and 16 every 28 days.
16148989|NCT01789242|Drug|Dexamethasone|Dexamethasone IV or PO on Days 1, 2, 8, 9, 15, and 16 every 28 days in patients with <VGPR after 4 cycles.
16148990|NCT01789229|Other|Tumor tissue collection|"Tissue sample is collected during therapeutic intervention by a medical doctor/surgeon.
~Frozen tissue sections are first transferred to Dept.of Pathology. Pathologist samples required tissue to obtain enough evidence for analysis/diagnosis.
~Rest tumor material with or without malignant cells is tranferred to the lab for Molecular Oncology of Prof.Zeillinger."
16148991|NCT01789229|Other|Sampling of ascites and pleural effusion|Samples of malignant ascites and/or malignant pleural effusion is only collected during therapeutic intervention from patients at inpatient care.
16148992|NCT01789229|Other|Collecting urine samples|Patient is asked to give a urine sample. Urine is collected in urine beaker.
16148993|NCT01789229|Other|Collecting saliva sample|Saliva sample is collected by spatula from the mouth cavity of the patient.
16148994|NCT01789229|Other|Collecting sputum|Patient is asked to produce sputum into a 50ml lab tube.
16148995|NCT01789229|Other|Collecting stool samples|Stool samples are collected prior to bowel preparation for colonoscopy. Device for sampling is provided to the patient.
16148996|NCT01789229|Other|Lavage/Irrigation|Irrigation liquid is collected during routine therapeutic or diagnostic procedure, e.g. lavage of the uterine cavity and fallopian tubes of women scheduled for surgery.
16148997|NCT01789216|Drug|NSAID|
16148998|NCT01789216|Drug|Gabapentinoids|
16148999|NCT01789216|Drug|placebo|
16149000|NCT01789203|Drug|Ciprofloxacin|Patients will be randomized 2:1 active comparator, Cipro, to placebo comparator.
16149001|NCT01789203|Drug|placebo|Patients will be randomized 2:1 placebo comparator to active comparator, Cipro.
16149002|NCT01789177|Device|Incentive Spirometry|Patients will be provided with plastic, disposable incentive spirometers postoperatively
16149003|NCT01789177|Other|Postoperative chest physiotherapy|Patients will be given routine postoperative chest physiotherapy instruction by nursing staff
16149004|NCT01789151|Device|Technetium labelled glucosamine|Nuclear medicine imaging of arthritic joints using radioactive glucosamine
16149070|NCT01788566|Drug|Cisplatin|Administered IV
16149005|NCT01789138|Behavioral|Situated Optimal Adherence Intervention|Situated Optimal Adherence Intervention consists of 3 individual sessions (during consecutive medication pick-up visits to the clinic) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using the Next Step Counseling approach. The intervention targets: accurate information about ART (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; promotion of perceived sense of ease and efficacy in working the ART regimen into the context of one's daily life and circumstances that may challenge drug use persistence; identification and refinement of skills that promote ease of adhering to one's ART regimen across the diverse and challenging contexts.
16149006|NCT01789125|Drug|Nicotine Patch|
16149007|NCT01789125|Behavioral|Smoking Termination and Anxiety Reduction Treatment|Integrated smoking cessation and anxiety reduction treatment
16149008|NCT01789125|Behavioral|Education-Supportive Psychotherapy|
16149009|NCT01789112|Other|Blood sample|Taking of blood sample
16149010|NCT01789099|Biological|UV1 synthetic peptide vaccine and GM-CSF|
16149011|NCT01789086|Drug|liraglutide|Administered subcutaneously (s.c., under skin) for 5-6 weeks. Initial dose of 0.6 mg/day. The dose will be escalated by 0.6 mg/day in weekly steps to a maximum of 3.0 mg/day
16149012|NCT01789086|Drug|placebo|Administered subcutaneously (s.c., under skin) for 5-6 weeks. Initial dose of 0.6 mg/day. The dose will be escalated by 0.6 mg/day in weekly steps to a maximum of 3.0 mg/day
16149013|NCT01789073|Dietary Supplement|Oral Impact, Nestlé Health Science|Oral Impact from Nestlé Health Science. An enteral nutritional supplement high in protein and with added immune-enhancing nutrients: arginine, fish oil and nucleotides. The intervention arm receives Oral Impact in an individually estimated dosage according to a protein requirement of 1.5 g/kg bodyweight/day (subtracted their habitual protein intake). Each patient receives this dosage orally the last 7 days prior to surgery.
16149014|NCT01789060|Other|p-AKT immunohistochemical staining|p-AKT staining on the adequate paraffin-embedded biopsy specimen or unstained slides
16149015|NCT01789047|Drug|Topiramate|Topiramate as adjunct to amantadine
16149016|NCT01789047|Drug|Placebo|Placebo control
16149017|NCT01789047|Drug|Amantadine|Existing treatment for all participants
16149018|NCT01789021|Device|4 blood glucose monitoring systems|
16149019|NCT01789008|Other|Determination of Advanced Fibrosis in Alcoholic Liver Disease|
16149020|NCT01788982|Drug|Nintedanib|Nintedanib should be administered orally at a dose of 200 mg twice daily.
16149021|NCT01788982|Drug|Placebo|
16149022|NCT01788969|Drug|Lexapro|Agent + training vs Placebo + training
16149023|NCT01788969|Drug|Placebo|Agent + training vs Placebo + training
16149024|NCT01788956|Device|Mespere Venous Oximeter|Mespere Venous oximeter provides non-invasive measurement of the oxygenation of the venous blood.
16149025|NCT01788956|Device|Co-Oximeter|
16149026|NCT01788930|Device|CPAP|
16149027|NCT01788917|Dietary Supplement|linseed oil|10 ml linseed oil per day over 10 weeks (without control oil)
16149028|NCT01788878|Behavioral|Questionnaires|"A first series of questionnaires will be given by the investigator at patients before treatment (inclusion visit) and then the questionnaires will be given at the follow-up visits planned at 6 months, 12 months and 18 months.
~Medical data will be collected via the CRF."
16149029|NCT01788865|Device|cSEMS(Covered self-expandable dual-layered metal stent) implant|
16149030|NCT01788839|Behavioral|surveys|A survey including the Female Sexual Function Index (FSFI), the Modified Female Sexual Function Index (FSFI-M), the Modified Female Sexual Function Index Follow-Up (FSFI-M Follow-Up) the Sexual Activity Questionnaire (SAQ), the Female Sexual Distress Scale (FSDS-R), the Menopausal Symptom Check List (MSCL), Patient-reported Outcomes Measurement Information System Sexual Function Instrument (PROMIS-SF), Abbreviated Dyadic Adjustment Scale for Relationships (ADAS), Reproductive Health Survey-baseline (RHS-B). Reproductive Health Survey-followup and (RHS-F1)Reproductive Health Survey-followup (RHS-F2) will be conducted at the following intervals: baseline/before chemotherapy +/- 1 month, 3 months after baseline +/- 1 month, 6 months after baseline +/- 1 month, 1 year after baseline +/- 1 month, and at intervals during survivorship that include yearly for 5 years +/- 2 months.
16149031|NCT01788839|Other|Blood draw|Those patients receiving chemotherapy who consent to the optional blood draw will provide blood at baseline (before start of chemotherapy), 12 months after baseline (+/-1 month) and 24 months after baseline (+/-2 months). All patients in the subset of the premenopausal cohort receiving tamoxifen only will have required blood draws at baseline (before they begin taking tamoxifen), at 6 months post-baseline/start of tamoxifen (+/- 2 weeks), 12 months post-start of tamoxifen (+/-1 month) and 24 months post-start of tamoxifen (+/-2 months). We will ask these participants for blood draws on day 1, 2, 3 or 4 of their menses at baseline and 6 months post-baseline/start of tamoxifen and during months 1 through 5 post-baseline/start of tamoxifen.
16149032|NCT01788839|Device|Transvaginal ultrasounds|Transvaginal ultrasounds are used to determine the number of antral follicles in each ovary. They will be performed to evaluate both the number and size of antral follicles of premenopausal women on Tamoxifen as antral follicle count is a good predictor of ovarian reserve and response. All patients in the subset of the premenopausal cohort receiving tamoxifen only will also have required transvaginal ultrasounds at baseline (before they begin taking tamoxifen) and at 6 months post-start of tamoxifen (+/- 2 weeks).
16149033|NCT01788826|Procedure|Prophylactic mesh|Closure of midline laparotomy using a prophylactic mesh. The midline is closed with a running absorbable monofilament suture with a suture/wound length ratio 4:1. The material is a monofilament uncoated suture made of poly-4hiydroxybutirate (Monomax, B.Braun) USP 1. Then, a prefascial large-pore low-weight 5 cm wide polypropylene mesh (Optilene Mesh Elastic, B.Braun) is fixed covering the midline closure. The mesh is fixed in the prefascial plane with absorbable monofilament interrupted sutures, USP 2/0.
16149034|NCT01788826|Procedure|No prophylactic mesh closure|Closure of midline laparotomy without mesh. The laparotomy is closed with a running absorbable monofilament suture with a suture/wound length ratio 4:1. The material is a monofilament uncoated suture made of poly-4hiydroxybutirate (Monomax, B.Braun) USP 1.
16149035|NCT01788813|Drug|GSK2245035|Nasal spray solution, to be given intranasal, 80 ng/20 ng once weekly for 8 weeks
16149036|NCT01788813|Drug|Placebo|Nasal Spray Solution, to be given intranasal, once weekly for 8 weeks
16149037|NCT01788800|Behavioral|Cognitive Behavioural Therapy (CBT)|9 sessions of CBT including psychoeducation and interoceptive exposure
16149038|NCT01788787|Behavioral|Quitline-Delivered Proactive Telephone Counseling|Smokers who enroll in treatment receive standard counseling protocol offered by the Quitline. This includes up to five proactive telephone counseling calls, each designed to provide practical expert support to help smokers develop problem-solving and coping skills, secure social support, and design a plan for successful cessation and long-term abstinence.
16149039|NCT01788787|Behavioral|Follow-Up Phone Call|Six months after enrolling in treatment with the Texas Quitline, an MD Anderson research team member will contact patients to assess their smoking status via telephone.
16149040|NCT01788787|Behavioral|Smoking Cessation Training|Medical staff (i.e., medical assistants, licensed vocational nurses, registered nurse and physicians) receive initial face-to-face group training on how to ask patients about their smoking status, advise them to quit, and connect them with the Quitline. The specific content of the session will include information on quitting smoking, how to implement AAC, the effectiveness of telephone counseling for smoking cessation delivered via quitlines, and pharmacotherapies including nicotine replacement.
16149041|NCT01788787|Behavioral|Qualitative Interviews Concerning the Implementation of AAC|MD Anderson staff conduct individual in-depth interviews with administrative leadership as well as those medical staff who are authorized to enter patient information into the EMR and are trained in the Ask-Advise-Connect approach. All in-depth interviews will be recorded and transcribed.
16149042|NCT01788774|Drug|Risperidone ISM 50 mg|
16149043|NCT01788774|Drug|Risperidone ISM 75 mg|
16149044|NCT01788774|Drug|Risperidone ISM 100 mg|
16149045|NCT01788761|Dietary Supplement|Probiotic Supplemented Group|
16149046|NCT01788761|Dietary Supplement|Control Group|
16149047|NCT01788748|Device|bipolar radiofrequency and infrared|
16149048|NCT01788748|Device|fractional bipolar radiofrequency|
16149049|NCT01788722|Drug|Dienogest (Visanne, BAY86-5258)|Patients in daily life clinical practice treatment receiving Visanne (dienogest 2mg) according to indication on the label.
16149050|NCT01788709|Other|preparation cleaning solution|
16149051|NCT01788696|Radiation|Group A - Early Imaging|Total of 3 scans
16149052|NCT01788696|Radiation|Group B - Delayed Imaging|Total of 2 scans
16149053|NCT01788683|Procedure|Regenexx SD|stem cell treatment
16149054|NCT01788683|Other|Exercise Therapy|exercise therapy control
16149055|NCT01788670|Dietary Supplement|Ethanol|
16149056|NCT01788670|Other|Water|
16149057|NCT01788657|Behavioral|Standard internet-based cognitive behavior therapy|Introduction to CBT and depression, Behavioral activation, Cognitive restructuring, Improve sleep, Handeling anxiety, Relapse prevention
16149058|NCT01788657|Behavioral|Condensed internet-based cognitive behavior therapy|Introduction to CBT and depression, Behavioral activation, Cognitive restructuring, Improve sleep, Handeling anxiety, Relapse prevention
16149059|NCT01788631|Drug|Regadenoson|Regadenoson is an A2AR agonist that is a coronary vasodilator. It is chemically described as adenosine, 2-[4-[(methylamino)carbonyl]-1H-pyrazol-1-yl]-, monohydrate. Its molecular formula is C15H18N8O5. Regadenoson has an FDA indication for use in radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. It has lower affinity for non-A2A adenosine receptor subtypes thought to be associated with some of the adverse effects associated with non-selective adenosine receptor agonists, which increase extracellular adenosine by blocking its uptake into cells. The maximal plasma concentration of regadenoson is achieved within 1 to 4 minutes after injection and parallels the onset of the pharmacodynamic response. Its half-life is approximately 2 to 4 minutes.
16149060|NCT01788631|Drug|Placebo|This study uses 0.9% Normal Saline (NS) as placebo. This is a sterile sodium chloride solution usually used to replenish fluids and electrolytes. It contains no additives, and is a standard solution used as placebo in clinical trials where the study drug is administration intravenously. NS will be prepared by investigational pharmacy.
16149061|NCT01788618|Other|Cognitive exams|"Psychopathological assessment (T0 and T3):
~Scale of Spielberger
~The self-administered questionnaire CES-D
~Cognitive assessment(T0 and T3):
~- MMS, Grober and Buschke test, memory for numbers (WAIS IV) sequence of numbers and letters (WAIS IV), arithmetic (WAIS IV), Trail Making Test, verbal Fluence, D2, Code (WAIS IV)
~Quality of Life: FACT-G and FACT-An Fatigue Module (T0 and T3):
~Self-assessment FACT-COG (T0,every months until T3)"
16149062|NCT01788618|Other|standardized cognitive rehabilitation|Patients will achieve 9 standardized cognitive rehabilitation sessions with the RehaCom ® software (over 3 months), and a self-assessment of their monthly experienced cognitive functioning using the self-administered questionnaire FACT-Cog
16149063|NCT01788618|Other|Standardized home exercise|These patients will take part in 9 sessions standardized home exercise (over 3 months), and a self-assessment every month felt their cognitive functioning using the self-administered questionnaire FACT Cog
16149064|NCT01788618|Other|Follow up by phone|These patients receive follow-up by phone (9 telephone calls over a period of 3 months) standardized optics to know the evolution of the disorder and felt the same way as for the other groups, a monthly self-assessment the feeling of cognitive functioning using the self-administered questionnaire FACT-Cog
16149065|NCT01788605|Drug|ramosetron|
16149066|NCT01788579|Behavioral|Multi-media WINGS|This one-hour computerized multimedia IPV prevention service tool features the same activities as the comparison condition, but these core elements are translated into interactive tools and culturally tailored video vignettes designed to enhance learning and provide individualized feedback. Thus, the multimedia service tool acts as a roadmap for this service session, prompting participants through the IPV screening, providing psycho-educational content on IPV and how IPV may interact with their substance misuse, providing individualized feedback on their IPV risks based on the screening e, creating a safety plan, defining relationship safety goals and identifying IPV-related service needs, and generating a personal plan for accessing services and contacting agency representative.
16149067|NCT01788579|Behavioral|Caseworker Delivered WINGS|The content for the comparison service condition incorporates the core elements of best practices for IPV screening, safety planning and referrals recommended by the American Medical Association and previous service research. It also contains brief psycho-educational content on recognizing IPV and how IPV may contribute to drug use and recidivism drawn from previous interventions and demonstrated to have promising effects in reducing rates of both IPV and drug use.
16149068|NCT01788566|Drug|Necitumumab|Administered IV
16149069|NCT01788566|Drug|Gemcitabine|Administered IV
16149071|NCT01788540|Drug|Intralipid|IV infusion of intralipid 20% is administrated on the day of vaginal egg collection in a dose of 9 mg/ml total blood volume corresponding to intralipid 2 ml 20% diluted in 250 ml saline over 30-60 minutes.the intralipid infusion is then repeated within the 1st week of positive pregnancy test and every 2 weeks till end of first trimester
16149072|NCT01788527|Device|CGM|Real Time Continuous Glucose Monitoring
16149073|NCT01788514|Other|Videogame|Subject will play an interactive educational videogame that is designed to increase their knowledge on influenza and the influenza vaccination.
16149074|NCT01788501|Drug|Tacrolimus|D-1~D20: iv infusion, q24hr (first daily dose: 0.03mg/kg) D20~D100: po q12hr (first daily dose: the quadruple of last iv dose) Dose modification according to TDM (10-20ng/ml)
16149075|NCT01788501|Drug|Cyclosporine|D-1~D20: iv infusion, q24hr (first daily dose: 3mg/kg) D20~D100: po q12hr (first daily dose: the 3 times of last iv dose) Dose modification according to TDM (200-300ng/ml)
16149076|NCT01788501|Drug|Methotrexate|D1: 15mg/m2 iv push D3,6,(11): 10mg/m2 iv push
16149077|NCT01788488|Other|Use of procalcitonin as biomarker to guide therapy|
16149078|NCT01788475|Drug|Dexamethasone|Ozurdex (dexamethasone) 0.7mg steroid implant
16149079|NCT01788462|Drug|Tesamorelin (Egrifta)|We will observe the effects of Tesamorelin on patients with HIV and lipodystrophy.
16149080|NCT01788436|Behavioral|Cognitive Test Battery 1|The Cognitive Test Battery 1 comprises the following tasks: Practice with graphics tablet, pen and screen; Digit Symbol Substitution Test (DSST); Implicit Pattern/Sequence Learning Task (PLT_Impl); Verbal Learning Test (VLT); Figure drawing; Mirror Drawing; Explicit Pattern Learning Task (PLT_Expl); Delayed Recall and Recognition Test; and Pursuit rotor.
16149081|NCT01788436|Behavioral|Cognitive Test Battery 2|The Cognitive Test Battery 2 comprises the following tasks: Practice with graphics tablet, pen and screen; Digit Symbol Substitution Test (DSST); Implicit Learning Retention Test; Hopkins Verbal Learning Test (HVLT); Figure drawing; Mirror Drawing; Explicit Learning Retention Test; Instrumental Learning Task; Pursuit rotor; and Sensory Motor Interception Adaptation Task.
16149082|NCT01788423|Device|hearing aid|All subjects received hearing aids, some selected by audiologist, some selected by consumer, and some programmed as placebo devices.
16149083|NCT01788410|Procedure|Cryoablation under image guidance|Observing efficacy of cryoablation to nerves and facet joints for the treatment of radicular pain and pain resulting from facet joint disease.
16149084|NCT01788410|Device|MRI Seednet Cryotherapy System (Galil Medical)|Observing efficacy of cryoablation to nerves and facet joints for the treatment of radicular pain and pain resulting from facet joint disease.
16149085|NCT01788397|Behavioral|Physical activity|Swimming, physiotherapy, water therapy, alpine skiing, xc-skiing, hippotherapy, climbing, cycling, rowing
16149086|NCT01788384|Drug|Clindamycin Phosphate / Benzoyl Peroxide Gel|Dosage form: topical gel Dosage: One pea-sized amount will be applied onto six areas of the face (chin, left cheek, right cheek, nose, left forehead, right forehead), avoiding the eyes, lips and mucous membranes.
16149087|NCT01788384|Drug|Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%|Dosage form: topical gel Dosage: One pea-sized amount will be applied onto six areas of the face (chin, left cheek, right cheek, nose, left forehead, right forehead), avoiding the eyes, lips and mucous membranes.
16149088|NCT01788384|Drug|Placebo (Vehicle Gel)|Dosage form: topical gel Dosage: One pea-sized amount will be applied onto six areas of the face (chin, left cheek, right cheek, nose, left forehead, right forehead), avoiding the eyes, lips and mucous membranes.
16149089|NCT01788371|Drug|Telbivudine|About 300 mothers with no treatment observedfrom 28 weeks of pregnancy to the week 4 of postpartun
16149090|NCT01788371|Drug|Lamivudine|About 300 mothers treated with lamivudine or telbivudine from 28 weeks of pregancy to the week 4 of postpartum
16149091|NCT01788358|Drug|Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)|Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 30/8 mg, orally once daily
16149092|NCT01788358|Drug|Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)|Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 30/16 mg, orally once daily
16149093|NCT01788358|Drug|Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)|Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 60/16 mg, orally once daily
16149094|NCT01788358|Drug|Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)|Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 60/32 mg, orally once daily
16149095|NCT01788345|Other|non- invasive ventilation|non-invasive bi-level ventilation with IPAP and EPAP.
16149096|NCT01788332|Drug|Olaparib|Olaparib is a potent inhibitor of poly (ADP-ribose) polymerase enzyme (PARP), (molecular weight 434) that is being developed as a monotherapy as well as for combination with chemotherapy and other anti-cancer agents. Olaparib can lead to tumour regression in patients with DNA repair deficient NSCLC. Olaparib may also enhance the DNA damaging effects of chemotherapy.
16149097|NCT01788332|Other|Placebo|3 100mg tablets to be administered twice a day with approximately 240ml of water
16149098|NCT01788319|Procedure|lasertrabeculoplasty|
16149099|NCT01788306|Drug|OOPEN+BBCC|Take-home naloxone is offered as part of a behavioral prevention intervention to reduce the occurrence of future opioid overdose.
16149100|NCT01788293|Other|Intervention group|"Control group will receive per-operative fluid at the discretion of the anesthetist, whereas Intervention group will receive additional hydroxyethylstarch 6% (HES) bolus in order to minimize and maintain PVI below 14 %.
~This PVI cut-off value was chosen according to previous reports [Cannesson et al., 2008; Zimmermann et al., 2010].
~During the postoperative period, both groups were managed by intensivists (in the ICU) and clinicians (in the wards) not involved in the intraoperative management or in data collection. These individuals were not informed of patient allocation."
16149101|NCT01788280|Drug|Fluciclitite , PET imaging, and Bevacizumab|[18F] Fluciclatide and PET imaging in patients with glioblastoma multiforme (GBM) to be treated with Bevacizumab
16149102|NCT01788267|Other|scan examination HR-pQCT|
16149103|NCT01788254|Drug|Codeine|A single oral low dose of codeine 5 mg and midazolam 1 mg administered as drop, pravastatin 5 mg, talinolol 2.5 mg, and torsemide 0.25 mg provided in capsules will be given together at the same time point (cocktail).
16149104|NCT01788254|Drug|Midazolam|A single oral low dose of codeine 5 mg and midazolam 1 mg administered as drop, pravastatin 5 mg, talinolol 2.5 mg, and torsemide 0.25 mg provided in capsules will be given together at the same time point (cocktail).
16149148|NCT01787760|Device|Test Soft Contact Lens C|Test lenses to be worn in a daily wear modality
16149105|NCT01788254|Drug|pravastatin|A single oral low dose of codeine 5 mg and midazolam 1 mg administered as drop, pravastatin 5 mg, talinolol 2.5 mg, and torsemide 0.25 mg provided in capsules will be given together at the same time point (cocktail).
16149106|NCT01788254|Drug|Talinolol|A single oral low dose of codeine 5 mg and midazolam 1 mg administered as drop, pravastatin 5 mg, talinolol 2.5 mg, and torsemide 0.25 mg provided in capsules will be given together at the same time point (cocktail).
16149107|NCT01788254|Drug|torsemide|A single oral low dose of codeine 5 mg and midazolam 1 mg administered as drop, pravastatin 5 mg, talinolol 2.5 mg, and torsemide 0.25 mg provided in capsules will be given together at the same time point (cocktail).
16149108|NCT01788228|Biological|Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted (A/Indonesia)|2 doses administered intramuscularly (IM) in deltoid region of arm at the Day 0 and Day 21 visits.
16149109|NCT01788215|Drug|doxycycline|200mg/day in divided doses of 100mg twice daily
16149110|NCT01788215|Other|Sugar Pill|1 pill twice a day
16149111|NCT01788189|Drug|Lenalidomide|
16149112|NCT01788176|Drug|Zoledronic acid|One single dose of 5mg intravenous infusion of zoledronic acid (interventional group)
16149113|NCT01788176|Drug|Placebo|one single intravenous infusion of 100ml of saline.
16149114|NCT01788163|Genetic|EGFR mutation test|EGFR mutation being tested in tissue and blood
16149115|NCT01788150|Device|Coronary Stenting|
16149116|NCT01788137|Drug|chemotherapy (CHOP)|Treatment Arm A (CHOP): cyclophosphamide(C), 750mg/m2 for injection on day1; doxorubicin(H), 50 mg/m 2 for injection on day1; and Vincristine(O), 1.4 mg/ m2 for injection on day1, prednisone(P) 60 mg/m2 orally on days 1 to 5. The therapy was repeated every 21 days for a total of 6 cycles
16149117|NCT01788137|Drug|chemotherapy(c-ATT)|Treatment Arm B (c-ATT):Alternative 3 regimen to be used sequentially(CHOPB→IMVP-16→DHAP).The therapy was repeated every 21 days for a total of 6 cycles.
16149118|NCT01788111|Other|Low back exercises 1|Excentric / concentric extension type exercises
16149119|NCT01788111|Other|Low back exercise 2|Traditional low back training
16149120|NCT01788085|Device|Bravo pH monitoring procedure|Bravo pH monitoring procedure
16149121|NCT01788072|Drug|Intranasal Oxytocin|24 IU taken twice daily (BID), in the morning and at noon/early afternoon
16149122|NCT01788072|Drug|Placebo|24 IU taken twice daily (BID), in the morning and at noon/early afternoon
16149123|NCT01788059|Other|injection the mesenchymal stem cell in non union site|
16149124|NCT01788046|Drug|Etelcalcetide|Administered intravenously three times per week. The starting dose was 5 mg. The dose may have been increased at weeks 5, 9, 13, and 17 (4-week intervals) by 2.5 mg or 5 mg on the basis of the predialysis parathyroid hormone and corrected calcium concentrations obtained in the prior week. The minimum dose was 2.5 mg and the maximum dose was 15 mg.
16149125|NCT01788046|Drug|Placebo|Administered intravenously (IV) three times per week.
16149126|NCT01788033|Drug|XOMA 052|0.3 mg/kg XOMA 052. Beginning on Day 0, each subject will receive one subcutaneous (SC) injection of study drug every 4 weeks for 12 weeks, a total of four injections
16149127|NCT01788033|Drug|Placebo|0.3 mg/kg Placebo. Beginning on Day 0, each subject will receive one subcutaneous (SC) injection of study drug every 4 weeks for 12 weeks, a total of four injections
16149128|NCT01788020|Drug|Dexamethasone, Rituximab, Cyclophosphamide|
16149129|NCT01788020|Drug|Dexamethasone, Rituximab, Cyclophosphamide, Bortezomib|
16149130|NCT01788007|Drug|Imiquimod Topical Cream 3.75%|Imiquimod Topical Cream 3.75% (Taro Pharmaceutical Industries Ltd.) applied once daily for two 14 day treatment cycles separated by a 14 day no treatment period.
16149131|NCT01788007|Drug|Zyclara® (imiquimod) Topical Cream 3.75%|Zyclara® (imiquimod) Topical Cream 3.75% (Medicis Pharmaceutical Co.) applied once daily for two 14 day treatment cycles separated by a 14 day no treatment period.
16149132|NCT01788007|Drug|Vehicle Topical Cream|Vehicle Topical Cream (Taro Pharmaceutical Industries Ltd.) applied once daily for two 14 day treatment cycles separated by a 14 day no treatment period.
16149133|NCT01787994|Genetic|Autologous CD4+ T cells genetically modified with a retroviral vector expressing the MazF endoribonuclease gene (MazF-T), given via intravenous infusion.|
16149134|NCT01787955|Procedure|PPPD with Braun anastomosis|making communication between E-loop and A-loop (Braun anastomosis 30cm away from duodenojejunostomy, by using staple method) will be added to conventional PPPD.
16149135|NCT01787955|Procedure|conventional PPPD|
16149136|NCT01787942|Device|Tear Science LipiView|The LipiView is a non-invasive instrument that captures live, special and digital images of your tear film and measures its lipid content and quality. This is a standardized test that quantifies your lipid to help your eye doctor determine if you should undergo the LipiFlow procedure or other tear therapies that would treat your condition. In effect, the LipiView allows your eye doctor to visualize your tear films.
16149137|NCT01787929|Procedure|hemiarthroplasty for displaced femoral neck fractures|Hemiarthroplasty is a surgery for displaced femoral neck fractures
16149138|NCT01787916|Drug|Liraglutide|Liraglutide will be compared to placebo for 24 weeks in a cross-over design
16149139|NCT01787916|Drug|Placebos|placebo will be compared to liraglutide for 24 weeks in a cross-over design
16149140|NCT01787903|Device|Real-time continuous glucose monitor|Active Comparator: MiniMed Paradigm® Veo™-system Placebo Comparator: iPro™2 Continuous Glucose Monitor (masked)
16149141|NCT01787851|Drug|Triheptanoin oil|
16149142|NCT01787838|Other|Focused Health Education|"A two-phase quality improvement study was designed to modify staff and patient behaviors. The project incorporated evidence-based strategies of staff education, feedback and incentives for performance and patient education.
~The staff received monthly feedback on departmental immunization rates, and incentives for performance. A one-page patient education flyer, written at 3rd grade reading level, was added to encourage patients to inquire about it."
16149143|NCT01787825|Device|PillCam SB2 capsule|Capsule Endoscopy system
16149144|NCT01787825|Device|CapsoCam SV-1|Capsule endoscopy
16149145|NCT01787799|Device|SYNERGY|Synergy is a device/drug combination product composed of two components, a device (coronary stent system including a chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating.
16149146|NCT01787773|Device|Veniti Inferior Vena Cava Filter|
16149147|NCT01787760|Device|Test Soft Contact Lens B|Test lenses to be worn in daily wear modality
16149149|NCT01787760|Device|Active Comparator|Control spectacle lenses to be worn in a daily wear modality
16149150|NCT01787747|Drug|AVP-786 Dose 1|
16149151|NCT01787747|Drug|AVP-786 Dose 2|
16149152|NCT01787747|Drug|AVP-786 Dose 1/Q Dose 1|
16149153|NCT01787747|Drug|AVP-786 Dose 1/Q Dose 2|
16149154|NCT01787747|Drug|AVP-786 Dose 2/Q Dose 2|
16149155|NCT01787747|Drug|AVP-923|
16149156|NCT01787721|Procedure|Ankle manipulation|
16149157|NCT01787721|Other|Sham manipulation|
16149158|NCT01787708|Procedure|Red light|
16149159|NCT01787695|Procedure|UVA1|"Patients with a vitiligo patch larger than 25cm2 will be recruited. The target patch will be divided into two halves. One half will be shielded by foil and served as control while the other half will be exposed to UVA1.
~The dose of UVA1 will be 60 J/cm2, 5 times a week for 4 weeks. Patients that have no or less than 10% pigmentation change after 4 weeks will receive UVA1 130J/cm2, 5 times a week for another 4 weeks. The patients with more than 10% pigmentation change will receive UVA1 60 J/cm2, 5times a week for another 4weeks. This will be followed by assessments at 4, 8, and 12 weeks post treatment."
16149160|NCT01787682|Dietary Supplement|BOOST High Protein|
16149161|NCT01787669|Drug|Avastin (Bevacizumab)|Avastin (Bevacizumab) administered intravitreally
16149162|NCT01787669|Drug|Ozurdex (dexamethasone)|Ozurdex (dexamethasone) given intravitreally
16149163|NCT01787643|Other|Height-Adjustable Desk Intallation in Office|
16149164|NCT01787630|Device|Hyaluronic acid|Injection in connection with ultrasound
16149165|NCT01787617|Behavioral|Aerobic Plus Resistance Training Group|Participants randomized to this intervention will engage in both aerobic and resistance training in accordance with Physical Activity Guidelines for Americans, that is 150 minutes of aerobic training and 2 days of additional 20 minutes of resistance training. The aerobic training component will be completed on a treadmill and target training intensity will be self-selected at 65% to 85% of maximal aerobic capacity. Each resistance training session will consist of both upper and lower body exercises: 2 sets of 9 exercises with each set consisting of 10 repetitions.
16149166|NCT01787617|Behavioral|Control Group|Participants randomized into the control group will not be provided with memberships to any exercise facility, nor will they receive behavioral instruction on how to increase physical activity. They will receive information on living a healthy lifestyle. Such minimal interventions have not been shown to increase physical activity in participants. The participants in this group will undergo the baseline, 10 week, and 20 week testing.
16149167|NCT01787604|Procedure|Aortic Root Reimplantation Procedure|Modified Florida Sleeve.
16149168|NCT01787604|Procedure|Aortic Valve Reimplantation Procedure|David I
16149169|NCT01787591|Other|Fat-Free Milk|Fat-free milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
16149170|NCT01787591|Other|Low-Fat Milk|Low-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
16149171|NCT01787591|Other|Full-Fat Milk|Full-fat milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
16149172|NCT01787591|Other|Soy Milk|Soy milk ingestion with 15 mg deuterium-labeled alpha-tocopherol.
16149173|NCT01787578|Drug|Sobetirome|50 mcg or 100 mcg once-daily oral
16149174|NCT01787565|Other|painPREMIER cohort|Low back pain patients prospectively recruited during the study period and managed with painPREMIER.
16149175|NCT01787565|Other|Control cohort|A matched group of low back pain patients not managed with painPREMIER.
16149176|NCT01787552|Drug|LDE225|
16149177|NCT01787552|Drug|INC424|
16149178|NCT01787539|Drug|Postoperative Chemotherapy|"Postoperative chemotherapy with EOX regimen: Epirubicin with intravenous bolus at a dose of 50 mg/m2 an on day 1; Oxaliplatin with intravenous infusion during a 2-hour period at a dose of 130 mg/m2; Capecitabine administrated orally at a twice daily dose of 625 mg /m2 during 21 days. Treatment cycles will be repeated every 3 weeks.
~Postoperative chemotherapy will be administrated in patients with tumor regression grade 0, 1, 2 randomized to perioperative chemotherapy and will be initiated 6 to 12 weeks after surgery."
16149179|NCT01787526|Drug|ferric carboxymaltose|1 g intravenously per infusion
16149180|NCT01787526|Drug|oral iron|oral tablets of 100mg iron over 8 weeks, total dose 10g
16149181|NCT01787513|Other|CBM|CBM is an Internet-based intervention comprised of delivery of auditory scenarios taking place over 1 week.
16149182|NCT01787513|Other|iCBT|iCBT is a validated online CBT treatment program for depression delivered in 6 lessons over 10 weeks.
16149183|NCT01787500|Biological|Cetuximab|Given IV
16149184|NCT01787500|Drug|Irinotecan Hydrochloride|Given IV
16149185|NCT01787500|Other|Laboratory Biomarker Analysis|Correlative studies
16149186|NCT01787500|Other|Pharmacological Study|Correlative studies
16149187|NCT01787500|Drug|Vemurafenib|Given PO
16149188|NCT01787487|Drug|Azacitidine|Given SC or IV
16149189|NCT01787487|Other|Laboratory Biomarker Analysis|Correlative studies
16149190|NCT01787487|Drug|Ruxolitinib Phosphate|Given PO
16149191|NCT01787474|Drug|Cytarabine|Given IV
16149192|NCT01787474|Biological|Filgrastim|Given SC
16149193|NCT01787474|Biological|Filgrastim-sndz|Given SC
16149194|NCT01787474|Drug|Fludarabine Phosphate|Given IV
16149195|NCT01787474|Other|Laboratory Biomarker Analysis|Correlative studies
16149196|NCT01787474|Biological|Membrane-bound Interleukin-21-Expanded Haploidentical Natural Killer Cells|Given IV
16149197|NCT01787461|Dietary Supplement|Imedeen|Two tablets per day for 6 months
16149198|NCT01787461|Dietary Supplement|Placebo|Two tablets per day for 6 months
16149199|NCT01787448|Drug|Topical gel vehicle|0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application
16149200|NCT01787448|Drug|Topical gel vehicle|0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application
16149201|NCT01787448|Drug|Sodium lauryl sulfate 0.1%|0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application
16149202|NCT01787448|Drug|Sodium chloride solution 0.9% (saline)|0.2 ml applied every 2 days (or 3 days if over the weekend) over 22 days (9 applications) followed by 10-14 day rest period and one subsequent re-application
16149868|NCT01782352|Dietary Supplement|Vitamin D3 placebo|
16149203|NCT01787435|Drug|Risk of asthma in offspring|"Exposure to PPI or H2RA, respectively during pregnancy
~No exposure to acid suppressing drugs during pregnancy"
16149204|NCT01787422|Other|Traditional versus Telemedicine office visit|
16149205|NCT01787409|Dietary Supplement|Cholecalciferol|Given PO
16149206|NCT01787409|Other|Laboratory Biomarker Analysis|Correlative studies
16149207|NCT01787396|Drug|Gemigliptin 50mg|
16149208|NCT01787396|Drug|Placebo(Metformin)|
16149209|NCT01787396|Drug|Metformin|
16149210|NCT01787396|Drug|Placebo(Gemigliptin)|
16149211|NCT01787383|Drug|Ingenol mebutate gel 0.05 %|Ingenol mebutate gel 0.05 % (Picato®) on trunk/extremities either applied simultaneously or sequentially
16149212|NCT01787383|Drug|Ingenol mebutate gel 0.015 %|Ingenol mebutate gel 0.015 % (Picato®) on face/scalp either applied simultaneously or sequentially
16149213|NCT01787357|Drug|Canagliflozin (JNJ-28431754)|One 300 mg dose of canagliflozin (JNJ-28431754) (comprising one 100 mg over-encapsulated tablet and one 200 mg over-encapsulated tablet) taken orally (by mouth) on Day 1 of Treatment A. One 1,200 mg dose of canagliflozin (comprising six 200 mg over-encapsulated tablets) taken orally on Day 1 of Treatment B.
16149214|NCT01787357|Drug|Placebo|Four over-encapsulated matching placebo tablets taken orally (by mouth) on Day 1 of Treatment A. Six over-encapsulated matching placebo tablets taken orally on Day 1 of Treatment C. Five encapsulated matching placebo tablets taken orally on Day 1 of Treatment D.
16149215|NCT01787357|Drug|Moxifloxacin|One 400 mg over-encapsulated tablet of moxifloxacin taken orally (by mouth) on Day 1 of Treatment D.
16149216|NCT01787344|Drug|Botulinum Toxin Type A(Botox®)|Single administration, 4units/kg body weight dose in patients with hemiplegia, 6units/kg body weight dose in patients with diplegia, Maximum dosage 200units
16149217|NCT01787344|Drug|Botulinum toxin type A(Botulax®)|Single administration, 4units/kg body weight dose in patients with hemiplegia,6units/kg body weight dose in patients with diplegia, Maximum dosage 200units
16149218|NCT01787331|Drug|Itraconazole|Given PO
16149219|NCT01787331|Other|Laboratory Biomarker Analysis|Correlative studies
16149220|NCT01787331|Other|Pharmacological Study|Correlative studies
16149221|NCT01787318|Device|ePID closed loop system|Insulin pump controlled by closed loop unit and algorithm
16149222|NCT01787318|Device|InsuPatch|device which applies local heating at 40 degrees Celsius to the vicinity of the subcutaneous insulin infusion insertion site
16149223|NCT01787292|Behavioral|Stretching Exercise Intervention|A. Light stretching and balance exercises under supervised trainer. 3 times per week for 20-45 minutes. HR will be targeted to be under 50% of age-related maximum.
16149224|NCT01787292|Behavioral|Aerobic Exercise Intervention|Supervised weekly exercise. 3 bouts of 45 minutes weekly on a cycle ergometer. HR will be kept at 75% of age-related maximum.
16149225|NCT01787292|Behavioral|Self Monitoring|6 month self-monitored training phase during which time participants will exercise according to prescribed regimen (cycling)
16149226|NCT01787279|Drug|Peginterferon alfa-2a [Pegasys]|180 mcg subcutaneously weekly, 48 weeks
16149227|NCT01787240|Drug|Escitalopram 10mg|
16149228|NCT01787240|Drug|Placebo|
16149229|NCT01787227|Device|xTAG RPP|
16149230|NCT01787214|Dietary Supplement|Full dose|20% of daily energy needs supplied by walnuts
16149231|NCT01787214|Dietary Supplement|Half dose|10% of daily energy needs supplied by walnuts
16149232|NCT01787214|Dietary Supplement|Control|Walnut free meals
16149233|NCT01787188|Drug|Meloxicam Test Capsules|
16149234|NCT01787188|Drug|Meloxicam Test Capsules|
16149235|NCT01787188|Drug|Placebo Capsules|
16149236|NCT01787175|Other|Integrated Medication Manager|A theory based electronic health record. Half of the provider participants were assigned the IMM to use. The other half were assigned the VA's CPRS EHR to use for the simulation. Providers were randomly assigned to a EHR to use.
16149237|NCT01787162|Other|Echocardiography, spiroergometry, cardiac catheterization|patients with CMPD will undergo echocardiography, spiroergometry, and right heart catheterization, if indicated
16149238|NCT01787149|Drug|DMARDs|
16149239|NCT01787136|Drug|Dextromethorphan|added on therapy
16149240|NCT01787123|Drug|Intravenous Cerebrolysin|14-day course of intravenous Cerebrolysin started within 4 days of ictus
16149241|NCT01787123|Drug|Normal Saline|14-day course of intravenous normal saline started within 4 days of ictus
16149242|NCT01787110|Drug|Oxygen|see arm description
16149243|NCT01787097|Drug|Symbicort® total dose 400ug/12ug|Symbicort® is combination of formoterol 400ug and budesonide 12ug. Single dose
16149244|NCT01787097|Drug|Symbicort® total dose 800ug/24ug|Symbicort® is combination of formoterol 800ug and budesonide 24ug. Single dose
16149245|NCT01787097|Drug|Formoterol 24ug|Turbuhaler
16149246|NCT01787097|Drug|BUD total dose 800ug|Turbuhaler
16149247|NCT01787084|Device|Edwards SAPIEN Transcatheter Heart Valve|Non-femoral transcatheter delivery of heart valve
16149248|NCT01787071|Other|Fluid challenge|Administration of red blood cell transfusions or fresh frozen plasma is not considered as a fluid challenge.
16149249|NCT01787058|Other|Dubai Cares beneficiary|Installation or rehabilitation of school water points, latrines and hygiene kits; promotion of good WASH practices and behavior change at school and within the community; establishment of management systems to ensure sustained WASH financing, monitoring and maintenance.
16149250|NCT01787045|Other|Early and Active Physical Therapy|"Cycle-ergometer exercise will be performed in the more active manner tolerated by patient. Potency attained will be registered during 30 min of exercise.
~Our physiotherapy protocol includes also others exercises like ambulation with assistance, cycle-ergometer for arms and legs, etc."
16149251|NCT01787045|Other|Passive Range of Motion|Passive mobilization will be performed in all limbs as 10 repetitions of every range of motions. Extension position will be maintained for some seconds to attaint muscular elongation in every muscular group.
16149252|NCT01787032|Drug|BI 113608|tablet
16149253|NCT01787032|Drug|BI 113608|tablet
16149254|NCT01787032|Drug|BI 113608|tablet
16149255|NCT01787032|Drug|Ketoconazole|tablet
16149256|NCT01787032|Drug|Voriconazole|tablet
16149257|NCT01787019|Other|Oral feeding|
16149258|NCT01787006|Drug|Cetuximab|Initial doses 400mg/m2 (day 1), followed by weekly doses of 250mg/m2 for 14 weeks in total
16149259|NCT01787006|Drug|Cisplatin, 5-FU|"5-FU: 1000mg/m2 per day as continuous infusion on day 1-4 of cycle 1 and 2, 750mg/m2/day as continuous infusion on day 1-4 of cycle 3 and 4
~Cisplatin 20mg/m2/day as intravenous bolus over 60 min on day 1-4 of every cycle"
16149260|NCT01787006|Radiation|Radiotherapy|59.4 Gy (33 fractions of 1.8 Gy) over 6.5-7 weeks (5 x 1.8 Gy per week)on primary tumor. 50.4 Gy on locoregional lymphnodes. If resectability is reached after 4-4.5 weeks (36-41.4 Gy) the radiotherapy stops after 45 Gy and the patient undergoes surgery.
16149261|NCT01786993|Device|MultiPoint Pacing|Subjects are programmed to MPP between 3 and 9 months. MPP programming is stipulated by the Echocardiographic measurements (e.g. EA VTI) during an acute hemodynamic assessment at the 3-month visit in the MPP IDE study.
16149262|NCT01786993|Device|Traditional Biventricular Pacing|Subjects are programmed to Quadripolar BiV pacing between 3 and 9 months using any of the 10 vectors available.
16149263|NCT01786967|Drug|Fesoterodine Fumarate|FDA approved anticholinergic medication used for treatment of urge urinary incontinence
16149264|NCT01786954|Device|Icare rebound tonometry|
16149265|NCT01786954|Device|Tonopen applanation|
16149266|NCT01786954|Device|Goldmann applanation|
16149267|NCT01786941|Other|Pre-Diabetes Group - 6-mo Aerobic and Resistance combined exercise training|
16149268|NCT01786941|Other|GBP Group - Non-diabetics intending to undergo Gastric Bypass surgery|
16149269|NCT01786928|Other|Resistance training|Resistance training group received training program for upper (shoulder flexion and abduction and biceps) and lower limbs (knee extension and flexion and hip flexion). Daily exercise for every muscle was performed with free weights at 80% of an maximal repetition test and a 4 minutes rest was allowed between each step.
16149270|NCT01786915|Drug|Bendavia 10mg|
16149271|NCT01786915|Drug|Bendavia 50mg|
16149272|NCT01786915|Drug|Placebo|
16149273|NCT01786902|Drug|DA-3002|
16149274|NCT01786889|Biological|blood and urine|Blood collection and urine collection after consent of the patient
16149275|NCT01786889|Behavioral|Questionnaire|The patient complete the questionnaire alone at home
16149276|NCT01786889|Behavioral|Telephone interview|The patient will be contacted by the CRA for a telephone interview of around one hour
16149277|NCT01786876|Drug|Radiolabeled SPD557|A single oral dose of 2 mg radiolabeled SPD557 administered on Day 1
16149278|NCT01786863|Procedure|Neuromuscular blockade|
16149279|NCT01786850|Procedure|Magnetic Resonance-guided High-intensity Focused Ultrasound (MRgFUS)|High intensity focused ultrasound (HIFU) is a non-invasive ablation technique under ultrasound (US) guidance for the treatment of solid tumors. Differently from other ablations, HIFU induces tissue necrosis through short (10-30s) and relatively low grade (60-80 C°) thermal stimulations. Clinical applications of HIFU include uterine fibroids, prostate, hepatic and breast cancer. Selected patients with pancreatic cancer have been treated with US-guided HIFU for both pain control and tumor debulking. The development of a MR guidance for HIFU (MRgFUS) enabled to perform real-time monitoring and precise control of beam direction, temperature changes and deposited thermal dose beyond the capability of conventional US guidance. This system has been approved for the treatment of uterine fibroids and bone metastases in the United States and European Union. As compared to conventional US-guided HIFU, MRgFUS could represent a more accurate ablation modality for unresectable pancreatic cancer.
16149280|NCT01786837|Device|Functional Magnetic Stimulation|20 minute stimulation will be applied 5 days a week for 5 weeks
16149281|NCT01786824|Drug|Hydration strategy using saline|For 12 hours preceding the coronarography, and for 12 following the coronarography, 0.9% sodium chloride at 1 ml/kg/h is administered via a slow intravenous perfusion.
16149282|NCT01786824|Drug|Hydration strategy using sodium bicarbonate|For 4-6 hours before the coronarography and for 4-6 hours after the coronarography, 500 ml of isotonic sodium bicarbonate solution (1.4%) will be administered via a slow intravenous solution.
16149283|NCT01786824|Drug|L-carnitine|"Before the coronarography (D-1), 1 gram of L-carnitine is administered via an oral solution that can be diluted in a small amount of sugar water if necessary. This administration corresponds to the beginning of a hydration protocol.
~For days 0 to 7 after the coronarography, patients are administered an oral L-carnitine solution (3 grams of L-carnitine per day). The latter may be diluted in a small amount of sugar water if needed."
16149284|NCT01786824|Procedure|Coronarography|All patients included in this study are programmed for a coronarography with injection of contrast material (either iodixanol or ioxaglate). The day of coronarography = Day 0.
16149285|NCT01786811|Behavioral|Training|"Initial Training: The training program for clinicians randomized into the intervention arm will be 2.5 hours. The project will be introduced and the Serious Illness Conversation Guide shared. The training session will include a brief didactic session on Challenges in discussing advance care planning/values and goals followed by practice using the SICG.
~Coaching and Feedback: We will also provide individual coaching for clinicians. Clinicians will be able to contact the study doctor to request coaching/debriefing on a challenging case; one of the investigators will respond within 24-48 hours for urgent or distressing cases (up to 72 hours on weekends). In-the-moment coaching will be by telephone or in person."
16149286|NCT01786798|Device|Transvaginal sonography|"Transvaginal sonography will be performed to:
~measure the endometrial thickness
~detect the endometrial pattern"
16149287|NCT01786772|Other|Cryotherapy and compression|Cryotherapy and intermittent pneumatic compression will be applied to the knee joint using a recirculating compression unit and knee sleeve. This unit will recirculate water which is between 1-3° C. Circumferential intermittent pneumatic compression to the knee joint (5 to 50 mm Hg) will be applied in conjunction with cryotherapy. The duration of intervention will be 20 minutes.
16149288|NCT01786772|Other|Cryotherapy|Cryotherapy will be applied to the knee joint using a recirculating compression unit and knee sleeve. This unit will recirculate water which is between 1-3° C. The duration of intervention will be 20 minutes.
16149289|NCT01786759|Drug|ClinOleic|the lipid of all-in-one, 0.5-3.5g/kg.d
16149290|NCT01786759|Drug|Intralipid|the lipid of all-in-one, 0.5-3.5g/kg.d
16149291|NCT01786746|Behavioral|cognitive behavioral therapy|cognitive behavioral therapy. 12 sessions.
16149292|NCT01786746|Behavioral|culturally adapted cognitive behavioral therapy|culturally adapted cognitive behavioral therapy for Chinese Americans. 12 sessions.
16149293|NCT01786733|Behavioral|Behavioral Activation|
16149294|NCT01786733|Behavioral|Supportive Therapy|
16149295|NCT01786707|Biological|Autologous stem cells|Pancreatic artery infusion of Autologous Stem cells.
16149296|NCT01786707|Other|Hyperbaric oxygen therapy|
16149297|NCT01786707|Drug|Insulin|Insulin dose as per clinical management
16149298|NCT01786707|Drug|Metformin|Metformin dose as tolerated
16149299|NCT01786694|Device|cma microdialysis catheter placement|the microdialysis catheters are sold by CMA
16149300|NCT01786681|Procedure|Positive pressure|
16149301|NCT01786668|Drug|Tofacitinib 2 mg|4 blinded tablets (two 1 mg tablets of tofacitinib along with two 5 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks
16149302|NCT01786668|Drug|Tofacitinib 5 mg|4 blinded tablets (one 5 mg tablet of tofacitinib, one 5 mg and two 1 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks
16149303|NCT01786668|Drug|Tofacitinib 10 mg|4 blinded tablets (two 5 mg tablets of tofacitinib and two 1 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks
16149304|NCT01786668|Drug|Placebo|4 blinded tablets (two 1 mg and two 5 mg matching placebo tablets) will be administered orally twice a day (in the AM and PM) for 12 weeks
16149305|NCT01786655|Drug|Neosaxitoxin in saline|NeoSTX will be administered in sequential dose cohorts. Each subject receives one injection with bupivacaine 0.2% alone on one side (control). On the other side they receive NeoSTX in saline (test). Subjects receive NeoSTX in saline in subsequent dose escalation levels: 5 mcg, 10 mcg, 15 mcg, 20 mcg, 30 mcg, and 40 mcg of NeoSTX.
16149306|NCT01786655|Drug|NeoSTX + bupivacaine 0.2%|NeoSTX will be administered in sequential dose cohorts. Each subject receives one injection with bupivacaine 0.2% on one side (control). On the other side they receive NeoSTX with 0.2% bupivacaine. Subjects receive NeoSTX in 0.2% bupivacaine in subsequent dose escalation levels: 5 mcg, 10 mcg, 15 mcg, 20 mcg, 30 mcg, and 40 mcg of NeoSTX.
16149307|NCT01786655|Drug|NeoSTX + bupivacaine 0.2% + epinephrine 5mcg/ml|Each subject receives one injection with bupivacaine 0.2% on one side (control). On the other side they receive NeoSTX in 0.2% bupivacaine with epinephrine 5 mcg/ml. Subjects receive NeoSTX in 0.2% bupivacaine with epinephrine 5 mcg/ml in doses of 10 mcg or 30 mcg of NeoSTX.
16149308|NCT01786655|Other|Saline placebo|Each subject receives one injection with bupivacaine 0.2% alone on one side. On the other side they receive saline placebo.
16149309|NCT01786629|Drug|SUPREP Bowel Prep Kit|solution for oral administration prior to colonoscopy
16149310|NCT01786629|Drug|FDA approved bowel preparation containing electrolytes|solution for oral administration prior to colonoscopy
16149311|NCT01786616|Drug|Formoterol|
16149312|NCT01786603|Drug|Rasagiline|Rasagiline 2mg once a day for 12 months.
16149313|NCT01786603|Drug|Placebo|Placebo (looks like study drug but has no active ingredients) once a day for 12 months.
16149314|NCT01786590|Procedure|EBUS-TBNA|Currently EBUS-TBNA is performed in patients with CT and/or PET positive lymph nodes in the mediastinum or hilum. In this study, all patients being considered for SBRT will undergo EBUS-TBNA for the lymph node staging prior to SBRT.
16149315|NCT01786577|Other|Magnetic Resonance Imaging|Both groups will undergo two MRIs at baseline and within 48 hours after surgery/non-surgery.
16149316|NCT01786577|Behavioral|Cognitive assessment testing|Both groups will undergo in-person baseline assessment of cognitive functioning as well as assessments at three weeks, three months and one year.
16149317|NCT01786551|Drug|Eplerenone|50 mg daily for 14 days
16149318|NCT01786538|Drug|Regorafenib/FOLFOX|FOLFOX consisted of oxaliplatin 85 mg/m2 on D1, leucovorin 400 mg/m2 on D1, 5-fluorouracil 400 mg/m2 intravenous bolus on D1 and 5-fluorouracil 1200 mg/m2/day continuous infusion on D1-2 (2400 mg/m2 for 46 hours). Regorafenib will be administered 160 mg/day given orally on D4-10 (7 days per each cycle of FOLFOX). Treatment will be repeated every 2 weeks and continued until disease progression, unacceptable toxicity or the patient's refusal.
16149319|NCT01786538|Drug|Placebo/FOLFOX|FOLFOX consisted of oxaliplatin 85 mg/m2 on D1, leucovorin 400 mg/m2 on D1, 5-fluorouracil 400 mg/m2 intravenous bolus on D1 and 5-fluorouracil 1200 mg/m2/day continuous infusion on D1-2 (2400 mg/m2 for 46 hours). Placebo will be administered 160 mg/day given orally on D4-10 (7 days per each cycle of FOLFOX). Treatment will be repeated every 2 weeks and continued until disease progression, unacceptable toxicity or the patient's refusal.
16149320|NCT01786525|Behavioral|House Calls|60-minute home based educational intervention which will be administered by a health educator
16149321|NCT01786525|Behavioral|Web-Based Patient-Centered Decision Support Intervention|Patients will be provided with access to the study website which will allow them to learn and receive LDKT support in a way the best meets their personal values and preferences
16149322|NCT01786512|Drug|Omecamtiv Mecarbil Matrix F1 Formulation|Modified release tablets for oral administration
16149323|NCT01786512|Drug|Omecamtiv Mecarbil Matrix F2 Formulation|Modified release tablets for oral administration
16149324|NCT01786512|Drug|Placebo|Modified release tablets matching to omecamtiv mecarbil
16149325|NCT01786512|Drug|Omecamtiv Mecarbil Swellable Core Technology F2|Modified release tablets for oral administration
16149326|NCT01786499|Behavioral|Relaxation Response Training|
16149327|NCT01786486|Device|Amplatzer Cardiac Plug|
16149328|NCT01786473|Drug|Testogel 1%|
16149329|NCT01786473|Drug|Placebo|
16149330|NCT01786460|Other|Blood draw at Days 0, 7, 14, and 21|
16149331|NCT01786434|Drug|Routine medication arm|50 micrograms of fentanyl given before the procedure
16149332|NCT01786434|Drug|Fentanyl on-demand arm|Fentanyl 50 microgram is provided on-demand, that is, if the patient has pain during the procedure.
16149333|NCT01786408|Device|TAP20-C|
16149334|NCT01786408|Device|SAFE-T-FILL CAPILLARY BLOOD COLLECTION SYSTEM|
16149335|NCT01786395|Drug|UF-021|
16149336|NCT01786395|Drug|Placebo|
16149337|NCT01786382|Drug|PPI-668|
16149338|NCT01786382|Drug|Midazolam|
16149339|NCT01786382|Drug|Omeprazole|
16149340|NCT01786382|Drug|Telaprevir|
16149341|NCT01786356|Device|HOYA iMics Y-60H|same-day bilateral cataract surgery with implantation of intraocular lens HOYA iMics Y-60H in one eye
16149342|NCT01786356|Other|B&L MI60|same-day bilateral cataract surgery with implantation of intraocular lens B&L MI60 in one eye
16149343|NCT01786343|Drug|Decitabine|20 mg/m2 by vein daily for either 5 or 10 days.
16149344|NCT01786330|Device|Procare abdominal binder|
16149345|NCT01786330|Other|Standard of Care|
16149346|NCT01786317|Device|High resolution manometry|Anorectal High resoltion manometry using electronic sensors
16149347|NCT01786304|Procedure|Sacral nerve stimulation|implantation of a stimulation electrode in one of the S2-S3-S4 sacral hole then connected to a subcutaneous stimulator for permanent stimulation of the sacral nerve
16149348|NCT01786278|Radiation|Brachytherapy|Single dose of 12 Gy generated using a flexible applicator containing Iridium 192 with the range of irradiation of 1cm from the applicator axis. The extent of irradiation will cover the whole length of cancer stricture and 2cm beyond proximal and distal end of the tumor.
16149349|NCT01786278|Procedure|Endoscopic stenting|Endoscopic stenting with partially covered selfexpandable metalic stents positioned across the cancer stricture and extending 2cm proximally and 2cm distally to the proximal and distal end of the tumor, respectively
16149350|NCT01786265|Drug|Abiraterone Acetate|Given PO
16149351|NCT01786265|Drug|Bicalutamide|Given PO
16149352|NCT01786265|Drug|Degarelix|Given via injection
16149353|NCT01786265|Drug|Flutamide|Given PO
16149354|NCT01786265|Drug|Goserelin Acetate|Given via injection
16149355|NCT01786265|Drug|Leuprolide Acetate|Given via injection
16149356|NCT01786265|Drug|Nilutamide|Given PO
16149357|NCT01786265|Drug|Prednisone|
16149358|NCT01786252|Drug|human chorionic gonadotropin (hCG)|"500IU of hCG diluted to a final volume of 50ul in IVF media (Global-trademark)"
16149359|NCT01786252|Drug|Placebo Comparator (for hCG)|"50ul of IVF medium (Global-trademark) to mimic hCG infusion"
16149360|NCT01786239|Drug|Risperidone|The dosage for risperidone will be 1 mg to 6 mg per day. The dose of the risperidone will be based on the participant's clinical improvement and side effects.
16149361|NCT01786239|Drug|Omega-3 capsules|The total daily dose for omega-3 subjects will be 740 mg of eicosapentanoic acid (EPA)and 400 mg of docosahexaenoic acid(DHA). This dose will start on day 1 and stay the same dose until study completion.
16149362|NCT01786239|Drug|Placebo|The total daily dose for subjects assigned to placebo will be 2000 mg. This dose will start on day 1 and stay the same dose until study completion.
16149363|NCT01786226|Drug|Oral administration of mifepristone 2.5 mg daily for three months|Experimental: 1
16149364|NCT01786226|Drug|Oral administration of mifepristone 5 mg daily for three months|Experimental: 2
16149365|NCT01786200|Drug|Aspirin|
16149366|NCT01786200|Drug|Ibuprofen|
16149367|NCT01786187|Behavioral|Light Physical Activity|Conventional treatment for cancer as prescribed by the participant's health care providers and will receive a home-based light physical activity program to help manage a specific symptom related to cancer and cancer treatment.
16149368|NCT01786187|Other|Symptom Experience Report|Conventional treatment for cancer as prescribed by the participant's health care providers and will receive planned, structured, weekly telephone visits to report the experience of symptoms and health-related quality of life information.
16149369|NCT01786174|Drug|Gilenya|0.5mg Gilenya orally by mouth once daily for approximately 28 days
16149370|NCT01786174|Other|Placebo|0.5mg placebo (sugar pill) orally by mouth once daily for approximately 28 days
16149371|NCT01786161|Drug|Vancomycin continuous infusion|Vancomycin 24 hour intravenous continuous infusion
16149372|NCT01786161|Drug|Vancomycin intermittent dosing interval|Vancomycin intravenous infusion at rate 1000mg/hr
16149373|NCT01786148|Behavioral|mobile phone application|
16149374|NCT01786135|Drug|SGN-CD19A|SGN-CD19A (IV) once every 21 days (3 weeks) or 42 days (6 weeks)
16149375|NCT01786122|Other|Supervised Physical activity|Both groups received standardized usual care. The EP group will receive, in addition, a nurse supervised exercise program for 2 months in the PHC and a second phase in community facilities during the remaining 10 month
16149376|NCT01786122|Behavioral|education program on healthy habits|education program on healthy habits for 2 months in the PHC and a second phase in community facilities during the remaining 10 months
16149377|NCT01786109|Drug|Dronabinol|Dronabinol is a synthetic delta-9-tetrahydrocannabinol, a nonselective cannabinoid agonist. Subjects received one dose of either 2.5 mg or 5 mg orally with water.
16149378|NCT01786109|Drug|Placebo|Placebo will match study drug; taken as one dose orally with water.
16149379|NCT01786096|Drug|SGN-CD19A|SGN-CD19A (IV) once (Day 1) or twice (Days 1 and 8) every 21 days; dose range: 0.3-6 mg/kg
16149380|NCT01786083|Behavioral|Application of Problem Solving Technique|
16149381|NCT01786070|Drug|Budesonide|
16149382|NCT01786070|Drug|placebo|
16149383|NCT01786057|Procedure|Extracorporeal shock wave therapy 1|Extracorporeal shock wave therapy , (3000 shock waves/session of 0.2 mJ/mm2) for heel region and (400 shock waves/session of 0.2 mJ/mm2 per each trigger point) for gastrosoleus trigger points , 3 sessions at weekly intervals
16149384|NCT01786057|Procedure|Extracorporeal shock wave therapy 2|Extracorporeal shock wave therapy , (3000 shock waves/session of 0.2 mJ/mm2) for heel region , 3 sessions at weekly intervals
16149385|NCT01786044|Behavioral|MasterMed|An online interactive educational program
16149386|NCT01786044|Behavioral|Usual Care|
16149387|NCT01786031|Other|metastasis biopsy|
16149388|NCT01786018|Drug|Thiotepa|
16149389|NCT01786018|Drug|Busulfan|
16149390|NCT01786018|Drug|Fludarabin|
16149391|NCT01786018|Procedure|transplant (HCT)|Transplant will be PBSCs collected as per institutional standard. A portion of the PBSC product will be removed for DLI that is equivalent to 3x10^7 CD3 cells/kg recipient weight and cryopreserved.
16149392|NCT01786018|Radiation|Cytoreduction|Cytoreduction and /or radiation therapy will be given by the referring physician or the attending physician as determined on clinical grounds or to meet eligibility requirements of the protocol for patients with advanced malignancy or to reduce tumor bulk. However, no intensive chemotherapy can be given within three weeks before conditioning.
16149393|NCT01786018|Drug|Immunosuppression|Day -3. Commence cyclosporine at 5.0 mg/kg PO Q12 hours, continue to day +50 and then taper by 5% per week until day +180.
16149394|NCT01786018|Drug|Cyclosporine|"CSP is given based on adjusted body weight, at 5.0 mg/kg PO q12 hours from day -3.
~If there is nausea and vomiting at anytime during CSP treatment the drug should be given intravenously at the appropriate dose that was used to obtain a therapeutic level.
~See guidelines for PO to IV conversion below."
16149395|NCT01786018|Drug|Methotrexate|Day 1 15 mg Days 3, 6, 11 10 mg m2 day IV for GVHD prevention
16149396|NCT01786018|Drug|ATG|(FOR UNRELATED TRANSPLANTS ONLY) Days -3, -2: 2.5 mg /kg/day
16149397|NCT01786018|Procedure|Collection and infusions of Donor PBSC|Collection and infusions of Donor PBSC
16149398|NCT01786005|Device|Transcranial magnetic stimulation|
16149399|NCT01785992|Drug|Irosustat|Patients will receive 40mg of Irosustat once daily in addition to the aromatase inhibitor on which they progressed until disease progression or development of unacceptable toxicities.
16149400|NCT01785979|Drug|prednisone induction - chloroquine|At study entry, the patients will undergo physical examination and laboratory tests, including blood cell count, malaria microscopy, immune-chromatographic test for malaria antigen, malaria serology titers, and serum protein studies with immunoglobulin M quantification, immune-fixation and immunoglobulin free light chains measurement. We will assess all participants at 1, 3, 6 and 12 months after enrollment. Clinical examination and routine laboratory tests are done every 3 months during the follow-up period. Immunoglobulin M quantification and malaria serology are done at baseline, and at month 12 visit.
16149401|NCT01785979|Drug|Chloroquine|At study entry, the patients will undergo physical examination and laboratory tests, including blood cell count, malaria microscopy, immune-chromatographic test for malaria antigen, malaria serology titers, and serum protein studies with immunoglobulin M quantification, immune-fixation and immunoglobulin free light chains measurement. We will assess all participants at 1, 3, 6 and 12 months after enrollment. Clinical examination and routine laboratory tests are done every 3 months during the follow-up period. Immunoglobulin M quantification and malaria serology are done at baseline, and at month 12 visit.
16149402|NCT01785966|Behavioral|Daily checklist and clinician prompting|"Interventions are:
~Checklists: The checklists are arranged in a paper notebook (one per patient) with a daily list on each page, as most ICUs do not have electronic health record systems. During the multidisciplinary visit, the checklist items are read aloud by the nurse and answered by participants of the visit. The checklist is applied at least once on all week days preferably in the mornings, although we strongly suggest applying it also on weekend days.
~Daily Goals and Clinician Prompting: During the clinical discussion of each patient and the application of the checklist, the intensivists write down the daily goals in a standardized form and read them aloud to the team. Every afternoon between 3 and 5 PM, a nurse reviews the daily goals and takes note of any pending items. Subsequently, the nurse prompts the on-call physician, requesting solutions for these pending items."
16149403|NCT01785940|Procedure|Interscalene block|Interscalene catheters will be placed under aseptic precautions in each patient by one of the investigators using combined peripheral nerve stimulation and ultrasound guidance to get twitch in the C5-C6 dermatomes and documented spread of injectate near C5-6 nerve roots. Twenty mL of 0.2% ropivacaine will be injected while documenting adequate drug spread under ultrasound. After 20 min of injection, the interscalene nerve block will be evaluated and considered successful with inability to abduct the shoulder and a decrease in perceived sensation to cold of the skin over the deltoid muscle.
16149404|NCT01785927|Other|ABCD|Rifampicin, isoniazid, pyrazinamide, and levofloxacin dry powders will be administered to each patient by randomization. Each formulation will be assigned the code, such as A, B, C, or D, and the treatment sequences will be generated as ABCD (sequence 1), BCDA (sequence 2), CDAB (sequence 3) and DABC (sequence 4). On the first day of drug dosing in period I, volunteers will be randomly assigned to a sequence of treatments as indicated in a pre-printed randomization scheme, which was generated using block randomization with block sizes of 4 and 6, and the allocation ratio of 1:1. Subjects will be stratified by sex. Subjects in sequence 1 will receive treatment A during the first study period and will then cross over to receive treatment B, C, and D at the second, third and fourth periods, respectively (each after a 7-day washout period).
16149405|NCT01785901|Other|without interventions|without interventions
16149406|NCT01785875|Drug|Etelcalcetide|Administered by bolus injection into the venous line of the dialysis circuit at the end of hemodialysis treatment, and prior to or during rinse-back with each hemodialysis session (ie, 3 times per week).
16149407|NCT01785862|Drug|Ibuprofen 25 mg|Lozenge, Oromucosal administration
16149408|NCT01785862|Drug|Placebo|Lozenge matching V0498 lozenge, Oromucosal administration
16149409|NCT01785849|Drug|Etelcalcetide|Administered intravenously three times per week. The starting dose was 5 mg. The dose may have been increased at 4-week intervals by 2.5 mg or 5 mg on the basis of the predialysis parathyroid hormone and corrected calcium concentrations obtained in the prior week. The minimum dose was 2.5 mg and the maximum dose was 15 mg.
16149410|NCT01785849|Drug|Placebo|Administered intravenously (IV) three times per week.
16149411|NCT01785836|Drug|Dapsone Formulation A|Dapsone Formulation A applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
16149412|NCT01785836|Drug|Dapsone Formulation B|Dapsone Formulation B applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
16149413|NCT01785836|Drug|Dapsone Formulation C|Dapsone Formulation C applied once daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
16149414|NCT01785836|Drug|Dapsone 5% Gel|Dapsone 5% gel (ACZONE®) applied twice daily to the face and upper chest, upper back, and shoulders (as per protocol) for 12 weeks.
16149415|NCT01785823|Other|FX2-2-2|Their background infusions of fentanyl diluent (2 ml/hr of diluent was equivalent with 0.5 μg/kg/hr of fentanyl) were maintained at the fixed-rate of 2 ml/hr until the postoperative 24 hr (FX2-2-2), or at the decremental rates of 6.0 ml/hr (D6-4-2) and 8.0 ml/hr (D8-4-2) during 1 hr, 4.0 ml/hr during 1~3 hr and 2.0 ml/hr during 3~24 hr, postoperatively. The visual analogue scores (VAS), the incidence of inadequate analgesia, the frequency of intervention of PCA, and side effects were evaluated.
16149416|NCT01785823|Other|D6-4-2|Their background infusions of fentanyl diluent (2 ml/hr of diluent was equivalent with 0.5 μg/kg/hr of fentanyl) were maintained at the fixed-rate of 2 ml/hr until the postoperative 24 hr (FX2-2-2), or at the decremental rates of 6.0 ml/hr (D6-4-2) and 8.0 ml/hr (D8-4-2) during 1 hr, 4.0 ml/hr during 1~3 hr and 2.0 ml/hr during 3~24 hr, postoperatively. The visual analogue scores (VAS), the incidence of inadequate analgesia, the frequency of intervention of PCA, and side effects were evaluated.
16149417|NCT01785823|Other|D8-4-2|Their background infusions of fentanyl diluent (2 ml/hr of diluent was equivalent with 0.5 μg/kg/hr of fentanyl) were maintained at the fixed-rate of 2 ml/hr until the postoperative 24 hr (FX2-2-2), or at the decremental rates of 6.0 ml/hr (D6-4-2) and 8.0 ml/hr (D8-4-2) during 1 hr, 4.0 ml/hr during 1~3 hr and 2.0 ml/hr during 3~24 hr, postoperatively. The visual analogue scores (VAS), the incidence of inadequate analgesia, the frequency of intervention of PCA, and side effects were evaluated.
16149418|NCT01785810|Drug|Maraviroc 300 mg|Patients enrolled on this trial will receive a standard conditioning regimen with fludarabine and busulfan followed by a peripheral blood stem cell infusion from an unrelated donor, standard GVHD prophylaxis and standard antiviral and antifungal prophylaxis. In addition, all patients will receive maraviroc from day -3 to d+ 90.
16149419|NCT01785797|Device|Silicon subdural drain placement after burr hole evacuation of chronic subdural hematoma|
16149420|NCT01785784|Drug|rhGM-CSF Gel|
16149421|NCT01785771|Drug|ITCA 650 (exenatide in DUROS)|
16149422|NCT01785758|Drug|Sugammadex (4 mg/Kg)|Sugammadex administered at the end of surgical procedure, once skin suture had been finished, to reverse profound neuromuscular blockade induced and maintained with rocuronium
16149423|NCT01785745|Other|Neurocognitive therapeutic exercise|Ten exercises involving specific instruments (e.g., table inclined with a board with five concentric circles, sponges of various texture). One-hour session for three times a week for five weeks.
16149424|NCT01785745|Other|Traditional therapeutic exercise|Different exercises as strengthening exercises, stretching exercises, Codman's pendulum exercises and exercises against elastic band resistance. One-hour session for three times a week for five weeks
16149425|NCT01785732|Procedure|Renal Denervation|Sympathetic renal denervation via renal arteries
16149426|NCT01785719|Behavioral|Commercial Weight Loss Program|Regardless of reproductive history, each participant will be provided with six months of the commercial weight loss program, Nutrisystem® D. Nutrisystem® D is a portion-controlled, low calorie, and low glycemic index meal delivery system that provides 1250-1500 kcal/day. It has been proven to help overweight adults achieve real and sustainable weight loss results. When meals and snacks are consumed as instructed, average weight loss is 1-2 lbs per week or 15-20% body weight by the end of six months. Nutrisystem® D offers a balanced meal plan that is consistent with the nutrition recommendations of the USDA Dietary Guidelines for Americans and American Diabetes Association. Each participant will be encouraged to take a daily multivitamin to help meet her micronutrient needs on the program.
16149427|NCT01785693|Drug|levobupivacaine, clonidine|
16149428|NCT01785680|Other|Integrated Protocol|Implement an integrated protocol in Sierra Leone for the management of MAM and non-complicated SAM that uses a single anthropometric indicator as well as the same food but in different doses to treat the continuum of malnutrition. MAM children will be given 75 g/kg/day of RUTF whereas SAM will be given 175 gr/kg/day of RUTF until MUAC>12.5 cm is reached. Then child will be given LNS, a bed net, albendazole, zinc, referral for immunizations compliant with current WHO recommendations, oral rehydration salts to give if the child has more than three loose watery stools in 24 hours, and asked to return for follow-up in 1, 3 and 6 months. Caretakers will be instructed to seek medical care sooner if the child has fever, poor appetite or signs of an acute illness.
16149429|NCT01785680|Other|Current protocol|Current protocol for treating MAM in emergencies is supplemental food distribution, often providing a fortified blended food (FBF) that requires cooking. This treatment is the standard today for treating children with MAM.
16149430|NCT01785641|Drug|ceftazidime+ciprofloxacin|2 synergistic antibiotics: ceftazidime IP + ciprofloxacin po for gram negative bacterial peritonitis
16149431|NCT01785641|Drug|ceftazidime monotherapy|ceftazidime IP for gram negative bacterial peritonitis
16149432|NCT01785641|Drug|cefazolin+gentamicin|cefazolin IP + gentamicin IP for gram positive bacterial peritonitis
16149433|NCT01785641|Drug|cefazolin monotherapy|cefazolin IP for gram positive bacterial peritonitis
16149434|NCT01785628|Dietary Supplement|Sarcosine Capsule|Sarcosine is a glycine transporter-1 (GlyT-1) inhibitor. By blocking glycine uptake, sarcosine increases synaptic glycine concentration to enhance NMDA receptor function.
16149435|NCT01785628|Dietary Supplement|Placebo Capsule|Placebo is dextrin composition.
16149436|NCT01785615|Drug|Atorvastatin|80mg
16149437|NCT01785615|Other|Placebo|80mg
16149438|NCT01785602|Drug|QAW039|Capsules
16149439|NCT01785602|Drug|Placebo|Capsules
16149440|NCT01785589|Procedure|coronary angiography|A 6 French arterial sheath was introduced into the radial artery. After administration of 5000 U heparin, the guiding catheter was advanced into the coronary ostium. Intracoronary nitroglycerin 0.2 mg was administered, and reference images were made. Significant CAD was defined as presentation of a stenosis ≥70 % in the three-epicardial vessels and ≥ 50 % in left main coronary disease. If necessary (at the discretion of the practitioner) the pressure wire was advanced across the stenosis, and Fractional flow reserve (FFR) was measured.
16149441|NCT01785576|Behavioral|Couple-Based CBT Intervention|Patients and partners will receive 4 sessions of a couple-based cognitive behavioral intervention focusing on communication and spousal support.
16149442|NCT01785563|Device|Nasal NIV-NAVA|Infants will be placed on nasal NIV-NAVA. Patients initial NAVA level will be set to generate a peak inspiratory pressure that is 8 cm of water greater than their current peak end expiratory pressure. If the infants are on nasal NIV-NAVA at the time of study entry their NAVA level will be increased by 50% rounded up to the nearest 0.1 cm of water per microvolt.
16149443|NCT01785550|Other|Ultrasound of nerve and muscle|Ultrasound of 6 muscles and 2 nerves will be performed.
16149444|NCT01785524|Drug|Beetroot Juice (Beet-It Stamina Shot) and Exercise Training|The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training.
16149445|NCT01785524|Other|Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training|The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training.
16149446|NCT01785511|Radiation|UVA Radiation|UVA radiation exposure for 20 minutes
16149447|NCT01785498|Behavioral|Supplementary resources|Clinical and educational resources for patients, their families and the professionals who care for them.
16149448|NCT01785485|Other|Integrative medicine primary care model|An integrative medicine primary medical care as defined by the Arizona Center for Integrative Medicine.
16149449|NCT01785472|Drug|LCZ696|LCZ696 200 mg tablet
16149450|NCT01785472|Drug|Olmesartan|Olmesartan 20 mg capsule
16149451|NCT01785472|Drug|Placebo of LCZ696|Placebo tablet of LCZ696 200 mg once daily
16149452|NCT01785472|Drug|Placebo of Olmesartan|Placebo capsule of olmesartan 20 mg once daily
16149662|NCT01783847|Drug|Methyl prednisolone|250 mg every 6 hours for 3 days.
16149453|NCT01785459|Drug|0.5% bupivacaine|The injection site will be prepared using common sterile technique with 2% chlorhexidine. 1.5 mL of 0.5% bupivacaine will be will be injected bilaterally in the paraspinal musculature of the cervical spine. Location would be approximately 1 cm superior to spinous process of C7 and approximately 2-3 cm laterally. The needle is inserted 1 to 1.5 inches into the paraspinous musculature at this level. A 27-gauge needle would be used to minimize tissue trauma and pain to the patient. Our method of injection is followed quite closely with the technique depicted in multiple retrospective studies. We chose to follow previous reported technique secondary to good clinical efficacy and impressive documented safety profile. Additionally, before injection, aspiration would be performed to lesson chance of intravascular injection.
16149454|NCT01785459|Drug|Standard Care|10 mg Intravenous injection of Prochlorperazine
16149455|NCT01785446|Drug|Effect of dexmedetomidine on cisatracurium and sufentanil consumption|In this intervention we compared the cisatracurium consumption, recovery index and sufentanil consumption between P2 and D. The reason we are comparing patients in group D with P2 is that because they belong to the same age group.
16149456|NCT01785446|Drug|Consumption of cisatracurium and sufentanil in different age groups.|For this intervention, we compared the cisatracurium consumption, refractory index and sufentanil consumption between group P1, P2 and P3.
16149457|NCT01785433|Drug|Tiotropium HFA BAI 4.5 mcg|
16149458|NCT01785433|Drug|Tiotropium HFA BAI 9.0 mcg|
16149459|NCT01785433|Drug|SPIRIVA® HandiHaler® 18 mcg/day|
16149460|NCT01785433|Drug|Spiriva® Respimat® 5 mcg/day|
16149461|NCT01785420|Drug|Trastuzumab|A single dose of Trastuzumab (Herceptin, Hoffman La Roche) at 8 mg/Kg as a 90 minute infusion in 250 ml of normal saline, in the window period of 14 days (both days inclusive) prior to the planned date of surgery.
16149462|NCT01785420|Drug|Placebo|A 90 minute intravenous infusion of saline as placebo
16149463|NCT01785407|Dietary Supplement|Iron Supplement (Ferrous Sulfate Dried)|Iron supplements of varying concentration will be administered to the four groups in the study. Iron bioavailability from the supplements will be assessed.
16149464|NCT01785394|Drug|5 grass allergen extract|30 patients will be subjected to sublingual immunotherapy with 5 grass allergen extract Staloral, starting with 1 spurt of 10 IR/ml increasing them daily stepwise to 10 spurts, switching then to 1 spurt of 300 IR/ml, increasing daily stepwise to 10 spurts, and then maintaining this dose from February till July. 30 patients will be on placebo.
16149465|NCT01785381|Other|Added value of coordinator|Added value of coordinator
16149466|NCT01785368|Other|Implementation of guidelines|The participating ER doctors are required to request imaging exams for their patients according to a guide mutually constructed by the emergency and imaging departments of the Nîmes university hospital.
16149467|NCT01785368|Other|Baseline observation|During this period of the study, baseline data will be collected.
16149468|NCT01785355|Other|Dental treatment|"The preliminary stage deals with:
~assessment of the clinical state of the patient by completing a detailed dental and periodontal chart
~education of the patient regarding correct oral hygiene habits;
~Phase I Therapy:
~plaque control : removal of dental plaque, calculus and root planning; antimicrobial therapy (local or systemic)
~evaluation of response to the treatment
~Phase II Therapy - surgical phase:
~extraction of hopeless teeth
~evaluation of the surgical results.
~Maintenance phase:
~periodic reevaluation of plaque and calculus and of periodontal conditions."
16149469|NCT01785342|Other|Biosample and Imaging Collection|Collection of listed biosamples and CT imaging.
16149470|NCT01785329|Drug|alirocumab SAR236553 (REGN727)|Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
16149471|NCT01785316|Procedure|IHP|
16149472|NCT01785303|Behavioral|CBT-I|Cognitive Behavior Therapy for Insomnia (CBT-I) consists of 4 weekly sessions delivered individually. The focus of these sessions is on modifying behaviors and cognitions related to sleep and insomnia.
16149473|NCT01785303|Procedure|CPAP|CPAP is an FDA-approved medical device used to treat obstructive sleep apnea. This device consists of a mask, hose, and machine that blows continuous air which maintains a consistent pressure of airflow preventing the upper airway from collapsing during sleep.
16149474|NCT01785290|Drug|Haloperidol 1 mg/q8h|"Patients receive prophylactic haloperidol until discharge from the ICU or when delirium occurs. In the latter case study drug will be stopped and patients will be subsequently treated according to the delirium protocol with open-label haloperidol. To avoid unnecessary risk for side-effects the dose will be halved in patients:
~aged ≥ 80 years
~weight ≤ 50 kg
~liver failure
~Patients with an adjusted dosage of study drug remain allocated to their original group.
~In case of occurrence of QTc-time prolongation the study drug will be stopped. After normalisation of QTc-time (<500msec.) the study drug will be restarted. If QTc-time becomes prolonged again, the study drug will be stopped definitively. The patient will remain allocated to the original study group."
16149475|NCT01785290|Drug|Haloperidol 2 mg/q8h|"Patients receive prophylactic haloperidol until discharge from the ICU or when delirium occurs. In the latter case study drug will be stopped and patients will be subsequently treated according to the delirium protocol with open-label haloperidol. To avoid unnecessary risk for side-effects the dose will be halved in patients:
~aged ≥ 80 years
~weight ≤ 50 kg
~liver failure
~Patients with an adjusted dosage of study drug remain allocated to their original group.
~In case of occurrence of QTc-time prolongation the study drug will be stopped. After normalisation of QTc-time (<500msec.) the study drug will be restarted. If QTc-time becomes prolonged again, the study drug will be stopped definitively. The patient will remain allocated to the original study group."
16149476|NCT01785290|Drug|Placebo|Sodium Chloride 0.9%
16149477|NCT01785264|Procedure|Non-operative treatment|All patients included in the study will be immobilized in equinus position for the first two weeks using a below-the-knee cast. Following the first two weeks the cast is replaced with a brace that will be used for additional six weeks during which the ankle angle will be adjusted from 3 heel-lifts to none. Patients randomized to non-operative treatment will have a cast applied within 3 days from injury.
16149478|NCT01785264|Procedure|Open surgery|All patients included in the study will be immobilized in equinus position for the first two weeks using a below-the-knee cast. Following the first two weeks the cast is replaced with a brace that will be used for additional six weeks during which the ankle angle will be adjusted from 3 heel-lifts to none.
16149596|NCT01784315|Drug|Artemisinin combination therapies (ACT)will be used for Chloroquine resistant P.vivax|4 tablets of ACT on 0,8,24,36,48 and 60 hours will be given for Chloroquine resistant P.vivax infection.
16149479|NCT01785264|Procedure|Mini-invasive surgery|"We will use the technique developed by Dr. Amlang and Professor Zwipp from Dresden, Germany. They have developed a protocol of mini-invasive surgery using specially adapted proprietary instruments.
~All patients included in the study will be immobilized in equinus position for the first two weeks using a below-the-knee cast. Following the first two weeks the cast is replaced with a brace that will be used for additional six weeks during which the ankle angle will be adjusted from 3 heel-lifts to none."
16149480|NCT01785251|Device|Neuromuscular Electrical Stimulation|Applied using a custom built, medically approved stimulator called the Duo-STIM. NMES to be applied to the calf muscles to elicit a muscular contraction to eject blood through the venous system.
16149481|NCT01785238|Other|renal echography|renal echography to analyse the kidney
16149482|NCT01785238|Other|Blood sampling|Blood sampling to analyse different parameters of renal function
16149483|NCT01785238|Other|collection of an urine sample|Collection of an urine sample to perform analysis of renal function parameters
16149484|NCT01785238|Other|Blood pressure measurement|
16149485|NCT01785225|Device|A product type of the modified commercial drape Tegaderm (R)|We test if a product type of the modified commercial drape Tegaderm(R) can bee used when taking blood samples under the guidance af ultrasound. The drape is used to keep the puncture area sterile and clean of ultrasound gel.
16149486|NCT01785212|Device|Stapler|stapler hepatectomy
16149487|NCT01785212|Device|CUSA (Cavitron ultrasonic aspirator; Valleylab, Boulder, CO)|CUSA is a well established device used for hepatic resection using ultrasound
16149488|NCT01785199|Procedure|Head elevation by an automatic adjustable bed|The automatic device is initiated when the patient suffers from apnea ≥ 10 seconds, which is detected by an ultra-wideband (UWB) sensor placed under the bed. The head will be slightly elevated at an angle of 10 degrees lasting 10 seconds and then be put down softly.
16149489|NCT01785186|Drug|SQ109|SQ109 300 mg
16149490|NCT01785186|Drug|Rifampicin|Rifampicin 10 to 35 mg/kg
16149491|NCT01785186|Drug|Moxifloxacin|Moxifloxacin 400mg
16149492|NCT01785186|Drug|isoniazid|isoniazid 75 mg
16149493|NCT01785186|Drug|pyrazinamide|pyrazinamide 400 mg
16149494|NCT01785186|Drug|ethambutol|ethambutol 275 mg
16149495|NCT01785186|Dietary Supplement|pyridoxine|pyridoxine 25 mg
16149496|NCT01785173|Procedure|Endoscopic-guided gauze pledgetting|By using a transnasal endoscope as a guide and a biopsy forceps, a gauze strip soaked with decongestant and anesthesia will be delivered to a selected nasal meatus chosen by anterior rhinoscopy.
16149497|NCT01785173|Procedure|Cotton-tipped applicator gauze pledgetting|In contrast to the endoscopic-guided, forceps-delivering method, a gauze strip is delivered to a selected meatus by a cotton-tipped applicator.
16149498|NCT01785160|Drug|Raltegravir|low dose oral administration
16149499|NCT01785160|Drug|Raltegravir|low dose oral administration
16149500|NCT01785160|Drug|Faldaprevir|medium dose oral administration
16149501|NCT01785147|Drug|BP1.4979|BP1.4979 at 3mg, 10mg, 15mg or placebo during 3 months.
16149502|NCT01785147|Drug|Placebo|
16149503|NCT01785134|Procedure|Omentectomy|
16149504|NCT01785134|Procedure|Gastric bypass operation|
16149505|NCT01785121|Behavioral|Structured access to a Wii game computer (Wii)|Patients who are randomized to the Wii group will be introduced to the Nintendo Wii game computer in an introduction lesson of approximately two hours and the Wii will be installed at home. During the first three months after inclusion, patients will be phoned after 2, 4, 8, 12 weeks to discuss their experiences with the Wii or to solve possible problems
16149506|NCT01785121|Behavioral|Motivational support only|The control group receives an protocolized exercise advice and telephone follow-up at 2, 4, 8 and 12 weeks
16149507|NCT01785108|Biological|GAD-Alum (Diamyd) 20 µg|
16149508|NCT01785108|Biological|GAD-Alum (Diamyd) 20 µg X 2|
16149509|NCT01785108|Drug|Vitamin D|
16149510|NCT01785108|Drug|Ibuprofen|
16149511|NCT01785095|Drug|FSH (Follicle Stimulating Hormone)|
16149512|NCT01785082|Drug|13-C-Methacetin|intravenous injection of 0.4% 13-C-Methacetin solution, once before partial liver resection, once after partial liver resection
16149513|NCT01785069|Device|Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection|Surgical implant
16149514|NCT01785056|Biological|Privigen|Subjects will receive 2 g/kg/mo of Privigen® for 6 months if randomized to the treatment group.
16149515|NCT01785043|Drug|Liraglutide|Liraglutide is available if pre-filled pens (6 mg/ml) as a solution for injection (Victoza®). One ml of solution contains 6 mg of Liraglutide (human glucagon-like peptide-1 analogue produced by recombinant DNA technology in Saccharomyces cerevisiae). One pre-filled pen contains 18 mg Liraglutide in 3 ml.
16149516|NCT01785043|Drug|Sitagliptin|Sitagliptin is available in 100 mg film-coated tablets (Januvia®). Each tablet contains sitagliptin phosphate monohydrate, equivalent to 100 mg sitagliptin.
16149517|NCT01785030|Drug|50% Nitrous oxide|
16149518|NCT01785004|Dietary Supplement|Vitamin D3 (cholecalciferol), 2000 IU per day|cholecalciferol
16149519|NCT01785004|Drug|omega-3 fatty acids (fish oil)|
16149520|NCT01784991|Drug|Hydromorphone|1mg of Hydromorphone at timepoint 0 and 1 mg of hydromorphone at 15 min timepoint.
16149521|NCT01784991|Drug|Usual care group|Patient will have pain treated at timepoint 0 as per usual care based on physician discretion. At 15 min timepoint, patients will be asked for pain level, and then subsequently treated as per physician discretion.
16149522|NCT01784978|Drug|Sunitinib|50 mg pd
16149523|NCT01784978|Drug|Everolimus|10 mg pd
16149524|NCT01784965|Drug|liraglutide|Dosing begins at 0.6 mg subcutaneous injection and increases each week, to 1.2 mg and maximum dose of 1.8 mg.
16149525|NCT01784965|Drug|Placebo|Double blinded will receive study pen with same dosing instructions starting at 0.6 mg, and each week increase to 1.2 mg and finally 1.8 mg at week three.
16149557|NCT01784705|Device|Transcranial bright light therapy|The bright light treatment was given transcranially via ear canals by using bright light device. The bright light was produced using two light-emitting diodes (LEDs). The bright light was transmitted into both ear canals by an optical fibre. Daily 12 minutes TBL was taken at home during forenoon.
16149597|NCT01784315|Drug|Chloroquine and Primaquine|Chloroquine:10mg/kg for day1,2 and 5mg/kg for day 3 Primaquine: 0.25mg/kg daily for 14 days.
16149526|NCT01784952|Dietary Supplement|Dietary intervention|The intervention program consisted of replacing of refined rice intake with 1/3 of legumes, 1/3 of barleys, and 1/3 of whole grains three times per day as a high carbohydrate source and increased vegetable intake to at least 6 units (30-70 g/unit) per day for sufficient dietary fiber intake. The subjects were recommended to drink no more than one alcoholic beverage drink (15 g alcohol) per day and were assigned physical activity consisting of a regular 30-min walk after dinner each day. Participants were also instructed to record their physical activity diary for 24 h every 4 weeks.
16149527|NCT01784926|Procedure|Intraocular lens repositioning by scleral suturing|
16149528|NCT01784926|Procedure|Intraocular lens exchange with retropupillary iris-claw lens|
16149529|NCT01784913|Biological|UV1 synthetic peptide vaccine and GM-CSF|
16149530|NCT01784900|Drug|Catumaxomab 100µg|
16149531|NCT01784900|Drug|Catumaxomab 140µg|
16149532|NCT01784887|Drug|Procellera|PROCELLERA TM is an FDA-cleared bioelectrical dressing delivered in a sterile, single layer sheet consisting of a flexible polyester fabric layer containing silver and zinc, which are held in position on the polyester with a biocompatible binder.
16149533|NCT01784874|Biological|Purified Vero Rabies Vaccine (VRVg) - Serum Free|0.5 mL, Intramuscular
16149534|NCT01784874|Biological|Imovax® Rabies: inactivated rabies vaccine|1.0 mL, Intramuscular
16149535|NCT01784861|Drug|X-82|
16149536|NCT01784861|Drug|Everolimus|
16149537|NCT01784848|Procedure|Laparoscopic Roux-en-Y gastric bypass (LRYGB)|Laparoscopic Roux-en-Y gastric bypass (LRYGB)is the one of the techniques of bariatric surgery
16149538|NCT01784848|Other|Clinical treatment|Medical treatment aiming the control of risk factors for cardiovascular diseases (including adequate control of blood pressure), psychological assistance and dietetic advice for body weight reduction.
16149539|NCT01784835|Other|osteopathic manipulative treatment|Patients from this group received osteopathic treatments twice a week for the entire length of stay in the unit.
16149540|NCT01784835|Other|Usual care|Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.
16149541|NCT01784822|Device|Zenapro™ Hybrid Hernia Repair Device|Device will be placed during open or laparoscopic hernia repair.
16149542|NCT01784809|Behavioral|Multimedia WORTH|"The Multimedia WORTH intervention features the same core elements as the original version, but these core elements are translated into interactive tools and culturally tailored video vignettes designed to enhance group learning and individualized feedback. Participants will interact with Multimedia WORTH at two levels: (1) group materials will be delivered via computer projection onto a screen and (2) participants will complete individual activities and create journal logs tracking their progress on personalized goals on their personal user accounts using laptop computers. The computer multimedia support tool includes text, imagery, animations, audio and video in a format that guide the facilitator's delivery of the intervention. ***To view pilot features of the Multimedia WORTH intervention in development, please visit the following web address:
~http://ccnmtl.columbia.edu/projects/worth/presentation"
16149543|NCT01784809|Behavioral|Traditional WORTH|The basic format of each WORTH session remains consistent following a sequence of 5 steps: (1) an opening (quote, song, poem) which will provide a brief culturally relevant point of inspiration to engage participants (2) Check-in to review material from the previous session, and to discuss any incidents where participants engaged in risk behaviors and to acknowledge positive ways in which women used new skills to avoid HIV risk; (3) a discussion to raise awareness of links between IPV, drug-related activities, and HIV risks; (4) a skills-building component relevant to the discussion; and (5) review and update participant needs, homework assigned for skills-building at home, and a closing ritual. The WORTH intervention consists of four 2-hour group sessions that are led by a female facilitator.
16149544|NCT01784809|Behavioral|Wellness Promotion|
16149545|NCT01784796|Behavioral|Mindfulness Based Stress Reduction|8 week Mindfulness Based Stress Reduction Program
16149546|NCT01784796|Behavioral|Health Education Program|8 week Health Education Program
16149547|NCT01784783|Behavioral|HOPE Intervention|"If the male partner chooses not to complete the study questionnaire, he may decline and participate only in the HOPE intervention component of the study. (This does not preclude the possibility of the female partner continuing to participate in the study.) Investigators anticipate that this will occur and also expect that some women and male partners randomized to the intervention arm will refuse the HOPE intervention when offered. Study staff will attempt to collect data on reasons for refusal to participate and will continue to follow these couples through 6 months postpartum to collect maternal and infant outcome data, provided the female partner does not withdraw from the study.
~Key educational messages will be presented using an electronic tablet highlighting key messages and will include with relevant images as visual aids. This will help to facilitate comprehension and ensure that all relevant materials are covered during each intervention session."
16149548|NCT01784783|Behavioral|INVITE Intervention|Women will receive a clinic invitation to give to their male partners to attend the next antenatal visit for couple HIV counseling and testing.
16149549|NCT01784770|Drug|Azithromycin IV|"The recommended dose of ZITHROMAC (azithromycin for injection) for the treatment of adult patients with community-acquired pneumonia due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7- to 10-day course of therapy.
~The recommended dose of ZITHROMAC (azithromycin for injection) for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy."
16149550|NCT01784757|Drug|ODM-201 Tablet A|Tablet A formulation of ODM-201
16149551|NCT01784757|Drug|ODM-201 Tablet B|Tablet B formulation of ODM-201
16149552|NCT01784757|Drug|ODM-201 capsule formulation|Capsule formulation of ODM-201
16149553|NCT01784744|Other|Hydroworx Pool at 98 degrees Fahrenheit|
16149554|NCT01784744|Other|Hydroworx Pool at 102 degrees Fahrenheit|
16149555|NCT01784731|Behavioral|Willingness to pay|
16149556|NCT01784718|Drug|Buphenyl|
16149558|NCT01784705|Device|Transcranial placebo treatment|The placebo treatment was given transcranially via ear canals by placebo device. Daily 12 minutes placebo treatment was taken at home during forenoon.
16149560|NCT01784666|Drug|Isradipine|The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to isradipine versus placebo add-on for 4 weeks, with the placebo nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the isradipine treatment effect. Subjects who respond in phase 1, and all subjects who receive isradipine in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed.
16149561|NCT01784666|Drug|Placebo|Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to isradipine vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed.
16149562|NCT01784653|Behavioral|iMET|Self-completed, computerized motivational enhancement therapy
16149563|NCT01784653|Behavioral|MET|Clinician-delivered Motivational Enhancement Therapy
16149564|NCT01784640|Drug|Hsp90 inhibitor AUY922|Given IV
16149565|NCT01784640|Drug|pemetrexed disodium|Given IV
16149566|NCT01784640|Other|pharmacological study|Correlative studies
16149567|NCT01784640|Other|laboratory biomarker analysis|Correlative studies
16149568|NCT01784627|Behavioral|c-ASBI|Participants in the c-ASBI group will complete a computerized screen for alcohol, cannabis, tobacco and other drugs, then view their screen score and 10 pages of information about the health effects of substance use and true-life stories on the computer. Their provider will see a report of their screen results and provide advice to stop or decrease their use, or, for those at high risk, referral to complete a computerized motivational enhancement therapy intervention.
16149569|NCT01784614|Drug|LY2624803 - Solution|Administered orally as reconstituted solution
16149570|NCT01784614|Drug|LY2624803 - Capsule|Administered orally as a capsule
16149571|NCT01784614|Drug|Placebo - Solution|Administered orally as solution
16149572|NCT01784614|Drug|Placebo - Capsule|Administered orally as a capsule
16149573|NCT01784588|Device|Solyx Single Incision Sling System|Solyx Single Incision Sling System
16149574|NCT01784588|Device|Obtryx II Sling System|Standard outside-in transobturator sling
16149575|NCT01784575|Other|Patient Navigator Intervention|The Patient Navigator Intervention will include 2 - 20 minute sessions with a patient navigator in which women are shown publicly available health care quality data about local pediatric practices on a non-profit quality collaborative's web site.
16149576|NCT01784562|Drug|Adempas (Riociguat, BAY63-2521)|Individual dosing of riociguat between 0.5 and 2.5 mg three times daily based on patient's well being and blood pressure. (The individual optimal dose should be determined during the initial 8-week titration phase based on patient's monitoring of systolic blood pressure and well-being.)
16149577|NCT01784549|Drug|Cisplatin Docetaxel Gefitinib Pemetrexed Vinorelbine Gemcitabine|
16149578|NCT01784536|Drug|Single-Dose IV Oritavancin Diphosphate|Oritavancin will be administered as a single IV infusion. The infusion will last approximately 3 hours.
16149579|NCT01784523|Drug|Hydroxychloroquine|
16149580|NCT01784510|Procedure|distance of dissection of gastrocolic ligament from pylorus|
16149581|NCT01784484|Other|No intervention|
16149582|NCT01784471|Device|Magic Foot™|Magic Foot™ is a shoe, providing massage together with acupressure or reflexology functions. The device is fully remotely operated and controlled.
16149583|NCT01784445|Drug|Ceftazidime|Patient undergone ERCP will receive either diclophenac sodium suppositories(100mg)plus placebo or ceftazidime (2g i.v.) plus placebo before procedure
16149584|NCT01784432|Device|Low-level laser therapy and training|
16149585|NCT01784432|Other|Training|
16149586|NCT01784419|Drug|ivacaftor|Eligible subjects were randomized to ivacaftor 150 mg by mouth twice a day for 14 days followed by placebo for 14 days, or vice versa. Randomization was based on a computer-generated schedule produced by the research pharmacy, which was concealed from study personnel until study completion. Ivacaftor was purchased at full retail cost and encapsulated with sucrose to match the sucrose-filled placebo capsules. Prior to beginning study drug, there was a 2-week run-in period to ensure clinical stability, assessed by modified Fuchs criteria and pulmonary function. There was a washout period of a minimum of 14 days between study drug cycles to account for carryover effect. The washout period was extended to 6 weeks for subjects on alternating cycles of inhaled antibiotics to coordinate the study drug cycle with the inhaled antibiotic cycle.
16149587|NCT01784419|Drug|Placebo|Eligible subjects were randomized to ivacaftor 150 mg by mouth twice a day for 14 days followed by placebo for 14 days, or vice versa. Randomization was based on a computer-generated schedule produced by the research pharmacy, which was concealed from study personnel until study completion. Ivacaftor was purchased at full retail cost and encapsulated with sucrose to match the sucrose-filled placebo capsules. Prior to beginning study drug, there was a 2-week run-in period to ensure clinical stability, assessed by modified Fuchs criteria and pulmonary function. There was a washout period of a minimum of 14 days between study drug cycles to account for carryover effect. The washout period was extended to 6 weeks for subjects on alternating cycles of inhaled antibiotics to coordinate the study drug cycle with the inhaled antibiotic cycle.
16149588|NCT01784406|Behavioral|Autonomy supportive counselling|
16149589|NCT01784393|Radiation|chemoradiation|
16149590|NCT01784380|Drug|Diane-35;metformin;Clomiphene citrate; Human menopausal gonadotropin|
16149591|NCT01784367|Device|vv-ECCO2R (Novalung GmbH, Germany)|Treatment with the extracorporeal lung assist (ECLA) The ECLA is a pump driven (centrifugal pump) venovenous circuit, which removes carbon dioxide from the patients blood by means of a membrane through which the patients blood runs on the one side of the membrane and sweep gas on the other side removing the patient´s carbon dioxide. Blood flow range from 0.5 to 4.5 l/min and sweep gas flow between 1 and 10 l/min. At blood flows of 2 l/min and higher the device also oxygenates the patients blood. The diameter and length of cannulas and the sites of venous insertions are left to the decision of the treating physician. Cannulas are inserted in seldinger technique under sterile conditions. Function and patency of the extracorporeal circuit requires mild therapeutic anticoagulation.
16149592|NCT01784354|Other|Acupressure|
16149593|NCT01784354|Other|Acupressure dilatation|
16149594|NCT01784354|Behavioral|education|
16149595|NCT01784328|Device|Peristeen Bowel Irrigation System|A complete system for bowel Irrigation to manage bowel dysfunction
16149598|NCT01784302|Dietary Supplement|Multivitamins|
16149599|NCT01784302|Dietary Supplement|Sodium bicarbonate|
16149602|NCT01784276|Behavioral|Video|"Video peer modeling: The video demonstrates various stages of the dental visit experience. Children assigned to intervention Groups B or D reviewed the video at least once, but as many times as possible before the follow up visit.
~Video goggles: This is a sunglass style video eyewear that contains two computer screens that can be used to watch 2 or 3D movies. Subjects randomized to Group C or D watched a 2D movie during the return visit, using the video goggles. Subjects who refused or were unable to wear the goggles watched the movie using a hand held portable DVD player."
16149603|NCT01784263|Behavioral|Individual Cognitive Behavioral Therapy|Therapists will work with families for 32 weekly sessions, each lasting 90 minutes (45 minutes with the child and 45 minutes with the family/parents), implementing the CBT manual for children with ASD (Wood et al., 2007).
16149604|NCT01784263|Behavioral|Standard Community Treatment|In this condition, the child meets with a therapist for 32 weekly sessions, each 90 minutes. Therapists use an established manual to administer a standard community treatment.
16149605|NCT01784250|Drug|Clonidine|Clonidine 150 mcg tablet single dose, to receive by mouth one hour before surgery
16149606|NCT01784250|Drug|Propranolol|Propranolol 40 mg tablet single dose, to receive by mouth one hour before surgery
16149607|NCT01784250|Drug|Placebo|Sugar pill manufactured to mimic a drug
16149608|NCT01784237|Procedure|anterior meatoscopy|The nasal vestibule is the most anterior part of the nasal cavity. It is lined by the same epithelium of the skin (stratified squamous epithelium) but not respiratory epithelium (pseudostratified columnar ciliated epithelium) so that an endoscope tip in this region would hardly causes trauma or bleeding. Before being inserted gently into the nasal vestibule for anterior rhinoscopy, the endoscope tip is applied with 2% lidocaine gel and then sprayed with 10% liquid lidocaine. This procedure can provide mild vestibular anesthesia which can prevent patients from sneezing when the vibrissae hair is irritated by the endoscope tip. Instead of holding the insertion tube as usual, an endoscopist holds the bending section for better control of the distal tip during anterior meatuscopy.
16149609|NCT01784237|Procedure|Nasal sniff test|All patients in the control group receive a sniff test in the left lateral decubitus (LLD) position directed and recorded by an assistant nurse. This test has been conducted for decades and is still used by many transnasal endoscopists, otolaryngologists, and pediatrics. In brief, the more patent nostril is selected by the patient inhaling through only one nostril with the other sealed by the examiner's index ﬁnger. Patients are asked to indicate which of their nostrils is most patent. If neither is more patent, the right nostril is chosen by default. The middle meatus is more difficult to examine and may be less well anesthetized than other structures. Thus, the inferior nasal meatus is selected for each case because the inferior meatus is usually the largest of the three nasal meatuses.
16149610|NCT01784224|Procedure|Blom Low Profile Voice Cannula/Passty-Muir Speaking Valves|
16149611|NCT01784211|Drug|LY2605541|
16149612|NCT01784211|Drug|Insulin Glargine|
16149613|NCT01784198|Dietary Supplement|Protein Intake|Oral consumption of Eight hourly experimental meals- Includes 4 tracer-free experimental meals containing a mixture of free amino acids, calories from a flavored liquid and protein free cookies and 4- labeled amino acid experimental meals.
16149614|NCT01784185|Procedure|virtual bronchoscopy guided transbronchial needle aspiration|
16149615|NCT01784185|Procedure|endobronchial ultrasound guided transbronchial needle aspiration|endobronchial ultrasound guided transbronchial needle aspiration (EBUS-TBNA) of mediastinal lesions
16149616|NCT01784172|Device|electroacupuncture group|Procedure: electro-acupuncture;Points: Bilateral Zhongliao (BL33) Huiyang(BL35).Specially-made pad is stick on pierced acupoints. Bilateral BL33 are given acupuncture of 50～60mm with 30～45°angle to inward and downward by 75mm filiform needle. Bilateral BL35 are given acupuncture of 50～60mm to outward and upward by 75mm filiform needle. Twirl, lift and thrust for 3 times, until local sour and heavy feeling coming.The electric stimulator is applied to bilateral BL33 and BL35, with continuous wave,50 Hz and electric current 1- 5mA.Every session lasts for 30 min per day.The participants are treated continuously for 6 weeks for 3 sessions a week, 18 sessions for each patient in all. The treatment is designed based on recent literature research in 10 years, former result and expert consensus.
16149617|NCT01784172|Device|sham electroacupuncture group|Procedure: sham electroacupuncture;Points: Bilateral sham Zhongliao (BL33) sham Huiyang(BL35).Specially-made pad is stick on pierced acupoints. Both sham BL33 and BL35 are given non-penetrating needling with blunt needle. Twirl, lift and thrust for 3 times. The sham electric stimulator is applied to bilateral sham BL33 and sham BL35. The mental wire has been cut off with a same outlook as the treatment group. The electric stimulator is looked normal but with no current output. Length of Treatment and the treatment sessions are the same as treatment group.
16149618|NCT01784159|Drug|Aspirin|Aspirin administration for 7 days
16149619|NCT01784146|Other|Oxygen|"For inhalation of oxygen, we used a noninvasive delivery system, semi - closed (Figure 3) consisting of a non-toxic face mask with two unidirectional valves - inspiratory and expiratory branch - connected to the
~nebulizer (Airlife Misty Neb, Baxter; Valencia, CA, USA). In the inspiratory branch, a reservoir bag (Hudson RCI, USA) with capacity of 2.5 L was connected, in order to avoid dilution of the gas. This skin was fixed to the patient's face to prevent leakage and to maintain adequate pressurization and improved patient compliance to the PEEP. The nebulizer was fed by a flow of 8 l / min of oxygen."
16149620|NCT01784146|Other|Heliox|"For inhalation of heliox, we used a noninvasive delivery system, semi - closed consisting of a non-toxic face mask with two unidirectional valves - inspiratory and expiratory branch - connected to the
~nebulizer (Airlife Misty Neb, Baxter; Valencia, CA, USA). In the inspiratory branch, a reservoir bag (Hudson RCI, USA) with capacity of 2.5 L was connected, in order to avoid dilution of the gas. This skin was fixed to the patient's face to prevent leakage and to maintain adequate pressurization and improved patient compliance to the PEEP. The nebulizer was fed by a 11 l / min of heliox for the heliox group in accordance with a protocol of Hess et al."
16149621|NCT01784146|Other|PEEP|PEEP supplied was 10 cm H2O through valve (Vital Signs,Totowa, USA) attached to the expiratory branch.
16149622|NCT01784133|Drug|omiganan|
16149623|NCT01784133|Drug|placebo|
16149624|NCT01784120|Drug|Doxorubicin/Genexol-PM|
16149625|NCT01784107|Drug|Belotecan and Ifosfamide|
16149626|NCT01784094|Device|StromaGlide|
16149663|NCT01783834|Drug|Gefitinib|compare progression free survivla rate and safety to both drugs
16149664|NCT01783834|Drug|Pemetrexed|compare PFS rate, safety to both drugs
16149869|NCT01782352|Dietary Supplement|Fish oil placebo|
16149627|NCT01784081|Other|Palliative care with decision aids|Participant is followed by the palliative care team, and at each visit, patient will assess their distress and symptoms. Patients facing a treatment decision will receive a Patient Information Program link to review the diagnosis, prognosis, specific benefits and risks with the proposed chemotherapy.
16149628|NCT01784068|Drug|Nilotinib followed by treatment-free|Nilotinib is being used as commercial available capsules (except in Japan where clinical supplies is used) of 150 mg and 200 mg strength. Treatment occurs during consolidation, continuation, prolonged continuation, re-initiation and re-initiation-2 phases of the study.
16149629|NCT01784042|Drug|Placebo|placebo
16149630|NCT01784042|Drug|Lovaza|
16149631|NCT01784042|Other|Dietary energy restriction|
16149632|NCT01784029|Drug|Vitamin D3|Doses are as mentioned above. Will repeat 3 month cycles of treatment if still deficient at 3 month follow up.
16149633|NCT01784016|Radiation|[11C]-PHNO|[11C]-PHNO will be administered once intravenously to conduct Positron Emission Tomography (PET) measurements of dopamine D2/D3 binding potential.
16149634|NCT01784003|Device|Powered ankle-foot prosthesis|
16149635|NCT01783990|Drug|Hydroxyurea|Parents and child's doctor may plan to use or not to use hydroxyurea.
16149636|NCT01783977|Biological|DNA-HIV-PT123 vaccine|DNA-HIV-PT123 4 mg/mL; administered as 1 mL IM in participant's deltoid
16149637|NCT01783977|Biological|NYVAC-HIV-PT1 vaccine|NYVAC-HIV-PT1 at greater than or equal to 5x10^6 plaque-forming units (PFU)/ml for a planned maximum dose of 1.2x10^8 PFU/ml; administered as 1 mL IM in participant's deltoid
16149638|NCT01783977|Biological|NYVAC-HIV-PT4 vaccine|NYVAC-HIV-PT4 at greater than or equal to 5x10^6 PFU/ml for a planned maximum dose of 1.1x10^7 PFU/ml; administered as 1 mL IM in participant's deltoid
16149639|NCT01783977|Biological|Placebo for DNA-HIV-PT123 vaccine|Placebo for DNA-HIV-PT123 administered as 1 mL IM in participant's deltoid
16149640|NCT01783977|Biological|Placebo for NYVAC-HIV-PT1 vaccine|Placebo for NYVAC-HIV-PT1 vaccine administered as 1 mL IM in participant's deltoid
16149641|NCT01783977|Biological|Placebo for NYVAC-HIV-PT4 vaccine|Placebo for NYVAC-HIV-PT4 vaccine administered as 1 mL IM in the participant's deltoid
16149642|NCT01783964|Drug|[14C]-Elacytarabine|Single intravenous administration
16149643|NCT01783951|Biological|DC-CIK|Patients will be receive DC-CIK cell therapy at days 15, 17 and 19 per cycle and received cycles of treatment once every 21 days.
16149644|NCT01783951|Drug|S-1|The dose of S-1 is determined according to the body surface area as follows: <1.25 m2, 40 mg; 1.25 to <1.5 m2, 50 mg; and ≥1.5 m2, 60 mg, given twice daily after meals for 14 days followed by 7 days rest.
16149645|NCT01783951|Drug|Cisplatin|Cisplatin is administered at 75 mg/m2 intravenously over 1 to 3 hours every 21 days.
16149646|NCT01783938|Biological|Nivolumab|
16149647|NCT01783938|Biological|Ipilimumab|
16149648|NCT01783925|Drug|Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)|Patients in daily life clinical practice treatment receiving EYLEA according to indication on the label.
16149649|NCT01783912|Behavioral|Cognitive / Motivational Individual Sessions|Cognitive Motivational subjects will receive four evidence-based preparatory interventions (motivational interviewing, smoking reduction, practice quit attempt, and pre-quit use of nicotine replacement medication) (25 - 30 minutes each).
16149650|NCT01783912|Behavioral|Attention Control Individual Sessions|Attention control subjects will receive four placebo individual sessions (25-30 minutes each). The session content will reemphasize group discussion of the personal health risks from smoking.
16149651|NCT01783912|Drug|Nicotine Patch|Cognitive Motivational subjects will be asked to take one 21 mg patch/day for 4 weeks.
16149652|NCT01783912|Behavioral|Group Curriculum|Everyone to be put into the experimental or active comparator group will attend 2 group meetings over two weeks each of which lasts 40 minutes. Experience with the Kicking Butts program indicates that this duration is well tolerated by this population. The content of these two group meetings is based on the Kicking Butts program. The Kicking Butts program was initially developed as a cessation intervention, but consistent with the literature about the need to prepare this population to make a quit attempt, has evolved to emphasize preparation for quitting. Topics addressed include the health consequences of smoking, reasons to quit and methods of quitting.
16149653|NCT01783899|Device|Hemospray|"Patients will be resuscitated as needed to achieve hemodynamic stability in preparation for endoscopy within 24 hours of hospital admission.
~once the bleeding point will be identified at endoscopy, the delivery catheter will be inserted through the endoscope and positioned toward the lesion, leaving 1-2 cm between the bleeding site and the catheter tip.
~Hemospray will be then delivered in short spray bursts (for 1-2 seconds) until hemostasis was confirmed.
~Once bleeding was controlled , the bleeding site will be observed for 5 minutes under endoscopy.
~Oral food and fluid will be with held from the patient for 24 hours. Intravenous octreotide and esomeprazole will given for up to 24 hours. Patients will be closely monitored for signs of recurrent bleeding for 24 hours post procedure.
~Recurrent bleeding will be diagnosed any patient experiencing recurrent bleeding will treated according to the institutional standard of care"
16149654|NCT01783886|Biological|Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
16149655|NCT01783886|Biological|Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
16149656|NCT01783886|Procedure|Macular Laser Photocoagulation|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
16149657|NCT01783873|Other|standardized bronchial challenge test (SCL SCL • • GenaSOL ™ GenaSIC ™)|At Visit 1: Patients are selected and they will receive a metacholine challenge test during and outside of work. After randomization, patients undergo a standardized bronchial challenge test (SCL SCL • • GenaSOL ™ GenaSIC ™) to either an wheat flour allergen extract or didecyldimethylammonium chloride or placebo. Each bronchial challenge test is followed by blood sampling at different time points and induced sputum. The immediate bronchial response and late bronchial response will be recorded.
16149658|NCT01783860|Drug|Azithromycin|
16149659|NCT01783860|Drug|Doxycycline|
16149660|NCT01783847|Drug|Recombinant human erythropoietin (EPO)|4000 units per vial
16149661|NCT01783847|Other|Observation|Just observation
16149665|NCT01783821|Drug|Budesonide|Subjects will receive the standard aerosolized dose of budesonide (0.5 mg).
16149666|NCT01783821|Drug|Placebo|Aerosolized normal saline will be prepared to mimic the intervention arm, with the quantity, appearance and timing of the doses the being the same.
16149667|NCT01783821|Drug|Formoterol|Subjects will receive the standard aerosolized dose of formoterol (20 mcg) .
16149668|NCT01783808|Other|Supplemental oxygen|"Patients are supposed to use ambulatory supplemental oxygen during physical activity. The intervention will last for six months.
~In addition to supplemental oxygen the patients will be stimulated by a physiotherapist to be more physically active. A behavioural medicine intervention will be used."
16149669|NCT01783795|Other|Genetic Analysis|
16149670|NCT01783782|Behavioral|DIET|clear liquid diet for 12 hours on the day before CE, followed by an overnight fast
16149671|NCT01783782|Drug|polyethylene glycol 4000 solution with simethicon|patients received a high volume regime consisting of a 50 mL/Kg (up to 2 Lt/die) of PEG solution the evening before the examination, followed always by an overnight fast
16149672|NCT01783782|Drug|simethicon|Patients received 20 mL oral simethicone (Panamir, DMG, Italy, containing 40 mg simethicone in 1mL emulsion) and 200mL water 30 minutes before capsule ingestion
16149673|NCT01783769|Behavioral|"Low O.R. Traffic"|"Low OR Traffic protocol will restrict personnel movement thru the operating room to a bare minimum of personnel traffic."
16149674|NCT01783756|Drug|lapatinib ditosylate|Given PO
16149675|NCT01783756|Drug|everolimus|Given PO
16149676|NCT01783756|Drug|capecitabine|Given PO
16149677|NCT01783756|Other|laboratory biomarker analysis|Correlative studies
16149678|NCT01783743|Other|TT Training Program and TT Screening Card|The intervention is an additional half day training program on trichiasis recognition (TT Training Program) and a TT Screening card to assist community treatment assistants in recognizing TT cases and referring them to surgery.
16149679|NCT01783717|Drug|Exenatide|5mcg twice a day for 4 weeks increased to 10 mcg twice a day for 8 weeks
16149680|NCT01783704|Dietary Supplement|Nutrition|Participants receive 2000 IU vitamin D3, 600 mg calcium, and a multivitamin daily for the duration of the study. Nutritional counseling is also provided. Participants are screened at time of randomization to assess nutritional risk using the Mini Nutritional Assessment-Short Form and contacted by a registered dietician (RD) within 7 days of randomization. Those who score ≤7 (malnourished) and participants with baseline serum albumin 2.5-3.5 g/dl receive a visit from an RD with follow-up a week later. Participants who score 8-11 (at risk of malnutrition) and have serum albumin level >3.5 g/dl receive a phone call from the RD and may receive an in-person visit if warranted. Those screening in the normal range (12-14) and have serum albumin level >3.5 g/dl receive a phone call from the RD. Weight is monitored every 4 weeks. Those who lose 2% or more body weight receive a call from the RD. Those who lose 5% or more body weight between baseline and follow-up may be referred to an RD.
16149681|NCT01783704|Behavioral|PUSH|Strength components of the muscle performance intervention are performed using a portable progressive resistive exercise device (Shuttle® MiniPress, Contemporary Design Company, P.O. Box 5089, Glacier, Washington 98244). Muscle performance focuses on bilateral hip extensors, hip abductors, knee extensors, and plantar flexors. Balance and strength are addressed with additional exercises performed while standing. The endurance intervention begins with 2-3 minutes of continuous upper and lower extremity active range of motion (AROM) with the participant sitting in order to increase the participants' heart rate (HR) or exertion closer to the target zone. The participant is then asked to walk on level surfaces and/or up and down steps to keep the HR within the training zone for 20 minutes.
16149682|NCT01783704|Behavioral|PULSE|During the AROM exercises, participants work to increase flexibility and range of motion. Exercises include the neck, shoulders, arms, trunk, hips, knees and ankles. During all AROM exercises, the participant focuses on deep breathing techniques. The second part of the session uses transcutaneous electrical nerve stimulation (TENS) on lower extremity muscle groups to decrease pain, thereby allowing greater ease of mobility. TENS uses low-level electrical current to stimulate superficial cutaneous nerve fibers through the skin. Flexible carbonized, disposable electrodes coated with a self-adhesive conductive polymer will be applied to the skin bilaterally near the motor points on muscle bellies (the gluteal complex, the quadriceps, and the gastrocnemius) for 7 minutes per muscle group.
16149683|NCT01783691|Drug|NKTT120|
16149684|NCT01783678|Drug|Sofosbuvir|Sofosbuvir 400 mg tablet administered orally once daily
16149685|NCT01783678|Drug|RBV|Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
16149686|NCT01783665|Other|aerobic exercise|
16149687|NCT01783665|Other|home exercise program|
16149688|NCT01783652|Behavioral|Intervention group|Participants in the intervention group will have access to the anti-depression website modified and translated by the University of Hong Kong. 10 chapters on understanding depression, identifying depression symptoms and techniques tackling depression will be covered. Exercises and built-in questionnaires on measuring emotions will be provided in the website. Additional telephone follow-up counseling at the third, sixth and twelfth months will be conducted.
16149689|NCT01783639|Procedure|Carotid Artery Stent|Assessment of the study device (WIRION) during carotid artery stenting procedure in comparison to a performance of FDA approved filter type embolic protection devices
16149690|NCT01783626|Device|Evodial|
16149691|NCT01783626|Device|Evodial+ Condition B1|
16149692|NCT01783626|Device|Evodial+ Condition B2|
16149693|NCT01783626|Device|Evodial+ Condition C|
16149694|NCT01783613|Dietary Supplement|Docosahexaenoic acid administration: 50 mg/kg/day during 12 months|
16149695|NCT01783613|Dietary Supplement|Placebo: 50 mg/kg/day during 12 months|
16149696|NCT01783600|Device|NanoCross .014 balloon catheter|
16149697|NCT01783587|Drug|Afatinib|Taken orally once per day
16149698|NCT01783587|Drug|Docetaxel|15 mg/m2, given intravenously once per week
16149699|NCT01783587|Radiation|Radiation Therapy|Daily, Monday-Friday, for six to seven weeks
16149700|NCT01783574|Drug|Testosterone|
16149701|NCT01783574|Drug|Placebo|
16149821|NCT01782768|Device|noninvasive positive pressure ventilation|the assisted level of the noninvasive proportional assist(PAV) and pressure support ventilation(PSV) on Neural respiratory drive(NRD) in recovering patients with acute exacerbation of chronic obstructive pulmonary disease
16149702|NCT01783561|Drug|Caffeine|Infants will receive a blinded dose of either placebo (IV normal saline) or IV caffeine citrate 20mg/kg infused over 10 minutes within the first 2 hours of life. They will receive a blinded dose of the opposite of what they received in the DR (placebo or caffeine) at 6 hours of life. Therefore, the intervention is timing of initial caffeine dose.
16149703|NCT01783548|Drug|BDP Nasal Aerosol|
16149704|NCT01783548|Drug|Placebo|
16149705|NCT01783535|Drug|vincristine|Given via minibag/gravity flow.
16149706|NCT01783535|Drug|topotecan|Given IV over 30 minutes.
16149707|NCT01783535|Drug|filgrastim|Given subcutaneously 24-36 hours after chemotherapy for 7-10 days, until absolute neutrophil count (ANC) is >2,000/µL on one occasion after the expected nadir.
16149708|NCT01783535|Drug|PEG-filgrastim|Given subcutaneously 24-36 hours after chemotherapy for 7-10 days, until ANC is >2,000/µL on one occasion after the expected nadir.
16149709|NCT01783535|Drug|carboplatin|Given IV over 60 minutes. Given periocular (subtenon/subconjunctival).
16149710|NCT01783535|Other|focal therapy|Focal treatments will be administered at the discretion of the treating team to strata A, B and D. In select cases of very early stage retinoblastoma (Stratum A), participants may receive focal therapies only and chemotherapy will be held at the discretion of the treating team. If there is any evidence of progression or unsatisfactory results, the participant will begin chemotherapy as per Stratum A. For selected participants an effort will be made to perform sequential chemo-thermotherapy. In these cases, carboplatin will be administered one or two hours prior to thermotherapy.
16149711|NCT01783535|Drug|etoposide|Given IV. Participants who cannot tolerate etoposide may be given etoposide phosphate (Etopophos(R)).
16149712|NCT01783535|Drug|cyclophosphamide|Given IV.
16149713|NCT01783535|Drug|MESNA|Given IV before CYCLO and at 3, 6 and 9 hours after CYCLO.
16149714|NCT01783535|Drug|doxorubicin|Given IV on Day 1 of Cycles 2, 4 and 6 in Stratum C high-risk.
16149715|NCT01783535|Procedure|enucleation|Eye removal due to advanced disease in Strata C and D participants.
16149716|NCT01783535|Radiation|external beam radiation or proton beam radiation|EBRT or proton beam radiation will be administered to any eye in which the disease is considered to be not controllable with focal treatments alone, and in participants with enucleated eyes in which high risk of orbital and/or central nervous system disease is documented histologically (high-risk group with disease extension beyond the sclera or cornea, or beyond the cut end of the optic nerve). EBRT will be administered using standard techniques practices with the objective of limiting dose to normal tissues including the hypothalamic-pituitary unit, supratentorial brain, orbit, cochleae and contralateral eye when indicated. Participants will be evaluated on an individual basis to determine whether they might benefit from referral for proton therapy.
16149717|NCT01783522|Drug|glutamine|Dose of 15 grams twice times daily (to equal 30 grams a day) for a period of 4 months.
16149718|NCT01783522|Other|quality-of-life assessment|Ancillary studies
16149719|NCT01783522|Other|placebo|Given PO
16149720|NCT01783496|Device|Thermage CPT|Treatment with Thermage patterned, total, or framed tip
16149721|NCT01783483|Device|SternaLock Blue closure system|SternaLock Blue closure system is a primary closure system plate-based
16149722|NCT01783483|Device|Suture Wire|Closure system wire-based used to approximate the two halfs of the sternum following a median sternotomy.
16149723|NCT01783470|Drug|beta3-adrenergic receptor agonist|single dose. The subjects were randomized to receive placebo on one study day and active beta3-adrenergic receptor agonist on the other study day.
16149724|NCT01783457|Other|Control|Usual treatment: pharmacological treatment + regular sessions with their psychiatrist.
16149725|NCT01783457|Other|Individual psychoeducation|"Usual treatment + individual psychoeducational programme, consisting of 14 sessions of 60 minutes every other week for six months, focused on improving patient awareness of their condition, adherence to treatment, identification of prodromes, early intervention in potential relapses, anxiety management techniques, social skills, healthy lifestyle habits and problem solving.
~Programme of sessions available upon request."
16149726|NCT01783444|Drug|Capecitabine|Capecitabine, tablets for oral use, 1250 mg/m² twice daily for 2 weeks followed by one week rest (3-week-cycle) (locally supplied)
16149727|NCT01783444|Drug|Exemestane|Exemestane, tablets for oral use, 25 mg per day in (locally supplied)
16149728|NCT01783444|Drug|Everolimus|Everolimus, 5 mg tablets for oral use, 10 mg (2 x 5 mg) per day (centrally supplied)
16149729|NCT01783431|Drug|Poly ICLC|Poly-ICLC is considered an investigational drug and has not been approved by the Food and Drug Administration (FDA) for treatment of your disease. It is currently being tested in clinical trials for brain tumors, lymphoma, human immunodeficiency virus (HIV) and prostate cancer. It is thought that Poly-ICLC, when used with dendritic cells as a vaccine therapy, may work to help the immune system fight disease.
16149730|NCT01783431|Procedure|leukapheresis|Leukapheresis is a process in which white blood cells are collected from the body. These cells will be given together with Poly-ICLC therapy when subjects begin study treatment.
16149731|NCT01783418|Behavioral|Mindfulness Intervention|Mindfulness-based intervention adapted for teenagers
16149732|NCT01783392|Procedure|Transcutaneous Electrical Nerve Stimulation|
16149733|NCT01783379|Drug|micafungin|100mg/day infusion in 1 hour
16149734|NCT01783366|Device|TUBE EXCHANGER|
16149735|NCT01783353|Dietary Supplement|Zinc gluconate|
16149736|NCT01783353|Dietary Supplement|Corn starch pill|
16149737|NCT01783340|Drug|Azithromycin capsules|Azithromycin capsules will be administered at each immunization
16149738|NCT01783340|Drug|Placebo|Placebo capsules will be administered at each immunization
16149739|NCT01783340|Biological|Immunization with falciparum|three inoculations with 5 infected mosquito bites
16149740|NCT01783327|Behavioral|Teens-Connect|Teens-Connect combines Managing Diabetes and TEENCOPE. Managing Diabetes consists of 5 sessions on age-appropriate, educational content related to diabetes problem-solving and self-efficacy to improve self-management. TEENCOPE consists of 5 sessions designed to increase youth's sense of competence and mastery by retraining inappropriate or non-constructive coping styles and forming more positive styles and patterns of behavior. The program is highly interactive and youth can talk with each other on an online moderated discussion board. Youth will be asked to use the website at least twice per week for 4 weeks.
16149823|NCT01782755|Other|Placebo - Microcrystalline Cellulose|Placebo capsule, twice daily (containing Microcrystalline Cellulose)
16149741|NCT01783327|Behavioral|Planet D|Planet D provides age-appropriate diabetes education on a variety of topics and social networking discussion boards on diabetes, food and exercise, personal interests, and diabetes camp. Planet D addresses emotions and self-management through education and social networking. Youth who register can also create a profile, upload and share pictures, identify favorite news and blog feeds as well as provide comments or tags to other members. Planet D has been online since 2007 and contains numerous diabetes-related articles geared toward youth as well as a secure message board. Youth will be asked to interact with the website twice a week for 4 weeks.
16149742|NCT01783314|Procedure|MRI of liver|MRI of liver with intravenous gadoxetate disodium
16149743|NCT01783301|Drug|FSH|
16149744|NCT01783288|Other|Autonomic Function Testing|"heart rate and blood pressure will be continuously monitored while participants undergo a variety of breathing techniques (deep breathing, rapid breathing, blowing against resistance) and during sustained handgrip and cold pressor (hand in ice water). All tests are meant to stimulate the autonomic nervous system to produce changes in blood pressure and heart rate of short duration that reflect how well the autonomic nervous system is functioning.
~Also during autonomic function testing, cardiac output will be measured to analyze the shift of fluids in the body (body impedance) and / or by analyzing the air that is breathed."
16149745|NCT01783288|Other|Posture Study|Blood pressure, heart rate and blood samples (for catecholamines and hormones) will be measured & collected in the supine (lying) and upright position for each participant.
16149746|NCT01783288|Procedure|Measurement of Total Blood Volume|Total blood volume is measured by using iodinated I-131 tagged human serum albumin.
16149747|NCT01783288|Other|Exercise Capacity Test|Participants will ride on a stationary recumbent bicycle and the resistance will be gradually increased while expired air is measured.
16149748|NCT01783275|Behavioral|Aerobic exercise|12 weeks of aerobic exercise with weight maintenance
16149749|NCT01783262|Device|Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK|an energy level of 0.09 mJ/mm2, 2400 pulses once a week for 4 weeks.
16149750|NCT01783262|Device|Device: Sham extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK|
16149751|NCT01783249|Other|Stationary Exercise cycling|Stationary exercise cycling
16149752|NCT01783236|Drug|IV Acetaminophen|1000mg IV Ofirmev given every six hours for a total of four doses.
16149753|NCT01783236|Drug|Saline Placebo|Normal saline placebo given every six hours for a total of four doses if randomized to the placebo arm.
16149754|NCT01783210|Behavioral|Specific Therapeutic Lifestyle Changes program in pregnancy|"TLC Program includes diet and mild physical activity. The TLC comprises 1500 kcal/day (3 main meals and 3 snacks) composed of 55% carbohydrate, 20% protein, and 25% fat. The dietitian adds an 200 kcal/day for obese or 300 kcal/day for overweight. The exercise intervention is focused on increasing walking. All participants are advised to participate in 30 min of moderate intensity activity at least 3 days a week. Subjects wear a pedometer waist during walking session for the assessment of the adherence to the physical activity program. Women are told to consider using the talk test (being able to maintain a conversation during activity) to monitor exercise intensity, and to record the frequency and duration of the activity on a diary . Follow-up is performed at 16, 20, 28, 36 weeks."
16149755|NCT01783210|Behavioral|Dietary and behavioral counselling in pregnancy|"The Control group receives only a simple nutritional booklet about a lifestyle and healthy diet during pregnancy without explicit caloric restriction, in accordance with Italian Guidelines for a healthy diet during pregnancy, compatible with a recommended nutritional intake.
~30 minutes counseling session about the appropriate gestational weight gain (GWG) at term for each different BMI category is performed. Moreover, the importance of the limited GWG for preventing unfavorable maternal-neonatal outcomes related to excessive weight gain is explained. Women are scheduled to have a follow-up at 16, 20, 28, 36 weeks."
16149756|NCT01783197|Drug|Paclitaxel|
16149757|NCT01783197|Drug|Carboplatin|
16149758|NCT01783197|Drug|Selumetinib|
16149759|NCT01783197|Drug|Pemetrexed|
16149760|NCT01783197|Drug|Cisplatin|
16149761|NCT01783171|Drug|Akt Inhibitor MK2206|Given PO
16149762|NCT01783171|Drug|Dinaciclib|Given IV
16149763|NCT01783171|Other|Laboratory Biomarker Analysis|Correlative studies
16149764|NCT01783171|Other|Pharmacological Study|Correlative studies
16149765|NCT01783158|Procedure|Esophagoscopy and chromoendoscopy|"Esophagoscopy - examination of the interior of the esophagus by means of an esophagoscope.
~Chromoendoscopy - a method, which involves the topical application of stains or pigments to improve tissue localization, characterization, or diagnosis during endoscopy."
16149766|NCT01783132|Device|NIOX MINO|Active group (Budesonide) will be measuring exhaled NO at least 3 times/week at home to control their Asthma treatment via a algorithm schedule. The control group (Standard of care) will be measuring exhaled NO 4 times/year at study site.
16149767|NCT01783119|Dietary Supplement|Aloe Barbadensis Miller|
16149768|NCT01783119|Dietary Supplement|placebo water|
16149769|NCT01783106|Drug|Ciprofloxacin|experimental
16149770|NCT01783106|Drug|Doxycycline|experimental
16149771|NCT01783106|Drug|Hydroxychloroquine|oral
16149772|NCT01783106|Drug|Budesonide|active comparator
16149773|NCT01783093|Other|Data Collection|Collection of data from existing medical records
16149774|NCT01783080|Behavioral|Behavioral Activation for return to work|See Arm Description
16149775|NCT01783067|Other|Pearl millet|Participants in the control arm consume pearl millet which has not been biofortified. The intervention is consumed for two days.
16149776|NCT01783067|Other|Biofortified pearl millet|Participants in the experimental arm consume pearl millet biofortified with iron and zinc. The intervention is consumed for two days.
16149777|NCT01783054|Procedure|Surgery|Subjects will then receive surgery at MUSC within 4-8 weeks following completion of chemotherapy
16149778|NCT01783054|Genetic|Genetic Expression|Subjects will have genetic expression testing done on their tissue samples.
16149779|NCT01783054|Drug|Chemotherapy|Patients will receive gemcitabine at 1000 mg/m2 and abraxane at 125 mg/m2 intravenously on days 1, 8 and 15 of a 28 day cycle for 2 cycles
16149822|NCT01782755|Drug|L. rhamnosus GG - Probiotic|Twice daily, patients will receive either 1x1010 colony forming units (CFU) of L. rhamnosus GG (Culturelle, Locin Industries Ltd) in 1 capsule or an identical placebo capsule
16149866|NCT01782352|Drug|Omega-3 fatty acids (fish oil)|
16149780|NCT01783041|Drug|L-carnitine|Infants will receive L-carnitine 50 micromoles/kg/day, divided into three doses, intravenously for a minimum of 2 weeks or until they achieve enteral feeding volume of 100 cc/kg/day. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent dose of enteral L-carnitine will be given to the study patients.
16149781|NCT01783041|Drug|5% Dextrose|Infants will receive 5% dextrose (placebo) three times a day (volume equivalent to the experimental drug) intravenously for a minimum of 2 weeks or until they achieve enteral feeding volume of 100 cc/kg/day. If infant is receiving 100 cc/kg/day of enteral feeds before the supplementation endpoint, an equivalent volume of enteral placebo (5% Dextrose) will be given to the study patients.
16149782|NCT01783028|Behavioral|Community Health Worker support|For the intervention group, a trained Community Health Worker (CHW) provided education, support and service coordination through home visits. The CHW first made an in home assessment visit. At the assessment visit, the participant had the opportunity to ask questions and sign written consent. During this visit, the CHW assessed the participant's knowledge of asthma, current status of asthma control, challenges with controlling asthma, self-management practices and exposure to asthma triggers. After enrollment, the participant received up to four follow-up educational visits 0.5, 1.5, 3.5 and 7 months later. In addition to scheduled visits, the CHWs worked with their participants on an as-needed basis via telephone, email, or additional home visits.
16149783|NCT01783015|Drug|Etanercept|Etanercept 50 mg once-weekly
16149784|NCT01783015|Drug|Etanercept|Etanercept 50 mg once-weekly
16149785|NCT01783015|Drug|Placebo|Etanercept placebo once-weekly
16149786|NCT01783015|Drug|Placebo|Etanercept placebo once-weekly
16149787|NCT01783002|Radiation|11C-Methionine PET/CT scanning|PET with the radiopharmaceutical carbon-11 methionine (11C-MET) has been considered to improve diagnosis due to a superior spatial resolution and higher specificity compared to other radiotracers such as 18F-FDG. For the 11C-MET PET/CT, the patient will receive an intravenous bolus injection of 11C-MET as manufactured at the BCCA production facility at a dose of 6 (0.16 mCi) MBq per kilogram but not to exceed 555 MBq (15 mCi).
16149788|NCT01783002|Radiation|18F-FDG PET/CT scanning|For PET/CT scans, the patient will first receive an intravenous bolus injection of 18F-FDG as manufactured at the BCCA production facility in a dose determined by body weight but not to exceed 521 MBq (14.1 mCi). Our standard adult prescription (70kg adult) for 18F-FDG is 296 MBq (8.0 mCi). The target dose for body scans is increased by 59.2 MBq (1.6 mCi) for every 20 kg increase in body weight to a maximum target dose of 474 MBq (12.8 mCi).
16149789|NCT01783002|Radiation|SPECT-CT scanning|For the SPECT-CT scan, each injection of intravenous 99mTc-MIBI is dosed at a maximum of 20 mCi (740MBq), as per usual standard of care. The energy window of each scan is at 140 keV, consistent with the standard of SPEC-CT imaging techniques.
16149790|NCT01782989|Drug|ORACEA®|ORACEA® (40mg doxycycline) capsule daily for 24 months
16149791|NCT01782989|Drug|Placebo|Placebo capsule daily for 24 months
16149792|NCT01782976|Drug|Cilengitide|2000 mg by vein twice weekly of each 28 day cycle.
16149793|NCT01782976|Drug|Bevacizumab|10 mg/kg by vein on Days 1 and 15 of each 28 day cycle.
16149794|NCT01782976|Behavioral|Questionnaire|Completion of MD Anderson Symptom Inventory for Brain Tumors (MDASI-BT) at baseline, Day 1 of cycle 2, and at end of treatment visit. Questionnaire should take about 5 minutes to complete.
16149795|NCT01782963|Drug|Lenalidomide|
16149796|NCT01782963|Drug|Bortezomib|
16149797|NCT01782963|Drug|Dexamethasone|
16149798|NCT01782950|Drug|Rifampicin, Isoniazid, Ethambutol, Pyrazinamide|Rifampicin, Isoniazid, Ethambutol, Pyrazinamide: 3, 4 or 5 tablets daily for weight below 55kg, above 55kg or above 70kg respectively for first 2 months followed by Rifampicin, Isoniazid: 3, 4 or 5 tablets daily for patients' weight below 55kg, above 55kg or above 70kg respectively for 4 months
16149799|NCT01782937|Drug|KHK4827|140 mg (dosage may be increased to 210 mg in case of insufficient efficacy)
16149800|NCT01782924|Drug|KHK4827|
16149801|NCT01782911|Dietary Supplement|Resveratrol|The patients will take 2 g of resveratrol per day for 40 days.
16149802|NCT01782911|Dietary Supplement|Placebo pills|The patients will take placebo for 40 days.
16149803|NCT01782898|Drug|Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min|Esmolol administered at a rate of 0.5 mg/kg followed by an infusion of 5-15 mcg/kg/min
16149804|NCT01782898|Drug|Placebo Comparator: .9 normal saline|Placebo Comparator: Placebo .9 normal saline infused at the same rate (/mg/kg bolus followed by 5-15 mcg/kg/mn) as the Esmolol would be administered,
16149805|NCT01782885|Procedure|Intra-articular injection of PRP|Patients from this arm will receive 3 intra-articular knee injections of autologous platelet-rich plasma, one injection every two weeks (6 weeks total).
16149806|NCT01782885|Drug|Acetaminophen|Patients from this arm will receive a dosis of acetaminophen (500 mg/8 hours) while PRP treatment lasts (6 weeks total).
16149807|NCT01782872|Procedure|Interscalene Block (ISB) - 0.375% Ropivacaine + additives|Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline
16149808|NCT01782872|Procedure|Interscalene Block (ISB) - 0.2% Ropivacaine + additives|Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
16149809|NCT01782872|Procedure|Interscalene Block (ISB) - 0.1% Ropivacaine + additives|Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline
16149810|NCT01782872|Procedure|Interscalene Block (ISB) - Systemic Control|Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
16149811|NCT01782859|Drug|Prednisone|
16149812|NCT01782859|Drug|Hydrocortisone|
16149813|NCT01782859|Drug|Placebo (for Prednisone)|
16149814|NCT01782846|Drug|Ixprim®|
16149815|NCT01782846|Drug|Dafalgan-Codeine®|
16149816|NCT01782833|Other|This is Non-interventional study|
16149817|NCT01782807|Procedure|Salpingectomy or Fimbriectomy|
16149818|NCT01782794|Other|Data collection|Poll and questionnaire-based methodology completed by face-to-face interviews, with possible additional follow-up offered to households.
16149819|NCT01782781|Drug|ropivacaine, ketorelac and epinephrine|Active group
16149820|NCT01782781|Drug|Placebo|Placebo group
16149824|NCT01782742|Drug|Bexarotene|Subjects will be randomized 4:1 to receive 4 weeks of double blind treatment of either Bexarotene or Placebo
16149825|NCT01782742|Drug|Placebo|
16149826|NCT01782729|Drug|Tacrolimus|Tacrolimus ointment, 0.03 percent twice a day for pediatric population for 4 weeks or until 1 week after the affected areas defined for treatment at baseline are completely cleared, whichever is first.
16149827|NCT01782690|Drug|erlotinib|Study participants will receive erlotinib according to Summary of Product Characteristics (SmPC)
16149828|NCT01782690|Drug|gemcitabine|Study participants will receive gemcitabine according to Summary of Product Characteristics (SmPC)
16149829|NCT01782677|Procedure|Bilateral Surgical Resection of Carotid Bodies|
16149830|NCT01782664|Drug|100 mg GSK2586184|100 mg GSK2586184 to be taken twice daily with food (as tablets) for up to 84 days.
16149831|NCT01782664|Drug|200 mg GSK2586184|200 mg GSK2586184 to be taken twice daily with food (as tablets) for up to 84 days.
16149832|NCT01782664|Drug|400 mg GSK2586184|400 mg GSK2586184 to be taken twice daily with food (as tablets) for up to 84 days.
16149833|NCT01782664|Drug|Placebo|Placebo tablets to be taken twice daily with food for up to 84 days.
16149834|NCT01782651|Drug|Lapatinib plus capecitabine|Lapatinib plus capecitabine
16149835|NCT01782638|Behavioral|deep brain stimulation|
16149836|NCT01782625|Other|NO exercise at depth|Subjects will NOT exercise while at depth
16149837|NCT01782625|Other|exercise at depth|Subjects will exercise while at depth
16149838|NCT01782612|Procedure|Multimodal analgesic techniques|Postoperative pain was controlled for all patients routinely by intravenous sulfentanil patient-controlled analgesia (PICA) in combination with Parecoxib(40 mg, every 12 h). PICA was continued with sulfentanil (1.25 µg.h-1) and 1.25 µg sulfentanil bolus with a 8-min lockout time. Oral oxycodone 0.2 mg was administered necessarily.
16149839|NCT01782612|Procedure|Total uni-Hip Replacement|All subjects will undergo standard Total uni-Hip Replacement
16149840|NCT01782599|Other|Dual nicotine patch and electronic cigarette|
16149841|NCT01782573|Drug|Chlorhexidine gluconate|(i)a sterile washcloth was saturated with 60ml of chlorhexidine gluconate (4%) cleansing solution and generously applied to the predefined surgical site followed by vigorous scrubbing for 3 min. (ii) after being patted with a sterile towel, the standardized 3-step disinfection was performed (iii) the applied iodine-alcohol disinfectant contained 70 ml of ethyl alcohol and 10 g of povidone-iodine per 100 ml
16149842|NCT01782573|Drug|0.9% Sodium Chloride|(i)a sterile washcloth was saturated with 60ml of sodium chloride (0.9%) and generously applied to the predefined surgical site followed by vigorous scrubbing for 3 min. (ii) after being patted with a sterile towel, the standardized 3-step disinfection was performed (iii) the applied iodine-alcohol disinfectant contained 70 ml of ethyl alcohol and 10 g of povidone-iodine per 100 ml
16149843|NCT01782560|Drug|Omeprazole|Omeprazole (a proton-pump inhibitor) is the most common treatment given to infants with laryngomalacia, in the hope that this will reduce their symptoms. Although this is an effective anti-reflux medication in this population, its use is off-label, and like any medication has potential risks, particularly in very young children. Side effects that have been described include abdominal pain, diarrhea, constipation, and cough. Although omeprazole is usually a safe medication, we do not currently know if it provides any benefit in laryngomalacia.
16149844|NCT01782560|Drug|Placebo|
16149845|NCT01782547|Behavioral|Telehealth Intervention|Monthly videoconference with diabetes nurse educator; Monthly videoconference with social worker; Diabetes action plan;
16149846|NCT01782547|Other|Usual Care|Standard diabetes care- typically a visit with a diabetes health care provider every 3 months and referrals to a dietitian or mental health specialist as deemed appropriate; Study participation reminder cards twice per month
16149847|NCT01782521|Procedure|No primer|Primer not used when bonding orthodontic brackets
16149848|NCT01782508|Drug|imatinib|a selectively inhibits the KIT protein tyrosine
16149849|NCT01782508|Drug|Interferon|Interferon belongs to the large class of glycoproteins known as cytokines.
16149850|NCT01782495|Drug|ombitasvir/paritaprevir/ritonavir and dasabuvir|Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet
16149851|NCT01782495|Drug|ombitasvir/paritaprevir/ritonavir|Tablet; ombitasvir coformulated with paritaprevir and ritonavir
16149852|NCT01782495|Drug|ribavirin|tablet
16149853|NCT01782482|Device|Lotrafilcon B contact lens with color|Silicone hydrogel contact lens with color
16149854|NCT01782482|Device|Phemfilcon A contact lens with color|Hydrogel contact lens with color
16149855|NCT01782456|Other|Study Oral Nutritional Supplement|Supplement contains a new protein mix consisting of a blend of milk, soy, and pea protein.
16149856|NCT01782443|Drug|Ziv-aflibercept|
16149857|NCT01782430|Procedure|- standard oxygenation|
16149858|NCT01782417|Behavioral|patient and provider intervention|Patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management; primary care providers receive patient-specific osteoarthritis information and treatment recommendations at the point of clinical care.
16149859|NCT01782404|Device|Chlorhexidine|Bladder irrigation with chlorhexidine 0.2 mg/ml twice daily
16149860|NCT01782391|Device|Stimulation|
16149861|NCT01782391|Device|SHAM|no stimulation
16149862|NCT01782378|Device|Real LED Treatment|"PhotoMedex Helmet: 12 Pods, 4.5 x 4.8cm (21.6 cm2); 20 diodes; 830nm; Power Output (PO) 665.3 mW; Power Density (PD)/LED 30.8 mW/cm2; CW; Time/session 28m 10s*; Dose: Energy Density 26 J/cm2.
~MedX Device: 1 Cluster Head/ear, 2 inch diameter (22.48 cm2); 870nm; PO 90 mW; PD/LED 4 mW/cm2; CW; Time/session 4m; Energy Density 4 J/cm2; 2 Vielight Intranasal Devices: Red, 633nm diode; PO 6.5 mW; PD/LED 7.6 mW/cm2; CW; Time/session 25m; Energy Density 11.4 J/cm2 and NIR, 810nm diode; PO 6.5 mW; PD/LED 7.6 mW/cm2; Pulse frequency 10Hz; Duty Cycle 50%; Time/session 25m; Energy Density 11.4 J/cm2 Thor Photomedicine Helmet: 10 Pods, 6cm diameter (28.3 cm2); 35 diodes; Wavelength 850nm; PO 1050 mW; PD/LED 50 mW/cm2; CW; Time/session 23m, 24s; Energy Density 26 J/cm2 2 Placement sets: 1) midline, 6 cluster heads; 2) L&R side of head 12 cluster heads (14m, 5s, each set); 1) midline, 5 cluster heads; 2) L&R side of head 10 cluster heads (11m, 42s, each set) CW, Continuous Wave"
16149863|NCT01782378|Device|Sham LED Treatment|Intervention for Real and Sham are Identical, but sham has power output of 0, no photons emitted.
16149864|NCT01782365|Device|SHAM stimulation|no stimulation
16149865|NCT01782365|Device|0,75 Hz stimulation|
16149870|NCT01782339|Drug|Combination Chemotherapy|"4 cycles of: Day 1 Actinomycin D 1mg/m2, Paclitaxel 80mg/m2, Methotrexate Day 4 Oxaliplatin 100mg/m2 Pegfilgrastim 6mg Day 8* Paclitaxel 80mg/m2 Day 15 Paclitaxel 80mg/m2
~*Day 8 will be omitted for the first three patients treated in this study and will be given at the end of treatment in a fifth cycle where Paclitaxel 80mg/m2 will be administered on Days 1, 8, 15 and 22. Before adding the extra Paclitaxel 80mg/m2 dose on day 8 the safety data for these patients will be reviewed by a DMC.
~NB This 5th cycle for patients 1-3 has been included to ensure that the four 'missed doses of paclitaxel are not omitted from the patients treatment regimen. Cycles 1-4 are 21 days cycles; Cycle 5 (for the first three patients only) is a 28 day cycle."
16149871|NCT01782326|Drug|QVA149|QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept 1 SDDPI.
16149872|NCT01782326|Drug|Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS)|Salmeterol/fluticasone dry inhalation powder delivered via the Accuhaler device.
16149873|NCT01782313|Drug|tivozanib|Given PO
16149874|NCT01782313|Other|laboratory biomarker analysis|Correlative studies
16149875|NCT01782300|Biological|TV003 Vaccine|TV003 will contain an admixture of the following monovalent dengue vaccines: 10^3 PFU of rDEN1Δ30, 10^3 PFU of rDEN2/4Δ30(ME), 10^3 PFU of rDEN3Δ30/31-7164, and 10^3 PFU of rDEN4Δ30. TV003 vaccine will be administered by subcutaneous injection in participants' deltoid region of the upper arm.
16149876|NCT01782300|Biological|Placebo Vaccine|Placebo vaccine will be administered by subcutaneous injection in participants' deltoid region of the upper arm.
16149877|NCT01782287|Biological|Dendritic vaccine, allogeneic hematopoietic stem cells, cytotoxic lymphocytes|
16149878|NCT01782287|Biological|Dendritic vaccine, autologous hematopoietic stem cells, cytotoxic lymphocytes|
16149879|NCT01782274|Biological|Dendritic vaccine, allogeneic hematopoietic stem cells, cytotoxic lymphocytes|
16149880|NCT01782274|Biological|Dendritic vaccine, autologous hematopoietic stem cells, cytotoxic lymphocytes|
16149881|NCT01782261|Drug|Liraglutide|once daily subcutaneous injection
16149882|NCT01782261|Drug|Saxagliptin|once daily tablet
16149883|NCT01782248|Other|Questionnary and IRM|
16149884|NCT01782235|Drug|Tocilizumab|
16149885|NCT01782235|Drug|Placebo|
16149886|NCT01782222|Drug|Rotigotine|"Rotigotine, transdermal patches:
~10 cm^2 (2 mg / 24 hours); 20 cm^2 (4 mg / 24 hours); 30 cm^2 (6 mg / 24 hours); 40 cm^2 (8 mg / 24 hours)
~The maximum Rotigotine dose allowed is 8 mg / 24 hours or 16 mg / 24 hours for patients with advanced Parkinson's Disease and 6 mg / 24 hours or 8 mg / 24 hours for those with early Parkinson's Disease Duration: up to 21 weeks (including de-escalation)"
16149887|NCT01782222|Other|Placebo|"Placebo, matching transdermal patches
~Duration: up to 21 weeks (including de-escalation)"
16149888|NCT01782196|Device|Enhanced one piece drainable pouch with Type A mouldable adhesive|
16149889|NCT01782196|Device|Enhanced one piece drainable pouch with Type B mouldable adhesive|
16149890|NCT01782183|Device|Thermal camera by Flir -HM series.|The patient will be photographed twice by directing the camera externally to each tonsil from below the mandibular angle
16149891|NCT01782170|Drug|Iocide Oral Rinse|
16149892|NCT01782170|Drug|Placebo|
16149893|NCT01782144|Other|NutriSystem portion-controlled pre-packaged meals|
16149894|NCT01782131|Drug|Posaconazole|POS IV: Day 1: 300 mg BID Day 2-84: 300 mg QD POS oral: Day 1: 300 mg BID Day 2-84: 300 mg QD
16149895|NCT01782131|Drug|Voriconazole|VOR IV: Day 1: 6 mg/kg per body weight administered BID Day 2-84: 4 mg/kg per body weight administered BID VOR oral: Day 1: 300 mg BID Day 2-84: 200 mg BID
16149896|NCT01782131|Drug|Placebo|Matching placebo received for Posaconazole (IV and oral) or Voriconazole (oral)
16149897|NCT01782118|Dietary Supplement|Lactobacillus GG|
16149898|NCT01782105|Behavioral|Healthy lifestyle counseling|Nutritionnal and physical activity counseling and physical activity session group
16149899|NCT01782105|Behavioral|Control group|Evaluation of nutritional and physcial activity habits
16149900|NCT01782092|Other|Chiropractic Adjustment|Chiropractic adjustments will be administered using Activator Methods Basic protocol
16149901|NCT01782079|Dietary Supplement|L. brevis|
16149902|NCT01782066|Biological|MEN-ACYW135 reduced-dose intradermal administration|Modified traditional dose escalation rule (TER) in an adaptive design. The study will be performed in duplicate, with 2 vaccines.
16149903|NCT01782053|Behavioral|Picture warning|Warning contains picture proposed for each text statement by FDA
16149904|NCT01782053|Behavioral|Control|
16149905|NCT01782040|Other|Auriculotherapy group|It was used semipermanent needles (1.5mm) to stimulate points, once on a week, during 8 sessions.
16149906|NCT01782027|Drug|3H-cholesterol bound to albumin|up to 100 uCi of [3H]-cholesterol (containing approximately 0.2 mg of cholesterol) mixed with a solution containing human serum albumin will be administered as an intravenous bolus injection
16149907|NCT01782014|Procedure|colonoscopy|colonoscopy using different methods of insufflation
16149908|NCT01782001|Dietary Supplement|vitamin A|vitamin A with placebo
16149909|NCT01782001|Dietary Supplement|vitamin A and zinc|combination of vitamin A and zinc supplements
16149910|NCT01781988|Drug|carboplatin, gemcitabine , pametrexed|"A.individual therapy :enrolled patients with ERCC1 negative tumors who received carboplatin and a third-generation agent (gemcitabine or pametrexed) based on RRM1 or TS expression. If RRM1 protein was negatively expressed in the tumor tissues, gemcitabine was used, whereas pemetrexed was used if RRM1 was positively expressed and TS was negatively expressed.
~B.non-individualized therapy :enrolled patients who received carboplatin and a third-generation agent but were not based on ERCC1, RRM1, or TS expression."
16149911|NCT01781975|Drug|Imatinib Mesylate|
16149912|NCT01781975|Drug|Placebo (For imatinib mesylate)|
16149913|NCT01781962|Other|No Treatment|No Treatment was given in this study.
16149914|NCT01781949|Other|A: Nontargeted rapid HIV screening|Patients who present to the ED for evaluation, who meet criteria for inclusion, and who are randomized to this arm will be offered voluntary, free, and confidential rapid HIV testing by nurses using opt-out consent during medical screening.
16149954|NCT01781637|Drug|placebo|subcutaneous injection
16149955|NCT01781624|Other|Study Oral Nutritional Supplement|Supplement contains a new protein mix consisting of a blend of milk, soy, and pea protein.
16150274|NCT01778998|Procedure|SICS pre-cut|Small incision cataract surgery with pre-cut is done
16149915|NCT01781949|Other|B: Enhanced targeted rapid HIV screening|Patients who present to the ED for evaluation, who meet criteria for inclusion, and who are randomized to this arm will be asked questions from the Denver HIV Risk Score (DHRS). Patients will be considered at increased risk for HIV infection if they have a DHRS score of 30 or more. These increased-risk patients will be offered rapid HIV testing using opt-out consent by nurses during medical screening. Patients identified as low risk (DHRS <30) will not be offered rapid HIV testing but will eligible for diagnostic HIV testing.
16149916|NCT01781949|Other|C: Traditional targeted rapid HIV screening|Patients who present to the ED for evaluation, who meet criteria for inclusion, and who are randomized to this arm will be asked questions from a Behavioral Risk Screening Tool (BRST). The BRST was adopted from the 2001 Centers for Disease Control and Prevention's recommendations for targeted HIV screening, and includes 6 questions. An affirmative response to 1 or more questions identifies the person as being at increased risk for HIV infection. These patients will be offered rapid HIV testing using opt-out consent by nurses during medical screening. Patients who do not respond affirmatively to any of the questions will not be offered rapid HIV testing but will eligible for diagnostic HIV testing.
16149917|NCT01781936|Drug|Fluocinolone Acetonide|
16149918|NCT01781923|Behavioral|Cognitive remediation program|Subject plays for 30 minutes, 4 times per week, for 12 weeks.
16149919|NCT01781923|Behavioral|Small group social skills training|Meet once per week for duration of 40 weeks.
16149920|NCT01781910|Dietary Supplement|Branched Chain Amino Acid drink supplement|
16149921|NCT01781910|Dietary Supplement|Placebo|
16149922|NCT01781897|Device|acupuncture|sterile, disposable needles with a length of 40 mm and a diameter of 0.25 mm (Dongbang® Acupuncture Inc, Korea)
16149923|NCT01781897|Drug|mosapride|Mosapride Citrate tablet（5mg），Dainippon Sumitomo pharmaceutical Co.Ltd,Japan
16149924|NCT01781884|Drug|Gamma Aminobutyric Acid (GABA)|two dosages will be used in this study. GABA: 50mg/kg/day and 100mg/kg/day
16149925|NCT01781884|Drug|Placebo|
16149926|NCT01781871|Biological|Prevenar13|Prevenar13 0.5ml injected intramuscularly (im.) at day 1 and at 6 months after the transplantation.
16149927|NCT01781871|Biological|Pneumovax|0.5ml Pneumovax injected intramuscularly at day 1.
16149928|NCT01781845|Procedure|AFRI-SVI Ultrasound|This research scan uses acoustic radiation force impulse (ARFI) shear wave velocity imaging (SVI)a new ultrasound technology in which unique sound waves create the images/pictures of the kidney beng examined/scanned. This ultrasound scan will take approximately 10 minutes to complete.
16149929|NCT01781832|Device|ARFI-Derived Shear Wave Velocities|An ultrasound based scan uses ARFI, an acoustic radiation force impulse to estimate shear wave velocities during scanning of the urinary bladder. The research ultrasound scan lasts about 10 to 15 minutes.
16149930|NCT01781819|Procedure|ARFI SVI Ultrasound Imaging|Following a clinical renal ultrasound scan, the research scan using the ultrasound based acoustic radiation force impulse, or shear wave velocity imaging will be performed using standard approved ultrasound machines and transducers. This imaging will take approximately 5 to 10 minutes to complete.
16149931|NCT01781806|Drug|emtricitabine 200mg/tenofovir 300mg|The intervention medication will be tenofovir + emtricitabine, provided as a fixed-dose combination tablet as Truvada®. Dosing is 1 tablet by mouth once daily. For participants with a a confirmed (i.e. two consecutive) reduction in creatinine clearance (CrCl) to <50 mL/min, Truvada will be dose-reduced to 1 tablet by mouth every other day. For patients with CrCl <30 mL/min, Truvada will be discontinued.
16149932|NCT01781793|Other|Room air|Humidified room air (21% oxygen) will be inspired
16149933|NCT01781793|Other|Hyperoxia|60% oxygen will be inspired
16149934|NCT01781780|Behavioral|General Nutrition Recommendations|
16149935|NCT01781780|Behavioral|Breakfast Recommendation|
16149936|NCT01781780|Behavioral|No Breakfast Recommendation|
16149937|NCT01781754|Procedure|Blood withdrawal|This is the only intervention that is part of the study. A family physician or other physician will be responsible of the diabetic treatment (common treatment, e.g Metformin).
16149938|NCT01781741|Combination Product|therapeutic lymphadenectomy (TEMLA) and Stereotactic Body radiation therapy (SBRT)|Undergo TEMLA and SBRT
16149939|NCT01781741|Other|quality-of-life assessment|Ancillary studies
16149940|NCT01781728|Radiation|Stereotactic Body Radiation Therapy (SBRT)|SBRT 5 Gy x 5 (over 1-2 weeks)*
16149941|NCT01781728|Radiation|Stereotactic Body Radiation Therapy (SBRT)|SBRT 6.6 Gy x 5 (over 1-2 weeks)*
16149942|NCT01781715|Device|Zotarolimus-eluting coronary stent|Multivessel stenting or Staged PCI with Zotarolimus-eluting coronary stent in STEMI patients
16149943|NCT01781702|Drug|Pelubiprofen 30 mg|
16149944|NCT01781702|Drug|Celebrex 200 mg|
16149945|NCT01781689|Procedure|Functional Electric Stimulation|apply to the hemiplegia affected limbs, helping movement
16149946|NCT01781689|Other|Rehabilitation programs|include occupational therapy and physical therapy
16149947|NCT01781663|Device|KAM2904 Face Cream|
16149948|NCT01781663|Device|KAM3008 Body Lotion|
16149949|NCT01781663|Other|petrolatum-based moisturizer|
16149950|NCT01781650|Other|Air Insufflation method.|Colonoscopy will be performed in the standard fashion, with the minimal air insufflation required to aid insertion and allowing for washing as needed. Considered to be standard procedure.
16149951|NCT01781650|Other|Water Immersion method.|Air will not be insufflated until the cecum is reached. It will be allowed only 3 times and no more than 10 seconds each time (ITT failure if >3) if the lumen cannot be seen. Infusion of water during the insertion phase of colonoscopy mainly to open the colonic lumen and progress to the cecum immersed in the water environment thus created, without attempting to clear the colon contents. Residual air in the colon will not be removed. Infused water and residual feces will be suctioned back predominantly during withdrawal.
16149952|NCT01781650|Other|Water Exchange method.|Air will not be insufflated until the cecum is reached. Infusion of a sufficient amount of water to render the lumen of the colon a slit to progress with the colonoscope. Part of the infused water will be constantly suctioned back exchanging clean for dirty or hazy water. Suction of water will also be applied when colonoscope insertion proceeds smoothly. Air pockets will be always aspirated to collapse the lumen. After cecal intubation as much residual water as possible will be aspirated before beginning the withdrawal phase. During withdrawal residual water and feces will be suctioned.
16149953|NCT01781637|Drug|Omalizumab|subcutaneous injection
16150267|NCT01779050|Drug|Fluorouracil|
16149956|NCT01781611|Drug|extended release dipyridamole 200mg/aspirin 25mg|one tablet twice daily for 24 weeks
16149957|NCT01781611|Drug|81mg aspirin|half a tablet twice daily for 24 weeks
16149958|NCT01781598|Device|Total knee arthroplasty (TKA) (Smith &Nephew®)|
16149959|NCT01781585|Procedure|hemodialysis|Patients were randomized to receive CVVH or SLED and the next day on the other.
16149960|NCT01781572|Drug|LEE011|LEE011 will be administered orally once daily
16149961|NCT01781572|Drug|MEK162|MEK162 will be administered orally twice daily
16149962|NCT01781559|Dietary Supplement|phenolic acid|phenolic acid
16149963|NCT01781546|Procedure|drug-eluting balloon (DEB)|The length of the DEB is chosen so that the lesion and 2mm from both ends are covered by the DEB. If needed, several DEBs can be used to cover the whole lesion. The diameter of the DEB and the pressure used is chosen so that the balloon-artery -ratio is 0.8-1.0. In case of a flow limiting dissection, significant recoil or coronary perforation, a provisional BMS is implanted (stent-artery -ratio 1.1) and the post dilatation is performed if indicated (the lesion length is >20mm or stent malapposition is suspected).
16149964|NCT01781546|Procedure|bare-metal stent (BMS)|The BMS is implanted after predilatation (stent-artery -ratio 1.1) to cover the whole lesion and the postdilatation is performed if indicated (the lesion length >20mm or stent malapposition is suspected).
16149965|NCT01781533|Procedure|algorithm|
16149966|NCT01781520|Biological|DC-CIK Treatment|The DC-CIK cells were infused on days 15, 17, and 19 of 21-day cycles.
16149967|NCT01781520|Drug|S1|The dose of S-1 is determined according to the body surface area as follows: <1.25 m2, 40 mg; 1.25-<1.5 m2, 50 mg; and >1.5 m2, 60 mg, given twice daily after meals for 14 days followed by a 7-day rest. Cycles is repeated every 21 days. Treatment is continued until disease progression, unacceptable toxic effects, or the withdrawal of consent.
16149968|NCT01781520|Other|Best supportive care|Best supportive care
16149969|NCT01781507|Drug|Cetirizine|Cetirizine is an antihistamine currently indicated for allergic rhinitis
16149970|NCT01781507|Drug|Placebo|This placebo ( sugar pill) will provide the negative control for this study
16149971|NCT01781494|Procedure|Immobilization followed by protected range of motion|
16149972|NCT01781494|Procedure|Immediate range of motion|
16149973|NCT01781468|Drug|armodafinil 150 mg|given orally
16149974|NCT01781468|Other|Placebo|given orally
16149975|NCT01781468|Drug|armodafinil 250 mg|given orally
16149976|NCT01781455|Drug|BBI503|
16149977|NCT01781442|Drug|Temsirolimus|"The recommended dose of Torisel is 25 mg infused over a 30-60 minute period once a week.
~Treatment will continue until disease progression or unacceptable toxicity.
~The use and dosage recommendations for Torisel will take place on the basis of the approved local product document and will be adjusted solely according to medical and therapeutic necessity."
16149978|NCT01781429|Drug|BVD-523|Oral, multiple escalating doses, twice daily, for 21 days in each treatment cycle
16149979|NCT01781403|Drug|Temozolomide|Preoperative chemoradiotherapy with fixed dose of capecitabine and temozolomide, the dose of temozolomide will be escalated for finding MTD and RD.
16149980|NCT01781390|Biological|12.5 M Mesenchymal Precursor Cells (MPC)|MPCs
16149981|NCT01781390|Other|Placebo|Placebo
16149982|NCT01781390|Biological|25M Mesenchymal Precursor Cells (MPC)|MPC
16149983|NCT01781377|Drug|PROPOFOL|PROPOFOL FOR NAUSEA AND VOMITING PROPHYLAXIS
16149984|NCT01781377|Drug|METOCLOPRAMIDE|METOCLOPRAMIDE FOR NAUSEA AND VOMITING PROPHYLAXIS
16149985|NCT01781377|Drug|PLACEBO|SALINE INFUSION
16149986|NCT01781364|Behavioral|Brain Fitness Training, Posit Science SF|Computer aided cognitive training based on principles of neuroplasticity
16149987|NCT01781351|Other|Taping the ankle|
16149988|NCT01781338|Other|Induction therapy|The intervention is dependent on the respective sub-protocol and can include either endocrine therapy, neoadjuvant chemotherapy or targeted therapy.
16149989|NCT01781325|Device|IBEHR|physical therapy device to educate patients in physical therapy exercise performance
16149990|NCT01781312|Dietary Supplement|ProTectis|
16149991|NCT01781312|Dietary Supplement|Gastrus|
16149992|NCT01781299|Device|AlloDerm RTU|
16149993|NCT01781299|Device|SurgiMend PRS|
16149994|NCT01781286|Behavioral|High Protein|250 kcal; 40% Protein; 40% Carbohydrate; 20% Fat
16149995|NCT01781286|Behavioral|Low Protein|5% Protein; 50% Carbohydrates; 45% Fat
16149996|NCT01781273|Other|Ethanol|During a 45 min period, investigators will ask participants to drink 500ml of cranberry juice, 100 ml at a time each 5 minutes. Depending of the allocation, these drinks will contain more or less alcohol. Pure ethanol will be used mixed with the beverage. The amount of alcohol to dilute in the drink will be calculated using Widmarks formula. Participants will move to the simulator room 20 minutes after having finished drinking the first 500 ml. To maintain the BAC level, investigators will use a breathalyser and provide 100 ml cranberry juice every 20 minutes with the amount of necessary alcohol. The person administrating drinks will hand over the drinks and make sure the participants breaths in before taking a sip, thereby inhaling alcohol vapour from the lid and keeping them blinded to the content.
16149997|NCT01781273|Other|Cranberry juice|100 mL cranberry juice is provided in a 250 ml container.
16149998|NCT01781247|Behavioral|Minimal behavioral intervention|The minimal behavioral intervention consists of one single counseling session of 45 minutes that targets specific MI-triggered traumatic reactions. The focus of the intervention is an educational and resource-oriented approach targeting individual patient resources and cognitive (re)structuring.
16149999|NCT01781247|Behavioral|Control intervention|"The control intervention consists of one single counseling session of 45 minutes that targets more general information about the role of psychological stress in coronary heart disease. Any terminology related to trauma will be completely avoided."
16150000|NCT01781234|Drug|Intranasal Insulin|
16150001|NCT01781234|Drug|Placebo|
16150002|NCT01781221|Device|Alpha-Bio's GRAFT Natural Bovine Bone|
16150003|NCT01781221|Device|Bio-Oss xenograft|
16150004|NCT01781208|Device|Ultrasound-Based Acoustic Radiation Force Impulse (ARFI)|Research scans using ultrasound-based acoustic radiation force impulse (ARFI) will image the liver non-invasively.
16150268|NCT01779024|Drug|Ghrelin|
16150269|NCT01779024|Drug|Placebo|
16150270|NCT01779024|Procedure|fMRI|
16150005|NCT01781169|Dietary Supplement|Oral supplementation of vitamin D|Weekly oral supplementation of 50,000 IU vitamin D (cholecalciferol) for eight weeks to the obese males compared with the normal-weight males. The chemical form of vitamin D is cholecalciferol capsuled as fine powder.
16150006|NCT01781143|Device|Perform Echo at home.|A group of women that follows an IVF treatment, will perform their echoes at home, instead of always make an appointment in the clinic.
16150007|NCT01781130|Procedure|Steroid injection|
16150008|NCT01781117|Procedure|Holmium Laser Enucleation of the Prostate (HoLEP)|Enucleation of the enlarged nodule of prostate and morcellation of the resected tissue.
16150009|NCT01781117|Device|Holmium laser enucleation system and morcellator|Holmium laser enucleation and morcellation
16150010|NCT01781104|Drug|RM-131|Double blind RM-131 (100 ug) will be delivered subcutaneously once daily for 14 days.
16150011|NCT01781104|Drug|Placebo|Placebo delivered subcutaneously once daily for 14 days.
16150012|NCT01781091|Device|INTELLIVENT ASV FULLY CLOSED-LOOP VENTILATION|
16150013|NCT01781091|Device|Conventionals Modes|
16150014|NCT01781078|Radiation|MRI|The study-specified MRI scan includes RF- and gradient-intensive sequences designed to test the ImageReady System in the MR environment
16150015|NCT01781078|Device|ImageReady System implant|Pacemaker and lead(s) implant
16150016|NCT01781065|Device|transcranial direct current stimulation|
16150017|NCT01781052|Drug|Ventavis (Iloprost, BAYQ6256)|Initial dose: 2.5 µg per inhalation session; 6-9 inhalations/day. Dose can be increased to up to 5.0 µg per inhalation session.
16150018|NCT01781039|Device|Hearing Aid fitting|Subjects with hfPTAs ranging from 0-55 dB HL will be recruitedwith 100 persons self-reporting difficulty HIN (> 50% of the time), and 100 persons reporting little difficulty HIN (< 50% of the time) will be randomly assigned to one of five groups (n = 200) based on enabled HA features using an online random assignment tool. Unaided HIQ and HIN assessments will be conducted in the sound field, and baseline DPOAE and CAP assessments will be measured. Subjects will be fit with binaural premium level receiver-in-the canal HAs (Phonak B90 or equivalent model at the start of the study) with 56 dB SPL gain receivers, using closed domes, and programmed to NAL-NL2 target gain, and randomly assigned to the groups.
16150019|NCT01781026|Drug|Vemurafenib|Single arm trial
16150020|NCT01781013|Other|Technology-supported care|The depression care-management technology that will interact with patients is the Automated Speech Recognition (ASR) for remote monitoring data collection. The ASR will use automated telephone calls to reach out to patients to repeat depression screening using PHQ-9, triggered either by calendar date or upcoming appointments, and to remind patients of their appointments in pre-determined time. In addition, the ASR will apply a structured script to conduct automatic follow-up with patients regarding their depression treatment adherence and side effects in order to provide data to help primary medical providers promptly and optimally adapt treatment. The ASR script will also include structured relapse prevention prompts. For providers and administrators, the depression care-management technology aimed to improve their workflow regarding depression care is Enhanced Disease Registry (EDR)..
16150021|NCT01781000|Behavioral|Brain Fitness & Brain Training- Posit Science|Computer aided cognitive program designed for intensive training of auditory perception, memory and attention
16150022|NCT01781000|Behavioral|Facial Affect Training- FAT|Computer-aided cognitive program designed for intensive training of facial affect discrimination, memory and attention
16150023|NCT01781000|Behavioral|Treatment as usual|standard treatment protocol of schizophrenia ward
16150024|NCT01780987|Drug|Apixaban|10 mg BID for 7 days followed by 5 mg BID for 23 weeks (total 24 weeks)
16150025|NCT01780987|Drug|Unfractionated Heparin (UFH)|Dosing adjustment based on APTT = 1.5-2.5 times the control value, and until INR ≥ 1.5 for 5 days or more
16150026|NCT01780987|Drug|Warfarin|Dosing for 24 weeks to target INR range between 1.5-2.5
16150027|NCT01780974|Drug|Lipoic Acid plus Omega-3 Fatty Acids|alpha lipoic acid (racemic) and fish oil concentrate
16150028|NCT01780974|Drug|Placebo|placebo capsules
16150029|NCT01780948|Drug|Atorvastatin 20 mg|Add atorvastatin 20 mg and compare 12-hour AUC of everolimus between Arm everolimus and everolimus with atorvastatin 20 mg
16150030|NCT01780948|Drug|Everolimus|Administration only everolimus, no atorvastatin. Everolimus administration with adjusted dose to target C trough (C0)level between 3-12 ng/mL.
16150031|NCT01780935|Drug|Ranibizumab|Intravitreal injections of 0.5 mg Ranibizumab
16150032|NCT01780922|Other|Low Calorie Cranberry Juice Cocktail|Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes
16150033|NCT01780922|Other|Cranberry Extract Beverage|Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes
16150034|NCT01780922|Other|Non-Cranberry Beverage|Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes
16150035|NCT01780909|Drug|Paromomycin Sulfate Fasted State|
16150036|NCT01780909|Drug|Paromomycin Sulfate Fed State|
16150037|NCT01780909|Drug|Paromomycin Sulfate w/ domperidone|
16150038|NCT01780909|Drug|Paromomycin Sulfate w/ loperamide HCl|
16150039|NCT01780883|Drug|melatonin|
16150040|NCT01780883|Drug|Placebo|Placebo tablets of Circadin®
16150041|NCT01780870|Dietary Supplement|Weight loss group (Full meal replacement products)|In the intervention arm of this non randomized, open label study to assess the effects of weight loss on insulin sensitivity and leptin tolerance subjects will use full meal replacement products (1280-1320kcal/day). Subjects will be on the full meal replacement products only, for the first 12 weeks, between 13 to 19 weeks they will be transitioned to regular food, from 19 weeks and going forward they will be on chronic maintenance phase
16150042|NCT01780844|Drug|ASKP1240|intravenous infusion
16150043|NCT01780844|Drug|Tacrolimus|intravenous or oral
16150044|NCT01780844|Drug|Mycophenolate Mofetil (MMF)|intravenous or oral
16150045|NCT01780844|Drug|Basiliximab|intravenous
16150046|NCT01780844|Drug|Methylprednisone|Intravenous
16150047|NCT01780844|Drug|Prednisone|Oral
16150048|NCT01780831|Drug|Raltegravir|RAL was given as oral granules for suspension.
16150049|NCT01780818|Other|Air Insufflation method.|Colonoscopy will be performed in the standard fashion, with the minimal air insufflation required to aid insertion and allowing for washing as needed. Considered to be standard procedure.
16150271|NCT01779024|Drug|Alcohol|
16150050|NCT01780818|Other|Water Immersion method.|Air will not be insufflated until the cecum is reached. It will be allowed only 3 times and no more than 10 seconds each time (ITT failure if >3) if the lumen cannot be seen. Infusion of water during the insertion phase of colonoscopy mainly to open the colonic lumen and progress to the cecum immersed in the water environment thus created, without attempting to clear the colon contents. Residual air in the colon will not be removed. Infused water and residual feces will be suctioned back predominantly during withdrawal.
16150051|NCT01780818|Other|Water Exchange method.|Air will not be insufflated until the cecum is reached. Infusion of a sufficient amount of water to render the lumen of the colon a slit to progress with the colonoscope. Part of the infused water will be constantly suctioned back exchanging clean for dirty or hazy water. Suction of water will also be applied when colonoscope insertion proceeds smoothly. Air pockets will be always aspirated to collapse the lumen. After cecal intubation as much residual water as possible will be aspirated before beginning the withdrawal phase. During withdrawal residual water and feces will be suctioned.
16150052|NCT01780792|Other|Dance Dance Revolution video game play|Individuals play dance dance revolution 3 times a week for 8 weeks
16150053|NCT01780779|Other|MRI|"MRI exam will be performed in all patients included in the study. The patients will be treated by chemotherapy, defined in the EURO-EWING or EURAMOS protocol.
~The MR findings will not have any impact on the treatment."
16150054|NCT01780753|Drug|Primaquine|Primaquine GPO® (Government Pharmaceutical Organization, Thailand) 0.5 mg/kg will be given once daily for 14 days.
16150055|NCT01780740|Drug|Atorvastatin|Atorvastatin (80 mg od) started not earlier than 6 days before surgery and continued until the 5th post-operative day included;
16150056|NCT01780740|Drug|Placebo|Placebo started not earlier than 6 days before surgery and continued until the 5th post-operative day included;
16150057|NCT01780727|Procedure|EGHEM|Echocardiography guided hemodynamic management. Subjects in this arm will undergo intraoperative transesophageal echocardiography as part of the study.
16150058|NCT01780714|Other|Conventional cigarettes (CC)|Subjects are randomized in a 1:1 fashion to be assigned either A) continuing CC, or B) switching to THS 2.1
16150059|NCT01780714|Other|THS 2.1|Subjects are randomized in a 1:1 fashion to be assigned either A) continuing CC, or B) switching to THS 2.1
16150060|NCT01780701|Procedure|Magnetic Resonance Spectroscopy Imaging with rectal probe|
16150061|NCT01780688|Other|Conventional cigarettes (CC)|Subjects are randomized in a 1:1 fashion to be assigned to one of the 2 sequences, either A) CC and then THS 2.1, or B) THS 2.1 and then CC.
16150062|NCT01780688|Other|THS 2.1|Subjects are randomized in a 1:1 fashion to be assigned in one of the sequences, either A) CC and then THS 2.1, or B) THS 2.1 and then CC
16150063|NCT01780675|Radiation|Radiation Prophylactic Cranial Irradiation|
16150064|NCT01780675|Radiation|Radiation Hippocampal Avoidance PCI|
16150067|NCT01780649|Procedure|IMSI|Intracytoplasmic Morphologically Selected Sperm Injection (IMSI) is a modification of IntraCytoplasmic Sperm Injection (ICSI) with a choice of the spermatozoon to be injected done at a 6000x magnification instead of 400x commonly used in ICSI
16150068|NCT01780649|Procedure|ICSI|ICSI is largely choice of the spermatozoon to be injected done at a 400x magnification
16150069|NCT01780636|Drug|botulinum toxin|
16150070|NCT01780623|Device|Bright white light|
16150071|NCT01780623|Device|Dim red light|
16150072|NCT01780610|Drug|Letrozole and human chorionic gonadotrophin|the follicular development is supported by Letrozole(LE) 2.5mg,once daily is introduced on cycle day 3 .And on cycle day 10 , a Vagina ultrasound is introduced to monitor the development of the follicular ,following by intramuscular gonadotrophin 37.5~75 IU/d until there is a Luteinizing Hormone(LH) surge or ovulation .On the day appearing Luteinizing Hormone surge，patients is always introduced intramuscular human chorionic gonadotrophin(HCG) 10000 IU.If there is sill no Luteinizing Hormone surge when the follicle is 20-24mm ,the ovulation will be induced by HCG.Then the luteum was supported by HCG 2000-2500 IU/3d.Transfer of thawed embryos will be performed 3 days after ovulation is observed.
16150073|NCT01780610|Drug|estradiol and progesterone|oral estradiol, 2 mg, once daily, was introduced on cycle day 3 with an increasing doses protocol. If the endometrial thickness was greater than 7mm, progesterone 40-60 mg in oil was administered via intramuscular injection. Transfer of thawed embryos was performed 3 days later
16150074|NCT01780584|Drug|Oral T3 Low dose|Comparison of different dosages of drug. Low dose group oral T3 is 0.5 mcg/kg q24h
16150075|NCT01780584|Drug|Placebo|Comparison of different dosages of drug. In low dose group, placebo was given alternately with oral T3 every 12h with a total 3 doses for placebo and 3 doses for oral T3
16150076|NCT01780584|Drug|Oral T3 high dose|Comparison of different dosages of drugs. Oral T3 high dose is 0.5 mcg/kg q12h
16150077|NCT01780571|Procedure|CPAP 5 cm H2O + PSV 5 cm H2O|Patients in the intervention group received Continuous Positive Airway Pressure (5 cm H2O) and Pressure Supported Ventilation (5 cm H2O)
16150078|NCT01780558|Other|natural cycles|the ovulation is monitored spontaneously or induced by HCG when the dominant follicle is larger than 18mm without LH surge. Transfer of thawed embryos will be performed 4 days after LH surge/HCG administration or 3 days after ovulation is observed.
16150079|NCT01780558|Drug|estradiol and progesterone|oral estradiol, 2 mg, once daily, is introduced on cycle day 3 with an increasing doses protocol. If the endometrial thickness is greater than 7mm, progesterone 40-60 mg in oil will be administered via intramuscular injection. Transfer of thawed embryos will be performed 3 days later.
16150080|NCT01780545|Drug|OGX-427|"Three doses of 600 mg OGX-427 will be administered IV during the loading dose period (days -9 to -1). Following completion of the loading dose period, 600 mg OGX-427 will be given IV weekly on days 1, 8, and 15 of each 21-day cycle. OGX-427 must be administered prior to docetaxel on day 1 of each cycle.
~Following completion of 10 cycles of docetaxel, 600 mg OGX-427 will continue to be administered by IV weekly as maintenance therapy in Arm A participants who do not have disease progression (i.e., stable disease or better). Participants without documented disease progression who have discontinued from study treatment not due to toxicity related to OGX-427 can also continue to receive OGX-427 maintenance as long as they have completed disease assessments following at least 2 cycles of chemotherapy. Maintenance with OGX-427 will continue until disease progression or unacceptable toxicity."
16150272|NCT01778998|Procedure|MICS-group|Micro incision cataract surgery is done
16150081|NCT01780545|Drug|Docetaxel|"For Arm A Only: Docetaxel should be administered immediately following the completion of the OGX-427 infusion.
~For Both Arms: Docetaxel (75 mg/M2) will be administered IV on Day 1 of each 21 day cycle for a maximum of 10 cycles."
16150082|NCT01780532|Procedure|Photoacoustic Imaging (PAI)|Standard of Care
16150083|NCT01780519|Drug|lorazepam|single dose of 1 mg lorazepam
16150084|NCT01780506|Drug|E/C/F/TAF|150/150/200/10 mg FDC tablet administered orally once daily
16150085|NCT01780506|Drug|E/C/F/TDF|150/150/200/300 mg FDC tablet administered orally once daily
16150086|NCT01780506|Drug|E/C/F/TDF Placebo|Tablet administered orally once daily
16150087|NCT01780506|Drug|E/C/F/TAF Placebo|Tablet administered orally once daily
16150088|NCT01780493|Procedure|The Direct Nipple Ureteroneocystostomy Technique|
16150089|NCT01780480|Drug|Dynamic Chinese herbal granule formula|After evaluated the style of the syndrome (Zhenghou) by an experienced integrative medicine doctor, the patients should be given a Chinese herbal granule formula twice a day for 4 weeks, which should be selected from 10 kinds of Chinese herbal granules and weekly changed according to differentiation of syndromes (Zhenghou) of patients.
16150090|NCT01780480|Drug|Placebo|The 10 kinds of matched placebo granules were of the similar appearance, taste, smell with the corresponding Chinese herbal granules respectively. The interventional process of the placebo group is similar as the Chinese herbal granule formula group
16150091|NCT01780480|Procedure|Standard medical care|Standard medical care is the basic treatment for all enrolled patients, including aspirin 75-100mg per day, standard rehabilitation training, treatment for their primary diseases, etc.
16150092|NCT01780467|Behavioral|Role of dopamine|
16150093|NCT01780454|Drug|MEDI-507|T-Cell Depleting Agent
16150094|NCT01780454|Drug|Rituximab|B-Cell Depleting Agent
16150095|NCT01780454|Radiation|Total Body Irradiation|Bone Marrow Depletion
16150096|NCT01780454|Radiation|Thymic Irradiation|
16150097|NCT01780428|Drug|CL-108 (hydrodocone 7.5 mg, acetaminophen 325 mg, promethazine 12.5 mg)|
16150098|NCT01780428|Drug|Placebo|
16150099|NCT01780415|Other|blastocoele aspiration|
16150100|NCT01780402|Behavioral|Hand feeding techniques|"Direct hand feeding technique: When the feeding assistant holds the object (e.g., fork, spoon, cup) intended to provide food or fluids to the PWD without any active involvement on the part of the PWD.
~Hand-over-hand feeding technique: Occurs when the PWD is holding the object (e.g., fork, spoon, cup) in an attempt to feed/ drink for themselves. If the PWD has trouble with this activity, the feeding assistant puts his or her hand over the hand of the PWD, in an effort to guide/ support/ assist the PWD with the activity.
~Hand-under-hand feeding technique: Occurs when the feeding assistant holds the object (e.g., fork, spoon, cup) and places the PWD hand over the top of their hand; therefore, the feeding assistants hand is under the hand of the PWD in a more supportive position."
16150101|NCT01780389|Drug|Open-label flexibly dosed milnacipran|
16150102|NCT01780376|Procedure|whole-body vibration (WBV)|whole-body vibration (4 mm amplitude, 25,30,35,40,45,50 Hz)
16150103|NCT01780350|Device|ResQGARD ITD|Patients eligible for the device will receive the ResQGARD attached to a facemask or mouthpiece. The patient will use the device, provided it is tolerated, until their blood pressure is stabilized as determined by EMS personnel.
16150104|NCT01780337|Drug|Oxytocin|Intranasal dose of 20 IU oxytocin
16150105|NCT01780337|Other|Saline|Intranasal dose of saline
16150106|NCT01780324|Drug|Lidocaine|Intervention - intraurethral lidocaine
16150107|NCT01780311|Drug|antiarrhythmic drugs (Flecainide or Propafenone or Sotalol)|
16150108|NCT01780311|Procedure|Catheter Ablation|
16150109|NCT01780285|Device|Nitinol-framed lightweight PTFE mesh for hiatal repair|"The heart-shaped nitinol-framed lightweight PTFE prosthesis Rebound HRD-Hiatus hernia (Minnesota Medical Development, Inc.) of small (4,0 x 4,5 cm) to large size (5,5 х 6,0 cm) is sutured to the crura posteriorly to oesophagus with 3 or 5 interrupted non-absorbable (Ethibond 3-0 by Ethicon, Inc.) sutures, thus performing complete tension-free hiatal repair."
16150110|NCT01780285|Device|Partially absorbable lightweight mesh for hiatal repair|"A fashioned according to the dimensions of hernia defect partially absorbable lightweight mesh Ultrapro (Ethicon, Inc.) will be sutured to both crura posteriorly to oesophagus with 3 to 5 interrupted non-absorbable (Ethibond 3-0 by Ethicon, Inc.) sutures (as tension-free repair). Subsequent 2 to 3 interrupted non-absorbable sutures will approximate crura to completely cover a mesh to preclude its contact with the esophagus (original sandwich sub-lay technique).
~In both arms procedure will be done in a standard fashion: placement of 30 Fr esophageal bougie, reduction of hernia with excision of hernia sac and mobilization of distal esophagus, exposure of borders of hiatal opening, repair of hiatal hernia defect, a short (2,5 - 3,5 cm) 360° fundoplication wrap (floppy-Nissen procedure)."
16150111|NCT01780272|Other|glucose clamp|Each subject will complete one adaptation night visit followed by two experimental night visits, one normoglycaemic and one hypoglycaemic, in randomised order. While subjects are asleep, sleep patterns will be monitored online using polysomnographic recordings during a hypoglycaemic and a normoglycaemic clamp (using constant intravenous (i.v.) infusion of human soluble insulin (Actrapid®)). Plasma glucose will be monitored.
16150112|NCT01780259|Drug|Esketamine|1 spray of 14 percent of esketamine solution (14 mg of esketamine per 100 microlitre) will be administered intranasally by nasal spray pump in each nostril once (Treatment A-total dose: 28 mg), twice with 5 minutes interval (Treatment B-total dose: 56 mg), thrice with 5 minutes interval between each repeated sprays (Treatment C-total dose: 84 mg), thrice with 10 minutes interval between each repeated sprays (Treatment D-total dose: 84 mg) and 4 times with 10 minutes interval between each repeated sprays (Treatment E-total dose: 112 mg). Treatment A, B, C, D will be administered in Cohort 1; Treatment D will be administered in Cohort 2; and Treatment E will be administered in Cohort 3.
16150113|NCT01780259|Drug|Placebo|Single dose of oral placebo will be administered 5 minutes before the first intranasal spray of esketamine solution in the Treatment E of Cohort 3. Placebo solution (solution of water for injection with denatonium benzoate) will be administered intranasally solution by nasal spray pump in the Treatment F of Cohort 3.
16150114|NCT01780259|Drug|Triazolam|Single 0.25-mg oral dose of triazolam will be administered 5 minutes before the first intranasal spray of placebo solution in the Treatment F of Cohort 3.
16150115|NCT01780246|Drug|nusinersen|Administered by intrathecal (IT) injection
16150116|NCT01780233|Drug|Fentanyl 400 µg sublingual spray|
16150117|NCT01780233|Drug|Actiq® 400 µg transmucosally|Actiq® 400 µg is a solid formulation of fentanyl citrate on a plastic stick that dissolves slowly in the mouth for absorption across the buccal mucosa.
16150118|NCT01780233|Drug|Fentanyl citrate injection 100 µg intravenously|
16150119|NCT01780233|Drug|Naltrexone 50 mg|Naltrexone hydrochloride was administered approximately 12 hours and 1 hour prior to and 12 hours after each dose of fentanyl to minimize the occurrence of unacceptable adverse effects (eg, decreased respiration, nausea) often associated with administration of fentanyl.
16150120|NCT01780220|Drug|Abiraterone|Abiraterone acetate 1000mg/day + prednisone alone for one month before initiating the sequence of radiotherapy
16150121|NCT01780207|Device|PFO Closure|
16150122|NCT01780181|Drug|TCM|TCM: In China,TCM herbs are given on the basis of the TCM syndrome differentiation as diagnosed by the TCM herbal specialist. Prescriptions formulated into granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe.The herbal treatment is adapted to the syndromes.
16150123|NCT01780181|Drug|Chemotherapy|treated with single-agent chemotherapy :DOC、NVB、GEM DOC 60mg/m2 d1 Q3W NVB 30mg/m2 d1，d8 Q3W GEM 1200mg/m2 d1，d8 Q3W
16150124|NCT01780129|Drug|Polydatin Injectable|Dilute two 100mg/5mL vials of HW6 into 500mL 0.9% NaCl injection and administer as i.v. infusion over 2 hours. The drug should be given as early as possible right after the IC Form is signed on Day 1, and once every 24 hours for additional 4 doses.
16150125|NCT01780116|Behavioral|Adherence therapy|Systematic and highly structured medication adherence program using the motivational interviewing (MI) technique that focuses on six principles: expressing empathy, developing discrepancy between client's beliefs and evidence, supporting self-efficacy, avoiding argumentation, and rolling with resistance to behavioral change. MI is often able (with in-depth behavioral analysis) to focus on particular consequences of problem behavior, such as medication non-adherence, that have an obvious impact on patients.
16150126|NCT01780090|Other|iPad software|A specialized iPad application, entitled SpeechPrompts, has been developed to treat prosodic difficulties commonly seen in ASDs. SpeechPrompts provides the SLPs that work with students with ASDs an additional tool to treat prosody. The SpeechPrompts software offers visual support and biofeedback to change prosody. These two tools are not typically available for school-based SLPs.
16150127|NCT01780077|Drug|RXI-109|Multiple intradermal injections of RXI-109 at incision sites
16150128|NCT01780077|Drug|Placebo|Multiple intradermal injections of placebo at incision sites
16150129|NCT01780064|Behavioral|interviews with a psychologist|interviews with a psychologist
16150130|NCT01780064|Behavioral|Questionnaires|Questionnaires
16150131|NCT01780051|Drug|Repaglinide/Metformin combination, Repaglinide, Metformin|"Co-administration of Repaglinide 2mg and Metformin HCl 500mg at once in period 1.
~Administration of the Combination tablet of Repaglinide 2mg/Metformin HCl 500mg) in period 2."
16150132|NCT01780051|Drug|Repaglinide/Metformin combination, Repaglinide, Metformin|"Administration of the Combination tablet of Repaglinide 2mg/Metformin HCl 500mg) in period 1.
~Co-administration of Repaglinide 2mg and Metformin HCl 500mg at once in period 2."
16150133|NCT01780038|Behavioral|Receipt of Genetic Results|Participants will receive the results of genotyping for RS1051730
16150134|NCT01780038|Behavioral|No results given|Participants will not be offered to receive the results of genotyping for RS1051730 until all data collection has been completed.
16150135|NCT01780025|Behavioral|Auditory evoked potentials and audiometry|
16150136|NCT01780025|Behavioral|Auditory evoked potentials|Different protocols for audiometry and auditory evoked potentials
16150137|NCT01780012|Behavioral|Osteoporosis prevention program|Women will receive an oral information and advices on osteoporosis, a written leaflet on osteoporosis (risk factors, diagnosis, prevention and treatments), a letter and a leaflet on osteoporosis management to give to their family physician and phone call reminders (D15, D30, D45) to advise them to consult their family physician and, if they have a BMD prescription, to perform their BMD
16150138|NCT01779999|Other|PICC-carrying patients|Echographic monitoring of patients carrying a peripherally inserted central catheter
16150139|NCT01779973|Behavioral|Remote Observed Dosing|
16150140|NCT01779960|Other|Londrina|Two groups of patients, one group in Londrina and another group in Leuven, will be simultaneously and objectively evaluated concerning their physical activity in daily life during one week in two different moments: in January 2013 (winter in Leuven and summer in Londrina), and then the same two groups of patients will be once again simultaneously re-evaluated during another week in July 2013 (summer in Leuven and winter in Londrina).
16150141|NCT01779960|Other|Leuven|Two groups of patients, one group in Londrina and another group in Leuven, will be simultaneously and objectively evaluated concerning their physical activity in daily life during one week in two different moments: in January 2013 (winter in Leuven and summer in Londrina), and then the same two groups of patients will be once again simultaneously re-evaluated during another week in July 2013 (summer in Leuven and winter in Londrina).
16150142|NCT01779947|Drug|Estradiol Vaginal Tablets 10 mcg|
16150143|NCT01779947|Drug|placebo|
16150144|NCT01779921|Drug|activated recombinant human factor VII|Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
16150145|NCT01779921|Drug|Fresh frozen plasma (Source unspecified)|Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
16150146|NCT01779921|Drug|Plasma-derived FVII (LFB)|Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
16150147|NCT01779921|Drug|Prothrombin Complex conc. (PCC)|Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
16150148|NCT01779921|Drug|Plasma-derived FVII conc. (pdFVII Baxter)|Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
16150149|NCT01779921|Drug|Plasma-derived FVII conc. (pdFVII PFL)|Treatment of bleeding episodes and treatment during surgery and prophylaxis as per discretion of the investigator.
16150150|NCT01779908|Dietary Supplement|Vitamin D|
16150151|NCT01779908|Other|Placebo|
16150152|NCT01779895|Dietary Supplement|Lactobacillus paracasei probiotic strain|
16150153|NCT01779895|Dietary Supplement|Placebo|maltodextrin
16150154|NCT01779882|Drug|Busulfan-Cyclophosphamide as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell Transplantation|Test the hypothesis, that the order of application of Busulfan (BU) and Cyclophosphamide (CY) has an impact on toxicity after allogeneic Hematopoietic stem cell transplantation (HSCT) and that CY-BU reduces liver toxicity compared to BU-CY.
16150155|NCT01779882|Drug|Cyclophosphamide-Busulfan as Conditioning Regimen before Allogeneic Hematopoietic Stem Cell Transplantation|Test the hypothesis, that the order of application of Busulfan (BU) and Cyclophosphamide (CY) has an impact on toxicity after allogeneic Hematopoietic stem cell transplantation (HSCT) and that CY-BU reduces liver toxicity compared to BU-CY.
16150156|NCT01779869|Drug|Regadenoson|Regadenoson 400 micrograms will be administered in a single IV bolus (<10 seconds) via an antecubital cannula and followed by 5 mL of saline flush. 10-20 seconds after the regadenoson is administered, 10 mCi of 13N-ammonia as a bolus, and 0.075 mmol/Kg of gadobenate dimeglumine MR contrast agent at a rate of 5 mL/sec followed by a 15 mL normal saline flush will be administered simultaneous, each into an antecubital vein, and a 15 min list-mode PET acquisition will be acquired simultaneously with the MR perfusion imaging.
16150157|NCT01779856|Device|REVEAL Insertable Cardiac Monitor (ICM)|
16150158|NCT01779843|Drug|Cytarabine|
16150159|NCT01779843|Drug|Idarubicin|
16150160|NCT01779843|Drug|Alisertib|
16150161|NCT01779830|Drug|LY2624803 - Capsules|Administered orally as capsules.
16150162|NCT01779830|Drug|Zolpidem - Tablets|Administered orally as tablets.
16150163|NCT01779830|Drug|Placebo - Capsules|Administered orally as capsules.
16150164|NCT01779830|Drug|Placebo - Tablets|Administered orally as tablets.
16150165|NCT01779817|Behavioral|Assessment of intellectual development, capacities of attention, learning process and degree of hyperactivity of the children between 6 and 9 years.|
16150166|NCT01779804|Procedure|OFAR|OFAR
16150167|NCT01779791|Drug|PCI-32765 (Ibrutinib)|560 mg capsules administered orally once daily, continuously on a 21-day cycle until progressive disease.
16150168|NCT01779765|Dietary Supplement|PHGG|
16150169|NCT01779765|Dietary Supplement|Maltodextrin|
16150170|NCT01779739|Procedure|Perineorrhaphy|Procedure to build up the vaginal opening
16150171|NCT01779726|Radiation|CT scan before chest physician|Patients referred to department of lung medicine are randomised according to the month of birth. Patients born in even months are CT scan before a consultation with a chest physician
16150172|NCT01779726|Radiation|Usual diagnostic workup|Patients born in odd months seen in the department of lung medicine by a chest physician and maybe then CT scanned (usual workup practice according to the fast track evaluation)
16150173|NCT01779713|Genetic|Case-control transcriptomic study|No intervention
16150174|NCT01779700|Drug|Fingolimod|0.5mg each day of 8 week cycle
16150175|NCT01779700|Drug|placebo|1 tablet each day of 8 week cycle
16150176|NCT01779687|Drug|raltegravir|Raltegravir 400 mg BID for 7 days
16150177|NCT01779687|Drug|Atorvastatin|Atorvastatin 20 mg QD for 7 days
16150178|NCT01779661|Other|Infant Aquatics|Infant Aquatics in this study is composed of a set of pre-structured movements and techniques of relaxation, through harmonic integration of various approaches, each having a role in a specific time-window or in the infant's developmental sequence along study interventional timeline
16150179|NCT01779661|Other|Infant Massage|Infant Massage
16150180|NCT01779648|Device|DVT-3000|
16150181|NCT01779648|Device|SCD Express|
16150182|NCT01779635|Device|oXiris as first filter|2 arms - each start off CRRT with either oXiris or M150 as first hemofilter, and then do cross-over to either hemofilters in a sequential manner when the former clots
16150183|NCT01779635|Device|M150 as first filter|start off with M150 as first hemofilter, then cross-over to oXiris when former clots, and then to M150, and then lastly to oXiris
16150184|NCT01779622|Other|Mixed meal|Ingestion of mixed meal
16150185|NCT01779609|Drug|Bosentan|
16150186|NCT01779609|Drug|Placebo|
16150187|NCT01779609|Behavioral|Exercise|Supervised exercise training program of 8 weeks, for 3x/week
16150188|NCT01779596|Drug|Bosentan|
16150189|NCT01779596|Drug|Placebo|
16150190|NCT01779570|Drug|Macrolide treatment|
16150191|NCT01779557|Drug|Huaren Peritoneal Dialysate|Huaren Peritoneal dialysate CAPD 3-5 times/d
16150192|NCT01779557|Drug|Baxter Peritoneal Dialysate|Baxter Peritoneal dialysate CAPD 3-5 times/d
16150193|NCT01779544|Other|Brief intervention, an educational model|The goal of the the brief intervention is to provide the patient knowledge to reduce uncertainty so that he or she can understand what is important after lumbar disc surgery so that belief in self-efficacy increases.
16150194|NCT01779544|Other|Exercise therapy|Patients are instructed to do prescribed exercises the first 3 months after surgery, and to log when they do these
16150195|NCT01779518|Drug|Sofosbuvir|
16150196|NCT01779518|Drug|Ribavirin|
16150197|NCT01779518|Drug|Pegylated Interferon|
16150198|NCT01779505|Biological|GS-4774|GS-4774 is a recombinant yeast-based biological product engineered to express HBV antigens. The product is a heat-killed yeast (S. cerevisiae) containing a chimera of HBV X, Score, and Core antigens.
16150199|NCT01779492|Drug|GL2907|once a day
16150200|NCT01779492|Drug|Oxycontine CR 10mg|twice a day
16150201|NCT01779479|Drug|Cabacitaxel|Cabazitaxel 25 mg/m² i.v. (Day 1) every 3 weeks (cycle) as 1-hour i.v infusion for a total of up to 4 cycles over a maximum total treatment period of 15 weeks before surgery
16150202|NCT01779479|Drug|Paclitaxel|Paclitaxel 80 mg/m² as 1-hour i.v infusion. Patients will receive weekly (Days 1, 8, 15) paclitaxel administrations for a maximum of 12 infusions for a maximum of 4 cycles over a maximum total treatment period of 15 weeks before surgery (1 cycle = 3 weeks).
16150203|NCT01779466|Drug|Desmopressin|
16150204|NCT01779466|Drug|Placebo (not active)|
16150205|NCT01779453|Drug|ETC-1002|Week 1-2, 60 mg/day; Week 3-4, 120 mg/day; Week 5-6, 180 mg/day; Week 7-8, 240 mg/day
16150206|NCT01779453|Drug|Placebo|Placebo once daily for 8 weeks
16150207|NCT01779453|Drug|Atorvastatin|Atorvastatin 10mg once daily for 8 weeks
16150208|NCT01779440|Behavioral|Electronic Decision Support System|
16150273|NCT01778998|Procedure|SICS-group|small incision cataract surgery is done
16150321|NCT01778530|Drug|TRC105|Intravenous infusion.
16150209|NCT01779427|Behavioral|AIM|An online, 12 week research study to learn if a computer-based intervention that provides direct attention and metacognitive strategy development can improve attention, memory, and executive control in adolescents with moderate-to-severe TBI who are experiencing attention difficulties post injury.
16150210|NCT01779414|Other|STAT-ED Intervention|Participants in this group will receive a motivational interview conducted by a study trained social worker, where the social worker and the family will discuss the participants issues, thoughts and feelings about receiving treatment, barriers to treatment and methods of overcoming those barriers. The study trained social worker will also make a referral for a mental health follow-up for the patient.
16150211|NCT01779401|Drug|Clopidogrel 75mg|
16150212|NCT01779401|Drug|Clopidogrel 150mg|
16150213|NCT01779401|Drug|Aspirin 100mg|
16150214|NCT01779401|Drug|Cilostazol 100mg|
16150215|NCT01779388|Procedure|Bronchoscopy|During a general anaesthesia, an evaluation will be done by conventional bronchoscopy guided by fluoroscopy and by bronchial endoscopy guided by electromagnetic navigation, the selection of order in techniques being randomly assigned.
16150216|NCT01779375|Drug|Metformin|
16150217|NCT01779375|Drug|Glargine|
16150218|NCT01779362|Drug|Metformin|Titrated to 1000 mg BID
16150219|NCT01779362|Drug|Liraglutide|Titrated to 1.8 mg/day
16150220|NCT01779362|Drug|Glargine|Titrated to target fasting glucose <90 mg/dl
16150221|NCT01779362|Drug|Placebo|Matching to metformin 1000 mg BI
16150222|NCT01779349|Device|"Dynamic Urine Vibration Holter"|"each subject will undergo intervention for the diagnosis of bladder outlet obstruction first using the Dynamic Urine Vibration Holter and then urodynamically by pressure flow study"
16150223|NCT01779336|Drug|PL225B|"Patients will receive study drug on a daily basis for twenty-one (21) days according to the dose and schedule specified for a particular cohort of therapy.
~This 21 day administration will define a treatment cycle.
~Patients may receive consecutive treatment cycles until evidence of disease progression, intolerance of therapy, or withdrawal from the protocol as specified."
16150224|NCT01779323|Other|Pre and Post Sling Pelvic MRI|Pre and Post Sling Pelvic MRI
16150225|NCT01779284|Drug|Travoprost/timolol therapy|Evaluation of 24-hour pressure efficacy with travoprost/timolol therapy after 3 months of chronic dosing
16150226|NCT01779284|Drug|Latanoprost/Timolol therapy|Evaluation of 24-hour pressure efficacy for this drug after 3 months of chronic therapy
16150227|NCT01779271|Drug|Pelubiprofen|
16150228|NCT01779271|Drug|Loxoprofen|
16150229|NCT01779258|Drug|glycerol, paraffin (liquid and white soft)|1 application in the morning and in the evening
16150230|NCT01779258|Device|Atopiclair®|1 application in the morning, in the afternoon and in the evening
16150231|NCT01779258|Drug|Locatop@|"During the Run-In period:
~1 application in the morning and in the evening during a maximum of 21 days"
16150232|NCT01779258|Drug|Locapred@|"During the 3 months study treatment:
~1 application in the evening in case of flare "
16150233|NCT01779245|Dietary Supplement|Calcium|Milk-extracted calcium supplement will be used to modulate the calcium content of the milkshakes used.
16150234|NCT01779245|Dietary Supplement|Placebo|
16150235|NCT01779232|Drug|Danazol|100 mg day for 4 monthh in women with diagnosed endometriosis before IVF
16150236|NCT01779232|Drug|placebo|administered daily like the active comparator
16150237|NCT01779219|Device|iMRI-guided brain tumour biopsy|The PoleStar N20 iMRI system (Medtronic Navigation, Louisville, CO, USA) with a 0.15-T constant magnet was used in all procedures.
16150238|NCT01779219|Device|Stereotactic frameless brain tumour biopsy|The entry point, target and optimal biopsy trajectory were defined by the operator before the operation on the basis of the preoperatively obtained high-field MR images with the use of a neuronavigation workstation (Cranial 5, StealthStation Application Software, Medtronic Navigation, Louisville, CO, USA).
16150239|NCT01779206|Drug|Epirubicin|
16150240|NCT01779206|Drug|Cyclophosphamide|
16150241|NCT01779206|Drug|Docetaxel|
16150242|NCT01779206|Drug|Paclitaxel|
16150243|NCT01779193|Dietary Supplement|lactic acid bacteria|oral lactobacillus capsule (dose of 2 * 10^9 cfu per capsule), one pill daily
16150244|NCT01779193|Dietary Supplement|cranberry|oral cranberry capsule, one pill daily
16150245|NCT01779193|Dietary Supplement|placebo|placebo capsule without lactic acid bacteria and cranberry, one pill daily
16150246|NCT01779167|Drug|Thalidomide|Thalidomide 50 mg (every ODD day of a 28 day cycle: Days 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 & 27)
16150247|NCT01779167|Drug|Lenalidomide|Lenalidomide (every EVEN day of a 28 day cycle: Days 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26 & 28). Lenalidomide will be initiated at a starting dose of 5 mg.
16150248|NCT01779167|Drug|Rituximab|Rituximab 375 mg/m2 IV on Days 1, 8, 15 and 22 (+/- 2 days) and then again on the same weekly x 4 schedule every 6th cycle thereafter (Cycle 7, 13, 19, etc).
16150249|NCT01779128|Procedure|PET-CT|
16150250|NCT01779128|Procedure|MR-PET|
16150251|NCT01779102|Biological|C-Tb|C-Tb is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme
16150252|NCT01779102|Biological|Tuberculin PPD RT 23 SSI|Tuberculin is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme
16150253|NCT01779102|Biological|C-Tb / Tuberculin PPD RT 23 SSI|The C-Tb and Tuberculin agents are administered by the Mantoux injection technique to each volunteer in the RIGHT and LEFT forearm according to a double blind randomisation scheme
16150254|NCT01779089|Drug|Minocycline 100 mg po bid for 6 months|Minocycline 100 mg po bid or placebo for 6 months
16150255|NCT01779089|Drug|placebo|
16150256|NCT01779076|Procedure|30% oxygen|
16150257|NCT01779076|Procedure|100% oxygen|
16150258|NCT01779063|Behavioral|web based multimedia intervention|cognitive therapy based web intervention
16150259|NCT01779063|Other|educational booklet|patient education booklet
16150260|NCT01779050|Drug|Doxorubicin|
16150261|NCT01779050|Biological|Trastuzumab|
16150262|NCT01779050|Drug|Cyclophosphamide|
16150263|NCT01779050|Drug|Paclitaxel|
16150264|NCT01779050|Drug|Epirubicin|
16150265|NCT01779050|Drug|Docetaxel|
16150266|NCT01779050|Drug|Carboplatin|
16150275|NCT01778998|Procedure|SICS stab-incision|Small incision cataract surgery with stab-incision is done
16150276|NCT01778985|Drug|Premarin|
16150277|NCT01778985|Other|Placebo|
16150278|NCT01778972|Other|Otago home exercise programme|"Otago home exercise program was designed specifically to prevent falls. It consists of a set of leg muscle strengthening and balance retraining exercises progressing in difficulty, and a walking plan.
~The exercise are individually prescribed and increase in difficulty during a series of five home visits by a physiotherapist."
16150279|NCT01778972|Other|Motivational interviewing plus Otago|This group is not only exercising at home but also getting motivational interviewing from the physiotherapist at he five home visits. The physiotherapists doing motivational interviewing are specially trained in motivational interviewing.
16150280|NCT01778959|Device|Malyugin Ring|insertion of a Malyugin Ring to stabilite the pupil during cataract surgery
16150281|NCT01778959|Device|Iris hooks|insertion of iris retractors to stabilize the pupil during cataract surgery
16150282|NCT01778959|Device|standard OVD|use of a standard cohesive OVD during cataract surgery
16150283|NCT01778959|Device|OVD|use of a highly cohesive OVD during cataract surgery
16150284|NCT01778946|Drug|Low Dose Nicotine (7mg)|
16150285|NCT01778946|Drug|Moderate Dose Nicotine (14mg)|
16150286|NCT01778933|Drug|EC17|
16150287|NCT01778920|Drug|EC17 imaging contrast agent|This is an imaging agent to locate lung adenocarcinoma cancer cells during surgery
16150288|NCT01778907|Other|Genotype information accompanied by a drug dosing advice|Dosing advices for deviating genotypes (Poor Metabolizer, Intermediate Metabolizer, Ultrarapid Metabolizer)based on the guidelines of the Royal Dutch Pharmacists Association (KNMP).
16150289|NCT01778881|Other|Massage and stretching exercises|The routine to be used in this group (stretching, massage, and diaphragmatic breathing).
16150290|NCT01778881|Other|Relaxation and imagination therapies|The routines to be adopted will focus on progressive muscle relaxation associated to imagination and diaphragmatic breathing.
16150291|NCT01778881|Other|Dental treatment|Restoring treatment will involve direct reconstruction of the anterior guides (incisive faces of the incisive and canine teeth) with resin.
16150292|NCT01778881|Other|Massage, exercises, relaxation and imagination therapies|The routine to be used in this group (stretching, massage, diaphragmatic breathing, progressive muscle relaxation and imagination therapies).
16150293|NCT01778855|Other|IV t-PA and normothermia|
16150294|NCT01778855|Device|IV-tPA and hypothermia|
16150295|NCT01778842|Drug|Clopidogrel|Patient will be randomized to this intervention will receive the standard dose of clopidogrel and after 15 days and 30 days we will control the responsivness of the study drug.
16150296|NCT01778842|Drug|Prasugrel|Patient will be randomized to this intervention will receive the low dose of prasugrel and after 15 days and 30 days we will control the responsivness of the study drug.
16150297|NCT01778829|Procedure|CPAP ventilation mode|Patients are ventilated through a nasal prong coneected to a ventilator that provides a continuous positive airway pressure
16150298|NCT01778829|Procedure|NIPPV ventilation mode|Patients are ventilated through a nasal prong connected to a ventilator that provides a non synchronized intermittent positive pressure ventilation
16150299|NCT01778803|Drug|defactinib|
16150300|NCT01778803|Drug|Paclitaxel|
16150301|NCT01778790|Device|Deep Brain Stimulation with Activa PC Multi-program Neurostimulator|"Device: DBS 130 Hertz (Hz) frequency, 90us pulsewidth, 4 Volt (V) currency Amplitude
~Device: DBS - No Stimulation (Sham) 130 Hertz (Hz)frequency, 90us pulsewidth, 0 Volt (V) currency Amplitude"
16150302|NCT01778777|Device|Universe Reverse Prosthesis|Implantation of an universe reverse prosthesis
16150303|NCT01778751|Behavioral|Home Telehealth with Behavioral Education Component|The primary effectiveness outcome for this study will be hemoglobin A1c. Secondary effectiveness outcomes will include measures of diabetes self-care, self-reported medication adherence, and depressive symptoms.
16150304|NCT01778738|Procedure|Bariatric surgery, either gastric bypass surgery or sleeve gastrectomy|Vertical sleeve gastrectomy or a gastric bypass surgery in morbidly obese individuals with type 2 diabetes. Random allocation to surgical intervention
16150305|NCT01778738|Procedure|Sleeve gastrecomy|Vertical sleeve gastrectomy
16150306|NCT01778738|Procedure|Bastric bypass|Gastric bypass surgery
16150307|NCT01778712|Behavioral|Multi-level intervention|The development of a lifestyle program intended to intervene on the individual, social network and community over two years
16150308|NCT01778699|Dietary Supplement|lozenges|"The test products for the study is manufactured and provided by CD Investments srl, Italy. The placebo lozenges will look like the active lozenges with the same taste and weight of 1 gram containing only the ingredients listed above in the same proportion as the active but with no L. brevis CD2. It will not be possible to differentiate the two products.
~The study center and the monitor must be informed of any deficiency in the study products (products will be kept at 4° degrees during the study)."
16150309|NCT01778686|Drug|Citalopram and Pindolol|"Citalopram: selective serotonin reuptake inhibitor
~Pindolol: non-selective beta blocker and 5-HT1A receptor antagonist"
16150310|NCT01778686|Other|Placebo|On the second PET scanning day, subjects received a protein drink as well as a 50 ml saline infusion over 1 hour starting 30 min before PET scanning.
16150311|NCT01778686|Dietary Supplement|Acute tryptophan depletion|
16150312|NCT01778673|Procedure|Cast immobilization|
16150313|NCT01778660|Other|Type of Counselling (Mnemonic)|
16150314|NCT01778660|Other|Standard|
16150315|NCT01778647|Dietary Supplement|Stimulants plus Lovaza|Patients randomized to stimulants plus Lovaza (Omega-3 fatty acids). Treated and evaluated for up to 16 weeks. Conners and CGI scales filled out by parents, teachers and evaluators on each visit
16150316|NCT01778647|Drug|Stimulants plus placebo|Patients randomized to usual dose of stimulants plus placebo. Patients evaluated for up to 16 weeks. Conners rating scales and CGI filled out by evaluators, parents and teachers.
16150317|NCT01778634|Drug|Azithromycin|Azithromycin intravenous 20 mg/kg every 24 h x 3 days
16150318|NCT01778634|Drug|Placebo|D5W
16150319|NCT01778621|Device|Acupuncture(Hwato®)|acupuncture using 4cm long disposable stainless steel hair-thin needles manufactured by Suzhou medical appliance factory (China).
16150320|NCT01778556|Biological|Metreleptin|Recombinant analog of the human hormone, leptin
16150322|NCT01778517|Other|Group Psychotherapy|
16150323|NCT01778517|Other|Cognitive behavior therapy based on self help|
16150324|NCT01778465|Behavioral|Low salicylate diet|Participants followed a 7 days period under a Low salicylate diet
16150325|NCT01778465|Behavioral|Normal Diet|Participants followed a 7 days period under a Normal Diet
16150326|NCT01778452|Procedure|endometrial biopsy|endometrial biopsy
16150327|NCT01778439|Drug|OMP-52M51|
16150328|NCT01778413|Drug|ATRIPLA|
16150329|NCT01778400|Procedure|radiofrequency ablation|radiofrequency ablation for the treatment as a new therapy as compared with ethanol ablation as a conventional therapy
16150330|NCT01778400|Procedure|Ethanol ablation|ethanol ablation as a conventional/control therapy to be compared with a new experimental therapy--radiofrequency ablation
16150331|NCT01778387|Procedure|Laparoscopic ventral hernia repair|Intraperitoneal ventral hernia repair with the use of Gore-tex Patch
16150332|NCT01778374|Other|No participant choice of counselor|Participants in this arm of the study are randomized to an interactive video counselor with no choice of counselor. This is delivered via a touchscreen tablet device.
16150333|NCT01778374|Other|Participant choice of counselor|Participants in this arm of the study are randomized to an interactive video counselor with a choice of four different counselors. These gender and ethnically diverse counselors are delivered via a touchscreen tablet device.
16150334|NCT01778348|Device|Overnight closed-loop|The closed-loop system is purpose-built and comprises a hand-held computer containing a model predictive control (MPC) based glucose control algorithm and communicating with the CGM device and the insulin pump.
16150335|NCT01778348|Device|Real-time CGM alone|Subject glucose level controlled by usual insulin pump therapy in conjunction with real time continuous glucose monitoring (CGM)
16150336|NCT01778335|Procedure|Endovascular thrombectomy/thrombolysis|Endovascular mechanical thrombectomy or thrombolysis
16150337|NCT01778322|Procedure|Intracranial aneurysm embolization|Treatment of intracranial aneurysms
16150338|NCT01778309|Dietary Supplement|n-acetylcysteine supplementation|"n-acetylcysteine administration: 20 mg//kg/day, orally, daily for eight days following exercise
~placebo administration: 500 mL orally, daily for eight days following exercise"
16150339|NCT01778296|Device|the neurocutaneous island flap|The neurocutaneous island flap of the dorsal branch of the digital nerve can be used for repair the defects of the proximal and middle phalanxes of adjacent fingers.
16150340|NCT01778283|Biological|Acetate-free dialysis solution|the hemodialysis solution that does not contain acetate as buffer
16150341|NCT01778270|Device|Body Bioimpedance Sensor|
16150342|NCT01778257|Dietary Supplement|Mate extract|Mate is a South American herb that is traditionally prepared as a tea and used, among others, for weight reduction.
16150343|NCT01778257|Dietary Supplement|Placebo|Amount and calorie of placebo are same with Mate extracts.
16150344|NCT01778244|Drug|metformin|1000mg/day for 24 weeks
16150345|NCT01778231|Dietary Supplement|Nutrof Total|Antioxidant and trace element supplement
16150346|NCT01778231|Dietary Supplement|Placebo|
16150347|NCT01778218|Radiation|Radiolabeled (99Tc) EC-DG (ethylenedicysteine-deoxyglucose|An injection of Technetium ethylenedicysteine-deoxyglucose (99mTc-EC-DG) to yield a target activity of 25 mCi (range of 10-25 mCi) with no more than 250 micrograms of EC-DG to be administered (there must be a minimum of 24 hours between Visit 1 and 2 administrations). Investigational Product to be given by IV push.
16150348|NCT01778205|Other|Observational|
16150349|NCT01778192|Drug|Polyethylene glycol|-group 1 (same day PEG) received 4 L of PEG at 6 hours before procedure on the day of the colonoscopy
16150350|NCT01778192|Drug|Polyethylene glycol|-group 2 (split PEG, N=50) received 2 L of PEG at 6:00 p.m the evening before colonoscopy and 2 L of PEG at 4-6 hours before procedure
16150351|NCT01778192|Drug|Sodium picosulphate with magnesium citrate|-group 3 (SPMC 2) received one sachet of SPMC at 6 p.m the evening before colonoscopy and another sachet of SPMC at 4-6 hours before procedure
16150352|NCT01778192|Drug|Sodium picosulphate with magnesium citrate|-group 4 (SPMC 3) received one sachet of SPMC at 6 p.m and the other sachet at 9 p.m the evening before colonoscopy and another sachet at 4-6 hours before procedure.
16150353|NCT01778179|Drug|Tri-luma|"Pre-procedure phase (From Baseline up to Week 2) treated daily for their solar lentigines with the investigational drug (Tri-Luma® cream) for 2 weeks.
~Post-procedure phase (From week 2 up to Week 13 - Visit )
~- Tri-Luma® cream treatment phase (from week 5 up to week 13 - visit 3 up to visit 5):The investigational drug (Tri-Luma® cream) will be applied again (group 1) for a minimum of 4 weeks and up to 8 weeks, according to the Global Improvement of solar lentigines and absence of PIH."
16150354|NCT01778179|Procedure|Cryotherapy (CRY-AC3® device)|Procedure performed at week 2.
16150355|NCT01778166|Drug|Immuno-enhanced|Immediately drip 37°C saline 20 ml/h and exchange to drip 37°C enteral nutrition fluid concerning omega-3-unsaturated fatty acids 20 ml/h at postoperative 6 h via jejunostomy tube or nasogastric tube
16150356|NCT01778166|Drug|Standard early enteral nutrition|Immediately drip 37°C saline 20 ml/h and exchange to drip 37°C standard enteral nutrition fluid 20 ml/h at postoperative 6 h via jejunostomy tube or nasogastric tube
16150357|NCT01778153|Behavioral|Equinox Personal Coaching|Specially designed strength and aerobic exercise training program that consists of 36 sessions over 12 weeks.
16150358|NCT01778140|Other|Patient-specific computerized reminder|The intervention targets are physicians,not patients. This CDSS alerts physicians only when the patient with high risk of contrast-induced-nephropathy(CIN) is encountered. On the contrast, the CDSS will not alert when the patient without CIN risk is encountered.
16150359|NCT01778140|Other|Non-patient-specific computerized reminder|The non-patient-specific computerized reminder always pops up to remind physicians to check their patient's CIN risk no matter what CIN risk is.
16150360|NCT01778127|Behavioral|Activity Monitor|Measurement of physical activity.
16150361|NCT01778127|Behavioral|Interactive Website|Zamzee is a meter that measures activity and a website that makes moving fun. Parents of participants can set activity goals. Activity is uploaded to the website where participants track progress and earn rewards by increasing their level of activity. Participants can view leaderboards and check how other participants are doing.
16150415|NCT01777776|Drug|LEE011|LEE011 will be administered orally, once daily for 21 consecutive days followed by a 7-day planned break (28-day cycle).
16150362|NCT01778127|Behavioral|Educational Materials|All participants will receive educational handouts about physical activity. Participants will receive the educational handouts again via mail three and five months into the study to reinforce the importance of physical activity and maintain compliance.
16150363|NCT01778114|Dietary Supplement|Vitamin D2 in orange juice|1000 IU dose
16150364|NCT01778114|Dietary Supplement|Vitamin D3 in orange juice|1000 IU
16150365|NCT01778114|Dietary Supplement|Vitamin D2|capsule, 1000 IU
16150366|NCT01778114|Dietary Supplement|Vitamin D3|capsule, 1000 IU
16150367|NCT01778114|Other|Placebo|Placebo
16150368|NCT01778101|Drug|Lansoprazole|lansoprazole 1mg/kg twice a day for 14days
16150369|NCT01778088|Drug|I-131-CLR1404 Injection|
16150370|NCT01778075|Drug|Tramadol HCl 75 mg/Acetaminophen 650 mg (Newly developed ULTRACET ER)|Single oral dose of newly developed ULTRACET ER, (Tramadol HCl/Acetaminophen 75/650 mg), administered under fasted condition.
16150371|NCT01778075|Drug|Tramadol HCl 75 mg/Acetaminophen 650 mg (Marketed ULTRACET ER)|Single oral dose of marketed ULTRACET ER, (Tramadol HCl/Acetaminophen 75/650 mg), administered under fasted condition.
16150372|NCT01778062|Drug|Indacaterol|Indacaterol 150µg once daily oral inhalation
16150373|NCT01778062|Drug|Control|Placebo once daily oral inhalation
16150374|NCT01778049|Drug|BI 10773|Empagliflozin active
16150375|NCT01778049|Drug|BI 10773 Placebo|Empagliflozin placebo
16150376|NCT01778049|Drug|BI 10773 / BI 1356|Empagliflozin / Linagliptin 25/5 mg Dose FDC active
16150377|NCT01778049|Drug|BI 10773|Empagliflozin active
16150378|NCT01778049|Drug|BI 10773 / BI 1356|Empagliflozin / Linagliptin 10/5 mg Dose FDC active
16150379|NCT01778049|Drug|BI 10773 / BI 1356 Placebo|Empagliflozin / Linagliptin 10/5 mg Dose placebo FDC
16150380|NCT01778049|Drug|BI 10773|Empagliflozin active
16150381|NCT01778049|Drug|BI 10773|Empagliflozin active
16150382|NCT01778049|Drug|BI 10773|Empagliflozin active
16150383|NCT01778049|Drug|BI 10773 / BI 1356 Placebo|Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo
16150384|NCT01778049|Drug|BI 10773 Placebo|Empagliflozin placebo
16150385|NCT01778049|Drug|BI 10773 / BI 1356 Placebo|Empagliflozin / Linagliptin 10/5 mg Dose FDC placebo
16150386|NCT01778049|Drug|BI 10773|Empagliflozin active
16150387|NCT01778049|Drug|BI 10773 / BI 1356 Placebo|Empagliflozin / Linagliptin 25/5 mg Dose FDC placebo
16150388|NCT01778023|Drug|somatropin|A weekly dosage of 0.469 mg of somatropin per kg of body weight per week will be injected subcutaneously (under the skin) in the evening in 7 days per week.
16150389|NCT01778010|Drug|Modafinil 0 mg|Modafinil (0 mg/day)
16150390|NCT01778010|Drug|Modafinil 200 mg|Modafinil (200 mg/day)
16150391|NCT01778010|Drug|Modafinil 400 mg|Modafinil (400 mg/day)
16150392|NCT01778010|Drug|Cocaine 0 mg|Cocaine (0 mg/day)
16150393|NCT01778010|Drug|Cocaine 12 mg|Cocaine (12 mg/day)
16150394|NCT01778010|Drug|Cocaine 25 mg|Cocaine (25 mg/day)
16150395|NCT01778010|Drug|Cocaine 50 mg|Cocaine (50 mg/day)
16150396|NCT01777997|Drug|Emtricitabine/rilpivirine/tenofovir disoproxil fumarate|"Step 1: From entry through week 12, the participants received no study treatment. From week 12 through week 60, the participants received one fixed dose combination emtricitabine/rilpivirine/tenofovir disoproxil fumarate (FTC/RPV/TDF) tablet daily.
~Step 2 (Optional): From week 60 through week 108, the participants either received one FTC/RPV/TDF tablet daily or no study treatment."
16150397|NCT01777945|Drug|capecitabine|Participants received capecitabine according to individualized physician-prescribed regimen.
16150398|NCT01777945|Drug|docetaxel|Participants received docetaxel according to individualized physician-prescribed regimens.
16150399|NCT01777919|Drug|Temozolomide|
16150400|NCT01777919|Drug|Disulfiram|
16150401|NCT01777919|Drug|Copper|
16150402|NCT01777893|Behavioral|High protein/ high intensity physical activity (HP-HI)|Participants follow a high protein diet and a high intensity physical activity intervention
16150403|NCT01777893|Behavioral|High protein / moderate intensity physical activity (HP-MI)|Participants follow a high protein diet and moderate intensity physical activity intervention
16150404|NCT01777893|Behavioral|Moderate protein/ high intensity physical activity (MP-HI)|Participants follow a moderate protein diet and a high intensity physical activity intervention
16150405|NCT01777893|Behavioral|Moderate protein/ moderate intensity physical activity (MP-MI)|Participants follow a moderate protein diet and moderate intensity physical activity intervention
16150406|NCT01777867|Procedure|Cough Reflex Sensitivity|Subjects inhaled increasing concentrations of citric acid, which induces coughing in a dose-dependent, reproducible matter. Following each inhalation, the number of coughs in the subsequent 15 seconds was counted and recorded. The challenge was terminated once the citric acid induced 5 or more coughs and the logarithmic (base 10) concentration provoking 5 coughs was recorded.
16150407|NCT01777867|Procedure|Methacholine Challenge|A baseline spirometry was used to assess how well the participant's lungs work by measuring how much air was inhale, how much was exhale and how quickly the participant exhaled. If this was normal, the subject inhaled slowly and deeply the methacholine test solution from a nebulizer and was told to hold their breath for 5 seconds. This was repeated until 5 inhalations were performed in no more than two minutes.
16150408|NCT01777854|Drug|Omeprazole|The principal investigator will be contacted and will work with the research pharmacist to obtain the omeprazole (20 mg PO daily for patients >20kg) and placebo. The placebo does not look like the omeprazole, however this will not be an issue because none of the subjects will have knowledge of how the medications look. The medication will be locked in the designated medication cabinet at each office. It will be prepackaged for a 28 day course. The patient will start the treatment 4 weeks prior to tonsillectomy and stop the day before surgery. The medication will be given to the patient once the consent and assent are signed. This will avoid an unnecessary office visit to improve patient compliance.
16150409|NCT01777841|Other|Electronic Care plan delivery|
16150410|NCT01777841|Other|Standard care|
16150411|NCT01777815|Device|NeoChord DS1000 Artificial Chordae Delivery System|
16150412|NCT01777802|Radiation|SBRT|
16150413|NCT01777802|Radiation|IMRT|
16150414|NCT01777802|Radiation|Brachytherapy|
16150416|NCT01777776|Drug|LGX818|LGX818 will be administered orally, once daily on a continuous dosing schedule (28-day cycle).
16150417|NCT01777763|Drug|Posaconazole 200 mg|
16150418|NCT01777763|Drug|Posaconazole 300 mg|
16150419|NCT01777750|Device|EMCOOLS flex pad; Philips Innercool RTx|Surface cooling with EMCOOLS flex pads (out-of-hospital); Infusion of 1000ml to 2000ml of cold saline (out-of-hospital); central-venous cooling (Philips Inntercool RTx)
16150420|NCT01777737|Drug|Cotrimoxazole|24 weeks of treatment
16150421|NCT01777737|Drug|Placebo|Identical capsules to cotrimoxazole
16150422|NCT01777724|Behavioral|Combination of Triple P Discussion Groups and Stress Control|The intervention consists of eight group sessions: two 120 minute Triple P Discussion Group sessions (http://www.triplep.net/), and six 90 minute Stress Control sessions (http://glasgowsteps.com/home.php).
16150423|NCT01777711|Behavioral|Mental Contrasting- Individual|Investigators will implement the manipulation of mental contrasting/implementation intentions, focusing on the individual. This will entail 3 steps that involve: 1) contrasting of positive future outcomes associated with present conditions that hinder achievement of positive future outcomes (i.e., barriers); 2) strategies to overcome barriers and hence facilitate weight loss; and 3) construction of implementation intentions.
16150424|NCT01777711|Behavioral|Mental Contrasting- Couple|Investigators will implement the manipulation of mental contrasting/implementation intentions, focusing on the couple. This will entail 3 steps that involve: 1) contrasting of positive future outcomes associated with present conditions that hinder achievement of positive future outcomes (i.e., barriers); 2) strategies to overcome barriers and hence facilitate weight loss; and 3) construction of implementation intentions.
16150425|NCT01777685|Drug|Sulpiride|
16150426|NCT01777672|Behavioral|Dietary and oral hygiene recommendations|
16150427|NCT01777672|Dietary Supplement|oral TRPV1 agonist|Patients will receive the administration of a TRPV1 agonist (natural capsaicin) supplement before each meal, 3 meals/day, 5 days/week for 2 consecutive weeks. The TRPV1 agonist will be provided by the pharmacy of the center.
16150428|NCT01777672|Device|pharyngeal electrical stimulation|Includes neuron stimulation treatment of 1 session / day of pharyngeal electrical stimulation of 10 min duration, 3 days/week during 1 week, done at the same center.
16150429|NCT01777672|Device|transcutaneous electrical stimulation|Trans-cutaneous electrical stimuli will be applied 5 seconds every minute during 1 hour daily session, 5 days/week during 2 consecutive weeks at the same centre.
16150430|NCT01777659|Device|Transcutaneous electrical nerve stimulation|Patients will be treated with conventional TENS (ENDOMED 684 Device, ENRAF-Nonius B.V., Rotterdam, Netherlands) for 5 days (4 times/day; 30 min/session) applied on cervical region (C7-T4). TENS intervention was applied as described elsewhere.
16150431|NCT01777646|Biological|MSC_NTF cells transplantation by multiple intramuscular injections at 24 separate sites, in addition to a single intrathechal injection into the CSF|
16150432|NCT01777633|Radiation|Palliative re-irradiation for progressive DIPG in children|
16150433|NCT01777620|Biological|onabotulinumtoxinA|BOTOX® (onabotulinumtoxinA) injected into the areas of glabellar lines and crow's feet lines on Day 1.
16150434|NCT01777620|Drug|Normal Saline|Placebo (normal saline) injected into the areas of glabellar lines and crow's feet lines on Day 1.
16150435|NCT01777607|Device|IMPELLA® RP|
16150436|NCT01777594|Drug|G-202|G-202 administered by intravenous infusion (IV, in the vein) on Days 1, 2 and 3 of each 28-day cycle until progression or development of unacceptable toxicity
16150437|NCT01777581|Drug|Milnacipran|
16150438|NCT01777581|Drug|Placebo|
16150439|NCT01777568|Drug|30% oxygen|Inspired oxygen will be maintained at 30%.
16150440|NCT01777568|Drug|80% oxygen|Inspired oxygen will be maintained at 30%.
16150441|NCT01777555|Drug|CVT-301|
16150442|NCT01777555|Drug|Placebo|
16150443|NCT01777542|Drug|Recombinant Human Insulin Growth Factor 1 (rhIGF-1)|Subjects will receive twice daily subcutaneous injections of IGF-1.
16150444|NCT01777542|Drug|Placebo|Subjects will receive twice daily subcutaneous injections of a saline solution (placebo).
16150445|NCT01777529|Biological|MMR Vaccine|Administration of MMR Vaccine by Bio-Manguinhos or MMR Vaccine by GlaxoSmithKline
16150446|NCT01777503|Drug|prasugrel|prasugrel 5 mg o.d.
16150447|NCT01777503|Drug|Clopidogrel|75 mg o.d.
16150448|NCT01777490|Behavioral|Helping Invested Families Improve Veterans Experiences - Control|Usual care will be the Veteran patient care and caregiver support that are normally offered once the Geriatrics and Extended Care (GEC) referral process has occurred. This process entails the patient and caregiver work with the social worker assigned to the patient to obtain home and community based care (HCBC) services. The patients in the usual care group will be free to seek medical, psychological, social support, and social services that are available through VAMCs or any other source. In addition to this, caregivers in the usual care arm will be told about the caregiver support programs in the VHA and the caregiver will receive the national VA caregiver hotline phone number. The information provided mirrors efforts to support caregivers in the VA nationally and new standards of care for VA caregivers. This will be the only contact with the usual care subjects besides the scheduled data collection assessments.
16150449|NCT01777490|Behavioral|Helping Invested Families Improve Veterans Experiences - HI FIVES|In addition to the usual care activities outline in the Control arm, Caregivers in the HI-FIVES group will receive three individual calls with a nurse educator to address topics he/she identified as being the highest priority learning areas. The calls will be tailored to the individual needs of Veteran-caregiver dyad. After the phone calls, caregivers will participate in four evidence-based group sessions aimed to improve clinical care skills, psychological care skills, and support-seeking skills. The curriculum will be delivered by a trained nurse educator and the PI and VA Caregiver Support Staff. The sessions will be targeted to address common needs of Veterans and their caregivers. After the final group session, there will be two optional booster calls at one and three months. Four assessments in all will be collected, baseline (in person), and at 3, 9, and 15 months (by phone).
16150450|NCT01777477|Drug|Chloroquine|Addition of Chloroquine to Gemcitabine
16150451|NCT01777477|Drug|Gemcitabine|
16150452|NCT01777464|Biological|histamine|administration of histamine solution (16 mg/ml) via aerosol for 5 minutes while lying under a fMRI scan
16150453|NCT01777464|Biological|sham|sham solution
16150454|NCT01777451|Other|Additional imaging or surgery|No specific intervention is necessary. If a suspicious lesion is diagnosed on MRI, further investigation will be planned (PET-CT or surgery - biopsy)
16150456|NCT01777386|Procedure|preexpanded perforator flap surgery|
16150457|NCT01777360|Device|ALAIR, radiofrequency catheter for bronchial THERMOPLASTY|radiofrequency catheter for bronchial THERMOPLASTY
16150458|NCT01777347|Drug|3% Saline|Two 4 mL nebulization of 3% saline with 20 minutes interval
16150459|NCT01777347|Drug|0.9% Normal Saline|Two 4 mL nebulization of 0.9% normal saline with 20 minutes interval
16150460|NCT01777334|Drug|Umeclidinium/Vilanterol 62.5/25 mcg|Inhalation Powder
16150461|NCT01777334|Drug|Tiotropium 18 mcg|Inhalation Powder
16150462|NCT01777321|Biological|Herpes zoster vaccine GSK1437173A|HZ/su vaccine administered either into the subcutaneous tissue of the upper arm (deltoid region) of the non-dominant arm or intramuscularly in the deltoid region of non-dominant arm on a 0,2-month schedule.
16150463|NCT01777308|Biological|Meningococcal conjugate vaccine GSK134612|Single dose to be administrated intramuscularly in the deltoid of the non-dominant arm
16150464|NCT01777295|Biological|Adjuvanted Hepatitis B surface antigen (HBsAg) candidate vaccine GSK2231392A.|Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
16150465|NCT01777295|Biological|EngerixTM-B|Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
16150466|NCT01777295|Biological|Placebo|Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
16150467|NCT01777282|Drug|Albiglutide|Albiglutide is a fixed-dose, fully disposable pen injector system for delivery of albiglutide from a prefilled dual chamber glass cartridge that is an integral part of the pen. It is intended for single use by the subject. It is designed for manual reconstitution of the dose, priming, and insertion of the pen needle, and manual injection by the subject. The subject will inject albiglutide 30 mg weekly for 52 weeks (with optional uptitration to 50 mg weekly) subcutaneously into the abdomen, alternating between left and right sides. The pen is designed to work with standard pen needles.
16150468|NCT01777282|Drug|Sulfonylurea|Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
16150469|NCT01777282|Drug|Biguanide|Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
16150470|NCT01777282|Drug|Glinide|Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
16150471|NCT01777282|Drug|Thiazolidinedione|Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
16150472|NCT01777282|Drug|Alpha-glucosidase inhibitor|Single oral antidiabetic drug as a background therapy, to be continued as previously prescribed.
16150473|NCT01777269|Drug|Dutasteride plus tamsulosin|Take 1 capsule daily
16150474|NCT01777269|Drug|Placebo|Take one capsule daily
16150475|NCT01777256|Drug|GSK2586184 50 mg|GSK2586184 tablet will be administered orally as twice daily dose of 50 mg (1 x 50 mg tablet) up to 12 weeks.
16150476|NCT01777256|Drug|GSK2586184 100 mg|GSK2586184 tablet will be administered orally as twice daily dose of (2 X 50 mg tablet) up to 12 weeks.
16150477|NCT01777256|Drug|GSK2586184 200 mg|GSK2586184 tablet will be administered orally as twice daily dose of 200 mg (1 x 200 mg) up to 12 weeks.
16150478|NCT01777256|Drug|GSK2586184 400 mg|GSK2586184 tablet will be administered orally as twice daily dose of (2 X 200 mg) up to 12 weeks.
16150479|NCT01777256|Drug|Placebo|Matching placebo tablet will be administered orally twice daily up to 12 weeks.
16150480|NCT01777243|Drug|GSK2398852|Unit dose strength: 100 mg/mL provided as 1 mL solution per vial. GSK2398852 dosage levels variable with the proposed starting dose level of GSK2398852 as 5 mg [approximately equivalent to 0.1 mg/ kg]. The next escalation dose levels are proposed as 1 mg/kg, 3 mg/kg, 10 mg/kg and 30 mg/kg.
16150481|NCT01777243|Drug|GSK2315698|Unit dose strength: 200 mg/mL stock to be diluted. GSK2315698 will be administered at variable dosed until the concentration of the serum amyloid P component monoclonal antibody (SAP mAb) has fallen below 100 ng/mL.
16150482|NCT01777230|Procedure|SPECT-CT sentinel node mapping|sentinel node localisation using the nuclear medicine technique SPECT-CT
16150483|NCT01777230|Procedure|Magnetic Resonance Lymphangiography sentinel node mapping|Sentinel node localisation using Magnetic Resonance Lymphangiography
16150484|NCT01777230|Procedure|Intra-operative sentinel node procedure|Open or (robot-assisted) laparoscopic sentinel node detection and resection.
16150485|NCT01777217|Drug|Solifenacin succinate|IGRT with VESIcare
16150486|NCT01777217|Drug|Placebo|IGRT with placebo
16150487|NCT01777191|Drug|Ixekizumab Auto-Injector|Administered SC by auto-injector
16150488|NCT01777191|Drug|Ixekizumab Prefilled Syringe|Administered SC by prefilled syringe
16150489|NCT01777178|Other|Low bicarbonate dialysis|
16150490|NCT01777165|Drug|ABT-719|1 arm of ABT-719 higher dose, 1 arm of ABT-719 intermediate dose, and 1 arm ABT-719 lower dose
16150491|NCT01777165|Drug|Placebo|Placebo infusion
16150492|NCT01777152|Drug|brentuximab vedotin|1.8 mg/kg every 3 weeks by IV infusion for 6-8 cycles
16150493|NCT01777152|Drug|doxorubicin|50 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
16150494|NCT01777152|Drug|prednisone|100 mg on Days 1 to 5 of each 3-week cycle, orally for 6-8 cycles
16150495|NCT01777152|Drug|vincristine|1.4 mg/m2 (maximum 2 mg) every 3 weeks by IV infusion for 6-8 cycles
16150496|NCT01777152|Drug|cyclophosphamide|750 mg/m2 every 3 weeks by IV infusion for 6-8 cycles
16150497|NCT01777139|Drug|Retigabine IR|Retigabine IR tablets will be available in 5 strengths: 50 mg, 100 mg, 200 mg, 300 mg, and 400 mg.
16150498|NCT01777126|Other|Oral Nutrition Protocol (ONP) group|For the experimental group, an oral nutrition protocol (ONP) with restrictive instructions for parenteral nutrition is implemented. Oral intake is increased progressively with oral fluids and easily digestible food, independent of clinical bowel movements. The oral energy sips used are Fortimel Jucy® (Nutricia) 200 ml containing 300 kcal. This provides supplementary energy and essential nutrients. Supplementary fluid, approximately up to two liter, is given intravenously. Only if oral intake is still insufficient after five days, PN (Oliclinomel N7) can be initiated.
16150499|NCT01777126|Other|Control group|Subjects enrolled in this arm will undergo usual medical and pharmaceutical care. In this group, parenteral nutrition (Oliclinomel N7) is part of the routine postoperative care program.
16150526|NCT01776840|Drug|Placebo|4 capsules administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or the final analysis of progression-free survival
16150500|NCT01777113|Other|High intensity aerobic training|The mode of the training will be uphill treadmill walking in 4x4 minute intervals at 85% and 95% of Heart Rate Peak (HRpeak) precede by 10-minute warm-up period on the treadmill at self-selected speed and inclination. Between the 4-minute intervals, 3-minute active breaks walking at approximately 50% of HRpeak will be applied. The training sessions will be terminated by a 3-minute cool-down period at 50% to 70% HRpeak. To compensate for increased VO2peak, the speed and/or inclination will be gradually adjusted during 3-month intervention to make sure that the target HR will be between 85% and 95% of HRpeak during the high-intensity intervals.
16150501|NCT01777113|Other|High Intensity Strength Training|Five warm-up repetitions will be completed at approximately 50% of 1 repetition maximum before the main session of four sets of four repetitions unilaterally at 85%Y95% of 1 repetition maximum for both leg press and plantarflexion. When subjects will be able to complete a fifth repetition, the weight will be increased by 1.25 to 2.5 kg, dependent on subjective feelings of capability. They will be encouraged to focus of an explosive concentric movement and a controlled eccentric movement such that the time on each phase will be in the ratio 1:2. The subjects will be regularly reminded to focus on breathing during the contraction, preventing the valsalva maneuver and high rises in blood pressure. The session will finish with a minimum 5-min warm down the treadmill device.
16150502|NCT01777113|Other|Mixed Training|Conventional training consisted of group mobility, balance and stretching exercises. Mobility training included treadmill and cycloergometer training for 10 minutes at self selected speed. Exercises at the parallel bars included weight shift from leg to leg, half-squat, turn in place, leg-trunk flexion, and extension exercises. Finally seated upper- and lower-limb stretching exercises will focus on range of motion, including trunk mobility.
16150503|NCT01777100|Drug|Sufentanil|Sufentanil 0.5 mcg.kg-1 at anesthesia induction (single dose)
16150504|NCT01777087|Other|gauze soaked with capsaicin|This is a basic science study determining the brain activation that results from painful stimulation. All subjects will have the same painful stimulations and brain images collected.
16150505|NCT01777074|Other|Data collection|Questionnaire, Vaccination book
16150506|NCT01777061|Drug|[11C]Acetate|intravenous injection of an average of 40 mCi of [11C]Acetate
16150507|NCT01777048|Dietary Supplement|Omega-3 Fatty Acids Supplementation|
16150508|NCT01777048|Dietary Supplement|Omega-3 Placebo|Placebo capsules manufactured to mimic Omega-3 capsules
16150509|NCT01777035|Other|early PT OT|"Passive range of motion (ROM) in pts who remain unresponsive despite sedative interruption.
~active assisted ROM in supine position.
~treatment is advanced to bed mobility activities
~sitting balance activities followed by participation in activities of daily living (ADLs) and exercises that encourage increased independence with functional tasks.
~progression to transfer training, and finally pre-gait training and ambulation.
~progression of activities dependent on patient tolerance and stability
~therapy sessions continue on a daily basis throughout hospital stay until return to prior level of function or is discharged."
16150510|NCT01777022|Other|A package of interventions|"A package of interventions consisting of strategies for increasing pregnant women's awareness of the need to report early when they perceive a reduction in fetal movements, followed with a management plan for identification and delivery of the at risk fetus in such women, will reduce rates of stillbirth"
16150511|NCT01777009|Procedure|Primary Total Knee Replacement Surgery|Patients randomized to the eversion group had patellas everted during the flexion portions of the surgery. Patients randomized to the retraction group had patellas everted only for the patellar resurfacing portions of the surgery. Both groups were mobilized with anterior tibial translation. All other aspects of surgery including postoperative care, anticoagulation, pain control, and physical therapy were done as per standard arthroplasty protocols at our institution.
16150512|NCT01776996|Drug|Continued Access Arm|All subjects will be on maraviroc 300 mg twice a day, unless a dose adjustment is required due to certain concomitant medications. For those subjects in South Africa and Argentina who were previously receiving Combivir along with maraviroc in Study A4001026, Combivir will be supplied as tablets containing 150 mg lamivudine and 300 mg zidovudine. One Combivir tablet will be taken orally twice a day.
16150513|NCT01776983|Device|Photosensitivity under the influence of immunocomp|Siascopy measurement of reflected light
16150514|NCT01776970|Drug|Cannabis Sativa extract Oromucosal spray|Comparison between active drug (Cannabis Sativa extract Oromucosal spray, containing THC (27 mg/ml):CBD (25 mg/ml) vs placebo
16150515|NCT01776957|Device|Device: Intrauterine device (IUD)|Women choosing to have an intrauterine device (IUD) inserted immediately post-abortion
16150516|NCT01776931|Dietary Supplement|Lysine intake|Oral consumption of Eight hourly experimental meals- Includes 4 tracer-free experimental meals containing a mixture of free amino acids, calories from a flavored liquid and protein free cookies and 4- labeled amino acid experimental meals.
16150517|NCT01776892|Drug|Collegenase injection|"Collagenase clostridium histolyticum will be used to treat participants in this arm of the study. Affected cords will be treated with 1-3 collagenase injections at 4 week intervals, based on clinical response of the contracture. Cords will be treated until motion of the joint is within 0-5 degrees of normal, for up to 3 total injections.
~Metacarpophalangeal cords will be injected with 0.58mg (10 000 units) of collagenase in 0.25ml of sterile diluent. Proximal interphalangeal cords will be injected with 0.58mg (10 000 units) of collagenase in 0.20ml of sterile diluent."
16150518|NCT01776892|Procedure|Needle aponeurotomy|Percutaneous needle aponeurotomy will be performed using an 18 gauge needle. The needle is inserted through the skin into the Dupuytren's cord. The needle is moved very slowly through the cord until complete rupture of the cord is obtained.
16150519|NCT01776866|Procedure|Coronary Angiography|Coronary angiography include standard coronary angiography (SA) and dual-axis rotational coronary angiography (DARCA). Patient first undergo SA of either left or right coronary system followed by DARCA.
16150520|NCT01776853|Dietary Supplement|Glucose|
16150521|NCT01776853|Dietary Supplement|Fructose|
16150522|NCT01776853|Dietary Supplement|Fructans|
16150523|NCT01776840|Drug|Bendamustine|90 mg/m2 administered intravenously on Days 1-2, Cycles 1-6
16150524|NCT01776840|Drug|Rituximab|375 mg/m2 administered intravenously on Day 1, Cycles 1-6; if complete response or partial response is achieved, 375 mg/m2 is administered on Day 1 of every second cycle for a maximum of 12 additional doses
16150525|NCT01776840|Drug|Ibrutinib|560 mg (4 x 140 mg capsules) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end
16150527|NCT01776801|Other|Infusion|Infusion studies are performed in daily clinical routine to measure cerebrospinal fluid resistance outflow. During this test ICP is slowly and securely raised. Investigators plan to analyze what are the consequences of this ICP rise in terms of autonomic system and hemodynamics.
16150528|NCT01776788|Drug|insulin lispro injection, exenatide injection|First, Patients in the exenatide group will receive short-term continuous subcutaneous insulin (CSII)therapy. The doses will be titrated every day in order to attain the glycaemic goal which is defined as a fasting capillary blood glucose of less than 6.1 mmol/L and capillary blood glucose at 2 h after each of three meals of less than 8.0 mmol/L. Treatments will be maintained for 2 weeks after the glycaemic target will be reached. Then, patients will Sequential be treated with 5 mcg bid for 4 weeks and then 10 mcg bid for 8 weeks. After interventions will be stopped, patients will be instructed to continue diet and physical exercise only and will be followed-up with glycaemic monitoring monthly
16150529|NCT01776788|Drug|insulin lispro injection|Patients in the control group will receive insulin with an insulin pump. The doses will be titrated every day in order to attain the glycaemic goal. Treatments will be maintained for 2 weeks after the glycaemic target will be reached. Then interventions will be stop, patients will be instructed to continue diet and physical exercise only and will be followed-up with glycaemic monitoring monthly.
16150530|NCT01776775|Device|Abdominal binder|"The abdominal binder is worn from immediately after the operation and continuously for 7 days and nights. The belts are standard abdominal binders (ostomy belts) from ETO garments© with standard height of 22 cm. and five different sizes in width (S, M, L, XL, XXL- depending on waist measure). A fitting will be done for all included patients before the operation by waist measurement according to the recommendation from the company (see below). When applied, the patients are advised to apply the belt in a lying position."
16150531|NCT01776762|Dietary Supplement|Individual nutritional therapy|Individual nutritional therapy provided by registered dietician by means of three Home-visits
16150532|NCT01776749|Device|SubQ|Spinal Cord Stimulation (SCS) and subcutaneous (SubQ) stimulation SCS trial stimulation: Implantation of the Octad lead in the epidural space. The lead implantation in the epidural space is performed under local anesthesia using a standard percutaneous technique. A key element to the technical success of an SCS procedure is the accurate placement of the lead, which results in paresthesia covering the patients' painful areas. This depends on the patients' feedback during intra-operative testing. Therefore, it is important that the patient is awake and fully cooperative during the trial stimulation.
16150533|NCT01776736|Device|Posture Correction Girdle|Posture Correction Girdle applied for 8 hours per day. Clinical, radiographic, and self-report follow-up within the girdling period (6 months).
16150534|NCT01776723|Drug|Ruxolitinib|In Phase I, participants will be allocated to twice a day (BID) doses of 10 mg/d up to 40mg/d. The starting dose will be 10 mg/d (5mg BID). Each cohort will include up to 6 subjects. Once MTD is reached, 10 additional participants will be treated during the first stage of Phase II (stage 1) at the MTD.
16150535|NCT01776710|Behavioral|Structured education|The structured education intervention will comprise a 3-hour education workshop delivered by two trained facilitators and a follow-up telephone call 2 weeks later. The aims of the education programme are to enhance patients' understanding of peripheral arterial disease and intermittent claudication, and to support patients in increasing their daily walking activity. Key behaviour change techniques that will be incorporated will include goal setting, action planning, barrier identification/problem solving, prompt review of behavioural goals, prompt self-monitoring of behaviour, and instructions on how to perform the behaviour.
16150536|NCT01776697|Drug|pelubiprofen (30mg) tablet IR|
16150537|NCT01776697|Drug|pelubiprofen SR (as a pelubiprofen 90 mg) tablet|
16150538|NCT01776684|Drug|EGFR TKIs (gefitinib, erlotinib, afatinib, et al)|
16150539|NCT01776671|Drug|Gralise|Titration starting 300 mg/day up to 1800 mg/day over 2 weeks
16150540|NCT01776658|Drug|SYL1001|Ocular topical administration of SYL1001 for 10 consecutive days
16150541|NCT01776658|Drug|Placebo|Ocular topical administration of placebo for 10 consecutive days
16150542|NCT01776645|Behavioral|Compassion Cultivation Training Course|
16150543|NCT01776632|Behavioral|Physical activity|Promotoras led 6 free physical activity (PA) classes per week (2 walking groups, 2 cardio dance, and 2 strength training) at participating churches randomized to the intervention condition. Classes included prayer, warm-up, moderate-to-vigorous PA, cool-down, followed by discussion of a monthly health handout. Participants received copies of the handouts each month by mail, which promoted healthy PA habits. Promotoras conducted up to 5 motivational interviewing calls with each participant over the 2-year intervention using a guide to evaluate participants' PA engagement, barriers to being active, and solutions to those barriers. Promotoras advocated for changes to the social and built environments of the churches and surrounding neighborhoods in order to promote PA and healthy behaviors.
16150544|NCT01776632|Behavioral|Cancer screening|Promotoras provided a 6-session group-based workshop series on cancer screening and prevention (breast, cervical, colorectal, and skin cancers) at participating churches randomized to the attention-control condition. Participants received informational handouts developed by American Cancer Society and the National Cancer Institute to reinforce learning in addition to lists of local cancer screening resources. Promotoras conducted up to 4 motivational interviewing calls with each participant over the 2-year intervention to encourage screening, help overcome barriers to screening, and provide support for goals.
16150545|NCT01776619|Drug|PF-06305591|14 day repeated 20mg BID doses
16150546|NCT01776619|Drug|Placebo|14 day repeated BID doses
16150547|NCT01776619|Drug|PF-06305591|14 day repeated 80mg BID doses
16150548|NCT01776619|Drug|Placebo|14 day repeated BID doses
16150549|NCT01776619|Drug|PF-06305591|14 day repeated 40mg BID doses
16150550|NCT01776619|Drug|Placebo|14 day repeated BID doses
16150551|NCT01776619|Drug|PF-06305591|14 day repeated BID doses
16150552|NCT01776619|Drug|PF-06305591|relative bioavailability tablet vs. solution and food effect at 50mg dose
16150553|NCT01776606|Drug|Botulinum Toxin Type A|Botulinum Toxin Type A, Dose A; dose applied to the lateral canthal lines
16150554|NCT01776606|Drug|Placebo|Placebo, Dose B; dose applied to the lateral canthal lines
16150555|NCT01776567|Device|Everolimus eluting stents|
16150556|NCT01776554|Biological|Adjuvanted H5N1 pandemic influenza vaccine|Comparison of two doses of aH5N1c vaccine
16150557|NCT01776541|Biological|Adjuvanted H5N1 pandemic influenza vaccine|Comparison of two doses of aH5N1c vaccine
16150560|NCT01776515|Drug|Tramadol hydrochloride/Acetaminophen Tab.|
16150561|NCT01776515|Drug|Tramadol hydrochloride/Acetaminophen SR Tab.|
16150562|NCT01776463|Drug|Z-360|
16150563|NCT01776463|Drug|placebo|
16150564|NCT01776450|Device|Endovascular AAA repair|
16150565|NCT01776437|Drug|BMN 673|500mcg dose of BMN 673, 2 discrete single doses separated by 21 days
16150566|NCT01776424|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Rivaroxaban 2.5 mg twice daily, tablet
16150567|NCT01776424|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Rivaroxaban 5.0 mg twice daily, tablet
16150568|NCT01776424|Drug|Aspirin|Aspirin 100 mg once daily, tablet
16150569|NCT01776424|Drug|Aspirin placebo|Placebo(1), matching Aspirin tablets
16150570|NCT01776424|Drug|Rivaroxaban placebo|Placebo(2), matching Rivaroxaban tablets
16150571|NCT01776424|Drug|Pantoprazole|Subjects who are not on a proton pump inhibitor (PPI) will also be randomized to pantoprazole or pantoprazole placebo
16150572|NCT01776411|Drug|forodesine hydrochloride|
16150573|NCT01776385|Other|Blood sampling|Biological: ISET and CellSearch Methods Sampling of blood - ISET and CellSearch Methods
16150574|NCT01776385|Other|Control Group|Biological: ISET and CellSearch Methods Sampling of blood - ISET and CellSearch Methods
16150575|NCT01776372|Device|Medela Thopaz Thoracic Drainage System|
16150576|NCT01776372|Device|Atrium Express Dry Seal Chest Drain|
16150577|NCT01776359|Dietary Supplement|High Protein|2.4g/kg of protein
16150578|NCT01776359|Dietary Supplement|Low Protein|1.2g/kg of protein
16150579|NCT01776333|Behavioral|video decision aid|
16150580|NCT01776320|Drug|Alprostadil|One unit of Vitaros(330ug of Alprostadil)once a week or once every two weeks for four or eight weeks.
16150581|NCT01776307|Drug|BBI608|BBI608 is administered at 500 mg po bid continuously.
16150582|NCT01776307|Drug|Panitumumab|Panitumumab will be administered IV on day 8 and 22 of each 28 day cycle at 6 mg/kg over 60 minutes.
16150583|NCT01776307|Drug|Capecitabine|Capecitabine will be administered orally at 1000 mg/m2 bid daily on days 8-21 every three weeks.
16150584|NCT01776307|Drug|Cetuximab|Cetuximab will be administered IV on day 5 at 400 mg/m2 intravenous infusion over 120 minutes as the initial dose, then weekly at 250mg/m2 over 60-minutes at subsequent cycles.
16150585|NCT01776281|Behavioral|Kangaroo Mother Care|
16150586|NCT01776281|Behavioral|Standard Care|
16150587|NCT01776268|Other|Oral priming|Mother's own colostrum is administered (0.1 mL to each cheek every 6 hours for 5 days) as soon as it is available from the mother regardless of when enteral feedings are initiated.
16150588|NCT01776255|Behavioral|Healthy Children, Strong Families|"Healthy Children, Strong Families is a series of 13 lessons mailed to primary caregivers of preschool aged children that provide education and activities related to obesity prevention. The lessons cover topics related to nutrition, physical activity, stress, sleep, and the home environment. Lessons include printed materials and small items (for example, an apple sectioner) that support activities in the lessons. Social support components via a monitored Facebook group and approximately semiweekly text messages sent to caregivers are included. The intervention spans 1 year."
16150589|NCT01776255|Behavioral|Child Safety|The Child Safety intervention is an active control condition consisting of monthly two-page newsletters covering various topics relevant to child safety such as choking, car safety seats, bike and pedestrian safety. The intervention spans 1 year.
16150590|NCT01776229|Behavioral|Exposure, Relaxation, & Rescripting Therapy-Child|Exposure, Relaxation, & Rescripting Therapy (ERRT) will be conducted once a week for five consecutive weeks for approximately two hours per session. Each treatment session focuses on one of the following topics/skills: psycho-education and investment in treatment, psycho-education, Progressive Muscle Relaxation, diaphragmatic breathing,child-friendly exposure to the trauma-nightmare, and rescription.
16150591|NCT01776216|Other|Dairy diet|During the DAIRY diet, subjects will be asked to incorporate 3 servings of dairy: 375 ml of reduced fat milk (1% fat), 175 g of low fat yogurt (1.5% fat) and 30g of regular cheese (34% fat) into their every day diet.
16150592|NCT01776216|Other|Control diet|During the CONTROL diet of the study, participants will be asked to consume energy equivalent replacement products (290 ml of fruit juice, 156 ml of vegetable juice, 1 homemade cookie, 20g of cashew).
16150593|NCT01776203|Drug|Medroxyprogesterone 17-Acetate|MPA pills 20 mg (2 X 10 mg) twice daily for 3 weeks
16150594|NCT01776190|Device|UVA1 radiation treatment|
16150595|NCT01776138|Other|Collect Blood and Survey Instruments|
16150596|NCT01776125|Other|Cheek swab|Participants will be asked to give us a swab (a long Q-tip) of the inside of your cheek (inside your mouth) for genetic testing. This should take no more than 10 seconds. It will not hurt. The swab kit will be provided by Affiliated Genetics. It will include a self-addressed stamped envelope to mail the swab back to Affiliated Genetics. Participants existing x-rays will be reviewed as part of this study as well. We will review participant's medical record to look at what treatments have been executed during the course of participation. Once the individual agrees to participate in this project their private health information will be sent to Axial Biotech Inc., the company that will be doing the genetic testing.
16150597|NCT01776112|Other|Exercise|Standard treatment and participation in the sports program (cycling) including cognitive training, 3 sessions cycling (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks.
16150598|NCT01776112|Other|TableSoccer|Standard treatment and participation in an activity without physical improvement as placebo condition (table football in groups of 4), but including cognitive training, 3 sessions (30 min. each) per week for 3 months and 2 sessions Cogpack per week for the last 6 weeks.
16150599|NCT01776099|Dietary Supplement|Dietary supplement (4 arms, 2 active, 2 placebo)|
16150600|NCT01776086|Behavioral|Neurological testing|
16150601|NCT01776073|Behavioral|Patient Navigation|
16150602|NCT01776060|Other|generation of 'omic markers of disease progression|Aside from first in disease sampling, the serial, biannual collection of samples from PPMS patients would not only permit the identification of 'omic profiles that can be compared and contrasted to those from RRMS patients in a parallel study, but it would also allow the generation of 'omic markers of disease progression.
16150603|NCT01776047|Drug|Exforge®|
16150604|NCT01776047|Drug|G-0081|
16150605|NCT01776034|Behavioral|SystemCHANGE Group Lifestyle counseling|
16150606|NCT01776034|Behavioral|Phone Lifestyle Counseling|
16150607|NCT01776021|Other|cranberry juice|cranberry juice beverage at a dose of one 8 oz. beverage per day for six months
16150608|NCT01776021|Other|placebo beverage|placebo beverage at a dose of one 8 oz. beverage per day for six months
16150609|NCT01776008|Drug|Akt Inhibitor MK2206|Given PO
16150610|NCT01776008|Drug|Anastrozole|Given PO
16150611|NCT01776008|Drug|Goserelin Acetate|Given SC
16150612|NCT01776008|Other|Laboratory Biomarker Analysis|Correlative studies
16150613|NCT01776008|Procedure|Neoadjuvant Therapy|Given before standard-care surgery
16150614|NCT01776008|Other|Pharmacological Study|Correlative studies
16150615|NCT01776008|Procedure|Therapeutic Conventional Surgery|Undergo standard-care surgery
16150616|NCT01775995|Behavioral|Meditation-CBT Intervention + Usual Care|"The intervention combines meditation and standard-of-care CBT strategies for chronic low back pain. It consists of eight weekly 2-hour group sessions guided by trained instructors. In addition to session attendance, experimental participants are asked to practice meditation at home at least 6 days/week, 30 minutes/day during the 26-week study.
~Control participants will be offered the intervention after completing the study.
~All participants receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations."
16150617|NCT01775995|Other|Usual Care Alone|All participants receive usual care for opioid-treated CLBP through their regular clinicians, per their recommendations.
16150618|NCT01775982|Other|Psychiatric evaluation|"This evaluation is carried out in several stages:
~Assessment of cognitive functioning;
~Interview with a relative;
~Interview with caregivers;
~Evaluation of the presence of delirium according to DSM-IV criteria;
~Evaluation of the presence of anxiety, depressive syndrome, dementia or other DSM IV;
~Reports of adverse events.
~A potential intervention order effect will be taken into account by balancing in each center the number of evaluations beginning with the geriatric assessment and those starting with the psychiatric assessment."
16150619|NCT01775982|Other|Geriatric evaluation|"This evaluation includes a brief interview with a caregiver, diverse scorings (CAM, Delirium Index, Mini Geriatric Depression Scale, Modified Early Warning Score, Clinical Global Impression sclae, Algo Plus), and adverse event reporting.
~CAM scoring is carried out by a trained geriatrician and a trained nurse and/or a psychologist.
~A potential intervention order effect will be taken into account by balancing in each center the number of evaluations beginning with the geriatric assessment and those starting with the psychiatric assessment."
16150620|NCT01775969|Other|Text Message|A text message with instructions is sent to the patient
16150621|NCT01775969|Other|Voicemail|A voicemail with instructions is sent to the patient
16150622|NCT01775930|Drug|Carfilzomib|20 mg/m2 over 30 minutes by vein infusion on Days 1 and 2 and a dose of 56 mg/m2 over 30 minutes by vein infusion on Days 8, 9, 15, and 16 of each 4 week cycle.
16150623|NCT01775904|Drug|LY2886721 in a Capsule|Administered orally.
16150624|NCT01775904|Drug|LY2886721 in an orally disintegrating tablet (ODT)|Administered orally.
16150625|NCT01775891|Drug|pilsicainide|The dose of pilsicainide will be 50mg tid PO. Pilsicainide will be started on the night of the ablation for a duration of at least 3 months. Physicians were encouraged to stop the drugs following the 3 months treatment if possible.
16150626|NCT01775891|Drug|other class IC antiarrhythmic drug|Other class IC antiarrhythmic drug that they had been taking before catheter ablation will be administrated.(flecainide 100mg bid PO or propafenone 225mg tid) Antiarrhythmic drug will be started on the night of the ablation for a duration of at least 3 months. Physicians were encouraged to stop the drugs following the 3 months treatment if possible.
16150627|NCT01775878|Device|Telemonitoring Device|Telemonitoring device was installed in patients' homes
16150628|NCT01775865|Drug|Salsalate|4 weeks of daily salsalate
16150629|NCT01775865|Drug|Placebo (for salsalate)|4 week of daily placebo
16150630|NCT01775852|Behavioral|ACT-IM|1 hour discussion about migraine management (IM) and 5 hours of group therapy based on Acceptance and Commitment Therapy (ACT). IM covers symptoms and triggers for worsening of migraine symptoms, how to use migraine medications, medication overuse headache, etc. The ACT intervention includes: 1) Behavioral Change Training and; 2) Mindfulness and Acceptance Training emphasizing new ways of managing troubling thoughts, feelings, and physical sensations.
16150631|NCT01775839|Drug|Aspirin+Clopidogrel/Digoxin(oral)|oral administration of digoxin
16150632|NCT01775839|Drug|Aspirin+Clopidogrel/Digoxin(IV)|intravenous administration of digoxin
16150633|NCT01775826|Other|Measurement|Measured usual (day-to-day) behavior with body-worn sensors.
16150634|NCT01775813|Drug|Metformin|After randomization, the study drug (metformin or placebo) is gradually titrated to full dose of 1000 mg BID (or to maximum tolerated, at least 500 mg BID) over a period of 4 weeks to minimize adverse gastrointestinal effects. Participants are seen every three months to measure compliance and dispense new study drug. Every 6 months, they also have a physical examination in order to determine puberty staging. Study measurements (IVGTT, bloodwork, DXA) are performed at Tanner 4 puberty and Tanner 5 (puberty completion), at which time the study drug is stopped. Study measurements will be performed again 6 months after study drug is completed to assess if effects are persistent after study drug is stopped. During the treatment period, all participants receive standard lifestyle counseling.
16150635|NCT01775800|Other|Treatment modification|
16150636|NCT01775787|Drug|Nicotine with Tobacco Flavor and Tobacco & Menthol Flavor|Subjects randomized to either Tobacco Flavor group for 7-10 days than crossed over to Tobacco & Menthol Flavor for 7-10 days or Tobacco & Menthol Flavor group for 7-10 days than crossed over to Tobacco Flavor for 7-10 days
16150637|NCT01775774|Biological|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells|Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells will be administered intravenously.
16150638|NCT01775761|Drug|Period 1|A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval.
16150639|NCT01775761|Drug|Period 2|A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval.
16150640|NCT01775761|Drug|Period 3|A comparison of less than or equal to 960 mg tafamidis, 400 mg moxifloxacin and placebo on the rate corrected QT interval.
16150641|NCT01775748|Other|Active Concord Grape Juice 12 oz per day|Grape Juice 12 oz per day
16150642|NCT01775748|Other|Placebo Grape Juice 12 oz per day|Placebo Grape Juice 12 oz per day
16150643|NCT01775735|Device|Occipital nerve stimulator|Electrical stimulation of the greater occipital nerve
16150644|NCT01775722|Device|Pulsed Dye Laser|port wine stain
16150645|NCT01775722|Device|Combined Bipolar Radiofrequency&Pulsed Dye Laser|Combined Bipolar Radiofrequency&Pulsed Dye Laser Treatment
16150646|NCT01775709|Device|PE tube with Duckbill Valve|PE tube with Duckbill Valve
16150647|NCT01775670|Device|Off-the-shelf splint|Subjects will use an off-the-shelf splint
16150648|NCT01775670|Device|OT Splint|Subjects will use a splint custom-made by Massachusetts General Hospital Occupational Therapists.
16150649|NCT01775657|Device|Thopaz (Digital drainage)|
16150650|NCT01775657|Device|Pleur Evac (Analogue drainage)|
16150651|NCT01775644|Drug|Bevacizumab|Administration of treatment will be as used in normal daily routine under local labeling.
16150652|NCT01775631|Biological|Urelumab|
16150653|NCT01775631|Biological|Rituximab|
16150654|NCT01775618|Biological|BAY94-9027|Study drug dosing was adjusted to the clinical needs of each subject in the range of 25-60 IU/kg/administration, intravenous infusion, at least 50 EDs and a minimum of at least 6 months
16150655|NCT01775618|Biological|BAY94-9027|Twice per week prophylaxis: 25-60 IU/kg, intravenous infusion, for 12 weeks
16150656|NCT01775618|Biological|BAY94-9027|Study drug dosing was adjusted to the clinical needs of each subject in the range of 25-60 IU/kg/administration, intravenous infusion, at least 50 additional EDs to achieve at least 100 cumulative EDs, or until marketing authorization of the drug
16150657|NCT01775605|Drug|Synera|Synera Pain Patch
16150658|NCT01775592|Drug|Arterakin (DHA-PPQ)|
16150659|NCT01775579|Drug|Glucophage SR tablet 750 mg, Crestor tablet 20 mg|
16150660|NCT01775553|Drug|Carfilzomib|During Cycle 1, patients will receive either 20 mg/m2 on days 1,2 (if the subject has not received carfilzomib as part another clinical trial within the last 4 weeks) or 56 mg/m2 (if the subject is enrolling in the present study after progression of disease on carfilzomib within the last month - for example subjects enrolled in CMAP compassionate use carfilzomib). Thereafter, all subjects will receive 56 mg/m2 for the remaining doses given Cycle 1 Day 8 onwards. Each cycle is 28 days.
16150661|NCT01775540|Drug|Systane Ultra|Artificial tear Eyedrop, 1 drop used QID for 4 weeks
16150662|NCT01775540|Drug|Saline solution|Saline solution,1 drop used QID for 4 weeks
16150663|NCT01775540|Drug|Maxidex|Eyedrop-1 drop QID for 4 weeks
16150664|NCT01775527|Other|blood test|
16150665|NCT01775501|Drug|Leucovorin|200mg/m2 administered IV on Days 1 and 15 of a 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
16150666|NCT01775501|Drug|Fluorouracil|5-FU continuous infusion: 2400mg/m2 total (1200mg/m2/d on day 1 and 2) to start on Day 1 and Day 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
16150667|NCT01775501|Drug|Oxaliplatin|85 mg/m2 IV on Days 1 and 15 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
16150668|NCT01775501|Drug|Sorafenib|400mg po BID continuously for a 2 week lead-in phase and then Days 1-28 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
16150669|NCT01775488|Device|Vortx Rx - Histotripsy BPH Device|Non-invasive histotripsy treatment / therapy to be delivered by surgeon using very low duty cycle ultrasound pulses from outside the patient's body. These pulses form a bubble cloud at the focal area within the prostate which mechanically breaks up the cellular structure of the soft tissue. During treatment, a surgeon is able to direct the bubble cloud throughout the targeted volume using controls located on the device console and using the real-time ultrasound for visualization feedback and control of the bubble cloud location.
16150670|NCT01775475|Drug|cyclophosphamide|Given IV
16150671|NCT01775475|Drug|doxorubicin hydrochloride|Given IV
16150672|NCT01775475|Drug|vincristine sulfate|Given IV
16150673|NCT01775475|Drug|prednisone|Given PO
16150674|NCT01775475|Drug|lomustine|Given PO
16150675|NCT01775475|Drug|etoposide|Given PO
16150676|NCT01775475|Drug|cyclophosphamide|Given PO
16150677|NCT01775475|Drug|procarbazine hydrochloride|Given PO
16150678|NCT01775475|Other|laboratory biomarker analysis|Correlative studies
16150679|NCT01775462|Drug|EDI200|3 or 10 mg/kg of EDI200
16150680|NCT01775449|Behavioral|Polyamines depleted diet, associating Polydol® cans and predefined menus low in polyamines|
16150681|NCT01775436|Behavioral|FAmily-CEntered Advance Care Planning|"Two-60 to 90 minute sessions scheduled one week apart.
~Session 1: Respecting Choices Interview (R)to facilitate conversations and shared decision-making between the patient and surrogate about palliative care & prepare the surrogate to be able to fully represent the patient's wishes.
~Session 2: Five Wishes (C). Patient selects which person the patient wants to make health care decisions for him/her; the kind of medical treatment the patient wants; how comfortable the patient wants to be; how the patient wants people to treat him/her; what patient wants loved ones to know; and any spiritual or religious concerns the patient may have."
16150682|NCT01775436|Behavioral|Healthy Living Control|"Session 1: Developmental History: Goal: To take a non-medical developmental history. The RA-Control will conduct the session in a structured interview format. Administered with all medical questions removed to prevent any risk of contamination with the experimental condition.
~Session 2: Nutrition and Exercise: Assess nutritional status and provide advice for maintaining optimal nutrition to boost immune functioning. Administered by the RA Control and will be videotaped to control for what occurs in the FACE intervention."
16150683|NCT01775423|Drug|BBI608|
16150684|NCT01775410|Device|Wolverine System to perform atherectomy|
16150685|NCT01775397|Drug|Fidaxomicin|capsule
16150686|NCT01775397|Drug|Vancomycin|capsule
16150687|NCT01775397|Drug|Placebo|Capsule
16150688|NCT01775384|Dietary Supplement|Nutrasorb|from blueberry and green tea extracts (2,136 mg/d gallic acid equivalents)
16150689|NCT01775384|Dietary Supplement|Placebo|
16150690|NCT01775371|Device|Patient controlled analgesia (PCA)|Loading dose 0.1 mg/kg morphine and demand dose of 1 mg morphine available every 6 minutes
16150691|NCT01775371|Other|Usual Care|Usual opioid analgesia determined by the provider
16150692|NCT01775358|Drug|ALRN-5281 0.015 mg/kg|
16150693|NCT01775358|Drug|ALRN-5281 0.05 mg/kg|
16150694|NCT01775358|Drug|ALRN-5281 0.15 mg/kg|
16150695|NCT01775358|Drug|Placebo 0.015 mg/kg|
16150696|NCT01775358|Drug|Placebo 0.05mg/kg|
16150698|NCT01775345|Procedure|Isotonic exercises|"20 sessions of muscular force work by means of isotonic exercises, that to the beginning will consist of 2 series of 10 repetitions to 60, 65 and 70 % of a MR.
~Later, a gradual progression will be realized and the load will be increasing up to being able to realize, before the session 30: 2 series of 15 repetitions to 60, 65 and 70 %, of 1MR, 2 series of 10 repetitions to 75 and 80 % of 1MR and one series of 6 repetitions to 85 and 90 % of 1MR."
16150699|NCT01775345|Procedure|Isokinetic exercises|20 sessions of muscular force work by means of isokinetic exercises, that to the beginning will consist of 2 series of 10 repetitions to 150, 180 and 210 º / seg in the first session and it will be increasing in a progressive and gradual way up to being able to realize, before the last session: 3 series of 15 repetitions to 180 º, 210 º and 240 º / seg, 2 series of 10 repetitions to 120 º and 150 º / seg and 2 series of 6 repetitions of 60 º and 90 º / seg.
16150700|NCT01775345|Procedure|Isotonic and isokinetic exercises|20 sessions of muscular force work by means of isotonic and isokinetic exercises. To the beginning it will consist of 1 series of 10 repetitions to 150, 180 and 210 º / seg and 1 series of 10 repetitions to 60, 65 and 70 % of 1 MR. A gradual progression will be realized up to reaching, before the last session, a load of: 2 series of 15 repetitions to 180, 210 and 240 º / seg, 1 series from 10 to 120 and 150 º / seg and 1 series of 6 repetitions to 60 and 90 º / seg, and 1 series of 15 repetitions to 60, 65 and 70 %, of 1MR, 1 series of 10 repetitions to 75 and 80 % of 1MR and 1 series of 3 repetitions to 85 and 90 % of 1MR.
16150701|NCT01775345|Procedure|ST|Standard therapy: The 10 first rehabilitation sessions will be common (manual therapy, electrotherapy, proprioceptive reeducation, isometric exercises, bike exercise and cryotherapy)
16150702|NCT01775332|Other|Educational Intervention|A brochure and access to a website including videos that contain detailed information about pituitary disorders will serve as the educational intervention.
16150703|NCT01775319|Dietary Supplement|Biofortified wheat|Extrinsic label 67Zn (ZnSO4) 0.2mg 70Zn added to the IV dose
16150704|NCT01775319|Dietary Supplement|Fortified wheat|Extrinsic label 67Zn (ZnSO4) 0.2mg 70Zn added to the IV dose
16150705|NCT01775319|Dietary Supplement|Placebo|
16150706|NCT01775293|Device|Non-absorbable polypropylene mesh|"2 step procedures
~first step is insertion of Non-absorbable polypropylene mesh under the facial skin
~second step is pulling of Non-absorbable polypropylene mesh after 3 weeks of 1 step"
16150707|NCT01775280|Radiation|Injection of Ytttrium-90 microspheres into the hepatic artery|INjection of Y-90 particles into the hepatic artery using endovascular access
16150708|NCT01775267|Procedure|Associating liver partition and portal vein ligation for staged hepatectomy|
16150709|NCT01775267|Procedure|Portal vein embolization or ligation|
16150710|NCT01775228|Behavioral|Peer Support|Support (informational, emotional and appraisal) in the form of like persons (i.e. age, gender) who have undergone CABG surgery with successful outcomes (post-recovery at least one year); peer support was provided by telephone for 6 weeks post cardiac surgery recovery.
16150711|NCT01775215|Radiation|Cardiac I123-MIBG Scintigraphy|
16150712|NCT01775215|Other|Cardiac MRI|
16150713|NCT01775215|Other|Stress and rest Echocardiogram|
16150714|NCT01775215|Other|High Sensitivity Troponin I|
16150715|NCT01775215|Other|Brain Natriuretic Peptide|
16150716|NCT01775189|Drug|ALO-02 weight-matched placebo|crushed sugar spheres (powder) x 1 dose
16150717|NCT01775189|Drug|crushed ALO-02 30 mg/3.6 mg|crushed ALO-02 30 mg/3.6 mg capsule x 1 dose
16150718|NCT01775189|Drug|oxycodone weight-matched placebo|crushed lactose tablets (powder) x 1 dose
16150719|NCT01775189|Drug|crushed oxycodone IR 30 mg|Three (3) crushed immediate-release (IR) oxycodone 10 mg tablets x 1 dose
16150720|NCT01775150|Other|health education|Health education via text messaging
16150721|NCT01775137|Drug|TBM100|Tobramycin inhalation powder (TIP) 112mg/b.i.d
16150722|NCT01775124|Drug|Ranibizumab|Intravitreal injections of 0.5 mg Ranibizumab
16150723|NCT01775111|Behavioral|Cognitive Training|
16150724|NCT01775111|Behavioral|Strength Training|
16150725|NCT01775111|Dietary Supplement|FortiFit|
16150726|NCT01775098|Drug|allopurinol|No arms will not be change as the study as been closed.
16150727|NCT01775085|Behavioral|manualized group intervention|MCG-BCS manual outlines 8 approximately, 90-minute modules: 1) Concepts & Sources of Meaning; 2) Identity, Cancer Survivorship, & Meaning; 3) Historical Sources of Meaning: Past Legacy; 4) Historical Sources of Meaning: Present & Future Legacy; 5) Attitudinal Sources of Meaning: Encountering Life's Limitations; 6) Creative Sources of Meaning: Creativity & Responsibility; 7) Experiential Sources of Meaning: Connecting with Life via Love, Beauty, & Humor; and 8) Transitions: Reflections & Hopes for the Future.
16150728|NCT01775085|Behavioral|standardized, manualized group intervention|DG is a standardized, manualized group developed by the MSKCC Psychiatry Service and utilized in a similar form in our completed and ongoing RCTs of MCGP. Based on models described by Rogers and Bloch, the essential components include reassurance, explanation, education, encouragement, and permission for expression. The process emphasizes Rogerian concepts (e.g., empathic understanding) and avoids techniques that are not exclusively supportive. The content focuses on education about here-and-now topics relevant to BCS (e.g., maintaining and eliciting social support, financial strains, return to work, physical symptom management), allowing emotional expression and discussion of difficult topics.
16150729|NCT01775072|Genetic|molecular profiling of tumors|"Part A is the molecular profiling of tumors. No new tumor biopsies will be performed in the context of Part A. If a pt does have a surgery or tumor biopsy , leftover tissue (or an additional core) from this procedure may be used for molecular profiling. Clinical Assay(s): This testing will be performed in the CLIA-certified Molecular Diagnostics Service laboratory. Research Assay(s): This protocol will also be used as a platform to pilot the use of investigational next-generation profiling technologies .including whole exome sequencing, whole genome sequencing RNA sequencing cell-free tumor DNA/RNA sequencing, proteomics, & others. To confirm the findings obtained on these assays using an orthogonal assay, additional sequencing such as Sanger,Sequenom, MiSeq or IMPACT testing may be utilized in either the CLIA or non-CLIA setting Part B: DTC Cohort Pts successfully registered to Part B of this study will be eligible for minimal risk collection & research biopsies."
16150769|NCT01774760|Procedure|Pretreatment PET/CT-scan (performed two times)|
16150770|NCT01774747|Drug|DSP-1053|DSP-1053 10, 15, 20, 30, 45, 60, 90 mg once daily for 14 days
16151137|NCT01771588|Dietary Supplement|Human milk fortifier|
16150730|NCT01775072|Genetic|Clinical Germline Analysis|"Part C: Clinical Germline Analysis Participants who have donated a matched normal peripheral blood sample for comparison to somatic sequence will be offered the opportunity to have that germline DNA sample analyzed for the presence of deleterious or likely deleterious mutations in genes on the MSK-IMPACT panel that are known to be linked to inherited susceptibility or that are included on consensus lists of genes that should undergo secondary analysis (e.g. the ACMG list)."
16150731|NCT01775059|Device|Integrated sensor and infusion set.|
16150732|NCT01775046|Device|DTA patients (Valiant)|Valiant Thoracic Stent Graft Implantation
16150733|NCT01775033|Other|Multicomponent intervention|Develop, implement and evaluate an organized system of regional pediatric emergency care in rural Western Pennsylvania using four pillars: education, community, protocolized triage and transport, and telemedicine.
16150734|NCT01775020|Dietary Supplement|L-arginine|
16150735|NCT01775007|Device|Brillouin Ocular Analyser|Measurement of the local viscoelastic properties (Brillouin Shift) of the Anterior Eye Segment.
16150736|NCT01774994|Other|stable isotope infusion for measurement of metabolism|
16150737|NCT01774981|Drug|Placebo|Administered IV
16150738|NCT01774981|Drug|LY3016859|Administered IV
16150739|NCT01774968|Drug|Human Regular U-500 Insulin|
16150740|NCT01774942|Procedure|Procedure/Surgery|All teeth were extracted and replaced by a set of provisional full dentures in upper and lower jaws. Three months after extractions, dental implants were surgically placed and mucosa sutured over them. Three monts later, the dentures were re-lined and fitted onto the implants. Blood draw done by phlebotomist.
16150741|NCT01774929|Drug|TTS-fentanyl|TTS-fentanyl patches releasing at the rate of 12.5 microgram per hour for 3 days. The patches will be replaced every 3 days until 30 days.
16150742|NCT01774916|Genetic|blood samples|
16150743|NCT01774903|Drug|TTS-fentanyl|TTS-fentanyl patches releasing drug at the rate of 12.5 microgram (µg) per hour for 3 days. The patches will be replaced every 3 days until 30 days.
16150744|NCT01774877|Drug|Xinfeng capsule|Xinfeng capsule:Three each time, 3 times a day, Oral,for 3 months; placebo(for leflunomide):10mg each time, 1 time a day, Oral,for 3 months; Participants will continue on the stable dose of glucocorticoids and NSAIDs that they were receiving prior to study entry
16150745|NCT01774877|Drug|leflunomide|leflunomide :10mg each time, one time a day, Oral,for 3 months; placebo(for xinfeng capsule):Three each time, 3 times a day, Oral,for 3 months; Participants will continue on the stable dose of glucocorticoids and NSAIDs that they were receiving prior to study entry
16150746|NCT01774864|Drug|DA-8159 (Udenafil)|
16150747|NCT01774864|Drug|Placebo|
16150748|NCT01774851|Drug|MM-111|MM-111 (IV)
16150749|NCT01774851|Drug|Paclitaxel|Paclitaxel (IV)
16150750|NCT01774851|Drug|Trastuzumab|Trastuzumab (IV)
16150751|NCT01774838|Drug|Prasugrel|3 months treatment
16150752|NCT01774838|Drug|Clopidogrel|3 months treatment
16150753|NCT01774825|Dietary Supplement|IQP-CL-101|2 softgels twice a day
16150754|NCT01774825|Other|Placebo|2 softgels twice a day
16150755|NCT01774812|Dietary Supplement|Alfacalcidol|0.25 mcg 3x per week for 6 weeks
16150756|NCT01774812|Dietary Supplement|Ergocalciferol|50,000IU 1x per week for 6 weeks
16150757|NCT01774799|Behavioral|Advance care planning intervention|
16150758|NCT01774799|Other|Control group|
16150759|NCT01774786|Drug|5-Fluorouracil|Participants will receive 5-fluorouracil 800 milligrams per meter square (mg/m^2)/24 hour IV infusion for 120 hours (Days 1-5) q3w for 6 cycles.
16150760|NCT01774786|Drug|Capecitabine|Participants will receive capecitabine 1000 mg/m^2 orally twice daily, evening of Day 1 to morning of Day 15 (28 doses) q3w for 6 cycles.
16150761|NCT01774786|Drug|Cisplatin|Participants will receive cisplatin 80 mg/m^2 IV q3w for 6 cycles.
16150762|NCT01774786|Drug|Pertuzumab|Participants will receive pertuzumab 840 mg IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
16150763|NCT01774786|Drug|Placebo|Participants will receive placebo (matched to pertuzumab) IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
16150764|NCT01774786|Drug|Trastuzumab|Participants will receive 8 mg/kg IV initial dose on Day 1, followed by 6 mg/kg IV q3w until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
16150765|NCT01774773|Drug|Group A: E5501 5mg, then 20mg, then 40 mg, then 5mg|"The post-randomization phase consists of the Treatment Period 1 (Visits 2-8): participants received one 5 mg tablet under fed conditions on treatment morning for 28 days. Treatment Period II (visits 9-15): 20 mg (four 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period III (visits 16-22): 40 mg (eight 5 mg tablets) under fed conditions on treatment morning for 28 days.
~Treatment Period IV (visits 23-29): 5 mg tablet on treatment morning under fasted conditions for 28 days.
~The washout period of 27 days or longer was set between the administration of the study drug in Treatment Periods 1, 2 and 3 and that in Treatment Periods 2, 3 and 4 respectively."
16150766|NCT01774773|Drug|Group B: E5501 20mg, then 40mg, then 5 mg, then 5mg|"The post-randomization phase consists of the Treatment Period 1 (Visits 2-8): participants received 20 mg (four 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period II (visits 9-15): 40 mg (eight 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period III (visits 16-22): one 5 mg tablet under fed conditions on treatment morning for 28 days.
~Treatment Period IV (visits 23-29): 5 mg tablet on treatment morning under fasted conditions for 28 days.
~The washout period of 27 days or longer was set between the administration of the study drug in Treatment Periods 1, 2 and 3 and that in Treatment Periods 2, 3 and 4 respectively."
16150767|NCT01774773|Drug|Group C: E5501 40mg, then 5mg, then 20 mg, then 5mg|"The post-randomization phase consists of the Treatment Period 1 (Visits 2-8): participants received 40 mg (eight 5 mg tablets) under fed conditions on treatment morning for 28 days. Treatment Period II (visits 9-15): one 5 mg tablet under fed conditions on treatment morning for 28 days. Treatment Period III (visits 16-22): 20 mg (four 5 mg tablets) under fed conditions on treatment morning for 28 days.
~Treatment Period IV (visits 23-29): 5 mg tablet on treatment morning under fasted conditions for 28 days.
~The washout period of 27 days or longer was set between the administration of the study drug in Treatment Periods 1, 2 and 3 and that in Treatment Periods 2, 3 and 4 respectively."
16150768|NCT01774760|Drug|18F-EF5|
16150771|NCT01774747|Drug|Placebo|Placebo 10, 15, 20, 30, 45, 60, 90 mg once daily for 14 days
16150772|NCT01774734|Other|Physical therapy|"Physical therapy
~Provided by 2 experienced physiotherapist
~Applied to every patients 3 times weekly"
16150773|NCT01774734|Device|Neck Strength Exerciser (NSE)|"Neck strength exerciser use 10-20 minutes daily at home
~Plus traditional physical therapy three times weekly provided by two experienced physical therapist"
16150774|NCT01774721|Drug|Dacomitinib (PF-00299804)|Dacomitinib (PF-00299804) 45 mg tablets, continuous oral daily dosing.
16150775|NCT01774721|Drug|Gefitinib|Gefitinib 250 mg tablets, continuous oral daily dosing.
16150776|NCT01774708|Device|Pressure sensitive pad|"The proposed research uses an investigational device from EarlySense consisting of a pressure sensitive piezoelectric pad 350 mm x 226 mm x 12 mm or a little less than 9 by 13 inches and under a half inch thick connected to a cord resembling a phone cord to a controller 10.3 by 10.5 by 5.5 inches which in turn plugs into a standard electrical outlet. The power cord is modu¬lar, so it is possible to select a cord that is long enough without having excessive extra length. The con¬nec¬tion between the pad and the monitor has a quick release like a modular telephone.
~This system is designed to very unobtrusively collect heartbeat patterns, respiratory patterns, motion in bed, and bed-exit data with no risk or inconvenience to the patient."
16150777|NCT01774695|Behavioral|Increased physical activity|"The subjects were encouraged to increase their level of physical activity for 12 weeks in the previous study.
~The advice was individual but was based on the recommendations of the Swedish National Institute of health. The recommendation for increasing cardiorespiratory fitness is 20-60 minutes of moderate to vigorous intensive physical activity 3 to 5 days per week."
16150778|NCT01774682|Procedure|6-minute walk test|the test corresponds to that defined by Abdel Kafi et al in 2005
16150779|NCT01774669|Device|YouGrabber training device from YouRehab Ltd.|Patients in the experimental group (EG) will receive 16 training sessions lasting for 45 minutes each. The treatment focus is the upper extremity, in particular finder and hand function, movement coordination, and speed.
16150780|NCT01774669|Other|Therapy (PT, OT)|Patients in the control group (CG) will receive 16 therapy sessions physiotherapy or occupational therapy) lasting for 45 minutes each. The therapy focuses on upper limb movements, in particular finger and hand movements. Furthermore, movement coordination and speed shall be trained.
16150781|NCT01774656|Drug|Pharmacological Treatment|The pharmacological treatment intended to enhance reverse remodeling includes 4 drugs initiated immediately after weaning of inotropic support once achieving adequate end-organ recovery and titrated (against symptoms, potassium, and renal function) to the following maximum doses: lisinopril 40 mg daily; carvedilol 25 mg 3 times daily; spironolactone 25 mg daily; digoxin 125g daily, and losartan 150 mg daily.
16150782|NCT01774630|Drug|Nilotinib|300 mg/twice a day
16150783|NCT01774604|Drug|Indomethacin|100 mg Indomethacin PR x 1
16150784|NCT01774604|Drug|Placebo|
16150785|NCT01774591|Drug|Azilsartan medoximil|All subjects were randomized to 80mg azilsartan medoxomil (azilsartan) daily or placebo and followed for six months.
16150786|NCT01774591|Drug|Placebo|All subjects were randomized to 80mg azilsartan medoxomil (azilsartan) daily or placebo and followed for six months.
16150787|NCT01774578|Drug|Docetaxel|Docetaxel given in Arm 1 prior to first progression on study. Given as an option of salvage therapy after first progression on study for Arms 2a and 2b.
16150788|NCT01774578|Biological|HyperAcute®-Lung Immunotherapy|"HAL-1, HAL-2 and HAL-3 immunotherapy components.
~Up to 16 immunizations of 300 million immunotherapy cells."
16150789|NCT01774578|Drug|Gemcitabine|Given as an option of salvage therapy after first progression on study for Arms 1, 2a and 2b.
16150790|NCT01774578|Drug|Pemetrexed|Given as an option of salvage therapy after first progression on study for Arms 1, 2a and 2b.
16150791|NCT01774565|Device|Fully Automated Closed-Loop Insulin Delivery|
16150792|NCT01774565|Device|Conventional insulin therapy|
16150793|NCT01774552|Device|Photo Acoustic Microscopy and Optical Coherence tomography|Photo Acoustic Microscopy and Optical Coherence tomography
16150794|NCT01774539|Other|Diffusion MRI|Each subject will undergo one diffusion MRI scan to identify characteristics of their physes
16150795|NCT01774526|Other|Characterise the molecular epidemiology of lung adenocarcinoma in multi-ethnic asian phenotypes|
16150796|NCT01774513|Device|Procore-Needle|
16150797|NCT01774487|Drug|Pentoxifylline|20 mg/kg/day divided in 3 doses, given orally for 90 days
16150798|NCT01774474|Drug|Bromfenac|
16150799|NCT01774474|Drug|Dexamethasone|
16150800|NCT01774474|Drug|Bevacizumab|
16150801|NCT01774474|Drug|Triamcinolone Acetonide|
16150802|NCT01774461|Other|Remote ischemic preconditioning|Blood pressure cuff placed on upper arm and inflated to 200mmHg for 5 minutes then deflated for 5 minutes - this cycle is repeated a total of 4 times.
16150803|NCT01774448|Behavioral|Mindfulness-Based Cognitive Therapy|In the experimental condition, individuals with dementia (n = 15) and their spouses (n = 15) will partake in one MBCT session per week for 8 weeks. The partners will attend separate MBCT sessions (different day of the week). In the control condition, individuals with dementia (n = 15) and their spouses (n= 15) will go through an 8-week waitlist control period.
16150804|NCT01774435|Drug|EN3342|
16150805|NCT01774422|Device|Extracorporeal CO2 removal device|
16150806|NCT01774409|Genetic|Blood and tumor samples|"Genetic: Establishment of the genetic and immunologic profile
~Whole blood sampling :
~1 tube for the constitutional DNA extraction;
~3 tubes for ancillary studies and research.
~Collection of the available archival tumor sample (frozen or FFPE). If there's no available sample, the investigator will prescribe a biopsy of a reachable lesion.
~With the established profile, recommendations will be given by a multidisciplinary molecular board."
16150807|NCT01774396|Drug|Emervel® Touch|Emervel® Touch will be injected only in the intervention group.
16150808|NCT01774396|Drug|Emervel® Volume Lidocaine and Emervel® Deep Lidocaine|Emervel® Volume Lidocaine and Emervel® Deep Lidocaine will be injected in the group #2.
16150809|NCT01774370|Drug|Pradaxa (Dabigatran etexilate mesilate)|110 mg or 150 mg b.i.d.
16150810|NCT01774344|Drug|Regorafenib (Stivarga, BAY73-4506)|Regorafenib, 40 mg tablets
16150811|NCT01774344|Drug|Placebo|Placebo tablets matching in appearance
16150812|NCT01774318|Other|aEEG and conventional EEG measurement|aEEG and conventional EEG measurement including video-polysomnography
16150813|NCT01774305|Drug|Dexmedetomidine|We administrate the dexmedetomidine single bolus (0.5ug/kg, intravenously) at time of muscle layer closing.
16150814|NCT01774305|Drug|Saline|We administrate the normal saline (single bolus, 0.25ml/kg) intravenously at time of muscle layer closing.
16150815|NCT01774292|Procedure|Endotracheal intubation with injection of liquid in the cuff|
16150816|NCT01774279|Other|Tissue, blood and clinical data collection|
16150817|NCT01774253|Drug|Vismodegib|
16150818|NCT01774240|Other|systematic screening and treatment of delirium|systematic screening for delirium with DOS scale and CAM ICU. In case of delirium, treatment according to guidelines.
16150819|NCT01774227|Procedure|The pops-titration group|The energy delivery is started at a low level and is increased in intervals till an audible pop is heard, following which the power is reduced downward until the pops are no longer audible, then the treatment is completed at these parameters
16150820|NCT01774227|Procedure|The slow-coagulation group|The Gaasterland's slow-coagulation energy delivery technique using the lower power for the longer duration.
16150821|NCT01774214|Procedure|Push-Pull technique|"Participants will administer 900 mL (60 mL/kg) of NS to a model of a 15 kg toddler in shock. The intervention is the mode of administration of the fluid. For the Push-Pull Technique, the 7 cm catheter extension tubing will be connected to one of the three ports of a triple stopcock. A second of the 3 ports of the triple stopcock will be connected to an IV tubing set connected to a 1 L bag of NS. A 60 mL syringe will be connected to the third port of the triple stopcock. On verbal prompt, participants will pull fluid from the bag of NS by withdrawing the plunger of the 60 mL syringe, filling it with saline. They will then toggle the switch of the triple stopcock, so that it is off to the bag of NS and open to IV catheter extension tubing leading to the model. They will then depress the syringe plunger, administering the fluid to the model. These steps will be repeated until each participant believes that they have administered the requested volume of fluid to the model."
16150822|NCT01774214|Procedure|Disconnect-Reconnect Technique|"Participants will administer 900 mL (60 mL/kg) of NS to a model of a 15 kg toddler in shock. The intervention is the mode of administration of the fluid. For the Disconnect-Reconnect Technique, the proximal end of the 7 cm catheter extension tubing will be capped with a needleless adapter. The subject will be provided with 60 mL syringes filled with NS, rapidly prepared in real time by an assistant. Syringes will be prepared by withdrawing NS from a 1 L bag via a Gambro Accessory spike. The subject will administer the requested volume of NS to the model by 1. grabbing one of the fluid-filled syringes 2. connecting the fluid-filled syringe to the needleless adapter, and 3. depressing the syringe plunger resulting in administration of the NS to the model. These steps will be repeated until the subject believes they have administered the requested volume of NS to the model. Testing will begin on verbal prompt. The subject and assistant will not be permitted to switch roles."
16150823|NCT01774201|Other|Breathing exercises|Breathing exercises with positive expiratory pressure.
16150824|NCT01774162|Device|Fine needle biopsy using ProCore needle for histology.|EUS-guided biopsy of each solid lesion using the EchoTip® ProCore™ ultrasound FNB needle for histology.
16150825|NCT01774162|Device|Fine needle aspiration using conventional FNA for cytology|EUS-guided biopsy of each solid lesion using the EchoTip® Ultra™ FNA needle for cytology.
16150826|NCT01774149|Device|Few Touch Application|Users get access to the regular version of the Few Touch Application for Type 1 Diabetes.
16150827|NCT01774149|Device|Diastat|Users get the Few Touch Application with Diastat module activated.
16150828|NCT01774136|Behavioral|Enhanced HIV and MCH training for CHW|
16150829|NCT01774110|Other|Early standardized task training|Early standardized task training is a treatment approach using treadmill training applied very early after stroke onset.
16150830|NCT01774097|Biological|ALD-301|Ten 1ml injections of ALD-301 in the index calf and posterior, lower thigh
16150831|NCT01774097|Biological|Placebo (vehicle)|Ten 1ml injections of placebo in the index calf and posterior, lower thigh
16150832|NCT01774084|Dietary Supplement|Experimental: PreOp, NutriciaNordica AB|
16150833|NCT01774084|Dietary Supplement|Placebo Comparator: Water|
16150834|NCT01774071|Drug|89Zr- DFO-MSTP2109A|"If you are enrolled onto Group 1:
~Once you are given the diagnostic agent, the following procedures will be done:
~PET scans at the approximate times:
~1-4 hours after the injection
~24 hours after the injection (the next day, Day 2)
~48-120 hours after the injection (on either Day 3, 4, or 5)
~144-168 hours after the injection (on either Day 6, 7, or 8) You will also have research bloods drawn on the following times and days,
~Day 1: before the injection, approximately 5 minutes after, 30 minutes after, 1 hour after and 2-4 hours after the injection.
~At each time of your scheduled PET scan."
16150835|NCT01774071|Drug|89Zr DFO-MSTP2109A|"If you are enrolled onto Group 2:
~Once you are given the study drug, the following procedures will be done:
~You will have one PET scan done. The timing of the PET scan will be determined at the time of your enrollment (~ 3-7 days after injection).
~No research blood work will be drawn in Group 2"
16150836|NCT01774058|Drug|Ilomedin|3000ng ilomedin in 15ml salt water will be injected intraarterial into the common femoral artery over 2 minutes for one time,then the investigators will measure the blood flow volume after 5 and then after 10 minutes on the common femoral artery. The patients will be observed by the anaesthesiologist. The patient will get ilomedin one day before the surgery and then for 6 day after surgery into the vein. (10microgramm/o,5ml in 250ml salt water)
16150837|NCT01774045|Drug|PDC-1421|
16150838|NCT01774045|Drug|Placebo|
16150839|NCT01774032|Biological|H5N1 Influenza Vaccine (Whole Virion, Vero Cell-Derived, Inactivated), non-adjuvanted formulation|
16150840|NCT01774019|Device|WallFlex™ Biliary RX Fully Covered/Uncovered Stent System|
16150841|NCT01774006|Other|individual embryo culture or group culture|Embryos cultured in a 25 microliter droplet of culture media individually in a conventional petridish or in groups of 2-10 embryos in a Well-of-the-Well petridish
16150842|NCT01773993|Drug|Pregabalin|The usual adult dosage for oral use begins at 150 mg/day of pregabalin twice daily, and should be gradually increased to 300 mg/day over 1 week or more and then maintained at 300-450 mg/day as needed. Dosage should be adjusted, depending on age or symptoms. However, the daily maximum dose should not be beyond 450 mg, and should be orally administered twice daily.
16150843|NCT01773980|Other|Clinic Intervention|The Clinic intervention consists of an educational video, an interactive meeting with clinicians and clinic staff, and a facilitated follow-up meeting with clinic staff.
16150844|NCT01773980|Other|Patient Intervention|The patient intervention consists of a single 90-minute interactive in-person session.
16150845|NCT01773967|Drug|LGG|LGG 10^10 cfu PO BID X 5 days
16150846|NCT01773967|Drug|micro-crystalline cellulose|1 capsule PO bid x 5 days
16150847|NCT01773954|Drug|Intravitreal Aflibercept Injection|Increased or decreased time between visits
16150848|NCT01773928|Biological|Vero cell-derived trivalent influenza vaccine manufactured with the modified manufacturing process (VCIV modified)|
16150849|NCT01773928|Biological|VCIV manufactured with the current manufacturing process (VCIV current)|
16150850|NCT01773928|Biological|Fluzone®, licensed trivalent influenza vaccine (TIV)|
16150851|NCT01773902|Dietary Supplement|High Dose Protein (Individualized)|Protein supplementation according to breast milk content aiming for 4.5g/kg/d of enteral protein if <1500g b.w. or 4.0g/kg/d of enteral protein if >1500g b.w. until 1 week before discharge
16150852|NCT01773902|Dietary Supplement|High Dose Protein (Standardized)|Protein supplementation independent of individual breast milk content using a new high-dose-protein breast milk fortifier until 1 week before discharge
16150853|NCT01773902|Dietary Supplement|Standard Protein Supplementation|Protein supplementation independent of individual breast milk content using a standard-dose-protein breast milk fortifier until 1 week before discharge
16150854|NCT01773889|Drug|Denileukin Diftitox/SC Pegylated IFNα-2a|
16150855|NCT01773876|Drug|Micafungin|"MYCAMINE 100 mg intravenous 100 mg of powder reconstituted in a 100 ml infusion bag of sodium chloride 0.9%
~infusion over 24 hours for 14 days discontinuation of treatment if proven invasive candidiasis"
16150856|NCT01773876|Drug|PLACEBO|solution of sodium chloride 0.9% 100 ml for intravenous infusion infusion over 24 hours for 14 days discontinuation of placebo if proven invasive candidiasis
16150857|NCT01773850|Device|Stationary Carbon Nanotube X-ray Digital Breast Tomosynthesis Scanner|All patients will undergo conventional imaging and imaging with the carbon nanotube based x-ray stationary digital breast tomosynthesis scanner device.
16150858|NCT01773837|Drug|methylphenidate|methylphenidate (pill) p.o. 15 to 25 mg daily for six days
16150859|NCT01773837|Drug|placebo|placebo (pill) p.o.
16150860|NCT01773824|Behavioral|Antibiotic prescription feedback|Monthly postal and electronic feedback on antibiotic prescription rates
16150861|NCT01773824|Behavioral|No Feedback|Physicians in the control group will only be monitored for their antibiotic prescription rates (Physicians are unaware of the trial)
16150862|NCT01773811|Behavioral|Narrative Writing: Trauma-Assigned|Individuals will be writing about their most traumatic life event for 3 consecutive days for 20 minutes each. Those in the assigned group will be given instructions and weekly reminders to continue to think about their most traumatic event.
16150863|NCT01773811|Behavioral|Narrative Writing: Trauma-Spontaneous|Individuals will be writing about their most traumatic life event for 3 consecutive days for 20 minutes each. Those in the spontaneous group will be given no further instructions.
16150864|NCT01773798|Drug|insulin degludec/insulin aspart 15|Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.5 U/kg Body Weight (BW).
16150865|NCT01773798|Drug|insulin degludec/insulin aspart|Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.5 U/kg Body Weight (BW).
16150866|NCT01773798|Drug|insulin degludec|Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.425 U/kg Body Weight (BW).
16150867|NCT01773798|Drug|insulin aspart|Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days. The dose level will be 0.075 U/kg Body Weight (BW).
16150868|NCT01773798|Drug|placebo|Each subject subject will be randomly allocated to five single doses. Administered subcutaneously (s.c, under the skin) on five dosing visits separated by 15-25 days.
16150869|NCT01773785|Drug|SPI-1620|SPI-1620 11 μg/m2 will be given intravenously over 1 minute.
16150870|NCT01773785|Drug|Docetaxel|Docetaxel 75 mg/m2 infusion will be administered per standard of care 10 (±2) minutes after SPI-1620.
16150871|NCT01773772|Drug|Progesterone|Subjects will take 25-50 mg oral micronized progesterone at 1600 h and again at 2000 h. Progesterone dosing will be based on weight, with 25 mg administered to girls < 42kg and 50 mg given to those or = to 42 kg.
16150872|NCT01773772|Drug|Placebo|Subjects will take oral placebo suspension at 1600 h and again at 2000 h.
16150873|NCT01773759|Behavioral|Intervention child care programs|Interventions will be designed based on findings from Aims 1 and 2, will include outreach and education, and may include on-site demonstration and USIIS training or peer tutoring.
16150874|NCT01773746|Other|Neonatal Resuscitation|CPAP or Positive Pressure Ventilation will be provided.
16150875|NCT01773707|Drug|CTLA4-Ig (Abatacept)|Given as 30 minute IV infusion
16150876|NCT01773707|Drug|Placebo|Saline given as 30 minute IV infusion
16150877|NCT01773694|Behavioral|Early Water Exposure|"The Early Water Exposure (Intervention) group will receive written and verbal instructions to remove the dressing after 6 hours and wet the wound for at least 10 minutes. Wetting of the wound will include shower, tub bath, or pool exposure.
~On subsequent days, all participants, regardless of group assignment, will wash the wound daily with soap and water, reapply white petrolatum and a dry dressing."
16150878|NCT01773681|Drug|Cimzia|"For the loading phase, it consists of the first 3 doses. During the loading phase, the recommended dose of Cimzia for adults with rheumatoid arthritis is 400mg initially followed by 400mg again at week 2 and week 4. A 400mg dose requires 2 subcutaneous injection of 200mg; the injections should occur at separate sites in the thigh or abdomen.
~After the loading dose, will be follow with 200mg every other week. The injection should occur at either the thigh or abdomen."
16150879|NCT01773681|Device|Magnetic Resonance Imaging (MRI)|MRI of the dominant wrist, before, during and after the gadolinium contrast injection will be acquired. The dose of the gadolinium agent for this study is 0.1mmol/kg body weight. This gadolinium contrast agent will increase the image contrast in the joints in the wrist and surrounding tissues and will make the MRI pictures stand out better.
16150950|NCT01773148|Device|Arstasis Access System (AXERA)|Placement of the AXERA device in the Femoral Artery.
16150880|NCT01773681|Device|High-resolution peripheral quantitative computed tomography (HR-pQCT)|HR-pQCT scan of the hand and wrist will be acquired to look at the bone quality. The scan uses special x-ray equipment to make detailed pictures of bone structure.
16150881|NCT01773668|Device|Integrated sensor and infusion set.|
16150882|NCT01773655|Other|tumor specimens|"All consenting patients (Consent 1) will participate in an anonymized assessment of the prevalence of germline BAP1 mutations. Available tumor specimens from patients with MPM and metastatic uveal melanoma will be tested for BAP1 mutation. Patients whose tumors harbor BAP1 mutations and/or meet the criteria for germline mutation specified in 2.2.2 will be approached for identified germline BAP1 testing after appropriate pre-test counseling (Consent 2).
~Patients who, through identified testing, are found to have germline BAP1 mutations will be asked to invite their relatives to participate in germline testing (Consent 3). First-degree relatives and any relatives with a malignancy will be prioritized. Expanding testing to family members of patients with BAP1 germline mutations is essential to delineate the penetrance and describe the various manifestations of this new cancer predisposition syndrome."
16150883|NCT01773642|Behavioral|Cognitive behavioral intervention to support pediatric HIV disclosure|
16150884|NCT01773629|Other|Intervention|Participants in the intervention arm will receive standard care plus the addition of a care manager. Care managers will function to provide culturally competent and linguistically appropriate support for the care of women identified as being at high risk for depression in pregnancy. Working with both the care providers and these study participants care managers will serve as connectors, coaches, collaborators, and negotiators working to overcome barriers to depression care delivery.
16150885|NCT01773629|Other|Control|"Standard of care: within the current care processes, a woman initiating prenatal care completes a depression risk assessment using a two-step approach. Women with high risk of depression are then scheduled for a separate visit with a member of the care team (a physician, psychologist, or other mental health provider) referred to as a perinatal depression champion for a timely formal diagnostic interview."
16150886|NCT01773616|Drug|Oral prednisolone|
16150887|NCT01773616|Drug|Rituximab|
16150888|NCT01773616|Drug|Mycophenolate mofetil|
16150889|NCT01773616|Drug|Methyl prednisolone|
16150890|NCT01773603|Device|Embryoscope|Five-day embryo culture in embryoscope which is an incubator with a built-in camera
16150891|NCT01773590|Other|Rhinovirus Infection|
16150892|NCT01773564|Device|Current hospital dressing|Patients were assigned to either arm following a randomization scheme 1:1.
16150893|NCT01773564|Device|3M™ IV Advanced Securement dressing|Patients were assigned to either arm following a randomization scheme 1:1.
16150894|NCT01773551|Other|Breast Density|Development of a Quantitative Tissue Optical Index of Breast Density
16150895|NCT01773538|Drug|Lactulose and rifaximin|3 months treatment. lactulose 25 Ml x3 per day. Rifaximin (550 mg) x 2 per day.
16150896|NCT01773538|Dietary Supplement|Branched Chain amino acids|30 grams of branched chain amino acids (Bramino) per day is given to the patients in the antiHE treatment arm along with lactulose and rifaximin.
16150897|NCT01773538|Other|Placebo|Patients in the placebo-arm receives both placebo-Bramino, placebo-lactulose and placebo-rifaximin.
16150898|NCT01773512|Drug|Rosuvastatin|All patients will be using rosuvastatin 40 mg
16150899|NCT01773486|Drug|Hesperidin|Citrus polyphenol, hesperidin
16150900|NCT01773486|Drug|Placebo|Placebo matching hesperidin
16150901|NCT01773473|Drug|Insulin Lispro Mix25|Administered SC
16150902|NCT01773473|Drug|Insulin Lispro Mix50|Administered SC
16150903|NCT01773460|Drug|Everolimus|Everolimus is given beyond progress (comparison with placebo)
16150904|NCT01773460|Drug|Everolimus-placebo|Everolimus-placebo
16150905|NCT01773447|Procedure|Set-back suture|
16150906|NCT01773447|Procedure|Vertical mattress suture|
16150907|NCT01773434|Drug|MORAb-004|"MORAb-004 5 mg/mL is administered as an intravenous infusion (IV) in an escalating dose design and will not be escalated or de-escalated in individual participants.
~Part 1 (Dose escalation): 4 weekly administrations of 2, 4, 8, and 12 mg/kg in four different cohorts on Days 1, 8, 15, and 22 of a 4-week cycle (28 days).
~Part 2 (Cohort expansion): 4 and 8 mg/kg on Days 1, 8, 15, and 22 of a 4-week cycle (28 days) and 12 mg/kg biweekly administration on Days 1 and 15 of a 4-week cycle in different cohorts. The dosages in Part 2 can be amended considering the results of Part 1."
16150908|NCT01773421|Drug|E7820|"FOOD EFFECT STUDY:
~Each subject (a minimum of 12 subjects) will be assigned according to a randomization code to receive a single 50 mg dose of E7820 on Day 1, either after fasting for 10 hours, or immediately after consuming a high fat breakfast. Following a 7-day washout period, the subjects will crossover and a second 50 mg dose of E7820 will be administered on Day 8."
16150909|NCT01773421|Drug|E7820|"MTD DETERMINATION FOR BID DOSING SCHEDULE
~The initial dose of E7820 will be 50 mg BID. If allowed by the rules for dose escalation, the dose escalations will be to 60 mg BID, 80 mg BID, and 100 mg BID."
16150910|NCT01773408|Drug|RO5503781 MBP|Participants will receive RO5503781 tablets daily (current formulation) containing microprecipitated bulk powder (MBP) at a starting dose of 400 milligrams (mg).
16150911|NCT01773408|Drug|RO5503781 SDP|Participants will receive RO5503781 tablets daily (new optimized formulation) containing spray-dried powder (SDP) at recommended dose(s) for development from Phase 1b to Phase 3.
16150912|NCT01773408|Drug|Idarubicin|Idarubicin will be administered as per standard clinical practice.
16150913|NCT01773408|Drug|Daunorubicin|Daunorubicin will be administered as per standard clinical practice.
16150914|NCT01773408|Drug|Cytarabine|Parts 2 and 4: Participants will receive cytarabine 1000 milligrams per meter squared (mg/m^2) intravenous (IV) infusion daily. Part 3: Participants will receive cytarabine 100-200 mg/m^2 IV infusion daily.
16150915|NCT01773395|Biological|GVAX|GVAX or placebo vaccination will begin between 30 to 60 days following participant's transplant, provided participant meets vaccination initiation criteria. Only participants in the GVAX arm will receive GVAX vaccine.
16150916|NCT01773395|Biological|Placebo Vaccine|GVAX or placebo vaccination will begin between 30 to 60 days following participant's transplant, provided participant meets vaccination initiation criteria. Only participants in the placebo arm will receive placebo vaccine.
16150949|NCT01773161|Procedure|Cerebral palsy, post hip surgery|All subjects will undergo surgical treatment for hip subluxation or dislocation. HRQoL, radiographic, and clinical data will be measured at multiple time points.
16150917|NCT01773395|Procedure|Allogeneic Hematopoietic Stem Cell Transplant|Between 1-2 days after participant finishes the chemotherapy, the participant will receive the blood stem cell or marrow from their donor. This is given as a transfusion through a central intravenous line (IV usually placed in the chest or arm).
16150918|NCT01773395|Drug|Busulfan|In this study the condition regimen will include 2 chemotherapy drugs: busulfan (twice a day or four times a day for 5 days) and fludarabine (once daily for 4 days). Depending on participant's age, and other clinical factors, the transplant doctor will decide whether the participant will receive a higher or lower dose of busulfan.
16150919|NCT01773395|Drug|Fludarabine|In this study the condition regimen will include 2 chemotherapy drugs: busulfan (twice a day or four times a day for 5 days) and fludarabine (once daily for 4 days). Depending on participant's age, and other clinical factors, the transplant doctor will decide whether the participant will receive a higher or lower dose of busulfan.
16150920|NCT01773395|Drug|Tacrolimus|"Just prior to and immediately following the infusion of stem cells, the participant will receive medications to help prevent graft-versus-host disease (GVHD), a common complication of transplant where the donor's immune cells attack the recipient's body. The medications the participant will receive to prevent GVHD will include:
~Tacrolimus- This will be taken orally twice daily start 3 days before the transplant, and will continue for about 6-9 months.
~Methotrexate- This will be given a short intravenous infusion on days 1, 3, 6, and 11 after the transplant."
16150921|NCT01773395|Drug|Methotrexate|"Just prior to and immediately following the infusion of stem cells, the participant will receive medications to help prevent graft-versus-host disease (GVHD), a common complication of transplant where the donor's immune cells attack the recipient's body. The medications the participant will receive to prevent GVHD will include:
~Tacrolimus- This will be taken orally twice daily start 3 days before the transplant, and will continue for about 6-9 months.
~Methotrexate- This will be given a short intravenous infusion on days 1, 3, 6, and 11 after the transplant."
16150922|NCT01773382|Behavioral|weight reduction|"Set target daily energy requirement by nutritionist (25-30 Kcal/Kg/day minus 500 Kcal)
~Advice and encourage patients to do aerobic exercise at least 30 minutes/day for 4-5 days/weeks.
~Daily body weight measurement.
~Record food diary"
16150923|NCT01773369|Behavioral|Early leg training|Children will engage in ~1 hour/day, 4 days/week treatment for 3 months. The treadmill will consist of supported walking on a treadmill, over ground, stair climbing, standing, kicking, splashing ... etc. leg activity. Activities will be directed by a physical therapist in the clinical setting.
16150924|NCT01773369|Behavioral|Delayed leg training|The training activity will be exactly the same as the Early leg training group, except that it will occur ~3 months after recruitment.
16150925|NCT01773369|Behavioral|Parent leg training|Children will engage in ~1 hour/day, 4 days/week treatment for 3 months. The treadmill will consist of supported walking on a treadmill, over ground, stair climbing, standing, kicking, splashing ... etc. leg activity. Activities will be directed by parents in their home or community environment.
16150926|NCT01773356|Dietary Supplement|Dihydrocapsiate|Kellogg's ready to eat cereal, cereal bars, and crackers will contain dihyrocapsiate or placebo. Daily consumption of dihydrocapsiate is 9mg/d or 0mg/d.
16150927|NCT01773343|Procedure|Laser|Fractionel CO2 laser: 1 versus 3 months intervals
16150928|NCT01773330|Procedure|esophageal manometry|Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed.There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.
16150929|NCT01773330|Dietary Supplement|Gatorade|The patient will be given Gatorade to drink at various times during the study.
16150930|NCT01773330|Other|Supine position|Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.
16150931|NCT01773330|Other|Semi-recumbent position|Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.
16150932|NCT01773330|Procedure|Sitting|Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.
16150933|NCT01773330|Procedure|Standing|Esophageal manometry will be performed by swallowing different amounts of Gatorade depending on the protocol being followed. There will be alternate assignment of positions: supine position, semi-recumbent position,sitting position and standing up position.
16150934|NCT01773317|Other|Perturbation|All subjects complete study protocol. Subjects randomized to the perturbation group will complete the additional perturbation exercises
16150935|NCT01773317|Other|Control|Subjects will complete the study protocol (including nordic hamstrings, standing squats, drop jumps, triple single leg hopping, and tuck jumps)
16150936|NCT01773304|Other|Dietary meal intervention|Test meals with different protein types (dairy versus meat)
16150937|NCT01773291|Other|acupuncture|acupuncture on GV26 and 12 Well points
16150938|NCT01773291|Other|laser acupuncture|laser acupuncture on GV26 and 12 Well points
16150939|NCT01773291|Other|control|sham laser acupuncture
16150940|NCT01773278|Drug|Antioxidants|Patients will be prescribed the drug DEKAS plus at a dose based on age and weight. The effects of the treatment will be monitored by serial ERG, ABR, oxysterol levels and clinical findings.
16150941|NCT01773278|Drug|Cholesterol|Patients with SLOS typically have cholesterol deficiency. They will be treated with cholesterol supplementation to keep cholesterol levels > 100 mg/dl if possible
16150942|NCT01773252|Device|Flow Detection System|
16150943|NCT01773239|Behavioral|TARA computer-based exercises|
16150944|NCT01773226|Device|"Autologous Protein Solution APS(TM)"|A therapy prepared at the point-of-care from a small sample of the patient's own blood containing high concentrations of anti-inflammatory and anabolic proteins
16150945|NCT01773213|Procedure|Ice-water-test|
16150946|NCT01773187|Drug|Pacritinib|
16150947|NCT01773187|Drug|Best Available Therapy|
16150948|NCT01773174|Drug|dabigatran etexilate|age & weight adjusted equivalent of adult dose
16151138|NCT01771575|Other|Placebo device|Placebo device
16150951|NCT01773135|Other|collection of blood sample and tocolysis adminstration|"investigators will abtain a blood sample from all patient to measure the serum level of ACTH.
~all patients with threatened preterm labor will receive a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 60 - 160 mg/day (1-2 tablets 3 times daily) of slowly releasing nifedipine (epilat retard 20 mg tablet) may be given depending on uterine activity. The patients will also receive 6 mg dexamethasone every 12 hours for 4 doses. All women will be followed up till delivery.
~After delivery, investigators devide the pateints into 2 groups (full term delivery & preterm delivery) and investigators compare between these 2 groups by level of hormone."
16150952|NCT01773122|Drug|Dapsone Formulation A|Dapsone Formulation A applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
16150953|NCT01773122|Drug|Dapsone Formulation B|Dapsone Formulation B applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
16150954|NCT01773122|Drug|Dapsone Formulation C|Dapsone Formulation C applied once daily to the face, upper chest, upper back, and shoulders for 28 days.
16150955|NCT01773122|Drug|Dapsone 5% Gel|Dapsone 5% gel (ACZONE®) applied twice daily to the face, upper chest, upper back, and shoulders for 28 days.
16150956|NCT01773109|Drug|Etirinotecan pegol (NKTR-102)|Eligible patients will receive etirinotecan pegol at a dose of 145 mg/m2 iv every 3 weeks. One cycle will be defined as 3 weeks. Treatment will be administered on an outpatient basis.
16150957|NCT01773096|Drug|Methylnaltrexone|Patient will receive methylnaltrexone on postoperative day 3 on a weight based dose and again 24 hours later if required.
16150958|NCT01773096|Drug|Senna, docusate sodium, bisacodyl, magnesium hydroxide, Miralax|Standard institutional bowel protocol will begin on post-operative day 1. Miralax,Docusate sodium or senna will be given on a weight-based dosing. If no bowel movement in 72 hours, bisacodyl or magnesium hydroxide will be added.
16150959|NCT01773083|Drug|unfractionated heparin|nebulized 6 times daily, daily dose 150.000 IU for the maximum duration of 14 days
16150960|NCT01773083|Drug|placebo|Placebo: Sterile saline nebulized 6 times daily for the maximum duration of 14 days
16150961|NCT01773070|Drug|ABT-450/ritonavir|ABT-450 coformulated with ritonavir. Drug is not administered -- this study is follow-up for participants previously receiving the drug.
16150962|NCT01773070|Drug|ABT-333|Drug is not administered -- this study is follow-up for participants previously receiving the drug.
16150963|NCT01773070|Drug|ABT-267|Drug is not administered -- this study is follow-up for participants previously receiving the drug.
16150964|NCT01773057|Other|NHGDoc domain Heart Failure|Healthcare providers receive patient specific alerts in terms of diagnosing and treatment of patients with heart failure
16150965|NCT01773044|Drug|alkalinized lidocaine|recevied 0.05 mL/kg lidocaine with bicarbonate ( % 2 lidocaine 5 mL + 1 mL %8,4 NaHCO3+ 4 mL SF)
16150966|NCT01773044|Drug|Lidocaine|0.05 mL/kg lidocaine (% 2 lidocaine 5 mL + 5 mL SF),
16150967|NCT01773044|Drug|Placebo (for alcalinized lidocaine)|
16150968|NCT01773018|Drug|Volitinib|Volitinib(HMPL-504) is a tablet in the form of 25 mg ,100mgand 200 mg,oral,once daily.
16150969|NCT01773005|Drug|Ofirmev|Subject receives the interventional drug, intravenous ibuprofen (800 mg Caldolor) at the induction of anesthesia and intravenous Acetaminophen (1000 mg Ofirmev) at the time of surgical wound closure, followed by 800 mg Caldolor plus 1000 mg Ofirmev every 6 hours until discharge for a total of up to 120 hours (5 days)
16150970|NCT01773005|Drug|Caldolor|Subject receives the interventional drug, intravenous ibuprofen (800 mg Caldolor) at the induction of anesthesia, followed by 800 mg Caldolor every 6 hours until discharge or for a total of up to 120 hours (5 days)
16150971|NCT01772992|Behavioral|CVCTPLUS|For the intervention, couples will receive HIV testing and counseling together as a dyad, and some couples will receive ARV adherence counseling (Partner-STEPS) together as a dyad.
16150972|NCT01772979|Drug|Trabectedin|
16150973|NCT01772966|Procedure|Spinal manipulation|
16150974|NCT01772953|Drug|Treosulfan|This is a phase II, open-label, nonrandomized, prospective study of a preparative regimen consisting of treosulfan, fludarabine and low-dose total body irradiation (TBI) for children with acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) undergoing allogeneic hematopoietic cell transplantation (HCT).
16150975|NCT01772940|Drug|nevirapine|Nevirapine 200 mg twice daily or 400 mg once daily per os during 96 weeks
16150976|NCT01772940|Drug|ritonavir-boosted Lopinavir|ritonavir-boosted lopinavir 800/200 mg once daily or 400/100 mg twice daily per os during 96 weeks
16150977|NCT01772940|Drug|Tenofovir/emtricitabine|tenofovir 300 mg/emtricitabine 200 mg fixed-dose combination once daily, per os for 96 weeks
16150978|NCT01772940|Drug|Zidovudine/lamivudine|zidovudine 300 mg/lamivudine 150 mg twice daily fixed-dose generic combination, per os for 96 weeks
16150979|NCT01772927|Dietary Supplement|Parenteral Nutrition|Protein and energy intakes
16150980|NCT01772901|Other|Influenza Vaccine Intervention|The intervention will include a brief 5 to 10-minute educational talk by research nurse explaining the facts of influenza and influenza vaccine and answering participant questions. The educational intervention will focus on: (1) Hong Kong government's recommendation regarding influenza vaccine during pregnancy, (2) potential complications associated with influenza during pregnancy and for young infants, (3) safety of influenza vaccine for mother and foetus, and (4) potential benefits of influenza vaccine for mother and infant, and (5) where and how to get the influenza vaccine in Hong Kong.
16150981|NCT01772875|Procedure|bladder lavage|the bladder is rinced through the urinary catheter with the lavage solution
16150982|NCT01772862|Behavioral|Intervention group|"The intervention components includes (real time sequence):
~An educational session where the child is educated on his/her cancer disease. An education session in the child's school where the child´s teachers, classmates and their parents are educated on the child´s cancer disease.
~Appointment of two classmates as ambassadors. An individualized physical training program combining supervised and non-supervised training 3-5 times per week.
~Continued specialized physical training when relevant. At two weeks intervals joined education, physical and social activity days at the hospital with together with one of the ambassadors"
16151015|NCT01772628|Behavioral|Classroom-based component|Selected topics about sex, communication, and relationships were integrated in 8 English classroom lessons and 8 Christian Religious Education classroom lessons. The component was implemented in a period of 14 weeks in Senior One classrooms of all the 11 intervention schools.
16150983|NCT01772849|Behavioral|Intervention group|"The intervention components includes (real time sequence):
~An educational session where the child is educated on his/her cancer disease An education session in the child's school where the child´s teachers, classmates and their parents are educated on the child´s cancer disease.
~Appointment of two classmates as ambassadors Continued individualized education at the hospital school or at home that parallels/copies the educational curriculum in the child regular school At two weks intervals joined education, physical (separate study) and social activity days at the hospital with together with one of the ambassadors"
16150984|NCT01772836|Drug|RPX7009|Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo)
16150985|NCT01772836|Drug|Biapenem|Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo)
16150986|NCT01772836|Drug|Normal saline|Up to three (3) cohorts of 10 healthy adult subjects (8 active, 2 placebo)
16150987|NCT01772823|Behavioral|3MV|Many Men, Many Voices (3MV) is based on Social Cognitive Theory and the Transtheoretical Model of Behavior Change. 3MV is a group-level intervention that addresses behavioral and social determinants and other factors influencing the HIV/sexually transmitted infection (STI) risk and protective behaviors of Men having sex with men (MSM) of color. The other factors include cultural, social and religious norms, racial identity and degree of connectedness to communities, HIV/STI interactions, sexual relationship dynamics, and the social influences of racism and homophobia.
16150988|NCT01772823|Behavioral|PCC|Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. Counselors ask the client to recall and describe in as much detail, a recent encounter of unprotected anal sex with another man of unknown or sero-discordant HIV status. The client then identifies and expresses thoughts, feelings, or attitudes that might have led to the high-risk behavior. The client and counselor examine and identify thoughts that may have led the client to decide to engage in high transmission risk sex. The client and counselor agree on strategies that can be used to deal with similar situations in the future.
16150989|NCT01772823|Drug|Emtricitabine/tenofovir (FTC/TDF (Truvada®))|All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
16150990|NCT01772810|Drug|Human spinal cord stem cells.|Human spinal cord stem cell implantation in paralysis patients due to a spinal cord injury.
16150991|NCT01772797|Drug|LDK378|LDK378 is a capsule to be taken daily by mouth.
16150992|NCT01772797|Drug|AUY922|AUY922 is an intravenous infusion that will be administered by the investigative site to the patient on a weekly basis.
16150993|NCT01772784|Other|Phenolic acids|Phenolic acids
16150994|NCT01772771|Procedure|Biospecimen Collection|Undergo collection of blood, saliva/buccal swab samples
16150995|NCT01772771|Other|Genetic Testing|Correlative studies
16150996|NCT01772771|Other|Medical Chart Review|Review of medical records
16150997|NCT01772758|Drug|BH4 5mg|Kuvan® or sapropterin dihydrochloride is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Subjects received an oral dose of 5 mg/kg of Kuvan® (Biomarin Pharmaceuticals Inc.)
16150998|NCT01772758|Drug|BH4 20mg|Kuvan® or sapropterin dihydrochloride is a synthetic preparation of the dihydrochloride salt of naturally occurring tetrahydrobiopterin (BH4). Subjects received an oral dose of 20 mg/kg of Kuvan® (Biomarin Pharmaceuticals Inc.)
16150999|NCT01772758|Dietary Supplement|Antioxidant Cocktail|Vitamin C (1000 mg) , Vitamin E (600 IU) , and alpha-lipoic acid (600 mg). all BID
16151000|NCT01772745|Procedure|SILS cholecystectomy|Single incision laparoscopic cholecystectomy will be performed
16151001|NCT01772745|Procedure|TPCL cholecystectomy|Three port laparoscopic cholecystectomy will br performed
16151002|NCT01772732|Drug|Simotinib Hydrochloride|
16151003|NCT01772719|Drug|Simvastatin and zoledronic acid|"Simvastatin 80 mg PO daily starting two days before starting chemotherapy and stopping two days after chemotherapy.
~Zoledronic acid 4 mg IV over 15 minutes on day 1 and then monthly."
16151004|NCT01772706|Procedure|low level laser therapy|
16151005|NCT01772706|Procedure|placebo (laser low level energy nonfunctional)|
16151006|NCT01772693|Device|ExAblate Transcranial MRgFUS|ExAblate Transcranial MR Guided Focused Ultrasound
16151007|NCT01772693|Device|Sham ExAblate Transcranial MRgFUS|Sham ExAblate Transcranial MR Guided Focused Ultrasound
16151008|NCT01772680|Dietary Supplement|Zinc Supplementation|25 mg elemental zinc taken as zinc sulfate in capsule form taken daily for 3 months
16151009|NCT01772667|Procedure|Inpatient Rehabilitation|"Rehabilitation program in Schoen Klinik Berchtesgadener Land"
16151010|NCT01772654|Device|Arterial Spin Labeled (ASL) MRI sequence|"The Arterial Spin Labeled (ASL) MRI sequence is an MRI technique in which arterial blood undergoes spatially selective inversion to label the arterial blood.
~This is a magnetic technique and does not require contrast. The tagged blood is imaged and areas of hypoperfusion or hyperperfusion are revealed on the MRI sequence."
16151011|NCT01772641|Other|Scheduled Gradual Reduction + Varenicline|Participants will receive a four-week Scheduled Gradual Reduction (SGR) intervention in which participants cut down on the number of cigarettes smoked. This is done through a smoking schedule in which participants smoke a cigarette at given fixed and equal intervals throughout their waking day. Additionally, they will take 0.5 mg of Varenicline (VN) once a day for the first three days, then 0.5 mg twice a day for the next four days, and they will continue for 13 weeks at 1.0 mg twice per day.
16151012|NCT01772641|Other|Scheduled Gradual Reduction + Placebo Drug|Participants will receive a four-week Scheduled Gradual Reduction (SGR) intervention in which participants cut down on the number of cigarettes smoked. This is done through a smoking schedule in which participants smoke a cigarette at given fixed and equal intervals throughout their waking day. Additionally, they will take placebo pills matching the schedule of the VN group.
16151013|NCT01772641|Other|Basic Advice + Varenicline|Participants will receive informational pamphlets with advice about quitting smoking. Additionally, they will take 0.5 mg of Varenicline (VN) once a day for the first three days, then 0.5 mg twice a day for the next four days, and they will continue for 13 weeks at 1.0 mg twice per day.
16151014|NCT01772641|Other|Basic Advice + Placebo Drug|Participants will receive informational pamphlets with advice about quitting smoking. Additionally, they will take placebo pills matching the schedule of the VN group.
16151275|NCT01770392|Drug|Rifampicin|single dose once daily for 7 days
16151016|NCT01772628|Behavioral|STI/HIV prevention education|"For this component, the project partnered with Naguru Teenage information and Health Centre a local NGO providing youth friendly Sexual Reproductive Health services. The STI/HIV prevention education was implemented once in each school on a day that had been agreed upon with the school administration."
16151017|NCT01772628|Behavioral|Homework assignment component|This component was to facilitate open parent-child interactions and encourage interpersonal learning in a friendly home environment about selected Sexual Reproductive Health issues. Homework assignments were developed on the basis of the topics covered in the learners' component. Students were asked to discuss each assignment with their parents/guardians and recorded answers in 32 paged exercise books provided by the project which were eventually handed over to the researchers at the end of the intervention. Students were given 8 English homework assignments and 7 Christian Religious Education homework assignments.
16151018|NCT01772628|Behavioral|Parenting component|Three one day parenting workshops were conducted in each of the 11 schools for parents/guardians during the period in which the lessons were being implemented. First workshop was conducted at the beginning of the intervention, the second in the middle of the intervention and the third at the end of the intervention. Each workshop in a school was facilitated by one selected teacher and one selected parent in the school. In the first workshop a brochure about the intervention was distributed to all the parents/guardians in attendance.
16151019|NCT01772615|Drug|Ciprofloxacin|Antibiotic
16151020|NCT01772615|Dietary Supplement|E. coli Nissle|Probiotic
16151021|NCT01772589|Procedure|New saw blade|
16151022|NCT01772589|Procedure|Reprocessed saw blade|
16151023|NCT01772576|Device|Reliance 4-Front lead implantation|The patients selected for participation should be from the investigator's general patient population with an indication for implantation of a single or dual chamber ICD or CRT-D system.
16151024|NCT01772563|Drug|volasertib|cycle in 21 days
16151025|NCT01772563|Drug|itraconazole|over 18 days
16151026|NCT01772550|Device|20GA BD Nexiva Diffusics|"The Inserter will have a single attempt on each arm (antecubital area) in which to insert the study catheter. If the catheter is not successfully inserted on the first attempt, the Inserter may make a second attempt in the contralateral arm.
~If the Inserter is unsuccessful in the second attempt, the subject is to be discontinued from the Study, and additional (non-Study) insertion attempts may be made according to facility policies."
16151027|NCT01772550|Device|18GA Conventional Catheter|"The Inserter will have a single attempt on each arm (antecubital area) in which to insert the study catheter. If the catheter is not successfully inserted on the first attempt, the Inserter may make a second attempt in the contralateral arm.
~If after the first attempt, there is no vein in the contralateral arm that can accommodate an 18 gauge catheter, the subject is to be discontinued from the Study, and additional (non-Study) insertion attempts may be made according to facility policies."
16151028|NCT01772537|Drug|Propofol|Intravenous anesthetic
16151029|NCT01772537|Drug|isoflurane|
16151030|NCT01772524|Biological|ALD403|
16151031|NCT01772524|Drug|Placebo|
16151032|NCT01772511|Behavioral|Questionnaire|All patients entering on this trial will have been enrolled on an oncology clinical trial and are receiving active anti-cancer treatment on that study.
16151033|NCT01772498|Behavioral|heart rate variability biofeedback|
16151034|NCT01772485|Behavioral|Cognitive Training|The training comprises a suite of 26 engaging, performance-adaptive, and rewarding training modules that provide 30 hours of rigorous neuroplasticity-based cognitive training for children with ADHD addressing deficits in core cognitive domains of alertness, selective attention and working memory of goal-relevant information, control of impulsive actions and suppression of distracting information.
16151035|NCT01772485|Behavioral|Active Control|Participants will engage in any 4 of 13 suite games (visual tiled puzzles, word games etc.) from the Hoyle Puzzle and Board games program. Suite games are randomly assigned in each session.
16151036|NCT01772472|Drug|trastuzumab|6 mg/kg intravenously every 3 weeks, 14 cycles
16151037|NCT01772472|Drug|trastuzumab emtansine|3.6 mg/kg intravenously every 3 weeks, 14 cycles
16151038|NCT01772446|Behavioral|SMS MESSAGING|SMS MESSAGING TO MOBILE PHONE TO REMEMBER THE NEXT CONTROL OF GLYCATED DIABETES
16151039|NCT01772433|Dietary Supplement|Olive oil|Phonophoresis with Olive oil for 10 day, daily
16151040|NCT01772433|Drug|Phonophoresis gel|Phonophoresis with base gel for 10 days, daily
16151041|NCT01772420|Drug|Eltrombopag Olamine|Given PO
16151042|NCT01772420|Other|Laboratory Biomarker Analysis|Correlative studies
16151043|NCT01772420|Drug|Lenalidomide|Given PO
16151044|NCT01772394|Behavioral|Cognitive Remediation Therapy|Cognitive remediation therapy (CRT) is an intensive training cognitive therapy that encourages people to reflect on and try to modify the way they think, with a particular focus on improving cognitive flexibility. It is a manualised therapist-led intervention consisting of multiple versions of a variety of tasks and mental exercises that address the difficulties in flexibility and holistic processing. CRT is an individual 10-sessions long program (2 sessions per week).
16151045|NCT01772394|Behavioral|Sham Therapy|The Sham therapy (ST) has been designed to match the CRT format: an individual manualised therapist-led 10-sessions long program (2 sessions per week). ST sessions have been designed so as to avoid set-shifting and central coherence training. Rather, ST is a manualised sham intervention consisting of multiple exercises on 3 domains: soft physical activity, emotional expression recognition and interpersonal functioning.
16151046|NCT01772381|Drug|Dexamethasone|Long acting corticosteroid
16151047|NCT01772368|Drug|Fp MDPI|"Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened.
~Fp at 100 mcg was an active comparator (single dose). Further, participants were instructed to administer two inhalations of Fp MDPI 50 mcg twice daily (100 mcg total dose) during the Run-in (to replace the participant's current inhaled corticosteroid) and Washout Periods between treatments."
16151048|NCT01772368|Drug|FS MDPI|FS MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate and salmeterol xinafoate dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened. The fluticasone propionate component was a fixed dose of 100 mcg. The salmeterol xinofoate dosage varied: 6.25, 12.5, 25 or 50 mcg.
16151049|NCT01772368|Drug|Advair Diskus|ADVAIR DISKUS (100/50 mcg fluticasone propionate/salmeterol xinafoate) consists of a dry powder formulation of fluticasone propionate and salmeterol xinafoate in a lactose excipient. The dry powder is contained within individual blisters on a double foil strip within the device. Activation of the device opens a single blister of medication which is then dispersed into the air-stream by patient inhalation.
16151050|NCT01772368|Drug|Albuterol|Albuterol (Pro-Air) hydrofluoroalkane (HFA) metered dose inhaler (MDI), was provided to be used as needed for the relief of asthma symptoms during both the run-in and treatment periods (to replace the subject's current rescue medication).
16151051|NCT01772355|Device|semi automated core needle biopsy of orbital tumors|
16151052|NCT01772342|Other|HEPA filtration|Night time air purification with the PureNight air purification system with the HEPA filter in place
16151053|NCT01772342|Other|SHAM|Night time air purification with the PureNight air purification system with the HEPA filter removed
16151054|NCT01772329|Other|Cognitive Therapy|CT will be used as a preemptive treatment in an effort to minimize the effects of catastrophic thinking.
16151055|NCT01772329|Other|Routine Care|Routine Care. No Cognitive Therapy Intervention
16151056|NCT01772316|Drug|tocilizumab|162 mg subcutaneously weekly or every two weeks, 96 weeks
16151057|NCT01772303|Drug|HO/03/03 10-40 µg|HO/03/03 10-40µg once daily (Topically) for up to 24 weeks.
16151058|NCT01772290|Drug|fluconazole|Multiple oral doses
16151059|NCT01772290|Drug|itraconazole|Multiple oral doses
16151060|NCT01772290|Drug|rabeprazole|Multiple oral doses
16151061|NCT01772290|Drug|vismodegib|Multiple oral doses
16151062|NCT01772264|Drug|PF-05089771|titration from 150mg BID to 450mg BID
16151063|NCT01772264|Drug|Placebo|matched placebo
16151064|NCT01772251|Drug|Oshadi Icp|
16151065|NCT01772238|Drug|400 mg Amoxicillin + 57 mg Clavulanic Acid/ 5 ml|Reference product
16151066|NCT01772238|Drug|400 mg Amoxicillin + 57 mg Clavulanic Acid/ 5 ml|Test product
16151067|NCT01772225|Other|Data collection|Medical record abstraction form and patient survey questionnaire.
16151068|NCT01772212|Drug|Terbinafine 250 mg|Test product
16151069|NCT01772212|Drug|Terbinafine 250 mg|Reference product
16151070|NCT01772199|Drug|GSK239512|White to almost white, round tablets. Once daily orally, started at 10 mcg and titrated to the maximum tolerated dose, Up to the highest dose of 80 mcg (10 mcg first week, 20 mcg second week, 40 mcg third week, 80 mcg fourth week) followed by 44 week maintenance treatment period
16151071|NCT01772199|Drug|Placebo|White to almost white, round tablets. Once daily orally.
16151072|NCT01772186|Device|Real-time somatosensory cue|A novel sensory cue proposed in this study, which designed to facilitate weight shift during freezing-of-gait episodes. This sensory cue is controlled by the real-time analysis of gait pattern, and given only when freezing-of-gait detected.
16151073|NCT01772173|Other|Vessel measurements|Measurement of retinal vessels
16151074|NCT01772160|Other|Data collection|HZ/PHN booklet, HZ/PHN file and logbook. HZ/PHN booklet will be completed by the patient and the HZ/PHN file and logbook will be completed by the participating general practitioner.
16151075|NCT01772147|Drug|Umeclidinium bromide 62.5mcg|Inhalation powder
16151076|NCT01772147|Drug|Umeclidinium bromide 125mcg|Inhalation powder
16151077|NCT01772147|Drug|Fluticasone propionate 250mcg/Salmeterol 50mcg|Inhalation powder
16151078|NCT01772134|Drug|Umeclidinium bromide 62.5mcg|Inhalation Powder, LAMA 62.5mcg
16151079|NCT01772134|Drug|Umeclidinium bromide 125mcg|Inhalation Powder, LAMA 125mcg
16151080|NCT01772134|Drug|Fluticasone propionate 250mcg/Salmeterol 50mcg|Inhalation Powder, ICS/LABA
16151081|NCT01772134|Drug|Placebo|Inhalation Powder, Placebo
16151082|NCT01772108|Device|MitraClip|The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
16151083|NCT01772082|Behavioral|Internet mediated walking program|
16151084|NCT01772056|Drug|Fluticasone, cream|Experimental Group: on treatment with twice weekly on consecutive days FP cream of 0.05% for 16 weeks or at relapse
16151085|NCT01772056|Drug|Placebo,|Control Group: on treatment with twice weekly on consecutive days vehicle cream for 16 weeks or at relapse.
16151086|NCT01772030|Other|Use of the Achieve catheter followed by ICE-guided mapping catheter|
16151087|NCT01772017|Device|Tongue Advancement Retainer Device|Tongue Advancement Retainer Device
16151088|NCT01772004|Drug|Avelumab|Avelumab will be administered in study location using a protocol-defined dose escalation scheme until confirmed progression, unacceptable toxicity, or if any criterion for withdrawal from the trial or investigational medicinal product occurs. After determination of the dose and regimen for Expansion Phase, avelumab will be administered to subjects divided into 4 primary cohorts: Non-small cell lung cancer (NSCLC) post platinum doublet, NSCLC first-line, gastric/gastroesophageal junction (GEJ) cancer and metastatic breast cancer (MBC); 8 secondary cohorts: Colorectal cancer (CRC), castrate-resistant prostate cancer (CRPC), melanoma, ovarian cancer, adrenocortical carcinoma (ACC) mesothelioma, urothelial carcinoma, and renal cell carcinoma (RCC); and 4 efficacy expansion cohorts: gastric and GEJ cancer (third line), ovarian cancer (second-line only), urothelial carcinoma, and head and neck squamous cell carcinoma (HNSCC).
16151089|NCT01771991|Drug|Topical Sodermix Dismutase in the form of Sodermix (SOD)|Topical Sodermix Dismutase in the form of Sodermix (SOD) will be applied twice daily, of half dollar application for 12 weeks to fibrosed area.
16151090|NCT01771991|Drug|Placebo|Placebo or cetaphil cream will be applied twice daily, of half dollar size for 12 weeks to fibrosed area.
16151091|NCT01771978|Drug|Placebo|Received 250 ml of a 5% dextrose solution as placebo
16151092|NCT01771978|Drug|Diltiazem|Received a 100 µg/kg bolus followed by a 0.3 µg/kg infusion diluted in 250 ml of 5% dextrose solution
16151093|NCT01771978|Drug|Acetylcystein|Received 150 mg/kg acetylcystein diluted in 250 ml of 5% dextrose solution
16151094|NCT01771978|Drug|diltiazem and acetylcystein|"Received a combination of drug :diltiazem and acetylcystein
~bolus diltiazem 100 µg/kg followed by a 0.3 µg/kg infusion diluted in 125 ml of a 5% dextrose solution
~150 mg/kg acetylcystein diluted in 125 ml of 5% dextrose solution"
16151132|NCT01771640|Biological|intrathecal injection|Intrathecal injection of mesenchymal stem cells in patients with ALS
16151133|NCT01771627|Drug|varenicline|Given PO
16151095|NCT01771965|Behavioral|CB Intervention|The Cognitive Behavioral (CB) intervention is a brief, manualized, tailored one-on-one single session lasting 45-60 minutes and administered by phone. An individual format was chosen to reduce the potential discomfort of stigma of individual concerns in the presence of others. The intervention targets a change in the beliefs that influence whether or not someone enters mental health or substance use treatment. During the session, participants will be given a brief introduction to CBT and informed that CBT is based on the theory that cognitions (i.e., thoughts/beliefs), feelings and behaviors all interact with each other;101, 102 therefore, thoughts about certain situations or things influence behavior. Since thoughts are modifiable, changing thoughts about situations may change behavior.
16151096|NCT01771952|Device|Synvisc-One™|A single 6cc injection of Synvisc-One™ will be utilized in this study.
16151097|NCT01771952|Other|Sham Treatment|A single needle stick without arthrocentesis or injection.
16151098|NCT01771939|Procedure|25-G vitrectomy and phacoemulsification|25-G vitrectomy with Internal Limiting Membrane peeling and phacoemulsification (cataract intervention)
16151099|NCT01771939|Procedure|phacoemulsification (cataract surgery)|lens extraction after phacoemulsification and intra-ocular artificial lens implantation
16151100|NCT01771926|Other|potatoes|Daily intake of assigned treatment for 8 weeks
16151101|NCT01771926|Other|other carbohydrate|Daily intake of assigned treatment for 8 weeks
16151102|NCT01771913|Genetic|centrifuged fat graft|fat from the abdominal subcutaneous tissue will be taken by vacuum assisted lipectomy and immediately prepared to be grafted in the reconstructed breast that presents contour irregularities and/or volume insufficiency. No adipose derived stem cells will enrich the fat grafts in this group.
16151103|NCT01771913|Genetic|ADSCs enriched fat graft|fat from the abdominal subcutaneous tissue will be taken by suction assisted lipectomy and stromal vascular fraction will be isolated and immediately added to the fat graft that will be employed to improve contour irregularities and volume insufficiency of reconstructed breasts.
16151104|NCT01771900|Behavioral|Heart Camp Group|In Week 1, 2, and 3 subjects will attend the HEART CAMP. Subjects will set specific exercise goals. Subjects will be taught how to record exercise data on the computer at the exercise facility. Specific activities will teach subjects aerobic and resistance training exercises and build self-efficacy to exercise. During the period from month 3 to the end of study subjects will continue the training program independently and no formal sessions will be scheduled.
16151105|NCT01771900|Behavioral|Attention Control Group|Subjects will receive a 60 minute group session led by a specifically designated control group intervention nurse. Phone calls will be placed to the subject if they miss a Friday group session and attendance to meetings will be encouraged.
16151106|NCT01771887|Behavioral|education program|education program in 6 hours and monitoring phone every 15 days
16151107|NCT01771874|Drug|MDMA|125 mg per os, single dose
16151108|NCT01771874|Drug|Bupropion|Bupropion will be administered in a dose of 150mg (Wellbutrin XR) once-daily in the morning for three days followed by 300mg (2x150mg) for 4 days before the test day. On the test day, a final dose of 300mg will administered 2 hours before the administration of MDMA 125 mg or placebo.
16151109|NCT01771874|Drug|Placebo|per os
16151110|NCT01771861|Other|Trauma team activation|When admitting a potentially seriously injured patient, a trauma team is activated when prehospital information fulfills one or more prespecified criteria. The trauma team consist of a group of medical personnel including a surgeon, anesthesiologist and radiologist.
16151111|NCT01771848|Biological|PfSPZ Challenge|Aseptic, purified, vialed, cryopreserved fully infectious NF54 P. falciparum sporozoites
16151112|NCT01771822|Drug|Ibuprofen 5% topical gel|0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions
16151113|NCT01771822|Drug|Topical gel vehicle|0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions
16151114|NCT01771822|Drug|Sodium lauryl sulfate 0.2%|0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions
16151115|NCT01771822|Drug|Sodium chloride solution 0.9% (saline)|0.2 ml applied daily for 21 days over 3 weeks under occlusive conditions
16151116|NCT01771809|Drug|75mg SHP647 (PF-00547659)|75 mg sterile liquid injected subcutaneously every 4 weeks.
16151117|NCT01771809|Drug|225mg SHP647 (PF-00547659)|225 mg sterile liquid injected subcutaneously every 4 weeks.
16151118|NCT01771796|Behavioral|Aerobic and muscle resistance training|After having been allocated randomly to one of the two groups, patients of Intervention Group are encouraged to follow a training program (aerobic and endurance muscle training) during 8 weeks.
16151119|NCT01771783|Drug|ACEI-ARB-RI|
16151120|NCT01771783|Drug|ARB-RI-ACEI|
16151121|NCT01771783|Drug|RI-ACEI-ARB|
16151122|NCT01771731|Drug|Cannabis|
16151123|NCT01771718|Device|MPTflex-multiphoton microscopy-based tomograph.|non-invasive optical biopsy
16151124|NCT01771705|Other|Dose adjust group (NFAT)|If the average residual expression of the 3 cytokines is <20%, the CNI daily dose will be reduced by 15%. If the average residual gene expression of the 3 cytokines is > 60% the CNI daily dose will be increased by 15%.
16151125|NCT01771692|Other|Extraction|Extraction of teeth in the lower arch as part of the orthodontic treatment plan
16151126|NCT01771692|Other|Non extraction|Non extraction in the lower arch as part of the orthodontic treatment plan
16151127|NCT01771679|Biological|Allogeneic Mesenchymal Bone Marrow Cells|Subjects in Part 1, Cohorts 1-3 will receive a 1550 nm Fraxel laser (6-8 mJ, Level 2) treatment on the face followed by a single intravenous infusion of 0.5, 1.0, or 1.5 million mesenchymal cells per kg of body weight, not to exceed 150 million cells. Subjects in Part 2 will receive a 1550 Fraxel laser (6-8 mJ, Level 2) treatment on the face followed by a single intravenous infusion of mesenchymal cells at the Maximum Tolerated Dose, as determined by the safety results of Part 1. The dose in Part 2 is 1.5 million cells per kg, not to exceed a total of 150 million cells.
16151128|NCT01771666|Device|SPY Elite Imaging|A camera that is directed into the axillary cavity to try to capture an image of the tumor site labeled with Indocyanine green before and after excising sentinel nodes
16151129|NCT01771666|Drug|Indocyanine Green|"started at 1mg /mL
~If fluorescence is not detected with this dose, then it will be increased by 50%."
16151130|NCT01771666|Drug|Isosulfan blue|"3 to 5 mL
~If fluorescence is not detected with this dose, then it will be increased by 50%."
16151131|NCT01771666|Drug|99technetium-sulfur colloid radiolabel|
16151134|NCT01771627|Drug|nicotine patch|
16151139|NCT01771575|Device|PoNS™ device|The PoNS™ device uses electrotactile waveform in conjunction with the Cranial Nerve - Non-Invasive NeuroModulation (CN-NINM) intervention. This involves using both balance and gait training methods to stabilize symptoms, regain balance & gait, and affect the functional transfer of improved stability and mobility to activities of daily living. It is based on a body of work focused on developing the tongue-based human-machine interface and application of this technology for balance, vision, and auditory substitution and more recently as neuromodulation for brain rehabilitation after injury and disease.
16151140|NCT01771536|Other|Decision Aid|
16151141|NCT01771523|Procedure|Thyroidectomy|total thyroidectomy or lobectomy
16151142|NCT01771523|Device|use of drain|drain will be used
16151143|NCT01771497|Device|Koning Breast CT|Koning Breast CT scans will be assessed at the beginning, mid-point and end of therapy.
16151144|NCT01771484|Device|External automated abdominal binder|Participants will wear the abdominal compression binder on day 4 or 5 of the study diet. Seated and standing vitals will be collected before and during application of binder.
16151145|NCT01771471|Biological|NuQu|Allogenic juvenile chondrocytes (NuQu) in fibrin carrier.
16151146|NCT01771471|Other|Placebo|0.9% w/v Sodium Chloride for Injection, USP
16151147|NCT01771458|Drug|Targeted therapy based on molecular profiling : Imatinib|
16151148|NCT01771458|Procedure|Tumor biopsy|
16151149|NCT01771458|Drug|Standard Chemotherapy|
16151150|NCT01771458|Drug|Targeted therapy based on molecular profiling : Everolimus|
16151151|NCT01771458|Drug|Targeted therapy based on molecular profiling : Vemurafenib|
16151152|NCT01771458|Drug|Targeted therapy based on molecular profiling : Sorafenib|
16151153|NCT01771458|Drug|Targeted therapy based on molecular profiling : Erlotinib|
16151154|NCT01771458|Drug|Targeted therapy based on molecular profiling : Lapatinib + Trastuzumab|
16151155|NCT01771458|Drug|Targeted therapy based on molecular profiling : Dasatinib|
16151156|NCT01771458|Drug|Targeted therapy based on molecular profiling : Tamoxifen (or letrozole if contra-indication)|
16151157|NCT01771458|Drug|Targeted therapy based on molecular profiling : Abiraterone|
16151158|NCT01771445|Drug|IL-1Ra|100mg, s.c, once only
16151159|NCT01771445|Drug|Placebo|100mg, s.c., once only
16151160|NCT01771432|Drug|Antibiotic treatment|Kidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics
16151161|NCT01771432|Other|No treatment|Kidney transplant recipients with asymptomatic bacteriuria will be followed without antibiotic therapy
16151162|NCT01771419|Device|Loop-tip wire (Cook Medical) for the cannulation of the CBD|
16151163|NCT01771419|Device|Cannulotome CT-25mm Cook Medical|
16151164|NCT01771406|Drug|Nebivolol|8 weeks of Nebivolol treatment (5mg/day)
16151165|NCT01771406|Device|Continuous positive airway pressure (CPAP)|8 weeks of CPAP treatment
16151166|NCT01771393|Device|CBCT prior to MDCT|Cone-beam scanner is performed immediately after arthrography, then multidetector scanner is performed.
16151167|NCT01771393|Device|MDCT prior to CBCT|Multidetector scanner is performed immediately after arthrography, then Cone-beam scanner is performed.
16151168|NCT01771367|Biological|Fluad|
16151169|NCT01771367|Biological|Agrippal|
16151170|NCT01771367|Biological|Placebo|
16151171|NCT01771354|Biological|Engerix B Vaccine|
16151172|NCT01771354|Biological|Placebo|
16151173|NCT01771341|Device|MAQUET SERVOi ventilator with Edi Catheter|NAVA respiratory modality
16151174|NCT01771341|Device|MAQUET SERVOi ventilator|Pressure Support
16151175|NCT01771328|Drug|Hydrocortisone|Initial standard dose of 10mg/m2/24hrs administered by pump during the treatment period, it will take 4 months. Body surface area will be calculated according to the nomogram from the formula of Du Bois and Du Bois.
16151176|NCT01771328|Drug|Cortisone acetate|Patients will take this tables two times during day according to best clinical practice of therapy of congenital adrenal hyperplasia. Usually Cortisone 25 mg 1 tbl. in the morning and Cortisone 25 1/4 tbl. in the evening. This period will take 6 months.
16151177|NCT01771315|Behavioral|Telephone follow-up|The consultation is structured by predefined themes relevant for identifying health related problems in regard to illness to give adequate education and counseling. The form of each consultation will vary according to the individual needs of the patients.
16151178|NCT01771302|Device|Bio-Oss|It is a bone substitute of bovine origin
16151179|NCT01771302|Device|calcium phosphate ceramic|It is a synthetic bone substitute ceramic that is composed of calcium and phosphate ions and prepared at high temperature
16151180|NCT01771289|Drug|docetaxel/cisplatin|weekly docetaxel/cisplatin combined with radiation
16151181|NCT01771289|Radiation|Radiation|chemoradiation
16151182|NCT01771276|Device|g-Cath Suture Anchor Delivery Catheter|Evaluate changes in emptying, hormones, satiety and weight loss with use of the g-Cath Suture Anchor Delivery Catheter in maximizing g-Cath Suture Anchor placement to as high as 25 anchors.
16151183|NCT01771263|Device|iControl-RP|
16151184|NCT01771250|Biological|Insulin Peglispro|Daily doses administered SC.
16151185|NCT01771250|Biological|Insulin Glargine|Daily doses administered SC.
16151186|NCT01771237|Behavioral|MyPeeps Manualized Group Intervention|Topics include: HIV/STI transmission, interpersonal communication, stigma management, condom use, substance use and risky sex, HIV-related harm reduction
16151187|NCT01771237|Behavioral|Standard Sexual Health Education|Topics include: HIV/STI transmission facts, myths regarding HIV transmission, information on effectiveness of condom use
16151188|NCT01771224|Dietary Supplement|Palmitoleic acid|Palmitoleic acid and 5-ASA
16151189|NCT01771211|Device|tDCS|anodal tDCS will be delivered with a constant current of 1 mA during resting-state and task-related fMRI and will continue until the end of the word-generation task. For both stimulation conditions (atDCS, sham) the current will be initially increased in a ramp-like fashion over 10 s, eliciting a tingling sensation on the scalp that fades over seconds. During sham stimulation the current will be turned off after 30 s.
16151190|NCT01771198|Drug|SIMVASTATIN|SIMVASTATIN tablet of 40mg once a day during 30 days
16151191|NCT01771185|Procedure|Duodenal jejunal bypass plus sleeve gastrectomy|Metabolic Surgery Duodenal jejunal bypass plus sleeve gastrectomy
16151276|NCT01770392|Drug|Nintedanib|single dose administration
16151192|NCT01771185|Drug|Best medical treatment (Metformin ; gliclazide)|Metformin 2 g/day; gliclazide 30 mg
16151193|NCT01771159|Device|TBC|"The anchor is capped and surgically implanted in the extra-peritoneal space of the suprapubic region of pubic hair of the lower abdomen using sutures sandwich and secure the anchor between the rectus abdominis muscle and the detrusor [bladder] muscle. Skin is closed over the implant and the bladder is drained with a Foley urethral catheter. The Phase I implant is left in place for 3+ months to allow fibroblasts and collagen from the adjacent muscles to grow into the porous PTFE and effect robust, water--tight bonding of anchor to both rectus and bladder muscles.
~After a local anesthesia is injected, the remaining components of the TBC are connected forming a water-tight union of the anchor to the urinary bladder."
16151194|NCT01771146|Drug|FOLFIRINOX Regimen|6 cycles of FOLFIRINOX prior to surgical resection: Eloxatin® (Oxaliplatin) 85 mg per square meter 2-hour IV infusion Camptosar® (Irinotecan Hydrochloride) 180 mg per square meter 90-minute IV infusion via Y-connector adrucil (Fluorouracil; 5-FU)2400 mg per square meter 46-hour IV infusion
16151195|NCT01771133|Behavioral|Lifestyle intervention group|The lifestyle intervention will be delivered within an empowerment framework which promotes behavioral changes by facilitating health self-efficacy, utilizing self-praise and using active coping skills to address and manage emotions. A nutrition component primarily focuses on total calories, for which energy requirements will be individually calculated for each pregnant women and on general diet quality with an emphasis on carbohydrate quality. It will also promote an overall healthy diet, emphasizing improvement of fat quality and reducing salt intake. A physical activity component focuses on promoting regular movement and minimizes the duration of bouts of sitting or lying during waking hours as well as non-exercise activity.
16151196|NCT01771120|Other|Diagnostic tests, medical interview and questionnaires|All patients will perform these interventions.
16151202|NCT01771094|Behavioral|Effect of sweetness of the beverage in thirst sensation|"Effect of sweetness of the beverage in thirst sensation:
~The participants will drink Water (control group),High Sucralose - Decarbonized Pineapple Diet Soda with a 50% increase of sucralose face to standard beverage, and Low Sucralose - Decarbonized Pineapple with a 50% decrease of sucralose face to standard beverage. The beverages will be presented chilled but without ice in 500 ml portions in opaque plastic containers and participants will be asked to consume the entire amount within 15 min."
16151203|NCT01771081|Drug|Ranibizumab (or other DME treatment)|Patients with DME having started treatment with an approved anti-VEGF therapy at or after 01 October 2012 and then continuing with this or any kind or no treatment
16151204|NCT01771068|Behavioral|"Triple P Positive Parenting Program Discussion Group Dealing with Disobedience"|
16151205|NCT01771055|Procedure|Galactose|Galactose dripped into the abdomen after surgery
16151206|NCT01771055|Procedure|Standard surgical methods|
16151207|NCT01771042|Other|Dietary weight loss at 25% energy deficit|Dietary weight loss at 25% energy deficit. Dietary macronutrient content will comprise 25% protein, 30% fat and 45% carbohydrate.
16151208|NCT01771003|Device|CellAegis' autoRIC™ Device|Patients in the active group will have the autoRIC device (like a blood pressure cuff) inflated and deflated to a pressure of 200 mmHg in four 5 minute cycles with intervening 5 minutes of reperfusion with the cuff deflated between cycles
16151209|NCT01770990|Behavioral|Tel-PT including mail|Patients receive telephone-based psychotherapy and one letter after each telephone session.
16151210|NCT01770990|Behavioral|Tel-PT without mail|Patients receive telephone-based psychotherapy without additional letters.
16151211|NCT01770977|Device|Light-emitting diode therapy|
16151212|NCT01770977|Device|Placebo light-emitting diode therapy|
16151213|NCT01770964|Drug|Pregabalin|
16151214|NCT01770964|Drug|placebo|
16151215|NCT01770964|Behavioral|Training Type A|
16151216|NCT01770964|Behavioral|Training Type B|
16151217|NCT01770938|Device|Effective light-emitting diode therapy|
16151218|NCT01770938|Device|Placebo light-emitting diode therapy|
16151219|NCT01770925|Device|N-CPAP|"The n-CPAP group will receive at extubation a single level continuous positive airway pressure of 7 cm water for at least 48 hours before weaning is commenced. If the infant is stable for the preceding 48 hours defined by having fewer than three minor apneas and no increase in oxygen requirement, weaning will be permitted.
~CPAP will be decreased from 6 cm water by 1 cm water every 24 hours if tolerated based on the above criteria. This will be done until a pressure of 4 cm water is reached.
~If a pressure of 4 cm water is successfully tolerated for 48 hours then time off n-CPAP will be allowed. Thereafter, no fixed weaning regime based on number of hours in a day the infant will be allowed to come off CPAP will be prescribed."
16151220|NCT01770925|Device|n-BiPAP|"The n-BiPAP group will receive at extubation a mean airway pressure of 7 cm water (positive end expiratory pressure of 5 cm water and peak inspiratory pressure of 9 cm of water). Inspiratory time of one second and respiratory rate of 30/min will always be maintained.
~The infant will then receive a mean airway pressure of 5 cm water (positive end expiratory pressure of 4 cm water and peak inspiratory pressure of 6 cm of water)."
16151221|NCT01770925|Device|NIPPV|The NIPPV group will receive at extubation a positive end expiratory pressure of 5 cm water , a peak inspiratory pressure of 9 cm of water, RR of 35 and ti of 0.32
16151222|NCT01770912|Drug|Lactated Ringers|Solution used for TMJ arthrocentesis procedure. 1 cc of Lactated Ringers solution injected once after the TMJ rinsing procedure.
16151223|NCT01770912|Drug|Triamcinolone hexacetonide|1 cc of triamcinolone hexacetonide (5 mg) injected once after the TMJ rinsing procedure.
16151224|NCT01770899|Drug|Montelukast|
16151225|NCT01770899|Drug|Placebo|Gelatin capsule given every 24 hours
16151226|NCT01770886|Drug|UE2343|Oral capsule
16151227|NCT01770886|Drug|Placebo|Oral capsule
16151228|NCT01770873|Behavioral|Take Charge 2|Youth assigned to the intervention receive a Big Brothers, Big Sisters (BBBS) mentor. During the match process, BBBS staff provide 3 session on violence prevention for the youth's parents. Six months into the mentoring relationship, mentors provide 6 sessions on violence prevention for the youth.
16151404|NCT01769378|Drug|Glimepiride|Administered PO
16151229|NCT01770860|Device|6660|At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.
16151230|NCT01770860|Device|4314|At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.
16151231|NCT01770860|Device|8336|At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.
16151232|NCT01770860|Device|4840|At each daily visit, designated study personnel will replace the specific test product on the assigned wound site.
16151233|NCT01770821|Other|Dietary supplement and/or physical training|
16151234|NCT01770808|Dietary Supplement|AquaCal|AquaCal is produced by Marigot Ltd. The daily dose of 4 capsules of AquaCal provide 800mg calcium, (the EU RDA for calcium) and 74 mgs Magnesium (EU RDA 375mg). Subjects swallowed 4 capsules/day for six weeks.
16151235|NCT01770808|Dietary Supplement|AquaPT|AquaPT is produced by Marigot Ltd according to EU and FDA requirements. The daily dose of 4 capsules of AquaPT provides 720mg calcium, 200mgs green tea (polyphenols) and 50 mgs pine bark extract. Subjects swallowed 4 capsules/day for six weeks.
16151236|NCT01770808|Dietary Supplement|Placebo|Subjects swallowed 4 capsules/day for six weeks.
16151237|NCT01770795|Drug|Genexol-PM/Gemcitabine|
16151238|NCT01770782|Procedure|Surgically Assisted Rapid Maxillary Expansion (SARME)|Surgical technique is performed with subtotal LeFort I osteotomy with separation of the pterygomaxillary fissure.The procedure was performed under general anesthesia using endotracheal intubation. Following the osteotomies, the expander screw was activated to 1.6 mm intraoperatively until a small diastema was observed between the upper central incisors. The incision was sutured along two planes.
16151239|NCT01770782|Other|Laser Scanner|Laser Scanner Vivid 9i was used to digitize the study models. The 3d virtual dental casts is a reliable copy of the original dental casts. On this virtual casts all measurements (linear, area and volume of the palate) was done to evaluate the stability after SARME.
16151240|NCT01770769|Device|Hemi - arthroplasty|modular hemiarthroplasty
16151241|NCT01770769|Device|internal fixation|Two cancellous parallel screws - internal fixation of the femoral neck fracture
16151242|NCT01770756|Behavioral|Self-Care Training|
16151243|NCT01770743|Biological|AV7909|Anthrax Vaccine Adsorbed plus CPG 7909 Adjuvant
16151244|NCT01770743|Biological|BioThrax|
16151245|NCT01770730|Device|Urine LAM strip test|This is a point-of-care lateral flow strip test to detect the presence of lipoarabinomannan (LAM) in patient urine samples. Only patients with a grade 2-5 visual band intensity will be considered positive and commenced on treatment
16151246|NCT01770717|Other|Spatial Frequency Domain Imaging|Assessment of Pressure Ulcer Formation using Spatial Frequency Domain Imaging
16151247|NCT01770691|Device|TIPI vaginal pessary|TIPI vaginal pessary G3 model, and TIPI SMD's
16151248|NCT01770678|Other|Constraint Induced Movement Therapy|A combination of prolonged restraint of the unaffected upper limb and massed practice of the affected upper limb.
16151249|NCT01770652|Drug|Deferiprone|Oral iron chelator
16151250|NCT01770639|Procedure|MFB|Surgical arthrodesis of the midfoot with the Midfoot Fusion Bolt (MFB)
16151251|NCT01770626|Other|Nutrition|Anthropometrics, Nutrition assessment, Bioelectrical Impedance Analysis, Blood sample, Resting Energy Expenditure. All will be done 2-3 weeks after initial study visit and will continue every 3 months study visit except the Resting Energy Expenditure which will be performed at only one visit (2-3 weeks after initial visit).
16151252|NCT01770613|Biological|Stem cells|Allogeneic mesenchymal stem cells
16151253|NCT01770600|Other|placebo|placebo pill administered daily for 5 days
16151254|NCT01770600|Drug|Riperidone|1 mg risperidone administered orally for 5 days
16151255|NCT01770587|Behavioral|Behavioral Insomnia Treatment|
16151256|NCT01770574|Device|ReproBone|Artificial bone graft is inserted as a wedge in the calcaneal lengthening osteotomy
16151257|NCT01770574|Procedure|calcaneal lengthening|Autologous bone graft is harvested from the iliac crest and inserted as a wedge in the calcaneal lengthening osteotomy
16151258|NCT01770561|Device|Integrated sensor and infusion set.|Change patients from current devices to the Integrated sensor and infusion set.
16151259|NCT01770548|Genetic|analysis of the glutamate synapse in autism|Neurophysiological, molecular and developmental analysis of the glutamate synapse in autism
16151260|NCT01770548|Genetic|DNA collection|DNA collection
16151261|NCT01770548|Other|Auditory evoked potentials|auditory evoked potentials
16151262|NCT01770509|Device|NMBM|Daily application of NMBM in addition to compression therapy
16151263|NCT01770509|Other|Compression garments|Compression garments
16151264|NCT01770496|Behavioral|Childhood vaccination reminder / recall notification|
16151265|NCT01770483|Drug|nitazoxanide|nitazoxanide 500mg twice daily
16151266|NCT01770483|Drug|conventional interferon alfa|Inj interferon 3 Million International Units thrice weekly
16151267|NCT01770483|Drug|Ribavirin|ribazole
16151268|NCT01770470|Dietary Supplement|Chitosan|The product chitosan is contained in a chewing gum formulation
16151269|NCT01770444|Other|Low-dose Cardiac CT protocol|"A cardiac CT protocol modified for reduction of radiation exposure
~Prospective gating
~Range: dedicated imaging (below carina to heart base)"
16151270|NCT01770444|Other|Conventional cardiac CT protocol|"Conventional CCTA protocol
~Retrospective gating with tube current modulation
~Range: dedicated imaging (below carina to heart base)"
16151271|NCT01770431|Drug|Huaier Granule|Huaier Granule is a traditional Chinese medicine, 20g / time, 3 times/day,Po.
16151272|NCT01770418|Radiation|Radiation with Concurrent Chemotherapy|"RADIATION: Proton Radiotherapy
~Dose Level 1: 60 Gy (RBE) at 2.5 Gy(RBE) per fraction x 24 fractions
~Dose Level 2: 60 Gy (RBE) at 3 Gy (RBE) per fraction x 20 fractions
~Dose Level 3: 60.01 Gy (RBE) at 3.53 Gy (RBE) per fraction x 17 fractions
~Dose Level 4: 60 Gy (RBE) at 4 Gy (RBE) per fraction x 15 fractions
~CONCURRENT CHEMOTHERAPY:
~Paclitaxel at a dose of 45 mg/m2 and Carboplatin at a dose of AUC 2 mg/min/ml (a total of 3-5 weekly doses) OR Cisplatin 50mg/m2 days 1, 8, 29, and 36 and Etoposide 50mg/m2 days 1-5, 29-33. For non squamous histology, Carboplatin AUC 5 on day 1 and Pemetrexed 500 mg/m2 on day 1 every 21 days OR Cisplatin 75 mg/m2 on day 1 and Pemetrexed 500 mg/m2 on day 1 every 21 days.
~Adjuvant chemotherapy is optional."
16151273|NCT01770405|Device|Endoscopic ultrasound fine needle aspiration|Device: nCLE needle-based Confocal Laser Endomicroscopy
16151274|NCT01770392|Drug|Nintedanib|single dose administration
16151277|NCT01770379|Biological|Secukinumab (AIN457)|"Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a messenger protein in the body) called Interleukin 17 (IL-17)"
16151278|NCT01770379|Biological|Placebo|
16151279|NCT01770366|Device|Weight and Exercise Lifestyle Support (WELS)|Intervention patients will receive a suite of devices manufactured by the FitLinxx company, including their Pebble activity monitor, ActiScale weight scale, and access to their ActiHealth.com patient portal website. Intervention participations will be able to use the features of this website, including widgets displaying their device data as well as challenge invitations to interact with other participants, as desired.
16151280|NCT01770366|Device|Usual Care|
16151281|NCT01770353|Drug|Ferumoxytol|Ferumoxytol 5 mg/kg IV as a single bolus injection, given once.
16151282|NCT01770353|Drug|MM-398|MM-398 IV over 90 min every 2 weeks, until progressive disease or intolerable toxicity
16151283|NCT01770340|Biological|Radical prostatectomy with implantation of allograft|Interposition of resected neurovascular bundles with allograft Avance®
16151284|NCT01770340|Procedure|Radical prostatectomy without implantation of allograft|No interposition of resected neurvascular bundles
16151285|NCT01770327|Behavioral|Effect of ingestion of different Sugary Beverages on Thirst Sensation|The participants will drink Water (control group),Non-fat Milk, Orange Juice and Iced Tea. The beverages will be presented chilled but without ice in 330 ml portions in opaque plastic containers and participants will be asked to consume the entire amount within 15 min.
16151286|NCT01770314|Behavioral|Experimental|Participants will be given instructions via email to review eleven online lessons about opioid medication safety. Instructions will suggest that participants view one lesson per day for eleven consecutive days. Each educational lesson focuses on one or two aspects of medication safety, including how to safely store medication, and the importance of taking medication exactly as prescribed.
16151287|NCT01770301|Drug|Paclitaxel|
16151288|NCT01770301|Drug|Bevacizumab|
16151289|NCT01770288|Other|Anaerobic wingate test|
16151290|NCT01770249|Procedure|Per-oral Endoscopic Esophagomyotomy (POEM)|The surgeon is cutting only through the innermost layers of muscles in the esophagus down to the stomach, leaving the outer layer intact.
16151291|NCT01770236|Drug|IV acetaminophen|Patients randomized to the IV acetaminophen group will receive IV acetaminophen (1000 mg every 6 hours for adults and weight-based for any patient under 50 kg)instead of an On-Q pain pump catheter.
16151292|NCT01770223|Drug|boceprevir|
16151293|NCT01770223|Biological|PegIFN-2b|
16151294|NCT01770223|Drug|RBV|
16151295|NCT01770210|Drug|Patients on atorvastatin treatment|Statins Therapy
16151296|NCT01770197|Drug|IV rt-PA|IV rt-PA treatment
16151297|NCT01770184|Behavioral|Chronic Disease Self-Management Program (CDSMP)|
16151298|NCT01770171|Drug|Bevacizumab|Carboplatin AUC 5+ Paclitaxel 175 mg/mq+Bevacizumab 15 mg/kg q 21 for 6 -8 cycles + Bevacizumab 15 mg/kg
16151299|NCT01770171|Drug|Carboplatin AUC 5+Paclitaxel 175 mg/mq q 21 for 6-8 cycles|Carboplatin AUC 5+Paclitaxel 175 mg/mq q 21 for 6-8 cycles
16151300|NCT01770145|Drug|APOKYN|"Apokyn will be titrated to an optimum dose which reproduces 90% of the subjects' best on UPDRS score during the Initiation Period. During the APOKYN Treatment Period, subjects will inject the dose identified in the initiation period once daily at the time of their normal scheduled L-Dopa dose (L-Dopa will be delayed by 40 minutes)."
16151301|NCT01770145|Drug|L-dopa|Subjects on a stable L-Dopa regimen will be entered into the study. For the L-Dopa Baseline Period through the Initiation Period, subjects will continue their normal L-Dopa dosing regimen. During the APOKYN Treatment Period, subjects will replace their normally scheduled first morning L-Dopa dose with an APOKYN injection, and then administer their normal first morning L-Dopa dose 40 minutes later.
16151302|NCT01770145|Drug|Trimethobenzamide|Following the L-Dopa Baseline Period, subjects will initiate trimethobenzamide treatment TID for a minimum of 3 days during a Anti-Emetic Pretreatment Period. Subjects will continue trimethobenzamide therapy TID through the duration of the APOKYN Initiation Period and APOKYN Treatment Period.
16151303|NCT01770132|Drug|porfimer sodium|Given IV
16151304|NCT01770132|Procedure|endoscopic ultrasonography|Undergo EUS-PDT
16151305|NCT01770132|Procedure|photodynamic therapy|Undergo EUS-PDT
16151306|NCT01770132|Drug|gemcitabine hydrochloride|Given IV
16151307|NCT01770119|Biological|MMR vaccination|Unprotected children will be vaccinated with two MMR vaccines
16151308|NCT01770106|Drug|Denosumab|Subcutaneous injection of denosumab 60mg every 6 months (1 dose for study period)
16151309|NCT01770106|Drug|Alendronate|Alendronate 70mg once weekly
16151310|NCT01770093|Other|Questionnaire|
16151311|NCT01770080|Drug|Euminz®|3 to 5 time topical use of study drug.
16151312|NCT01770080|Drug|Placebo|3 to 5 time topical use of study drug.
16151313|NCT01770067|Drug|CITA-RNPT|
16151314|NCT01770054|Other|obtention of a blood sample|a blood sample will be obtained to measure glucose, HDL cholesterol, triglycerides, and for genetic testing
16151315|NCT01770041|Other|Paracetamol (observation of routine administration)|Normal administration of paracetamol as prescribed by operating surgeon
16151316|NCT01770015|Procedure|biological sampling|cutaneous, rectal, nose and mouth swabs to identify potential fungi colonization
16151317|NCT01770015|Procedure|sampling blood|HLA DR antigen, cytokines (IL 6 and 10), B-glucan
16151318|NCT01770015|Procedure|endotracheal aspiration|fungi and bacteria endotracheal aspiration
16151319|NCT01770002|Procedure|Everted suture technique|
16151320|NCT01770002|Procedure|Non-everted suture technique|
16151321|NCT01769989|Procedure|Electrodermabrasion|
16151322|NCT01769989|Procedure|Dermabrasion|
16151323|NCT01769976|Other|Periodic fasting|
16151324|NCT01769976|Other|Energy restriction|
16151325|NCT01769976|Other|Energy balance diet|
16151326|NCT01769963|Other|Research diet|Participants will be provided specially prepared meals to eat at home for three weeks. During the first week, participants will eat foods that have standard amounts of AGEs in them (this is called the control diet). During the second and third weeks, participants will eat the same foods, only they will be prepared in our kitchen in a way that limits the amount of AGEs in them (called the intervention diet).
16151327|NCT01769950|Other|Choline-PET|Carbon-11 or Fluorine-18 PET-CT will be acquired with a scanner with integrated PET and CT scanning ability at the time of diagnosis. It must be however noted that Choline-PET will not be considered as an alternative to magnetic resonance imaging (MRI). In fact, all patients will undergo MRI too.
16151328|NCT01769937|Drug|H.P. Acthar Gel|Open-label H.P. Acthar Gel given subcutaneous injection once daily for 10 days with potential for additional 5 days of dosing
16151329|NCT01769924|Other|Nephrectomy|Nephrectomy for the purposes of living kidney donation
16151330|NCT01769911|Drug|carmustine|Given IV
16151331|NCT01769911|Drug|cytarabine|Given IV
16151332|NCT01769911|Drug|melphalan|Given IV
16151333|NCT01769911|Drug|etoposide|Given IV
16151334|NCT01769911|Drug|O6-benzylguanine|Given IV
16151335|NCT01769911|Procedure|autologous hematopoietic stem cell transplantation|Undergo transduced and/or non-transduced transplant
16151336|NCT01769911|Procedure|peripheral blood stem cell transplantation|Undergo transduced and/or non-transduced transplant
16151337|NCT01769911|Other|laboratory biomarker analysis|Correlative studies
16151338|NCT01769898|Drug|Formoterol-budesonide|Formoterol-budesonide combined treatment (4.5µg/160µg Q12H)
16151339|NCT01769898|Drug|Theophylline|Theophylline 0.1 Q12H
16151340|NCT01769898|Drug|Placebo|Placebo for theophylline 0.1 Q12H
16151341|NCT01769885|Drug|tivozanib|Given PO
16151342|NCT01769885|Procedure|therapeutic conventional surgery|Undergo nephrectomy
16151343|NCT01769872|Procedure|Autologous Adipose Tissue derived MSCs Transplantation|Intravenous injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 2x10e8 cells / 20mL Intrathecal injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 5x10e7 cells / 2mL Into a spinal cord injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 2x10e7 cells / 1mL
16151344|NCT01769846|Other|Early mobilization protocol|Patients in the treatment group additionally received a cycling exercise session 7 days a week, using a bedside cycle ergometer (MOTOmed Letto 2, RECK-Technik GmbH & Co. KG, Betzenweiler, Germany). The device offers the possibility to conduct passive or active cycling at six levels of increasing resistance. The aim of each session was to have the patient cycle for 30 mins at an individually adjusted intensity level. Patients were placed in a comfortable position in between the supine and the semirecumbent position.
16151345|NCT01769833|Drug|PEG-interferon-Alfa-2A|Pegasys ( PEG-interferon-Alfa-2A) 180mcg / subcutaneous / once-weekly
16151346|NCT01769833|Drug|Nucleosides|
16151347|NCT01769820|Drug|Dexamethasone|studies 1&2:0.75mg twice daily for 5 days, starting on day LH (Luteinising Hormone)+8 of menstrual cycle; Study 3 (adaptive) 0.2,0.4,0.5,0.75,0.8,0.9mg twice daily as above
16151348|NCT01769820|Drug|placebo|
16151349|NCT01769807|Device|CPAP|CPAP adaptation was performed by a sleep technician and the patients were instructed to use this for 1 month.
16151350|NCT01769794|Drug|Western therapy|Physical cooling paste or warm bathing, vitamin B, vitamin C. On the basis of the attending physician's judgment, participants were allowed to use Ibuprofen suspension if their body temperature was greater than 38.5℃. Likewise, the need for antibiotics was determined by the attending physicians. The use of acetaminophen or antibiotics was recorded on the case record form
16151351|NCT01769794|Drug|JET|4g/tablet, One tablet each time (Taken after dissolved in 50ml boiled water, 3 times daily if body temperature≥38.5℃)
16151352|NCT01769794|Drug|Placebo(for JET)|placebos prepared identical in color, taste and consistency to the JET (supplied by Zhongshenghaitian Pharmaceutical, Tianjin, China)
16151353|NCT01769781|Drug|anastrazole|combined treatment with aromatase inhibitor (anastrazole) plus GnRH analog (leuprolide acetate) for three months
16151354|NCT01769781|Drug|GnRH analog alone|treatment for three months with GnRH analog (leuprolide acetate) alone
16151355|NCT01769768|Drug|LDE225|LDE225 800 mg once daily dosing will begin on Cycle 1 Day 1 of a 28-day cycle.Treatment with LDE225 for both groups will continue until the patient experiences unacceptable toxicity that precludes further treatment, disease progression, withdrawal of consent and/or at the discretion of the investigator.
16151356|NCT01769768|Drug|Wafarin|15 mg single dose of warfarin (oral tablet) will be given to patients.
16151357|NCT01769768|Drug|Bupropion|75 mg single dose of bupropion(oral tablet, from an immediate release formulation) will be given to patients
16151358|NCT01769755|Biological|PDA001|"Cohort 1 Dose Level 1: ¼ unit Human Placenta-Derived Cells PDA001 infused a total of 5 times 2 weeks apart.
~Cohort 2 Dose Level 2: ½ unit Human Placenta-Derived Cells PDA001 infused a total of 5 times 2 weeks apart.
~Cohort 3 Dose Level 3: 1 unit Human Placenta-Derived Cells PDA001 infused a total of 5 times 2 weeks apart."
16151359|NCT01769755|Drug|Vehicle Controlled Placebo|"Cohort 1 Dose Level 1: ¼ unit vehicle controlled placebo infused a total of 5 times 2 weeks apart.
~Cohort 2 Dose Level 2: ½ unit vehicle controlled placebo infused a total of 5 times 2 weeks apart.
~Cohort 3 Dose Level 3: 1 unit vehicle controlled placebo infused a total of 5 times 2 weeks apart."
16151360|NCT01769742|Behavioral|Early mobility bundle|
16151361|NCT01769729|Behavioral|PEPP|
16151362|NCT01769729|Behavioral|Care management|
16151363|NCT01769716|Procedure|Umbilical cord blood transplantation|
16151364|NCT01769703|Drug|Dabigatran 110/150 mg BID|Dabigatran will be taken bid for 30 days post enrolment. The dose of dabigatran will be based on patient age and renal function.
16151365|NCT01769690|Other|DBS stimulator setting alteration|"2 sleep study options Phase I: Participants will undergo 2 sleep studies, one with the stimulator on at the subject's stable, clinically effective settings and one with the stimulator off. the order of the off and on nights will be randomized. Although blinding will be attempted, because of the significant motor effects produced with the on setting, participants may be able to tell when the DBS is OFF. In the second phase, the first sleep study night will be with the stimulator OFF. The order of the HIGH, and LOW frequency nights will be randomized 1:1 and balanced across subjects and will occur on the 2nd and 3rd PSG nights.
~Phase II Sleep study evaluation will include three nights of recording: 1) OFF with the stimulator off, 2) HIGH with the stimulator on at the participant's stable and clinically effective settings, and 3) LOW with the stimulator set at a low frequency that uses less energy"
16151405|NCT01769365|Drug|7-day quadruple therapy|pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days
16151366|NCT01769690|Other|virtual reality simulator|"This virtual pedestrian environment is a measure of real-world street-crossing behavior. This simulation is composed of an elevated platform that simulates a curb at a street-side and 3 monitors (arranged in a semi-circle) on which the subject, while wearing headtracker equipment, views the virtual environment of bidirectional traffic. When the subject deems it is safe to cross the virtual street, he/she steps off the platform/curb, which activates crossing of the street by a cartoon representation of the participant. The speed of street crossing by the cartoon is determined by each individual subject's walking speed, which is measured prior to the test."
16151367|NCT01769677|Drug|90 mg dose of the hydrocodone bitartrate extended-release tablet administered as either two 45-mg tablets (Treatment A) or one 90-mg tablet (Treatment B).|Each subject will receive 1 treatment during each administration period. Subjects will receive each of the 2 treatments once. There will be a minimum 14-day washout period between the 2 administrations of study drug. Treatments will be orally administered to subjects, while they are seated, at approximately 0800 (±2 hours) on the 1st day of each administration period.
16151368|NCT01769664|Drug|Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel|Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Taro Pharmaceuticals Inc.) applied once a day in the evening for 77 days (11 weeks)
16151369|NCT01769664|Drug|Duac® Topical Gel|Duac® (Clindamycin 1%/Benzoyl Peroxide 5%) Topical Gel (Stiefel) applied once a day in the evening for 77 days (11 weeks)
16151370|NCT01769664|Drug|Placebo Topical Gel|Placebo (Vehicle) Topical Gel (Taro Pharmaceuticals Inc.) applied once a day in the evening for 77 days (11 weeks)
16151371|NCT01769651|Other|methadone replacement therapy|Patients are prescribed Methadone as part of their treatment plan, having been assessed as having opioid dependence syndrome and requiring pharmacological substitution therapy. A bio-psychosocial approach is taken in the treatment management of individuals.
16151372|NCT01769638|Drug|SPO1101|A single-dose of ODF and FCT formulations of sildenafil given orally in a fasted state (dose: 50mg), with a 7-day washout period between the formulations.
16151373|NCT01769638|Drug|SPO1101D|A single-dose of ODF and FCT formulations of sildenafil given orally in a fasted state (dose: 100mg), with a 7-day washout period between the formulations.
16151374|NCT01769625|Drug|placebo/celecoxib 400 mg and cholecalciferol 400 IU/cholecalciferol 2,000 IU|Take 1 capsule from each bottle (1 bottle containing either placebo/celecoxib and 1 bottle containing either cholecaliferol 400 IU/cholecaliferol 2,000 IU) for 30 days
16151375|NCT01769612|Other|No Intervention|
16151376|NCT01769586|Drug|Diphenhydramine|
16151377|NCT01769586|Drug|Midazolam|
16151378|NCT01769573|Biological|RG-HRV16|A suspension of the RG-HRV16 virus in Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin
16151379|NCT01769573|Drug|Placebo|The placebo to be used will be Minimal Essential Media (MEM, HyClone) containing 0.1% Human Serum Albumin. Placebo will be supplied in 2 ml borosilicate glass vials sealed with butyl stoppers containing 0.5 ml.
16151380|NCT01769560|Behavioral|MeFirst Tailored Intervention|Participants will be lead through MeFirst, an interactive web-based tool that is tailored to their responses during the survey. This tool provides information regarding HPV Vaccination.
16151381|NCT01769547|Drug|Dovitinib|Treatment continued until Disease Progression, Toxicity, or patient withdrawal.
16151382|NCT01769521|Device|Sensimed Triggerfish®|Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
16151383|NCT01769508|Drug|5-Fluorouracil|5-FU, 225 mg/m2 IVCI, during XRT.
16151384|NCT01769508|Drug|Oxaliplatin|Oxaliplatin, 85 mg/m2 IV, Days 1, 15, 29.
16151385|NCT01769508|Drug|Lapatinib|Lapatinib, Continuous PO daily dosing during XRT, dose determined during lead in portion
16151386|NCT01769508|Radiation|Radiation Therapy|Radiation therapy, 50.4 Gy (1.8 Gy/day or 28 fractions) M-F, Weeks1-6
16151387|NCT01769495|Other|2-3 day return appointment|2-3 appointment in geriatric clinic following ED discharge
16151388|NCT01769482|Drug|Udenafil|70 subjects will undergo baseline testing and then be randomized into a clinical parallel trial of udenafil 100mg po q d for 3 months.
16151389|NCT01769482|Drug|placebo|
16151390|NCT01769469|Drug|FTC/TDF (Truvada®)|There are no interventions for this study except that subjects will be administered FTC/TDF (Truvada®) will be administered as part of ATN 110 and ATN 113.
16151391|NCT01769456|Behavioral|PCC|Personalized Cognitive Counseling (PCC) is based on the Model of Relapse Prevention and Gold's Self-Appraisal of Risk Behavior. PCC is a 1-hour, single-session, individual level intervention administered by a trained counselor in a clinic setting. Counselors ask the client to recall and describe a recent encounter of unprotected anal sex with another man of unknown or sero-discordant HIV status. The client then identifies and expresses thoughts, feelings, or attitudes that might have led to the high-risk behavior. The client and counselor examine and identify thoughts that may have led the client to decide to engage in high transmission risk sex. The client and counselor agree on strategies that can be used to deal with similar situations in the future.
16151392|NCT01769456|Drug|Emtricitabine/tenofovir (FTC/TDF (Truvada®))|All subjects will be provided with daily FTC/TDF (Truvada®) as Pre-exposure prophylaxis (PrEP) for 48 weeks.
16151393|NCT01769443|Drug|bortezomib|Bortezomib dosed at 1.3 mg/m^2 as a 3 to 5 second bolus administered by intravenous injection on treatment days 0, 3, 7 and 10. The first dose of bortezomib is administered between 4-8 hours after the first plasmapheresis session is completed and there must be at least 96 hours between the second and third dose of bortezomib.
16151394|NCT01769443|Procedure|plasmapheresis|Plasmapheresis for 3 consecutive days (treatment days 0, 1 and 2) followed by concomitant bortezomib dosed at 1.3 mg/m^2 as a 3 to 5 second bolus administered by intravenous injection on treatment days 0, 3, 7 and 10. The first dose of bortezomib is administered between 4-8 hours after the first plasmapheresis session is completed and there must be at least 96 hours between the second and third dose of bortezomib.
16151395|NCT01769417|Drug|Placebo|Placebo
16151396|NCT01769417|Drug|MEDI4893|Human immunoglobulin G1 kappa monoclonal antibody
16151397|NCT01769404|Biological|LY2605541|
16151398|NCT01769404|Biological|Insulin Glargine|
16151399|NCT01769391|Drug|Necitumumab|Administered IV
16151400|NCT01769391|Drug|Paclitaxel|Administered IV
16151401|NCT01769391|Drug|Carboplatin|Administered IV
16151402|NCT01769378|Drug|Placebo|Administered SQ
16151403|NCT01769378|Drug|Dulaglutide|Administered SQ
16151406|NCT01769365|Drug|10-day sequential therapy|pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days
16151407|NCT01769365|Drug|7-day standard triple therapy|pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days
16151408|NCT01769352|Drug|PredA + Kelac|At week 12, patients will be determined to be resolved, improving/stabilized or treatment failures. Patients who have complete resolution of edema will begin treatment withdrawl. Improving/stabilizing patients will maintain current therapy. Treatment failure Group 2 patients will move to Group 3 to receive PredA q1h WA + Kelac qid starting at week 12. Treatment failure Group 1 patients will be exited from the trial so that alternative therapy can be given.
16151409|NCT01769339|Drug|Miconazole plus Hydrocortisone|Participants will apply miconazole plus hydrocortisone cream topically to the lesion twice daily up to Day 14 by rubbing gently until it has been completely penetrated into the affected vulvar (the tissues around the opening to the vagina) area and the treatment should be continued without interruption. Participants will be assessed for signs and symptoms of vulvar candidiasis at Day 14. Medication will be continued till Day 28, if signs and symptoms of vulvar candidiasis are not cured clinically on Day 14.
16151410|NCT01769326|Other|Conventional hand exercise|Conventional hand exercise consists of passive and active range of motion exercise, and simple coordination exercises with the fingers
16151411|NCT01769326|Device|MusicGlove|The MusicGlove is a glove that detects different grip types. Subjects play a musical game by completing different grips.
16151412|NCT01769326|Other|Conventional Arm Exercise|Conventional arm exercise consists of passive and active range of motion exercise, and simple weight bearing exercises
16151413|NCT01769326|Device|Resonating Arm Exerciser|The RAE is a lever that attaches to a manual wheelchair with elastic bands and can be pushed back and forth to exercise the arm.
16151414|NCT01769313|Device|Laser-assisted cataract surgery|The anterior capsulotomy and lens fragmentation will be performed by means of femtosecond laser surgery
16151415|NCT01769313|Device|Manually performed cataract surgery|The anterior capsulotomy and lens fragmentation will be performed manually.
16151416|NCT01769300|Behavioral|Clinical decision support for medication titration|Electronic health record-based clinical decision support for ADHD medication titration.
16151417|NCT01769274|Drug|PF-05089771|A single oral dose of PF-05089771 1600 mg solution to be administered on Day 1 of each treatment session. There are 2 treatment sessions, therefore 2 single oral doses of PF-05089771 will be adminstered.
16151418|NCT01769274|Drug|Placebo|Placebo for PF-05089771 1600 mg solution administered in each treatment session. There are 2 treatment sessions, therefore 2 single oral doses of placebo will be administered.
16151419|NCT01769261|Other|eligible, Internet|Patients randomized in the internet arm. They will directly complete their health evolution after hospital discharge via the internet.
16151420|NCT01769261|Other|eligibles, telephone|Patients randomized in the telephone arm. Their health evolution after hospital discharge will be documented via a telephone interview at J45 after hospital discharge
16151421|NCT01769261|Other|non eligibles|Patients who do not have an internet access at home. Their health evolution after hospital discharge will be documented via a telephone interview at J45. after hospital discharge.
16151422|NCT01769248|Device|Fine needle aspiration|Fine needle aspiration
16151423|NCT01769248|Device|Fine needle biopsy|FNB
16151424|NCT01769235|Drug|Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5%|Clindamycin Phosphate and Benzoyl Peroxide Gel, 1.2%/2.5% (Taro Pharmaceuticals Inc.)applied at approximately the same time once daily for 84 days (12 weeks).
16151425|NCT01769235|Drug|Acanya® Gel, 1.2%/2.5%|Acanya® (Clindamycin Phosphate and Benzoyl Peroxide) Gel, 1.2%/2.5% (Dow Pharmaceutical Sciences, Inc., marketed by Valeant Pharmaceuticals North America LLC)applied at approximately the same time once daily for 84 days (12 weeks).
16151426|NCT01769235|Drug|Vehicle of test product|Vehicle of test product (Taro Pharmaceuticals Inc.)applied at approximately the same time once daily for 84 days (12 weeks).
16151427|NCT01769222|Biological|Ipilimumab|Given intratumorally
16151428|NCT01769222|Radiation|Radiation therapy|Undergo local radiation therapy, 10 Gy x 3 fractions
16151429|NCT01769209|Drug|Bortezomib|Administered subcutaneously (SC) at 1.3 mg/m², on Days 1, 4, 8, and 11.
16151430|NCT01769209|Drug|Doxorubicin hydrochloride (HCl)|Administered intravenously (IV) over 15 min at 60mg/m², on Day 1.
16151431|NCT01769209|Drug|PEG-Asparaginase|Administered intravenously (IV) or intramuscularly (IM) 2500 U/m² (maximum 3750 U), on Days 5 and 22.
16151432|NCT01769209|Drug|Vincristine sulfate|Administered by intravenous (IV) push at 1.5 mg/m² (maximum 2 mg), on Days 1, 8, 15, and 22.
16151433|NCT01769209|Drug|Dexamethasone|Administered orally (PO) at 10 mg/m², daily on Days 1 to 14.
16151434|NCT01769209|Drug|Cytarabine|Administered intrathecally (IT) at 100 mg, on Day 1
16151435|NCT01769209|Drug|Methotrexate|Administered intrathecally (IT) at 15 mg, on Day 15.
16151436|NCT01769196|Drug|Simtuzumab|125 mg/mL single-dose vials administered subcutaneously once a week
16151437|NCT01769196|Drug|Simtuzumab placebo|Simtuzumab placebo single-dose vials administered subcutaneously once a week
16151438|NCT01769183|Drug|Squalamine Lactate ophthalmic solution 0.2%|Patients will start with Squalamine one drop twice daily to the affected eye. If at one week the neovascularization shows no sign of regression, then the dose will be doubled to four times daily with a follow up at one day and one week following the increased dose frequency, then resuming the schedule at four weeks. If neovascularization returns within the study, the dose will be doubled to four times daily. In that case, a one day and one week visit will be added after increasing the dose. Squalamine treatment will discontinue after the week 20 visit.
16151439|NCT01769170|Drug|Brincidofovir|
16151440|NCT01769170|Other|Placebo|
16151441|NCT01769157|Drug|L-carnitine|
16151442|NCT01769157|Drug|Placebo|
16151443|NCT01769144|Device|Acticoat Absorbent|wound dressing
16151444|NCT01769144|Device|BCT|wound dressing
16151445|NCT01769118|Drug|Caffeine|Caffeine will be given according to departmental protocol
16151446|NCT01769105|Device|Lipiflow|Patients receive a single Lipiflow-treatment
16151447|NCT01769105|Behavioral|Lid hygiene regime|Patients receive verbal and written instruction to perform lid hygiene twice daily
16151448|NCT01769092|Dietary Supplement|Fish Oil|The daily dose is divided; capsules are taken with meals for a period of 6 months.
16151449|NCT01769092|Other|Safflower Oil|Daily dose of safflower oil taken in divided doses as capsules and consumed with meals.
16151450|NCT01769079|Drug|Nitrate|Two arms: placebo and nitrate
16151451|NCT01769079|Drug|Placebo|
16151452|NCT01769066|Drug|Sequential Gefitinib With Pemetrexed/Platinum|
16151453|NCT01769066|Drug|Pemetrexed/Platinum|
16151454|NCT01769053|Other|Variable Ventilation|
16151455|NCT01769040|Drug|Rifaximin|550 mg two times daily for 28 days
16151456|NCT01769040|Drug|placebo|
16151457|NCT01769027|Drug|Sertraline+Antibiotic (penicillin/azithromycin)|"12 weeks treatment with a combination of Sertraline (to a maximum of 200 mg/day) and an antibiotic (benzathine penicillin G 1.200.000 U every 3 weeks or, in case of allergy, azithromycin 500 mg/week.
~Non-responder patients will be treated with IVIG (2g/kg over 5 days for 5 consecutive months)"
16151458|NCT01769027|Drug|Sertraline+placebo|12 weeks treatment with a combination of sertraline (to a maximum of 200 mg/day) and placebo
16151459|NCT01769027|Biological|IVIG|Patients who will not respond to SSRI+antibiotic (penicillin/azithromycin) will be treated with IVIG (2g/kg over 5 days for 5 consecutive months)
16151460|NCT01768988|Drug|Placebo|"Conventional treatment + placebo (during 90 days).
~Conventional treatment comprises a WHO step ladder approach and comprises in most cases:
~Paracetamol 1g/8h
~Weak opioid (tramadol at maximal doses of 400 mg/24h)
~Strong opioid in substitution of weak opioid if not efficient (e. g. morphine, oxycodone, fentanyl patch, hidromorphone), at the needed doses to control pain (VAS < 3)."
16151461|NCT01768988|Drug|Pregabalin|"Treatment during 90 days with conventional treatment + pregabalin.
~Pregabalin doses were reached until the maximal doses (300 mg/12h) depending on patient tolerability. An escalating dose scheme were desigened as follows, to avoid tolerability problems:
~Week 1 75-0-75 Week 2 75-0-150 Week 3 150-0-150 Week 4 150-0-300 Week 5 300-0-300 (until the end of study)
~Conventional treatment comprises a WHO step ladder approach and comprises in most cases:
~Paracetamol 1g/8h
~Weak opioid (tramadol at maximal doses of 400 mg/24h)
~Strong opioid in substitution of weak opioid if not efficient (e. g. morphine, oxycodone, fentanyl patch, hidromorphone), at the needed doses to control pain (VAS < 3)."
16151462|NCT01768975|Drug|OLT1177 Gel|4 mL per dose, applied 3 times per day on Days 1 - 13 with only one dose administered on Day 14, assuming TID on Day 1
16151463|NCT01768975|Other|Placebo gel|Identical dose and dosing regimen as the Investigational Drug (OLT1177 Gel)
16151464|NCT01768962|Drug|Once Daily Application of TFV RG 1% Gel - Vaginal|Vaginal application
16151465|NCT01768962|Drug|Once Daily Application of TFV RG 1% gel - Rectal|Rectal application
16151466|NCT01768962|Drug|Once Daily Application of TFV RG 1% gel - Rectal|Rectal application
16151467|NCT01768962|Drug|Once Daily Application of TFV RG 1% Gel - Vaginal|Vaginal application
16151468|NCT01768949|Device|Echocardiography|In the study RVSTAR, all the patients included will undergo an echocardiography in order to find an echocardiographic criterion predictive of the inefficacy and/or unsafeness of recruitment maneuver.
16151469|NCT01768923|Procedure|SDAI remission|SDAI remission group aims at the 2011 ACR/EILAR definition of remission (simplified disease activity score [SDAI] <3.3)
16151470|NCT01768923|Procedure|Minimal disease activity remission|Minimal disease activity group aims at minimal disease activity (DAS28<2.6) (minimal disease activity group)
16151471|NCT01768910|Other|fMRI|2 measurements using functional magnetic resonance imaging in a 3T scanner
16151472|NCT01768910|Other|bladder filling|Repetitive retrograde bladder filling via transurethral catheter with different filling volumes using body warm saline during each of the fMRI measurements.
16151473|NCT01768910|Other|bladder cooling|Retrograde bladder filling via transurethral catheter with 4-8°C saline during each of the fMRI measurements.
16151474|NCT01768910|Other|additional post-treatment fMRI scan|Should NNOAB or SCI patients receive a study independent OAB therapy by their treating physician after the 2nd fMRI scan, they will be invited for an additional third fMRI scan.
16151475|NCT01768897|Drug|CPI-613|Given IV
16151476|NCT01768897|Drug|cytarabine|Given IV
16151477|NCT01768897|Drug|mitoxantrone hydrochloride|Given IV
16151478|NCT01768897|Other|laboratory biomarker analysis|Optional correlative studies
16151479|NCT01768897|Other|pharmacological study|Correlative studies
16151480|NCT01768884|Drug|Nitric Oxide|
16151481|NCT01768884|Drug|Placebo|
16151482|NCT01768858|Drug|Adalimumab|Adalimumab administered by subcutaneous injection, via pre-filled syringe or autoinjector pen
16151483|NCT01768845|Genetic|umbilical cord blood (UCB)|Infusion will occur after preparative regimen in one or two UCB unit(s). If two products are used, they will be administered sequentially on the same day 1-6 hours apart. Tacrolimus and mycophenolate mofetil (MMF) will be used for GVHD prophylaxis.
16151484|NCT01768832|Behavioral|Treadmill|
16151485|NCT01768832|Behavioral|Tango|
16151486|NCT01768832|Behavioral|Stretching|
16151487|NCT01768819|Behavioral|Physical Activity|The intervention consisted of elderly-specific physical activity program for one year. During this period a total of 123 physical activity sessions were carried out. Each session lasted 50 minutes and included stretching, aerobic endurance exercises, resistance exercises, activities involving coordination, agility and flexibility, respiratory exercises and relaxation exercises. The sessions took place three times a week, according to American College of Sports Medicine (ACSM) recommendations. Workloads were adjusted for each subject bimonthly according to their capacity. The sessions were standardized and carried out by previously trained physical educators.
16151488|NCT01768806|Behavioral|PLAY Project Intervention for Autism|Children diagnosed with autism were recruited to the PLAY Project Intervention grant and assigned to a community standard arm (CS) or a CS plus PLAY Project arm of the study. Those in the PLAY Project arm of the study received a one time per month home visit to train caregivers in the PLAY Project methods including video feedback and caregivers also receive mid month feedback based on the video review of interaction.
16151489|NCT01768806|Behavioral|Special education pre-school|Special education preschool services included 10-12 hours per week of educational services including speech and language and occupational therapy
16151531|NCT01768572|Drug|intravenous placebo|Pharmaceutical form: solution Route of administration: intravenous
16151490|NCT01768793|Behavioral|Standard Parents As Teachers (PAT)|Participants will receive visits by Parent Educators, who will deliver the standard PAT curriculum. Participants will receive 28 total visits over the course of approximately 2 years.
16151491|NCT01768793|Behavioral|Parents As Teachers Plus (PAT+)|Participants will receive the standard PAT curriculum, plus lifestyle intervention focusing on healthy diet and exercise, through 28 home visits over the course of approximately 2 years.
16151492|NCT01768780|Device|the anticholinergic glycopyrrolate 0.1 ㎎ + 0-15 mg hyperbaric bupivacaine|"The study subjects were patients with planned orthopedic surgery on the infrapatellar area with spinal anesthesia, and 58 patients were recruited sequentially.
~A blood pressure machine, electrocardiogram, and pulse oximeter were connected to the patient in the operating room, and measurements were carried out every 5 minutes. Prior to the induction of anesthesia, the anticholinergic glycopyrrolate 0.1 ㎎ was intravenously administered after the confirmation of intravenous line opening status.
~For spinal anesthesia, the patient was arranged in the lateral recumbent position, and then the L 3-4 area was disinfected. Depending on the surgical region, height, and weight of each patient, 10-15 mg hyperbaric bupivacaine was administered through a 25 G needle."
16151493|NCT01768767|Drug|Placebo|
16151494|NCT01768767|Drug|Ketamine|
16151495|NCT01768767|Drug|Ketamine/Lithium|
16151496|NCT01768754|Behavioral|Usual and Fast Walking Speeds|Stable patients with chronic obstructive pulmonary disease will demonstrate their usual and fast walking speeds over a 30 m course, with speed calculated over the middle 10 m using optical sensors. The test will be repeated after a 5 minute rest; this procedure will then be repeated on two subsequent days, at the same time of day, within one week.
16151497|NCT01768741|Procedure|Laparoscopic liver resection|participants will be performed with laparoscopic hepatectomy using laparoscopic instruments
16151498|NCT01768741|Procedure|Open liver resection|participants will be performed with open hepatectomy using laparotomic instruments
16151499|NCT01768728|Procedure|Laparoscopic left hemihepatectomy|participants will be performed with laparoscopic left hepatectomy using laparoscopic instruments
16151500|NCT01768728|Procedure|Open left hemihepatectomy|participants will be performed with traditional open left hepatectomy using laparotomic instruments
16151501|NCT01768702|Biological|Injection of C3BS-CQR-1|Injection of the C3BS-CQR-1 using the C-Cath® injection catheter.
16151502|NCT01768702|Biological|Sham, no injection|Mimic the injection procedure trough insertion of a sham catheter. No injection actually performed
16151503|NCT01768689|Behavioral|Adherence-encouraging interventions - Group meeting|One Group meeting (at the beginning of the intervention period) for all participants, focusing on issues relevant to adherence improvement
16151504|NCT01768689|Behavioral|Adherence-encouraging interventions - Individual meetings|Individual meetings focusing on adherence issues with a multidiscilinary team
16151505|NCT01768689|Behavioral|Adherence-encouraging interventions - Monthly phone calls|Monthly phone calls to detect urgent adherence-related issues
16151506|NCT01768676|Drug|avanafil|100 mg
16151507|NCT01768676|Drug|Placebo|
16151508|NCT01768663|Drug|Lumacaftor|tablet, 200mg taken every 12 hours
16151509|NCT01768663|Drug|Ivacaftor|tablet, 250mg taken every 12 hours
16151510|NCT01768663|Drug|Ciprofloxacin|750 mg taken every 12 hours
16151511|NCT01768663|Drug|Itraconazole|200mg taken once daily
16151512|NCT01768663|Drug|Rifampin|600mg taken once daily
16151513|NCT01768650|Behavioral|Self-Management #1|Self-Management #1 will consist of eight 60-minute sessions conducted by phone over eight weeks. Sessions will include: (1) education about the role of cognitions and pain beliefs (including control) in chronic pain and adjustment; (2) instruction in how to identify negative thinking and cognitive distortions about pain; (3) instruction in thought-stopping and cognitive-restructuring techniques, including challenging negative thoughts and core beliefs about pain; (4) instruction in utilization of positive coping self-statements; (5) relaxation techniques; (6) activity pacing and scheduling; (7) coping with pain flare-ups; and (8) relapse prevention/maintenance of gains. Most sessions will include a brief relaxation exercise introduced over the phone.
16151514|NCT01768650|Behavioral|Self-Management #2|Self-Management #2 will consist of eight 60-minute sessions conducted by phone over eight weeks (1 session/week on average). The sessions will cover a variety of topics, including: (1) the definition of chronic pain, (2) the physiological processes underlying chronic pain, (3) common pain-related conditions such as sleep and mood disturbance (including posttraumatic stress disorder, due to its prevalence among Veterans), (4) the potential effects of chronic pain on activity level, (5) communication (including communication with healthcare providers), and (6) the role of social support in managing pain.
16151515|NCT01768637|Drug|Aspirin|Aspirin 81 mg by mouth daily
16151516|NCT01768637|Drug|Clopidogrel|Clopidogrel 75 mg by mouth once daily
16151517|NCT01768624|Procedure|dialysis, kidney transplant|
16151518|NCT01768598|Other|Fracture - Boys|Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years
16151519|NCT01768598|Other|Fracture - Girls|Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years
16151520|NCT01768598|Other|Non Fracture - Boys|Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years
16151521|NCT01768598|Other|Non Fracture - Girls|Annual measurements of risk taking behaviour, body composition, bone microstructure, balance, diet, and physical activity over 4 years
16151522|NCT01768585|Drug|Ivabradine|Please see description of Intervention Arm
16151523|NCT01768585|Drug|Placebo|
16151524|NCT01768572|Drug|sarilumab SAR153191 (REGN88)|Pharmaceutical form: solution Route of administration: subcutaneous
16151525|NCT01768572|Drug|tocilizumab|Pharmaceutical form: solution Route of administration: intravenous
16151526|NCT01768572|Drug|hydroxychloroquine|Dispensed according to local practice.
16151527|NCT01768572|Drug|methotrexate|Dispensed according to local practice.
16151528|NCT01768572|Drug|sulfasalazine|Dispensed according to local practice.
16151529|NCT01768572|Drug|leflunomide|Dispensed according to local practice.
16151530|NCT01768572|Drug|subcutaneous placebo|Pharmaceutical form: solution Route of administration: subcutaneous
16151658|NCT01767545|Drug|Dexamethasone implant|
16151532|NCT01768559|Drug|Lixisenatide (AVE0010)|Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection 30 to 60 minutes before breakfast or dinner.
16151533|NCT01768559|Drug|Insulin glulisine QD|Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection within 15 minutes before breakfast or dinner. The initial dose was 3-5 units and then individually titrated to obtain the SMPG value >5.6 mmol/L (100 mg/dL) and ≤7.8 mmol/L (140 mg/dL) before lunch (if administered at breakfast) or at bedtime (if administered at dinner).
16151534|NCT01768559|Drug|Insulin glulisine TID|Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection within 15 minutes before each meal. The initial dose was 3-5 units for each meal and then individually titrated to obtain the SMPG value >5.6 mmol/L (100 mg/dL) and ≤7.8 mmol/L (140 mg/dL) before the next meal or at bedtime (for injection at dinner).
16151535|NCT01768559|Drug|Insulin Glargine (Mandatory background drug)|Pharmaceutical form: Solution for injection; Route of administration: Self-administered by subcutaneous injection at breakfast or dinner. Doses were adjusted to maintain a fasting self-monitored plasma glucose (SMPG) between 4.4 to 5.6 mmol/L (80 to 100 mg/dL).
16151536|NCT01768559|Drug|Metformin (Background drug)|Pharmaceutical form: Tablet; Route of administration: Oral administration. If previously taken, Metformin to be continued at stable dose (≥1.5 g/day) throughout the study.
16151537|NCT01768546|Behavioral|Virtual Diabetes Prevention Program|Participants will view 16 Video On Demand reality based TV episodes that follow 6 adults with pre-diabetes actively participating in a DPP lifestyle intervention.
16151538|NCT01768546|Behavioral|Interactive tracking and problem solving web portal|
16151539|NCT01768520|Drug|Enteron tab. 150mg(vitis vinifera extract 150mg) : twice daily for 12 weeks|"morning : 1 tab. of active Entelon 150mg plus 1 cap. of placebo Celebrex
~evening : 1 tab. of active Entelon 150mg"
16151540|NCT01768520|Drug|Celebrex cap. (celecoxib 200mg) : once daily, for 12 weeks|"morning : 1 tab. of placebo Entelon 150mg + 1 cap. of active Celebrex
~evening : 1 tab. of placebo Entelon 150mg"
16151541|NCT01768520|Drug|Placebo|"morning : 1 tab. of placebo Entelon 150mg + 1 cap. of placebo Celebrex
~evening : 1 tab. of placebo Entelon 150mg"
16151542|NCT01768507|Dietary Supplement|Resveratrol|5 g (10 capsules) as single oral dose on day 1
16151543|NCT01768481|Drug|Atorvastatin|10 mg Atorvastatin vs placebo daily in a randomized controlled trial for one year
16151544|NCT01768481|Drug|sugar pill|placebo controlled arm receives similarly looking placebo.
16151545|NCT01768468|Drug|LAYLA tablet|1 tablet twice a day
16151546|NCT01768468|Drug|JOINS tablet|1 tablet at each time, 3 times a day
16151547|NCT01768455|Drug|Gemigliptin and Glimepiride|Gemigliptin 50mg (qd) on Day1~Day6 and Gemigliptin 50mg (qd) and Glimepiride 4mg (qd) on Day7
16151548|NCT01768455|Drug|Glimepiride|Glimepiride 4mg (qd) on Day1
16151549|NCT01768429|Behavioral|Fatty fish|
16151550|NCT01768429|Behavioral|Lean Fish|
16151551|NCT01768429|Behavioral|Alpha-linolenic acid|
16151552|NCT01768429|Behavioral|Control|
16151553|NCT01768390|Other|toothpaste containing 5,000 ppm fluoride|1 cm tootpaste twice daily during 2 minutes
16151554|NCT01768390|Other|1450 GCP|Twice gaily toothbrushing with normal adult toothpaste containing 1450 ppm F representing good clinical practice
16151555|NCT01768377|Drug|Nerve block with Lidocain|Lidocain 2% topical injection, 0.5 - 1 cc Lidocain 4% topical injection, 3 cc Lidocain 10% topical spray , total dose 50 mg
16151556|NCT01768377|Drug|Fentanyl|Fentanyl 2 microgram/Kg BW IV
16151557|NCT01768377|Drug|Midazolam|Midazolam 0.05 mg/kg BW IV infusion
16151558|NCT01768364|Drug|Trimetoprim-Sulfa (Bactrim)|
16151559|NCT01768364|Other|No antibiotics|
16151560|NCT01768351|Drug|Paricalcitol|Zemplar cp 1 mcg/day per os
16151561|NCT01768351|Drug|Calcitriol|Rocaltrol cp 0,5 mcg every other day per os
16151562|NCT01768338|Drug|Ofatumumab combined with SB-485232|Ofatumumab with escalating doses of SB-485232
16151563|NCT01768325|Device|EUS-TCB needle (QuickCore) standard of care|"The number of needle passes requiring to acquire adequate specimen were tallied.
~Length of core tissue obtained
~Diagnostic contribution of immunohistochemical staining
~Rates of complications"
16151564|NCT01768325|Device|EUS-Guided biopsy needle (ProCore)|"The number of needle passes requiring to acquire adequate specimen were tallied.
~Length of core tissue obtained
~Diagnostic contribution of immunohistochemical staining
~Rates of complications"
16151565|NCT01768312|Drug|Cyclosporine ophthalmic solution|1 drop twice/day for 12 weeks to both eyes
16151566|NCT01768299|Drug|Mifepristone|200 mg oral Mifepristone 24 hours before 400 mcg buccal misoprostol
16151567|NCT01768299|Drug|Misoprostol|200 mg oral Mifepristone simultaneously 400 mcg buccal misoprostol
16151568|NCT01768286|Drug|LDV/SOF|Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet administered orally once daily
16151569|NCT01768286|Drug|RBV|Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16151570|NCT01768273|Drug|Midazolam|
16151571|NCT01768273|Drug|PA-824|
16151572|NCT01768260|Device|Enhanced external counterpulsation|EECP is performed for 1 hours every day, for a total of 36 hours.
16151573|NCT01768260|Drug|Aspirin|Standard drug therapy
16151574|NCT01768247|Drug|HCG (human chorionic gonadotropin)|150 international units (IU) of HCG for seven days subcutaneously concomitantly with estrogens in preparation endometrium cycles fro frozen embryos replacement
16151575|NCT01768234|Other|Supplemental water|1-2L of supplemental water provided between pre-test and post-test
16151576|NCT01768221|Behavioral|Caregiver Intervention|"Participants will speak with a chaplain for three brief, 45 minute to one hour, sessions.
~The sessions will focus on topics of relationship life review, unresolved conflicts and issues of forgiveness, and future goals, lessons learned and legacy.
~In the week following the third session, the chaplain will call participants for a brief check in. This call will include no new intervention content, rather it provides an opportunity for participants to mention any additional thoughts or concerns they want to discuss with the chaplain interventionist."
16151577|NCT01768208|Drug|Saxagliptin|
16151659|NCT01767545|Drug|Bevacizumab|
16151660|NCT01767532|Drug|Cephalexin 125 mg/5ml|Reference product 20 ml
16151578|NCT01768195|Drug|Entecavir prophylaxis|"Entecavir 0.5mg daily from day 1 of immunochemotherapy and/or chemotherapy to 12 months after completing immunochemotherapy and/or chemotherapy.
~In patients with low load of hepatitis B virus DNA(≤2000 IU/ml), rituximab will be administrated at the beginning of entecavir prophylaxis. And in patients with high load of hepatitis B virus DNA(>2000 IU/ml), rituximab will be administrated when hepatitis B virus DNA decreased to the level of 2000 IU/ml after entecavir prophylaxis."
16151579|NCT01768182|Dietary Supplement|Folinic Acid|Participants were randomly assigned to a 4-week treatment with either folinic acid (n=15) or placebo (n=15). The study supplementation regimens consisted of the capsules containing 5 mg of folinic acid or placebo. Participants were provided with 1 bottle, which contained 30 capsules. Subjects were instructed to take 1 capsule daily, in the morning
16151580|NCT01768182|Other|Placebo|The study supplementation regimens consisted of the capsules containing 5 mg of folinic acid or placebo. Participants were provided with 1 bottle, which contained 30 capsules. Subjects were instructed to take 1 capsule daily, in the morning
16151581|NCT01768169|Dietary Supplement|fish oil capsule|500 mg of natural fish oil, made up of 30% omega-3 PUFA (EPA:DHA = 3:2)
16151582|NCT01768156|Other|Experimental arm|"Serum samples are collected:
~at time of diagnosis of recurrence (before 1st chemotherapy)
~during each cycle of chemotherapy
~after the end of chemotherapy
~every 3 month until treatment failure (3-6 samples)
~stop at the progression or after 18 months post chemotherapy"
16151583|NCT01768143|Behavioral|unexperienced endoscopy nurses|
16151584|NCT01768143|Behavioral|Experienced endoscopy nurses|
16151585|NCT01768117|Biological|rLP2086|0.5 ml intramuscular injection of 120 microgram bivalent rLP2085 administered at 0, 2 and 6 months
16151586|NCT01768104|Procedure|ESTD|"A 2-cm longitudinal mucosal incision was made, approximately 5cm proximal to the submucosal tumor (SMTs).
~Submucosal dissection was done, creating a submucosal tunnel until the tumor was visible.
~Dissection was done along the margin of the tumor.
~After the tumor had been removed, the potential bleeding area in the tunnel was coagulated.
~Endoclips were used to close the entry of the submucosal tunnel.
~(Gong W et al. ESTD for upper gastrointestinal submucosal tumors… Endoscopy 2012; 44: 231-235)"
16151587|NCT01768104|Procedure|VATS|"General anesthesia with double lumen intubation.
~Three to four cameras or working ports are placed over the chest wall.
~After the lesion is visualized by thoracoscopy, the mediastinal pleura over the tumor is incised longitudinally by an endoscopic hook electrocauterizer.
~The mass is exposed after the overlying muscle is split longitudinally.
~The retracting suture is placed over the mass and then meticulously dissect the plane between the mass and the submucosal layer. The integrity of the mucosa must be checked.
~The muscle layer is re-approximated and a chest tube is place through one of the ports.
~(Luh et al. World Journal of Surgical Oncology 2012, 10:52)"
16151588|NCT01768091|Procedure|POEM|"Entry to submucosal space. After submucosal injection, a 2-cm longitudinal mucosal incision is made at approximately 13 cm proximal to the gastroesophageal junction (GEJ).
~Submucosal tunnelling. A long submucosal tunnel is created to 3 cm distal to the GEJ.
~Endoscopic myotomy is begun at 3 cm distal to the mucosal entry point, and is carried out in a proximal to distal direction to a total length of 10 cm.
~Long endoscopic myotomy of inner circular muscle bundles is done, leaving the outer longitudinal muscle layer intact. The expected end point of myotomy is 2 cm distal to the GEJ.
~Closure of mucosal entry: the mucosal incision is closed using hemostatic clips.
~(Inoue H et al. POEM for esophageal achalasia… Endoscopy 2010; 42: 265-271)"
16151589|NCT01768091|Procedure|Pneumatic dilation|"A Rigiflex balloon (30 mm) was positioned at the esophagogastric junction and dilated at a pressure of 5 PSI for 1 minute, followed by 8 PSI for 1 minute.
~(N Engl J Med 2011;364:1807-16.)"
16151590|NCT01768078|Procedure|Intravitreal injection of Betamethasone + antibiotics|
16151591|NCT01768078|Procedure|Intravitreal injection of antibiotics|
16151592|NCT01768065|Device|Nasal Expiratory Positive Airway Pressure Device|assigned to Nasal Expiratory Positive Airway Pressure arm
16151593|NCT01768065|Device|placebo sham|
16151594|NCT01768052|Device|functional Near Infrared Spectroscopy|fNIRS monitoring during rTMS treatment sessions.
16151595|NCT01768039|Drug|Vitamin D|
16151596|NCT01768039|Drug|Placebo|
16151597|NCT01768013|Drug|LEO 90105|Once daily for four weeks
16151598|NCT01768000|Behavioral|Family Cognitive Adaptation Training|Family CAT is a 4 month manualised intervention designed to be administered by families independent of clinician support. A self scoring checklist is provided to assess and tailor Family CAT to the individual, along with descriptions of strategies for bathing, dressing, dental hygiene, make-up, toileting, housekeeping/care of living quarters, laundry, grocery shopping, transportation, management of money and consumables, medication management, social skills, communication and telephone use, leisure skills, work skills, and orientation. Family members will watch the DVD to gain insight into how the strategies can be implemented in real world settings. Having identified the areas of need, family members will administer the interventions and evaluate their effectiveness for the individual.
16151599|NCT01767987|Drug|Ranolazine|Drug: Ranolazine 1000 mg Oral dose twice per day for 3 days leading up to PCI
16151600|NCT01767987|Drug|Placebo|Drug: Placebo Oral dose twice per day for 3 days leading up to PCI
16151601|NCT01767961|Procedure|diagnostic imaging|Undergo MBS
16151602|NCT01767961|Other|questionnaire administration|Correlative studies
16151603|NCT01767961|Procedure|quality-of-life assessment|Correlative studies
16151604|NCT01767948|Drug|PCI-32765|PCI-32765 140 mg will be administered as a single dose, orally, on Day 1.
16151605|NCT01767935|Procedure|cryosurgery|Undergo cryosurgery
16151606|NCT01767935|Radiation|radiation therapy|Undergo radiation therapy
16151607|NCT01767935|Procedure|quality-of-life assessment|Ancillary studies
16151608|NCT01767922|Dietary Supplement|Extramel 10 mg - 140 UI SOD|"Subjects took one capsule of Extramel® 140 IU, or its corresponding placebo, daily over 12 weeks.
~Each volunteer was seen for the 3 visits:
~visit V1, so-called inclusion visit (D0),
~visit V2 at 28 days, tolerance of +/- 3 days, (D28) and
~visit V3 at 84 days, tolerance of +/- 3 days, (D84)."
16151609|NCT01767922|Dietary Supplement|Placebo - Excipient only|
16151610|NCT01767909|Drug|Insulin (Humulin® R U-100)|20 IU bid taken twice daily (approximately 30 minutes after breakfast and dinner) for a total of 40 IU daily, which will be administered intranasally. The device used to administer insulin releases a metered dose into a chamber covering the participant's nose. The insulin is then inhaled by breathing evenly over a specified period.
16151611|NCT01767909|Drug|Placebo|Placebo taken twice daily (approximately 30 minutes after breakfast and dinner), which will be administered intranasally. The device used to administer placebo releases a metered dose into a chamber covering the participant's nose. The placebo is then inhaled by breathing evenly over a specified period.
16151612|NCT01767896|Biological|ASP7374|subcutaneous (sc)
16151613|NCT01767896|Biological|approved egg-derived TIV|subcutaneous (sc)
16151614|NCT01767883|Other|Facilitated Clinical Decision Support|"The primary care practices in this arm will receive:
~CKD decision support algorithms added to their Clinical Decision Support
~System Academic detailing concerning the rationale for the algorithms
~On-going mentoring and practice facilitation
~Audit and feedback during quarterly reviews of practice data with the practice facilitator by videoconference."
16151615|NCT01767883|Other|Clinical Decision Support Only|"CKD decision support algorithms added to their Clinical Decision Support
~System Academic detailing concerning the rationale for the algorithms"
16151616|NCT01767870|Procedure|FIT-sigmoidoscopy|Advanced colorectal adenoma detection by fecal immunochemical test with sigmoidoscopy
16151617|NCT01767870|Procedure|Colonoscopy|Advanced colorectal adenoma detection by colonoscopy
16151618|NCT01767857|Drug|Xilonix|Xilonix is a True Human Monoclonal Antibody targeting Interleukin 1 alpha, and is administered intravenously every 2 weeks with best supportive care until clinical or radiographic progression.
16151619|NCT01767857|Drug|Placebo|Placebo plus best supportive care will be administered intravenously every 2 weeks until clinical or radiographic progression.
16151620|NCT01767844|Dietary Supplement|Creatine|Creatine, often found in meat and fish, make up an essential part of the systems that provide energy to the muscles for movement and exercise.
16151621|NCT01767844|Dietary Supplement|Placebo|
16151622|NCT01767831|Behavioral|iBOLUSED|The intervention will involve daily diary data upload and daily simulation-based feedback based on the collected diary data. Throughout the educational intervention, participants will record diary data every day through the use of a diary component in the internet-based system. Diary entries include data on meals, physical activity, history of the insulin basal rate and insulin boluses given that day, self-reported stress level, hypo- and hyperglycemic fear levels, and, if applicable, menstrual cycle and any physical illness. Participants will also upload data from the CGM via the Dexcom DM3 software or the Dexcom Studio Software.
16151623|NCT01767805|Procedure|Standard incubator|
16151624|NCT01767805|Procedure|Mini incubator|
16151625|NCT01767805|Procedure|5% oxygen|
16151626|NCT01767805|Procedure|20% oxygen|
16151627|NCT01767792|Drug|Bevacizumab|"Treatment will be administered on an outpatient basis. Bevacizumab is administered by IV infusion at a dose of 10 mg/kg every 2 weeks for 24 weeks (induction therapy, see Schema). One cycle lasts 28 days and includes two infusions of bevacizumab. Clinical response will be assessed by audiology and MRI at weeks 12 and 24. Subjects with hearing decline at weeks 12 and 24 will be taken off of protocol. After week 24, patients with a clinical response or stable disease (together comprising clinical benefit) will transition to maintenance therapy with bevacizumab.
~During the maintenance phase, subjects will be treated with open-label bevacizumab 5 mg/kg every 3 weeks for up to 72 weeks. Subjects will be followed with audiology and MRI scans every 12 weeks. The total time of the study will be 96 weeks (24 weeks induction + 72 weeks maintenance)."
16151628|NCT01767766|Drug|TGR-1202|TGR-1202 Daily Oral Dose
16151629|NCT01767753|Device|Sensimed Triggerfish|Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
16151630|NCT01767740|Device|ULTRABRAID PLUS SUTURE|Rotator Cuff Repair with ULTRABRAID PLUS SUTURE
16151631|NCT01767740|Device|ULTRABRAID SUTURE|Rotator Cuff Repair with ULTRABRAID SUTURE
16151632|NCT01767727|Procedure|Soft tissue coverage|The dorsal homodigital island flaps are used for soft tissue coverage of multiple finger defects
16151633|NCT01767714|Drug|Granulocyte-colony stimulating factor (G-CSF)|10 µg/kg/day G-CSF, administered by subcutaneous (SC) injection
16151634|NCT01767714|Drug|Plerixafor|0.24 mg/kg/day subcutaneous injection
16151635|NCT01767714|Drug|Placebo|0.24mg/kg/day placebo (0.9% Sodium Chloride) administered by subcutaneous injection
16151636|NCT01767701|Drug|Raltegravir|400mg twice daily for 3 months
16151637|NCT01767688|Drug|MK-3102|Single dose of 25 mg of MK-3102 (1 x 25 mg capsule) administered orally on Day 1.
16151638|NCT01767675|Procedure|Secondary Cytoreductive Surgery|
16151639|NCT01767675|Drug|Carboplatin Hyperthermic Intraperitoneal Chemotherapy (HIPEC)|
16151640|NCT01767675|Drug|platinum-based systemic chemotherapy postoperatively|5 cycles
16151641|NCT01767675|Drug|platinum-based systemic chemotherapy postoperatively|6 cycles
16151642|NCT01767662|Procedure|manipulation|home programme
16151643|NCT01767662|Procedure|No intervention|observation
16151644|NCT01767649|Other|Caesarean|Collection of tissues and blood
16151645|NCT01767649|Other|Vaginal delivery|Collection of tissues and blood
16151646|NCT01767636|Drug|Pazopanib Hydrochloride|Given PO
16151647|NCT01767623|Drug|Vemurafenib|Vemurafenib orally BID 960 or 720 mg.
16151648|NCT01767610|Drug|micronized fenofibrate 160mg|
16151649|NCT01767610|Drug|pitavastatin Ca 2mg|
16151650|NCT01767610|Drug|micronized fenofibrate 160mg plus pitavastatin Ca 2mg|
16151651|NCT01767597|Other|ELISA testing|Enzyme-linked immuno-assay (ELISA) will be used to determine hepatitis B surface antigen (HBsAg) and anti-HBsAg antibody (anti-HBs Ab) status. Results will be given after test results are available (8-10 days).
16151652|NCT01767597|Other|Rapid testing|A rapid test will be performed to determine the subjects' hepatitis B surface antigen (HBsAg, using VIKIA®) and anti-HBs antibody status (anti-HBs Ab, using Quick ProfileTM). Results will be given the same day.
16151653|NCT01767584|Drug|Cephalexin 1g tablets|Reference product
16151654|NCT01767584|Drug|Cephalexin 1g tablets|Test product
16151655|NCT01767571|Drug|Cephalexin 125 mg/5ml|Reference product 20 ml
16151656|NCT01767571|Drug|Cephalexin 250mg/5ml|Test product 10 ml
16151657|NCT01767558|Other|Ablation / MRI|"All subjects will undergo a standard of care ablation procedure for paroxysmal AF with the CE-Marked PVAC GOLD catheter.
~MRIs will be performed on all subjects at Enrollment and Pre-Discharge (Post Ablation). Subjects with a positive MRI (cerebral lesion) at Pre-Discharge will undergo another MRI at the 1 month follow-up visit."
16151661|NCT01767532|Drug|Cephalexin 125 mg/5ml|Test product 20 ml
16151662|NCT01767519|Biological|BOTOX®|BOTOX 100U injected at Day 1 (BOTOX/solifenacin placebo arm). After a minimum of 12 weeks, all patients could request/qualify for a BOTOX injection.
16151663|NCT01767519|Drug|solifenacin|Beginning on Day 1, one 5 mg solifenicin capsule, with optional dose increase to 10 mg at Week 6, (both overencapsulated for blinding purposes) taken orally once daily for up to 24 weeks.
16151664|NCT01767519|Drug|Botox placebo (normal saline)|Botox placebo (normal saline) intradetrusor injection at Day 1.
16151665|NCT01767519|Drug|solifenacin placebo|Beginning on Day 1, one capsule taken orally once daily for up to 24 weeks.
16151666|NCT01767506|Other|Surveillance and treatment with azithromycin of newcomer and traveler families|The intervention is a surveillance for newcomers and travelers in communities, and provision of azithromycin to them at the time of arrival, in advance of scheduled mass drug administration
16151667|NCT01767506|Other|Usual care|Scheduled mass drug administration (MDA) of azithromycin if trachoma infection level is greater than 1% or TF is 5% or more. Communities will have MDA stopped if infection is 1% or less, or TF is less than 5%. MDA will be reinstated if infection re-emerges to 6% or more.
16151668|NCT01767493|Drug|[18F]Florbetapir PET imaging|[18F]Florbetapir and PET imaging
16151669|NCT01767480|Device|RT|The Bi-Manu-Track enables the symmetrical practice of 2 movement patterns in conjunction with computer games: forearm pronation-supination and wrist flexion-extension. Each movement has three computer-controlled modes: (1) passive-passive, with both arms being moved by the machine with speed and range of motion individually adjustable; (2) active-passive, with the nonaffected arm driving the affected arm in a mirror-like fashion; and (3) active-active, with both arms actively moving against resistance. The speed of movement, the amount of resistance, and the range of movement can be adjusted individually. The device has a mechanical breaking of the movement when the torques exceeded 4 Nm, emergency breaks in the reach of the patients, skin friendly materials, and minimal risk for contusions.
16151670|NCT01767480|Behavioral|Conventional rehabilitation (CR)|CR will focus on neurodevelopmental techniques with emphasis on functional tasks when possible. The functional training will be designed based on patients' motor capacity and include gross motor and fine motor dexterity training, and transitive and intransitive training. Stretching of the more affected limb, passive and active range of movements, and normalizing muscle tone by applying reflex inhibition patterns, inhibiting abnormal patterns, weight bearing with the affected limb will be applied to assist in functional task practice.
16151671|NCT01767467|Biological|Herpes zoster vaccine (GSK 1437173A)|2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm. Dose 1 administered at Day 0. Dose 2 administered 1-2 months post Dose 1.
16151672|NCT01767467|Drug|Placebo|2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm. Dose 1 administered at Day 0. Dose 2 administered 1-2 months post Dose 1.
16151673|NCT01767454|Drug|Dabrafenib|Dabrafenib 100 mg or 150 mg BID orally will be administered. Capsules with unit dose strengths of 50 mg or 75 mg
16151674|NCT01767454|Drug|Trametinib|Trametinib 1 mg or 2 mg once daily will be administered. Tablets with unit dose strengths of 0.5 mg or 2 mg
16151675|NCT01767454|Drug|Ipilimumab|Ipilimumab 3 mg/kg intravenously over 90 minutes Q3W for a total of 4 doses will be administered. Supplied as Vials of 50 mg/10 mL (5 mg/mL) and 200 mg/40 mL (5 mg/mL)
16151676|NCT01767441|Procedure|Roux-en-Y-gastric bypass|Gastric bypass consisted of creation of a 15-20 ml gastric pouch, a 150 cm Roux limb, and a 50 cm biliopancreatic limb
16151677|NCT01767441|Procedure|laparoscopic adjustable gastric banding|Gastric banding functions by limiting food intake after the placement of an inflatable tube around the stomach just below the gastroesophageal junction, which allows for adjustment of the size of the outlet via the addition or removal of saline through a subcutaneous port.
16151678|NCT01767441|Procedure|laparoscopic sleeve gastrectomy|Sleeve gastrectomy involved a gastric reduction of 75 to 80% by resecting the stomach alongside a 30-French endoscope beginning 3 cm from pylorus and ending at the angle of His
16151679|NCT01767441|Other|diet treatment|Hypocaloric diet providing a 1000 Kcal/d deficit from total energy expenditure assessed by indirect calorimetry and physical activity determination
16151680|NCT01767428|Drug|Paracetamol|500 mg immediate release paracetamol formulations
16151681|NCT01767415|Drug|Indigo carmine|During resection, a small quantity of a special dye called indigo carmine will be infused at the margins of the tumor using computer-guided stereotactic navigation equipment. This dye will be visible during the tumor resection and it can potentially serve as an additional marker of the tumor margins. A post-operative MRI scan -which is part of the standard care- will accurately measure the extent of tumor resection.
16151682|NCT01767402|Biological|PhtD vaccine with/without adjuvant|Two doses of different formulations of PhtD vaccine administered intramuscularly in the deltoid region of the right arm at month 0 and month 2.
16151683|NCT01767402|Biological|Pneumovax 23TM|One dose of Pneumovax 23TM vaccine administered intramuscularly in the deltoid region of the right arm at month 0.
16151684|NCT01767402|Biological|NaCl|One dose administered intramuscularly in the deltoid region of the right arm at month 2.
16151685|NCT01767389|Other|The GLP-1 receptor agonist users|The GLP-1 receptor agonist users are classified based on the receipt of a GLP-1 receptor agonist at the index date. GLP-1 receptor agonists included in this study are exenatide and liraglutide
16151686|NCT01767389|Other|DPP-4 inhibitor users|DPP-4 inhibitor users are classified based on the receipt of a DPP-4 inhibitor prescription at the index date. The DPP-4 inhibitors included in this study are sitagliptin, saxagliptin, linagliptin, combination of sitagliptin and metformin (Janumet), and combination of sitagliptin and simvastatin (Juvisync)
16151687|NCT01767389|Other|Other ADA users|Classes of ADA's other than GLP-1 receptor agonists and DPP-4 inhibitors will be included in the 'other ADA' exposure group
16151688|NCT01767376|Biological|Meningococcal vaccine GSK134612|One dose administered intramuscularly (IM) in the deltoid muscle of the arm.
16151689|NCT01767376|Biological|Boostrix®|One dose administered intramuscularly (IM) in the deltoid of the right arm (in Co-ad Group) and left arm (in TdapACWY and ACWYTdap Groups).
16151690|NCT01767363|Other|5-alpha reductase inhibitors|Use of 5-alpha reductase inhibitors over the course of the study period.
16151691|NCT01767363|Other|Alpha-blockers|Use of alpha-blockers over the study period.
16151746|NCT01767012|Device|Polylens EC-HY10-PAL (coated)|hydrophobic acrylic IOL with modified surface properties (Heparin-coating)
16151692|NCT01767350|Procedure|Blood withdrawal for DNA|"Single withdrawal of 8 ml whole blood for DNA analysis, during a standard blood collection as part of standard clinical follow up."
16151693|NCT01767337|Device|FLUGEN 101.2 device|
16151694|NCT01767324|Device|Injection to deltoid|Deliver 0.5 milliliters of saline intradermally
16151695|NCT01767324|Device|Injection to forearm|Deliver 0.5 milliliters of saline intradermally
16151696|NCT01767324|Device|Injection to thigh|Deliver 0.5 milliliters of saline intradermally
16151697|NCT01767311|Drug|Lecanemab 2.5 mg/kg|2.5 mg/kg biweekly (once every 2 weeks) administered as a 60 minute i.v. infusion
16151698|NCT01767311|Drug|Lecanemab 5.0 mg/kg|5.0 mg/kg biweekly (once every 2 weeks) administered as a 60 minute i.v. infusion
16151699|NCT01767311|Drug|Lecanemab 10 mg/kg|10 mg/kg biweekly (once every 2 weeks) administered as a 60 minute i.v. infusion.
16151700|NCT01767311|Drug|Lecanemab 5.0 mg/kg|5.0 mg/kg monthly (once every 4 weeks) administered as a 60 minute i.v. infusion. All participants will receive biweekly infusions, participants will have placebo infusion alternating with BAN2401
16151701|NCT01767311|Drug|Lecanemab 10 mg/kg|10 mg/kg monthly (once every 4 weeks) administered as a 60 minute i.v. infusion. All participants will receive biweekly infusions, participants will have placebo infusion alternating with BAN2401
16151702|NCT01767311|Drug|Placebo|biweekly (once every 2 weeks) administered as a 60 minute i.v. infusion
16151703|NCT01767298|Drug|Valsartan/Hydrochlorothiazide|Co-administration or fixed dose combination
16151704|NCT01767298|Drug|Valsartan|Valsartan alone
16151705|NCT01767298|Drug|Hydrochlorothiazide|Hydrochlorothiazide alone
16151706|NCT01767285|Drug|Etonogestrel implant|This will be placed in subjects in both arms. Those in Arm 1 will receive the implant in the hospital postpartum. Those in Arm 2 will receive the implant at the 6 week postpartum visit.
16151707|NCT01767272|Drug|fexofenadine|fexofenadine brand name
16151708|NCT01767259|Drug|Valsartan/Hydrochlorothiazide|Co-administration or fixed dose combination
16151709|NCT01767259|Drug|Valsartan|Valsartan alone
16151710|NCT01767259|Drug|Hydrochlorothiazide|Hydrochlorothiazide alone
16151711|NCT01767246|Other|PFS Algorithm treatment|Physical Therapy treatment for Patellofemoral Syndrome based upon a treatment algorithm. that addresses patients: fear avoidance beliefs, flexibility, body mechanics, and strength. The exercises and treatments are individualized to each patients with the goal of have low fear avoidance beliefs, flexibility, body mechanics, and strength.
16151712|NCT01767246|Other|Multimodal treatment|Physical Therapy treatment for Patellofemoral Syndrome based upon the Multimodal treatment (Lowry, 2008).
16151713|NCT01767233|Procedure|ERCP and pancreatic stenting|
16151714|NCT01767220|Procedure|Strategy 1 - endocardial ablation|VT substrate mapping and VT ablation are done only from endocardial. Therefore the catheters are introduced through the femoral veins/arteries. For mapping and ablation a 3,5 mm irrigated tip catheter (Navistar Thermocool, Biosense Webster, Diamond Bar, CA, USA) will be used.
16151715|NCT01767220|Procedure|Strategy 2 - endocardial and epicardial ablation|VT substrate mapping and VT ablation are done from endocardial and epicardial. Therefore the catheters are introduced through the femoral veins/arteries and into the pericardial space via a pericardial puncture. After endocardial and epicardial mapping, ablation is done from endocardial. In case of an ineffective endocardial ablation and an epicardial substrate an epicardial ablation is done. For mapping and ablation from endo- and epicardial a 3,5 mm irrigated tip catheter (Navistar Thermocool, Biosense Webster, Diamond Bar, CA, USA) will be used.
16151716|NCT01767207|Other|mental disorders|mental disorders
16151717|NCT01767207|Behavioral|screening for mental disorders|screening for mental disorders
16151718|NCT01767194|Biological|Dinutuximab|Given IV
16151719|NCT01767194|Drug|Irinotecan Hydrochloride|Given IV
16151720|NCT01767194|Other|Laboratory Biomarker Analysis|Optional correlative studies
16151721|NCT01767194|Biological|Sargramostim|Given SC or IV
16151722|NCT01767194|Drug|Temozolomide|Given PO
16151723|NCT01767194|Drug|Temsirolimus|Given IV
16151724|NCT01767181|Other|Intensive light therapy|Light therapy will be applied by a Lumie Brazil fluorescent tube light box (10.000 lux) during the night shifts for 12 consecutive weeks
16151725|NCT01767181|Other|Exercise|Physical exercise will be performed in a supervised environment on the days of the night shifts, either before the start of the shift (defined as a time period beginning no earlier than 2 hours before the start of the shift) or after the end of the night shift (defined as a time period ending no longer than 2 hours after the end of the night shift)
16151726|NCT01767168|Other|comprehensive preoperative testing for risk factors of persistent postoperative pain|nociceptive reflex threshold, pain threshold, CPM-effect of hot water bath, pain sensitivity questionnaire, STAI, BDI, fear of surgical consequences
16151727|NCT01767155|Drug|AEZS-108 / zoptarelin doxorubicin|267 mg/m^2 by 2-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles for a maximum of 9 cycles
16151728|NCT01767155|Drug|doxorubicin|60 mg/m^2 by intravenous bolus injection or 1-hour intravenous infusion, on Day 1 of 21-day (3-week) cycles
16151729|NCT01767142|Device|The Zeltiq System with Modified Belt Applicator|Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
16151730|NCT01767129|Drug|AVP-923-45|One capsule twice daily for 14 days
16151731|NCT01767129|Drug|Placebo|One capsule twice daily for 14 days
16151732|NCT01767116|Drug|ABT-450/r/ABT-267, ABT-333|Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
16151733|NCT01767116|Drug|Ribavirin|Capsule
16151734|NCT01767116|Drug|Placebo for ribavirin|Capsule
16151735|NCT01767103|Drug|Ferriprox®|
16151736|NCT01767090|Drug|ASP1707|Oral
16151737|NCT01767090|Drug|Placebo|Oral
16151738|NCT01767090|Drug|Leuprorelin acetate|subcutaneous
16151739|NCT01767077|Dietary Supplement|Butter oil|Daily intake of 40 g butter oil
16151740|NCT01767077|Dietary Supplement|Cream|Daily intake of 100 g cream (40%)
16151741|NCT01767064|Other|Posted commitment letter|
16151742|NCT01767038|Procedure|OCT Spectralis|
16151743|NCT01767038|Procedure|microperimetry|
16151744|NCT01767025|Drug|Oxytocin|
16151745|NCT01767025|Drug|Sea water|
16151747|NCT01767012|Device|Polylens EC-Y10-PAL (uncoated)|
16151748|NCT01766960|Other|High fat meal|A high fat breakfast will be administered to induce gall bladder emptying.
16151749|NCT01766960|Drug|Morphine|Five milligrams of intravenous morphine will be administered.
16151750|NCT01766947|Device|Sensimed Triggerfish|Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
16151751|NCT01766921|Biological|Adjuvanted H5N1 pandemic influenza vaccine|Comparison of two doses of aH5N1c vaccine
16151752|NCT01766908|Other|Clamp cord 20, 40 or 60 seconds following vaginal or cesarean delivery|None to add
16151753|NCT01766895|Other|blood sampling|blood sampling of viral hepatitis to determined seroprevalence in uremic patients
16151754|NCT01766882|Behavioral|Lower sodium intervention|"1. Lower sodium intervention:
~Dietary sodium restriction of ≤2.0 g/day or ≤85 mmol/day (approximately >180-200mmol/day in the average American diet). Sodium restriction will be implemented using intensive dietary counseling performed weekly by a registered study dietitian using the motivational interviewing technique.
~Lower dialysate sodium at 137 mmol/L, if perchance a different concentration of dialysate is used for the enrolled individual, although this is unlikely in both the UM associated units, where for some time now, dialysate concentration of 137 mmol/L is currently being used as standard practice. Investigators will ensure that this sodium concentration is indeed used for all study participants."
16151755|NCT01766882|Other|Progressive Challenge to Post Dialysis Weight|The existing target post-HD weight will be progressively challenged by removing additional fluid in small increments, unless clinical evidence of volume depletion or hypotension precludes this challenge in the intervention arm. To avoid the occurrence of intradialytic hypotension, the ultrafiltration rate shall not exceed15 ml/kg/hour and post dialysis weight will not be reduced by more than 0.5 kg per dialysis session. In some patients, this may warrant prolongation of the treatment time to achieve lowering of target post dialysis weight, and this process of target weight reduction may need to continue up to and through the interim assessment phase (6-8 weeks).
16151756|NCT01766856|Other|Eustachian tube function testing|Eustachian tube function testing will consist of some or all of the following tests: Inflation/Deflation test, Forced Response test, Compliance test,Valsalva, Toynbee and Sniffing
16151757|NCT01766843|Drug|Seretide Diskus and charcoal|2 inhalations as a single dose
16151758|NCT01766843|Drug|Seretide Diskus|2 inhalations as a single dose
16151759|NCT01766843|Drug|SF Easyhaler and charcoal|2 inhalations as a single dose
16151760|NCT01766843|Drug|SF Easyhaler|2 inhalations as a single dose
16151761|NCT01766830|Device|rk28 ICT|rk28 ICT is an immunochromatographic assay intended for qualitative detection of IgG antibodies directed towards VL in human serum, plasma or whole blood. It is manufactured by EASE-Medtrend (Shanghai, China)
16151762|NCT01766830|Device|IT LEISH (rK39)|IT LEISH is an immuno-chromatographic test, using the recombinant antigen K39, to detect the presence of antibodies against Leishmania spp. It is manufactured by BioRad laboratories, USA.
16151763|NCT01766830|Device|Immunochromatographic HAT test|This is a lateral flow immunochromatographic test manufactured by Standard Diagnostics (Korea) in collaboration with FIND.
16151764|NCT01766830|Device|HAT Serostrip|The HAT Serostrip is an immunochromatographic assay developed by Coris BioConcept, France, which is designed for remote field use in individual HAT suspects.
16151765|NCT01766830|Device|Card Agglutination Trypanosoma Test (CATT)-10|The Card Agglutination Trypanosoma test (CATT) has been used for many years at large scale for mass screening of mostly asymptomatic individuals (CATT-R250). Unfortunately, its operating characteristics have only been evaluated in the context of patients with persistent fever. Although it is not strictly an RDT, the CATT is rather easily performed in remote settings, in particular since a new and more robust format (CATT-D10) allows to test a lower number of patients in peripheral health facilities. It is manufactured by the Institute of Tropical Medicine of Antwerp, Belgium.
16151766|NCT01766830|Device|Typhidot M|The Typhidot M test is a dot enzyme immunoassay that detects IgM and IgG directed against Salmonella typhi. It is manufactured by Reszon Diagnostics International, Malaysia
16151767|NCT01766830|Device|S. typhi IgM/IgG|The Salmonella typhi IgG/IgM Rapid Test is an immunochromatographic assay for the qualitative differential detection of IgG and IgM antibodies to Salmonella typhi in human serum, plasma or whole blood. It is manufactured by Standard Diagnostics (Korea)
16151768|NCT01766830|Device|Test-it Typhoid IgM|Test-it Typhoid IgM lateral flow assay is a one-step immunochromatographic assay which uses a lipopolysaccharide (LPS) antigen derived from salmonella typhi for the detection of specific IgM antibodies. It is manufactured by Life Assay, South Africa.
16151769|NCT01766830|Device|Test-it Leptospirosis IgM|The Test-it™ Leptospira lateral flow device detects IgM antibodies in humans against Leptospira in whole blood or serum. It is manufactured by Life Assay, South Africa
16151770|NCT01766830|Device|Leptospira IgG/IgM|This test enables the differential detection of IgG and IgM antibodies to Leptospira interrogans. It is manufactured by Standard Diagnostics, Korea
16151771|NCT01766817|Drug|BMS-986020|
16151772|NCT01766817|Drug|Placebo matching with BMS-986020|
16151773|NCT01766804|Dietary Supplement|Bovine Colostrum|The intervention consists of daily bovine colostrum supplementation given during the induction treatment of ALL therapy for a total of four weeks.
16151774|NCT01766804|Dietary Supplement|placebo|
16151775|NCT01766791|Other|HIT-exercise, low repetition range|High Intensity Resistance Exercise Training, low repetition range, > 75% 1RM
16151776|NCT01766791|Other|HIT-exercise, high repetition range|High Intensity Resistance Exercise Training, high repetition range, 60 - < 75 1RM
16151777|NCT01766791|Other|HIT-exercise with protein|High Intensity Resistance Exercise Training, low repetition range, > 75% 1RM and Protein Supplementation
16151778|NCT01766791|Other|Control|control group, no intervention, maintenance of physical activity
16151779|NCT01766778|Drug|LAF237 (vildagliptin)|Vildagliptin 50mg capsule
16151780|NCT01766778|Drug|Metformin|Metformin maximum tolerance dose
16151781|NCT01766765|Procedure|Jejunostomy|Routine placement of jejunostomy tube following laparoscopic gastrectomy for gastric cancer. Immediately drip 37°C saline 20 ml/h and exchange to drip 37°C enteral nutrition fluid 20 ml/h at postoperative 6 h via jejunostomy tube
16151782|NCT01766765|Other|Early oral nutrition|Free oral nutrition as tolerance allows on POD 1.
16151814|NCT01766453|Behavioral|Standard Exercise|Aerobic exercise with a progressive increase in intensity over 12 weeks.
16151783|NCT01766752|Device|GlucoTab System|Tablet based workflow and decision support system with incorporated software algorithm (GlucoTab) used for glycaemic management in non-critically ill patients with type 2 diabetes at the general ward
16151784|NCT01766739|Biological|GL-ONC1|Patients will be enrolled in groups of three and individually assessed for safety and dose limiting toxicity (DLT).
16151785|NCT01766713|Drug|Ezetimibe|10mg daily oral dose of ezetimibe
16151786|NCT01766700|Behavioral|2 no calorie beverages per day|Weekly and monthly lifestyle weight loss/maintenance classes.
16151787|NCT01766700|Behavioral|2 water beverages per day|Weekly and monthly lifestyle weight loss/maintenance classes.
16151788|NCT01766687|Dietary Supplement|Hydration|
16151789|NCT01766674|Behavioral|Kyphosis spinal strengthening exercises|Investigator developed the intervention protocol (Kyphosis spinal exercises) of targeted spine exercises during our pilot study based upon the literature and clinical experience.We standardized the protocol with a written script and a video. Each exercise session will be preceded by light aerobic activity, ended with cool-down and stretching the neck, chest and all extremities. All participants will be carefully monitored to ensure that all exercises will be performed slowly, with correct body alignment and technique to minimize risk of injury.
16151790|NCT01766661|Procedure|Hand-sewn coloanal anastomosis|After low anterior rectal resection due to low rectal neoplasm patients undergo intestinal reconstructions as hand-sewn coloanal anastomosis with protective loop ileostomy.
16151791|NCT01766661|Procedure|Two staged Turnbull-Cutait procedure|After low anterior rectal resection due to low rectal neoplasm patients undergo intestinal reconstructions as two staged Turnbull-Cutait procedure anastomosis without protective ileostomy.
16151792|NCT01766661|Procedure|Ultralow anterior rectal resection with total mesorectal excision|Standard ultralow anterior rectal resection with total mesorectal excision
16151793|NCT01766648|Device|Far Cortical locking screw fixation|Standard locking screw fixation
16151794|NCT01766648|Device|Standard locking screw fixation|
16151795|NCT01766622|Drug|[18F]-CP18|7mCi, IV (in the vein) at baseline
16151796|NCT01766622|Procedure|PET/ CT|At baseline, Within 3 days after the initial Birinapant dose, A third [18F]-CP18 PET/CT will be obtained within 3 days following cycle 2, day 15 Birinapant therapy
16151797|NCT01766609|Drug|Triamcinolone Acetonide|
16151798|NCT01766596|Procedure|Optical Coherence Tomography|
16151799|NCT01766583|Drug|CC-292 + lenalidomide|CC-292 + lenalidomide
16151800|NCT01766570|Other|Uncontrolled nutritional intervention with a supplemental beverage|Men and women are assigned to an uncontrolled nutritional intervention where they have to consume every day one of the beverage. Half of the subjects consume the experimental beverage containing polyphenols from berries extracts, the other half consume a placebo beverage without polyphenols. The polyphenol containing beverage daily supply 1,84 g of a strawberry and cranberry extract. This amount give the equivalent of 333 mg of polyphenols, thus corresponding to a daily consumption of one cup of berries. The placebo beverage is also a fruit taste beverage, but without polyphenols. Both beverage are isocaloric, with same appearance and taste. A 2 weeks stabilisation period precede the 6 weeks experimental period. During these two periods, subjects are advise to maintain their habitual caloric intake and their habitual activity level, and to avoid consumption of particular food with a high polyphenol content.
16151801|NCT01766570|Other|Placebo|
16151802|NCT01766557|Other|Semi-controlled nutritional intervention with fish protein diet|After a controlled NCEP-based diet for 3 months, women are assigned to a cod fillet diet. At the end of this first 3 months experimental period, participants return to their NCEP-based diet for a wash-out period of 3 months. Then, each group receive the other diet for an additional 3 months period. The fish protein intake come from cod fillets and correspond to 50% of total protein, the remaining dietary proteins being from BPVEM (20%) and vegetable (30%). Lunches incorporating cod fillets are prepared by professional dietitians, provided two time per week, and are self-consumed. Participants make their breakfasts and dinners using foods from a pre-approved list. Alcohol is strictly prohibited during all periods.
16151803|NCT01766557|Other|Semi-controlled intervention with other animal proteins|Prior to experimental period, participants follow a controlled NCEP-based diet for 3 months. Then women are assigned to a diet containing beef, pork, veal, eggs, milk and milk products. At the end of this first 3 months experimental period, participants return to their NCEP-based diet for a wash-out period of 3 months. The two diets are isoenergetic. The protein intake from BPVEM correspond to 70% of total protein, other dietary proteins are from vegetable (30%) origin. Lunches incorporating animal proteins are prepared by professional dietitians, provided two time per week, and are self-consumed. Participants make their breakfasts and dinners using foods from a pre-approved list. The content in n-3 fatty acids is adjusted to provide equivalent amounts of n-3 fatty acids then in the cod protein diet. Alcohol is strictly prohibited during all periods.
16151804|NCT01766544|Other|Standard Practice Group (SPG)|The investigators planned to send a copy of the latest Canadian asthma and COPD guidelines to all PCPs in the Standard Practice (SP) Group at the start of the study period, by mail. No other intervention would be offered during the study, but upon study completion, all control participants would be offered the educational intervention received by the Targeted Intervention Strategy (TIS) Group.
16151805|NCT01766544|Other|TISG|interactive educational interventions, expert mentorship and practice-based tools. 3 interactive sessions, 2 of which would be live meetings of 3h each, and the third hour teleconference.
16151806|NCT01766531|Device|body bioelectrical impedance|
16151807|NCT01766518|Drug|Mycophenolate mofetil|MY-REPT capsule 500~1500mg/day, per oral, capsules twice a day with Tacrolimus, Corticosteroids, Basiliximab post liver transplantation
16151808|NCT01766505|Drug|Candemore tablet|"Candemore tablet 8, 16, or 32mg/tab, per oral, a tablet once a day during 16 weeks.
~dosage is depends on the sitting blood pressure."
16151809|NCT01766505|Drug|Cozzar tablet|Cozzar tablet: 8mg, 16mg, 32mg/tablet, per oral, a tablet a day during 16 weeks dosage depends on sitting blood pressure
16151810|NCT01766492|Radiation|Stereotactic Body Radiation Therapy (SBRT)|Stereotactic body radiation therapy for prostate
16151811|NCT01766479|Radiation|CT colonography|
16151812|NCT01766466|Drug|cangrelor|Open-label cangrelor IV bolus (30 µg/kg), followed by an infusion of 4 µg/kg/min for two hours.
16151813|NCT01766466|Drug|Ticagrelor|"Ticagrelor 180mg dose: administered 0.5 h or 1.5h after the initiation of cangrelor infusion
~Ticagrelor 90mg: 6 or 7 doses (depending on study arm) taken every 12 hours post cangrelor infusion."
16151815|NCT01766453|Behavioral|Bhangra dance exercise|Bhangra Dance classes taught by an instructor.
16151816|NCT01766440|Drug|Calcitriol 3 mcg/g ointment|Topical ointment; twice daily application
16151817|NCT01766414|Drug|C1-esterase inhibitor|intravenously
16151818|NCT01766414|Drug|Endotoxin|intravenously
16151819|NCT01766401|Drug|Placebo|
16151820|NCT01766401|Drug|Vilazadone|Viibryd
16151821|NCT01766375|Drug|Cyclosporin A,mycophenolate mofetil,Methotrexate|GVHD is prevented by CSA+MMF+MTX in sibling allogeneic hematopoietic stem cell transplantation (starting from day -1, 3mg/kg of CSA was infused by continuous intravenous drip until gastrointestinal function returned normal when method of administration was changed to oral administration.
16151822|NCT01766362|Procedure|PRPC using Pascal laser|
16151823|NCT01766349|Behavioral|respiratory muscle performance|Respiratory muscle performance will include measurements of respiratory muscle strength and pulmonary function testing.
16151824|NCT01766336|Drug|Group 1 ELND005|
16151825|NCT01766336|Drug|Group 2 ELND005|
16151826|NCT01766323|Drug|Modafinil|Oral modafinil at a dose of 100mg b.i.d along with the dose of oral morphine required for pain palliation
16151827|NCT01766323|Drug|Placebo|Oral placebo b.i.d, along with the dose of oral morphine required for pain palliation
16151828|NCT01766310|Drug|Folic Acid|yellow tablet contained 5mg of folic acid, manufactured from the Government Pharmaceutical Organization, Ministry of Public Health, Thailand
16151829|NCT01766310|Drug|placebo|sugar tablet manufactured to mimic folic acid tablet
16151831|NCT01766284|Device|NIRIS 1300e|Optical coherence tomography (OCT) is similar to ultrasound pulse-echo imaging, with optical scatter rather than acoustic reflectivity being measured. OCT employs harmless near-infrared light technology which uses low coherence interferometry to produce an image (based on optical scattering) of tissue microstructure.
16151832|NCT01766271|Behavioral|Health Coaching|biweekly health coaching for 5 months
16151833|NCT01766271|Genetic|9p21|Genetic testing results of 9p21
16151834|NCT01766271|Other|Standard Risk Assessment|All 4 arms are assigned to receive standard assessment on coronary heart disease risk
16151835|NCT01766258|Drug|ODM-101 65mg Carbidopa|
16151836|NCT01766258|Drug|ODM-101 105mg Carbidopa|
16151837|NCT01766258|Drug|Stalevo|
16151838|NCT01766245|Drug|semaglutide|For subcutaneous (s.c., under the skin), single dose administration at two separate dosing visits.
16151839|NCT01766219|Drug|6,8-bis(benzylthio)octanoic acid|Given IV
16151840|NCT01766206|Biological|MenACWY-CRM (Menveo)|One dose administered intramuscularly preferably into the anterolateral aspect of the thigh in infants or into the deltoid muscle in children, adolescents and adults.
16151841|NCT01766193|Procedure|vaginal delivery|
16151842|NCT01766193|Procedure|forceps extraction|vaginal delivery by forceps extraction
16151843|NCT01766193|Procedure|vacuum extraction|vaginal delivery by vacuum extraction
16151844|NCT01766193|Procedure|cesarean section|
16151845|NCT01766180|Drug|Fruitflow-II|150 mg/day for 3 months, orally
16151846|NCT01766180|Drug|resVida|150 mg/day for 3 months, orally
16151847|NCT01766167|Drug|MP-424|Low
16151848|NCT01766167|Drug|MP-424|Middle
16151849|NCT01766167|Drug|MP-424|High
16151850|NCT01766167|Drug|MP-424|Multiple
16151851|NCT01766154|Drug|Tirofiban|A single high-dose bolus (3 min IV infusion) of tirofiban (25 µg/kg)
16151852|NCT01766141|Other|Spinal manipulation|Spinal manipulation will consist of a single high velocity low amplitude thrust to a hypomobile vertebral segment determined by the treating clinician to contribute to the problem.
16151853|NCT01766128|Drug|Zonisamide|The first arm will be treated by zonisamide and the second one will only receive placebo
16151854|NCT01766115|Drug|Telaprevir|HCV Protease Inhibitor
16151855|NCT01766102|Procedure|Intra-operative Mammography|The patient's breast specimen will be imaged in the operating room in an intra-operative imaging device - Biovision SN #30042
16151856|NCT01766102|Procedure|Standard Mammography|There is not an added device associated with this arm.
16151857|NCT01766089|Drug|Remifentanil|Remifentanil (0.1 µg/kg/min) starting 5 min before induction of anaesthesia and continued until peritoneal closure.
16151858|NCT01766089|Drug|Dexmedetomidine|dexmedetomidine (0.4 µg/kg/h) starting 20 before induction of anaesthesia and continued until peritoneal closure
16151859|NCT01766076|Other|atorvastatin, Lipitor®|PBMC collected for immune activation assays using flowcytometry
16151860|NCT01766076|Drug|Placebo|PBMC collected for immune activation assays using flowcytometry
16151861|NCT01766063|Drug|Interferon beta-1b (Betaferon, BAY 86-5046)|Patients will be followed-up for 24 months
16151862|NCT01766050|Drug|Caffeine|
16151863|NCT01766050|Drug|Losartan|
16151864|NCT01766050|Drug|Omeprazole|
16151865|NCT01766050|Drug|Dextromethorphan|
16151866|NCT01766050|Drug|Midazolam|
16151867|NCT01766050|Biological|Belatacept|
16151868|NCT01766037|Device|Aspiration Therapy (AspireAssist)|Use of the AspireAssist device in aspiration therapy
16151869|NCT01766037|Behavioral|Lifestyle Therapy|Lifestyle therapy is a behavioral, diet and physical activity education program
16151870|NCT01766024|Drug|Interferon beta-1a|Each volunteer will receive 1 subcutaneous (sc) injection of the study drug BCD-033 (interferon beta-1a) and 1 sc injection of active comparator Rebif (interferon beta-1a) at a dose of 44 µg with an interval of at least 14 days.
16151871|NCT01766011|Other|study pre-term formula|24 kcal/fl oz pre-term formula for in-hospital use
16151872|NCT01765998|Drug|Probiotic|Clinical evaluation according to the Crohn's activity scale
16151873|NCT01765998|Drug|Placebo|
16151874|NCT01765985|Device|PSORIAMED|"V0 : Selection: Information of the patient, control of inclusion and non inclusion criteria.
~V1 : Control of inclusion and non inclusion criteria (treatment against psoriasis have to be discontinued for at least 3 weeks and 3 months for anti-IL12/23). Clinical scores and photographs. Explanation of the functioning of the device, then the treatment is followed at home, twice a day 5 minutes. 10% salicylic acid ointment will be applied after each session.
~V2 : End of the treatment (12 weeks after V1). Clinical scores and photographs. V3 : End of the follow-up (24 weeks after V1). Clinical scores and photographs."
16151875|NCT01765985|Device|PLACEBO|"V0 : Selection: Information of the patient, control of inclusion and non inclusion criteria.
~V1 : Control of inclusion and non inclusion criteria (treatment against psoriasis have to be discontinued for at least 3 weeks and 3 months for anti-IL12/23). Clinical scores and photographs. Explanation of the functioning of the device, then the treatment is followed at home, twice a day 5 minutes. 10% salicylic acid ointment will be applied after each session.
~V2 : End of the treatment (12 weeks after V1). Clinical scores and photographs. V3 : End of the follow-up (24 weeks after V1). Clinical scores and photographs."
16151876|NCT01765972|Device|etafilcon A with Lacreon|contact lens with Lacreon
16151877|NCT01765972|Device|etafilcon A with Lacreon with print|contact lens with Lacreon and cosmetic print
16151878|NCT01765972|Device|etafilcon A with print|contact lens with print
16151879|NCT01765972|Device|Spectacles (habitual)|Spectacles
16151880|NCT01765959|Other|Auricular acupuncture (AA)|Auricular acupuncture (AA) group will receive treatment twice a week for four weeks. Each session will take approximately 60 minutes in which there will be active treatment time for 40 minutes. During treatment the respondents will have 5 thin sterile, disposable steel needles superficially placed in each outer ear. Before needle insertion the outer ears will be cleaned with disinfection solution. During treatment the respondents will sit down in silence; with eyes shut and focus on a normal calm breathing. The acupuncturist will not be in the room during treatment. After 40 minutes the respondents remove the needles and put them in a box suited for disposed needles. If needed, assistance to remove needles will be given from the acupuncturist.
16151881|NCT01765959|Other|cognitive behavioral therapy (CBT)|"Cognitive behavioral therapy (CBT) group will receive manual based sessions for sleeping disorders. The group meets once a week during six weeks according to following program:
~Session 1 - introduction, self-help concept Session 2 - biology of sleep, sleep restriction, Session 3 - stimulus control Session 4 - visualization as relaxation, Session 5 - how to deal with negative and automatic thoughts, Session 6 - how to solve problems, planning for the future"
16151882|NCT01765946|Drug|Metformin|Metformin tablets 500 mg tris in die (tid)
16151883|NCT01765946|Drug|placebo|
16151884|NCT01765933|Dietary Supplement|DMAA|no placebo
16151885|NCT01765920|Drug|Ergoferon|5 ml 3 times a day
16151886|NCT01765920|Drug|Placebo|5 ml 3 times a day
16151887|NCT01765907|Device|HIFU|
16151888|NCT01765894|Other|45 minutes of moderate exercise at the fasted state. Before test day 2: 3 days of carbohydrate loading.|
16151889|NCT01765881|Drug|Misoprostol|administration of Misoprostol 25 micrograms capsule by intravaginal route every 4 hours, up to 4 capsules
16151890|NCT01765881|Drug|Dinoprostone|administration of one sustained released pessary of 10 milligrams by intravaginal route
16151891|NCT01765868|Drug|Betrixaban|Single Oral dose 80 mg betrixaban and Single IV (15 ml) carbon 14 80 micrograms Betrixaban administered over 15 minutes, 2 hours after the oral dose
16151892|NCT01765855|Drug|Betrixaban single oral dose|
16151893|NCT01765842|Biological|Rituximab|Only one cycle of rituximab will be administered in this arm.
16151894|NCT01765829|Drug|Discontinuation antipsychotic treatment|Dose reduction until withdrawal
16151895|NCT01765829|Drug|Antipsychotic treatment|Antipsychotic treatment is not modify during the study, it is administered according to common clinical practice
16151896|NCT01765816|Behavioral|high intensity interval training|
16151897|NCT01765816|Behavioral|moderate intensity training|
16151898|NCT01765803|Drug|Mellaril|Subjects will undergo a physical exam including an electrocardiogram (EKG) and have blood drawn before treatment. A single 50 gm dose of thioridazine (Mellaril) will be given to eligible subjects. A second blood draw will occur at 24 hours post-treatment.
16151899|NCT01765790|Biological|Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody|"Dosing every 2 weeks
~Intravenous injection"
16151900|NCT01765790|Biological|Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody|"Dosing weekly
~Intravenous injection"
16151901|NCT01765777|Procedure|Osteopathic Manipulative Medicine|
16151902|NCT01765777|Procedure|Phototherapy|
16151903|NCT01765764|Drug|bimatoprost solution|Bimatoprost solution once a day or twice a day applied to each eyebrow for 7 months.
16151904|NCT01765764|Drug|Vehicle to bimatoprost solution|Vehicle to bimatoprost solution once or twice a day applied to each eyebrow for 7 months.
16151905|NCT01765751|Procedure|Manual Cervical Distraction|Manual Cervical Distraction (MCD) is a form of Low Velocity Variable Amplitude Spinal Manipulation (LVVA-SM). MCD procedure is performed with participant lying prone on a load instrumented table with moveable headpiece allowing guided head movement while recumbent. Clinician gently grasps posterior aspect of participant's neck with a broad contact (contact hand) between thumb and index finger at specific vertebral level. With opposite hand, clinician grasps control handle. Using contact hand, clinician exhibits superior traction to maintain a contact at a single vertebral level and ensuring a gentle movement via contact with control handle. Goal is to create a slow rhythmic (1-3 sec) localized distractive movement. In this trial, only axial distraction (Cox protocol 1) will be used.
16151906|NCT01765738|Device|PICC (Cook, Bard)|Comparison of antibiotic coated PICC vs. non-coated PICC
16151907|NCT01765725|Behavioral|Patient education program|Patient education program, 8 meetings, every other week, 2,5 hours per meeting.
16151908|NCT01765712|Procedure|Anterior Cruciate ligament reconstruction bone patellar tendon bone autograft|
16151909|NCT01765712|Biological|Platelet Rich Plasma|
16151910|NCT01765699|Device|Primary knee arthroplasty|Patients undergoing primary knee arthroplasty
16151911|NCT01765686|Device|Harmonic Scalpel (Ethicon Endo-Surgery, USA)|
16151912|NCT01765686|Device|Ligasure Small Jaw (Covidien, USA)|
16151913|NCT01765673|Device|Vibrotactile stimulation|Comparison of the effects of different vibratory characteristics on the frequency of swallowing, time of initiation of swallowing with stimulation and urge to swallow. Will compare frequency of vibration, mode of vibration, pressure of device against neck, and duration of vibration. Each session will last no more than 1 hour with short breaks. Each participant can volunteer for up to three nonconsecutive sessions.
16151914|NCT01765660|Biological|Mesenchymal stem cells|Mesenchymal stem cells will be intravenously infused via a central venous catheter(at a dose of 1×10^6 cells/kg, over 15 mins) every two weeks, four times for a cycle.
16151915|NCT01765660|Biological|Non-mesenchymal stem cells|Other second line drugs are taken.
16151916|NCT01765647|Other|AGY|AGY is a natural health product produced in egg yolks
16151917|NCT01765634|Biological|Mesenchymal stem cells|Mesenchymal stem cells will be intravenously infused via a central venous catheter(at a dose of 1×10^6 cells/kg, over 15 min) each week, four times for a cycle.
16151918|NCT01765634|Biological|Non-mesenchymal stem cells|Other second line drugs are taken.
16151919|NCT01765621|Other|DDI+ System and Pharmacogenetic Data|
16151920|NCT01765608|Drug|Zonisamide|Zonisamide (Zonegran®) tablets will be administered according to a forced stepwise weekly titration scheme with weekly 100 mg escalations from 100 to 300 mg daily according to the manufacturer Eisai Inc.
16151921|NCT01765608|Drug|Placebo|
16151922|NCT01765608|Device|nCPAP|
16151923|NCT01765595|Other|DDI+|
16151924|NCT01765582|Drug|5-fluorouracil|Participants in Arm A will receive 3200 milligrams per square meter (mg/m^2) by 48-hour continuous intravenous (IV) infusion every 2 weeks, during the 4-6 months' induction followed by maintenance therapy including bolus dose of 400 mg/m^2, followed by a 46-hour continuous infusion (2400 mg/m^2) every 2 weeks per investigator's discretion. Participants in Arm B and C will receive a bolus dose of 400 mg/m^2, followed by a 46-hour continuous infusion (2400 mg/m^2) every 2 weeks during the 4-6 months of induction and maintenance per investigator's discretion.
16151925|NCT01765582|Drug|bevacizumab|Participants will receive 5 mg/kg IV every 2 weeks during the first 4-6 months induction phase, followed by 5 mg/kg IV every 2 weeks or 7.5 mg/kg IV every 3 weeks during maintenance therapy, and 2.5 mg/kg per week reinduction after disease progression.
16151926|NCT01765582|Drug|capecitabine|Participants will receive 1000 or 850 mg/kg orally twice daily as per investigator's discretion on Day 1 to 14, repeated every 3 weeks in maintenance phase.
16151927|NCT01765582|Drug|irinotecan|Participants will receive IV infusion of 165 mg/m^2 over 1 hour every 2 weeks (Arm A) or IV infusion of 180 mg/m^2 over 1 hour in 2 x 2 weeks cycles alternating months (in Arm B), during 4-6 months induction phase.
16151928|NCT01765582|Drug|folinic acid|Participants will receive IV infusion of 200 mg/m^² (Arm A) or 400 mg/m^2 (Arm B or C) over 2 hours every 2 weeks, during 4-6 months induction phase followed by IV infusion of 400 mg/m^2 in the maintenance therapy.
16151929|NCT01765582|Drug|oxaliplatin|Participants will receive 85 mg/m^2 over 2 hours as IV infusion every 2 weeks (Arm A, C ) or 2 x 2 week cycles alternating months (Arm B), during 4-6 months induction phase .
16151930|NCT01765569|Drug|Digoxin|Participants received single oral dose of digoxin 0.25 mg tablet on Day 1 and Day 29.
16151931|NCT01765569|Drug|Vemurafenib|Participants received vemurafenib 960 mg tablet orally BID from Day 8 to Day 35.
16151932|NCT01765556|Drug|ketoconazole|multiple doses of ketoconazole in Period B and C
16151933|NCT01765556|Drug|vemurafenib|single dose of vemurafenib in Period A and C
16151934|NCT01765543|Drug|Rifampin|Rifampin at a dose of 600 mg as capsules orally once daily will be administered from Days 8 through 23 (Periods B and C).
16151935|NCT01765543|Drug|Vemurafenib|Participants, after an overnight fast of at least 10 hours, will receive vemurafenib at a dose of 960 mg as film-coated tablets orally on Day 1 (Period A) and on Day 17 (Period C).
16151936|NCT01765530|Device|ETT cleaning maneuver|"EndOclear device will be used for ETT cleaning maneuver. This is a commercially available device. It consists of an ETT cleaning apparatus with a flexible central tube and a cleaning device at its distal end. The cleaning device has a mechanically expandable mesh structure which can be adapted to selectively move between a radially-collapsed position and a radially-expanded one. In operation, the collapsed cleaning apparatus is inserted into the ETT through a Y-shaped connector. The device is then expanded by a safety toggle protected trigger mechanism that, when fired, presses the device's smooth silicone disc against the inside surface of the ETT. The cleaning apparatus is then pulled out of the ETT removing mucus deposits and secretions.
~We will add endOclear to the standard ICU practice, scheduling the systematic use of the device every 8 hours for the whole intubation period."
16151937|NCT01765517|Dietary Supplement|Probiotics|Administration of probiotics daily for 26 weeks and compared to placebo
16151938|NCT01765517|Dietary Supplement|Placebo|Administration of placebo daily for 26 weeks and compared to probiotics group
16151939|NCT01765491|Other|Split-dose polyethylene glycol|Half gallon of polyethylene glycol to be taken between 7-9 pm on the day before colonoscopy and the remaining half between 7-9 am on the day of colonoscopy
16151940|NCT01765491|Other|Morning-only polyethylene glycol|One gallon of polyethylene glycol to be taken between 5am and 9am on the day of colonoscopy
16151941|NCT01765478|Drug|HM71224 single ascending dose|
16151942|NCT01765478|Drug|HM71224 food effect|
16151943|NCT01765478|Drug|HM71224 Multiple ascending dose|
16151944|NCT01765465|Drug|Rowachol|
16151945|NCT01765465|Drug|Placebo|
16151946|NCT01765452|Drug|Closone|75mg/100mg, 8weeks, PO
16151947|NCT01765452|Drug|Plavix with Astrix|75mg, 100mg a day, 8weeks, PO
16151948|NCT01765439|Dietary Supplement|VSL#3 (Original De Simone formulation)|Study subjects will receive two sachets of VSL#3 probiotic (ie 2x900 billions of live bacteria) per day (one in the morning, one in the evening). The intervention period will be 6 weeks (plus or minus 5 days).
16151949|NCT01765426|Biological|TDV|TDV suspension for intradermal administration
16151950|NCT01765426|Drug|Placebo|Phosphate buffered saline (PBS)
16151951|NCT01765413|Biological|Varicella-zoster virus|
16151952|NCT01765413|Biological|Yellow Fever Vaccine|
16151953|NCT01765413|Biological|Placebo|
16151954|NCT01765400|Drug|Prasugrel 10 mg daily x 2 weeks|
16151955|NCT01765400|Drug|Clopidogrel 75 mg daily x 2 weeks|
16151956|NCT01765387|Behavioral|Spa session|
16151957|NCT01765374|Device|ESAOTE MyLab60|US evaluation at different time points
16151958|NCT01765374|Drug|Rituximab|
16151959|NCT01765348|Behavioral|Syntax treatment via sentence-combining method|"Sentence combining method is a discrete trial method that teaches children to form complex sentences of a same structure through drilling and modeling.
~Treatments are conduced by school-speech therapist once two weeks for 8 sessions."
16151960|NCT01765348|Behavioral|Syntax treatment managed by narrative-based treatment|Target structures are embedded into narrative stories. Children are exposed to these stories and are scaffolded to form the target sentence structure through answering questions, cloze passage and story retell. Treatment are conduced by school-speech therapist once two weeks for 8 sessions.
16151961|NCT01765335|Device|NICaS system|NICaS parameters (cardiac output and total peripheral resistance) and serum BNP levels will be processed in an excel sheet including study reference number to keep confidentiality
16151962|NCT01765322|Device|ZILOS-TK IVOS Analyzer|The subjects are going to participate the treatment of assisted hatching in vitro fertilization by Zona Infrared Laser Optical System (ZILOS-TK,Hamilton Thorne Biosciences,USA)
16151963|NCT01765309|Procedure|Bilateral mastectomy with reconstruction|In each patient enrolled in the study, botulinum toxin was injected into one pectoralis muscle while saline placebo was injected on the opposite side in a randomized blinded fashion
16151964|NCT01765296|Drug|CG100649|2 mg capsule
16151965|NCT01765296|Drug|Celecoxib|200 mg capsule
16151966|NCT01765296|Drug|Placebo|Mimic for CG100649 2 mg capsule and for celecoxib 200 mg capsule
16151967|NCT01765283|Biological|HepaStem|
16151968|NCT01765270|Drug|Saxagliptin|one 5-mg saxagliptin tablet daily
16151969|NCT01765270|Drug|Placebo|5mg placebo tablet daily
16151970|NCT01765257|Drug|AZILECT®|
16151971|NCT01765257|Drug|Placebo|
16151972|NCT01765244|Drug|Anterior lamellar nanostructured artificial human cornea.|Implantation of an anterior lamellar nanostructured artificial human cornea with allogeneic cells from dead donors embedded in a fibrin-agarose scaffold
16151973|NCT01765244|Other|Amniotic membrane transplantation|Implantation of an amniotic membrane graft to cover the corneal scarring using the mixed graft/patch technique.
16151974|NCT01765231|Drug|Entecavir prophylaxis|Entecavir 0.5mg daily from day 1 of antitumor therapy to at least 6 months after completing antitumor therapy
16151975|NCT01765231|Drug|Observation arm|Entecavir 0.5mg daily will be prescribed for patients with hepatitis B virus reactivation.
16151976|NCT01765218|Drug|Topiramate|Infants assigned to the topiramate group will receive 5mg/kg of topiramate daily enterally for a total of 5 doses. The first dose will be administered as soon as possible on admission.
16151977|NCT01765218|Drug|Placebo|A placebo identical in appearance to the active agent (topiramate)
16151978|NCT01765205|Device|Pulse Oximetry using the INVOS (In Vivo Optical Spectroscopy) Cerebral/Somatic Oximeter|Up to 50 healthy infants and up to 10 infants with CHD will receive the pulse oximetry using the INVOS Cerebral/Somatic Oximeter for 15 minutes to determine the effectiveness to measure somatic oxygen saturation. The pulse oximeter will be placed on the infants forehead with a hat and around the infants thigh to measure oxygen saturation.
16151979|NCT01765192|Drug|Roflumilast|Roflumilast was supplied in tablets.
16151980|NCT01765192|Drug|Roflumilast placebo|Roflumilast placebo was supplied in tablets.
16151981|NCT01765192|Drug|Montelukast|Montelukast was supplied in tablets.
16151982|NCT01765179|Drug|Oral testosterone undecanoate|Initial dose 200 mg T, BID; dose titration Days 42 and/or 84 based on serum T levels obtained 3-5 hours post AM dose on Days 30 and 72. Dosages increased or decreased in 50 mg increments.
16151983|NCT01765166|Behavioral|SSGRIN-Parent Guide|All children will receive traditional SSGRIN(Social Skills Group Intervention), but parents will vary in the level of parent treatment. Families will be randomly assigned to one of four treatment conditions(approximately 25% each): (a) Traditional SSGRIN child treatment with no parent involvement (ChO), (b) SSGRIN child treatment plus parent attention control (PAC), (c) SSGRIN child treatment plus Parent Guide-Home-study treatment (PG-HS), or (d) SSGRIN child treatment plus traditional Parent Guide treatment (PG).
16151984|NCT01765153|Behavioral|Endurance|Participants are trained daily to walk on a treadmill for as fast and as long as possible. A harness supporting part of their body weight can be used if needed. Assistance from a trainer is used if needed. A physical therapist supervises the training.
16151985|NCT01765153|Behavioral|Precision|Participants train daily to walk over ground on 15 m straight hallway with obstacles they must step over, and targets they must step onto.
16151986|NCT01765140|Drug|3,4-diaminopyridine|Treatment use of 3,4-DAP for patients with congenital myasthenic syndrome (CMS)
16151987|NCT01765114|Drug|PEG-Formulation|
16151988|NCT01765101|Other|customized insoles|To study the immediate, short-term and intermediate-term therapeutic effects, including psychological function, physical activity , functional performance and quality of life, physical functional ability, pain and balance performance
16151989|NCT01765101|Other|ready made insoles|To study the immediate, short-term and intermediate-term therapeutic effects, including psychological function, physical activity , functional performance and quality of life, physical functional ability, pain and balance performance
16151990|NCT01765088|Drug|Temozolomide|dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days
16151991|NCT01765088|Drug|α-IFN|3mIU (3million) D1，3，5
16151992|NCT01765036|Drug|SonoVue®|An intravenous 4.8 ml SonoVue® bolus injection was administered to each patient during the procedure
16151993|NCT01765023|Drug|Period I : atorvastatin, Period II : atorvastatin and metformin|
16151994|NCT01765023|Drug|Period I : metformin, Period II : atorvastatin and metformin|
16151995|NCT01765010|Drug|Calcitriol|
16151996|NCT01765010|Drug|Alfacalcidol|
16151997|NCT01765010|Drug|Cholecalciferol|
16151998|NCT01765010|Drug|Placebo|
16151999|NCT01764997|Drug|Sarilumab|Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous
16152000|NCT01764997|Drug|Etanercept|Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous
16152001|NCT01764997|Drug|Methotrexate|Dispensed according to local practice.
16152002|NCT01764997|Drug|Placebo (for sarilumab)|
16152003|NCT01764997|Drug|Placebo (for etanercept)|
16152004|NCT01764997|Drug|Adalimumab|Pharmaceutical form: Solution for injection in pre-filled syringe; Route of administration: Subcutaneous
16152005|NCT01764984|Device|Total knee arthroplasty|Total knee arthroplasty using parapatellar approach and postero-stabilized implants.
16152006|NCT01764971|Other|IQ assessment and visual- motor assessment|Psychological examination and evaluation for both groups to diagnose those with behavioral and /or cognitive dysfunction.
16152007|NCT01764971|Other|EEG,brain imaging|For patients with cognitive or behavioral deficit, MRI brain and quantitative EEG will be done to identify any CNS abnormality.
16152008|NCT01764945|Drug|BI 201335 (Reference)|soft gelatine capsule, oral administration
16152009|NCT01764945|Drug|BI 201335 (Test)|oral solution 3
16152010|NCT01764945|Drug|BI 201335 (Test)|oral solution 3
16152011|NCT01764945|Drug|BI 201335 (Test)|oral solution 2
16152012|NCT01764945|Drug|BI 201335 (Reference)|soft gelatine capsule, oral administration
16152013|NCT01764945|Drug|BI 201335 (Test)|oral solution 1
16152014|NCT01764945|Drug|BI 201335 (Test)|oral solution 1
16152015|NCT01764945|Drug|BI 201335 (Test)|oral solution 2
16152016|NCT01764932|Procedure|Fluoroscopic imaging|Contrast media (5 mL) will be injected through the catheter and fluoroscopic images will be obtained and saved in the lateral and antero-posterior projections.
16152017|NCT01764919|Radiation|[124I]FIAU|A single intravenous injection of 5 mCi[124I]FIAU in patients with diabetic foot infection who will undergo 2 PET-CT scanning.
16152018|NCT01764906|Device|Novosis|
16152019|NCT01764906|Procedure|Iliac crest bone graft|
16152020|NCT01764893|Other|PTNS plus solifenacin|12 weekly treatments with percutaneous tibial nerve stimulation with 5 mg of solifenacin; an additional 4 weeks of solifenacin for a total of 15 weeks of study drug.
16152021|NCT01764893|Other|Placebo|12 weekly treatments with percutaneous tibial nerve stimulation with placebo; an additional 4 weeks of placebo for a total of 15 weeks of placebo.
16152022|NCT01764880|Drug|SST0001 (Roneparstat)|SST0001 once daily for 5 or 10 days in a cycle of 28 days.
16152023|NCT01764867|Drug|Escitalopram|Recommended dosage range of escitalopram is 10-20mg per day. The duration will last up to 6-12 weeks until progression or unacceptable intolerability develops.
16152024|NCT01764867|Drug|Mirtazapine|Recommended dosage range of mirtazapine is 30-45mg per day. The duration will last up to 6-12 weeks until progression or unacceptable intolerability develops.
16152025|NCT01764867|Other|modified electroconvulsive therapy|Up to 6-10 sessions of mECT will be performed for selected participants who fails to remit to initial AGT intervention during 6 to 12-week period.
16152026|NCT01764867|Other|repetitive transcranial magnetic stimulation|Up to 20 sessions of rTMS will be performed for selected participants who fails to remit to initial AGT intervention during 6 to 12-week period.
16152027|NCT01764867|Drug|Fluoxetine|Fluoxetine may be prescribed for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
16152028|NCT01764867|Drug|Citalopram|Citalopram may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
16152029|NCT01764867|Drug|Escitalopram|Escitalopram may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
16152030|NCT01764867|Drug|Paroxetine|Paroxetine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
16152031|NCT01764867|Drug|Sertraline|Sertraline may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
16152032|NCT01764867|Drug|Fluvoxamine|Fluvoxamine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
16152033|NCT01764867|Drug|Venlafaxine|Venlafaxine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
16152034|NCT01764867|Drug|Duloxetine|Duloxetine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
16152035|NCT01764867|Drug|Mirtazapine|Mirtazapine may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
16152036|NCT01764867|Drug|Bupropion|Bupropion may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
16152037|NCT01764867|Drug|Trazodone|Trazodone may be used for participants who are randomly assigned to the Treatment As Usual (TAU) arm based on clinician's judgement.
16152038|NCT01764854|Drug|AZD1722 (in-patient)|doses between 5 and 60 mg BID may be administered based on tolerability in a CPU setting
16152039|NCT01764854|Drug|Placebo (in-patient)|Placebo, size and color matched to experimental drug administered in a CPU
16152040|NCT01764854|Drug|AZD1722 (out-patient)|doses between 5 and 45 mg BID
16152041|NCT01764854|Drug|Placebo|Placebo, size and color matched to experimental drug
16152042|NCT01764841|Drug|Ciprofloxacin DPI (BAYQ3939)|Participants received 32.5 mg ciprofloxacin hydrated (corresponding to 50 mg dry powder) administered BID (every 12 hours) using T-326 powder inhaler device.
16152043|NCT01764841|Drug|Placebo|Participants received placebo matched to ciprofloxacin 32.5 mg powder (containing 40 mg dry powder) administered BID (every 12 hours) using T-326 powder inhaler device.
16152044|NCT01764828|Drug|Refametinib (BAY86-9766)|
16152045|NCT01764828|Drug|Gemcitabine|
16152046|NCT01764815|Device|directSTN Acute lead connected to external neurostimulator|Test phase will be performed intra-operatively, prior to chronic lead implant
16152047|NCT01764802|Other|behavioral, psychological or informational intervention|Participate in enhanced standard care
16152048|NCT01764802|Other|behavioral, psychological or informational intervention|Participate in psychological intervention
16152049|NCT01764789|Other|questionnaire administration|Ancillary studies
16152050|NCT01764789|Procedure|quality-of-life assessment|Patients will participate in a quality life assessment.
16152051|NCT01764789|Procedure|psychosocial assessment and care|Participate in multi-component biobehavioral intervention
16152052|NCT01764789|Behavioral|behavioral intervention|Participate in multi-component biobehavioral intervention
16152053|NCT01764789|Other|cognitive intervention|A multi-component intervention based on cognitive and behavioral principles will be used. It combines effective intervention strategies selected for their relevance to patients with recurrent cancer.
16152054|NCT01764789|Other|educational intervention|Participate in multi-component biobehavioral intervention
16152055|NCT01764776|Drug|LDE225|LDE225
16152056|NCT01764750|Drug|Intrasite Vancomycin|Intrasite Vancomycin is placement of lyophilized Vancomycin powder directly into the surgical site at the completion of surgery.
16152057|NCT01764750|Drug|IV Vancomycin|IV Vancomycin is the standard route for systemic antibiotic surgical site wound infection prophylaxis.
16152058|NCT01764737|Drug|VX15/2503|single dose intravenous administration
16152059|NCT01764737|Drug|Placebo|single dose intravenous administration
16152060|NCT01764724|Behavioral|Mock package questionnaire|Within a online questionnaire we exposed participants randomly to 4 mock packages differing only by the nutrition claim it carried and asked participants to answer several questions on attitudes and understanding after each mock package.
16152061|NCT01764711|Drug|Cosyntropin administration|After 30 minutes of rest in the seated position, participants will be given cosyntropin intravenously. Blood samples will be taken 30 minutes pre-drug administration, 30 minutes post and 60 minutes post drug administration.
16152062|NCT01764698|Behavioral|CALM-SUD|6-session group for anxiety disorders. Cognitive behavioral therapy including self-monitoring, relaxation, cognitive restructuring, exposure therapy, and relapse prevention. In addition, participants in this arm are also enrolled in an Intensive Outpatient Program for their substance use disorder. The program is run by an outpatient addictions facility and includes up to 16 weeks of groups that meet 3 to 4 times per week in addition to up to 10 individual sessions of therapy. The group model includes motivational interviewing, cognitive behavioral therapy, contingency management, and relapse prevention skills.
16152063|NCT01764698|Behavioral|Treatment as usual|The program is run by an outpatient addictions facility and includes up to 16 weeks of groups that meet 3 to 4 times per week in addition to up to 10 individual sessions of therapy. The group model includes motivational interviewing, cognitive behavioral therapy, contingency management, and relapse prevention skills.
16152064|NCT01764685|Drug|Topiramate|Max therapeutic dose of 150mg/day
16152065|NCT01764685|Behavioral|Medical Management|Medical Management (MM; Pettinati, 2004) will support patients' efforts to reduce their drinking. The study nurse makes direct recommendations for reducing drinking to sensible levels. The first session will use the brochure A Guide to Sensible Drinking (WHO 1996). The patient is provided with information about pharmacotherapy and the importance of adherence to topiramate/placebo. Subsequent treatment sessions (15-25 minutes) will be conducted at each study visit, during which the nurse will perform an assessment of the patient's drinking, monitor his/her medication adherence, and make recommendations to follow until the next visit. Men will be advised to consume no more than 2 drinks/day and 8 drinks/week; women will be advised to consume no more than 1 drink/day and 4 drinks/week.
16152066|NCT01764685|Drug|Placebo|Placebo
16152067|NCT01764672|Drug|Methylphenidate|Oral dose 40mg (2 x 20mg)
16152068|NCT01764672|Other|Placebo|Oral intake of 2 placebo tablets
16152069|NCT01764659|Other|Contrast-enhanced 4D computed tomography|All enrolled patients each underwent three CT scans: a 4DCT immediately following a contrast-enhanced 3DCT and an individually optimized contrast-enhanced 4DCT.
16152070|NCT01764646|Radiation|Intensity modulated radiation therapy|Minimize radiation doses to surrounding area
16152071|NCT01764646|Radiation|Volumetric modulated arc therapy|Highly conformational dose distribution
16152072|NCT01764646|Radiation|Image guided radiation therapy|Follow target by the use of fiducial markers and ERB
16152073|NCT01764633|Biological|Evolocumab|Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.
16152074|NCT01764633|Drug|Placebo|Administered subcutaneously using a spring-based prefilled 1.0 mL autoinjector/pen.
16152075|NCT01764620|Other|Elastic taping applied with tension|
16152076|NCT01764620|Other|Elastic taping applied without tension|
16152077|NCT01764620|Other|Fatigue protocol|
16152078|NCT01764607|Drug|Sirolimus|Patients randomized to this arm of the study will receive sirolimus from the time of randomization at least until 5 weeks or the removal of the skin tumor. Nephrology will determine/manage the immunosuppressant therapy.
16152079|NCT01764594|Biological|CDP7657|"CDP7657 100 mg/ ml solution
~30 mg/ kg initial dose
~15 mg/ kg every other week
~10 weeks"
16152080|NCT01764594|Other|Placebo|Placebo comparator
16152081|NCT01764581|Procedure|Tacrolimus regulation according to ImmuKnow values|Tacrolimus dose was reduced by 25% when ImmuKnow values were below 130 ng/mL ATP and increased by 25% when ImmuKnow values exceeded 450 ng/mL. Further reductions or increases were made after serial measures until ImmuKnow values stabilized between 130 and 450 ng/mL ATP. The values of 130 and 450 ng/mL ATP were previously documented as thresholds for risks of infection and rejection, respectively with a value of 280 ng/mL corresponding with the greatest negative predictive value for either event
16152082|NCT01764568|Behavioral|Metacognitive Training (MCT)|The metacognitive group training program that will form the basis of the 16 session MCT intervention has been described in previous research (Moritz & Woodward 2007a; Moritz & Woodward 2007b; Moritz 2011) and can be obtained online at no cost (www.uke.de/mkt). This experimental intervention will consist of two 8-module cycles occurring twice a week for 8 weeks, for a total of 16 sessions. Each module will include a 45 to 60 minute instructor-led group session using PowerPoint slides and homework assignments to facilitate learning. Groups will consist of 4-10 subjects. Subjects will be able to attend the alternate (Cognitive Remediation) group after completion of the MCT group if they wish.
16152083|NCT01764568|Behavioral|Cognitive Remediation (CR)|The CR group will use a computerized cognitive remediation program that has been used with schizophrenia patients, Scientific Brain Training Pro (SBT Pro; Vianin et al, 2010). Modules focus on attention, working memory, verbal memory, and planning and reasoning. Each session will incorporate psycho-educational group discussion of strategies, and individual work through exercises on personal tablet computers and personalized level of difficulty. The CR treatment will take place twice per week for 8 weeks, for a total of 16 sessions. Groups will consist of 4-10 subjects. Subjects will be able to attend MCT after completion of CR if they wish.
16152084|NCT01764555|Drug|acetaminophen 2 g|
16152085|NCT01764542|Procedure|Endoscopy and biopsy|Endoscopy with biopsy of the ileo-anal pouch and the ileo-anal anastomosis Blood samples
16152086|NCT01764477|Drug|PRI-724|"Gemcitabine: 1000 mg/m2 IV over 30 minutes; once weekly dosing; 3 weeks on with 1 week recovery (4 weeks per cycle)
~PRI-724:
~Cohort 1: 320 mg/m2/day; Cohort 2: 640 mg/m2/day; Cohort 3: 905 mg/m2/day; Continuous IV over 24 hours; daily x 7 days; 1 week on with 1 week recovery × 2 (4 weeks per cycle)"
16152087|NCT01764464|Drug|Gralise®|14 day titration (days 1-7 at 600 mg daily Gralise®; days 8-14 at 1200 mg daily Gralise®). 28 day maintenance (1800 mg daily Gralise®). 7 day taper (days 1-4 at 1200 mg daily Gralise®; days 5-7 at 600 mg daily Gralise®).
16152088|NCT01764464|Drug|Placebo|14 day titration (days 1-7 at 600 mg daily placebo; days 8-14 at 1200 mg daily placebo). 28 day maintenance (1800 mg daily placebo). 7 day taper (days 1-4 at 1200 mg daily placebo; days 5-7 at 600 mg daily placebo).
16152089|NCT01764451|Drug|Simvastatin|
16152090|NCT01764438|Procedure|Primovist-enhanced MRI|Performance of Primovist-enhanced MRI in HCC patients with very early or early stage disease, but with no suspicious intrahepatic HCC lesions by liver dynamic CT.
16152091|NCT01764425|Drug|P7435|It is oral DGATI inhibitor with potential in dyslipidemia and T2DM
16152092|NCT01764399|Behavioral|Care4U|
16152093|NCT01764386|Drug|NB|Naltrexone SR 32 mg/Bupropion SR 360 mg (NB) in combination tablets (daily dosage)
16152094|NCT01764386|Behavioral|CLI|The Comprehensive Lifestyle Intervention (CLI) program includes telephone counseling, internet education, goal setting, and online tracking tools.
16152095|NCT01764386|Behavioral|Usual Care|Usual Care is a self-directed lifestyle intervention program
16152096|NCT01764373|Other|Aerobic Exercise|Aerobic exercises in the program include cycle ergometers, treadmills, recumbent steppers and elliptical trainers.
16152097|NCT01764360|Other|KS structured clinical care training|Eight primary care sites in Zimbabwe will receive structured training for diagnosis and treatment of Kaposi sarcoma (KS)
16152098|NCT01764347|Procedure|therapeutic conventional surgery|Undergo robotic radical prostatectomy
16152099|NCT01764347|Procedure|ultrasound-guided prostate biopsy|Undergo MRI-TRUS fusion image-guided prostate biopsy
16152100|NCT01764347|Procedure|magnetic resonance imaging|Undergo MRI-TRUS fusion image-guided prostate biopsy
16152101|NCT01764334|Device|Fractional flow reserve|"Guidewire-based coronary pressure measurement of myocardial FFR can identify obstructive coronary lesions in patients with stable coronary disease, and potentially, medically stabilized patients with recent MI. The FFR index is measured by a conventional coronary wire (0.014) with a pressure sensor on its distal tip during coronary hyperemia induced by intravenous or intracoronary adenosine. The potential diagnostic and prognostic benefit of guidewire-based coronary pressure measurement to inform the management and treatment of patients with recent acute NSTEMI will be assessed."
16152102|NCT01764308|Dietary Supplement|Omega-3|1200mg twice a day for 24 weeks
16152103|NCT01764308|Dietary Supplement|Placebo|4 tablets twice a day for 24 weeks
16152104|NCT01764295|Drug|DWJ1276|
16152105|NCT01764295|Drug|Olmesartan|
16152106|NCT01764295|Drug|Rosuvastatin|
16152107|NCT01764295|Drug|Placebo|
16152108|NCT01764282|Behavioral|comprehensive intervention components|ART promotion, Couple testing and consulting promotion, and Condom use promotion
16152109|NCT01764269|Other|text message surveillance for fever|
16152110|NCT01764256|Biological|P2-VP8 subunit rotavirus vaccine|P2-VP8 subunit rotavirus vaccine was made by inserting a codon optimized synthetic gene for the VP8 region of rotavirus VP4 fused to the P2 T-cell epitope of tetanus toxin into the Pj411 proprietary cloning vector developed by DNA 2.0, Menlo Park, CA. The vector carries a kanamycin resistance gene as a selection marker. The vector was transfected into the BL21 strain of E. coli. The fusion protein was purified from Isopropyl β-D-1-thiogalactopyranoside (IPTG)-induced and physically lysed cultures using standard column chromatographic techniques employing Q-Sepharose and Butyl 650 as resins in addition to ultrafiltration and diafiltration.
16152111|NCT01764256|Other|placebo|Sodium Chloride 0.9%, USP for Injection was used to dilute the active P2-VP8 vaccine to final dosing concentration and was used for the Placebo for the study.
16152112|NCT01764243|Drug|MT-4666|low dose, high dose
16152113|NCT01764243|Drug|Placebo|
16152114|NCT01764230|Drug|triptorelin|Throughout the course of chemotherapy, patients were administered triptorelin (Diphereline SR 3 mg, Ibsen) in the form of i.m. injections, always once a month and simultaneously with the chemotherapy.
16152115|NCT01764204|Drug|Qingkailing Injection|Qingkailing Injection is a kind of natural product injection made from Chinese herbs, which has been used to treat cerebral ischemia for decades in China. The main bioactive ingredients of this injection include Baicalin, Jasminoidin, Ursodeoxycholic Acid, Concha Margaritifera,etc.
16152116|NCT01764191|Other|18F-Fluorodeoxyglucose (18F-FDG) PET/CT|All subjects suspected of cardiac sarcoidosis will receive an intravenous dose of 18F-FDG (determined by weight, but not to exceed 521 MBq). Following an uptake phase of about 60 minutes, each subject will receive a PET/CT scan to evaluate the presence of cardiac sarcoidosis.
16152117|NCT01764178|Drug|Livalo fixed combination drug|Pitavastatin 4mg / Valsartan 160mg
16152118|NCT01764178|Drug|Pitavastatin, Valsartan|Pitavastatin 4mg, Valsartan 160mg
16152119|NCT01764165|Other|Oxygen|oxygen at a rate of 2 L/min will be delivered through a small nasal cannula throughout sleep.
16152120|NCT01764165|Other|High flow of room air|Warm and humidified air at rates of 20 L/min will be delivered through a small nasal cannula throughout sleep
16152121|NCT01764152|Other|nasopharyngeal sample|The nasopharyngeal sample will be used to find the types and subtypes of influenza virus and other respiratory viruses.
16152122|NCT01764139|Procedure|Blood sampling|
16152123|NCT01764126|Drug|Pneumococcal protein vaccine|One dose of 50 µg of each of three proteins with adjuvant (aluminium hydroxide) IM
16152124|NCT01764126|Drug|Pneumococcal protein vaccine|Three doses, 4 weeks apart, of 10 µg of each of three proteins with adjuvant (aluminium hydroxide) IM
16152125|NCT01764126|Drug|Pneumococcal protein vaccine|Three doses, 4 weeks apart, of 25 µg of each of three proteins with adjuvant (aluminium hydroxide) IM
16152126|NCT01764126|Drug|Pneumococcal protein vaccine|Three doses, 4 weeks apart, of 25 µg of each of three proteins without adjuvant IM
16152127|NCT01764126|Drug|Pneumococcal protein vaccine|Three doses, 4 weeks apart, of 50 µg of each of three proteins with adjuvant (aluminium hydroxide) IM
16152128|NCT01764113|Behavioral|Mindful Eating|Subjects and their parents will receive mindful eating based behavioral modification program over multiple sessions
16152129|NCT01764113|Behavioral|Standard dietary counselling|
16152130|NCT01764100|Genetic|Mesenchymal stromal cells|Mesenchymal stromal cells (MSC) intravenous infusion at least two fixed doses of mesenchymal stem cells (1 ± 0.5 x 106/kg recipient body weight for each injection) with 5 to 7 days of interval one from the other, derived from HLA unrelated donor different from the HSC donor (third party donor).
16152161|NCT01763866|Drug|Atorvastatin|Administered orally once a day
16152162|NCT01763866|Drug|Rosuvastatin|Administered orally once a day
16152163|NCT01763866|Drug|Simvastatin|Administered orally once a day
16152164|NCT01763853|Drug|4% albumin|
16152165|NCT01763840|Drug|Contrast enhanced Ultrasound|Ultrasound, then contrast enhanced ultrasound.
16152131|NCT01764087|Drug|KX2-391 and Paclitaxel|"A treatment cycle in phase I will consist of 28 days, according to the following schedule:
~KX2-391 20 mg PO once daily, Weekly paclitaxel 80 mg/m2 given intravenously over 1 hour on day 1, 8, and 15 of a 28 day cycle.
~The trial will initially test the combination of weekly paclitaxel and KX2-391 given PO, once daily , continuously. In case of 2 dose-limiting toxicities (DLT) in the first cohort, this intervention will be terminated
~A treatment cycle in phase II will consist of 28 days, according to the following schedule:
~KX2-391 MTD PO once daily, Weekly paclitaxel 80 mg/m2 given intravenously over 1 hour on day 1, 8, and 15 of a 28 day cycle."
16152132|NCT01764074|Behavioral|Brief Sleep Intervention|Participants will meet with a therapist for three sessions to try to improve sleep problems (hypersomnia or insomnia, depending on the problems the participant has).
16152133|NCT01764048|Drug|Fix protocol|Please see arm description
16152134|NCT01764048|Drug|medications following demand protocol|Please see arm description
16152135|NCT01764035|Behavioral|Body Scan (BS) Meditation Intervention|This intervention consists of 4 individual 60-minute sessions (week 1, 2, 4, and 6) in which participants learn the body scan meditation exercise and practice it at home, daily, lying in bed at their usual bedtime after going to bed (and when waking up at night, unable to go back to sleep). The Body-Scan meditation consists of a 30-minute exercise during which participants are guided to focus their attention on certain parts of their body (e.g. toes, feet). The core skill involves gradually adopting an observant, non-judgmental, and accepting stance towards bodily sensations, including feelings and thoughts.
16152136|NCT01764035|Behavioral|Brief Supportive Psychotherapy (SP)|SP is a common form of non-specific psychotherapy available to patients with bipolar disorder in the community. It focuses on addressing a patient's current concerns, supporting a patient's adaptive coping skills, improving self-esteem, and expressing feelings and the therapeutic alliance. Using a conversational style, SP involves conveying empathy, validation, comforting and supporting patients in coping with distress about current life issues as well as providing encouragement and praise, clarification and opportunity to vent. SP will match BS in length, number of sessions and delivery schedule (four, 60-minute sessions, week 1, 2, 4, 6).
16152137|NCT01764022|Drug|Trastuzumab|Patients will receive 6 courses of trastuzumab in combination with paclitaxel. Trastuzumab will be administered at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations) as 90 min intravenous infusion every 3 weeks (on Day 1 of each cycle).
16152138|NCT01764022|Drug|Paclitaxel|Paclitaxel will be administered at a dose of 175 mg/m2 every 3 weeks (on Day 1 of each course) as 3 hour intravenous infusion (6 courses totally).
16152139|NCT01764009|Biological|naked DNA coding for protein AMEP|injections 28days interval of 3 increasing doses of plasmid with electrotransfer
16152140|NCT01763996|Drug|Febuxostat|Febuxostat capsules
16152141|NCT01763996|Drug|Febuxostat placebo|Febuxostat placebo-matching capsules
16152142|NCT01763983|Behavioral|Cognitive Behavioural Therapy|"CBT will be delivered individually, 1 hour per week, for 12 consecutive weeks. CBT for stress in MS is a structured, short-term, present-oriented therapy with an emphasis on problem-solving and the modification of dysfunctional thinking and behaving. Cognitive strategies include the use of dysfunctional thought records for recording and challenging negative automatic thoughts and the use of behavioural strategies to increase involvement and commitment to personal goals.
~Group therapy following a similar protocol (2 hrs/week) will be offered to those in the waitlist condition after completing the study."
16152143|NCT01763983|Behavioral|Aerobic Exercise|Aerobic exercise will occur three times per week at participating gyms. Duration of the exercise periods will be 15-30 minutes for the first 4 weeks (training stage) and 30-45 minutes for the remaining 8 weeks (improvement stage). The exercise regimen will progress from light-moderate exercise (40-60% intensity) to moderate-high exercise (60-80% intensity), following the same course as the increase in duration.
16152144|NCT01763970|Radiation|SBRT|
16152145|NCT01763957|Behavioral|Paula Method|All subjects allocated to this group will receive one group lesson, 45 minute sessions once a week for twelve weeks. All will be encouraged to practice daily for 15-45 minutes at home. The teachers will be followed a set exercise list.
16152146|NCT01763957|Behavioral|Pelvic Floor Muscle Training (PFMT)|All subjects allocated to this group will receive one group lesson, 45 minute sessions once a week for twelve weeks. All will be encouraged to practice daily for 15-45 minutes at home. The teachers will be followed a set exercise list .
16152147|NCT01763944|Behavioral|Low carbohydrate diet|The Low carbohydrate diet intervention recommends patients to limit carbohydrate intake to less than 20 gram per day.
16152148|NCT01763931|Drug|Digoxin|Digoxin once daily for 2 weeks prior to definitive breast surgery.
16152149|NCT01763918|Biological|Evolocumab|Administered by subcutaneous injection
16152150|NCT01763918|Drug|Placebo|Administered by subcutaneous injection
16152151|NCT01763905|Biological|Evolocumab|Subcutaneous injection
16152152|NCT01763905|Drug|Placebo to Evolocumab|Subcutaneous injection
16152153|NCT01763905|Drug|Ezetimibe|Tablet for oral administration
16152154|NCT01763905|Drug|Placebo to Ezetimibe|Tablet for oral administration
16152155|NCT01763879|Other|The PCV-VCV group|During the PCV period, the inspiratory pressure will be adjusted to deliver a TV of 6 mL/kg (predicted body weight) to the patient's dependent lung. During the VCV period, the patient's dependent lung will be ventilated with a TV of 6 mL/kg (PBW). Whereas FiO2, I: E ratio, PEEP, frequency, Ppk, and a FGF will be maintained as during two-lung ventilation (TLV) and the lumen of the nondependent lung will be left open to air. Dependent lung recruitment maneuvers will be repeated at 30-minute intervals by raising the inspiratory pressure up to 35 cmH2O for 10 seconds.
16152156|NCT01763879|Other|The VCV-PCV group|During the PCV period, the inspiratory pressure will be adjusted to deliver a TV of 6 mL/kg (predicted body weight) to the patient's dependent lung. During the VCV period, the patient's dependent lung will be ventilated with a TV of 6 mL/kg (PBW). Whereas FiO2, I: E ratio, PEEP, frequency, Ppk, and a FGF will be maintained as during two-lung ventilation (TLV) and the lumen of the nondependent lung will be left open to air. Dependent lung recruitment maneuvers will be repeated at 30-minute intervals by raising the inspiratory pressure up to 35 cmH2O for 10 seconds.
16152157|NCT01763866|Biological|Evolocumab|Administered by subcutaneous injection
16152158|NCT01763866|Drug|Ezetimibe|Administered orally once a day
16152159|NCT01763866|Drug|Placebo to Evolocumab|Administered by subcutaneous injection
16152160|NCT01763866|Drug|Placebo to Ezetimibe|Administered orally once a day
16152166|NCT01763827|Biological|Evolocumab|Administered by subcutaneous injection
16152167|NCT01763827|Drug|Ezetimibe|Administered orally once a day
16152168|NCT01763827|Biological|Placebo to Evolocumab|Administered by subcutaneous injection
16152169|NCT01763827|Other|Placebo to Ezetimibe|Administered orally once daily
16152170|NCT01763814|Procedure|Femoral nerve block|A visible or palpable cephalad movement of the patella will confirm needle placement.
16152171|NCT01763814|Procedure|Femoral nerve block non stimulating catheter|A visible or palpable cephalad movement of the patella will confirm needle placement. The catheter will be placed with the nerve stimulator powered off.
16152172|NCT01763814|Procedure|Femoral nerve block stimulating catheter|A visible or palpable cephalad movement of the patella will confirm needle placement. The catheter will be placed with the nerve stimulator powered on.
16152173|NCT01763801|Device|P-Max|tip placement in correspondence to the P-Max on the ECG
16152174|NCT01763801|Device|P-Submax|tip placement in correspondence to the P-Submax on the ECG
16152175|NCT01763788|Drug|Necitumumab|Administered IV
16152176|NCT01763788|Drug|Gemcitabine|Administered IV
16152177|NCT01763788|Drug|Cisplatin|Administered IV
16152178|NCT01763775|Device|Transtek 125X|Measuring weight, total body water, body fat, muscle mass, and bone mass. Measure each participants by Transtek 125X (GBF-1251-B, BF-1255-B, BF-1256-B, GBF-1257-B).
16152179|NCT01763775|Device|Transtek 950D|Measuring weight, total body water, body fat, muscle mass, and bone mass. Measure each participants by Transtek 950D (GBF-950-D).
16152180|NCT01763762|Behavioral|Electrical pudendal nerve stimulation|Four sacral points are selected. The two upper points are located about 1 cm bilateral to the sacrococcygeal joint. On the upper points, a needle of 0.40 Х 100 mm is inserted perpendicularly to a depth of 80 to 90 mm to produce a sensation referred to the urethra or the anus. The locations of the two lower points are about 1 cm bilateral to the tip of the coccyx. On the lower points, a needle of 0.40 Х 100 or 125 mm is inserted obliquely towards the ischiorectal fossa to a depth of 90 to 110 mm to produce a sensation referred to the urethra. After the sensation referred to the above regions is produced, each of two pairs of electrodes from a G6805-2 Multi-Purpose Health Device is connected with the two ipsilaterally inserted needles.
16152181|NCT01763762|Behavioral|PFM training|A nerve function reconstruction treatment system (AM1000B; Shenzhen Creative Industry Co.Ltd, China) is used for EMG-biofeedback assisted PFMT.
16152182|NCT01763762|Behavioral|Transvaginal ES|A neuromuscular stimulation therapy system (PHENIX USB 4，Electronic Concept Lignon Innovation, France) is used for TES
16152183|NCT01763749|Drug|Closone|Closone 75mg/100mg, 4weeks, PO
16152184|NCT01763749|Drug|Plavix with Astrix|Plavix 75mg with Astrix 100mg, 4weeks, PO
16152185|NCT01763736|Behavioral|Music|playlist per patient preference
16152186|NCT01763723|Device|IPL-home use device|A light based home use device for hair removal
16152187|NCT01763710|Drug|Paclitaxel 80 mg/m2|Paclitaxel 80 mg/m2 days 1, 8 and 15
16152188|NCT01763710|Drug|Nab-paclitaxel 100 mg/m2 days 1, 8 and 15|Nab-paclitaxel 100 mg/m2 days 1, 8 and 15
16152189|NCT01763710|Drug|Nab-paclitaxel 150 mg/m2 days 1, 8 and 15|Nab-paclitaxel 150 mg/m2 days 1, 8 and 15
16152190|NCT01763710|Drug|Nab-paclitaxel 150 mg/m2 days 1 and 15|Nab-paclitaxel 150 mg/m2 days 1 and 15
16152191|NCT01763697|Behavioral|taste acuity assessment|Quantitative measurement of for tasting detection and recognition thresholds, magnitude of perception and hedonic response.
16152192|NCT01763697|Behavioral|Recorded meal|
16152193|NCT01763684|Device|Signature Custom Guides|Signature Custom Guides: Signature Custom Guides are intended to be used as a surgical instrument to assist in the positioning of knee replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans (preoperative MRI).
16152194|NCT01763684|Procedure|Conventional Instrumentation|Traditional partial knee arthroplasty without the use of Signature technology.
16152195|NCT01763671|Drug|Docetaxel|75 mg/m² IV on day one of 21 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
16152196|NCT01763671|Drug|Paclitaxel|90 mg/m² IV on day 1, 8 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
16152197|NCT01763671|Drug|Bevacizumab|10 mg/kg IV on day 1 and 15 of 28 days cycle Number of Cycles: until progression or unacceptable toxicity develops.
16152198|NCT01763658|Drug|Antox tablets(Mepaco)|effect of antioxidant on disease outcome
16152199|NCT01763658|Other|drug therapy for ITP|drugs will be selected according to ASH,2011 guidelines
16152200|NCT01763645|Drug|Bevacizumab|Patients will receive 6 courses of bevacizumab in combination with carboplatin and paclitaxel. Bevacizumab will be administered at a dose of 15 mg/kg as 90 min intravenous infusion every 3 weeks (on Day 1 of each cycle).
16152201|NCT01763645|Drug|Paclitaxel|Paclitaxel will be administered at a dose of 175 mg/m2 as 3 hour intravenous infusion on Day 1 of each 3-week course (6 courses totally)
16152202|NCT01763645|Drug|Carboplatin|Carboplatin will be administered (AUC 6 mg/ml×min) as 15 - 30 min intravenous infusion just after paclitaxel on Day 1 of each 3-week course (6 courses totally).
16152203|NCT01763632|Device|Transcutaneous bilirubinometry|Device: JM-103 (Minolta, Osaka, Japan, jaundice assessment) Procedure: Transcutaneous bilirubinometry (TcB)
16152204|NCT01763619|Device|Freedom Cervical Disc|
16152205|NCT01763606|Drug|Enoxaparin|Patients will be receive 6 months of subcutaneous enoxaparin (1 mg/kg BID with a maximum starting dose of 100 mg BID. Patients who weigh more than 100 kg will start at a dose of 100 mg BID; their subsequent dosing will be guided by hematology and may change.
16152206|NCT01763606|Drug|Aspirin|Patients will receive 6 months of oral aspirin (81 mg per day unless a higher dose is preferred by study physicians although the maximum acceptable dose will be 325 mg per day).
16152207|NCT01763580|Drug|Tacrolimus|Oral
16152208|NCT01763580|Drug|Prednisolone|Oral
16152209|NCT01763554|Drug|Lu-177 DOTA-TATE|The regimen used for therapy for patients treated under SAP was a standard dose of 5.55 GBq Lu-177 DOTA-TATE every 10-12 weeks for 4 treatments, then every 6 months as maintenance treatment.
16152210|NCT01763541|Drug|leuprolide acetate|Given to both arms to induce hypogonadism
16152211|NCT01763541|Drug|Anastrozole|Given to men to prevent conversion of administered testosterone to estradiol.
16152212|NCT01763528|Other|nutrition intervention|high protein diet
16152213|NCT01763515|Procedure|Laterally wedged insoles|Patients will use laterally wedged insoles with 5o tilt toward medial side and made of ethylene vinyl acetate coated with leather. The medial thickness is 4 mm with lateral thickness of 10 mm.
16152214|NCT01763502|Other|FOOD|The food transfers consist of multiple-micronutrient-fortified corn soy blend (CSB), oil, and sugar, totaling approximately 1200 calories per day per child and including 99% of iron requirements.
16152215|NCT01763502|Other|CASH|Cash transfers equal the estimated value of the food basket if purchased in the market.
16152216|NCT01763489|Behavioral|Applicability Assessment|assess the applicability of a trial using the ASSIST tool or the synopsis
16152217|NCT01763476|Procedure|paclitaxel-coated balloon angioplasty|plain balloon angioplasty followed by paclitaxel-coated balloon angioplasty of the target lesion
16152218|NCT01763476|Procedure|atherectomy|atherectomy (TurboHawk, ev3) followed by paclitaxel-coated balloon angioplasty of the target lesion
16152219|NCT01763463|Drug|New users of ADVAIR DISKUS, ADVAIR HFA (ICS) - containing medications|Patients will be considered a new user of ICS-containing medications if they had not received a prescription for an ICS-containing medication in the year prior to cohort entry. ICS-containing medications could include ICS and ICS/LABA fixed dose combinations combinations. Patients could not use LABD (long-acting beta-agonists and long-acting antimuscarinics) in the year prior or initiate triple therapy (e.g., ICS/LABA/LAMA) as their new user prescription.
16152220|NCT01763463|Drug|New users of FLOVENT DISKUS, FLVENT HFA (long-acting bronchodilators (LABD))|Patients will be considered a new user of LABD medications (long-acting beta-agonists or long-acting antimuscarinics but not both) if they had not received a prescription for an LABD medication in the year prior to cohort entry. Patients could not use ICS-containing medications in the year prior to their new use of LABD or initiate triple therapy (e.g., ICS/LABA/LAMA) as their new user prescription.
16152221|NCT01763450|Drug|bevacizumab plus chemotherapy|"Bevacizumab:
~7.5mg/kg, iv, on day 1 of each 21 day cycle or 5mg/kg, iv, on day 1 of each 14 day cycle;
~Oxaliplatin+capecitabine(XELOX):( The total dose not less than 70% of the recommended dose of this standard) Oxaliplatin: 130mg/m2,d1; capecitabine: 850-1,000mg/m2，d1-d14, bid，each 21 day cycle;
~Oxaliplatin+5-Fluorouracil+ Levomisole（FOLFOX）:
~Oxaliplatin: 85mg/m2,iv for 2 hours ,d1; Levomisole（LV）: 400mg/m2,iv for 2 hours,d1; 5-Fluorouracil（5-FU） :400mg/m2 iv,d1,then 1200mg/m2/d ×2d continuous intravenous infusion(volume dose:2400mg/m2,iv for 46-48 hours ) each 14 day cycle;"
16152222|NCT01763437|Drug|Tetracycline|Chalazia randomized to the treatment arm will be injected with 0.05 mL of 2% tetracycline solution.
16152223|NCT01763424|Drug|Calcipotriol plus Nicotinamide|Patients applied calcipotriol 0.005% and nicotinamide 4% in combination (By LEO Pharmaceuticals, Ballerup, Denmark) for lesions of one side of the body. The patients uses the medications twice daily (in the morning and before sleeping) for 12 weeks; the total doses of medication used not more than 100 gram per week.
16152224|NCT01763424|Drug|Calcipotriol|Patients applied calcipotriol 0.005% (By LEO Pharmaceuticals, Ballerup, Denmark) for lesions of the other side of the body. The patients uses the medications twice daily (in the morning and before sleeping) for 12 weeks; the total doses of medication used not more than 100 gram per week.
16152225|NCT01763385|Drug|Erlotinib|
16152226|NCT01763385|Radiation|concurrent brain radiotherapy|
16152227|NCT01763385|Radiation|secondary brain radiotherapy|
16152228|NCT01763346|Drug|Metformin|metformin 1000 mg bid
16152229|NCT01763346|Device|gastric banding|LAP-BAND
16152230|NCT01763333|Drug|BI 1026706 Placebo|Placebo to BI 1026706
16152231|NCT01763333|Drug|BI 1026706|different dose formulations
16152232|NCT01763320|Procedure|Intracranial stenting group|all the participants in this group will be performed with intracranial stenting
16152233|NCT01763320|Drug|medical group|all the participants in this group will be given medical therapy including aspirin 100mg + clopidogrel 75mg per day for 90 consecutive days and clopidogrel 75mg per day thereafter
16152234|NCT01763307|Drug|RECONVAL CREAM|
16152235|NCT01763307|Drug|PLACEBO|
16152236|NCT01763294|Device|Nicolet Endeavor CR: 30min|Transcranial direct current stimulation (tDCS) is a safe, non-invasive method that modulates cortical excitability. In direct current polarization, the cerebral cortex is stimulated through a weak constant electric current in a noninvasive and painless manner. This weak current induces focal changes of cortical excitability increase or decrease depending on the electrode polarity- that last beyond the period of stimulation.
16152237|NCT01763294|Device|Nicolet Endeavor CR: 60min|Transcranial direct current stimulation (tDCS) is a safe, non-invasive method that modulates cortical excitability. In direct current polarization, the cerebral cortex is stimulated through a weak constant electric current in a noninvasive and painless manner. This weak current induces focal changes of cortical excitability increase or decrease depending on the electrode polarity- that last beyond the period of stimulation.
16152238|NCT01763294|Device|Nicolet Endeavor CR: 30min for 3 days|Transcranial direct current stimulation (tDCS) is a safe, non-invasive method that modulates cortical excitability. In direct current polarization, the cerebral cortex is stimulated through a weak constant electric current in a noninvasive and painless manner. This weak current induces focal changes of cortical excitability increase or decrease depending on the electrode polarity- that last beyond the period of stimulation.
16152239|NCT01763294|Device|Nicolet Endeavor CR: 30min for 5 days|Transcranial direct current stimulation (tDCS) is a safe, non-invasive method that modulates cortical excitability. In direct current polarization, the cerebral cortex is stimulated through a weak constant electric current in a noninvasive and painless manner. This weak current induces focal changes of cortical excitability increase or decrease depending on the electrode polarity- that last beyond the period of stimulation.
16152240|NCT01763294|Device|Nicolet Endeavor CR: Placebo|The same procedures just that in this case the machine produces only a 60 second stimulus at the beginning so the patient can feel the initial electric stimulus.
16152241|NCT01763281|Drug|CRH|
16152242|NCT01763281|Drug|Placebo|
16152243|NCT01763268|Biological|Trivivac vaccine|Trivalent MMR vaccine
16152244|NCT01763255|Biological|stem cell intrathecal injection|Intrathecal injection of Bone marrow derived CD133 cells
16152245|NCT01763242|Other|EMAN|See details on ESA Synchronization and Dosing in Detailed Description Above
16152246|NCT01763229|Procedure|transthoracic echocardiography|
16152247|NCT01763216|Other|Road Tour|Training dosage includes 10 hours at baseline, four hours of booster training at month five, and four hours of booster training at month 11.
16152248|NCT01763216|Other|Boatload of Crosswords|Training dosage includes 10 hours at baseline, four hours of booster training at month five, and four hours of booster training at month 11.
16152249|NCT01763203|Behavioral|Care Management+Community Health Worker|Over a period of a year subjects randomized into the Intervention arm of the study will receive support from a Care Manager. Subjects will also participate in educational group sessions on chronic disease self-management and have home visits by a Community Health Worker who will use mobile health technology.
16152250|NCT01763203|Behavioral|Usual Care|Subjects randomized into the Usual Care arm will receive educational materials about stroke distributed to the Intervention patients and will receive their post-stroke care as usual.
16152251|NCT01763190|Drug|SAR302503|"Pharmaceutical form:capsule
~Route of administration: oral"
16152252|NCT01763177|Other|Oxygen|Oxygen mask 40% 8 LPM for 30 minutes
16152253|NCT01763164|Drug|MEK162|MEK162 will be administered as a fixed dose of 45 mg (3 x 15 mg tablets) BID, with a glass of water and taken with or without food.
16152254|NCT01763164|Drug|Dacarbazine|Patients randomized to dacarbazine will receive an IV infusion of dacarbazine 1000 mg/m2 over the course of 1 hour on day 1 and then every three weeks.
16152255|NCT01763151|Device|toric IOL|implantation of an aspheric, toric, acrylic IOL during cataract surgery
16152256|NCT01763151|Procedure|IOL combined with opposite clear corneal incision (OCCI)|aspherical, acrylic IOL with opposite clear corneal incision during cataract surgery
16152257|NCT01763138|Behavioral|oral health education|oral health education in the form of a pictorial pamphlet.
16152258|NCT01763138|Behavioral|reminder phone call|a reminder phone call on oral health instructions would be given to mothers after every one month over a period of three months.
16152259|NCT01763125|Other|Blood collection|Blood sample is collected during routine blood collection by a medical doctor. No more than 60ml (max.) at one timepoint.
16152260|NCT01763112|Device|Exercise Group Galileo PAH|The intervention/exercise group will do whole body vibration training on 4 days a week for 60 minutes over 4 weeks
16152261|NCT01763099|Biological|Mesenchymal stem cells|Mesenchymal stem cells will be intravenously infused via a central venous catheter(at a dose of 1×10^6 cells/kg, over 15 min) in day 1 and day 15 of the cycle. If the NEU and PLT levels do not attain the completely response(CR)standards after this cycle, mesenchymal stem cells combined with cord blood will be given. If the NEU and PLT levels attain the completely response(CR)or partly response(PR) standards after this cycle, another cycle with the same strategy will be given.
16152262|NCT01763099|Biological|Mesenchymal stem cells and cord blood|Mesenchymal stem cells will be given (at a dose of 1×10^6 cells/kg,intravenously infused via a central venous catheter)on day 1.day 15, day 29 and day 43 of the cycle. Cord blood will be given intravenously infused via a central venous catheter on day 2 of the cycle.
16152263|NCT01763086|Biological|Mesenchymal stem cells|Mesenchymal stem cells will be intravenously infused via a central venous catheter,at a dose of 1×10^6 cells/kg, over 15 min. The vital signs of all patients will be closely monitored during and for 24h after MSCs administration. If the NEU and PLT levels do not attain the completely response(CR)standards within 14d, a second course of MSCs treatment will be given.
16152264|NCT01763060|Radiation|CT scan|
16152265|NCT01763060|Behavioral|Cognitive function|
16152266|NCT01763060|Radiation|MRI|
16152267|NCT01763047|Device|etafilcon A|To be worn in a daily wear modality for a minimum of 6 hours per day.
16152268|NCT01763047|Device|lotrafilcon B|Lenses will be worn in a reuseable modality; cleaned and disinfected each night.
16152269|NCT01763034|Procedure|limb ischemic preconditioning|use a simple blood pressure cuff inflate for 5 minutes and deflate for 5 minutes alternately in each arms total = 3 cycle in each arm
16152270|NCT01763021|Drug|PCI-32765|PCI-32765 will be administered as a single oral dose of PCI-32765 560 mg on Day 1 and Day 11
16152271|NCT01763021|Drug|Rifampin|Rifampin 600 mg (2 X 300 mg) daily dose will be administered orally from Day 4 to Day 13 and on Day 11 along with PCI-32765.
16152272|NCT01763008|Drug|No intervention|This is an observational study. Doripenem will be administered as per the recommended dose, ie, 500 mg, intravenously (ie, in the vein), for every 8 hours. Duration of treatment with doripenem: for nosocomial pneumonia including ventilator-associated pneumonia patients: 7 to 14 days; for complicated intra-abdominal infection patients: 5 to 14 days; for complicated urinary tract infection, including pyelonephritis (bacterial infection of the kidneys) patients: 10 days.
16152273|NCT01762995|Drug|Dolutegravir 50 mg|One tablet ( 50 mg) will be administered orally as a single dose in each period per the random code
16152274|NCT01762995|Drug|Calcium Carbonate 1200 mg|Two tablets (2 X 600 mg) will be administered orally as a single dose in three out of four periods to Cohort 1 only per the random code. Calcium carbonate will be given in fasted state, fed state and 2 hours before dolutegravir administration.
16152275|NCT01762995|Drug|Ferrous Fumarate 324 mg|One tablet (324 mg) will be administered orally as a single dose in three out of four periods to Cohort 2 only per the random code. Ferrous fumarate will be given in fasted state, fed state and 2 hours before dolutegravir administration.
16152276|NCT01762982|Drug|0.13% Benzalkonium Chloride|Finn Chamber filled with benzalkonium chloride (0.13%) disinfectant spray water solution
16152277|NCT01762982|Drug|SLS Solution|Finn Chamber filled with SLS (0.3% w/v) water solution
16152278|NCT01762982|Drug|Normal Saline Water|Finn Chamber filled with Normal Saline water (0.9% w/v)
16152279|NCT01762982|Other|Empty Finn Chamber|Empty Finn Chamber
16152280|NCT01762969|Other|Treatment modification based on molecular response at 3 months|Patients will be treated with imatinib upon diagnosis of CML. Molecular response will be assessed at 3 months of therapy. Based on molecular response imatinib will be continued or changed to another TKI
16152312|NCT01762787|Drug|Placebo to aspirin|0mg three times daily orally over a course of 4 days (starting Day -3) Part 2 only
16152313|NCT01762787|Drug|Placebo to prednisolone|0mg orally once a day over a course of 4 days (starting Day -3) Part 2 only
16152357|NCT01762423|Device|Active Device (IVIVI SofPulse)|
16152358|NCT01762423|Device|Sham Device|
16152409|NCT01762046|Other|Oral Glucose Tolerance Test|
16152410|NCT01762033|Drug|ASONEP|Intravenous infusion
16152281|NCT01762956|Other|Pelvic floor muscles training|The supervised muscle training will be conducted once a week with 45 minutes each session during the RT (12 weeks). In addition to the supervised sessions, patients will be instructed about the practice of home exercises and receive a guidance booklet of exercises with explanations of each exercise to be performed. These exercises must be performed daily and should be written down in the worksheet when they are performed. After this 3 month period, the patients will be encouraged to continue the exercise protocol at home without supervision. They must attend monthly to monitor adherence to home exercises.
16152282|NCT01762943|Drug|Leuprolide Acetate|All subjects will receive one IM injection (3.75 mg) each month for four months.
16152283|NCT01762943|Drug|Micronized estradiol|All participants will receive micronized estradiol daily for eight weeks. Estradiol will be started at a dose of 4 mg/day and increased progressively up to 10 mg/day.
16152284|NCT01762943|Drug|Progesterone|All subjects will receive micronized progesterone daily for eight weeks. Progesterone will be started at 400 mg/day and increased progressively up to 800 mg/day.
16152285|NCT01762930|Drug|Shanchol|Each dose of the vaccine contains inactivated whole cell, heat killed and formalin killed bacteria measured as ELISA Units (EU) of lipopolysaccharide (LPS). It contains formalin-killed V. cholerae Inaba, El Tor biotype (strain Phil 6973; 600 EU); heat-killed V. cholerae Ogawa classical biotype (Cairo 50; 300 EU); formalin killed V. cholerae Ogawa classical biotype (Cairo 50; 300 EU); LPS of heat-killed V. cholerae Inaba, classical biotype (Cairo 48; 300 EU); and formalin killed V. cholerae O139 (4260B; 600 EU).
16152286|NCT01762904|Other|Bacterial culture of the prepared skin's areas with two antiseptics and two controls|Cultures will be taken with a scrub-cup of 5 cm2 of internal area pressed over the skin previously prepared with the substances, then it added a 3 mL of culture broth (D/E Neutralizing Broth, Difco TM) containing a neutralizing agent as washing solution. The skin will scrub with a sterile rubber policeman for 1 minute and the procedure will be conducted once again. Both aliquots will gather together in a sterile tube, and a sample of 50 microliters will spread in a plate containing a neutralizing agar (D/E neutralizing Agar, Difco TM) and incubate at 35°C for 24 hrs. After incubation, the colonies will be counted.
16152287|NCT01762904|Other|Preparing skin's areas to be tested with two antiseptics and two controls|All volunteers will be provided with a neutral soap and shampoo without antiseptics for use during a period of two weeks (phase of stabilization of the skin flora). Two antiseptics (2% chlorhexidine gluconate in 70% isopropyl alcohol and 1% triclosan in 70% isopropyl alcohol) and two controls (Scrub the skin without prior application of any substance and Deionized water redistilled) will be tested as skin antiseptics. The intervention consists of preparing four skin's areas with antiseptics and controls, two in each arm of the volunteer. These ones were approximately 25 cm2 on the forearm for each antiseptic or control. The substances will be applied in an outward circular motion using a sterile swab soaked with the solutions. The solution will remain on the skin for 60 seconds, 3 hours and 24 hours before the bacterial culture will be conducted. For the control where it will be does not apply any substance, the scrub starts immediately.
16152288|NCT01762891|Drug|Celecoxib|celecoxib 200mg/day by oral rout during 15 days followed by the administration of rofecoxib 25mg/day, acetaminophen 3g/day and placebo during 15 days each drug.
16152289|NCT01762891|Drug|Acetaminophen|Acetaminophen 3g/ was given during 15 days by oral rout following one of the other interventions or as the final intervention.
16152290|NCT01762891|Drug|Rofecoxib|Rofecoxib 25mg/day was given by oral rout during 15 days following one or more interventions or as the final intervention.
16152291|NCT01762891|Drug|placebo|Placebo pills were given during 15 days by oral rout as one of the four interventions.
16152292|NCT01762878|Drug|GSK2269557|Dry powder for oral inhalation (100 and 500 mcg /blister) once daily using DIKUS device. The doses of GSK2269557 planned for Part A are: 100 mcg, 500 mcg and 3000 mcg
16152293|NCT01762878|Drug|Placebo|Dry powder for oral inhalation once daily using DIKUS device
16152294|NCT01762852|Drug|Belimumab 10 mg|Belimumab is Lyophilised powder for reconstitution in 4.8 mL sterile water for injection (SWFI) and diluted in normal saline (250 mL). 400 mg per vial plus excipients (citric acid/sodium citrate/sucrose/polysorbate). Belimumab 10 mg/kg intravenous infusion (will last for 1 hr) on Day 0, Week 2, Week 4, then every 4 weeks for up to 100 weeks
16152295|NCT01762852|Drug|Placebo|Normal saline solution (sodium chloride 154 mmol/L). Intravenous infusion (will last for 1 hr) on Day 0, Week 2, Week 4, then every 4 weeks for up to 100 weeks
16152296|NCT01762839|Drug|Single-Dose IV Oritavancin Diphosphate|Intravenous oritavancin will be administered via two dedicated, peripheral venous lines one in each arm. The infusion will last approximately 3 hours.
16152297|NCT01762839|Drug|Placebo|IV placebo will be administered via two dedicated, peripheral venous lines one in each arm. The infusion will last approximately 3 hours.
16152298|NCT01762839|Drug|Moxifloxacin|Subjects randomized to the open label Moxifloxacin treatment arm will only receive a 400 mg moxifloxacin tablet and will not receive a placebo infusion.
16152299|NCT01762826|Dietary Supplement|Myo-inositol|Dietary control plus Myo-inositol
16152300|NCT01762826|Dietary Supplement|D-chiro-inositol|Dietary control plus D-Chiro-Inositol supplementation
16152301|NCT01762826|Dietary Supplement|D-Chiro / Myo-inositol|Dietary control Supplementation with myo and d-chiro inositol
16152302|NCT01762826|Dietary Supplement|Placebo|Dietary control plus folic acid 400 mcg daily
16152303|NCT01762813|Procedure|open and laparoscopic surgery|Curative surgery for either primary (colorectal cancer, crc) or metastatic CRC (liver surgery)
16152304|NCT01762800|Drug|fluticasone propionate/salmeterol 50/250mcg|Active, 50/250mcg, Twice daily (morning and evening)
16152305|NCT01762800|Drug|fluticasone propionate/salmeterol placebo|Placebo, Twice daily (morning and evening)
16152306|NCT01762800|Drug|tiotropium bromide 18mcg|Active, 18mcg, Once daily(morning)
16152307|NCT01762800|Drug|tiotropium bromide placebo|Placebo, Once daily(morning)
16152308|NCT01762800|Drug|fluticasone propionate/salmeterol 50/250mcg and tiotropium 18mcg|Active. The randomized treatment may be switched to TRIPLE therapy when COPD symptoms are uncontrolled or the subject is not satisfied with the randomized treatment at each scheduled or unscheduled visit.
16152309|NCT01762787|Drug|Cantharidin solution|5 microlitres of 0.025 to 0.5% topically on Day 1, 2 and 3
16152310|NCT01762787|Drug|Aspirin|300mg three times daily orally over a course of 4 days (starting Day -3) Part 2 only
16152311|NCT01762787|Drug|Prednisolone|30mg orally once a day over a course of 4 days (starting Day -3) Part 2 only
16152314|NCT01762774|Drug|GSK2256294|GSK2256294 capsules will be administered as once daily as single dose 2 mg, 6 mg, 15 mg in Cohort 1 and 15 mg, 40 mg, 100 mg in Cohort 2. GSK2256294 capsules will be administered once or twice daily (cohorts 3 and 4) at the dose determined from the data from Cohort 1 and 2. GSK2256294 capsules will be available in 1, 5, 25 mg dose strength.
16152315|NCT01762774|Drug|Placebo|Matching placebo will be administered once daily (cohorts 1 and 2); and once or twice daily (cohorts 3 and 4).
16152316|NCT01762761|Drug|eltrombopag|TPO-R agonist
16152317|NCT01762761|Drug|placebo|placebo
16152318|NCT01762748|Drug|Saccharomyces boulardii|Oral capsule with 200 mg lyophilized S. boulardii-17 (about 4x108 cells), 6 mg sucrose and 2.4 mg magnesium stearate (Floratil®).
16152319|NCT01762735|Other|Air insufflation|Air is inflated into the bowel to help searching the cavity while advancing the colonoscope until reaching the cecum.
16152320|NCT01762735|Other|Water injection|Water was injected through the working channel instead of air to follow the intestinal cavity until reaching the caecum.
16152321|NCT01762722|Device|Reduction of inspired oxygen|Reduction in blood oxygen saturation by sequential reduction in inspired gas composition. Steps are of 6 minutes duration with reduction in pulse oximeter oxygen saturation from 100 to 70%.
16152322|NCT01762709|Procedure|The VT 4 ml/kg group|the dependent lung will be ventilated with a TV of 4 mL/kg (predicted body weight), respectively, whereas FiO2, I: E ratio, PEEP, frequency, Ppk, and a FGF will be maintained as during two-lung ventilation (TLV) and the lumen of the nondependent lung will be left open to air. Dependent lung recruitment maneuvers will be repeated at 30-minute intervals by raising the inspiratory pressure up to 35 cmH2O for 10 seconds.
16152323|NCT01762709|Procedure|The VT 6 ml/kg group|the dependent lung will be ventilated with a TV of 6 mL/kg (predicted body weight), respectively, whereas FiO2, I: E ratio, PEEP, frequency, Ppk, and a FGF will be maintained as during two-lung ventilation (TLV) and the lumen of the nondependent lung will be left open to air. Dependent lung recruitment maneuvers will be repeated at 30-minute intervals by raising the inspiratory pressure up to 35 cmH2O for 10 seconds.
16152324|NCT01762709|Procedure|The VT 8 ml/kg group|the dependent lung will be ventilated with a TV of 8 mL/kg (predicted body weight), respectively, whereas FiO2, I: E ratio, PEEP, frequency, Ppk, and a FGF will be maintained as during two-lung ventilation (TLV) and the lumen of the nondependent lung will be left open to air. Dependent lung recruitment maneuvers will be repeated at 30-minute intervals by raising the inspiratory pressure up to 35 cmH2O for 10 seconds.
16152325|NCT01762696|Behavioral|MET|Motivational Enhancement Therapy only
16152326|NCT01762696|Behavioral|MOMENT|The full MOMENT intervention: Motivational Enhancement Therapy + momentary and daily mobile self-monitoring + motivational feedback messages prompting participants to consider their individualized coping strategies to avoid using marijuana
16152327|NCT01762683|Other|Myometrium biopsy and blood samples|"The biopsy of myometrium is specially realised for the study in surgical unit after the release of the child, in women with normal pregnancy but necessitating a caesarean.
~The blood samples are realised, specially for the study, either during the medical exam before the ceasarean or specifically for the study."
16152328|NCT01762670|Drug|GoldenCare|Copper intravaginal device to treat bacterial vaginosis.
16152329|NCT01762670|Drug|Metronidazole|500 mg twice daily for 7 days
16152330|NCT01762657|Drug|Oral Cyclosporine and Oral Lansoprazole|Oral Cyclosporine A dosed at 7.5 mg/kg/day and Oral Lansoprazole dosed at 30 mg in two divided dosages to subjects ages 8-15 and 60 60 mg in divided dosages to subjects ages 16-60. The Cyclosporine A and Lansoprazole may be given as an oral tablet/capsule or oral suspension.
16152331|NCT01762657|Drug|Placebos|Two oral placebos are given at breakfast and dinner. The placebos may be given as an oral tablets/capsules or oral suspensions.
16152332|NCT01762644|Drug|Oral Cyclosporine and Oral Omeprazole|
16152333|NCT01762644|Drug|Oral Omeprazole|
16152334|NCT01762618|Behavioral|Cognitive Behavioral Therapy Group|Therapy Groups
16152335|NCT01762605|Other|Supportive Care|
16152336|NCT01762605|Procedure|Cast|
16152337|NCT01762592|Drug|Iodine (124I) Girentuximab|i.v.
16152338|NCT01762579|Dietary Supplement|wheat flour|wheat flour is administered three times per day for 15 days
16152339|NCT01762579|Dietary Supplement|Xylose|Xylose will be administered three times per day for 15 days
16152340|NCT01762566|Dietary Supplement|wheat|wheat is administered blindly versus placebo in capsules once
16152341|NCT01762566|Dietary Supplement|xylose|placebo (xylose) will be administered blindly versus wheat in a capsule once
16152342|NCT01762553|Behavioral|The TEA intervention|TEA Gathering is a small group training session for PLH and their family members to deal with HIV-related challenges at individual level; TEA Time is home based family activities for PLHs and their family members to interact with their children after each TEA Gathering to promote family positive interaction; TEA Garden is the community events that built social integration for HIV affected families to live a healthy social life and to build sustained, supportive relationships in their communities. There will be reunions once a month for 12 months after the completion of the TEA intervention.
16152343|NCT01762540|Drug|Glucocorticoids|Prednisolone 37.5 mg x1 for 5 days
16152344|NCT01762540|Drug|Calcium Supplement|Placebo
16152345|NCT01762527|Radiation|Adaptive Radiotherapy|CTCAE scoring baseline, every 2'nd week during RT, 2 weeks, 3, 12 and 24 month after RT cineMR (time resolved MR) baseline and weekly during RT for intra fractional motion
16152346|NCT01762514|Drug|Amifostine every-other-day regimen|Amifostine 400mg/d, every-other-day regimen from Monday to Friday, every week repetition during radiotherapy
16152347|NCT01762514|Drug|Amifostine everyday regimen|Amifostine 400mg/d, everyday regimen from Monday to Friday, every week repetition during radiotherapy
16152348|NCT01762501|Drug|Azilsartan|Azilsartan 20mg/day
16152349|NCT01762501|Drug|Amlodipine|Amlodipine 5mg/day
16152350|NCT01762488|Procedure|Ablation of the renal arteries|Catheter-based renal denervation by applying low power radiofrequency to the renal artery using the EnligHTN Catheter, introduced by femoral artery access.
16152351|NCT01762488|Procedure|Renal angiography|Renal angiography by femoral access
16152352|NCT01762475|Drug|Sildenafil|
16152353|NCT01762462|Drug|SAR302503|"Pharmaceutical form:capsule
~Route of administration: oral"
16152354|NCT01762449|Other|Followup survey|
16152355|NCT01762436|Drug|bisoprolol|
16152356|NCT01762436|Drug|atenolol|
16152359|NCT01762410|Drug|P7170|Patients will receive study drug on a daily basis for twenty-one days according to the dose and schedule specified for a particular cohort of therapy. This 21 day administration will define a treatment cycle. Patients may receive consecutive treatment cycles until evidence of disease progression, intolerance of therapy, death or withdrawal from the protocol as specified.
16152360|NCT01762397|Drug|PMK-S005|
16152361|NCT01762384|Procedure|LSC|subjects of this group are submitted to surgical treatment of laparoscopic sacral colpopexy.
16152362|NCT01762384|Procedure|modified PFRS|subjects of this group are submitted to modified pelvic floor reconstructive surgery with mesh.
16152363|NCT01762384|Device|"Gynemesh"|Both surgeries will be conducted using mesh constructed from polypropylene mesh.
16152364|NCT01762371|Other|Khalifa Therapy|One hour of Khalifa's therapy which is specially applied pressure to the skin.
16152365|NCT01762358|Other|Khalifa's therapy|One hour of Khalifa's therapy which is specially applied pressure to the skin
16152366|NCT01762358|Other|Physiotherapy|Twelve times standardized Physiotherapy
16152367|NCT01762345|Device|pessary (disposable intra-vaginal device)|pessary device(disposable intra-vaginal device)manufactured by Procter & Gamble
16152368|NCT01762332|Drug|Base level of remifentanil effect side concentration: 2ng/ml|constant remifentanil level of 2ng/ml administered using Target Control Infusion pumps.
16152369|NCT01762332|Drug|Base level of remifentanil effect side concentration: 4ng/ml|constant remifentanil level of 4ng/ml administered using Target Control Infusion pumps.
16152370|NCT01762332|Other|chronic beta-blocker treatment|Patients from the chronic beta-blocker treatment group will not be randomized, and will all be allocated to the high opioid level group.
16152371|NCT01762319|Drug|Misoprostol|
16152372|NCT01762319|Drug|Vitamin B6|
16152373|NCT01762306|Drug|Diclofenac Potassium|
16152374|NCT01762306|Drug|Folic Acid|
16152375|NCT01762293|Drug|Famitinib|Famitinib 25 mg p.o. qd
16152376|NCT01762293|Other|placebo|p.o. qd
16152377|NCT01762280|Drug|Famitinib Malate Capsule|
16152378|NCT01762267|Other|nutrition intervention|DASH diet control diet
16152379|NCT01762254|Procedure|incisionless laparoscopic colectomy|Arm 1:Incisionless Laparoscopic Colectomy Laparoscopic colectomy is being performed in the same manner as conventional laparoscopic colectomy, except that at the end of procedure, the TEO device with the outer diameter of 4cm is inserted into the anus for the delivery of specimen and insertion of anvil instead of creating a small wound as in the conventional laparoscopic colectomy. Finally, intra-corporeal anastomosis is performed in the same manner with the TEO device removed.
16152380|NCT01762254|Procedure|conventional laparoscopic colectomy|Arm 2: Conventional Laparoscopic colectomy The operation is completed by laparoscopic instruments using video laparoscopy. At the end of the procedure, pneumoperitoneum is abolished and a small wound was created for the delivery of bowel and insertion of anvil of the circular stapler. Finally, pneumoperitoneum is re-created for intra-corporeal anastomosis
16152381|NCT01762241|Behavioral|Home based training using the Xbox Kinect system|Home based training 3 times a week for 12 weeks using the Xbox Kinect system
16152382|NCT01762228|Device|Transcutaneous electrical stimulation|Using a device which gives electrical stimulation, electrodes will be placed transcutaneously in oropharyngeal muscles of patients giving a sensorial stimuli during one hour for 5 days/week during 2 weeks of treatment.
16152383|NCT01762228|Dietary Supplement|TRPV1 agonist|Patient will be given a TRPV1 agonist natural product (which contains capsaicin) before every meal, during one hour for 5 days/week during 2 weeks of treatment.
16152384|NCT01762215|Behavioral|PatientsLikeMe.com|PatientsLikeMe (PLM, www.patientslikeme.com) is an established medical social networking website that encourages patients with chronic medical conditions to voluntarily share their story and seek support from a common community. Additionally, PatientsLikeMe is actively exploring opportunities to allow patients to report and track important medical data points with the hope that this will improve their longitudinal care. PatientsLikeMe has developed custom functionality for the epilepsy population including seizure tracking, peer support, and printable doctor visit support sheets.
16152385|NCT01762202|Drug|Cyclophosphamide|
16152386|NCT01762202|Drug|Fludarabine|
16152387|NCT01762202|Drug|Ofatumumab|
16152388|NCT01762189|Procedure|Phototherapy|The decision to use phototherapy conformed to the hour-specific threshold value for phototherapy presented by the American Academy of Pediatrics guidelines and was not at the discretion of the investigators.
16152389|NCT01762176|Procedure|Protocolized intensive treatment|Intensive treatment is defined as early diagnosis, frequent assessment (monthly) of disease activity that guides treatment change with the aim to achieve clinical remission based on a tight control protocol
16152390|NCT01762176|Procedure|Usual care|Usual care is defined as treatment decision at the discretion of the rheumatologists and patients reflecting daily clinical practice
16152391|NCT01762163|Drug|Qizhitongluo Capsule|
16152392|NCT01762163|Drug|Naoxintong Capsule|
16152393|NCT01762163|Drug|Aspirin Enteric-coated Tablets|
16152394|NCT01762163|Behavioral|the routine recovery training|
16152395|NCT01762163|Drug|placebo|
16152396|NCT01762150|Drug|Sorafenib|Sorafenib 400mg BID by oral until progressed;
16152397|NCT01762150|Drug|Gemcitabine|Gemcitabine: 1000mg/m2, administered by intravenous drip for 30~60min on Day 1 and 8,for 4 cycles;
16152398|NCT01762150|Drug|Cisplatin|Cisplatin: 25mg/m2, administered by intravenous drip on Day 1-3, with appropriate liquid hydration,for 4 cycles.
16152399|NCT01762137|Procedure|Flow Diversion|Endovascular flow diverter placement
16152400|NCT01762137|Procedure|Coiling|Endovascular coil placement
16152401|NCT01762124|Device|Native Outflow Tract TPV|Transcatheter placement of a pulmonary valve
16152402|NCT01762085|Procedure|nerve decompression|surgical decompression involves surgical division or incision of perineural fibrous or fibro-osseous tunnel tissues which pinch, choke, compress or sharply deviate nerve trunks.
16152403|NCT01762072|Dietary Supplement|Fish oil|
16152404|NCT01762072|Dietary Supplement|vitaminB12|
16152405|NCT01762059|Device|Bi-homonal Bionic Pancreas|A computer algorithm will automatically deliver insulin lispro and glucagon based on the signal from a minimally invasive continuous glucose monitor.
16152406|NCT01762059|Other|Usual care|
16152407|NCT01762046|Drug|Glipizide|
16152411|NCT01762020|Device|3M Cavilon No Sting Barrier Film|Half the breast will receive 3M Cavilon No Sting Barrier Film and one half will receive standard skin care
16152412|NCT01762020|Drug|Standard Preparation|standard creams
16152413|NCT01761994|Drug|Anticoagulation with nafamostat mesilate|Initial dose of nafamostat mesilate is 20mg/hr. Dosage is adjusted from 10mg to 30mg/hr according to patients' status. For priming, two vial of nafamostat mesilate was dissolved in 2mL of 5% glucose fluid, and then mixed with 1000mL of normal saline. After carefully removing air bubble from the circuit with the prepared fluid, nafamostat mesilate was dissolved with 15 mL of 5% glucose fluid and loaded in anticoagulation line with starting dose of 20mg/hr.
16152414|NCT01761968|Drug|givinostat|"Patients will continue at their last tolerable dose and treatment schedule of givinostat monotherapy. Givinostat is a histone-deacetylases inhibitor. The product will be supplied as hard gelatine capsules for oral administration at the strength of 50 mg, 75 mg and/or 100 mg each.
~If patients previously received givinostat in combination with other drugs during a core protocol or a compassionate use program, they will be treated at their last tolerable dose of this combination."
16152415|NCT01761955|Other|High Dairy|Consuming 4 or more servings of dairy products per day for a period of 6 months
16152416|NCT01761942|Dietary Supplement|fatty acids preparation- eye-q|3x2 tablets daily by 70 days
16152417|NCT01761929|Radiation|Radiation: 50Gy in 5 fr (max) to 25 Gy in 5 fr (min). Dose adapted to deliver the highest dose level while respecting normal tissue tolerance|All patients will be treated with SBRT 1-2 weeks after radiotherapy planning scans. Therapy will be given once daily, over 5 consecutive working days according to standard practice.
16152418|NCT01761916|Drug|CLONIDINE|Postpartum patients with very high blood pressure will be treated with oral clonidine (0,1mg)
16152419|NCT01761916|Drug|CAPTOPRIL|Postpartum patients with very high blood pressure will be treated with oral captopril (25mg)
16152420|NCT01761890|Behavioral|Dasatinib discontinuation|Treatment decision is at the discretion of the investigator and must not be made on the basis of this observational study. Patients should have their treatment initiated in accordance with the summary of product characteristics.
16152421|NCT01761877|Drug|Sulindac|
16152422|NCT01761864|Behavioral|academic detailing intervention|
16152423|NCT01761838|Other|SMT for low back pain patients|High velocity, low amplitude spinal manipulative therapy (HVLA-SMT) will be provided to the lumbopelvic region on both sides.
16152424|NCT01761838|Other|Pain induction (optional)|A randomized crossover design is used to investigate the changes in spinal stiffness and back muscle activity of asymptomatic participants following an experimental pain induction procedure. Specifically, asymptomatic participants attend two separate sessions 5 days apart. Participants will receive 0.3 ml of 5% hypertonic saline or 0.9% isotonic saline in random order into the interspinous ligaments at L3 to L5 levels. The resulting temporal changes in pain intensity, spinal stiffness and trunk muscle activity following saline injections will be monitored. During the second session, the participants will undergo the same procedures but with the previously unused saline concentration.
16152425|NCT01761838|Other|Low back pain participants without SMT|No treatment
16152426|NCT01761825|Drug|ivabradine|
16152427|NCT01761812|Other|MRI with gadofosveset and MR elastography|
16152428|NCT01761799|Behavioral|P3 Vaccine Promotion Package.|"P3 stands for Practice, Provider, and Patient level vaccine promotion package. The 5 obstetric practices randomized to the intervention arm will receive this comprehensive influenza and Tdap vaccine promotion package at the beginning of the study. Physicians and staff will be familiarized with each component, and practices will be instructed to implement each component to the best of their ability. The components include: posters, educational brochures, lapel buttons, provider-to-patient talking points, lists of nearby locations offering flu and/or Tdap vaccines (if not offered by the practice), identification of a vaccine champion within the practice, provider and staff training on vaccination during pregnancy, and use of an interactive, tablet-based educational tutorial for patients."
16152429|NCT01761786|Genetic|CYP2C19 genotyping|CYP2C19 genotyping will be performed in the intervention group. In patients with *1/*1 genotype (Extensive Metabolizer) clopidogrel will be prescribed. All patients who are carrier of a loss-to-function (*2 or *3) gene allel and all patients randomized to the control group will be prescribed prasugrel or ticagrelor, according to local protocol.
16152430|NCT01761773|Drug|cabozantinib|3 20-mg strength capsules (60 mg dose) administered as a single oral dose on Day 1 of study participation.
16152431|NCT01761760|Behavioral|Videogame-based smoking cessation intervention|Patients will enroll in a videogame that is intended to help them quit smoking. They will be given goals for quitting (based on carbon monoxide readings submitted over a secure internet server) and will earn game-based incentives either contingent or noncontingent on meeting those goals.
16152432|NCT01761747|Drug|ponatinib|
16152433|NCT01761734|Behavioral|text message|
16152434|NCT01761708|Procedure|primary ventral hernia repair with mesh|
16152435|NCT01761695|Other|Diagnosed as CML|All patients who will be enrolled in this prospective registry are confined to those who are diagnosed as chronic myeloid leukemia at Asan Medical Center, Seoul, Korea, from Jan 2013 till Dec 2047
16152436|NCT01761682|Other|Diagnosed as ALL|All patients who will be enrolled in this prospective registry are confined to those who are diagnosed as acute lymphoblastic leukemia at Asan Medical Center, Seoul, Korea, from Jan 2013 till Dec 2047
16152437|NCT01761669|Drug|Vitamin D|
16152438|NCT01761656|Drug|loading dose atorvastatin|For loading dose atorvastatin intervention, patients will be treated with 80 mg atorvastatin (lipitor) 12 hours before PCI and 40 mg atorvastatin (lipitor) 2 hours before PCI and then 20mg/d after PCI.
16152439|NCT01761656|Drug|conventional dose atorvastatin|For conventional dose atorvastatin intervention, patients will be treated with 20 mg atorvastatin (lipitor) 12 hours before PCI and then 20mg/d after PCI.
16152440|NCT01761643|Device|SoC + iTab|Text messaging reminders to improve adherence to PrEP
16152441|NCT01761617|Behavioral|Yoga class once per week|"The protocol consists of one 75-minute yoga class per week for 12 weeks. The 12 weeks are divided into four 3-week segments, each with a theme (e.g., Listening to the Wisdom of the Body, Engaging your Power). The number of postures learned and degree of difficulty increases with each segment. The protocol provides variations and uses various aids (e.g., chair, yoga strap, yoga block) to accommodate a range of physical abilities. Classes are taught by a team of yoga instructors to ensure a low participant-to-teacher ratio."
16153094|NCT01756326|Drug|PREOB® Implantation|
16152442|NCT01761617|Behavioral|Yoga class twice per week|"The protocol consists of two 75-minute yoga classes per week for 12 weeks. The 12 weeks are divided into four 3-week segments, each with a theme (e.g., Listening to the Wisdom of the Body, Engaging your Power). The number of postures learned and degree of difficulty increases with each segment. The protocol provides variations and uses various aids (e.g., chair, yoga strap, yoga block) to accommodate a range of physical abilities. Classes will have eight participants at a time and are taught by a team of two yoga instructors to ensure a low yoga participant-to-teacher ratio."
16152443|NCT01761604|Device|Nasal ganglion block for TN|
16152444|NCT01761591|Device|PCI with Svelte Acrobat|Percutaneous coronary intervention with Svelte Acrobat Coronary Stent System
16152445|NCT01761591|Device|PCI with other BMS|Percutaneous coronary intervention with any other routine use CE marked bare metal stent (BMS) implantable either via direct stenting or after lesion pre-dilation
16152446|NCT01761578|Device|ART18Z Bioresorbable stent|The drug free fully bioresorbable coronary stent ART18Z is a balloon expandable poly lactic acid stent.
16152447|NCT01761565|Drug|Single dose of SUF NT 15 mcg|
16152448|NCT01761565|Drug|40 consecutive doses of SUF NT 15 mcg taken every 20 minutes|
16152449|NCT01761552|Drug|Sugammadex Reversal|
16152450|NCT01761552|Drug|Atropine/Neostigmine|
16152451|NCT01761539|Other|Aggressive Hydration|Receives 20cc/kg bolus and 3cc/kg/hr thereafter.
16152452|NCT01761539|Other|Moderate Hydration|Receives 10cc/kg bolus and 1.5cc/kg/hr thereafter.
16152453|NCT01761526|Drug|Rotigotine transdermal patch|Rotigotine transdermal patch, single-dose application over 24 hours 2 mg /24 hours (10 cm2)
16152454|NCT01761513|Drug|YH4808|"Group1
~adminitration of YH4808 dose1, bid for 2weeks
~wash-out period for 3weeks between period1 and period2
~adminitration of YH4808 dose2, qd for 2weeks"
16152455|NCT01761513|Drug|YH4808|"Group2
~adminitration of YH4808 dose2, qd for 2weeks
~wash-out period for 3weeks between period1 and period2
~adminitration of YH4808 dose1, bid for 2weeks"
16152456|NCT01761513|Drug|YH4808|"Group3
~adminitration of YH4808 dose2, bid for 2weeks
~wash-out period for 3weeks between period1 and period2
~adminitration of Nexium tab 40mg, bid for 2weeks"
16152457|NCT01761513|Drug|YH4808|"Group 4
~adminitration of Nexium tab 40mg, bid for 2weeks
~wash-out period for 3weeks between period1 and period2
~adminitration of YH4808 dose2, bid for 2weeks"
16152458|NCT01761500|Other|Modified BFM-90 protocol|Using Modified BFM-90 protocol to treat Chinese children and Adolescents with NHL
16152459|NCT01761487|Device|Gentamicin and polymyxin E|
16152460|NCT01761461|Drug|TS-1, oxaliplatin|
16152461|NCT01761448|Device|Guide Exercise (GEx-)- Training|Both intervention and control group undergo a baseline evaluation and an end evaluation including tests of the clinical routine like cardiopulmonary test (CPX), echocardiography and lactate measurement. They will also answer questionnaires referring to quality of life and the use of the system. During the training phase at home the interventional group will test the supervised training system during endurance training such as running, biking or walking and during resistance training such as performing exercise with rubber bands (at least 3x a week for about 5-6 months according to the generated prescription plan during training at the hospital). They will report their daily activity by diary. The control group will only report their physical activities by diary without using the Gex- System. At the end data are investigated to determine whether the supervised training with the GEx- System will improve the physical capacities ( VO2 peak) of patients.
16152462|NCT01761448|Device|Guided Exercise Training with an easy to wear vest with electrodes to measure ECG, respiration, activity|
16152463|NCT01761448|Device|Control group training without Guided Exercise system at home|
16152464|NCT01761435|Biological|Influenza vaccine|"Patients will be randomized at 1:1 rate and open label fashion, according to centers, and time elapsed since transplant and type of organ transplanted to one of this two interventions :
~A arm (usual treatment): Influenza vaccine (split virion, inactivated) suspension for injection 0.5ml at the baseline.
~B arm (experimental branch): Influenza vaccine (split virion, inactivated) suspension for injection 0.5ml at the baseline and 5 weeks after the first dose.
~The follow-up of both arms will be at 5, 10 and 15 weeks and one year after the baseline."
16152465|NCT01761396|Behavioral|CBT|
16152466|NCT01761396|Behavioral|UC|
16152467|NCT01761383|Other|Nintendo Wii video console and Nintendo Wii Fit Plus games|The intervention will be provision of Nintendo Wii console and Wii Fit Plus video games to use for the duration of the study with no restrictions or limitations on the games participants are allowed to play or duration of play. There will be 5 home visits over a 6-month period to evaluate Nintendo Wii use and assess patients'health, functioning and quality of life.
16152468|NCT01761370|Procedure|AHA diet plus exercise with BIB placement|AHA diet plus exercise with BIB placement for 6 months
16152469|NCT01761370|Procedure|AHA diet plus exercise with sham BIB placement|AHA diet plus exercise with sham BIB placement
16152470|NCT01761357|Other|answering to questionnaires of quality of live|
16152471|NCT01761344|Other|Intraoperative cortisol measurement.|Levels of cortisol in blood samples will be determined using a rapid cortisol assay. This is not standard procedure
16152472|NCT01761331|Other|Acupuncture|"Minimal standardized acupuncture: one needle is inserted about 3 mm in the point LI4 on the infants hands, unilaterally, for 2-10 seconds and then withdrawn.
~Individualized acupuncture: maximum 5 needles are inserted, about 3 mm deep, in points chosen by the acupuncturists according to symptoms, in points recommended in a guideline produced for the trial. Needles are retained for maximum one minute."
16152473|NCT01761318|Drug|Liraglutide|"Preparation and labelling of Investigational Medicinal Product:
~Liraglutide will be packed and labeled by Novo Nordisk A/S and provided in non-subject specific boxes. Labeling will be in accordance with Annex 13, local law and trial requirements. The examples of labels are not readily available, but will be supplied when received from Novo Nordisk.
~Drug accountability:
~Drug accountability will be cared for by the Department of Clinical Pharmacy of the LUMC. The trial product will be dispensed to each subject as required according to treatment group by the clinical pharmacist. No trial product will be dispensed to any person not enrolled in the trial."
16152538|NCT01760759|Behavioral|contingency management for adherence|Patients will receive reinforcement in the form of vouchers for each video that they send in indicating adherence at the appropriate time.
16152659|NCT01759836|Drug|Atorvastatin 20mg|Atorvastatin 20mg daily for 1 year
16153095|NCT01756326|Procedure|Bone Autograft|
16152474|NCT01761318|Drug|Liraglutide - Placebo|"Preparation and labelling of Investigational Medicinal Product:
~Liraglutide - Placebo will be packed and labeled by Novo Nordisk A/S and provided in non-subject specific boxes. Labeling will be in accordance with Annex 13, local law and trial requirements. The examples of labels are not readily available, but will be supplied when received from Novo Nordisk.
~Drug accountability:
~Drug accountability will be cared for by the Department of Clinical Pharmacy of the LUMC. The trial product will be dispensed to each subject as required according to treatment group by the clinical pharmacist. No trial product will be dispensed to any person not enrolled in the trial."
16152475|NCT01761305|Procedure|Hypercorrective night-time brace|Hypercorrective night-time brace worn 8 hours per night. Patients are encouraged to also continue with non-specific self-mediated physical activities of moderate intensity at least 60 minutes daily, for the entirety of the study. Reinforcement of the assigned intervention will be performed in conjunction with reassessment every 6 months. A training diary will be implemented to follow and motivate the patient's training behaviour.
16152476|NCT01761305|Behavioral|Scoliosis specific exercises.|The intervention will be delivered in 3 x 90 minute sessions, once per month during the first 3 months. Goals are directed towards active self-correction and postural control, spinal stability, aerobic functioning and development of a positive body image. Additional postural specific exercises including self-mediated hyper-corrective exercises are to be performed with moderate intensity at least for 30 minutes at least 2-3 times per week. Other physical activities to fulfill the general recommended quota of more than 60 minutes moderate intensity physical activity per day are recommended. Reinforcement of the intervention will be performed in conjunction with reassessment every 6 months. A training diary will be implemented to follow and motivate the patient's training behaviour.
16152477|NCT01761305|Other|Self-mediated physical activity.|Instructions for self-mediated physical activity will be delivered during a 1 hour session. Patients are encouraged to perform self-mediated physical activities of moderate intensity at least 60 minutes daily, for the entirety of the study. Reinforcement of the assigned intervention will be performed in conjunction with reassessment every 6 months. A training diary will be implemented to follow and motivate the patient's training behaviour.
16152478|NCT01761292|Drug|Givinostat|Givinostat, oral suspension 10 mg/mL or oral capsules 50 mg, administered orally under fed conditions at the dose of 25 mg BID, 37.5 mg BID, and 50 mg BID during Part 1 for two weeks, and 25 mg BID and 37.5 mg BID during Part 2 for 12 months. Givinostat, oral suspension 10 mg/mL, administered orally under fed conditions at the dose of 25 mg BID or 37.5 mg BID during Extension 1, and modified as per patient's weight during Extensions 2 and 3 (up to 52 months).
16152479|NCT01761279|Procedure|High definition white light endoscopy|
16152480|NCT01761266|Drug|Lenvatinib|12 mg (or 8 mg) once daily (QD) oral dosing.
16152481|NCT01761266|Drug|Sorafenib|400 mg twice daily (BID) oral dosing.
16152482|NCT01761240|Drug|MORAb-066|
16152483|NCT01761227|Drug|Fufangdanshen Tablets|1 tablets contains contains tanshinoneⅡA 0.67mg , salvianolic acid B 8.2mg, Panax Notoginsenosides R1 0.53mg, ginsenoside Rb1 3.03mg, ginsenoside Rg1 2.73mg, 3 tablets per time, 3 times per day for 24 weeks
16152484|NCT01761227|Drug|Placebo|Placebo for 3 tablets per time, 3 times per day for 24 weeks
16152485|NCT01761214|Drug|Fluroquinolones|All antibiotics are administered based on British Thoracic Society guideline for bronchiectasis
16152486|NCT01761214|Drug|Beta-lactamase inhibitor|All antibiotics are administered based on British Thoracic Society guideline for bronchiectasis.
16152487|NCT01761201|Drug|Levofloxacin|Levofloxacin
16152488|NCT01761201|Drug|Isoniazid|"300 mg/day for 9 months beginning after transplantation, when the liver function is stable and not before 3 months nor after 6 months."
16152489|NCT01761188|Procedure|Ablation|electrophysiology substrate mapping is the critical difference between both groups
16152490|NCT01761175|Procedure|Ultrasound-guided infraclavicular block|Ultrasound-guided single injection infraclavicular block: using an in-plane technique, 30 mL of mepivacaine 1.5% is injected at the posterior aspect of the artery.
16152491|NCT01761175|Procedure|Ultrasound-guided axillary block|Ultrasound-guided double injection axillary block: using an in-plane technique, 25 mL of mepivacaine 1.5% is injected postero-medial to the artery. During needle withdrawal, 5 mL of the same solution is injected close to the musculocutaneous nerve.
16152492|NCT01761162|Device|Patients with a ProMRI Pacemaker System|Bradycardia Slow Heart Beat
16152493|NCT01761162|Other|Magnetic Resonance Imaging (MRI) scan|MRI scan of head and lower back.
16152494|NCT01761149|Drug|Remifentanil|The present study examine two different dose of remifentanil: low dose (0.2ug/kg/min) and high dose (1.2ug/kg/min)
16152495|NCT01761136|Biological|Inoculation in upper arm deltoid|Inoculation of Hib vaccine of two brands in upper arm deltoid
16152496|NCT01761136|Biological|Inoculation in vastus lateralis muscle|Inoculation of Hib vaccine of two brands in vastus lateralis muscle
16152497|NCT01761123|Biological|VXA-A1.1|
16152498|NCT01761110|Behavioral|Community-based buprenorphine treatment (CBBT) intervention|Community-based buprenorphine treatment (CBBT) intervention consists of three components which are delivered to staff of syringe exchange programs, including: 1) providing buprenorphine education, 2) facilitating access to buprenorphine treatment, and 3) providing support to individuals who initiate buprenorphine treatment.
16152499|NCT01761097|Device|Endocuff attachment|Endocuff
16152500|NCT01761084|Behavioral|Exercise and behaviour change strategies|"cardiovascular exercise (e.g., marching, walking) for ≥10 minutes per day
~postural retraining and balance exercises ≥3 days a week (will be encouraged to do these daily)
~perform muscle strengthening and balance training exercises ≥ 3 days a week
~the exercise intervention was developed using the Bone Fit program as a framework (http://www.bonefit.ca/). The physical therapist will tailor exercises and work with participant to integrate them into their day."
16152501|NCT01761071|Drug|topical ketorolac 0.5% (Acular®, Allergan Inc, Irvine, CA)|On operation day, the patients were randomly assigned to one of the following two groups: group KO,preoperative application of topical ketorolac 0.5% (Acular®, Allergan Inc, Irvine, CA) in one eye and topical ofloxacin 0.3% (Ocuflox®, SamilInc, Seoul, Korea)in the other eye; group DO, topical diclofenac 0.1% (Voltaren®, Novartis, Bern, Switzerland) in one eye and ofloxacin 0.3% in the other eye. Neither the surgeon nor the participants knew which ophthalmic would go to which eye. A randomly assigned ophthalmic was instilled into right eye first three times by 1 minute interval 30 minutes prior to operation and the other ophthalmic was instilled into left eye with the same manner 10 minute later.
16152502|NCT01761071|Drug|topical diclofenac 0.1% (Voltaren®, Novartis, Bern, Switzerland)|On operation day, the patients were randomly assigned to one of the following two groups: group KO,preoperative application of topical ketorolac 0.5% (Acular®, Allergan Inc, Irvine, CA) in one eye and topical ofloxacin 0.3% (Ocuflox®, SamilInc, Seoul, Korea)in the other eye; group DO, topical diclofenac 0.1% (Voltaren®, Novartis, Bern, Switzerland) in one eye and ofloxacin 0.3% in the other eye. Neither the surgeon nor the participants knew which ophthalmic would go to which eye. A randomly assigned ophthalmic was instilled into right eye first three times by 1 minute interval 30 minutes prior to operation and the other ophthalmic was instilled into left eye with the same manner 10 minute later.
16152503|NCT01761045|Dietary Supplement|Soup 1|Consommé soup with Monosodium L-Glutamate (MSG)
16152504|NCT01761045|Dietary Supplement|Soup 2|Consommé soup with Monosodium L-Glutamate (MSG) and Nucleic Acid (IMP)
16152505|NCT01761045|Dietary Supplement|Soup 3|Placebo soup with no Monosodium L-Glutamate (MSG) or Nucleic Acid (IMP)
16152506|NCT01761032|Device|Tanning|Participants will be placed under a tanning canopy for 4-10 minutes.
16152507|NCT01761019|Drug|Taclonex Topical Suspension|topical medication for psoriasis
16152508|NCT01761006|Device|NIOX MINO®|
16152509|NCT01760993|Drug|SPD489|Once-daily oral optimized doses of SPD489 (either 40 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg) for 52 weeks
16152510|NCT01760980|Drug|Reference product (A) Aromasin (Exemestane)|Aromasin tablets will be administered under fasting conditions on two occasions
16152511|NCT01760980|Drug|Test product (B) Exemestane|Exemestane tablets will be administered under fasting conditions on one occasion
16152512|NCT01760967|Drug|Dexmedetomidine|intervention to administer dexmedetomidine or not
16152513|NCT01760954|Drug|Elagolix|Elagolix tablets administered orally
16152514|NCT01760941|Radiation|Radiation Therapy|Undergo standard of care radiation therapy
16152515|NCT01760941|Other|Quality-of-Life Assessment|The patient quality of life as measured by the ESAS-r; Edmonton Symptom Assessment System revised.
16152516|NCT01760941|Other|Survey Administration|The surveys consists of Radiation Therapy Worthfullness survey; BPI: brief pain inventory; NUS: narcotics usage survey.
16152517|NCT01760915|Other|NC100182 Hyperpolarized 3He|Magnetic Resonance Imaging (MRI) will take place and include inhalation of hyperpolarized helium to construct an image of the lungs.
16152518|NCT01760902|Behavioral|Diet and Physical Activity|The group will convene weekly for 12 consecutive weeks and monthly thereafter for 9 consecutive months. Thus, there will be a total of 21 group-based sessions over the one-year period
16152519|NCT01760889|Drug|SPD489 low dose range (40mg, 80mg, and 100mg)|"Capsule, dose titration,
~40 mg capsule once-daily for 1 week; then
~80 mg capsule once-daily for 4 weeks; then,
~100 mg capsule once-daily (if unable to tolerate 100 mg dose between weeks 5 to 6, then dose to be decreased to 80 mg once-daily for the remaining 21 weeks;
~if able to tolerate 100 mg dose then will continue on 100 mg capsule once-daily for 21 weeks"
16152520|NCT01760889|Drug|SPD489 high dose range (120mg, 140mg and 160mg)|"Capsule, dose titration,
~40 mg capsule once-daily for 1 week; then
~80 mg capsule once daily for 1 week; then
~120 mg capsule once-daily for 1 week, then,
~140 mg capsule once-daily for 2 weeks, then
~160 mg once capsule once-daily (if unable to tolerate 160 mg dose between weeks 5 to 6, then dose to be decreased to 140 mg once-daily for the remaining 21 weeks;
~if able to tolerate 160 mg dose then will continue on 160 mg capsule once-daily for 21 weeks"
16152521|NCT01760889|Drug|Placebo|One capsule a day for 26 weeks
16152522|NCT01760876|Device|coronary intervention|The BioFreedom drug coated stent (DCS) Coronary Stent Delivery System is comprised of three key components
16152523|NCT01760863|Other|Oral Antibiotics|Oral Antibiotics will be prescribed for 3 months per recommendations of an infectious disease specialist.
16152524|NCT01760850|Other|educational intervention|Engage in the Esperanza y Vida educational information session for breast and cervical cancer
16152525|NCT01760850|Other|educational intervention|Engage in an educational information session for diabetes
16152526|NCT01760850|Other|questionnaire administration|Ancillary studies
16152527|NCT01760837|Other|Baked milk products to cow's milk allergic patients|
16152528|NCT01760824|Drug|Sequential therapy|Esomeprazole 20mg bid for 10 days, amoxicillin 1g bid for first 5 days, clarithromycin 500mg bid for last 5 days and metronidazole 400mg qid for last 5 days
16152529|NCT01760824|Drug|Quadruple therapy|Esomeprazole 20mg bid, metronidazole 400mg qid, bismuth sub citrate 120mg qid and tetracycline 500mg qid, all for 10 days
16152530|NCT01760811|Drug|Erbitux,merck serono|cetuximab loading dosage 400mg/m2 followed by weekly 250mg/m2 2 weeks
16152531|NCT01760798|Drug|Teriparatide|
16152532|NCT01760785|Drug|divalproex sodium|Doses will be given in 250mg increments and titrated over the first four days of study until a starting dose of 750 mg is reached. The Study Oversight Team, who is not involved in any clinical visits, will be un-blinded to study drug assignment and will have plasma concentration results and adverse event reports available to them. If a subject has no adverse events and is not at therapeutic level as indicated by the blood levels, the Study Oversight Team may inform the research pharmacy to increase the dose by 1 tablet of 250 mg to 1000 mg per day. The Study Oversight Team may also inform the research pharmacy to reduce the daily dosage back down to 750 mg per day if plasma concentrations or adverse events become intolerable. The maximum dose for the purpose of this study will be 1250 mg daily and the minimum dose will be 750 mg daily. Subjects who cannot tolerate the minimum dose will be excluded from any further study participation.
16152533|NCT01760785|Drug|Placebo|Doses will be titrated over the first four days of study in the same manner as the active study drug. After titration, the research pharmacy may increase the dose by 1 tablet per day, in the same fashion that the active drug may be adjusted, so that the participant and clinical team remain blinded to the drug assignment. The research pharmacy may also reduce the daily dosage back down by one tablet per day for the same reason.
16152534|NCT01760772|Drug|Exendin-9|Bolus of Ex-9 (7500 pmol/kg) over 1 minute followed by continuous infusion at 750 pmol/kg/min
16152535|NCT01760772|Drug|GLP-1|Constant infusion of GLP-1 at 0.3 pmol/kg/min
16152536|NCT01760772|Other|saline|Constant infusion
16152537|NCT01760759|Behavioral|cell phone reminders|Patients receive reminders, scheduled to occur daily at time(s) of scheduled antiretroviral therapy dosing.
16152656|NCT01759862|Other|Theophylline drug levels|Theophylline drug levels will be monitored every morning from all patients for the first 4 days post- transplant.
16152539|NCT01760746|Other|Injection of Avastin / Lucentis, sampling aqueous humour|"Study participants will be divided into two arms. Subjects will receive Avastin or Lucentis a few days before vitrectomy surgery. The assignment will be double-masked.The first sample of aqueous humor will be obtained immediately prior to the intravitreal injection.
~On the same of the intravitreal injection, a blood sample will be taken for hemoglobin A1C measurement. Approximately 1 week later when patients are having their scheduled vitrectomy surgery, an additional sample of aqueous humour will be obtained .
~Intraocular cytokines levels will be measured in aqueous humor samples using multiplex cytokine assays."
16152540|NCT01760720|Behavioral|MMT CARE|
16152541|NCT01760707|Behavioral|exercise training|
16152542|NCT01760707|Behavioral|usual care|
16152543|NCT01760694|Other|Multi-Modality; IORT, Surgery, Radiation, Chemotherapy|
16152544|NCT01760681|Device|H- Coil DTMS|20 daily deep rTMS treatments
16152545|NCT01760681|Device|Sham|
16152546|NCT01760655|Drug|Fludarabine phosphate|Given IV
16152547|NCT01760655|Drug|Thiotepa|Given IV
16152548|NCT01760655|Radiation|Total body irradiation|Undergo TBI
16152549|NCT01760655|Biological|Therapeutic allogeneic lymphocytes|Undergo donor lymphocyte infusion
16152550|NCT01760655|Drug|Cyclophosphamide|Given IV
16152551|NCT01760655|Procedure|Allogeneic hematopoietic stem cell transplantation (HSCT)|Undergo allogeneic PBSCT
16152552|NCT01760655|Procedure|Peripheral blood stem cell transplantation|Undergo allogeneic PBSCT
16152553|NCT01760655|Drug|Tacrolimus|Given IV
16152554|NCT01760655|Drug|Mycophenolate mofetil|Given IV
16152555|NCT01760642|Drug|Midazolam|Midazolam 3 mg IV
16152556|NCT01760642|Drug|Ketoconazole|ketoconazole 400 mg PO
16152557|NCT01760642|Drug|Rifampicin|Rifampicin 600 mg PO
16152558|NCT01760629|Device|Tecotherm-HELIX|Whole body cooling using Tecotherm-HELIX
16152559|NCT01760616|Drug|Huaier Granule|Huaier Granule is a Chinese medicine, specifications: 20g / bag, manufacturer: Qidong Gaitianli Medicines Co., Ltd..
16152560|NCT01760603|Procedure|ISFF|Ischia spinous fascia fixation surgery was performed on patient with pelvic organ prolapse.
16152561|NCT01760590|Procedure|Manual Manipulation|A grade 5 thrust to the thoracic spine
16152562|NCT01760590|Procedure|Mobilization|A grade 1-4 mobilization directed at thoracic spine
16152563|NCT01760577|Drug|Botulinum Toxin A (Allergan, Inc, Irvine CA)|patients received intraarticular injections by the same experienced physician using aseptic procedures.
16152564|NCT01760577|Drug|Hyalgan (Hyalgan, Fidia , Italy)|The rehabilitation program consists of 6 sessions of rehabilitation exercise for 50 miniutes/day, 3 days per week for 2 weeks and home exercise program for another 2 weeks.
16152565|NCT01760564|Drug|Miglustat|miglustat 200mg tid for adult. For children surface area correction will be made. A lower dose may be used initially to decrease side effect.
16152566|NCT01760538|Behavioral|Exercise training|exercise training
16152567|NCT01760538|Behavioral|usual care|received usual medical care after heart transplantation
16152568|NCT01760525|Drug|CGM097|Patients treated with CGM097
16152569|NCT01760512|Procedure|Gastric bypass|Gastric bypass
16152570|NCT01760499|Drug|PV-10|PV-10 administration: Within one week after completing the screening tests (or the same day as the screening tests), participants will be scheduled to have the study drug (PV-10) administered. PV-10 is given as an injection with a needle, directly into one of the participant's tumors. Participants will be given an injection of a numbing medication before the PV-10 is given.
16152571|NCT01760499|Procedure|Surgery|Surgery to remove melanoma tumors (Day 7-14): About 7-14 days after the PV-10 is given, participants will have surgery to remove their melanoma tumors. A piece of the tumor that was injected with PV-10 along with a piece of one other tumor will be sent to the laboratory for testing as part of the study.
16152572|NCT01760486|Behavioral|Shape Up Rhode Island|
16152573|NCT01760486|Behavioral|Shape Up Rhode Island + Professional Coach + Incentives|
16152574|NCT01760486|Behavioral|Shape Up Rhode Island + Peer Coach + Incentives|
16152575|NCT01760473|Drug|Intranasal challenge drug|Each of the experimental challenge drugs were administered intranasally to all participants in random order.
16152576|NCT01760460|Drug|Anacetrapib|
16152577|NCT01760460|Drug|Placebo for anacetrapib|
16152578|NCT01760447|Drug|Sitagliptin plus metformin|Participants received 2 tablets daily, one taken with a morning meal and one taken with an evening meal, to provide a total daily dose of 100 mg of sitagliptin and 1000 mg, 1700 mg or 2000 mg of metformin. Dosage of metformin was based on each participant's daily metformin dose prior to enrollment.
16152579|NCT01760447|Drug|Placebo to metformin|Participants received 2 tablets daily, one taken with a morning meal and one taken with an evening meal. Each tablet contained placebo to metformin.
16152580|NCT01760447|Drug|Metformin|Participants received 2 tablets daily, one taken with a morning meal and one taken with an evening meal, to provide a total daily dose of 1000 mg, 1700 mg or 2000 mg of metformin. Dosage was based on each participant's daily metformin dose prior to enrollment.
16152581|NCT01760447|Drug|Placebo to sitagliptin plus metformin|Participants received 2 tablets daily, one taken with a morning meal and one taken with an evening meal. Each tablet contained placebo to sitagliptin plus metformin.
16152582|NCT01760447|Drug|Sitagliptin plus metformin XR|Participants received 2 tablets daily, both taken together with a meal, to provide a total daily dose of 100 mg of sitagliptin and 1000 mg, 1500 mg or 2000 mg of metformin. Dosage of metformin XR was based on each participant's daily metformin dose prior to enrollment.
16152583|NCT01760447|Drug|Placebo to metformin XR|Participants received 2 tablets daily, both taken together with a meal. Each tablet contained placebo to metformin XR.
16152584|NCT01760447|Drug|Insulin|"Participants who met protocol-specific glycemic rescue criteria received insulin as glycemic rescue therapy; participants on background insulin had their insulin dose increased for glycemic rescue. During Weeks 20-54, for participants who were not on background insulin or rescued with insulin during Weeks 0-20 in the Sitagliptin/Metformin and Metformin arms (protocol MK-0431A-170), and during Weeks 0-54 for participants not on background insulin in the Sitagliptin/Metformin XR and Metformin XR arms (protocol MK-0431A-289), the type of insulin for glycemic rescue was specified to be insulin glargine."
16152740|NCT01759199|Procedure|Pulmonary rehabilitation assessed with six-minute walk test and six-minute stepper test|
16152585|NCT01760447|Drug|Placebo to sitagliptin plus metformin XR|Participants received 2 tablets daily, both taken together with a meal. Each tablet contained placebo to sitagliptin plus metformin XR.
16152586|NCT01760447|Drug|Metformin XR|Participants received 2 tablets daily, both taken together with a meal, to provide a total daily dose of 1000 mg, 1500 mg or 2000 mg of metformin XR. Dosage was based on each participant's daily metformin dose prior to enrollment.
16152587|NCT01760434|Other|Long-term outcomes|Patients with a history of adolescent idiopathic scoliosis will return at a minimum of 20 year follow-up for new spine xrays, clinical exam, pulmonary function testing, and assessment of health related quality of life based on survey responses.
16152588|NCT01760421|Drug|Hydroxychloroquine|Hydroxychloroquine (200mg/tab) 1 tab twice daily orally for 6 months
16152589|NCT01760408|Other|all patients on Home Parenteral Nutrition|
16152590|NCT01760382|Device|Primary PCI|mechanical reopening of the STEMI-related coronary artery by PTCA, with or without coronary stent implantation
16152591|NCT01760343|Biological|Berinert|Berinert is a plasma-derived C1 esterase inhibitor (human), supplied as a freeze-dried powder for reconstitution.
16152592|NCT01760343|Biological|CSL830|CSL830 is a formulation of Berinert.
16152593|NCT01760330|Drug|IV acetaminophen|
16152594|NCT01760330|Drug|Placebo|
16152595|NCT01760317|Procedure|Midline vs Parasagittal Lumbar Epidural Steroid Injection|
16152596|NCT01760304|Drug|Budesonide / Formoterol|"Budesonide/ formoterol (B/F) 160/4.5 mcg per activation. Subject who met inclusion criteria will be have at each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of either Budesonide/formoterol (B/F) 160/4.5 mcg per activation (as per the randomization-crossover schema).
~After 45 minutes , the above measurements will be repeated."
16152597|NCT01760304|Drug|Placebo|"Each visit day lung function, heart function and breathlessness measurements at baseline, then they will receive 2 puffs of placebo (as per the randomization-crossover schema).
~After 45 minutes , the above measurements will be repeated."
16152598|NCT01760291|Device|WATCHMAN LAA Closure Technology|
16152599|NCT01760278|Drug|recombinant Follicle Stimulating Hormone (rFSH)|"There are two arms of the study. The Study arm and the Control arm. In each arm, subjects, after randomization, will be stimulated with rFSH 225IU/day.
~On day 6, Cetrorelix 0.25mg/day to be added till the day of Ovitrell. Thereafter, ovum pick-up and embryo transfer to be done. Six weeks after transfer clinical pregnancy identified which will be the end-point of the study."
16152600|NCT01760252|Drug|Capecitabine, Oxaliplatin and Irinotecan (CAPOXIRI)|Neoadjuvant CAPOXIRI chemotherapy is an innovative strategy that builds on the advancement associated with FOLFIRINOX chemotherapy in patients with metastatic disease
16152601|NCT01760239|Behavioral|Clinical Decision Support (CDS)|The Clinical Decision Support (CDS) tool will be activated when a BP is entered in the vital sign section of the EHR. The CDS tool includes six key features: (i) prompts regarding the need for height data to classify the BP by percentile (ii) prompts to repeat any BP that is ≥90% or ≥120/80 mm Hg (iii) classification of BPs by percentile, including classification of those in pre-HT, stage 1 HT and stage 2 HT range (iv) review of previous HT diagnoses and BPs in order to classify elevated BPs as incident (first or second elevated BP) or persistent (third or greater elevated BP) (v) tailored CDS based on HT category and previous diagnoses (vi) graphical representation of current and historical BP data by age and BP percentile.
16152602|NCT01760226|Drug|DA-EPOCH-R for DLBCL, PTLD, AND PMBCL|"Day 1: Rituximab IV
~Days 1-4: After rituximab, etoposide, vincristine, and doxorubicin will be given in a vein over 96 hours as a continuous infusion.
~Day 5: cyclophosphamide will be given in a vein
~Days 1-5: prednisone given by mouth twice a day
~G-CSF 5mcg/kg/day will be given under the skin from day 6 until ANC has improved."
16152603|NCT01760226|Drug|Methotrexate|"CNS negative patients with high CNS risk DLBCL will receive age based, intrathecal dosing of MTX on days 1 and 5 of cycles 3 - 6 only.
~CNS positive patients will receive age based, intrathecal (within the spinal fluid) MTX twice weekly for 2 weeks past the first negative cytology with a minimum of 4 weeks treatment. Then, weekly for 6 weeks and then every 4 weeks for 6 months.
~DLBCL/PTLD/PMBCL CNS prophylaxis for cycles 3-6 ONLY if:
~2+ extranodal sites
~elevated LDH,
~MYC rearrangement OR
~bone or marrow disease.
~ALL OTHERS receive IT MTX cycles 3-6."
16152604|NCT01760226|Drug|Etoposide|Etoposide will be given at 50mg/m2/day on days 1-4 of the first cycle of therapy (dose based on patient height and weight). The doses in later cycles will be adjusted up or down based on the patient's blood test results.
16152605|NCT01760226|Drug|Doxorubicin|Doxorubicin will be given at 10mg/m2/day on days 1-4 of the first cycle (dose based on patient height and weight). The doses in later cycles will be adjusted up or down based on the patient's blood test results.
16152606|NCT01760226|Drug|Vincristine|Vincristine will be given on days 1-4 of each cycle at 0.4mg/m2/day (dose based on patient height and weight).
16152607|NCT01760226|Drug|Rituximab|Rituximab (375mg/m2/dose) will only be given on Day 1 of each cycle prior to all the other chemotherapy agents. Dose is based on patient height and weight.
16152608|NCT01760226|Drug|Cyclophosphamide|Cyclophosphamide will be given on Day 5 of each cycle. In cycle 1, the dose will be 750 mg/m2 (based on patient height and weight), and the dose will be adjusted up or down for future cycles based on blood test results.
16152609|NCT01760226|Drug|Prednisone|Prednisone will be given by mouth at 60mg/m2/dose (based on height and weight) twice a day on days 1-5 of each cycle.
16152610|NCT01760226|Drug|G-CSF|G-CSF will be given at 5 mcg/kg/day during each cycle, starting on day 6, until the patient's ANC (absolute neutrophil count) is greater than 5000/mcL past nadir.
16152611|NCT01760213|Other|CBT delivered via Internet|
16152612|NCT01760187|Drug|lomitapide|
16152613|NCT01760174|Drug|Ropivacaine bolus in transversus abdominis plane catheter|"Ropivacaine 7,5 mg/ml, 10-25 ml in each catheter, depending on patient weight, the total dose of ropivacaine is kept less than 3 mg/kg for every bolus. Bolus is given every 6 hours, the first bolus is given just after induction of general anesthesia and the last bolus after 24 hours.
~In the epidural catheter a bolus of 8 ml isotonic potassium chloride is given and an infusion of isotonic potassium chloride, 4-7 ml/t depending on patient height is started and runs for the first 24 hours."
16152657|NCT01759862|Drug|Placebo|Patients will receive placebo infusion of normal saline, pre-transplant, followed by normal saline infusions matched by volume and frequency to treatment arm for a total of 20 doses.
16152658|NCT01759849|Other|Allergen|Allergen extract is administered by inhalation.
16152614|NCT01760174|Drug|Bupivacain-infusion in epidural catheter|"Isotonic potassium chloride, 10-25 ml in each transversus abdominis catheter, depending on patient weight. Bolus is given every 6 hours, the first bolus is given just after induction of general anesthesia and the last bolus after 24 hours.
~In the epidural catheter a bolus of 8 ml bupivacaine 2,5 mg/ml is given and an infusion of isotonic potassium chloride, 4-7 ml/t depending on patient height is started and runs for the first 24 hours"
16152615|NCT01760161|Drug|Ropivacaine|Ropicacain 3,75 mg/ml 15 ml x 4 when placing the Bilateral Dual Transverus Abdominis Plane block
16152616|NCT01760161|Drug|Isotonic potassium chloride|Isotonic potassium chloride 15 ml x 4 when placing the bilateral dual transverus abdominis plane block.
16152617|NCT01760148|Drug|interferon alpha 2b|"Interferon:dosage,5 million units/person;frequency,every other day (qod);duration,48 weeks;Subcutaneous injection.
~Ribavirin: dosage,15mg/kg/day;frequency,three times a day (t.i.d);duration,48 weeks;take orally."
16152618|NCT01760135|Dietary Supplement|high caloric nutritional supplement|high caloric nutritional supplement (25kcal/kg)
16152619|NCT01760135|Dietary Supplement|low caloric nutritional supplement|low caloric nutritional supplement(15kcal/kg)
16152620|NCT01760122|Drug|Ypeginterferon alfa-2b|sc, qw, 48 weeks.
16152621|NCT01760122|Drug|Pegasys|sc, qw, 48 weeks.
16152622|NCT01760109|Drug|Piperacillin Sodium and Sulbactam Sodium|1.5-3.0g,iv,bid 7-14 days serious infections 6.0-12.0g,iv,tid for 7-14 days
16152623|NCT01760096|Drug|Levamisole+cyclosporin A+Glucocorticoids|Levamisole 2.5mg/kg every other day cyclosporin A 3-5mg/kg every other day Glucocorticoids0.25 mg/kg every day(prednisone)
16152624|NCT01760096|Drug|cyclosporin A+Glucocorticoids|cyclosporin A 3-5mg/kg every day Glucocorticoids0.25mg/kg every day(prednisone)
16152625|NCT01760096|Drug|Glucocorticoids|Glucocorticoids0.25mg/kg every day(prednisone)
16152626|NCT01760083|Device|Biolimus-eluting stent implantation|Recanalization of chronic coronary artery occlusion and subsequent implantation of one or ore Biosensor stents
16152627|NCT01760070|Device|Hybrid knife|Use Hybrid knife in ESD procedure
16152628|NCT01760070|Device|IT knife|Use IT knife in ESD procedure.
16152629|NCT01760057|Behavioral|Online HIV testing motivational videos and messages sent via mobile-phone text messaging, e-mail or instant messaging|
16152630|NCT01760057|Behavioral|Standard online message with an invitation for free HIV testing similar in content to other Peruvian websites|
16152631|NCT01760044|Device|Tissue oxygenation monitoring|The device provides continuous measures with updates based on the previous 10 seconds worth of data. Data is continuously stored.
16152632|NCT01760031|Other|Ischemic preconditioning|Subjects received ischemic preconditioning previous to cardiac catheterization
16152633|NCT01760018|Drug|desflurane group|anesthesia is maintained with desflurane and remifentanil (Desflurane group)
16152634|NCT01760018|Drug|TIVA group|anesthesia is maintained with fresofol and remifentanil (TIVA group).
16152635|NCT01760005|Drug|Gantenerumab|Subcutaneously every 4 weeks at escalating doses
16152636|NCT01760005|Drug|Solanezumab|Intravenous infusion every 4 weeks at escalating doses
16152637|NCT01760005|Drug|Matching Placebo (Gantenerumab)|Subcutaneous injection of placebo every 4 weeks
16152638|NCT01760005|Drug|Matching Placebo (Solanezumab)|Intravenous infusion of placebo every 4 weeks
16152639|NCT01760005|Drug|Gantenerumab|Open-label administered Subcutaneously every 4 weeks at escalating doses
16152640|NCT01759992|Device|Threshold® Inspiratory Muscle Trainer (treatment).|Interval-based program consisting of seven cycles of 2-minutes work and 1-minute rest. The sessions will take place 3 times per week over a eight-week period for a total of 24 sessions. All participants were familiarized with the breathing exercises over a two-week familiarization period at the beginning of the protocol. The load will be adjusted at ≥ 50% of baseline MIP.
16152641|NCT01759979|Procedure|Laser and mechanical lithotripsy|Patients will undergo cholangioscopy guided laser treatment in addition to treatment with mechanical lithotripsy using basket and balloon techniques.
16152642|NCT01759979|Procedure|Mechanical Lithotripsy|Patients in the mechanical lithotripsy arm will undergo treatment only with basket and balloons to facilitate stone removal but not laser lithotripsy.
16152643|NCT01759953|Other|Game|InsuOnline game, on the web, in the player´s own time and rhythm
16152644|NCT01759953|Other|Traditional CME|In-classroom traditional learning session about insulin therapy for diabetes, using a presential short lecture and a group discussion of the same clinical cases presented in the InsuOnline game
16152645|NCT01759940|Drug|ropivacaine 0,375%|
16152646|NCT01759940|Drug|ropivacaine 0,75%|
16152647|NCT01759927|Behavioral|physical activity coaching|After measuring physical actity, physical fitness level, anthropometric and psychosocial variables a personalized 12 week physical activity program is made (=baseline). The intervention consisted of two face-to-face counselling sessions at the start of the intervention, short contacts by e-mail or telephone at weeks 3, 6 and 9, and two face-to-face counselling sessions at the end of the intervention. Employees exercise on their own. After 12 weeks and 6 months all measures are repeated.
16152648|NCT01759914|Drug|Potent topical steroid|
16152649|NCT01759914|Drug|Superpotent topical steroid|
16152650|NCT01759901|Procedure|Pringle|Vascular clamp is applied across hepatoduodenal ligament intermittently in 15 minutes on / 5 minutes off interval
16152651|NCT01759888|Drug|18F-DTBZ|"Subjects will receive a single i.v. administration of approximately 10 mCi 18F-FP-(+)-DTBZ (10 nmole FP-(+)-DTBZ) immediately prior to each scan.
~The proposed dose for this study is based on our phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG."
16152652|NCT01759875|Drug|Ritonavir-boosted Atazanavir|Ritonavir (100mg) PO x1 and Atazanavir (300mg) PO x1
16152653|NCT01759875|Drug|Ritonavir-boosted Atazanavir plus Rabeprazole|Rabeprazole (20mg) PO twice daily (Days 1-3); Ritonavir (100mg) PO x1 and Atazanavir (300mg) PO x1 (Day 4)
16152654|NCT01759875|Drug|Ritonavir-boosted Atazanavir plus Rabeprazole AND Betaine Hydrochloride|Rabeprazole (20mg) PO twice daily (Days 1-3); Betaine Hydrochloride (1500mg) PO x1 AND Ritonavir (100mg) PO x1 and Atazanavir (300mg) PO x1 on Day 4
16152655|NCT01759862|Drug|Aminophylline|Aminophylline loading dose 5mg/kg prior to transplant and will continue to receive aminophylline 1.8mg/kg Q6h for a total of 20 doses.
16152660|NCT01759823|Biological|mesenchymal stem cell transplantation|20 - 30 ml of bone marrow will be aspirated and layered on density gradient medium (Ficoll - hypaque ) and stem cells will be separated. Separated mono nucleated cells will be dissolved in minimum essential medium and inoculated in culturing flask and mesenchymal will be allowed to adhere to culturing flask and mesenchymal stem cell will be injected into superior pancreatic duodenal artery . Patients will be urged to monitor and document blood glucose readings for next 6 months. Glucagon stimulated C - peptide HYPERGLYCEMIC CLAMP FOR ASSESSMENT OF BETA CELL FUNCTION , Homeostasis Model of Assessment - Insulin Resistance and Beta cell function ,HbA1c, lipid profile and biochemistry will be done at baseline and 6 months .
16152661|NCT01759823|Other|control|5 ml of bone marrow will be aspirated and 3 mL of Vitamin B complex will be injected through transfemoral route into superior pancreatico-duodenal artery. Patients will be urged to monitor and document blood glucose readings for next 6 months. Glucagon stimulated C - peptide,HYPERGLYCEMIC CLAMP TO ASSESS BETA CELL FUNCTION. Homeostasis Model of Assessment - Insulin Resistance and Beta cell function ,HbA1c, lipid profile and biochemistry will be done at baseline and 6 months .
16152662|NCT01759823|Biological|MNC's TRANSPLANTATION|20 - 30 ml of bone marrow will be aspirated and layered on density gradient medium (Ficoll - hypaque ) and stem cells will be separated. Separated mono nucleated cells will injected into superior pancreatico duodenal artery. Patients will be urged to monitor and document blood glucose readings for next 6 months. Glucagon stimulated C - peptide HYPERGLYCEMIC CLAMP FOR ASSESSMENT OF BETA CELL FUNCTION , AND EUGLYCEMIC CLAMP TO ASSESS INSULIN SENSITIVITY .Homeostasis Model of Assessment - Insulin Resistance and Beta cell function ,HbA1c, lipid profile and biochemistry will be done at baseline and 6 months .
16152663|NCT01759810|Biological|Dendritic vaccine, allogeneic hematopoietic stem cells, cytotoxic lymphocytes|
16152664|NCT01759810|Biological|Dendritic vaccine, autologous hematopoietic stem cells, cytotoxic lymphocytes|
16152665|NCT01759797|Biological|intra venous injection of stem cell|Intra venous injection of mesenchymal stem cell
16152666|NCT01759784|Biological|Intraventricular injection|intraventricular injection of mesenchymal stem cell by stereo taxi in patients with ALS
16152667|NCT01759771|Drug|Vitamin D3|4,000 IU of VD3 for at least one year
16152668|NCT01759771|Drug|Placebo|Placebo for at least one year
16152669|NCT01759758|Other|Plaster Ulnar Gutter Splint|Patients are placed in a plaster ulnar gutter splint, molded in the safe position.
16152670|NCT01759758|Other|Thermoplastic Splint|Thermoplastic Splint is heat moulded to the patient's hand, stabilizing the metacarpal heads, but not immobilizing any joints. This is done by our occupational therapist.
16152671|NCT01759732|Drug|Fludarabine|40mg/M2 once daily IV on days -7 to -4
16152672|NCT01759732|Drug|Cyclophosphamide|60 mg/kg IV on day-3 and -2
16152673|NCT01759732|Biological|anti-thymocyte globulin|
16152674|NCT01759732|Biological|filgrastim|
16152675|NCT01759732|Radiation|Total body irradiation|200 cGy per day on D-5 & -4
16152676|NCT01759732|Procedure|CD3-depleted hematopoietic cell transplantation|Immunogenetic depletion on CliniMACS
16152677|NCT01759719|Device|coronary angioplasty with PtCr stent implantation|PCI with deployment of at least 1 PtCr stent
16152678|NCT01759706|Behavioral|Enhanced recovery after surgery protocol|ERAS items implemented were: preadmission counselling, preoperative immunonutrition, no preoperative bowel preparation, epidural analgesia, no pre-anesthetic medication, intraoperative iv fluid restriction, PONV and hypothermia prophylaxis, removal of nasogastric tube (NGT) at the end of surgery, mobilization protocol, solid food diet from POD 2, early stop of iv infusions and removal of urinary catheter.
16152679|NCT01759706|Procedure|Standard perioperative care|Epidural analgesia, pre-anesthetic medication with diazepam, bowel preparation with oral assumption of sodium phosphate, removal of nasogastric tube on POD 1, solid food diet from POD 4
16152680|NCT01759706|Drug|PONV prophylaxis with Ondansetron + Dexamethasone|Postoperative nausea and vomiting prophylaxis with Ondansetron + Dexamethasone.
16152681|NCT01759706|Other|Postoperative mobilization program|Patient mobilization for 2 hours on first postoperative day Patient mobilization for 4 hours on first postoperative day + assisted deambulation in the room Patient mobilization for 6 hours on first postoperative day + assisted deambulation in the ward
16152682|NCT01759706|Drug|Epidural analgesia with naropin + sufentanil|Midthoracic epidural analgesia with naropin 0.2 % plus sufentanil 0,5 mcg/mL
16152683|NCT01759706|Drug|Pre-anesthetic medication with diazepam|Premedication before general anesthesia
16152684|NCT01759706|Behavioral|Preadmission counselling|Patient multidisciplinary preoperative counselling, including anesthesiologist, surgeon and nurse.
16152685|NCT01759706|Drug|Preoperative bowel preparation with sodium phosphate|Preoperative bowel preparation with oral assumption of sodium phosphate
16152686|NCT01759693|Procedure|Blood sampling|Blood sampling
16152687|NCT01759680|Device|Vibrosphère device|Vertical Sinusoidal vibration
16152688|NCT01759667|Other|A standard mixed Meal|All patients underwent an indirect calorimetry test, after a 12-h period of fasting from food and water, avoiding intake of alcohol or coffee, and avoiding physical exercise and cigarettes the day before the examination. To examine possible changes in the thermogenic effect of food, patients received a standard mixed meal (200 ml coconut water and a chicken salad sandwich using whole wheat bread). They then repeated the test 20 min and 60 min after eating to obtain a reading of the metabolic rate by considering DIT and the RQ in the postprandial period.
16152689|NCT01759654|Biological|AdimFlu-V|
16152690|NCT01759641|Device|Hypotension-prone patients|Hemox optical sensor equips the dialysis monitors used during this trial. It is able to measure continuously, on arterial blood line, oxygen saturation, hematocrit and blood volume reduction.
16152691|NCT01759628|Drug|H.pylori eradication|The regimen consists of Omeprazole (20 mg/BD)+ Amoxicillin (1 g/day)+ Bismuth subcitrate (240 mg/BD)+ Azithromycin (500 mg/BD)for two weeks
16152692|NCT01759615|Other|Early Enteral feeding|Feeding with expressed breast milk @ 8ml/kg/day for 48 hrs after randomization at 60+/-12 hrs of life
16152693|NCT01759615|Other|Late enteral feeding|Nil per oral for another 48 hrs after randomization at 60+/-12 hrs of life followed by Feeding with expressed breast milk @ 8ml/kg/day for 48 hrs
16152694|NCT01759602|Drug|C1-esterase inhibitor (Cinryze)|
16152695|NCT01759589|Drug|Propofol|1 mg/kg propofol IV (over 15 sec) during anesthesia induction
16152785|NCT01758640|Drug|phenindione|Phenindione of 100mg or less per day
16152696|NCT01759589|Drug|Remifentanil and propofol|1 µg/kg IV (over 60 sec)remifentanil and 0.5 mg/kg propofol IV (over 15 sec)during anesthesia induction
16152697|NCT01759589|Drug|Sevoflurane|Sevoflurane was started at 6% for induction and continued at 1% until the electrical stimulus was delivered
16152698|NCT01759576|Drug|Canagliflozin (JNJ-28431754)|Volunteers in groups 1 through 4 will receive one 200mg tablet orally (by mouth) on Day 1. Volunteers in group 5 will receive one 200mg tablet orally on Day 1 (one hour after hemodialysis) followed, approximately 10 days later, by one 200mg tablet orally (2 hours before hemodialysis).
16152699|NCT01759563|Device|nasopharyngeal targeted brain cooling|
16152700|NCT01759537|Device|Ankylos dental endosseous implants-sub-crestal|Implants placed subcrestally
16152701|NCT01759537|Device|Ankylos dental endosseous implants-Epi-crestal|Implants placed Epi-crestally
16152702|NCT01759524|Drug|Bupivacaine|
16152703|NCT01759524|Drug|Lidocaine|
16152704|NCT01759511|Drug|Simtuzumab|200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
16152705|NCT01759498|Dietary Supplement|HYDRO|
16152706|NCT01759498|Dietary Supplement|ACTIVE|
16152707|NCT01759498|Dietary Supplement|HYDRO 2|
16152708|NCT01759485|Drug|Vitamin D3|once weekly oral drops preparation at a daily dose of 2000 IU X 7 = 14,000 IU per week (about 60 drops each week).
16152709|NCT01759485|Drug|placebo|
16152710|NCT01759459|Drug|Lidocaine|The medication will be administered immediately prior to receiving peripheral IV catheter placement
16152711|NCT01759459|Drug|Buffered Lidocaine|The medication will be administered immediately prior to receiving peripheral IV catheter placement
16152712|NCT01759459|Drug|Bacteriostatic Normal Saline|The medication will be administered immediately prior to receiving peripheral IV catheter placement
16152713|NCT01759446|Drug|Placebo taken first|Snorted in both nostrils within 5 minutes; 48 hours washout between doses
16152714|NCT01759446|Drug|Generic H/A taken first|Snorted in both nostrils within 5 minutes; 48 hours washout between doses
16152715|NCT01759446|Drug|Vycavert taken first|Snorted in both nostrils within 5 minutes; 48 hours washout between doses
16152716|NCT01759446|Drug|Generic H/A plus i taken first|Snorted in both nostrils within 5 minutes; 48 hours washout between doses
16152717|NCT01759446|Drug|Generic H/A plus p taken first|Snorted in both nostrils within 5 minutes; 48 hours washout between doses
16152718|NCT01759420|Drug|Ondansetron|4mg of intravenous ondansetron
16152719|NCT01759407|Drug|Ropivicaine|
16152720|NCT01759407|Drug|Epinephrine|
16152721|NCT01759394|Drug|Avatrombopag maleate 40 mg|"Avatrombopag maleate 40 mg (2 x 20 mg tablets- all doses are expressed as avatrombopag, the amount of free base) given with 240 mL water in three single oral doses, one during each of three treatment periods. Participants randomized to one of three treatment sequences:
~Fed, Fed, Fasted; or
~Fed, Fasted, Fed; or
~Fasted, Fed, Fed
~During the Fasted period, participants must have fasted for at least a 10-hour overnight fast and to refrain from eating for 4 hours.
~During the Fed period, participants were allowed approximately 30 minutes to eat a low-fat breakfast and required to take the drug within 15 minutes of completion of breakfast.
~Randomization Phase consists of three single-dose treatment periods:
~Treatment Period 1 and 2 separated by a 7-day washout interval. Treatment Period 2 and 3 separated by a 28-day washout interval. Treatment period 3 and the Follow-up/ Termination Visit will be separated by a 30-day (+1 day) washout interval."
16152722|NCT01759381|Device|Negative pressure wound therapy (NPWT)|
16152723|NCT01759368|Device|Telemonitoring assisted self-care|Telemonitoring group was given a home-care package including a weight scale, a blood pressure meter, a mobile phone and self-care instructions. The measurements taken at home to be uploaded were: diastolic and systolic blood pressure, pulse, body weight and an assessment of symptoms. The symptom assessment concerned the patient's feelings of dizziness, dyspnea, palpitation, weakness and, oedema. Patients were also asked to evaluate their overall condition- whether their condition had deteriorated, improved or remained unchanged. The patients were advised to carry out and report the measurements together with the self-assessment once a week. The responsible nurse followed patients' status and the data once a week or more frequently if needed. Based on the reported measurements, the nurse could invite the patient for a control visit. In case a patient did not make self-measurements as planned , the nurse contacted the patient and reminded him/ her to continue with monitoring
16152724|NCT01759355|Procedure|FDG PET/MR|Participants will undergo a FDG, gadolinium enhanced PET/MR scan.
16152725|NCT01759342|Behavioral|Aerobic exercise|
16152726|NCT01759342|Behavioral|Resistance exercise|
16152727|NCT01759342|Behavioral|Flexibility and postural exercise|
16152728|NCT01759342|Behavioral|Balance exercise|
16152729|NCT01759329|Dietary Supplement|test coffee|test coffee with higher alkyl pyridine content
16152730|NCT01759329|Dietary Supplement|control coffee|control coffee with regular alkyl pyridine content
16152731|NCT01759316|Other|heliox|heliox or oxygen is used in the two groups respectively
16152732|NCT01759303|Drug|pazopanib|"For subjects > 18 years of age and subjects 16-17 years of age with a BSA ≥ 1.6 Pazopanib 800mg once daily will be started on Cycle 1 Day 1 and will be administered continuously for each 28-day cycle. Subjects may continue study treatment until they develop disease progression or unacceptable toxicity.
~For subjects 16-17 years of age with a BSA < 1.6 m2, Pazopanib 600mg once daily will be started on Cycle 1 Day 1 and will be administered continuously for each 28-day cycle. Subjects may continue study treatment until they develop disease progression or unacceptable toxicity."
16152733|NCT01759290|Device|Absorb Bioresorbable Vascular Scaffold|Subjects receiving the Absorb Bioresorbable Vascular Scaffold
16152734|NCT01759277|Drug|Control: Femoral perineural local anesthetic infusion|The control group will receive a femoral nerve block and postoperative ropivacaine 0.2% infusion
16152735|NCT01759277|Drug|Experimental: Adductor Canal perineural local anesthetic infusion|The control group will receive an adductor canal nerve block and postoperative ropivacaine 0.2% infusion
16152736|NCT01759238|Drug|Capecitabine|825mg/m2 per os bid
16152737|NCT01759238|Drug|Bevacizumab|7.5 mg/kg
16152738|NCT01759238|Radiation|Radiotherapy|(conventional or intensity-modulated and image-guided radiotherapy)
16152739|NCT01759212|Biological|Allogeneic stem cells implantation|
16152741|NCT01759160|Procedure|Marsh Plasma TCI with high initial target|plasma target-controlled infusion in Marsh model(n=30) with an initial target concentration of 4 μg/ml. Target was then reset and gradually titrated to a sedation level with narcotrend index below 64.
16152742|NCT01759160|Procedure|Schnider Plasma TCI with high initial target|plasma target-controlled infusion in Schnider model(n=30) with an initial target concentration of 4 μg/ml. Target was then reset and gradually titrated to a sedation level with narcotrend index below 64.
16152743|NCT01759147|Procedure|Surgical treatment of acromioclavicular dislocation.|Coracoclavicular ligament repair using autogenous gracilis tendon implanted using an endobutton system containing fibrewires and a single transclavicular, transcoracoid bone tunnel.
16152744|NCT01759134|Other|Post discharge formula|Babies will be given either materna sensitive or similac neosure
16152745|NCT01759121|Radiation|T-PRP|532nm-short pulse panretinal photocoagulation with PASCAL function
16152746|NCT01759121|Radiation|S-PRP|532nm-partially subthreshold short pulse panretinal photocoagulation with PASCAL endpoint management function
16152747|NCT01759108|Drug|Rebamipide|Patients will be randomized 1:1 to receive either 300mg/d (100mg x3/day) of rebamipide or placebo for 12 weeks together with their usual therapy.
16152748|NCT01759095|Device|Electronic multidrug blister pack|At hospital discharge, patients will get their prescribed drugs repackaged in an electronic multidrug blister pack with 7x4 cavities. The electronic film affixed on the rear side measures the date and time when a loop is broken, i.e. when a cavity is emptied. Patients will get feedback on their adherence profiles at the community pharmacy.
16152749|NCT01759069|Procedure|Surgical treatment with microscope|
16152750|NCT01759056|Drug|AVX 470|active comparator
16152751|NCT01759056|Drug|Placebo|
16152752|NCT01759043|Procedure|guiding catheter|using a single transradial guiding catheter for coronary angiography and intervention
16152753|NCT01759043|Procedure|diagnostic catheter|diagnostic for coronary angiography and guiding catheter selection for intervention
16152754|NCT01759030|Drug|Rituximab|Patients will will receive rituximab a dose of 1000 mg , intravenously, slowly, once in 2 weeks, with 2 infusions per course (on day 1 and day 15).
16152755|NCT01759004|Other|volume, muscle strength, physical condition, BMI|phys. condition, muscle strength, volumetry, BMI
16152756|NCT01758991|Device|transcranial direct current stimulation (tDCS)|tDCS is a safe and painless transcranial stimulation that modulates brain activity and could improve stroke recovery. Electrodes in soaked sponges are placed over specific brain regions and held with an elastic band. Direct current is then applied through the electrodes. The patients may feel nothing or a slight tingling under the electrodes.
16152757|NCT01758978|Drug|a 60 mg dose of the hydrocodone bitartrate extended-release tablet administered as either two 30-mg tablets (Treatment A) or one 60-mg tablet (Treatment B).|Each subject will receive 1 treatment during each administration period. Subjects will receive each of the 2 treatments once. There will be a minimum 14-day washout period between the 2 administrations of study drug. Treatments will be orally administered to subjects, while they are seated, at approximately 0800 (±2 hours) on the 1st day of each administration period.
16152758|NCT01758965|Other|PPI|monotherapy of PPI
16152759|NCT01758965|Other|H2RA and surgicel|combination therapy of H2RA and surgicel
16152760|NCT01758913|Drug|Ibuprofen|To compare the efficacy, the side effects and the renal prostaglandin (PG) excretion between indomethacin and ibuprofen in extremely low birth weight (ELBW) infants.
16152761|NCT01758900|Device|CO2 insufflation regulator|The CO2 insufflation regulator is Olympus UCR(Olympus Optical Co., Ltd., Tokyo, Japan). The device connect the medical gas pipe joints and CO2 cylinders, then the CO2 gas will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE.
16152762|NCT01758900|Device|Air insufflation|The air will be pumped into the delivery tube which links to the water bottle until it insufflate the bowel through the SBE.
16152763|NCT01758874|Procedure|phlebotomy|repeated phlebotomy for 4 weeks
16152764|NCT01758861|Drug|EPO group|
16152765|NCT01758861|Drug|Placebo|
16152766|NCT01758835|Other|Splint 3 weeks|A removable orthosis/splint. Dynacast/Ortho-Glass AS (BSN Medical). Splint is used for 3 weeks and no additional support is used after splint removal.
16152767|NCT01758835|Other|Cast 3 weeks|A standard short boot cast from proximal tibia to MTP I-V joint line. Cast is made from 3M Scotchcast. Cast is removed after 3 weeks and no additional support is used after cast removal.
16152768|NCT01758835|Other|Cast 6 weeks|standard short boot cast from proximal tibia to MTP I-V joint line. Cast is made from 3M Scotchcast. Cast is changed after 3 weeks and removed after 6 weeks. No additional support is used after cast removal.
16152769|NCT01758822|Other|No endotracheal suction|Neonates in this group will be resuscitated without endotracheal suction in the initial steps of resuscitation.
16152770|NCT01758809|Procedure|Pre-emptive bupivacaine wound infiltration|Pre-emptive bupivacaine wound infiltration
16152771|NCT01758809|Procedure|intravenous patient controlled analgesia|postoperative pain control with intravenous patient controlled analgesia
16152772|NCT01758796|Procedure|Non-operative treatment|Below-the-knee cast for six weeks.
16152773|NCT01758796|Procedure|Surgery|Open reduction and internal fixation with 1/3 semi-tubular plate and screws.
16152774|NCT01758783|Drug|Glutamine|amino acid：1.2-2g/(kg·d) Glutamine：0.5g /(kg·d)
16152775|NCT01758757|Procedure|Vitrectomy|
16152776|NCT01758744|Drug|Inhaled Treprostinil Therapy|Treprostinil: Inhaled prostanoid therapy
16152777|NCT01758731|Drug|Olaparib|Olaparib PO (25, 50, 100 or 200 mg bid) in combination with RT and C225. BID, beginning three days prior to first C225 infusion and discontinued after RT completed.
16152778|NCT01758731|Drug|Cetuximab|Pre-RT cetuximab (C225), 400 mg/m²IV and weekly C225, 250 mg/m2 IV in during RT.
16152779|NCT01758731|Radiation|Radiation Therapy|RT to a total dose of 69.3 Gy (primary tumor and involved lymph nodes) in 33 fractions over 6 and 1/2 weeks
16152780|NCT01758718|Procedure|Eyelash line resection|Eyelash resection surgery was performed for entropion with Down's syndrome
16152781|NCT01758679|Biological|Licartin and CIK|Licartin and CIK
16152782|NCT01758666|Drug|Methotrexate,Calcium folinate|
16152783|NCT01758653|Other|No study intervention|There is no study-related intervention.
16152784|NCT01758640|Drug|Warfarin|Low dose warfarin of 5mg or less per day
16152786|NCT01758627|Drug|Peritoneal dialysis (PD)|PD exchanges will be customized depending on patient fluid status. At least one daily exchange of icodextrin PD solution will be provided to PD group.
16152787|NCT01758614|Procedure|bypass surgery|all participants in this group will be performed EC-IC bypass surgery
16152788|NCT01758614|Drug|Aspirin|all participants in this group will be given medical therapy including Aspirin 100mg per day or clopidogrel 75mg per day
16152789|NCT01758614|Drug|Clopidogrel|
16152790|NCT01758601|Other|Dietary intervention with 7 servings oh white fish per week (each serve consisted of 100g of frozen Namibia hake, Pescanova S.A., Pontevedra, Spain)|
16152791|NCT01758601|Other|Previous alimentary habits, avoiding any significant nutritional imbalance, as well as any fish or seafood|
16152792|NCT01758588|Drug|Peginterferon alfa-2a|50 mcg subcutaneous injection once per week
16152793|NCT01758562|Device|Caphosol|
16152794|NCT01758549|Other|Aggressive Intravenous Hydration Group|Patients in the intravenous hydration group wll be treated with lactated ringer infusion at a rate of 3cc/kg/hour during the procedure, be given a bolus of 20cc/kg immediately afterward and receive an infusion of 3cc/kg/hour for 8 hours after the procedure.
16152795|NCT01758549|Other|Standard Fluids Arm|Patients randomized to the standard fluids arm will receive lactated ringers at an infusion rate of 1.5cc/kg/hour during the procedure, will receive no bolus, and will receive an infusion of lactated ringers at 1.5cc/kg for 8 hours after the procedure.
16152796|NCT01758536|Drug|Huatuo Zaizao Pills|A tens of herbs botanical drug product 12 gram (g) in 72 mini pills formulation. It is to be used as 12 g each time, twice daily.
16152797|NCT01758523|Drug|Dutasteride|
16152798|NCT01758523|Drug|sugar pill|
16152799|NCT01758510|Genetic|HYNR-CS-Allo|The patients enrolled in the trial will be successively allocated into three cohorts for HYNR-CS-Allo inj., 0.25 X 10^6 cells/kg, 0.5 X 10^6 cells/kg, 1 X 10^6 cells/kg, according to the 3+3, up and down protocol design. The first treatment cohort will be 0.5 X 10^6 cells/kg dose cohort.
16152800|NCT01758497|Procedure|Fascia iliaca compartment block|30 ml 0.5% ropivacaine, beneath the fascia iliaca
16152801|NCT01758497|Procedure|Fascia Iliaca compartment block|30 ml 0.9% NaCl (sham block, SB), beneath the fascia iliaca
16152802|NCT01758484|Other|palliative care|Undergo supportive care intervention
16152803|NCT01758484|Other|questionnaire administration|Ancillary studies
16152804|NCT01758484|Procedure|quality-of-life assessment|Ancillary studies
16152805|NCT01758471|Drug|Glipizide|glipizide 5mg per pill 5mg tid p.o. for 3 month
16152806|NCT01758471|Drug|Acarbose|Acarbose 50mg per pill 100mg to 150mgtid p.o.（oral） for 3 month
16152807|NCT01758458|Biological|Aldesleukin|Given SC
16152808|NCT01758458|Other|Laboratory Biomarker Analysis|Correlative studies
16152809|NCT01758458|Biological|MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells|Given IV
16152810|NCT01758458|Radiation|Radiation Therapy|Undergo radiation therapy
16152811|NCT01758458|Biological|Recombinant Interferon Beta|Given intralesionally
16152813|NCT01758432|Combination Product|PRT064445/Apixaban|
16152814|NCT01758432|Combination Product|Placebo/Apixaban|
16152815|NCT01758432|Drug|Placebo|
16152816|NCT01758419|Radiation|Thallium-201 Myocardial Perfusion Study|One-day Tl-201 stress/rest MPI protocol with pharmacological stress, as daily practice will be applied. CZT camera with multipinhole collimator and stationary detectors scan heart simultaneously. A 10% symmetrical energy window at 140 keV was used. Electrocardiogram-gated scans will be applied. Perfusion images were reconstructed in standard axis and polar maps of the left ventricle were obtained. Scans from CZT was analyzed in consensus by two experienced readers blinded to any information on patient identification. The software package Myovation for Alcyone, QGS and QPS were used for quantitative analysis of MPI polar maps. Automated analysis to determine ejection fraction.
16152817|NCT01758406|Biological|Intracoronary injection|stem cell transplantation
16152818|NCT01758406|Biological|Intracoronary injection of Placebo|Injection of Placebo via coronary arteries in patients with heart failure.
16152819|NCT01758393|Drug|Prednisone|
16152820|NCT01758380|Drug|Vildagliptin|Patients will be instructed to take Vildagliptin tablets at a fixed dose of 50 mg twice daily (double blind therapy)
16152821|NCT01758380|Drug|Gliclazide|Patients will be instructed to take Gliclazide capsules at an equivalent dose to previous sulfonylurea in multiples of 80mg only (double blind therapy)
16152822|NCT01758380|Drug|Metformin|Patients in both arms will take Metformin at a dose between 1500mg-2500mg per day, in an open label fashion
16152823|NCT01758380|Drug|Placebo to Gliclazide|Patients will be instructed to take the Gliclazide matching placebo capsules at an equivalent dose to previous sulfonylurea in multiples of 80mg only (double blind therapy)
16152824|NCT01758380|Drug|Placebo to Vildagliptin|Patients will be instructed to take Vildagliptin matching placebo tablets at a fixed dose of 50 mg twice daily (double blind therapy).
16152825|NCT01758367|Drug|Deciatbine(DAC)|
16152826|NCT01758354|Other|Pompe disease newborn screening|DBS will be tested for acid alpha-glucosidase (GAA)activity. Newborns with low GAA activity will received a confirmatory blood sampling and clinical evaluation for the presence of cardiomyopathy.
16152827|NCT01758341|Procedure|Endoscopic radiofrequency ablation|Endoscopic radiofrequency ablation with the HabibTM EndoHBP catheter uses bipolar electrical energy for tissue coagulation and can be applied without any special patient preparation in the context of an endoscopic retrograde cholangiopancreatography (ERCP) examination to treat malignant biliary strictures.
16152828|NCT01758341|Procedure|Endoscopic retrograde cholangiopancreatography (ERCP)|ERCP is used to guide the RFA-catheter under radiological control to the location of the malignant stricture.
16152829|NCT01758341|Device|HabibTM EndoHPB catheter|"Used to apply radiofrequency energy to the malignant biliary stricture (see also intervention endoscopic radiofrequency ablation)"
16152830|NCT01758328|Drug|busulfan|
16152831|NCT01758328|Drug|melphalan|
16152832|NCT01758328|Drug|fludarabine|
16152833|NCT01758328|Biological|anti-thymocyte globulin (ATG)|
16152834|NCT01758328|Procedure|a T cell depleted stem cell transplant|
16152835|NCT01758315|Other|Training and in-office coaching|Participating practices will be coached to perform rapid, small-scale tests of change and to iteratively improve performance of problem-prone care systems, as well as to imbed simple measurement in routine daily work streams to guide improvement efforts. The sixteen intervention practices will serve as realistic research laboratories to help advance malpractice risk prevention and patient safety in specific areas by refining tools and strategies for smaller practices.
16152836|NCT01758302|Behavioral|Simple physical task|Participants are asked to complete a 1-time simple physical task that is not challenging nor novel (moving small objects across a room).
16152837|NCT01758302|Behavioral|Complex physical task|Participants are asked to complete a 1-time physical task that is low intensity but somewhat complex (involves a novel request to move objects in a way that is challenging and requires some coordination).
16152838|NCT01758302|Other|Cookies|Participants are asked to taste test chocolate chip cookies
16152839|NCT01758302|Other|Vegetables|Participants are asked to taste test raw celery or radishes
16152840|NCT01758302|Behavioral|No physical task|As a control, for 2 of the arms, participants are not asked to engage in a physical task
16152841|NCT01758263|Drug|Metoprolol|Metoprolol, oral administration
16152842|NCT01758263|Drug|Nebivolol|Nebivolol, oral administration
16152843|NCT01758250|Other|Acoustic Radiation Force Impulse (ARFI)|
16152844|NCT01758250|Other|Laser Doppler Flowmetry (LDF)|
16152845|NCT01758250|Other|Laser Doppler Perfusion Imaging (LDI)|
16152846|NCT01758250|Other|Optical Coherence Tomography (OCT)|
16152847|NCT01758250|Other|Orthogonal Polarization Spectral Imaging (OPSI)|
16152848|NCT01758250|Other|Nail fold video capillaroscopy (NVC)|
16152849|NCT01758237|Device|Neodymium-doped: Yttrium Aluminum Garnet (Nd:YAG) laser|This device is used to perform the peripheral iridotomy on all patients. It is a standard of care approved device.
16152850|NCT01758237|Procedure|Nd:YAG Laser Peripheral Iridotomy|After application of topical anesthetic to the eye undergoing the LPI, the patient is seated at the laser machine. Abraham iridotomy lens filled with a viscous material will be used to facilitate the procedure. The thinnest area of the iris quadrant treated will be chosen. Nd:YAG Laser will be applied until iridotomy is opened satisfactory.
16152851|NCT01758224|Other|Functional Magnetic Stimulation|The magnetic stimulation protocol (plan of study) consists of a daily expiratory (breathing out) muscle conditioning program (20 minutes). A magnetic coil will be placed on participant's back to stimulate the nerves related to the breathing function. Each stimulation will last two seconds and the time between each stimulation is about half a minute. The training session will begin with low intensity FMS for 20 minutes daily. The FMS stimulation intensity will gradually increase during the 6-week training period.
16152852|NCT01758224|Other|Resistive Expiratory Muscle Training|The REMT training will take place in the FMS lab using a standard resistive breathing device. After training, participants will perform the exercise for 20 minutes daily (5days each week for 6 weeks) in their home. Participants will wear a nose clip when performing the breathing exercise. The exercise protocol will begin with a low resistance level for 20 minutes a day. The resistance level will gradually increase during the 6-week training period.
16152853|NCT01758211|Procedure|fMRI Navigation AVM resection|intraoperative fMRI navigation guided resection in AVM patients
16152854|NCT01758211|Procedure|conventional resection|conventional resection in AVM patients
16152855|NCT01758198|Biological|Abatacept|
16152856|NCT01758198|Drug|Placebo matching with Abatacept|
16152857|NCT01758198|Drug|Methotrexate|
16152858|NCT01758185|Biological|recombinant hepatitis b vaccine|0.5ml intramuscular
16152859|NCT01758185|Biological|Aleph influenza vaccine|0.5ml intramuscular
16152860|NCT01758172|Drug|6% hydroxyethyl starch 130/0.4|
16152861|NCT01758172|Drug|Albumin|
16152862|NCT01758159|Dietary Supplement|Iron supplementation|
16152863|NCT01758159|Other|CFR|Complementary feeding with locally available foods according to optimized complementary feeding recommendation (CFR)
16152864|NCT01758146|Drug|Tamoxifen|20 mg once daily for 5 years
16152865|NCT01758146|Drug|Letrozole|Letroz, Femara, Letronat
16152866|NCT01758133|Behavioral|Exposure to medical clown activities|
16152867|NCT01758120|Drug|prednisone plus cyclophosphamide|"prednisone plus cyclophosphamide: prednisone(0.5mg/kg/day*6 months) plus cyclophosphamide(1g intravenous use,per 1 month*6months);
~supportive care,including ACE-I or ARBs and blood pressure control"
16152868|NCT01758120|Drug|Prednisone alone|"prednisone alone: prednisone(0.5mg/kg/day*6 months);
~supportive care,including ACE-I or ARBs and blood pressure control"
16152869|NCT01758107|Other|Withdraw cyclosporine|
16152870|NCT01758094|Drug|Sustanon 250 mg ampule (Testosterone esters)|Drug used for treatment of hypogonadism
16152871|NCT01758081|Dietary Supplement|vitamin D3|Vitamin D3 (cholecalciferol), 2000 IU per day
16152872|NCT01758081|Drug|omega-3 fatty acids (fish oil)|Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA])
16152873|NCT01758081|Dietary Supplement|Vitamin D3 placebo|
16152874|NCT01758081|Dietary Supplement|fish oil placebo|
16152875|NCT01758068|Procedure|Coconut Oil Application|Coconut oil - 4 ml
16152876|NCT01758055|Biological|Autologous MSCs transplantation|Autologous mesenchymal stem cells derived bone marrow, bronchoscopy
16152877|NCT01758042|Procedure|Haploidentical Bone Marrow/Kidney|Combined bone marrow and kidney transplantation using a haploidentical donor.
16152878|NCT01758029|Drug|testosterone undecanoate|treatment with testosterone undecanoate 1000mg intramuscular, at week 0, week 6, week 18.
16152879|NCT01757990|Dietary Supplement|Effect of Stevioside and Rebaudioside on plaque pH|After measuring baseline plaque pH, the subjects rinsed for 1 minute with the sucrose solution. Plaque pH was then measured at 5, 10, 15, 30, 45 and 60 min after the mouth rinse.
16152880|NCT01757977|Device|double lumen endotracheal tube placement and use|
16152881|NCT01757964|Biological|Bacteriotherapy|
16152882|NCT01757951|Procedure|Unimalleolar fixation|Medial malleolus is fixed first and after that ankle mortise stability is assessed using external-rotation stress test. If talocrural joint is stable after fixation of medial malleolus, the patient is randomized to unimalleolar fixation group and no fixation of the lateral side is performed.
16152883|NCT01757951|Procedure|Bimalleolar fixation|Medial malleolus is fixed first and after that ankle mortise stability is assessed using external-rotation stress test. If talocrural joint is stable after fixation of medial malleolus, the patient is randomized to bimalleolar fixation group i.e. additional fixation of the lateral malleolus fracture is performed.
16152884|NCT01757938|Procedure|Shang Ring Guided Circumcision|
16152885|NCT01757938|Procedure|Forceps Guided Circumcision|
16152886|NCT01757925|Behavioral|weight managment program|a comprehensive peditric weight management program consisting of 16 weekly group sessions
16152887|NCT01757925|Other|Active Gaming|partcipants will be given a gaming device and 2 games (1 at baseline and 1 at week 8)
16152888|NCT01757912|Procedure|cuff pressure|The patient will be positioned in 16 distinct body positions, immediately after correct positioning, the cuff pressure is measured during an end-expiratory ventilator hold.
16152889|NCT01757899|Drug|Methylprednisolone Arm|Day 0 - Loading dose 1 mg/kg IV bolus mixed in 5 mL NS (30 min) followed by continuous infusion Days 0 to 07 - 1 mg/kg/day mixed in 24cc NS and infused at 1 cc/hr Days 08 to 10 - 0.5 mg/kg/day mixed in 24cc NS and infused at 1 cc/hr Days 11 to 12 - 0.25 mg/kg/day Days 13 to 14 - 0.125 mg/kg/day
16152890|NCT01757899|Drug|Sterile Saline Arm|Patients randomized to the control arm will receive sterile normal saline in an amount that would equal the total diluted dose of study drug (ie. if initial loading dose equals a total of 24 cc [methylprednisolone + diluting fluid], then the patient will receive 24 cc of sterile normal saline). Tapering doses will be equivalent to that of the study arm, so that investigators will remain blinded to therapy. The unblinded party will be composed of the research ARDS pharmacist. Five days after the patient is able to ingest medications, placebo is administered per os (PO) in one single daily equivalent dose. The placebo will be manipulated by the pharmacist as to resemble identical to the active drug.
16152891|NCT01757886|Other|Biomarkers to analyze both intracoronary thrombi as blood|
16152892|NCT01757873|Drug|Z160|
16152893|NCT01757873|Drug|Placebo|
16152894|NCT01757860|Drug|CARD-024|Comparison of different dosages of drug
16152895|NCT01757860|Other|Drug Carrier|Drug Carrier, 20% ethanol:80% propylene glycol oral administered solution.
16152896|NCT01757847|Behavioral|Acceptance and Commitment Therapy (ACT)|The ACT group protocol consists of four 2-hour weekly sessions focusing on a) thoughts, feelings, and bodily sensations in the context of efforts to lose weight; b) limitations of efforts to control or eliminate negative thoughts or emotions, stress, or food cravings; c) changing expectations and goals from elimination of stress or cravings to living as well as possible with such feelings; d) mindfulness exercises to increase awareness; and e) identification of personal values and goals to achieve improved quality of life.
16152897|NCT01757847|Behavioral|Brief MOVE-II control group intervention|The MOVE-II protocol was designed to reinforce the weight-loss principles that patients learn in MOVE! and to provide support in continued weight loss. The brief MOVE-II active control group protocol will be delivered in four 2-hour weekly group sessions. This protocol includes a psycho-educational component that reinforces the key information from the medical, nutrition, and weight loss strategies modules of the MOVE! program. After review of the psycho-educational components, patients have the opportunity to share their challenges with binge eating and weight loss. Patients will then be able to receive support and feedback from other group members and the therapist. In addition to reinforcing the strategies taught during MOVE! and to provide support in implementing those strategies, the active control group focuses on increasing self-esteem and self-efficacy by exploring patient strengths and maintaining therapeutic alliance and optimism.
16152898|NCT01757834|Device|SWUS Elastography|
16152899|NCT01757821|Device|real 6-Hz primed low-frequency rTMS|10 minutes of 6-Hz stimulation (real priming) followed by 10 minutes of 1-Hz low-frequency stimulation delivered to the nonstroke primary motor region
16152900|NCT01757821|Device|Sham 6-Hz Primed low-frequency rTMS|10 minutes of sham priming stimulation followed by 10 minutes of 1-Hz low-frequency stimulation delivered to the nonstroke primary motor region
16152901|NCT01757821|Device|real 1-Hz rTMS only|20 minutes of low-frequency rTMS delivered to the nonstroke primary motor region
16152902|NCT01757808|Drug|Ranolazine|ranolazine sustained release at a dose of 500mg for one month followed by a dose of 1000mg.
16152903|NCT01757808|Drug|Placebo|placebo at a dose of 500mg for one month followed by a dose of 1000mg.
16152904|NCT01757795|Drug|SP-8203|SP-8203 injection at single ascending doses of 10 mg, 20 mg, 40 mg, 80 mg, 160 mg and 240 mg (optional) SP-8203 injection at multiple ascending doses for 7 days at least 2 dose levels below the MTD in the single ascending portion of the trial
16152905|NCT01757795|Drug|Placebo|Placebo will be intravenously administered
16152906|NCT01757782|Drug|Oral Sildenafil|Patients were randomized into two groups. Placebo was prepared with distilled water. In group A, newborns received oral Sildenafil solution through feeding tube which was prepared by crushing a 50 mg tablet of sildenafil in distilled water to make a concentration of 5 mg/ml. In group B, newborns received placebo. The protocol for dosing was (1) first dose of 1 mg/kg/dose within 30 minutes admission or within 12 hours of delivery (whichever earlier), (2) Dosing every six hours for a maximum of 8 doses, (3) Dose was doubled if the oxygenation index (OI) or SpO2 did not improve (If OI continued to be <10% of previous value and SpO2 was not increasing >5 of previous value) and blood pressure remained stable
16152907|NCT01757782|Drug|Placebo (distilled water)|Distill water oral
16152908|NCT01757769|Drug|Silodosin|8 mg daily for 24 weeks
16152909|NCT01757756|Drug|Pf-05175157|200-mg administered twice daily for 14 days
16152910|NCT01757756|Drug|placebo|placebo administered twice daily for 14 days
16152911|NCT01757756|Drug|midazolam|midazolam 3-mg admistered as single doses on Day 0 and Day 11.
16152912|NCT01757717|Radiation|Ir-192 high dose rate (HDR)|Patients will be followed at 2 months (+/- 2 weeks) post-treatment and then approximately every 3 months (+/- 2 weeks) until approximately 11 months of follow up. They will be evaluated for pain referable to the treated site, clinical and radiographic evidence of local progression, and treatment related toxicity. Thereafter, patients will be followed as clinically indicated.
16152913|NCT01757704|Procedure|Open pleurae & conventional filling of heart|After completion of the left heart surgery, the heart will be actively filled with blood from the cardiopulmonary bypass circuit and lungs fully ventilated with positive end-expiratory pressure to flush out all air trapped in the lung veins and left heart. When there is no more visible air seen on Trans-esophageal echocardiography, the patient is weaned from cardiopulmonary bypass.
16152914|NCT01757704|Procedure|Intact pleurae & staged filling of heart|After the end of the left heart surgery, the heart is gradually filled with blood from the cardiopulmonary bypass circuit. Cardiac contractions fill the lungs with blood til no more air is seen in left heart on Trans-esophageal Echocardiography. Thereafter the lungs are ventilated with 50% of the estimated lung minute volume and 5 cm positive end-expiratory pressure and cardiac filling and de-airing continued. If no air is seen in the left heart full ventilation is started and the patient is weaned from cardiopulmonary bypass.
16152915|NCT01757691|Drug|Fingolimod 0.5mg/daily|
16152916|NCT01757691|Drug|Placebo|
16152917|NCT01757678|Procedure|ICA (Invasive Coronary Angiography)|Per the protocol, patients will have an Invasive Coronary Angiography.
16152918|NCT01757678|Procedure|FFR (Fractional Flow Reserve)|Per the protocol, patients will have a Fractional Flow Reserve procedure.
16152919|NCT01757678|Procedure|cCTA (coronary computed tomography angiography)|Per the protocol, patients will have a coronary computed tomography angiography.
16152920|NCT01757678|Other|FFRct Analysis (Fractional Flow Reserve Computed Tomography)|Per the protocol, patients will have a fractional flow reserve computed tomography.
16152921|NCT01757665|Device|Edwards Aortic and Mitral Bioprostheses Models 11000A and 11000M|Implant of an aortic valve, Model 11000A or mitral valve, Model 11000M
16152922|NCT01757639|Biological|Ipilimumab|Given IV
16152923|NCT01757639|Other|Laboratory Biomarker Analysis|Correlative studies
16152924|NCT01757626|Biological|Hu3F8 With GM-CSF|Ph I: 1 cycle consists of treatment with hu3F8 for 3 days (day 1, 3 & 5). GM-CSF starts 5 days in advance of each hu3F8 cycle at 250 mcg/m^2/day (day -4 to day 0), & at 500 mcg/m^2/day x 5 days (day 1 to day 5). Hu3F8 cycles are 5 days. Ph II pts may receive treatment on a modified schedule of 3 doses of IV hu3F8 over a maximum of 10 days, as needed. With modified schedules of hu3F8, GM-CSF will be administered at 250 mcg/m2/day x5 days before the 1st dose of hu3F8, as with the standard schedule, but then GM-CSF at 500 mcg/m2/day will be administered on day of the 1st dose of hu3F8, on the day before and on the day of the 2nd dose of hu3F8, and on the day before and on the day of the 3rd dose of hu3F8. Cycles are repeated at 2-4 week intervals between 1st days of hu3F8, through 4 cycles. Pts who complete 4 cycles of treatment w/o complications or disease progression have the option of continuing treatment for up to 24 months from their 1st dose of hu3F8.
16152925|NCT01757626|Biological|Hu3F8 With GM-CSF|As determined by the phase I component of the study, the hu3F8 dosage in the phase II portion is 3 mg/kg/day. Patients who were treated in the phase I component are eligible for treatment in the phase II portion. Cycles are repeated approximately monthly through 5 cycles. Group 1 and Group 3 patients can continue to receive cycles every 1-2 months for up to 24 months from study enrollment or until they receive 5 cycles after a major response (CR or PR) is achieved, whichever comes first. If HAHA becomes (+), cycles are deferred until it becomes (-) again. Patients who develop HAHA which precludes timely treatments with hu3F8+GM-CSF are eligible to receive low-dose maintenance regimens such as irinotecan alone,61 temozolomide alone,62 irinotecan-temozolomide,63 or cyclophosphamide-topotecan.64 They can also receive anti-HAHA agents such as rituximab and cyclophosphamide. They resume treatment with hu3F8+ GM-CSF if HAHA becomes negative. Patients may receive local radiation therapy.
16152926|NCT01757613|Drug|AK 3012|cutaneous use twice a day
16152927|NCT01757600|Other|Microperimetry|
16152928|NCT01757587|Drug|Vildagliptin|50 mg, 2 tablets/day on 3 months, both periods of treatment
16152929|NCT01757587|Drug|Placebo|50mg 2 tablets / day on 3 months, both periods of treatment
16152930|NCT01757574|Drug|Alemtuzumab infusion|
16152931|NCT01757561|Procedure|propofol|use total intravenous anesthesia with propofol
16152932|NCT01757561|Procedure|sevoflurane|use inhalation anesthesia with sevoflurane
16152933|NCT01757548|Procedure|open operation|high ligation of spermatic vein by open operation
16152934|NCT01757548|Procedure|microsurgery|high ligation of spermatic vein by microsurgery
16152935|NCT01757535|Drug|Oral Azacitidine|300 mg oral azacitidine on days 1 to 14 of each 28-day treatment cycle.
16152936|NCT01757535|Drug|Placebo|Identically matching placebo tablets on days 1 to 14 of each 28-day treatment cycle.
16152937|NCT01757509|Other|Intervention group|"Participants will attend eight weeks of set dancing classes. Each class will be one and a half hours. Family members or volunteers will partner each participant with Parkinson's disease. The class will be led by a Chartered Physiotherapist who is also a set dancing teacher. Set dancing steps and sets will be thought and progressed in line with the participants' abilities. Frequent rests will be taken during the class.
~Participants will be given a home exercise programme which will involve mental rehearsal, listening to music, watching dance DVD's and practicing dance material in the seated position to reduce the risk of falling."
16152938|NCT01757496|Device|Cough Assist|
16152939|NCT01757457|Drug|Intracoronary administration of an abciximab bolus during primary PCI|Intracoronary administration of an abciximab bolus (reopro 0.25mg/kg) during primary PCI
16152940|NCT01757457|Drug|Intravenous administration of an abciximab bolus during primary PCI|Intracoronary administration of an abciximab bolus (reopro 0.25mg/kg) during primary PCI
16152941|NCT01757444|Device|BiPAP - A40|Patients receiving BiPAP AVAPS - AE ventilatory mode at home
16152942|NCT01757444|Device|BiPAP - ST|Patients receiving BiPAP- ST mode at home.
16152943|NCT01757431|Drug|Eculizumab|
16152944|NCT01757418|Drug|Immune Globulin Intravenous|A single dose of intravenous immune globulin or saline placebo administered within 24 hours of hospital presentation. The maximum dose in Phase I was 800 mg/kg. The dose for Phase II is 400mg/kg.
16152945|NCT01757418|Other|Normal saline|A single dose of normal saline administered within 24 hours of hospital admission for uncomplicated pain crisis.
16152946|NCT01757405|Biological|Recombinant Factor VIIa BI (rFVIIa BI)|Administered approximately every 3 hours as an intravenous bolus injection on-demand
16152947|NCT01757405|Biological|Recombinant Factor VIIa BI (rFVIIa BI)|Administered as a single intravenous bolus injection on-demand
16152948|NCT01757392|Biological|Candida albicans Skin Test Antigen|0.3 ml injected intralesionally monthly. Number of injections: until wart lesion is resolved or up to 6 injections.
16152949|NCT01757379|Dietary Supplement|13C-labeled Acetate|400 mg of sodium acetate 1-13C (2 colon delivery capsules with 200 mg)
16152950|NCT01757379|Dietary Supplement|13C-labeled propionate|340 mg of sodium propionate 1-13C (2 colon delivery capsules with 170 mg)
16153089|NCT01756365|Procedure|surgical transplantation of CECA|
16152951|NCT01757379|Dietary Supplement|13C-labeled butyrate|990 mg sodium butyrate 1-13C (2 colon delivery capsules with 495 mg)
16152952|NCT01757379|Dietary Supplement|Inulin|15 g of inulin dissolved in 200 ml of water
16152953|NCT01757366|Drug|Ginsenoside Rg3 plus First-line Chemotherapy|"Ginsenoside Rg3 20mg 2/day po,patients will receive Ginsenoside Rg3 until progression
~XELOX(oxaliplatin 130mg/m2 iv d1;capecitabine 1000mg/m2 po bid d1-14)every 3 weeks for 4 cycles followed by capecitabine until progression"
16152954|NCT01757366|Drug|First-line Chemotherapy|XELOX(oxaliplatin 130mg/m2 iv d1;capecitabine 1000mg/m2 po bid d1-14)every 3 weeks for 4 cycles followed by capecitabine until progression
16152955|NCT01757353|Behavioral|BASICS motivational interview|
16152956|NCT01757353|Behavioral|BASICS plus normative enhancement motivational interview|
16152957|NCT01757353|Behavioral|Self-directed: Information only|
16152958|NCT01757340|Behavioral|Weight loss with normal protein and leucine intake|Goal of 8 to 10% weight loss while consuming the recommended daily allowance of protein (i.e, 0.8 grams of protein per kg body weight per day).
16152959|NCT01757340|Behavioral|Weight loss with protein/leucine supplementation|Goal of 8 to 10% weight loss while consuming 150% of the recommended daily allowance of protein (i.e., 1.2 grams of protein per kg body weight per day) with the additional protein given in the form of whey protein, which has a high leucine content.
16152960|NCT01757327|Drug|Erismodegib|
16152961|NCT01757327|Drug|Placebo|
16152962|NCT01757314|Behavioral|ultrasound technique|instruction in the ultrasound technique
16152963|NCT01757314|Other|palpation technique|placement of a line via palpation technique
16152964|NCT01757301|Other|Assisted Symptom Management (ASM)|There will be 2 principal components to assisted symptom management (ASM): automated symptom monitoring, along with pain and mood self-management modules.
16152965|NCT01757301|Other|Comprehensive Symptom Management (CSM)|"This arm couples ASM with care management by a nurse-physician team, thus testing combined therapy vs. monotherapy (ASM only)."
16152969|NCT01757275|Drug|Esomeprazole Na|Given as 80mg bolus infusion during 30 min and then 8mg/h constant infusion during 71.5 hous
16152970|NCT01757275|Drug|Cimetidine|Given as 200mg bolus infusion during 30 min and then 60mg/h constant infusion during 71.5 hours
16152971|NCT01757275|Drug|Esomeprazole Mg|40 mg tablet once daily for 27 days
16152972|NCT01757262|Drug|90 mg Ticagrelor|Morning and Evening dose for 5 days
16152973|NCT01757262|Drug|75mg Clopidogrel|Morning dose for 5 days
16152974|NCT01757249|Drug|Combined Oral Contraceptive Pill (Microgynon 30)|Pre-IVF treatment for 8 weeks
16152975|NCT01757236|Drug|VANCOMYCIN|
16152976|NCT01757236|Drug|CEFTRIAXONE|
16152977|NCT01757236|Drug|CLINDAMYCIN|
16152978|NCT01757236|Drug|SULFAMETHOXAZOLE AND TRIMETHOPRIM (CO-TRIMOXAZOLE)|
16152979|NCT01757236|Drug|FLUOROQUINOLONE|
16152980|NCT01757236|Drug|LINEZOLID|
16152981|NCT01757236|Drug|RIFAMPIN|
16152982|NCT01757223|Biological|AdVEGF-All6A+|We will administer AdVEGF-All6A+, an adenovirus vector carrying the genetic material for human vascular endothelial growth factor to the ischemic myocardium of individuals with diffuse coronary artery disease.
16152983|NCT01757223|Biological|AdNull|AdNull is an adenovirus vector identical to AdVEGF-All6A+, except that it does not encode for a transgene.
16152984|NCT01757197|Drug|Toclizumab|8 mg/kg IV, once every 1-2 weeks. The maximum dose per infusion should not exceed 800 mg.
16152985|NCT01757184|Drug|Sebelipase Alfa|IV infusions of sebelipase alfa
16152986|NCT01757184|Drug|Placebo|IV infusions of matched placebo
16152987|NCT01757171|Drug|Cabazitaxel|20mg IV over 1 hour every 3 weeks
16152988|NCT01757158|Radiation|Cs-131 brachytherapy seeds|Cesium-131 is another radiation seed that may more effectively treat lung cancer patients. Cs-131 has been previously used in prostate cancer successfully. Cs-131 has similar energy to I-125 but has a much shorter half life (9days as compared to 60 days for I-125). Patients who receive Cs-131 radiation seeds are expected to be radioactive for 30 days (1 month) as compared to 180 days (6 months) with I-125.
16152989|NCT01757145|Drug|Eltrombopag|"From day +1, start eltrombopag 100 mg/d. If primary end point not reached on day +14, then from day +15 - 150 mg/d.
~If primary end point not reached on day +28 then from day +29 - 200 mg/d. If primary end point not reached on day +42 then from day +43 and on - 300 mg/d maximal dose).
~If present dose not tolerated, return to last tolerated dose. Eltrombopag will be discontinued after platelet count has exceeded 50,000/microliter for 14 consecutive days without administration of platelets. In case of decline of platelet count < 30,000/microliter within 15 days from eltrombopag discontinuation, it will be resumed for additional 4 weeks. After 4 weeks we will re-attempt to hold the drug (if the threshold of platelet count >50,000/microliter will be reached again)."
16152990|NCT01757132|Device|Implantable Miniature Telescope|Device - Implantable Miniature Telescope
16152991|NCT01757119|Drug|Tardyferon 80 mg|Oral administration (2 tablets)
16152992|NCT01757106|Drug|Xenon|general anaesthesia with xenon 50-60% in oxygen (FiO2=0.4-0.5)
16152993|NCT01757106|Drug|sevoflurane|general anesthesia with sevoflurane 1.4% in 50% oxygen/medical air
16152994|NCT01757093|Device|Automatic Tube Compensation plus CPAP|SPONTANEOUS BREATHING TRIAL WITH AUTOMATIC TUBE COMPENSATION plus CPAP
16152995|NCT01757093|Device|Continuous Positive Airway Pressure|SPONTANEOUS BREATHING TRIAL WITH CPAP
16152996|NCT01757080|Other|Cardiorespiratory performance assessment with ergospirometry test|
16152997|NCT01757080|Other|Biochemical analysis|
16152998|NCT01757067|Device|PVC ablation|This will compare symptoms, safety between ablation procedure vs medical therapy. Biosense Catheter used is not indicated specifically for PVC ablations and will be evaluated
16152999|NCT01757054|Dietary Supplement|ProNutrients Probiotic|Dosage is 1 individually wrapped packet (1 gram) containing probiotic powder per day for 21 days
16153000|NCT01757015|Drug|NVA237|NVA237 (50µg, o.d. via SDDPI) in the morning,
16153001|NCT01757015|Drug|Placebo to NVA237|Placebo to NVA237
16153090|NCT01756352|Drug|18F-FET|Radiotracer, surrogate marker for protein synthesis
16153091|NCT01756339|Drug|Solithromycin|
16153002|NCT01757002|Behavioral|Teens randomized to the experimental arm will receive 4 sessions plus a booster of web-based, tailored asthma management.|Web-based, computer-tailored asthma management intervention delivered in 4 sessions, plus a 6 month booster.
16153003|NCT01757002|Behavioral|Teens in the control group will receive generic, web-based asthma education.|Web-based, generic asthma management intervention delivered in 4 sessions.
16153004|NCT01756989|Drug|Thalidomide, etoposide, celecoxib|"Thalidomide p.o. 1 mg/kg/day/1; the dose is gradually escalated, the maximum dose being 6 mg/kg/day. (The individual dose is set based on adverse effects.) Celecoxib p.o. 230 mg/m2/day/1-2, or in small children at 7 mg/kg/day in 1-2 doses.
~Etoposide p.o. the initial dosage 20 mg/m2/day; the dose is gradually escalated, the maxi 70 mg/m2/day."
16153005|NCT01756976|Device|OrthoPat Advance|The device will be used initially in hysterectomy procedures. After a confirmation of product quality, the device will be used in routine orthopedic procedures.
16153006|NCT01756950|Biological|2 mg/kg CR8020|administered as a single 2-hour intravenous infusion
16153007|NCT01756950|Biological|5 mg/kg CR8020|administered as a single 2-hour intravenous infusion
16153008|NCT01756950|Biological|15 mg/kg CR8020|administered as a single 2-hour intravenous infusion
16153009|NCT01756950|Biological|30 mg/kg CR8020|administered as a single 2-hour intravenous infusion
16153010|NCT01756950|Biological|50 mg/kg CR8020|administered as a single 2-hour intravenous infusion
16153011|NCT01756950|Biological|Placebo|administered as a single 2-hour intravenous infusion
16153012|NCT01756937|Drug|Imotun|300.03mg/cap,orally, 1 capsule once daily for 24 weeks
16153013|NCT01756937|Drug|Placebo|1 capsule once daily for 24 weeks
16153014|NCT01756924|Drug|CEM-102|
16153015|NCT01756924|Drug|IV or Oral standard of care antibiotics|
16153016|NCT01756924|Drug|Rifampin|
16153017|NCT01756911|Device|MFM|Implantation of the MFM
16153018|NCT01756898|Drug|5 mg ASB17061|Oral administration of 5 mg ASB17061 taken once daily for 28 consecutive days.
16153019|NCT01756898|Drug|Placebo|Oral administration of placebo taken once daily for 28 consecutive days.
16153020|NCT01756898|Drug|10 mg ASB17061|Oral administration of 10 mg ASB17061 taken once daily for 28 consecutive days.
16153021|NCT01756898|Drug|20 mg ASB17061|Oral administration of 20 mg ASB17061 taken once daily for 28 consecutive days.
16153022|NCT01756885|Drug|Varenicline|Varenicline was used in accordance with FDA approved labeling: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).
16153023|NCT01756885|Drug|Placebo|On Day 85, participants randomized to standard therapy will be given placebo pills (resembling the 1.0mg pills),
16153024|NCT01756885|Behavioral|Smoking Cessation Counseling|"Behavioral Counseling (from Week 0 - Week 18)
~The counseling protocol was based on PHS guidelines for smoking cessation treatment (Fiore et al., 2008), used in our past studies with cancer patients (Schnoll et al., 2010a) and in our ongoing cessation trial at NU (R01 DA025078). Counseling is included given its efficacy at helping smokers quit (Fiore et al., 2008) and to increase study retention. Counseling is provided to both treatment arms through Week 18 to equate for time and attention across arms and since this method was used in varenicline clinical trials (Gonzales et al., 2006) and in our extended therapy trial (Schnoll et al., 2010b). In-person counseling was selected for most sessions to ensure adequate monitoring of participant safety and adherence throughout the trial."
16153025|NCT01756872|Procedure|Measurements of ovarian reserve|Blood test (AMH, E2, FSH) Ultrasound measurement of antral follicle count and ovarian volume
16153026|NCT01756859|Procedure|MRI Scan|
16153027|NCT01756846|Other|usual care|During 14 months, patients presenting with chest pain to the ED of participating hospitals will be included in the study. First, all hospitals will apply 'usual care' to all patients, i.e. risk assessment and subsequent management without application of the HEART score. Then, during a 14 month period, each 1,5 month 1 randomly allocated hospital will sequentially start to apply the HEART score in all chest pain patients (intervention period); during this intervention period patients with a HEART score 0-3 will not be admitted to the hospital, and patients with a HEART score above 3 will be treated according to current guidelines.
16153028|NCT01756846|Other|use of HEART risk score|During 14 months, patients presenting with chest pain to the ED of participating hospitals will be included in the study. First, all hospitals will apply 'usual care' to all patients, i.e. risk assessment and subsequent management without application of the HEART score. Then, during a 14 month period, each 1,5 month 1 randomly allocated hospital will sequentially start to apply the HEART score in all chest pain patients (intervention period); during this intervention period patients with a HEART score 0-3 will not be admitted to the hospital, and patients with a HEART score above 3 will be treated according to current guidelines.
16153029|NCT01756833|Drug|Doxycycline|100 mg po bid
16153030|NCT01756833|Drug|Placebo|capsule identical to the doxycycline capsule
16153031|NCT01756820|Procedure|Single-portal Endoscopic Carpal Tunnel Release (Microaire®)|SmartRelease® ECTR endoscopic carpal tunnel release system of MicroAire (http://www.microaire.com/products/ectr-endoscopic-carpal-tunnel/smart-release-ctrs/).
16153032|NCT01756820|Procedure|Knifelight|A mini-open single portal technique using the Knifelight® device (Stryker) according to the surgical technique as described by the manufacturer (antegrade approach)
16153033|NCT01756807|Device|The COMBO Stent|The COMBO Stent is developed basing on the GENOUS stent platform, and in addition, it also delivers a drug called sirolimus to the treated coronary blood vessel. The stent's original CD34 antibody coating is designed to promote healing of the coronary artery by catching circulating endothelial progenitor cells as they pass through the stent. These cells are naturally flowing in the circulation and are responsible for endothelial healing. This is intended to help the blood vessel wall heal over the stent more quickly and restore normal tissue function in the stented area. The combination of these two technologies in this new COMBO stent is expected to produce even better clinical results, which have been investigated in the previous REMEDEE Study.
16153034|NCT01756794|Procedure|Liver transplantation|
16153035|NCT01756781|Drug|Midazolam|Treatment A includes a single 2 mg oral dose of midazolam alone. Treatment B includes a single 2 mg oral midazolam dose on day 7 immediately after the day 7 PD-0332991 dose.
16153036|NCT01756781|Drug|PD-0332991|Treatment B includes 8 daily 125 mg oral doses of PD-0332991.
16153092|NCT01756339|Drug|Moxifloxacin|
16153093|NCT01756339|Other|Placebo to match solithromycin|
16153037|NCT01756781|Drug|Midazolam|"Treatment B includes a single 2 mg oral midazolam dose on day 7 immediately after the day 7 PD-0332991 dose.
~Treatment A includes a single 2 mg oral dose of midazolam alone."
16153038|NCT01756781|Drug|PD-0332991|Treatment B is made up of 8 daily 125 mg oral doses of PD-0332991.
16153039|NCT01756768|Radiation|[14C]-PD-0332991|A single 125 mg oral dose of PD-0332991 containing approximately 100 microcurie of [14C]-PD-0332991.
16153040|NCT01756755|Device|PMX-20R Hemoperfusion|Polymyxin B adsorbs and remove endotoxin from the patient's circulating blood.
16153041|NCT01756742|Other|Respiratory physiotherapy|"The respiratory physiotherapy intervention included:
~Mobilisation techniques: limb exercises (passive, active assisted, or active resisted)
~Chest physiotherapy: it included a Controlled breathing program, pursed lips breathing (PLB), active expiration and incentive spirometry."
16153042|NCT01756742|Other|Conservative treatment|Conservative medical treatment intervention for pleural effusion.
16153043|NCT01756729|Device|NovoTTF-100A|Multiple four-week courses of continuous NovoTTF-100A treatment.
16153044|NCT01756716|Drug|MT-3995 Low|MT-3995 Low dose for 8 weeks
16153045|NCT01756716|Drug|MT-3995 High|MT-3995 High dose for 8 weeks
16153046|NCT01756716|Drug|Placebo|Placebo for 8 weeks
16153047|NCT01756703|Drug|MT-3995 Low|MT-3995 Low dose for 8 weeks
16153048|NCT01756703|Drug|MT-3995 High|MT-3995 High dose for 8 weeks
16153049|NCT01756703|Drug|Placebo|Placebo for 8 weeks
16153050|NCT01756664|Other|Sunscreen|
16153051|NCT01756664|Other|Vaseline|
16153052|NCT01756651|Drug|Fentanyl pectin|comparison of Intranasal fentanyl 100mcg vs 200 mcg.
16153053|NCT01756638|Drug|Abiraterone|Abiraterone will be administered orally as 1000 milligram (mg) per day for 28-daily dosing cycles which will be continued until disease progression or unacceptable toxicity.
16153054|NCT01756638|Drug|Prednisolone|Prednisolone will be administered orally as 5 mg tablets twice daily for 28-daily dosing cycle which will be continued until disease progression or unacceptable toxicity.
16153055|NCT01756612|Drug|Methoxy Polyethylene Glycol-Epoetin Beta|Methoxy polyethylene glycol-epoetin beta will be administered at the discretion of treating physician. Study protocol does not specify any treatment regimen.
16153056|NCT01756599|Biological|blood samples|
16153057|NCT01756586|Drug|Dexamethasone|
16153058|NCT01756586|Drug|Bupivacaine|Control
16153059|NCT01756573|Drug|Dexamthsone|
16153060|NCT01756573|Drug|Bupivacaine|
16153061|NCT01756560|Drug|dexamethsone|
16153062|NCT01756560|Drug|Bupivacaine|
16153063|NCT01756547|Drug|Potassium Citrate|Potassium citrate, oral solution contains Tripotassium citrate monohydrate 20 grams, Citric acid monohydrate 4 grams, distilled water 40 ml, and simple syrup 100ml. The solution contained in a bottle of glass that contains 20 ml of 2 meq/ml of potassium and 2.5 meq/ml of citrate. The dose is 0,3ml/kg/day of the solution until the 38-40 weeks of corrected gestational age or unacceptable toxicity develops.
16153064|NCT01756547|Drug|Placebo|
16153065|NCT01756534|Device|SURGICEL|Surgicel® (Johnson and Johnson, New Brunswick, NJ, USA), an oxidized cellulose hemostatic agent, is indicated in surgical procedures as an adjunct to hemostasis when control of bleeding by ligature or other conventional procedures is ineffective or impractical.
16153066|NCT01756521|Drug|Moxifloxacin|
16153067|NCT01756508|Drug|eculizumab|Eculizumab 1200 mg/m2 will be administered once, 1 hour before graft reperfusion
16153068|NCT01756495|Drug|Losmapimod|Wet granulation formulation, Film coated white, 7 mm round, biconvex, plain faced Tablet of 7.5 mg or 10 mg unit dose strength. Taken orally 7.5 mg BID / 20 mg QD for 5 days in one of the 4 study periods
16153069|NCT01756495|Drug|Moxifloxacin|17.2mm x 7.1 mm capsule shaped pink biconvex tablet of 400 mg unit dose strength. Taken orally 400 mg on Day 5 in one of the 4 study periods
16153070|NCT01756495|Drug|Losmapimod matched Placebo|Direct compression formulation (visually matched to GW856553), Film coated white, 7 mm round, biconvex, plain faced Tablet. Taken orally for 5 days in one of the 4 study periods
16153071|NCT01756495|Drug|Moxifloxacin Placebo|16 mm x 8 mm capsule shaped to white film coated tablet. Taken orally for 5 days in one of the 4 study periods
16153072|NCT01756482|Drug|GS-5806|GS-5806, powder for oral solution
16153073|NCT01756482|Drug|Placebo|
16153074|NCT01756469|Behavioral|Behavioral Intervention for Alcohol Use|Behavioral Intervention for Alcohol Use
16153075|NCT01756456|Drug|rhNGF 10 μg/ml|rhNGF 10 μg/ml : one drop 6 times a day (one 35 μl drop equals to 0.35 μg of rhNGF)
16153076|NCT01756456|Drug|rhNGF 20 μg/ml|one drop 6 times a day (one 35 μl drop equals to 0.70 μg of rhNGF)
16153077|NCT01756456|Other|vehicle|ophthalmic solution of the same composition as the test product without rhNGF
16153078|NCT01756443|Drug|2% lidocaine/adrenaline and 0.5% bupivacaine|
16153079|NCT01756430|Drug|Carvedilol SR 32mg, QD|"Carvedilol SR 32mg QD for 4 weeks
~With the others investigation product placebo 1 capsule QD and 1 tablet BID for 4 weeks."
16153080|NCT01756430|Drug|Carvedilol SR 64mg, QD|"Carvedilol SR 64mg QD for 4 weeks
~With the others investigation product placebo 1 capsule QD and 1 tablet BID for 4 weeks."
16153081|NCT01756430|Drug|Carvedilol IR 25mg, QD|"Carvedilol IR 25mg QD for 4 weeks
~With the others investigation product placebo 2 capsules and 1 tablet QD for 4 weeks."
16153082|NCT01756430|Drug|Carvedilol IR 25mg, BID|"Carvedilol IR 25mg BID for 4 weeks
~With the others investigation product placebo 2 capsules QD for 4 weeks."
16153083|NCT01756417|Drug|Metformin|One 1,000 mg tablet of metformin taken orally (by mouth) on Day 1 and Day 8.
16153084|NCT01756417|Drug|Canagliflozin (JNJ-28431754)|Four 25 mg tablets of canagliflozin (JNJ-28431754) taken orally on Days 4 through 8.
16153085|NCT01756404|Drug|Canagliflozin (JNJ-28431754)|A 30mg/day, 100 mg/day, 300 mg/day, or 600 mg/day liquid dose administered once daily; a 300mg/day liquid dose administered in 2 divided doses (2x150 mg); or a 600 mg/day liquid dose administered in 2 divided doses (2x300 mg) using an oral (by mouth) liquid dispenser on Days 1 through 14.
16153086|NCT01756404|Drug|Placebo|Matching placebo (inactive medication) liquid dose(s) administered using an oral liquid dispenser once or twice daily on Days 1 through 14.
16153087|NCT01756378|Procedure|joint mobilization with movement|
16153088|NCT01756378|Procedure|traditional physical therapy program|I.R, stretching exercises, strengthen exercises
16153096|NCT01756313|Procedure|Laser+Methylaminolevulinat|It's a single arm study. Intervention as described in detailed description.
16153097|NCT01756300|Device|Celsius® ThermoCool® RD|The investigational device is designed to transmit radiofrequency (RF) current to the electrodes for ablation purposes, specifically for the treatment of resistant hypertension by renal denervation.
16153098|NCT01756287|Other|Chinese ocular exercise|A kind of massage around the acupuncture points around the eye.
16153099|NCT01756274|Device|Contour® NEXT BGMS|Lab professionals tested the BG concentration using Contour® NEXT BGMS (Blood Glucose Monitoring System). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method, Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN).
16153100|NCT01756274|Device|Contour® PLUS BGMS|Lab professionals tested the BG concentration using Contour® PLUS BGMS (Blood Glucose Monitoring System). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method, Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN).
16153101|NCT01756274|Device|Contour® Next EZ BGMS|Lab professionals tested the BG concentration using Contour® Next EZ BGMS (Blood Glucose Monitoring System). All meter BG results were compared with plasma results obtained with a reference laboratory glucose method, Cobas® 6000 instrument (Roche Diagnostics Corp., Indianapolis, IN).
16153102|NCT01756261|Drug|Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)|Patients treated with EYLEA under practical manner for AMD.
16153103|NCT01756248|Drug|Aflibercept(Eylea, VEGF Trap-Eye, BAY86-5321)|Patients treated with EYLEA under practical manner for AMD.
16153104|NCT01756209|Drug|Magnesium 400Mg|magnesium 400 mg + conventional treatment
16153105|NCT01756209|Drug|Ibuprofen 10 mg/kg|ibuprofen 10 mg/kg oral single dose
16153106|NCT01756209|Drug|acetaminophen 15 mg/kg|Acetaminophen 15 mg/kg oral single dose
16153107|NCT01756196|Drug|Spinal Steroid Injection|Steroid Injection
16153108|NCT01756183|Drug|S-1 + Paclitaxel Chemotherapy|"Dose of S-1: 60mg bid，Twice daily (after the breakfast and supper) for two weeks, and then suspend for one week.
~Dose of Paclitaxel: 150 mg/m2, iv, 3h, at D1"
16153109|NCT01756170|Drug|paclitaxel|
16153110|NCT01756170|Drug|cisplatin|
16153111|NCT01756170|Radiation|Radiotherapy|
16153112|NCT01756157|Biological|CINRYZE with rHuPH20|
16153113|NCT01756144|Device|rhBMP-2|
16153114|NCT01756131|Drug|GSK1265744 injectable suspension|200 milligram per milliliter sterile solution for injection
16153115|NCT01756131|Other|Placebo to match injectable suspension|placebo
16153116|NCT01756118|Drug|BEZ235|A minimum of 3 dose levels
16153117|NCT01756105|Drug|Metformin|Metformin: from 500 mg 2 time per day to 2500 mg per day; with increment of 500 mg every 5 days until abstention of
16153118|NCT01756105|Drug|Rapid acting analog insulin Intermediate acting NPH Insulin|Insulin therapy:If post meal (2 hours after meal) glycaemia is > to 120 mg/dl introduce Insulin rapid acting analog (Humalog*, Novorapid*) before the meal concerned and according to the weight. If weight is < 80 kg: breakfast 5U, lunch time 3U, and dinner 4U. If weight is > 80 kg :breakast 6U, lunch time 4U, dinner 5U.If post meal glycaemia stay over 120 mg/dl but lower than130 mg/dl: do 1 U more.If post meal glycaemia stay over 140 mg/dl : do 2 UI moreIf fasting glycaemia is over 95 mg/dl : introduce NPH Insulin (Umuline NPH*, insulatard*) before sleeping : 5U if weight is < 80 kg - 6U if weight is > 80 kgIf fasting glycaemia stay over 95 mg/dl increase NPH Insulin for 1 U and for 2 U if fasting glycaemia is over 110 mg/dl.
16153119|NCT01756092|Procedure|Autologous Fat Graft|Participants will receive an autologous fat graft to correct either a benign breast deformity or a post segmental mastectomy deformity.
16153120|NCT01756079|Drug|boceprevir|
16153121|NCT01756079|Biological|PegIFN-2b|
16153122|NCT01756079|Drug|RBV|
16153123|NCT01756066|Behavioral|Different levels of cost sharing|
16153124|NCT01756053|Drug|ABT-089|Selective neuronal nicotinic receptor agonist.
16153125|NCT01756053|Drug|Placebo|Matched placebo capsules supplied by study drug supplier.
16153126|NCT01756040|Drug|Lactulose -rhamnose solution|Measurement of intestinal permeability by use of mon- digestible sugars known not to cross the intestinal barrier in normal healthy intestinal tissue
16153127|NCT01756027|Device|Ulthera System providing one treatment per cheek|Focused ultrasound energy delivered below the surface of the skin per cheek.
16153128|NCT01756027|Device|Ulthera System providing two treatments per cheek|Focused ultrasound energy delivered below the surface of the skin
16153129|NCT01756001|Device|GlowCap|The main research instrument is an electronic pill bottle called GlowCaps (by Vitality) that has the ability to transmit adherence data to the Way to Health (WTH) web portal. The investigators will measure adherence by counting the number of properly taken doses during the final four weeks of the study. Each time the pill bottle is opened, a date- and time-stamped wireless signal is sent to the Vitality server via the AT&T cellular network which will then be uploaded to the Way to Health portal for aggregation.
16153130|NCT01756001|Behavioral|Daily email, text message, or phone call reminders|
16153131|NCT01756001|Behavioral|Paid for adherence|
16153132|NCT01755988|Other|Educational website (in addition to usual care).|
16153133|NCT01755988|Other|Website and interactive platform with telemonitoring.|
16153134|NCT01755975|Drug|Romidepsin|Romidepsin will be administered intravenously on days 1, 8, and 15 of a 28-day cycle.
16153135|NCT01755975|Drug|Lenalidomide|Lenalidomide will be taken orally daily for 21 days of a 28-day cycle.
16153136|NCT01755962|Other|Glycemic Load|
16153137|NCT01755962|Other|Resistance Training|
16153138|NCT01755949|Drug|Colchicine, 0.6 mg PO BID|Colchicine tablets will be over-encapsulated by the research pharmacy to be indistinguishable from placebo
16153139|NCT01755949|Drug|Matching placebo|Matching placebo tablets will be encapsulated by the research pharmacy to be indistinguishable from active drug
16153140|NCT01755936|Other|Cardiac Magnetic Resonance Imaging|For the evaluation of left ventricular volumes, function and mass. Also for the assessment of myocardial fibrosis based on the presence of delayed enhancement. Novel application of T1 mapping techniques will be evaluated.
16153141|NCT01755936|Other|Echocardiography|Assessment of aortic stenosis severity. Also evaluate diastolic and systolic function.
16153142|NCT01755936|Other|72 hour Holter Monitor|This will enable us to detect abnormal heart rhythms which may be associated with myocardial fibrosis
16153143|NCT01755923|Drug|Gefitinib|Gefitinib 250mg once per day until the progression disease or intolerant side effects
16153144|NCT01755923|Drug|Docetaxel|Docetaxel 75mg/m2 iv, d1,every 3 weeks, at least 2-6 cycles depending on the progression disease or the patient's physical condition
16153145|NCT01755910|Other|Left thoracic paravertebral block|
16153146|NCT01755910|Other|Right thoracic paravertebral block|
16153147|NCT01755897|Procedure|radical hysterectomy + pelvic lymph node dissection|
16153148|NCT01755897|Drug|Paclitaxel|135-175 mg/m(2) intravenously (IV) on day 1
16153149|NCT01755897|Drug|Cisplatin|75 mg/m(2) IV on day 2 and 3
16153150|NCT01755897|Drug|Cisplatin|35 mg/m(2) IV once a week
16153151|NCT01755897|Radiation|Pelvic RT|IMRT
16153152|NCT01755884|Dietary Supplement|Wheat oral immunotherapy|Cooked spaghetti
16153153|NCT01755871|Drug|Fingolimod|0,5mg Fingolimod once a day
16153154|NCT01755858|Drug|Bendavia|
16153155|NCT01755858|Drug|Placebo|
16153156|NCT01755845|Drug|paclitaxel|
16153157|NCT01755845|Drug|cisplatin|
16153158|NCT01755845|Radiation|radiotherapy|
16153159|NCT01755832|Procedure|Pool exercise|Group exercise in heated pool one hour per week for 12 weeks.
16153160|NCT01755819|Device|Biocomposite interference screw|
16153161|NCT01755819|Device|Extracortical ACL Tightrope fixation|
16153162|NCT01755780|Other|Left interscalene block|
16153163|NCT01755780|Other|Right interscalene block|
16153164|NCT01755767|Drug|Tivantinib|Tivantinib tablets
16153165|NCT01755767|Drug|Placebo|Matching placebo tablets
16153166|NCT01755754|Combination Product|Silicone Elastomer Vaginal Ring|Silicone Elastomer Vaginal Ring
16153167|NCT01755754|Device|Female Condom|Female condom
16153168|NCT01755741|Combination Product|Placebo Vaginal Ring|a silicone elastomer placebo vaginal ring, similar in composition to the dapivirine Ring-004 (which is currently used in IPM's ongoing Phase III program), except that it did not contain any active pharmaceutical agent, and a commercially available standard male latex condom with a silicone-based lubricant.
16153169|NCT01755741|Device|Condom|Male condom
16153170|NCT01755728|Drug|Paracetamol|Per gavage paracetamol 15 mg/kg every 6 hours, for up to 7 days.
16153171|NCT01755728|Drug|Ibuprofen|Per Gavage ibuprofen 10mg/kg x 3/d for up to 5 days Gold standard per literature
16153172|NCT01755728|Procedure|Closure of PDA|Open surgery for closure of PDA
16153173|NCT01755715|Procedure|Immediate IUD insertion|Insertion of LNG-IUD (Mirena) (at the same day to 3 days) after expulsion of placenta.
16153174|NCT01755702|Drug|Placebo|Placebo
16153175|NCT01755702|Drug|Experimental paracetamol + caffeine formulation|experimental paracetamol + caffeine formulation
16153176|NCT01755702|Drug|ibuprofen marketed formulation|ibuprofen marketed formulation
16153177|NCT01755702|Drug|Paracetamol marketed formulation|Paracetamol marketed formulation
16153178|NCT01755689|Biological|Meningococcal vaccine GSK134612|One dose administered intramuscularly (IM) in the deltoid of the right arm.
16153179|NCT01755689|Biological|Cervarix®|Three doses administered intramuscularly (IM) in the deltoid of the left arm.
16153180|NCT01755689|Biological|Boostrix®|One dose administered intramuscularly (IM) in the deltoid of the left arm.
16153181|NCT01755676|Drug|Orlistat 60 mg|1 tablet 3 times a day
16153182|NCT01755676|Other|Placebo|1 tablet 3 times a day
16153183|NCT01755663|Drug|Ivabradine and Metoprolol|
16153184|NCT01755650|Radiation|18F FPM|
16153185|NCT01755637|Drug|Albendazole|Albendazole tablets 400 mg
16153186|NCT01755624|Device|NovoTTF-100A device|
16153187|NCT01755624|Other|Best Standard of Care|
16153188|NCT01755611|Drug|Minocycline 100mg|Test product
16153189|NCT01755611|Drug|Minocycline 100mg|Reference product
16153190|NCT01755598|Biological|GSK Biologicals' investigational TB vaccine (GSK692342)|2 doses administered intramuscularly in the deltoid region of the arm.
16153191|NCT01755598|Biological|Placebo|2 doses administered intramuscularly in the deltoid region of the arm.
16153192|NCT01755572|Drug|Liraglutide|Single cross-over study, 1 arm starting with liraglutide for 3 weeks crossed-over to placebo for 3 weeks, and 1 arm starting with placebo with cross-over to liraglutide for 3 weeks.
16153193|NCT01755572|Drug|Placebo|Single cross-over study, 1 arm starting with liraglutide for 3 weeks crossed-over to placebo for 3 weeks, and 1 arm starting with placebo with cross-over to liraglutide for 3 weeks.
16153194|NCT01755559|Drug|Artesunate-amodiaquine|antimalarial ACT
16153195|NCT01755559|Drug|Dihydroartemisinin-piperaquine|antimalarial ACT
16153196|NCT01755559|Drug|Artemether-lumefantrine|antimalarial ACT
16153197|NCT01755546|Drug|EN3409|Open-Label Buprenorphine HCI Buccal Film at doses 300-900 mcg twice daily
16153198|NCT01755533|Other|Rural curriculum|Students in schools randomly assigned to this condition receive the rural version of the curriculum.
16153199|NCT01755533|Other|Classic curriculum|Students in schools randomly assigned to this condition receive the classic version of the curriculum.
16153200|NCT01755520|Drug|Ticagrelor|90mg twice daily dose
16153201|NCT01755520|Drug|Aspirin|Aspirin 100mg once daily
16153202|NCT01755520|Drug|Placebo - Ticagrelor|Placebo
16153203|NCT01755520|Drug|Placebo - Aspirin|Placebo
16153204|NCT01755507|Drug|norUDCA|Comparison of different dosages of norUDCA acid administered orally.
16153205|NCT01755507|Drug|Placebo|
16153206|NCT01755494|Drug|Saxagliptin 5 mg|Saxagliptin oral tablet 5mg, single dose
16153207|NCT01755494|Drug|Metformin XR 500 mg|Metformin XR oral tablet 500 mg, single dose
16153208|NCT01755494|Drug|Mertformin XR 2 x 500 mg|Metformin XR oral tablet 2 x 500 mg, single dose
16153209|NCT01755494|Drug|Komboglyze XR 5/500 mg|oral FDC tablet (saxagliptin 5 mg and metformin 500 mg), single dose
16153210|NCT01755494|Drug|Komboglyze XR 5/1000 mg|oral FDC tablet (saxagliptin 5 mg and metformin 1000 mg), single dose
16153211|NCT01755481|Other|Probiotic|
16153212|NCT01755481|Other|Whey protein concentrate|
16153213|NCT01755468|Drug|Intermittent insulin therapy|
16153214|NCT01755468|Drug|Continuous metformin|
16153215|NCT01755455|Drug|Ferrous sulfate 325mg|Ferrous sulfate 325mg tablet taken by mouth daily for 6 weeks
16153216|NCT01755455|Drug|Placebo|Matching placebo capsule
16153217|NCT01755442|Other|Placebo|Eligible subjects will be randomly assigned (1:1) to receive AMG 151 and matching placebo in 1 of 2 sequences over 2 treatment periods.
16153218|NCT01755442|Drug|AMG 151|Eligible subjects will be randomly assigned (1:1) to receive AMG 151 and matching placebo in 1 of 2 sequences over 2 treatment periods.
16153219|NCT01755416|Drug|Closed loop with sensor and Insulin|Subject will be on the closed loop device with enlite sensors for about 27 hours. They will not be on any study medication and will be on insulin alone.
16153220|NCT01755416|Drug|Closed loop with sensor, Insulin and Liraglutide|In this study visit the subject will be on the closed loop device with enlite sensors for about 27 hours. In addition to being on insulin, they would take a single injection of 1.2 mg of Liraglutide subcutaneously before dinner on Day 1.
16153221|NCT01755403|Drug|Benznidazole|
16153222|NCT01755390|Drug|Cabazitaxel (XRP6258)|Pharmaceutical form: infusion solution Route of administration: Intravenous
16153223|NCT01755377|Drug|Benznidazole|
16153224|NCT01755364|Biological|AdimFlu-V|
16153225|NCT01755338|Drug|Methylprednisolone|Methylprednisolone 15mg/kg
16153226|NCT01755338|Drug|Placebo|Placebo
16153227|NCT01755325|Drug|Compound realgar natural indigo Tablet|"Compound realgar natural indigo Tablet, 65mg/kg/d, from day1 to day14,every 4 weeks.
~imatinib,0.4g,qd"
16153228|NCT01755325|Drug|placebo|
16153229|NCT01755312|Device|Medication reminder|Medication reminder
16153230|NCT01755299|Other|"Regular 5-hour Energy"|Amount equivalent to the package commercially packaged and sold (1.93 fl. oz.)
16153231|NCT01755299|Other|"Decaf 5-hour Energy"|"Commercially available 5-Hour Energy Decaf product in the amount that is packaged (1.93 fl. oz.)"
16153232|NCT01755299|Other|Compounded concentrated caffeine liquid|"Concentrated caffeine liquid has been used to compound a 135 mg/2 ounce caffeine product, which contains the same amount of caffeine as a regular 5-hour Energy"
16153233|NCT01755299|Other|Flavored bottled water|Bottled water will be flavored and colored to serve as a placebo product for this trial.
16153234|NCT01755286|Drug|OTO-201|Single intra-operative injection
16153235|NCT01755286|Drug|Placebo|Single intratympanic injection
16153236|NCT01755286|Drug|Sham|Simulated single intratympanic injection
16153237|NCT01755273|Procedure|Pancreaticoduodenectomy with more distal enteral bypass|Patients undergoing pancreaticoduodenectomy, the enteral bypass (gastrojejunostomy/duodenojejunostomy is extra 100 cm away from standard bypass )
16153238|NCT01755260|Other|Jejunostomy tube feeding|The patients at this arm receive the nutritional support through the feeding jejunostomy tube; they can only eat or sip water through mouth
16153239|NCT01755247|Drug|Topical Gel Vehicle|
16153240|NCT01755247|Drug|8% NVN1000 Topical Gel|
16153241|NCT01755247|Drug|8% NVN1000 Topical Gel and moisturizer|
16153242|NCT01755234|Drug|Sevoflurane|Sevfoflurane inhaled administered by laryngeal mask airway or endotracheal tube
16153243|NCT01755234|Drug|Propofol|Propofol administered via intravenous catheter at an initial rate of 1.0 -2.0 mg/kg then the Propofol infusion rate will be titrated to keep a bispectral index between 40-60
16153244|NCT01755221|Other|Single-center prospective evaluation of the Restech pH probe|All subjects will have a pH probe placed at their initial clinic visit and will have the probe removed 24 hours later. They will start on PPI medication (as per the standard of care) after probe removal. Subjects will have a follow up clinic visit 8-12 weeks after the initial visit. At the follow up visit, all subjects will have the option of a second probe placement to assess the effects of PPI therapy on reflux events.
16153245|NCT01755208|Procedure|light-scattering spectroscopy|Undergo light-scattering spectroscopy
16153246|NCT01755195|Drug|Cabozantinib|Cabozantinib inhibits multiple receptor tyrosine kinases (RTKs) implicated in tumor growth, metastasis, and angiogenesis, and targets primarily mesenchymal-epithelial transition factor (MET) and vascular endothelial growth factor receptor 2 (VEGFR2).
16153247|NCT01755182|Drug|approved pharmacologic therapy|
16153248|NCT01755182|Procedure|TAE|after randomization, and after 3 months
16153249|NCT01755169|Drug|Ketamine|Participants on active treatment are given ketamine orally for 2 weeks, at varying dosages (1 dosage per participant).
16153250|NCT01755169|Drug|Placebo|
16153251|NCT01755156|Drug|Omarigliptin|Omarigliptin 25 mg capsule administered orally once weekly (preferably on the same day of each week)
16153252|NCT01755156|Drug|Matching placebo to omarigliptin|Matching placebo to omarigliptin capsule administered orally once weekly (preferably on the same day of each week)
16153253|NCT01755156|Drug|Glimepiride|Glimepiride 1 or 2 mg tablet/capsule administered orally once daily and up-titrated to a maximum dose of 6 mg daily. Participants rescued with open-label glimepiride during Phase A will not receive glimepiride or matching placebo to glimepiride during Phase B.
16153254|NCT01755156|Drug|Matching placebo to glimepiride|Matching placebo to glimepiride tablet/capsule administered orally once daily and up-titrated to a mock maximum dose of 6 mg daily. Participants rescued with open-label glimepiride during Phase A will not receive glimepiride or matching placebo to glimepiride during Phase B.
16153255|NCT01755156|Drug|Insulin glargine|During Phase B of the study, participants who received a maximum up-titration of open-label glimepiride or blinded glimepiride/matching placebo to glimepiride, may be rescued with open-label insulin glargine.
16153256|NCT01755156|Drug|Metformin|Participants continue stable pre-study dose of metformin tablet(s) administered orally (>= 1500 mg daily) throughout the study.
16153257|NCT01755143|Other|Magnetic Resonance Imaging scan sequences of the head, neck, and chest|
16153258|NCT01755143|Device|Pacemaker System|
16153259|NCT01755130|Procedure|Photoacoustic Imaging|Undergo LOUISA 3D
16153260|NCT01755117|Other|Sciatic, femoral, obturator nerve blocks|
16153261|NCT01755117|Other|Sciatic nerve block, posterior lumbar plexus block|
16153262|NCT01755104|Dietary Supplement|Stablor|
16153263|NCT01755104|Dietary Supplement|Placebo|
16153264|NCT01755091|Drug|Dronabinol|
16153265|NCT01755091|Drug|Placebo (for Dronabinol)|
16153266|NCT01755078|Drug|Sevelamer HCl|Non-metal phosphate binder
16153267|NCT01755078|Drug|Calcium-based phosphate binder|
16153268|NCT01755026|Drug|cefazolin|2 gram dose for pre-operative prophylaxis
16153269|NCT01755026|Drug|cefazolin|4 gram dose for pre-operative prophylaxis
16153270|NCT01755013|Procedure|Photodynamic Therapy|Photofrin and Photodynamic therapy using the plastic optic diffuser, conducted during Standard of care Endoscopic retrograde cholangiopancreatography (ERCP)
16153271|NCT01755000|Procedure|USCOM scan|
16153272|NCT01755000|Procedure|Fluid Bolus|
16153273|NCT01754987|Drug|Ascorbic Acid + Sorafenib|
16153274|NCT01754987|Drug|Sorafenib|
16153275|NCT01754974|Biological|Peginterferon Lambda-1a|
16153276|NCT01754974|Drug|Ribavirin|
16153277|NCT01754974|Biological|Peginterferon alfa-2a|
16153278|NCT01754961|Drug|Vitamin D|Vitamin D 500,000 IU given orally on Day 1
16153279|NCT01754961|Drug|Placebo|Placebo given orally on Day 1
16153280|NCT01754935|Drug|VX-509|50 mg oral tablet
16153281|NCT01754935|Drug|VX-509 matching placebo|0 mg oral tablet
16153282|NCT01754909|Drug|Enalapril|Enalapril once a day, orally, as 2.5 , 5, or 10 mg tablets to be given in escalating doses, to subjects undergoing radiotherapy for lung cancer
16153283|NCT01754909|Drug|placebo|Placebo, once a day, orally, as 2.5 , 5, or 10 mg tablets to be given in escalating doses, to subjects undergoing radiotherapy for lung cancer
16153284|NCT01754896|Other|mailing of FIT kit directly to patient|Patient receives a mailed invitation to participate in CRC screening, with a FIT screening kit included.
16153285|NCT01754896|Other|mailed invitation to pick up lab requisition and then kit|Patients receives a mailed invitation to visit their physician to discuss CRC screening. At that visit, they would receive a FIT laboratory requisition, which they will take to a local lab patient service centre to pick up a FIT kit.
16153286|NCT01754896|Other|mailing completed kits in for processing|Patients mails completed kit in for processing using postage-paid reply envelope provided.
16153287|NCT01754896|Other|dropping completed kits at lab for processing|Patient takes completed FIT in to lab patient service centre for processing.
16153288|NCT01754883|Drug|Lithium Carbonate|Oral Lithium carbonate to target serum levle of 0.6-0.8.
16153289|NCT01754870|Drug|Bendamustine and Rituximab Induction followed by Rituximab and Lenalidomide Maintenance|
16153290|NCT01754857|Drug|Bendamustine|Given IV
16153291|NCT01754857|Drug|Rituximab|Given IV
16153292|NCT01754857|Drug|Lenalidomide|Given PO
16153293|NCT01754844|Drug|AZD7624|Single dose inhaled IMP via a nebulizer
16153294|NCT01754844|Drug|Placebo to match|Single dose inhaled Placebo via a nebulizer
16153295|NCT01754831|Device|Fluoride varnish|Topical application of fluoride varnish on present teeth
16153296|NCT01754818|Drug|Bendavia 10mg|
16153297|NCT01754818|Drug|Bendavia 50mg|
16153298|NCT01754818|Drug|Bendavia 100mg|
16153299|NCT01754818|Drug|Placebo|
16153300|NCT01754805|Drug|peficitinib|oral
16153301|NCT01754805|Drug|methotrexate|oral
16153302|NCT01754792|Dietary Supplement|Pinitol|Fruit Up® (diluted with mineral water to a final volume of 250 ml) will be evaluated, and will be equivalent to an intake of 2 g of pinitol. The placebo beverage will contain equal amounts of non-polyol carbohydrates with similar macronutrient composition and energy intake as that those obtained through the pinitol beverage, but excluding pinitol.
16153303|NCT01754779|Drug|Placebo|Matching placebo for both aims.
16153304|NCT01754779|Dietary Supplement|Citric Acid|
16153305|NCT01754779|Dietary Supplement|Potassium Citrate|
16153306|NCT01754779|Drug|Indapamide|Aim 2
16153307|NCT01754766|Drug|AGN-229666|One drop of AGN-229666 into each eye on Day 1 and Day 15.
16153308|NCT01754766|Other|vehicle of AGN-229666|One drop of vehicle of AGN-229666 into each eye on Day 1 and Day 15.
16153309|NCT01754753|Other|Telephone Friendship groups|
16153310|NCT01754740|Drug|Uréia|"The subjects were randomly divided into two groups:
~1. Study Group: 19 patients received topical medication of urea 10% to be applied at the oral cavity 3-4 times per day, during three months."
16153311|NCT01754740|Drug|Placebo|Control Group: 19 patients received placebo (5% sodium carboxymethylcellulose, 0.15% methyl paraben and 10% glycerol in distilled water qsp 100g) to be applied at the oral cavity 3-4 times per day, during three months.
16153312|NCT01754714|Drug|SAMe 1000 mg|1000 mg dose group: one 500 mg capsule fasting in the morning and one 500 mg capsule before dinner
16153313|NCT01754714|Drug|SAMe 1500 mg|1500 mg dose group: two 500 mg capsules fasting in the morning and one 500 mg capsule before dinner
16153314|NCT01754714|Drug|SAMe 2000 mg|2000 mg dose group: two 500 mg capsules fasting in the morning and two 500 mg capsules before dinner
16153315|NCT01754701|Dietary Supplement|Immediate iron|Children who start 4 weeks of iron therapy on Day 0
16153316|NCT01754701|Dietary Supplement|Delayed iron|Children who start 4 weeks of iron therapy on Day 28
16153317|NCT01754675|Behavioral|Soccer|Watching the soccer match at the time that the favorite team is playing
16153318|NCT01754675|Behavioral|Movie|Watching a movie at the time that the favorite team is playing
16153319|NCT01754662|Dietary Supplement|Soy protein|2 bars daily for 8 weeks.
16153320|NCT01754662|Dietary Supplement|Isoflavones|2 bars daily for 8 weeks.
16153321|NCT01754662|Dietary Supplement|Cocoa|2 bars daily for 8 weeks.
16153322|NCT01754662|Dietary Supplement|Placebo|
16153323|NCT01754649|Drug|Misoprostol|The study group will receive two doses of misoprostol (200mcg each tablet) vaginal 12 and 4 hours prior insertion. After 24 hours of the insertion failure the women will return to the clinic and a new attempt of insertion will be done. At this time we will evaluate if the insertion was able to do or not.
16153324|NCT01754636|Other|No intervention|
16153325|NCT01754623|Drug|Capecitabine|Treatment will begin with the first round of chemotherapy. Each round of chemotherapy will take 21 days. Each round or cycle will start with participants taking capecitabine pills. Participants will take tablets of capecitabine (Xeloda®) twice per day for 14 days followed by 7 days without capecitabine.
16153326|NCT01754623|Drug|Gemcitabine|On the fourth day of the cycle, participants will be treated with gemcitabine and docetaxel. First, this will consist of placing gemcitabine (Gemzar®) in a bag of fluid and giving it by vein over 30 minutes.
16153400|NCT01753947|Other|Deliberate Practice|
16153327|NCT01754623|Drug|Docetaxel|On the fourth day of the cycle, participants will be treated with gemcitabine and docetaxel. After the gemcitabine, participants will receive docetaxel (Taxotere®) in a bag of fluid over 1 hour.
16153328|NCT01754623|Radiation|Stereotactic body radiation therapy (SBRT)|30/40 Gy to pancreatic tumor/area of borderline resectability
16153329|NCT01754623|Other|Restaging review after radiation|After radiation, participants will be re-evaluated for surgery. Patients who have Complete Response (CR), Partial Response (PR) or stable disease (SD) will proceed with surgical exploration and resection provided they are suitable fit for surgery in the judgment of the surgical oncologist. Patients who have local progression on imaging scan will be offered conventional 5-Fluorouracil based intensity-modulated radiation therapy (IMRT). If no surgery: then chemotherapy. If surgery: chemotherapy will be given based on response.
16153330|NCT01754623|Procedure|Surgery|Non-metastatic patients who are deemed resectable after neoadjuvant therapy will be taken to surgery. After surgery, chemotherapy will be given based on response.
16153331|NCT01754623|Drug|5-Fluorouracil|Patients who have local progression on imaging scan will be offered conventional 5-Fluorouracil based intensity-modulated radiation therapy (IMRT).
16153332|NCT01754610|Behavioral|Strengthening Family Coping Resources (SFCR)|"Trauma Version (15 weeks) and High Risk Version (10 weeks) are 2 hour sessions. Dinner will be provided at the start of group for all participants.
~Activities will be conducted at each group to encourage family involvement. The treatment modules focus on family rituals and routine, strengthening families' collaborative coping, and resolution of the trauma(s) bringing the families to treatment. Activities will be both family-based and age-based."
16153333|NCT01754597|Drug|Peptide Natriurétique de type B|Peptide Natriurétique de type B
16153334|NCT01754571|Behavioral|Cognitive behavior therapy|Behavior therapy, including Relaxation, cognitive rebuilding.
16153335|NCT01754558|Procedure|Ajust system|The use of Ajust system for stress incontinence
16153336|NCT01754558|Procedure|TVT/TVT-O|sling surgery
16153337|NCT01754545|Drug|Octaplas infusion and placebo (group 1)|Intervention period is Monday-Friday in two following weeks. Active treatment with Octaplas is given 2-3 times each week and placebo is given the other 2-3 days of intervention each week. Route of administration is intravenously.
16153338|NCT01754545|Drug|Octaplas infusion and placebo (group 2)|Intervention period is Monday-Wednesday in two separate weeks (minimum of three weeks between intervention weeks). Active treatment with Octaplas is given once and placebo is given twice each week. Route of administration is intravenously.
16153339|NCT01754532|Biological|Hair Sample|Analysis of hair cortisol levels
16153340|NCT01754519|Procedure|Therapeutic Conventional Surgery|Undergo wide local excision breast surgery
16153341|NCT01754519|Radiation|Radiation Therapy|Undergo SFRT
16153342|NCT01754519|Other|Laboratory Biomarker Analysis|Correlative studies
16153343|NCT01754519|Other|Quality-of-Life Assessment|Ancillary studies
16153344|NCT01754506|Dietary Supplement|Fish Oil|EPA + DHA Group subjects (n=54) will be given n-3 fatty acid supplement softgels
16153345|NCT01754493|Drug|Duloxetine|This study is a 12-week open trial to assess the efficacy of duloxetine (Cymbalta) for the treatment of Irritable Bowel Syndrome (IBS) symptoms and comorbid Major Depressive Disorder (MDD). Participants will visit the clinic 8 times to meet with the psychiatrist. They will receive duloxetine to see if it helps their major depression and Irritable Bowel symptoms.
16153346|NCT01754480|Biological|Fibrin Sealant Grifols|Combination of 3 mL fibrinogen and 3 mL thrombin, in separate syringes assembled on a syringe holder (6 mL of solution in total), applied topically to the target bleeding site.
16153347|NCT01754480|Device|Surgicel®|Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
16153348|NCT01754467|Behavioral|NEAT!|Participants will wear the accelerometer and use the NEAT! application during waking hours for 1 month. The NEAT! app will prompt participants to stand up when they have been sitting for a prolonged period.
16153349|NCT01754454|Biological|Human Umbilical Cord Derived MSC|1×10^6 UC-MSCs per kg intravenous injection the number of infusions: once a week, for four weeks in a row Time interval: estimate the condition of follow-up visit afer 28 days
16153350|NCT01754415|Device|hydraulic resistance circuit training|12 weeks (3 times per week, 40 min circuit) of hydraulic resistance circuit training that consisted of 10 types of equipments for different part of strength training.
16153351|NCT01754402|Drug|Bendamustine|Bendamustine will be administered intravenously over 1 hour (if using Treanda) or over 10 minutes (if using Bendeka) on day 1, every 28 days for 12 cycles.
16153352|NCT01754402|Drug|Pomalidomide|Pomalidomide will be administered once daily orally (PO) on days 1-21, every 28 days until disease progression or death.
16153353|NCT01754402|Drug|Dexamethasone|Dexamethasone will be administered weekly orally or intravenously on days 1, 8, 15, and 22 every 28 days until disease progression or death. After 6 cycles of treatment, the dose may be reduced to 20mg at investigator's discretion. For subjects ≥ 75 years of age, the starting dose of dexamethasone is 20 mg/day on Days 1, 8, 15 and 22 of each 28-day treatment cycle.
16153354|NCT01754389|Drug|Tacrolimus|
16153355|NCT01754389|Drug|Methotrexate|
16153356|NCT01754389|Drug|Bortezomib|
16153357|NCT01754389|Drug|Sirolimus|
16153358|NCT01754376|Drug|Aldesleukin|Intravenous therapy given every 8 hours for up to 14 doses per week.
16153359|NCT01754376|Drug|Vemurafenib|Tablets given twice daily.
16153360|NCT01754363|Device|Attune Primary Total Knee Replacement|Patients will undergo a primary total knee replacement using one of the four configurations of the Attune knee (CR FB, CR RP, PS FB, PS RP).
16153361|NCT01754350|Dietary Supplement|calorie-restricted ketogenic diet and transient fasting|"On day 1-3 and day 7-9, restriction of carbohydrates to < 60 g and of calories to 21-23 kcal/kg per day, on day 4-6 fasting. On day 1-3 and 7-9, restriction of carbohydrates can be supported by the use of drinks provided by Tavarlin."
16153362|NCT01754350|Dietary Supplement|standard nutrition|nutrition as recommended by the german society for nutrition, 30 kcal/kg per day
16153398|NCT01753986|Behavioral|Brief Alcohol Intervention plus Standard Batterer Intervention|Brief Alcohol Intervention plus 40 hours or Standard Batterer Intervention
16153399|NCT01753986|Behavioral|General Health Improvement Intervention plus Standard Batterer Intervention|General Health Improvement Intervention plus 40 hours of Standard Batterer Intervention
16153363|NCT01754337|Other|Closed-loop system|Patients will be admitted at the research clinical facility at 7:00. At 8:00, a mixed meal will be served. At 9:00, patients will be asked to perform two 30-min standardized activities. At 12:00, a mixed meal will be served. At 13:00, patients will be asked to perform two 30-min activities. At 17:00, a mixed meal will be served. At 19:30, patients will perform 60 minutes of aerobic treadmill exercise at an intensity of 60% VO2max. A bedtime snack of 20g carbohydrate will be given at 21:00. Patients will be discharged at 8:00 the next morning
16153364|NCT01754324|Drug|Methadone|The starting dose of the protocol is 0.05mg/kg by mouth given every 6 hours and gradually decreased in a stepwise, standardized fashion.
16153365|NCT01754298|Procedure|Retro-articular drilling|"Drilling must be performed under AP and lateral fluoroscopic guidance, with no additional drilling in 'trans-articular', or intra-articular trans-condylar fashion.
~Use a 0.045 K-wire for drilling.
~Minimum of 8 wire passes per square centimeter with no maximum number of wire passes."
16153366|NCT01754298|Procedure|Trans-articular drilling|"Drilling must be performed, under arthroscopic visualization, directly through the articular cartilage, with no additional drilling in 'retro-articular', 'extra-articular', or trans-condylar (through the intercondylar notch)
~Use a 0.045 K-wire for drilling
~A minimum 4 wire passes per square centimeter, with a maximum of 5 wire passes per square centimeter"
16153367|NCT01754285|Drug|LF-PB and Placebo|
16153368|NCT01754285|Drug|Placebo|
16153369|NCT01754285|Drug|LF-PB|
16153370|NCT01754259|Drug|Ranolazine|Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor. Each patient will receive both ranolazine and placebo for 4 weeks, but both the investigator and subject are blinded to the order.
16153371|NCT01754259|Drug|Placebo|Subject will receive labeled bottles containing tablets with ranolazine 500 mg or a matching placebo provided by the sponsor. Each patient will receive both ranolazine and placebo for 4 weeks, but both the investigator and subject are blinded to the order.
16153372|NCT01754246|Device|755nm Alexandrite Laser|755nm Alexandrite laser for treatment of epidermal pigmented lesions and skin toning in Asian skin types
16153373|NCT01754233|Device|755nm Alexandrite Laser|755nm Alexandrite Laser for epidermal and dermal pigmented lesions
16153374|NCT01754220|Drug|Montelukast|Montelukast is a leukotriene receptor antagonist
16153375|NCT01754207|Device|755nm Alexandrite Laser|755nm Alexandrite Laser
16153376|NCT01754207|Device|755nm Alexandrite Laser with CAP Array|755nm Alexandrite Laser with CAP Array
16153377|NCT01754194|Procedure|Gastric Sleeve Resection|Laparoscopic Gastric Sleeve Resection
16153378|NCT01754194|Procedure|Roux-en-Y Gastric Bypass|Laparoscopic Roux-en-Y Gastric Bypass
16153379|NCT01754181|Drug|Insulin|the intervention is applied only at the dose of insulin
16153380|NCT01754155|Radiation|RSA images|All subjects will have the Vitamin E polyethylene and RSA beads placed during surgery. Subjects will then have standard x-ray images and RSA images taken at specific time points up until 2 years post-operatively.
16153381|NCT01754116|Drug|GSK1265744 30 mg oral|GSK1265744B 30 mg Tablet taken orally, once a day in the morning with or without a meal
16153382|NCT01754116|Drug|Midazolam 3 mg oral + GSK1265744 30mg oral|Midazolam Syrup 3mg each mL Oral/single dose administer by oral syringe on Day -29 and Day -14
16153383|NCT01754116|Drug|GSK1265744 400 mg (200 nm)|A single dose of GSK1265744 400 mg Intra Muscular (IM) injection (Nanomilled 200 nm)
16153384|NCT01754116|Drug|GSK1265744 400 mg (1 micro m)|A single dose of GSK1265744 400 mg IM injection (Nanomilled 1 micrometer)
16153385|NCT01754116|Drug|GSK1265744 400 mg (5 micro m)|A single dose of GSK1265744 400 mg IM injection (Dry milling and homogenization 5 micrometer)
16153386|NCT01754103|Other|Tactile Training|Tactile Training to induce neuroplasticity in the visual pathway, measured with functional connectivity MRI
16153387|NCT01754090|Behavioral|Online screening and feedback|An online single session screening procedure including individualized normative feedback.
16153388|NCT01754090|Behavioral|Online booklet.|An online booklet that covers general information about alcohol, its effect on the brain and the body, potential risks and harms of drinking, and an account of the threshold values of sensible drinking
16153389|NCT01754090|Behavioral|Online multi session follow-up|"An online multi session follow-up program (i.e., Balance). The central concept of Balance is to support continued self-regulation throughout the behavior change process. There are four key aspects of the program, the first is focus on goal setting and tracking of alcohol consumption on a day-to-day basis. The second on relapse prevention - for example, when clients report drinking more than their target, they receive individualized content aimed at preventing a full blown relapse. The third is emotion regulation, where content and assignments from positive psychology and from cognitive behavioral therapy are used. Finally, intervention covers alcohol education (i.e. the same topics as in the booklet provided to the control group)."
16153390|NCT01754077|Behavioral|LENA Linguistic Feedback Reports|LENA feedback reports show hourly/daily estimates for AWC/CTC and TV/electronic media. The feedback reports will include data obtained from LENA home audio recordings that the families complete. Feedback reports are only given to parents for 8 weekly recordings. The parent does not receive a feedback report for the baseline recordings or the follow-up recordings.
16153391|NCT01754077|Behavioral|Home Visiting Educational Session|A research assistant visited the homes of the participants to discuss strategies, skills, and barriers related to enriching children's language environments. The visits included a multi-media educational module, video modeling exercise, goal setting, and linguistic feedback report review. There were 8 weekly home visits in the intervention program.
16153392|NCT01754077|Behavioral|Childhood Nutrition Education|The childhood nutrition education intervention is a brief home-visiting intervention during which parents receive information on nutrition from a research assistant. The intervention mirrored the experimental group's educational intervention and decreased the likelihood of differences between groups being the result of attentional effects. This intervention is received by the control group.
16153393|NCT01754064|Device|Cardiac Rhythm Management device|
16153394|NCT01754051|Device|PC 400 coils|
16153395|NCT01754012|Dietary Supplement|Dietary Intervention|nutrient-rich diet and 10micrograms per day of Vitamin D (cholecalciferol) supplement from MCOHealth
16153396|NCT01753999|Device|Standard CPAP|Use of the REMstar Auto A-Flex in standard CPAP therapy mode
16153397|NCT01753999|Device|CPAP - Flex|Use of Philips Respironics REMstar Auto A-Flex in C-Flex mode
16153401|NCT01753921|Other|this is not an intervention study|Subjects will wear the headband/helmet-like device for approximately 10 minutes on four different occasions: t=0, t=1week, t=1month, t=3months. Of note, part of the device also involves electrodes that are worn to obtain an electrocardiogram or EKG.
16153402|NCT01753921|Other|this is not an intervention study|Subjects will be asked to participate in both computerized and non-computerized tests to assess subjects' cognitive (learning, language and memory) abilities, developmental level, and behavior. Tests will take place at t=0, t=1week, t=1month, t=3months.
16153403|NCT01753921|Device|MRI|MRI study of the brain will be performed at t=3months.
16153404|NCT01753908|Drug|Broccoli Sprout Extract|Given PO
16153405|NCT01753908|Other|Laboratory Biomarker Analysis|Correlative studies
16153406|NCT01753908|Other|Pharmacological Study|Urinary ITCs and metabolites measured
16153407|NCT01753908|Other|Placebo|Given PO
16153408|NCT01753882|Drug|Lexapro|Agent + training vs Placebo + training
16153409|NCT01753882|Drug|Placebo|Agent + training vs Placebo + training
16153410|NCT01753869|Procedure|Airways clearance and Hypertonic saline inhalation|
16153411|NCT01753856|Drug|Teriparatide|Administered SC
16153412|NCT01753856|Drug|Denosumab|Administered SC
16153413|NCT01753856|Drug|Demeclocycline|Administered orally
16153414|NCT01753856|Drug|Tetracycline|Administered orally
16153415|NCT01753856|Drug|Calcium Supplement|Administered orally
16153416|NCT01753856|Drug|Vitamin D|Administered orally
16153417|NCT01753843|Procedure|early cord clamping|early ( <20 seconds)
16153418|NCT01753843|Procedure|Brief Delay in cord clamping|delay in cord clamping 30 to 60 seconds
16153419|NCT01753830|Device|Durolane|4.5 mL
16153420|NCT01753830|Device|PBS|4.5 mL
16153421|NCT01753804|Other|Observational study|There is no medication or device tested in this study. This is an obversational study on the progression of the disease.
16153422|NCT01753791|Drug|80 mg PF-06473871|80 mg of PF-06473871 or placebo
16153423|NCT01753791|Drug|160 mg PF-06473871|160 mg of PF-06473871 or placebo
16153424|NCT01753791|Drug|320 mg PF-06473871|320 mg of PF-06473871 or placebo
16153425|NCT01753791|Drug|480 mg PF-06473871|480 mg of PF-06473871 or placebo
16153426|NCT01753778|Device|Cryo-Touch III Device|Treatment with Cryo-Touch III
16153427|NCT01753765|Device|Device: Cryo-Touch III Study treatment at Day 0.|Device: Cryo-Touch III Study treatment at Day 0.
16153428|NCT01753752|Drug|Chitosan- N- Acetylcysteine eye drops|
16153429|NCT01753752|Drug|Placebo|
16153430|NCT01753739|Drug|Bepotastine besilate|Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
16153431|NCT01753739|Drug|Placebo|Nasal spray administered in the morning and at night approximately 12 hours apart daily for 14 days
16153432|NCT01753726|Other|Diaphragm stretching.|A manual technique of diaphragm stretching during 7 minutes. The participants were situated in a seated position.
16153433|NCT01753726|Other|Placebo.|Disconnected ultrasound was used for the 7 min as sham treatment
16153434|NCT01753713|Drug|dovitinib|Given PO
16153435|NCT01753713|Other|laboratory biomarker analysis|Correlative studies
16153436|NCT01753700|Dietary Supplement|UHT treated milk|
16153437|NCT01753687|Other|Ocular scattering of the tear film|
16153438|NCT01753687|Other|Optical Coherence Tomography (OCT)|Tear film thickness as measured with OCT
16153439|NCT01753687|Other|Measurement of tear film osmolarity|
16153440|NCT01753674|Dietary Supplement|TA-65|TA-65 will be provided to volunteers, 2 pills per day of 8 mg each
16153441|NCT01753674|Dietary Supplement|Placebo|Placebo supplement will be provided to volunteers, 2 pills per day of 8 mg each
16153442|NCT01753661|Behavioral|Linguistic Feedback Report|Throughout the study, parents will complete 16 total LENA recordings. The feedback report will include information on the parent's previous LENA recording(s), including the Adult Word Count (AWC), Conversational Turns (CTC), and TV Time (TVT). Parents in the treatment group will receive feedback reports for the baseline and 10 weekly recordings. Feedback reports will not be offered for the follow-up recordings
16153443|NCT01753661|Behavioral|Multimedia Education Sessions|Treatment group parents will receive 10 weekly home visit sessions (e.g. the ASPIRE Program) with an interventionist during which time they will review multimedia education modules. The sessions include feedback report review, module discussion, video modeling, and goal setting activities. The education modules provide parents with information on supporting the development of listening and spoken language for children with hearing loss.
16153444|NCT01753661|Behavioral|EI-As-Usual|The EI-as-usual condition will parallel the treatment condition. Families in the EI-as-usual condition will continue to receive their usual therapy. They will not participate in Project ASPIRE home visits or receive feedback on their recordings. Families in this group will complete the same assessments as the families in the treatment group.
16153445|NCT01753648|Device|Dynamic Vessel Analyzer|Retinal vessel diameter, total retinal blood flow (together with FD-OCT), retinal oxygen saturation
16153446|NCT01753648|Other|FDOCT|total retinal blood flow (together with DVA), retinal blood velocities
16153447|NCT01753648|Other|Ocular perfusion pressure|Measurement of intraocular pressure and mean arterial blood pressure for determination of ocular perfusion pressure
16153448|NCT01753635|Device|supraglottic airway placement and use|
16153449|NCT01753622|Behavioral|Exercise group|"Supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise, 10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training.
~Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60 of maximal heart rate. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate."
16153450|NCT01753609|Device|Tulip capsule|swallowing Tulip capsule for up to 29 days
16153451|NCT01753596|Device|GENTEAL HA® Eye Drops (NOVARTIS, Switzerland)|
16153452|NCT01753596|Other|Physiological Sodium Chloride solution (0,9%)|Placebo
16153453|NCT01753583|Device|Optical Coherence Tomography (OCT)|High-resolution OCT imaging of the cornea
16153508|NCT01753102|Drug|Estradiol|one tablet will be inserted daily for 14 days
16153454|NCT01753583|Other|Slit lamp biomicroscopy|Slit lamp biomicroscopy with fluorescein staining and slit lamp photograph
16153455|NCT01753570|Drug|MP-424|MP-424: 750mg every 8 hours (q8h) for 12 weeks
16153456|NCT01753570|Drug|RBV(24 weeks)|RBV: 600 - 1000mg/day based on body weight for 24 weeks
16153457|NCT01753570|Drug|IFN beta(24 weeks)|IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3 days/week for 24 weeks
16153458|NCT01753570|Drug|RBV(48 weeks)|RBV: 600 - 1000mg/day based on body weight for 48 weeks
16153459|NCT01753570|Drug|IFN beta(48 weeks)|IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3 days/week for 48 weeks
16153460|NCT01753557|Drug|MP-424|MP-424: 750mg every 8 hours (q8h) for 12 weeks
16153461|NCT01753557|Drug|RBV|RBV: 600 - 1000 mg/day based on body weight for 24 weeks
16153462|NCT01753557|Drug|PEG-IFN alfa-2a|PEG-IFN alfa-2a: 180mcg/week for 24 weeks
16153463|NCT01753531|Device|Flu Symptoms|
16153464|NCT01753518|Device|Subcuticular suture|subcuticular Monocryl suture closure
16153465|NCT01753518|Device|Subcuticular staple|subcuticular staple wound closure with INSORB 20 device
16153466|NCT01753505|Other|64-slice Multidetector coronary CT angiography|
16153467|NCT01753492|Device|Ologen|
16153468|NCT01753479|Other|Spectroscopy device|Spectrum data are collected using spectroscopy device via an instrumental channel of endoscope. Then spectrum data is analyzed. Numerical features (spectral slope and width of spectrum) are used for statistical analysis.
16153469|NCT01753466|Dietary Supplement|Hydration|
16153470|NCT01753453|Drug|Plerixafor|240mcg/kg, solution, subcutaneous injection
16153471|NCT01753453|Drug|Granulocyte-colony stimulating factor (G-CSF)|10 mcg/kg, solution, subcutaneous injection
16153472|NCT01753440|Procedure|Intramyocardial implantation of of a novel mesenchymal precursor cell type (iMP).|Intramyocardial implantation of a novel mesenchymal precursor cell type (iMP).
16153473|NCT01753414|Radiation|Stereotactic Body Radiation Therapy (SBRT)|SBRT given every other day 11 Gy in 5 fractions to a total dose of 55 Gy in 10-15 days with an inter-fraction interval of 2-3 days
16153474|NCT01753414|Procedure|Surgery|Complete resection, i.e., removal of the primary tumor with at least a 2 cm margin together with nodal dissection/sampling
16153475|NCT01753401|Drug|Acthar|Acthar is given by subcutaneous (SC) injection (shot under the skin), at a dose of 40 units daily or 80 units every other day
16153476|NCT01753401|Drug|Placebo|Placebo contains the same inactive ingredients as Acthar, and is given by SC injection
16153477|NCT01753401|Drug|Steroid Drug|The patient's steroid regimen 7.5 to 30 mg/day of prednisone or equivalent, chronic/stable within the 4 weeks prior to screening.
16153478|NCT01753388|Device|Liberty Stent|
16153479|NCT01753375|Dietary Supplement|Vitamin D3|Vitamin D3 given as 50000 IU orally on weekly basis
16153480|NCT01753375|Dietary Supplement|Placebo|Placebo to be given orally on weekly basis
16153481|NCT01753362|Drug|liraglutide|
16153482|NCT01753362|Drug|placebo|
16153483|NCT01753349|Biological|Botulinum toxin type A|Investigators were free to prescribe any BoNT A preparation, including Dysport, Botox and Xeomin.
16153484|NCT01753336|Biological|Botulinum toxin type A|Dysport® (intramuscular injection), Up to 500 units (U)/vial using 2mL dilution, 3 treatment cycles
16153485|NCT01753323|Drug|KAF156|KAF156 was supplied as tablets for oral use.
16153486|NCT01753310|Biological|Botulinum toxin type A|Intramuscular injection, between 250 and 500 units (U)/vial using 2mL dilution, 1 cycle only
16153487|NCT01753310|Drug|Placebo|Up to 2mL
16153488|NCT01753297|Drug|Triptorelin 11.25 mg|Triptorelin, one injection every 3 months. A total of 3 injections (at baseline, 3 and 6 months)
16153489|NCT01753271|Other|thoracic mobilization & shoulder mobilization & exercise|
16153490|NCT01753271|Other|shoulder mobilization & exercise|
16153491|NCT01753232|Device|DALI-adsorber|Recording of treatment data. No extra interventional treatment
16153492|NCT01753232|Device|MONET-Lipoprotein filter|Only treatment data recording. No extra interventional treatment
16153493|NCT01753219|Procedure|Onstep|
16153494|NCT01753219|Procedure|Lichtenstein|
16153495|NCT01753193|Biological|Anifrolumab|Intravenous infusion of anifrolumab will be administered as 1000 mg Q4W from Day 1 (Week 0) until 12-Feb-2015 (approval of protocol amendment 4); and thereafter 300 mg Q4W up to 3 years or until the sponsor discontinued development of anifrolumab, whichever came first.
16153496|NCT01753180|Biological|collagenase|Local intra-coronary administration of MZ-004 at or into the CTO
16153497|NCT01753180|Drug|saline|Local intra-coronary administration of saline at or into the CTO
16153498|NCT01753167|Drug|MCMV3068A|Four doses of MCMV3068A (10 mg/kg) administered by intravenous infusion at the time of transplantation (Day 1), and at Days 8, 29, and 57.
16153499|NCT01753167|Drug|MCMV5322A|Four doses of MCMV5322A (10 mg/kg) administered by intravenous infusion at the time of transplantation (Day 1), and at Days 8, 29, and 57.
16153500|NCT01753167|Drug|Placebo|Four doses of placebo matched to MCMV5322A/MCMV3068A administered by intravenous infusion at the time of transplantation (Day 1), and at Days 8, 29, and 57.
16153501|NCT01753154|Drug|Solution B (balance PD solution)|balance 1.5% glucose, solution for peritoneal dialysis; balance 2.3% glucose, solution for peritoneal dialysis; balance 4.25% glucose, solution for peritoneal dialysis, each with 1.25 mmol/l or 1.75 mmol/l calcium
16153502|NCT01753154|Drug|Solution A (conventional PD solution)|Solutions for peritoneal dialysis: CAPD 2 (1.5% glucose, 1.75mmmol/l calcium), CAPD 3 (4.25 % glucose, 1.75mmmol/l calcium), CAPD 4 (2.3% glucose, 1.75mmmol/l calcium), CAPD 17 (1.5% glucose, 1.25mmmol/l calcium), CAPD 18 (4.25% glucose, 1.25mmmol/l calcium) and CAPD 19 (2.3% glucose, 1.25mmmol/l calcium)
16153503|NCT01753141|Behavioral|Cognitive Behavioral Therapy for smoking cessation|
16153504|NCT01753141|Behavioral|Cognitive Behavioral Therapy for smoking cessation and anxiety sensitivity reduction.|Includes anxiety sensitivity (AS) psychoeducation and interoceptive exposure exercises in addition to regular smoking cognitive behavioral therapy.
16153505|NCT01753128|Drug|imipramine|
16153506|NCT01753115|Biological|BioThrax|route of administration/schedule- 0.5 mL subcutaneous (SC) injection / 0-2-4 week schedule
16153507|NCT01753115|Drug|Ciprofloxacin|500 mg twice a day (Days 1-6, 19-21, 33-35, 40-48).
16153509|NCT01753089|Biological|WDVAX|
16153510|NCT01753076|Drug|Ozanezumab|Ozanezumab injection solution
16153511|NCT01753076|Drug|Placebo|Normal saline (0.9% sodium chloride) infusion
16153512|NCT01753063|Behavioral|Patient Expectations|Baseline Expectations survey (parent/guardian and adolescents 12 and older)
16153513|NCT01753063|Behavioral|Patient Expectations|3 month follow up survey (parent/guardian and adolescents 12 and older)
16153514|NCT01753050|Device|Stroke volume monitoring|Pulse contour stroke volume monitoring
16153515|NCT01753037|Dietary Supplement|Dehydroepiandrosterone (DHEA)|DHEA 130 mg administered orally for 5 days.
16153516|NCT01753037|Other|Placebo|Placebo contained in a capsule that is identical in appearance to the one used to package DHEA for 5 days.
16153517|NCT01753024|Dietary Supplement|Enteral nutrition (EN)|All patients enrolled in this study must carry out nutritional support by enteral nutrition
16153518|NCT01752998|Behavioral|Treating Opioid Patients' Pain and Sadness (TOPPS)|
16153519|NCT01752998|Behavioral|Health Education|
16153520|NCT01752985|Drug|BMS-813160|
16153521|NCT01752985|Drug|Placebo matching with BMS-813160|
16153522|NCT01752972|Dietary Supplement|Spirulina|10 g/day orally for 12 weeks
16153523|NCT01752959|Drug|Remifentanil|0.1-0.3 micg/kg/min Remifentanil iv infusion
16153524|NCT01752959|Drug|Esmolol|500 μcg/kg/dk esmolol iv lading dose after 50-500 μcg/kg/dk esmolol iv infusion
16153525|NCT01752933|Drug|SGI-110|SGI-110 will be administered by subcutaneously (SC) on Days 1 - 5 every 28 days until disease progression or unacceptable toxicity
16153527|NCT01752907|Other|General Education DVD|A general chemotherapy side effects education DVD
16153528|NCT01752907|Other|Bone Pain Education DVD|
16153529|NCT01752894|Device|Angio-guided PCI with EES or BES|Angio-guided intervention
16153530|NCT01752894|Device|OCT-guided PCI with EES or BES|OCT-guided intervention
16153531|NCT01752894|Device|PCI with BES under angio-guide or OCT guide|biolimus A9-eluting stent.
16153532|NCT01752894|Device|PCI with EES under angio-guide or OCT guide|everolimus eluting stent.
16153533|NCT01752894|Drug|Keep DAPT|maintain DAPT for 12 months according to level of uncovered strut (>6%) at 3months OCT follow up after stent implantation.
16153534|NCT01752894|Drug|Discontinue DAPT|discontinue DAPT according to level of uncovered strut (≤6%) at 3months OCT follow up after stent implantation.
16153535|NCT01752881|Biological|Influenza vaccine (split virion, inactivated)|"AdimFlu-S, Inactivated Influenza Vaccine Trivalent Types A and B (Split) Formulation 2012-2013
~Dosage: 0.5mL/per syringe
~Administration route: Intramuscular Injection, once"
16153536|NCT01752881|Biological|AdimFlu-S|
16153537|NCT01752868|Dietary Supplement|Supplement|Participants in this group will take the following nutritional supplements on a daily basis: curcumin, fish oil, resveratrol, sesamin, Acetyl-L-carnitine, lipoic acid, green and black teas, quercetin, pomegranate, cinnamon bark.
16153538|NCT01752855|Biological|New formulation adalimumab|New formulation adalimumab 40 mg every other week
16153539|NCT01752842|Drug|Fenofibrate|
16153540|NCT01752842|Drug|Placebo for fenofibrate|
16153541|NCT01752816|Behavioral|exercise training|
16153542|NCT01752803|Dietary Supplement|Probiotic|mix probiotic
16153543|NCT01752803|Dietary Supplement|Placebo|placebo
16153544|NCT01752790|Drug|Top-down|Patients randomized to top-down arm will receive an induction regimen of three consecutive i.v. infusions of infliximab (Remicade, 5 mg/kg) at weeks 0, 2, and 6 plus AZA (2 mg/Kg per os/day). Patients who will not respond to the induction regimen at week 8 will receive no further treatment with infliximab. Disease recurrences will be treated with infliximab (reduction of the interval between two doses). At 12 months pazients will discontinue azathioprine and continue infliximab (5mg/kg every 8 weeks). During the trial, other drugs will be not allowed, including immunosuppressive agents, other biological agents or steroids.
16153545|NCT01752790|Drug|Step-up|Patients randomized on Step-up arm will receive methylprednisolone (1 mg/Kg/day per os. for 2 weeks then tapering of 5 mg/week then stop) plus azathioprine (2 mg/Kg/die per os/day).Disease recurrences under azathioprine will be treated with steroid courses (methylprednisolone 1-2 mg/Kg/day per os. for 2 weeks then tapering of 5 mg/week then stop). During the trial, other drugs will be not allowed, including immunosuppressive agents, other biological agents or steroids.
16153546|NCT01752777|Behavioral|Infectiousness Risk Reduction|Behavioral counseling conducted in one office session followed by 4 cell-phone-based sessions. Counseling is based on models of behavioral self-management and cognitive decision making with the primary aim to increase antiretroviral adherence, engagement in HIV care, and reduction of sexual risk behaviors for HIV transmission.
16153547|NCT01752777|Behavioral|General Health Improvement|Educational counseling to help link participants to social serves and health related strategies.
16153548|NCT01752764|Other|Test product: Salad with a high dosage fat|
16153549|NCT01752764|Other|Control product: Salad with low dosage fat|
16153550|NCT01752725|Device|BiCision®|
16153551|NCT01752725|Device|Ultracision® Har-monic Scalpel(Ethicon)|
16153552|NCT01752712|Drug|CBSST + Oxytocin|The oxytocin dose of 80 IU/day, will be administered in two divided doses: 40 IU in the morning and 40 IU in the evening. Oxytocin will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group.
16153553|NCT01752712|Drug|CBSST + Placebo|Matching placebo spray will be administered intranasally (10 puffs of the spray, 5 in each nostril at each administration). CBSST groups will occur for an hour twice/week. Nasal spray will be administered an hour prior to the CBSST group.
16153554|NCT01752699|Drug|Methadone|patients with post-herpetic neuralgia take methadone or placebo to treat pain symptoms.
16153555|NCT01752699|Drug|Placebo|patients with post-herpetic neuralgia take placebo to treat the pain symptoms.
16153556|NCT01752686|Drug|carboplatin|carboplatin as adjuvant chemotherapy
16153557|NCT01752673|Other|Visualized pulmonary embolism computer task model|This group of participants was presented and trained to use a visual representation of diagnostic pathway for pulmonary embolism. The design of this visual representation is based on Bayes theorem and cognition enhancing visual design principles.
16153558|NCT01752673|Other|Didactic review lecture|This group of participants was presented with a didactic lecture covering the diagnostic approach of pulmonary embolism.
16153559|NCT01752660|Behavioral|Endurance training|Standard care during a 4 week inpatient stay at a Danish multiple sclerosis rehabilitation center added 3 weekly sessions of endurance training for the upper extremity.
16153560|NCT01752660|Behavioral|Standard care|Standard care during a 4 week inpatient stay at a Danish multiple sclerosis rehabilitation center.
16153561|NCT01752647|Procedure|Low dose computed tomography|Low dose computed tomography scan
16153562|NCT01752634|Drug|Secukinumab (AIN457)|Secukinumab (AIN457)
16153563|NCT01752634|Drug|Placebo|Placebo PFS for s.c. administration.
16153564|NCT01752608|Behavioral|eCBT Mood|A handheld, computerized, electronic cognitive behavioral therapy (CBT) application
16153565|NCT01752595|Behavioral|Preference Based Rhythmic Auditory Stimulation Music|"Patients that have been randomized into arms 2 and 3 will be blinded to the intervention they are receiving (i.e. preference-based playlist vs. preference-based playlist that has been edited to include Rhythmic Auditory Stimulation (RAS). RAS drives synchronous neural oscillation (entrainment) and functions in two ways: (1) facilitates pace and heart-rate synchrony and (2) facilitates brain state dominance (getting into the zone). RAS will be accomplished through: (1) sequencing of subject self-selected music based on tempo, (2) accentuation of the rhythmic driving pulse with added percussive-type sounds, (3) addition of binaurally detuned pitches to follow bass lines at brain-state target frequencies (e.g., 8 Hz alpha, or 16 Hz beta), and (4) the addition of binaurally detuned background sounds (e.g., low frequency hum) at target Hz frequencies. RAS is implemented as inherent and natural to the music and may remain imperceptible to most."
16153566|NCT01752595|Other|Preference Based Music Intervention|
16153567|NCT01752582|Device|BuMA stent|About 35 patients will undergoing implantation of BuMA stent and receive 6 months dual antiplatelet therapy.
16153568|NCT01752582|Device|EXCEL stent|About 35 patients will undergoing implantation of EXCEL stent and receive 6 months dual antiplatelet therapy.
16153569|NCT01752569|Drug|Selumetinib|"The treatment schedule requires selumetinib to be taken either once daily at the same time each day or twice daily approximately 12 hours apart. Selumetinib should be taken with water at least 2 hours after a meal and 1 hour before the next meal. Selumetinib capsules will be administered in a continuous 21 day cycle (6 cycles), unless disease progression occurs.
~For phase I there were 4 potential dosing levels:
~Level -1 - 50mg once daily (od) (50mg daily total)
~Level 1 (starting dose level for phase I) - 50mg bi-daily (bd) (100mg daily total)
~Level 2 - 75mg bd (150mg daily total)
~Level 3 - 100mg bd (200mg daily total)
~Phase I has been completed and identified 75mg bd as the recommended phase II dose.
~Phase II has begun and is utilising a dose of 75mg bd of selumetinib."
16153570|NCT01752556|Procedure|diagnosis and therapeutic decision|A conventional polysomnography will be done to perform the diagnosis and therapeutic decision(CPAP or not). Treated and untreated will be followed 6 moths
16153571|NCT01752556|Procedure|diagnosis and therapeutic decision|A home respiratory polygraphy will be done to perform the diagnosis and therapeutic decision(CPAP or not). Treated and untreated will be followed 6 months
16153572|NCT01752543|Drug|Conivaptan|Conivaptan treatment: 20 mg bolus followed by infusion of 2 mg/hour
16153573|NCT01752543|Drug|Placebo (Dextrose)|Placebo treatment: 20 mg bolus followed by infusion of 2 mg/hour
16153574|NCT01752530|Other|Computer program C8|Experimental: Computer program C8 + treatment as usual: Playing a special computer program C8 40 min a day for 6 days a week for 8 weeks.
16153575|NCT01752530|Other|Treatment as usual|Treatment as usual at the clinic
16153576|NCT01752517|Drug|NI group|vinorelbine 25mg/m2 d1,d8; ifosfamide 1.25g/m2 d1-d3; Mesna 400mg iv 0,4,8 hours after ifosfamide administration for 3 days
16153577|NCT01752504|Behavioral|Community Mobilization|The proposed study seeks to continue C2P, a community mobilization intervention, which entails developing coalitions to plan for and bring about structural changes for purposes of reducing HIV incidence and prevalence among youth in targeted communities at five ATN sites. The C2P community mobilization model entails: determining a geographic area and population of focus for the coalitions to prioritize their planning and action; developing coalitions that have a shared vision and mission; developing a strategic plan focused on structural changes to reduce risks associated with HIV; documenting processes; providing feedback as technical assistance to the coalitions; hosting regular working group meetings; and on-going capacity building.
16153578|NCT01752491|Drug|Ascorbate|Intravenous infusion of high-dose ascorbate
16153579|NCT01752491|Drug|Temozolomide|Oral chemotherapeutic
16153580|NCT01752491|Radiation|Radiation therapy|External beam radiation therapy
16153581|NCT01752465|Behavioral|Health Coaching|Health Coaching sessions are 2 hours long. Participants individually receive a physical assessment, and recent blood work and medications are reviewed. When everyone has been assessed, the group reconvenes to watch a video about the importance of making healthy lifestyle choices, participates in a 10 min. fitness activity, and receives training on making SMART goals (SMART stands for specific, measurable, achievable, realistic, and timely). Each participant individually creates a SMART goal for him/herself, and this goal is reviewed as a group. Each participant rates the importance of this goal, and rates their level of confidence in succeeding. Progress is tracked in subsequent sessions, and metabolic health is continually monitored through routine blood work.
16153582|NCT01752465|Behavioral|Standard care|Standard clinical care will continue for all participants in the study, regardless of the study arm. This includes routine clinical visits to the attending psychiatrist, and receiving pharmacotherapy, standard patient education, and psychosocial training.
16153583|NCT01752439|Device|Anodal transcranial direct current stimulation|
16153584|NCT01752439|Device|Sham transcranial direct current stimulation|
16153585|NCT01752426|Other|Heavy Water (2H2O)|50 ml 70% 2H2O 3 times a day for the first 5 days followed by 60 ml daily for a total of 4 weeks. After the 5-day loading period, a 60 ml maintenance dose of 2H2O will be drunk at bedtime. At end of the 4th week, subjects stop drinking 2H2O (washout phase) and be followed from 6-12 weeks until beginning treatment with PCI-32765.
16153586|NCT01752426|Drug|PCI-32765|420 mg orally once daily.
16153587|NCT01752413|Dietary Supplement|Ferrous gluconate 325mg|Participants with low ferritin (<30 micrograms/L (males) or <20 micrograms/L (females)) will be asked to take two tablets of Ferrous Gluconate 325 mg (36 mg elemental iron) per day.
16153588|NCT01752413|Behavioral|Nutrition counseling|All blood donors receive current dietary counseling recommending iron rich foods
16153589|NCT01752400|Drug|AUY922|
16153590|NCT01752361|Device|Motilis-3D transit|
16153591|NCT01752348|Other|Endotoxin, US standard reference E.coli|
16153592|NCT01752335|Other|Braquial ecography|At the moment of the ecography, the clinician evaluates the endothelial responses via applying braquial ischemia and administering sublingual nitroglicerin spray to evaluate vasodilation.
16153593|NCT01752322|Drug|Lidocaine 5% medicated plaster|
16153594|NCT01752322|Drug|Placebo plaster|
16153595|NCT01752283|Procedure|video-assisted thyroidectomy|Experimental arm: video-assisted thyroidectomy under local anesthesia and hypnosis
16153596|NCT01752283|Procedure|Video-assisted thyroidectomy|video-assisted thyroidectomy under general anesthesia
16153597|NCT01752270|Drug|Diane-35 pretreatment|Diane-35 is applied from the third day of menstrual cycle for 21 days with a 7-day interval, for 3 consecutive cycles.
16153598|NCT01752270|Drug|Diane-35 pretreatment|
16153599|NCT01752257|Drug|EF5 Hypoxia|EF5 is a dye used to measure hypoxia
16153600|NCT01752244|Dietary Supplement|Placebo|corn oil Capsules 1 gram: were given to the placebo group once a day for 8 weeks
16153601|NCT01752244|Dietary Supplement|Alfacalcidol|Alfacalcidol
16153602|NCT01752218|Device|arcuate incision|
16153603|NCT01752205|Drug|Paclitaxel|45mg/m2/w,total 6 weeks
16153604|NCT01752205|Drug|Erlotinib|150mg/d,days 1-42,total 6 weeks
16153605|NCT01752205|Radiation|Radiation therapy|
16153606|NCT01752192|Device|Telerehabilitation programme|Telerehabilitation programme: Each patient in the intervention group will use a telehealth monitor. The patient will measure blood pressure, pulse and weight once or twice a week over a 3 months periode with the use of a blood pressure monitor and a weightscale connected to the monitor. The patients will also measure their steps daily by the use of a digital stepcounter. The patients will be able to see their data in a personal health record on a tablet where they can share informations with their GP, nurse and doctor at the hospital or healthcare center. The patient are also offered access to a portal called www.aktivehjerte.dk where they can find informations on rehabilitations topics in text, video and sound.
16153607|NCT01752179|Procedure|kinesio Tape : Width 5cm ,Length 35cm Y shape|"In the experimental group, Kinesio taping application of piriformis according to Kenzo Kase in 2003 is modified by using unloading technique (Macdolanld, 2004). Size and Shape of Tape is Width 5cm ,Length 35cm Y shape.
~Taping method include :
~stretches the piriformis muscle in side lying position ,the affected leg is upper most with hip in flexion, adduction and internal rotation.
~puts the base of tape over the contralateral of sacrum with no tension.
~attaches the superior tail on the buttock over the upper part of piriformis and ends at the greater trochanter of the femur.
~attaches the lower tail by lifting up the soft tissue and ends at the greater trochanter of the femur.
~This is an origin to insertion application."
16153608|NCT01752153|Drug|Desferrioxamine, Legalon® (Silymarin)|Desferrioxamine (Novartis Pharma AG, Switzerland) at the dose of 40 mg/Kg/day and Legalon® tablets (Madaus Pharma, Italy)
16153609|NCT01752153|Drug|Silymarin (Legalon)|
16153610|NCT01752140|Procedure|10-core prostate biopsy protocol|Local vascular bundle anesthesia with 2% lidocaine was performed using a 22G Chiba needle. Ultrasound guided prostate biopsy using a standard biopsy device to obtain 10 biopsy cores.
16153611|NCT01752140|Procedure|Vienna nomogram prostate biopsy protocol|Local vascular bundle anesthesia with 2% lidocaine was performed using a 22G Chiba needle. Ultrasound guided prostate biopsy using a standard biopsy device to obtain a number of cores as defined by the Vienna nomogram.
16153612|NCT01752127|Procedure|percutaneous coronary intervention using drug eluting stent|"1. Intracoronary stenting
~The procedure could be conducted via brachial, radial or femoral approaches.
~There are no restrictions regarding lesion's length or diameter. For long lesions, overlapping of several stents would be allowed but only allocated type of stents should be used.
~When several lesions are included in the study of a patient, each lesion may be allocated in different groups. Only if deployment of the allocated stent is not possible, crossing to other stent would be allowed.
~Direct stenting or bifurcation stenting is allowed.
~Predilation before stenting, IVUS examination, and administration of glycoprotein IIb/IIIa inhibitor would be determined by investigator."
16153613|NCT01752075|Drug|Revlimid|The prescribing physician should prescribe and monitor REVLIMID therapy according to the guidance and recommended schedules given in the approved Taiwan package insert (PI).
16153614|NCT01752049|Drug|Topical timolol maleate|"Topical timolol maleate 0.5% drops
~Applied twice daily for 12 weeks (84 days) or until disappearance of lesions
~Study drops will be applied to 4 cutaneous telangiectasias per patient (timolol drops for 3 telangiectasia per patient and placebo drops to 1 telangiectasia per patient)."
16153615|NCT01752049|Drug|placebo saline drops|Applied twice daily for 12 weeks (84 days) or until disappearance of lesions to one cutaneous telangiectasias per patient.
16153616|NCT01752036|Radiation|Post-operative, Stereotactic Body Radiation Therapy (SBRT)|All participants received SBRT at 600 cGy x 5 fractions
16153617|NCT01752023|Drug|Cisplatin + Gemcitabine with SUBATM-itraconazole|Experimental Arm
16153618|NCT01752023|Drug|Cisplatin + Gemcitabine|Active Comparator
16153619|NCT01752010|Other|Traditional Chinese Acupuncture|"Treatment will be performed by an experienced provider, and may include insertion of sterile 32-gage (0.25mm) acupuncture needles on any part of the body that can be needled while the subject is lying prone with their head in a face cradle. The needles are usually retained for 20-30 minutes along various meridian points identified by the practitioner as being blocked. Needles will be inserted to the depth typically recommended for the particular point of concern; generally 1 to 3cm. There are no constraints on the number of needles used. Acupuncture points are points of lower resistance and higher electrical conductance than the surrounding tissue. Placing the acupuncture needles into points identified as blocked is believed to help restore the flow of energy and stimulates the release of endorphins. The subject's level of pain is assessed on a 0-10 pain scale. Thirty minute acupuncture treatments will be given by the provider once a week for 6 weeks at the pain clinic."
16153640|NCT01751854|Drug|SSRI|SSRI alone or with training
16153641|NCT01751854|Drug|Placebo|Placebo alone or with training
16153620|NCT01752010|Device|Tennant™ Biomodulator Treatment|An FDA-approved Tennant™ 650 BioModulator will be used to deliver electrical stimulation. The device will be applied directly on top of the subject's area of pain for one minute; power is adjusted until the subject feels a slight tingle. Random variations of pulse amplitude are set from zero to a chosen comfort limit. A feedback mechanism is provided by the constant monitoring of skin impedance. The device is then pressed onto the site of pain and rotated counter-clockwise. After a minute, the device is placed on the opposite side of the pain site and the procedure repeated. The subject's level of pain is assessed on a 0-10 pain scale. At no time is the level of electrical stimulation allowed to cause sustained pain. The subject will receive a weekly 15 minute visit that includes a treatment provided by the pain provider. The provider will teach the subject how to use the machine by themselves and instruct the subject to use the machine twice a day on their own during the study.
16153621|NCT01752010|Device|Transcutaneous electrical nerve stimulation (TENS) Treatment|An FDA-approved Empi™ TENS unit will be used to deliver the transcutaneous electrical nerve stimulation. The low frequency TENS unit will be applied to the subject's area of pain by the use of four integrated self-adhering 5x5 cm electrodes. The electrodes will be positioned at a distance of 3 cm and centered over the area that is most painful. The device rapidly delivers therapeutic electrical currents at various frequencies off and on 150 times a second. The subject's level of pain is assessed on a 0-10 pain scale. At no time is the level of electrical stimulation allowed to cause sustained pain. The subject will receive a weekly 15 minute visit that includes a treatment provided by the pain provider. The provider will teach the subject how to use the machine by themselves and instruct the subject to use the machine twice a day on their own during the study.
16153622|NCT01751997|Drug|Transplants from 8/8-matched Unrelated donors|"Myeloablative conditioning
~Total body irradiation; 165 cGy, every 12 hours, 8 doses, days -7 to -4 (total 1320 cGy)
~Cyclophosphamide; 60 mg/kg/day, IV for 30 minutes, days -3 to -2 (total 120 mg/kg)
~Antithymocyte globulin (ATG); 1.25 mg/kg/day, IV for 6 hours, days -3 to -2, (total 2.5 mg/kg)
~Reduced-intensity conditioning; older patients (age > 55 years) and/or patients with comorbidities
~Fludarabine; 30 mg/m^2/day, IV for 1 hour, days -8 to -4 (total 150 mg/m^2)
~Busulfex; 3.2 mg/kg/day, IV for 3 hours, days -3 to -2 (total 6.4 mg/kg)
~Total body irradiation; 200 cGy, every 12 hours 2 doses, days -1 (total 400 cGy)
~ATG; 1.25 mg/kg/day, IV for 6 hours, days -3 to -2, (total 2.5 mg/kg)
~GVHD prophylaxis
~Tacrolimus; 0.03 mg/kg/day, IV for 24 hours from day -1 (0.12 mg/kg/day, PO, if tolerable)
~Methotrexate; 5 mg/m^2/day, IV push, days +1, +3, +6, +11"
16153623|NCT01751997|Drug|Transplants from family-mismatched/haploidentical donors|"Reduced-intensity conditioning
~Total body irradiation; 200 cGy, every 12 hours, 4 doses, days -9 to -8 (total 800 cGy)
~Fludarabine; 30 mg/m^2/day, IV for 1 hour, days -7 to -3 (total 150 mg/m^2)
~Busulfex; 3.2 mg/kg/day, IV for 3 hours, days -6 to -5 (total 6.4 mg/kg)
~ATG; 1.25 mg/kg/day, IV for 6 hours, days -4 to -1 (total 5.0 mg/kg)
~GVHD prophylaxis
~Tacrolimus; 0.03 mg/kg/day, IV for 24 hours from day -1 (0.12 mg/kg/day, PO, if tolerable)
~Methotrexate; 5 mg/m^2/day, IV push, days +1, +3, +6, +11"
16153624|NCT01751984|Drug|ETC-1002|Weeks 1-2, 60 mg/day; Weeks 3-4, 120 mg/day; Weeks 5-6, 180 mg/day; Weeks 7-8, 240 mg/day
16153625|NCT01751984|Drug|Placebo|Placebo once daily for 8 weeks
16153626|NCT01751971|Drug|Inspired oxygen (40%)|Supplemental oxygen at 40% inspired via venturi mask (15 L/min). Equivalent to 5 L/min via nasal cannula.
16153627|NCT01751971|Other|Sham|Medical air with 21% oxygen via venturi mask (15 L/min).
16153628|NCT01751958|Radiation|Epidural steroid injection|Epidural steroid injection
16153629|NCT01751945|Behavioral|EmONC package|"The EmONC package consists of:
~Maternal and neonatal health pack(clean delivery kit, emollient, chlorhexidine, sms messages) for safe motherhood and newborn wellbeing.
~Enhanced trainings of community-level health care providers to provide effective maternal and neonatal health services and referral of complicated cases to health facilities and creation of linkages amongst health care providers.
~Community mobilisation"
16153630|NCT01751932|Device|CGM Monitoring|All patients will be fitted with the two study CGM systems. Paradigm Veo will be configured to use the CGM part only if another pump is used.
16153631|NCT01751919|Drug|Imatinib mesylate tablet 400 mg, 1 Tablet|
16153632|NCT01751919|Drug|Glivec film-coated tablet 100 mg, 4 Tablets|
16153633|NCT01751906|Device|Absorb BVS|"Scaffold diameters: 2.5, 3.0 and 3.5 mm
~Scaffold lengths: 8, 12, 18, and 28 mm The 3.0 x 18 mm Absorb BVS will be used for the Lead-In. Both the 8 mm and 12 mm lengths will be available for the 2.5/3.0 mm diameter Absorb BVS. Only the 12 mm length will be available for the 3.5 mm diameter.
~The commercially approved CE marked device will be used in geographies where it is commercially available. The commercially approved CE marked 23mm Absorb BVS device will not be used in this study.
~Bioabsorbable drug eluting stent implantation for improving coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
16153634|NCT01751906|Device|XIENCE|"Commercially approved XIENCE Family Stent System, inclusive of XIENCE V, XIENCE PRIME, XIENCE Xpedition, XIENCE Alpine, XIENCE Pro (OUS only), and XIENCE ProX (OUS only).
~Stent diameters: 2.5, 2.75, 3.0, 3.25, 3.5 and 4.0 mm
~Stent lengths: 8, 12, 15, 18, 23, and 28 mm. The 3.25 mm is only available for XIENCE Xpedition
~For geographies where these devices are commercially available, the investigational sties may use only their locally approved devices
~To improve coronary luminal diameter in patients, including those with diabetes mellitus, with ischemic heart disease due to de novo native coronary artery lesions (length ≤ 24 mm) with a reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm."
16153635|NCT01751893|Drug|Henna|natural henna in the form of paste
16153636|NCT01751893|Drug|Placebo|placebo
16153637|NCT01751880|Behavioral|physical activity intervention|Exercise program is scheduled to be conducted in three phases. Phase I is in-hospital exercise program. This program will be conducted in hospital during 1 week after surgery. Phase II is home-exercise program that will be performed at home during 1 week after discharge. Phase III is main-exercise program that will be conducted the fitness center nearby hospital during 8 weeks after phase II program. Main-exercise program is focused on the functional recovery.
16153638|NCT01751867|Drug|Decitabine at 15 mg/m2|Decitabine will be given at a dose of 15 mg/m2 as a continuous intravenous infusion within a 3-hour intravenous infusion, repeated every 8 hours for 3 consecutive days.The total dose per day is 45 mg/m2; The total dose per course is 135 mg/m2. Cycles will be repeated every 6 weeks.
16153639|NCT01751867|Drug|Decitabine at 20 mg/m2|Decitabine will be given at a dose of 20 mg/m2 as 1-hour IV infusion once daily on Days 1 through 5, of a 4-week treatment cycle.
16153643|NCT01751815|Procedure|Acu-TENS|Patients randomized to the experimental group will receive Acu-TENS on acupoints relevant to the treatment of abdominal pain and distension, including Zusanli (stomach meridian ST-36), Hegu (large intestine meridian LI-4), Neiguan (pericardium meridian PC-6), Tianshu (stomach meridian ST-25), and Dachangshu (bladder meridian BL-25).
16153644|NCT01751815|Procedure|Placebo-TENS|Patients randomized to the control group will receive placebo-TENS at the same acupoints.
16153645|NCT01751802|Drug|Ecopipam|Antagonist of the dopamine D1 receptor
16153646|NCT01751802|Drug|Placebo|Placebo for Ecopipam
16153647|NCT01751789|Behavioral|Linkage|
16153648|NCT01751789|Other|Treatment as Usual|
16153649|NCT01751776|Drug|BI 655064 medium dose|Medium dose
16153650|NCT01751776|Drug|BI 655064 high dose|High dose
16153651|NCT01751776|Drug|BI 655064 high dose|High dose
16153652|NCT01751776|Drug|Placebo|Placebo
16153653|NCT01751776|Drug|BI 655064 low dose|Low dose
16153654|NCT01751776|Drug|Placebo|Placebo
16153655|NCT01751776|Drug|BI 655064 medium dose|Medium dose
16153656|NCT01751763|Drug|Sorafenib (Nexavar, BAY43-9006)|treatment (including dose, duration, modification) decided by the investigator.
16153657|NCT01751750|Other|Grape|16 oz. of Concord grape juice (8 oz. consumed 2 times per day; total dose of approximately 1.2 g phenolic compounds per day), 250 mg resveratrol provided as a capsule (commercially available supplement; 125 mg consumed 2 times per day), and 1 g grape seed polyphenol extract provided as a capsule (commercially available supplement; 0.5 g consumed 2 times per day).
16153658|NCT01751737|Procedure|Prostate Cancer Imaging|After imaging is completed, subjects will be scheduled for a prostate biopsy performed as part of their clinical care. If the imaging has identified suspicious lesions in the prostate, these regions will be made visible for the Urologist to be targeted for additional biopsies. These additional biopsies will undergo histological evaluation and further metabolomic testing to better understand metabolic differences between various grades of prostate cancer lesions.
16153659|NCT01751724|Drug|Caffeine citrate|"Enrolled subjects will be randomized to receive a study drug consisting of either blinded Caffeine citrate.
~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.
~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.
~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
16153660|NCT01751724|Other|Normal saline|"Enrolled subjects will be randomized to receive a study drug consisting of blinded Placebo (equivalent volume of normal saline).
~Randomization and study drug preparation will be done by the NICU pharmacy. Investigators and clinicians will be blinded to the assigned drug.
~After randomization, an initial loading dose of 20 mg/Kg of study drug will be followed by a 5 mg/Kg/day maintenance dose. The assigned study drug will be administered intravenous or orally as determined by the clinical team.
~Infants will continue to receive the study drug until 12 hours prior to the first elective extubation."
16153661|NCT01751698|Behavioral|JASP-EMT|JASP-EMT is a developmentally anchored behavioral intervention that assumes that communication develops from social interactions in which specific social engagement strategies, symbolic representations, and early communication forms are modeled and naturally reinforced by adult partner responses to the child. The goal of JASP-EMT is to increase (a) joint engagement, (b) initiating joint attention gestures, (c) social play involving objects and persons, and (d) verbal and nonverbal communication by facilitating meaningful social interactions. The social interaction foundation of JASP-EMT is critical. Modeling and expansions of communicative behaviors and play are used strategically within meaningful social interactions with therapists and caregivers.
16153662|NCT01751698|Behavioral|DTT|CORE-DTT is based on behavioral learning theory in which communication and related skills are taught through systematic direct instruction. The goal of CORE-DTT is to help children be successful in learning communication skills by breaking these skills down into small steps, providing systematic direct instruction on each step, and reinforcing children (e.g., with praise or access to preferred items) for demonstrating skills. Imitation and attention skills are a main focus early in intervention. DTT is the most common evidence-based approach for teaching children with ASD, and is often considered the closest to a 'standard of practice' for the field.
16153663|NCT01751685|Behavioral|Kyphosis-specific spinal strengthening exercises|Investigator developed the intervention protocol (Kyphosis-specific spinal strengthening exercises) of targeted spine exercises during our pilot study based upon the literature and clinical experience.We standardized the protocol with a written script and a video. Each exercise session will be preceded by light aerobic activity, ended with cool-down and stretching the neck, chest and all extremities. All participants will be carefully monitored to ensure that all exercises will be performed slowly, with correct body alignment and technique to minimize risk of injury.
16153664|NCT01751685|Other|Control|monthly educational lectures on various topics
16153665|NCT01751672|Behavioral|SBIRT|Screening, Brief Intervention, and Referral to Treatment. Standard, single session SBIRT.
16153666|NCT01751672|Behavioral|SBIRT+|Expanded Screening, Brief Intervention, and Referral to Treatment. One Standard SBIRT session, plus 2-6 additional Brief Intervention sessions as needed.
16153667|NCT01751646|Dietary Supplement|Vitamin D3 50,000 IU|Group A: Vitamin D3 50,000 IU orally every four weeks by DOT
16153668|NCT01751646|Dietary Supplement|Vitamin D3 placebo|Group B: Vitamin D3 placebo orally every four weeks by DOT
16153669|NCT01751633|Procedure|Surgical|
16153670|NCT01751633|Procedure|Conservative treatment|
16153671|NCT01751620|Behavioral|Project ACCEPT|The intervention, Project ACCEPT, combines weekly individual and group sessions that address a range of issues that impact engagement in care for youth living with HIV, including stigma, disclosure, health relationships, substance use, and future life plans.
16153672|NCT01751620|Behavioral|HEALTH|The comparison condition, HEALTH, matches Project ACCEPT in number of sessions and duration. The weekly sessions will cover information on alcohol, drugs, HIV and other sexually transmitted diseases (STDs) to meet the ethical responsibility to provide risk reduction information to youth assigned.
16153708|NCT01751334|Device|total knee arthroplasty|Mobile Bearing Total knee Arthroplasty
16153709|NCT01751334|Device|total knee arthroplasty|Fixed Total Knee Arthroplasty
16153986|NCT01749189|Dietary Supplement|Whey|22 grams of protein/day
16153673|NCT01751594|Behavioral|MOVE Intervention|MOVE involves four sessions. Sessions 1 and 2 occur over a two-day time frame and are each one day long (approximately 8 hours in length). They will: lay the groundwork for the intervention; provide HIV and other sexual health-related information; introduce critical consciousness; Sessions 1 and 2 will begin the enhancement of critical consciousness and the action-reflection-action cycle. Sessions 3 and 4 are also one-day sessions each (approximately 8 hours in length) and will be administered at one month intervals following the completion of sessions 1 and 2. These sessions will be used to provide continued enhancement of critical consciousness and guided support, feedback, and social reinforcement for behavior change and self-efficacy related to increasing health-promoting behaviors and reducing HIV-related health risk behaviors.
16153674|NCT01751594|Behavioral|H4L Comparison Intervention|Health 4 Life (H4L) is a comparison intervention which will serve as the basis of comparison for Mobilizing Our Voices for Empowerment (MOVE), the treatment intervention. H4L will be a health promotion and life skills intervention to account for time and attention.
16153675|NCT01751581|Behavioral|Short Sleep|Participants will be restricted in sleep and only allowed to sleep from 1 am to 5 am.
16153676|NCT01751581|Behavioral|Habitual sleep|Participants sleep 8 h/night throughout the study phase (from 11 pm to 7 am)
16153677|NCT01751568|Drug|Raltegravir|Chewable raltegravir tablets, initially dosed at 12 mg/kg (up to a maximum of 800 mg) orally twice daily.
16153678|NCT01751555|Drug|Regimen:TDF+3TC+EFV|TDF+3TC+EFV for HIV/HBV co-infection
16153679|NCT01751542|Behavioral|Mindfulness + Residential Treatment|
16153680|NCT01751542|Behavioral|Residential treatment alone|
16153681|NCT01751529|Procedure|Contrast-enhanced Ultrasound|All patients will undergo a contrast-enhanced ultrasound prior to planned resection or ablative therapy or as part of routine screening for kidney cancer.
16153682|NCT01751529|Drug|Perflutren lipid|All patients will receive a contrast-enhanced ultrasound using microbubble contrast agent (perflutren lipid; Definity®) prior to planned resection or ablative therapy or as part of routine screening for kidney cancer.
16153683|NCT01751503|Procedure|Interosseous route of TPTT|Anterior transposition of Posterior tibialis tendon (PTT) is the gold standard for surgical restoration of functional dorsiflexion of a permanently paralyzed foot. Two methods of rerouting the posterior tibialis tendon have been reported, one through the interosseous membrane i.e. Interosseous route and second subcutaneously around the medial side of tibia i.e. Extramembranous or circumtibial route. Both these techniques have been widely described in literature and are being extensively used in surgical management of foot drop. The selection of technique depends on surgeon choice and patient factors
16153684|NCT01751503|Procedure|Extra membranous route of TPTT|Rerouting the posterior tibialis tendon subcutaneously around the medial side of tibia i.e. Extramembranous or circumtibial route (
16153685|NCT01751490|Other|physiotherapy|physiotherapy
16153686|NCT01751490|Procedure|shoulder stabilisation surgery|arthroscopic stabilisation surgery
16153687|NCT01751464|Behavioral|WrapAround Case Management|Youth Injured by Violence will be paired with a support worker who has extensive experience working with youth affected by violence.It is important to note that the wraparound concept involves individualized care planning and management. As such, the specific care plan will be different for each participant. Through early intensive meetings, they will develop a mentoring relationship. They will work with the youth to develop a support team, which may include family, teachers, child welfare workers and truly anyone the youth has decided can help them in their path to making positive choices.
16153688|NCT01751451|Drug|Abiraterone acetate|Patients randomized to abiraterone acetate and prednisone (Group 1) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day. These patients will also be treated with prednisone 5 mg once daily with food.
16153689|NCT01751451|Drug|Abiraterone acetate plus degarelix|Patients randomized to abiraterone acetate plus degarelix and prednisone (Group 2) will be instructed to take 1000 mg (four 250 mg tablets) of abiraterone acetate orally (PO) at least 1 hour before a meal and 2 hours after a meal every day and prednisone 5 mg once daily with food. Patients will also be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1(starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (±3 days) thereafter.
16153690|NCT01751451|Drug|Degarelix|Patients randomized to degarelix alone (Group 3) will be given two subcutaneous injections of degarelix 120 mg on Cycle 1, Day 1 (starting dose) and 80 mg subcutaneous doses (maintenance doses) every 28 days (± 3 days) thereafter.
16153691|NCT01751438|Other|Best Systemic Therapy (BST)|Group 1 will continue to receive best systemic therapy (BST).
16153692|NCT01751438|Other|Best Systemic Therapy (BST) + Surgery or Radiation Therapy|Group 2 will receive best systemic therapy in addition to surgery to remove prostate or radiation therapy to the prostate. Treating physician will decide if surgery or radiation therapy is the best choice.
16153693|NCT01751438|Behavioral|Questionnaires|Questionnaire completion at 60 days, 12 weeks, and at end of treatment visit. It should take about 15 minutes to complete.
16153694|NCT01751438|Other|Phone Call/Email|Every 6 months after end-of-treatment visit, patient contacted by phone or e-mail and asked questions about how they are feeling. Each phone call should last about 5 minutes.
16153695|NCT01751425|Drug|Dasatinib|Given PO
16153696|NCT01751425|Drug|Imatinib Mesylate|Given PO
16153697|NCT01751425|Drug|Nilotinib|Given PO
16153698|NCT01751425|Drug|Ruxolitinib|Given PO
16153699|NCT01751412|Radiation|Proton Radiation|
16153700|NCT01751399|Drug|LY2605541|
16153701|NCT01751386|Drug|Baclofen|
16153702|NCT01751386|Other|Placebo|
16153703|NCT01751373|Behavioral|Optimal muscle activation therapy|The proposed study uses a longitudinal, within-subject, pre/post intervention, cross-over design. All participants will complete each of 4 study phases (each 12 weeks long). These include: a) focal BTX injections in combination with either Standard Therapy or Optimal Muscle Activity Therapy; b) a three-month period where no treatment is given; c) focal BTX injections in combination either Standard Therapy or Optimal Muscle Activation Therapy; d) another three-month period where no treatment is given. The order of treatment phases will be counter-balanced across participants.
16153704|NCT01751373|Behavioral|Standard Therapy|
16153705|NCT01751360|Drug|SYR-472|
16153706|NCT01751347|Drug|Bupivacaine|Local anesthetics
16153707|NCT01751347|Drug|Lidocaine|Local anesthetics
16153816|NCT01750476|Drug|Oral contraception|
16153710|NCT01751321|Drug|Sitagliptin, placebo|sitagliptin 50 / metformin 1000 twice in a day and placebo 50 mg /metformin 1000 twice in a day
16153711|NCT01751308|Drug|Cabazitaxel (XRP6258)|Pharmaceutical form: Injection Route of administration: Intravenous
16153712|NCT01751295|Drug|Atorvastatin, pre-treatment 80 mg/day for 4 days before PCI|
16153713|NCT01751282|Genetic|Stem Cell|
16153714|NCT01751269|Drug|RPX7009|Ten (10) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation.
16153715|NCT01751269|Drug|Placebo|Ten (10) cohorts of 8 subjects (6 active and 2 placebo) are planned for evaluation.
16153716|NCT01751256|Device|Continuous wound infiltration|Subfascial continuous wound infiltration with Levobupivacaine: bolus 50mg and 6.25mg/h for 48 hours through a multiperforated catheter, in addition to Celecoxib 200mg twice a day, paracetamol 1g four times a day, Nefopam 20mg four times a day, and intravenous morphine for 24 hours with Patient Controlled Analgesia pump (1.2mg by bolus, 7 minutes lockout period).
16153717|NCT01751243|Other|Allo-depleted lymphocyte infusion|Doses: 1x105 CD3/Kg; 3x105 CD3/Kg; 5x105 CD3/Kg; 1x106 CD3/Kg;31x106 CD3/Kg;
16153718|NCT01751243|Other|Haploidentical transplantation of hematopoietic progenitors|Haploidentical transplantation of hematopoietic progenitors without subsequent infusion of allo-depleted lymphocytes.
16153719|NCT01751230|Behavioral|WIC E-Moms|Participants enrolled in the E-Moms group will receive a personalized dietary prescription to promote weight loss and arrive at pregravid weight by 6 months postpartum. Our weight loss intervention will incorporate standard WIC nutritional advice and will encouraged 150 minutes/week of moderate intensity activity, which is about 3,000 - 4,000 steps/day above baseline, as recommended for maintenance of healthy weight. Each participant will be assigned a trained weight management counselor who will provide frequent recommendations and advice and support at least once per week.
16153720|NCT01751217|Behavioral|Functional Family Tx|
16153721|NCT01751217|Behavioral|Services as Usual|
16153722|NCT01751204|Dietary Supplement|Calcium tablet|
16153723|NCT01751204|Dietary Supplement|Calcium ion water (250mg)|
16153724|NCT01751204|Dietary Supplement|Calcium ion water (125mg)|
16153725|NCT01751178|Drug|Chlorhexidine Digluconate Mouthwash with Alcohol|0.2% w/v Chlorhexidine Digluconate, alcohol containing - UK Marketed Mouthwash
16153726|NCT01751178|Drug|Chlorhexidine Digluconate Mouthwash without Alcohol|0.2% w/v Chlorhexidine Digluconate, without alcohol - UK Marketed Mouthwash
16153727|NCT01751165|Biological|Herpes zoster vaccine GSK1437173A|2 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
16153728|NCT01751152|Drug|NNC0114-0006|A single i.v. (intravenous, into the vein) dose. At week 12 the possibility to administer an additional open-label dose of NNC0114-0006 will be provided to all subjects irrespective of initial treatment allocation as long as they are not in need of rescue medication, as judged by the clinical investigator.
16153729|NCT01751152|Drug|placebo|A single i.v. (intravenous, into the vein) dose. At week 12 the possibility to administer an additional open-label dose of NNC0114-0006 will be provided to all subjects irrespective of initial treatment allocation as long as they are not in need of rescue medication, as judged by the clinical investigator.
16153730|NCT01751139|Procedure|Blood sample collection|Blood samples will be collected at each study visit (Day 0, Month 6, Month 12, Month 24, Month 36 and Month 48) and any time during the study that dengue is suspected. Samples collected at scheduled visits will be tested for anti-dengue antibodies. Samples collected at visits for dengue suspicion will be tested for dengue infection diagnosis.
16153731|NCT01751139|Other|Data collection|Diary logs will be issued to all subjects at every visit, except Month 48 (Day 0, Month 6, Month 12, Month 24, and Month 36), as required. Any completed diary logs will be verified, as applicable. Subjects will be given a diary log in the event of the occurrence of a symptom that may be associated with suspected dengue.
16153732|NCT01751126|Drug|NOVA22007 ''Ciclosporin''|Sterile, ophthalmic cationic oil-in-water emulsion containing 1 mg/ml Ciclosporin.
16153733|NCT01751126|Drug|Placebo|Sterile, drug-free, cationic ophthalmic oil-in-water emulsion containing 0 mg/ml Ciclosporin.
16153734|NCT01751113|Drug|fluticasone propionate/salmeterol|250mcg fluticasone + 50 mcg salmeterol, twice daily 4 week treatment in each treatment sequence (crossover design)
16153735|NCT01751113|Drug|tiotropium bromide|18 mcg tiotropium bromide, once daily 4 week treatment in each treatment sequence (crossover design)
16153736|NCT01751113|Drug|fluticasone propionate/salmeterol plus tiotropium bromide|250mcg fluticasone + 50 mcg salmeterol, twice daily plus 18 mcg tiotropium bromide, once daily 4 week treatment in each treatment sequence (crossover design)
16153737|NCT01751100|Behavioral|HIV Test Offer|HIV education and counseling from a trained Research Assistant and offering of a free rapid, oral HIV test
16153738|NCT01751100|Behavioral|General Health Screen Offer|A Research Assistant (RA) will provide health education on diabetes, hypertension, and HIV. The RA will then offer free blood pressure check, blood glucose measuring, rapid Hepatitis C (HCV) test, and a free, rapid oral HIV test.
16153739|NCT01751087|Other|Mifepristone|oral mifepristone 200 mg on Day 1.
16153740|NCT01751087|Drug|misoprostol|buccal misoprostol 400 mcg on Day 2
16153741|NCT01751087|Device|Osmotic dilators|osmotic dilators on Day 1
16153742|NCT01751087|Other|placebo|placebo for mifepristone, on day 1
16153743|NCT01751087|Other|placebo|placebo for misoprostol, on day 2
16153744|NCT01751074|Drug|Rosuvastatin 10 mg|Enteric coated tablet will be administered orally as a single dose once in Treatment Period 1 (Day 1) and Treatment Period 2 (Day 15).
16153745|NCT01751074|Drug|Darapladib 160 mg|Enteric coated tablet will be administered orally as once daily for 14 days in Treatment Period 2 only (Day 5 to Day 18).
16153746|NCT01751061|Behavioral|Decision aid|A web-based decision aid to assist surrogate decision makers in prolonged mechanical ventilation decisions
16153747|NCT01751061|Other|Usual care|usual ICU care
16153748|NCT01751048|Biological|GLA-SE|Glucopyranosyl Lipid A- Stable oil-in-water emulsion (GLA-SE) is formulated in a stable oil-in-water emulsion (SE) to yield the adjuvant formulation GLA-SE. The combination of GLA-SE with a recombinant protein antigen (LEISH-F3) results in a Th1-type T cell response. GLA-SE appears as a milky- white liquid. 16 subjects receive vaccine on day 0, 28, and 168 of 0.5 ml of 20 mcg of LEISH-F3 + 5 mcg GLA-SE.
16153817|NCT01750476|Drug|Depo-Provera|
16153987|NCT01749189|Dietary Supplement|Placebo|22 grams of carbohydrate/day
16153749|NCT01751048|Biological|LEISH-F3|LEISH-F3 is a lyophilized formulation containing 50 mcg LEISH-F3 and excipients (mannitol, sucrose, and polysorbate 80). All subjects receive vaccine on day 0, 28, and 168 of 0.5 ml of 20 mcg of LEISH-F3.
16153750|NCT01751048|Biological|MPL-SE|Monophosphoryl Lipid A-Stable oil-in-water emulsion (MPL-SE) is an oil-in-water emulsion that contains Monophosphoryl Lipid A, an attenuated form of Lipid A from Salmonella Minnesota R595 in a emulsion (SE). The combination of MPL-SE with a recombinant protein antigen (LEISH-F3) results in a TH1-type T cell response. MPL-SE appears as a milky-white liquid. 16 subjects receive vaccine on day 0, 28, and 168 of 0.5 ml of 20 mcg of LEISH-F3+10 mcg MPL-SE.
16153751|NCT01751048|Drug|SE|Stable oil-in-water Emulsion (SE) is a squalene oil-in-water emulsion that has adjuvant properties of its own, but in a Th2-dependent manner. SE appears as milky-white liquid. 16 subjects receive vaccine on day 0, 28, and 168 of 0.5 ml of 20 mcg LEISH-F3 + SE.
16153752|NCT01751035|Behavioral|Risk Reduction through Family Therapy|RRFT is an integrative, ecologically-based approach to risk reduction and treatment. A Stage 1a feasibility trial and a Stage 1b pilot randomized controlled trial (RCT) evaluating RRFT have been completed. This Stage 1 work has resulted in a treatment manual, a clinician training protocol, and a quality assurance system. Preliminary findings from these studies are promising, indicating that RRFT can be readily learned and implemented with fidelity, and that it can lead to improvements in drug use and drug use-related risk and protective factors, PTSD symptoms, and risky sexual behaviors.
16153753|NCT01751035|Behavioral|Treatment as Usual|Participants assigned to the TAU condition will receive the standard treatment that a CSA victim would typically receive at community advocacy centers. In addition to treatment that is typically offered at the CACs, this will include a referral for substance abuse evaluation and may include referrals to other agencies in the community. TAU has been utilized as a comparison condition for several behavioral treatment evaluations involving adolescent substance abuse.
16153754|NCT01751022|Device|Device: Attain Performa Pacing Lead (along with a standard CRT-D system)|Implant and follow-up of study lead, separate analysis for each lead model
16153755|NCT01751009|Dietary Supplement|Vitamin A supplements|Sprinkles with Vitamin A
16153756|NCT01751009|Dietary Supplement|Sprinkles without Vitamin A|Active comparator
16153757|NCT01750996|Behavioral|Strongest Families|Behavioural intervention
16153758|NCT01750983|Drug|Ipilimumab|"Dose Escalation Group Starting Dose: 1.5 mg by vein over 90 minutes on Day 1 of each 28 day cycle.
~Dose Expansion Group Starting Dose for Ipilimumab: Maximum tolerated dose (MTD) from Dose Escalation Group."
16153759|NCT01750983|Drug|Lenalidomide|"Dose Escalation Group Starting Dose: 10 mg by mouth on Days 1-21 of each 28 day cycle.
~Dose Expansion Group Starting Dose for Lenalidomide: Maximum tolerated dose (MTD) from Dose Escalation Group."
16153760|NCT01750970|Other|Endoscopic resection under blue light (Hexvix®)|Endoscopic resection
16153761|NCT01750957|Drug|Placebo|orally daily, 12 weeks
16153762|NCT01750957|Drug|RO4917523|Dose A orally daily, 12 weeks
16153763|NCT01750957|Drug|RO4917523|Dose B orally daily, 12 weeks
16153764|NCT01750944|Procedure|Ankle first|"Brachial blood pressure on both the left and right (BBP-LR) sides is measured, as well as at the left and right ankles (BPA-LR).
~A 15 minute walking test (WT) is performed.
~BBP-LR and BPA-LR are re-measured.
~2 hours of rest.
~BBP-LR and the blood pressure at the left and right big toes (BPT-LR) are measured.
~WT is reperformed.
~BBP-LR and BPT-LR are re-measured."
16153765|NCT01750944|Procedure|Toe first|"Brachial blood pressure on both the left and right (BBP-LR) sides is measured, as well as at the left and right big toes (BPT-LR).
~A 15 minute walking test (WT) is performed.
~BBP-LR and BPT-LR are re-measured.
~2 hours of rest.
~BBP-LR and the blood pressure at the left and right ankles (BPA-LR) are measured.
~WT is reperformed.
~BBP-LR and BPA-LR are re-measured."
16153766|NCT01750931|Drug|Meloxicam GSK 15mg|To demonstrate the bioequivalence of Meloxicam 15 mg tablets manufactured by Savipharm J.S.C, Vietnam and Mobic® 15 mg tablets of Boehringer Ingelheim Pharma GmbH &amp; Co.KG Binger Str.173, 5521 Ingelheim am Rhein, Germany, in healthy adult human male subjects under fed condition
16153767|NCT01750931|Drug|Mobic 15mg|To demonstrate the bioequivalence of Meloxicam 15 mg tablets manufactured by Savipharm J.S.C, Vietnam and Mobic® 15 mg tablets of Boehringer Ingelheim Pharma GmbH & Co.KG Binger Str.173, 5521 Ingelheim am Rhein, Germany, in healthy adult human male subjects under fed condition
16153772|NCT01750905|Drug|CD-NP|CD-NP 5 ug/kg subcutaneous injection (SQ)
16153773|NCT01750905|Drug|Placebo|Vehicle (D5W) SQ
16153774|NCT01750892|Behavioral|REACH for Independence|REACH for Independence is a transition and self-care skill-building peer support group led by a social worker. It is comprised of two 2.5-hour group sessions where participants participate in activities designed to teach self-care, self-advocacy and improve transition to adulthood skills.
16153775|NCT01750892|Behavioral|Transition Consult|The transition consult is a 1-on-1 visit with an MD and social worker. At the consults, participants will receive individualized information related to their unique medical and psychosocial needs and support related to issues relevant to their gaining healthcare independence and finding an adult doctor, such as accommodations, transportation, insurance and finances. After the consult, this group will have access to a transition coordinator who can help with any transition-related problems that may occur.
16153874|NCT01750073|Radiation|Radiation Therapy|Undergo RT
16153875|NCT01750073|Procedure|Therapeutic Conventional Surgery|Undergo mastectomy or breast conserving surgery
16153876|NCT01750073|Biological|Trastuzumab|Given IV
16153776|NCT01750892|Other|Study Materials|The Study Materials include a Care Binder, a Resource list, an Adult Doctor List and a Wallet Card. The Care Binder is an organizational tool to help patients with special healthcare needs manage and track important information related to their health and medical care. The Resource list has information about important community resources. The Adult Doctor List provides information about finding an adult primary care provider. The Wallet Card is a sheet for tracking important medical and personal information.
16153777|NCT01750879|Drug|Peanut Flour|Peanut Flour
16153778|NCT01750879|Drug|Oat Flour|Oat Flour
16153779|NCT01750866|Drug|Cabazitaxel|Cabazitaxel 25 mg/m2 will be administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
16153780|NCT01750866|Drug|Prednisone|Prednisone 10 mg on Day 1 of the first cycle and continue taking 10 mg po daily for the entire cycle.
16153781|NCT01750866|Drug|Granulocyte colony-stimulating factor (G-CSF)|Granulocyte colony stimulating factor (Neulasta 6 mg sc) with each cycle, starting with the first cycle, to minimize the risk of complications from neutropenia.
16153782|NCT01750853|Drug|LY3045697|Administered orally
16153783|NCT01750853|Drug|Placebo|Administered orally
16153784|NCT01750840|Device|Biomet® EBI Bone Healing System|A pulsed electromagnetic fields electrical stimulation device used for the treatment of fracture nonunions. Designed to be used for 3-10 hours per day with a recommended use of 10 hours per day.
16153785|NCT01750840|Device|Biomet Orthopak® Non-Invasive Bone Growth Stimulator System|A capacitive coupling electrical stimulation device used for the treatment of fracture nonunions. Designed to be used for 24 hours per day.
16153786|NCT01750840|Device|Biomet SpinalPak® Non-Invasive Spine Fusion Stimulator|A capacitive coupling electrical stimulation device used as an adjunctive treatment to lumbar spinal fusion. Designed to be used for 24 hours per day.
16153787|NCT01750827|Drug|SB659032|single dose
16153788|NCT01750814|Biological|GC3102C|a single dose (0.5 mL) intramuscularly on the deltoid muscle
16153789|NCT01750814|Biological|GC FLU inj.|a single dose (0.5 mL) intramuscularly on the deltoid muscle
16153790|NCT01750801|Drug|Propolis|Twenty-five subjects, both male and female, were chosen after signing the terms of agreement.. The criteria for selection stated that subjects should be from 18 to 60 years old, should present good health, a minimum of 20 teeth and not be pregnant or breastfeeding.The subjects went through a dental prophylaxis before starting rinse. They were then instructed to rinse twice a day for a minute, immediately after brushing (morning and night), using the 10 ml of the MGP 5%. After 45 and 90 days using the product the individuals returned for a clinical evaluation which considered changes in the soft and hard oral tissues and involved collecting plaque and gingivitis indexes. On their last appointment the subjects answered a questionnaire about their level of appreciation and acceptability of the mouthwash
16153791|NCT01750801|Drug|chlorhexidine|Twenty-five subjects, both male and female, were chosen after signing the terms of agreement.The subjects went through a dental prophylaxis before starting rinse. They were then instructed to rinse twice a day for a minute, immediately after brushing (morning and night), using the 10 ml of the MGP 5%. After 45 and 90 days using the product the individuals returned for a clinical evaluation which considered changes in the soft and hard oral tissues and involved collecting plaque and gingivitis indexes. On their last appointment the subjects answered a questionnaire about their level of appreciation and acceptability of the mouthwash
16153792|NCT01750788|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism. Decision regarding dose and duration of treatment made at the discretion of the attending investigator.
16153793|NCT01750775|Drug|Shensong Yangxin capsule|ShenSongYangXin Capsule 4 granules t.i.d. by mouth for 8 weeks
16153794|NCT01750775|Drug|placebo Capsule|placebo Capsule 4 granules t.i.d. by mouth for 8 weeks
16153795|NCT01750762|Drug|Lenalidomide|
16153796|NCT01750749|Biological|Autologous BMDC implantation at the venous ulcer|An autologous bone marrow derived cell concentrate is obtained by bone marrow harvest (300 ml) from the iliac crest and subsequent processing using 6% hydroxyethyl starch to concentrate nucleated cells. The cells are injected using a 27 Gauge needle, in aliquots of 0.2 ml, along the venous ulcer edge. SOC treatment consisting of advanced wound management plus pressure therapy is administered simultaneously.
16153797|NCT01750736|Other|Augmented Exercise and Manual Therapy|Session 1 will include the manual therapy intervention to cervical and or thoracic regions. Subjects will perform the augmented exercise at home and at each data collection session.
16153798|NCT01750736|Other|General Exercise and Manual Therapy|Session 1 will include the manual therapy intervention to cervical and or thoracic regions. Subjects will perform general range of motion exercises for the neck at home and at each data collection session.
16153799|NCT01750723|Drug|Acetazolamide|1 g diluted in 10 ml saline, i.v. bolus injection.
16153800|NCT01750697|Drug|Rituximab|Participants will receive rituximab 375 mg/m^2 IV infusion on Days 1, 8, 15 and 22. Rituximab infusions will be given at a rate of 25 milligrams per hour (mg/h). This may be escalated at a rate of 25 mg/h increments every 30 minutes to a maximum of 200 mg/h.
16153801|NCT01750684|Drug|AC105|
16153802|NCT01750684|Other|Placebo|
16153803|NCT01750645|Drug|Intradetrusor Injection of Type-A Botulinum Toxin|
16153804|NCT01750645|Other|Other interventions analyzed according to protocol|"Placebo
~Different dosage of Type-A Botulinum Toxin injected
~Anticholinergic drugs"
16153805|NCT01750632|Procedure|Orchiectomy|The patients undergo subcapsular orchiectomy with basic surgical instruments. The patients are given local analgesia and sometimes universal anesthesia.
16153806|NCT01750593|Procedure|Radiofrequency ablation of the thyroid nodule|Under USG control, the nodule will be ablated by radiofrequency with a needle that has an active tip of 1 cm.
16153807|NCT01750580|Drug|Lirilumab|
16153808|NCT01750580|Drug|Ipilimumab|
16153809|NCT01750567|Drug|Metformin|Metformin is an antidiabetic drug which is an inexpensive and generally well tolerated medication.
16153810|NCT01750554|Other|intermediate-acting digital nerve block|non-therapeutic Bupivacaine digital nerve block to assess effect on accuracy of diagnostic readings
16153811|NCT01750541|Drug|Haloperidol|
16153812|NCT01750541|Drug|Valproate|
16153813|NCT01750515|Device|Acupuncture|
16153814|NCT01750489|Device|non-invasive ventilation (NIV)|
16153815|NCT01750476|Drug|Mirena|
16153818|NCT01750463|Other|Masimo Pronto Rad 7 Non-Invasive hemoglobin monitor|Patients admitted to PICU requiring hemoglobin monitoring will have a total hemoglobin (SpHb) assessment from Masimo non-invasive monitor, prior to standard, required blood draw and laboratory analysis.
16153819|NCT01750463|Other|Standard Laboratory Blood Draw and Hemoglobin Analysis|Patients admitted to PICU requiring hemoglobin monitoring will have a reading from Masimo non-invasive monitor, prior to standard, required blood draw and laboratory analysis.
16153820|NCT01750437|Drug|YH1885L(Revaprazan)|
16153821|NCT01750437|Drug|Esomeprazole 20mg|
16153822|NCT01750437|Drug|placebo|
16153823|NCT01750424|Procedure|Autologous Fat Grafting|
16153824|NCT01750424|Other|No intervention|Subjects in this arm will only be followed up and have no procedure performed.
16153825|NCT01750398|Drug|Testosterone cypionate|DEPO-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble of the androgenic hormone testosterone. Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. DEPO-Testosterone Injection is available in two strengths, 100 mg/mL and 200 mg/mL testosterone cypionate.
16153826|NCT01750398|Drug|Goserelin|"Goserelin is a hormone therapy, for intramuscular injectionis. It is classified as an LHRH agonist."
16153827|NCT01750398|Drug|Leuprolide|Leuprolide is a gonadotropin-releasing hormone (GnRH) agonist. For intramuscular injection.
16153828|NCT01750385|Drug|no antibiotic prophylaxis|These patients are in no antibiotic prophylaxis group will not be administered antibiotic prophylactically.
16153829|NCT01750385|Drug|second-generation cephalosporin|These patients are in antibiotic prophylaxis group will be administered second-generation cephalosporin prophylactically.
16153830|NCT01750359|Drug|curcumin|500 mg/day for 6 week
16153831|NCT01750346|Drug|Topical acetyl hexapeptide-8|
16153832|NCT01750346|Drug|Placebo|
16153833|NCT01750320|Device|Koning Breast CT-guided Biopsy|The breast will be positioned and stabilized in the grid/compression device. Four KBCT scans will be taken to guide the vacuum-assisted biopsy procedure.
16153834|NCT01750307|Dietary Supplement|Experimental fatty acid supplementation|4 x capsules per day. Daily dose: 1584mg EFA
16153835|NCT01750307|Dietary Supplement|Placebo comparator: MCT oil softgel|4 x capsules per day. Medium chain triglyceride pill manufactured to mimic essential fatty acid pill
16153836|NCT01750294|Drug|Chlorthalidone|
16153837|NCT01750281|Drug|Selumetinib 75 mg|Three selumetinib capsules (Hyd-Sulfate) 25 mg will be administered orally, twice daily, (75 mg dose bd) on an uninterrupted schedule.
16153838|NCT01750281|Drug|Docetaxel 75 mg/m2|Docetaxel 75 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.
16153839|NCT01750281|Drug|Docetaxel 60 mg/m2|Docetaxel 60 mg/m2 will be administered intravenously on day 1 of each 21 day cycle.
16153840|NCT01750281|Drug|Placebo|Three placebo capsules will be administered orally uninterrupted twice daily.
16153841|NCT01750268|Behavioral|Medical Management Counseling|Brief alcohol and medication counseling
16153842|NCT01750268|Drug|Topiramate|Experimental medication
16153843|NCT01750268|Drug|Placebo|Placebo comparator
16153844|NCT01750255|Other|Pharmaceutical Care|Pharmaceutical care will be provided according to Dader Method for pharmaceutical care and will be carried out in collaboration with patients and physicians.The time between admission to the group and 20 days,the pharmacist will enhance the information related to treatment adherence and investigate by criteria to make an approach to the effectiveness and safety of treatment, through phone calls(weeks 1,3, 4-6) and a home visit(week 2). Pharmacist will call the patient weekly in order to increase adherence. At each appointment will assess of parameters of efficacy; Depression and Mania Rating Scale, Clinical Global Assessment Scale, Quality of life and adherence to treatment
16153845|NCT01750255|Other|Education|The control group will receive the usual care and verbal and written information and education about mental health and bipolar disorder for patients and their families. The written material is a brochure designed for this purpose, which focused on the goals and importance of adherence with pharmacological and nonpharmacological interventions to achieve treatment goals. Patients met again with the pharmacist every three months during one year. At each appointment will assess of parameters of efficacy and safety. Quality of life (Sf - 36 test), adherence to treatment, the severity of depressive symptoms in individuals, Symptoms of Mania, the psychiatrist rated patient impairment.
16153846|NCT01750242|Device|Medtronic DBS system|Advanced Parkinson's disease patients implanted with the Medtronic Deep Brain Stimulation (DBS) system.
16153847|NCT01750229|Device|Sham|Frequency Setting - Sham
16153848|NCT01750229|Device|1200 Hz|Frequency Setting - 1200 Hz
16153849|NCT01750229|Device|3030 Hz|Frequency Setting - 3030 Hz
16153850|NCT01750229|Device|5882 Hz|Frequency Setting - 5882 Hz
16153851|NCT01750203|Other|Swabs|There is no intervention only swabs are being used to collect wound fluid samples
16153852|NCT01750190|Drug|Roxadustat|Oral tablets
16153853|NCT01750190|Drug|Placebo|Oral tablets
16153854|NCT01750177|Behavioral|Television Viewing before mealtime|
16153855|NCT01750177|Behavioral|Video Game Playing|
16153856|NCT01750177|Behavioral|Computer Use|
16153857|NCT01750177|Behavioral|Sitting quietly|
16153858|NCT01750151|Dietary Supplement|Glucose Beverage|
16153859|NCT01750151|Behavioral|Video Game Playing|
16153860|NCT01750151|Dietary Supplement|Control Beverage|
16153861|NCT01750138|Drug|Glutamine|
16153862|NCT01750138|Drug|Dextrose powder|
16153863|NCT01750125|Device|measure ascending aortic blood flow with pulse wave Doppler|
16153864|NCT01750112|Device|Macrolane VRF20|Injection treatment with Macrolane VRF20
16153865|NCT01750099|Procedure|Combined Spinal-epidural|See arm description
16153866|NCT01750099|Procedure|Continuous Lumbar epidural|See arm description
16153867|NCT01750086|Drug|Teriparatide 40-mcg subcutaneous injection|
16153868|NCT01750086|Drug|Denosumab Injection|One-time Denosumab injection
16153869|NCT01750086|Drug|Alendronate Oral Tablet|weekly alendronate for 8 weeks
16153870|NCT01750073|Drug|Cyclophosphamide|Given IV
16153871|NCT01750073|Drug|Doxorubicin Hydrochloride|Given IV
16153872|NCT01750073|Other|Laboratory Biomarker Analysis|Correlative studies
16153873|NCT01750073|Drug|Paclitaxel|Given IV
16153879|NCT01750034|Procedure|Closed method|Subjects will have their wounds managed by covering with gauze and changing this gauze 3 to 7 times per week.
16153880|NCT01750034|Procedure|Open method|Subjects will have their burns managed by keeping the wounds exposed to the air.
16153881|NCT01750021|Dietary Supplement|High fat low carbohydrate diet|70E% fat, 20E% protein, 10E% carbohydrates
16153882|NCT01750021|Dietary Supplement|Low fat high carbohydrate diet|20E% fat, 20E% protein, 60E% carbohydrates
16153883|NCT01750008|Procedure|Global Fibroid Ablation|
16153884|NCT01750008|Procedure|Myomectomy|
16153885|NCT01749982|Other|Placebo|
16153886|NCT01749982|Drug|Choline bitartrate|
16153887|NCT01749982|Drug|Betaine|
16153888|NCT01749982|Drug|Choline bitartrate + Betaine|
16153889|NCT01749969|Drug|isatuximab SAR650984|Pharmaceutical form:solution Route of administration: intravenous
16153890|NCT01749969|Drug|lenalidomide|Pharmaceutical form:capsules Route of administration: oral
16153891|NCT01749969|Drug|dexamethasone|Pharmaceutical form:solution or tablet Route of administration: intravenous or oral
16153892|NCT01749956|Radiation|Radiation|
16153893|NCT01749956|Drug|Aflibercept|
16153894|NCT01749956|Procedure|Surgery|Abdominoperineal or low anterior resection with total mesorectal excision, per standard treatment guidelines
16153895|NCT01749956|Drug|FOLFOX6|
16153896|NCT01749930|Drug|BOL-303259-X|BOL-303259-X will be administered QD in the evening and its vehicle administered QD in the morning
16153897|NCT01749930|Drug|Timolol|Timolol will be administered BID once in the morning and once in the evening.
16153898|NCT01749930|Drug|BOL-303259-X|All participants will receive a topical ocular BOL-303259-X QD in the evening from 3 months (Visit 6) through 6 months (Visit7).
16153899|NCT01749917|Other|Exercise program|Exercise program An brief exercise session including proprioceptive and dexterity activities
16153900|NCT01749917|Other|Control intervention|Active upper limb range of movement exercises for 15 minutes.
16153901|NCT01749904|Drug|BOL-303259-X|Topical ocular BOL-303259-X will be administered QD in the evening and its vehicle administered QD in the morning for 3 months (visit 6).
16153902|NCT01749904|Drug|Timolol|Timolol will be administered BID once in the morning and once in the evening for 3 months (Visit 6)
16153903|NCT01749904|Drug|BOL-303259-X|All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)
16153904|NCT01749891|Drug|ALG 1001|Patients who will receive three, monthly intravitreal injections of 1.5mg, 2.5mg ,or 4.0 /50μl of ALG-1001 in 0.05cc in isotonic saline solution.
16153905|NCT01749878|Drug|REGN1500|
16153906|NCT01749878|Drug|placebo|
16153907|NCT01749865|Biological|Cytokine-Induced Killer Cells|Cytokine-Induced Killer Cells treatment for 4 cycles
16153908|NCT01749852|Other|Polyphenol-rich Dark chocolate|Participants will be asked to consume 20g of dark chocolate containing 500mg of polyphenols daily for a period of 12 weeks
16153909|NCT01749852|Other|Placebo Dark chocolate|Participants will be asked to consume 20g of dark chocolate containing little or no polyphenols for a period of 12 weeks
16153910|NCT01749826|Drug|Morphine Sulfate|15mg sustained release morphine sulfate, with a maximum dose of 120mg. Patients will be titrated up to a maximum dose of 8 pills a day for one month.
16153911|NCT01749800|Device|GVS|A small current is delivered to the vestibular system via electrodes placed over the subject's mastoid processes.
16153912|NCT01749800|Device|Sham GVS|Electrodes are placed over the subject's mastoid processes and connected to the device, but the device is not active.
16153913|NCT01749800|Device|Armeo Spring|A robotic system supports the weak arm of the subject to make it easier to perform therapeutic exercises.
16153914|NCT01749787|Drug|PRTX-100 at 1.5 mcg/kg|
16153915|NCT01749787|Drug|PRTX-100 at 3.0 mcg/kg|
16153916|NCT01749787|Drug|PRTX-100 at 6.0 mcg/kg|
16153917|NCT01749787|Drug|PRTX-100 at 12.0 mcg/kg|
16153918|NCT01749787|Drug|PRTX-100 at 240 mcg|
16153919|NCT01749787|Drug|Placebo|Placebo administered via infusion once per week for 5 weeks
16153920|NCT01749787|Drug|PRTX-100 at 420 mcg|
16153921|NCT01749774|Behavioral|Physical activity counseling|
16153922|NCT01749761|Other|BioLogic RR|Patients will be randomized to BP guided biofeedback arm which will entail regular hemodialysis with a software program turned on to allow frequent assessment of blood pressure and automated adjustments of the ultrafiltration rate based on these blood pressure measurements. The duration of this arm is 8 weeks
16153923|NCT01749761|Other|Hemodialysis without biofeedback|patients will be randomized to Standard HD (without biofeedback technology) for 8 weeks
16153924|NCT01749748|Procedure|proton magnetic resonance spectroscopy|proton magnetic resonance spectroscopy was performed for the normal breast to evaluate the chemical composition of breast
16153925|NCT01749735|Device|Transcranial Direct Current Stimulation|Continuous mild transcranial direct current stimulation will be used while the participant plays video games using the Armeo Spring Robot to support the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.
16153926|NCT01749735|Device|Sham Transcranial Direct Current Stimulation|Sham transcranial direct current stimulation will be used while the participant focuses on repetitive tasks using the Armeo device that incorporate multidirectional reaching, grasp and release action of the hand of the affected arm. Intervention: 40 minute training sessions, 5 days a week for 2 weeks.
16153927|NCT01749735|Device|Armeo training|Upper extremity training with the use of a weight support device and virtual reality.
16153928|NCT01749722|Device|NaviAid™ G-Eye procedure|NaviAid™ G-Eye procedure
16153929|NCT01749709|Behavioral|Music listening|
16153930|NCT01749657|Device|Arizona|Compare custom versus off-the-shelf devices for pain and function in subjects with stage II Posterior Tibial Tendon Dysfunction (PTTD).
16153931|NCT01749618|Behavioral|Education and Feedback|Rheumatologists are rated on how systematically they assess their patients, and receive six sessions of university accredited education about systematic assessments of patients with seronegative arthritis.
16153932|NCT01749605|Drug|Nitrofurantoin monohydrate/macrocrystals 100 mg BID x 3 days|
16153933|NCT01749605|Drug|ciprofloxacin 250 mg BID x 3 days|
16153934|NCT01749592|Device|cochlear implant|Surgical implantation of a cochlear implant device
16153935|NCT01749579|Drug|Propofol|Propofol 1 mg/kg bolus then 500 microg/kg every 2 minutes until sedation level equivalent to Ramsey 3
16153936|NCT01749579|Drug|Midazolam|Midazolam 0.03 mg/Kg stat and then the same dose repeated every 2 minutes until a sedation level of Ramsey 3 is achieved.
16153937|NCT01749579|Drug|Fentanyl|Fentanyl 2 microg/kg intravenous stat and every 2 minutes until the end of procedure
16153938|NCT01749566|Drug|maraviroc|Maraviroc administered at standard (300mg po bid) or reduced (300mg po daily) dosing
16153939|NCT01749553|Other|Sleeper Stretch|Posterior shoulder stretch technique
16153940|NCT01749540|Drug|ACE-536|Subjects receive ACE-536 administered subcutaneously (SC) every 3 weeks for up to 5 cycles.
16153941|NCT01749527|Behavioral|minimal activity|Pad test with minimal activity
16153942|NCT01749514|Drug|ACE-536|Subjects receive ACE-536 administered subcutaneously (SC) every 3 weeks for up to 5 cycles.
16153943|NCT01749501|Drug|Rocuronium|0.6 mg/Kg once
16153944|NCT01749501|Other|Placebo|Normal saline same amt as 0.6mg/kg of study drug
16153945|NCT01749488|Other|Designated dietitian for the ward|This is a randomized cluster trial. The centers randomized into this arm will designate a dietitian who will help the ward implement current recommendations for the nutrition of patients undergoing intensive care.
16153946|NCT01749475|Drug|Midazolam|The patients will be given 0.05mg/kg iv midazolam just before monitorization. During probing, in case of intolerance to the insertion of the probe, the increments of midazolam with 0.005mg/kg doses will be given.
16153947|NCT01749475|Other|hypnotherapy|A first hypnotic induction will be carried out the day before the procedure, next day, fifteen minutes before the procedure, a new induction will be performed.
16153948|NCT01749449|Other|protein and meal frequency|comparison of different levels of protein intake and meal frequency on body composition in obese adults
16153949|NCT01749436|Other|Lung ultrasound imaging examinations|Lung ultrasound examinations performed at different time-points immediately before surgery, during surgery under general anesthesia and after surgery in the recovery room to detect and monitor atelectasis related to laparoscopic procedures.
16153950|NCT01749423|Biological|OnabotulinumtoxinA|Previous treatment with onabotulinumtoxinA for Chronic Migraine.
16153951|NCT01749410|Biological|onabotulinumtoxinA|Previous treatment with onabotulinumtoxinA for Chronic Migraine.
16153952|NCT01749397|Drug|Floxuridine|Given IP
16153953|NCT01749397|Other|Laboratory Biomarker Analysis|Correlative studies
16153954|NCT01749397|Other|Pharmacological Study|Correlative studies
16153955|NCT01749397|Drug|Veliparib|Given IV
16153956|NCT01749384|Biological|Bevacizumab|Given IV
16153957|NCT01749384|Other|Laboratory Biomarker Analysis|Correlative studies
16153958|NCT01749384|Other|Pharmacological Study|Correlative studies
16153959|NCT01749384|Drug|Tivantinib|Given PO
16153960|NCT01749371|Drug|Vitamin E|1200 IU dl-alpha tocopheryl acetate after the initial excision surgery after admission (days 1-15 or days 16-30)
16153961|NCT01749358|Behavioral|Accelerated Skill Acquisition Program (ASAP)|A focused, intense, evidence-based, upper extremity rehabilitation program. The training intervention is based on the fundamental elements of skill acquisition through task-specific practice, impairment mitigation to increase capacity, and motivational enhancements to build self-confidence Dosage of therapy (number of hours of therapy) will vary based on group assignment. Frequency is 4x/week, 1 week per month for 3 months in a train-wait-train paradigm. A 2-hour orientation session precedes the first visit.
16153962|NCT01749358|Behavioral|Active Monitoring|This is an observation-only group. Any therapy received while in this group will be dosed according to usual and customary practice.
16153963|NCT01749332|Other|Perihepatic Phlebotomy|
16153964|NCT01749319|Drug|Oral baclofen|Each subject will receive one dose of oral baclofen and one dose of intravenous baclofen on different study days.
16153965|NCT01749319|Drug|Intervenous baclofen|
16153966|NCT01749306|Biological|ABH001|ABH001 applications topically every 4 weeks (±1 week) with protocol-specified dressings until wound healed or up to 44 weeks
16153967|NCT01749306|Other|Control wound treatment|Control wound care with protocol-specified dressings every 4 weeks (±1 week) up to 20 weeks with optional cross-over to ABH001 for additional 20 weeks
16153968|NCT01749293|Procedure|Haploidentical Transplant|Subjects will be dosed with pre-transplant Fludarabine (180mg/m2)and Busulfan total AUC 2400 μmol*min/L or 6.4mg/kg. Subjects will then undergo total body irradiation 2Gy. Subjects will undergo haploidentical allogeneic bone marrow transplant, followed by Cyclophosphamide, Tacrolimus and MMF based GVHD prophylaxis.
16153969|NCT01749293|Drug|Fludarabine|Subjects in this trial will receive Fludarabine 30 mg/m2 IV QD, adjusted for CrCl from Days -8 through -3.
16153970|NCT01749293|Drug|Busulfan|Subjects in this trial will receive Busulfan total AUC 2400 μmol*min/L or 6.4mg/kg in 4 doses with seizure prophylaxis from Days -6 through -3.
16153971|NCT01749293|Radiation|Total Body Irradiation|Subjects in this trial will receive total body irradiation (2Gy fractionated) from Day -2 or -1.
16153972|NCT01749293|Drug|Cyclophosphamide|Subjects in this trial will receive Cyclophosphamide 50 mg/kg IV QD on Days 3 and 4 post-transplant.
16153973|NCT01749267|Procedure|partial caries removal only at enamel dentin junction.|Partial caries removal only at enamel dentin junction (EDJ) without carious dentin removal at the pulpal site and restoration with glass ionomer cement(SMART restoration)
16153974|NCT01749241|Drug|Loteprednol etabonate ophthalmic ointment|Thin ribbon ointment to assigned eye twice daily for 14 days
16153975|NCT01749241|Drug|Vehicle Ophthalmic Ointment|Thin ribbon ointment to assigned eye twice daily for 14 days
16153976|NCT01749228|Drug|Etodolac Capsules USP 300 mg|300 mg capsule once a day
16153977|NCT01749228|Drug|Etodolac|500 mg tablet once a day
16153978|NCT01749215|Drug|Topiramate|Experimental study drug
16153979|NCT01749215|Drug|placebo|Placebo comparator
16153980|NCT01749215|Behavioral|Medical Management|Brief alcohol counseling
16153981|NCT01749202|Dietary Supplement|Sunflower Oil Softgels|3 x 500 mg softgel capsules/day
16153982|NCT01749202|Dietary Supplement|EPA softgels|3 x 500 mg softgel capsules/day
16153983|NCT01749202|Other|Sunflower Oil Food|3 servings/day
16153984|NCT01749202|Other|SDA soybean Oil Food|3 servings/day
16153985|NCT01749189|Dietary Supplement|Blend|22 grams of protein/day
16153988|NCT01749176|Behavioral|SMS texting intervention|
16153989|NCT01749176|Behavioral|Control-Usual Care|
16153990|NCT01749163|Biological|Saline|
16153991|NCT01749163|Biological|GIP|
16153992|NCT01749163|Biological|GLP-1|
16153993|NCT01749150|Drug|danoprevir + ritonavir|125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 12 weeks
16153994|NCT01749150|Drug|danoprevir + ritonavir|125 mg danoprevir + 100 mg ritonvir fixed-dose combination tablet, orally b.i.d., 24 weeks
16153995|NCT01749150|Drug|peginterferon alfa-2a [Pegasys]|180 mcg sc weekly, 12 weeks
16153996|NCT01749150|Drug|peginterferon alfa-2a [Pegasys]|180 mcg sc weekly, 24 weeks
16153997|NCT01749150|Drug|ribavirin [Copegus]|1000-1200 mg orally daily in divided doses, 12 weeks
16153998|NCT01749150|Drug|ribavirin [Copegus]|1000-1200 mg orally daily in divided doses, 24 weeks
16153999|NCT01749137|Drug|RM-493|
16154000|NCT01749137|Drug|Placebo|
16154001|NCT01749124|Device|My Coach Connect|Clients will call in to the system approximately twice a week for a period of four months. The study will be conducted in two phases. There will be an initial pilot phase where we will seek to enroll approximately 15-20 patients and 2-3 providers. This phase will last approximately two months and the goal will be to assess feasibility and obtain feedback on the tool and surveys to optimize them for this setting. We will begin the main phase of the study approximately one month after the end of the first phase and in that study seek to recruit approximately 150 patients and 5-10 providers from the ROADS program. Clients enrolled in this main phase of the study will enroll for a period of four months.
16154002|NCT01749111|Drug|ARM A Cyclophosphamide|Cyclophosphamide 50 mg/kg on day+3 and day+4 after bone marrow transplantation
16154003|NCT01749111|Drug|ARM B Calcineurin inhibitor and methotrexate|Graft versus host disease prophylaxis will be done with the combination of a calcineurin inhibitor (either tacrolimus or cyclosporine) and methotrexate
16154004|NCT01749098|Drug|PF-04958242|PF-04958242, 0.35 mg orally administered capsule on Day 1 and 0.25 mg orally administered capsule on Days 2 - 5
16154005|NCT01749098|Drug|Ketamine|At 60 minutes after the 0.25 mg dose of PF-04958242 on Day 5, Ketamine (0.23 mg/kg over 1 minute, followed by a maintenance rate of 0.58 mg/kg/hr for 75 minutes) will be infused.
16154006|NCT01749098|Drug|Placebo|Placebo capsule orally administered on Days 1 - 5
16154007|NCT01749098|Drug|Ketamine|At 60 minutes after Placebo on Day 5, Ketamine (0.23 mg/kg over 1 minute, followed by a maintenance rate of 0.58 mg/kg/hr for 75 minutes) will be infused.
16154008|NCT01749085|Drug|PF-04449913, ketoconazole|Subjects receive a 200 mg oral dose of PF-04449913 under fasted conditions with washout, then single 200 mg oral dose of PF-04449913 under fed with washout and finally a single 200 mg dose 0f PF-04449913 following dosing to steady state with ketoconazole
16154009|NCT01749085|Drug|PF-04449913, ketoconazole|Subjects receive a 200 mg oral dose of PF-04449913 under fed conditions with washout, then single 200 mg oral dose of PF-04449913 under fasted with washout and finally a single 200 mg dose of PF-04449913 following dosing to steady state with ketoconazole
16154010|NCT01749072|Drug|Gefitinib group|Gefitinib 250mg once per day until the progression disease or intolerant side effects
16154011|NCT01749072|Drug|Vinorelbine, Ifosfamide, Mesna|Vinorelbine 25mg/m2 d1,d8; Ifosfamide 1.25g/m1 d1-d3 (Usually 2g d1-d3); Mesna 400mg 0,4,8 hours after Ifosfamide administration for uroprotection d1-d3;
16154012|NCT01749046|Drug|Remegal|Remegal 1500 mg for 12 weeks
16154013|NCT01749033|Other|Group 1 Classic|"Active Comparator: Group 1 classic
~Group 1 Using the classic inserting technique and completely deflated LMA recommended in the LMA manual."
16154014|NCT01749033|Other|Group 2 pre-inflated|Group 2 (pre-inflated): Using the recommended inserting technique with the pre-inflated volume that exists in a LMA (Laryngeal Mask Airway) from the manufacturer.
16154015|NCT01749033|Other|Group 3 ELL-PIC|Group 3 (ELL-PIC): Using the ELL-PIC technique
16154016|NCT01749020|Other|Polyphenol-rich Dark chocolate|Participants will be asked to consume 20g of dark chocolate containing 500mg of polyphenols daily for a period of 4 weeks
16154017|NCT01749020|Other|Placebo Dark chocolate|Participants will be asked to consume 20g of dark chocolate containing little or no polyphenols for a period of 4 weeks
16154018|NCT01748994|Drug|Pioglitazone|30mg per day for four months
16154019|NCT01748994|Drug|Placebo|
16154020|NCT01748981|Other|Physical training|"Physical training three times a week for 20 week including endurance and strength training compare to the as usual group as controls"
16154021|NCT01748981|Other|As usual|Controls, not training
16154022|NCT01748955|Drug|Paroxetine CR for Major Depressive Episode|Dosage will be 25mg every day for 2 weeks, then 37.5mg every day for 2 weeks, and then optional increase to 50mg every day for the remainder of treatment.
16154023|NCT01748955|Drug|Bupropion XL for Major Depressive Episode|Dosage will be 150mg every day for 2 weeks, then 300mg every day for 2 weeks, and then optional increase to 450mg every day for the remainder of treatment.
16154024|NCT01748942|Drug|Dexamethasone|Given IV
16154025|NCT01748942|Drug|Dexamethasone|Given PO
16154026|NCT01748942|Other|Placebo|Given PO
16154027|NCT01748942|Procedure|Quality-of-Life Assessment|Ancillary studies
16154028|NCT01748942|Other|Questionnaire Administration|Ancillary studies
16154029|NCT01748942|Procedure|Transoral Robotic Surgery|Undergo TORS
16154030|NCT01748929|Drug|Albendazole|
16154031|NCT01748929|Drug|Placebo|
16154032|NCT01748916|Other|Papaya|Post-prandial study feeding 400-506 g papaya (1.6 mg beta-carotene, 2.1 mg beta-cryptoxanthin, 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.
16154033|NCT01748916|Other|Carrot|Post-prandial study feeding 25-35 g carrot (= 1.6 mg beta-carotene), 150 g yogurt (10% fat), and 45 g of fat free bread.
16154034|NCT01748916|Other|Tomato|Post-prandial study feeding 256-396 g tomato (= 13 mg lycopene), 150 g yogurt (10% fat), and 45 g of fat free bread.
16154035|NCT01748903|Device|Target 360°, 2D Coils, Nano Coils|
16154036|NCT01748890|Device|Sonoelastography|Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.
16154136|NCT01748227|Behavioral|Peer-Delivered Pain Self-Management|Patients (n=20) were assigned a peer coach to meet with for 4 months to discuss pain self-management.
16154037|NCT01748877|Drug|NXN-462|Study drug is to be self-administered twice each day by the patient. Each day the first dose of study drug should be taken preferably one hour prior to, OR one hour after the first meal (breakfast) of the day. The second and final dose each day should be taken with a glass of water at least one hour after the last meal immediately before retiring to sleep.
16154038|NCT01748877|Drug|Placebo|Study drug is to be self-administered twice each day by the patient. Each day the first dose of study drug should be taken preferably one hour prior to, OR one hour after the first meal (breakfast) of the day. The second and final dose each day should be taken with a glass of water at least one hour after the last meal immediately before retiring to sleep.
16154039|NCT01748864|Drug|Etarfolatide (EC20)|
16154040|NCT01748851|Drug|XELOX|capecitabine 1000mg/m2 bid po D1-D14
16154041|NCT01748851|Drug|FOLFOX|5-FU 400mg/m2 iv push D1, 5-FU 1200mg/m2 over 22hr D1,D2
16154042|NCT01748838|Drug|CTX-4430|Ascending single oral doses of CTX-4430 will be administered to subjects in 6 cohorts on day 1. Following a 14-day washout, subjects in two of the six cohorts will cross-over, fed a high fat diet and administered different single oral doses of CTX-4430
16154043|NCT01748838|Other|Mannitol|excipient blended with CTX-4430 in capsules
16154044|NCT01748838|Drug|Placebo|Single oral doses of placebo will be administered to subjects in 6 cohorts on day 1. Following a 14-day washout, subjects in two of the six cohorts will cross over, fed a high fat diet and administered single oral doses of placebo
16154045|NCT01748838|Drug|CTX-4430|Ascending repeat doses of CTX-4430 will be administered orally, once-daily, to subjects in 4 cohorts on days 1-14.
16154046|NCT01748838|Drug|Placebo|Repeat doses of placebo will be administered orally, once-daily, to subjects in 4 cohorts on days 1-14.
16154047|NCT01748838|Other|Mannitol|excipient blended with CTX-4430
16154048|NCT01748825|Drug|MK-1775 (AZD1775)|MK-1775 (AZD1775) is an inhibitor of Wee1-kinase.In preclinical models, MK-1775 selectively enhanced chemotherapy-induced death of cells deficient in tumor protein p53 (p53) signaling.
16154049|NCT01748812|Drug|Osteomalacia|
16154050|NCT01748799|Drug|Sativex|All participants received the same interventions (Fixed or Self-Titrated Sativex), just in different sequences.
16154051|NCT01748799|Drug|Placebo|All participants received the same interventions (Fixed or Self-Titrated Placebo), just in different sequences.
16154052|NCT01748786|Behavioral|Mindfulness Emotion Regulation|12 on-line modules provide didactic information and practice instructions re: mindfulness meditation for pain and distress
16154053|NCT01748786|Other|Health Education|12 on-line modules that provide information regarding health behaviors, but no information regarding how to put behaviors into practice
16154054|NCT01748773|Drug|Oxaliplatin|Participants will receive oxaliplatin 100 mg/m^2 IV on Day 1 of Cycles 1-3.
16154055|NCT01748773|Radiation|Radiation|Participants will receive radiotherapy at total dose of 45 Gy divided into 25 doses, 5 treatments per week for 5 weeks starting on Day 1 of Cycle 4.
16154056|NCT01748773|Drug|Capecitabine|Participants will receive capecitabine 850 mg/m^2 orally twice daily on Days 1-14 of Cycles 1-3 and on 5 days per week during chemoradiotherapy.
16154057|NCT01748773|Drug|Trastuzumab|Participants will receive trastuzumab 8 mg/kg IV on Day 1 Cycle 1, 6 mg/kg IV on Day 1 of each following 3-week cycle for 12 months (a total of 17 doses).
16154058|NCT01748760|Behavioral|CLASP-A intervention|Three individual sessions with adolescent patient using acceptance based strategies and motivational interviewing techniques. Sessions focused on identifying personalized risk factors for suicidal behavior, identifying values and goals, and development of personalized safety plan.
16154059|NCT01748760|Other|Treatment as Usual|Referral to outpatient treatment as part of routine discharge planning.
16154060|NCT01748747|Drug|Montanide ISA 51 VG|Given SC
16154061|NCT01748747|Biological|MART-1 antigen|Given SC
16154062|NCT01748747|Other|laboratory biomarker analysis|Correlative studies
16154063|NCT01748747|Biological|Gag:267-274 peptide vaccine|Given SC
16154064|NCT01748747|Drug|resiquimod|Applied topically
16154065|NCT01748734|Procedure|quality-of-life assessment|Ancillary studies
16154066|NCT01748734|Other|questionnaire administration|Ancillary studies
16154067|NCT01748734|Other|counseling intervention|Undergo cognitive behavioral therapy
16154068|NCT01748734|Behavioral|behavioral intervention|Undergo cognitive behavioral therapy
16154069|NCT01748721|Biological|anti-endosialin/TEM1 monoclonal antibody MORAb-004|Given IV
16154070|NCT01748721|Other|pharmacological study|Correlative studies
16154071|NCT01748721|Other|laboratory biomarker analysis|Optional correlative studies
16154072|NCT01748708|Device|Magnetic seizure therapy|100% machine output at 100 Hz, with coil directed over frontal brain regions, until adequate seizure achieved. Treatments will be administered 3 times per week, up to a maximum of 15 treatments. If subjects fail to achieve the pre-defined criteria of remission at that point, they will be considered non-remitters and will exit the study.
16154073|NCT01748708|Device|Electroconvulsive therapy|ECT treatments will be administered 3 times per week using the MECTA spECTrum 5000Q. Subjects will be treated with an ultrabrief (0.3ms) pulse with a bilateral placement at 6 times the seizure threshold, up to a maximum of 15 treatments. If subjects fail to achieve the pre-defined criteria of remission at that point, they will be considered non-remitters and will exit the study.
16154074|NCT01748695|Drug|V158866|
16154075|NCT01748695|Drug|Placebo|
16154076|NCT01748682|Other|A very low calorie diet of two different consistencies|Liquid and normal consistency diet with a very low calorie diet will be given to patients pre-operatively in bariatric surgery
16154077|NCT01748669|Dietary Supplement|Garlic oil|Oral administration
16154078|NCT01748656|Device|IVAPS|IVAPS mode (RESMED Stelar 150) during 1 night
16154079|NCT01748656|Device|AVAPS|AVAPS mode (PHILIPS-RESPIRONICS-A30) during 1 night
16154080|NCT01748643|Drug|deep neuromuscular blockade with rocuronium, reversal with sugammadex|after induction of anesthesia, a rocuronium infusion (0.6mg/kg (lean body mass)/h,) is started and titrated to a post tetanic count of 1-2 twitches. At the end of surgery neuromuscular blockade will be reversed with sugammadex 4mg/kg. Patients are extubated when TOF ratio > 0.9.
16154176|NCT01747915|Drug|Placebo|Placebo, either liquid or capsule, dosed twice daily beginning at Randomization to End of Study/Early Termination.
16154313|NCT01746849|Procedure|peripheral blood stem cell transplantation|
16154081|NCT01748643|Drug|normal neuromuscular blockade reversal with rocuronium, reversal with neostigmine|After induction of anesthesia, top-ups of rocuronium (10mg) are given as needed to maintain a train of four count of 1-2. At the end of surgery neuromuscular blockade will be reversed with neostigmine 50μg/kg and glycopyrrolate 10μg/kg (lean body mass). Patients are extubated when the train of four ratio is > 0.9.
16154082|NCT01748630|Drug|dexmedetomidine|
16154083|NCT01748630|Drug|Midazolam|
16154084|NCT01748630|Drug|fentanyl|
16154085|NCT01748617|Other|Controlled diet|1 week of controlled diet
16154086|NCT01748604|Other|Manual Lymphatic Drainage (MLD)|MLD with Földi's technique by an expert therapist during 45 minutes
16154087|NCT01748604|Device|Generic intermittent pneumatic compression Device (IPC)|Generic intermittent pneumatic compression with multicompartmental pump between 50 to 80 mmHg during 30 minutes.
16154088|NCT01748604|Other|multilayer, multicomponent bandages (MB)|multilayer, multicomponent bandages (MB) until next day.
16154089|NCT01748604|Device|Lymphapress-Plus(TM) device (LPD)|Pneumatic massage with Lymphapress-Plus(TM)device that was lent during the duration of the study during 20 minutes.
16154090|NCT01748578|Drug|EBI-005-1|EBI-005-1 is an intervention to two different study arms: 5mg/ml Vs Placebo and 20 mg/ml Vs Placebo
16154091|NCT01748578|Drug|EBI-005-1 Placebo|
16154092|NCT01748552|Drug|Placebo|Administered orally as capsules
16154093|NCT01748552|Drug|LY2922083|Administered orally as capsules
16154094|NCT01748539|Drug|KHK4827|
16154095|NCT01748539|Drug|Placebo|
16154096|NCT01748526|Drug|Canagliflozin (JNJ-28431754) 200 mg|One 200 mg tablet taken orally (by mouth) on Day 1.
16154097|NCT01748526|Drug|Canagliflozin (JNJ-28431754) 300 mg|One 300 mg tablet taken orally (by mouth) on Day 1.
16154098|NCT01748513|Other|preoperative venous return optimizing|Preoperative transthoracic echocardiography (TTE) was performed in the awake state before and after volume challenge based on 6ml colloids /kg ideal body weight.
16154099|NCT01748500|Drug|Pantoprazole|
16154100|NCT01748487|Drug|dexamethasone intravitreal implant (OZURDEX)|intravitreal implant
16154101|NCT01748474|Procedure|Supplemental oxygen via a mask|
16154102|NCT01748461|Behavioral|Structured intervention|3x/week - 10 weeks - Support by fitness instructor - Individualised exercise program (cycle ergometer)
16154103|NCT01748461|Behavioral|Coach intervention|promote autonomy - 4 visits during 10 weeks - Support by coach (encouragement) - Individualised exercise program
16154104|NCT01748448|Drug|Vitamin D|"prospective interventional randomized double blind placebo controlled trail
~clinical setting (tertiary university hospital)
~investigator driven, no pharmaceutical sponsor
~cutaneous malignant melanoma patients
~add- on study (placebo or vitamin D) on top of optimal standard care
~1:1 inclusion ratio (placebo:Vitamin D)
~randomisation after informed consent and screening"
16154105|NCT01748448|Drug|arachides oleum raffinatum|
16154106|NCT01748435|Drug|Qutenza|Single treatment with Qutenza
16154107|NCT01748422|Drug|Qutenza|Transdermal patch
16154108|NCT01748409|Other|Biopsies of peripheral autonomic nervous system|
16154109|NCT01748409|Other|Autonomic dysfunction questionnaires|
16154110|NCT01748409|Other|Electrophysiological tests|
16154111|NCT01748396|Drug|Calcitriol|
16154112|NCT01748396|Drug|Calcium Carbonate|
16154113|NCT01748383|Procedure|Transplantation of BMMCs|The wing of the ilium was punctured under the local anesthesia for receiving of autologous BMCs. 100 ml of bone marrow aspirate was taken. BMMCs were obtained by the method of the gradient centrifugation. Autologous BMMCs in the number 93±43 million transplantation by balloon catheter performed into IRA at once after stent implantation.
16154114|NCT01748383|Procedure|Transplantation of CD 133+ cells|The wing of the ilium was punctured under the local anesthesia for receiving of autologous BMCs. 100 ml of bone marrow aspirate was taken. Autologous CD133 + cells were obtained by the method of the magnetic separation. Phenotyping of the transplanted cells was performed by the cytofluorimetry. Autologous CD 133+ BMCs in the number 5,7 (0,45;9,0) million transplantation by balloon catheter performed into IRA at once after stent implantation.
16154115|NCT01748383|Procedure|stenting of IRA|The only stent implantation
16154116|NCT01748370|Drug|Vitamin D supplementation in hypogonadal men|
16154117|NCT01748370|Drug|Vitamin D supplementation in eugonadal men|
16154118|NCT01748370|Drug|Placebo hypogonadal|
16154119|NCT01748370|Drug|Placebo eugonadal|
16154120|NCT01748344|Drug|Cetirizine|10mg tablets
16154121|NCT01748344|Drug|High dose ONO-4053|Experimental
16154122|NCT01748344|Drug|Low dose ONO-4053|Experimental
16154123|NCT01748344|Drug|Placebo|None active
16154124|NCT01748331|Other|Fluid restriction|Patients will be randomized to strict fluid restriction < 1 L/day versus moderate fluid restriction < 2.5 L/day
16154125|NCT01748318|Drug|New Mexico Honey|Apply 15 ml of NM Honey to CA-MRSA Abscess compare to standard antibiotic treatment
16154126|NCT01748318|Drug|Bactrim DS|Bactrim DS
16154127|NCT01748305|Behavioral|Moderate-to-vigorous intensity exercise|Moderate-to-vigorous intensity exercise three times per day for three weeks
16154128|NCT01748292|Drug|0.5 mg ranibizumab|Subject will receive drug (ranibizumab) via intravitreal injections (IVT) at every visit.
16154129|NCT01748279|Drug|Atorvastatin|
16154130|NCT01748279|Drug|Formoterol|12mcg of Foradil BID as maintenance COPD treatment in both treatment arms
16154131|NCT01748279|Drug|Lactose tablet|One lactose tablet taken once a day as add-on treatment to Formoterol therapy
16154132|NCT01748266|Other|microcirculatory reactivity|Microcirculation of the thenar eminence was analyzed by NIRS technology, through the StO2 and the resaturation slope after an ischemic challenge.
16154133|NCT01748253|Drug|Telmisartan-amlodipine tablet administration group (morning)|Oral-administration of one telmisartan-amlodipine tablet once a day upon morning for 12 weeks
16154134|NCT01748253|Drug|Telmisartan-amlodipine tablet administration group (bedtime)|Oral-administration of one telmisartan-amlodipine tablet once a day at bedtime for 12 weeks
16154135|NCT01748240|Drug|Azacitidine and oral vorinostat|In patients still responding after six cycles, the drugs will continue to be supplied, and follow up until death or unacceptable tolerance will be continued in all patients.
16154274|NCT01747083|Drug|FDC(gemigliptin/metformin HCl sustained release 50/1000mg(25/500mg x 2tablets))|
16154137|NCT01748201|Procedure|Joint lavage and viscosupplementation|The joint will be washed until obtaining translucent liquid and not hemorrhagic. Then it will receive an intra-articular injection of 6ml of hyaluronic acid (Synvisc One), 1ml of triamcinolone and 2 ml of ropivacaine.
16154138|NCT01748188|Procedure|Ultrasound|Ultrasound of 1 MHz, intensity 2 W/cm2, 5 minutes, for 20 sessions.
16154139|NCT01748188|Procedure|Phonophoresis|Phonophoresis with 50 mg dexketoprofen (Enangel), 1 MHz, intensity 2 W/cm2, 5 minutes, for 20 sessions.
16154140|NCT01748188|Procedure|Iontophoresis|Iontophoresis by galvanic direct current with 50 mg dexketoprofen (Enantyum), intensity 2 mA, 20 minutes, for 20 sessions.
16154141|NCT01748188|Procedure|Exercises|Guideline of 7 standardized exercises to improve the muscular force and to open the subacromial space.
16154142|NCT01748188|Procedure|Cryotherapy|Cooling located by a cold air bundle to -32 Celsius degrees (ºC) for 3 minutes.
16154143|NCT01748175|Drug|Triamcinolone Acetonide|Each subject that meets inclusion/exclusion criteria will receive triamcinolone acetonide intramuscularly at the end of visit 2. Adults ≥18 years will receive 40 mg triamcinolone acetonide. Children 6-17 years will receive 1 mg/kg triamcinolone acetonide (up to 40 mg maximum). Triamcinolone acetonide will be administered as a single intramuscular dose deep in the gluteal region
16154144|NCT01748162|Drug|Fluticasone|Daily inhaled steroids. Fluticasone 2 puffs inhaled orally twice daily for six months.
16154145|NCT01748162|Drug|Prednisolone IF needed|
16154146|NCT01748149|Drug|Vemurafenib|"Vemurafenib is supplied in 120-mg and 240-mg film-coated tablets packed in bottles for oral administration. Dosing is based on the body surface area (BSA) calculated at the beginning of each course of therapy. The dose prescribed should be rounded to the nearest deliverable dose based on the BSA adjustment and the available pill sizes. Dosing will not exceed the adult MTD of 960 mg twice a day (BID). Patients will be provided with a Medication Diary for vemurafenib, instructed in its use, and asked to bring the diary with them to each appointment.
~Treatment will be administered on an outpatient basis. Dosing is based on the BSA calculated at the beginning of each course of therapy. The dose prescribed should be rounded to the nearest deliverable dose based on the BSA adjustment and the available pill sizes. Regardless of cohort, patients will self-administer vemurafenib BID at the assigned dose level. Patients will be instructed to hold their dose of vemurafenib for PK or surgery."
16154147|NCT01748136|Device|CT Scan with Spirometry|During the screening and later during the five annual study visits the patients will be scheduled to undergo total of five CT scans. The first CT scan will take place at the beginning of the study and then each year for a period of five years.
16154148|NCT01748123|Drug|Chlorthalidone|Initial dose of 12.5mg daily Chlorthalidone (force titrated to 25mg at 4 weeks)
16154149|NCT01748123|Drug|Hydrochlorothiazide|Initial dose 25mg daily HCTZ (force titrated to 50mg at 4 weeks)
16154150|NCT01748110|Behavioral|Intensive Fitness Intervention|This intervention will involve adhering to health interventions such as behavior and diet modification, and exercise. Patients will follow-up monthly with a health counselor to verify progress.
16154151|NCT01748110|Behavioral|TRIMM|text message intervention.
16154152|NCT01748097|Drug|sodium bicarbonate 4.2%|
16154153|NCT01748084|Drug|Rituximab|Days 1 and 15, rituximab 1 gramme plus 100 mg methylprednisolone
16154154|NCT01748084|Drug|Placebo (NaCl)|Days 1 and 15, NaCl 500 ml plus 100 mg methylprednisolone
16154155|NCT01748058|Behavioral|Exercise based on active video gaming|
16154156|NCT01748045|Drug|inhaled nitric oxide|
16154157|NCT01748045|Drug|Placebo Comparator - nitrogen gas|
16154158|NCT01748032|Behavioral|Cognitive training|20 minutes/day for 5 sequential working days
16154159|NCT01748019|Drug|ST1968|ST1968 once a week for 2 weeks every 3 weeks (protocol amendment: once every 3 weeks
16154160|NCT01748006|Other|Standard of care therapy for severe decompensated heart failure|
16154161|NCT01747993|Drug|Tamsulosin (0.4 mg/j)|(1 tablet / day for 6 days)
16154162|NCT01747993|Drug|Placebo|(1 tablet / day for 6 days)
16154163|NCT01747980|Drug|PRX-112|Single dose level, four doses per cohort
16154164|NCT01747967|Other|Meal Test|Insulin secretion is stimulated by a standardized meal test. Blood and urine samples are collected in order to measure serum and urinary C peptide, glucagon and T-lymphocyte responses against selected beta-cell antigens. The meal test is performed at 0, 6, 12, 18, 24 and 30 months.
16154165|NCT01747954|Other|Bag Squeezing|To perform the BS technique, we used a Protec® manual inflation bag with a flow of 10 L / min and 100% oxygen. A Commercial Medical® manometer was adapted between the orotracheal tube and the inflation bag to monitor the inflation pressure which was recommendedat 30 cmH2O for all children of the BS group. Initially we instilled at most 0.5 ml saline solution(SS) at 0.9% followed by 10 manual hyperinflation maneuvers interspersed with 10 vibrocompression maneuvers and as a last procedure, we performed an aspiration of the orotracheal tube airways and mouth. Between the aspirations the child was re-connected to the ventilator.
16154166|NCT01747954|Other|Thoracic vibrocompression|To perform the TVC technique, we applied 10 vibrocompression maneuvers on the chest of the children during the expiratory phase of the respiratory cycle, on each of the lateral decubitus position, totaling 20 maneuvers, followed by aspiration in the dorsal decubitus position. All measurements in both study groups were performed with the child connected to the ventilator. Before starting the maneuver BS or TVC the child received an increase of 20% fraction of inspired oxygen (FiO2) from what was received previously in MV and after data collection FiO2 returned to baseline values.
16154167|NCT01747941|Drug|PF-06305591|single dose, solution
16154168|NCT01747941|Drug|Placebo|matching placebo
16154169|NCT01747941|Drug|PF-06305591|single dose, solution
16154170|NCT01747941|Drug|Placebo|matching placebo
16154171|NCT01747941|Drug|PF-06305591|single dose, solution
16154172|NCT01747941|Drug|Placebo|matching placebo
16154173|NCT01747928|Other|dual-chamber syringe|dual-chamber syringe for mock injection
16154174|NCT01747915|Drug|Pregabalin Dose Level 1|Pregabalin, either liquid or capsule, dosed twice daily, escalated up to a maximum of 300 mg/day beginning at Randomization to Taper Phase, then tapered down to a maximum dose of 150 mg/day during 1 week Taper Phase to End of Study/Early Termination.
16154175|NCT01747915|Drug|Pregabalin Dose Level 2|Pregabalin, either liquid or capsule, dosed twice daily, escalated up to a maximum of 600 mg/day beginning at Randomization to Taper Phase, then tapered down to a maximum of 150 mg/day during 1 week Taper Phase to End of Study/Early Termination.
16154177|NCT01747902|Procedure|Biceps Tenotomy|The biceps tenotomy group will have their bicep treated by detaching the tendon from the shoulder.
16154178|NCT01747902|Procedure|Biceps Tenodesis|The biceps tenodesis group will have their bicep detached and then re-inserted onto the shoulder.
16154179|NCT01747889|Device|electronic chest drainage system|"Patients in the intervention arm are connected to Thopaz, electronic drainage system immediately after closure of the chest, patients in the control group are connected to a traditional system. Chest tubes in both groups are then connected to suction of -20 cmH2O and maintained at that level until post-operative day #1.
~On the morning of post-operative day #1, presence of air leak will be recorded on suction. Then, suction will be decreased to -8 cmH2O (so-called water seal). At that time, management of chest tube drainage and decision for chest tube removal will be dictated by clinical signs, symptoms, and surgeon preference following the standard clinical algorithm for post-operative care of general thoracic patients"
16154180|NCT01747876|Drug|LEE011|LEE011 is a small molecule inhibitor of CDK4/6.
16154181|NCT01747863|Other|Neurologic examination|Neurologic examination includes: (1) neurologic examination using modify Sarnat score at </= 6 hrs of age, 24 hrs and at discharge home, (2) aEEG at 6 ± 3 hrs of age, (3) Brain MRI before discharge home to 30 days of age.
16154182|NCT01747850|Behavioral|Motivational Enhancement/Cognitive Behavioral Therapy|All participants will receive a combination of pharmacotherapy (Sativex or Placebo) associated with a weekly intervention of combined Motivational Enhancement Therapy and Cognitive Behavioral Therapy.
16154183|NCT01747850|Drug|Sativex|Study subjects will gradually increase the maximal allowed dose of Sativex starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The target quit date will be set at Day 21 (but subjects will be allowed to stop using cannabis before if they are willing and able to). The medication treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Spray that will be decreased by 50% to avoid abrupt withdrawal). Then exposure to medications will be stopped (so there will be a total of 12 weeks medication treatment exposure).
16154184|NCT01747850|Drug|Placebo spray|Study subjects will gradually increase the maximal allowed dose of Placebo starting at five sprays per day for the first two days and increasing of five sprays per day until reaching the max number of 42 sprays maximal per day at end of week 2 (Day 11). The target quit date will be set at Day 21 (but subjects will be allowed to stop using cannabis before if they are willing and able to). The Placebo treatment phase will then be continued for an additional 9 weeks (the last week will be a reduction phase with the use of Placebo Spray that will be decreased by 50%). Then exposure to Placebo will be stopped (so there will be a total of 12 weeks Placebo treatment exposure).
16154185|NCT01747837|Device|Boston Scientific Vessix Renal Denervation System|"Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.
~Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts"
16154186|NCT01747811|Device|wavelength-1 bright light|6 weeks of daily light exposure, 30 minutes per morning
16154187|NCT01747811|Device|wavelength-2 bright light|6 weeks of daily light exposure, 30 minutes per morning
16154188|NCT01747798|Drug|auranofin|Given PO
16154189|NCT01747798|Other|laboratory biomarker analysis|Correlative studies
16154190|NCT01747785|Other|Cardiac rehabilitation|Aerobic cardiac exercise training will be provided over the 12 week study duration.
16154191|NCT01747785|Other|Myocardial deformation imaging|A 2D Doppler echocardiograph (image) of the heart will be captured during a single heart beat taken at rest and during cardiopulmonary exercise tests to measure left and right ventricular segmental systolic and diastolic strain measurements.
16154192|NCT01747785|Other|Cardiopulmonary exercise test|The cardiopulmonary exercise test consists of cycling exercise of mild and moderate intensity on an upright cycle ergometer on a tilting table (to facilitate imaging) for 6-10 minute periods within a one hour session.
16154193|NCT01747772|Device|Shear Wave Sonoelastography|Shear Wave sonoelastography (SWE) as an ultrasound technique to measure liver fibrosis was performed on patients scheduled for non-focal liver biopsy. Results were compared with pathological score from liver biopsy.
16154194|NCT01747759|Other|Kruskal-Wallis and qualitative parameters|
16154195|NCT01747746|Drug|Rivaroxaban|Rivaroxaban versus Historical controlled Anticoagulation with Warfarin and Enoxaparin
16154196|NCT01747746|Drug|Warfarin and Enoxaparin|Historical Control
16154197|NCT01747733|Device|Bispectral Index|use of BiS-monitor in the assessment of the level of sedation in patients receiving sedation in endoscopy procedures when compared to clinical sedation scales, such as the Richmond agitation-sedation score.
16154198|NCT01747720|Dietary Supplement|Vitamin D3|Given orally
16154199|NCT01747720|Dietary Supplement|Placebo|
16154200|NCT01747707|Drug|Docetaxel|
16154201|NCT01747707|Drug|Cisplatin|
16154202|NCT01747707|Drug|S-1|
16154203|NCT01747694|Behavioral|Multi-respiratory muscle training|Patients will be taught the diaphragmatic breathing technique at the same time also will be instructed a four-item (including upper-arm weighted exercise, body side-bends, modified sit-ups, body crunching) multi-respiratory muscle training motions. To practice three times/day, three days a week lasting 12 weeks at home.
16154204|NCT01747681|Procedure|Microfracture|
16154205|NCT01747668|Dietary Supplement|Similac Prenatal Vitamin soft-gel capsule|One capsule per day for Experimental Supplement A Group; Two capsules per day for Experimental Supplement B Group
16154206|NCT01747668|Dietary Supplement|Placebo (soybean oil and dl-alpha-tocopheryl acetate)|Two capsules per day for the Placebo Group; One capsule per day for the Experimental Group A
16154207|NCT01747642|Dietary Supplement|Oncoxin|Syp Oncoxin 25 ml bd and Cap. Oncoxin bd for 180 days
16154208|NCT01747642|Drug|Suranix|Tab Suranix 200 mg 2 tab bd and Syp Oncoxin 25 ml bd and Cap. Oncoxin bd for 180 days
16154209|NCT01747629|Drug|Placebo MDPI|Placebo MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.
16154210|NCT01747629|Drug|Albuterol MDPI|Albuterol MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.
16154211|NCT01747616|Device|Chitosan-N-acetylcysteine eye drops (concentration of 0.1%)|1 drop of the medical device in 1 randomly chosen eye
16154212|NCT01747616|Other|Physiological saline solution|1 drop as placebo in the other eye not receiving the medical device
16154213|NCT01747603|Other|Specialized LPTB clinic|50% of enrolled infants will be randomized to the specialized LPTB follow-up clinic.
16154214|NCT01747590|Drug|Zolpidem|
16154215|NCT01747590|Drug|Alprazolam|
16154216|NCT01747590|Drug|Caffeine|
16154217|NCT01747590|Other|Placebo|
16154218|NCT01747577|Drug|Solifenacin Succinate|Oral
16154219|NCT01747577|Drug|Placebo|Oral
16154220|NCT01747564|Drug|YM178 (mirabegron)|oral
16154221|NCT01747551|Drug|Oxaliplatin|
16154222|NCT01747551|Drug|Leucovorin|
16154223|NCT01747551|Drug|Fluorouracil|
16154224|NCT01747551|Drug|Ziv-aflibercept|
16154225|NCT01747538|Drug|Placebo|Solution for subcutaneous injection
16154226|NCT01747538|Drug|Dose 1 gevokizumab|Solution for subcutaneous injection
16154227|NCT01747538|Drug|Dose 2 gevokizumab|Solution for subcutaneous injection
16154228|NCT01747525|Device|NIRS/IVUS of coronary artery|Evaluation of coronary plaque by NIRS/IVUS.
16154229|NCT01747512|Drug|C-PERT|Patients with thyroid and Head and Neck cancer
16154230|NCT01747512|Drug|G-PERT|Patients with thyroid and Head and Neck cancer
16154231|NCT01747499|Drug|Azacitidine|
16154232|NCT01747486|Biological|CART-19|CART-19 cells (autologous T cells expressing CD19 chimeric antigen receptors expressing tandem TCR zeta and 4-1BB costimulatory domains)
16154233|NCT01747447|Dietary Supplement|Vitamin D3 placebo|Vitamin D placebo
16154234|NCT01747447|Dietary Supplement|Fish oil placebo|Fish oil placebo
16154235|NCT01747447|Drug|omega-3 fatty acids (fish oil)|Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
16154236|NCT01747447|Dietary Supplement|Vitamin D3|Vitamin D3 (cholecalciferol), 2000 IU per day.
16154237|NCT01747408|Drug|Human Albumin|"25% human albumin given in four escalating doses:
~Group 1: .625g/kg infused over 3hrs daily X 7day
~Group 2: 1.25g/kg infused over 3hrs daily X 7day
~Group 3: 1.875g/kg infused over 3hrs daily X 7day
~Group 4: 2.5g/kg infused over 3hrs daily X 7day"
16154238|NCT01747395|Other|Exercise training|The heart failure patients are subjected to differents protocols of physical training
16154239|NCT01747382|Procedure|Renal denervation|
16154240|NCT01747356|Device|Resolute stent treatment|A well known coronary stent system that is produced by Medtronic Company and is also recommended by FDA for treating diabetic coronary lesion.
16154241|NCT01747343|Behavioral|Underwear/Differential Reinforcement|Participants are going to be placed in underwear. Differential reinforcement will then be implemented.
16154242|NCT01747330|Drug|Pancreatin|Doses of Pancreatin <2500 lipase u/kg/feed or <4000 lipase U/g fat/intake or <10000 lipase U/kg/day given orally are used
16154243|NCT01747317|Device|FFR (PressureWire)|Fractional flow reserve measured during cardiac catheterization--A pressure-monitoring guidewire(PressureWire Certus, St. Jude Medical Systems, Uppsala, Sweden;ComboWire, Volcano Corporation, San Diego, California) will be advanced past the stenosis.
16154244|NCT01747304|Device|DXA Se femur scans (previously called IVA femur)|Single Energy Beam (previously called inter-vertebral assessment) by Dual energy x-ray absorptiometry of affected femur
16154245|NCT01747278|Drug|Trimethoprim/Sulfamethoxazole|Oral Trimethoprim/Sulfamethoxazole 80 mg/400mg once daily for 12 weeks.
16154246|NCT01747252|Dietary Supplement|RGC|
16154247|NCT01747252|Dietary Supplement|RGC|
16154248|NCT01747252|Dietary Supplement|Resveratrol|The equivalent of 150 mg resveratrol
16154249|NCT01747239|Drug|Cabazitaxel|25 mg/m2 IV every three weeks
16154250|NCT01747226|Other|Fluoride rinse|rinse with 15 ml for 1 minute
16154251|NCT01747226|Other|Halita|rinsing with 15 ml for 1 minute
16154252|NCT01747226|Other|Meridol Halitosis|rinsing with 15 ml for 1 minute
16154253|NCT01747226|Other|Water|rinsing with 15ml for 1 minute
16154254|NCT01747213|Drug|BNC|
16154255|NCT01747213|Other|Placebo|Microcrystalline cellulose fiber
16154256|NCT01747200|Procedure|Sham rTMS|
16154257|NCT01747200|Procedure|Bilateral rTMS at same frequency and in phase|
16154258|NCT01747200|Procedure|Bilateral rTMS at different frequencies|
16154259|NCT01747200|Procedure|Bilateral rTMSat same frequency and out of phase|
16154260|NCT01747200|Procedure|rTMS over TP8|
16154261|NCT01747200|Procedure|rTMS over TP7|
16154262|NCT01747174|Drug|IC Adenosine|IC Adenosine 1mg injected distally via micro-catheter in to IRA following thrombus aspiration with further dose (1mg if IRA is RCA otherwise 2mg) via guide catheter following coronary stent deployment.
16154263|NCT01747174|Drug|IC Sodium nitroprusside (SNP)|IC SNP 250mcg injected distally via micro-catheter distally in to IRA following thrombus aspiration with further 250 mcg dose delivered via guide catheter following coronary stent deployment.
16154264|NCT01747174|Procedure|Standard PCI|PCI procedure with thrombectomy (via aspiration catheter) and bivalirudin given as standard.
16154265|NCT01747161|Drug|Botulin toxin|50 I.E. Botulin toxin. Injections in 6 spots of the vestibulum vaginae (3 sessions (every 6 weeks))
16154266|NCT01747161|Drug|physiological water|3 mL physiological water. Injections in 6 spots of the vestibulum vaginae (3 sessions (every 6 weeks))
16154267|NCT01747148|Drug|AVI-7100 versus placebo|dose-escalating AVI-7100 versus placebo
16154268|NCT01747135|Drug|VTS-270|
16154269|NCT01747122|Device|Wound catheter|Wound catheter, placed at end of procedure, prior to closure. To be kept in for 48 hours.
16154270|NCT01747122|Device|Epidural|
16154271|NCT01747109|Device|PREOXYFLOW|"Patients randomized in PREOXYFLOW group will received a four minutes preoxygenation period with Nasal High Flow Therapy (HFT) Optiflow ® (60 l/mn FIO2 = 1) before orotracheal intubation under laryngoscopy after crash induction"
16154272|NCT01747109|Procedure|STANDARD FACE MASK|"Patients randomized in STANDARD FACE MASK group will received a four minutes preoxygenation period with a standard face mask (15 l/mn) before orotracheal intubation under laryngoscopy after crash induction. Each hospital involved in this study will use the standard face mask as per its usual practice (no specific trademark requested by this protocol)"
16154273|NCT01747096|Drug|68-Ga-DOTANOC|
16154312|NCT01746849|Biological|Lupron|
16154275|NCT01747070|Other|tDCS and EAC sham|The tDCS apparatus is operated on battery power, will be used rubber electrodes soaked in saline solution. The anode is placed in M1 and the cathode in the supraorbital region.
16154276|NCT01747070|Other|tDCS sham and EAC sham|For the EAC sham we will use rubber electrodes. They will be applied in the same areas of active EAC. They are connected to the same electroacupuncture device, but without current passing for the patient. All subjects receive one 30min session.
16154277|NCT01747070|Other|tDCS sham and EAC|For the sham tDCS we will use the same apparatus in the same location, but the current is stopped after 30 seconds.
16154278|NCT01747070|Other|tDCS and EAC|For the acupuncture we will use needles with guide tubes that are 40 mm in length and 0.25 mm in diameter. The needling will be applied using an electro acupuncture device in the dermatomes, myotome, or sclerotome corresponding to the nerve roots involved in the knee (L1, L2, L3, L4, L5, S1, and S2). All patients received one 30min session using a frequency of 2 Hz.
16154279|NCT01747057|Behavioral|Dynamic-parameters-guided fluid management|"● In preload-responsive patients defined by the following dynamic parameters: Patients fully adapted to mechanical ventilation* and with sinus rhythm.
~PPV >12%. PPV: Pulse pressure variation PPV = (PPmax-PPmin)/ [(PPmax+PPmin)/2] x100 (during 5 respiratory cycles)
~SVV > 12% (15). SVV: Stroke volume variation
~A tidal volume (Vt) ≥ 7-10cc/kg in mechanically ventilated (in a controlled mode - control volume or control pressure) and well-adapted patients without any inspiratory effort should be guaranteed.
~Fluid loading must be performed with crystalloids (1omL/Kg) or colloids (5ml/Kg) every 30 minutes until PPV-SVV < 12%, while hypoperfusion signs are present. Continue resuscitation following Surviving Sepsis Campaign rules excluding more fluid administration (as described in the standard intervention once CVP>12).
~● Non-preload responsive patients (defined as PPV or SVV < 12%) will resume the same protocol as responders when fluid response parameters are negative."
16154280|NCT01747057|Behavioral|Standard-guided-fluid management|Fluid loading in patients with hypotension or elevated lactates until normalization of MAP (> 65mmHg) or CVP > 12mmHg. If CVP reaches > 12 mmHg and MAP remains < 65mmHg, norepinephrine should be started to reach MAP > 65mmHg. Once MAP is restored, if hypoperfusion signs persist (elevated lactate or urine output < 0.5mL/Kg/h), ScvO2/SvO2 must be measured. In order to reach a ScvO2 ≥70% or SVO2 ≥65%, consider giving blood transfusion if hemoglobin level (Hb) ≤ 7g/dL, and also consider dobutamine (initial dose 2,5 µg/kg/min, increased by 2,5 µg/kg/min every 30 min up to a maximum dose of 20 µg/kg/min, presence of arrhythmia, or FC>110bpm). At that point, if hypoperfusion signs remain present, consider restart protocol from the beginning.
16154281|NCT01747044|Drug|Milnacipran|100mg/day
16154282|NCT01747044|Drug|Placebo|
16154283|NCT01747031|Device|PressureWire™ Certus(St. Jude Medical Systems, Sweden)|Fractional flow reserve measured during cardiac catheterization--A pressure-monitoring guidewire(PressureWire Certus, St. Jude Medical Systems, Uppsala, Sweden) will be advanced past the stenosis.
16154284|NCT01747018|Biological|Platelet-rich Plasma|
16154285|NCT01746992|Drug|Cyclophosphamide 750mg/m2|day 1 in both arms
16154286|NCT01746992|Drug|Vincristine 1.4mg/m2|day 1
16154287|NCT01746992|Drug|Doxorubicin 50mg/m2|day 1
16154288|NCT01746992|Drug|prednisone 60mg/m2|day1-day5
16154289|NCT01746992|Drug|ifosfamide 2000mg/m2|day 22-day 24
16154290|NCT01746992|Drug|pirarubicin 50mg/m2|day 1
16154291|NCT01746992|Drug|pirarubicin 25mg/m2|day 22
16154292|NCT01746992|Drug|Etoposide phosphate 100mg/m2|day 22-day 24
16154293|NCT01746992|Drug|methotrexate 1500mg/m2|day 43
16154294|NCT01746979|Drug|TH-302|TH-302 will be administered at a dose of 340 milligrams per square meter (mg/m^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
16154295|NCT01746979|Drug|Gemcitabine|Gemcitabine will be administered at a dose of 1000 (mg/m^2) as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
16154296|NCT01746979|Drug|Placebo (5 percent dextrose - D5W)|TH-302 placebo (5 percent dextrose - D5W) will be administered as intravenous infusion over 30 minutes on Day 1, 8 and 15 of every 28-day cycle. Doses will be administered until evidence of progressive disease, intolerable toxicity or subject withdrawal.
16154297|NCT01746940|Drug|Cocaine HCl 4% Topical Solution|Cocaine HCl 4% Topical Solution
16154298|NCT01746940|Drug|Cocaine HCl 10% Topical Solution|Cocaine HCl 10% Topical Solution
16154299|NCT01746940|Drug|Placebo Topical Solution|Placebo Topical Solution
16154300|NCT01746927|Other|Glidescope Cricoid pressure|The current study test by direct visual evidence the occlusion of esophageal entrance during application CP. The closure of the lumen was further demonstrated by the inability to introduce a GT into the esophagus during CP. using in radimized method : 0 N,10 N, 20N AND 30 N
16154301|NCT01746901|Drug|Placebo|Placebo solution + Placebo ALO-02 (intact)
16154302|NCT01746901|Drug|intact ALO-02 60 mg/7.2 mg|Placebo solution + ALO-02 60 mg/7.2 mg (intact)
16154303|NCT01746901|Drug|crushed ALO-02 60 mg/7.2 mg|crushed ALO-02 60 mg/7.2 mg in solution + placebo ALO-02 (intact)
16154304|NCT01746901|Drug|crushed oxycodone IR 60 mg|crushed oxycodone immediate-release (IR) 60 mg in solution + placebo ALO-02 (intact)
16154305|NCT01746901|Drug|crushed ALO-02 40 mg/4.8 mg|crushed ALO-02 40 mg/4.8 mg in solution + placebo ALO-02 (intact)
16154306|NCT01746901|Drug|crushed oxycodone IR 40 mg|crushed oxycodone immediate-release (IR) 40 mg in solution + placebo ALO-02 (intact)
16154307|NCT01746875|Drug|Aflibercept|2.0 mg monthly x 3 doses, then as needed based on recurrence of activity on OCT. If no effect after the initial 3 doses; 2.0 mg monthly x 3 doses is repeated.
16154308|NCT01746875|Drug|Verteporfin|given if aflibercept does not have any effect. Verteporfin photodynamic therapy is given in combination with aflibercept and triamcinolone. The treatment can be repeated after 3 month.
16154309|NCT01746862|Drug|Saizen®|Subjects in the Saizen test group will receive Saizen (recombinant-human growth hormone [r-hGH]) subcutaneously 6 days per week at a weight based dose of 0.067 milligram per kilogram of body weight per day (mg/kg/day) for 12 months.
16154310|NCT01746862|Drug|Saizen®|Subjects in the Saizen control group will receive no treatment for the first 6 months and thereafter will receive Saizen (r-hGH) subcutaneously 6 days per week at a weight based dose of 0.067 mg/kg/day for the next 6 months.
16154311|NCT01746849|Biological|Palifermin|
16154314|NCT01746849|Radiation|Total-Body Irradiation (TBI)|
16154315|NCT01746849|Drug|Thiotepa|
16154316|NCT01746849|Drug|Cyclophosphamide|
16154317|NCT01746849|Drug|Degarelix|
16154318|NCT01746836|Other|Laboratory Biomarker Analysis|Blood draws.
16154319|NCT01746836|Drug|Ponatinib Hydrochloride|Starting dose: 30 mg by mouth once a day.
16154320|NCT01746836|Other|Quality-of-Life Assessment|Surveys completed.
16154321|NCT01746823|Drug|Cyclosporins|
16154322|NCT01746810|Radiation|Stereotactic body RT and IRGA|SABR Treatment with Dose escalation: Group 1: 40 Gy/5 fractions Group 2: 45 Gy/5 fractions Group 3: 50 Gy/5 fractions then IRGA procedure 1 week later with repeat lung biopsies, serum studies
16154323|NCT01746784|Drug|N6022|Intravenous solution of N6022 in normal saline administered by infusion pump over 1-8 minutes depending on the dose
16154324|NCT01746784|Drug|Normal saline|Intravenous solution of 0.9% (weight/volume) NaCl administered by infusion pump over 1-8 minutes depending on dose of active drug used in same cohort
16154325|NCT01746771|Drug|HM781-36B(Poziotinib)|QD*2weeks/3weeks
16154326|NCT01746771|Drug|Paclitaxel|175mg/m2
16154327|NCT01746771|Drug|Trastuzumab|8mg/kg
16154328|NCT01746758|Behavioral|SMS text messaging referral|The text messaging system has been designed to use codes of reproductive health conditions and their treatments. Text messages are sent by drug stores and received at the dispensaries, forwarded by a bespoke software called Snapshot, which captures data online from any computer anywhere by use of a login for confidentiality.
16154329|NCT01746745|Drug|[^14C]-LY2940680|Administered as solution by mouth
16154330|NCT01746732|Drug|Ortho-Cyclen|Oral administration
16154331|NCT01746732|Drug|Evacetrapib|Oral administration
16154332|NCT01746719|Drug|Etodolac Capsules USP 300 mg|300 mg capsule once a day
16154333|NCT01746719|Drug|Etodolac|500 mg tablet once a day
16154334|NCT01746706|Device|PET amyloid tracer (Florbetapir F18 AV45 F18|
16154335|NCT01746693|Device|Dynamic Vessel Analyzer|retinal vessel diameter, retinal oxygen saturation
16154336|NCT01746693|Other|Laser Doppler Velocimetry|retinal blood flow velocity, retinal blood flow
16154337|NCT01746693|Device|7-Tesla MRI|High resolution functional and anatomical imaging of the visual pathway
16154338|NCT01746693|Other|Pattern electroretinography|inner retinal function
16154339|NCT01746693|Other|Fourier domain optical coherence tomography|Blood flow in retina.
16154340|NCT01746680|Drug|Tacrolimus with Methotrexate|Tacrolimus 1 mg for 0~week4, 2mg for week4~week8, 3mg for week8~week24 with MTX ≤20mg/week
16154341|NCT01746667|Behavioral|Exposure in vivo|
16154342|NCT01746667|Behavioral|Virtual Reality Exposure Therapy|
16154343|NCT01746654|Drug|P128-0.1 mg|P-128 at 0.1 mg divided evenly between the nares is administered once in Part A; multiple times in Part B and Part C; and once in Part D.
16154344|NCT01746654|Drug|P128-0.3 mg|P-128 at 0.3 mg divided evenly between the nares is administered once in Part A; multiple times in Part B and Part C; and once in Part D.
16154345|NCT01746654|Drug|P128-1.0 mg|P-128 at 1.0 mg divided evenly between the nares is administered once in Part A; multiple times in Part B and Part C; once in Part D.
16154346|NCT01746654|Drug|Placebo|Placebo was administered to both nares once in part A, multiple times in Part B and Part C, Once in part D
16154347|NCT01746641|Drug|Remifentanil|
16154348|NCT01746641|Drug|Propofol|
16154349|NCT01746628|Procedure|Hysterectomy with FloSeal|Evaluation of the effects of intrauterine FloSeal
16154350|NCT01746615|Device|Dynamic Vessel Analyzer|retinal vessel diameter & oxygen saturation
16154351|NCT01746615|Other|Bidirectional Fourier-Domain Optical Coherence Tomography (FDOCT)|retinal blood velocity
16154352|NCT01746602|Drug|Timoptic® 0.5%|Timoptic® 0.5% Eye Drops, Merck, single instillation
16154353|NCT01746602|Drug|Timophtal sine® 0.5%|Timophtal sine® 0.5%, Agepha, Eye Drops, single instillation
16154354|NCT01746602|Device|Genteal HA®|Genteal HA® Eye Drops, Novartis, single instillation
16154355|NCT01746602|Device|Hylo-Comod®|Hylo-Comod® Eye Drops, Croma-Pharma, single instillation
16154356|NCT01746602|Device|Thealoz®|Thealoz® Eye Drops, Thea, France, single instillation
16154357|NCT01746589|Device|bilateral myopic LASIK|200 kHz WaveLight® FS200 Femtosecond Laser and the WaveLight® Allegretto Wave® Eye-Q Laser
16154358|NCT01746576|Other|Use of impedance threshold device during spontaneous ventilation|
16154359|NCT01746563|Drug|Ranibizumab|Intravitreal injection
16154360|NCT01746563|Procedure|Laser therapy|Laser therapy
16154361|NCT01746550|Device|MD-12-001 Stent|MD-12-001 is a self-expanding nitinol stent
16154362|NCT01746524|Device|ATTUNE Primary Total Knee Arthroplasty|Patients will undergo a primary, cemented total knee replacement using one of the four configurations of the Attune knee (CR FB, PS FB, CR RP, PS RP).
16154363|NCT01746511|Procedure|Phototherapy|Light therapy is used to treat cases of neonatal jaundice through the isomerization of the bilirubin and consequently transformation into compounds that the newborn can excrete via urine and stools.
16154364|NCT01746511|Drug|glycerin suppository|Promotes stooling through rectal stimulation and softening of stool. Given every 8 hours rectally. A pediatric glycerin suppository is 1.2 grams. All infants in this study arm will receive our standard dose of glycerin suppository which is 0.25 of the pediatric suppository or 0.3 grams.
16154365|NCT01746498|Procedure|Direct current stimulation using Anodal electrode|11 patients who received real anodal tDCS on the left DLPFC, 2 mA for 20 minute every day for 10 consecutive days
16154366|NCT01746498|Procedure|direct current stimulation using cathodal electrode|11 patients who received real cathodal tDCS on the left DLPFC, 2 mA for 20 minute every day for 10 consecutive days
16154367|NCT01746498|Procedure|Sham direct current stimulation|11 patients who received sham anodal tDCS on the left DLPFC just for few seconds, 2 ma, every day for 10 consecutive days
16154368|NCT01746485|Drug|UT-15C|
16154369|NCT01746472|Behavioral|Facebook app - condition t|Application components hypothesized to increase the duration (t, time) that a participant spends using the application.
16154370|NCT01746472|Behavioral|Facebook app - condition z|Application components hypothesized to increase the number of friends that a user has that are eligible to install the application.
16154772|NCT01743378|Procedure|TAP Block Saline 0,9 %|
16154371|NCT01746472|Behavioral|Facebook app - condition B-active|Application components hypothesized to increase the contagiousness of the app by increasing a users ability and desire to proactively contact others.
16154372|NCT01746472|Behavioral|Facebook app - condition B-passive|Application components hypothesized to increase the contagiousness of the app by increasing the passive diffusion of information from the user to their friends.
16154373|NCT01746459|Other|Paper-Based Reminder System|Paper-based reminders include: a) affixing stickers to clients' bedroom doors, beside their beds, or in their bathrooms; b) posting signs in prominent locations; and c) placing colored flags on the documentation flowsheets.
16154374|NCT01746459|Other|Peer-Based Reminder System|Healthcare aides will provide formal and informal peer reminders about the mobility activity; the formal reminders will take place either monthly or every three months during change of shift meetings, while the informal reminders will be provided as opportunities arise during the work day.
16154375|NCT01746446|Other|Care team|Provides additional support to patients, family, and friends.
16154376|NCT01746433|Other|Sitting up|"The patient is positioned on a Winncare type bed dressed with a pressure-sensor sheet and equipped with either a hanging triangle bar (supporting arm of the bar is adjusted to 30 degrees) or an ERGONOME device according to randomization.
~The patient is first installed on the bed in a strictly supine position, the pelvis centered, and the greater trochanter over the fold of the backrest.
~The investigator then gives instructions on how to use the randomized device (correct hand placement).
~The patient is asked to sit up twice (two consecutive attempts). The first attempt is a learning attempt. The observations necessary for this study will be taken on the second attempt. Thus the second sitting attempt is timed, video-taped and recorded via the pressure-sensor sheet beneath the patient."
16154377|NCT01746420|Drug|rhPDGF-BB Injection|Comparison of placebo control (0 mg rhPDGF-BB) and different dosages (0.45, 0.75, 1.5, and 3.0 mg) of rhPDGF-BB Injection administered through a one-time injection
16154378|NCT01746420|Drug|Placebo|sodium acetate buffer (0 mg rhPDGF-BB)
16154379|NCT01746394|Behavioral|Parents as Teachers Enhanced|Participants will receive the same monthly Parents as Teachers (PaT) lessons and materials at each home visit as the PaT arm. Additionally, these mothers will receive the enhanced nutrition and physical activity lessons and materials which will follow the family well-being format of the PaT lessons. The StartSmart lessons will focus on healthy gestational weight gain, diet, physical activity, breastfeeding, weight management, healthy eating, food shopping, meal preparation, physical activity, proper infant feeding, and infant activity time.
16154380|NCT01746394|Behavioral|Parents as Teachers|Participants will receive monthly Parents as Teachers (PaT) lessons and materials at each home visit. The Parent Educator will first connect with the mother by discussing or reviewing content from the prior visit; reflect on the mother's experience with continuing the parent-child activity from the prior visit; and agree on what will happen during the current visit. For the lesson plan, the Parent Educator will cover the following three areas using discussion, activities, and handouts: parent-child interaction, develop-centered parenting, and family well-being. In closing, the Parent Educator will review and evaluate the visit, talk about the mother's next step, and plan for the next visit.
16154381|NCT01746381|Device|Non-invasive home ventilation|A ventilator and mask will be provided to patients according to standard procedures used at the National Program of Home Ventilatory Assistance of the Montreal Chest Institute, adjusted during a daytime outpatient trial, with close follow-up as described in study protocol.
16154382|NCT01746368|Other|The Nurse-Supported Advance Care Planning Intervention|This intervention was a manualized education, support, and guidance session provided by a Registered Nurse that included information about risks, benefits, and alternatives of specific choices. It incorporated an application of the Theory for Enabling Safety.
16154383|NCT01746368|Other|Care-as-Usual|The Care-as-Usual was a session with the social worker who explained what the Advance Directive is, and guided the Veteran regarding the process of completing the Advance Directive document, without providing information about risks, benefits, and alternatives of specific choices.
16154384|NCT01746355|Procedure|rTMS|Patients undergoing of repetitive transcranial magnetic stimulation for treatment of AFP.
16154385|NCT01746342|Device|Effective continuous positive airway pressure (CPAP)|
16154386|NCT01746342|Device|Sham continuous positive airway pressure (CPAP)|
16154387|NCT01746329|Other|Tea|Oral intake of tea containing 75 grams of glucose
16154388|NCT01746329|Other|Beet root|Oral intake of beetroot juice containing 75 grams of glucose
16154389|NCT01746329|Other|Placebo|Oral intake of 75 grams of glucose in water
16154390|NCT01746303|Dietary Supplement|Omega-3 fatty acid|A fixed dose of 2.4 g/day (EPA: 1.6 g, DHA: 0.8 g; 4 capsules/d).
16154391|NCT01746303|Dietary Supplement|Blueberry powder|Whole, freeze-dried blueberry powder made of 50%:50% mixture of Tifblue and Rubel blueberries.
16154392|NCT01746303|Other|Placebo oil|Corn oil capsules that are identical in size, shape, and color to omega-3 capsules.
16154393|NCT01746303|Other|Placebo powder|Placebo powder matched for color, taste, and sugar content as closely as possible and milled similarly to the blueberry powder.
16154394|NCT01746290|Other|PulsePoint notification|When the smartphone receives the alert data, the phone alarms with auditory, tactile (vibration) and visual stimuli (Figure 1). After acknowledgement of the alert by the user, the application presents a map and text information to direct the user to the exact location of the emergency. Using local AED registry data, the application can also reveal exact AED locations in the vicinity of the emergency
16154395|NCT01746277|Drug|combined group|chemotherapy with docetaxel 75mg/m2 d1 or pemetrexed 500mg/m2 d1, every 3 weeks,at least 2 cycles and the maximal cycle is 6 depending on disease evaluation and patient's physical condition combined with gefitinib 250mg once per day from the start day of chemotherapy until disease progression or intolerable side effects.
16154396|NCT01746277|Drug|Sequenced group|sequenced group chemotherapy with docetaxel 75mg/m2 d1 or pemetrexed 500mg/m2 d1, every 3 weeks,at least 2 cycles and the maximal cycles is 6 depending on disease evaluation or patient's physical condition sequenced by gefitinib 250mg once per day until disease progression or intolerable side effects.
16154397|NCT01746264|Dietary Supplement|Vitamin D3|Vitamin D 3 at 100,000 IU once a month for 3 months
16154398|NCT01746251|Drug|Afatinib|
16154402|NCT01746225|Drug|nab-Paclitaxel|Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)
16154403|NCT01746212|Procedure|One-level or two-level anterior lumbar interbody fusion|Patients electing to receive a one-level or two-level, anterior approach only (incision through the front), lumbar interbody fusion in order to treat degenerative disc disease (at one or two levels in the spine), and meeting all other inclusion criteria, are eligible for enrollment into the study.
16154404|NCT01746212|Biological|InQu Bone Graft Extender and Substitute mixed with BMAC|Surgeries utilizing InQu Bone Graft Extender and Substitute during the anterior lumbar interbody fusion surgical procedure will be elected for inclusion. InQu will be mixed with BMAC (bone marrow aspirate concentrate), which will be prepared using the SmartPRep2 centrifuge. Patients opting to use a grafting alternative will not meet inclusion criteria, and will not be eligible to enroll in this study.
16154405|NCT01746212|Device|Synthes Spinal Instrumentation|Synthes Spinal Instrumentation will be used during surgery as spinal stabilization.
16154406|NCT01746199|Drug|cotrimoxazole daily prophylaxis|
16154407|NCT01746199|Drug|sulphadoxine-pyrimethamine|Intermittent preventive sulphadoxine-pyrimethamine treatment
16154408|NCT01746173|Drug|Cyclophosphamide|
16154409|NCT01746173|Drug|Doxorubicin|
16154410|NCT01746173|Drug|Vincristine|
16154411|NCT01746173|Drug|Etoposide|
16154412|NCT01746173|Drug|Prednisone|
16154413|NCT01746173|Drug|Filgrastim|
16154414|NCT01746173|Drug|Plerixafor|
16154415|NCT01746173|Procedure|Stem Cell Collection|
16154416|NCT01746173|Drug|Palifermin|
16154417|NCT01746173|Drug|Gemcitabine|
16154418|NCT01746173|Drug|Busulfan|
16154419|NCT01746173|Drug|Melphalan|
16154420|NCT01746173|Procedure|Stem Cell Transplant|
16154421|NCT01746160|Drug|C1 Implant|Patients treated with dental implants.
16154422|NCT01746147|Other|No intervention and study treatment|
16154423|NCT01746121|Genetic|Salivary and blood sampling, as part of routine care. Collection of exfoliated teeth.|
16154424|NCT01746108|Biological|Synflorix™|1 or 2 doses depending on the priming status, intramuscularly in the non-dominant deltoid muscle or the thigh.
16154425|NCT01746095|Drug|Vancomycin hydrochloride inhalation powder|There will be two treatment cohorts in this study, each comprised of 40 randomized (1:1 active to placebo) and treated patients (adults ≥18 and children ≥12 years of age). In Cohort 1, patients will be enrolled and randomized to receive the 32 mg dose of AeroVanc bid or placebo bid. Prior to starting enrollment in Cohort 2, a safety evaluation will be carried out by the Data Monitoring Committee (DMC) based on treatment data from the first 20 patients in Cohort 1. Subject to the Sponsor's written communication of the DMC's opinion of acceptable safety, the dose for the active arm in Cohort 2 will be escalated to 64 mg bid. Optionally, the active arm for Cohort 2 may also be kept the same (32 mg bid), or reduced to 16 mg bid, depending on the outcome of the DMC's safety evaluation.
16154426|NCT01746095|Drug|Placebo inhalation powder|
16154427|NCT01746082|Biological|Influenza A/H3N2 variant Vaccine|Investigational influenza virus H3N2v vaccine, a monovalent type A inactivated vaccine (H3N2v MIV) for intramuscular use, is a sterile clear and slightly opalescent suspension prepared from influenza virus propagated in embryonated chicken eggs. The H3N2v MIV contains no preservative. Subjects will be stratified by age (approximately 100 (up to 120) subjects 18-64 years old and approximately 100 (up to 120) subjects >/=65 years old) to receive two doses of H3N2v MIV, delivered intramuscularly as 15 micrograms (mcg) of hemagglutinin (HA)/0.5 milliliter (mL) dose, 21 days apart
16154428|NCT01746069|Behavioral|Quit smoking combined cessation programme|Support sms messages to patient's mobile phone and health advice
16154429|NCT01746069|Behavioral|health advice|routine clinical practice
16154430|NCT01746056|Device|Occlusive Heat Patch|The heat patch will be applied for 2 hours every day for a period of 12 weeks.
16154431|NCT01746043|Drug|Armodafinil|150 mg by mouth once a day for 6 weeks.
16154432|NCT01746043|Other|Placebo|1 capsule by mouth 2 times a day for 6 weeks.
16154433|NCT01746043|Drug|Minocycline|100 mg by mouth 2 times a day for 6 weeks.
16154434|NCT01746043|Behavioral|Questionnaires|Completion of symptom questionnaires before chemoradiation and then 1 time a week during Weeks 1-10 of the study. Questionnaire take up to 5 minutes to complete.
16154435|NCT01746017|Drug|Placebo|Administered orally as capsules
16154436|NCT01746017|Drug|LY2922470|Administered orally as capsules
16154437|NCT01746004|Drug|[^14C]-LY2157299|[^14C]-LY2157299 monohydrate administered as oral solution
16154438|NCT01745991|Device|CoSeal spray|
16154439|NCT01745978|Procedure|Precut papillotomy|
16154440|NCT01745965|Drug|T-DM1|
16154441|NCT01745965|Drug|Trastuzumab|
16154442|NCT01745952|Device|figure-of-eight active rTMS coil|navigated rTMS over epileptogenic focus using figure-of-eight active rTMS coil
16154443|NCT01745952|Device|round active rTMS coil|navigated rTMS over epileptogenic focus using round active rTMS coil
16154444|NCT01745952|Device|sham rTMS coil (figure-of-eight)|commercially available placebo coil that provides slight sensory stimulation and discharge noise without stimulating cortical tissue
16154445|NCT01745939|Other|Lumbar Manipulation|Manual therapy intervention
16154446|NCT01745939|Other|Sham manipulation|Manual therapy intervention
16154447|NCT01745926|Device|MECHANICAL CHEST COMPRESSION|
16154448|NCT01745913|Device|CliniMACS® CD34 Reagent System|If a subject is randomized to the haplo-cord transplant group, their family member will undergo a stem cell collection. The stem cells from the haplo-identical donor will be purified by a procedure called CD34 selection before they are given to the subject. A special device called the CliniMACS® CD34 Reagent System, which is not FDA approved, will be used for this purpose. The manufacturer of the device, Miltenyi Biotec, is providing the researchers access to the device for use in this research study. Because the stem cells from the haplo-identical donor are treated using the CliniMACS CD34 selection device, they cells are considered investigational.
16154449|NCT01745913|Drug|Fludarabine|Fludarabine: 30 mg/m2 /day intravenously x 5 days total dose 150 mg/m2. Fludarabine will be dosed according to actual body weight
16154773|NCT01743365|Drug|Cisplatin-5FU-Afatinib|
16154450|NCT01745913|Drug|Melphalan|Melphalan: 70mg/m2/day intravenously x 2 days. Melphalan will be dosed according to actual body weight. Cryotherapy with ice chips will be administered to prevent mucositis.
16154451|NCT01745913|Drug|Rabbit ATG|Rabbit ATG (rATG): 1.5 mg/kg/day intravenously x 4 days, total 6 mg/kg. ATG will be dosed according to actual body weight. The first dose will be infused over at least six hours, and subsequent doses over at least 4 hours. Pre-medications include acetaminophen 650 mg by mouth, diphenhydramine 25-50 mg by mouth or intravenously, and methylprednisolone 2 mg/kg (1 mg/ kg at the initiation and 1 mg/kg half-way through anti-thymocyte globulin administration).
16154452|NCT01745913|Procedure|Double Umbilical Cord Blood Transplantation|All subjects will receive an UCB dose of > 3 x107/kg nucleated blood cells. It is expected that this will require co-infusion of two UCB in the large majority of cases. If two UCB are required, they will be at least 4/5 matched to the recipient.
16154453|NCT01745913|Procedure|Haplo-Identical Cord Transplantation|"If randomized to the haplo-cord group, a family member will undergo a stem cell collection. In both arms, subjects will receive a conditioning regimen prior to transplantation. The conditioning regimen utilized in this study incorporates fludarabine-Melphalan and antithymocyte globulin (ATG). This regimen has the advantage of being nearly identical to the regimen utilized for our haplo-cord regimen is based on the experience of the Dana-Farber/Mass-General regimen."
16154454|NCT01745887|Drug|EBI-005-2|The investigational drug EBI-005-2, is an intervention to three different study arms. One arm gets 5mg/ml, the other gets 20mg/ml and the last arm is Placebo.
16154455|NCT01745861|Dietary Supplement|Lipidem (Omega-3 fish oil lipid emulsion)|Lipidem 200 mg/ml daily infusion for 7 days maximum
16154456|NCT01745861|Dietary Supplement|Lipofundin® MCT/LCT 20%|Lipofundin® MCT/LCT 20% daily infusion for 7 days
16154457|NCT01745848|Drug|Roflumilast|
16154458|NCT01745835|Drug|2L Coolprep®|* Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g
16154459|NCT01745835|Drug|1L Coolprep® and Bisacodyl|"Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea)
~* Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g
~Dulcolax-S® (Boehringer Ingelheim ,Seoul, Korea) * composition /1 tablet : Bisacodyl 5mg, docusate sodium 16.75mg"
16154460|NCT01745822|Drug|tenofovir disoproxil fumarate|administration: tablet 300 mg, once a day, from enrollment at 28 weeks' gestation until 2 months postpartum
16154461|NCT01745822|Drug|placebo|administration: one tablet, once a day, from enrollment at 28 weeks' gestation until 2 months postpartum
16154462|NCT01745809|Procedure|Bronchoscopy|Subjects will have a screening visit and, if they qualify to take part in the study, they will undergo a single bronchoscopy procedure. During the bronchoscopy, bronchoalveolar lavage (BAL) and bronchial brushings will be performed on each subject.
16154463|NCT01745783|Other|Bone marrow mesenchymal stem cells autologous|Infusion of mesenchymal cells from autologous bone marrow in a dose of 1-2x106 cells / kg
16154464|NCT01745783|Other|Placebo comparator|Lactated Ringer's solution, 2.5% glucose and 1% human albumin.
16154465|NCT01745770|Drug|Mesalazine - TID 1000 mg|
16154466|NCT01745770|Drug|Mesalazine - TID 2x 500 mg|
16154467|NCT01745757|Drug|Bevacizumab|Treatments received by patients in this study are prescribed in the context of standard care
16154468|NCT01745757|Drug|paclitaxel|Treatments received by patients in this study are prescribed in the context of standard care
16154469|NCT01745744|Other|Mesenchymal stem cells from adipose tissue|- Infusion of mesenchymal stem cells from adipose tissue administered intraarterially: 0.5x106 cells / kg of patient weight and 1x106 cells / kg of patient weight.
16154470|NCT01745731|Other|Cell infusion intraportal mononuclear bone marrow autologous and portal embolization of the affected segments.|Proceeds to selective application of stem cells in the portal branches of segments II and III as 10 ml aliquots of taking a time of 4 minutes between each application.
16154471|NCT01745718|Other|Cytological imprints|Each targeted biopsy is subject to cytological imprints. It causes no extra biopsies or extra discomfort for the patients
16154472|NCT01745705|Other|Cervical Spine Manipulation|
16154473|NCT01745705|Other|Manual Contact|
16154474|NCT01745692|Device|Mechanical thrombectomy|
16154475|NCT01745692|Drug|Intravenous rtPA|All patients receive IV alteplase
16154476|NCT01745679|Drug|Ceftriaxone treatment|ceftriaxone will be administered à high dose : > or equal to 75mg/kg/day or 4 gr/day
16154477|NCT01745666|Other|exercise test|Exercise test : Bruce protocol : exercise during 7 minutes, and rest during 6 minutes with registering of the electrocardiograms.
16154478|NCT01745666|Other|Epinephrine test|Epinephrine test : 1 hour after exercise test : epinephrine infusion during 20 minutes, and monitoring during 30 minutes after stop infusion with registering of electrocardiograms.
16154479|NCT01745653|Device|Low level laser therapy|
16154480|NCT01745653|Procedure|sham procedure|
16154481|NCT01745640|Drug|POMALIDOMIDE|hard capsule 4mg/day, oral route, from day 1 to 21 per 28 days cycle
16154482|NCT01745640|Drug|Dexamethasone|40mg (if patient <75 years)/20mg weekly, oral route, on day 1, 8, 15, 22 per 28 days cycle
16154483|NCT01745627|Device|755nm Alex laser|
16154484|NCT01745614|Drug|Nimesulide 100 mg tablets|Reference product
16154485|NCT01745614|Drug|Nimesulide 100 mg tablets|Test product
16154486|NCT01745601|Drug|escitalopram 10 mg|Reference product
16154487|NCT01745601|Drug|escitalopram 10 mg|Test product
16154488|NCT01745588|Drug|Pomalidomide|
16154489|NCT01745588|Procedure|stem cell|
16154490|NCT01745588|Drug|Dexamethasone|
16154491|NCT01745588|Drug|Clarithromycin|
16154492|NCT01745575|Drug|Alprazolam 2mg tablets|Reference product
16154493|NCT01745575|Drug|Alprazolam 2 mg tablets|Test product
16154494|NCT01745562|Drug|Alprazolam 0.5 mg|Reference product
16154495|NCT01745562|Drug|Alprazolam 0.5 mg|Test product
16154496|NCT01745549|Device|Needle for insulin pen, 4 mm long and with a diameter of 33 gauge|
16154497|NCT01745549|Device|Needle for insulin pen, 4 mm long and with a diameter of 32 gauge|
16154542|NCT01745133|Drug|calcipotriene|clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day every day for 8 weeks
16154498|NCT01745536|Procedure|Oocytes are vitrified/stored using a closed device|Vitrification will be carried out using a modification of the current device (Cryotop®), thus providing air tight sealing. Closed systems are devices that are hermetically sealed before vitrification and remain sealed during storage.
16154499|NCT01745536|Procedure|Oocytes are vitrified/stored using an open device|The vitrification process takes place through direct contact with liquid nitrogen. The system has an external straw to protect the samples during storage, but the device is not hermetically sealed.
16154500|NCT01745523|Procedure|Synthetic macromolecule HPC and trehalose|Oocytes are vitrified using the synthetic macromolecule HPC and trehalose
16154501|NCT01745523|Procedure|SSS containing HSA and sucrose|• Oocytes are vitrified using the SSS containing HSA and sucrose
16154502|NCT01745510|Dietary Supplement|Docosahexaenoic acid (DHA)|Docosahexaenoic acid from algae source
16154503|NCT01745510|Dietary Supplement|Placebo|Placebo was designed to mimic the color and consistence of the oil that contains DHA
16154504|NCT01745497|Drug|Ferrous sulfate|3mg/kg liquid
16154505|NCT01745497|Drug|Placebo|Equivalent volume of liquid with similar color and taste.
16154506|NCT01745484|Other|SPECT-based treatment plan|"SPECT will be performed on all patients at baseline. Two treatment plans will be made- functional SPECT-based plan and conventional CT-based plan. Randomization will take place if both plans are satisfying established criteria for tumour coverage and normal tissue sparing. Randomization between Arm 1 and Arm 2 will be done, where the patients will be treated either by SPECT-plan or by CT-plan respectively.
~The SPECT data are viewed as a multicoloured image in the spectrum colour setting to allow accurate volume contouring around a predefined colour. The threshold level is adjusted individually for each patient in order to match the size of the SPECT image within the lung volumes defined on CT. A new contour of functional lung is created from the SPECT images using a threshold of 30% of the maximum uptake for each patient. A treatment plan is generated. The principal objective for each plan is to minimize the volume of lungirradiated"
16154507|NCT01745458|Drug|SB-659032|
16154508|NCT01745458|Drug|Placebo|Matched placebo
16154509|NCT01745445|Other|concurrent chemo-radiotherapy arm|VP-16 50 mg/m2 on day 1-5 and Carboplatin AUC = 5 on day 1 will be given by intravenous infusion for 3-4 cycles. Then a total dose of 60 Gy will be given in 30 fractions of 2 Gy, 5 fractions per week; Starting the first cycle of concurrent chemotherapy at the first day of radiotherapy. The chemotherapeutic scheme is intravenous infusion of Cisplatin 25mg/m2 on day 1-3 and oral administration of Etoposide 100mg on day1-5 and 3 weeks as a cycle for 2 consecutive cycles.
16154510|NCT01745432|Device|ADBLOCK|Laparoscopic surgery
16154511|NCT01745393|Behavioral|Clinic Quality Improvement + Behavioral Counseling|
16154512|NCT01745393|Behavioral|Clinic Quality Improvement + Attention Control|
16154513|NCT01745380|Drug|Tetracaine HCl 3% and Oxymetazoline HCl 0.05%|The study drug is regional anesthetic delivered intranasally on the same side as the operative tooth
16154514|NCT01745380|Drug|Placebo|The placebo spray was identical in appearance to and was administered in the same volume and manner as the active ingredient.
16154515|NCT01745367|Drug|Tivozanib Hydrochloride|
16154516|NCT01745367|Drug|paclitaxel|
16154517|NCT01745367|Drug|Placebo|
16154518|NCT01745354|Drug|SD-101|SD-101 will be administered after radiation to only the largest palpable lymph node as an intratumoral injection weekly for 3 weeks at three dosing cohorts: 0.3 mg, 1 mg, and 3 mg
16154519|NCT01745354|Radiation|Local Radiation|
16154520|NCT01745328|Drug|LVX-AMX|Subjects were treated with Levofloxacin, 200mg bid, Amoxicillin, 500mg tid for 1 week, followed by 3 week of placebo.
16154521|NCT01745328|Drug|TCM|Subject is treated with TCM for 4 weeks.
16154522|NCT01745328|Drug|LVX-AMX|treatment with placebo from 2 to 4 weeks.
16154523|NCT01745315|Device|Advanced bipolar devices|
16154524|NCT01745302|Drug|TCM|TCM: In China,TCM herbs are given on the basis of the TCM syndrome differentiation as diagnosed by the TCM herbal specialist. Prescriptions formulated into granules origin from Professor Liu Jia-xiang in Longhua hospital. Package of granules is made into three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe.The herbal treatment is adapted to the syndromes.
16154525|NCT01745302|Drug|EGFR-TKI|Erlotinib 150 mg oral once a day or Gefitinib 250 mg oral once a day or Icotinib 125 mg oral three times a day
16154526|NCT01745276|Device|Biphosfonate|External pins coated by biphosfonate.
16154527|NCT01745276|Device|Hydroxylapatit|External pins coated by Hydroxylapatit.
16154528|NCT01745263|Drug|Vitamin D3|2000 IU/d
16154529|NCT01745263|Drug|Omega 3 fatty acids|"Ratio EPA:DHA = 1:2
~1 g/d"
16154530|NCT01745263|Procedure|Strength Home Exercise|
16154531|NCT01745263|Procedure|Flexibility Home Exercise|
16154532|NCT01745250|Device|Emervel Lips|Lip treatment of both upper and lower lip
16154533|NCT01745250|Device|Juvederm Ultra Smile|Lip treatment of both upper and lower lip
16154534|NCT01745224|Device|Revlite Q switched Nd:YAG|Revlite Q switched Nd:YAG 1064nm
16154535|NCT01745224|Device|Trivantage Q switched Nd: YAG|Trivantage Q switched Nd: YAG 1064nm
16154536|NCT01745211|Device|755nm Alexandrite Laser|755nm Alexandrite laser with array handpiece
16154537|NCT01745172|Procedure|Carotid body excision|"This surgery does not involve any study drug or investigational device.
~The carotid body will be removed by the so called 'lateral approach' or a combined 'lateral and medial approach'. In all cases the target area was defined as the tissue in between the ECA and ICA, up to 5-6mm above the bifurcation point of the common carotid artery into the ECA and ICA. In a lateral approach the carotid bifurcation is not turned. A combined approach includes usually dissection of the superior thyroid vessel and turning of the carotid bifurcation."
16154538|NCT01745159|Drug|tacrolimus|
16154539|NCT01745146|Behavioral|ASMT|8-session, individual, psycho-educational intervention based on principles of self-monitoring and problem-solving training Significant other (friend or relative) invited to participate in 3 of 8 sessions
16154540|NCT01745146|Behavioral|PRE|8-session, individual, psycho-educational intervention based on principles of education and personal readjustment to TBI Significant other (friend or relative) invited to participate in 3 of 8 sessions
16154541|NCT01745133|Drug|vehicle foam|clobetasol propionate 0.05% twice a day for two weeks; then vehicle foam twice a day every day for 8 weeks
16155148|NCT01740544|Other|Sham tDCS|Sham tDCS applied over the right PPC
16154543|NCT01745133|Drug|calcipotriene + clobetasol propionate|clobetasol propionate 0.05% twice a day for two weeks; then calcipotriene 0.005% foam twice a day on weekdays + clobetasol propionate 0.05% foam twice a day on weekends for 8 weeks
16154544|NCT01745120|Genetic|LentiGlobin BB305 Drug Product|Transplant of autologous hematopoietic stem cells transduced with LentiGlobin BB305 lentiviral vector.
16154545|NCT01745107|Radiation|Prophylactic postoperative radiation therapy|Prescription dose of 95%planning target volume(PTV) 50.4Gy/1.8Gy/28fractions for supraclavicular region and 95%PTV 56Gy/2Gy/28fractions for mediastinum which is delivered in 2 months after surgery.
16154546|NCT01745094|Drug|mirabegron|oral
16154547|NCT01745094|Drug|solifenacin|oral
16154548|NCT01745081|Drug|20% mannitol bolus administration|
16154549|NCT01745081|Drug|Hypertonic saline 3% bolus administration|
16154550|NCT01745068|Other|Integrated program|Each participant's primary care physician will receive written information containing a presumed osteoporosis diagnosis, investigations to be performed, correct interpretation of any bone densitometry results in the context of a fragility fracture, and treatment options. The study coordinator will be responsible for orienting the participant to an appropriate local fall prevention program.
16154551|NCT01745055|Drug|CP-690,550 (tofacitinib)|CP-690,550 30 mg q12h for 5 days
16154552|NCT01745055|Drug|Methotrexate (MTX)|individual dose of methotrexate (stably dosed)
16154553|NCT01745042|Other|Clinical exams|Physiological and biochemical tests; quality of life questionnaire; body composition measurement
16154554|NCT01745029|Device|Motilis-3D-transit|
16154555|NCT01745016|Dietary Supplement|Placebo|
16154556|NCT01745016|Dietary Supplement|Beta-alanine|
16154557|NCT01745003|Procedure|Transcranial Direct Current Stimulation (tDCS)|tDCS is based on the application of a weak direct current to the scalp that flows between two relatively large electrodes-anode and cathode. We will be using this device to investigate fibromyalgia.
16154558|NCT01744990|Other|Oral food challenges to multiple nuts|
16154559|NCT01744977|Behavioral|packaging|Intervention provides usual statin medication dispensed in pre-prepared adherence packaging (blister packaging) rather than the previously received prescription bottles
16154560|NCT01744964|Drug|Apomorphine|1.5 mg Apomorphine
16154561|NCT01744951|Behavioral|ADAPT|"ADAPT consists of the following modules/sessions:
~Module 1: Trust, positive coping strategies, and behavior management; Module 2: Developmental understanding of adoption experience; Module 3: Substance abuse prevention; Module 4: Loss and grief issues about birth family and foster care; Module 5: Attachment/joining with adoptive family; Module 6: Search for identity/self -esteem; Module 7: Adoption and the outside world; Module 8: Trauma Treatment (if appropriate)"
16154562|NCT01744938|Procedure|preoperative biliary drainage|percutaneous preoperative biliary drainage guided by CT
16154563|NCT01744925|Drug|Icotinib of routine dose|Icotinib: 125mg, oral administration, three times per day.
16154564|NCT01744925|Drug|Icotinib of high dose|Icotinib: 375mg, oral administration, three times per day.
16154565|NCT01744912|Drug|Ublituximab|Ublituximab is a novel monoclonal antibody targeting CD20
16154566|NCT01744912|Drug|Lenalidomide|Lenalidomide has both immunomodulatory and anti-angiogenic properties which could confer antitumor and antimetastatic effects
16154567|NCT01744899|Other|Sitting posture|The outcomes were measured while the participants assumed erect, slumped and slouched sitting postures.
16154568|NCT01744886|Procedure|maintain oxygenation during one lung ventilation|"All study patients will be placed on a volume controlled mode of ventilation with the following settings: tidal volume between 5 and 10 ml/kg and FIO2 at 50% and 4 cm H2O PEEP. Respiratory frequency and tidal volume will be adjusted to maintain ETCO2 between 30 and 40 mmHg. ETCO2 levels and SpO2 will be monitored continuously.
~If SpO2 declines below 90% the ventilator settings will be adapted according to the following protocol: First the FIO2 is increased to 80%. If this is insufficient FIO2 is increased to 100%. If this remains insufficient 5 cm H2O of CPAP is applied to the non-ventilated lung. If this is still insufficient the surgeon will be asked to allow for temporary recruitment of the non-ventilated lung."
16154569|NCT01744873|Drug|Bisoprolol Fumarate Tablet 10 mg|10 mg tablet once a day
16154570|NCT01744873|Drug|Bisoprolol|10 mg tablet once a day
16154571|NCT01744847|Device|Tracer Hybrid® Wire Guides, Tracer Metro® Direct™ Wire Guide|one guide wire insert to the pancreatic duct and other guide wire insert to the Common bilde duct for cannulation
16154572|NCT01744821|Dietary Supplement|Arm A: Vitamin D3 Group|
16154573|NCT01744821|Dietary Supplement|Placebo|
16154574|NCT01744808|Drug|EB-1020 IR|Immediate release
16154575|NCT01744808|Drug|EB-1020 SR1|sustained release
16154576|NCT01744808|Drug|EB-1020 SR2|Sustained release
16154577|NCT01744808|Drug|EB-1020 SR3|Sustained release
16154578|NCT01744808|Other|Placebo|Placebo formulation
16154579|NCT01744795|Other|induced changes in hemodynamics|Twenty-five patients are planned enrolled. After induction of anesthesia, insertion of the PAC and the CardioQ probe, the patient are placed in the following successive positions: a) supine, b) head-down tilt, c) head-up tilt, d) supine, e) supine with phenylephrine administration f) pace heart rate 80 bpm, g) pace heart rate 110 bpm. CO are measured simultaneously using the TEE and thermodilution technique.
16154580|NCT01744782|Drug|RP103|Cysteamine Bitartrate Delayed-release Capsules (RP103) were administered twice daily, orally or via gastrostomy tube (G-tube), after a 2-hour fast. The starting dose was one-quarter of the RP103 targeted maintenance dose based on age, weight, and body surface area. The recommended targeted maintenance dose for children up to 6 years old was 1 gram/m²/day, in 2 divided doses given Q12H. The dose was gradually escalated, in 10% steps, based on monitoring of WBC cystine levels 30 minutes after the morning RP103 dose collected every 2 weeks, until the participant's WBC cystine level was <1 nmol ½ cystine/mg protein.
16154581|NCT01744756|Drug|Bevacizumab|One subconjunctival aplication of Bevacizumabe 0,5ml
16154582|NCT01744743|Procedure|levothyroxine|Women with TSH≥97.5%th and/or FT4≤2.5%th will accept levothyroxine 150ug daily and follow-up every 4 weeks.
16154583|NCT01744730|Drug|Clindamycin|Schedule includes 30-40 mg/kg/day dosed every 6 or every 8 hours with a maximum daily dose of 2.7 grams/day. Dosing greater than 2.7g/day will be allowed for children receiving clindamycin as part of clinical care.
16154685|NCT01744067|Drug|Omega-3 fatty acids|2,7 g omega-3 fatty acids / day (1 capsule 3 times a day / oral administration)
16154584|NCT01744717|Other|Pain measurement|"Pain intensity will be measured using 2 scales based on behaviour items, the Behavioural Pain Scale (BPS) and the ESCID scale (Escala de Conductas Indicadoras de Dolor), by two independent observers , when applying two procedures registered as painful (PD) and common in clinical practice, and a non-painful procedure (PND). The measurement will be performed once per each patient and procedure.
~The procedures to be studied are the following:
~TURNING / POSITIONING (moving side to side or up or down in bed)
~ENDOTRACHEAL SUCTIONING (insertion of suction catheter into the endotracheal tube or tracheostomy in order to aspirate secretions)
~NON PAINFUL PROCEDURE (Soft friction with gauze cloth on a healthy skin tissue portion, in the outer arm, forearm or anterior tibial area)"
16154585|NCT01744704|Drug|rhNGF 0.5 µg/mL Sentinel|In Part 0, all subjects received one 35-μL drop of rh-NGF at an appropriate concentration in the study eye (right or left) according to the randomisation list to achieve the required dose level
16154586|NCT01744704|Drug|rhNGF 5 µg/mL Sentinel|Part 0 represented a sentinel group.
16154587|NCT01744704|Drug|rhNGF 20 µg/mL Sentinel|In Part 0, all subjects received one 35-μL drop of rh-NGF at an appropriate concentration in the study eye (right or left) according to the randomisation list to achieve the required dose level
16154588|NCT01744704|Drug|rhNGF 20 µg/mL Part A|In Part A, all subjects received one 35-μL drop of rh-NGF at an appropriate concentration or placebo in their study eye (right or left) according to the randomisation list (and 1 drop of placebo in the non-study eye). This occurred q4h on Day 1 to achieve the required fractionated single dose level.
16154589|NCT01744704|Drug|rhNGF 60 µg/mL Part A|In Part A, all subjects received one 35-μL drop of rh-NGF at an appropriate concentration or placebo in their study eye (right or left) according to the randomisation list (and 1 drop of placebo in the non-study eye). This occurred q4h on Day 1 to achieve the required fractionated single dose level.
16154590|NCT01744704|Drug|rhNGF 180 µg/mL Part A|In Part A, all subjects received one 35-μL drop of rh-NGF at an appropriate concentration or placebo in their study eye (right or left) according to the randomisation list (and 1 drop of placebo in the non-study eye). This occurred q4h on Day 1 to achieve the required fractionated single dose level.
16154591|NCT01744704|Drug|rhNGF 20 µg/mL Part B|In Part B, as planned 3 dose levels of rh-NGF or placebo eye drops were studied in a total of 40 healthy subjects.
16154592|NCT01744704|Drug|rhNGF 60 µg/mL Part B|In Part B, all subjects received one 35-μL drop of rh-NGF at an appropriate concentration or placebo in their study eye (right or left) according to the randomisation list (and 1 drop of placebo in the non-study eye). This occurred q4h for 5 days to achieve the required multiple fractionated dose level.
16154593|NCT01744704|Drug|rhNGF 180 µg/mL Part B|In Part B, all subjects received one 35-μL drop of rh-NGF at an appropriate concentration or placebo in their study eye (right or left) according to the randomisation list (and 1 drop of placebo in the non-study eye). This occurred q4h for 5 days to achieve the required multiple fractionated dose level.
16154594|NCT01744704|Drug|Placebo Part A|In Part A, all subjects received one 35-μL drop of rh-NGF at an appropriate concentration or placebo in their study eye (right or left) according to the randomisation list (and 1 drop of placebo in the non-study eye). This occurred q4h on Day 1 to achieve the required fractionated single dose level.
16154595|NCT01744704|Drug|Placebo Part B|In Part B, all subjects received one 35-μL drop of rh-NGF at an appropriate concentration or placebo in their study eye (right or left) according to the randomisation list (and 1 drop of placebo in the non-study eye). This occurred q4h for 5 days to achieve the required multiple fractionated dose level.
16154596|NCT01744691|Drug|Ibrutinib|All subjects will receive ibrutinib 420 mg (3 x 140-mg capsules) orally once daily.
16154597|NCT01744678|Behavioral|blue-wavelength enriched ceiling light|Subjects will be in the experimental break room for four 20-minute periods for each Orbit 1 work shift.
16154598|NCT01744678|Behavioral|mild exercise|Subjects will be asked to achieve 65% of maximum heart rate on either a treadmill or exercise cycle for 10-minutes, three times during each Orbit 1 work shift.
16154599|NCT01744665|Drug|nilotinib|Nilotinib will be provided as 150 mg capsules. Patients will take nilotinib 300mg twice daily on study and dose modifications to 450mg once daily is permitted per protocol.
16154600|NCT01744652|Drug|Crizotinib|"Arm A Crizotinib dose: 250 mg by mouth twice a day in a 28 day cycle. Crizotinib Expansion dose: 250 mg by mouth twice a day in a 28 day cycle.
~Arm B Crizotinib starting dose: 250 mg by mouth every other day in a 28 day cycle. Crizotinib Expansion Dose: MTD from dose escalation group."
16154601|NCT01744652|Drug|Dasatinib|"Arm A Dasatinib starting dose: 50 mg by mouth daily in a 28 day cycle. Arm A Dasatinib Expansion Dose: MTD from dose escalation group.
~Arm B Dasatinib dose: 140 mg by mouth daily in a 28 day cycle. Arm B Dasatinib Expansion Dose: 140 mg by mouth daily in a 28 day cycle."
16154602|NCT01744639|Behavioral|HCC under treatment with radioablation|The evaluation will take place over a period of 30 days.
16154603|NCT01744626|Drug|CC-292|Cohort 1: 375 mg CC-292 will be administered twice a day on Days 1-28 Cohort 2: 500 mg CC-292 will be administered twice a day on Days 1-28
16154604|NCT01744626|Drug|Rituximab|Cohort 1: Rituximab once per cycle Cohort 2: Rituximab once per cycle
16154605|NCT01744600|Behavioral|Music Therapy|The music therapy intervention will consist of individual active music therapy session each week for a period of 22 weeks. Each session will last 30 minutes.
16154606|NCT01744587|Other|Epigallocatechin Gallate (EGCG)|EGCG 600 mg per day will be provided to the test group.Four capsules will be taken daily (2# bid) by the test individuals.
16154607|NCT01744587|Dietary Supplement|Placebo|Placebo qd (2# bid) for 3 years
16154608|NCT01744574|Other|Placebo|Placebo - subjects will take 200 mg twice daily orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date.
16154609|NCT01744574|Drug|Progesterone|The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). All subjects will take 200 mg twice daily orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date.
16154610|NCT01744574|Other|Smoking Cessation Behavioral Counseling|Subjects will receive weekly smoking cessation behavioral counseling.
16154611|NCT01744561|Behavioral|Exercise Intervention|Add three hours of intense physical activities per week to baseline activities. Weekly exercise should include at least 30 minutes of strength building activities and at least two hours of aerobic activities. Exercise bouts lasting 20 min or longer will be counted with respect to total weekly training time.
16154770|NCT01743391|Procedure|Office-hysteroscopy with biopsy|
16154612|NCT01744548|Behavioral|tCBT treatment|The UP comprises 4 main treatment components: 1) psychoeducation about emotions and behaviour; 2) changing misappraisals about probabilities and consequences of negative experiences; 3) preventing avoidance of negative emotion triggers; and 4) modifying emotion-driven behaviours (e.g. hypervigilance, withdrawal). The manualised tCBT intervention will be adapted in order to account for a United Kingdom (UK) audience (as the manual was developed in the United States) and older people (as the manual was developed for working-age people).
16154613|NCT01744535|Behavioral|"My Meal Mate (smartphone application)"|"A smartphone application called My Meal Mate (MMM) designed to facilitate weight loss. The app allows system users to set a goal for weight loss and self monitor diet and activity in an electronic diary. Users receive instant nutritional feedback and feedback via text message."
16154614|NCT01744535|Behavioral|Paper food diary|"The paper food diary is provided by a commerical slimming organisation called Weight Loss Resources. The diary allows the user to record daily food and drink consumed. It is accompanied by a book which provides a database of the nutritional content of 40,000 food and drinks. The diary also encourages participants to record their physical activity."
16154615|NCT01744535|Behavioral|Online food diary|"The online food diary is provided by a commerical slimming organisation called Weight Loss Resources. The electronic diary allows the user to record daily food and drink consumed. System users are also encouraged to record their physical activity."
16154616|NCT01744522|Procedure|Leech therapy|Leech therapy: Using medicinal leeches After piercing the skin and injecting anticoagulants (hirudin) and anaesthetics, they suck out blood of the incision. After 30 to 60 minutes they fall off and the wound -after a short time of after-bleeding- is bandaged up.
16154617|NCT01744509|Device|Capsule colonoscopy;|All the enrolled patients underwent all the three study procedures; the colon capsule is the intervention under evaluation; the other 2 procedures (Ct colonography and optcal colonoscopy contribute to build the composite reference standard)
16154618|NCT01744496|Drug|Rotigotine|Patches will contain 4 mg / 24 h (20 cm^2), 6 mg/ 24 h (30 cm^2), or 8 mg /24 h (40 cm^2) of Rotigotine. Application of study medication starts at the Baseline Visit. Rotigotine will be administered once daily starting at 4 mg / 24 h. Doses will then be up-titrated in weekly increments of 2 mg / 24 h until optimal or maximum dose (16 mg / 24 h) is reached and the Maintenance Period can be started. The duration of the Titration Period will vary from 1 to 7 weeks ± 3 days. The Maintenance Period will last 12 weeks ± 5 days. Thereafter, during the De-escalation Period, the dose of study medication will be decreased by 2 mg / 24 h every other day. The De-escalation Period may last up to 12 days.
16154619|NCT01744496|Drug|Placebo|Placebo patches match the size of active patches 20 cm^2, 30 cm^2, or 40 cm^2 and will contain Placebo. Application of Placebo patches starts at the Baseline Visit. Placebo patches will be administered once daily starting with the equivalent of 4 mg / 24 h. Doses will then be up-titrated in weekly equivalents to 2 mg / 24 h until either optimal dose or maximum dose is reached. The maximum dose is the equivalent to 16 mg / 24 h. The duration of the Titration Period will vary from 1 to 7 weeks. The Maintenance Period will last 12 weeks ± 5 days. During the De-escalation Period, the dose of Placebo will be decreased by the equivalent to 2 mg / 24 h every other day. The De-escalation Period may last up to 12 days.
16154620|NCT01744483|Device|PVC ETT|Placement of a PVC-cuffed ETT in the setting of emergent intubation.
16154621|NCT01744483|Device|PUC ETT|Placement of a PUC-cuffed ETT in the setting of emergent intubation.
16154622|NCT01744483|Device|PUC-CASS ETT|Placement of a PUC-cuffed in the setting of emergent intubation, followed by continuous aspiration of subglottic secretions for the duration of mechanical ventilation.
16154623|NCT01744470|Drug|Tacrolimus targeted half-dose|
16154624|NCT01744470|Drug|Tacrolimus targeted plain dose|
16154625|NCT01744457|Device|Measurement of tear film osmolarity with the TearLab® instrument|
16154626|NCT01744457|Other|Schirmer I test|
16154627|NCT01744457|Other|Tear break up time|
16154628|NCT01744457|Device|Optical Quality Analysis System|Measurement of the objective scattering index (OSI)
16154629|NCT01744457|Other|Ocular Surface Disease Index|
16154630|NCT01744444|Drug|Memantine|Patients will be randomly assigned to start on either memantine or gabapentin. For tolerance reasons, each treatment begins with a progressive increasing dose and stops with a progressive decreasing dose. The duration of the period of last dose (8 to 11 days) will be chosen according to the investigator's availability to organize post-tests.
16154631|NCT01744444|Drug|Gabapentin|Patients will be randomly assigned to start on either memantine or gabapentin. For tolerance reasons, each treatment begins with a progressive increasing dose and stops with a progressive decreasing dose. The duration of the period of last dose (8 to 11 days) will be chosen according to the investigator's availability to organize post-tests.
16154632|NCT01744418|Device|HAVG graft implantation|Patients will be implanted with a Human Acellular Vascular Graft (HAVG) in the forearm or upper arm (arterial anastomosis to the radial or brachial artery, venous anastomosis to either the brachial, cephalic or very central basilica vein) using standard vascular surgical techniques. The graft will be placed in a straight or curved configuration in the first 10 patients. Loop grafts may be permitted in subsequent patients subject to acceptable graft performance at the interim safety review. Placing the graft across the elbow will be avoided.
16154633|NCT01744392|Behavioral|education intervention|Each patient will receive instructions on how to use the medication calendar to help them adhere to their medication regimen. The Meducation Calendar is developed by the clinical pharmacist participating in the research study). The clinical pharmacist will enter the medication regimen for each participant into the application for Meducation Calendar Development.
16154634|NCT01744379|Drug|Lesinurad|
16154635|NCT01744379|Drug|Placebo|
16154636|NCT01744366|Drug|Degarelix|
16154637|NCT01744366|Drug|Goserelin|
16154638|NCT01744353|Drug|Dose level 1|Abraxane 125 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion
16154639|NCT01744353|Drug|Dose level 2/MTD|Abraxane 150 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion
16154640|NCT01744353|Drug|Dose level 3|Abraxane 175 mg/m2 day 1, Oxaliplatin 85 mg/m2 day 1, leuocovorin 400 mg/m2 day 1, F-FU infusion 1200 mg/m2 day x 2 days IV infusion
16154684|NCT01744080|Other|Early Surgery|Patient will proceed to have rotator cuff repair surgery within 3 months of the initial consult with the sport medicine physician.
16154641|NCT01744340|Drug|Head and neck|"Eribulin mesylate is administered by IV infusion over 2-5 minutes on day 1 and 8 of a 21 day cycle 1.4mg/m2 and Cetuximab 400 mg/m2 cycle 1 week 1, then 250 mg/m2/weekly thereafter
~Dose Level 1: 0.7 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 2: 1.0 mg/m2 IV infusion days 1 and 8 of 21 day cycle Dose Level 3: 1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
16154642|NCT01744340|Drug|Colon- Closed as of May 2014|"Eribulin Mesylate:
~1.4 mg/m2 IV infusion days 1 and 8 of 21 day cycle"
16154643|NCT01744314|Drug|Indomethacin and Pantoprazole|
16154644|NCT01744314|Drug|microcrystalline cellulose powder tablets|
16154645|NCT01744301|Drug|Risk of seizure|Patients newly prescribed PPI and H2RA, respectively
16154646|NCT01744288|Drug|Ticagrelor|Oral single loading dose 180ng
16154647|NCT01744288|Drug|Clopidogrel|Oral single loading dose 600mg
16154648|NCT01744288|Drug|ASA|81mg once daily from day -2 up to platelet transfusion
16154649|NCT01744275|Dietary Supplement|Omega 3 fatty acids|
16154650|NCT01744275|Dietary Supplement|corn oil|Placebo
16154651|NCT01744262|Drug|Total intravenous anesthesia|Anesthesia induction with intravenous propofol (effect site concentration 2.5 µg/mL) and remifentanil (effect site concentration 3 ng/mL) using target controlled infusion (TCI). Anesthesia maintenance with propofol effect site concentration 1.5~4 µg/mL and remifentanil effect site concentration 2~5 ng/mL.
16154652|NCT01744262|Drug|Inhalation Anesthesia|Anesthesia induction with intravenous propofol bolus of 1.5~2.5 mg/kg and remifentanil (effect site concentration 3 ng/mL)using target controlled infusion (TCI). Anesthesia maintenance with sevoflurane 1.5~2.0 % and remifentanil effect site concentration 2~5 ng/mL.
16154653|NCT01744249|Drug|Axitinib|Orally, 5mg, twice daily, until progression or until unacceptable toxicity, with or without food intake.
16154654|NCT01744249|Drug|Sandostatin LAR|Intramuscular, 30mg, single injection every 28 days, until disease progression or unacceptable toxicity
16154655|NCT01744249|Drug|Placebo|orally, twice daily, until disease progression or unacceptable toxicity, with or without food intake.
16154656|NCT01744236|Drug|Liraglutide|Liraglutide will be started with a titration period of 2 weeks (week 1: 0.6mg once daily and week 2: 1.2mg once daily). If liraglutide is well tolerated it will be continued for 10 more weeks in a dosage of 1.8mg once daily.
16154657|NCT01744236|Drug|Sitagliptin|Sitagliptin 100mg will be given once daily for 12 weeks.
16154658|NCT01744236|Drug|Exenatide|Exenatide will be administered intravenously with a loading dose of 50ng/min for 30 minutes, followed by a maintenance dose of 25ng/min during the rest of the tests
16154659|NCT01744236|Drug|Liraglutide placebo|Liraglutide-placebo will be started with a titration period of 2 weeks (week 1: 0.6mg once daily and week 2: 1.2mg once daily). It will be continued for 10 more weeks in a dosage of 1.8mg once daily.
16154660|NCT01744236|Drug|Sitagliptin placebo|Sitagliptin-placebo be given once daily for 12 weeks.
16154661|NCT01744236|Drug|Exenatide placebo|Exenatide-placebo (saline) will be administered intravenously
16154662|NCT01744236|Drug|L-NMMA|
16154663|NCT01744223|Biological|BPX-501 dose 1|Subjects will receive 2x10E5 donor T cells/kg genetically modified with BPZ-1001 retroviral vector containing the iCasp suicide gene (BPX-501) after stem cell transplant.
16154664|NCT01744223|Drug|Rimiducid|Dimerizer drug administered by intravenous infusion in those subjects who develop GVHD after infusion of BPX-501 cells.
16154665|NCT01744223|Biological|BPX-501 dose 2|Subjects will receive 5x10E5 donor T cells/kg genetically modified with BPZ-1001 retroviral vector containing the iCasp suicide gene (BPX-501) after stem cell transplant.
16154666|NCT01744223|Biological|BPX-501 dose 3|Subjects will receive 1x10E6 donor T cells/kg genetically modified with BPZ-1001 retroviral vector containing the iCasp suicide gene (BPX-501) after stem cell transplant.
16154667|NCT01744223|Biological|BPX-501 dose 4|Subjects will receive 3x10E6 donor T cells/kg genetically modified with BPZ-1001 retroviral vector containing the iCasp suicide gene (BPX-501) after stem cell transplant.
16154668|NCT01744223|Procedure|SCT|all subjects will receive an alpha beta depleted donor transplant as part of treatment
16154669|NCT01744197|Drug|Synera (lidocaine 70mg/tetracaine 70mg)|All subjects will receive 2 patch applications during this study: one Synera, one placebo. The 2 patch applications must be done on separate days. Only 1 patch will be used per application. Arm 1 subjects will receive Synera patch for the 1st application, and placebo for the second. Arm 2 patients will receive placebo patch for the 1st application, and Synera patch for the second.
16154670|NCT01744184|Drug|Entonox|Entonox arm
16154671|NCT01744184|Drug|Midazolam|up to 5mg midazolam as appropriate
16154672|NCT01744171|Biological|Recombinant Human Hsp110-gp100 Chaperone Complex Vaccine|Given ID
16154673|NCT01744171|Other|Laboratory Biomarker Analysis|Correlative studies
16154674|NCT01744158|Other|No intervention applicable|"Following consent, children will undergo a comprehensive assessment performed by a research team including rehabilitation paediatrician and therapist. Hypertonia and abnormal movements will be assessed by a pediatrician with expertise in treating children with movement disorders. The assessments will be performed at a rehabilitation clinic, or child's home, and will include:
~differentiation of hypertonia by application of the Hypertonia Assessment Tool-Discriminate (HAT-D)
~measurement of severity of dystonia using the Barry Albright dystonia scale, based on video recording
~measurement of severity of spasticity using the modified Ashworth score
~description of presence of chorea or athetosis
~classification of gross motor abilities using the GMFCS and functional mobility scale (FMS)
~classification of fine motor abilities using the manual ability classification system (MACS)
~collection of demographic data and associated medical history"
16154675|NCT01744145|Other|Interventional 40-60|This group will receive the intervention aged 40-60
16154676|NCT01744145|Other|Interventional 60 and above|This group will receive the intervention aged 60 and above.
16154677|NCT01744132|Behavioral|Aim 3: Contract|
16154678|NCT01744119|Device|Vascutek Anaconda™ Stent Graft System|
16154679|NCT01744106|Drug|pseudoephedrine hydrochloride 30 mg tablets|
16154680|NCT01744106|Drug|Placebo tablets|
16154681|NCT01744093|Drug|Doxycycline|100 mg twice daily (BID orally) x 6 months
16154682|NCT01744093|Drug|Placebo (sugar pill)|100 mg twice daily (BID orally) x 6 months
16154683|NCT01744080|Other|Regular Wait Time|Surgery will take place no earlier than 9 months and no later than 12 months after the sport medicine physician consult.
16154686|NCT01744067|Drug|Placebo|Placebo capsules 3 times a day (oral administration)
16154687|NCT01744054|Device|PET/MR|
16154688|NCT01744054|Device|PET/CT|
16154689|NCT01744041|Behavioral|Dyadic Interpersonal Psychotherapy|This intervention consists of a brief psychotherapeutic intervention, Interpersonal Psychotherapy, during pregnancy. Interpersonal Psychotherapy focuses on improving social relationships and interpersonal communication to improve mood. The postpartum phase also utilizes developmentally appropriate strategies to improve the mother-infant relationship.
16154690|NCT01744041|Other|Enhanced Treatment as Usual|This intervention consists of personalized referrals to specialty mental health providers, spiritual counselors, or other needed social services. It includes some non-specific supportive techniques delivered primarily via telephone.
16154691|NCT01744028|Device|Remote Patient Monitoring|Remote patient monitoring system including exacerbations of chronic pulmonary disease Tool - Patient Reported Outcome (EXACT PRO), Lung Monitor, and Pulse Oximeter
16154692|NCT01744028|Other|Usual care|Patients in the usual care arm will continue their normally established procedures of nurse/physician contact and evaluation, as is considered standard for each individual practitioner in the study.
16154693|NCT01744015|Behavioral|Patient Decision Making tool|The experimental group will consist of typical care from the physical therapist (as with the control group) with the addition of the patient decision support tool and information dissemination. The process of information dissemination for informed decision making. Based on the literature, we have deemed three points of informational contact as necessary to improve informed decision making. We plan to inform patients through the use of a) pre-material, b) dialogue, and c) reinforcement means.
16154694|NCT01744015|Other|Standard of care|A control group will receive typical care from the physical therapist. Typical care includes physical therapist directed care of patients with low back pain, using standardized treatment algorithms (guideline oriented) for referral to physicians during cases of concern. In this model, a physician is consulted when the physical therapists feel it is necessary; or when directly requested by a patient. Physician consult is not normally provided as an option for the control group, unless evidence exists within the examination to suggest the need from a mutually agreed upon examination scheme including identification of red flags between the PT and physician. In the current model, because most of patients seen are diagnosed with non-specific LBP and do not require imaging or prescriptive medications, a majority are treated actively by the physical therapists-only during the initial visit.
16154695|NCT01744002|Other|Shoulder treatment and neck mobilization|This group will receive shoulder treatment with an emphasis on 1) range of motion activities, 2) joint mobilization, 3) rotator cuff strengthening and 4) a home exercise program that consists of shoulder strengthening exercises; and joint mobilizations to the neck.
16154696|NCT01744002|Other|Control|This group will receive shoulder treatment with an emphasis on 1) range of motion activities, 2) joint mobilization, 3) rotator cuff strengthening and 4) a home exercise program that consists of shoulder strengthening exercises.
16154697|NCT01743989|Drug|Nilotinib|Participants received a daily oral nilotinib dose of 300 mg BID, given as two 150 mg capsules BID.
16154698|NCT01743976|Drug|Donepezil|donepezil 5 mg once daily for 6 weeks
16154699|NCT01743976|Drug|Placebo|placebo or sugar pill will be taken once daily for 6 weeks
16154700|NCT01743963|Behavioral|Decision support|Clinical pharmacists mediated computerized decision support
16154701|NCT01743963|Behavioral|Usual Care|clinicians typical apporach for GID monitering
16154702|NCT01743950|Drug|Bevacizumab|10mg/kg every 2weeks.
16154703|NCT01743950|Radiation|PRDR|Daily dose of 2.0gy delivered in .2gy pulses for a total of 54gy over 5.5 weeks and 27 fractions. In the rare instance of the presence of extensive disease requiring essentially whole brain radiation, a total daily dose of 1.8 Gy delivered in .2 Gy pulses for 23 fractions to a total dose of 41.4 Gy will be utilized.
16154704|NCT01743937|Procedure|Coronary occlusion with balloon inflation|
16154705|NCT01743924|Other|raw broccoli|To eat this plant material
16154706|NCT01743911|Other|sugar pill|Sugar pills: 20mg orally, once a day for 2 weeks
16154707|NCT01743911|Drug|Tadalafil|Tadalafil pills: 20mg orally, once a day for 2 weeks.
16154708|NCT01743898|Drug|Rivaroxaban|Patients will continue on their Rivaroxaban dose as previously prescribed by their individual physician. No dose adjustments will be made for the purpose of this study.
16154709|NCT01743898|Other|no anticoagulation|
16154710|NCT01743885|Drug|Acebutolol|10 mg/kg/jour in 2 doses during 90 days after gradual increase of doses in the first week
16154711|NCT01743885|Drug|Propanolol|3 mg/kg/jour in 3 doses during 90 days after gradual increase of doses in the first week
16154712|NCT01743872|Procedure|iOCT|"Arterial access will performed by the operating surgeon. An aortic and infrainguinal angiogram using the standard method of intravenous iodinated contrast under digital subtraction fluoroscopy will be conducted in the usual manner according to the vascular surgeon. A 54 mm section of Superficial Femoral Artery will be chosen for study imaging. An intervention sheath or injection catheter will be placed just proximal to the area of interest. An 0.014 wire will be passed distal to the area of interest. The patient will then undergo OCT of this 54mm section with each of the three mediums below using a continuous flushing method through injection catheter. All OCT imaging will be collected at a rate of 25mm/sec. In the event of a subsequent procedure, OCT imaging will again be performed."
16154713|NCT01743859|Drug|Azacitidine|Enrolled patients will receive 75 mg/m2 of azacitidine subcutaneously (SC) or intravenously (IV) on days 1-7 alone.
16154714|NCT01743859|Drug|Lenalidomide|Beginning on day 8, patients will receive 50 mg of lenalidomide PO, and will take this daily from day 8 through 28.
16154715|NCT01743859|Other|Off Therapy|2 weeks off therapy, then begin sequence again for 12 weeks.
16154716|NCT01743833|Other|Thoracic High Velocity, Low Amplitude Thrust Maneuver (HVLATM)|
16154717|NCT01743833|Other|Scapular High Velocity, Low Amplitude Thrust Maneuver|
16154718|NCT01743820|Drug|dihydroartemisinin-piperaquine|
16154719|NCT01743820|Drug|0.125 mg/kg Primaquine|
16154720|NCT01743820|Drug|0.5 mg/kg Primaquine|
16154721|NCT01743820|Drug|0.25 mg/kg Primaquine|
16154722|NCT01743820|Drug|0.0625 mg/kg Primaquine|
16154723|NCT01743807|Drug|GNKG168|GNKG168 will be given intravenously over 1 hour on days 1 through 5 followed by 9 days of rest. Dose will be assigned at study entry.
16154771|NCT01743378|Procedure|TAP Block Ropivacaine 0,75 %|
16154724|NCT01743794|Drug|Ropivacaine|wound infusion, 0.2%, bolus 10mL followed by 8 mL/h infusion
16154725|NCT01743794|Drug|Saline solution 0.9%|wound infusion, 0.9%, bolus 10mL followed by 8 mL/h
16154726|NCT01743781|Behavioral|video|view a 10-minute informational video about comprehensive eye examination
16154727|NCT01743768|Drug|SB010|Treatment group (n=19), receiving the active drug substance.
16154728|NCT01743768|Drug|Placebo|Treatment group (n=19), receiving placebo.
16154729|NCT01743755|Drug|Dexamethasone|Dexamethasone tablet 6 mg, once daily for four consecutive days
16154730|NCT01743755|Drug|Placebo|Placebo tablet, once daily for four consecutive days
16154731|NCT01743742|Drug|Vitamin E, Vitamin C|
16154732|NCT01743729|Drug|Lifitegrast|Lifitegrast Ophthalmic Solution 5.0%
16154733|NCT01743729|Drug|Placebo|Placebo for Lifitegrast Ophthalmic Solution 5.0%
16154734|NCT01743703|Other|diagnostic whole body MRI|diagnostic whole body MRI, both STIR and diffusion weighted
16154735|NCT01743690|Biological|Probiotic lactobacilli reuteri|
16154736|NCT01743690|Drug|Nystatin|
16154737|NCT01743690|Drug|fluocinolone|
16154738|NCT01743677|Drug|CP-690,550|Single dose 100 mg (5 x 20 mg tablets)
16154739|NCT01743677|Drug|Placebo|Single dose placebo tablets (5 tablets)
16154740|NCT01743677|Drug|Moxifloxacin|Single dose Avelox 400 mg tablet
16154741|NCT01743664|Behavioral|EMDR|Patients in the experimental group will undergo 10 weekly sessions of 60 minutes each with EMDR following Shapiro's protocol for traumatic events
16154742|NCT01743664|Behavioral|Relaxation|The patients in the control group will undergo 10 weekly relaxation sessions that include diaphragmatic breathing, progressive muscle relaxation, visualization and rapid relaxation.
16154743|NCT01743651|Drug|arbaclofen|10 mg, 15 mg or 20 mg arbaclofen ER tablets administered orally 2 times per day
16154744|NCT01743651|Drug|baclofen|20 mg, 30 mg or 40 mg baclofen administered orally 4 times per day
16154745|NCT01743651|Drug|Placebo|arbaclofen image matched placebo tablets administered orally 2 times/day or baclofen image matched placebo capsules administered orally 4 times/day
16154746|NCT01743638|Procedure|MR-Guided Laser Ablation|
16154747|NCT01743625|Drug|COV155|COV155 tablets
16154748|NCT01743625|Drug|placebo|
16154749|NCT01743612|Procedure|laser speckle contrast imaging|blood flow recording during 30 minutes after 2 post-occlusive hyperaemia of 5 minutes separated by 30 minutes.
16154750|NCT01743612|Procedure|Cooling|blood flow of the hand recording during 30 minutes in a cooling-box
16154751|NCT01743586|Other|Chest physiotherapy education intervention|breathing exercise (diaphragmatic breathing and pursed-lip breathing cough training secretion mobilization (percussion and vibration) progressive muscle relaxation pacing and energy-saving techniques
16154752|NCT01743573|Other|yoga|
16154753|NCT01743560|Drug|RAD001|All postmenopausal women with oestrogen receptor positive locally advanced or metastatic breast cancer were treated with oral tablet RAD001 at a dose of 10mg daily and oral tablet exemestane 25mg daily. The study treatment for an individual patient was to begin on Study Day 1 and continue until the last patient enrolled completed the study at day 336 or until disease progression; unacceptable toxicity, death or early discontinuation from the study for any other reason, whichever occurs first.
16154754|NCT01743560|Drug|Exemestane|All postmenopausal women with oestrogen receptor positive locally advanced or metastatic breast cancer were to be treated with oral tablet RAD001 at a dose of 10mg daily and oral tablet exemestane 25mg daily. The study treatment for an individual patient was to begin on Study Day 1 and continue until the last patient enrolled completed the study at day 336 or until disease progression; unacceptable toxicity, death or early discontinuation from the study for any other reason, whichever occurs first.
16154755|NCT01743547|Other|Yoga|Patients will be randomized to Yoga or control group. Those in Yoga intervention will receive 8 weekly yoga sessions.
16154756|NCT01743521|Drug|TPV/PEG-IFN/RBV|"Drug Telaprevir (TPV): dosed 1125mg twice daily (given as three 375 mg film-coated tablets) orally, except in the situation where a patient is on efavirenz in which case the dose of telaprevir will be 1125mg three times daily.
~Drug Ribavirin (RBV): 1000mg or 1200mg p.o daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg).
~Drug PEG-IFN (other name: Pegasys): 180mcg in 0.5ml (pre-filled syringes) administered subcutaneously once weekly."
16154757|NCT01743508|Procedure|Misoprostol treatment by midwife|Misoprostol treatment by midwife
16154758|NCT01743495|Behavioral|10 home-based functional services sessions over 4 months.|The program consists of up to 10 home-based functional services sessions over 4 months.
16154759|NCT01743482|Drug|Pazopanib|
16154760|NCT01743469|Drug|Tasquinimod|1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
16154761|NCT01743469|Drug|Tasquinimod|1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
16154762|NCT01743469|Drug|Tasquinimod|1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
16154763|NCT01743469|Drug|Tasquinimod|1 capsule: initially at 0.5 mg/day, increasing to 1 mg/day, maintaining 0.5 mg/day or decreasing to 0.25 mg/day after at least 2 weeks.
16154764|NCT01743456|Other|Targeted intra-operative depth of anaesthesia|The intervention group receives isoflurane at a concentration that results in a BIS value between 40-60 intra-operatively.
16154765|NCT01743443|Other|Cochet-Bonnet esthesiometer central corneal sensitivity|Using the Cochet-Bonnet esthesiometer central corneal sensitivity was measured preoperatively, after 7 days, and once a month after surgery until recovery of the baseline preoperative level. Normal levels of central corneal sensitivity were considered above 40mm.
16154766|NCT01743430|Other|telerehabilitation|telerehabilitation for 4 weeks, 2 sessions per week and 30 to 50 minutes per session
16154767|NCT01743417|Behavioral|Computerised cognitive rehabilitation training|24 sessions of computerised bran training will be provided for 8 weeks (+/-2) with about 3 sessions per week to the intervention arm and active control arms. The program will be programmed to increases in difficulty for the intervention arm. In the active control arms, the difficulty level will not change.
16154768|NCT01743404|Dietary Supplement|Inflaminat|
16154769|NCT01743404|Drug|Placebo|Sugar pill manufactured to mimic Inflaminat 500 mg tablet
16154774|NCT01743339|Behavioral|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy for Insomnia(4 individual therapy sessions over 5 weeks) will consist of a standard, structured, multi-component CBT intervention (sleep education, sleep hygiene, sleep restriction, stimulus control, cognitive therapy, and relapse prevention) Cognitive Processing Therapy will consist of a standard, structured 12-session protocol (PTSD education, exploring personal impact of trauma, experiencing emotions related to thoughts of trauma, cognitive therapy, and applying healthy thoughts and behaviors) delivered in individual weekly sessions
16154775|NCT01743339|Behavioral|Control|Cognitive Processing Therapy will consist of a standard, structured 12-session protocol (PTSD education, exploring personal impact of trauma, experiencing emotions related to thoughts of trauma, cognitive therapy, and applying healthy thoughts and behaviors) delivered in individual weekly sessions.
16154776|NCT01743326|Procedure|Radio Frequency Denervation|
16154777|NCT01743326|Procedure|Local Anesthesia|
16154778|NCT01743300|Drug|Sunitinib|All patients receive once daily 50 mg sunitinib for 6 weeks in the registered schedule of 4 weeks on two weeks off treatment.
16154779|NCT01743300|Drug|Midazolam|All patients receive three times midazolam 7,5 mg on PK day 1,2, and 3 e.g. between day 14-21 of treatment, on day 28 of treatment and on day 42 of treatment.
16154780|NCT01743300|Other|Orange juice|The orange juice will be administered 3 times per day for 1 period of 3 days in the 4th week of treatment with sunitinib, just before PK day 2 on day 28 of treatment
16154781|NCT01743300|Other|Grapefruit juice|The grapefruit juice will be administered 3 times per day for 1 period of 3 days in the 4th week of treatment with sunitinib, just before PK day 2 on day 28 of treatment
16154782|NCT01743287|Drug|Imotun capsule|Imotun capsule: Avocado-Soya Unsaponifiables 300.03mg/Cap, per oral, a capsule once a day during for 24 weeks
16154783|NCT01743287|Drug|Imotun capsule placebo|Imotun capsule placebo: per oral, a capsule a day during 24 weeks
16154784|NCT01743274|Procedure|OCT|"Optical Coherence Tomography (OCT) is a recent imaging modality that yields cross-sectional images with a resolution 10 times greater than that of intravascular ultrasound (IVUS). OCT uses a near-infra-red light source to obtain images of the interior walls of the coronary arteries and is increasingly used to evaluate vulnerable atherosclerotic plaques and assess placement and response to stenting.
~OCT images are acquired by automated pullback over 2 to 3 seconds of the light source that yields a helicoidal image of a longitudinal segment of 50 mm. Intravascular imaging is obtained by injecting contrast medium or saline solution."
16154785|NCT01743261|Other|multidisciplinary intervention|Multidisciplinary intervention Instruments of governance are the diagnostic-therapeutic rehabilitation pathways (DTRP), the Quality system and product standards; Medical care process with result-oriented autonomy Technology support of vital signs.
16154786|NCT01743261|Other|usual care|"specific pathology. access is determined by clinical stability. the instruments of governance are guidelines and consensus and the rehabilitation programme is focused on functional and cognitive areas.
~the medical care process is governed by hierarchy. The technology in this model is limited to a specific specialty"
16154787|NCT01743235|Drug|Placebo|Solid Oral Dosage. Maximum every other day (on an as needed basis)
16154788|NCT01743235|Drug|Testosterone|Solid Oral Dosage. Maximum every other day (on an as needed basis)
16154789|NCT01743235|Drug|Buspirone hydrochloride|Solid Oral Dosage. Maximum every other day (on an as needed basis)
16154790|NCT01743222|Genetic|eASC|"First cohort: Intra lymph node injection of 2.5 millions of eASCs suspended in 0.5 ml of HypoThermosol per lymph node, total dose 5 millions of cells.
~Second cohort: Intra lymph node injection of 5 millions of eASCs suspended in 0.25 ml of HypoThermosol per lymph node, total dose 10 millions of cells."
16154791|NCT01743222|Drug|Placebo|"First cohort (2 volunteers): injection of 0.25 ml of HypoThermosol (HTS) per lymph node
~Second cohort (2 volunteers): injection of 0.5 ml of HypoThermosol (HTS) per lymph node"
16154792|NCT01743183|Device|Threshold|The load adjustment was done weekly by a single examiner.
16154793|NCT01743170|Other|Telemonitoring of self-measured blood pressure|In the intervention group, doctors receive weekly reports via telemonitoring on the self-measured blood pressure
16154794|NCT01743157|Drug|Biochemo + bevacizumab then ipilimumab|Bevacizumab 7.5mg/kg week 1,repeat weeks 4,7,10 (cycles 2, 3, & 4)
16154795|NCT01743144|Drug|Magnesium Sulfate|Magnesium sulphate (MgSO4) 10% solution is going to be used, an initial MgSO4 bolus dose 30mg/kg (i.e. 0.3mL/kg) will be infused over 10 minutes after endotracheal intubation. This will be followed by a continuous infusion of 10 mg/kg/hr (i.e. 0.1 ml/kg/h). Infusion will continue during the entire intraoperative course and will be terminated with the discontinuation of sevoflurane
16154796|NCT01743144|Drug|normal saline|normal saline (NaCl 9%) is going to be used, an initial normal saline bolus dose 0.3ml/kg will be infused over 10 minutes after endotracheal intubation. This will be followed by a continuous normal saline infusion of 0.1 ml/kg/h. Infusion will continue during the entire intraoperative course and will be terminated with the discontinuation of sevoflurane
16154797|NCT01743131|Drug|Abatacept|Arm B-investigational prophylaxis with abatacept, a calcineurin inhibitor and methotrexate
16154798|NCT01743131|Drug|placebo|
16154799|NCT01743118|Drug|SPS4251 Ointment|Approximately 200 µl of each TREATMENT will be topically applied per test field (1.1 cm2) once daily during a 12-day treatment period (10 treatments)
16154800|NCT01743118|Drug|Placebo|Approximately 200 µl of each TREATMENT will be topically applied per test field (1.1 cm2) once daily during a 12-day treatment period (10 treatments)
16154801|NCT01743118|Drug|Daivonex® ointment|Approximately 200 µl of each TREATMENT will be topically applied per test field (1.1 cm2) once daily during a 12-day treatment period (10 treatments).
16154802|NCT01743105|Procedure|Diaphragm excursion measures 1|A first diaphragm ultrasound study will be carried out by investigator 1. A Vivid S6 GE Ultrasound will be used, with a phased array cardiac probe.
16154803|NCT01743105|Procedure|Diaphragm excursion measures 2|A second diaphragm ultrasound study will be carried out immediately after Ultrasound 1, and by investigator 2. The results are blinded between investigators. A Vivid S6 GE Ultrasound will be used, with a phased array cardiac probe.
16154804|NCT01743092|Behavioral|Webinar|Some clients will receive a webinar as part of their treatment.
16154805|NCT01743092|Behavioral|Tutuorial workbook|A work book about their addiciton
16154806|NCT01743079|Drug|Telbivudine|LdT 600mg QD
16154807|NCT01743079|Drug|Lamivudine|LAM 100mg QD
16154808|NCT01743066|Dietary Supplement|Vitamin E|vitamin E (200 IU, caplet) daily orally for 20 weeks
16154809|NCT01743053|Device|Standard Care plus ReCell|
16154810|NCT01743053|Other|Standard Care|
16154811|NCT01743040|Diagnostic Test|CADence|"Patients with chest pain and two or more coronary risk factors and who were already indicated for nuclear stress test were enrolled in the study. The CADence was performed prior to nuclear stress test. Patients underwent standard angiogram based upon normal clinical judgement. In all other patients a CT angiogram followed.
~CADence is a handheld equipped with acoustic sensor technology, a patient booklet, remote algorithm and final report."
16154812|NCT01743027|Drug|AL-4943A ophthalmic solution|
16154813|NCT01743027|Drug|Olopatadine hydrochloride ophthalmic solution, 0.2%|
16154814|NCT01743027|Drug|Olopatadine hydrochloride ophthalmic solution, 0.1%|
16154815|NCT01743027|Drug|AL-4943A ophthalmic solution vehicle|
16154816|NCT01743014|Drug|Ramipril|Patients will receive 10 mg ramipril throughout the study. Each dose will be taken orally once daily. The duration of treatment with ramipril is 26 weeks
16154817|NCT01743014|Drug|Clopidogrel|12 weeks treatment with ramipril 10 mg and clopidogrel 75 mg once daily followed by a 2 week wash out period for clopidogrel and subsequently additional 12 weeks treatment wit both drugs after cross over.
16154818|NCT01743001|Drug|Macitentan 10 mg|Macitentan 10 mg oral tablet once daily
16154819|NCT01743001|Drug|Placebo|Macitentan-matching placebo oral tablet once daily
16154820|NCT01742988|Drug|fimepinostat|
16154821|NCT01742988|Drug|Rituximab|
16154822|NCT01742988|Drug|venetoclax|
16154823|NCT01742975|Device|IFABOND (TM)|The synthetic adhesive solution Ifabond, will be applied at the end of conventional breast cancer surgery for arm A patients
16154824|NCT01742962|Procedure|Radical prostatectomy for prostate cancer|Prior treatment with open or robot assisted laparoscopic prostatectomy.
16154825|NCT01742949|Device|Heated humidification (ThermoSmart)|Heated Humidification (ThermoSmart) Turned On
16154826|NCT01742949|Device|No Humidification|Heated Humidification (ThermoSmart) Turn Off
16154827|NCT01742936|Device|CoaguChek|Hand held coagulation monitor.
16154828|NCT01742936|Other|Hospital Laboratory|Coagulation testing done by hospital laboratory.
16154829|NCT01742923|Behavioral|Complex tailored intervention|
16154830|NCT01742923|Behavioral|Usual care|
16154831|NCT01742910|Procedure|intraocular lens implantation|
16154832|NCT01742897|Drug|TTS-fentanyl|
16154833|NCT01742884|Other|Thealoz|Instillation of 1 drop of Thealoz
16154834|NCT01742884|Other|Vehicle|1 drop of the vehicle will be instillated in the eye
16154835|NCT01742845|Other|Ultrasound-guided administration of ropivacaine 4.75 mg/ml|
16154836|NCT01742845|Other|landmark based superfical ropivacaine 4.75 mg/ml injection|
16154837|NCT01742832|Drug|Vilazodone|A fixed dose titration (with doses ranging from 10mg to 40mg/day) will be used. Subjects will take 10mg/day for 1 week, 20mg/day for 1 week and then 40mg/day.
16154838|NCT01742832|Drug|Citalopram|For those assigned to citalopram, the dose of citalopram will be maximized to 40mg/day. For those assigned to vilazodone, their citalopram dose will be maintained at 20mg/day for 1 week, then reduced to 10mg/day for 1 week, then switched to vilazodone 10mg/day.
16154839|NCT01742806|Device|bio-absorbable felt(NEOVEIL®)|To cover bio-absorbable felt over the lymphadenectomy area (hepatoduodenal ligament, #5 and 12/gastroduodenal artery, #6/ pancreas head /suprapancreatic area, #7,8 and 9)
16154840|NCT01742793|Drug|lenalidomide (Revlimid) and romidepsin (Istodax)|
16154841|NCT01742780|Procedure|Proximal Humerus Intraosseous Vascular Access|EZ-IO Intraosseous Vascular Access System
16154842|NCT01742767|Drug|Cisplatinum|
16154843|NCT01742767|Drug|Pemetrexed|
16154844|NCT01742754|Other|Fecal Microbiota Transplantation|Fecal microbiota transplantation by colonoscopic administration of 300cc of fecal slurry from healthy donor to the right colon.
16154845|NCT01742741|Device|Diabetes Assistant (DiAs)|A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night.
16154846|NCT01742715|Other|PEEP by Best oxygenation|"Set PEEP at 25 cmH2O with fixed driving pressure that will result in delivery of a fixed Tidal Volume (TV) of 6ml/kg (IBW). FiO2 is set to 60%.
~Then decrease PEEP in steps of 4 cmH2O every 10 min until PEEP of 5 cm H2O is reached. In each step static compliance of respiratory system and lung compliance will be measured along with ABGs, and hemodynamic parameters such as cardiac output and mixed venous O2 saturation. Best or optimal PEEP will be defined as the PEEP below which PaO2 /FIO2 falls by at least 20%. If at least 20% PaO2 /FIO2 decrement is not obtained, then PEEP that will result in the highest PaO2 will be selected."
16154847|NCT01742715|Other|PEEP by Best Compliance|"In this group assessment begins with measuring intrinsic PEEP by an expiratory hold. Thereafter, plateau pressures will be recorded after a 0.5-sec inspiratory pause.
~Applied PEEP will be increased by steps of 4 cm H2O, after each incremental step the patient will be observed for 10 minutes to allow for lung unit recruitment and equilibration. Plateau pressure will be measured after each incremental step of PEEP. Applied PEEP will be increased sequentially by 4 cm H2O increments until peak inspiratory pressure of 50 cm H2O, or plateau pressure of 40 cm H2O reached, or hypotension or decrease of 20% in cardiac output is observed."
16154848|NCT01742715|Other|PEEP by Esophageal pressure|Upon patient recruitment Esophageal balloon will be inserted and esophageal / pleural pressure will be measured. Thereafter, Inspiratory pressures and PEEP will be adjusted according to well established criteria. Inspiratory pressure and PEEP will be adjusted to achieve the best lung compliance possible while not exceeding transpulmonary end Inspiratory pressure of 25 to 30 cm H2O, and at the same time maintaining a positive transpulmonary end expiratory pressure of not more than 5 cm H2O.
16154849|NCT01742702|Drug|Nitroglycerin 0.25 mg (single dose, no longer given since January 2017)|From the beginning of the study until the end of year 2016 a single dose of sublingual nitroglycerin was given to examine the associated acute haemodynamic effects (recordings completed).
16154938|NCT01742117|Genetic|Retrospective Genotype testing|Mayo Clinic will use ABI TaqMan assay of three variants in the CYP2C10 gene: *2, *3 and *17
16154850|NCT01742702|Drug|Salbutamol 400 µg (single dose, no longer given since January 2017)|From the beginning of the study until the end of year 2016 a 400 µg dose of inhaled salbutamol was given to examine the associated acute haemodynamic effects (recordings completed).
16154851|NCT01742702|Drug|L-arginine (10 min infusion, no longer given since January 2017)|From the beginning of the study until the end of year 2016 L-arginine infusion 10 mg/kg/min could be given for 10 minutes to examine acute haemodynamic effects (recordings completed).
16154852|NCT01742702|Dietary Supplement|Liquorice (2 weeks, glycyrrhizin 290-370 mg daily, no longer given since 2012)|Daily liquorice intake (daily glycyrrhizin dose 290-370 mg) for two weeks, measurements before and after intervention (recordings completed).
16154853|NCT01742702|Dietary Supplement|Small milk casein-derived polypeptides (12 weeks daily, recordings completed 2011)|Daily intake of yoghurt containing small milk casein-derived polypeptides (12 weeks) and placebo yoghurt (12 weeks), measurements before and after intervention (recordings completed 2011).
16154854|NCT01742702|Drug|Bisoprolol (5 mg daily for 3 weeks, recordings completed 2011)|Bisoprolol 5 mg daily for 3 weeks and placebo tablet daily for 3 weeks, double-blind, randomized, placebo-controlled cross-over protocol. Measurements before and after interventions (recordings completed 2011).
16154855|NCT01742689|Drug|Desmopressin intranasal spray|10 microgram per puff, 40 microgram is Descript
16154856|NCT01742689|Drug|Placebo intranasal spray|Saline spray identical to desmopressin, administered as 4 sprays
16154857|NCT01742689|Drug|Indomethacin suppository|Indomethacin suppository 100 milligram single dose
16154858|NCT01742676|Drug|ADVAGRAF|oral
16154859|NCT01742676|Drug|PROGRAF|oral
16154860|NCT01742663|Drug|Diclofenac Sodium Gel 3%|Diclofenac Sodium Gel 3% (Taro Pharmaceuticals Inc.) applied twice daily for 60 days.
16154861|NCT01742663|Drug|Solaraze® (diclofenac sodium) Gel 3%|Solaraze® (diclofenac sodium) Gel 3% (Fougera Pharms)applied twice daily for 60 days.
16154862|NCT01742663|Drug|Vehicle Topical Gel|Vehicle Topical Gel (Taro Pharmaceuticals Inc.) applied twice daily for 60 days.
16154863|NCT01742650|Procedure|Screw fixation|3,5mm fully threaded cortical screw transfixation of syndesmosis
16154864|NCT01742650|Procedure|TightRope|TightRope transfixation of syndesmosis
16154865|NCT01742637|Drug|Adapalene and Benzoyl Peroxide Gel 0.1%/2.5%|Adapalene and Benzoyl Peroxide Gel 0.1%/2.5% (Taro Pharmaceuticals Inc.)applied topically once daily for 84 consecutive days.
16154866|NCT01742637|Drug|Epiduo® Gel|Epiduo® (Adapalene and Benzoyl Peroxide Gel 0.1%/2.5%) (Galderma Laboratories, L.P.)applied topically once daily for 84 consecutive days.
16154867|NCT01742637|Drug|Placebo|Placebo (vehicle of test product) (Taro Pharmaceuticals Inc.)applied topically once daily for 84 consecutive days.
16154868|NCT01742624|Drug|Advagraf|oral
16154869|NCT01742624|Drug|Prograf|oral
16154870|NCT01742624|Drug|Corticosteroid|oral
16154871|NCT01742624|Drug|Mycophenolate mofetil|oral
16154872|NCT01742611|Drug|ASP1585|oral
16154873|NCT01742598|Device|Portico Transapical Aortic Valve System|
16154874|NCT01742585|Drug|ASP1585|oral
16154875|NCT01742585|Drug|placebo|oral
16154876|NCT01742572|Behavioral|Diet|Change in dietary intake
16154877|NCT01742559|Procedure|Anterior middle superior alveolar|The AMSA technique is performed according to Friedman & Hochman (1997). The needle is introduced with the bevel towards the palate tissue with a 45 ° angle and axially rotated (45° clockwise/45° counterclockwise) and 0.6 ml of the anesthetic was slowly infiltrated for 1 minute. In the control group a supraperiosteal infiltration (infiltrative) at the bottom of the vestibule is performed for one minute and 1.8 ml of anesthetic solution is administrated. This amount of anesthetic is divided into doses of 0.6 ml infiltrated, respectively, in the region of the incisors, canines and premolars. After the anesthetic technique, two minutes would be expected for the beginning of the periodontal procedure.
16154878|NCT01742559|Procedure|Supraperiosteal technique|The supraperiosteal technique is performed at the bottom of the vestibule for one minute and 1.8 ml of anesthetic solution is administrated. This amount of anesthetic is divided into doses of 0.6 ml infiltrated, respectively, in the region of the incisors, canines and premolars. After the anesthetic technique, two minutes would be expected for the beginning of the scaling and root planning procedure.
16154879|NCT01742546|Device|Therapeutic ultrasound combine TENS|"Use ultrasound treatment parameters as continuous mode, 1 MHz in frequency and 1 w/cm2 for intensity and circular stroking of sound head over affected upper trapezius muscle throughout treatment period. For simultaneous TENS parameters as pulse frequency 100-150 pps, pulse duration 50- 80 µs and adjust amplitude as produce tingling for 10 minutes. The skin electrode should be placed near the active trigger in area of trapezius muscle. And the control group received sham TENS by turn-off electrical current.
~The therapeutic ultrasound machine in this study was Sonopuls 492 TM (Enraf-Nonius)."
16154880|NCT01742533|Biological|human umbilical cord mesenchymal stem cells|
16154881|NCT01742533|Biological|hUCMSCs and hCBMNCs|
16154882|NCT01742533|Biological|human cord blood mononuclear cells|
16154883|NCT01742533|Drug|Hormone Replacement Therapy|
16154884|NCT01742520|Drug|multiple doses of sucrose|unlimited number of doses par day- current status in our NICU
16154885|NCT01742520|Drug|Formula or breast milk|1-3 minutes prior to every painful procedure, breast milk or formula 0.5-1 ml will be given on the anterior part of the tongue
16154886|NCT01742507|Device|Resolute Integrity Stent|Resolute Integrity Stent
16154887|NCT01742507|Device|Biomatrix stent|Biomatrix stent
16154888|NCT01742494|Procedure|Water-jet POEM|Water-jet assisted POEM procedure was performed
16154889|NCT01742494|Procedure|Conventional POEM|POEM were performed by the use of conventional technique using injection and triangle tip knife.
16154890|NCT01742481|Behavioral|Education and empowerment|Three group sessions delivered once per week over three weeks. Education on late effects of treatment, survivorship care, how to request medical records, and role playing on how to talk to a provider about childhood cancer health risks
16154891|NCT01742468|Dietary Supplement|long-chain n-3 PUFA|Dietary supplement: n-3 LC-PUFA = Microalgae oil (Schizochytrium sp., Maris DHA oil, no. 3790, IOI, Hamburg, Germany (rich in docosahexaenoic acid (DHA)); Dosage: 8 g oil per day = 2.11 g DHA per day; Dosage form: included in 60 g sausage, 8 g tomato spread, 30 g milk powder
16155147|NCT01740544|Other|Cathodal tDCS|Cathodal tDCS applied over the right PPC
16154892|NCT01742468|Dietary Supplement|sunflower oil|Dietary supplement: sunflower oil Name: sunflower oil (PPM, Magdeburg, Germany); Dosage: 8 g per day; Dosage form: 8g oil was included in 60 g sausage, 8 g tomato spread, 30 g milk powder
16154893|NCT01742429|Drug|Proton pump inhibitor|
16154894|NCT01742429|Drug|Bismuth subsalicylate|
16154895|NCT01742429|Drug|Metronidazole|antibiotic
16154896|NCT01742429|Drug|Tetracycline|antibiotic
16154897|NCT01742429|Drug|Amoxicillin|antibiotic
16154898|NCT01742429|Drug|Levofloxacin|antibiotic
16154899|NCT01742416|Procedure|Ultrasound|Arterial cannulation facilitated by ultrasound.
16154900|NCT01742416|Procedure|Palpation Method|Arterial cannulation by palpation method.
16154901|NCT01742403|Radiation|R/T gating kV intrafraction monitoring|This is a Phase I Pilot study to assess the feasibility of implementing prostate radiotherapy gating using kV intrafraction monitoring.
16154902|NCT01742390|Drug|Aripiprazole|Plateau switch to aripiprazole (ARI) from risperidone (RIS) or paliperidone (PALI)
16154903|NCT01742390|Drug|risperidone or paliperidone|
16154904|NCT01742377|Procedure|Patients with GerdQ positive|Patients done GerdQ questionnaire, then undergone EGD. The distal esophagus was examined by HD and followed by SE with a preset TE mode for esophagus ( TE-e mode ). All patients had pH monitoring study within 1 week after the endoscopy.
16154905|NCT01742377|Procedure|Patients with GerdQ negative|Patients done GerdQ questionnaire, then undergone EGD. The distal esophagus was examined by HD and followed by SE with a preset TE mode for esophagus ( TE-e mode ). All patients had pH monitoring study within 1 week after the endoscopy.
16154906|NCT01742377|Procedure|Normal volunteers|Normal volunteers undergone EGD.The distal esophagus was examined by HD and followed by SE with a preset TE mode for esophagus ( TE-e mode ).
16154907|NCT01742364|Device|Bioject ID Pen|Participants in this arm will receive a standard dose of BCG via the Bioject ID needle-free jet injector device (investigational administration technique).
16154908|NCT01742364|Device|Needle and syringe|Participants in this arm will receive a standard dose of BCG via syringe and needle by the Mantoux technique (standard of care administration technique).
16154909|NCT01742351|Behavioral|Guided internet-based cognitive behavior therapy|
16154910|NCT01742338|Drug|Low Dose Corticosteroids|
16154911|NCT01742338|Drug|High Dose Corticosteroids|
16154912|NCT01742325|Behavioral|walking|two 20-minute sessions of walking around the nurse's station daily, five days a cycle
16154913|NCT01742312|Radiation|DEXA scan|all patients will undertake a full body DEXA scan before and after chemotherapy
16154914|NCT01742312|Procedure|Muscle biopsy|All patients will have a muscle biopsy before and after chemotherapy
16154915|NCT01742312|Other|cardio-pulmonary exercise testing (CPEX)|patients will undertake exercise in the form of an exercise bike whilst having their cardiac and ventilatory performance analysed. This will take place before and after neoadjuvant chemotherapy
16154916|NCT01742299|Drug|imatinib mesylate|Imatinib will be provided as 100 mg and 400 mg tablets taken orally once daily unless other wise instructed by investigator
16154917|NCT01742286|Drug|Ceritinib|"LDK378 is a capsule taken by mouth, contents can be mixed with food for pediatric patients or mixed with water and given via nasogastric/gastric (NG/G) tube. For patients in fasted group: 1-2 tablespoons (15-30 mL) of an appropriate food such as apple sauce or non-fat yogurt and a glass of water were allowed.
~For patients in the fed cohort: LDK378 was taken with, or within 30 minutes after finishing a low-fat light snack containing 100-300 calories and 1.5-2 grams of fat."
16154918|NCT01742273|Drug|Vitamin K1|Vitamin K1 to slow vascular calcification
16154919|NCT01742260|Procedure|Repair of cranial defects by tissue engineering|Repair of defect using mesenchymal stromal cells seeded between moulded bioceramic plates
16154920|NCT01742247|Other|Physiogel|Application of moisturizer on laser-treated area
16154921|NCT01742247|Other|Moisturizer|Application of moisturizer on laser-treated area
16154922|NCT01742234|Procedure|Organ Donation|People in this study will donate either a lung or kidney
16154923|NCT01742221|Biological|HemaMax|single subcutaneous 12 microgram dose of HemaMax
16154924|NCT01742221|Drug|Placebo|single subcutaneous dose
16154925|NCT01742208|Drug|Sotagliflozin|Participants received sotagliflozin once daily for 29 days. Pioneer Group participants were to have completed dosing prior to any study drug administration in Expansion Groups.
16154926|NCT01742208|Drug|Placebo|Participants received placebo-matching sotagliflozin tablets once daily for 29 days.
16154927|NCT01742208|Drug|Sotagliflozin|Participants received sotagliflozin once daily for 29 days; pioneer participants completed dosing prior to dosing any other study participants.
16154928|NCT01742195|Procedure|Oral EBUS insertion|
16154929|NCT01742195|Procedure|Nasal EBUS insertion|
16154930|NCT01742182|Other|Light exposure|
16154931|NCT01742169|Behavioral|Outreach and Reminder Intervention|This intervention includes (1) phone calls and text messages to inform participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results.
16154932|NCT01742143|Behavioral|The Integrated Cancer Care Access Network (ICCAN)|"Patients will receive written materials on social and economic resources and services. Treatment Outcomes Survey at Intake, 3 mo, 6 mo, and 1 year.
~Chart review at 3 mo, 6 mo and 1 year, and as needed. Plus Initial needs assessment. Assistance with high priority social and economic needs.Monthly follow-up with ICCAN Access Facilitator to address ongoing needs in addition to as-needed assistance."
16154933|NCT01742143|Behavioral|Usual and Customary Group (U&C)|"Patients will receive written materials on social and economic resources and services. Treatment Outcomes Survey at Intake, 3 mo, 6 mo, and 1 year.
~Chart review at 3 mo, 6 mo and 1 year, and as needed."
16154934|NCT01742130|Drug|sodium bicarbonate solution|
16154935|NCT01742130|Drug|Isotonic saline|
16154936|NCT01742117|Drug|Clopidogrel|Subjects will receive Clopidogrel, one 75 mg tablet per day by mouth for one year.
16154937|NCT01742117|Drug|Ticagrelor|Subjects will receive Ticagrelor, one 90 mg tablet twice per day by mouth.
16154939|NCT01742117|Genetic|Prospective Genotype testing|Rapid turnaround Spartan^TM Bioscience in vitro diagnostic assay for analysis of three variants in the CYP2C19 gene: *2, *3 and *17
16154940|NCT01742117|Other|Smartphone|Subjects will use their own iOS or Android smartphones to complete surveys and activities which will collect data on outcomes since their PCI, which can be compared to outcomes collected through study coordinator phone calls.
16154941|NCT01742091|Drug|LY2541546 - SC|Administered SC
16154942|NCT01742091|Drug|LY2541546 - IV|Administered IV
16154943|NCT01742091|Drug|Placebo - SC|Administered SC
16154944|NCT01742091|Drug|Placebo - IV|Administered IV
16154945|NCT01742078|Drug|LY2541546 - IV|Administered IV
16154946|NCT01742078|Drug|LY2541546 - SC|Administered SC
16154947|NCT01742078|Drug|Placebo|Administered IV or SC
16154948|NCT01742065|Other|Auto Plus|Clinics randomized to the Auto-Plus arm will engage in all activities in the Auto arm (send an introductory letter to participants, then a FIT Kit, then a reminder letter encouraging the return of the FIT Kit) in addition to one other outreach effort.
16154949|NCT01742052|Drug|MT-1303-Low|
16154950|NCT01742052|Drug|MT-1303-Middle|
16154951|NCT01742052|Drug|MT-1303-High|
16154952|NCT01742052|Drug|Placebo|
16154953|NCT01742026|Procedure|Aspergillus PCR technique|Aspergillus DNA PCR technique
16154954|NCT01742026|Procedure|Aspergillus AGA technique|Aspergillus AGA technique
16154955|NCT01742013|Drug|GCJBP Laennec Inj.|Test drug
16154956|NCT01742013|Drug|Placebo|Comparator
16154957|NCT01742000|Dietary Supplement|Karinat|
16154958|NCT01742000|Drug|Placebo|Sugar pill manufactured to mimic Karinat 500 mg tablet
16154959|NCT01741987|Other|Optive ®|instilation of 1 drop each eye 4 times per day
16154960|NCT01741987|Other|Fresh Tears ®|instilation of eye drop 4 times a day (qid)
16154961|NCT01741974|Dietary Supplement|Karinat|
16154962|NCT01741974|Drug|Placebo|Sugar pill manufactured to mimic Karinat 500 mg tablet
16154963|NCT01741961|Procedure|Ahmed valve|The flexible plate 7 (FP7) model (New World Medical) was implanted in patients with uncontrolled glaucoma.
16154964|NCT01741948|Drug|Hormonal contraceptive|"The study will follow patients who are first time users of HCs for a full year after initiation. Patients will be followed every 3 months via questionnaires, blood examinations, and gynecologic examination, in case dyspareunia evolves.
~First appointment (before initiation of HCs):
~Questionnaire FSFI (Female Sexual Function Index) questionnaire. Blood collection for hormones levels and extraction of mononuclear blood cells. A gynecologic exam intended to rule out existing problem which causing dyspareunia.
~3,6,9,and 12 months after initiation of HCs or anytime if a patient has dyspareunia:
~Questionnaire evaluating possible influence of HCs use (dyspareunia, lubrication and libido).
~FSFI questionnaire. Blood collection Gynecologic examination, designated to assess the cause of pain, including assessment of vestibular tenderness, muscle tightness and tenderness, pressure-pain thresholds measurement using vulvar algesiometer, pH measurement and vaginal swab for microscopy."
16154965|NCT01741922|Drug|ASA evening|Patients will be assigned to one of two parallel groups: Active comparator group during the first two months, namely, administration of acetylsalicylic acid 100 mg, in the morning and placebo in the evening and Experimental: Acetylsalicylic acid in the evening & placebo in the morning group, of administration of acetylsalicylic acid 100 mg in the evening, between (20.00 and 22.00 hours) and placebo in the morning. After that, patients will then undergo a washout period of 15 days to one month, during which all patients participating in the study will take their ASA doses during the daytime. After the washout period, participants will exchange groups
16154966|NCT01741922|Drug|Acetylsalicylic morning|Patients will be assigned in a blind and randomized way to one of two parallel groups: group I with the control treatment during the first two months, namely, administration of aspirin 100 mg, in the morning and placebo in the evening and group II initially receiving the intervention, of administration of aspirin 100 mg in the evening, between (20.00 and 22.00 hours) and placebo in the morning. After that, patients will then undergo a washout period of 15 days to one month, during which all patients participating in the study will take their ASA doses during the daytime. After the washout period, participants will exchange groups, i.e., patients randomly allocated to group I, so having taken aspirin in the morning and placebo in the evening, will now receive the intervention treatment, namely, administration of ASA in the evening and placebo in the morning for another two months and vice verse.
16154967|NCT01741922|Drug|Placebos morning|Patients will be assigned to one of two parallel groups: Active comparator group during the first two months, namely, administration of acetylsalicylic acid 100 mg, in the morning and placebo in the evening and Experimental: Acetylsalicylic acid in the evening & placebo in the morning group, of administration of acetylsalicylic acid 100 mg in the evening, between (20.00 and 22.00 hours) and placebo in the morning. After that, patients will then undergo a washout period of 15 days to one month, during which all patients participating in the study will take their ASA doses during the daytime. After the washout period, participants will exchange groups
16154968|NCT01741922|Drug|Placebo evening|Patients will be assigned to one of two parallel groups: Active comparator group during the first two months, namely, administration of acetylsalicylic acid 100 mg, in the morning and placebo in the evening and Experimental: Acetylsalicylic acid in the evening & placebo in the morning group, of administration of acetylsalicylic acid 100 mg in the evening, between (20.00 and 22.00 hours) and placebo in the morning. After that, patients will then undergo a washout period of 15 days to one month, during which all patients participating in the study will take their ASA doses during the daytime. After the washout period, participants will exchange groups
16154969|NCT01741909|Behavioral|education|after a baseline period, shorter intravenous treatment will be promoted by mail, posters, lectures, and pharmacy monitoring of treatment
16154970|NCT01741896|Procedure|Remote ischaemic preconditioning|The intervention is 4 cycles of upper limb ischaemic preconditioning. Each cycle consists of 5 minutes of blood pressure cuff induced ischaemia with 3 minutes of reperfusion. The ischaemic stimulus is induced by inflation of the cuff to 15mmHg above systolic pressure. The reperfusion stimulus is induced by cuff deflation. The RIPC stimulus is commenced at between 30-40 minutes prior to the administration of the IV contrast.
16155015|NCT01741532|Drug|Deferiprone oral solution|Deferiprone 80 mg/mL oral solution will be administered twice daily (b.i.d.) for 18 months. An initial dose of 5 mg/kg b.i.d. will be administered for 6 weeks. The dose will then be escalated to 10 mg/kg b.i.d. and finally to 15 mg/kg b.i.d.
16154971|NCT01741883|Behavioral|Side effect prevention training (SEPT)|SEPT is aimed to optimize patients' response expectations before the start of pharmacotherapy to prevent nocebo side effects during adjuvant endocrine treatment. SEPT is a three session cognitive-behavioural training. It includes psychoeducation about AET to provide a realistic view on AET, reduction of concerns about side effects and strengthening of necessity beliefs. Further contents are side effect management training and problem solving to enhance self-efficacy expectations about coping as well as imagination training to integrate positive aspects of medication into daily life.
16154972|NCT01741883|Behavioral|Attention Control group (ACG)|Supportive therapy includes common or unspecific factors such as elicitation of affect, a treatment context, empathy, reflective listening, and feeling understood. Supportive therapy thus provides a control condition for common factors and therapist attention, while lacking the specific intervention part. It will be delivered in the same frequency and at the same time points as the side effect prevention training (three individual sessions and three booster telephone calls).
16154973|NCT01741870|Dietary Supplement|Nutritional supplement|Subjects will receive 50 g/day of a soy protein-based nutritional supplement containing 9.5 g protein, 250 kcal energy and all essential micronutrients
16154974|NCT01741857|Biological|human umbilical cord derived MSC transplantation for SLE|
16154975|NCT01741844|Drug|No intervention|This is an observational study. Etravirine 200 mg will be adminstered twice daily in patients with Acquired Immune Deficiency Syndrome (AIDS).
16154976|NCT01741831|Drug|No intervention|This is an observational study. Darunavir will be administered as per the recommended doses and will be given orally for a period of 24 weeks. For treatment naive (never received treatment for AIDS) patients: Darunavir 800 mg will be adminstered along with ritonavir 100 mg once daily. For experienced patients: Darunavir 600 mg will be administered along with ritonavir 100 mg twice daily.
16154977|NCT01741818|Other|Measuring IVC collapsibility index by bedside ultrasonography|
16154978|NCT01741805|Other|Severe Asthma|Demographic data, Spirometry, induced sputum, IgE, Aspergillus specific IgE
16154979|NCT01741792|Drug|Blinatumomab|Administered by continuous intravenous infusion over 8 weeks in the first cycle and 4 weeks in the second cycle.
16154980|NCT01741779|Other|Whole Body Vibration Training|The Whole body vibration training intervention consists of lower-body exercise in a vibration platform 3 times per wk for 12 wk. The subjects will perform static and dynamic exercises for the legs on the vibration platform. Dynamic exercises will be performed with slow controlled movements starting from an upright position into a 60 degree knee flexion (squat) and maximal heel elevation (toestand). Static exercises will be performed without movement in the joint angles described previously. The training volume will increase progressively over the 12-week training period by increasing the intensity of vibration, duration of the exercise set (30-60 sec), number of sets per exercise, and total duration of the training session, and decreasing the duration of rest periods (30-60 sec).The intensity of vibration and amplitude will also be increased progressively (25-30 Hz of frequency and from low to high amplitude).
16154981|NCT01741779|Other|Hypocaloric diet|The hypocaloric diet intervention consists of 12 wk of the standard Nutrisystem foods plan complemented by fresh produce and dairy. Subjects consume breakfast, lunch, dinner, and one (women) or two (men) snacks per day.
16154982|NCT01741779|Other|Whole body vibration training & diet|Combination of whole body vibration training and hypocaloric diet
16154983|NCT01741766|Other|Stretching Training|The stretching training intervention consists of 38 whole-body stretching exercises, 3 times per week for 8 wk. Each stretch will be held in place for 30 seconds, with a 15 seconds of rest in between stretches.
16154984|NCT01741753|Drug|BKM120|Orally, every morning
16154985|NCT01741753|Drug|Abiraterone|Orally, 1000 mg, every morning
16154986|NCT01741753|Drug|Prednisone|Orally, 5 mg, every morning
16154987|NCT01741727|Drug|ABT-414|ABT-414 will be administered by intravenous infusion.
16154988|NCT01741714|Other|Sham chiropractic manipulative therapy|Sham manipulation
16154989|NCT01741714|Other|Chiropractic spinal manipulative therapy|Chiropractic spinal manipulative therapy
16154990|NCT01741701|Drug|Oxaloacetate (OAA)|
16154991|NCT01741701|Drug|Placebo|
16154992|NCT01741688|Biological|Tocilizumab|Tocilizumab was administered according to the local label.
16154993|NCT01741675|Behavioral|Questionnaire and monetary incentive|
16154994|NCT01741675|Behavioral|Questionnaire only|
16154995|NCT01741662|Other|neuropsychological evaluation|
16154996|NCT01741649|Procedure|Clorhexidine|Cleaning of the surgical site previous to the incision with a clorhexidine solution for five minutes.
16154997|NCT01741649|Procedure|Povidone|Cleaning of the surgical site previous to the incision with a povidone solution for five minutes.
16154998|NCT01741636|Other|educational intervention|Undergo Survivorship Care Planning
16154999|NCT01741636|Other|questionnaire administration|Ancillary studies
16155000|NCT01741636|Procedure|quality-of-life assessment|Ancillary studies
16155001|NCT01741623|Drug|Bisoprolol Fumarate Tablet 10 mg|10 mg tablet once a day
16155002|NCT01741623|Drug|Bisoprolol|10 mg tablet once a day
16155003|NCT01741610|Biological|Cristalloid and colloid coloading|Cristalloid coloading (Group L) Colloid coloading (Group C) No coloading (Group E)Placebo Comparator
16155004|NCT01741597|Procedure|dynamic contrast-enhanced magnetic resonance imaging|Undergo DCE-MRI
16155005|NCT01741597|Other|pharmacological study|Correlative studies
16155006|NCT01741597|Biological|tumor-homing peptide iRGD|Undergo tumor-homing peptide iRGD DCE-MRI
16155007|NCT01741584|Behavioral|stationary bike exercise|
16155008|NCT01741584|Behavioral|aerobic|
16155009|NCT01741571|Device|EBUS guided FNA with and without suction|"Device/procedure: lymph node tissue collection using needle with and without suction applied.
~Four fine needle aspirations will be taken from each lymph node. Two with suction and two without suction applied."
16155010|NCT01741558|Drug|Methotrexate|The treatment group will receive a bolus dose of 0.05 mg/kg of methotrexate before primary angioplasty followed by 0.05 mg/kg per hour for 6 hours
16155011|NCT01741558|Drug|Riboflavin|We use riboflavin in placebo group to remain the double-blind fashion: methotrexate has a yellow color and riboflavin in that concentration has the same color.
16155012|NCT01741545|Biological|Pegylated-Interferon-lambda|
16155013|NCT01741545|Drug|Ribavirin|
16155014|NCT01741545|Drug|Daclatasvir|
16155016|NCT01741532|Drug|Placebo|A deferiprone matching placebo oral solution will be given twice daily for 18 months.
16155017|NCT01741519|Drug|LDLL600|Comparison of 3 different doses LDLL600 in long-term infusion. 54 PK samples, BP and ECG measurement time points, several local tolerability measurement time points.
16155018|NCT01741519|Drug|Brevibloc|Comparison of 3 different doses Esmolol in long-term infusion. 54 PK samples, BP and ECG measurement time points, several local tolerability measurement time points.
16155019|NCT01741506|Drug|Dalteparin (Fragmin®)|
16155020|NCT01741493|Drug|ABT-494|Oral administration of ABT-494 capsules
16155021|NCT01741493|Drug|Placebo|Oral administration of placebo capsules
16155022|NCT01741493|Drug|Tofacitinib|Oral administration
16155023|NCT01741480|Other|Early warning system monitoring.|General hospital ward patients will be monitored 24/7 for clinical deterioration using the early warning system monitoring developed at Washington University.
16155024|NCT01741480|Other|routine care|
16155025|NCT01741467|Behavioral|RT-CGM|Dexcom Seven+
16155026|NCT01741454|Drug|Tamsulosin|0.4 mg by mouth once per day.
16155027|NCT01741454|Drug|Tolterodine ER|4 mg by mouth once a day.
16155028|NCT01741441|Procedure|laparoscopic total fundoplication|LTF was performed using a standard five-trocar technique in all cases and carried out by two expert surgeons who had previously performed more than 50 laparoscopic fundoplications. A floppy 360° total fundoplication of 2-2,5 cm was constructed after full esophageal mobilization and posterior crural repair with nonabsorbable sutures.
16155029|NCT01741428|Behavioral|Intervention (INT1)|"The course Program at the Feiring Heart Clinic will:
~Clinical examination and ergospirometric testing, optimizing both treatment and prophylactic medication. Promoting physical Activity, changes in lifestyle, dietary changes/weight reduction, smoking cessation. In the follow-up period the participants will be contacted and report regularly through a web-based secure program (MedAxess)(such as: Activity-, dietary- and smoking habits). Each participant will have their own Mentor, helping keeping up the motivation. They will also meet regularly at the local doctors Office which reports relevant parameters to the Project (such as weight, BP, Lipoproteins, blood glucose/HbA1C)"
16155030|NCT01741415|Behavioral|SIDI|
16155031|NCT01741415|Behavioral|SC|
16155032|NCT01741402|Device|Virtual Reality Training|The participants of the study trained 10 balance games during 14 sessions
16155033|NCT01741402|Other|Physical Therapy|Patients of the control group was trained with balance exercises.
16155034|NCT01741389|Drug|"Melatonin (Circadin)"|
16155035|NCT01741376|Drug|Progesterone|Progesterone 200 mg twice daily
16155036|NCT01741376|Drug|Placebo|
16155037|NCT01741363|Other|FIT(Eiken OC-Sensor) Two-day sampling|Collect two stool samples in two separate days
16155038|NCT01741363|Other|FIT(Eiken OC-Sensor) One-year interval|Screening with one-year interval
16155039|NCT01741363|Other|FIT(Eiken OC-Sensor) One-day sampling|One-day sampling
16155040|NCT01741363|Other|FIT(Eiken OC-Sensor) Two-year interval|Screening with two-year interval
16155041|NCT01741363|Other|HpSA (Firstep Helicobacter pylori Antigen Rapid Test)|HpSA for detection of upper gastrointestinal diseases; screen and treat for H. pylori infection. Upper endoscopy for H. pylori carriers. HPSA+FIT compared with FIT alone.
16155042|NCT01741350|Behavioral|Community-friendly Health Recovery Program|Four weekly HIV risk-reduction groups and routine clinical services (i.e., daily methadone and case management).
16155043|NCT01741350|Behavioral|Time-and-Attention-Matched Control Condition|Four weekly support groups and routine clinical services (i.e., daily methadone and case management).
16155044|NCT01741337|Procedure|Adaptive servo-ventilation post-operative treatment for 6 months|
16155045|NCT01741324|Dietary Supplement|Vitamin D 25 microg/d|The vitamin D supplement will be provided as a milk drink taken daily.
16155046|NCT01741324|Dietary Supplement|Vitamin D 10 microg/d|The vitamin D supplement will be provided as a milk drink taken daily.
16155047|NCT01741324|Dietary Supplement|No extra vitamin D|Milk drink with no extra vitamin D (placebo)
16155048|NCT01741311|Behavioral|3H+ (Holistic Health for HIV)|Four weekly HIV-risk reduction groups and an additional booster group held at week twelve summarizing the previous sessions' content, designed for opioid-dependent individuals living with HIV.
16155049|NCT01741311|Behavioral|HHRP+ (Holistic Health Recovery Program)|12 two-hour group sessions addressing HIV risk reduction behavior and recovery for opioid-dependent individuals living with HIV.
16155050|NCT01741298|Behavioral|CHARMS|Participants (Pts) randomized to the lifestyle intervention received a yr long, 17 session intervention. Pts were asked to wear a pedometer and record their food intake for at least the week prior to each session. The first 4 sessions were delivered weekly, followed by 4 sessions delivered biweekly and finally 9 sessions delivered monthly. Each session was approximately 1-2 hrs. At the beginning of each session anthropometric, physical activity and dietary data were collected. Participants were lead in a 5 min deep breathing exercise before the didactic portion of the session began. Sessions targeted a broad range of material related to diet, physical activity, and psychosocial well-being. Participants were given homework assignments to incorporate covered material into their daily lives. Participants randomized to the intervention arm received follow-up assessments at 6 and 12 months post randomization.
16155051|NCT01741285|Drug|Beclomethasone (QVAR)|Small particle treatment
16155052|NCT01741285|Drug|Beclomethasone (Clenil)|Course particle beclomethasone
16155053|NCT01741285|Drug|Fluticasone|Course particle treatment
16155056|NCT01741259|Drug|Meperidine|
16155057|NCT01741233|Genetic|VitDgen|
16155058|NCT01741207|Drug|N-acetylcystein|Active Comparator: N-acetylcystein receive N-acetylcystein in addition to standard treatment
16155059|NCT01741194|Drug|AC-1204|AC-1204 taken once daily, by mouth
16155060|NCT01741194|Drug|Placebo|Placebo taken once daily, by mouth
16155061|NCT01741181|Drug|Vitamin D supplementation|Vitamin D3 marketed by oneNine57
16155062|NCT01741181|Drug|Placebo Pill|Placebo pill supplied by oneNine 57 imported to Singapore with approval and import licence from HSA.
16155144|NCT01740557|Other|Laboratory Biomarker Analysis|Correlative studies
16155063|NCT01741168|Other|TLSO|Patients in the TLSO arm will remain on bed rest until fitted with a TLSO. They will wear the TLSO for 8-10 weeks and mobilized in the brace by a physiotherapist.
16155064|NCT01741168|Other|No Orthosis|Patients in the No Orthosis group will be mobilized immediately as tolerated by a physiotherapist with restrictions to limit bending or rotating through their trunk. They will be encouraged to return to normal activities after 8 weeks.
16155065|NCT01741155|Drug|SPI-1620|SPI-1620 11 μg/m2 administered intravenously over one minute.
16155066|NCT01741155|Drug|Docetaxel|Docetaxel: 75 mg/m2 administered as IV infusion.
16155067|NCT01741142|Drug|ABT-436|Subjects receiving ABT-436
16155068|NCT01741142|Drug|Escitalopram|Subjects receiving escitalopram
16155069|NCT01741142|Drug|Placebo|Subject receiving placebo
16155070|NCT01741129|Device|Nasal CPAP (SLE)|PEEP: 4-6 cmH2O, Flow: 8 to 10 L/minute
16155071|NCT01741129|Device|Nasal IMV (SLE)|PIP: 15-20 cmH2O, PEEP: 4-6 cmH2O, Inspiratory time: 0.4-0.5 second, Rate: 20-30 /minute
16155072|NCT01741116|Drug|TKI258|Investigational treatment refers to TKI258 in this study Until Progression, unacceptable toxicity, withdrawal
16155073|NCT01741103|Drug|sitagliptin|sitagliptin 100mg by mouth once a day for 12 weeks
16155074|NCT01741103|Drug|Placebo|Take one by mouth daily for 12 weeks
16155075|NCT01741090|Biological|mesenchymal stem cell injection|Hepatic artery catheterization and mesenchymal stem cell injection will be used in alcoholic liver cirrhosis. And before and 1 month after injection, change of liver cirrhosis and portal hypertension will be evaluated.
16155076|NCT01741077|Dietary Supplement|folic acid|subjects take multivitamin supplement containing folic acid. Women were enrolled based on whether or not they were taking supplements.
16155077|NCT01741051|Device|HEPA Filter|
16155078|NCT01741038|Biological|AlloStim®|AlloStim® is derived from the blood of normal blood donors and is intentionally mismatched to the recipient. CD4+ T-cells are separated from the blood and differentiated and expanded for 9-days in culture to make an intermediary called T-Stim. AlloStim is made by incubating T-Stim cells for 4h with antibody coated microbeads. The cells with the beads still attached are suspended in infusion media and loaded into syringes. The syringes are shipped refrigerated to the point-of-care.
16155079|NCT01741038|Procedure|cryoablation|percutaneous ablation of a single metastatic tumor lesion usually in liver. The procedure is conducted under CT or ultrasound image-guidance.
16155080|NCT01741038|Other|Physician's Choice (PC)|Physician's Choice therapy can consist of best supportive care (BSC) or any US-FDA approved cancer drug (e.g. Cetuximab) administrated as a monotherapy at the manufacturer's recommended dose. The treatment schedule shall be prospectively determined and administered as tolerated
16155081|NCT01741025|Device|iFuse Implant System|Placement of iFuse implant system via surgery
16155082|NCT01741025|Other|Conservative Management|Medications for pain, physical therapy, cognitive behavour therapy
16155083|NCT01741012|Drug|Gardasil|0.5 ml Gardasil vaccine in single dose prefilled syringes at Visit 2, Visit 4 and Visit 6
16155084|NCT01740999|Procedure|silicone arthroplasty|silicone arthroplasty
16155085|NCT01740999|Procedure|arthrodesis|arthrodesis
16155086|NCT01740986|Drug|SA09012 Low dose|Tablet, b.i.d
16155087|NCT01740986|Drug|SA09012 High dose|Tablet, b.i.d
16155088|NCT01740986|Drug|Placebo|Tablet, b.i.d
16155089|NCT01740960|Drug|delta-9-tetrahydrocannabinol|During the intervention phases, subjects will be randomly allocated to receive 1 of 3 doses Namisol®: 3 mg, 5 mg, 6,5 mg (or placebo) The washout period between the intervention periods will be at least 2 weeks.
16155090|NCT01740960|Drug|Placebo|On each intervention day the subjects will receive the same amount of drugs in order to insure the blinding of the study
16155091|NCT01740947|Drug|Selective decontamination of the digestive tract (SDD) (colistin sulfate, tobramycin, amphotericin B)|SDD suspension contains per dose of 10 ml 100 mg colistin sulfate, 80 mg tobramycin and 500 mg amphotericin B
16155092|NCT01740934|Other|Anatabloc Cream|subject will apply active cream topically, twice per day according to instructions
16155093|NCT01740934|Other|Placebo Cream|subject will apply placebo cream topically, twice per day according to instructions
16155094|NCT01740921|Drug|Liraglutide|Administered once daily
16155095|NCT01740921|Other|diet|reduction of caloric intake to promote weight loss
16155096|NCT01740921|Drug|Aspirin|300mg of Aspirin per day
16155097|NCT01740908|Other|Hyperbaric Oxygen Treatment|"Hyperabric oxygen will be delivered via a PerryPerry-Sigma Monoplace Hyperbaric Chambers. Oxygen is supplied by Air Gas, Seattle.
~All gases will meet Health Standards for oxygen and air. The hyperbaric chamber technicians employed by Restorix Health are trained health personnel who will be assisting our study participant and monitoring the HBO treatment. Oxygen will be delivered at a pressure of 2.0 ATA for 90 minutes, once a day for 5 consective days."
16155098|NCT01740869|Other|Stem cells|
16155099|NCT01740856|Other|Rest three hours|Intervention group (IG), will maintain bed rest supine for two hours after the digital compression. After this period prescribed, patients sit in bed with the head elevated at 45 degrees for 50 minutes and then walk within the unit hemodynamic for about 10 minutes. Afterwards patients remain sitting out of bed in hemodynamics unit, until they are five hours, then they will be discharge.
16155100|NCT01740856|Other|Rest five hours|Control group (CG) maintain bed rest supine for four hours after the digital compression. After this period, the patients sit in bed with the head elevated at 45 degrees for 50 minutes and then walk into the unit hemodynamic for 10 minutes. After that patients receive discharge.
16155101|NCT01740843|Device|transcranial direct current stimulation (tDCS) (NeuroConn DC-stimulator)|The anode is fixed on the primary cortex and the cathode will be fixed on the contralateral supraorbital region.
16155102|NCT01740830|Device|Transcranial Direct Current Stimulation (tDCS) (Neuroconn DC-stimulator)|The anode will be fixed over the primary motor cortex. The cathode will be fixed over the contralateral supraorbital region.
16155103|NCT01740817|Drug|Intralipid 20%|30 ml/h for 48 h
16155104|NCT01740817|Drug|Saline|30 ml/h for 48 h
16155105|NCT01740791|Drug|Velpatasvir|Tablets administered orally
16155106|NCT01740791|Drug|Placebo|Tablets administered orally
16155145|NCT01740557|Biological|NGFR-transduced Autologous T Lymphocytes|Given IV
16155146|NCT01740557|Other|Quality-of-Life Assessment|Ancillary studies
16155107|NCT01740765|Other|24-hour energy expenditure|To assess 24-hour energy expenditure and substrate utilization subjects will spend 23 hours and 15 minutes each day in the metabolic chamber at the UNC NRI. Subjects will be requested to arrive at the study center each morning following a 10hour overnight fast. During each study day, subjects remained sedentary. All meals were provided and were tailored to each subject's specific energy requirements and the study protocol (i.e. 50% or 150% of calorie requirements).
16155108|NCT01740752|Behavioral|UCAN+CBT|weekly manualized couple therapy plus weekly manualized individual CBT
16155109|NCT01740752|Behavioral|CBT|"weekly manualized higher dose of individual CBT"
16155110|NCT01740726|Behavioral|Behavioral Activation|18 weeks of 1-hour individual therapy focused on increasing rewarding behaviors. Therapy follows Behavioral Activation manual supported through previous research of this therapy for adolescents. BA intervention includes monthly booster sessions offered throughout 6-month follow up.
16155111|NCT01740726|Drug|Fluoxetine|Initial 10mg dose titrated as necessary to 40mg daily; weekly visits for 4 weeks, biweekly visits for next 6 weeks, monthly visits for remaining 8 weeks of active treatment and through 6-month follow up. Therapists will be available between sessions and throughout the follow-up interval to manage clinical concerns or emergencies.
16155112|NCT01740713|Drug|Deferiprone, dose level 1|a solution at 80 mg/mL will be administered orally
16155113|NCT01740713|Drug|Deferiprone, dose level 2|a solution at 80 mg/mL will be administered orally
16155114|NCT01740713|Drug|Deferiprone, dose level 3|a solution at 80 mg/mL will be administered orally
16155115|NCT01740700|Device|p-Branch®|Instead of making a large incision in the abdomen, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
16155116|NCT01740687|Device|ESS305 (Essure, BAY1454032)|Essure Permanent Birth Control
16155117|NCT01740687|Procedure|NovaSure|Nova Sure Endometrial Ablation
16155118|NCT01740674|Other|Electronic data collection|
16155119|NCT01740661|Other|Cryotherapy|The subjects will be exposed to a cold (~ 12° C) water immersion tub at the umbilical level for 20 minutes.
16155120|NCT01740661|Other|Control|The subjects will be exposed to a non-cold (~ 26° C) water immersion tub at the umbilical level for 20 minutes.
16155121|NCT01740648|Drug|trametinib|Trametinib will be given for 5-day lead-in period by mouth daily Monday-Friday starting at day -14 through -10 and concurrently for the duration of radiation therapy (approximately days 1-38).The dose of Trametinib will be escalated: 0.5 mg, 1.0 mg, 2mg. If the 2 mg dose level causes DLT (dose-limiting toxicity)in 2 out of 6 patients and the 1mg dose level was acceptable, then a 1.5 mg dose cohort will be used.
16155122|NCT01740648|Drug|fluorouracil|Will be administered as a continuous infusion over 120 hours at a dose of 225 mg/m2/day on Monday to Friday of every week starting day 1-38.
16155123|NCT01740648|Radiation|radiation therapy|Radiation therapy will be delivered to the pelvis during (approximately) days 1-33 (five days a week, Mondays through Fridays for 25 fractions) using a 3-field or 4-field 3-D conformal plan to the primary tumor, surrounding soft tissues, and at risk lymph node stations (peri-rectal, presacral, internal iliac, with or without external iliac) to a total dose of 45 Gy in 1.8 Gy daily fractions. A boost radiation field will be delivered during (approximately) days 36-38. The boost will encompass the primary rectal tumor and involved lymph nodes with a 2-2.5 cm margin, which should include the presacral space. The boost dose will be 5.4 Gy in 1.8 Gy fractions for a total dose of 50.4 Gy.
16155124|NCT01740635|Device|EPIC WheelS Training Program|Subjects will attend an initial assessment/training session and receive a customized home program from their Trainer, which is delivered by way of a portable, interactive computer tablet that can be used for practice in their home or other community venues. After 2 weeks of practice, subjects return for a second 1-hour training session. The Trainer updates their program and they continue practicing at home for another 2 weeks. Subjects will have a caregiver attend all training sessions and supervise their home training. Trainers monitor subject activity remotely and will contact subjects by telephone at the end of weeks 1 and 3 to promote program adherence. Participants in an extra wheeling sub-group will be instructed to perform additional, unstructured wheeling for 15 minutes, 5 days per week and document these on a simple calendar-style form provided.
16155125|NCT01740622|Other|Injury Prevention Measures|The hazards identified in the home will be reviewed with the parent and the proposed interventions will be presented. Intervention options are designed and prioritized so that the most passive and durable interventions are recommended first (e.g. self-closing, self-locking stair gate) and progressively less 'passive' and less durable options last (e.g. area gate, pressure mounted gate, or refusal of intervention).
16155126|NCT01740609|Drug|Placebo|Placebo
16155127|NCT01740609|Biological|PF-06342674 Dose A|Single SC Dose
16155128|NCT01740609|Biological|PF-06342674 Dose B|Single SC Dose
16155129|NCT01740609|Biological|PF-06342674 Dose C|Single SC Dose
16155130|NCT01740609|Biological|PF-06342674 Dose D|Single SC Dose
16155131|NCT01740609|Biological|PF-06342674 Dose E|Single SC Dose
16155132|NCT01740609|Biological|PF-06342674 Dose F|Single IV Dose
16155133|NCT01740609|Biological|PF-06342674 Dose G|Single SC Dose
16155134|NCT01740609|Biological|PF-06342674 Dose H|Single IV Dose
16155135|NCT01740609|Biological|PF-06342674 Dose I|Single SC Dose
16155136|NCT01740609|Biological|PF-06342674 Dose J|Single IV Dose
16155137|NCT01740596|Device|C-Pulse® System Counterpulsation|The Sunshine Heart C-Pulse System is an implantable, non-blood contacting, non-obligatory, heart assist device. The system provides cardiac assistance through an extra-aortic balloon Cuff and ECG sense lead connected by means of a Percutaneous Interface Lead (PIL) to an external pneumatic Driver. The PIL is held secure externally, at the exit site, with a simple adhesive clip (C-Patch or similar) for immobilization of the external part of the PIL. The Driver is adjusted using a dedicated notebook computer (Programmer) with specialized software.
16155138|NCT01740583|Device|percutaneous annuloplasty|plication of the mitral valve annulus
16155139|NCT01740570|Drug|Cabazitaxel|"Phase I Starting Dose: Cohort 1A) 25 mg/m2 by vein over 1 hour every 3 weeks. Cohort 1B) 20 mg/m2 by vein over 30 minutes every 3 weeks.
~Phase II: Maximum tolerated dose from Phase I."
16155140|NCT01740557|Biological|Aldesleukin|Given IV
16155141|NCT01740557|Biological|CXCR2-transduced Autologous Tumor Infiltrating Lymphocytes|Given IV
16155142|NCT01740557|Drug|Cyclophosphamide|Given IV
16155143|NCT01740557|Drug|Fludarabine Phosphate|Given IV
16155149|NCT01740531|Biological|S-303 Treated Red Blood Cells (RBCs)|
16155150|NCT01740531|Biological|Conventional, untreated Red Blood Cells|
16155151|NCT01740518|Drug|polyethylene glycol, ascorbic acid|comparison of different solutions for bowel preparation
16155152|NCT01740505|Behavioral|Timing and Coordination|This intervention is based on progressively difficult stepping and walking patterns that promote the timing and coordination of stepping within the gait cycle. Small-group 60-minute classes twice weekly for 12 weeks.
16155153|NCT01740505|Behavioral|Aerobic Walking|Outdoor walking with progressive increases in exercise intensity. Small-group 60-minute classes twice weekly for 12 weeks.
16155154|NCT01740505|Behavioral|Stretching and Relaxation|Full-body stretching, range-of-motion exercises, and relaxation techniques. No specific gait training. Small-group 60-minute classes twice weekly for 12 weeks.
16155155|NCT01740492|Drug|Ketamine 0.15mg/kg|0.15mg/kg ketamine delivered IV (in the vein) following clinician assessment in ER. Number of cycles: until discharge or 6 hours elapses.
16155156|NCT01740492|Drug|Ketamine 0.3mg/kg|0.3 mg/kg ketamine delivered IV (in the vein) following clinician assessment in ER. Number of cycles: until discharge or 6 hours elapses.
16155157|NCT01740492|Other|Placebo|Placebo injection of 0.9% normal saline of a similar volume (0.05ml/kg)
16155158|NCT01740479|Procedure|Complete Revascularization Strategy|Staged PCI using second generation drug eluting stents (Promus Element Plus drug-eluting stent or newer version in this series is strongly recommended) of all suitable non-culprit lesions plus optimal medical therapy.
16155159|NCT01740453|Drug|ropivacaine 2 mg/ml|single
16155160|NCT01740440|Device|BMR Face|BMR Face used in accordance with manufacturer IFU
16155161|NCT01740427|Drug|PD-0332991|PD-0332991, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
16155162|NCT01740427|Drug|Letrozole|Letrozole, 2.5mg, orally once daily (continuously)
16155163|NCT01740427|Drug|Placebo|Placebo, 125mg, orally once daily on Day 1 to Day 21 of every 28-day cycle followed by 7 days off treatment
16155164|NCT01740427|Drug|Letrozole|Letrozole, 2.5mg, orally once daily (continuously)
16155165|NCT01740414|Drug|MN-166 (50 mg) First|In this arm of the study participants were first maintained on 50 mg MN-166 BID for approximately 14 days, and were then switched onto placebo maintenance. The subjective and analgesic effects of Oxycodone (0 mg, 15 mg and 30 mg) were tested under each of the two maintenance conditions (Placebo & MN-166).
16155166|NCT01740414|Drug|Placebo First|This arm of the study participants were first maintained on placebo for approximately 14 days, and were then switched onto 50mg MN-166 BID maintenance. . The subjective and analgesic effects of Oxycodone (0 mg, 15 mg and 30 mg) were tested under each of the two maintenance conditions (Placebo & MN-166).
16155167|NCT01740401|Drug|Cyclophosphamide|This study consists of a Treatment Period, D1 Zofran 8mg pre-Cyclophosphamide 300mg/mg2 po and D3 Ipilimumab 10mg/kg iv wks 1,4,7 and 10; Tumor assessment at week 12; Follow-Up period weeks 13,16,and 20 with no treatment; Maintenance Period, D1 10mg/kg iv wks 24,36,48 and 60. Week 40=end of treatment; week 60=end of study
16155168|NCT01740388|Drug|Besifloxacin|one drop of besifloxacin ophthalmic suspension 0.6% administered to infected study eye(s) BID for 3 days.
16155169|NCT01740388|Drug|Vehicle|one drop of the vehicle of besifloxacin ophthalmic suspension administered to infected study eye(s) BID for 3 days.
16155170|NCT01740375|Procedure|esophagectomy|esophagectomy
16155171|NCT01740362|Drug|CP-690,550|10 mg (2 x 5 mg tablets), single dose
16155172|NCT01740362|Drug|CP-690,550|10 mg (2 x 5 mg tablets), single dose
16155173|NCT01740362|Drug|CP-690,550|10 mg (2 x 5 mg tablets), single dose
16155174|NCT01740362|Drug|CP-690,550|10 mg (2 x 5 mg tablets), single dose
16155175|NCT01740336|Drug|GDC-0941|GDC-0941 will be administered QD orally for 5 consecutive days each week.
16155176|NCT01740336|Drug|Placebo|Placebo matching to GDC-0941
16155177|NCT01740336|Drug|Paclitaxel|Paclitaxel will be administered IV weekly for 3 out of 4 weeks in every 28-day cycle.
16155178|NCT01740323|Drug|Placebo|daily placebo for 6 weeks
16155179|NCT01740323|Drug|Curcumin|500 mg BID
16155180|NCT01740310|Behavioral|Maternal Vaccine Education|It is assumed that the women will also receive vaccine education materials from the OB/GYN practices as part of routine care. The intervention for all three arms will be conducted during routine prenatal office visits. Participants will complete a baseline questionnaire to assess attitudes regarding vaccination and will then be randomized to one of three enrollment arms and will be exposed to an intervention designed to take no longer than 20 minutes, so that patients can complete it during the time they are waiting to be seen. While participants are completing the handheld/electronic tablet device-based intervention, the study recruiter will observe them and document dose exposure to the messages being presented. The enrolled women will be contacted a month after the expected date of delivery and a follow up interview will be conducted to ascertain their vaccination status for receipt of influenza vaccine in pregnancy and Tdap during pregnancy or immediately post-partum.
16155181|NCT01740297|Drug|Talimogene laherparepvec|Talimogene laherparepvec administered by intratumoral injection on Day 1 of Week 1, Day 1 of Week 4, then every two weeks thereafter.
16155182|NCT01740297|Drug|Ipilimumab|Ipilimumab administered intravenously every 3 weeks for a total of 4 infusions.
16155183|NCT01740284|Drug|Grazax + Aerius|
16155184|NCT01740284|Drug|Grazax + placebo|
16155185|NCT01740271|Drug|Epirubicin|
16155186|NCT01740258|Radiation|Radiation Therapy|
16155187|NCT01740258|Drug|Temozolomide|
16155188|NCT01740258|Drug|Bevacizumab|
16155189|NCT01740245|Device|Chlorhexidine vaginal suppositories|
16155190|NCT01740245|Device|Polyhexamethylene biguanide vaginal suppositories|
16155191|NCT01740232|Procedure|trephination|Artroscopic meniskal repair with trephination.
16155192|NCT01740232|Procedure|Normal meniscal repair|Artroscopic meniskal repair without trephination.
16155193|NCT01740219|Behavioral|Capacity Enhancement|Churches in the Capacity Enhancement intervention will be invited to work with CRUZA staff over the course of a three month intervention to implement health promotion activities in their church and participate in capacity-building educational workshops. Participants may also receive technical assistance from Health Educators in order to implement their cancer education activities.
16155352|NCT01738919|Procedure|Conservative treatment with splinting for 6 weeks.|Aluminum Karstam splints are used.
16155194|NCT01740219|Behavioral|Standard Dissemination|Churches in the Standard Dissemination arm will receive program materials with information about cancer prevention/early detection and health resources.
16155195|NCT01740206|Drug|Amphetamine and/or methylphenidate|Patients who took their stimulant medication the day of surgery.
16155196|NCT01740206|Other|Hold stimulant medication|Patients who held their stimulant medication the day of surgery.
16155197|NCT01740193|Procedure|TAP Block|While the terminal branches of T7 to L1 cannot be visualized under ultrasound as they pass between the internal oblique and the transverse abdominis muscles, they are expected to lie within this plane. The three muscular layers of the abdominal wall, however, can be easily identified under ultrasound guidance. A needle is advanced under ultrasound guidance towards the fascial plane that separates the internal oblique and the transversus abdominis muscles, at which point local anesthetic is deposited under direct visualization.
16155198|NCT01740193|Procedure|Ilioinguinal/iliohypogastric blockade|Ilioinguinal and iliohypogastric blockade is performed as an injection after palpation of the anterior superior iliac spine followed be a perceived loss of resistance with insertion of the needle, or may be infiltrated locally following herniorrhaphy exposure as anatomic landmarks can prove to be difficult to locate in the anesthetized pediatric patient.
16155199|NCT01740180|Other|Data entry|"This cohort describes the basic information about the patients (age, sex, weight, height, background) as well as acts required, treatment and results of imaging studies.
~These data are extracted from patient records by each participating center and collected in an e-CRF."
16155200|NCT01740167|Behavioral|health promotion lifestyle program|Individual counseling, once a month, total 3 times.
16155201|NCT01740154|Procedure|transcranial magnetic stimulation|Undergo TMS
16155202|NCT01740154|Procedure|electromyography|Undergo EMG
16155203|NCT01740154|Other|survey administration|Ancillary studies
16155204|NCT01740154|Drug|sunitinib malate|Given PO
16155205|NCT01740141|Procedure|Plexus brachialis block|
16155206|NCT01740128|Device|Robotic body weight supported treadmill training|30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.
16155207|NCT01740128|Other|Harness-supported multimodal balance training|30-minute sessions will be conducted 3-4 times per week for a total of 48 sessions over 12 to 16 weeks.
16155208|NCT01740102|Procedure|RIPC|The remote ischemic preconditioning will consist of three sequential sphygmomanometer cuff inflations. The cuff will be inflated up to 200 mmHg for 5 minutes and then deflated for 5 minutes. This cycle will be performed three times in total. The entire preconditioning will therefore last for 25 minutes.
16155209|NCT01740089|Drug|Algeron|1.5 μg/kg or 2.0 μg/kg of body weight weekly subcutaneously
16155210|NCT01740089|Drug|PegIntron|1.5 μg/kg/week subcutaneously in combination with ribavirin
16155211|NCT01740089|Drug|Ribavirin|800-1400 mg/day orally
16155212|NCT01740076|Other|soy nuts|
16155213|NCT01740063|Drug|DAS181-F02 formulation|
16155214|NCT01740063|Drug|DAS181-F04 formulation|
16155215|NCT01740063|Drug|Placebo|
16155216|NCT01740050|Dietary Supplement|Very Low Calorie Diet (VLCD)|One subject group will lose 10% of initial body weight using a VLCD. There are no risks for the subjects in consuming the VLCD (Modifast, together with the recommended fruit and vegetables) as the macronutrient composition and vitamins/minerals content meet the Dutch recommended daily allowance.
16155217|NCT01740050|Procedure|RYGB|
16155218|NCT01740050|Procedure|LAGB|
16155219|NCT01740037|Other|Specialized outpatient AF Clinic|
16155220|NCT01740037|Other|Usual Care|
16155221|NCT01740024|Biological|1 (Dose Response Skin Prick Tests)|3 different cat epithelium allergenic extracts at 3 different concentrations, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.
16155222|NCT01740011|Procedure|Laparoscopic surgery|
16155223|NCT01739998|Dietary Supplement|functional oil|
16155224|NCT01739998|Dietary Supplement|Placebo|
16155225|NCT01739985|Drug|Dexamethasone + ondansetron + Placebo|Administration of ondansetron and dexamethasone immediately after induction of anesthesia. Ondansetron is administered at a dose of 100 micrograms.kg-1, dexamethasone at a dose of 125 microg x kg-1.Administration of the saline 30 minutes before the end of surgery
16155226|NCT01739985|Drug|Dexamethasone + ondansetron + Droperidol|Administration of ondansetron and dexamethasone immediately after induction of anesthesia. Ondansetron is administered at a dose of 100 micrograms.kg-1, dexamethasone at a dose of 125 microg x kg-1Administration of droperidol 30 minutes before surgery at a dose of 50 micrograms.kg-1
16155227|NCT01739972|Drug|Levothyroxine|Levothyroxine in a capsule form, once daily, with appropriate dosage to keep TSH in the normal range.
16155228|NCT01739972|Drug|Desiccated thyroid extract|Armour thyroid in a capsule form, once daily, with appropriate dosage to keep TSH in normal range.
16155229|NCT01739933|Drug|Dexmedetomidine|For patients in the dexmedetomidine group, dose will range from 0.15-1.5 mcg/kg/hr. For example, a 70 kg patient would receive 10.5 mL of study drug per hour, which would provide 0.75 mcg/kg/hr of dexmedetomidine. This dose range have been selected after literature review and discussions with critical care practitioners, investigational pharmacists, and the MENDS2 study steering committee.
16155230|NCT01739933|Drug|Propofol|For patients in the propofol group, dose will range from 5-50 mcg/kg/min. For example, a 70 kg patient would receive 10.5 mL of study drug per hour, which would provide 25 mcg/kg/min of propofol. This dose range has been selected after literature review and discussions with critical care practitioners, investigational pharmacists, and the MENDS2 study steering committee.
16155231|NCT01739920|Other|Povidone-iodine|Povidone iodine 5% drop will be instilled into conjunctival sac.
16155232|NCT01739920|Other|Saline Solution|1 drop of saline solution 0.9% will be instilled into conjunctival sac.
16155233|NCT01739907|Other|Iron fortified flavoured skimmed milk with or without vitamin D in iron deficient women|
16155234|NCT01739894|Drug|IP Paclitaxel|Each treatment cycle will consist of 21 days, with 14 days on treatment and 7 days off-treatment. Oxaliplatin will be administered intravenously (on Day 1 of each cycle). Paclitaxel will be administered intra-abdominally on Day 1 and Day 8 of each cycle. In particular, a needle will be inserted into the intraperitoneal injection port for normal saline to be injected intra-abdominally over one hour, followed by paclitaxel chemotherapy over a further one hour. Capecitabine will be taken by mouth from Day 1 to 14 of each cycle.
16155235|NCT01739881|Device|Olympus Ultrathin Bronchofibervideoscope (XP260F)|The bronchovideoscope will be used together with an assisted image-guided bronchoscopic navigation software system called LungPoint®, to view lungs in a real time 3D manner.
16155236|NCT01739868|Other|Biopsies of muscular and fat tissue|"3 half days of metabolic exploration including blood sample, urinary taking, OGTT (oral glucose tolerance test), biopsies of muscular and fat tissue:
~1 visit the first year (inclusion visit)
~1 visit at the end of 5 years of follow-up or in the appearance of type 2 diabetes
~1 intermediary visit (in 3 years) or activated by the following conditions:
~Escalation of the glycemia (increase of 0.1g / l of the glycemia and/or 0.3 % of the HbA1c)
~Normalization of the glycemia (fasting blood glucose < 1 g/l)"
16155237|NCT01739855|Drug|Calciferol, calcium carbonate|
16155238|NCT01739842|Dietary Supplement|Kudzu extract|
16155239|NCT01739829|Device|DIABECELL (R)|10,000 IEQ per kg body weight (Total Dose) Administered in two doses: 5,000 IEQ/kg three months apart.
16155240|NCT01739829|Device|DIABECELL (R)|20,000 IEQ per kg body weight (Total Dose) Administered in two doses: 10,000 IEQ/kg three months apart
16155241|NCT01739816|Behavioral|Medication review|"Polymedication Check (PMC) is a pharmacist's led medication review focusing medicines management, adherence issues and other drug related problems.
~The PMC has been implemented in 2010 as a new cognitive service provided by any community pharmacist to patient with polypharmacy (n>3 drugs) on long term conditions (> months). This specialised medication review follows a structured predefined protocol and is reimbursed by swiss health insurances.
~As an outcome, pharmacist may install a compliance support e.g. weekly filled pill organizer."
16155242|NCT01739803|Behavioral|Behavioral Contract|Intervention activities were performed by a study clinical pharmacist. Behavioral contract goal was achieving and maintaining IST adherence. Other components of the contract addressed: (a) motivation(s) or positive reinforcement for achieving IST adherence; (b) problems or barriers that may interfere with achieving IST adherence and possible solutions to overcome problems/barriers; (c) social support available to the RTR such as a significant other who may assist the RTR in following the IST dosing schedule; (d) tools/strategies the RTR may use to remind himself/herself to follow the IST dosing schedule; and (e) possible consequences of IST nonadherence (e.g., graft loss).
16155243|NCT01739790|Drug|N-Acetylcysteine|1800 mg twice daily for 8 weeks
16155244|NCT01739790|Drug|Placebo|Identical placebo manufactured to mimic appearance of intervention drug with identical frequency and duration.
16155245|NCT01739777|Biological|ucMSC|1 million mesenchymal cells per Kg weight injected intravenously in allogenic AB plasma
16155246|NCT01739777|Other|Controls|Autologous Serum will administrated as placebo
16155247|NCT01739764|Drug|Vemurafenib|Vemurafenib was given based on the last dose of the antecedent study (minimum 480 mg orally BID).
16155248|NCT01739751|Device|pedometers|portable device that estimate the number of steps walked daily
16155249|NCT01739738|Device|Ureteral Stent|patients who need to receive stent as per standard of care
16155250|NCT01739725|Device|Stent insertion|The patient will receive the helical stent
16155251|NCT01739712|Behavioral|Sleep extension|There will be a consultation with families to help youth to be successful in extending their sleep.
16155252|NCT01739712|Behavioral|Fixed Sleep Duration|There will be a consultation with families to instruct youth to maintain the same average nightly sleep duration during the modification week. The purpose is to control for time and attention.
16155253|NCT01739699|Drug|Acetaminophen|
16155254|NCT01739699|Drug|Placebo|
16155255|NCT01739686|Other|CASA Intervention|"CASA Intervention
~The CASA (Collaborative Care to Alleviate Symptoms and Adjust to Illness) intervention includes 3 components:
~A nurse (RN) follows structured algorithms to help patients with symptoms, specifically breathlessness, fatigue, pain, and depression.
~A social worker provides structured counseling targeting adjustment to illness and depression if present.
~A collaborative care model of care delivery, in which the nurse and social worker meet weekly with a primary care provider, cardiologist and palliative care specialist. This team makes medical recommendations to the intervention subjects' providers and supervises the nurse and social worker.
~Most of the nurse and social worker visits are by phone."
16155256|NCT01739673|Other|Ultraviolet-A and riboflavin|
16155257|NCT01739660|Drug|Pegloticase|a single 8 mg iv (in the vein) dose before hemodialysis session
16155258|NCT01739647|Drug|AZD3293|Oral solution
16155259|NCT01739647|Drug|Placebo|Oral solution
16155260|NCT01739634|Drug|CASAD|CASAD is provided in 500mg capsules.
16155261|NCT01739621|Drug|Proellex 12 mg|
16155262|NCT01739621|Drug|Proellex 24 mg|
16155263|NCT01739608|Other|Invitation to screening|Invitation to screening
16155264|NCT01739595|Drug|enclomiphene citrate|oral, capsules, taken one time daily, for 3 months
16155265|NCT01739595|Drug|Placebo|Oral capsule taken one time daily for 3 months
16155266|NCT01739582|Drug|Androxal|
16155267|NCT01739569|Other|Dietary treatment|Dietary treatment with healthy lunch and snack meal during working hours
16155268|NCT01739556|Drug|Antiplatelet Regimen Modification (aspirin or ticagrelor)|
16155269|NCT01739543|Device|Hem-Avert|Application of Hem-Avert
16155270|NCT01739530|Biological|Repaircell|allogenic differentiated adipocyte
16155271|NCT01739517|Drug|Omegaven Therapy|After baseline labs, which have been collected no earlier than seven days prior to the initiation of therapy are obtained, therapy with Omegaven will be initiated at a starting dose of 0.5 g/kg/day infused over 12 hours. If tolerated, the dose will be increased to 1 g/kg/day, the goal dose. Omegaven will be infused intravenously through either a central or peripheral catheter in conjunction with parenteral nutrition.
16155272|NCT01739504|Procedure|Liposuction with Local Anesthesia|Liposuction under tumescent anesthesia for adipose tissue harvesting.
16155273|NCT01739504|Biological|Intra articular infusion of AD-SVF|"Adipose tissue is available in most patients for harvest through minimally invasive procedures such as liposuction. AD-SVF can be obtained in large quantities after processing of adipose tissue in the laboratory.
~AD-SVF to promote tissue regeneration and repair with their ability to secrete various growth factors that can modulate host tissue environment.
~Patient's AD-SVF combined with PRP are used for direct intra-articular injection after processing."
16155353|NCT01738919|Procedure|Operative treatment with extension block technique|Surgery with extension block technique. 6 weeks.
16155354|NCT01738906|Other|Orange juice|
16155274|NCT01739491|Drug|No intervention|This is an obeservational study. Bendamustine hydrochloride will be administered (as per product insert) through intravenous infusion over 30-60 minutes at 100 mg/meter square body surface area on days 1 and 2 of a 28-day cycle.
16155275|NCT01739478|Other|Packing of abscess cavity|
16155276|NCT01739478|Other|External dressing|Application of external dressing whilst abscess cavity heals
16155277|NCT01739465|Procedure|Self expanding metallic stent (SEMS)|Self expanding metallic stent
16155278|NCT01739465|Procedure|Endoscopic radiofrequency ablation (ERFA)|Endoscopic radiofrequency ablation
16155279|NCT01739465|Procedure|Photodynamic therapy (PDT)|Photodynamic therapy
16155280|NCT01739439|Drug|gemcitabine hydrochloride|Given IV
16155281|NCT01739439|Radiation|hyperfractionated radiation therapy|Undergo hyperfractionated IMRT
16155282|NCT01739439|Radiation|intensity-modulated radiation therapy|Undergo hyperfractionated IMRT
16155283|NCT01739439|Radiation|radiosurgery|Undergo radiosurgery boost
16155284|NCT01739439|Procedure|diffusion-weighted magnetic resonance imaging|Correlative studies
16155285|NCT01739426|Device|Repair w/LigaSure|Surgical repair is carried out as normal except that a novel device is used: LigaSure V (TM) laparoscopic instrument (reference LS1500)
16155286|NCT01739413|Procedure|Anesthesia|Patients will be randomized to receive either epidural or general anesthesia for pain management throughout their surgery.
16155287|NCT01739400|Drug|Macitentan 10 mg tablet, once daily.|Macitentan 10 mg tablet, once daily.
16155288|NCT01739387|Device|Flutiform® pMDI and Breath Actuated Inhaler (BAI)|Both devices contain placebo
16155289|NCT01739374|Other|reduced mesh implants|mesh for pelvic floor reinforcement
16155290|NCT01739361|Drug|Acetaminophen|
16155291|NCT01739361|Drug|placebo|
16155292|NCT01739348|Drug|Verubecestat (Part I and Part II)|Single 12 mg verubecestat tablet once daily, taken orally
16155293|NCT01739348|Drug|Verubecestat (Part I and Part II)|Single 40 mg verubecestat tablet once daily, taken orally
16155294|NCT01739348|Drug|Verubecestat (Part I and Part II)|Single 60 or 40 mg verubecestat tablet once daily, taken orally
16155295|NCT01739348|Drug|Placebo (Part I)|Single placebo tablet matching verubecestat treatment once daily, taken orally
16155296|NCT01739348|Drug|Verubecestat (Part II)|Single 40 mg verubecestat tablet once daily, taken orally
16155297|NCT01739335|Drug|Mifepristone Oral Tablet [Korlym]|2 Mifepristone 300 MG Oral Tablets once daily (600mg total) for 7 days
16155298|NCT01739335|Drug|Placebo Oral Tablet|2 Placebo Oral Tablets once daily for 7 days
16155299|NCT01739322|Biological|Prick test Platanus acerifolia allergen extract|"This is an open, unblinded and non randomized biological as proposed by the Nordic Guidelines.
~Four concentrations of Platanus acerifolia allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm. This test will be referred to as the Titrated Skin Prick test."
16155300|NCT01739309|Drug|Abemaciclib|Administered orally
16155301|NCT01739296|Other|Neutral insole with subtalar strapping (sham)|Neutral insole with subtalar strapping (sham)
16155302|NCT01739296|Other|Lateral wedge insole with subtalar strapping|Lateral wedge insole with subtalar strapping
16155303|NCT01739283|Other|GIP|
16155304|NCT01739283|Other|GLP-1|
16155305|NCT01739283|Other|Saline|
16155306|NCT01739270|Procedure|supraclavicular brachial plexus block|
16155307|NCT01739257|Behavioral|Medical Lecture|
16155308|NCT01739257|Behavioral|Dramatic Reading|
16155309|NCT01739244|Drug|SYL040012|Ocular topical administration of SYL040012 for 14 consecutive days
16155310|NCT01739244|Drug|Placebo|Ocular topical administration of placebo for 14 consecutive days
16155311|NCT01739231|Biological|ACE527|"3x10^9 cfu ACE527 vaccine strain. Comprised of three genetically attenuated and engineered strains of E. coli, with antigen profiles covering a wide range of ETEC surface colonization factor antigens (CFA/I, CFA/II [CS1, CS2, CS3] and CFA/IV [CS5, CS6]) and also expressing LTB, the inactive subunit of LT (ETEC heat labile toxin). The constituent strains of ACE527 were:
~ACAM2025: a live, attenuated, CFA/I, LTB positive strain
~ACAM2022: a live, attenuated, CS5, CS6, LTB positive strain, and
~ACAM2027: a live, attenuated, CS1, CS2, CS3, LTB positive strain."
16155312|NCT01739231|Biological|dmLT|A derivative of wild-type enterotoxigenic Escherichia coli heat-labile enterotoxin that has been genetically modified by replacing the arginine at amino acid position 192 with glycine and the leucine at amino acid position 211 with alanine (13). These two amino acid substitutions take place in proteolytic cleavage sites which are critical for activation of the secreted toxin molecules.
16155313|NCT01739231|Biological|CeraVacx placebo|CeraVacx® is used to neutralize gastric acidity upon ingestion of vaccine. It was also used as the placebo in this study. CeraVacx® was prepared from the commercial product (Cera Products, Inc.); 9.5 grams were added to sterile water for each dose and mixed. Each dose contained 7 grams of rice syrup, 2 grams of sodium bicarbonate, and 0.5 grams of trisodium citrate.
16155314|NCT01739231|Biological|H10407 challenge strain|Approximately 2 x 10^7 cfu of the fully virulent ETEC strain. Previously administered to 91 volunteers at this challenge dose by the CIR clinical team over the previous 4 years in conjunction with other Phase 1/2b trials.
16155315|NCT01739218|Drug|Carboplatin|Carboplatin will be administered at a dose calculated according to the Calvert formula ([participant's glomerular filtration rate + 25] multiplied by the target area under the concentration-time curve [AUC] of 5 milligrams per milliliter per minute [mg/mL/min]), as intravenous [IV] infusion over 30-60 minutes [min] every 3 weeks).
16155316|NCT01739218|Drug|Paclitaxel|Paclitaxel will be administered at a dose of 175 milligrams per meter-squared [mg/m^2] as IV infusion over 3 hours using a rate controlling device every 3 weeks, or at a dose of 80 mg/m^2 as IV infusion over 1 hour using a rate controlling device every week (only during Cycles 5 to 8).
16155317|NCT01739218|Drug|Bevacizumab|Bevacizumab will be administered at a dose of 15 milligrams per kilogram [mg/kg] as IV infusion over 30-90 min every 3 weeks.
16155355|NCT01738906|Other|maltodextrin|
16155356|NCT01738906|Other|Vodka|
16155357|NCT01738906|Other|butter cake MSF|chewing on 40 gram cake for 6 minutes and before swallowing expectorating the bolus in cup.
16155358|NCT01738906|Other|butter cake consumption|chewing for 6 min on 40 gram cake and then swallow it.
16155318|NCT01739205|Behavioral|CALM-D Intervention|Participants (Pts) randomized to the lifestyle intervention received a yr long, 17 session intervention. Pts were asked to wear a pedometer and record their food intake for at least the week prior to each session. The first 4 sessions were delivered weekly, followed by 4 sessions delivered biweekly and finally 9 sessions delivered monthly. Each session was approximately 1-2 hrs. At the beginning of each session anthropometric, physical activity and dietary data were collected. Participants were lead in a 5 min deep breathing exercise before the didactic portion of the session began. Sessions targeted a broad range of material related to diet, physical activity, and psychosocial well-being. Participants were given homework assignments to incorporate covered material into their daily lives. Participants randomized to the intervention arm received follow-up assessments at 6 and 12 months post randomization.
16155319|NCT01739192|Drug|Bupropion|Subjects will be maintained on oral bupropion or placebo during the study.
16155320|NCT01739179|Procedure|VP Shunt Surgery for laparoscopic insertion of the peritoneal catheter|Patients in this Study Arm will receive a VP Shunt inserted laparoscopically
16155321|NCT01739179|Procedure|VP Shunt Surgery for open insertion of the peritoneal catheter|Patients in this Study Arm will receive a VP Shunt inserted openly
16155322|NCT01739166|Other|Practice-tailored intervention to increase rates of targeted services|"Over a 6 month period, the Practice Facilitator (PF), offers individualized suggestions, strategies and tools for streamlining processes and incorporating new ideas into the flow of a practice's work day to increase their rates of delivery of the 3 targeted services of lead screening, obesity detection and dental decay prevention.
~During the intervention visits the PF reviews a small number of recent well-visit charts. This allows for rapid feedback to a practice on their progress as they work toward reaching outcome measures. It also provides 'real time' feedback regarding the degree to which suggested interventions are working, allowing the PF to change the approach as needed."
16155323|NCT01739153|Other|Dietary intervention: CHEESE (High cheese intake)|
16155324|NCT01739153|Other|Dietary intervention: MEAT (High Meat intake)|
16155325|NCT01739153|Other|Dietary intervention: CARB (High Carbohydrate intake)|
16155326|NCT01739140|Behavioral|Yoga|
16155327|NCT01739127|Drug|Aripiprazole|To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study).
16155328|NCT01739127|Drug|Risperidone/Quetiapine|To be prescribed and monitored by participant's attending physician (not given to participants as a part of the study).
16155329|NCT01739114|Procedure|"IPPV group"|"Infants randomized into the IPPV group will receive mask IPPV with an initial PIP of 20 cmH2O and PEEP of 5 cm H2O, and a ventilation rate of 40-60 inflations/min until spontaneously breathing, at which time CPAP will be provided."
16155330|NCT01739114|Procedure|SI group|"Infants randomized into the SI group will receive two initial sustained inflations with a PIP of 20 cmH2O. After the two initial SIs infants will receive PEEP of 5 cm H2O and then CPAP if breathing spontaneously or, if found to have apnea or laboured breathing, mask IPPV with a PIP of 20 cmH2O and PEEP of 5 cmH2O at a rate of 40 to 60 bpm until spontaneously breathing, at which time CPAP will be provided"
16155331|NCT01739101|Behavioral|Reproductive Life Plan|A structured discussion based on the Reproductive Life plan, including information about reproduction and a brochure with the same information.
16155332|NCT01739088|Other|Remote ischemic pre-conditioning stimulus.|Forty eight to 24 hours prior to the surgery, patient assigned to remote ischemic pre-conditioning stimulus (RIPC) will have blood pressure cuffs placed on both lower limbs around the upper thigh, and will then have the cuff inflated around the lower limb to a pressure 10 mmHg above systolic blood pressure for 5 minutes, followed by 5 minutes of cuff deflation. This will be done sequentially on each lower limb for two cycles on each limb. In the operating room, after induction of anesthesia, the exact same procedure will be performed in the RIPC group. For each intervention, the legs will be covered by a drape, so that whether the cuff is being inflated around the leg or underneath the leg is not seen by any member of the health care team.
16155333|NCT01739088|Other|Sham Ischemic Pre-conditioning|In the control (sham Ischemic Pre-conditioning) group 48 to 24 hours prior to the surgery a cuff will be placed just underneath the upper thigh and the cuff will be inflated for 5 minutes, followed by 5 minutes of cuff deflation, done sequentially for two cycles on each side.In the operating room, after induction of anesthesia, the exact same procedure will be performed in the RIPC group.
16155334|NCT01739062|Genetic|Genetic risk assessment|
16155335|NCT01739049|Drug|Liraglutide|liraglutide
16155336|NCT01739049|Behavioral|Diet and Exercise|diet and exercise
16155337|NCT01739036|Biological|ChAd63 CS/ME-TRAP|Mixture of ChAd63 CS 5 x 1010 vp and ChAd63 ME-TRAP 5 x 1010 vp. Intramuscular needle injection.
16155338|NCT01739036|Biological|MVA CS/ME-TRAP|Mixture of MVA CS 2 x 108 pfu and MVA ME-TRAP 2 x 108 pfu. Intramuscular needle injection.
16155339|NCT01739036|Biological|ChAd63 CS/ME-TRAP/AMA1|Mixture of ChAd63 CS 5 x 1010 vp, ChAd63 ME-TRAP 5 x 1010 vp, and ChAd63 AMA1 5 x 1010 vp. Intramuscular needle injection.
16155340|NCT01739036|Biological|MVA CS/ME-TRAP/AMA1|Mixture of MVA CS 1.33 x 108 pfu, MVA ME-TRAP 1.33 x 108 pfu, and MVA AMA1 1.33 x 108 pfu. Intramuscular needle injection.
16155341|NCT01739036|Other|Controlled Human Malaria Infection Administered by Mosquito Bite|Approximately three weeks post MVA dosing.
16155342|NCT01739023|Biological|Autologous Human Schwann Cells|Schwann cells harvested from the sural nerve of the participant will be autologously transplanted into the epicenter of the participant's spinal cord injury.
16155343|NCT01738997|Device|Dilation 10 sec|
16155344|NCT01738997|Device|Dilation 2 min|
16155345|NCT01738984|Behavioral|MomZing Web Program|Online web platform that is accessed via a television connected to internet
16155346|NCT01738984|Behavioral|Standard Exercise DVD|Standard exercise DVD that demonstrates exercises a women does with an infant.
16155347|NCT01738971|Other|rapid access|Provision of box which the participant can take to local family planning clinic (contraceptive service) allowing rapid access (i.e. will be seen by a health professional for a consultation regarding contraception there and then).
16155348|NCT01738971|Other|one month progestogen only pill|Provision of 1 month supply of a progestogen only pill (levonorgestrel 35mcg - Norgeston, Bayer, UK)
16155349|NCT01738958|Biological|L. retueri|two tablets a day for 6 weeks
16155350|NCT01738958|Biological|Placebo|
16155351|NCT01738945|Drug|Amlodipine|10 mg/day for 12 weeks
16155359|NCT01738893|Drug|Gabapentin 300 mg|Test product
16155360|NCT01738893|Drug|Gabapentin 300 mg|Reference product
16155361|NCT01738880|Drug|SVV|During the surgery, patients in group S receive additional fluids (400 ml of normal saline or 200 ml of colloid) when SVV is less than 13.
16155362|NCT01738880|Drug|CVP|Patients in group C receive additional fluids (400 ml of normal saline or 200 ml of colloid) when CVP is less 8 during the surgery.
16155363|NCT01738867|Drug|GSK1521498|White HPMC capsule containing 10 mg of GSK1521498
16155364|NCT01738867|Drug|Naltrexone (NTX)|Swedish orange gelatin capsule containing 25mg of NTX or 50mg of NTX
16155365|NCT01738867|Drug|Placebo|Matching placebo capsules to GSK1521498 or NTX
16155366|NCT01738854|Procedure|intracuff pressure by cuff pressure manometer|36 patients are randomly allocated according to random sequence of the intracuff pressure 40, 60 and 80 cmH2O. After insertion of LMA supreme, we confirm adequate ventilation. And then we measure OLP and leakage volume at intra-cuff pressure 40, 60 and 80 cmH2O adjusted by cuff pressure manometer according to random sequence of the intracuff pressure.
16155367|NCT01738841|Biological|Priorix-Tetra™|Single dose, subcutaneous injection
16155368|NCT01738841|Other|Safety data collection|Recording of adverse events, using diary cards
16155370|NCT01738802|Dietary Supplement|Anti-oxidant and micronutrient|This group will be randomized to take the anti-oxidant and micronutrient supplement.
16155371|NCT01738802|Drug|Placebo|This group will take a placebo.
16155372|NCT01738763|Dietary Supplement|Pinitol|Three doses of Fruit Up® (diluted with mineral water to a final volume of 330 ml) were evaluated, and were equivalent to an intake of 2.5, 4.0 and 6.0 g of pinitol. The placebo beverage contained equal amounts of non-polyol carbohydrates with similar macronutrient composition and energy intake as that those obtained through the pinitol beverage, but excluding pinitol.
16155373|NCT01738750|Other|Cost Information Included|
16155374|NCT01738737|Device|Active Laser|18 points of application of active laser in the knee (frontal faces, lateral and medial)
16155375|NCT01738737|Other|Stretching exercises|7 stretching exercises for lower limbs lasting 30 seconds with 4 repetitions
16155376|NCT01738737|Device|placebo laser therapy|18 points of application of placebo laser in the knee (frontal faces, lateral and medial)
16155377|NCT01738724|Drug|Dienogest|Dienogest 2mg pills daily during 6 months
16155378|NCT01738724|Drug|Goserelin|Goserelin 10.8mg preloaded syringe subcutaneously at the start of the study and after 3 months
16155379|NCT01738724|Drug|Desogestrel|Desogestrel 75mcg pills daily during six months
16155380|NCT01738711|Behavioral|Cognitive behavioural therapy|Patient receive 2-6 sessions depending on individual need. first session is 1 hour duration with additional sessions approximately 30 minutes.
16155381|NCT01738698|Drug|SPD489 40mg|Oral administration of 40 mg once-daily for up to 12 weeks
16155382|NCT01738698|Drug|SPD489 100mg|Oral administration of 100 mg once-daily for up to 12 weeks
16155383|NCT01738698|Drug|SPD489 160mg|Oral administration of 160 mg once-daily for up to 12 weeks
16155384|NCT01738698|Drug|Placebo|Oral administration once-daily for 12 weeks
16155385|NCT01738685|Behavioral|Behavioral Intervention.|
16155386|NCT01738685|Other|Nutritional Education.|
16155387|NCT01738672|Drug|Inhaled nitrous oxide|Administration of nitrous oxide for labor analgesia
16155388|NCT01738659|Dietary Supplement|normal sodium diet|normal sodium diet (120 mmol/daily) for 1 year
16155389|NCT01738646|Drug|Vorinostat|
16155390|NCT01738646|Drug|Bevacizumab|
16155391|NCT01738633|Behavioral|nutritional counseling|
16155392|NCT01738633|Behavioral|respirology counseling|
16155393|NCT01738620|Behavioral|psychological counseling|
16155394|NCT01738620|Behavioral|prevention of sleep disorders in ICU|
16155395|NCT01738607|Dietary Supplement|Psyllium|
16155396|NCT01738607|Dietary Supplement|Gum Arabic|Gum acacia dietary fiber
16155397|NCT01738607|Dietary Supplement|carboxymethylcellulose|dietary fiber
16155398|NCT01738607|Dietary Supplement|Placebo|
16155399|NCT01738594|Drug|carfilzomib|Given IV
16155400|NCT01738594|Drug|romidepsin|Given IV
16155401|NCT01738594|Other|laboratory biomarker analysis|Correlative studies
16155402|NCT01738581|Device|Repetitive Transcranial Magnetic Stimulation|Applied to the premotor cortex at 1 Hz at 90% resting motor threshold for 1200 pulses.
16155403|NCT01738581|Behavioral|Sensorimotor Retraining|For sensorimotor retraining, a subset of the Learning-based Sensorimotor Training program was followed
16155404|NCT01738581|Behavioral|Non-specific Therapy|A non-specific massage and stretching program directed to the hand, wrist and forearm
16155405|NCT01738568|Behavioral|High intensity aerobic training|High intensity aerobic interval training will be performed 12-weeks. Exercise training will last 1 hour per day, 5 days per week and include high intensity interval cycling at ~70-95% maximum workload for 4 minutes followed by 3 minutes of rest.
16155406|NCT01738568|Behavioral|Sedentary Control|Sedentary control participants will not perform any regular exercise for 12-weeks.
16155407|NCT01738555|Drug|amdoxovir 300 mg bid|2 x 150 mg capsules bid
16155408|NCT01738555|Drug|amdoxovir 500 mg bid|2 x 250 mg capsules bid
16155409|NCT01738542|Drug|Bosentan|Bosentan 62.5 mg/12 hours (first four weeks) and 125 mg/12 hours (eight weeks)
16155410|NCT01738542|Drug|Antiaggregant therapy|AAS 100mg/d or Clopidogrel 75mg/d
16155411|NCT01738542|Drug|Statins|
16155412|NCT01738542|Drug|Antihypertensive therapy|
16155413|NCT01738529|Device|CLE ileocolonoscopy|The patients enrolled including the control group, will be investigated respectively, by conventional colonoscopy and CLE in both the terminal ileum as colon. The degree and extent of Crohn's disease are assessed by conventional ileocolonoscopy (SI), CLE (selected parameters) and histology biopsies. Then, the correlation between histology (gold standard), SI and CLE is calculated. An intra-and inter-observer study follows on CLE parameters, where 3 observers are blinded with respect to each other. The pathologist is blinded to conventional and CLE parameters. CLE results are stratified in order to identify which of the recorded CLE parameters that correlate best with the two other methods.
16155521|NCT01737619|Procedure|Lymphadenectomy|Undergo full lymphadenectomy
16155522|NCT01737619|Procedure|Positron Emission Tomography|Undergo PET/CT
16155414|NCT01738516|Procedure|Electroencephalography|Epileptic patients, as in healthy volunteers will be offered a review of EEG recording equipment resting on EEG-HR 256-channel EGI © in operation since January 2012 in the Van Gogh Service Unit of Neurology Rennes University Hospital (hospital Pontchaillou). The EEG is a routine now included in the Phase I report some epileptic patients during presurgical investigation. Patients to be included in this research protocol pass all review on the new device EEG-HR 256 channels. In addition to the rest condition, shared by both groups of participants, the healthy control subjects participate in two additional experimental tasks to be performed during recording. A picture naming task and a task of spelling words represented by these images.
16155415|NCT01738516|Procedure|Electroencephalography and additional experimental tasks|Epileptic patients, as in healthy volunteers will be offered a review of EEG recording equipment resting on EEG-HR 256-channel EGI © in operation since January 2012 in the Van Gogh Service Unit of Neurology Rennes University Hospital (hospital Pontchaillou). The EEG is a routine now included in the Phase I report some epileptic patients during presurgical investigation. Patients to be included in this research protocol pass all review on the new device EEG-HR 256 channels. In addition to the rest condition, shared by both groups of participants, the healthy control subjects participate in two additional experimental tasks to be performed during recording. A picture naming task and a task of spelling words represented by these images.
16155416|NCT01738503|Drug|RBP-6000|18% Buprenorphine Sterile Solution for subcutaneous (SC) injection using the ATRIGEL® Delivery System. Each injection of RBP-6000 is separated by a minimum of 28 days and given on alternate sides of the participant's abdomen.
16155417|NCT01738503|Drug|Subutex|Participants were inducted and stabilized over a 14-day period (study days -14 to -1) on SUBUTEX sublingual tablets. Tablets are placed under the tongue until dissolved.
16155418|NCT01738490|Device|Bone anchored hearing implant|
16155419|NCT01738477|Biological|Boostrix|Single dose intramuscular administration.
16155420|NCT01738451|Drug|GSK2118436 75 mg|Each capsule contains 75 mg of GSK2118436A as the mesylate salt, micronized particles as active equivalents.
16155421|NCT01738451|Drug|Placebo|Matching placebo capsules will be administered in Part 2 of the study.
16155422|NCT01738438|Drug|Cabozantinib|
16155423|NCT01738425|Drug|GIC-1001; 125 mg oral tablets|"Single ascending doses (SAD) from 125 mg to 1000 mg;
~Multiple ascending doses from 125 mg to 500 mg, TID over 7 successive days"
16155424|NCT01738425|Drug|GIC-1001 matching placebo|"Single ascending doses (SAD) [equivalent to active arm, 125 mg to 1000 mg]
~Multiple ascending doses, TID over 7 successive days [equivalent to the active arm, 125 mg to 500 mg]"
16155425|NCT01738412|Device|Neurokeeper stroke detector|Monitoring stroke patients
16155426|NCT01738399|Dietary Supplement|Coffee|
16155427|NCT01738399|Dietary Supplement|Placebo|
16155428|NCT01738373|Drug|Plerixafor|Plerixafor will be prescribed independently by the physician, according to usual practice.
16155429|NCT01738360|Drug|Arsenic trioxide|"The study duration was 30 months (24 months recruitment + 6 months follow-up).Thirteen patients will be successively included in this study at 6 different dose levels of arsenic trioxide (0.075, 0.10, 015, 0.20, 0.25 and 0.30 mg / kg / day). The treatment should be administered by IV infusion over 2 hours of D1 to D4 (conventional hospitalization) and at D8, D11, D15, D18, D22 and D25. The protocol starts at the dose of 0.10 mg / kg / day. The stage at the dose of 0.075mg/kg/day is planned in case of toxicity with the first stage at the dose of 0.10mg/kg/day.
~The course of study is as follows :
~Pre-inclusion between D-35 and D-15
~Ten injections during the first month distributed as follows : conventional hospitalization from D1 to D4 (one injection per day) and daily hospitalization day for injections at D8, D11, D15, D18, D22 and D25.
~A telephone contact between D32 and D34
~A consultation at D40 then monthly consultation at D60, D90, D120, D150 and D180"
16155430|NCT01738347|Drug|Arm 1 - GEH120714 (18F) Injection|Intervention is to administer GEH120714 (18F) Injection (100-270 Megabecquerel (MBq), single intravenous administration).
16155431|NCT01738334|Behavioral|Active comparator (meditation) with healthy subjects|"The control group with healthy subjects that was participate in meditation (active control group)"
16155432|NCT01738334|Behavioral|Meditation|"In the eight weeks following the first session of cognitive tests, the participants made a practice of weekly meditation group lasting 2 hours. Practices with each group (patients and active controls) occurred on different days. With regard to meditation practices were performed in a sitting posture with emphasis on daily life. Each weekly session involved meditation practices with trained professional, practical proposals for home exercise and a discussion group. Meditation compact discs (CDs)were given to participants for practices at home, which proposed activities for 5 minutes to 1 week and 2 weeks for 10 minutes 3-5, and finally 15 minutes for 6-8 weeks. After 8 weeks of treatment the second session of tests was held that involved the same tasks in session 1."
16155433|NCT01738321|Other|Cuff pressure|Measuring endotracheal tube (ETT) cuff pressure
16155434|NCT01738308|Procedure|Healing Touch|"When enter PACU + usual standard of care.
~The Healing Touch practitioner will be at the bedside when the patient is first brought to the PACU. The HT practitioner will center and then attune with the child, connecting their energy with the child and setting the intention for healing for the child's highest good. The practitioner will then place one hand on the center of the patient's chest in the high heart area. The practitioner will hold this position until they feel a deep connection and quieting within the patient's energy. When the patient is awake and parents have been called to the bedside the HT practitioner will energetically ground and release the patient,"
16155435|NCT01738308|Procedure|Healing Touch Sham Treatment|"The untrained in energy work study staff will be at the bedside when the patient is first brought to the PACU. The practitioner will then place one hand on the center of the patient's chest in the high heart area. This will continue until parents are called to the bedside"
16155436|NCT01738295|Drug|Donepezil administration|
16155437|NCT01738295|Drug|Placebo administration|
16155438|NCT01738282|Drug|Baclofen|
16155439|NCT01738282|Drug|Placebo (for baclofen)|
16155440|NCT01738256|Behavioral|Wellbeing intervention (ACT)|The intervention is based on principles of acceptance-commitment therapy (ACT). It aims to increase psychological flexibility through different exercises that are developed for improving skills of being present, dealing with thoughts and feelings, as well as support clarifying individual values and value-based actions. In addition exercises for relaxation, physical activity, and mindful eating are provided. The content of intervention for face-to-face and mobile groups is similar but delivery method is different.
16155441|NCT01738256|Behavioral|Wellbeing intervention (Internet)|The intervention is Duodecim Virtual Health Check and Coaching where the subject gets feedback based on his/her health information and is provided with different weekly tasks regarding lifestyle changes. The tasks are developed based on principles of cognitive behaviour therapy (CBT).
16155442|NCT01738256|Behavioral|No intervention|No intervention
16155443|NCT01738243|Drug|Hyaluronic Acid Gel injection|The conjunctiva is anesthetized with Proparacaine Hydrochloride Ophthalmic Solution, 0.5%. The upper eyelid is everted and the conjunctiva just superior to the upper tarsal edge is exposed. Using a 30-gauge needle, a single bolus of Hyaluronic Acid Gel is placed centrally in the subconjunctival levator-Muller plane. Small volumes (0.1 to 0.2 ml) of Hyaluronic Acid Gel are injected with the end point being adequate lowering with improved symmetry.
16155444|NCT01738243|Drug|Saline injection|The conjunctiva is anesthetized with Proparacaine Hydrochloride Ophthalmic Solution, 0.5%. The upper eyelid is everted and the conjunctiva just superior to the upper tarsal edge is exposed. Using a 30-gauge needle, a single bolus of saline is placed centrally in the subconjunctival levator-Muller plane. Small volumes (0.1 to 0.2 ml) of saline are injected with the end point being adequate lowering with improved symmetry.
16155445|NCT01738217|Procedure|Fluobeam|
16155446|NCT01738191|Drug|Atomoxetine|The study drug target dose is ATM 80mg per day; given as a once daily dose of an 80mg capsule. Patients will titrate up to target dose by starting on ATM 40mg capsules: 1 capsule daily for 14 days. Following study visit 3 (after 2 weeks on the titration dose), patients will increase the dose of ATM to 80mg daily.
16155447|NCT01738191|Drug|Placebo|
16155448|NCT01738178|Drug|Caffeine|
16155449|NCT01738178|Drug|Placebo|
16155450|NCT01738152|Other|HLA vaginal gel (HyaloGYN®),|Each participant will receive a HLA vaginal gel (HyaloGYN®), which is an over-the-counter, colorless gel to be administered for hydration and lubrication of the vaginal epithelium for women suffering dryness,as well as to the vulva for women suffering from vulvar symptoms. All participants will be instructed to insert the HLA gel into the vagina (with applicator) daily for the first 2 weeks, and then 3 times per week for 10 weeks. The women with vulvar symptoms at the baseline assessment will additionally be instructed to apply the HLA gel onto the vulva (manually) daily for the first 2 weeks, and then 3 times per week for 10 weeks. The participants will be assessed at 12 weeks. Participants receiving benefit from HyaloGYN®, as operationalized by improvement in both vaginal pH and VAS score will continue using the product 3 times per week for another 12 weeks and will receive a final vulvovaginal assessment at 24 weeks post-HLA treatment initiation.
16155451|NCT01738152|Behavioral|questionnaires|Assessment Form as part of routine clinical care. Participants will be asked to complete questionnaires at the baseline initial evaluation, 4-6 weeks, 12-14 weeks, and 22-24 weeks. The study information collected will be found in the standardized Clinical Assessment Form that patients complete as part of routine clinical care, along with an additional survey pertinent to the aims of the study. At 24 weeks, participants will complete an additional questionnaire that will ask questions regarding their experience with HyaloGYN® and their acceptability of and satisfaction with the product. Study participants must see the FSM NP or GYN clinician for the targeted exams at the study follow-up time points (4-6 weeks, 12-14 weeks, 22-24 weeks). PhD follow-up visits can be based upon the treatment plan of the patient. The study questionnaires and moisturizer diaries will be completed and collected during follow-up appointments with the GYN clinician or FSM NP.
16155452|NCT01738139|Drug|Imatinib Mesylate|Given PO
16155453|NCT01738139|Biological|Ipilimumab|Given IV
16155454|NCT01738113|Other|Open Kinetic Chain exercise|"Hamstrings strengthening exercise
~Quadriceps strengthening exercise
~Hamstrings stretch
~Hip extensors and abductors strengthening
~Calf-muscles stretching
~Strength exercise of ankle dorsiflexors & plantar flexors"
16155455|NCT01738113|Other|Closed kinetic chain exercise|"Foot sliding from sitting
~Seated Toe Raises
~Hamstrings and quadriceps co-contraction from sitting
~Bridging exercise
~Sitting-to-standing
~Side-to side, forward and backwards weight shifting
~Lunge exercise
~Squatting exercise
~Standing Toe Raises
~Standing Hamstrings Stretch"
16155456|NCT01738100|Drug|Ticagrelor|
16155457|NCT01738100|Drug|Clopidogrel|
16155458|NCT01738100|Drug|Morphine Sulfate|
16155459|NCT01738100|Drug|Saline|
16155464|NCT01738074|Biological|trivalent rotavirus genetic reassortment vaccine|
16155465|NCT01738074|Biological|Placebo|
16155466|NCT01738061|Behavioral|Multidimensional lifestyle intervention|Lecture series to increase awareness of the relationship of lifestyle to chronic diseases Individualized review and discussion to understand own health problems Biweekly group meetings to stimulate motivation and exchange ideas
16155467|NCT01738048|Procedure|Reconstruction|Reconstructive surgery after mastectomy, either by expander or autologous tissue. Includes both primary and secondary reconstruction
16155468|NCT01738035|Drug|NEFECON|All patients will receive a maximum recommended daily dose of an ACEI and/or ARB (or maximum tolerated dose not exceeding the maximum recommended daily dose) for the duration of the treatment and follow-up phases.
16155469|NCT01738035|Other|Placebo|All patients will receive a maximum recommended daily dose of an ACEI and/or ARB (or maximum tolerated dose not exceeding the maximum recommended daily dose) for the duration of the treatment and follow-up phases.
16155470|NCT01738022|Other|Administration of gas mixtures|
16155471|NCT01738009|Other|Induction of flow limitation|
16155472|NCT01737996|Drug|BI 207127 + faldaprevir|fixed dose combination
16155473|NCT01737983|Dietary Supplement|Lactobacillus reuteri|Lactobacillus reuteri was administered in 5 drops per day (10^10 colony-forming units) for 6 months.
16155474|NCT01737983|Dietary Supplement|placebo|The placebo was packed in identical bottles, had the same color, weight, smell, and taste of the probiotic formulation, was administered in 5 drops per day
16155475|NCT01737957|Device|Low-fluence PRP with 532nm green LASER|To administer low-fluence PRP in a single session for PDR
16155476|NCT01737957|Device|Full-Fluence PRP with 532nm LASER|To administer full-fluence PRP in two sessions for PDR
16155477|NCT01737944|Drug|Methotrexate (MTX)|Vibex MTX Device
16155616|NCT01736891|Drug|Rasagiline|Tablets, qd
16155478|NCT01737931|Drug|Topical steroid (Dexamethasone)|for SPM 962: 1 mg/24h patch for 48 hours as Acceleration period, then 2 mg/24h patch to the other site for 24 hours as Dose-escalation period, for steroid: twice daily administration of Dexamethasone (1 mg/g cream) to the application sites after the patch removal
16155479|NCT01737931|Drug|Topical antihistamine (Diphenhydramine)|for SPM 962: 1 mg/24h patch for 48 hours as Acceleration period, then 2 mg/24h patch to the other site for 24 hours as Dose-escalation period, for antihistamine: twice daily administration of Diphenhydramine (10 mg/g cream) to the application sites after the patch removal
16155480|NCT01737918|Procedure|TOT|
16155481|NCT01737918|Drug|solifenacin|
16155482|NCT01737905|Drug|Epinephrine HFA-MDI (E004)|Single dose 125 mcg/inhalation, 2 inhalations
16155483|NCT01737905|Drug|Placebo-HFA|Single dose 0 mcg/inhalation, 2 inhalations
16155484|NCT01737892|Drug|Arm T Epinephrine Inhalation Aerosol HFA, 125 mcg, 1 inhalation|Epinephrine Inhalation Aerosol HFA, Single dose 125 mcg, 1 inhalation
16155485|NCT01737892|Drug|Arm C-Epinephrine Inhalation Aerosol CFC|Epinephrine Inhalation Aerosol - CFC, Single dose 220 mcg, 1 inhalation
16155486|NCT01737879|Drug|Peginesatide|All participants will receive peginesatide for the first 24 weeks.
16155487|NCT01737879|Drug|Epoetin alfa|All participants converted to epoetin alfa at week 25 for a total of 32 weeks
16155488|NCT01737866|Drug|AMG 423|omecamtiv mecarbil
16155489|NCT01737853|Drug|Ganforti|Enrolled patients will be visiting their clinical site at month 2 and month 3, after starting the study medication; at the end of the third month of treatment, a cross-over maneuver will be indicated; all patients will undergo a follow-up scheme similar to the first period of the study (at month 5 and month 6)
16155490|NCT01737853|Drug|Krytantek|Enrolled patients will be visiting their clinical site at month 2 and month 3, after starting the study medication; at the end of the third month of treatment, a cross-over maneuver will be indicated; all patients will undergo a follow-up scheme similar to the first period of the study (at month 5 and month 6)
16155491|NCT01737840|Drug|Pantoprazole|33 patients
16155492|NCT01737840|Drug|Ranitidine|33 patients
16155493|NCT01737827|Drug|INC280|INC280 will be administered orally and continuously on a twice a day dosing schedule.
16155494|NCT01737814|Drug|Saline|
16155495|NCT01737814|Drug|MST-188|
16155496|NCT01737801|Procedure|Lung function test|Lung function test.
16155497|NCT01737788|Procedure|Cervical occlusion|Women were randomized to receive cervical occlusion or no cervical occlusion in addition to a cervical cerclage (McDonald or Shirodkar cerclage). Cervical occlusion was performed with interrupted or continuous sutures, placed approximately 1 cm deep on each lip, and 0.5 cm apart with a nylon 2-0/3-0 suture.
16155498|NCT01737775|Procedure|Diaphragmatic amplitude measurement|Diaphragmatic amplitude is measured by M Mode ultrasonography the day before and after surgery
16155499|NCT01737762|Biological|HP802-247|HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x106 cells per mL every 14 days.
16155500|NCT01737762|Biological|Vehicle|
16155501|NCT01737749|Device|Neurokeeper stroke detector|Electrophisoloigcal monitoring
16155502|NCT01737736|Device|Neurokeeper stroke detector|Electrophisoloigcal monitoring
16155503|NCT01737723|Device|Neurokeeper stroke detector|Monitoring stroke patients
16155504|NCT01737710|Biological|Fluzone® Intradermal Vaccine|A 0.1mL single-dose, in a latex-free, pre-filled microinjection system with an ultra-fine micro-needle. The active substance is prepared from influenza viruses propagated in embryonated chicken eggs. Fluzone® Intradermal is approved for use in persons 18 through 64 years of age and will be purchased from Sanofi Pasteur, Inc.
16155505|NCT01737710|Biological|Fluzone® (Intramuscular) vaccine|A 0.5 mL single-dose delivered via syringe using single-dose vials. The active substance is prepared from influenza viruses propagated in embryonated chicken eggs. Fluzone® for intramuscular injection is approved for persons 6 months and older and will be purchased from Sanofi Pasteur, Inc.
16155506|NCT01737697|Drug|Zirconium silicate (acute phase)|Randomized oral doses (1.25g, 2.5g, 5g, and 10g) of microporous, fractionated, protonated zirconium silicate administered 3 times (tid) daily with meals for 48 hours.
16155507|NCT01737697|Drug|Zirconium silicate (subacute phase)|Randomized oral doses (1.25g, 2.5g, 5g, and 10g) of microporous, fractionated, protonated zirconium silicate administered once a day prior to the morning meal for 12 days.
16155508|NCT01737697|Drug|Placebo (acute phase)|Randomized to mimic doses of experimental drug administered 3 times (tid) daily with meals for 48 hours during the acute phase.
16155509|NCT01737697|Drug|Placebo ( subacute phase)|Randomized to mimic doses of experimental drug administered once a day prior to the morning meal for 12 days during the subacute phase.
16155510|NCT01737684|Drug|Vibegron|50 mg tablet, oral
16155511|NCT01737671|Procedure|Ommaya Reservoir|Surgical catheter placement into the fourth ventricle of the brain.
16155512|NCT01737671|Drug|Methotrexate|2 mg into fourth ventricle of the brain via the Ommaya Reservoir for 4 days. Each patient will undergo three cycles with at least two weeks between each cycle.
16155513|NCT01737671|Drug|Leucovorin|5 mg/square meter per dose administered every 6 hours by vein or mouth.
16155514|NCT01737658|Other|Exercise Program|Exercise Program for Obese Adolescents
16155515|NCT01737632|Behavioral|Multidimensional Family Therapy (MDFT)|MDFT assesses and intervenes in five domains: 1) Interventions with the adolescent, 2) interventions with the parent, 3) interventions to improve the parent-adolescent relationship, 4) interventions with other family members, and 5) interventions with external systems.
16155516|NCT01737632|Behavioral|Adolescent Residential Treatment|The Adolescent Treatment Program targets the adolescent's abuse or dependency on chemicals while simultaneously treating the comorbid symptomatology found in dual diagnosed patients. These goals are accomplished by using four primary forms of intervention: (1) Chemical Education; (2) Group, Individual and Family Counseling; (3) Twelve Step Work; and 4) Psychotropic Medication for Clinical Symptomatology Comorbid with Substance Abuse.
16155517|NCT01737619|Procedure|Computed Tomography|Undergo PET/CT
16155518|NCT01737619|Drug|Indocyanine Green Solution|Given via superficial and deep cervical injection
16155519|NCT01737619|Other|Laboratory Biomarker Analysis|Correlative studies
16155520|NCT01737619|Procedure|Lymph Node Mapping|Undergo lymph node mapping
16155523|NCT01737606|Device|Fast Cerebral Pulsatility Imaging|Cerebral ultrasonic exploration using with neuro-navigation system : 4 acquisitions on 12 or 6 section planes
16155524|NCT01737593|Drug|Acetaminophen|
16155525|NCT01737580|Drug|resiquimod|
16155526|NCT01737580|Drug|placebo gel|
16155527|NCT01737567|Other|Bright Narrow Band Imaging.|Using Bright Narrow Band Imaging to detect colonic adenomas.
16155528|NCT01737567|Other|White Light Endoscopy|Use of White Light Endoscopy to detect colonic adenomas.
16155529|NCT01737554|Other|Catheter Resistance Monitoring|Weekly measurement of resistance to flow in the lumen(s) of a CVAD with the commercially available Alaris® Syringe Module IV pump. The aim is to identify an increase in resistance greater than normal variation. Inline pressure measurements will be recorded at multiple flow-rates and resistance will be estimated from the gradient of the pressure-flow curve.
16155530|NCT01737541|Drug|Fluoxetine|
16155531|NCT01737541|Drug|Placebo|
16155532|NCT01737528|Procedure|Transcatheter Aortic Valve Replacement|Minimal invasive implantation of a biological prothesis in Aortic Position
16155533|NCT01737515|Other|Abdominal waist and hip circumference|Abdominal waist and hip circumferences are measured clinically with a ruler as part of the standard pre-operative physical examination
16155534|NCT01737502|Drug|Auranofin|Given PO
16155535|NCT01737502|Drug|Sirolimus|Given PO
16155536|NCT01737502|Other|Laboratory Biomarker Analysis|Correlative studies
16155537|NCT01737502|Other|Pharmacological Study|Correlative studies
16155538|NCT01737489|Behavioral|LACE|commercially available LACE program which is administered by computer as daily lessons. The participants will do this program for one month
16155539|NCT01737489|Behavioral|NOOK|will use an electronic reader (Barnes and Noble - NOOK device) to do speech tracking.will do this activity for approximately one hour per day for five days out of seven for a total of four weeks. The speech tracking activity will involve reading approximately two books within the one month time frame. The participants will listen to the book while reading an unabridged book in printed form.
16155540|NCT01737476|Procedure|Transcranial Magnetic Stimulation. PFC|
16155541|NCT01737463|Procedure|Endoscopic snare papillectomy|Endoscopic snare papillectomy (ESP) was performed by using diagnostic or therapeutic duodenoscope. A pancreatic duct stent was or was not inserted immediately after the excision.
16155542|NCT01737450|Drug|BKM120|
16155543|NCT01737437|Drug|group C|0.9% normal saline was applied to trachea and laryngoscope blade
16155544|NCT01737437|Drug|group L|10% Lidocaine was applied to the laryngoscope blade and 0.9% normal saline was applied to the trachea.
16155545|NCT01737437|Drug|group V|0.9% normal saline was applied to the laryngoscope blade and 10% Lidocaine was applied on trachea.
16155546|NCT01737437|Drug|group LV|10% Lidocaine was applied on laryngoscope blade and trachea.
16155547|NCT01737424|Drug|LC28-0126|LC28-0126
16155548|NCT01737424|Drug|Placebo|Placebo
16155549|NCT01737411|Drug|solifenacin|
16155550|NCT01737411|Procedure|cesa/vasa|surgical repair of USL
16155551|NCT01737398|Drug|Inotersen|
16155552|NCT01737398|Drug|Placebo|
16155553|NCT01737385|Procedure|Measurement with O2C|Measurement of microcirculation using O2C light probes.
16155554|NCT01737359|Drug|amdoxovir 300 mg bid|2 x 150 mg capsules bid
16155555|NCT01737359|Drug|amdoxovir 500 mg bid|2 x 250 mg capsules bid
16155556|NCT01737359|Drug|tenofovir DF 300 mg qd|1 x 300 mg tablet once daily
16155557|NCT01737346|Drug|lomustine and procarbazine|1 cycle (4 weeks) includes CCNU 75mg/m2 (D1) and procarbazine 60mg/m2 (D11-D24)by mouth for up to 6 cycles
16155558|NCT01737320|Drug|short-course antibiotic treatment|"On day 7 of appropriate intravenous or oral antibiotic treatment for the bacteremic episode (day 1 is the first day of appropriate antibiotic therapy), patients will be randomized to:
~Intervention group - antibiotic treatment stopped on day 7
~Control group - antibiotic treatment continued for 14 days according to accepted hospital local guidelines."
16155559|NCT01737320|Drug|accepted prolonged antibiotic treatment|
16155560|NCT01737307|Drug|Fluoride varnish|Fluoride Varnish (NaF 5%)
16155561|NCT01737307|Other|Oral Hygiene|Oral hygiene followed.
16155562|NCT01737307|Drug|CPP-ACP|CPP-ACP paste was applied by patient, once daily.
16155563|NCT01737294|Drug|Qutenza exposure|Cutaneous patch
16155564|NCT01737281|Behavioral|Proactive outreach|Proactive contact (mail and phone) offering smoking cessation medications and telephone counseling.
16155565|NCT01737281|Behavioral|Usual care|Usual smoking cessation care from VA clinical staff.
16155566|NCT01737268|Drug|FK949E|Oral tablet
16155567|NCT01737255|Other|Whole body MRI|Individuals will undergo whole body and brain MRI
16155568|NCT01737255|Other|Psychological questionnaires|All recruits will complete questionnaires at 6 time points to assess psychological impact
16155569|NCT01737229|Device|Application of Biodentine™ (RD94), dentin substitute|
16155570|NCT01737216|Drug|Zoledronic acid plus EP/TP|Drug:EP/TP+Zoledronic acid EP(VP-16 100mg/m2 d1-3;DDP 60-75mg/m2 d1) every 4 weeks, for 4-6 cycles TP(PTX 135-175mg/m2 d1;DDP 60-75mg/m2 d1) every 3 weeks, for 4-6 cycles Zoledronic acid 4mg d1 every 3 months until bone metastasis, 4mg d1 every 1 month until progression
16155571|NCT01737216|Drug|EP/TP|Drug:EP/TP EP(VP-16 100mg/m2 d1-3;DDP 60-75mg/m2 d1) every 4 weeks, for 4-6 cycles TP(PTX 135-175mg/m2 d1;DDP 60-75mg/m2 d1) every 3 weeks, for 4-6 cycles
16155572|NCT01737203|Drug|Viagra|50 mg tablet on Day 1 of each period
16155573|NCT01737203|Drug|sildenafil ODT|50 mg tablet on Day 1 of each period
16155574|NCT01737203|Drug|sildenafil ODT|50 mg tablet on Day 1 of each period
16155575|NCT01737190|Other|PEEP guided by Esophageal pressure + Recruitment maneuver|"Upon patient recruitment Esophageal balloon will be inserted and esophageal / pleural pressure will be measured. Thereafter, Inspiratory pressures and PEEP will be adjusted according to well established criteria. Inspiratory pressure and PEEP will be adjusted to achieve the best lung compliance possible while not exceeding transpulmonary end Inspiratory pressure of 25 to 30 cm H2O, and at the same time maintaining a positive transpulmonary end expiarory pressure of not more than 5 cm H2O.
~A recruitment maneuver with application of 40 cm H2O for up to 40 seconds will be performed."
16155615|NCT01736904|Drug|FOLFIRI regimen|irinotecan 180mg/m2 d1,leucovorin 400mg/m2 d1, 5-fluorouracil 400mg/m2 iv, 2.4g/m2 civ 46h, repeated every 2 weeks
16155576|NCT01737177|Drug|Bendamustine, Lenalidomide, Rituximab|"INDUCTION PHASE (COURSE 1-4)
~Bendamustine: 70 mg/m2 on day 2 and 3 every 28
~Lenalidomide: 10 mg/daily on day 1 to 14 of a 28 days course
~Rituximab: 375 mg/m2 on day 1 every 28 days; only for the first cycle in the induction phase will start on day 8
~CONSOLIDATION PHASE (courses 5-6)
~Patients in CR and PR at the end of the induction phase
~Lenalidomide: 15 mg/daily on day 1 to 21 of a 28 days course.
~Rituximab: 375 mg/m2 on day 1 every 28 days
~MAINTENANCE PHASE (courses 7-24)
~Patients in CR or PR at the end of the consolidation treatment with Lenalidomide until disease progression or unacceptable toxicity up to 18 months (from month 7 to month 24)
~- Lenalidomide: 15 mg/daily on day 1 to 21 of a 28 days"
16155577|NCT01737164|Behavioral|Aerobic Exercise|
16155578|NCT01737151|Radiation|stereotactic body radiation therapy|Undergo SBRT
16155579|NCT01737151|Radiation|four fraction split-course SBRT|four fraction split-course SBRT
16155580|NCT01737138|Procedure|RSD|Contrast renal angiography(iodixanol) was performed to localize and assess the renal arteries for accessibility and appropriateness for RSD. Once the anatomy was deemed acceptable, the internally irrigated radiofrequency ablation catheter(Celsius Thermocool,Biosense Webster, Diamond Bar, California) was introduced into each renal artery. then was maneuvered within the renal artery to allow energy delivery in a circumferential, longitudinally staggered manner to minimize the chance of renal artery stenosis. About six to nine ablations at 10 W for 1 min each were performed in both renal arteries. During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm.
16155581|NCT01737138|Drug|medicine|Angiotensin converting enzyme inhibitors, angiotensin receptor antagonist, calcium antagonists, diuretic, beta adrenoceptor blocking agent, statins, platelet aggregation inhibitor, anticoagulants and so on.
16155582|NCT01737125|Radiation|Magnetic Resonance Imaging (MRI)|"spatial high-resolution MRI multiplanar acquisition in T1 and T2 anatomical sequences
~MRI acquisition in movements with dynamic sequences BEAT-IRT ( dynamic TrueFISP)"
16155583|NCT01737112|Drug|99mTc-3PRGD2|For patients in suspicion of lung cancer, single intravenous bolus injection of nearly 11.1 MBq/kg body weight of 99mTc-3PRGD2 on day one of the treatment period, whole-body planar and thoracic SPECT/CT to determine the accumulation of 99mTc-3PRGD2 in the tumors and the other parts of the body.
16155584|NCT01737099|Dietary Supplement|DHA-O|
16155585|NCT01737099|Dietary Supplement|Fish oil|
16155586|NCT01737099|Dietary Supplement|Placebo|
16155587|NCT01737086|Dietary Supplement|Lactobacillus reuteri DSM 17938 and zinc sulphate|
16155588|NCT01737086|Dietary Supplement|placebo|
16155589|NCT01737073|Behavioral|IVR self-management|A course of self-management training that includes 12 education and self-management skill modules presented over 12 consecutive weeks. Participants will be asked to practice each skill daily and report via IVR on their completion of the daily skill practice. They will receive a 10 minute call each week from a nurse care manager to discuss their weekly progress.
16155590|NCT01737073|Behavioral|Opioid monitoring|Monthly automated monitoring of prescription opioid use including pain relief, physical activity, pain-related interference, mood, adverse effects, adherence and satisfaction with treatment.
16155591|NCT01737073|Other|Enhanced usual care|Weekly automated wellness tip and usual clinical care
16155592|NCT01737060|Device|Reverse total shoulder arthroplasty|
16155593|NCT01737034|Other|dietary intervention by varying GI diets|The human study intends to characterise the partitioning of weight gain during refeeding and to affect the catch-up fat phenomenon by the glycemic index (GI) of the diet.
16155594|NCT01737021|Other|Psycho-education|The information given to parents will cover expected reactions that follow a PICU admission; how parents can help their child cope with these reactions; how to recognise warning signs; and sign-posting of appropriate follow-up services (if relevant). There will also be a follow-up telephone call to reinforce the information and to support parents in putting it in to practice, if appropriate.
16155595|NCT01737008|Drug|dacomitinib|Tablets are administered orally or through a G-Tube, and can be taken with or without food.
16155596|NCT01737008|Radiation|Radiotherapy|Intensity modulated radiation therapy (IMRT) delivered using 4 or 6 MV photons. Patients will receive either the standard dose fractionation radiotherapy or accelerated fractionation radiotherapy.
16155597|NCT01737008|Drug|Cisplatin|If selected for this arm, cisplatin will be administered intravenously every three weeks after receiving premedications.
16155598|NCT01736995|Behavioral|Functional Family Therapy|
16155599|NCT01736995|Behavioral|Motivational Enhancement Tx/Cognitive Behavioral Tx|
16155600|NCT01736995|Behavioral|Contingency Management|
16155601|NCT01736982|Behavioral|Contingency Management|Participants earn reinforcement in the form of prizes for breath samples that test negative for cigarette smoking.
16155602|NCT01736982|Other|Standard of Care|Standard smoking cessation counseling
16155603|NCT01736982|Other|Standard of Care|transdermal nicotine replacement [21 mg patches (4 wks), 14 mg (2 wks), 7 mg (2 wks)]
16155604|NCT01736982|Other|Standard of Care|Breath sample monitoring
16155605|NCT01736969|Device|RD047-023|Experimental hydrogel
16155606|NCT01736969|Device|Predicate Device|
16155607|NCT01736956|Procedure|Fetal Aortic Valvuloplasty|Fetuses in the intervention group will undergo in utero balloon aortic valvuloplasty via a transuterine, perventricular approach. Fetuses in the control group will have no invasive intervention while in utero.
16155608|NCT01736943|Drug|Bortezomib|Bortezomib will be given twice a week subcutaneously (under the skin) for two weeks in every 3 week cycle.
16155609|NCT01736943|Drug|Doxil|Doxil or LipoDox will also be given through a venous catheter (inside your vein). Doxil or LipoDox will be given over 60 to 90 minutes on Day 4 of every 21-day cycle.
16155610|NCT01736930|Device|Pump suspension|The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.
16155611|NCT01736917|Drug|Fosaprepitant|Fosaprepitant 150mg IV D3 for acute prophylaxis Fosaprepitant 150mg IV on Day 5 for delayed prophylaxis
16155612|NCT01736917|Drug|Dexamethasone|Dexamethasone 20mg PO daily on D1 and 2 for acute prophylaxis Dexamethasone 4mg PO BID on Days 6 through 8
16155613|NCT01736917|Drug|5HT3|Any 5HT3RA on D1-5; D1, 3 and 5 if palonosetron is used.
16155614|NCT01736904|Drug|wXELIRI regimen|irinotecan 90mg/m2 D1, capecitabine 1000mg/m2 bid po, D1-5,repeated every 7 days
16155617|NCT01736891|Drug|Placebo|Tablets, qd
16155618|NCT01736878|Drug|Sorafenib|
16155619|NCT01736865|Drug|Cholecalciferol|
16155620|NCT01736865|Drug|Placebo|
16155621|NCT01736852|Device|CRB|Labor induction using the CRB
16155622|NCT01736852|Drug|Pitocin|Labor induction using Pitocin
16155623|NCT01736826|Biological|Bloodwork, baseline|36 ml of blood are drawn at baseline (last month of pregnancy for groups P and T2, inclusion for group T1) in order to quantify the following: plasma free DNA concentration, plasma nucleosome concentration, hemoglobin, platelets, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils, D-Dimers, Fibrin monomers, Trophoblast microparticles, Angiogenic marker CD146.
16155624|NCT01736826|Biological|Blood work, Months 1 & 2|36 ml of blood are drawn at 1 & 2 months after inclusion in order to quantify the following: plasma free DNA concentration, plasma nucleosome concentration, hemoglobin, platelets, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils, D-Dimers, Fibrin monomers, Trophoblast microparticles, Angiogenic marker CD146.
16155625|NCT01736826|Biological|Bloodwork, Months -1 to -6|36 ml of blood are drawn at the third, fourth, fifth, sixth, seventh and eight months of normal pregnancy (corresponding to months -1 to -6 before comparative baseline; this group is included in the study early during pregnancy)in order to quantify the following: plasma free DNA concentration, plasma nucleosome concentration, hemoglobin, platelets, leukocytes, polynuclear neutrophils, mean corpuscular volume, monocytes, mean corpuscular hemoglobin, lymphocytes, polynuclear eosinophils, polynuclear basophils, D-Dimers, Fibrin monomers, Trophoblast microparticles, Angiogenic marker CD146.
16155626|NCT01736813|Drug|Maraviroc|Twelve patients with 300 mg/bid
16155627|NCT01736800|Drug|Topotecan|Patients will receive Topotecan intravenous treatment days 2-6 of each 28-day cycle at The Mehthodist Hospital Outpatient Infusion Center.
16155628|NCT01736800|Drug|Temozolomide|Temozolomide is taken on an empty stomach at night and should not be chewed. Patients receive Temozolomide on days 1-5 of a 28-day schedule.
16155629|NCT01736787|Dietary Supplement|Cauliflower Mushroom extract|Cauliflower Mushroom extract (1g/day)
16155630|NCT01736787|Dietary Supplement|Placebo|Placebo (1g/day)
16155631|NCT01736774|Other|Usual care intervention|The usual care intervention will include appropriate primary care as required including medication
16155632|NCT01736774|Other|Physiotherapy treatment|Exercise and manipulative therapy treatment for 10 weeks:The treatment intervention consists of two visits per week for the first four weeks (8 treatments) and one visit per week for the last six weeks (6 treatments)
16155633|NCT01736761|Drug|Darunavir, Ritonavir and Rilpivirine|
16155634|NCT01736748|Behavioral|Sensor based PA intervention|Children will be equipped with a heart rate monitor, a GPS receiver and an accelerometer for collection of heart rate, mobility and physical activity free-living data during a 7-day period. This will provide a 'spatio-behavioural diagnosis' using a map-based interactive web application. This data will be used to developed a tailored plan to promote physical activity in the child's every day environment.
16155635|NCT01736748|Behavioral|Traditional PA counseling|Children will be encouraged to enhance their physical activity levels using traditional behavioral approaches.
16155636|NCT01736735|Drug|CLP|
16155637|NCT01736735|Drug|placebo|
16155638|NCT01736722|Device|Visualase®|The target tumor/lesion will undergo laser therapy using the MRI scan to plan the treatment and ensure proper placement of the laser within the tumor. An MRI (Magnetic Resonance Imaging) is a exam that creates pictures using magnetic rays instead of x-rays. The tumor(s) will then be heated by the laser in an attempt to eliminate their presence. The physician will be able to see and control the temperature of the laser.
16155639|NCT01736709|Biological|2012-2013 trivalent seasonal influenza vaccine|trivalent seasonal influenza vaccine with 0.25 ml ⁄ vial, for infants trivalent seasonal influenza vaccine with 0.5 ml ⁄ vial, for adults and old people
16155640|NCT01736696|Drug|tofacitinib|5 mg BID For 13 days and once on Day 14
16155641|NCT01736696|Drug|tofacitinib|10 mg BID for 13 days and once on Day 14*
16155642|NCT01736696|Drug|tofacitinib|20 mg BID for 13 days and once on Day 14
16155643|NCT01736696|Drug|tofacitinib|30 mg BID for 13 days and once on Day 14
16155644|NCT01736696|Drug|tofacitinib|60 mg tablet once a day (QD) for 14 days
16155645|NCT01736696|Drug|tofacitinib|50 mg tablets two times a day (BID) for 13 days and once on day 14
16155646|NCT01736683|Drug|Sotatercept|Sotatercept is supplied as a lyophilized powder that is reconstituted using Water for Injection (WFI) and administered as a subcutaneous injection (SC) injection by the study staff at the clinical site.
16155647|NCT01736670|Drug|Triamcinolone Acetonide spray|
16155648|NCT01736670|Drug|Triamcinolone acetonide cream|
16155649|NCT01736670|Drug|Alcohol spray|
16155650|NCT01736657|Device|Red blood cell exchange in sickle cell|One Red Blood Cell Exchange using Spectra Optia Apheresis System per enrolled patient
16155651|NCT01736644|Device|Electrocautery|Use of electrocautery in tourniquet and tourniquetless total knee replacement surgery
16155652|NCT01736644|Device|Bipolar sealer Aquamantys|Aquamantys use in tourniquet and tourniquetless total knee replacement.
16155653|NCT01736631|Behavioral|Cognitive behavioural therapy (CBT)|The CBT intervention will follow the model of social phobia by Clark & Wells (Clark & Wells, 1995; Clark, 2005). The main elements of CBT for social phobia include reducing self-focus, dropping safety behaviours, and testing negative cognitions.
16155655|NCT01736605|Procedure|Massage|Patients will receive a daily 20 minute massage in their hospital room on the first 3 days following surgery.
16155656|NCT01736605|Procedure|Massage combined with meditation|Patients will receive a daily 20 minute massage combined with meditation in their hospital room on the first 3 days following surgery.
16155658|NCT01736579|Drug|Immune Globulin Intravenous (Human), 10% (IGIV, 10%)|
16155702|NCT01736215|Drug|Erythropoietin: Observational study|This is an observational study. Participants receiving erythropoietin (dosage and regimen will comply with Thai Food and Drug Administration approval package insert) will be observed.
16155659|NCT01736566|Other|Family History + Whole Genome Sequencing|"Doctors and their patients receive a Genome Report and a Family History report.
~There are two sections of the Genome Report:
~The General Genome Report, which include highly penetrant disease mutations, carrier status for recessive disease, and pharmacogenetic associations.
~The Cardiac Risk Supplement, which contain genetic information found in the genome regarding cardiac diseases or a risk of cardiovascular diseases that can help with the care of the patient.
~Extension Phase: Experimental: Family History + Whole Genome Sequencing
~*In the main study participants are randomized to either the Experimental or Other Arm, in the Extension phase of the study all participants are in the Experimental Arm."
16155660|NCT01736566|Other|Family History Only|Doctors and their patients receive a Family History report.
16155661|NCT01736540|Device|MRI scan|MRI was used to measure both liver and cardiac iron loading (R2 by FerriScan and T2*, respectively).
16155662|NCT01736527|Drug|LE Gel|Single drop of LE Gel 0.5% administered to the study eye on visit 2
16155663|NCT01736514|Drug|febuxostat|oral
16155664|NCT01736514|Drug|Allopurinol|oral
16155665|NCT01736501|Other|Genetics education at baseline|
16155666|NCT01736501|Other|Hypothetical genomic scenarios at follow-up|
16155667|NCT01736488|Drug|Fimasartan|Fimasartan 60mg
16155668|NCT01736488|Drug|Atenolol|Atenolol 50mg
16155669|NCT01736475|Biological|Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method|Pharmacokinetic (PK) evaluation of ADVATE
16155670|NCT01736475|Biological|PEGylated Recombinant Factor VIII|Pharmacokinetic (PK) evaluation of BAX 855
16155671|NCT01736475|Biological|PEGylated Recombinant Factor VIII|Prophylaxis treatment
16155672|NCT01736475|Biological|PEGylated Recombinant Factor VIII|On-demand treatment
16155673|NCT01736462|Drug|Mapracorat|One drop of mapracorat ophthalmic suspension, 3% four times daily, at approximately four hour intervals, for 14 days in both eyes.
16155674|NCT01736449|Drug|Bevacizumab|
16155675|NCT01736436|Drug|Treatment with APG101|Patients will be treated 12 weeks with 100 mg APG101 intravenous weekly
16155676|NCT01736436|Procedure|Bone marrow collection|During the study, bone marrow will be collected 4 times to assess study objectives
16155677|NCT01736436|Procedure|Blood drawings|During the study, blood will be drawn at different time points to assess study objectives
16155678|NCT01736423|Drug|YM060|oral
16155679|NCT01736410|Drug|Trastuzumab, TS ONE, Cisplatin|The initial dose of cisplatin is fixed to be 60 mg/m2 and intravenously administered over 1 hour on day 1 of the cycle. TS-ONE is orally administered consecutive 14-day followed by 7-day rest. The initial standard dose of TS-ONE is determined based on the body surface area tabled below. Trastuzumab is intravenously administered with the loading dose of 8 mg/kg followed by HER2-positive advanced GC 21 years or older No prior regimen HER2 protein HER2/neu detection procedure Tissue from (Gastric) Cancer FISH method IHC method negative positive HER-2 negative HER-2 positive Eligible 0 / 1+ 2+ 3+ HER-2 positive Eligible HER-2 negative iii Protocol S1/CDDP/Her V1.3 dated 21 May 10 maintenance dose of 6mg/kg in day 1 of each cycle. The study treatments are repeated every 3 weeks. Study treatment can continue until PD, but cisplatin can be skipped or discontinued if patients experienced unbearable toxicity which comes from cisplatin.
16155680|NCT01736397|Drug|Ferric Citrate|Dose depends on serum phosphorus levels collected at each study visit.
16155681|NCT01736397|Drug|Placebo|
16155682|NCT01736384|Procedure|Gastric bypass or cholecystectomy|
16155683|NCT01736371|Drug|1% Sevoflurane|In this group of patients, the maintenance of anesthesia is done by 1% sevoflurane + propofol infusion. Propofol infusion is adjusted according to the Bispectral Index.
16155684|NCT01736371|Drug|Propofol|In this group the maintenance of anesthesia is maintained by only propofol infusion.
16155685|NCT01736371|Drug|Sevoflurane|In this group only sevoflurane was used for maintenance of anesthesia. the dose of sevoflurane is adjusted to maintain Bispectral Index within 45 and 55.
16155686|NCT01736358|Drug|Intranasal Ketoralac|15.75 mg of Sprix in each nostril 20 minutes before end of surgery
16155687|NCT01736358|Drug|Placebo|15.75 mg of placebo will be administered in each nostril 20 minutes before the end of surgery
16155688|NCT01736345|Genetic|Genetic Providers|Genetic providers (genetic counselors or nurses) will follow the standardized disclosure protocol for in-person and telephone disclosures whle completing a disclosure flow checklist.
16155689|NCT01736345|Other|Visual Aids|Visual aids targeted to facilitate communication of genetic test results were developed based on our preliminary studies and modified based on our initial pilot study.
16155690|NCT01736345|Other|Post-Disclosure Asessments|Within 72 hours of completion of disclosures, participants will be asked to complete post-disclosure survey again being the option to complete by the aforementioned means.
16155691|NCT01736345|Other|In-person Clinical Follow-Up|Participants who receive their test results in person will meet with a Physician, Physician Assistant or Nurse Practitioneras part of their in person disclosure session. Participants randomiZed to telephone disclosure will be recommendedto schedule an in-person clinical follow-up appointment with a Physician, Physician Assistant or Nurse Practitioner
16155692|NCT01736345|Other|6 Month and 12 Month Assessments|At 6 months and 12 months after disclosure participants will be asked to complete survey assessments.
16155693|NCT01736332|Drug|Vicks VapoInhaler|2 inhalations each nostril every 2 hours for 6 doses on day 1, one dose on morning of day 2
16155694|NCT01736332|Other|Poppy seeds|45 g in liquid at 9 am and 5 pm on day 1
16155695|NCT01736280|Other|Standard of Care|Any evaluation or treatment under this protocol will be based on standard practice as related to the subjects's digestive disorder.These include but are not limited to biobehavioral interventions including bowel retraining, biofeedback, and other lifestyle interventions, all of which have been shown to be beneficial in the treatment of this type of chronic functional bowel disorder.
16155696|NCT01736267|Device|Nucleus 24 (discontinued) and ABI541 Auditory Brainstem Implants (ABI)|Nucleus ABI541 Auditory Brainstem Implant (ABI) surgery followed by device activation, testing, and clinical assessment for five years following surgery.
16155697|NCT01736254|Drug|Evacetrapib|
16155698|NCT01736254|Drug|Gemfibrozil|
16155699|NCT01736241|Drug|LY3053102|
16155700|NCT01736241|Drug|Placebo|
16155701|NCT01736228|Device|DIABECELL|two transplants of 10,000 IEQ/kg DIABECELL (administered at least 12 weeks apart)- total of 20,000 IEQ/kg
16155703|NCT01736202|Biological|fat orally|Oral ingestion of palm oil or canola oil or water at timepoint zero
16155704|NCT01736189|Drug|Adalimumab|Pre-filled syringe, administered by subcutaneous injection
16155705|NCT01736176|Drug|Levodopa-Carbidopa Intestinal Gel|"Levodopa-carbidopa intestinal gel (LCIG) for upper-intestinal infusion is a suspension of levodopa (20 mg/mL) and carbidopa monohydrate (5 mg/mL) in an aqueous gel, administered continuously by a portable pump via a percutaneous endoscopic gastrojejunostomy (PEG-J) tube.
~The rate of LCIG infusion was expected to be within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances over a period of 16 consecutive hours."
16155706|NCT01736176|Procedure|Percutaneous Endoscopic Gastrostomy with Jejunal Extension (PEG-J)|
16155707|NCT01736176|Drug|Levodopa-carbidopa Immediate Release (LC-IR) Tablets|After LCIG initiation, participants could take prescribed oral levodopa-carbidopa immediate or continuous release (i.e., oral LC prescribed by the investigator) for nighttime use.
16155708|NCT01736163|Drug|Thyrogen|0.9 mg IM, administrated for 2 consecutive days
16155709|NCT01736163|Drug|131I|28 mCi or ≥ 1.036 GBq.
16155710|NCT01736163|Other|Thyroid Hormone Withdrawal|Stop taking hormone therapy
16155711|NCT01736150|Drug|Placebo|"Starting dose of 1 tablet (800mg), three times per day (2.4g/day)with meals.
~If serum phosphorus is higher than 5.5 mg/dL on Visit 3, 4, or 5, then dose increased by one additional tablet (800 mg). Three times daily with meals."
16155712|NCT01736150|Drug|Sevelamer carbonate|"Starting dose 1 tablet (800 mg), three times per day (2.4 g/day) with meals.
~If serum phosphorus is higher than 5.5 mg/dL on Visit 3, 4, or 5, then dose increased by one additional tablet(800mg).Three times daily with meals."
16155713|NCT01736137|Other|Six minute walk test|If patients meet the criteria of the study, their data will be collected and will be interviewed to fill the Minnesota Living with Heart Failure Questionnaire (MLHFQ). They then will be taken to the hallway to perform the six minute walk test monitored with a heart rate monitor (Polar RS800 CX). After the test there will be a break of 20 to 30 minutes before repeating the walk test. During rest time, the patient will answer the general health survey questionnaire: Medical Outcome Study 36-item Short-Form Health Survey (SF-36).
16155714|NCT01736124|Other|computerized cognitive training|A variety of computer games tailored to address their personal cognitive deficits.
16155715|NCT01736124|Other|control games|A variety of computer games that are engaging but not designed to enhance cognitive skills
16155716|NCT01736111|Behavioral|one way text|
16155717|NCT01736111|Behavioral|Personal feedback|
16155718|NCT01736098|Other|Energy Flux Exercise Intervention|Comparison of high, medium and low energy flux groups with all groups matching energy intake and expenditure
16155719|NCT01736085|Behavioral|Telephone counseling|Telephone counseling is conducted in the appropriate language (English and Spanish) by veteran counselors at the California Smokers' Helpline. Subjects will receive free proactive telephone counseling to help them set up quit smoking plans. The content of the counseling addresses both behavioral and cognitive issues that the individual smoker faces in his/her attempt to quit. It includes a 30-minute comprehensive pre-quit session (motivation, planning, setting of a quit date and the discussion of quitting aids including nicotine patch use) plus up to four 10-minute proactive follow-up calls. The counseling protocol has several distinguishing features: proactive follow-up counseling calls, a manualized (i.e., semi-structured) protocol and relapse-sensitive scheduling
16155720|NCT01736085|Behavioral|Voucher|"Subjects will receive a voucher for nicotine patches.
~Subjects randomized into the voucher condition will receive a voucher that can be exchanged for two weeks' worth of free starter kit nicotine patches by calling a dedicated phone number (Quit Boost). The voucher will be mailed the day after the screening intake. Subjects who smoke 11 or more cigarettes per day will receive 21 mg patches; smoke 10 or less per day will receive 14 mg patches. Subjects will be encouraged to start using these patches on their quit date."
16155721|NCT01736085|Drug|Nicotine patches|Subjects will receive nicotine patches directly sent to their home. Subjects randomized into the patch condition will receive two weeks' worth of free starter kit nicotine patches directly. The patches will be mailed directly to their home the day after screening intake. Subjects who smoke 11 or more cigarettes per day will receive 21 mg patches; smoke 10 or less per day will receive 14 mg patches. Subjects will be encouraged to start using these patches on their quit date.
16155722|NCT01736072|Procedure|Standard Laparoscopic Surgery|The research subjects will be randomized to Standard Laparoscopic Surgical procedure to resect their Rectal Cancer.
16155723|NCT01736072|Procedure|Robotic Assisted Laparoscopic Surgery|The research subjects will be randomized Robotic Assisted Laparoscopic Surgical procedure to resect their Rectal Cancer.
16155724|NCT01736059|Drug|CD34+ bone marrow stem cells intravitreal|
16155725|NCT01736046|Radiation|CT Enterography|"Diagnostic CT Enterography Scan (CTE)
~Subjects will have their scheduled diagnostic CTE scan done according to St. Paul's Hospital radiology department standard procedures. Subjects will be randomly assigned to undergo a low dose CT Enterography scan either before or after the diagnostic scan. The radiologists who are blinded to the technique used will then interpret the scans to look for signs of Crohn's disease. The low dose scan will be compared to the standard scan in terms of it's ability to detect signs of Crohn's disease."
16155726|NCT01736033|Drug|Tamsulosin|1 tablet(0.2mg) orally q.d.
16155727|NCT01736033|Drug|Finasteride|1 tablet(5mg) orally q.d.
16155728|NCT01736033|Drug|Placebo|1 tablet(0.2mg) orally q.d.
16155729|NCT01736020|Drug|Dexmedetomidine|A low dose of dexmedetomidine is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
16155730|NCT01736020|Drug|Propofol|A low dose of propofol is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
16155731|NCT01736020|Drug|Ketamine|A low dose of ketamine is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
16155732|NCT01736020|Drug|Nitrous Oxide|A low dose of nitrous oxide is used during scanning after dose piloting outside the scanner for memory effects and tolerability.
16155733|NCT01736020|Drug|Placebo|Placebo
16155734|NCT01736007|Device|308-nm excimer laser to alopecia patch|MED dosing as per protocol with beginning at 50 mJ/cm2 below MED with increases by 50mJ/cm2 every 2 treatments as tolerated. Maximum dosing would be 850mJ.Treatments given twice a week for 12 weeks.
16155838|NCT01735149|Dietary Supplement|Placebo|Placebo (34.5g/day)
16155839|NCT01735136|Dietary Supplement|InSan Bamboo Salt|InSan Bamboo Salt (10g/day)
16155735|NCT01736007|Device|Liquid light guide tip on laser|Sham treatment involves placement of liquid light guide tip developed by the laser company which attaches to the end of the hand wand and blocks the laser light from passing to the target. Patients are treated twice a week for 12 weeks.
16155736|NCT01735994|Behavioral|Healthy Weight|Eating Disorder Prevention Program for Athletes
16155737|NCT01735994|Other|Brochure|Brochure on the Female athlete triad
16155738|NCT01735981|Other|Video game exercise using Dance Dance Revolution|use of the video-game, Dance, Dance Revolution as an exercise to improve gait and balance
16155739|NCT01735981|Other|hand-held video game|hand-held video games
16155740|NCT01735968|Drug|ST571 + BYL719|Evaluable patients must meet the minimum treatment and safety evaluation requirements of the study. Patients will be treated until they experience progression of disease, withdraw consent, or experience unacceptable toxicity. One study cycle equals 28 days.
16155741|NCT01735955|Drug|AMN107|AMN107 (nilotinib)
16155742|NCT01735942|Drug|Ingenol mebutate|
16155743|NCT01735942|Procedure|cryotherapy|
16155744|NCT01735929|Procedure|Neck Liposuction and Ultrasound Treatment|
16155745|NCT01735929|Procedure|Sham Treatment|
16155746|NCT01735916|Device|CRT-P Implant|"The Medtronic Consulta CRT-P (models C3TR01, C4TR011) dual chamber implantable pacemaker with cardiac resynchronization therapy (CRT-P) is a multi-programmable cardiac device that monitors and regulates the patient's heart rate by providing single or dual chamber rate-responsive bradycardia pacing, and sequential biventricular pacing.
~The device senses the electrical activity of the patient's heart using the electrodes of the implanted atrial and right ventricular leads. It then analyzes the heart rhythm based on selectable detection parameters. The device responds to bradyarrhythmias by providing bradycardia pacing therapy.
~Simultaneous or sequential biventricular pacing is used to provide patients with cardiac resynchronization therapy. The device also provides diagnostic and monitoring information that assists with system evaluation and patient care."
16155747|NCT01735916|Device|CRT-P OFF|Device programmed to minimal pacing at 40 beats/minute. Device and arrhythmia diagnostics may remain enabled.
16155748|NCT01735903|Procedure|Arm A - Non-Diabetic, Gait and Balance|"Arm A will enroll patients WITHOUT diabetes, but with peripheral neuropathy and lower limb pain, paresthesia, gait disturbances, or motor weakness and will follow the same protocol except the subject will NOT participate in blood flow testing performed at Colorado State University, and therefore do not include the inclusion/exclusion criterion that are specifically related to the blood flow assessment.
~Subjects may have any combination of lower limb nerve decompression surgery of the listed surgical sites with or without the addition of Soleal Sling Decompression. Soleal Sling Decompression surgical procedure will require the use of a thigh tourniquet."
16155749|NCT01735890|Drug|CJ Amlodipine/Valsartan 10/160mg Novartis Exforge 10/160mg|single dose
16155750|NCT01735877|Other|Mirror therapy|During the mirror practices, patients were seated close to a table on which a mirror (35×35cm) was placed vertically. The practice consisted of non paretic-side wrist and finger flexion and extension movements while patients looked into the mirror, watching the image of their noninvolved hand, thus seeing the reflection of the hand movement projected over the involved hand. Patients could see only the noninvolved hand in the mirror; otherwise, the noninvolved hand was hidden from sight. During the session patients were asked to try to do the same movements with the paretic hand while they were moving the non paretic hand.
16155751|NCT01735877|Other|Control group|The control group performed the same exercises for the same duration but used the nonreflecting side of the mirror in such a way that the paretic hand was hidden from sight. The same therapist delivered the control therapy to the patients. Both the treatment and the control group received limb activation.
16155752|NCT01735864|Drug|Indirubin 200μg/g|"Dosage form: Ointment
~Dose(s): Each gram of ointment containing 200 μg of indirubin
~Dosing schedule: apply 0.5 g of ointment per 10 x 10 cm psoriatic lesion twice daily"
16155753|NCT01735864|Drug|Indirubin 100 μg/g|"Dosage form: Ointment
~Dose(s): Each gram of ointment contains 100 μg of indirubin
~Dosing schedule: apply 0.5 g of ointment per 10 x 10 cm psoriatic lesion twice daily"
16155754|NCT01735864|Drug|Indirubin 50 μg/g|"Dosage form: Ointment
~Dose(s): Each gram of ointment contains 50 μg of indirubin
~Dosing schedule: apply 0.5 g of ointment per 10 x 10 cm psoriatic lesion twice daily"
16155755|NCT01735864|Drug|Indirubin 10 μg/g|"Dosage form: Ointment
~Dose(s): Each gram of ointment contains 10 μg of indirubin
~Dosing schedule: apply 0.5 g of ointment per 10 x 10 cm psoriatic lesion twice daily"
16155756|NCT01735851|Drug|Thoracic epidural analgesia|
16155757|NCT01735851|Procedure|Bilateral Paravertebral block|
16155758|NCT01735825|Device|paclitaxel-coated balloon catheter with Iopromide coating|Patients with coronary in-stent restenosis treated by drug eluting paclitaxel-coated balloon catheter
16155759|NCT01735825|Device|drug eluting stent with everolimus|Patients with coronary in-stent restenosis treated by drug eluting stent with everolimus
16155760|NCT01735825|Device|seal-wing paclitaxel-eluting balloon catheter|Patients with coronary in-stent restenosis treated by seal-wing paclitaxel-eluting balloon catheter
16155761|NCT01735812|Device|IceSense3 system|The IceSense3™ is a modern cryosurgical device that was designed by IceCure Medical for a variety of applications.
16155762|NCT01735786|Device|EndoClot|EndoClot hemostat is applied immediately after EMR to achieve hemostasis.
16155763|NCT01735747|Radiation|Radiotherapy|WBRT was given five times a week at 2 gray (Gy)/d until the whole brain radiotherapy dose reached 40 gray. The patients were given concurrent temozolomide (75mg/m2, orally) daily during radiotherapy until the end of radiotherapy.
16155764|NCT01735747|Drug|nedaplatin|nedaplatin (80mg/m2 i.v., day 1), 28 day schedule, performed four weeks after radiotherapy.A maximum of six cycles were applied.
16155765|NCT01735747|Drug|vincristine|vincristine (1.4mg/m2 i.v., day 1)28 day schedule,performed four weeks after radiotherapy.A maximum of six cycles were applied.
16155766|NCT01735747|Drug|Temozolomide|Temozolomide (200mg/m2 orally, days 1-5, Each cycle was 4 weeks ), performed four weeks after radiotherapy. A maximum of six cycles were applied.
16155767|NCT01735734|Device|Air cooling to CM site|
16155840|NCT01735136|Dietary Supplement|Placebo|Placebo (10g/day)
16155841|NCT01735123|Dietary Supplement|dietary intervention|hydrolyzed vs. nonhydrolyzed infant formula
16155842|NCT01735110|Procedure|transfemoral intervention (TFI)|
16155843|NCT01735110|Procedure|Transradial intervention|
16155768|NCT01735721|Procedure|Open Sinus Lift|"A crestal incision was made on the mucosa of the edentulous ridge. The flap was elevated carefully and extended labially to expose the bone. A vertical releasing incision was made in the mesial end of the flap as needed. The mucoperiosteal flap was extended to expose the alveolar ridge and the lateral wall of the maxillary sinus. Then, a window was prepared using the piezoelectric device (Mectron, Italy); the Schneiderian membrane was then elevated conservatively according to the technique described by Vercellotti (2001).
~The sinus membrane was meticulously detached and pushed superiorly to allow for the placement of bone graft material."
16155769|NCT01735708|Behavioral|HIVPASS|
16155770|NCT01735708|Other|Health Education|
16155771|NCT01735682|Device|Whole body vibration|The vibration frequency and amplitude used will be 30-40 Hz and 1mm, respectively. The total exposure to the vibration stimulation is 4 minutes.
16155772|NCT01735682|Behavioral|Conventional exercise|The conventional exercise training involves upper limb and lower limb strengthening exercises using sandbags.
16155773|NCT01735682|Behavioral|Control|The control treatment involves exercises of the upper limbs.
16155774|NCT01735669|Drug|Remifentanil|
16155775|NCT01735669|Drug|Nitrous Oxide|
16155776|NCT01735656|Device|Resolute stents|zotarolimus-eluting Resolute stents made by Medtronic Vascular, Inc (http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/Recently-ApprovedDevices/ucm294951.htm).
16155777|NCT01735643|Device|interactive videogame Wii Fit Plus|Use of the interactive videogame Wii Fit Plus für 12 weeks.
16155778|NCT01735643|Other|waiting|waiting for 12 weeks
16155779|NCT01735630|Drug|ELND005|
16155780|NCT01735630|Drug|Placebo|
16155781|NCT01735617|Drug|Hydrocortisone Modified Release Capsules|Patients with congenital adrenal hyperplasia standardised on conventional therapy is enrolled onto the study and treatment is switched to Chronocort, initially for pharmacokinetic assessment followed by longer-term biochemical and efficacy assessment
16155782|NCT01735604|Biological|anti-CD20-CAR vector-transduced autologous T cells|anti-CD20-CAR vector-transduced autologous T cells
16155783|NCT01735604|Other|genetically engineered lymphocyte therapy|genetically engineered lymphocyte therapy
16155784|NCT01735591|Dietary Supplement|Placebo|Placebo, 1 capsule a day from inclusion until the date of liver transplantation
16155785|NCT01735591|Dietary Supplement|Probiotic|Capsules with 3x10^9 colony forming units of: Lactococcus lactis PB 411 (50%), Lactobacillus casei PB 121 (25%), Lactobacillus acidophilus PB 111 (12,5%), Bifidobacterium bifidum PB 211 (12,5)
16155786|NCT01735539|Dietary Supplement|15g EAA bolus|Oral; in aqueous solution
16155787|NCT01735539|Dietary Supplement|4 x 3.75g Mixed EAA Pulses|Oral; in aqueous solution
16155788|NCT01735539|Dietary Supplement|15g EAA Bolus supplemented with 3g Arginine|Oral; in aqueous solution
16155789|NCT01735513|Device|Intra-aortic embolic protection management system; Embol-X|"The Embol-X system is positioned within the aorta to capture emboli, such as blood clots or tissue fragments, to prevent them from traveling through a patient's bloodstream during TAVI. The EMBOL-X system features a small, expandable, polyester-mesh filtration system that is placed inside the aorta above the aortic clamp during open-heart surgery or transaortic TAVI procedures, where it captures particles in the bloodstream that otherwise might have remained in the patient's circulatory system. A recent presentation characterized the removal of aortic cross-clamps as creating in some patients embolic showers which have the potential to cause neurocognitive complications, stroke and other organ damage. In documented procedures, 97% of EMBOL-X system filters showed detectable captured embolic matter, visible proof that the system is removing potentially dangerous emboli from the bloodstream."
16155790|NCT01735487|Other|Own Brand cigarette|Smoke, 15 puff of, Own Brand cigarettes;
16155791|NCT01735487|Other|one high 2,4% nicotine|Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine
16155792|NCT01735487|Other|original 7,4 mg nicotine|Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine
16155793|NCT01735487|Other|nicotine free|smoke, 15 puff, of electronic cigarette nicotine free
16155794|NCT01735487|Other|Ego 9mg|smoke, 15 puff, of electronic cigarette Ego 9 mg
16155795|NCT01735474|Other|Manual technique|"A manual technique is employed in the intervention group based on passive movement and stretching of the respiratory system.
~The manual technique includes:
~stretching of diaphragm. Mobilization. Potentiation of the respiratory muscles."
16155796|NCT01735474|Other|Placebo|Usual care
16155797|NCT01735461|Dietary Supplement|Calcium Carbonate|There is a regimen for dietary supplement intake that will be provided to study participants.
16155798|NCT01735448|Other|Focus group|"Initially, ten focus groups with an average sample size of 5-7 participants each will be performed in two communities within South Australia, one being Adelaide and the other Murray Bridge, this includes focus groups held with healthcare workers.
~The proposed focus groups will be conducted by experienced mediators who have undertaken Aboriginal cultural awareness training and have experience in qualitative research methods. Both mediators have also been involved in all aspects of project development and consultation with Aboriginal Elders and key stakeholders since its conception.
~We will be using topic guides (reviewed by Aboriginal Elders and researchers) that will be semi-structured with open-ended questions designed to encourage group discussion around smoking cessation and the use of pharmacotherapies in particular, in addition to other objectives identified during the consultation phase of this research."
16155799|NCT01735448|Other|One-on-one interviews|One-on- one interviews will be held with both medical clinicians and key stakeholders and will be conducted by existing TQEH (The Queen Elizabeth Hospital), Clinical Practice Unit employees, experienced in qualitative research. Informed consent will be required and the interview will be audio taped to allow analysis of the qualitative data. All interviews will remain anonymous, unless the interviewee prefers to be named. In this case, they will be named in the acknowledgement section of all publications and presentations. Moderator guides have been developed and reviewed in the same process undergone by the focus group moderator guides
16155844|NCT01735097|Dietary Supplement|Vitamin E|Vitamin E (200 mg, soft capsule)
16155845|NCT01735097|Dietary Supplement|Nigella sativa|Nigella sativa (200 mg, soft capsule)
16155846|NCT01735097|Dietary Supplement|Placebo|Placebo (refined oil in soft capsule with same color and size like that contains N. sativa)
16155959|NCT01734343|Device|HOYA iMics Y-60H|same-day bilateral cataract surgery with implantation of intraocular lens HOYA iMics Y-60H in one eye
16155800|NCT01735448|Other|Survey|A four page survey will be administered to all focus group and interview participants in addition to select cohorts including tobacco related special interest groups of the Thoracic Society of Australia and New Zealand (TSANZ). The survey will include demographic data, smoking history and current smoking status (questions related to smoking for current tobacco users include the Fagerstrom test for nicotine dependence, multiple Likert scales for cravings, motivation to quit, confidence etc.) and Likert scales examining perceptions, attitudes and knowledge about tobacco use, cessation, prevention, health and research in the Aboriginal setting.
16155801|NCT01735435|Other|Indirect Calorimetry|"The tight calorie group received calories with an energy goal determined by repeated REE measurements using indirect calorimetry.
~IC measurements:after a fasting period of at least 6 hours at three time periods : on admission to the study,between 24-48 hours following surgery and on the 7th day of the study.Measurements were performed by an experienced nurse or dietician,the device was automatically calibrated before each measurement and the REE was recorded after 15 minutes."
16155802|NCT01735422|Drug|r-hFSH|Daily r-hFSH treatment will be administered subcutaneously at a starting dose according to the site's standard practice from Day 3-5 of menstrual cycle up to follicular development or 28 days. Dose can be altered according to ovarian response (reduced to 75 IU/day; increased to 225 IU/day).
16155803|NCT01735422|Drug|r-hLH|Ovulation triggering will be performed using a single injection of r-hLH injection subcutaneously at a dose of 825 or 2750 or 5500 or 11,000 or 22,000 IU as soon as follicles satisfy the criteria for follicular development, that is at least 1 follicle with diameter >= 18 mm, not more than 5 follicles with diameter >= 15 mm and with E2 levels less than 9000 picomoles per liter (pmol/L).
16155804|NCT01735422|Drug|u-hCG|Ovulation triggering will be performed using a single injection of 5000 IU of u-hCG as soon as follicles satisfy the criteria for follicular development, that is at least 1 follicle with diameter >= 18 mm, not more than 5 follicles with diameter >= 15 mm and with E2 levels less than 9000 picomoles per liter (pmol/L).
16155805|NCT01735409|Drug|ABX + DDP|ABX 260 mg/m2 day 1 + DDP 75mg/m2 day 1
16155806|NCT01735409|Drug|ABX + DDP|ABX 140 mg/m2 day 1,8 + DDP 75mg/m2 day 1
16155807|NCT01735409|Drug|ABX + DDP|ABX 100 mg/m2 day 1,8,15 + DDP 75mg/m2 day 1
16155808|NCT01735396|Drug|Abiraterone Acetate|Abiraterone acetate 1000 mg orally daily (supplied as four 250 mg tablets) and prednisone 5 mg orally twice daily
16155809|NCT01735383|Drug|Etodolac Tablets USP 500mg|500 mg tablet once a day
16155810|NCT01735383|Drug|Etodolac Tablets USP 500 mg|500 mg tablet once a day
16155811|NCT01735370|Drug|Etodolac Tablets USP 500mg|500 mg tablet once a day
16155812|NCT01735370|Drug|Etodolac Tablets USP 500 mg|500 mg tablet once a day
16155813|NCT01735357|Dietary Supplement|EPA-rich triacylglycerol oil|
16155814|NCT01735357|Dietary Supplement|Placebo - olive oil (BP specification)|
16155815|NCT01735357|Dietary Supplement|DHA-rich triacylglycerol oil|
16155816|NCT01735344|Drug|Lisinopril Tablets 40 mg|40 mg tablet once a day
16155817|NCT01735344|Drug|Lisinopril|40 mg tablet once a day
16155818|NCT01735318|Drug|Lisinopril Tablets 40 mg|40 mg tablet once a day
16155819|NCT01735318|Drug|Lisinopril|40 mg tablet once a day
16155820|NCT01735292|Device|Automatic Respiration Transfer System- Timer|
16155821|NCT01735279|Drug|Omega 3|Each fish oil capsule contained 210.99 mg of EPA and 129.84 mg of DHA.
16155822|NCT01735279|Drug|Placebo|mineral oil + food dye #2 (simulating the colour of essential fatty acids); 1000 mg of mineral oil per capsule
16155823|NCT01735266|Other|Air colonoscopy|Colonoscopy will be performed with conventional air insufflation during colonoscope insertion.
16155824|NCT01735266|Other|Water exchange colonoscopy|Water exchange method (The air pump was turned off before colonoscopy. During colonoscope insertion, residual air in lumen was suctioned and 37°C water was infused into lumen to obtain lumen visualization) was used in whole or left colon. Air was insufflated until cecum was reached or appendix opening was seen.
16155825|NCT01735253|Procedure|laparoscopic roux en Y gastric bypass / open duodenojejunal bypass|routine GBP with 80cm roux and biliopancreatic limb
16155826|NCT01735240|Drug|AZD5069|AZD5069 15 mg (3x5 mg capsules) single administration
16155827|NCT01735240|Drug|Ketoconazole|Ketoconazole 400 mg (2x200 mg tablets)
16155828|NCT01735227|Drug|omeprazole|all patients taking clopidogrel loading dose 300mg + aspirin 300mg and the subsequent maintenance dose of clopidogrel 75mg(1 year) + aspirin 300mg(1 month)+ aspirin 100mg(long-term)and omeprazole group taking omeprazole 20mg/d
16155829|NCT01735227|Drug|Pantoprazole|On the day of admission , all patients taking clopidogrel loading dose 300mg + aspirin 300mg and the subsequent maintenance dose of clopidogrel 75mg + aspirin 300mg and omeprazole group taking omeprazole 20mg / d , pantoprazole group taking pantoprazole 20mg / d. Respectively, on the day of admission ( before medication ) , medication for 12-24 hours , medication after 72 hours , 30 days , each taken early morning fasting venous blood again , measuring AA 、ADP - induced platelet aggregation . And selected 30 days , 6 months and 12 months to record the patient's clinical adverse events ( including death , myocardial infarction , and any revascularization , stent thrombosis , recurrent angina , rehospitalization
16155830|NCT01735214|Drug|Prostaglandin Analogue -Containing IOP-Lowering Therapy|Patients with POAG or OHT on current IOP-lowering therapy who are prescribed a prostaglandin analogue -containing IOP-lowering therapy by the physician. The decision to prescribe a change in IOP-lowering therapy lies with the physician according to their standard practice.
16155831|NCT01735201|Drug|AGN-199201 Dose A|AGN-199201 Dose A applied once or twice daily to the face for 28 days.
16155832|NCT01735201|Drug|AGN-199201 Dose B|AGN-199201 Dose B applied once or twice daily to the face for 28 days.
16155833|NCT01735201|Drug|AGN-199201 Dose C|AGN-199201 Dose C applied once or twice daily to the face for 28 days.
16155834|NCT01735201|Drug|AGN-199201 Vehicle|AGN-199201 Vehicle applied once or twice daily to the face for 28 days.
16155835|NCT01735175|Drug|LA-EP2006|Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
16155836|NCT01735175|Drug|Neulasta®|Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle pegfilgrastim is injected s.c. post chemotherapy application.
16155837|NCT01735149|Dietary Supplement|Kochujang Pills|Kochujang Pills (34.5g/day)
16155847|NCT01735084|Biological|Prevenar13|"The vaccine is a ready to use homogeneous white suspension for intramuscular injection, supplied as a pre-filled syringe.
~Active ingredients
~Each 0.5 mL dose contains:
~2.2 μg of pneumococcal purified capsular polysaccharides for serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F and 23F 4.4 μg of pneumococcal purified capsular polysaccharides for serotype 6B. Each serotype is individually conjugated to non-toxic diphtheria CRM197 protein and adsorbed on aluminium phosphate (0.565 mg)."
16155848|NCT01735084|Biological|Synflorix|The 10-valent vaccine contains 1 µg of purified capsular polysaccharide of pneumococcal serotypes 1, 5, 6B, 7F, 9V, 14, and 23F conjugated to protein D, 3 µg of serotype 4 conjugated to protein D, 3 µg of serotype 18C conjugated to tetanus toxoid and 3 µg of serotype 19F conjugated to diphtheria toxoid.
16155849|NCT01735071|Drug|bevacizumab and trabectedin|Arm A: bevacizumab (15 mg/kg) given as 1 hour infusion will be followed by trabectedin (1.1 mg/sqm) 3 hour iv infusion; to be repeated every 21 days until progression, unacceptable toxicity, patient or physician decision to discontinue, or death patients
16155850|NCT01735071|Drug|bevacizumab, trabectedin and carboplatin|"Arm B: cycle 1- 6, bevacizumab given as 1 hour infusion will be followed by carboplatin AUC 4 and trabectedin 3 hour iv infusion.
~Cycle 7- end of treatment, bevacizumab given as 1 hour infusion will be followed by trabectedin 3 hour iv infusion.
~Patient enrolled in arm B will receive (cycle 1-6): trabectedin 0.8 mg/m2 ,carboplatin AUC 4 day 1 every 28 days and bevacizumab 10 mg/kg iv on day 1 and day 15.
~From cycle 7 to disease progression, unacceptable toxicity, patient or physician decision to discontinue, or death patients will receive bevacizumab 15 mg/kg iv and trabectedin 1.1 mg/m2 day 1 every 21 days"
16155851|NCT01735058|Drug|Sodium Hyaluronate|Ultrasound guided injection of sodium hyaluronate; Fermathron ™, 20 mg/2ml of Sodium Hyaluronate, 3 weekly injections.
16155852|NCT01735058|Drug|Normal saline|Ultrasound guided injection of 0.9% normal sodium hyaluronate line solution, at 2 mL/syringe, 3 weekly injections.
16155853|NCT01735045|Device|Lagado LSH (mangofilcon A) Soft (hydrophilic) Contact Lens|Daily Wear
16155854|NCT01735045|Device|Benz 3GX (hioxifilcon B) Soft (hydrophilic) Contact Lens|
16155855|NCT01735019|Drug|Administration of remifentanil with TCI system|A given effect site concentration of remifentanil would be administered to subjects using TCI system. According to biased coin design, the given concentration of remifentanil is determined according to success or failure of just previously enrolled patient. If the former patient did not cough during anesthetic emergence at a given concentration (success), the next patient will be randomly allocated into the same concentration of remifentanil with 18/19 of probability or the lower concentration of remifentanil by 0.4 ng/ml with 1/19 of probability. If the former patient coughed during anesthetic emergence (failure), the next will be automatically allocated into the higher concentration of remifentanil by 0.4 ng/ml.
16155856|NCT01735006|Biological|HPV Vaccine|3 doses at month 0,1 and 6
16155857|NCT01735006|Biological|HEV vaccine|3 doses at month 0,1 and 6
16155858|NCT01734993|Drug|Tocilizumab|Participants will receive TCZ 162 milligrams (mg) SC injection once a week.
16155859|NCT01734980|Procedure|Endobronchial Ultrasound|The samples will be divided as 2 groups for comparison. Group A is the group of samples where we apply negative pressure syringe for needle suction. Group B is where no suction will be applied after needle insertion.
16155860|NCT01734967|Device|needle based CLE|"EUS-nCLE will be performed after EUS identification of the pancreatic tumor / lymph node / liver metastasis:
~The confocal microprobe will be preloaded in a 19G FNA needle as previously described and advanced into the lesion under EUS guidance.
~nCLE examination will follow after the intravenous administration of the contrast agent (2.5 ml fluorescein 10%).
~Image data will be stored digitally for offline analysis."
16155861|NCT01734967|Procedure|EUS-FNA|Endoscopic ultrasound (EUS) is an established tool in pancreatic masses used both for diagnosis, but also for staging purposes. Additionally, EUS enables guided fine needle aspiration (FNA), which is currently recommended as the first-line procedure whenever a pathological diagnosis is required.
16155862|NCT01734954|Procedure|Sciatic nerve anesthesia blockade at bifurcation.|A proximal and distal initial scan and define the site to block the bifurcation. A puncture with an insulated needle guided by ultrasound and injection of levobupivacaine circumferential in 0.5% and a total volume of 20 mL.
16155863|NCT01734954|Procedure|Sciatic nerve blockade 2 cm beyond the bifurcation|A proximal and distal initial scan and define the sites to block: tibial and peroneal nerves separate distal 2 cm from the bifurcation site. A puncture with an insulated needle guided by ultrasound and injection of levobupivacaine circumferential in 0.5% 10 mL tibial nerve and 10 mL to the peroneal nerve.
16155864|NCT01734954|Drug|Levobupivacaine 0.5%: 20 ml|Levobupivacaine is a local anesthetic that is commonly use for anesthesia nerve blockade.
16155865|NCT01734954|Device|Portable Ultrasound Machine: Sonosite, M-Turbo, Bothell, WA|An ultrasound machine is a device that is widely used for the correct placement of the local anesthetic for anesthesia nerve blockade.
16155866|NCT01734954|Device|Insulated Needle, (Stimuplex; Braun, Melsungen, Germany)|This is a specific kind of needle that is widely used for anesthesia nerve blockade.
16155867|NCT01734954|Drug|supplemental oxygen|supplemental oxygen during the block and/or during surgery
16155868|NCT01734954|Drug|Midazolam|Intravenous midazolam for sedation during the block and/or during surgery
16155869|NCT01734954|Drug|Intravenous analgesics|Intraoperative administration intravenous of dipyrone 30-50 mg/Kg and or intravenous ketoprofen 100 mg or diclofenac 75 mg or ketorolac 30 mg
16155870|NCT01734954|Procedure|Saphenous nerve block|Depending on sensitive territory committed by the type of surgery suprapatellar saphenous nerve block guided by ultrasound with 100 mm Stimuplex needle and injection of levobupivacaine 0.5% (total volume: 5 ml).
16155871|NCT01734941|Drug|TSO|There is evidence of a relationship between ASD symptomatology and immune dysfunction suggests that immunomodulatory treatments effective in other autoimmune disorders might be investigated in ASD, including Trichuris Ova Suis (TSO), a helminth porcine whipworm
16155872|NCT01734941|Drug|Placebo|
16155873|NCT01734928|Drug|Pomalidomide|Pomalidomide 4 mg will be taken orally on Days 1-14 of a 21-day cycle.
16155874|NCT01734928|Drug|Bortezomib|Bortezomib 1.3 mg/m2 will be administered subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on Days 1, 8 of 21 days for cycle 9 and onward until disease progression.
16155960|NCT01734343|Device|PhysIOL microAY|same-day bilateral cataract surgery with implantation of intraocular lens PhysIOL microAY in one eye
16155961|NCT01734330|Behavioral|Cognitive behavioral therapy in group|
16155875|NCT01734928|Drug|Dexamethasone|Dexamethasone 20 mg/day [≤ 75 years old] or 10 mg/day [>75 years old] will be taken orally on Days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on Days 1, 2, 8, 9 of 21 days for cycles 9 and onward until disease progression.
16155876|NCT01734915|Device|Circulating tumor cell chip|three tubes (6 teaspoons) of peripheral blood are drawn and are analyzed using the CTC chip
16155877|NCT01734902|Drug|Hyoscine butylbromide|sugar coated tablets for oral administration
16155878|NCT01734902|Drug|Hyoscine butylbromide|drops for oral administration
16155879|NCT01734889|Drug|Nitisinone|Oral suspension
16155880|NCT01734876|Behavioral|Tactile Touch|Tactile Touch was performed for 10 times during a 8 week period.The method consists of a superficial whole body tactile touch, following a structural scheme. Participants in a horizontal position, in a tempered room. Aroma of lavendar and quiet music in the background.
16155881|NCT01734876|Behavioral|Rest To Music|Participants in horizontal position. Rest in a temperated room, aromas and quiet music in the background. Time: About 30 minutes.
16155882|NCT01734863|Radiation|External Beam Radiotherapy|
16155883|NCT01734850|Drug|Busulfan|Intravenous busulfan
16155884|NCT01734850|Biological|Cal-1 modified HSPC|Hematopoietic progenitor/stem cells (HSPC) modified with LVsh5/C46 (Cal-1)
16155885|NCT01734850|Biological|Cal-1 modified CD4+ T lymphocytes|CD4+ T lymphocytes modified with LVsh5/C46 (Cal-1)
16155886|NCT01734837|Device|DS-Ligature Clip|
16155887|NCT01734824|Drug|Denosumab|sc RANKL-inhibitor
16155888|NCT01734824|Drug|Teriparatide|daily subcutaneous injection of teriparatide
16155889|NCT01734824|Drug|Placebo Denosumab|one subcutaneous injection denosumab placebo
16155890|NCT01734824|Drug|Placebo Teriparatide|daily subcutaneous placebo injection
16155891|NCT01734811|Biological|Biological vaccine|daily spray (2 puff of 100 µL) for six months
16155892|NCT01734798|Radiation|Radiation|
16155893|NCT01734798|Drug|gemcitabine and cisplatin|
16155894|NCT01734798|Other|Radiotherapy and Drug|
16155895|NCT01734785|Drug|Linagliptin|tablet
16155896|NCT01734785|Drug|Empagliflozin + Linagliptin|Fixed dose combination.
16155897|NCT01734785|Drug|Empagliflozin + Linagliptin|Fixed dose combination
16155898|NCT01734785|Drug|Empagliflozin + Linagliptin|Fixed dose combination
16155899|NCT01734785|Drug|Empaglifozin placebo + Linagliptin placebo|Matching Empaglifozin + Linagliptin low dose
16155900|NCT01734785|Drug|Empagliflozin + Linagliptin|Fixed dose combination.
16155901|NCT01734772|Drug|dabigatran etexilate|multiple doses of dabigatran
16155902|NCT01734772|Drug|dabigatran etexilate|medium dose dabigatran
16155903|NCT01734772|Drug|ticagrelor|loading dose of ticagrelor
16155904|NCT01734772|Drug|ticagrelor|multiple doses of ticagrelor
16155905|NCT01734772|Drug|ticagrelor|loading dose of ticagrelor
16155906|NCT01734772|Drug|dabigatran etexilate|single dose of dabigatran
16155907|NCT01734759|Drug|Taste Test|"Before the taste test each participant will fill out an informed consent form and an enrollment survey. Each participant will receive 0.5 mL of each study medication in the taste test. During the taste test each medication in a class will be labeled with a color name so as to prevent any bias from preconceived taste perception. They will record their perception of the medications taste on a visual analog scale (VAS). An anaphlyaxis kit will be on hand in case of emergencies. Between samples participants will cleanse their palate with a saltine cracker and 30 mL of water. 5 different classes of medications will be tested.
~Medications to be sampled and the corresponding dose of the test dose are:
~Cephalosporins: cefdinir 12.5 mg, cefixime 10 mg
~Penicillins: penicillin VK 12.5 mg, amoxicillin 12.5 mg
~Analgesic/antipyretics: acetaminophen 16 mg, ibuprofen 10 mg
~Steroids: prednisolone 1.5 mg, prednisone 0.5 mg
~H2 receptor blockers: famotidine 4 mg, ranitidine 7.5 mg"
16155908|NCT01734746|Procedure|Tracerinjection|The intervention concerns the tracerinjection for detection of the sentinel node.
16155909|NCT01734733|Other|NTCELL|
16155910|NCT01734707|Dietary Supplement|Allicor|
16155911|NCT01734707|Drug|Placebo|Sugar pill manufactured to mimic Allicor 150 mg tablet
16155912|NCT01734694|Drug|Vancomycin|"Dose optimized vancomycin. Target trough: 15 - 20 mg/L for Health Care Associated Pneumonia, Osteomyelitis, Septic Arthritis, Endocarditis and Bacteremia;
~Target trough: 10 - 20 mg/L for Acute Bacterial Skin and Skin Structure Infections;"
16155913|NCT01734694|Drug|Ceftaroline|"Dose based on package insert labeling
~CrCL > 50 mL/min: 600 mg IV q12h
~CrCL 31-50 mL/min: 400 mg q12h
~CrCL 15-30 mL/min: 300 mg q12h
~CrCL < 15mL/min: 200 mg q12h;"
16155914|NCT01734694|Drug|Daptomycin|"Dose based on renal function and literature dosing recommendations
~CrCL ≥ 30 mL/min: 6 - 10 mg/kg IV q24h
~CrCL < 30 mL/min: 6 - 10 mg/kg IV q48h"
16155915|NCT01734694|Drug|Linezolid|600 mg IV/PO q12h
16155916|NCT01734681|Drug|G-202|
16155917|NCT01734668|Device|In Vitro Diagnostic device to aid in diagnosis|
16155918|NCT01734616|Behavioral|Old Exercise|
16155919|NCT01734616|Dietary Supplement|Old Acute Cocoa|
16155920|NCT01734616|Dietary Supplement|Old 7 Day Cocoa|
16155921|NCT01734603|Procedure|experimental rehabilitation program|"Duration training = 40 min : 5 cycles of 6 min each Week 1 speed of the walking exercise fixed at 70% of the max walking test's speed done on the initial walking test speed of the walking recovery fixed at 40% Walking slope : 0% Increase of the speed = 0.1 km/h after each training without pain.
~Week 2 Walking speed = average of the walking speeds done on week 1 Walking slope = 1% Recovery slope = 0% Increase of the slope = 0.5% after each training without pain.
~Week 3 Walking speed = 70% of the maximal walking test's speed Recovery speed = 40 % of the maximal walking test's speed Slope = average of the slopes done on week 2 Increase of the speed = 0.1 km/h .
~Week 4 Speeds = average of the walking speeds done on week 3 Walking slope = 1% Recovery slope = 0% Increase of the slope is 0.5% ."
16155956|NCT01734395|Drug|Galantamine|This is an observational study. Galantamine 8 mg/day will be administered for the first 4 weeks and later on the dose will increased up to 24 mg (if tolerable). Galantamine dose will be adjusted according to the investigator's discretion.
16155957|NCT01734382|Drug|Tocilizumab|Participants will receive tocilizumab IV infusions of 12 mg/kg (for participants < 30 kg) or 8 mg/kg (for participants >/=30 kg) Q2W/Q3W/Q4W.
16155958|NCT01734356|Other|Skin biopsies|
16155962|NCT01734330|Drug|Nicotine replacement|
16155922|NCT01734603|Procedure|conventional rehabilitation program|"Duration of the training 40 minutes (time excluding rest and warm up)
~Initial intensity = 3.2 km per hour and slope at 0% Walking until pain 3/5, then stop until pain completely subsides.Resume of walking as soon as possible.
~Increase :
~Week 1: if the walking is possible during 8 minutes, increase of the slope of 0.5% in each training until 10% Week 2 :if the walking is possible during 8 minutes, increase of the speed 0.2 mile per hour until 3 mph Week 3 :if the walking is possible during 8 minutes, increase of the slope 2% at each training until 15% Week 4 : if the walking is possible during 8 minutes, increase the speed 0.2mph at each training as long as it is possible."
16155923|NCT01734590|Dietary Supplement|Carbohydrate based food mix 1|Carbohydrate based food
16155924|NCT01734590|Dietary Supplement|Carbohydrate based food mix 2|Carbohydrate based food
16155925|NCT01734590|Dietary Supplement|Control carbohydrate based food|Carbohydrate based food
16155926|NCT01734577|Procedure|Dry needling|Sterile monofilament needles
16155927|NCT01734577|Procedure|Sham needling|Applicator tubes from the sterile monofilament needles
16155928|NCT01734564|Biological|Hiltonol and autologous dendritic cells|Hiltonol and autologous dendritic cells
16155929|NCT01734564|Radiation|Hiltonol, dendritic cells and radiation|Hiltonol, autologous dendritic cells and radiation therapy. Radiation therapy will pursue an abscopal effect.
16155930|NCT01734551|Drug|Morphine|"Start at 0.4mg/kg/day (divided every 3-4 hours, given with feeds. Dose may be increased 25% of initial dose until symptoms are stable, up to 1 mg/kg/day.
~Once stable for 72 hrs, weaning may begin (decrease 10% of max dose, every other day). When total dose is <0.1mg/kg/day, may discontinue."
16155931|NCT01734551|Drug|Clonidine|Initial dose is 5 mcg/kg/day (divided every 3-4 hrs, given with feeds). Will increase 25% of initial dose every 12-24 hrs until stable, up to 12 mcg/kg/day. Dose is unchanged for 72 hours once stable, then may decrease by 10% every other day. If re-escalation is required, the previous dose may be used with 72 hours for stabilizing.
16155932|NCT01734538|Dietary Supplement|Omega-3 Complete|
16155933|NCT01734538|Dietary Supplement|Placebo capsule|
16155934|NCT01734525|Drug|Anidulafungin|Anidulafungin at a dose of 200 mg in the first day and 100 mg daily afterwards
16155935|NCT01734512|Drug|Everolimus|Everolimus tablet will be taken daily by mouth with water. All patients will be given a dose of 5 mg/m2/dose daily.
16155936|NCT01734499|Behavioral|Coping Class|"A 4-hour structured program which will be offered once a month as the Coping Class by a certified facilitator of The Change Cycle. The coping class uses standardized materials and skills training. Standardized materials for the intervention arm will include Change Moves Me Participant's Guide/Journal, Locator Assessment Profile, The Change Cycle Color Model, and class evaluation. The structure of the class includes a profile of each stage to gain perspective and understanding, teaching personal change skills for each stage and a primary focus for movement to the next stage. The overall design follows an act as if philosophy, guiding participants through each stage of The Change Cycle, irrespective of which stage they are actually in."
16155937|NCT01734499|Behavioral|Standard of Care|Standard of Care. Three components of this: (1)Surveillance Program: all patients diagnosed with breast cancer are seen every six months for the first two years and yearly thereafter to rule out disease recurrence by history and physical exam at each visit in addition to the annual mammogram. (2)Local support groups centered at community cancer centers. These are generally attended by 12-16 women monthly; all breast cancer patients receive the information about these groups. Associated with these programs, some classes are offered sporadically in nutrition, and exercise. (3)Comprehensive Postoperative Rehabilitation which offers physical and occupational rehabilitation to all women, thus provides prevention and treatment of lymphedema and monitored shoulder range of motion.
16155938|NCT01734499|Behavioral|FACT-B Quality of Life|The FACT-B Quality of Life is a 44-item instrument that was developed by combining nine breast cancer-specific QL items with the FACT general QL instrument. The FACT-B consists of the following subscales: physical wellbeing (PWB), functional wellbeing (FWB), emotional wellbeing (EWB), social/family wellbeing (SWB), and breast cancer specific concerns (BCS).
16155939|NCT01734486|Drug|somatropin|0.9 UI/kg/week. Subcutaneous injection for 3 years
16155940|NCT01734486|Drug|somatropin|1.8 UI/kg/week. Subcutaneous injection for 3 years
16155941|NCT01734473|Dietary Supplement|Hydrolyzed casein protein|Amount provided is based on the fat-free mass of subject
16155942|NCT01734473|Dietary Supplement|Hydrolyzed casein protein + carbohydrates|Amount provided is based on the fat-free mass of subject
16155943|NCT01734473|Dietary Supplement|Hydrolyzed casein protein + leucine|Amount provided is based on the fat-free mass of subject. Leucine (40% of essential amino acid content)
16155944|NCT01734473|Dietary Supplement|Hydrolyzed casein protein + carbohydrates + leucine|Amount provided is based on the fat-free mass of subject. Leucine (40% of essential amino acid content)
16155945|NCT01734473|Dietary Supplement|4 levels of hydrolyzed casein protein + carbohydrates|Amount provided is based on the fat-free mass of subject. The 4 levels are: 0, 0.02, 0.05, 0.15 g casein protein/kg fat free mass/hr. The ratio between protein and carbohydrates is fixed.
16155946|NCT01734447|Drug|somatropin|1.2 IU/kg/week, one injection per day, in six days out of seven days, for 12 months
16155947|NCT01734447|Drug|somatropin|1.2 IU/kg/week, one injection per day, in six days out of seven days, for 6 months out of 12 months (i.e. alternating periods of 6 months of treatment and non-treatment, respectively)
16155948|NCT01734447|Drug|somatropin|2.4 IU/kg/week, one injection per day, in six days out of seven days, for 6 months out of 12 months (i.e. alternating periods of 6 months of treatment and non-treatment, respectively)
16155949|NCT01734421|Other|Control group|6-month implementation of recommendations of a Clinical Practice Guideline smoking cessation
16155950|NCT01734421|Device|Cell phone Aplication for Smarth Phone|
16155951|NCT01734408|Biological|alum-adjuvant 160U /0.5ml|inactivated vaccine (vero cell) alum-adjuvant 160U /0.5ml EV71 vaccine
16155952|NCT01734408|Biological|alum-adjuvant 320U /0.5ml|inactivated vaccine (vero cell) alum-adjuvant 320U /0.5ml EV71 vaccine
16155953|NCT01734408|Biological|alum-adjuvant 640U /0.5ml|inactivated vaccine (vero cell) alum-adjuvant 640U /0.5ml EV71 vaccine
16155954|NCT01734408|Biological|adjuvant-free 640U /0.5ml|inactivated vaccine (vero cell) adjuvant-free 640U /0.5ml EV71 vaccine
16155955|NCT01734408|Biological|0/0.5ml placebo|0/0.5ml placebo
16155963|NCT01734317|Device|Mepilex Transfer Ag|A soft silicone wound contact layer.
16155964|NCT01734304|Biological|DC vaccination for postremission therapy in AML|Vaccination with TLR7/8-matured DCs electroporated with mRNA encoding WT1, PRAME, and CMVpp65
16155965|NCT01734291|Behavioral|Family psychoeducation|Family psychoeducational therapy every two weeks for six weeks in addition to treatment as usual administered by physicians
16155966|NCT01734278|Other|No intervention|This is a non-interventional study.
16155967|NCT01734265|Drug|Depigoid 50% Grasses/50% Olea europaea (2000DPP/ml)|
16155968|NCT01734265|Drug|Depigoid 50% Grasses/50% Parietaria judaica (2000DPP/ml)|
16155969|NCT01734252|Drug|Argatroban|Start: Argatroban dose is 0.05 µg/kg/min (patients with hepatic impairment, after cardiac surgery) until maximum: 10 µg/kg/min
16155970|NCT01734239|Biological|Pneumovax™ 23|Vaccine contains 25 µg of each of the 23 pneumococcal polysaccharides serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19F, 19A, 20, 22F, 23F, and 33F
16155971|NCT01734226|Dietary Supplement|Prunus Mume Extract|Prunus Mume Extract (3.94g/day)
16155972|NCT01734226|Dietary Supplement|Placebo|Placebo (3.94g/day)
16155973|NCT01734213|Dietary Supplement|Eriobotyra Japonica Lindley Extract|Eriobotyra Japonica Lindley Extract (1.5g/day)
16155974|NCT01734213|Dietary Supplement|Placebo|Placebo (1.5g/day)
16155975|NCT01734200|Dietary Supplement|Eriobotyra Japonica Lindley Extract|Eriobotyra Japonica Lindley Extract (1.5g/day)
16155976|NCT01734200|Dietary Supplement|Placebo|Placebo (1.5g/day)
16155977|NCT01734187|Dietary Supplement|Fermented Cinnamon Vine Powder|Fermented Cinnamon Vine Powder (30g/day)
16155978|NCT01734187|Dietary Supplement|Placebo|Placebo (30g/day)
16155979|NCT01734174|Procedure|transesophageal echocardiography (TEE)|Echocardiography is an ultrasound-based imaging technique which can be performed through the esophagus (which lies behind the heart) and is performed routinely as a monitoring and diagnostic tool at different times in the course of one cardiac surgery.
16155980|NCT01734174|Procedure|thermodilution|A catheter is positioned in the pulmonary artery and the heart function is assessed via thermodilution which involves measuring the temperature of blood when a known volume of fluid is injected through the catheter to determine how quickly blood is carried from one part of the catheter to the other.
16155981|NCT01734174|Procedure|transthoracic echocardiography (TTE)|Echocardiography is an ultrasound-based imaging technique which can be performed through the chest wall and is performed routinely as a monitoring and diagnostic tool at different times in the course of one cardiac surgery.
16155982|NCT01734161|Drug|Dexamethasone|8mg IV dexamethesone given
16155983|NCT01734161|Drug|Placebo|Subjects randomized to placebo receive 50cc normal saline
16155984|NCT01734148|Behavioral|Relax To Sleep Program|The educational portion of the program will consist of a standardized educational booklet and a discussion with the PI and provides a brief overview will be given on normal sleep and sleep patterns, children's sleep needs, and the signs and consequences of sleep disturbance. Second, the educational booklet provides sleep hygiene info. The second component consists of of good sleep habits such as having a regular sleep-wake schedule, avoiding caffeine intake prior to sleep, avoiding stimulating activities near nighttime sleep, avoidance of naps during the day, ensuring that the child is exposed to natural light during the day, providing the child with opportunities to socialize during the day. Finally, the program consists of a relaxation breathing technique for the child.
16155985|NCT01734135|Other|Clinical Reminder|A note is sent to the primary care provider using the electronic medical record indicating the high BNP result and potential benefit of measurement of the left ventricular ejection fraction. A draft order is placed for an echocardiogram for the provider to accept or delete.
16155986|NCT01734122|Other|Questionnaires / Observational Assessments|Includes QUEST, PDQ-39, FTM, and Neuropsych evaluation
16155987|NCT01734109|Device|Quantum Negative Pressure Wound Therapy Device|To compare the additional benefit of Quantum Negative pressure wound therapy device with and without simultaneous irrigation.
16155988|NCT01734096|Other|Lower body negative pressure (LBNP)|Lower limbs are put in in LBNP device for one hour (-30 mbar)
16155989|NCT01734096|Drug|Candesartan cilexetil|candesartan cilexetil 16 mg once a day for 7 days cross over with placebo in control group, obesisty group and white coat hypertension group
16155990|NCT01734083|Device|Whole body vibration exercise|The whole body vibration will be delivered by a platform that can generate vibration signals (Powerplate). The total duration of vibration exposure per session will range from 4 to 6 minutes. The vibration bouts (30-45 seconds per bout) will be interspersed with a 1 to 2 minutes of rest period. While standing on the vibration platform, subjects will be instructed to repeat two exercises: (1) static semi-squats, and (2) dynamic semi-squats.
16155991|NCT01734083|Behavioral|Conventional exercise|The conventional exercise training will involve a combination of upper limb and lower limb stretching and strengthening exercises, balance training, and gait re-education.
16155992|NCT01734070|Other|Cherry consumption|Volunteers will eat 280 grams/day of pitted Bing cherries by replacing an equivalent amount of carbohydrate calories.
16155993|NCT01734057|Drug|recombinant human thrombopoietin (rhTPO); rituximab|patients in recombination treatment group take Rituximab( intravenously ,100 mg weekly for 4 consecutive weeks); in combination with rhTPO( subcutaneously , 300U/kg for 14 consecutive days,followed by flexible treating dosage so as to keep the platelet count above 50×10^9/L until the 28th day)
16155994|NCT01734057|Drug|Dexamethasone|Patients in single treatment group take dexamethasone intravenously at 40 mg daily for 4 consecutive days.
16155995|NCT01734044|Drug|recombinant human thrombopoietin (rhTPO); dexamethasone|Patients in recombination treatment group take rhTPO( subcutaneously , 300U/kg for 14 consecutive days, followed by flexible treating dosage so as to keep the platelet count above 50×10^9/L until the 28th day), in combination with dexamethasone(intravenously , 40mg/d for 4 consecutive days)
16155996|NCT01734044|Drug|Dexamethasone|Patients in single treatment group take dexamethasone intravenously at 40 mg daily for 4 consecutive days.
16155997|NCT01734005|Dietary Supplement|Red Ginseng|Red Ginseng (1.4g/day)
16155998|NCT01734005|Dietary Supplement|Placebo|Placebo (1.4g/day)
16155999|NCT01733992|Drug|R348 Ophthalmic Solution, 0.2%|R348 Ophthalmic Solution, 0.2% single and multiple ascending dose
16156000|NCT01733992|Drug|R348 Ophthalmic Solution, 0.5%|R348 Ophthalmic Solution, 0.5%, single and multiple ascending dose
16156001|NCT01733992|Drug|R348 Ophthalmic Solution, 1.0%|R348 Ophthalmic Solution, 1.0%, single and multiple ascending dose
16156002|NCT01733992|Drug|Placebo|Placebo, single and multiple ascending dose
16156003|NCT01733979|Dietary Supplement|Heme-Iron Polypeptide|Heme-Iron Polypeptide (1g/day)
16156004|NCT01733979|Dietary Supplement|Placebo|Placebo (1g/day)
16156005|NCT01733979|Dietary Supplement|Heme-Iron|Heme-Iron (1g/day)
16156006|NCT01733979|Dietary Supplement|Organic Iron|Organic Iron (1g/day)
16156007|NCT01733966|Drug|Secnidazole, ciprofloxacine|"2g of microgranules of secnidazole. a single dose per day during 3 days.
~1g of Ciprofloxacin (2 tablets of 500mg per day during 3 days)"
16156008|NCT01733966|Drug|Amoxicillin-Clavulanic Acid|3g of Amoxicillin-Clavulanic acid (3 powder packet of 1g per day during 10 days)
16156009|NCT01733953|Drug|Atorvastatin|6-Months of Atorvastatin (Lipitor); 40mg, oral, once daily.
16156010|NCT01733953|Drug|Sugar Pill (Placebo)|6-Months of placebo (sugar) pill; oral, once daily
16156011|NCT01733940|Device|Application of a dressing with clorhexidine gluconate in intravascular catheters.|
16156012|NCT01733940|Device|Application of a dressing without clorhexidine gluconate|
16156013|NCT01733927|Device|Rapid testing for HIV|The research team members were trained and certified in administering the OQA testing through the AIDS International Consortium in Philadelphia (WHCI), USA. During the recruitment process, participants were informed about the nature of the test, the length of time for results, and what procedures would be involved in self-administering the OQA test. After providing informed consent, including the release of information for research use, participants demonstrated their ability to properly take an OQA sample using a popsicle stick as a proxy for the testing device.
16156014|NCT01733914|Procedure|Acupuncture|Acupuncture in the following acupoints on the contralateral side of pain site: Jiantong, Zhongzhu, Houxi, and Quchi. The patient will receive 5 treatments (each lasts 30 min) per week for four weeks.
16156015|NCT01733914|Other|Control|Patients in the waiting list group received conventional orthopaedic therapy including physical exercise, heat or cold therapy. 50 mg diclofenac daily could be taken when the patient suffered from the pain. Injections or cortisone applications of any kind were not allowed.
16156016|NCT01733901|Procedure|RSD|Contrast renal angiography was performed to localize and assess the renal arteries for accessibility and appropriateness for RSD. Once the anatomy was deemed acceptable, the internally irrigated radiofrequency ablation catheter(Celcius Thermocool,Biosense Webster, Diamond Bar, California) was introduced into each renal artery. then was maneuvered within the renal artery to allow energy delivery in a circumferential, longitudinally staggered manner to minimize the chance of renal artery stenosis. About six to nine ablations at 10 W for 1 min each were performed in both renal arteries. During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm.
16156017|NCT01733901|Procedure|PCI|Percutaneous coronary intervention (PCI) is a non-surgical procedure used to treat the stenotic coronary arteries of the heart found in CHD. During PCI, a cardiologist feeds a deflated balloon or other device on a catheter from the inguinal femoral artery or radial artery up through blood vessels until they reach the site of blockage in the heart. X-ray imaging is used to guide the catheter threading. At the blockage, the balloon is inflated to open the artery, allowing blood to flow. A stent is often placed at the site of blockage to permanently open the artery.
16156018|NCT01733888|Device|Office Bleaching with 35 % Hydrogen Peroxide|In this group before starting the procedure the teeth intended to be treated will be cleaned with pumice and after that cheek retractors will be placed and exposed lip surface will be covered with petroleum gel. Thereafter, teeth will be dried and gingival Barrier will be applied to both arches, slightly overlapping enamel and interproximal spaces. Light curing of the gingival barrier will be done in a fanning motion for 10-20 seconds . Once the gingival barrier will be cured then homogeneous mixing of the powder and liquid will be done in powder pot, followed by application of thick layer of gel to all teeth undergoing treatment. The gel will be then left in place for 8 minutes and after that the gel will be removed using a surgical aspirator tip.
16156019|NCT01733888|Device|Icon Infiltration|In this group after taking pre-operative photographs the fluorosed tooth will be isolated using rubber dam and the Resin infiltrant (Icon, DMG, Hamburg, Germany) will be applied as per manufactures' instructions. For this purpose, after rubber dam application tooth surface will be dried using cotton rolls and air syringe. Icon Etchant will be applied and left for 2 minutes followed by rinsing and air drying for 30 sec. After complete etching, Drying agent (99% ethanol), as supplied in the Icon kit. Resin infiltrant will then be applied and allowed to seep in for 3 minutes followed by light curing for 40 seconds followed by cleaning of the surface with pumice and rubber polishing cup and rinsing with water for 30 sec. After application, patient will be instructed neither to eat nor brush their teeth for 45 minutes.
16156020|NCT01733888|Device|Icon Infiltration twice|"In this group application of the resin infiltration shall be done similar to the procedure as explained for intervention Icon infiltration, but the resin infiltrant shall be applied twice."
16156021|NCT01733888|Device|Bleaching+Icon Infiltration|"In this group vital bleaching will be done using 35 % Hydrogen Peroxide (Pola Office, SDI, Australia), as explained in intervention bleaching; followed by wash over period of 20 days. After 20 days the patient will be recalled and on the day of appointment initially a new preoperative photograph shall be taken, then the fluorosed tooth will be isolated using rubber dam and the Resin infiltrant (Icon, DMG, Hamburg, Germany) will be applied as per manufactures' instructions, similar to intervention Icon Infiltration. For this group a postoperative photograph shall be taken after the application of RI and then the circle of post-operative recall shall be counted from here, that is, 1week, 1 month and 6 months respectively."
16156022|NCT01733875|Drug|CC-220 0.03 mg|A single dose of CC-220 0.03 mg will be administered orally once a day.
16156023|NCT01733875|Drug|CC-220 0.1 mg|A single dose of CC-220 0.1 mg will be administered orally once a day.
16156024|NCT01733875|Drug|CC-220 0.3 mg|A single dose of CC-220 0.3 mg will be administered orally once a day.
16156025|NCT01733875|Drug|CC-220 1 mg|A single dose of CC-220 1 mg will be administered orally once a day.
16156026|NCT01733875|Drug|CC-220 2 mg|A single dose of CC-220 2 mg will be administered orally once a day.
16156027|NCT01733875|Drug|Placebo|A single dose of placebo will be administered orally once a day.
16156028|NCT01733875|Drug|CC-220|CC-220 4 mg will be administered orally once a day
16156029|NCT01733875|Drug|CC-220|CC-220 6 mg will be administered orally once a day
16156030|NCT01733875|Drug|CC-220|CC-220 1 mg will be administered orally once a day in each of 2 study periods - once with food and once without food
16156031|NCT01733862|Other|Data collection|"Data sheet. Data will be collected and is planned to be analysed at the following time points:
~Pre-vaccination period: Nov 2007 to Oct 2011, transition period: Nov 2011 to Oct 2012 and post vaccination period: Nov 2012 to Oct 2016."
16156032|NCT01733849|Other|Stool sample|Samples will be tested to determine the presence or absence of rotavirus.
16156033|NCT01733849|Other|Data collection|Log books
16156034|NCT01733836|Drug|Metformin|
16156035|NCT01733836|Drug|placebo|
16156036|NCT01733823|Radiation|76 Gy/ 56 fx/ 10/W with cisplatin 40 mg/m2/W and nimorazole|
16156037|NCT01733810|Other|Cessation of Acid Suppressing Medications|Acid-suppressing medications are stopped for all participants the day after baseline assessment. Subsequent evaluations performed while participant is not on acid-suppressing medications.
16156038|NCT01733797|Device|Wooden spatula|Lollipop sticks placed between incisors
16156039|NCT01733797|Device|Therabite|Hand held device placed in mouth that exercises the jaw
16156040|NCT01733784|Other|Induced central apneas|
16156041|NCT01733771|Other|CAM treatments|CAM treatments last 10-30 minutes
16156042|NCT01733758|Drug|Albiglutide 30 mg weekly|Albiglutide will be available as a pen injector that delivers 30mg of albiglutide
16156043|NCT01733758|Drug|Albiglutide 50 mg weekly|Albiglutide will be available as a pen injector that delivers 50mg of albiglutide
16156044|NCT01733758|Drug|Placebo|Albiglutide matching placebo will be available as a pen injector
16156045|NCT01733758|Drug|Liraglutide 0.9 mg daily|Liraglutide will be available as prefilled multidose pens that can deliver 0.9 mg dose
16156046|NCT01733745|Other|SYSTANE® Lid Wipes|Pre-moistened eyelid cleansing wipes for topical ocular external scrubbing of eyelids and eyelashes
16156047|NCT01733745|Other|SYSTANE® BALANCE|Lubricant Eye Drops
16156048|NCT01733745|Dietary Supplement|SYSTANE® Vitamins|
16156049|NCT01733745|Other|Microfiber towels (as warm compresses, with or without saline eye drops)|
16156050|NCT01733732|Other|SYSTANE® BALANCE Lubricant Eye Drops|
16156051|NCT01733732|Other|SYSTANE® Gel|
16156052|NCT01733719|Procedure|ER plus RFA|
16156053|NCT01733719|Procedure|ER plus APC|2 litres/minute, 70 watts
16156054|NCT01733706|Device|No nicotine electronic cigarette|"The e-cigarette T-FUMOTM is a no nicotine electronic cigarette specifically designed to inactivate the early effects of the cessation of cigarette smoking, such as the craving caused by psychological reasons. It's formed by a filter which contains distilled water and food flavorings, an atomizer and a battery. On the opposite end to the filter there is a diode that lights up during aspiration. During the suction is generated hot air which, in contact with the liquid of the filter, generates steam which simulates the smoke of a traditional cigarette. The smoker has the sensation of smoking, but he does not suck the carcinogenic substances in traditional cigarettes and he does not assimilate nicotine."
16156055|NCT01733706|Other|Standard counseling|standard counseling
16156056|NCT01733693|Drug|Buprenorphine|Study participants will be randomly assigned 1:1 to buprenorphine (experimental/intervention) or methadone (active comparator). We will stratify by HIV status to ensure an equal number of HIV-infected participants in each group.
16156057|NCT01733693|Drug|Methadone|Study participants will be randomly assigned 1:1 to buprenorphine (experimental/intervention) or methadone (active comparator). We will stratify by HIV status to ensure an equal number of HIV-infected participants in each group.
16156058|NCT01733680|Drug|amiloride|Subjects will take either amiloride hydrochloride or placebo for 8 weeks.
16156059|NCT01733680|Behavioral|Behavioral|Each week of the study, subjects will complete the AISRS, BRIEF-A, and CGI to measure symptom improvement
16156060|NCT01733667|Device|MediENT|MediENT will be assigned to either the right or left side and positioned between the turbinate and nasal wall of the side assigned. MeroPack will be place in between the turbinate and nasal wall of the side not assigned to MediENT
16156061|NCT01733667|Device|MeroPack|MediENT will be assigned to either the right or left side and positioned between the turbinate and nasal wall of the side assigned. MeroPack will be place in between the turbinate and nasal wall of the side not assigned to MediENT
16156062|NCT01733654|Biological|RO4995819|The investigation of RO4995819 as adjunctive therapy in MDD patients is supported by preclinical and clinical evidence implicating dysfunction of glutamatergic pathways in the pathophysiology of depression and cognitive disorders, and accumulated evidence of the antidepressant and procognitive effects of mGlu2/3 antagonism.
16156063|NCT01733602|Device|transcranial direct current stimulation|
16156064|NCT01733589|Drug|Recombinant human endostatin|Recombinant human endostatin(7.5mg/m2/24h) Continued Pumping Into Vein through 5 days at week 1, 3, 5, and 7,combined with concurrent chemo-radiotherapy.
16156065|NCT01733589|Drug|Etoposide (50mg/m2) IV (in the vein) on day 1 to day 5 of a 28-day cycle for 2 cycles|
16156066|NCT01733589|Drug|cisplatinum (50mg/m2) IV (in the vein) on day 1 and day 8 of a 28-day cycle for 2 cycles|
16156067|NCT01733589|Other|laboratory biomarker analysis|
16156068|NCT01733589|Other|CT perfusion imaging|
16156069|NCT01733576|Device|HD-tDCS|
16156070|NCT01733563|Procedure|Soft drink consumption|
16156071|NCT01733550|Device|Home iCare (study nurse)|the intraocular pressure is measured by iCare performed by the study nurse
16156072|NCT01733550|Device|goldmann applanation tonometry|the intraocular pressure is measured by goldmann applanation tonometry
16156073|NCT01733550|Device|home iCare (by patient)|the intraocular pressure is measured by the iCare performed by the patient him self
16156074|NCT01733537|Other|Free reflective, fluorescent vest|Motorcycle taxi drivers in the intervention arm will receive a free reflective, fluorescent vest
16156075|NCT01733537|Behavioral|Education|Both arms will receive brief, basic education about recommended measures to increase their visibility
16156076|NCT01733524|Behavioral|Pet Fish|Participants will receive a betta fish and the supplies to care for the fish for a one year time period.
16156077|NCT01733524|Behavioral|Picture of a fish|Participants will receive a picture of a betta fish.
16156078|NCT01733485|Drug|Aspirin|500 mg/8 h for 5 days
16156079|NCT01733485|Drug|Indomethacin|25 mg/8 h for 5 days
16156251|NCT01732198|Biological|ActHIB|
16156080|NCT01733472|Drug|GA-arm, remifentanil|"Remifentanil and propofol will be delivered intravenously via TCI pumps according to the Marsh and Minto algorithm"
16156081|NCT01733472|Drug|RA-arm|Intrathecal (i.e. spinal) anesthesia with isobaric bupivacaine 15 mg administered intrathecally at L4-L5.
16156082|NCT01733459|Drug|DLBS3233|1 DLBS3233 capsule 100 mg once daily for 6 months
16156083|NCT01733459|Drug|Metformin XR|1 Metformin XR caplet 750 mg twice daily for 6 months
16156084|NCT01733459|Drug|Placebo caplet of Metformin XR|1 placebo caplet of Metformin XR twice daily for 6 months
16156085|NCT01733459|Drug|Placebo capsule of DLBS3233|1 placebo capsule of DLBS3233 once daily for 6 months
16156086|NCT01733446|Other|Continuation of High Frequency Jet Ventilation (HFJV)|In Group B, after cessation of anesthetic infusions, High Frequency Jet Ventilation (HFJV) will continue through the endotracheal tube. Patient will be extubated when awake. Respiratory Inductance Plethysmography (RIP) and Transcutaneous carbon dioxide (PtcCO2) measurements will continue for the duration of emergence.
16156087|NCT01733433|Procedure|Taping the ankle|Subjects will be taped in at the ankle for performing several exercises.
16156088|NCT01733420|Drug|Biodentine pulpotomy|
16156089|NCT01733420|Drug|White MTA pulpotomy|
16156090|NCT01733420|Drug|Tempophore pulpotomy|
16156091|NCT01733407|Drug|L-serine|400mg/kg/d L-serine or placebo divided TID for year 1, then crossover of placebo arm so that all patients on 400mg/kg/d L-serine divided TID for year 2.
16156092|NCT01733407|Drug|placebo|400mg/kg/d divided TID for year 1 only.
16156093|NCT01733394|Drug|"Lamotrigine Generic A Lamotrigine Generic B Lamotrigine Brand"|
16156094|NCT01733394|Drug|lamotrigine|
16156095|NCT01733355|Radiation|[F18] T807|Dose for normal volunteer undergoing dosimetry evaluation will not exceed 20 mCi, dose for high probability of Alzheimer's and low probability Alzheimer's undergoing brain imaging only will not exceed 10 mCi
16156096|NCT01733342|Device|Celsite chemoport implantation|Celsite chemoport implantation was done under local anesthesia, at anterior chest wall, under ultrasound guidance
16156097|NCT01733342|Procedure|local anesthesia|chemoport implantation will be done under local anesthesia using lidocaine.
16156098|NCT01733342|Device|Humanport chemoport implantation|Humanport chemoport implantation was done under local anesthesia, at anterior chest wall, under ultrasound guidance
16156099|NCT01733329|Drug|Misoprostol|At cord clamping 2 tablets (400 mcg) were placed in the patient´s buccal space by anesthesiologist.
16156100|NCT01733329|Drug|Folic Acid|At cord clamping 2 tablets (10 mg) were placed in the patient´s buccal space by anesthesiologist.
16156101|NCT01733316|Drug|RP103|
16156102|NCT01733316|Drug|Cystagon®|
16156103|NCT01733303|Behavioral|personalized core muscle training program|Participants are allocated to the exercise group will commence the personalized core training exercise with EMG biofeedback based on their testing results in muscle quality. The program will run for 3 months with patients attending for one hour three times a week. The age-matched control group will maintain their usual daily life activities without any specific instruction. The exercise training will be run by an experienced physiotherapist, who will encourage patients individually to progress at their own pace.
16156104|NCT01733290|Drug|Botulinum toxin A|A total of 100 units of BoNT-A will be injected deeply into the external sphincter at the 3, 6, 9 and 12 o'clock positions in approximate equal aliquot.
16156105|NCT01733290|Drug|Normal saline instillation|Normal saline instillation
16156106|NCT01733277|Other|Magnetic Resonance Imaging (MRI)|All participants from both arms will be subjected to MRI
16156107|NCT01733238|Drug|PNT2258|
16156108|NCT01733212|Drug|Ginger|Ginger is an herb. The rhizome (underground stem) is used as a spice and also as a medicine. It can be used fresh, dried and powdered, or as a juice or oil. Two capsules (1g each) of dry powdered ginger are given, one capsule a half-hour before induction of anesthesia and the second 2h after surgery.
16156109|NCT01733212|Drug|Placebo Oral Tablet|Two capsules (1g each) of placebo, one capsule a half-hour before induction of anesthesia and the second 2h after surgery.
16156110|NCT01733199|Other|questionnaires|Summons of patients and filling questionnaire.
16156111|NCT01733186|Biological|CARTISTEM®|
16156112|NCT01733173|Procedure|MRI with DTI and fMRI|When possible, the subject will undergo a post operative fMRI/ DTI scan as well as clinical language testing. If the subject develops CMS, the second fMRI will be performed as soon as possible. Some subjects may be severely impaired or have difficulty performing fMRI and clinical language testing tasks. In these instances, the fMRI and language testing may not be performed, or we may choose to perform resting state or passive fMRI tasks instead.
16156113|NCT01733147|Drug|Omega-3 free fatty acids|Baseline assessment: Measure waist and hip circumference, height, weight. Complete Gastroesophageal Reflux Questionnaire (GERQ). Blood draw for serum free fatty acid (FFA) profile. Clinical baseline blood draw: INR, LDL, AST and ALT. Single slice CT of abdomen. Endoscopy performed with biopsies, brushings, and mucosal impedance testing. Randomized to ω3 FFA preparation or placebo for six months. Telephone calls will be made every month to subjects to assess for adverse effects and reinforce compliance. Repeat assessment at six months following randomization. This will include anthropometry (similar to baseline), a blood draw as outlined at baseline, and endoscopy with research biopsies as outlined at baseline. Subjects will also fill out the GERQ.
16156114|NCT01733147|Drug|Placebo|Baseline assessment: Measure waist and hip circumference, height, weight. Complete Gastroesophageal Reflux Questionnaire (GERQ). Blood draw for serum free fatty acid (FFA) profile. Clinical baseline blood draw: INR, LDL, AST and ALT. Single slice CT of abdomen. Endoscopy performed with biopsies, brushings, and mucosal impedance testing. Randomized to ω3 FFA preparation or placebo for six months. Telephone calls will be made every month to subjects to assess for adverse effects and reinforce compliance. Repeat assessment at six months following randomization. This will include anthropometry (similar to baseline), a blood draw as outlined at baseline, and endoscopy with research biopsies as outlined at baseline. Subjects will also fill out the GERQ.
16156115|NCT01733134|Drug|Tolvaptan|Tolvaptan 30 mg. tablet for subjects enrolled prior to first 8 hours of coming to an emergency department. Repeated daily up to 5th day.
16156116|NCT01733134|Drug|placebo|Patient in the placebo group will receive tolvaptan in addition to standard therapy
16156117|NCT01733121|Drug|NBI-98854|25 mg capsule
16156118|NCT01733121|Drug|NBI-98854|50 mg capsule
16156119|NCT01733121|Drug|Placebo|
16156120|NCT01733108|Drug|Glyburide|One 1.25 mg tablet taken orally (by mouth) on Day 1 and Day 9.
16156121|NCT01733108|Drug|Canagliflozin (JNJ-28431754)|One 200 mg tablet taken orally (by mouth) on Days 4 through 9.
16156122|NCT01733095|Drug|ambrisentan|Ambrisentan (Volibris 5 mg film-coated tablets, Glaxo Smith-Kline) will be started at 5 mg every other day and increased to 5 mg daily after 4 weeks if tolerated well.
16156123|NCT01733069|Device|APTIMA COMBO 2 Assay (AC2 Assay)|APTIMA COMBO 2 Assay (AC2 Assay
16156124|NCT01733056|Biological|Flu Vaccine|Administration of Fluzone (Influenza Vaccine)
16156125|NCT01733043|Drug|Dexmedetomidine|
16156126|NCT01733043|Drug|Placebo|
16156127|NCT01733030|Drug|Seromycin|250 mg versus 500 mg versus placebo effects on conditioned fear generalization
16156128|NCT01733030|Drug|Seromycin|
16156129|NCT01733017|Behavioral|Sodium reduction|Teaching and skill building to reduce dietary sodium
16156130|NCT01733017|Dietary Supplement|omega 3 and lycopene supplements|omega-3 fatty acid supplements and juices containing lycopene
16156131|NCT01733017|Dietary Supplement|rice bran oil capsules|placebo capsules
16156132|NCT01733017|Behavioral|Generic dietary feedback from|Provided a summary of the 3 day dietary recalls at baseline, 3 months, and 6 months
16156133|NCT01733004|Drug|MM-141|
16156134|NCT01732991|Device|prostatic photo-vaporization (PVP)|Prostatic photo-vaporization using a lithium laser of 532nm wavelength (GREEN-LIGHT XPS™,American Medical Systems, Minnetonka, MN, USA) emitting by a fiber MoXy™ a maximum power of 180 W continuously. Using common practice and according to the CE labelling.
16156135|NCT01732978|Behavioral|Crying record|"Recording spontaneous crying is as soon as possible after birth. Crying is recorded twice during the first week of life.
~Listening tests:
~Tests will be conducted playbacks with the father and mother separately, and with a staff"
16156136|NCT01732965|Other|Phototherapy|
16156137|NCT01732965|Other|Phototherapy and Photochemotherapy|
16156138|NCT01732926|Drug|Idelalisib|150 mg tablet administered orally twice daily
16156139|NCT01732926|Drug|Rituximab|375 mg/m^2 single-use vials administered intravenously every 4 weeks (up to a total of 6 infusions)
16156140|NCT01732926|Drug|Bendamustine|90 mg/m^2 single-use vials administered intravenously for two consecutive days every 4 weeks (up to a total of 4-6 cycles as tolerated)
16156141|NCT01732926|Drug|Placebo|Tablet administered orally twice daily
16156142|NCT01732913|Drug|Placebo|Tablets administered orally twice daily
16156143|NCT01732913|Drug|Rituximab|375 mg/m^2 administered intravenously weekly for 4 weeks, then every 8 weeks (up to a total of 8 infusions)
16156144|NCT01732913|Drug|Idelalisib|150 mg tablets administered orally twice daily
16156145|NCT01732900|Other|Morphology|Embryos selected for transfer will be based upon morphology alone.
16156146|NCT01732900|Other|GemART assay|Embryos selected for transfer will be based upon morphology and GemART assay.
16156147|NCT01732887|Other|Cognitive fitness training|"Computer-based training of basic cognitive functions. It has activities under two headings,
~General training applications
~Memory training applications
~Each individual session in both groups will include playing specific computer games for at least 1/2 hour a day, 3 days per week, throughout the 10 week interval."
16156148|NCT01732874|Drug|Expecta 200 mg|Breastfeeding mothers who have given birth to premature infant 29 weeks or less will be randomized to receive 200mg Expecta. They will take once a day for 8 weeks or a shorter time if infant is discharged sooner from NICU.
16156149|NCT01732874|Drug|Expecta 1 gram|Breastfeeding mothers who have given birth to premature infant 29 weeks or less will be randomized to receive 1 gram of Expecta. They will take once a day for 8 weeks or a shorter time if infant is discharged sooner from NICU.
16156150|NCT01732861|Drug|CC-292|CC-292-will be given twice daily on Days 8-28 of Cycle 1 and on Days 1-28 of the remaining 28-day cycles.
16156151|NCT01732861|Drug|Lenalidomide|Lenalidomde will be given once daily on Days 1-28 of 28-day cycles.
16156152|NCT01732848|Drug|BMS-986094/INX-08189|
16156153|NCT01732848|Drug|Placebo matching BMS-986094/INX-08189|
16156154|NCT01732835|Device|HAART 300 Annuloplasty Device|Implantation of HAART 300 Annuloplasty Device for aortic valve repair
16156155|NCT01732822|Drug|Ticagrelor|Ticagrelor 90 mg bd (and Clopidogrel placebo od) taken orally as tablets
16156156|NCT01732822|Drug|Clopidogrel|Clopidogrel 75 mg od (and Ticagrelor placebo bd) taken orally as tablets
16156157|NCT01732809|Drug|AbobotulinumtoxinA (ABO)|Isovolumetric (0.02 mL) doses of 2 units of abobotulinumtoxinA injected on one side of the forehead.
16156158|NCT01732809|Drug|OnabotulinumtoxinA (ONA)|Isovolumetric (0.02 mL) doses of 2 units of onabotulinumtoxinA injected on the other side of the forehead.
16156159|NCT01732796|Drug|Ribavirin (RBV)|24 weeks of active RBV
16156160|NCT01732796|Drug|BI 201335 (Faldaprevir)|16 weeks of BI 201335 followed by 8 weeks placebo to BI 201335
16156161|NCT01732796|Drug|Ribavirin (RBV)|24 weeks of active RBV
16156162|NCT01732796|Drug|BI 207127|24 weeks of BI 207127
16156163|NCT01732796|Drug|BI 201335 (Faldaprevir)|24 weeks of BI 201335
16156164|NCT01732796|Drug|Ribavirin (RBV)|16 weeks of Ribavirin followed by 8 weeks of placebo to Ribavirin
16156165|NCT01732796|Drug|BI 207127|16 weeks BI 207127 followed by 8 weeks placebo to BI 207127
16156166|NCT01732796|Drug|Faldaprevir (BI 201335)|24 weeks of 201335
16156167|NCT01732796|Drug|BI 207127|24 weeks of BI 207127
16156168|NCT01732783|Other|Panitumumab + Chemotherapy|Participants receiving panitumumab in combination with chemotherapy as prescribed by the treating physician prior to enrollment in this study and according to routine clinical practice for patients with wild-type RAS metastatic colorectal cancer.
16156169|NCT01732770|Biological|Denosumab|Denosumab 60 mg administered by subcutaneous injection once every 6 months.
16156170|NCT01732770|Drug|Zoledronic Acid|Zoledronic acid 5 mg administered by intravenous infusion once a year
16156171|NCT01732770|Drug|Placebo to Denosumab|Administered by subcutaneous injection once every 6 months
16156172|NCT01732770|Drug|Placebo to Zoledronic Acid|Administered by intravenous infusion once a year
16156173|NCT01732757|Drug|Alcaftadine 0.25%|One drop of Lastacaft® (Alcaftadine 0.25%) administered in both eyes on Day 0.
16156174|NCT01732757|Drug|Olopatadine 0.2%|One drop of Pataday™ (Olopatadine 0.2%) administered in both eyes on Day 0.
16156175|NCT01732757|Drug|dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%|One drop of placebo (dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%) administered in both eyes on Day 0.
16156176|NCT01732744|Other|Physiological solution|The volunteers were instructed to brush the internal surface of complete dentures for 2 minutes, 3 times a day, after meals (breakfast, lunch and dinner) and use the following chemical immersion methods, only once a day after dinner: A - Control (Co): Physiological solution, for 20 minutes. B) 1% Sodium Hypochlorite, for 20 minutes. C) Polident Alkaline Peroxide, for 3 minutes. D) 2,0% Castor bean solution Ricinus communis, for 20 minutes. In addition, the participants were instructed to immerse their dentures in water during the night period, before going to sleep.
16156177|NCT01732744|Other|Sodium hypochlorite|The volunteers were instructed to brush the internal surface of complete dentures for 2 minutes, 3 times a day, after meals (breakfast, lunch and dinner) and use the following chemical immersion methods, only once a day after dinner: A - Control (Co): Physiological solution, for 20 minutes. B) 1% Sodium Hypochlorite, for 20 minutes. C) Polident Alkaline Peroxide, for 3 minutes. D) 2,0% Castor bean solution Ricinus communis, for 20 minutes. In addition, the participants were instructed to immerse their dentures in water during the night period, before going to sleep.
16156178|NCT01732744|Other|Alkaline Peroxide|The volunteers were instructed to brush the internal surface of complete dentures for 2 minutes, 3 times a day, after meals (breakfast, lunch and dinner) and use the following chemical immersion methods, only once a day after dinner: A - Control (Co): Physiological solution, for 20 minutes. B) 1% Sodium Hypochlorite, for 20 minutes. C) Polident Alkaline Peroxide, for 3 minutes. D) 2,0% Castor bean solution Ricinus communis, for 20 minutes. In addition, the participants were instructed to immerse their dentures in water during the night period, before going to sleep.
16156179|NCT01732744|Other|Castor bean solution|The volunteers were instructed to brush the internal surface of complete dentures for 2 minutes, 3 times a day, after meals (breakfast, lunch and dinner) and use the following chemical immersion methods, only once a day after dinner: A - Control (Co): Physiological solution, for 20 minutes. B) 1% Sodium Hypochlorite, for 20 minutes. C) Polident Alkaline Peroxide, for 3 minutes. D) 2,0% Castor bean solution Ricinus communis, for 20 minutes. In addition, the participants were instructed to immerse their dentures in water during the night period, before going to sleep.
16156180|NCT01732731|Other|treadmill training|Home-based treadmill training will be administered to the children in the experimental group
16156181|NCT01732718|Drug|Atorvastatin|40 mg tablet by mouth daily for 6 weeks
16156182|NCT01732718|Drug|Placebo|Matching placebo tablet by mouth daily for 6 weeks
16156183|NCT01732705|Behavioral|High intensity interval training|HIT will be conducted as 2 weeks of one legged high intense interval training (8 sessions every 2nd day). Each training session will consist of 10 x 1 min intervals on ergometer bicycle interspersed with 1 min recovery.
16156184|NCT01732692|Drug|MOVIPREP|MOVIPREP solution
16156185|NCT01732679|Other|rehabilitation|Description of specialized rehabilitation and Influence on activities, life satisfaction, psycho social aspects 6 and 12 months post discharge
16156186|NCT01732666|Drug|Nefopam|20 mg of Nefopam mixed in 100 ml of 0.9% saline IV immediately after induction of anesthesia.
16156187|NCT01732666|Drug|low dose remifentanil|100 ml of 0.9% saline immediately after anesthesia induction and 0.05µg/kg/min of remifentanil during anesthesia.
16156188|NCT01732666|Drug|high dose remifentanil|100 ml of 0.9% saline immediately after anesthesia induction and 0.3 µg/kg/min of remifentanil during anesthesia.
16156189|NCT01732653|Other|TT+VR|subjects will be walking on a treadmill while negotiating virtual obstacles provided by a computer simulation. The virtual environment will consist of obstacles, different pathways, narrow corridors and distracters, requiring modulations of step amplitude in two planes (i.e., height and width) coordinated with walking behaviour. The speed, orientation, size, frequency of appearance and shape of the targets will be manipulated according to individual needs following a standardized protocol.
16156190|NCT01732653|Other|TT alone|The participants will walk on the treadmill, their gait speed over-ground will be measured at the beginning of each week of training. Progression will include increasing the duration of each of the walking bouts and increasing walking speed.
16156191|NCT01732640|Drug|Afatinib|Afatinib will be supplied as film-coated tablets. Available dosage strengths will be 20, 30, or 40 mg. Tablets will be supplied in HDPE, child-resistant, tamper-evident bottles.
16156192|NCT01732640|Drug|Paclitaxel|Induction chemotherapy: 175 mg/m2 day 1 every 21 days for 2 cycles (IV infusion as per institutional standard).
16156193|NCT01732640|Drug|Carboplatin|Carboplatin is available as a sterile lyophilized powder in single-dose vials containing 50 mg, 150 mg, or 450 mg of carboplatin. Each vial contains equal parts by weight of carboplatin and mannitol. Commercial supplies of carboplatin will be used in this trial.
16156194|NCT01732640|Drug|Cisplatin|Concurrent chemotherapy: 40 mg/m2 once weekly for 7 cycles (IV infusion as per institutional standard).
16156195|NCT01732640|Radiation|Intensity Modulated Radiation Therapy|Standard Fractionation 70 Gy /35 fractions at 2 Gy/day for 5 days per week.
16156196|NCT01732627|Biological|Meningococcal Polysaccharide (A, C, Y, and W 135) Tetanus Protein Conjugate Vaccine|0.5 milliliter (mL), Intramuscular (IM)
16156197|NCT01732627|Biological|Meningococcal Polysaccharide Vaccine, Groups A, C, Y, W 135 Combined|0.5 mL, Subcutaneous (SC)
16156198|NCT01732614|Procedure|Topcon Endpoint Management laser|
16156199|NCT01732601|Behavioral|Intensive Outpatient CBT|Sessions will be delivered 1-2 times a week for the first 4-6 weeks, based on need, and then weekly until 6 months. Therapy can continue up until one year.
16156200|NCT01732601|Behavioral|Standard Care|Treatment at step-down facilities
16156201|NCT01732588|Drug|OZ439 120mg PIB|120mg dose (as free base) of OZ439 as a solution made up from powder in bottle (PIB)
16156202|NCT01732588|Drug|120 mg OZ439 caplet|120 mg (as free base) of OZ439 immediate-release (IR) caplet formulation containing nanoparticulate, administered directly via the oral route
16156203|NCT01732588|Drug|120mg OZ439 caplet via Enterion capsule|120 mg OZ439 (as free base) in an immediate release (IR) caplet formulation containing nanoparticulate,administered orally via the Enterion capsule and delivered directly to the proximal small bowel (PSB)
16156204|NCT01732575|Behavioral|Enrichment with meaning-generating activities|Gaps in the rehabilitation are identified by staff and researchers in dialogue. Staff gets relevant education. An intervention is tailored by staff and researchers to bridge the gaps. Consumers have a say and the intervention is revised accordingly. The intervention is implemented and continues for 14 months.
16156205|NCT01732562|Other|Patient e-Learning educational tool|Web based site with videos of TKR surgical animation, demonstrations of exercises and activities following surgery and conversations with surgeons, physiotherapist, occupational therapist and patients.
16156206|NCT01732549|Drug|Tasquinimod|A patient's dose will escalate from one level to the next, once tolerability of the current dose is established. If tolerability issues arise at 0.5 or 1 mg/day, patients will have their dose reduced to 0.25 or 0.5 mg/day, respectively.
16156207|NCT01732549|Drug|Placebo|Placebo capsules are identical to tasquinimod capsules in appearance and excipients but exclude the active compound (tasquinimod), to be taken orally once a day with water and food
16156208|NCT01732536|Drug|S8 Sinus Implant|In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
16156209|NCT01732536|Procedure|Sham procedure|In-office bilateral sham procedure
16156210|NCT01732536|Drug|Mometasone furoate nasal spray|Two sprays in each nostril once daily, totaling 200 mcg of mometasone furoate throughout Day 90
16156211|NCT01732510|Drug|MK-8226|MK-8226 administered IV at a weight-based dose every 2 weeks for 12 weeks.
16156212|NCT01732510|Drug|Placebo|Placebo administered IV every 2 weeks for a period of 12 weeks.
16156213|NCT01732497|Device|miraDry Treatment|Application of electromagnetic energy to heat the lower dermis.
16156214|NCT01732484|Procedure|intraocular lens implantation|
16156215|NCT01732471|Drug|Kuvan®|Kuvan® (sapropterin dihydrochloride) will be administered orally at a dose of 20 milligram per kilogram per day (mg/kg/day) once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment will be continued at the same dose for further 6 weeks.
16156216|NCT01732458|Drug|Aprepitant|Administered as a single oral dose on Day 1 between 1 and 3 hours prior to expected induction of anesthesia. Aprepitant was supplied in a sachet containing a powder for suspension (PFS) that was reconstituted up to total volume of 5 mL using potable water.
16156217|NCT01732458|Drug|Placebo to Aprepitant|
16156218|NCT01732458|Drug|Ondansetron|Administered IV at a dose of 4 mg for participants >40 kg in weight and 0.1 mg/kg for participants ≤40 kg in weight. In participants <1 month of age, the dose of ondansetron was administered per the product label or based on local standard of care. Ondansetron was supplied by the Sponsor as vials or ampules, depending on the country.
16156219|NCT01732458|Drug|Placebo to match ondansetron|Participants in the aprepitant regimen received normal saline IV (provided by the site) as the placebo for ondansetron on Day 1, immediately prior to induction of anesthesia.
16156220|NCT01732445|Drug|ruxolitinib phosphate|Given PO
16156221|NCT01732445|Drug|danazol|Given PO
16156222|NCT01732445|Other|quality-of-life assessment|Ancillary studies
16156223|NCT01732445|Other|questionnaire administration|Ancillary studies
16156224|NCT01732419|Behavioral|Home-based training|Home-based exercise training for cardiac patients.
16156225|NCT01732419|Behavioral|Centre-based training|Usual exercise training in an outpatient setting.
16156226|NCT01732393|Drug|oral quercetin capsules|10 cases in case group and 10 cases in control group. Patients in the intervention group were administered two, 250 mg Quercetin capsules daily for 3 weeks. Patients in the placebo group received two placebo capsules containing lactose .Patients were examined every other day for evaluation of initiation and severity of oral mucositis.
16156227|NCT01732393|Drug|Placebo|
16156228|NCT01732380|Drug|Raltitrexed|
16156229|NCT01732380|Drug|Oxaliplatin|
16156230|NCT01732380|Radiation|Radiotherapy|
16156231|NCT01732367|Drug|Lamivudine plus adefovir|Lamivudine 100mg QD for 96 weeks + Adefovir 10mg QD for 96 weeks
16156232|NCT01732367|Drug|Tenofovir|Tenofovir 300mg QD for 96 weeks
16156233|NCT01732341|Device|STENTYS self-apposing stent|Intervention to treat STEMI with the STENTYS self-apposing stent
16156234|NCT01732341|Device|VISION balloon-expandable stent|"STEMI treatment with a VISION balloon-expandable stent
~--------------------------------------------------------------------------------"
16156235|NCT01732328|Dietary Supplement|Calcium plus vitamin D|
16156236|NCT01732315|Behavioral|Email Notification|This study will use a targeted email reminder/recall intervention that addresses specific aspects of adolescent under-immunization.
16156237|NCT01732302|Other|Educational intervention|Primary health care centers (PHCC) in the intervention group will be visited twice by a pharmacist within a period of three months. At the first visit, an educational intervention will focus on two properties: on the one hand, feed-back of actual patient data of the PHCC illustrating the primary-health-care-specific characteristics of inappropriate prescribing in the elderly patient will be given. Education of relevant subjects will be given in relation to detected problems. On the other hand, a clinical routine regarding the performance of drug utilization reviews will be developed in cooperation with the health care providers. At the second visit 3 months later, the developed concept will be critically reviewed and eventually developed further.
16156238|NCT01732289|Genetic|genes|Draw blood for genetic screening
16156239|NCT01732276|Drug|gefitinib|
16156240|NCT01732263|Drug|SSP-004184|All subjects will take a single oral dose of SSP-004184 (SPD602) (50 mg/kg) on Day 1
16156241|NCT01732250|Drug|Colistin|IV Colistin with loading dose of 9 mil IU units, Maintenance dose 4.5 mil IU q12h, adjusted for renal function, for 10 days.
16156242|NCT01732250|Drug|Meropenem|IV meropenem, 2 gram q8h, adjusted for renal function, for up to 10 days.
16156243|NCT01732237|Drug|JNJ-42396302|A single dose of JNJ-42396302 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.
16156244|NCT01732237|Drug|JNJ-42692507|A single dose of JNJ-42692507 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.
16156245|NCT01732237|Drug|JNJ-53773187|A single dose of JNJ-53773187 100 micrograms (1 mL) will be administered orally with 240-mL non-carbonated water.
16156246|NCT01732224|Drug|Tenofovir + Telbivudine|Tenofovir (300 mg/day) plus telbivudine (600 mg/day).
16156247|NCT01732224|Drug|Tenofovir|In tenofovir arm subjects will receive tenofovir (300 mg) once daily.
16156248|NCT01732211|Biological|PD 0360324|100 mg Q2W or 150 mg Q2W via intravenous infusion based on protocol determined dose escalation/de-escalation criteria; 12 weeks Active Therapy;
16156249|NCT01732211|Other|Normal Saline for injection|normal saline Q2W via intravenous infusion for 12 weeks
16156250|NCT01732198|Biological|NU300|
16156252|NCT01732198|Biological|Prevnar 13|
16156253|NCT01732185|Genetic|Patient|Blood and histological samples will be done at day of the inclusion.
16156254|NCT01732172|Other|Sperm sample|Sperm sample
16156255|NCT01732159|Other|Checklist|he checklist will be administered to the patients by phone between 7 and 3 days before the surgery
16156256|NCT01732146|Drug|erythropoietin Beta|erythropoietin intravenous injection (5000 U/ 0.3 ml)1000 to 1500 U/kg/dose X 3 given every 24 hours with the first dose within 12 hours of delivery
16156257|NCT01732146|Drug|Placebo|
16156258|NCT01732133|Device|Nexfin|
16156259|NCT01732120|Procedure|Off-clamp partial nephrectomy|
16156260|NCT01732107|Drug|Dovitinib|Dovitinib will be administered 500mg orally in a 5 days on, 2 days off dosing schedule. Day 12 assessments are intended to be performed on the last dosing day of the 2nd week in cycle 1 and cycle 2 and day 26 assessments are intended to be performed on the last dosing day of the 4th week in cycle 1 and cycle 2.
16156261|NCT01732094|Drug|Triptorelin|Triptorelin 0.1 mg/1 ml solution daily from day 21 of the cycle onwards
16156262|NCT01732094|Drug|Corifollitropin alfa 150μg|Corifollitropin alfa 150μg (single dose) 2 or 3 weeks after initiation of triptorelin
16156263|NCT01732094|Drug|hpHMG|hpHMG 300IU daily from day 7 following Corifollitropin alfa onwards
16156264|NCT01732068|Drug|Triptorelin|Triptorelin 0.1 mg/1 ml solution daily from day 1 or 2 of the cycle onwards
16156265|NCT01732068|Drug|Corifollitropin alfa|Corifollitropin alfa 150μg (single dose) on day 2 or 3 of the cycle
16156266|NCT01732068|Drug|hpHMG|300IU hMG daily from day 7 following Corifollitropin alfa until the day of ovulation triggering
16156267|NCT01732055|Behavioral|Partner-Assisted Interpersonal Psychotherapy|
16156268|NCT01732055|Other|Treatment as Usual|Because treatment(s) are prescribed for subjects by the UNC Perinatal Psychiatry physicians, it is impossible for the investigators to list each potential medication and dosage that might be prescribed to women randomized to this condition. The medication regimens are individual, and some women may opt against medication altogether (and still be eligible to enroll). Women who refuse antidepressant medication will attend visits at the same intervals as those in the study arms for evaluation of safety and symptoms.
16156269|NCT01732029|Other|Normobaric hypoxia chamber|
16156270|NCT01732016|Other|Normobaric hypoxia chamber|
16156271|NCT01732003|Dietary Supplement|Omega-3 Complete|
16156272|NCT01732003|Dietary Supplement|Placebo Pill|
16156273|NCT01731990|Drug|Canakinumab (ACZ885)|Dosage form: solution for injection Strength: 150 mg/1 mL Mode of administration: subcutaneous use.
16156274|NCT01731990|Drug|Placebo|Matching placebo of Canakinumab
16156275|NCT01731977|Behavioral|Strengths-based family psychoeducation|Family psychoeducation in a group setting is performed every two weeks for eight weeks.
16156276|NCT01731964|Device|Telescope prosthesis|Monocular implantation of the telescope prosthesis after cataract extraction
16156277|NCT01731964|Device|WA-NG Telescope Prothesis|The WA-NG telescope prosthesis (Figure 1) is the next generation telescopic implantable device which, when combined with the optics of the cornea, constitutes a telephoto system for improvement of visual acuity in patients with severe to profound vision impairment due to bilateral, end-stage age-related macular degeneration. The device is implanted in one of the patient's eyes. In this way, the implanted eye provides central vision and the non-implanted eye can continue to provide peripheral vision.
16156278|NCT01731951|Drug|Imetelstat|Imetelstat sodium administered as IV over 2 hours with treatment as long as participants derive clinical benefit or until end of study.
16156279|NCT01731938|Biological|Fibrin Sealant (FS) Grifols|Fibrin Sealant (FS) Grifols: The maximum total volume of FS Grifols allowed to be applied at the target bleeding site by dripping or spraying was approximately 12 mL (equivalent to the full content of 2 FS Grifols kits).
16156280|NCT01731938|Device|Surgicel®|Up to four Surgicel® sheets applied to the target bleeding site according to Package Insert instructions and the surgeon's usual clinical practice.
16156281|NCT01731925|Drug|Lanreotide|Lanreotide at the dose of 120 mg will be injected every 28 days as the reference treatment to control the carcinoid syndrome in both arms.
16156282|NCT01731925|Drug|Placebo (for sunitinib)|
16156283|NCT01731925|Drug|Sunitinib|Sunitinib 37.5 mg daily
16156284|NCT01731912|Drug|Degarelix|Given SC
16156285|NCT01731912|Radiation|External Beam Radiation Therapy|Undergo standard EBRT
16156286|NCT01731912|Other|Laboratory Biomarker Analysis|Correlative studies
16156287|NCT01731899|Drug|agomelatine|Agomelatine 25 mg pills. Initial dose 25 mg at bedtime; can be increased up to 50 mg at bedtime; 12 weeks duration
16156288|NCT01731886|Procedure|Autologous peripheral blood stem cell transplant|Subjects deemed suitable by the principal investigator will undergo autologous peripheral blood stem cell transplantation on day 0.
16156289|NCT01731886|Drug|Lenalidomide|Administered orally at a dose 25 mg daily on days 1-21 of each 28-day cycle.
16156290|NCT01731886|Drug|Dexamethasone|Administered orally at a dose of 40 mg daily on days 1, 8, 15, 22 of each cycle.
16156291|NCT01731886|Procedure|Stem cell collection|Peripheral stem cell collection will be performed at marrow recovery, usually when white blood cell (WBC) is >2500 x 109 cells/liter; platelet count is >20 x 103/mm3.
16156292|NCT01731886|Drug|Melphalan|Subjects undergoing autologous peripheral blood stem cell transplant will receive melphalan 200 mg/m2 intravenously on days -2 and -1 or only on day -2.
16156293|NCT01731886|Drug|G-CSF|Subjects will receive G-CSF subcutaneously daily beginning on day 5 and until blood counts recover.
16156294|NCT01731886|Drug|Cyclophosphamide|Subjects may receive up to the maximum recommended high-dose of cyclophosphamide at 4 gm/m2 intravenously.
16156295|NCT01731886|Drug|Mesna|Mesna will be provided with the cyclophosphamide.
16156296|NCT01731860|Device|Additional PET Scan|Additional PET Scan with no additional radiopharmaceutical administration.
16156297|NCT01731847|Procedure|the combination group|Patients received 12 sessions of NMES for 1 hour /day, 5 days/week within a period of 2-3 weeks. FEES was done before and after NMES for evaluation and guiding therapy. All patients subsequently received 12 sessions of traditional swallowing rehabilitation (50 minutes/day, 3 days/week) for 4 weeks.
16156401|NCT01730911|Other|Text message|Participants will receive daily text messages to report bleeding and cramping experienced, if they are randomized to this arm.
16156402|NCT01730898|Other|Study product containing lutein|delivered in capsule form
16156298|NCT01731834|Other|Vibrocompression and aspiration of secretions|The 20 children, study participants will be randomly assigned to different groups, where 10 children will be evaluated during vibrocompression maneuver, and another 10 will be assessed on the aspiration procedure. Randomization will be performed using an opaque envelope for specifying which group selection technique is evaluated.
16156299|NCT01731821|Procedure|pancreaticojejunostomy|"Nonstented stump closed pancreaticojejunostomy:
~Close the pancreatic stump with interrupted inverting sutures around the papillary-like pancreatic duct.
~A small full-thickness enterotomy was penetrated on the jejunal wall for connecting to the papillary-like pancreatic duct by placing 4-6 sutures from the periductal parenchyma to the whole-layer jejunum hole. After that, interrupted sutures between the front wall of pancreatic stump and the seromuscular jejunum were performed by 4-0 absorbable sutures to complete the anastomosis.
~Duct-to-mucosa pancreaticojejunostomy:Two layer anatomosis with Duct-to-Mucosa pancreaticojejunostomy is performed by suturing the pancreatic parenchyma to the jejunal seromuscular layer and no stenting tube was used."
16156300|NCT01731808|Behavioral|Nursing counseling|The participants who were randomized in the intervention group received outpatient physician-prescribed wound care. Additionally, they received standardized education regarding diabetic foot care. The nurse-led outpatient intervention started a few days after randomization and went on for five weeks. The study nurses conducting the interventions were wound care nurses and trained in foot examination, foot care, education, and counseling. During a period of five weeks, the participants were provided with weekly, one-hour education, skill training, and counseling sessions on foot care. Each participant received a foot care kit with essential foot care material and a foot care diary.
16156301|NCT01731795|Drug|Dexamethasone|Dexamethasone (20 mg/iv/daily/from Day 1 of randomization during 5 days, followed by 10 mg/iv/daily/ from Day 6 to 10 of randomization)
16156302|NCT01731782|Drug|bupivacaine|
16156303|NCT01731782|Drug|normal saline placebo (for bupivacaine)|Normal saline to mimic bupivacaine
16156304|NCT01731769|Procedure|vacuum assisted closure in experimental arm|
16156305|NCT01731769|Procedure|Axillary dissection|
16156306|NCT01731756|Other|Leaf extract of A. indica|Leaf extract of A. indica plus 6% salicylic acid will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks.
16156307|NCT01731756|Drug|Salicylic Acid (6%)|Salicylic acid (6%) will be applied on palmer keratotic lesion once daily on bedtime for 12 weeks.
16156308|NCT01731756|Other|Petroleum jelly|Petroleum jelly will be applied on palmer keratotic lesion once daily at bedtime for 12 weeks.
16156309|NCT01731743|Device|AT LISA tri 839MP|
16156310|NCT01731730|Drug|Placebo Injection|3mL solution for intrathecal injection; Vehicle formulation designed to mimic AYX1 Injection (with no active drug)
16156311|NCT01731730|Drug|AYX1 Injection 110 mg|3mL solution for intrathecal injection with 110 mg of AYX1
16156312|NCT01731730|Drug|AYX1 Injection 330 mg|3mL solution for intrathecal injection with 330 mg of AYX1
16156313|NCT01731717|Behavioral|Active monitoring|General physician performs monitoring every 2 weeks using the PHQ-9 depression scale.
16156314|NCT01731717|Behavioral|Bibliotherapy|"Patient works with self-help book Selbsthilfe bei Depressionen (Görlitz, 2010) under general physician's supervision."
16156315|NCT01731717|Behavioral|Online self-help|"Patient works with online self-help program Deprexis under general physician's supervision."
16156316|NCT01731717|Behavioral|Outpatient psychotherapy|Patient receives outpatient psychodynamic or cognitive-behavioural psychotherapy from a psychotherapist participating in the network.
16156317|NCT01731717|Procedure|Psychiatric treatment|Patient receives treatment from psychiatrist or general physician participating in the network, this includes psychopharmacotherapy. Treatment takes place within routine care, thus psychiatrists or general physicians individually determine the type of medication and are committed to follow the recommendations of the German S3-Guideline/National Disease Management Guideline for Unipolar Depression.
16156318|NCT01731717|Behavioral|Combined psychotherapy and psychopharmacological treatment|Patient receives psychotherapy combined with psychopharmacological treatment, if necessary in inpatient setting.
16156319|NCT01731717|Other|Control group: treatment as usual|treatment as usual
16156320|NCT01731704|Radiation|Stereotactic radiosurgery (SRS)|
16156321|NCT01731704|Radiation|Whole brain radiation therapy (WBRT)|External beam whole-brain radiation therapy 30 Gy in 10 fractions. Treatment will be delivered once daily, 5 fractions per week, over 2 to 2.5 weeks
16156322|NCT01731691|Biological|α1 Proteinase Inhibitor|Prolastin-C treatment in HIV disease will be compared with placebo treatment in HIV disease and no treatment in uninfected volunteers.
16156323|NCT01731691|Drug|Placebos|Placebo treatment in HIV disease will be compared with Prolastin-C treatment in HIV disease and no treatment in uninfected volunteers.
16156324|NCT01731678|Procedure|Transcranial Magnetic Stimulation|The standardized treatment location will be the left DLPFC. Anatomical T1 images from the pre-intervention MRI will be loaded into our Transcranial Magnetic Stimulation (TMS) lab neuronavigation software (Brainsight2, Rogue Research, Montreal). Following 3D co-registration of the TMS coil with the patient's MRI images and head, the coil will be placed over the left DLPFC (tangential to scalp, angle of 45 degrees to midline). Interventional repetitive TMS (rTMS) (Magstim Rapid2, Wales, UK) will consist of 40 suprathreshold (120% RMT) pulses over 4 seconds (10 Hz) with an inter-train interval of 26 seconds. Treatment sessions will last 37.5 minutes (75 trains/3000 pulses). Treatments will occur on each weekday for three weeks (15 days total).
16156325|NCT01731652|Drug|TMX-101|
16156326|NCT01731639|Other|MSOME|The semen samples will be evaluated according to the 2010 WHO reference values. After ICSI 200 spermatozoa of each sample will be analyzed under high magnification (MSOME - x6600) and graded into four groups according to the presence or size of the vacuoles. Grade I: normal form and no vacuoles; grade II: normal form and ≤ 2 small vacuoles; grade III: normal form > 2 small vacuoles or at least one large vacuole and grade IV: large vacuole and abnormal head shapes or other abnormalities.
16156327|NCT01731613|Dietary Supplement|human milk fortifier|Then fortification with human milk fortifier will be initiated at different levels according to the body weight of infants, the protein concentration of human milk and blood urea nitrogen
16156328|NCT01731600|Drug|turoctocog alfa pegol|Fixed dose of turoctocog alfa pegol for intravenous injections (i.v.) twice weekly for prophylaxis. In addition, turoctocog alfa pegol will be administered to treat bleeding episodes during the trial period. Bleeding episodes will be treated with doses of 20-75 U/kg body weight.
16156329|NCT01731587|Other|Biological: MUC1 peptide specific immunotherapy|Eight consecutive weekly subcutaneous administration with reconstituted L-BLP25 (containing 806 microgram of BLP25 lipopeptide) followed by administrations at 6-week intervals, commencing at Week 14, until disease progression is documented.
16156330|NCT01731587|Drug|Cyclophosphamide (CPA)|A single intravenous infusion of 300 milligram per square meter (to a maximum of 600 milligram) of CPA will be given three days before the first L-BLP25 administration.
16156331|NCT01731574|Drug|dapivirine|
16156332|NCT01731574|Drug|miconazole|
16156333|NCT01731561|Drug|Rituximab (Arm B)|Rituximab infusion will be performed at D1 then ANCA status and CD19+ lymphocyte count will be monitored every 3 months, and patients will receive new 500 mg rituximab infusions either if CD19 are > to 0/mm3, or if ANCA are positive again or if ANCA titer significantly raises. All patients received corticosteroids, starting from induction with prednisone (or equivalent) at a dose of 1 mg/kg/day with gradual tapering according to a regimen adjusted to body weight over a mean of 18 months since diagnosis.
16156334|NCT01731561|Drug|Rituximab (Arm A)|Rituximab infusion will be performed at D1, D15, M6, M12 and M18(i.e. a total of 5 infusions), at the dose of 500 mg at a fixed dosage.All patients received corticosteroids, starting from induction with prednisone (or equivalent) at a dose of 1 mg/kg/day with gradual tapering according to a regimen adjusted to body weight over a mean of 18 months since diagnosis.
16156335|NCT01731548|Radiation|hyperfractionated radiation therapy for both arms|1.5 Gy twice daily to 45 Gy in 30 fractions over 3 weeks for both arms
16156336|NCT01731522|Behavioral|EF condition|
16156337|NCT01731509|Other|Fetal endoscopic tracheal occlusion|FETO will be performed by placing a detachable balloon inside fetal trachea
16156338|NCT01731496|Other|Telephone reminder|One week prior to when a child is due for either their 2nd or 3rd HPV vaccine, their parent will receive a telephone reminder to call to make an appointment to receive their next dose. A total of 3 reminders will be sent.
16156339|NCT01731496|Other|Text Message reminder|One week prior to when a child is due for either their 2nd or 3rd HPV vaccine, their parent will receive a text message reminder to call to make an appointment to receive their next dose. A total of 3 reminders will be sent.
16156340|NCT01731470|Biological|Liposomes|Intravesical instillation of liposomes.
16156341|NCT01731457|Drug|etanercept|adding appropriate dose of etanercept to the perfusion fluid
16156342|NCT01731444|Drug|Phenylephrine|
16156343|NCT01731431|Other|Insulin|
16156344|NCT01731431|Drug|Glyburide|
16156345|NCT01731418|Behavioral|Narrative Exposure Therapy|Narrative Exposure Therapy (NET) is a treatment approach that was developed by a research group of the University of Konstanz (Schauer, Neuner, & Elbert, 2005, 2011). In NET, the patient repeatedly talks about the most arousing traumatic events in detail while re-experiencing the emotions associated with this event. In the process, the patient constructs a narration of his life, focusing on the detailed report of the traumatic experiences.
16156346|NCT01731418|Other|Treatment-as-usual|"Treatment-as-usual was defined as the commonly used psychotherapy for abused women in Iran, such as medical therapy and/or supportive counseling.
~Regarding supportive counselling, the sessions included:
~Life skill education CBT techniques ACT techniques Finding resources to stop violence Discussing marital and sexual conflicts with the presence of husbands Working on their children problems Improvement of communication skills"
16156347|NCT01731392|Dietary Supplement|Milk with Bifidobacteria|A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.
16156348|NCT01731392|Dietary Supplement|Milk with non replicating lactobacilli|A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.
16156349|NCT01731392|Dietary Supplement|placebo|A total of 36g (4 spoons) of powder milk per serving are diluted in 220 ml of water. Two servings per day are consumed orally, corresponding to 72g per day.
16156350|NCT01731379|Procedure|Surgical resection|Patients planned for elective inguinal, axillary or cervical lymph node dissection or parotidectomy , patients with rectal cancer undergoing rectal surgery and patients undergoing resection of a soft tissue tumour.
16156351|NCT01731366|Other|Whole grain|Whole grain diet: Participants consume more than 75g of whole grain per day (corresponds to the whole grain intake of the 90th percentile of the population)
16156352|NCT01731366|Other|Refined grain|Refined grain diet: Participants consume less than 10 g of whole grain per day (corresponds to the whole grain intake below the 10th percentile of the population)
16156353|NCT01731340|Dietary Supplement|Calcium Citrate|750mg
16156354|NCT01731340|Other|Low Dietary Calcium|450 mg
16156355|NCT01731340|Other|High Dietary Calcium|1200 mg
16156356|NCT01731327|Drug|tofacitinib modified-release (MR) formulation|A single dose of 11 mg tofacitinib modified-release (MR) administered in a fasting state.
16156357|NCT01731327|Drug|tofacitinib modified-release (MR) formulation|A single dose of 22 mg tofacitinib modified-release (MR) administered in a fasting state.
16156358|NCT01731314|Behavioral|Learning and Memory of Pain|
16156359|NCT01731301|Drug|Ribavirin|Ribavirin monotherapy will be started at a dose of 100 mg daily. After each successive week the dose of ribavirin will be increased by 100 mg increments daily as long as the hemoglobin remains greater than 10 gm/dl and/or there has not been a decline in the hemoglobin by more than 2 gms/dl from the pretreatment baseline.
16156360|NCT01731301|Drug|Peginterferon|After the patient has remained on their maximal tolerated dose of ribavirin for 1 week peginterferon alpha-2b will be initiated at a dose of 1.0 mcg/kg/week. This dose was chosen because it is known to be equivalent in achieving SVR when compared to the 1.5 mcg/kg/dose and is associated with less bone marrow suppression. The dose of ribavirin will be adjusted as needed.
16156361|NCT01731301|Drug|Boceprevir|Boceprevir will be added after the patient is on stable doses of ribavirin and peginterferon. The dose of ribavirin will be adjusted as needed.
16156403|NCT01730898|Other|Study product containing lutein|delivered in capsule form
16156404|NCT01730885|Other|Comparison of different Blood Glucose Meters|
16156405|NCT01730872|Drug|Prednisolone Sodium Phosphate Ophthalmic Solution 1%|One drop in each eye, four times/day for 4 days.
16156406|NCT01730872|Drug|Tears Naturale II Ophthalmic Solution|one drop in each eye, four times/ day (QID) for 4 days
16156501|NCT01730027|Drug|montelukast|montelukast for 12 weeks
16157196|NCT01724684|Other|Usual care|
16156362|NCT01731275|Drug|E6011|A single ascending dose (SAD) administration of E6011 is administered to 8 groups as a 30-minute intravenous infusion at a dose of either 0.0006, 0.006, 0.04, 0.2, 1, 3, 6, or 10 mg/kg. Each participant in each group will receive a single-dose only once. The study drug will not be administered to more than two participants on the same day, and the second participant must start the study treatment after at least a 2-hour interval from the start of the study treatment in the first participant. The subsequent ascending dose groups will start approximately at least every 3 weeks following the study treatment in the first participant of each group.
16156363|NCT01731275|Drug|E6011 Matching Placebo|A SAD administration of E6011 Matching Placebo is administered to 2 participants in each of 8 groups as a 30-minute intravenous infusion at a placebo dose of either 0.0006, 0.006, 0.04, 0.2, 1, 3, 6, or 10 mg/kg. Each participant in each group will receive a single-dose only once. The study drug will not be administered to more than two participants on the same day, and the second participant must start the study treatment after at least a 2-hour interval from the start of the study treatment in the first participant. The subsequent ascending E6011 Matching Placebo dose groups will start approximately at least every 3 weeks following the study treatment in the first participant of each group.
16156364|NCT01731249|Biological|Placebo|10 actuations of placebo sublingual solution once daily 5 months a year and during 2 years
16156365|NCT01731249|Biological|Birch pollen allergen extract|Sublingual solution of Birch pollen allergen extract 300IR (10 actuations) once daily 5 months per year and during 2 years
16156366|NCT01731236|Dietary Supplement|Carnitine|Group 1: Carnitine supplement for 2 months, No antibiotics, no aspirin for 3 months (1 month prior and during study)
16156367|NCT01731236|Dietary Supplement|Choline|Group 2: Choline supplement for 2 months, No antibiotics, no aspirin for 3 months (1 month prior and during study)
16156368|NCT01731236|Drug|Antibiotics|Group 3: Carnitine or Choline for 2 months, antibiotic cocktail (Ciprofloxacin, Flagyl, Vancomycin, and Neomycin) for 1 week
16156369|NCT01731236|Drug|Choline and Aspirin|Group 4: Choline supplement for 2 months plus aspirin 81 mg for 3 months (1 month prior to starting the study and 2 months during the study).
16156370|NCT01731236|Drug|Carnitine and Aspirin|Group 5: Carnitine supplement for 2 months plus aspirin 81 mg for 3 months (1 month prior to starting the study and 2 months during the study).
16156371|NCT01731223|Behavioral|Group treatment for insomnia|Experimental: Group treatment of insomnia The intervention is a group treatment based on cognitive and behavioral changing methods. It is including seven sessions during 10 weeks. Each session last for 2 hours with a 20 minutes pause. The intervention includes psycho education about sleep. Methods as relaxation, coping with worry, sleep restriction, stimulus control, sleep hygiene, stress coping strategies, strategies for coping with daytime symptom, identify and reformulate negative and dysfunctional thoughts about sleep, daytime functioning and stress and strategies for reducing hypnotics.
16156372|NCT01731210|Device|implantation of the new LV lead: NANO system.|
16156373|NCT01731197|Dietary Supplement|Dry-Blended Beverage|
16156374|NCT01731184|Drug|Midazolam|Midazolam (Hypnovel) at 0.04 mg /kg with morphine titration (first bolus: 0.1 mg/kg then 3 mg every 5 minutes).
16156375|NCT01731171|Dietary Supplement|Probiotic Supplement|Probiotic Supplement 1 tablet by mouth daily
16156376|NCT01731171|Dietary Supplement|Inert Compound|Probiotic identical placebo 1 tablet by mouth daily
16156377|NCT01731158|Drug|Avastin in combination with Roferon-A|
16156378|NCT01731158|Drug|Afinitor|
16156379|NCT01731158|Drug|TKI: Sutent, Nexavar or Votrient|TKI
16156380|NCT01731145|Device|SNUMAP|Portable six-axis (tri-axial accelerometer and tri-axial gyroscope) motion sensing system
16156381|NCT01731132|Drug|Levonorgestrel IUD or Copper IUD|Women who initiate the use of an IUD at the time of the study.
16156382|NCT01731119|Drug|Latuda©|All subjects will be started on 20-40mg of Latuda© at night (suggested intake with food). Subsequently, the dose may be increased as clinically indicated and based on tolerability every 7 days by 20-40mg to a maximum of 160mg per day with food which may be given as a single or twice daily dose depending on participant's preference. The maintenance dose will be determined solely by the clinician in accordance with the best interests of each participant.
16156383|NCT01731093|Drug|AT-001|
16156384|NCT01731093|Drug|Placebo|
16156385|NCT01731067|Drug|Cocktail probe drugs|
16156386|NCT01731041|Drug|Ticagrelor 180mg|Patients will receive 180 mg of ticagrelor
16156387|NCT01731041|Drug|Ticagrelor 90mg|Patients will receive 90 mg of ticagrelor
16156388|NCT01731028|Drug|Somatropin|Somatropin powder and solvent for solution for injection
16156389|NCT01731015|Drug|Medical Grade Oxygen|At the study visits, MRI 'studies' will be performed using the same MR scanner (a 3.0-Tesla (T) TRIO MRI system (Siemens Medical Systems)). Lung morphology and function will be acquired using conventional 1H MRI followed by 1H MRI with oxygen as a gaseous contrast agent. For both series the subject will lie down in a supine position on the magnet bed with a standard 1H Torso coil for imaging. Subjects are scanned on room air and then the subjects are switched from room air to 100% oxygen and exhaled O2/CO2 are monitored (Oxigraf Capnograph) until steady state is achieved (in our experience ~ 1-2 minutes). The 100% oxygen MRI imaging is commenced (the average exposure time is usually 5-6 minutes with a maximum exposure of 15 minutes) after which the subjects are switched to room air. After steady state is achieved a second room air scan is completed.
16156390|NCT01731002|Drug|AR-13324 Ophthalmic Solution 0.01%|Administered to study eye, once daily (QD) in the evening (PM) for 28 days
16156391|NCT01731002|Drug|AR-13324 Ophthalmic Solution 0.02%|Administered to study eye, QD in the PM for 28 days
16156392|NCT01731002|Drug|Latanoprost ophthalmic solution 0.005%|Administered to study eye, QD in the PM for 28 days
16156393|NCT01730989|Dietary Supplement|Estromineral Serena Plus|
16156394|NCT01730989|Dietary Supplement|Estromineral|
16156395|NCT01730976|Dietary Supplement|Vitamin D 2,000 I.U.|
16156396|NCT01730950|Biological|bevacizumab|Staring within 14 days of randomization, IV 10mg/kg every two weeks until disease progression.
16156397|NCT01730950|Radiation|radiation therapy|Starting with second dose of bevacizumab, 35 Gy in 10 fractions of 3.5 Gy each delivered on consecutive treatment days (typically 5 fractions per week).
16156398|NCT01730937|Drug|sorafenib tosylate|Given PO
16156399|NCT01730937|Radiation|stereotactic body radiation therapy|Undergo SBRT
16156400|NCT01730924|Procedure|Pulmonary vein isolation using contact force sensing catheter|
16156407|NCT01730859|Other|Balance exercise and ankle taping|"Balance Exercises: The first group performed balance exercise which last for six weeks, 3 times a week, and 40 minutes each session. Each session started by several minutes of slow walking and progressive stretching of ankle, knee and hip muscles which was gradually increased in time and repetition. After that, balance exercises were performed.
~Ankle taping: In second group Ankle joint taping continued for 6 weeks and was renewed three times a week."
16156408|NCT01730846|Drug|Doxazosin 4mg/day|4 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.
16156409|NCT01730846|Drug|Placebo|Placebo
16156410|NCT01730846|Drug|Doxazosin 8mg/day|8 mg/day with 3-week lead-in medication period. Maintained at steady state for duration of the study. 5-day taper at the end of the study.
16156411|NCT01730833|Biological|pertuzumab|Given IV
16156412|NCT01730833|Biological|trastuzumab|Given IV
16156413|NCT01730833|Drug|paclitaxel albumin-stabilized nanoparticle formulation|Given IV
16156414|NCT01730833|Other|laboratory biomarker analysis|Optional correlative studies
16156415|NCT01730807|Device|IntellaTip MiFi XP Catheter|Temperature controlled ablation catheter
16156416|NCT01730794|Other|NAVA ventilation|Neurally adjusted ventilatory assist
16156417|NCT01730794|Other|Conventional Lung Protective Ventilation|conventional protective mechanical ventilation
16156418|NCT01730781|Radiation|[11-C]OMAR|The radiotracer, [11-C]OMAR will be administered at no more than 10 micrograms at the beginning of each PET scan.
16156419|NCT01730768|Drug|AQW051|
16156420|NCT01730768|Drug|Placebo|
16156421|NCT01730755|Drug|Ruxolitinib|Ruxolitinib 10 mg tablets twice daily
16156422|NCT01730742|Behavioral|Neuroeconomics task|After a night of wakefulness, participants performed the neuroeconomics task (shopping food items in a mock supermarket scenario).
16156423|NCT01730742|Behavioral|Portion Size Task|Participants are given a computer program that gives them the opportunity to choose the portions of a variety of food items that they would ideally like to consume
16156424|NCT01730742|Procedure|Blood sample|After a night of wakefulness, a blood sample was taken to assess the level and efficacy of circulating neutrophils, as well as to assay blood serum and plasma for the presence of hormones involved in hunger such as oxytocin and ghrelin
16156425|NCT01730729|Drug|cabergoline|Given orally
16156426|NCT01730716|Device|Human spinal cord stem cell implantation|Human spinal cord stem cell implantation in ALS patients.
16156427|NCT01730677|Drug|Lapatinib|lapatinib 1000mg, once daily
16156428|NCT01730677|Drug|Vinorelbine|Vinorelbine 20mg/m2, D1 and D8, every 3 weeks
16156429|NCT01730664|Drug|ertapenem|single dose of 2000mg ertapenem IV
16156430|NCT01730651|Radiation|Tomotherapy|"IMRT boost of gross LNs
~Tomotherapy fraction size (Gy) = 0.4 x 진단 당시의 LN short diameter (cm) + 1.6 (pilot study range, 1.5-3.0 Gy)
~Total dose(summation dose with 3D-CRT) (Gy10) (EQD2, α/β=10 Gy) = 5 x 진단 당시의 LN short diameter (cm) + 56 (pilot study range, 54.6-78.0 Gy)"
16156431|NCT01730638|Drug|• TF2 and 68 Ga-IMP-288|
16156432|NCT01730625|Behavioral|Cognitive behavioral therapy for anxiety|
16156433|NCT01730625|Behavioral|Attention Bias Modification Treatment|
16156434|NCT01730612|Drug|TF2 - 68 Ga-IMP-288:|ImmunoTEP
16156435|NCT01730599|Other|neurological exam|motor and cognitive functions
16156436|NCT01730586|Drug|Abraxane|220 mg/m2 administered by vein on Day 1. A cycle of therapy is defined as 21 days.
16156437|NCT01730573|Procedure|interscalene block|This arm patients will receive inter scalene block which will be ultrasound and nerve stimulator guided.
16156438|NCT01730573|Procedure|Suprascapular and Axillary nerve block|This arm patients will receive Suprascapular and axillary nerve blocks which will be ultrasound guided and nerve stimulator guided.
16156439|NCT01730560|Other|Treatment A|"The computer-based training task consists of a novel ramp-step search paradigm with a stimulus traversing the screen from left to right or right to left. Subjects are asked to pursue the stimulus (ramp phase) and then saccade to find its location when it suddenly jumps (step phase). The stimulus is an open spinning circle. At the end of each movement, the gap can be located at the top or at the bottom, and patients are asked to indicate this location by pushing the response button as quickly as possible.
~The starting point will alternate between left and right. The training task includes 3 sessions with 100 movements each. Reaction Times and errors will be monitored online to ensure that the patient performs the task correctly.
~Each treatment phase has the same pattern:
~two visits in pre-tests evaluation (V1 and V2),
~one visit to perform treatment (A or B) and to assess immediate and 2h post-effects (V3),
~two visits after treatment (V4 at one week and V5 at one month)."
16156440|NCT01730560|Other|Treatment B|"Placebo treatment using the same computer-based training task, but including only the ramp phase.
~Each treatment phase has the same pattern:
~two visits in pre-tests evaluation (V1 and V2),
~one visit to perform treatment (A or B) and to assess immediate and 2h post-effects (V3),
~two visits after treatment (V4 at one week and V5 at one month)."
16156441|NCT01730547|Biological|Autologous mesenchymal stem cells|
16156442|NCT01730534|Drug|Dapagliflozin 10 mg|Oral dose (od)
16156443|NCT01730534|Drug|Placebo tablet|Oral dose (od)
16156444|NCT01730521|Behavioral|Exercise (Running)|the study foresees a measurement of iron biavailability in a resting and in a exercising phase and subjects will act as their own control during the study.
16156445|NCT01730508|Drug|Pegylated Interferon Alfa (Peginterferon Alfa)|Peginterferon alfa dosing and treatment duration are at the discretion of the investigator in accordance with China clinical practice and local labeling.
16156446|NCT01730495|Drug|Etanercept|Weekly subcutaneous injections of Etanercept 50 mg, for up to 12 months.
16156447|NCT01730482|Drug|[14C] AT1001|150 mg of [14C] labelled AT1001 will be administered as a solution (prepared by weighing 150 mg of AT1001 powder and dissolving in 100 mL of water). The entire solution will be swallowed orally. After ingestion of study medication, the dosing bottle will be rinsed with 50 mL of water and this will be ingested by the subject. This rinse procedure should be performed twice. Following the second rinse ingestion, the subjects should be instructed to drink additional water to bring the total volume ingested to 240 mL.
16156448|NCT01730469|Drug|AT1001 150 mg|AT1001 150mg is available as a capsule
16156449|NCT01730456|Drug|tocilizumab [RoActemra/Actemra]|8 mg/kg iv every 4 weeks, up to 104 weeks
16161033|NCT01695902|Drug|Mirena|
16156450|NCT01730417|Drug|no carrier added metaiodobenzylguanidine|Sequential imaging was performed to determine radiation dosimetry of high specific activity 123I-mIBG
16156451|NCT01730404|Drug|CHF6001 DPI|
16156452|NCT01730404|Drug|Roflumilast|
16156453|NCT01730404|Drug|Placebo|
16156454|NCT01730391|Other|Data collection|Collection of demographic data and vaccination history
16156455|NCT01730391|Other|CSF samples testing|CSF samples will be tested for the determination of N. meningitidis and other likely bacterial pathogens that cause bacterial meningitis (S. pneumoniae and H. influenzae)
16156456|NCT01730378|Biological|Prepandrix™|2 doses administered intramuscularly in the deltoid region of arm (non-dominant arm at Day 0 and dominant arm at Day 21).
16156457|NCT01730378|Biological|Fluarix™|1 dose administered intramuscularly in the deltoid region of non-dominant arm.
16156458|NCT01730365|Procedure|Core biopsy procedure|Core biopsy of suspicious lesion in lung, liver, breast, or colorectal liver metastasis.
16156459|NCT01730352|Drug|H. pylori triple therapy|Children up to 5 years: clarithromycin 15mg/kg, amoxicillin 50mg/kg, and/or furazolidone 7mg/kg Children above 8 years: doxycycline 4,4mg/kg if necessary Children able to swallow tablets or capsules, above 30kg: clarithromycin 500mg, amoxicillin 500mg, furazolidone 200mg, and/ or doxycycline 100mg, all 2 times per day, for 14 days.
16156460|NCT01730339|Drug|PF-06473871|Single dose administered by injection four different times
16156461|NCT01730339|Drug|PF-06473871|Single dose administered by injection three different times
16156462|NCT01730326|Drug|Paracetamol|1000 mg
16156463|NCT01730326|Drug|Dexketoprofen|50 mg
16156464|NCT01730313|Drug|Pyridoxine|
16156465|NCT01730313|Drug|Sodium Valproate|
16156466|NCT01730313|Drug|Phenytoin|
16156467|NCT01730313|Drug|Placebo|
16156468|NCT01730287|Drug|Control|The teeth in this group restored only by filling material,without liner application.
16156469|NCT01730287|Drug|Calcium Hydroxide|Calcium Hydroxide paste applied.
16156470|NCT01730287|Drug|Mineral Trioxide Aggregate(MTA)|MTA applied .
16156471|NCT01730287|Drug|CEM cement|CEM cement applied .
16156472|NCT01730261|Behavioral|Online Emotional Regulation Treatment|Emotional Regulation Training (EmReg) is a cognitive-behavioral approach which aims to increase awareness, and self-monitoring of affective states to improve self-regulation. EmReg combines didactic and experiential training, and emphasizes skill acquisition and generalization through examination of incidents of emotional dysregulation in one's life and completion of homework assignments. The treatment is divided into two phases: knowledge provision and practice facilitation. During the knowledge provision phase participants are introduced to the objectives and the main concepts of the treatment, to increase their familiarity with the terminology, and to the emotional regulation skills they acquire during the practice facilitation phase. During the practice facilitation phase participants receive training in emotional regulation skills, which they practice in-session with the guidance of the therapist and feedback from the group, as well as out-of-session as homework assignments.
16156473|NCT01730248|Drug|INC424|5 mg tablets administered orally twice daily
16156474|NCT01730248|Drug|BKM120|10 mg and 50 mg hard gelatin capsules administered orally once daily
16156475|NCT01730235|Other|MyMediHealth access|Patients who will be given access to a web-based medication scheduling and SMS-based reminder system.
16156476|NCT01730222|Drug|cisplatin|cisplatin at 30 mg/m2 on days 1 and 15
16156477|NCT01730222|Drug|capecitabine|capecitabine at 1250 mg/ m2 days 1-28
16156478|NCT01730222|Drug|gemcitabine|gemcitabine at 800 mg/ m2 on days 1 and 15 in arm A; at 1000 mg/m2 on days 1, 8 and 15 in arm B
16156479|NCT01730222|Drug|nab-paclitaxel|nab-paclitaxel at the recommended phase II dose day 1 and 15 in arm A; at 125 mg/m2 on days 1, 8 and 15 in arm B
16156480|NCT01730209|Drug|Everolimus|Everolimus once daily titrated to trough levels of 5-10 ng/ml.
16156481|NCT01730209|Drug|Placebo|
16156482|NCT01730196|Behavioral|Fit Body and Soul|
16156483|NCT01730196|Behavioral|Wellness Education|
16156484|NCT01730183|Other|Bone marrow derived stem cells|Intrathecal administration of autologous bone marrow derived stem cells upto a cell dose of equal or greater than 10(8)BMMNCs.
16156485|NCT01730157|Biological|ipilimumab|Given IV
16156486|NCT01730157|Radiation|yttrium Y 90 glass microspheres|Given via hepatic arterial infusion
16156487|NCT01730157|Other|laboratory biomarker analysis|Correlative studies
16156488|NCT01730118|Biological|AdHER2/neu DC Vaccine|autologous AdHER2 transduced dendritic cell vaccine manufactured under GMP conditions from cryopreserved patient monocytes here at the NIH CC DTM. Vaccine is administered intradermally at assigned dose level at weeks 0, 4, 8, 16 and 24 of the study.
16156489|NCT01730066|Dietary Supplement|L. plantarum 299 and L. plantarum 299v (+maltodextrin)|"Patients will be given a mixture of maltodextrin ( a starch product often used i alimentary products) and two strains of probiotic bacteria ( L. plantarum 299 and L. plantarum 299v ) dissolved in water. They will gurgle and swallow the suspension from the day before surgery. Postoperatively they will be given the probiotic mixture via a nasogastric tubing twice a day and when the responsible surgeon find it suitable also orally as described above. When they can swallow no study product is given through the nasogastric tube.
~Patients randomized 1:1 between groups"
16156490|NCT01730053|Drug|Alirocumab|Alirocumab administered as a SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.
16156491|NCT01730053|Drug|Rosuvastatin|Rosuvastatin over-encapsulated tablets orally.
16156492|NCT01730053|Drug|Ezetimibe|Ezetimibe over-encapsulated tablets orally.
16156493|NCT01730053|Drug|Placebo|Placebo for alirocumab and ezetimibe.
16156494|NCT01730040|Drug|Alirocumab|Alirocumab administered as a SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.
16156495|NCT01730040|Drug|Atorvastatin|Atorvastatin over-encapsulated tablets orally.
16156496|NCT01730040|Drug|Ezetimibe|Ezetimibe over-encapsulated tablet orally.
16156497|NCT01730040|Drug|Rosuvastatin|Rosuvastatin over-encapsulated tablets orally.
16156498|NCT01730040|Drug|Placebo|Placebo for alirocumab and ezetimibe.
16156499|NCT01730027|Drug|ADC3680|ADC3680 for 12 weeks plus montelukast for the last 2 weeks of the dosing period
16156500|NCT01730027|Drug|Placebo|Placebo for 12 weeks plus montelukast for the last 2 weeks of the dosing period
16156502|NCT01730014|Drug|148-0287-A-4.2mM-cartridge|In a dose-escalating design, healthy subjects will receive a single dose, injected subcutaneously.
16156503|NCT01730014|Drug|placebo|In a dose-escalating design, healthy subjects will receive 148-0287-A-placebo-cartridge, injected subcutaneously.
16156504|NCT01730014|Drug|148-0287-A-4.2mM-cartridge|In a dose-escalating design, subjects with type 1 diabetes will receive a single dose, injected subcutaneously. Subjects will only be randomised to receive either treatment A or B.
16156505|NCT01730014|Drug|placebo|In a dose-escalating design, subjects with type 1 diabetes will receive 148-0287-A-placebo-cartridge in a single dose, injected subcutaneously. Subjects will only be randomised to receive either treatment A or B.
16156506|NCT01730014|Drug|insulin glargine|In a dose-escalating design, subjects with type 1 diabetes will receive insulin glargine once daily, injected subcutaneously. Subjects will only be randomised to receive either treatment A or B.
16156507|NCT01730014|Drug|sodium chloride 0.9% w/v|In a dose-escalating design, subjects with type 1 diabetes will receive sodium chloride 0.9% w/v, injected subcutaneously daily. Subjects will only be randomised to receive either treatment A or B.
16156508|NCT01730001|Procedure|Early Intubation|
16156509|NCT01730001|Procedure|Late intubation|
16156510|NCT01729988|Procedure|Carotid body excision|"This surgery does not involve any study drug or investigational device.
~The carotid body will be removed by the so called 'lateral approach' or a combined 'lateral and medial approach'. In all cases the target area was defined as the tissue in between the ECA and ICA, up to 5-6mm above the bifurcation point of the common carotid artery into the ECA and ICA. In a lateral approach the carotid bifurcation is not turned. A combined approach includes usually dissection of the superior thyroid vessel and turning of the carotid bifurcation."
16156511|NCT01729949|Dietary Supplement|Active Treatment Beverage|Strawberry and Blackcurrent extract
16156512|NCT01729949|Dietary Supplement|Placebo Treatment Beverage|without active components
16156513|NCT01729936|Behavioral|Sitting time Change Intervention|Intervention to find alternatives to substitute sitting time by doing the regular activities standing or walking.
16156514|NCT01729923|Drug|Capecitabine|Given PO
16156515|NCT01729923|Drug|Celecoxib|Given PO
16156516|NCT01729923|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16156517|NCT01729923|Other|Laboratory Biomarker Analysis|Correlative studies
16156518|NCT01729923|Other|Quality-of-Life Assessment|Ancillary studies
16156519|NCT01729923|Radiation|Radiation Therapy|Undergo radiation therapy
16156520|NCT01729923|Radiation|Stereotactic Radiosurgery|Undergo stereotactic radiosurgery
16156521|NCT01729923|Procedure|Therapeutic Conventional Surgery|Undergo surgical resection
16156522|NCT01729910|Behavioral|Parent education / behavioral counseling|Providers and study personnel will be trained in the use of the NIH We Can! curriculum for group visits and brief motivational interviewing for individual visits and follow-up phone calls. Training will be conducted by the PI and Co-Investigators using a combination of online, self-study, and face-to-face formats totally at least/approximately 8 hours. At least one project team member will attend each group visit. Specifically, the American Academy of Pediatrics 15-minute Obesity Prevention Protocol will be utilized during individual visits. The intervention is designed to take place over a period of 10-12 weeks in the primary care office.
16156523|NCT01729910|Behavioral|Usual Care|Parents of children in the control group will receive usual care from their primary care provider as well as a copy of the NIH We Can! Parent Handbook.
16156524|NCT01729897|Drug|Etomidate|
16156525|NCT01729897|Drug|Fentanyl|
16156526|NCT01729897|Drug|Propofol|
16156527|NCT01729884|Biological|HER-2/neu peptide vaccine|Given ID
16156528|NCT01729871|Drug|rivaroxaban|rivaroxaban 20 mg orally, once-daily, administered preferably with the evening meal
16156529|NCT01729871|Drug|uninterrupted vitamin K antagonist (VKA)|dose-adjusted vitamin K antagonist (VKA) to achieve a recommended International Normalized Ratio (INR) of 2.0 to 3.0
16156530|NCT01729858|Device|Ceramic-Ceramic|"Zirconia computer aided design and computer milled cores with press on veneers with different thicknesses, gingival embrasure diameters and connector heights.
~Fifty percent of the recruited subjects will be given a ceramic-ceramic bridge at baseline."
16156531|NCT01729858|Device|Metal-Ceramic|"Metal Ceramic prosthesis with press on veneer with different thicknesses, different diameters of curvature of gingival embrasure and connector heights.
~Fifty percent of the recruited subjects will receive the metal-ceramic bridges at baseline."
16156532|NCT01729845|Drug|Cytarabine|Given IV
16156533|NCT01729845|Drug|Decitabine|Given IV
16156534|NCT01729845|Drug|Etoposide|Given IV
16156535|NCT01729845|Other|Laboratory Biomarker Analysis|Correlative studies
16156536|NCT01729845|Drug|Mitoxantrone Hydrochloride|Given IV
16156537|NCT01729832|Procedure|breast reconstruction|Undergo DIEP flap breast reconstruction using the StealthStation navigation system
16156538|NCT01729832|Procedure|intraoperative imaging|Undergo DIEP flap breast reconstruction using the StealthStation navigation system
16156539|NCT01729819|Drug|Tolterodine tartrate extended release capsules|
16156540|NCT01729819|Drug|Desmopressin orally disintegrating tablets|
16156541|NCT01729819|Drug|Placebo orally disintegrating tablets|
16156542|NCT01729806|Biological|Ipilimumab|Given IV
16156543|NCT01729806|Other|Laboratory Biomarker Analysis|Correlative studies
16156544|NCT01729806|Biological|Rituximab|Given IV
16156545|NCT01729793|Dietary Supplement|Digestive Enzyme #2|Contains dietary supplement proteases, lipases and carbohydrases
16156546|NCT01729793|Other|Placebo|Capsule containing microcrystalline cellulose
16156547|NCT01729780|Device|EEG-NF|
16156548|NCT01729767|Drug|Acyclovir|Patients who were randomly allocated to the Acyclovir group besides sticking with low salt diet will take the Acyclovir 400 mg pills for 10 days 5 times a day, then 3 times a day for next 10 days, and 2 times a day for the last 10 days. Patients would receive the medication in 2 sessions, first in the beginning of the study and the rest after 10 days. This way it would boost their compliance, and physicians would be aware of possible complications. Patients will report changes in their symptoms 10 days after initiating the drug and in 1, 3, and 6 month intervals. All changes in frequency and duration of vertigo attacks are recorded, and their tinnitus and aural fullness is recorded in a 0(with no symptom) to 4 (very severe) scale.
16162032|NCT01687777|Biological|OrthADAPT|
16156549|NCT01729767|Drug|Placebo|Participants who are randomly placed in placebo group, besides sticking with low salt diet will take the placebo (inert ingredient) for 10 days 5 times a day, then 3 times a day for next 10 days, and 2 times a day for the last 10 days. Patients would receive the medication in 2 sessions, first in the beginning of the study and the rest after 10 days. This way it would boost their compliance, and physicians would be aware of possible complications. Patients will report changes in their symptoms 10 days after initiating the drug and in 1, 3, and 6 month intervals. All changes in frequency and duration of vertigo attacks are recorded, and tinnitus and aural fullness is recorded in a 0(with no symptom) to 4 (very severe) scale.
16156550|NCT01729754|Drug|Tildrakizumab 200 mg|Tildrakizumab 200 mg administered SC. Each pre-filled syringe (PFS) or autoinjector (AI) contains 1 mL of solution, tildrakizumab 100 mg/mL.
16156551|NCT01729754|Drug|Tildrakizumab 100 mg|Tildrakizumab 100 mg administered SC. Each PFS or AI contains 1 mL of solution, tildrakizumab 100 mg/mL.
16156552|NCT01729754|Drug|Tildrakizumab Placebo|Matching placebo to tildrakizumab administered SC
16156553|NCT01729754|Drug|Etanercept Placebo|Matching placebo to etanercept administered SC
16156554|NCT01729754|Drug|Etanercept 50 mg|Etanercept 50 mg administered SC
16156555|NCT01729741|Procedure|drain was inserted after thyroid surgery|insertion of drain after thyroid surgery
16156556|NCT01729728|Drug|Tapentadol|Tapentadol oral solution single dose (1mg/kg body weight)
16156557|NCT01729715|Behavioral|Internet|
16156558|NCT01729715|Behavioral|DVD|
16156559|NCT01729702|Other|blood sample collection|
16156560|NCT01729689|Other|counseling intervention|Undergo cognitive behavioral therapy
16156561|NCT01729689|Other|questionnaire administration|Ancillary studies
16156562|NCT01729689|Procedure|quality-of-life assessment|Ancillary studies
16156563|NCT01729676|Drug|Degarelix or GnRH agonist|Degarelix or GnRH agonist for treatment of prostate cancer according to physicians current practice
16156564|NCT01729663|Biological|CSF470 vaccine, BCG, Molgramostim|
16156565|NCT01729663|Drug|interferon alpha 2b|
16156566|NCT01729650|Behavioral|Physical and diet educational group|educational group of: physical activity program (basically walking) of 24 sessions over 12 weeks, and diet (16 sessions in the first 8 weeks, carried out by mental health nurses.
16156567|NCT01729598|Drug|Valproic Acid|generic valproic acid tablets packaged in placebo-matched capsules.
16156568|NCT01729598|Drug|Placebo|Placebo capsule without active study medication in identical capsules as experimental medicine.
16156569|NCT01729585|Procedure|Massage Therapy|The Massage Therapy protocol consists of a series of 5 massages administered over 10 (+2) weeks. Length of time for each visit will be approximately 1.5 - 2 hours Typically, a series of treatments over time allows the body time to integrate tissue related changes and potentially maintain a more healthy musculoskeletal state. Based on expert opinion in the field of MT, following a series of massage treatments administered over time, one can anticipate tissue changes. By adding time between treatments, data will describe the ability of subjects to maintain changes over progressively longer periods of time. Treatment protocol will be based on the application of myofascial trigger point therapy (Timberlake, 1999) to musculoskeletal areas of the body often affected by disease progression in CF.
16156570|NCT01729572|Other|Tele-medicine monitoring of medication adherence|
16156571|NCT01729559|Drug|5000 Units unfractionated Heparin Q 8 hr|Venous thromboembolic prophylaxis medication
16156572|NCT01729559|Drug|30mg enoxaparin Q12 hr|Venous thromboembolic prophylaxis
16156573|NCT01729546|Device|7 Blood glucose monitoring systems|
16156574|NCT01729533|Other|ICSI|ICSI Sperm selection in the ICSI group is analyzed under a magnification of 400x using an inverted microscope. ICSI is performed in a micro-injection dish prepared with 4 µL droplets of buffered medium and covered with paraffin oil on a heated stage at 37.0 ± 0.5°C of an inverted microscope.
16156575|NCT01729533|Other|IMSI|Sperm selection in the IMSI group is analyzed at high magnification using an inverted microscope equipped with high-power differential interference contrast optics. The total calculated magnification is x6.600. The sperm cells exhibiting normally shaped nuclei ([1] smooth, [2] symmetric, and [3] oval configuration) and [4] normal nuclear chromatin content (if it contained no more than one vacuole, which occupies <4% of the nuclear area) are selected for injection.
16156576|NCT01729520|Other|Knee extension strength training|"Load experiment: Four knee extensions will be performed with the operated leg at 20, 14, and 8 RM loadings each, in a randomized order. Range of knee joint motion and time under tension for each repetition will be controlled for
~Failure experiment: One strength training set of knee extensions will be performed with the operated leg at 10 RM loading until contraction failure. Range of knee joint motion and time under tension for each repetition will be controlled for"
16156577|NCT01729507|Other|tDCS|Stimulation will be performed with a DC stimulator MC Location of stimulation: Anode over the left dorsolateral cortex, corresponding with F3 (in 10-20 EEG system); cathode over the right temporal cortex Intensity: 2 mA Total duration: Constant stimulation for 20 minutes
16156578|NCT01729507|Behavioral|standardised behavioural therapy|"The standardised behavioural therapy will be performed according to the certified Smoke-free programme' of the of the Institute for Therapy Research ('Institut für Therapieforschung', IFT). The course leaders' manual specifies that the ideal number of participants is 8-12.
~1 group session for 90 minutes/week for 7 weeks, 2 telephone calls of 10 minutes each, first after the fourth session 3 days after collective smoking cessation, second on day 3 after the last session."
16156579|NCT01729494|Drug|Alemtuzumab|Alemtuzumab will be dosed on day of transplant (Study Day 1) at dose of 30 mg given intravenously (IV) over a period of 2 hours after induction of anesthesia. Methylprednisolone IV will be administered 30-60 minutes prior to the administration of alemtuzumab.
16156580|NCT01729494|Drug|rabbit antithymocyte globulin|Rabbit antithymocyte globulin will be dosed post-operatively at a total cumulative dose of 4.0-6.0mg/kg given by days 5-10 post-transplant. It will be administered by local standards of care with the following recommendations. The initial intravenous intra-operative dose will be administered approximately one hour after the methylprednisolone dose. The first dose will be administered so that approximately 25% of the dose is infused prior to revascularization of the graft. Subsequent doses will be administered over a minimum of 4 hours. Premedication with acetaminophen 650mg p.o. and diphenhydramine 25mg p.o. prior to rabbit antithymocyte globulin dose will be given to reduce the incidence of infusion reactions.
16156925|NCT01726751|Device|Spinal cord nerve stimulation|
16156581|NCT01729494|Drug|Belatacept|Belatacept will be administered via intravenous (IV) infusion according to the FDA approved dosage recommendations. Subjects randomized to belatacept arms will receive the first dose of IV belatacept (10 mg/kg) within 12-24 hours post reperfusion. The second dose will be given between post-transplant days 4 -6 (Study Days 5-7), and then study days 14, 28, 56, and 84 (12 weeks) and then subjects will receive belatacept at the maintenance dose of 5 mg/kg every 4 weeks until completion of the trial at 24 months (104 weeks). Study Day 1 is defined as the day of transplant.
16156582|NCT01729494|Drug|Tacrolimus|Tacrolimus will be administered orally twice daily (BID). The recommended total initial dose of tacrolimus is 0.1 mg/kg/day in two divided doses orally. Tacrolimus should be started post-transplant within 48 hours or when serum creatinine drops lower than 4mg/dL, whichever comes first. The initial targeted trough level of tacrolimus will be 8 - 12 ng/mL for Days 1 through 30, with dose reduction to achieve a 12-hour trough target of 5 - 10 ng/mL thereafter.
16156583|NCT01729494|Drug|Mycophenolate mofetil|The first dose of mycophenolate mofetil/EC mycophenolate sodium will be administered pre-operatively. Patients receiving mycophenolate mofetil will be dosed 1000 mg twice daily (2000mg/day). Patients receiving EC mycophenolate sodium will be dosed 720 mg twice daily (1440 mg/day). Dose may be increased for African American transplant recipients to mycophenolate mofetil 1500 mg twice daily (3000mg/day) or EC mycophenolate sodium 1080 mg twice daily (2160 mg/day).
16156584|NCT01729494|Drug|early cessation of steroids|"Glucocorticoid therapy will be administered as described. Methylprednisolone will be administered on Days 1 through 3. Additional tapering doses of glucocorticoids will continue to be given until Day 5 as below:
~Day 1 (day of transplant): 500mg IV prior to alemtuzumab (Group A) or rabbit antithymocyte globulin (Groups B and C) Day 2: 250mg IV Day 3: 125mg IV Day 4: 80mg p.o. Day 5: 60mg p.o. No further steroids"
16156585|NCT01729481|Drug|Gemcitabine|1000 mg/m² iv weekly
16156586|NCT01729481|Drug|Erlotinib|100mg, once per day
16156587|NCT01729481|Drug|Oxaliplatin|85mg/m², q2weeks
16156588|NCT01729481|Drug|Folinic Acid|400 mg/m², q2weeks
16156589|NCT01729481|Drug|Irinotecan|180 mg/m², q2weeks
16156590|NCT01729481|Drug|5-FU|400 mg/m² Day 1; 2400 mg/m² 46 hour invusion, q2weeks
16156591|NCT01729468|Drug|Aspirin|Aspirin, 160 mg per day until 34 weeks of gestation
16156592|NCT01729468|Drug|Placebo|Placebo, 160 mg per day until 34 weeks of gestation
16156593|NCT01729455|Biological|BENLYSTA|"As prescribed.
~Belimumab is a recombinant, human, IgG1λ monoclonal antibody for the treatment of systemic lupus erythematosus."
16156594|NCT01729455|Other|SLE treatment|"As prescribed.
~At baseline, SLE treatment must include an immunosuppressant. During the registry, SLE treatment may include any of the following (alone or in combination): immunosuppressants, corticosteroids, antimalarials, other biologics, investigational agents for SLE, as clinically indicated."
16156595|NCT01729442|Other|Shear-wave ultrasound elastography (SWUE)|
16156596|NCT01729429|Behavioral|HPV brochure, recall, reminders|"HPV-vaccine specific brochure mailed before clinic visit
~Telephone recalls after visit for those who complete pre-clinic survey and decline the vaccine
~Telephone reminders for those who complete the pre-clinic survey and are late for receiving the 2nd and/or 3 doses"
16156597|NCT01729429|Behavioral|General Adolescent Vaccine Brochure|Participants were mailed a brochure describing the 4 recommended adolescent vaccines (HPV, meningococcal, tetanus diptheria acellular pertussis (TDAP), and influenza) 1-2 weeks before a clinic visit
16156598|NCT01729416|Other|Water Exchange Colonoscopy|"We will turn off the air pump. The colonoscope will be inserted into the rectum and gently advanced. We will suction air pockets as scope is advanced towards the cecum. Water will be infused when encountering closed up lumen. All the infused water will be suctioned out. We will use all other techniques used with conventional air method as needed. For example abdominal pressure, shortening of scope to reduce looping, change of patient position etc.
~We will turn on air pump once cecum reached, or if unsuccessful with water method to open up a close lumen or to go past a tight turn.
~On withdrawal we will continue air insufflation as needed, and closely examine for polyps and remove all visualized polyps. If there is any residual fluid, it will be suctioned out as the scope is withdrawn."
16156599|NCT01729416|Other|Air Colonoscopy|Air will be infused into the colon during colonoscopy.
16156600|NCT01729403|Drug|aleglitazar|150 mcg orally daily, 16 weeks
16156601|NCT01729403|Drug|metformin|patients will continue on their existing dose and regimen of metformin (but not more than the maximum dose specified in the label)
16156602|NCT01729403|Drug|placebo|orally daily, 16 weeks
16156603|NCT01729390|Other|Energy density and portion size feeding study|In a crossover design, adults are served breakfast and lunch, 1 day a week for 6 weeks. Breakfast is not varied across weeks. At 4 of the lunch meals, a salad first course will be served that needs to be eaten in its entirety. At these 4 meals the lunch entree will vary in energy density (100% and 133%) and portion size (100% and 133%). At the 2 lunch meals for which no first course is served, the lunch entree will be vary in energy density (100% and 133%) but be the same portion size (133%).
16156604|NCT01729377|Other|Interview|
16156605|NCT01729364|Drug|crystalloid|
16156606|NCT01729364|Drug|colloid|
16156607|NCT01729338|Drug|Velcade|Bortezomib induction: 1.3 mg/m2, given subcutaneously (SC) on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Bortezomib maintenance (even cycles [10,12,14, etc.]: 1.3 mg/m2, given SC on days 1 and 15. For patients who required VELCADE dose reductions during induction, the last administered mg/m2 dose of VELCADE will be the starting dose for maintenance, given on days 1 and 15. Maintenance cycles will last 28 days and continue indefinitely, until disease progression, lack of tolerability, or death. Patients who cannot tolerate SC VELCADE will be converted to the same dose, given intravenously (IV), per discretion of the treating physician.
16156608|NCT01729338|Drug|Cyclophosphamide|Cyclophosphamide: 300 mg/m2, given orally on days 1,8 and 15. Up to eight cycles lasting 28 days each will be administered. Patients will not receive any study drugs during the final week of each induction cycle. Patients who cannot swallow cyclophosphamide pills will be converted to the same dose, given intravenously (IV).
16156645|NCT01729039|Behavioral|Control|The placebo exercises will consist of saccadic eye movements while the head is stationary and will be performed by the control group. These eye movements will be performed against a plain background in order to eliminate retinal slip and, therefore, eliminate the error signal for vestibular adaptation.
16162344|NCT01685255|Drug|Epacadostat|
16156609|NCT01729338|Drug|Revlimid|"Lenalidomide (odd cycles [9,11,13, etc.]: 10 mg, given orally on days 1-21. Maintenance cycles will last 28 days and continue indefinitely, until disease progression, lack of tolerability, or death. On even cycles, patients will be prescribed enough lenalidomide to take at home, as instructed, for one cycle. This will be prescribed through the mandatory RevlimidREMS® program. If a dose of lenalidomide is missed, it should be taken as soon as possible on the same day. If it is missed for the entire day, it should not be made up.
~Patients who take more than the prescribed dose of lenalidomide should be instructed to seek emergency medical care if needed and contact study staff immediately."
16156610|NCT01729325|Behavioral|Preventive Narrative Exposure Therapy|During Pre-NET the client, with the assistance of the therapist, constructs a chronological narrative of his whole life with a focus on exposure to traumatic stress. Empathic understanding, active listening, congruency and unconditional positive regard are key components of the therapist's behavior who asks in detail for emotions, cognitions, sensory information, and physiological reactions, linking them to an autobiographical context. During two sessions a chronological overview of the whole life with a focus on traumatic events is developed and the most important traumatic experiences are processed.
16156611|NCT01729299|Drug|Exendin (9-39)|
16156612|NCT01729299|Drug|acyl ghrelin|
16156613|NCT01729299|Drug|saline|
16156614|NCT01729286|Device|PriMatrix Moist Wound Therapy|sharp debridement, PriMatrix, a dressing regimen that maintains a moist wound healing environment, and offloading
16156615|NCT01729286|Other|Standard of Care Moist Wound Therapy|sharp debridement, a dressing regimen that maintains a moist wound healing environment, and offloading
16156616|NCT01729273|Other|Diet and Exercise Intervention|Remote Dietary and Exercise Intervention Program
16156617|NCT01729260|Drug|Mebendazole|The mebendazole will be given by mouth three times every day on a 28 day cycle. it's in the form of 500 mg chewable tablets, to be taken with meals.
16156618|NCT01729247|Device|NIOX MINO® Instrument (09-1100)|
16156619|NCT01729234|Dietary Supplement|Nitrate|Dietary Supplement
16156620|NCT01729234|Dietary Supplement|Placebo|Dietary Supplement
16156621|NCT01729208|Device|Dual Focus Soft Contact Lens|
16156622|NCT01729208|Device|Single Vision Soft Contact Lens|
16156623|NCT01729195|Procedure|A ciprofloxacin containing bioabsorbable PLGA bone screw|The syndesmosis injury will be fixed the antibiotic releasing bioabsorbable bone screw or a standard metal screw. After surgery, the ankle will be immobilized in a cast for 6 weeks. The metal screw will be surgically removed at 8 weeks. The bioabsorbable screw will be left in place.
16156624|NCT01729156|Drug|Metformin|1000 mg metformin twice daily in 3 months
16156625|NCT01729156|Drug|Placebo|2 tablets twice daily in 3 months
16156626|NCT01729143|Other|24-hour energy expenditure and substrate utilization|Subjects spent two x 24-hour periods inside the metabolic chamber at the UNC NRI (black pepper and no pepper control) each separated by one week. Subjects were requested to arrive at the study center each morning in a fasted state (at least 10 hours). During each study day, subjects remained sedentary. All meals were provided and were tailored to each subject's specific energy requirements. Study meals (with the exception of the 1.5g of black pepper) were identical between the black pepper and no pepper control study days.
16156627|NCT01729130|Procedure|Adipose tissue biopsy|Adipose tissue biopsy is done at time of transplant surgery. There is a second needle biopsy done between 3-12 months post transplant surgery.
16156628|NCT01729117|Other|Meal Replacement|5 Meal Replacements/day will be given for 3 months and then 1/day for 9 months.
16156629|NCT01729117|Other|Standard Care|Standard Care only
16156630|NCT01729104|Drug|Carfilzomib|"Phase I Starting Dose: 20 mg/m2 by vein on Days 1, 2, 8, 9, 15, and 16 of Cycles 1-12. Cycles 13 and beyond, dose given on Days 1, 2, 15, and 16.
~Phase II Starting Dose: MTD from Phase I."
16156631|NCT01729104|Drug|Lenalidomide|Phase I and Phase II: 20 mg by vein on Days 1-21 of each cycle.
16156632|NCT01729104|Drug|Rituximab|Phase I and II: 375 mg/m2 by vein on Days 1, 8, 15, and 22 of Cycle 1 and 2. For Cycles 3 - 12, given on Day 1. For Cycles 13 and beyond, given on Day 1 every other cycle for up to 24 months.
16156633|NCT01729091|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo autologous stem cell transplant
16156634|NCT01729091|Biological|Elotuzumab|Given IV
16156635|NCT01729091|Other|Laboratory Biomarker Analysis|Correlative studies
16156636|NCT01729091|Drug|Lenalidomide|Given PO
16156637|NCT01729091|Drug|Melphalan|Given IV
16156638|NCT01729091|Biological|Natural Killer Cell Therapy|Given IV
16156639|NCT01729091|Biological|Umbilical Cord Blood-Derived Lymphocyte Therapy|Given IV
16156640|NCT01729078|Dietary Supplement|Dietary intervention|three different diets ( high fat-low carb-low fiber/high carb-low fat - high fiber/high carb-low fat-low fiber)
16156641|NCT01729065|Other|Physical therapy intervention|Exercises addressing cervical range of motion, shoulder range of motion and strengthening and scapular stabilization.
16156642|NCT01729052|Device|Acupuncture|
16156643|NCT01729039|Behavioral|standard balance rehabilitation|All subjects perform balance and gait exercises in addition to eye exercises and receive a written home exercise program (HEP) of balance and gait exercises to improve postural stability and mobility with progressively challenging tasks. Balance exercises include maintaining stability with vision and somatosensory cues altered, dynamic weight shifts and performing ankle, hip and step strategies. Gait activities include negotiating uneven terrains and obstacles, gait with head turns, varied speed, and unpredictable starts and stops. Walking for endurance is included in the HEP. Each participant receives a customized balance and gait HEP based on identified impairments and is progressed according to ability and level of assistance at home.
16156644|NCT01729039|Behavioral|gaze stability|Vestibular adaptation and substitution exercises will be performed by the experimental group (GS). Adaptation exercises involve head movement while maintaining focus on a target, which may be stationary or moving. Typical progression of adaptation exercises involve increased velocity of head movement, movement of both target and head, target placed in a distracting visual pattern and maintenance of a challenging posture. During active eye-head exercise, a large eye movement to a target is made prior to the head moving to face the target, potentially facilitating use of preprogrammed eye movements.
16156753|NCT01728259|Drug|dexamethasone|Given PO
16156754|NCT01728259|Other|Laboratory Biomarker Analysis|Correlative studies
16157317|NCT01723800|Procedure|quality-of-life assessment|Ancillary studies
16156646|NCT01729026|Other|Shelter Dog Adoption|Veterans will choose a dog from the San Antonio Humane Society with the help a Humane Society adoption counselor and study staff and take it home to live with them. The dog will be a pet and not a service dog. Following adoption, Veterans and their dogs will receive eight weeks of free obedience training provided by a veterinarian.
16156647|NCT01729000|Other|Gloves|All staff must wear gloves for subjects that are in the experimental group.
16156648|NCT01728987|Drug|cholecalciferol|as in arm description
16156649|NCT01728987|Drug|placebo|capsule looking identical to the cholecalciferol capsule
16156650|NCT01728974|Other|Pharyngeal topical anesthesia|Pharyngeal topical anesthesia will be performed using 4% lidocaine spray
16156651|NCT01728961|Drug|Artemether/Lumefantrine (AL)|
16156652|NCT01728948|Drug|Sorafenib (Nexavar, BAY43-9006)|treatment (including dose, duration, modification) decided by the investigator
16156653|NCT01728935|Drug|Tenofovir disoproxil|Tenofovir disoproxil 300mg daily
16156654|NCT01728922|Dietary Supplement|5000IU vitamin D|Vigantol Oil
16156655|NCT01728922|Dietary Supplement|10000IU vitamin D|Vigantol Oil
16156656|NCT01728922|Other|Placebo|Placebo Oil
16156657|NCT01728909|Drug|Oxytocin|40 IU of the oxytocin will be administered intranasally for a one time dose at the beginning of the visit.
16156658|NCT01728909|Drug|Saline Nasal Spray|40 IU of the saline nasal spray will be administered once at the beginning of the visit.
16156659|NCT01728896|Other|Patient-controlled oral refeeding|
16156660|NCT01728883|Device|Home vision monitoring using myVisionTrack®|Patients will be asked to test their vision at home twice per week using myVisionTrack® during the study period.
16156661|NCT01728870|Other|Unique Diet+Partial Enteral Nutrition|Modulen - liquid dietary formula
16156662|NCT01728870|Other|Exclusive Enteral Nutrition (Modulen)|
16156663|NCT01728857|Device|The Zeltiq System|Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
16156664|NCT01728844|Device|beta-tricalcium phosphate alone|
16156665|NCT01728844|Device|GFeBGS 0.1%|
16156666|NCT01728844|Device|GFeBGS 0.3%|
16156667|NCT01728844|Device|GFeBGS 0.4%|
16156668|NCT01728818|Drug|Gemcitabine|1000 mg/m² d1,8,15 q4weeks
16156669|NCT01728818|Drug|Afatinib|40mg flat dose, po, once daily
16156670|NCT01728818|Drug|Gemcitabine|1000 mg/m², d1,8,15 q4weeks
16156671|NCT01728805|Biological|KW-0761|1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression
16156672|NCT01728805|Drug|Vorinostat|
16156673|NCT01728792|Biological|TDV|TDV IM or SC injection
16156674|NCT01728779|Drug|Nelfinavir|Commercially available nelfinavir (1250 mg) will be administered orally twice daily for 14 days.
16156675|NCT01728779|Radiation|Stereotactic Body Radiation (SBRT)|15 Gy dose (per lesion site) of SBRT will be administered
16156676|NCT01728766|Other|Small for gestational age at delivery|Small for gestational age at delivery. gestational age at >37 weeks by and birth weight <2500 g
16156677|NCT01728766|Other|Post-term Infant, Not Heavy-for-dates|Appropriate for gestational age at delivery. Gestational age at >37 weeks and birth weight >2800 g
16156678|NCT01728753|Drug|Placebo|Placebo BID x 1 day, and Placebo BID x 4 days; Placebo TID x 1 day, and Placebo TID x 4 days
16156679|NCT01728753|Drug|Favipiravir|1200 mg TID on Day 1, then 600 mg TID on Days 2-5
16156680|NCT01728753|Drug|Favipiravir|2400 mg loading dose followed by 600 mg + 600 mg on Day 1, then 600 mg TID on Days 2-5
16156681|NCT01728753|Drug|Favipiravir|1800 mg BID on Day 1, then 800mg BID for Days 2 5
16156682|NCT01728740|Drug|Acarbose/Metformin FDC (BAY81-9783)|Acarbose/Metformin FDC (BAY81-9783)50mg/500mg, oral, single dose
16156683|NCT01728740|Drug|Acarbose (Glucobay, BAYG5421)|Acarbose (Glucobay, BAYG5421) 50mg, oral, single dose
16156684|NCT01728740|Drug|Metformin|Metformin 500mg, oral, single dose
16156685|NCT01728727|Other|UC-MSC transplantation|After enrolled, Participant will receive umbilical cord MSC transplantation of 1*10E6 cells/kg via hepatic artery. Participant will then be followed until 1 years study visit
16156686|NCT01728727|Other|conventional treatment|Participants will receive conventional treatment and antiviral treatment.
16156687|NCT01728701|Biological|PfSPZ Challenge|PfSPZ Challenge is a suspension of aseptic, purified, cryopreserved PfSPZ that are thawed and formulated in diluent on the day of administration.
16156688|NCT01728701|Biological|Normal Saline (NS)|Normal saline
16156689|NCT01728688|Other|PBSC transplantation|PBSCs were mobilized with recombinant human G-CSF at 5-10ug/kg/d for three days. then PBSCs were collected by means of apheresis. The collected PBSCs were infused into participant via hepatic artery
16156690|NCT01728688|Other|conventional treatment|Participants will receive conventional treatment and antiviral treatment.
16156691|NCT01728675|Other|Exercise|Participants will perform two isokinetic eccentric exercise bouts
16156692|NCT01728662|Procedure|ELVR Procedure|Lung Volume Reduction Procedure
16156693|NCT01728649|Other|Mild Hypothermia|Hypothermia will be achieved using the Zoll Thermoguard XP technology with the Quattro catheter. This catheter has a 9.3 Fr diameter and is 4 3cm long. It will be placed in the patients femoral vein via Seldinger technique, before reperfusion is achieved. Hypothermia will be initiated prior to reperfusion. Once temperature has reached 33.5 degrees centigrade the patient will remain at that temperature for 12 hours after which the patient will undergo active gradual rewarming at 0.2 degrees centigrade per hour.
16156694|NCT01728636|Drug|Tranexamic Acid|intravenous administration of bolus and infusion for duration of surgical procedure
16156695|NCT01728623|Drug|E7080 capsule|E7080 is administered as continuous once daily dosing in an uncontrolled manner
16156696|NCT01728610|Dietary Supplement|Probiotic (Active high)|Higher dose of probiotic supplement
16156697|NCT01728610|Dietary Supplement|Probiotic (Active low)|Lower dose of probiotic supplement
16156698|NCT01728610|Dietary Supplement|Placebo|Placebo
16156755|NCT01728246|Drug|Tramadol/Paracetamol (APAP)|Celecoxib 200 milligram (mg) once daily for 4 weeks and fixed dose combination of Tramadol 37.5 mg/Paracetamol 325 mg thrice daily for 4 weeks as add-on therapy.
16156756|NCT01728246|Drug|Non-Tramadol/APAP|Celecoxib 200 mg alone once daily for 4 weeks.
16156924|NCT01726751|Device|Spinal Cord Stimultion (SCS)|Electric stimulation of the spinal cord
16156699|NCT01728584|Drug|Rocuronium|NMB will be induced by intravenous (IV) administration of a bolus dose of 0.45 mg/kg rocuronium. NMB will be maintained using rocuronium infusion or additional bolus doses as needed for the management of NMB to the targeted depth according to the assigned treatment condition. - Standard NMB - administration of neuromuscular blocking agent (NMBA) titrated to a depth of blockade at a targeted TOF ratio of 10% (range: TOF count 2-3 to TOF ratio of 20%). - Deep NMB - administration of NMBA titrated to a targeted depth of 1-2 Post Tetanic Counts (PTCs) (range: 1-5 PTC).
16156700|NCT01728584|Other|Insufflation|"Insufflation (injection) of carbon dioxide will be used to induce pneumoperitoneum, which is presence of air or gas in the abdominal (peritoneal) cavity.
~Standard insufflation pressure - a starting pressure of 12 mmHg will be used.
~Low insufflation pressure - a starting pressure of 8 mmHg will be used."
16156701|NCT01728584|Drug|Sugammadex|NMB will be reversed with IV administration of 2 or 4 mg/kg sugammadex (depending on the depth of NMB) according to the approved label for sugammadex.
16156702|NCT01728571|Dietary Supplement|Vitamin D3|
16156703|NCT01728571|Dietary Supplement|fish oil|
16156704|NCT01728571|Dietary Supplement|Vitamin D3 placebo|
16156705|NCT01728571|Dietary Supplement|Fish oil placebo|
16156706|NCT01728558|Other|Early goal Directed Sedation|
16156707|NCT01728558|Other|Standard care sedation|
16156708|NCT01728532|Device|Pulp Canal Sealer (Kerr)|permanent obturation of the root canal space with the aid of obturating points
16156709|NCT01728532|Device|PA0903|Sealing performed by the dentist , coronal obturation placed after the canal obturation
16156710|NCT01728519|Drug|AllerT SC|AllerT subcutaneous injections on days 1, 7, 14, 21 and 56 - cumulative dose 440 microgram)
16156711|NCT01728519|Drug|AllerT ID|AllerT intra-dermal injections on days 1, 7, 14, 21 and 56 - cumulative dose 440 microgram)
16156712|NCT01728519|Drug|Placebo SC|Placebo subcutaneous injections on days 1, 7, 14, 21 and 56
16156713|NCT01728519|Drug|Placebo ID|Placebo intra-dermal injections on days 1, 7, 14, 21 and 56
16156714|NCT01728506|Behavioral|Weight Loss and Exercise|Internet delivered, behaviorally based weight loss and exercise intervention
16156715|NCT01728480|Drug|entolimod|Given SC
16156716|NCT01728480|Radiation|intensity-modulated radiation therapy|Undergo IMRT
16156717|NCT01728480|Drug|cisplatin|Given IV
16156718|NCT01728480|Other|pharmacological study|Correlative studies
16156719|NCT01728480|Other|laboratory biomarker analysis|Correlative studies
16156720|NCT01728467|Drug|RVX000222|capsule, 200 mg, administer with food, 100 mg twice daily 10-12 hrs apart, 31-35 days
16156721|NCT01728467|Drug|Placebo, RVX000222|capsule, administer with food, twice daily 10-12 hrs apart, 31-35 days
16156722|NCT01728454|Drug|Placebo|Placebo matching capsules, orally, once daily for 18 weeks.
16156723|NCT01728454|Drug|Telapristone acetate|Telapristone acetate capsules, orally once daily for 18 weeks.
16156724|NCT01728441|Device|Paclitaxel Eluting Stent|
16156725|NCT01728441|Device|Paclitaxel Eluting Balloon|
16156726|NCT01728415|Other|exercise|Group A: high intensity exercise training Group B: moderate intensity exercise training C: Control group
16156727|NCT01728402|Procedure|blood draw, bone marrow procedure, or tissue biopsy|
16156728|NCT01728389|Procedure|Intrabone transplantation|Direct intrabone transplantation procedure of peripheral blood haematopoietic stem cells form HLA-matched sibling donors in patients with myeloid and lymphoid malignancies.
16156729|NCT01728376|Drug|Daptomycin|Intravenous daptomycin given at 7 mg/kg (ages 12-17 years); 9 mg/kg (ages 7-11 years); 12 mg/kg (ages 1-6 years) infused once daily, intravenously, over 30 or 60 minutes. Participants may be switched to oral therapy following completion of IV study drug administration provided they showed clear clinical improvement and the pathogen was susceptible to an oral agent.
16156730|NCT01728376|Drug|Comparator|Vancomycin, Semi-synthetic penicillin, First-generation cephalosporins, Clindamycin: administered per standard of care. Participants may be switched to oral therapy following completion of IV study drug administration provided they showed clear clinical improvement and the pathogen was susceptible to an oral agent.
16156731|NCT01728363|Drug|Antibiotic|Ticarcillin-clavulanate/Timentin is an antibiotic used to treat a wide variety of bacterial infections. Rifampin/Rifadin/Rimatane is an antibiotic and first line antituberculotic. Clindamycin/Cleocin is an antibiotic used to treat a wide variety of bacterial infections and serious bacterial infections.
16156732|NCT01728350|Behavioral|HOPE - Helping Others through Purpose and Engagement|
16156733|NCT01728337|Drug|Dysport|Dysport® was injected on the right side of the forehead and Xeomin® was injected on the left side of the forehead.
16156734|NCT01728337|Drug|Xeomin|Xeomin® was injected on the right side of the forehead and Dysport® was injected on the left side of the forehead
16156735|NCT01728324|Drug|BI 207127-placebo: 8-week treatment|8 weeks of placebo treatment
16156736|NCT01728324|Drug|Ribavirin: 24-week treatment|24 weeks of active treatment
16156737|NCT01728324|Drug|BI 207127: 24-week treatment|24 weeks of active treatment
16156738|NCT01728324|Drug|Faldaprevir: 24-week treatment|24 weeks of active treatment
16156739|NCT01728324|Drug|Faldaprevir: 24-week treatment|24 weeks of active treatment
16156740|NCT01728324|Drug|Ribavirin-placebo: 8-week treatment|8 weeks of placebo treatment
16156741|NCT01728324|Drug|BI 207127: 24-week treatment|24 weeks of active treatment
16156742|NCT01728324|Drug|Faldaprevir-placebo: 8-week treatment|8 weeks of placebo treatment
16156743|NCT01728324|Drug|Faldaprevir: 16-week treatment|16 weeks of active treatment
16156744|NCT01728324|Drug|Ribavirin: 16-week treatment|16 weeks of active treatment
16156745|NCT01728324|Drug|RBV: 24-week treatment|24 weeks of active treatment
16156746|NCT01728324|Drug|BI 207127: 16-week treatment|16 weeks of active treatment
16156747|NCT01728311|Drug|BAY1082439|BAY1082439 will be given orally once daily with a 21 days cycle. Dose will be started from 15mg.
16156748|NCT01728298|Biological|SLITone ULTRA HDM immunotherapy|
16156749|NCT01728285|Device|Electronic compliance device (Memozax®)|An electronic compliance device is distributed to patients allocated to the active arm
16156750|NCT01728272|Drug|blood concentration of metoprolol|measure blood concentration of metoprolol
16156751|NCT01728259|Drug|pomalidomide|Given PO
16156752|NCT01728259|Drug|bortezomib|Given IV
16156757|NCT01728233|Drug|Dacomitinib|PF-299804 will be administered orally at a dose of 45 mg/day continuously until surgery, evidence of disease progression or onset of unacceptable toxicity.
16156758|NCT01728220|Drug|Inhaled NO|
16156759|NCT01728220|Other|Placebo|Nitrogen gas
16156760|NCT01728207|Drug|IMMU-114|hL243 is a humanized antibody that targets HLA-DR, which is found on various b-cell hematologic malignancies and in autoimmune diseases.
16156761|NCT01728194|Drug|Escitalopram|20 mg target dose for 12 weeks
16156762|NCT01728194|Other|Magnetic Resonance Imaging|Structural and functional MRI of the brain for research purposes.
16156763|NCT01728181|Drug|Tivozanib|The phase I study will test two dose levels of tivozanib (dose level 1: 1.0 mg and dose level 2: 1.5 mg) given daily for 3 consecutive weeks followed by one week break. Based on the phase I results, the dose of tivozanib will be chosen for the phase II study.
16156764|NCT01728181|Drug|Erlotinib|150 mg/day for 28 day cycle. No rest period.
16156765|NCT01728181|Other|Standard of Care treatment|This treatment will be determined by the study doctor and is considered standard of care.
16156766|NCT01728155|Drug|chemotherapy|
16156767|NCT01728142|Device|DANA Brief|The DANA Brief is a newly-developed neurocognitive test administered on a handheld computer that tests simple reaction time, procedural reaction time, code substitution, and spatial processing. The test also includes subtests for depression/distress, PTSD, and insomnia.
16156768|NCT01728142|Other|ANAM|The ANAM is a currently used test by military health care providers in evaluating cognitive performance after concussion.
16156769|NCT01728129|Device|DANA Rapid|The DANA Rapid is a neurocognitive test self-administered on a small handheld computer. The DANA Rapid subtests measure simple reaction time, procedural reaction time, and reaction time sensitivity.
16156770|NCT01728129|Other|MACE|The MACE is currently the only standardized and Department of Defense-designated method for the initial evaluation of suspected concussion in military operational settings. The MACE documents the history of the injury-causing incident; assesses cognitive deficits in orientation, immediate memory, concentration, and delayed recalls; and involves a neurological screening by a clinician.
16156771|NCT01728116|Device|EndoBarrier|Endoscopically-delivered and removable device comprised of an anchor that is placed in the duodenal bulb and a 60 cm long impermeable liner that passes distal from the anchor point
16156772|NCT01728116|Procedure|Sham Procedure|Endoscopic evaluation but no device placement
16156773|NCT01728103|Device|APTIMA® Trichomonas vaginalis & APTIMA® COMBO 2® Assays|In Vitro Diagnostic Assays
16156774|NCT01728090|Other|hand sanitizer|alcohol-based, hydroalcoholic gel
16156775|NCT01728077|Drug|Brivaracetam|Flexible dosing, can up and down-titrate as needed.
16156776|NCT01728064|Drug|Placebo|Placebo capsules
16156777|NCT01728064|Drug|EPI-743 400 mg|
16156778|NCT01728064|Drug|EPI-743 200 mg|
16156779|NCT01728051|Drug|Melphalan|
16156780|NCT01728051|Device|Percutaneous Hepatic Perfusion|
16156781|NCT01728038|Behavioral|Cessation Counseling|Parental Smokers will be given brief cessation counseling, nicotine replacement therapy and Quitline connection.
16156782|NCT01728025|Drug|Ranolazine|
16156783|NCT01727986|Drug|tocilizumab [RoActemra/Actemra]|8 mg/kg or 10 mg/kg iv every 4 weeks, 104 weeks
16156784|NCT01727973|Drug|Doxycycline|Tab. Doxycycline 50 mg PO per day for 12 weeks
16156785|NCT01727960|Behavioral|Education and posture correction|a lecture concerning the fine posture for health and exercises
16156786|NCT01727947|Other|MSOME|A total of 200 spermatozoa of each sample will be analyzed under high magnification (x6600) and the incidence of SLV (sperm cells presenting at least one vacuole that occupied > 13% of nuclear area) in each sample will be assessed.
16156787|NCT01727934|Drug|Miravirsen sodium|Subcutaneous injection
16156788|NCT01727921|Device|22 gauge ProCore needle biopsy|22 gauge, EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle
16156789|NCT01727921|Device|25 gauge ProCore needle biopsy|25 gauge, EchoTip® ProCore™ High Definition Ultrasound Biopsy Needle
16156790|NCT01727908|Other|Endoscopy with staining of the mucosa|Staining of the gastric mucosa with acetic acid and Indigocarmine
16156791|NCT01727895|Dietary Supplement|Beta-glucan (Glucan #300®)|
16156792|NCT01727882|Behavioral|Brief feedback|A brief feedback was given on the results of the daily assessments, including a recommendation to the paroled offender and a email report was sent to the probation officer.
16156793|NCT01727882|Behavioral|Daily assessments|Daily assessment of stress, mental symptoms, alcohol and substance use during 30 consecutive days after parole.
16156794|NCT01727869|Drug|REGN1400|
16156795|NCT01727869|Drug|Erlotinib|
16156796|NCT01727869|Drug|Cetuximab|
16156797|NCT01727856|Device|Rehabilitation Measurement Tool|The Rehabilitation Measurement Tool represents a telerehabilitation tool for physical therapy.
16156798|NCT01727843|Drug|Tranexamic Acid|drug and placebo applied topically at end of surgery at hip site.
16156799|NCT01727843|Other|placebo|applied topically to surgical site in OR.
16156800|NCT01727830|Other|Induced Coagulopathy by HES (Tetraspan), Gelatin (Physiogel), Gelatin balanced (Physiogel balanced)|Blood drawn from volunteers
16156801|NCT01727817|Device|Diabetes Assistant (DiAs)|A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night.
16156802|NCT01727804|Other|Laser in caries prevention|
16156803|NCT01727791|Drug|pregabalin (Lyrica)|Subjects will receive a single 150 mg dose of pregabalin in the evening of Day 1, a 150 mg dose of pregabalin in the morning and evening of Day 2 and a 150 mg dose in the morning of Day 3.
16156804|NCT01727778|Biological|Anti-GRP78 monoclonal IgM antibody PAT-SM6|
16156805|NCT01727765|Other|inspiratory muscle training|Both groups will undertake six weeks of inspiratory muscle training (POWERbreathe, H&B International Ltd, UK), six days per week, with the only difference being the load set on the inspiratory muscle training device. For the real inspiratory muscle training group this load will be set to around 50% of maximal inspiratory mouth pressure and for the sham inspiratory muscle training group this load will be set to around 5% of maximal inspiratory mouth pressure.
16156806|NCT01727752|Procedure|Decompression|
16156807|NCT01727739|Device|Linvatec PLLA+TCP|Linvatec PLLA+TCP tibial interference screw fixation will be used in ACL reconstruction.
16156808|NCT01727739|Device|Linvatec PLLA|Linvatec PLLA tibial interference screw fixation will be used in ACL reconstruction.
16156809|NCT01727726|Drug|Brexpiprazole|tablet/capsule
16156810|NCT01727726|Drug|Seroquel XR|tablet/capsule
16156811|NCT01727726|Drug|Placebo|tablet/capsule
16156812|NCT01727713|Drug|Aripiprazole|Open Label: Once-Daily formulation of aripiprazole flex dose regimine
16156813|NCT01727700|Drug|Aripiprazole|Once-daily, tablet
16156814|NCT01727700|Drug|Placebo|
16156815|NCT01727687|Behavioral|behavioral training for crossing road|behavioral training programs for crossing road, such as verbal oral cues and simulated traffic scenes
16156816|NCT01727661|Behavioral|exercise testing with near-infrared spectroscopy|subjects will sit on the ergometer, resting heart rate and BP will be measured for at least 2 minutes. Before testing, each participant will be informed to perform cycling with 0 watt for 2 minutes. Then, exercise testing will be started at 30 watt, and increase 15 watt in male and 10 watt in female every minute until the termination criteria achieved.
16156817|NCT01727661|Behavioral|lung function testing|"spirometry testing: Each participant will then place mouthpiece in mouth and close lips around the mouthpiece. Participants will inhale completely and rapidly and then exhale maximally until no more air could be expelled while maintaining an upright position. Values of FEV1 (forced expiratory volume in 1 second) and FVC (forced vital capacity) will be calculated immediately after the exhalation.
~single-breath carbon monoxide diffusing capacity: Participants will sit on a firm and nose clips will then be attached and mouthpiece be placed in mouth. After participants perform several stable breathes, testing starts with a complete exhalation. Each participant will be instructed to inhale rapidly and completely and then hold for 10 seconds."
16156818|NCT01727661|Behavioral|quality of life|assessing quality of life using short-forum 36 (questionnaire)
16156819|NCT01727648|Behavioral|RT in sequential combination with dCIT|The participants will received 2 weeks of RT therapy using the ArmeoSpring and followed by 2 weeks of distributed CIT therapy. The treatment principles of RT and distributed CIT are the same with those described in the monotherapy of RT or dCIT, respectively.
16156820|NCT01727648|Behavioral|Distributed Constraint-Induced Therapy|The dCIT group will focus on restriction on movement of the unaffected hand by placement of the hand in a mitt for 6 hours/day and intensive training of the affected UL in functional tasks for 1.5 hours/weekday over the 4 weeks. Participants in this group will focus on the intensive training of the affected arm in functional activities with behavioral shaping.
16156821|NCT01727648|Behavioral|Robot-Assisted Therapy|Participants will receive 20 training sessions (1.5 hours/day, 5 days/week for 4 consecutive weeks). The ArmeoSpring (Hocoma AG, Switzerland) will be used in this project. It is a 5 degree-of-freedom skeleton mechanism that automates arm movement in a gravity-supported and computer-enhanced environment. The design of the arm support component of the ArmeoSpring is based on Wilmington Robotic Exoskeleton, an antigravity arm support. Instrumentation of the ArmeoSpring with position sensors at each joint enables it to be used as a 3D input device for computer game play with the hemiparetic arm. A custom software package named Vu Therapy will be also used in this project. Games were designed to simulate functional arm movements to provide training in a simple virtual reality environment.
16156822|NCT01727648|Behavioral|Dose-matched control therapy|Participants will receive 20 training sessions (1.5 hours/day, 5 days/week for 4 consecutive weeks). This group will received a structured protocol using conventional occupational therapy techniques such as neuro-developmental techniques with emphasis on functional tasks and muscle strengthening. The treatment protocol will include (1) passive range of motion exercises, stretching of the affected limb, or facilitatory and inhibitory techniques for 15 to 20 minutes, (2) fine motor or dexterity training for 20 minutes, (3) arm exercises or gross motor training for 20 minutes, (4) muscle strengthening of the affected upper limb for 15 to 20 minutes, and (5) activities of daily living or functional tasks training for 15 to 20 minutes.
16156823|NCT01727635|Other|body-mind-spirit group therapy|8-session therapy
16156824|NCT01727622|Drug|FDG-PET|Diagnostic: FDG-PET imaging to examine neuronal health
16156825|NCT01727622|Other|ASL-MRI|Arterial-Spin Labeled MRI to examine cerebral blood flow
16156826|NCT01727622|Procedure|Lumbar Puncture|Lumbar puncture to acquire a small amount of cerebrospinal fluid for protein level analyses. Note that this will not be required in all participants.
16156827|NCT01727609|Dietary Supplement|Milk feed (breast milk or formula milk)|
16156828|NCT01727596|Other|taping|Briefly, the patella was manually displaced medially, and maintained in the position by Tex Tape (Kinesio Holding Corporation, Albuquerque, NM)
16156829|NCT01727583|Dietary Supplement|meal intake|Intake of meals characterized by lipid composition
16156830|NCT01727583|Dietary Supplement|Placebo|
16156831|NCT01727570|Dietary Supplement|Whey Protein (Immunocal®)|The amount of Immunocal® whey protein the patient is required to take daily will be determined on an individual basis by the nutritionist according to the assessed protein deficit in the patient's diet.
16156832|NCT01727557|Procedure|regional anesthesia|Regional anesthesia will be compared to local anesthesia
16156833|NCT01727557|Procedure|local anesthesia|Regional anesthesia will be compared to local anesthesia
16156834|NCT01727544|Procedure|cartilage cap occlusion surgery|placement of a cartilage cap over the dome of the superior semicircular canal through a combined transmastoid and tegmen mini- craniotomy approach.
16156835|NCT01727531|Drug|Chloroquine diphosphate|250 mg chloroquine once a day by mouth beginning one week prior to beginning radiation therapy and continue for a total of five weeks
16156836|NCT01727505|Device|Sequence A: Conventional-Volume Guarantee|"This is a crossover study. Infants will be randomly assigned to one of two sequences.
~In sequence A, the infant will undergo a 24-hour period of conventional mechanical ventilation followed by a 24 hour period of volume guarantee ventilation.
~Both conventional mechanical ventilation and volume guarantee ventilation will be provided by the same neonatal ventilator (AVEA, CareFusion Inc, Yorba Linda, CA).
~During the 24 hour period of conventional mechanical ventilation, the infant will receive mechanical ventilation with the settings determined by the clinical team.
~During volume guarantee ventilation, the set tidal volume to be maintained by the ventilator will be the average tidal volume delivered by the ventilator prior to start of study."
16156921|NCT01726777|Dietary Supplement|Vitamin D|Vitamin D3 supplemented cheddar cheese
16156837|NCT01727505|Device|Sequence B: Volume Guarantee-Conventional|"This is a crossover study. Infants will be randomly assigned to one of two sequences.
~In sequence B, the infant will undergo a 24-hour period of volume guarantee ventilation followed by a 24 hour period of conventional mechanical ventilation.
~Both conventional mechanical ventilation and volume guarantee ventilation will be provided by the same neonatal ventilator (AVEA, CareFusion Inc, Yorba Linda, CA).
~During the 24 hour period of conventional mechanical ventilation, the infant will receive mechanical ventilation with the settings determined by the clinical team.
~During volume guarantee ventilation, the set tidal volume to be maintained by the ventilator will be the average tidal volume delivered by the ventilator prior to start of study."
16156838|NCT01727492|Drug|Antioxidantia|
16156839|NCT01727479|Other|Ribose|After each of the 3km time trial (3 in total), participants will be asked to drink the experimental product (or placebo) incorporated in a sports drink.
16156840|NCT01727479|Other|Placebo|
16156841|NCT01727466|Behavioral|Facing Your Fears|FYF is a group cognitive behavior therapy that includes parent and child participation. Groups meet weekly for 1 1/2 hours duration, for 14 consecutive weeks.
16156842|NCT01727453|Drug|warfarin|Warfarin in anticoagulant dose
16156843|NCT01727453|Drug|Bemiparina|"Group 2 (VKA oral anticoagulation: warfarin), which is the control group will receive VKA anticoagulation as before they had the bleeding episode, with regular monitoring by measurement of prothrombin time (INR). Patients taking acenocoumarol before bleeding episode will be treated with warfarin and the once who were receiving warfarin will continue with the same treatment. Treatment control is performed by measuring the INR periodically.
~Randomization will be performed using sealed opaque envelopes that contain the treatment option that will be obtained through a list of random numbers generated by computer."
16156844|NCT01727427|Drug|Heparin, fondaparinux, vitamin-K antagonists, aspirin|Parenteral or oral anticoagulant Antiplatelet agent
16156845|NCT01727414|Drug|OROS-Methylphenidate and placebo for inattentive type pts|Every participant receives low dose MPH, medium dose MPH, high dose MPH, and placebo for one week each in a triple-blinded fashion.
16156846|NCT01727414|Drug|OROS-Methylphenidate and placebo for combined type pts|Every participant receives low dose MPH, medium dose MPH, high dose MPH, and placebo for one week each in a triple-blinded fashion.
16156847|NCT01727401|Drug|Fondaparinux|Fondaparinux once daily sc injections at a dose of 2.5 mg if renal clearance of creatinine above 50 ml/min or Fondaparinux once daily sc injections 1.5 mg if renal clearance of creatinine between 20 and 50 ml/min
16156848|NCT01727388|Procedure|lateral decubitus|
16156849|NCT01727388|Procedure|supine decubitus|
16156850|NCT01727375|Other|Circadian light|"Artificial ceiling lighting throughout the day will be provided by the Philips HealWell system, CE marked, which is able to deliver varying light levels and warmer or cooler light according to the time of the day (circadian light). Emergency or examination lighting can be set on demand as circumstances require.
~Lighting conditions at the patients bedside will be characterized by transformations on the time-series of light levels as measured by a luxmeter. The following metrics will be used for lighting characterization in a period of 24h: mean levels of bright and dark periods, contrast between bright and dark periods, clustering of bright and dark periods, and circadian variation."
16156851|NCT01727362|Other|Usual care + acupuncture|Patients of this group receive a semi-standardized acupuncture treatment over 6 month in addition to usual care
16156852|NCT01727362|Other|Usual care|Patients of this group receive usual care only
16156853|NCT01727349|Other|HbA1c measurement|
16156854|NCT01727349|Other|Oral Glucoce Tolerance Test|Oral Glucoce Tolerance Test
16156855|NCT01727336|Drug|Dalantercept and axitinib|
16156856|NCT01727336|Drug|Placebo and axitinib|
16156857|NCT01727297|Device|REVEAL Implantable Cardiac Monitor|
16156858|NCT01727284|Procedure|MR-guided cryoablation|
16156859|NCT01727271|Drug|Tenofovir|
16156860|NCT01727271|Biological|Pegylated interferon alpha-2b|
16156861|NCT01727258|Device|Mouth Rinse|Mouth rinse 12027-033 used twice daily for 28 days after brushing.
16156862|NCT01727258|Drug|Fluoride Toothpaste|Fluoride Toothpaste used daily for 28 days.
16156863|NCT01727258|Drug|Potassium Nitrate Toothpaste|Potassium Nitrate Toothpaste used daily for 28 days.
16156864|NCT01727245|Other|Obese|gastric bypass
16156865|NCT01727245|Other|Control group|Cholecystectomy and anti-reflux surgery
16156866|NCT01727206|Drug|Tocilizumab|
16156867|NCT01727193|Drug|Azathioprine|The basic therapy of each group is cholinesterase inhibitors (pyridostigmine 36mg / kg / d). Group 1 glucocorticoid + Azathioprine: Glucocorticoid (0.25mg/kg/d )plus Azathioprine at a starting dose of 50mg/d for 14 days, then increase up to 2mg/kg in 2 weeks.If no adverse events occurred , maintain the dose until 48 weeks.
16156868|NCT01727193|Drug|Leflunomide|The basic therapy of each group is cholinesterase inhibitors (pyridostigmine 36mg / kg / d). Group 2 glucocorticoid + Leflunomide: Glucocorticoid (0.25mg/kg/d )plus Leflunomide 20mg/d for adult, 10mg/d for child. if no adverse events occurred , maintain the dose until 48 weeks.
16156869|NCT01727180|Other|Questionnaire based on the McGill Pain Questionnaire|Interview questionnaire based on the short form of the McGill Pain Questionnaire
16156870|NCT01727167|Drug|200ppm CO for one hour|This is the study intervention. The treatment group will breath 200 ppm of CO for one hour over the three days immediately prior to surgery.
16156871|NCT01727167|Other|Control|This group will breath room air for one hour per day over the course of the three days immediately prior to surgery.
16156872|NCT01727154|Biological|Sipuleucel-T|Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
16156873|NCT01727141|Drug|QVA149|QVA149 was supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI
16156874|NCT01727141|Drug|QAB149|QAB149 was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.
16156875|NCT01727141|Drug|NVA237|NVA237 was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.
16156876|NCT01727141|Drug|Placebo|Placebo was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.
16156877|NCT01727128|Drug|BKM120|
16156922|NCT01726764|Other|St John's Wort|
16156923|NCT01726764|Drug|Metformin|
16157318|NCT01723774|Drug|PD0332991|
16156878|NCT01727115|Other|Infant Formula Feeding|"Assigned formula (Althera® or Nutramigen®) for a 4 weeks period.
~If the challenge is positive: The children continue the assigned formula
~If the challenge is negative: A Follow up formula is given
~(Nan pro2) if child > 6 months
~(Nan pro1) if child < 6 months"
16156879|NCT01727089|Biological|Anti-Endoglin Chimeric Monoclonal Antibody TRC105|Given IV
16156880|NCT01727089|Biological|Bevacizumab|Given IV
16156881|NCT01727089|Other|Laboratory Biomarker Analysis|Correlative studies
16156882|NCT01727089|Other|Pharmacological Study|Correlative studies
16156883|NCT01727076|Other|Laboratory Biomarker Analysis|Correlative studies
16156884|NCT01727076|Other|Pharmacological Study|Correlative studies
16156885|NCT01727076|Biological|Recombinant Human Interleukin-15|Given SC
16156886|NCT01727063|Procedure|Cell Therapy|Intramyocardial injection of autologous bone marrow-derived cells
16156887|NCT01727050|Device|Fibrin sealant spray|Fixation of mesh would be performed using fibrin sealant spray applied with a laparoscopic spray catheter
16156888|NCT01727050|Device|Mechanical stapling|Fixation of mesh would be performed using mechanical staplers
16156889|NCT01727037|Procedure|Bronchoscopic intrabullous autologous blood instillation|
16156890|NCT01727024|Drug|Tiotropium|Tiotropium via Respimat® device once a day
16156891|NCT01727024|Drug|Indacaterol|Indacaterol via Breezhaler® device once a day
16156892|NCT01727011|Radiation|IPAS|
16156893|NCT01726998|Other|Robot-assisted gait therapy|Two groups received 30 minutes conventional gait training including Neurodevelopmental Treatment(NDT) basically. Robot-assisted gait therapy for 30 minutes with Lokomat® (Hocoma, Zurich, Switzerland) daily for 4 weeks, and the conventional gait training group received additional daily conventional gait training with NDT for the same periods.
16156894|NCT01726998|Other|conventional gait training|Two groups received 30 minutes conventional gait training including Neurodevelopmental Treatment(NDT) basically. Robot-assisted gait therapy for 30 minutes with Lokomat® (Hocoma, Zurich, Switzerland) daily for 4 weeks, and the conventional gait training group received additional daily conventional gait training with NDT for the same periods.
16156895|NCT01726985|Other|Parameter Based Clinical Disposition|"Parameter Based Clinical Disposition'
~Physicians will initiate / titrate medications and obtain consults as usual but are highly encourage to keep patients in the hospital until at least 2 of the following 3 criteria are met:
~NT-ProBNP reduction of > 23% from peak value during admission
~Fluid Reduction of > 1.3L (orders for I/O q8h required)
~Serum Sodium of > 135 mmol/L the day of planned discharge"
16156896|NCT01726946|Drug|VX-135|12 weeks of VX-135
16156897|NCT01726946|Drug|ribavirin|12 weeks of ribavirin
16156898|NCT01726933|Drug|LAS41008|gastric resistant tablet, weekly up-titration up to maximal tolerated dosage
16156899|NCT01726933|Drug|LASW1835|gastric resistant tablet, weekly up-titration up to maximal tolerated dosage
16156900|NCT01726933|Drug|Placebo|gastric resistant tablet, weekly up-titration up to maximal tolerated dosage
16156901|NCT01726920|Drug|naratriptan + naproxen|Tablets containing naratriptan 2,5 mg + naproxen 500 mg
16156902|NCT01726920|Drug|naratriptan|Tablets containing naratriptan 2,5 mg
16156903|NCT01726920|Drug|naproxen|Tablets containing naproxen 500 mg
16156904|NCT01726907|Device|Robotic SMG resection|The surgical procedure and the considerations for surrounding neurovascular structures were similar to that of the endoscope-assisted SMG resection. The da Vinci surgical system (Intuitive Surgical Inc., Sunnyvale, CA) including a 30° dual channel endoscopic arm and two instrument arms was introduced. The SMG was retracted using the 5-mm Maryland forceps on the left and the dissection was conducted using a 5-mm spatula monopolar cautery or a Harmonic curved shears on the right. A Yankauer suction handled by a bed-side assistant could be used for counter traction of the gland which facilitated the dissection procedure.
16156905|NCT01726907|Device|Endoscopic SMG resection|An assistant held a 10-mm 30° rigid endoscope allowing the operating surgeon to use both hands. Surgical resection tools such as dissector and Harmonic scalpel (Harmonic Ace 23E®; Johnson & Johnson Medical, Cincinnati, OH, USA) was held in the right hand and a Yankauer suction or a Debakey forcep was held on the left for traction of the SMG. The dissection plane between the capsule of the SMG was conducted under magnified endoscopic view using the the blade of the Harmonic scalpel and the endoscopic dissector. Routine identification of the marginal mandibular branch of the facial nerve was unnecessary in SMG resection, since the dissection plane was always deep to the middle layer of the deep cervical fascia which includes the fascia of the gland. The Wharton's duct, facial artery and vein were ligated using the Harmonic scalpel or vascular clip.
16156906|NCT01726894|Device|Irreversible Electroporation|
16156907|NCT01726881|Device|Thermal stimulation|"Stimulation using a Thermal Sensory Analyzer:
~2001, Maddock ltd., Israel."
16156908|NCT01726881|Device|Mechanical stimulation|Stimulation using Semmes-Weinstein-Monofilament Touch Test Sensory Evaluators
16156909|NCT01726881|Device|Transcutaneous Electrical Nerve Stimulator (TENS)|A portable stimulator designed to Physical treatment of pain. TENS - Cedar rehab X2. Chattanooga group.USA.
16156910|NCT01726868|Device|Liposorber LA-15 System|Six sessions of blood purification treatment with Liposorber LA-15 System.
16156911|NCT01726855|Procedure|vascularized finger dorsal fascial flap|
16156912|NCT01726842|Device|Pediatric Vision Scanner|Subject is scanned with a 2.5 second pediatric vision scanner device test.
16156913|NCT01726829|Device|MD-Logic Artificial Pancreas (MDLAP) system|
16156914|NCT01726829|Procedure|sensor augmented pump therapy|
16156915|NCT01726816|Drug|Probucol 250mg/day|Probucol 250mg + Placebo
16156916|NCT01726816|Drug|Probucol 500mg/day|Probucol 500mg + Placebo
16156917|NCT01726816|Drug|Placebo|Probucol matching placebo
16156918|NCT01726803|Other|Early Physical Therapy with Usual Care|The early physical therapy arm includes 4 total sessions. The first 2 sessions include use of thrust spinal manipulation with exercises for range of motion and strengthening of the spine. The final 2 sessions include the exercise component only.
16156919|NCT01726803|Other|Usual Care|The usual care intervention includes advice and education to remain active and provision of the Back Book highlighting these recommendations. Pharmaceuticals may be prescribed at the discretion of the primary care provider. Follow-up visits to primary care provided are recommended for all patients dissatisfied with their progress.
16156920|NCT01726777|Dietary Supplement|Control|Normal cheddar cheese
16156926|NCT01726738|Drug|BRAF inhibitor dabrafenib and MEK inhibitor trametinib|Patients will receive the BRAF inhibitor dabrafenib and MEK inhibitor trametinib orally at the RP2D determined in the Phase I/II study (BRF113220): trametinib 2mg QD and dabrafenib 150 mg BID on a continuous basis. A cycle will be defined as 3 weeks in duration. Cycles will be repeated until disease progression (clinical or radiological). Patients may remain on treatment after progression (at the discretion of the investigator) as long as they are still experiencing clinical benefit.
16156927|NCT01726725|Drug|desflurane|
16156928|NCT01726712|Other|Supportive Care|Provide emotional support. Provide practical support. Support friend/family by helping him find information or help for those with HIV in the community
16156929|NCT01726686|Drug|Ropivacaine|100 ml Ropivacaine 10mg/ml in a continuous infusion pump set at 2 ml/hour
16156930|NCT01726686|Drug|Placebo|
16156931|NCT01726673|Device|Transcranial Direct Current Stimulation (tDCS)|
16156932|NCT01726673|Device|Placebo sham|
16156933|NCT01726660|Device|IMT Robotic Arm therapy|Interactive Motion Technologies (IMT) planar and wrist robots for robotic arm therapy
16156934|NCT01726634|Other|Elastic Tapping|
16156935|NCT01726621|Device|Medtronic MiniMed 620G or 640G Insulin Pump|Subjects to use the Medtronic MiniMed 620G or 640G Insulin Pump and Guardian Link transmitter to manage their diabetes for 4 - 6 weeks.
16156936|NCT01726608|Procedure|Comparison of active versus sham radiofrequency neurotomy with Simplicity III|
16156937|NCT01726582|Drug|Targeted chemotherapy prior to surgery|The molecular profile from the biopsy before surgery will point to a particular chemotherapy treatment.
16156938|NCT01726582|Drug|standard FOLFIRINOX chemotherapy prior to surgery|A biopsy of the borderline tumor does not provide a molecular profile that can be used to target treatment. The treatment will be standard FOLFIRINOX chemotherapy regimen.
16156939|NCT01726582|Drug|Gemcitabine after surgery|Chemotherapy treatment with Gemcitabine.
16156940|NCT01726582|Other|No additional therapy after surgery|The molecular profile of the tumor that was removed during surgery points to a lack of treatment affect for available therapies. No additional therapy is recommended.
16156941|NCT01726582|Drug|Targeted chemotherapy after surgery|The molecular profile from the surgical specimen will point to a particular chemotherapy treatment.
16156942|NCT01726582|Radiation|Chemoradiotherapy (cXRT)|A radio-sensitizing chemotherapy agent (either Gemcitabine or Capecitabine) will be given. Using 3D conformal or IMRT techniques, patients will receive a total dose of 50.4 Gy prescribed to the 95% isodose at 1.8 Gy/fraction (28 fractions).
16156943|NCT01726569|Behavioral|film and trained counseling|Subjects will be asked to watch a 5-10 min film and participate in a 10-15 min pre-operative counseling session with a trained doctor/nurse. Subjects will also participate in a 5 min post-operative counseling session.
16156944|NCT01726569|Other|traditional counseling|Subjects will be not participate or participate in a pre-operative/post-operative counseling session with a rural hospital's doctor/nurse as usual traditional methods.
16156945|NCT01726556|Device|Rigid thoracoscope (Richard Wolf GmbH, Knittlingen, Germany)|Pleuroscopy using a rigid thoracoscope manufactured by Richard Wolf GmbH, Knittlingen, Germany
16156946|NCT01726556|Device|Semirigid thoracoscope (model LTF-160Y1, Olympus, Japan)|Pleuroscopy using a semirigid thoracoscope model LTF-160Y1, manufactured by Olympus Medical Systems Corporation, Tokyo, Japan
16156947|NCT01726543|Procedure|Canaloplasty and phacoemulsification|As soon as the two scleral flaps (deep and superficial -similar to deep sclerectomy) are dissected, the phacoemulsification is performed and a artificial lense is implanted. After excision of the deep flap the descemets window and ostia of Schlemm canal are created, the microcatheter is placed in the canal and is advanced 12 clock hours within the canal. Surgeon observes the location of beacon tip through sclera and injects the Healon GV. When the catheterisation of the canal is done, the distal tip is exposed and a 10-0 propylene suture is tied to the distal tip. Then the microcatheter is withdrawn and suture is pulled into the canal. As it appears at the other ostium of canal the microcatheter it separated from the suture. A loop is created, encircling the inner wall of Schlemm canal. Then suture loop is tightened to distend the trabecular meshwork inward, placing the tissues in tension, the locking nods are added. The superficial flap is sutured watertight to prevent bleb formation.
16156948|NCT01726543|Procedure|Non-penetrating deep sclerectomy and phacoemulsification|A fornix-based conjunctival ﬂap is dissected superiorly, and the sclera is exposed. A 5 x 5 mm scleral ﬂap is dissected anteriorly into clear cornea using a No. 69 Beaver blade. Then the phacoemulsification procedure is performed and a artificial lense is implanted. Afterwards second deep scleral ﬂap is dissected and excised leaving only a thin layer of deep sclera over the choroid. Anteriorly, the dissection is made down to remove Schlemm's canal and juxtacanalicular trabeculum. Excision of the corneal stroma is performed more anteriorly down to Descemet's membrane. This allows aqueous humor to percolate through the thin trabecular-Descemet's membrane. The superficial scleral ﬂap is then closed with two 10-0 monofilament nylon sutures.The conjunctiva is sutured down over the limbus with one interrupted 10-0 monofilament nylon suture at each corner.
16156949|NCT01726530|Drug|transdermal fentanyl patch (50 mcg/hour)|
16156950|NCT01726530|Drug|Placebo|
16156951|NCT01726517|Drug|LDV/SOF|LDV 90 mg/SOF 400 mg FDC tablet administered orally once daily
16156952|NCT01726517|Drug|RBV|RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16156953|NCT01726504|Device|electro-acupuncture|Procedure: electro-acupuncture; Points:Tianshu (ST25) Fujie(SP14), Shangjuxu (ST37).Pierced the skin, needles are inserted 30to70mm into bilateral ST25 and SP14 vertically until piercing the abdominal muscle layer.Electric stimulator is applied to bilateral ST25 and SP14 with dilatational wave, 10/50 Hz and electric current 0.1-1.0mA. The participant's abdominal muscle twitching mildly is the appropriate dose. Bilateral ST37 are inserted 25-30mm and then twirling lifting and thrusting for 3 times.Local sour and heavy feeling is appropriate dose. Steady small twirling lifting and thrusting 3 times in all. 30 min/per day/per session.During the 8 weeks treatment, the first 2 weeks,5 sessions per week, and 3 sessions per week in the rest 6 weeks,28 sessions for each patients in total.
16156984|NCT01726283|Drug|Riboflavin|Riboflavin will be instilled prior to corneal cross linking.
16156985|NCT01726270|Drug|tamsulosin|0.4 mg
16156986|NCT01726257|Device|Nellix System|Nellix Endovascular Aneurysm Sealing System is the only arm for this study. This is a single arm study.
16157319|NCT01723774|Drug|Anastrozole|
16156954|NCT01726504|Device|sham electro-acupuncture|Procedure:sham electro-acupuncture;Points:Sham Tianshu(ST25),sham Fujie(SP14),sham Shangjuxu (ST37).Sham points location:20mm away from ST25,middle of Spleen and Stomach Channel;30mm from SP14,middle of Spleen and Stomach Channel; one point beside ST37,middle of Stomach and Gallbladder Channel; Performance:The needle is inserted with needle of 0.30×25mm by 3-5mm. No twirling lifting and thrusting. The electric stimulator is applied to bilateral sham ST25 and sham SP14 with dilatational wave,10/50 Hz and electric current 0.5mA.The mental wire has been cut off with a same outlook as the treatment group.The electric stimulator is looked normal but with no current output. Length of Treatment and the treatment sessions are the same as treatment group.
16156955|NCT01726478|Drug|2.5 units Oxytocin|Administration of 2.5 units of oxytocin after clamping of umbilical cord
16156956|NCT01726478|Drug|10 units Oxytocin|Administration of 10 units of oxytocin after clamping of umbilical cord
16156957|NCT01726465|Drug|Methylprednisolone|Methylprednisolone is a glucocorticoid, which is an adrenocortical steroid. The chemical name for methylprednisolone is pregna-1,4-diene-3,20-dione, 11,17,21-trihydroxy-6-methyl-, (6α,11β)-and the molecular weight is 374.48. It is an analog of naturally occurring glucocorticoid (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states. Methylprednisolone is used for their potent anti-inflammatory effects in disorders of many organ systems, it modify the body's immune responses to diverse stimuli. The usual dosage of medication varies in relation to pathology for which is prescribed: normally varies from about 40-60 mg per day up to very high doses of 30 mg/kg bolus as used in spinal cord injury.
16156958|NCT01726465|Drug|N-acetylcysteine|Acetylcysteine is the N-acetyl derivative of the naturally occurring amino acid, L-cysteine. Chemically, it is N-acetyl-L-cysteine. The compound is a white crystalline powder which melts at 104°-110°C and has a very slight odor. Acetylcysteine may form cysteine, disulfides, and conjugates in vivo (N, N'-diacetylcysteine, N-acetylcysteine- cysteine, N-acetylcysteine-glutathione, N-acetylcysteine-protein, etc). No metabolites were identified. Acetylcysteine likely protects the liver by maintaining or restoring the glutathione levels, or by acting as an alternate substrate for conjugation with, and thus detoxification of, the reactive metabolite.
16156959|NCT01726452|Drug|Epirubicin|50mg/m2 on Day 1 of each cycle only (i.e. every 21 days)
16156960|NCT01726452|Drug|Cisplatin / Oxaliplatin|Cisplatin, 60mg/m2 on day 1 of each cycle only (i.e. every 21 days). OR Oxaliplatin,130 mg/m2 on Day 1 of each cycle (i.e. every 21 days) The choice between administering Cisplatin or Oxaliplatin is at the discretion of the investigator.
16156961|NCT01726452|Drug|5 Flourouracil/ Capecitabine|5-Flourouracil 200 mg/m2/day every day for 21 days OR Capecitabine 625 mg/m2 twice daily orally). The choice between administering 5 Flourouracil or Capecitabine is at the discretion of the investigator.
16156962|NCT01726452|Radiation|(41.4 Gy/23 fractions)|Patient will receive 4.5 weeks of radiation therapy (41.4 Gy/23 fractions).
16156963|NCT01726452|Drug|Paclitaxel|50mg/ m2 Paclitaxel dose administered on Days 1, 8, 15,22 and 29. Dexamethasone, Chlorphenamine and Ranitidine dose given per local standard practice. NACL infusion per local standard practice. Ondansetron dose given per local standard practice on Days 1, 8, 15, 22 and 29.
16156964|NCT01726452|Drug|Carboplatin|Dose determined as per calculation, infused on Days 1, 8, 15, 22 and 29
16156965|NCT01726452|Drug|Docetaxel|Docetaxel, 50 mg/m², day 1 of each cycle (i.e. every 14 days)
16156966|NCT01726452|Drug|Oxaliplatin|85 mg/m², day 1 of each cycle (i.e. every 14 days)
16156967|NCT01726452|Drug|Leucovorin|200 mg/m², day 1 of each cycle (i.e. every 14 days).
16156968|NCT01726452|Drug|5-Fluorouracil|2600 mg/m² Day 1 of each cycle (i.e. every 14 days) Dexamethasone or equivalent, 8mg, twice daily, Day before, day of and day after OR administered as per standard practice
16156969|NCT01726426|Dietary Supplement|Probiotic|Each capsule Probiotics (Lactobacillus- 2 billion, Bifidobacterium- 1 billion, fructo-oligosaccharide): 1 capsule twice daily orally for 12 weeks
16156970|NCT01726413|Drug|GRC 17356|
16156971|NCT01726413|Drug|Matching Placebo|
16156972|NCT01726400|Drug|Pegylated interferon alpha|Subcutaneous weekly pegylated interferon alpha and daily oral ribavirin treatment as per standard treatment. The dosages for interferon and ribavirin are as per therapeutic guidelines and are based on weight, genotype and previous treatments.
16156973|NCT01726400|Drug|Ribavirin|Subcutaneous weekly pegylated interferon alpha and daily oral ribavirin treatment as per standard treatment. The dosages for interferon and ribavirin are as per therapeutic guidelines and are based on weight, genotype and previous treatments.
16156974|NCT01726387|Behavioral|Psychosocial Counseling|Depending on their condition, counseling assistants support patients in self-management support, enhancing self-efficacy, reducing psychological symptoms
16156975|NCT01726387|Behavioral|Usual Care|Depending on the conditions, patients get usual care of their general practitioner
16156976|NCT01726374|Drug|BEP(500)|"One cycle of BEP(500):
~Etoposide 165 mg/m2 IV infusion - days 1, 2, 3 Cisplatin 50 mg/m2 IV infusion - days 1, 2 Bleomycin 30,000 IU IV infusion - days 1 (or 2), 8, 15"
16156977|NCT01726361|Behavioral|Multidimensional Treatment Foster Care|Out of home placement in MTFC family for 10-12 months
16156978|NCT01726361|Behavioral|Treatment as usual|Other kinds of out of home placement
16156979|NCT01726348|Drug|No intervention|This is an observational study. Darunavir will be administered as per the recommended doses and will be given orally every 4 weeks for a period of 24 weeks. For treatment-naive and treatment-experienced adult patients with no darunavir resistance associated substitutions: Darunavir 800 mg will be administered with ritonavir 100 mg once daily with food. For treatment-experienced adult patients with at least one darunavir resistance associated substitution: Darunavir 600 mg will be administered with ritonavir 200 mg twice daily with food.
16156980|NCT01726335|Drug|Risperidone prolonged release|Risperidone will be administered as intramuscular injection as 25 milligram (mg) every two weeks, from Week 1 to 50, wherein after Week 3, dose may be adjusted up to 50 mg at physician criterion. For first two weeks, previous oral antipsychotic drug will be maintained and the dose will be gradually decreased and will cease at Week 3.
16156981|NCT01726296|Other|educational intervention|Complete an educational intervention based on NCCN guidelines and disease-specific issues related to survivorship care
16156982|NCT01726296|Other|medical chart review|Complete patient medical chart audit
16156983|NCT01726283|Device|Corneal Cross-Linking|Corneal cross-linking procedure conducted during vision correction surgery.
16157320|NCT01723774|Drug|Goserelin|
16156987|NCT01726244|Behavioral|Multidisciplinary Intervention|Health education sessions consisting in controlling disease and stress asociated to it, and modifying eating habits
16156988|NCT01726205|Drug|Pregabalin and normal saline infusion, PRG|
16156989|NCT01726205|Drug|Pregabalin and ropivacaine 02% infusion|
16156990|NCT01726205|Drug|Placebo drug, normal saline infusion|
16156991|NCT01726192|Procedure|Placement of a femoral catheter with the hydrolocalization technique|Placement of femoral nerve catheter with the hydrolocalization technique, using ropivacaine 0.6%
16156992|NCT01726192|Procedure|Placement of a femoral neurostimulating catheter|
16156993|NCT01726179|Device|Icon infiltration|"Patients and their guardians will be instructed to use dental floss to remove dental biofilm in both proximal sites once a day and to brush teeth with fluorated toothpaste twice a day. Besides that, test lesion will be infiltrated with a low viscosity resin (Icon, DMG, Hamburg, Germany). The test lesions will be treated using Icon (DMG, Hamburg, Germany) following the instruction for use.
~A sub-sample with children with indication for a composite restoration in at least one proximal surface will be selected for the analysis of dental anxiety and stress."
16156994|NCT01726179|Device|control|"Patients and their guardians will be instructed to use dental floss to remove dental biofilm in both proximal sites once a day and to brush teeth with fluoridated toothpaste twice a day.
~A sub-sample with children with indication for a composite restoration in at least one proximal surface will be selected for the analysis of dental anxiety and stress."
16156995|NCT01726166|Procedure|Suprapubic Aspiration|Pain management will be performed as per our NICU protocols by administering 24% sucrose prior to both procedures to ensure adequate pain control. Additional or different analgesia may be used depending on the patient's specific clinical situation. We will use a chlorhexidine 0.05% with no cetrimide solution as the cleaning solution.
16156996|NCT01726166|Procedure|Urinary Catheterization|Pain management will be performed as per our NICU protocols by administering 24% sucrose prior to both procedures to ensure adequate pain control. Additional or different analgesia may be used depending on the patient's specific clinical situation. We will use a chlorhexidine 0.05% with no cetrimide solution as the cleaning solution.
16156997|NCT01726153|Behavioral|Condom-HIM|The tailored on-line Condom-HIM intervention is composed of a single session involving activities to increase individuals self-efficacy and intention to use condoms.
16156998|NCT01726140|Procedure|Helmet CPAP|the patient will receive CPAP treatment, at a PEEP level of 10 cmH2O and a FiO2 adjusted to maintain SpO2>95%, for six hours. After three hours of treatment a blood gas analysis will be evaluated and the patient will proceed with the treatment for three more hours. At the end of the six hours, the patient will repeat a spontaneous breathing trial with a Venturi mask at FiO2 = 50%, for 15 minutes and than a blood gas analysis will be repeated: if the PaO2/FiO2 will be < 200 the patient will received a second treatment with CPAP; if PaO2/FiO2 will be >200, the patient will stop the treatment.
16156999|NCT01726140|Procedure|Venturi Mask|the patient will maintain spontaneous breathing, with a system for oxygen delivery at a FiO2 adjusted to maintain SpO2>95%, for six hours. After three hours of treatment a blood gas analysis will be evaluated and the patient will proceed with the treatment for three more hours. At the end of the six hours, the patient will do a trial for 15 minutes and after that a blood gas analysis will be repeated: if the PaO2/FiO2 will be < 200 the patient will go on with the control treatment; if PaO2 /FiO2 will be >200, the patient will stop the treatment.
16157000|NCT01726127|Other|Broccoli and Brussels Sprouts|
16157001|NCT01726127|Dietary Supplement|Cruciferous Complete|
16157002|NCT01726127|Other|Placebo|
16157003|NCT01726114|Device|Non-invasive Optical Glucose Monitor™|Test device
16157004|NCT01726114|Device|YSI blood glucose analyzer|Reference device
16157005|NCT01726088|Drug|Modafinil|we will compare the effect of modafinil and matching placebo on clinical and objective measures detailed above.
16157006|NCT01726075|Drug|COLIRIOBCN070660|One drop per eye twice a day during 24 months
16157007|NCT01726075|Drug|Placebo|One drop per eye twice a day during 24 months
16157008|NCT01726075|Drug|Brimonidine|One drop per eye twice a day during 24 months
16157009|NCT01726062|Behavioral|Motivational Interviewing plus Incentives|"Two hospital-based, face-to-face MI+ sessions
~Two home-based MI+ sessions
~Attendance at each session and for the establishment of a household smoking ban at two timepoints post-discharge"
16157010|NCT01726062|Behavioral|Conventional Care (CC)|Participants in this arm will receive brochures and a brief information meeting in the NICU.
16157011|NCT01726049|Drug|Sildenafil|Sildenafil administered orally 3 times per day 20 mg for the first 2 weeks, followed by 3 times 60 mg for 10 weeks
16157012|NCT01726049|Drug|Placebo|Placebo tablets 3 times per day 20 mg foor de first 2 weeks, followed by 3 times 60 mg for 10 weeks
16157013|NCT01726036|Device|Gomco Circumcision Clamp|Neonatal male circumcision utilizing the Gomco Circumcision Clamp
16157014|NCT01726036|Device|Mogen Circumcision Clamp|Neonatal male circumcision utilizing the Mogen Circumcision Clamp
16157015|NCT01726023|Drug|Ceftazidime-avibactam|Ceftazidime-Avibactam powder for concentrate for solution for infusion 2000 mg/500 mg
16157016|NCT01726023|Drug|metronidazole|Metronidazole 500mg/100ml solution for infusion
16157017|NCT01726023|Drug|Meropenem|Meropenem powder for solution for infusion 1000mg
16157018|NCT01726010|Device|22-G Procore Needle|
16157019|NCT01725997|Procedure|hook plate|Surgery with hook plate followed by physiotherapy
16157020|NCT01725997|Other|Physiotherapy|Patients will be following a program specific for AC joint dislocations
16157021|NCT01725958|Dietary Supplement|Nutritional supplement and protein shakes|
16157022|NCT01725945|Behavioral|Dietary Approaches to Stop Hypertension dietary pattern|The intervention will employ a series of small group and individual sessions, followed by periodic telephone contacts, to help participants make appropriate dietary changes and develop the skills to maintain these changes over the long term. The initial 3 months of intensive intervention will involve 8 group and 3 individual sessions for 45-60 minutes each. During the next 3 months, participants will receive counseling phone calls once per month for 20-30 minutes each call. Group session sizes may range from 8-15 participants.
16157052|NCT01725672|Drug|Metformin, 1000 mg extended release tablet|In Part A and Part B of the study, Metformin 1000 mg XR tablet will be administered with 240mL water; 125 mL of LUCOZADE was administered every 30 mins for 4 hours after dosing.
16157454|NCT01722552|Behavioral|adherence feedback|
16157023|NCT01725932|Behavioral|Culturally adapted CBT based Self Help|Intervention was based on our initial work using mixed methods, using mixed methods,in Pakistan. It focused on psycho-education, symptoms management, changing negative thinking, behavioral activation, problem solving, improving relationships and communication skills. One person from the family was involved in all cases. The intervention consists of 7 chapters. Manual can be used by the patient's or carers with at least 5 years of education. A member of the research team called them once every week to remind them of the next chapter and also to discuss any issues o problems that emerged during the previous week. This manual can be downloaded from PACT website (http://www.pactorganization.com/)
16157024|NCT01725919|Behavioral|CI therapy|constraint induced movement therapy
16157025|NCT01725906|Drug|empirical therapy|"Nexium (esomeprazole), 40mg, bid, 14 days, plus
~Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus
~Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs
~Select either one of the drugs according to medication history Cravit (levofloxacin) , 250 mg, bid, D8-14 Klaricid (clarithromycin), 500 mg, bid , D8-14 Tetracycline, 500 mg, bid, D8-14"
16157026|NCT01725906|Drug|Genotypic resistance guided therapy|"Nexium (esomeprazole), 40mg, bid, 14 days, plus
~Amoxicillin (Amoxicillin Trihydrate), 1gm, bid, 7 days, plus
~Flagyl (metronidazole), 500mg, bid, 7 days, plus either one of the following drugs
~Select either one of the drugs according to genotypic resistance results Cravit (levofloxacin) , 250 mg, bid, D8-14 Klaricid (clarithromycin), 500 mg, bid , D8-14 Tetracycline, 500 mg, bid, D8-14"
16157027|NCT01725880|Other|Observation|
16157028|NCT01725867|Other|PT program|manual myofascial release for craniomandibular system for 30~40 minutes chin-in exercise within 10 minutes and as home exercise self-care education twice per week for 8 weeks
16157029|NCT01725867|Device|oral appliance|custom-made oral appliance: wear every night for 8 weeks, occasional drop is allowed self-care education
16157030|NCT01725854|Behavioral|Relaxation Response training|Behavioral Relaxation Response Training (Benson-Henry Institute Relaxation Response Training) Participants randomized to the intervention group will participate in the six weekly RR sessions. Examples of in-group skill building exercises are mini relaxations, diaphragmatic breathing, introduction to imagery, and eliciting RR through Yoga. Presentations topics include Introduction to Mind/Body Medicine, Introduction to the RR, Experiential RR Sessions, and Introduction to Cognitive Restructuring. Home skill building assignments include relaxation focus practice, an appreciation journal, self-monitoring with Biodots (biosensor technology that helps participants to monitor and regulate their psycho-emotional state), physical activity, balanced nutrition, and progress notes.
16157031|NCT01725828|Device|Ultrasound|Using the Ultrasound to determine the location of the CTM.
16157032|NCT01725828|Other|External Palpation|Using External Palpation to identify cricothyoid membrane
16157033|NCT01725815|Behavioral|HARP Intervention|The HARP intervention is a 6-week, 6-session, group format intervention to improve self-management of chronic medical diseases. Each group lasts 90 minutes and has 8-12 attendees. Between groups, participants work with partners from the group to troubleshoot problems and accomplish action plans identified during the session. At the end of the program, monthly alumni groups meet for six months to reinforce lessons from the intervention, monitor progress, and maintain peer support.
16157034|NCT01725802|Drug|levodopa and carbidopa solution for SC administration|
16157035|NCT01725802|Drug|Placebo|
16157036|NCT01725789|Drug|Ferinject®|"Ferinject®to be administered as IV drip infusion or undiluted bolus injection with a minimum administration time of 15minutes (for 1000mg single administration) for body weight ≥50 Kg or 6 minutes (for 500mg single administration) for body weight <50Kg .
~Note, Ferinject® should be administered to a maximum of 20mg iron/kg. Therefore in patients with a body weight <50kg, administration of Ferinject® should be limited to 500mg at baseline . All patients with a serum ferritin value <15ng/mL and Hb<10g/dl at week 3 visit that a second dose (of 500mg iron or equivalent placebo) will be given.(Study group: Ferinject®500mg, Control Group:Placebo)"
16157037|NCT01725789|Drug|normal saline|Placebo will be in the form of normal saline administered over same time period as equivalent Ferinject® administration. IV drip infusion or undiluted bolus injection with a minimum administration time of 15 minutes (200mL as infusion or 20mL as bolus injection) for body weight ≥50 Kg or 6 minutes (100mL normal as infusion or 10mL as bolus injection) for body weight <50 Kg.
16157038|NCT01725776|Drug|Inhaled milrinone 5 mg|Inhaled milrinone 5 mg (as for the injectable solution)
16157039|NCT01725763|Other|Cardiac MRI|
16157040|NCT01725750|Device|Bright White Light (BWL)|"Participants will self-administer bright white light daily. Litebooks used for Bright White Light and Dim Red Light are identical except for the light which they emit. Users are instructed to place it about 18 from their face and within 45º of the visual field for 30 minutes within half an hour of waking each morning, for 4 weeks. The participant may eat, read, watch TV, etc. while sitting in front of the box."
16157041|NCT01725750|Device|Dim Red Light (DRL)|"A device that appears identical to BWL Litebook but that uses red LEDs emitting DRL. Users are instructed to place it about 18 from their face and within 45º of the visual field for 30 minutes within half an hour of waking each morning, for 4 weeks. The participant may eat, read, watch TV, etc. while sitting in front of the box."
16157042|NCT01725737|Drug|GlyTI-M|
16157043|NCT01725737|Drug|Placebo|Placebo Comparator: starch
16157044|NCT01725724|Procedure|Autologous blood transfusion|Per- and postoperative transfusion of autologous salvaged blood collected with the Sangvia Blood Collection System.
16157045|NCT01725724|Procedure|Allogeneic blood transfusion|Transfusion of allogeneic blood according to the transfusion guidelines at each of the participating hospitals.
16157046|NCT01725711|Device|OPRA Implant System|
16157047|NCT01725698|Drug|Mesenchymal stem cell, HA-CaSO4, ¬BMP-2, and Implant|
16157048|NCT01725685|Drug|FF 400 mcg|FF will be available as 100 mcg strength administered as 4 inhalations from a DPI
16157049|NCT01725685|Drug|UMEC 500 mcg|UMEC will be available as 125 mcg strength administered as 4 inhalations from a DPI
16157050|NCT01725685|Drug|FF/UMEC 400/500 mcg|FF/UMEC will be available as 100/125 mcg strength administered as 4 inhalations from a DPI
16157051|NCT01725672|Drug|Metformin, 500 mg extended release tablet|In Part A and Part B of the study, Metformin 500 mg XR tablet will be administered with 240 millilitre (mL) water ; 125 mL of LUCOZADE was administered every 30 mins for 4 hours after dosing.
16157092|NCT01725451|Drug|Testosterone|Administered topically to axillae
16157093|NCT01725451|Other|Deodorant Spray|Administered topically to axillae
16157053|NCT01725672|Drug|Glimepiride, 1 mg immediate release tablet|In Part A and Part B of the study, Glimepiride 1 mg IR tablet will be administered with 240mL water; 125 mL of LUCOZADE was administered every 30 mins for 4 hours after dosing.
16157054|NCT01725672|Drug|Glimepiride, 2 mg immediate release tablet|In Part A and Part B of the study, Glimepiride 2 mg IR tablet will be administered with 240mL water; 125 mL of LUCOZADE was administered every 30 mins for 4 hours after dosing.
16157055|NCT01725672|Drug|Metformin, 500 mg and Glimepiride, 1 mg extended release film coated tablet containing release controlling polymers|In Part A of the study, 1 XR film coated tablet combination of Metformin 500 mg and Glimepiride 1 mg will be administered with 240 mL water; 125 mL of LUCOZADE was administered every 30 mins for 4 hours after dosing.
16157056|NCT01725672|Drug|Metformin, 1000 mg and Glimepiride, 2 mg extended release film coated tablet containing release controlling polymers|In Part A of the study, 1 XR film coated tablet combination of Metformin 1000 mg and Glimepiride 2 mg will be administered with 240 mL water; 125 mL of LUCOZADE was administered every 30 mins for 4 hours after dosing.
16157057|NCT01725672|Drug|Metformin, 500 mg and Glimepiride, 1 mg extended release tablet coated with release controlling polymers|In Part B of the study, 1 XR tablet combination of Metformin 500 mg and Glimepiride 1 mg will be administered with 240 mL water; 125 mL of LUCOZADE was administered every 30 mins for 4 hours after dosing.
16157058|NCT01725672|Drug|Metformin, 1000 mg and Glimepiride, 2 mg extended release tablet coated with release controlling polymers|In Part B of the study, 1 XR tablet combination of Metformin 1000 mg and Glimepiride 2 mg will be administered with 240 mL water; 125 mL of LUCOZADE was administered every 30 mins for 4 hours after dosing.
16157059|NCT01725659|Other|Motor Learning|training of the hemiplegic upper limb with motor learning
16157060|NCT01725659|Other|Robotics|subjects perform training of hemiplegic arm using an upper extremity robot
16157061|NCT01725659|Other|surface FES|subjects are provided with surface FES to the hemiplegic upper limb
16157062|NCT01725646|Drug|Omacor®|Subjects in 4 g and 2 g Omacor® will take this drug
16157063|NCT01725646|Drug|Placebo|Subjects in placebo group will take this drug
16157064|NCT01725633|Behavioral|Progressive Stretching Group|Participants assigned to the progressive stretching group will be provided with a progressive stretching program that matches the aerobic training interventions in terms of program length (16 weeks), social interaction (all sessions will be supervised), and session duration (20-45 minutes/session, ± 10 minutes).
16157065|NCT01725633|Behavioral|Nonlinear Aerobic Training|Participants assigned to the nonlinear aerobic training arm will perform no more than 150 minutes per week of structured supervised aerobic training as part of clinical trial participation. Exercise performed outside the structured sessions (i.e., contamination) will be assessed via self-report of exercise behavior using the Godin-Leisure Time Exercise Questionnaire (GLTEQ). For ethical reasons, we will not instruct participants not to exercise outside the structured sessions, but we we will encourage participants to maintain their level of exercise behavior prior to study initiation.
16157066|NCT01725633|Other|Blood draw|At Weeks 4, and 8, all participants will have a complete blood count (CBC) test performed.
16157067|NCT01725633|Other|Cardiopulmonary Exercise Testing (CPET)|At the end of Week 6, participants repeat the CPET in the nonlinear aerobic training group.
16157068|NCT01725620|Drug|LBEC0101 (Etanercept 25mg)|
16157069|NCT01725620|Drug|Enbrel (Etanercept 25mg)|
16157070|NCT01725607|Drug|general anesthesia combined with dexmedetomidine infusion|general anesthesia combined with 1 μg/kg dexmedetomidine infusion after induction (Group D)
16157071|NCT01725607|Procedure|general anesthesia combined with TEA|general anesthesia combined with TEA (Group E)
16157072|NCT01725594|Drug|CAT 2003|
16157073|NCT01725594|Drug|Placebo|
16157074|NCT01725581|Procedure|Observed Structured Assessment Tool in Pelvic Examination|Participants will be asked to perform a pelvic examination including a speculum and bimanual examination on a pelvic model. They will be asked to approach the pelvic model as if it were a real patient.
16157075|NCT01725568|Device|BioMonitor|Implantable cardiac monitor
16157076|NCT01725555|Drug|Fasted treatment: AXL1717|
16157077|NCT01725555|Drug|Fed treatment: AXL1717|
16157078|NCT01725542|Drug|Asunaprevir, Daclatasvir, Ribavirin and Peginterferon alfa-2a|
16157079|NCT01725529|Drug|TMC435|TMC435 100 mg or 150 mg capsules taken orally (by mouth) with food once-daily for 12 weeks (Week 12).
16157080|NCT01725529|Drug|Peginterferon-alpha (PegIFNα-2a)|PegIFNα-2a (180 micrograms [μg] once weekly) administered as weekly subcutaneous (s.c.) (under the skin) injections of 0.5 mL for 24 or 48 weeks.
16157081|NCT01725529|Drug|Ribavirin (RBV)|Ribavirin 1000 or 1200 mg/day (taken as 100 mg or 200 mg tablets) depending on body weight (If body weight is < 75 kg the total daily dose of RBV will be 1000 mg, administered as 400 mg intake with food in the morning and 600 mg intake with food in the evening. If body weight is > or = 75 kg the total daily dose will be 1200 mg, administered as 2 x 600 mg per intake with food, morning and evening) for 24 or 48 weeks.
16157082|NCT01725529|Drug|Placebo|Matching placebo capsules taken orally with food once-daily for 48 weeks.
16157083|NCT01725516|Procedure|Myofascial release technique|
16157084|NCT01725503|Dietary Supplement|Creatine and Amino Acid supplement|
16157085|NCT01725490|Drug|Metformin|Patients will be randomly assigned in a 2:2:1 ratio to receive metformin or identical-appearing placebo tablets orally for 7 months: metformin 500mg once and placebo twice a day in arm A, metformin 500mg three times a day in arm B, and placebo three times a day in arm C.
16157086|NCT01725490|Drug|Metformin|Patients will be randomly assigned in a 2:2:1 ratio to receive metformin or identical-appearing placebo tablets orally for 7 months: metformin 500mg once and placebo twice a day in arm A, metformin 500mg three times a day in arm B, and placebo three times a day in arm C.
16157087|NCT01725490|Drug|Placebo|Patients will be randomly assigned in a 2:2:1 ratio to receive metformin or identical-appearing placebo tablets orally for 7 months: metformin 500mg once and placebo twice a day in arm A, metformin 500mg three times a day in arm B, and placebo three times a day in arm C.
16157088|NCT01725477|Drug|methylen blue &normal saline|Washing after dye injection
16157089|NCT01725477|Drug|methylene blue|
16157090|NCT01725477|Drug|metheylne blue with normal saline|
16157091|NCT01725464|Device|oxygen cannular|Patient receives oxygen supplementation 5 LPM via oxygen cannular for 120 minutes after the operative
16157605|NCT01721434|Drug|Levosimendan|
16157094|NCT01725451|Other|Deodorant and Antiperspirant Combination Spray|Administered topically to axillae
16157095|NCT01725451|Other|Deodorant and Antiperspirant Combination Stick|Administered topically to axillae
16157096|NCT01725438|Other|sample blood|
16157097|NCT01725425|Other|Control|The control is designed to determine average mood.
16157098|NCT01725425|Other|Increase Portion Size|The purpose is to determine whether a change in mood will occur.
16157099|NCT01725425|Other|Decrease Portion Size|The purpose is to determine whether a change in mood will occur.
16157100|NCT01725425|Other|Mixed Portions|The purpose is to determine if a change in mood will occur.
16157101|NCT01725412|Dietary Supplement|Thiamine 300mg PO once daily|
16157102|NCT01725412|Dietary Supplement|placebo|
16157103|NCT01725399|Other|Apple Juice|
16157104|NCT01725399|Other|Water|
16157105|NCT01725386|Drug|Capecitabine|Oral tablet(s) administered according to prescribing information
16157106|NCT01725360|Drug|montelukast|Adding montelukas to a preexisting treatment with inhaled corticosteroid and long-acting betamimetic in patients with well-controlled asthma.
16157107|NCT01725334|Procedure|Deep Brain Stimulation|Deep Brain Stimulation (DBS) is a surgical procedure involving the implantation of a thin flexible wire called a lead. This device sends mild electric signals to an area of the brain. This study targets two different areas that we believe may be responsible for negative symptoms observed in patients with schizophrenia. There are two stages to DBS: (1) Insertion of the DBS electrodes (2) The connection of these electrodes to a battery under the collarbone.
16157108|NCT01725321|Other|Narrow band imaging|Colonoscopy with new narrow band imaging
16157109|NCT01725308|Drug|FK949E|Taken by mouth (orally).
16157110|NCT01725308|Drug|Placebo|Taken by mouth (orally).
16157111|NCT01725295|Other|NST|A form of physical therapy
16157112|NCT01725295|Other|Hydrotherapy|
16157113|NCT01725282|Drug|quetiapine extended release (XR)|Extended release tablets
16157114|NCT01725282|Drug|Placebo|matching tablets
16157115|NCT01725269|Drug|AIR001|All doses specified are the amount loaded into the I-neb AAD System nebulizer.
16157116|NCT01725256|Drug|AIR001 (sodium nitrite inhalation solution)|Dose arms specify dose loaded into the I-neb AAD System nebulizer
16157117|NCT01725243|Drug|Carbetocin|Carbetocin IV, over 1 minute following delivery. Doses: 10, 20, 40, 60, 80, 100, 120 or 140mcg
16157118|NCT01725230|Drug|Fostamatinib|100-mg tablet
16157119|NCT01725230|Drug|Rosuvastatin|20-mg tablet
16157120|NCT01725230|Drug|Simvastatin|40-mg tablet
16157121|NCT01725217|Biological|MenACWY-CRM|1 vaccination at visit 1, conjugate vaccine, Intramuscular (IM) injection
16157122|NCT01725204|Drug|Dasatinib + PegIFN|
16157123|NCT01725191|Other|Laboratory Biomarker Analysis|Correlative studies
16157124|NCT01725191|Other|Pharmacological Study|Correlative studies
16157125|NCT01725191|Drug|Tivantinib|Given PO
16157126|NCT01725178|Behavioral|Cognitive and Physical training|"Physical training - Three 60-minute session per week. Participants will be divided in groups of 10, supervised by physiotherapists. Physical activity combines aerobic exercises, muscle strengthening, balance improvement, joint flexibility. Once a week the session is replaced by outdoor walking; once a month by dancing.
~Cognitive training - The program alternates focuses on specific functions and recreational sessions. Each session will be followed by a lesson about cognitive processes (memory, learning, attention, thought), providing tips to overcome difficulties in daily life. Sessions will focus on attention, imagination, spatial memory, categorization; memory for terms, meanings, songs, faces, names; memorization of texts; goal management."
16157127|NCT01725165|Other|Clinical Observation|Undergo clinical observation
16157128|NCT01725165|Radiation|External Beam Radiation Therapy|Undergo EBRT
16157129|NCT01725165|Other|Laboratory Biomarker Analysis|Optional correlative studies
16157130|NCT01725165|Other|Quality-of-Life Assessment|Ancillary studies
16157131|NCT01725165|Procedure|Standard Follow-Up Care|Undergo standard maintenance therapy
16157132|NCT01725165|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16157133|NCT01725152|Drug|Ganaxolone|oral suspension, given in 3 divided doses
16157134|NCT01725152|Drug|Placebo|oral suspension, given in 3 divided doses
16157135|NCT01725139|Drug|GSK2126458|GSK2126458 will be available as film coated tablet of dose strength 0.25 mg and 0.5 mg
16157136|NCT01725139|Drug|Placebo|Matching placebo will be available
16157137|NCT01725126|Drug|GSK2890457|Provided as powder and capsule.
16157138|NCT01725126|Drug|Metformin|"Tablet
~Part A: Single doses on Day 1 and Day 42 orally
~Part B: Subject continues usual metformin dose through Run-in, and resumes after Treatment Period completed
~Part C: Subject continues usual metformin dose throughout study"
16157139|NCT01725126|Drug|Placebo|Provided as powder and Capsule.
16157140|NCT01725126|Drug|Liraglutide|"Provided as Injection. 6mg/mL, 3mL injector pen that permits doses of 0.6mg, 1.2mg, and 1.8mg
~Subcutaneous injection 18 weeks dosing (Stabilization and Treatment Periods, Part B only"
16157141|NCT01725113|Drug|Calcitriol|3 times weekly
16157142|NCT01725113|Drug|Paricalcitol|3 times weekly
16157143|NCT01725100|Drug|GSK1120212B (Standard DMSO content)|Each tablet contains GSK1120212B equivalent to 2 mg of GSK1120212 as drug substance. The coated tablets have a standard DMSO content of theoretical 11.3%.
16157144|NCT01725100|Drug|GSK1120212B (Lower DMSO content)|Each tablet contains GSK1120212B equivalent to 2 mg of GSK1120212 as drug substance. The coated tablets have a lower DMSO content approximately 9.5%.
16157145|NCT01725087|Drug|Matching Placebo|
16157146|NCT01725087|Drug|Low Dose GRT6005|
16157147|NCT01725087|Drug|Medium Dose GRT6005|
16157148|NCT01725087|Drug|High Dose GRT6005|
16157149|NCT01725087|Drug|Tapentadol|
16157192|NCT01724723|Drug|entecavir (BARACLUDE®)|entecavir 0.5 mg per day during and within 6 months after anti-tuberculous treatment
16157193|NCT01724697|Other|BMSC transplantation|Patients randomized to the intervention arm will be collected for bone marrow stem cells and then infused with these cells via hepatic artery.
16157194|NCT01724697|Other|conventional treatment & antivrial treatment|Participants will recieve conventional treatment and antivrial treatment.
16157195|NCT01724684|Other|Telehealth program|
16157150|NCT01725074|Behavioral|"Case Management CM CHD"|"Patients, who are randomized to the intervention group, will receive case management from a trained and experienced physician assistant. The case manager will carry out following tasks:
~Biweekly/monthly telephone consultations or home visits
~Identification of health or personal problems of the patient
~Monitoring of medical parameters
~Coordination of contact with health care providers if necessary
~Support to the patient related to health status and environmental changes
~Promote disease-self management through coaching
~Counseling, that is focused on emotional support and active listening"
16157151|NCT01725074|Behavioral|Social Interaction|Identical as the CM CHD group, but with exclusion of medical control measures and the medical aspects.
16157152|NCT01725048|Drug|Mirtazapine|7.5mg by mouth once a day at night. If subject has not had a 50% or greater reduction in the PHQ-9 depression assessment score, and if the subject is not experiencing unacceptable adverse effects, then the dose may be escalated first to 15mg by mouth every night and then to 30mg by mouth every night.
16157153|NCT01725048|Drug|Citalopram|Citalopram 10mg by mouth once daily. If the subject has not had a 50% or greater reduction in PHQ-9 depression assessment score, and if the subject is not experiencing unacceptable side effects, then the dose may be escalated first to 20mg by mouth every day and then to 40mg by mouth once a day.
16157154|NCT01725022|Other|Home Care|This is the interventional arm where patients receive the transplant care in their homes.
16157155|NCT01725009|Drug|Multiple 15-minute intravenous infusions of 1500 mg levetiracetam|Strength, 100 mg/mL; Form, concentrate for solution for infusion; Frequency, twice a day; Duration, 7 days
16157156|NCT01724996|Other|Clinical examination: chest wall tenderness|The physical examination includes the testing of chest wall tenderness: Palpation of chest wall tenderness in lying 30° elevation of chest position. Flat index with standardized pressure where spontaneous maximum pain is reported (reproducible vs. not reproducible pain vs. no pain). Negative control (right side of chest mid-clavicle intercostal 6/7), reproducible vs. not reproducible pain vs. no pain.
16157157|NCT01724983|Drug|ketamine|
16157158|NCT01724983|Drug|fentanyl|
16157159|NCT01724970|Device|ProSeal|Patients will be ventilated with PLMA
16157160|NCT01724970|Device|Supreme LMA|Patients will be ventilated with SLMA
16157161|NCT01724957|Procedure|Intracoronary ECG|Recording of icECG from the tip of PCI guidewire. The wire end is connected through alligator clips to V-lead from surface ECG
16157162|NCT01724944|Procedure|Systematic pelvic and aortic lymphadenectomy|Pelvic lymphadenectomy dissection began at the origin of the external iliac vessels and continued caudally along the medial border of the psoas muscle, with the lower limit of the external iliac lymphadenectomy being represented by the deep inferior epigastric vessels. The lateral boundaries of lymphadenectomy were delineated superficially by the fascia covering the psoas muscle and deeply by the fascia covering the internal obturator and levator ani muscles. Lymph nodes along the external iliac vessels were removed en bloc with those adjacent to the common iliac vessels. Aortic lymphadenectomy dissection began at the aortic bifurcation by removing the superficial intercavoaortic, precaval, and preaortic nodal groups. Lymph nodes located lateral to the vena (i.e., paracaval nodal group) were separated from the vena cava, then removed en bloc. Lymph nodes behind the vena cava are removed if enlarged. Removal of the lateroaortic nodes was performed up to the level of the left renal vein.
16157163|NCT01724931|Drug|LD-aminopterin|
16157164|NCT01724931|Drug|placebo|
16157165|NCT01724918|Drug|Lacosamide|
16157166|NCT01724905|Dietary Supplement|Modified Stop Light Diet (SLDm)|SLDm includes reduced energy pre-packaged meals (PM) for 6 months, encouraged consumption of low energy shakes and 35 fruits and vegetables (F/V) per week
16157167|NCT01724905|Dietary Supplement|Recommended Care Diet|RC diet includes traditional meal plans and 35 fruits and vegetables per week
16157168|NCT01724892|Drug|Dexamethasone|
16157169|NCT01724892|Drug|Loteprednol etabonate|
16157170|NCT01724879|Drug|Dasatinib|Dasatinib p.o. + Chemotherapy (Dexamethasone, Cyclophosphamide, Vincristine, Methotroxate, 6-Mercapto-Purine, Cytarabine, Vindesine, VP16 (Etoposide))
16157171|NCT01724866|Drug|HM10460A (45 μg/kg)|Single-dose subcutaneous injection
16157172|NCT01724866|Drug|HM10460A (135 μg/kg)|Single-dose subcutaneous injection
16157173|NCT01724866|Drug|HM10460A (270 μg/kg)|Single-dose subcutaneous injection
16157174|NCT01724866|Drug|Pegfilgrastim 6mg|Single-dose subcutaneous injection, per manufacturer's Prescribing Information
16157175|NCT01724866|Drug|Docetaxel|Standard therapy
16157176|NCT01724866|Drug|Cyclophosphamide|standard therapy
16157177|NCT01724853|Procedure|Surgery|Resection suspension interposition arthroplasty or Arthrodesis
16157178|NCT01724853|Other|Conservative|Injection
16157179|NCT01724840|Procedure|GraftJacket|Interposition with GraftJacket
16157180|NCT01724840|Procedure|Tendon Interposition|Tendon Interposition with the FCR tendon
16157181|NCT01724827|Device|ceramic (Empress CAD, Ivoclar Vivadent)|Leucite-reinforced glass ceramic (Empress CAD, Ivoclar Vivadent)
16157182|NCT01724827|Device|composite (Lava Ultimate, 3M Espe)|Nanohybrid composite resin (Lava Ultimate, 3M Espe)
16157183|NCT01724814|Drug|HM12460A|Single dose SC administration ranging from 1.2 nmol/kg to 19.2 nmol/kg of HM12460A
16157184|NCT01724814|Drug|Placebo|Singe dose SC administration of Placebo
16157185|NCT01724801|Radiation|whole brain radiation(WBI)|WBI (30Gy/3Gy/10 fractions) plus concurrent or sequential chemotherapy for 4-6 cycles
16157186|NCT01724801|Drug|Icotinib|administered orally at a dose of 125 mg 3 times daily
16157187|NCT01724788|Drug|FUROSEMIDE|Pharmaceutical form: Solution Route of administration: Intravenous
16157188|NCT01724788|Drug|FUROSEMIDE (HOE058)|Pharmaceutical form: Tablet Route of administration: Oral
16157189|NCT01724762|Other|Nursing Orientation|"Control group: patients who did not read the informative manual concerning bed bath and received only the unit's routine information
~Intervention group: patients who received nursing orientation and read the informative manual concerning bed bath"
16157190|NCT01724736|Drug|Placebo|Celluose 10g - Matches the total dietary fiber content of NM504 as well as the color and taste. Subjects take 1 dose within 1h prior to either breakfast or lunch and a 2nd dose within 1h prior to the evening meal for 4 weeks.
16157191|NCT01724736|Drug|NM504:|Cobiotic formula of GRAS ingredients with a total dietary fiber content of 10g. Subjects take 1 dose within 1h prior to either breakfast or lunch and a 2nd dose within 1h prior to the evening meal for 4 weeks.
16157197|NCT01724658|Drug|Testosterone undecanoate|testosterone undecanoate 40 mg orally twice a week
16157198|NCT01724658|Drug|placebo|placebo orally twice a week with progynova 1 mg oral daily
16157199|NCT01724645|Dietary Supplement|Korean traditional diets|"The consumption of Korean traditional diets reflecting the characteristics of Korean traditional diets without the limitation of calories has an effect on control of cardiovascular risk factor, so this study instructed all subjects of the intervention group to consume about 2,100kcal of served meals freely.
~The Korean Traditional diets, which encourages the intake of cooked rice, vegetables,soup,Kimchi and soy fermented foods."
16157200|NCT01724645|Dietary Supplement|Control group|"Told to  eat as usal diets."
16157201|NCT01724632|Behavioral|Lifestyle Counseling|Participants receive instructions for making healthy changes to their diet and physical activity habits.
16157202|NCT01724619|Drug|[F-18] fluorinated dihydrotestosterone (FDHT)|
16157206|NCT01724567|Other|Interval Training|Interval training (IT) on an exercise bike 3 times a week, for the first 12 weeks, followed by 40 weeks of IT 2 times a week on exercise bike. Each training session consists of active intervals with a total duration of 16 minutes (durations intervals between 1 and 4 minutes) at 90% of maximal heart rate. Active intervals are separated by active pauses at 60% of maximal heart rate.
16157207|NCT01724567|Other|Weight Loss|Low calorie diet approx. 1000 kcal/day for 8 - 10 weeks to obtain a 10 - 15 % weight loss.
16157208|NCT01724554|Drug|Intravitreal Aflibercept Injection|Aflibercept administered to the eye intravitreally either every month or every other month.
16157209|NCT01724528|Drug|Febuxostat|Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion)
16157210|NCT01724528|Drug|Allopurinol|Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)
16157211|NCT01724515|Other|Lipid infusion and muscle biopsies|Subjects will undergo a baseline muscle biopsy, a lipid infusion for 5 hours (60 ml/hr), and a muscle biopsy after the lipid infusion.
16157212|NCT01724502|Behavioral|Exercise and muscle biopsies|Subjects will undergo a euglycemic clamp, VO_2 max determination, exercise periods and muscle biopsies.
16157213|NCT01724489|Drug|Growth hormone|
16157214|NCT01724489|Drug|Placebo|
16157215|NCT01724476|Drug|folate with B12|
16157216|NCT01724476|Drug|placebo|
16157217|NCT01724463|Other|Severe Sepsis Management Bundle|"Management Bundle includes:
~Securing Intravenous Access
~Obtaining Blood Culture
~Antibiotic Administration
~Goal Directed Fluid Bolus Therapy
~Oxygen Administration
~Measuring Serum Lactate Levels"
16157218|NCT01724450|Drug|Carvedilol|50mg/day for 24 weeks. The dose of carvedilol will be up titrate before the dose of 50mg/day
16157219|NCT01724450|Drug|Placebo|Placebo similar to the carvedilol up titration but wit no active drug.
16157220|NCT01724437|Device|catheter based pulmonary vein isolation|catheter based ablation using irrigated catheters and radiofrequency energy as in clinical practice
16157221|NCT01724424|Drug|Melatonin|20 mg oral single dose
16157222|NCT01724424|Drug|Melatonin|30 mg oral single dose
16157223|NCT01724424|Drug|Melatonin|50mg oral single dose
16157224|NCT01724424|Drug|Melatonin|100mg oral single dose
16157225|NCT01724411|Other|Resistant Starch type 3|Resistant Starch 3: 26g/day males for 11 days, 22 g/day females for 11 days
16157226|NCT01724398|Other|Conventional plus UC-MSC treatment|Received conventional treatment and umbilical cord mesenchymal stem cells transplantation by peripheral vein slowly for 30minutes. (1×105/Kg, once a week, 4 times).
16157227|NCT01724398|Other|Conventional plus PE treatment|Received conventional treatment plus 2000 milliliter plasma exchange (every 3 days, 3 times).
16157228|NCT01724398|Other|Conventional plus UC-MSC and PE therapy|Received conventional treatment plus 2000 milliliter plasma exchange (every 3 days, 3 times). Meantime taken i.v umbilical cord mesenchymal stem cells transplantation slowly for 30minutes (1×105/Kg, once a week, 4 times), the first two times is taken after plasma exchange.
16157229|NCT01724398|Other|Conventional treatment|Received conventional treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
16157230|NCT01724385|Drug|intravitreal injection of bevacizumab|intravitreal injection of bevacizumab
16157231|NCT01724372|Drug|Antidepressant|
16157232|NCT01724372|Drug|Antipsychotic|
16157233|NCT01724359|Drug|Paliperidone ER|The recommended Paliperidone extended-release (ER) dose will be 6 mg/day. Some patients may benefit from higher or lower doses, in the range of 3 to 12 mg/day. Paliperidone ER will be administered orally once daily. Adjustment of the dosage will be done at the investigator's discretion.
16157234|NCT01724346|Drug|Post-Chlorambucil Therapy Follow-up|Patients remain in this Arm for continued follow-up until PD, unacceptable toxicity, or other reason for treatment discontinuation. All patients in this Arm have completed Chlorambucil therapy. Patients who have progression will exit the study.
16157235|NCT01724346|Drug|Ibrutinib|Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily.
16157236|NCT01724346|Drug|Second-line Ibrutinib|Patients in this arm who were previously eligible to receive Second-line Ibrutinib will exit the study with option to roll-over to another long-term Ibrutinib study, if eligible.
16157237|NCT01724346|Drug|Alternative Anticancer Treatment|Specific therapy and treatment regimen are at the Investigator's discretion.
16157238|NCT01724346|Drug|Alternative Anti-cancer Treatment|Specific therapy and treatment regimen are at the Investigator's discretion. Patients originally randomized to Chlorambucil will exit the study. Patients originally randomized to Ibrutinib will continue on study.
16157239|NCT01724320|Drug|OTX008|OTX008 given daily without interruption, subcutaneously. Starting dose: 65 mg/day
16157240|NCT01724307|Procedure|Neurostimulation of stellate ganglion|An electrical nuerostimulation of the stellate ganglion up to 60 minutes
16157241|NCT01724281|Other|No intervention, only follow up|
16157242|NCT01724268|Drug|Pred + Meth|PREDNISOLONE 10mg orally ONCE DAILY and Methotrexate 25 mg / day
16157243|NCT01724268|Drug|Anti TNF + Meth|
16157244|NCT01724255|Other|questionnaire|
16157245|NCT01724242|Drug|Vaginal DHEA|
16157246|NCT01724242|Drug|Placebo|
16157247|NCT01724229|Drug|Kendall Body Wash & Shampoo; Moisture Barrier Cream; 2-in-1 Cleanser; Antifungal Cream|
16157248|NCT01724216|Device|pulse sequences|Collect in vivo human data to demonstrate neurological Magnetic Resonance Imaging of subjects using a pulse sequence
16157249|NCT01724203|Dietary Supplement|Lactobacillus rhamnosus|
16157250|NCT01724203|Dietary Supplement|Bifidobacterium animalis subsp. lactis|
16157251|NCT01724203|Dietary Supplement|Placebo|
16157252|NCT01724190|Drug|Vitamin D|
16157253|NCT01724190|Drug|Placebo|
16157254|NCT01724177|Drug|Lenalidomide|25 mg of Lenalidomide administered orally once daily
16157255|NCT01724164|Behavioral|Mirror Therapy|This protocol includes 1 hour mirror therapy and 0.5 hour functional training in a session. The treatment intensity is 1.5 hours/day, 5 days/week, for 4 weeks. MT focuses on symmetrical bimanual movements and simultaneously observing the mirror visual feedback reflected by the unaffected upper extremity.
16157256|NCT01724164|Behavioral|Robotic assisted therapy|This protocol includes 5 to 10 min of warm-up, 1 hr of RR, and 15 to 20 min of functional activities training. The treatment intensity is 1.5 hours/day, 5days/week for 4 consecutive weeks. The RR session uses the robot-assisted arm trainer, Bi-Manu-Track (Reha-Stim Co., Berlin, Germany).
16157257|NCT01724164|Behavioral|Robotic Rehabilitation with PI|The RR-PI protocol is the same as the RR-FES protocol described above except that the surface electrodes are attached to the same target muscles on the affected upper limb but there is no output of electrical stimulation.
16157258|NCT01724164|Behavioral|Robotic rehabilitation with FES|This combined RR-FES treatment involves the same protocol as the RR regimen except that patients receive FES concurrently with RR.
16157259|NCT01724164|Behavioral|Conventional Rehabilitation|Participants in this group receive a structured protocol based on occupational therapy such as neuro-developmental techniques and task-oriented approach. The treatment dose is matched to RR and MT groups.
16157260|NCT01724138|Drug|Deferasirox|Patients will start their deferasirox treatment with a dose of 20 mg/kg/day.
16157261|NCT01724125|Other|personal electronic medical record|
16157262|NCT01724112|Drug|LY2940094|Administered orally
16157263|NCT01724112|Drug|Placebo|Administered orally
16157264|NCT01724099|Drug|Euiiyin-tang|Korean medicinal herbal drug
16157265|NCT01724099|Drug|Placebo|Placebo drug, same odor and formula as Euiiyin-tang
16157266|NCT01724086|Drug|TMC647055|Type=exact number, unit=mg, number=150, form=capsule, route=oral. 3 or 4 capsules of 150 mg will be administered once daily.
16157267|NCT01724086|Drug|TMC435|Type=exact number, unit=mg, number=75, form=capsule, route=oral. 1 capsule of 75 mg will be administered once daily.
16157268|NCT01724086|Drug|Ritonavir|Type=exact number, unit=mg, number=30 or 50, form=tablet or solution, route=oral. 0.375 mL or 0.625 ml (80 mg/mL) solution will be administered once daily.
16157269|NCT01724086|Drug|Ribavirin|Type=exact number, unit=mg, number=200, form=tablet, route=oral. 5 to 6 (1000 or 1200 mg) tablets will be administered once daily, divided in 2 daily doses. Patients meeting the Follow-UP (FU) treatment criteria specified in the protocol will receive treatment 5 or 6 (depending on bodyweight) tablets of ribavirin (equivalent to 200 mg/tablet) per day, divided in 2 daily doses for an additional 12 or 36 weeks.
16157270|NCT01724086|Drug|Pegylated interferon alpha-2a (PegIFN)|Type=exact number, unit=mcg, number=180, form=solution, route=subcutaneous injection. PegIFN 0.5 mL prefilled syringe equivalent to 180 mcg will be administered as a subcutaneous (under the skin) injection as follow-up (FU) treatment for 12 or 36 weeks based on follow-up treatment principles as described in the protocol. Patients meeting the Follow-UP (FU) treatment criteria specified in the protocol will receive treatment with Pegylated interferon alpha-2a (PegIFN) 0.5 mL prefilled syringe equivalent to 180 mcg administered as a subcutaneous (under the skin) injection for an additional 12 or 36 weeks.
16157271|NCT01724086|Drug|GSK2336805|Type=exact number, unit=mg, number=30 or 60, form=tablet, route=subcutaneous injection. GSK2336805 one or two 30 mg tablet(s) taken orally (by mouth) once daily for 12 weeks.
16157272|NCT01724073|Dietary Supplement|Leafy vegetable-fish sauce|
16157273|NCT01724073|Dietary Supplement|Leafy vegetable-fish/liver sauce|
16157274|NCT01724073|Dietary Supplement|Misola|
16157275|NCT01724047|Behavioral|Playground Intervention|Intervention is designed for children diagnosed with an autism spectrum disorder (ASD) included in a regular education k through fifth grade classroom for at least 50% of the school day. Schools will be randomized to one of two conditions. The conditions are: 1) Immediate treatment, where the training will begin immediately after baseline measures are completed. 2) Waitlist treatment, where the training will begin the following school year. This study will take place at school. All intervention activities will be conducted during recess or lunch where children with autism may have the most difficulty interacting with peers. A total of 14-16 intervention sessions will be held with the child with autism, school personnel, and the child's classmates. The intervention will last approximately 3 months with a 3-month follow-up.
16157321|NCT01723774|Procedure|Surgery (standard of care)|-Breast and axillary lymph node surgery
16157322|NCT01723774|Procedure|Tumor biopsy|
16157323|NCT01723748|Drug|genotropin|iii) intravenous exogenous bolus of GH (0.5 mg) followed by muscle and fat biopsies.
16157324|NCT01723735|Drug|Alirocumab|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous"
16157325|NCT01723735|Drug|Ezetimibe|"Pharmaceutical form: overencapsulated tablet
~Route of administration: oral"
16157326|NCT01723735|Drug|Ezetimibe Placebo|"Pharmaceutical form: capsule
~Route of administration: oral"
16157276|NCT01724047|Behavioral|STAT Intervention|This study will track the behavioral progress of children whose teachers receive training in these instructional methods. This study also will examine the ability and willingness of teachers to use these methods as they were designed. The study will last approximately 18 weeks (6 weeks of intervention, and a 3 month follow up visit). This study will take place at school. Classrooms will be randomized to one of two conditions. The conditions are: 1) Immediate treatment, where the training will begin immediately after baseline measures are completed. 2) Waitlist treatment, where the training will begin the following school year. All intervention activities will be conducted with a teacher during the school day but not during instructional time. Study staff will visit the school on a weekly basis to train your child's teacher on evidence-based strategies for teaching children with autism.
16157277|NCT01724034|Other|Abolish Lung Sliding|If there is no lung sliding, the patient will be promptly evaluated for pneumothorax or mainstream intubation.
16157278|NCT01724034|Other|Normal Lung Ultrasound|If the patient fails the spontaneous breathing trial and the lung ultrasound examination is normal - researchers will investigate venous thrombosis (deep vein thrombosis and/or pulmonary embolism) and rule out reversible airway obstruction. If the patient has the previous diagnosis of COPD, non invasive mechanical ventilation is indicated for facilitate weaning.
16157279|NCT01724034|Other|Pulmonary Interstitial Syndrome|"If lung ultrasound shows B pattern - cardiogenic pulmonary edema will be differentiated from Acute Respiratory Distress Syndrome (ARDS). If cardiogenic edema is a possibility, diuretics will be administrated (at least 40 mg of furosemide) or ultrafiltration will be performed. The main target is a negative fluid balance of, at least, 1000 ml before the next spontaneous breathing trial. Another possibility is to titrate vasodilators (at least a 20% reduction in the systolic blood pressure) before the next spontaneous breathing trial."
16157280|NCT01724034|Other|Asymmetrical Lung Ultrasound|If lung ultrasound shows asymmetrical findings, the occurence of new or uncontrolled infection (pulmonary or extrapulmonary) will be investigated.
16157281|NCT01724034|Other|Simple Pleural Effusion|If the patient has pleural effusion without ultrasonographic signs of complications (any hyperechoic pattern or complex septated pattern), researchers will administrate diuretics (at least 40 mg of furosemide in 24 hours) or increase ultrafiltration - to achieve a negative fluid balance of, at least, 1000 ml before the next spontaneous breathing trial. Another possibility is to perform pleural drainage.
16157282|NCT01724034|Other|Complex Pleural Effusion|If there is pleural effusion with hyperechoic or septated pattern, another image exam will be performed and evaluated by the surgical team.
16157283|NCT01724021|Drug|Cyclophosphamide, Hydroxydaunorubicin, Oncovin, Prednisone/Prednisolone (CHOP)|Standard chemotherapy
16157284|NCT01724021|Drug|Cyclophosphamide, Vincristine, Prednisone/Prednisolone (CVP)|Standard chemotherapy
16157285|NCT01724021|Drug|Bendamustine|Standard chemotherapy
16157286|NCT01724021|Drug|Rituximab|1400 mg subcutaneously (SC), Day 1 Cycles 2-4
16157287|NCT01724021|Drug|Rituximab|375 mg/m2 IV, Day 1 Cycles 1-4
16157288|NCT01724021|Drug|Rituximab|375 mg/m2 intravenously (IV), Day 1 Cycles 1 and 4-8
16157289|NCT01724021|Drug|Rituximab|1400 mg SC, Day 1 Cycles 5-8
16157290|NCT01723995|Radiation|low-level laser on nipples|The LASER HAND WL device, manufactured by MM Optics.
16157291|NCT01723982|Drug|Barusiban (FE 200440)|
16157292|NCT01723982|Drug|Placebo Comparator|
16157293|NCT01723969|Genetic|Tumour markers testing|Tumour markers testing in patients advanced or metastatic colo-rectal cancer.
16157294|NCT01723956|Procedure|Cryotherapy|This is involves freezing the lesions with a cryo gun using Nitrous Oxide for 3 minutes-- wait 5 minutes and then refreezing for 3 more minutes. This procedure uses the Wallach cryogun
16157295|NCT01723956|Procedure|LEEP|The cervix is anaesthetized with lidocaine and then a electric loop is applied to the cervical lesion which is cut with one pass. The LEEP machine used is the automatic Finesse Machine.
16157296|NCT01723943|Other|educational intervention|"Receive the What's Happening to the Woman I Love? booklet"
16157297|NCT01723943|Other|counseling intervention|Undergo Helping Her Heal educational counseling program
16157298|NCT01723943|Other|educational intervention|Undergo Helping Her Heal educational counseling program
16157299|NCT01723943|Other|psychosocial support for caregiver|Undergo Helping Her Heal educational counseling program
16157300|NCT01723917|Dietary Supplement|PhytoSERM tablet|
16157301|NCT01723917|Dietary Supplement|placebo|
16157302|NCT01723904|Drug|Rotigotine|Application of Rotigotine up to 8 mg/24 h patches for 24 hours.
16157303|NCT01723891|Drug|Surfolase capsule|
16157304|NCT01723891|Drug|HT-002-01|
16157305|NCT01723852|Dietary Supplement|Vitamin D at 30 ug/day|
16157306|NCT01723852|Dietary Supplement|Vitamin D at 10 ug/day|
16157307|NCT01723839|Drug|Fludarabine, Cyclophosphamide, Rituximab, Lenalidomide|19 subjects are treated in stage-1 with FCR plus 5mg lenalidomide increasing to 10mg and 15mg in subsequent cycles depending on toxicity.
16157308|NCT01723826|Drug|Crenezumab|Participants will receive intravenous infusion of crenezumab every 4 weeks for 144 weeks.
16157309|NCT01723813|Biological|Tumor specific peptides: MAGE-3.A1 and / or NA17.A2|Each peptide will be given at a dose of 300 µg in 1 ml of sodium chloride 0.9%, every 3 weeks on 6 occasions, and will be administered at one site in arm or thigh, 20% of the dose intradermally and 80% of the dose subcutaneously.
16157310|NCT01723813|Biological|Galectin-3 inhibitor: GM-CT-01 systemic injections|Systemic injection of GM-CT-01: GM-CT-01 will be administered by slow intravenous infusions at a dose of 280 mg/m2, on days +3, +6, +9, +12, +15, +18 after each of the 3rd, 4th, 5th and 6th vaccination.
16157311|NCT01723813|Biological|Galectin-3 inhibitor: GM-CT-01 Peri-tumoral administration|GM-CT-01 will be injected peri-tumoral at a dose of 100 µg per tumor injected, on days +3, +6, +9, +12, +15, +18 after each of the 3rd, 4th, 5th and 6th vaccination. If a patient has one or two superficial metastases at day 43 of the treatment, one of these lesions will be treated. If a patient has more than two superficial metastases at day 43, two of these lesions will be treated.
16157312|NCT01723800|Drug|PI3K inhibitor BKM120|Given PO
16157313|NCT01723800|Drug|pemetrexed disodium|Given IV
16157314|NCT01723800|Drug|carboplatin|Given IV
16157315|NCT01723800|Other|laboratory biomarker analysis|Correlative studies
16157316|NCT01723800|Other|pharmacological study|Correlative studies
16162345|NCT01685255|Drug|tamoxifen|
16157327|NCT01723735|Drug|Fenofibrate|"Pharmaceutical form: tablet
~Route of administration: oral"
16157328|NCT01723722|Drug|Methadone|Concentration is 1mg/mL administered every 12 hours given on sliding scale in response to last NAS score.
16157329|NCT01723722|Drug|Diluted Deodorized Tincture of Opium|Concentration is 1:24 dilution for a concentration of 0.4%
16157330|NCT01723696|Dietary Supplement|Vitamin C +prenatal vitamin|Pregnant smoking women will be randomized to daily vitamin C (500 mg) versus daily placebo
16157331|NCT01723696|Dietary Supplement|Placebo tablet+prenatal vitamin|
16157332|NCT01723683|Drug|Surfactant|
16157333|NCT01723670|Drug|CHF 5074 1x|oral tablet, 1x, once a day for 24 months
16157334|NCT01723670|Drug|CHF 5074 2x|oral tablet, 2x, once a day for 24 months
16157335|NCT01723670|Drug|Placebo|oral tablet,once a day for 24 months
16157336|NCT01723657|Drug|Ara-C|"Intermediate dose during induction phase to remission.
~High dose during consolidation phase in patients with favorable cytogenetics and leukocyte index below 20."
16157337|NCT01723657|Other|Autologous peripheral blood stem cell transplantation.|"In patients with favorable cytogenetics with a Leukocyte index above 20.
~Patients with normal karyotype, and one cycle of chemotherapy to achieve complete remission, without adverse molecular and/or minimal residual disease (MRD) characteristics, regardless availability of a matched donor."
16157338|NCT01723657|Other|Allogeneic matched related or unrelated donor transplant.|-Patients without favorable/intermediate characteristics.
16157339|NCT01723657|Drug|G-CSF|"Administration at induction phase to remission, days 0 to 7. G-CSF will not be initiated if the leukocyte count is over 30x10e9/L at diagnosis or will be interrupted if the leukocyte count during treatmen arises 30x10e9/L.
~Administration at consolidation phase, days 4 to 6 (3 doses). G-CSF will be interrupted if the leukocyte count during treatment arises 30x10e9/L."
16157340|NCT01723657|Other|CD34+ selection.|-Patients with adverse prognosis with allogeneic peripheral blood stem cell (PBSC)tranplantation, CD34+ cell selection of the inoculum was performed.
16157341|NCT01723657|Other|Mylotarg purging before autologous PBSC transplantation|Patients without favorable/intermediate characteristics and without matched related donor.
16157342|NCT01723644|Other|the clinical reassessment arm|In the clinical reassessment arm, antibiotherapy is systematically started in the emergency department. The continuation, the discontinuation or the modification of the antibiotherapy initially prescribed in the ED were made at Day 1 and Day 5 based on clinical assessment. On Day 1, the aim of the clinical reassessment is diagnosis reassessment: to confirm or not the diagnosis of community-acquired pneumonia and to confirm or not the antibiotherapy. On Day 5, the aim of the clinical reassessment is to evaluate the possibility to stop the current antibiotherapy based on criteria for clinical stability defined by the Infectious Diseases Society of America
16157343|NCT01723644|Other|the procalcitonin arm|In the procalcitonin arm, initiation and discontinuation of the antibiotherapy is based on the antibiotic stewardship based on procalcitonin (PCT) cut-off ranges previously published. Re-evaluation of the clinical status and measurement of serum PCT levels is mandatory after 6-24 h in all persistently sick and hospitalized patients in who antibiotic are withheld. The PCT algorithm can be overruled by pre-specified criteria, e.g. in patients with immediately life-threatening disease. If the algorithm is overruled and antibiotics are given, an early discontinuation of antibiotic therapy after 3, 5 or 7 days is more or less endorsed based on PCT levels. In hospitalized patients with ongoing antibiotic therapy PCT levels are reassessed on days 3, 5 and 7 and antibiotics will be discontinued using the PCT cut-offs defined above.
16157344|NCT01723631|Device|Trap Myelin Test|
16157345|NCT01723618|Drug|CRD007|
16157346|NCT01723605|Procedure|insitu repair|closure of the uterine incision while the uterus initu
16157347|NCT01723605|Procedure|exteriorisation of the uterus|uterine closure while the uterus is exteriorised
16157348|NCT01723592|Dietary Supplement|Probiotics|Probiotics oral probiotic capsules for 7 days twice daily containing four lyophilised Lactobacillus strains,L.rhamnosus/ LbV96 (DSM 22560),L.jensenii /LbV 116 (DSM 22567),L.crispatus/ Lbv88 (DSM 22566),L.gasseri /LbV 150N (DSM 22583)
16157349|NCT01723592|Dietary Supplement|Oral lactose placebo|Placebo
16157350|NCT01723579|Drug|Nomegestrol acetate (NOMAC)|Oral tablet with daily release of 2.5 mg
16157351|NCT01723579|Drug|Estradiol (E2)|Daily release of 1.5 mg
16157352|NCT01723553|Drug|C-11 PiB|One time intravenous administration of ~740 megabecquerel (MBq) of [N-methyl-C-11]2-(4'-methylaminophenyl)-6-hydroxybenzothiazole (PiB) (range 370 - 740 MBq).
16157353|NCT01723540|Procedure|Minilaparotomy vs laparoscopy|MC-group will undergo ultrasonic dissection assisted minilaparotomy cholecystectomy ans patients in the LC-grout will undergo laparoscopic cholecystectomy
16157354|NCT01723527|Drug|Methadone|Clinic-Based Methadone Maintenance Treatment
16157355|NCT01723527|Drug|Buprenorphine|Clinic-Based Buprenorphine Maintenance Treatment
16157356|NCT01723527|Behavioral|Employment-based drug abstinence reinforcement|
16157357|NCT01723514|Drug|Erenumab|Administered by subcutaneous injection once a month
16157358|NCT01723514|Drug|Placebo|Administered by subcutaneous injection once a month
16157359|NCT01723501|Drug|0.25% chlorhexidine|0.44% chlorhexidine di-gluconate body wipes which would release 0.25% free chlorhexidine on application
16157360|NCT01723501|Drug|sterile water|Sterile water wipes (placebo)
16157361|NCT01723488|Radiation|[F18] T808|Dose for normal volunteer undergoing dosimetry evaluation will not exceed 20 mCi, dose for high probability of Alzheimer's and low probability Alzheimer's undergoing brain imaging only will not exceed 10 mCi
16157362|NCT01723475|Biological|BAY2010112|Subcutaneous (s.c.) administration once daily. Starting dose will be 0.5 µg ; dose will be escalated dependent on any dose limiting toxicities
16157363|NCT01723475|Biological|BAY2010112|Continuous intravenous infusion (c.i.v.) administration. Starting dose will be 5 µg ; dose will be escalated dependent on any dose limiting toxicities.
16157364|NCT01723436|Other|Hypothetical scenarios and related decisions|Surrogates are exposed to three hypothetical medical scenarios that require varying levels of decision making. We will be assessing how this experience alters their subsequent choice to forego life sustaining therapy.
16157365|NCT01723410|Behavioral|Writing about people|Subjects will be asked to write about other people in their lives once a week for 6-weeks.
16157366|NCT01723410|Other|Writing about places, objects|
16162434|NCT01684540|Drug|Sinupret forte|
16157367|NCT01723397|Drug|Nasaleze Spray|Subjects are treated with over the counter Nasaleze cellulose powder nasal spray then challenged with allergen
16157368|NCT01723397|Other|Placebo spray|Subjects are treated with placebo nasal spray then challenged with allergen
16157369|NCT01723397|Biological|Allergen|Subjects are challenged with grass or ragweed allergen after treatment with Nasaleze or placebo
16157370|NCT01723384|Drug|Intermittent Oral Naltrexone|
16157371|NCT01723384|Drug|Placebo|
16157372|NCT01723371|Drug|Carvedilol|Carvedilol will be administered orally. The initial dose of carvedilol will be 0.05mg/kg/day divided into 2 doses. After two weeks, at subsequent weekly study visits, the dose of carvedilol will be increased incrementally to 0.1mg/kg in Week 2, 0.2mg/kg in Week 3, 0.4mg/kg in Week 4, 0.6mg/kg in Week 5, and 0.8mg/kg in Week 6, when the target dose of 0.8mg/kg/day (if weight is less than 62.5kg) or 50mg/day (if weight is greater than 62.5kg) is achieved. This dosage, assuming no adverse effects, will be maintained between Weeks 6 and 30 of the study. After the maintenance period from Week 6 to 30, patients will be weaned over 5 to 7 days or continued on a non-study drug supply.
16157373|NCT01723358|Device|Neuromuscular electrical stimulation (NMES)|The intervention will consist of a period of treatment with NMES. This treatment will involve 20-45 minute feeding therapy sessions during which NMES will be administered by an Occupational Therapist. Frequency of therapy sessions will be 4 times per week for the first 2 weeks (as in inpatient, if hospitalized) and then biweekly for 14 weeks for a total of 36 sessions (over 16 weeks). For patients who are discharged prior to the first 2 weeks of treatment, outpatient sessions will be biweekly.
16157374|NCT01723345|Drug|omega 3|3 gram omega 3 (400mg EPA and 200mg DHA) 12hours before PCI
16157375|NCT01723332|Behavioral|Educational|"The first interaction will happen at study enrolment and will be educational in nature.
~Following the session, the nurse will follow up with the participant to discuss any questions."
16157376|NCT01723332|Behavioral|Self management|"The second interaction will take place 2 months after enrollment and will focus on self management and communication skills.
~Following the session, the nurse will follow up with the participant to discuss any questions."
16157377|NCT01723319|Device|HBLPADD coil deep TMS|20 daily deep TMS treatment
16157378|NCT01723319|Device|Sham|inactive treatment
16157379|NCT01723306|Genetic|Gene Modified T Cells|Subjects will undergo T cell leukopheresis. The collected T cells will be genetically modified, and then re-infused peripherally. IL2 will be given concomitantly for 30 days post modified T cell infusion via CADD pump.
16157380|NCT01723293|Behavioral|Exercise group|"The physical conditioning program included a total of three 55-60 minute sessions per week. Pregnant women started in 9-12 weeks and finished in 38-40 weeks, therefore, an average of 85 training sessions were planned for each participant. All subjects wore a heart rate (HR) monitor (Polar FT7, Finland) during the training sessions to ensure that the exercise intensity was light to moderate.
~Each session included a 25-minutes of aerobic exercise, 10-minutes of strength exercise and balance exercise as well, and 10-minutes of pelvic floor muscles training."
16157381|NCT01723280|Drug|Oxygen|During and 2 hrs after surgery
16157382|NCT01723267|Other|3D follicles assessment|3D ultrasound evaluation in IVF treatment (vs 2D ultrasound)
16157383|NCT01723267|Other|2D follicles assessment|2D ultrasound in IVF treatment (vs 3D ultrasound)
16157384|NCT01723254|Biological|IGE-1|Intramuscular, multiple dose
16157385|NCT01723254|Biological|IGE-2|Intramuscular, multiple dose
16157386|NCT01723254|Biological|Saline|Saline (0.9% sodium chloride)
16157387|NCT01723241|Drug|XAF5, concentration A|
16157388|NCT01723241|Drug|XAF5, concentration B|
16157389|NCT01723241|Drug|XAF5, concentration C|
16157390|NCT01723241|Drug|Placebo|
16157391|NCT01723228|Drug|Rasagiline|
16157392|NCT01723228|Drug|Placebo|
16157393|NCT01723215|Behavioral|Active ABMT8|Active ABMT8 8 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance
16157394|NCT01723215|Behavioral|Active ABMT4|Active ABMT4 4 active ABMT sessions (10 min. each, over 7-8 weeks) designed to promote adaptive threat attendance
16157395|NCT01723215|Behavioral|Placebo|Placebo: will receive 4 training sessions(10 min. each, over 7-8 weeks) using the same task and stimuli as in the active arms, but not designed to change attention patterns
16157396|NCT01723202|Drug|dabrafenib|150 mg orally twice daily given orally
16157397|NCT01723202|Drug|trametinib|150 mg orally twice daily and GSK1120212 (MEKi) 2 mg orally once daily given orally
16157398|NCT01723202|Other|Correlative Studies|"Signaling inhibition studies in tumor biopsies (10 pts in each arm; 5 pts per center)
~BRAF mutation studies in circulating plasma DNA (all study patients)
~Mechanisms of drug resistance in tumor biopsies or tumor blocks (5 pts in each arm)
~Assess predictors of response (Archival tumor block/unstained slides in all study patients)
~Pharmacokinetic studies (First 10 pts enrolled on each arm)
~Pharmacogenomics studies (All study patients)"
16157399|NCT01723176|Procedure|Echocardiography|
16157400|NCT01723163|Behavioral|Abstinence Reinforcement Therapy (ART)|Veterans randomized to the intervention will receive cognitive-behavioral telephone counseling (TC), a tele-medicine clinic for access to nicotine replacement (NRT), and mobile contingency management (mCM)
16157401|NCT01723163|Behavioral|Telephone Counseling and NRT|Veterans randomized to the control group will receive cognitive-behavioral telephone counseling (TC) and a tele-medicine clinic for access to nicotine replacement (NRT)
16157402|NCT01723150|Drug|Ciprofloxacin|
16157403|NCT01723150|Drug|Ceftriaxone|
16157404|NCT01723150|Drug|Trimethoprim/sulfamethoxazole|
16157405|NCT01723150|Drug|Ertapenem|
16157406|NCT01723124|Procedure|Molecular Breast Imaging|Molecular Breast Imaging (MBI) utilizes small high resolution gamma camera detectors in a dual-detector configuration to image the breast following the administration of a radiopharmaceutical that accumulates preferentially in breast tumors.
16157407|NCT01723098|Behavioral|Exercise group|"Supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training
~Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60 of maximal heart rate. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate."
16157408|NCT01723072|Biological|Omalizumab|Humanized monoclonal antibody against human IgE
16157409|NCT01723072|Drug|Placebo|Placebo to omalizumab
16157410|NCT01723059|Drug|Standard Triple Therapy|for 10 days
16157411|NCT01723059|Drug|Sequential Therapy|total 10 days
16157412|NCT01723046|Device|Training with new upper limb robot assisted therapy device|During 8 weeks, 3 times a week, 1 hour therapy sessions with the device
16157413|NCT01723020|Drug|AMG 232|Given an an oral tablet in escalating doses.
16157414|NCT01723007|Other|Supplement|The arms were assigned to receive the supplements and followed for 10 weeks. Every two weeks, the women returned to the clinic for evaluation biochemical, haemogram, anthropometric, bioimpedance, blood pressure and dietary. Weekly, returned to receive the supplements in a sealed box. They received guidance not to disclose what food were receiving the service if he found other women who also participated in the study.
16157415|NCT01722994|Device|Polyglactin 910 sterile synthetic absorbable suture (Ethicon)|Half of punch biopsy wounds are closed with each absorbablesuture
16157416|NCT01722994|Device|Chromic Gut Sterile absorbable Suture (Ethicon)|
16157417|NCT01722981|Procedure|Percutaneous tracheostomy|Three methods of percutaneous tracheostomy
16157418|NCT01722968|Drug|Bevacizumab|15mg/kg administered iv every 3 weeks in combination with paclitaxel 80mg/m2 iv weekly
16157419|NCT01722968|Drug|Paclitaxel|80mg/m2 iv weekly
16157420|NCT01722955|Other|Pre-warmed fluids|IV fluid will be stored at 41℃ set hot cabinet for 8hours
16157421|NCT01722955|Other|Room temperature fluids|Room temperature fluid will be stored at ambient temperature
16157422|NCT01722942|Procedure|ICD implantation|ventricular ICD implantation
16157423|NCT01722942|Drug|amiodarone hydrochloride|amiodarone prescription
16157424|NCT01722929|Device|Skin sensor|
16157425|NCT01722916|Drug|Hyaluronidase|
16157426|NCT01722877|Device|JetStream Navitus|Study to use Jetstream device for use of in-stent restenosis in femoral popliteal artery.
16157427|NCT01722864|Drug|COV155|COV155 tablets
16157428|NCT01722838|Behavioral|B-ME Intervention|B-ME is a behavioral intervention of HIV prevention risk reduction administered in a group format during a 2.5 day retreat (19 hours) format.
16157429|NCT01722825|Drug|LY2157299|Administered orally.
16157430|NCT01722812|Drug|Cromoglicate|Twice daily topical treatment for 14 days
16157431|NCT01722812|Drug|Placebo|Twice daily topical treatment for 14 days
16157432|NCT01722799|Device|Drug elluting Balloon (DEB)|Percutaneous transluminal coronary angioplasty with drug elluting ballon and Bare metal stent for rescue.
16157433|NCT01722799|Device|Drug elluting coronary stent (DES)|Percutaneous transluminal coronary angioplasty (PTCA) with stent
16157434|NCT01722773|Device|Bipap (Respironics, Inc)|Bipap every night pressure at 15/5 with heated humidifier
16157435|NCT01722760|Procedure|measurements|
16157436|NCT01722747|Behavioral|Tobacco Free Teachers, Tobacco Free Society (TFT/TFS)|A 7-month intervention was conducted over one academic year & included the following core components: 1. A Lead Teacher (LT) in each school was appointed and trained to facilitate the program on-site; 2. A tobacco policy was implemented; 3. Study health educators and LTs conducted group discussions with teachers addressing 6 intervention themes; 4. Materials; 5. Support for tobacco use cessation. Schools randomized to delayed intervention control condition did not receive any intervention until after final data collection, when they were given a 3-month shortened intervention.
16157437|NCT01722734|Behavioral|Text message reminders|Patients in the two treatment arms receive six short text message reminders within 60 hours of treatment initiation at 12 hour intervals to remind them to take their malaria medication as prescribed.
16157438|NCT01722708|Drug|Clindamycin|Oral clindamycin 300 Milligrams*2/Day for a week
16157439|NCT01722708|Drug|Metronidazole|Oral metronidazole 500 Milligrams*2/Day for a week
16157440|NCT01722695|Other|Dialyzer comparison|"Each patient is treated by hemodialysis for one week (3 sessions) with each dialyzer type (Revaclear or FX).
~The order of dialyzers used will be randomly assigned to the patient at randomization."
16157441|NCT01722682|Biological|Human pancreatic islet transplantation|
16157442|NCT01722669|Drug|isoquercetin or quercetin|Single dose PK/PD study
16157443|NCT01722656|Drug|Aflibercept|
16157444|NCT01722643|Behavioral|MAxIM|This new intervention, called MAxIM (MotivAtion, Incentives, Memory) uses: 1) motivation enhancement therapy (MET) (an existing evidence-based treatment for adolescent with diabetes) supplemented with cognitive behavior therapy (CBT) to enhance behavior change; 2) financial incentives for daily blood glucose testing and parental monitoring to provide frequent positive feedback; and 3) working memory training (WMT), a method for strengthening specific cognitive processes that support decision-making and future orientation. The interventions will be delivered to families at home via the internet.
16157445|NCT01722643|Behavioral|Usual Care|Usual Care reflects the standard treatment currently provided at the Children's Hospital at Dartmouth. Teens will be followed by their treating endocrinologist and receive the following standard services as part of that treatment-quarterly outpatient clinic visits, including an interval medical history and physical examination; routine laboratory assessment; review of glycemic control, medication adjustment, medical nutrition therapy, and diabetes self-management education; telephone consultations with a nurse/certified diabetes educator in their treating clinic are available as often as necessary between clinic visits.
16157446|NCT01722630|Drug|Dopamine|
16157447|NCT01722617|Other|Questionnaire|Patients in groups 2 and 3 will be asked to fill in questionnaires FLARE.
16157448|NCT01722604|Drug|brinzolamide 1% ophthalmic suspension|brinzolamide 1% ophthalmic suspension
16157449|NCT01722604|Drug|Azopt 1%|Azopt 1%, RLD
16157450|NCT01722591|Device|Cardiapex device|Cardiapex percutaneous transapical access and closure system
16157451|NCT01722578|Drug|L-ornithine L-aspartate|L-ornithine L-aspartate (6 ampules, each ampule containing 5 grams of the drug in 10 ml solution) to be diluted in 440 ml of Dextrose 5% (to make a total of 500 ml of solution), as intravenous infusion at the rate of 21 ml/hour, over 24 hours, for 5 days
16157452|NCT01722578|Drug|Placebo|Placebo (sterile water, 60 ml) diluted in 440 ml of Dextrose 5%, as intravenous infusion at the rate of 21 ml/hour, over 24 hours, for 5 days
16157453|NCT01722565|Procedure|laparoscopic abdominoperineal resection with a lightweight mesh (polypropylene and poliglecaprone 25)|
16157455|NCT01722552|Behavioral|standard of care|
16157456|NCT01722539|Drug|Sulfadoxine-pyrimethamine|Tablets 500 mg sulfadoxine - 25 mg pyrimethamine will be given as single oral dose of ½ tablets per 10 kg of weigh: 1 tablet for weigh less than 20 kg, 1.5 tablets in 20-29 kg, and 2 tablets for children of weigh 30 or more
16157457|NCT01722539|Drug|Piperaquine|Piperaquine tablet 320 mg manufactured by Sigma Tau will be used at two treatment doses of 16-24 mg/kg at 24 hours intervals as follows: 1 tablets for weigh 15-19 kg, 1.5 tablets for 20-29 kg, and 2 tablets for 30-39 kg, and 2.5 tablets for 40 kg or more.
16157458|NCT01722539|Drug|Albendazole|One oral 200 mg will be given to children of 1-2 years and one oral dose of 400 mg to children older than 2 years. The treatment will be repeated at 4-months in the follow-up in accordance with the WHO guideline.
16157459|NCT01722539|Drug|Praziquantel|Praziquantel is a tremacide used for treatment of infections due to schistosomes. Praziquantel will be given as one dose of 40 mg/kg at enrolment and at 12 months follow up.
16157460|NCT01722526|Drug|Recombinant human acid sphingomyelinase|Administered intravenously every 2 weeks for 26 weeks
16157461|NCT01722513|Drug|Alprostadil ﹠control|control:Normal salin 1cc/kg/hr before and after angiography
16157462|NCT01722487|Drug|Ibrutinib|Ibrutinib will be supplied as hard gelatin 140-mg capsules for oral (PO) administration. Ibrutinib 420 mg (3 x 140-mg capsules) is administered orally once daily. The first dose will be delivered in the clinic on Day 1, after which subsequent dosing is typically on an outpatient basis. Ibrutinib will be dispensed to patients in bottles at each visit.
16157463|NCT01722487|Drug|Chlorambucil|Chlorambucil will be supplied as 2-mg tablets for PO administration. Chlorambucil is administered orally on Days 1 and 15 of each 28-day cycle. The starting dosage (Cycle 1) is 0.5 mg/kg. If well tolerated, the Chlorambucil dose can be increased starting at Cycle 2, with increments of 0.1 mg/kg on Day 1 of each cycle to a maximum of 0.8 mg/kg.
16157464|NCT01722474|Device|ASI Device|
16157465|NCT01722461|Device|Ulthera System|Focused ultrasound energy delivered below the surface of the skin
16157466|NCT01722461|Device|Sham treatment|Ulthera System delivering no ultrasound energy
16157467|NCT01722448|Dietary Supplement|Choline|4 capsules with 480 mg choline per day
16157468|NCT01722448|Dietary Supplement|Placebo|
16157469|NCT01722435|Drug|Opiate Substitution Treatment|
16157470|NCT01722422|Drug|oxygen and saline|
16157471|NCT01722409|Drug|sevoflurane and 0.5 μg/kg dexmedetomidine|After induction of general anesthesia, Group DEX1 received a single dexmedetomidine dose of 0.5 μg/kg over 10 minutes.
16157472|NCT01722409|Drug|sevoflurane and 1 μg/kg dexmedetomidine|After induction of general anesthesia, Group DEX2 received a single dexmedetomidine dose of 1 μg/kg over 10 minutes.
16157473|NCT01722396|Dietary Supplement|Vitamin D|
16157474|NCT01722370|Drug|Oxygen|
16157475|NCT01722370|Drug|Medical air equivalent|
16157476|NCT01722357|Behavioral|Pedometer|Participants are provided with Omron Model HJ-151 pedometers and given instruction on how to use the pedometer to set goals for increasing physical activity. They are given diaries to track their daily step counts.
16157477|NCT01722357|Behavioral|Exercise Counseling|Manualized cognitive behavioral treatment program including goal setting, adding exercise throughout the day, physical limitations/injuries, maintaining motivation, benefits of exercise, FITT principles, exercise as recreation, and restructuring thoughts related to activity.
16157478|NCT01722344|Behavioral|Individual Placement and support (IPS)|IPS involves an employment specialist who is integrated within the mental health team, and carries out all phases of the vocational services, with a caseload on less than 25. The intervention is based on the 7 principles of IPS Supported Employment. The essence of these principles is an individualized and rapid search for competitive employment or education that avoids prolonged prevocational training and preparation. The intervention is integrated within the mental health services, with emphasis on client preference and choice regarding jobs, and with availability of on going job support and benefit counselling
16157479|NCT01722344|Behavioral|IPS plus|Individual Placement and Support + cognitive remediation and work-related social skills training, consists of the IPS intervention + 24 sessions of computer based cognitive training and 24 group based sessions of cognitive coping strategies and work-related social skills training.
16157480|NCT01722331|Drug|Tildrakizumab 200 mg|Two tildrakizumab 100 mg/mL pre-filled syringes (PFS)
16157481|NCT01722331|Drug|Tildrakizumab 100 mg|Tildrakizumab 100 mg/mL PFS
16157482|NCT01722331|Drug|Matching Placebo|Matching placebo to tildrakizumab PFS
16157483|NCT01722318|Drug|Plecanatide|
16157484|NCT01722318|Drug|Placebo|
16157485|NCT01722305|Drug|Dexamethasone|Given PO
16157486|NCT01722305|Other|Laboratory Biomarker Analysis|Optional correlative studies
16157487|NCT01722305|Other|Pharmacological Study|Optional correlative studies
16157488|NCT01722305|Drug|Pomalidomide|Given PO
16157489|NCT01722292|Drug|LY2940680|Administered orally
16157490|NCT01722292|Drug|Carboplatin|Administered IV
16157491|NCT01722292|Drug|Etoposide|Administered IV
16157492|NCT01722292|Drug|Placebo|Administered orally
16157493|NCT01722279|Procedure|Bariatric surgery|
16157494|NCT01722266|Drug|Liraglutide|"Patients randomized to 1.2 mg of liraglutide : They will start liraglutide 0.6 mg sc once daily for one week and will increase the dose to 1.2 mg sc once daily thereafter.
~Patients randomized to 1.8 mg of liraglutide: They will start liraglutide 0.6 mg sc once daily for one week; will increase to 1.2 mg sc once daily for second week and will stay on 1.8 mg of liraglutide from third week onwards."
16157495|NCT01722266|Drug|Placebo|"Patients randomized to 1.2 mg of placebo: They will start placebo 0.6 mg sc once daily for one week and then increase to 1.2 mg once daily thereafter.
~Patients randomized to 1.8 mg of placebo: They will start placebo 0.6 mg sc once daily for one week; increase to 1.2 mg sc once daily for second week and then to 1.8 mg sc once daily from third week onwards."
16157496|NCT01722253|Procedure|Electroacupuncture|Electrical stimulation device with frequency 2 Hz and 'frequency scanning mode'
16157497|NCT01722240|Drug|Liraglutide 1.8mg|
16157498|NCT01722240|Drug|Placebo|
16157499|NCT01722227|Drug|Liraglutide|
16157500|NCT01722227|Drug|Placebo|
16157501|NCT01722214|Biological|Adalimumab|Injection of adalimumab (80 mg followed by 40 mg at week 1 and 40 mg EOW thereafter for 52 weeks). For Adalimibab group and Placebo group.
16157502|NCT01722214|Other|Placebo|Injection of placebo that is physicaly identical to adalimumab without the active ingredient at identical intervals.
16157503|NCT01722201|Drug|Risperidone Tablet 1 mg|1 mg tablet once a day
16157504|NCT01722201|Drug|Risperidone|1 mg tablet once a day
16157505|NCT01722175|Procedure|ALPPS surgery|
16157506|NCT01722175|Procedure|PVO surgery|
16157507|NCT01722162|Drug|Bevacizumab|
16157508|NCT01722162|Drug|Capecitabine|
16157509|NCT01722162|Drug|Levocetirizine|
16157510|NCT01722149|Genetic|Adoptive Transfer of re-directed T cells|Adoptive Transfer of 10e6 re-directed T cells in the pleural effusion
16157511|NCT01722136|Behavioral|Low Dosage|Exercise dose of 8kcal/kg/week
16157512|NCT01722136|Behavioral|High Dosage|Exercise dose of 14kcal/kg/week
16157513|NCT01722123|Other|Hypothetical scenarios and related decisions|Patients are exposed to three hypothetical medical scenarios that require varying levels of decision making. We will be assessing how this experience alters their subsequent choice to forego life sustaining therapy.
16157514|NCT01722110|Drug|Indomethacin Extended-Release Capsules USP 75 mg|75 mg tablet once a day
16157515|NCT01722110|Drug|Indomethacin Extended Release Capsules USP 75 mg|75 mg tablet once a day
16157516|NCT01722097|Drug|Rocuronium|
16157517|NCT01722097|Drug|placebo|
16157518|NCT01722084|Behavioral|Theory of planned behaviour (TPB) and social cognitive theory (SCT).|"TPB is appropriate to influence adolescents' behaviour related to the use of contraceptive methods and their health/information seeking behaviour. The SCT helped to find out strategies to improve communication about sexuality, to promote openness towards adolescents' sexuality among parents, community members and health providers and for health providers to adopt a more adolescent friendly attitude.The development of the strategies in the different countries is a dynamic process that is continuously being adapted. The target groups were driving the process of identifying, selecting and implementing interventions. Therefore, local institutions were involved in the intervention. Attention was paid to ensure that the interventions were in line with the existing local structures/policies and reinforce the local health system.Primary health care services had a key role in the interventions. Gender was a transversal topic throughout the intervention process."
16157519|NCT01722071|Drug|Placebo|Placebo intranasal administration, 3 puffs per nostril delivered approximately 30 minutes prior to scanning session.
16157520|NCT01722071|Drug|Oxytocin|Oxytocin intranasal administration, 24 IU, 3 puffs per nostril at 4 IU per puff delivered approximately 30 minutes prior to scanning session.
16157521|NCT01722058|Drug|Peptide application|
16157522|NCT01722045|Drug|Intravitreal Aflibercept Injection (IAI)|
16157523|NCT01722032|Other|Childhood Obesity|
16157524|NCT01722019|Device|Tulip fiber|Laser ablation with a wavelength of 1470 nanometers will be performed, in combination with a new sort of fiber: the tulip tip fiber.
16157525|NCT01722019|Device|VNUS closure fast|Radiofrequent ablation will be performed in combination with the catheter 'VNUS closure fast'.
16157526|NCT01722006|Behavioral|Pairing condition|
16157527|NCT01722006|Behavioral|Pairing condition|20 mg methamphetamine or placebo on four 4-hour laboratory sessions
16157528|NCT01721993|Drug|T121|
16157529|NCT01721993|Drug|Zoledronic acid|
16157530|NCT01721980|Drug|GLPG0974|
16157531|NCT01721980|Drug|Placebo|
16157532|NCT01721967|Drug|Ranolazine|
16157533|NCT01721954|Drug|FOLFOX6m|
16157534|NCT01721954|Device|SIR-Spheres microspheres|
16157535|NCT01721941|Drug|Phase I Dose level -1|The dose of TH-302 will be mixed with doxorubicin 50mg to use as the chemoembolization mixture for transarterial chemoembolization (TACE).
16157536|NCT01721941|Drug|Phase I dose level 1|The dose of TH-302 will be mixed with doxorubicin 50mg to use as the chemoembolization mixture for transarterial chemoembolization (TACE).
16157537|NCT01721941|Drug|Phase I Dose level 2|The dose of TH-302 will be mixed with doxorubicin 50mg to use as the chemoembolization mixture for transarterial chemoembolization (TACE).
16157538|NCT01721941|Drug|Phase I Dose level 3|The dose of TH-302 will be mixed with doxorubicin 50mg to use as the chemoembolization mixture for transarterial chemoembolization (TACE).
16157539|NCT01721928|Device|Continuous venovenous hemodialysis|Continuous venovenous hemodialysis
16157540|NCT01721915|Drug|Vitamin D supplementation|The treatment group will receive an oral dose of 20,000 IU vitD weekly (equivalent to 2857 IU/day) as oily drops (Oleovit D3-drops; producer: Fresenius Kabi Austria GmbH, Linz)
16157541|NCT01721915|Drug|Placebo|
16157542|NCT01721902|Device|Autologous CD133+ Bone Marrow Stem Cells|Intra-myocardial injection of 2-3 x 10E6 CD133+ Bone Marrow Stem Cells
16157543|NCT01721902|Other|Carrier Solution|Intra-myocardial injection of carrier solution
16157544|NCT01721889|Radiation|Radiostereometric Analysis|The radiostereometric (RSA) patient exam (flexion and extension RSA images) presents additional radiation exposure to the patient above standard of care (additional radiographs). Assuming 120kV, using three protocols (two loaded and one unloaded) per RSA exam results in a typical effective dose of approximately 2.04mSv per exam(single lumbar spine RSA at 120kV yields 0.68mSv,). HBI recommends using 140kV for lumbar spine RSA and has conducted simulations to estimate the effective dose using higher kV settings. 140kV reduces the effective dose from 0.68mSv per spine RSA to 0.2mSV, resulting in a total effective dose per RSA exam of 0.6mSv. In comparison, the estimated effective dose for a single standard lumbar spine x-ray is 1.2mSv. This additional radiation exposure is considered to be minimal risk in consideration of the number of planar x-rays the patient will undergo as part of standard care, as well as average background radiation received by humans per year (3.1mSv).
16157545|NCT01721876|Drug|Placebo|Placebo matching Volasertib
16157546|NCT01721876|Drug|Volasertib|Volasertib
16157547|NCT01721876|Drug|Cytarabine|Cytarabine
16157548|NCT01721863|Other|Exercise training|Exercise group will undergo progressively aerobic exercise training with 40-85% maximal oxygen consumption for 40 minutes, 3 sessions per week for 12 weeks.
16157549|NCT01721850|Other|control formula|commercial stage 1 infant formula
16157550|NCT01721850|Other|intervention formula 1|infant formula with hydrolyzed protein (type I) and pre- and probiotics
16157551|NCT01721850|Other|intervention formula 2|infant formula with hydrolyzed protein (type II) and pre- and probiotics
16157606|NCT01721434|Drug|Placebo|Similar coloured placebo
16157552|NCT01721824|Behavioral|The IPS-MA method|During the first 6 months participants are usually offered 3 meetings with their mentor per month, lasting approximately 1 1/2 hours each. The following 6 months they are offered 1 meeting per month, lasting approximately 1 hour. The estimated duration of the IPS-MA intervention is 12 months, but since the needs of the participants are very individual, this may vary.
16157553|NCT01721811|Other|Hyperoxia|
16157554|NCT01721811|Other|Glucose|
16157555|NCT01721798|Device|Mirena levonorgestrel IUD|Intrauterine contraception system
16157556|NCT01721798|Device|Copper T-380a IUD|intrauterine contraception system
16157557|NCT01721785|Drug|GADOFOSVESET TRISODIUM 244 Mg in 1 mL INTRAVENOUS INJECTION, SOLUTION [Ablavar]|Gadofosveset will be used as a lymph-node specific MRI contrast agent and will be administered by manual injection as a single intravenous bolus during MRI.
16157558|NCT01721772|Biological|BMS-936558 (Nivolumab)|
16157559|NCT01721772|Biological|Placebo matching BMS-936558 (Nivolumab)|
16157560|NCT01721772|Drug|Dacarbazine|
16157561|NCT01721772|Drug|Placebo matching Dacarbazine|
16157562|NCT01721759|Drug|Nivolumab|
16157563|NCT01721746|Biological|BMS-936558|
16157564|NCT01721746|Drug|Dacarbazine|
16157565|NCT01721746|Drug|Carboplatin|
16157566|NCT01721746|Drug|Paclitaxel|
16157567|NCT01721733|Drug|Placebo|
16157568|NCT01721733|Drug|EPI-743 15 mg/kg|
16157569|NCT01721733|Drug|EPI-743 5 mg/kg|
16157570|NCT01721707|Drug|Latanoprost+Brinzolamide combination|1 drop in each eye, 1x/day, at 9PM
16157571|NCT01721707|Drug|Latanoprost|1 drop in each eye, 1x/day, at 9PM
16157572|NCT01721694|Drug|azithromycin 1.5%/Loteprednol 0,5% + placebo|1 drop, AO, QID
16157573|NCT01721694|Drug|azithromycin 1.5% + Loteprednol 0,5% (separately)|1 drop, QID, AO
16157574|NCT01721681|Biological|FACTOR X|
16157575|NCT01721668|Behavioral|Music Supported Rehabilitation|Music Supported Rehabilitation -using musical exercises to improve hand and arm motor functioning.
16157576|NCT01721668|Behavioral|Conventional Upper Extremity Therapy|-GRASP (Graded Repetitive Arm Supplementary Program-developed Janice Eng, PhD, PT/OT Jocelyn Harris, PhD, OT, Andrew Dawson, MD, FRCP, Bill Miller, PhD, OT) protocol will be used to improve arm and hand function in people living with stroke.
16157577|NCT01721655|Drug|Spironolactone|Patients will continue to receive standard of care as if they were not enrolled in the study. All patients will receive oral chlorothiazide 40 mg/kg/day divided twice-daily, electrolyte supplementation as needed based on a standard algorithm, and if needed, rescue enteral furosemide 2 mg/kg/day. The intervention will be enteral spironolactone 3 mg/kg once daily
16157578|NCT01721655|Drug|Placebo|Patients will continue to receive standard of care as if they were not enrolled in the study. All patients will receive oral chlorothiazide 40 mg/kg/day divided twice-daily, electrolyte supplementation as needed based on a standard algorithm, and if needed, rescue enteral furosemide 2 mg/kg/day.
16157579|NCT01721642|Device|Apica Cardiovascular ASC Access, Stability and Closure Device|Access, stabilisation and closure of trans-apical approach for TAVI
16157580|NCT01721629|Procedure|Sudden wean of nasal CPAP|
16157581|NCT01721629|Procedure|Gradual wean of nasal CPAP|
16157582|NCT01721616|Drug|Azithromycin|
16157583|NCT01721616|Drug|Cefazolin|
16157584|NCT01721603|Drug|Dabrafenib|150 mg capsule by mouth twice daily
16157585|NCT01721603|Procedure|Gamma Knife Radiosurgery|This will be delivered using Gamma Knife technology. Patients will be fitted with a stereotactic head-frame for stereotactic localization of brain metastases.
16157586|NCT01721603|Drug|Trametinib|2 mg by mouth once daily from beginning at Cycle 3 Day 1, until progression of disease, withdrawal of consent, or the development of intolerable treatment associated toxicity.
16157587|NCT01721590|Drug|Tongxinluo|Tongxinluo,3 capsules/time 3times/day for 1 year
16157588|NCT01721590|Drug|placebo|3 capsules/time，3times/day for 1 year
16157589|NCT01721577|Drug|AXL1717|IGF-1 receptor inhibitor
16157590|NCT01721564|Drug|Bosentan|62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months
16157591|NCT01721551|Other|Exercise|Training will include a 45-60 min aerobic training on a rehabilitation cycle ergometer (Monark Rehab Trainer 881E) in the supine position during dialysis session. The intensity will progress from 30-40% of the maximum exercise power to 60-70%.
16157592|NCT01721551|Other|Usual Treatment|The CON group received no intervention but the usual treatment
16157593|NCT01721538|Other|Weight reduction program|
16157594|NCT01721538|Other|Lecture on healthy nutrition|
16157595|NCT01721525|Drug|Afatinib, Ribavirin, and weekly carboplatin/paclitaxel|Patients will receive oral daily afatinib (days 1 - 21, per dose escalation scheme) plus daily oral ribavirin (days 1- 21) and paclitaxel (80 mg/m2 intravenously, days 1 and 8) + carboplatin (AUC 1.5 intravenously, days 1 and 8) of a 21-day cycle. Ribavirin will be administered according to standard weight-based dosing for this drug (1). Subjects ≤75 kg receive Ribavirin 400 mg PO qAM and 600 mg PO qPM (= 1000 mg/day). Subjects > 75 kg receive Ribavirin 600 mg PO BID (=1200 mg/day). During the Dose Escalation portion of the study (Part 1), research bloodwork for pharmacokinetics is performed on days 1 and 8 of Cycle 1 only.
16157596|NCT01721512|Other|Breastfeeding|
16157597|NCT01721512|Other|Infant formula|
16157598|NCT01721499|Behavioral|Nutritional Counseling|weekly group and individual skills training to improve self control and decrease stress.
16157599|NCT01721499|Behavioral|Mindfulness Intervention|
16157600|NCT01721486|Drug|IV acetaminophen|IV acetaminophen 15 mg/kg (up to 1000 mg) over 15 minute infusion after IV placement in OR .
16157601|NCT01721486|Drug|PO acetaminophen|PO acetaminophen elixir 15 mg/kg (up to 1000 mg) administered approximately 90 minutes (+/- 30minutes) prior to induction of anesthesia in the pre-operative area.
16157602|NCT01721473|Other|positron emission tomography scan|2-FA positron emission tomography scan
16157603|NCT01721460|Drug|Dexmedetomidine|Dexmedetomidine infusion will be started with a loading dose of 1 mcg/Kg over ten to 20 minutes followed by a maintenance infusion of 0.7 mcg/Kg/hr until stable sedation is achieved.
16157604|NCT01721447|Drug|Optison echocardiography contrast agent|Subjects undergoing transesophageal echocardiography who will receive the Optison contrast agent during the procedure to test if the image quality improves to provide accurate assessment of the presence of left atrial thrombus.
16157607|NCT01721421|Other|extended treatment time|patients receive extended dialysis treatment time time of 6 hours
16157608|NCT01721421|Other|Standard treatment time|
16157609|NCT01721408|Drug|Tigecycline|every 12 hours (an initial intravenous dose of 100 mg followed by 50 mg twice a day approximately every 12 hours) and placebo intravenous doses every 12 hours beginning 6 hours after the initial intravenous dose of tigecycline for at least for 5 days and up to 14 days.
16157610|NCT01721408|Drug|Imipenem/cilastatin|every 6 hours intravenously, and the imipenem/cilastatin will be dosed by 500mg/500mg for the subjects with creatinine clearance equal or above 71ml/min/1.73m2 or dose will be adjusted by Schedule of Study Drug Administration for Subjects with Renal Impairment.
16157611|NCT01721395|Dietary Supplement|Agave Syrup|
16157612|NCT01721382|Drug|Sitagliptin|
16157613|NCT01721369|Diagnostic Test|Transient Loss of Consciousness (T-LOC)|
16157614|NCT01721343|Behavioral|telephone-based intervention|Undergo telephonic monitoring
16157615|NCT01721343|Other|case management|Participate in an individualized conditioning program with an RCM
16157616|NCT01721343|Procedure|management of therapy complications|Undergo enhanced usual care with an RCM and PCM
16157617|NCT01721343|Procedure|physical therapy|Participate in an individualized conditioning program with an RCM
16157618|NCT01721343|Other|questionnaire administration|Ancillary studies
16157619|NCT01721343|Procedure|quality-of-life assessment|Ancillary studies
16157620|NCT01721343|Procedure|management of therapy complications|Undergo enhanced usual care
16157621|NCT01721343|Procedure|assessment of therapy complications|Undergo enhanced usual care
16157622|NCT01721343|Other|educational intervention|Participate in an individualized conditioning program with an RCM
16157623|NCT01721343|Procedure|management of therapy complications|Undergo enhanced usual care with an RCM
16157624|NCT01721343|Procedure|assessment of therapy complications|Undergo enhanced usual care with an RCM
16157625|NCT01721343|Procedure|assessment of therapy complications|Undergo enhanced usual care with an RCM and PCM
16157626|NCT01721330|Drug|Naltrexone|Up to 100mg of Naltrexone once a day for 6 weeks
16157627|NCT01721330|Drug|Placebo|Placebo twice a day for 6 weeks
16157628|NCT01721317|Drug|Ezogabine/Retigabine IR|Subjects received drug (dose strength 300 mg to 1200 mg) orally with or without food. The 3 daily doses are to be administered with approximately an 8-hour interval between them.
16157629|NCT01721317|Drug|Placebo|Matching placebo will be available
16157630|NCT01721304|Other|Adaptive Conjoint Analysis|Computerized survey to elicit patient preferences
16157631|NCT01721291|Drug|SALBUTAMOL|"In the LUNG DEPOSITION STUDY; SALBUTAMOL INHALED VIA RESEARCH NEBULISER at 3 PARTICLES SIZES OF 1.5 MICRONS, 3 MICRONS AND 6 MICRONS WILL BE GIVEN AT SLOW INHLATION AND AGAIN AT FAST INHALTION;DOSAGE- 30 MICROGRAMS, ONE SINGLE INHALATION ONLY. IN ADDITION, SALBUTAMOL AT 200 MICROGRAMS INHALED VIA A STANDARD METERED DOSE INHALER WILL ALSO BE GIVEN AS A SINGLE INHALATION.
~In the LUNG PHYSIOLOGY STUDY; SALBUTAMOL INHALED VIA RESEARCH NEBULISER at 3 PARTICLES SIZES OF 1.5 MICRONS, 3 MICRONS AND 6 MICRONS WILL BE GIVEN AT TWO DOSAGES OF 30 MICROGRAMS AND AGAIN AT 15 MICROGRAMS, ONE SINGLE INHALATION ONLY. IN ADDITION, SALBUTAMOL AT 200 MICROGRAMS INHALED VIA A STANDARD METERED DOSE INHALER WILL ALSO BE GIVEN AS A SINGLE INHALATION. ALL INHALATIONS WIL BE AT SLOW INHALTION IN THIS PART OF THE STUDY."
16157632|NCT01721239|Other|Standardized Followup program|Standardized written information, patient photos and three followup consultations.
16157633|NCT01721226|Device|Intervention Arm (computer-based CARE+ Corrections tool)|Study participants in the intervention arm will complete the computer-based CARE+ Corrections tool at baseline. The CARE tool provides tailored feedback based on the participants' responses to a series of questions included in the counseling session. Participants in this arm of the study recruited inside the DC DOC will receive typical discharge planning services as conducted by the correctional facility. Participants will be followed for six months after release/study enrollment. At the post-release baseline visit, participants in the intervention arm will receive a cell phone/SMS text messaging intervention consisting of using cell phone-delivered SMS text messages with the intent of improving linkage to community HIV care and adherence to ART (if prescribed.)
16157634|NCT01721226|Other|Educational video on opiate overdose prevention|Participants in the Control Arm will view an educational video on opiate overdose prevention in jail prior to release. Control arm participants will be followed after release/study enrollment, just like participants in the Intervention Arm, and Plasma Viral Loads will be collected from them at baseline and follow-up.
16157635|NCT01721213|Drug|Trobalt™|Trobalt™ is a potassium channel opener used as an adjunctive treatment for partial onset seizures (a form of epilepsy where a seizure begins in a specific area in one side of the brain), with or without secondary generalization in adults aged 18 years and above with epilepsy.
16157636|NCT01721200|Other|Decision Support Tool|Educational decision support tool for patients with rheumatoid arthritis
16157637|NCT01721200|Other|Usual Care|Subjects randomized to the Usual Care Group will receive their biologic drug teaching from the rheumatologist as part of their routine care.
16157638|NCT01721174|Procedure|SEMS only|The SEMS (Niti-S biliary uncovered metallic stent; Taewoong Medical, Korea) would be placed.
16157639|NCT01721174|Procedure|EBRFA and SEMS|The radiofrequency ablation (RFA) catheter would be placed under fluoroscopic guidance across the biliary stricture. The Habib EndoHPB (EMcision UK, London, United Kingdom) radiofrequency ablation catheter is a bipolar RFA probe that is 8F (2.6 mm), 1.8 m long, compatible with standard (3.2-mm working channel) side-viewing endoscopes, and passes over 0.035-inch guidewires. The catheter has 2 ring electrodes 8 mm apart with the distal electrode 5 mm from the leading edge, providing local coagulative necrosis over a 2.5-cm length. Depending on the length of the stricture, sequential applications would be applied to complete treatment throughout the length of the stricture without significant overlap of treated areas. An uncovered SEMSs (Niti-S biliary uncovered metallic stent; Taewoong Medical, Gimpo City, Korea) would be placed after 2 sessions of EBRFA.
16157640|NCT01721161|Biological|BIIB033 (anti-LINGO-1 mAb)|100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses).
16157641|NCT01721161|Drug|Placebo|via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses)
16157642|NCT01721148|Drug|ASLAN002( BMS 777607)|100mg, 200mg, 300mg, 450mg, 600mg
16157643|NCT01721135|Drug|GSK2190915 100mg|Film coated oral tablet
16157644|NCT01721135|Drug|GSK2190915 200mg|Film coated oral tablet
16157645|NCT01721135|Drug|moxifloxacin 400mg|Film coated oral tablet
16157646|NCT01721135|Drug|moxifloxacin placebo|Film coated oral tablet
16157647|NCT01721135|Drug|GSK2190915 placebo|Film coated oral tablet
16157648|NCT01721109|Drug|EVG/COBI/FTC/TDF|150/150/200/300 mg STR administered orally once daily with food
16157649|NCT01721096|Device|XIENCE PRIME - Long Length (LL)|Long Length
16157650|NCT01721096|Device|XIENCE PRIME - Core Size|Core Size
16157651|NCT01721083|Procedure|Procedure: Z-track|Subject received immunization by z-track
16157652|NCT01721083|Procedure|Procedure: Bunch|Subject receives immunization by bunch method.
16157653|NCT01721070|Drug|Sufentanil NanoTab (SUF NT) 15 mcg|Period 1: One dose of SUF NT 15 mcg administered sublingually
16157654|NCT01721070|Drug|Ketoconazole 400 mg, sufentanil NanoTab (SUF NT) 15 mcg|Period 2: Ketoconazole 400 mg administered daily for three days, SUF NT 15 mcg co-administered sublingually on the third day
16157655|NCT01721057|Drug|Placebo|Administered orally
16157656|NCT01721057|Drug|Baricitinib|Administered orally
16157657|NCT01721057|Drug|cDMARD|Conventional disease-modifying anti-rheumatic drug as a background therapy
16157658|NCT01721044|Drug|Placebo|Administered orally
16157659|NCT01721044|Drug|Baricitinib|Administered orally
16157660|NCT01721044|Drug|cDMARD|Participants will continue to take background cDMARD therapy throughout study.
16157661|NCT01721031|Procedure|DPNB|Patients receive DPNB 30min before extubation at the end of operation
16157662|NCT01721031|Drug|Tramadol|Patients receive intravenous tramadol 1.5mg/kg 30min before extubation at the end of operation.
16157663|NCT01721018|Biological|HSV1716 Intra-pleural delivery|
16157664|NCT01721005|Other|Subject education to pulse palpation|The subject is educated to pulse palpation by registered cardiac nurse. The education time is limited to 10 minutes and done according preplanned education model.
16157665|NCT01720992|Other|A theory-based action planning toolkit|The toolkit will be distributed to the participants for their use at home, like a 'homework assignment', for the purpose of enhancing their intention and practices of the suggested behaviours. The development of the booklet was guided by the theory of The Health Action Process Approach (HAPA), which suggests that one's intention can be foster by knowing that the new behaviour has positive outcomes as opposed to the negative outcomes that accompany the current behaviour; and planning (action planning and coping planning) serves as an operative mediator between intentions and behaviour (Schwarzer, 2008). Previous evidence has shown the applicability of the HAPA in changing people's health behaviours, e.g., physical exercise, breast self-examination, seat belt use, dietary behaviours, and dental flossing; and its generalizability has been confirmed by Schwarzer (2008).
16157666|NCT01720966|Procedure|Liver resection|Liver resection performed for metastatic disease from colorectal carcinoma
16157667|NCT01720953|Other|Mentalization Based Therapy|Fifty female patients diagnosed with BPD will undergo a year of intensive Mentalization Based Therapy that is designed to target domains of BPD pathology. The patients will be assessed at baseline and every 6 months over the treatment period.
16157668|NCT01720940|Drug|continuous vancomycin infusion|24-hour continuous infusion of vancomycin
16157669|NCT01720940|Drug|intermittent vancomycin infusion|
16157670|NCT01720901|Drug|Icotinib|Icotinib will be administered 250 mg one time by month, 3 times per day.
16157671|NCT01720888|Other|BM-MSCs|Intracoronary implantation of bone marrow-derived mesencymal stem cells
16157672|NCT01720875|Drug|Vorinostat Velcade Dexamethasone|
16157673|NCT01720849|Drug|Fampyra|The will be given as per normal patient treatment plan
16157674|NCT01720836|Biological|Vaccine + PolyICLC|The vaccine will consist of 100 micrograms of MUC1 100mer peptide dissolved in 50 micro-liters of sterile saline, admixed with 500 micrograms of Hiltonol® in 250 microliters volume, for a total injection volume of 300 microliters.
16157675|NCT01720823|Device|home polysomnography (GETEMED)|
16157676|NCT01720823|Device|standard polysomnography (BRAINNET II)|
16157677|NCT01720797|Device|Micro-osteoperforation|Minimally invasive micro-osteoperforation procedure used to achieve rapid orthodontic tooth movement.
16157678|NCT01720797|Drug|Anesthestic|Topical or local anesthetic will be delivered in the area to be treated in accordance with standard practice.
16157679|NCT01720797|Other|Chlorhexidine|Prior to intervention subject will swish 5cc of chlorhexidine for one minute, twice. Following procedure Chlorhexidine rinses are to begin twice a day for a week.
16157680|NCT01720784|Dietary Supplement|Alginate dietary fiber|
16157681|NCT01720784|Dietary Supplement|Placebo|
16157682|NCT01720771|Dietary Supplement|probiotic tablet|Intake of one probiotic lozenge tablet per day
16157683|NCT01720771|Dietary Supplement|sugar pill|one tablet daily
16157684|NCT01720732|Behavioral|Lifeline NET|Short Version of Narrative Exposure Therapy
16157685|NCT01720719|Drug|atorvastatin|Oral atorvastatin 20mg, qd, for 24 weeks
16157686|NCT01720719|Drug|Vitamin E|Oral Vitamin E 300mg, qd, for 24 weeks
16157687|NCT01720706|Device|RFA Loosely wound thermal coil|"This new device uses radiofrequency energy to destroy kidney or liver tumours. It is called radiofrequency ablation.
~This type of energy is simply an alternating current that passes from a coil (electrode) into the tissue causing heating of the tissue in the vicinity of the electrode."
16157688|NCT01720693|Procedure|Hypoperfusion of renal artery|The renal artery is occluded to 30% of it's baseline, prior to kidney tumour removal
16157689|NCT01720680|Radiation|Low dose multislice CT thorax|"All patients will have 2 low dose multi-slice CT's at visit 2: one CT pre-dose and one CT 1 to 3 hours post-dose."
16157690|NCT01720680|Device|AlphaCore® device|All patients will receive a stimulation therapy of 90 seconds delivered by the AlphaCore.
16157691|NCT01720667|Drug|Intravenous levetiracetam|Intravenous load of levetiracetam (40 to 60 mg/kg) following identification of EEG confirmed neonatal seizure.
16157692|NCT01720667|Drug|Intravenous phenobarbital|Intravenous load of phenobarbital (20 to 40 mg/kg) following EEG confirmation of seizure activity load.
16157693|NCT01720654|Behavioral|EPT|Standardized partner notification counseling and provision of 5 partner treatment packets containing: Printed information on signs, symptoms, diagnosis, and treatment of gonorrhea and chlamydia as well as information on local testing/treatment resources; 400 mg Cefixime and 1g Azithromycin.
16157791|NCT01720030|Drug|Levosimendan|Verum therapy
16157694|NCT01720641|Behavioral|Internet|Referral and user instructions for Peru section of www.inspot.org partner notification website
16157695|NCT01720641|Behavioral|Referral Card|5 printed referral cards with information on syphilis signs, symptoms, diagnosis, treatment, and local resources.
16157696|NCT01720641|Behavioral|Internet and Referral Card|5 printed referral cards with information on syphilis signs, symptoms, diagnosis, treatment, and local resources; Referral and user instructions for Peru section of www.inspot.org partner notification website.
16157697|NCT01720628|Other|serum levels of angiogenin, bFGF, VEGF|Behçet's patients
16157698|NCT01720615|Drug|Propofol / Remifentanil|General anesthesia: Loss of consciousness and standard clinical practice
16157699|NCT01720615|Drug|Sevoflurane / Remifentanil|General anesthesia: Loss of consciousness and standard clinical practice
16157700|NCT01720602|Drug|vorinostat|Given PO
16157701|NCT01720602|Drug|anastrozole|Given PO
16157702|NCT01720602|Drug|letrozole|Given PO
16157703|NCT01720602|Drug|exemestane|Given PO
16157704|NCT01720602|Procedure|positron emission tomography|Correlative studies
16157705|NCT01720602|Radiation|F-18 16 alpha-fluoroestradiol|Correlative studies
16157706|NCT01720602|Radiation|fludeoxyglucose F 18|Correlative studies
16157707|NCT01720602|Other|laboratory biomarker analysis|Correlative studies
16157708|NCT01720589|Dietary Supplement|Melt (test oil)|
16157709|NCT01720589|Dietary Supplement|Corn oil (control)|
16157710|NCT01720576|Drug|REGN1033 (SAR391786)|
16157711|NCT01720576|Drug|Placebo|
16157712|NCT01720563|Drug|Astragalus polysaccharides 500 mg|PG2 (500 mg in 500 ml saline), t.i.w. via i.v. infusion for 2.5-3.5 hours during the CCRT
16157713|NCT01720563|Drug|Placebo|500 ml saline, t.i.w. via i.v. infusion for 2.5-3.5 hours during the CCRT
16157714|NCT01720563|Procedure|Concurrent chemoradiotherapy with PUL (cisplatin/tegafur plus uracil (UFT)/leucovorin) every 2 weeks|
16157715|NCT01720550|Drug|Astragalus Polysaccharides 500 mg|PG2 (500 mg in 500 ml saline), t.i.w. via i.v. infusion for 2.5-3.5 hours over 2 treatment cycles (8 weeks)
16157716|NCT01720550|Drug|Astragalus Polysaccharides 250 mg|PG2 (500 mg in 500 ml saline), t.i.w. via i.v. infusion for 2.5-3.5 hours over 2 treatment cycles (8 weeks)
16157717|NCT01720537|Biological|PF-05335810 Dose A|Single SC Injection
16157718|NCT01720537|Biological|PF-05335810 Dose B|Single Subcutaneous Injection(s)
16157719|NCT01720537|Biological|Placebo|Single Subcutaneous Injection(s)
16157720|NCT01720537|Biological|PF-05335810 Dose B|Single Intravenous Infusion
16157721|NCT01720537|Biological|Placebo|Single Intravenous Infusion
16157722|NCT01720537|Biological|PF-04950615 Dose A|Single Subcutaneous Injection(s)
16157723|NCT01720537|Biological|PF-04950615 Dose A|Single Intravenous Infusion
16157724|NCT01720537|Biological|PF-05335810 Dose C|Single Subcutaneous Injection(s)
16157725|NCT01720537|Biological|Placebo|Single Subcutaneous Injection(s)
16157726|NCT01720537|Biological|PF-05335810 Dose C|Single Intravenous Infusion
16157727|NCT01720537|Biological|Placebo|Single Intravenous Infusion
16157728|NCT01720537|Biological|PF-04950615|Single Subcutaneous Injection(s)
16157729|NCT01720537|Biological|PF-05335810 Dose D|Single Subcutaneous Injection(s)
16157730|NCT01720537|Biological|Placebo|Single Subcutaneous Injection(s)
16157731|NCT01720537|Biological|PF-05335810 Dose E|Multiple fixed dosages administered in subcutaneous injections, monthly for 3 months.
16157732|NCT01720537|Biological|PF-05335810 Dose D|Single Intravenous Infusion
16157733|NCT01720537|Biological|Placebo|Single Intravenous Infusion
16157734|NCT01720524|Drug|placebo|IV placebo or 0.9% sodium chloride or 10% dextrose. Infusion rate based on weight.
16157735|NCT01720524|Drug|iv sildenafil|loading dose of 0.1 mg/kg over 30 minutes followed by maintenance dose of 0.03 mg/kg/h. To infuse minimum 48 hours and maximum of 14 days.
16157736|NCT01720511|Dietary Supplement|Purple Rice|Incorporate one cup of purple rice into dishes to be consumed at lunch and dinner each day for 4 weeks (equivalent of 4 ounces of uncooked rice/day).
16157737|NCT01720511|Dietary Supplement|Brown Rice|Incorporate one cup of brown rice into dishes to be consumed at lunch and dinner each day for 4 weeks (equivalent of 4 ounces of uncooked rice/day).
16157738|NCT01720498|Drug|remifentanil|The effect site concentration of remifentanil
16157739|NCT01720485|Drug|Desloratadine + Prednisolone|1 tablet 3 times a day
16157740|NCT01720485|Drug|Dexchlorpheniramine + Betamethasone|1 tablet 3 times a day
16157741|NCT01720472|Genetic|Biomarker studies|
16157742|NCT01720459|Dietary Supplement|Micronized trans-resveratrol|
16157743|NCT01720459|Dietary Supplement|Placebo|
16157744|NCT01720446|Drug|semaglutide|Once weekly doses of 0.5 mg semaglutide after an initial dose escalation step of 0.25 mg as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin)
16157745|NCT01720446|Drug|semaglutide|Once weekly doses of 1.0 mg semaglutide after an initial dose escalation step of 0.25 mg followed by 0.5 mg dose escalation as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin)
16157746|NCT01720446|Drug|placebo|Once weekly doses volume-matched placebo, as an add-on to the standard-of-care treatment. Administered subcutaneously (s.c., under the skin).
16157747|NCT01720433|Procedure|intervention|The patient was placed in the Trendelenburg position (30°) and two manual lung inflations to a maximum pressure of 60 cm H2O for five seconds, with the valves on the operative ports fully open.
16157748|NCT01720420|Device|NobelReplace CC, NobelProcera Implant Bar|Implants titanium with conical connection, individualized titanium bar
16157749|NCT01720407|Drug|Imiquimod cream + surgery|Imiquimod (5 times per week) applied to and extending 1cm beyond the lesion for a period of 4 weeks (i.e. a total of 20 applications), followed by surgery performed four weeks after the last application of the topical treatment. If excision is intralesional, re-excision at 5mm will be performed within a few days (equivalent to 2-stage surgery).
16157750|NCT01720407|Drug|Placebo + surgery|Placebo (5 times per week) applied to and extending 1cm beyond the lesion for a period of 4 weeks, followed by surgery performed four weeks after the last application of the topical treatment. If excision is intralesional, re-excision of 5mm of clinically healthy tissue will be performed within a few days (equivalent to 2-stage surgery).
16157751|NCT01720394|Device|Cervical Ripening Balloon, Cook Medical Inc.|Application of the cervical ripening double-balloon (filled with 2x 80ml) on day 1.
16157752|NCT01720394|Drug|Dinoprostone|Application of Propess-vaginal-insert, (Dinoprostone 10mg - Ferring Arzneimittel Ges.m.b.H., 1100 Vienna, Austria) for labor induction on day 1-3 in therapy arm 2.
16157753|NCT01720342|Procedure|Aortic Valve Replacement surgery|Aortic Valve Replacement surgery of the native aortic valve with the Enable® aortic bioprosthesis.
16157754|NCT01720329|Dietary Supplement|Probiotics|Active comparator Arm. XXmls of XXX supplemented with XX of L. rhamnosus GG on a daily basis for six months
16157755|NCT01720329|Other|probiotic placebo|Placebo comparator arm -Participants randomized to placebo will receive XXmls of XXX G on a daily basis for 6 months.
16157756|NCT01720316|Drug|Glycine|Double-blind placebo controlled trial of glycine or placebo, followed by open-label glycine
16157757|NCT01720316|Drug|placebo|
16157758|NCT01720303|Drug|repaglinide|2 mg (tablets) before each main meal
16157759|NCT01720303|Drug|isophane human insulin|Injection s.c. (under the skin) at bedtime
16157760|NCT01720303|Drug|insulin|Injection s.c. (under the skin) twice daily
16157761|NCT01720290|Drug|repaglinide|Dose individually adjusted
16157762|NCT01720290|Drug|metformin|Dose individually adjusted
16157763|NCT01720290|Drug|metformin|Dose at 1000 mg/day
16157764|NCT01720277|Biological|HD Fluzone Vaccine|Nursing home residents over 65 years are allocated to receive high dose trivalent vaccine. Residents under 65 years are provided standard dose trivalent vaccine (TIV).
16157765|NCT01720277|Biological|SD Fluzone Vaccine|Nursing home residents are allocated to receive standard trivalent vaccine (TIV).
16157766|NCT01720264|Drug|Sitagliptin|Sitagliptin q 12 hours PO starting on Day -1 then given every 12 hours (total 10 doses) on Day 0, Day +1, +2 and Day +3.
16157767|NCT01720251|Drug|placebo|SC injections of placebo on days 1, 7, 14, 28 and 56
16157768|NCT01720251|Drug|AllerT low dose|SC injections of AllerT 25-50 micrograms on days 1, 7, 14, 28 and 56
16157769|NCT01720251|Drug|AllerT full dose|SC injections of AllerT 50-100 micrograms on days 1, 7, 14, 28 and 56
16157770|NCT01720238|Drug|Entecavir|0.5mg qd
16157771|NCT01720238|Drug|Lamivudine plus Adefovir Dipivoxil|Lamivudine:100mg qd Adefovir Dipivoxil:10mg qd
16157772|NCT01720225|Drug|Decitabine|20 mg/m2 by vein daily for 3 days (days 1-3) every 28 days.
16157773|NCT01720225|Drug|Azacitidine|75 mg/m2 subcutaneously or by vein daily for 3 days (days 1-3) every 28 days.
16157774|NCT01720212|Drug|YM178|oral
16157775|NCT01720199|Other|Diario della Salute (DDS)|"DDS is composed by
~tools for children and their parents on health and social and emotional well-being issues:
~a diary for teens telling the story of four same-age students (e.g. experimenting with risky behaviors, conflicting feelings and thoughts, need for independence and control),
~a diary for parents telling the experience of a mum and a dad with teenage children (e.g. problems in the relationship with teenage children, family conflict, parental disappointment, etc.);
~five highly-standardized interactive lessons (2-4 hours each) on health issues administered by previously trained teachers."
16157776|NCT01720186|Device|PET/CT 4D imaging in a synchronized mode centered on the thorax.|
16157779|NCT01720160|Device|BAROSTIM NEO® System|Implant procedure
16157780|NCT01720160|Other|Standard of care medical managment therapy for heart failure|Standard of care medical management therapy for heart failure (AHA/ACC guidelines), including drugs (determined by the patient's physician). Drug types include: Loop Diuretics, Thiazide Diuretics, Potassium-sparing Diuretics, Sequential Nephron Blockade, ACE Inhibitors, ARBs, ARNI, Aldosterone Antagonists, Beta Blockers and Hydralazine and Isosorbide Dinitrate.
16157781|NCT01720147|Drug|Quercetin (dietary supplement)|"Quercetin will be given orally on a twice a day schedule starting with weight adjusted dose for a maximum total daily dose of 1500 mg/day, for 4 months (16 weeks). Pharmacokinetics (PK) data will be analyzed after each cohort of 3 patients and will be used to optimize the dosing schedule (if required)for subsequent patients.
~An expansion cohort has been added to the study protocol. Up to 20 patients may be enrolled. The dose utilized will be the same as the max weight adjusted dose that showed biological activity in our last cohort of patients (subjects #10-12 from above)."
16157782|NCT01720121|Other|Printed, digital video disc|The three groups of patient received: 1)informative material in details about the cardiac catheterization provide by the researchers; 2)informative provide by a digital video disc; 3)the control group received the conventional informative provide by the nursing team.
16157783|NCT01720108|Drug|rivaroxaban and ASA|
16157784|NCT01720095|Drug|Niaspan|
16157785|NCT01720082|Procedure|Single incision laparoscopic appendectomy|A multiport device will be introducted through a 2-2.5 transumbilical incision. Retraction of the appendix would be performed with a forceps. The mesoappendix will be divided with bipolar or monopolar cautery. The appendix stump will be ligated with suture loop or with an endo-stapler. The specimen will be delivered within a plastic bag or in any protected way (without any contact with the abdominal wall) via the umbilical port. Any fluid will be suctioned and washing performed if required. Fascial defects will be closed with 2-O polydioxanone sutures and skin closed with 4-O non-absorbable sutures. No pelvic drain will be inserted. A three-band dressing will be applied in the end.
16157786|NCT01720082|Procedure|Multiport laparoscopic appendectomy|Three ports will be inserted as follows: One 10/12 umbilical port, one 5mm suprapubic (or right suprapubic)port, one 5mm or 10/12mm port in left iliac fossa (or left suprapubic). One additional trocar can be inserted following surgeons preference. Retraction of the appendix would be performed with a forceps. The mesoappendix will be divided with bipolar or monopolar cautery. The appendix stump will be ligated with suture loop or with an endo-stapler. The specimen will be delivered within a plastic bag or in any protected way (without any contact with the abdominal wall) via the umbilical port. Any fluid will be suctioned and washing performed if required. Fascial defects (10/12 trocars)will be closed with 2-O polydioxanone sutures and skin closed with 4-O non-absorbable sutures. No pelvic drain will be inserted. A three-band dressing will be applied in the end.
16157787|NCT01720069|Drug|VR506|VR506 inhalation powder delivered via a new dry powder inhaler device
16157788|NCT01720056|Drug|Verapamil|
16157789|NCT01720056|Drug|Kenalog 10|
16157790|NCT01720043|Drug|Velcade|Single dose of Velcade (1.0-1.3 mg/m2 dose)
16157792|NCT01720030|Drug|Conventional therapy|Placebo therapy to safeguard blinding
16157793|NCT01720017|Other|Preclinical Manikin Training|During the preclinical manikin training, each subject will perform 10 intubations in a manikin with a difficult airway simulated by swelling the manikin tongue and placing it in a cervical collar.
16157794|NCT01720017|Other|Inservice Training|Inservice training will include review of a product information handout and a video demonstration.
16157795|NCT01720004|Other|Repeated hands-and-knees positioning during labour|Details are in the Arm Description.
16157796|NCT01719991|Other|Nurse case management and self-management support|"Case management: The intervention will focus on four main components: (1) A thorough evaluation of the patient's needs and resources; (2) Establishing and maintaining a patient-centered, individualized service plan (ISP); (3) Coordination of services among partners; and (4) Self-management support for patients and their families.
~Self-management support: A standardized six-week program with interactive weekly group meetings led by two volunteer peer helpers (appointed trainers), who themselves have a chronic disease."
16157797|NCT01719978|Drug|3.6mL 2% Mepivacaine with 1:100,000 epinephrine|Local anesthetic with vasoconstrictor
16157798|NCT01719978|Procedure|Lower Third Molar Extraction|Lower Third Molar Extraction with LA + hyaluronidase (or placebo)
16157799|NCT01719978|Drug|Hyaluronidase|75RTU Hyaluronidase administration concomitant to the local anesthetic
16157800|NCT01719978|Drug|Placebo|1mL 0.9% saline administration concomitant to the local anesthetic
16157801|NCT01719965|Other|Interviews and Focus Group Discussions|
16157802|NCT01719952|Drug|Carbetocin|"IV carbetocin 100mcg, only in selected patient given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group.
~pitocin 5 IU also given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group."
16157803|NCT01719952|Drug|Oxytocin|5 IU given as an intravenous bolus over 30 seconds by the anaesthetist following clamping of the umbilical cord only in patient that has been randomized to this group.
16157804|NCT01719926|Drug|Indomethacin|3 times per day from 2 days before until 5 days after chemotherapy. Escalating dosage each cohort.
16157805|NCT01719913|Other|High gluten|Refined grain/ gluten rich diet : Participants consume more than 25g of gluten per day (estimated to correspond to a gluten intake around the 90th percentile in the population)
16157806|NCT01719913|Other|Low gluten|Poor gluten diet: Participants consume less than 5g gluten per day (estimated to correspond to a gluten intake below the 10th percentile in the population)
16157807|NCT01719900|Dietary Supplement|Pulse fibre|Yellow pea hull fibre incorporated into a biscuit at 5 g/serving.
16157808|NCT01719900|Dietary Supplement|Control|Control biscuit with no yellow pea hull fibre.
16157809|NCT01719887|Device|Conservative treatment|Conservative treatment with functional brace.
16157810|NCT01719887|Procedure|Operative treatment|Operative treatment with open reduction and internal fixation using 4,5mm locking compression plate.
16157811|NCT01719887|Other|Physiotherapy|Physiotherapy is arranged to both groups at 3 and 9 wks.
16157812|NCT01719874|Biological|TCN-032|
16157813|NCT01719874|Biological|Placebo (saline)|
16157814|NCT01719861|Drug|Desipramine HCL|Desipramine is a tricyclic antidepressant (TCA). All patients will start off with a 25 mg dose by mouth nightly (QHS), increasing weekly for 6 weeks. The target dose level at 6 weeks is 450 mg (maximum dosage) or the maximum tolerated dose (MTD) for each subject.
16157815|NCT01719848|Other|Measurements of parameters related with physical examinations for difficult airway prediction|
16157816|NCT01719835|Drug|Cyclophosphamide|750mg/m2 IV every 21 days
16157817|NCT01719835|Drug|Gemcitabine|1000mg/m2 IV Days 1, 8, 15 every 28 days
16157818|NCT01719835|Drug|Doxorubicin|50mg/m2 IV every 21 days
16157819|NCT01719835|Drug|Vincristine|1.4mg/m2 (max 2mg) IV every 21 days
16157820|NCT01719835|Drug|Prednisolone|100mg PO Days 1-5 every 21 days
16157821|NCT01719835|Drug|methylprednisolone|1000mg oral or IV Days 1-5 every 28 days
16157822|NCT01719835|Drug|Cisplatin|100mg/m2 IV Day 15 every 28 days
16157823|NCT01719822|Device|Yamax Digi-Walker CW-700|A pedometer with a daily step count target set by a physiotherapist.
16157824|NCT01719796|Procedure|Regional analgesia infusion|
16157825|NCT01719783|Biological|LAIV H5N2|2 doses provided intranasally
16157826|NCT01719783|Other|Placebo|2 doses of placebo provided intranasally
16157827|NCT01719770|Drug|rocuronium|continuous application of rocuronium 0,25mg/kg/h (blinded), in case of shivering episode bolus sodium-chloride (blinded)
16157828|NCT01719770|Other|placebo|continuous infusion of sodium-chloride (blinded), in case of shivering episode application of rocuronium 0,25mg/kg (blinded)
16157829|NCT01719757|Drug|Oxycodone/Naloxone|Twice daily
16157830|NCT01719744|Drug|ENMD-2076|
16157831|NCT01719731|Behavioral|Education|This group will receive the psychoeducation
16157832|NCT01719731|Behavioral|Non-Education|This group will not receive the psychoeducation
16157833|NCT01719718|Procedure|Closure of hernia defect.|Laparoscopic ventral hernia repair with closure of the hernia defect (mesh augmentation technique).
16157834|NCT01719718|Procedure|No closure of the hernia defect.|Conventional laparoscopic ventral hernia repair without closure of the hernia defect (defect bridging technique).
16157835|NCT01719705|Drug|Placebo|Ninety minutes before surgery, the parturients receive two identical placebo capsules
16157836|NCT01719705|Drug|Pregabalin 300 mg group|Ninety minutes before surgery, the parturients receive two capsules of pregabalin 150 mg
16157837|NCT01719705|Drug|Pregabalin 150 mg group|Ninety minutes before surgery, the parturients receive one capsule of pregabalin 150 mg and one placebo capsule
16157838|NCT01719692|Drug|Rituximab|
16157839|NCT01719679|Behavioral|School Located Vaccine (SLV) Program|A community vaccinator will administer vaccines to students whose parents consent for their child to participate
16157840|NCT01719666|Procedure|MPFL reconstruction and lateral retinaculum release|MPFL is performed with a standard technique using gracilis tendon. A tunnel is performed at the femoral part with a bioabsorbable screw fixation and 2 bundles with suture fixation at the patellar side
16157841|NCT01719666|Procedure|conventional surgery|conventional surgery: MPFL reconstruction
16157842|NCT01719653|Drug|MiraLAX|MiraLAX consumed as described in each arm.
16157843|NCT01719653|Other|Gatorade|Gatorade consumed as described in each arm.
16157844|NCT01719653|Drug|MoviPrep|MoviPrep consumed as described in each arm.
16157845|NCT01719653|Drug|SUPREP|SUPREP consumed as described in each arm.
16157846|NCT01719640|Drug|infusion of BMMSCs|infusion of BMMSCs
16157847|NCT01719640|Drug|infusion BMMNCs|infusion of BMMNCs
16157848|NCT01719640|Drug|insulin|intensive insulin care
16157849|NCT01719627|Drug|Maraviroc|Unique dose of Maraviroc 300mg
16157850|NCT01719627|Drug|TVD 300/200 QD|TVD 300/200 QD during 7 days
16157851|NCT01719627|Drug|Maraviroc|Unique dose of Maraviroc 600mg
16157852|NCT01719614|Drug|Metformin|Type=exact number, unit=mg, number=850, form=tablet, route=oral. Participants will receive single dose of metformin on Day 1 and Day 15.
16157853|NCT01719614|Drug|Rilpivirine|Type=exact number, unit=mg, number=25, form=tablet route=oral. Participants will receive 1 tablet of rilpivirine from Day 5 to Day 17.
16157854|NCT01719601|Drug|No intervention|This is an observational study. Immediate release tapentadol hydrochloride will be administered as per the recommended doses approved in Philippines. The recommended oral starting dose is 25 mg, 50 mg or 100 mg every 4 to 6 hours depending on the initial pain intensity and thereafter, the dose will be adjusted to maintain adequate analgesia with acceptable tolerability. The dosing regimen will be individualized according to the severity of pain being treated, the previous treatment experience, and the ability to monitor patients.
16157855|NCT01719588|Drug|No intervention|This is an observational study. Prolonged release tapentadol hydrochloride will be administered as per the recommended doses approved in Philippines. The recommended oral starting dose is 50 mg, 100 mg, 150 mg, 200 mg, or 250 mg every 12 hours, with or without food depending on the initial pain intensity and thereafter, the dose will be adjusted to maintain adequate analgesia with acceptable tolerability. The dosing regimen will be individualized according to the severity of pain being treated, the previous treatment experience, and the ability to monitor patients.
16157856|NCT01719575|Drug|Motilitone|
16157857|NCT01719575|Drug|Placebo|
16157858|NCT01719562|Procedure|Magnetic resonance imaging|Patients undergo MRI scans for left ventricular function, T1 myocardial signal, and aortic PWV at baseline, 3 months, and 24 months.
16157859|NCT01719562|Other|Physical Activity|Tailored aerobic exercise program onsite and at home.
16157860|NCT01719562|Other|Healthy Living|Healthy living presentations at a centralized meeting place and over the phone.
16157861|NCT01719562|Device|Cardiopulmonary Exercise Testing (CPET)|Performed on the treadmill using the Bruce or Modified Bruce protocol based on current fitness level.
16157862|NCT01719562|Other|Questionnaire Administration|A self-administered 13-item scale to assess fatigue in participants
16157863|NCT01719549|Drug|Dovitinib|"Study treatment: TKI258 single agent on a 5 days-on/2 days-off schedule
~Study drug: TKI258 capsule
~Dose: 500mg p.o. qd
~Every 3 weeks"
16157864|NCT01719536|Drug|Icotinib|Icotinib: 125 mg is administered orally three times per day.
16157865|NCT01719536|Drug|Chemotherapy|First-line chemotherapy: pemetrexed/cisplatin for 4 cycles. Maintenance treatment: pemetrexed.
16157866|NCT01719523|Drug|EPI-743|
16157867|NCT01719510|Other|Samples|"At time of delivery we will performed vaginal swabs in two groups: women tested positive for GBS at 35-37 weeks and women with risk of neonatal infection.
~For both groups:
~one swab for GBS detection by real-time PCR
~the second swab for GBS detection by conventional bacteriological techniques and sent to the bacteriology laboratory.
~For all women included will be achieved in the delivery room:
~To the mother: A blood sample of 5 ml at the time of the implementation of the IV line.
~A sampling of umbilical cord blood.
~Newborns of mothers included (group 1 and 2) will have a search for GBS (standard culture) in the stools and the pharynx prior to return home.
~For mothers, the collection of 3-5 ml of milk when breastfeeding."
16157868|NCT01719497|Drug|[C-11]OMAR|PET radioligand
16157869|NCT01719458|Drug|(S,S)-[11C]MRB|PET radioligand
16157870|NCT01719419|Drug|Placebo|Measured fatty food intake and appetite at a single lunch meal after the administration of modified sham feeding technique with placebo.
16157871|NCT01719419|Drug|Orlistat|Measured fatty food intake and appetite at a single lunch meal after the administration of modified sham feeding technique with orlistat.
16157872|NCT01719406|Behavioral|Intervention, behavioral lifestyle education|Twenty interactive weekly sessions that are scripted curriculum and peer led.
16157873|NCT01719380|Drug|LGX818|
16157874|NCT01719380|Drug|Cetuximab|
16157875|NCT01719380|Drug|BYL719|
16157876|NCT01719367|Drug|Atenolol|
16157877|NCT01719354|Other|Community Health center|Observation of the functioning and coordination of health care before discharge to own home.
16157878|NCT01719354|Other|Control|standard aftercare in hospital/mental health centers of District Psychiatric Service (DPS).
16157879|NCT01719328|Behavioral|Vinyasa yoga|
16157880|NCT01719315|Other|Acoustical slow wave induction|Brief tones (50 millisecond duration) at a frequency of 0.8 and 2 Hz, a rate that approximates the natural cellular oscillations of cortical neurons during sleep, will be played in blocks of 15-20 during non-rapid eye movement (NREM) sleep. Blocks of active acoustic slow wave induction will be followed by blocks of equal duration without induction, in order to make comparisons between stimulation periods (ON) and no stimulation periods (OFF). Tone intensity will be manually adjusted so as to be above an individual participant's auditory threshold during waking, but still quiet enough as not to awaken the subject from sleep. Sham slow wave induction will consist of auditory tones played prior to sleep, and during sleep of insufficient timing and intensity to alter slow wave activity.
16157881|NCT01719302|Drug|Gemcitabine|1500 mg/m^2 given days 1 and 15 of every 28 day cycle for a total of 4 cycles
16157882|NCT01719302|Drug|Docetaxel|50 mg/m^2 on days 1 and 15 of each 28 day cycle for a total of 4 cycles
16157883|NCT01719302|Drug|Pazopanib|Starting dose of 400 mg/day starting 72 hours after docetaxel/gemcitabine administration for 10 days (days 4-13 and 18-27) of each 28 day cycle for a total of 4 cycles. Dose will be increased by 200 mg/day for each cohort until the maximum tolerated dose is identified.
16157973|NCT01718691|Drug|SyB L-0501|A dose of 90 mg/m^2/day of SyB L-0501 is administered on Day 1 and Day 2 as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times.
16163552|NCT01675648|Drug|Diazepam|
16157884|NCT01719289|Behavioral|PROGRAVIDA|Women in the intervention group receive a program based on psycho-education and problem solving techniques, delivered by a nurse assistant at the women's homes. The program comprises 8 sessions, 6 during pregnancy and 2 after delivery. Intensity of depressive symptoms is assessed using the PHQ-9, at the beginning of the sessions. Women with severe depression are referred to the family doctor and are assessed for the need of antidepressant medication.
16157885|NCT01719276|Other|Graded Activity|The graded activity program to increase activity tolerance by performing individualized and submaximal exercises.
16157886|NCT01719276|Other|Supervised Exercises|The group will perform stretching exercises (gluteus maximus, hamstrings, triceps surae, lumbar paraspinal), strengthening muscles (rectus abdominus, obliques and lower rectus abdominis internal and external) and motor control exercises (muscle transversus abdominis and lumbar multifidus.
16157887|NCT01719263|Device|InterVapor® treatment plus Optimal Medical Therapy|Patients will be treated with the InterVapor System in 1 to 2 segments in the upper lobes of each lung (2 to 3 segments total). Patients will also receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema are published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary).
16157888|NCT01719263|Other|Optimal Medical Therapy|Patients will receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema are published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary).
16157889|NCT01719250|Drug|Buparlisib|Given PO
16157890|NCT01719250|Other|Laboratory Biomarker Analysis|Correlative studies
16157891|NCT01719250|Other|Questionnaire Administration|Ancillary studies
16157892|NCT01719237|Drug|Ropivacine and Chloroprocaine mixture|Chloroprocaine is added to Ropivacaine
16157893|NCT01719237|Drug|Ropivacaine only|Ropivacaine diluted with normal saline instead of chloroprocaine
16157894|NCT01719224|Procedure|elevated body position|45 degrees elevated upper body position
16157895|NCT01719224|Procedure|supine body position|non-elevated upper body position
16157896|NCT01719185|Drug|Phentermine and B12|
16157897|NCT01719185|Drug|Phentermine|
16157898|NCT01719172|Device|Veriset™ Hemostatic Patch|Topical Hemostat
16157899|NCT01719159|Drug|Rituximab|25 mg rituximab is injected intrathecally via an Ommaya reservoir once a week for 3 weeks. Patients are then followed for one year.
16157900|NCT01719146|Other|Specimen collection|At the beginning of each midweek hemodialysis session, a blood specimen (4 mL) will be drawn from the study subject. Out of this specimen a 1 mL serum sample will be frozen and stored. A 3 mL blood sample will be shipped overnight to WNERTA for laboratory testing.
16157901|NCT01719133|Drug|placebo|saline solution
16157902|NCT01719133|Drug|Histamine|positive control
16157903|NCT01719133|Drug|AllerT1|synthetic peptide T1
16157904|NCT01719133|Drug|AllerT2|synthetic peptide T2
16157905|NCT01719133|Drug|AllerT3|synthetic peptide T3
16157906|NCT01719133|Drug|AllerT4|synthetic peptide T4
16157907|NCT01719133|Drug|AllerT5|synthetic peptide T5
16157908|NCT01719133|Drug|mix of AllerT1-T2-T3|mix of peptides T1, T2 and T3
16157909|NCT01719133|Drug|mix of AllerT4-T5|mix T4-T5
16157910|NCT01719120|Behavioral|Cognitive-Behavioral Therapy|CBT for insomnia aims at changing dysfunctional cognitive beliefs and maladaptive behaviors contributed to the maintenance of insomnia. It involves 4 main components including behavioral, cognitive, educational, and relaxation treatments.
16157911|NCT01719107|Dietary Supplement|L. reuteri DSM 17938 chewable tablets|2 chewable tablets with breakfast for 4 weeks
16157912|NCT01719107|Dietary Supplement|Placebo chewable tablets|2 chewable tablets with breakfast for 4 weeks
16157913|NCT01719081|Procedure|Sacroiliac Joint Injection|Medication injected into the sacroiliac joint: Bupivicaine 3ml 0.25% with epinephrine 1/200,000 and Depo-Medrol 40mg.
16157914|NCT01719055|Device|neurostimulation system|Trial stimulation period, followed by permanent implant of a neurostimulation system for subjects with a positive trial outcome
16157915|NCT01719042|Drug|Zofran (8mg)|Subject will take 8mg of Zofran before taking antibiotic regimen and will record symptoms in a diary just before taking medication and two hours after taking medication every day for two weeks
16157916|NCT01719042|Dietary Supplement|Ensure|Subject will drink one cam of Ensure before taking antibiotic regimen and will record symptoms in a diary just before taking medication and two hours after taking medication every day for two weeks
16157917|NCT01719029|Other|Low-Carbohydrate/Higher Fat Diet|
16157918|NCT01719029|Other|High Carbohydrate/Low fat diet|
16157919|NCT01719016|Procedure|Cardiac PET, Coronary catheterization|"Patients would under go a Cardiac rest and stress PET scan and include the following drug administration:
~N-13 Ammonia radionuclide - Two doses, 10 mCi for rest, 20 mCi for stress
~Lexiscan - stress agent for PET scan
~Patients would also undergo Coronary catheterization including the following drug administration and device usage:
~Combowire to obtain pressure and flow readings on Combomap machine (Volcano Therapeutics, CA).
~Adenosine - stress agent during catheterization, 140 ug/Kg/min"
16157920|NCT01719003|Drug|Metformin 500 mg bid|Metformin 500 mg twice daily
16157921|NCT01719003|Drug|Metformin 1000 mg bid|Metformin 1000 mg twice daily
16157922|NCT01719003|Drug|Empagliflozin low dose qd|Empagliflozin low dose once daily
16157923|NCT01719003|Drug|Empagliflozin high dose qd|Empagliflozin high dose once daily
16157924|NCT01719003|Drug|Empagliflozin low dose bid|Empagliflozin low dose split twice daily
16157925|NCT01719003|Drug|Metformin 500 mg bid|Metformin 500 mg twice daily
16157926|NCT01719003|Drug|Empagliflozin high dose bid|Empagliflozin high dose split twice daily
16157927|NCT01719003|Drug|Empagliflozin low dose bid|Empagliflozin low dose split twice daily
16157928|NCT01719003|Drug|Metformin 1000 mg bid|Metformin 1000 mg twice daily
16157929|NCT01719003|Drug|Metformin 500 mg bid|Metformin 500 mg twice daily
16157930|NCT01719003|Drug|Metformin 1000 mg bid|Metformin 1000 mg twice daily
16157931|NCT01719003|Drug|Empagliflozin high dose bid|Empagliflozin high dose split twice daily
16157932|NCT01719003|Drug|Metformin 1000 mg bid|Metformin 1000 mg twice daily
16157933|NCT01719003|Drug|Empagliflozin high dose bid|Empagliflozin high dose split twice daily
16157934|NCT01718977|Other|Body Weight Supported Treadmill Training|BWSTT protocol will consist of training of individuals with complete SCI on a treadmill with a body weight support system. BWSTT is assisted by three individuals who participate in training. One trainer provides support at the hip, and one trainer at each leg. The participant will be fitted with a harness while seated in their wheelchair and then wheeled up a ramp to the treadmill. Cables attached to the harness will be used to hoist the participant into a standing position. Appropriate body weight support will be set according to the suggested Hocoma locomotor training protocol, in which weight is added until the participant is in dynamic support as indicated by the dynamic gauge on the treadmill. Dynamic support is usually indicated at the weight where participants do not have knee-buckling during a static standing position; however, this may not be observed in all severe, motor-complete SCI participants.
16157935|NCT01718977|Other|Arm Cycle Ergometry Training|"Arm Cycle Ergometry Training ACET will be performed on an arm-cycle ergometer against individually determined levels of resistance. Upright hand cuffs will be used so that the hand will be placed with the thumb pointing downward, and the ergometer will be positioned so that the arm never exceeded the height of the shoulder.
~The end objective is for the individual to complete 30-minutes of exercise in 2, 15-minute bouts. For safety reasons, stop criteria for individual sessions will be set and participants will have a rest period of 5 minutes and afterwards asked if they want to stop exercise, or resume the session."
16157936|NCT01718964|Drug|Cortisol 20 mg|
16157937|NCT01718964|Drug|Mannitol|Mannitol used as placebo
16157938|NCT01718951|Drug|golimumab|golimumab
16157939|NCT01718951|Drug|Pamidronate|pamidronate
16157940|NCT01718938|Drug|velusetrag dose 1|
16157941|NCT01718938|Drug|velusetrag dose 2|
16157942|NCT01718938|Drug|velusetrag dose 3|
16157943|NCT01718938|Drug|placebo|
16157944|NCT01718912|Drug|metronidazole-nystatin oral rinse|
16157945|NCT01718899|Biological|PVX-410|Approximately 10 patients will receive 6, bi-weekly, subcutaneous injections of a dose of PVX-410 in combination with an intramuscular injection of Hiltonol (Poly ICLC). Patients will complete a 12 week treatment phase and then will be followed for safety, immunogenicity and clinical response for 12 months
16157946|NCT01718886|Device|Obalon Gastric Balloon|
16157947|NCT01718873|Drug|Bevacizumab|5 mg/kg every 2 weeks for up to 24 weeks. After 24 weeks, those patients without disease progression will receive bevacizumab 7.5 mg/kg every 3 weeks until progression of disease or unacceptable toxicity.
16157948|NCT01718873|Drug|Oxaliplatin|85mg/m2 IV every 2 weeks for up to 24 weeks
16157949|NCT01718873|Drug|levo-folinic acid|200 mg/m2 IV before 5-fluorouracil infusion, every 2 weeks up to 24 weeks
16157950|NCT01718873|Drug|5-fluorouracil|400 mg/m2 IV bolus followed by 2400 mg/m2 IV infusion over 46 hours, every 2 weeks for up to 24 weeks (given in mFOLFOX-6 schedule)
16157951|NCT01718873|Drug|Capecitabine|1000mg/m2 by mouth, twice a day for 10 days, every 2 weeks for up to 24 weeks(given in mOXXEL schedule)
16157952|NCT01718860|Procedure|Quantitative measurement of neuromuscular transmission|Quantitative measurement of neuromuscular transmission with train-of-four watches.
16157953|NCT01718847|Drug|NOV120101 (Poziotinib)|16 mg PO once daily until disease progression or unacceptable toxicity development
16157954|NCT01718834|Biological|prophylactic peptide vaccine|synthetic peptide vaccine derived from HCV E1 and HCV E2 will be used for immunization of healthy volunteers
16157955|NCT01718834|Biological|therapeutic peptide vaccine|therapeutic peptide vaccine will immunize to HCV chronic HCV patients non responders to INF
16157956|NCT01718808|Drug|Cetuximab|Cetuximab 500 mg/m2 every second week (days 1, 15, 29, etc.) until progression or unacceptable toxicity
16157957|NCT01718808|Drug|Capecitabine|Capecitabine 1000 mg/m2 bid p.o. (750 mg/m2 if creatinine clearance 30-50 ml/min according to Cockroft-Gault formula, on days 1-14 every 3 weeks, restart on day 22
16157958|NCT01718795|Device|Bag-valve mask or laryngeal tube ventilation|"Interventions are either Bag-valve mask (BVM) or Laryngeal tube (LT) ventilation during CPR"
16157959|NCT01718782|Device|laryngeal mask Ambu AuraOnce|airway management and mechanical ventilation with laryngeal mask
16157960|NCT01718782|Device|laryngeal mask LMA Supreme|airway management and mechanical ventilation with laryngeal mask
16157961|NCT01718769|Other|questionnaire STAMP|Children will undergo an assessment using the STAMP Tool; a questionnaire including 3 questions with a summary score, according to which the nutritional risk level shall be determined. These children shall also undergo a complete dietician assessment in order to examine the validity of the STAMP Tool.
16157962|NCT01718756|Drug|Placebo|The placebo group received 12 hourly 20-mL i.v. boluses of 0.9% saline starting 20 min before induction of anaesthesia, followed by a constant infusion at 10 mL/h, for 48 hrs after surgery.
16157963|NCT01718756|Drug|Continuous infusion|"The continuous infusion group received 20-mL i.v. boluses of lornoxicam 0.8 mg/mL starting 20 min before induction of anaesthesia followed by a 12 hourly 20-mL i.v. boluses of 0.9% saline and a constant infusion at 10 mL/h of lornoxicam 0.13 mg/mL, for 48 hrs. after surgery"
16157964|NCT01718756|Drug|Scheduled|"The scheduled group received an 12 hourly 20-mL i.v. boluses of lornoxicam 0.8 mg/mL starting 20 min before induction of anaesthesia followed by a constant infusion at 10 mL/h of 0.9% saline, for 48 hrs after surgery (supplied by Xefo, JPI, Saudi Arabia), starting 20 min before induction of anaesthesia."
16157965|NCT01718743|Drug|Ixazomib Citrate|Given PO
16157966|NCT01718743|Drug|Lenalidomide|Given PO
16157967|NCT01718743|Other|Questionnaire Administration|Ancillary studies
16157968|NCT01718730|Device|Transcranial Magnetic Stimulation (TMS)|Single and paired-pulse TMS applied to the motor cortex will collect measures of cortical excitability and inhibition.
16157969|NCT01718730|Device|Magnetic Resonance Spectroscopy and Imaging|MRS/MRI Scans will examine glutamate concentrations in the motor cortex and anterior cingulate cortex.
16157970|NCT01718717|Other|Thoracic Epidural Analgesia (TEA)|
16157971|NCT01718717|Other|TEA followed by Intravenous morphine|
16157972|NCT01718704|Device|Viberect device|Men who begin using the Viberect device 3 days after Foley catheter removal on a daily (or at least 4 times a week) basis for 7-10 minutes in a relaxed setting with sexual thoughts or foreplay for one year. Viberect method can be performed by the person's sexual partner.
16158026|NCT01718301|Drug|Ribavirin|
16158027|NCT01718301|Drug|Peginterferon alfa-2a|
16158028|NCT01718301|Drug|Peginterferon alfa-2b|
16157974|NCT01718691|Drug|rituximab|A dose of 375 mg/m^2 of rituximab is administered on Day 1 (Day 0 in Cycle 1 only) as an IV drip infusion, followed by 26-day observation. This is 1 cycle (28 days), which will be repeated for a maximum of 6 times. From Cycle 2, rituximab will be coadministered with SyB L-0501 on Day 1. However, if the investigator or sub-investigator judges that the coadministration is difficult, rituximab may be administered on Day 0.
16157975|NCT01718678|Drug|Melatonin|it is kind of drug
16157976|NCT01718678|Drug|Placebo|It is Placebo
16157977|NCT01718652|Drug|Canagliflozin (JNJ-28431754)|One 300 mg capsule-shaped tablet taken orally (by mouth) on Days 1 through 8.
16157978|NCT01718652|Drug|Cyclosporine|Four 100 mg capsules (400 mg total dose) taken orally 30 minutes before the last dose of canagliflozin (JNJ-28431754) on Day 8.
16157979|NCT01718639|Device|IQP-LH-101 tablet|Oral medical device in the form of a chewable tablet
16157980|NCT01718639|Device|IQP-LH-101 liquid|Oral medical device in the form of a liquid
16157981|NCT01718639|Other|Placebo|
16157982|NCT01718626|Drug|S1+Docetaxel|Drug: S1 40-60mg, bid, days1-14, every 3 weeks Docetaxel 50mg/m2, day1, every 3 weeks, Patients will receive S1+Docetaxel until progression
16157983|NCT01718626|Drug|S1+Docetaxel followed by S1|Drug: S1 40-60mg, bid, days1-14, every 3 weeks Docetaxel 50mg/m2, day1, every 3 weeks,for 4 cycles; S1 40-60mg, bid, days1-14, every 3 weeks Patients will receive S1+Docetaxel followed by S1 until progression
16157984|NCT01718613|Drug|Vasopressin|Blinded Vasopressin will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement
16157985|NCT01718613|Drug|Norepinephrine|Blinded Norepinephrine will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement
16157986|NCT01718600|Behavioral|Neuropsychological testing|
16157987|NCT01718587|Procedure|stem cell transplantation through interventional procedure|interventional procedure once
16157988|NCT01718587|Drug|antiviral therapy (lamivudine, other antiviral drugs)|lamivudine, 100 mg per day (oral dose); or adefovir dipivoxil 10 mg per day (oral dose); or grace entecavir 0.5-1mg per day (oral dose); or behalftelbivudine 600 mg per day (oral dose).
16157989|NCT01718574|Other|Self-help book|Participants have 6 weeks to complete a 12 chapter self-help workbook. The workbook addresses: (i) The enhancement of a sense of personal control; and (ii) The learning of emotional and instrumental coping responses
16157990|NCT01718561|Procedure|SARI|The use of Modified Simplified Airway Risk Index (SARI) as preoperative airway assessment and assessment of risk factor for difficult mask ventilation. Registration in Danish Anesthesia Database
16157991|NCT01718548|Dietary Supplement|Cordyceps Sinensis (CS) and Lingzhi|
16157992|NCT01718548|Dietary Supplement|Tea and Flour|Placebo
16157993|NCT01718535|Device|Spartan FRX CYP2C19 Test System|
16157994|NCT01718522|Device|sensor augmented pump (SAP)|
16157995|NCT01718509|Drug|SPD489 (Lisdexamfetamine dimesylate)|50 or 70 mg administered orally, once-daily for up to 12 weeks
16157996|NCT01718509|Drug|Placebo|Administered once-daily, orally, for up to 12 weeks
16157997|NCT01718496|Drug|Morphine|patient with advanced COPD will randomly receive single dose Morphine to assess its effect on dyspnea and exercise tolerance
16157998|NCT01718496|Drug|Placebo|patients with advanced COPD on the other study arm will randomly receive Placebo
16157999|NCT01718483|Drug|SPD489 (Lisdexamfetamine dimesylate)|50 or 70 mg administered orally, once-daily for up to 12 weeks
16158000|NCT01718483|Drug|Placebo|Administered once-daily, orally, for up to 12 weeks
16158001|NCT01718470|Procedure|Endotracheal tube|Hemodynamic variables were recorded at 8 moments: baseline, in the operating room one minute before anesthetic induction; 5 minutes after the end of surgery before awakening (ETT group) and 1, 5, 10, 15, 30 and 60 min after extubation . The last blood pressure and heart rate measurements were taken in the postoperative recovery room.
16158002|NCT01718470|Procedure|LMA|Hemodynamic variables were recorded at 8 moments: baseline, in the operating room one minute before anesthetic induction; 5 minutes after the end of surgery before tube replacement (LMA group); and 1, 5, 10, 15, 30 and 60 min after LMA removal. The last blood pressure and heart rate measurements were taken in the postoperative recovery room.
16158003|NCT01718457|Device|Endobarrier|
16158004|NCT01718444|Drug|Progestin|
16158005|NCT01718444|Drug|Clomiphene Citrate|
16158006|NCT01718431|Other|test meal|
16158007|NCT01718431|Other|reference meal|
16158008|NCT01718418|Other|test meal|
16158009|NCT01718418|Other|reference|
16158010|NCT01718405|Other|Cognitive function after exercise test|The individual subjects will participate in 3 sessions of either aerobic exercise, resistance exercise or rest, in a random order. Before and after each session, the subject will take computerized cognitive tests.
16158011|NCT01718405|Genetic|Blood sample analysis|In the first evaluation session blood samples will be taken from each subject and will be analysed for genetic polymorphism.
16158012|NCT01718392|Behavioral|Training|
16158013|NCT01718379|Drug|Lenalidomide|Lenalidomide:10 mg per day during 21 days
16158014|NCT01718379|Drug|Epoetin beta|Epoetin beta: 60,000 Units/week.
16158015|NCT01718366|Drug|Deferasirox, Vitamin D and Azacitidine|association of Deferasirox (group 1: 5-10-15/mg/kg/day according to dose level group), Vitamine D (100000U/week) and Azacitidine (75 mg/kg/day day1-day7)
16158016|NCT01718353|Drug|DOCETAXEL (XRP6976)|Pharmaceutical form: Concentrate for solution for infusion Route of administration: Intravenous
16158017|NCT01718353|Drug|CABAZITAXEL (XRP6258)|Pharmaceutical form: Concentrate and solvent for solution for infusion Route of administration: Intravenous
16158018|NCT01718353|Drug|Prednisone|Pharmaceutical form: Tablet Route of administration: Oral
16158019|NCT01718340|Drug|Metformin|metformin tablet 500mg three time per day
16158020|NCT01718327|Drug|Sunitinib|sunitinib dose :37.5mg/day
16158021|NCT01718314|Drug|Sublingual Misoprostol|
16158022|NCT01718314|Drug|Lidocaine pump spray|
16158023|NCT01718314|Drug|Placebo (for Misoprostol)|Lactose filler, the pharmacy-produced pills identical to original misoprostol pill
16158024|NCT01718314|Drug|Placebo (for Lidocaine)|The pharmacy-produced sterile saline containing pump spray external characteristics identical to lidocaine pump spray
16158025|NCT01718301|Drug|boceprevir|
16158029|NCT01718288|Drug|iloprost|"The study, consists of two substudies, which deal with patients susceptible to medical therapy alone (substudy 1) or treated with classical surgical therapy (substudy 2).
~For each substudy, pts will be divided into two groups, one that will receive conventional treatments but not prostanoids, other conventional treatments with addition of iloprost.
~The 4 groups:
~1A. Pts unsuitable to surgical or endovascular vascular therapy: conventional treatment
~B. Pts unsuitable to surgical or endovascular vascular therapy: treatment with iloprost plus conventional treatment
~A. Pts suitable to vascular surgical or endovascular therapy: conventional treatment
~2B. Pts suitable to vascular surgical or endovascular therapy: treatment with iloprost plus conventional treatment"
16158030|NCT01718288|Drug|Standard Treatment (aspirin.....),|"The standard treatment, as has already been explained in the submission is the best treatment that the guidelines suggest for that specific type of patient with those complications and with stage 2b severe PAD.
~correction of concomitant risk factors, physical exercise, antiplatelet, standard heparin /low molecular weight heparin, hemorheological/vasodilators such as pentoxifylline/buflomedil, propionyl-L-carnitine, Defibrotide) but not prostanoids"
16158031|NCT01718249|Other|Implantable neurostimulation system|
16158032|NCT01718236|Drug|Rocuronium + sugammadex|Administration of rocuronium 1 mg/kg, intubation at decrease in Single Twitch to 10% of baseline event. by the disappearance of visible spikes event. in the 60th seconds after administration of muscle relaxants. Anesthesia with sevoflurane according to the MAC, neuromuscular blockade TOF count at 1-2.At the end of operation at PTC 1-2 sugammadex 4 mg/kg, at the TOF count 1-2, sugammadex 2 mg/kg, in the case of failure to achieve these values the anesthesiologist will wait until the minimum value of PTC 1-2 will be achieved. In can not intubate can not ventilate, and the failure of the introduction of laryngeal masks sugammadex 16mg/kg, immediately following the discovery of this fact and wait for the recovery of muscle strength. Time to recovery is recorded.
16158033|NCT01718236|Drug|Succinylcholine + Neostigmine|1mg/kg succinylcholine iodide, intubation after decrease in Single Twitch to 10% of baseline event. after the disappearance of visible fasciculation event. in the 60th seconds after administration of muscle relaxants. Anesthesia with sevoflurane according to the MAC, at the moment of 20-30% of the original value of Single Twitch rocuronium 0.3 mg / kg, maintaining TOF Count at 1-2.At the end of operation at TOF Count 1-2 atropine 0.01 mg/kg and neostigmine 0.03 mg/kg. If TOF not 1-2 wait.In can not intubate can not ventilate, wait for the spontaneous recovery. Time to recovery of muscle strength is recorded.
16158034|NCT01718223|Drug|photodynamic therapy|Undergo interstitial photodynamic therapy using temoporfin
16158035|NCT01718223|Procedure|therapeutic conventional surgery|Undergo surgical resection
16158036|NCT01718223|Other|laboratory biomarker analysis|Correlative studies
16158037|NCT01718223|Drug|temoporfin|Undergo interstitial photodynamic therapy using temoporfin
16158038|NCT01718210|Drug|GM-CSF medium|incubation of IVF embryos with a specific medium containing GM-CSF
16158039|NCT01718210|Drug|CONTROL|group of controls treated with a standard IVF medium
16158040|NCT01718184|Procedure|toric intraocular lens implantation|piggyback Sulcolflex toric intraocular lens implantation
16158041|NCT01718184|Procedure|Sulcoflex intraocular lens implantation|
16158042|NCT01718158|Biological|Peginterferon Lambda-1a|
16158043|NCT01718158|Biological|Peginterferon Alfa-2a|
16158044|NCT01718158|Drug|Ribavirin|
16158045|NCT01718158|Drug|Daclatasvir|
16158046|NCT01718158|Drug|Telaprevir|
16158047|NCT01718145|Drug|Daclatasvir|
16158048|NCT01718145|Drug|Asunaprevir|
16158049|NCT01718145|Drug|Ribavirin|
16158050|NCT01718145|Biological|pegIFNα-2b|
16158051|NCT01718145|Drug|Telaprevir|
16158052|NCT01718119|Drug|r-hCG|r-hCG(250mcg) injection subcutaneously
16158053|NCT01718106|Device|implantation of a bioabsorbable polymer DES|implantation in patients with long coronary artery stenosis of a single long or two shorter overlapped bioabsorbable polymer DES
16158054|NCT01718093|Drug|Sitagliptin|up to 50 mg twice a day
16158055|NCT01718093|Drug|Metformin|up to 1000 mg twice a day
16158056|NCT01718093|Drug|Sitagliptin + Metformin|up to 50/1000 mg twice a day
16158057|NCT01718067|Device|VAKÜM system|15 minutes, twice a day.
16158058|NCT01718067|Other|conventional manual ELTGOL technique|20 minutes twice a day
16158059|NCT01718054|Dietary Supplement|Vascular ready-to-use supplementary food|Daily vascular ready-to-use supplementary food containing protein, energy and fortified with 1 x recommended daily allowance(RDA) of vitamins and minerals except for folic acid = 1mg and with no iron fortificant included and fortified with arginine and citrulline amino acids
16158060|NCT01718054|Dietary Supplement|Regular Ready-to-use supplementary food|Daily ready-to-use supplementary food containing protein, energy and fortified with 1 x RDA vitamins and minerals except for folic acid = 1mg and with no iron fortificant included.
16158061|NCT01718054|Drug|Chloroquine|
16158062|NCT01718041|Drug|Experimental: VRS-317|Active treatment arm
16158063|NCT01718028|Other|Propylene glycol 0.6% ocular emulsion|
16158064|NCT01718028|Other|Sodium chloride 0.9% saline solution|
16158065|NCT01718002|Behavioral|Educational video|The patient was asked to execute the technique used daily oral hygiene that, with the sequence, movements and technical procedures for its implementation evaluated and recorded an instrument to analyze the steps of oral hygiene. Subsequently, patients watched the video prepared individually in the ward where they were interned. After this step, the patient demonstrated again the procedure for oral hygiene. At this point the researcher also observed the sequence, movements and technical procedures used to analyze the steps of oral hygiene, using the same instrument for such employee initially.
16158066|NCT01717976|Behavioral|DISPO ED|primary care based nurse telephone support
16158067|NCT01717963|Drug|Naltrexone intramuscular suspension|A standard dosage of 380 mg / month of naltrexone intramuscular suspension will be administered
16158068|NCT01717963|Drug|Buprenorphine-naloxone|Buprenorphine-naloxone is administered daily and provided in accordance with existing guidelines for OMT in Norway (treatment-as-usual).
16158102|NCT01717716|Dietary Supplement|water with sucrose|
16158103|NCT01717703|Dietary Supplement|Water|
16158104|NCT01717703|Dietary Supplement|Fruit drink|
16158105|NCT01717703|Dietary Supplement|Cola|
16158106|NCT01717703|Dietary Supplement|1% chocolate milk|
16158069|NCT01717950|Biological|Na-APR-1 (M74)/Alhydrogel®|The Na-APR-1 (M74) candidate vaccine contains the recombinant Na-APR-1 (M74) protein expressed by Nicotiana plants. Purified Na-APR-1 (M74) was subsequently adsorbed onto aluminum hydroxide gel (Alhydrogel®) and suspended in a solution containing 10 mM imidazole, 150 mM sodium chloride and 0.3% Empigen BB, with pH 7.4 ± 0.1. The final concentration of Na-APR-1 (M74) in the drug product is 0.1 mg/ml, whereas that of Alhydrogel® is 0.8 mg/ml. Different doses of Na-APR-1 (M74) will be delivered by injecting different volumes of the 0.1 mg/ml Na-APR-1 (M74) preparation.
16158070|NCT01717950|Biological|Gluco-Pyranosylphospho-Lipid A Aqueous Formulation|GLA-AF contains a synthetic monophosphoryl lipid A (MPL) molecule that has Toll-Like Receptor-4 agonist activity. MPL is itself derived from the lipopolysaccharide (LPS) of Salmonella minnesota, a natural TLR4 agonist that is pyrogenic and can induce toxic shock. LPS, and more specifically, its lipid A component, has long been known for its strong adjuvant effects; however, its high toxicity has precluded its use in a vaccine formulation.
16158071|NCT01717937|Procedure|Phase variance optical coherence tomography (PV-OCT)|Subjects will undergo standard, noninvasive optical coherence tomography (OCT) scans with an FDA-approved OCT device, and the data gathered by this device will be transferred to a separate computer for processing using novel software. This software is capable of utilizing the existing data to generate phase variance OCT images. There are no known risks associated with OCT scans.
16158072|NCT01717924|Procedure|peri-operative chemotherapy|Usual treatment strategy for gastric adenocarcinoma
16158073|NCT01717924|Procedure|Surgery first|strategy with a surgical procedure first, without the usual peri-operative chemotherapy
16158074|NCT01717911|Drug|Insulin|In the insulin therapy group (Humulin-N), subjects were instructed in the techniques for insulin injection and home capillary glucose monitoring. Two third daily dose was administrated before breakfast and one third at bedtime. Insulin doses were titrated every 3 days to achieve target fasting plasma glucose values between 90 and 130 mg/dl.
16158075|NCT01717911|Drug|Metformin|The titration of metformin was used 500 mg for an adjust unit in splitting dose with the same target to the maximum daily dose of 2550 mg (1000 mg twice daily and then 850 mg tid).
16158076|NCT01717911|Drug|Sitagliptin|The subjects treated with sitagliptin started with 100 mg before breakfast once daily. The dosage was fixed as 100mg per day. Decreased by 50mg if fasting blood glucose was <70mg /dl, discontinued the study if blood glucose was still <70mg/dl under sitagliptin 50mg per day.
16158077|NCT01717898|Drug|BEZ235|BEZ235 - 200 mg, 300 mg, or 400 mg; po, BID. BEZ235 will be supplied in 200 mg, 300 mg, and 400 mg sachets packaged in boxes.
16158078|NCT01717898|Drug|Prednisone|10/mg po daily. Prednisone can be modified at the investigator's discretion, but should not be discontinued.
16158079|NCT01717898|Drug|Abiraterone acetate|1000 mg, po. Abiraterone Acetate is supplied in 250 mg white tablets, four tablets are to be taken with a full glass of water on an empty stomach once daily.
16158080|NCT01717872|Device|Laryngoscope blade|The POGO score will be used to assess the percent of the glottis that can be seen with each of the blades lifting and not lifting the epiglotis
16158081|NCT01717859|Drug|Tocilizumab|All subjects will start at 4mg/kg. After 3 months, if DAS28 > 3.2, dosage will be escalated to 8 mg/kg.
16158082|NCT01717846|Drug|Group 1 or Orencia treated group|Group 1 subjects will be given subcutaneous abatacept, 125 mg once a week upto 6 months.
16158083|NCT01717846|Other|Group 2 (DMARDS treated group)|Arm 2 or Group 2 is for RA patients who are being treated wth non-biologic DMARDS who, with their doctor, have decided that they will not be receiving treatment with Abatacept in the next six months. These patients will not receive the study drug abatacept.
16158084|NCT01717833|Procedure|NEMS|NEMS sessions on both lower extremities (quadriceps and peroneus longus) simultaneously
16158085|NCT01717833|Procedure|Sham|Sham sessions of neuromuscular electrical stimulation
16158086|NCT01717820|Dietary Supplement|Freeze-dried whole-grape powder|Participants are provided the equivalent of two servings per day of freeze-dried grape powder in a double-blind, placebo controlled, randomized design to determine the impact of the phytochemical, resveratrol, on biomarkers of adipose metabolism and bone metabolism.
16158087|NCT01717807|Other|C11-Erlotinib PET/CT|
16158088|NCT01717794|Procedure|Thunderbeat technology|
16158089|NCT01717794|Procedure|Standard bipolar electrosurgery|
16158090|NCT01717781|Procedure|Thunderbeat technology|
16158091|NCT01717781|Procedure|Standard bipolar electrosurgery|
16158092|NCT01717768|Drug|TSX-002|TSX-002 are capsules with testosterone as the active ingredient.
16158093|NCT01717755|Other|Intra-arterial treatment|IA therapy has to be initiated within 6 hours of estimated time of basilar artery occlusion. If an appropriate thrombus or residual stenosis is identified, the choice of IA strategy wil be made by the treating neurointerventionalist. Choice of therapy depends on local approval and experience. If IA thrombolysis is the chosen strategy, a maximum of 22 mg of IA rt-PA or 1.500.000 Units of Urokinase may be given. Stenting is allowed in the presence of a high-grade vertebral artery stenosis or occlusion hampering adequate endovascular access to the basilar artery and in case of a residual high-grade basilar artery stenosis. The use of any other treatment strategy depends on local approval and experience, and is only allowed after prior approval of the steering committee.
16158094|NCT01717742|Drug|TPA (Tissue Plasminogen Activator)|Intrapleural administration of tPA 4 mg in 10 ml (≤10 kg) or 20 ml (>10 kg) normal saline once daily for 3 days
16158095|NCT01717742|Drug|DNase|Intrapleural administration of DNase 5 mg diluted to 10 ml (≤10 kg) or 20 ml (>10 kg) normal saline once daily for 3 days
16158096|NCT01717742|Other|Placebo|Intrapleural administration of normal saline 10 ml (≤10 kg) or 20 ml (>10 kg)
16158097|NCT01717729|Procedure|Radiofrequency Ablation|For RFA, we used a commercially available system (RF 2000; Radio Therapeutics, Mountain View, Calif) and a needle electrode with a 15-gauge insulated cannula that had 10 hook-shaped expandable electrode tines with a diameter of 3.5 cm at expansion (LeVeen; Radio Therapeutics).The radioactivity per seed ranged from 0.5 to 0.6 millicuries (mCi)
16158098|NCT01717729|Radiation|iodine|The 125I seeds (0.8 mm in diameter and 4.5mm in length) were enclosed in a NiTinol capsule (China Institute of Atomic Energy, Beijing). These seeds could produce 27.4-31.5 keV X-ray and 35.5 Kev γ ray, with a half-life of 59.6 days. The radioactivity per seed ranged from 0.5 to 0.6 millicuries (mCi).
16158099|NCT01717716|Dietary Supplement|water with Sucralose|
16158100|NCT01717716|Dietary Supplement|water with HFCS|
16158101|NCT01717716|Dietary Supplement|water with glucose|
16158107|NCT01717690|Drug|CHG antiseptic body cleanser|The intervention consists of daily bathing of all patients (MRSA-positive and MRSA-negative) on the intervention unit with CHG.
16158108|NCT01717677|Procedure|radical prostatectomy|
16158109|NCT01717677|Radiation|percutaneous radiation therapy|
16158110|NCT01717677|Radiation|permanent seed implantation|
16158111|NCT01717677|Procedure|Active Surveillance|
16158112|NCT01717664|Drug|RHB-104|95 mg clarithromycin, 45 mg rifabutin, and 10 mg clofazimine
16158113|NCT01717638|Biological|1 dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine|0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, single dose
16158114|NCT01717638|Biological|2 doses of Meningococcal (group B) multicomponent recombinant adsorbed vaccine|0.5 mL of Meningococcal (group B) multicomponent recombinant adsorbed vaccine, Intramuscular, two doses, two months apart
16158115|NCT01717625|Drug|Montelukast|a leukotriene D4 receptor antagonist; sodium salt is the active compound; structure in first source
16158116|NCT01717612|Drug|Thrombin|Among the thrombin group, the injection site was also aimed at the bleeding varices or varices with red color signs or at the most prominent varices. The injected agents consisted of lyophilized human Thrombin in calcium chloride solution containing thrombin 500IU/ml). (Floseal, Baxter Healthcare Corporation, CA, Hayward, USA)
16158117|NCT01717612|Drug|Histoacryl|The injection site was aimed at the bleeding varices or varices with red color signs or at the most prominent varices.
16158118|NCT01717599|Drug|Diclofenac|Diclofenac 90mg, 2ml/A, IM(intramuscular) injection immediately after procedure of ERCP
16158119|NCT01717599|Drug|normal saline|normal saline 2ml/A, IM(intramuscular) injection immediately after procedure of ERCP
16158120|NCT01717586|Drug|Pravastatin|Comparison of different drug dosages. Women will be instructed to take a pravastatin pill everyday starting the day of randomization and ending the day of delivery. The women will be divided into three cohorts. Each cohort will receive one of the following doses of pills: 10mg or 20mg or 40mg.
16158121|NCT01717586|Drug|Placebo|Women will be instructed to take a placebo pill daily beginning the day of randomization and ending the day of delivery.
16158122|NCT01717573|Procedure|Deferred stenting|
16158123|NCT01717573|Procedure|Conventional treatment|
16158124|NCT01717560|Other|Collaborative, multidisciplinary, integrated care|"Collaborative, multidisciplinary, integrated care for hepatitis C
~multidisciplinary model that combines expert care in five domains: (a) antiviral pharmacotherapy for HCV infection; (b) substance abuse treatment; (c) psychiatric evaluation and treatment; (d) primary medical care; and (e) intensive, client-centered, case management."
16158125|NCT01717547|Behavioral|Yoga-based treatment|
16158126|NCT01717534|Dietary Supplement|heat-treated lactobacilli or placebo|Daily supplement of sachet with 1 g of powder over a 5 months period.
16158127|NCT01717508|Behavioral|Cognitive Behavioral Therapy|12 sessions of cognitive behavioral therapy
16158128|NCT01717482|Drug|Metformin|
16158129|NCT01717482|Other|Placebo Comparator|Standard of Care Observation
16158130|NCT01717469|Device|Left ventricular pacing through coronary sinus tributaries (Attain StarFix)|Left ventricular pacing in patients with bradycardia
16158131|NCT01717469|Device|Right ventricular pacing (Medtronic)|Conventional right ventricular pacing in patients with bradycardia.
16158132|NCT01717456|Other|Education|Patient and caregiver will be taught which muscles are used in continence and defecation through the use of a training manual and anatomical drawings.
16158133|NCT01717456|Dietary Supplement|Fiber supplements|Patients and caregivers will be taught to use fiber supplements to normalize stool consistency if patient reports diarrhea or constipation. Fiber supplements will be in the form of Metamucil beginning with 3.4 grams per day and increasing up to 13.6 grams per day if needed to control stool consistency.
16158134|NCT01717456|Drug|Laxatives or anti-diarrheals|"Miralax at a dose of one packet (17 grams) daily may be used for constipation if unresponsive to fiber. Dose may be titrated up to two packets (34 grams) daily if needed.
~Imodium at a starting dose of 2 mg/day may be used for diarrhea if unresponsive to fiber. Dose of Imodium may be titrated down to 1 mg or up to 4 mg if needed."
16158135|NCT01717456|Behavioral|Pelvic floor muscle exercises|Patients will be taught how to perform pelvic floor muscle contractions during digital rectal examination by a nurse. They will be asked to squeeze 100 times daily.
16158136|NCT01717456|Behavioral|Tips on how to prevent fecal incontinence|"Examples of behavioral tips are Walk, don't run to the toilet and Squeeze before you lift objects or sneeze."
16158137|NCT01717456|Behavioral|Daily diary|Both groups will keep a daily diary, but amount of detail differs: Active comparator group records bowel accidents, bowel movements, Bristol Stool ratings of stool consistency, number of times they do pelvic floor exercises, study medications, and comments for the nurse to read. Placebo comparator group records only bowel accidents, bowel movements, and Bristol Stool scores.
16158138|NCT01717456|Other|Protective pads or garments|In both groups, patients will be permitted to use pads or protective garments to avoid embarrassment. They will be told that fecal leakage that is stopped by a pad or protective garment should still be recorded as fecal incontinence.
16158139|NCT01717417|Device|miniscrew|
16158140|NCT01717417|Device|TPA|
16158141|NCT01717404|Drug|Mexiletine|6-day treatment period during which the medication will be taken orally with an initial dose of: 200 mg every 8 hours for 3 doses on day 3, increasing to 300 mg every 8 hours on days 4 and 5 (6 doses), and increasing further to 400 mg every 8 hours on days 6-8 if no telemetry changes and no dose limiting side effects
16158142|NCT01717391|Drug|fluorothymidine F 18|A patient-specific bone marrow map will be designed from the pre-therapy FLT PET/CT imaging. A highly conformal radiation plan will be designed to spare active bone marrow.
16158143|NCT01717352|Behavioral|Weight Loss Education|
16158144|NCT01717352|Behavioral|Sleep and Eating Routine|
16158145|NCT01717339|Other|Sleep Study|
16158146|NCT01717326|Drug|Grazoprevir|100 mg tablet orally QD
16158147|NCT01717326|Drug|Elbasvir|Part A: 20 or 50 mg capsule orally QD Parts B, C, and D: 50 mg capsule orally QD
16158148|NCT01717326|Drug|Placebo to Elbasvir|Placebo to Elbasvir 20 or 50 mg capsule, orally, once daily for 12 weeks to maintain blind (Part A only)
16158149|NCT01717326|Drug|Ribavirin|Oral capsules BID at a total daily dose from 800 to 1400 mg based on participant weight
16164601|NCT01667107|Drug|Posaconazole|
16158150|NCT01717313|Drug|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week.
16158151|NCT01717313|Drug|Placebo to Omarigliptin|Placebo to omarigliptin capsule administered orally once a week
16158152|NCT01717313|Drug|Metformin|If necessary, participants may have glycemic rescue therapy initiated with open-label metformin during Phase A of the study. Participants in the placebo treatment group who were not rescued with open-label metformin during Phase A will receive blinded metformin (starting at 500 mg orally twice daily with up-titration to 1000 mg orally twice daily) in Phase B. Participants in the omarigliptin treatment group who were rescued with open-label metformin in Phase A will continue open-label metformin during Phase B of the study.
16158153|NCT01717313|Drug|Placebo to metformin|During Phase B of the study, participants in the omarigliptin treatment group who did not initiate glycemic rescue therapy during Phase A will receive placebo to metformin for 30 weeks (Phase B of the study).
16158154|NCT01717313|Drug|Glimepiride|If necessary during Phase B of the study, participants will initiate open-label glimepiride as glycemic rescue therapy
16158155|NCT01717300|Drug|Anacetrapib 100 mg|100 mg tablet, oral, once daily for 24 weeks
16158156|NCT01717300|Drug|Placebo for anacetrapib 100 mg|Placebo tablet, orally, once daily for 24 weeks
16158157|NCT01717300|Drug|Anacetrapib 25 mg|25 mg tablet, oral, once daily for 24 weeks
16158158|NCT01717300|Drug|Placebo for anacetrapib 25 mg|Placebo tablet, orally, once daily for 24 weeks
16158159|NCT01717287|Drug|Raltegravir Film-coated Tablet|
16158160|NCT01717287|Drug|Raltegravir Chewable Tablet|
16158161|NCT01717287|Drug|Other Anti-Retroviral Therapy|At baseline, the investigator selected the other anti-retroviral therapies to be used in combination with raltegravir based on current treatment guidelines, the participant's treatment history, and prior anti-retroviral resistance testing
16158162|NCT01717274|Procedure|Hot saline irrigation|The surgical field is flushed with 20 cc of hot saline (45-50 degrees Celsius) at five minutes intervals. This is in contrast to the standard of care, room temperature (20-25 degrees Celsius) saline irrigation.
16158163|NCT01717261|Radiation|Single Pre-Operative Radiation Therapy|Dose escalation: 3 patients will receive 15 Gy in a single fraction. The following 3 patients will receive 18 Gy. The final 4 patients will receive 20 Gy.
16158164|NCT01717248|Drug|GCS-100|GCS-100 is a modified citrus pectin that binds to and sequesteres circulating galectin-3, a protein that has been shown to promote organ disease (fibrosis).
16158165|NCT01717235|Drug|Ropinirole hydrochloride CR Tablets 2mg|Ropinirole is an orally administered non-ergoline dopamine agonist. Ropinirole is indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.
16158166|NCT01717222|Drug|Intraperitoneal Lignocaine|Patients will receive 100 ml of 0.2% lignocaine
16158167|NCT01717222|Drug|Intravenous Lignocaine|Intravenous group patients will receive 1.5mg/kg of lignocaine as bolus dose at induction and 2mg/kg/hour as continuous infusion until one hour after surgery
16158168|NCT01717209|Drug|Nitric Oxide|inhaled nitric oxide
16158169|NCT01717209|Drug|Prostacyclin|inhaled prostacyclin
16158170|NCT01717196|Other|different volume aspiration|comparison between diagnostic yield of FNA on solid pancreatic masses performed with different aspiration volume (10 and 20ml) and without aspiration.
16158171|NCT01717183|Device|Urgo 310 3113|URGO 310 3113 dressing may be changed every 2 to 4 days, and left in place for up to 7 days, depending on the level of exudate and the wound condition
16158172|NCT01717183|Device|Placebo URGO 310 3113 dressing|
16158173|NCT01717170|Drug|Tocilizumab|Tocilizumab (4 mg/kg or 8 mg/kg)
16158174|NCT01717157|Drug|Treatment A: DUROGESIC (8.4 mg fentanyl)|One DUROGESIC transdermal patch containing 8.4 mg of fentanyl applied on the skin for 72 hours.
16158175|NCT01717157|Drug|Treatment B: Transdermal System-Concept 1 (6.2 mg fentanyl)|One transdermal system-concept 1 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
16158176|NCT01717157|Drug|Treatment C: Transdermal System-Concept 2 (6.2 mg fentanyl)|One transdermal system-concept 2 patch containing approximately 6.2 mg of fentanyl applied on the skin for 72 hours.
16158177|NCT01717157|Drug|Treatment D: Transdermal System-Concept 3 (7.1 mg fentanyl)|One transdermal system-concept 3 patch containing approximately 7.1 mg of fentanyl applied on the skin for 72 hours.
16158178|NCT01717157|Drug|Treatment E: Transdermal System-Concept 4 (11.0 mg fentanyl)|One transdermal system-concept 4 patch containing approximately 11.0 mg of fentanyl applied on the skin for 72 hours.
16158179|NCT01717144|Behavioral|therapeutic education program|The educational program consisted of both individual and collective educational consultations with a therapeutic education nurse
16158180|NCT01717131|Procedure|Surgery for standard axillary node dissection|
16158181|NCT01717131|Other|No axillary lymph node dissection|No surgery on axillary lymph node
16158182|NCT01717118|Biological|Bivalent Vaccines|
16158183|NCT01717118|Biological|Tetravalent Vaccine|
16158184|NCT01717079|Procedure|Sham rTMS|120 pulses 0.2Hz
16158185|NCT01717079|Procedure|rTMS|120 pulses 0.2Hz
16158186|NCT01717066|Drug|the ginsenoside Rg3|
16158187|NCT01717066|Drug|Placebo|
16158188|NCT01717053|Drug|Abiraterone acetate|1000 mg orally once a day for 6 months.
16158189|NCT01717053|Drug|Androgen deprivation|LHRH analog (at discretion of treating physician) will be administered over 6 months (for example, leuprolide acetate 22.5mg IM or goserelin acetate 10.8mg SC given every 3 months for 2 doses).
16158190|NCT01717053|Radiation|Radiation Therapy|Daily (Monday-Friday) for 8 weeks, final dose of 75-80 Gy
16158191|NCT01717053|Drug|Prednisone|5 mg tablet once daily for 6 months.
16158192|NCT01717040|Drug|Pioglitazone|Pioglitazone will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
16158193|NCT01717040|Drug|Placebo|Placebo will be initiated at a starting daily dose of 15 mg. After 7 days, the dose may be increased to 30 mg and after 35 days may be increased to a maximum of 45 mg per day.
16158194|NCT01717027|Drug|Oxycodone|One capsule of 40 mg PF-00345439 Formulation A, single dose, taken whole and under fed conditions
16158195|NCT01717027|Drug|Oxycodone|One capsule of 40 mg PF-00345439 Formulation J, single dose, taken whole and under fed conditions
16158196|NCT01717027|Drug|Oxycodone|One capsule of 40 mg PF-00345439 Formulation K, single dose, taken whole and under fed conditions
16158197|NCT01717027|Drug|Oxycodone|One capsule of 40 mg PF-00345439 Formulation J or K, single dose, chewed and under fasted conditions
16158198|NCT01717014|Device|Covidien Radial Reload Stapler with Tri-Staple Technology|Case series of patients already selected to undergo an open LAR or proctosigmoidectomy using the Radial Reload Stapler
16158199|NCT01716975|Drug|EVP-6124|Arms 1, 2
16158200|NCT01716975|Drug|Placebo|Arm 3
16158201|NCT01716962|Other|Infusion of 6% tetrastarch for a total of 500 ml|
16158202|NCT01716949|Radiation|Radiotherapy|45 up to 50.4 Gy; daily dose 1,8 Gy, 5 days per weeks
16158203|NCT01716949|Procedure|Hyperthermia|10 sessions, therapeutic time 60 min
16158204|NCT01716949|Drug|5-Fluorouracil|250 mg/m^2/d as continuous i.v. infusion on d1-14, 22-35 (may be preplaced by Capecitabine)
16158205|NCT01716949|Drug|Capecitabine|1650 mg/m^2/d oral intake d1-14, 22-35 (may be replaced by 5-Fluorouracil)
16158206|NCT01716949|Drug|Oxaliplatin|50 mg/m^2/d as 2-hour bolus infusion on d2, 9, 23, 30
16158207|NCT01716923|Biological|S-303 Red Blood Cells (RBCs) - Test|
16158208|NCT01716923|Biological|Conventional, untreated red blood cells (RBCs) - Control|
16158209|NCT01716910|Dietary Supplement|Combination of Lactobacillus acidophilus NCFM and cellobiose|
16158210|NCT01716897|Drug|E2609|
16158211|NCT01716871|Device|neurocryostimulation with Duo-cryo® device|organized in the morning and in the evening during 3days. The gaz is sprayed with Duo-cryo® device on dry skin over the ankle using a slow, regular, sweeping movement. The tip of the nozzle is kept 15 to 20 cm away from the skin. Neurocryostimulation is applied to patients for a duration of one minute by a trained staff
16158212|NCT01716871|Device|cryotherapy with Cold pack® or ice-cubes pack|"Patients receive 2 controlled applications a day (one in the morning and one in the evening) of cryotherapy with Cold pack® or ice-cubes pack (with average dimensions of 5 cm by 8 cm) to the injury site for a duration of 20 minutes. Furthermore, the patients are instructed to do 2 more applications of the ice-pack during the daytime to follow the usual recommendations.
~The first and last sessions of each day must be supervised by the medical care Unit to insure standardized data collection for each group."
16158213|NCT01716858|Dietary Supplement|Sulforaphane-rich Broccoli Sprout Extract|
16158214|NCT01716832|Behavioral|Mindfulness Walking|Mindful walking in a small group twice a week for 60 minutes within 4 weeks.
16158215|NCT01716819|Other|Urine sample|dosages on one spot and 24h collection
16158216|NCT01716819|Other|Blood sample|dosages
16158217|NCT01716819|Other|Assessment of sleep apnea syndrome|
16158218|NCT01716819|Other|Electrocardiogram|
16158219|NCT01716819|Other|Glucose tolerance test|
16158220|NCT01716819|Other|Echocardiography|
16158221|NCT01716819|Other|cardiac and abdominal magnetic resonance imaging|
16158222|NCT01716819|Other|Ambulatory blood pressure monitoring|
16158223|NCT01716819|Other|Echotracking|
16158224|NCT01716819|Other|Pulse wave velocity|
16158225|NCT01716819|Other|Composition of body mass by Dual x-ray absorptiometry|
16158230|NCT01716793|Drug|Ara-C|"Intermediate dose during induction phase to remission.
~High-dose during consolidation phase in patients with favorable cytogenetics."
16158231|NCT01716793|Other|Autologous transplantation|"In patients with normal karyotype and one cycle of chemotherapy to achieve complete remission.
~In patients with other cytogenetics without HLA-Identical sibling."
16158232|NCT01716793|Other|Allogeneic HLA-identical sibling transplantation|"Patients without favorable or normal karyotype(and one course to CR).
~Patients with normal karyotype who need two cycles of chemotherapy to achieve CR, and other cytogenetics."
16158233|NCT01716793|Other|CD34+ selection|In allotransplants, it is performed a CD34+ cell selection of peripheral blood stem cell transplantation.
16158234|NCT01716780|Other|Intervention|"Patients allocated to the intervention group will undergo prospective, proactive, integrated, structured pain treatment according to recent guidelines on cancer pain care"
16158235|NCT01716767|Other|Menthol|The gel will be applied at 2.5 ml per 500 cm2 to the hand, wrist and forearm
16158236|NCT01716767|Other|Placebo|The gel will be applied at 2.5 ml per 500 cm2 to the hand, wrist and forearm
16158237|NCT01716754|Drug|QGE031|QGE031 was supplied as 120 mg liquid in vial per 1 mL
16158238|NCT01716754|Drug|Omalizumab|Omalizumab was supplied as 150 mg lyophilisate in vial
16158239|NCT01716754|Drug|Placebo|Placebo to QGE031 and Omalizumab was supplied as QGE031 0 mg in vial per 1 mL
16158240|NCT01716741|Other|Enzyme analysis|
16158241|NCT01716728|Other|enzyme analysis|
16158242|NCT01716715|Drug|Cabozantinib S-malate|Given PO
16158243|NCT01716715|Other|Laboratory Biomarker Analysis|Correlative studies
16158244|NCT01716715|Drug|Paclitaxel|Given IV
16158245|NCT01716702|Behavioral|Couples Prostate Cancer Support Group|"The participants in the experimental group will receive 6 weekly online intervention sessions with a professional facilitator. In addition participants will be asked to complete relationship-enhancement exercises and readings in between sessions.
~In the experimental group, participants will be asked to complete questionnaires at three time points: 1)pre-intervention (baseline) 2) post-intervention (7 weeks), and 3) post intervention (13 weeks).
~In the waitlist group, participants will not participate in the support group. Participants will be asked to complete questionnaires at three time points: 1)pre-intervention (baseline) 2) post-intervention (7 weeks), and 3) post intervention (13 weeks)."
16158246|NCT01716689|Drug|oral cyclophosphamide|50mg daily
16158247|NCT01716676|Other|Telemedicine CPAP monitoring (webpage and televisit)|
16158248|NCT01716676|Other|Standard CPAP monitoring|
16158249|NCT01716663|Device|Catheter Ablation|NAVISTAR® THERMOCOOL® SF Catheter with the CARTO® 3 System and the SOUNDSTAR® Ultrasound Catheter (with the CARTOSOUND® Software Module)
16158250|NCT01716637|Biological|Etanercept|
16158251|NCT01716637|Dietary Supplement|Curcum.Luteol.Theaflav.Lip.Acid,FishOil,Quercet.,Resveratr.|
16158252|NCT01716624|Drug|Oxybutynin|standard oral therapy
16158253|NCT01716624|Drug|Botulinum Toxin A injection|10 units/kg injected into the detrusor muscle using cystoscopy
16158254|NCT01716611|Drug|Tolvaptan|15 - 60 mg/day for 28 days
16158255|NCT01716611|Drug|placebo|
16158256|NCT01716598|Device|IPS System|TLD Therapy will be achieved bronchoscopically.
16158257|NCT01716585|Drug|ABT-450/r/ABT-267, ABT-333|ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
16158258|NCT01716585|Drug|Ribavirin|Capsule (double-blind treatment period), tablet (open-label treatment period)
16158259|NCT01716585|Drug|Placebo for ABT-450/r/ABT-267|Tablet
16158260|NCT01716585|Drug|Placebo for ABT-333|Tablet
16158261|NCT01716585|Drug|Placebo for ribavirin|Capsule
16158262|NCT01716572|Drug|Erythromycin|Intravenous 250 mg of erythromycin, single-dose, 30 minutes before the endoscopy
16158263|NCT01716572|Procedure|gastric lavage|gastric lavage by nasogastric tube with 1 liter of saline before the endoscopy
16158264|NCT01716546|Drug|Pazopanib|
16158265|NCT01716533|Procedure|Blood sampling|Blood sampling will be done at Day 0, at Day 14, at recurrence (if applicable) and at end of follow-up.
16158266|NCT01716533|Other|Stool sample collection|Stool samples will be collected around Day 0, around Day 14 and at recurrence (if applicable).
16158267|NCT01716520|Device|Umeclidinium/Vilanterol 62.5/25 mcg|Umeclidinium/Vilanterol 62.5/25 mcg once daily in the morning via novel dry powder inhaler (NDPI)
16158268|NCT01716520|Device|Umeclidinium 62.5 mcg|Umeclidinium 62.5 mcg once daily in the morning via novel dry powder inhaler (NDPI)
16158269|NCT01716520|Device|Vilanterol 25 mcg|Vilanterol 25 mcg once daily in the morning via novel dry powder inhaler (NDPI)
16158270|NCT01716507|Procedure|Retinal Detachment repair|Comparing 23 gauge vs 20 gauge pars plana vitrectomy.
16158271|NCT01716481|Other|Mesenchymal stem cell|intravenous transplantation of autologous mesenchymal stem cells expanded with autologous serum
16158272|NCT01716468|Other|Ketogenic Diet|modified ketogenic diet
16158273|NCT01716455|Drug|SSP-004184|
16158274|NCT01716442|Drug|Rituximab|Per dose: Rituximab 375 mg/m2 (max.500mg/day). efficacy monitored by CD19 cell count. If CD19 cells are not depleted, second or third doses are given at 2-3 weeks interval.
16158275|NCT01716442|Drug|Placebo|
16158276|NCT01716429|Behavioral|Vegan diet|Vegan dietary approaches for weight loss
16158277|NCT01716429|Behavioral|Low calorie diet|Reduced calorie diet for weight loss
16158278|NCT01716416|Drug|Pazopanib|
16158279|NCT01716416|Drug|Cetuximab|
16158280|NCT01716403|Biological|Diagnostic: protocol designed to evaluate one or more interventions aimed at identifying a disease or health condition|
16158281|NCT01716390|Dietary Supplement|Drink that contains plant stanols|
16158282|NCT01716390|Dietary Supplement|Placebo drink|
16158283|NCT01716377|Drug|Venlafaxine|Sixty patients who present following a minor motor vehicle collision will be randomized to venlafaxine vs. placebo, and the ability of venlafaxine to decrease acute and persistent musculoskeletal neck pain will be assessed.
16158284|NCT01716364|Biological|Anti-LeY- scFv-CD28-ζ vector,.|
16158285|NCT01716351|Behavioral|Adapted Yoga Intervention for Implantable Cardioverter Defibrillator (ICD) Recipients|A weekly 80-minute standardized, repeatable adapted Yoga program designed for recipients of Implantable Cardioverter Defibrillators, including a 30-minute home practice CD.
16158286|NCT01716338|Drug|Glyburide|
16158287|NCT01716338|Drug|Placebo|
16158288|NCT01716325|Other|Self-management weight loss plan endorsement.|Self-management weight loss plan endorsement.
16158289|NCT01716325|Other|Conventional|Weight loss, comparator - no ICT support; conventional live workshops for weight loss
16158290|NCT01716312|Drug|Omalizumab|For each subject, treatment with omalizumab will start with a loading dose of 600 mg followed by a maintenance dose of 300 mg every 4 weeks. The study drug will be administered as a subcutaneous injection. On Week 0 and Week 16 the medication or placebo will be administered to subjects via 4 subcutaneous injections; the remaining weeks 2 injections will be administered.Subjects will be given written directions on dealing with adverse reactions. They will also receive an Epi-Pen before discharge and instructions on how to use it.
16158291|NCT01716299|Other|application of a confirmation test|Addition of confirmation test to serial testing algorithm, including dilution test
16158292|NCT01716299|Other|application of a confirmation test|use of rapid confirmation test
16158293|NCT01716286|Dietary Supplement|low fat vs. essence yoghurt|
16158294|NCT01716273|Other|Granulated Sugar|30 grams of granulated sugar is used to cover the wound area and this is held in place using a dry dressing pad , bandage and tape.
16158295|NCT01716273|Other|Debridement Dressing|1 Aquacel or Sorbsan dressing will be put over the wound, and held in place with a dry dressing pad, bandage and tape.
16158296|NCT01716260|Drug|Chloroquine|
16158297|NCT01716260|Drug|Primaquine|
16158298|NCT01716247|Other|Mammography (CESM) and MRI|The study consists of the addition of a single contrast enhanced digital mammography examination (CESM) to the routine screening of a woman at increased risk for breast cancer who is also having a breast MRI. Breast MRIs will be read by the radiologist reading breast MRIs on any given day. CESM is a dedicated system, derived from a standard digital mammography unit modified to deliver the dual or multiple energy exposures and visualization of combined images after IV contrast administration. If the patient is having her routine mammogram within 30 days of her MRI, CESM can replace that mammogram Patients will be randomly assigned to one of the radiologists trained to interpret CESM. That radiologist will read the CESM blinded to the results of the breast MRI.This process will be monitored by the research assistant No radiologist will read both the breast MRI and CESM on the same patient.
16158299|NCT01716234|Drug|Posaconazole 12 mg/kg/day BID|Posaconazole oral suspension 12 mg/kg/day divided into 2 doses (BID) (maximum 800 mg/day)
16158300|NCT01716234|Drug|Posaconazole 18 mg/kg/day BID|Posaconazole oral suspension 18 mg/kg/day divided into 2 doses (BID) (maximum 1200 mg/day)
16158301|NCT01716234|Drug|Posaconazole 18 mg/kg/day TID|Posaconazole oral suspension 18 mg/kg/day divided into 3 doses (TID) (maximum 1200 mg/day)
16158302|NCT01716234|Drug|Posaconazole 12 mg/kg/day TID|Posaconazole oral suspension 12 mg/kg/day divided into 3 doses (TID) (maximum 800 mg/day)
16158303|NCT01716221|Drug|bupropion & Citalopram|
16158304|NCT01716221|Drug|Bupropion & Placebo|
16164602|NCT01667107|Drug|Calogen®|
16158305|NCT01716221|Drug|Placebo & Citalopram|
16158306|NCT01716221|Drug|Placebo & Placebo|
16158307|NCT01716208|Drug|Ofatumumab + Fresh Frozen Plasma|
16158308|NCT01716195|Radiation|Induction Chemotherapy followed by Response Adapted Chemoradiation|All patients receive induction chemotherapy with 2 cycles of paclitaxel and carboplatin followed by response adapted, de-escalated chemoradiation. Patients with a complete or partial response will receive 54 Gy with concurrent paclitaxel and patients with stable disease will receive 60 Gy with concurrent paclitaxel.
16158309|NCT01716169|Device|Helicoll|Helicoll Collagen I Wound Dressing
16158310|NCT01716169|Device|Standard of Care Dressings|Standard of Care wound dressings (e.g. Vaseline gauze)
16158311|NCT01716156|Drug|Grazoprevir|Grazoprevir, tablet, orally, 100 mg, once per day for 12 or 24 weeks, depending on Arm assignment
16158312|NCT01716156|Drug|Ribavirin|Ribavirin capsules, orally, twice per day, at a total daily dose from 800 to 1400 mg based on participant weight
16158313|NCT01716143|Procedure|radiofrequency catheter ablation|
16158314|NCT01716117|Device|Surpass Flow Diverter|Treatment of an intracranial aneurysm involves the placement of a specially designed metallic mesh tube in a vessel in the brain where an aneurysm is located. The device looks like a fishnet sock with both ends open. Each device is delivered through a small catheter (a long, flexible tube). The catheter containing the device is inserted and advanced into a vessel in the brain. The device is then placed in the brain vessel by releasing it from the catheter. Once the device is placed inside the brain vessel, it is intended to reinforce the area of the vessel that is weakened and bulging (the aneurysm), and to cause blood to flow down the vessel and away from the aneurysm while allowing blood in the aneurysm to clot. This procedure is called an endovascular aneurysm treatment because the device is delivered through the blood vessels.
16158315|NCT01716104|Drug|Afalaza|Safety and Efficacy
16158316|NCT01716104|Drug|Placebo|Safety and Efficacy
16158317|NCT01716091|Procedure|irrigation in the peritoneal cavity|irrigation in the peritoneal cavity after uterine wall closed at cesarean
16158318|NCT01716052|Drug|placebo|Lactulose
16158319|NCT01716052|Drug|Ibuprofen|
16158320|NCT01716039|Drug|MTX 12.5|"once weekly oral dosing with MTX 12.5 mg (n=40) two weeks prior to the initiation of adalimumab. Randomization will be stratified by disease activity (modified Mayo Score ≤9 or >9).
~Subjects will receive 18 weekly doses of MTX in addition to doses of adalimumab"
16158321|NCT01716039|Drug|MTX 25|"once weekly oral dosing with MTX 25 mg (n=40) two weeks prior to the initiation of adalimumab. Randomization will be stratified by disease activity (modified Mayo Score ≤9 or >9).
~Subjects will receive 18 weekly doses of MTX in addition to doses of adalimumab"
16158322|NCT01716039|Drug|Adalimumab|Subjects will receive 18 weekly doses of adalimumab
16158323|NCT01716026|Drug|Bevazizumab intravitreal injection|Intravitreal injection of bevacizumab
16158324|NCT01716013|Device|BondEase|topical skin adhesive
16158325|NCT01716013|Procedure|CWCD|traditional closure methods of sutures, staples or adhesive strips
16158326|NCT01716000|Other|vaginal gel imaging|Imaging of vaginal gel distribution using two investigational techniques (low coherence interferometry and fluorimetry).
16158327|NCT01716000|Behavioral|computer aided self interview|Questionnaire to gather the perceptions and preferences of the subject with respect to the vaginal gel.
16158328|NCT01715987|Drug|Tenofovir Disoproxil Fumarate|300mg, oral daily for two years
16158329|NCT01715987|Drug|Entecavir|0.5mg oral daily for two years.
16158330|NCT01715974|Drug|G-CSF group|60 micrograms/day of G-CSF from the day of embryo transfer through the day of beta HCG test
16158331|NCT01715974|Drug|CONTROL|saline infusion every day from the day of embryo transfer through the day of beta HCG test
16158332|NCT01715961|Procedure|anthropometric measurement|To attest the muscular strength: hand grip test, balance test, up and go test
16158333|NCT01715948|Device|CROS hearing aid|Participants were randomly assigned to be fitted with the CROS hearing aid either at the end of the first visit or at the end of the second visit. They were given a 2-week trial with the CROS and asked to refrain from wearing their BAHD during that time. At the end of the first visit, four participants were fitted with the CROS hearing aid and were subsequently tested with this device on their second visit, at which time they were instructed to use the BAHD for the next 2 weeks. This protocol was reversed in the other four participants, with testing after each device experience. Both devices were compared on head shadow effect reduction, speech perception measures in quiet and in noise, self-assessment questionnaires, and daily diaries.
16158334|NCT01715948|Device|Bone-anchored hearing device (BAHD)|All participants had received BAHD implantation prior to the study. They were randomly selected to continue wearing their BAHD for 2 weeks following the end of the first visit or the end of the second visit. Both devices were compared on head shadow effect reduction, speech perception measures in quiet and in noise, self-assessment questionnaires, and daily diaries.
16158335|NCT01715935|Drug|Everolimus|everolimus, 10 mg PO daily. Before nephrectomy: 6 continuous weeks of treatment and one week of rest After nephrectomy: 4 weeks courses (for metastatic patients only)
16158336|NCT01715922|Drug|Fluconazole|Induction treatment for 2 weeks: Fluconazole (1600mg/j) Consolidation treatment for 8 weeks: fluconazole (800 mg/j)
16158337|NCT01715922|Drug|Flucytosine|Flucytosine (100 mg/kg/j) for 2 weeks
16158338|NCT01715922|Procedure|lumbar punctures|lumbar punctures to control intracranial pressure
16158339|NCT01715909|Drug|Oseltamivir|Participants will receive standard dose (30 to 75 milligrams [mg]) or triple standard dose (90 to 225 mg) of oseltamivir orally daily for up to maximum of 20 days. Standard dose of oseltamivir according to weight (except infants): 30 mg twice daily for </= 15 kilograms (kg) body weight participants; 45 mg twice daily for 15 to 23 kg body weight participants; 60 mg twice daily for 23 to 40 kg body weight participants; and 75 mg twice daily for greater than (>) 40 kg body weight participants. Standard dose for infants is 3 mg/kg.
16158340|NCT01715896|Biological|Golimumab 50 mg|Participants received alternating doses of golimumab 50 mg (Weeks 0, 4, 8, 12, 16, 20, and 24) and placebo matched to mavrilimumab (Weeks 2, 6, 10, 14, 18, and 22) injections subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
16158341|NCT01715896|Biological|Mavrilimumab 100 mg|Participants received Mavrilimumab 100 mg injection subcutaneously every 2 weeks for 24 weeks in combination with stable dose of methotrexate (7.5 to 25 mg per week) through oral or parenteral route.
16158342|NCT01715883|Drug|Sodium Nitrite|Same as the details in Arm Description.
16158343|NCT01715870|Behavioral|Life style and food habits questionnaire|
16158344|NCT01715844|Dietary Supplement|L-citrulline|Patients will take 3-gr of L-citrulline/day for 7 days
16158345|NCT01715831|Drug|DMARDs|DMARDs may be added to the tocilizumab treatment in any visit, at the discretion of the investigator, according to the local prescription information and participant's tolerance. Study protocol does not specify any particular DMARD.
16158346|NCT01715831|Drug|Tocilizumab|Tocilizumab will be administered at 8 mg/kg IV dose every 4 weeks for 104 weeks
16158347|NCT01715818|Drug|Placebo|matching aleglitazar placebo tablet orally daily
16158348|NCT01715818|Drug|aleglitazar|150 mcg orally daily
16158349|NCT01715805|Drug|Cariprazine|Cariprazine capsules 1.5 to 4.5 mg/day
16158350|NCT01715805|Drug|Placebo|Dose-matched placebo capsule once per day
16158351|NCT01715805|Drug|Antidepressant Therapy (ADT)|ADT such as bupropion, citalopram, desvenlafaxine, duloxetine, escitalopram, fluoxetine, sertraline, venlafaxine, paroxetine or vilazodone as prescribed by the physician.
16158352|NCT01715792|Other|Data collection|Data extraction from the CPRD GOLD and HES, and additional data obtained from complementary information provided by the GPs using a standardised questionnaire.
16158353|NCT01715779|Drug|Eltrombopag|Eltrombopag exposure
16158354|NCT01715753|Dietary Supplement|Protein supplementation|> 30g of high quality protein will be achieved three times a day by subjects in this group, with all or predominantly all from animal source and 60-70% of animal protein from beef.
16158355|NCT01715753|Behavioral|Diet counseling and group education lessons|Individual and group diet counseling to achieve a >10% weight loss
16158356|NCT01715740|Drug|Chinese Herbal Medicine (CHM)|Each CHM capsule, weighing 500mg, consists of XFS 250 mg and QSFFT 250 mg.
16158357|NCT01715740|Drug|Placebo|Encapsulated powder with similar taste, color, odor to intervention Chinese herbal medicine
16158358|NCT01715714|Drug|Statin Recapture Therapy|Given 12h and 2h before CABG
16158359|NCT01715714|Drug|Placebo|Given 12h and 2h before CABG.
16158360|NCT01715701|Procedure|Paravertebral nerve blockade|Paravertebral nerve blockade using ropivacaine, intercostal nerve blockade using saline and PCA using hydromorphone or morphine.
16158361|NCT01715701|Procedure|Intercostal nerve blockade|Intercostal nerve blockade using ropivacaine, simulated paravertebral nerve blockade and PCA using hydromorphone or morphine.
16158362|NCT01715701|Procedure|Patient Controlled Analgesia|Simulated paravertebral nerve blockade, intercostal nerve blockade using saline and PCA using hydromorphone or morphine.
16158363|NCT01715688|Drug|Alkalinized lidocaine|Administration of alkalinized lidocaine in the endotracheal tube cuff
16158364|NCT01715688|Drug|Saline|Administration of saline in the endotracheal tube cuff
16158365|NCT01715675|Dietary Supplement|Plant stanol enriched soy-based yoghurt|Plant stanol enriched soy-based yoghurt
16158366|NCT01715675|Dietary Supplement|Soy-based yoghurt without added plant stanols|Soy-based yoghurt without added plant stanols
16158367|NCT01715662|Device|Wii.n.Walk|Subjects will be trained using Nintendo Wii Fit (commercial fitness gaming software) for 40-minute sessions, 3x/week for 4 weeks. The intervention will initially be conducted in the clinic with a group of 3 participants and will graduate to in-home sessions starting from week 2.
16158368|NCT01715662|Device|Wii Big Brain|Subjects in the control group will be trained using Wii Big Brain Academy Degree program which is a low-cost commercially available gaming software to improve cognitive function. The intervention will initially be conducted in the clinic with a group of 3 participants and will graduate to in-home sessions starting from week 2.
16158369|NCT01715649|Behavioral|Patient education, self-monitoring of blood glucose and remote patient monitoring of blood glucose|In the intervention arm you will test your blood glucose 2 times a day (before and after a meal, activity or other event) using the glucose meter provided to you for use in this study and connect it to the Telehealth Unit. Every week the study team will review your blood glucose levels through the remote patient monitoring secure portal and send you a reminder through the Telehealth Unit with suggestions based on your blood glucose patterns. Once every month a study nurse will call you to review your blood glucose goals and discuss how you may be able to make changes in your health behaviors to improve your blood glucose levels. The study team will work with you to help you make changes to your behaviors that may improve your blood glucose.
16158370|NCT01715636|Drug|Eviplera = emtricitabine 200mg, rilpivirine 25mg, tenofovir 245mg|
16158371|NCT01715623|Biological|a blood sample|Dosage of Ig
16158372|NCT01715610|Drug|Clavulin|Patients will be randomized to the antibiotic or placebo arm via a random number generator.
16158373|NCT01715610|Drug|Randomization to Placebo|Patient's post-drainage of antibiotics will receive placebo and not receive antibiotics
16158374|NCT01715610|Drug|Clindamycin|Patients will be randomized to the antibiotic or placebo arm via a random number generator
16158375|NCT01715597|Drug|ascorbic acid|ascorbic acid 2g in normal saline 500ml IV start 30min before the operation and infusion for 2 hour
16158376|NCT01715597|Drug|Normal saline|normal saline 500ml IV
16158377|NCT01715584|Other|Sevoflurane/oxygen/air/nitrous oxide|Patients in each arm will be randomized to receive either: 50 per cent oxygen, air, and sevoflurane or 50% nitrous oxide, oxygen and sevoflurane. They will then cross over to the other gas mixture. The depth of each the anesthetic will be varied from 0.8 MAC (minimum alveolar concentration) to 1.6 MAC in 0.2 MAC steps. Hemodyamic variables will be measured at each anesthetic concentration (average of five measurements). Time will be allowed for anesthetic agent equilibration. Paralysis and analgesia using rocuronium and fentanyl will be provided to ensure patients do not move at low (less than 1.0 MAC. It is estimated the time for the cross over experiment will be approximately six hours.
16158378|NCT01715571|Device|Viberect|"Men will be asked to perform vibratory stimulation of the penis in the privacy of their home, while focused on sexual thoughts for approximately 7-10 minutes (depending on erectile response) for 3 times a week, one day apart, throughout the four week period. Men can perform the stimulation once daily, as long as each session is more than 24 hours apart.
~Men will record device use and intercourse attempts after device use in a diary."
16158379|NCT01715532|Drug|Huachansu|
16158380|NCT01715532|Other|TACE|
16158381|NCT01715519|Drug|Treatment (Viibryd)|
16158426|NCT01715194|Device|Telemedicine intervention|Patients undergoing telemedicine intervention
16158382|NCT01715506|Behavioral|Educational intervention|The educational intervention (EI), Relation Related Care (RRC), consists of a two-day seminar and one hour monthly guidance for six months. Course material, a book particularly designed for this intervention and dealing with person centered care and use of restraint, is distributed ahead of the course part of the intervention to all participants.
16158383|NCT01715493|Drug|lysozyme 90 mg|Lysozyme 90 mg three times daily for 4 weeks followed by placebo for 4 weeks (plus usual COPD medication)
16158384|NCT01715493|Drug|Placebo|Lysozyme Matching Placebo three times daily for 4 weeks followed by Lysozyme 90 mg three times daily for 4 weeks (plus usual COPD medication)
16158385|NCT01715480|Dietary Supplement|Broccosprouts® (Brassica Protection Products LLC) homogenate|"In the in-vitro part of the study, sulphoraphane will be added into the culture media used to grow and differentiate the erythroid cells from blood samples obtained from three Hb AA volunteers and three Hb SS subjects. The subjects will have a single clinic visit for the blood donation.
~In the second part of the study, enrolled subjects will be asked to consume homogenates of broccoli sprouts by mouth daily for three weeks. They will have a maximum of five clinic visits for medical assessments and lab draws during this time. They will then have a final clinic visit after a washout period of six weeks."
16158386|NCT01715441|Drug|Sorafenib and irinotecan combination|
16158387|NCT01715441|Drug|Sorafenib monotherapy|
16158388|NCT01715441|Drug|Irinotecan monotherapy|
16158389|NCT01715415|Drug|ABT-450/r/ABT-267, ABT-333|Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
16158390|NCT01715415|Drug|Ribavirin|Capsule (double-blind treatment period), tablet (open-label treatment period)
16158391|NCT01715415|Drug|Placebo for ABT-450/r/ABT-267|Tablet
16158392|NCT01715415|Drug|Placebo for ABT-333|Tablet
16158393|NCT01715415|Drug|Placebo for ribavirin|Capsule
16158394|NCT01715402|Procedure|liver surgery|this intervention type includes hepatectomies; wedge; segmentectomies etc...
16158395|NCT01715389|Other|MyAsthma Patient Portal|"Parents in the intervention group will use the MyAsthma Patient Portal to receive enhanced educational information on asthma and its treatment, identify concerns and goals related to asthma treatment, track progress toward goals and management of concerns monthly, and track asthma symptoms monthly.
~Clinicians seeing intervention families at office visits will have access to information from the portal including concerns, goals, progress toward goals, and tracking of asthma symptoms."
16158396|NCT01715363|Drug|Oxaliplatin|
16158397|NCT01715363|Drug|Folinic Acid|
16158398|NCT01715363|Drug|Fluorouracile|
16158399|NCT01715350|Drug|PM012|"The drug will be taken with water within 30 minutes after breakfast and supper.
~650mg/1 tablet, PO, 12weeks"
16158400|NCT01715350|Drug|Placebo|"The drug will be taken with water within 30 minutes after breakfast and supper.
~650mg/1 tablet, PO, 12weeks"
16158401|NCT01715337|Other|pulmonary rehabilitation|3-week rehabilitation including exercise training, breathing therapy, psychosocial support, medical treatment etc.
16158402|NCT01715324|Drug|Adjuvant Growth Hormon|The treatment group will receive 2.5 mg of Saizen daily via subcutaneous injections, from the beginning of the ovarian reserve stimulation until the day of the ovulation triggering
16158403|NCT01715311|Drug|Indacaterol|Indacaterol once daily via single-dose dry powder inhaler
16158404|NCT01715311|Drug|Placebo to tiotropium|Placebo to tiotropium capsules for inhalation once daily
16158405|NCT01715311|Drug|Tiotropium|Tiotropium capsules for inhalation once daily
16158406|NCT01715311|Drug|Placebo to indacaterol|Placebo to indacaterol capsules for inhalation once daily
16158407|NCT01715298|Drug|NVA237|NVA237 (Glycopyrronioum bromide) as a powder for inhalation in single-dose capsules
16158408|NCT01715298|Drug|Placebo|Placebo powder for inhalation in single-dose capsules (matching those for NVA237).
16158409|NCT01715285|Drug|Abiraterone acetate|Abiraterone acetate tablets will be administered orally at a total dose of 1000 mg per day until disease progression, withdrawal of consent or unacceptable toxicity.
16158410|NCT01715285|Drug|Prednisone|Prednisone 5 mg capsule will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
16158411|NCT01715285|Other|Androgen deprivation therapy (ADT)|All participants will receive stable regimen of ADT, that is, lutenizing hormone releasing hormone (LHRH) agonists or surgical castration according to local guidelines until disease progression, withdrawal of consent or unacceptable toxicity.
16158412|NCT01715285|Drug|Abiraterone acetate Placebo|Placebo matched to abiraterone acetate will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
16158413|NCT01715285|Drug|Prednisone Placebo|Placebo matched to prednisone will be administered orally once daily until disease progression, withdrawal of consent or unacceptable toxicity.
16158414|NCT01715272|Device|TF037|
16158415|NCT01715272|Drug|Fleet enema|
16158416|NCT01715259|Drug|Abiraterone acetate: participants with end-stage renal disease|abiraterone acetate 1000 mg (4 x 250 mg tablets) taken by mouth as a single dose in the fasted state on Day 1
16158417|NCT01715259|Drug|Abiraterone acetate: matched control participants with normal renal function|abiraterone acetate 1000 mg (4 x 250 mg tablets) taken by mouth as a single dose in the fasted state on Day 1
16158418|NCT01715246|Other|Infant Formula|
16158419|NCT01715233|Drug|Docetaxel|Modified Docetaxel 40mg/m2 on Day 1
16158420|NCT01715233|Drug|Leucovorin|Leucovorin 400mg/m2 on Day 1
16158421|NCT01715233|Drug|Fluorouracil|Fluorouracil 400mg/m2 on Day 1 Fluorouracil 1000mg/m2/day on Days 1 and 2
16158422|NCT01715233|Drug|Cisplatin|Cisplatin (or Carboplatin) 40mg/m2 on Day 3
16158423|NCT01715220|Drug|sublingual nitroglycerine|A convenience sample of patients presenting to the Emergency Department will be randomized to receive either sublingual 0.4 mg doses of nitroglycerin or placebo. Pain prior to and at two minutes and five minutes after medication administration will be assessed using a visual analog scale. The medication will be either a 0.4 mg dose of nitroglycerin or a placebo. If pain is not completely relieved within five minutes, a second dose will be administered after blood pressure assessment. If the pain is not completely relieved after an additional two minute and five minute assessment or the pain returns, it will be treated in the standard manner at the discretion of the treating Emergency Physician
16158424|NCT01715207|Drug|Aliskiren|
16158425|NCT01715207|Drug|Atenolol|
16170024|NCT01624285|Other|placebo|Given PO
16158427|NCT01715181|Other|Volunteer visits|Volunteers will visit 3 times per week with a visit duration of 30 minutes for each visit during the study.
16158428|NCT01715168|Drug|DOXIL/CAELYX|
16158429|NCT01715168|Drug|ATI-0918|
16158430|NCT01715142|Drug|Gemcitabine|Administrated intravenously at a dose of 1000 mg/m2 over 30 minutes weekly, on day 1, day 8, day 15 followed by one week of rest (before surgery of before starting of the next cycle depending on the cohort allocation)
16158431|NCT01715142|Drug|Abraxane|Administrated intravenously at a dose of 125 mg/m2 over 30 minutes weekly, on day 1, day 8, day 15 followed by one week of rest (before surgery of before starting of the next cycle depending on the cohort allocation)
16158432|NCT01715129|Drug|Triptorelin Pamoate 11.25mg|
16158433|NCT01715116|Device|Enhanced ICD programming|"VT monitor: > 166/min
~fVT: > 182/min; via VF 60/80 intervals (number of intervals to start ATP after approximately 20 s); 3 x ATP (8 stimuli, 88%, scan 20 ms); shock 1-5: 35 J; redetection 30/40 intervals.
~VF: > 250/min; via VF 60/80 intervals (number of intervals to start therapy after approximately 15 s); 1 x ATP (8 stimuli, 88%) during charging; all shocks: 35 J; redetection 30/40 intervals
~SVT/VT discrimination is turned on, high rate time out is OFF
~SVT/VT discrimination single chamber: stability, wavelet; SVT upper rate limit: 222/min
~SVT/VT discrimination dual/triple chamber: P/R logic, wavelet; SVT upper rate limit: 222/min
~T wave-oversensing and lead noise discrimination is turned on in all devices."
16158434|NCT01715103|Procedure|vaginal swabs by washing and cytobrush|vaginal swabs by washing and cytobrush
16158435|NCT01715090|Device|Web-based insulin titration|
16158436|NCT01715077|Drug|Ipilimumab at 3 mg/kg dose|
16158437|NCT01715064|Behavioral|Exercise|1 hour of moderate-intensity exercise
16158438|NCT01715051|Drug|D-serine|The molecular formula for D-serine is C3H7NO3. D-serine is being used in IND# 71,369 (D Javitt, PI) and in IND#76,940 (H Singer, PI). This approved D-serine will be purchased by the Research Pharmacy at Johns Hopkins and will be encapsulated into capsules containing 500 mg of D-serine.
16158439|NCT01715051|Behavioral|Cognitive Behavioral Therapy|CBT sessions will be offered weekly to both active medication and placebo arms. The National Institute on Drug Abuse (NIDA) published CBT treatment manual for cocaine dependence, written by Kathleen Carroll, Ph.D., will be utilized. The skills taught in this CBT manual include (1) self-monitoring and functional analysis of situational factors associated with craving or drug use; (2) learning alternative non-drug responses for handling high risk situations; and (3) general lifestyle modifications (e.g., increasing pleasant drug-free events, anger management, interpersonal skills, general problem-solving).
16158440|NCT01715051|Drug|Placebo|The Research Pharmacy at Johns Hopkins will produce matching placebo capsules.
16158441|NCT01715038|Dietary Supplement|LNS-PLW|"Dietary supplement: Lipid-based nutrient supplement
~Lipid-based nutrient supplement for pregnant and lactating women (LNS-PLW)
~Daily dose of LNS-PLW will be 20 g, packaged in one sachet"
16158442|NCT01715038|Dietary Supplement|LNS-Child|"Dietary supplement: Lipid-based nutrient supplement
~Lipid-based nutrient supplement for infants and young children (LNS-Child)
~Daily dose of LNS-Child will be 20 g, packaged in two 10 g sachets"
16158443|NCT01715038|Dietary Supplement|MNP|"Dietary supplement: Micronutrient powder
~Micronutrient powder for infants and young children (MNP)
~The MNP for children will be packaged in 1 g sachets, so that each day, the child will consume one sachet."
16158444|NCT01715038|Dietary Supplement|IFA|"Dietary supplement: Iron and folic acid nutrient supplement
~Iron-folic acid tablets for pregnant and lactating women
~Daily dose of iron-folic acid supplement will be one tablet containing 60 mg iron and 400 mcg folic acid"
16158445|NCT01715025|Drug|E2Nomac|Women will start the first cycle of the COC on the first day of their period in the treatment phase of the study
16158446|NCT01715012|Biological|ST266|ST266 is applied daily by spray to burn wound and skin graft donor site
16158447|NCT01715012|Drug|Saline|Saline is applied daily by spray to burn wound and skin graft donor site
16158448|NCT01714999|Procedure|Bursectomy|Bursectomy of the OB and PB are performed in the operation theatre under sterile conditions. In case of a laceration of the OB a leash, in case of PB a redon drainage (Charr. 10) is inserted. After application of a sterile bandage a cast is applied in both cases. Patient will receive AB for 5 days, the affected limb will be immobilized until removal of the stiches after 12-14 days.
16158449|NCT01714999|Procedure|Bursal reconstruction|The bursal laceration is treated within in ER setting. The wound is cleaned and thoroughly washed, if needed the wound margins are excised. The wound is then closed using simple suture and a plaster applied and removed 5 days later. Antibiotics are be administered for 5 days
16158450|NCT01714986|Behavioral|Affect School|
16158451|NCT01714986|Behavioral|Body Awareness Therapy|
16158452|NCT01714973|Biological|ST266|Patients will receive ST266 spray, to half the breast and saline to the other half (blinded) after each of ten consecutive radiation therapy treatments. ST266 and saline will be sprayed onto the breast to deliver 0.01 ml/cm2.
16158453|NCT01714960|Drug|MRZ-99030 eye drops 5mg/mL|
16158454|NCT01714960|Drug|MRZ-99030 eye drops 20mg/mL|
16158455|NCT01714960|Drug|Placebo to MRZ-99030 eye drops|
16158456|NCT01714947|Drug|[^14C]-alisertib|[^14C]-alisertib oral solution
16158457|NCT01714947|Drug|alisertib|Alisertib enteric coated tablets
16158458|NCT01714908|Other|Erlotinib w Concurrent Radiotherapy|
16158459|NCT01714908|Other|etoposide/cis-platin (EP) w Concurrent Radiotherapy|Etoposide / Cis-platin w Concurrent Radiotherapy
16158460|NCT01714895|Other|High insulin eu-hypoglycemic clamp|Primed intravenous insulin infusion at a rate of 1mU/kg/min is given during the whole study duration. Glucose is infused at a variable rate to maintain plasma glucose concentrations 'clamped' at pre-specified levels. Plasma glucose levels will be the same in both study arms.
16158461|NCT01714895|Other|Low insulin eu-hypoglycemic clamp|Primed intravenous insulin infusion at a rate of 0.3mU/kg/min is given during the whole study duration. Glucose is infused at a variable rate to maintain plasma glucose concentrations 'clamped' at pre-specified levels. Plasma glucose levels will be the same in both study arms.
16158462|NCT01714882|Behavioral|Stress Management & Resiliency Training|The couples in this group will attend the SMART in-person training class at the beginning of the study and will be taught a structured relaxation program.
16158463|NCT01714882|Behavioral|Stress Management DVD|The couples in this group will receive a Mayo Clinic Stress Management DVD.
16159044|NCT01710514|Drug|FE 999913 vaginal tablet|
16158464|NCT01714869|Other|Swedish Massage|Swedish Massage, once per week for 8 weeks, 60 minutes per session.
16158465|NCT01714856|Drug|Ropinirole hydrochloride CR 2mg Tablets|Ropinirole is an orally administered non-ergoline dopamine agonist. Ropinirole is indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease.
16158466|NCT01714843|Drug|linaclotide|oral
16158467|NCT01714843|Drug|placebo|oral
16158468|NCT01714830|Device|standars electromagnetic DUOLITH SD1|In the first group patients will be treated by ESWT once a week for 4 weeks. (Each time 3000 impulses, with 0.25 mJouls/M2 and 3 Hertz of frequency. After each 500 pulses, the probe position will be corrected, using trans-perineal ultrasound.
16158469|NCT01714830|Device|turn off standars electromagnetic DUOLITH SD1|In the control group, the same protocol is applied but with the probe being turned off.
16158470|NCT01714817|Biological|BMS-188667|
16158471|NCT01714817|Drug|Mycophenolate mofetil|
16158472|NCT01714817|Drug|Prednisone|
16158473|NCT01714817|Biological|Placebo matching with BMS-188667|
16158474|NCT01714804|Device|Accell Evo3 Prospective Use|
16158475|NCT01714791|Other|Usual care|Patients exercise at a heart rate corresponding to 65% of baseline Vo2peak. Each exercise training session takes 40-60 minutes. Exercise time is apportioned as follows: 42% on the treadmill, 33% on the circle ergometer and 25% on the arm cranking device. All patients exercise under close supervision 3 days per week for a total duration of 12 weeks.
16158476|NCT01714791|Other|Osteopathic treatment|"Patients receive 4 osteopathic treatments (OT). OT is performed in week 4, 5, 8 and 12 postoperative. Depending on what is found in the patient, treatments consist mostly of one or more of the following approaches:
~Structural High Velocity Low Amplitude-techniques.
~Muscle Energy Techniques.
~General osteopathic mobilisations.
~Functional techniques (Sutherland-, Jones-techniques,…) including inhibition techniques.
~Fascia techniques.
~Soft tissue- and connective tissue techniques.
~Neurovisceral and neurolymphatic reflex techniques.
~Fluidal techniques (lymphatic manipulative techniques,...).
~Visceral manipulations.
~Neurocranial and viscerocranial techniques."
16158477|NCT01714778|Other|e-Cigarette|
16158478|NCT01714765|Drug|Dovitinib|Cohort 0: 200mg, Cohort 1: 300mg, Cohort 2: 300mg, Cohort 3: 400mg, Cohort 4: 500mg. Cohort -1: 100mg
16158479|NCT01714765|Drug|Everolimus|Cohort 0: 5mg, Cohort 1: 5mg, Cohort 2: 10mg, Cohort 3: 10mg, Cohort 4: 10mg, Cohort -1: 5mg.
16158480|NCT01714752|Procedure|measure of left ventricular and diastolic pressure at exercise|
16158481|NCT01714739|Drug|Lirilumab|Specified dose on specified days.
16158482|NCT01714739|Drug|Nivolumab|Specified dose on specified days.
16158483|NCT01714739|Drug|Ipilimumab|Specified dose on specified days.
16158484|NCT01714726|Drug|MEDI2070|1 iv infusion on Week 0 and Week 4
16158485|NCT01714726|Drug|placebo|1 iv infusion on Week 0 and Week 4
16158486|NCT01714713|Drug|EVP-6124|Arm 1, 2
16158487|NCT01714700|Behavioral|High protein diet, Resistance exercise|The progressive supervised resistance exercise training program was performed by all participants under supervision. They participated in an onsite supervised protocol for 12 weeks (six days per week); weeks 1-4 (Monday - pectorialis major, Tuesday - latissimus dorsi, Wednesday - femoral, Thursday - deltoid, Friday - biceps brachii, Saturday - triceps brachii muscle), weeks 5-8 (Monday and Friday- pectorialis major and triceps brachii, Tuesday and Saturday - latissimus dorsi and biceps brachii, Wednesday and Monday - femoral, Thursday and Tuesday - deltoid muscle), weeks 9-12 (Monday and Thursday - pectorialis major and latissimus dorsi, Tuesday and Friday - femoral and deltoid, Wednesday and Saturday - triceps brachii and biceps brachii muscle).
16158488|NCT01714700|Behavioral|Standard diet, Resistance exercise|The progressive supervised resistance exercise training program was performed by all participants under supervision. They participated in an onsite supervised protocol for 12 weeks (six days per week); weeks 1-4 (Monday - pectorialis major, Tuesday - latissimus dorsi, Wednesday - femoral, Thursday - deltoid, Friday - biceps brachii, Saturday - triceps brachii muscle), weeks 5-8 (Monday and Friday- pectorialis major and triceps brachii, Tuesday and Saturday - latissimus dorsi and biceps brachii, Wednesday and Monday - femoral, Thursday and Tuesday - deltoid muscle), weeks 9-12 (Monday and Thursday - pectorialis major and latissimus dorsi, Tuesday and Friday - femoral and deltoid, Wednesday and Saturday - triceps brachii and biceps brachii muscle)
16158489|NCT01714687|Device|balloon sinus dilation|
16158490|NCT01714687|Other|medical therapy|
16158491|NCT01714674|Dietary Supplement|Dietary nitrate beverage|ingestion of single dose NaNO3 beverage two hours prior to exercise bout
16158492|NCT01714674|Dietary Supplement|NaCl beverage|ingestion of single dose NaCl beverage two hours prior to exercise bout
16158493|NCT01714661|Drug|EVP-6124|Arms 1, 2
16158494|NCT01714661|Drug|Placebo|Arm 3
16158495|NCT01714648|Drug|Triptorelin 0.2 mg|A single bolus of 0.2 mg triptorelin given 34-36 hours before oocyte retrieval.
16158496|NCT01714635|Device|Tecnis Multifocal Intraocular Lens|
16158497|NCT01714635|Device|Monofocal Intraocular Lens|
16158498|NCT01714622|Procedure|subtotal gastrectomy with gastroduodenostomy|
16158499|NCT01714622|Procedure|subtotal gastrectomy with Roux-en-Y gastrojejunostomy,|
16158500|NCT01714622|Procedure|total gastrectomy with Rou-en-Y esophagojejunostomy|
16158501|NCT01714609|Drug|Placebo|Placebo Comparator: Placebo
16158502|NCT01714609|Drug|Sorafenib|Sorafenib, 400 mg twice daily
16158503|NCT01714596|Other|PO versus IV antibiotics Route of administration evaluation|This is a study of oral (per os, (PO)) antibiotic therapy versus intravenous (IV) antibiotics in the treatment of acute infection after fixation of fractures and joint fusions. This is not a study of an experimental drug but a study of route of administration of standard use antibiotics. Antibiotic regimen options decision will be made by the Study Surgeon at each site in consult with local Infectious Disease experts based on local standard practices and bacterial susceptibilities.
16158504|NCT01714570|Drug|Piperacillin-tazobactam combination product|4.5g q6h, 5-10 days
16158505|NCT01714570|Drug|Imipenem|0.5g q6h, 5-10 days
16158506|NCT01714557|Drug|Piperacillin|4.0g q8h 3-5 days
16158507|NCT01714557|Drug|Piperacillin-tazobactam combination product|4.5g q8h 3-5 days
16158508|NCT01714544|Drug|Cloderm Cream|
16158509|NCT01714531|Behavioral|Telephone-Based Goal Management Training|
16158510|NCT01714531|Behavioral|Telephone-Based Attention-Control|
16158511|NCT01714505|Device|Diabetes Assistant (DiAs)|A medical platform that uses a smart-phone to connect to a continuous glucose sensor to insulin pump and run closed-loop control. The cell phone runs the Control to Range and is connected to work with the insulin pump and continuous glucose monitor to help keep the blood sugar in a desired range (80-180 mg/dL during the day) and help avoid hypoglycemia during the night.
16158512|NCT01714492|Device|Sigma Posterior Stabilizing Rotating Platform TKA Beaded Poly|Sigma PS RP TKA including a polyethylene insert with 4 beads
16158513|NCT01714479|Other|Leucine-enriched nutritional supplement|A protein and carbohydrate supplement with high levels of leucine
16158514|NCT01714479|Other|Placebo|
16158515|NCT01714466|Drug|NER1006|
16158516|NCT01714466|Drug|MOVIPREP|
16158517|NCT01714427|Drug|Dexamethasone|Two doses of 40mg dexamethasone (in 100 ml physiologic saline solution, respectively) will be administered intravenously prior to LPS instillation.
16158518|NCT01714427|Drug|Sterile isotonic saline|two doses of 100 ml physiologic saline solution will be administered intravenously prior to LPS instillation.
16158519|NCT01714414|Drug|FZD|
16158520|NCT01714414|Drug|3TC|
16158521|NCT01714414|Drug|EFV|
16158522|NCT01714414|Drug|AZT|
16158523|NCT01714401|Drug|Salbutamol 2,5 mg|20 min nebulization of 2.5 mg of salbutamol
16158524|NCT01714401|Drug|Salbutamol 5mg|20 min nebulization of 5 mg of salbutamol
16158525|NCT01714388|Drug|Remifentanil|1mcg/kg iv dose, followed by 5 minutes ECG recording
16158526|NCT01714375|Device|QuietDose Device|"The intervention will test the effectiveness of a noise exposure dosimeter, the QuietDose - that measures a worker's daily noise dose, as well as peak noise exposure, inside of the worker's hearing protectors. Workers and the study coordinator receive daily feedback about noise exposures (if the device was used outside of the study it would be safety personnel that received the feedback outside of the workers themselves). Such feedback will allow steps to be taken to minimize such exposures, such as behavioral adjustments and improved awarenessThe goal of this study is to determine whether daily assessment and feedback of workers' noise exposures leads to more effective use of hearing protection and prevention of noise-induced hearing loss."
16158527|NCT01714349|Procedure|Nerve Transfer|A nerve transfer procedure will be individualized to each patient's functional deficit.
16158528|NCT01714336|Drug|tranexamic acid|Tranexamic acid will be administered intravenously in two doses of 15 mg/kg. Each dose will be administered over a period of ten minutes, one dose just prior to incision and the second at initiation of wound closure.
16158529|NCT01714336|Drug|placebo|A similar dose of 0.9% sodium chloride (NaCL) will be administered intravenously in two doses over a ten minute period, one dose at incision and the other at initiation of wound closure.
16158530|NCT01714323|Behavioral|Sustained Care|A 3-month program after hospital discharge with these 2 components: (1) Free Medication - A 30-day supply of FDA-approved medication (nicotine replacement, bupropion, or varenicline) given at hospital discharge and refillable for a total of 90 days to encourage medication use and adherence; (2) Interactive Voice Response (IVR) Triage to Telephone Counseling from a national quitline provider (Alere Wellbeing, Inc., previously Free & Clear). IVR aims to encourage medication adherence and enhance counseling efficiency by identifying smokers who need post-discharge support. Immediate transfer of a patient from automated IVR call to live telephone counselor will facilitate a successful connection to counseling.
16158531|NCT01714323|Behavioral|Standard Care|Standard care consists of a handout with information about how to contact the state telephone quitline for additional smoking cessation support and to use smoking cessation medication as recommended by the hospital smoking counselor.
16158532|NCT01714310|Drug|lisdexamfetamine|Titration and open label treatment from baseline visit for 12 week study.
16158533|NCT01714310|Drug|Placebo|Initiated at end of study week 4 and continued to study week 12.
16158534|NCT01714310|Drug|fluoxetine|Initiated at end of study week 4 and continued to study week 12.
16158535|NCT01714297|Drug|dalteparin 5000 IU s.c.|All patients receive injections with either 5000IU dalteparin or saline in the same volume the evening before surgery. All patients receive 5000IU dalteparin 6 hours after surgery and every day from day 2 until day 35.
16158536|NCT01714284|Behavioral|Informative|The intervention consists in a simple informative counseling about the utility of weight loss for clinical control of psoriatic disease.
16158537|NCT01714284|Behavioral|Diet and Exercise|The intervention consists in a 20 weeks quantitative and qualitative dietary plan for weight loss associated with physical exercise. The plan will be developed with the help of qualified staff (Dieticians) and elaborated in relation to individual needs of the patient.
16158538|NCT01714271|Behavioral|Home environs-based lifestyle counseling|Social learning theory-based behavior modification embedded in a social ecological framework is used to shape both the home environment and the lifestyle choices of the study participants to optimize their adherence to the Dietary Guidelines for Americans and the Physical Activity Guidelines for Americans.
16158539|NCT01714271|Behavioral|Cancer early detection|Conventional health education is used to increase study participant knowledge of practical strategies for detecting and treating common cancers early, before cancers have metastasized. Additional instruction is devoted to the biology and physiology of the cancer process. Although some mention will be made of the importance of maintaining a healthy weight for minimizing lifetime risk of certain cancers, most of the focus will be on episodic cancer screening, e.g., mammograms, PAP smears, colonoscopies, etc. for prevention of death from cancer.
16158540|NCT01714258|Procedure|cardiac output measurement|non invasive cardiac output estimation based on passive induced prolonged expiration in mechanically ventilated patients
16158541|NCT01714232|Device|Contour® PLUS BGMS|Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
16158542|NCT01714232|Device|OneTouch® SelectSimple™ BGMS|Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
16158584|NCT01713959|Device|Ulthera System treatment|Ulthera System: Focused ultrasound energy delivered below the surface of the skin.
16158543|NCT01714232|Device|Accu-Chek® Performa BGMS|Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
16158544|NCT01714232|Device|Accu-Chek® Active BGMS|Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
16158545|NCT01714232|Device|Freestyle Freedom® BGMS|Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
16158546|NCT01714219|Procedure|Posterior reconstruction|
16158547|NCT01714206|Drug|Digoxin 0.5 mg|Two 0.25 mg tablets (0.5 mg total dose) taken orally (by mouth) on Day 1.
16158548|NCT01714206|Drug|Digoxin 0.25 mg|One 0.25 mg tablet taken orally on Days 2 through 7.
16158549|NCT01714206|Drug|Canagliflozin (JNJ-28431754)|One 300 mg tablet taken orally on Days 1 through 7.
16158550|NCT01714193|Drug|Oral contraceptive|One tablet (0.150 mg of levonorgestrel and 0.030 mg of ethinyl estradiol) taken orally (by mouth) on Day 1 and Day 9.
16158551|NCT01714193|Drug|Canagliflozin (JNJ-28431754)|One 200 mg tablet taken orally (by mouth) on Days 4 through 9.
16158552|NCT01714167|Genetic|intracerebral stem cell transplantation|Intracerebral transplantation of autologous bone marrow mesenchymal stem cell, 2-4 million stem cells per patient
16158553|NCT01714154|Drug|danoprevir|100 mg orally every 12 hours
16158554|NCT01714154|Drug|ritonavir|100 mg orally every 12 hours
16158555|NCT01714154|Drug|setrobuvir|200 mg orally every 12 hours
16158556|NCT01714141|Behavioral|Multi-component, technology based intervention|Motivational sessions were adapted from work done with young adults with HIV (MESA).
16158557|NCT01714141|Behavioral|Asthma education active control|
16158559|NCT01714115|Drug|Aflibercept|2.0 mg Intravitreal Injection, every 2 to 4 weeks
16158560|NCT01714102|Dietary Supplement|Placebo|Placebo manufactured to mimic resveratrol tablet
16158561|NCT01714102|Dietary Supplement|Resveratrol|Resveratrol PO BID for 30 days
16158562|NCT01714089|Drug|RNS60 125 ml|
16158563|NCT01714089|Drug|RNS60 250 ml|
16158564|NCT01714089|Drug|Interferon beta 1a|
16158565|NCT01714076|Other|cohort isolation|all patients hospitalised for bronchiolitis are nursed in one room together, separated from patients without bronchiolitis
16158566|NCT01714063|Device|Pressurized Metered-Dose Inhaler|Pressurized Metered-Dose Inhaler
16158567|NCT01714050|Behavioral|Cognitive-Behavioral Therapy (CBT)|
16158568|NCT01714050|Device|Light Therapy (LT)|SunRay (SunBox Company, Gaithersburg, MD)
16158569|NCT01714037|Drug|Debio 0932|Debio 0932 will be administered as daily oral tablets at a starting dose of 250 mg four times per day (QD).
16158570|NCT01714037|Drug|Cisplatin|Cisplatin 75 mg/m2 body surface area (BSA) will be administered on Day 1 of each 21-day treatment cycle.
16158571|NCT01714037|Drug|Pemetrexed|Pemetrexed 500 mg/m2 BSA will be administered on Day 1 of each 21 day treatment cycle.
16158572|NCT01714037|Drug|Gemcitabine|Gemcitabine 1250 mg/m2 BSA will be administered on Days 1 and 8 of each 21-day treatment cycle.
16158573|NCT01714037|Drug|Docetaxel|Docetaxel 60 or 75 mg/m2 BSA will be administered on Day 1 of each 21-day treatment cycle.
16158574|NCT01714024|Device|Zimmer Trabecular Metal Test Cylinder|For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
16158575|NCT01714024|Device|Zimmer Titanium Test Cylinder|For all subjects 2 titanium and 2 trabecular 2.9-3.0 mm x 5 mm test cylinders will be implanted in alveolar bone. One of each type will be removed at 2 weeks. The remaining two will be removed at 4 weeks.
16158576|NCT01714011|Drug|Ziprasidone|"Ziprasidone's activity is primarily due to the parent drug. The multiple-dose pharmacokinetics of ziprasidone are dose-proportional within the proposed clinical dose range, and ziprasidone accumulation is predictable with multiple dosing. Elimination of ziprasidone is mainly via hepatic metabolism with a mean terminal half-life of about 7 hours within the proposed clinical dose range.
~Steady-state concentrations are achieved within one to three days of dosing. The mean apparent systemic clearance is 7.5 mL/min/kg. Ziprasidone is unlikely to interfere with the metabolism of drugs metabolized by cytochrome P450 enzymes. Ziprasidone is well absorbed after oral administration, reaching peak plasma concentrations in 6 to 8 hours."
16158577|NCT01714011|Drug|Aripiprazole|Aripiprazole activity is presumably primarily due to the parent drug, aripiprazole and to a lesser extent, to its major metabolite, dehyrdro-aripiprazole. Steady state concentrations are attained with in 14 days of dosing. The mean elimination half lives are about 75 hours and 95 hours respectively. Elimination of aripiprazole is mainly through hepatic metabolism involving two P450 isozymes, CYP2D6 and CYP3A4. Aripiprazole is well absorbed, with peak plasma concentrations occurring within 3-5 hours; the absolute oral bioavailability of the tablet formulation is 87%. Absorption of aripiprazole is not affected by food.
16158578|NCT01713998|Device|Ulthera System Treatment|Focused ultrasound energy delivered below the surface of the skin
16158579|NCT01713985|Device|Ulthera System Treatment|Focused ultrasound energy delivered below the surface of the skin
16158580|NCT01713985|Device|Thermage|Radiofrequency treatment focusing radiofrequency energy
16158581|NCT01713972|Drug|dabrafenib|Given PO
16158582|NCT01713972|Drug|pazopanib hydrochloride|Given PO
16158583|NCT01713972|Other|Correlative studies|"Pharmacokinetic studies:
~Blood draw for various time points:
~Cycle 1 Days 1, 2, 3, 4 and 15; Cycle 2 Days 1, 2; and day 1 of Cycles 4, 6 and 12
~Pharmacogenomic studies: Blood draw on Cycle 1 Day 1
~Tumor genotyping: Archival tumor blocks or unstained slides
~BRAF mutation quantification in circulating plasma DNA: Blood draw on Cycles 1-7 Day 1 and every other cycle thereafter; and at time of progression"
16158756|NCT01712568|Drug|Reference Product (REQUIP )|"one Tablet at 0 hour"
16158585|NCT01713959|Device|Sham treatment|Sham Treatment: Use of the Ulthera System with the system adjusted to deliver 0 energy.
16158586|NCT01713946|Drug|RAD001|Everolimus tablets for oral suspension (dispersible tablets) were packaged as 2 mg tablets in blister packs and placed in boxes with color-coded labels, color 1 or color 2.
16158587|NCT01713946|Drug|Placebo|Placebo tablets for oral suspension (dispersible tablets) were packaged as 2 mg tablets in blister packs and placed in boxes with color-coded labels, color 1 or color 2.
16158588|NCT01713946|Drug|Antiepileptic drug (1 to 3 only)|no more than any 3 of the listed antiepileptic drugs could be taken with the study drug or placebo. List of allowed antiepileptic drugs were: valporic acid, carbamazepine, clobazam, N-desmethylclobazam, topiramate,TRI477, TRI476, clonazepam, zonisamide, phenobarbital, phenytoin
16158589|NCT01713946|Drug|open label RAD001 (only used for post-extension phase)|everolimus tablets for oral suspension (dispersible tablets) were packaged as 2 mg tablets in blister backs in boxes with open label design and were taken during the Post-Extension phase, where all the participants, including those who were previously on placebo, took the 2mg tablets.
16158590|NCT01713933|Device|Ulthera® System|Focused ultrasound energy delivered below the surface of the skin.
16158591|NCT01713920|Drug|SEVIKAR|
16158592|NCT01713907|Device|Ulthera® Treatment|Focused ultrasound energy delivered below the surface of the skin.
16158593|NCT01713894|Other|Decision Aid|
16158594|NCT01713894|Other|Standard|
16158595|NCT01713868|Behavioral|Safe Sleep Nursery Education|Nursery-based program for safe sleep
16158596|NCT01713868|Behavioral|Breastfeeding Nursery Education|Nursery-based program to promote breastfeeding
16158597|NCT01713868|Behavioral|Breastfeeding Mobile Health Messaging|Mobile messaging to provide multiple short culturally competent videos to promote breastfeeding delivered via email.
16158598|NCT01713868|Behavioral|Safe Sleep Mobile Health Messaging|Mobile messaging to provide multiple short culturally competent videos to promote safe sleep practices delivered via email.
16158599|NCT01713855|Biological|Inactivated Trivalent Influenza vaccine|
16158600|NCT01713842|Drug|TCZ|Tocilizumab at week 0, 4 and 8.
16158601|NCT01713829|Other|Cranberry Beverage|8 oz cranberry beverage consumed daily for 12 weeks
16158602|NCT01713829|Other|Placebo Beverage|8 oz placebo beverage consumed daily for 12 weeks
16158603|NCT01713803|Drug|Buprenorphine and naloxone|
16158604|NCT01713790|Device|Stochastic resonance whole-body vibration|Stochastic resonance whole-body vibration training program over 10 weeks, three times a week with 3 to 6 Hz, Noise 4.
16158605|NCT01713790|Device|Exergame|training program over 10 weeks, three times a week.
16158606|NCT01713790|Device|Leg press|training program over 10 weeks, three times a week.
16158607|NCT01713777|Drug|"Lamotrigine Generic A"|
16158608|NCT01713777|Drug|"Lamotrigine generic B"|
16158609|NCT01713764|Behavioral|Low Carbohydrate Diet|
16158610|NCT01713764|Behavioral|American Diabetes Association Diet|
16158611|NCT01713764|Behavioral|Mindfulness and Positive Affect Skills|
16158612|NCT01713751|Other|Interrupted suturing|Skin is closed with interrupted mattress stitches using non-absorbable polypropylene [Prolene®]
16158613|NCT01713751|Other|Subcuticular suturing|Skin is closed with subcuticular stitches using non-absorbable polypropylene [Prolene®]
16158614|NCT01713738|Drug|rituximab|infusion of 4 weekly doses of 375 mg/m2 rituximab
16158615|NCT01713725|Biological|Omalizumab|"Two injections will be administered the first two weeks
~The following three injections will be administered every four weeks Consequently, we will administer 5 doses within 14 weeks"
16158616|NCT01713725|Biological|Placebo|"Two injections will be administered the first two weeks
~The following three injections will be administered every four weeks Consequently, we will administer 5 doses within 14 weeks"
16158617|NCT01713712|Behavioral|Nutritional Counseling|Patients will keep a daily diary of nutritional intake as well as physical activity. They will also follow up with the nutritional counselor six weeks postpartum.
16158618|NCT01713699|Procedure|lumbar puncture|
16158619|NCT01713686|Device|Ulthera System Treatment|Focused ultrasound energy delivered below the surface of the skin
16158620|NCT01713673|Drug|Ulthera System Treatment|Focused ultrasound energy delivered below the surface of the skin
16158621|NCT01713673|Drug|Sham treatment|Study treatment using the Ulthera System, but delivering no ultrasound energy.
16158622|NCT01713660|Device|iFS Femtosecond Laser|corneal incisions created by the femtosecond laser
16158623|NCT01713647|Drug|Amlodipin, losartan, HCTZ|
16158624|NCT01713634|Other|Preflight|4-d controlled diet sessions will occur twice before flight.
16158625|NCT01713634|Other|In-flight|4-d controlled diet sessions will take place on flight days 15, 60, 120, and 180. Flight day 30 will only be monitored intakes (subject consume nominal intake)
16158626|NCT01713621|Drug|OZ439|OZ439 is a novel synthetic trioxolane antimalarial agent
16158627|NCT01713608|Drug|OZ439|OZ439 x mg once daily for 3 days with milk
16158628|NCT01713595|Drug|Hypertonic Saline Aerosol|A single 5ml dose of 7% Saline aerosol
16158629|NCT01713582|Drug|OTX015/Birabresib|OTX015/Birabresib 10 mg, 20 mg, or 40 mg capsules administered orally
16158630|NCT01713569|Device|Ulthera Treatment|Focused ultrasound energy delivered below the surface of the skin
16158631|NCT01713556|Drug|Propranolol|
16158632|NCT01713556|Other|Trauma reactivation|Trauma reactivation: script-driven mental imagery of the traumatic event
16158633|NCT01713556|Drug|placebo|
16158634|NCT01713543|Other|physical therapy|Tailored physical therapy sessions to modify impairments in balance and/or gait and to transition high-risk participants to an evidence-based group exercise program.
16158635|NCT01713530|Drug|insulin degludec/insulin aspart|Dose individually adjusted. For subcutaneous (s.c, under the skin) administration twice a day.
16158636|NCT01713530|Drug|insulin degludec|Dose individually adjusted. For subcutaneous (s.c, under the skin) administration once daily.
16158637|NCT01713530|Drug|insulin aspart|Dose individually adjusted. For subcutaneous (s.c, under the skin) administration with the main meals 2-4 times daily in accordance with local labelling.
16158757|NCT01712555|Procedure|autologous fat grafting with PRP to anophthalmic orbits|
16159249|NCT01709110|Drug|Calcium|Administered orally
16158638|NCT01713517|Other|Indoor residual insecticide spraying (IRS)|Application of insecticide to interior walls of domiciliary structures to kill malaria vector mosquitoes which rest on walls after taking human blood meal
16158639|NCT01713517|Device|Long Lasting Insecticidal Nets (LLIN)|Provision of LLIN to all community members in the clusters allocated to the study arm. LLIN protect individuals from bites by malaria vector mosquitoes by providing a physical barrier and insecticidal and repellent effect.
16158640|NCT01713504|Biological|biologie sample|comparison of biomarkers between HES, HE biomarkers data and control arms
16158641|NCT01713478|Other|echocardiography|The patients and controls will be investigated by echocardiography, biomarkers, and ECG. After 1 year investigators will assess 1year mortality.
16158642|NCT01713465|Other|Computer based Metabolic Syndrome educational program|Individuals in the intervention group will receive metabolic syndrome related education using a touch screen interactive and bilingual multimedia enabled educational program
16158643|NCT01713452|Procedure|Purse string closure|"An incision around the stoma will be made with 2-3 mm circumferential margins. This dissection along the mucocutaneous junction will then be made to the fascial defect. Re-establishment of bowel continuity will them be performed. If the circumferential incision does not provide adequate exposure, the incision can be converted to an elliptical one. Thereafter, it will be closed primarily with staples, similar to the primary closure group.
~Following ostomy closure, the subcutaneous tissues will be irrigated. A 2-0 monocryl subcuticular purse string stitch will then be placed and cinched to a 1cm diameter. This opening will then be packed with Nu-Gauze as a wick dressing.
~Diameter of the skin defect should then be measured.
~A postoperative photo will then be taken."
16158644|NCT01713452|Procedure|Primary closure|"An elliptical incision (extending transversely) will be made with 2-3 mm superior/inferior margins around the mucocutaneous junction. Dissection will then be made in a perpendicular fashion through the subcutaneous tissue with tapering near the fascial defect. Re-establishment of bowel continuity will then be performed.
~Following ostomy closure, the subcutaneous tissue will be irrigated and the skin will be closed tight with staples placed at close intervals (<1.5cm). No subcutaneous drains will be placed.
~Length of the incision should be measured in centimeters.
~A postoperative photo will then be taken."
16158645|NCT01713439|Biological|Injection of allogeneic neuroblastoma cells|Patients will receive a fixed dose of IL-2 gene modified tumor cells (10^7/kg, 10^8 max) already shown to be safe from a previous protocol, and an escalating dose of Lptn transduced tumor cells, beginning at 10^4/kg and rising to 10^7/kg (10^8 max). Patients will be assigned to an appropriate dose level for injection # 1. Injection #2 will contain 10 times more Lptn transduced cells than injection #1, until the max dose (10^8) has been reached in the first injection. The dose of injections 3 through 8 will be the same as the dose of injection #2. Initial injection volumes will be <1ml and should be injected in a single site. Only if these first patients show no undue local toxicity (including tumor cell growth) will multiple injection sites be used for subsequent high cell-dose studies.
16158646|NCT01713426|Drug|Qutenza|Cutaneous patch
16158647|NCT01713426|Drug|Pregabalin|Oral capsule
16158648|NCT01713413|Device|Oxymizer|Using first the Oxymizer and 24 h later the conventional nasal cannula.
16158649|NCT01713413|Device|conventional nasal cannula|Using first the conventional nasal cannula and 24h later the Oxymizer
16158650|NCT01713400|Drug|Ustekinumab|One subcutaneous injection administered on day -1 and repeated on day +20 after transplant
16158651|NCT01713400|Drug|Placebo|Subcutaneous injection of sterile saline (identical volume to that of ustekinumab) administered via the identical route and schedule as ustekinumab.
16158652|NCT01713400|Drug|Tacrolimus (TAC)|Administered starting day -3 according to Blood and Marrow Transplant (BMT) Program standard operating procedures. TAC levels to be monitored and maintained at a target range of 3-7 given concurrent administration with sirolimus. Specific dose adjustments within this therapeutic range to be determined by the treating physician.
16158653|NCT01713400|Drug|Sirolimus|Administered initially as an oral loading dose on day -1. Thereafter, SIR to be administered as an oral regimen daily. The dose for both loading and ongoing administration to be dictated by the standard operating procedures of the BMT program. SIR levels to be monitored according to standard procedures. Dose adjustments to be made according to drug levels, with target range of 5-14ng/mL (therapeutic range by Abbott Architect instrument at Moffitt).
16158654|NCT01713387|Drug|Gemcitabine, S-1|Dose of gemcitabine and S-1 and treatment schedule
16158655|NCT01713374|Procedure|Mental stress|Subjects will be asked to perform complex mathematic operations at a very fast pace
16158656|NCT01713374|Other|no intervention|control visit
16158657|NCT01713374|Procedure|Myogenic activation|A pneumatic cuff will be inflated to suprasystolic pressure around both thighs and the subjects will be asked to perform plantar flexion exercises.
16158658|NCT01713374|Procedure|Cold pressure test|A hand will be placed in ice-cold water.
16158659|NCT01713361|Drug|ISIS-FXIRx Dose #2|Group B: ISIS-FXIRx dose #2 subcutaneously administered 7 times prior to total knee arthroplasty, and 2 times after surgery.
16158660|NCT01713361|Drug|ISIS-FXIRx Dose #3|Group C: ISIS-FXIRx dose #3 subcutaneously administered 7 times prior to total knee arthroplasty, and 2 times after surgery.
16158661|NCT01713361|Drug|Enoxaparin|Enoxaparin (40mg) will be administered by subcutaneous injection the evening prior to total knee arthroplasty (optionally), 6 to 8 hours after surgery, followed by daily injections for at least 8 additional days post surgery (a total of at least 9 consecutive days). [Except for Canadian region, in which the subcutaneous injection of enoxaparin the evening prior to total knee arthroplasty is expected, resulting in a total of at least 10 consecutive days of enoxaparin.]
16158662|NCT01713348|Device|FreeStyle Navigator|Masked CGM day 1 to 15, unmasked CGM days 15 to 100
16158663|NCT01713348|Device|Standard SMBG|Masked CGM days 1 to 15, standard SMBG days 15 to 86, masked CGM day 86 to 100
16158664|NCT01713322|Behavioral|Pain management education|Parents are provided with educational material on how to manage child pain during immunization.
16158665|NCT01713322|Behavioral|No pain management education|Control - parents receive general information about childhood immunization.
16158666|NCT01713309|Drug|Filgrastim|Filgrastim 300 ug daily for 7 days, subcutaneously.
16158667|NCT01713296|Drug|Pazopanib|
16158668|NCT01713283|Drug|SOF|Sofosbuvir (SOF) 400 mg tablet administered orally once daily
16158823|NCT01712100|Drug|Avapro|
16159045|NCT01710501|Drug|Grazoprevir|Grazoprevir tablet, orally, once per day at assigned dose
16158669|NCT01713283|Drug|RBV|Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
16158670|NCT01713270|Procedure|renal sympathetic denervation|Contrast renal angiography was performed to localize and assess the renal arteries for accessibility and appropriateness for RSD. Once the anatomy was deemed acceptable, the internally irrigated radiofrequency ablation catheter(Celsius Thermocool, Biosense Webster, Diamond Bar, California) was introduced into each renal artery. then was maneuvered within the renal artery to allow energy delivery in a circumferential, longitudinally staggered manner to minimize the chance of renal artery stenosis. About four to eight ablations at 10 W for 1 minute each were performed in both renal arteries. During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm.
16158671|NCT01713270|Drug|drug|Angiotensin converting enzyme inhibitors, angiotensin receptor antagonist, calcium antagonists, diuretic, beta adrenoceptor blocking agents, propafenone, amiodarone
16158672|NCT01713270|Procedure|Direct-Current Cardioversion|After renal sympathetic denervation, Persistent AF individual (except intracardiac thrombus) accept Direct-Current Cardioversion within one week. anticoagulation (INR 2.0 to 3.0) is recommended for at least 3 weeks prior to and 4 weeks after cardioversion.
16158673|NCT01713257|Dietary Supplement|Immunoenhancing diet|Enteral feeding until Day 10 or the day of discharge if earlier than Day 10. The goal of caloric intake is 25 kcal/kg/day and protein 1.2 g/kg/day.
16158674|NCT01713257|Dietary Supplement|Isocaloric, isonitrogenous diet|Enteral feeding until Day 10 or the day of discharge if earlier than Day 10. The goal of caloric intake is 25 kcal/kg/day and protein 1.2 g/kg/day.
16158675|NCT01713244|Procedure|RFA assisted Hepatectomy|Using RFA to ablate and block the small vessels around the tumor before resection to reduce the spreading of the cancer cell.
16158676|NCT01713244|Procedure|Hepatectomy|Treat the advanced HCC with the hepatectomy only.
16158677|NCT01713231|Dietary Supplement|standard-dose vitamin D (400IU per day)|
16158678|NCT01713231|Dietary Supplement|high-dose vitamin D (2000 IU per day)|
16158679|NCT01713218|Drug|gemcitabine|Administrated intravenously at a dose of 1000 mg/m2 over 30 minutes weekly, week 1 to 4
16158680|NCT01713218|Drug|Vismodegib|150 mg capsule, oral, once daily
16158681|NCT01713218|Procedure|Neoadjuvant chemotherapy|Combination of gemcitabine and Vismodegib during a window interval (4 weeks) before surgery
16158682|NCT01713179|Drug|Ambroxol hydrochloride (Mucopect®, 60 mg, Boehringer Ingelheim)|
16158683|NCT01713166|Drug|plasmalyte solution|plasmalyte solution
16158684|NCT01713166|Drug|Hextend|Hetastarch administration instead of crystalloids until the total amount given reached 20 ml/kg, which is the maximally allowed daily dose. Afterward, plasmalyte solution infusion to meet the fluid requirements.
16158685|NCT01713153|Drug|Misoprostol|600 mcg misoprostol oral
16158686|NCT01713153|Device|UnijectTM|10 IU oxytocin delivered intramuscularly with UnijectTM
16158687|NCT01713140|Other|1 strength training set performed until contraction failure|Electromyographic (EMG) activity of the vastus medialis (VM), vastus lateralis (VL), semitendinosus (ST) and biceps femoris (BF) muscles will be recorded during knee extensions performed in a knee extension machine in a single set performed until contraction failure. The relative loading will be 10 repetition maximum (RM). The absolute load (kilograms) corresponding to 10 RM is defined a minimum of 3 days before the day where the EMG-data are recorded. Range of motion and time under tension for each repetition will be controlled for.
16158688|NCT01713127|Drug|remifentanil infusion|
16158689|NCT01713127|Drug|Placebo|
16158690|NCT01713114|Other|Acute measures of satiety and food intake at next meal|
16158691|NCT01713101|Drug|Early intravenous tranexamic acid administration|Initial history taking and physical examination --> enrollment --> 1g bolus over 10 minutes followed slow infusion over 8 hours.
16158692|NCT01713101|Drug|placebo|
16158693|NCT01713088|Other|Multisystemic therapy|
16158694|NCT01713088|Other|YOT (usual services)|
16158695|NCT01713062|Device|Vitelene|THA
16158696|NCT01713062|Device|XLPE|THA
16158697|NCT01713049|Drug|18F-FLT|0.07 mCi/kg of 18F-FDG will be injected intravenously. The data acquisition will be started at 90 minutes after the injection using 2-D acquisition from a GE DISCOVERY ST PET/CT scanner (GE Medical Systems, Milwaukee, WI).
16158698|NCT01713036|Drug|Pimasertib|Part A: Subjects will receive unlabeled pimasertib capsules orally at a single dose of 60 milligram (mg) on Day 1. One hour after administration of the oral unlabeled pimasertib dose, the intravenous (IV) tracer dose of 9 kilobecquerel (kBq) [14C] pimasertib will be administered as a bolus injection. On Days 3-21 (except Day 8), subjects will receive unlabeled pimasertib capsules orally at a dose of 60 mg twice daily (BID). In the morning of Day 8, subjects will receive 60 mg unlabeled pimasertib capsules spiked with a dose of 2.6 megabecquerel (MBq) (70 microcuries [mcgCi]) of [14C] pimasertib orally. In the evening of Day 8, subjects will receive the evening dose of 60 mg pimasertib as unlabeled pimasertib capsules orally. Part B : Subjects will be administered with 60 mg BID unlabeled pimasertib as oral capsules continuously in cycles of 21 days until progression of the disease, unacceptable toxicity, withdrawal of consent by the subject, loss to follow-up or death.
16158699|NCT01713023|Dietary Supplement|Glucose|The same described in Arm description
16158700|NCT01713023|Dietary Supplement|Fructose|The same described in Arm description
16158701|NCT01713010|Other|Predictive indexes of weaning from mechanical ventilation|
16158702|NCT01712997|Drug|Iloprost|
16158703|NCT01712997|Drug|Bosentan|
16158704|NCT01712984|Biological|Influenza Virus Vaccine USP Quadrivalent, (Zonal Purified Subvirion) 2012 2013 Formulation|0.1mL, Intradermal
16158705|NCT01712984|Biological|Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® Intradermal|0.1mL, Intradermal
16158706|NCT01712984|Biological|Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone Intradermal|0.1mL, Intradermal
16158707|NCT01712945|Drug|Palifermin|Palifermin (Kepivance®) administered by intravenous bolus on days -5, -4. -3 prior to, and on days 8, 9 and 10 after each cycle of alemtuzumab, then again on 3 consecutive days at month 1 and month 3 after each cycle of alemtuzumab. Patients will be observed for adverse reactions for at least 1 to 2 hours following each bolus dose.
16159250|NCT01709110|Drug|Vitamin D|Administered orally
16158708|NCT01712945|Drug|Alemtuzumab|Initial treatment alemtuzumab will be administered as a fixed total dose of 60 mg IV over 5 consecutive days (12mg/day). For re-treatment at Month 12, alemtuzumab will be administered as a fixed total dose of 36mg IV over 3 consecutive days (12mg/day).
16158709|NCT01712919|Radiation|Intensity-modulated radiotherapy|Patients will be given intensity-modulated radiotherapy(IMRT)
16158710|NCT01712919|Drug|Concurrent chemotherapy with paclitaxel and nedaplatin|Patients will be given 2 cycles of concurrent chemotherapy with paclitaxel and nedaplatin
16158711|NCT01712919|Biological|Cetuximab|Patients will be given cetuximab weekly during radiation therapy
16158712|NCT01712906|Biological|3.50±0.25logCCID50/ml|Attenuated Mumps vaccine (KMB-17) of 3.50±0.25logCCID50/ml in adults (16-59 years old)，children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.
16158713|NCT01712906|Biological|4.25±0.25 logCCID50/ml|Attenuated Mumps vaccine (KMB-17) of 4.25±0.25 logCCID50/ml in adults (16-59 years old)，children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.
16158714|NCT01712906|Biological|5.00±0.25 logCCID50/ml|Attenuated Mumps vaccine (KMB-17) of 5.00±0.25 logCCID50/ml in adults (16-59 years old)，children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.
16158715|NCT01712906|Biological|0 logCCID50/ml|0 logCCID50/ml in adults (16-59 years old)，children (5-15 years old or 2-4 years old) and infants (8-23 months old) on day 0.
16158716|NCT01712906|Biological|Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1)|Attenuated Mumps vaccine (Zhe Jiang Vacn Bio-pharmaceutical Co., LTD.; NO.20110528-1) in children (2-4 years old) and infants (8-23 months old) on day 0.
16158717|NCT01712893|Drug|Zoladex|Eligible patients were randomly divided into 2 groups, the intervention group should use Zoladex 3.6mg once a month up to 2-3 years combined with chemotherapy,and the control group should use chemotherapy alone followed by Zoladex
16158718|NCT01712880|Procedure|open debridement with modular exchange|
16158719|NCT01712880|Procedure|one stage exchange|
16158720|NCT01712867|Other|Omega-3 acid ethyl esters|4 capsules/day for 12 weeks
16158721|NCT01712867|Other|Phytosterol esters of omega-3|4 capsules/day for 12 weeks
16158722|NCT01712854|Drug|Budesonide|budesonide 80 mcg
16158723|NCT01712854|Drug|Symbicort|A combination of budesonide and long acting beta agonist: Budesonide 80 mcg and formoterol fumarate dihydrate inhaler 4.5 mcg
16158724|NCT01712828|Drug|Lenalidomide|25 mg Lenalidomide capsule will be administered orally once in the first period, and once with Quinidine in the second period
16158725|NCT01712828|Drug|Quinidine|300 mg of Quinidine will be administered orally every 12 hours for 1 day followed by 600 mg of Quinidine administered orally every 12 hours for the next 4 consecutive days
16158726|NCT01712828|Drug|Temsirolimus|25 mg/mL injection of Temsirolimus will be given directly into the vein over 30 minutes once in the second period and once with Lenalidomide in the third period.
16158727|NCT01712828|Drug|Diphenhydramine|Just before Temsirolimus is given, 25 mg of Diphenhydramine (Benadryl) will be given directly into the vein to decrease chances of an allergic reaction to Temsirolimus.
16158728|NCT01712815|Other|laboratory biomarker analysis|Correlative studies
16158729|NCT01712815|Other|pharmacological study|Correlative studies
16158730|NCT01712815|Other|questionnaire administration|Ancillary studies
16158731|NCT01712815|Radiation|fluorine F 18-clevudine|Undergo fluorine F 18-clevudine PET/CT scan
16158732|NCT01712815|Procedure|positron emission tomography/computed tomography|Undergo fluorine F18-clevudine PET/CT scan
16158733|NCT01712802|Other|Denture Adhesives: Cream|Using Polident as denture adhesive to compare its effect on PRO and subjective outcomes.
16158734|NCT01712802|Other|Denture Adhesives: Powder|Using Poligrip powder as denture adhesive to compare its effect on PRO and subjective outcomes.
16158735|NCT01712802|Other|Saline|work as control for Denture Adhesives: Cream and Powder
16158736|NCT01712789|Drug|Pomalidomide|Oral Pomalidomide at the starting dose of 4 mg on Days 1-21 of a 28-day cycle
16158737|NCT01712789|Drug|Dexamethasone|Oral Low dose Dexamethasone at the starting dose of 40mg/day (≤ 75 years old) or 20 mg/day (> 75 years old) on Days 1, 8, 15 and 22 of a 28-day cycle.
16158738|NCT01712776|Device|Vapocoolant (Pain Ease)|Topical stream 4-10 seconds duration to skin.
16158739|NCT01712776|Device|Nature's Tears Sterile Water|Topical stream 4-10 seconds duration to skin
16158740|NCT01712763|Drug|degarelix|50 women will be treated with degarlix 80 mg, in only one administration covering three months
16158741|NCT01712763|Drug|goserelin|50 women will be treated with decapeptyl 3.6 every month for three months
16158742|NCT01712737|Other|Dietary intervention|
16158743|NCT01712724|Other|combined resistance and aerobic training|For the group randomized to AT+RT, Patients will gradually be progressed from 1-2 sets and then from 10-15 repetitions and then increase resistance by 1.6-5 kg or increase the exercise band level and then reduced repetitions to 10 and repeated this process.
16158744|NCT01712711|Drug|H.pylori eradication|The regimen consists of Omeprazole (20 mg/BD)+ Amoxicillin (1 g/day)+ Bismuth subcitrate (240 mg/BD)+ Azithromycin (500 mg/BD)for two weeks
16158745|NCT01712685|Drug|18F-VM4-037|Drug being tested for use in cancer imaging studies. It may help tumor tissue show up more clearly during scans.
16158746|NCT01712685|Procedure|PET/CT|
16158747|NCT01712659|Drug|Ruxolitinib|Ruxolitinib 20 mg orally twice daily for 28 days. Patient may continue to receive treatment until PD.
16158748|NCT01712659|Drug|ruxolitinib|ruxolitinib 30-50 mg orally twice daily for 28 days. Patients may continue to receive treatment until PD or unacceptable toxicity
16158749|NCT01712646|Drug|Intranasal Oxytocin|
16158750|NCT01712620|Drug|Spironolactone|Initial dose, 25 mg (pink capsule) orally, daily. If well tolerated at 7-9 wks then increased to 50 mg (brown capsule) daily.
16158751|NCT01712620|Drug|Placebo|Initial dose, pink sugar capsule, daily. If well tolerated at 7-9 wks then changed to brown sugar capsule, daily.
16158752|NCT01712607|Other|Preoperative Warm-Up training|Preoperative Warm-Up training
16158753|NCT01712594|Device|Closed Loop Procedure (Medtronic)|The procedure A is the device running under normal conditions, procedure B will incorporate an induced calibration error.
16158754|NCT01712581|Other|Magnetic Resonance Imaging|
16158755|NCT01712568|Drug|Test Product (Ropinirole)|"one Tablet at 0 hour"
16158758|NCT01712529|Behavioral|Supervised physical exercise|Women with systemic lupus erythematosus with availability to perform physical exercise were allocated in exercise group (EG) to practice supervised physical exercise for one hour, three times a week for 16 weeks. Those who were not available for this activity were allocated in the control group (CG). Intervention consisted of walking at speed of the ventilatory threshold-1 heart rate obtained from cardiopulmonary exercise test and monitored by frequency meter.
16158759|NCT01712516|Drug|QVA149|QVA149 was supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI
16158760|NCT01712516|Drug|QAB149|QAB149 was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.
16158761|NCT01712516|Drug|NVA237|NVA237 was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.
16158762|NCT01712516|Drug|Placebo|Placebo was supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI.
16158763|NCT01712503|Device|Phacoemulsfication cataract surgery and intra-ocular lens implant|
16158764|NCT01712490|Drug|brentuximab vedotin|Brentuximab vedotin (ADCETRIS®)1.2 mg/kg by IV infusion on Days 1 and 15 of each 28-day cycle.
16158765|NCT01712490|Drug|doxorubicin|Doxorubicin: 25 mg/m^2 by IV infusion on Days 1 and 15 of each 28-day cycle.
16158766|NCT01712490|Drug|bleomycin|Bleomycin: 10 units/m^2 by IV infusion on Days 1 and 15 of each 28-day cycle.
16158767|NCT01712490|Drug|vinblastine|Vinblastine: 6 mg/m2 will be administered by IV infusion on Days 1 and 15 of each 28-day cycle
16158768|NCT01712490|Drug|dacarbazine|Dacarbazine (DTIC): 375 mg/m^2 by IV infusion on Days 1 and 15 of each 28-day cycle.
16158769|NCT01712477|Drug|Intravenous sedation using propofol|Patients will be given intravenous sedation for treatment of traumatic brain injury requiring mechanical ventilation
16158770|NCT01712477|Drug|Intravenous sedation with midazolam|patients with severe traumatic brain injury requiring mechanical ventilation and sedation will be sedated with midazolam
16158771|NCT01712464|Drug|Oxytocin vs. Placebo|FMRI measurement and blood examinations after 26 IU Oxytocin (Syntocinon)or placebo on two consecutive days
16158772|NCT01712451|Drug|salmeterol xinafoate, fluticasone propionate|LIPO-102
16158773|NCT01712451|Drug|Placebo|Placebo
16158774|NCT01712451|Drug|salmeterol xinafoate|Salmeterol
16158775|NCT01712438|Biological|Human cl rhFVIII|
16158776|NCT01712425|Biological|0-24 week prime/boost regimen|ChAdV63.HIVcons (5x10^10 vp) and MVA.HIVconsv (2x10^8 pfu) HIV-1 vaccines, delivered intramuscularly
16158777|NCT01712425|Biological|0-8 week prime/boost regimen|ChAdV63.HIVcons (5x10^10 vp) and MVA.HIVconsv (2x10^8 pfu) HIV-1 vaccines, delivered intramuscularly
16158778|NCT01712412|Drug|IW-9179|
16158779|NCT01712412|Drug|Placebo|
16158780|NCT01712399|Biological|Mavrilimumab 100 mg|Participants will receive 100 mg mavrilimumab once in every 2 weeks (Q2W) subcutaneously for up to 3 years
16158781|NCT01712386|Dietary Supplement|Beetroot|
16158782|NCT01712386|Dietary Supplement|Beetroot placebo|
16158783|NCT01712373|Drug|Ginseng|it is kind of drug
16158784|NCT01712373|Drug|Placebo|it is placebo
16158785|NCT01712360|Drug|NAFT500 (pediatric)|Applied to both feet and groin area
16158786|NCT01712360|Drug|NAFT600 (pediatric)|Applied to both feet only
16158787|NCT01712360|Drug|NAFT500 (adult)|Applied to both feet and groin area
16158788|NCT01712360|Drug|NAFT600 (adult)|Applied to both feet
16158789|NCT01712347|Drug|Bevacizumab|Bevacizumab will be administered as per approved label.
16158790|NCT01712347|Drug|Chemotherapy|The protocol does not specify the chemotherapy regimen to be used, the choice of chemotherapy will be at the discretion of treating physician.
16158791|NCT01712334|Drug|dornase alfa [Pulmozyme®]|Inhaled once daily by Pari eRapid nebulizer.
16158792|NCT01712334|Drug|dornase alfa [Pulmozyme®]|Inhaled once daily by Pari LC Plus jet nebulizer.
16158793|NCT01712321|Drug|Vilazodone|Vilazodone 20mg or 40mg taken once daily by mouth
16158794|NCT01712321|Drug|Placebo|Placebo matching Vilazodone 20mg or 40mg, taken once daily by mouth
16158795|NCT01712308|Other|Laboratory Biomarker Analysis|Correlative studies
16158796|NCT01712308|Biological|Sotatercept|Given SC
16158797|NCT01712295|Drug|17% Salicylate with ethyl pyruvate|
16158798|NCT01712295|Drug|Salicylates|
16158799|NCT01712282|Behavioral|physical activity, 2 x 30 minutes/day|weight-bearing treadmill, pulse reserve increase of 50%
16158800|NCT01712269|Procedure|Weight-loss (bariatric) surgery|Subjects will undergo bariatric surgery which will assist weight loss
16158801|NCT01712256|Biological|Vacc-4x|Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
16158802|NCT01712243|Other|Light|
16158803|NCT01712230|Drug|GnRH agonist|"Drug: leuprolide acetate
~Other Names:
~Lupron 3.75 mg for depot suspension delivered by monthly intramuscular injection for 6 months"
16158804|NCT01712230|Behavioral|Supervised cardiovascular exercise|Supervised exercise, 4 days per week for 45 to 60 minutes per session for 6 months
16158805|NCT01712230|Drug|Placebo|Placebo
16158806|NCT01712217|Drug|AT13387|HSP90 inhibitor
16158807|NCT01712217|Drug|Crizotinib|ALK (anaplastic lymphoma kinase) and ROS1 (c-ros oncogene1, receptor tyrosine kinase) inhibitor
16158808|NCT01712204|Drug|Placebo|Placebo Capsule BID for 16 Weeks
16158809|NCT01712204|Drug|AC-201|AC-201 50mg Capsule BID for 16 Weeks
16158810|NCT01712204|Drug|Febuxostat|Febuxostat 80 mg QD for 16 Weeks
16158811|NCT01712191|Device|NUsurface Meniscus Implant|
16158812|NCT01712178|Biological|Adalimumab, current formulation|Current formulation adalimumab 40 mg every other week
16158813|NCT01712178|Biological|Adalimumab, new formulation|New formulation adalimumab 40 mg every other week
16158814|NCT01712165|Dietary Supplement|ANMUM Materna|
16158815|NCT01712165|Dietary Supplement|Control (milk powder)|
16158816|NCT01712139|Drug|Irbesartan and Hydrochlorothiazide|
16158817|NCT01712139|Drug|Avalide|
16158818|NCT01712126|Drug|Irbesartan and Hydrochlorothiazide|
16158819|NCT01712126|Drug|Avalide|
16158820|NCT01712113|Drug|Irbesartan|
16158821|NCT01712113|Drug|Avapro|
16158822|NCT01712100|Drug|Irbesartan|
16158824|NCT01712087|Device|MedStream Programmable Infusion System|Intrathecal Infusion of Baclofen in the Treatment of Spasticity
16158825|NCT01712074|Drug|PF-05212377 (SAM-760)|30 mg QD of PF-05212377 (SAM-760)
16158826|NCT01712074|Other|Placebo|Placebo QD
16158827|NCT01712061|Drug|PF-04634817|Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function
16158828|NCT01712061|Drug|Placebo|Three or four tablets (50mg) daily for 12 weeks, depending on baseline renal function
16158829|NCT01712048|Procedure|Submucosal Injection EMR|"Selective saline injection is applied to the layer of tissue underneath the polyp in order to create a safety cushion for resection. EMR is then performed with a standard snare."
16158830|NCT01712048|Procedure|Underwater EMR|Polypectomy is performed under full water emersion without the use of submucosal injection.
16158831|NCT01712009|Drug|Naproxen|
16158832|NCT01712009|Drug|Loratadine|
16158833|NCT01712009|Biological|Pegfilgrastim|Commercially available pegfilgrastim (Neulasta®) will be used in the study, and is considered background therapy. Pegfilgrastim is administered as a single 6 mg subcutaneous injection 24 hours to 72 hours after completion of chemotherapy.
16158834|NCT01712009|Drug|Chemotherapy|The choice of chemotherapy regimen (agent, dose, and schedule) is at the discretion of the treating physician.
16158835|NCT01711983|Device|GORE® CARDIOFORM Septal Occluder|Percutaneous Atrial Septal Defect Closure
16158836|NCT01711970|Drug|Paclitaxel|
16158837|NCT01711957|Procedure|Liver transplantation|Standardized technique of liver transplantation Organ procurement follow the rules of the Swiss transplant society
16158838|NCT01711944|Behavioral|Problem-Solving Skills Training|8-session manualized intervention to provide problem-solving skills training in the context of childhood cancer.
16158842|NCT01711918|Drug|Domperidone|oral tablet; dose is 10mg per tablet given up to 3 times daily.
16158843|NCT01711905|Dietary Supplement|Vitamin D3|daily dosage of 20 µg Vitamin D3 for 12 weeks
16158844|NCT01711892|Behavioral|Soccer training|
16158845|NCT01711879|Drug|Aflibercept|Details covered in arm description
16158846|NCT01711866|Drug|Rotigotine|Rotigotine up to 16 mg / 24 hours, 4 weeks.
16158847|NCT01711853|Drug|Dabigatran Etexilate|Dabigatran Etexilate 75mg twice daily
16158848|NCT01711827|Drug|Isavuconazole|oral
16158849|NCT01711827|Drug|Prednisone|oral
16158850|NCT01711814|Drug|peficitinib|oral
16158851|NCT01711801|Drug|Placebo|Single ascending dose
16158852|NCT01711801|Drug|RO5545965|Single ascending dose
16158853|NCT01711801|Drug|RO5545965|Single dose, in fed and fasted state
16158854|NCT01711788|Procedure|Intrabone infusion of umbilical cord blood stem cells|
16158855|NCT01711775|Drug|aleglitazar|Single oral dose Day 1, repeated oral dose once daily Days 5-14
16158856|NCT01711762|Drug|GDC-0973|Single oral dose of [14C]-GDC-0973
16158857|NCT01711749|Drug|Crestor®|Reference formulation is rosuvastatin calcium tablets, 20mg, currently commercialized by AstraZeneca do Brasil Ltda., under the trademark Crestor®
16158858|NCT01711749|Drug|rosuvastatin calcium tablets|Test formulation is rosuvastatin calcium tablets, 20 mg, produced by Laboratorios Phoenix S.A.I.C.F/Argentina for GlaxoSmithKline Brasil Ltda.
16158859|NCT01711736|Biological|Quadrivalent influenza GSK2282512A vaccine|1 or 2 doses administered intramuscularly (IM) in deltoid muscle or anterolateral thigh on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects) respectively.
16158860|NCT01711736|Biological|Fluarix|1 or 2 doses administered IM in deltoid muscle or anterolateral thigh, on Day 0 (primed subjects) and on Day 0 and Day 28 (unprimed subjects) respectively.
16158861|NCT01711723|Drug|Darapladib 160 mg|Subjects in each group received one tablet orally of Darapladib 160 mg daily for 10 consecutive days. Tablets were taken with food, swallowed whole, not chewed.
16158862|NCT01711710|Device|Cohesive Gel Breast Implant|"Cohesive Silicone Gel-Filled Breast Implant insert under the submuscular with axillary incision in breast augmentation mammoplasty.
~Remove tissue expander and insert Cohesive Silicone Gel-Filled Breast Implant in breast reconstruction."
16158863|NCT01711697|Radiation|stereotactic body radiation therapy|Undergo SBRT
16158864|NCT01711697|Drug|carboplatin|
16158865|NCT01711697|Drug|paclitaxel|
16158866|NCT01711697|Radiation|radiation therapy|Undergo radiation therapy
16158867|NCT01711684|Drug|Diphenylcyclopropenone (DPCP)|Topical application of study drug
16158868|NCT01711671|Drug|DKN-01 300 mg|300 mg IV infusion of DKN-01 administered twice per 28 day cycle on Days 1 and 15, plus lenalidomide/dexamethasone
16158869|NCT01711671|Drug|DKN-01 600 mg|600 mg IV infusion of DKN-01 administered twice per 28 day cycle on Days 1 and 15, plus lenalidomide/dexamethasone
16158870|NCT01711671|Drug|Standard of Care|Current approved standard of care
16158871|NCT01711658|Radiation|Intensity Modulated Radiation Therapy (IMRT)|70 Gy in 2 Gy fractions
16158872|NCT01711658|Drug|Cisplatin|100 mg/m2 on days 8 and 29
16158873|NCT01711658|Drug|placebo|1500 mg daily one week prior to radiation, followed by 1500 mg daily concurrent with radiation, followed by 1500 mg daily for 3 months
16158874|NCT01711658|Drug|Lapatinib|1500 mg daily one week prior to radiation, followed by 1500 mg daily concurrent with radiation, followed by 1500 mg daily for 3 months
16158875|NCT01711645|Biological|Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed onto aluminum phosphate|55 postpartum subjects receive a single intramuscular (IM) 0.5 mL dose of Adacel® (Tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed).
16158917|NCT01711476|Other|Active Comparator: Lifestyle counseling ARM 1|In the Arm 1 we will measure androgen levels and insulin and glucose response to OGTT at baseline DAY 0 and after 90 days on the dinner diet (Day 90) for comparison Also we will evaluate by weekly progesterone the ovulatory events
16158918|NCT01711463|Drug|Fluticasone Furoate/Vilanterol|50/25 or 100/25 or 200/25 mcg inhaled once daily for 7 days in each treatment period.
16158919|NCT01711463|Drug|Placebo|Placebo inhaled once daily for 7 days in each treatment period.
16159443|NCT01707628|Biological|influenza vaccination with influenza vaccine|
16158876|NCT01711632|Drug|Vemurafenib|Patients will receive vemurafenib at a dose of 960mg orally b.i.d. continuously in cycles of 4 weeks (28 days) as outpatient. A bone marrow aspirate and/or biopsy will be performed after the first cycle for research purposes only. After the completion of the third cycle, a repeat bone marrow aspirate and/or biopsy will be performed for assessment of response and evaluation of MRD. Following the third cycle assessments, patients who achieve complete response (CR) with detectable MRD or partial response (PR) may continue with vemurafenib for up to 3 additional cycles at the treating physician's discretion (Cycles 4-6). Patients who achieve CR without MRD will be observed as part of post-treatment followup, and may be re-treated with vemurafenib after relapse (as per below). Patients who achieve no response (NR) after the initial 3 cycles of vemurafenib will be removed from the study. They will be followed every 3 months as part of posttreatment followup for a total of 12 months.
16158877|NCT01711619|Device|subcutaneous nerve stimulation|subcutaneous nerve stimulation plus optimized medical management
16158878|NCT01711619|Other|Optimized Medical Management|Optimized medical management
16158879|NCT01711593|Biological|Bronchoscopy, Segmental Allergen Challenge and Bronchoalveolar Lavage|On the first bronchoscopy day,BAL will first be performed in the lingual without instillation of diluent or allergen. A 2ml aliquot of isotonic diluent is instilled into the right upper lobe.The procedure is repeated in the right middle lobe with instillation of 2ml of standardized cat or mite allergen solution. A test dose concentration of allergen is administered first consisting of 2 ml of allergen at 1/10th(Cat,D.farinae)or 1/30th(D.pteronyssinus)the threshold concentration.If on visual inspection through the bronchoscope there is no evidence of mucosal inflammation after 2 minutes a second segmental allergen challenge will be done in the right middle lobe using 2ml of full-dose allergen at the threshold concentration(Cat,D.farinae)or 1/3 the threshold concentration(D.pteronyssinus). This dose will be predetermined by quantitative skin prick testing.A second bronchoscopy is performed 24 hours after delivery of allergen extract and diluent to obtain BAL fluid from the RUL and RML.
16158880|NCT01711593|Procedure|Phlebotomy|200 (40 teaspoons) ml of blood will be obtained from the subjects to collect different leukocyte populations. A second 200 ml of blood will be obtained from the Track 2 subjects 4 weeks later for isolation of T lymphocytes for functional studies.
16158881|NCT01711580|Other|EORTC QLQ-C30|The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. It is supplemented by disease specific modules for e.g. Breast, Lung, Head & Neck, Oesophageal, Ovarian, Gastric, Cervical cancer, Multiple Myeloma, Oesophago-Gastric, Prostate, Colorectal Liver Metastases, Colorectal and Brain cancer which are distributed from the EORTC Quality of Life Department. Other disease specific modules are under development but not yet validated.
16158882|NCT01711580|Other|EORTC QLQ-BN20|The EORTC QLQ-C30 is a questionnaire developed to assess the quality of life of cancer patients. It is supplemented by disease specific modules for e.g. Breast, Lung, Head & Neck, Oesophageal, Ovarian, Gastric, Cervical cancer, Multiple Myeloma, Oesophago-Gastric, Prostate, Colorectal Liver Metastases, Colorectal and Brain cancer which are distributed from the EORTC Quality of Life Department. Other disease specific modules are under development but not yet validated.
16158883|NCT01711580|Other|Hopkins Verbal Learning Test-Revised (HVLT-R)|The HVLT-R is a cognitive test to assess verbal learning and memory.
16158884|NCT01711580|Other|Stroop color-word test|The Stroop Color and Word Test is a brief five minute test which is used to assess brain dysfunction, cognition, and psychopathology.
16158885|NCT01711580|Other|Controlled oral word association test (COWA)|The COWA is a measure of verbal fluency that requires expressive language and executive functions.
16158886|NCT01711580|Other|Jamar hand dynamometer|The Jamar hand dynamometer is a screening instrument that is used to assess grip strength.
16158887|NCT01711580|Other|EORTC QLQ- FA13|The Fatigue Questionnaire (QLQ-FA13) is a 13-item questionnaire to assess fatigue in patients with cancer. It is meant to be used in conjunction with the EORTC QLQ-C30
16158888|NCT01711580|Other|Trail Making Test (TMT)|The TMT The Trail Making Test is a neuropsychological test of visual attention and task switching. It consists of two parts in which the subject is instructed to connect a set of 25 dots as fast as possible while still maintaining accuracy.
16158889|NCT01711567|Drug|tenofovir|tenofovir 300 mg qd
16158890|NCT01711567|Drug|entecavir|entecavir 0.5 mg qd
16158891|NCT01711554|Biological|Dinutuximab|Given IV
16158892|NCT01711554|Drug|Isotretinoin|Given PO
16158893|NCT01711554|Other|Laboratory Biomarker Analysis|Correlative studies
16158894|NCT01711554|Drug|Lenalidomide|Given PO
16158895|NCT01711554|Other|Pharmacological Study|Correlative studies
16158896|NCT01711541|Drug|Carboplatin|Given IV
16158897|NCT01711541|Drug|Cisplatin|Given IV
16158898|NCT01711541|Drug|Fluorouracil|Given IV
16158899|NCT01711541|Drug|Hydroxyurea|Given PO
16158900|NCT01711541|Other|Laboratory Biomarker Analysis|Correlative studies
16158901|NCT01711541|Drug|Paclitaxel|Given IV
16158902|NCT01711541|Other|Placebo Administration|Given PO
16158903|NCT01711541|Radiation|Radiation Therapy|Undergo radiation therapy
16158904|NCT01711541|Drug|Veliparib|Given PO
16158905|NCT01711528|Drug|Bortezomib|Given SC
16158906|NCT01711528|Drug|Dexamethasone|Given PO
16158907|NCT01711528|Drug|Dinaciclib|Given IV
16158908|NCT01711528|Other|Laboratory Biomarker Analysis|Correlative studies
16158909|NCT01711515|Drug|Cisplatin|Given IV
16158910|NCT01711515|Radiation|External Beam Radiation Therapy|Undergo external beam radiation therapy
16158911|NCT01711515|Radiation|Internal Radiation Therapy|Undergo intracavitary brachytherapy
16158912|NCT01711515|Biological|Ipilimumab|Given IV
16158913|NCT01711515|Other|Laboratory Biomarker Analysis|Correlative studies
16158914|NCT01711489|Drug|isavuconazole|oral
16158915|NCT01711489|Drug|Mycophenolate mofetil|oral
16158916|NCT01711476|Behavioral|Placebo Comparator: Lifestyle counseling Dinner Diet ARM 2|In this Arm 2 group the PCOS will be assigned to dinner diet and we will compare the androgen levels Day 0 to androgen after DAY 90 of this diet also we will compare Glucose and Insulin response to OGTT Day 0 and Day 90, and ovulatory frequency along alll the 90 days of the Dinner diet
16158920|NCT01711450|Procedure|Paravertebral block|Injection of local anaesthesia into paravertebral space to provide analgesia
16159395|NCT01708109|Other|no measures taken to clear bile ductus|biliary calculus remain
16158921|NCT01711450|Procedure|Control sham procedure|Injection of Normal saline into the paravertebral space
16158922|NCT01711437|Device|PEG-4000 with citrates and simethicone|1-4 bisacodyl 5-mg tablets (Lovoldyl) at 16:00, followed 2-3 hours later by 50 ml/kg (maximum 2 L) of PEG-CS solution. The patients were instructed to drink all solution in about 2-3 hours.
16158923|NCT01711437|Device|polyethylene glycol 4000 solution with simethicon|patients received a polyethylene glycol 4000 solution with simethicon (Selg Esse) starting at 3:00 p.m. the day before the colonoscopy at a dose of 100 ml/Kg (maximum 4 L). The patients were instructed to drink all solution in about 4-6 hours.
16158924|NCT01711437|Device|polyethylene glycol 3350 hyper-osmotic solution with ascorbic acid|patients received a polyethylene glycol 3350 hyper-osmotic solution with ascorbic acid (Moviprep) a dose of 50 ml/Kg (maximum 2 L) with 25 ml/kg additional clear fluid after completing solution intake.
16158925|NCT01711437|Device|sodium picosulphate plus magnesium oxide and citric acid|patients received two sachets of sodium picosulphate plus magnesium oxide and citric acid (Picoprep), each diluted in 150 ml of water, at 14:00 and 6 hours later in the evening prior to the colonoscopy. Intake of at least 40-50 ml/kg of clear fluids
16158926|NCT01711424|Drug|OPTIVE PLUS®|Patients with dry eye prescribed OPTIVE PLUS® in accordance with physician standard practice.
16158927|NCT01711411|Device|PrePex device for male circumcision|PrePex is a sterile device for adult male circumcision, consisting of an inner ring, elastic ring, placement ring, and verification thread. Proper sizing is facilitated by a sizing accessory. The elastic ring is loaded on to the placement ring, which is then placed at the base of the penis. The inner ring is placed inside the foreskin. The elastic ring is then deployed around the foreskin, clamping the foreskin against the inner ring. PrePex is manufactured by Circ MedTech Limited, is certified CE - Class IIa in the European Union, and has been approved by the U.S. Food and Drug Administration.
16158928|NCT01711398|Drug|Drug|
16158929|NCT01711385|Behavioral|Enhanced intervention|Study patients are notified of their blood test result within 72 hours. Those identified as potentially pre-diabetic or diabetic, and randomized to the enhanced intervention arm, receive a tailored message about their modifiable risks and are advised to see their physician regarding their test results or are provided with a referral to one. They are given a letter to take to their physician that specifies the risk factors identified, the tests carried out for the patient and the exact numeric results. They receive a call at month 2 to see if they have followed up with a physician regarding their test results. If they have not seen a physician regarding their results, they are advised again to do so and reminded of their individual risk factors. At month 4 they are asked again if they have seen a physician regarding their test results. If they still have not seen a physician at this time the message is reinforced. They are contacted again by phone to schedule the 6-month recall visit.
16158930|NCT01711372|Device|Groundskeeper game for controls|The Groundskeeper game is a go/no go task that captures reaction time and movement using the accelerometers and touch capabilities of the Sifteo cubes.
16158931|NCT01711372|Device|Groundskeeper game for ADHD|The Groundskeeper game is a go/no go task that captures reaction time and movement using the accelerometers and touch capabilities of the Sifteo cubes.
16158932|NCT01711359|Drug|Baricitinib|Administered orally
16158933|NCT01711359|Drug|Methotrexate|Administered orally
16158934|NCT01711359|Drug|Baricitinib Placebo|Baricitinib placebo administered orally once daily.
16158935|NCT01711359|Drug|MTX Placebo|MTX placebo administered orally once weekly.
16158936|NCT01711359|Drug|Folic Acid|Administered orally every day
16158937|NCT01711346|Biological|S303 Red Blood Cells (RBCs)|Each subject will receive one intravenous infusion of autologous radiolabeled S303 Red Blood Cells (RBCs) in random order. Each infusion will be approximately 10 to 30 mL.
16158938|NCT01711346|Biological|Conventional, untreated Red Blood Cells (RBCs)|Each subject will receive one intravenous infusion of autologous radiolabeled Conventional, untreated Red Blood Cells (RBCs) in random order. Each infusion will be approximately 10 to 30 mL.
16158939|NCT01711333|Drug|Pletaal SR capsule|two capsules once a day of Pletaal SR 100mg Capsules
16158940|NCT01711320|Drug|Placebo|
16158941|NCT01711320|Drug|Omeprazole|
16158942|NCT01711307|Procedure|operative|
16158943|NCT01711307|Procedure|non-operative|casting within 48 hrs
16158944|NCT01711294|Device|19 G Flex Needle|Fine Needle Aspiration of PCL with a 19 G Flex needle. If unsuccessful, a salvage procedure will be done with 19 G or 22 G needle.
16158945|NCT01711294|Device|22 G Needle|Fine Needle Aspiration of PCL with a 22 G needle. If unsuccessful, a salvage procedure will be done with 19 G Flex needle.
16158946|NCT01711294|Device|19 G Needle|Fine Needle Aspiration of PCL with a 19 G needle. If unsuccessful, a salvage procedure will be done with 19 G Flex needle.
16158947|NCT01711281|Device|Intracardiac Impedance Measurement Algorithm (integrated in CRT-D device)|
16158948|NCT01711242|Drug|Capecitabine|
16158949|NCT01711242|Drug|Oxaliplatin|
16158950|NCT01711242|Radiation|Radiotherapy|
16158951|NCT01711229|Drug|IV acetaminophen|Ofirmev will be given 15 minutes prior to going to the OR
16158952|NCT01711229|Drug|oral acetaminophen|oral acetaminophen will be given preoperatively
16158953|NCT01711203|Other|Motor Control|Exercises and verbal cues to facilitate deep abdominal control and contraction for muscular stabilization/re-training.
16158954|NCT01711203|Other|General Strengthening|General abdominal and lower quarter musculature strengthening
16158955|NCT01711190|Procedure|trabeculectomy|Filtering surgery to reduce the intra-ocular pressure.
16158956|NCT01711177|Drug|placebo|Placebo
16158957|NCT01711177|Drug|travoprost|Travatan Z is administered to newly diagnosed glaucoma patient
16158958|NCT01711125|Drug|Baclofen 30mg/day|30mg/day 10 mg t.i.d
16158959|NCT01711125|Drug|Baclofen 75mg/day|75mg/day 25 mg t.i.d
16158960|NCT01711125|Drug|Placebo|Placebo 3 matched tabs/day
16158961|NCT01711112|Drug|Docetaxel|Treatment will be continued until progression, unacceptable toxicity, or refusal
16158962|NCT01711099|Device|device for Extracorporeal Shockwave Myocardial Revascularization (ESMR) therapy|
16158963|NCT01711086|Device|Aerolizer Followed by Inspiromatic|Participants will receive Formoterol (Foradil) 12mcg via the Foradil Aerolizer inhaler while performing lung function as part of the and not differ from other routine follow-up
16159012|NCT01710709|Drug|Aripiprazole|400mg or 300mg, intramuscular injections every 4 weeks.
16158964|NCT01711086|Device|Inspiromatic followed by Aerolizer|Participants will receive Formoterol (Foradil) 12mcg via the Inspiromatic dry powder inhaler while performing lung function instead of getting it via the Foradil Aerolizer
16158965|NCT01711073|Drug|Mobilization with G-CSF and Mozobil|Treatment with drugs for mobilization of MSCs
16158966|NCT01711060|Drug|oxytocin|
16158967|NCT01711060|Procedure|balloon catheter|
16158968|NCT01711047|Procedure|Radiofrequency catheter Ablation|In this arm, catheter ablation would be performed in the left atrium and would include pulmonary vein isolation and linear ablations (roof and mitral isthmus lines)
16158969|NCT01711047|Procedure|Radiofrequency catheter ablation|In this arm, catheter ablation would be performed in the left atrium, including pulmonary vein isolation, linear ablations (roof and mitral isthmus lines) and Complex Fractionated Atrial Electrograms (CFAE) ablation.
16158970|NCT01711034|Drug|OPB-111077|"Dose escalation phase starting with dose of 100mg tablets on Day 1 and 4, and all remaining days of each 28 day cycle until disease progression or toxicity develops.
~Dose expansion phase starting with daily dosing of 250mg for 28 day consecutive day cycles."
16158971|NCT01711021|Drug|d-Amphetamine Transdermal System|Patches will be worn for 9 hours every day. After 9 hours the patch will be removed. Every day a new patch will be applied.
16158972|NCT01711021|Drug|Placebo patch|Patches will be worn for 9 hours every day. After 9 hours the patch will be removed. Every day a new patch will be applied.
16158973|NCT01711008|Dietary Supplement|Cereal|
16158974|NCT01711008|Dietary Supplement|No breakfast|
16158975|NCT01710995|Drug|Zegerid|
16158976|NCT01710995|Drug|Losec|
16158977|NCT01710982|Drug|TZP-101|
16158978|NCT01710982|Other|Placebo|
16158979|NCT01710969|Behavioral|Individual intervention|34 weekly sessions of cognitive-behavioral Coping Power intervention, delivered in an individual one-to-one format
16158980|NCT01710969|Behavioral|Group Intervention|34 weekly sessions of Coping Power intervention, delivered in a small group format (6 children per gorup)
16158981|NCT01710956|Radiation|Arm 1: with twice-daily thoracic radiotherapy/ Arm 2: with once-daily thoracic radiotherapy|Arm 1: with twice-daily thoracic radiotherapy daily 1.5gy/fr. bid, total 45gy(30fr during 3weeks) Arm 2: with once-daily thoracic radiotherapy daily 2.4gy/fr. qd, total 60gy(25fr during 5weeks)
16158982|NCT01710943|Behavioral|Web-based Cognitive Behavioral Treatment|"Participants in this condition will be asked to complete 24 CBT sessions, 2 sessions/topics per week for 12 weeks. We expect that each session will be approximately 30 minutes in duration. Participants will be asked to complete the 18 core modules of the program during the first 9 weeks of the trial and then to re-visit important modules and complete optional modules of their choice during the final 3 weeks of the trial. They can choose to do this using a designated computer in a private room at their local VA or can complete these sessions in the privacy of their own home with their personally-owned computers. Participants can choose to complete each session on any day/time of their choosing in a given week."
16158983|NCT01710930|Other|Study of predictive factors|"Phase 1 : Inclusion of patients (V0) :
~In the case of a participation agreement, data on age, profession, previous history, history of the disease and current treatments will be collected. Different tests will be performed at this visit.
~Phase 2 : Determination of the baseline (V1) : Patients will be reviewed one month after V0 (V1). In the absence of exacerbation between V0 and V1, the examinations performed in routine practice will be used to determine the basic state of biological parameters of interest. During this visit, different tests will be performed.
~Phase 3 : Quarterly monitoring of patients (V2-V9) : Patients will be followed every three months for 2 years (V2-V9)."
16158984|NCT01710917|Drug|Targinact® (oxycodon/naloxon)|
16158985|NCT01710904|Drug|Targinact® (oxycodone/naloxone)|
16158986|NCT01710891|Procedure|CMAC videolaryngoscope|patients are intubated using the CMAC video laryngoscope
16158987|NCT01710891|Procedure|Direct Laryngoscopy|Patients undergo their first intubation attempt using direct laryngoscopy with a C-MAC device with the video display covered with a hood.
16158988|NCT01710878|Device|Intergard Synergy Graft|
16158989|NCT01710865|Other|Ultraseal Sealant|This is a newly developed hydrophilic sealant material.
16158990|NCT01710865|Other|Ultraseal Sealant|This is a previously existing hydrophobic sealant material.
16158991|NCT01710852|Drug|ISIS CRP Rx|
16158992|NCT01710852|Drug|Placebo|
16158993|NCT01710839|Drug|0.5mg Ranibizumab|intravitreal injections
16158994|NCT01710839|Procedure|Targeted Pan Retinal Photocoagulation|Targeted Pan Retinal Photocoagulation based on wide field angiography
16158995|NCT01710826|Biological|Genz-682452|Capsules for oral administration.
16158996|NCT01710826|Biological|Placebo|Placebo capsules matching the Genz-682452 capsules.
16158997|NCT01710813|Biological|alglucosidase alfa|Alglucosidase alfa IV infusion of 20 mg/kg; qow
16158998|NCT01710800|Drug|Esomeprazole|
16158999|NCT01710800|Drug|placebo|
16159000|NCT01710787|Drug|Tetracaine HCl 3% and Oxymetazoline HCl 0.05%|3 unilateral intranasal sprays per dose
16159001|NCT01710787|Drug|Tetracaine HCl 3%|3 unilateral intranasal sprays per dose
16159002|NCT01710787|Drug|Placebo|3 unilateral intranasal sprays per dose
16159003|NCT01710774|Procedure|Telemedicine follow-up care|Telemedicine follow-up care for people with diabetes-related foot ulcers in municipal primary health care in collaboration with specialist health care
16159004|NCT01710761|Dietary Supplement|Placebo|Same form factor and flavor as test lozenge but contains no active ingredients
16159005|NCT01710761|Dietary Supplement|Nitrate supplement with caffeine|Lozenge consisting of beetroot and 75 mg caffeine
16159006|NCT01710748|Device|Polymer-Based Everolimus-Eluting Stent|Polymer-Based Everolimus-Eluting Stent
16159007|NCT01710748|Device|Polymer-Free Amphilimus-Eluting Stent|Reservoir-Based Polymer-Free Amphilimus-Eluting Stent
16159008|NCT01710735|Procedure|Dry needling|Insertion of acupuncture needle into a myofascial trigger point.
16159009|NCT01710722|Drug|caffeine and ephedrine|Caffeine 200 mg tablets and ephedrine HCl 25 mg tablets three times a day with placebo leptin A-200 subcutaneously once daily.
16159010|NCT01710722|Drug|Leptin A|Leptin A-200 20 mg subcutaneously once daily and placebo tablets of caffeine and ephedrine three times a day.
16159011|NCT01710722|Drug|caffeine, ephedrine, and leptin A|Caffeine 200 mg tablets and ephedrine HCl tablets 25 mg three times a day with leptin A-200 20 mg subcutaneously once daily.
16159013|NCT01710696|Drug|17-beta estradiol|5-15 mcg/kg daily for 2 years. Dose readjusted every 3 months. Administered orally
16159014|NCT01710696|Drug|17-beta estradiol|0.2 mcg daily for 12 months, dose escalated to 0.5 mcg daily for 12 months. Administered orally
16159015|NCT01710683|Behavioral|Care program|Care program with multimodal pain treatment including epidural steroid
16159016|NCT01710683|Behavioral|Care program|Care program with multimodal pain treatment including epidural steroid.
16159017|NCT01710670|Drug|Brivaracetam|"Strength: 200 mg (4 x 50 mg)
~Form: oral tablet
~Frequency: single dose
~Description: All subjects will receive a single oral dose of Brivaracetam (BRV) 200 mg, given as 50 mg tablets times 4 followed by an adequate volume of water (approximately 200 ml) in 2 of the 3 crossover periods. This dose will be administered 30 minutes after the initiation of the Ethanol / Ethanol Placebo infusion on Day 1."
16159018|NCT01710670|Other|Ethanol|"Form: intravenous infusion
~Frequency: continuous infusion
~Description: The ethanol infusion rate is initially based on weight, height, age, and sex. Subsequently, the infusion rate will be adjusted based on Breath Ethanol Measurements to maintain Breath Ethanol Levels (and by extension, blood ethanol levels) of 0.6 g / L."
16159019|NCT01710670|Other|Brivaracetam Placebo|In 1 of the 3 crossover periods, all subjects will receive 4 Placebo tablets to match the 50 mg Brivaracetam (BRV) tablets. The Placebo tablet will contain the same excipients as the BRV tablets but without BRV.
16159020|NCT01710670|Other|Ethanol Placebo|In 1 crossover period subjects will receive Ethanol Placebo (5% glucose). On Day 1, the continuous infusion of Ethanol Placebo will begin with a 30 minute Loading Phase prior to administration of Brivaracetam (BRV) / BRV Placebo and will continue until 5 hours after administration of BRV/BRV Placebo. During the first 10 minutes, the infusion will be accompanied by an infusion of 5% Glucose via the same line in order to mask the sensation at the beginning of the Ethanol infusion.
16159021|NCT01710657|Drug|Lacosamide 50 mg|"Active Substance: Lacosamide
~Pharmaceutical Form: Film-coated tablet
~Concentration: 50 mg
~Route of Administration: Oral use"
16159022|NCT01710657|Drug|Lacosamide 100 mg|"Active Substance: Lacosamide
~Pharmaceutical Form: Film-coated tablet
~Concentration: 100 mg
~Route of Administration: Oral use"
16159023|NCT01710657|Drug|Placebo|Matching oral Placebo tablets twice daily for 16 weeks.
16159024|NCT01710644|Drug|Burlulipase|Burlulipase oral solution will be taken with meals and snacks for 5 to 7 days
16159025|NCT01710644|Drug|Placebo (Caramel in sterile water)|Placebo will be taken with meals and snacks for 5 to 7 days
16159026|NCT01710631|Drug|eszopiclone 3 mg|eszopiclone 3 mg (comprised of either two 1.5 mg tablets, or one 1 mg tablet and one 2 mg tablet).
16159027|NCT01710631|Drug|placebo|placebo
16159028|NCT01710605|Biological|Circulating tumor cells counting at baseline|20 ml blood sample collected before randomization
16159029|NCT01710592|Drug|Epirubicin|
16159030|NCT01710592|Drug|Oxaliplatin|
16159031|NCT01710592|Drug|Capecitabine|
16159032|NCT01710592|Drug|Docetaxel|
16159033|NCT01710579|Procedure|Anorectal 3D-high resolution manometry|Anorectal probe is used with a single-use protective sheath with an inflation balloon Control of balloon deflation Patient in left lateral decubitus position with hips flexed to 90° (this position is the most commonly use and the most convenient) Transanal insertion 2 minutes resting period: resting anal pressure will be evaluated the second minute of rest Sustained voluntary maximal squeeze for at least 30 seconds; the maneuver will be repeated once Valsalva Bear down maneuver; the maneuver will be repeated once Anorectal reflexes evaluation with 20-, 40- and 60-ml intra-rectal balloon inflation Probe removal
16159034|NCT01710579|Procedure|Anorectal radial endosonography (rotative 360° probe)|Patient in left lateral decubitus position with hips flexed to 90° Transanal probe insertion Evaluation of internal and external anal sphincter integrity and puborectalis muscle at rest
16159035|NCT01710579|Procedure|Dynamic anorectal endosonography (sagittal and radial)|Patient in left lateral decubitus position with hips flexed to 90° Rectum is filled with 50-ml water Probe is covered with a water-filled balloon to maintain the acoustic window for the ultrasound wave Transanal probe insertion Slow and manual rotation of the linear probe through 360° to identify the various layers constituting the anal wall (mucosa, IAS, EAS), the layer forming the rectal wall and the perirectal tissues (puborectalis muscle, bladder, and vagina or prostate) After the initial examination, the patient will be asked to make a defecation effort with the probe left in the same position
16159036|NCT01710566|Drug|Misoprostol|600 mcg oral misoprostol to be administered after delivery of baby and before placenta is expelled
16159037|NCT01710566|Drug|Oxytocin|10 IU oxytocin in Uniject will be administered after delivery of baby and before placenta is expelled
16159038|NCT01710553|Other|Glucophage 1000mg|EVALUATE BIOEQUIVALENCE BETWEEN METFORMIN 1000 MG TABLETS MANUFACTURED BY SAVIPHARM J.S.C, VIETNAM AND GLUCOPHAGE® 1000 MG TABLETS MANUFACTURED BY MERCK SANTE S.A.S.2, RUE DU PRESSOIR VERT-45400 SEMOY-FRANCE AND BE REGISTERED IN VIETNAM IN HEALTHY, ADULT, HUMAN MALE SUBJECTS UNDER FASTING CONDITION
16159039|NCT01710553|Other|Metformin GSK 1000mg|EVALUATE BIOEQUIVALENCE BETWEEN METFORMIN 1000 MG TABLETS MANUFACTURED BY SAVIPHARM J.S.C, VIETNAM AND GLUCOPHAGE® 1000 MG TABLETS MANUFACTURED BY MERCK SANTE S.A.S.2, RUE DU PRESSOIR VERT-45400 SEMOY-FRANCE AND BE REGISTERED IN VIETNAM IN HEALTHY, ADULT, HUMAN MALE SUBJECTS UNDER FASTING CONDITION
16159040|NCT01710540|Other|Metformin GSK 850mg|EVALUATE BIOEQUIVALENCE BETWEEN METFORMIN 850 MG TABLETS MANUFACTURED BY SAVIPHARM J.S.C, VIETNAM AND GLUCOPHAGE® 850 MG TABLETS MANUFACTURED BY MERCK SANTE S.A.S.2, RUE DU PRESSOIR VERT-45400 SEMOY-FRANCE AND BE REGISTERED IN VIETNAM IN HEALTHY, ADULT, HUMAN MALE SUBJECTS UNDER FASTING CONDITION
16159041|NCT01710540|Other|Gluocophage 850mg|EVALUATE BIOEQUIVALENCE BETWEEN METFORMIN 850 MG TABLETS MANUFACTURED BY SAVIPHARM J.S.C, VIETNAM AND GLUCOPHAGE® 850 MG TABLETS MANUFACTURED BY MERCK SANTE S.A.S.2, RUE DU PRESSOIR VERT-45400 SEMOY-FRANCE AND BE REGISTERED IN VIETNAM IN HEALTHY, ADULT, HUMAN MALE SUBJECTS UNDER FASTING CONDITION
16159042|NCT01710527|Drug|Metformin 500mg|EVALUATE BIOEQUIVALENCE BETWEEN METFORMIN 500 MG TABLETS MANUFACTURED BY SAVIPHARM J.S.C, VIETNAM AND GLUCOPHAGE® 500 MG TABLETS MANUFACTURED BY MERCK SANTE S.A.S.2, RUE DU PRESSOIR VERT-45400 SEMOY-FRANCE AND BE REGISTERED IN VIETNAM IN HEALTHY, ADULT, HUMAN MALE SUBJECTS UNDER FASTING CONDITION
16159043|NCT01710527|Drug|Glucophage 500mg|EVALUATE BIOEQUIVALENCE BETWEEN METFORMIN 500 MG TABLETS MANUFACTURED BY SAVIPHARM J.S.C, VIETNAM AND GLUCOPHAGE® 500 MG TABLETS MANUFACTURED BY MERCK SANTE S.A.S.2, RUE DU PRESSOIR VERT-45400 SEMOY-FRANCE AND BE REGISTERED IN VIETNAM IN HEALTHY, ADULT, HUMAN MALE SUBJECTS UNDER FASTING CONDITION
16159046|NCT01710501|Biological|pegylated interferon alfa-2b|1.5 mcg/kg/week, administered as a weekly subcutaneous (SC) injection
16159047|NCT01710501|Drug|Ribavirin|Ribavirin capsule, orally, twice daily, at a dose of 800 to 1400 mg based on participant weight
16159048|NCT01710501|Drug|Placebo|Placebo to match grazoprevir tablets to maintain dose blinding
16159049|NCT01710488|Drug|Levofloxacin 1 tablet 500 mg once a day|"Will be used, according to a randomization list pre-ordered, centralized, in blocks of 4 patients:
~Levofloxacin 500 mg (1 tablet) once daily for 7-10 days. The prescribing and dispensing of the drug will be made by medical personnel not directly involved in the data collection procedures for the study, and nursing staff, and the Medical Investigator will not be aware of the type of treatment to the individual. The drugs will be administered in the morning, about two hours after food."
16159050|NCT01710488|Drug|Prulifloxacin 1 tablet 600 mg once a day|"Will be used, according to a randomization list pre-ordered, centralized, in blocks of 4 patients:
~Prulifloxacin 1 tablet 600 mg once daily for 7-10 days. The prescribing and dispensing of the drug will be made by medical personnel not directly involved in the data collection procedures for the study, and nursing staff, and the Medical Investigator will not be aware of the type of treatment to the individual. The drugs will be administered in the morning, about two hours after food."
16159051|NCT01710462|Drug|Pantoprazole + Domperidone|
16159052|NCT01710462|Drug|Pantozol®|
16159053|NCT01710449|Drug|perfluorinated gas/oxygen mixture|Subjects are imaged with MRI one time in an proof of concept study for the use of perfluorinated gas / oxygen mixtures as an MRI contrast agent for lung function.
16159054|NCT01710423|Behavioral|Peer mentoring intervention ('Cooking with Friends')|"'Cooking with Friends' is a community-located, peer mentoring intervention aimed at improving home food preparation practices in families with young children.
~The intervention was developed in an iterative, community-based research approach, and will be conducted in partnership with Early Head Start (EHS) at The Children's Hospital of Philadelphia. Cooking with Friends builds on existing monthly cooking classes at EHS that have proven popular with EHS families. Through 5 weekly classes, this intervention will explore topics of how to prepare healthy foods at home.
~The peer mentoring component is a novel innovation to this intervention. The intervention pairs peer mentors to individual mentees in a community setting, to effect behavioral change among caregivers of young children."
16159055|NCT01710410|Device|active transcranial Direct Current Stimulation|Brief (20-min) application of weak electric current (e.g., 2 mA) to the scalp.
16159056|NCT01710410|Device|sham transcranial Direct Current Stimulation|Brief (30-sec) application of weak electric current (e.g., 2mA) to the scalp.
16159057|NCT01710397|Other|Rapid ART initiation|Subjects offered the intervention who are eligible for antiretroviral therapy under South African guidelines will be offered the opportunity to initiate ART immediately, if possible on the same day as testing positive for HIV. Rapid testing technologies and an accelerated schedule will be used to allow all steps required prior to initiating ART to take place in approximately a half-day period.
16159058|NCT01710384|Drug|betamethasone|
16159059|NCT01710371|Drug|18F-AV-133|296 MBq (8 mCi)
16159060|NCT01710371|Drug|10% Arginine Hydrochloride-R-Gene 10|
16159061|NCT01710358|Drug|Adalimumab|Administered SC
16159062|NCT01710358|Drug|Baricitinib|Administered orally
16159063|NCT01710358|Drug|Methotrexate|Administered orally
16159064|NCT01710358|Drug|Adalimumab Placebo|Adalimumab placebo administered SC.
16159065|NCT01710358|Drug|Baricitinib Placebo|Baricitinib placebo administered orally.
16159066|NCT01710345|Drug|Sufentanil NanoTab 20 mcg|
16159067|NCT01710345|Drug|Sufentanil NanoTab 30 mcg|
16159068|NCT01710345|Drug|Placebo NanoTab|
16159069|NCT01710332|Drug|Intravitreal Aflibercept Injection|"GROUP A - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, and Month 4 (four injections total).
~GROUP B - Aflibercept 2 mg injected at Baseline, Month 1, Month 2, Month 3, Month 4, and Month 5 (six injections total)."
16159070|NCT01710319|Other|blood draw|a blood specimen will be obtained from each patient in the four groups. An optional blood draw after 30 days of initial blood specimen if indicated.
16159071|NCT01710306|Behavioral|Nurse Care Manager (NCM)|Nurse care manager interventions with telephone implemented shared decision making protocol compared to outreach as usual OEF/OIF/OND outreach.
16159072|NCT01710293|Behavioral|Communication of Patients Lost to Follow-up to Providers|"The investigators will query the VA's database weekly to identify possible lost to follow-up events for a random sample of about half of the providers at our study sites. The queries will use the trigger criteria developed in our previous work for colorectal cancer, lung cancer, hepatocellular carcinoma, breast cancer, and bladder cancer. The list of trigger positive patients will be transmitted to a facility-level recipient who will either disseminate the information to existing facility individual cancer care coordinators/trackers or will review the charts of the triggered patients in order to determine whether these patients have been truly lost to follow-up or not. If patients are found to be lost to follow-up, the Facility Recipient or cancer care coordinator/tracker will communicate the need for follow-up to the PACT or primary care provider, using secure emails, phone calls, or in person, depending on which method of communication they deem most appropriate and effective."
16159073|NCT01710280|Dietary Supplement|High-fat meal containing native palm olein|
16159074|NCT01710280|Dietary Supplement|High-fat meal containing interesterified palm olein|
16159075|NCT01710254|Drug|Regadenoson MRI|AF patients will be provided with a regadenoson stress MRI to see if coronary artery disease can be detected with more sensitivity /specificity.
16159076|NCT01710254|Drug|Gadobenate dimeglumine|Resting perfusion with Multihance Gd-BOPTA contrast agent will be performed first, then a regadenoson injection will be given and MR imaging performed with a Gd-BOPTA contrast agent bolus 60-100 seconds later.
16159077|NCT01710228|Drug|methylprednisolone|192 MG FOR 5 CONSECUTIVE DAYS EVERY 4 WEEKS FOR 10 MONTHS
16159078|NCT01710215|Other|FIT Screening Strategy|"Mailed outreach invitation to complete FIT, including a test kit (1-sample FIT, simplified instructions on how to perform the test, and return mailer with prepaid postage).
~Two live phone reminders from project staff 2 to 3 weeks after the invitation to encourage screening completion.
~Centralized processes to promote guideline-based follow up."
16159130|NCT01709877|Procedure|Cholecystectomy|Multiport and single-port laparoscopic cholecystectomy in patient with symptomatic gallstone disease
16159131|NCT01709864|Drug|NVA237|NVA237 (glycopyrronium bromide) as a powder for inhalation in single-dose capsules.
16159079|NCT01710215|Other|Colon Screening Strategy|"Mailed outreach invitation to complete a colonoscopy, including a number to call to schedule a colonoscopy.
~Two live phone call reminders from project staff 2 to 3 weeks after the mailed invitation to encourage screening completion.
~Centralized processes to promote guideline-based follow up."
16159080|NCT01710202|Drug|Hydrocortisone|Each subject in this group will receive one 20mg hydrocortisone capsule to be taken by mouth.
16159081|NCT01710189|Drug|TicoVac|Intramuscular immunisation to right deltoid muscle (Group 1) or right upper anterolateral thigh muscle (Group 2).
16159082|NCT01710176|Drug|epirubicin 60 mg/m2/day (days 1, 2) and ifosfamide 3 g/m2/day (days 1, 2, 3)|
16159083|NCT01710176|Drug|gemcitabine 900 mg/m2 (days 1 and 8) and docetaxel 75 mg/m2 (day 8)|
16159084|NCT01710176|Drug|trabectedin 1.3 mg/m2|
16159085|NCT01710176|Drug|high-dose ifosfamide 14 g/m2, given in in 14 days|
16159086|NCT01710176|Drug|etoposide 150 mg/m2/day (days 1, 2, 3) and ifosfamide 3g/m2/day (days 1, 2, 3)|
16159087|NCT01710176|Drug|gemcitabine 1800 mg/m2 (day 1) and dacarbazine 500 mg/m2 (day 1)|
16159088|NCT01710163|Drug|Lithium|Starting at 300 mg daily, weekly dose will be adjusted according to blood serum level (between 0.5 -0.8mEq/l) according to efficacy and tolerability.
16159089|NCT01710163|Drug|Aripiprazole|Starting at 10 mg daily, dose will be adjusted up to 15 mg daily according to efficacy and tolerability.
16159090|NCT01710150|Procedure|CTI ablation alone|
16159091|NCT01710150|Procedure|CTI ablation and Pulmonary vein isolation (PVI)|
16159092|NCT01710137|Drug|Varenicline|
16159093|NCT01710137|Drug|Placebo|
16159094|NCT01710137|Behavioral|Smoking Cessation Counseling|
16159095|NCT01710124|Other|Financial incentives|
16159096|NCT01710111|Device|Intervention Recipients Face Shield|Face shield and repeat hand hygiene measures
16159097|NCT01710098|Drug|Degarelix|subcutaneous injection
16159098|NCT01710085|Device|Diffusion weighted MRI (DW- MRI)- Philips Achieva 3.0T X, Netherlands, 2011|Recurrence in cervical and endometrial cancer patients who were treated with curative surgery is routinely investigated by MRI examination. MRI is diagnostic technique not requiring ionizing radiation and is based on magnetic fields.
16159099|NCT01710072|Drug|aspirin|
16159100|NCT01710059|Behavioral|Asthma Supervision|Each participant will be provided with a spacer and a peak flow meter, and instructions on proper technique, by a member of the study team during the baseline period. They will also meet with study staff at study visits during the active treatment phase to review their adherence to daily inhaled corticosteroids and usage patterns of short acting B2-agonist medication.
16159101|NCT01710059|Behavioral|Mobile Phone|Each participant will receive a mobile phone with talking, texting and a data plan. They will get to keep the mobile phone at the end of the study, but the talking, texting and data plan will only be active during their participation in the study.
16159102|NCT01710059|Behavioral|Inhaled Corticosteroid Mobile Phone Application|The Inhaled Corticosteroid Mobile Phone Application will be used to provide virtual doctor supervision, immediate feedback, and positive reinforcement for taking inhaled corticosteroid medication as indicated.
16159103|NCT01710059|Behavioral|Beta2-adrenergic agonist Mobile Phone Application|The Beta2-adrenergic agonist Mobile Phone Application will be used to track real time patterns of use of beta2-adrenergic agonist medication.
16159104|NCT01710046|Drug|(CP-6890,550) Tofacitinib|2 x 5 mg oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks
16159105|NCT01710046|Drug|Placebo|2 matching oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks
16159106|NCT01710046|Drug|(CP-690,550) Tofacitinib|2 x 5 mg oral capsules taken twice daily (every 12 hours) for 12 weeks
16159107|NCT01710046|Drug|Placebo|2 matching oral capsules taken twice daily (every 12 hours) for 12 consecutive weeks
16159108|NCT01710033|Drug|Placebo|Placebo tables twice daily (BID) for 28 days
16159109|NCT01710033|Drug|CP-690,550 5 mg BID|CP-690,550 5 mg BID for 28 days
16159110|NCT01710033|Drug|CP-690,550 15 mg BID|CP-690,550 15 mg BID for 28 days
16159111|NCT01710033|Drug|CP-690,550 30 mg BID|CP-690,550 30 mg BID for 28 days
16159112|NCT01710020|Drug|CP-690,550|CP-690,550 10 mg oral powder for constitution
16159113|NCT01710007|Drug|1PC002|Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.
16159114|NCT01710007|Drug|Lipitor|Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.
16159115|NCT01709994|Drug|Aspirin|100 mg/day of aspirin
16159116|NCT01709981|Drug|Colchicine|Colchicine 1.2mg 1 to 2 hours prior PCI, followed by 0.6mg 1 hour later
16159117|NCT01709981|Drug|Placebo|Placebo 1 to 2 hours prior PCI, followed by Placebo 1 hour later
16159118|NCT01709968|Drug|MAGNOX 520®|un-organic granular magnesium complex, composed of Magnesium Oxide & Magnesium Oxide Monohydrate 865mg, Provides 520 mg of free elemental Mg ++); Oral administration once daily for 4 weeks
16159119|NCT01709968|Drug|placebo|Similarly looking placebo. Oral administration once daily for 4 weeks
16159120|NCT01709955|Dietary Supplement|Glucomannan|750 MG of Glucomannan in capsule form
16159121|NCT01709955|Other|Placebo|750 mg of Cellulose powder in a capsule form
16159122|NCT01709942|Drug|degarelix (long acting GnRH antagonist)|20 mg of degarelix the first day of menstrual cycle before starting with gonadotrophins administration
16159123|NCT01709942|Drug|cetrorelix 0.25mg|0.25mg of cetrorelix during treatment with gonadotrophins when estradiol levels were >300pg/ml
16159124|NCT01709929|Drug|insulin detemir|Administered subcutaneously (s.c., under the skin). Dose individually adjusted.
16159125|NCT01709903|Drug|QVA149|QVA149 110/50 µg capsules q.d. for inhalation, delivered via Novartis single dose dry powder inhaler (SDDPI).
16159126|NCT01709903|Drug|Fluticasone/salmeterol|Active fluticasone/salmeterol (500/50µg) b.i.d via a dry power inhaler Accuhaler® device.
16159127|NCT01709903|Drug|Placebo to QVA149|Placebo to QVA149 with SDDPI
16159128|NCT01709903|Drug|Placebo to fluticasone/salmeterol|Placebo to fluticasone/salmeterol with Accuhaler
16159129|NCT01709890|Device|YO2(R) catheter|
16159247|NCT01709110|Drug|Risedronate|Administered orally
16159132|NCT01709864|Drug|Placebo|Placebo powder for inhalation in single-dose capsules (matching those for NVA237).
16159133|NCT01709851|Device|Vascular microdialysis using the GMD-system|Glucose levels will be monitored by means of vascular microdialysis using the GlucoMen(R)Day system
16159134|NCT01709851|Device|Vascular and subcutaneous microdialysis using the GMD-system|Glucose levels will be monitored by means of vascular and subcutaneous microdialysis using the GlucoMen(R)Day system
16159135|NCT01709838|Drug|deferasirox|Deferasirox dispersible tablets at strengths of 125 mg, 250 mg, and 500 mg were administered by oral daily dosing.
16159136|NCT01709825|Dietary Supplement|Probiotic- Bifidobacterium Bifidum|Bifidobacterium bifidum R0071 will be taken as a capsule once daily for 6 weeks.
16159137|NCT01709825|Dietary Supplement|Sugar Pill|Sugar Pill (Sucrose) will be taken as a capsule once daily for 6 weeks.
16159138|NCT01709825|Dietary Supplement|Probiotic- Lactobacillus helveticus|Lactobacillus helveticus R0052 will be taken as a capsule once daily for 6 weeks.
16159139|NCT01709825|Dietary Supplement|Probiotic- Bifidobacterium longum ss. Infantis R0033|Bifidobacterium longum ss. Infantis R0033 (Supplement C) will be taken as a capsule once daily for 6 weeks.
16159140|NCT01709812|Other|individualized patient support program|individualized patient support with compliance supporting tools
16159141|NCT01709812|Other|Standard care|
16159142|NCT01709799|Behavioral|Exercise|"Participants will do physical activity that raises heart rate to a target heart rate (THR)zone which is pre-calculated using the Karvonen Formula:
~(THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate
~Participants begin exercise regimen starting at 50% THR for intensity and gradually increase by 5% up to a maximum of 75% THR.
~Activity duration begins at 10 mins./day and increases 5 mins. every week following to a maximum of 40 mins. Polar Heart Rate monitors are used to measure THR and save resulting data."
16159143|NCT01709799|Behavioral|Exergames|"Participants experience Wii Video Games in a standardized format, beginning with 15 mins of seated play per day on week one, and then increasing 5 mins./week on each week following up to a maximum of 40mins. of play.
~Participants are made aware of the Target Heart Rate Zone for the week, but are not required to reach that zone during play. The THR is calculated by the Karvonen Formula:
~THR={(max. heart rate- rest heart rate) x %intensity} + resting heart rate
~Polar Heart Rate monitors are used to measure THR and save resulting data."
16159144|NCT01709799|Behavioral|Cognitive Training|"Posit Science INSIGHT program games are used for all cognitive training. Participants are exposed to (2) forty minute game sessions per day, for the cognitive training weeks #4,8,12,16.
~INSIGHT Assessments are done at baseline, the start of each training week and at week 28."
16159145|NCT01709773|Procedure|Focal treatment|Focal treatment of high-grade cervical intraepithelial neoplasia using laser ablation, cryotherapy, or loop electrosurgical excision procedure
16159146|NCT01709760|Drug|Methotrexate|Methotrexate 15-25 mg/week
16159147|NCT01709760|Drug|ENIA11|ENIA11 25 mg, sc twice weekly
16159148|NCT01709760|Drug|Placebo|Placebo, sc twice weekly
16159149|NCT01709747|Drug|Hydromorphone Hydrochloride|Opioid for chronic pain
16159150|NCT01709747|Device|Programmable Implantable pump|"Device: Programmable Implantable pump
~Programmable Implantable pump delivering intrathecal hydromorphone"
16159151|NCT01709734|Drug|galeterone|
16159152|NCT01709721|Drug|Hydromorphone Hydrochloride|Opioid for chronic pain
16159153|NCT01709721|Device|Programmable Implantable pump|Programmable Implantable pump delivering intrathecal hydromorphone
16159154|NCT01709708|Drug|Marcaine|Marcaine used as a topical local anesthetic to block the SPG by delivering Marcaine directly to the specific area of mucosa associated with the SPG.
16159155|NCT01709708|Drug|Saline|Saline
16159156|NCT01709695|Drug|Guanfacine Hydrochloride XR|Weekly adjustments based on parent ratings of symptoms, side effects, and health status per vital signs up to 4mg maximum dose
16159157|NCT01709695|Drug|Placebo|Weekly adjustments based on parent ratings of symptoms, side effects, and health status per vital signs up to 4mg maximum dose
16159158|NCT01709682|Drug|Anti-Arrhythmia Agents (propafenone, flecainide, and/or sotalol, or amiodarone)|propafenone, flecainide, and/or sotalol as first-line drugs in patients without structural heart disease or amiodarone as a single drug or in combination in patients with structural heart disease or in case of first-line drug failure
16159159|NCT01709682|Procedure|re-ablation procedure|Reisolation of the PVs was performed by identifying the breakthrough site on the mapping catheter (NaviStar ThermoCool, Biosense-Webster Inc., Diamond Bar, CA). RF energy was delivered at 43°C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and was reduced to 43°C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation rate of 17 mL/min. Each lesion was ablated continuously until the local potential amplitude decreased by >80% or RF energy deliveries exceeded 40 s. The endpoint of ablation was complete PVI; this was confirmed when Lasso catheter mapping showed the disappearance of all PV potentials or the dissociation of PV potentials from LA activity.
16159160|NCT01709682|Procedure|ILR implantation|"The Reveal XT was implanted in the parasternal area of the chest. The requirement for defining the exact final position was an R-wave amplitude ≥0.4 mV assessed through the Vector Check.
~Patients were provided with the Patient Assistant, a tool that allows each patient to store the ECG through the implanted device during symptoms; data were collected in order to analyze heart rhythm during symptomatic events."
16159161|NCT01709656|Biological|MSC|"human mesenchymal stem cells,1*10^4-6 cells /Kg , IV (in the vein) on day 1 of each 14-60 day cycle,1-6 times treatment.
~a total of 24 weeks for follow up."
16159162|NCT01709656|Drug|"celecoxib, Celebrex®"|"non-steroid anti-inflammatory drugs (NSAID):celecoxib, Celebrex® 0.2g Bid(twice a day),PO (Per Os);a total of 24 weeks for follow up"
16159163|NCT01709643|Dietary Supplement|High fat breakfast|"The HF breakfast will consist of sausage rolls (saucijzenbroodjes), available at the local Albert Heijn (Albert Heijn B.V., Zaandam, The Netherlands)."
16159164|NCT01709643|Dietary Supplement|HF breakfast with protein|For the HFP breakfast, the subjects will consume 'Protifar' (Nutricia, Cuijk, The Netherlands) in addition to the sausage rolls.
16159165|NCT01709630|Drug|Magnesium sulfate infusion|Participants will be given magnesium sulfate infusion as part of their normal care for either preeclampsia, tocolysis, or neuroprotection.
16159166|NCT01709617|Dietary Supplement|Carbohydrate ingestion|Various types of carbohydrate ingested during and following exercise
16159167|NCT01709604|Procedure|CVVH|Ultrafiltration at 35ml/h/Kg
16171627|NCT01611363|Drug|Placebo|Oral
16159168|NCT01709604|Procedure|Standardized therapy regimens|"Standardized therapy regimens included the followings:
~Remove all contaminated clothing
~Gastric lavage
~Receive activated charcoal as quickly as possible
~Hemoperfusion with activated charcoal(160g)
~Immunosuppression with methylprednisolone
~Antioxidants (glutathione,1.2 gram iv twice a day)
~Supportive care"
16159169|NCT01709591|Behavioral|Prenatal education|
16159170|NCT01709578|Drug|Sarilumab|Pharmaceutical form:solution Route of administration: subcutaneous
16159171|NCT01709578|Drug|placebo|Pharmaceutical form:solution Route of administration: subcutaneous
16159172|NCT01709578|Drug|hydroxychloroquine|Dispensed according to the local practice.
16159173|NCT01709578|Drug|methotrexate|Dispensed according to the local practice.
16159174|NCT01709578|Drug|sulfasalazine|Dispensed according to the local practice.
16159175|NCT01709578|Drug|leflunomide|Dispensed according to the local practice.
16159176|NCT01709552|Behavioral|Computer Intervention|Patients randomized to the computer intervention will complete the B-SAFER computer program during their emergency department visit.
16159177|NCT01709552|Behavioral|Control|Patients randomized to the control arm will receive a time-equivalent computer-based program unrelated to substance use or partner violence.
16159178|NCT01709539|Procedure|Diagnostiskt Centrum|Patients who are suspected of having cancer after investigation at the primary care center will be referred to Diagnostiskt Centrum. Each patient who is referred to Diagnostiskt Centrum will undergo the following: (1) clinical chemistry/microbiology tests; (2) medical history; (3) objective clinical examination; and (4) taking of blood samples for analysis of biomarkers. If necessary, patients will also undergo the following: (5) additional laboratory tests; (6) biopsy; (7) X-ray of painful joints; (8) CT scan of the neck, thorax, abdomen, and/or pelvis; (9) mammography and gynecological examination; (10); gastroscopy and/or colonoscopy; and (11) further investigation (e.g., PET-CT scan).
16159179|NCT01709526|Behavioral|Improvement after psychiatric inpatient treatment|Cognition, psychosocial functioning
16159180|NCT01709513|Drug|Atorvastatin|Atorvastatin over-encapsulated tablets.
16159181|NCT01709513|Drug|Ezetimibe|Ezetimibe over-encapsulated tablet.
16159182|NCT01709513|Drug|Alirocumab|Alirocumab SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.
16159183|NCT01709513|Drug|Placebo|Placebo for alirocumab, ezitimibe and atorvastatin.
16159184|NCT01709500|Drug|LMT (atorvastatin, simvastatin, or rosuvastatin)|
16159185|NCT01709500|Drug|alirocumab|Alirocumab administered as a subcutaneous (SC) injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.
16159186|NCT01709500|Drug|Placebo|Placebo matched to alirocumab administered as a SC injection of 1 mL into the abdomen, thigh, or outer area of the upper arm.
16159187|NCT01709487|Procedure|HIPEC|HIPEC with cisplatin 50 mg/m2 intraperitoneally at the end of surgery
16159188|NCT01709474|Drug|Vitamin D3 6000 IU|Subjects will receive 6,000 IU of vitamin D3 by mouth daily until the subject's serum 25(OH) level is ≥ 40ng/mL at which point the supplementation dose will be reduced to 4,000 IU/day. Note: Subjects weighing <40 kilograms (kg) at study entry will receive their dose five days a week and all other subjects seven days a week.
16159189|NCT01709474|Drug|Vitamin D3 400 IU|Subjects will receive 400 IU/day of vitamin D3 daily by mouth.
16159190|NCT01709435|Drug|Cabozantinib S-malate|Given PO
16159191|NCT01709435|Other|Laboratory Biomarker Analysis|Correlative studies
16159192|NCT01709435|Other|Pharmacological Study|Correlative studies
16159193|NCT01709422|Drug|Propofol|Propofol is the sedative drug used as an additional sedation to one of the study arm.
16159194|NCT01709422|Drug|Midazolam|Midazolam is one of the two conventional sedative drugs included in both arms.
16159195|NCT01709422|Drug|Meperidine|Meperidine is one of the two conventional sedative drugs included in both arms.
16159196|NCT01709409|Drug|Curosurf-Group1|Maximum of 3 doses are administered to infants diagnosed with RDS.
16159197|NCT01709409|Drug|BLES-group 2|Maximum of 3 doses are administered to infants with RDS
16159198|NCT01709396|Radiation|ED-TBI|Patients will receive 18Gy ED-TBI in 8 fractions of 2.25 Gy each, twice/day for 4 days. Following the final fraction of TBI and an allogeneic hematopoietic stem cell graft.
16159199|NCT01709383|Device|Transcranial Direct Current Stimulation|The tDCS treatments will be applied bilaterally, with the anodal electrode placed on the left temple and the cathodal electrode placed on the right temple. The tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
16159200|NCT01709383|Device|Sham Stimulation|The sham tDCS will be applied at the beginning of 60-minute speech-language treatment sessions for five days across a one-week period.
16159201|NCT01709370|Drug|Letrozole, PD 0332991|
16159202|NCT01709357|Other|Muscle energy technique|The therapist, with one hand on the occipital bone and the other on the shoulder, performed passive side flexion, contralateral to the muscle, taking the subject's head until the end-feel. Then, subjects performed an isometric contraction of 25% of their maximum force, for 5 seconds, while the therapist offered manual resistance. Afterwards the subject was let to relax in this position for additional 5 seconds. Side flexion was now increased until a new end-feel point was reached. This sequence was repeated 3 times. At the end, the therapist passively guided the cervical segment to the neutral position.
16159203|NCT01709357|Other|Passive stretching technique|The therapist, with one hand on the occipital bone and the other on the shoulder, performed a contralateral side flexion of the muscle passively until the maximum obtainable amplitude was reached, while subjects were asked to breathe steadily. During the breathing phase the therapist increased the side flexion until the end of the obtainable amplitude, this position was maintained. This procedure was repeated during 30 seconds. Finally the therapist passively guided the cervical segment to the neutral position.
16159204|NCT01709357|Other|Ischemic compression technique|"The therapist, with a pincer contact, applied gradual pressure on the latent trigger point of the upper trapezius muscle. Subjects had been previously asked to say when pain was moderate but bearable, a pain value of 7 in a 1 to 1o scale of pain (in which 1 corresponds to no pain and 10 do unbearable pain). At this point, pressure was maintained until pain levels were reduced to level 3. The therapist increased once more the pressure until the level of pain was 7 again. This procedure was repeated during 90 seconds."
16159248|NCT01709110|Drug|Placebo|"Teriparatide arm placebo administered orally.
~Risedronate arm placebo administered SC."
16159205|NCT01709357|Other|Sham technique|The therapist was seated at the head of the treatment table, and with one hand on the occipital bone and the other on the shoulder, without executing any movement, for 30 seconds.
16159206|NCT01709344|Behavioral|PS-OT|
16159207|NCT01709344|Other|Usual care|Supportive and rehabilitation services available at DHMC
16159208|NCT01709331|Drug|Corifollitropin alfa|Corifollitropin alfa 150 μg by SC injection, once every 2 weeks for 52 weeks
16159209|NCT01709331|Drug|hCG|hCG 1500 or 3000 IU by SC injection twice a week; administered alone for 16 weeks (pre-treatment phase) and then in combination with corifollitropin alfa for 52 weeks (combined treatment phase)
16159210|NCT01709318|Drug|Nomegestrol acetate (NOMAC)|Daily release of 500, 700, or 900 μg.
16159211|NCT01709318|Drug|Etonogestrel (ENG)|Daily release of 75, 100, 120 or 125 μg
16159212|NCT01709318|Drug|Ethinyl estradiol (EE)|Daily release of 15 μg
16159213|NCT01709318|Drug|Estradiol (E2)|Daily release of 300 μg
16159214|NCT01709305|Drug|Metformin|Metformin, 500 mg or 850 mg oral tablets, twice or three times a day (BID or TID) for a total dose of at least 1500 mg daily; administered with food.
16159215|NCT01709305|Drug|Sitagliptin|Sitagliptin, 100 mg oral tablet, once daily (QD); administered with or without food
16159216|NCT01709305|Drug|Acarbose|Acarbose, 50 mg oral tablets, TID (150 mg total daily dose); administered with the first bite of each main meal.
16159217|NCT01709305|Drug|Repaglinide|Repaglinide, 0.5 mg and/or 1 mg oral tablets, TID (up to 16 mg daily); administered within 30 minutes of each meal.
16159218|NCT01709305|Drug|Glimepiride|Glimepiride, 1 mg and/or 2 mg oral tablets, QD (up to 6 mg daily); administered before the first main meal of the day
16159219|NCT01709305|Drug|Gliclazide|Gliclazide, 30 mg oral tablets, QD or BID (30 mg to 120 mg total daily dose); administered with meal.
16159220|NCT01709292|Drug|Vemurafenib (All Groups)|960 mg by mouth 2 times a day 56 days prior to surgery (patients not planned for surgical resection will have a core biopsy at day 56.
16159221|NCT01709292|Drug|Vemurafenib (Post Surgery) - Group A + C|"Group A: 960 mg by mouth twice a day 2 weeks post-surgery. Restaged 8 weeks after resuming drug. If patients demonstrate either stable or regressing disease, they will continue on vemurafenib with restaging occurring every 8 weeks until they are no longer benefitting from the drug.
~Group C: Patients not scheduled for surgical resection undergo a CT scan and core biopsy at day 56. Vemurafenib 960 mg by mouth twice a day, continued unless there is evidence of progressive disease on day 56 CT scan. Patients restaged every 8 weeks and continue vemurafenib until no longer benefitting from the drug. Patients evaluated for resectability after each CT scan is performed. If patient is scheduled for resection, then patient will continue vemurafenib until surgery and will follow the same treatment schema as patients in Groups A and B."
16159222|NCT01709292|Other|Post Surgery - Group B|Patients who have had a complete surgical resection, and who do not have evidence of metastatic disease will discontinue vemurafenib after surgery. Patients restaged with CT neck 8 weeks after surgery.
16159223|NCT01709279|Biological|adipose tissue derived stromal cells dosage|intra-coronary administration of autologous adipose tissue derived stroma cells
16159224|NCT01709266|Dietary Supplement|Probiotics|
16159225|NCT01709266|Dietary Supplement|Placebo|
16159226|NCT01709253|Radiation|proton beam therapy|hypofractionation study using proton beam therapy for prostate adenocarcinoma
16159227|NCT01709240|Device|BioWeld1 System|External skin layer closure of C-section incision by the BioWeld1 system. Removal of Chitoplast on day 4-7 post procedure.
16159228|NCT01709227|Drug|Furosemide|Patients randomized to the furosemide arm will be given 1 mg/kg intravenously every 6 hours for 2 doses and then as directed by CICU attending to augment urine output. Patients within this arm who have urine output <1 ml/kg/hr over 16 hours after the first dose of Lasix will be considered poor responders. These patients may be started on PD if clinically indicated. Those who show good response (urine output >1 ml/kg/hr over subsequent 16 hours) will continue furosemide as needed to augment urine output. If they subsequently develop oliguria or fluid overload unresponsive to diuretic therapy, these patients may later be started on PD at discretion of CICU attending with consultation of nephrology service.
16159229|NCT01709227|Procedure|Peritoneal Dialysis|Patients within the PD arm will begin PD with a standardized dialysis plan of 10ml/kg of 1.5% Dianeal™ with 1 hours cycles (5 minute fill, 45 minute dwell and 10 minute drain). Further PD management and discontinuation will be directed by CICU attending and Nephrology service.
16159230|NCT01709214|Drug|Cebranopadol (GRT6005) Low-Dose Range|Capsules
16159231|NCT01709214|Drug|Cebranopadol (GRT6005) High-Dose Range|Capsules
16159232|NCT01709214|Drug|Placebo|Capsules that did not contain active substance but appeared identical to the cebranopadol and oxycodone CR capsules
16159233|NCT01709214|Drug|Oxycodone CR|Capsules containing oxycodone CR 10 or 20 milligrams
16159234|NCT01709201|Behavioral|Brief Intervention|Those in the intervention arm will undergo a 10-minute discussion with a trained interventionist aimed at encouraging decreased substance use.
16159235|NCT01709188|Behavioral|Musical Dual Task Training|
16159236|NCT01709188|Behavioral|Walking and Talking|
16159237|NCT01709175|Behavioral|Strength Training|This is a 13 week strength training program. Sessions will be supervised by a Certified Exercise Physiologist in a group setting.
16159238|NCT01709162|Biological|Ipilimumab|
16159239|NCT01709162|Drug|Chemotherapy|
16159240|NCT01709149|Drug|CK-2017357|CK-2017357 125 mg tablets twice daily
16159241|NCT01709149|Other|Placebo tablets|Tablets
16159242|NCT01709149|Drug|Riluzole|Tablets
16159243|NCT01709136|Drug|Sirolimus|Single dose SRL pharmacokinetics and TAC steady state pharmacokinetics: This phase is applicable to both sets of patients: those with nephrotoxicity and those with hypertension. Patients will receive a single dose of SRL of 2 mg/m2. Blood sampling will be performed over a 24 hour stay in the Children's Hospital of Pittsburgh's Pediatric Clinical and Translational Research Center (PCTRC) - See more at: http://www.chp.edu/research/our-facilities/pctrc, and the sampling for 48 hour and 72 hour PK studies can be done at the outpatient lab. This phase can either be performed immediately after the 12-hour iothalamate GFR evaluation, or a few days later at the convenience of the subject.
16159244|NCT01709123|Drug|chromium niacinate|200ug or 500ug supplementation in pill form
16159245|NCT01709123|Drug|placebo|Placebo pill for chromium niacinate
16159246|NCT01709110|Drug|Teriparatide|Administered SC
16159251|NCT01709084|Drug|Rilpivirine|Type=exact number, unit=mg, number=25, form=tablet, route=oral. Rilpivirine will be administered in a fixed dose combination along with tenofovir disoproxil fumarate and emtricitabine, as a single dose tablet.
16159252|NCT01709084|Drug|Efavirenz|Type=exact number, unit=mg, number=600, form=tablet, route=oral. Efavirenz will be administered in a fixed dose combination along with tenofovir disoproxil fumarate and emtricitabine, as a single dose tablet.
16159253|NCT01709084|Drug|Tenofovir disoproxil fumarate|Type=exact number, unit=mg, number=300, form=tablet, route=oral. Tenofovir disoproxil fumarate will be administered in a fixed dose combination along with rilpivirine and emtricitabine in Group 1, and along with efavirenz and emtricitabine in Group 2.
16159254|NCT01709084|Drug|Emtricitabine|Type=exact number, unit=mg, number=200, form=tablet, route=oral. Emtricitabine will be administered in a fixed dose combination along with rilpivirine and tenofovir disoproxil fumarate in Group 1, and along with efavirenz and tenofovir disoproxil fumarate in Group 2.
16159255|NCT01709071|Drug|IPV|
16159256|NCT01709071|Drug|Low dose Sabin-IPV|
16159257|NCT01709071|Drug|Low dose adjuvanted Sabin-IPV|
16159258|NCT01709071|Drug|Middle dose Sabin-IPV|
16159259|NCT01709071|Drug|Middle dose adjuvanted Sabin-IPV|
16159260|NCT01709071|Drug|High dose Sabin-IPV|
16159261|NCT01709071|Drug|High dose adjuvanted Sabin-IPV|
16159262|NCT01709058|Drug|Intramuscular/paravertebral injections of Oxygen-Ozone|"Medical Oxygen will be used as a part of the injected mixture (100% oxygen, 200 bar compressed gas in steel cylinder with valve 14 with an integrated reductive). For the generation of the Oxygen-Ozone mixture a certified equipment OZONOSAN alpha plus will be used according to the D.L. 46/97, EEC Directive 93/42, class 2A with a photometer. The mixture of O2-O3 is produced through a method called silent discharge. Intramuscular/paravertebral injections to 3 cm from the spinal medial line will be performed introducing 5-20 mL of oxygen-ozone to each point, at a concentration of 10-20 micrograms/mL, for a total volume of 40 mL"
16159263|NCT01709058|Other|Simulated intramuscular/paravertebral injections|The simulated treatment administration will mimic the treatment in the area to be treated by pricking the skin with the needle without drilling. A light massage will be practice by hand and the application area will be covered with a bandage adhesive leaving the patient in the prone position for 10-15 minutes.
16159264|NCT01709045|Other|Magnetic Resonance Imaging (MRI)|Multi-sequence MR protocol
16159265|NCT01709045|Radiation|Dual-Energy Computed Tomography (DECT)|
16159266|NCT01709045|Other|Ultrasound|
16159267|NCT01709045|Other|Transcranial doppler|
16159268|NCT01709032|Drug|Deferasirox and deferiprone|
16159269|NCT01709019|Biological|Low dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28)|0.5mL IM injections
16159270|NCT01709019|Biological|Low dose RSV-F Vaccine without Adjuvant (Day 0); Seasonal TIV (Day 0 & day 28)|0.5mL IM injections
16159271|NCT01709019|Biological|High dose RSV-F Vaccine with Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28)|0.5mL IM injections
16159272|NCT01709019|Biological|High dose RSV-F Vaccine without Adjuvant (Day 0); Seasonal TIV (Day 0 & Day 28)|0.5mL IM injections
16159273|NCT01709019|Biological|Placebo (Day 0 & Day 28); Seasonal TIV (Day 0)|0.5mL IM Injections
16159274|NCT01709006|Radiation|Modulated radiotherapy (IMRT) using RapidArc® or Helical Tomotherapy® at a dose of 70 Gy in 33 fractions to the PTV (GTV) and 59.4 Gy in 33 fractions|Modulated radiotherapy (IMRT) using RapidArc® or Helical Tomotherapy® at a dose of 70 Gy in 33 fractions to the PTV (GTV) and 59.4 Gy in 33 fractions
16159275|NCT01708993|Drug|Pemetrexed and Reolysin (and safety run-in)|Pemetrexed: 500 mg/m², IV (10 min) - Day 1 every 3 weeks Reolysin: 4.5 x 10^10 TCID50 IV (1 hour) - Days 1-3, every 3 weeks
16159276|NCT01708993|Drug|Pemetrexed|Pemetrexed: 500 mg/m² IV (10 min) - Day 1 every 3 weeks
16159277|NCT01708993|Drug|Docetaxel and Reolysin|Docetaxel: 75 mg/m² IV (1 hour) - Day 1 every 3 weeks Reolysin: 4.5x10^10 TCID50 IV (1 hour) - Days 1-3, every 3 weeks
16159278|NCT01708993|Drug|Docetaxel|Docetaxel: 75 mg/m² IV (1 hour) - Day 1 every 3 weeks
16159279|NCT01708980|Other|Six different strength training exercises|"Electromyographic (EMG) activity of the vastus medialis, vastus lateralis, semitendinosus and biceps femoris muscles of the operated leg will be recorded during 6 different strength training exercises. The six exercises performed unilaterally are: seated knee extensions and leg presses in machines (gold standard exercises), and the four other exercises are: sit-to-stands, squats, straight leg raises and seated knee extensions using an elastic band.
~The relative loading will be 10 repetition maximum (RM). The absolute load (kilograms) corresponding to 10 RM of the 6 strength training exercises is defined a minimum of 3 days before the day where the EMG-data are recorded. Range of motion and time under tension for each repetition will be controlled for."
16159280|NCT01708967|Procedure|pretreatment method for transnasal endoscopy|"Catheter-free method : The patient then takes simethicone (10cc). After that, the nasal cavity is sprayed with epinephrine (1cc) and lidocaine HCL (4%, 4cc).
~Catheter inesertion method: After preparation steps the same as in the 'catheter-free' method, a 14 Fr. flexible catheter is coated with 2% lidocaine HCL gel and 8% lidocaine HCL spray. After that, the catheter is inserted into the patient's nasal cavity, and maintained about 1 minute for anesthesia. A 16 Fr. catheter is prepared by the same method with as the 14Fr. catheter. After the 14 Fr. cathter has been removed from the patient's nasal cavity, the 16 Fr. catheter is inserted into the patient's nasal cavity."
16159284|NCT01708941|Biological|Ipilimumab|Given IV
16159285|NCT01708941|Other|Laboratory Biomarker Analysis|Correlative studies
16159286|NCT01708941|Biological|Recombinant Interferon Alfa-2b|Given IV or SC
16159287|NCT01708928|Device|Ulthera System Treatment|Focused ultrasound energy delivered below the surface of the skin
16159288|NCT01708915|Drug|nicoboxil|2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
16159289|NCT01708915|Drug|placebo matching nonivamide + nicoboxil|2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
16159290|NCT01708915|Drug|nonivamide + nicoboxil (Finalgon)|2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
16159396|NCT01708109|Procedure|clearance of bile ductus|biliary calculus removed at surgery
16159291|NCT01708915|Drug|nonivamide|2cm ointment line for a skin area of approximately 20 cm x 20 cm up to 3 times in a 24h period
16159292|NCT01708902|Drug|linagliptin2.5mg/metformin1000mg|linagliptin2.5mg/metformin1000mg BID
16159293|NCT01708902|Drug|linagliptin2.5mg/metformin1000mg|linagliptin2.5mg/metformin1000mg BID
16159294|NCT01708902|Drug|linagliptin 5mg|linagliptin 5mg once daily
16159295|NCT01708902|Drug|Metformin 500mg|Metformin 500mg BID
16159296|NCT01708902|Drug|linagliptin2.5mg/metformin500mg|linagliptin2.5mg/metformin500mg BID
16159297|NCT01708902|Drug|linagliptin2.5mg/metformin500mg|linagliptin2.5mg/metformin500mg BID
16159298|NCT01708902|Drug|linagliptin 5mg|linagliptin 5mg once daily
16159299|NCT01708902|Drug|Metformin 1000mg|Metformin 1000mg BID
16159300|NCT01708889|Biological|BMS-914143 (Peginterferon Lambda-1a)|
16159301|NCT01708876|Drug|Artesunate-mefloquine|
16159302|NCT01708876|Drug|Chloroquine|
16159303|NCT01708876|Drug|Primaquine|Given to P. vivax patients only. Delayed administration at day 28; 0.5mg/kg for children or 45mg for adults; normal G6PD activity (once daily administration for 14 days); moderate G6PD deficiency (once weekly for 8 weeks); severe G6PD deficiency (contraindicated / not given).
16159304|NCT01708850|Drug|Rivaroxaban|All specified in arm description. One arm study.
16159305|NCT01708837|Drug|Propofol|Propofol infusion rate is titrated to maintain the target BIS values
16159306|NCT01708824|Behavioral|Dietary|"Dietary intervention to meet the target of
~<5 servings of red/processed meat weekly; <2 servings would be processed meat
~2 servings of refined grains daily"
16159307|NCT01708824|Behavioral|Physical activity|"Physical activity intervention with the following targets:
~General health target - 30 minutes of moderate-to-vigorous physical activity (MVPA) 5 days per week (i.e. 10 MET-hours/week);
~Cancer outcome target - 60 minutes of MVPA 5 days per week (i.e. 18-20 MET-hours/week)"
16159308|NCT01708798|Drug|Eplerenone|
16159309|NCT01708798|Drug|Placebo|
16159310|NCT01708785|Behavioral|Single food Cue Exposure Treatment|Subjects will be exposed to the same set of 4 foods in each cue exposure treatment session.
16159311|NCT01708785|Behavioral|Multiple food Cue Exposure Treatment|Subjects will be exposed to a different set of 4 foods in each cue exposure treatment session.
16159312|NCT01708785|Behavioral|Partial Reinforcement - Enhanced Cue Exposure Treatment|Subjects will take random additional tastes of the food during cue exposure treatment.
16159313|NCT01708785|Behavioral|Partial Reinforcement -Consistent Cue Exposure Treatment|Subjects will consistently take the same tastes of the food during cue exposure treatment.
16159314|NCT01708733|Drug|KSY|Chinese herbal formula
16159315|NCT01708720|Drug|IPV|
16159316|NCT01708720|Drug|Sabin-IPV|
16159317|NCT01708720|Drug|Adjuvanted Sabin-IPV|
16159318|NCT01708707|Drug|Buprenorphine|"The injectable formulation of buprenorphine (Buprenex; Reckitt Benckiser) will be prepared to a final concentration of 0.075 mg/mL in 100% ethanol and simple syrup USP to create a sublingual preparation.
~Infants initial dose: 15.9 µg/kg per day in 3 divided doses with escalation/weaning based upon standardized scoring of NAS symptoms, using standardized Finnegan scoring Maximum dosage: 60 µg/kg per day Duration: Infants will receive buprenorphine until they are successfully weaned off of opioids and no longer show withdrawal symptoms, evidenced by low Finnegan scores. Mean use in other investigations was 24 days."
16159319|NCT01708707|Drug|Morphine Sulfate|Oral Morphine Sulfate Dosage: Morphine Sulfate Oral Solution 100mg/5mL Initially dosed at 0.4mg/kg per day in six daily doses Duration of medication administration dependent upon infant symptoms of neonatal withdrawal, with mean duration of use at Banner Good Samaritan Hospital currently averaging 25 days.
16159320|NCT01708694|Dietary Supplement|Amylose|One group of participants will consume a yogurt containing 45 g of amylose (the slowly digesting starch) for 3 months.
16159321|NCT01708694|Dietary Supplement|Amylopectin|"The second group will consume a yogurt containing 45 g of a different starch called amylopectin (the placebo) for 3 months."
16159322|NCT01708681|Dietary Supplement|Lean seafood|
16159323|NCT01708681|Dietary Supplement|Meat, egg, milk|
16159324|NCT01708668|Procedure|Epidural analgesia|
16159325|NCT01708668|Procedure|Combined spinal-epidural analgesia|
16159326|NCT01708668|Procedure|Continuous epidural infusion|
16159327|NCT01708668|Procedure|Intermittent epidural bolus|
16159328|NCT01708655|Other|Sweat Evaporimeter measurement|"The forearm will be cleaned with distilled water. Mineral oil will be applied to the surface of the skin after each injection.
~intracutaneous injection of 0.2 ml of atropine
~Stimulation and inhibition of sweating in an adjoining test area. Assessment of sweat secretion with an evaporimeter for 10 minutes after:
~Intracutaneous injection of 0.1 ml carbachol for stimulation of the cholinergic sweat secretion.
~intracutaneous injection of 0.2 ml atropine to Inhibit cholinergic sweat secretion
~intracutaneous injection of 0.2 ml beta-cocktail (atropine isoproterenol and aminophylline) for stimulation of beta-adrenergic sweat secretion .
~The procedure would take about 45 minutes."
16159329|NCT01708642|Drug|Adrenaline|Adrenaline infusion 0.05 microgram / kg / minute
16159330|NCT01708642|Drug|Placebo|Intraoperative isotonic saline infusion as placebo for adrenaline.
16159331|NCT01708629|Drug|210 mg brodalumab|210 mg brodalumab administered SC
16159332|NCT01708629|Drug|140 mg brodalumab|140 mg brodalumab administered SC
16159333|NCT01708629|Drug|ustekinumab|45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.
16159334|NCT01708629|Drug|placebo|placebo administered SC
16159335|NCT01708616|Drug|RO5285119|multiple doses
16159336|NCT01708616|Drug|RO5285119 placebo|multiple doses
16159337|NCT01708616|Drug|risperidone|single dose
16159338|NCT01708616|Drug|risperidone placebo|single dose
16159339|NCT01708603|Drug|210 mg brodalumab|210 mg brodalumab administered SC
16159340|NCT01708603|Drug|140 mg brodalumab|140 mg brodalumab administered SC
16159341|NCT01708603|Drug|ustekinumab|45 mg or 90 mg ustekinumab administered SC per the labeled dosing regimen.
16159342|NCT01708603|Drug|placebo|Placebo administered SC
16159343|NCT01708590|Drug|210 mg brodalumab|210 mg brodalumab administered subcutaneous (SC)
16159344|NCT01708590|Drug|140 mg brodalumab|140 mg brodalumab administered subcutaneous (SC)
16159345|NCT01708590|Drug|placebo|Placebo administered subcutaneous (SC)
16159346|NCT01708577|Device|Validation of the IPANEMA - measurement system|Control of the body conditions under real life conditions during a sportive activity.
16159347|NCT01708564|Biological|rhFVIIa|Patients will be administered low, intermediate and high doses of rhFVIIa
16159348|NCT01708551|Device|Ulthera System Treatment|Focused ultrasound energy delivered below the surface of the skin
16159349|NCT01708538|Drug|CXL|corneal crosslinking
16159350|NCT01708525|Device|Ulthera® System Treatment|Focused ultrasound energy delivered below the surface of the skin
16159351|NCT01708525|Other|Heavy Water|A tissue labeling model via the consumption of the stable isotope, deuterated water (heavy water). Heavy water consumed over the course of the 6-week study period for a direct kinetic measure of in vivo collagen synthesis. 60 ml (about 12 teaspoons) of heavy water (also called deuterated water or 2H2O), was consumed three times a day for the first five days. Starting on Day 6, two 60 ml doses of heavy water were consumed per day for the remaining 37 days.
16159352|NCT01708512|Device|Ulthera System Treatment|Focused ultrasound energy delivered below the surface of the skin
16159353|NCT01708499|Device|Ulthera System Treatment|Focused ultrasound energy delivered below the surface of the skin
16159354|NCT01708473|Drug|Advil|One (1) tablet 800 mg Advil one hour prior to treatment.
16159355|NCT01708473|Drug|Lortab|One (1) tablet 10/500 mg of Lortab one hour prior to treatment.
16159356|NCT01708473|Device|Ulthera System Treatment|Focused ultrasound energy delivered below the surface of the skin
16159357|NCT01708460|Device|Ulthera System Treatment|Focused ultrasound energy delivered below the surface of the skin.
16159358|NCT01708447|Drug|L.M.X.4.® cream|A lidocaine topical anesthetic cream
16159359|NCT01708447|Other|A placebo cream|Placebo cream containing no anesthetic properties.
16159360|NCT01708447|Device|Ulthera System Treatment|Focused ultrasound energy delivered below the surface of the skin
16159361|NCT01708434|Device|Ulthera® System|Focused ultrasound energy delivered below the surface of the skin
16159362|NCT01708408|Genetic|Biomarker studies|
16159363|NCT01708382|Device|Ulthera System Treatment|Focused ultrasound energy delivered below the surface of the skin
16159364|NCT01708369|Drug|Placebo|Orange juice administered 15 minutes before subjects take oseltamivir or aspirin
16159365|NCT01708369|Drug|Ethanol|Ethanol will be mixed with orange juice and subjects will drink the mixture 15 minutes before receiving oseltamivir or aspirin
16159366|NCT01708369|Drug|Oseltamivir|Oseltamivir 150 mg orally
16159367|NCT01708369|Drug|Aspirin|Aspirin 650 mg orally will be given
16159368|NCT01708356|Behavioral|Cycling on a residential route|
16159369|NCT01708343|Procedure|DIMMST|
16159370|NCT01708330|Drug|Lidocaine|2% Lidocaine gel
16159371|NCT01708330|Drug|Placebo gel|odorless, colorless gel will be used as a placebo
16159372|NCT01708317|Behavioral|ACASI|Youth who participated in this study completed the ACASI -- they provided details about their sexual history, and the software program used their responses to create a recommendation for chlamydia/gonorrhea testing. The information obtained through the ACASI was integrated into the emergency department (ED) electronic medical record. ED physicians and nurses were able to review the information and order chlamydia/gonorrhea testing if needed.
16159373|NCT01708304|Behavioral|RDAD|Exercise training for caregiver and care recipient. Behavioral modification training for caregiver.
16159374|NCT01708291|Behavioral|Mindfulness based stress reduction|an 8 week group intervention to teach mindfulness skills
16159375|NCT01708291|Behavioral|only pre and post evaluation measures|
16159376|NCT01708278|Drug|Quercetin|"COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take one of the following for 1 week
~Quercetin 500 mg/350 mg of vitamin C and 10 mg niacin
~Quercetin 1000 mg/350 mg of vitamin C and 10 mg niacin
~Quercetin 2000 mg/350 mg of vitamin C and 10 mg niacin"
16159377|NCT01708278|Other|Placebo - sugar chew|COPD Subjects will be asked to avoid quercetin rich diet for one week and then asked to take placebo (sugar chew containing 350 mg of vitamin C and 10 mg niacin)
16159378|NCT01708265|Other|Watchful waiting|In case of watchful waiting a conservative treatment is performed, based on close monitoring of the patient for clear signs of deterioration that triggers facilitated surgery before left ventricular dysfunction is present.
16159379|NCT01708265|Procedure|Early mitral valve repair|Patients in the group of early mitral valve repair will be operated by way of routine mitral valve repair procedures in specialized centres.
16159380|NCT01708252|Device|Ulthera System Treatment|Focused ultrasound energy delivered below the surface of the skin
16159381|NCT01708239|Other|Left rule, D-dimer measurement and complete ultrasonography in pregnant women.|Diagnostic strategy based on the LEFt rule, D-dimer measurement and complete ultrasonography
16159382|NCT01708226|Behavioral|Attention Modification Program|Computer-based attention training treatment designed to directly but implicitly modify biased attention patterns in anxious patients in service of symptom relief.
16159383|NCT01708213|Device|Aline HA|Implantable dermal filler
16159384|NCT01708200|Other|Memory Intervention|A comparison of two type of memory intervention protocols; a psychoeducational/intervention protocol versus a computerized memory protocol in a population of individuals with mental illness.
16159385|NCT01708187|Biological|Clarix™1k graft|"Group 1 will have standard peroneal repair surgery with the addition of the Clarix™1k tissue.
~Group 2 will have standard peroneal repair surgery without the use of the Clarix™1k tissue."
16159386|NCT01708174|Drug|LDE225|Sonidegib for oral suspension was supplied in amber glass bottles. Sonidegib oral suspension was combined with the supplied reconstitution vehicle to a final concentration of 50 mg/mL.
16159387|NCT01708174|Drug|TMZ|Temozolomide capsules were obtained locally by the Investigator
16159388|NCT01708161|Drug|BYL719|BYL719 is a small molecule inhibiting PI3-Kinase.
16159389|NCT01708161|Drug|AMG 479|AMG 479 is a monoclonal antibody directed against IGF1-R.
16159390|NCT01708148|Dietary Supplement|Probiotics|lyophilised L. rhamnosus, L. jensenii, L. crispatus, L. gasseri and sodium alginate
16159391|NCT01708148|Other|Placebo|control group would receive a oral lactose placebo
16159392|NCT01708135|Behavioral|Use of smartphone app|
16159393|NCT01708122|Drug|Fentanyl|100 mcg in 1 mL intranasal spray
16159394|NCT01708122|Drug|saline|Sodium Chloride 0.9% intranasal spray
16159397|NCT01708096|Dietary Supplement|Modifast|2 weeks before gastric by-pass patients are treated with VLD, 1000 kcal/day
16159398|NCT01708096|Dietary Supplement|Normal diet|normal diet 2 weeks before gastric by-pass
16159399|NCT01708070|Behavioral|Asthma self-management|Patients in the intervention group will receive an asthma workbook, will make a contract to adopt behaviors they think will improve asthma, will be taught how to use a peak flow meter and specific chapters of the workbook will be used as templates for focused instruction during telephone follow-ups which will occur every week for 8 weeks and then approximately every 2 months.
16159400|NCT01708057|Drug|AZD8683|AZD8683 administered via inhalation
16159401|NCT01708057|Drug|Placebo|Placebo administered via inhalation
16159402|NCT01708057|Drug|Tiotropium|Tiotropium administered via inhalation
16159403|NCT01708044|Drug|Pramlintide acetate|
16159404|NCT01708044|Other|Placebo|Placebo Comparator
16159405|NCT01708031|Other|physiological signals|
16159406|NCT01708018|Procedure|WATSU|"WATSU (WaterShiatsu) is a gentle form of hydrotherapy that was established in the 1980s. The standardized 60min-intervention applied in this trial is called WATSU-Transition-Flow (Dull, 1997) and is adapted for the third trimester. The mother's abdomen is not being touched during the treatment.
~The treatment takes place in a one-to-one hands-on-setting in the warm- water-therapy-pool (35°C, 95°F) of the University Hospital in Bern and consists of acupressure massage according to the Japanese massage-technique Shiatsu, in an attempt to harmonize the mother's energy-flow in the so called meridians (energy-channels) of Traditional Chinese Medicine. These meridians are also sought to be influenced by slow passive stretches of the mother's extremities. In addition, mobilization of her spine is being enhanced by gravity-free movements.
~During the study, each participant in the intervention group will be treated twice with WATSU (60min treatment at day 1 and 4)."
16159407|NCT01708005|Drug|Lecitone®Se-Vitamin D3|"Lecitone®Se-Vitamin D3 is a dietary supplement combining the active ingredients in Lecitone®Se and 100 IU of vitamin D3. This dietary supplement comes in capsule form.
~Participants take 2 capsules of Lecitone®Se -Vitamin D3 per day. The dose of vitamin D supplementation will not be adjusted except in case of an adverse event such as hypercalcemia. In this case, vitamin D supplementation is stopped and the participant is released prematurely from the study."
16159408|NCT01708005|Drug|Placebo|The comparator is represented by placebo capsules of identical appearance (same size, same color and same smell) that Lecitone®Se-Vitamin D3 capsules.
16159409|NCT01707992|Drug|Laquinimod|Laquinimod will be administered as per the dose and schedule specified in the respective arms.
16159410|NCT01707992|Drug|Placebo|Placebo matching to laquinimod will be administered as per the schedule specified in the respective arms.
16159411|NCT01707966|Drug|Orteronel|
16159412|NCT01707966|Drug|Placebo|
16159413|NCT01707953|Drug|Midodrine|Midodrine 5mg as capsule, administered twice (5 and 23 hours after end of surgery).
16159414|NCT01707953|Drug|Placebo|Placebo capsule to mimic midodrine
16159415|NCT01707940|Drug|Ketoconazole|Ketoconazole 400 mg / day
16159416|NCT01707940|Drug|BI 144807|BI144807 oral solution, intermediate dose
16159417|NCT01707940|Drug|BI 144807|BI144807 oral solution, intermediate dose
16159418|NCT01707914|Dietary Supplement|Chinese bayberry juice|Consume 500 mL CBJ/d (250 mL CBJ twice daily)
16159419|NCT01707914|Dietary Supplement|placebo|
16159420|NCT01707901|Drug|ONO-8539|Treatment
16159421|NCT01707901|Other|Placebo|Placebo
16159422|NCT01707888|Procedure|Thoracoscopy/VATS|Patients undergo major lung resection by thoracoscopic surgery or video assisted thoracoscopic surgery.
16159423|NCT01707875|Other|fetal brain neurosonography|fetal brain neurosonography according to the ISUG guidelines
16159424|NCT01707849|Drug|EVL arm|Patients will be randomized at day 28th post-transplant. This group will receive Tacrolimus+Everolimus.
16159425|NCT01707849|Drug|MMF arm|Patients will be randomized at day 28th post-transplant. This group will continue of current immunosuppressive regimen (Tacrolimus+MMF) / no everolimus introduction.
16159426|NCT01707823|Drug|acetylsalicylic acid|Given PO
16159427|NCT01707823|Other|laboratory biomarker analysis|Correlative studies
16159428|NCT01707810|Procedure|Piggyback method|In the piggyback method IVC was not clamped in any case. Implantation method of the grafted IVC in recipient IVC was not standardized, being defined by the responsible surgeon during the procedure. In the two groups, all patients were submitted to simultaneous arterial and portal revascularization, according to the routine of the service.
16159429|NCT01707810|Procedure|conventional method|
16159430|NCT01707771|Procedure|Roux-en-Y gastric bypass|Active Comparator: Roux-en-Y gastric bypass
16159431|NCT01707771|Behavioral|diet and lifestyle modifications|Active Comparator: diet and lifestyle modifications
16159432|NCT01707745|Procedure|Intravitreal Bevacizumab|
16159433|NCT01707732|Drug|Enoxaparin|Administration of Enoxaparin
16159434|NCT01707706|Other|Acupuncture|Acupuncture at bilateral Ear Shenmen, Sishencong EX-HN1 , Anmian , Neiguan PC6 , Shenmen HT7 , Sanyinjiao SP6 , and unilateral Yintang EX-HN3 and Baihui GV20. The needles will be left for 30 min and then removed. Acupuncture treatment will consist of three sessions per week for 3 consecutive weeks.
16159435|NCT01707693|Behavioral|Lifestyle Physical Activity Intervention|Physical Activity Information given plus Behavioral counseling using motivational interviewing & follow-up
16159436|NCT01707693|Behavioral|Information / Attention Comparison|Physical Activity information given & follow-up, no behavioral counseling
16159437|NCT01707680|Other|SOC|Patient are given standard of care
16159438|NCT01707667|Drug|prucalopride|One 2 mg tablet orally administered on Day 1
16159439|NCT01707667|Drug|PEG 3350|13.8g polyethylene glycol (PEG) 3350 with sodium bicarbonate, sodium chloride, and potassium chloride as a solution in water. Administered twice orally on Day 1(once in the morning and once prior to lunch).
16159440|NCT01707654|Device|Nerve flap|Based on the Teoh et al.'s technique, we combined the nerve graft into the bipedicled heterodigital arterialized island flap and used this composite flap tissue for reconstructing complicated infected wound in the finger.
16159441|NCT01707641|Dietary Supplement|CD#2|patient will be asked to take 6 lozenges every day and let it dissolve slowly in the mouth
16159442|NCT01707641|Other|bicarbonate sodium mouthwash|Patients will be asked to wash their mouth with bicarbonate sodium several times per day
16159444|NCT01707615|Drug|GSPE|GSPE 240 mg/day (120mg bid)
16159445|NCT01707615|Other|lifestyle intervention|dietary modification making the total ingestion of calories into standard body weight 25 kCal in effect and an individualized home exercise program of a minimum 150 min/week of moderate-intensity physical activity
16159446|NCT01707602|Biological|INTANZA® 15|intradermal vaccination
16159447|NCT01707602|Biological|Vaxigrip®|Intramuscular vaccination
16159448|NCT01707602|Biological|INTANZA® 15 T|transcutaneous vaccination
16159449|NCT01707589|Device|The new sensor is not on the market. We have named it Elfi-sensor.|Participating subjects will be monitored for one hour with a noninvasive sensor.The noninvasive sensor, the size of a penny, will be affixed to the skin, above the umbilicus, with pediatric adhesive tape. The monitor will record continuously the heart rate, cardiac rhythm, respiratory rate and body motion.
16159450|NCT01707576|Behavioral|consultation 10 days later|new depression screening
16159451|NCT01707563|Procedure|skin punch biopsy and molecular biology|
16159452|NCT01707563|Other|fibroblast culture and molecular biology|
16159453|NCT01707537|Biological|Euvichol|1.5mL/vial, 1vial at 2-week intervals twice
16159454|NCT01707524|Procedure|Randomized left versus right radial artery approach|Randomized left versus right radial artery approach
16159455|NCT01707498|Procedure|Scanning device|Patients will be asked to spell a text with a specific scanning device. The most appropriate contactor or clicking device will be chosen by a senior therapist.
16159456|NCT01707498|Procedure|RoBIK Brain-Computer Interface|Patients will be asked to spell a text with the BCI
16159457|NCT01707472|Biological|Simtuzumab|700 mg intravenously for a total of 12 infusions.
16159458|NCT01707446|Device|Cerebral oximetry monitor (The INVOS® Cerebral/Somatic Oximeter)|In the intervention group, an alarm threshold at 75% of the baseline rSO2 value will be established. Based on predetermined algorithm the rSO2 will be maintained at or above 75% of the baseline measurements.
16159459|NCT01707446|Other|An alarm threshold at 75% of the baseline rSO2 value|If the threshold of < 75% from baseline is reached for > 1 minute an algorithm geared to restore rSO2 to baseline levels will be implemented.
16159460|NCT01707433|Other|Enzyme testing|Leukocyte activity measurement of Arylsulfatase B and N acetyl galactosamine 6 sulfatase (GALNS)
16159461|NCT01707420|Drug|Gabapentin|The active comparator, Gabapentin, is a structural analog of g-aminobutyric acid which has anticonvulsant properties. This study is a prospective randomized double-blinded trial examining the effectiveness of a single dose of liquid Gabapentin given 60 minutes prior to surgery for pain management in pediatric tonsillectomy/adenoidectomy pediatric patients.
16159462|NCT01707420|Drug|liquid placebo|Subjects randomized to the liquid placebo will receive an identical appearing liquid placebo of 0.4mL/kg.
16159463|NCT01707407|Drug|Pomalidomide|4 mg pomalidomide capsule administered orally once in the morning
16159464|NCT01707407|Drug|Ketoconazole|200 mg Ketoconazole tablet administered orally twice a day on Days 1-7.
16159465|NCT01707407|Drug|Fluvoxamine|50 mg Fluvoxamine tablet administered orally twice a day on Days 1-7.
16159466|NCT01707407|Drug|Carbamazepine|"100 mg Carbamazepine tablet administered orally once in the evening on Day 1
~100 mg Carbamazepine tablet administered orally twice daily on Days 2-3
~200 mg Carbamazepine tablet administered orally twice daily on Days 4-11"
16159467|NCT01707394|Drug|Apixaban|Specified dose on specified days
16159468|NCT01707381|Drug|BOL-303259-X|Topical ophthalmic solution
16159469|NCT01707381|Drug|Timolol maleate|Topical ophthalmic solution
16159470|NCT01707368|Drug|Daivobet® Gel|Once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance.
16159471|NCT01707355|Behavioral|intervention - poster|
16159472|NCT01707342|Drug|Simeprevir (TMC435)|Treatment A: Simeprevir (TMC435) 50 mg; and Treatment B: Simeprevir (TMC435) 150 mg; will be followed 5 hours later by a single 10 minute intravenous infusion of [3H]-TMC435 (100 microcurie) 100 microgram in Period 1 and Period 2, respectively.
16159473|NCT01707329|Drug|Chemotherapy|Docetaxel 60-75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.
16159474|NCT01707329|Drug|Icotinib+chemotherapy|Icotinib: 125 mg is administered orally three times per day. Chemotherapy: docetaxel 75mg/m2, 4 cycles; or pemetrexed 500mg/m2, 4 cycles.
16159475|NCT01707316|Drug|Treatment A: Canagliflozin 100 mg|Volunteers will receive one 100 mg over-encapsulated tablet of canagliflozin as a single oral (by mouth) dose on Day 1.
16159476|NCT01707316|Drug|Treatment B: Canagliflozin 300 mg|Volunteers will receive one 300 mg over-encapsulated tablet of canagliflozin as a single oral dose on Day 1.
16159477|NCT01707316|Other|Treatment C: Placebo|Volunteers will receive one matching placebo (inactive medication) capsule as a single dose on Day 1.
16159478|NCT01707303|Other|Early ICU rehabilitation strategies|Physical therapy - standard; Physical therapy, progressive resistance training for 2nd physical therapy session in Cohort II
16159479|NCT01707303|Other|Usual Care|All typically applied hospital rehabilitative services applied in the usual fashion
16159480|NCT01707290|Drug|Ivacaftor|150 mg tablet, oral use, every 12 hours (q12h)
16159481|NCT01707277|Other|Inspiratory muscle training|Patients were instructed to train at home twice daily for 20 minutes each session during 12 weeks with a threshold inspiratory muscle trainer (Threshold IMT®, Respironics Inc.). All of them were trained under the supervision of a physiotherapist and educated to maintain diaphragmatic breathing during training. The subjects started breathing at a resistance equal to 25-30% of their maximum inspiratory pressure for 1 week.
16159482|NCT01707277|Other|Usual care|Usual pahramacological treatment
16159483|NCT01707264|Drug|NEOD001|Monoclonal antibody administered by intravenous infusion every 28 days.
16159484|NCT01707251|Drug|Intravenous Ibuprofen|800 mg Ibuprofen IV every 6 hours starting preoperatively (5 doses).
16159485|NCT01707251|Drug|Saline|Placebo control
16159486|NCT01707238|Device|etafilcon A|Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
16159487|NCT01707238|Device|stenfilcon A|Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
16159536|NCT01706991|Device|Pediatric Vision Scanner eye scan|Subject is scanned with a 2.5 second pediatric vision scanner device test.
16173400|NCT01596855|Drug|Epoetin Alfa|TIW
16159488|NCT01707225|Drug|Octreotide LAR Depot|The subject will be seen in clinic every 4 weeks (+/- 4 days) through week 24. During weeks 25-36 the subject will receive a telephone call every 4 weeks +/- 4 days, from the research nurse to assess for changes occurring after the study drug was stopped. Subjects will receive a physical exam and interview at each visit to assess for any sign of GI bleeding at home as per standard protocol for HeartMate II patients and for potential drug related side effects. Labs collected for research will include monthly basic metabolic panel (BMP), complete blood count (CBC), fructosamine and quarterly HGbA1C , VEGF, vWF, vWF activity assay, thyroid stimulating hormone (TSH), platelet function test and fibrinogen. Subjects will receive their monthly injection while in clinic for their every 4 weeks appointment. The subjects will be followed and data will be collected for 36 weeks, or for as long as they are enrolled in the study.
16159489|NCT01707212|Behavioral|Pain management education|Education about pain management during infant immunization
16159490|NCT01707212|Behavioral|No pain management education|Control - no education about pain management during infant immunization
16159491|NCT01707199|Drug|Artesunate + Sulphadoxine-pyrimethamine|"AS+SP will be administered according to the patient's age, based on a dose of 4mg artesunate/kg body weight once daily for 3 days plus SP at a dose of 25mg sulphadoxine/kg body weight single dose on the first day.
~One co-blister pack of Artecospe will be used per patient and obtained via WHO from Guilin Pharmaceutical Co. Ltd., Shanghai China, with appropriate expiry date."
16159492|NCT01707173|Behavioral|Tailored education|Using information gleaned from interviews, educational print materials tailored to the participant's beliefs about infant safe sleep practices, will be mailed to the participants home at 2 separate times over a 6 month period along with a culturally relevant DVD with safe sleep information
16159493|NCT01707173|Behavioral|Standard Education|Participants will receive currently available publications about infant sleep from the American Academy of Pediatrics and the AAP at 2 separate times over a 6 month period along with a generic DVD about infant safety practices
16159494|NCT01707160|Drug|biphasic insulin aspart 30|One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order
16159495|NCT01707160|Drug|biphasic human insulin 30|One single dose of each trial drug separated by 4-10 days injected subcutaneously (s.c, under the skin) in random order
16159496|NCT01707147|Drug|Trajenta tablet|Linagliptin
16159497|NCT01707134|Drug|insulin aspart|Injected subcutaneously (s.c, under the skin) as meal time insulin
16159498|NCT01707134|Drug|human soluble insulin|Injected subcutaneously (s.c, under the skin) as meal time insulin
16159499|NCT01707134|Drug|insulin NPH|Will be administrated subcutaneously (s.c, under the skin) once or twice daily as basal insulin
16159500|NCT01707108|Device|Dental Implant (MIS Technologies)|MIS Technologies Ltd. C1 Dental implants
16159501|NCT01707095|Other|Unbundling of cords|The active electrode and camera cords will be place off opposite sides of the table and will not run adjacent to or in parallel with one another
16159502|NCT01707095|Other|Bundling of cords|The cords from the camera/active electrode will be bundled together along their lengths during a laparoscopic cholecystectomy.
16159503|NCT01707082|Drug|PF-06282999|Tablet, 10 mg, every 8 hours, 14 days
16159504|NCT01707082|Drug|Placebo|Tablet, 0 mg, every 8 hours, 14 days
16159505|NCT01707082|Drug|PF-06282999|Tablet, 30 mg, every 8 hours, 14 days
16159506|NCT01707082|Drug|Placebo|Tablet, 0 mg, every 8 hours, 14 days
16159507|NCT01707082|Drug|PF-06282999|Tablet, 100 mg, every 8 hours, 14 days
16159508|NCT01707082|Drug|Placebo|Tablet, 0 mg, every 8 hours, 14 days
16159509|NCT01707082|Drug|PF-06282999|Tablet, 250 mg, every 8 hours, 14 days
16159510|NCT01707082|Drug|Placebo|Tablet, 0 mg, every 8 hours, 14 days
16159511|NCT01707082|Drug|PF-06282999|Tablet, 350 mg every 8 hours or 500 mg every 12 hours, 14 days
16159512|NCT01707082|Drug|Placebo|Tablet, 0 mg, every 8 or 12 hours, 14 days
16159513|NCT01707082|Drug|midazolam|Tablet, 7.5 mg, single dose on Period 1 Day 1 and Period 2 Day 14
16159514|NCT01707082|Drug|PF-06282999|Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days
16159515|NCT01707082|Drug|midazolam|Tablet, 7.5 mg, single dose on Period 1 Day 1 and Period 2 Day 14
16159516|NCT01707082|Drug|PF-06282999|Tablet, dose to be determined (determined in Part A), every 8 or 12 hours, 14 days
16159517|NCT01707069|Biological|CryJ2-DNA-LAMP plasmid vaccine by intramuscular injection|"Immunomic Therapeutics Inc. CryJ2-DNA-LAMP vaccine is a frozen product formulated in physiological saline and contains no preservative. The study product is packaged in a 1 ml volume in a 3 ml glass vial, with label complying with FDA requirements.
~Subjects will receive CryJ2-DNA-LAMP plasmid vaccine by intramuscular injection. The dosing regimen for this group will be to receive three (3) additional booster doses (4 doses in total) at 14 day intervals."
16159518|NCT01707056|Other|Black Coffee|Taking Synthroid with 12 ounces of black coffee for 6 weeks.
16159519|NCT01707056|Other|Coffee with Milk|Taking Synthroid with 12 ounces of black coffee and 2 ounces of 2% milk for a period of 6 weeks.
16159520|NCT01707056|Other|Black Tea|Taking Synthroid with 12 ounces of black tea for a period of 6 weeks.
16159521|NCT01707056|Other|Water|Taking Synthroid with water for a period of 6 weeks.
16159522|NCT01707043|Drug|Taclonex|Subjects will be evaluated at baseline, Day 3 and Day 6 (or end of study).
16159523|NCT01707030|Other|Web-Based Brief Alcohol Intervention|Participants report their alcohol use and problems on line and receive feedback comparing them to national norms.
16159524|NCT01707030|Other|Usual Care|All patients will be receiving care in a Hepatitis C clinic. In some cases clinicians may counsel them on alcohol problems.
16159525|NCT01707017|Other|Strength training|
16159526|NCT01707004|Drug|decitabine|Given IV
16159527|NCT01707004|Drug|fludarabine phosphate|Given IV
16159528|NCT01707004|Drug|busulfan|Given IV
16159529|NCT01707004|Drug|cyclophosphamide|Given IV
16159530|NCT01707004|Drug|tacrolimus|Given PO or IV
16159531|NCT01707004|Drug|mycophenolate mofetil|Given PO
16159532|NCT01707004|Biological|filgrastim|Given SC
16159533|NCT01707004|Radiation|total-body irradiation|Undergo total-body irradiation
16159534|NCT01707004|Procedure|allogeneic bone marrow transplantation|Undergo allogeneic bone marrow transplantation
16159535|NCT01707004|Other|laboratory biomarker analysis|Correlative studies
16159537|NCT01706978|Procedure|Bone Trephination|
16159538|NCT01706978|Procedure|Soft Tissue Trephination|
16159539|NCT01706965|Drug|Kuvan|20mg/kg using a daily dosing schedule. To increase tolerability, treatment will be initiated at 10mg/kg for the first week of the study. Given the short length of the trial, no dose adjustments will be made for changes in weight
16159540|NCT01706965|Drug|Multivitamin|Multi-vitamin will be used as an active control in this study. Will be dosed daily
16159541|NCT01706952|Drug|Cocaine|Pledgets soaked in 4% cocaine hydrochloride solution were placed intranasally (one side).
16159542|NCT01706952|Drug|Adrenaline|Pledgets soaked in 1/1000 adrenaline solution were placed intranasally (one side).
16159543|NCT01706939|Radiation|Reduced Dose Radiation|Reduced Dose Radiation (5600 cGy) dose radiotherapy
16159544|NCT01706939|Radiation|Standard Dose Radiation|Standard Dose Radiation (7000 cGy) dose radiotherapy
16159545|NCT01706939|Drug|Carboplatin|Day 1, every 21 days ( + 2 days)
16159546|NCT01706926|Biological|Mavrilimumab 30 mg|Mavrilimumab (CAM-3001) 30 mg injection subcutaneously every 2 weeks for 24 weeks
16159547|NCT01706926|Biological|Mavrilimumab 100 mg|Mavrilimumab (CAM-3001) 100 mg injection subcutaneously every 2 weeks for 24 weeks.
16159548|NCT01706926|Biological|Mavrilimumab 150 mg|Mavrilimumab (CAM-3001) 150 mg injection subcutaneously every 2 weeks for 24 weeks.
16159549|NCT01706926|Other|Placebo|Placebo matched to mavrilimumab (CAM-3001) injection subcutaneously every 2 weeks for 24 weeks.
16159550|NCT01706913|Other|Dermatology consult|
16159551|NCT01706900|Other|Incubator Temp set to 36.5 degree|We will set incubator Temp to 36.5 so we can assess the outcome and compare the results with the placebo group.
16159552|NCT01706900|Other|Incubator Temp 37 degree|We will set incubator Temp to 37 degree as the routine embryo culture Temp since 1978 as the placebo arm.
16159553|NCT01706887|Other|Diet Amiloride|only arm of the trial
16159554|NCT01706874|Other|Periodontal prophylaxis|Periodontal scaling (every 6 months) plus mouthrinses plus toothbrushing (twice daily). Removal of adherent plaque and calculus with ultrasonic instruments and hand instruments, such as periodontal scalers and curettes, and polishing of the teeth
16159555|NCT01706861|Device|Celotres|Celotres following surgical removal of earlobe keloid.
16159556|NCT01706848|Other|Celotres|Surgical procedure will be performed as per the standard of care. Scar halves randomized to treatment with device (Celotres), opposite side treated per standard of care.
16159557|NCT01706848|Other|Surgical Closure by Standard of Care|Surgical procedure will be performed as per the standard of care. Scar halves randomized to treatment with device (Celotres), opposite side treated per standard of care.
16159558|NCT01706835|Drug|aldoxorubicin|
16159559|NCT01706822|Device|Covidien Radial Reload Stapler with Tri-Staple Technology|Case series of patients arlaedy selected to undergo a laparoscopic LAR using the Radial Reload stapler
16159560|NCT01706809|Other|blood sampels from vena rectalis superior and vena cubiti|
16159561|NCT01706796|Drug|PF-06273340|Oral solution, single dose, fasted
16159562|NCT01706796|Drug|PF-06273340|Immediate Release Tablet, single dose, fasted
16159563|NCT01706796|Drug|PF-06273340|Modified Release Tablet (short duration, MR1), single dose, fasted
16159564|NCT01706796|Drug|PF-06273340|Modified Release Tablet (long duration, MR2), single dose, fasted
16159565|NCT01706796|Drug|PF-06273340|Modified Release Tablet (short duration, MR1), single dose, fed
16159566|NCT01706796|Drug|PF-06273340|Modified Release Tablet (long duration, MR2), single dose, fed
16159567|NCT01706783|Drug|somapacitan|Subcutaneous (s.c., under the skin) administration once weekly (Days 1, 8, 15 and 22) of 4 different doses of NNC0195-0092 (somapacitan) in an escalating order
16159568|NCT01706783|Drug|Norditropin NordiFlex®|Subcutaneous (s.c., under the skin) administration daily for 28 days. The daily dosing will be the same as the pre-trial daily dose of human growth hormone (hGH) taken by the adult with growth hormone deficiency
16159569|NCT01706770|Device|enfilcon A|
16159570|NCT01706770|Device|galyfilcon A|
16159571|NCT01706757|Device|go-cart|conducts exercises with the help of a go-cart
16159572|NCT01706744|Other|Intermediate care unit|
16159573|NCT01706744|Other|Local health care 1|
16159574|NCT01706744|Other|Local health care 2|
16159575|NCT01706731|Behavioral|Treatment as usual|Treatment as usual (TAU)is defined as the routine care provided to each individual patient at the geriatric psychiatry clinic of Maharaj Nakorn Chiang Mai Hospital.
16159576|NCT01706731|Behavioral|Cognitive-behavioral therapy|Cognitive behavioral therapy(CBT)includes psychoeducational components combined with cognitive interventions targeted at challenging negative automatic thoughts.
16159577|NCT01706718|Dietary Supplement|Bread|
16159578|NCT01706705|Device|Intracavitary Applicator Placement|MRI-compatible applicator inserted using ultrasound guidance to verify tandem placement in the uterus. Tandem and ovoids, tandem and cylinders, or tandem and ring chosen to accommodate patient's tumor and vaginal anatomy.
16159579|NCT01706705|Other|Computed Tomography (CT)|CT scan performed after implant is placed in operating room. CT scan should take about 20 minutes.
16159580|NCT01706705|Other|Magnetic Resonance Imaging (MRI)|MRI scan performed after implant is placed in the operating room. MRI should take about 45 minutes.
16159581|NCT01706692|Biological|Adalimumab|all dosages, frequencies and durations prescribed
16159582|NCT01706692|Biological|Etanercept|all dosages, frequencies and durations prescribed
16159583|NCT01706692|Biological|Infliximab|all dosages, frequencies and durations prescribed
16159584|NCT01706692|Biological|Ustekinumab|all dosages, frequencies and durations prescribed
16159585|NCT01706692|Drug|Cyclosporine A|all dosages, frequencies and durations prescribed
16159586|NCT01706692|Drug|Fumaric acids|all dosages, frequencies and durations prescribed
16159587|NCT01706692|Drug|Methotrexate|all dosages, frequencies and durations prescribed
16159588|NCT01706692|Drug|Other anti-psoriatic systemic treatments|all dosages, frequencies and durations prescribed
16159589|NCT01706679|Drug|ATX-101 (10 mg/ml)|
16159590|NCT01706679|Drug|ATX-101 (20 mg/ml)|
16159591|NCT01706679|Drug|Moxifloxacin (400 mg)|
16159592|NCT01706679|Drug|Placebo vehicle (PBS)|
16159593|NCT01706666|Drug|bortezomib|Given SC
16159594|NCT01706666|Drug|cyclophosphamide|Given PO
16159595|NCT01706666|Drug|lenalidomide|Given PO
16159596|NCT01706666|Other|laboratory biomarker analysis|Correlative studies
16159597|NCT01706666|Drug|dexamethasone|Given PO
16159598|NCT01706666|Procedure|quality-of-life assessment|Ancillary studies
16159599|NCT01706653|Dietary Supplement|Polyphenol-enriched fruit-based drink - low|
16159600|NCT01706653|Dietary Supplement|Polyphenol-enriched fruit-based drink - medium|
16159601|NCT01706653|Dietary Supplement|Polyphenol-enriched fruit-based drink - high|
16159602|NCT01706653|Dietary Supplement|Very low polyphenol fruit based drink (control)|
16159603|NCT01706627|Drug|10 mg Melatonin|Active Comparator: Drug: Melatonin 10 mg
16159604|NCT01706627|Drug|20 mg Melatonin|Active Comparator: Drug: Melatonin 20 mg
16159605|NCT01706627|Drug|Matched placebo|Matched placebo (identical formulation and delivery, without active ingredient)
16159606|NCT01706588|Drug|Diclofenac sodium|One single diclofenac injection into the surgical area before surgery but as soon as the anaesthetic has taken effect.
16159607|NCT01706575|Drug|Pegylated Interferon (Peginterferon) Alfa-2a|Peginterferon alfa-2a 180 mcg, subcutaneously (SC) once weekly for 48 weeks.
16159608|NCT01706575|Drug|Nucleos(t)ide Analogues (NA)|Nucleos(t)ide analogues includes adefovir, entecavir, lamivudine or tenofovir.
16159609|NCT01706562|Drug|Itraconazole|Itraconazole intravenous (IV) 200 mg twice daily for 2 days, a total of 4 doses and then 200 mg once daily until clinically significant resolution of neutropenia.
16159610|NCT01706536|Drug|Placebo|EP-101 Placebo AM + EP-101 Placebo PM
16159611|NCT01706536|Drug|EP-101 12.5 mcg|EP-101 12.5 mcg AM + EP-101 12.5 mcg PM
16159612|NCT01706536|Drug|EP-101 25 mcg|EP-101 25 mcg AM + EP-101 25 mcg PM
16159613|NCT01706536|Drug|EP-101 50 mcg|EP-101 50 mcg AM + EP-101 50 mcg PM
16159614|NCT01706536|Drug|EP-101 100 mcg|EP-101 100 mcg AM + EP-101 100 mcg PM
16159615|NCT01706523|Drug|STX209 (arbaclofen)|Long-term, daily, orally-administered STX209
16159616|NCT01706510|Drug|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bid for 7 days ± 2 days
16159617|NCT01706510|Drug|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg Daily for 7 days ± 2 days
16159618|NCT01706497|Device|Cerebral tissue oxygen saturation monitoring, blinded|
16159619|NCT01706484|Drug|BNO 1016|comparison of different dosages of drug and placebo
16159620|NCT01706471|Drug|Everolimus + Low dose CsA +PD|Group A : Initiation of 5mg/kg bid Neoral dose and 720mg bid Myfortic and then adjusting Neoral targeting 150-200ng. After 1 month reduce Neoral dose as following table and Certican starting 0.75mg bid then adjust Certican 3-8ng/ml. Myfortic continue until Certican trough level goes up >3 ng/mL. Steroid dose follows local protocol.
16159621|NCT01706471|Drug|Myfortic+ Standard CsA + PD|Group B : Initiation of 5mg/kg bid Neoral dose and 720mg bid Myfortic and then adjusting Neoral targeting 150-200ng/ml. After 1 month reduce Neoral dose targeting 100-200ng with no change of Myfortic dose. Steroid dose follows local protocol.
16159622|NCT01706458|Biological|sipuleucel-T|Given IV
16159623|NCT01706458|Biological|DNA Vaccine|Given ID
16159624|NCT01706445|Other|Other|inspiratory muscle training (IMT) + aerobic and strength training 8-week duration IMT twice a day (mostly at home) + 3 weekly sessions of inhospital resistance + aerobic training
16159625|NCT01706432|Radiation|hyperfractionated radiation therapy|Undergo hypofractionated radiation therapy
16159626|NCT01706432|Other|laboratory biomarker analysis|Correlative studies
16159627|NCT01706432|Radiation|stereotactic radiosurgery|Undergo stereotactic radiosurgery
16159628|NCT01706419|Dietary Supplement|Fortified rice cold extruded kernel|
16159629|NCT01706419|Dietary Supplement|fortified rice warm extruded kernel|
16159630|NCT01706419|Dietary Supplement|fortiified rice hot extruded kernel|
16159631|NCT01706406|Behavioral|Brief psychoeducational intervention for female sexual arousal disorder|four 1.5 hour long group psychoeducational sessions, spaced 2 weeks apart for a total of 8 weeks.
16159632|NCT01706393|Dietary Supplement|probiotics (six probiotic cultures)|Effects of probiotics supplementation on intestinal microbiome; 2capsule bid orally for six weeks, 1capsule(500mg) Started eating probiotics one week prior of radiation therapy.
16159633|NCT01706393|Dietary Supplement|Placebo|Placebo intake for 6 weeks(including 5weeks of Rtx) and it take one tablet twice a day.
16159634|NCT01706380|Behavioral|Interactive voice response with personal feedback|Personal feedback is given at the end of each automated telephone follow-up call, and reports back to the patient whether his och her symptom status is better, worse or equal, compared to the previous telephone call.
16159635|NCT01706380|Behavioral|Interactive voice response without personal feedback|Control condition. Identical follow-up but without personal feedback.
16159636|NCT01706367|Biological|C. difficile vaccine|0.5 mL IM injection
16159637|NCT01706367|Biological|C. difficile vaccine +adjuvant|0.5 mL IM injection
16159638|NCT01706367|Biological|C. difficile vaccine|0.5 mL IM injection
16159639|NCT01706367|Biological|C. difficile vaccine +adjuvant|0.5 mL IM injection
16159640|NCT01706367|Biological|C. difficile vaccine|0.5 mL IM injection
16159641|NCT01706367|Biological|C. difficile vaccine +adjuvant|0.5 mL IM injection
16159642|NCT01706354|Procedure|Local Anaesthetic|Infiltration of local anaesthetic into the surgical site by the surgeon using a combination of 0.5% L-bupivicaine prior to incision and 1% lignocaine topically after the wound is opened. Maximum dose limits of 2mg/kg for bupivicaine, and 3mg/kg for lignocaine will be observed, recognising that these are additive.
16159643|NCT01706354|Procedure|Regional anaesthetic|Ultrasound guided brachial plexus block. Supraclavicular will be the block performed unless there is a contraindication in which case axillary block may be used. A 1:1 mixture of 0.5% L-bupivicaine and 1.5% lignocaine with adrenaline (1 in 200,000) will be injected, up to a volume of 40ml but using a minimum of 25ml. Maximum dose limits of 2mg for bupivicaine and 7mg/kg for lignocaine with adrenaline will be observed, recognising that these are additive.
16159644|NCT01706341|Drug|administer acetate Ringer's solution|During cesarean section under spinal anesthesia, each acetate Ringer's solution is administered before delivery.
16159645|NCT01706341|Drug|acetate Ringer's solution containing no glucose|
16159646|NCT01706341|Drug|acetate Ringer's solution containing 1% glucose|
16159723|NCT01705691|Drug|Paclitaxel|80 mg/m2 IV over 60 minutes weekly for 12 weeks
16159647|NCT01706328|Drug|FF/VI 100/25 Inhalation Powder NDPI|Subjects randomized to the FF/VI Inhalation Powder Novel Dry Powder Inhaler (NDPI) arm will receive a single inhalation of 100 mcg FF and 25 mcg VI via NDPI every morning for 12 weeks.
16159648|NCT01706328|Drug|Fluticasone Propionate/Salmeterol 250/50 Inhalation Powder ACCUHALER/DISKUS|Subjects randomized to the Fluticasone Propionate/Salmeterol Inhalation Powder ACCUHALER/DISKUS arm will receive a single inhalation of 250 mcg Fluticasone Propionate and 50 mcg Salmeterol via ACCUHALER/DISKUS once in the morning and once in the evening for 12 weeks.
16159649|NCT01706328|Drug|Placebo Inhalation Powder NDPI|Subjects randomized to the Fluticasone Propionate/Salmeterol Inhalation Powder ACCUHALER/DISKUS arm will receive a single inhalation of placebo inhalation powder via NDPI every morning for 12 weeks.
16159650|NCT01706328|Drug|Placebo Inhalation Powder ACCUHALER/DISKUS|Subjects randomized to the FF/VI Inhalation Powder NDPI arm will receive a single inhalation of placebo inhalation powder via ACCUHALER/DISKUS once in the morning and once in the evening for 12 weeks.
16159651|NCT01706328|Drug|Salbutamol as needed|Salbutamol inhalation powder
16159652|NCT01706315|Drug|GSK2140944|GSK2140944 will be available as immediate release capsules of dose strength 100 mg and 500 mg
16159653|NCT01706315|Drug|Placebo|Matching placebo will be available
16159654|NCT01706302|Other|Data collection|The previous study has used four primary data sources: the General Practice Research Data (GPRD [recently re-named Clinical Practice Research Datalink (CPRD)], for mild outcomes), the Hospital Episode Statistics database (HES, for hospitalizations), the Office of National Statistics mortality database (ONS, for mortality), and weekly virology data from the Health Protection Agency (HPA). The extracted data are referred to as the EPI-FLU-018 BOD UK DB database. Weekly time series will be generated to estimate the RSV burden and characterize it in terms of incidence of GP consultations, hospitalizations and deaths for each of the respiratory and non-respiratory outcomes (including GP antibiotic prescriptions), stratified by age and risk group.
16159655|NCT01706263|Drug|MAXCLARITY II (2.5% BPO) Foam Cleanser|Available over the counter.
16159656|NCT01706263|Drug|MAXCLARITY II (2.5% BPO) Foam Treatment|Available over the counter.
16159657|NCT01706263|Drug|MAXCLARITY II (0.5% Salicylic Acid) Toner Foam|Available over the counter.
16159658|NCT01706250|Other|MAXCLARITY II (2.5% BPO) Foam Cleanser|Available over the counter.
16159659|NCT01706250|Other|MAXCLARITY II (2.5% BPO) Foam Treatment|Available over the counter.
16159660|NCT01706250|Other|MAXCLARITY II (0.5% Salicylic Acid) Toner Foam|Available over the counter.
16159661|NCT01706250|Other|PROACTIV (2.5% BPO) Renewing Cleanser|Available over the counter.
16159662|NCT01706250|Other|PROACTIV (2.5% BPO) Repairing Lotion|Available over the counter.
16159663|NCT01706250|Other|PROACTIV (2.5% BPO) Revitalizing Toner|Available over the counter.
16159664|NCT01706237|Device|Nexisvision shield|A shield is placed on the eye after LASIK. The shield is similar to a contact lens.
16159665|NCT01706224|Procedure|Blood sample|Samples will be tested to determine the presence of anti-pertussis antibodies.
16159666|NCT01706224|Other|Data collection|Electronic Case Report Forms (eCRF)
16159667|NCT01706224|Other|Data collection|Questionnaires, active questioning.
16159668|NCT01706211|Drug|BRL 49653C|BRL 49653C 2 mg bid or placebo bid through weeks 1 to 24.
16159669|NCT01706211|Drug|Placebo|
16159670|NCT01706198|Drug|fluticasone furoate + vilanterol|once daily via a Novel Dry Powder Inhaler
16159671|NCT01706198|Drug|inhaled corticosteroid with or without a long acting beta2-agonist|ICS alone or in combination with a long acting bronchodilator
16159672|NCT01706185|Other|Data acquisition and analysis|Tumor tissue samples submitted for analysis together with a form containing clinical data previously collected and archived from patients with bladder cancer.
16159673|NCT01706172|Other|Injection of 20% dextrose/ 0.2% lidocaine|Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 20% dextrose and 0.2% lidocaine.
16159674|NCT01706172|Other|Injection of 1 ml of 0.8 Sterile water /0.2% lidocaine|Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 0.8 sterile water and 0.2% lidocaine
16159675|NCT01706159|Drug|catridecacog|Catridecacog (recombinant factor XIII, rFXIII) will be administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week at a dose of 35 IU/kg
16159676|NCT01706159|Drug|placebo|Placebo will be administered as intravenous (i.v.) injections (at an approximate rate of 1-2 mL/min) once every second week.
16159677|NCT01706146|Drug|Non-coumadin Oral Anticoagulant|Administration of Non-coumadin Oral Anticoagulant for 30 days following episode of atrial fibrillation as detected by the Reveal XT device.
16159678|NCT01706133|Other|Factors associated with the use of emergency departments|Participants who were assigned to the intervention will be evaluated jointly by the medical service by a medical specialist in geriatrics and a nurse trained in gerontology and geriatrics. The doctor will monitor the apparition and / or aggravation of any geriatric syndromes already established by the specialty in geriatrics, namely, polypharmacy, delirium, dementia, depression, risk of falls, etc.. The nurse will monitor and follow up in four areas I. medical issues (pressure ulcers, infusion, mobility); II. Mental and emotional state and coping strategies with hospitalization; III. functionality, and IV. Atmosphere (A. Service status, architectural difficulties for mobility, bathing etc. B. Support Network, caregiver, and C. hardship)
16159679|NCT01706120|Drug|Bevacizumab|• Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks up to 22 cycles
16159680|NCT01706120|Drug|Paclitaxel|• Bevacizumab 15 mg/kg i.v. on Day 1 every 3 weeks up to 6 cycles
16159681|NCT01706120|Drug|Carboplatin|• Carboplatin (AUC 5) on Day 1 every 3 weeks for up to 6 cycles
16159682|NCT01706094|Other|Head Position|"Head position during the first 48 hours from admission of patients with acute ischemic stroke.
~This trial is organized as a cluster randomised trial to a policy of flat head position or upright head position. Clusters will be months, so that all patients admitted during a given month will be positioned either in the flat down head position (intervention) or upright head position (control). This will allow health teams to follow a monthly protocol without changing position between patients."
16159683|NCT01706081|Procedure|Acupuncture|Each treatment will be 30 minutes in duration. Patients will receive two acupuncture treatments each week for six consecutive weeks. Patients will be advised to continue their standard lymphedema treatments such as exercise or use of compression garments if these were in use prior to clinical trial participation.
16175944|NCT01577823|Device|Foley Catheter|
16159684|NCT01706081|Procedure|Wait-list|For participants in the wait-list control group, follow-up objective and subjective assessments of lymphedema will be performed after approximately 6 weeks on the wait-list, before onset of acupuncture treatment, following 6 weeks of acupuncture treatment and about 3 months after completion of treatment. BMI will be measured at the same timepoints.
16159685|NCT01706055|Biological|Interferon beta-1b (Betaseron, BAY86-5046)|Subcutaneous injections of Betaferon 250 mcg every other day according to Product Characteristic.
16159686|NCT01706042|Other|legume meal|
16159687|NCT01706042|Other|white bread|
16159688|NCT01706016|Procedure|Thermic destruction of tissue by Laser using the Novilase device|
16159689|NCT01705990|Biological|SeV-G(NP) (0.2mL, 2x10^7 CIU)|Delivered intranasally by drops
16159690|NCT01705990|Biological|SeV-G(NP) (0.2mL, 2x10^8 CIU)|Delivered intranasally by drops
16159691|NCT01705990|Biological|Ad35-GRIN (0.5mL)|(1x10^10 vp) Delivered intramuscularly by standard syringe and needle injection
16159692|NCT01705977|Biological|Placebo plus standard therapy|Placebo plus standard therapy
16159693|NCT01705977|Biological|Belimumab 10 mg/kg plus standard therapy|Belimumab 10 mg/kg plus standard therapy
16159694|NCT01705977|Other|Standard therapy|Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; other biologics are not permitted.
16159695|NCT01705964|Drug|IM epinephrine 1:1000|IM epinephrine 1:1000. The dose will be 0.2 mg for subjects 20-30 kg and 0.3 mg for subjects greater than 30 kg. This will be injected intramuscularly by an ED nurse into the anterior thigh muscles of the subject using a 1 ml syringe and a 23 gauge one inch needle.
16159696|NCT01705964|Other|No intervention|A sham band-aid will be applied to the anterior thigh of subjects who are randomized to the no intervention group.
16159697|NCT01705951|Other|Resistance Training (RT)|Resistance Training program 3x/week at 60 minutes per session for 12 weeks.
16159698|NCT01705951|Biological|Nicotine Replacement Therapy (NRT)|Nicotine patch for 12 weeks (21mg, 14mg, 7mg.) and referral to California Smoker's Helpline for 6 sessions of smoking cessation counseling.
16159699|NCT01705938|Drug|SP-333|
16159700|NCT01705912|Other|Complete intervention|The basic intervention, an occupational therapist assessed the home environment and gave advice, if necessary. Then participants were assessed by a physiotherapist concerning health and function pre and post intervention. The intervention consisted of an individually designed home exercise program aiming at improving balance, muscle strength and walking ability. The program, which was made by the physiotherapist, should be performed three times a week. A minimum of 30 minutes of walking per week was recommended, encouring further walking on an individual basis. An assistant nurse made eight home visits to supervise, help and encourage performance of activities.
16159701|NCT01705912|Other|Basic intervention|The basic interventions was an occupational therapist assessed the home environment and gave advice, if necessary. Then participants were assessed by a physiotherapist concerning health and function pre and post intervention.
16159702|NCT01705899|Drug|Human Pancreatic Islets|Pancreatic islet tissue suspended in 150 - 300 ml of phenol red-free CMRL-1066 Transplant Media supplemented with 4% (w/v) HSA and 16mM HEPES in a 600ml transfer pack. Heparin will be administered at 70 IU/kg recipient body weight. Administered by intra-portal vein infusion. To be administered once, however, if full graft function is not achieved, a second or third dose of Pancreatic Islets may be given within 18 months of the first transplant.
16159703|NCT01705886|Procedure|Total Knee Arthroplasty|Patients undergoing manual (no robot used) surgery to replace of all 3 compartments of the knee
16159704|NCT01705886|Procedure|MAKO® Robot Assisted Medial Knee Arthroplasty|Patients undergoing a MAKO® robot assisted surgery to replace the medial compartment of the knee
16159705|NCT01705886|Device|RESTORIS Multicompartmental Knee System|The RESTORIS Multicompartmental Knee (MCK) System components are intended for single or multicompartmental knee replacement used in conjunction with the MAKO® Robotic Arm Interactive Orthopedic System (RIO®). The components can be used for medial compartment, lateral compartment, patellofemoral compartment, or bicompartmental (medial and patellofemoral compartments) knee replacement. The device is intended to be used with bone cement.
16159706|NCT01705886|Device|Depuy Knee Replacement System|The Depuy Knee Replacement System components are intended for use in total knee replacement. These components are intended for implantation with bone cement.
16159707|NCT01705886|Device|Stryker® Knee Replacement System|The Stryker® Knee Replacement System components are intended for use in total knee replacement. These components are intended for implantation with bone cement.
16159708|NCT01705860|Biological|Santyl|
16159709|NCT01705847|Drug|GS-9820|GS-9820 tablets containing 200 mg of GS-9820 administered orally
16159710|NCT01705821|Device|Use of force sensing surgical curette|Use of a standard surgical curette outfitted with an in-line 6-axis force and torque transducer for collection of force data during surgery.
16159711|NCT01705821|Procedure|Removal of pituitary tumor using modified curette|
16159712|NCT01705808|Drug|Protein C concentrate|
16159713|NCT01705795|Drug|Mepolizumab (a-IL-5 antibody)|750mg mepolizumab four times over four months
16159714|NCT01705795|Drug|Placebo|Nacl four times over four months
16159715|NCT01705782|Biological|E. coli endotoxin, US standard|
16159716|NCT01705769|Other|Ready to Use Therapeutic Food-Centrally produced|Ready to Use Therapeutic Food-Centrally produced by an Indian company.
16159717|NCT01705769|Other|Ready to Use Therapeutic Food-Locally produced|Ready to Use Therapeutic Food prepared by the study team
16159718|NCT01705769|Other|High energy and micronutrient rich foods|High energy and micronutrient rich foods prepared by caregivers at home using ingredients provided to them
16159719|NCT01705756|Drug|Kineret|Patients randomized to active drug will receive Kineret(Anakinra), 100 mg prefilled syringes for subcutaneous injection, once a day for 4 months. The syringes will arrive relabeled from the supplier (SOBI) to Sheba Medical Center. They will be stored at the PI's store room in a temperature controlled refrigerator.
16159720|NCT01705743|Drug|Sevoflurane+Nitrous oxide|60% nitrous oxide +40% oxygen+ Sevoflurane
16159721|NCT01705743|Drug|Sevoflurane|100% oxygen+ Sevoflurane
16159722|NCT01705730|Drug|tocilizumab|Participants received tocilizumab monotherapy according to individualized physician-prescribed regimens.
16161458|NCT01692015|Other|Questionnaire on dietary history|
16159724|NCT01705691|Drug|Eribulin|1.4 mg/m2 IV over 2 to 5 minutes on Days 1 and 8 every 21 days for 4 cycles
16159725|NCT01705691|Drug|Doxorubicin|60 mg/m2 IV over 15 minutes on day 1 every 21 days for 4 cycles
16159726|NCT01705691|Drug|Cyclophosphamide|600 mg/m2 IV over 30 minutes on day 1 every 21 days for 4 cycles
16159727|NCT01705678|Dietary Supplement|Krill oil|Krill oil 300 mg DHA/EPA daily for 6 weeks
16159728|NCT01705678|Dietary Supplement|Fish oil|Fish oil 500 mg DHA/EPA daily for 6 weeks
16159729|NCT01705652|Drug|Nexrutine|Nexrutine 500mg by mouth, three times per day, given prior to surgery or prior to and during radiation treatment.
16159730|NCT01705639|Drug|Melatonin|All subjects receive the same dose of melatonin
16159731|NCT01705600|Behavioral|Pain Verbalization Repression Rules|The involved subjects will be randomized to either a bracelet with receive verbal repression guidelines OR just a bracelet. They will receive typical physical therapy interventions for the treatment of low back pain (modalities, exercise, manual treatment) with the only change being the education of the one group to repress verblization of pain complaints. The bracelet is worn as a reminder of the rules given.
16159732|NCT01705587|Drug|teriparatide|20 microgram once-daily subcutaneous injection
16159733|NCT01705574|Drug|E/C/F/TDF|150/150/200/300 mg FDC tablet administered orally with food once daily
16159734|NCT01705574|Drug|ATV|300 mg capsule administered orally with food once daily
16159735|NCT01705574|Drug|RTV|100 mg tablet administered orally with food once daily
16159736|NCT01705574|Drug|FTC/TDF|200/300 mg tablet administered orally with food once daily
16159737|NCT01705574|Drug|E/C/F/TDF Placebo|Tablet administered orally with food once daily
16159738|NCT01705574|Drug|ATV Placebo|Tablet administered orally with food once daily
16159739|NCT01705574|Drug|RTV Placebo|Capsule administered orally with food once daily
16159740|NCT01705574|Drug|FTC/TDF Placebo|Tablet administered orally with food once daily
16159741|NCT01705574|Drug|E/C/F/TAF|150/150/200/10 mg FDC tablet administered orally with food once daily
16159742|NCT01705548|Radiation|Hypofractionated Radiosurgery|Radiation Therapy will consist of partial brain irradiation delivered to the metastatic brain tumor or resection cavity, delivered in 5 treatments with 2-3 treatments delivered per week.
16159743|NCT01705535|Behavioral|Individual supervised pelvic floor muscle exercises|Six individual treatments of 45 minutes by a physiotherapist specialized in pelvic floor disorders. Preparation of an individual adapted training program for the pelvic floor muscles. Encouragement to perform the pelvic floor muscle training program on a daily basis
16159744|NCT01705535|Other|Massage of the neck and back|six individual treatments of 30 minutes by a physiotherapist. The participants will get no instructions of pelvic floor muscle exercises.
16159745|NCT01705535|Behavioral|Standard information and guidance|Advice about diet and fiber supplements. Information about optimizing bowel emptying including use of medicine. Advice about use of antidiarrheal medication if appropriate.
16159746|NCT01705509|Drug|Ranolazine|The intervention will be ranolazine therapy after the initial CPET. The initial CPET will identify patients with underlying ischemia and serve as a baseline study. Patients whose CPET results meet the criteria for ischemia will be started on Ranexa 500mg BID and advanced within one week +/-4 days to 1000mg BID. A second CPET will be performed after 4 weeks +/- 4 days of maximum therapy. CPET results before and after therapy will undergo a statistical comparison. The initial off treatment CPET measurement will serve as the control to assess changes found during therapy.
16159747|NCT01705496|Radiation|[124I]FIAU|This is a single dose study of 5 mCi [124I]FIAU in subjects presenting with pain in a prosthetic knee or hip joint. Subject will receive two PET-CT scans after [124I]FIAU injection.
16159748|NCT01705483|Drug|ASP9853|oral
16159749|NCT01705483|Drug|Docetaxel|intravenous (IV)
16159750|NCT01705483|Drug|Paclitaxel|Taxol
16159751|NCT01705470|Drug|furosemide|
16159752|NCT01705470|Drug|placebo normal saline|
16159753|NCT01705457|Drug|Dietary Supplement: vitamin A|"25000 IU/day vitamin A for 6 months
~1 Cap/Day
~1 cap placebo/day for 6 month"
16159754|NCT01705457|Drug|placebo|
16159755|NCT01705444|Device|Foley Catheter and The Spanner Insertion|A Foley catheter will be inserted for 3-5 days, then a voiding trail will be attempted by the patient himself without the catheter. Then, the Spanner will be inserted into the same patient for another 3-5 days and an evacuation trail will be attempted also by the patient after removal of the Spanner. Treatment Satisfaction Questionnaire (TSQ) will be applied by the same person to the patient twice, once after removal of the Foley catheter and the second after removal of the Spanner.
16159756|NCT01705431|Behavioral|On Track|The purpose of the On Track intervention is to address a need raised by a day-treatment school in Lane County: Support for students transitioning from the day-treatment school (Lane School) to their district middle schools. Eligible students are currently attending Lane School, in middle school (Grades 6-8), with or at risk for Emotional Disturbance, and are preparing to transition to their district schools.
16159757|NCT01705405|Device|Software for acquiring ultrasound and endoscopic images|Use of a medical device to acquire ultrasound and endoscopic images
16159758|NCT01705392|Drug|Bevacizumab|Bevacizumab 10 mg/kg q3w
16159759|NCT01705392|Drug|Propranolol|Propranolol 80 mg x 1
16159760|NCT01705392|Drug|Enalapril|Enalapril 5 mg x 1
16159761|NCT01705392|Drug|Dacarbazine|dacarbazine 1000 mg/m2 q3w
16159762|NCT01705379|Biological|Novartis Meningococcal ACWY Conjugate Vaccine|Immunization
16159763|NCT01705366|Procedure|Non-MAKO® Robot Assisted Total Knee Arthroplasty|Patients undergoing a non-MAKO® robot assisted surgery to replace one or more compartments of the knee.
16159764|NCT01705366|Procedure|MAKO® Robot Assisted Medial Knee Arthroplasty|Patients undergoing a MAKO® robot assisted surgery to replace the medial compartment of the knee.
16159765|NCT01705366|Procedure|MAKO® Robot Assisted Medial and PF Knee Arthroplasty|Patients undergoing a MAKO® robot assisted surgery to replace the medial and patellofemoral (PF) compartments of the knee
16159766|NCT01705366|Device|RESTORIS Multicompartmental Knee System|The RESTORIS Multicompartmental Knee (MCK) System components are intended for single or multicompartmental knee replacement used in conjunction with the MAKO® Robotic Arm Interactive Orthopedic System (RIO®). The components can be used for medial compartment, lateral compartment, patellofemoral compartment, or bicompartmental (medial and patellofemoral compartments) knee replacement. The device is intended to be used with bone cement.
16159767|NCT01705366|Device|Depuy Knee Replacement System|The Depuy Knee Replacement System components are intended for use in total knee replacement. These components are intended for implantation with bone cement.
16159768|NCT01705366|Device|Stryker® Knee Replacement System|The Stryker® Knee Replacement System components are intended for use in total knee replacement. These components are intended for implantation with bone cement.
16159769|NCT01705340|Drug|Akt inhibitor MK2206|Given PO
16159770|NCT01705340|Biological|trastuzumab|Given IV
16159771|NCT01705340|Drug|lapatinib ditosylate|Given PO
16159772|NCT01705340|Other|laboratory biomarker analysis|Optional correlative studies
16159773|NCT01705314|Dietary Supplement|vitamin D supplements|Participants will receive 7mls of D-drops (14,000U/week of vitamin D)
16159774|NCT01705314|Dietary Supplement|placebo|7mls of placebo drops per week for 8 months.
16159775|NCT01705301|Device|WINCS|The experimental protocol will involve, after implantation of the DBS electrodes, the patient will have a single electrochemical recording electrode will be implanted along the same trajectory path as the electrophysiology and the DBS electrode
16159776|NCT01705288|Procedure|Laparotomy|Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital
16159777|NCT01705288|Drug|intravenous narcotics|given for pain management after surgery per physician orders
16159778|NCT01705288|Drug|standard anesthesia|inhalant or intravenous during surgery
16159779|NCT01705288|Drug|regional anesthesia|given by spinal or epidural infusion
16159780|NCT01705288|Drug|Non-steroidal anti-inflammatory drugs|given for pain management after surgery
16159781|NCT01705275|Drug|ONO-8539|ONO-8539
16159782|NCT01705275|Other|Placebo|Identical to ONO-8539 tablet but without active ingedient
16159783|NCT01705249|Drug|1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)|After a screening period of 12 weeks (three lunar months) in which the subjects still are on Trisekvens® followed by a treatment period of 24 weeks (six lunar months) in which the subjects are treated with Activelle®.
16159784|NCT01705236|Drug|Fingolimod|All subjects received an oral dose of 0.5 mg fingolimod (FTY720) per capsule (hard gelatin capsules) once daily according to local label for the treatment of their MS.
16159785|NCT01705223|Biological|DNA vaccine|4mg/dose, three doses at week 0,4,8
16159786|NCT01705223|Biological|DNA vaccine prime with the addition of electroporation|4mg/dose, three doses at week 0,4,8
16159787|NCT01705223|Biological|rTV boost|at week 16
16159788|NCT01705223|Biological|rTV boost|at week 24
16159789|NCT01705223|Biological|rTV boost|at week 32
16159790|NCT01705197|Drug|Avanafil 100 or 200mg|This study is designed as a double-blind, stratified randomized, placebo controlled, parallel group, multicenter, dose escalation study. For subjects with moderate to severe ED who have voluntarily signed the consent form, conduct screening and undertake the 4 weeks Free run-in period. For those who satisfy the study criteria during the review of subject's diaries composed during the free run-in period and the evaluation of inclusion/exclusion criteria at a future visit, drugs for each group are provided after randomized to Avanafil 100mg or placebo 100mg at a ratio of 2:1. At this time, subjects are random stratified to each group depending on their diabetes status.
16159791|NCT01705184|Drug|Cisplatin|75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. During 3 cycles of each sequence
16159792|NCT01705184|Drug|Bevacizumab|7,5 mg/kg, IV (in the vein) on day 1 of each 21 day cycle until progression for each sequence
16159793|NCT01705184|Drug|Pemetrexed|500 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. During 3 cycles for the 1st sequence and until progression for the 2nd sequence.
16159794|NCT01705158|Drug|carboplatin and liposomal doxorubicin|Carboplatin AUC5 and liposomal doxorubicin 40 or 50 mg/m2, IV (in the vein) on day 1 of each 28 day cycle. Number of Cycles: 6 or until progression or unacceptable toxicity develops.
16159795|NCT01705145|Drug|Ivacaftor|
16159796|NCT01705119|Other|Standing|
16159797|NCT01705106|Drug|capecitabine|Given PO
16159798|NCT01705106|Drug|celecoxib|Given PO
16159799|NCT01705106|Other|pharmacological study|Correlative studies
16159800|NCT01705106|Other|laboratory biomarker analysis|Correlative studies
16159801|NCT01705106|Other|pharmacogenomic studies|Correlative studies
16159802|NCT01705093|Dietary Supplement|flavonoid-rich freeze-dried strawberry powder|50g of flavonoid-rich freeze-dried strawberry powder
16159803|NCT01705093|Dietary Supplement|macronutrient-matched control powder|50g macronutrient-matched powder that will lack strawberry flavonoids
16159804|NCT01705080|Device|EnligHTN|Renal artery ablation with EnligHTN system used for all groups
16159805|NCT01705067|Device|TKA with Journey II BCS Total Knee System|TKA with Journey II BCS Total Knee System
16159806|NCT01705041|Device|Diagnostics for All liver function test (LFT)|HIV clinic patients meeting targeted enrollment criteria will give fingerstick blood for use on investigational LFT in comparison to routine transaminase test performed at the clinic lab (gold standard)
16159807|NCT01705015|Behavioral|direct feedback about exercise|
16159808|NCT01705015|Behavioral|PLacebo|UCFit plus encouraged exercise
16159809|NCT01705002|Drug|Promitil|2 mg/kg dose IV
16159810|NCT01705002|Drug|Capecitabine|1000 mg dose BID PO for days 1-21 for Combination Cohort and on day 1-14 on Triple combination Cohort
16159811|NCT01705002|Drug|Bevacizumab|for Triple combination cohort an IV dose of 5 mg/kg on day 1 at 4 week interval. For the 3 weekly cohort an IV dose of 7.5 mg/kg at 3 week interval.
16159812|NCT01704989|Procedure|SLT Laser|At the first treatment, SLT treatment will be delivered to 360 degrees of trabecular meshwork. At the first escalation of treatment, the superior 180 degrees will be retreated. Twenty-five non-overlapping shots per quadrant will be used with a starting power of 0.8 mJ and increments of 0.1 mJ (titrated to avoid large bubbles) with standard other settings (400 nm spot size, 3 nanosecond duration) using a Latina single-mirror goniolens. The IOP will be checked 1 hour post treatment and five days of guttae acular tds will be administered to the treatment eye following treatment. After 2 treatments of SLT, the laser treated arm of the study will follow the same pathway as the medical treatment arm.
16159854|NCT01704729|Procedure|group4|Cycloplegic subjective refraction by an experienced optometrist +ready-made glasses
16178582|NCT01557777|Drug|Navitoclax|QD
16159813|NCT01704989|Drug|Prostagladin|Treatment will be initiated with latanoprost 0.005%. At the first IOP check (1-2 months), if the IOP has not reached target IOP, a second line agent will be added (β-Blocker unless contraindicated). If target IOP is still not reached, a third agent will be considered (topical carbonic anhydrase inhibitor). Treatment may be switched, instead, at the discretion of the clinician if the reduction of IOP with an agent is deemed to be no different than the pre-treatment IOP. Surgical therapy will be considered if target IOP is not met, or there is high IOP (>35 mmHg) or advanced damage at presentation.
16159814|NCT01704976|Device|SR-WBV|Participants will undergo a training program set over four weeks, three times a week with 3 to 6 Hz, Noise 4.
16159815|NCT01704976|Device|SR-WBV|Participants will undergo a training program set over four weeks three times a week with 1 Hz, Noise 1.
16159816|NCT01704963|Drug|PCI-32765|PCI-32765 will be administered in Cohort 1, Cohort 2 and CLL/SLL Cohort. In Cohort 1, single oral dose of PCI-32765 140 mg and 280 mg will be administered before daily oral doses of 420 mg per day for 35 days in Cycle 1 and for 28 days in Cycle 2 and thereafter. In Cohort 2 and CLL/SLL Cohort, PCI-32765 560 mg and 420 mg per day, respectively will be administered daily for 35 days in Cycle 1 and for 28 days in Cycle 2 and thereafter.
16159817|NCT01704937|Drug|Fecal Microbiota Transplant (FMT)|"Reconstitution of normal flora by a stool transplant from a healthy individual to a C. difficile - infected recipient via colonoscopy or nasogastric tube"
16159818|NCT01704924|Device|Prevena|Device will be applied at end of procedure over closed incision
16159819|NCT01704924|Procedure|Standard of Care Dressing|Dressing applied as Standard of Care
16159820|NCT01704911|Procedure|Transradial Coronary Intervention|
16159821|NCT01704911|Procedure|Transfemoral Coronary Intervention|
16159822|NCT01704911|Device|Coronary Stent System|Any kind of coronary stent system
16159823|NCT01704898|Drug|Efavirenz 600 Test-Stocrin 600 Reference|
16159824|NCT01704898|Drug|Stocrin 600 Reference-Efavirenz 600 Test|
16159825|NCT01704885|Behavioral|Play Intervention|
16159826|NCT01704885|Other|Questionnaires|
16159827|NCT01704872|Drug|ch14.18/CHO|
16159828|NCT01704859|Dietary Supplement|Vitamin D3 placebo|Vitamin D placebo
16159829|NCT01704859|Dietary Supplement|Fish oil placebo|Fish oil placebo
16159830|NCT01704859|Drug|omega-3 fatty acids (fish oil)|Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
16159831|NCT01704859|Dietary Supplement|Vitamin D3|Vitamin D3 (cholecalciferol), 2000 IU per day.
16159832|NCT01704846|Drug|BI 201335 NA 120 mg capsule|1capsule of BI 201335 NA 120 mg capsule
16159833|NCT01704846|Drug|BI 201335 NA 120 mg capsule|1 capsule of BI 201335 NA 120 mg capsule
16159834|NCT01704846|Drug|BI 201335 NA 40 mg capsule|3 capsules of BI 201335 NA 40 mg capsule
16159835|NCT01704846|Drug|BI 201335 NA 40 mg capsule|3 capsules of BI 201335 NA 40 mg capsule
16159836|NCT01704833|Behavioral|Paranoia-Focused Cognitive Behavioral Therapy (PFCBT)|The PFCBT is a 15-week Program that includes weekly group and individual sessions.
16159837|NCT01704820|Procedure|Retroflexion in the right colon|
16159838|NCT01704807|Device|foot orthotics|Experimental wore experimental orthotics throughout the study period as much of the day as possible.
16159839|NCT01704807|Device|Sham foot orthotic|Control group wore sham insoles as much of the time as possible for the duration of the study period.
16159840|NCT01704794|Dietary Supplement|Folic Acid + Paludrine + Jobelyn (500mg)|Combination of routine drugs + Jobelyn
16159841|NCT01704794|Drug|Folic Acid + Paludrine + Jobelyn (250mg)|Standard routine drugs for treatment of SCD with 250mg Jobelyn
16159842|NCT01704794|Dietary Supplement|Folic Acid + Paludrine + Jobelyn (2mg)|Combination of Paludrine + Folic Acid and Jobelyn 2mg (Sorghum bicolor extract)
16159843|NCT01704781|Drug|Lenalidomide|In Part A a dose escalation design is used (2,5; 5; 10; 25 mg). Part B will use the dose confirmed by Part A
16159844|NCT01704781|Drug|Lenalidomide placebo|Capsules are identical to the active Lenalidomide capsules used.
16159845|NCT01704781|Drug|Vacc-4X|Vacc-4x is a peptide-based HIV immunotherapy administered intradermally. Vacc-4x peptides are reconstituted in sterile water.
16159846|NCT01704781|Drug|rhuGM-CSF|Granulocyte macrophage colony stimulating factor as a local adjuvant
16159847|NCT01704768|Behavioral|COPE/Healthy Lifestyles TEEN Program.|The COPE Program is the intervention curriculum delivered to one arm of the study. Each session of COPE contains 15 to 20 minutes of physical activity (e.g., walking, dancing), not as an exercise training program, but rather to build beliefs/confidence in the teens that they can engage in and sustain some level of physical activity on a regular basis. Those healthy lifestyle intervention programs that have employed exercise interventions only have not led to sustained changes in healthy lifestyle behaviors. Our program is designed to enhance healthy lifestyle behaviors and sustain them because life-long cognitive-behavioral skills are taught in the program. Because the COPE TEEN program is completely manualized for the teens and instructors, it can be easily implemented by health teachers in high school settings.
16159848|NCT01704768|Behavioral|Healthy Teens Attention Control Program|The Healthy Teens program is an attention control program that will assist in ruling out alternative explanations of the mechanism by which the intervention works. It will be standardized like the COPE program to insure that it can be evaluated. It will be administered in a format like that of the COPE intervention program, and will include the same number and length of sessions, except for that it will not include the theoretical active components of CBT and will not include theoretical mechanisms to produce our hypothesized changes in outcomes. Teens in the attention control group also will receive the sessions in their required health class. The difference between the two programs will lie in the content of the sessions, with the Healthy Teens program being focused on safety and common health topics/issues for teens (e.g., road safety, skin care, acne, sun safety).
16159849|NCT01704755|Drug|ABT-450/r/ABT-267, ABT-333|Tablet; ABT-450 coformulated with ritonavir and ABT-267; ABT-333 tablet
16159850|NCT01704755|Drug|Ribavirin (RBV)|Capsule
16159851|NCT01704729|Procedure|group1|Non-cycloplegic self-refraction +conventional glasses
16159852|NCT01704729|Procedure|group2|Cycloplegic subjective refraction by experienced optometrist +conventional glasses
16159853|NCT01704729|Procedure|group3|Cycloplegic subjective refraction by Rural Refractionist Program + conventional glasses
16159928|NCT01704274|Other|Placebo|Placebo
16159855|NCT01704716|Drug|Vincristine|given during Rapid COJEC and modified N7 therapy
16159856|NCT01704716|Drug|Aldesleukin|Aldesleukin is given during MRD Treatment for patients randomised to the arm with IL-2
16159857|NCT01704716|Drug|ch14.18/CHO|ch14.18/CHO antibody is given during MRD treatment
16159858|NCT01704716|Drug|Carboplatin|Carboplatin is given during induction Treatment (R3 randomisation: Rapid COJEC arm)
16159859|NCT01704716|Drug|Etoposide|Etoposide is given during Induction Treatment (both R3 randomisation arms)
16159860|NCT01704716|Drug|Cisplatin|Cisplatin is given during Induction Treatment (both R3 randomisation arms)
16159861|NCT01704716|Drug|Cyclophosphamide|Cyclophosphamid is given during Induction Treatment (both R3 randomisation arms)
16159862|NCT01704716|Drug|Doxorubicin|Doxorubicin is given during Induction Treatment (R3 arm modified N7)
16159863|NCT01704716|Drug|G-CSF|G-CSF is given during Induction Treatment
16159864|NCT01704716|Drug|Busulfan|In case i.v. busulfan is not available, the use of oral busulfan is permitted, although not recommended.
16159865|NCT01704716|Drug|Melphalan|Melphalan is given during MAT treatment
16159866|NCT01704703|Drug|panitumumab|Panitumumab 6,0 mg/kg day 1 i.v. 60 min
16159867|NCT01704703|Drug|FOLFIRI|Irinotecan 180 mg/m2 day 1 i.v. 30-90 min Folinic acid 400 mg/ m2 day 1 i.v. 120 min 5-FU 400 mg/ m2 day 1 Bolus 5-FU 2.400 mg/ m2 day 1 i.v. 46 hours
16159868|NCT01704690|Drug|S-1 and Paclitaxel|S-1 and Paclitaxel are used in the S-1 and Paclitaxel arm.
16159869|NCT01704690|Drug|Paclitaxel and Cisplatin|The paclitaxel and cisplatin combination will be used in the Paclitaxel and Cisplatin arm.
16159870|NCT01704690|Drug|5-FU and Cisplatin|The cisplatin and 5-fluorouracil combination will be used in the Cisplatin and 5-FU arm.
16159871|NCT01704677|Procedure|Lumbar total disc replacement|The surgical intervention consisted of replacement of the degenerative intervertebral lumbar disc with a artificial lumbar disc device in one or two of the lover lumbal levels (L4/L5 or/and L5/S1). The ProDisc consists of three pieces, two metal endplates and a polyethylene core that is fixed to the inferior endplate when the device is implanted, and is implanted through a retroperitoneal (or transperitoneal) access.
16159872|NCT01704677|Behavioral|Multidisciplinary rehabilitation|The intervention is based on a treatment model described by Brox et al (Spine 2003;28:1913-1921) and is also described in details by Hellum et al (BMJ, May 2011). It consisted of a cognitive approach and supervised physical exercise and was delivered by a team of physiotherapists and specialists in physical medicine and rehabilitation. The rehabilitation programme lasted for about 60 hours over three to five weeks.
16159873|NCT01704664|Dietary Supplement|Early postoperative enteral nutrition, based on standard elementary diet (Peptisorb)|Early postoperative enteral nutrition with standard elementary diet (Peptisorb), will start 20 hours post-surgery. The initial flow rate will be 8 ml/h, which will increase gradually, with the volume doubled every 24 hours, up to 100 ml/h. The enteral nutrition wil be continued for six days. During the initial five days post-surgery, the patients will be additionally supplemented parenterally via peripheral veins (commercially available two-chamber bag for peripheral access with 480 kcal of energetic value and 5.7g of N contained in standard amino acids).
16159874|NCT01704664|Drug|glutamine|The nutritional therapy of group II patients will start post-surgery. It will be based on early enteral nutrition with elementary diet (Peptisorb) with simultaneous parenteral nutrition with two-chamber bag with 480 kcal energetic value and 5.7g of N contained in standard amino acids administered via peripheral veins. Additionally, glutamine (100 ml of Dipeptiven) will be added to the two-chamber bag. The parenteral nutrition will be administered for five days.
16159875|NCT01704664|Dietary Supplement|oral diet enriched with arginine (Cubitan)|Preoperatively, group III patients will be given commercially available oral diet enriched with arginine (Cubitan, 1 package 3 times per day). Additionally, they were administered commercially available two-chamber bag with 480 kcal energetic value and 5.7g of N in standard amino acids via peripheral access. The duration of pre-operative preparatory phase ranged between 5 and 10 days (8 days on average). Enteral nutrition with commercially available arginine-containing diet (Cubison) will start 20 hours post-surgery at an 8 ml/h flow rate; the rate will increase gradually, with the volume doubled every 24 hours, up to 100 ml/h and continued for six days. Simultaneously, commercially available two-chamber bags for peripheral access with composition identical to that used preoperatively will be administered via peripheral veins for five days.
16159876|NCT01704664|Drug|Perioperative parenteral immunonutrition (Dipeptiven, Omegaven)|Nutritional therapy of group IV will based on intravenous preparations. Two-chamber bags with 480 kcal energetic value and 5.7 g of N in standard amino acids were administered preoperatively. A solution of glutamine (Dipeptiven, 100 ml) and ω3-fatty acids (Omegaven, 100 ml) will be added to the bags. The duration of pre-operative preparatory phase ranged between 5 and 10 days (8 days on average). Enteral nutrition with elementary commercially available diet (Peptisorb) will be begun 20 hours post-surgery; it will start at an 8 ml/h flow rate and increased gradually, with the volume doubled every 24 hours, up to 100 ml/h. The enteral nutrition was continued for six days. During the initial five days post-surgery, the patients will be additionally supplemented parenterally via peripheral veins; similarly to the preoperative period, the content of two-chamber bag for peripheral access enriched with glutamine and ω3-fatty acids will be administered for five days.
16159877|NCT01704651|Drug|Alvimopan|Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative.
16159878|NCT01704651|Drug|Placebo|Perioperative administration of placebo, at same dosing interval as study drug.
16159879|NCT01704638|Drug|fluvoxamine|
16159880|NCT01704638|Drug|Digoxin|
16159881|NCT01704625|Procedure|Osteopathic Manipulative Treatment|The investigators wish to see if emergency medicine physicians can use osteopathic evaluation and OMT to reliably treat headaches. The results of the examination and treatment will be recorded, but will not be used to change treatment or to change additional tests.
16159882|NCT01704625|Procedure|Sham Osteopathic Manipulative Treatment|The sham group will receive 3 sham treatments.
16159883|NCT01704612|Drug|ropivacaine|patients received 20 mL ropivacaine 5 mg/mL on subgluteal nerve
16159884|NCT01704599|Drug|Humira Then Humira plus 3 B vitamins|Humira alone for 16 weeks then Humira plus 100 mg daily pyridoxine, 5 mg daily folic acid and 1000 mcg daily cyanocobalamin
16159885|NCT01704586|Radiation|Radioiodine I-131|Radioiodine will be used for ablation therapy, dosimetry and posttherapeutic whole body scan, as well as low dose I-131 imaging.
16186810|NCT01495715|Drug|Placebo|
16159886|NCT01704586|Radiation|I-124|I-124 will be used for imaging to assess uptake inside and outside of thyroid bed, using PET/CT whole body scanning, followed by I-131 therapy as necessary as per protocol.
16159887|NCT01704573|Drug|2-[18F]-fluro-3-[2(S)-2-azethidinylmethoxy]-pyridine|"The study will be performed using an Investigational New Drug (IND) Application for the 2-[18F]FA radioligand. The 2-[18F]FA radiotracer allows us to measure nicotine receptors. The PET imaging technique used at these sessions allows us to measure the amount of light that 2-[18F]FA gives off in different regions of the brain, we can estimate how many nicotine receptors are in that region.
~2-[18F]FA (radiotracer) is investigational, which means it is not approved by the United States Food and Drug Administration (FDA) for the way that it is being used in this research study. For this reason, we have received approval for all procedures in the current study including the use of 2-[18F]FA from the FDA."
16159888|NCT01704560|Other|Coversheet to Informed Consent|The intervention is a one page cover sheet to be affixed to the front of the standard permission form for the trial for which permission is being sought (attached to application). The form will identify the study as research and contain sections that include investigator contact information, the purpose of the study, a brief description of the study procedures, the alternatives, the voluntary nature, the risks, the potential benefits, a discussion of privacy and confidentiality, the costs and the payments. Each topic will also contain a reference to the page in the consent containing the full description of the topic. The form is designed to have a reading level no higher than 6th to 8th grade. Parents will also receive the full permission form, and all required signatures will still be collected on the permission form.
16159889|NCT01704534|Drug|Ustekinumab|subcutaneous injections of 45 mg or 90 mg (if the participant weighs more than 100 kg) on weeks 0 - 4 - 16 - 28
16159890|NCT01704521|Drug|PegInterferon|
16159891|NCT01704521|Drug|Ribavirin|
16159892|NCT01704521|Drug|Telaprevir|
16159893|NCT01704508|Drug|Artemether-lumefantrine|
16159894|NCT01704508|Drug|Dihydroartemisinin-piperaquine|
16159895|NCT01704495|Drug|AZD5069|AZD5069 oral capsules self-administered twice daily.
16159896|NCT01704495|Drug|Placebo|Placebo oral capsules self-administered twice daily.
16159897|NCT01704482|Drug|N-acetylcysteine|NAC bolus of 150 mg/kg in 250 mL of 5% glucose over 15 mins, followed by continuous intravenous infusion of 50 mg/kg in 250 mL of 5% glucose over 4 hrs, then 100 mg/kg in 1000 ml of 5% glucose over 20 hrs
16159898|NCT01704482|Drug|placebo|
16159899|NCT01704469|Procedure|The local anesthetic injection|
16159900|NCT01704456|Behavioral|Mindfulness-based Cognitive Therapy|The MBCT intervention will be administered in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.
16159901|NCT01704456|Behavioral|Cognitive Behavioural Therapy|The CBT intervention will be administered to women in small group format (8-9 women). Each session will be 2.25-hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.
16159902|NCT01704443|Behavioral|Group Psychoeducational Treatment|"The Group Psychoeducational Treatment consists of treatment in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be four, bi-weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.
~Participants in the Waitlist Control Condition will receive this treatment at the end of the waitlist period (approximately 8 weeks)"
16159903|NCT01704443|Other|Waitlist control|No treatment will be provided during the 8 week Waitlist control period
16159904|NCT01704430|Dietary Supplement|Glutamine|Enteric L-Glutamine
16159905|NCT01704430|Dietary Supplement|Maltodextrin|Enteric Maltodextrin
16159906|NCT01704417|Drug|insulin degludec|Subjects will be randomised to a treatment sequence consisting of two treatment periods in which the subjects will receive IDeg and IGlar, respectively. Administered subcutaneously (s.c., under the skin) once daily. Dose individually adjusted.
16159907|NCT01704417|Drug|insulin glargine|Subjects will be randomised to a treatment sequence consisting of two treatment periods in which the subjects will receive IDeg and IGlar, respectively. Administered subcutaneously (s.c., under the skin) once daily. Dose individually adjusted.
16159908|NCT01704404|Drug|TD-4208|
16159909|NCT01704404|Drug|Placebo|
16159910|NCT01704378|Drug|biphasic insulin aspart|Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily before breakfast and evening meal
16159911|NCT01704365|Biological|Low dose RSV-F Vaccine with Adjuvant|0.5mL IM Injection
16159912|NCT01704365|Biological|Low dose RSV-F Vaccine without Adjuvant|0.5ml IM Injection
16159913|NCT01704365|Biological|High dose RSV-F Vaccine with Adjuvant|0.5mL IM Injection
16159914|NCT01704365|Biological|High dose RSV-F Vaccine without Adjuvant|0.5mL IM Injection
16159915|NCT01704365|Biological|Low dose RSV-F Vaccine with Adjuvant [Bedside Mixing]|0.5mL IM Injection
16159916|NCT01704365|Biological|Placebo|0.5mL IM Injection
16159917|NCT01704352|Behavioral|Cognitive behavioral therapy for insomnia|CBT-I will be given during 3-6 sessions according to need by two therapists being either psychiatrists or psychologists with clinical experience in CBT-I.
16159918|NCT01704339|Drug|QUTENZA|Single treatment with topical capsaicin 8%
16159919|NCT01704313|Procedure|Interrupted|Interrupted suturing technique used aroudn the heel of the vascular anastomosis
16159920|NCT01704313|Procedure|Continuous|Continuous suturing technique used for the anastomosis
16159921|NCT01704287|Biological|Pembrolizumab|IV infusion
16159922|NCT01704287|Drug|Carboplatin|Carboplatin per institutional standard
16159923|NCT01704287|Drug|Paclitaxel|Paclitaxel per institutional standard
16159924|NCT01704287|Drug|Dacarbazine|Dacarbazine per institutional standard
16159925|NCT01704287|Drug|Temozolomide|Temozolomide per institutional standard
16159926|NCT01704274|Other|Low Dose GTN 0.0285 mg/hr|Low Dose GTN
16159927|NCT01704274|Other|High Dose GTN 0.057 mg/hr|High Dose GTN
16159929|NCT01704261|Drug|Omarigliptin|Omarigliptin 25 mg capsule administered orally once a week
16159930|NCT01704261|Drug|Matching placebo to Omarigliptin|Matching placebo to omarigliptin capsule administered orally once a week
16159931|NCT01704261|Drug|Glimepiride|Open-label glimepiride tablet(s) administered orally once daily for a total daily dose >=4 mg. In the event of hypoglycemia, the glimepiride dose may be down-titrated to a minimum dose of 1 mg daily.
16159932|NCT01704261|Drug|Metformin|Open-label metformin tablet(s) administered orally once or twice daily for a total daily dose >=1500 mg
16159933|NCT01704248|Device|Eye Drop Guide technique|"Wash the hands.
~Shake and then uncap the bottle.
~Hold the bottle between the thumb, index, and/or middle finger of the dominant hand.
~Use the lower lip of the cup to pull the lower lid down like what they normally do with the fingers.
~Then place the upper lip down to cover the whole orbital rim area.
~Tilt the head back if seated or standing.
~Insert the bottle in the device all the way. Hold the bottle gently.
~Look upward.
~Squeeze the bottle one drop at a time until feel one drop instilled into the eye.
~Close the eye 2-3 minutes.
~For the non-seeing eye (best-corrected visual acuity ≤ 20/400) the participants should insert the bottle in the device before cover the eye then proceed with head tilt and look upward."
16159934|NCT01704248|Behavioral|Routine self-instillation technique|"Wash the hands.
~Shake and then uncap the bottle.
~Hold the bottle between the thumb, index, and/or middle finger of the dominant hand.
~Lie down or tilt the head back if seated or standing.
~Using the other hand, pull the lower lid down.
~Hold the bottle over the eye and look up.
~Squeeze the bottle one drop at a time until feel one drop instilled into the eye.
~Close the eye 2-3 minutes.
~For the participants using more than one medication after instilling one bottle the participants should wait 3-5 minutes between administering different medications in the same eye."
16159935|NCT01704235|Other|Demographic Form and Semi-Structured Interview Guide|"The demographic form will include the following items: age, age at immigration, years lived in the United States, Vietnamese speaking ability, and marital status. In addition for participants who are primary health care providers, the following items will be included: annual income before taxes, gender, race and ethnicity, specialty area of practice, and number of years practicing as a primary health care provider, practice setting, and country received Pap test training.
~A semi-structured interview guide will also be used and will include possible probing questions. A semi-structured interview guide was developed with the research team."
16159936|NCT01704209|Drug|Fibroblast Treatment|
16159937|NCT01704209|Procedure|Vehicle|
16159938|NCT01704196|Drug|Nepicastat|120 mg of active drug and 100mg of riboflavin daily for 11 weeks or matching placebo containing 100mg of riboflavin daily for 11 weeks.
16159939|NCT01704196|Drug|Placebo|
16159940|NCT01704170|Device|Kona Externally Focused Ultrasound Therapy|
16159941|NCT01704157|Device|Cryo-Touch III|Study treatment at Day 0.
16159942|NCT01704118|Device|I-gel|Supraglottic airway device
16159943|NCT01704118|Device|ProSeal Laryngeal mask|Supraglottic airway device
16159944|NCT01704105|Behavioral|Water Quality|Hardware: Chlorine dispensers provided for free at communal water sources. Promotion: Local promoters will visit study compounds at least monthly during the first year and bi-monthly thereafter to deliver behavior change messages that focus on the treatment of drinking water for all children living in the household.
16159945|NCT01704105|Behavioral|Sanitation|"Hardware: Free child potties, sani-scoop hoes to remove feces from household environments, and new or upgraded pit latrine for each study compound. Upgrades may include structural improvements, plastic slabs, and superstructure improvements.
~Promotion: Local promoters will visit study compounds at least monthly during the first year and bi-monthly thereafter to deliver behavior change messages that focus on the use of latrines for defecation and the removal of human and animal feces from the compound."
16159946|NCT01704105|Behavioral|Handwashing|"Hardware: Handwashing dual tippy tap stations, including jugs for clean and for soapy water. Handwashing stations will be stocked with soap for the duration of the trial.
~Promotion: Local promoters will visit study compounds at least monthly during the first year and bi-monthly thereafter to deliver behavior change messages that focus on handwashing with soap at critical times around food preparation, defecation, and contact with feces."
16159947|NCT01704105|Dietary Supplement|Nutrition|"Supplement: Lipid-based Nutrient Supplement (LNS) twice daily from ages 6 to 24 months.
~Promotion: Local promoters will visit study compounds at least monthly during the first year and bi-monthly thereafter to deliver behavior change messages modeled on those recommended in the Guiding Principles for Complementary Feeding of the Breastfed Child and the recent UNICEF Program Guide for Infant and Young Child Feeding Practices. General messages will include (1) practice exclusive breastfeeding from birth to 6 months of age and introduce complementary foods at 6 months of age while continuing to breastfeed; (2) continue breast feeding as you did before receiving LNS; (3) provide your child micronutrient-rich foods such as meat, fish, eggs, and vitamin A rich fruits and vegetables; and (4) feed your child at least 2-3 times per day when 6-8 months old and 3-4 times per day when 9-24 months old."
16159948|NCT01704092|Drug|Dexmedetomidine|
16159949|NCT01704079|Drug|CTAP101 30 μg capsules|CTAP101 30 μg capsule taken daily at bedtime
16159950|NCT01704079|Other|Sugar pill to CTAP101 30 μg capsules|Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
16159951|NCT01704066|Other|Training and education|
16159952|NCT01704040|Drug|CNTO 3157 (healthy participants)|CNTO 3157 10 mg/kg, as a single intravenous infusion, on Day 1, 24 to 72 hours prior to inoculation with human rhinovirus type 16 (HRV-16).
16159953|NCT01704040|Drug|Placebo (healthy participants)|Placebo, as a single intravenous infusion, on Day 1, 24 to 72 hours prior to inoculation with HRV-16.
16159954|NCT01704040|Drug|CNTO 3157 (asthmatic patients)|CNTO 3157 10 mg/kg, as a single intravenous infusion, at Week 1 (Day 1), followed by 3 infusions of 3 mg/kg of CNTO 3157 at Week 2 (Day 8), Week 3 (Day 15), and Week 4 (Day 22). The final infusion (Week 4) will occur 24 to 72 hours prior to inoculation with HRV-16.
16159955|NCT01704040|Drug|Placebo (asthmatic patients)|Placebo, as 4 intravenous infusions, at Week 1 (Day 1), Week 2 (Day 8), Week 3 (Day 15), and Week 4 (Day 22). The final infusion (Week 4) will occur 24 to 72 hours prior to inoculation with HRV-16.
16159956|NCT01704040|Other|HRV-16|Single inoculation of HRV-16 in a total volume of approximately 1.0 mL, administered as 2 instillations per naris.
16160103|NCT01702805|Procedure|Liberal Cell Transfusion|
16160104|NCT01702805|Procedure|Restricted red cell transfusion|
16203919|NCT01363843|Procedure|Surgery|
16159957|NCT01704027|Radiation|Simultaneous integrated boost intensity-modulated arctherapy|"Three dose levels will be delivered at each fraction, 5 days a week, 30 fractions :
~Pelvis : 55,5 Gy (1,85 Gy/fr)
~Seminal vesicles : 66 Gy (2,2 Gy/fr)
~Prostate : 72 Gy (2,4 Gy/fr)"
16159958|NCT01704027|Drug|Androgen deprivation|Patients will received androgen deprivation for a maximum of three years. This treatment can start six months before radiotherapy and at least the day one of radiotherapy.
16159959|NCT01704001|Drug|ART-123|380 U/kg/day or 130 U/kg/day(Subjects with severe renal impairment) for 6 days
16159960|NCT01703988|Drug|Nusinersen|Single IT injection for each dose
16159961|NCT01703975|Other|Training in pairs (Dyad training)|
16159962|NCT01703949|Drug|Brentuximab Vedotin|Given IV
16159963|NCT01703949|Other|Laboratory Biomarker Analysis|Correlative studies
16159964|NCT01703949|Biological|Nivolumab|Given IV
16159965|NCT01703936|Other|Agricultural and life skills training program|
16159966|NCT01703923|Drug|FP01|
16159967|NCT01703923|Drug|placebo|
16159968|NCT01703910|Drug|Arm A chemotherapy|
16159969|NCT01703910|Drug|arm B chemotherapy|
16159970|NCT01703897|Device|Manometry and Impedance analysis|
16159971|NCT01703884|Drug|ASAQ|In the intervention area, obstetric, medical, drug-exposure histories will be collected at ANC visits. In addition, in the last trimester of the pregnancy (> 28 weeks of pregnancy), women will be systematically evaluated with malaria RDT for whether they have malaria parasites and treated effectively with ASAQ.
16159972|NCT01703858|Drug|BI 113608 PIB|powder for oral solution
16159973|NCT01703858|Drug|BI 113608|conventional tablet formulation
16159974|NCT01703858|Drug|BI 113608|conventional tablet formulation
16159975|NCT01703858|Drug|BI 113608|conventional tablet formulation
16159976|NCT01703858|Drug|pantoprazole 40 mg STADA|film-coated tablet
16159977|NCT01703858|Drug|BI 113608|conventional tablet formulation
16159978|NCT01703845|Drug|Tiotropium (high dose) + Olodaterol|Tiotropium + Olodaterol solution for inhalation
16159979|NCT01703845|Drug|Tiotropium (low dose) + Olodaterol|Tiotropium + Olodaterol solution for inhalation
16159980|NCT01703832|Drug|Neurexan®|0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
16159981|NCT01703819|Drug|Neurexan®|0.6 mg / tablet, 6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
16159982|NCT01703819|Other|Placebo|6 tablets, 1 tablet every 30 minutes from -180 minutes to -30 minutes
16159983|NCT01703806|Procedure|Early Surgery|MItral valve surgery
16159984|NCT01703806|Procedure|Watchful Observation|Watchful observation
16159985|NCT01703793|Drug|Test Product 49778|
16159986|NCT01703793|Drug|Test Product 10156|
16159987|NCT01703793|Drug|Vehicle (placebo)|
16159988|NCT01703767|Behavioral|Provider Education Workshop|Educational resources for physicians regarding the needs of GW1V patients.
16159989|NCT01703754|Genetic|Ad-RTS-hIL-12 and Veledimex|Oral activator ligand with adenoviral vector injection of cancer lesions
16159990|NCT01703754|Drug|Palifosfamide|Small molecule chemotherapy, IV administration
16159991|NCT01703741|Drug|Testosterone Gel (FE 999093)|
16159992|NCT01703728|Other|Highly purified menotropin (HP- hMG) treatment|No intervention: patients treated by highly purified menotropin for COS according to physicians' current practice
16159993|NCT01703715|Device|The Hydrant|"The Hydrant is a new form of drinking system that may be used to provide continuous access to hydration will be given to 20 patients. 10 of the patients will have mild cognitive impairment with Mini Mental State Examination less than 24 and 10 with normal cognitive function. Patients and staff will be interviewed to assess the feasibility of the hydrant."
16159994|NCT01703702|Drug|florbetapir (18F)|Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration
16159995|NCT01703689|Behavioral|Audit and Feedback|Descriptive statistics to each nursing home (NH) with regards to its own indicators of quality and residents' health status, and the same descriptive statistics on the sub-regional and regional levels were done to all NHs for comparative purposes.
16159996|NCT01703689|Behavioral|Cooperative Work|Nursing homes (NH)in the strong intervention group had two half-day meetings of cooperative work with a hospital geriatrician to identify NHs' weaknesses regarding quality of care and to establish strategies for overcoming these weaknesses.
16159997|NCT01703663|Device|EPAP|
16159998|NCT01703650|Drug|iopromide|"iopromide (370mgI/mL) enhanced perfusion CT will be performed within 14 days of operation.
~In patients who are planned to receive chemotherapy, iopromide enhanced perfusion CT was performed twice; within 14 days before starting 1st cycle and within 14 days after finishing 2nd cycle.
~iopromide (370mgI/mL) will be administered intravenously with an amount of 30mL (body weight[BW] <50kg) or 35 mL (50kg ≤BW <70kg) or 40 mL (70 kg≤BW <90kg) or 50 mL (90≤BW), followed by saline infusion (30mL).
~Injection rate is as follows; 6.0mL/sec if BW is <50kg, 7.0 mL/sec if BW is 50kg≤and <70kg, 8.0 mL/sec if BW is 70≤and<90kg and 9.0mL/sec if BW is 90kg≤."
16159999|NCT01703650|Procedure|CT|"Perfusion CT will be performed by using a 320 channel MDCT
~Patients are requested for fasting for at least 8 hours before CT scan.
~Patients are requested for doing shallow breathing as slow as possible and wide strap is applied during CT scan.
~Scan range is limited to the whole pancreas and it focuses to the pancreas tumor lesion.
~During perfusion CT, 19 phases (ten phases with two seconds interval and six phases with three seconds interval and three phases with five seconds interval) are obtained in fifty three seconds.
~ADIR 3D and SURE EXPOSURE 3D are applied during perfusion CT to minimize radiation dose."
16160000|NCT01703637|Drug|Sitagliptin|"before breakfast：a tablet of sitagliptin; a tablet of vildagliptin's dummy; a tablet of saxagliptin's dummy
~before dinner：a tablet of sitagliptin's dummy; a tablet of vildagliptin's dummy; a tablet of saxagliptin's dummy"
16160001|NCT01703637|Drug|Vildagliptin|"before breakfast：a tablet of vildagliptin; a tablet of sitagliptin's dummy; a tablet of saxagliptin's dummy
~before dinner：a tablet of vildagliptin; a tablet of sitagliptin's dummy; a tablet of saxagliptin's dummy"
16160002|NCT01703637|Drug|Saxagliptin|"before breakfast：a tablet of saxagliptin; a tablet of vildagliptin's dummy; a tablet of sitagliptin's dummy
~before dinner：a tablet of saxagliptin's dummy; a tablet of vildagliptin's dummy; a tablet of sitagliptin's dummy"
16160003|NCT01703624|Drug|glycopyrronium bromide|glycopyrronium bromide suspension in HFA
16223501|NCT01211951|Drug|KCT-0809|
16160004|NCT01703611|Other|MNT according to AND EBNPG for Type 2 DM|Six or more Medical Nutrition Therapy visits(education and counseling on diet, self management, and lifestyle changes) provided over a 12 month period according to Academy of Nutrition and Dietetic Evidence Based Nutrition Practice Guidelines (EBNPG)(www.guidelines.gov)
16160005|NCT01703611|Other|Usual Nutrition Care|Usual nutrition care in India
16160006|NCT01703598|Device|Deep Brain Stimulation|Placement of Deep Brain Stimulation electrodes
16160007|NCT01703598|Procedure|DBS surgery|Placement of DBS electrodes
16160008|NCT01703572|Drug|OMP-52M51|
16160009|NCT01703559|Drug|Phentolamine Mesylate Ophthalmic Solution 1.0%|Phentolamine mesylate (Nyxol) ophthalmic solution 1.0% is a non-selective alpha-1 and alpha-2 adrenergic antagonist
16160010|NCT01703559|Drug|Phentolamine Mesylate Ophthalmic Solution 0.5%|Phentolamine mesylate (Nyxol) ophthalmic solution 0.5% is a non-selective alpha-1 and alpha-2 adrenergic antagonist
16160011|NCT01703559|Other|Phentolamine Mesylate Ophthalmic Solution Vehicle (Placebo)|Placebo (vehicle) is a sterile, isotonic, buffered aqueous solution containing mannitol and sodium acetate
16160012|NCT01703546|Procedure|LAGB & LGCP|All study patients will have the following surgical procedures: Laparoscopic Adjustable Gastric Band & Laparoscopic Gastric Plication. % Excess Body Weight Loss will be monitored at each post op visit.
16160013|NCT01703533|Drug|NNZ-2566|Glycyl-L-2-Methylpropyl-L-Glutamic Acid (NNZ-2566) supplied as a lyophilized powder (2g in 50mL vials) for reconstitution with strawberry flavored solution 0.5% v/v in Water for Injection.
16160014|NCT01703533|Drug|Placebo|Strawberry flavored solution and Water for Injection
16160015|NCT01703507|Drug|Ipilimumab|Given IV
16160016|NCT01703507|Radiation|Whole-Brain Radiation Therapy (WBRT)|Undergo WBRT
16160017|NCT01703507|Radiation|Stereotactic Radiosurgery (SRS)|Undergo SRS
16160018|NCT01703494|Biological|Fecal Microbiota Transplantation|Fecal microbiota transplantation (FMT) involves administering fecal material from a healthy individual (donor) to a sick patient (with relapsing C. difficile infection) to restore missing components of normal intestinal flora. After completing at least a 10 day course of vancomycin for treatment of the most recent acute C. difficile infection, subjects will receive fecal microbiota transplantation (FMT) with a 300 mL donor fecal suspension delivered via colonoscopy.
16160019|NCT01703494|Biological|Sham Fecal Microbiota Transplantation|After completing at least a 10 day course of vancomycin for treatment of the most recent acute C. difficile infection, subjects will receive a sham fecal microbiota transplantation (FMT) with a 300 mL sham fecal suspension delivered via colonoscopy. This sham solution will be a reinfusion of the subject's own stool.
16160020|NCT01703481|Drug|JNJ-42756493: Part 1|Participants will receive 0.5 mg (starting dose) capsule of JNJ-42756493 orally (by mouth) once daily on Day 1 of Cycle 1. Dose of the study medication will be escalated sequentially till the dose limiting toxicity is achieved to determine the recommended part 2 doses (RP2D).
16160021|NCT01703481|Drug|JNJ-42756493: Part 2|Participants will receive JNJ-42756493 at the RP2D or below RP2D (maximum tolerated dose from Part 1) orally once daily on a 21 days cycle to confirm RP2D (in Part 2).
16160022|NCT01703481|Drug|JNJ-42756493: Part 3|Participants will receive JNJ-42756493 at first RP2D of 9 mg daily in Part 3 orally once daily on a 21 days cycle.
16160023|NCT01703481|Drug|JNJ-42756493: Part 4|Participants will receive JNJ-42756493 second RP2D of 10 mg intermittent dosing in Part 4 (with option to increase to 12 mg intermittent dosing based on phosphate level), orally on an intermittent schedule of daily for 7 days followed by 7 days off with a 28-day cycle.
16160024|NCT01703468|Drug|Oxcarbazepine|
16160025|NCT01703455|Drug|Sorafenib|400 mg twice daily, on a continuous basis (each morning and evening), in 4 week cycles
16160026|NCT01703390|Drug|FOLFIRI + Cetuximab|
16160027|NCT01703390|Drug|modifiedFOLFOX6 + Cetuximab|
16160028|NCT01703364|Drug|Lenalidomide|"Lenalidomide: day 8-21 of cycle 1 and day 1-21 of cycles 2-6; Starting Dose: 5 mg (first 5 patients) and 10 mg (further 5 patients) increase Lenalidomide dose via dose levels (10)/15/20/25 mg/d every 28 days if no limiting toxicity occurs
~Fludarabine: 25 mg/m2 iv d1-3 or 40 mg/m2 po d1-3; repeat every 28 days
~Rituximab: 375 mg/m2 iv day 4 on cycle 1 and 500 mg/m2 iv day 1 on cycles 2-6; repeat every 28 days"
16160029|NCT01703351|Drug|0.5% ropivacaine|(n=48); continuous paravertebral infusion of local anesthetics (0.5% ropivacaine, 5cc/hr for 60 hours after operation) thorough catheter below the parietal pleura using On-Q® system(I-flow corp, Lake Forest, CA, USA)
16160030|NCT01703351|Drug|Fentanyl 500mcg + acupan 160mg + nasea 0.6mg|(n=48); IV PCA (Fentanyl 500mcg + acupan 160mg + nasea 0.6mg, 5cc/hr for 60 hours after operation, 0.5cc bolus if patients feel breakthrough pain)
16160031|NCT01703325|Drug|0.1% triamcinolone , 0.05% clobetasol propionate ointment|"Three finger nails are chosen from the equally average NAPSI scores which are evaluated by two independent dermatologists. Block randomization are performed to arrange such fingers into group A, B or C
~Group A: Triamcinolone injection (10 mg/ml) on 4 sites for the pathology from both nail matrix (B) and nail bed (A) or 2 sites for the pathology from either nail matrix(B) or nail bed (A) as shown in picture, the EMLA was applied before injection
~Group B: Apply Topical 0.05% clobetasol propionate ointment (Dermovate®) on the nail fold twice daily for 6 months
~Group C: Controlled group"
16160032|NCT01703312|Drug|QGE031|Drug administered by subcutaneous injection
16160033|NCT01703312|Drug|omalizumab|Drug administered by subcutaneous injection
16160034|NCT01703312|Drug|placebo|Drug administered by subcutaneous injection
16160035|NCT01703286|Drug|Placebo|Placebo matching Glimepiride
16160036|NCT01703286|Drug|Linagliptin|given once daily for 28 days
16160037|NCT01703286|Drug|Placebo|Placebo matching Linagliptin
16160038|NCT01703286|Drug|Placebo|Placebo matching Linagliptin
16160039|NCT01703286|Drug|Placebo|Placebo matching Glimepiride
16160040|NCT01703286|Drug|Glimepiride|1 mg for 7 days followed by uptitration to 2 mg (given for following 21 days)
16160041|NCT01703273|Behavioral|manual based low key group intervention (innovation)|6 sessions offered over the course of 3-6 months focus on improvement of quality of life and psychosocial functioning . Topics covered are: 1) social competencies, 2) body image, 3) coping with mobbing and anger, 4) coping with stress, 5) life satisfaction, and 6) psychological well being. The planned intervention does not primarily focus on weight loss.
16160159|NCT01702506|Drug|dacomitinib+antacid|Subjects will receive a single 45 mg dose of dacomitinib when there are treated with rabeprazole
16160042|NCT01703273|Behavioral|standardized, manual based routine care|6 sessions offered over the course of 3-6 months with a focus on weight loss. The topics 1) causes, consequences and treatment options of obesity, 2) nutrition, 3) eating behaviors and problem solving strategies, 4) self esteem and emotional eating, 5) exercise, and 6) use of media, will be covered.
16160043|NCT01703260|Drug|Roflumilast|Roflumilast dose
16160044|NCT01703260|Drug|Pioglitazone|Pioglitazone dose
16160045|NCT01703260|Drug|Placebo|Pioglitazone placebo-matching dose
16160046|NCT01703260|Drug|Placebo|Roflumilast placebo-matching dose
16160047|NCT01703247|Procedure|Pulmonary vein isolation|
16160048|NCT01703247|Procedure|Ganglionated plexi ablation|
16160049|NCT01703247|Procedure|Linear Lesion Ablation|
16160050|NCT01703234|Drug|Ramipril|ramipril 10 mg/day during 3 months
16160051|NCT01703221|Drug|Omarigliptin|Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly
16160052|NCT01703221|Drug|Sitagliptin|Sitagliptin 50 mg tablet administered orally once daily
16160053|NCT01703221|Drug|Placebo to omarigliptin|Placebo to omarigliptin 25 mg capsule administered orally once weekly
16160054|NCT01703221|Drug|Placebo to sitagliptin|Placebo to sitagliptin 50 mg tablet administered orally once daily
16160055|NCT01703208|Drug|Omarigliptin|Omarigliptin (MK-3102) 25 mg capsule or tablet administered orally once weekly
16160056|NCT01703208|Drug|Placebo|Matching placebo to omarigliptin capsule or tablet administered orally once weekly
16160057|NCT01703195|Procedure|Magnetic Resonance Imaging (MRI)|Magnetic Resonance Imaging (MRI) obtained pre-treatment and 4-6 weeks post-treatment.
16160058|NCT01703195|Procedure|Diffusion Weighted Magnetic Resonance Imaging (DWMR)|Diffusion Weighted Magnetic Resonance Imaging (DWMR) obtained pre-treatment and 4-6 weeks post-treatment.
16160059|NCT01703169|Drug|Eltrombopag|Oral eltrombopag 150mg/day by mouth starting on Day 1 with dose modification over 12 weeks to a maximum of 300mg/day determined by platelet count
16160060|NCT01703156|Procedure|Stress Test|
16160061|NCT01703156|Procedure|No Stress Test|
16160062|NCT01703143|Procedure|Laser ablation|Laser ablation of focal lesions in patients with medically refractory partial epilepsy.
16160063|NCT01703130|Procedure|Dose of of ropivacaine 0.75% used in block procedure|
16160064|NCT01703117|Drug|Riluzole|20-22 subjects between the ages of 60-85 will receive study drug.
16160065|NCT01703117|Drug|Placebo|20-22 subjects between the ages of 60-85 will receive placebo
16160066|NCT01703104|Drug|Paludrine + Folic Acid|This is the combination of routine drugs for treating sickle cell disease
16160067|NCT01703104|Dietary Supplement|Paludrine + Folic Acid + Jobelyn|Combination of routine drugs + Jobelyn
16160068|NCT01703091|Drug|Ramucirumab|Administered IV
16160069|NCT01703091|Drug|Placebo|Administered IV
16160070|NCT01703091|Drug|Docetaxel|Administered IV
16160071|NCT01703078|Drug|Ingenol once daily for two consecutive days|
16160072|NCT01703065|Drug|Cabozantinib|Given orally once a day
16160073|NCT01703052|Drug|CHF 6001 SD or placebo|Dry Powder Inhaler
16160074|NCT01703052|Drug|CHF 6001 MD or placebo|Dry Powder Inhaler
16160075|NCT01703039|Drug|Riluzole|
16160076|NCT01703039|Drug|Sertraline|
16160077|NCT01703039|Other|placebo|
16160078|NCT01703000|Device|Percutaneous coronary intervention (NG PROMUS)|Interventional coronary artery stenting with NG PROMUS study stent.
16160079|NCT01702987|Dietary Supplement|ubiquinol|ubiquinol supplementation was given for 1 month to 12 patients
16160080|NCT01702987|Dietary Supplement|placebo|placebo (identical in appearance to ubiquinol) was given for 1 month to 9 patients
16160081|NCT01702987|Drug|statin|statin was given for 1 month to 21 patients
16160082|NCT01702974|Drug|vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)|Dose of interventions: 5,000 IU of vitamin D (cholecalciferol tablets) once daily and 500 mg PBA (sodium phenylbutyrate tablets) twice daily for 16 weeks.
16160083|NCT01702974|Drug|Placebo tablets|Placebo tablets for vitamin D once daily and placebo tablets for PBA (phenylbutyrate) twice daily for 16 weeks.
16160084|NCT01702961|Drug|Melphalan|"Given on Day -1
~Melphalan is administered according to the current SOP."
16160085|NCT01702961|Drug|Ara-C|200 mg/m2 IB BID given on Days -5, -4, -3, -2
16160086|NCT01702961|Drug|VP-16|200 mg/m2 IV BID given on Days -5, -4, -3, -2
16160087|NCT01702961|Drug|BCNU|BCNU 300 mg/m2 IV given on Day -6
16160088|NCT01702961|Drug|Rituxan|375 mg/m2 IB given on Days -6, +14, +21, +28
16160089|NCT01702961|Drug|Stem Cells|Stem cells given on Day 0
16160090|NCT01702909|Drug|Interleukin-2|Interleukin-2
16160091|NCT01702896|Drug|Interleukin-2|Interleukin-2
16160092|NCT01702883|Other|Internet Survey|prompt to complete internet survey
16160093|NCT01702870|Procedure|Magnetic Resonance Imaging|
16160094|NCT01702857|Biological|Biological/Vaccine: 4 µg TDENV-PIV with Alum adjuvant|
16160095|NCT01702857|Biological|Biological/Vaccine: 1 µg TDENV-PIV with AS03B adjuvant|
16160096|NCT01702857|Other|Phosphate buffered saline|
16160097|NCT01702857|Biological|1 µg TDENV-PIV with Alum adjuvant|
16160098|NCT01702857|Biological|1 µg TDENV-PIV with AS01E adjuvant|
16160099|NCT01702844|Drug|Nab-Paclitaxel|Administer 2 cycles of Nab-Paclitaxel 100 mg/m2 IV on days 1 8 and 15
16160100|NCT01702831|Drug|Busulfan|Once daily intravenous (IV) busulfan at a dose of 3.2 mg/kg or equivalent pharmacokinetics directed dose for three consecutive days (days -5 to -3), option 1 OR Once daily intravenous (IV) busulfan at a dose of 3.2mg/kg or equivalent pharmacokinetics directed dose for three consecutive days (days -6 to -4), option 2.
16160101|NCT01702831|Drug|Melphalan|"I.V. reduced dose of melphalan (140mg/m2) on day -2, followed by an autologous stem cell transplant on day 0 (day -1 will be a rest day) - this is referred to as Option 1 dosing schema OR I.V. reduced dose of melphalan (140mg/m2) on day -3 followed by autologous stem cell transplant on day 0 (days -2 and -1 will be rest days). This is referred to as Option 2"
16160102|NCT01702831|Drug|Lenalidomide|Oral lenalidomide 10mg per day (on all 28 days of a 28 day cycle) for the first three cycles and then escalated to 15 mg daily if clinically appropriate to do so. The lenalidomide maintenance will start on day 100 post ASCT and continue till disease progression.
16160105|NCT01702792|Biological|Tumor Vaccine|Tumor cells obtained at the time of surgery are irradiated with 10,000 Gy and freeze fractured. Lysate at 1x107 tumor cell equivalent (TCE) will be used for vaccination with adjuvant, Montanide ISA 51 VG.
16160106|NCT01702779|Other|mechanical ventilation|Prospective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation.
16160107|NCT01702779|Other|mechanical ventilation|Prospective, randomized clinical multicentric study in ICU (Intensive Care University)during weaning from mechanical ventilation.
16160108|NCT01702766|Dietary Supplement|Bifidobacterium animalis subsp. lactis|
16160109|NCT01702753|Dietary Supplement|Bifidobacterium animalis subsp. lactis|
16160110|NCT01702740|Drug|1 mg/kg CNTO 136|Type=exact number, unit=mg, number=1, form=powder for solution for infusion, route=intravenous use, every 2 weeks for 6 weeks.
16160111|NCT01702740|Drug|4 mg/kg CNTO 136|Type=exact number, unit=mg, number=4, form=powder for solution for infusion, route=intravenous use, every 2 weeks for 6 weeks.
16160112|NCT01702740|Drug|10 mg/kg CNTO 136|Type=exact number, unit=mg, number=10, form=powder for solution for infusion, route=intravenous use, every 2 weeks for 6 weeks.
16160113|NCT01702740|Drug|Placebo|Form=liquid for infusion, route=intravenous use, every 2 weeks for 6 weeks.
16160114|NCT01702727|Device|I-BiTTM game|30 minutes intervention weekly for 6 weeks.
16160115|NCT01702727|Device|Non-I-BiTTM game|30 minutes intervention weekly for 6 weeks.
16160116|NCT01702727|Device|I-BiTTM DVD|30 minutes intervention weekly for 6 weeks.
16160117|NCT01702714|Drug|RO5083945|multiple ascending doses
16160118|NCT01702714|Drug|carboplatin|up to 6 cycles
16160119|NCT01702714|Drug|cisplatin|up to 6 cycles
16160120|NCT01702714|Drug|gemcitabine|up to 6 cycles
16160121|NCT01702714|Drug|paclitaxel|up to 6 cycles
16160122|NCT01702701|Drug|Montelukast|montelukast 10mg po pill q day for 12 weeks
16160123|NCT01702701|Drug|Fluticasone|fluticasone 440mcg po q bid x 12 weeks
16160124|NCT01702688|Drug|Para-aminohippuric Acid|"Aminohippurate sodium is an agent to measure effective renal plasma flow (ERPF). It is the sodium salt of para-aminohippuric acid, commonly abbreviated PAH."
16160125|NCT01702688|Drug|Angiotensin II|Angiotensin II (Ang II) is a naturally occurring hormone whose primary purpose is to regulate the body's internal volume. It accomplishes this task by influencing the function of a variety of organs and tissues. It increases aldosterone secretion from the adrenal gland. It causes blood vessels to contract, particularly renal blood vessels, and it modifies the way the heart works.
16160126|NCT01702675|Drug|ACH15 50 mg|ACH15 50mg capsule
16160127|NCT01702675|Drug|ACH15 250 mg|ACH15 250mg capsule
16160128|NCT01702675|Drug|ACH15 500mg|ACH15 500 mg capsule
16160129|NCT01702675|Drug|ACH15 - 1000mg|ACH15 500mg capsule - two 500mg capsules in single dose
16160130|NCT01702675|Drug|ACH15 - 2000mg|ACH15 500mg capsule (four 500mg capsules in one dose)
16160131|NCT01702675|Drug|ACH15 - 500mg|ACH15 - 500mg twice a day for 7 days
16160132|NCT01702675|Drug|Placebo 250 mg|Capsule manufactured to mimic ACH15 250 mg capsule
16160133|NCT01702675|Drug|Placebo 500mg|Capsule manufactured to mimic ACH15 500 mg capsule
16160134|NCT01702675|Drug|Placebo 1000mg|Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (two 500 mg capsules in one dose)
16160135|NCT01702675|Drug|Placebo 2000mg|Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (four 500 mg capsules in one dose)
16160136|NCT01702675|Drug|Placebo 500mg|Capsule manufactured to mimic ACH15 500 mg capsule Placebo 500mg (500 mg capsules twice a day for 7 days)
16160137|NCT01702662|Device|Photopill treatment|2 courses of 5 Photopill treatments within 14 days. In each treatment, 3cm of rectal tissue will be exposed, 2 minutes per cm, to low level light therapy.
16160138|NCT01702649|Drug|RPX2003 (Biapenem)|"Six (6) cohorts of 3 active or 8 subjects of 6 active are planned for evaluation.
~Single dose followed by multiple dose, three times a day."
16160139|NCT01702649|Drug|Placebo|"Six (6) cohorts of 1 placebo or 8 subjects of 2 placebo are planned for evaluation.
~Single dose followed by multiple dose, three times a day."
16160140|NCT01702636|Drug|Tranexamic Acid|
16160141|NCT01702636|Drug|Placebo|
16160142|NCT01702623|Drug|Oxcarbazepine|
16160143|NCT01702610|Radiation|IMRT Technique|
16160144|NCT01702610|Radiation|IMRT and accelerated hypofractionation technique|Intervention is the technique and accelerated fractionation used to treat GBM
16160145|NCT01702610|Radiation|neo-adjuvant TMZ followed by accelerated hypofractionated EBRT|Two weeks of neo-adjuvant TMZ followed by XRT+TMX followed by TMZ as adjuvant component
16160146|NCT01702610|Drug|Temozolomide and Accelerated Hypofractionation RT|
16160147|NCT01702597|Device|Whole body vibration (Galileo® Med M Plus, Novotec, Pforzheim, Germany)|Patients will train on a WBV platform, following a standardized protocol, aiming at improving strength, endurance and proprioception of both legs.
16160148|NCT01702597|Other|Physiotherapy|Patients will receive a standardized physical therapy.
16160149|NCT01702584|Procedure|stent assisted embolization|stent assisted embolization and anti-thrombotic management
16160150|NCT01702571|Drug|Trastuzumab Emtansine|Participants will receive trastuzumab emtansine 3.6 milligrams per kilogram (mg/kg) intravenously on Day 1 of a 3-week cycle every 3 weeks until unacceptable toxicity, withdrawal of consent, or disease progression.
16160151|NCT01702558|Drug|Capecitabine|Capecitabine will be administered at de-escalating doses (starting from 750 mg/m^2) to determine the MTD.
16160152|NCT01702558|Drug|Trastuzumab emtansine (T-DM1)|Trastuzumab emtansine will be administered at a dose of 3.6 mg/kg via IV infusion every 3 weeks.
16160153|NCT01702558|Drug|Trastuzumab emtansine (T-DM1)|Trastuzumab emtansine will be administered at a dose of 2.4 mg/kg via IV infusion every week.
16160154|NCT01702558|Drug|Capecitabine|Capecitabine will be administered at the MTD determined in Cohort 1.
16160155|NCT01702532|Drug|Nicotine|Comparison of different dosage forms of nicotine
16160156|NCT01702519|Drug|nicotine|nicotine transdermal patch
16160157|NCT01702506|Drug|dacomitinib fasted|Overnight fasted subjects will receive a single 45 mg dose of dacomitinib
16160158|NCT01702506|Drug|dacomitinib fed|Subjects will receive a single 45 mg dose of dacomitinib with a high calorie high fat meal
16160209|NCT01702181|Drug|Placebo|
16160160|NCT01702493|Drug|Cap SRT2104|Micronized free base in a 250 mg SRT2104 (active equivalents) capsule
16160161|NCT01702493|Drug|Tab SRT2104 slow release|New 250 mg SRT2104 mesylate salt slow release tablet
16160162|NCT01702493|Drug|Tab SRT2104 intermediate release|New 250 mg SRT2104 mesylate salt intermediate release tablet
16160163|NCT01702493|Drug|Tab SRT2104 fast release|New 250 mg SRT2104 mesylate salt fast release tablet
16160164|NCT01702493|Drug|Selected formulations of SRT2104 from Part 1|SRT2104 500 mg of selected formulation(s) from Part 1 in single-dose or daily for 7 days
16160165|NCT01702493|Drug|Selected formulations of SRT2104 from Part 1 single alternative dose|SRT2104 single alternative dose (other than 500 mg, but not to exceed 2000 mg) of selected formulation(s) from Part 1
16160166|NCT01702480|Drug|GSK2981710|Will be available as 10 g medium-chain triglycerides (MCT) powder sachet that will be mixed with 125 - 250 milliliters (ml) water in a shaker and taken within 15 minutes of completion of breakfast
16160167|NCT01702480|Drug|Placebo|Will be available as matching powder that will be mixed with 125 - 250 milliliters (ml) water in a shaker and taken within 15 minutes of completion of breakfast
16160168|NCT01702467|Drug|GSK2647544|Capsules containing 0.5mg to 50mg of GSK2647544.
16160169|NCT01702467|Drug|Placebo|Matching placebo capsules.
16160170|NCT01702454|Biological|Fluarix Quadrivalent|1 or 2 doses administered intramuscularly (IM) in deltoid region depending on the priming status
16160171|NCT01702441|Drug|Subcutaneous AKB-9778|
16160172|NCT01702428|Biological|Priorix|Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.
16160173|NCT01702428|Biological|M-M-R II|Subjects receive 1 dose of MMR vaccine which is administered subcutaneously in the triceps region of the left arm.
16160174|NCT01702428|Biological|Varivax|Subjects receive 1 dose of VV vaccine which is administered subcutaneously in the triceps region of the right arm.
16160175|NCT01702428|Biological|Havrix|Subjects receive 1 dose of HAV vaccine which is administered intramuscularly in the anterolateral region of the right thigh.
16160176|NCT01702428|Biological|Prevnar 13|US subjects receive 1 dose of PCV-13 vaccine which is administered intramuscularly in the anterolateral region of the left thigh.
16160177|NCT01702415|Drug|Zoledronic acid|Single dose, intravenous solution 5mg
16160178|NCT01702415|Drug|Placebo|
16160179|NCT01702402|Behavioral|Educational and Behavior Change intervention|"Integrate post-partum family planning education and counselling into 2nd Antenatal Home visit by CHW (at approximately 32 weeks of pregnancy) Integrate post-partum family planning education and counselling into post-partum visits by CHWs during first month Continue providing family planning education and counselling to women through CHW home visits after first month.
~Promote discussion and acceptance of post-partum family planning methods among key household members.
~Facility level Ensure availability of postpartum contraceptive methods such as progestin-only pill.
~Ensure availability of post-partum family planning and post-natal services. Community level Increase community awareness of the importance of birth spacing and benefits of LAM Educate influential community members on the importance of birth spacing and benefits of LAM."
16160180|NCT01702402|Other|Comparison Group|A comparison area received standard government health services.
16160181|NCT01702389|Drug|Remifentanil|
16160182|NCT01702376|Drug|Retosiban 100 mg|Subjects will be administered with single dose of one moxifloxacin placebo tablet, one 100 mg tablet of retosiban and 7 retosiban matched placebo tablets
16160183|NCT01702376|Drug|Retosiban 800 mg|Subjects will be administered with single dose of one moxifloxacin placebo tablet and eight 100 mg tablets of retosiban
16160184|NCT01702376|Drug|Placebo|Subjects will be administered with one moxifloxacin placebo tablet and eight retosiban matched placebo tablets
16160185|NCT01702376|Drug|Moxifloxacin 400 mg|Subjects will be administered with one 400 mg moxifloxacin tablet and eight retosiban matched placebo tablets
16160186|NCT01702363|Drug|GSK573719|GSK573719 inhalation powder inhaled orally once daily for 52 weeks.
16160187|NCT01702350|Drug|GSK2251052|Oral formulation of an an antibacterial
16160188|NCT01702337|Other|Prevalence-based model|Static prevalence-based model to estimate vaccine effect over a one-year period at a steady state (when all women are fully vaccinated).
16160189|NCT01702324|Drug|DD-25|A topical DD-25 cream at 0.025% concentration.
16160190|NCT01702311|Drug|Bedtime insulin Aspart (Novolog)|Bedtime insulin aspart supplementation based on blood glucose value in the bedtime supplementation arm.
16160191|NCT01702298|Drug|Sitagliptin 100 mg/simvastatin 40 mg FDC|Sitagliptin 100 mg/simvastatin 40 mg FDC tablet administered once daily in the evening for 6 weeks
16160192|NCT01702298|Drug|Metformin|Participants will continue pre-study dose of metformin tablet(s) >=1000 per day
16160193|NCT01702285|Drug|CUDC-101|200-500 mg CUDC-101, orally administered, twice daily, in continuous 21 day cycles until disease progression or other discontinuation criteria are met.
16160194|NCT01702272|Device|Procleix Dengue Virus Assay|in vitro diagnostic assay
16160195|NCT01702259|Device|Erchonia Scanner device (GLS)|The Erchonia® GLS device is made up of six independent diodes, each emitting 17 milliwatts (mW), 532 nanometer (nm) of green laser light.
16160196|NCT01702259|Device|Placebo device|Inactive Erchonia GLS.
16160197|NCT01702246|Drug|Simvastatin|40 mg, orally, once daily for 3 months
16160198|NCT01702233|Drug|Traumeel S inj|Traumeel S inj. 2 ml. subacromial 3 times at days 1, 8 and 15
16160199|NCT01702233|Drug|Fortecortin/Dexamethasone 8 mg/2 ml inj|Fortecortin/Dexamethasone 8 mg/2 ml inj. subacromial 3 times at days 1, 8 and 15
16160200|NCT01702233|Drug|Saline inj|Saline inj. 2 ml. subacromial 3 times at days 1, 8 and 15
16160201|NCT01702220|Behavioral|CBT|6-12 sessions of CBT in person or over the phone
16160202|NCT01702220|Other|ECC|6 biweekly sessions of ECC over the telephone
16160203|NCT01702207|Drug|Once Daily Tacrolimus|Subjects switched from the tacrolimus twice daily (Prograf®) to the once daily formulation (Advagraf®) to maintain a trough tacrolimus level of 5-8.
16160204|NCT01702207|Drug|Twice Daily Tacrolimus|Subjects are kept on Prograf® which is the Twice Daily Tacrolimus
16160205|NCT01702194|Drug|TD-1211 IV [C14]|
16160206|NCT01702194|Drug|TD-1211 PO [C14]|
16160207|NCT01702181|Drug|OPA-15406|0.3%, 1%, or 3% OPA-15406 topical ointment, applied twice daily for 28 days
16160208|NCT01702181|Drug|Tacrolimus|0.1% concentration of tacrolimus.
16160210|NCT01702168|Other|Provider training: Cognitive Processing Therapy (CPT)|
16160211|NCT01702155|Drug|DFP-10917|
16160212|NCT01702129|Drug|anti-EGFR immunoliposomes loaded with doxorubicin|All patients were treated with anti-EGFR immunoliposomes Different dose levels (5, 10, 20, 30, 40, 50 and 60 mg doxorubicin/m2), at least 3 patients per dose level, treatment was given every 4 weeks
16160213|NCT01702116|Procedure|extralevator APR|"Extralevator Abdominoperineal Resection For Rectal Adenocarcinoma. The aim of this modified and more extensive procedure is to remove the levator muscle en bloc with the anal canal and the mesorectum, creating a more cylindrical specimen, so that the amount of tissue removed around the tumor will be larger, thereby reducing the probability that the CRM will be positive."
16160214|NCT01702116|Procedure|APR|standard Abdominoperineal Resection For Rectal Adenocarcinoma
16160215|NCT01702103|Drug|Mometasone furoate|
16160216|NCT01702090|Drug|TMC114/ritonavir|TMC114 800 mg (two tablets) once daily coadministered with ritonavir 100 mg (one capsule) once daily within 30 minutes after completion of a meal, and in combination with other ARVs.
16160217|NCT01702077|Procedure|Neurofeedback|
16160218|NCT01702077|Procedure|Sham feedback|
16160219|NCT01702064|Drug|Nilotinib|"Participants will remain on the same dose of nilotinib they have been receiving prior to enrollment on the trial. This will range from 300 mg PO BID to 400 mg PO BID.
~Dose modifications will not occur, as the purpose of this study is to determine the maximum tolerated dose of ruxolitinib, based on the number of dose."
16160220|NCT01702064|Drug|Ruxolitinib|Dose escalation will follow a 3+3 study design. Dose modifications will not occur, as the purpose of this study is to determine the maximum tolerated dose, based on the number of dose limiting toxicities seen at a specific dose.
16160221|NCT01702038|Drug|Rituximab|1000 mg administered intravenously
16160222|NCT01702025|Drug|Placebo|Yellow corn meal in gel capsules
16160223|NCT01702025|Drug|Aminophylline|National Drug Code (NDC) 0143-1020-01
16160224|NCT01702025|Drug|Methazolamide|NDC 0781-1072-01
16160225|NCT01702025|Drug|Aminophylline+Methazolamide|NDC 0143-1020-01 and NDC 0781-1072-01
16160226|NCT01702012|Dietary Supplement|Almased Meal Replacement Powder|Commercially available meal replacement product that contains soy protein, honey, yogurt, and amino acids. Participants assigned to this arm will receive the Almased meal replacement product and will be asked to replace one meal per day during the first 6 month. During the second 6 months, they will be allowed to choose to continue using the Almased as a meal replacement or to use it as a supplement prior to meals.
16160227|NCT01702012|Behavioral|Group-Based Lifestyle Intervention|
16160228|NCT01701999|Biological|rBV A/B|rBV A/B injections will consist of a single 40 µg injection of total antigen (20 µg of Antigen A and 20 µg of Antigen B) adsorbed to 0.2% (wt/vol) Alhydrogel™, in a total dose volume of 0.5 mL. The vaccine will be administered by intramuscular injection in the deltoid muscle, preferably in the nondominant arm.
16160229|NCT01701986|Procedure|Allogeneic Bone Marrow Transplantation|Undergo allogeneic BMT
16160230|NCT01701986|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic BMT or PBSCT
16160231|NCT01701986|Biological|Anti-Thymocyte Globulin|Given IV
16160232|NCT01701986|Drug|Busulfan|Given IV
16160233|NCT01701986|Drug|Clofarabine|Given IV
16160234|NCT01701986|Drug|Gemcitabine Hydrochloride|Given IV
16160235|NCT01701986|Drug|Mycophenolate Mofetil|Given IV then PO
16160236|NCT01701986|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo allogeneic PBSCT
16160237|NCT01701986|Other|Pharmacological Study|Correlative studies
16160238|NCT01701986|Biological|Rituximab|Given IV
16160239|NCT01701986|Drug|Tacrolimus|Given IV then PO
16160240|NCT01701973|Drug|Sitagliptin|During Aim 1, given on one of two study days (other study day subjects receive placebo.) During Aim 2, given during both of two study days.
16160241|NCT01701973|Drug|Pegvisomant|During Aim 2, given 72 hours prior to one of two study days (Group B subjects only)
16160242|NCT01701973|Drug|Placebo|During Aim 1, given on one of two study days (other study day subjects receive sitagliptin.) During Aim 2, given on one of two study days (other study day subjects receive either L-NMMA, pegvisomant, or Exendin 9-39 pending their group assignment)
16160243|NCT01701973|Drug|L-NMMA|During Aim 2, given during one of two study days (Group A subjects only)
16160244|NCT01701973|Drug|Exendin 9-39|During Aim 2, given during one of two study days (Group C subjects only)
16160245|NCT01701947|Biological|Hemoleven|Replacement therapy
16160246|NCT01701934|Drug|Roflumilast|500 mcg, oral, once daily for 6 months
16160247|NCT01701934|Drug|Placebo|One placebo pill daily, for 6 months
16160248|NCT01701921|Drug|Pregabalin 75mg|Pregabalin 75mg by mouth one hour before surgery
16160249|NCT01701921|Drug|pregabalin 150 mg|pregabalin 150mg by mouth one hour before surgery
16160250|NCT01701921|Drug|Placebo|Sugar pill designed to mimic pregabalin capsule, by mouth one hour before surgery
16160251|NCT01701882|Drug|tenofovir/emtricitabine/rilpivirine|
16160252|NCT01701856|Drug|Interferon beta-1b|250 mcg, s.c., each other day for 12 months
16160253|NCT01701843|Drug|Cromoglicate|Twice daily topical treatment for 14 days
16160254|NCT01701843|Drug|Placebo|Twice daily topical treatment for 14 days
16160255|NCT01701817|Other|Patients with Atrial Fibrillation|Treatment patterns of AF according to patient demographics, clinical factors, risk stratification, and geographic regions.
16160256|NCT01701804|Drug|Chuna herbal medicine|120ml of Chuna herbal medicine(Ostericum koreanum, Eucommia ulmoides, Acanthopanax Sessiliflorus, Achyranthes bidentata, Psoralea corylifolia, Peucedanum japonicum, Cibotium barometz, Lycium chinense, Boschniakia rossica, and Cuscuta chinensis) taken twice a day 30 minutes after meals for 16 weeks
16160257|NCT01701804|Procedure|Chuna manual therapy|A type of Korean spinal manual therapy administered 5~10 minutes at physician's discretion once a week for 16 weeks. Applies mobilization using High-Velocity, Low-Amplitude thrusts to joints slightly beyond the passive ROM and manual force within the passive ROM without thrusts.
16160258|NCT01701804|Procedure|Acupuncture|Acupuncture using sterilized disposable needles, sized 0.30X40 mm. Needles left for 15~20 minutes, selecting 6 acupoints(both BL23, BL24, BL25) and other acupoints at physician's discretion, using a total of 10~20 acupoints once a week for 16 weeks.
16161459|NCT01692015|Other|Questionnaire on nosebleed severity|
16160259|NCT01701804|Procedure|Bee-venom pharmacoacupuncture|Bee-venom pharmacoacupuncture using 30G sterilized bee venom. Selecting 6 acupoints(both BL23, BL24, BL25) and other acupoints at physician's discretion, concentration 10,000:1, 0.1 cc per acupoint, total amount injected 1.0 cc/session once a week for 16 weeks.
16160260|NCT01701791|Other|Computerized Decision Support System|
16160261|NCT01701778|Drug|Caudal Dexmedetomidine|"Caudal: Levobupivacaine 0.25% 1ml/kg and dexmedetomidine 1µg/kg
~Intravenous: 10 ml normal saline"
16160262|NCT01701778|Drug|Intravenous Dexmedetomidine|"Caudal: Levobupivacaine 0.25% 1ml/kg
~Intravenous: dexmedetomidine 1µg/kg"
16160263|NCT01701778|Drug|Placebo|"Caudal: Levobupivacaine 0.25% 1ml/kg
~Intravenous: 10 ml normal saline"
16160264|NCT01701778|Drug|sevoflurane|Induction and maintain anaesthesia
16160265|NCT01701752|Biological|FP-01.1 + Placebo|
16160266|NCT01701752|Biological|FP-01.1 + TIV|
16160267|NCT01701752|Biological|FP-01.1-Adjuvant + Placebo|
16160268|NCT01701752|Biological|FP-01.1-Adjuvant + TIV|
16160269|NCT01701752|Biological|Adjuvant + TIV|
16160270|NCT01701752|Biological|Placebo + TIV|
16160271|NCT01701752|Biological|FP-01.1|
16160272|NCT01701752|Biological|FP-01.1-Adjuvant|
16160273|NCT01701752|Other|Placebo|
16160274|NCT01701739|Drug|aleglitazar|Multiple doses of aleglitazar
16160275|NCT01701739|Drug|digoxin|Single dose of digoxin
16160276|NCT01701726|Other|acupuncture|In each session, acupuncture are applied bilaterally. Except the acupoints around the neck(ST9.GB20.non-acupoints 4) ,6 auxiliary needles will be punctured at 2mm lateral to each acupoints or non-acupoints.as to auxiliary needle we will not do any manipulation. We use transcutaneous electric acupoints stimulation to stimulate the acupoints and non-acupoints.
16160277|NCT01701726|Other|Sham acupuncture|In contrast to acupuncture, sham acupuncture is given at 4 sham points with skin penetration. Electroacupuncture is also applied.
16160278|NCT01701713|Device|DKI ED2011|
16160279|NCT01701713|Device|Sham-TDCS|
16160280|NCT01701700|Procedure|portable electronic magnifier|
16160281|NCT01701700|Procedure|optical aids|
16160282|NCT01701674|Drug|Ipilimumab|Pre-treatment with ipilimumab (cycle 1): Before the participant's tumor sample is taken to send to the lab for growing the TILs, they will start their first cycle of ipilimumab. This drug is given as an intravenous infusion (through a vein) over a period of about 90 minutes (an hour and a half). Cycle 2 of ipilimumab: About a week after the sample of the participant's tumor was collected for TIL growth (and 3 weeks after their first cycle of ipilimumab), participants will have their second cycle of ipilimumab. This will be another IV infusion, lasting about 90 minutes.
16160283|NCT01701674|Procedure|Tumor Infiltrating Lymphocytes (TIL)|Tumor sample for TIL growth in the lab: About 2 weeks after the participant's first cycle of ipilimumab, a sample of their tumor will be collected and sent to the lab for TIL growth. Growing the TILs takes about 6 weeks. If their sample has grown enough TIL cells, participants will continue with the next part of the study. Depending on how long the TILs take to grow in the lab, they may need to repeat some of their laboratory and imaging tests (blood draws, X-rays, and CT or magnetic resonance imaging [MRI] scans). TIL Infusion (inpatient): After completing lymphodepletion, participants will be admitted back into the hospital for IV infusion of the TIL cells.
16160284|NCT01701674|Drug|Administration of Lymphodepletion|Lymphodepletion (inpatient hospital stay for about 2 days plus outpatient drug dosing for 5 days): About 4 weeks after their second cycle of ipilimumab, participants will be admitted to the hospital for their first two days of receiving the chemotherapy drug, cyclophosphamide. This drug will be given as an intravenous (IV, meaning through the vein) infusion. After 2 days of receiving cyclophosphamide, if their study doctor thinks that they are well enough, you will be discharged from the hospital and will return for the next 5 days in a row for outpatient IV infusions of the second lymphodepletion chemotherapy, fludarabine.
16160285|NCT01701674|Drug|Cyclophosphamide as Part of Lymphodepletion|
16160286|NCT01701674|Drug|Fludarabine as Part of Lymphodepletion|
16160287|NCT01701674|Drug|High Dose IL-2|High dose IL-2 (continued inpatient): Participants will remain in the hospital following TIL infusion for receiving high dose IL-2 and recovery. The IL-2 will be given three times per day for about 3-5 days as an IV bolus (meaning through the vein, more quickly than other infusions - in about 15 minutes each dose). Participants will remain in the hospital for approximately 7-14 days until they have recovered from the IL-2 treatments.
16160288|NCT01701674|Biological|Adoptive Cell Therapy with TIL|
16160289|NCT01701661|Procedure|Operative treatment|stripping of main trunk or if previously removed, removal or ligating the refluating trunk
16160290|NCT01701661|Other|conservative treatment|Compression stockings class II
16160291|NCT01701648|Other|Laser CO2|Transplantation of autologous melanocytes using amniotic membrane as a substrate. Transplantation of suspension of autologous melanocytes.
16160292|NCT01701635|Behavioral|Disclosure intervention|An adherence and disclosure specialist will meet with caregiver-child dyad at each clinic visit and provide caregiver information and skills for HIV disclosure till the caregiver discloses the HIV status to the child.
16160293|NCT01701635|Behavioral|usual care|An adherence and disclosure specialist will meet with caregiver-child dyad at each clinic visit and provide caregiver with general health information without referencing HIV disclosure in their conversations till the caregiver discloses the HIV status to the child.
16160294|NCT01701622|Drug|febuxostat|"If baseline allopurinol dose < 300 mg daily, will initiate febuxostat 40 mg daily.
~If baseline allopurinol dose > 300 mg daily, will initiate febuxostat 80 mg daily.
~Febuxostat is to be continued for 4 weeks, with blood pressure assessments by clinic and ambulatory blood pressure measurement at baseline and after 4 weeks."
16160295|NCT01701609|Behavioral|Cognitive Remediation Therapy|
16160296|NCT01701596|Procedure|Immediate rotational atherectomy (RA)|Immediate RA in the treatment with nondilatable calcified lesion complicated by coronary dissection.
16160297|NCT01701596|Procedure|Delayed rotational atherectomy (RA)|Delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection
16160298|NCT01701583|Drug|Omalizumab|Patients will receive omalizumab 300mg subcutaneously every 4 weeks for 12 weeks at the study center.
16160299|NCT01701570|Behavioral|Placebo Attention Control|The placebo attention control group will receive weekly phone calls to monitor their blood glucose levels.
16161460|NCT01692015|Other|One week food diary generated by weighing foods|
16160300|NCT01701570|Other|Supervised Exercise Training|The 20-week aerobic exercise training intervention provides supervised exercise training sessions 3 times weekly following the HERITAGE study training model that was feasible in prior studies with older, sedentary overweight adults (55%maximal oxygen uptake (VO2max) for 30 minutes per session at study entry with progressive titration to 70-80% VO2max for 50 minutes).
16160301|NCT01701557|Other|slow fluid rate|10 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.25 times maintenance
16160302|NCT01701557|Other|fast fluid rate|20 mL/kg of NS intravenous bolus over the first hour followed by ¾ NS with potassium replacement at 1.5 times maintenance
16160303|NCT01701544|Device|NBM DBS|Deep Brain Stimulation targeting the Nucleus Basalis of Meynert
16160304|NCT01701531|Drug|RBCPF|
16160305|NCT01701518|Drug|Ozurdex|biodegradable 0.7mg dexamethasone implant
16160306|NCT01701505|Drug|400uL of Kovacaine Mist|2 unilateral intranasal sprays of 200uL each.
16160307|NCT01701505|Drug|200uL of Kovacaine Mist|2 unilateral intranasal sprays of 100uL each.
16160308|NCT01701505|Drug|120uL of Kovacaine Mist|2 unilateral intranasal sprays of 60uL each.
16160309|NCT01701492|Other|Questionnaire|A one-time assessment using both performance-based measures as well as both self- and parent-report questionnaires.
16160310|NCT01701492|Other|Neurocognitive Evaluation|A one-time neurocognitive evaluation conducted in the Psychology Clinic
16160311|NCT01701479|Drug|ch14.18/CHO|
16160312|NCT01701479|Drug|Aldesleukin|
16160313|NCT01701479|Drug|Isotretinoin|
16160314|NCT01701466|Other|Aveeno cream|Twice a day
16160315|NCT01701466|Other|Flamazine cream|Twice a day, when there is dry desquamation
16160316|NCT01701466|Other|NeoVIDERM cream|Three times a day
16160317|NCT01701453|Drug|P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)|P2Y12 inhibitor (clopidogrel, ticagrelor, prasugrel)
16160318|NCT01701440|Device|Biofusionary Bebe|
16160319|NCT01701414|Drug|Femoral nerve block: 25 mL of 0.5% bupivacaine|25ml of 0.5% bupivacaine will be injected along the nerve sheath. The nerve block will be administered by one of the physician co- investigators all of whom are emergency physicians and all of whom have been trained in the use of ultrasound and ultrasound guided nerve blocks.
16160320|NCT01701414|Drug|Placebo: 3cc of 0.9% Normal Saline|1cm lateral to the ultrasound probe, a 27 gauge needle and syringe will be used to inject 3cc of 0.9% NS subcutaneously. The SC group will then be cared for by the Emergency Department physicians according to their regular clinical practice
16160321|NCT01701401|Drug|LDV/SOF|LDV/SOF 90/400 mg FDC tablet administered orally once daily
16160322|NCT01701401|Drug|RBV|RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16160323|NCT01701388|Device|Ekso exoskeleton|The participants will receive 1 - 40 training sessions. The sessions will be 1 hour of device use including balance training, gait training and sit to and from stand training with rolling walker and/ or forearm crutches.
16160324|NCT01701375|Drug|PD 0332991|• PD 0332991 will be given orally days 1,2,3
16160325|NCT01701362|Drug|pregabalin|capsules, 150-600 mg/day administered in divided doses twice a day for 15 weeks after randomization
16160326|NCT01701362|Drug|placebo|capsules, placebo for pregabalin administered in divided doses twice a day for 15 weeks after randomization
16160327|NCT01701349|Drug|Fosbretabulin + paclitaxel + carboplatin|Fosbretabulin 200 mg/m2 IV infusion
16160328|NCT01701349|Drug|Placebo + paclitaxel + carboplatin|Paclitaxel 200 mg/m2, Carboplatin AUC 6 IV infusion
16160329|NCT01701336|Biological|Ad6NSmut, MVA-NSmut|2 doses Ad6NSmut at week 0 and 4, then 2 doses of MVA-NSmut at weeks 8 and 12. PEG-IFN/RBV therapy starts at week 10 after first vaccination
16160330|NCT01701323|Biological|Ex-Vivo Expanded Cord Blood Progenitor Cell Infusion|Given IV
16160331|NCT01701323|Drug|Cytarabine|Given IV
16160332|NCT01701323|Drug|Filgrastim|Given SC or IV
16160333|NCT01701323|Drug|Fludarabine Phosphate|Given IV
16160334|NCT01701310|Drug|Ferric carboxymaltose|A minimum of 1 dose of 1000mg of intravenous ferric carboxymaltose will be administered at least 14 days prior to the date of operation.
16160335|NCT01701310|Drug|Ferrous Sulphate|(Control) 200mg twice a day of oral ferrous sulphate will be administered for a minimum of a two week period
16160336|NCT01701297|Drug|cotrimoxazole|Cotrimoxazole 960mg orally each day (two 480mg tablets)
16160337|NCT01701297|Drug|VSL#3 active|The prescribed dose was 2 sachets (containing 900 billion bacteria) orally each day for 48 weeks
16160338|NCT01701297|Drug|VSL#3 placebo|This was two placebo sachets identical to VSL#3 active sachet. The prescribed dose was 2 sachets orally each day for 48 weeks
16160339|NCT01701284|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|
16160340|NCT01701271|Other|Hair loss prevention lotion|For greatest problems 20 drops on the scalp per day for 3 months. For minor problems 10 drops on the scalp three times per week for 3 months.
16160341|NCT01701258|Drug|Amisulpride|single low-dose pharmacological challenge, 50 mg amisulpride during the fMRI session only
16160342|NCT01701258|Drug|Placebo|single-dose placebo capsule during the fMRI session only
16160343|NCT01701245|Device|GammaCore|vagal stimulation
16160344|NCT01701232|Biological|rituximab|Patients will receive rituximab at a dose of 375 mg/m2 intravenously once a week for 4 weeks (on day 1,8,15,22)
16160345|NCT01701219|Drug|Ceftaroline fosamil|Ceftaroline fosamil 600 mg intravenous (IV) infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour) (dosing may be adjusted for renal function)
16160346|NCT01701206|Behavioral|HIV knowledge Intervention|
16160347|NCT01701193|Drug|L-Alanyl/L-Glutamine|Sterile solution of L-Alanyl-L-Glutamine, 400mg/mL in water for injection. It is dosed at 1g/kg of body weight and is instilled into the peritoneum at the time of surgery. The active ingredient, glutamine, is a conditionally essential amino acid component of nutritional supplements.
16160348|NCT01701193|Drug|Physiologic saline|Placebo
16160349|NCT01701180|Drug|Oxytocin|24 IU; 3 puffs per nostril, each with 4 IU OXT
16160350|NCT01701180|Drug|Placebo|
16160351|NCT01701154|Other|respiratory muscle strength training|
16160599|NCT01699282|Behavioral|conventional hospital education|Group thorough VKA education V.S. control group (conventional hospital education)
16160352|NCT01701128|Other|Walking on treadmill|3 sessions/week, 24 weeks. The heart rate does not exceed 75% of maximum heart rate (220-age) of the participant and that blood pressure does not exceed 250/115 mmHg. During the first week, the TT velocity was adjusted to 80% of preferential walking speed of the participant. The following week, the participant was encouraged to reach 90% and 100% in the third week. From the fourth week, subjects in the Speed TT had an increase in speed, depending on exercise tolerance of each participant. The TT velocity was increased by 0,2 km/h when the participant reached criteria.
16160353|NCT01701128|Other|Walking on treadmill|3 sessions/week, 24 weeks. The heart rate does not exceed 75% of maximum heart rate (220-age) of the participant and that blood pressure does not exceed 250/115 mmHg. During the first week, the TT velocity was adjusted to 80% of preferential walking speed of the participant. The following week, the participant was encouraged to reach 90% and 100% in the third week. From the fourth week, the TT velocity was increased by 0,2 km/h or the incline of the walking surface of TT was increased by 1% alternately when the progression criteria were met.
16160354|NCT01701128|Other|Control group|Training of the control group was characterized by light intensity exercises. For the first three months, participants performed regular exercise involving full range of motion to enhance their flexibility. For the last three months of the training programme, participants learned elements of Tai Chi and rhythmic movements of latin dance. Participants attended two 1-h supervised sessions per week and were asked to perform each week a third session at home, based on instructions in a document offered to the control group participants
16160355|NCT01701115|Procedure|Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block|"Anesthetic volume:
~Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL"
16160356|NCT01701115|Procedure|Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block|"Anesthetic volume:
~Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL"
16160357|NCT01701115|Drug|Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)|
16160358|NCT01701115|Drug|Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)|
16160359|NCT01701102|Procedure|Mepivacaine (24 mg) plus fentanyl|Mepivacaine (24 mg) and fentanyl (10 µg)
16160360|NCT01701102|Procedure|Mepivacaine (27 mg) plus fentanyl|Mepivacaine (27 mg) and fentanyl (10 µg)
16160361|NCT01701102|Procedure|Mepivacaine (30 mg) plus fentanyl|Mepivacaine (30 mg) and fentanyl (10 µg)
16160362|NCT01701102|Procedure|Mepivacaine|Mepivacaine 37.5 mg
16160363|NCT01701089|Drug|11C-L-deprenyl-D2|Intravenous injection of 11C-L-deprenyl-D2 before positron emission tomography (PET); up to 3 injections in total
16160364|NCT01701089|Drug|RO4602522|Multiple doses of RO4602522 for 14 days
16160365|NCT01701089|Drug|RO4602522|Multiple doses of RO4602522 for up to 17 days
16160366|NCT01701076|Drug|Bendamustine|"Induction treatment phase (cycle 1-6):
~Bendamustine 75 mg/m2 i.v day 1 and 2
~Lenalidomide 25 mg p.o. day 1-21
~Dexamethasone 40/20 mg p.o., day 1, 8, 15, 22
~Pegfilgrastim 6 mg s.c., day 3 in case of severe neutropenia
~Maintenance treatment phase (cycles 7-18):
~Lenalidomide 25 mg p.o. day 1-21
~Dexamethasone 40/20 mg p.o., day 1, 8, 15, 22"
16160367|NCT01701063|Drug|Telaprevir|100- and 250-mg chewable tablets or 375-mg film-coated tablets for oral administration
16160368|NCT01701063|Drug|Peginterferon alfa-2b|50 μg/0.5 mL, 80 μg/0.5 mL, 120 μg/0.5 mL, or 150 μg/0.5 mL for subcutaneous (SC) injection
16160369|NCT01701063|Drug|Ribavirin|200-mg capsules or 40-mg/mL solution for oral administration
16160370|NCT01701050|Other|Blood collection|Patients will have blood drawn for circulating tumor cell (CTC) endocrine therapy index (CTC-ETI) calculation at baseline (within 30 days prior to the initiation of endocrine therapy) and then subsequently 1, 2, 3 and up 12 months after the initiation of therapy, or at the time of disease progression, whichever occurs first.
16160371|NCT01701037|Drug|dabrafenib|150 mg given PO
16160372|NCT01701037|Drug|trametinib|2 mg given PO
16160373|NCT01701037|Other|laboratory biomarker analysis|Correlative studies
16160374|NCT01701024|Drug|ACYC|ACYC active, topically applied to the face for 12 weeks
16160375|NCT01701024|Drug|ACYC vehicle|ACYC vehicle (placebo), topically applied to the face for 12 weeks
16160376|NCT01701011|Behavioral|Coping intervention|Positive reappraisal coping intervention
16160377|NCT01700998|Drug|Magnesium|
16160378|NCT01700998|Drug|Placebo|
16160379|NCT01700985|Drug|122-0551|Applied twice daily for two weeks
16160380|NCT01700985|Drug|Vehicle|Applied twice daily for two weeks
16160381|NCT01700972|Procedure|Myocardial perfusion imaging|The radionuclide Myoview will be administered once for the rest and stress myocardial perfusion imaging. The subsequent rest and stress imaging will be performed twice each - at 10 minutes and 30-45 minutes after radiotracer injection.
16160382|NCT01700959|Drug|melatonin|Melatonin 3mg time release will be given. Participants will be instructed to take one 3mg time released tablet by mouth approximately 1-2 hours before initiating sleep onset, preferably at the same time each night.
16160383|NCT01700959|Drug|placebo|Placebo tablets to match the melatonin will be comprised of inert substances.
16160384|NCT01700946|Drug|dexamethasone|given intravenously or orally
16160385|NCT01700946|Drug|vincristine sulfate|given intravenously
16160386|NCT01700946|Biological|rituximab|given intravenously
16160387|NCT01700946|Drug|clofarabine|given intravenously
16160388|NCT01700946|Drug|cyclophosphamide|given intravenously
16160389|NCT01700946|Drug|etoposide|given intravenously
16160390|NCT01700946|Biological|aldesleukin|given subcutaneously
16160391|NCT01700946|Drug|pegaspargase|given intravenously
16160392|NCT01700946|Drug|methotrexate|given intrathecally or intravenously
16160393|NCT01700946|Drug|mercaptopurine|given orally
16160394|NCT01700946|Drug|cytarabine|given intrathecally or intravenously
16160395|NCT01700946|Drug|mitoxantrone|given intravenously
16160396|NCT01700946|Drug|teniposide|given intravenously
16160397|NCT01700946|Drug|vinblastine|given intravenously
16160398|NCT01700946|Biological|natural killer cell infusion|undergo allogeneic natural killer cell infusion
16160399|NCT01700946|Other|laboratory biomarker analysis|correlative studies
16160400|NCT01700946|Drug|therapeutic hydrocortisone|given intrathecally
16160401|NCT01700946|Procedure|allogeneic hematopoietic stem cell transplantation|undergo allogeneic HSCT
16160402|NCT01700946|Device|CliniMACS|The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells.
16160403|NCT01700933|Other|High-Dosage Exercise Therapy|"Structure of the exercise program done three times per week, for eight weeks:
~5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 30 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 30 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.)"
16160404|NCT01700933|Other|Low-Dosage Exercise Therapy|"Structure of the exercise program done three times per week, for eight weeks:
~5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 10 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.) Four local exercises (3 series of 10 repetitions) 5-10 minutes of global exercise (cycling, walking on treadmill etc.)"
16160405|NCT01700920|Procedure|bone marrow aspirate|
16160406|NCT01700907|Drug|Desflurane|The patients in this arm will be given the general anesthesia with desflurane and be used the Aysis as the anesthetic machine.
16160407|NCT01700907|Drug|Sevoflurane|The patients in this arm will be given the general anesthesia with sevoflurane and be used the Aysis as the anesthetic machine.
16160408|NCT01700894|Behavioral|Walking Program + Motivational Interviewing Calls|
16160409|NCT01700894|Behavioral|Walking Program + Automated Calls|
16160410|NCT01700894|Behavioral|Walking Program|
16160411|NCT01700881|Other|Plant-based diet|Weekly instructions will be given to the participants in the intervention group about following vegan diet.
16160412|NCT01700881|Other|Supplement|Unrestricted diet with clinically insignificant amount of omega- 3 oils and vitamin E
16160413|NCT01700868|Other|Vegan diet|A diet devoid of any animal products. Low-fat, low-Glycemic Index, vegan diet.
16160414|NCT01700868|Other|American Diabetes Association guidelines|Participants will follow individualized diet plans following ADA guidelines
16160415|NCT01700855|Procedure|non-electroacupuncture|The same procedure as electroacupuncture except stimulation
16160416|NCT01700855|Procedure|Electroacupuncture|"Electrodes are applied to bilateral Hegu(L14) acupoints at the time of 1h before operation, and connected to Hwato Electronic Acupuncture Treatment Instrument (Model No. SDZ-V, Suzhou Medical Appliances Co., Ltd., Suzhou, China). The acupoints are stimulated at an intensity of 3~6 mA and a frequency of 2/30 Hz for 30 min. The highest intensity will be chosen at which the patient can tolerate."
16160417|NCT01700829|Drug|Ketamine|Single dose of 0.5 mg/kg of ketamine given intravenously (in the vein) over 40 minutes
16160418|NCT01700829|Drug|Midazolam|Single dose of 0.02 mg/kg of Midazolam given intravenously (in the vein) over 40 minutes
16160419|NCT01700816|Device|Bright light therapy|The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.
16160420|NCT01700816|Device|Sham light|The light box will be placed vertically on a patient table or bed side 2.5 feet away from the user's eyes daily from 8 am to 8:30 am.
16160421|NCT01700803|Drug|Povidone Iodine 10% vand cesarean section wound infections|
16160422|NCT01700803|Drug|Povidone Iodine 7.5% vand cesarean section wound infections|
16160423|NCT01700790|Drug|Lopinavir/ritonavir and ritonavir|Two tablets twice daily of Lopinavir/ritonavir 200 mg/50mg with 3 capsules of ritonavir 100 mg twice daily given with rifampin 600 mg daily
16160424|NCT01700777|Other|"HABIT-ILE"|"90 h of training with HABIT-ILE, in an intensive rehabilitation camp compared with a regular therapy program (groups are crossed-over afterwards)."
16160425|NCT01700751|Drug|brentuximab vedotin|
16160426|NCT01700738|Procedure|gastric ring surgery|
16160427|NCT01700738|Other|nutritional help|
16160428|NCT01700725|Other|Nasal Irrigation - Saline|"Liquid-based nasal irrigation (NI) is performed using a nasal irrigation cup (neti pot), a simple hand-held vessel that uses the force of gravity to gently irrigate the user's nasal cavity. Subjects will be requested to perform NI twice daily. The subjects will prepare the saline solution by themselves using the study-provided kit which will include packets of salt powder and the neti pot; subjects will dissolve the powder in lukewarm tap water to achieve a 2% buffered saline solution. The solution is then delivered to the nasal cavity using neti pot."
16160429|NCT01700725|Drug|Nasal Irrigation - Xylitol|"Liquid-based nasal irrigation (NI) is performed using a nasal irrigation cup (neti pot), a simple hand-held vessel that uses the force of gravity to gently irrigate the user's nasal cavity. Subjects will be requested to perform NI twice daily. The subjects will prepare the Xylitol solution by themselves using the study-provided kit which will include packets of Xylitol powder and the neti pot; subjects will dissolve the powder in lukewarm tap water to achieve a 5% Xylitol solution. The solution is then delivered to the nasal cavity using neti pot."
16160430|NCT01700712|Dietary Supplement|Probiotic Lactobacilli reuteri|
16160431|NCT01700712|Dietary Supplement|Placebo|
16160432|NCT01700686|Other|Meal test and dexa scan|Body composition is determined by whole body deca scan and bone mineral density is determined dy dexa scans of the lumbar spine and the proximal femur.
16160433|NCT01700673|Drug|Azacitidine|Azacitidine will be administered days 1-5 of a 28 day cycle. Treatment is planned for a total of 12 cycles.
16160434|NCT01700673|Biological|Sargramostim|Sargramostim will be administered days 1-10 of a 28 day cycle. Treatment is planned for a total of 12 cycles.
16160435|NCT01700647|Other|Breath test- sampling using ENose|Patients give a sample of breath ( slow vital capacity breath, collected in Tedlar bag and immediately analysed and discarded)
16160436|NCT01700647|Other|Laryngoscopy and bronchoscopy|Detailed assessment of larynx and bronchus mucosa including autofluoresecence to fully define dysplasias if present or exclude them.
16160437|NCT01700621|Biological|Rotarix vaccine|one 1.0 ml dose of oral rotavirus vaccine at 9 months of age
16160438|NCT01700621|Biological|measles-rubella vaccine|one 0.5 ml subcutaneous dose of live attenuated measles-rubella vaccine
16160439|NCT01700608|Drug|plerixafor|plerixafor 240 mcg/kg/day at the hematopoietic recovery after chemotherapy
16160598|NCT01699282|Behavioral|VKA (antivitamin K) education|Evaluate benefits of a comprehensive patient education on oral anticoagulant compared to conventional hospital education
16160440|NCT01700595|Procedure|new technical intervention|Contractures and broad scars of the subjects are treated by this surgical intervention which is a reconstructive surgery that is performed by the transfer of preexpanded perforator flaps to the recipient sites of skin deficiency.
16160441|NCT01700569|Drug|Temozolomide|All the Patients are treated by oral Temozolomide 75 mg/m²/day every day during 42 days, 30 minutes after Folinic acid and 120 min before the radiation dose to the brain tumor. After one month rest, the maintenance phase consists of:Temozolomide is given orally (30 min after Folinic acid), at 200 mg/m²/day every day during 5 days: one course every month during 6 months (6 maintenance course).
16160442|NCT01700569|Drug|folinic acid at pharmacological dose is the escalated drug|
16160443|NCT01700569|Radiation|High voltage radiation therapy (linear accelerator)|Brain tumor field is irradiated Five days a week, during Stupp regimen during 6 weeks. During the sams time, Folinic acid and Temozolomide are given orally every days (six weeks).
16160444|NCT01700556|Other|Case Manager|"The following support will be provided by a case manager:
~At least 3 sessions of individual face-to-face counselling (housing arrangements, disease awareness, problem solving) consisting of an initial and two reinforcing sessions four and eight months after enrollment.
~Monthly follow-up telephone calls. Stress management training of the family caregiver and some practical items for management of patient care in the home.
~Information about services/aid/certification/subsidies offered by the National Health Service, by municipal social services and by local voluntary organizations. Information on health services, support connecting to GPs and health service units (medical specialists, hospital services) and social services (municipal offices and public offices of any capacity)."
16160445|NCT01700556|Other|Assistive Technologies|The technologies to be employed are devices already widely used and marketed, are simple to use and do not require high technical expertise for installation and maintenance. The devices will be assigned to subjects in the UP-TECH treatment group after an evaluation of the home, made by the case manager. Such technologies include e.g.: access facilitated telephone, timed drug dispenser, and housing adaptations such as anti-slip strips; home leaving sensors; sensors to detect night falls; Gas and water leak sensors, and automatic lights.
16160446|NCT01700556|Other|light support|An information package illustrating the range of social and health services available in local community will be created. It will be delivered to the caregiver during home visits by the nurse.
16160447|NCT01700556|Other|3 preventive home visits by a nurse|The dyads will receive three home visits by a specifically trained nurse. Home visits will occur at enrollment and after 6 and 12 months. Each visit will occur with the following steps: telephone contact between the nurse and the family caregiver, a home visit comprising the administration of the UP-TECH questionnaire, counselling/training of the caregiver regarding patient assistance, feeding, ergonomics of the home environment, covers practical aspects of patient assistance, such as daily management of drug treatment, ergonomics of the home environment, stress management and care burden. In order to provide this information to the caregiver, the nurses will receive a specific training course.
16160448|NCT01700543|Procedure|Shoulder Arthroplasty|Implantation of the Sidus Stem-Free Shoulder follows standard shoulder replacement procedures.
16160449|NCT01700530|Drug|Statin|Statins (40mg/day)for 12 weeks
16160450|NCT01700530|Other|Exercise only|12 weeks of exercise training (5 days a week for 45-50 min a session)
16160451|NCT01700530|Other|Statins + Exercise|Statins (40mg/day of simvastatin) plus exercise training (5 days/wk for 45-50 min a session) for 12 weeks
16160452|NCT01700517|Other|Spinal anesthesia|spinal anesthesia
16160453|NCT01700517|Other|Femoral nerve block|Femoral nerve block
16160454|NCT01700517|Other|sciatic nerves block|sciatic nerves block
16160455|NCT01700504|Drug|Axillary lavage with gentamicin solution|Patients undergoing an axillary lavage with 500ml of normal saline followed by 500ml gentamicin solution
16160456|NCT01700491|Drug|Epidural Catheter 0.2% ropivacaine|0.2% ropivacaine into epidural space and saline into paravertebral space
16160457|NCT01700491|Drug|Paravertebral Catheter 0.4% ropivacaine|0.4% ropivacaine into paravertebral space and saline into the epidural space
16160458|NCT01700478|Drug|Misoprostol + vasopressin|400ug of misoprostol is given per rectum, one hour prior to surgery. Vasopressin is used at the time of surgery.
16160459|NCT01700478|Drug|Vasopressin|Vasopressin was used in all patients during surgery.
16160460|NCT01700439|Device|EDWARDS INTUITY valve|Surgical replacement of the aortic valve with the EDWARDS INTUITY valve.
16160461|NCT01700426|Drug|Vitamin E|A commercial Vitamin E preparation (Aqueous Vitamin E®, 15 IU/0.3 ml; SilaRx, Inc, Spring Valley, NY) will be used for the study, also on the recommendation of the Children's Hospital Colorado (CHC) research pharmacist. The Vitamin E dose will be 18 mg/day for all subjects randomized to the Vitamin E group.
16160462|NCT01700426|Other|Placebo|The control group will receive an indistinguishable placebo preparation, which will be compounded by the CHC research pharmacy using the following inactive ingredients: purified water, polysorbate 80, sorbital, and propylene glycol. This suspension is stable for 6 months.
16160463|NCT01700413|Drug|Idarubicin|
16160464|NCT01700400|Drug|Everolimus|
16160465|NCT01700400|Drug|Pemetrexed|
16160466|NCT01700400|Drug|Carboplatin|
16160467|NCT01700400|Drug|Bevacizumab|
16160468|NCT01700387|Drug|onabotulinumtoxinA|All subjects will receive a minimum dose of 155 U Botulinum Toxin Type A Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven (7) specific head/neck muscle areas at Visits 2-5.
16160469|NCT01700387|Drug|Topiramate|"Subjects randomized to the onabotulinumtoxinA + topiramate group will receive:
~Week 1: topiramate 25 mg qhs Week 2: topiramate 25 mg bid Week 3: topiramate 25 mg q am + topiramate 50 mg qhs Week 4: topiramate 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period."
16160470|NCT01700387|Drug|Placebo|"Subjects randomized to the onabotulinumtoxinA + placebo group will receive:
~Week 1: placebo 25 mg qhs Week 2: placebo 25 mg bid Week 3: placebo 25 mg q am + placebo 50 mg qhs Week 4: placebo 50 mg bid Only one dosage adjustment (increase or decrease), based on efficacy or tolerability, may be made at the investigator's discretion. Subjects must maintain a dose of at least 50 mg/day to remain in the Treatment Period."
16160471|NCT01700348|Device|Airflosser|Use of Philips Airflosser
16160472|NCT01700348|Device|Manual Floss|Active Comparator
16223502|NCT01211951|Drug|Placebo|
16160473|NCT01700335|Drug|SyB L-1101|"SyB L-1101（rigosertib sodium） will be administered to two cohorts at either 1200 mg/day or 1800 mg/day.
~The dose will be administered intravenously for 72 continuous hours (3 days), followed by 11-day observation period. The treatment period of 14 days (3 days of administration + 11 days of observation) constitutes 1 cycle.
~The study will involve treatment through the second cycle, but treatment can be continued for 3 or more cycles if conditions for continued administration are satisfied."
16160474|NCT01700322|Procedure|Coronary stenting|All patients will receive a drug eluting stent as clinically indicated.
16160475|NCT01700322|Drug|Ticagrelor|Ticagrelor 180mg oral loading dose and 90mg b.i.d for 30 days following coronary artery stenting
16160476|NCT01700322|Drug|Clopidogrel|Clopidogrel 600mg loading dose + 75 mg once a day for 30 days following coronary artery stenting.
16160477|NCT01700322|Drug|Prasugrel|Prasugrel 60mg oral loading dose followed by 10mg once a day for 30 days following coronary artery stenting
16160478|NCT01700309|Behavioral|Young and Active|The intervention will consist of three meetings between the adolescent, the parents and the researchers, and weekly web-based health-counselling. The adolescents will set goals and make an individual activity plan on the web-page. During the study period all activity will be registered by the adolescents. The researchers will perform weekly counseling based on Selfdetermination Theory and Motivational Interviewing. The webiste also allows for the adolescents to communicate with eacother and with the counsler through a blog.
16160479|NCT01700296|Behavioral|Best care|"Best Care: subjects are randomly assigned to the Best care regardless MRC class and severity of symptoms through:
~10 weeks of rehabilitation (2 hours, 2 times a week) by Region Zealand's instructions on sundhed.dk. COPD rehabilitation includes physical exercise, smoking cessation, medication, nutrition education and psychosocial support and patient education. Rehabilitation provided by a multidisciplinary effort with lung nurse, dietician and physiotherapist according to national and international guidelines (1.5) (6) (24) (25)
~Outpatient follow-up every 3 months, a total of 5 visits, and during these visits various subjective, clinical, paraclinical and invasive parameters."
16160480|NCT01700283|Behavioral|exercise education and walking program|12-week moderate intensity walking program
16160481|NCT01700270|Drug|dovitinib (TKI258)|
16160482|NCT01700270|Drug|fluvoxamine|perpetrator drug; 7 days of dosing
16160483|NCT01700257|Radiation|CT scan & Early CDT Lung test|
16160484|NCT01700257|Other|CT scan & Early CDT Lung test|
16160485|NCT01700244|Device|Pacemaker implant|
16160486|NCT01700231|Procedure|Liver resection|Liver resection of patient with neoplastic hepatic tumors
16160487|NCT01700218|Other|telemonitoring|
16160488|NCT01700218|Other|control|
16160489|NCT01700205|Other|Type of Formula|infant formula
16160490|NCT01700192|Biological|MK-8237 tablets|MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d.
16160491|NCT01700192|Biological|Placebo tablets|Placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d.
16160492|NCT01700192|Drug|Rescue Medication: Self-Injectable Epinephrine|Self-injectable epinephrine (preferred dose of 0.30 mg) administered intramuscularly as needed for rescue medication.
16160493|NCT01700192|Drug|Rescue Medication: Loratadine tablets|Loratadine tablet 10 mg administered orally as needed for rescue medication.
16160494|NCT01700192|Drug|Rescue Medication: Olopatadine ophthalmic drops|Olopatadine hydrochloride ophthalmic drops 0.1% administered as needed for rescue medication.
16160495|NCT01700192|Drug|Rescue Medication: Mometasone furoate nasal spray|Mometasone furoate monohydrate nasal spray 50 mcg administered intranasally as needed for rescue medication.
16160496|NCT01700179|Drug|ACH-0143102|
16160497|NCT01700179|Drug|Ribavirin|
16160498|NCT01700166|Biological|Autologous Human Cord Blood derived Stem Cell injection|One time intravenous (in the vein) injection with two year follow-up
16160499|NCT01700153|Other|Robotic-assisted therapy|This robotic device is designed to intensively rehabilitate the upper limb. Indeed, this robot allows the patient to perform a lot of active, passive, or assisted exercises. The level of assistance is determined and provided by the robot in function of the patient capacity.
16160500|NCT01700153|Other|Classical therapy|conventional therapy will be performed by therapists specialized in neuro-pediatric rehabilitation
16160501|NCT01700140|Drug|SyB D-0701|Study drug patches [Low dose group (18.75 mg): SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 patch, High dose group (30.00 mg): SyB D-0701 15 cm2 patch + SyB D-0701 25 cm2 patch] assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
16160502|NCT01700140|Drug|Placebo|Study drug patches (Placebo group: SyB D-0701 15 cm2 placebo patch + SyB D-0701 25 cm2 placebo patch) assigned at the Case Registration Center are applied to either the right or left upper arm at 12 to 24 hours prior to the start of radiotherapy and left as is until 24 hours after completion of the third irradiation.
16160503|NCT01700127|Other|Breastfeeding|breastfeeding encouraged versus withheld
16160504|NCT01700114|Device|MelaFind|The device is used when a dermatologist chooses to obtain additional information on atypical skin lesions for a decision to biopsy.
16160505|NCT01700075|Drug|Conventional treatment|"Lipidlowering: Atorvastatin (Liprimar) - 40mg per day. Antihypertensive: Diroton (Lisinopril, Gedeon Richter Ltd) - 10mg twice per day and Ditiazem (calcium bloker from the benthodiazepines, Lannacher, Austria) - 90mg per day.
~Antihyperglycemic drugs: biguanides Metformin - 0.5 g two or tree times per day, or Exenatide - 5-10 µg per day.
~Anti-inflammatory: TromboACC (acetylsalicylate acid) up to 2 g per day and/or Clopidogrel (thienopyridine class antiplatelet agent) - 75mg per day."
16160506|NCT01700075|Dietary Supplement|Weight loss treatment|Weight loss treatment by administering a healthy very low-calorie, low-fat vegetables and salt diet and includes an adjustment and modify eating behavior and increased physical activity.
16160507|NCT01700062|Dietary Supplement|Total Parenteral Nutrition (TPN)|Medium calorie ,Nonprotein calories 20 Kcal/Kg/day,Protein 1g/Kg,Fat emulsion 0.5 g/kg/day D1-D6 post OP standard calorie, Nonprotein calories 30 Kcal/Kg/day,Protein 1.5 g/Kg,Fat emulsion 50g/day D1-D6 post OP
16160508|NCT01700049|Drug|vismodegib (150 mg PO daily)|Biopsies will be performed on all participants at baseline, week 12 and week 24.
16160509|NCT01700036|Drug|Alpha-1-Antitrypsin (AAT)|AAT (Zemaira) will be administered at a dose of 60mg/kg (actual weight) on D1, 4, 8, 12, 16, 20, 24, and 28. A second course of treatment will not be given.
16160510|NCT01700010|Drug|Lapatinib and Paclitaxel|"Lapatinib comes in tablet form and is taken by mouth at a dose of 1,000 mg every day. Paclitaxel will be given through the vein (IV) at a dose of 80 mg/m2 on days 1, 8, and 15 at each 28 day cycle. If cancer does not progress and study treatment can be tolerated after 6 cycles of paclitaxel and lapatinib, paclitaxel will be stopped and lapatinib will continue until disease progression, side effects cannot be tolerated, participant is removed from or withdraws from study, or for other reasons.
~Subjects with locally advanced disease who respond to treatment and are felt to be appropriate for local therapy may proceed to receive local therapy as deemed appropriate by the managing physician after a minimum of 6 cycles or upon achieving complete remission followed by an additional 2 cycles. Subjects who proceed to receive local therapy will be removed from protocol therapy. Subjects who elect not to receive or are not candidates for local therapy may continue treatment on protocol."
16160511|NCT01699997|Drug|Oxytocin|Intranasal spray with 40 IU of OXT
16160512|NCT01699997|Drug|Placebo|Intranasal spray with placebo solution
16160513|NCT01699971|Procedure|Hernia repair|Hernia repair admodum Lichtenstein with polypropylene mesh
16160514|NCT01699971|Procedure|Hernia repair|Hernia repair with Ultra Pro Hernia System (UHS)
16160515|NCT01699971|Procedure|Hernia repair|Hernia repair with Prolene Hernia System(PHS)
16160516|NCT01699958|Behavioral|Problem-solving intervention|Participants will receive 2 individual sessions teaching and reviewing problem-solving skills.
16160517|NCT01699945|Other|This is an observational study being conducted as a substudy of antoher trial.|
16160518|NCT01699932|Drug|Glimepiride+metformin (Amaryl M®) - HOE4900|"Pharmaceutical form:tablet
~Route of administration: oral"
16160519|NCT01699919|Drug|Intravenous lignocaine|Intravenous lignocaine infusion is given in intraoperative period and till one hour post surgery.
16160520|NCT01699906|Other|Diet regimen to induce weight loss|Diet regimen to induce weight loss
16160521|NCT01699893|Other|unique arm|blood, nasal swab, skin biopsy, stool samples
16160522|NCT01699867|Device|Optical coherence tomography|Optical coherence tomography was used to image ex vivo breast tissue specimens.
16160523|NCT01699854|Drug|capsaicin patch (qutenza)|
16160524|NCT01699854|Drug|Placebo|
16160525|NCT01699828|Drug|Buspirone|The buspirone will be given once as a tablet and encapsulated for blinding.
16160526|NCT01699828|Drug|Placebo|Placebo will be lactose and encapsulated for blinding. A single capsule will be given.
16160527|NCT01699815|Drug|Acetaminophen|
16160528|NCT01699802|Other|Inhaled anaesthetic agent|
16160529|NCT01699789|Other|Quality Improvement Program|The quality improvement program is an evidence-based toolkit from prior studies (see Names above) that supported team leadership, case and care management, medication management, and Cognitive Behavioral Therapy for Depression. The Case management manual supported depression screening and monitoring/tracking of outcomes; patient education and activation, care coordination, and behavioral activation and problem solving. The toolkit includes education on depression and a community health worker manual.
16160530|NCT01699789|Behavioral|Resources for Services Expert Team|The expert team consisted for RS consisted of 3 psychiatrists, a psychologist expert in Cognitive Behavioral Therapy, a nurse care manager, a community engagement specialist, a quality improvement expert, and staff support. They team offered 12 web-based seminars to each community on components of collaborative care as well as site visits to primary care clinics on clinical assessment and medication management.
16160531|NCT01699789|Behavioral|Community Engagement and Planning Council|The CEP Council was supported by a workbook developed by the overall CPIC Council that provided principles, approach, agendas, and resources for the multi-sector planning meetings. The CEP Councils met twice a month for 4-6 months to develop their plan and met monthly during implementation of trainings. The study Council supported CEP meetings. Community leaders co-led trainings with study experts to help assure sustainability. Each CEP council had $15K to defray costs of venues, materials, and consultations, while the study provided that for RS.
16160532|NCT01699776|Drug|Ivabradine|7.5 my b.id. by mouth for 12-14 weeks
16160533|NCT01699776|Drug|Digoxin|1.25 mg once a day by mouth, for 12-14 weeks.
16160534|NCT01699763|Device|Contour® NEXT LINK BGMS|Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with and without diabetes (up to 10% of subjects without diabetes were included). Performance of Contour® NEXT LINK BGMS was evaluated across the glucose range of the BGMSs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
16160535|NCT01699763|Device|OneTouch® UltraLink® BGMS|Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with and without diabetes (up to 10% of subjects without diabetes were included). Performance of OneTouch® UltraLink® BGMS was evaluated across the glucose range of the BGMSs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
16160536|NCT01699763|Device|Nova Max Link® BGMS|Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with and without diabetes (up to 10% of subjects without diabetes were included). Performance of Nova Max Link® BGMS was evaluated across the glucose range of the BGMSs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
16160537|NCT01699750|Device|Lotrafilcon B contact lenses|Silicone hydrogel contact lenses, Phase 2
16160538|NCT01699750|Device|Senofilcon A contact lenses|Silicone hydrogel contact lenses, Phase 2
16160539|NCT01699750|Device|OPTI-FREE® PUREMOIST® MPDS|Contact lens care system, Phase 2
16160540|NCT01699750|Device|BIOTRUE®|Contact lens care system, Phase 2
16160541|NCT01699750|Device|Balafilcon A contact lenses|Silicone hydrogel contact lenses worn for 30 days, Phase 1
16160542|NCT01699750|Device|ReNu® Multiplus®|Contact lens care system used for 30 days, Phase 1
16160543|NCT01699737|Drug|JTT-851|
16160544|NCT01699737|Drug|Glimepiride|Encapsulated Glimepiride tablets
16160545|NCT01699737|Drug|Placebo for Active|
16160546|NCT01699737|Drug|Placebo for comparator|
16160547|NCT01699724|Drug|JZoloft|50 mg tablet on Day 1 of each period
16160548|NCT01699724|Drug|sertraline ODT|50 mg tablet on Day 1 of each period
16160549|NCT01699724|Drug|sertraline ODT|50 mg tablet on Day 1 of each period
16231381|NCT01151813|Drug|Placebo|Placebo
16160550|NCT01699711|Dietary Supplement|Epigallocatechin-3-gallate (EGCG)|EGCG administration in Down syndrome patients will result in an improvement of their cognitive performance. A daily oral dose containing 9 mg/kg (range 6.9-12.7) of EGCG is given during twelve months.
16160551|NCT01699698|Other|Tumor markers|Duodenal juice are collected using endoscope and cannula. Tumor markers of collected samples are analyzed. The marker concentration is applied to statistical analysis.
16160552|NCT01699685|Drug|QAB149|Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI
16160553|NCT01699685|Drug|Placebo|Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI
16160554|NCT01699685|Drug|NVA237|Capsule form in blister packs inhaled with the Novartis Concept 1 SDDPI
16160555|NCT01699672|Other|Group information|The patients will receive two 1.5-2 hour standardized validated group information sessions in addition to regular information from their doctors and nurses.
16160556|NCT01699659|Other|allergen immunotherapy|allergy shots
16160557|NCT01699646|Device|Neoventa S 21 ST-ANalysis of fetal heart|"Application of gold-trace scalp electrode"
16160558|NCT01699646|Procedure|CTG + FBS|Cardiotocography and fetal blood sampling on/from fetal skalp
16160559|NCT01699620|Procedure|BAHA implant insertion|The intervention is insertion of the Cochlear Bi300 to be used for bone anchored hearing aid.
16160560|NCT01699607|Drug|Amphetamine|All subjects will receive amphetamine to induce elevated dopamine levels in the brain at 0.5mg/kg
16160561|NCT01699594|Drug|Mannitol|Indirect bronchoprovocation agent being compared to direct bronchoprovocation agent (methacholine)
16160562|NCT01699594|Drug|Methacholine Chloride|Direct bronchoprovocation agent being compared to indirect bronchoprovocation agent (mannitol)
16160563|NCT01699581|Dietary Supplement|Nestle Impact Advanced Recovery|dose of Nestle Impact Advanced Recovery orally three times a day beginning on the morning following stem cell transplant and continued until the day of hospital discharge.
16160564|NCT01699568|Device|RFA|Each week since the surgery the implant stability will be measure with the Osstell mentor to verify the resonance frequence analysis, using the smartpeg number 21
16160565|NCT01699555|Biological|GNbAC1|Single dose intravenous (IV) GNbAC1 of 0.0025mg/kg, 0.025mg/kg, 0.15mg/kg, 0.60mg/kg, 2.00mg/kg or 6.00mg/kg
16160566|NCT01699555|Biological|GNbAC1 placebo|Single dose intravenous (IV) GNbAC1 placebo
16160567|NCT01699542|Device|WallFlex Esophageal RX Fully Covered Stent|Temporary placement of the WallFlex Esophageal RX Fully Covered Stent for treatment of refractory anastomotic esophageal strictures. The stent will be removed after 8 weeks (plus or minus 7 days) indwell
16160568|NCT01699542|Device|Esophageal Bougie Dilator Per Investigator preference|Commercially available Esophageal Bougie Dilator Per Investigator preference
16160569|NCT01699529|Device|Medtronic Multi-electrode Radiofrequency (RF) Renal Denervation system|The Medtronic Multi-electrode Radiofrequency Renal Denervation System is comprised of a single-use, disposable catheter and a reusable generator.
16160570|NCT01699503|Behavioral|Collaborative Dementia Care Program|Much of the intervention, facilitated by care coordinator, is targeted to co-manage or support the practice behavior of primary care clinicians, enhance self-management skills of both the care-recipient and the informal caregiver, and maximize the coping behavior of the patient and the informal caregiver.
16160571|NCT01699490|Drug|Fluoxetine + Valsartan|The curative effect of fluoxetine add-on valsartan 40 mg per day for 12 weeks therapy in the treatment of major depressive disorder.
16160572|NCT01699490|Drug|Fluoxetine + Placebo|The curative effect of fluoxetine add-on placebo therapy in the treatment of major depressive disorder.
16160573|NCT01699477|Device|ExAblate 4000 focused ultrasound brain intervention|Non-invasive brain intervention using MR-guided focused ultrasound
16160574|NCT01699464|Drug|AR-12286 Ophthalmic Solution 0.7%|Ophthalmic Solution
16160575|NCT01699464|Drug|AR-12286 Ophthalmic Solution 0.5%|Ophthalmic Solution
16160576|NCT01699464|Drug|Timolol maleate ophthalmic solution 0.5%|Ophthalmic Solution
16160577|NCT01699438|Drug|Mesalazine|2400 mg q.d. for 8 weeks
16160578|NCT01699438|Drug|Placebo|3 tablets q.d. for 8 weeks
16160579|NCT01699425|Device|Ajust sling|
16160580|NCT01699425|Device|Classical transobturator sling|Control group
16160581|NCT01699412|Drug|Clobetasol|Rinse with a solution of clobetasol 0.05% associated to nystatin 100,000 UI/mL, for 1 minute, during 28 days
16160582|NCT01699412|Drug|Dexamethasone|Rinse with a solution of dexamethasone 0.1 mg/mL associated to nystatin 100,000 UI/mL, for 1 minute, during 28 days
16160583|NCT01699399|Procedure|water immersion|
16160584|NCT01699399|Procedure|water exchange|
16160585|NCT01699399|Procedure|air insufflation|
16160586|NCT01699386|Other|Control Study Formula|feed as lib
16160587|NCT01699386|Other|Experimental Study Formula|feed as lib
16160588|NCT01699373|Procedure|Ultrasound scan|Pre-procedural ultrasound scan was performed
16160589|NCT01699360|Drug|Cyclosporine A, Tacrolimus, Sirolimus|
16160590|NCT01699347|Drug|Intracystic injection of OK432 under US guiding|Intracystic injection of OK432 under US guiding
16160591|NCT01699334|Behavioral|Psychoeducational video|The educational video will explain the nature of whiplash injuries and provide a biopsychosocial model for neck pain incorporating both physiological and cognitive-behavioural aspects, reassurance and basic advice on pain relief.
16160592|NCT01699334|Other|Relaxation video|The comparison condition is a relaxation video detailing simple relaxation exercises such as breathing exercises which can be safely used by whiplash patients. The relaxation video contains no explanatory information concerning whiplash injuries or the related symptoms.
16160593|NCT01699321|Behavioral|Your Move (physical activity)|Materials that are provided will aim to increase a participant's minutes of physical activity.
16160594|NCT01699321|Other|Your Money (financial empowerment)|Materials that are provided to participants will direct them to resources for financial health.
16160595|NCT01699308|Drug|Genotropin|
16160596|NCT01699295|Behavioral|A+PAAC|academic lessons delivered by regular classroom teachers using moderate to vigorous physical activity (MVPA) for 20 minutes/day, 5 days/week.
16160597|NCT01699295|Behavioral|CON|lessons taught by regular classroom teachers using traditional/regular sedentary lessons
16160600|NCT01699269|Other|peritumoral glial cell infiltration|
16161671|NCT01690520|Drug|Fludarabine Phosphate|Given IV
16160601|NCT01699256|Behavioral|Guideline implementation as usual|Newsletters and Invitation to Meetings
16160602|NCT01699256|Behavioral|Enhanced guideline implementation strategy|Enhanced guideline implementation strategy
16160603|NCT01699230|Dietary Supplement|Omega 3|To show the existence of a atrial cardiomyocytes membranes modification in omega-3 supplemented patients with coronary atherosclerosis
16160604|NCT01699204|Dietary Supplement|N-acetylcysteine|N-acetylcysteine 600mg taken orally 3 times daily for 6 days prior to exposure to diesel exhaust for 2 hours. The last supplement was taken the morning of the exposure
16160605|NCT01699204|Other|Diesel exhaust|A placebo tablet taken 3 times daily for 6 days prior to exposure to diesel exhaust for 2 hours. The last supplement was taken the morning of the exposure
16160606|NCT01699204|Other|Filtered air|A placebo tablet taken 3 times daily for 6 days prior to exposure to filtered air for 2 hours. The last supplement was taken the morning of the exposure
16160607|NCT01699191|Dietary Supplement|Probiotic|
16160608|NCT01699191|Dietary Supplement|Placebo|
16160609|NCT01699178|Drug|Oral testosterone undecanoate|Total daily dose of T = 200 mg T (as 316 mg TU) to 600 mg T (as 948 mg TU), taken as 100 mg to 300 mg T BID
16160610|NCT01699178|Drug|Transdermal testosterone gel (AndroGel)|Total daily dose of T = 2.5 to 10 g of gel (25 mg to 100 mg T) QD
16160611|NCT01699165|Device|Nasal filter|Active nasal filter
16160612|NCT01699165|Device|Placebo nasal filter|Placebo nasal filter
16160613|NCT01699152|Drug|TG02 citrate|TG02 citrate capsules
16160614|NCT01699139|Device|positional device|Avoidance of supine positioning was achieved by use of the commercially available ZZoma Positional Device, which is the FDA cleared class II positional medical device. The device is 12 x 5.5 x 4 inches in size and made of lightweight semi-rigid synthetic foam. It is contained in the nylon material with an associated Velcro belt. Zzoma is a positioner worn around the upper torso to restrict patient movement from side to supine.
16160615|NCT01699139|Device|lumbar corset|A lumbar (abdominal) binder is made of an elastic fabric with Velcro closure. Subjects wore the prefabricated lumbar corset during sleep and were positioned ad lib.
16160616|NCT01699126|Device|CPAP|Continuous Positive Airway Pressure is the routine treatment of OSA, patients will be randomly assigned into CPAP treatment group
16160617|NCT01699126|Drug|Statin|Statin is an lipid lowering medication with anti-inflammatory effect.
16160618|NCT01699113|Drug|YF476|"Subjects will be randomised to once daily treatment by mouth for 6 weeks with:
~YF476 100 mg; or
~rabeprazole 20 mg; or
~a combination of YF476 100 mg and rabeprazole 20 mg."
16160619|NCT01699113|Drug|Rabeprazole|"Subjects will be randomised to once daily treatment by mouth for 6 weeks with:
~YF476 100 mg; or
~rabeprazole 20 mg; or
~a combination of YF476 100 mg and rabeprazole 20 mg."
16160620|NCT01699100|Other|device|Experimental: insole In-shoe plantar pressure measurements were performed in 26 patients with diabetic neuropathic feet at baseline condition, and 52 regions of interest (ROIs, with mean peak pressure > 200kPa or with the highest mean peak pressure in the forefoot area) were identified as suitable areas for removal of pegs. Data of in-shoe plantar pressures of the three insole conditions (pre-peg removal, post-peg removal, and post-peg removal plus arch support) were collected. Mean peak pressure (MPP) and pressure-time integral (PTI) were recorded for analysis.
16160621|NCT01699087|Procedure|Photorefractive keratectomy (PRK)|In this corneal surgical procedure, the outer corneal epithelial layer will be removed, after which the corneal stroma will be reshaped by excimer laser ablation to reduce or eliminate refractive errors.
16160622|NCT01699087|Device|ALLEGRETTO WAVE EYE-Q excimer laser system|The ALLEGRETTO WAVE EYE-Q excimer laser system is used for corneal stroma reshaping during PRK surgery
16160623|NCT01699074|Dietary Supplement|1 gram of White Korean Ginseng|1 gram of White Korean Ginseng
16160624|NCT01699074|Dietary Supplement|3 grams of White Korean Ginseng|3 grams of White Korean Ginseng
16160625|NCT01699074|Dietary Supplement|6 grams of White Korean Ginseng|6 grams of White Korean Ginseng
16160626|NCT01699074|Dietary Supplement|3 grams of Wheat Bran Control|3 grams of Wheat Bran Control
16160627|NCT01699074|Dietary Supplement|500mg of Korean Red Ginseng|500mg of Korean Red Ginseng
16160628|NCT01699061|Drug|Tivantinib|3 tivantinib tablets 120 mg administered twice daily with a meal starting on Day 2
16160629|NCT01699061|Drug|Placebo|Placebo tablet administered with a meal twice a day on Day 1
16160630|NCT01699048|Procedure|Hybrid (MIDCAB+PCI)|Hybrid approach (Minimally invasive of-pump revascularization of the left anterior descending artery (LAD) via left internal mammary artery (LIMA) bypass with consecutive percutaneous coronary intervention (PCI) in the rest arteries with drug eluting stents (DES). The revascularization will be performed in two stages within a 3-days interval
16160631|NCT01699048|Procedure|PCI|Multi-vessel PCI with DES
16160632|NCT01699048|Procedure|CABG|Coronary artery bypass graft (CABG) treatment
16160633|NCT01699022|Drug|Injection Cyclofem|"Injection Cyclofem contains 25 mg medroxyprogesterone acetate (MPA) and 5 mg estradiol cypionate as a microcrystalline suspension in 0.5ml aqueous solution and is supplied in vials.
~Women were administered three consecutive monthly injections of Cyclofem for prevention of ovulation, and were followed until the 92nd day from the last (third) injection."
16160634|NCT01699009|Other|Plant based diet|
16160635|NCT01699009|Other|an unrestricted diet|
16160636|NCT01698996|Procedure|Packing vs No Packing|
16160637|NCT01698970|Other|1-Freeze-dried Probiotics provided in capsule (150 mg) containing 1,0x10E10 colony forming unit per capsule (test)|1- 6 test products/day
16160638|NCT01698970|Other|2- excipients (150 mg) in capsule (control)|2- 6 control poducts/day
16160639|NCT01698957|Other|Any patient eligible for an Ultrasound greater than or equal to 18 weeks gestation without a fetal or uterine anomaly.|bilateral Uterine artery Doppler readings pre- and during blood pressure measurement
16160640|NCT01698944|Drug|somatropin|Initial dose 0.5 IU/day and escalated up to maximum dose the first 6 months. Maximum dose 3.0 IU/day for 18 months. Injected subcutaneously (s.c., under the skin) daily
16160641|NCT01698931|Drug|repaglinide|1 mg before each main meal on three separate dosing visits separated by a wash-out period
16160642|NCT01698931|Drug|glyburide|5 mg before breakfast and before supper on three separate dosing visits separated by a wash-out period
16160643|NCT01698931|Drug|placebo|Before each main meal on three separate dosing visits separated by a wash-out period
16160644|NCT01698918|Drug|Everolimus|Everolimus will be self-administered as a daily dose of 10mg (two 5mg tablets) taken orally continuously from study day 1 until progression of disease, unacceptable toxicity or withdrawal of consent. Everolimus should be taken at the same time every day. Everolimus tablets should be swallowed whole with a glass of water once daily, either consistently with food or consistently without food. Tablets should not be chewed or crushed.
16160645|NCT01698918|Drug|Letrozole|1st line study treatment: Letrozole will be self administered as a daily dose of 2.5mg continuously from study day 1 until disease progression, unacceptable toxicity or withdrawal of consent and should be taken at the same time every day, consistently with or without food. Everolimus and letrozole tablets should be taken together.
16160646|NCT01698918|Drug|Exemestane|2nd Line Study Treatment: If patients progress on everolimus + letrozole, patients will be offered everolimus + exemestane. Exemestane will be self administered as a daily dose of 25mg taken orally continuously until disease progression, unacceptable toxicity or withdrawal of consent and should be taken at the same time every day after a meal. Everolimus and exemestane tablets should be taken together.
16160647|NCT01698918|Drug|Alcohol-free dexamethasone mouth rinse|At the onset of symptoms suggestive of stomatitis patients must contact the study site. Upon confirmation of stomatitis at the site, patients in countries where the alcohol-free 0.5mg/5ml dexamethasone oral solution is commercially available will be randomly assigned to take either dexamethasone 0.5 mg/5ml mouth rinse or the standard of care used to treat stomatitis at the patient's center. The mouth rinse will be self administered at a daily dose of 10ml 3 times per day. Patients will be instructed to swish and expectorate the mouth rinse. Patients will also be instructed to fill out the Oral Stomatitis Daily Questionnaire (OSDQ) at home every day until the patient recovers. The mouth rinse will be self administered at a daily dose of 10ml 3 times per day.Patients will be instructed to swish and expectorate the mouth rinse.
16160648|NCT01698905|Drug|nilotinib|"Nilotinib was dosed by weight or body surface area.
~Nilotinib 300 mg BID or 400 mg BID was be administered orally at approximately 12 hour intervals, and must not have been taken with food. The capsules were to be swallowed whole with water.
~No food should have been consumed for at least 2 hours before the dose was taken and no additional food should have been consumed for at least one hour after the dose was taken. Patients were also allowed to enter this study on the same dose they were taking prior to study entry. Patients who required permanent dose reduction from their original starting dose were to be allowed to enter this study on the same dose only if the patient maintained this dose for a minimum of 6 months prior to study entry."
16160649|NCT01698892|Drug|I.V Sedation|Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the I.V. sedation group
16160650|NCT01698892|Drug|sublingual sedation|Patients who will undergo bronchoscopy will be followed during one day. They will be randomized in the sublingual sedation group
16160651|NCT01698879|Drug|Mylotarg|"Cohort 1 version 1.0. GO: 6mg/m^2 (maximum 10 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine: 100 mg/m^2 IV days 1 to 7, to begin 4 hours after the administration of GO.
~Cohort 1.0 version 2.0: GO: 3 mg/m^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine: 100 mg/m^2 IV days 1 to 7, to begin 4 hours after the administration of GO.
~Cohort 2: G-CSF: 150 mcg/m^2, SC, days 0 to 7. GO: 3 mg/m^2 (maximum 5 mg), IV infusion, 2 hours, day 1. Idarubicin: 12 mg/m^2, IV, 30 minutes, on days 2, 3, 4. Cytarabine: 100 mg/m^2 IV continuous infusion on days 1 to 7, to begin 4 hours later after the administration of GO."
16160652|NCT01698866|Biological|Vaccin GenHevac B Pasteur|
16160653|NCT01698840|Dietary Supplement|Vitamin D|
16160654|NCT01698840|Dietary Supplement|Placebo|
16160655|NCT01698827|Other|Tube assessment visits|Patients will return every 2 months for clinical questionnaire about leaks, obstructions or other dysfunctions of the tube. Objective tube examination for cracks, rupture, obstruction or dislodgement, along with replacement if necessary, will be carried out (total of 3 visits/6 months)
16160656|NCT01698814|Drug|AL-4943A Ophthalmic Solution|
16160657|NCT01698814|Drug|AL-4943A Ophthalmic Solution Vehicle|Inactive ingredients used as placebo
16160658|NCT01698801|Drug|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 of each 28-day cycle
16160659|NCT01698801|Drug|dexamethasone|40 mg oral dexamethasone once daily on Days 1, 8, 15 and 22 of each 28-day cycle
16160660|NCT01698788|Drug|Dexamethasone Drug delivery system (Ozurdex)|It is a sustained release intravitreal implant containing 700µg dexamethasone
16160661|NCT01698775|Drug|Omarigliptin|Participants with moderate renal insufficiency will receive one omarigliptin 25 mg capsule orally once a week; participants with severe renal insufficiency or end stage renal disease will receive one omarigliptin 12.5 mg capsule orally once a week
16160662|NCT01698775|Drug|Placebo to omarigliptin|Matching placebo to omarigliptin capsule administered orally once a week
16160663|NCT01698775|Drug|Glipizide|Phase A: Participants may receive open-label glipizide as rescue therapy up to Week 24 of the study. Phase B: Participants who received placebo to omarigliptin during Phase A and are not on background insulin therapy or who did not receive open-label glipizide or insulin as rescue therapy during Phase A of the study Week 1 through Week 24) will receive glipizide capsule(s) 2.5 daily up to a maximum of 20 mg daily (based on glycemic control) in a blinded manner during Phase B of the study (Week 24 through Week 54).
16160664|NCT01698775|Drug|Placebo to glipizide|Matching placebo to glipizide daily
16160665|NCT01698775|Biological|Insulin|Participants on insulin therapy at screening will continue insulin therapy during the study. Insulin glargine therapy may be administered as rescue therapy as determined by the investigator.
16160666|NCT01698762|Other|Multimedia Patient Decision Aids (MM-PtDAs)|Patient group will watch a DVD of information about their disease type.
16160667|NCT01698762|Other|Comparative Effectiveness Research Summary Guide (CERSG)|Patient group to read a booklet about their disease type.
16160668|NCT01698762|Behavioral|Questionnaires|Questionnaires completed at baseline, 3, and at 6 months.
16160669|NCT01698749|Drug|long acting intravitreal dexamethasone implant|Intravitreal ozurdex was given in diabetic patients with clinically significant macular edema and they were followed up for change in central macular thickness and visual acuity over a period of 6 months
16160670|NCT01698736|Device|Membrane filtration|Membrane filtration (Polysulfone)
16160671|NCT01698736|Device|Semiselective IA|Semiselective immunoadsorption (GAM peptide adsorber)
16160672|NCT01698723|Drug|Ribavirin|
16160673|NCT01698723|Drug|Placebo|
16160674|NCT01698710|Drug|Albumin bound paclitaxel|Albumin bound paclitaxel will be administered into the mucinous cyst of pancreas in endoscopy procedure.
16160675|NCT01698697|Drug|insulin aspart|Bolus 0.1 U/kg administered simultaneously with a continuous infusion of 0.029 U/kg/h via a programmed insulin pump. A total dose of 0.35 U/kg is delivered to the subject in the 12 hour infusion
16160676|NCT01698684|Drug|Placebo|One dose 15 minutes before attempting intercourse
16160677|NCT01698684|Drug|Avanafil 100 mg|One dose 15 minutes before attempting intercourse
16160678|NCT01698684|Drug|Avanafil 200 mg|One dose 15 minutes before attempting intercourse
16160679|NCT01698671|Device|InterGard Synergy Vascular Graft|
16160680|NCT01698658|Other|ultrasound tomography|Undergo ultrasound tomography using SoftVue
16160681|NCT01698658|Procedure|magnetic resonance imaging|Undergo MRI of the breast
16160682|NCT01698645|Drug|PecFent® (fentanyl) nasal spray|
16160683|NCT01698606|Behavioral|Multidisciplinary, family-centered lifestyle intervention with behavioral counseling|Parent/caregiver education with skill training and practical activities revolving around healthy dietary choices, establishing an active versus a sedentary lifestyle, and behavioral aspects, while children will be engaged in active play.
16160684|NCT01698593|Drug|Bupivacaine 0.5%|
16160685|NCT01698593|Drug|Bupivacaine 0.5% + Epinephrine (1:200,000)|
16160686|NCT01698580|Other|On-site exercise|The program will consist of progressive balance, including postural orientation and anticipatory postural adjustments sensory-motor activities, and strengthening exercises to enhance balance and postural control and reduce falls. Exercises in the standing position will be prioritised in order to target balance control.Exercises will be both static and dynamic, and will get progressively more challenging, in order to reach the individual optimal level of balance and strength functional status.
16160687|NCT01698580|Other|home-based exercise|Participants will be provided with a detailed booklet containing safety precautions, instructions and photographs of exercises for use in exercise sessions at home and will be instructed to do the exercises preferably under the supervision of a relative or caregiver, in a suitable place (with good lighting and ventilation) and using proper support (close to a table or chair, or the corner of a wall). In the first four weeks of intervention the patients will stay for 30 minutes after the therapy sessions in order to learn the home exercises. The exercises will be reviewed, if necessary, after each session till the last week of intervention. All necessary equipment to undertake the exercise program will be provided.
16160688|NCT01698580|Other|Educational and behavioural|Sessions will address specific environmental and behavioural risk factors delivered by trained health professionals,lasting for 30 minutes and will use appropriate language for lay people.Each meeting will be consisted of a brief introduction on the core day topic with supporting audio-visual or graphic material, followed by group discussion in order to identify the beliefs and attitudes of participants regarding falls and any major restriction or barrier for the implementation of preventive strategies. Participants will be encourage to report their own experiences and beliefs. The activity will always end with the reinforcement of the core message of the session.
16160689|NCT01698580|Other|Management of modifiable risk factors|Postural hypotension: review of medications that may contribute to postural hypotension;Visual impairment: Participants identified as having visual problems will be referred to an ophthalmologist. The use of four or more medications or the use of psychotropic medication: A review of the risk-benefit of using specific medications will be undertaken, especially psychotropic and anti-hypertensive drugs; Foot problems and shoes: Guidance on the use of proper footwear, nail care and the treatment of cutaneous mycoses will be given; Undernutrition: Participants with a BMI lower than 22 kg / m2 and or a leg calf under 31cm will be oriented to increase their protein and calorie intake and will be referred to a nutritionist.
16160690|NCT01698580|Other|Usual care|The control group will receive a baseline assessment to identify risk factors for falls and will be referred to their clinicians with a report of individual modifiable risk factors to be managed without any specific guidance: referral to routine services, treatments or any specific orientation will be at the discretion of their primary clinicians. So, further management of each participant in the control group will be individualized, with no specific protocol. Interventions will be recorded. Participants will receive a leaflet with basic orientations for fall prevention.
16160691|NCT01698567|Drug|Antithrombin III|"ATIII will be dosed using the formula recommended by the manufacturer:
~(goal activity - baseline activity) x weight (kg) x .714 (Assume: start with 35% activity [7], goal 120% activity[18], so dose = 120-35 x wt (kg) x .714, e.g. 5 kg infant: 85 x 5 x .714 = 303 units)"
16160692|NCT01698567|Drug|Placebo|placebo (normal saline) after induction of anesthesia and before commencement of bypass. ATIII will be dosed using the formula recommended by the manufacturer: (goal activity - baseline activity) x weight (kg) x .714 (Assume: start with 35% activity [7], goal 120% activity[18], so dose = 120-35 x wt (kg) x .714, e.g. 5 kg infant: 85 x 5 x .714 = 303 units)
16160693|NCT01698554|Drug|bimatoprost formulation A solution|Bimatoprost formulation A solution applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
16160694|NCT01698554|Drug|bimatoprost solution 0.03 %|Bimatoprost solution 0.03 % (LATISSE®) applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
16160695|NCT01698554|Drug|vehicle of bimatoprost formulation A solution|Vehicle of bimatoprost formulation A solution applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
16160696|NCT01698554|Drug|vehicle of bimatoprost solution 0.03 %|Vehicle of bimatoprost solution 0.03 % applied to the upper eyelid of both eyes once daily for 4 months using the supplied applicator.
16160697|NCT01698541|Drug|Tacrolimus|Tested generic
16160698|NCT01698541|Drug|Tacrolimus|Original formulation used as comparator
16160699|NCT01698528|Device|Tablet Computer|
16160700|NCT01698476|Drug|vitamin D (cholecalciferol) and PBA (sodium phenylbutyrate)|Dose of interventions: 5,000 IU of vitamin D (cholecalciferol tablets) once daily and 500 mg PBA (sodium phenylbutyrate tablets) twice daily for 16 weeks.
16160701|NCT01698476|Drug|Placebo tablets|
16160730|NCT01698203|Drug|ropivacaine 0.2% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun)|The patient will then ongoing administration of ropivacaine 0.2% during the first 48 postoperative hours, using a diffuser extensible elastomeric ™ Easypump a volume of 400 mL to 460 mL filled (B Braun) of this solution, a flow rate of 9.53 ml / hour
16160803|NCT01697579|Drug|5-hydroxytryptamine 3 antagonist|Administered IV according to local labeling and/or local standard of care
16160702|NCT01698463|Other|Identification of patients at risk, tailored exercise prescription, motivational interviewing, review of behavioural outcomes|"The intervention was delivered in two visits and two follow-up phone calls.
~Physician identifies that the patient is at risk of falls or fractures
~Visit one: individualized exercise prescription by a physiotherapist.
~Visit two: motivational interviewing (behavioural counselling) by kinesiologist
~Phone call 1 and 2: Kinesiologist reviews behavioural components (action planning, coping planning, coping self-efficacy, intentions."
16160703|NCT01698450|Device|Non-invasive intervention with focused ultrasound (ExAblate 4000)|Non-invasive brain intervention using MR-guided focused ultrasound
16160704|NCT01698437|Device|Non-invasive intervention with focused ultrasound (ExAblate 4000)|Non-invasive brain intervention using MR-guided focused ultrasound
16160705|NCT01698398|Device|Incremental pump speed of CF-LVAD.|Peak oxygen consumption with fixed versus incremental pump speed.
16160706|NCT01698385|Other|Diet and exercise counseling|diet and exercise counseling, setting of specific goals, follow-up of achievements, laboratory tests and measurements
16160707|NCT01698372|Device|Prevena device (Group A)|This portable device is applied to initiate negative pressure therapy to a wound site.
16160708|NCT01698346|Biological|Pertussis vaccine|Vaccination during pregnancy with a pertussis containing vaccine
16160709|NCT01698333|Drug|122-0551|Applied twice daily for 2 weeks
16160710|NCT01698320|Drug|Placebo MDPI|Placebo MDPI (multi-dose dry powder inhaler) to match the active intervention.
16160711|NCT01698320|Drug|Albuterol MDPI|Albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation.
16160712|NCT01698307|Other|Enhanced Treatment Algorithm|The Enhanced algorithm features the early use of combined antimetabolite/adalimumab therapy, and treatment intensification based on ileocolonoscopic findings. Failure to achieve or sustain Deep Remission, which includes sustained normalization of the imaging studies, will result in treatment intensification, according to the steps outlined in the algorithm, irrespective of symptoms.
16160713|NCT01698307|Other|Conventional Step-care Algorithm|Step-care algorithm that specifies treatment escalation solely on the basis of symptoms quantified using the Harvey Bradshaw Score.
16160714|NCT01698294|Other|Clinical Observation|Participants maintain usual diet and undergo clinical observation
16160715|NCT01698294|Dietary Supplement|Flaxseed|Given PO
16160716|NCT01698294|Other|Laboratory Biomarker Analysis|Correlative studies
16160717|NCT01698294|Other|Questionnaire Administration|Ancillary studies
16160718|NCT01698281|Drug|AEZS-108|"AEZS-108 (267 mg/m2, 2-hour IV infusion every Day 1 of a 21-day (3-week) cycle. Allowed delay of re-treatment: up to 2 weeks.
~Dose reduction: to 210 mg/m2 and 160 mg/m2, if dose limiting toxicity."
16160719|NCT01698281|Drug|SCCC|"commercially available SSCC (doses below the recommended package insert at the discretion of treating oncologist), on a 21-day cycle (although weekly administration is allowed; note: pegylated liposomal doxorubicin will be administered on a 28-day cycle).
~Drugs considered acceptable as SSCC: paclitaxel; nab-paclitaxel; eribulin; pegylated liposomal doxorubicin (PLD); vinorelbine; gemcitabine; capecitabine.
~Related to PLD: Per notification from EMA (dated 22-Nov-2011) no new patients should be started on treatment with Caelyx until further notice. Accordingly, this drug may be selected as SSCC treatment option only after such written notice is available."
16160720|NCT01698281|Drug|Dexamethasone|Recommended prophylactic anti-emetic for AEZS-108: 8 mg dexamethasone.
16160721|NCT01698268|Procedure|TAP block|TAP Block will be performed under ultrasound guidance via Sonosite device with an in-plane technique by the anesthesiologist.
16160722|NCT01698268|Procedure|Local Infiltration|Local infiltration of 0.5 cc/kg of 0.25% ropivacaine will be administered by the surgeon.
16160723|NCT01698255|Behavioral|ENGAGE|
16160724|NCT01698255|Behavioral|Standard of Care Psychotherapy|
16160725|NCT01698242|Behavioral|Enhanced Training|"PCP-Level: A PCP randomized to the Enhanced Training (ET) group will receive: 1) a full and pocket sized copy of the current AHA Heart Failure (HF) Guidelines; 2) a summary of their patient's data collected at baseline, 6-month, and 30-month in-person study visits; and 3) an invitation to complete the CHART-designed online course in HF management for CME credit.
~Patient Level: The ET patient-level intervention uses Community Health Workers (CHWs) to assist the patient in learning self-management behaviors to reduce the risk of hospitalization. The key objectives are to: improve heart failure knowledge; encourage use of HF management tools; and facilitate development of self-management skills. Each participant receives at least: six AHA educational mailings, six monthly home visits, and 18 phone calls by CHWs within the first six months of the intervention. The CHW then conducts monthly telephone visits for the subsequent two years (for a total of 30 months of follow-up)."
16160726|NCT01698242|Behavioral|Enhanced Education|"The Enhanced Education (EE) intervention follows a multi-level strategy in which both the patient and their PCP are intervened upon concurrently. The intervention provides nominal information through the mail. Randomization occurs at the PCP-level; patients are assigned to the EE group only if their PCP already has been randomized to this group.
~PCP Level: Upon randomization to the EE group each PCP will receive a full-sized copy of the current American Heart Association (AHA) Heart Failure Guidelines within thirty days after randomization.
~Patient Level: Upon their assignment to the EE group, patients will receive: Six AHA Tip-Sheet mailings (one Tip-Sheet to be mailed each of the first six months following group assignment); a telephone call, made by the CHART Research Assistant (RA), completed once during each of the first six months following group assignment and only to confirm that the patient received the Tip-Sheet mailing for that month."
16160727|NCT01698229|Other|Group 1|Collecting a small amount of cerebrospinal fluid (5 mL) from healthy children, ages 2 yrs - 8 yrs, who are already undergoing a lumbar puncture procedure at New York Presbyterian Hospital for clinical or diagnostic purposes.
16160728|NCT01698203|Drug|ropivacaine 0.75% - device : wound catheter Silver™ 19 cm and Easypump™ 400 mL (BBraun)|The group ropivacaine, an initial bolus of 0.75% ropivacaine at a volume of 0.1 ml / kg is first administered to the patient directly on the catheter.
16160729|NCT01698203|Drug|Placebo|In the placebo group, an initial bolus of saline 9 ‰ to a volume of 0.1 ml / kg will first be administered to the patient directly to the catheter. The patient will then continuous administration of saline 9 ‰ during the first 48 postoperative hours, using a diffuser extensible elastomeric ™ Easypump a volume of 400 mL to 460 mL filled of this solution, a flow rate of 9.53 ml / hour.
16160801|NCT01697579|Drug|Fosaprepitant Placebo|Administered IV as a single dose
16234407|NCT01128322|Drug|Telmisartan|
16160731|NCT01698190|Procedure|Endoscopic ultrasound guided needle tissue acquisition.|Endoscopic ultrasound with fine needle aspiration (FNA) allows for the safe and efficacious sampling of solid lesions that are in close proximity to the gastrointestinal tract, including extraintestinal masses, subepithelial tumors, and peri-intestinal lymphadenopathy. Fine needle core biopsy (FNB) has the potential of accruing larger tissue samples during biopsies, which may make the procedure more efficacious. In our study, we are comparing the overall efficacy between these two needles which are currently both used as standard of care.
16160732|NCT01698177|Biological|Influenza vaccine|Seasonal inactivated trivalent vaccine
16160733|NCT01698177|Biological|Influenza vaccine|Seasonal inactivated trivalent vaccine
16160734|NCT01698164|Drug|estradiol plus MPA|Participants are given estradiol and synthetic progestin.
16160735|NCT01698164|Drug|Ximingting Tablet|Participants are given phytoestrogen.
16160736|NCT01698164|Drug|estradiol plus progesterone|Participants are given estradiol and natural progesterone.
16160737|NCT01698138|Drug|Onabotulinumtoxin A|"30 transurethral injections, each of 1 ml solution containing 300 U Onabotulinumtoxin A (Botox ®, Allergan) in 30 ml of NaCl 0.9 %."
16160738|NCT01698138|Drug|Placebo|30 transurethral injections, each of 1 ml solution containing NaCl.
16160739|NCT01698125|Procedure|Abdominal surgery|Patients 65 years or older scheduled for abdominal surgery at Oslo University Hospital
16160740|NCT01698112|Dietary Supplement|Flaxseed High Dose|26 gram flaxseed intervention
16160741|NCT01698112|Dietary Supplement|Flaxseed Low Dose|13 grams flaxseed
16160742|NCT01698086|Other|Vestibular rehabilitation: balance and eye movement exercises|The Experimental group will perform 1-hour supervised intervention sessions 2x/wk for 6-wks, then 1x/wk for 8-weeks, for a total of 20 supervised sessions. The intervention is a progressive vestibular rehabilitation program comprised of balance and eye movement exercises as detailed in our preliminary study report. The balance training includes standing and walking tasks on varied types of compliant surfaces, base of support, head movements, visual input and eye-hand tasks. The tasks will progress from simple to more complex. Eye movement exercises will include voluntary saccadic eye movements and smooth pursuit movements. Vestibulo-ocular eye training will be performed while visually fixating on a stationary object, while moving the head up and down and side to side at various speeds, progressing from sitting to standing on firm and compliant surface. Participants in the Experimental group will be given items of the exercise program to perform as a home exercise program.
16160743|NCT01698073|Behavioral|mCOL|
16160744|NCT01698073|Other|AS+|
16160745|NCT01698060|Biological|ND1.1|
16160746|NCT01698047|Behavioral|Resiliency Class|See Arm Description
16160747|NCT01698047|Other|Case Management|See Case Management description
16160748|NCT01698034|Behavioral|Volunteering|Weekly volunteering with elementary school children in after school programs
16160749|NCT01698008|Other|Diabetes Doctor Mobile app|Diabetes Doctor is a mobile application software. The mobile phone application allows a subject to register blood glucose values obtained from their fingerstick glucose meter readings, the type and amount of insulin they are administering, any notes they would like to document, and the date and time of each entry. All data will be entered by the subject manually. The data will be submitted through encryption coded private servers and can be retrievable by a physician on a password protected website for privacy. A physician will evaluate this information to recommend a change of the subject's insulin regimen. The recommended insulin regimen will be delivered to the patient using the same website and received by the subject on the same mobile application software.
16160750|NCT01697982|Behavioral|Living with Hope Program|"The Living with Hope Program involves viewing a short film entitled Living with Hope, which is based on the research team's grounded theory study, and shows cases of terminally ill persons and their family members talking about how they maintain their hope. Participants then choose to begin one of three hope activities: a) Write or ask someone to help you write one or more letters to someone begin to write a letter to someone, b) Begin a Hope Collection or c) begin an About Me Collection."
16160751|NCT01697982|Behavioral|LWH film|Participants will view the Living with Hope film which is based on the research team's grounded theory study, and shows cases of terminally ill persons and their family members talking about how they maintain their hope.
16160752|NCT01697969|Drug|Olopatadine hydrochloride ophthalmic solution, 0.2%|
16160753|NCT01697956|Drug|BDP|Beclomethasone dipropionate (BDP) 80 mcg/day (40 mcg/spray, 1 spray/nostril, once daily - total 2 sprays/day) as a nasal aerosol.
16160754|NCT01697956|Drug|Placebo|Placebo (1 spray/nostril, once daily - total 2 sprays/day) as a nasal aerosol.
16160755|NCT01697943|Procedure|Roux-En-Y Pouch Reconstruction or Conventional Roux-En-Y Reconstruction|
16160756|NCT01697930|Drug|[18F] 4-L-Fluoroglutamine (2S,4R)|Thirty cancer patients will receive an injection of a 0.5 to 7.5mCi of [18F] 4-LFluoroglutamine (2S,4R) , followed by serial PET/CT scanning and blood draws, (at the direction of the investigator) over a period of 3.5 hours, on a single day. Each patient will be offered the opportunity to repeat the [18F] 4-L-Fluoroglutamine (2S,4R) injection and subsequent set of post-injection PET-CT scans, once, on a separate date. At the discretion of the investigator, scan 3 can be waived. Immediately prior to injection of the radiotracer, a blood sample will be obtained for measurement of serum glutamine level. The serum glutamine level will be assayed, if necessary, as part of an amino acid screen assay.
16160757|NCT01697917|Other|Total Gastrectomy or Proximal Gastrectomy|
16160758|NCT01697904|Procedure|Titration of oxygen during newborn resuscitation in delivery room|
16160759|NCT01697891|Device|Codetron ALTENS|ALTENS stimulation of a set of selected acupuncture points for 20 minutes in each treatment. Two treatments per week for a total of 12 treatments to be delivered within 8 weeks.
16160760|NCT01697878|Procedure|CPAP followed by atmospheric pressure|In the PACU, Patients receive 2 hours of continuous-positive-airway-pressure (CPAP) oxygen at 30% FiO2 treatment followed by 2 hours of oxygen treatment (6 L O2/min) that is part of standard of care at Massachusetts General Hospital
16160761|NCT01697878|Procedure|Atmospheric pressure followed by CPAP|In the PACU, patients receive 2 hours of Oxygen treatment (6L/min) that is part of standard-of-care at Massachusetts General Hospital, followed by 2 hours of Continuous Positive Airway Pressure (CPAP) treatment at 30% FiO2.
16160762|NCT01697865|Procedure|Transfer group|
16160763|NCT01697865|Procedure|Control group|
16160802|NCT01697579|Drug|Ondansetron|Administered IV according to local labeling and/or local standard of care
16160764|NCT01697852|Other|Indoor residual spraying with bendiocarb|2 rounds of indoor residual spraying with bendiocarb insecticide, 4 months apart
16160765|NCT01697852|Other|LLIN by universal coverage campaign|Long lasting Insecticide treated mosquito net
16160766|NCT01697826|Drug|ClinSupV3 -soft gelatin capsule|3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg clotrimazole
16160767|NCT01697826|Drug|ClinSupV3ER- Extended release tablet|3 day treatment with intravaginal formulation containing 100mg Clindamycin and 200mg Clotrimazole
16160768|NCT01697800|Drug|Tadalafil|
16160769|NCT01697800|Drug|Placebo|
16160770|NCT01697787|Drug|Amodiaquine-Artesunate|If necessary, the study drug will be crushed, dissolved in water and squirted into the mouth using a spoonful. Administration of the treatments will be directly observed. After drug administration, patients will be kept for at least 30 minutes in the clinic. A dose will be repeated in full if vomiting occurs within 30 minutes of administration and halved if vomiting is between 30 minutes and 1 hour post dosing.
16160771|NCT01697787|Drug|Artemether-lumefantrine|If necessary, the study drug will be crushed, dissolved in water and squirted into the mouth using a spoonful. Administration of the treatments will be directly observed. After drug administration, patients will be kept for at least 30 minutes in the clinic. A dose will be repeated in full if vomiting occurs within 30 minutes of administration and halved if vomiting is between 30 minutes and 1 hour post dosing.
16160772|NCT01697761|Other|Treatment Group|patients receive herbs-partitioned moxibustion for 2 cones and acupuncture for 30 minutes，3 times a week for 12 weeks
16160773|NCT01697761|Other|Control Group|patients receive shallow needing and bran-partitioned moxibustion with the stimulation same to the treatment group.
16160774|NCT01697748|Device|Silver-impregnated dressing|Silver-impregnated dressing placed over Cesarean wound after skin closure; the dressing will be changed to saline-treated dressing on post-operative day 2 which will remain on the incision through post-operative day 7.
16160775|NCT01697748|Device|Telfa pad dressing|Telfa pad dressing placed over Cesarean wound after skin closure; the dressing will be changed to a new Telfa pad dressing on post-operative day 2 which will remain on the incision through post-operative day 7.
16160776|NCT01697735|Drug|Berberine;Atorvastatin or Rosuvastatin|Participants will receive 500mg Berberine twice a day for 8 weeks; Follow the previous administration program，participants will continue to receive 20mg Atorvastatin daily or 10mg Rosuvastatin daily.
16160777|NCT01697735|Drug|Atorvastatin or Rosuvastatin|Due to the different clinical prescriptions by different doctors and similar Efficacy in lowering lipids.Usually,Participants receive 20mg Atorvastatin daily or 10mg Rosuvastatin to treat hyperlipidemia.
16160778|NCT01697722|Drug|Extra-fine hydrofluoroalkane-beclometasone dipropionate|Increase in the baseline BDP-equivalent dose of inhaled corticosteroid as HFA-BDP via pMDI or BAI
16160779|NCT01697722|Drug|ICS / LABA via separate pMDI and / or BAI inhalers|A step-up from baseline ICS therapy via the addition of a separate long-acting beta-agonist with no change in baseline ICS drug or dose
16160780|NCT01697709|Drug|Quetiapine|Quetiapine pharmacotherapy for cannabis dependence
16160781|NCT01697709|Drug|Placebo|placebo capsules
16160782|NCT01697696|Drug|NVA237|NVA237 will be supplied in capsule form in blister packs for use in the Novartis Concept 1 SDDPI
16160783|NCT01697696|Drug|Long-acting beta 2-agonist (LABA)|QAB149 and matching placebo will be supplied in capsule form in blister packs for use in the Novartis Concept 1 SDDPI
16160784|NCT01697696|Drug|Placebo|Placebo to match QAB149
16160785|NCT01697683|Drug|Probiotic Lactobacilli|Two capsules per day containing either probiotic lactobacilli or placebo for 12 weeks
16160786|NCT01697683|Drug|Placebo|
16160787|NCT01697670|Drug|Photodynamic therapy with Gliolan|Laser light illumination with red light at 635 nm using a cylindrical light diffuser (Model RD, Medlight SA) in a white diffusing inflatable balloon catheter (model CDB OEB, Medlight SA) at a fluence rate of 65.5 mW/cm2 over 153 s resulting in a total light dose of 10 J/cm2 is performed 3 hours after administration of 15mg/kg bodyweight Gliolan
16160788|NCT01697657|Drug|insulin detemir|Subjects were dosed according to individual requirements. Injected subcutaneously (s.c. under the skin) twice daily in the morning and at bedtime for 10 weeks after an initial 6-week titration in treatment period 1 followed by 10 weeks after an initial 6-week titration in treatment period 2
16160789|NCT01697657|Drug|insulin NPH|Subjects were dosed according to individual requirements. Injected subcutaneously (s.c. under the skin) twice daily in the morning and at bedtime for 10 weeks after an initial 6-week titration in treatment period 1 followed by 10 weeks after an initial 6-week titration in treatment period 2
16160790|NCT01697657|Drug|insulin aspart|Subjects were dosed according to individual requirements. Injected subcutaneously (s.c. under the skin) twice daily before meals for 10 weeks after an initial 6-week titration in treatment period 1 followed by 10 weeks after an initial 6-week titration in treatment period 2
16160791|NCT01697644|Drug|somatropin|3 IU/m^2/day. Dose adjusted approximately every 3 months. Injected subcutaneously once daily
16160792|NCT01697644|Drug|somatropin|3 IU/m^2/day. Dose adjusted approximately every 3 months. Injected subcutaneously once daily
16160793|NCT01697631|Drug|biphasic insulin aspart 30|Administrated subcutaneously (s.c., under the skin) at breakfast and evening main meals
16160794|NCT01697631|Drug|insulin aspart|Administrated subcutaneously (s.c., under the skin) before lunch
16160795|NCT01697618|Drug|biphasic insulin aspart 30|Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs
16160796|NCT01697618|Drug|biphasic human insulin 30|Injected subcutaneously (s.c., under the skin) before breakfast and dinner, dosage adjusted throughout the trial according to individual needs
16160797|NCT01697605|Drug|BGJ398|
16160798|NCT01697592|Drug|Omarigliptin|Omarigliptin (MK-3102) 25 mg capsule administered orally once weekly. Pre-study basal medications include: SUs (gliclazide, glibenclamide, or glimepiride); Glinides (nateglinide , mitiglinide, or repaglinide); BGs (metformin); TZDs (pioglitazone); and α-GIs (acarbose, voglibose, or miglitol).
16160799|NCT01697592|Drug|Matching placebo to omarigliptin|Matching placebo to omarigliptin 25 mg capsule administered orally once weekly. Pre-study basal medications include: SUs (gliclazide, glibenclamide, or glimepiride); Glinides (nateglinide , mitiglinide, or repaglinide); BGs (metformin); TZDs (pioglitazone); and α-GIs (acarbose, voglibose, or miglitol).
16160800|NCT01697579|Drug|Fosaprepitant|Administered intravenously (IV) as a single dose
16160804|NCT01697566|Drug|Metformin|"Participants gradually increase the dose of metformin by mouth as listed below:
~Week 1: One capsule each day Week 2: One capsule 2 times each day Week 3: One capsule 3 times each day Week 4: Two capsules 2 times each day
~After week 4, participant continues to take 2 capsules of metformin 2 times each day.
~Each capsule is 425 mg."
16160805|NCT01697566|Other|Placebo|Placebo taken by mouth twice daily for 4, 30 day cycles.
16160806|NCT01697566|Procedure|Endometrial Biopsy|Endometrial biopsies obtained at baseline and after 4 months.
16160807|NCT01697566|Behavioral|Lifestyle Intervention|Lifestyle intervention consists of 16 in-person sessions offered over a 4 month period.
16160808|NCT01697566|Behavioral|Questionnaires|Completion of questionnaires about diet and exercise at baseline, during treatment and at end of study. Questionnaires take about 30-40 minutes to complete.
16160809|NCT01697553|Other|home automation pack coupled to teleassistance service|
16160810|NCT01697553|Other|Home without automation pack coupled to teleassistance service|
16160811|NCT01697527|Biological|aldesleukin|Given SC
16160812|NCT01697527|Drug|fludarabine phosphate|Given IV
16160813|NCT01697527|Drug|cyclophosphamide|Given IV
16160814|NCT01697527|Other|laboratory biomarker analysis|Correlative studies
16160815|NCT01697527|Biological|NY-ESO-1 reactive TCR retroviral vector transduced autologous PBL|Undergo NY-ESO-1 reactive TCR retroviral vector transduced autologous PBL
16160816|NCT01697527|Biological|dendritic cell vaccine therapy|Given NY-ESO-1-157-165 peptide pulsed dendritic cell vaccine ID
16160817|NCT01697527|Radiation|fludeoxyglucose F 18|Undergo PET scan using [18F] FDG tracer
16160818|NCT01697527|Procedure|positron emission tomography|Undergo fludeoxyglucose F18 PET
16160819|NCT01697514|Drug|LY2940680|Capsule administered orally.
16160820|NCT01697514|Drug|LY2940680|Powder administered orally (may be sprinkled on soft food).
16160821|NCT01697501|Other|Interleukin 28B testing|Blood sampling for IL28B genotyping
16160822|NCT01697475|Behavioral|Motivational text messaging|Motivational text messaging was given for participants in the intervention group - 3 times a day, 3 times a week, for 6 weeks
16160823|NCT01697436|Drug|ribavirin [Copegus]|tablet under fed condition
16160824|NCT01697436|Drug|ribavirin [Copegus]|tablet under fasted condition
16160825|NCT01697436|Drug|ribavirin [Copegus]|oral solution under fed condition
16160826|NCT01697436|Drug|ribavirin [Copegus]|oral solution under fasted condition
16160827|NCT01697423|Drug|platelet-rich plasma|
16160828|NCT01697423|Drug|durolane|
16160829|NCT01697410|Drug|Terlipressin|continuous infusion of terlipressin (0.66ug/min-2.66ug/min) ,dosage modified acorrding to blood pressure
16160830|NCT01697410|Drug|Norepinephrine|continuous infusion with dose 7.5ug/min-30ug/min,modified acorrding to blood pressure
16160831|NCT01697384|Drug|histrelin acetate|52 week implant
16160832|NCT01697371|Radiation|Proton|"All patients will receive 3 fractions in no more than 14 days at the following levels: Level I = 12 Gy per fraction, total dose=36 Gy.
~Level II = 16 Gy per fraction, total dose 48 Gy. Level III = 20 Gy per fraction, total dose 60 Gy. The dose per fraction to the PTV will start at dose level I (12 Gy), but may vary from 12 Gy to 20 Gy in 3 fractions over 14 days in 4 Gy increments"
16160833|NCT01697371|Radiation|Proton Radiation|
16160834|NCT01697358|Device|Spinal Cord Stimulation (SCS)|Spinal Cord Stimulation (SCS) using the Medtronic Specify 5-6-5 multicolumn surgical lead. Subjects will undergo an SCS screening test and, if successful, an implantable neurostimulation system implant. Any SCS group subject not implanted will continue to be treated with OMM and will be followed as part of the SCS group.
16160835|NCT01697358|Drug|Optimal Medical Management (OMM)|The investigator and subject will determine an individual OMM treatment plan, which should include non-investigational pharmacologic agents and/or therapies.
16160836|NCT01697345|Drug|Testosterone|
16160837|NCT01697332|Drug|Hyperpolarized 129Xe gas|800cc of a gas mixture containing 129Xe and nitrogen will be inhaled by a subject. The subject will hold their breath for no more than 16 seconds while a MRI scan is performed. The gas mixture can contain between 20 and 100% xenon.
16160838|NCT01697319|Drug|BMN 110|Drug will be delivered through a 4 hour (approximate) IV infusion at a dosage amount of 2.0 mg/kg/week for up to 144 weeks of treatment.
16160839|NCT01697306|Drug|Gemcitabine 2 g|six weekly instillations of gemcitabine (Gemzar, Eli Lilly SpA), 2.000 mg diluted in 50 cc of saline
16160840|NCT01697306|Drug|BCG Vaccine|six weekly instillations of Connaught strain BCG (Immucyst) 1/3 dose (27 mg) diluted in 50 cc of saline
16160841|NCT01697293|Drug|Cyclophosphamide|Given IV
16160842|NCT01697293|Drug|Doxorubicin Hydrochloride|Given IV
16160843|NCT01697293|Other|Laboratory Biomarker Analysis|Correlative studies
16160844|NCT01697293|Drug|Paclitaxel|Given IV
16160845|NCT01697293|Procedure|Therapeutic Conventional Surgery|Undergo modified radical mastectomy, radical mastectomy, segmental mastectomy or lumpectomy with an axillary lymph node dissection or biopsy
16160846|NCT01697293|Drug|Triciribine Phosphate|Given IV
16160847|NCT01697280|Behavioral|Vaccine promotion messages|"The messages will be low-literacy, of very short duration, and will be delivered with the help of pictorial cards. These educational messages will include the following messages:
~Vaccines can save a child's life
~Children who are immunized on time are less likely to become ill
~Unimmunized children can become disabled for life
~Photograph of the nearest EPI center where vaccines are offered free of charge, as well as its address and timings."
16160848|NCT01697280|Other|Vaccination Verification.|EPI vaccinators/volunteers will identify and record details of un/under-vaccinated children less than 12 months old in households they visit during an NID, and update immunization registries maintained at the local EPI centers so these children can be reached in subsequent outreach activity.
16160849|NCT01697280|Other|Distribution of Plastic Pouches to retain vaccination card|At the start of this project, all EPI centers in the study areas will be provided with plastic pouches to be given to parents of all children coming to EPI centers for vaccinations. These pouches will be used to store a child's immunization card.
16160850|NCT01697267|Biological|Rituximab|Rituximab IV infusion 1000 mg x 1 dose at months 4, 8, 12, 16 and 20 and glucocorticoids. Four - six hour infusion. Treatment with rituximab will cease at month 20.
16161027|NCT01695941|Other|Laboratory Biomarker Analysis|Correlative studies
16160851|NCT01697267|Drug|Azathioprine|"Oral dosage form. Target dose is 2mg/kg; maximum daily dose is 200mg. This should be continued until month 24. The dose should then by reduced by 50% and azathioprine completely withdrawn at month 27.
~The dose should be rounded down to the nearest 25mg. The dose may vary on alternate days e.g. 100mg one day, 150mg the next for patients on an overall dose of 125mg daily.
~If patients are aged over 60 years, reduce the dose by 25%. If patients are aged over 75 years, reduce the dose by 50%."
16160852|NCT01697241|Other|Supervised exercise|Patients in the exercise groups will receive two types of exercise, delivered on separate days. One type of exercise is individualized, goal-based neuromuscular training (NEMEX-TJR) in groups with progression guided by the patient's neuromuscular function. The other type of exercise is individualized, intensive resistance training (RT) in groups with each exercise progression guided by load. Each of the two types of exercise will be offered weekly during the 12 week intervention period in sessions lasting 60-70 minutes. Thus, the entire exercise intervention consists of 24 sessions
16160853|NCT01697241|Other|Patient education|The patient education program is designed to educate the patients about hip osteoarthritis during 3 sessions of 90 min. duration
16160854|NCT01697228|Dietary Supplement|Vitamin D|
16160855|NCT01697215|Other|AirWave|
16160856|NCT01697189|Behavioral|Fatigue management training|Experimental group took part in a single half-day (4 hours) fatigue management training grounded on Problem Based Learning (PBL).
16160857|NCT01697150|Device|DiAs Diabetes Assistant Wearable Artificial Pancreas Platform|Subjects will spend two nights in a non hospital setting while the Artificial Pancreas Device System is remotely monitored from an adjacent room. Artificial Pancreas Device System is composed of an Android-based cell phone platform operating with a DexCom sensor, OmniPod Insulin Management System and an Insulet iDex remote controller. Communication runs on a tablet. The Control to Range software will be capable of transmitting patient state data to a remote monitoring device. The subject will be trained on the open loop features of the cell phone platform user interface: DexCom displays, Insulin injection history display, bolus function. The subject may use the study pump per his/her usual home regimen and may make adjustments to his/her insulin based on symptoms or SMBG readings.
16160858|NCT01697137|Behavioral|Participant Video and Provider Cueing|Participants will watch a 5-minute video and then select a question about donation to discuss with their primary care provider (provider cueing).
16160859|NCT01697124|Behavioral|SPARK-EC|The CIA study was a 5 month physical activity change intervention that utilized the SPARK-EC curriculum as the intervention. The SPARK-EC curriculum was designed to be a quality, comprehensive physical activity program for the preschool setting. Pre-and Post-intervention assessments were conducted
16160860|NCT01697111|Drug|EE20/DRSP(BAY86-5300)|One tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day
16160861|NCT01697111|Drug|Placebo|One tablet (no active ingredient) / day and one tablet [0.02 mg of ethinylestradiol (β-CDC) and 3 mg of drospirenone] / day, for the first 24 weeks and the later 28 weeks, respectively
16160862|NCT01697111|Drug|Dienogest|Dienogest 1mg twice a day (bid)
16160863|NCT01697098|Drug|Dexamethasone 24 hours|
16160864|NCT01697098|Drug|Dexamethasone 12|
16160865|NCT01697085|Dietary Supplement|Sea buckthorn oil|
16160866|NCT01697085|Dietary Supplement|Placebo oil|
16160867|NCT01697072|Drug|Rilotumumab|Rilotumumab is a fully human monoclonal antibody immunoglobulin G, type 2 (IgG2) against human hepatocyte growth factor/scatter factor (HGF/SF) that blocks binding of HGF/SF to its receptor MET, inhibiting HGF/MET-driven activities in cells.
16160868|NCT01697072|Other|Placebo|Placebo
16160869|NCT01697072|Drug|Epirubicin|Epirubicin is an anthracycline cytotoxic agent.
16160870|NCT01697072|Drug|Cisplatin|Cisplatin is a non-cell cycle specific chemotherapeutic agent.
16160871|NCT01697072|Drug|Capecitabine|Capecitabine is an oral fluoropyrimidine.
16160872|NCT01697059|Drug|Piperacillin + Amoxicillin|
16160873|NCT01697046|Drug|Truvada and Isentress|"Subjects with reported high-risk behavior (and anticipated future high-risk behavior) but no exposure in the immediate past will be the focus of this study.
~Participants will be prescribed raltegravir 400 mg BID + Truvada once daily. All study participants will receive a 4-days starter pack. Study participants will be instructed to start study drugs if they expect or experience an exposure of any mucous membrane (oral, urethral, anal) to semen. Subjects who expect or experience these exposures will be instructed to take 1 pill of Raltegravir 400mg and one pill of truvada, followed by a second dose of Raltegravir 12 hours later. From the second day onward, participants will be instructed to take Raltegravir 400 mg BID + Truvada once daily. The first dose should be taken no more than 6 hours before or 6 hours after the expected or actual exposure and continued for 28 days."
16160874|NCT01697020|Drug|Mercaptopurine 20mg/ml oral suspension|50mg
16160875|NCT01697020|Drug|Mercaptopurine 50mg tablet|50mg
16160876|NCT01697007|Biological|HIVIS DNA vaccine|
16160877|NCT01697007|Device|Zetajet|
16160878|NCT01697007|Device|Derma Vax Electroporation|
16160879|NCT01697007|Biological|Modified Vaccinia Ankara (MVA-CDMR)|
16160880|NCT01696994|Other|Laboratory Biomarker Analysis|Correlative studies
16160881|NCT01696994|Other|Screening Questionnaire Administration|Undergo questionnaire assessments
16160882|NCT01696994|Procedure|Ultrasonography|Undergo TVU
16160883|NCT01696981|Other|Screening Questionnaire Administration|Undergo questionnaire assessments
16160884|NCT01696981|Procedure|Sigmoidoscopy|Undergo a flexible sigmoidoscopy
16160885|NCT01696968|Other|Screening Questionnaire Administration|Undergo questionnaire assessments
16160886|NCT01696968|Procedure|X-Ray Imaging|Undergo a chest x-ray
16160887|NCT01696955|Biological|Cetuximab|Given IV
16160888|NCT01696955|Other|Laboratory Biomarker Analysis|Correlative studies
16160889|NCT01696955|Drug|Tivantinib|Given PO
16160890|NCT01696942|Drug|Cimzia|400 mg subcutaneously at weeks 4, 6, and 8 after surgery, and then every 4 weeks
16160891|NCT01696942|Drug|Mesalamine|mesalamine 800 mg orally three times daily
16160892|NCT01696929|Drug|Tocilizumab|"Therapeutic/Pharmacologic Class of Drug:
~Tocilizumab is a recombinant humanized anti-human interleukin-6 (IL-6) receptor monoclonal antibody of the immunoglobulin (Ig) gamma-1 subclass.
~Type of Dosage Form:
~Concentrate for solution for infusion.
~Route of Administration:
~Intravenous (i.v.) infusion."
16160893|NCT01696916|Procedure|6-minute walking test|submaximum exercise test
16160894|NCT01696903|Procedure|Pancreaticojejunostomy technique|The anastomosis between jejunum and remnant pancreas has a pivotal impact on the incidence of postoperative pancreatic fistula. by this novel technique the remnant pancreas is intubated into the jejunum without extensive manipulation.
16160895|NCT01696890|Device|integrated follow-up|close interaction between HF clinic and general practitioner in response to telemonitoring alerts. All subjects will be monitored daily for heart rate, blood pressure, and body weight, after which these data are transferred automatically to the general practitioner. This device is custom-made.
16160896|NCT01696890|Device|standard care|no interaction between HF clinic and general practitioner in response to telemonitoring alerts. General practitioner is responsible for adaptations to therapy according to clinical presentation of the patient.
16160897|NCT01696877|Drug|degarelix acetate|Degarelix Acetate is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by decreasing the amount of testosterone in the body,which the tumor needs to grow.
16160898|NCT01696877|Drug|Cyclophosphamide|Cyclophosphamide as a potent enhancer of immune responses to GVAX. cyclophosphamide is used as an immune suppressor in many autoimmune disorders.
16160899|NCT01696877|Drug|GVAX|GVAX is granulocytemacrophage -colony stimulating factor -secreting allogeneic cell-based vaccine as immunotherapy for prostate cancer
16160900|NCT01696864|Device|Hand tutor rehabilitation device|A rehabilitation device for the hand
16160901|NCT01696864|Device|Arm tutor rehabilitation device|A rehabilitation device for the arm
16160902|NCT01696851|Other|tests and questionnaires|lung test, depression and self-efficacy questionnaires and Functional testing.
16160903|NCT01696838|Other|electroacupuncture|Patients receive electroacupuncture for 30 minutes with a stimulation frequency of 2 /100 Hz and a stimulation intensity varying from 0.1 to 1.0 mA.3 times per week,the duration is 12 weeks.
16160904|NCT01696838|Other|moxibustion|patients receive herbs-partitioned moxibustion for 2 cones，3 times a week for 12 weeks.
16160905|NCT01696825|Drug|Diazepam tablet, 5 mg, vaginal|Diazepam tablet, 5 mg, moistened and inserted vaginally
16160906|NCT01696825|Drug|Diazepam Suppository, 5 mg, vaginal|Compounded diazepam 5 mg suppository administered vaginally
16160907|NCT01696825|Drug|Diazepam Cream, 5 mg, Vaginal|Compounded diazepam cream, 5 mg, inserted vaginally
16160908|NCT01696812|Procedure|electrode position|
16160909|NCT01696799|Drug|Econazole Nitrate|
16160910|NCT01696799|Drug|placebo|
16160911|NCT01696786|Procedure|Oocyte cryopreservation|Oocyte (egg) cryopreservation (freezing) to preserve fertility
16160912|NCT01696773|Other|Tangerine tomato juice|Post-prandial feeding study
16160913|NCT01696773|Other|Red tomato juice|Post-prandial feeding study
16160914|NCT01696760|Drug|acetylsalicylic acid|325 mg twice a day
16160915|NCT01696760|Drug|enoxaparin|40 mg once daily
16160916|NCT01696760|Device|PCD|Wear PCD (Flowtron calf compression). Patients will continue to use PCDs for the duration of their hospitalization. If patients refuse to wear the PCDs, they will be withdrawn from the study.
16160917|NCT01696734|Drug|Domperidone|Given PO
16160918|NCT01696734|Other|Questionnaire Administration|Ancillary studies
16160919|NCT01696721|Other|No intervention|
16160920|NCT01696708|Other|31-Phosphorus RMN Spectroscopy|
16160921|NCT01696695|Drug|Capecitabine|First line capecitabine based oral tablet treatment in line with the effective Summary of Product Characteristics
16160922|NCT01696695|Drug|Chemotherapy|First line chemotherapy according to effective official Summary of Product Characteristics. The study protocol does not specify any particular therapy.
16160923|NCT01696682|Procedure|Narrowed Gastric Conduit|The gastric conduit will be formed much narrower in the intervention arm during minimally invasive esophagectomy
16160924|NCT01696682|Procedure|Widened Gastric Conduit|A widened gastric tube will be formed during the surgery
16160925|NCT01696669|Drug|Chemotherapy|"Vincristine, 2 mg/m^2 IV bolus, day 1.
~Doxorubicin: 75 mg/m^2 per cycle, or 25 mg/m^2/day x 3 days, IV infusion, 1 hour (after dexrazoxane administration at the dose of 10:1).
~Dexrazoxane: administered at a dose of 10:1, before doxorubicin only in adults.
~Cyclophosphamide: 2100 mg/m^2 IV infusion, 6 hours, with MESNA protection, days 1 and 2.
~MESNA: used with cyclophosphamide and ifosfamide. The total daily dose of MESNA is equivalent to at least 60% of the daily dose of cyclophosphamide or ifosfamide.
~G-CSF: 5 micrograms/kg/day SC. It starts 24 hours after the last dose of chemotherapy and continues until the absolute neutrophil count is ≥ 750 mm^3/L.
~Ifosfamide: 1800 mg/m^2/day IV infusion, 1 hour, days 1-5 of each cycle (9,000 mg/m^2 total maximum dose).
~Window phase in high-risk patients (21-days cycle):
~Gemcitabine: 1000 mg/m^2 IV, 90 minutes on day 1 and 8.
~Docetaxel 100 mg/m^2, 2-3 hour infusion on day 8."
16160926|NCT01696669|Procedure|Surgery|Surgical intervention aiming to completely resect the tumor with negative margins.
16160927|NCT01696669|Radiation|Radiotherapy|On the primary tumor bed in case of unresectable tumors, resected tumors with inadequate margins, or those with histologic response <90%. Patients will receive radiotherapy 21 days after the completion of chemotherapy.
16160928|NCT01696656|Drug|Drug prescription pattern|Type, dosage, administration route and frequency of prescription of all adjuvant pharmacologic agents will be transcribed from hospital records
16160929|NCT01696643|Drug|CB-5945|
16160930|NCT01696643|Drug|Placebo|
16160931|NCT01696630|Drug|Xenon|
16160932|NCT01696630|Drug|Desflurane|
16160933|NCT01696617|Drug|Aripiprazole 6-week group|
16160934|NCT01696617|Drug|Aripiprazole 8-week group|
16160935|NCT01696604|Drug|GSK2849466|GSK2849466 will be available as capsules of dose strengths 0.01, 0.1, 1.0, and 2.5 mg.
16160936|NCT01696604|Drug|Placebo|Matching placebo capsules will be available.
16160937|NCT01696591|Biological|NEUROSTEM®-AD|NEUROSTEM®-AD was administered to eligible subjects in the early part of the Phase I clinical study. In this follow-up study, no intervention will be performed.
16160938|NCT01696578|Behavioral|BF-CBT and group physiotherapy|Multivitamin+10 individual therapy sessions (BF-CBT) and 10 group therapy sessions (physical exercises) on a weekly basis
16160939|NCT01696565|Drug|PG2|Injectable
16160940|NCT01696552|Procedure|TKR with Positioning Guides (PSPG)|TKR (Vanguard Total Knee System, Biomet) with PSPG (Signature, Materialise) technique
16160941|NCT01696552|Procedure|TKR with Conventional Technique|TKR (Vanguard Total Knee System, Biomet) with Conventional Technique
16160942|NCT01696539|Behavioral|Walking Intervention|Participants are provided with the current standard of prostate cancer care, and are additionally encouraged to walk 10,000 steps per day, as measured by pedometers provided at start of intervention. Once a week, participants will take part in a group walk with 7-8 other participants and a research nurse. Participants are also encouraged to keep a walking journal, in which they record the number of steps they walk each day. This journal is submitted to investigators at the end of the intervention period.
16160943|NCT01696539|Other|Standard of Care|Participants are provided with the current standard of prostate cancer care, but are not assigned to a physical activity intervention.
16160944|NCT01696526|Other|vitamin D fortified fish|fish containing vitamin D3
16160945|NCT01696526|Other|conventional fish|fish containing low concentrations of vitamin D3
16160946|NCT01696513|Procedure|Suction|
16160947|NCT01696513|Procedure|Subcision|
16160948|NCT01696500|Drug|Intravenous immunoglobulin|
16160949|NCT01696487|Dietary Supplement|High oral Fructose challenge (150g per day for 28 days)|
16160950|NCT01696474|Drug|Bortezomib|
16160951|NCT01696461|Drug|Plerixafor|
16160952|NCT01696448|Dietary Supplement|CAR-191|Patients will be randomized to the CAR-191 intervention group in a 3:1, CAR0-191:placebo ratio. There will be 30 patients in the CAR-191 treatment group.
16160953|NCT01696448|Other|Placebo|Patients will be randomised in a 3:1 ratio. There will be 10 patients in the placebo group.
16160958|NCT01696422|Biological|Dengue 1,2,3,4 (attenuated) vaccine|Dose 1000 PFU per virus (1,2,3,4) Route:subcutaneous
16160959|NCT01696422|Biological|TetraVax-DV Vaccine - Admixture TV003|Dose 1000 PFU per virus (1,2,3,4) Route: subcutaneous
16160960|NCT01696422|Other|Placebo|Route:subcutaneous
16160961|NCT01696409|Dietary Supplement|400 IU vitamin D3|Take 400 IU once/day for 2 months
16160962|NCT01696409|Dietary Supplement|2000 IU vitamin D3|2000 IU vitamin D3 once/day for 2 months
16160963|NCT01696396|Drug|Abrilumab|Administered by subcutaneous injection.
16160964|NCT01696396|Drug|Placebo|Placebo matching to abrilumab administered by subcutaneous injection
16160965|NCT01696383|Drug|Travoprost 0.004%/Timolol 0.5% Fixed Combination (DuoTrav)|One drop self-administered topically to the study eye(s) once daily every evening at 8:00 pm for 12 weeks
16160966|NCT01696370|Drug|Trimetazidine|Trimetazidine 20mg three times per day for 3 months
16160967|NCT01696370|Other|Placebo capsule|one capsule three times per day for 3 months
16160968|NCT01696357|Device|Automated Device for Asthma Monitoring (ADAM)|Both groups of adolescents (asthma/non-asthma)wore a prototype ADAM device for 7 days as they went about their usual daily activities. At night, the device continued to monitor symptoms as it was placed in close proximity to the adolescent's head during sleep. The asthma group answered survey questions about the status of their symptoms and their usage of asthma medication every morning and every evening- entering their answers directly onto the monitoring device.
16160969|NCT01696344|Procedure|PVAI|
16160970|NCT01696344|Procedure|PVAI + ablation of extraPV triggers|PVAI followed by ablation of extra-PV triggers originating from sites other than pulmonary veins such as superior vena cava, ligament of Marshall, coronary sinus, crista terminalis, left atrial (LA) posterior wall and LA appendage
16160971|NCT01696331|Behavioral|Text Message Reminder|Sent TM reminder at beginning and end of each month that corresponded to required lab frequency. Patients were able to send autoresponses.
16160972|NCT01696318|Behavioral|Support for the Family Health Team|Participation in physical educator, dietitian and pharmacist in primary health care
16160973|NCT01696305|Device|Hyalobarrier|
16160974|NCT01696305|Device|Guardix-SG|
16160975|NCT01696279|Drug|Lanthanum Carbonate|Lanthanum Carbonate 1500 mg to 3000 mg powder will be administered orally.
16160976|NCT01696279|Drug|Calcium Carbonate|Calcium carbonate will be administered orally at a total daily dose based on standard clinical practice. The total daily dose may be adjusted as appropriate, until the target serum phosphorus level is achieved or until a maximum daily dose of 6500 mg is reached.
16160977|NCT01696266|Other|No treatment given|Patients will be asked to complete a two-part patient self-assessment questionnaire (SAQ) comprising a retrospective cross-sectional evaluation (Part 1), and a prospective observational evaluation (Part 2).
16160978|NCT01696240|Drug|Placebo|Capsule, appears identical with udenafil, will be provided by Dong-A pharmaceutical company. Patients will receive 50 mg of placebo drug two times a day for 4 weeks, and then the dosage will be escalated to 100 mg two times a day for next 8 weeks.
16160979|NCT01696240|Drug|Udenafil (Zydena)|Udenafil (Zydena), a newly developed PDE-5 inhibitor by Dong-A pharmaceutical company, will be administered to patients in this group, 50 mg two times a day for 4 weeks, and then the dosage will be escalated to 100 mg two times a day for next 8 weeks.
16160980|NCT01696227|Drug|Nissle 1917|Uropathogens will be challenged to share the same in vitro environment with Nissle 1917.
16160981|NCT01696214|Drug|Fluticasone 250 mg/salmeterol 50 mg|Drug: Fluticasone 250 mg/salmeterol 50 mg Participants will be assigned to a 24 week treatment with inhaled fluticasone/salmeterol or matching placebo
16160982|NCT01696214|Drug|Montelukast 10mg|Participants will be assigned to montelukast once a day for 24 weeks.
16160983|NCT01696214|Drug|Theophylline 400 mg|Participants will be assigned to theophylline once a day for 24 weeks
16160984|NCT01696214|Drug|ipratropium|Participants will be assigned to ipratropium 2.5 mL of 0.02% solution via mini nebulizer 3 times a day day for 24 weeks.
16161028|NCT01695941|Biological|Rituximab|Given IV
16161029|NCT01695928|Device|Extracorporeal shockwave therapy|1000 impulses
16161030|NCT01695928|Device|ESWT placebo|0 impulses, acoustic effect
16161031|NCT01695915|Procedure|Transabdominal ultrasound|Transabdominal ultrasound are applied to the subjects every third hour during the study and every hour for three hours after a bowel movement.
16161032|NCT01695902|Drug|Levosert-20|
16160985|NCT01696201|Behavioral|Exercise group|"Supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 9 to 38). Each session consists of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training.
~Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60 of maximal heart rate. All subjects wore a heart rate (HR) monitor (Polar FT7) during the training sessions to ensure that exercise intensity was light to moderate."
16160986|NCT01696188|Device|interscalene nerve catheter|
16160987|NCT01696162|Other|Algorithm based Exercise Videos|The algorithm will adjust the exercises in each session based upon the participant's feedback.
16160988|NCT01696162|Other|PDF Exercise Sheets|A sheet of six exercises with descriptions on how to perform them properly
16160989|NCT01696162|Other|Limited Exercise Videos|Video of 6 exercises that provide instruction on how to perform the exercises
16160990|NCT01696149|Device|transcutaneous electrical nerve stimulation|All subjects participated, randomly, in a 4 Hz TENS session, a 110 Hz TENS session, and a control (off-TENS) session. Each session consisted of a 20- minute stimulation period and a 10-minute follow up period.
16160991|NCT01696136|Device|Cardiac ablation for Atrial Fibrillation|Cardiac ablation for Atrial Fibrillation
16160992|NCT01696123|Drug|MLC601|It was described
16160993|NCT01696110|Drug|Bivalirudin|Patients would be given anticoagulant therapy with bivalirudin in acute myocardial infarction during emergency PCI operation.
16160994|NCT01696110|Drug|heparin|heparin monotherapy
16160995|NCT01696110|Drug|heparin plus tirofiban|combined use of heparin and tirofiban during PCI
16160996|NCT01696097|Behavioral|DASH diet counseling|Comparison of protein source (chicken and fish vs. pork) as part of DASH diet on blood pressure regulation and blood lipids.
16160997|NCT01696084|Drug|CPX-351|First induction: 100 units/m2 by 90-minute IV infusion on Days 1, 3, 5. Second induction: 100 units/m2 by 90-minute IV infusion on Days 1 and 3. Consolidation therapy: 65 units/m2 by 90-minute IV infusion on Days 1 and 3.
16160998|NCT01696084|Drug|7+3 (cytarabine and daunorubicin)|"First induction: 7+3 was administered as: cytarabine at a dose of 100 mg/m2/day on Days 1 through 7 by continuous infusion, and daunorubicin at a dose of 60 mg/m2/day on Days 1, 2, and 3.
~Second induction: 5+2 was administered as: cytarabine at a dose of 100 mg/m2/day on Days 1 through 5 by continuous infusion and daunorubicin at a dose of 60 mg/m2/day on Days 1 and 2.
~Consolidation therapy: 5+2 was administered as: cytarabine at a dose of 100 mg/m2/day on Days 1 through 5 by continuous infusion, and daunorubicin at a dose of 60 mg/m2/day on Days 1 and 2."
16160999|NCT01696071|Drug|Tiotropium 5 mcg qd|2 puffs (2.5 mcg each) in the evening 5 mcg in total and 2 puffs of matching placebo in the morning
16161000|NCT01696071|Drug|Tiotropium 2.5 mcg bid|2 puffs (1.25 mcg each) twice daily, in the evening and in the morning, 5 mcg in total
16161001|NCT01696058|Drug|Tiotropium|marketed product
16161002|NCT01696058|Drug|Placebo matching Olodaterol|one dose
16161003|NCT01696058|Drug|Tiotropium|marketed product
16161004|NCT01696058|Drug|Olodaterol|one dose
16161005|NCT01696045|Biological|Ipilimumab|
16161006|NCT01696032|Drug|SGI-110|
16161007|NCT01696032|Drug|Treatment of Choice (topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine)|Investigator chose to treat with either topotecan, pegylated liposomal doxorubicin, paclitaxel, or gemcitabine
16161008|NCT01696032|Drug|Carboplatin|
16161009|NCT01696019|Other|Fast walking|Participants assigned to this group met with two group leaders three times per week in the morning in Jing An Park and were encouraged to walk quickly around a 400 meter circular route. Each session consisted of 10 minutes of warm-up stretching, 30 minutes of brisk walking, and 10 minutes of cool-down exercises. Prior to the first session, each participant was given a pedometer with their name on it. They were asked to take 100 steps and the sensitivity and positioning of the pedometer was adjusted to assure accurate measurement. At the termination of each session, the pedometers were collected and the number of steps taken by each participant at that session recorded. A record of the number of steps taken for every participant at each session over the 40 week period was maintained.
16161010|NCT01696019|Other|Tai Chi|Participants assigned to this group met with a Tai Chi master and assistant three times per week in the morning in Jing An Park or at a nearby gymnasium depending on weather conditions. Each session included 20 min of warm-up exercises (lower back and hamstring stretching, gentle calisthenics, and balance training), 20 min of Tai Chi practice, and 10 min of cool-down exercises.
16161011|NCT01696019|Other|Intellectual stimulation|Participants assigned to this group met with a group leader and an assistant for one hour three times a week in the morning at the neighborhood community center. Although direction was initially given regarding subjects for discussion, the participants decided on their own to organize and select topics themselves.
16161012|NCT01696019|Other|Contact and testing only|
16161013|NCT01695993|Device|Acupressure bands|Bilateral acupressure wrist bands
16161014|NCT01695993|Other|Expectancy-neutral handout|The expectancy neutral handout has neutral information regarding the acupressure bands
16161015|NCT01695993|Behavioral|Expectancy-neutral MP3|Patients will be given a portable MP3 player and relaxation MP3 that is about 12 minutes in length with a flute music background and guided imagery.
16161016|NCT01695993|Other|Expectancy-enhancing handout|The expectancy enhancing handout has expectancy-enhancing information regarding the acupressure bands
16161017|NCT01695993|Behavioral|Expectancy-enhancing MP3|Patients will be given a portable MP3 player and relaxation MP3 that is about 12 minutes in length with a flute music background and guided imagery. It also has expectancy-enhancing information regarding the acupressure bands.
16161018|NCT01695980|Procedure|ETT with non modified retractor|adenotonsillectomy
16161019|NCT01695980|Other|LMA with modified retractor|LMA with modified retractor
16161020|NCT01695967|Procedure|turbinate cauterization|
16161021|NCT01695954|Drug|Pitavastatin|Pitavastatin 2 mg tablets taken at bedtime in Arm A and in the morning in Arm B.
16161022|NCT01695954|Drug|Darunavir|Darunavir 400 mg tablets x 2 taken daily in Arm B
16161023|NCT01695954|Drug|Ritonavir|Ritonavir 100 mg tablets taken daily in Arm B
16161024|NCT01695954|Drug|Efavirenz|Efavirenz 600 mg tablets taken at bedtime in Arm A
16161025|NCT01695941|Drug|Alisertib|Given PO
16161026|NCT01695941|Drug|Bortezomib|Given SC
16161034|NCT01695876|Drug|AMG 357|Oral administration available in varying dose strength.
16161035|NCT01695876|Drug|Placebo|Matching placebo to AMG 357 containing no active drug
16161036|NCT01695863|Drug|comparing 2 drugs on their effect on the bowel preparation for colonoscopy|the effects of the drug on the colon preparation for colonoscopy
16161037|NCT01695850|Drug|MZRW|Patients are instructed to dissolve a sachet of granules (7.5g) in 150ml of hot water; they take this solution orally twice daily for 8 weeks.
16161038|NCT01695850|Drug|Senna|Patients are instructed to take 2 tablets at the bedtime for 8 weeks.
16161039|NCT01695850|Drug|placebo|The placebo MZRW is made from dextrin (76.03%), tea essence (23.61%), gardenin (0.02%) and caramel (0.34%) to achieve color, smell, taste and texture comparable to MZRW granules.The placebo Senna is made of starch and colour to achieve comparable appearance to Senokot.
16161040|NCT01695837|Behavioral|Group A: Dietary counseling month 0-6 Group B: Dietary counseling month 3-6|
16161041|NCT01695824|Device|LAA occluder|The procedure is performed under transesophageal echocardiographic (TEE) guidance. After a transseptal puncture is performed, a pigtail catheter is maneuvered into the LAA to perform an LAA angiogram. Through the use of a combination of this angiographic and TEE information, a Watchman device, ranging in size between 21 and 33 mm in diameter, is selected. The device comes prepackaged in a catheter-based delivery system that is advanced into the LAA through a 12F transseptal sheath (outer diameter, 14F). Proper positioning and stability of the device are verified by TEE and angiography before device release.
16161042|NCT01695824|Procedure|RFA ablation|The left atrium (LA) and pulmonary veins (PVs) were explored through a transseptal approach. Real-time three-dimensional (3D) LA maps were reconstructed by using a nonfluoroscopic navigation system (CARTO, Biosense-Webster Inc.). The ipsilateral left and right PVs were encircled in 1 lesion line by circumferential PV isolation. Radiofrequency energy was delivered at 43◦C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and was reduced to 43◦C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation speed of 17 mL/min. Each lesion was ablated continuously until the local potential amplitude decreased by >80% or RF energy deliveries exceeded 40 seconds. The endpoint of circumferential PV isolation was PV isolation; this was confirmed when Lasso mapping showed the disappearance of all PV potentials or the dissociation of PV potentials from left atrial activity.
16161043|NCT01695824|Drug|Warfarin|"Warfarin was discontinued in 45 days after procedure in case of no trombus by TE for Watchman group
~All patients in Warfarin group continued to receive Warfarin during hole study period with IMR from II to III."
16161044|NCT01695798|Biological|Injectable polio vaccine and Bivalent oral polio vaccine|"One dose of IPV given IM (arm, thigh) to infant aged 9-12 month after randomization.
~There will be two groups Chronic Malnourished group and Non-Malnourished group. Each group has two arms, which were randomized on IPV+bOPV and bOPOV alone"
16161045|NCT01695772|Drug|5-FU based doublet chemotherapy|Standard 5-FU based doublet chemotherapy. Protocol did not specify any particular chemotherapy regimen. The choice of 5-FU based doublet chemotherapy was as per standard of practice and the dosage of 5-FU based doublet chemotherapy was as per product labels.
16161046|NCT01695772|Drug|bevacizumab|5 mg/kg every 2 weeks, up to 12 cycles pre- and postoperatively
16161047|NCT01695759|Drug|Epoetin alpha|Participants assigned to this arm will receive two subcutaneous administrations per week of 50 UI/kg of Epoetin alpha (Eritromax), totaling 100 UI/kg/week. After the first four weeks of treatment, once a month throughout the study the medication dose can be adjusted by the study Investigator according to the laboratory results.
16161048|NCT01695759|Drug|Eprex|Participants assigned to this arm will receive two subcutaneous administrations per week of 50 UI/kg of Epoetin alpha (Eprex), totaling 100 UI/kg/week. After the first four weeks of treatment, once a month throughout the study the medication dose can be adjusted by the study Investigator according to the laboratory results.
16161049|NCT01695746|Drug|C.E.R.A.|Participants receiving 0.6 mcg/kg of C.E.R.A. once every two weeks for correction of anemia and conversion to C.E.R.A. dose 120, 200, or 360 mcg either once monthly; or 60, 100, or 180 mcg once every 2 weeks for maintenance of Hb according to local clinical practice or prescribing information will be observed.
16161050|NCT01695733|Biological|trivalent influenza vaccine|
16161051|NCT01695720|Procedure|VisionScope Imaging (VSI) Exam|The VisionScope Imaging (VSI) Exam [the system itself] is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination, visualization, and the capture of still and motion pictures of an interior cavity of the body through a natural or surgical opening.
16161052|NCT01695707|Drug|Pioglitazone|see Arm Description
16161053|NCT01695707|Drug|Placebo (for pioglitazone)|see Arm Description
16161054|NCT01695694|Behavioral|supporting positive and healthy relationships|
16161055|NCT01695694|Behavioral|community support group|
16161056|NCT01695681|Other|Gluten-free diet|Dietary advice by clinical dietitian
16161057|NCT01695668|Drug|Lotemax|Ophthalmic corticosteroid. It decreases inflammation of the eye
16161058|NCT01695668|Drug|Restasis|Restasis is an immunosuppressive agent. Cyclosporine may reduce inflammation in the eye.
16161059|NCT01695616|Drug|Placebo|
16161060|NCT01695616|Drug|Active drug|
16161061|NCT01695603|Device|Intellivent|
16161062|NCT01695590|Drug|PRLX 93936|PRLX 93936 administered IV 3 days a week (Monday, Wednesday and Friday) for 3 weeks followed by a 9 day rest period = 1 cycle, multiple cycles may be administered
16161063|NCT01695577|Other|Multidisciplinary evaluation and VR|Multidisciplinary assessment and evaluation and VR - Vestibular rehabilitation and balance training. Individually adjusted exercises in groups twice a week for two months. Home exercise program.
16161064|NCT01695577|Other|Multidisciplinary evaluation|Multidisciplinary assessment and evaluation.
16161065|NCT01695564|Device|LARIAT LAA|The LARIAT snare device is an over-the-wire device guided over the LAA to enable ligation of the LAA. The LARIAT can be opened and closed as desired for ideal positioning without risk of suture deployment.
16161066|NCT01695564|Device|WATCHMAN|The WATCHMAN is an expandable device deployed in the LAA via a trans-septal catheter. The implanted device has a self-expanding nitinol frame to secure it in the LAA. The fabric of the WATCHMAN device is permeable to blood.
16161067|NCT01695551|Other|Data Collection Forms|Participants will be asked questions relating to pre-procedure items and be asked to complete an MMSE. Subjects receive standard of care surgery. Data collected from procedures before, during and after surgery.
16161068|NCT01695538|Other|Yoga|The subjects will be asked to practice Yoga poses at least 3 times a week at home, although daily Yoga will be encouraged. Participants will be trained in breathing exercises, postures and meditation. Each time they practice yoga will be for 1 hour and include breathing exercises, postures and meditation.
16161069|NCT01695525|Other|Yoga|Includes breathing exercises, postures, and meditation. Participant practices yoga at their home a minimum of 3 times per week for 1 hour per time. Participation can last for up to 1 year.
16161070|NCT01695473|Drug|BKM120|Two weeks after confirmatory biopsy, patients will begin taking 100 mg/day of BKM120. BKM120 will be given at this dose level orally once daily for 14 days prior to radical prostatectomy. Radical prostatectomy will be performed on the day of the last dose of BKM120 at day 14. No further drug will be administered after radical prostatectomy. For unforeseen delays in OR scheduling, up to 7 additional days of BKM120 may be administered prior to surgery.
16161071|NCT01695460|Drug|D3 Vitamin ®|"Vitamin D and placebo supplied as tablets in containers of 124. The containers must be kept in dry and not too hot environment.
~All subjects randomized to vitamin D, will receive 100 micrograms of vitamin D3/day, equivalent to 4000 IU. Vitamin D is administered orally 1 time a day with breakfast."
16161072|NCT01695460|Drug|Placebo|
16161073|NCT01695447|Procedure|duct-to-mucosa|
16161074|NCT01695447|Procedure|invagination|
16161075|NCT01695447|Device|Internal stent|Internal stent may be used during pancreaticojejunostomy according to the situation of pancreatic duct and experience of the surgeon.
16161076|NCT01695434|Other|MRI|All subjects will undergo a MRI.
16161077|NCT01695421|Procedure|Medium-frequency alternating current|The subjects will receive stimulation to quadriceps and gastrocnemius for 5 days a week for 1 hour during 5 weeks. Electrical stimulation will be delivered through channel one with one electrode placed over the vastus medialis and the second electrode placed medial and distal to the greater trochanter. The channel two will be place on the gastrocnemius with one electrode positioned over the muscle belly and the second over the musculotendinous junction. The stimulus will be on for 10 seconds followed by a 30 second relaxation period at the first two weeks. Subsequently, the EMS stimulus will be on for 15 seconds followed by a 30 second relaxation period. The intensity will be turned up to the maximal tolerable intensity as reported by the subject (10-100 mA) observing muscular contraction.
16161078|NCT01695421|Procedure|Burst-modulated alternating current|The subjects will receive stimulation to quadriceps and gastrocnemius for 5 days a week for 1 hour during 5 weeks. Electrical stimulation will be delivered through channel one with one electrode placed over the vastus medialis and the second electrode placed medial and distal to the greater trochanter. The channel two will be place on the gastrocnemius with one electrode positioned over the muscle belly and the second over the musculotendinous junction. The stimulus will be on for 10 seconds followed by a 30 second relaxation period at the first two weeks. Subsequently, the EMS stimulus will be on for 15 seconds followed by a 30 second relaxation period. The intensity will be turned up to the maximal tolerable intensity as reported by the subject (10-100 mA) observing muscular contraction.
16161079|NCT01695421|Procedure|Placebo|The subjects will receive stimulation to quadriceps and gastrocnemius for 5 days a week for 1 hour during 5 weeks. Electrical stimulation will be delivered through channel one with one electrode placed over the vastus medialis and the second electrode placed medial and distal to the greater trochanter. The channel two will be place on the gastrocnemius with one electrode positioned over the muscle belly and the second over the musculotendinous junction. The stimulus will be on for 10 seconds followed by a 30 second relaxation period at the first two weeks. Subsequently, the EMS stimulus will be on for 15 seconds followed by a 30 second relaxation period. The intensity will be fixed on 5 mA.
16161080|NCT01695421|Procedure|Functional electrical stimulation|The subjects will receive stimulation to quadriceps and gastrocnemius for 5 days a week for 1 hour during 5 weeks. Electrical stimulation will be delivered through channel one with one electrode placed over the vastus medialis and the second electrode placed medial and distal to the greater trochanter. The channel two will be place on the gastrocnemius with one electrode positioned over the muscle belly and the second over the musculotendinous junction. The stimulus will be on for 10 seconds followed by a 30 second relaxation period at the first two weeks. Subsequently, the EMS stimulus will be on for 15 seconds followed by a 30 second relaxation period. The intensity will be turned up to the maximal tolerable intensity as reported by the subject (10-100 mA) observing muscular contraction
16161081|NCT01695382|Behavioral|Navigation|As per Arm description
16161082|NCT01695369|Device|Senofilcon A; Comfilcon A|Senofilcon A; Comfilcon A
16161083|NCT01695369|Device|Comfilcon A; Senofilcon A|Comfilcon A; Senofilcon A
16161084|NCT01695356|Drug|290-400 nm sunscreen|A broad UV spectrum sunscreen will be applied every 3 hours for 12 weeks. The affected surface will be covered with a 2 mg/cm^2 layer of the product as indicated on the affected areas of the face.
16161085|NCT01695356|Drug|290-800 nm sunscreen|A UV-visible light spectrum sunscreen will be applied every 3 hours for 12 weeks. The affected surface will be covered with a 2 mg/cm^2 layer of the product as indicated on the affected areas of the face.
16161086|NCT01695343|Biological|KB001-A|
16161087|NCT01695343|Drug|Placebo Comparator|
16161088|NCT01695330|Drug|Subcutaneous bortezomib|Bortezomib will be administered SC at a dose of 1.0 mg/m2. Doses are to be administered on days 1, 4, 8, and 11 of a 28-day cycle. All other drugs used in combination with the SC bortezomib as well as their doses and schedules will be at the discretion of the Principal Investigator.
16161089|NCT01695317|Drug|Acetyl-L-carnitine|Week 1: 500 mg x 3, Week 2-12: 500 mg x 6
16161090|NCT01695304|Other|Ceramic water filter|In total, 120 households with a child 4-10 months old will receive a Cera Maji ceramic water filter for treatment of drinking water at initial entry into the study (intervention group), and 120 households with a child 4-10 months old at initial entry into the study will not receive a ceramic water filter (control group). The study duration will be 6 months. All households in the control group will receive a Cera Maji ceramic water filter when the study ends.
16161091|NCT01695291|Drug|Minocycline|Participants randomized to minocycline will receive approximately 2 mg/kg/day, the FDA-approved dose for minocycline. Participants will take either minocycline or pill placebo for 12 weeks.
16161092|NCT01695291|Other|Placebo|A placebo pill will be administered twice a day (BID) for 12 weeks.
16161233|NCT01694043|Other|Healthy Foods|While watching the tv show, participants will receive a healthy snack to eat (grapes and baby carrots).
16234408|NCT01128322|Drug|Placebo|
16161093|NCT01695278|Behavioral|Telephone Counseling|Weekly telephone counseling intervention for 16 weeks, used to identify and overcome barriers to diabetes control and set goals for positive behavioral changes supplemented by monthly group classes on skill development.
16161094|NCT01695265|Other|Exercie oronasal breathing (ONB)|10 min at 50% of VO2 Peak achieve during a first incremental cardiopulmonary exercise test CPET using oronasal breathing (ONB)
16161095|NCT01695265|Device|Exercie nasal breathing through the FB|Device: Feel Breathe, restriction device ventilatory nasal The Feel Breathe (FB) consisted of a small adhesive strip that is place across the bridge of the nose during exercise. The FB was place following procedures for placement as indicated by the manufacture's directions, while the placebo nasal, was placed over the nostrils of the subject, without interfering nasal breathing; thus, nasal airflow resistance was not increase. 10 min at 50% of VO2 Peak achieve during a first incremental cardiopulmonary exercise test CPET using FeelBreathe device (FB)
16161096|NCT01695252|Other|MEMOS|Patient informed clinical outcomes supervision
16161097|NCT01695239|Drug|Ixekizumab|Administered SC
16161098|NCT01695239|Drug|Placebo|Administered SC
16161099|NCT01695239|Drug|Adalimumab|Administered SC
16161100|NCT01695226|Drug|celecoxib|pre-operative celecoxib (400 mg) twice daily for two to three weeks
16161101|NCT01695226|Drug|Placebo|pre-operative placebo twice daily for two to three weeks
16161102|NCT01695213|Procedure|uncemented total hip arthroplasty|
16161103|NCT01695200|Dietary Supplement|Omega-3 fatty acids|
16161104|NCT01695187|Drug|NB-001 (0.3%)|Topical administration at least five times throughout the day
16161105|NCT01695187|Drug|Placebo|
16161106|NCT01695174|Drug|Xifaxan|
16161107|NCT01695148|Dietary Supplement|β-Carotene Biofortified Maize Flour|
16161108|NCT01695148|Dietary Supplement|White Maize Flour|
16161109|NCT01695135|Drug|Abiraterone acetate|Abiraterone 1000 mg (4 x 250 mg tablets) taken orally once daily
16161110|NCT01695135|Drug|Placebo|Placebo (4 tablets) taken orally once daily
16161111|NCT01695135|Drug|Prednisone|Prednisone 5 mg tablet taken orally twice daily
16161112|NCT01695122|Drug|Valproic Acid|
16161113|NCT01695109|Drug|Liraglutide|sc injections of 0.6 mg Liraglutide daily for three continuous days.
16161114|NCT01695109|Drug|Placebo|0.9% NaCl, 0.2 ml
16161115|NCT01695096|Other|The Embryos will be cultured on a humidity free incubator|We will set the humidity level to 0.0% in the IVF incubator that will be used for culturing the Human embryos after ICSI procedure and we will monitor the outcome embryologically and clinically and record the results.
16161116|NCT01695096|Other|The Embryos will be cultured on a >95% humidity incubator|We will set the humidity level to 95% in the IVF incubator that will be used for culturing the Human embryos after ICSI procedure and we will monitor the outcome embryologically and clinically and record the results.
16161117|NCT01695070|Drug|Melatonin|4mg prolonged release melatonin oral tablets twice daily
16161118|NCT01695057|Drug|vorinostat|Given PO
16161119|NCT01695057|Procedure|therapeutic conventional surgery|Undergo surgery
16161120|NCT01695057|Other|laboratory biomarker analysis|Correlative studies
16161121|NCT01695044|Drug|PSMA ADC|PSMA ADC administered IV at 2.5 mg/kg Q3W for 8 cycles or 2.3 mg/kg Q3W for 8 cycles.
16161122|NCT01695031|Behavioral|Tailored asthma management program|web-based, computer-tailored asthma management intervention delivered every week for 4 weeks
16161123|NCT01695031|Behavioral|Generic web-based education|Generic, web-based asthma education
16161124|NCT01695005|Drug|LY3039478|Administered orally
16161125|NCT01695005|Drug|Prednisone|Administered orally
16161126|NCT01694992|Other|Early mobilization|The Intervention Group - Early Mobilization - will follow the early physiotherapy program within the first 24 - 48 hours after acute ischemic stroke, five times per week for 30 minutes plus time to spent out of bed (sitting).
16161127|NCT01694979|Other|Minimum expiration effort|Subjects perform a forced expiration at minimum effort
16161128|NCT01694979|Other|Moderate expiration effort|Subjects perform a forced expiration at moderate effort
16161129|NCT01694979|Other|Maximum expiration effort|Subjects perform a forced expiration at maximum effort
16161130|NCT01694966|Drug|Methylene Blue MMX®|
16161131|NCT01694966|Drug|Placebo|Sugar pill manufactured to mimic Methylene Blue MMX® tablet.
16161132|NCT01694927|Procedure|Autologous Mesenchymal Stem Cells|Expanded Intralesional Autologous Mesenchymal Stem Cells Transplantation
16161133|NCT01694914|Procedure|corneal graft|
16161134|NCT01694888|Other|lecture|Teaching documentation skill using lecture method
16161135|NCT01694875|Device|APTIMA HPV Assay|In Vitro Diagnostics Assay
16161136|NCT01694862|Procedure|Integrated FP/PNC service delivery|The intervention uses a procedural tool building on existing MoH procedures. It has nine components: strengthening protocols, guidelines and training materials for integrated HIV-SRH care; training, mentorship; developing a mentoring and supervisory package; improving provider capacity; ensuring availability of minimum levels of equipment and supplies for integrated services; support supervision; organizational change (including reviewing use of available rooms) and role clarification; improving availability of IEC/BCC materials on FP and HIV; strengthening the referral system between FP and ART and the data collection and recording systems.
16161137|NCT01694849|Drug|GFT505 80mg|
16161138|NCT01694849|Drug|GFT505 120mg|
16161139|NCT01694849|Drug|Placebo|
16161140|NCT01694836|Biological|s.c. injection|3 years of therapy followed by 2 years (seasons) of treatment-free observational period
16161141|NCT01694823|Drug|CS-ACI|"Procedure: Self-control. Cells Sheet-Autologous Chondrocyte Implantation(CS-ACI) includes an arthroscopy for harvesting of cartilage 6-8 weeks prior to the open cartilage surgery. Other Names:
~Cells Sheet-Autologous Chondrocyte Implantation （CS-ACI）"
16161142|NCT01694810|Drug|2% NVN1000 Topical Gel|2% NVN1000 Topical Gel once daily for 4 weeks
16161143|NCT01694810|Drug|4% NVN1000 Topical Gel|4% NVN1000 4% Topical Gel applied once daily 4 weeks
16161144|NCT01694810|Drug|8% NVN1000 Topical Gel|8% NVN1000 Topical Gel applied once daily for 4 weeks
16161145|NCT01694810|Drug|Vehicle Topical Gel|Vehicle Topical Gel applied once daily
16161146|NCT01694797|Drug|Metoprolol Succinate|
16161672|NCT01690520|Drug|Mycophenolate Mofetil|Given IV or PO
16161147|NCT01694784|Behavioral|Quantitative Information Sheet|Patients will read an information sheet about one of the three exemplar services in one of four presentations: quantitative, qualitative, narrative, or framed. In the quantitative information sheet, harms will be communicated in absolute risks with accompanying fact box (i.e. box containing key facts and rates). In addition to information about harms, the information sheet will include the following information: a description of the disease to be detected and the screening test, a description of the possible benefits of the service, and a statement encouraging decision. As an adjunct to numerical information in paragraph form, fact boxes engage individuals to process information and improve understanding.
16161148|NCT01694784|Behavioral|Qualitative Information Sheet|Patients will read an information sheet about one of the three exemplar services in one of four presentations: quantitative, qualitative, narrative, or framed. In the qualitative information sheet, harms will be communicated using verbal descriptors. In addition to information about harms, the information sheet will include the following information: a description of the disease to be detected and screening test, a description of the possible benefits of the service, and a statement encouraging decision.
16161149|NCT01694784|Behavioral|Narrative Information Sheet|Patients will read an information sheet about one of the three exemplar services in one of four presentations: quantitative, qualitative, narrative, or framed. In the narrative information sheet, harms will be communicated using patient narratives with accompanying fact box. In addition to information about harms, the information sheet will include the following information: a description of the disease to be detected and screening test, a description of the possible benefits of the service, and a statement encouraging decision.
16161150|NCT01694784|Behavioral|Framed Information Sheet|Patients will read an information sheet about one of the three exemplar services in one of four presentations: quantitative, qualitative, narrative, or framed. In the framed information sheet, harms will be communicated using a gain frame (as described in the arm section above) with accompanying fact box. In addition to information about harms, the information sheet will include the following information: a description of the disease to be detected and screening test, a description of the possible benefits of the service, and a statement encouraging decision.
16161151|NCT01694771|Drug|Tiotropium|Marketed dose
16161152|NCT01694771|Drug|Placebo matching Olodaterol|One dose
16161153|NCT01694771|Drug|Olodaterol|One dose
16161154|NCT01694771|Drug|Tiotropium|Marketed dose
16161155|NCT01694732|Drug|Varenicline|
16161156|NCT01694732|Drug|placebo|
16161157|NCT01694719|Behavioral|Brief Behavioral Activation Treatment for Depression|
16161158|NCT01694719|Behavioral|Cognitive Control Training|
16161159|NCT01694706|Drug|faldaprevir|medium dose of faldaprevir
16161160|NCT01694706|Drug|faldaprevir|medium dose of faldaprevir
16161161|NCT01694706|Drug|omeprazole|medium dose of omeprazole
16161162|NCT01694706|Drug|faldaprevir|medium dose of faldaprevir
16161163|NCT01694693|Drug|Orencia|No Intervention
16161164|NCT01694680|Dietary Supplement|Lutein-enriched-egg beverage (NWT-02)|Lutein, zeaxanthin and DHA-enriched-egg yolk combined with buttermilk beverage
16161165|NCT01694680|Dietary Supplement|Placebo|color-, taste- and energy-matched powder without enriched egg-yolk
16161166|NCT01694667|Drug|Omega-3 Fatty Acids|Omega-3 fatty acids will be delivered in orange-flavored pudding packets (Coromega®, Vista, CA). Each packet contains 650 mg of omega-3 fatty acids, 350mg of eicosapentanoic acid (EPA), 230mg of docosahexanoic acid (DHA) and 2,000 mg of fish oil 18/12, and will be given twice daily for a daily dose of 1.3 grams of omega-3 fatty acids (and 1.1 grams of DHA + EPA).
16161167|NCT01694667|Other|Placebo|Placebo packets will have same orange-flavored pudding as active Omega-3 fatty acids comparator with an identical appearance and taste, but will include safflower oil instead of the fish oil. One placebo packet will be given twice daily.
16161168|NCT01694641|Other|time-lapse morphokinetic evaluation|embryo selection for transfer based on a combind score made up of scores for kinetic parameters and standard morphology as seen on time-lapse
16161169|NCT01694628|Behavioral|CLIMB (COPD Lifestyle, Mood, and Behavior)|Cognitive Behavioral Therapy delivered to patients via telephone aimed to improve mood and decrease depressive symptoms.
16161170|NCT01694615|Procedure|Cryoprobe biopsy|
16161171|NCT01694615|Procedure|Forceps Biopsy|
16161172|NCT01694602|Biological|(non-radioactive) Oral deuterated 3-methylhistidine (D-3MH)|Oral dose of 9.0 mg (50 μmol) TAU-METHYL-L-HISTIDINE (METHYL-D3), Cambridge Isotope Laboratory, Cambridge, Massachusetts.
16161173|NCT01694589|Drug|LDE-225|LDE-225 capsules will be administered as a fixed dose of 800 mg daily for two weeks.
16161174|NCT01694576|Drug|Adjuvant chemotherapy with paclitaxel and nedaplatin|Patients receive 3 cycles of adjuvant chemotherapy consisting of paclitaxel and platinum after concurrent chemoradiation
16161175|NCT01694563|Device|Synergy Ablation System|"Patient will undergo an elective open cardiac surgical procedure to be performed on cardiopulmonary bypass for one or more of the following:
~Coronary Artery Bypass Grafting (CABG)
~Mitral valve repair or replacement
~Aortic valve repair or replacement
~Tricuspid valve repair or replacement The aim of the treatment is a complete bi-atrial Maze IV procedure which includes pulmonary vein isolation coupled with lesions made on both the left and right atria."
16161176|NCT01694537|Drug|DLBS1033|The study drug is enteric coated DLBS1033, which contain 490 mg bioactive protein fraction.
16161177|NCT01694537|Drug|placebo|Placebo is made with same size and shape with study drug.
16161178|NCT01694511|Procedure|HRME+CVC|High resolution magnification endoscopy with computed virtual chromoendoscopy and directed biopsy
16161179|NCT01694511|Procedure|conventional endoscopy|Conventional white light endoscopy with four-quadrant biopsy
16161180|NCT01694498|Drug|A: Desmopressin 25 µg|
16161181|NCT01694498|Drug|B. Desmopressin 50 µg|
16161182|NCT01694498|Drug|Placebo|
16161183|NCT01694485|Biological|Abrilumab|Administered by subcutaneous injection.
16161184|NCT01694485|Drug|Placebo|Placebo matching to abrilumab administered by subcutaneous injection
16161234|NCT01694043|Other|Unhealthy Snack Foods|While watching the tv show, participants will receive an unhealthy snack to eat (potato chips and chocolate chip cookies).
16161235|NCT01694030|Other|Attachment security priming|
16161236|NCT01694017|Drug|Tenofovir|tenofovir 300 mg+ emtricitabine 200 mg + efavirenz 600 mg, once daily, for one year
16161673|NCT01690520|Drug|Thiotepa|Given IV
16161185|NCT01694472|Biological|MAGE-A4 TCR Gene-Modified T Cells|The study consists of a 2-dose escalation scheme, and the patient receives twice in each dose. The starting dose is 1-3 x 10^9 cells of each TCR gene-modified cells and the second one is 3-8 x 10^9 cells of each TCR gene-modified cells. Two weeks after the first infusion the patient receives the same dose again, followed by infusions of IL-2 for 5 days. Thereafter, the patient receives peptide vaccinations on days 21 and 28.
16161186|NCT01694459|Drug|Low-dose heparin|Bolus of 50 UI/Kg of heparin at the beginning of coronary interventions
16161187|NCT01694459|Drug|Standard dose heparin|Bolus of 100 UI/Kg of heparin at the beginning of coronary interventional procedure.
16161188|NCT01694446|Other|Intraduodenal glucose or fructose|
16161189|NCT01694433|Drug|Calcipotriene|1g daily BID
16161190|NCT01694433|Drug|Placebo|1g daily BID
16161191|NCT01694420|Drug|(FDC) ELV/COBI/FTC/TDF|Antiretroviral treatment
16161192|NCT01694407|Drug|Tenofovir (TFV) Alone Vaginal Tablet|vaginal tablet containing 40 mg of TFV
16161193|NCT01694407|Drug|Emtricitabine (FTC) Alone Vaginal Tablet|Vaginal Tablet containing 40 mg of TFV
16161194|NCT01694407|Drug|TFV and FTC Combined Vaginal Tablet|vaginal tablet with 40 mg TFV and 40 mg FTC
16161195|NCT01694407|Drug|Placebo Vaginal Tablet|Vaginal Tablet containing no drug
16161196|NCT01694394|Device|Implantable Cardiac Monitor (Confirm ICM model 2102)|Patients who meet the study criteria will be implanted with a St. Jude Medical Confirm Implantable Cardiac Monitor (Confirm ICM) model 2102 or other St. Jude Medical ICM with the same capabilities.
16161197|NCT01694381|Drug|M5|single point mutant of serine protease prourokinase
16161198|NCT01694381|Drug|C1-inhibitor|a protease inhibitor belonging to the serpin superfamily.
16161199|NCT01694355|Drug|Vitamin D|
16161200|NCT01694316|Behavioral|Computerized Neurobehavioral Intervention|Targeted, computerized interventions completed from the participants' own home on a computer.
16161201|NCT01694303|Behavioral|Computerized Neurobehavioral Intervention|Targeted, computerized interventions completed from the participants' own home on a computer.
16161202|NCT01694290|Other|Chemical Cold Pack|
16161203|NCT01694277|Drug|Masitinib|12 mg/kg/day
16161204|NCT01694277|Drug|Sunitinib|50 mg/day
16161205|NCT01694264|Drug|Entecavir|Entecavir (Baraclude (Bristol-Myers Squibb) 0.5mg.) will be taken orally on an empty stomach (2 hours after a meal or at least 2 hours before the next meal), once daily from 1 week before starting anti-TNFα and continue 72 weeks after anti-TNFα is administered.
16161206|NCT01694264|Drug|Placebo|Placebo of Entecavir (prepared by Bristol-Myers Squibb) will be taken orally on an empty stomach (2 hours after a meal or at least 2 hours before the next meal), once daily from 1 week before starting anti-TNFα and continue 72 weeks after anti-TNFα is administered.
16161207|NCT01694238|Procedure|Cruciate incision|
16161208|NCT01694238|Procedure|Circular incision|
16161209|NCT01694238|Other|Mesh enforced cruciate incision|
16161210|NCT01694225|Other|bubble packaging for monthly prescription|Monthly bubble packaging among women prescribed anti-estrogens
16161211|NCT01694212|Drug|Perioperative Diclofenac eye-drops administration|
16161212|NCT01694212|Drug|placebo|
16161213|NCT01694199|Device|Pulsed Radiofrequency Energy (PRFE)|The intervention is pulsed radiofrequencyenergy (PRFE).
16161214|NCT01694199|Device|No Pulsed Radiofrequency Energy (PRFE)|Sham (placebo) with no therapeutic device activity
16161215|NCT01694186|Drug|FAI insert|
16161216|NCT01694186|Drug|Sham injection|
16161217|NCT01694173|Other|Stem cell therapy- SPD artery|A total of 28 patients will be enrolled and randomized to four groups of 7 patients each. 7 patients will receive stem cell infusion into the superior pancreaticoduodenal artery. Another 7 patients will be given stem cell infusion into the splenic artery. The next batch of 7 patients will receive stem cell infusion from the peripheral intravenous route and 7 patients will act as controls undergoing a sham procedure with infusion of normal saline.
16161218|NCT01694173|Other|Stem cell therapy- splenic artery|7 patients will receive stem cells infusion through splenic artery.
16161219|NCT01694173|Other|Stem cell therapy-intravenous|7 patients will receive stem cells infusion through peripheral intravenous route.
16161220|NCT01694173|Other|Normal saline placebo -sham procedure|7 patients will receive infusion of normal saline and will act as control groups
16161221|NCT01694160|Drug|Paricalcitol|Zemplar (paricalcitol) 2ug daily, oral intake
16161222|NCT01694147|Device|PiCCO monitoring system|The EVLW measurement will be based on transpulmonary thermodilution method. This method was recently introduced as part of the PiCCO plus system (Pulsion Medical System, Munich, Germany), for monitoring severe sepsis patients being treated in medical ICUs. This method only used a single indicator (cold saline solution), and demonstrated a satisfactory correlation with the gravimetric method. A 4-F arterial catheter (PulsiocathPV2014L16; Pulsion Medical Systems, Munich, Germany) was positioned in the descending aorta via the femoral artery using the Seldinger technique. The femoral arterial catheter and a standard central venous catheter were connected to pressure transducers, and also to an integrated bedside monitor (PiCCO; Pulsion Medical Systems).
16161223|NCT01694134|Drug|Hydrocortancyl.|Patients will receive an intradiscal injection of hydrocortancyl.
16161224|NCT01694134|Drug|Lidocaine|
16161225|NCT01694121|Behavioral|MEN Count|The MEN Count model integrates HIV risk reduction and gender-equity counseling with housing and employment case management via multiple one-on-one sessions delivered by a peer case manager over 60-90 day period.
16161226|NCT01694121|Behavioral|Comparison|general health intervention for men, not inclusive of HIV or relationship health
16161227|NCT01694108|Biological|BCG-vaccine (SSI)|
16161228|NCT01694082|Behavioral|THRIVE|THRIVE stands for (Tertiary Health Research Intervention Via Email). Participants complete questions related to demographics and their alcohol use and receive brief personalized feedback based on this information, in addition to protective behavioral strategies, facts about alcohol and information about available resources to reduce their alcohol use.
16161229|NCT01694082|Behavioral|Brief brochure and assessment control|
16161230|NCT01694069|Drug|Piperacillin-tazobactam combination product|400 mg/kg/day as either intermittent or continuous infusion
16161231|NCT01694056|Other|Soy protein diet|4 weeks high protein diet (20 en%) with 25gr of soy protein per day
16161232|NCT01694056|Other|Control diet|4 weeks high mixed protein diet (20 en%)
16161237|NCT01694017|Drug|Zidovudine|zidovudine 300 mg + lamivudine 150 mg + nevirapine 200 mg , once daily, for a year
16161238|NCT01694004|Drug|Benzocaine Infusion into Duodenum|
16161239|NCT01693991|Behavioral|Meaning-Making intervention (MMi)|MMi and attention control sessions will take place weekly for 3 weeks at the patient's home or hospital, as the patient prefers. We will try to limit delays to no more than 1 week if needed (e.g., for recovery from treatment side-effects), but because the feasibility of this schedule is one of the research questions, if more flexibility is required we will not withdraw people from the study if the delay is longer, since a longer intervention period could be incorporated in a full-scale RCT. Dates and duration of each session will be tracked. MMi sessions will be conducted by 2 bilingual mental health professionals (nurse, social worker, or psychologist) with at least 1 year of clinical oncology experience and will be initiated within 1 week after randomization.
16161240|NCT01693991|Behavioral|Empathic visitor|This person will provide the basic ingredients fostering a good therapeutic relationship (i.e., trust, warmth, empathy, neutrality and authenticity) without further intervention or probing. The empathic visitor will be specifically instructed to avoid initiating discussions about meaning (e.g., how the patient interprets his feelings and thoughts, understands his/her illness and meaning in life), and focus discussions on what is currently happening (rather than on the interface between past and present).
16161241|NCT01693978|Behavioral|Prolonged Exposure Therapy|"Prolonged Exposure Therapy is considered the gold standard treatment for PTSD in psychiatry. It uses a cognitive-behavioral approach that repeatedly and systematically exposes patients to memories of their traumatic events to reduce fear and arousal. The PE therapy offered in this study will be based on procedures used by Foa and colleagues, described in their book-length treatment manual (Foa, Hembree, & Rothbaum, 2007)."
16161242|NCT01693978|Behavioral|Voucher-Based Reinforcement|Those in the PE+CM condition will also be able to earn voucher-based incentives for each therapy session that they attend as scheduled, with a maximum of $480 for full adherence to all sessions. Specifically, participants will earn $30 for attending Session 1, $40 for attending Session 2, $50 for attending Session 3, and $60 for attending Sessions 4 through 9. There will be no payment for Sessions 10 through 12. Because it is very important that participants attend sessions on schedule, voucher values will be reset starting from $30 if participants miss a scheduled session. Vouchers can be exchanged for goods and services in the community (e.g., gift cards to local retailers).
16161243|NCT01693965|Other|sputum samples|
16161244|NCT01693952|Biological|blood draw|
16161245|NCT01693939|Device|FS200 Femtosecond Laser|
16161246|NCT01693926|Behavioral|Acute physical activity intervention|25 min of physical activity. The placebo arm will have 25 min of reading.
16161247|NCT01693926|Behavioral|placebo|
16161248|NCT01693913|Behavioral|cognitive behavioral exercise and nutrition over|
16161249|NCT01693913|Behavioral|nutrition and exercise education|
16161250|NCT01693900|Procedure|Pre-operative Ultrasound FICB Group|Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed under ultrasound guidance with an in-plane technique by a single study investigator in the preoperative area. Although possible without ultrasound guidance, using this technique allows for identification of specific tissue planes and precise placement of medication near the nerves responsible for postoperative pain. Using ultrasound, the superficial fascial layer of the iliopsoas muscle is identified at the anterior edge of the ilium, and a needle is placed just beneath that fascia. A high volume of local anesthetic is then injected under ultrasound guidance, ensuring cephalad spread of medication in an attempt to provide anesthesia of the lateral femoral cutaneous, femoral and obturator nerves.
16161251|NCT01693900|Procedure|Intra-operative FICB Group|Enrolled subjects will receive FICB with 50cc of 0.3% ropivacaine. Blocks will be performed intra-operatively under direct surgeon visualization, in the operating room. Unlike other approaches to hip replacement, anterior repair allows for direct visualization of the fascial layers described above. This allows for direct injection of local anesthetic beneath this fascia, potentially obviating the need for preoperatively performed, ultrasound guided, FICB.
16161252|NCT01693874|Behavioral|MBSR|Mindfulness-Based Stress Reduction
16161253|NCT01693874|Behavioral|control (health education)|health education
16161254|NCT01693822|Drug|Axitinib|"Axitinib treatment Axitinib is an oral VEGF-receptor inhibitor. Patients are prescribed a starting dose of 5mg twice daily, escalating to 10mg in absence of dose limiting toxicities.
~Patients should stop axitinib treatment one week prior to day 1 week 9 percutaneous research biopsy of the primary renal tumour and restart 2-3 days post biopsy.
~Doses should be taken approximately 12 hours apart and patients should be instructed to take their doses at approximately the same times each day.
~Dose adjustments, including dose increase or dose reduction, are permitted and should be based on clinical judgement and the guidelines provided in the protocol."
16161255|NCT01693809|Drug|Caffeine|
16161256|NCT01693796|Other|blood and urine samples ; Echography|
16161257|NCT01693783|Biological|Ipilimumab|Given IV
16161258|NCT01693783|Other|Laboratory Biomarker Analysis|Correlative studies
16161259|NCT01693770|Procedure|MRgFUS|Focused ultrasound energy is accumulated into the target tissue (skeletal metastasis) thanks to the real time guidance of the MR images.
16161260|NCT01693718|Drug|Hydroxyurea|Hydroxyurea at 1gm(PO)12hrs x 11days(2gm/day). The first daily dose of hydroxyurea on days 1-5 is given 2 hrs prior to the first fraction of daily radiotherapy.
16161261|NCT01693718|Drug|5- Fluorouracil|"Start continuous infusion of 5-Fluorouracil at 800mg/m2/day x 5 days (120 hrs.
~Radiation therapy is administered twice daily at 150 cGY per fraction, every other week with chemotherapy."
16161262|NCT01693718|Drug|Cisplatin|Cisplatin 100mg/m2 I.V. on the evening of the day 1, on cycles 1,3,and 5 only in 200cc NS IV over 2 h. Ensure adequate hydration to keep urine output > 100 cc/ hour.
16161263|NCT01693705|Procedure|Tracheostomy|
16161264|NCT01693692|Drug|TD-9855 Group 1|
16161265|NCT01693692|Drug|TD-9855 Group 2|
16161266|NCT01693692|Drug|Placebo|
16161267|NCT01693679|Drug|Telbivudine, Lamivudine, Adefovir ,Enecavir|investigational Telbivudine,600mg,daily,oral.comparator Lamivudine,100mg daily, oral,Adefovir,10mg,daily,oral,Enecavir,0.5mg,daily,oral.
16161293|NCT01693419|Drug|GES (Gemcitabine, Erlotinib, S-1)|"Treatment will be delivered as a 3-week cycle.
~Gemcitabine 1000 mg/m² IV on day 1, 8
~Erlotinib 100 mg/day PO on day 1
~S-1 60 mg/m²/day PO on day 1-14"
16161294|NCT01693393|Drug|Cyclosporine A|Patients will receive Cyclosporine A in a dose of ca. 2mg/kg/BW daily for a 16 week period
16161268|NCT01693666|Behavioral|Lifestyle intervention|"To establish an effective contingency management behavioral program (LIFE), increasing adherence to nutritional recommendations and exercise guidelines during pregnancy.
~To examine the impact of the LIFE program on weight gain restriction during pregnancy and postpartum weight loss in obese women in comparison to the RC group.
~To examine the impact of the LIFE program on short- and long-term maternal and offspring outcomes at study enrollment, 34-36 weeks gestation and 3 months postpartum in obese women in comparison to the RC group."
16161269|NCT01693653|Drug|Tocilizumab|Intravenous infusions every 4 weeks for 3 doses.
16161270|NCT01693640|Drug|Abatacept|Weekly injections with Abatacept 125 mg over 6 months
16161271|NCT01693627|Device|Pinnacle/Corail with collar|Uncemented THA using Pinnacle-100/Marathon XLPE(Depuy, Warsaw, IN) acetabular component and Corail(Depuy,Warsaw,IN)collared femoral stem with 32mm Alumina Biolox Forte(Depuy,Warsaw,IN). Tantalum beads will be inserted into periprosthetic bone.
16161272|NCT01693627|Device|Marathon/Corail with collar|Reversed hybrid THA using cemented Marathon XLPE(Depuy,Warsaw,IN) acetabular component and an uncemented Corail(Depuy,Warsaw,IN)collared femoral component with 32 mm Alumina Biolox Forte(Depuy,Warsaw,IN)head. Tantalum beads will be inserted into periprosthetic bone.
16161273|NCT01693627|Device|Pinnacle/Corail without collar|Uncemented THA using Pinnacle-100/Marathon XLPE(Depuy, Warsaw, IN) acetabular component and Corail(Depuy,Warsaw,IN)collarless femoral stem with 32mm Alumina Biolox Forte(Depuy,Warsaw,IN). Tantalum beads will be inserted into periprosthetic bone.
16161274|NCT01693627|Device|Marathon/Corail without collar|Reversed hybrid total hip arthroplasty using cemented Marathon XLPE(Depuy,Warsaw,IN) acetabular component and an uncemented Corail(Depuy,Warsaw,IN)collarless femoral component with 32 mm Alumina Biolox Forte(Depuy,Warsaw,IN)head. Tantalum beads will be inserted into periprosthetic bone.
16161275|NCT01693614|Drug|Buparlisib|100 mg hard gelatin capsules administered orally, once daily in cycles of 28 days
16161276|NCT01693601|Drug|Panobinostat|PO TIW QOW or PO TIW QW
16161277|NCT01693601|Drug|Ruxolitinib|PO BID x 28 days
16161278|NCT01693588|Other|Pain Management Bundle|The Pain Management Bundle will be implemented for all postoperative neurosurgical patients admitted to nursing units at the University of Florida.
16161279|NCT01693575|Device|Pupil expansion with APX 100 device|Patients with small pupils (<4.5 mm) that would not dilate pharmacologically or small pupils that develop intraoperatively due to intraoperative floppy iris syndrome (IFIS) will be assigned to APX 100 device intervention during standard phacoemulsification cataract surgery. After creating two standard clear corneal incisions in the horizontal meridians, two APX 100 retractors will be inserted to the anterior chamber of the eye 180 degrees apart with special forceps, one retractor at a time, and will be located on the pupil's border between the iris and the anterior lens capsule. Then, the devices will be released from the forceps and the pupil diameter will expand. The next steps of the surgery will remain unchanged. After the implantation of the intraocular lens (IOL) in the capsular bag the APX 100 retractors will be removed the same way as inserted. The clear corneal incisions will then be closed by hydration.
16161280|NCT01693562|Drug|MEDI4736|Participants will receive IV infusion of MEDI4736 for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.
16161281|NCT01693549|Drug|Cabazitaxel|
16161282|NCT01693536|Behavioral|Lifestyle counselling|as in Arm Description
16161283|NCT01693523|Drug|Minocycline|100 mg by mouth two times a day (200 mg/day).
16161284|NCT01693523|Other|Placebo|Matching placebo capsules by mouth twice a day.
16161285|NCT01693523|Behavioral|Questionnaires|Questionnaires completed at baseline, 1 time each week during drug/placebo administration, and at end of study visit.
16161286|NCT01693510|Behavioral|Exercise and Nutrition Intervention|Both Intervention and Control participants and their care providers receive the new Health Canada guide on Healthy Weight Gain During Pregnancy. For the Experimental Group, the exercise intervention includes a custom-designed pregnancy-specific group walking class of 30-60 min. 1x/week and a prescribed at-home walking program to reach 10,000 steps/day. The nutrition intervention is a high protein (25% energy) low-fat dairy food plan designed to meet energy needs and with individualized counselling.
16161287|NCT01693497|Behavioral|Dialogical exposure therapy|This 24-session treatment protocol includes cognitive-behavioral components integrated with a frame based on gestalt principles. There are four phases, safety, stabilization, confrontation and integration.
16161288|NCT01693497|Behavioral|Cognitive Processing Therapy (German Adaptation)|This is a German adaptation of Cognitive Processing Therapy, developed by Prof. P. A. Resick. This intervention includes cognitive restructuring, a focus on the traumatic memory and a focus on issues that are likely to be problematic in traumatized individuals.
16161289|NCT01693484|Drug|ICG (Indocyanine Green)|Diagnostic drug used for visualisation of blood perfusion in various tissues.Administered intravenously, 2X: 1X prior to anesthesia, and 1X after tourniquet on operative extremity has been released for at least 15 minutes. When excited by laser light source, it subsequently emits at a near infrared frequency.
16161290|NCT01693458|Behavioral|Appreciative Inquiry Change Agents (CA) program (NAMWEZA)|The intervention is based on an Appreciative Inquiry approach that comprises a 10-session program based on learning by doing rather than factual classroom type learning, although it includes discussion of relevant facts about HIV, and other STIs. The intervention is based on the template of Stepping Stones (Jewkes et al., 2008), which is internationally one of the most widely used participatory behavioral interventions targeting sexual health. The Stepping Stones curriculum was shortened and radically adapted from more than 20 sessions. However NAMWEZA borrows generously from many of the exercises and games. It also employs the successful experience of stratification by age and sex to engage 4 different working groups (younger and older, male and female).
16161291|NCT01693445|Drug|OIS (Oxaliplatin, Irinotecan, S-1)|"Dose level 1 treatment will be delivered as a 2-week cycle as bellows;
~Oxaliplatin 85 mg/m²IV on day 1
~Irinotecan 120 mg/m² IV on day 1
~S-1 60 mg/m2/day PO on day 1-7
~Dose escalation will be continued until more than one-third of the patients in a given cohort show dose limiting toxicities (DLT) during treatment cycle 1. If at least 2 patients are observed to have DLT, this dose level is defined as the maximum tolerated dose (MTD). If exactly 1 of the 3 patients treated show DLT, 3 additional patients are treated at the current dose level."
16161292|NCT01693432|Drug|DS (docetaxel+S-1)|"Treatment will be delivered as a 3-week cycle.
~Docetaxel 60 mg/m²IV on day 1
~S-1 80 mg/m2/day PO on day 1-14"
16161295|NCT01693380|Biological|Influenza vaccine|"Influenza vaccine: schoolchidren in the experimental group received IM administered:
~From 6 to 9 years of age - 2 doses (0.5ml each) of the tri-valent innactivated influenza vaccine - Southern Hemisphere formulation, 2009 - one month apart.
~9 years of age and older: one dose (0.5ml) of the tri-valent innactivated influenza vaccine - Southern Hemisphere formulation, 2009 - one month apart."
16161296|NCT01693380|Biological|Control vaccine|"Schoolchildren from 6 to 8 years of age:
~- One dose (0.5ml), IM administered, of Meningococcal C conjugate vaccine, and one dose (0.5ml), one month later, of varicella vaccine, IM administered."
16161297|NCT01693367|Device|DLS 5.0 (Dynamic locking screws)|Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP) and DLS 5.0
16161298|NCT01693367|Device|SLS (Standard locking screw)|Open reduction and internal fixation (ORIF) of the distal femur with a large fragment locking plate (LISS, LCP)and SLS (Standard locking screw)
16161299|NCT01693354|Device|Mid-dilution HDF|Mid-dilution HDF is a special, newly developed variant of online HDF which is characterized by a dedicated high-flux hemodialyzer named OLPUR MD able to support simultaneous pre- and post-dilution
16161300|NCT01693354|Device|HF dialysis|Standard hemodialyzers equipped with high permeability polyphenylene/polyethersulfone membranes
16161301|NCT01693341|Other|Care-giver mediated training|A physical therapist visited each subject and the caregiver (of the intervention group) once weekly for about 90 min/session to teach patient-skills and caregiver-skills. The therapist first reviewed the condition of each patient and planned patient-specific training programs, continuously performed 12 weeks.
16161302|NCT01693328|Drug|PecFent® (fentanyl) nasal spray|
16161303|NCT01693315|Drug|AMA0076|
16161304|NCT01693315|Drug|Placebo|
16161305|NCT01693302|Other|Insulin|The timing of insulin delivery varies with each study visit. The dose is given based on carbohydrate content and blood glucose level. The insulin is given either 20 minutes before the meal, immediately before the meal, or 20 minutes after the meal.
16161306|NCT01693289|Drug|metformin plus letrozole|
16161307|NCT01693289|Procedure|ovarian drilling|
16161308|NCT01693276|Drug|Gemcitabine|"gemcitabine 1000mg/m2 given on day 1,8, and 15 of a 28 day cycle for 2 cycles prior to chemoradiation and post RT.
~Gemcitabine 450 mg/m2, 30-minute infusion, given weekly during chemoradiation for a total of 6 weeks."
16161309|NCT01693276|Drug|Abraxane|Abraxane® 100 mg/m2 given on day 1,8, and 15 of 28 day cycle for 2 cycles prior to RT and each cycle post RT
16161310|NCT01693276|Radiation|Radiation Therapy|IMRT Dose escalation: 60 Gy (2 Gy/fraction)
16161311|NCT01693263|Other|brachiocephalic fistula (BCF)|We will collect information from physical exams, blood tests, venogram, doppler, vein and artery tissue samples
16161312|NCT01693250|Behavioral|fitbit Ultra|Participants will be asked to wear the Fitbit device and use the app every day for three months. The app functions will include tracking of PA and dietary intake progress, setting individualized and realistic goals, monitoring progress related to reaching the goals, providing tips of everyday activities, and having interactive games related to PA and healthy diet.
16161313|NCT01693250|Behavioral|Pedometer|adolescents in the control group will be given an Omron HJ-105 pedometer and a food diary and be asked to use them for three months.
16161314|NCT01693237|Other|Group psychotherapy|20 sessions of systemic and narrative group therapy
16161315|NCT01693237|Other|Group psychotherapy with feedback|20 sessions of systemic and narrative group therapy
16161316|NCT01693224|Device|"Alere Determine lateral-flow urine lipoarabinomannan assay"|"lateral-flow (point-of-care) urine test to detect the lipoarabinomannan (LAM) component of the M. tuberculosis antigen in the urine of TB suspects, in vitro.
~Manufacturer: Alere"
16161317|NCT01693224|Device|"Alere Clearview ELISA urine LAM assay"|"ELISA-based urine test to detect the lipoarabinomannan component of the M. tuberculosis antigen in the urine of TB suspects, in vitro.
~Manufacturer: Alere."
16161318|NCT01693224|Device|Cepheid Xpert MTB/Rif assay|
16161319|NCT01693211|Device|Femtosecond Laser (VICTUS™ Femtosecond Laser Platform)|Capsulotomy and pre-fragmentation of the nucleus are performed by the femtosecond laser.
16161320|NCT01693211|Device|Manual (CCC technique with Utrata forceps)|Capsulorhexis and pre-fragmentation are performed manually.
16161321|NCT01693198|Procedure|Skin test with sterile extracts of different cyanobacteria|Skin test with sterile extracts of different cyanobacteria is performed on the volar aspect of the forearm. Typically, the results are read 15 minutes after performing the test. Test is regarded as positive when wheal of more than 3mm and flare appear within this time frame. Positive test indicates the existence of specific IgE to the extract in on skin mast cells .
16161322|NCT01693185|Drug|Remifentanil|continuous infusion 0.4 mcg/kg/min
16161323|NCT01693185|Drug|Midazolam|bolus injection
16161324|NCT01693185|Drug|Meperidine|bolus injection for 30 sec 1.0 mg/kg
16161325|NCT01693185|Drug|placebo (for remifentanil)|normal saline mimic diluted remifentanil
16161326|NCT01693185|Drug|placebo (for midazolam)|normal saline mimic to midazolam injection
16161327|NCT01693185|Drug|placebo (for meperidine)|normal saline mimic meperidine injection
16161328|NCT01693172|Behavioral|Early mobilization program|Early postoperative supervised aerobic exercise, resistance and flexibility training
16161329|NCT01693159|Device|ECA|In the experimental arm patients will be topically treated with the liquid glue ethyl-2-cyanoacrylate (ECA).
16161330|NCT01693159|Other|Standard topical treatment of the institution, e.g. Lotio|Standard treatment of the institution to treat painful cetuximab-induced rhagades
16161331|NCT01693146|Device|Nasal oxygen insufflation with a TNI® 20 oxy device|Nasal insufflation at a constant high flow of 15 L/min with oxygen addition starting at 0.5 L/min
16161332|NCT01693146|Device|Nasal insufflation of oxygen|Nasal insufflation of oxygen starting at at flow of 0.5 L/min.
16161333|NCT01693133|Other|Standard of Care: Moist Wound Therapy and Offloading|Standard of Care: Moist Wound Therapy and Offloading
16161334|NCT01693133|Other|EpiFix plus Standard of Care|Weekly application of EpiFix and Standard of Care
16161335|NCT01693120|Device|Medtronic Phased RF Ablation System|Phased RF ablation
16161427|NCT01692301|Drug|hydrochlorothiazide|hydrochlorothiazide 6.25mg, 12.5mg, or 25 mg tablets
16161461|NCT01692015|Procedure|Blood tests for full blood count, albumin, and indices of nutritional status|
16161462|NCT01692002|Dietary Supplement|Sodium propionate|Sodium propionate capsule or tablet
16161336|NCT01693094|Behavioral|Decision Aid|"Cohort I will be managed with a decision aid (henceforth DA), and Cohort II will be managed without one. The patients in Cohort I will receive the DA, which they can complete in a separate room and take home. The decision aids include information on the disease/condition, treatment options, benefits, risks, scientific uncertainties, and probabilities of potential outcomes tailored to the patient's health risks factors. Additionally, it includes values clarifications such as describing outcomes in functional terms, asking patients to consider which benefits and risks matter most to them, and guidance in the steps of decision making and discussing their decision with family/friends. It is interactive and dynamic, helping patients clarify their preferences and come to a decision that feels best to them."
16161337|NCT01693081|Drug|VR040/Aspirair® inhaler|Dry Powder inhaled apomorphine
16161338|NCT01693081|Drug|placebo|
16161339|NCT01693068|Drug|Pimasertib|Subjects will receive pimasertib orally as monotherapy at a dose of 60 milligram (mg) twice daily continuously. Treatment will consist of repeated 21-day cycles which will continue until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurs first.
16161340|NCT01693068|Drug|Dacarbazine|Subjects will receive dacarbazine intravenously at dose of 1000 milligram per square meter (mg/m^2) of body surface area every 3 weeks on Day 1 of each 21-days cycle until progression of the disease, unacceptable toxicity, withdrawal of informed consent, or death, whichever occurs first. Eligible subjects with documented tumor progression on dacarbazine will offer to switch to pimasertib treatment.
16161341|NCT01693055|Device|UltheraTM 100 shots|UltheraTM 100 shots (infraorbital region 30shots, lateral orbital region 40shots, upper eyelid 30 shots) on the Rt, and Lt periorbital area, respectively using 1.5mm and 3.0mm probe
16161342|NCT01693042|Biological|intracoronary infusion of autologous bone marrow-derived cells|Intracoronary infusion into open vessel / bypass supplying previous (> 3 months) infarct area
16161343|NCT01693029|Drug|HX575 epoetin alfa|Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL.
16161344|NCT01693029|Drug|US-licensed epoetin alfa|Solution for subcutaneous injection.
16161345|NCT01693016|Device|non-invasive measurement of Hb|
16161346|NCT01693016|Procedure|taking blood samples|
16161347|NCT01693003|Drug|Indacaterol|150 µg d.o. during the first 3 weeks
16161348|NCT01693003|Drug|Tiotropium|150 µg d.o. during 3 weeks
16161349|NCT01692990|Dietary Supplement|Fish oil|For 3 weeks 5 g/d in 10 capsules, providing 3.5 g long-chain n-3 fatty acids in the fish oil period. Cross-over between arms with 1 week of wash out
16161350|NCT01692977|Other|neuropsychological assessment|
16161351|NCT01692964|Device|InflammaDry|A noninvasive immunoassay for detecting MMP-9 levels in tears.
16161352|NCT01692951|Other|serum sample|Serum samples from lung cancer patients were collected at the time of their diagnosis, prior to the initiation of treatment. Serum samples of control subjects were collected from a biobank
16161353|NCT01692925|Drug|turoctocog alfa|Trial product, 2000 IU/vial will be administered as an i.v. (intravenous) bolus injection.
16161354|NCT01692925|Drug|turoctocog alfa|Trial product, 3000 IU/vial will be administered as an i.v. (intravenous) bolus injection.
16161355|NCT01692912|Other|Intensive Care|Rheumatologist aims to treat participant in order to achieve a disease activity score improvement of DAS28<2.6
16161356|NCT01692886|Biological|7-valent Pneumococcal Conjugate Vaccine|suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively
16161357|NCT01692886|Biological|13-valent Pnumococcal Conjugate vaccine|suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 4-Month Visit, 5-Month Visit, and 12-Month Visit, respectively
16161358|NCT01692886|Biological|13-valent Pnumococcal Conjugate vaccine|suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 2-Month Visit, 4-Month Visit, 6-Month Visit, and 12-Month Visit, respectively
16161359|NCT01692886|Biological|13-valent Pnumococcal Conjugate vaccine|suspension in prefilled syringe for intramuscular injection; 0.5 mL; one dose at 3-Month Visit, 5-Month Visit, and 12-Month Visit, respectively
16161360|NCT01692873|Procedure|suspected pancreatic tumor|Realization of pancreatic surgery to obtain tumor biopsy and blood samples to realize biomarkers analyses.
16161361|NCT01692860|Other|Energy Restriction|Subjects consume 750 kcal/d of energy below their need
16161362|NCT01692834|Drug|Sandimmune® Injection|
16161363|NCT01692834|Drug|NeuroSTAT®|
16161364|NCT01692821|Drug|100% oxygen breathing|100% oxygen breathing - 30 minutes
16161365|NCT01692821|Drug|15% oxygen in N2 breathing|15% oxygen in N2 breathing - 30 minutes
16161366|NCT01692821|Drug|12% oxygen in N2 breathing|12% oxygen in N2 breathing - 30 minutes
16161367|NCT01692808|Drug|Vitamin D3 3000 UI daily|Vitamin D3 will be administered as an adjunct to corticosteroids or enteral nutrition at the doses of 3000 UI daily or 4000 UI daily
16161368|NCT01692808|Drug|Vitamin D3 4000 UI daily|This arm is intended for those at diagnosis treated with Corticosteroid or in Remission
16161369|NCT01692782|Drug|SEP-225289|SEP-225289 4mg once daily
16161370|NCT01692782|Drug|SEP-225289|SEP-225289 8mg once daily
16161371|NCT01692782|Drug|Placebo|Placebo once daily
16161372|NCT01692769|Drug|Normal Saline|Patients randomized to Normal Saline arm, will receive intravenous normal saline for all resuscitation and maintenance fluid for a period of 24 hours commencing on presentation to hospital.
16161373|NCT01692769|Drug|Ringer's Lactate|Patients randomized to Ringer's Lactate arm, will receive intravenous Ringer's Lactate for all resuscitation and maintenance fluid for a period of 24 hours commencing on presentation to hospital.
16161374|NCT01692756|Drug|Kenalog or placebo|
16161375|NCT01692756|Drug|Kenalog then Placebo|
16161376|NCT01692756|Drug|Kenalog|
16161377|NCT01692756|Drug|Placebo|
16161378|NCT01692743|Behavioral|Home Monitoring|Participants log onto the TELE-IBD website weekly to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.
16161456|NCT01692041|Drug|ivy leaves dry extract|5 ml twice daily po
16161457|NCT01692041|Drug|Placebo|5 ml per os twice daily
16161379|NCT01692743|Behavioral|Home Monitoring|Participants log onto the TELE-IBD website every other week to answer questions about disease symptoms, adherence, side effects, to check body weight and to receive educational content. Participants receive self action plans after each self-testing session. Alerts are generated to the nurse coordinator if certain clinical criteria are met.
16161380|NCT01692730|Behavioral|Enhanced Web Assisted Tobacco Intervention|Subjects at community college campuses will be directed to a cessation website with current Public Health Service Guideline information and effective smoking cessation strategies, and some combination of novel interactive and social network features, including a variety of better-practice features recommended recent literature, and technologically advanced proactive features (e-mails, SMS texting, and social networking).
16161381|NCT01692730|Behavioral|Basic Web Assisted Tobacco Intervention|Subjects at community college campuses will be directed to a cessation website with current Public Health Service Guideline information and effective smoking cessation strategies, and with minimal interactive web-based features.
16161382|NCT01692717|Drug|Atorvastatin|10 mg
16161383|NCT01692717|Drug|Hydrochlorothiazide + Losartan|12.5 mg + 50 mg
16161384|NCT01692717|Drug|Hydrochlorothiazide + Losartan + Atorvastatin|12.5 mg + 50 mg + 10 mg
16161385|NCT01692704|Drug|Selective intra-arterial floxuridine and systemic gemcitabine and cisplatin|"Intra-arterial floxuridine:0.2 mg/KG/day for 14 days, repeated day 29. Overall 3 applications.
~Systemic cisplatin: 25 mg/m2 at days 1 and 8, repeated day 22. Overall 8 applications.
~Systemic gemcitabine: Three different dose levels will be tested; 600 mg/m2, 800 mg/m2, or 1000 mg/m2, at days 1 and 8, repeated day 22. Overall 8 applications."
16161386|NCT01692691|Drug|Dacarbazine|Dacarbazine IV - Day 1
16161387|NCT01692691|Drug|Carmustine|Carmustine IV- Day 2
16161388|NCT01692691|Drug|Neulasta|Neulasta SC - Day 3
16161389|NCT01692678|Drug|Trabectedin|Type=exact number, unit=mg/m2, number=1.5, 1.2 or 1.0, form=solution, route=intravenous infusion. Trabectedin will be administered on Day 1 of each 21-day treatment cycle.
16161390|NCT01692678|Drug|Dacarbazine|Type=exact number, unit=g/m2, number=1, form=solution, route=intravenous infusion. Dacarbazine will be administered on Day 1 of each 21-day treatment cycle.
16161391|NCT01692652|Drug|topical loteprednol etabonate (lotemax 0.5%) with warm compress & ocular massage|
16161392|NCT01692652|Other|warm compress only group|
16161393|NCT01692626|Drug|Pimecrolimus|Pimecrolimus 1% topical cream applied twice daily for four weeks on one side of the face.
16161394|NCT01692626|Drug|Placebo|Placebo cream applied twice daily for four weeks on opposite side of the face from the Pimecrolimus side.
16161395|NCT01692587|Other|Protein restrictive diet|To begin a reduced protein diet
16161396|NCT01692574|Behavioral|Behavior Modification for Weight Loss|
16161397|NCT01692574|Behavioral|Alternative Approach to Weight Loss|
16161398|NCT01692574|Behavioral|Cognitive-Behavior Therapy for Depression|
16161399|NCT01692574|Behavioral|Depression Support and Education|
16161400|NCT01692548|Other|Neurofeedback|
16161401|NCT01692535|Procedure|Intubation|Intubation with one of the six videolaryngoscopes
16161402|NCT01692522|Procedure|Intubation|visualized blind intubation
16161403|NCT01692496|Drug|Pazopanib|Patients will receive oral pazopanib, 800mg once daily and treatment will continue until disease progression, development of unacceptable toxicity, noncompliance, withdrawal of consent by the patient or investigator decision.
16161404|NCT01692483|Drug|Abiraterone acetate|Abiraterone 1000 mg (4 x 250 mg tablets) taken orally once daily
16161405|NCT01692483|Drug|Prednisone|Prednisone or prednisolone 5 mg tablet taken orally twice daily
16161406|NCT01692470|Drug|No intervention|Patients will be taking rilpivirine hydrochloride as per the dosing regimen given on product insert approved in Philippines (ie, 1 tablet of 25 mg orally once a day) in combination with anti-retroviral (ARV) medications.
16161407|NCT01692457|Drug|No intervention|This is an observational study. Golimumab will be administered as per the recommended doses. Golimumab 50 mg will be given as a subcutaneous injection once a month, on the same date each month. For rheumatoid arthritis: Golimumab 2 mg/kg will be given as a 30 minute intravenous infusion at Weeks 0 and 4, then every 8 weeks thereafter.
16161408|NCT01692431|Dietary Supplement|EPA|High fat meal containing EPA
16161409|NCT01692431|Dietary Supplement|DHA|High fat meal containing DHA
16161410|NCT01692431|Dietary Supplement|Placebo|High fat meal containing negligible EPA/DHA content
16161411|NCT01692418|Drug|Ferric carboxymaltose|1000mg of ferric carboxymaltose will be administered as an i.v. infusion (100ml normal saline)
16161412|NCT01692418|Drug|Normal saline|Normal saline will be administered as an i.v. infusion (100ml normal saline)
16161413|NCT01692405|Device|NaviGo Bx™|The NaviGoBx™ system is a device and method that enables an accurate reporting of the exact longitudinal location and direction of the biopsy specimen along the needle notch as well as the accurate length of the specimen. Acquiring this information during the biopsy extraction session provides an accurate designation of the location of any later region of interest within the specimen itself to the longitudinal position along the needle mandrel.
16161414|NCT01692405|Procedure|biopsy sponge pad|the biopsy core is downloaded onto a biopsy sponge pad which is than entered into a biopsy cassette.
16161415|NCT01692379|Device|Solitaire FR device|Mechanical embolectomy in anterior large vessel occlusion
16161416|NCT01692379|Other|Medical treatment|Standard of care in acute ischemic stroke including intravenous rTPA
16161417|NCT01692366|Drug|SAR302503|"Pharmaceutical form:Capsule
~Route of administration: oral"
16161418|NCT01692353|Other|Subject's usual brand (UB) tobacco product|For SMK: UB of cigarettes; For MSC: UB of moist snuff
16161419|NCT01692340|Other|Isotopically labeled lycopene, phytoene or phytofluene|We will administer 10 mg of labeled carotenoid mixed with olive oil and spread on an English muffin for consumption by participants.
16161420|NCT01692327|Dietary Supplement|High fat meal|
16161421|NCT01692314|Other|Resistance training|
16161422|NCT01692301|Drug|LCZ696|200 mg tablet
16161423|NCT01692301|Drug|Olmesartan|20 mg and 40 mg capsules
16161424|NCT01692301|Drug|LCZ696 matching placebo|LCZ696 Matching Placebo tablet
16161425|NCT01692301|Drug|Olmesartan matching placebo|Olmesartan matching placebo capsule
16161426|NCT01692301|Drug|amlodipine|amlodipine 2.5 mg or 5 mg tablets
16161428|NCT01692288|Behavioral|First Born® Program home visiting services|Family and first-born child are offered and/or receive weekly First Born® Program home visiting services between pregnancy and the child's third birthday. Families are eligible to enroll in the program from pregnancy up to two months after birth.
16161429|NCT01692275|Other|Medical Care + Chiropractic Care|Patients will receive chiropractic spinal manipulative therapy plus conventional medical care. Medical may include the following: education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.
16161430|NCT01692275|Other|Conventional Medical Care Only|Conventional medical care may include the following: a focused history and physical examination; limited diagnostic imaging restricted to select volunteers (i.e., for example, those with radiculopathy); education about self-management, including maintaining activity levels as tolerated and local ice/heat application; pharmacologic management with the use of analgesics and anti-inflammatory agents; and additional therapies that may be applied for volunteers not responding to the initial interventions, including physical therapy and referral to a pain clinic.
16161431|NCT01692262|Drug|Intermittent dosing of AZD5363|Intermittent dosing of AZD5363: oral solid formulation, twice daily (480 mg bid 4 days on and 3 days off). Recruitment suspended and will not be re-opened.
16161432|NCT01692262|Drug|Intermittent dosing of AZD5363|Intermittent dosing of AZD5363: oral solid formulation, twice daily (480 mg bid 4 days on and 3 days off). Treatment to begin on Day 1 and to continue to study withdrawal. Recruitment complete.
16161433|NCT01692262|Drug|Intermittent dosing of AZD5363|Intermittent dosing of AZD5363: oral solid formulation, twice daily (480 mg bid 4 days on and 3 days off). Treatment to begin on Day 1 and to continue until study drug withdrawal. This part of the study will not be conducted.
16161434|NCT01692249|Other|immediate spa therapy|, with 18 days of therapy over 3 weeks; The standardized shoulder therapy program was designed by experienced spa therapy physicians. Spa mineral water and treatments are approved and controlled by the French authorities. Spa treatment included: bubble buses at 36°C for 15 minutes, applications of mineral matured mud at 45°C to the shoulder for 20 minutes, mineral hydrojet sessions at 39°C for 7 minutes and general mobilization in a collective mineral water pool at 35°C for 20 minutes supervised by a registered physiotherapist.
16161435|NCT01692223|Behavioral|qualitative interviews|A week before the participants return to the clinic to learn of their results, the RSA will call each participant to complete the Hospital Anxiety & Depression Scale (HADS), revised Impact of Events Scale (IES-R), & a questionnaire about their health behaviors, to establish baseline distress levels & health behaviors. A week later, participants will return to the Clinical Genetics Service to review their results with the genetics provider & discuss resultant therapeutic & management recommendations for the participants & their relatives. A week later, the RSA will call each participant to complete the HADS, IES-R again, to establish the safety of receiving these results. Participants will also be asked to complete the revised Multidimensional Impact of Cancer Risk Assessment (MICRA) measure. The RSA will also invite participants to complete an in-depth telephone interview.
16161436|NCT01692210|Drug|Dexmedetomidine|After induction of general anesthesia, a loading dose of dexmedetomidine (1 mcg/kg) given in 15 min followed by an infusion of the same medication at a rate of 0.4 - 0.7 mcg/kg/hour.
16161437|NCT01692197|Drug|E7070|400 mg/m2 intravenously over 1 hour on Day 1 and Day 8 every 3 weeks.
16161438|NCT01692197|Drug|Idarubicin|8 mg/m2 by vein over 1 hour daily for 3 days (Days 9-11).
16161439|NCT01692197|Drug|Cytarabine|1.0 g/m2 by vein daily on Days 9 - 12 (age <60 years) or Days 9 - 11 (age > 60 years).
16161440|NCT01692197|Drug|Dexamethasone|10 mg by vein daily for 3 - 4 days with cytarabine.
16161441|NCT01692184|Drug|50 mg AVL-292|
16161442|NCT01692184|Drug|100 mg AVL-292|
16161443|NCT01692184|Drug|200 mg AVL-292|
16161444|NCT01692184|Drug|350 mg AVL-292|
16161445|NCT01692184|Drug|Placebo capsules|
16161446|NCT01692171|Drug|Heparin, Low-Molecular-Weight|single intravenous administration of 3mg/Kg of the test drug and the comparator drug, according to randomization, in a crossover design, each administration separated by 6 days of washout.
16161447|NCT01692158|Drug|Heparin, Low-Molecular-Weight|single subcutaneuous administration of 40 mg of the test drug and the comparator drug, according to randomization, in a crossover design, each administration separated by 6 days of washout.
16161448|NCT01692145|Drug|KCT-0809|
16161449|NCT01692145|Drug|Placebo|
16161450|NCT01692132|Drug|Prucalopride|Prucalopride 2 mg tablet/day orally for 12 weeks. For elderly patients (>65 years old), patients with renal impairment not requiring dialysis or patients with severe hepatic impairment, 1mg prucalopride once daily should be given.
16161451|NCT01692119|Behavioral|Regular, pharmacy based intervention|"Regular, pharmacy-based intervention conducted in cooperation with the treating physician:
~Medication review at baseline: recording of all medicines currently taken (prescribed medication and self-medication), check for drug-related problems, consolidation of a medication plan.
~Regularly (weekly): dose-dispensing of the medication (weekly dosing aid), discussion and counseling regarding medication, adherence, potential side effects, and signs and symptoms of cardiac decompensation; blood pressure and pulse measurement. If required: contact with patients' physician."
16161452|NCT01692106|Procedure|Procedure: Per Oral Endoscopic Myotomy (POEM)|lower esophageal sphincter muscle is sectioned through an unique endoscopic approach.
16161453|NCT01692093|Dietary Supplement|KM110329|KM110329, a functional food consist of four herbs which are shown to be beneficial for skin health
16161454|NCT01692093|Dietary Supplement|Placebo|Placebo
16161455|NCT01692080|Behavioral|Asthma education|Two separate asthma education classes are conducted to target two age groups: 6-10 yrs and 10-15 yrs. With the guidance of pharmacy faculty, student pharmacists develop innovative educational activities directed at three of the most common barriers to proper asthma control: avoidance of asthma triggers; compliance with asthma medications and proper usage of inhalers; and the importance of an asthma action plan. There is a different group of student pharmacists participating in each camp and this allows for variation in educational activities, all reinforcing the same important aspects of optimal asthma management. Students create age-appropriate activities for each group. Parents are required to attend camps with their child and participate in the asthma education sessions.
16234631|NCT01126424|Drug|Oxybutynin|capsule
16161463|NCT01692002|Dietary Supplement|Sodium Chloride|Placebo capsule or tablet
16161464|NCT01692002|Procedure|Oral glucose tolerance test|
16161465|NCT01692002|Procedure|Intravenous glucose tolerance test.|
16161466|NCT01691989|Drug|aleglitazar|150 mcg orally once a day for 26 weeks
16161467|NCT01691989|Drug|placebo|oral doses once a day for 26 weeks
16161468|NCT01691976|Drug|Oestrogen Patches|
16161469|NCT01691976|Drug|LHRHa|Luteinising hormone releasing-hormone agonists (LHRHa)
16161470|NCT01691963|Device|C-MAC® videolaryngoscope (Karl Storz, Tuttlingen, Germany)|"Endotracheal intubation will be achieved using a C-MAC® videolaryngoscope (Karl Storz, Tuttlingen, Germany) with a size 3 Macintosh blade.
~The best possible view of the glottic inlet will be scored with the blade tip positioned in the vallecula.
~Next, the view of the glottic inlet will be scored with the blade advanced further into the vallecula, until the epiglottis flips infero-posteriorly and becomes downfolded into the trachea.
~The glottic view will be scored in both positions using the Cormack and Lehane classification system.
~After successful intubation, the blade will slowly be withdrawn into the vallecula to elevate the epiglottis back to its normal position."
16161471|NCT01691937|Procedure|Continuous Paravertebral block with ropivacaine|Before anesthesia, continuous right thoracic paravertebral block of T7 is performed. After injection of 5 mL normal saline, a catheter (PAJUNK, Geisingen, Germany) is advanced medially the estimated distance to the paravertebral space. After injection of 1% lidocaine 15ml, the block level is tested by pinprick and recorded 15 minutes later. At the end of operation, syringe contained 0.2% ropivacaine is connected to paravertebral catheter, a 10ml bolus of 0.2% ropivacaine is injected via the paravertebral catheter, followed by an infusion of ropivacaine 0.2% at 6 ml/h for postoperative pain management.
16161472|NCT01691937|Procedure|Patient-controlled analgesia with sufentanil|Once arrival at the PACU, all patients were placed on a postoperative analgesic regimen that included patient-controlled analgesia with intravenous sufentanil (bolus 1μg, lockout time 10 min) and tramadol 100 mg IV for severe pain (NRS 6-10).
16161473|NCT01691937|Procedure|Continuous Paravertebral Block with Saline|Before anesthesia, continuous right thoracic paravertebral block of T7 is performed. After injection of 5 mL normal saline, a catheter (PAJUNK, Geisingen, Germany) is advanced medially the estimated distance to the paravertebral space. After injection of 1% lidocaine 15ml, the block level is tested by pinprick and recorded 15 minutes later. At the end of operation, syringe contained 0.9% saline is connected to paravertebral catheter, a 10ml bolus of 0.9% saline is injected via the paravertebral catheter, followed by an infusion of 0.9% saline at 6 ml/h for postoperative pain management.
16161474|NCT01691924|Drug|PBF-509|
16161475|NCT01691924|Drug|Placebo|
16161476|NCT01691911|Procedure|Remote preconditioning|Immediately after induction of anaesthesia, a standard, CE-approved tourniquet cuff will be placed around one arm of the patient. It will then be inflated to a pressure of 200mmHg for 5 minutes. For patients with a systolic blood pressure >185mmHg, the cuff will be inflated to at least 15mmHg above the patient's systolic blood pressure. The cuff will then be deflated and the arm allowed reperfuse for 5 minutes. This will be repeated so that each patient receives a total of 4 ischaemia-reperfusion cycles. In all other respects, the procedure and peri-operative care will follow the routine practices of the surgeons and anaesthetists involved.
16161477|NCT01691898|Drug|Obinutuzumab|Obinutuzumab 1000 mg will be administered by IV infusion on Days 1, 8, 15 of first 21-Day cycle and on Day 1 of subsequent 21-day cycles for up to 8 cycles.
16161478|NCT01691898|Drug|Pinatuzumab Vedotin|Pinatuzumab Vedotin 1.8 or 2.4 mg/kg administered by IV infusion on Day 1 or 2 of every 21-day cycle.
16161479|NCT01691898|Drug|Polatuzumab Vedotin|Polatuzumab Vedotin 1.8 or 2.4 mg/kg administered by IV infusion on Day 1 or 2 of every 21-day cycle.
16161480|NCT01691898|Drug|Rituximab|RTX 375 mg/m^2 administered by IV infusion on Day 1 of every 21-day cycle.
16161481|NCT01691885|Drug|Fluticasone Furoate|100mcg Once daily
16161482|NCT01691885|Drug|Vilanterol|25mcg Once daily
16161483|NCT01691872|Drug|Retigabine|Retigabine
16161484|NCT01691859|Drug|Mepolizumab|100 mg of mepolizumab will be injected subcutaneously (SC) once every 4 weeks
16161485|NCT01691846|Drug|aleglitazar+metformin|150 mcg aleglitazar given orally once a day for 26 weeks. Patients will continue on their existing dose and regimen of metformin (≥ 1500 mg/day or individual maximally tolerated dose)
16161486|NCT01691846|Drug|placebo+metformin|Oral doses of matching placebo once a day for 26 weeks. Patients will continue on their existing dose and regimen of metformin (≥ 1500 mg/day or individual maximally tolerated dose)
16161487|NCT01691833|Dietary Supplement|Vitamin D|Patients that are Vitamin D deficient and randomized to the treatment group will receive a 10,000 IU dose of Vitamin D.
16161488|NCT01691833|Dietary Supplement|Placebo|Patients that are Vitamin D deficient maybe randomized to the placebo group D.
16161489|NCT01691820|Procedure|Blood collection|Samples collected at Months 0, 4, 8, 12, 16, 20, 24, 28, 32, and 36.
16161490|NCT01691820|Procedure|Urine collection|Samples collected at Months 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36.
16161491|NCT01691820|Procedure|Saliva collection|Samples collected at Months 0, 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, 34, and 36.
16161492|NCT01691807|Drug|ofatumumab|treatment for NHL
16161493|NCT01691807|Drug|bendamustine|treatment for NHL
16161494|NCT01691794|Drug|Atazanavir|
16161495|NCT01691794|Drug|Ritonavir|
16161496|NCT01691781|Drug|Lisinopril|Each subject will receive one week of lisinopril and return for repeat for blood measurements.
16161497|NCT01691768|Drug|1% tenofovir gel|"Participants will be randomized to receive 1% tenofovir gel through either:
~Public sector family planning services with 2-3 monthly provision and monitoring of 1% tenofovir gel and the use of QI methodology to promote reliable service delivery (intervention arm), or
~The CAPRISA research clinics with monthly provision and monitoring of 1% tenofovir gel (control arm)."
16161498|NCT01691755|Drug|Placebo|oral doses once a day for 26 weeks
16161499|NCT01691755|Drug|aleglitazar|150 mcg orally once a day for 26 weeks
16161500|NCT01691742|Drug|MiraLax|MiraLax 17g powder daily for 5 days postoperatively following urogynecologic surgery
16161501|NCT01691742|Drug|Placebo|Placebo maltodextrin 17g powder daily for 5 days postoperatively following urogynecologic surgery
16161540|NCT01691521|Drug|Mepolizumab IV|Mepolizumab 75 mg IV will be administered every 4 weeks with the last dose at Week 28
16234632|NCT01126424|Drug|Placebo|tablet
16161502|NCT01691742|Drug|Rescue Laxative|All participants will be instructed to take Milk of Magnesia with standard over-the-counter dosing as a recue laxative if the subject has not had a bowel movement by postoperative day 6.
16161503|NCT01691729|Device|Ostomy accessory|Wearing each of the devices for 10 days each
16161504|NCT01691716|Drug|Tendoactive|Food supplement containing mucopolysaccharides, type I collagen and vitamin C
16161505|NCT01691716|Behavioral|Eccentric training|Eccentric training program published by Alfredson et al 1998 (Am J Sports Med 1998 26: 360)
16161506|NCT01691703|Device|Videolaryngoscope and Bonfils|First, the Macintosh videolaryngoscope (Karl Storz, Tuttlingen, Germany) will be used to achieve the best possible view and space of the laryngeal inlet for the insertion and manoeuvring of the Bonfils® (Karl Storz, Tuttlingen, Germany). Once the anaesthesiologist considers the view achieved to be the best view possible, a picture will be taken using C-CAMTM for C-MAC (Karl Storz, Tuttlingen, Germany), not showing any part of the videolaryngoscope. Thereafter the Bonfils® intubation scope, which will be preloaded with the endotracheal tube, will be brought into position in front of the laryngeal inlet. Again a picture not showing any part of one of the two devices will be taken. Once the Bonfils® has entered the trachea, the tracheal tube will be placed in the correct position.
16161507|NCT01691690|Drug|Acetaminophen (paracetamol)|Acetaminophen IV (15 mg/kg).
16161508|NCT01691690|Drug|Normal Saline Flush|Saline placebo will be infused intraoperatively.
16161509|NCT01691690|Drug|Midazolam|Midazolam (0.5mg/kg to maximum dose of 20mg) given 15-20 minutes before induction.
16161510|NCT01691690|Drug|Sevoflurane|Sevoflurane for anesthesia induction.
16161511|NCT01691690|Drug|Nitrous Oxide/Oxygen|Combination of NO2 & O2 for anesthesia induction.
16161512|NCT01691690|Drug|Propofol|Propofol 1-1.5 mg/kg to facilitate endotracheal intubation.
16161513|NCT01691690|Drug|Morphine|Morphine 0.1 mg/kg given prior to intubation.
16161514|NCT01691690|Drug|Ondansetron|Ondansetron (0.15 mg/kg, maximum dose of 4 mg) for postoperative nausea prophylaxis.
16161515|NCT01691690|Drug|Dexamethasone|Dexamethasone (0.25 mg/kg, maximum dose of 20 mg) for postoperative nausea prophylaxis.
16161516|NCT01691677|Drug|beclomethasone dipropionate 800 mcg/2 ml suspension for nebulization,one administration b.i.d. for 14 days|
16161517|NCT01691677|Drug|placebo 2 ml suspension for nebulization, one administration b.i.d. for 14 days|
16161518|NCT01691664|Radiation|Only radiation therapy|Patients only radiation therapy after surgery
16161519|NCT01691664|Other|Radiation therapy plus DC-CIK cellular therapy|Patients receive radiation therapy plus DC-CIK cellular therapy after surgery
16161520|NCT01691651|Procedure|Subcutaneous injection of botulinum toxin type A|Subcutaneous injection of botulinum toxin type A (2.5 units per application point) at two points in a nasal and temporal extent of the orbicularis muscle will be performed in the Botulinum toxin type A group.
16161521|NCT01691651|Drug|Botulinum Toxin Type A|2.5 units per point of application at two points in a nasal and temporal extent of the orbicularis muscle.
16161522|NCT01691625|Other|concurrent chemoradiotherapy plus DC-CIK immunotherapy|"Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) or Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.
~Chemotherapy: Patients will be concurrently administered with irradiation every 4 weeks with PT regimen (cis-platinum of 20 mg/m2/d, d2-5; PTX(paclitaxel)of 80mg/m2/d, d1,d8) for 4 cycles.The chemotherapy will be concurrently given with irradiation.
~DC-CIK Immunotherapy:Mononuclear cells were collected aseptically with blood cell separator composition apheresis 3 days before concurrent chemoradiation, and cultured DC-CIK cells for 10 days. Cells were infused back to the patients in 3 times between the Chemoradiation intermittent period."
16161523|NCT01691625|Other|Concurrent chemoradiation only|"Radiotherapy:Patients will be conducted CT simulation, and three-dimensional conformal radiation therapy (3DCRT) or Intensity-modulated radiation therapy(IMRT)was performed. 1.8-2.0 Gy/fraction, 5 fractions a week, with a total dose of 60-66Gy will be delivered for all patients by 6-MV-X-ray of linear accelerator.
~Chemotherapy: Patients will be concurrently administered with irradiation every 4 weeks with PT regimen (cis-platinum of 20 mg/m2/d, d2-5; PTX(paclitaxel)of 80mg/m2/d, d1,d8) for 4 cycles.The chemotherapy will be concurrently given with irradiation."
16161524|NCT01691612|Biological|installation of D. pteronyssinus allergens|We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later
16161525|NCT01691586|Device|Remote patient monitoring|Remote monitoring of ICD and heart failure data
16161526|NCT01691586|Other|In-Clinic check-ups|Calender-based In-Clinic ICD check-up
16161527|NCT01691560|Drug|5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice|Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate
16161528|NCT01691560|Drug|0% calcium sodium phosphosilicate/sodium monofluorophosphate dentifrice|Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate
16161529|NCT01691560|Drug|Sodium monofluorophosphate dentifrice|Dentifrice containing 1000 ppmF as sodium monofluorophosphate
16161530|NCT01691560|Drug|Sodium fluoride dentifrice|Dentifrice containing 1100 ppmF as sodium fluoride
16161531|NCT01691547|Drug|UMEC /VI|Umeclidinium is an inhaled long-acting muscarinic antagonist (LAMA) and vilanterol is a long-acting beta2 agonist (LABA). UMEC/VI (blended together) will be available as dry powder in the dose of 125 µg /25 µg per inhalation.
16161532|NCT01691547|Drug|UMEC|Umeclidinium is an inhaled long-acting muscarinic antagonist (LAMA). UMEC will be available as dry powder in the dose of 125 µg per inhalation.
16161533|NCT01691547|Drug|VI|Vilanterol is a long-acting beta2 agonist (LABA). VI will be available as dry powder in the dose of 25 µg per inhalation.
16161534|NCT01691547|Drug|FF|Fluticasone Furoate is a novel inhaled corticosteroid (ICS). FF will be available as dry powder in the dose of 100 µg per inhalation.
16161535|NCT01691534|Drug|TMC207 (J)|TMC207 400 mg Day 1; 300mg Day 2; 200mg Days 3-14
16161536|NCT01691534|Drug|PA-824 (PA)|PA-824 200mg Days 1-14
16161537|NCT01691534|Drug|pyrazinamide (Z)|1500mg Days 1-14 Dosed by Weight
16161538|NCT01691534|Drug|clofazimine (C)|clofazimine 300mg Days 1-3 and clofazimine 100mg Days 4-14
16161539|NCT01691534|Drug|Rifafour|Rifafour e-275 mg dosed by weight
16161541|NCT01691521|Drug|Mepolizumab SC|Mepolizumab 100 mg SC will be administered every 4 weeks with the last dose at Week 28
16161542|NCT01691521|Drug|IV Placebo|Normal saline (placebo) will be administered IV every 4 weeks with the last dose at Week 28
16161543|NCT01691521|Drug|SC Placebo|Normal saline (placebo) will be administered SC every 4 weeks with the last dose at Week 28
16161544|NCT01691508|Drug|Mepolizumab|Mepolizumab is a fully humanised Immunoglobulin G antibody (IgG1, kappa) with human heavy and light chain frameworks.
16161545|NCT01691508|Drug|Placebo|Will be available as an equivalent volume of 0.9% sodium chloride.
16161546|NCT01691508|Drug|OCS (prednisone/prednisolone)|Oral Corticosteroid (prednisone/prednisolone)
16161547|NCT01691495|Drug|Fondaparinux|Physician adherence study to Fondaparinux prescribing information for patients with Superficial Vein Thrombosis (SVT) of the lower limbs
16161548|NCT01691482|Drug|Albuterol/salbutamol|Albuterol/salbutamol (daily)
16161549|NCT01691482|Drug|Ipratropium|Ipratropium (daily)
16161550|NCT01691469|Drug|Montelukast sodium|Montelukast Sodium Oral Granules 4mg
16161551|NCT01691456|Drug|Montelukast sodium|Montelukast Sodium Oral Granules 4mg
16161552|NCT01691443|Procedure|pressure sensor and wrist shaker, not marked CE, developped by Texisense|
16161553|NCT01691430|Dietary Supplement|2 cranberry capsules|Two cranberry capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
16161554|NCT01691430|Dietary Supplement|Placebo|Two placebo capsules qd (each capsule containing 36mg proanthocyanidin, total 72mg PAC)
16161555|NCT01691417|Device|Intermittent Sequntial Pnumatic Compression Leg Sleeves|
16161556|NCT01691404|Dietary Supplement|Epicatechin|Subjects will be asked to consume supplements containing 100mg of epicatechin daily
16161557|NCT01691404|Dietary Supplement|Quercetin|Subjects will be asked to consume 160mg of quercetin-3-glucoside daily
16161558|NCT01691404|Dietary Supplement|Placebo|Subjects will be asked to consume capsules containing placebo (cellulose) daily
16161559|NCT01691391|Behavioral|(Early) Imaging of response with [18F-]-FDG PET-CT and kinase activity profiles|Patients will be treated with cetuximab or panitumumab. Two [18F-]-FDG PET-CT will be performed to explore early response. Patients will undergo blood sampling and two skin and tumor biopsies for kinase activity profiles.
16161560|NCT01691378|Other|Window to Hope|Psychotherapy - Group
16161561|NCT01691378|Other|Waitlist Control|Members of the Waitlist Control arm continued to receive nonconstrained usual care from the Veterans Health Administration. Those initially allocated to the Waitlist Control arm were later provided with the opportunity to cross over and receive the WtoH Intervention after Time 2.
16161562|NCT01691365|Dietary Supplement|vitamins|a capsule of antioxidant vitamins 221mg of alpha tocopherol and 167mg of vitamin C and B-group vitamins (1.67 mg folic acid, 1.67mg vitamin B-2, 20 mg vitamin B-6, 0.134 mg vitamin B-12) or an identical placebo daily for 90 days
16161563|NCT01691365|Drug|Placebo|Placebo Capsule shell (Hydroxypropylmethyl cellulose, Hydroxypropylcellulose, Propylene glycol as stabilizer, Colour-Titanium dioxide)
16161564|NCT01691352|Procedure|Wick dressing|Once the fascia of the ostomy site is closed, the subcutaneous space will be irrigated with normal saline. The skin will then be reapproximated using an absorbable suture, spaced every 1 cm across the wound (i.e. for a 2cm wound, a single suture will be placed in the middle). A moist, saline/betadine soaked gauze will then be gently packed into the wound spaces, on either side of the sutures. The gauze will be packed into the wound to the depth of ½ a cm, or ½ of the wound depth, whichever is greater. A single dry piece of gauze will then be secured over the top of the wound. Dressings and packing will be removed by the surgical team on post-operative day 2
16161565|NCT01691352|Procedure|No Wick|Once the fascia of the ostomy site is closed, the subcutaneous space will be irrigated with normal saline. The skin will then be reapproximated using an absorbable suture, spaced every 1 cm across the wound (i.e. for a 2 cm wound, a single suture will be placed in the middle). A single piece of dry gauze will then be secured over the top of the wound. Dressings will be removed by the surgical team on post-operative day 2
16161566|NCT01691339|Biological|Influenza Virus Vaccine: Fluzone® 2012-2013 Formulation|0.5 mL, Intramuscular
16161567|NCT01691339|Biological|Influenza Virus Vaccine: Fluzone® Intradermal 2012-2013 Formulation|0.1 mL, Intradermal
16161568|NCT01691339|Biological|Influenza Virus Vaccine: Fluzone® 2012-2013 Formulation|0.5 mL, Intramuscular
16161569|NCT01691339|Biological|Influenza Virus Vaccine: Fluzone® High-Dose 2012-2013 Formulation|0.5 mL, Intramuscular
16161570|NCT01691326|Biological|Fluzone®: Influenza Virus Vaccine, No Preservative: Pediatric Dose|0.25 mL dose, Intramuscular
16161571|NCT01691326|Biological|Fluzone®; Influenza Virus Vaccine, No Preservative|0.5 mL dose, Intramuscular
16161572|NCT01691313|Drug|Vanoxerine|single oral dose
16161573|NCT01691313|Drug|Placebo|single oral dose
16161574|NCT01691300|Other|ACT PET/CT|Old tracer but new indication
16161575|NCT01691287|Behavioral|Michael Method|
16161576|NCT01691274|Drug|PF-04895162|Tablets, 300 mg, single, 1 day
16161577|NCT01691274|Drug|PF-04895162|Tablets, 300 mg, twice a day, 14 days
16161578|NCT01691274|Drug|PF-04895162|Tablets, to be decided, twice a day, 14 days
16161579|NCT01691274|Drug|Placebo|Tablets, twice a day, 14 days
16161580|NCT01691261|Biological|PF-05206388|PF-05206388 will be provided as a Retinal Pigment Epithelium living tissue equivalent for intraocular use in the form of a monolayer of Retinal Pigmented Epithelial (RPE) cells immobilized on a polyester membrane. The membrane is approximately 6 mm x 3 mm and will contain a confluent layer of RPE cells, at a nominal dose of 17 mm2. The implant is intended to be life-long.
16161581|NCT01691248|Drug|fidaxomicin|"Fidaxomicin 200 mg tablet once daily from the start (+/- 2 days) of condition (prior to transplantation) or at the time of Fluoroquinolone initiation. Study drug treatment will continue until 7 days after either neutrophil engraftment or the completion of any Fluoroquinolone antibiotic regimen (whichever occurs later).
~Study drug treatment will stop at onset of CDAD or no longer than 40 days of duration, even if other antibiotics are still administered or neutrophil engraftment extends beyond 40 days."
16161625|NCT01690897|Behavioral|Sex therapy, education, and support treatment|The sex therapy, education, and support group will consist of all of the same techniques and materials in the MBCT group except for the mindfulness components in group sessions and at-home practices.
16161815|NCT01689519|Drug|Vemurafenib|Vemurafenib supplied as tablets
16161582|NCT01691248|Drug|Placebo|"Placebo tablet once daily from the start (+/- 2 days) of condition (prior to transplantation) or at the time of Fluoroquinolone initiation. Treatment will continue until 7 days after either neutrophil engraftment or the completion of any Fluoroquinolone antibiotic regimen (whichever occurs later).
~Treatment will stop at onset of CDAD or no longer than 40 days of duration, even if other antibiotics are still administered or neutrophil engraftment extends beyond 40 days."
16161583|NCT01691235|Device|SIMpill device|The SIMpill device is an automated pill dispensing device that records a time stamp each time the device is opened and a dose of medication is taken. This works through a computer chip that is housed inside of the pill dispensing device that is activated each time the pill box is opened. Physicians can download this data and generate a precise account of the patient's adherence to the medication dosing schedule. In addition, if a dose is missed, the SIMpill device can be set to automatically notify the patient by text message if a dose is overdue.
16161584|NCT01691222|Device|Double lumen endotracheal tube tracheostomy|"Percutaneous tracheostomy in this study will be performed with the use of a dedicated double-lumen endotracheal tube.
~The dedicated double-lumen endotracheal tube (Deas S.R.L, Italy) has an upper and a lower lumen. The upper one will be occupied by flexible fiberoptic bronchoscope while the lower one is exclusively dedicated to patient ventilation during the procedure. The lower lumen has a a semi-elliptical cross section. This tube will be placed in the patient airway with a direct laryngoscopy. After this intubation, a percutaneous dilatational tracheostomy will be performed with the standard techniques recognised in the literature."
16161585|NCT01691209|Device|Phoenix (BAY81-2996)|Topical formulation applied to the skin
16161586|NCT01691209|Drug|1% Hydrocortison cream|1% Hydrocortison cream applied to the skin
16161587|NCT01691170|Other|Stretching Hamstring|
16161588|NCT01691170|Other|Quadriceps Strengthening|
16161589|NCT01691157|Other|Evidence based exercise protocol|An evidence based graduated exercise rehabilitation protocol will be provided and supervised by a physiotherapist. patients will receive 6 sessions of supervised physiotherapy
16161590|NCT01691157|Other|Usual physiotherapy without exercise|Will receive modified usual physiotherapy care that can consist of any physiotherapeutic modalities normally provided except exercise. this may consist of postural advice, taping, electrotherapy, acupuncture, manual joint mobilizations of the shoulder, cervical or thoracic spine.
16161591|NCT01691131|Other|Exercise training|Comparison of high intensity exercise training on land versus water.
16161592|NCT01691118|Drug|Fimasartan|
16161593|NCT01691118|Drug|Antihypertensive treatment|
16161594|NCT01691105|Other|AD + Integrated Tobacco Order Set|"Physician will have access to:
~NRT with dosing instructions Bupropion and varenicline with dosing instructions Automated referral to the CT Quitline Automated fax to PCP Discharge prescription prompt Quitline report sent to PCP 2 day call back from hospital call center"
16161595|NCT01691092|Drug|Ketamine|All subjects will receive ketamine to induce glutamate release in the brain
16161596|NCT01691079|Drug|ipratropium bromide|Inhaled ipratropium bromide administered before exercise.
16161597|NCT01691079|Drug|Placebo|Inhaled placebo administered before exercise.
16161598|NCT01691066|Behavioral|Infant Toddler Years PRT|
16161599|NCT01691053|Drug|Spironolactone|50mg once daily
16161600|NCT01691053|Drug|Placebo|Placebo
16161601|NCT01691040|Drug|NOX-H94|intravenous injection
16161602|NCT01691040|Drug|Placebo solution|intravenous injection
16161603|NCT01691027|Behavioral|Visuo-motor training|Participants will undergo training on three developed software modules on Samsung Galaxy Note Pro tablets to see their effect on low vision rehabilitation
16161604|NCT01691014|Other|non-interventional study|Study with 4 arms/groups with 36 patients per group. In total 144 patients.
16161605|NCT01691014|Other|non-interventional study|Study with 4 arms/groups with 36 patients per group. In total 144 patients.
16161606|NCT01691014|Other|non-interventional study|Study with 4 arms/groups with 36 patients per group. In total 144 patients.
16161607|NCT01691014|Other|non-interventional study|Study with 4 arms/groups with 36 patients per group. In total 144 patients.
16161608|NCT01691001|Drug|Dexmedetomidine|dexmedetomidine(vs saline) 1 mcg/kg iv bolus during 10minutes, and then, 0.1 mcg/kg/h dexmedetomidine(vs saline) was infused.
16161609|NCT01691001|Drug|normal saline|
16161610|NCT01690988|Drug|Ketamine (0.5 mg/kg)|Low dose (sub-anesthetic) 0.5 mg/kg ketamine following induction of anesthesia or administration of sedative medications.
16161611|NCT01690988|Drug|Normal Saline (placebo)|Normal saline IV following induction of anesthesia or administration of sedative medications
16161612|NCT01690988|Drug|Ketamine (1 mg/kg)|Low dose (sub-anesthetic) 1 mg/kg ketamine following induction of anesthesia or administration of sedative medications.
16161613|NCT01690975|Drug|Placebo|Placebo - single dose at start of each treatment period
16161614|NCT01690975|Drug|Benzonatate - 400 mg|Benzonatate - 400 mg single dose
16161615|NCT01690975|Drug|Benzonatate - 600 mg|Benzonatate - 600 mg single dose
16161616|NCT01690962|Other|Vegan diet and vitamin B12 supplement|A low-fat, vegan diet (no meat, fish, eggs or dairy products) and a vitamin B12 supplement in the form of 2000mcg of methylcobalamin
16161617|NCT01690962|Dietary Supplement|Vitamin B12 supplement|A daily vitamin B12 supplement in the form of 2000mcg of methylcobalamin
16161618|NCT01690949|Drug|PUR118|inhaled PUR118, BID
16161619|NCT01690936|Dietary Supplement|Almonds 43g/day|43 grams of almonds were supplemented to the 4 intervention arms but eaten at different times of day (with meals or alone as snacks) for 4 weeks. Control group was asked to avoid all nuts/seeds during the study period
16161620|NCT01690923|Device|Nasal mask|Nasal mask (Mirage Activa, Micro, FX)
16161621|NCT01690923|Device|Pillows mask|Nasal pillows mask (Swift FX)
16161622|NCT01690910|Device|Rifton Gait Trainer|
16161623|NCT01690910|Device|Front Wheeled Walker|
16161624|NCT01690897|Behavioral|Mindfulness-based treatment|The mindfulness-based treatment for the MBCT group treatment consists of eight 2-hour long weekly sessions, based on a variety of empirically supported techniques, and integrates elements of education, mindfulness skills, and sex therapy. In addition, participants are also given handouts and asked to complete approximately 10-60 minutes/day of at-home practice/skills, which may include reading material, mindfulness exercises, and behavioural exercises between sessions.
16240543|NCT01081548|Drug|atorvastatin|20 mg
16161626|NCT01690884|Drug|Adenosine|Adenosine will be infused into the brachial artery at 0.125 mg/min for 15 minutes and then at 0.5 mg/min for an additional 15 minutes,
16161627|NCT01690871|Drug|BEZ235|Patients will be provided with an adequate supply of study treatment for self-administration at home. Unless otherwise warranted, new study drug packages will be provided to the patient at Cycle 1 Day 1 (start of treatment) and at Day 1 of each following treatment cycle. The first dose of BEZ235 (Cycle1 Day1) must be taken at the hospital.
16161628|NCT01690858|Other|blood sample|blood sampling at inclusion and throughout pregnancy when pregnant
16161629|NCT01690845|Device|MARS|Molecular adsorbent recirculating system (MARS®) can be used in patients with acute liver failure for bridging to liver transplantation. Studies reported that MARS® therapy improved the hemodynamic situation in patients with acute and acute on chronic liver failure. Several groups observed an increase in arterial pressure, systemic vascular resistance index, a decrease in portal pressure and improvement of renal blood flow. Furthermore, studies demonstrated that MARS therapy reduces ammonia levels and improves hepatic encephalopathy.
16161630|NCT01690832|Drug|standard saline infusion|i.v. 1 ml/kg/h saline infusion from 6 hours before the procedure to 12 hours after the procedure
16161631|NCT01690832|Drug|fenoldopam infusion|combination of i.v. 1 ml/kg/h saline infusion and fenoldopam administration (0.08 mcg/Kg/min) from 6 hours before the procedure to 12 hours after the procedure
16161632|NCT01690819|Procedure|Conventional Ventilatory Strategy|The conventional strategy will be the standard of care with a lower limit of tidal volume equal to 8 ml/Kg of predicted body weight and with a PEEP of 4 cmH2O
16161633|NCT01690819|Procedure|Protective Ventilatory Strategy|The protective strategy will consist of a tidal volume of 6 ml/Kg of predicted body weight, with a PEEP of 8 cmH2O
16161634|NCT01690780|Drug|Oral morphine|oral morphine 0.5 mg/kg (max 10 mg) every 6 hours as needed for 24 hours
16161635|NCT01690780|Drug|Ibuprofen|Ibuprofen 10 mg/kg (max 600 mg) every 6 hours as needed for pain (maximum 4 doses) for 24 hours following discharge from the emergency department
16161636|NCT01690767|Drug|2% lidocaine gel|Children < 7 kg and > 7 kg will receive 1 cc and 1.5 cc of 2% lidocaine gel, respectively
16161637|NCT01690767|Drug|Health Care Lubricating Jelly|Non-medicinal lubrication gel
16161638|NCT01690754|Other|Interactive Reminders|Daily SMS reminders sent to TB patients at a pre-specified time. They are asked to respond to the reminders. If a response is not received within two hours, they are sent another reminder for up to three per day.
16161639|NCT01690741|Drug|Nerofe|Nerofe administered intravenously 3x/week
16161640|NCT01690728|Behavioral|Physical Activity|The intervention program will continue for six month consisting of two weekly sessions of 40 min exercise supervised by physiotherapists. The supervised exercise program will take place at the training center Fitness.dk in Esbjerg and Kolding. It will be in cooperation with physiotherapists at the Therapy Department of Sydvestjysk Sygehus Esbjerg and the Therapy Department of Fredericia and Kolding Sygehus, Sygehus Lillebælt. The exercise program at the two centers will be equal. In addition the patients will be provided with free access to a fitness center. The patient will be encouraged to do at least 3.5 hours of moderate to vigorous physical activity per week.
16161641|NCT01690702|Drug|Epirubicin|
16161642|NCT01690702|Drug|nab-Paclitaxel|
16161643|NCT01690702|Drug|Cyclophosphamide|
16161644|NCT01690702|Drug|Docetaxel|
16161645|NCT01690689|Device|Implant surgery|surgery
16161646|NCT01690676|Dietary Supplement|Epicatechin|
16161647|NCT01690676|Dietary Supplement|Microcrystalline cellulose|
16161648|NCT01690663|Drug|Bupivacaine 0.25%|
16161649|NCT01690663|Drug|Dexamethasone|
16161650|NCT01690663|Drug|normal saline|placebo
16161651|NCT01690650|Drug|Oxygen|Oxygen exposure (100% oxygen) for 5 minutes, then 25 minutes with room air. Repeated twice. Continuously monitoring of the cerebral oxygen saturation (NIRS).5 replacements of sensor for reproducibility.
16161652|NCT01690637|Drug|Oseltamivir phosphate suspension|
16161653|NCT01690637|Drug|Placebo|
16161654|NCT01690624|Drug|BI 836858|Monotherapy with BI 836858 administered as intravenous infusion
16161655|NCT01690611|Procedure|Treadmill Walking|"Individuals will walk at a comfortable speed on a treadmill without holding on to the hand rails."
16161656|NCT01690611|Other|Visual Feedback|Real time feedback regarding body motion while walking.
16161657|NCT01690598|Drug|Veliparib|Veliparib (tablet) twice daily on days 1-3, 7-9, and 14-16 in a 28 days cycle. In phase I the starting dose is 30 mg x 2.
16161658|NCT01690598|Drug|Topotecan|2 mg/m² iv over 30 minutes on days 2, 8, and 15 in cycles of 28 days. Topotecan is dosed at a maximum body surface area of 2 m².
16161659|NCT01690585|Drug|Ferinject 1000 mg|
16161660|NCT01690585|Drug|Sodium chlorure 0,9 %|
16161661|NCT01690572|Device|Paclitaxel coated balloon catheter|Dilatation of the target lesion
16161662|NCT01690572|Device|"uncoated balloon catheter sprinter legend"|Dilatation of the target lesion
16161663|NCT01690559|Drug|Cipro (Ciprofloxacin, BAYQ3939)|Patient treated with Ciproxan without dilution treatment in daily clinical practice
16161664|NCT01690546|Drug|very low dose naltrexone|On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg.
16161665|NCT01690546|Drug|extended release naltrexone|On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg.
16161666|NCT01690546|Drug|buprenorphine/naloxone|On days 1-3, participants will receive buprenorphine/naloxone daily, starting at a dose of 4 mg, progressively decreasing to 2 mg on Days 2-3 and very low dose naltrexone at 0.25 mg to 1 mg on Days 1-3, 2 to 6 mg on Day 4 and 10 mg to 50 mg on Days 5-7. VIVITROL injection will be administered on Day 8 at 380 mg.
16161667|NCT01690533|Drug|Avelox (Moxifloxacin, BAY12-8039)|Patients treated with Moxifloxacin in daily clinical practice
16161668|NCT01690520|Drug|Cyclophosphamide|Given IV
16161669|NCT01690520|Drug|Cyclosporine|Given IV or PO
16161670|NCT01690520|Biological|Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion|Given IV
16161674|NCT01690520|Radiation|Total-Body Irradiation|Undergo high dose or middle intensity TBI
16161675|NCT01690520|Procedure|Umbilical Cord Blood Transplantation|Undergo single-unit or double-unit unmanipulated umbilical cord blood transplant
16161676|NCT01690507|Drug|Decitabine|20 mg/m²/day for 5 days
16161677|NCT01690507|Drug|Cytarabine|
16161678|NCT01690507|Drug|aclacinomycin|
16161679|NCT01690507|Drug|Granulocyte colony-stimulating factor|
16161680|NCT01690507|Other|HLA haploidentical mononuclear cells infusion|
16161681|NCT01690494|Behavioral|PACT|Couple-based behavioral HIV/STI preventive intervention
16161682|NCT01690494|Behavioral|TAU|Standard treatment of care services provided to male offenders by the Criminal Court, Community Court or probation sites
16161683|NCT01690468|Drug|Triciribine|Triciribine (15, 25, 30, 35, or 45 mg/m^2) on days 1, 8, 15 every 21 days. To be given as a 60 minute IV infusion.
16161684|NCT01690468|Drug|Carboplatin|Carboplatin will be administered on day 1 every 21 days, as a 30 minute IV infusion after completion of TCN.
16161685|NCT01690442|Behavioral|Couples Based HIV/STI Risk Reduction Intervention (CHSR)|The intervention includes a combination of empowerment and couple self-efficacy building strategies, which are employed to help couples overcome resistance to risk reduction.
16161686|NCT01690442|Behavioral|Renaissance Wellness Promotion (WP)|This intervention employs a psychoeducational approach to promote wellness, focusing on: maintaining a healthy diet on a low budget, exercising and fitness, stress reducing strategies and specific health related issues that affect IDUs, such as overdose.
16161687|NCT01690429|Device|Somnocheck micro|Study nights in sleep lab with standard polysomnography plus Somnocheck micro. The Somnocheck micro is a device with pulse oxymetry and nasal cannula, which can be worn like a wristwatch. It records information about sleep disordered breathing, oxygen saturation, and pulse wave.
16161688|NCT01690416|Procedure|Traditional palpation technique|
16161689|NCT01690416|Procedure|Ultrasound DNTP|
16161690|NCT01690403|Drug|rifapentine (M000473)|"Pharmaceutical form:tablet
~Route of administration: oral"
16161691|NCT01690403|Drug|EFZ EMT TDF|"Pharmaceutical form:tablet
~Route of administration: oral"
16161692|NCT01690390|Drug|Icotinib of routine dose|Icotinib of routine dose: 125 mg is administered orally three times per day.
16161693|NCT01690390|Drug|Icotinib of high dose|Icotinib: 250 mg is administered orally three times per day.
16161694|NCT01690377|Biological|PDC or myDC|PDC or myDC; first patient 0.3 * 10E6 PDC; second and third 1 * 10E6 PDC; fourth and fifth 3 * 10E6 PDC.
16161695|NCT01690364|Other|MEP monitoring with continuous infusion of vecuronium during general anesthesia|MEP monitoring with continuous infusion of vecuronium during general anesthesia
16161696|NCT01690364|Other|MEP monitoring with continuous infusion of cisatracurium during general anesthesia|MEP monitoring with continuous infusion of cisatracurium during general anesthesia
16161697|NCT01690351|Drug|PF-05089771|Oral dispersion TS formulation- fasted
16161698|NCT01690351|Drug|PF-05089771|Capsules TS formulation- fasted
16161699|NCT01690338|Drug|Vecuronium Bromide|Administrative protocol of Vecuronium Bromide is determined by each caregiver's clinical experience.
16161700|NCT01690338|Drug|Rocuronium|Administrative protocol of rocuronium is determined by each caregiver's clinical experience.
16161701|NCT01690338|Drug|Cisatracurium|Administrative protocol of cisatracurium is determined by each caregiver's clinical experience
16161702|NCT01690325|Drug|Docetaxel|
16161703|NCT01690325|Drug|Trastuzumab|
16161704|NCT01690325|Drug|Bevacizumab|
16161705|NCT01690325|Drug|Epirubicin|
16161706|NCT01690325|Drug|Cyclophosphamid|
16161707|NCT01690312|Dietary Supplement|Fish Oil|On Day 1 and Day 15, participants will receive a 2-week supply of study supplements and will be instructed to consume 4 capsules per day. Each capsule contains 1000 mg of fish oil [620 mg of DHA and 150 mg of EPA], providing a total daily dosage of 4000 mg of fish oil [3080 mg of DHA+EPA].
16161708|NCT01690312|Dietary Supplement|Placebo|On Day 1 and Day 15, participants will receive a 2-week supply of study supplements and will be instructed to consume 4 capsules per day. Each capsule contains 1000 mg of olive oil, providing a total daily dosage of 4000 mg of olive oil.
16161709|NCT01690299|Drug|Apremilast|Apremilast 30 mg tablet orally BID
16161710|NCT01690299|Drug|Etanercept|Etanercept 50 mg evaluator/subject-blinded SC QW injection
16161711|NCT01690299|Drug|Placebo tablet|Placebo tablets BID
16161712|NCT01690299|Drug|Placebo injection|Once weekly evaluator/subject-blinded SC placebo (1 mL x 2 injections SC)
16161713|NCT01690286|Drug|JNJ-38518168 3 mg|One oral daily dose of JNJ-38518168 3 mg for 25 days.
16161714|NCT01690286|Drug|JNJ-38518168 30 mg|One oral daily dose of JNJ-38518168 30 mg for 25 days.
16161715|NCT01690286|Drug|JNJ-38518168 10 mg|One oral daily dose of JNJ-38518168 10 mg for 25 days.
16161716|NCT01690286|Drug|Ketoconazole 200 mg|Oral doses of ketoconazole 200 mg every 12 hours, from Day 22 through Day 25.
16161717|NCT01690273|Other|mobility exercise|30 minutes, twice a week
16161718|NCT01690273|Other|mobility and elastic resistance exercise|30 minutes, twice a week each exercises group. (total 1 hour)
16161719|NCT01690260|Drug|Bone Morphogenetic Protein 2|12 mg recombinant BMP-2 combined with an injection of 1-2 g collagen type 1.
16161720|NCT01690260|Procedure|Autologous bone graft|Autologous bone graft in connection with bone docking operation.
16161721|NCT01690247|Drug|Conventional plus UC-MSC|Received conventional treatment and taken i.v., once per 4 week, at a dose of 1×106 UC-MSC/kg body weight for 12 weeks.
16161722|NCT01690247|Drug|Conventional plus placebo|Received conventional treatment and taken i.v., once per 4 week, at 50 ml saline for 12 weeks.
16161723|NCT01690234|Procedure|Multidisciplinary intervention|Early coordinated multidisciplinary intervention. Physiotherapist, chiropractor, rheumatologist, psychologist, occupational physician, ergonomist and social worker/case manager.
16161724|NCT01690234|Procedure|Usual care|Intervention from physiotherapist, chiropractor, rheumatologist and social worker.
16161725|NCT01690221|Drug|VEN 307|VEN307 applied three times a day, in and around the anus, for 28 days.
16161726|NCT01690221|Drug|Placebo|Placebo cream applied three times a day, in and around the anus, for 28 days.
16161816|NCT01689519|Drug|Cobimetinib|Cobimetinib supplied as tablets
16240544|NCT01081548|Drug|atorvastatin|20 mg
16161727|NCT01690208|Other|EMERALD|"Patients assigned to the EMERALD group will be followed up at a Diabetes Centre led by the nurses and supported by diabetologists, with a particular emphasis on individualizing HbA1c goals and selecting drugs based on clinical profiles to maximize benefits and minimize harm.
~These patients will also undergo an intensive 3 to 4 months empowerment program where patients within the same group, and therefore sharing similar profiles, will return to the centre monthly to undergo a 2-3 hour activity session led by diabetes nurses, peer supporters and paramedics. Between medical visits, the nurses or HCA will telephone the patients at least once to provide support, help problem-shoot and remind them of their follow-up schedule."
16161728|NCT01690208|Other|Usual Care|Patients randomised to the usual care group will receive their routine care after the initial baseline comprehensive assessment & explanation of the JADE reports. A repeat comprehensive assessment will then be conducted at year 3.
16161729|NCT01690195|Drug|ABT-126|See arm description
16161730|NCT01690182|Dietary Supplement|Study test meal 1|Volunteers will be fed with a high volume, high energy density test meal.
16161731|NCT01690182|Dietary Supplement|Study test meal 2|Volunteers will be fed with a high volume, low energy density test meal
16161732|NCT01690182|Dietary Supplement|Study test meal 3|Volunteers will be fed with a low volume, high energy density test meal
16161733|NCT01690169|Drug|NNC0113-0987|A single dose for oral administration, up to 7 dose levels will be investigated. If a non-tolerated dose level has been reached, the dose level will not be increased further.
16161734|NCT01690169|Drug|placebo|A single dose of oral placebo administered.
16161735|NCT01690143|Drug|Carfilzomib|Subjects will receive the appropriate dose of carfilzomib (according to assigned cohort in phase 1 and at the determined MTD in phase 2) on days -3 and -2. Carfilzomib will be infused over 30 minutes. Prophylaxis of chemotherapy induced nausea and vomiting will follow institutional guidelines and SOPs.
16161736|NCT01690143|Drug|Melphalan|Subjects will receive 200 mg/m2 of intravenous melphalan on Day -2. Administered as an intravenous push or a fast infusion according to institutional standard operating procedure (SOP). Prophylaxis of chemotherapy induced nausea and vomiting will follow institutional guidelines and SOPs.
16161737|NCT01690130|Device|Transcranial Magnetic Stimulation (Neuronetics)|Transcranial magnetic stimulation is a noninvasive brain stimulation that can focally stimulate the brain of an awake individual. A TMS pulse focally stimulates the cortex by depolarizing superficial neurons which induces electrical currents in the brain.
16161738|NCT01690130|Device|Sham Transcranial Magnetic Stimulation|The electrical current of the sham system is titrated to a level matching participants' ratings of active TMS.The sham-TMS scalp discomfort will be matched to that of active TMS.
16161739|NCT01690117|Behavioral|GE-REACH-program|"The intervention program Resources to Enhance Alzheimer's Caregivers Health -second step (REACH II) is a multimodal, individualized and structured multi-component intervention program for family caregivers"
16161740|NCT01690104|Drug|Rifampicin|
16161741|NCT01690104|Drug|Placebo|
16161742|NCT01690091|Drug|Metformini hydrochloridum (Siofor 1000 tbl, Berlin)|"Patients will be randomized into 2 groups (A succession: MET-placebo, B succession: placebo-MET. After 3 months the treatment will be switched.
~Titration:
~500 mg per day(1/2 tbl 1000 mg once a day - in the morning) after a week increase the dose to 1 tbl á 1000 mg after two weeks increase the dose to 2 x tbl 1000 mg (in the morning and in the evening)"
16161743|NCT01690091|Drug|placebo|Patients will be randomized into 2 groups (A succession: MET-placebo, B succession: placebo-MET. After 3 months the treatment will be switched.
16161744|NCT01690065|Drug|Nilotinib+AD induction|"• Post-remission consolidation chemotherapy
~4 courses of high-dose cytarabine will be given as post-remission therapy. Cytarabine 3 g/m2 will be administered in a 3-hour iv infusion every 12 hours on days 1, 3, and 5 (a total of six doses per course).
~Nilotinib 400mg bid PO will be administered continuously during consolidation chemotherapy and for 2 years after the consolidation therapy or until allogeneic hematopoietic stem cell transplantation"
16161745|NCT01690052|Drug|Cevimeline|"Cevimlenine Vs Pilocarpine, cross over design. Two sequences were evaluated cevimeline first, then pilocarpine and pilocarpine first, then cevimeline. Each sequence was evaluated for 4 weeks with one week washout period in between both sequences. 15 patients were randomly assigned to a specific sequence by a research pharmacist independent from the study authors. The patients received 30mg of cevimeline three times a day and pilocarpine 5mg three times a day."
16161746|NCT01690052|Drug|Pilocarpine|Cevimlenine Vs Pilocarpine, cross over design, 4 weeks, one week wash out
16161747|NCT01690039|Drug|Furosemide-Fludrocortisone-Test (test for urinary acidification)|The presence of a lack of urinary acidification will be assessed by an appropriate test in all patients.
16161748|NCT01690026|Behavioral|Motivation interviewing based brief intervention|
16161749|NCT01690026|Behavioral|Standard Intervention|
16161750|NCT01690000|Drug|Melatonin|1 or 3 mg of melatonin PO each night for 12 months
16161751|NCT01689987|Drug|Cyclophosphamide|Given IV
16161752|NCT01689987|Drug|Dexamethasone|Given PO
16161753|NCT01689987|Drug|Hydroxychloroquine|Given PO
16161754|NCT01689987|Other|Laboratory Biomarker Analysis|Correlative studies
16161755|NCT01689987|Other|Pharmacological Study|Correlative studies
16161756|NCT01689987|Drug|Sirolimus|Given PO
16161757|NCT01689974|Drug|Ipilimumab|Ipilimumab will be administered alone on day 4, 25, 46 and 67.
16161758|NCT01689974|Radiation|Radiation Therapy|Radiation is given over one week interval On the fourth day of radiation (day 4)Ipilimumab is administered and repeated on Days 25, 46 and 67.
16161759|NCT01689961|Behavioral|Structured + monitored nutrition and exercise intervention|The exercise intervention includes a custom-designed pregnancy-specific group walking class of 30-60 min. 1x/week and a prescribed at-home walking program for 10,000 steps/day. The nutrition intervention is a high protein (25% energy) low-fat dairy food plan designed to meet energy needs and with individualized counselling. The intervention will include 2 x/month weight monitoring and records of nutrition and activity to ensure adherence.
16161760|NCT01689948|Behavioral|Home rehabilitation therapy|12 sessions of home rehabilitation therapy
16161761|NCT01689935|Drug|20 % Aminolevulinic Acid|topical medication for ALA-PDT and i-PDT
16161762|NCT01689935|Device|Red light only|Red Light therapy
16161763|NCT01689935|Device|Blue light only|Blue light only
16161855|NCT01689207|Drug|Avibactam (AVI)|PART A: AVI IV infusion
16161764|NCT01689922|Other|AlterG|All patients will begin an early postoperative rehabilitation program and standard PT no later than 4 weeks following surgery and continue for at least 6 weeks. The duration of standard PT program could be extended depending on the patient needs. The patients randomized to undergo (LBPP) treadmill training will have an additional 7-week 3 times a week training on the antigravity
16161765|NCT01689909|Drug|Zolpidem-CR|Zolpidem 6.25 mg or 12.5 mg in tablet form at nighttime 15 minutes before bed for 8 weeks
16161766|NCT01689909|Drug|Placebo|Placebo in tablet form at nighttime 15 minutes before bed for 8 weeks
16161767|NCT01689896|Drug|Testosterone Gel|
16161768|NCT01689896|Drug|Placebo Gel|
16161769|NCT01689883|Device|Current stimulator|This is a device developed by the investigators to produce sub-sensory electrical stimulation delivered via subcutaneous electrodes placed on the skin.
16161770|NCT01689870|Drug|Anti-OX40|Anti-OX40 will be administered i.v. over 60 minutes only in the first week on Days 1, 3 and 5
16161771|NCT01689870|Drug|Ipilimumab|Ipilimumab will be administered at 3 mg/kg i.v. over 90 minutes every 3 weeks for a total of 4 doses, starting on Day 1
16161772|NCT01689857|Device|Scarclinic™ Thin|Apply Scarclinic™ Thin on the scar and dispense 4 ea.for each participant for 3 month.
16161773|NCT01689857|Device|Scarclinic™ Normal|Apply Scarclinic™ Normal on the scar and dispense 4 ea.for each participant for 3 month.
16161774|NCT01689844|Behavioral|DASH Plus|DASH diet advice and guided shopping for high postassium foods at a local supermarket
16161775|NCT01689844|Behavioral|DASH - C|Brief DASH dietary advice, No shopping guidance at the local supermarket.
16161776|NCT01689831|Biological|To confirm the potency of Aplisol formulated with newly produced Tuberculin PPD compared to PPD-S2 standard.|Comparison of different dosages of Aplisol PPD relative to reference standard PPD-S2.
16161777|NCT01689831|Biological|Reactivity of Aplisol compared to reference standard PPD-S2.|Reference standard PPD-S2 formulated to contain different dose concentrations.
16161778|NCT01689818|Other|exercise training|exercise training program which included aerobic exercise for 3 times per week.
16161779|NCT01689792|Drug|MOVIPREP|
16161780|NCT01689792|Drug|CitraFleet|
16161781|NCT01689779|Drug|100,000 IU cholecalciferol|active drug
16161782|NCT01689779|Drug|Placebo|comparator drug
16161783|NCT01689766|Drug|Technetium Tc 99m EC20|
16161784|NCT01689753|Device|TEGO connector®|
16161785|NCT01689753|Drug|Trisodium citrate|
16161786|NCT01689740|Drug|Active Placebo Dose MDMA (25 mg)|Initial dose of 25 mg MDMA administered orally at the start of each of two psychotherapy sessions, possibly followed by a supplemental dose of 12.5 mg MDMA 1.5 to 2.5 hours later.
16161787|NCT01689740|Drug|Full Dose MDMA (125 mg)|Initial dose of 125 mg MDMA administered orally at the start of each of two psychotherapy sessions, possibly followed by a supplemental dose of 62.5 mg MDMA 1.5 to 2.5 hours later.
16161788|NCT01689740|Drug|Open Label Full Dose MDMA (125 mg)|Initial dose of 125 mg MDMA administered orally at the start of each of two psychotherapy sessions, possibly followed by a supplemental dose of 62.5 mg MDMA 1.5 to 2.5 hours later.
16161789|NCT01689740|Behavioral|Psychotherapy|Non-directive psychotherapy will be conducted throughout the study.
16161790|NCT01689727|Drug|Technetium Tc 99m EC20|
16161791|NCT01689714|Drug|Tc 99m EC20|
16161792|NCT01689701|Dietary Supplement|Hizikia Fusiformis extract|Hizikia Fusiformis extract(1.3g/d)
16161793|NCT01689701|Dietary Supplement|Placebo|Placebo(1.3g/d)
16161794|NCT01689675|Behavioral|Computer based pain management|
16161795|NCT01689662|Drug|Tc 99m EC20|
16161796|NCT01689649|Drug|Topiramate|The patients will receive topiramate tablet twice daily orally up to 16 weeks.
16161797|NCT01689636|Drug|Tc 99m EC20|
16161798|NCT01689623|Drug|TMC435|Type=exact number, unit=mg, number=150, form=capsule, route=oral. TMC435 will be administered at a dose of 150 mg once daily from Day 4 until Day 15.
16161799|NCT01689623|Drug|Atorvastatin|Type=exact number, unit=mg, number=40, form=tablet, route=oral. Atorvastatin will be administered as a single oral 40-mg dose on Day 1 and Day 13.
16161800|NCT01689623|Drug|Simvastatin|Type=exact number, unit=mg, number=40, form=tablet, route=oral. Simvastatin will be administered as a single oral 40-mg on Day 1 and Day 13.
16161801|NCT01689597|Drug|Morphine|Comparison of different dosages of drug
16161802|NCT01689597|Drug|Placebo|
16161803|NCT01689584|Genetic|salivary kit|The saliva samples will be made of selected related (DNA).
16161804|NCT01689571|Drug|CHF6001|
16161805|NCT01689571|Drug|Placebo|
16161806|NCT01689558|Drug|Recombine Endostatin|Recombine Endostatin is involved in the arm of Recombine Endostatin .Recombinant human vascular endothelial inhibin 7.5 mg/M2 / d dose add 250 ml of physiological saline, dilute in new adjuvant chemotherapy began to 8-21 days intravenous drip, at least 1 hour, a total of 1 cycle; The chemoradiation in cisplatin chemotherapy first day grace degrees 7.5 mg/M2 / d, 1-14 days, a total of one period of treatment
16161807|NCT01689545|Behavioral|Individual level|Index participants will participate in standard HIV VCT supplemented with 2 posttest counseling sessions, followed by 2 post-test skill-building support groups for HIV positive IDUs.
16161808|NCT01689545|Behavioral|Structural level|Community members will participate in 2 community-based HIV and IDU stigma videos combined with a series of visits with community outreach workers.
16161809|NCT01689545|Behavioral|Individual level standard of care|The education materials that are currently offered in Thai Nguyen will be delivered didactically by health workers on 1) the HIV situation in Vietnam; 2) consequences of drug use; 3) routes of HIV transmission; and 4) options for drug treatment.
16161810|NCT01689545|Behavioral|Structural level standard of care|Posters and billboards on HIV/AIDS transmission, leaflets on HIV/AIDS transmission available in health station, 15-minute monthly public broadcasts (via the village loudspeaker) on the consequences of HIV/AIDS and the number of HIV cases in the country and province will be delivered in communities.
16161811|NCT01689532|Drug|Sirukumab 100 mg|Sirukumab 100 mg subcutaneous (SC) injection, at Weeks 0, 2, and every 2 weeks through Week 52.
16161812|NCT01689532|Drug|Sirukumab 50 mg|Sirukumab 50 mg SC at Weeks 0, 4, and every 4 weeks through Week 52.
16161813|NCT01689532|Drug|Placebo|Between sirukumab injections, placebo SC at Weeks 2, 6, and every 4 weeks through Week 52.
16161814|NCT01689519|Drug|Placebo|Placebo supplied as tablets
16161817|NCT01689506|Drug|Volulyte|6 % hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution will be intravenously infused in order to achieve and maintain predefined hemodynamics goals and may be given up to a total daily dose of 50 mL/kg body weight/day.
16161818|NCT01689506|Drug|Human Serum Albumin|5% Human Serum Albumin will be intravenously infused in order to achieve and maintain predefined hemodynamics goals with no daily dose limit.
16161819|NCT01689493|Behavioral|patient education and daily SMS|The proposed intervention will be based on several conceptual frameworks (Chronic Care Model and Medication Adherence Model) and adapt elements of prior successfully adherence interventions, including: collaborative care, patient education, tailoring of medication regimens, and daily mobile phone short message service (SMS).
16161820|NCT01689480|Other|FSHD training|The training will consist in 3 sessions of 35 min of training per week at home on an ergocycle. The training will be divided in (i) 2 sessions of 30 min aerobic exercises at a constant but moderate (60% of maximal aerobic power, MAP) intensity followed with 5 sets of 10 revolutions at near-maximal intensity and (ii) an interval-training session. This latter session will consist in 5 min warm-up at 40% MAP followed by 5 times 1 min at 80% MAP (recovery = 4 min at 40% MAP) followed by 5 min of active recovery. A systematic supervision of the sessions by the coach will be performed by phone, by using the heart rate recordings and values of Analogic Visual Scale for pain and fatigue.
16161821|NCT01689467|Dietary Supplement|Fermented Velvet Antler extract|Fermented Velvet Antler extract (1g/day)
16161822|NCT01689467|Dietary Supplement|Placebo|Placebo (1g/day)
16161823|NCT01689441|Drug|Calcitriol|
16161824|NCT01689441|Drug|Placebo|
16161825|NCT01689402|Device|MRI Scan with the specified sequences below:|"Standard sequences: Axial T2, axial DWI, Sagittal T1, T2 flair og axial GRE-sequence.
~Susceptibility weighted imaging (SWI)
~Chemical Shift Imaging (CSI) multivoxel spectroscopi
~Post contrast 3D box reconstruction"
16161826|NCT01689376|Drug|Regorafenib (BAY73-4506)|160 mg BAY73-4506, 3 weeks on drug, 1 week off drug
16161827|NCT01689363|Drug|Hyaluronidase|Subjects received intradermal injections of 0.02 mL Amphadase® (hyaluronidase 150 USP units/mL) at two random sites on their forearms.
16161828|NCT01689363|Drug|Histamine|Subjects received one intradermal injection of 0.02 mL Histatrol® (histamine base 0.1 mg/mL) at one random sites on their forearms.
16161829|NCT01689363|Drug|Saline|Subjects received one intradermal injection of 0.02 mL saline at one random site on their forearm.
16161830|NCT01689350|Genetic|Genotype Detection|To Genotype cases in the experimental group and divide them into three groups, including extensive metaboliser (EM), intermediate metaboliser (IM) and poor metaboliser (PM).
16161831|NCT01689337|Drug|Sprifermin (AS902330)|Sprifermin (AS902330) will be administered at a dose of 30 microgram (mcg) as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
16161832|NCT01689337|Drug|Sprifermin (AS902330)|Sprifermin (AS902330) will be administered at a dose of 100 mcg as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
16161833|NCT01689337|Drug|Placebo|Placebo matched to Sprifermin (AS902330) will be administered as intra-articular injection once every week for 3 weeks, starting from 2 weeks after MFx surgery.
16161834|NCT01689324|Biological|(ADACEL®): Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis|0.5 mL, Intramuscular
16161835|NCT01689311|Drug|Oxytocin|Oxytocin, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
16161836|NCT01689311|Drug|Ergonovine|Ergonovine, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
16161837|NCT01689311|Drug|Prostaglandin F2alpha|Prostaglandin F2alpha, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
16161838|NCT01689311|Drug|Misoprostol|Misoprostol, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
16161839|NCT01689298|Drug|Oxytocin|Oxytocin, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
16161840|NCT01689298|Drug|Carbetocin|Carbetocin, 10-10mol/L to 10-5mol/L; solution made in double-distilled autoclaved water and then tested in physiological salt solution.
16161841|NCT01689285|Drug|valacyclovir tablet|16 healthy adult volunteers (18-55 yr) will be exposed to one tablet
16161842|NCT01689285|Drug|valacyclovir oral solution|16 healthy adult volunteers (18-55 yr) will be exposed to 10 ml once
16161843|NCT01689272|Procedure|Kidney Transplantation from alive relative donor|Donor kidney sampling, preservation, transport and transplantation
16161844|NCT01689259|Drug|SL TNX-102 at 2.4 mg|1 TNX-102 SL Tablet at 2.4 mg held under the tongue until dissolution, without swallowing or chewing it.
16161845|NCT01689259|Drug|SL TNX-102 at 4.8 mg|2 TNX-102 SL Tablet at 2.4 mg held under the tongue until dissolution, without swallowing or chewing them.
16161846|NCT01689259|Drug|SL TNX-102-A at 2.4 mg|1 TNX-102-A SL Tablet at 2.4 mg held under the tongue until dissolution, without swallowing or chewing it.
16161847|NCT01689259|Drug|Cyclobenzaprine tablets|1 x 5 mg cyclobenzaprine tablet, swallowed with 240 mL of room-temperature water
16161848|NCT01689246|Drug|TRx0237 150 mg/day|TRx0237 75 mg tablets will be administered twice daily.
16161849|NCT01689246|Drug|TRx0237 250 mg/day|TRx0237 125 mg tablets will be administered twice daily.
16161850|NCT01689246|Drug|Placebo|Placebo tablets will be administered twice daily. The active placebo tablets include 4 mg of TRx0237 as a urinary and fecal colorant to maintain blinding; hence the placebo group will receive a total of 8 mg/day of TRx0237.
16161851|NCT01689233|Drug|TRx0237 200 mg/day|TRx0237 100 mg tablets will be administered twice daily.
16161852|NCT01689233|Drug|Placebo|Placebo tablets will be administered twice daily. The active placebo tablets include 4 mg of TRx0237 as a urinary and fecal colorant to maintain blinding; hence the placebo group will receive a total of 8 mg/day of TRx0237.
16161853|NCT01689220|Drug|SP-02L (darinaparsin for injection)|Cohort 1: Darinaparsin 300 mg/m2 for 5 consecutive days every 28 days (5 days therapy, 23 days no therapy is one cycle). Subjects may start from Cycle 1 and continue to a maximum of 4 cycles of treatment.
16161854|NCT01689220|Drug|SP-02L (darinaparsin for injection)|Cohort 2: Darinaparsin 300 mg/m2 for 5 consecutive days every 21 days (5 days therapy, 16 days no therapy is one cycle). Subjects may start from Cycle 1 and continue to a maximum of 4 cycles of treatment.
16161856|NCT01689207|Drug|Aztreonam (ATM)|PART A: ATM IV infusion
16161857|NCT01689207|Drug|combination of Aztreonam - Avibactam (ATM-AVI)|PART A: ATM-AVI IV infusion. PART B and C: ATM-AVI IV infusions.
16161858|NCT01689207|Drug|Placebo|PART A, PART B, PART C: matching placebo IV infusions
16161859|NCT01689194|Drug|genexolPM + cisplatin|
16161860|NCT01689168|Behavioral|Counseling|Tobacco cessation counseling
16161861|NCT01689168|Procedure|Chiropractic adjustment|Full spine high velocity, low amplitude manipulation of the spine
16161862|NCT01689155|Biological|Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, Intramuscular
16161863|NCT01689142|Drug|Insulin glargine new formulation (HOE901)|Pharmaceutical form: solution Route of administration: subcutaneous
16161864|NCT01689142|Drug|Insulin glargine (HOE901)|Pharmaceutical form: solution Route of administration: subcutaneous
16161865|NCT01689129|Drug|Insulin glargine new formulation (HOE901)|Pharmaceutical form: solution Route of administration: subcutaneous
16161866|NCT01689129|Drug|Insulin glargine (HOE901) (Lantus)|Pharmaceutical form: solution Route of administration: subcutaneous
16161867|NCT01689116|Drug|Bardoxolone Methyl 20mg|Oral
16161868|NCT01689116|Drug|Bardoxolone Methyl 80mg|Oral
16161869|NCT01689116|Drug|Bardoxolone Methyl Placebo|Oral
16161870|NCT01689116|Drug|Moxifloxacin 400mg|Oral
16161871|NCT01689116|Drug|Moxifloxacin Placebo|Oral
16161872|NCT01689103|Behavioral|Cognitive-behavioral treatment|Cognitive-behavioral treatment of alcohol use disorders
16161873|NCT01689103|Behavioral|Cognitive-behavioral treatment|Cognitive-behavioral treatment for alcohol use disorders
16161874|NCT01689090|Other|COX inhibitor|Administration of 1 drop voltaren 45 minutes before recordings of diameter changes of retinal vessels are initiated
16161875|NCT01689090|Other|L-NG-monomethyl arginine citrate|Intravenous administration of L-NMMA during recordings of diameter changes of retinal vessels
16161876|NCT01689090|Other|COX inhibitor + L-NG-monomethyl arginine citrate|Combination of interventions. Administration of an eye drop voltaren and 45 minutes later infusion with L-NMMA is started and recording of diameter changes of retinal vessels is performed
16161877|NCT01689077|Other|Therapeutic hypothermia|Mild therapeutic hypothermia with a target temperature of 33 degrees Centigrade for 24 or 48 hours
16161878|NCT01689064|Procedure|Stamm Approach|
16161879|NCT01689064|Procedure|Posterior Septectomy|
16161880|NCT01689051|Other|human glucagon-like peptide 1 (7-36)amide|
16161881|NCT01689051|Other|human glucagon-like peptide 1 (9-36)amide|
16161882|NCT01689038|Drug|F17464|Single dose
16161883|NCT01689025|Drug|NNC0114-0006|Administered subcutaneously (s.c., under the skin) every second week to a total of four doses.
16161884|NCT01689025|Drug|placebo|Administered subcutaneously (s.c., under the skin) every second week to a total of four doses.
16161885|NCT01689012|Behavioral|Facial Exercise|
16161886|NCT01688999|Drug|Cabozantinib|60 mg by mouth (PO) daily each 28 day cycle. Treatment continues until toxicity or disease progression.
16161887|NCT01688973|Drug|Erlotinib Hydrochloride|150 mg (1 tablet) by mouth on days 1-28, once daily, until disease progression
16161888|NCT01688973|Other|Laboratory Biomarker Analysis|Correlative studies
16161889|NCT01688973|Drug|Tivantinib|360 mg (3 tablets) by mouth, Twice daily (720 mg total daily dose) on days 1-28, until disease progression
16161890|NCT01688960|Drug|nesvacumab (REGN910/ SAR307746)|Dose level 1
16161891|NCT01688960|Drug|nesvacumab (REGN910/ SAR307746)|Dose level 2
16161892|NCT01688960|Drug|nesvacumab (REGN910/ SAR307746)|Dose level 3
16161893|NCT01688960|Drug|aflibercept (ziv-aflibercept)|Dose level 1
16161894|NCT01688960|Drug|aflibercept (ziv-aflibercept)|Dose level 2
16161895|NCT01688947|Drug|V116517 50-mg tablets|Taken orally twice daily
16161896|NCT01688947|Drug|V116517 30-mg tablets|Taken orally twice daily
16161897|NCT01688947|Drug|Pregabalin capsules|1-2 capsules taken orally twice daily
16161898|NCT01688947|Drug|Placebo|Tablets to match V116517 taken orally twice daily and/or placebo capsules to match pregabalin, 1-2 capsules taken orally twice daily
16161899|NCT01688934|Drug|V116517 50-mg tablets|Taken orally twice daily
16161900|NCT01688934|Drug|V116517 30-mg tablets|Taken orally twice daily
16161901|NCT01688934|Drug|Naproxen 500-mg capsules|Taken orally twice daily
16161902|NCT01688934|Drug|Placebo|Tablets to match V116517 and/or placebo capsules to match naproxen taken orally twice daily
16161903|NCT01688921|Biological|AFLURIA vaccine (2012-2013 formulation)|Patients will receive a single 0.5 mL injection of AFLURIA vaccine in the deltoid region.
16161904|NCT01688921|Device|Needle-Syringe|
16161905|NCT01688921|Device|Stratis needle-free injection device|
16161906|NCT01688908|Procedure|Endoscopic Screening|"Upper G.I. endoscopic examination with Lugols Iodine in esophagus
~Biopsy at the visually abnormal sites
~Pathologic examination of all biopsy tissue specimens
~Subsequent re-examination and further medical services among individuals who already have high-grade lesions found at screening.
~Advises of endoscopic or surgical treatment will be given to participants who are diagnosed of high grade upper G.I. lesions."
16161907|NCT01688882|Drug|QGE031|QGE031 will be evaluated at various dose levels and regimens, based on the impact on disease of the next highest dose level and regimen.
16161908|NCT01688882|Drug|Placebo|Placebo will be used to control for normal variability in disease severity.
16161909|NCT01688856|Device|Electrical Stimulator|"The 12-week treatment period consists of two components:
~Therapist-guided task practice performed 70 minutes twice a week in the research laboratory. If Arm+Hand CCFES or Hand CCFES, the stimulator is used during task practice.
~Self-administered muscle stimulation exercise performed 10 sessions per week at home using the device. If Arm+Hand CCFES or Hand CCFES, each session is 46 minutes. If Arm+Hand Cyclic NMES, each session is 60 minutes."
16161910|NCT01688843|Device|INGEVITY lead|
16161911|NCT01688830|Drug|Dabigatran|
16161912|NCT01688830|Drug|BI 655075|
16161913|NCT01688830|Drug|Placebo|
16161955|NCT01688466|Drug|Pomalidomide|0.5 mg/day with and/or without Dose Escalation and 0.5 mg/day- 2.0 mg/day by mouth (PO) QD(every day) of each 28 day cycle
16162066|NCT01687478|Drug|Olanzapine|Administered Orally
16241673|NCT01072214|Drug|pazopanib|gw786034
16161914|NCT01688817|Other|Physician's counseling|Colorectal cancer (CRC) screening was recommended to a patient personally by a PCP. The issue was discussed during a routine medical visit according to a standardized scheme. PCP provided a patient with a rationale for CRC screening in asymptomatic individuals and benefits of early treatment of the disease. A patient was told about colonoscopy-based screening program. A PCP provided patient with information on how colonoscopy is performed and how to prepare a bowel for the examination, and informed a patient about possible adverse events related to the procedure including post-polypectomy bleeding and bowel perforation. According to the scheme of the discussion screening modalities other than colonoscopy were not debated, unless a patient specifically asked about them.
16161915|NCT01688817|Other|Information leaflet|Patients were given leaflet on primary colonoscopy colorectal cancer screening program. A leaflet provided rationale for colorectal cancer screening and information on colonoscopy-based colorectal cancer screening program.
16161916|NCT01688804|Behavioral|Behavioral intervention to reduce sedentary time delivered via mobile smartphone|The overall goals of the intervention are to decrease overall sedentary time and to increase the number of breaks in sedentary time. The intervention approach combines an advanced smartphone device with an on-board accelerometer and a sophisticated smartphone application to: 1) monitor participants sedentary behavior in real time in their natural environment; and 2) use monitored data to deliver immediate, individually-tailored, goal-driven prompts and feedback to encourage substitute of sedentary behaviors with physical activity.
16161917|NCT01688791|Drug|Vintafolide|
16161918|NCT01688791|Drug|Carboplatin|
16161919|NCT01688791|Drug|Paclitaxel|
16161920|NCT01688778|Behavioral|Telemedicine|"Monthly video consultations with a nurse as add-on to standard treatment. The nurse has access to bloodsugar- bloodpressure and weight measurements uploaded by the participants to a tablet computer directly from the devices.
~Patients on Insulin measure bloodsugar twice a day (fasting and before their evening meal). Patients not on Insulin measure bloodsugar once a week (fasting and before their evening meal). All participants measure bloodpressure and weight once a week. The intervention lasts 32 weeks."
16161921|NCT01688739|Drug|Erenumab|Administered by subcutaneous injection or intravenous injection
16161922|NCT01688739|Drug|Placebo|Administered by subcutaneous injection or intravenous injection
16161923|NCT01688726|Other|SYSTANE® BALANCE eyedrops|
16161924|NCT01688726|Other|Minims® Saline 0.9% eyedrops|
16161925|NCT01688713|Drug|Icotinib|The patients will receive Icotinib in doses of 250mg thrice per day until disease progression or undue toxicity.
16161926|NCT01688700|Drug|Nimotuzumab combined with paclitaxel and cisplatin|"Nimotuzumab: 200mg, IV once a week for 6 weeks during chemotherapy (days 1,8,15,22,29,36).
~Cisplatin: 75mg/m2,IV on days 1，22
~paclitaxel: 90mg/m2, IV on days 1,8,22,29.
~patients will receive radical operation 4-6 weeks after Neoadjuvant therapy."
16161927|NCT01688687|Procedure|Endoscopic submucosal dissection|
16161928|NCT01688674|Drug|10% dextrose|
16161929|NCT01688648|Drug|Lidocaine infusion|a bolus dose of Lidocaine 1.5 mg/kg after anesthetic induction with following infusion with 2 mg/kg/hr during the surgery and same dose during postoperative 24 hour in ICU.
16161930|NCT01688648|Drug|Dexmedetomidine infusion|Dexmedetomidine infusion during anesthetic induction with 0.2 mcg/kg/hr followed by 0.3 ~ 0.7 mcg/kg/hr during the surgery
16161931|NCT01688635|Drug|LY2963016|Administered subcutaneously
16161932|NCT01688635|Drug|US Approved Lantus|Administered subcutaneously
16161933|NCT01688622|Behavioral|3months Exercise|training session consisting of a brief warm-up, followed by an approximately 45-min session of aerobic exercise at an intensity of 60-75% of the age-predicted maximum heart rate (approximately 300 kcal/day) and a 20-min muscle strength train- ing programme (approximately 100 kcal/day), followed by a brief cool-down period.
16161934|NCT01688609|Drug|lapatinib ditosylate|Given PO
16161935|NCT01688609|Drug|paclitaxel|Given IV
16161936|NCT01688609|Biological|trastuzumab|Given IV
16161937|NCT01688609|Procedure|therapeutic conventional surgery|Undergo lumpectomy or mastectomy
16161938|NCT01688609|Other|pharmacological study|Correlative studies
16161939|NCT01688609|Other|laboratory biomarker analysis|Correlative studies
16161940|NCT01688596|Drug|Bupivacaine|Bupivacaine (0.25%) will be injected through the closed trocar incisions after completion of the laparoscopic hysterectomy case.
16161941|NCT01688583|Drug|Fentanyl matrix|Dose will be adjusted in accordance with patient's degree of pain and treatment response in the investigator's judgment.
16161942|NCT01688570|Drug|duloxetine|Single dose, orally (pill), 30 mg, taken 6 hours prior to start of the testing session. Subjects will only take a single dose of duloxetine once.
16161943|NCT01688570|Drug|Cyproheptadine|Single dose, orally, 8 mg, 6 hours prior to the start of the respective testing session. Subjects will take a single dose of cyproheptadine once.
16161944|NCT01688570|Drug|Placebo|Single dose, orally, 6 hours prior to the start of the respective testing session. Subjects take a single dose once.
16161945|NCT01688557|Device|Innovative colonoscopy (Olympus CF-HQ190F, NBI + Dual Focus)|NBI and Dual Focus options will be used to classify lesions according to Sano and Kudo classifications.
16161946|NCT01688557|Device|Conventional colonoscopy (Olympus CF-H180DL)|Conventional colonoscopy performed without innovative techniques used in experimental arm.
16161947|NCT01688544|Drug|Ilaprazole|Ilaprazole 10 mg for 7 days
16161948|NCT01688531|Drug|CD0271 0.1%/CD1579 2.5% gel|one application (pea-sized amount according to the labelling) on a half-face, 5 to 7 days for 6 months
16161949|NCT01688531|Drug|CD0271 0.1%/CD1579 2.5% gel vehicle|one application (pea-sized amount according to the labelling) on a half-face, 5 to 7 days for 6 months
16161950|NCT01688518|Drug|Heated Lidocaine/Tetracaine Patch|
16161951|NCT01688518|Drug|5% Lidocaine Patch|
16161952|NCT01688492|Drug|Ipilimumab|Abiraterone acetate (JanssenBiotech, Inc/Johnson & Johnson) 1000 mg orally daily plus prednisone 5 mg orally twice daily will be administered continuously during the duration of the trial. Starting at cycle 3 (Combination Therapy), Ipilimumab (Bristol-Myers Squibb) will be infused intravenously (IV) once every 3 weeks for a total of 4 infusions.
16161953|NCT01688479|Drug|Calendula Weleda cream (Weleda AG, Sweden) contains extracts of marigold plant (Calendula Officinalis 10%), wool fat and sesame oil|
16161954|NCT01688479|Drug|Essex® cream (Schering-Plough), aqueous cream without parabens|
16161977|NCT01688258|Procedure|Diagnostic swab|
16161956|NCT01688453|Behavioral|Standard care management|The standard-care management program consists of 5 collective sessions of 2 hr each about nutritional practices (food and physical activity) and on changes of nutritional behaviours. The sessions are organized in high schools by the healthcare team in collaboration with pediatricians, dietitians and the Sickness Insurance Primary Fund.
16161957|NCT01688453|Behavioral|The strengthened care management|"The strengthened care management is the addition of the standard care management and of additional interventions.
~The standard-care management program consists of 5 collective sessions of 2 hr each about nutritional practices (food and physical activity) and on changes of nutritional behaviours. The sessions are organized in high schools by the healthcare team in collaboration with pediatricians, dietitians and the Sickness Insurance Primary Fund.
~The additional interventions are strengthened solicitation and accompaniment, peer-led education, motivational interview, financial support for physical activity practice, cooking classes and meetings of multidisciplinary consultation."
16161958|NCT01688440|Other|#1 Respiratory Care Solution|Respiratory care solution.
16161959|NCT01688427|Behavioral|Standard IPV Assessment|Test the effectiveness of the eMOCHA DOVE application using mHealth technology for routine assessment of IPV vs. Pencil and paper at enrollment, delivery, and 2 months post birth.
16161960|NCT01688427|Behavioral|Standard DOVE Intervention|Intervention will be administered via eMOCHA tablet vs. home visitor over 6 sessions in 6 months.
16161961|NCT01688414|Procedure|photoacoustic imaging|Undergo PAI
16161962|NCT01688414|Procedure|fluorescence imaging|Undergo fluorescence imaging
16161963|NCT01688414|Procedure|robot-assisted laparoscopic surgery|Undergo robot-assisted laparoscopic surgery
16161964|NCT01688401|Drug|Melphalan hydrochloride|"Drug administered intra-arterially (injection in the artery).
~Standard dose: Cycle 1: 1 mg, intra-arterial (IA) delivery. Cycle 2: 2 mg, intra-arterial (IA) delivery.
~Duration of treatment: Eight weeks total - two cycles of IA chemotherapy, separated by four weeks."
16161965|NCT01688388|Procedure|Intraoperative Radiotherapy|Intraoperative radiotherapy (IORT) is delivered after completion of the lumpectomy and sentinel node procedure. IORT is performed on mobile or fixed linacs with variable electron energies in the range of 6-12 MeV prescribed to a dose of 21 Gy, with the prescription dose covering at least 90% of the Planning Target Volume (PTV). PTV is defined as a 3D volume of 1-2 cm beyond the former macroscopic tumor edge (excluding skin, limit to anterior rib surface: 5 Gy). The choice of electron energy as well as the cone applicator size has to account for minimum PTV requirements. Tissue depth measurement will be documented by intraoperative sonography.
16161966|NCT01688375|Drug|Ursodeoxycholic Acid|UDCA administration will begin twenty-four hours after endoscopic or surgical procedure and will last fourteen days. UDCA dose will be administered at 750 mg/day, divided into three doses.
16161967|NCT01688362|Biological|Platelet Rich Plasma (PRP)|Subjects in this group will receive 2 injections with PRP. Subjects will have will have 15cc of blood drawn with the Arthrex ACP syringe. The blood will be placed into the Arthrex PRP centrifuge and spun at 1500 rpms for 5 minutes. The platelets will be drawn off to create the PRP for injection. A posterior glenohumeral injection under ultrasound guidance will be performed to inject the PRP solution using a 22g needle. A dry sterile dressing will be placed on the injection site. This injection will Take place at time zero and then two weeks later it will be repeated.
16161968|NCT01688362|Drug|Corticosteroid|"Subjects in this group will receive one injection with corticosteroids and then one injection with local anesthetic two weeks later. For the first injection patients will have 15ml of blood drawn. This blood will then be discarded in a biohazard container. A 6ml solution of 4ml 0.25% Bupivacaine, 1ml 40mg Kenalog, and 1ml 4mg Dexamethasone will be prepared. A posterior glenohumeral injection under ultrasound guidance will be performed to inject the steroid solution using a 22g needle. A dry sterile dressing will be placed at the injection site.
~For the second injection two weeks later patients will have 15 ml of blood drawn. This blood will then be discarded in a biohazard container. Using the same technique as in Visit 2, the investigator will inject a 6 ml solution of 2 ml sterile normal saline with 4 ml 0.25% Bupivacaine to the shoulder using ultrasound. A dry sterile dressing will be placed at the injection site."
16161969|NCT01688349|Other|analyze the role of glucocorticoid in AT distribution.|"The purpose of this trial is to investigate the impact of cortisol on adipose tissue functions, distribution and morphology. Patient with endogenous blood cortisol excess exhibit changes in adipose tissue, with fat gain in the upper trunk, face and neck leading to visceral obesity and features of the metabolic syndrome. The aims of this study will be
~to compare the pattern of gene expression between visceral and subcutaneous adipose tissue in Cushing patients requiring an adrenalectomy as cortisol adenoma treatment;
~to compare these patterns of gene expression with those of two control populations:1/ healthy metabolic subjects having a partial nephrectomy, 2/obese patients with similar degree of insulin resistance."
16161970|NCT01688336|Drug|FOLFIRINOX|"FOLFIRINOX will be given intravenously on Days 1, 15, and 28 of each 28 day cycle. Drugs are given in combination in this order:
~Oxaliplatin (85 mg/m2)
~Leucovorin (400mg/ m2)
~Irinotecan (180 mg/m2)
~5FU (400mg/m2)bolus then 2400 mg/m2 over 46 hours"
16161971|NCT01688323|Other|Collect Blood and Survey Instruments|Each subject will be administered the appropriate surveys and blood draws over the course of the study.
16161972|NCT01688310|Procedure|Gomco Clamp with Tissue Adhesive|"According to WHO (2011), the Gomco clamp has …an impeccable safety record. In the USA, where it is estimated that well over 1 million neonates are circumcised each year, the Gomco clamp has become the leading instrument used to perform non-ritual male circumcision. Tissue adhesive is widely used in multiple areas of medicine; specifically, multiple observational studies and RCTs have shown cyanoacrylate tissue adhesives to be superior to suture closure in VMMC."
16161973|NCT01688310|Procedure|Open surgical circumcision|The World Health Organization, in its Manual for Male Circumcision under Local Anaesthesia, describes three open surgical techniques (forceps assisted, dorsal slit and sleeve technique), all three of which involve (a) exposure of subcutaneous tissues and (b) suturing for hemostasis and for skin closure.
16161974|NCT01688297|Biological|VXA-A1.1 Oral Vaccine|One or two doses of replication incompetent adenovirus oral tablet vaccine
16161975|NCT01688297|Biological|VXA Placebo Tablet|Off-white tablets similarly formulated to the active drug product tablets.
16161976|NCT01688284|Device|office hysteroscopy|Endometrial wash and biopsy is taken at the day around implantation window (day 14_to day 22)of the menstrual cycle from patients of recurrent miscarriages to evaluate the levels of uterine natural killer cells compared to control of females of normal reproductive outcome
16161978|NCT01688245|Behavioral|SMS Assessments & Feedback|Weekly pre-weekend drinking plan and post-weekend drinking outcome assessments with personlaized feedback
16161979|NCT01688245|Behavioral|SMS Assessments|Weekly post-weekend drinking outcome assessments
16161980|NCT01688206|Biological|Atezolizumab [TECENTRIQ]|Participants will receive atezolizumab at a fixed dose of 840 mg, intravenously every 2 weeks.
16161981|NCT01688206|Biological|Vanucizumab|Participants will receive escalating doses of vanucizumab (starting dose: 3 milligram [mg] per kilogram) and fixed dose of vanucizumab (MTD/RP2D: 30 mg/kg), intravenously every 2 weeks.
16161982|NCT01688167|Behavioral|MC and sexual risk reduction|Four group counselling sessions focused on male circumcision and sexual risk reduction
16161983|NCT01688154|Dietary Supplement|35 mg/Kg of grape seed proanthocyanidins extract (2 capsules)|
16161984|NCT01688154|Other|2 empty capsules|
16161985|NCT01688141|Other|Enhanced management|Specialist nurses providing enhanced CKD management using NICE guidelines and enhanced access to secondary care.
16161986|NCT01688128|Device|Phase I U-SMART (4 wks)|Intervention_Control Group, 4-weeks U-SMART(2 session/week); Control_Intervention Group, no intervention
16161987|NCT01688128|Other|Washout (2 wks)|2-weeks wash out period in both arms
16161988|NCT01688128|Device|Phase II U-SMART (4 wks)|Intervention_Control Group, no intervention; Control_Intervention Group, 4-weeks U-SMART(2 session/week, Crossover design)
16161989|NCT01688115|Procedure|Video|The afternoon before the surgery session, a researcher will show to the child a video of the length of 6 minutes, using an I-pad. The video shows two clown doctors working constantly at Meyer Children's Hospital, which, through skits and gags, will tell the child how is an operating room and some devices and procedures used during the induction of anesthesia.
16161990|NCT01688115|Other|Standard care|In this arm orally information will be given by the nurse of the ward only to the parents of the child. Any additional information or explanation will be given to the child
16161991|NCT01688102|Dietary Supplement|Oral Vitamin D3|50,000 units orally, each week x8 weeks; supplemental doses of 50,000 units orally, each month thereafter as needed
16161992|NCT01688102|Radiation|Ultraviolet Light|16 treatments, 2-3 times weekly over 8 weeks; initial dose 45-75 seconds, whole-body exposure except face and groin, increasing by 10% as tolerated, to a maximum of 4.5 minutes
16161993|NCT01688089|Drug|ODM103|
16161994|NCT01688089|Drug|Placebo|
16161995|NCT01688089|Drug|Entacapone|
16161996|NCT01688089|Drug|Levodopa/carbidopa|
16161997|NCT01688076|Procedure|Botulinum Toxin A|Forehead will be injected with Botox.
16161998|NCT01688050|Device|Zenith® TX2® Low Profile Endovascular Graft|Treatment of Blunt thoracic aortic injuries (BTAIs)
16161999|NCT01688037|Drug|NBI-98854|25 mg capsule
16162000|NCT01688037|Drug|NBI-98854|50 mg capsule
16162001|NCT01688037|Drug|Placebo|
16162002|NCT01688024|Drug|Mitomycin C|
16162003|NCT01688024|Drug|Normal saline|
16162004|NCT01687998|Drug|Evacetrapib|Administered Orally
16162005|NCT01687998|Drug|Placebo|Administered Orally
16162006|NCT01687985|Drug|BLI801 laxative - low dose|BLI801 laxative - oral solution
16162007|NCT01687985|Drug|BLI801 laxative - high dose|BLI801 laxative - oral solution
16162008|NCT01687972|Combination Product|Insorb absorbable staples|Placement of Insorb absorbable staples at cesarean section
16162009|NCT01687972|Combination Product|Absorbable sutures|placement of absorbable sutures at cesarean section
16162010|NCT01687959|Other|tissue sampling from peritoneum of the gallbladder|tissue sampling from peritoneum of the gallbladder during laparoscopic cholecystectomy after an acute attack of acute biliary pancreatitis
16162011|NCT01687933|Device|three-dimensional glasses(manufactor Vuzix,wrap 920)|The samples were randomly allocated to use three-dimensional glasses for 30 minutes in order to reliving labor pain.
16162012|NCT01687933|Other|usual care|Women in Control group did not use the glasses.
16162013|NCT01687920|Drug|BAY94-8862 (1.25mg)|
16162014|NCT01687920|Drug|BAY94-8862 (2.5mg)|
16162015|NCT01687920|Drug|BAY94-8862 (5mg)|
16162016|NCT01687920|Drug|BAY94-8862 (7.5mg)|
16162017|NCT01687920|Drug|BAY94-8862 (10mg)|
16162018|NCT01687907|Behavioral|Music|
16162019|NCT01687894|Drug|Vasopressins|Vasopressins propofol vasopressins sevoflurane
16162020|NCT01687894|Drug|Placebo|Placebo propofol & placebo sevoflurane
16162021|NCT01687894|Drug|propofol|vasopressin propofol & placebo propofol
16162022|NCT01687894|Drug|sevoflurane|vasopressins sevoflurane placebo sevoflurane
16162023|NCT01687881|Other|Chiropractic|Chiropractic Spinal Manipulative Therapy
16162024|NCT01687881|Other|Sham Chiropractic|Sham manipulation
16162025|NCT01687868|Drug|Dexmedetomidine|dexmedetomidine 0.7mcg/kg/hr continuous infusion
16162026|NCT01687855|Device|Ultrafast Magnetic Resonance Imaging|MRI was performed with a 1.5 superconducting magnet (Gyroscan Intera type, Philips Co. Holland) in a posterior and anterior neck coil. The sequence used to perform the ultrafast MRI was a fast gradient- echo plus sequence. Technical parameters included: echo time, 12 msec; repetition time, 2.3 msec; flap angle, 250; matrix, 192 × 512; section thickness, 7 mm. The imaging time per slice for this sequence was 0.92 sec. A total of 120 consecutive images were obtained as a single section, with a total imaging time of 110.4 seconds. MRI scanning was carried out with the subject first asleep, then whilst awake after 20 minutes in quiet respiration. All images were inputted to the PACS workstation.
16162027|NCT01687842|Other|Evaluation of 45,X Turner syndrome patients|Evaluation of 45,X Turner syndrome patients
16162028|NCT01687803|Behavioral|Physical Activity|Physical activity intervention that will consist of brisk walking or other aerobic-type activities (6 days per week), resistance exercise (using free weights, resistance bands or weight stacks for weight lifting, 3 days per week), and 'active lifestyle' activities such as gardening, dancing, participation in sporting activities. The total time spent in these activities will add up to ~60 min/day for 6 days/week (~360 minutes per week).
16162029|NCT01687803|Behavioral|Control|The control group will maintain their usual level of physical activity and participate in testing protocols, record keeping, and interviews.
16162030|NCT01687790|Device|molecular breast imaging (Discovery)|
16162031|NCT01687777|Biological|Mesenchymal Stem Cells (MSCs)|20.000.000 autologous MSCs included in the OrthADAPT membrane. Single dosage.
16162033|NCT01687764|Other|Attentional Bias Modification Treatment (ABMT) - Active|The ABMT consists of 160 trials (120 angry-neutral and 40 neutral-neutral presentations). In the ABM condition, the target appears at the neutral-face location in all angry-neutral trials. Probe type (< or >) is not factorially counterbalanced but appears with equal probability for each of the following: angry-face location, probe location, or actor.
16162034|NCT01687764|Other|Attentional Bias Modification Treatment - Placebo|The Placebo protocol consists of 160 trials (120 angry-neutral and 40 neutral-neutral presentations). In the placebo condition, angry-face location, probe location, and actor are fully counterbalanced in presentation.
16162035|NCT01687764|Behavioral|Cognitive Behavioral Group Therapy|"FRIENDS for Life Australian protocol for the treatment of anxiety disorders in children"
16162036|NCT01687764|Behavioral|Psychoeducational Control Intervention|Psychoeducational control intervention provides only brief psychoeducational information about anxiety associated with general educational activities
16162037|NCT01687751|Drug|Dexmedetomidine|"Study drugs will be administered by continuous subcutaneous infusion using a weight based protocol at a rate between 1.0 to 5.5 mL/hr.
~The study drug will be started at a rate of 1.0 mL/hr.
~The infusion rate is incremented by 0.5 ml/hr every 30 minutes until acceptable symptom control, bradycardia (heart rate < 40) or hypotension (systolic blood pressure < 80) prevent further increase or maximum infusion rate of 5.5 ml/hr, whichever comes first. Achievement of acceptable symptom control will be defined, for purposes of this trial, as a consensus between reports from patient, family care giver and attending registered nurse"
16162038|NCT01687751|Drug|Midazolam|"Study drugs will be administered by continuous subcutaneous infusion using a weight based protocol at a rate between 1.0 to 5.5 mL/hr.
~The study drug will be started at a rate of 1.0 mL/hr.
~The infusion rate is incremented by 0.5 ml/hr every 30 minutes until acceptable symptom control, bradycardia (heart rate < 40) or hypotension (systolic blood pressure < 80) prevent further increase or maximum infusion rate of 5.5 ml/hr, whichever comes first. Achievement of acceptable symptom control will be defined, for purposes of this trial, as a consensus between reports from patient, family care giver and attending registered nurse"
16162039|NCT01687738|Other|communication intervention|Because of the gaps between documented outcomes of lung cancer surgery and patient communication barriers identified in our recent work, our communication intervention will focus on improving presentation of risk information and confirmation of understanding of patient medical.
16162040|NCT01687738|Other|Real Time Registry and data feedback only|This group of patients will not received the enhanced communication intervention
16162041|NCT01687725|Device|Renal denervation using Symplicity Catheter system|percutaneous selective renal sympathetic nerve ablation with the use of the Symplicity Catheter system
16162042|NCT01687712|Drug|AFOLIA|225IU subcutaneously, starting at the day of successful down-regulation for the first 5 days, followed by a treatment period with an increased dose until the point of ovulation induction has been reached
16162043|NCT01687712|Drug|Gonal-f® RFF|225IU subcutaneously, starting at the day of successful down-regulation for the first 5 days, followed by a treatment period with an increased dose until the point of ovulation induction has been reached
16162044|NCT01687699|Drug|Spironolactone|
16162045|NCT01687673|Drug|Temsirolimus|10 mg weekly will be administered intravenously over 30 to 60 minutes using an infusion pump starting on Cycle 1, Day 1 of study enrollment.
16162046|NCT01687673|Drug|Sorafenib:|200 mg tablet twice daily starting on Cycle 1, Day 1 of study enrollment after completion of temsirolimus infusion.
16162047|NCT01687660|Other|acupuncture|apply acupuncture to prevent the migraine attack
16162048|NCT01687647|Other|low-dose CT-scan AND induced sputum sample AND blood test|All subjects will receive a low-dose CT-scan, a blood test (ancillary study) and provide an induced sputum
16162049|NCT01687634|Behavioral|In-home Mentor Mother visits|Pregnant women will receive twice-monthly in-home (or telephone) visits from a Mentor Mother who will provide information about pregnancy, breastfeeding, nutrition, and infant care.
16162050|NCT01687634|Behavioral|Health Information Mailings|Pregnant women will receive twice-monthly mailings that will provide information about pregnancy, breastfeeding, nutrition, and infant care.
16162051|NCT01687621|Procedure|Diagnostic Algorithm for Community Based Worker for Omphalitis|After obtaining guardian informed written consent, newborns aged 1-10 days presenting to the health facility for routine or sick visits would undergo 2 independent, parallel evaluations; first, by a ZamCAT Field Monitor (community level worker from our existing study) and the second by a Zambian medical doctor (gold standard). A US board of pediatrics-certified pediatrician will perform a third independent assessment of a photo of the cord remotely. Using the on-site clinician as the gold standard, the community-based algorithm and the photo assessment will be tested for concordance and the sensitivity and specificity of the algorithm will be generated. Likewise, the remote pictorial assessment will be compared to the gold standard to determine reliability of diagnosis from photographs alone.
16162053|NCT01687595|Drug|HerpV and QS-21|HerpV (recombinant human heat shock protein 70 [rh-Hsc70] polyvalent peptide complex) in combination with adjuvant QS-21
16162054|NCT01687595|Drug|Placebo|phosphate buffered saline
16162055|NCT01687582|Drug|GLP-1 analog|GLP-1 analog treatment
16162056|NCT01687569|Other|Control Cracker Snack|Base cracker snack
16162057|NCT01687569|Other|Experimental Cracker Snack 1|Cracker snack containing test ingredient 1
16162058|NCT01687569|Other|Experimental Cracker Snack 2|Cracker snack containing test ingredient 2
16162059|NCT01687556|Other|topical EGCG application on acne|two times application of topical EGCG on acne lesion
16162060|NCT01687543|Dietary Supplement|L. plantarum 299 and L. plantarum 299v (+maltodextrin)|A suspension of Lactobacillus plantarum 299 and Lactobacillus plantarum 299v together with maltodextrin is distributed to the patients twice a day.
16162061|NCT01687543|Other|Maltodextrin|A suspension of maltodextrin (as placebo control) is distributed to the patients twice a day.
16162062|NCT01687530|Procedure|AMCA Bone Membrane.|AMCA Bone Membrane, as a bone stimulating aid for orthopedic trauma applications.
16162063|NCT01687517|Drug|Seasonal influenza vaccine available for the 2012-2013 vaccine campaign|Single injection of the vaccine at D0 (0.5mL intra-muscularly or subcutaneous for patient under anticoagulant treatment)
16162064|NCT01687491|Drug|ENOXA®|enoxaparine 100 UI/Kg subcutaneous injection
16162065|NCT01687491|Drug|LOVENOX®|enoxaparine 100 UI/Kg subcutaneous injection
16162067|NCT01687478|Drug|Fluoxetine|Administered Orally
16162068|NCT01687478|Drug|Placebo|Administered Orally
16162069|NCT01687465|Procedure|Argon laser trabeculoplasty|With Argon laser trabeculoplasty (ALT), thermal energy is used directed towards the Trabecular Meshwork (the site of aqueous drainage from the eye),which causes focal scarring of trabecular meshwork, thus enable fluid drainage more effectively. However, this procedure may not be repeatable since it causes too much damage to the trabecular meshwork.
16162070|NCT01687465|Procedure|Selective laser trabeculoplasty|Selective laser trabeculoplasty is a relatively newer technology that uses a Nd:YAG laser to target specific cells within the trabecular meshwork. SLT does not cause coagulative damage to the trabecular meshwork, and thus has the advantage of being repeatable.
16162071|NCT01687452|Biological|Blood samples|
16162072|NCT01687439|Drug|Endostar|7.5mg/m2, D1-14
16162073|NCT01687439|Drug|Vinorelbine|25-30mg/m2, D1,8
16162074|NCT01687439|Drug|Cisplatin|25 mg/m2, D1-3
16162075|NCT01687439|Radiation|Radiotherapy|
16162076|NCT01687426|Drug|Brimonidine Tartrate 0.025%|1 drop in each eye daily four times a day for 14 days
16162077|NCT01687426|Drug|Vehicle|1 drop in each eye daily four times a day for 14 days
16162078|NCT01687413|Radiation|Intensity-modulated radiation therapy (IMRT)|
16162079|NCT01687413|Drug|Cisplatin|
16162080|NCT01687400|Drug|decitabine|
16162081|NCT01687387|Drug|IPH2102 at 0.1 mg/kg|every 3 months
16162082|NCT01687387|Drug|IPH2102 at 1 mg/kg|every 4 weeks
16162083|NCT01687387|Drug|Placebo (normal saline solution)|every 4 weeks
16162084|NCT01687374|Drug|1-84 parathyroid hormone|100 micrograms of 1-84 parathyroid hormone daily for 8 weeks, subcutaneous injection.
16162085|NCT01687374|Drug|Placebo|Saline injection daily for 8 weeks.
16162086|NCT01687361|Dietary Supplement|branched-chain amino acids (BCAA) supplementation|
16162087|NCT01687361|Drug|PLACEBO|
16162088|NCT01687348|Drug|lidocaine aguettant|
16162089|NCT01687335|Other|answering questionnare in differents time of the treatment|
16162090|NCT01687309|Drug|GSK2586184 800mg single and repeat dose|GSK2586184 800mg single dose and then twice daily dosing for 13 days
16162091|NCT01687309|Drug|Placebo-to-match GSK2586184|Placebo-to-match GSK2586184
16162092|NCT01687309|Other|GSK2586184 single dose taken with food|GSK2586184 single dose taken with FDA approved high fat, high calorie breakfast
16162093|NCT01687309|Other|GSK2586184 single dose taken without food|GSK2586184 single dose taken in a fasted state
16162094|NCT01687296|Drug|fluticasone propionate inhalation solution|2×0.5mg/2ml twice daily nebulized to treat an acute exacerbation of asthma for 7 days
16162095|NCT01687296|Drug|oral prednisone|once daily (2mg/kg.day, up to 40mg/day for 4 days, then 1mg/kg.day or half of the original dose, up to 20mg/day for 3 days) to treat an acute exacerbation of asthma for 7 days
16162096|NCT01687296|Drug|placebo inhalation solution|4ml 0.9% saline nebulized twice daily
16162097|NCT01687296|Drug|placebo tablet|placebo soluble tablet, oral ,once daily
16162098|NCT01687296|Drug|salbutamol|Salbutamol MDI 2 puffs twice daily or Nebules twice daily, and can be increased up to every 4 hours on an as-needed basis, through the treatment period.
16162099|NCT01687283|Drug|fluticasone propionate inhalation solution|1 mg BID inhalation for 12 weeks with one possible chance to change to 0.5 mg BID
16162100|NCT01687283|Drug|budesonide suspension|2 mg BID inhalation for 12 weeks with one possible chance to change to 1 mg BID
16162101|NCT01687270|Drug|Sofosbuvir|Sofosbuvir 400 mg tablet administered orally once daily
16162102|NCT01687270|Drug|RBV|Ribavirin (RBV) 200-mg tablet(s) administered orally in a divided daily dose starting at 400 mg, subsequently adjusted (range: 200 to 1200 mg in a divided daily dose) based upon a number of factors including hemoglobin value, creatinine clearance, and weight.
16162103|NCT01687257|Drug|SOF|SOF 400 mg tablet administered orally once daily
16162104|NCT01687257|Drug|RBV|RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16162105|NCT01687244|Drug|INSTILADRIN|The INSTILADRIN components will be mixed with a diluent. The total dose will be given as a single, one-hour intravesical administration which may, depending on clinical response, be repeated every 3 months up to a maximum of 4 instillations.
16162106|NCT01687231|Other|Non-neutropenic Diet|Non-neutropenic diet is without restriction.
16162107|NCT01687218|Drug|Oral FTC/TDF (Daily Emtricitabine/Tenofovir Disoproxil fumarate Tablet)|
16162108|NCT01687218|Drug|Rectal Daily TFV RG 1% gel (Rectally applied Tenofovir Reduced Glycerin 1% Gel)|
16162109|NCT01687218|Drug|Rectal RAI-associated TFV RG 1% gel (Receptive Anal Intercourse Associated rectally applied Tenofovir Reduced Glycerin 1% Gel)|
16162110|NCT01687205|Drug|1% Tenofovir Gel|
16162111|NCT01687192|Biological|HPV prophylactic vaccine Gardasil|3 injections: at Inclusion visit then 2 and 6 months after.
16162112|NCT01687179|Drug|"Sirolimus and Hydroxychloroquine 200 mg"|"This will be a phase I dose escalation study of the combination of Sirolimus (2 mg adjusted to keep trough levels between 5-15 ng/ml) and Hydroxychloroquine 200 mg taken orally daily."
16162113|NCT01687179|Drug|"Sirolimus and Hydroxychloroquine 400 mg"|Once safety is established with the lower dose, (Sirolimus and Hydroxychloroquine 200 mg), subjects will receive Sirolimus 2 mg (adjusted to keep trough levels between 5 to 15 ng/ml) and hydroxychloroquine 200 mg twice a day.
16162114|NCT01687166|Device|Blazer Open-Irrigated Ablation Catheter (Boston Scientific)|
16162115|NCT01687166|Device|FDA Approved Open-Irrigated Ablation Catheter|
16162116|NCT01687140|Drug|D-Cycloserine|Take one pill a day 4 times weekly immediately preceding the treatment session for two weeks of treatment (4 sessions weekly).
16162117|NCT01687140|Drug|Placebo|Take one pill a day 4 times weekly immediately preceding the treatment session for two weeks of treatment (4 sessions weekly).
16162118|NCT01687127|Dietary Supplement|Folic acid|Supplement
16162119|NCT01687127|Dietary Supplement|5-methyltetrahydrofolate, calcium salt|Supplement
16162120|NCT01687114|Other|cranberry juice|27% cranberry juice
16162171|NCT01686633|Drug|Fluticasone Furoate/ Vilanterol 100/25 mcg|Fluticasone furoate/ vilanterol will be available as 100/25 mcg NDPI with 30 doses per device and 100/25 mcg per actuation
16162121|NCT01687101|Drug|STOPAIN topical gel|STOPAIN topical gel is topical menthol 6% gel applied as 2 to 4 pumps of gel applied behind the ears and to the occipital region of the neck in one or two applications within 2 hours of the onset of the migraine.
16162122|NCT01687075|Device|CR8 a drug eluting coronary stent|a drug eluting coronary device, made of Cobalt-Chromium alloy and integrally coated with i-Carbofilm™, loaded with formulated Sirolimus
16162123|NCT01687062|Other|FeSO4|
16162124|NCT01687062|Other|reduction of phytate|
16162125|NCT01687062|Other|NaFeEDTA|
16162126|NCT01687049|Drug|Red yeast rice|
16162127|NCT01687036|Device|Cryoablation|Cryoablation of Atrial Fibrillation Using a Novel Cryoablation System
16162128|NCT01686997|Procedure|Roux-en-Y Gastric Bypass|
16162129|NCT01686984|Other|Altered breath|
16162130|NCT01686958|Device|MR-Guided Transurethral US Ablation of Prostate Tissue|The technology is developed to treat patients with organ confined prostate cancer. The therapeutic endpoint of this technology is thermal coagulation of prostate tissue.
16162131|NCT01686945|Drug|semaglutide|Start doses of 5 mg and 10 mg with end dose of 20 mg. For oral administration.
16162132|NCT01686945|Drug|semaglutide|Start doses of 5 mg and 10 mg with end doses of either 20 mg or 40 mg. For oral administration.
16162133|NCT01686945|Drug|semaglutide|Start doses of 5 mg and 10 mg with end doses of either 20 mg, 40 mg or 60 mg. For oral administration.
16162134|NCT01686945|Drug|placebo|Placebo semaglutide. For oral administration.
16162135|NCT01686945|Drug|placebo|Placebo semaglutide with carrier. For oral administration.
16162136|NCT01686932|Drug|Vildagliptin|vildagliptin 50mg BID for 8 weeks
16162137|NCT01686932|Drug|Sitagliptin|sitagliptin 100mg QD for 8 weeks
16162138|NCT01686919|Dietary Supplement|milk-free|milk-free diet during 8 preoperative weeks
16162139|NCT01686906|Procedure|Bowman layer graft implantation|For patients with progressive advanced keratoconus, a mid-stromal manual dissection is made and a donor isolated Bowman layer is positioned into the stromal pocket.
16162140|NCT01686893|Device|Nasal oxygen insufflation with a TNI 20 oxy device|Nasal oxygen insufflation with a TNI 20 oxy device
16162141|NCT01686893|Device|Standard Nasal Insufflation of oxygen|Standard Nasal Insufflation of oxygen
16162142|NCT01686880|Device|Sirsphere trans-arterial radioembolization|Patients will receive Sirsphere trans-arterial radioembolization before surgery
16162143|NCT01686867|Device|Improved, ventilated cookstove|"An improved, ventilated cookstove incorporates the following key elements: burner openings customized to the size and shape of the cooking utensils; a flue designed to draw air into the fire box and pass it out through a chimney; a chimney, vented to the exterior, of adequate height to create a draft; an exterior port that has bidirectional openings to prevent the backflow of smoke and an access port for the chimney that permits cleaning.
~The investigators piloted cookstoves prior to the trial and compared their ability to reduce indoor air pollution, the reliability between cookstoves of the same type, the functionality over time, preferences and cultural compatibility, and cost. The investigators selected the the Envirofit G-3300/3355, a modified Stovetec cookstove with a chimney and a locally-made improved, ventilated cookstove for use in the trial."
16162144|NCT01686854|Behavioral|Cognitive Behavioral (B)|a 12 months training program in small groups (max 10 persons) about problem solving strategies. Each 90 minute lesson will be given by clinicians, psicologist, dieticians, according cognitive behavioural approach and strategies.
16162145|NCT01686854|Other|Prescriptive Diet (A)|prescribed diet, with a reduction of 500 Kcal for overweight-1° degree obese, and of 800-1000 Kcal for 2° degree obese patients respect caloric requirement, in compliance with Italian guidelines (INRAN 2003).
16162146|NCT01686841|Device|The Zeltiq System|Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
16162147|NCT01686828|Drug|Acyline|300 mcg/mL administered subcutaneously (at Day 0, Week 2)
16162148|NCT01686828|Drug|Testosterone 1.62% gel|Transdermal Testosterone Gel (either 1.25g or 5g/d) for 4 weeks
16162149|NCT01686828|Drug|Letrozole|Letrozole oral aromatase inhibitor 5mg daily for 4 weeks
16162150|NCT01686828|Drug|Placebo gel (for Testosterone 1.62% gel)|placebo gel manufactured to mimic Testosterone 1.62% gel
16162151|NCT01686828|Drug|Placebo pill (for Letrozole)|Oral placebo aromatase inhibitor to mimic Letrozole 5mg/d
16162152|NCT01686802|Drug|oral morphine|
16162153|NCT01686802|Drug|Ibuprofen|
16162154|NCT01686789|Drug|Pegylated interferon alpha-2a|
16162155|NCT01686776|Other|123 I-HSA + 125 I HSA|Compare and validate the method of measuring albumine turnover rate
16162156|NCT01686750|Behavioral|Integrated care centers|
16162157|NCT01686737|Behavioral|Iyengar Yoga|"12 weeks of Iyengar yoga
~2 weekly sessions of 60 minutes"
16162158|NCT01686737|Behavioral|Walking|"12 weeks of walking
~2 weekly sessions of 60 minutes"
16162159|NCT01686724|Behavioral|Collaborative Life Skills Intervention (CLS)|CLS is a 12-week program and includes school, parent, and student components which are integrated via joint teacher, parent, and student meetings and use of integrated behavioral programs in the classroom, on the playground, and at home.
16162160|NCT01686724|Other|Business As Usual|
16162161|NCT01686711|Drug|AD-4833 15 mg|
16162162|NCT01686711|Drug|AD-4833 30 mg|
16162163|NCT01686711|Drug|Placebo|
16162164|NCT01686698|Dietary Supplement|VSL#3 (Original De Simone formulation)|VSL#3 (Original De Simone formulation) is a probiotic mixture of 8 proprietary strains, namely Streptococcus thermophilus, bifidobacteria and lactobacilli.
16162165|NCT01686698|Other|Placebo|Placebo will be formulated as identical in appearance and administered according to the same schedule as the active agent. Placebo contains maltose and silicon dioxide as inactive agent.
16162166|NCT01686672|Behavioral|Web Intervention|Behavioral
16162167|NCT01686659|Device|Continuous Noninvasive Hemoglobin Monitoring|Availability of data from a continuous noninvasive hemoglobin monitoring device (total hemoglobin [SpHb] and Pleth Variability Index [PVI]) to the clinicians in the operating room
16162168|NCT01686646|Drug|paracetamol + caffeine|paracetamol with caffeine
16162169|NCT01686646|Drug|paracetamol|paracetamol
16162170|NCT01686633|Drug|Fluticasone Furoate/ Vilanterol 200/25 mcg|Fluticasone furoate/ vilanterol will be available as 200/25 mcg Novel dry powder inhaler (NDPI) with 30 doses per device and 200/25 mcg per actuation
16162172|NCT01686633|Drug|Fluticasone Furoate 100 mcg|Fluticasone furoate will be available as 100 mcg NDPI with 30 doses per device and 100/25 mcg per actuation
16162173|NCT01686620|Drug|BIOD-123|
16162174|NCT01686620|Drug|Lispro (Humalog)|
16162175|NCT01686607|Drug|Parenteral micafungin application|Parenteral
16162176|NCT01686607|Drug|Other parenteral antifungal drugs|Parenteral
16162177|NCT01686594|Drug|8-methoxypsoralen|8-methoxypsoralen 10mg per 20 kg body weight 1 hour before UVA exposure
16162178|NCT01686581|Drug|botulinum toxin Type A|Botulinum toxin Type A (BOTOX®) administered according to physician prescription.
16162179|NCT01686568|Drug|Omega-3|Patients in this group will receive oral supplementation with EPA+DHA (3.9grams/day) for 6 months.
16162180|NCT01686568|Drug|placebo|
16162181|NCT01686555|Drug|ABT-199|Tablet
16162182|NCT01686555|Other|Placebo|Tablet
16162183|NCT01686542|Procedure|CPVI plus renal sympathetic modification|CPVI plus renal denervation to reduce atrial arrhythmia recurrence.
16162184|NCT01686542|Procedure|CPVI|CPVI alone to reduce atrial arrhythmia recurrence.
16162185|NCT01686529|Procedure|Autoconjunctival grafting|The pterygium head was lifted off the corneal surface by blunt dissection. The pterygium body was dissected from the underlying sclera and thereafter excised. A thorough removal of Tenon's capsule was performed in an area much greater than the pterygium body. Free conjunctival autografting after pteryigum excision was performed as follows: the desired size of the conjunctiva under the upper eyelid was marked and excised. No limbal tissue was included in the graft. The excised tissue was placed on the bare sclera and tightly sutured to the sclera and the limbal area. Finally the autograft edges were sutured to the conjunctiva all around.
16162186|NCT01686529|Drug|Subconjuntival bevacizumab injection|The subconjunctival injection of bevacizumab was applied adjacent to the site of pterygium separation inside the healthy conjunctiva. The half of the dose (1.25 mg/0.05ml) was applied in the nasal inferior quadrant, and the other half of the dose was applied in the nasal superior quadrant.
16162187|NCT01686503|Drug|IPOL (Sanofi Pasteur) inactivated polio vaccine booster dose|Depending on study arm, participants will receive 0.2 mL intradermally, 0.1 mL intradermally, 0.5 mL intramuscularly, or 0.2 mL intramuscularly.
16162188|NCT01686490|Behavioral|Video/workbook for patients about to receive an AICD|will view the 3 completed sections of the video/workbook
16162189|NCT01686490|Behavioral|LiveSkills Video/Workbook for patients about to receive an AICD|This exploratory intervention first met in a focus group with healthcare professionals and another focus group with patients who already had received an automatic implantable cardiac defibrillator to learn more about what video and accompanying workbook material it would be helpful for patients to receive pre-inplantation. Another focus group was held with post-implantation patients asking them what additional knowledge would have been helpful. Three sections of the video with accompanying workbook were then produced and given to pre-inplantation patients. A focus group was then held with these patients after their procedure to ask them what had and had not proved helpful.
16162190|NCT01686477|Other|Unfortified Human donor Milk used to make up any shortfall in mother's own milk|
16162191|NCT01686477|Other|Fortified Human donor Milk used to make up any shortfall in mother's own milk|
16162192|NCT01686477|Other|Preterm Formula used when there is a shortfall in mother's own milk|
16162193|NCT01686464|Drug|prednisone and valacyclovir treatments|patients were administered prednisone as a single dose of 40 mg daily for 5 days; the dose will then be reduced by 10 mg per 5 day, with a total treatment time of 20 days.while taking valacyclovir 400 mg in three doses daily for 10 days.
16162194|NCT01686464|Device|Magnetic and Oxygen Treatment|MOMC treatment was given as daily 20 min section for 10 days with 2~3 days of intermission between. Oxygen therapy was given simultaneously at a flow rate of 2~3.0 L / min for the same duration during all acupuncture sections.
16162195|NCT01686451|Drug|XueZhiKang|Participants will receive 600mg of XueZhiKang twice a day for 4 weeks.
16162196|NCT01686451|Drug|simvastatin|Participants will receive 20mg of simvastatin daily for 4 weeks.
16162197|NCT01686438|Behavioral|Cognitive behavioral therapy for insomnia|A behavioral modification program consisting of 6 clinic sessions focused on sleep hygiene, stimulus control, sleep restriction, and cognitive restructuring.
16162198|NCT01686425|Procedure|Percutaneous transhepatic cholangiography vs. endoscopic biliary drainage|Percutaneous transhepatic cholangiography biliary drainage is compared tot endoscopic biliary drainage in the management of malignant biliary obstruction not amenable to ERCP
16162199|NCT01686412|Device|Electromagnetic Fields of Low Energy (EEFLE)|Are employed three sets of programs of different frequencies are modulated specifically for each group of patients in accordance with diagnostic (hepatocellular carcinoma, breast carcinoma and healthy subjects). These frequencies ranging between 0.1 and 114.000Hz.
16162200|NCT01686399|Behavioral|Nutritional and Activity Promotion|Multi disciplinary nutritional and behavioral messages to improve diet and activity levels
16162201|NCT01686386|Drug|Bendamustine|Phase I: dose escalation of Bendamustine Phase II: Dexamethasone will be given in combination with the MTD of Bendamustine and Lenalidomide in cycles lasting 28 days.
16162202|NCT01686386|Drug|Lenalidomide|Phase I: dose escalation of Lenalidomide Phase II: Dexamethasone will be given in combination with the Maximum Tolerated Dose (MTD) of Bendamustine and Lenalidomide in cycles lasting 28 days.
16162203|NCT01686386|Drug|Dexamethasone|Phase I and Phase II Dexamethasone fixed dose 40 mg/die
16162204|NCT01686373|Device|Activa Dose II Real tDCS|20 minutes of 1 milliamp active tDCS per treatment day (15 total sessions)
16162205|NCT01686373|Device|Activa Dose II Sham tDCS|20 minutes of sham stimulation per treatment day (15 total sessions)
16162206|NCT01686360|Behavioral|Decision Aid|
16162207|NCT01686347|Drug|ropivacaine|
16162208|NCT01686334|Biological|DC vaccine|Autologous WT1 mRNA-electroporated DCs
16162209|NCT01686321|Drug|Bendamustine and subcutaneous rituximab|
16162210|NCT01686308|Procedure|Yellow Intra Ocular Lens (IOL)|Standard operation with blue light filter Yellow IOL implantation
16162211|NCT01686308|Procedure|Conventional Intra Ocular Lens (IOL)|Standard operation with conventional IOL implantation
16162212|NCT01686295|Device|iRestore Hair Rejuvenation System|This study is to evaluate the effectiveness of the iRestore Hair Rejuvenation System when used as directed in promoting hair growth in men and women with androgenetic alopecia 3 times a week for 30 minutes on non-consecutive days
16162213|NCT01686295|Device|sham device|This shame device will be a sham comparator to evaluate the effectiveness of the iRestore Hair rejuvenation System when used as directed in promoting hair growth in men and women with androgenetic alopecia 3 times a week for 30 minutes on non-consecutive days
16162214|NCT01686282|Dietary Supplement|Freeze-dried Blueberry Powder|8 weeks of freeze-dried taken in two doses of 22g each per day.
16162215|NCT01686282|Dietary Supplement|Placebo|8 weeks of freeze-dried taken in two doses of 22g each per day.
16162216|NCT01686269|Procedure|blood collecting|
16162217|NCT01686256|Drug|Tc 99m EC20|Each subject will receive 1 mg of folic acid injected 1-3 minutes prior to administration of Technetium Tc 99m EC20.
16162218|NCT01686243|Other|epidural needle placement with echogenic 17G Tuohy needles (Pajunk TuohySono)|Anesthesiologist will place epidural with aid of ultrasound and placement with echogenic 17G Tuohy needles (Pajunk TuohySono)
16162219|NCT01686243|Other|standard epidural placement|Anesthesiologist will place epidural within standard practice, with standard needles.
16162220|NCT01686230|Other|acupuncture|In each session, we treat bilaterally, 3 times a week and 2 days off a week, each patient in the acupuncture treatment groups will receive 12 sessions of acupuncture treatment over 4 weeks. The whole study period is 20 weeks including 4-week baseline period,4-week treatment period, and 12-week follow-up period. we will investigate at 0 day,4week,8week,12week,16week after randomization。
16162221|NCT01686230|Drug|Basic treatment|"Each group in the basic treatment，Foundation treatment including health education and basic drug therapy.
~We recommend lifestyle modification for all patients. Modifications include increasing exercise; limiting alcohol consumption; and weight loss; quit smorking etc.
~Basic medication： Aspirin: 100mg qd; Metoprolol：25mg bid; Ramipril:5mg qd; Atorvastatin:20mg qn."
16162222|NCT01686217|Drug|ASP015K ER|oral extended release (ER) at three dosing levels
16162223|NCT01686217|Drug|ASP015K IR|oral immediate release (IR)
16162224|NCT01686204|Other|Low fat dairy yogurt|Consumption of 12 oz of low fat dairy yogurt daily for 9 weeks
16162225|NCT01686204|Other|Soy pudding|Consumption of 12 oz of low fat soy pudding daily for 9 weeks.
16162226|NCT01686178|Behavioral|Anti-smoking social marketing campaign|We will utilize industry market research tools to define the target audience (segment of community with high smoking prevalence and high social influence) and directly counter tobacco industry lifestyle marketing strategies through local promotion of a smokefree brand and branded bar and club events.
16162227|NCT01686165|Drug|belinostat|Given IV
16162228|NCT01686165|Biological|rituximab|Given IV
16162229|NCT01686165|Radiation|yttrium Y 90 ibritumomab tiuxetan|Given IV
16162230|NCT01686152|Drug|Imiquimod Cream, 3.75%|
16162231|NCT01686152|Drug|Zyclara®|
16162232|NCT01686152|Other|Vehicle of Test Product|
16162233|NCT01686139|Biological|ABMD-MSC|10-20 x 10^6 cells/20mL
16162234|NCT01686126|Drug|Levonorgestrel|Intrauterine device
16162235|NCT01686126|Drug|Metformin|oral medication
16162236|NCT01686113|Other|NEFA|
16162237|NCT01686113|Other|Sucrose|
16162238|NCT01686100|Procedure|No touch technique|The vein graft is harvested with its surronding tissues.
16162239|NCT01686100|Procedure|Conventional technique|The vein graft is stripped from its surrounding tissues.
16162240|NCT01686087|Behavioral|Monthly Booster Sessions of EX/RP|45 minute EXRP booster sessions each month
16162241|NCT01686087|Procedure|Visits with MD and independent evaluators|All patients will be followed carefully and evaluated by their study doctor and an independent evaluator to assess their symptoms.
16162242|NCT01686061|Other|No intervention- only one time survey|
16162243|NCT01686022|Other|Immunoblot|serum specific IgE binds to grass extract by immunoblot
16162244|NCT01686009|Drug|Intra-nasal ketamine|
16162245|NCT01685996|Drug|zonisamide|In addition to zonisamide vs placebo treatment, varenicline tablets will be dispensed with specific instructions to take at the recommended doses for smoking cessation Participants will receive brief smoking cessation counseling and referral to a quitline
16162246|NCT01685996|Drug|placebo|
16162247|NCT01685983|Drug|Abiraterone acetate|Type=exact number, unit=mg, number=250, form=tablet, route=oral. Patients will receive 4 tablets of abiraterone acetate at least 1 hour before a meal or 2 hours after a meal any time up to 10 pm every day.
16162248|NCT01685983|Drug|Prednisolone|Type=exact number, unit=mg, number=5, form=tablet, route=oral. Patients will receive 1 tablet of prednisolone twice daily.
16162249|NCT01685970|Drug|High volume split-dose PEG|High volume split-dose PEG 2L/2L 2 times before the day and at the day of colonoscopy
16162250|NCT01685970|Drug|2 sachets of picosulfate|2 sachets of picosulfate 2 times for bowel preparation at the day of colonoscopy
16162251|NCT01685957|Behavioral|Standard dietary treatment (STD)|This group will receive 6 one-on-one sessions with a registered dietitian. Total time spent is 6½ hour. Dietary treatment is based national guidelines and counseling is individualized and tailored to the patient's needs and goals.
16162252|NCT01685957|Behavioral|"Ned i vaegt (NIV)"|"This group will receive 3 individual sessions and 3 group sessions. All sessions are with a registered dietitian. Total time spent is 15½ hour. The group sessions consist of 1 hour theory and 2½ hour cooking skills. The whole intervention is based on a danish self-help weightloss book which is based on the national dietary guidelines. Focus is to learn to make normal danish dishes in a more healthy way both ingredients, cooking, composition and quantity. They also learn about changing habits, making realistic goals and using their motivation."
16162253|NCT01685957|Behavioral|"Verdens bedste kur (VBK)"|"This group will receive 3 individual sessions and 3 group sessions. All sessions are with a registered dietitian. Total time spent is 15½ hour. The group sessions consist of 1 hour theory and 2½ hour cooking skills. The whole intervention is based on a danish self-help weightloss book which is based on new nordic diet and are a relative low-GI and high-protein diet. Focus is to learn to make new healthy dishes both ingredients, cooking and composition. They also learn about making realistic goals."
16162254|NCT01685944|Dietary Supplement|Live Pediococcus pentosaceus LP28|
16162255|NCT01685944|Dietary Supplement|Heat-killed Pediococcus pentosaceus LP28|
16162256|NCT01685944|Dietary Supplement|Placebo|
16162257|NCT01685931|Drug|Paliperidone Palmitate|One intramuscular injection of paliperidone palmitate flexible dose will be administered on Day 1, Day 8, and monthly thereafter.
16162258|NCT01685892|Drug|Obinutuzumab|Participants will receive IV infusion of obinutuzumab 100 milligrams (mg) on Day 1 of Cycle 1, 900 mg on Day 2 of Cycle 1, and 1000 mg on Days 8 and 15 of Cycle 1 and on Day 1 of Cycles 2-6.
16162259|NCT01685892|Drug|Venetoclax|Participants will receive multiple doses of venetoclax orally once daily.
16162260|NCT01685879|Other|Rice|Rice portion containing 50 g total carbohydrate
16162261|NCT01685879|Other|Rice|Rice portion that provides 50 g total carbohydrate.
16162262|NCT01685879|Other|Rice|Rice portion that provides 50 g total carbohydrate.
16162263|NCT01685879|Other|Glucose Beverage|Glucose beverage that provides 50 g total carbohydrate.
16162264|NCT01685866|Device|Vein-Viewer Vision|A medical device called Vein-Viewer Vision
16162265|NCT01685853|Drug|Bisacodyl plus PEG-CS|"the day before colonoscopy: 3-4 bisacodyl tablets (according to patient bowel habit) at bedtime
~the morning of colonoscopy: PEG-CS (2 litres) starting 5 hours before the exam"
16162266|NCT01685853|Drug|PEG 4 litres split|"the day before colonoscopy: 2 litres of PEG
~the morning of colonoscopy: 2 litres of PEG starting 5 hours before the examination"
16162267|NCT01685840|Other|Usual Care|Usual Care
16162268|NCT01685840|Device|Biomarker-guided care NT-proBNP|Device: NT-proBNP
16162269|NCT01685827|Drug|Fexinidazole|
16162270|NCT01685827|Drug|Nifurtimox|
16162271|NCT01685827|Drug|Eflornithine|
16162272|NCT01685814|Drug|Lenalidomide, Bortezomib|Induction: two versus one novel drug maintenance: lenalidomide as a maintenance therapy
16162273|NCT01685814|Biological|autologous stem cell transplant|
16162274|NCT01685814|Biological|allogeneic stem cell transplant|
16162275|NCT01685801|Drug|Ivacaftor|150 milligram (mg) tablet orally every 12 hours up to 12 weeks.
16162276|NCT01685801|Drug|Placebo-matched-to-ivacaftor tablet|Orally every 12 hours up to 4 weeks.
16162277|NCT01685788|Other|No intervention|
16162278|NCT01685775|Procedure|Transvaginal/transumbilical|
16162279|NCT01685775|Procedure|Needlescopic with 3 trocars|
16162280|NCT01685762|Drug|Metformin|850 mg of metformin taken once daily by mouth for 4 weeks (weeks 1-4) and then twice daily by mouth for 8 weeks (weeks 5-12).
16162281|NCT01685723|Behavioral|Counseling group|Subjects will receive brief advice based on risk communication by a nurse counselor. The brief advice will be based on a specifically-designed risk communication leaflet that warns about the risks of continued smoking for subjects' cancer treatment and prognosis. Subjects will receive a booster intervention via telephone at 1 week to assess the progress of and barriers to the subjects' action plans and identifying individual difficulties and facilitators towards quitting. They also receive a generic standard self-help smoking cessation booklet.
16162282|NCT01685723|Behavioral|General supporting|Subjects in this group will receive a generic self-help smoking cessation booklet and standard care without risk communication. They will have the same follow-up sections as the intervention group to receive diseases support.
16162283|NCT01685710|Drug|GTN patch|
16162284|NCT01685710|Drug|placebo comparator|This arm will be a placebo patch to the active drug patch to blind the trial.
16162285|NCT01685697|Procedure|Mask ventilation with a Laerdal face mask|Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the intervention group.
16162286|NCT01685697|Procedure|Mask ventilation with a F&P face mask|Mask leak will be measured using a respiratory function monitor. Mask ventilation will be analyzed over a period of 5 minutes. The mean mask leak will be compared to the control group.
16162287|NCT01685684|Drug|Oxycodone DETERx|40-160 mg total daily dose of oxycodone DETERx, divided into 2 doses, q12h
16162288|NCT01685684|Drug|Placebo|Placebo, divided into 2 doses, q12h
16162289|NCT01685671|Drug|NESP 60μg|Administrated NESP 60μg once subcutaneously
16162290|NCT01685671|Drug|CKD-11101 60μg|Administrated CKD-11101 60μg once subcutaneously
16162291|NCT01685658|Drug|Intravenous ketoprofen|Patients will recieve 100 mg of ketoprofen via slow intravenous perfusion. (100mg of ketoprofen powder for injection dissolved in 100 ml injectable isotonic solution)
16162292|NCT01685658|Drug|Intravenous paracetamol|Patients will receive 1g of paracetamol via slow intravenous perfusion. (100 ml of solution at 10mg/ml)
16162293|NCT01685645|Device|AlgiScan|The AlgiScan device will be used to monitor analgesia during surgery. The integrated nociceptive stimulator will be used on both legs.
16162294|NCT01685632|Procedure|Surgery with IPCH|"surgical debulking and extensive tumoral resection after laparotomy under general anesthesia
~7 blood samples over 72 hours, including 4 samples under general anesthesia throughout surgery and 3 samples during the 3 following days (at 24th, 48th and 72th hours).
~6 tissue biopsies, i.e. 2 from peritoneum disease-free and 2 from invaded peritoneum , each representing a volume less than 1 cm3 and 2 biopsies from healthy colonic tissue for the colon-related cancer and 4 biopsies (peritoneum n=2, tumoral tissue n=2) for ovarian-related cancer. All biopsies are done during the surgery under general anesthesia, and each biopsy per site before/after IPCH"
16162295|NCT01685632|Procedure|Without surgery and without IPCH|"The patients is opened and recused during the surgery because of extended carcinosis and closed without resection neither IPCH.
~7 blood samples over 72 hours, including 4 samples under general anesthesia throughout surgery (2 hours before IPCH, 1.5hours after IPCH, 4 hours after IPCH) and 3 samples during the 3 following days (at 24th, 48th and 72th hours).
~6 tissue biopsies, i.e. 2 from peritoneum disease-free and 2 from invaded peritoneum, each representing a volume less than 1 cm3 and 2 biopsies from healthy colonic tissue for the colon-related cancer and 4 biopsies (peritoneum n=2, tumoral tissue n=2) for ovarian-related cancer. All biopsies are done during the surgery under general anesthesia, and each biopsy per site before/after IPCH"
16162296|NCT01685606|Biological|cellular immunotherapy|A minimum of 1x108 CD3+ cells and maximum of 2x108 CD3+ cells/kg from a haploidentical donor irrespective of the number of CD34+ cells will be infused.
16162297|NCT01685593|Device|abdominal binder|
16162298|NCT01685593|Other|no binder|
16162299|NCT01685580|Device|Manufacturer (VPAP ST)|non-invasive ventilation in two pressure levels 7 days before surgery
16162300|NCT01685567|Device|MICHI NPS+f|Cerebral protection with carotid flow reversal
16162301|NCT01685554|Device|hypothermic CPB|maintenance of mild hypothermia during cardiopulmonary bypass
16162302|NCT01685554|Device|normothermic CPB|maintenance of normal body temperature during cardiopulmonary bypass
16162303|NCT01685541|Other|Maximum After Visit Summary Content|
16162304|NCT01685541|Other|Intermediate After Visit Summary Content|
16162305|NCT01685541|Other|Minimum After Visit Summary Content|
16162306|NCT01685541|Other|Usual AVS|
16162307|NCT01685528|Behavioral|CBT|6-8 weekly sessions of CBT, 1 of which is in person with the rest being over the telephone
16162308|NCT01685515|Drug|Oral Decitabine and Tetrahydrouridine|Oral Decitabine and Oral Tetrahydrouridine (THU) given 1-2 hours apart on 2 consecutive days over 8 weeks
16162309|NCT01685515|Drug|Placebo|Plain water will be dispensed at a similar volume and in the same containers as study drug. The water placebo has a similar appearance and taste to the study drug, since the study drug is highly diluted in water.
16162310|NCT01685502|Drug|Glucobay ODT (Acarbose, BAYG5421)|Patients treated with Glucobay OD under practical manner
16162311|NCT01685489|Drug|Docetaxel, PSK®|
16162312|NCT01685489|Drug|Docetaxel, Placebo|
16162313|NCT01685476|Device|Echodia® hand-held equipment|
16162314|NCT01685463|Device|Transcranial Magnetic Stimulation|Active TMS:1 Hz, 100% motor threshold TMS for 15 minutes, total 900 pulses. Electrical stimulation instead.
16162315|NCT01685463|Device|Sham Transcranial Magnetic Stimulation|The electrical current of the sham system is titrated to a level matching participants' ratings of active TMS. The sham-TMS scalp discomfort will be matched to that of active TMS.
16162316|NCT01685450|Device|Echodia® hand-held equipment|
16162317|NCT01685437|Biological|AA4500|2 injections separated by approximately 24 hours to 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles
16162318|NCT01685424|Drug|Etoricoxib|As per routine clinical practice in the United Kingdom
16162319|NCT01685411|Drug|Allopurinol|Day -8 (prior to transplant): Per institutional guidelines
16162320|NCT01685411|Drug|Keppra|Day -8 (prior to transplant): Per institutional guidelines
16162321|NCT01685411|Drug|Busulfan|Days -7 through -4 (prior to transplant): given intravenously (IV) infusion over 2 hours every 6 hours following dose, administration and pharmacokinetic monitoring per University of Minnesota institutional guidelines.
16162322|NCT01685411|Drug|Cyclophosphamide|Days -3 and -2 (prior to transplantation): given as a 2 hour intravenous infusion with a high volume fluid flush and mesna per institutional guidelines. Dosing is based on actual body weight.
16162323|NCT01685411|Drug|Tacrolimus|All patients (regardless of allograft source) will receive tacrolimus therapy beginning on day -3. Dosing will be monitored and altered as clinically appropriate per institutional pharmacy guidelines. Dose adjustments will be made on the basis of toxicity and/or low tacrolimus levels. Taper at day +100 for matched sibling donor (MSD) recipients, and day +180 for non-MSD recipients. Taper to zero by 10% weekly dose reduction over approximately 10 weeks.
16162324|NCT01685411|Drug|Mycophenolate mofetil|Day -3 (prior to transplant): Recipients of umbilical cord blood will given a dose of 3 gm/day every 8 or 12 hours (> or = 40 kg) or 15 mg/kg 3 times per day (< 40 kg) for up to 30 days unless no engraftment.
16162325|NCT01685411|Biological|Allogeneic hematopoietic stem cell transplant|Day 0 (or Day+1/+2 to accommodate weekdays): Infusion of cells from related or unrelated donor bone marrow or single or double unrelated donor umbilical cord blood.
16162326|NCT01685411|Biological|Filgrastim|Beginning Day +1: Intravenously (IV) 5 mcg/kg once daily and continuing until the absolute neutrophil count is >2500 x 10^9/L or per institutional guidelines.
16162327|NCT01685411|Biological|antithymocyte globulin|Administered per institutional guidelines for recipients of umbilical cord blood transplant.
16162328|NCT01685398|Drug|0.5% timolol maleate eye drop|
16162329|NCT01685398|Drug|Normal saline|
16162330|NCT01685385|Other|Patients who will receive the BNP test|Patients in Diagnostic Intervention Group A will receive the point-of-care BNP test, in addition to all other diagnostics they receive in addition
16162331|NCT01685372|Biological|Fluzone High Dose|A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm
16162332|NCT01685372|Biological|Fluzone|A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm
16162333|NCT01685359|Drug|Epoetin Alfa|Intravenous administration for 4 weeks, three times a week (monday, wednesday, friday)
16162334|NCT01685346|Behavioral|biofeedback-mediated stress management (BFSM)|Therapist and study assistant meet with patient, attach sensors, record physiologic variables and train the patient in relaxation techniques including deep breathing, guided imagery, progressive muscle relaxation, autogenics. Patient is given a handheld thermometer to take home and practice self-regulation between visits, along with a recording sheet to indicate how often practice occurs.
16162335|NCT01685333|Drug|Epoetin Alfa|Intravenous single-dose administration of 100 IU/kg of the test drug (Human Recombinant Epoetin) in the first period and intravenous single-dose administration of 100 IU/kg of the comparator drug (Eprex) in the second period, after 23-30 days of washout, or vice-versa.
16162336|NCT01685320|Procedure|Forces applied by laryngoscope|Force and pressure distribution applied by direct or indirect laryngoscope during glottis visualization and intubation were measured using film pressure transducers.
16162337|NCT01685307|Dietary Supplement|Test meal|test meal is 150 g of beef cooked either at moderate or high intensity. Proteins are intrinsically labelled with 15N.
16162338|NCT01685294|Behavioral|Group IPT for Depression + TAU|Interpersonal psychotherapy (IPT) will be administered in 20 group 90-minute sessions over 10 weeks and 4 individual sessions (before group starts, in the middle of the group, at the end of the group, and one month after the group ends). These sessions will focus on improving your relationships with others, building healthy relationships, setting goals, and increasing coping skills. Additionally, participants will receive standard prison mental health treatment, individual therapy, medication, etc.
16162339|NCT01685281|Drug|Metadoxine (MG01CI)|MG01CI is an orally administered extended release formulation of metadoxine. Doses: 1400 mg and 700 mg and Placebo
16162340|NCT01685281|Drug|Placebo|Placebo tablets will be similar in appearance (color and size) to the investigational product
16162341|NCT01685268|Drug|AT13387|Regimen 1: AT13387, given as 1-hr intravenous infusion at starting dose of 220 mg/m2 once weekly for 3 weeks in a 4-week cycle. Regimen 2: AT13387, given as 1-hr IV infusion at starting dose of 120 mg/m2 on Day 1 and Day 2 weekly for 3 weeks in a 4-week cycle.
16162342|NCT01685268|Drug|abiraterone acetate|1000 mg PO daily.
16162343|NCT01685268|Drug|Prednisone|5 mg PO twice daily.
16162346|NCT01685242|Drug|AC-170 0.24%|1 drop in each eye at 2 separate times during a 14 day period
16162347|NCT01685242|Drug|AC-170 0%|1 drop in each eye at 2 separate times during a 14 day period
16162348|NCT01685229|Device|Balloon sinus dilation|Subjects electing continued medical therapy group will not have balloon sinus dilation intervention. Subjects electing balloon sinus dilation group will have balloon sinus dilation intervention.
16162349|NCT01685229|Drug|Medical Management|Subjects who select to continue on medical management rather than have a BSD procedure.
16162350|NCT01685216|Biological|velaglucerase alfa|lyophilized powder, intravenous infusion, units, Every other week (EOW)
16162351|NCT01685203|Drug|ABT-450/r|Tablet; ABT-450; Capsule; ritonavir
16162352|NCT01685203|Drug|ABT-267|Tablet
16162353|NCT01685203|Drug|Ribavirin (RBV)|Tablet
16162354|NCT01685190|Radiation|Prostate alone IMRT|Participants will receive standard prostate IMRT of 74Gy in 37 fractions delivered over 7.5 weeks.
16162355|NCT01685190|Radiation|Prostate and pelvis IMRT|Participants will receive prostate and pelvis IMRT with a dose of 74Gy in 37 fractions delivered over 7.5 weeks to the prostate and 60Gy in 37 fractions delivered over 7.5weeks to the pelvis.
16162356|NCT01685164|Other|Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.|Evaluation of uterine size and posture with ultrasound, IUD insertion, one year follow-up.
16162357|NCT01685151|Drug|Ramelteon SL (Dose 1)|Ramelteon tablets for sublingual administration
16162358|NCT01685151|Drug|Ramelteon SL (Dose 2)|Ramelteon tablets for sublingual administration
16162359|NCT01685151|Drug|Placebo|Placebo
16162360|NCT01685138|Drug|LDK378|LDK378/Ceritinib was supplied as 150 mg hard gelatin capsules and administered orally
16162361|NCT01685125|Drug|abiraterone acetate|Given PO
16162362|NCT01685125|Drug|dasatinib|Given PO
16162363|NCT01685125|Drug|prednisone|Given PO
16162364|NCT01685073|Drug|Zolpidem extended-release|nightly administration of zolpidem extended-release
16162365|NCT01685073|Behavioral|MET/CBT|a standardized 12-week therapy consisting of motivational enhancement therapy (MET) and cognitive behavior therapy (CBT) for treating cannabis use disorders will be administered to all study participants
16162366|NCT01685060|Drug|LDK378|Ceritinib/LDK378 was supplied as 150 mg hard gelatin capsules and were administered orally, once-daily at a dose of 750 mg on a continuous dosing schedule (5 x 150 mg capsules).
16162367|NCT01685034|Biological|"Allergy immunotherapy (allergy shots)"|
16162368|NCT01685021|Drug|MOR00208 (formerly Xmab5574)|
16162369|NCT01685008|Drug|MOR00208 (formerly Xmab 5574)|
16162370|NCT01684995|Behavioral|Brief physician advice|Brief physician advice to quit smoking
16162371|NCT01684995|Drug|nicotine patch|nicotine patch
16162372|NCT01684995|Behavioral|Individually Tailored Behavioral Skills training|Individually tailored behavioral skills training for smoking cessation
16162373|NCT01684982|Device|everolimus eluting stent|experimental arm of a comparison between drug eluting stents
16162374|NCT01684982|Device|sirolimus eluting stent|control arm of a comparison between drug eluting stents
16162375|NCT01684969|Drug|Haloperidol|0.5 mg iv x one dose
16162376|NCT01684969|Drug|Placebo|0.5 mg iv , one dose
16162377|NCT01684956|Procedure|Intradermal injection|
16162378|NCT01684956|Procedure|Subcutaneous injection|
16162379|NCT01684943|Other|Multiplex pharmacokinetic profiling|
16162380|NCT01684943|Other|Continuous insulin monitoring|
16162381|NCT01684930|Drug|Beetroot Juice (Beet-It Stamina Shot) & Supervised Exercise Training|The beverage is high in inorganic nitrate and bottled and supplied by James White Drinks. This supplement will be used in conjunction with supervised exercise training.
16162382|NCT01684930|Other|Placebo Comparator Beverage (Beet-It Stamina Shot) & Exercise Training|The beverage is identical in look and taste to Beet-It Stamina Shot but with active ingredient removed. It is also bottled and supplied by James White Drinks. This placebo supplement will be used in conjunction with supervised exercise training.
16162383|NCT01684917|Behavioral|Metabolomic and Energy Intake Restriction|Metabolomic inquiry followed by a 12 week energy intake restriction. This study is part of a very large European study called EPIC. Only the results by Lee et al. 2016 have been presented here. The results of the study published by Cheung 2017 are from a different study. therefore the entries for the results are correct. For this particular study, participants were not randomly assigned to one of five different diets; red meat, fish, poultry, processed meat or a supplement and vegetarian option. In summary, both studies (lee and cheung) are considered as separate trials and results of the first phase where participants were assigned to one of five different diets, are reported separately. Unfortunately no different NCT number is available.
16162384|NCT01684904|Radiation|Proton radiation|
16162385|NCT01684891|Drug|RG1662|multiple doses of RG1662
16162386|NCT01684878|Drug|Gemcitabine (Chemotherapy)|Participants administered gemcitabine at a dosage of 1000 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Days 1 and 8 every 3 weeks.
16162387|NCT01684878|Drug|Paclitaxel (Chemotherapy)|Participants administered paclitaxel at a dosage of 80 mg/m^2 as 1 hour IV infusion on Days 1, 8 and 15 every 3 weeks.
16162388|NCT01684878|Drug|Pertuzumab|Participants administered pertuzumab 840 milligrams (mg) IV infusion on Day 1 of the first treatment cycle as a loading dose, followed by 420 mg on Day 1 of each subsequent 3 weekly cycle.
16162389|NCT01684878|Drug|Placebo|Participants administered pertuzumab matching placebo IV infusion on Day 1 of each 3 weekly cycle.
16162390|NCT01684878|Drug|Topotecan (Chemotherapy)|Participants administered topotecan at a dosage of 1.25 mg/m^2 as a 30 minute IV infusion daily on Days 1 to 5 every 3 weeks.
16162391|NCT01684865|Drug|Rituximab|Due to observational nature of the study protocol does not specify any dosing schedule for rituximab.
16162392|NCT01684852|Other|Medical device, drug-like|
16162393|NCT01684839|Device|Pedicled nerve flap|This nerve flap is a vascularized nerve graft
16162394|NCT01684826|Radiation|Angiographic run with new algorithm and low dose (50% dose)|Angiographic run with new algorithm and low dose (50% lower dose compared to Xper)
16162395|NCT01684826|Radiation|Angiographic run with predecessor algorithm and dose (100%)|Angiographic run with predecessor algorithm and dose (100% dose)
16162433|NCT01684540|Other|Medical Device, Drug-like|Ectoin Rhinitis Nasal Spray
16162396|NCT01684813|Drug|Prasugrel.|Patients in this group will receive a loading dose of 60 mg prasugrel (6 x 10 mg tablets) followed by at least dose of 10 mg prasugrel (1 x 10 mg tablet). Beyond the second day after PCI, these patients will receive double antiaggregation therapy according to their physician´s criteria.
16162397|NCT01684813|Drug|Clopidogrel|Patients in this group will receive the standard dose of clopidogrel, a daily dose of 75 mg. Beyond the second day post-PCI, these patients will receive double anti aggregation therapy according to their physician's criteria.
16162398|NCT01684800|Drug|A. Desmopressin 10 microgram|1 orally disintegrating tablet every night during study period
16162399|NCT01684800|Drug|B: Desmopressin 25 microgram|1 orally disintegrating tablet every night during study period
16162400|NCT01684800|Drug|C: Placebo|1 orally disintegrating tablet every night during study period
16162401|NCT01684787|Drug|Peginterferon alfa-2a + ribavirin in normal ALT|peginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily
16162402|NCT01684787|Drug|Peginterferon alfa-2a + ribavirin in elevated ALT|peginterferon alfa-2a 180 mcg/weekly ribavirin 1000-1200 mg/daily
16162403|NCT01684774|Drug|Bupivacaine|
16162404|NCT01684761|Biological|Tcelna|Autologous pool of myelin reactive T-cells (MRTC) expanded ex vivo with immunodominant epitopes selected from the three myelin antigens, MBP, PLP and MOG on a per subject basis. Attenuated by irradiation to prevent further proliferation before releasing product for administration.
16162405|NCT01684761|Biological|Placebo|2 ml of Tcelna excipients, prepared daily as individual doses and irradiated before releasing product for administration.
16162406|NCT01684748|Drug|Olmesartan medoxomil|Crossover intervention comparing antihypertensive medication to no drug intervention.
16162407|NCT01684722|Dietary Supplement|Vitamin D|Vitamin D3 (cholecalciferol), 2000 IU per day.
16162408|NCT01684722|Drug|Omega-3 fatty acids (fish oil)|Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
16162409|NCT01684722|Dietary Supplement|Vitamin D placebo|Vitamin D3 placebo
16162410|NCT01684722|Dietary Supplement|Fish oil placebo|Fish oil placebo
16162411|NCT01684709|Behavioral|Telemonitoring + self-management support|Weekly automated assessment calls with follow-up by a care manager and a CarePartner for 12 months. Baseline, 6 month, and 12 month follow-up
16162412|NCT01684696|Behavioral|Virtual experience|
16162413|NCT01684696|Behavioral|Videos|
16162414|NCT01684683|Drug|Theophylline|Theophylline 0.1 bid
16162415|NCT01684683|Drug|Placebo(for Theophylline)|Starch tablet manufactured to Theophylline 100mg (Theophylline Stained-Release Tablet)
16162416|NCT01684670|Behavioral|Speech sessions|Subjects will be instructed to use clear speech and increased effort when speaking.
16162417|NCT01684657|Drug|Asenapine|This is an atypical antipsychotic that blocks dopamine and increase the serotonin level.
16162418|NCT01684644|Behavioral|New Forest Parenting Programme|
16162419|NCT01684644|Behavioral|Treatment as usual|
16162420|NCT01684631|Device|Total Hip arthroplasty|
16162421|NCT01684618|Procedure|Cerebral NIRS Oximetry + CPAP|CPAP flow pressure is increased for 5 minutes then 15 minutes with CPAP pressure at baseline. Repeated once
16162422|NCT01684605|Drug|NESP 60μg|Administrated NESP 60μg once intravenously
16162423|NCT01684605|Drug|CKD-11101 60μg|Administrated CKD-11101 60μg once intravenously
16162424|NCT01684592|Behavioral|Phone-based postpartum continuing care|PPCC Counselors will make initial contact with participants in the experimental group at 36 weeks gestation (i.e., one week prior to full-term), will call again within one week after the baby's birth, and eight additional times over the course of the first six months postpartum. The PPCC protocol will be developed based on the 5 A's (standard of care during pregnancy) and the Recovery Management Checkup model where relapse is expected and efforts are made to take a more proactive approach to identify women who are having cravings or have relapsed and re-intervene with them as soon as possible to assist them in regaining smoking abstinence. Women in the experimental group will also have the option of calling the PPCC line 24 hours a day, 7 days a week.
16162425|NCT01684592|Behavioral|Standard care|All women will receive the standard of care approach (5 A's and referral to a 24/7 quit line postpartum) from MWC during pregnancy. The 5 A's brief intervention was modified by American College of Obstetricians and Gynecologists (ACOG) for use with pregnant women and is recommended to help pregnant women quit smoking. It includes the following steps: Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, and Arrange follow-up.
16162426|NCT01684579|Behavioral|Resistance Exercise|Resistance exercise will be performed 2 days per week for 18 weeks. The resistance training protocol will follow the Resistance Training Strategies for Individuals With Cancer (RTSFIC). The goals will be to keep intensity levels low at the outset (having lighter weights and more reps) and progress slowly and safely. Training prescriptions will be modified based on the training level of the patients and their progress.
16162427|NCT01684579|Behavioral|Aerobic Exercise|A 20-week aerobic walking exercise program will be developed for each participant based on results of initial exercise testing and prescribed to be done 5 or more days per week designed to progress from moderate exercise intensity, (50-70% maximum heart rate), to vigorous exercise intensity (75-85% maximum heart rate). Maximum heart rate (HR max) will be determined as the peak heart rate achieved during initial cardiopulmonary exercise screening. Heart rate during exercise will be monitored by participants using wrist monitors, already available through TREC Program. Patient progress will also be evaluated using a six minute walk test (6MWT), which will be conducted at TGP at baseline, 6, 12 and 18 weeks and, after completion of the intervention.
16162428|NCT01684579|Behavioral|Behavioral Group Counseling|The psychosocial component of the 20-week exercise program includes a 1 ½ hour support group offered prior to one of the weekly exercise classes.
16162429|NCT01684566|Device|episil(R)|episil® is a lipid-based liquid that spreads onto mucosal surfaces and transforms into a protective, strongly bioadhesive FluidCrystal® film after intraoral administration.
16162430|NCT01684566|Other|Oral hygiene procedures|Oral hygiene by using toothbrush, toothpaste, lip balm and dental floss (if available)
16162431|NCT01684553|Behavioral|Slow eating condition|The subjects were asked to eat their meal slowly during the slow eating condition
16162432|NCT01684553|Behavioral|Fast eating condition|The subjects were asked to eat their meal quickly during the fast eating condition
16162435|NCT01684527|Other|Respiratory secretions obtained|
16162436|NCT01684514|Device|Confocal laser endomicroscopy|"Within recent years a new approach was introduced, wherein the microscopic structures of the intestinal mucous can be evaluated continuously in vivo during the endoscopic procedure. The technique is called confocal laser endomicroscopy (CLE). CLE functions by means of a laser device, which is inserted or build into an endoscope, and used as an illuminator of the lining of a small area and at a precise depth. The tissue is first added with fluorescence by intravenous administration. The reflection of the mucosa is captured in a focused area and magnified by which a two-dimensional image of mucosal microscopic structures is formed. This provides us with an optical biopsy, which can be compared with a similar microscopic image."
16162437|NCT01684488|Behavioral|YRI|The YRI brings together six empirically-supported practice elements shown to be efficacious across different mental health interventions, as well as methods intended to socialize youth and improve self-efficacy. Practice elements address the broad scope of problems evidenced in Sierra Leonean war-affected youth and enhance the YRI's pacing, which progresses through three phases traditionally used in trauma treatments (stabilization, integration, connection). The weekly intervention takes place over 10 sessions lasting approximately one hour and a half. Groups are divided by gender and age. Each group is paired with two interventionists of the same gender.
16162438|NCT01684488|Other|EducAid educational programming|EducAid is a charitable trust that provides free year-round education to over 1,500 youth, along with food, medicine, and shelter when needed. EducAid's education model aims to improve academic knowledge, self-efficacy, and attitudes toward school. Additionally, it aims to nurture hope for the future and a sense of normalcy through interactions with teachers, mentors, and peers.
16162439|NCT01684475|Drug|CJH1 (CLR4001)|
16162440|NCT01684462|Biological|Human Serum Albumin 20|Human Serum Albumin 20% 100cc albumin 1.25g/kg up to 100g (500ml) intravenously infused over 4~8h, commencing within 12 hours of stroke onset
16162441|NCT01684462|Drug|0.9 % Normal Saline|Infusion of 100 mL of 0.9% Normal Saline ( equivalent volume of Albumin ) over 4~8h, commencing within 12 hours of stroke onset
16162442|NCT01684449|Drug|Gemcitabine + Rapamycin|"Gemcitabine + rapamycin at recommended dose of Phase 1. Recommended dose is defined as, the dose one level below of the (MTD). Being MTD, the dose of the cohort in which a maximum of one patient of 6 has presented dose-limiting toxicity (DLT).
~Every three weeks until disease progression or unacceptable toxicity. The treatment will last for 6 cycles if there is not progression or intolerable toxicity.
~Additionally, there will be a pharmacokinetic study in a minimum of 9 patients treated with the drug combination."
16162443|NCT01684436|Device|Punctal Plug|Punctal plugs inserted into the study eye on Day 1.
16162444|NCT01684423|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Subjects were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) IR tablet once daily under fed conditions for 30 days.
16162445|NCT01684423|Drug|Active comparator|Subjects received comparator as per standard of care. The dosage given was to be adjusted based on the individual body weight (low molecular weight heparin, fondaparinux) or international normalized ratio (INR) adjusted (vitamin K antagonist).
16162446|NCT01684423|Drug|Rivaroxaban (BAY59-7939) suspension|Subjects aged were administered with age- and body weight-adjusted oral dose of rivaroxaban (BAY59-7939) suspension under fed conditions twice daily.
16162447|NCT01684410|Biological|Alpha-1 HC 100 mg|Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma. Alpha-1 HC 100 mg inhaled once daily for 21 days for a total of 21 inhaled treatments.
16162448|NCT01684410|Biological|Placebo|Phosphate Buffer Saline with Polysorbate (placebo) composed of the same elements listed for Alpha-1 HC, minus the 50 mg/mL of Alpha-1 HC. Placebo inhaled once daily for 21 days for a total of 21 inhaled treatments.
16162449|NCT01684410|Biological|Alpha-1 HC 200 mg|Alpha-1 HC is a sterile, liquid preparation of purified alpha1-proteinase inhibitor prepared from pooled human plasma. Alpha-1 HC 200 mg inhaled once daily for 21 days for a total of 21 inhaled treatments.
16162450|NCT01684397|Biological|Bevacizumab|Given IV
16162451|NCT01684397|Other|Laboratory Biomarker Analysis|Correlative studies
16162452|NCT01684397|Drug|Pazopanib Hydrochloride|Given PO
16162453|NCT01684397|Other|Pharmacological Study|Correlative studies
16162454|NCT01684384|Radiation|Functional Respiratory Imaging|HRCT scan at FRC and TLC as taken during an episode of exacerbation and after recovering.
16162455|NCT01684371|Other|Two oily solutions (Blue Dotted and Orange Dotted Elmore Oils)|Thirty participants received Blue Dotted Elmore Oil and another thirty received the Orange dotted Elmore Oil, they applied the oils three times daily on the affected knees for four weeks and stopped usage on the fifth week (flush out period) and on the 6 week, the two group switched to Orange and Blue Elmore Oil respectively. All throughout applications, they filled out their diaries to indicate changes in their mobility, moods, feeling of well being and ability to do their daily work at home or at work every week.
16162456|NCT01684358|Device|Sino-implant (II)|Sino-implant (II) (Shanghai Dahua Pharmaceutical Co, Ltd.; Shanghai, China), a contraceptive implant with two rods each of which contain 75 mg of levonorgestrel.
16162457|NCT01684345|Drug|Placebo|Solution for subcutaneous injection
16162458|NCT01684345|Drug|Dose 1 gevokizumab|Solution for subcutaneous injection
16162459|NCT01684345|Drug|Dose 2 gevokizumab|Solution for subcutaneous injection
16162460|NCT01684332|Other|Strawberry Jam|
16162461|NCT01684319|Dietary Supplement|Formula milk free of cow's milk protein|
16162462|NCT01684319|Dietary Supplement|Placebo|Infant formula milk
16162463|NCT01684306|Drug|Modafinil|Study subjects received, in a double blind fashion, either a single dose (100 mg) of modafinil or a placebo pill identical to the drug.
16162464|NCT01684306|Drug|Placebo|Study subjects received, in a double blind fashion, either a single dose (100 mg) of modafinil or a placebo pill identical to the drug.
16162465|NCT01684293|Behavioral|Occupational therapy-based cognitive rehabilitation|Occupational therapy-based cognitive rehabilitation
16162466|NCT01684293|Behavioral|Psychoeducation/games|Psychoeducation/games
16162467|NCT01684280|Genetic|gender|Paired samples of abdominal subcutaneous and intrabdominal omental adipose tissue were obtained from men and women who underwent bariatric surgery.
16162468|NCT01684267|Device|Robotic Gait Rehabilitation (RGR) Trainer|
16162555|NCT01683526|Device|Video laryngoscopy (Glidescope)|
16241674|NCT01072214|Drug|pazopanib|gw786034
16162469|NCT01684241|Biological|RBL001/RBL002|Each participant will receive 8 repeated intranodal administrations of RBL001 and RBL002 during a time frame of 43 to 51 days.
16162470|NCT01684215|Drug|PD-0332991|PD-0332991 (100 mg or 125 mg) will be orally administered once a day for 3 weeks followed by 1 week off treatment, in the morning on an empty stomach. Dose reduction of PD-0332991 by one (100 mg) or two (75 mg) dose level is permitted depending on treatment related toxicity.
16162471|NCT01684215|Drug|PD-0332991|PD-0332991, 125 mg, will be orally administered with food once a day for 3 weeks followed by 1 week off treatment. PD-0332991 will be administered once a day together with letrozole. Dose reduction of PD-0332991 by one (100 mg) or two (75 mg) dose level is permitted depending on treatment related toxicity.
16162472|NCT01684215|Drug|letrozole|Letrozole, 2.5 mg, will be orally administered once a day in continuous daily dosing together with PD-0332991. Dose reduction of letrozole is not permitted, but dosing interruptions for letrozole-related toxicity are allowed as per investigator's medical judgement.
16162473|NCT01684215|Drug|PD-0332991|PD-0332991, 125 mg, will be orally administered with food once a day for 3 weeks followed by 1 week off treatment. PD-0332991 will be administered once a day together with letrozole. Dose reduction of PD-0332991 by one (100 mg) or two (75 mg) dose level is permitted depending on treatment related toxicity.
16162474|NCT01684215|Drug|letrozole|Letrozole, 2.5 mg, will be orally administered once a day in continuous daily dosing together with PD-0332991. Dose reduction of letrozole is not permitted, but dosing interruptions for letrozole-related toxicity are allowed as per investigator's medical judgement.
16162475|NCT01684202|Drug|OPC-41061|orally administered at 3.75, 7.5, 15, or 30 mg once daily after breakfast for up to 11 days.
16162476|NCT01684189|Other|Patient registry|Patient registry without study intervention
16162477|NCT01684176|Behavioral|Complex tailored intervention|
16162478|NCT01684176|Behavioral|Usual care|
16162479|NCT01684163|Drug|GLYX-13 5 mg/kg|Intravenous administration of 5 mg/kg into arm.
16162480|NCT01684163|Drug|GLYX-13 10 mg/kg|Intravenous administration of 10 mg/kg into arm.
16162481|NCT01684163|Drug|Placebo|Intravenous administration of normal saline into arm.
16162482|NCT01684150|Drug|EPZ-5676|MLL-r and MLL-PTD 28-day continuous IV infusion of each 28-day cycle. Number of cycles: until disease progression or unacceptable toxicity develops.
16162483|NCT01684137|Dietary Supplement|Joalis Bambi Analerg|
16162484|NCT01684137|Dietary Supplement|Joalis Bambi Bronchi|
16162485|NCT01684137|Dietary Supplement|Placebo|Sugar pill manufactured to mimic Joalis Bambi Analerg
16162486|NCT01684137|Dietary Supplement|Placebo|Sugar pill manufactured to mimic Joalis Bambi Bronchi
16162487|NCT01684124|Other|conservative O2 therapy|target lower O2 saturation
16162488|NCT01684124|Other|standard care|
16162489|NCT01684111|Drug|BIBF 1120|2 x 150 mg capsules, oral, daily (Start dose)
16162490|NCT01684111|Drug|Vinorelbine|25 mg/m2 i.v. on day 1 and 8 (three-week cycle)
16162491|NCT01684098|Drug|Tc 99m EC20|
16162492|NCT01684085|Behavioral|Explanation encouraging sleep|An explanation will be given about sleep, encouraging the patient to sleep - lorazepam 1mg will be offered to promote sleep.
16162493|NCT01684085|Behavioral|Explanation discouraging sleep|An explanation about sleep will be given, discouraging the patient from sleeping in the first night after the traumatic event.
16162494|NCT01684085|Drug|Lorazepam|Lorazepam 1 mg
16162495|NCT01684072|Biological|vaccine without gelatin|use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection
16162496|NCT01684072|Biological|vaccine with gelatin|use the upper arm flank deltoid muscle adheres to stick cohere place the skin after 75% ethyl alcohol disinfection the hypodermic injection
16162497|NCT01684059|Dietary Supplement|zinc sulfate|every participant took two capsules of zinc sulfate per day for three months (each one 220mg)
16162498|NCT01684046|Device|Opti-Free® PureMoist® MPDS|
16162499|NCT01684046|Device|RevitaLens MPDS|
16162500|NCT01684046|Device|Habitual Contact Lenses|Silicone hydrogel contact lenses per participant's habitual brand, prescription, and replacement schedule worn on a daily wear basis for at least 8 hours a day, 5 days a week for the duration of the study. During the washout period, the contact lenses were worn on a daily disposable basis.
16162501|NCT01684033|Device|Opti-Free® PureMoist® MPDS|
16162502|NCT01684033|Device|Biotrue™ MPS|
16162503|NCT01684033|Device|Habitual contact lenses|Silicone hydrogel contact lenses per participant's habitual brand, prescription, and replacement schedule worn on a daily wear basis for at least 8 hours a day, 5 days a week for the duration of the study. During the washout period, the contact lenses were worn on a daily disposable basis.
16162504|NCT01684020|Biological|ARTISS human fibrin sealant|
16162505|NCT01684007|Device|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]|Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient
16162506|NCT01684007|Device|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1|Multifocal IOL implanted for long-term use over the lifetime of the cataract patient
16162507|NCT01683994|Drug|Cabozantinib|Assigned dose given daily during each 21 day cycle. Treatment may continue until disease progression or intolerable toxicity.
16162508|NCT01683994|Drug|Docetaxel|75mg/m^2 intravenous (IV) over approximately 60 minutes on cycle 1 day 1 and repeated every 21 days until disease progression or intolerable toxicity.
16162509|NCT01683994|Drug|Prednisone|5 mg by mouth (PO) twice a day during each 21 day cycle until disease progression or intolerable toxicity.
16162510|NCT01683981|Drug|L-Citrulline Malate|3 gr per day, oral, for 2 weeks
16162511|NCT01683955|Drug|Transexamic Acid|Topical tranexamic acid (2g/100mL 0.9% saline)
16162512|NCT01683955|Drug|Placebo|100mL 0.9% sterile saline
16162552|NCT01683539|Behavioral|The Thinking Skills for Work Program|The Thinking Skills for Work includes assessment of cognitive strengths and weaknesses and their relationship with work history, computerized cognitive practice, compensatory strategy training, and integration of cognitive and work services.
16162553|NCT01683539|Behavioral|The Cognitive Skills for Work Program|The Cognitive Skills for Work includes assessment of cognitive strengths and weaknesses and their relationship with work history, compensatory strategy training, and integration of cognitive and work services.
16162554|NCT01683526|Procedure|Direct laryngoscopy|
16162513|NCT01683929|Other|glucose|"The participants will report to the lab after an overnight fast. Their BMI, HR and BP will be measured. An IV catheter will be inserted into the brachial vein and the participants will rest for half an hour. Participants will drink A beverage containing 75 gram glucose (oral glucose tolerance test (OGTT / GTT) All the participants will be checked for level of: insulin, glucose, adrenalin norepinephrine, dopamine, catecholamines, cortisol, ghrelin, leptin, IGF-1 GH and other related hormones- before consuming the drink (time 0), and at 30, 60, 120, 180 minutes after.
~The participants HR & BP will be monitored throughout the examination + 1 hour after.
~In addition, the participants will be asked to complete a- 24 hr food questionnaire."
16162514|NCT01683929|Other|sweetner|"The participants will report to the lab after an overnight fast. Their BMI, HR and BP will be measured. An IV catheter will be inserted into the brachial vein and the participants will rest for half an hour. Participants will drink A beverage containing artificial sweetened drink. All the participants will be checked for level of: insulin, glucose, adrenalin norepinephrine, dopamine, catecholamines, cortisol, ghrelin, leptin, IGF-1 GH and other related hormones- before consuming the drink (time 0), and at 30, 60, 120, 180 minutes after.
~The participants HR & BP will be monitored throughout the examination + 1 hour after.
~In addition, the participants will be asked to complete a- 24 hr food questionnaire."
16162515|NCT01683877|Procedure|FloSeal application|After laparoscopic ovarian cystectomy, hemostasis will be performed using FloSeal (1 vial of FloSeal 5mL per unilateral ovarian cystectomy)
16162516|NCT01683877|Procedure|Electrocautery|After laparoscopic ovarian cystectomy, hemostasis will be performed using electrocautery
16162517|NCT01683864|Drug|positive cytology with HIPEC|HIPEC with mytomycin and cisplatin
16162518|NCT01683851|Device|Isolite System|A type of isolation system used in dentistry. It protects soft tissues, and also has a mouth prop, which helps keep mouth open.
16162519|NCT01683838|Drug|Fampridine-SR|25mg bid (twice daily)
16162520|NCT01683838|Drug|Placebo|Placebo
16162521|NCT01683825|Drug|F-18 florbetapir PET|Cardiac PET images will be obtained following injection of F-18 labeled Florbetapir (Trade Name: Amyvid)
16162522|NCT01683812|Device|Cranial Cup|Study participants with dolichocephaly will be treated with the Cranial Cup for a minimum 12 hours per day.
16162523|NCT01683799|Behavioral|Cognitive Behavioral Therapy for Insomnia|6-week behavioral treatment for insomnia
16162524|NCT01683786|Drug|Pegintron + Riba|Pegylated IFN-α2b at 1.5 µg/kg of body weight/week and ribavirin 800~1400 mg/day
16162525|NCT01683773|Biological|AERAS-402|Intramuscular needle injection 1x10^11 vp
16162526|NCT01683773|Biological|MVA85A|Intradermal needle injection 1x10^8 pfu
16162527|NCT01683760|Drug|Fluconazole|Prophylactic fluconazole administration in VLBW infants
16162528|NCT01683747|Drug|Tranexamic Acid|
16162529|NCT01683747|Drug|Control Intervention (Carrier fluid only)|
16162530|NCT01683708|Dietary Supplement|Symbiotic therapy|Patients randomized into the Symbiotic group received Prebiotic® in a dose of one sachet twice a day for at least 1 week preoperatively. Postoperatively the medication was reintroduced as tolerated, and continued until discharge from hospital. One 4,5 gr sachet of Prebiotic® contains at least 1010 living Bifidobacterium bifidum, 1010 living Streptococcus Thermophilus, 1010 living Streptococcus Salivarius, 3 109 Lactobacillus Acidophilus, 1010 living Lactobacillus Casei, 1010 living Lactobacillus bulgaricus and galactooligosaccharides (4,5 gr).
16162531|NCT01683695|Drug|AMG 557|AMG 557 will be administered as subcutaneous injections in the anterior abdomen of the subjects.
16162532|NCT01683695|Drug|Matching Placebo|Placebo will be administered as subcutaneous injections in the anterior abdomen of the subjects.
16162533|NCT01683682|Drug|BIBF 1120|2 x 150 mg capsules, oral, daily (Start dose)
16162534|NCT01683682|Drug|Vinorelbine|25 mg/m2 i.v. on day 1 and 8 (three-week cycle)
16162535|NCT01683682|Drug|Carboplatin|AUC 5 i.v. on day 1 (three-week cycle)
16162536|NCT01683669|Other|Noisy-PSV 1|Noisy-PSV 1: different levels of variable pressure support (PS) will be randomized: a) PS variability equal to 0%, b) PS variability equal to 45%, c) PS variability equal to 90%.
16162537|NCT01683669|Other|Noisy-PSV 2|Noisy-PSV 2 : different levels of variable Pressure Support (PS) will be randomized: a) PS equal to Baseline and variability 0%; b) PS equal to Baseline and variability set in order achieve an increase or decrease of pressure of 5 cmH2O; c) PS equal to Baseline - 5 cmH2O and variability 0%; d) PS equal to Baseline - 5 cmH2O and set in order achieve an increase or decrease of pressure of 5 cmH2O.
16162538|NCT01683656|Drug|niacin/laropiprant|
16162539|NCT01683656|Drug|Placebo|Procedures for the manufacturing and testing of the placebo are compiled in the IMP/study drug dossier and comply with local regulatory requirements (by GMP certified manufacturer).
16162540|NCT01683643|Behavioral|SBIRT|Screening, brief intervention, and referral to treatment.
16162541|NCT01683643|Behavioral|Control Group|Control subjects will receive only their risk score and informational materials regarding the health risks of substance use.
16162542|NCT01683617|Behavioral|Coping skills and relaxation training with new technologies|
16162543|NCT01683617|Behavioral|Traditional coping skills and relaxation training|
16162544|NCT01683604|Other|Observational study|
16162545|NCT01683591|Procedure|High-resolution impedance manometry test|The test was performed as general guideline for high-resolution impedance manometry test. The parameter was obtained and analyzed using the Chicago classification for the liquid swallows with Takasaki's modification for pharyngeal function monitoring. Swallowing pattern and aspiration risk were defined using real-time assessment of high-resolution impedance manometry test.
16162546|NCT01683578|Other|Variable Ventilation|
16162547|NCT01683565|Drug|LCPUFA oil supplement|"2.5mL per day for 90 days
~Daily Dose: EPA (338mg) + DHA (225mg) + GLA (83mg) + OA (200mg)"
16162548|NCT01683565|Other|Canola Oil Placebo|2.5mL per day for 90 days
16162549|NCT01683552|Drug|Aprepitant|125 mg on day 1; 80 mg on day 3; 80 mg on day 5
16162550|NCT01683552|Drug|Prednisone|In the refractory group (VAS score ≥7), Aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on day 5) is administered after at least one week of standard systemic treatment (prednisone 25 mg/die and/or fexofenadine 180 mg/die),
16162551|NCT01683552|Drug|Fexofenadine|In the refractory group (VAS score ≥7), Aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on day 5) is administered after at least one week of standard systemic treatment (prednisone 25 mg/die and/or fexofenadine 180 mg/die)
16162686|NCT01682512|Drug|BI 695500|
16162556|NCT01683513|Drug|GnRh agonist +1500E hCG|ovulation induction with GnRh agonist and 1500E hCG one hour after egg retrieval
16162557|NCT01683500|Device|shock wave therapy with Modulith SLK (Storz)|Three sessions with shock wave therapy, interval of one week.
16162558|NCT01683487|Procedure|Observation|Observational study only, no intervention.
16162559|NCT01683474|Device|Venus MedTech Aortic Valve Prosthesis|Percutaneous implantation of aortic valve of Venus-A
16162560|NCT01683461|Behavioral|Enhanced Counseling|Women in the enhanced counseling arm receive the following intervention package: a video prior to their HIV pre-test counseling session that prepares them for decisions they will have to make regarding HIV testing and PMTCT participation, a pre-test counseling session and post-test counseling session with their nurse midwife/counselor, and two additional post-test counseling sessions with the same nurse midwife at 6 and 10 weeks postpartum. Women in the enhanced counseling arm also have access to ongoing support groups and legal support if needed at the clinic.
16162561|NCT01683461|Behavioral|Standard of Care|Women in the standard of care arm receive HIV pre and post-test counseling at their first antenatal visit. The counseling provided to them adheres to international guidelines for HIV counseling and testing developed by US CDC and the World Health Organization.
16162562|NCT01683435|Other|HBA binding assay|HBA binding assay will be preformed on the discarded portion of semen analysis used for IVF.
16162563|NCT01683422|Radiation|Proton, Gemcitabine, Erlotinib, Capecitabine|"Gemcitabine 1000 mg/m2 iv, days 1, 8, 15, 29, 36 and 43 Erlotinib 100 mg po qd days 1-43 Capecitabine 825mg/m2 po bid M-F, starting on day 1 of proton therapy until proton therapy completed.
~Post-proton chemotherapy: To be started in 4 to 6 weeks after completion of proton chemotherapy. Oxaliplatin 130 mg/m2 po bid on days 2 to 15 for 14 days. The CapOx regimen (Capcitabine plus Oxaliplatin) is repeated every 3 weeks for 4 cycles."
16162564|NCT01683422|Radiation|Proton Radiation|
16162565|NCT01683409|Drug|Baricitinib|Administered orally
16162566|NCT01683409|Drug|Placebo|Administered orally
16162567|NCT01683396|Drug|Placebo|Solution for subcutaneous injection
16162568|NCT01683396|Drug|gevokizumab|Solution for subcutaneous injection
16162569|NCT01683383|Device|Device (servo-regulated cooling)|Subjects in Arm 2 will be placed on cooling blanket connected to the Tecotherm Neo (Inspiration Healthcare LTD UK). Temperature will be monitored continuously and servo-regulated using a rectal temperature probe.
16162570|NCT01683383|Other|Control (standard practice)|Subjects in Arm 1 will receive passive or active cooling as per center practice with rectal temperatures being recorded every 15 minutes.
16162571|NCT01683357|Procedure|Hepatectomy|"Intraoperative ultrasound (IOUS) criteria for tumor-vessel relations let maximizing the preservation of the hepatic vascular skeleton. Contact between colorectal liver metastases and a major intrahepatic vessel is not by itself a criteria for vessel resection: tumor exposure is not contraindicated.
~If resection of a hepatic vein (HV), resection of the liver parenchyma drained by that vein is considered or not based on color-flow IOUS findings (hepatofugal blood flow in the feeding portal branch, evidence or not of communicating veins between adjacent HVs, evidence or not of accessory HVs).
~Parenchymal transection is performed under intermittent clamping by the Pringle maneuver. Drains are always inserted and a chest tube is inserted in patients undergoing thoracophrenolaparotomy."
16162572|NCT01683331|Drug|Insulin treatment for hyperglycemia|
16162573|NCT01683318|Procedure|Thermal Pulsation therapy|
16162574|NCT01683292|Drug|Inhaled VR040|
16162575|NCT01683292|Drug|Placebo for VR040|Placebo arm
16162576|NCT01683279|Biological|Autologous CD19 CAR+ EGFTt + T cells|Autologous T cell modified to express a CD19 specific CAR and a truncated EGFRt tag
16162577|NCT01683266|Drug|HOE901-U300 (Insulin glargine new formulation)|
16162578|NCT01683266|Drug|Lantus (Insulin glargine)|
16162579|NCT01683253|Drug|Levodopa/Carbidopa(200mg/50mg)|
16162580|NCT01683253|Drug|Dopaminergic Agonists|Treated for at least 6 months after diagnosis of Parkinson's Disease.
16162581|NCT01683240|Device|cholangioscopy (Frimberger)|cholangioscopy with Frimberger duodenoscope system by the company of Karl Storz GmbH
16162582|NCT01683227|Behavioral|Screening/motivational drug intervention|Screening and brief motivational intervention delivered in the ER to reduce drug use
16162583|NCT01683227|Behavioral|Motivational placebo intervention|Screening and brief motivational intervention delivered in the ER to reduce driving and traffic risk
16162584|NCT01683201|Procedure|Functional exercise class|Functional exercise class running twice weekly for six weeks from week 12 to week 18
16162585|NCT01683201|Procedure|usual care group|Usual care group adhere to post operative instructions given on discharge from hospital
16162586|NCT01683188|Drug|vemurafenib + HD IL-2|
16162587|NCT01683175|Drug|Erlotinib|
16162588|NCT01683175|Drug|cis-platinum|
16162589|NCT01683175|Drug|Vinorelbine|
16162590|NCT01683162|Drug|ClinOleic|the lipid of all-in-one, 0.5-3.5g/kg.d
16162591|NCT01683162|Drug|Lipofundin|the lipid of all-in-one, 0.5-3.5g/kg.d
16162592|NCT01683162|Drug|Intralipid|the lipid of all-in-one, 0.5-3.5g/kg.d
16162593|NCT01683149|Drug|Topotecan|Topotecan will be given by mouth as outlined in treatment arm.
16162594|NCT01683149|Drug|Sorafenib|Sorafenib will be given by mouth as outlined in treatment arm.
16162595|NCT01683136|Device|HBDL-coil Repetitive Deep Transcranial magnetic stimulation (rdTMS)|"on the first day subjects will be randomized to receive sham stimulation or real stimulation. subject who received real stimulation on the first day will receive sham stimulation on the second day. Likewise, Subjects who received sham stimulation on the first day will receive real stimulation on the second day. After receiving stimulation subjects will perform a facemorph task which evaluates their empathic capabilities.
~From the third treatment all subjects will recive a real stimulaitiobn: a session of rdTMS includes 4 cycles of 5 minutes of stimulation at a frequency of 10 Hz to the supplementary motor cortex and then a 20 seconds recess.each subject would undergo 5 sessions a week for 4 weeks"
16162596|NCT01683110|Drug|cabozantinib|
16162597|NCT01683097|Other|Standardized explanation|Standardized explanation provided on code status, advance directives and end of life care
16162598|NCT01683084|Drug|Telmisartan|
16162599|NCT01683084|Drug|Placebo|
16162600|NCT01683071|Drug|Placebo|Normal saline 20 mL as single-injection femoral nerve block prior to total knee arthroplasty
16162687|NCT01682512|Drug|Rituxan®|
16162601|NCT01683071|Drug|EXPAREL 67 mg|5 mL EXPAREL expanded with 15 mL normal saline as single-injection femoral nerve block prior to total knee arthroplasty
16162602|NCT01683071|Drug|EXPAREL 133 mg|10 mL EXPAREL expanded with 10 mL normal saline as single-injection femoral nerve block prior to total knee arthroplasty
16162603|NCT01683071|Drug|EXPAREL 266 mg|20 mL EXPAREL as single-injection femoral nerve block prior to total knee arthroplasty
16162604|NCT01683058|Drug|Aripiprazole IM Depot|Aripiprazole IM Depot 400 mg or 300 mg
16162605|NCT01683045|Device|The Estech COBRA® Surgical System|The Estech COBRA® Surgical System has been designed to create epicardial and endocardial lesions on the heart using temperature controlled radiofrequency (TCRF) ablation with the Estech COBRA surgical probes. Temperature control provides a meaningful endpoint, maintaining tissue at safe yet effective temperatures to produce the desired lesion set. Internal probe cooling and advanced suction helps to ensure reproducible transmural (full-thickness) endocardial or epicardial lesions.
16162606|NCT01683032|Drug|MPH|a capsule containing 20 mg
16162607|NCT01683019|Device|NeoSync EEG Synchronization Therapy|Generate low-energy sinusoidal magnetic field above the scalp with frequency equal to the subject's intrinsic alpha frequency (IAF). Treatment is 30 minutes, administered 5 days per week for 4 weeks.
16162608|NCT01683019|Device|Sham NeoSync EEG Synchronization Therapy|A device that looks and sounds similar to the active treatment, but no magnetic field is generated.
16162609|NCT01683006|Drug|Rocuronium|"Continuous application of Rocuronium (0.5 mg/kg body weight/hour).
~Bolus application of placebo in case of shivering."
16162610|NCT01683006|Drug|Placebo|"Continuous application of placebo during therapeutic hypothermia.
~Bolus application of Rocuronium (0.5 mg/kg body weight) in case of shivering."
16162611|NCT01682993|Other|Topography guided Excimer Laser treatment and Corneal Cross Linking|A topography guided excimer laser treatment will be performed prior to CCL in one session.
16162612|NCT01682993|Other|Corneal Cross Linking|A standard corneal cross linking procedure will be performed in this arm.
16162613|NCT01682980|Other|Strength training|The strength training will be delivered 2-3 times per week for 12 weeks, 5-8 repetitions maximum in 3 series. The patients must warm up 5 minutes on an ergometer cycle. The following muscle groups will be trained: Quadriceps and hamstrings, hip muscles (abductors and extensors), calf muscles. A home exercise program will be delivered including one leg exercises and balance exercises. Progression will follow a 2+ principle. For instance, when the study participant is able to perform 2 more repetitions, more loads are required.
16162614|NCT01682980|Other|Aerobic exercise|The aerobic exercise program include ergometer cycling for at least 45 minutes 2-3 times a week on 75-80% of max heart rate will be required.
16162615|NCT01682954|Behavioral|Lifestyle counseling|16-week nutrition, physical activity and behavioral intervention
16162616|NCT01682941|Dietary Supplement|Arm I Soy Bread|On day 0 or day 70 pharmacokinetic study of isoflavones over 24 hours will follow after consumption of 2 slices of soy bread. Afterwards 2 slices of soy bread/day will be consumed for 56 days and isoflavone metabolites will be assessed in urine at days 0, 28, 56, 70, 98, and 126.
16162617|NCT01682941|Dietary Supplement|Arm II Soy-Almond Bread|On day 0 or day 70 pharmacokinetic study of isoflavones over 24 hours will follow after consumption of 2 slices of soy-almond bread. Afterwards 2 slices of soy-almond bread/day will be consumed for 56 days and isoflavone metabolites will be assessed in urine at days 0, 28, 56, 70, 98, and 126.
16162618|NCT01682928|Drug|IV/Oral Hydration and Bedrest|"Maternal BP (sitting)
~Pulse Pressure
~Pulse
~Urine Specific Gravity BID
~Fetal Heart Rate
~Maternal Body Weight US Procedures
~AC/EFW
~Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})
~Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})
~AFI (Baseline, day 3, 7 {or Discharge})
~ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:
~1 Liter Water PO over 2 hours
~1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\hr for duration of the study participation
~Strict I/O's
~Vital signs"
16162619|NCT01682928|Other|Hydrotherapy|"Maternal BP (sitting)
~Pulse Pressure
~Pulse
~Urine Specific Gravity BID
~Fetal Heart Rate
~Maternal Body Weight US Procedures
~AC/EFW
~Umbilical Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})
~o 1 hour +/- 30 minutes after submersion therapy
~Uterine Artery Doppler Flow (Baseline, day 3, 7 {or Discharge})
~o 1 hour +/- 30 minutes after submersion therapy
~AFI (Baseline, day 3, 7 {or Discharge}) o 1 hour +/- 30 minutes after submersion therapy
~ALL ITEMS ABOVE MUST BE COMPLETED BEFORE:
~1 Liter Water PO over 2 hours
~1 Liter IV Fluid Bolus (NS) then titrated to 75 ml\hr for duration of the study participation
~Strict I/O's
~Vital signs
~HYDROTHERAPY TWICE DAILY FOR 3-7 DAYS o Blood pressure, pulse, pulse pressure, body weight, and fetal heart rate before and after submersion therapy"
16162620|NCT01682902|Drug|Faster-acting insulin aspart|Administration: Subcutaneous infusion. The subjects will remain on their own pump during the trial. Subjects will have blinded continuous glucose monitoring (CGM) throughout the trial (3 treatment periods of 14 days) and meal tests consisting of a standardised breakfast (liquid meal) will be performed on the 14th day of each treatment period.
16162621|NCT01682902|Drug|Faster-acting insulin aspart|Administration: Subcutaneous infusion. The subjects will remain on their own pump during the trial. Subjects will have blinded continuous glucose monitoring (CGM) throughout the trial (3 treatment periods of 14 days) and meal tests consisting of a standardised breakfast (liquid meal) will be performed on the 14th day of each treatment period.
16162622|NCT01682902|Drug|insulin aspart|Administration: Subcutaneous infusion. The subjects will remain on their own pump during the trial. Subjects will have blinded continuous glucose monitoring (CGM) throughout the trial (3 treatment periods of 14 days) and meal tests consisting of a standardised breakfast (liquid meal) will be performed on the 14th day of each treatment period.
16162623|NCT01682889|Dietary Supplement|Arginine|L-arginine-hydrochlorid (0.35 g/kg body weight) intravenously for 24 hours
16162624|NCT01682889|Dietary Supplement|Placebo|NaCl 0.9% intravenously for 24h
16162625|NCT01682876|Biological|MenACWY-CRM|The investigational meningococcal (groups A, C, Y, and W-135 vaccine) oligosaccharide diphtheria CRM197 conjugate vaccine (MenACWY-CRM) was administered intramuscularly in the nondominant arm
16162626|NCT01682863|Drug|QVA149|QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI
16162627|NCT01682863|Drug|QVA149|QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept1 SDDPI
16162628|NCT01682863|Drug|QAB149|QAB149 and matching placebo will be supplied in capsule form in blister packs for use in the Novartis Concept1 SDDPI
16162629|NCT01682863|Drug|Placebo|To mimic QAB149
16162688|NCT01682512|Drug|Rituxan®|
16162630|NCT01682850|Behavioral|Mindfulness Based Pulmonary Rehabilitation|Participants in this group will under go 10 sessions of mindfulness based pulmonary rehabilitation prior to surgery. Each session is about 2 hours long and consists of upper /lower extremity training, breathing exercises, and education.
16162631|NCT01682850|Other|Usual Care|
16162632|NCT01682837|Drug|Potassium chloride powder|1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and again dinner, for a total of 40 meq K/day, for 4 weeks
16162633|NCT01682837|Drug|Potassium citrate powder|1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks
16162634|NCT01682837|Drug|Potassium magnesium citrate powder|1 sachet mixed with 250 ml water (providing 20 meq K) given at breakfast and dinner, for a total of 40 meq K/day, for 4 weeks
16162635|NCT01682837|Drug|Placebo|1 sachet mixed with 250 ml water given at breakfast and dinner, for a total of 2 sachets/day, for 4 weeks
16162636|NCT01682824|Other|Nutritional Assessment|Complete dietary intake assessment
16162637|NCT01682824|Other|Questionnaire Administration|Complete TFEQ-R18v2 questionnaire
16162638|NCT01682824|Other|Questionnaire Administration|Complete EQ-EMA questionnaire
16162639|NCT01682811|Drug|Part 1 Levulan injection|Control or treatment lesions will be injected with Levulan vehicle only or active drug and incubated under occlusion for 3 or 24 hrs. A minimum of three lesions per group on the same subject will be treated. Lesions will then be excised in the normal manner, sectioned vertically, and checked for Protoporphyrin IX using fluorescence microscopy.
16162640|NCT01682811|Drug|Part 1 Levulan surface application|Control or treatment lesions will be painted with Levulan vehicle only or active drug, allowed to dry, and incubated under occlusion for 3 or 24 hrs. A minimum of three lesions per group on the same subject will be treated. Lesions will then be excised in the normal manner, sectioned vertically, and checked for Protoporphyrin IX using fluorescence microscopy.
16162641|NCT01682811|Drug|Part 1 Levulan surface application twice|Control or treatment lesions will be painted twice with Levulan vehicle only or active drug, allowed to dry between and after applications, and incubated under occlusion for 3 hrs. A minimum of three tumors per group on the same subject will be treated. Lesions will then be excised in the normal manner, sectioned vertically, and checked for Protoporphyrin IX using fluorescence microscopy.
16162642|NCT01682811|Drug|Part 1 Levulan surface application twice with microneedling|Control or treatment lesions will be prepared with microneedling, painted twice with Levulan vehicle only or active drug, allowed to dry between and after applications, and incubated under occlusion for 24 hrs. A minimum of three tumors per group on the same subject will be treated. Lesions will then be excised in the normal manner, sectioned vertically, and checked for Protoporphyrin IX using fluorescence microscopy.
16162643|NCT01682811|Drug|Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 1|2-6 adult subjects with 3-8 lesions per (Levulan or control) group per subject. Controls will consist of lesions treated with vehicle only and light illumination, and will be paired with treatment lesions by the study doctor. Control lesions will be treated on the same subject as study lesions. Levulan will be incubated for 3-24 hours under occlusion, then gently rinsed with water and patted dry. Photoactivation of lesions treated with Levulan is then accomplished with 633 nm red light illumination. 633 nm light will be applied for 8 minutes to achieve a dose of 50 J/cm^2. There will be one treatment session per subject. Treatments will include a minimum of three test lesions and an additional three control lesions.
16162644|NCT01682811|Drug|Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 2|2-6 adult subjects with 3-8 lesions per (Levulan or control) group per subject. Controls will consist of lesions treated with vehicle only and light illumination, and will be paired with treatment lesions by the study doctor. Control lesions will be treated on the same subject as study lesions. Levulan will be incubated for 3-24 hours under occlusion, then gently rinsed with water and patted dry. Photoactivation of lesions treated with Levulan is then accomplished with 633 nm red light illumination. 633 nm light will be applied for 16 minutes to achieve a dose of 100 J/cm^2. There will be one treatment session per subject. Treatments will include a minimum of three test lesions and an additional three control lesions.
16162645|NCT01682811|Drug|Levulan (5-aminolevulinic acid) photodynamic therapy - Dose level 3|2-6 adult subjects with 3-8 lesions per (Levulan or control) group per subject. Controls will consist of lesions treated with vehicle only and light illumination, and will be paired with treatment lesions by the study doctor. Control lesions will be treated on the same subject as study lesions. Levulan will be incubated for 3-24 hours under occlusion, then gently rinsed with water and patted dry. Photoactivation of lesions treated with Levulan is then accomplished with 633 nm red light illumination. 633 nm light will be applied for 32 minutes to achieve a dose of 200 J/cm^2. There will be one treatment session per subject. Treatments will include a minimum of three test lesions and an additional three control lesions.
16162646|NCT01682798|Dietary Supplement|Placebo yoghurt|100g of placebo yoghurt will be taken at 10:00 am and 4:00 pm, respectively; 2 times per day.
16162647|NCT01682798|Dietary Supplement|"Yili Chang Qing Pro-ABB yoghurt (Formula 1)"|"100g of Yili Chang Qing Pro-ABB yoghurt will be taken by at 10:00 am and 4:00 pm, respectively; 2 times per day."
16162648|NCT01682798|Dietary Supplement|"Yili Chang Qing Pro-ABB yoghurt (Formula 2)"|
16162649|NCT01682772|Drug|Olaparib|Until objective disease progression, unacceptable toxicity or patient withdrawal for whatever reason
16162650|NCT01682759|Drug|Omarigliptin|
16162651|NCT01682759|Drug|Placebo to Omarigliptin|
16162652|NCT01682759|Drug|Glimepiride|Glimepiride (1 mg and/or 2 mg tablets). During the 54-week double-blind treatment period, glimepiride can be up-titrated, as appropriate, to a maximum total daily dose of 6 mg/day. Throughout the trial, down-titration of glimepiride may also occur based upon the participant's glucose measurements and clinical symptoms of hypoglycemia.
16162653|NCT01682759|Drug|Glimepiride Placebo|
16162654|NCT01682759|Drug|Metformin|Participants will continue on their stable dose (>=1500 mg/day) of open-label metformin throughout the trial.
16162655|NCT01682759|Drug|Insulin Glargine|Insulin glargine can be used for rescue therapy, if glycemic control is not maintained. Insulin therapy should be initiated as per local country insulin glargine label.
16162689|NCT01682512|Drug|MabThera®|
16162690|NCT01682499|Drug|calcium gluconate and magnesium sulfate|Intravenous calcium gluconate and magnesium sulfate, 1g each agent in 100 ml D5W over 30 minutes, immediately before and after each dose of paclitaxel
16163393|NCT01676961|Biological|romiplostim|Given SC
16162656|NCT01682746|Drug|Photofrin (porfimer sodium) & photodynamic therapy.|"Intravenous (IV) Photofrin
~This is a dose escalation study. Patients will receive Photofrin via an IV infusion approximately 24 hours prior to their tumor resection surgery and Photodynamic Therapy (PDT). Patients will be light sensitive immediately upon receiving the Photofrin and must observe photosensitivity & light precautions for a minimum of 30 days after the infusion.
~Photodynamic Therapy (PDT)
~After tumor resection, an optical fiber will be placed in the approximate center of the surgical cavity. Intralipid will be infused into the open tumor cavity while PDT is performed. The Intralipid will diffuse the light and ensure uniform delivery. Photoactivation of Photofrin is controlled by the total light dose delivered over the treatment time."
16162657|NCT01682733|Drug|Botulinum toxin|In this study, Botulinum toxin will be injected in half of the subjects not as a primary treatment modality for obesity, but to retard the muscular grinding gastric activity arount the suture insertion sites to see if it improves the durability of the gastroplasty.
16162658|NCT01682733|Device|Overstitch Endoscopic Suturing System|The gastroplasty will be accomplished by a series of intralumenally placed full thickness interrupted sutures through the gastric wall, using the FDA-approved (510K) endoscopic suturing device, the Overstitch Endoscopic Suturing System.
16162659|NCT01682720|Drug|SOF|Sofosbuvir (SOF) 400 mg tablet administered orally once daily
16162660|NCT01682720|Drug|RBV|Ribavirin (RBV) 200 mg tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16162661|NCT01682720|Drug|Placebo to match SOF|Placebo to match SOF administered orally once daily
16162662|NCT01682720|Drug|Placebo to match RBV|Placebo to match RBV administered orally in a divided daily dose
16162663|NCT01682707|Procedure|laryngoscopy|tracheal intubation with two different techniques, track light and laryngoscopy.
16162664|NCT01682707|Procedure|track light|
16162665|NCT01682694|Dietary Supplement|Glucosamine and Chondroitin|Glucosamine (1500 mg) and Chondroitin (1200 mg)
16162666|NCT01682694|Dietary Supplement|placebo|
16162667|NCT01682681|Drug|Topiramate|This is an observational study. Participants with seizures receiving topiramate as per Investigator's discretion will be observed.
16162668|NCT01682668|Procedure|Bilateral subthalamic stimulation|
16162669|NCT01682642|Drug|Zoladex|after surgical vaporization patients are treated with Zoladex for 3 months before starting IVF treatment
16162670|NCT01682629|Other|Debriefing Script|"A debriefing script was designed for novice instructors to facilitate a 20-minute debriefing session. It was developed in iterative steps: (a) review of PALS learning objectives; (b) categorization of script content; (c) development of scripted language; (d) formatting into a cognitive aid and (e) pilot testing script for usability with subsequent edits before implementation in the study.
~All novice instructors received the scenario 2 weeks prior to the study session. Instructors randomized to scripted debriefing were also given the script with no instruction on how to use it except on the day of the study, to use and follow the script as closely as possible during the debriefing session. All instructors held a clipboard while observing the simulation session; to hold the debriefing script and/or take notes. This allowed for blinding of the video reviewers as to which study arm the team had been randomized. Debriefing sessions were limited to 20-minutes in duration."
16162671|NCT01682629|Other|High Physical Realism Simulation|"High vs. Low Physical Realism Simulators A pre-programmed infant simulator was used for all simulation sessions. To create high physical realism (HiR), full simulator functions were activated (turned on) including vital sign monitoring, audio feedback, breath sounds, chest rise, heart sounds, palpable pulses, and vocalization. Low physical realism (LoR) groups had the identical simulator but the compressor was turned off, thus eliminating physical findings described above. In addition, the LoR simulator was connected to a monitor, but it only displayed the cardiac rhythm, and not pulse oximetry, respiratory rate, blood pressure, temperature and audio feedback present in the HiR group. All other aspects of the simulated resuscitation environment were standardized for all groups."
16162672|NCT01682616|Drug|ABT-199|ABT-199 is taken continuously once daily. This is a dose escalation study, therefore the dose of ABT-199 will change throughout the study.
16162673|NCT01682616|Drug|Rituximab|Rituximab will be given by intravenous infusion on day 1 of Months 1, 2, 3, 4, 5, and 6. May be reinitiated for an additional 6 months.
16162674|NCT01682603|Drug|Botulinum toxin A|BoNT-A (BOTOX 300U)
16162675|NCT01682590|Procedure|Renal Remplacement Therapy|"Investigators of each center will have the choice of the RRT technique based on their usual practice: intermittent hemodialysis, intermittent hemodiafiltration, continuous hemodialysis, continuous hemofiltration, continuous hemodiafiltration (typically the continuous techniques in the acute phase, followed by intermittent techniques after stabilization).
~In case of life threatening conditions within the 48 hours after randomisation (hyperkalemia, metabolic acidosis or pulmonary edema) the RRT will be initiated as soon as possible.
~In case of improvement of renal function within the 48 hours after randomisation (defined as the return of spontaneous urine output > 1000ml/24 hr or >2000ml/24hr with diuretics), RRT is not mandatory."
16162676|NCT01682577|Drug|Perindopril 4 mg tablets of PT Dexa Medica|Test product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.
16162677|NCT01682577|Drug|Perindopril 4 mg tablets of Servier|Reference product was given as a single dose, under the procedure as described in the Section: Detailed description of the study.
16162678|NCT01682564|Drug|Candemore tablet|"Initial dose : 4mg/day if SBP<140mmHg and/or DBP<90mmHg, 8mg/day if SBP≥140mmHg and DBP≥90mmHg
~dose escalation : double dose if SBP≥100mmHg and DBP>60mmHg (maximum dose 16mg/day)"
16162679|NCT01682564|Drug|Atacand tablet|"Initial dose : 4mg/day if SBP<140mmHg and/or DBP<90mmHg, 8mg/day if SBP≥140mmHg and DBP≥90mmHg
~dose escalation : double dose if SBP≥100mmHg and DBP>60mmHg (maximum dose 16mg/day)"
16162680|NCT01682551|Drug|Chinese Medicine|"The participators in this arm will take 2g (powder in capsule) of Wu Zhu Yu Tang or placebo orally three times in the first day and one time in the second day."
16162681|NCT01682551|Drug|Acetalozamide|"If the participators have the history of AMS, he/she will be randomized to take Wu Zhu Yu Tang plus placebo of Acetalozamide or Acetalozamide plus placebo of Wu Zhu Yu Tang."
16162682|NCT01682538|Drug|Nitisinone, capsule|
16162683|NCT01682538|Drug|Nitisinone, suspension|
16162684|NCT01682525|Other|Frozen ovarian tissue|Use of ovarian tissue cryopreserved and stored at Boston IVF
16162685|NCT01682512|Drug|BI 695500|
16162691|NCT01682486|Device|BIP ETT (Bactiguard)|Ventilation of surgery patients during anesthesia using BIP ETT
16162692|NCT01682486|Procedure|Standard ETT|Ventilation of surgery patients during anesthesia using standard ETT
16162693|NCT01682473|Drug|ZSTK474|Two arms, each with serial cohorts receiving escalating doses.
16162694|NCT01682460|Drug|Refresh Tears Lubricant Eye Drops (Allergan)|Eye drops QID for 1 month
16162695|NCT01682447|Other|Extensive Pulmonary Rehabilitation Program|Fulltime pulmonary rehabilitation program. Duration: 12 weeks
16162696|NCT01682434|Procedure|Laser in situ keratomileusis (LASIK)|Wavefront guided treatment in one eye, conventional in the other.
16162697|NCT01682421|Drug|Weak steroid (Flurolon, Allergan)|
16162698|NCT01682421|Drug|Potent steroid (Maxidex, Alcon)|
16162699|NCT01682408|Drug|Fostamatinib - 1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference)|1 x 150mg mannitol-based 38% drug-loaded tablet(orange reference)
16162700|NCT01682408|Drug|Fostamatinib - 3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed|3 x 50mg microcrystalline cellulose-based 13% drug loaded tablets,(blue) fed
16162701|NCT01682408|Drug|Fostamatinib - 1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A)|1 x 150mg mannitol based 38% drug-loaded tablet (batch variant A)
16162702|NCT01682408|Drug|Fostamatinib - 1 x 150mg mannitol based 38% drug loaded tablet (batch variant B)|1 x 150mg mannitol based 38% drug loaded tablet(batch variant B)
16162703|NCT01682408|Drug|Ranitidine|150 mg ranitidine
16162704|NCT01682395|Procedure|Resection and anastomosis|Resection of sigmoid colon with primary anastomosis
16162705|NCT01682395|Procedure|Resection and colostomy|Resection of sigmoid colon with end colostomy and Hartmann's pouch, followed at a later date by Hartmann's reversal as a second surgical procedure
16162706|NCT01682395|Procedure|Mesosigmoidopexy|Mesosigmoidopexy--the fixation of the sigmoid colon to lateral abdominal wall with concomitant shortening of the mesosigmoid length.
16162707|NCT01682369|Biological|TIV (Aggripal)|
16162708|NCT01682369|Biological|ATIV (Fluad)|
16162709|NCT01682356|Dietary Supplement|Beetroot Juice (BRJ)|double-blind placebo-controlled cross-over study
16162710|NCT01682356|Dietary Supplement|placebo|double-blind placebo-controlled cross-over study
16162711|NCT01682343|Dietary Supplement|Calcium|Milk-calcium supplement
16162712|NCT01682317|Behavioral|Eating Frequency|Thirty adults will be provided an 8-week standard lifestyle intervention, that includes a 1200-1500 kcal/day, < 30% energy from fat dietary prescription, and a physical activity goal of 200 minutes/week. Participants will be randomized to one of two conditions differing in EF using a prescription we have tested previously. One condition will limit the number of eating bouts/day to three (Three Meal), while the second condition will consume at least 100 kcal every 2 to 3 hours which should lead to approximately 6 eating bouts/day (Grazing).
16162713|NCT01682291|Behavioral|Life-style modifications|Weight loss of as little as 10 lbs (4.5 kg) Adoption of the Dietary Approaches to Stop Hypertension (DASH) eating plan Dietary sodium should be reduced to no more than 2.4 g of sodium per day Regular aerobic physical activity (at least 30 minutes per day)
16162714|NCT01682291|Dietary Supplement|Dietary supplements|combined pill (1 capsule/day containing Allium sativum (Dosage: 1,000 mg/day), Crataegus monogyna (Dosage: 500 mg/day), Orthosiphon (Dosage: 300 mg/day), Hibiscus sabdariffa (Dosage: 250 mg/day)
16162715|NCT01682278|Device|Removal of dental amalgam restorations|"Patients in the amalgam cohort will have all dental amalgam restorations removed and replaced with other restorative materials used in modern dentistry. Amalgam removal will be performed by the patient's regular dentist or another dentist chosen by the patient."
16162716|NCT01682265|Other|Stretta procedure|
16162717|NCT01682265|Other|Sham procedure|No radiofrequency delivered
16162718|NCT01682239|Other|RVAP|In this arm pacemaker leads will be placed in the RV apex.
16162719|NCT01682239|Other|RVSP|In this arm pacemaker leads will be placed in the RV septum.
16162720|NCT01682226|Device|CliniMACS Fractionation system (Arm A)|"7 days before transplant Admit to hospital. Line insertion 6 days before transplant Fludarabine (chemotherapy) Cyclophosphamide (chemotherapy) 5 days before transplant Fludarabine Thiotepa 4 days before transplant Fludarabine Thiotepa 3 days before transplant Fludarabine Start CSA and MMF 2 days before transplant Fludarabine and TBI (radiation therapy)
~1 day before transplant TBI (radiation therapy) Day of transplant Transplant day (infuse cord blood) Day after cord blood transplant Infuse family member stem cells 7 days after transplant Start G-CSF"
16162721|NCT01682226|Device|CliniMACS Fractionation system (Arm B)|"8 days before transplant Admit to hospital. Line insertion 7 days before transplant Fludarabine 6 days before transplant Fludarabine Cyclophosphamide 5 days before transplant Fludarabine Cyclophosphamide 4 days before transplant Rest 3 days before transplant TBI x 3 Start CSA and MMF 2 days before transplant TBI x 3
~1 day before transplant TBI x 3 Day of transplant TBI x 2 then infuse cord blood
~1 day after the cord blood transplant Infuse family member stem cells 7 days after transplant Start G-CSF"
16162722|NCT01682213|Drug|Dabrafenib|Following definitive surgical resection, eligible patients will receive dabrafenib at 150 mg twice a day by mouth for 4 cycles (± 5 days). One cycle is 28 days.
16162723|NCT01682200|Drug|ProOxy|Clean the face with ProOxy facial wash before spraying ProOxy on the face enough to wet it twice daily, upon waking up and before bedtime.
16162724|NCT01682187|Drug|LY2157299|Administered orally
16162725|NCT01682187|Drug|Lomustine|Administered orally
16162726|NCT01682174|Other|Control Drink|
16162727|NCT01682174|Other|Experimental Drink|
16162728|NCT01682161|Drug|Paliperidone palmitate|Paliperidone palmitate will be administrated in accordance with each product's information. Recommended initial loading doses are 150 mg equivalent on Day 1 and 100 mg equivalent on Day 8, followed by subsequent once-monthly administration with 75 mg equivalent or flexible dose between 25 mg and 150 mg equivalent.
16162729|NCT01682148|Biological|Botulinum toxin type A|
16162730|NCT01682135|Biological|Ramucirumab|Administered IV.
16162731|NCT01682109|Drug|Valacyclovir|
16162732|NCT01682096|Radiation|computed coronary angiography|Patients will be pre-medicated with atenolol 50 mg 1h prior to the scan.
16162733|NCT01682096|Procedure|Exercise stress echocardiography|Limited by symptoms
16162734|NCT01682083|Drug|Dabrafenib|Each capsule contained 50 mg or 75 mg of free base (present as the mesylate salt)
16163394|NCT01676948|Drug|ACZ885|
16162735|NCT01682083|Drug|Trametinib|Each tablet contained 0.5 mg or 2.0 mg of trametinib parent (present as the DMSO solvate)
16162736|NCT01682083|Drug|Placebos|The placebo capsules and tablets contained the same inactive ingredients and film coatings as the dabrafenib and trametinib study treatment
16162737|NCT01682070|Biological|SUBLIVAC FIX phleum prat.|Comparison of different dosages to placebo
16162738|NCT01682070|Biological|Placebo|
16162739|NCT01682057|Device|ROX ANASTOMOTIC COUPLER SYSTEM (ACS)|The ROX Anastomic Coupler (ACS) will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein).
16162740|NCT01682057|Device|ROX Anastomotic Coupler System (ACS)|
16162741|NCT01682044|Biological|pegfilgrastim|Given SC
16162742|NCT01682044|Biological|rituximab|Given IV
16162743|NCT01682044|Other|flow cytometry|Correlative studies
16162744|NCT01682044|Procedure|biopsy|Correlative studies
16162745|NCT01682044|Other|immunohistochemistry staining method|Correlative studies
16162746|NCT01682044|Genetic|western blotting|Correlative studies
16162747|NCT01682031|Dietary Supplement|selenomethionine|Given PO
16162748|NCT01682031|Other|placebo|Given PO
16162749|NCT01682031|Drug|cisplatin|Given IV
16162750|NCT01682031|Radiation|radiation therapy|Undergo radiotherapy
16162751|NCT01682031|Procedure|quality-of-life assessment|Ancillary studies
16162752|NCT01682018|Device|lung volume reduction using the Zephyr device|lung volume reduction using the Zephyr device
16162753|NCT01682005|Other|Data interpretation|The data collected for each group will be fully de-identified, interpreted and analysed separately for the 2 databases (MarketScan Commercial and MarketScan Medicaid).
16162754|NCT01681992|Biological|Priorix|Subjects receive one dose of either minimum (Inv_MMR_Min) or medium (Inv_MMR_Med) potency lot at Day 0 and a dose of separate potency lot (Inv_MMR_Release) at Day 42, administered subcutaneously in the triceps region of the left arm.
16162755|NCT01681992|Biological|M-M-R II|Subjects receive two doses of either Lot 1 or Lot 2, one at Day 0 and one at Day 42, administered subcutaneously in the triceps region of the left arm.
16162756|NCT01681992|Biological|Varivax|Subjects receive one dose co-administered subcutaneously with the study vaccines (Priorix and M-M-R II), in the triceps region of right arm, at Day 0.
16162757|NCT01681992|Biological|Havrix|Subjects receive one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the right thigh, at Day 0.
16162758|NCT01681992|Biological|Prevnar 13|US Subjects receive one dose co-administered intramuscularly with the study vaccines (Priorix and M-M-R II), in the anterolateral region of the left thigh, at Day 0.
16162759|NCT01681979|Drug|Fluticasone propionate (with and without concurrent salmeterol)|"Fluticasone propionate is an inhaled corticosteroid used for the treatment of asthma, often in combination with the long-acting β-agonist salmeterol. For the primary endpoint, exposure status will be determined based on the individual receiving a prescription for the drug of interest (fluticasone propionate or another inhaled corticosteroid) in the 2 weeks immediately before the LMP date or during the first trimester of pregnancy.
~Sensitivity analysis will be carried out categorising exposure based on mapping the duration of prescriptions based on the number of inhalers, number of puffs within an inhaler and the prescribed daily dose."
16162760|NCT01681966|Drug|PRF110- oily solution (Ropivacaine)|Post operative application of PRF110-oily solution (Ropivacaine)
16162761|NCT01681953|Drug|Lamazym|ERT, i.v. infusions weekly
16162762|NCT01681953|Drug|Placebo|Infusions weekly
16162763|NCT01681940|Drug|Lamazym|ERT, i.v. infusions weekly
16162764|NCT01681901|Procedure|ultrasound imaging|Undergo ultrasound
16162765|NCT01681888|Device|Sanger EMG Biofeedback Device|
16162766|NCT01681875|Other|very low nicotine content cigarettes|
16162767|NCT01681862|Behavioral|Personal Health Record|"Participants data collected during the scheduled blood pressure sessions will be uploaded to the church PHR system. Lay health workers (LHWs) will then have the capability to access the blood pressure readings and health behavior data through the Congregational Dashboard where they can display the information in easy-to-read charts and graphs that highlight the blood pressure trends across the measurements and changes in fruit and vegetable intake, level of physical activity and weight. The registry will also incorporate computerized health education modules through and evidence-based guidelines for blood pressure control and the NHLBI publications Your Guide to Lowering Blood Pressure and Facts about the DASH Eating Plan."
16162768|NCT01681849|Drug|Placebo|Following a three month double blind phase, subjects will be treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.
16162769|NCT01681849|Drug|Paroxetine|Following a three month double blind phase, subjects will be treated with open label paroxetine at a variable dosage of 10-40 mg to reach individual therapeutic levels for three months.
16162770|NCT01681849|Other|Positron Emission Tomography (PET) Imaging|Participants will undergo positron emission tomography (PET) imaging of the brain with O-15 radiolabelled water with exposure to traumatic scripts
16162771|NCT01681836|Drug|15Nitrogen(15N)-labeled sodium nitrite|15Nitrogen(15N)-labeled sodium nitrite 20 mg once
16162772|NCT01681836|Drug|15Nitrogen(15N)-labeled sodium nitrate|15Nitrogen(15N)-labeled sodium nitrate 1,000 mg once
16162773|NCT01681823|Dietary Supplement|PectaSol-C Modified Citrus Pectin (MCP)|Oral administration of PectaSol-C MCP (4.8 grams in six capsules three times a day away from food).
16162774|NCT01681810|Drug|14Nitrogen Sodium Nitrite|oral formulation of sodium nitrite 40 mg three times a day for 12 weeks
16162775|NCT01681797|Device|Fluorescence angiography (Fluobeam™ imaging system developed by Fluoptics company)|Fluorescence angiography after intravenous injection of Infracyanine® (indocyanine green)
16162776|NCT01681771|Behavioral|Cognitive behaviour therapy|Internet based, weekly home task and weekly feedback provided by health care professional.
16162777|NCT01681771|Behavioral|Discussion group|Internet moderated discussion group. Patients will be provided weekly question which will be used by the participant to start discuss with each others.
16162778|NCT01681758|Other|IV fluid according to PPV|intravenous fluids
16162779|NCT01681758|Other|fluids according to standard care|
16162780|NCT01681745|Device|Cryo-Touch III|
16162781|NCT01681732|Other|Personalized Care Plan|We will develop a personalized plan based on info collected in the primary visit
16162782|NCT01681732|Other|Control Standard Care|This is the standard care arm
16162783|NCT01681719|Device|WBV and Resistance|"use of WBV and resistance device during 03 months in elderly health people. The WBV used progressive increases of time and amplitude and the resistance training improves the weight.
~For Resistance: performed in upper and lower limbs in weight machine Mega II Movement®, used guidelines from American College of Sports Medicine for elderly, with two series of 08 repetitions (75% weight of one RM), considered for RM calculation the maximum voluntary isometric contraction.
~For WBV: used MY3 platform (Power Plate®, MY3, UK) frequency 35 hertz, tri-axial, amplitude 02 mm in adaptation and initial phases, increasing to 04 mm in phases intermediate and final. The time initial was 10 minutes, progressed to 15 min in second month, concluding with 20 min. Rest time between series remained 01 min."
16162784|NCT01681719|Device|resistance & sham WBV|"used only resistance
~For Resistance: performed in upper and lower limbs in weight machine Mega II Movement®, used guidelines from American College of Sports Medicine for elderly, with two series of 08 repetitions (75% weight of one RM), considered for RM calculation the maximum voluntary isometric contraction.
~For WBV: used MY3 platform (Power Plate®, MY3, UK)off."
16162785|NCT01681719|Device|WBV & resistance sham|"used really the WBV, but sham for resistance training
~For Resistance: performed similar movments in upper and lower limbs in weight machine Mega II Movement®, without using weights.
~For WBV: used MY3 platform (Power Plate®, MY3, UK) frequency 35 hertz, tri-axial, amplitude 02 mm in adaptation and initial phases, increasing to 04 mm in phases intermediate and final. The time initial was 10 minutes, progressed to 15 min in second month, concluding with 20 min. Rest time between series remained 01 min."
16162786|NCT01681693|Drug|Metformin|Subjects will be given an oral dose of metformin once per day for two days.
16162787|NCT01681680|Drug|Metformin|Subjects will be given an oral dose of metformin once per day for two days.
16162788|NCT01681667|Drug|Ibuprofen|ibuprofen liquid 400mg vs. ibuprofen tablet 400mg
16162789|NCT01681654|Behavioral|Lifestyle Intervention|Participants in the Lifestyle Intervention will receive a 12-week individualized exercise and dietary program based on their exercise assessment and dual energy x-ray absorptiometry (DXA) scan results, will attend twice weekly group exercise classes, and perform their individualized at-home program an additional two times per week. In addition, participants will be required to attend six education sessions during the 12-week intervention.
16162790|NCT01681654|Behavioral|Maintenance Intervention|Patients randomized to receive the Maintenance Program Intervention following treatment will receive a Survivorship Care Plan outlining their physical activity, dietary, and health behaviour progress throughout the program, future goals, individualized maintenance strategies, and optional drop-in exercise sessions.
16162791|NCT01681641|Other|A psycho-social intervention|
16162792|NCT01681628|Behavioral|Thought Field Therapy.|Thought Field Therapy is a meridian based therapy, where clients tap on specific parts of their body, according to a particular protocol. This does not obliterate the memory of the trauma, but relieves the associated distress.
16162793|NCT01681615|Drug|Acetylsalicylate|1-2 drops
16162794|NCT01681615|Drug|Isotonic NaCl|1 drop
16162795|NCT01681602|Other|Aerobic exercise|Physical exercise in the intervention group will be delivered as an individually tailored program consisting of 4 weeks of adaptation exercise followed by 12 weeks of continuously supervised moderate aerobic exercise 1 hour three times a week. The participants can choose from treadmill, stationary bike and crosstrainer.
16162796|NCT01681589|Device|Transcranial Direct Current Stimulator (TDCS)|Group will receive active TDCS
16162797|NCT01681589|Device|Control Group|This group will receive Sham TDCS
16162798|NCT01681589|Other|Healthy Control Group|Healthy Controls will be involved in the Study. Healthy Controls will receive no Intervention. There will be 1 screening visit and 1 testing visits.
16162799|NCT01681576|Drug|Valsartan|Valsartan 320mg tablet once daily
16162800|NCT01681576|Drug|LCZ696|LCZ696 400mg tablet once daily
16162801|NCT01681563|Drug|Pentostatin|Lyophilized powder for intravenous administration.
16162802|NCT01681563|Drug|Cyclophosphamide|IV
16162803|NCT01681563|Drug|Ofatumumab|Liquid concentrate for solution for infusion.
16162804|NCT01681550|Drug|Incretin-based therapy|
16162805|NCT01681537|Drug|Lenalidomide|
16162806|NCT01681537|Drug|Mitoxantrone|
16162807|NCT01681537|Drug|Etoposide|
16162808|NCT01681537|Drug|Cytarabine|
16162809|NCT01681524|Drug|Flurpiridaz F18|Injection of Flurpiridaz F18 for the purposes of PET MPI analysis
16162810|NCT01681511|Device|ICET™ TIC Foley Catheter|The device to be evaluated in this investigation is a silver-based antimicrobial coated Foley catheter connected to an antimicrobial anti-reflux accessory (ICET Inc, Norwood, MA). The closed system is referred to as the TIC system and is designed with the objective of reducing the incidence of CAUTI. The accessory is non-tissue contacting.
16162811|NCT01681511|Device|BARD® LUBRI-SIL® IC Foley Catheter|The LUBRI-SIL® I.C. antimicrobial 100% silicone Foley catheter incorporates a formulation consisting of BACTI-GUARD®* silver alloy coating and BARD® hydrogel.
16162812|NCT01681472|Drug|6R-MTHF (arfolitixorin) 200 mg/m2|i.v. bolus injection
16162813|NCT01681472|Drug|Levoleucovorin 200 mg/m2|i.v. bolus injection
16162814|NCT01681472|Drug|6R-MTHF (arfolitixorin) 60 mg/m2|i.v. bolus injection
16162815|NCT01681472|Drug|Levoleucovorin 60 mg/m2|i.v. bolus injection
16162816|NCT01681446|Drug|interferon-alpha (IFN-alpha)|interferon-alpha is intramuscular injected 30 μg three times a week or 50 μg twice a week for 18 months
16162817|NCT01681433|Drug|OGX-427|OGX-427 started within 7 days of randomization, three loading doses of 600 mg IV within Week 1 if possible (up to 10 days of initiating treatment), followed by weekly doses of 800 mg IV
16162818|NCT01681433|Drug|Abiraterone Acetate|Standard therapy: Abiraterone Acetate 1000 mg PO daily
16162819|NCT01681433|Drug|Prednisone|Standard therapy: Prednisone 10-20 mg PO daily
16162820|NCT01681420|Behavioral|HIV Counseling and Testing|HIV counseling and testing in lieu of blood donation.
16162821|NCT01681420|Behavioral|Blood Donation|Blood donation without HIV counseling
16162822|NCT01681394|Dietary Supplement|Polyphenol-rich cocoa extract|250 g of chocolate cream supplemented with 2.3 g of polyphenol-rich cocoa extract (containing 1050 mg of total polyphenols)
16162823|NCT01681394|Dietary Supplement|Chocolate cream|
16163395|NCT01676948|Drug|Canakinumab|
16162824|NCT01681381|Device|Tivoli® DES|Device:Tivoli® DES The Tivoli® DES drug eluting stent(Tivoli® DES) is an open cell balloon expandable cobalt chromium stent coated with a bio-gradable polymer (PLGA) containing rapamycin at a dose of 8 micrograms per millimeter of stent length. In vitro assays have shown that about 50% of the drug releasing in 1 week and approximately 80% releasing in 28 days. The polymer may be degraded in 3 to 6 months in human body. This stent is supplied pre-mounted on a delivery catheter and is available in the following sizes: lengths of 10、15、18、21、25、30、35 mm and diameters of 2.5、2.75、3.0、3.5、4.0 mm.
16162825|NCT01681381|Device|Firebird2® DES|The Firebird2® rapamycin-eluting stent (Firebird2® DES) is an open cell balloon expandable cobalt chromium stent coated with a biocompatible durable styrene-butylenes-styrene (SBS) polymer containing rapamycin at a dose of 9 micrograms per millimeter of stent length. In vitro assays have shown that about 50% of the drug elutes in 1 week and approximately 90% elutes in 1 month. This stent is supplied pre-mounted on a delivery catheter and is available in the following sizes: lengths of 13, 18, 23, 29, 33 mm and diameters of 2.25, 2.5, 2.75, 3.0, 3.5, 4.0 mm.
16162826|NCT01681368|Drug|Birinapant (TL32711)|47mg/m^2 intravenous (IV) on days 1, 8 and 15 of each 28 day cycle
16162827|NCT01681355|Other|Infant Formula|Standard cow's milk based infant formula with added prebiotic oligosaccharides, and a modified fat blend and protein composition
16162828|NCT01681329|Behavioral|Cognitive-behavioral therapy|Cognitive-behavioral therapy addressing intolerance of uncertainty, positive beliefs about worry, negative problem orientation, and cognitive avoidance
16162829|NCT01681329|Other|Interpretation training|Computerized interpretation training using Word-Sentence Association Paradigm
16162830|NCT01681316|Drug|Danhong injection|A kind of injection made from two kind of Chinese herbs: salvia miltiorrhiza and safflower
16162831|NCT01681316|Other|Standard medical care|Standard medical care is in accordance with China Guideline for the diagnosis and treatment of Chronic Stable Angina (2007).
16162832|NCT01681316|Drug|Placebo|0.9% saline added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion.
16162833|NCT01681303|Drug|AST-120|
16162834|NCT01681290|Drug|CBX129801|
16162835|NCT01681277|Drug|BI 113608 PIB bid|powder for oral solution
16162836|NCT01681277|Drug|Placebo to BI 113608 PIB bid|powder for oral solution
16162837|NCT01681277|Drug|Placebo to BI 113608 PIB bid|powder for oral solution
16162838|NCT01681277|Drug|Placebo to BI 113608 PIB qd|powder for oral solution
16162839|NCT01681277|Drug|Placebo to BI 113608 PIB bid|powder for oral solution
16162840|NCT01681277|Drug|BI 113608 PIB bid|powder for oral solution
16162841|NCT01681277|Drug|BI 113608 PIB bid|powder for oral solution
16162842|NCT01681277|Drug|BI 113608 PIB qd|powder for oral solution
16162843|NCT01681264|Drug|Morphine|
16162844|NCT01681264|Drug|Guanfacine 1mg|
16162845|NCT01681264|Drug|Guanfacine 2mg|
16162846|NCT01681264|Drug|Placebo|
16162847|NCT01681251|Other|Fluid titrated with the use of arterial pulse contour cardiac output monitor if SVV >13%|"Following induction of anesthesia, Voluven boluses of 250ml will be given if SVV increases above 10%. Further Voluven boluses will be given in 250ml aliquots should the SVV increase to greater than 10%. If a total of 55ml/kg of Voluven is given, the fluid will be changed to lactated ringers and no further colloid will be given, as this is the maximum dose recommend by the manufacturer.
~Vasoactive agents (type and dose at the discretion of the attending anesthesiologist) may be given to maintain a mean arterial pressure that the clinical team feels adequate to maintain adequate organ perfusion. In the intervention group, however, vasoactive agents will not be given unless fluid administration has resulted in a maximal value of SV."
16162848|NCT01681251|Other|Fluid titrated at the discretion of the attending anesthesiologist|In the control group, the data from the FloTrac monitor will not be available to the anesthesia care provider. Fluid replacement will be at a rate and of a type that is entirely up to the anesthesiologist; the only stipulation being that Voluven is to be used should the provider desire to use a colloid solution.
16162849|NCT01681238|Procedure|Protocol group 2|ensure SpO2≥ 92%, MAP 65-100 mmHg, HR <100 bpm, Hb> 8mg/dL and temperature ≥ 36℃, the patients were then administrated a 200 ml colloid as a fluid challenge. The fluid challenge repeat until the SV failed to increase by a factor of 10%. If at this stage the DO2I can not be greater than 600 mL/m2, then dobutamine will be started at a dose of 2.5 μg/kg/min and increased by the same increment every 20 minutes until the described target is reached or until a maximal dose of 20 μg/kg/min is given. Dobutamine is decreased in dose or discontinued if the heart rate is above 120 beats per minute or shows signs of cardiac ischemia. Blood transfusions will be used to maintain a hemoglobin concentration over 8mg/dL
16162850|NCT01681238|Procedure|Protocol group 1|The goal of this protocol is to ensure MAP> 65 mmHg, CVP 8-12 cmH2O. If meet the above requirements, do nothing, re-evaluate after 5min. If CVP <8 cmH2O, the patient will receive an additional 200ml colloid .If MAP beyond the scope of 65-100 mmHg, vasoactive agents will be administrated until achieve the goal. If 25mL/kg colloid given before goal is achieved, fluid challenges will then be performed with 200mL boluses of Ringer's lactate solution. Blood transfusions will be used to maintain a hemoglobin concentration over 8mg/dL
16162851|NCT01681225|Other|Esophageal-pressure guided mechanical ventilation|
16162852|NCT01681225|Other|High PEEP mechanical ventilation|
16162853|NCT01681212|Drug|Ipilimumab|
16162854|NCT01681212|Drug|Dacarbazine|
16162855|NCT01681199|Drug|Fluvastatin extended release tablet|
16162856|NCT01681186|Drug|LY2940680 Capsule(s) (Reference)|Administered orally as a capsule(s)
16162857|NCT01681186|Drug|LY2940680 Tablet (Test)|Administered orally as a tablet
16162858|NCT01681186|Drug|Lansoprazole|Administered orally as a capsule
16162859|NCT01681186|Drug|Placebo Capsule(s)|Administered orally as a capsule(s)
16162860|NCT01681173|Dietary Supplement|Fiber|200ml drinks enriched with 7,5g of fiber (90% insoluble fiber, 10% soluble fiber), BID, over 24 months
16162861|NCT01681173|Dietary Supplement|Placebo|200ml Placebo, BID, over 24 months
16162862|NCT01681160|Other|procedure:maggot therapy|each times in maggot therapy continued for three days.wound assessment was done before and after any intervention
16162863|NCT01681160|Other|conventional therapy|patients receive ordinary treatment for diabetic foot
16241675|NCT01072214|Drug|pazopanib|gw786034
16162864|NCT01681147|Behavioral|2 online nutrition and exercise education classes|Two online nutrition and physical activity classes will accessed from a computer, android phone or a tablet. Each class is estimated to last about 1.5- 2 hours and will be accessed 6 weeks-3 months and 9 months
16162865|NCT01681147|Behavioral|Self monitoring of blood glucose levels|Self monitoring of blood glucose levels four times a day for four consecutive days once a month from 6 weeks-3 months through 9 months post partum
16162866|NCT01681134|Drug|Advagraf®|oral
16162867|NCT01681134|Drug|Prograf®|oral
16162868|NCT01681121|Drug|ADX-N05|150 mg once a day for 4 weeks followed by 300 mg once a day for 8 weeks
16162869|NCT01681121|Drug|Placebo|One capsule placebo to match ADX-N05 to be taken for 4 weeks followed by 2 capsules placebo to match ADX-N05 to be taken for 8 weeks
16162870|NCT01681108|Behavioral|Lifestyle counseling|Individualized meal planning and exercise regimen sessions will be developed for each participant
16162871|NCT01681095|Drug|Custodiol HTK|After cross-clamping of the aorta approximately 1-2 L of Custodiol-HTK was infused into the ascending aorta over 6-8 minutes. Additional doses of 100-200 ml were administered as needed. The cardioplegic solution was delivered at a temperature of 4°C - 10°C.
16162872|NCT01681095|Drug|Cold Blood Cardioplegia|After cross-clamping the aorta, at least 1000 mL of a 4:1 mixture of cold blood: cold crystalloid was administered at a pressure of 300 mmHg or less via a twin roller pump. Every 20 minutes an additional > 200 mL was administered in an antegrade/retrograde fashion throughout the remainder of the case. The cardioplegic solution was delivered at a temperature of 4°C - 8°C.
16162873|NCT01681082|Behavioral|Tai Chi training|24 form Yang style Tai Chi. 50 minute sessions, twice weekly.
16162874|NCT01681069|Dietary Supplement|IQP-VV-102|
16162875|NCT01681069|Other|Placebo|
16162876|NCT01681056|Behavioral|Autosuggestion for 30 days|
16162877|NCT01681043|Behavioral|protocol 'Quiet in the room'|"Protocol 'Quite in the room' between 10 p.m. and 6 a.m.
~nurse nearby
~no visits after 10 p.m.
~decreased alarm sound in ventilator and monitor
~decreased light intensity
~no unnecessary conversations around the patient
~medication should be limited to max 1-2 times in this time period
~no unnecessary therapeutic or diagnostic procedures in this time period
~earplugs and sleep masks"
16162878|NCT01681030|Biological|EVARREST™|EVARREST™ Fibrin Sealant Patch is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
16162879|NCT01681030|Biological|Topical hemostat|Equine collagen with Human Fibrinogen and Human Thrombin
16162880|NCT01681030|Other|Standard of Care|SoC is a composite of techniques/methods typically used by the surgeon to control bleeding after conventional methods (i.e. suture, ligation, cautery) are ineffective or impractical.
16162881|NCT01681017|Behavioral|HBB/ENC Training and Equipment|See the detailed description section
16162882|NCT01681017|Other|HBB/ENC supplies|Staffs associated with participating facilities receive HBB/ENC training and use related equipment.
16162883|NCT01681004|Device|iFuse Implant System|Placement of iFuse implant system via surgery
16162884|NCT01681004|Other|Non-surgical management|Medications for pain, physical therapy, SI joint injection and RF ablation
16162885|NCT01680991|Drug|Obinutuzumab|Multiple doses of obinutuzumab.
16162886|NCT01680978|Drug|aleglitazar|150 mcg orally daily, 6 weeks
16162887|NCT01680978|Drug|placebo|orally daily, 6 weeks
16162888|NCT01680965|Drug|Ofatumumab|"Phase I: test an escalating dose of ofatumumab at cohorts of 300 mg, 700 mg, and 1000 mg given on day 0 and 14 of study.
~Phase II: Ofatumumab MTD on day 0 and 14; patients will be followed for total of 24 months (months 1, 3, 6, 12 after therapy, then at 18 and 24 months following therapy)"
16162889|NCT01680952|Drug|A) TEST|"Extended Release Tacrolimus (Advagraf®)
~① Living The day before surgery: 0.2 mg/kg(morning dose) po, qd Morning on the day of surgery: 0.1 mg/kg po, qd After surgery, the capacity is adjusted according to the trough level. clinical significance, electrolyte level.
~② Cadaveric Before surgery at once : 0.1 mg/kg within 12hours before surgery. After surgery : 0.2mg/kg po. in the morning After that, the capacity is adjusted according to the trough level. clinical significance, electrolyte level.
~Sirolimus (Rapamune®):
~After surgery : 2mg/kg po. within 24hrs after reperfusion. After that, the capacity is adjusted according to the trough level."
16162890|NCT01680952|Drug|B) CONTROL|"Extended Release Tacrolimus (Advagraf®)
~: Same as above.
~Mycophenolate mofetil : After surgery : 500mg/kg po. within 24hrs after reperfusion. After that, daily dose: 1000mg bid"
16162891|NCT01680939|Drug|Morphine|0.2-0.5 mg/kg PO q4h
16162892|NCT01680939|Drug|Ibuprofen|10mg/kg PO q6hrs
16162893|NCT01680926|Dietary Supplement|Almased|During the first week, all three main meals were replaced with 50 g of a protein-rich meal replacement (Almased) (=1100 kcal per day). During weeks 2-4, only two meals were replaced and a protein-rich lunch was allowed. During weeks 5-12, only dinner was replaced.
16162894|NCT01680913|Procedure|Ultrasound guidance|The intervention group's interspaces will be determined using the curved linear probe on a Zonare ultrasound using two views.
16162895|NCT01680913|Procedure|Palpation of Tuffier's line|Current clinical practice. Standard of care would have the attending anesthetist palpate the Tuffier's line to pinpoint the appropriate location for the spinal.
16162896|NCT01680913|Procedure|Spinal anesthetic|Subcutaneous local infiltration with a 25g needle we be performed prior to the spinal. Neuraxial technique will be attempted midline with a 25 gauge whitacre needle in the sitting position. Spinals will be attempted on either L2-L3, L3-L4, L4-L5 interspaces. The amount and type of local anesthetic/intrathecal narcotic will be left to the discretion of the Anesthetist.
16162897|NCT01680900|Drug|vilazodone|capsules once/day for 8 weeks. Dose starts at 10 mg for 7 days, increases to 20 mg/day for 7 days, increases to 40 mg/day at week 3 of unimproved.
16162898|NCT01680900|Drug|placebo capsules|placebo capsules matched to drug capsules.
16162899|NCT01680887|Drug|Varenicline|
16162900|NCT01680887|Drug|Placebo|
16162935|NCT01680601|Procedure|Remote ischaemic preconditioning (RIPC)|RIPC will be performed by 3 cycles of 5 minute leg ischaemia induced by inflation of a blood pressure cuff to 40 mmHg above the patient's systolic pressure. This protocol will be performed at two phases: 24 hours before surgery and during anaesthesia immediately prior to surgery.
16162936|NCT01680601|Procedure|Placebo|
16162937|NCT01680588|Drug|[18F]NAV4694|
16241676|NCT01072214|Drug|Placebo|placebo
16162901|NCT01680874|Dietary Supplement|Probiotic|The intervention will consist of the subject taking the study medication once a day for 4 weeks. During hospitalization, patients will be followed daily for diarrhea history, record of concomitant medications, adverse effects (AEs), and their response to treatment using a stool diary. Upon discharge from the hospital, patients will be contacted through weekly phone calls to assess diarrhea history, record of concomitant medications, adverse effects (AEs), and their response to treatment using a stool diary. At weeks 4 and 8, a stool sample will be collected, and the stool diary will be reviewed.
16162902|NCT01680874|Dietary Supplement|Placebo|The intervention will consist of the subject taking the placebo once a day for 4 weeks. day for 4 weeks. During hospitalization, patients will be followed daily for diarrhea history, record of concomitant medications, adverse effects (AEs), and their response to treatment using a stool diary. Upon discharge from the hospital, patients will be contacted through weekly phone calls to assess diarrhea history, record of concomitant medications, adverse effects (AEs), and their response to treatment using a stool diary. At weeks 4 and 8, a stool sample will be collected, and the stool diary will be reviewed.
16162903|NCT01680861|Drug|Tacrolimus|Tacrolimus dosing (rTd) is planned, 0.1 mg/kg PO BID - beginning when serum Cr decreases to a level of <4 mg/dl (i.e., acceptable renal transplant function) postoperatively. Target tacrolimus trough levels during the first year post-transplant and thereafter will be 5-8 ng/ml.
16162904|NCT01680861|Drug|Everolimus|Everolimus initiated at 0.75 PO BID and will be adjusted in order to achieve target everolimus trough levels of 3-8 ng/ml.
16162905|NCT01680861|Drug|Enteric Coated Mycophenolate Sodium (EC-MPS)|EC-MPS 720 mg PO BID - beginning on 1st postoperative day.
16162906|NCT01680861|Drug|Corticosteroids|Corticosteroids will be given as per our center protocol, i.e., a bolus of 500 mg of Methylprednisolone intravenously at surgery and daily x2, followed by 1.0 mg/kg, then 0.5 mg/kg orally until weaned off completely by 7-10 days postoperatively - the plan is for corticosteroids to be discontinued by 7-10 days postoperatively in both groups.
16162907|NCT01680835|Device|EverFlex™ Self-Expanding Peripheral Stent System|Using the EverFlex™ Self-Expanding Peripheral Stent System to treat atherosclerotic superficial femoral artery (SFA) and proximal popliteal lesions 4-18 cm long in subjects with Rutherford Clinical Categories 2-4.
16162908|NCT01680809|Device|Compression stocking 15-20mmHg|Compression stocking with 15-20mmHg of compression
16162909|NCT01680809|Device|Compression stocking 20-30mmHg|Compression stocking with 20-30mmHg of compression
16162910|NCT01680796|Drug|Dovitinib|"Dose Level 0: 200 mg daily
~Dose Level 1: 300 mg daily
~Dose Level 2: 300 mg daily
~Dose Level 3: 400 mg daily
~Dose Level 4: 500 mg daily"
16162911|NCT01680796|Drug|Bortezomib|"Dose Level 0: 1.3 mg/m2 IV on days 1 and 8
~Dose Level 1: 1.3 mg/m2 IV on days 1 and 8
~Dose Level 2: 1.6 mg/m2 IV on days 1 and 8
~Dose Level 3: 1.6 mg/m2 IV on days 1 and 8
~Dose Level 4: 1.6 mg/m2 IV on days 1 and 8"
16162912|NCT01680796|Drug|Dexamethasone|Dexamethasone 20 mg will be given orally on Days 1, 2, 8, and 9 of each 21-day cycle.
16162913|NCT01680783|Device|Non invasive ventilation using a helmet hyperbaric device|"Patients randomized to the intervention group will receive noninvasive ventilation delivered via a latex-free helmet connected to the ventilator by conventional tubing.
~If endotracheal intubation is required, the helmet will be removed and the patient will be intubated without delay."
16162914|NCT01680783|Other|Noninvasive ventilation via facemask|Patients assigned to the conventional ventilation group will continue noninvasive ventilation via facemask
16162915|NCT01680757|Device|LARIAT Suture Delivery Device and Accessories|
16162916|NCT01680744|Other|Hypothermia|The intervention will take place after consent for donation and research has been obtained and hemodynamic stability has been achieved (mean arterial blood pressure > 60 mmHg for more than one hour without an increase in vasopressors). Organ donors in the experimental group will either be actively warmed or allowed to spontaneously reach a body temperature of 34 °C.
16162917|NCT01680718|Drug|Intranasal oxytocin|Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 24 IU oxytocin (Syntocinon, Novartis Pharmaceuticals). 5 puffs per nostril (1 puff = 2.4 IU oxytocin).
16162918|NCT01680718|Drug|Intranasal vasopressin|Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 20 IU vasopressin (American Regent Pharmaceuticals). 5 puffs per nostril (1 puff = 2 IU vasopressin).
16162919|NCT01680718|Drug|Intranasal placebo|Through the use of 1oz bottles attached with metered nasal pumps (1 puff = .1ml), participants will self-administer 5 puffs per nostril. Placebo consists of: 2 mls Glycerine and 3 mls purified water (methylparaben and propylparaben mixed according to purified water formula) for a total of 5 ml, which will be filtered with a 5mu filter (used previously; Bartz et al., 2010).
16162920|NCT01680705|Other|High Volume Saline Irrigation|High volume saline irrigation (240 ml)
16162921|NCT01680692|Drug|Ropivicaine|Infusion of local anesthetic for post-operative analgesia.
16162922|NCT01680692|Device|Continuous Femoral Nerve Catheter|Continuous femoral nerve catheter placed to deliver infusions of local anesthetic post-operatively.
16162923|NCT01680692|Device|Continuous Tibial Nerve Catheter|Continuous infusion of local anesthetic delivered through a tibial nerve catheter post-operatively.
16162924|NCT01680679|Biological|Inactivated Trivalent Influenza Vaccine (TIV)|
16162925|NCT01680679|Biological|Inactivated poliovirus vaccine (IPV), trivalent|
16162926|NCT01680666|Procedure|central line placement|central line placement
16162927|NCT01680666|Device|Ultrasound|Ultrasound guided central venous access
16162928|NCT01680653|Drug|Mini-glucagon|Mini dose glucagon given for glucose <70 mg/dl at a dose of 1unit/year of age
16162929|NCT01680653|Device|Remote monitoring|Provides real-time continuous glucose monitoring
16162930|NCT01680653|Dietary Supplement|Carbohydrates|16 grams of carbohydrate
16162931|NCT01680640|Dietary Supplement|Synbiotic|The synbiotic to be used is fructo-oligosacharide with a degree of polymerization < 10 at 4 g/twice a day (two sticks a day) plus Bifidobacterium animalis subsp. lactis BB-12 as minimum of 10 billion CFU/day (1 capsule a day).
16162932|NCT01680640|Dietary Supplement|Maltodextrin|
16162933|NCT01680627|Behavioral|CASI|
16162934|NCT01680614|Behavioral|CASI|
16162938|NCT01680562|Other|in-vivo skin tumor imaging via optical coherence tomography|optical coherence tomography imaging of skin lesion; digital dermoscopy imaging of skin lesion
16244732|NCT01048710|Other|No intervention|
16162939|NCT01680549|Drug|Gabapentin|Gabapentin 600mg PO pre-operatively and continued postoperatively 300 mg PO q8 hours x 3 days.
16162940|NCT01680536|Drug|maraviroc|
16162941|NCT01680523|Procedure|Radical hysterectomy|Piver-Rutledge type III hysterectomy New classification type C2 hysterectomy Open, vaginal, laparoscopic assisted, laparoscopic, robotic radical hysterectomy are all allowed
16162942|NCT01680523|Radiation|Tailored adjuvant therapy|After radical hysterectomy, intermediate risk group according to GOG protocol 92 criteria will receive adjuvant radiation therapy. High risk group will receive adjuvant chemoradiation therapy with weekly cisplatin (40mg/m2, IV for 6 cycles). Extended filed radiation therapy is allowed in case of common iliac lymph node or para-aortic lymph node metastasis. Intracavitary brachytherapy and nodal or parametrial boost is not allowed.
16162943|NCT01680523|Radiation|Primary chemoradiation therapy|Patient will receive primary radiation therapy including external pelvic irradiation, intracavitary brachytherapy, and parametrial or nodal boost. Extended filed radiation therapy is allowed in case of common iliac lymph node enlargement. Patients will receive concurrent weekly cisplatin (cisplatin 40mg/m2 for 6 cycles) during external radiation therapy.
16162944|NCT01680510|Dietary Supplement|Alga Dunaliella Bardawil|
16162945|NCT01680510|Other|Placebo (starch)|
16162946|NCT01680497|Device|Crosslinked hyaluronic acid dermal filler|All treatment details are at the discretion of the Investigator and should be guided by the Directions for Use. Up to 3 treatments will be administered: Initial treatment, optional top-up treatment at Day 14 post-initial treatment, and optional repeat treatment at Month 12 post-initial treatment.
16162947|NCT01680484|Dietary Supplement|Bitter chocolate|
16162948|NCT01680484|Dietary Supplement|Orange juice|
16162949|NCT01680471|Drug|Midazolam 0.03mg/kg|"This group will be injected intravenous midazolam 0.03mg/kg five minutes before the end of surgery.
~If emergence agitation is severe, the patients will be treated by psychological support from the parents or nurse and intravenous fentanyl 1㎍/kg."
16162950|NCT01680471|Drug|Midazolam 0.05mg/kg|"This group will be injected intravenous midazolam 0.05mg/kg five minutes before the end of surgery.
~If emergence agitation is severe, the patients will be treated by psychological support from the parents or nurse and intravenous fentanyl 1㎍/kg."
16162951|NCT01680471|Drug|Placebo|"This group will be injected intravenous normal saline five minutes before the end of surgery.
~If emergence agitation is severe, the patients will be treated by psychological support from the parents or nurse and intravenous fentanyl 1㎍/kg."
16162952|NCT01680458|Drug|Fluconazole|"Candidiasis infection: The recommended dosage in children is 3 mg/kg once daily.
~Cryptococcal infection: The recommended dosage in children is 6 mg/kg once daily. A dosage of 12 mg/kg once daily may be used, based on medical judgment of the patient's response to therapy.
~Prophylactic administration for deep mycosis on Hematopoietic stem cell transplantation: The recommended dosage in children is 12 mg/kg once daily.
~Absolute doses exceeding 600 mg/day are not recommended."
16162953|NCT01680432|Dietary Supplement|Probiotic fresh cheese|Participants in the intervention group were instructed to drink 30 grams of fresh cheese enriched with probiotics daily for 30 consecutive days.
16162954|NCT01680432|Dietary Supplement|Regular Cheese|
16162955|NCT01680419|Behavioral|Mission Reconnect|Multimedia package (audio, video, and print, web-based and downloadable to mobile devices) comprising an integrated program of (1) guided mind/body stress reduction and relaxation practices, (2) contemplative practices to engender and support appreciation, empathy and forgiveness for oneself and one's loved ones, and (3) video instruction in use of simple massage techniques with a partner for connection and stress reduction.
16162956|NCT01680419|Behavioral|PREP|"The Army's PREP for Strong Bonds program offers retreats for partnered soldiers to support reintegration and healthy relationships. PREP (Prevention and Relationship Enhancement Program) for Strong Bonds is a standardized, evidence-based program conducted in a weekend residential retreat format with experiential exercises. The Army Chaplain Corps trains chaplains to facilitate the program. The manualized program uses methods from cognitive behavioral therapy and communication-oriented marital enhancement programs developed by Markman et al. at the Denver University Center for Marital and Family Studies. Topics include communication, conflict management, commitment, friendship, sensuality, problem-solving, and emotional supportiveness, among others."
16162957|NCT01680406|Drug|Artemether-lumefantrine combination|
16162958|NCT01680406|Drug|Primaquine|
16162959|NCT01680406|Drug|Chloroquine|
16162960|NCT01680393|Device|Sequential compression device|a sequential compression device will be applied to the legs
16162961|NCT01680393|Other|TED stockings|TED stockings will be applied to the patients legs during surgery
16162962|NCT01680367|Procedure|wound care management|Receive transparent film dressing or Xeroform petroleum gel impregnated gauze dressing
16162963|NCT01680367|Procedure|wound care management|Receive native collagen wound dressing
16162964|NCT01680367|Other|questionnaire administration|Ancillary studies
16162965|NCT01680354|Procedure|ReLEx|
16162966|NCT01680354|Procedure|LASIK|
16162967|NCT01680341|Drug|insulin degludec/insulin aspart|Twice weekly self-titration at intervals of 3-4 days, based upon a single pre-breakfast and pre-dinner SMPG (self-measured plasma glucose) value. For subcutaneous (s.c., under the skin) administration.
16162968|NCT01680341|Drug|insulin degludec/insulin aspart|Once weekly self-titration based upon the lowest of 3 pre-breakfast and 3 pre-dinner SMPG (self-measured plasma glucose) values. For subcutaneous (s.c., under the skin) administration.
16162969|NCT01680328|Other|19 injections|Subjects will receive 19 injections in randomised order of which 13 will be in the abdomen and 6 in the thighs. Out of the 19 injections, 2 are needle insertions only. The remaining 17 injections represent different combinations of injection speed and volume of sodium chloride 0.9% solution for injection. The order of the injection speed and volume combinations will be blinded for the subject and the pain will be evaluated by the subject on a VAS (Visual Analogue Scale).
16162970|NCT01680328|Drug|sodium chloride 0.9% solution|Solution for injection.
16162971|NCT01680315|Behavioral|low calorie yogurt|all participants consumed twice the low-caloric food (once with the low-calorie information and once with the high-calorie information)
16162972|NCT01680315|Behavioral|high calorie yogurt|all participants consumed twice the high-caloric food (once with the low-calorie information and once with the high-calorie information)
16162973|NCT01680302|Behavioral|High intensity exercise|
16162974|NCT01680302|Behavioral|Moderate intensity exercise|
16162975|NCT01680302|Behavioral|Control|Advised to follow current guidelines for physical activity, but exercise on their own.
16162976|NCT01680289|Procedure|Three adhesive coats|After caries removal, enamel margins will be conditioned with phosphoric acid gel 37% by 15 seconds and dentin walls by 8 seconds. The etchant will be removed with use of water spray by 30 seconds. The water excess will be removed with a cotton pellet. The first layer of Prime & Bond 2.1 adhesive will be applied with a microbrush. After 20 seconds a second layer will be applied and after a similar period a third layer will be applied over cavity walls. Again, after 20 seconds, the layers will be gently air-dried and photopolymerized by 10 seconds with a LED photoactivation unit.
16162977|NCT01680289|Procedure|Two adhesive coats|After caries removal, enamel margins will be conditioned with phosphoric acid gel 37% by 15 seconds and dentin walls by 8 seconds. The etchant will be removed with use of water spray by 30 seconds. The water excess will be removed with a cotton pellet. The first layer of Prime & Bond 2.1 adhesive will be applied with a microbrush. After 20 seconds a second layer will be applied and after 20 seconds, the layers will be gently air-dried by 5 seconds. The two layers will be photopolymerized by 10 seconds with a LED photoactivation unit.
16162978|NCT01680276|Behavioral|PBS based staff training|"Please see published study protocol for more information:
~http://www.biomedcentral.com/1471-244X/14/219"
16162979|NCT01680276|Other|Treatment as Usual|http://www.biomedcentral.com/1471-244X/14/219
16162980|NCT01680263|Device|Kinesiotaping|"Use of kinesiotaping on the painful area in the form of space correction. Kinesiotaping was repeated for 3 weeks with 1week interval"
16162981|NCT01680263|Procedure|NSAIDs/Physical therapy|Use of non-steroidal anti-inflammatory drugs and 10 sessions of daily physical therapy.
16162982|NCT01680250|Drug|Sirolimus|Sirolimus administration for 12 months followed by conventional therapy alone for additional 12 months
16162983|NCT01680237|Behavioral|Cognitive behavior therapy|Treatment covers psychoeducation on the nature of anxiety and panic, interoceptive and intensified situational exposure exercises as well as identification and correction of maladaptive thoughts about anxiety and its consequences.
16162984|NCT01680237|Behavioral|Exposure in-vivo|Treatment covers psychoeducation on the nature of anxiety and panic, interoceptive and intensified situational exposure exercises.
16162985|NCT01680224|Behavioral|Healthy Weight|
16162986|NCT01680224|Behavioral|Project Health|
16162987|NCT01680224|Behavioral|Placebo Control|Participants will view a video on overweight and obesity
16162988|NCT01680211|Dietary Supplement|Salacia bark extract|
16162989|NCT01680211|Dietary Supplement|Salacia leaf extract|
16162990|NCT01680211|Dietary Supplement|Sesame seed extract|
16162991|NCT01680211|Behavioral|TLC|Lifestyle changes include diet, exercise, weight loss, etc.
16162992|NCT01680211|Other|Placebo|
16162993|NCT01680198|Drug|Paracalcitol|Patients in the experimental arm received 2 micrograms Paricalcitol capsules daily, for 12 weeks. This dose was adjusted based on clinical laboratory parameters and the maximum dose was 2 micrograms daily.
16162994|NCT01680198|Drug|placebo|
16162995|NCT01680185|Drug|Insulin lispro, Humalog (Eli Lilly) in insulin pump|all covered above
16162996|NCT01680185|Drug|Human insulin isophane, Humulin N (Eli Lilly)|all covered above
16162997|NCT01680185|Other|Standard of care|all covered above
16162998|NCT01680172|Drug|Ketamine|Single dose (0.5 mg/kg) of liquid ketamine 10mg/mL solution taken by mouth
16162999|NCT01680172|Drug|Placebo|Single dose of liquid placebo solution taken by mouth
16163000|NCT01680159|Drug|TA-650|
16163001|NCT01680146|Dietary Supplement|PRO+FAT|
16163002|NCT01680146|Dietary Supplement|PRO|
16163003|NCT01680133|Other|Hyperinsulinemic euglycemic clamp|
16163004|NCT01680120|Procedure|Continuous spinal anaesthesia|"Standard monitoring including continuous electrocardiogram, noninvasive automated arterial blood pressure and pulse oximetry will be applied.
~Subarachnoid puncture will be performed with a 18-gauge Tuohy needle at the L4-5 or L3-4 interspace using a midline approach. Three cm of a 22-gauge catheter will be introduced cephalad through the needle. The initial dose is arbitrarily chosen as 1 ml of 0.5 % isobaric bupivacaine on the basis of clinical experience, the local anaesthetic will be injected through the catheter over 5-10 s. After completion of injection the patients remain in the lateral position for 5 min and then will be returned to the supine position.
~Successive injections of 0.2 ml of 0.5 % isobaric bupivacaine will be performed every 15 min until a satisfactory sensory level is obtained (T12)."
16163005|NCT01680107|Drug|d-cycloserine|
16163006|NCT01680107|Drug|placebo|
16163007|NCT01680107|Behavioral|cognitive-behaviour therapy|
16163008|NCT01680094|Drug|Panobinostat|20 mg panobinostat will be administered orally on days 1, 3, and 5 (TIW) every other week (QOW) for a period of 8 weeks while maintaining background HAART
16163009|NCT01680081|Other|Adenosine stress dynamic CT perfusion|
16163010|NCT01680068|Procedure|Pars plana vitrectomy and postoperative air tamponade|Pars plans vitrectomy, ILM peeling and air tamponade. No postoperative face down positioning. All patients need to be pseudophakic prior to intervention.
16163011|NCT01680042|Drug|Phenytoin paste|
16163012|NCT01680042|Drug|Placebo|
16163013|NCT01680029|Device|PBASE-system 2.0|
16163014|NCT01680016|Biological|Zagreb|Subjects received Zagreb schedule (2-1-1) i.e. 4 vaccinations of Rabipur at days 1 , 8 and 22
16163015|NCT01680016|Biological|Essen|Subjects received Essen schedule (1-1-1-1-1) i.e. 5 vaccinations of Rabipur at days 1, 4, 8, 15 and 29
16163016|NCT01680003|Drug|Hepar-P|
16163017|NCT01680003|Drug|Placebo for Hepar-P|
16163018|NCT01679990|Biological|PLX-PAD Low dose|
16163019|NCT01679990|Biological|PLX-PAD high doses|
16163020|NCT01679990|Biological|Double Placebo|
16163021|NCT01679990|Biological|high dose +Placebo|
16163022|NCT01679977|Device|Vibrational-proprioceptive Resistance Exercise Training|
16163023|NCT01679977|Device|Neuromuscular Electrical Stimulation Training|
16163024|NCT01679964|Drug|Raltegravir switch|Isentress (400mg) bid + 2 NRTI (at least 2 nucleoside or nucleotide reverse transcriptase inhibitors and no other protease inhibitors)
16163025|NCT01679951|Drug|Placebo|Form=tablet, route=oral. Placebo will be administered once daily from week 0 to week 24.
16163060|NCT01679613|Drug|Ketoconazole|oral administration
16252970|NCT00987246|Drug|LAS106521|Topical
16163026|NCT01679951|Drug|JNJ-38518168 (3 mg)|Type=exact number, unit=mg, number=3, form=tablet, route=oral. JNJ-38518168 will be administered once daily up to 24 weeks.
16163027|NCT01679951|Drug|JNJ-38518168 (10 mg)|Type=exact number, unit=mg, number=10, form=tablet, route=oral. JNJ-38518168 will be administered once daily up to 24 weeks.
16163028|NCT01679951|Drug|JNJ-38518168 (30 mg)|Type=exact number, unit=mg, number=30, form=tablet, route=oral. JNJ-38518168 will be administered once daily up to 24 weeks.
16163029|NCT01679951|Drug|Methotrexate|Participants must have been treated with and tolerated Methotrexate (MTX) treatment at dosages from 10 to 25 milligram per week (mg/week) inclusive, for a minimum of 6 months prior to the date of signing the informed consent at screening and must have a stable MTX dose for a minimum of 8 weeks prior to the date of signing the informed consent at screening and continue to receive the same MTX dose at Week 0 through Week 24.
16163030|NCT01679938|Behavioral|primary obesity prevention|"Training of child care providers.
~Curriculum sessions for children. Child care providers will facilitate 12 interactive education sessions that focus on key obesity-related behaviors.
~Family outreach activities. Child care providers and research staff will communicate behavior change messages to families through ten take-home activities focused on key obesity-related behaviors and through monthly family workshops at the child care center.
~Maintenance activities. Over the six months following the main intervention, research staff will conduct eight booster sessions for the children and one booster session for the family that will build upon activities and behavior change messages of the main intervention."
16163031|NCT01679912|Other|phone to the call center|recommendations to phone to the call center for all the patients who have an acute attack
16163032|NCT01679899|Drug|Vildagliptin|Vildagliptin 50mg bid orally for 12 months
16163033|NCT01679899|Drug|Gliclazide MR|Gliclazide MR 60 or 120mg orally for 12 months
16163034|NCT01679886|Radiation|Rubidium PET|Rubidium PET
16163035|NCT01679873|Other|Assess one type of abstract in the randomized arm|Participants will be asked to assess only one abstract in his arm of randomization. Three reminders will be made
16163036|NCT01679860|Procedure|Clin A. CHOP-CAMPATH (Chemo-immunotherapy) + SCT|"Clin A:
~CHOP-Campath (CHOP-C) for 2 cycles (every 21 days): Doxorubicin 50mg/m2 day +1, Vincristin 1.4mg/m2 day +1, Cyclophosphamide 750mg/m2 day +1, prednisone 100mg/m2 PO on days +1 to +5; Campath-1H (alemtuzumab) dose escalation 3-10-20mg IV days - 2, - 1, 0 (first CHOP-C) or 30mg SC day 0 (second CHOP-C). Methotrexate 12.5mg IT, Ara-C 40mg IT, Dexamethasone 4mg IT on days + 1 and 21 (first and second CHOP-C).
~HYPER-C-HiDAM for 2 cycles: Methotrexate 1.5gr/m2 day +1; Cyclophosphamide 300mg/m2 every 12 hours days +2-3-4; ARA-C 2gr/m2 every 12 hours days +2-3-4; G-CSF 5μcg/kg/day starting from day +5 until peripheral blood stem cell harvest
~Myeloablative regimen followed by autologous transplantation or Reduced intensity conditioning followed by allogeneic transplantation."
16163037|NCT01679860|Drug|Clin B (CHOP- CAMPATH) Chemo-immunotherapy|"Clin B:
~CHOP-Campath (CHOP-C) for 6 cycles (every 21 days): Doxorubicin 50mg/m2 day +1, Vincristin 1.4mg/m2 day +1, Cyclophosphamide 750mg/m2 day +1, prednisone 100mg/m2 PO from day +1 to day +5¸ Campath-1H (alemtuzumab) 3-10mg IV on days - 1 and 0 ( first CHOP-C course) or 10mg SC on day 0 (for the following 5 C-CHOP courses). Methotrexate 12.5mg IT, Ara-C 40mg IT, Dexamethasone 4mg IT on day +1 of each CHOP-C course."
16163038|NCT01679821|Other|A questionnaire and a clinical examination|Seventy dental students of State University of West of Paraná - UNIOESTE, seventy patients treated at the UNIOESTE Dental Clinic that wore removable partial denture (partially edentulous) and seventy patients with double complete dentures treated in Center for Dental Specialties of Cascavel, Paraná, Brazil. Students in orthodontic treatment or with less than one year after the end of orthodontic treatment were excluded from the research. Patients wearing a complete denture in one maxillary and a removable partial denture in another maxillary, and patients wearing just one complete denture were not included in the research.
16163039|NCT01679795|Drug|Tibolone|
16163040|NCT01679795|Drug|Placebo|
16163041|NCT01679756|Procedure|Laparoscopic right hemicolectomy for cancer|After induction of anesthesia, a foley catheter and an NG tube will be inserted. All patients will have their NG tubes removed after the procedure. During the procedure patients will be placed in Trendelenburg position with 15 degrees of tilt and with a right side up (tilt to the left of 25 degrees). A Veres needle will be inserted and pneumoperitoneum induced and maintained at 12 mmHg for the entire duration of the procedure. Under direct vision, three 10-12mm trocars will be inserted in the left abdominal wall. The ileocolic vessels, the right colic vessels (when present), the right branch of the middle colic vessels and the right gastroepiploic vessels will be ligated intracorporeally at their origin using clips. Anastomosis are described in each arm description.
16163042|NCT01679743|Drug|Trastuzumab|Trastuzumab will be administered after GRN1005 in patients with HER2+ metastatic breast cancer.
16163043|NCT01679743|Drug|GRN 1005|GRN1005 will be administered at a dose of 550 mg/m2 as an IV infusion at a rate of 8.0 - 8.5 mL/minute on Day 1 of 21-day cycle ( 3 days) and a second dose will be given on the day of surgery (day 21) 3-6 h prior to surgery.
16163044|NCT01679717|Other|Early mobilisation after CMC1-surgery|Comparison of early (two weeks) and conservative (six weeks) mobilisation after operation. Comparison of rigid and soft thumb splint.
16163045|NCT01679704|Dietary Supplement|Food products|
16163046|NCT01679691|Other|epidural anesthesia|the group in whom all patients will be subjected to epidural anesthesia intra- and post-operative
16163047|NCT01679678|Device|PolyHeal 2|PolyHeal is a sterile medical device
16163048|NCT01679678|Device|Polyheal|PolyHeal is a sterile medical device that is comprised of negatively charged 5-micron polystyrene microspheres suspended in
16163049|NCT01679665|Biological|320U /0.5ml|inactivated vaccine(vero cell) against EV71 of 320U /0.5ml, two doses, 4 weeks interval
16163050|NCT01679665|Biological|0/0.5ml placebo|0/0.5ml placebo, two doses, 4 weeks interval
16163051|NCT01679652|Drug|Nebivolol|Tablet i blinded in capsula
16163052|NCT01679652|Drug|placebo|
16163053|NCT01679639|Drug|aleglitazar|Single dose of aleglitazar in Periods 1, 2, 3
16163054|NCT01679639|Drug|rifampicin|Single dose in Periods 1 and 2; multiple doses in Period 3
16163055|NCT01679613|Drug|Nintedanib|low or medium dose depending on pilot part
16163056|NCT01679613|Drug|Nintedanib|low dose oral administration
16163057|NCT01679613|Drug|Ketoconazole|oral administration
16163058|NCT01679613|Drug|Nintedanib|low dose oral administration
16163059|NCT01679613|Drug|Nintedanib|low or medium dose depending on pilot part
16163061|NCT01679600|Device|Feedback-controlled robotics-assisted treadmill exercise|Progressive cardiovascular exercise using feedback-controlled robotics-assisted treadmill exercise. The first training session is defined to start at 40% of peak work rate (determined from a previous exercise test) to approach 40% of heart rate reserve (Borg scale approximately 11-14). The intensity will then be adjusted on the basis of continuous heart rate data and rating of perceived exertion indications by modulating the target work rate in 5% increments for every subsequent session to reach the target intensity. The target heart rate is set at 40% to 70% of heart rate reserve.
16163062|NCT01679600|Device|Robotics-assisted treadmill exercise|Conventional robotics-assisted treadmill exercise, where therapists focus on gait quality only.
16163063|NCT01679587|Drug|Molidustat (BAY85-3934)|20 mg molidustat as a single tablet
16163064|NCT01679587|Drug|Placebo|Single oral dose of matching placebo will be given in each treatment arm
16163065|NCT01679574|Drug|Letrozole|•Drug: Letrozole tablets (Femara; Novartis Pharma, Switzerland) 2.5 mg letrozole daily from day 3 of the menses for 5 days
16163066|NCT01679574|Drug|Clomiphene|•Drug: CC (Clomid®; Global Napi Pharmaceuticals, Cairo, Egypt) 100 mg CC for 5 days starting from day 3 of menstruation
16163067|NCT01679574|Drug|Metformin|•Drug: metformin HCl (Cidophage®; CID,Cairo, Egypt) metformin HCl 1500 daily for 3 months
16163068|NCT01679561|Drug|intralipid|intravenous intralipid 20% is given to the patients known to be have either recurrent failed IVF, RPL
16163069|NCT01679548|Procedure|Single-port LAVH|
16163070|NCT01679548|Procedure|Three-port LAVH|
16163071|NCT01679535|Behavioral|nutrition and hygiene education|Monthly education sessions about child feeding and hygiene for mothers of young children, conducted by local Kenyan community health workers
16163072|NCT01679522|Procedure|single-port laparoscopic surgical staging|single-port laparoscopic surgical staging indluding total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection
16163073|NCT01679522|Procedure|Four-port laparoscopic surgical staging|Four-port laparoscopic surgical staging indluding total hysterectomy, pelvic lymph node dissection, and/or bilateral salpingooophorectomy, and/or para-aortic lymph node dissection
16163074|NCT01679509|Procedure|Single-port laparoscopic adnexal surgery|
16163075|NCT01679509|Procedure|Three-port laparoscopic adnexal surgery|
16163076|NCT01679496|Other|Food items|Food items with different fatty acid composition
16163077|NCT01679483|Drug|FloSeal application|At the completion of lymph node dissection, 2 vials of Floseal will be applied to each lymph node area.
16163078|NCT01679470|Device|AuroLase Therapy|Infusion of AuroShell particles followed by laser illumination for photothermal ablation of target lesions.
16163079|NCT01679457|Behavioral|ACT-Focused ERP|
16163080|NCT01679457|Behavioral|TAU-ERP|
16163081|NCT01679444|Procedure|Magnetic Resonance Spectroscopy|
16163082|NCT01679431|Diagnostic Test|Doppler-echocardiography|
16163083|NCT01679431|Radiation|Computed tomography|
16163084|NCT01679431|Other|Magnetic resonance imaging|
16163085|NCT01679431|Biological|Fasting blood sample|
16163086|NCT01679418|Device|Placement of a wound drain post surgery (Redon; Medicoplast)|The wound drain, type Redon Drainage 3.0 mm in diameter
16163087|NCT01679418|Other|No-drain after surgery|After surgery, no drain was put
16163088|NCT01679405|Drug|BIBW 2992|once daily per os
16163089|NCT01679392|Drug|Ropivacaine|Unilateral, single shot, ultrasound-guided, transversus abdominis plane block with 20 ml ropivacaine (7.5 mg/ml)
16163090|NCT01679379|Procedure|Absorbable suture group|Skin is closed with subcuticular stitches using [Polyglactin 910 absorbable, synthetic, braided suture]
16163091|NCT01679379|Procedure|Non absorbable suture group|Skin is closed with subcuticular stitches using Polypropylene non absorbable monofilament suture
16163092|NCT01679366|Drug|Placebo|1 tablet 2 times daily
16163093|NCT01679366|Drug|Probiotics|1 tablet twice daily
16163094|NCT01679353|Drug|caudal block|After inhalation induction of general anesthesia, caudal block was applied. Patients were randomly assigned in two groups. Normal saline 0.5mL added to ropivacaine 0.15% 1.0 ml/kg was administered to Group R , Magnesium 50mg (Magnesium 10% 0.5mL)added to ropivacaine 0.15% 1.0ml/kg to Group MR.
16163095|NCT01679353|Drug|normal saline 0.5ml|
16163096|NCT01679340|Drug|S-1|Mode of administration: orally (capsules) Dosing schedule:80mg/m2, Bid,D1-14,every 3 week,for 8-10cycles
16163097|NCT01679340|Drug|oxaliplatin|Mode of administration: intravenously Doseing schedule: 65 mg/m2 D1,D8,every 3 week, for 6 cycles
16163098|NCT01679340|Drug|cisplatin|Mode of administration: intravenously Dosing schedule: 75mg/m2 D1,every 3 week,for 6 cycle
16163099|NCT01679327|Drug|Oxaliplatin|
16163100|NCT01679327|Drug|Xeloda|
16163101|NCT01679327|Drug|Calcium folinate (CF)|
16163102|NCT01679327|Drug|5-FU|
16163103|NCT01679327|Drug|Bevacizumab|
16163104|NCT01679314|Device|AlphaCore device|Each study group will go under the same treatment regimen and assessments.
16163105|NCT01679301|Device|Pulse Dose (Sleep Mode)|SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.
16163106|NCT01679301|Device|Continuous Dose|SimplyGo Portable Oxygen Concentrator has two different modes of use 'Sleep Mode', or pulsed oxygen and continuous dose.
16163107|NCT01679288|Device|Ultrasound (Trademark:VScan; Manufacturer:General Electrics)|Standardized measurements were made and aorta was tried to be visualized in its entirety, and a minimum of three hard copy images were obtained: upper transverse subxiphoid section, lower transverse section for distal view of aorta, and longitudinal section (with origin of celiac trunk or superior mesenteric artery), determining the maximum diameter in centimeters (cm).
16163108|NCT01679275|Other|measuring cerebral oxygenation|
16163148|NCT01678937|Procedure|Blood Draw - CyA|"Blood drawn from 10 patients on cyclosporine (CyA) (40 ml = 8 tsp.)). Blood will be drawn at one time point for the following:
~Dendritic cell assays: myeloid vs. lymphoid (CD11c; CD123); maturation and ability to process antigens (CD83; CD205); markers that have been shown to induce regulatory T cells (ILT3; ILT4).
~Regulatory/Suppressor Cells (CD4+CD25+FOXP3+CD127low; and CD8+ CD28- FOXP3+CD127low cells).
~HLA microchimerism & HLA G"
16163267|NCT01678053|Drug|onabotulinumtoxinA|Botulinum toxin A is injected into the larynx in order to treat vocal fold granulomas.
16163109|NCT01679262|Device|Guedel type color-coded OPAs|The OPAs was used four different sizes as No. 8 (80 mm, green), 9 (90 mm, yellow), 10 (100 mm, red), and 11 (110 mm, orange) in regular sequence. The curvilinear distance from the incisors to the tip of the epiglottis was measured by FOB (Olympus LF-GP; Olympus Optical Co., Tokyo, Japan) with tape marking via each size of OPAs. The distance from the distal end of OPA to the tip of the epiglottis was calculated by the difference between measured distance from the incisors to the tip of the epiglottis via each OPA by FOB and typical distance from the flange to distal end of each OPA via inside tube of OPA. When the size of OPAs was longer than distance from the incisors to the tip of the epiglottis, OPAs were partly withdrawn and repositioned the distal end of OPAs is placed just above the tip of epiglottis. Then, the length from the incisors to the flange of OPAs was measured. .
16163110|NCT01679236|Behavioral|Mindfulness Training for Smokers|The provides the Mindfulness Training for Smokers intervention (7 weeks long).
16163111|NCT01679236|Behavioral|Interactive Learning for Smokers|This provides the Interactive Learning for Smokers intervention (7 weeks long).
16163112|NCT01679210|Behavioral|Lifestyle Intervention|Stage-matched physical activity and diet intervention materials and health education.
16163113|NCT01679197|Drug|Metreleptin|
16163114|NCT01679158|Device|Using The IOP system from USGI to place suture anchors|"Sutures are placed in the distal body in one of three randomized techniques:
~A = reduction in ring opening to antrum using plications B = continuous horizontal row, running from distal body into proximal antrum C = Control. Current V shape as Control"
16163115|NCT01679132|Device|BAROSTIM NEO System and Medical Management|"Experimental: Device and Medical Management
~Subjects have been implanted with the BAROSTIM NEO System and receive optimal medical management, including drugs to be determined by the subject's physician. Drug types include: Loop Diuretics; Thiazide Diuretics; Potassium-sparing Diuretics; Aldosterone receptor blockers; Beta-blockers; Beta-blockers with intrinsic sympathomimetic activity; Combined alpha- and beta-blockers; ACE inhibitors; Angiotensin II antagonists; Calcium channel blockers- non-Dihydropyridines; Calcium channel blockers- Dihydropyridines; Alpha1-blockers; Central alpha2-agonists and other centrally acting drugs; Direct vasodilators."
16163116|NCT01679119|Drug|Cyclophosphamide|Cyclophosphamide 750mg/m2 IV, given day 1
16163117|NCT01679119|Drug|Vincristine|Vincristine 1.4mg/m2(max 2mg)IV given day 1
16163118|NCT01679119|Drug|Prednisolone|Prednisolone 100mg OD Oral given days 1-5
16163119|NCT01679119|Drug|Rituximab|Rituximab 375mg/m2 IV given day 1
16163120|NCT01679119|Drug|Inotuzumab Ozogamicin|Inotuzumab Ozogamicin 0.8mg/m2 IV given on day 2
16163121|NCT01679119|Drug|Gemcitabine|Gemcitabine up to 1g/m2 IV given day 1 and day 8 (Patients with ECOG PS 0-1: starting dose: 875mg/m2 (1st cycle). If tolerated can be escalated to 1g/m2 in cycle 2 and subsequent cycles. Patients with ECOG PS 2: starting dose 750mg/m2 (1st cycle). If tolerated can be escalated to 875mg/m2 in cycle 2 and then escalated to 1g/m2 in cycle 3 and subsequent cycles.)
16163122|NCT01679106|Other|TAP catheter with Ropivicaine|Patients will receive TAP catheter with continuous infusion of Ropivicaine.
16163123|NCT01679106|Other|Fentanyl IV PCA and placebo TAP catheter|Patients will receive placebo TAP catheter with Fentanyl IV PCA.
16163124|NCT01679093|Drug|ondansetron|ondansetron: 4 mg intravenous administration afer the induction of anesthesia.
16163125|NCT01679093|Drug|Droperidol|droperidol: 1.25 mg intravenous administration after the induction of anesthesia.
16163126|NCT01679093|Drug|Dexamethasone|dexametasone: 4 mg intravenous administration after the induction of anesthesia.
16163127|NCT01679080|Drug|Zoledronic acid|antiresorptive and calcium and vitamin D
16163128|NCT01679080|Drug|Teriparatide|anabolic and calcium and vitamin D
16163129|NCT01679080|Other|No active treatment|Calcium and vitamin D
16163130|NCT01679067|Procedure|colonoscopy with endoscopic biopsies|
16163131|NCT01679041|Drug|Alemtuzumab|Alemtuzumab 10 mg given IV on day 1 of the 5 day conditional regimen
16163132|NCT01679041|Drug|Fludarabine|Fludarabine 25mg/m2 daily given IV on days 1-5 of the 5 day conditioning regimen
16163133|NCT01679041|Drug|Cyclophosphamide|Cyclophosphamide is given 3 gm/m2 for mobilization, and then repeated during 5 day conditioning regimen w/ doses of 50mg/kg/day on days 1-4
16163134|NCT01679028|Drug|T89 Group A|150mg single dose on day 1
16163135|NCT01679028|Drug|Placebo Group A|150mg single dose
16163136|NCT01679028|Drug|Placebo Group B|300mg single dose
16163137|NCT01679028|Drug|T89 Group B|300mg single dose
16163138|NCT01679028|Drug|Placebo Group C|225mg bid
16163139|NCT01679028|Drug|T89 Group C|225mg bid
16163140|NCT01679002|Drug|BIA 2-093|
16163141|NCT01679002|Drug|Oxcarbazepine|
16163142|NCT01678976|Drug|BIA 2-093|Tablets containing BIA 2-093 in doses of 300 and 600 mg
16163143|NCT01678976|Drug|Oxcarbazepine|Tablets containing 300 mg and 600 mg of Trileptal®
16163144|NCT01678963|Drug|Squalamine lactate|Ophthalmic solution 0.2%
16163145|NCT01678963|Drug|Vehicle control|Ophthalmic solution vehicle control
16163146|NCT01678937|Procedure|Blood Draw - Rapamycin|Ten calcineurin-inhibitors (CNI) monotherapy or dual therapy (CNI+MMF) patients will have blood taken (40 ml=8 tsp.) 2 wks. prior to conversion, 3-6 months post successful conversion. 1) Regulatory/Suppressor Cells (CD4+CD25+FOXP3+CD127low; and CD8+ CD28-FOXP3+CD127low cells). 2) Dendritic cell assays: myeloid vs. lymphoid (CD11c; CD123); maturation and ability to process antigens (CD83; CD205); markers shown to induce regulatory T cells (ILT3; ILT4), 3) Soluble HLA G, and 4) Liver function/drug levels. If problems develop during conversion (e.g. acute rejection, significant drug side effects) requiring discontinuation of rapamycin, MMF and/or reversion to CNI therapy, assays will not be performed. Monthly liver function/drug levels performed after successful conversion (standard of care).
16163147|NCT01678937|Procedure|Blood Draw from Control Subjects|"Ten healthy individuals will have blood drawn (40 ml = 8 teaspoons (tsps.)).Blood will be drawn at one time point for the following:
~Dendritic cell assays: myeloid vs. lymphoid (CD11c; CD123); maturation and ability to process antigens (CD83; CD205); markers that have been shown to induce regulatory T cells (ILT3; ILT4).
~Regulatory/Suppressor Cells (CD4+CD25+FOXP3+CD127low; and CD8+ CD28- FOXP3+CD127low cells).
~HLA microchimerism & HLA G"
16163180|NCT01678742|Dietary Supplement|High-protein diet|"The high-protein diet is made up of 50% carbohydrate, 40% of protein and 10% of fat, providing 480 kcal.
~A protein part of the high-protein diet is mostly composed of a grilled Jeju red horsehead fish, a special product of Jeju island in Korea."
16163149|NCT01678937|Procedure|Blood Draw - Tacrolimus|"Blood drawn from 5 patients on Tacrolimus (40 ml = 8 tsp.) at one time point for the following:
~Dendritic cell assays: myeloid vs. lymphoid (CD11c; CD123); maturation and ability to process antigens (CD83; CD205); markers that have been shown to induce regulatory T cells (ILT3; ILT4).
~Regulatory/Suppressor Cells (CD4+CD25+FOXP3+CD127low; and CD8+ CD28- FOXP3+CD127low cells).
~HLA microchimerism & HLA G"
16163150|NCT01678937|Procedure|Blood Draw - MMF|"Blood will be drawn from 10 patients on mycophenolate mofetil (MMF) (40 ml or the equivalent of 8 teaspoons). Blood will be drawn at one time point for the following analysis:
~Dendritic cell assays: myeloid vs. lymphoid (CD11c; CD123); maturation and ability to process antigens (CD83; CD205); markers that have been shown to induce regulatory T cells (ILT3; ILT4).
~Regulatory/Suppressor Cells (CD4+CD25+FOXP3+CD127low; and CD8+ CD28- FOXP3+CD127low cells).
~HLA microchimerism & HLA G"
16163151|NCT01678937|Procedure|Blood Draw - Rapamycin|"Blood drawn from 10 patients on rapamycin (40 ml = 8 tsp.)) at one time point for the following:
~Dendritic cell assays: myeloid vs. lymphoid (CD11c; CD123); maturation and ability to process antigens (CD83; CD205); markers that have been shown to induce regulatory T cells (ILT3; ILT4).
~Regulatory/Suppressor Cells (CD4+CD25+FOXP3+CD127low; and CD8+ CD28- FOXP3+CD127low cells).
~HLA microchimerism & HLA G"
16163152|NCT01678924|Drug|AGN-214868|AGN-214868 given as injections into the area of pain on Day 1.
16163153|NCT01678924|Drug|AGN-214868 Placebo (Vehicle)|AGN-214868 placebo (vehicle) given as injections into the area of pain on Day 1.
16163154|NCT01678911|Drug|Gralise|"Subjects will start at 600mg and titrate up by 600mg a week for two weeks (to 1800mg), then remain on 1800mg steady state dose of medication (or placebo pills) for 2 weeks. If intolerable side effects occur, the dose may be reduced to last tolerable dose at the discretion of the PI. A 2-week down-titration will be used. Subjects will have 1 week of wash-out before repeating the above procedure for the other arm of the study (placebo or medication)."
16163155|NCT01678898|Drug|PRX-102|
16163156|NCT01678885|Behavioral|Digital Photography of Foods|The digital photography of foods method was developed to unobtrusively measure energy intake in naturalistic settings (e.g., cafeterias). Participants will be provided with cell-phones with digital cameras and cellular network capability. Participants were trained to take pictures of their food selection and plate waste and to send these pictures to the researchers over the cellular network. The participant will collect data in free-living conditions and these data will be collected in near real time.
16163157|NCT01678885|Other|doubly labeled water|Doubly labeled water, considered the gold standard for measuring energy intake in humans, was used to measure total daily energy expenditure during free-living conditions. DLW is used to obtain an accurate measure of total daily energy expenditure, which is equal to energy intake during energy balance.
16163158|NCT01678885|Device|IDEEA|The Intelligent Device for Energy Expenditure and Activity (IDEEA) will be used to measure the time spent engaging in active vs. sedentary behaviors, and the energy costs of these behaviors.
16163159|NCT01678885|Behavioral|low-calorie diet|Participants will be instructed to consume five packets of Health One per day, which provides 800 kcal and 125% of Recommended Daily Intake of vitamins and minerals. Additionally participants will be instructed to consume a meal consisting of 200 kcal to 350 kcal daily, which could consist of a portion-controlled meal replacement or a home-cooked meal. Participants will meet with a Registered Dietitian at weeks 0, 2, 4, and 6 and receive instructions on adhering to the meal plan.
16163160|NCT01678885|Device|Actical|The Actical will be used to measure the time spent engaging in active vs. sedentary behaviors, and the energy costs of these behaviors.
16163161|NCT01678885|Device|Sensewear Armband|The Sensewear armband will be used to measure the time spent engaging in active vs. sedentary behaviors, and the energy costs of these behaviors.
16163163|NCT01678846|Behavioral|Good School Toolkit|The Toolkit uses a six step process to create a school wide intervention that engages teachers, students, administration, and parents to reflect on how they can promote quality of education in their school. The Toolkit articulates complex ideas (what is a good learning environment, a good teacher, how to create positive discipline without using violence) through booklets, posters and school initiated learning processes. Specific modules on alternative discipline techniques and how staff can use positive discipline are included in the Toolkit. The intervention includes sessions on knowledge, attitudes and opportunities to practice new behavioural skills. Work is led by teachers and students, and supported by visits from Raising Voices staff. The Toolkit can be reviewed at (http://www.raisingvoices.org/children/good_school_toolkit.php).
16163164|NCT01678820|Drug|Sitagliptin/Simvastatin FDC|Sitagliptin 100 mg/Simvastatin 40 mg fixed-dose combination tablet
16163165|NCT01678820|Drug|Sitagliptin|Sitagliptin 100 mg tablet
16163166|NCT01678820|Drug|Simvastatin|Simvastatin 40 mg tablet
16163167|NCT01678820|Drug|Placebo to sitagliptin|Matching placebo to sitagliptin 100 mg tablet
16163168|NCT01678820|Drug|Placebo to simvastatin|Matching placebo to simvastatin 40 mg tablet
16163169|NCT01678820|Drug|Placebo to Sitagliptin/Simvastatin FDC|Matching placebo to sitagliptin 100 mg/simvastatin 40 mg FDC tablet
16163170|NCT01678820|Drug|Metformin|Participants will continue on their stable, pre-screening metformin daily dose of >= 1500 mg for at least 12 weeks prior to randomization and during the study
16163171|NCT01678820|Drug|Glimepiride|Following randomization, participants requiring glycemic rescue may receive open-label glimepiride initiated at a dose of 1 mg/day or 2 mg/day which may be up-titrated to 6 mg/day taken once daily with breakfast or the first main meal of the day.
16163172|NCT01678807|Biological|MK-8237 6 DU|
16163173|NCT01678807|Biological|MK-8237 12 DU|
16163174|NCT01678807|Biological|Placebo|
16163175|NCT01678794|Drug|Candesartan|4 mg once a day up to 13 day. dose will be doubled every 14-18 days as tolerated to a goal of 16 mg a day or highest dose tolerated
16163176|NCT01678794|Drug|Placebo|4 mg once a day up to 13 day. dose will be doubled every 14-18 days as tolerated to a goal of 16 mg a day or highest dose tolerated
16163177|NCT01678755|Drug|ABT-126|ABT-126 Low Dose
16163178|NCT01678755|Drug|ABT-126|ABT-126 High Dose
16163179|NCT01678755|Drug|Placebo|Placebo
16163181|NCT01678742|Dietary Supplement|Standard diet|The standard diet is made up of 60% carbohydrate, 20% of protein and 20% of fat, providing 480 kcal.
16163392|NCT01676987|Drug|Budesonide|Delivered dry powder inhaler for 12 weeks.
16163182|NCT01678716|Behavioral|EHC + BCC|This arm includes home visits to mothers with infants and young children. Frontline health workers will counsel and support mothers in relation to breastfeeding and complementary feeding practices
16163183|NCT01678716|Dietary Supplement|Micronutrient powders|"In this intervention arm, frontline health workers will visit households and promote and sell micronutrient powders to them. The micronutrient powder is sold by the brand name Pushtikona in Bangladesh and contains 15 micronutrients including iron, zinc, vitamin A, vitamin C, and others."
16163184|NCT01678716|Behavioral|Mass media|A nationwide mass media campaign of TV and radio spots on infant and young child feeding practices will be aired in 2011, 2012 and 2013. All intervention arms will be exposed to this campaign.
16163185|NCT01678703|Device|Laminaria, MedGyn Products, Inc. USA.|Insertion of Hygroscopic laminarias into the cervical canal for preparation prior to late surgical abortion. The number of laminarias is according to the cervical compliance.
16163186|NCT01678703|Drug|Misoprostol|Cervical preparation with vaginal Misoprostol 600 mcg overnight the day before the abortion
16163187|NCT01678690|Drug|Gemcitabine HCl Oral Formulation|Gemcitabine HCl Oral Formulation 80 mg/vial Subjects will be treated on Day 1 of the 7-day study treatment period
16163188|NCT01678677|Biological|NTHI vaccine GSK2838500A (formulation 1)|Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
16163189|NCT01678677|Biological|NTHI vaccine GSK2838501A (formulation 2)|Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
16163190|NCT01678677|Biological|NTHI vaccine GSK2838502A (formulation 3)|Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
16163191|NCT01678677|Biological|NTHI vaccine GSK2838503A (formulation 4)|Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
16163192|NCT01678677|Biological|NTHI vaccine GSK2838504A (formulation 5)|Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
16163193|NCT01678677|Biological|NTHI vaccine GSK2838505A (formulation 6)|Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
16163194|NCT01678677|Biological|NTHI vaccine GSK2838508A (formulation 7)|Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
16163195|NCT01678677|Biological|NTHI vaccine GSK2838509A (formulation 8)|Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
16163196|NCT01678677|Drug|Placebo comparator|Intramuscular vaccination in the deltoid region of the non-dominant arm according to protocol schedule.
16163197|NCT01678664|Drug|Everolimus|10 mg per day of everolimus during 24 months or until progression disease
16163198|NCT01678664|Device|embolization|2 sessions embolization with spheric particles
16163199|NCT01678664|Drug|Doxorubicin|2 sessions chemoembolization with 10 mg of lipiodol with 100 mg of doxorubicine
16163200|NCT01678651|Procedure|Stimulation with human FSH|Human FSH
16163201|NCT01678651|Procedure|Stimulation with recombinant FSH|Recombinant FSH
16163202|NCT01678638|Procedure|IH repair before NICU discharge|The IH repair is performed prior to NICU discharge (within 1-2 weeks of enrollment and randomization)
16163203|NCT01678638|Procedure|IH repair at 55-60 weeks post-menstrual age|The IH repair will be performed as an outpatient between approximately 55-60 weeks post-menstrual age.
16163204|NCT01678625|Device|Train-of-four ratio calculation (T4-EMG)|TOF ratios will be compared between the EMG and AMG groups
16163205|NCT01678612|Other|Copper-alloy surfaced objects|Room assigned to the Experimental arm will be furnished with copper-alloy surfaced objects,i.e. bed-rails, bed-rail levers, IV poles, nurse workstation, HCW clipboards, sink handles.
16163206|NCT01678599|Drug|Benznidazole|All patients participating in this study will be treated with Benznidazole, 5mg/Kg/day PO BID for 60 days with a maximum daily dose of 300mg, as per routine care provided by MSF in rural communities in Aiquile. For patients > 60 kg, the total dose should be calculated (5mg/Kg x Weight x 60 days) and treatment duration should be adjusted/prolonged accordingly. This treatment is in accordance with the local recommendations from the Ministerio de Salud y Deportes de Bolivia.
16163207|NCT01678586|Other|Acupuncture|In true acupuncture the needles penetrate the skin.
16163208|NCT01678586|Other|Sham Acupuncture|In sham acupuncture the needles do not penetrate the skin.
16163209|NCT01678586|Drug|Gabapentin|Gabapentin is a commonly prescribed drug used to treat neuropathic pain.
16163210|NCT01678586|Drug|Sham Gabapentin|Benadryl or diphenhydramine is used as a placebo as it could mimic some common side effects of gabapentin (i.e. sedation, drowsiness, lightheadedness)
16163211|NCT01678573|Drug|Treatment A: abiraterone acetate|250 mg/day tablet administered orally on Day 1 of each treatment period.
16163212|NCT01678573|Drug|Treatment B: abiraterone acetate|500 mg/day tablets administered orally on Day 1 of each treatment period.
16163213|NCT01678573|Drug|Treatment C: abiraterone acetate|1000 mg/day tablets administered orally on Day 1 of each treatment period.
16163214|NCT01678560|Device|Monitoring every 3 months by face-to-face visits|These patients will be monitored on a 3-month, 6-month, 9-month and 12-month intervals with scheduling face-to-face visits. Adherence and efficacy data will only be assessed by the clinician at these intervals.
16163215|NCT01678560|Device|Frequent remote monitoring|These patients will be monitored using wireless modems as the method to obtain adherence and efficacy and follow-up phone calls
16163216|NCT01678547|Device|Robot-assisted walking|The practice will included an add-on robot-assisted walking therapy at variable speeds for 40 min with a partial body weight support (BWS). All participants will start with 30-40% BWS and an initial treadmill speed of 1.5 km/h speed will be increased to a range of 2.2 to 2.5 km/h and the BWS % will be decreased.
16163217|NCT01678547|Device|Treadmill Training|The practice will included an add-on treadmill walking therapy at variable speeds for 40 min with a partial body weight support (BWS). All participants will start with 30-40% BWS and an initial comfortable treadmill speed and the speed will be increased to a range of 1,0 to 2.5 km/h and the BWS % will be decreased.
16163218|NCT01678547|Other|Ground treatment|The practice will included ground walking therapy s for 40 min with therapist support.
16163219|NCT01678534|Drug|Allogenic mesenchymal stem cells from adipose tissue|
16163220|NCT01678534|Drug|Placebo|
16163266|NCT01678066|Device|Bilateral cardiac output|
16163221|NCT01678521|Procedure|LDL-apheresis|The acronym H.E.L.P. stands for Heparin-induced Extracorporeal Low-density-lipoprotein Precipitation. Antecubital veins served as blood access. The mean blood volume processed per session is of approximately 3000 ml.
16163222|NCT01678495|Other|Sulfur hexafluoride + ultrasounds|
16163223|NCT01678495|Drug|Recombinant tissue plasminogen activator|
16163224|NCT01678482|Device|light based device for treatment of acne|
16163225|NCT01678469|Other|blood sample|
16163226|NCT01678443|Biological|indium In 111 anti-CD45 monoclonal antibody BC8|Given IV
16163227|NCT01678443|Radiation|yttrium Y 90 anti-CD45 monoclonal antibody BC8|Given IV
16163228|NCT01678443|Procedure|peripheral blood stem cell transplantation|Undergo autologous peripheral blood stem cell transplant
16163229|NCT01678430|Drug|Ofatumumab|
16163230|NCT01678430|Drug|Chlorambucil|
16163231|NCT01678430|Drug|Bendamustine|
16163232|NCT01678417|Drug|131I-rituximab|
16163233|NCT01678404|Drug|131I-rituximab|
16163234|NCT01678391|Procedure|Common bile duct stone removal without fluoroscopy.|ERCP stone extraction technique without fluoroscopy involves: (1) catheter or catheter with wire access into the bile duct, (2) confirmation of biliary access with catheter aspiration of bile, (3) performance of endoscopic biliary sphincterotomy or balloon dilation to widen the bile duct opening to permit stone removal, (4) stone removal - number of stones seen on EUS should match the number removed.
16163235|NCT01678378|Behavioral|SHARP Intervention|Providers and staff located in high school school health centers (i.e., nurse practitioners, nurses,physicians, health educators, medical assistants) will be trained to address adolescent relationship abuse with school health center clients using knowledge, skills, and resources gained through the SHARP Intervention training. The training includes strategies to help youth recognize adolescent relationship abuse among themselves and their peers, to learn strategies to increase safety (harm reduction), and to utilize adolescent relationship abuse-related resources.
16163236|NCT01678365|Drug|ceftriaxone, metronidazole/ampicillin, gentamicin, and metronidazole|
16163237|NCT01678352|Biological|Tumor Lysate Vaccine|Cohort 1 Cohort 2 Cohort 3
16163238|NCT01678352|Drug|Imiquimod|Cohort 1 Cohort 2 Cohort 3
16163239|NCT01678326|Procedure|EUS-Rendezvous or direct intervention|
16163240|NCT01678326|Procedure|Advanced ERCP Biliary Access Techniques|
16163241|NCT01678313|Drug|Doxazosin 4 mg daily plus Celecoxib 200 mg every day (QD)|Study group
16163242|NCT01678313|Drug|Doxazosin 4 mg every day (QD)|Control group
16163243|NCT01678287|Drug|ASP1941|oral
16163244|NCT01678287|Drug|Placebo|oral
16163245|NCT01678235|Drug|Insulin glulisine|
16163246|NCT01678235|Drug|Insulin aspart|
16163247|NCT01678209|Other|fMRI scans|2 fMRI scans 6-8 weeks apart
16163248|NCT01678209|Drug|Atomoxetine arm|Flexible dose titration with atomoxetine prescribed at weekly visits for 6-8 weeks
16163249|NCT01678209|Drug|Methylphenidate arm|Flexible dose titration with methylphenidate for 6-8 weeks, with optional post study stabilization visits.
16163250|NCT01678196|Behavioral|VA-CRAFT|VA-CRAFT is an on-line training program that teaches family members how to communicate and interact with Veterans to promote their engagement in needed mental health services for PTSD or Alcohol Use Disorders. 12 on-line sessions.
16163251|NCT01678196|Other|Control|Participants will have the opportunity to complete the VA-CRAFT training program after 3 months; otherwise no intervention
16163252|NCT01678183|Behavioral|Monthly Financial Incentive|A cash payment.
16163253|NCT01678183|Behavioral|Final Financial Incentive|One-time payment in cash for each full percentage of hemoglobin A1c decrease over the eight-month period of the study.
16163254|NCT01678144|Device|Mitral valve repair using the Medtentia Annuloplasty Ring (MAR)|
16163255|NCT01678131|Drug|Vaniprevir 600 mg|Vaniprevir capsules, were administered orally, twice per day (BID) to achieve a final daily dose of 600 mg on Days 1 through 6; and a single dose of 600 mg, orally, on Day 7.
16163256|NCT01678131|Biological|Peg-IFN alfa-2b|Peg-IFN alfa-2b was administered at 1.5 µg/kg per week by subcutaneous injections on Days 1, 8, 15 and 21
16163257|NCT01678131|Biological|Ribavirin|Ribavirin capsules were administered on Days 1-21, orally, twice daily for a total daily dose of 600 - 1400 mg, depending on the participant's weight
16163258|NCT01678131|Procedure|Liver samples from FNA|Liver samples were collected from Day 7 up to Day 10 by FNA at 3 of 5 specified postdose timepoints.
16163259|NCT01678131|Drug|Vaniprevir 300 mg|Vaniprevir capsules were administered orally, twice per day to achieve a final daily dose of 300 mg on Days 1 through 6; and a single dose of 300 mg, orally, on Day 7.
16163260|NCT01678131|Procedure|Liver samples from CNB|Liver samples were collected from Day 8 up to Day 10 by CNB at 1 of 3 specified postdose timepoints.
16163261|NCT01678118|Behavioral|Patient Navigator|The pt navigator will phone (email, text, or other preferred method of contact) pts prior to the date of previously set individual goals (e.g. going to an appt, getting their cessation medications filled, etc) as a reminder & to discuss barriers such as finances, transportation or ambivalent motivation. In this manner, pts receive navigation services tailored to their individual needs & barriers. Once pts are connected with a cessation service (defined as either using cessation medication or at least 1 contact with a Quitline or community-based cessation counselor)or provider-prescribed cessation medication usage, continues the navigation intervention will be considered complete. W/I the 3 month engagement period, pts will receive up to 6 contacts from the Pt Navigator following referral from primary care provider. Consistent with recommended pt navigation practice, the navigator will provide feedback to primary care provider regarding cessation services that the pts are receiving.
16163262|NCT01678105|Drug|Dovitinib|Treatment continued until Disease Progression, Toxicity, or patient withdrawal
16163263|NCT01678092|Biological|omalizumab|
16163264|NCT01678079|Dietary Supplement|Encapsulated Calcium|The intervention is a multi-micronutrient powder containing enteric-coated calcium carbonate, in addition to ferrous fumarate (60 mg of elemental iron) and folic acid (400 µg).
16163265|NCT01678079|Dietary Supplement|Non-capsulated Calcium|The comparator/control intervention is a micronutrient powder containing non-coated calcium (500, 1000 or 1500 mg elemental calcium from calcium carbonate), ferrous fumarate (60 mg of elemental iron) and folic acid (400 µg). This product will be similar in Ca dose, appearance, taste and texture to the experimental formulation but will not include the enteric-coating.
16163268|NCT01678053|Drug|omeprazole (proton pump inhibitor)|Standard therapy of anti-reflux medications using omeprazole or equivalent PPI.
16163269|NCT01678027|Drug|Placebo|Lansoprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 1 week.
16163270|NCT01678027|Drug|LAC triple therapy|Lansoprazole 30 mg, amoxicillin 1,000 mg, and clarithromycin 500 mg, all twice a day for 1 week.
16163271|NCT01678014|Procedure|Deep Brain Stimulation(DBS)|Deep Brain Stimulation(DBS)is a neurosurgical procedure which include the implantation of deep brain electrodes and the connect to an implantable pulse generator (IPG) that is implanted below the collarbone.
16163272|NCT01678014|Procedure|Capsulotomy|
16163273|NCT01678001|Drug|Xeomin|Group A will consist of 25 patients that receive Xeomin. Group B will contain the other 25 patients that receive the placebo saline solution. Post-injection treatment will be kept the same between the two groups. This will only consist of plantar fascial stretching done 3 times daily.
16163274|NCT01677988|Drug|Neo-adjuvant Chemotherapy|"Modified FOLFIRINOX chemotherapy Day 1 and Day 15 of 28 day cycles, for three (3) cycles with growth factor support.
~Restaging # 1. (CT or MRI; use same modality as baseline staging unless otherwise indicated by Study Team)
~Progressive Disease (PD) → Off study. Subsequent treatment per patient's primary MD.
~Stable Disease (SD) or Tumor Response → Continue to Registration #2 for Chemoradiation."
16163275|NCT01677988|Radiation|Chemoradiation|"Chemoradiation may be administered at selected approved CTN sites.
~Determination of resectability as reviewed and documented by MUSC-HCC GI Tumor Board.
~Unresectable → Off study. Subsequent treatment per patient's primary MD.
~Resectable → Continue to Registration #3 for Surgical Resection"
16163276|NCT01677988|Procedure|Surgical Resection|"Meets criteria for resectable* →pancreaticoduodenectomy (POD)
~At time of resection, snap frozen tumor specimen sent for correlative biomarker studies"
16163277|NCT01677975|Procedure|FNA (fine needle aspiration)|
16163278|NCT01677962|Biological|Poly-ICLC|
16163279|NCT01677962|Biological|dendritic cell|
16163280|NCT01677949|Drug|Clofarabine|Days 1-5: Clofarabine 30 mg/m^2 for 0-30 years of age or 20 mg/m^2 for > 30 years of age intravenously (IV) over 2 hours
16163281|NCT01677949|Drug|Etoposide|Days 1-5: Etoposide 100mg/m^2 IV over 2 hours
16163282|NCT01677949|Drug|Cyclophosphamide|Days 1-5: Cyclophosphamide 300 mg/m^2 as a 30-60 minute infusion
16163283|NCT01677949|Biological|allogeneic hematopoietic cell transplantation|Between Days 28 and 42: infused independent of this study
16163284|NCT01677936|Other|Raisins|1 oz, 90 calorie packages of raisins will be administered to subjects in the raisin treatment arm
16163285|NCT01677936|Other|Snacks|100 calorie snack packs will be administered to the subjects in the snack group
16163286|NCT01677923|Drug|Metformin|Metformin 500 mg BID for 12 months
16163287|NCT01677910|Drug|Telotristat etiprate|Telotristat etiprate tablets.
16163288|NCT01677910|Drug|Placebo-matching telotristat etiprate|Placebo-matching telotristat etiprate tablets.
16163289|NCT01677897|Drug|Metformin|Adding Metformin to Abiraterone in case of PSA-Progression
16163290|NCT01677884|Drug|Bevacizumab|Every 3 weeks : 7.5 mg/kg intra arterial in 2 hours at D1
16163291|NCT01677884|Drug|Capecitabine|Every 3 weeks: 2000 mg/m²/d in 2 times/d from D1 to D4
16163292|NCT01677884|Drug|Irinotecan|Every 3 weeks: 200mg/m² in 30mn IV at D1 (if oxaliplatin in first line) or oxaliplatin 130mg/m² in 2h IV at D1 (if irinotecan in first line)
16163293|NCT01677871|Drug|2HRZE/4HR|Isoniazid + Rifampicin+Pyrazinamide+Ethambutol for initial 2 months floolowed by Isoniazid + Rifampicin for next 4 months
16163294|NCT01677871|Drug|2HRLE/4HR|Isoniazid + Rifampicin+ Levofloxacin+Ethambutol for initial 2 months followed by Isonizid + Rifampicin for next 4 months
16163295|NCT01677871|Drug|9HLE|Isoniazid+ Levofloxacin+ Ethambutol for 9 months
16163296|NCT01677871|Drug|9RLE|Rifampicin + Levofloxacin+ Ethambutol for 9 months
16163297|NCT01677858|Drug|Carfilzomib|Carfilzomib was administered as a 30-minute IV infusion on days 1, 8, and 15 of each 28-day treatment cycle.
16163298|NCT01677858|Drug|Dexamethasone|Dexamethasone was administered at a dose of 40 mg IV or orally (PO) on days 1, 8, 15, and 22 for the first 8 cycles; starting with cycle 9 dexamethasone was administered on days 1, 8, and 15.
16163299|NCT01677845|Radiation|Radiation|"Dose Level 1: 54 Gy; 3 Gy per fraction; 3 days per week x 6 weeks for a total of 18 fractions;
~Dose Level 2: 55.8 Gy; 3.1 Gy per fraction; 3 days per week x 6 weeks for a total of 18 fractions;
~Dose Level 3: 57.6 Gy; 3.2 Gy per fraction; 3 days per week x 6 weeks for a total of 18 fractions."
16163300|NCT01677806|Procedure|Percutaneous vertebroplasty|Percutaneous vertebroplasty Placement of PMMA into vertebral compression fracture
16163301|NCT01677806|Other|Conservative therapy|Conservative therapy mainly consists of optimal pain medication. Pain management is titrated according to patients' needs, including analgesia, bed rest, and physical support (bracing).
16163302|NCT01677780|Drug|RO5045337|Participants will receive RO5045337 orally in doses ranging from 20 milligram per square meter (mg/m^2) to 1800 mg/m^2 daily, and up to 1500 mg dose twice daily on a variety of schedules including daily for up to 20 days and weekly dosing for 3 weeks in 28 day cycles until disease progression or unacceptable toxicity with maximum treatment duration of 24 months.
16163303|NCT01677754|Drug|RO4602522|Participants will receive RO4602522 orally once daily for 12 months.
16163304|NCT01677754|Drug|Placebo|Participants will receive placebo for RO4602522 orally once daily for 12 months.
16163305|NCT01677754|Drug|Donepezil|Stable dose as background medication
16163306|NCT01677754|Drug|Memantine|Stable dose as background medication in combination with AChEIs
16163307|NCT01677754|Drug|Rivastigmine|Stable dose as background medication
16163308|NCT01677754|Drug|Galantamine|Stable dose as background medication
16163309|NCT01677741|Drug|Dabrafenib|Dabrafenib is available as 50 mg or 75 mg capsules and as oral suspension (10 mg/mL for subjects unable to swallow capsules). Dabrafenib (either formulation) will be administered orally as a single dose on Day 1 and twice daily from Day 2, based on weight at the appropriate study dose level.
16163310|NCT01677715|Dietary Supplement|"Yili Mei Yi Tian active lactobacillus drink"|"100ml of Yili Mei Yi Tian active lactobacillus drink to be taken once per day at 10am daily during the 84-days intervention"
16163311|NCT01677715|Dietary Supplement|recombined milk drink contains no lactobacillus|100ml of recombined milk drink contains no lactobacillus to be taken once per day at 10am daily during the 84-days intervention
16163312|NCT01677702|Dietary Supplement|Yili Lactoferrin ShuHua Milk (Lactoferrin 5mg/100ml)|Total 250mL milk (with lactoferrin 5mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.
16163313|NCT01677702|Dietary Supplement|Yili Lactoferrin ShuHua Milk (Lactoferrin 10mg/100ml)|Total 250mL milk (with lactoferrin 10mg/100ml) will be taken once per day at 10am daily during the 84 days intervention.
16163314|NCT01677702|Dietary Supplement|Recombined low protein milk|Total 250ml of placebo milk will be taken once a day at 10am daily during the 84 day intervention.
16163315|NCT01677689|Drug|Apomivir®|Study Group: Apomivir® 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal.
16163316|NCT01677689|Drug|Placebo|Control Group: Placebo 1 capsule twice daily. All subjects will be treated for 5 days, and all drugs should be taken orally after meal.
16163317|NCT01677676|Biological|FP-01.1|IM injection
16163318|NCT01677676|Biological|FP-01.1-Adjuvant|IM injection
16163319|NCT01677650|Drug|Methadone|Methadone IV Pre-Induction of Anesthesia 0.15 to 0.5 mg/kg
16163320|NCT01677624|Device|E7040|E7040 of optimal particle size (-300 um, 300-500 um, or 500-700 um to fit in a target vessel, target lesion, or embolized area) as transcatheter study device will be administered .
16163321|NCT01677611|Drug|Trans-resveratrol extract from Polygonum Cuspidatum|Starting dose of 500 mg daily of either resveratrol to be administered on Day 1 and increased by 500 mg per day every 3 days to a maximum dose of 3 g per day in three divided doses if there was no hypoglycemia.
16163322|NCT01677611|Drug|Placebo|
16163323|NCT01677598|Drug|No intervention|No intervention will be administered during study. This will be an observational study in patients using ustekinumab as label-recommended or other/missed dose interval in Asia-Pacific countries
16163324|NCT01677572|Drug|Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb)|Participants will receive an infusion of Aducanumab on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, and 365 (±2 days) at the study clinic and assigned does levels. The infusion will be administered for approximately 1 hour. The study is conducted with a staggered, parallel group design, with the first 3 treatment arms conducted in parallel, 2 further treatment arms subsequently beginning in parallel and the 2 last treatment arms subsequently beginning in parallel. Qualifying participants can enter the long-term extension period at doses described in the treatment arms for up to an additional 112 doses.
16163325|NCT01677572|Drug|Placebo|Placebo to mimic the low dose, mid-dose and high-dose treatment arms of the experimental intervention; administered by intravenous (IV) infusion on Days 1, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, 337, and 365 (±2 days) at the study clinic. Qualifying participants can enter the long-term extension period at doses described in the treatment arms for up to an additional 112 doses.
16163326|NCT01677559|Drug|MLN8237|
16163327|NCT01677559|Drug|nab-Paclitaxel|
16163328|NCT01677546|Device|CSII+BC+CL|Insulin pump bolus calculator wirelessly communicated with blood glucose meter (Contour Link)
16163329|NCT01677546|Device|CSII+BC|Insulin pump bolus calculator without wireless communication with blood glucose meter (Contour Link)
16163330|NCT01677533|Other|Data|The microsystem teams of providers, nurses, and clerks will receive monthly reports of their performance measures, which will include process and outcome data for smoking cessation and blood pressure control for veterans in their panel. The reports will provide lists of individual patients in the panel with unmet goals on VA performance measures. They will receive written informational material describing principles and practices of panel management and evidence-based guidelines for hypertension management and smoking cessation.
16163331|NCT01677533|Other|Panel Management Support|PMAs will meet regularly with the members of the microsystem team for one hour/week. The team will be asked to review progress on the health status of their patient panel and to plan strategies for improving their outcomes that the PMA will then implement. A PMA toolkit of panel management strategies will be established that will include guidelines for using VA databases to identify care gaps and reaching out to panel patients via phone and mail to intervene (e.g. reconnect patients to care with appointments, assess and enhance medication adherence, connect patients with VA services, motivational interviewing, and communication with the team about patient issues.
16163332|NCT01677533|Other|Education|The educational intervention will be administered throughout the duration of the study. Our initial educational focus will be on content (concepts of population health and panel management) and process (practice change methodology). Subsequent education will be process oriented, reviewing the changing system of care and discussing its functioning. Education will cover panel management strategies, microsystem theory and skills, and specific strategies regarding the management of hypertension and smoking cessation. It will include monthly seminars, reading materials, web-based modules, and skill building workshops, and PMA-conducted monthly academic detailing using panel data and feedback. After the first three months, academic detailing will only be implemented on an as-needed basis.
16163333|NCT01677507|Drug|Variation in eye pressure response to timolol and latanoprost treatment|Arm 1 is to test for variation in eye pressure response to timolol. Arm 2 is to test for variation in eye pressure response to latanoprost.
16163334|NCT01677468|Procedure|Intermediate embolization|TACE with substasis using gelfoam
16163335|NCT01677468|Procedure|Complete embolization|TACE with complete embolization using gelfoam
16163336|NCT01677455|Drug|ganetespib|Ganetespib 150 mg/m2 will be administered intravenously, twice weekly, for three consecutive weeks of each 4 week cycle.
16163337|NCT01677442|Procedure|no-intubated thoracic epidural anesthesia|VATS under no-intubated thoracic epidural anesthesia
16163338|NCT01677442|Procedure|double-lumen endotracheal intubated anesthesia|VATS under double-lumen endotracheal intubated anesthesia
16163339|NCT01677429|Device|VR movie + balance challenge|Computer Assisted Rehabilitation Environment Integrated Reality System used for the challenge of balance control
16163340|NCT01677429|Device|still pictures from VR|Monitoring only still pictures from the VR scene in a loop, no balance challenge
16163341|NCT01677429|Behavioral|Cognitive Behavioral Therapy|For the treatment of panic disorder
16163342|NCT01677403|Drug|Tobramycin|Nebulised 80mg twice daily
16163343|NCT01677403|Drug|Saline|Nebulised 5mls 0.9% Saline twice daily
16163344|NCT01677390|Drug|SGN-75|1-2 mg/kg IV every 21 days
16163345|NCT01677390|Drug|everolimus|10 mg PO daily
16163391|NCT01676987|Drug|Fixed combination of budesonide and formoterol|Delivered dry powder inhaler for 12 weeks.
16163346|NCT01677377|Drug|Risperidone|Oral risperidone was supplied as 2, 3, or 4 mg tablets in blister packs or bottles and taken daily only during the oral dosing periods of the study, days -14 through -8 (if applicable), days -7 through -1, and days 85 through 87.
16163347|NCT01677377|Drug|RBP-7000|RBP-7000 60 mg, 90 mg, and 120 mg were a mixture of the ATRIGEL® Delivery System and 60 mg, 90 mg, or 120 mg risperidone, respectively. Treatment was delivered as subcutaneous injections on study days 1, 29 and 57.
16163348|NCT01677364|Drug|Oxytocin|Arm - Induction of labour
16163349|NCT01677351|Drug|Clonidine|4 mcg.kg-1, 20 minutes before cataract surgery
16163350|NCT01677351|Drug|placebo|
16163351|NCT01677338|Drug|13C-uracil|PO, the Semi-solid Test Meal containing 100 mg of 13C-uracil . Perform the Breath Test.
16163352|NCT01677338|Drug|99mTc sulfur colloid|PO, the Solid Test Meal containing 500 uCi 99mTc sulfur colloid. Perform the Scintigraphy.
16163353|NCT01677325|Drug|Chinese herb (YiQiSanJu)|Chinese herb formula:Huangqi,huanglian,yinchen,ect
16163354|NCT01677312|Procedure|Pancreatic Biopsy|A FNA needle will be used to biopsy the pancreatic mass. The rates of diagnostic accuracy (%) will be assessed. Diagnostic accuracy is defined as the proportion of patients in whom a definitive diagnosis can be obtained within a predetermined number of FNA passes.
16163355|NCT01677312|Procedure|Histological Samples|The proportion of patients (%) in whom a histological tissue can be obtained when performing a biopsy of the pancreas using a specific needle will be assessed.
16163356|NCT01677299|Drug|EFB0027 (metformin delayed release)|Comparison of enteric-coating to assess effect on PK
16163357|NCT01677299|Drug|EFB0026 (metformin immediate-release)|Active comparator
16163358|NCT01677286|Drug|Doxycycline 100 mg po bid x 12 months|100mg by mouth twice daily for 1 year.
16163359|NCT01677273|Dietary Supplement|Hydrolyzed casein|30 g protein/supplement, 4 supplements/visit
16163360|NCT01677273|Dietary Supplement|Intact casein|30 g protein/supplement, 4 supplements/visit
16163361|NCT01677273|Dietary Supplement|Intact whey protein|30 g protein/supplement, 4 supplements/visit
16163362|NCT01677260|Drug|500 mg metformin hydrochloride extended release caplet (test drug)|In each of the two study periods (separated by a washout of one week) a single and multiple dose of test or reference product was administered.
16163363|NCT01677260|Drug|500 mg metformin hydrochloride prolonged release tablet (reference drug)|In each of the two study periods (separated by a washout of one week) a single and multiple dose of test or reference product was administered.
16163364|NCT01677247|Drug|Group I (Test) : Glimepiride 4 mg tablet of PT Dexa Medica|In each of the two study periods (separated by a washout of one week) a single dose of test or reference product was administered.
16163365|NCT01677247|Drug|Group II (Reference) : glimepiride (Amaryl) 4 mg tablet of PT Sanofi Aventis|In each of the two study periods (separated by a washout of one week) a single dose of test or reference product was administered.
16163366|NCT01677221|Device|Acleara Acne Treatment System|
16163367|NCT01677208|Drug|Danhong injection|A kind of injection made from two kind of Chinese herbs: Salvia miltiorrhiza and Safflower. 40ml Danhong injection added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion
16163368|NCT01677208|Procedure|Standard medical care|Standard medical care is in accordance with China Guideline for the diagnosis and treatment of acute ischemic stroke (2010), including medical care for vital signs, control of temperature, blood pressure and glucose, improving cerebral blood circulation, antiplatelet treatment and nutritional supportive care.
16163369|NCT01677208|Drug|placebo|0.9% saline added into 250ml 0.9% saline by an independent research nurse, sealed with brown bag in order to make the investigators and patients blinded, using brown infusion tube for infusion.
16163370|NCT01677195|Drug|ACCS100|ACCS100 is not absorbed. The dose is estimated based on the volume of the gastrointestinal tract. We estimate that the average human intestinal tract has a volume of approximately 4 liters. In the high dose group, the effective concentration in the gut is 0.75 milligrams per milliliter. In the low dose, the effective concentration in the gut is 0.375 milligrams per milliliter. The test article is made by filling gelatin capsules with 500 milligrams of ACCS100. There are no excipients used in the manufacturing process of the test article.
16163371|NCT01677195|Drug|Placebo|Placebo is calcium carbonate, USP. This calcium mineral does not absorb mycotoxins, specifically aflatoxin and fumonisin. This mineral has approximately the same physical appearance as active test article.
16163372|NCT01677182|Drug|Ramelteon|Ramelteon tablets for sublingual administration
16163373|NCT01677182|Drug|Placebo|Ramelteon placebo-matching tablets for sublingual administration
16163374|NCT01677169|Dietary Supplement|Noni juice|Ingestion of noni juice, a source of iridoids, daily for 30 days.
16163375|NCT01677169|Dietary Supplement|Placebo|
16163376|NCT01677156|Diagnostic Test|CORUS CAD (ASGES)|Age/Sex/Gene Expression Score - ASGES
16163377|NCT01677143|Drug|Bupivacaine 5mg/ml|5 ml in trocar area
16163378|NCT01677104|Drug|GLP-1|GLP-1 and its analogues will be compared with placebo with and without prior DPP-IV inhibition
16163379|NCT01677104|Drug|Placebo|
16163380|NCT01677091|Other|Cervical vibration|Vibration of neck muscles during 10 minutes
16163381|NCT01677091|Other|Prism adaptation|Prism adaptation during 10 minutes
16163382|NCT01677091|Other|Conventional rehabilitation|conventional rehabilitation
16163383|NCT01677078|Device|Neuronavigation system|Neuronavigation
16163384|NCT01677078|Device|Standard localisation method|Manual localisation of the DLPFC using the standard localisation method (i.e. the '5-cm method')
16163385|NCT01677065|Drug|Oxycodone controlled-release test formulation|single dose administration of test formulation under fasted conditions
16163386|NCT01677065|Drug|Immediate-release reference drug|single dose administration of reference drug under fasted conditions
16163387|NCT01677039|Drug|Test formulation administered with water|single dose of 20 mg of test formulation with 240 mL of water
16163388|NCT01677039|Drug|Test formulation administered with 20% ethanol|single dose of 20 mg of test formulation with 240 mL of 20% ethanol in water
16163389|NCT01677039|Drug|Test formulation administered with 40% ethanol|single dose of 20 mg of test formulation with 240 mL of 40% ethanol
16163390|NCT01677013|Other|BMMCT|Bone marrow mononuclear cell transplantation via selective catheterization
16163396|NCT01676948|Drug|Canakinumab|"Patients rolling over into this study from CACZ885G2301E1 (Cohort 1) will continue on their established canakinumab dose of either 4 mg/kg SC given every 4 weeks or 2mg/kg SC given every 4 weeks, until eligible for dose reduction.
~Canakinumab-naïve patients"
16163397|NCT01676948|Drug|Canakinumab|Patients rolling over into this study from CACZ885G2301E1(Cohort 2) will receive a standard canakinumab dose of 4mg/kg SC given every 4 weeks, until eligible for dose reduction
16163398|NCT01676935|Drug|ABT-126|See arm description
16163399|NCT01676909|Behavioral|Living Well|This study will involve a clinical trial of Living Well (LW), a 12-session, peer co-led, group intervention designed to help veterans with co-occurring Serious Mental Illnesses and Chronic Medical Conditions learn techniques for better health management and ways to live a healthier lifestyle. Key topics that will be discussed are medication side effects, how symptoms of mental illness may affect veterans' ability to manage their medical conditions, effects of substance use on medical and mental health functioning, learning ways to eat healthier and exercise, and how to communicate more effectively with care providers. There will be 3 booster sessions after the 12 sessions, once a month for 3 months.
16163400|NCT01676909|Behavioral|Medical Illness Education & Support Group|The comparison condition will be a general Medical Illness Education and Support (MIES) group that will discuss common challenges experienced by those living with a wide range of chronic illnesses and behavioral and lifestyle management techniques that may help veterans to better handle chronic medical conditions that also meets for 12 weeks.
16163401|NCT01676896|Behavioral|Asthma in-school class|
16163402|NCT01676896|Behavioral|Asthma Day Camp|
16163403|NCT01676896|Behavioral|Health Promotion in-school class|
16163404|NCT01676883|Device|Bioelectric impedance|removal of calluses and corns by pedicure
16163405|NCT01676883|Device|Air displacement plethysmography|
16163406|NCT01676870|Behavioral|1x4 aerobic interval training|"endurance training as walking/running uphill 3 times/week for 16 weeks (2 supervised sessions (treadmill) and 1 at home each week) at 90% of Hfmax. Warm-up 10 min at 70% of maximal heart frequency (Hfmax), 5min cool-down."
16163407|NCT01676870|Behavioral|4x4 aerobic interval training|"endurance training as walking/running uphill 3 times/week for 16 weeks (2 supervised sessions (treadmill) and 1 at home each week) at 90% of Hfmax. Warm-up 10 min at 70% of maximal heart frequency (Hfmax), 3 min active pause between each interval, 5min cool-down."
16163408|NCT01676870|Behavioral|traditional moderate training|moderate intensity treadmill training (50-70% of HRmax) for a minimum of 30min, 5 times a week for 16 weeks (2 supervised sessions and 3 or more home).
16163409|NCT01676844|Drug|Oral thin film therapy (Potassium acid phosphate oral thin films)|"Orally dissolving thin film. White, square oral thin film. 15 mm x 15 mm surface area. 1-2 mm film thickness. No markings.
~Place a single OTF on the tongue, inside cheek or palate and allow to dissolve."
16163410|NCT01676844|Drug|Standard therapy (Potassium acid phosphate oral solution)|Each millilitre contains approximately 136mg Monobasic Potassium Phosphate Ph.Eur. (KH2PO4) equivalent to 1mmol Potassium (39mg) and 1mmol Phosphate (31mg Phosphorus). Manufacturer: Specials Products Ltd., Surrey, UK.
16163411|NCT01676831|Drug|Topical resiquimod 0.06%|topical resiquimod 0.06% dosing frequency begins at 3 times per week and evaluated every two weeks. Will be applied for a total of 8 weeks followed by 4 weeks rest and then followed by another 8 weeks of application with another 4 weeks rest.
16163412|NCT01676831|Drug|topical resiquimod 0.03%|topical resiquimod 0.03% applied initially 5 times weekly for 8 weeks with adjustments up or down based upon tolerability followed by 4 weeks rest followed by another 8 weeks of treatment followed by another 4 week rest period.
16163413|NCT01676818|Drug|eribulin mesylate|Given IV
16163414|NCT01676792|Drug|SR-T100 gel with 2.3% of SM in Solanum undatum plant extract|Self administered topical SR-T100 gel on lesion(s) including its peripheral normal skin approximately 1cm around the lesion with the amount of 0.02 g/cm squared with occlusive dressing once daily. Patients who is unable to tolerate with occlusive dressing is instructed 3 times daily in the morning, afternoon & before bed time. Medication should be reapply after bathing or cleaning.
16163415|NCT01676779|Biological|Dendritic cell therapy|Dendritic cell therapy IV and ID
16163416|NCT01676753|Drug|Dinaciclib|"Given IV.
~Dose Level = DL
~DL1-12 mg/m2
~DL2-18 mg/m2
~DL3-25 mg/m2
~DL4-33 mg/m2
~DL5-50 mg/m2"
16163417|NCT01676753|Drug|Pembrolizumab|Given 200mg IV.
16163418|NCT01676740|Drug|Iron Supplement,|Pills to be swallowed
16163419|NCT01676740|Drug|Placebo|Daily administration of active drug or placebo
16163420|NCT01676727|Device|CoreValve aortic valve|Implantation of CoreValve aortic valve via direct aortic approach
16163421|NCT01676714|Drug|Dovitinib|
16163422|NCT01676701|Drug|Tabalumab Auto-Injector|Administered SC by auto-injector
16163423|NCT01676701|Drug|Tabalumab Prefilled Syringe|Administered SC by prefilled syringe
16163424|NCT01676675|Biological|7.5μg /0.5ml|whole virus inactivated influenza H5N1 vaccine of 7.5μg /0.5ml, two doses, 21 days interval
16163425|NCT01676675|Biological|15.0μg /0.5ml|whole virus inactivated influenza H5N1 vaccine of 15.0μg /0.5ml, two doses, 21 days interval
16163426|NCT01676675|Biological|30.0μg /0.5ml|whole virus inactivated influenza H5N1 vaccine of 30.0μg /0.5ml, two doses, 21 days interval
16163427|NCT01676675|Biological|0/0.5ml placebo|0/0.5ml placebo, two doses, 21 days interval
16163428|NCT01676662|Device|Solace Bladder Control System|Subjects may undergo treatment every 12 months until study completion.
16163429|NCT01676662|Device|Solace Sham Treatment|Sham procedure that resembles treatment with the Solace Bladder Control System
16163430|NCT01676649|Biological|Ipilimumab|3 mg/kg
16163431|NCT01676649|Drug|Carboplatin|AUC = 6
16163432|NCT01676649|Drug|Paclitaxel|175 mg/m2
16163433|NCT01676636|Drug|Traditional Tablet|The traditional tablets will be swallowed with liquid. Each tablet will contain 500 mg of calcium (as calcium carbonate), thus participants will be asked to take 3 per day.. Participants will be asked to take the tablets with a liquid of their choosing with a meal. Traditional tablets will function as a control in this study, as they represent what is widely available on the market in Bangladesh.
16163434|NCT01676636|Drug|Chewable tablets|Chewable tablets are chewed in the absence of additional water. Each chewable tablet will contain 300 mg of calcium (as calcium carbonate), thus participants will be asked to take 5 per day. Participants will be asked to consume the chewable tablets with a meal.
16256201|NCT00964327|Drug|TMC114|
16163435|NCT01676636|Drug|Unflavoured Powder|The unflavoured powder with suspension agent will be tasteless and consumed by either adding it to a semi-solid food or drink of one's choosing. Appropriate foods for mixing with the powder will be at the discretion of the participants. This vehicle was selected on the basis that it would be easy to swallow, given the nausea associated with pregnancy. A similar product is Sprinkles, a multiple micronutrient powder developed at SickKids by Dr. Zlotkin.
16163436|NCT01676636|Drug|Flavoured Powder|The flavoured powder with suspension agent will be consumed by adding it to clean water with a meal. This vehicle was also selected on the basis that it would be easy to swallow, given the nausea associated with pregnancy. Similar products include oral rehydration salts or artificial juice flavour crystals.
16163437|NCT01676623|Behavioral|Standard government health services|This intervention will be basic preventive and curative health services provided by the commune health centers. This includes antenatal care, postnatal care and basic nutrition related counseling.
16163438|NCT01676623|Behavioral|Alive & Thrive IYCF franchise services|This intervention includes intensive behavioral counseling to improve infant and young child feeding. A package of 15 counseling contacts that are quality assured and branded will be offered to families of infants and young children. Services might also include user fees.
16163439|NCT01676623|Behavioral|Mass media campaign|Alive & Thrive is implementing a nationwide mass media campaign in 2011, 2012 and 2013, with a focus on improving breastfeeding practices. The mass media intervention includes TV and radio spots as well as an internet site and a telephone hotline.
16163440|NCT01676597|Drug|pentoxifylline and rifaximin|Tab Rifaximin 400 mg thrice daily + Pentoxifylline 400 mg thrice daily for 12 weeks
16163441|NCT01676597|Drug|Pentoxifylline and placebo|Tab Pentoxifylline 400 mg thrice daily + Placebo thrice daily for 12 weeks
16163442|NCT01676584|Drug|RO6811135|single ascending doses sc
16163443|NCT01676584|Drug|placebo|single doses sc
16163444|NCT01676571|Drug|Lu AA21004|10 mg immediate-release (IR), one single dose, orally
16163445|NCT01676558|Drug|131I-rituximab|
16163446|NCT01676532|Other|Students attending SBHC|School based health clinic. This is a cohort study as such there is only one group of children who used the SBHC
16163447|NCT01676519|Procedure|PCI|percutaneous coronary intervention
16163448|NCT01676506|Drug|Ranibizumab|Intravitreal injections of 0.5mg/0.05 mL dosage, injected at months 0, 1, and 2.
16163449|NCT01676506|Procedure|Ranibizumab Injection|
16163450|NCT01676493|Drug|Codeine|
16163451|NCT01676480|Behavioral|Endurance training|12 weeks of endurance training 3 times per week
16163452|NCT01676441|Drug|cellgram-spine|Mesenchymal stem cells transplantation
16163453|NCT01676428|Radiation|Radiotherapy|"The investigational treatment will be prescribed as a 2-tiered dose scheduled dependant on target size.
~For lesions <5cm, a single fraction of 26Gy will be prescribed. For lesions ≥5cm a fractionated course of 14Gy by 3 fractions will be prescribed, delivered at least 48 hours apart."
16163454|NCT01676415|Drug|Prednisone|"Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily
~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead
~Antihistamines if an appropriate history of atopy is obtained
~Systemic prednisone: Starting dose of 40mg for five days followed by a taper decreasing by 10mg every 5 days
~Following completion of the oral corticosteroid: Course of topical mometasone until the end of the study"
16163455|NCT01676415|Drug|Topical mometasone|"Three-week course of a broad-spectrum antibiotic Amoxicillin/Clavulanate at a daily dosage of 875mg twice daily
~If the subject is allergic to Penicillin and its derivatives or has had an adverse reaction to Amoxicillin/Clavulanate, a three-week course of clarithromycin instead
~Antihistamines if an appropriate history of atopy is obtained
~Standing course of topical mometasone at the standard dose of 2 sprays to each nostril once daily and will remain on the topical mometasone until the end of the study."
16163456|NCT01676402|Biological|Seasonal Influenza DNA vaccine|VRC-FLUDNA063-00-VP is composed of 3 closed-circular DNA plasmids that encode for the hemagglutinin (HA) from the following 3 strains: A/California/04/2009 (H1); A/Victoria/361/2011 (H3), and B/Wisconsin/2010. DNA vaccine vials will be supplied at 4 mg/mL in single use vials. The 4 mg dosage is administered as a 1 mL volume.
16163457|NCT01676402|Biological|TIV|2012/13, 2013/14 Seasonal Influenza Trivalent Inactivated Vaccine (TIV)
16163458|NCT01676389|Other|Sham OMM|Sham Osteopathic Manual Medicine (OMM).
16163459|NCT01676389|Other|Osteopathic Manual Medicine (Body Therapy)|OMM techniques include the following - paraspinal soft tissue myofascial release, rib raising, cervical spine soft tissue myofascial release, suboccipital inhibition, thoracic balanced ligamentous tension technique, thoracic lymphatic pump and pedal lymphatic pump.
16163460|NCT01676376|Device|eSVS Mesh treated saphenous vein graft|During coronary artery bypass graft surgery, one SVG will be randomized to be treated with eSVS Mesh and implanted in the right or left coronary system.
16163461|NCT01676376|Other|Control saphenous vein graft|During coronary artery bypass graft surgery, one SVG will be randomized to be the control (no eSVS Mesh) and implanted in the right or left coronary system.
16163462|NCT01676363|Drug|Diflunisal|Open-label diflunisal 500 mg twice daily for 4 weeks
16163463|NCT01676350|Procedure|IO access using EZ-IO®|IO line placed using an FDA-approved device called an EZ-IO®.
16163464|NCT01676337|Other|Text message appointment reminder|Patients randomized to the intervention arm will receive text message appointment reminders including date, time, and location seven, three and one day prior to their scheduled clinic appointments. All appointment reminders will then be delivered automatically.
16163465|NCT01676311|Drug|Huperzine A|Huperzine A will be administered for 12 weeks as outlined in the Arm Description
16163466|NCT01676311|Drug|Placebo|Placebo Arm (blinded randomization) for Huperzine A Intervention
16163467|NCT01676298|Device|Spartan FRX CYP2C19 Test System|
16163468|NCT01676285|Drug|Metoprolol succinate|
16163469|NCT01676285|Drug|placebo|
16163470|NCT01676259|Drug|siG12D-LODER|The implantation of siG12D-LODERs is selected to meet current gastroenterology endoscopic ultrasound (EUS) biopsy procedures, proved to be highly effective and safe.
16163471|NCT01676259|Drug|Gemcitabine+nab-Paclitaxel|Gemcitabine+nab-Paclitaxel
16163472|NCT01676259|Drug|Folfirinox|Folfirinox or modified Folfirinox
16163553|NCT01675648|Drug|Placebo for Lofexidine|
16163473|NCT01676246|Drug|100 mg flupirtine intravenous|Administration of 100 mg flupirtine intravenous (3 mg solution intravenously, 1 vial Kadadolon® inject)
16163474|NCT01676246|Drug|100 mg flupirtine per os|Administration of 100 mg flupirtine per os (1 capsule Kadadolon®)
16163475|NCT01676246|Drug|400 mg flupirtine per os|Administration of 400 mg flupirtine (1 Kadadolon® S long retard tablet)
16163476|NCT01676246|Procedure|induce delayed onset of muscle soreness (DOMS)|"The DOMS exercise protocol consists of two sets of 50 concentric/eccentric contractions of the calf muscles of one leg with a rest of 5 min in-between. The exercise is performed 22-26 h prior to medication. For pain measurements, muscle pain is stimulated by standing on tiptoes of one leg for 30 s, which requires a constriction of the affected calf muscles. The other leg is lifted and the subjects are allowed to hold on to a table to keep their balance. The pain intensity during this stimulation is then rated by means of a 10 cm visual analogue scale (VAS). The VAS is extended from no pain to intolerable pain with a precision of 1 mm. The stimulation is repeated with the other leg. The sequence of the legs is chosen randomly."
16163477|NCT01676246|Procedure|electric pain measurement|"The method has been described to be sensitive to quantify analgesic opioid effects. Painful 5 Hz sine waves electrical stimuli (increase of intensity 0.2 mA/s, from 0 to 20 mA), which predominantly activate C-fibres, will be applied via two gold electrodes placed on the medial and lateral side of the distal phalangeal joint (middle finger of the left hand as default-testing site).
~During testing, subjects keep a button continuously pressed until they find the pain intolerably and interrupt the current by releasing the button. The electrical current at which this occurred is defined as pain tolerance, the target parameter of this pain model. Each value of pain tolerance is the median of five subsequent measurements obtained at an interval of 1 min."
16163478|NCT01676233|Drug|insulin glargine (HOE901)|Pharmaceutical form: solution Route of administration: subcutaneous
16163479|NCT01676233|Drug|insulin glargine- new formulation (HOE901)|Pharmaceutical form: solution Route of administration: subcutaneous
16163480|NCT01676220|Drug|HOE901-U300 (new formulation of insulin glargine)|HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily (evening) for 12 months on top of non-insulin antihyperglycemic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter [mg/dL]).
16163481|NCT01676220|Drug|Lantus (insulin glargine)|Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months on top of non-insulin antihyperglycemic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).
16163482|NCT01676207|Procedure|Coronary Angiography with collateral flow measurements|"Diagnostic coronary angiography and LV angiography
~Administration of 5'000 units of heparin i.v. and 2 puffs of oral isosorbide-dinitrate
~Right and left IMA CFI during a 1-minute ostial vessel occlusion
~Selection of the coronary artery for CFI according to stenotic lesion chosen for PCI or according to ease of access by the pressure sensor wire. Placement of a non-sensor wire in the left IMA. Two coronary CFI measurements (1-minute occlusion): the first with, the second without distal IMA balloon occlusion. Placement of a non-sensor wire in the right IMA. Two coronary CFI measurements: the first with, the second without distal IMA balloon occlusion.
~IMA angiography (left and right) during distal IMA and coronary occlusion."
16163483|NCT01676207|Procedure|Coronary Angiography with collateral flow measurements|"Diagnostic coronary angiography and LV angiography
~Administration of 5'000 units of heparin i.v. and 2 puffs of oral isosorbide-dinitrate
~Right and left IMA CFI during a 1-minute ostial vessel occlusion
~Selection of the coronary artery for CFI according to stenotic lesion chosen for PCI or according to ease of access by the pressure sensor wire. Placement of a non-sensor wire in the left IMA. Two coronary CFI measurements (1-minute occlusion): the first with, the second without distal IMA balloon occlusion. Placement of a non-sensor wire in the right IMA. Two coronary CFI measurements: the first with, the second without distal IMA balloon occlusion.
~IMA angiography (left and right) during distal IMA and coronary occlusion."
16163484|NCT01676194|Other|Intra-arterial administration of DC BeadsR|
16163485|NCT01676181|Procedure|Adenotonsillectomy|Total removal of tonsils and adenoid tissue with cold-steel
16163486|NCT01676181|Procedure|Adenotonsillotomy|Partial removal of tonsils with coblation and total removal of adenoids with cold steel
16163487|NCT01676129|Procedure|Nocipoint Therapy|
16163488|NCT01676129|Procedure|Physical Therapy|
16163489|NCT01676116|Drug|insulin degludec/liraglutide|Injected subcutaneously (under the skin) once daily. Dose individually adjusted. Subjects will continue their pre-trial OAD treatment without changing the frequency or dose throughout the trial.
16163490|NCT01676116|Drug|liraglutide|Subjects will continue on their pre-trial treatment of liraglutide (Victoza®) (GLP-1 receptor agonist) + OAD without changing the frequency or dose throughout the trial.
16163491|NCT01676116|Drug|exenatide|Subjects will continue on their pre-trial treatment of exenatide (Byetta®) (GLP-1 receptor agonist) + OAD without changing the frequency or dose throughout the trial.
16163492|NCT01676103|Dietary Supplement|Tyrosine|Tyrosine supplementation (500 mg 2 x daily) for 7 days
16163493|NCT01676103|Other|Placebo Comparator:Sugar Pill|Placebo sugar pills (2x daily
16163494|NCT01676064|Drug|ringer lactate solution|
16163495|NCT01676064|Other|restrictive fluid regime|
16163496|NCT01676051|Other|Skin culture|Culture swab used to culture skin adjacent to incision
16163497|NCT01676038|Procedure|Pinless-Navigated Total Knee Arthroplasty|Brainlab VectorVision Knee 2.5 Navigation System
16163498|NCT01676038|Procedure|Conventional Total Knee Arthroplasty|Conventional technique.
16163499|NCT01676025|Procedure|PRA|
16163500|NCT01676025|Procedure|LA|
16163501|NCT01675999|Other|Perioperative simplified FOLFOX-4 chemotherapy|Preoperative chemotherapy
16163502|NCT01675999|Other|Perioperative FOLFOX4+Cetuximab chemotherapy|Preoperative chemotherapy
16163503|NCT01675999|Other|Surgery followed by FOLFOX4 chemotherapy|Preoperative chemotherapy
16163504|NCT01675986|Drug|hydroxyzine|75 mg
16163505|NCT01675986|Drug|Pregabalin|150 mg
16163506|NCT01675986|Drug|Lactose|4 g
16163507|NCT01675973|Drug|RANEXA|500mg BID up to 1000mg BID
16163550|NCT01675661|Drug|Placebo|Study participants randomly assigned to the placebo arm will receive a matched placebo twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.
16163508|NCT01675960|Drug|Gabapentin|The active drug is in a flavored glycerin based solution. The drug will be given orally or through a gastrointestinal tube. Titration up to a stable dose will take 22 days. The total stable dose is 40mg/kg/day. Once 7 days on this dose are finished, children will take 6 days to reduce their dose and begin their 3 day washout period.
16163509|NCT01675960|Drug|placebo|The placebo is a glycerin-based clear solution that is flavored similarly to the commercial product. The placebo will be given orally or through a gastrointestinal tube.
16163510|NCT01675947|Drug|Sirolimus|Immunosuppressive agent. Blocks the T-lymphocyte activation and smooth muscle and endothelial cell proliferation that occurs in response to antigenic and cytokine (interleukin IL-2, IL-4 and IL-15) stimulation through either Ca2+-dependent or Ca2+-independent pathways. Sirolimus arrests cell cycle progression by direct interaction with two intracellular proteins (immunophilin FK binding protein 12 (FKBP-12) and the mammalian target of rapamycin (mTOR), a multifunctional serine-threonine kinase). In cells, sirolimus binds to FKBP-12, and the resulting sirolimus-FKBP-12 complex then binds to and inhibits mTOR.
16163511|NCT01675947|Drug|Lidocaine|Lidocaine 2%
16163512|NCT01675934|Procedure|Retroflexion with the adult colonoscope.|
16163513|NCT01675934|Procedure|Retroflexion with the pediatric colonoscope.|
16163514|NCT01675921|Other|Facebook group|Facebook will be used to remind participants to take the ACT survey once every month for 12 months.
16163515|NCT01675908|Procedure|Stent Dysfunction|Rate of stent dysfunction (%) which includes persistent hyperbilirubinemia or cholangitis that warrant stent exchange by another ERCP.
16163516|NCT01675908|Procedure|Complications|Rates of procedural complications (%) such as pancreatitis, perforation or hemorrhage during stent placement will be assessed.
16163517|NCT01675895|Drug|Levobupivacaine lidocaine spinal anesthesia|Spinal anesthesia
16163518|NCT01675895|Drug|levobupivacaine Spinal anesthesia|spinal anesthesia
16163523|NCT01675869|Behavioral|Executive Training of Attention and Metacognition (ETAM)|ETAM is an 8-week intervention involving weekly concurrent child (n=~6 per group) and parent intervention groups. The ETAM groups will be 1 hour in length (except for the first session which will be 2 hours).
16163524|NCT01675869|Behavioral|Attention Control|Attention Control is an 8-week intervention involving weekly concurrent child (n=~6 per group) and parent groups that control for the effects of attention. The groups will be 1 hour in length (except for the first session which will be 2 hours).
16163525|NCT01675856|Other|Urgent endoscopy|Defined by oesophagogastroduodenoscopy within 6 hours of first presentation of Prince of Wales Hospital
16163526|NCT01675856|Other|Early endoscopy|Defined by oesophagogastroduodenoscopy within 24 hours of first presentation of Prince of Wales Hospital
16163527|NCT01675843|Procedure|Intrauterine insemination (IUI)|The male semen is obtained then processed by swim up technique and then introduced into the uterus by special catheter.
16163528|NCT01675830|Device|Heat Retention Head Wrap|Applied to infant's heads during the rewarming phase of CBP surgery
16163529|NCT01675804|Other|Computerized cognitive rehabilitation|- Computerized cognitive rehabilitation: 20 ninety-minute sessions of computerized cognitive rehabilitation.
16163530|NCT01675804|Drug|Ritalin|-drug therapy: 2 or 3 doses of 10 mg tablets of Immediate-release Methylphenidate (Ritalin) per day for 2 months.
16163531|NCT01675804|Other|Placebo CACR [PCACR]|PCACR: 20 ninety-minute sessions of Placebo computerized cognitive training.
16163532|NCT01675791|Biological|ALK tree AIT 0.5 DU|
16163533|NCT01675791|Biological|ALK tree AIT 1 DU|
16163534|NCT01675791|Biological|ALK tree AIT 2 DU|
16163535|NCT01675791|Biological|ALK tree AIT 4 DU|
16163536|NCT01675791|Biological|ALK tree AIT 7 DU|
16163537|NCT01675791|Biological|ALK tree AIT 12 DU|
16163538|NCT01675791|Biological|ALK tree AIT Placebo|
16163539|NCT01675778|Drug|Hydromorphone|a fixed dose (1 mg) of hydromorphone will be given to the study subjects
16163540|NCT01675765|Biological|Immunotherapy plus chemotherapy|live attenuated double deleted Lm
16163541|NCT01675765|Biological|Immunotherapy with cyclophosphamide plus chemotherapy|live attenuated double deleted Lm
16163542|NCT01675739|Behavioral|Short message service of mobile phone (SMS)|In SMS group, patients took 1st dose polyethylene glycol (PEG) 2L at 6-8pm the day before colonoscopy and then start to take 2nd dose PEG 2L after receiving Short message service of mobile phone (SMS) 6hours before afternoon colonoscopy.
16163543|NCT01675739|Drug|polyethylene glycol (PEG)|"No-SMS group took 1st 2L of PEG solution at 6-8 PM on the day before colonoscopy and started drinking the 2nd 2L PEG at about 6hours before the day of the colonoscopy.
~SMS group took 1st 2L PEG as same manner of No-SMS group and then started drinking the 2nd 2L PEG at about 6hours before the day of the colonoscopy after receiving scheduled SMS"
16163544|NCT01675726|Other|questionary on quality of life|
16163545|NCT01675713|Behavioral|Intensive lifestyle intervention|Lifestyle modification program focusing on increasing physical activity level, adjusting energy intake and learning coping strategies
16163546|NCT01675700|Drug|Nitroglycerin patch|Nitroglycerin 0.1 mg/hr patch
16163547|NCT01675687|Behavioral|Follow Up Support|inputs will be based on elements derived from cognitive behavioural therapy, acceptance and commitment therapy, mindfulness and awareness training
16163548|NCT01675674|Other|Dried blood spot test for MPS|The dried blood spot test uses a few drops of blood on filter paper to screen for mucopolysaccharidoses (MPS I, MPS II, MPS IVA and MPS VI in this study).
16163549|NCT01675661|Drug|N-Acetylcysteine|Study participants randomly assigned to the NAC arm will receive a 12-week course of N-Acetylcysteine (1200mg) twice daily. All participants will concurrently participate in weekly medication management sessions and twice-weekly contingency management interventions.
16163551|NCT01675648|Drug|Lofexidine|
16163554|NCT01675648|Drug|Placebo for Diazepam|
16163555|NCT01675635|Drug|OxyNorm Capsules|dosage:5mg,l0mg and 20mg dosage form:capsule frequency:every 6h, duration:24 hours
16163556|NCT01675635|Other|Morphine tablet|dosage: 10mg and 20mg; dosage form: tablet; frequency: every 6h; duration: 24 hours.
16163557|NCT01675622|Drug|Oxycodone|dosage: 5mg, l0mg and 20mg dosage form: capsule frequency: every 6h, duration: 5-8 days
16163558|NCT01675622|Drug|Morphine|Morphine tablets 10mg and 20mg, oral every 4-6 hours
16163559|NCT01675609|Drug|Placebo|1 drop in each eye daily for up to 35 days
16163560|NCT01675609|Drug|Brimonidine tartrate 0.025%|1 drop in each eye for up to 35 days
16163561|NCT01675596|Device|TAVR Implantation of the Transcatheter Aortic Valve Prosthesis|Operable subjects
16163562|NCT01675570|Drug|RX-10045|One drop of RX-10045 ophthalmic solution will be instilled in each eye, twice a day, approximately 12 hours apart for 28 days.
16163563|NCT01675570|Drug|Vehicle for RX-10045|One drop of RX-10045 placebo solution will be instilled in each eye, twice a day, approximately 12 hours apart for 28 days.
16163564|NCT01675557|Dietary Supplement|Vitamin D3|a single oral dose of vitamin D3
16163565|NCT01675557|Dietary Supplement|Vitamin D2|a single oral dose of vitamin D2
16163566|NCT01675557|Dietary Supplement|Placebo|a single oral dose of placebo
16163567|NCT01675544|Procedure|Electrocardiogram|EKG voltage changes between admission and discharge
16163568|NCT01675544|Procedure|Six minute walk test|
16163569|NCT01675531|Drug|Targin|Single arm for Targin
16163570|NCT01675518|Drug|ASP7991|oral
16163571|NCT01675518|Drug|Placebo|oral
16163572|NCT01675492|Device|LASIK|Surgeons will perform wavefront-guided LASIK based upon measurements obtained with the iDesign System
16163573|NCT01675479|Device|LASIK correction of hyperopic refractive errors|Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System
16163574|NCT01675466|Procedure|early laparoscopy|Laparoscopy under performed by the surgeon on duty or his/her deputy. The aim is to achieve this within 12 hours of randomisation. This will be performed under general anaesthetic and involve the necessary drugs. The procedure will require laparoscopy instruments. There will be a umbilical port which will be 10mm in size and one 5mm port below this. If pathology is found, a further port will be needed to perform treatment.
16163575|NCT01675466|Procedure|General anaesthesia|
16163576|NCT01675466|Device|Laparoscopic instruments|
16163577|NCT01675453|Drug|7.2% NaCl plus 6% hydroxyethyl starch 200/0.5|
16163578|NCT01675453|Drug|0.9% NaCl|
16163579|NCT01675440|Device|Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)|
16163580|NCT01675427|Other|Interleukin 28B testing|Blood sampling for ILB28 genotyping
16163581|NCT01675414|Other|evaluation visit by a pediatric gastroenterologist|medical history, physical exam completed by pediatric gastroenterologist
16163582|NCT01675401|Other|Weight-loss treatment|A very-low energy diet (Modifast Intensive) for 4-5 weeks providing 2.1 MJ/day in order to reduce body weight. After 4-5 weeks a mixed solid energy-restricted diet up to 4.2 MJ/day with a recommended composition for the following 1-2 weeks. Then, a diet matching their energy requirements to maintain newly achieved body weights (weight-stable conditions) for at least 2 weeks.
16163583|NCT01675401|Other|No-weight loss treatment|Maintenance of habitual diet and physical activity for 8 weeks to maintain body weights.
16163584|NCT01675388|Other|Hypothermia|Hypothermia to 33.5 deg C
16163585|NCT01675375|Device|Eye Shield|one application following refractive surgery
16163586|NCT01675362|Drug|Antioxidant group|They will be receive vitamins A, C, E and selenium (Selenium ACE) Dosage: Two tablets before ESWL Then 2 tablets every 8 hours after ESWL for one week
16163587|NCT01675362|Drug|Calcium Channel Blockers|They will receive Verapamil (Isoptin 80 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every 12 hours after ESWL for one week
16163588|NCT01675362|Drug|Angiotensin receptor blocker group|They will receive Losartan (Cozaar 50 mg) Dosage: One tablet 2 hours before ESWL Then one tablet every day after ESWL for one week
16163589|NCT01675362|Drug|Placebo|They will receive placebo
16163590|NCT01675349|Biological|Prick test Chenopodium album allergen extract|"This is an open, unblinded and non randomized biological as proposed by the Nordic Guidelines.
~Four concentrations of Chenopodium album allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm. This test will be referred to as the Titrated Skin Prick test."
16163591|NCT01675310|Drug|medical nutrition therapy + metformin|
16163592|NCT01675310|Behavioral|Medical nutrition therapy|medical nutrition therapy
16163593|NCT01675297|Drug|Risedronate/Cholecalciferol combination|Risendronate/Cholecalciferol combination once a week
16163594|NCT01675297|Drug|Risedronate|Risedronate once a week
16163595|NCT01675284|Biological|AT-301|Inactivated H5N1 Influenza Virion Vaccine
16163596|NCT01675271|Other|individual exercise|individual exercise and dietary prescription
16163597|NCT01675271|Other|general exercise|general exercise counselling
16163598|NCT01675258|Other|Salivary samples|Each participant will give a sample of saliva through spitting for 10 minutes in a sterile tube.
16163599|NCT01675245|Drug|No intervention|This is an observational study. Velcade will be administered as per the recommended regimen. (Velcade, 1.3 mg/m2/dose, administered intravenously on days 1, 4, 8 and 11, for 2 weeks)
16163600|NCT01675232|Other|Soak and smear|Corticosteroid ointment applied to wet skin once a day and dry skin once a day.
16163601|NCT01675232|Other|Dry Smear|Corticosteroid ointment applied to dry skin twice a day.
16163602|NCT01675219|Procedure|white light TUR-BT|traditional transurethral bladder tumor resection
16163603|NCT01675219|Procedure|blue light TUR-BT|photodynamic transurethral bladder tumor resection
16163604|NCT01675219|Drug|optimized MMC|six weekly optimized mitomycin-C instillations
16163605|NCT01675219|Drug|single immediate chemotherapy instillation|single immediate post TUR-BT epirubicin (2mg/ml, total of 100 ml) instillation
16163606|NCT01675206|Dietary Supplement|Vitamin K2 supplementation|
16163694|NCT01674530|Drug|Lubiprostone|24 mcg Capsules to be given in the experimental arm with Placebo Of AMITIZA
16163607|NCT01675193|Behavioral|Disinvestment protocol|Omission of population-based child vision screening visits at 6-9 and 14-24 months: Children in the intervention group will not be eye screened at age 6-24 months
16163608|NCT01675180|Other|Information|Women in the intervention group will recieve information and counseling on oral health care during pregnancy
16163609|NCT01675180|Other|Control|No intervention
16163610|NCT01675167|Drug|Buprenorphine|Buprenorphine HCl Buccal Film at doses ranging from 150-900 mcg twice daily
16163611|NCT01675167|Drug|Placebo|Matching Placebo Buccal Film twice daily
16163612|NCT01675154|Drug|SLx-4090 placebo|Given for 4 weeks
16163613|NCT01675154|Drug|Orlistat Placebo|Given for 4 weeks
16163614|NCT01675154|Drug|Orlistat|Given for 4 weeks
16163615|NCT01675154|Drug|Slx-4090|Given for 4 weeks
16163616|NCT01675141|Drug|Lenalidomide|10 mg oral daily, on days 1-21 of repeated 28 day cycles, to continue until disease progression or unacceptable toxicity.
16163617|NCT01675128|Drug|ISIS 183750|
16163618|NCT01675128|Drug|Irinotecan|
16163619|NCT01675115|Drug|BNG-1|BNG-1 3 grams TID for 4 weeks
16163620|NCT01675115|Drug|Aspirin|Aspirin 100 mg QD for 4 weeks
16163621|NCT01675089|Drug|Zoledronic acid|The treatment group will receive 15-minute intravenous administration of zoledronic acid (5 mg) in a single dose at the time of kidney transplantation and vitamin D replacement. The aim of vitamin D replacement will be serum levels of 25 (OH) vitamin D above 30 ng/ml.
16163622|NCT01675076|Drug|Dabigatran|NOAC
16163623|NCT01675076|Drug|Rivaroxaban|NOAC
16163624|NCT01675076|Drug|Apixaban|NOAC
16163625|NCT01675063|Device|Retia Non-Invasive Sensors|Three adhesive sensor patches (similar to ECG patches) will be placed on the chest and a sensor similar to a pulse oximeter will be placed on the toe. The sensors will be connected to an electrical amplifier that produces a waveform.
16163626|NCT01675050|Drug|Cyproheptadine|4 weeks of cyproheptadine or placebo with crossover to the other
16163627|NCT01675050|Drug|sugar pill|4 weeks of cyproheptadine or placebo with crossover to the other
16163628|NCT01675037|Other|Biological evaluation|Complete hypothalamic-pituitary hormonal evaluation
16163629|NCT01675024|Drug|Rotigotine, Period 1|"Formulation: transdermal
~Dosage: 2 mg / 24 hours once at Day 2
~Frequency: once every 24 hours
~Duration: from Day 1 to Day 3"
16163630|NCT01675024|Drug|Rotigotine, Period 2|"Formulation: transdermal
~Dosage: 2 mg / 24 hours for 3 days from Day 7 to Day 9, 4 mg / 24 hours for 3 days from Day 10 to Day 12
~Frequency: once every 24 hours
~Duration: from Day 1 to Day 3"
16163631|NCT01675011|Device|Embozene® Microspheres|
16163632|NCT01675011|Device|Embosphere®|
16163633|NCT01674985|Biological|Microtransplantation|Infusion of G-CSF mobilized HLA-mismatched peripheral blood stem cells (G-PBSC)
16163634|NCT01674972|Other|Oral glucose tolerance test|Oral intake of 75 g glucose after overnight fast
16163635|NCT01674959|Radiation|concurrent chemoradiation|"postoperative Intensity-modulated radiotherapy (IMRT) combined with capecitabine for high risk gastric cancer patients Radiation: concurrent chemoradiotherapy Postoperative radiotherapy regimen: Therapy plan system was formulated by Computed tomographic (CT) simulation. Radiation was delivered with 6MV photons. Radiotherapy consisted of 4500 cGy of radiation at 180 cGy per day, five days per week for five weeks, to the tumor bed, to the margins of resection or the stoma, to the regional nodes. Protection of spinal cord, heart, liver and kidney should be considered.
~Postoperative chemotherapy regimen: capecitabine( 1,600 mg/m2 per day for 5 weeks)."
16163636|NCT01674946|Other|saline|intraduodenal perfusion
16163637|NCT01674946|Other|bile acid (CDCA, chenodeoxycholic acid)|intraduodenal perfusion
16163638|NCT01674946|Other|oleanolic acid|intraduodenal perfusion
16163639|NCT01674946|Dietary Supplement|oleic acid|intraduodenal perfusion
16163640|NCT01674933|Drug|Duraphat® Fluoride Varnish|0.25 ml per application will be painted on tooth surfaces by a Childsmile trained Extended Duties Dental Nurse, currently registered with the UK General Dental Council
16163641|NCT01674933|Behavioral|treatment as usual|includes supervised toothbrushing, distribution of toothbrushes and toothpaste and oral health advice given at nursery school.
16163642|NCT01674920|Behavioral|Choices|The 12-week intervention included 1.5 hour classes each week. Topics included nutrition, physical activity, and psychosocial skills based in Resiliency.
16163643|NCT01674881|Other|Mindfulness-Based Cognitive Therapy|"MBCT consists of 8 sessions, incl. 1 whole-day session, weekly meetings of app. 2 hours duration. Daily homework (app. 30-45 min).
~Group format (app. 20 persons pr. group). Two trained instructors will manage the groups, both are MSc cand.psych, PhD."
16163644|NCT01674881|Other|Waitlist|Waitlist: participants are offered the intervention (MBCT) after the completion of the main study
16163645|NCT01674868|Drug|fluoxetine|20 mg daily for 90 days starting day 5-10 after stroke.
16163646|NCT01674868|Drug|placebo|subjects will take one pill po daily for 90 days.
16163647|NCT01674855|Drug|PEG-G-CSF|Prefilled syringe, 6mg/day, single dosing per cycle, for 6 cycle
16163648|NCT01674855|Drug|G-CSF|Vial, 100ug/m2/day, multiple dosing per cycle(daily administration, up to 10 days), for 6 cycle
16163649|NCT01674842|Radiation|Radiation Therapy|Once daily, Monday - Friday for six weeks
16163650|NCT01674842|Drug|Cisplatin|Intravenously, once weekly for six weeks
16163651|NCT01674829|Biological|MA09-hRPE|
16163652|NCT01674816|Device|Repeated Measurements of Knee Alignment and Kinematics|Repeated Measurements of Knee Alignment and Kinematics using tools developed by Eiffel Medtech Inc.
16163653|NCT01674816|Device|Computer Guidance of Surgical Actions|Computer Guidance of Surgical Actions using tools developed by Eiffel Medtech Inc.
16163654|NCT01674803|Device|Orsiro|biodegradable polymer sirolimus eluting stent
16163655|NCT01674803|Device|Synergy|biodegradable polymer everolimus eluting stent
16163656|NCT01674803|Device|Resolute Integrity|durable polymer zotarolimus-eluting stent
16163657|NCT01674790|Behavioral|Aerobic training|One 20-min session of body weight support treadmill training at moderate to high intensity (60-70% heart rate reserve) 5 days/week for 6-weeks.
16163658|NCT01674790|Behavioral|Cognitive training|One 20-min session of cognitive training (computerized dual n-back training program) 5 days/week for 6 weeks.
16163695|NCT01674530|Drug|Lubiprostone|24 mcg Capsules with placebo of Lubiprostone ( Manufactured by Dr Reddy's Laboratories Ltd)
16163659|NCT01674790|Behavioral|Range of motion exercise|One 20-min session of range of motion exercise (non-aerobic passive and active movement of upper and lower extremity) 5 days/week for 6-weeks.
16163660|NCT01674790|Behavioral|Unstructured mental activity|One 20-min session of unstructured mental activity (e.g., listening to light novels on tape) 5 days/week for 6-weeks.
16163661|NCT01674777|Drug|ASP1941|oral
16163662|NCT01674764|Procedure|Early surgical intervention|Open surgical stabilization and decompression (anterior, posterior or circumferential); and/or Closed reduction and external fixation
16163663|NCT01674764|Procedure|Late surgical intervention|Open surgical stabilization and decompression (anterior, posterior or circumferential); and/or Closed reduction and external fixation
16163664|NCT01674751|Other|Pre-ordering program|"During the 4 week intervention phase, participants use the pre-ordering program, receive a novel, smart receipt upon checkout that will detail the caloric and fat content of what they ordered, and receive price discounts for select low calorie and low fat items. The pre-ordering system is designed to provide the opportunity for the individual to see what is available along with nutritional information and to make a selection ahead of time."
16163665|NCT01674738|Drug|Pemetrexed|500 mg/m2 i.v. on day 1 (three-week cycle)
16163666|NCT01674738|Drug|Cisplatin|75 mg/m2 i.v. on day 1 (three-week cycle)
16163667|NCT01674738|Drug|Bevacizumab|7,5 mg/kg i.v. on day 1 (three-week cycle)
16163668|NCT01674725|Drug|ABT-450/r/ABT-267, ABT-333|Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
16163669|NCT01674725|Drug|Ribavirin|Tablet
16163670|NCT01674712|Drug|Fixed Combination of Fenofibrate/simvastatin 145/20 mg|Fenofibrate/simvastatin oval biconvex film-coated tablet, 145 mg / 20 mg, once daily, 12 weeks
16163671|NCT01674712|Drug|Simvastatin 20 mg|Simvastatin generic tablet over-encapsulated, 20 mg, once daily, 12 weeks
16163672|NCT01674712|Drug|Fenofibrate 145 mg|Fenofibrate, tablet, 145 mg, once daily, 12 weeks
16163673|NCT01674712|Drug|Fixed Combination of Fenofibrate/simvastatin 145/40 mg|Fenofibrate/simvastatin film-coated tablet 145 mg / 40 mg, once daily, 12 weeks
16163674|NCT01674712|Drug|Simvastatin 40 mg|simvastatin, generic tablet over-encapsulated, 40 mg, once daily, 12 weeks
16163675|NCT01674699|Device|EXCOR Pediatric|Ventricular Assist Device
16163676|NCT01674686|Drug|Sarpogrelate|Sarpogrelate 100mg twice a day
16163677|NCT01674686|Drug|Atorvastatin|Atorvastatin 80mg daily
16163678|NCT01674647|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Rivaroxaban 20 mg orally once daily; subjects with moderate renal impairment (ie, CrCl of 30 to 49 mL/min, inclusive) will receive the adjusted dose of 15 mg orally once daily in the study
16163679|NCT01674647|Drug|Vitamin K antagonist (VKA)|VKA orally once daily titrated to a target international normalized ratio (INR) of 2.5 (range 2.0-3.0, inclusive); the VKA type (eg, warfarin, acenocoumarol, phenprocoumon, fluindione, etc) will be assigned by the investigator according to local treatment standards
16163680|NCT01674634|Biological|XIAFLEX / XIAPEX|injection (0.58 mg after reconstitution with sterile diluent [0.3 mg/mL calcium chloride dihydrate in 0.9% sodium chloride])
16163681|NCT01674621|Drug|Abaloparatide Transdermal (50 mcg)|Abaloparatide Transdermal Microneedle Active Patch
16163682|NCT01674621|Drug|Abaloparatide Transdermal (100 mcg)|Abaloparatide Transdermal Microneedle Active Patch
16163683|NCT01674621|Drug|Abaloparatide Transdermal (150 mcg)|Abaloparatide Transdermal Microneedle Active Patch
16163684|NCT01674621|Drug|Abaloparatide Injection (80 mcg)|Abaloparatide Subcutaneous Injection
16163685|NCT01674621|Drug|Abaloparatide Placebo|Abaloparatide Transdermal Microneedle Placebo Patch
16163686|NCT01674595|Biological|AVANZ olea|Immunotherapy Olea europaea
16163687|NCT01674582|Other|MRI, neuropsychological evaluation, blood sampling|"MRI at timepoints given above, neuropsychological testing after surgery, but before radiotherapy or chemotherapy.
~Neuropsychological testing month 3 during treatment. Neuropsychological testing after 1 year. Neuropsychological testing after 2 years."
16163688|NCT01674569|Drug|X-82 oral|X-82 oral for 24 weeks or until unacceptable toxicity develops
16163689|NCT01674569|Drug|ranibizumab (Lucentis)|Rescue treatment with intravitreal ranibizumab (Lucentis) as needed
16163690|NCT01674556|Drug|Gemzar|Gemcitabine in combination with ultrasound (US) contrast agent under sonication
16163691|NCT01674543|Other|Resistance Training|"The patients in this group will given a progressive resistance training program twice per week (Tuesday and Thursday) for 20 weeks. The training program followed the American College of Sports Medicine guidelines on resistance training for adults. Training sessions will performed at the same time of day (between 1 pm and 5 pm). The chosen exercises focused on the large muscle groups that are important for the patients' daily routines. The exercises include the leg press, leg curl, vertical traction, chest press, arm extension, arm curl and abdominal crunch using equipment manufactured by Technogym®.
~Every training session will preceded by 5 minutes of warm-up on a Life Fitness® motorized stepper at a constant velocity of 4 km/h. A 1 RM test will be to determine the load settings, as performed in previous studies. The load will readjusted throughout training according to the results of a 1 RM test after the 2nd month of training (the 8th week of training) for each exercise."
16163692|NCT01674543|Other|Concurrent Training|"The patients in this group will given a progressive concurrent training program, composed of aerobic and resistance training in the same session, twice per week (Tuesday and Thursday) for 20 weeks. Training sessions will performed at the same time of day (between 1 pm and 5 pm). the aerobic training will be conducted in Lifefitness 9700HR treadmill and the chosen exercises for resistance training focused on the large muscle groups that are important for the patients' daily routines. The exercises include the leg press, leg curl, vertical traction, chest press, arm extension, arm curl and abdominal crunch using equipment manufactured by Technogym®.
~A 1 RM test will be to determine the load settings, as performed in previous studies. The load will readjusted throughout training according to the results of a 1 RM test after the 2nd month of training (the 8th week of training) for each exercise."
16163693|NCT01674543|Other|Control|Patients in this group will to the CEPE twice per week (Tuesday and Thursday) for 20 weeks and performed the same training protocol as the RESEX group. However, the equipment load (weight on each apparatus) is kept at the minimum (below 5% of 1 Repetition maximum - RM) throughout the treatment, without modifying the protocol. Patients execute 2 sets of 15 repetitions with a 1-minute rest interval on all of the equipment.
16163696|NCT01674530|Drug|Placebo|24 mcg capsules of both experimental Lubiprostone and AMITIZA
16163697|NCT01674517|Drug|Montelukast sodium chewable tablets 4mg and 5mg|Montelukast sodium chewable tablets 4mg and 5mg
16163698|NCT01674504|Drug|Montelukast sodium chewable tablets 4 mg and 5 mg|Montelukast sodium chewable tablets 4mg and 5mg
16163699|NCT01674491|Dietary Supplement|black soy peptide|black soy peptide: 4.5g/day for 8 weeks
16163700|NCT01674478|Dietary Supplement|Microlipid with fish oil|Fish oil will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which both will be continued until reanastomosis.
16163701|NCT01674478|Dietary Supplement|Microlipid|A small amount (ml) of Microlipid to match the amount of fish oil in ML/FO group will start with initial feeding after ostomy placement and Microlipid will start once infant tolerating enteral feeds at 20 ml /kg/d while weaning the Intralipid, which will be continued until reanastomosis.
16163702|NCT01674465|Biological|Hypoxyprobe-1|Hypoxyprobe-1 is a biological marker used to detect oxygen levels in tissue;subjects will receive and intravenous solution for 20 minutes containing 500mg/m^2 two-three hours prior to their standard of care biopsy
16163703|NCT01674452|Behavioral|home-based group (HBG)|Participants in the home-based group (HBG) were advised to exercise, a minimum of 4 times per week, but they were encouraged to exercise a total of 5-7 days per week. After individual assessment, a group of home-exercise selected of the manual was explained and performed one by one. The home-exercises were re-executed at each fortnightly visit, when necessary corrections were made and the next step stipulated by manual was taken, according to the patient's progress.
16163704|NCT01674452|Behavioral|supervised exercise group (SEG)|Patients in the supervised exercise training group (SEG) participated in supervised individual exercise sessions 2 times per week. A physical therapist supervised these sessions. Exercise sessions included: 30 minutes of global exercises that involved stretching, range of motion, muscle strengthen and another 30 minutes of functional training (gait, balance and use of the arm in daily activities).
16163705|NCT01674439|Procedure|Supplementation of ADRC|Isolation of ADRC from half of the aspirated fat and supplementation of the fat grafts with these cells
16163706|NCT01674439|Procedure|Without supplementation of ADRC|Standard fat graft preparation
16163707|NCT01674426|Behavioral|Cognitive behavior therapy|16 sessions of 45 minutes each to review stress management
16163708|NCT01674413|Drug|Adalimumab|Adalimumab 40 mg q 2 weeks, with placebo loading of 3 syringes/1 syringe at Weeks 0/2, 12/14, 24/26, and 36/38
16163709|NCT01674413|Drug|Adalimumab PRN|"160 mg/80 mg Adalimumab at Weeks 0 and 2, followed by 1 syringe SC placebo q 2 weeks (except at Weeks 12/14, 24/26, and 36/38), with
~PRNLOADing of 160 mg/80 mg Adalimumab at Weeks 12/14, 24/26, or 36/38 if most recent FCP is ≥167 mcg/gram of stool,
~Or, placebo loading of 4 syringes/2 syringes at Weeks 12/14, 24/26, and 36/38 if most recent FCP is < 167 mcg/gram of stool."
16163710|NCT01674413|Drug|Placebo|1 syringe of placebo SC q 2 weeks, with additional placebo loading of 3 syringes/1 syringe at Weeks 0/2, 12/14, 24/26, and 36/38 Weeks.
16163711|NCT01674387|Device|acupuncture|56 patients (the EA group) receive the acupuncture treatment at nine acupuncture points: Dazhui (GV14), bilateral Jianzhongshu (SI15), bilateral Jingbailao (EX HN15), bilateral Jiaji (EX-B2) of cervical positive reaction plane (taking two pairs). Besides, bilateral Jianzhongshu (SI15) and bilateral Jiaji (EX-B2) receive the electro acupuncture treatment, with dilatational wave. All the needles retained for 20 minutes, one treatment every other day, 10 times a course, and the treatment assessed after a course.
16163712|NCT01674387|Other|comprehensive treatment|Other 56 patients (the matched group) receive the comprehensive treatment, including traction and TENS therapy. Each treatment 20 minutes, one treatment every other day, 10 times a course, and the treatment assessed after a course.
16163713|NCT01674374|Other|placebo|Given PO
16163714|NCT01674374|Procedure|quality-of-life assessment|Ancillary studies
16163715|NCT01674374|Other|questionnaire administration|Ancillary studies
16163716|NCT01674374|Drug|Vaccinium myrtillus/Macleaya cordata/Echinacea angustifolia extract granules|Given PO
16163717|NCT01674361|Drug|Bitopertin|Bitopertin once daily orally.
16163718|NCT01674361|Drug|Placebo|Placebo matched to bitopertin once daily orally.
16163719|NCT01674361|Drug|SSRI|Participants will continue their background SSRI treatment as per standard of care at the same dose taken during the 8 weeks prior to Day 1. Protocol does not enforce any particular SSRI drug or regimen.
16163720|NCT01674348|Drug|P2202|Novel oral drug with potent and selective 11 beta-hydroxysteroid dehydrogenase type 1 (11b-HSD1) inhibitory properties, being developed for the management of type 2 diabetes mellitus
16163721|NCT01674348|Drug|Placebo|Placebo
16163722|NCT01674335|Behavioral|Operant Learning|"The present therapist manual focuses on the operant learning approach, which emphasizes the use of positively reinforced activity quotas that are time and/or goal contingent, rather than pain-contingent, using a gradually increased activity-rest cycling approach (Fordyce, 1976).
~This manual includes a total of 10 group sessions (duration: 2 hours each), two booster sessions at 3 and 6 months post-intervention (duration: 1 hour each) and a 1 follow-up session at 12 months post-intervention (duration: 1 hour). The 10 group sessions are held on a weekly basis for the 2 first months, and every 2 weeks for the remaining 3rd months."
16163723|NCT01674335|Behavioral|Energy Conservation|"The present therapist manual focuses on the energy conservation approach, which emphasizes management of participant energy expenditure, and seeks to achieve a balance between accomplishing important day-to-day activities and resting in order to reduce or avoid pain and fatigue (Hammond, 2004).
~This manual includes a total of 10 group sessions (duration: 2 hours each), two booster sessions at 3 and 6 months post-intervention (duration: 1 hour each) and a 1 follow-up session at 12 months post-intervention (duration: 1 hour). The 10 group sessions are held on a weekly basis for the 2 first months, and every 2 weeks for the remaining 3rd months."
16163724|NCT01674322|Drug|Ibrutinib|Type=exact number, unit=mg, number=50-140, form=solution, route=oral. Participants will receive a single oral solution dose of 50 mg to 140 mg -ibrutinib containing 1480 kBq (40 µCi) of 14C-labeled ibrutinib, with a total radiation burden of approximately 0.916 mSv.
16163725|NCT01674309|Drug|FOLFORINOX|INTRAVENOUS administration
16163726|NCT01674283|Drug|Glucagon|
16163727|NCT01674283|Drug|placebo|
16163728|NCT01674270|Drug|Degarelix|
16163729|NCT01674270|Drug|Casodex|
16163730|NCT01674270|Drug|LHRH Agonist|
16163925|NCT01672801|Drug|Placebo|oral administration
16264590|NCT00902772|Drug|Placebo|
16163731|NCT01674257|Other|USPIO (ferumoxytol)-enhanced MRI scan|Two separate MRI scans will form this intervention. A baseline scan followed by an infusion of USPIO (ferumoxytol), followed by another MRI scan.
16163732|NCT01674257|Radiation|18f-Fluoride PET/CT scan|
16163733|NCT01674257|Radiation|18F-Flurodeoxyglucose PET/CT scan|
16163734|NCT01674244|Behavioral|Integrative Exercise|
16163735|NCT01674244|Behavioral|Monitor Only Waitlist|
16163736|NCT01674231|Other|Grape in the form of freeze-dried whole grape powder|60g freeze-dried whole grape powder with 296mg polyphenols per day for 4 weeks.
16163737|NCT01674231|Other|Grape powder placebo|60g control food (matched for calories, low in polyphenols, and indistinguishable from active intervention) per day for 4 weeks.
16163738|NCT01674218|Drug|Moxifloxacin|Moxifloxacin will be given orally to the following treatment groups, in combination with either PA-824 or PA-824 placebo: Treatment D: 400 mg + PA-824 placebo; Treatment E: 400 mg + PA-824 400 mg. Subjects will cross-over to the next Treatment Group after a 6-day washout period.
16163739|NCT01674218|Drug|PA-824|PA-824 will be given orally to the following treatment groups, together with either moxifloxacin or moxifloxacin placebo: Treatment B: 400 mg + moxifloxacin placebo; Treatment C: 1000 mg + moxifloxacin placebo; Treatment E: 400 mg + moxifloxacin 400 mg. Subjects will cross-over to the next Treatment Group after a 6-day washout period.
16163740|NCT01674218|Other|Placebo|Placebo tablets to match Moxifloxacin or PA-824 will be given orally, in combination with either moxifloxacin or PA-824: Treatment A: PA-824 placebo + moxifloxacin placebo; Treatment B: PA-824 400 mg + moxifloxacin placebo; Treatment C: PA-824 1000 mg + moxifloxacin placebo Treatment D: PA-824 placebo + moxafloxacin 400 mg. Subjects will cross-over to the next Treatment Group after a 6-day washout period.
16163741|NCT01674205|Biological|A/swine/Missouri/4296424/2006 (H2N3) x A/Ann Arbor/6/60 ca (H2N3 MO 2006/AA ca)|
16163742|NCT01674205|Biological|A/chicken/Hong Kong/G9/97 (H9N2) x A/Ann Arbor/6/60 ca (H9N2 G9/AA ca)|
16163743|NCT01674205|Biological|2012-2013 trivalent seasonal live attenuated influenza vaccine (FluMist®)|
16163744|NCT01674205|Biological|Vaccine placebo (Leibovitz-15 [L-15])|
16163745|NCT01674205|Biological|Vaccine placebo (FluMist®)|
16163746|NCT01674192|Drug|prucalopride|single dose of 2 mg prucalopride
16163747|NCT01674166|Drug|prucalopride|single dose 0.03 mg/kg prucalopride open label
16163748|NCT01674153|Procedure|Intra-dialytic exercise|Perform intra-dialytic exercise of three bouts in 4 hours dialysis session. Each patient will perform exercise on Monark 881E rehab trainer (widely used in routine dialysis settings). The exercise intensity will be prescribed based on achievement of 50% of maximum heart rate for each recruited subject.
16163749|NCT01674140|Drug|anastrozole|Given orally
16163750|NCT01674140|Drug|everolimus|Given PO
16163751|NCT01674140|Drug|exemestane|Given orally
16163752|NCT01674140|Drug|goserelin acetate|Given subcutaneously or intramuscularly
16163753|NCT01674140|Drug|letrozole|Given orally
16163754|NCT01674140|Drug|leuprolide acetate|Given subcutaneously or intramuscularly
16163755|NCT01674140|Drug|tamoxifen citrate|Given PO
16163756|NCT01674140|Other|placebo|Given PO
16163757|NCT01674127|Drug|Methyldopa|
16163758|NCT01674127|Drug|Placebo|
16163759|NCT01674114|Procedure|TAP block|
16163760|NCT01674114|Procedure|control|
16163761|NCT01674101|Other|Endurance|Endurance exercise will consist of ambulating with assistive devices as needed, upper extremity (UE) ergometer, and/or playing the Wii.
16163762|NCT01674101|Other|Strengthening|Strengthening exercises will involve both UE's and LE's. For UE's, bicep curls, triceps curls, shoulder flexion, and/or press-ups from the therapy mat or wheelchair will be included. For the LE's, bridging, long arc quads, hamstring curls, calf raises in standing, single LE squats, and/or dorsiflexion (DF) in supine will be performed on the uninvolved extremity.
16163763|NCT01674101|Other|Stretching|Stretching will consist of ankle stretch into DF in supine or long sitting, hamstring stretch in supine with hip flexed to 90 degrees, and trunk extension in sitting.
16163764|NCT01674101|Other|Home exercise program|All participants will be given a tailored home exercise program (HEP) including endurance exercises, strengthening, and stretching exercises to be completed on days they do not have PT. If the participants return home, they will be asked to complete the HEP at least 3 days per week. The physical therapist will contact the participant weekly to modify the HEP if necessary and determine compliance.
16163765|NCT01674062|Drug|Pertuzumab|Loading dose 840 mg IV on Day 2 of Cycle 1, followed by 420 mg every 3 weeks thereafter, until disease progression or unacceptable toxicity.
16163766|NCT01674062|Drug|Trastuzumab|2 mg/kg IV once weekly, or as 6 mg/kg every 3 weeks, beginning on Day 1 of Cycle 1 and on Day 1 of each 3-week cycle thereafter until disease progression or unacceptable toxicity.
16163767|NCT01674049|Dietary Supplement|Immediate Nutrition|Nutritional supplement consumed either immediately following a 40min resistance exercise bout
16163768|NCT01674049|Dietary Supplement|Nutrition 3 hours Post-Bout|Nutritional supplement (600g low-fat chocolate milk) consumed three hours after the exercise bout
16163769|NCT01674049|Other|Resistance Exercise|A single 40 minute circuit-style bout of resistance exercise
16163770|NCT01674036|Drug|Genz-682452|Capsules for oral administration.
16163771|NCT01674036|Drug|Placebo|Placebo to Genz-682452
16163772|NCT01674010|Drug|ELND005|
16163773|NCT01674010|Drug|Lamotrigine|
16163774|NCT01674010|Drug|Valproic acid|
16163775|NCT01674010|Drug|Placebo|
16163776|NCT01673997|Drug|Metoprolol Succinate|Metoprolol Succinate ER Tablets 200 mg
16163777|NCT01673984|Drug|Decapeptyl® SR 22.5mg|22.5mg, intramuscular injection, given on day 1 / month 0 & month 6 (+/- 7 days).
16163778|NCT01673984|Drug|Decapeptyl® SR 11.25mg; Prostap® 3 DCS 11.25mg; Zoladex® LA 10.8mg|For Decapeptyl® SR 11.25mg: 11.25 mg, intramuscular injection For Prostap® 3 DCS 11.25mg: 11.25mg, depot injected subcutaneously For Zoladex® LA 10.8mg: 10.8mg, depot injected subcutaneously into anterior abdominal wall
16163779|NCT01673958|Other|Exercise|Comparison between stair descending and stair ascending training
16163883|NCT01673139|Behavioral|Interval exercise|4 times of 4 minutes intervals at an intensity of 90-95% of maximum heart rate and active pauses of 3 minutes between intervals. 3 times a week for 3 years.
16163926|NCT01672801|Drug|Nimodipine|oral administration
16163780|NCT01673945|Device|EUS-guided fine needle aspiration|Each patient will undergo examination with the CLA-EUS or the FV-EUS, which will be selected based on the randomization process. FV-EUS will be performed using the newly available FV -EUS scope (TGF-Y0001-UC) that is compatible with last generation Aloka alpha 10. First, search of the presumed lesion will be performed and once visualize, its characteristics (size, echogenicity, margins, etc) will be recorded on data collection sheet. Fine needle aspiration will be performed under EUS guidance using a 19- ,22- or a 25-gauge fine needle or procore needles depending on endoscopist's preference
16163781|NCT01673932|Biological|UCBMC|Transplant 10-40 million viable UCBMC suspension into brain adjacent to the infracted site
16163782|NCT01673932|Procedure|surgery|
16163783|NCT01673919|Drug|tocilizumab [RoActemra/Actemra]|8 mg/kg iv every 4 weeks, 104 weeks
16163784|NCT01673906|Drug|Diagnostic work up|Patients will undergo MDCT, PET and EUS. Every attempt will be made to achieve a pre-operative cytologic diagnosis of any primary lesion by EUS-FNA. All diagnostic tests (MDCT, PET, EUS) should be performed during a two month time span, in this fixed order. The nuclear medicine doctor will be blinded of findings of MDCT. The gastroenterologist will be blinded about the findings of MDCT and PET until he has completed the diagnostic EUS. For ethical reasons, the findings of MDCT and PET will be disclosed to her/him, while the patient is still sedated in the operating room, just before the FNA. The minimal technical requirement for the techniques, the requested levels of clinical competence of the operators and the procedure for critical revision of radiological and cytological and histological specimens are detailed in the protocol. For PET any 68Ga -labeled-octreotide analogue will be allowed. Before EUS, an extended-esophagogastroduodenoscopy (until the Treitz) until will be performed.
16163785|NCT01673893|Device|ClearWay™ Rx catheter|
16163786|NCT01673880|Drug|E2006|2.5 mg, 10 mg, and 25 mg E2006 tablets
16163787|NCT01673867|Biological|Nivolumab|
16163788|NCT01673867|Drug|Docetaxel|
16163789|NCT01673854|Drug|Ipilimumab|
16163790|NCT01673854|Biological|Vemurafenib|
16163791|NCT01673841|Procedure|Relative and absolute cerebral oxygen saturation (rScO2) measurements.|
16163792|NCT01673828|Drug|Allopregnanolone injection|Allopregnanolone intravenous solution in 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium
16163793|NCT01673828|Drug|Placebo injection|Placebo intravenous solution, 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium
16163794|NCT01673815|Other|Video (played on a computer monitor)|The intervention is a video (of the patient or caregiver's choice) which is played on a computer monitor during the fundoscopic examination.
16163795|NCT01673802|Drug|CT scan|Gadoxetate (Eovist) enhanced dual energy CT
16163796|NCT01673789|Device|Stem Cell Educator|For the treatment, commonly the left (or right) median cubital vein, a patient's blood is passed through a Blood Cell Separator that isolates the lymphocytes from the blood according to the recommended protocol by manufacture; consequently, the collected lymphocytes were transferred into the Stem Cell Educator and treated by CB-SC; after that, the educated cells return the blood back to the patient via a dorsal vein of hand. During the MCS+ collection, the whole blood flow rate was maintained at 35 mL/min. The whole procedure was scheduled for 8 ~ 9 hrs.
16163797|NCT01673776|Device|PulsioFlex® Monitoring|"goal directed therapy according to PulsioFlex® Monitoring- measurements
~femoral catheter
~extended perioperative monitoring
~nutritional supplementation, (if necessary)"
16163798|NCT01673763|Device|Stent insertion into the main pancreatic duct|Stent insertion into the main pancreatic duct
16163799|NCT01673750|Other|Questionnaire|The primary outcome, characterizing body image among HIV infected adolescents, will be measured using a questionnaire administered to study participants through Audio Computer Assisted Self-Interview (ACASI) technology.
16163800|NCT01673737|Drug|SAR260301|Pharmaceutical form: film-coated tablets Route of administration: oral
16163801|NCT01673737|Drug|Vemurafenib|Pharmaceutical form: film-coated tablets Route of administration: oral
16163802|NCT01673724|Drug|pramipexole|pramipexole
16163803|NCT01673724|Drug|Bromocriptine|bromocriptine
16163804|NCT01673711|Drug|deuterated phenanthrene tetraol|Given PO
16163805|NCT01673711|Drug|pharmacological study|Correlative studies
16163806|NCT01673711|Drug|laboratory biomarker analysis|Correlative studies
16163807|NCT01673698|Device|ReShape Duo balloon|
16163808|NCT01673698|Other|Diet counseling|
16163809|NCT01673698|Other|Exercise counseling|
16163810|NCT01673685|Device|Portable Oxygen|
16163811|NCT01673672|Biological|CYT003|7 subcutaneous injections, weekly/biweekly within 10 weeks
16163812|NCT01673672|Biological|Placebo|7 subcutaneous injections, weekly/biweekly within 10 weeks
16163816|NCT01673646|Drug|Pasireotide LAR|Intramuscular administration of pasireotide LAR was repeated every month (1 month = 28 days) for 12 months in core phase. It was permitted to increase the dose up to 60 mg in a patient showing the following biochemical test results after 3 and 6 months of study treatment: mean GH levels ≥2.5 µg/L and/or IGF-1 > ULN. In the event of any problem with tolerability, it was permitted to reduce the next lower dosage level at any time.
16163817|NCT01673620|Drug|Montelukast 10 mg/loratadine 10 mg|Montelukast 10 mg/loratadine 10 mg tablet administered once daily
16163818|NCT01673620|Drug|Placebo|Matching placebo tablet administered once daily
16163819|NCT01673607|Procedure|Biopsie liver|
16163820|NCT01673594|Drug|SODAS MPH|Adults with ADHD will receive open-label SODAS MPH
16163821|NCT01673594|Drug|Naltrexone|"Subjects randomized to the active double-blind group will receive Naltrexone HCl"
16163822|NCT01673581|Other|Survey|
16163823|NCT01673568|Device|ETO garments|patients wearing abdominal binder for 7 days postoperatively
16163824|NCT01673555|Drug|GSK1278863|GSK1278863
16163825|NCT01673555|Drug|Placebo|Placebo
16163826|NCT01673542|Drug|Lidocaine-Prilocaine 5%|
16163827|NCT01673542|Drug|DEXERYL|
16163828|NCT01673529|Drug|SB705498|1%, 3% and 5% (w/w) of SB705498 will be used in part A of the study. One dose will then be selected based on criteria explained in the protocol for use in Part B of the study.
16163829|NCT01673529|Drug|Placebo|Placebo to match SB705498 will be used in both Part A and Part B of the study.
16163830|NCT01673516|Procedure|The SymplicityTM Renal Denervation System|For patients who will be randomly assigned to undergo renal denervation (group RDN), the femoral artery will be accessed with the standard endovascular technique and the catheter will be advanced into the renal artery and connected to a radiofrequency generator. As in Simplicity HTN 1 and 2 trials, four-to-six discrete, low-power radiofrequency ablations lasting up to 2 min each and of 8 watts or less to obtain up to four-six ablations separated both longitudinally and rotationally within each renal artery. During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm.
16163831|NCT01673516|Device|The HOTMAN® System|"Impedance Cardiography by HOTMAN system will evaluates non-invasively hemodynamic parameters in patients randomized to group Co"
16163832|NCT01673503|Device|Carl Zeiss Meditech VisuMax laser|Refractive lenticule extraction (ReLEx) with the Carl Zeiss Meditech VisuMax laser
16163833|NCT01673490|Drug|Dutasteride/Tamsulosin|0.5 mg dutasteride/ 0.4 mg tamsulosin once daily for the duration of 180 day -treatment
16163834|NCT01673451|Drug|E2006|Part A: 2.5 mg, 5 mg, 10 mg, 25 mg, 50 mg, and 75 mg E2006 administered as capsules
16163835|NCT01673451|Drug|Placebo comparator|E2006-matched placebo (Part A and Part B); Part B: dose level to be determined based on results of Part A, administered as capsules
16163836|NCT01673438|Drug|aldoxorubicin|
16163837|NCT01673425|Drug|Live Attenuated Influenza Vaccine|All participants will be given FluMist.
16163838|NCT01673412|Other|Psychological tests|social and economical level intellectual quotient (Raven's Progressive Matrices Standard) Coopersmith self-esteem inventory BECK Depression inventory Minimal Mental Status
16163839|NCT01673399|Drug|Atosiban|Bolus atosiban 6.75mg + infusion atosiban 18mg/u during 3 hours. once administered starting 1 hour before embryotransfer.
16163840|NCT01673399|Drug|placebo|
16163841|NCT01673386|Drug|Tivozanib|
16163842|NCT01673386|Drug|Sunitinib|
16163843|NCT01673373|Device|iCAST™ Rx Stent System|All enrolled subjects will undergo primary stenting of the target lesion(s) by placement of the iCAST™ RX Stent System.
16163844|NCT01673360|Device|Elevate PC|List of AMS prolapse products
16163845|NCT01673360|Device|Mini Arc Pro|List of AMS Urinary Incontinence devices
16163846|NCT01673360|Device|RetroArc|List of AMS Urinary Incontinence devices
16163847|NCT01673347|Biological|Meniscal Allograft|Meniscal allograft
16163848|NCT01673334|Device|Fine Needle Aspiration (FNA) and Core biopsy (FNB)|
16163849|NCT01673321|Other|Dietary intervention|All snacks (arms) were randomly given to subjects to be consumed within 5 minutes, after 4 hours of consuming a standard breakfast.
16163850|NCT01673308|Drug|Lenalidomide|Lenalidomide 10 mg orally on days 1 to 21 of a 28-day cycle for at least 4 cycles until intolerance or disease progression.
16163851|NCT01673295|Drug|RTX infusions|RTX + Standard of Care
16163852|NCT01673295|Other|Standard of Care|Standard of Care only
16163853|NCT01673282|Drug|Lacosamide|Route of Administration: oral/subcutaneous Form and Dosage: Tablet (50 mg/100 mg/150 mg, 200 mg); Syrup (10 mg/ml); Solution for infusion (10 mg/ml).
16163854|NCT01673269|Other|Blood culture ( aerobic and anaerobic)|Blood culture 5 minutes and 30 minutes after the procedure
16163855|NCT01673256|Device|SJM Confirm ICM|
16163856|NCT01673243|Other|Questionnaire|Questionnaire data will be collected one time from parents who enroll on the study during their child's regular clinical visit. We will use a cross-sectional design to estimate the proportion of smoking parents of children with or surviving cancer, or sickle cell disease (SCD) who are willing to participate in tobacco trials, hypothetically offered in the context of their child's medical care. We will also examine the contribution of sociodemographic, environmental, and psychosocial variables, as well as, smoking behaviors as they relate to a parent's willingness to participate in a tobacco-related study.
16163857|NCT01673230|Procedure|cardiac surgery for ventricular dysfunction|For each included patient during the immediate post operative period, hemodynamic variables will be recorded (continuous arterial pressure, ECG, photoplethysmographic curve, CVP, wedge pressure, respiratory pressure), at rest (proclive 45°), during fluid expansion (physiological saline).
16163858|NCT01673217|Drug|decitabine|Given IV
16163859|NCT01673217|Biological|NY-ESO-1 peptide vaccine|Given SC
16163860|NCT01673217|Drug|pegylated liposomal doxorubicin hydrochloride|Given IV
16163861|NCT01673217|Biological|sargramostim|Given SC
16163862|NCT01673217|Biological|incomplete Freund's adjuvant|Given SC
16163863|NCT01673217|Other|immunohistochemistry staining method|Correlative studies
16163864|NCT01673217|Other|liquid chromatography|Correlative studies
16163865|NCT01673217|Other|mass spectrometry|Correlative studies
16163866|NCT01673217|Genetic|reverse transcriptase-polymerase chain reaction|Correlative studies
16163867|NCT01673217|Other|laboratory biomarker analysis|Correlative studies
16163868|NCT01673217|Genetic|DNA methylation analysis|Correlative studies
16163869|NCT01673217|Other|enzyme-linked immunosorbent assay|Correlative studies
16163870|NCT01673204|Drug|Calcitriol|dosage of 0.5mcg administered orally once daily for 12 month
16163871|NCT01673204|Drug|Placebo|
16163872|NCT01673191|Drug|Dexamethasone intravitreal implant|
16163873|NCT01673191|Drug|Steroid plus NSAID eye drop combination therapy|
16163874|NCT01673178|Other|Placebo|0.9% w/v sodium chloride injection, United States Pharmacopeia (USP), once a week for 4 weeks
16163875|NCT01673178|Drug|25 mg PF-05231023|25 mg IV once a week for 4 weeks
16163876|NCT01673178|Drug|50 mg PF-05231023|50 mg IV once a week for 4 weeks
16163877|NCT01673178|Drug|100 mg PF-05231023|100 mg IV once a week for 4 weeks
16163878|NCT01673178|Drug|150 mg PF-05231023|150 mg IV once a week for 4 weeks
16163879|NCT01673165|Other|Skimmed mother's milk|Fortified skimmed mother's milk will be given to the skimmed mother's milk group. The fortifier is a standard fortifier we use in our population
16163880|NCT01673165|Other|Specialized Formula|Infants will receive our standard of care - specialized formula
16163881|NCT01673152|Dietary Supplement|Oligofructose|Dosing: children aged 7 to 12 years: 8g/day, children aged 12 to18 years: 15g/day Duration: 12 weeks
16163882|NCT01673152|Dietary Supplement|Maltodextrin|Dosing: children aged 7 to 12 years: 4g/day, children aged 12 to18 years: 6g/day, Duration: 12 weeks
16163884|NCT01673139|Behavioral|Moderate exercise|Moderate exercise with pulse about 70% of max pulse; 3 times a week for 3 years.
16163885|NCT01673139|Behavioral|Control|Given information on recommendations for physical activity.
16163886|NCT01673126|Device|Anodal tDCS|patients received anodal tDCS (on PFDL cortex) during 20 minutes preceded and followed by a behavioral assessment (Coma Recovery Scale Revised)
16163887|NCT01673126|Device|sham tDCS|Patient received a sham tDCS (5sec of stimulation). The device runs during 20minutes and the anode was placed over the DLPF cortex. A behavioral assessment preceded and followed the stimulation.
16163888|NCT01673113|Device|Zeltiq CoolSculpting device|"This is an FDA approved cooling device used for non-invasive and selective reduction of fat around the flanks, an area commonly referred to as the love handles."
16163889|NCT01673100|Behavioral|Physical Activity Promotion Intervention|Subjects in the experimental group (Physical Activity Promotion Telehealth Intervention) will receive messages on the study cell phone - approximately 2 to 3 messages every day. Depending on the subject's responses to the questionnaires at baseline (stages and processes of change) they will be given tips to help them engage in physical activity (such as messages to increase their self-efficacy or confidence, walking with a friend or spouse, breaking up physical activity bouts into 10 minutes bouts, etc.) and also to help them keep the physical activity appropriate. Walking will be primarily the suggested mode of activity.
16163890|NCT01673087|Drug|Metyrapone|750 mcg, oral, administered twice, 3.5 hours apart
16163891|NCT01673087|Drug|Dexamethasone|"Administered twice:
~1.5 mg, oral, at 11 pm And 0.25 mg, oral, at bedtime at least one week before or after other administration."
16163892|NCT01673087|Drug|Cortrosyn|250 mcg, IV, bolus, in the afternoon.
16163893|NCT01673087|Drug|Corticorelin ovine triflutate|100 mcg, IV, over 30 seconds, in the afternoon.
16163894|NCT01673074|Drug|(PDT) Photodynamic therapy|photosensitizer
16163895|NCT01673061|Drug|Lidocaine|See associated Arm Description
16163896|NCT01673061|Drug|Vapocoolant|See associated Arm Description
16163897|NCT01673048|Procedure|3-Nail-ESIN in femoral shaft fractures|
16163898|NCT01673035|Behavioral|CBT, exposure and response prevention|This intervention entails different exercises aimed exposure to health anxiety stimuli.
16163899|NCT01673035|Behavioral|BSM, stress management and applied relaxation|BSM, this intervention comprises structured exercises aimed at reducing stress and controlling the anxiety response. One main component is applied relaxation.
16163900|NCT01673022|Drug|IC Green|IC Green
16163901|NCT01673009|Drug|Gleevec|Gleevec® will be dosed orally 440 mg/m^2/day (max 800 mg/day) for pediatric subjects and 800 mg/day for adult patients.
16163902|NCT01672996|Drug|Ioforminol 160 mgI/mL|Given as s single administration to the subject
16163903|NCT01672996|Drug|Ioforminol 200 mgI/mL|Given as a single administration to the subject
16163904|NCT01672996|Drug|Iopamidol 300 mgI/mL|Given as a single administration to the subject
16163905|NCT01672983|Drug|ABT-450/ritonavir, ABT-267|ABT-450 (tablet) dosed with ritonavir (capsule), and ABT-267 (tablet)
16163906|NCT01672957|Drug|Mycophenolate Mofetil|Protocol does not specify any regimen for treatment. The choice of treatment will be made prior to enrollment by the treating physician.
16163907|NCT01672957|Drug|Immunosuppressive Therapy|Protocol does not specify any particular immunosuppressive drug and regimen for treatment. The choice of immunosuppressive therapy will be made prior to enrollment by the treating physician.
16163908|NCT01672944|Other|TBCCN-developed educational materials|Participants will be asked to view the educational materials developed by TBCCN, in either English or Spanish depending on the RCT in which they are enrolled. These materials include a DVD and a booklet that were developed to enhance community members' understanding and awareness of biospecimen collection and biobanking from healthy individuals.
16163909|NCT01672944|Other|NCI-developed educational materials|"Participants will be asked to view the English biobanking educational Brochure entitled Providing your Tissue for Research: What you need to Know, or Spanish brochure entitled Lo que usted debe saber antes de dar sus tejidos para investigación médica."
16163910|NCT01672931|Other|Oocyte Measurement|
16163911|NCT01672905|Other|laboratory biomarker analysis|
16163912|NCT01672892|Radiation|Standard radiation therapy|Patients treated once a day, 5 days a week with a daily fraction size of 1.8 Gy. Whole pelvis treated with a four-field technique (AP/PA/R lateral/L lateral) to 45 or 50.4 Gy at 1.8 Gy/fraction. The dose is prescribed to the isocenter which is defined as the intersection of the four beams and can be normalized to an isodose line between 97-100%. The decision to deliver 45 or 50.4 Gy is at the physician's discretion and must be reported at the time of enrollment.
16163913|NCT01672892|Radiation|intensity-modulated radiation therapy|Patients treated once a day, 5 days a week with a daily fraction size of 1.8 Gy. All targets treated simultaneously. The vaginal planning target volume (PTV) (ITV with 7.0 mm margin) and nodal PTV receives 45 Gy in 25 fractions or 50.4 Gy in 28 fractions. The decision to deliver 45 or 50.4 Gy is at the physician's discretion and must be reported at the time of enrollment.
16163914|NCT01672879|Biological|Placebo|Placebo to match SIM intravenous infusion over 30 minutes every 2 weeks
16163915|NCT01672879|Biological|SIM|Intravenous infusion over 30 minutes every 2 weeks
16163916|NCT01672866|Biological|Placebo|Placebo to match SIM via subcutaneous injection every week
16163917|NCT01672866|Biological|SIM|Subcutaneous injection every week
16163918|NCT01672853|Biological|Simtuzumab|Subcutaneous injections weekly for a total of 96 injections
16163919|NCT01672853|Biological|Placebo|Subcutaneous injections weekly for a total of 96 injections
16163920|NCT01672840|Dietary Supplement|5g Cocoa Consumption|Daily consumption of 10g Extra Dark cholocate and a beverage containing 2.5g of cocoa powder for 8 weeks
16163921|NCT01672840|Dietary Supplement|10g Cocoa Consumption|Daily consumption of 20g Extra Dark cholocate and two beverage containing 2.5g of cocoa powder each for 8 weeks
16163922|NCT01672827|Drug|[18F]Flutemetamol|No drug is administered in this intervention. These are scanned images being reviewed, previously acquired in various GE-067 studies.
16163923|NCT01672814|Drug|riboflavin ophthalmic solution|Administration of riboflavin every 2 minutes for 20 minutes
16163924|NCT01672814|Device|Vedera KXS Microwave System|The Vedera KXS dose will be based on the pre-treatment manifest refraction spherical equivalent (MRSE), to be administered one day prior to the CXL procedure.
16163927|NCT01672788|Drug|Empagliflozin|empagliflozin tablets and metformin tablet
16163928|NCT01672788|Drug|Empagliflozin + Metformin|fixed dose combination tablet (low)
16163929|NCT01672788|Drug|Metformin|empagliflozin tablets and metformin tablet
16163930|NCT01672788|Drug|Metformin|empagliflozin tablet and metformin tablet
16163931|NCT01672788|Drug|Empagliflozin + Metformin|fixed dose combination tablet (low)
16163932|NCT01672788|Drug|Empagliflozin|empagliflozin tablet and metformin tablet
16163933|NCT01672775|Drug|AGS-16C3F|intravenous (IV) infusion
16163934|NCT01672762|Drug|ipragliflozin|oral
16163935|NCT01672749|Device|Growth guiding construct using TROLLEY system|Growth guiding construct using the DePuy Synthes TROLLEY Gliding Vehicles (GVs)
16163936|NCT01672749|Device|Spine based dual growing rod or rib based VEPTR|spine based dual growing rod or the rib based Vertical Expandable Prosthetic Titanium Rib (VEPTR, Synthes North America)
16163937|NCT01672736|Drug|ASP7487, Velcade, Dexamethasone|ASP7487- Oral (75, 100, 150 mg)BID Bortezomib- 1.3 mg/m2 IV on days 1, 4, 8, 15 of each 21 day cycle up to cycle 8 and days 1, 5, 15, 22 of each 35 day cycle beyond cycle 9 Dexamethasone- 20 mg on the day of Bortezomib administration
16163938|NCT01672723|Drug|Naltrexone|
16163939|NCT01672710|Drug|plain crystalline niacin, exercise, sauna|A four to six week regimen consisting of daily, supervised, mild-moderate exercise as tolerated for 20 minutes, supervised, intermittent Finnish saunas (at about 140'F) sauna time with breaks and showers, gradually increased as tolerated to approximately 4 hours, dietary supplements including immediate release niacin in gradually increasing doses from 100 mg to a maximum of 5000 mg per day, salt and water, other vitamins, minerals and oils per Hubbard protocol.
16163940|NCT01672697|Behavioral|Physical Therapy (PT) and Behavioral Therapy (BT)|"Physical Therapy (PT) Protocol states that each participant in the treatment arm only will undergo a total of four 45-minute sessions with a certified pelvic floor (PF) physical therapist over the course of the 12 weeks. Routine monitoring of patient progress will be performed. Each session includes using the body core muscles and internal pelvic floor muscles, focusing on PF protection techniques, PF exercises, Core exercises, progression to full ADLs(activities of daily living), and an exercise routine.
~Behavioral Therapy (BT) Instructions are given only to participants in the treatment arm after randomization at week-2 visit; handout provides specific instructions about appropriate diet, hygiene and level of activity during the 12 weeks of enrollment."
16163941|NCT01672684|Procedure|support group therapy|Complete at-home group video calling support sessions
16163942|NCT01672684|Other|educational intervention|Receive an educational workbook journal
16163943|NCT01672671|Drug|Doxorubicin, Paclitaxel, Cisplatin|Doxorubicin 25 mg/m2, IV weekly. Number of Cycles: 8 Paclitaxel 100 mg/m2, IV weekly. Number of Cycles: 8. Cisplatin 30 mg/m2, IV weekly. Number of Cycles: 8.
16163944|NCT01672658|Device|Sensory Kinetics Balance System|Subjects will participate in balance/gait/functional mobility training twice a week for 8 weeks.
16163945|NCT01672658|Other|Traditional Vestibular Rehabilitation|Subjects will perform traditional vestibular/balance rehabilitation which will include gait training, balance retraining, vestibular retraining, and functional mobility.
16163946|NCT01672645|Biological|NIC7-001|Intramuscular, multiple dose
16163947|NCT01672645|Biological|NIC7-003|Intramuscular, multiple dose
16163948|NCT01672645|Biological|Saline|Saline (0.9% sodium chloride)
16163949|NCT01672632|Other|Overfeeding|We overfed 40 young, healthy adults by 40% of their baseline energy requirements for 8 weeks. The diet consisted of 41% carbohydrate, 44% fat, and 15% protein.
16163950|NCT01672619|Procedure|dynamic craniotomy|Surgical technique of craniotomy spiral without detachment of dura mater
16163951|NCT01672606|Drug|Rocuronium|Partial neuromuscular blockade with rocuronium with a TOF 0.70
16163952|NCT01672593|Procedure|Endoscopy exploration and glue application|A forward-viewing fistula-fiberscope (EndoView, Outai Medical Equipment, Shanghai, China), with 15cm length and 5mm width of fiber optical wire, was inserted into the fistula tract to accomplish endoscopic visualization. Briefly, the fistula-fiberscope assisted procedure was carried out percutaneously, allowing the exposure of internal hole and the whole tracts, followed by insertion of this catheter with distal mixing device. Upon injection, two components, fibrinogen and thrombin, were mixed together in the mixing reservoir and yield a gelatin-like glue. This procedure was repeated in patients up to 3 times within 14-day FG treatment period.
16163953|NCT01672593|Drug|Anti-Bacterial Agents|Antibacterial therapy was given to patients with signs of systemic sepsis or local inflammation with pain.
16163954|NCT01672593|Dietary Supplement|Nutrition support|Nutritional replacement and bowel rest via enteral or parenteral nutrition.
16163955|NCT01672593|Procedure|PRFG preparation|As described in our previous work, platelet-rich cryoprecipitate and thrombin were obtained from 300-400ml whole blood of each patient enrolled in the PRFG group and then frozen at -20°C for storage.
16163956|NCT01672580|Behavioral|exposure to vitamin use|"Seed individuals in village are given daily adult multivitamin, with training on use and general nutrition information, along with coupons to distribute to others in village"
16163957|NCT01672580|Behavioral|exposure to water chlorination|"Seed individuals in village are given Clorox bleach for water purification, with training on use and general information on water hygiene, along with coupons to distribute to others in village"
16163958|NCT01672580|Behavioral|high in-degree|"Seed individuals for starting intervention are chosen on the basis of high (social network) in-degree"
16163959|NCT01672580|Behavioral|nominated by random|"Seed individuals for starting intervention are chosen on the basis of being named as a friend/alter of a randomly selected individual"
16163960|NCT01672567|Dietary Supplement|Egg supplementation|Daily consumption of 2 eggs for breakfast for 6 weeks
16163961|NCT01672567|Dietary Supplement|Egg substitute|Daily consumption of 1/2 cup of Egg Beater for breakfast for 6 weeks
16163962|NCT01672567|Dietary Supplement|Control diet|Daily consumption of high carbohydrate breakfast diet for 6 weeks, consisting of any of the following choices during each day of the treatment period: bagel, waffles, pancakes, or cereal and milk
16163989|NCT01672333|Drug|TOX|oxaliplatin 100mg/m2 IV over 2 hours at 1st day docetaxel 50 mg/m2 IV over 1 hour at 1st day capecitabine 625 mg/m2 PO for 14 days
16163990|NCT01672307|Drug|Minoxidil lotion 2%|Minoxidil lotion 2% is applied twice daily to one eyebrow.
16163991|NCT01672307|Drug|Placebo|Placebo is applied twice daily to the other eyebrow.
16163963|NCT01672554|Drug|Quetiapine XR|Quetiapine XR will be titrated according to the following pattern: Seroquel XR 300 mg on day 1 and Seroquel XR 600 mg on day 2. On day 3, the dosage could be either maintained at 600 mg/day or continued up to 800 mg/day or if the 600 mg dose is not tolerated, the dose could then be reduced to 400 mg/day. Following this, subjects will be flexibly dosed, according to clinical judgment of the investigator, between 400 mg/day and 800 mg/day with minimum dose adjustments of 200 mg/day. This adjustment can be performed at anytime during the study but should not take place within a week from last cognitive assessment, planned at month 6. An overlap of at least 4 days but not more than 2 weeks with the previous antipsychotic will be allowed with decreasing doses on a two-week period.
16163964|NCT01672541|Behavioral|Dating Matters Comprehensive Approach|"The Dating Matters Comprehensive Approach includes:
~6th, 7th, and 8th grade Student Curricula; Parent Programs for parents of 6th, 7th, and 8th graders; A communications campaign involving brand ambassadors, a text message campaign, and social media campaign; An online training about teen dating violence for educators; Developmental component: A guidance document for sites on assessing and informing local policies relevant to teen dating violence for comprehensive schools (likely to be substantial cross and within site variation on this component)"
16163965|NCT01672541|Behavioral|Standard of Care Safe Dates Approach|Safe Dates curriculum for 8th grade students
16163966|NCT01672528|Other|Interview|Patient participates in a face-to-face interview to facilitate development of the new disease specific questionnaire
16163967|NCT01672528|Other|Questionnaires|Patients will be sent questionnaires before their procedure, 8 - 12 after their procedure and at 1 and 5 years post procedure
16163968|NCT01672515|Device|RIPC group|
16163969|NCT01672515|Device|Control group|
16163970|NCT01672502|Behavioral|Sleep health education provided via a web-based program|All firefighters in the experimental group and controls will be asked to complete an approximately 30 minute education session. This education session will split into two modules, module 1: an introduction to the program along with basic sleeps hygiene information and module 2: standard training. Topics covered in module 2 will include basic sleep physiology, the causes and consequences of sleep disorders, and fatigue countermeasures. We will emphasize strategies to maximize sleep and reduce fatigue both on and off work.
16163971|NCT01672502|Other|Sleep disorder detection and treatment|Firefighters in the intervention districts will complete a sleep disorders screening questionnaire. The questionnaire will focus on identifying individuals who show increased likelihood of suffering from obstructive sleep apnea, insomnia, shift work disorder, and restless legs syndrome using validated screening tools. Those assessed to be at high risk for one of these sleep disorders will be referred to a local AASM-accredited Clinical Sleep Disorders Service for evaluation and, if necessary, treatment. Diagnosis and treatment of sleep-related disorders will reduce the risk of fatigue-related accidents and improve the health and safety of affected individuals.
16163972|NCT01672502|Other|Optimization of Sleep in Fire Station|First, we will review and retrofit the sleeping quarters to provide a better environment for napping and sleep; light, noise, bed type, space, temperature, and location would all be considered and where possible, changes made to improve the sleeping environment. Secondly, we will work with management and union personnel to develop a 'sleep friendly' policy during the daytime, with specified protected times for naps during the day before the overnight work in order to reduce sleepiness during overnight work. Finally, we will upgrade the alerting systems, that is, we will work with management and union personnel to consider changing the policy that requires the sleeping areas of all stations to receive all alarm calls, even if that particular station is not required to attend the alarm.
16163973|NCT01672476|Drug|Placebo|Placebo
16163974|NCT01672476|Drug|Valsartan|Valsartan 80mg
16163975|NCT01672476|Drug|Fimasartan|Fimasartan 30mg
16163976|NCT01672463|Drug|OKN-007|"Dose escalation/PK cohort: 20 mg/kg, 40 mg/kg or 60 mg/kg OKN-007 via IV infusion, given 3x/week for the first 4 weeks, then 2x/week for the next 4 weeks, then 1x/week thereafter.
~Expansion cohort: MTD via IV infusion given 3x/week for the first 4 weeks, then 2x/week for the next 4 weeks, then 1x/week thereafter."
16163977|NCT01672450|Drug|Intratumoral Ipilimumab and Interleukin-2|Only 1 lesion, 0.5 -2 cm, will be treated. Interleukin-2, 3 mIU IT TIW x 2 weeks (days 1, 3 and 5), then BIW x 6 weeks (days 1 and 4). Escalating doses of Ipilimumab (0.1, 0.25, 0.5, 1, 2, mg) IT weekly x 8 weeks
16163978|NCT01672437|Other|Birth and parent preparation|4 sessions of birth and parent preparation in small groups of 6-8 couples. 3 sessions during pregnancy, 1 session following birth.
16163979|NCT01672424|Other|Ice Chips|11 ounces of ice chips given to the laboring parturient
16163980|NCT01672424|Other|Protein Drink|Patients will receive 11 ounces of a protein shake which contains 30 grams of protein
16163981|NCT01672398|Other|Telemonitoring plus self-management support|Patients in the intervention group receive automated telephone calls that ask about their health and self-care along with tailored health-related feedback. The patient's CarePartner receives health update reports about the patient and how they can help via e-mail. Urgent health problems are reported to the patient's health care team via fax or e-mail.
16163982|NCT01672385|Other|Telemonitoring plus self-management support|Patients in the intervention group receive automated telephone calls that ask about their health and self-care along with tailored health-related feedback. The patient's CarePartner receives health update reports about the patient and how they can help via e-mail. Urgent health problems are reported to the patient's health care team via fax or e-mail.
16163983|NCT01672372|Dietary Supplement|Max Stress B|Participants are to mix one vial per day of either placebo or actual supplement in 1 liter of water and drink over the course of the day
16163984|NCT01672372|Dietary Supplement|Placebo Max Stress B|
16163985|NCT01672359|Dietary Supplement|Ginkgo Synergy® and Choline|3 tablets 2 times per day with breakfast and dinner over 6 months
16163986|NCT01672359|Dietary Supplement|OPC Synergy® and Catalyn|3 tablets 2 times per day with breakfast and dinner over 6 months
16163987|NCT01672359|Dietary Supplement|Placebo|
16163988|NCT01672346|Procedure|PVAI followed by adenosine provocation|All patients will undergo PVAI and ablation of the posterior wall of the LA using an open-irrigated ablation catheter and under general anesthesia. After PV isolation is achieved, all will undergo PVAI followed by adenosine provocation test with 24 mg of adenosine to check for PV reconnection. Upon identification, additional RF energy would be used to ablate those sites (that were revealed by adenosine-provocation).
16164423|NCT01668667|Drug|GSK1838262 450 mg|Drug: GSK1838262 450 mg/day Comparison of 3 doses
16163992|NCT01672294|Other|Preparation and life completion|Caregiver subjects will discuss life review, issues of forgiveness and heritage and legacy.
16163993|NCT01672294|Other|Attention Control|Caregiver subjects will listen to a non-guided relaxation CD with facilitator.
16163994|NCT01672281|Other|vibrox- vs. resistance training|Comparison between two exercise interventions
16163995|NCT01672268|Other|cardiac computed tomography|cardiac computed tomography, Transcatheter Aortic Valve Implantation, safety and efficacy
16163996|NCT01672255|Drug|Fluoxetine|20 mg week 1, 40 mg week 2, 60 mg week 3, 80 mg week 4-6
16163997|NCT01672255|Drug|Placebo control|20 mg Week 1, 40 mg Week 2, 60 mg Week 3, 80 mg Week 4-6
16163998|NCT01672242|Device|HFNC|Graded high flow nasal cannula oxygen at 10, 20 , 30, and 40 liters per minute (LPM) to each subject and end-expiratory lung volume measured by respiratory inductive plethysmography.
16163999|NCT01672242|Device|CPAP|Graded contiuous positive airway pressure at 5, 10 , 15, and 20 cm H2O applied to each subject and end-expiratory lung volume measured by respiratory inductive plethysmography.
16164000|NCT01672229|Drug|Bortezomib|If improvements are seen at any dose level and patients have no DLTs, they will stay at their dose level until the end of the study. This is to avoid any possible toxicity while the patient is benefiting from their current dosing of bortezomib. If the continuous improvement in GVHD stalls at any point, or the GVHD progresses after the original improvement, while the dose level is maintained, then the dose will be increased to the next dose level. Patients will remain enrolled until exacerbation of the GVHD on increasing dose schedule or closure of the study. Clinical activity will be monitored every other week after the initiation of bortezomib until the study closes.
16164001|NCT01672216|Device|Combination of EMG-biofeedback plus EMG-triggered AM-MF-stimulation|
16164002|NCT01672216|Device|EMG-biofeedback alone|
16164003|NCT01672190|Other|Yoga Therapy Program|
16164004|NCT01672177|Behavioral|Chronic disease self-management training|Those in the intervention group will receive two hour long weekly training sessions for seven-eight months (a total of 56 hours of training).
16164005|NCT01672151|Drug|rapamycin|4mg oral administration on the first day, 2 mg/d oral administration for 3 months
16164006|NCT01672138|Procedure|Pulmonary Vein Antrum Isolation|Radio-frequency catheter ablation of pulmonary vein antrum extended to the left atrial posterior wall
16164007|NCT01672138|Procedure|scar homogenization|PVAI + RF energy will be delivered until all abnormal potentials in the low-voltage areas are eliminated.
16164008|NCT01672138|Procedure|Non-PV triggers ablation|PVAI + Isolation of LA posterior wall + Catheter ablation of triggers originating from extra-PV sites
16164009|NCT01672125|Other|circumferential measurements in different upper limb positions.|circumferential measurements in different upper limb positions, in 90 degrees forward flexion and depending position
16164010|NCT01672112|Drug|Oxycodone|Oral Oxycodone 5mg 6hrly/prn
16164011|NCT01672112|Drug|Codeine|Oral Codeine 60mg 6hrly/prn
16164012|NCT01672099|Dietary Supplement|nutrient enriched product|The intervention in this study consists of the consumption of two nutrient enriched yoghurt products. The participants consume the study products twice a day during 12 weeks, one yoghurt product (250 ml) during breakfast and one yoghurt product (250 ml) during dinner.
16164013|NCT01672099|Dietary Supplement|basic dairy product|The intervention in this study consists of the consumption of two basic yoghurt products. The participants consume the basic yoghurt products twice a day during 12 weeks, one yoghurt product (250 ml) during breakfast and one yoghurt product (250 ml) during dinner.
16164014|NCT01672086|Device|Stelkast Surpass Acetabular System implant|
16164015|NCT01672060|Behavioral|Nurse-Family Partnership (NFP)|Trained Public Health Nurses (PHNs) will deliver Nurse-Family Partnership (NFP) using specified pregnancy, infancy and toddler curricula. Following enrollment in the study, NFP PHNs will provide regular home visits to participants throughout the remainder of the participant's pregnancy, continuing through until the child's second birthday. In addition to offering standard care during each visit, PHNs will deliver NFP content using program materials relevant to the following domains: personal health, maternal role, environmental health, family and friends, life course development, and health and human services.
16164016|NCT01672060|Behavioral|Existing services|Participants allocated to the comparison group will receive all the usual perinatal programs and services offered within their Health Authority, including primary care and specialist physician services covered under BC's public healthcare system. These services vary across the province but may include: standard primary healthcare services; public health programs including prenatal classes, pregnancy outreach and home visiting by nurses or paraprofessionals; and a variety of targeted and universal parenting and early child development programs.
16164017|NCT01672047|Drug|Vitamin D2|25（OH）D level <12 nmol/L 50000IU/weekX12week， 12-39 nmol/L 50000IU/weekX4week then，50000IU/month， 40-75 nmol/L 50000IU/month， 75-116.75nmol/L 25000IU/month， >116.75nmol/L stopped.
16164018|NCT01672034|Procedure|Laparoscopic gastric bypass surgery|
16164019|NCT01672021|Procedure|PET/MRI|PET/MRI
16164020|NCT01672008|Drug|NOX-100|
16164021|NCT01671995|Procedure|Nurse monitored heart failure program|Standard program for a heart failure clinic with information, education, drug titration
16164022|NCT01671995|Procedure|Standard primary health care|Standard care in primary care according to national guidelines but at the discretion of the primary care caregiver
16164023|NCT01671982|Other|Tenofovir Dose Adjustment|In subjects with a confirmed CLcr 30 to <50 mL/min, switch tenofovir 300 mg every 48 hours, to 150 mg once daily for 2 weeks.
16164024|NCT01671969|Other|very low calorie diet|medically supervised diet
16164025|NCT01671956|Biological|Bertilimumab|IV infusion over 30 minutes, at Day 0, Day 14 and Day 28
16164026|NCT01671956|Biological|Placebo|IV infusion over 30 minutes, at Day 0, Day 14 and Day 28
16164027|NCT01671943|Device|Ice-Sense3TM|Ice-Sense Cryoprobe
16164028|NCT01671917|Other|Educational and exercise program|"4 (twice a week) group education sessions lasting 30 minutes plus an education booklet about knee replacement
~4 (twice a week) sessions of an exercise programme lasting 1 hour"
16164029|NCT01671917|Other|Usual care|Information and counseling usually provided in orthopedics department and an information booklet about knee replacement.
16164030|NCT01671904|Drug|Bendamustine|Participants will receive intravenous (IV) infusion of bendamustine (90 or 70 milligrams per square meter [mg/m^2]) on Days 2-3 of Cycle 1 and Days 1-2 of Cycles 2-6.
16164031|NCT01671904|Drug|Obinutuzumab|Participants will receive IV infusion of obinutuzumab (100 milligrams [mg]) on Day 1 of Cycle 1; 900 mg administered on Day 2 of Cycle 1; and 1000 mg administered on Days 8 and 15 of Cycle 1 and on Day 1 of Cycles 2-6.
16164032|NCT01671904|Drug|Rituximab|Participants will receive IV infusion of rituximab (375 mg/m^2) on Day 1 of Cycle 1 and 500 mg/m^2 administered on Day 1 of Cycles 2-6.
16164033|NCT01671904|Drug|Venetoclax|Participants will receive multiple doses of venetoclax orally once daily.
16164034|NCT01671891|Radiation|radiation therapy|45-55Gy
16164035|NCT01671891|Drug|capecitabine (625mg/m2,bid,d1-5 qw)and oxaliplatin (85mg/m2 d1 qw)|radiotherapy concurrent chemotherapy(capecitabine+oxaliplatin)
16164036|NCT01671878|Other|Reference Glucose|
16164037|NCT01671878|Other|Test Food 1 (Cereal)|
16164038|NCT01671878|Other|Test Food 2 (Biscuit)|
16164039|NCT01671852|Drug|Mometasone furoate nasal spray|"Included patients will be randomized to a sequence of treatments including a medicated nasal spray and a saline nasal spray. The medicated group will receive Mometasone nasal sprays at the dosage outlined below for 8 weeks. The placebo group will receive saline nasal sprays for an equal duration. Informed consent of the parents or legal guardians will be obtained.
~For patients that are between age 3 to 11 years and if they are randomized to the medicated group, they will use pediatric dosing of Mometasone nasal sprays, 1 spray (50 mcg) in each nostril once daily for 8 weeks. For patients that are older than age 12 and if they are randomized to the medicated group, they will use adult dosing of Mometasone nasal sprays, 2 sprays (100mcg) in each nostril twice daily for 8 weeks."
16164040|NCT01671852|Drug|Placebo|
16164041|NCT01671839|Device|Subcutaneous tissue release with the Cabochon System|Device: Subcutaneous tissue release
16164042|NCT01671813|Drug|brentuximab vedotin|Brentuximab vedotin will be given intravenously as outlined in treatment arm.
16164043|NCT01671800|Drug|Botulinum Type B|
16164044|NCT01671800|Drug|Placebo|
16164045|NCT01671787|Drug|GS-7340|Subjects are randomized to receive one of four different doses of GS-7340 over 28 days of therapy.
16164046|NCT01671787|Drug|Tenofovir disoproxil fumarate|Subjects will receive 300mg of Tenofovir disoproxil fumarate (TDF) over 28 days of therapy
16164047|NCT01671774|Drug|IMAB362|800 mg/m2 on d 1 of cycle 1. 600 mg/m2 on d 1 of every other cycle
16164048|NCT01671774|Drug|Zoledronic acid|4 mg on d 1 of cycle 1 and cycle 3
16164049|NCT01671774|Drug|Interleukin-2 (1 million IU)|1 million IU on day 1, 2 and 3 of cycles 1 and 3.
16164050|NCT01671774|Drug|Interleukin-2 (3 million IU)|3 million IU on day 1, 2 and 3 of cycles 1 and 3.
16164051|NCT01671748|Device|MIST ultrasound therapy|Low frequency, non-contact ultrasound system delivering therapeutic ultrasound via a fine saline mist to the wound bed.
16164052|NCT01671748|Other|Standard Care|Compression bandaging, non-adherent dressing, and debridement if required.
16164053|NCT01671735|Other|Survey|A clinical demonstration project funded by NCP will involve screening Veterans and enrolling veterans with pre-diabetes into the VA DPP program. This research project will recruit VA DPP eligible participants enrolled in the VA DPP program and Veterans enrolled in MOVE! that are VA DPP eligible as a comparison group. The research is not truly an intervention but similar to a program evaluation.
16164054|NCT01671722|Drug|Montelukast sodium|Montelukast sodium tablets 10mg
16164055|NCT01671709|Drug|Montelukast sodium|Montelukast sodium tablets 10mg
16164056|NCT01671696|Other|Cardiac MRI|Cardiac MRI
16164057|NCT01671670|Other|acupuncture|In this group, acupuncture is given according to traditional acupuncture theories.
16164058|NCT01671670|Other|sham acupuncture|Sham acupuncture points will be used in this trial, with needle penetration.
16164059|NCT01671631|Other|Measurement of intracoronary pressure|
16164060|NCT01671592|Biological|DC Vaccine|Alpha-type-1-polarized dendritic cells (αDC1) pulsed with apoptotic autologous tumor.
16164061|NCT01671579|Procedure|Bowel ultrasound|The ultrasound imaging will take place prior to the clinically ordered MRE exam. The subject will be asked to lie on the ultrasound table for approximately 60 minutes while a variety of ultrasound images are completed.
16164062|NCT01671579|Procedure|magnetic resonance enterography (MRE)|The subject will have a small intravenous (IV) catheter placed in on of their arms before the MRE exam. Medications called Glucagon and MultiHance will be given thru the IV catheter during the imaging study. The glucagon will decrease the movement of the intestines, which helps provide better images of the bowel. MultiHance is a contrast that helps create clearer MRE images. In addition to the MultiHance, the subject will be given an oral contrast medication called VoLumen to drink approximately 45 minutes before the MRE imaging is started. These medications are used for all clinically necessary MRE studies performed in children and adults at the UMHS. The MRE will take approximately 50 to 60 minutes to complete.
16164063|NCT01671566|Behavioral|Home based interval training|The participant in the intervention group will receive an individualized interval training program. The individualized adjustments in training load will be made from the results of the CPET-incremental and adjustments in training time from the results of the constant work rate 75% of peak work rate (Watt). The training will be home based and performed on a ergometer cycle 3 times a week for twelve weeks. During exercise they will wear a heart rate monitoring watch. The registered heart rate will be transferred to a webpage after the exercise session. Only the physiotherapist and participant have the access to this page. The physiotherapist and participant will have a weekly contact to promote compliance, provide feedback and if necessary adjust the training time or load. Progression in training load and time will be made when necessary to keep a relevant intensity.
16164064|NCT01671553|Behavioral|Counseling group|The content for the brief counseling group adopts a AWARD approach including asking the smoking habit, warning about the health risks associated with smoking, advising the smokers to quit, referring to specialized service, and repeating the above message. Additional telephone follow-up counseling at 1, 2, 3 and 8-week will be made to the participants in this group.
16164065|NCT01671540|Device|intrapulmonary percussive ventilation|
16164066|NCT01671540|Other|standard treatment|breathing control exercises
16164144|NCT01670864|Behavioral|SMS intervention group|The text messages are divided into two groups which target to smokers who are ready to quit and those who are not ready to quit. For smokers who are ready to quit, messages would be focused on practical advice and emotional support. For smokers who are not ready to quit, messages would be focused on motivating the smokers to have quit attempt.
16264729|NCT00901979|Drug|metformin|
16164067|NCT01671527|Procedure|Transcranial magnetic stimulation (TMS)|We will test the sensory system and its interaction with the motor cortex by using TMS. For these tests, you will sit in a chair that looks like one you would find at the dentist's office. A nerve stimulator will be placed on the wrist of your right hand to stimulate the median and ulnar nerves. The intensity of the nerve stimulator will be gradually increased until the right thumb begins to twitch. A magnetic coil will be placed on the scalp on the left side of your head, overlying the brain's motor cortex, to stimulate the brain's output to the muscles in the opposite hand. This procedure will be repeated using the left wrist and the right side of your head.
16164068|NCT01671514|Dietary Supplement|Epicatechin-enriched dark chocolate|For experimental purposes, subjects will take one square of epicatechin-enriched dark chocolate per day for 90 days.
16164069|NCT01671514|Other|Low-epicatechin dark chocolate|As a placebo control, subjects will take 1 square of low-epicatechin chocolate per day for 90 days.
16164070|NCT01671501|Behavioral|Motivational Interviewing|
16164071|NCT01671501|Behavioral|Email Feedback|
16164072|NCT01671501|Other|Usual Care|
16164073|NCT01671488|Biological|Treatment|ADXS11-001 will be given at a dose of 1x109 cfu intravenously once every 28 days for 4 total doses. All 4 doses of ADXS11-001 will be 1x109 cfu.
16164074|NCT01671488|Drug|5FU|1 gm/m2/day x 96 hours beginning on day 1-4 and day 29-32 + 7 days
16164075|NCT01671488|Drug|Mitomycin|10 mg/m2, day 1 and 29 (day 29 can be + 7 days)
16164076|NCT01671488|Radiation|IMRT|54 Gy in 30 fractions at 1.8 Gy per fraction.
16164077|NCT01671475|Device|microEEG (Bio-Signal microEEG)|"At the core, the Bio-Signal microEEG, is an FDA approved miniature, battery-operated, multi-channel, and portable system that records wideband bioelectric signals. The microEEG combines the characteristics of low noise and small size, due to a number of fundamental design characteristics. It records, amplifies, and digitizes the signals at a point very close to the electrodes. This allows the length of the wires between electrodes and the recorder's amplifiers to be very short, keeping them out of the way. Short wires also reduce any inconvenience signal artifacts or other problems that may be associated with the length of the wires. The microEEG's dimensions are about 2x2x1."
16164078|NCT01671462|Device|BD HPV assay on Viper LT|
16164079|NCT01671449|Drug|S-1|S-1 : 40 mg/m2, twice daily, Day 1-14
16164080|NCT01671449|Drug|Cisplatin|60 mg/m2/day Day 1
16164081|NCT01671449|Drug|Oxaliplatin|130 mg/m2/day Day 1
16164082|NCT01671436|Behavioral|Central Meditation and Imagery Therapy|
16164083|NCT01671423|Drug|Prednisone|"See Prednisone arm description"
16164084|NCT01671423|Drug|Placebo|"See Placebo arm description"
16164085|NCT01671410|Drug|oral morphine|Oral morphine for the treatment of neonatal abstinence syndrome
16164086|NCT01671410|Drug|sublingual buprenorphine|Sublingual buprenorphine for the treatment of neonatal abstinence syndrome
16164087|NCT01671397|Behavioral|Diet and exercise counseling|Not needed
16164088|NCT01671397|Behavioral|Diet, exercise, sleep hygiene counseling|None needed
16164089|NCT01671384|Drug|Valproate, Levocarnitine|"All patients with diagnosis of SMA aged 2-15 years already registered in Myopathy Clinic of AIIMS will be recalled. Information will be sent to all Government Hospitals in Delhi that such a study is currently in progress and all the referrals will also be recruited. These patients and all those newly diagnosed at Myopathy Clinic, AIIMS will be randomized into two groups:
~Group I (Physiotherapy + Placebos) Group II (Physiotherapy + Valproate and Levocarnitine)
~The investigators will be blinded to the code of the medicine. It will be broken only at the end of the study or if there are any significant side effects. So one group will receive Valproate and levocarnitine and other group will receive Placebo and placebo."
16164090|NCT01671384|Drug|Placebo|"All patients with diagnosis of SMA aged 2-15 years already registered in Myopathy Clinic of AIIMS will be recalled. Information will be sent to all Government Hospitals in Delhi that such a study is currently in progress and all the referrals will also be recruited. These patients and all those newly diagnosed at Myopathy Clinic, AIIMS will be randomized into two groups:
~Group I (Physiotherapy + Placebos) Group II (Physiotherapy + Valproate and Levocarnitine)
~The investigators will be blinded to the code of the medicine. It will be broken only at the end of the study or if there are any significant side effects. So one group will receive Valproate and levocarnitine and other group will receive Placebo and placebo."
16164091|NCT01671371|Other|Point-of-Care Ultrasound|Performance of a focused cardiac ultrasound including a qualitative assessment of left ventricular function, pericardial effusion, right ventricular strain, proximal ascending aortic diameter, and inferior vena cava size and collapsibility
16164092|NCT01671345|Behavioral|Intervention Video|A video intervention delivered prior to patients' visits with primary care physicians designed to increase use of active participatory communication (patient participation) behaviors, improved communication ratings, and improved medication adherence
16164093|NCT01671345|Behavioral|Control|Attention control
16164094|NCT01671332|Drug|Docetaxel|IV over 60 minutes, 75 mg/m2
16164095|NCT01671332|Drug|Suramin|IV over 30 minutes
16164096|NCT01671332|Drug|Docetaxel|IV over 60 minutes. 56 mg/m2
16164097|NCT01671319|Drug|docetaxel + cyclophosphamide + pegfilgrastim|docetaxel 75 mg/m2 + cyclophosphamide 600 mg/m2 IV every 2 weeks x 4 cycles plus pegfilgrastim 6mg sq 24-48 hours post day 1 of each cycle
16164098|NCT01671293|Behavioral|Multicomponent remote care model|A remote intervention based on counseling (telephone-based) was implemented. This counseling intervention is the core of the multi-component model, which also includes counseling through text messages, the purveyance of educational material, and self-monitoring equipment (pedometer & waist circumference measuring tape). The phone counseling is made by health centers professionals who have been trained to apply theories on behavioral change and decision-making. Phone counseling is conducted at least once a month. Messages are sent weekly and are related to the topics referred to in phone counseling sessions. The educational material and equipment -respectively- seek to provide additional information and foster the habit of self-monitoring progress and/or reversions in the change process.
16164099|NCT01671293|Other|Usual care|Usual care from health centers consisting of medical indication of physical activity and healthy eating recommendations, as well as referral to Dietitian if appropriate, an invitation to participate in educational activities at health centers and periodic inspection appointments
16164145|NCT01670851|Device|Strattice|Perineal reconstruction and stoma reinforcement with Strattice
16265002|NCT00900172|Drug|carboplatin|
16164100|NCT01671280|Drug|Azithromycin IV|"The recommended dose of ZITHROMAC (azithromycin for injection) for the treatment of adult patients with pneumonia due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for at least two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 500 mg, administered as two 250-mg tablets to complete a 7- to 10-day course of therapy.
~The recommended dose of ZITHROMAC (azithromycin for injection) for the treatment of adult patients with pelvic inflammatory disease due to the indicated organisms is: 500 mg as a single daily dose by the intravenous route for one or two days. Intravenous therapy should be followed by azithromycin by the oral route at a single, daily dose of 250 mg to complete a 7-day course of therapy."
16164101|NCT01671267|Behavioral|Strength training|
16164102|NCT01671267|Behavioral|Ergonomic|
16164103|NCT01671254|Dietary Supplement|FishOil|
16164104|NCT01671254|Dietary Supplement|CBE75|
16164105|NCT01671254|Dietary Supplement|CBE150|
16164106|NCT01671254|Dietary Supplement|placebo|
16164107|NCT01671241|Device|Polyethylene wrap|
16164108|NCT01671241|Device|Polyethylene wrap|
16164109|NCT01671228|Other|Decision Aid|The Yorkshire Dialysis Decision Aid (YoDDA) resource in web and paper format
16164110|NCT01671228|Other|Decision aid + patient stories|The Yorkshire dialysis decision aid (YoDDA) plus a set of narratives provided by patients on the treatment options (home and hospital haemodialysis; continuous ambulatory and automated peritoneal dialysis
16164111|NCT01671228|Other|Decision Aid + values task|The Yorkshire Dialysis decision aid (YoDDA) plus a set of questions to help patients explore what aspects of their life important to them about this decision (values clarification)
16164112|NCT01671189|Other|SMS Reminder Software Tool|The 150 patients in the intervention arm of the study will receive SMS reminders regarding their upcoming appointments. Working in parallel with the SMMC electronic medical records system, the software tool will automate reminders that request text responses from patients to either confirm or request to reschedule their upcoming appointments. This bidirectional text messaging system would not interfere with the clinics' existing reminder protocol.
16164113|NCT01671176|Device|Wide diameter bone anchored implant|4.5 mm wide diameter bone anchored implant
16164114|NCT01671163|Procedure|Endoscopic Ultrasound (EUS) for fiducial placement|Endoscopic Ultrasound (EUS) used for the placement of fiducial markers in tissue as outlined by the radiation oncologist
16164115|NCT01671150|Drug|endotoxin|Low-dose endotoxin (0.8 ng/kg of body weight): EC.O:113 administered once
16164116|NCT01671137|Other|Lactobacillus Rhamnosus Strain GG|Lactobacillus Rhamnosus Strain GG
16164117|NCT01671124|Other|Soline capsule|
16164118|NCT01671111|Drug|SSP-004184AQ|"Long term extension study of 8-75 mg/kg/d of SSP-004184AQ (equivalent to 7-68 mg/kg/d free acid or active form)"
16164119|NCT01671085|Drug|LY3015014|Administered SQ
16164120|NCT01671085|Drug|Placebo|Administered SQ
16164121|NCT01671072|Biological|TissueGene-C|TissueGene-C at 1.8 x 10^7 cells
16164122|NCT01671072|Drug|Normal Saline|Sodium chloride 0.9%, 3.5ml
16164123|NCT01671033|Behavioral|Biofeedback|Patients with panic disorder practice muscle relaxation with temperature biofeedback monitor, and send the temperature data to server via internet every day. Therapist gives comments and suggestions on line. Patients also have to complete some self-rating scales on browser every day or every week.
16164124|NCT01671033|Behavioral|Muscle Relaxation|Patients with panic disorder practice muscle relaxation via internet every day. Therapist gives comments and suggestions on line. Patients also have to complete some self-rating scales on browser every day or every week.
16164125|NCT01671020|Drug|Fimasartan|Period 1 fisrt administration of fimasartan 60mg Period 2 second administration of fimasartan 30mg
16164126|NCT01671020|Drug|Fimasartan|Period 1 first administration of fimasartan 30mg Period 2 second administration of fimasartan 60mg
16164127|NCT01670994|Biological|ALT-801|Intravenous infusion; 2 treatment cycles: on day 1, 3, 8, and 15 of each cycle
16164128|NCT01670981|Biological|ixmyelocel-T|12-20 transendocardial injections of 0.4 mL of ixmyelocel-T per injection into the left ventricle.
16164129|NCT01670981|Other|Placebo|12-20 transendocardial injections of 0.4 mL of vehicle control per injection into the left ventricle.
16164130|NCT01670955|Dietary Supplement|Jobelyn|Jobelyn is a sorghum bicolor extract marketed as dietary supplement
16164131|NCT01670955|Drug|Ferrous Sulphate + Folic Acid|Ferrous Sulphate 600mg, thrice daily + Folic Acid, 5mg daily
16164132|NCT01670942|Other|hypobaric chamber|We will use a large (26 tons) multi-place hyperbaric and hypobaric chamber at IMC in Murray, Utah (elevation 1500m or 4500ft, average ambient barometric pressure 645mm Hg). In the hypobaric study, the barometric pressure will be lowered to 554mm Hg (phase 1) or 471mm Hg (phase 2) over 20 minutes and held there for two hours.
16164133|NCT01670929|Drug|Progesterone|
16164134|NCT01670929|Other|Placebo|
16164135|NCT01670916|Dietary Supplement|probiotics|Capsule with 1 x 10**9 Lactobacillus rhamnosus GG and 1 x 10**8 Bifidobacterium BB12. Two capsules once a day. The capsules are opened and the content is dissolved in mother's milk or water if the baby is given any milk. In tube fed infants, two drops are given in the mouth and the rest in the nasogastric tube.
16164136|NCT01670890|Drug|TMZ|patients were treated with TMZ alone,Oral TMZ 50mg/m2/day,day 1 to 28,for 6 cycles
16164137|NCT01670890|Drug|TMZ plus CDDP|patients were treated with TMZ plus CDDP,CDDP was administered iv from day 1 to 3 with the total dose of 100mg and TMZ was administered orally 50mg/m2/day,day 1 to 28,for 6 cycles
16164138|NCT01670877|Drug|Neratinib|
16164139|NCT01670877|Drug|Fulvestrant|
16164140|NCT01670877|Drug|Trastuzumab|
16164141|NCT01670877|Procedure|Tumor biopsy|-Optional at baseline and disease progression
16164142|NCT01670877|Procedure|Research blood sample|-Baseline, cycle 1 day 15, cycle 2 day 1, cycle 3 day 1, day 1 of each odd cycle, end of treatment (progression)
16164143|NCT01670864|Behavioral|Counseling group|The content for the brief counseling group adopts a AWARD approach including asking the smoking habit, warning about the health risks associated with smoking, advising the smokers to quit, referring to specialized service, and repeating the above messages. A special designed health education card, based on the health education model, will be also provided to the participants. Additional telephone follow-up counseling (reminder) at 1-week & 1-month will be made to the participants in this group.
16164146|NCT01670825|Procedure|Pulsed radiofrequency|Local anesthetic injection and pulsed radiofrequency treatment x 6 minutes over each affected occipital nerve
16164147|NCT01670825|Drug|Corticosteroid injection|Corticosteroid and local anesthetic injection plus sham pulsed radiofrequency over each affected occipital nerve
16164148|NCT01670825|Drug|Local anethestic injection|
16164149|NCT01670812|Drug|FFP+HDMP+Rituximab|This is a single arm, multicenter clinical trial, and the regimen including Fresh frozen plasma 400ml IV day0, Rituximab: 375 mg/m2 IV day0(after infusion of FFP), methylprednisolone 1g/m2(up to 1.5g) IV day1-day5
16164150|NCT01670799|Drug|Ketorolac|This is a pilot (feasibility) trial to determine the availability, concentration and racemic mixture of a clinically indicated pain medication, ketorolac, in the peritoneal cavity and the subsequent effect on free floating ovarian cancer cells in patients after cytoreductive surgery for ovarian cancer.
16164151|NCT01670786|Procedure|pleurodesis|Comparison of two dosages of iodopovidone as an agent for pleurodesis in malignant pleural effusion
16164152|NCT01670773|Drug|CAT-1004|
16164153|NCT01670773|Drug|Salsalate + DHA|
16164154|NCT01670773|Drug|Placebo|
16164155|NCT01670760|Device|Zero-heat-flux thermometry|The zero-heat-flux thermometer will be placed on the subject's lateral forehead for the duration of the surgery to measure deep tissue temperature.
16164156|NCT01670747|Radiation|Chest computed tomography|
16164157|NCT01670734|Drug|alirocumab SAR236553 (REGN727)|"alirocumab SAR236553 (REGN727) is a fully human monoclonal antibody that binds PCSK9 (proprotein convertase subtilisin/kexin type 9)
~Pharmaceutical form:Solution for injection Route of administration: subcutaneous"
16164158|NCT01670721|Drug|AFLIBERCEPT|Pharmaceutical form:Concentrate for solution for infusion; Route of administration: Intravenous
16164159|NCT01670721|Drug|Irinotecan|Pharmaceutical form:Concentrate for solution for infusion; Route of administration: Intravenous
16164160|NCT01670721|Drug|Fluorouracil|Pharmaceutical form:Concentrate for solution for infusion; Route of administration: Intravenous
16164161|NCT01670721|Drug|Leucovorin|Pharmaceutical form:Concentrate for solution for infusion; Route of administration: Intravenous
16164162|NCT01670708|Behavioral|HOPE|HOPE Court Judge provides warning hearing; random drug testing; violation hearing and jail/other sanctions for failed drug test or failure to comply with other probation conditions.
16164163|NCT01670708|Behavioral|Probation as Usual|Probation officer supervises following standard protocols.
16164164|NCT01670682|Procedure|ischia spinous fascia fixation|Subjects of this group were submitted to surgical treatment with ischia spinous fascia fixation.
16164165|NCT01670682|Procedure|Modified Pelvic Floor Reconstruction Surgery with Mesh|Subjects of this group were submitted to surgical treatment with Modified Total Pelvic Floor Reconstruction Surgery with Mesh.
16164166|NCT01670682|Device|polypropylene mesh(Gynemesh)|Pelvic floor reconstruction will be conducted using surgical mesh made from polypropylene.
16164167|NCT01670669|Drug|prucalopride|0.01 mg/kg/day to 0.03 mg/kg/day prucalopride (R108512) oral solution
16164168|NCT01670656|Drug|Nomegestrol acetate contraceptive vaginal ring (NOMAC-CVR)|Either 700 or 900 mcg NOMAC and 300 mcg E2 intravaginal ring for two 28-day cycles
16164169|NCT01670656|Drug|Etonogestrel containing contraceptive vaginal ring (ENG-CVR)|Either 100 or 125 mcg ENG and 300 mcg E2, intravaginally for two 28-day cycles
16164170|NCT01670656|Drug|Placebo|Placebo to match vaginal ring, intravaginally for two 28-day cycles
16164171|NCT01670656|Drug|Ibuprofen|Ibuprofen 400 mg will be dispensed throughout the entire study as needed as rescue medication for treating menstrual cramping pain. The maximum daily ibuprofen dose is 3200 mg (8 tablets)
16164172|NCT01670643|Behavioral|Video camera magnifier|reading with video camera magnifier
16164173|NCT01670630|Procedure|Sheathed speculum examination|
16164174|NCT01670630|Procedure|Standard speculum examination|
16164175|NCT01670617|Other|Particulated Juvenile Articular Cartilage|Treatment of articular cartilage defects up to 7.5 cm2
16164176|NCT01670604|Drug|6% HES 130/0.4 in NaCl 0.9% (Voluven, Fresenius Kabi, Bad Hom-bourg, Germany)|
16164177|NCT01670604|Drug|Tetraspan, B. Braun, Melsungen, Germany|
16164178|NCT01670591|Behavioral|PS - Prevention in School|
16164179|NCT01670578|Biological|PRP|
16164180|NCT01670578|Device|Hyaluronic acid|
16164181|NCT01670565|Drug|Belimumab|Belimumab (Benlysta®) decreases B-Cell survival and has been FDA approved for the treatment of systemic lupus erythematosus, another rheumatic autoimmune disease. Belimumab is a recombinant, fully human monoclonal antibody; it binds to the soluble human B lymphocyte stimulator (BLyS) with high affinity and inhibits its biologic activity. Prior research provides a robust rationale for the investigation of belimumab in combination with MMF (Cellcept ®) for the treatment of early diffuse cutaneous systemic sclerosis.
16164182|NCT01670552|Drug|Nimesulide + Pantoprazole|1 tablet each 12 hours for 14 days plus 1 tablet each 12 hours for 14 days of the Naproxen + Esomeprazole placebo.
16164183|NCT01670552|Drug|Naproxen + Esomeprazole|1 tablet each 12 hours for 14 days plus 1 tablet each 12 hours for 14 days of the Nimesulide + Pantoprazole placebo.
16164184|NCT01670539|Device|HomMed Telemonitor|"A HomMed Telemonitor wireless telemonitoring system collects data on a daily basis, including heart rate, blood pressure, oxygen level, body temperature, weight, responses to 9 pre-programmed questions (including difficulty breathing, fatigue, limited activities, difficulty taking meds, pain). Telemonitored results are transmitted to the research office for analysis and contact to patient by clinical research nurses."
16164185|NCT01670526|Drug|Rivastigmine Transdermal Patch|Cholinesterase Inhibitor
16164186|NCT01670513|Drug|IDP-118 Low Strength|8 weeks
16164187|NCT01670513|Drug|IDP-118 High Strength|8 weeks
16164188|NCT01670500|Drug|Cisplatin|administered intravenously every 3 weeks for 4 doses
16164189|NCT01670500|Drug|Cyclophosphamide|administered with doxorubicin intravenously every 2 or 3 weeks for 4 doses
16164190|NCT01670500|Drug|Doxorubicin|administered with Cyclophosphamide intravenously every 2 or 3 weeks for 4 doses
16164191|NCT01670487|Device|Vapocoolant|Topical stream of 4 to 10 seconds duration to skin
16164192|NCT01670487|Device|Sterile water|Topical intervention of sterile water stream 4 to 10 seconds to skin.
16164224|NCT01670201|Device|Mepilex Transfer Ag|Silver dressing
16164225|NCT01670188|Device|Pneumatic SCD - VenaFlow System (DJO Global)|
16164193|NCT01670474|Drug|rt-PA (2mg/2mL) actilysis|At the first catheter dysfunction (Qb < 250 ml/min) due to thrombotic event, the patient will receive rt-PA (2mg/2mL Alteplase vial - Cathflo, Boehringer Ingelheim, Ingelheim, Germany). Each lumen of the thrombosed catheter is locked with the exact volume (luminal volume) of rt-PA during 45 min. All catheters analyzed (fmDLC, polyDLC and siDLC) will be locked with the exact volume (luminal volume) of rt-PA during 45 min. Each catheter analyzed will be filled with rt-PA (2mg/2mL) if they are dysfunctional as described above in Arm/Group Descriptions: i.e. fmDLC, polyDLC amd siDLC.
16164194|NCT01670474|Drug|rt-PA|At the first catheter dysfunction (Qb < 250 ml/min) due to thrombotic event, the patient will receive rt-PA (2mg/2mL Alteplase vial - Cathflo, Boehringer Ingelheim, Ingelheim, Germany). Each lumen of the thrombosed catheter is locked with the exact volume (luminal volume) of rt-PA during 45 min. Each catheter analyzed in this study (i.e. fmDLC, polyDLC, siDLC) will be filled with rt-PA (2mg/2mL) if they are dysfunctional as described above in Arm/Group Descriptions.
16164195|NCT01670461|Behavioral|FACE|FACE intervention goal is to facilitate conversations about EOL care between adolescents and their legal guardians/surrogates to increase congruence in treatment preferences, to decrease decisional conflict, while supporting plans and actions, psychological adjustment and quality of life. Three 60 to 90-minute sessions in a dyadic format with a trained/certified interviewer. Session 1. The Lyon Family Centered Advance Care Planning Survey©. Session 2. Respecting Choices® Family-Centered Cancer Specific ACP Interview. Session 3. Completion of Five Wishes©.
16164196|NCT01670461|Behavioral|Standard of Care (SOC) Control|"Standard of Care (SOC) control will be provided with written information that encourages conversation the treatment team. At Children's National the following represent hospital policy:  … regarding advance directives … to honor each non-minor patient's wishes … to encourage and assist patients in determining and expressing their preferences regarding treatment decisions for use in the event they subsequently become unable to make such decisions. Upon admission if they do not have an advance directive, they should be given the Advance Directive Information Booklet and the Advance Directive Checklist. If they already have one, the patient is asked to provide a current copy, and it is placed in the medical record."
16164197|NCT01670448|Procedure|PECBLOCK under echoguidance|Performance of block under echography
16164198|NCT01670435|Drug|Ciprofloxacin (BAYQ3939)|Patient treated with Ciproxan as a first line treatment in daily clinical practice
16164199|NCT01670409|Radiation|SMART|The PTV (planning target volume) of gross tumor will receive radiation dose of 66Gy, 2.2Gy per fraction and the PTV of subclinical disease will receive 54Gy, 1.8Gy per fraction,5 fraction per week.
16164200|NCT01670409|Drug|PF|Concurrent and adjuvant chemotherapy: Cisplatin, 80mg/m2, intravenous on day 1, 5fluorouracil 0.5/m2, intravenous on d1 to d4. Two cycles during radiation treatment on d1 and d28. Two additional cycles after radiation treatment, 4 weeks per cycle.
16164201|NCT01670370|Drug|R-GemOx|Rituximab Gemcitabine Oxaliplatin
16164202|NCT01670357|Drug|DA-6034 3%|Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks
16164203|NCT01670357|Drug|DA-6034 5%|Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks
16164204|NCT01670357|Drug|DA-6034 Placebo|Eye drop, 1 drop/each eye, 4 times/day, for 4 weeks
16164205|NCT01670344|Procedure|Treatment with investigational method (virtual implant positioning system)|
16164206|NCT01670344|Procedure|Treatment with surgical standard of care|
16164207|NCT01670331|Behavioral|Psychological preparation|"Session 1: Help patients understand their relationship to food. Patients complete a 'food diary' as 'homework'. Give information about lifestyle changes after surgery. Presents the model of 'stress' and how it influences 'overeating', to develop a more balanced lifestyle and better QoL.
~Session 2: 'Intervention' using Compassion Focussed Therapy model to understand relationship to food from their diary. Help develop a 'minimising overeating plan' (a 'relapse prevention' plan). Help learn to meet needs in other ways than food.
~Session 3: Focus on physical body. Current body image, explore hopes and expectations for after surgery. Consider how to manage changes to social reactions and sexual relationships that may occur."
16164208|NCT01670318|Device|platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts)|
16164209|NCT01670305|Procedure|Residual pockets will be treated by laser + photosensitizer|Experimental group: Residual pockets will be treated by laser + photosensitizer
16164210|NCT01670305|Procedure|Residual pockets will be treated only photosensitizer|Placebo Comparator: Residual pockets will be treated only photosensitizer
16164211|NCT01670305|Procedure|Residual pockets will be treated scaling and root planing|Active Comparator: Residual pockets will be treated scaling and root planing
16164212|NCT01670305|Procedure|laser + photosensitizer associated with scaling and root planing|Experimental group: furcation defects will be treated by laser + photosensitizer associated with scaling and root planing
16164213|NCT01670305|Procedure|furcation defects will be treated by scaling and root planing|Active Comparator: furcation defects will be treated by scaling and root planing
16164214|NCT01670292|Other|HVLA-SM|High Velocity Low Amplitude Spinal Manipulation
16164215|NCT01670279|Drug|Brexpiprazole|up to 3mg oral dose once daily
16164216|NCT01670279|Drug|Placebo|
16164217|NCT01670266|Drug|ONO-9054|
16164218|NCT01670266|Drug|Placebo|
16164219|NCT01670253|Behavioral|Group 1|"6 hour fast from all solid foods and milk beverages
~2-hour thirst period before examination (patient may be in the period from 6 to 2 hours before the study drink any kind of clear liquids, ie liquids containing no milk products)
~Approximately 2 hours before the time of examination please drink a glass (about 2 cups) clear sugary liquid - eg lemonade, apple juice, iced tea, soda or the like."
16164220|NCT01670240|Drug|Adalimumab|
16164221|NCT01670240|Drug|Placebo|
16164222|NCT01670227|Behavioral|PARENTCORPS|ParentCorps is a culturally-informed, universal intervention (for all children enrolled in Pre-K within an elementary school) designed to promote positive behavioral supports for children at home and in the classroom. ParentCorps includes two complementary components: 1) parent and child group intervention (13 2-hour sessions after school) for Pre-K students and their families; 2) professional development and individual consultation for early childhood teachers.
16164223|NCT01670214|Procedure|pulsed electromagnetic field|parameters of the pulsed electromagnetic field are frequency:10 Hz, intensity 4-5 mT, 6 sessions( 2 week) for placebo and phase 1 treatment ( 3 sessions in week) and added 6 sessions for phase 2 treatment. the solenoid diameter of instrument is 70 cm is placed around the head.
16265003|NCT00900172|Drug|paclitaxel|
16164226|NCT01670175|Drug|Sirolimus, Cyclophosphamide, Topotecan|Dosing of cyclophosphamide and topotecan will be 25 mg/m2/dose and 0.8 mg/ m2 /dose respectively for dose levels 1 and 2. Level 3 dosing will escalate cyclophosphamide to 50 mg/ m2/dose. If level 1 dosing not tolerated, patients will be enrolled in level -1 cohort with cyclophosphamide and sirolimus administered only on days 1-14. If level -1 not tolerated, patients will be enrolled in level -2 with topotecan administration limited to days 1-7.
16164227|NCT01670162|Drug|Aflibercept|Intravitreal Injection 2mg/0.05mL Aflibercept
16164228|NCT01670149|Drug|Rifaximin|Tablets
16164229|NCT01670149|Drug|Placebo|Tablets
16164230|NCT01670136|Drug|1 dose of sildenafil|A single IV dose of sildenafil will be administered over 90 minutes with no greater than a 15-minute flush. Final dose to be determined based on at least the first 4 participants enrolled in Cohort 1; final dose expected to be a single dose between 0.25 and 0.5 mg/kg.
16164231|NCT01670123|Behavioral|Personalized Real-Time Intervention for Stabilizing Mood|Interactive mobile web-based behavioral intervention targeting symptoms of bipolar disorder
16164232|NCT01670110|Drug|Pasireotide LAR|Injectible, 60mg per month
16164233|NCT01670110|Drug|Placebo|To be injected once per month
16164234|NCT01670097|Drug|Dexamethasone|"Group 1 Blinded Phase: 8 mg (2 capsules of 4 mg) given orally twice a day for 4 days, then 4 mg given orally twice a day for 3 days.
~Open Label Phase Groups 1 and 2: 4 mg by mouth twice a day for 7 days."
16164235|NCT01670097|Drug|Placebo|Group 2 Blinded Phase: Two capsules by mouth twice a day for 4 days, followed by one capsule twice a day for 3 days.
16164236|NCT01670097|Behavioral|Questionnaires|Questionnaires completed at baseline and at day 7 and 14. It should take about 15 minutes to complete these questionnaires.
16164237|NCT01670097|Device|Spirometer|Patient to blow into spirometry machine 1 time a day to test lung function.
16164238|NCT01670097|Other|Phone Calls|Patient called by phone 1 time each day to ask about level of shortness of breath and to remind patient to take capsules. These calls should last about 5 minutes.
16164239|NCT01670084|Drug|nilotinib|Given PO
16164240|NCT01670084|Biological|rituximab|Given IV
16164241|NCT01670084|Drug|cyclophosphamide|Given IV
16164242|NCT01670084|Drug|doxorubicin hydrochloride|Given IV
16164243|NCT01670084|Drug|vincristine sulfate|Given IV
16164244|NCT01670084|Drug|methotrexate|Given IV or IT
16164245|NCT01670084|Drug|cytarabine|Given IV or IT
16164246|NCT01670084|Drug|prednisone|Given PO
16164247|NCT01670084|Drug|mesna|Given IV
16164248|NCT01670084|Drug|dexamethasone|Given IV or PO
16164249|NCT01670084|Drug|leucovorin calcium|Given IV
16164250|NCT01670071|Drug|Paliperidone extended-release|Patients will receive 6 mg to 12 mg of paliperidone extended-release tablet once daily orally.
16164251|NCT01670071|Drug|Risperidone immediate-release|Patients will receive 3 mg to 7 mg of risperidone immediate-release tablet orally.
16164252|NCT01670045|Drug|Tocilizumab|Tocilizumab in accordance with the licensed label recommendation.
16164253|NCT01670032|Drug|Experimental: CD07223 1.5 % Topical Gel BID|Eligible subjects are to apply study medication twice a day (BID) for seven days. All lesions will be treated with study medication. Scheduled study visits will occur at Day 1, Day 3, Day 8 and Day 15
16164254|NCT01670032|Drug|Experimental: CD07223 1.5% Topical Gel TID|Eligible subjects are to apply study medication three times a day (TID) for seven days. All lesions will be treated with study medication. Scheduled study visits will occur at Day 1, Day 3, Day 8 and Day 15
16164255|NCT01670032|Drug|Placebo Comparator: CD07223 vehicle gel BID|Eligible subjects are to apply study medication twice a day (BID) for seven days. All lesions will be treated with study medication. Scheduled study visits will occur at Day 1, Day 3, Day 8 and Day 15
16164256|NCT01670032|Drug|Placebo Comparator: CD07223 vehicle gel TID|Eligible subjects are to apply study medication three times a day (TID) for seven days. All lesions will be treated with study medication. Scheduled study visits will occur at Day 1, Day 3, Day 8 and Day 15
16164257|NCT01670019|Drug|Asenapine 5-20 mg daily|5 mg QHS, or 5 mg BID, or 5 mg QAM and 10 mg QHS, or 10 mg BID
16164258|NCT01670019|Drug|Placebo 1-4 tablets daily|One placebo tablet QHS, or one placebo tablet BID, or one placebo tablet QAM and two placebo tablets QHS, or two placebo tablets BID
16164259|NCT01670006|Device|Cochlear Nucleus Cochlear Implant System|
16164260|NCT01669980|Drug|Ceftaroline fosamil|"Subjects ≥ 6 months: IV ceftaroline fosamil 15 mg/kg (or 600 mg if > 40 kg) infused over 120 (± 10) minutes q8h (± 1 hour)
~Subjects < 6 months: IV ceftaroline fosamil 10 mg/kg infused over 120 (± 10) minutes q8h (± 1 hour)
~Optional Oral Switch:
~PO amoxicillin clavulanate 45 to 90 mg/kg/day divided q12h
~PO clindamycin 13 mg/kg/dose
~PO linezolid 600 mg q12h (Cohort 1) or 10 mg/kg q8h"
16164261|NCT01669980|Drug|IV Ceftriaxone and Vancomycin|"IV ceftriaxone 75 mg/kg/day (up to 4 g/day) divided equally every 12 hours (q12h) (± 2 hours) infused over 30 (± 10) minutes AND
~IV vancomycin 15 mg/kg every 6 hours (q6h) (± 1 hour) infused over at least 60 minutes.
~Optional Oral Switch:
~PO amoxicillin clavulanate 45 to 90 mg/kg/day divided q12h
~PO clindamycin 13 mg/kg/dose
~PO linezolid 600 mg q12h (Cohort 1) or 10 mg/kg q8h"
16164262|NCT01669967|Drug|Lidocaine|Lidocaine 5 mg/kg in 250 ml of normal saline infused over 45 minutes.
16164263|NCT01669967|Drug|Diphenhydramine|Diphenhydramine 50 mg in 250 ml of normal saline infused over 45 minutes.
16164264|NCT01669941|Drug|IPTp-SP|3 tablets of sulfadoxine (500 mg) and pyrimethamine (25 mg) given at each ANC visit
16164265|NCT01669941|Drug|IPTp-DP|At each ANC visit: treatment with Dihydroartemisinin-piperaquine for three days, with the daily number of tablets depending on the weight of the woman; two tablets for women weighing 24- 35.9kg, three tablets for women weighing 36 to 74.9 kg, and four tablets for women weighing 75kg or more. The first dose will be observed; the woman will be given the additional 2 doses to take at home and there may be a home visit to confirm that the tablets were taken.
16164266|NCT01669941|Drug|ISTp-DP|At each ANC visit, women will be screened for malaria using a combined HRP-2/ pLDH (P. falciparum/ pan-malaria) rapid diagnostic test, and if positive, treated with dihydroartemisinin-piperaquine. Each tablet will contain 40 mg dihydroartemisinin and 320 mg piperaquine. Treatment will be given for three days, with the daily number of tablets depending on the weight of the woman; two tablets for women weighing 24- 35.9kg, three tablets for women weighing 36 to 74.9 kg, and four tablets for women weighing 75kg or more. The first dose will be observed; the woman will be given the additional 2 doses to take at home
16164267|NCT01669928|Drug|Anti-hypertensive Medication -|"Patients will be taking their routine blood pressure lowering medication prescribed by their GP, different patients will be using different blood pressure lowering medication.
~Dosing regimen either in the morning (between 06.00 and 11.00) or in the evening (between 18.00 and 23.00)."
16164268|NCT01669915|Dietary Supplement|vitamin D3|Vitamin D3 (cholecalciferol), 2000 IU per day
16164269|NCT01669915|Drug|omega-3 fatty acids (fish oil)|Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
16164270|NCT01669915|Dietary Supplement|Vitamin D3 placebo|Vitamin D placebo
16164271|NCT01669915|Dietary Supplement|Fish oil placebo|Fish oil placebo
16164272|NCT01669876|Dietary Supplement|Anatabloc(R)|Dietary supplement Anatabloc(R), as a mint-flavored lozenge, to be taken 2-3 times each day
16164273|NCT01669876|Dietary Supplement|Placebo|Placebo, as a mint-flavored lozenge, to be taken 2-3 times each day
16164274|NCT01669863|Device|ECMO|Use of veno-venous ECMO in non-intubated patients with ARDS
16164275|NCT01669863|Procedure|ECMO in non-intubated patients|Use of veno-venous ECMO in non-intubated patients with ARDS
16164276|NCT01669850|Device|Clipped anastomosis|The vascular clip devise will be used to complete the anastomosis during fistula creation.
16164277|NCT01669850|Procedure|Handsewn anastomosis|a handsewn anastomosis technique will be used during fistula creation.
16164278|NCT01669837|Device|Mesh fixation with surgical tissue glue|Laparoscopic inguinal hernia repair using surgical tissue glue for mesh fixation
16164279|NCT01669824|Drug|Acetylsalicylic acid (Aspirin, BAYE4465)|Aspirin protect (enteric coated aspirin) 100 mg/single dose/day as long-term medication
16164280|NCT01669811|Drug|Esomeprazole (D961H) twice daily|One capsule of esomeprazole 20 mg (in the form of esomeprazole magnesium salt) will be administered in the morning and in the evening
16164281|NCT01669811|Drug|Esomeprazole (D961H) once daily|One capsule of esomeprazole 20 mg (in the form of esomeprazole magnesium salt) will be administered in the morning and one corresponding placebo capsule in the evening
16164282|NCT01669798|Drug|BIBF 1120|PO 200mg BID
16164283|NCT01669785|Device|Group C|Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
16164284|NCT01669785|Device|Group A|Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
16164285|NCT01669785|Device|Group B|Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
16164286|NCT01669772|Drug|DA-9701 and placebo|Prescribe 30mg of DA-9701(motilitone) t.i.d for 1 week and then crossover to placebo.
16164287|NCT01669772|Drug|Placebo and DA-9701|Administer placebo 1 tablet t.i.d for 1 week. After 1 week of washout, crossover to 30mg of DA-9701 t.i.d. for 1 week.
16164288|NCT01669746|Biological|Autologous cultured mixed population of dermal cells|A piece of occipital scalp is taken from the subject. A mixed population of dermal cells from this tissue are expanded in culture. The cells are then harvested. These cells are then injected into the balding area of the scalp of the original subject.
16164289|NCT01669733|Other|Music|Recorded or live music will be played prior to surgery in the preoperative room. Subjects in the live music group and subjects in the recorded music group will listen to recorded music intraoperatively. An ipod with headphones will be given to the subject when she is being prepared to move to the operating room. The board certified music therapist will initiate recorded music (harp selections). Recorded music will be relaxing harp selections. The board certified music therapist will accompany the subject to the operating room and assure volume levels and electronic equipment function properly.
16164290|NCT01669733|Other|Standard of Care|The control group subjects will receive standard anesthesia, nursing and surgical care.
16164291|NCT01669720|Drug|Aflibercept|Aflibercept: 4mg/kg IV q2weeks until progression for a maximum of 2 years
16164292|NCT01669707|Drug|Endostar -Continued Pumping into+GP|Gemcitabine(G):1000mg/m2 intravenous injection on d1,8 q3w; Cisplatin (P):75mg d1 q3w; Endostar:7.5 mg/m2 Continued Pumping into vein with saline,Each pump use 120 hours and the dosage is 7.5mg/m2*5 ,on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle,Continued using 2-4cycles.
16164293|NCT01669707|Drug|Endostar -injecting into +GP|Gemcitabine(G):1000mg/m2 intravenous injection on d1,8 q3w; Cisplatin (P):75mg iv on d1 q3w; Endostar:7.5 mg/m2 injecting into vein for 4 hours with saline on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle.Continued using 2-4cycles
16164294|NCT01669694|Other|Pelvic floor PT with biomarkers|Pelvic floor physical therapy and collection of urine for biomarker analysis.
16164295|NCT01669668|Procedure|radiofrequency ablation|Undergo RFA
16164296|NCT01669668|Procedure|laparoscopy|Undergo laparoscopic ultrasound
16164297|NCT01669642|Drug|Ketamine|participants who need ketamine sedation for abscess drainage or fracture reduction will be approached for enrollment. there is no comparison group. A predetermined dose of Ketamine will be administered over 5 seconds or less intravenously. Sedation provider will assess for effectiveness of sedation at one minute.
16164298|NCT01669629|Device|delefilcon A|Daily wear soft contact lens for bilateral distance vision correction use.
16164299|NCT01669629|Device|etafilcon A|Daily wear soft contact lens for bilateral distance vision correction use.
16164300|NCT01669603|Dietary Supplement|Bifidobacterium lactis Bl-04|The study product will be a 2*109 cfus of probiotic Bifidobacterium lactis Bl-04 mixed with 1g of sucrose as a carrier.
16164301|NCT01669603|Dietary Supplement|Placebo|Placebo will be 1g of sucrose that has identical appearance, smell, and taste with the study product.
16164302|NCT01669603|Biological|Rhinovirus|rhinovirus for experimental challenge
16164303|NCT01669577|Procedure|analysis of blood samples and clinical features|clinical follow up and biochemical analysis blood at 4 time points:1-prehospital; 2-emergency room; 3- surgical center; 4-intensive care unit . 30 days follow up
16164336|NCT01669291|Drug|Agonist|Agonist (Lupron) is used to suppress endogenous pituitary LH for the premature LH surges.
16164337|NCT01669291|Drug|Antagonist|Ganirelix acetate or cetrorelix acetate Agonist is used to suppress endogenous pituitary LH for the premature LH surges.
16164338|NCT01669278|Device|Endosheath|Flexible sheathed nasopharyngolaryngoscopy
16164339|NCT01669252|Drug|Eribulin|1.23 mg/m2 eribulin ready to use solution (equivalent to 1.4 mg/m2 eribulin mesilate) IV on Days 1 and 8 of every 21-day cycle, for 4 cycles.
16165046|NCT01663623|Biological|Belimumab 10 mg/kg|Belimumab 10 mg/kg
16164304|NCT01669564|Other|Will use HIT patient feedback to activate patients.|"After completing the FAST, GIMO patients seeing a participating provider will receive(or not receive)HIT patient feedback, based on their providers' study group assignment. Feedback for each PRI will be personalized based on the medical history, family history, and other PRI reported on the FAST. A discussion of potential treatment options will be presented along with possible general referral resources. The patient will be encouraged to discuss the PRI with his or her physician.
~Patients will be provided with a list of resources, customized to their study-designated PRI, that includes ongoing programs available both in the community and GIMO to help them with behavior change and mental HRQoL."
16164305|NCT01669564|Other|Patients will not receive HIT patient feedback.|After completing the FAST (standard of care in GIMO) GIMO patients seeing a participating provider will receive (or not receive) HIT patient feedback, based on their providers' study group assignment.
16164306|NCT01669538|Drug|Galantamine|
16164307|NCT01669538|Drug|Placebo|
16164308|NCT01669512|Biological|Control Regimen|ChAd63 ME-TRAP 5 x 1010 vp on Day 0 and MVA ME-TRAP 2 x 108 pfu on Day 56
16164309|NCT01669512|Biological|Low Dose Matrix M Regimen|ChAd63 ME-TRAP 5 x 1010 vp mixed with Matrix M-1 25μg on Day 0 and MVA ME-TRAP 2 x 108 pfu mixed with Matrix M-1 25μg on Day 56
16164310|NCT01669512|Biological|Standard Dose Matrix M Regimen|ChAd63 ME-TRAP 5 x 1010 vp mixed with Matrix M-1 50μg on Day 0 and MVA ME-TRAP 2 x 108 pfu mixed with Matrix M-1 50μg on Day 56
16164311|NCT01669499|Drug|Dexamethasone acetate|
16164312|NCT01669499|Drug|Placebo|
16164313|NCT01669486|Other|CPOT, BPS|Scoring pain of the patients during nurses activity in ICU, in particular before and after nurses manoeuvers.
16164314|NCT01669473|Other|EHR Based Strategy to promote Safe and Appropriate Drug Use|"The printed tools presented in the intervention include:
~Medication Review: a consolidated list of the medications a patient is currently taking.
~Medication Sheet: a medication information sheet, including simplified prescription instructions, for each medication that a patient is newly prescribed.
~Medication List: a table that lists all medications taken by the patient and provides an orientation on how to best organize and simplify their medication regimen"
16164315|NCT01669460|Other|Red Bull™ Sugar-Free Drink|Red Bull™ Sugar-Free Drink two (250mL) cans per day for 28 days
16164316|NCT01669447|Biological|ranibizumab|"Interventional study, prospective will be conducted in a single eye of twenty consecutive patients who will receive intravitreal ranibizumab for neovascular membrane active subfoveal choroidal active due to AMD and visual acuity of 20/40 and 20/320.
~To establish the presence of active neovascularization evaluated the presence of leakage seen on fluorescein angiography and fluid, as seen in optical coherence tomography (OCT), located both intra and subretinal, or below the retinal pigment epithelium.
~Treatment with ranibizumab will be offered after extensive Discussing the pathogenesis of AMD, the treatment alternatives, as well as the possible risks of treatment with ranibizumab. Term of consent shall be obtained prior to treatment."
16164317|NCT01669434|Drug|ACEI continuation|These chronic medications will be taken without interruption preoperatively.
16164318|NCT01669434|Drug|ACEI omission|Although taken chronically by patients in this intervention, the final preoperative dose of these medications will be omitted, whether it was scheduled for the morning of surgery or the day prior.
16164319|NCT01669421|Drug|Alpha-1 Antitrypsin (human)|Comparison of Zemaira (Alpha 1 Antitrypsin Human) 120 mg/kg/weekly for four weeks versus 2 phases with same drug administered at standard doses of 60 mg/kg/weekly for four weeks each
16164320|NCT01669408|Drug|Cold crystalloid infusions, 0.9%NaCl or Ringer's solution|Infusion of 1L cold crystalloid solution (4°C) over 15 minutes
16164321|NCT01669395|Other|Early homebased rehabilitation after hospital admission|Training begins 3-5 days after discharge from hospital, performed by an occupational therapist and a physiotherapist from Gentofte Hospital in the first two weeks. From week three to six the training will be carried out by an occupational therapist and a physiotherapist from the local municipality (Gentofte municipality and Lyngby Taarbæk municipality). Training will take place at home twice a week for 6 weeks, each session lasting 45 minutes. The intervention is individualized and focuses on functional physical and compensatory training to help the patient to manage everyday life at home. A training program will be provided and the patient will be instructed to do the exercises every day
16164322|NCT01669395|Other|Usual care|After discharge from the hospital the patients are offered the usual symptom-oriented and preventive medical care and psychosocial support
16164323|NCT01669382|Device|percutaneous coronary intervention|after the intervention patients are randomized to either Angio Seal or Exo Seal
16164324|NCT01669369|Drug|Lithium Carbonate|400 patients were randomly divided into two groups according to sequence of entering the group: lithium carbonate group and control group (1:1). Patients in lithium carbonate group were treated with combinations of chemotherapy and lithium carbonate, the control group were treated with chemotherapy only. Patients were suggesting continuing this trial until the end of the chemotherapy regimen or being confirmed as disease progression by RECIST.
16164325|NCT01669369|Drug|Placebo|The shape,color and smell of placebo are similar to Lithium Carbonate tablet used in the treatment arm.Patients in this arm take placebo twice a day.
16164326|NCT01669356|Other|Parenteral supplement with enteral nutrition for patients after esophagectomy|
16164327|NCT01669356|Other|Enteral Nutrition alone for patients after esophagectomy|
16164328|NCT01669343|Drug|Letrozole|Part A Monitor standard of care letrozole use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period. Part B In overweight/obese participants who completed Part A, provide a double dose of letrozole and monitor use for 28 days; measure blood levels of estrogens and vitamin D at start and end of period.
16164329|NCT01669330|Procedure|Nissen fundoplication|Laparoscopic Nissen fundoplication
16164330|NCT01669330|Procedure|Laparoscopic antireflux surgery ad modum Watson|Laparoscopic anterior fundoplication
16164331|NCT01669317|Other|8-ounce glass of cherry juice|You will be given an 8-ounce glass of cherry juice or artificial cherry juice to drink when you arrive at the Sleep Laboratory.
16164332|NCT01669317|Other|Artificial Cherry Juice|You will be given an 8-ounce glass of artificial cherry juice
16164333|NCT01669304|Drug|Verapamil|
16164334|NCT01669304|Drug|Sertraline|
16164335|NCT01669291|Drug|Bravelle and Menopur|Bravelle and Menopur are used for controlled ovarian stimulation (COH)
16164424|NCT01668667|Drug|GSK1838262 300 mg|Drug: GSK1838262 300 mg/day Comparison of 3 doses
16164340|NCT01669239|Drug|Liposomal Doxorubicin|"Six cycles of:
~Trastuzumab 4 mg/kg loading dose on Day 1 of the first cycle, then 2 mg/kg on Days 8 and 15 of the first cycle and on Days 1, 8, and 15 of the subsequent cycles, every 3 weeks
~Pertuzumab 840 mg loading dose on Day 1 of the first cycle, then 420 mg on Day 1, every 3 weeks
~Liposomal doxorubicin 50 mg/m2 on Day 1, every 3 weeks
~Paclitaxel 80 mg/m2 on Days 1, 8, and 15, every 3 weeks"
16164341|NCT01669226|Drug|PEip (weekly) and TCiv|IP: cisplatin 50mg/m2 and etoposide 100mg/m2, weekly, 4 times; 14 days later IV: paclitaxel 175mg/m2 plus carboplatin AUC 5 or docetaxel 60-75mg/m2 plus carboplatin AUC 5
16164342|NCT01669226|Drug|TCiv|IV: paclitaxel 175mg/m2 plus carboplatin AUC 5 or docetaxel 60-75mg/m2 plus carboplatin AUC 5
16164343|NCT01669213|Drug|ramosetron|before 5 minutes spinal anesthesia, injection of ramosetron 0.3 mg
16164344|NCT01669213|Drug|ondansetron|before 5 minutes spinal anesthesia, injection of ondansetron 8 mg
16164345|NCT01669213|Drug|ondansetron|before 5 minutes spinal anesthesia, injection of ondansetron 4 mg
16164346|NCT01669213|Drug|placebo|before 5 minutes spinal anesthesia, injection of normal saline 5 ml
16164347|NCT01669200|Other|Medium Chain Triglyceride Oil|Differential changes will be compared in the test group at one month and six months with respect to serum Beta-Hydroxybutyrate and insulin levels, and at six months with respect to cognitive scores.
16164348|NCT01669200|Other|Placebo Oil|Differential changes will be compared in the control group at one month and six months with respect to serum Beta-Hydroxybutyrate and insulin levels, and at six months with respect to cognitive scores.
16164349|NCT01669187|Other|Education brochure|
16164350|NCT01669187|Other|Live education and exercise instruction|Participants will receive one to two physical therapy visits consisting of education on the lymphedema risks and prevention factors, along with detailed information about what to except post-surgery as well as with radiation/chemotherapy. Additionally, those in the intervention group will be instructed on exercises to maintain or increase glenohumeral and scapulothoracic joint ROM post surgery and will be set up with a walking program.
16164351|NCT01669174|Drug|Placebo|
16164352|NCT01669174|Drug|BYM338|BYM338
16164353|NCT01669161|Device|Vivistim System|The Vivistim System provides vagus nerve stimulation (VNS) with rehabilitation movements.
16164354|NCT01669161|Other|Rehab Only|Rehabilitation without device implant and VNS
16164355|NCT01669148|Device|Tomosynthesis|The mean glandular radiation dose for each image will be approximately 145 millirads (mrad) for a standard size breast (4.2 cm compressed breast thickness).
16164356|NCT01669148|Device|Conventional|conventional (2D) imaging (standard mammography)
16164357|NCT01669135|Other|Spinal Anesthesia with cerebral oxygen saturation monitoring|
16164358|NCT01669122|Drug|nicotine|4 mg nicotine lozenge experimental
16164359|NCT01669109|Behavioral|Hatha yoga|
16164360|NCT01669096|Biological|GSK Biologicals' investigational TB vaccine GSK 692342|2 doses administered intramuscularly according to a 0, 1 month schedule (Day 0 and Day 30), in the deltoid region of the arm
16164361|NCT01669083|Drug|GSK557296 10 mg|10 mg single oral dose. Each subject will receive 2 tablets of 5 mg GSK557296 four times a day (QID).
16164362|NCT01669083|Drug|GSK557296 150 mg|150 mg single oral dose. Each subject will receive multiple tablets of 25 mg GSK557296 either 2, 3 or 4 times a day.
16164363|NCT01669083|Drug|GSK557296 dose 3|Dose to be determined as a single dose tablet based on half-life demonstrated in Cohort 1 and Cohort 2.
16164364|NCT01669083|Drug|GSK557296 dose 4|Dose to be determined by PK of prior doses, based on half-life demonstrated in prior cohorts.
16164365|NCT01669070|Drug|FF, 50 mcg|Novel dry powder inhaler
16164366|NCT01669070|Drug|FF, 100 mcg|Novel dry powder inhaler
16164367|NCT01669070|Drug|FF, 200 mcg|Novel dry powder inhaler
16164368|NCT01669070|Drug|FF, 250 mcg|Intravenous
16164369|NCT01669044|Drug|dexmedetomidine|dexmedetomidine: IV (in the vein)at 1μg/kg in 10 minutes as a loading dose, followed by a continuous infusion at 0.3μg/kg/h.then adjust the infusion dose to maintain the ramsay scale at 3-4 scores.
16164370|NCT01669044|Drug|propofol|propofol: IV (in the vein)at 0.5mg/kg as a loading dose, followed by a continuous infusion at 0.5mg/kg/h.then adjust the infusion dose to maintain the ramsay scale at 3-4 scores.
16164371|NCT01669031|Other|Practice program|Each practice session (simulated visual field test on computer) takes 3-15 minutes
16164372|NCT01669018|Procedure|Lumbar plexus block using LUT technique|Lumbar plexus block guided by ultrasound and nerve stimulation with the patient in the lateral position and the probe in the parasagittal plane inserting the block needle between the transverse processes of L3 and L4 until an appropriate neuromuscular response is produced.
16164373|NCT01669018|Procedure|Lumbar plexus block using SSPS technique|Lumbar plexus block guided by ultrasound and loss of resistance (LOR) with the patient in the lateral position and the probe in the parasagittal plane inserting the block needle between the transverse process of L5 and the sacral bone until an appropriate LOR is produced.
16164374|NCT01668992|Behavioral|Family intervention|12-week parenting skills program for Burmese migrant and displaced children and families.
16164375|NCT01668979|Device|new system to detect Near Falls|We will invite healthy older adults with a history of falls to try the new system and assess whether the new system can induce, detect and quantify Near Fall episodes
16164376|NCT01668966|Drug|Tocilizumab|Participants will receive tocilizumab 8 mg/kg IV every 4 weeks for up to 104 weeks.
16164377|NCT01668953|Other|Platelet Rich Plasma (PRP) Injection|"The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine for local anesthetic.
~A 22-gauge needle will then be placed into the tendon followed by 15-25 gentle strokes of dry needling in which the needle pierces the tendon at multiple sites.
~For the PRP preparation, the Arthrex ACP system will be used. This is a closed, double syringe system which uses 16 mL of whole blood drawn from the patient's contralateral arm, using a 19G butterfly needle. The blood is centrifuged at 1500 rpm for 5 minutes and extracts 4-7 ml of PRP. No anticoagulant will be used.
~Fenestration of the tendon will continue as 3mL of PRP is injected into the common extensor tendon.
~The remaining PRP will be sent for analysis of platelet, WBC, and RBC concentrations."
16164420|NCT01668693|Other|Second ERA|A second ERA will be performed to confirm receptivity after further administration of Progesterone.
16164421|NCT01668680|Drug|CAPECITABINE, CELECOXIB and METHOTREXATE|daily oral treatment with CAPECITABINE, CELECOXIB and METHOTREXATE
16164378|NCT01668953|Other|Whole Blood Injection|"The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine for local anesthetic.
~A 22-gauge needle will then be placed into the tendon followed by 15-25 gentle strokes of dry needling in which the needle pierces the tendon at multiple sites.
~6mL of autologous whole blood will be drawn from the patient's contralateral arm, using a 19G butterfly needle.
~Fenestration of the tendon will continue as 3mL of whole blood biologic agent is injected into the common extensor tendon.
~The remaining 3mL will be sent for analysis of platelet, WBC, and RBC concentrations."
16164379|NCT01668953|Other|Dry Needle Fenestration|"The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine for local anesthetic.
~3mL of autologous whole blood will be drawn from the patient's contralateral arm, using a 19G butterfly needle, and discarded.
~A 22-gauge needle will then be placed into the tendon.
~15-25 strokes or as many strokes required until tendon is softened of dry needling will be performed in which the needle pierces the tendon at multiple sites. No blood will be injected into the tendon."
16164380|NCT01668953|Other|Sham Injection|"The subcutaneous soft tissues of the lateral elbow will be infiltrated with 1% lidocaine (no epinephrine) for local anesthetic.
~3mL of autologous whole blood will be drawn from the patient's contralateral arm, using a 19G butterfly needle, and discarded.
~The superficial subcutaneous soft tissues will be re-entered however, the tendon itself will not be entered and nothing will be injected."
16164381|NCT01668940|Other|Lillipops Iced Soothies (4 flavours)|Lillipops Iced Soothies are naturally flavoured freezies developed in the United Kingdom for women with morning sickness. They are available in 5 different flavours: grapefruit and tangerine, lemon and mint, chamomile and orange, lime and vanilla, and ginger. The flavours are derived from steam distillation of the peels (grapefruit, tangerine, lemon, orange, lime), mint leaves, and chamomile flowers to release and collect their essential oils. Vanilla pods and ginger are macerated and their resin is used. These flavours were chosen because they may provide relief of symptoms as they are either traditional remedies for NVP, such as ginger, or soothing and refreshing flavours, such as chamomile, vanilla and citrus.
16164382|NCT01668940|Other|Mr. Freeze Freezies|There are other commercially available freezies, such as Mr. Freeze. Mr. Freeze freezies contain simulated flavours of watermelon, cherry, blue raspberry and cream soda. However, there have been no reports, studies or claims that they are effective as a remedy for the treatment of NVP.
16164383|NCT01668940|Other|Lillipop Iced Soothies (Ginger flavour)|Lillipops Iced Soothies are naturally flavoured freezies developed in the United Kingdom for women with morning sickness. They are available in 5 different flavours: grapefruit and tangerine, lemon and mint, chamomile and orange, lime and vanilla, and ginger.The flavours are derived from steam distillation of the peels (grapefruit, tangerine, lemon, orange, lime), mint leaves, and chamomile flowers to release and collect their essential oils. Vanilla pods and ginger are macerated and their resin is used. These flavours were chosen because they may provide relief of symptoms as they are either traditional remedies for NVP, such as ginger, or soothing and refreshing flavours, such as chamomile, vanilla and citrus.
16164384|NCT01668927|Drug|Proton Pump Inhibitor|
16164385|NCT01668927|Drug|Bismuth|
16164386|NCT01668927|Drug|Metronidazole|
16164387|NCT01668927|Drug|Tetracycline|
16164388|NCT01668927|Drug|Furazolidone|
16164389|NCT01668927|Drug|Amoxicillin|
16164390|NCT01668914|Procedure|IM-SLNB|IM-SLNB is performed according to the pre-operative lymphoscintigraphy
16164391|NCT01668914|Radiation|99mTc-SC|Two syringes of 0.25~0.5 mCi 99mTc-SC in 0.2~1.0 mL volume were injected intraparenchymally into 2 quadrants of breast, at the 6 and 12 o'clock positions.
16164392|NCT01668914|Device|Histologic Examination|All IMSLNs were analyzed by histologic examination for future therapy planning.
16164393|NCT01668914|Device|LSG|lymphoscintigraphy was performed 0.5~1.0 hour before surgery
16164394|NCT01668914|Drug|Methylthioninium|Four milliliters of methylthioninium was injected intraparenchymally around the primary tumor 10 min before surgery
16164395|NCT01668901|Drug|warfarin|anticoagulation
16164396|NCT01668901|Drug|Aspirin|antiplatelet
16164397|NCT01668875|Other|Head down 30 degree postural drainage position|supine head down 30 degree on tilt table (intervention period in the treatment condition)
16164398|NCT01668875|Other|Horizontal supine lying|horizontal supine lying on tilt table (intervention period in the sham condition)
16164399|NCT01668862|Biological|Autologous Human Platelet Lysate|Subjects will receive one injection of Autologous Human Platelet Lysate in the lateral epicondyle space
16164400|NCT01668862|Drug|Corticosteroid|Subjects will receive one injection of Corticosteroid in the lateral epicondyle space
16164401|NCT01668849|Dietary Supplement|Grape extract|Grape extract self-administered by mouth daily for 35 days
16164402|NCT01668849|Drug|Lortab, Fentanyl patch, mouthwash|Lortab 5-10 mg Fentanyl patch 25 mcgs Mary's Magic Mouthwash
16164403|NCT01668836|Drug|Resveratrol|1 pill daily containing 500 mg/d of resveratrol for 30 days
16164404|NCT01668836|Behavioral|Caloric restriction|Diet of 1000kcal per day for 30 days
16164405|NCT01668823|Drug|HPPH|Given IV
16164406|NCT01668823|Drug|photodynamic therapy|Undergo photodynamic therapy with HPPH
16164407|NCT01668823|Procedure|therapeutic bronchoscopy|Undergo therapeutic bronchoscopy for endoscopic debridement
16164408|NCT01668797|Drug|Brexpiprazole|Brexpiprazole tablets 1 to 4 mg /day
16164409|NCT01668797|Drug|Placebo|Placebo comparator for 52 weeks
16164410|NCT01668784|Biological|Nivolumab|
16164411|NCT01668784|Drug|Everolimus|
16164412|NCT01668745|Biological|Early measles vaccine|
16164418|NCT01668693|Other|ERA (Endometrial Receptivity Array)|"The diagnostic tool ERA will be performed on all of the patients in order to allocate them in the group Receptive or Non Receptive and to predict the number of days of Progesterone administration necesary to obtain the Receptive prediction."
16164419|NCT01668693|Other|Personalized Embryo Transfer|When the ERA indicates receptivity, the patient will undergo the embryo transfer on the day indicated by the diagnostic tool.
16164422|NCT01668667|Drug|GSK1838262 600 mg|Drug: GSK1838262 600 mg/day Comparison of 3 doses
16164425|NCT01668667|Drug|GSK1838262 Placebo match|Drug; GSK1838262 placebo to match 600 mg, 450 mg, 300 mg doses
16164426|NCT01668654|Drug|retigabine/ezogabine|retigabine/ezogabine will be administered three times a day (TID) as add-on therapy based on weight
16164427|NCT01668641|Drug|GLPG0634|
16164428|NCT01668641|Drug|Placebo|
16164429|NCT01668615|Drug|all-trans-retinoid acid|10 mg three times a day oral administration for 4 months
16164430|NCT01668602|Device|Fast Walking with Fast Functional Electrical Stimulation (FES) Training|Functional electrical stimulation (FES) is a technique that causes a muscle to contract through the use of an electrical current. The therapist applies an electrical current to either the skin over the nerve, or over the bulk of the muscle, and this will cause a muscle contraction. The FES is delivered to 2 muscle groups (dorsiflexor and plantarflexor) timed appropriately with the gait cycle. FastFES gait training sessions may comprise up to six 6-minute bouts of walking with rest breaks between bouts (total 30-minutes of walking). The last training bout (bout 6) may comprise 6-minutes of over ground walking, during which subjects will be asked to walk as fast as they can. For safety, a physical therapist will walk with and guard the subject during over ground walking.
16164431|NCT01668602|Other|Fast Walking|Fast walking training sessions will be similar to FastFES in duration, dosage, structure but no FES will be provided.
16164432|NCT01668563|Procedure|surgical management|Surgical clipping will be performed as soon as possible following randomization, according to standards of practice, and under general anesthesia. Aneurysms thought by the treating physicians to require deliberate permanent proximal vessel occlusion, construction of a surgical bypass, or other flow-redirecting treatments that do not directly clip the aneurysm will not be excluded; these non-ISAT aneurysms are expected to be more difficult lesions to manage surgically as well as endovascularly.
16164433|NCT01668563|Procedure|Endovascular management|Endovascular treatment will also be performed as soon as possible following randomization,according to standards of practice, and under general anesthesia. Details regarding type of coils, use of adjunctive techniques such as balloon-remodeling, stents or flow-diverters, as well as post-treatment medical management issues, will be left up to the physician performing the endovascular treatment.
16164434|NCT01668550|Drug|AZD0424|"AZD0424 will be administered as a flat dose orally once a day. One treatment cycle consists of 28 days of continuous drug administration with AZD0424, with the flexibility to introduce treatment breaks if required due to cumulative toxicity.
~Combination agents and treatment regimen with AZD0424 will be confirmed and approved at a later date."
16164435|NCT01668537|Biological|LF formulation of IMVAMUNE®|
16164436|NCT01668537|Biological|FD formulation of IMVAMUNE®|
16164437|NCT01668524|Drug|ATS907|Single dose of each of three increasing concentrations
16164438|NCT01668511|Biological|ABT-981|Injection
16164439|NCT01668511|Biological|Placebo|Placebo Injection
16164440|NCT01668498|Drug|Erythromycin|Comparison of efficacy of Arm A erythromycin cream 2% daily at bedtime (doxycycline 100mg b.i.d.if skin toxicity CTC° ≥2) and Arm B doxycycline 100mg b.i.d. in patients with Metastatic Colorectal cancer (Ras wild-type)being treated with panitumumab.
16164441|NCT01668498|Drug|Doxycycline|Comparison of efficacy of Arm A erythromycin cream 2% daily at bedtime (doxycycline 100mg b.i.d.if skin toxicity CTC° ≥2) and Arm B doxycycline 100mg b.i.d. in patients with Metastatic Colorectal cancer (Ras wild-type)being treated with panitumumab.
16164442|NCT01668485|Procedure|Hypoglycemic and euglycemic glucose clamp|Each study participant will be subjected to a continuous infusion of insulin at a rate of 0.8 mU·kg-1·min-1 to induce hypoglycemia (blood glucose 2.8-3 mmol/l) for 30 minutes. At least two weeks later an identical insulin infusion will be administered and euglycemia (blood glucose 5 mmol/l) will be targeted. The order of these interventions will be subject to randomization.
16164443|NCT01668459|Drug|Cabazitaxel|25 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: maximum 6
16164444|NCT01668459|Other|Best Supportive Care|Best Supportive Care including single agent chemotherapy as determined by the patient's study physician
16164445|NCT01668446|Drug|Sildenafil|sildenafil tablets(50 mg) daily
16164446|NCT01668446|Drug|estradiol valerat|
16164447|NCT01668433|Drug|Regimens (Primaquine, Methylene blue)|Primaquine 45 mg single dose Or Methylene Blue 600 mg single dose followed by Methylene Blue 600 mg single dose or Primaquine 45 mg single dose.
16164448|NCT01668420|Other|thermal stimulation|hot and cold/warm and cool pads applying.
16164449|NCT01668407|Device|Robot-Assisted Gait Training (RAGT)|Subjects (at least 40 subjects) will undergo inpatient rehabilitation consisting of a treatment cycle using the GE-O system device, according to individually tailored exercise scheduling. The practice will include robot-assisted walking at variable speeds for 45 min with a partial body weight support (BWS). All participants started with 30-40% BWS and an initial treadmill speed of 1.5 km/h speed will be increased to a range of 2.2 to 2.5 km/h before BWS will be decreased.
16164450|NCT01668407|Procedure|Treadmill Gait Training (TT)|"Subjects (at least 40 subjects) will undergo inpatient rehabilitation consisting of a treatment cycle using the treadmill device, according to individually tailored exercise scheduling. The practice included treadmill walking at variable speed for 45 minutes. All participants will start at an initial treadmill speed of 1.5 km/h speed will be increased to a range of 2.2 to 2.5 km/h.
~All the treatment consists of 20 sessions for the lower limbs, each lasting 45 minutes, 5 days a week for 4 weeks."
16164451|NCT01668394|Behavioral|Learning and coping arm|Participation of experienced patients as co-educators. Completion of two individual clarifying interviews. Teaching style: situated, reflective, inductive.
16164452|NCT01668394|Other|Control arm|Usual care. Teaching style: deductive.
16164453|NCT01668381|Procedure|radiofrequency ablation|the patients are prepared by local anesthesia and intravenous sedative.guided by the ultrasound,the antenna used for radiofrequency ablation ablation is placed in the tumor to destroy tumor tissues,the output power and duration are depended by the tumor volume and location.
16164454|NCT01668368|Other|esophageal balloon|esophageal pressure as a surrogate for pleural pressure
16164455|NCT01668355|Other|Patient Aligned Care Team (PACT)|An integrated healthcare model to coordinate and address physical health needs of people with serious mental illness. This specialized PACT medical home model is designed for individuals with serious mental illness.
16164456|NCT01668342|Behavioral|SMS assessments & feedback|Daily symptom assessments tied to tailored feedback
16164564|NCT01667406|Drug|Kisspeptin 9.6nmol/kg|single kisspeptin dose 9.6 nmol/kg subcutaneously
16164457|NCT01668316|Behavioral|Weight loss|"Participants will be prescribed a reduced calorie diet and asked to track their diet three days per week using the online USDA MyPlate SuperTracker. This record will be accessed by the RD in order to provide diet recommendations sent by email.
~Participants will be given an exercise prescription, and encouraged to walk briskly with a provided pedometer or exercise at the campus Recreation Center every day. Participants will be asked to record the number of steps and other physical activity in a log book.
~Participants will meet with the research staff every other week to measure weight, waist and hip circumference, and record the steps from the pedometer.
~Participants will be encouraged to breastfeed their baby and provided with resources for pumping breast milk at work."
16164458|NCT01668303|Behavioral|Miami Juvenile Drug Court-MDFT|MDFT assesses and intervenes in five domains: 1) Interventions with the adolescent, 2) interventions with the parent, 3) interventions to improve the parent-adolescent relationship, 4) interventions with other family members, and 5) interventions with external systems.
16164459|NCT01668303|Behavioral|Miami Juvenile Drug Court -TAU|Each client is provided with a primary outpatient counselor who develops a treatment plan to address long-range goals. Family members are included in an assessment and treatment planning session at the beginning of treatment, but no formal family therapy is provided. Group therapy topics include self-esteem enhancement, decision-making skills, stress/anger management, communication skills, health education, teen pregnancy prevention, and occupational/career planning.
16164460|NCT01668277|Drug|7.2% NaCl|
16164461|NCT01668277|Drug|0.9% NaCl|
16164462|NCT01668264|Procedure|Echocardiograph|
16164463|NCT01668264|Procedure|Magnetic Resonance Imaging (MRI)|
16164464|NCT01668225|Procedure|Blood test|"Taking blood sample of the patient during the day 3, triggering day, oocyte collection day and pregnancy test day.
~Taking the follicular fluid during the oocyte collection day"
16164465|NCT01668212|Procedure|Doppler ultrasound|Doppler Ultrasound
16164466|NCT01668199|Drug|TZP-101|
16164467|NCT01668173|Drug|AUY922|AUY922 will be administered as an intravenous infusion over 60 minutes, on a once weekly schedule. A cycle on study will be defined as 28 days. The dose to be studied are 70 mg/m2 and 55 mg/m2 if DLTs are identified in the first 3-6 patients. The same schedule of administration will be used for all patients in this trial.
16164468|NCT01668160|Procedure|Bead placement during revision hip replacement surgery|Tantalum beads will be placed in the surrounding pelvic and femoral bone and the polyethylene component during surgical treatment of failed primary THA components
16164469|NCT01668147|Drug|[11C] desmethyl-loperamide|IV administration of 10-14 mCi of [11C] desmethyl-loperamide with PET/CT imaging
16164470|NCT01668147|Other|Control - no pretreatment|Session 1: IV administration of 10-14 mCi [11C] desmethyl-loperamide (dLop) with PET/CT imaging and brain MRI
16164471|NCT01668147|Drug|Oral ritonavir|Session 2: Pretreatment with oral ritonavir for 3 days followed by IV administration of 10-14 mCi [11C]dLop with PET/CT imaging and brain MRI
16164472|NCT01668147|Drug|Oral efavirenz|Session 3: Pretreatment with oral efavirenz for 14 days followed by IV administration of 10-14 mCi [11C]dLop with PET/CT imaging and brain MRI
16164473|NCT01668134|Radiation|Stereotactic radiation|
16164474|NCT01668121|Drug|Symbicort Turbohaler|
16164475|NCT01668121|Drug|Budesonide/formoterol Easyhaler|
16164476|NCT01668095|Other|Laboratory Biomarker Analysis|Correlative studies
16164477|NCT01668082|Procedure|surgical resection of a brain tumor|The patient will undergo surgical removal of the tumor after infusion of 13C-glucose using standard neurosurgical technique, including frameless stereotaxy for surgical navigation, and microsurgical technique.
16164478|NCT01668069|Drug|Ondansetron|Ondansetron 4mg and a placebo capsule to be taken orally every 8 hours for 5 days.
16164479|NCT01668056|Drug|Ovulation induction with choriogonadotropin alfa|Administration of 250 micrograms of choriogonadotropin alfa subcutaneously when the dominant follicle of a natural menstrual cycle reaches 16mm or more of mean diameter. Verify if this intervention is able to induce follicular wave emergence and synchronize the start of the flexible GnRH antagonist protocol of ovarian stimulation with the start of a follicular wave.
16164480|NCT01668056|Procedure|Aspiration of the dominant follicle|Aspiration of all follicles greater than 10mm in mean diameter when the dominant follicle of a natural menstrual cycle reaches 16mm or more of mean diameter. Aspiration will be guided by transvaginal ultrasound. Verify if this intervention is able to induce follicular wave emergence and synchronize the start of the flexible GnRH antagonist protocol of ovarian stimulation with the start of a follicular wave.
16164481|NCT01668056|Other|Control|Conventional flexible GnRH antagonist protocol of ovarian stimulation for in vitro fertilization, with gonadotropin star at the third day of a natural menstrual cycle.
16164482|NCT01668043|Drug|Antibody UB-421|UB-421 is administered by intravenous infusion
16164483|NCT01668030|Drug|Enzymatic agent|Enzymatic agent
16164484|NCT01668030|Drug|Bacitracin|
16164485|NCT01668017|Drug|Pimasertib|Subjects with solid tumor will be administered with Pimasertib 30 mg twice a day (BID) in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
16164486|NCT01668017|Drug|Pimasertib|Subjects with solid tumor will be administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
16164487|NCT01668017|Drug|Pimasertib|Subjects with solid tumor will be administered with Pimasertib 60 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
16164488|NCT01668017|Drug|Pimasertib|Subjects with HCC will be administered with Pimasertib 30 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
16164489|NCT01668017|Drug|Pimasertib|Subjects with HCC will be administered with Pimasertib 45 mg BID in 21-day cycles until disease progression, intolerable toxicity, investigators decision to discontinue treatment or withdrawal of consent by the subject.
16164490|NCT01668004|Biological|Golimumab|GLM 50 mg subcutaneously once monthly.
16164491|NCT01667978|Drug|Norethindrone acetate|
16164565|NCT01667406|Drug|Kisspeptin 12.8nmol/kg|single kisspeptin dose 12.8 nmol/kg subcutaneously
16164566|NCT01667406|Drug|Kisspeptin 9.6 nmol/kg double|kisspeptin dose 9.6 nmol/kg given twice 10hrs apart subcutaneously
16164492|NCT01667965|Behavioral|questionnaires|Questionnaires will be given before the patient watches a video educational tool to aid informed consent about palliative radiation therapy; and (2) after the patient watches the video educational tool. (3) If the patient receives PRT, a final questionnaire that assesses the patient's impression of the video will also be administered at the conclusion of radiation therapy.
16164493|NCT01667952|Genetic|Family History Questionnaire (FHQ)|"Consented subjects will be given the Family History Questionnaire (FHQ) to complete either in clinic or at home. Subjects who chose to complete the FHQ at home will be given a stamped envelope with a label. For participants who are children and cannot fill out the questionnaire on their own, the clinic RSA will instruct the parent, guardian, or legally authorized representative (LAR) present to fill out the questionnaire, reminding them that the You in the questionnaire refers to their child."
16164494|NCT01667952|Genetic|Salvia sample|The saliva samples will be collected in Oragene DNA Self-Collection Kits or a similar product. Patients will be instructed to donate about 2ml of saliva into a vial, which contains 2ml of product. Oragene or similar solution.
16164495|NCT01667952|Other|Blood sample|Subjects will be offered the option of a blood collection instead of saliva. For adult subjects who opt for blood collection, two tubes of blood (approximately 20cc) will be drawn from the utilizing a sterile technique. For subjects under the age of 18 who opt for blood collection, approximately 3-5cc of blood will be collected utilizing a sterile technique.
16164496|NCT01667939|Behavioral|Healthy Eating Index (HEI) in supervised pregnancies|Dietetic treatment was calculated according to height, weeks of gestation and weight, considering an energy intake of 30 kcal/kg of expected weight, distributing the resulting energy according to the percentage of macronutrients' adequation (55-65% carbohydrates, 10-20% fat and the remainder as proteins).16 On each nutritional visit, 24 hour dietary recall was done and analyzed using NutriKcal®VO software in order to evaluate the Healthy Eating Index (HEI), which is commonly employed to assess pregnant women's dietary adequacy (on a scale from 0-100), through the consumption of 12 components of food groups described previously. An improvement in diet was considered when the initial HEI score improved more than one point during the next nutritional assessment.
16164497|NCT01667926|Drug|Ketamine|ketamine infusions twice a week for three weeks, total of 6 infusions as augmentation of ongoing antidepressant regimen.
16164498|NCT01667926|Drug|Placebo|
16164499|NCT01667913|Other|6 minutes walking test|
16164500|NCT01667900|Drug|Dulaglutide|
16164501|NCT01667900|Drug|Placebo|Administered SQ in the placebo arms and to maintain the blind in the dulaglutide arms.
16164502|NCT01667874|Drug|Collatamp G sponge|Collatamp G is an antibiotic impregnated sponge
16164503|NCT01667848|Device|Optitherm® device activated|The use of Optitherm® device, which was attached to the insufflation equipment in all of the patients but was only activated by the single scrub nurse in those patients randomized to group B.
16164504|NCT01667848|Device|Optitherm® device inactivated|The use of Optitherm® device, which was attached to the insufflation equipment in all of the patients but was inactivated in group A.
16164505|NCT01667835|Behavioral|Yoga Intervention|12 week 90 minute hatha yoga session offered three (3x) per week. Hatha yoga is a form of structured physical exercises known as asanas, combined with breathing exercises called pranayama, and relaxation techniques. The yoga intervention consists of 9 different yoga poses (asanas) and 3 different breathing exercises (pranayama) that can be easily replicated and readily performed by individuals who are middle-aged and older, overweight, unfit, or who suffer from a chronic illness.
16164506|NCT01667822|Behavioral|Continued self help CBT|After the initial Guided self help, patients in this arm continue the same self help program with 1 additional guiding session.
16164507|NCT01667822|Behavioral|Individual CBT|After the initial face of self help CBT, patients in this arm receive individual CBT. The cognitive behavior therapy used in the study will be based on the protocols with best empirical support.The therapy is delivered by the same psychologist as in the first face and the second face builds on the learning's from the first face.
16164508|NCT01667809|Behavioral|Cognitive behavior therapy|Cognitive behavior therapy entails psychoeducational components, i.e. the patient is learns about the disorder and how to view it from a cognitive behavioral perspective. The most important part of the treatment is systematic behavior changes often targeted at exposure to feared stimuli. This is combined with cognitive interventions targeted at challenging negative automatic thoughts. All treatments will be delivered by licensed psychologists.
16164509|NCT01667809|Behavioral|Return to work|Participants randomized to this arm will receive an experimental treatment, based in cognitive behavioral therapy, with primary aim to help patients return to work. Interventions are aimed at solving work-related problems and comprises problem-solving training and systematic employer-patient meetings aimed at facilitating a gradual return to the workplace. Licensed psychologists deliver all treatments.
16164510|NCT01667796|Dietary Supplement|Vitamin D3|
16164511|NCT01667783|Procedure|Gastric Banding|Laparoscopic Adjustable Gastric Banding using the LapBand
16164512|NCT01667783|Behavioral|Medical Weight Loss|Weight loss intervention using diet (meal replacments), physical activity and behavioral techniques administered with weekly one-on-one counselling by dieticians
16164513|NCT01667783|Procedure|Gastric Bypass|Laparoscopic Roux-en-Y Gastric Bypass
16164514|NCT01667770|Procedure|decompression of Chiari malformation|Removal of a small section of bone at the back of the skull (posterior foramen magnum decompression) or upper cervical spine. During surgery, the covering of the brain (dura) is enlarged with a graft (autologous or non-autologous).
16164515|NCT01667744|Drug|Citalopram|10 mg/day
16164516|NCT01667731|Drug|SOF|Sofosbuvir (SOF) 400 mg tablet administered orally once daily
16164517|NCT01667731|Drug|RBV|Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
16164518|NCT01667718|Drug|Bismuth|Bismuth 220mg b.i.d for 2 weeks
16164519|NCT01667718|Drug|Lansoprazole|Lansoprazole 30 mg b.i.d.for 2 weeks
16164520|NCT01667718|Drug|Levoﬂoxacin|Levoﬂoxacin 0.5 q.d. for 2 weeks
16164521|NCT01667718|Drug|Amoxicillin|Amoxicillin 1 g b.i.d. for 2 weeks
16164522|NCT01667692|Drug|azithromycin|Azithromycin (Zithromax, Azithrocin ) is an azalide, a subclass of macrolide antibiotics. Azithromycin is one of the world's best-selling antibiotics.[1] It is derived from erythromycin, with a methyl-substituted nitrogen atom incorporated into the lactone ring, thus making the lactone ring 15-membered.
16164523|NCT01667692|Drug|clarithmycin|Clarithromycin is a macrolide antibiotic used to treat pharyngitis, tonsillitis, acute maxillary sinusitis, acute bacterial exacerbation of chronic bronchitis, pneumonia (especially atypical pneumonias associated with Chlamydophila pneumoniae), skin and skin structure infections. In addition, it is sometimes used to treat legionellosis, Helicobacter pylori, and lyme disease.
16164524|NCT01667679|Drug|100 mg Sumatriptan Tablet and OPTINOSE Placebo delivered nasally|
16164525|NCT01667679|Drug|OPTINOSE SUMATRIPTAN delivered nasally and placebo tablet|
16164526|NCT01667666|Drug|Nebulized hypertonic saline|The first 5 patients will receive 3% hypertonic saline in a nebulizer, the second 5 patients will receive 4.5% nebulized hypertonic saline, the third group 6% nebulized hypertonic saline, and the fourth group of 5 patients will receive 7% nebulized hypertonic saline. The nebulizer is dosed 2-3 times a day for 36 hours.
16164527|NCT01667653|Dietary Supplement|Probiotic|Probiotic capsule once daily
16164528|NCT01667653|Dietary Supplement|Placebo|Placebo capsule once daily
16164529|NCT01667640|Radiation|sector irradiation|"Gross Tumor Volume (GTV) is defined as the visible margin of the resection on post- operative MRI and planning- CT-scan. The Clinical Treatment Volume (CTV) is the same as the GTV plus a 5 mm margin The Planning Treatment Volume (PTV) includes the CTV plus a 1mm margin.
~A non-invasive immobilization is used for the planning CT and treatment delivery with an accuracy of ≤ 1mm.
~Treatment planning will conform to ICRU 50/62 rules for coverage of GTV, CTV and PTV. Additionally, organs at risk are delineated according to the ICRU 62 rules.
~Treatment with radiotherapy will start 2 to 3 weeks after surgery. The prescribed dose for the PTV is 30 Gy in 5 fractions.
~Isodose distributions will be calculated through the target in three planes. Dose volume histograms will be reported."
16164530|NCT01667640|Radiation|whole brain irradiation|"For whole brain radiation the entire brain, the base of the skull and the meninges are included.
~Radiation is performed fractionated with 40 Gy. The caudal boundary of the radiation-target volume is between the 2. and the 3. cervical vertebra. The radiation is performed via two lateral, opposing and isocentric contra fields. The face/ventral skull is shielded with individual blocs or MLC.
~The used energy for the radiation fields should be between 6 and 16 MV. The specification point of the dose or the standardization point has to be chosen in that way that the point is in the middle of the target volume. The target volume is radiated within the tolerance range of 95% - 107 %. The maximum/minimum doses in the target volume and possible doses peaks are documented."
16164531|NCT01667627|Dietary Supplement|Bio-25|"Each capsule of the multispecies probiotic combination Bio-25 consists of 25 billion live bacteria.
~Each type of bio-25 contains billions of live lactic acid bacteria in defined ratios of lyophilized Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasein, Lactobacillus casei, Bifidobacterium bifidum,Lactobacillus lactis, Lactobacillus rhamnosus,and Streptococcus thermophilus."
16164532|NCT01667627|Other|Placebo|Identical placebo
16164533|NCT01667614|Drug|spironolacone 25 mg tablets added to losartan|spironolactone 25 mg once daily added to losartan
16164534|NCT01667601|Other|Routine Care|Psychiatric outpatient care provided by the outpatient departments, e.g., medical consultation, brief education by psychiatric nurses and financial advices or referrals by social workers.
16164535|NCT01667601|Behavioral|Mindfulness-based program|The program was based on the psychoeducation programs by Chien et al and Lehman et al, as well as the 8-session Mindfulness-Based Stress Reduction Program by Kabat-Zinn(1990).
16164536|NCT01667601|Behavioral|Psychoeducation group|A 5-month patient psychoeducation group program (12 sessions) led by the research team will be provided.
16164537|NCT01667575|Drug|Esomeprazole|antisecretary drug of the quadruple therapy
16164538|NCT01667575|Drug|Amoxicillin|antibiotic of the quadruple therapy
16164539|NCT01667575|Drug|Clarithromycin|antibiotic of the quadruple therapy
16164540|NCT01667575|Drug|Bismuth Potassium Citrate|one of a component of a quadruple therapy
16164541|NCT01667575|Other|long duration (14 day)|
16164542|NCT01667562|Drug|Erlotinib|Daily oral doses administered until disease progression or unacceptable toxicity or death.
16164543|NCT01667549|Other|Timing of Diet and Flavor Experience|Groups differ in the timing and duration of exposure to flavored food experience.
16164544|NCT01667536|Drug|Drug: 99mTc-MIP-1404|A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc-MIP-1404
16164545|NCT01667523|Dietary Supplement|Capsaicin|1.5 mg capsaicin administered intraduodenally
16164546|NCT01667523|Dietary Supplement|Cinnamaldehyde|70 mg per intervention administered intraduodenally
16164547|NCT01667523|Dietary Supplement|Placebo|Physiological saline
16164548|NCT01667510|Dietary Supplement|Cardio Mato|Soft gel capsule for oral use
16164549|NCT01667510|Dietary Supplement|Placebo|Soft gel capsule without test material
16164550|NCT01667497|Drug|Fampridine SR|
16164551|NCT01667497|Drug|Placebo|
16164552|NCT01667484|Drug|Adderall XR 5mg|
16164553|NCT01667484|Drug|Adderall XR 10 mg|
16164554|NCT01667484|Drug|Placebo|
16164555|NCT01667471|Drug|tocilizumab [RoActemra/Actemra]|8 mg/kg iv every 4 weeks, 104 weeks
16164556|NCT01667445|Drug|Epimorph|Patient to receive 150ug of Epimorph with Spinal anaesthetic. Injection Cocktail includes: 10mg Morphine, 30mg Ketorolac, 3.5ug/ml (385ug total) of Ropivicaine, 2.5ug /ml (275ug total) Epinephrine with the remainder of the solution made of Normal Saline to a total volume of 110ml.
16164557|NCT01667445|Drug|Spinal analgesia|Patient to receive only Spinal anaesthetic (NO EPIMORPH). Injection Cocktail includes: 10mg Morphine, 30mg Ketorolac, 3.5ug/ml (385ug total) of Ropivicaine, 2.5ug /ml (275ug total) Epinephrine with the remainder of the solution made of Normal Saline to a total volume of 110ml.
16164558|NCT01667432|Biological|Peginterferon alfa-2a|Peginterferon alfa-2a commercial product (PEGASYS®) was supplied as a solution in prefilled syringes.
16164559|NCT01667419|Drug|Vemurafenib|4 tablets of vemurafenib 240 mg each (total 960 mg) were administered orally as per the schedule specified in the respective arm.
16164560|NCT01667419|Drug|Placebo|Placebo matching to vemurafenib were administered orally as per the schedule specified in the respective arm.
16164561|NCT01667406|Drug|Kisspeptin 1.6nmol/kg|single kisspeptin dose 1.6 nmol/kg subcutaneously
16164562|NCT01667406|Drug|Kisspeptin 3.2nmol/kg|single kisspeptin dose 3.2 nmol/kg subcutaneously
16164563|NCT01667406|Drug|Kisspeptin 6.4nmol/kg|single kisspeptin dose 6.4 nmol/kg subcutaneously
16164567|NCT01667406|Drug|Kisspeptin 9.6 nmol/kg + saline|kisspeptin dose 9.6 nmol/kg subcutaneously and saline subcutaneously, 10hrs apart
16164568|NCT01667393|Device|IDEV SUPERA Stent|
16164569|NCT01667393|Device|Percutaneous Transluminal Angioplasty|
16164570|NCT01667367|Drug|RG1662|Single oral dose
16164571|NCT01667367|Drug|placebo|Single oral dose
16164572|NCT01667354|Behavioral|Academic Detailing|"The intervention design is based on academic detailing, an effective method of changing physician behavior. The aim of the training is effective communication with parents who are hesitant about childhood vaccinations."
16164573|NCT01667341|Biological|GEN-003 with Matrix M-2|IM administration of GEN-003 Vaccine with 50ug Matrix M-2 Adjuvant.
16164574|NCT01667341|Biological|GEN-003|IM administration of GEN-003 Vaccine, antigens alone (without adjuvant).
16164575|NCT01667341|Biological|Placebo|IM administration of 0.5 mL dose of Dulbecco's phosphate buffered saline.
16164576|NCT01667328|Procedure|Massage therapy|Presurgical 15 minute massage performed by a licensed massage therapist
16164577|NCT01667328|Procedure|Standard of care|Control group will receive standard of care with no massage therapy
16164578|NCT01667315|Drug|Bupivacaine 0,375%|Positive or negative block results in a 1-mL reduction or increase in volume, respectively.
16164579|NCT01667302|Drug|Radiotherapy followed by chemotherapy|Radiotherapy Technique: IMRT Total dose: 50 Gy Per fraction: 2 Gy Chemotherapy: q3w Dexamethasone 40 mg d1-4 Ifosfamide 1200mg/m2 d1-4 Etoposide 60 mg/m2 d1-4 Cisplatin 20mg/m2 d1-4 Peg-asparaginase 2000 IU/m2 d1
16164580|NCT01667289|Radiation|Radiotherapy alone|Radiotherapy alone Technique: IMRT Total Dose: 50 Gy Per fraction: 2 Gy
16164581|NCT01667289|Drug|Concurrent chemoradiation|"Concurrent chemoradiation
~Chemotherapy:
~Methotrexate 40 mg/m2 weekly X 5 Radiotherapy Technique: IMRT Total dose: 50 Gy Per Fraction: 2 Gy"
16164582|NCT01667263|Drug|All-trans retinoic acid|
16164583|NCT01667263|Drug|Danazol|
16164584|NCT01667250|Device|GammaCore Active Device|
16164585|NCT01667250|Device|GammaCore Sham Device|
16164586|NCT01667237|Behavioral|Home-based pulmonary rehabilitation program|The rehabilitation program will be a self-monitored and minimally supervised home-exercise program. Exercise training modalities and intensity will be adapted to patient's individual condition. It will include aerobic and strength exercises 5 times a week for 4 weeks. Aerobic training will be done on a portable ergocycle. The target intensity will correspond to 60% of the maximal work rate achieved during the maximal progressive cardio-pulmonary exercise test, aiming for a cumulative time of 40 minutes per day. The heart rate, corresponding to an exercise level of 60% of max exercise capacity during the maximum exercise test, will be noted and patients will be instructed to train at this heart rate ± 10 beats. Muscle exercises will be performed using elastic bands and use of gravity.
16164587|NCT01667224|Dietary Supplement|Actiponin|The dried leaves of G. pentaphyllum leaves were extracted with 50% ethanol and filtered; the filtrate was concentrated under high pressure and high temperature. Damulin An and B, analytical marker of Actiponin, exist more 2.49% and 1.06% respectively in raw material.
16164588|NCT01667224|Dietary Supplement|Placebo|Amount and calorie of placebo are same with Actiponin.
16164589|NCT01667211|Drug|albumin-bound paclitaxel plus nedaplatin|intravenous albumin-bound paclitaxel, 175-200 mg/m2, d 1, was given every 3 weeks, combined with intravenous nedaplatin, 80- 100 mg/m2, d 2. At least 2 cycles will be completed for each patient, for whom responds to study treatment, 4-6 cycles will be completed.
16164590|NCT01667198|Procedure|Train the leaders course|Screening centre leaders randomized to the training intervention group will be invited to take part in a train-the-leaders course. The Train-the-leaders course will consist of three phases: (i) pre-training assessment, (ii) hands-on-training and (iii) post-training evaluation and feedback. The Train-the-leaders course will be run in polish by the team from the Maria Sklodowska-Curie Memorial Cancer Center and Institute on Oncology, Warsaw, which was trained in delivering such intervention by experts from the United Kingdom.
16164591|NCT01667198|Behavioral|Audit and feedback|Screening centre leaders randomized to the feedback group will receive (by e-mail and conventional mail) feedback on their individual screening colonoscopy quality indicators (adenoma detection rate and ceacal intubation rate) measured for the 2011 edition of the national screening program. The results will be presented in a league table in order to enable comparison with anonymous results of all endoscopists who performed at least 30 colonoscopies within the screening program. In addition, a link to a webpage containing data on individual and overall colonoscopy quality indicators over the last four years of the screening program will be provided.
16164592|NCT01667172|Device|Point-of-Care C Reactive Protein measurement on capillary blood|capillary blood fingerstick method to determine C Reactive Protein level in the blood
16164593|NCT01667159|Behavioral|Integrated Cognitive Behavioral Therapy|Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions delivered at least 1-2x each week for 6 months.
16164594|NCT01667159|Behavioral|Standard Care|Intensive outpatient therapy with teens and their parents using a variety of eclectic treatments that characterize standard care for adolescents.
16164595|NCT01667146|Other|PHARLAP mechanical ventilation strategy|Pressure control ventilation to maintain tidal volume 4-6 ml/kg and plateau pressure ≤ 30 cmH2O while tolerating respiratory acidosis if pH > 7.15; daily staircase recruitment manoeuvre and individualised PEEP titration.
16164596|NCT01667146|Other|Control group mechanical ventilation strategy|Mechanical ventilation based on the ARDSnet protocol using volume control ventilation with tidal volume 6 ml/kg, plateau pressure ≤ 30 cmH2O and FiO2/PEEP titration according to a FiO2/PEEP/oxygen saturation combination chart. This has been modified for Australian and New Zealand practice to allow pressure control and pressure support ventilation.
16164597|NCT01667133|Drug|ponatinib - Phase 1|30 mg dose of ponatinib taken orally once daily for at least the first 6 patients. If no dose-limiting toxicities are observed, the next patients will receive 45 mg dose of ponatinib taken orally once daily. Once the recommended dose is confirmed, all patients may receive the recommended dose, at the investigators' discretion.
16164598|NCT01667133|Drug|ponatinib - Phase 2|Recommended dose of ponatinib as determined in the dose escalation phase. In addition, 3 patients will receive 15 mg dose once daily for 8 days for PK testing. These PK patients may be allowed to receive the recommended dose after PK testing is complete, at the investigators' discretion.
16164599|NCT01667120|Drug|Ketorolac|Ketorolac 0.5mg/kg IV q8h x 72h.
16164600|NCT01667120|Drug|placebo|
16164603|NCT01667094|Drug|Intermittent, short infusion Ceftazidime|Ceftazidime 1g q8/24
16164604|NCT01667094|Drug|Continuous infusion Ceftazidime|Ceftazidime loading dose 1g infused over 30mins then 3g infused over 12h q12/24
16164605|NCT01667094|Drug|Intermittent, short infusion Meropenem|Meropenem 1g q8/24, infusion over 30 minutes
16164606|NCT01667094|Drug|Continuous infusion Meropenem|Meropenem initial loading dose of 500mg infused over 30 minutes followed by 1.5g infused over 12/24, q12/24
16164607|NCT01667094|Drug|Intermittent, short infusion Ticarcillin-clavulanate|Ticarcillin/clavulanate 3.1g q6/24
16164608|NCT01667094|Drug|Continuous infusion Ticarcillin-clavulanate|Ticarcillin-clavulanate loading dose 1.55g followed by 12.4g infused over 24/24 q24/24
16164609|NCT01667094|Drug|Intermittent, short infusion Cefepime|Cefepime 1g q8/24
16164610|NCT01667094|Drug|Continuous infusion Cefepime|Cefepime loading dose 500mg followed by 1.5g infused over 12/24, q12/24
16164611|NCT01667094|Drug|Continuous infusion Piperacillin tazobactam|Piperacillin tazobactam loading dose of 4.5g infused over 30 minutes followed by 18g infused over 24/24, q24/24
16164612|NCT01667094|Drug|Intermittent, short infusion Piperacillin tazobactam|Piperacillin tazobactam 4.5g q6/24
16164613|NCT01667081|Drug|Grazoprevir|Participants previously received study treatment with grazoprevir at the dose and frequency specified in the study protocol. Grazoprevir was not administered to participants in the course of this follow-up study.
16164614|NCT01667068|Other|Comprehensive non invasive cardiovascular examination|"Anamnesis with the participian
~File recherche,Physical examination
~Documentation of the carciovascular and antiretroviral medical therapy
~Electrocardiogram
~Transthoracic echocardiography
~Exercise electrocardiogram
~Measuring of the arterial media thickness
~Exercise Montreal Cognitive Assesment test
~Exercise the Grooved Pegboard test
~Blood collection
~Questionnaire to quality of life and health economics"
16164615|NCT01667029|Drug|Sulfasalazine|
16164616|NCT01667029|Drug|placebo|
16164617|NCT01666990|Drug|TwHF|Taken oral, three times per day, at a dose of 20 mg/time for 48 weeks.
16164618|NCT01666990|Drug|placebo treatment|Taken oral, three times per day, at a dose of 20 mg/time for 48 weeks.
16164619|NCT01666977|Drug|AMG 386|15mg/kg
16164620|NCT01666977|Drug|AMG 386|30 mg/kg
16164621|NCT01666977|Drug|AMG 386 Placebo|AMG 386 Placebo
16164622|NCT01666977|Drug|Pemetrexed|Pemetrexed 500 mg/m2
16164623|NCT01666977|Drug|Carboplatin|Carboplatin AUC 6
16164624|NCT01666964|Other|Blast Traumatic Brain Injury|Exposure during combat to blast-wave mediated Traumatic Brain Injury
16164625|NCT01666951|Drug|LCP-Tacro tablets|Tacrolimus
16164626|NCT01666951|Drug|Prograf|Tacrolimus
16164627|NCT01666938|Other|Diabetes Education Group|Diabetes Education Group: Diabetes Education for four month, one time per week.
16164628|NCT01666938|Other|Telephone Counseling|Telephone counseling: 12 phone calls for four months about physical activity. During the first and second month, was done four phone calls each month. During the third and fourth month, was done two phone calls per month.
16164629|NCT01666925|Biological|ChAd63 ME-TRAP / MVA ME-TRAP prime-boost immunisation|ChAd63 ME-TRAP: 5 x 10^10vp MVA ME-TRAP: 2 x 10^8 pfu
16164630|NCT01666925|Biological|Rabies vaccine|2 x 2.5IU Verorab
16164631|NCT01666912|Drug|Contraceptive implant|
16164632|NCT01666899|Procedure|Skin and blood vessel procedures|Biopsies, skin blood flow studies and ultrasound studies will be performed as described.
16164633|NCT01666886|Device|Mandibular Advancement Device (MAD)|
16164634|NCT01666873|Procedure|patients that undergo a total knee prosthesis|
16164635|NCT01666860|Procedure|Anterior Lumbar Interbody Fusion procedure|
16164636|NCT01666847|Procedure|Milking the umbilical cord before cord clamping|The procedure will involve positioning the neonate below the level of the placenta and milking approximately 20cm of umbilical cord three times over 10-20 seconds total from the placental end to the neonate. The cord will then be clamped and the neonate handed to the awaiting medical team for routine care of a premature infant.
16164637|NCT01666821|Other|Follow-up observation|a epidemiologic survey of ocular diseases in an adult population (>45 years old) in Youyi Street, Baoshan District, Shanghai, China, conducted to determine the prevalence of AMD in the region. To this end, we utilized routine ocular examinations
16164638|NCT01666808|Drug|FACBC|FACBC is given intravenously prior to PET scan
16164639|NCT01666808|Radiation|Radiation therapy|External beam radiotherapy to prostate bed +/- pelvic lymph nodes; final dose of 66.6 Gy.
16164640|NCT01666782|Biological|Standard Trivalent Influenza Vaccine|Each 0.5 mL dose contains influenza split virus antigens formulated to contain a total of 45 mcg of influenza virus hemagglutinin, 15 mcg each from the 3 influenza virus strains in the vaccine.One dose given per patient.
16164641|NCT01666782|Biological|High-Dose Influenza Vaccine|Each 0.5 mL dose of Fluzone High-Dose contains influenza split virus antigens that are formulated to contain a total of 180 mcg of influenza virus hemagglutinin, 60 mcg each from the 3 influenza virus strains in the vaccine. One dose given per patient.
16164642|NCT01666769|Drug|Micafungin|4 mg/kg/day
16164643|NCT01666769|Drug|Micafungin|8 mg/kg/day
16164644|NCT01666769|Drug|Micafungin|Standard of care Dosing
16164645|NCT01666756|Dietary Supplement|Chinese herbal formulation PHY906|Given PO
16164646|NCT01666756|Drug|sorafenib tosylate|Given PO
16164647|NCT01666756|Other|laboratory biomarker analysis|Correlative studies
16164648|NCT01666756|Other|pharmacological study|Correlative studies
16164649|NCT01666743|Drug|Ceftaroline fosamil|IV ceftaroline fosamil 600 mg infused over 60 (± 10) minutes every 12 hours (dosing may be adjusted for renal impairment)
16164650|NCT01666730|Drug|metformin hydrochloride|Given PO
16164651|NCT01666730|Drug|oxaliplatin|Given IV
16164652|NCT01666730|Drug|leucovorin calcium|Given IV
16164653|NCT01666730|Drug|fluorouracil|Given IV
16164654|NCT01666730|Other|laboratory biomarker analysis|Correlative studies
16164655|NCT01666704|Drug|BMS-823778|Capsules, Oral, 2mg, Once daily, 1 year
16164656|NCT01666704|Drug|BMS-823778|Capsules, Oral, 15mg, Once daily, 1 year
16164657|NCT01666704|Drug|Placebo matching with BMS-823778|Capsules, Oral, 0mg, Once daily, 1 year
16164740|NCT01666093|Procedure|Angioplasty of the lower limbs vessels|Standard revascularization techniques will be used in the study
16164658|NCT01666691|Drug|Beloranib|Subjects will receive ZGN-440 twice-weekly subcutaneous injections for up to 12 weeks and a total of 24 doses. A range of doses will be evaluated.
16164659|NCT01666691|Drug|Placebo|Subjects will receive placebo twice-weekly subcutaneous injections for up to 12 weeks and a total of 24 doses.
16164660|NCT01666678|Drug|BAY98-7111|2 x Naproxen Sodium 220 mg / Diphenhydramine HCl 25 mg combination under fasting conditions
16164661|NCT01666678|Drug|Naproxen Sodium (Aleve, BAYH6689)|2 x Naproxen Sodium 220 mg under fasting conditions
16164662|NCT01666678|Drug|Diphenhydramine HCl|2 x Diphenhydramine HCl 25 mg under fasting conditions
16164663|NCT01666678|Drug|BAY98-7111|2 x Naproxen Sodium 220 mg / Diphenhydramine HCl 25 mg combination under fed conditions
16164664|NCT01666665|Drug|Metformin|Metformin up to 1000mg/m2 body surface area by mouth of feeding tube up to 3 times each day for 12 months
16164665|NCT01666665|Drug|Sugar pill|Sugar pill up to 3 times per day for 12 months
16164666|NCT01666652|Biological|4 µg TDENV-PIV with Alum adjuvant|
16164667|NCT01666652|Biological|1 µg TDENV-PIV with AS03B1 adjuvant|
16164668|NCT01666652|Other|Phosphate buffered saline|
16164669|NCT01666652|Biological|1 µg TDENV-PIV with Alum adjuvant|
16164670|NCT01666652|Biological|1 µg TDENV-PIV with AS01E1 adjuvant|
16164671|NCT01666639|Behavioral|Behavioral Medical Rehabilitation plus behavioral exercise therapy|"The Intervention Group is characterized by the same treatment as in the control group, plus a modification of the exercise therapy. An Behavioral Exercise Therapy (BET) is implemented in the usual care. The Behavioral Exercise Therapy is based on a goal-oriented and systematic combination of knowledge-, behavior-, and exercise-related elements. It had been developed prior as part of a multidisciplinary treatment and was adapted for this study. The Aims of BET are gradual improvements of individual coping competencies and self-management regarding back pain as well as long-term adherence to physical activity."
16164672|NCT01666639|Behavioral|Usual Behavioral Medical Rehabilitation|"The Behavioral Medical Rehabilitation (BMR), which is in this case the control group (usual care), consists of usual orthopedic medical care, exercise therapy, individual physiotherapy, psychological treatment elements (e.g. a pain management group), occupational therapy and back school. Pain medication is given if necessary. For the most part, the psychological elements draw a distinction between more traditional concepts or orthopedic rehabilitation and the BMR. The pain management group with its cognitive-behavioral principles comprises 9 sessions of 90 minutes each."
16164673|NCT01666626|Procedure|Ultrasound stiffness imaging|Subjects will undergo transabdominal ultrasound of the distal intestine. Distal intestine motion capture will be used for off-line stiffness assessment by two-dimensional speckle tracking. In addition, shear wave imaging will be used for real-time stiffness assessment.
16164674|NCT01666613|Drug|AZD8683|Solution for injection, administered as intravenous infusion Total dose of 100µg AZD8683
16164675|NCT01666613|Drug|AZD8683|Solution to be administered orally Total dose of 950 µg AZD8683
16164676|NCT01666613|Drug|AZD8683|Dry powder inhaled via New Dry Powder Inhaler, 540 µg delivered dose AZD8683
16164677|NCT01666613|Drug|AZD8683|Dry powder inhaled via Turbuhaler™, 600 µg delivered dose AZD8683
16164678|NCT01666600|Drug|BIBF 1120|BIBF 1120 is given as 2 x minimal tolerated dose per day as long as as a clinical benefit is considered by the treating physician.
16164679|NCT01666600|Radiation|radiotherapy|36 Gy, 2 Gy / fraction, 18 fractions
16164680|NCT01666587|Dietary Supplement|Antioxidant|
16164681|NCT01666587|Drug|Prostaglandin inhibitor (Ibuprophen)|
16164682|NCT01666574|Other|Test cereal 1, Oat-based|The study design is a lunch that will be presented 4 hours after the start of breakfast. Subjects will be asked to eat until satisfied and food intake will will be measured. The effect on hunger and satiety will be measured using visual analog scales before breakfast and at 30, 60, 120, 180, and 240 minutes following consumption.
16164683|NCT01666574|Other|Test Cereal 2, Oat based|The study design is a two visit trial with each subject randomly receiving one of the cereals at each visit separated by at least a week. A lunch will be presented 4 hours after the start of breakfast. Subjects will be asked to eat until satisfied and food intake will be measured. The effect on hunger and satiety will be measured using visual analog scales before breakfast and at 30, 60, 120, 180, and 240 minutes following consumption.
16164684|NCT01666561|Other|Breakfast Test Cereal 1, Oat based|The study design is a crossover trial with each subject receiving one of the cereals in each of three visits separated by at least a week will be enrolled to investigate the satiety impact of three breakfast cereals: (a) one serving of oat based breakfast cereal 1.
16164685|NCT01666561|Other|Breakfast Test Cereal 2, Oat-based|The study design is a crossover trial with each subject receiving one of the cereals in each of three visits separated by at least a week will be enrolled to investigate the satiety impact of three breakfast cereals: (b) an equicaloric amount of Oat based breakfast cereal 2.
16164686|NCT01666561|Other|Ready-to-eat cereal|The study design is a crossover trial with each subject receiving one of the cereals in each of three visits separated by at least a week will be enrolled to investigate the satiety impact of three breakfast cereals: (c) an equicaloric amount of the ready-to-eat cold cereal.
16164687|NCT01666535|Biological|Influenza vaccination|
16164688|NCT01666522|Drug|Vitamin D|vitamin D given orally as tablets at a dosage of 2000 IU/day for 4 months
16164689|NCT01666522|Other|Physical activity|Physical activity in the form of an exercise programme consisting of 60 minutes all inclusive warming up , strengthening, resistance and stretching exercises were instigated 3 times a week for 4 months.
16164690|NCT01666509|Device|Rossoseq™|
16164691|NCT01666509|Device|Placebo|
16164692|NCT01666496|Behavioral|Experimental Video Game|Participants will play either the experimental or the control videogame for 6 weeks. Both interventions will be provided during 12 sessions, twice weekly for 6 weeks; each session will involve one and one-quarter hour of game play.
16164693|NCT01666496|Behavioral|Off the Shelf Video Game|Participants will play either the experimental or the control videogame for 6 weeks. Both interventions will be provided during 12 sessions, twice weekly for 6 weeks; each session will involve one and one-quarter hour of game play.
16164694|NCT01666483|Procedure|micro-laparoscopy|M-LPS hysterectomy was performed through one optical trans-umbilical 5 mm trocar and three 3 mm sovra-pubic ancillary ports. A 5 mm 0° endoscope and 3 mm laparoscopic instruments were utilized, choosing among graspers, cold scissors, suction/irrigation and bipolar coagulator.
16164695|NCT01666483|Procedure|Laparoendoscopic single site surgery|LESS hysterectomy was performed through a multi-channel single trocar inserted in the umbilicus using an open technique (1.5-2 cm cutaneous incision), as previously reported. Intra-abdominal visualization was obtained with a 0° 5-mm telescope with a flexible tip. Working straight 5-mm instruments were inserted into the remaining 2 ports, choosing among graspers, cold scissors, suction/irrigation bipolar coagulator and a multifunctional versatile laparoscopic device, which grasps, coagulates and transects simultaneously. In order to prevent clashing between instruments and surgeon's hands and to facilitate surgical manoeuvres, the combination of one 33 cm-long instrument with a 43 cm-long instrument was adopted. The umbilical fascia was closed with a figure-of-eight 0-Vicryl.
16164696|NCT01666470|Other|Questionnaires|DrHy-Q (Thai version) and WHOQOL-BREF-THAI will be asked
16164697|NCT01666457|Other|SOFFI|NICU nursing and multidisciplinary staff were trained to use the SOFFI infant driven feeding program. A small group of learners (20) were trained as resources via a 2-day course and the entire nursing staff received training during a 1-1.5 hour training lecture during their annual competencies.
16164698|NCT01666444|Drug|pegylated liposomal doxorubicin (PLD)|
16164699|NCT01666444|Drug|VTX-2337|TLR8 Agonist
16164700|NCT01666444|Drug|Placebo|
16164701|NCT01666431|Drug|Lapatinib|
16164702|NCT01666418|Drug|Pazopanib/Paclitaxel|
16164703|NCT01666405|Device|Urgent(R) PC Neuromodulation System|The Urgent PC Neuromodulation System (Uroplasty, Inc., Minnetonka, MN, USA), device, is an easily administered neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. This method of treatment is referred to as percutaneous tibial nerve stimulation (PTNS).
16164704|NCT01666392|Dietary Supplement|Omega-3 fatty acid|Omega-3 fatty acid, Eicosapentaenoic acid+docosahexaenoic acid in capsule form
16164705|NCT01666392|Dietary Supplement|Placebo|Placebo
16164706|NCT01666379|Drug|Fentanyl|
16164707|NCT01666366|Procedure|Coronary artery bypass grafting|
16164708|NCT01666353|Radiation|PET/CT imaging with [18F] 2-deoxy-2-(18F)fluoro-D-glucose (FDG)|PET/CT imaging with [18F] 2-deoxy-2-(18F)fluoro-D-glucose (FDG) is a potent diagnostic tool and is able to detect melanomas and other tumors, some of which are undetectable by CT.
16164711|NCT01666327|Drug|MT-1303|
16164712|NCT01666314|Drug|Orteronel|Orteronel tablets
16164713|NCT01666314|Drug|Orteronel Placebo|Orteronel placebo-matching tablets
16164714|NCT01666314|Drug|Prednisone|Prednisone 5 mg
16164715|NCT01666301|Drug|comparison between darbepoetin alfa and C.E.R.A. and different administration intervals|
16164716|NCT01666262|Biological|Vaccine A/17/CA/2009/38 (H1N1)|Pandemic Live Attenuated Influenza Vaccine (PLAIV) Candidate Strain A/17/CA/2009/38 (H1N1)
16164717|NCT01666262|Other|Placebo:Stabilizer|5% sucrose
16164718|NCT01666249|Biological|Immunoglobulin Anti-RhD|Participants will receive a single intramuscular administration of 300 mcg/2mL, correponding 1500 UI of Human Immunoglobulin Anti-RhD (Kamrho-D - Panamerican), up to 72 hours post exposition (child-birth).
16164719|NCT01666236|Other|Triple Therapy|"The treatment (single group) will be treated with reduced-fluence Photodynamic Therapy (Visudyne -Verteporfin infused over 10 minutes at a dose of 6mg/m2 and following by activating light [wavelength of 689 nm] applied 15 minutes after the start of infusion with a light dose of either 25 J/cm2 for 83 seconds), followed by an Intra-vitreous triamcinolone (4mg/0.1ml) on the same day.
~After 10 days, patients will be subjected to an injection of Intra-vitreous ranibizumab (0.5 mg/0.05 ml). After this first injection, Intra-vitreous ranibizumab will be repeated twice, on a monthly basis, for a total of three injections"
16164720|NCT01666223|Drug|Colesevelam|Colesevelam 3750 mg dissolved in 100 ml saline, administered in a feeding tube at time = 0.
16164721|NCT01666223|Drug|Chenodeoxycholic Acid|1.250 mg dissolved in 100 ml saline, administered in a feeding tube at time = 0.
16164722|NCT01666223|Other|saline|100 ml saline
16164723|NCT01666223|Drug|Colesevelam 3750 mg + chenodeoxycholic acid 1250 mg|Colesevelam and chenodeoxycholic acid dissolved in 100 ml saline, administered in a duodenal tube at time = 0.
16164726|NCT01666197|Drug|diclofenac potassium 25 mg tablet|diclofenac potassium 25 mg tablet
16164727|NCT01666197|Drug|placebo|placebo
16164728|NCT01666171|Drug|metformin hydrochloride|
16164729|NCT01666171|Other|clinical observation|
16164730|NCT01666171|Other|diagnostic laboratory biomarker analysis|
16164731|NCT01666171|Other|imaging biomarker analysis|
16164732|NCT01666171|Other|medical chart review|
16164733|NCT01666171|Procedure|digital mammography|
16164734|NCT01666158|Behavioral|Exercise|The exercise component will consist of 20 min of general exercise training, 3 days per week, alternating between aerobic and resistance training. The exercise program will be individualized based upon the baseline fitness test (according to the American College of Sport Medicine, ACMS, standard) and will include: a 5 min warm-up, either 25 min of aerobic exercise (starting at 30- 40 of heart rate reserve, HRR), or 25 min of resistance training (5 exercises targeting major muscle groups performed at an intensity of 8-12 repetition maximum), and a 5 min cool-down.
16164735|NCT01666145|Device|Advanced Image Guidance|Patients with hepatocellular carcinoma will be treated through laparoscopic microwave ablation surgery, in which the surgeon will utilize a new guidance system for needle placement.
16164736|NCT01666132|Other|intramyocardial injection of BM cells|only intramyocardial, NOGA guided injection on BM cells.
16164737|NCT01666132|Other|intramyocardial / intracoronary injection of BM cells|combination of intramyocardial, NOGA guided injection of BM cells and intracoronary injection of those cells
16164738|NCT01666132|Other|Best medical therapy|initially no intervention; crossover to therapy 6 months after enrollment
16164739|NCT01666119|Drug|BEMA Buprenorphine NX films|BEMA Buprenorphine NX films (3.5/0.6 mg and 5.25/0.9 mg buprenorphine/naloxone) will be provided in 3.361 and 5.447 cm2 film sizes, respectively.
16266818|NCT00888446|Biological|tgAAC09|
16164741|NCT01666080|Drug|Busulfan|0.4 mg/kg (0.5 mg/kg if <4 years of age) intravenously (IV) every 6 hours on Days -8 and -7.
16164742|NCT01666080|Drug|Fludarabine|40 mg/m^2 intravenously (IV) over 1 hour on days -6 through -2.
16164743|NCT01666080|Radiation|Total body irradiation|200 cGy on Day -1
16164744|NCT01666080|Biological|Stem cell transplant|stem cell infusion on day 0
16164745|NCT01666080|Drug|Keppra|Keppra will be given for seizure prophylaxis during busulfan administration as per the standard institutional protocol.
16164746|NCT01666067|Drug|placebo|
16164747|NCT01666067|Drug|vytorin|
16164748|NCT01666067|Drug|simvastatin|
16164749|NCT01666054|Other|PSV|Pressure Support Ventilation will be used until patient is extubated
16164750|NCT01666054|Other|PAV|Proportional Assist Ventilation will be used until patient is extubated.
16164751|NCT01666041|Drug|placebo|
16164752|NCT01666041|Drug|fenofibrate/omega|
16164753|NCT01666041|Drug|fenofibrate|
16164754|NCT01666028|Device|FlorenceD or similar closed loop glucose control system|Subject's glucose level will be controlled by the FlorenceD or similar automated closed loop glucose control system. The system comprises of FreeStyle Navigator® Continuous Glucose Monitoring (CGM) System (Abbott Diabetes Care, Alameda, CA, USA), Dana R Diabecare subcutaneous insulin infusion pump (Sooil Corp. Seoul, South Korea)or similar insulin pump, and MPC-based glucose control algorithm running on a portable computer.
16164755|NCT01666028|Device|CSII with real-time CGM|Subject glucose level controlled by usual insulin pump therapy in conjunction with real time continuous glucose monitoring (CGM)
16164756|NCT01666015|Other|EXERCISE (EX)|"This study will examine the effect of two phases of an EX program on several health related outcomes in pediatric patient undergoing autologous SCT. The first phase of the EX program will be an inpatient intervention and will begin when the child is hospitalized undergoing conditioning therapy and will continue until discharge.
~The second phase will be a 10-week outpatient intervention, beginning once the child is discharged. We will utilize a mixed EX program, including supervised (at the University of Calgary) and home-based training incorporating the use of the Nintendo ® Wii device™ (Wii Fit, Wii Dance and Sports™ games)."
16164757|NCT01666015|Other|Standard Care|This group will be under standard care without any EX intervention.
16164758|NCT01666002|Device|Laser Treatment (Pulsed Nd:YAG 1064 nm Laser)|0.65 Millisecond Pulsed Nd:YAG 1064 nm Laser
16164759|NCT01665989|Behavioral|Group Lifestyle Program|
16164760|NCT01665989|Behavioral|Usual Care|Visits with a dietitian at nutrition services at MGH
16164761|NCT01665976|Drug|RO4917838|film coated tablet, single dose
16164762|NCT01665976|Drug|RO4917838|oral suspension, single dose
16164763|NCT01665976|Drug|RO4927838|hard gelatin capsule, single dose
16164764|NCT01665963|Device|TopClosure(c) System|
16164765|NCT01665963|Device|Pressure Bandage|
16164766|NCT01665950|Drug|Simvastatin|The study uses the Sequential Parallel Comparison design (SPCD), with two 4-week phases: n=30 subjects are randomized 1:1 to simvastatin versus placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 for a further 4 weeks. The SPCD will allow us to pool data from both phases to estimate the simvastatin treatment effect. Subjects who respond in phase 1, and all subjects who receive simvastatin in phase 1, continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks.
16164767|NCT01665950|Drug|Placebo|Subjects (n=15) are randomized to placebo add-on for 4 weeks, with the nonresponders re-randomized 1:1 to statin vs placebo for a further 4 weeks. Subjects who respond in phase 1 continue blinded treatment in phase 2 to preserve the blind, but only phase 1 results are analyzed. Dosage for simvastatin or matched placebo 20mg daily for 8 weeks.
16164768|NCT01665937|Drug|STA-9090|"IV one time weekly for 3 weeks in 4 week cycles. Study treatment is given in 4-week time periods called cycles. Patients will receive STA-9090 for the first 3 weeks of each cycle and no treatment on the fourth week. STA-9090 will be given by intravenous (IV) infusion. IV infusions occur through an IV catheter (or tube) placed in the vein. Each infusion will last about 60 minutes.
~During each cycles patients will have blood tests, pregnancy test, and EKG. Twenty to thirty days after the last dose, patients will return for a physical exam, blood tests, urine test, EKG, and CT or MRI of chest and abdomen."
16164769|NCT01665924|Drug|GLPG0634 100mg capsule once a day for 10 days|
16164770|NCT01665911|Drug|1.5 mg Sodium Fluoride in 100 ml milk|Each subject will use this product during one of the five treatment periods in the crossover study design.
16164771|NCT01665911|Drug|1.5 mg sodium fluoride in 200 ml milk|Each subject will use this product during one of the five treatment periods in the crossover study design.
16164772|NCT01665911|Drug|3 mg sodium fluoride in 100 ml milk|Each subject will use this product during one of the five treatment periods in the crossover study design.
16164773|NCT01665911|Drug|3 mg sodium fluoride in 200 ml milk|Each subject will use this product during one of the five treatment periods in the crossover study design
16164774|NCT01665911|Other|Non-fluoridated milk, 200 ml|Each subject will use this product during one of the five treatment periods in the crossover study design.
16164775|NCT01665898|Procedure|Cold Biopsy forceps|removal of polyps using cold biopsy forceps
16164776|NCT01665898|Procedure|Cold snare biopsy|Removal of colon polyps using cold snare biopsy
16164777|NCT01665885|Device|ZOLL Thermogard XP|Induction of hypothermia with 1L cold crystalloid infusions (0,9%NaCl or Ringer's solution). Cooling catheter placement at the earliest 30min after end of thrombolysis.
16164778|NCT01665885|Device|BARD/Medivance Arctic Sun 5000|Induction of hypothermia with 1L cold crystalloid infusions (0,9%NaCl or Ringer's solution) and simultaneous start of surface cooling.
16164779|NCT01665872|Behavioral|Cognitive-Behavioral Group Therapy|CBT Group
16164780|NCT01665846|Drug|Ferumoxytol|A dose of 4 mg/kg of ferumoxytol up to a maximum of 510 mg of elemental iron will be administered.
16164781|NCT01665820|Device|Auscultate with electronic or mechanical stethoscope (3M Littmann)|
16164782|NCT01665807|Biological|Intanza|Intanza influenza vaccine, trivalent split-virion, inactivated, approved for the 2012-2013 influenza season in northern hemisphere
16164783|NCT01665807|Biological|Vaxigrip|Influenza vaccine, trivalent, split-virion, inactivated, approved for the 2012-2013 influenza season in the northern hemisphere
16164784|NCT01665794|Drug|Pomalidomide|Pomalidomide taken orally at assigned dose.
16164785|NCT01665794|Drug|Carfilzomib|Carfilzomib given by intravenous (IV) infusion at assigned dose.
16164786|NCT01665794|Drug|dexamethasone|Dexamethasone taken orally of given by IV infusion.
16164787|NCT01665794|Drug|Daratumumab|Daratumumab given by intravenous (IV) infusion at assigned dose.
16164788|NCT01665781|Drug|Erythropoietin|
16164791|NCT01665755|Device|Upstroke Compression Defibrillation|
16164792|NCT01665755|Device|Precompression Defibrillation|
16164793|NCT01665742|Dietary Supplement|Supplement containing fish oil, vitamin C, alpha-tocopherol, green tea extract and lycopene|"1 x fruit juice fortified with salmon oil containing 1000mg EPA and 1000mg DHA daily for 8 weeks
~AND
~4 x film-coated tablets containing 561mg vitamin C, 389mg alpha-tocopherol, 416mg green tea extract and 15mg lycopene daily for 8 weeks
~in conjunction with a weight management programme"
16164794|NCT01665742|Dietary Supplement|Placebo supplement|"1 x fruit juice fortified fortified with high oleic sunflower oil daily for 8 weeks
~AND
~4 x film-coated placebo tablets daily for 8 weeks
~in conjunction with a weight management programme"
16164795|NCT01665703|Procedure|FDG PET/MR|Patients will be asked to undergo a voluntary gadolinium enhanced MRI with simultaneous acquisition of FDG-PET uptake within 4 weeks prior to surgery.
16164796|NCT01665690|Other|Patient delivered partner therapy|The study will provide communities with access to free PDPT for heterosexuals with gonorrhea or chlamydial infection. PDPT will be packaged to meet the requirements of the WA State Board of Pharmacy and will include 1gram of azithromycin, information about STD, condoms, and information about enclosed medication in English and Spanish. PDPT packs for gonorrhea will also include 400mg of cefixime.
16164797|NCT01665690|Behavioral|Targeted public health partner services|During intervention periods, communities will receive public health partner services (PS) provided by Disease Intervention Specialists (DIS). Diagnosing clinicians will triage their patients to receive PS based on defined criteria associated with not ensuring partners' treatment. PS will include an offer to notify partners for each index case. When DIS notify partners they will offer them the opportunity to obtain free medication at a local pharmacy, at a clinic (as available) or through the mail. DIS will also offer to refer partners for complete evaluations insofar as such care is available in local communities.
16164798|NCT01665677|Drug|Atorvastatin calcium|40 mg PO daily
16164799|NCT01665664|Other|Hypocaloric feeding|Daily calorimetry for the first 6 days will be performed with determination of REE and the required amount of calories needed for the next 24 hours. In this group only 20% of REE will be provided but not less than 300 kcal/day.
16164800|NCT01665651|Drug|Yougui granules|Yougui granules is traditional Chinese patent medicine used to treatment patients with kidney Yang deficiency. Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.
16164801|NCT01665651|Drug|Zuogui granules|Zuogui granules is traditional Chinese patent medicine used to treatment patients with kidney Yin deficiency. Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.
16164802|NCT01665651|Drug|Yougui granules placebo|Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.
16164803|NCT01665651|Drug|Zuogui granules placebo|Granules, 11g/pouch, taking with water, 2 pouches, twice a day, three months.
16164804|NCT01665638|Drug|Canagliflozin 300 mg|Singe over-encapsulated 300 mg tablet of canagliflozin administered orally (by mouth) on Day 1 of Treatment Period 1 or Day 1 of Treatment Period 2.
16164805|NCT01665638|Drug|Placebo|Singe capsule of placebo administered orally (by mouth) on Day 1 of Treatment Period 1 or Day 1 of Treatment Period 2.
16164806|NCT01665638|Drug|Somatostatin|A primed (50 mcg in 1 mL sterile 0.9% NaCl solution i.v. injection over 1 minute) constant (500 mcg/hour) i.v. infusion of somatostatin for 4 hours approximately 2 hours after canagliflozin or placebo dosing on Day 1 of Treatment Period 1 and Day 1 of Treatment Period 2. The total dose of somatostatin administered during each period will be 50 mcg + 500 mcg/hour x 4 hours = 2050 mcg.
16164807|NCT01665638|Drug|C-peptide|Single bolus dose of 150 mcg synthetic human C-peptide in 1 mL water for injection administered i.v. (in the vein) approximately 3 hours after canagliflozin or placebo dosing on Day 1 of Treatment Period 1 and Day 1 of Treatment Period 2.
16164808|NCT01665625|Procedure|regional interventional chemotherapy group|The patients in experimental group were monitored by X-ray imaging. A 0.038 super-sliding guide wire was inserted after successful puncture, and when site of the pancreatic carcinoma was reconfirmed by conventional angiography, a 5F cobra catheter was used to place the port-catheter drug delivery system in the celiac artery (pancreatic head) or the hepatic artery (pancreatic body and tail). Finally, the port-catheter was embedded under the left upper chest.
16164809|NCT01665612|Device|Contact lens care solution|Comparison of clinical and subjective performation of the contact lens care solutions used with two types of contact lenses
16164810|NCT01665599|Drug|Testosterone gel (FE 999303)|
16164811|NCT01665586|Drug|dexmedetomidine|"Spinal anesthesia regimen Group F: 6mg bupivacaine + 20mcg fentanyl (intrathecal) + o.4 cc 5% dextrose water Group C: 6mg bupivacaine + 0.4 cc normal saline + 0.4cc 5% dextrose water
~dexmedetomidine 0.2~0.8 micro gram/kg intravenous administration after the sterilization of the spinal anesthesia level, and prehydration"
16164812|NCT01665573|Drug|PF-04457845|Acquisition of conditioning Administration of drug Extinction of conditioning
16164813|NCT01665573|Drug|Placebo|Acquisition of conditioning Administration of placebo Extinction of conditioning
16164814|NCT01665547|Drug|l-carnitine|3gm l-carnitine from day 1 to day 12 of the menstrual cycle
16164815|NCT01665534|Behavioral|High salt intake|During the high salt intake period, patients received a 10-20 mmol sodium diet plus sodium tablets (180 mEq/die) to achieve a 200 mmol intake /day for two weeks
16164816|NCT01665521|Other|HEART Pathway|During ED evaluation, patients are randomized to HEART Pathway or usual care arms.
16164817|NCT01665508|Drug|Nebivolol|Patient to start nebivolol and have repeat testing in 3 months
16164818|NCT01665495|Procedure|Extended pericardial drainage by catheter|Extended pericardial drainage will be done after pericardiocentesis by the insertion of a catheter to intermittently drain pericardial fluid till daily fluid return<30 ml.
16164819|NCT01665482|Other|A 2000 kcal test meal|
16266819|NCT00888446|Biological|tgAAC09|
16164820|NCT01665482|Other|A 2000 kcal test meal which accounts for 7% fat exchange with carbohydrate|
16164821|NCT01665469|Dietary Supplement|Tomato extracted lycopene|
16164822|NCT01665469|Dietary Supplement|Placebo|
16164823|NCT01665430|Drug|Tocilizumab|Tocilizumab will be administered at 8 mg/kg intravenous infusion every 4 weeks, up to 104 weeks.
16164824|NCT01665417|Drug|Experimental|Icotinib: 125mg, oral administration, three times per day.
16164825|NCT01665417|Drug|Chemotherapy|Chemotherapy Regimen 1：Pemetrexe 500 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.
16164826|NCT01665417|Drug|Chemotherapy|Chemotherapy Regimen 2：Docetaxel 75 mg/m^2 on Day 1, Cisplatin 75 mg/m^2 on Day 1, 21 days/1 cycle, 2/4 cycles totally, until progression, withdrawal of consent, or unacceptable toxicity.
16164827|NCT01665404|Drug|Fluvoxamine|Multiple doses of fluvoxamine
16164828|NCT01665404|Drug|RO4917523|Single dose of RO4917523
16164829|NCT01665391|Drug|fresolimumab|1 mg/kg total body weight administered intravenous (IV)
16164830|NCT01665391|Drug|fresolimumab|4 mg/kg total body weight administered intravenous (IV)
16164831|NCT01665391|Drug|Placebo|Placebo administered to match active treatment group
16164832|NCT01665378|Dietary Supplement|Multiple Micronutrient|"There is no current recommendation for weekly MM supplements for WRA. Therefore, we propose a supplement that contains: The same amounts of iron and folic acid as the weekly, pre-natal IFA supplement; An amount of vitamin D based on the Food and Nutrition Board's Recommended Daily Allowances (RDA); UNICEF/WHO/UNU recommended amounts of remaining nutrients (UNIMMAP recommendations). The supplement is taken weekly during pre-pregnancy.
~Vitamin A (μg) 800 Vitamin D (IU) 600 Vitamin E (mg) 10 Vitamin C (mg) 70 Thiamine (mg) 1.4 Riboflavin (mg) 1.4 Niacin (mg) 18 Vitamin B6 (mg) 1.9 Vitamin B12 (μg) 2.6 Folic acid (μg)* 2800 Iron (mg)* 60 Zinc (mg) 15 Copper (mg) 2 Selenium (μg) 65 Iodine (μg) 150"
16164833|NCT01665378|Dietary Supplement|Iron and Folic Acid|The doses of weekly and daily iron (60mg) and folic acid (2800μg) are based on current WHO recommendations for WRA.
16164834|NCT01665378|Dietary Supplement|Folic Acid|It is unethical to have a placebo group as FA is universally recommended for WRA to prevent neural tube defects. Therefore, the control group will receive 2800 μg FA once a week during the pre-pregnancy period. This dosage is safe and meets the minimum recommended intake of 400 μg/d for Women of Reproductive Age (WRA). Recent studies have shown that a weekly dose of 2800 μg FA is as effective as a daily dose of 400 μg in improving folic acid and reducing homocysteine levels among WRA.
16164835|NCT01665365|Procedure|Remote ischemic perconditioning|Intermittent arm ischemia through four cycles of 5-min inflation and 5-min deflation of a blood-pressure cuff started in the ambulance before admission to primary percutaneous coronary intervention.
16164836|NCT01665352|Drug|TTP054|Administered orally once daily for 12 weeks.
16164837|NCT01665352|Drug|Placebo|Administered orally once daily for 12 weeks.
16164838|NCT01665339|Other|preload diet|All participants were prescribed a calorie-restricted diet (-200 to -500 kcal/d). Calorie requirements of each subject were estimated based on resting energy expenditure (REE) by using Harris- Benedict equation and also considering the physical activity levels. The diets were constructed to provide similar proportions of carbohydrates (55% energy), protein (15% energy) and total fat (30% energy).
16164839|NCT01665339|Other|control diet|All participants were prescribed a calorie-restricted diet (-200 to -500 kcal/d). Calorie requirements of each subject were estimated based on resting energy expenditure (REE) by using Harris- Benedict equation and also considering the physical activity levels. The diets were constructed to provide similar proportions of carbohydrates (55% energy), protein (15% energy) and total fat (30% energy).
16164840|NCT01665326|Other|Observational|This is a longitudinal study focused on the emerging natural history of Infantile Pompe disease, response to ERT using alglucosidase alfa (Myozyme) and response to Immune Tolerance Induction (ITI).
16164841|NCT01665274|Drug|Capecitabine|Capecitabine 1,000 mg/m² twice daily, d1-14, q3w
16164842|NCT01665274|Drug|Oxaliplatin|Oxaliplatin IV infusion, 130mg/m² d1, q3w
16164843|NCT01665274|Procedure|D2 resection|D2 resection
16164844|NCT01665248|Other|18-F Sodium Fluoride Uptake in Positron emission tomography|
16164845|NCT01665235|Drug|Amlodipine|The amlodipine - based antihypertensive treatment group (you can add a diuretic or other )
16164846|NCT01665235|Drug|ACEI / ARB|ACEI / ARB -based antihypertensive treatment group ( you can add the B - blockers or other)
16164847|NCT01665235|Drug|Aspirin or Clopidogrel|aspirin 100mg / d or Clopidogrel 75mg / d (anti-platelet agents)
16164848|NCT01665235|Drug|Atorvastatin|Atorvastatin 10 - 40mg / d ( statin therapy)
16164849|NCT01665222|Drug|Morphine Sulfate|Morphine Sulfate 60mg Extended-release tablets
16164850|NCT01665209|Drug|Morphine Sulfate|Morphine Sulfate 60mg Extended-release tablets
16164851|NCT01665196|Drug|18F-FDG|Intravenous injection of single dose of 18F-FDG before treatment and after 4-week treatment, respectively.
16164852|NCT01665183|Drug|ADI-PEG 20|
16164853|NCT01665170|Drug|Passiflora incarnata|3 x 1 tablet per day for 3 days
16164854|NCT01665170|Drug|Placebo|3 x 1 ablet per day for 3 days
16164855|NCT01665157|Dietary Supplement|Enimaclin®|"Enimaclin Colomil ® (Glico Co., Japan Osaka)，a low-residue diet package for each meal.
~The duration of study is one day before colonoscopy."
16164856|NCT01665157|Other|Self-controlled diet|Self-controlled low residue diet.
16164857|NCT01665157|Drug|2L PEG-ELS|Normal volume of PEG-ELS
16164858|NCT01665157|Drug|low volume 1.5L PEG-ELS|Low volume PEG-ELS
16164861|NCT01665131|Device|Cameron Health S-ICD SQ-RX|
16164862|NCT01665118|Device|Trusculpt (Radio Frequency) Device|
16164863|NCT01665105|Device|acupuncture|electroacupuncture at at Zusanli, electroacupuncture at Yanglingquan, and acupuncture at non-acupoint.
16164864|NCT01665092|Drug|Levo-Carnitine|
16164865|NCT01665092|Drug|placebo|
16164896|NCT01664910|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo allogeneic PBSC transplant
16164897|NCT01664910|Biological|Rituximab|Given IV
16164898|NCT01664910|Drug|Tacrolimus|Given IV or PO
16164899|NCT01664897|Drug|Erlotinib Hydrochloride|Given PO
16164866|NCT01665079|Drug|Propofol|Propofol was administered by plasma TCI and a bolus dose was given by setting the initial plasma target between 12-16 μg/ml according to the anesthesiologist criteria. The protocol target range was selected based on previous experience using this model in the obese. After the patients reached this target, propofol infusion was stopped until the patients woke up (BIS>75). No other drugs were given during this period. Facemask ventilation was assisted only if necessary to maintain SpO2 > 90%. BIS data and propofol infusion data were automatically recorded every five seconds using the AnestFusor© program. Arterial blood samples of 4 ml for propofol assays were collected at 1, 2, 3, 5, 7 and 10 minutes after the initial bolus dose or until BIS > 75. After the patient woke up the study was considered finished and propofol infusion was restarted according to the anesthesiologist plan.
16164867|NCT01665066|Other|Own Brand cigarette|Smoke, 15 puff of, Own Brand cigarettes;
16164868|NCT01665066|Other|one high 2,4% nicotine|Smoke, 25 puff, of electronic cigarette one high 2,4% nicotine
16164869|NCT01665066|Other|original 7,4 mg nicotine|Smoke, 15 puff, of Categoria electronic cigarette 7,4 mg nicotine
16164870|NCT01665066|Other|nicotine free|smoke, 15 puff, of electronic cigarette nicotine free
16164871|NCT01665066|Other|Ego 9mg|smoke, 15 puff, of electronic cigarette Ego 9 mg
16164872|NCT01665053|Device|PROMUS Element Plus|A drug eluting coronary stent system
16164873|NCT01665053|Device|SYNERGY|A drug eluting coronary stent system
16164874|NCT01665040|Device|Neurostimulation device implantation|"Study subjects will undergo a screening-trial of neurostimulation using the Boston Scientific Corporation Precision Spectra neurostimulation system and may proceed to permanent implantation in the event of a successful screening trial.
~Treatment will include spinal cord stimulation and may also include peripheral nerve stimulation, based upon the physician's subject-specific treatment plan."
16164875|NCT01665027|Procedure|vacuum|"Vacuum is an instrument that is using for helping delivery when there is no possibility of spontaneous delivery. First report of using vacuum was in 1962 by Solomon for delivery of fetal head (12). He suggested that using this instrument will lower pressure on fetal head and decrease delivery time (and then decrease fetal hypoxemia). Also it decreases spreading of incision and vascular injury (during manual maneuvers). Some studies confirmed these results (13, 14) and some others disagreed it (15, 16).
~Considering with importance of fetal head delivery in a short time during C/S and to decrease maternal complications like lacerations and vascular injuries, this study was designed to compare the results of delivery by vacuum in C/S with routine methods for head extraction during difficult caesarean sections."
16164876|NCT01665027|Procedure|routine manual maneuvers for fetal head extraction|fetal head techniques like fundal pushing, pulling technique or reverse breech extraction
16164877|NCT01665014|Radiation|Total marrow irradiation|Mobilization of stem cells with the use of cytarabine 1.6 g/m2 followed by filgrastim 480 ug/d. Conditioning for the 1st autoHSCT: total marrow irradiation 4 Gy on days -3,-2,-1 (total 12 Gy). Conditioning for 2nd autoHSCT performed 3-4 months after the 1st one: melphalan 100 mg/m2 on days -2,-3 (total 200 mg/m2)
16164878|NCT01665001|Other|Treatment strategy: induction, consolidation, HSCT, maintenance|"Patients <55 years Ph-neg.: induction (daunorubicin, prednisone, vincristin, PEG-asparaginase), 2nd induction (if non-remission or MRD>0.1%; FLAM, MiniFLAM or FLAM-CAMP dependent on age and phenotype), consolidation (methotrexate, etoposide, cytarabine, cyclophosphamide, PEG-asparaginase). If MRD <0.01%: autoHSCT + maintenance (mercaptopurine, methotrexate) or multiagent maintenance (additionally daunorubicin, vincristin, prednisone); remaining patients: alloHSCT. Prophylaxis of leptomeningeal involvement: liposomal cytarabine intrathecally.
~Patients >55 years, Ph-neg.: as above, reduced doses. AlloHSCT with reduced conditioning.
~Patients Ph-pos.: as above, reduced doses in combination with continues imatinib. All intended for alloHSCT."
16164879|NCT01664988|Behavioral|muscular relaxation|muscular relaxation was done using Jacobson by contracting and relaxing selected groups of muscles until total relaxation
16164880|NCT01664988|Behavioral|breath control|breathing control techniques include deep diaphragmatic breathing and decrease breath rate to 6-10/min
16164881|NCT01664988|Other|control (routine care)|received routine care of clinic or health center and use drugs if necessary
16164882|NCT01664975|Drug|GDPT regimen|GDPT regimen(Gemcitabine,Cisplatin,Prednisone ,Thalidomide) Cisplatin(DDP) 25 mg/m2,ivgtt（intravenously guttae）,d1-3;Prednisone 60mg/m2,p.o,d1-5;Gemcitabine(GEM) 800mg/m2,ivgtt,30min,d1,8;Thalidomide,p.o,200mg/d,Continued use to the end of chemotherapy .Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles.
16164883|NCT01664975|Drug|CHOP regimen|CHOP regimen(Cyclophosphamide,Vincristine,Doxorubicin,Prednisone) Cyclophosphamide 750mg/d,ivgtt, d1;Vincristine,1.4g/m2,ivgtt, d1;Doxorubicin,50mg/m2,ivgtt,d1;Prednisone 60mg/m2,p.o, d1-5.
16164884|NCT01664949|Drug|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.
16164885|NCT01664949|Drug|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.
16164886|NCT01664936|Radiation|Cerenkov emissions from the PET tracer 18F-FDG and the radiotherapeutic 131I|We will image (i) patients who are receiving a PET/CT scan for tumors in the head / neck region and (ii) patients with thyroid cancer after 131I radioablation. Two scans will be completed per patient, one of the primary tumors, as well as a 'background' scan of the contralateral side or, if tumor is there as well, of the forearm. The device to be used is an intensified charge-coupled device camera (Stanford Photonics, Palo Alto, CA) connected to a laptop PC. The camera will use a Quartz high-UV transmission 50 mm 0.8f lens. The Imaging device will be placed approximately 5 cm from the area of the patient to be imaged.
16164887|NCT01664923|Drug|Enzalutamide|160 mg, daily, by mouth.
16164888|NCT01664923|Drug|Bicalutamide|50 mg, daily, by mouth
16164889|NCT01664910|Procedure|Allogeneic Bone Marrow Transplantation|Undergo allogeneic BM transplant
16164890|NCT01664910|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic PBSC or BM transplant
16164891|NCT01664910|Biological|Anti-Thymocyte Globulin|Given IV
16164892|NCT01664910|Drug|Bendamustine Hydrochloride|Given IV
16164893|NCT01664910|Drug|Fludarabine Phosphate|Given IV
16164894|NCT01664910|Biological|Inotuzumab Ozogamicin|Given IV
16164895|NCT01664910|Drug|Methotrexate|Given IV
16164900|NCT01664897|Other|Laboratory Biomarker Analysis|Correlative studies
16164901|NCT01664871|Device|DIammine SIlver Fluoride|Concentrations of Silver and Fluoride in the DSF used for study were 24.9% and 5.5%, respectively Average total weight (calculated volume) of Diammine Silver Fluoride applied was 7.57 mg (6.04 µL), corresponding to a mean application of 0.33 mg Fluoride based on the lot analysis. The mean total amount of Silver applied to the 3 teeth was 1.50 mg.
16164902|NCT01664858|Other|3T CMR|3Tesla Cardiac Magnetic Resonance Imaging
16164903|NCT01664858|Other|SPECT|SPECT: Single Photon Emission Computed Tomography
16164904|NCT01664858|Other|CT calcium score|CT calcium score
16164905|NCT01664858|Other|CT coronary angiography|CT coronary angiography
16164906|NCT01664858|Other|X-Ray coronary angiography|X-Ray coronary angiography
16164907|NCT01664845|Drug|metformin|metformin 500mg tid
16164908|NCT01664845|Drug|pegylated-IFN|pegasys 180 mcg qw
16164909|NCT01664845|Drug|ribavirin|ribavirin 800-1200 mg qd according to BW
16164910|NCT01664832|Device|S-nIMV|Synchronization of nasal breaths to infant's own respiratory effort
16164911|NCT01664819|Dietary Supplement|Antioxidant|
16164912|NCT01664819|Dietary Supplement|Placebo|
16164913|NCT01664806|Device|Covidien Triad monopolar generator|Blend mode (triverse pencil valleylab mode) 30 Watts will be used to perform a laparoscopic cholecystectomy.
16164914|NCT01664793|Behavioral|4 Pillars Immunization Toolkit|Pillar 1: Convenient Vaccination Services; Pillar 2: Patient notification about the importance of vaccination and availability of convenient services; Pillar 3: Enhanced Office Systems; Pillar 4: Motivation: Office immunization champion tracks progress towards a goal; Early delivery of donated vaccines for disadvantaged children, staff education, support of effort by research staff.
16164915|NCT01664780|Device|ARFI imaging|
16164916|NCT01664767|Other|Sulfur Thermal water|
16164917|NCT01664767|Other|Placebo|
16164918|NCT01664754|Drug|exemestane|Given PO
16164919|NCT01664754|Drug|pemetrexed disodium|Given IV
16164920|NCT01664754|Drug|carboplatin|Given IV
16164921|NCT01664754|Other|laboratory biomarker analysis|Correlative studies
16164922|NCT01664754|Other|pharmacological study|Correlative studies
16164923|NCT01664754|Other|questionnaire administration|Ancillary studies
16164924|NCT01664754|Procedure|quality-of-life assessment|Ancillary studies
16164925|NCT01664741|Drug|Nicotine patch - transdermal|21 mg patch
16164926|NCT01664741|Drug|placebo|
16164927|NCT01664728|Drug|Abiraterone acetate|Phase 2 maximum tolerated dose from Study COU-AA-001 taken orally once daily
16164928|NCT01664728|Drug|Glucocorticoid|prednisolone/prednisone 5 mg taken orally twice daily or dexamethasone 0.5 mg taken orally once daily
16164929|NCT01664715|Behavioral|150 Min/Week|Performs 150 min/wk of planned moderate intensity aerobic exercise.
16164930|NCT01664715|Behavioral|225 Min/Week|Performs 225 min/wk of planned moderate intensity aerobic exercise.
16164931|NCT01664715|Behavioral|300 Min/Week|Performs 300 min/wk of planned moderate intensity aerobic exercise.
16164932|NCT01664702|Dietary Supplement|Dairy Products|See the effect dairy product has on fat oxidation in overweight individuals expending the same amount of energy
16164933|NCT01664702|Dietary Supplement|Dairy Servings|Continue baseline consumption of one or fewer servings of dairy per day
16164934|NCT01664689|Procedure|Microcoaxial Phacoemulsification|
16164935|NCT01664676|Drug|Liraglutide|
16164936|NCT01664676|Drug|Placebo-liraglutide|
16164937|NCT01664663|Radiation|Standard radiochemotherapy to 68 Gy|
16164938|NCT01664663|Radiation|Dose escalated radiochemotherapy up to 84 Gy|
16164939|NCT01664650|Dietary Supplement|Genistein|
16164940|NCT01664650|Dietary Supplement|Placebo|
16164941|NCT01664637|Drug|10 mg TZP-102|One oval-shaped, opaque-white, hard gelatin capsule containing active ingredient will be taken orally three times a day for 12 weeks
16164942|NCT01664637|Drug|Placebo|One oval-shaped, opaque-white, hard gelatin capsule of placebo indistinguishable from active drug will be taken orally three times a day for 12 weeks
16164943|NCT01664624|Drug|Roflumilast|Roflumilast tablets
16164944|NCT01664624|Drug|Alogliptin|Alogliptin tablets
16164945|NCT01664624|Drug|Exenatide|Exenatide solution
16164946|NCT01664624|Drug|Placebo to roflumilast|Placebo-matching roflumilast tablets
16164947|NCT01664624|Drug|Placebo to alogliptin|Placebo-matching alogliptin tablets
16164948|NCT01664611|Procedure|Remote Ischaemic Conditioning administered via the inflation of a blood pressure cuff on the upper arm|Suprasystolic blood pressure cuff inflation for set periods to time to render a limb ischaemic followed by periods of deflation to allow for reperfusion.
16164949|NCT01664611|Procedure|Sham conditioning|Non therapeutic inflation of a blood pressure cuff that does not cause ischaemia/reperfusion injury
16164950|NCT01664598|Drug|tocilizumab [RoActemra/Actemra]|8 mg/kg iv every 4 weeks, 104 weeks
16164951|NCT01664585|Behavioral|Training group|The 60-minute training sessions include a few mobilization techniques for upper neck. In detail, three different exercises concentrated on postural and motor control will be taught during the first two training sessions. Progressively, two additional exercise movements aiming at postural and motor control will be taught in the next session. After eight weeks, two muscle strength exercises utilising therapeutic rubber band will be included into the program. The aim of the rubber band exercises is eventually to achieve the load of 80% of maximal voluntary contraction. The participants in the training group are also instructed to increase their amount of physical activity progressively according to the current physical activity recommendations.
16164952|NCT01664585|Behavioral|Control|The control group will receive six sessions of Transcutaneous Nervous Stimulation treatment (TNS) as a placebo treatment (0) and the participants in control group are recommended and encouraged to maintain their previous normal level of physical activity and exercise habits throughout the study without any supervision or home training programs.
16164953|NCT01664559|Drug|Ketorolac|Ketorolac 30mg intramuscular injection, 1cc volume
16164954|NCT01664559|Drug|Normal Saline|Placebo arm, 1cc of normal saline, 0.9%, intramuscular injection
16164955|NCT01664546|Procedure|Trophectoderm biopsy|
16164956|NCT01664533|Drug|Erlotinib|Erlotinib was supplied as tablets in the retail product Tarceva.
16165045|NCT01663623|Biological|Placebo|Placebo
16164957|NCT01664520|Drug|Dexmedetomidine infusion|"Both static and dynamic autoregulation are assessed first during propofol infusion, before commencement of dexmedetomidine infusion. Dexmedetomidine infusion is commenced with a dose of 0.7 μg/kg/h and propofol infusion is stopped concomitantly. After 2 hours dexmedetomidine infusion, the static and dynamic autoregulation are assessed. If there are no signs of worsening of autoregulation, then the dexmedetomidine infusion is increased to 1 μg/kg/h and after 2 hours the static and dynamic autoregulation are assessed again. However, if autoregulation worsens during dexmedetomidine infusion, it will be stopped and further testing with dexmedetomidine will not be carried out. If autoregulation does not worsen with the 1 μg/kg/h dose then the dose will be increased to 1.4 μg/kg/h. After 2 hours infusion the dynamic and static autoregulation are assessed again.
~Blood samples for determining dexmedetomidine plasma concentration are collected alongside with the autoregulation assessments"
16164958|NCT01664507|Drug|conventional dose epinephrine|conventional dose epinephrine : 0.5mg/kg + 0.9% normal saline
16164959|NCT01664507|Drug|low dose epinephrine|low dose epineprhine : 0.1mg/kg + 0.9% normal saline
16164960|NCT01664494|Drug|Capecitabine|Capecitabine will be given according to the label text as monotherapy (1250 mg/m^2 twice daily) or combination therapy (800 to 1000 mg/m^2 or 1250 mg/m^2 twice daily) for 14 consecutive days followed by a treatment break of 7 days.
16164961|NCT01664273|Drug|Plasmid AMEP|"Cohorts of 3 patients will received increasing doses of plasmid AMEP:
~50 μg, 100 μg, 250 μg and 500 μg. Starting dose will be the lowest dose.
~Injection volume will remain constant at 200 μL.
~Once-only treatment and intra-individual dose escalation will therefore not occur."
16164962|NCT01664260|Drug|N-acetylcysteine|0 - 8 week: 10 mg escitalopram a day + 1200 mg N-acetylcysteine twice a day
16164963|NCT01664260|Drug|Placebo|0 - 8 week: 10 mg escitalopram a day + 1200 mg Placebo twice a day
16164964|NCT01664247|Drug|insulin degludec|Administered s.c. (under the skin) once daily. Dose individually adjusted.
16164965|NCT01664247|Drug|placebo|Administered s.c. (under the skin) once daily. Dose individually adjusted.
16164966|NCT01664247|Drug|liraglutide|Administered s.c. (under the skin) once daily. Dose: 1.8 mg.
16164967|NCT01664234|Other|laryngoscopy with oxygen|Patients will be randomly assigned to laryngoscopy with or without simultaneous insufflation of oxygen at 4 L/minute. Oxygen will be provided by a flowmeter connected via rigid tubing to the track-mounted endotracheal tube on the AirTraq.
16164968|NCT01664234|Other|laryngoscopy without oxygen|Patients will be randomly assigned to laryngoscopy without simultaneous insufflation of oxygen at 4 L/minute.
16164969|NCT01664221|Drug|Epoetin Alfa|Intravenous administration of the drug, test or comparator, for 4 weeks, 3 times a week (monday, wednesday and friday).
16164970|NCT01664195|Drug|Epoetin Alfa|Intravenous single-dose administration of 100 IU/kg of the test drug (Eritromax) in the first period and intravenous single-dose administration of 100 IU/kg of the comparator drug (Eprex) in the second period, after 23-30 days of washout, or vice-versa.
16164971|NCT01664182|Biological|Bevacizumab|Given IV
16164972|NCT01664182|Drug|Pazopanib Hydrochloride|Given PO
16164973|NCT01664182|Drug|Sorafenib Tosylate|Given PO
16164974|NCT01664182|Drug|Sunitinib Malate|Given PO
16164975|NCT01664182|Biological|Trebananib|Given IV
16164976|NCT01664169|Other|laboratory biomarker analysis|
16164977|NCT01664156|Drug|Korean red ginseng|Korean red ginseng is a steamed form of Panax ginseng with preserved major constituents. It has been shown to possess more biological activity than panax ginseng.
16164978|NCT01664156|Drug|Placebo|
16164979|NCT01664143|Drug|Placebo|Multiple doses of placebo
16164980|NCT01664143|Drug|RO5508887|Multiple doses of RO5508887
16164981|NCT01664130|Radiation|stereotactic body radiation therapy|Undergo SBRT
16164982|NCT01664130|Procedure|quality-of-life assessment|Ancillary studies
16164983|NCT01664130|Other|laboratory biomarker analysis|Correlative studies
16164984|NCT01664104|Drug|Tocilizumab|Tocilizumab will be administered in routine clinical practice in accordance with local label. Study protocol does not specify/enforce any treatment regimen.
16164985|NCT01664091|Radiation|post-mastectomy radiation therapy (PMRT)|
16164986|NCT01664091|Device|tissue expander (TE)|
16164987|NCT01664091|Device|acellular dermal matrix (ADM)|
16164988|NCT01664078|Device|Endovascular AAA repair with InCraft®|
16164989|NCT01664065|Drug|200 mg Ceftaroline fosamil|1 h infusion
16164990|NCT01664065|Drug|600 mg Ceftaroline fosamil|1 h infusion
16164991|NCT01664052|Device|ESS505 (Essure, BAY1454033)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
16164992|NCT01664052|Device|ESS305 (Essure, BAY1454032)|Unilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert inclusive of polyethylene terephthalate (PET) fibers (investigational device model ESS505) and contralateral placement of the current commercially approved Essure device, model ESS305 followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement. At the conclusion of the hysterectomy, the uterine cornua and fallopian tubes were sent to a pathology lab for histological preparation, and subsequent evaluation.
16164993|NCT01664052|Device|ESS505-A (Essure, BAY1454033)|Bilateral hysteroscopic placement of the permanent birth control system, Model ESS505 insert with minimal polyethylene terephthalate (PET) fibers (investigational device model ESS505-A) followed by tubal occlusion evaluation by hysterosalpingogram (HSG) approximately 60 minutes following insert placement. A subsequent HSG was performed prior to the subjects' scheduled hysterectomy procedures at 30 (group 3), 60 (group 2) or 90 days (group 1) post insert placement.
16164994|NCT01664039|Drug|Travoprost 0.004% ophthalmic solution|Ophthalmic solution without benzalkonium chloride (BAK), containing Polyquad® preservative
16164995|NCT01664039|Drug|Bimatoprost 0.01% ophthalmic solution|Ophthalmic solution containing benzalkonium chloride (BAK)
16164996|NCT01664026|Behavioral|Web-based lifestyle modification|Access to a web-based lifestyle modification program of 6-month duration that covers all aspects of a healthy lifestyle including physical activity, nutrition and weight maintenance.
16164997|NCT01664026|Behavioral|Web-based lifestyle modification +|Access to a web-based lifestyle modification program of 6-month duration that covers all aspects of a healthy lifestyle including physical activity, nutrition and weight maintenance plus telephone counseling support by health coaches on a weekly or bi-weekly basis.
16164998|NCT01664013|Drug|Nuronox|Reconstituted Neuronox® is injected at a dose determined by the physician based upon his/her clinical experience with botulinum toxin.Actual dose and injection site should be adjusted individually considering the muscle mass, degree of spasticity, body weight, and response to any previous botulinum toxin injections.
16164999|NCT01664000|Drug|thioureidobutyronitrile|Kevetrin (thioureidobutyronitrile)
16165000|NCT01663987|Drug|tiotropium bromide|18 mcg once a day (QD)
16165001|NCT01663987|Drug|Placebo|once a day (QD)
16165002|NCT01663961|Drug|YM178 OCAS|oral
16165003|NCT01663961|Drug|Digoxin|oral
16165004|NCT01663935|Drug|Levodopa/carbidopa|This study will have an intent to treat goal. Anyone that fits the inclusion criteria for the study will be entered and receive study drug.
16165005|NCT01663922|Drug|Boceprevir|Boceprevir as Victrelis(r) 200mg capsules
16165006|NCT01663922|Drug|St John's Wort|Each Ucalm(r) tablet contains 300mg of St Johns Wort extract
16165007|NCT01663909|Behavioral|Guided imagery intervention|A 30-min DVD was developed which included general information on pain management as well as a section on guided imagery using sounds and images.
16165008|NCT01663896|Device|OCT stent guidance|Participants undergoing pre- and post-PCI fractional flow reserve (FFR) and OCT
16165009|NCT01663883|Other|Isometric exercise|use of a handgrip for 3x2 minutes
16165010|NCT01663870|Behavioral|Audio Recorded Interviews|Audio recorded interview at beginning of visit and after using HealthATM website.
16165011|NCT01663870|Behavioral|Focus Group Session|Focus group session taking 60-90 minutes.
16165012|NCT01663870|Other|Website Session|10-15 minute session with the HealthATM website.
16165013|NCT01663870|Behavioral|Questionnaire|Questionnaire completion at end of audio recorded interview taking about 5 minutes.
16165014|NCT01663857|Drug|LY2228820|Administered Orally
16165015|NCT01663857|Drug|Carboplatin|Administered IV
16165016|NCT01663857|Drug|Placebo|Administered Orally
16165017|NCT01663857|Drug|Gemcitabine|Administered IV
16165018|NCT01663844|Behavioral|Therapist guided Internet-CBT for insomnia w. extra support|(Study 2) A 9 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for insomnia plus extra therapist support.
16165019|NCT01663844|Behavioral|Therapist guided Internet-CBT for insomnia|(Study 2) A 9 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for insomnia. Regular therapist support.
16165020|NCT01663844|Behavioral|Therapist guided Internet-CBT for insomnia and depression|(Study 1) A 12 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for insomnia and depression.
16165021|NCT01663844|Behavioral|Therapist Guided Internet-CBT for depression plus insomnia placebo|(Study 1) A 12 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for depression. A placebo intervention for insomnia is added.
16165022|NCT01663831|Other|Mosquito topical repellent|Daily repellent use, before and after sleeping hours during the malaria season (6 months) in addition to the use of Long Lasting Insecticidal Nets during sleeping hours.
16165023|NCT01663818|Device|Tack-It Endovascular Stapler|
16165024|NCT01663805|Drug|Everolimus|Everolimus is started immediately after transplantation, the dosage of 1.5 mg twice a day, adjusted to achieve and maintain the blood level of 3-8 ng/mL.
16165025|NCT01663792|Other|Seaweed|Ten 500-mg capsules to be taken orally each day for 1 month
16165026|NCT01663792|Other|Placebo|Ten 500-mg capsules to be taken orally each day for 1 month
16165027|NCT01663792|Other|Placebo2|Ten 500-mg capsules to be taken orally each day for 1 month
16165028|NCT01663779|Procedure|Ultrasound guided radial artery catheterization.|Radial artery catheters will be placed with the assistance of bedside ultrasound.
16165029|NCT01663779|Procedure|Blind insertion of radial artery catheterization|Radial artery catheters will be placed by the palpation technique only.
16165030|NCT01663766|Drug|milatuzumab|Milatuzumab is a humanized anti-CD74 antibody that is administered intravenously.
16165031|NCT01663753|Device|18F-FDG-PET|
16165032|NCT01663740|Drug|Valganciclovir|Participants will receive valganciclovir 900 milligrams (mg) orally once daily for up to a maximum of 200 days post-transplant.
16165033|NCT01663727|Drug|Bevacizumab [Avastin]|Intravenous repeating dose
16165034|NCT01663727|Drug|Paclitaxel|Intravenous repeating dose
16165035|NCT01663727|Drug|Placebo|Intravenous repeating dose
16165036|NCT01663714|Biological|cycolophosphamide, vacristine, and pednisone (CVP) x6 cycles followed by tositumomab and iodine I 131 tositumomab.|cycolophosphamide, vacristine, and pednisone (CVP) x6 cycles followed by tositumomab and iodine I 131 tositumomab. CVP will be repeated every 21 days for a total of six cycles. tositumomab and iodine I 131 tositumomab will begin within 56 days following the first day of the sixth cycle of CVP. Patient will undergo two dosing phase for the tositumomab and iodine I 131 tositumomab therapy.
16165037|NCT01663701|Other|Simplified severe sepsis protocol|This protocol consists of an early aggressive fluid strategy, and, when appropriate, blood transfusion and titratable dopamine. Monitoring is based on physical exam findings.
16165038|NCT01663701|Other|Usual care|Patients are managed according to admitting doctors' orders
16165039|NCT01663675|Genetic|karyotype|
16165040|NCT01663662|Drug|Tolvaptan|
16165041|NCT01663662|Drug|placebo|
16165042|NCT01663649|Behavioral|Deprexis|web-based treatment program for depression
16165043|NCT01663649|Behavioral|Wait-list|the wait-list group receives Deprexis after 6 month
16165044|NCT01663636|Behavioral|SMS message reminding mothers to come for their scheduled vaccines|Reminder
16165047|NCT01663623|Drug|Azathioprine|Azathioprine
16165048|NCT01663610|Behavioral|VardagsSMART|VardagsSMART Internet-based course with therapist support during 6 weeks
16165049|NCT01663584|Procedure|Blood draw|
16165050|NCT01663558|Drug|imiquimod|
16165051|NCT01663558|Procedure|ablative|
16165052|NCT01663532|Drug|Aripiprazole IM Depot|
16165053|NCT01663532|Drug|Placebo|Matching Placebo
16165054|NCT01663519|Other|Custom made insoles 35 shore|Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast.
16165055|NCT01663519|Other|Prefabricated insoles|Prefabricated insoles
16165056|NCT01663519|Other|55 shore Custom made insole|Insoles in Ethyl Vinyl Acetate (EVA) manufactured over an individual positive cast.
16165057|NCT01663493|Procedure|FNB|
16165058|NCT01663467|Drug|Ginkgo biloba|Ginexin-F 80mg tablet will be given twice a day for 6 months.
16165059|NCT01663467|Behavioral|modified TRT|"modified TRT (tinnitus retraining therapy) using smartphone and web based materials will be added with Ginkgo biloba.
~Ginexin-F 80mg tablet will be given twice a day for 6 months."
16165060|NCT01663454|Behavioral|Cogmed Robomemo working memory training|The Cogmed Robomemo program is designed as a computer game in which an animated robot gives different tasks to be solved by the child. The tasks have various degrees of difficulty adapted continuously throughout the intervention period to the performance of the individual child. The program is standardized in that each child receives the same set of tasks during the training period. The child will perform the training sessions at home using their own computer for about 35-40 minutes each day.
16165061|NCT01663441|Drug|NL201|mIL-11:5μg/kg，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy；
16165062|NCT01663441|Drug|NL201|mIL-11:7.5μg/kg，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy；
16165063|NCT01663441|Drug|NL201|The optimal dosing dose NL201，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy.
16165064|NCT01663441|Drug|rhIL-11|rhIL-11(25μg/kg)，subcutaneous administration once daily for 10 days,beginning 24 h after chemotherapy.
16165065|NCT01663428|Other|Sup-ER Splint|
16165066|NCT01663428|Other|Currently accepted treatment|
16165067|NCT01663415|Drug|Enzalutamide|oral
16165068|NCT01663402|Drug|Alirocumab|Alirocumab administered as SC injection of 1 mL in the abdomen or thigh with a disposable auto-injector.
16165069|NCT01663402|Drug|Placebo|Placebo matched to alirocumab administered as a SC injection of 1 mL in the abdomen or thigh with a disposable auto-injector.
16165070|NCT01663402|Drug|LMT|Statins (atorvastatin or rosuvastatin) at stable maximal tolerated dose of statin with or without other LMT as clinically indicated.
16165071|NCT01663389|Drug|GSK1322322 1000 mg containing radioactive 14C-GSK1322322|GSK1322322 1000 mg is a mesylate salt powder for injection containing 45.5 μCi radioactive 14C-GSK1322322 1000 mg as free base.
16165072|NCT01663389|Drug|GSK1322322 1200 mg containing radioactive 14C-GSK1322322|GSK1322322 1200 mg is a mesylate salt powder for oral solution containing 54.5 μCi radioactive 14C-GSK1322322 1200 mg as free base.
16165073|NCT01663376|Procedure|Autologous Adipose Tissue derived MSCs Transplantation|Intramuscular injection of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e8 ~3x10e8 cells
16165074|NCT01663363|Device|LASIK correction of myopic refractive errors|Surgeons will perform wavefront-guided LASIK based upon measurement obtained with the iDesign System
16165075|NCT01663337|Behavioral|Cognitive Processing Therapy (CPT)|CPT is a highly structured course of therapy that focuses primarily on the cognitive restructuring of trauma related beliefs.
16165076|NCT01663337|Behavioral|Relapse Prevention (RP)|RP utilizes high-risk situation assessment/avoidance, drink refusal skills, assertiveness training,cognitive restructuring as well as other approaches to address issues of alcohol use/dependance.
16165077|NCT01663324|Device|rTMS intervention 1|"Low frequency rTMS (Magventure Mag Pro Option) applied over left temporoparietal cortex: 3000 stimuli of 1Hz rTMS (110% motor threshold); 1 minute break after 1000 and 2000 stimuli.
~Arms: single site rTMS"
16165078|NCT01663324|Device|rTMS intervention 2|"Repetitive transcranial magnetic stimulation (Magventure Mag Pro Option): 1000 stimuli of 20 Hz rTMS over the left DLPFC (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over the left temporoparietal cortex (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over right temporoparietal cortex (110% motor threshold).
~Arms: multisite rTMS"
16165079|NCT01663311|Device|Medial Frontal rTMS Double-Cone-Coil|High frequency rTMS ( Alpine Biomed Mag Pro Option) applied over medial superior frontal cortex (supplementary motor cortex) (Brodman area 6/8),Double-Cone-water-cooled-Coil (2000 Stimuli of 10 Hz each session), 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold.
16165080|NCT01663311|Device|Left DLPFC Butterfly Coil|High frequency rTMS ( Alpine Biomed Mag Pro Option): 2000 stimuli of 20 Hz over the left DLPFC (each session), Butterfly-water-cooled-Coil, 110% motor threshold; followed by: low frequency rTMS ( Alpine Biomed Mag Pro Option) applied over left temporoparietal cortex, Butterfly-water-cooled-Coil (2000 Stimuli of 1 Hz each session), 110% motor threshold.
16165081|NCT01663298|Procedure|Dental implant surgery|Surgery involving placement of one dental implant, of either Astra Tech or Straumann system, is performed in all subjects within 2 weeks of screening examination. Implant placement is 1-stage, but can be either on edentulous ridges or in extraction sockets.This is not a randomized treatment arm/group design. The study is observational with regards to the analysis of tissue samples that are collected prior to the routine placement of implants. The implant choice is based upon patient needs and is not related to any outcome.
16165082|NCT01663285|Drug|Neoadjuvant Cisplatin and Gemcitabine|Cisplatin 70 mg/m2 through IV for 60 minutes on day 1 of each cycle. Gemcitabine 1,000 mg/m2 IV for 30 minutes on days 1 and 8 during each cycle. Treatment is expected to continue for up to 4 cycles. Chemotherapy will be followed by radical nephroureterectomy within 6 weeks (+/- 2 weeks) from the last date of chemotherapy.
16165083|NCT01663272|Drug|CABOZANTINIB|Daily oral cabozantinib administered days -7 until disease progression, intolerable adverse event(s) or patient choice.
16165084|NCT01663272|Drug|gemcitabine|Gemcitabine administered intravenously on days 1, 8, and 15 every 28 days.
16165124|NCT01662908|Drug|warfarin|tablet for oral use; daily dosage, adjusted to maintain international normalized ratio (INR) between 2.0 and 3.0; 90 days treatment.
16165085|NCT01663259|Drug|Cetuximab|Before Radiotherapy patients you will receive a single loading dose of cetuximab. Patients will also have two additional biopsies before and after cetuximab to determine how the tumor is affected. A Cetuximab infusion will also be delivered once a week during radiotherapy.Radiation will be started (70 Gy in 35 fractions over 7 weeks to the gross tumor, 50-60 Gy to subclinical target volumes) five days a week until the total dose of radiation prescribed by the doctor is reached. Radiation will be delivered concurrent with weekly cetuximab 250 mg/m2, delivered on Monday or Tuesday each week. In order to evaluate swallowing problems from radiotherapy, patients will undergo an evaluation of swallowing by videofluoroscopy (VF). Quality of Life questionnaires will be given before therapy and periodically up to 36 months after therapy. In order to assess if the tumor was completely eradicated, CT-PET scan will be performed 3 months after the completion of therapy.
16165086|NCT01663259|Radiation|Radiotherapy|Radiation will be started (70 Gy in 35 fractions over 7 weeks to the gross tumor, 50-60 Gy to subclinical target volumes) five days a week until the total dose of radiation prescribed by the doctor is reached. Radiation will be delivered concurrent with weekly cetuximab 250 mg/m2, delivered on Monday or Tuesday each week.
16165087|NCT01663246|Procedure|Saliva Sample|Small plastic cups will be placed on the inside of subject cheeks, and held in place with gentle suction. These cups are attached to tubes which will allow the collection of saliva into a test tube. Saliva will also be collected from the glands underneath the tongue using a small gentle suction device, similar to the one used by a dentist. Saliva production will be stimulated by dabbing a mild citric acid solution that tastes like lemon onto the tongue using a Q-Tip. After this test, subjects will also be asked to chew wax to simulate saliva, and the saliva that accumulates in their mouth will be collected by spitting into a test tube.
16165088|NCT01663233|Drug|LCZ696|LCZ696 will use tablets available at a strength of 200mg. Patients will be instructed to take the prescribed medication once a day.
16165089|NCT01663233|Drug|Amlodipine|Amlodipine will use tablets available at a strength of 5 mg. Patients will be instructed to take the prescribed medication once a day.
16165090|NCT01663233|Drug|Placebo|Matching placebo to LCZ696
16165091|NCT01663194|Procedure|primary percutaneous coronary intervention, each groups|All primary PCI procedures were performed using the standard femoral approach with a 7-French guiding catheter for each patients. After administration of 5,000 IU of intravenous heparin (70 U/Kg) and a 300 mg loading dose of clopidogrel, direct stenting was performed whenever possible, and in the remaining cases, balloon pre-dilatation was performed. The operator determined the choice of stents (bare metal or drug-eluting stent).
16165092|NCT01663168|Drug|Rifabutin|
16165093|NCT01663155|Device|chest x-ray with or without CAD, lose dose CT scan|PA view, low dose CT scan
16165094|NCT01663116|Genetic|Stem cells|"first cohort: 1 million stem cells/kg administered at days 1, 8 and 15
~second cohort: 2 million stem cells / kg administered at days 1, 8 and 15
~third cohort: 4 million stem cells / kg administered at days 1, 8 and 15"
16165095|NCT01663116|Genetic|Placebo|"first cohort: 20 ml administered at days 1, 8 and 15
~second cohort: 40 ml administered at days 1, 8 and 15
~third cohort: 80 ml administered at days 1, 8 and 15"
16165096|NCT01663103|Drug|Rilonacept|12 weeks of treatment with rilonacept (subcutaneous injection with a loading dose of 320 mg, followed by 160 mg/wk)
16165097|NCT01663103|Drug|Placebo|Twelve weeks of treatment with placebo (subcutaneous injection of normal saline with a loading dose of 320 mg, followed by 160 mg/wk)
16165098|NCT01663090|Drug|Ferumoxytol|
16165099|NCT01663077|Drug|Clozapine|A fixed dose of Clozapine 300 mg/day (150 mg x 2)for 3 month
16165100|NCT01663064|Device|Endovascular treatment (Zenith® p-Branch™ endovascular graft)|Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
16165101|NCT01663051|Device|Zilver Vena Venous Stent|Stenting iliofemoral venous outflow obstruction
16165102|NCT01663038|Drug|Clopidogrel|Clopidogrel and Aspirin separate combination, single dose
16165103|NCT01663038|Drug|Fixed dose combination of clopidogrel/Aspirin|Fixed dose combination of clopidogrel/aspirin
16165104|NCT01663038|Drug|Aspirin|
16165105|NCT01663025|Behavioral|Hand Reflexology|The hand reflexology will begin in theatre, before the local anaesthetic is administered and will continue until the patient is ready to leave the operating theatre.
16165106|NCT01663012|Drug|Etirinotecan pegol|
16165107|NCT01662999|Drug|Saxagliptin|
16165108|NCT01662999|Drug|Dapagliflozin|
16165109|NCT01662986|Drug|tiotropium bromide|18 mcg once a day (QD)
16165110|NCT01662986|Drug|Placebo|Once a day (QD)
16165111|NCT01662973|Other|conventional plus UC-MSC treatment|Received conventional treatment and taken i.v., once per 4 week, at a dose of 1*10E6 UC-MSC/kg body weight for 12 weeks.
16165112|NCT01662973|Other|Conventional plus placebo treatment|Received conventional treatment and taken i.v., once per 4 week, at 50 ml saline for 12 weeks
16165113|NCT01662960|Behavioral|Mirror therapy|A home-based therapy involving mirrored visual feedback
16165114|NCT01662960|Behavioral|Divider therapy|A home-based therapy involving removed visual feedback.
16165115|NCT01662947|Device|Blood pressure Transtek Wrist Blood Pressure Monitor, TMB-1117|Systolic, Diastolic pressure.
16165116|NCT01662947|Device|Blood pressure Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-2|Systolic, Diastolic pressure
16165117|NCT01662934|Device|I RUNE|
16165118|NCT01662934|Device|sham|
16165119|NCT01662921|Drug|NPH|Long acting insulin NPH dosing will be titrated weekly derived from the patients current weight and gestational age
16165120|NCT01662921|Drug|Insulin LISPRO|Insulin lispro dosing will be titrated weekly based on the patient's average SMBG readings from each meal during the past three days
16165121|NCT01662921|Drug|Insulin glulisine|Insulin glulisine will be titrated weekly based on the patient's average SMBG readings from each meal during the past three days
16165122|NCT01662908|Drug|edoxaban tosylate|edoxaban tosylate (DU-176b), film-coated for oral use, 90 mg once daily (QD) for 10 days (±2 days) followed by 60 mg QD for a total of approximately 90 days of edoxaban treatment
16165123|NCT01662908|Drug|enoxaparin/unfractionated heparin|enoxaparin - administered by subcutaneous injection;1 mg/kg/ twice daily or 1.5 mg/kg once daily unfractionated heparin - started with 5000 IU bolus intravenous administration, 1300 IU/h continuous infusion, minimum of 5 days of treatment and stopped when target INR (2.0 - 3.0) is achieved.
16165125|NCT01662895|Drug|Deferoxamine|Deferoxamine mesylate(62 mg/kg/day up to a maximum daily dose of 6000 mg/day) given by a continuous IV infusion for 5 consecutive days beginning within 24 hours of ICH symptom onset.
16165126|NCT01662895|Drug|Normal saline|This is a placebo. Normal saline will be given by a continuous IV infusion for 5 consecutive days beginning within 24 hours of ICH symptom onset.
16165127|NCT01662882|Drug|florbetapir (18F)|IV injection, 370 MBq(10mCi), single dose
16165128|NCT01662869|Drug|5-Fluoruracil|Participants will receive 5-fluorouracil 400 milligrams per square meter (mg/m^2) IV bolus and then 2400 mg/m^2 as a continuous IV infusion over 46-48 hours on Day 1 of every cycle until disease progression or at the maximum of 12 cycles, whichever occurs first.
16165129|NCT01662869|Drug|Folinic acid|Participants will receive folinic acid 400 mg/m^2 IV infusion over 2 hours on Day 1 of every cycle until disease progression or at the maximum of 12 cycles, whichever occurs first.
16165130|NCT01662869|Drug|Onartuzumab|Participants will receive onartuzumab 10 mg/kg IV infusion on Day 1 of every cycle (each cycle = 14 days) until disease progression, unacceptable toxicity, or participant or physician decision to discontinue treatment.
16165131|NCT01662869|Drug|Oxaliplatin|Participants will receive oxaliplatin 85 mg/m^2 IV infusion over 2 hours on Day 1 of every cycle until disease progression or at the maximum of 12 cycles, whichever occurs first.
16165132|NCT01662869|Drug|Placebo|Participants will receive onartuzumab matching placebo on Day 1 of every cycle (each cycle = 14 days) until disease progression, unacceptable toxicity, or participant or physician decision to discontinue treatment.
16165133|NCT01662856|Biological|Fibrin Sealant Grifols|Combination of 3 mL fibrinogen and 3 mL thrombin in separate syringes assembled on a syringe holder (6 mL of solution in total).
16165134|NCT01662856|Procedure|Manual Compression|Direct manual compression of target bleeding site with gauze/laparotomy pads.
16165135|NCT01662817|Behavioral|Intervention|PCP receives one day training in depression screening guidelines and uses guidelines for six months
16165136|NCT01662817|Behavioral|Control|PCP manages depression in the usual way for six months
16165137|NCT01662804|Drug|3F8 Monoclonal Antibody Combined with Interleukin-2|One cycle has 2 days of intravenous hu3F8 treatment, given about 7 days apart. rIL-2 is administered sc daily over 5 days, beginning on the second infusion of hu3F8. To limit side-effects, patients receive analgesics and antihistamines as premedications. Cycles are 21 days. Patients can have up to 4 cycles of treatment on this study within 18 months of starting hu3F8.
16165138|NCT01662791|Drug|Rifaximin|All individuals in the weight loss group (i.e., only the Case group) were offered open-label treatment with the poorly absorbed antibiotic, rifaximin, 550 mg PO BID for 14 days. Treatment will not depend upon the results of the bacterial overgrowth breath test. Thus, both normal and abnormal breath test subjects received antibiotic treatment.
16165139|NCT01662778|Drug|1.5 microns at 50mg|STAG generated monodisperse 1.5micron particles
16165140|NCT01662778|Drug|6 microns at 50mg|STAG generated monodisperse 6 micron particles
16165141|NCT01662778|Drug|Placebo Comparator|No drug just solvent
16165142|NCT01662778|Drug|MDI FP|
16165143|NCT01662765|Procedure|Surgery|modified umbilectomy
16165144|NCT01662765|Other|conservative|this treatment will include conservative procedures under local anesthesia for patient comfort.
16165145|NCT01662752|Drug|Indocyanine green|Please see arm description
16165146|NCT01662739|Behavioral|Questionnaire|
16165147|NCT01662726|Drug|Irosustat|Irosustat will be administered once daily in 40mg tablets. Treatment will start the day after the baseline FLT-PET and will be continued for a minimum of 2 weeks until the follow up FLT PET scan. For those patients who have consented to a repeat tumour biopsy, treatment will be extended to the day before the procedure. Study medication should be taken in the morning under fasting conditions with a glass of water, 30 minutes before breakfast.
16165148|NCT01662713|Device|OFDI|Imaging of skin
16165149|NCT01662700|Drug|Artesunate|
16165150|NCT01662700|Drug|Chloroquine|
16165151|NCT01662687|Drug|Sancuso patch|"Eligible patients were randomized to Sancuso patch or Kytril groups and received the assigned treatment for 4days.
~Experimental arm: Sancuso patch (34.3mg) applied to upper, outer arm 2days (48-24 hours) prior to start of chemotherapy."
16165152|NCT01662687|Drug|Kytril inj.+Kytril tab.|"Eligible patients were randomized to Sancuso patch or Kytril groups and received the assigned treatment for 4days.
~Active Comparator arm:
~Kytril inj. 3mg: administered by intravenous infusion at least 5 minutes, just before the first chemotherapy (Day 1).
~Kytril tab. 1mg: administered twice a day by orally at Day 2~4."
16165153|NCT01662674|Drug|gemigliptin and metformin HCl extended release|Coadministration of gemigliptin 50mg and metformin HCl extended release 1000mg, for 1 day
16165154|NCT01662674|Drug|gemigliptin/metformin HCl extended release|Administration of combination of gemigliptin 50mg/metformin HCl extended release 500mg, for 1day.
16165155|NCT01662661|Drug|JNJ-47910382 (suspension)|Type=exact number, unit=mg, number=200, form=suspension, route=oral. JNJ-47910382 administered on Day 1.
16165156|NCT01662661|Drug|JNJ-47910382 (tablet)|Type=exact number, unit=mg, number=200, form=tablet, route=oral. JNJ-47910382 administered on Day 1.
16165157|NCT01662648|Drug|Paliperidone ER|Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day will be given orally for 6 months as per Investigator's discretion.
16165158|NCT01662622|Drug|Sevoflurane|"The design of experiment is referred to the Dixon up-and-down method. The first subject was designed to receive end-tidal sevoflurane concentration of 1.7%. For each subject, 30 min interval time was given. The isoelectric EEG was considered as significant when the isoelectric state last for more than 1min. The maximal burst suppression rate was recorded if isoelectric EEG was not reached. Heart rate and MAP, were recorded 2 and 1min before and 3 min after skin incision. Adrenergic reflexes positive cases were counted."
16165159|NCT01662609|Procedure|Endoscopic Ultrasound (EUS)|Ultrasound scope will be passed through the participant's mouth into their stomach and their pancreas will be evaluated completely by the ultrasound scope. If an abnormality is found in their pancreas, a biopsy may be performed to obtain a diagnosis.
16165160|NCT01662583|Other|Text Message|
16165161|NCT01662583|Other|Written reminder|
16165203|NCT01662206|Dietary Supplement|Probiotic|2 capsules daily containing Lactobacillus gasseri, Bifidobacterium bifidum and Bifidobacterium longum (1.5 billion cells per capsule prior to expiration)
16266820|NCT00888446|Biological|tgAAC09|
16165162|NCT01662570|Behavioral|Beverage Choice and Lifestyle Modification|The family-based BCLM intervention trained children and parents in self monitoring of sugar sweetened beverage intake and goal-setting, incorporated feedback and reinforcement, and provided water bottles and water filters to promote a reduction in sugar sweetened beverages and overall energy intake. 16 sessions were provided over a 6-month period.
16165163|NCT01662570|Other|Nutrition Education (NE)|This treatment for parents and children addressed a variety of topics in nutrition including benefits of fruits and vegetables, the food pyramid, vitamins, benefits of eating a variety of foods, and healthy beverage selections. No behavioral change training component was included. 16 sessions over 24 weeks was provided.
16165164|NCT01662557|Behavioral|Family Behavior Modification|5-month intervention for parents and children providing 15 sessions in behavioral skills training in self monitoring, Traffic Light Diet, goal setting, reinforcement and tasting sessions. Of the 15 sessions, 3 were structured as phone sessions.
16165165|NCT01662557|Other|Minimal Nutrition Information|Families assigned to MNI received a series of 15 mailings on topics related identifying a healthy body weight for children; energy balance and calorie requirements for children; MyPyramid for Kids; portion control; the benefits of physical activity and screen-time reduction; encouraging fruit and vegetable consumption; healthy snacks and smart shopping; and encouraging family meals.
16165166|NCT01662544|Procedure|Oxygen delivery|
16165167|NCT01662531|Biological|rIX-FP|Recombinant Fusion Protein Linking Coagulation Factor IX with Albumin (rIX-FP)
16165168|NCT01662518|Device|Dexamethasone drug delivery system (DDS-25)|350 mg Dexamethasone posterior segment drug delivery system (DDS-25) injection into the vitreous cavity at baseline
16165169|NCT01662505|Drug|Volasertib|Patient to receive volasertib
16165170|NCT01662492|Biological|Botulinum toxin type A Dose 1|Botulinum toxin type A Dose 1 intramuscular injections into specified muscles.
16165171|NCT01662492|Biological|Botulinum toxin type A Dose 2|Botulinum toxin type A Dose 2 intramuscular injections into specified muscles.
16165172|NCT01662492|Drug|Placebo (Normal Saline)|Placebo (Normal Saline) intramuscular injections into specified muscles.
16165173|NCT01662466|Drug|Testosterone cream (0.5mg per gram)|Testosterone cream 2 gms per day applied transdermally to the left wrist to deliver 1.mg daily dose with estimated absorption of 100 ug per day testosterone
16165174|NCT01662466|Dietary Supplement|DHEA|DHEA 25mg tid
16165175|NCT01662466|Drug|Placebo|Carrier cream without added testosterone in the identical type of pump
16165176|NCT01662440|Biological|Rabies|Subjects received three doses of Rabies, whole virus vaccine (inactivated, Germany).
16165177|NCT01662440|Biological|Japanese Encephalitis|Subjects received two doses of Japanese Encephalitis vaccine.
16165178|NCT01662440|Other|Placebo|Subjects received either two, three, four or five doses of normal saline, 0.9% w/v sodium chloride depending on the vaccine group.
16165179|NCT01662427|Other|Questionaire to assess Noctural Parkinson's Disease Symptoms|Questionaire to assess Noctural Parkinson's Disease Symptoms and quality of life
16165180|NCT01662414|Dietary Supplement|Whey protein|1 sachect (10 g) 2times/ day
16165181|NCT01662414|Dietary Supplement|Soy protein|1 sachect (10g) 2times/day
16165182|NCT01662401|Drug|Bupivacaine|The volume of 0.25% Bupivacaine at 0.075 ml/kg without epinephrine is a maximum of 3 ml for rectus sheath blocks and 4 ml for ilioinguinal blocks adding up to a total maximum dose of 14 ml.
16165183|NCT01662401|Drug|Bupivacaine|The volume of 0.25% Bupivacaine at 0.075 ml/kg without epinephrine is a maximum of 14 ml.
16165184|NCT01662388|Device|Separation ring|Separation ring placed along with automatrix band
16165185|NCT01662388|Device|automatrix band|band placed with a tightening device
16165186|NCT01662375|Other|Surveillance and interview|The interventional nature of the study is justified by the need for particular monitoring of patients in whom life support is withdrawn following the clinical team's decision. The questions posed to the patient's family and/or relatives, do not modify the care provided to the patient.
16165187|NCT01662362|Device|Testing Donor Specimens with ESA Chagas|Donors will be asked to return for a follow-up blood draw.
16165188|NCT01662349|Device|MOE Antimicrobial Plasma Treatment System|Plasma applied to back for up to 20 minutes, twice/week for 4 weeks
16165189|NCT01662336|Drug|Lopinavir / ritonavir|Prescribed according to the product monograph and physician's discretion.
16165190|NCT01662336|Behavioral|Kaletra Adherence Support Assistance Program|A customized support network for patients treated with lopinavir / ritonavir that offers individual counseling with an HIV experienced nurse who assists patients with various aspects of their therapy including life-style changes, emotional stress, and adverse events, and may provide access to various healthcare professionals or may offer other types of support such as transportation, exercise, etc.
16165191|NCT01662323|Behavioral|GP's treating HF according the dutch guidelines|
16165192|NCT01662310|Drug|Paliperidone|Paliperidone extended-release (ER) oral tablet will be administered at a starting dose of 3 milligram (mg) up to 12 mg once daily for 8 weeks in Run-in or Stabilization phase, and 3-12 mg fixed dose oral tablet will be administered in DB phase. Participants who will enter open-label extension phase will receive paliperidone as 3-12 mg per day.
16165193|NCT01662310|Drug|Placebo|Participants who transitioned from run-in or stabilization phase will receive matching placebo to paliperidone ER once daily during DB phase of the study.
16165194|NCT01662297|Drug|Quetiapine|Quetiapine will be administered at a dosage prescribed by veterans' current providers for the treatment of insomnia.
16165195|NCT01662297|Drug|Trazodone|Veterans willing to switch from quetiapine to trazodone for the treatment of insomnia will receive up to 400mg of trazodone daily.
16165196|NCT01662284|Drug|124I-NM404|124I-NM404 administered at either 5mCi or 3mCi on day 1. If PET/CT images are diagnostically inadequate and there are no dose-limiting toxicities at current dose, next patients will receive the next higher level of 7.5 or 10 mCi.
16165197|NCT01662258|Device|Point-of-Care diagnostic laboratory test|All POC tests are FDA-cleared.
16165198|NCT01662232|Dietary Supplement|Green tea beverage|
16165199|NCT01662232|Dietary Supplement|Green tea extract|
16165200|NCT01662232|Dietary Supplement|EGCG|
16165201|NCT01662232|Other|Placebo|
16165202|NCT01662219|Other|Superficial cervical plexus block for experimental group|15 ml of 0.25% Bupivacaine will be given for superficial cervical plexus block
16165515|NCT01659606|Drug|Mycophenolate mofetil|
16165204|NCT01662206|Dietary Supplement|Placebo|2 capsules daily containing 348.25 mg of potato starch
16165205|NCT01662193|Dietary Supplement|vitamin D3 supplement|
16165206|NCT01662193|Dietary Supplement|calcium supplement|
16165207|NCT01662193|Dietary Supplement|vitamin D3 and calcium supplement|
16165208|NCT01662193|Dietary Supplement|placebo|
16165209|NCT01662180|Drug|Follicle Stimulating Hormone|All patients will receive a fixed 75 IU rec follicle stimulating hormone per day subcutaneous injection stimulation protocol starting from cycle day 3, 4 or 5. The intervention done in this study is conform normal stimulation protocol and is not the target of this study.
16165210|NCT01662167|Drug|Single|In the single dose regimen, 50 mg/m2 intramuscular methotrexate was given on day one and hCG level was measured on days four and seven. If the hCG level did not decrease by 15% between day four and seven, a second dose of methotrexate was injected on day seven, hCG level was measured weekly until a level of 15 mlU/ml or less was achieved
16165211|NCT01662167|Drug|Multipe|In the multiple dose regimen, 1 mg/kg/day intramuscular methotrexate was given on days one, three, five and seven and 0.1 mg/kg/day intramuscular Citrovoram factor was administered on days two, four, six and eight until serum hCG level decreased 15% in 48 hours or four doses of methotrexate was given weekly until serum hCG level of 15 mlU/ml or less was obtained
16165212|NCT01662154|Device|Neurometer assessment|Activity of nerve(s) to be blocked will be assessed with the Neurometer before and after administration of local anesthetic.
16165213|NCT01662154|Device|Nerve stimulator assessment|Activity of nerve(s) to be blocked will be assessed with the Stimuplex HNS 12 nerve stimulator before and after administration of local anesthetic.
16165214|NCT01662128|Drug|Xeloda|Xeloda as Adjuvant Therapy
16165215|NCT01662115|Drug|Nicotine gum|Patients will chew nicotine gum 3 times a day until discharge or 7 days, whichever comes first
16165216|NCT01662115|Other|Regular chewing gum|Patients will chew regular sugar-free gum 3 times a day until discharge or 7 days, whichever comes first
16165217|NCT01662102|Drug|Zevalin|Zevalin administered intravenously.
16165218|NCT01662102|Drug|Rituximab|Rituximab administered intravenously.
16165219|NCT01662089|Drug|15 mg Chelate zinc supplement|15 mg Chelate zinc additional to standard 5% minoxidil
16165220|NCT01662089|Drug|Placebo drug supplement|Placebo drug instead of Zinc supplement
16165221|NCT01662076|Other|Homeopathic Remedies|The homeopathic remedy will be administered as either 1 globule sublingual or 0.2 mL oral (depending on chosen formulation) up to 3 times per day. The homeopath will decide which formulation will be used. Homeopathic remedies prepared according to the standards as set out by Health Canada. The caregiver or patient will be asked to administer the homeopathic remedy at least 30 minutes before or after taking other medications, food and strong smelling substances (such as camphor, mint, or coffee).
16165222|NCT01662063|Drug|Tocilizumab|TCZ will be given as 162 mg SC QW or Q2W for up to 96 weeks.
16165223|NCT01662050|Drug|Rituximab, Bendamustine, Cytarabine.|6 cycles of 28 days with Rituximab, Bendamustine and Cytarabine (R-BAC). Rituximab 375mg/mq; Bendamustine 70mg/mq; Cytarabine 500mg/mq.
16165224|NCT01662037|Drug|Bosentan|Bosentan 2mg/kg/dose twice a day and routinely therapy in children with functional single ventricle during the period of staged Fontan procedure with high risk of increased PVR.
16165225|NCT01662024|Device|Endoscopic gastric restrictive procedure|Endoluminal gastric tissue approximation using an incisionless/per-oral endoscopic suturing device for primary gastric restrictive procedures
16165226|NCT01662011|Device|mode of neurally adjusted ventilatory assist|patients ventilated with the mode of neurally adjusted ventilatory assist after corrective open-heart surgery
16165227|NCT01662011|Device|Mode of pressure support ventilation|Patients ventilated with the mode of pressure support ventilation after corrective open-heart surgery
16165228|NCT01661985|Drug|Azithromycin|In the randomized arm giver orally 1 g as a single dose. In the non-randomized arm given for 5 days 250mg 2x1 first day and 1x1 following four days.
16165229|NCT01661985|Drug|Doxycycline|Doxycycline tablets 100 mg 2x1 the first day and 100 mg daily for following eight days (following the Swedish tradition and experience since the 1970s of treating chlamydia)
16165230|NCT01661985|Drug|lymecycline|Lymecycline 300 mg twice daily for 10 days (Summertime due to less risk of phototoxic reactions)
16165231|NCT01661972|Drug|Capecitabine and aflibercept|"Capecitabine given on days 1-14 and off days 15-21. Dose: Phase 1 cohort 1 850mg/m2 Phase 1 cohort 2 1000mg/m2, Phase 2 RPTD.
~Aflibercept will be held constant at 6 mg/kg, given intravenously every 3 weeks.
~Both agents will be administered on a 21-day cycle."
16165232|NCT01661946|Drug|Bevacizumab|Bevacizumab is an off-label but cheaper treatment for diabetic macular edema.
16165233|NCT01661946|Drug|Ranibizumab|Ranibizumab is a vascular endothelial growth factor inhibitor designed for ocular use
16165234|NCT01661933|Biological|Necator americanus|Previously inoculated subjects will be further inoculated as previously undertaken with 20 3rd stage infective Na larvae (10 + 10 over 4 weeks). Four weeks after the 2nd inoculation, each participant will receive a micro-dose of gluten (10 mg daily) as pasta for 8 weeks, to be followed by a low-dose of gluten (50 mg daily) for 8 weeks. After this, a detailed assessment involving upper endoscopy and duodenal biopsy will be performed before deciding on an individual case basis that it is safe for the participant to proceed to challenge. A gluten challenge of 1 G (15-20 G of pasta or a ½ slice of standard white bread) twice weekly for 12 weeks will commence.
16165235|NCT01661933|Biological|Necator americanus|After completion of the previously planned challenge, volunteers will be invited to extend the gluten challenge. The extension is for 4 weeks total. The gluten challenge is stepwise: gluten 10 mg daily for one week, 50 mg daily for one week and finally 3 grams daily for 2 weeks. The outcome measure is serum tissue transglutaminase to be compared before and after the intervention.
16165236|NCT01661920|Other|Intervention group|Shorten the duration of antibiotic treatment from 7-10 days to 5 days.
16165237|NCT01661920|Other|Control group|Those antibiotic duration treatments which are not modified by their doctors.
16165238|NCT01661907|Procedure|Combined Epi-GA/PCEA|An epidural catheter will be placed before the induction of general anesthesia. General anesthesia will be induced and maintained as in the control group, with the addition of epidural anesthesia which will be maintained with the use of 0.375%-0.5% ropivacaine during surgery. Patient-controlled epidural analgesia will be provided after surgery.
16165286|NCT01661543|Dietary Supplement|Peas|90 grams of peas will be consumed 5 out of 7 days per week
16165239|NCT01661907|Procedure|GA/PCIA|General anesthesia will be induced with midazolam, propofol, sufentanil and rocuronium. Anesthesia will be maintained with either intravenous (propofol), inhalational (sevoflurane with or without nitrous oxide), or combined intravenous-inhalational anesthetics. Additional opioids (remifentanil, sufentanil, fentanyl, or morphine) and muscle relaxant (rocuronium, atracurium, or cisatracurium) will be administered when deemed necessary by the attending anesthesiologists. Patient-controlled intravenous analgesia will be provided after surgery.
16165240|NCT01661894|Device|BrainPalTM|Brain-computer Interface (BCI) is a direct communication pathway between a human brain and an external device. It is a technology that enables people to interact with computers through their thoughts. Electroencephalography (EEG) is the best studied non-invasive interface facilitating such communication. The BCI system will take EEG recordings from the prefrontal cortex to determine the participants' state of attention with high specificity. The training program developed using this patented technology may be useful for individuals who experience difficulty with memory and sustaining their attention.
16165241|NCT01661881|Drug|Rituximab|
16165242|NCT01661881|Drug|Bendamustine|
16165243|NCT01661881|Drug|Cytarabine|
16165244|NCT01661868|Drug|Olaparib|Tablet formulation will be used.
16165245|NCT01661855|Drug|Riluzole|50mg once daily (QD) for 12 weeks for participants 6-11 years old; 50mg twice daily (BID) for 12 weeks for participants 12-17 years old
16165246|NCT01661855|Drug|Placebo|Placebo comparator once daily (QD) for 12 weeks for participants 6-11 years old; Placebo comparator twice daily (BID) for 12 weeks for participants 12-17 years old
16165247|NCT01661842|Other|conventional plus UC-MSC treatment|Received conventional treatment and taken i.v., once per 4 week, at a dose of 1×106 UC-MSC/kg body weight for 12 weeks.
16165248|NCT01661842|Other|Conventional plus placebo treatment|Received conventional treatment and taken i.v., once per 4 week, at 50 ml saline for 12 weeks
16165249|NCT01661816|Behavioral|interview|psychological, emotional, family and social parameters
16165250|NCT01661790|Drug|Bevacizumab|Bevacizumab300mg&Cispltin30mg by intrapleural administration of each 2 week
16165251|NCT01661790|Drug|Cisplatin|Cisplatin 30mg,intrapleural administration,each 2 week
16165252|NCT01661777|Drug|Nasal steroid|
16165253|NCT01661777|Procedure|Myringotomy tube placement|
16165254|NCT01661777|Drug|Diuretic|
16165255|NCT01661777|Drug|Antihistamine|
16165256|NCT01661777|Behavioral|Low salt diet|
16165257|NCT01661764|Drug|Eicosapentanoic acid and docosahexanoic acid|1395 mg EPA plus 1125 mg DHA daily for 24 weeks
16165258|NCT01661764|Drug|Oleic Acid|Placebo
16165259|NCT01661751|Biological|ACYW135 Meningococcal Polysaccharide Vaccine|600 subjects were divided into three groups (200 subjects in each group), adult (16~30 years of age), early youth (7~15 years of age) and children (2~6 years of age) to receive Group ACYW135 Meningococcal Polysaccharide Vaccine, 0.5 ml, one dose regime
16165260|NCT01661751|Biological|A+C Meningococcal Polysaccharide Vaccine|300 subjects were divided into three groups (100 subjects in each group), adult (16~30 years of age), early youth (7~15 years of age) and children (2~6 years of age) to receive Group AC Meningococcal Polysaccharide Vaccine, 0.5 ml, one dose regime
16165261|NCT01661738|Biological|Group ACYW135 Meningococcal Polysaccharide Vaccine|360 subjects were divided into three groups (120 subjects in each group), children (2~6 years of age), early youth (7~15 years of age) and adult (16~30 years of age) to receive Group ACYW135 Meningococcal Polysaccharide Vaccine, 0.5 ml, one dose regime
16165262|NCT01661725|Biological|Group ACYW135 Meningococcal Polysaccharide Vaccine|60 subjects were divided into three groups (20 subjects each group), adult (16~30 years of age), early youth (7~15 years of age) and children (2~6 years of age) to receive Group ACYW135 Meningococcal Polysaccharide Vaccine, 0.5 ml, one dose regime
16165263|NCT01661712|Device|Transcutaneous electrical stimulation|Transcutaneous electrical stimulation (one night of electrical current titrated according to skin sensation)
16165264|NCT01661712|Device|Sham stimulation|Sham stimulation for one night (no electrical stimulation)
16165265|NCT01661686|Device|Partially covered SEMS|Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
16165266|NCT01661686|Device|Fully covered SEMS|Boston Scientific, Natick, United States diameter 18 mm, lengths of 10, 12 and 15 cm available
16165267|NCT01661673|Drug|EVP-0962|Arms: 1,2,3,4
16165268|NCT01661673|Drug|Placebo|Arm 5
16165269|NCT01661660|Other|observationnal|Observation during a physical exercise
16165270|NCT01661647|Device|3D knee kinematic assessment under local anesthesia|3D knee kinematic assessment under local anesthesia
16165271|NCT01661634|Drug|Ularitide|
16165272|NCT01661634|Drug|Placebo|
16165273|NCT01661621|Drug|Detrusitol 4 mg QD|Group 1
16165274|NCT01661621|Drug|Doxazosin 4 mg QD|Group 2
16165275|NCT01661608|Device|Using the EOS for gastric restriction|
16165276|NCT01661595|Drug|Sildenafil|50 mg/day for 4 weeks
16165277|NCT01661595|Drug|tadalafil|10 mg/day for 4 weeks.
16165278|NCT01661595|Drug|Placebo|Placebo 1 capsule per day for four weeks.
16165279|NCT01661582|Other|CT/PET Myocardial Perfusion Imaging using O-15 water|
16165280|NCT01661582|Other|Coronary blood flow measured by doppler echocardiography|
16165281|NCT01661569|Other|Headspace On-the-go app|Participants will be given access to a 45-day programme of mindfulness meditation, created and branded by Headspace. They will be encouraged to listen to one meditation podcast each day, or as frequently as possible over 8 weeks.
16165282|NCT01661556|Drug|Miconazole|Miconazole 2% cream will be applied twice a day for 9 weeks. The affected surface will be washed and dried before application with a thin layer of the emulsion as indicated on the affected areas of the face.
16165283|NCT01661556|Drug|Hydroquinone|Hydroquinone 4% cream (Topical use), will be applied twice a day for 9 weeks. The affected surface will be washed and dried before application with a thin layer of the emulsion on affected areas of the face.
16165284|NCT01661543|Dietary Supplement|Beans|90g of beans per day for 5 out of 7 days per week will be given to participants for 6 weeks to determine the cholesterol lowering effects of various pulses.
16165285|NCT01661543|Dietary Supplement|Control (rice)|90g of rice per day will be given to the control group to demonstrate the cholesterol lowering effects of the experimental group.
16165516|NCT01659593|Other|procog|3 to 5 people group program
16165287|NCT01661530|Dietary Supplement|Vitamin E enhanced soup|vitamin E enhancement is by virtue of the natural vitamin E content of the food ingredients
16165288|NCT01661530|Dietary Supplement|Non-enhanced soups|Similar looking and tasting soups with low vitamin E content by virtue of food ingredients
16165289|NCT01661517|Behavioral|Motivational interviewing and referral to treatment|
16165290|NCT01661504|Behavioral|Integrated Screening|The intervention arm will consist of the following components (described in detail below): a) integrated IPV/Sexual and Reproductive Health Screening, b) supportive care, c) safety planning and harm reduction counseling, d) supported referrals, e) booster counseling sessions
16165291|NCT01661478|Other|Training on motivational interviewing|
16165292|NCT01661452|Other|Referral to counseling services if desired|
16165293|NCT01661439|Drug|low molecular weight heparin (enoxeparine)|1mg/kg enoxeparine SC daily from 1st day of the menstrual cycle and continue daily throughout the pregnancy after documentation of pregnancy,and stopped in absence of fetal cardiac activity.
16165294|NCT01661426|Behavioral|Low-Carbohydrate Diet|Counseling/instruction on how to follow a healthy low-carbohydrate diet for 6 months. One evening class/week for 8 weeks (8 total classes). Then one class every other week for 8 weeks (4 total classes). Then one class every four weeks for 8 weeks (2 total classes): 14 evening classes, total.
16165295|NCT01661426|Behavioral|Low-Fat Diet|Counseling/instruction on how to follow a healthy low-fat diet for 6 months. One evening class/week for 8 weeks (8 total classes). Then one class every other week for 8 weeks (4 total classes). Then one class every four weeks for 8 weeks (2 total classes): 14 evening classes, total.
16165296|NCT01661400|Drug|Metronomic Cyclophosphamide|
16165297|NCT01661400|Drug|Thalidomide|
16165298|NCT01661361|Procedure|blood levels|
16165299|NCT01661335|Drug|Ondansetron, dexamethasone, aprepitant|Ondansetron 0.15 mg/kg (max 16 mg) IV or PO every 8 hours for at least 3 days, but no longer than 5 days; dexamethasone 0.2mg/kg (max 10 mg) IV or PO daily for at least 3 days, but no longer than 5 days; and aprepitant 3 mg/kg (max 125 mg) PO on day 1, and aprepitant 2 mg/kg (max 80 mg) PO on days 2 and 3 during the first investigational antiemetic cycle. During the next investigational antiemetic cycle, members of this arm will be crossed-over into the placebo arm, where the aprepitant will be replaced by placebo and the dexamethasone dose will be increased to 0.4 mg/kg (max 20 mg) daily.
16165300|NCT01661335|Drug|Ondansetron, Dexamethasone, placebo|Ondansetron 0.15 mg/kg (max 16 mg) IV or PO every 8 hours for at least 3 days, but no more than 5 days; dexamethasone 0.4 mg/kg (max 20 mg) IV or PO daily for at least 3 days, but no more than 5 days; and a PO placebo for 3 days during the first investigational antiemetic cycle. During the second cycle, members this group will be crossed-over to the experimental arm, where the placebo will be replaced by aprepitant and the dexamethasone will be decreased by 50%.
16165301|NCT01661322|Drug|Aspirin, Dipyradimole, Clopidogrel|Participants in the intensive antiplatelet group will receive Asp+Dip+Clop triple therapy for 28-30 days (to cover the period of maximum risk of recurrence) along with standard 'best care' (including lifestyle advice, BP and lipid lowering). Clop will be given as a loading dose of 300 mg,12 then 75 mg daily, Asp as a loading dose of 300 mg,22 then 75 mg daily, and Dip modified release 200 mg twice daily 9 for 28-30 days.
16165302|NCT01661309|Dietary Supplement|Inactive lozenge|Manufactured to mimic 1mg methylcobalamin lozenge
16165303|NCT01661309|Dietary Supplement|Methylcobalamin|Aimed at reducing plasma tHcy.
16165304|NCT01661296|Other|RFH therapy|RFH therapy was administered by a single, controlled and localized delivery of radio frequencies into the lesion for 30-60 seconds under local anesthesia using a current field radio-frequency generator.
16165305|NCT01661296|Drug|Sodium stibogluconate|Six intralesional injections (one injection per week) of SSG 50mg/cm-2 area of lesions
16165306|NCT01661283|Drug|everolimus|10 mg tablet once daily
16165307|NCT01661283|Drug|bevacizumab|10 mg/kg dose every 14 days
16165308|NCT01661270|Drug|Aflibercept|Pharmaceutical form: Concentrate for Solution for infusion; Route of administration: Intravenous
16165309|NCT01661270|Drug|Placebo|Pharmaceutical form: Concentrate for Solution for infusion; Route of administration: Intravenous
16165310|NCT01661257|Drug|Infliximab|
16165311|NCT01661244|Drug|RV568 single dose|Safety and tolerability of single escalating doses in normal human volunteers
16165312|NCT01661244|Drug|RV568 matching placebo single dose|Safety and tolerability of escalating repeat doses in normal human volunteers.
16165313|NCT01661244|Drug|RV568 repeat dose|Safety and tolerability of escalating repeat doses in normal human volunteers.
16165314|NCT01661244|Drug|RV568 matching placebo repeat dose|Safety and tolerability of escalating repeat doses in normal human volunteers.
16165315|NCT01661231|Device|Astron/Pulsar-18 stent|Peripheral Vascular Intervention
16165316|NCT01661205|Device|Ablation procedure staged catheter ablation|AtriCure Bipolar System used in conjunction with a catheter ablation procedure performed 1-10 days apart
16165317|NCT01661192|Drug|AAT( Alpha 1 Antitrypsin)|
16165318|NCT01661179|Drug|Vandetanib 300mg|300 mg oral dose once daily (100 mg x 3 tablets)
16165319|NCT01661166|Drug|Fesoterodine|4 mg
16165320|NCT01661166|Drug|Placebo oral tablet|Placebo
16165321|NCT01661140|Drug|Methotrexate (stable dose)|Methotrexate (MTX) was administered weekly according to the subject's pre-study MTX dose
16165322|NCT01661140|Drug|Tocilizumab|8 mg/kg intravenously every 4 weeks for 72 weeks
16165323|NCT01661140|Drug|Methotrexate (tapering dose)|Tapering doses of methotrexate (MTX) were administered weekly from Week 24 to Week 56. Tapering doses depended on dose administered to the subject during the open label period. First tapering occurred at randomization (Week 24), second tapering at Week 32, third tapering at Week 40 and final tapering at Week 48.
16165324|NCT01661114|Drug|Gemcitabine|
16165325|NCT01661114|Drug|5-FU|
16165326|NCT01661114|Drug|Cisplatin|
16165327|NCT01661101|Drug|Dabigatran|Dabigatran 110 mg taken twice daily
16165328|NCT01661101|Drug|Placebo (for Dabigatran)|Dabigatran placebo taken twice daily
16165329|NCT01661101|Drug|Omeprazole|Omeprazole 20 mg capsule taken once daily
16165330|NCT01661101|Drug|Placebo (for Omeprazole)|Omeprazole placebo taken once daily
16165517|NCT01659593|Other|Placebo|
16165518|NCT01659580|Drug|T89 high dose|225mg bid
16165519|NCT01659580|Drug|T89 Low dose|150mg bid
16165520|NCT01659580|Drug|Sanqi+Bingpian|225 mg bid
16165331|NCT01661088|Drug|FOLFIRINOX|"Starting dose levels as following:
~Oxaliplatin 85mg/m2 intravenously over 120 minutes on day 1. Irinotecan 180mg/m2 intravenously over 90 minutes on day 1. NOTE: patients homozygous for the UGT1A1 (TA)7 promoter allele will be treated at an initial lower dose 140mg/m2 (please see Section 6.3.a) Leucovorin 400mg/m2 intravenously over 90 minutes on day 1. 5FU 400mg/m2 as bolus intravenous injection following leucovorin on day 1. 5FU 2,400mg/m2 infused intravenously as a continuous infusion over 46 hours following the bolus 5FU, beginning on day 1."
16165332|NCT01661088|Radiation|Intensity-modulated radiotherapy (IMRT)|50.0Gy in 2.0Gy per fraction
16165333|NCT01661088|Procedure|Surgical Exploration|Patients without metastatic disease will be offered surgical exploration.
16165334|NCT01661062|Other|Cone Beam Computed Tomography (CT) Scan|Cone beam CT scan is considered a noninvasive procedure (meaning that the procedure does not require breaking the skin or any tools that physically enter the body). It will add a small amount of additional radiation dose (less than 1%) to the head and neck. The increase in the amount of radiation is only a very small amount more than what patients who get standard daily imaging receive. The amount of radiation from the cone beam CT scans is not significant (less than 1%) when compared to the amount of radiation generally received for treatment of head and neck cancer.
16165335|NCT01660997|Drug|MLN9708|
16165336|NCT01660997|Drug|Dexamethasone|
16165337|NCT01660971|Drug|Dasatinib|Given PO
16165338|NCT01660971|Drug|Erlotinib Hydrochloride|Given PO
16165339|NCT01660971|Drug|Gemcitabine Hydrochloride|Given IV
16165340|NCT01660958|Dietary Supplement|MNP|The formulation of the multiple micronutrient powder (MNP) was based on low micronutrient intake, low bioavailability of iron and zinc in the Indian diet, and current World Health Organization (WHO)and Indian recommendations regarding fortification and age-specific nutrient requirements. The MNP formulations were produced by a certified company in India and include: Iron, Vitamin A, Vitamin C, Folic Acid, Zinc, Vitamin B12 Vitamin B2, plus filler (maltodextrin). Placebo included riboflavin and maltodextrin.
16165341|NCT01660958|Behavioral|Early Learning|• Infant will benefit from interventions that are based on responsive parenting, whereby caregivers respond to children's cues, provide opportunities for exploration, and engage in nurturant and reciprocal communication.
16165342|NCT01660945|Drug|placebo|
16165343|NCT01660945|Drug|vytorin|
16165344|NCT01660932|Drug|placebo|
16165345|NCT01660932|Drug|omega|
16165346|NCT01660919|Drug|placebo|
16165347|NCT01660919|Drug|rosuvastatin|
16165348|NCT01660906|Drug|Dasatinib|tablets, oral, 100 mg, Once daily, Up to12 months on study,
16165349|NCT01660893|Drug|Tetracaine HCl 3% and oxymetazoline HCl 0.05%|3 unilateral intranasal sprays per dose
16165350|NCT01660893|Drug|Tetracaine HCl 3%|3 unilateral intranasal sprays per dose
16165351|NCT01660893|Drug|Placebo|3 unilateral intranasal sprays per dose
16165352|NCT01660867|Drug|3% saline + oral placebo|nebulized epinephrine + 3% saline + placebo => nebulized epinephrine + 3% saline
16165353|NCT01660867|Drug|0.9% saline + oral dexamethasone|nebulized epinephrine + 0.9% saline + dexamethasone => nebulized epinephrine + 0.9% saline
16165354|NCT01660854|Biological|Heterologous challenge|challenge by the bites of 5 Plasmodium falciparum infected mosquitoes.
16165355|NCT01660854|Drug|Malarone treatment|Three days: 4 tablets 250/100mg per day
16165356|NCT01660841|Drug|Gadobutrol (Gadovist, BAY86-4875)|A single bolus injection of gadobutrol 1.0M 0.1mmol/kg body weight.
16165357|NCT01660828|Other|remote ischemic preconditioning (RIPC)|RIPC protocol which consist of three 5-min cycles of bilateral forearm ischemia
16165358|NCT01660815|Drug|florbetapir (18F)|IV injection, 370 MBq (10mCi), single dose
16165359|NCT01660802|Drug|700 μg Dexamethasone|700 μg Dexamethasone intravitreal injection in the study eye on Day 1.
16165360|NCT01660802|Other|Sham|Sham administered in the study eye on Day 1.
16165361|NCT01660789|Behavioral|Physical activity, dietary counseling, coaching|Physical activity, dietary counseling, coaching
16165362|NCT01660763|Drug|Sufentanil NanoTab PCA System/15 mcg|15 mcg Sufentanil NanoTab dosed sublingually every 20 minutes as needed for pain for at least 48 hours. Patients may elect to remain in study for up to 72 hours.
16165363|NCT01660763|Drug|Placebo Sufentanil NanoTab PCA System|Placebo NanoTab dosed sublingually every 20 minutes as needed for pain for at least 48 hours. Patients may elect to remain in study for up to 72 hours.
16165364|NCT01660750|Drug|Carfilzomib|IV over 30 minutes on Days 1,2,8,9,15, and 16 every 28 days
16165365|NCT01660750|Drug|Cyclophosphamide|PO on days 1, 8, and 15 every 28 days
16165366|NCT01660750|Drug|Dexamethasone|40 mg weekly PO or IV on Days 1, 8, 15, and 22, every 28 days.
16165367|NCT01660724|Procedure|Ultrasound guided arterial puncture|Arterial puncture is performed using simultaneously ultrasound in order to guide the passage of the syringe from the patient's skin to the artery
16165368|NCT01660724|Procedure|Conventional arterial puncture technique|Arterial puncture is performed using the conventional technique
16165369|NCT01660711|Drug|5 Fluorouracil|2400 mg/m2 by continuous intravenous infusion over 46 hours
16165370|NCT01660711|Drug|Leucovorin|400 mg/m2 by IV infusion over 2 hours
16165371|NCT01660711|Drug|Irinotecan|180 mg/m² IV infusion on Day 1 over 90-120 minutes (infusion via a Y connector during the infusion of leucovorin)
16165372|NCT01660711|Drug|Oxaliplatin|85 mg/m² IV infusion on Day 1 over 2 hours
16165373|NCT01660698|Dietary Supplement|Maltodextrin|maltodextrin powder
16165374|NCT01660698|Dietary Supplement|Probiotic|probiotic blended in maltodextrin powder
16165375|NCT01660685|Behavioral|Tracking|Participants will record their daily weight, physical activity steps and meal replacements online
16165376|NCT01660685|Behavioral|Journaling|Participants will journal to two online writing prompts: one on positive focus and one on goal setting
16165377|NCT01660685|Behavioral|Website|Participants will have access to resource website with stories and tips from people who successfully lost weight, blogs from investigators, quotes from other participants.
16165378|NCT01660685|Behavioral|Enhanced Usual Care|Participants will receive standard care of monthly height, weight and blood pressure measurements. Participants will also receive a pedometer and a diet plan book on pre-portioned items.
16165521|NCT01659580|Drug|Placebo|225mg bid
16165841|NCT01657071|Drug|clopidogrel & aspirin|clopidogrel tablet(75mg) + aspirin capsules(100mg) by oral
16165379|NCT01660672|Drug|LEVETIRACETAM|liquid, 40 mg/kg loading dose and 30mg/kg every 12 hours via nasogastric tube for 3 days--this is standard dose. If primary outcome is not reached, dose escalation to 150, 225, and 300% standard, as needed, will be conducted.
16165380|NCT01660659|Device|Biomass Briquettes and Rocket stove|Biomass briquettes are made from dried peanut shells. Rocket stoves were designed to efficiently burn the briquettes
16165381|NCT01660646|Behavioral|Behavioral: community sensitization|Behavioral, enhanced case finding (ECF) by community sensitization via audiovisual presentation in local languages, a session for questions and answers and opportunity to provide sputum specimens for detection of TB
16165382|NCT01660633|Drug|High-Dose Melphalan HCL for Injection (Propylene Glycol-Free)|200 mg melphalan/m2 will be divided into two separate, consecutive doses of 100 mg/m2 administered on day -3 and day -2 prior to ASCT. The High-Dose Melphaln HCL for Injection (Propylene Glycol-Free) will be reconstituted to 5 mg/mL (also containing 270 mg/mL of Captisol®). The Melphalan HCL for Injection (Propylene Glycol Free) will be further diluted with normal saline to a concentration of no greater than 0.45 mg/mL and infused over 30 minutes ( + or - 3 minutes)via a central venous catheter.
16165383|NCT01660633|Other|Autologous Transplantation|Patients who are myeloablative conditioning in multiple myeloma undergoing autologous transplantation( patients own blood-forming stem cells are collected to replace diseased bone marrow or bone marrow damaged by cancer treatment)
16165384|NCT01660620|Drug|Betaxolol|
16165385|NCT01660620|Drug|topical betaxolol|given topically
16165386|NCT01660607|Biological|Conventional T cells (Tcon) and Regulatory T cells (Treg)|A baseline cell dose of conventional T cells of 1x10^6/kg will be used with escalation to the maximum tolerated dose up to 1x10^7/kg
16165387|NCT01660594|Other|CT calcium scoring|CT Calcium scoring was performed in the patients as an imaging test in addition to the traditional assessment on the same day of patients attending the chest pain clinic on the first visit. This was performed with standard protocol and the absolute calcium score was calculated.
16165388|NCT01660581|Biological|intramyocardial injection (electromechanical mapping based)|Patient will undergo 3D electric and mechanical intracardiac mapping; based on maps generated intramyocardial administration of autologous CD133+ cells or placebo will be performed.
16165389|NCT01660581|Biological|Placebo|Patients in the placebo group receive 0.9% NaCl solution with 0.5% solution of the patient's own serum.
16165390|NCT01660542|Drug|Neoadjuvant Chemotherapy with Docetaxel|Doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 (day 1), IV (in the vein), every 21 days, a total of 4 cycles -> Docetaxel 100 mg/m2 (day 1) IV, every 21 days, a total of 4 cycles
16165391|NCT01660529|Biological|hTERT|
16165392|NCT01660503|Dietary Supplement|0 grams SCF|Given in snack foods (muffins and flavored beverage)
16165393|NCT01660503|Dietary Supplement|10 grams SCF|Given in snack foods (muffins and flavored beverage)
16165394|NCT01660503|Dietary Supplement|20 grams SCF|Given in snack foods (muffins and flavored beverage)
16165395|NCT01660490|Procedure|ORIF|Open reduction internal fixation of the proximal femur
16165396|NCT01660477|Drug|Isavuconazole|oral
16165397|NCT01660477|Drug|Lopinavir/ritonavir|oral
16165398|NCT01660464|Behavioral|CBT Based Self-help Workbook + Counseling Telepho|Over a period of 12 months parents work through 8 self-help booklets and additionally receive 14 counseling telephone calls. The intervention has a cognitive-behavioral foundation. Primary purpose of counseling telephone calls is to clarify contents of the booklets and support parents in managing their homework assignments accompanied with each booklet.
16165400|NCT01660425|Behavioral|Enhancement with psychosocial intervention|
16165401|NCT01660412|Drug|Standard of Care First|For the second injection, and randomly after that, Sodium Bicarbonate will be compounded with Tc-99m SC, to raise the pH up to ~7.40.
16165402|NCT01660412|Drug|ph Altered first|For the first injection, Sodium Bicarbonate will be compounded with Tc-99m SC, to raise the pH up to ~7.40. For the second injection, the standard of care will be given, and randomly after that either standard of care, or pH altered will be given.
16165403|NCT01660399|Drug|Boanmycin|Boanmycin 5-6 mg/m2 + DXM 5mg IVD or IM, day 3,5,10,12, 21days a cycle.
16165404|NCT01660399|Drug|Docetaxel|Docetaxel 75mg/m2, intravenous infusion, day 1.
16165405|NCT01660386|Drug|Sitagliptin|100mg po once
16165406|NCT01660386|Drug|Saxagliptin|5mg po once
16165407|NCT01660386|Drug|Glimepiride|2mg po once
16165408|NCT01660386|Drug|Blank control|the subjects take no medication at experimental day and start bi-phase hyperglycaemic clamp at 9am.
16165409|NCT01660373|Drug|Tirofiban|0.4ug/kg/min for 30min followed by 0.1ug/kg/min
16165410|NCT01660373|Drug|Ticagrelor|loading dose(180mg) followed by maintenance dose(90mg bid)
16165411|NCT01660360|Biological|Tanibirumab|
16165412|NCT01660347|Biological|Allogeneic hematopoietic stem cell transplantation|Undergo allogeneic PBSCT boost using the CliniMACS CD34 Reagent System
16165413|NCT01660347|Biological|Peripheral blood stem cell transplantation|Undergo allogeneic PBSCT boost using the CliniMACS CD34 Reagent System
16165414|NCT01660347|Procedure|Management of therapy complications|Undergo allogeneic PBSCT boost using the CliniMACS CD34 Reagent System
16165452|NCT01660009|Other|Glycemic clamping|During hypoglycemic clamping, individuals will have a blood glucose level of 50-60 mg/dL for approximately 1 hour prior to outcome measurements. During euglycemic clamping, individuals will have a blood glucose level of 85-99 mg/dL for approximately 1 hour prior to outcome measurements.
16165453|NCT01659996|Biological|Meningococcal polysaccharide diphtheria toxoid conjugate|0.5 mL, Intramuscular
16165454|NCT01659996|Biological|Meningococcal polysaccharide diphtheria toxoid conjugate + Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed|0.5 mL, Intramuscular
16165455|NCT01659996|Biological|Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate|0.5 mL, Intramuscular
16165640|NCT01658657|Drug|Amlodipine|
16165415|NCT01660334|Drug|Voriconazole|"Voriconazole Intravenous Solution 200 mg:
~Voriconazole is administered by intravenous drip infusion at the dose of 6 mg/kg twice daily on day 1 and 3 mg/kg or 4 mg/kg twice daily from day 2 onward in adults.
~Voriconazole Tablet 50 mg/ Voriconazole Tablet 200 mg:
~administration for an adult (weighing 40 kg or more) is voriconazole 300mg orally twice daily between meals for day 1 and then 150 mg or 200 mg twice daily between meals from day 2 onward.
~Depending on the symptoms or in cases where the effect is insufficient, the dosage may be increased.
~However, the maximum dose on day 1 must be 400 mg twice daily, and the maximum dose from day 2 onward must be 300 mg twice daily.
~In patients weighing less than 40 kg, voriconazole 150 mg shall be administered twice daily on day 1, and voriconazole 100 mg shall be administered twice daily from day 2 onward.
~Depending on the symptoms, the maintenance dose from day 2 onward may be increased to 150 mg twice daily."
16165416|NCT01660321|Drug|spinosad|A sufficient amount of Natroba Topical Suspension was applied to completely cover the scalp, worked out to the ends of the hair, and left in place for 10 minutes (±30 seconds), followed by a complete rinse and shampoo.
16165417|NCT01660295|Drug|Certoparin 3,000 IU Once Daily|Certoparin 3,000 IU subcutaneous injection once daily
16165418|NCT01660295|Drug|Certoparin 3,000 IU Twice a Day|Certoparin 3,000 IU subcutaneous injection twice a day
16165419|NCT01660295|Drug|Certoparin 8,000 IU Once Daily|Certoparin 8,000 IU subcutaneous injection once daily
16165420|NCT01660295|Drug|Certoparin 8,000 IU Twice a Day|Certoparin 8,000 IU subcutaneous injection twice a day
16165421|NCT01660256|Drug|OPC-12759|Instillation, 4 times/day for 4 weeks
16165422|NCT01660256|Drug|Placebo|
16165423|NCT01660243|Drug|Nalfurafine hydrochloride(MT-9938) 2.5μg|2.5 μg (2capsules) once daily for 8 weeks
16165424|NCT01660243|Drug|Nalfurafine hydrochloride(MT-9938) 5μg|5 μg (2capsules) once daily for 8 weeks
16165425|NCT01660243|Drug|Nalfurafine hydrochloride(MT-9938) 10μg|10 μg (2capsules) once daily for 8 weeks
16165426|NCT01660243|Drug|Placebo|Placebo (2capsules) once daily for 8 weeks
16165427|NCT01660230|Biological|3K3A-APC, diluted in 0.9% sodium chloride in water|
16165428|NCT01660230|Drug|0.9% NaCl in water|
16165429|NCT01660217|Other|A written Eczema Action Plan (EAP)|A written Eczema Action Plan (EAP) was given to the patients with their treatment regimen.
16165430|NCT01660204|Other|Preferred empirical treatment|The investigators are using a cluster-randomized cross-over design for preferred empirical treatment. One of the 3 treatment arms is used as preferred empirical therapy during a period of 4 consecutive months, after which preferred treatment will rotate to 1 of the other 2 regimens. The order of change is randomised per hospital, thereby controlling for inter-hospital variables and minimizing seasonal influences.
16165431|NCT01660191|Drug|Pitavastin 4mg|
16165432|NCT01660191|Drug|Atorvastatin 20mg|
16165433|NCT01660191|Drug|Rosuvastatin 5mg|
16165434|NCT01660152|Other|Sexual Health Inventory for Men (SHIM) questionnaire administration|Questionnaire will be completed prior to surgery and at 3, 6, 12 months and the compliance questionnaire at 3, 6, 12 months.
16165435|NCT01660152|Procedure|management of therapy complications|Receive VED
16165436|NCT01660152|Procedure|Daily vacuum therapy|Patients randomized to Group A or Group B following removal of catheter at first post op visit following surger. Daily vacuum therapy for approximately 10 minutes. Depending on which group randomized to erection held for 2 minutes or 5 mintues.
16165437|NCT01660126|Drug|Levothyroxine|The intervention will start with Levothyroxine 50 µg daily (reduced to 25 µg in subjects <50Kg body weight or if known coronary heart disease - previous myocardial infarction or symptoms of angina pectoris) versus matching placebo; at 3 months if the serum TSH level is <0.4 mU/L dose will be reduced by 25 µg; TSH >=0.4 and <4.6 mU/L, no change to dose; TSH >=4.6mUL, additional 25 µg. The process will be repeated at 12 months then annually. Mock titration will be performed in the placebo group. The maximum possible dose of Levothyroxine that will be prescribed is 150μg.
16165438|NCT01660126|Drug|Placebo|
16165439|NCT01660100|Procedure|Pulmonary vein antrum isolation (PVAI)|In this group, only standard PVAI will be performed during the primary procedure. Three months later, a 2nd procedure will be performed in all subjects regardless of the recurrence of atrial arrhythmias. Subjects in whom pulmonary vein antrum remains isolated will enter follow-up; however, patients who have pulmonary vein-left atrium reconnection will undergo an re-isolation. Patients who have pulmonary vein antrum re-isolation are subject to a 3rd procedure 3 months later to check the status of pulmonary vein-left atrium connection. Patients will enter follow-up for long-term outcome only after permanent PVAI is confirmed by a repeat procedure.
16165440|NCT01660100|Procedure|PVAI plus left atrial posterior wall (LAPW) isolation|In this group, PVAI will be extended to the entire LAPW to achieve LAPW isolation during the primary ablation. Three months later, a 2nd procedure will be performed in all subjects regardless of the recurrence of atrial arrhythmias. Subjects in whom pulmonary vein antrum and LAPW remain isolated will enter follow-up; however, patients who have pulmonary vein antrum and/or LAPW reconnection will undergo a re-isolation. Patients who have pulmonary vein antrum and/or LAPW re-isolation are subject to a 3rd procedure three month later to check the presence of pulmonary vein antrum and/or LAPW re-connection. Patients will enter follow-up for long-term outcome only after PVAI and LAPW isolation are proven by a repeat procedure.
16165441|NCT01660087|Device|Biophotonic platform for VOC detection|Multiplex detection of VOCs with high sensitivity and specificity using a novel biophotonic device.
16165442|NCT01660074|Other|test food|All food, include reference food was tested in 50g available carbohydrate portion size.
16165443|NCT01660048|Procedure|SILS TEP repair|perform the laparoscopic total extraperitoneal inguinal hernia repair using a single port
16165444|NCT01660048|Procedure|Total extraperitoneal inguinal hernia repair|Conventional multiport laparoscopic total extraperitoneal inguinal hernia repair
16165445|NCT01660022|Drug|100mg OZ439 single oral dose|100mg OZ439 oral suspension single dose
16165446|NCT01660022|Drug|Placebo|Placebo
16165447|NCT01660022|Drug|300 mg OZ439 single oral dose|300mg OZ439 oral suspension single dose
16165448|NCT01660022|Drug|160mg Piperaquine single oral dose|160 mg Piperaquine tablet
16165449|NCT01660022|Drug|480mg Piperaquine single oral dose|480 mg Piperaquine tablet
16165450|NCT01660022|Drug|1440mg Piperaquine single oral dose|1440 mg Piperaquine tablet
16165451|NCT01660022|Drug|800 mg OZ439 single oral dose|800mg OZ439 oral suspension single dose
16165514|NCT01659606|Drug|Cyclosporins|
16165456|NCT01659983|Procedure|Primary wound closure|A wound will be sutured immediately after the operative procedure uisng non-absorbable monofilament suture or stapler at intervals of one centimeter apart and 0.5 cm back from a wound edge.
16165457|NCT01659957|Behavioral|Group Couples Counseling|
16165458|NCT01659957|Behavioral|One-on-One Couples Counseling|
16165459|NCT01659944|Drug|Eliglustat|Capsules for oral administration
16165460|NCT01659944|Drug|Metoprolol|Tablets for oral administration
16165461|NCT01659931|Drug|Montelukast|10 mg Tablet
16165462|NCT01659931|Drug|Singulair|10 mg Tablet
16165463|NCT01659918|Drug|Montelukast|
16165464|NCT01659918|Drug|Singulair|
16165465|NCT01659905|Drug|Montelukast|Chewable Tablet
16165466|NCT01659905|Drug|Singulair|5 mg Chewable Tablet
16165467|NCT01659892|Drug|Montelukast|5 mg Chewable Tablet
16165468|NCT01659892|Drug|Singulair|5 mg Chewable Tablet
16165469|NCT01659879|Behavioral|Multimedia information|
16165470|NCT01659879|Behavioral|verbal information|
16165471|NCT01659866|Drug|Ciprofloxacin|500 mg orally 2 hours before prostate biopsy
16165472|NCT01659866|Drug|trimethoprim-sulfamethoxazole|1 double strength tablet orally 2 hours before the procedure and again 12 hours later
16165473|NCT01659866|Drug|cefuroxime|500 mg orally 2 hours before the procedure then again 12 hours later
16165474|NCT01659866|Drug|ceftriaxone|500 mg intramuscularly 2 hours before the procedure
16165475|NCT01659866|Drug|gentamicin|2 mg/kg intramuscularly 2 hours before the procedure
16165476|NCT01659866|Drug|amikacin|5 mg/kg intramuscularly 2 hours before the procedure
16165477|NCT01659866|Drug|aztreonam|500 mg intramuscularly 2 hours before the procedure
16165478|NCT01659866|Drug|imipenem|500 mg intramuscularly 2 hours before the procedure
16165479|NCT01659866|Drug|ceftriaxone|2000 mg intravenously 1 hour before the procedure
16165480|NCT01659866|Drug|gentamicin|2 mg/kg intravenously 1 hour before the procedure
16165481|NCT01659866|Drug|amikacin|5 mg/kg intravenously 1 hour before the procedure
16165482|NCT01659866|Drug|aztreonam|2000 mg intravenously 1 hour before the procedure
16165483|NCT01659866|Drug|imipenem|1000 mg intravenously 1 hour before the procedure
16165484|NCT01659853|Drug|CD07805/47 gel 0.5%/CD07805/47 Vehicle|"To maintain masking, CD07805/47 gel 0.5% will be administered along with CD07805/47 gel vehicle.
~During each treatment period (baseline to Day 15):
~CD07805/47 gel 0.5%, topical, once daily and CD07805/47 gel vehicle, topical, once daily"
16165485|NCT01659853|Drug|azelaic acid gel 15%|During each treatment period (baseline to Day 15): azelaic acid gel 15%, topical, twice daily
16165486|NCT01659840|Radiation|Red laser|On the pain points of muscle, laser was applied (8J/cm ²) with an interval of 48 hours between applications. In the joints with sensitivity, a dose of 4J/cm2 laser was applied with an interval of 48 hours between applications.
16165487|NCT01659840|Radiation|Infrared laser|On the pain points of muscle, laser was applied (8J/cm ²) with an interval of 48 hours between applications. In the joints with sensitivity, a dose of 4J/cm2 laser was applied with an interval of 48 hours between applications.
16165488|NCT01659827|Other|Marcaine|Injection of 2cc of Marcaine
16165489|NCT01659827|Other|0.5cc AmnioFix|Injection of 0.5cc of AmnioFix Injectable
16165490|NCT01659827|Other|1.25cc AmnioFix|Injection of 1.25cc of AmnioFix Injectable
16165491|NCT01659827|Other|Saline|Injection of 1.25cc of Saline
16165492|NCT01659801|Device|BunnyLens TR|BunnyLens TR IOL is an Aspheric Toric intraocular lens providing a precise, superior alternative to surgical treatment of pre-existing corneal astigmatism.
16165493|NCT01659788|Dietary Supplement|Coenzyme Q10 concomitant treatment|
16165494|NCT01659788|Dietary Supplement|Placebo|
16165495|NCT01659775|Drug|Sancuso patch|"Eligible patients were randomized to Sancuso patch or Zofran groups and received the assigned treatment for 5days.
~Experimental arm: Sancuso patch (34.3mg) applied to upper, outer arm 2days (48-24hours) prior to start of chemotherapy."
16165496|NCT01659775|Drug|Zofran inj.+Zofran tab.|"Eligible patients were randomized to Sancuso patch or Zofran groups and received the assigned treatment for 5days.
~Active Comparator arm: administered intravenously (24mg or 32mg) on Day 1 of chemotherapy and orally (8mg bid) on Day 2-5."
16165497|NCT01659762|Biological|autologous mesenchymal stromal cell|
16165498|NCT01659749|Behavioral|Metabolic camp|To use an recreational camp setting to instruct PKU females of reproductive age how to make responsible dietary and reproductive decisions.
16165499|NCT01659736|Device|TMS|Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.
16165500|NCT01659723|Drug|Hyperbaric Oxygen|100% oxygen at 240-250 kPa will be delivered to the patents for 80-90 minutes while sitting or lying in a hyperbaric oxygen chamber. Patients will receive treatment once every day, except week-ends, for 40 days.
16165501|NCT01659697|Behavioral|intensive lifestyle counseling|Intensive lifestyle counseling will include a bi annual visit of the primary physician and nurse, a group intervention about use of medical resources, healthy lifestyle a one to one intervention with a dietician about diet and a one to one intervention with a physiotherapist about exercise
16165502|NCT01659684|Biological|standard intravenous immunoglobulin|Human standard intravenous immunoglobulin (IVIG), 0.5 g/Kg of body weight, monthly after confirmation of primary gestational CMV infection
16165503|NCT01659671|Procedure|Uvulopalatopharyngoplasty|Uvulopalatopharyngoplasty: Resection of the soft palate 3 mm and tonsillectomy, amputation of the uvula to approx 1 cm, single sutures of the posterior pillar to the anterior pillar and of the soft palate.
16165504|NCT01659658|Drug|IXAZOMIB|IXAZOMIB capsules
16165505|NCT01659658|Drug|Dexamethasone|Dexamethasone tablets
16165506|NCT01659658|Drug|Melphalan|Melphalan tablets
16165507|NCT01659658|Drug|Cyclophosphamide|Cyclophosphamide tablets
16165508|NCT01659658|Drug|Thalidomide|Thalidomide capsules
16165509|NCT01659658|Drug|Lenalidomide|Lenalidomide capsules
16165510|NCT01659645|Drug|FACBC|Drug FACBC will be given intravenously (IV) over 2 minutes prior to performing the PET scan
16165511|NCT01659619|Drug|Erythromycin|125mg in normal saline single use infusion for 5 min.
16165512|NCT01659606|Biological|alemtuzumab|Conditioning: alemtuzumab 0.2 mg/kg/dose IV x 5 doses
16165513|NCT01659606|Drug|Fludarabine|fludarabine 30 mg/m2/dose IV x 6 doses
16165522|NCT01659567|Drug|Pegylated Interferon Alfa-2a|Pegylated interferon alfa-2a will be administered according to the current standard of care and in line with current summaries of product characteristics/local labelling.
16165523|NCT01659567|Drug|Ribavirin|Ribavirin will be administered according to the current standard of care and in line with current summaries of product characteristics/local labelling.
16165524|NCT01659554|Drug|Cisplatin|Cisplatin (75 mg/m2) prepared in 2L normal saline.
16165525|NCT01659554|Drug|Doxorubicin|Doxorubicin (25 mg flat dose) prepared in 500 ml dialysis fluid (glucose or icodextrin-based).
16165526|NCT01659541|Device|Expiratory muscle stimulator|The expiratory muscle stimulator consists of two small electrodes (wire leads) implanted on the surface of the spinal cord on the lower back to stimulate the expiratory muscles and restore cough. These electrodes are connected to an implanted receiver in the abdomen or chest wall. The device is activated through an external antenna connected to an external control box.
16165527|NCT01659541|Procedure|Implantation of device|The expiratory muscle stimulator consists of two wire leads(each with two metal contacts) inserted onto the surface of their spinal cord on the lower back using a needle. The procedure to implant these wire leads is commonly used today for other purposes. This is a minimally invasive surgical technique with minimal risks. The wire leads are connected to an implanted receiver in the abdomen or chest wall. The device is activated through an external antenna connected to an external control box to stimulate the expiratory muscles and restore cough.
16165528|NCT01659515|Drug|Arbekacin Sulfate|Intravenous arbekacin in a total daily dose of 5-7 mg/kg
16165529|NCT01659502|Drug|TL-118|TL-118 investigational product is supplied as an oral liquid for daily administration at a specific dosing regimen. Treatment protocol includes weekly therapy cycles
16165530|NCT01659476|Other|Methacholine(MCh) Challenge Testing|"Visit 1: High-dose methacholine challenge test
~Visit 2 or 3: Will be conducted in random order and subjects will perform one of two modified single-dose methacholine challenge tests at either visit. During these modified challenges, subjects will (a) perform five DIs from functional residual capacity (FRC) to total lung capacity (TLC) back to FRC, or (b) refrain from taking DIs prior to inhaling the previously measured single PC20 dose of methacholine."
16165531|NCT01659476|Other|Methacholine(MCh) Challenge Testing|"Visit 1: Baseline tests, and subjects will be randomized to complete either a high-dose methacholine using maximal expiratory flow-volume loop (MEFV), or a high-dose methacholine challenge with impulse oscillometry (IOS) and partial expiratory flow-volume loop (PEFV) and MEFV at each dose step.
~Visit 2: Subjects will perform the opposite protocol, based on their first visit:"
16165532|NCT01659463|Other|ICON|LOW VISCOSITY RESIN WILL BE APPLIED IN EARLY PROXIMAL CARIES LESIONS
16165533|NCT01659463|Behavioral|instruction oral hygiene|Instructions diet and hygiene oral and topical fluoride
16165534|NCT01659450|Other|low energy dense|This group received a diet appropriate with their weight in the form of low energy density diet
16165535|NCT01659450|Other|control|This group received a diet appropriate with their weight in the form of an usual diet regarding the energy density.
16165536|NCT01659450|Other|diet|Calorie requirements of each subject were estimated based on resting energy expenditure (by the use of Harris-Benedict equation) and physical activity levels.
16165537|NCT01659437|Drug|Clarithromycin Extended Release|oral administration of Clarithromycin extended release
16165538|NCT01659437|Drug|Streptomycin intramuscular injection|daily intramuscular drug injection
16165539|NCT01659424|Radiation|High Dose Rate Endorectal Brachytherapy (HDR-ERBT)|Combining pre-operative FOLFOX chemotherapy with HDR-ERBT (Radiation therapy) followed by surgery then additional FOLFOX chemotherapy to decrease the risk of distant metastasis and to maintain excellent locoregional control with decreased morbidity.
16165540|NCT01659411|Other|Observational|Yearly clinical visits
16165541|NCT01659398|Device|External Counterpulsation (EECP)|A noninvasive neuroimaging technique. Administration of 35 hours EECP therapy over a 7 week period. EECP to be administered for 1 hour, 5 times a week.
16165542|NCT01659372|Radiation|low level laser therapy|
16165543|NCT01659372|Drug|Naproxen|
16165544|NCT01659359|Device|Virtual reality glasses and Lidocaine|The samples were randomly allocated to use Virtual reality glasses and 5 ml Lidocaine2% for decreasing pain and anxiety in episiotomy repair.
16165545|NCT01659359|Drug|Lidocaine|The samples were randomly allocated to use 5 ml Lidocaine2% for decreasing pain and anxiety in episiotomy repair.
16165546|NCT01659346|Procedure|Endoscopic Variceal Ligation|Endoscopic Variceal Ligation every 3 weeks till eradication.
16165547|NCT01659346|Drug|Carvedilol|Carvedilol 3.125mg BD increased after 1 week to reach 6.25mg BD
16165548|NCT01659320|Drug|Minocycline|Minocycline 100 mg twice daily for 8 weeks
16165549|NCT01659307|Drug|Aspirin 75mg|Subjects randomised to aspirin 75mg will receive 1 container containing aspirin 75mg and 1 container containing placebo for the morning and 2 containers containing placebo for the evening. Subjects will take one capsule from each container in the morning and one capsule from each container in the evening.
16165550|NCT01659307|Drug|Lactose powder|Subjects randomised to placebo will receive 4 containers of placebo, 2 containers containing placebo for the morning and 2 containers containing placebo for the evening. Subjects will take one capsule from each container in the morning and one capsule from each container in the evening.
16165551|NCT01659307|Drug|Aspirin 1200mg|Subjects randomised to aspirin 600mg 12 hourly will receive 2 containers of aspirin 300mg each for the morning and 2 containers of aspirin 300mg each for the evening. Subjects will take one capsule from each container in the morning and one capsule from each container in the evening.
16165552|NCT01659294|Behavioral|Nurse Case Management|
16165553|NCT01659294|Behavioral|standard diabetologist care|routine care by diabetologist & team
16165554|NCT01659281|Drug|Artesunate|6 mg/kg/day for 2 days (total dose 12 mg/kg)
16165555|NCT01659281|Drug|Artesunate|4 mg/kg/day for 3 days
16165556|NCT01659281|Drug|Mefloquine|15mg/kg at T=0 and 10 mg/kg 6-24 hours later
16165557|NCT01659281|Drug|Mefloquine|8 mg/kg daily for 3 days
16165558|NCT01659268|Other|Simulation class|"The students will be submitted a simulation scenario in laboratory with low-fidelity mannequin for 60 minutes, in subgroups of 4-5 students. The simulated condition is a patient in respiratory failure which need of emergency interventions.
~The approach concepts of anatomic, physiology and clinical interventions using LMA will be discussed during simulation."
16165641|NCT01658657|Drug|metoprolol|
16165559|NCT01659268|Other|Exhibition-dialogued class|"The students randomized to CG will be submitted to exhibition-dialogued class with duration of 60 minutes; after this, will go to practical activity in skill lab using the low-fidelity mannequin with duration of 35 minutes.
~Each subgroup will be composed of 5-6 students for the practice activity which will last 45 minutes."
16165560|NCT01659255|Drug|Tirabrutinib|Capsules administered orally
16165561|NCT01659242|Drug|Methotrexate plus sulfasalazine|"ARM 1(Methotrexate(MTX) plus Sulfasalazine(SSZ))
~SSZ:Oral form, 2g/day, with escalation regime starting from 1g/day for the first week and increase to 1.5g/day in the next week and increasing to 2g/day by the third week. Total treatment period is 16 weeks. After reaching 2g/day, if patients conditions warrants (and no contraindication), SSZ may be increased at 0.5g per clinic visit) up to a maximum of 3g/day.
~MTX:Kept at the highest optimal dose."
16165562|NCT01659242|Drug|Leflunomide|"ARM 2:Leflunomide(LEF)
~LEF: Oral form, 20mg every other day for first 2 weeks then increasing to 20mg per day by the third week. Total treatment period is 16 weeks.
~Methotrexate:Off"
16165563|NCT01659203|Radiation|IG-IMPT|Daily, Monday-Friday for about 6 weeks
16165564|NCT01659203|Radiation|IG IMRT|Daily, Monday-Friday for about 6 weeks
16165565|NCT01659190|Other|Oiled-limestone liniment|
16165566|NCT01659177|Drug|LY2140023|Administered orally
16165567|NCT01659164|Behavioral|Group treatment for adults with ADHD|14 weeks of group treatment for adults with ADHD
16165568|NCT01659151|Drug|High Dose Interleukin-2 (IL-2)|A high dose regimen of IL-2 will be given after participants receive the infusion of the T-cells.
16165569|NCT01659151|Procedure|ACT with TIL Infusion|Special immune T-cells will be taken from a sample of the participant's tumor tissue that will be surgically removed. Certain parts of these cells will be multiplied, or grown, in the laboratory. They will then be given back to the participant by an infusion in their veins. These cells are called tumor infiltrating lymphocytes (TIL).
16165570|NCT01659151|Drug|Vemurafenib|Vemurafenib is used to slow the growth of certain types of cancer cells. This drug will be given for about 3 weeks while T-cells are being grown in the lab and then again after T-cell infusion for up to 2 years.
16165571|NCT01659151|Drug|Lymphodepletion|"The purpose of lymphodepletion in this study is to temporarily reduce the number of normal lymphocytes circulating in the participant's body before they are given the T-cells that were grown in the lab. This is so that there will be more space for the lymphocytes (T-cells) that will be infused in their veins. Fludarabine and cyclophosphamide, 2 types of chemotherapy drugs will be used for what is called lymphodepletion."
16165572|NCT01659138|Drug|SAR339658|"Pharmaceutical form:solution for infusion
~Route of administration: intravenous"
16165573|NCT01659138|Other|Placebo|"Pharmaceutical form: solution for infusion
~Route of administration: intravenous"
16165574|NCT01659125|Behavioral|"OCFighter"|OCFighter™ s an interactive, internet guided self-help (GSH) treatment program for obsessive-compulsive disorder (OCD). It uses the evidence based approach known as Cognitive Behavioral Therapy (CBT) and was adapted from the previously validated BT STEPS program for OCD. The program teaches the best practice CBT technique to help with OCD called exposure with ritual prevention (ERP).
16165575|NCT01659112|Other|Core Stabilization|A 6-week (3 days a week) exercise intervention including progressive core exercises was performed.
16165576|NCT01659112|Other|Traditional upper extremity rehabilitation|A 6-week (3 days a week) exercise intervention of the injured joint based on the recovery process was performed.
16165577|NCT01659099|Drug|GA101|in GA-ACBVP or in GA-CHOP 1000 mg on D1 and D8 (D8 in cycle 1 and 2)
16165578|NCT01659099|Drug|Rituximab|in R-ACBVP or in R-CHOP 375 mg/m² on D1
16165579|NCT01659099|Drug|Doxorubicin|in ACBVP : 75 mg/m² on D1 in CHOP : 50 mg/m² on D1
16165580|NCT01659099|Drug|Cyclophosphamide|in ACBVP : 1200 mg/m² on D1 in CHOP : 750 mg/m² on D1
16165581|NCT01659099|Drug|Prednisone|in ACBVP : 60 mg/m² from D1 to D5 in CHOP : 40 mg/m² from D1 to D5
16165582|NCT01659099|Drug|Bleomycin|in ACBVP 10 mg from D1 to D5
16165583|NCT01659099|Drug|Vindesin|in ACBVP 2 mg/m² from D1 to D5
16165584|NCT01659099|Drug|Vincristine|in CHOP 1,4 mg/m² on D1
16165585|NCT01659086|Biological|Investigational H9N2 vaccine GSK2654911A|2 or 3 doses of GSK2654911A (different formulations) followed by 1 or 0 dose of saline placebo respectively, depending in the treatment group. All doses to be administered intramuscularly (IM) in deltoid region of arm.
16165586|NCT01659086|Biological|Investigational H9N2 vaccine GSK2654909A|2 or 3 doses of GSK2654909A followed by 1 or 0 dose of saline placebo, respectively (treatment 5). All doses to be administered IM in deltoid region of arm.
16165587|NCT01659086|Biological|Placebo|1 dose of saline placebo administered intramuscularly (IM) in deltoid region of arm.
16165588|NCT01659073|Procedure|Caloric Vestibular Stimulation|
16165589|NCT01659060|Other|Flavanol-rich dark chocolate|The primary objective of this pilot RCT is to test the feasibility of design methods and procedures for later use on a larger scale. The secondary objective is to examine the acute and chronic effect of dark chocolate on endothelial function and blood pressure, among healthy pregnant women.
16165590|NCT01659060|Other|Placebo Chocolate|Placebo intervention
16165591|NCT01659047|Drug|GS-1101|150 mg taken twice daily by mouth
16165592|NCT01659034|Drug|Thienopyridine for 3 months|
16165593|NCT01659021|Drug|Idelalisib|150 mg tablets administered orally twice daily
16165594|NCT01659021|Drug|Ofatumumab|Administered intravenously
16165595|NCT01659008|Drug|Estradiol|
16165596|NCT01659008|Drug|Lysteda|
16165597|NCT01658995|Drug|Doxycycline|Doxycycline 100 mg oral capsules twice daily for 10 days. After 10 days, an additional Secondary treatment may be requested.
16165598|NCT01658995|Drug|Placebo|Placebo, one capsule orally twice daily for 10 days. After 10 days, an additional Secondary treatment may be requested.
16165599|NCT01658982|Other|cardiopulmonary exercise testing|3 minute step test compared to 6 minute bicycle test
16165600|NCT01658956|Drug|GCSF administration on days 8 and 12 after chemotherapy|
16165601|NCT01658943|Drug|Akt Inhibitor MK2206|Given PO
16165602|NCT01658943|Drug|Fluorouracil|Given IV
16165603|NCT01658943|Drug|Oxaliplatin|Given IV
16165604|NCT01658943|Drug|Selumetinib|Given PO
16165642|NCT01658657|Drug|lisinopril/hydrochlorothiazide|This is a combination pill
16166449|NCT01652664|Drug|Travoprost 0.004% PQ ophthalmic solution|
16165605|NCT01658930|Procedure|Radical Hysterectomy + pelvic lymph node dissection|This procedure may be performed abdominally, laparoscopically, robotically or vaginally. The uterus, cervix, medial 1/3 of parametria, 2cm of the uterosacral ligaments and upper 1-2cm of the vagina are to be removed en bloc. The uterine artery is ligated laterally to the ureters and the ureters are unroofed to the ureterovesical junction.
16165606|NCT01658930|Procedure|Simple hysterectomy + pelvic lymph node dissection|This procedure may be performed abdominally, laparoscopically, robotically or vaginally. Extrafascial hysterectomy involves removal of the uterus with cervix without adjacent parametria. The uterine arteries are transected medial to the ureters at the level of the isthmus and the uterosacral ligaments are transected at the level of the cervix. Surgeons should pay special attention to make sure that the whole cervix is removed. As such, a maximum of 0.5 cm of vaginal cuff can be removed to ensure the complete removal of the cervix.
16165607|NCT01658904|Drug|Carfilzomib|
16165608|NCT01658904|Drug|Melphalan|
16165609|NCT01658904|Drug|Filgrastim|
16165610|NCT01658891|Drug|combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg|beclomethasone dipropionate 50µg + formoterol fumarate 6µg, 2 inhalations b.i.d. for 2 weeks
16165611|NCT01658891|Drug|free combination of beclomethasone dipropionate 100µg + Formoterol fumarate 6µg|beclomethasone dipropionate 100µg, 1 inhalation b.i.d. for 2 weeks and formoterol fumarate 6µg, 2 inhalations b.i.d. for 2 weeks
16165612|NCT01658878|Biological|Nivolumab|
16165613|NCT01658878|Drug|Sorafenib|
16165614|NCT01658878|Drug|Ipilimumab|
16165615|NCT01658878|Drug|Cabozantinib|
16165616|NCT01658852|Drug|metronidazole|
16165617|NCT01658852|Drug|Placebo|
16165618|NCT01658839|Drug|Travoprost ophthalmic solution, 0.004% (new formulation)|Travoprost ophthalmic solution, 0.004%, new formulation
16165619|NCT01658826|Drug|AIC316|oral administration
16165620|NCT01658826|Drug|Valacyclovir|oral administration
16165621|NCT01658813|Drug|5-Fluorouracil and Interferon|5-Fluorouracil Interferon-alfa-2b
16165622|NCT01658800|Biological|VAX161C vaccine|Recombinant H5 influenza vaccine, VAX161C
16165623|NCT01658787|Device|Endovascular aortic repair|Treatment with Gore Endovascular Aortic Products.
16165624|NCT01658774|Drug|Albendazole|Single 400mg dose
16165625|NCT01658774|Dietary Supplement|Vitamin C|500 mg Vitamin C
16165626|NCT01658761|Procedure|vitrectomy|Surgery
16165627|NCT01658748|Device|Week 0 Medtronic 3387 electrodes/Activa PC amygdala DBS|Subjects undergo the placement of a Leksell (Elekta, Atlanta, GE) stereotactic frame. Electrode trajectory planned using stereotactic software (BrainLab, Germany). Traditional trans-frontal trajectory used to implant Medtronic #3387 DBS electrodes bilaterally in the BLn. A curvilinear incision will be made 3 cm lateral to midline and 1 cm in front of the coronal suture. A burr hole will be placed with a high-speed drill for placement of a Stimloc device to hold the electrode in place. The dura will be opened, coagulated back and the cortex exposed, coagulated, and pierced. The electrode will be introduced using a cannula. Each electrode contact will be stimulated up to 7 V to confirm the absence of immediate side effects; first left, then right. Electrode wires will be tunneled under skin to upper chest and connected to Medtronic Activa PC dual channel pulse generator. Both groups keep stimulators off until week 0, then this group has stimulators turned on.
16165628|NCT01658748|Device|Week 12 Medtronic 3387 electrodes/Activa PC amygdala DBS|Subjects undergo the placement of a Leksell (Elekta, Atlanta, GE) stereotactic frame. Electrode trajectory planned using stereotactic software (BrainLab, Germany). Traditional trans-frontal trajectory used to implant Medtronic #3387 DBS electrodes bilaterally in the BLn. A curvilinear incision will be made 3 cm lateral to midline and 1 cm in front of the coronal suture. A burr hole will be placed with a high-speed drill for placement of a Stimloc device to hold the electrode in place. The dura will be opened, coagulated back and the cortex exposed, coagulated, and pierced. The electrode will be introduced using a cannula. Each electrode contact will be stimulated up to 7 V to confirm the absence of immediate side effects; first left, then right. Electrode wires will be tunneled under skin to upper chest and connected to Medtronic Activa PC dual channel pulse generator. Both groups keep stimulators off until week 0. This group has stimulators turned on at week 12.
16165629|NCT01658735|Device|H-Wave|Proprietary electrotherapy device using electrical stimulation of unique wave form and energy level that is delivered through transcutaneous electrodes to nerves and soft tissue for analgesic effect.
16165630|NCT01658735|Device|Transcutaneous Electrical Nerve Stimulation (TENS)|Electrotherapy device that delivers current at different frequency, amplitude, and wave form through cutaneous electrodes placed near body parts with pain for temporary analgesic effect. The study device is installed inside the same housing as the H-Wave Device and Sham Device, so that all appear the same. There are no identifying marks on the case that participants will recognize in order to maintain blinding.
16165631|NCT01658735|Device|Sham|The sham device is a TENS unit modified to have minimal electrical output. The device is installed in the same housing as the two active arms with equal weight, so that each device in the study appears identical.
16165632|NCT01658722|Drug|Bapineuzumab|
16165633|NCT01658696|Biological|ChAd63 ME-TRAP and MVA ME-TRAP|ChAd63 ME-TRAP: 5 x 10^10vp MVA ME-TRAP: 2 x 10^8 pfu heterologous prime-boost immunisation
16165634|NCT01658696|Biological|Rabies vaccine|2 x 2.5IU Verorab
16165635|NCT01658683|Behavioral|Exercise Facilitator Intervention|The 50 week intervention includes 5 small group counseling teleconferences, 3 personal telephone calls and Heart Wise Exercise program demonstrations. During the teleconferences and personal telephone calls, the facilitator discusses the importance of exercise. Participants review their activity diaries, identify barriers to exercise maintenance experienced to date and brainstorm solutions as a group. In addition, the facilitator conducts community program demonstrations at Heart Wise Exercise program locations in Ottawa and Toronto for interested participants.
16165636|NCT01658670|Behavioral|Enhanced Usual Care Group|The EUC group is provided access to the exercise facility and regular facility staff for the 18 month study period.
16165637|NCT01658670|Behavioral|HEART Camp (HC) Intervention Group|The HC intervention group will be provided access to the exercise facility for the 18 month study period and will also receive the cognitive-behavioral intervention (knowledge, attitudes, self-efficacy, behavioral self-management skills and social support) delivered using both group-based and individual-based strategies.
16165638|NCT01658657|Drug|Hydrochlorothiazide|
16165639|NCT01658657|Drug|Lisinopril|
16165643|NCT01658644|Other|Provision of Clinical Care Handout|Patients assigned to groups B or C will be provided with a paper or electronic version displaying either a list of the names and roles of their clinical care staff (group B), or a list of names and roles accompanied by the respective photograph of each clinician (group C). This document will be presented to the patient at the earliest possible time after admission to the hospital.
16165644|NCT01658631|Device|arterial pressure measurement (Nexfin, a noninvasive finger cuff system)|
16165645|NCT01658618|Biological|HP802-247|
16165646|NCT01658605|Drug|GSK1605786|500 mg twice daily administered orally
16165647|NCT01658605|Other|Placebo|500 mg twice daily administered orally
16165648|NCT01658592|Other|Deep brain stimulation|Stimulator setting is ON
16165649|NCT01658592|Other|Placebo|Stimulator setting is OFF
16165650|NCT01658579|Drug|HOE901-U300 (new formulation of insulin glargine)|
16165651|NCT01658579|Drug|Lantus (insulin glargine)|
16165652|NCT01658553|Drug|GSK1120212|GSK1120212 - placebo match oral dose on day 1 with GSK1120212 3 mg oral dose on day 15. GSK1120212 2mg and 2 tablets of GSK1120212 -placebo matched 0.5 mg oral dose daily from day 2 to day 14. 24 hour holter monitoring will be performed on day 1 and day 15 to compare the subjects cardiac repolarization while on placebo and after having received GSK1120212 for 14 days
16165653|NCT01658527|Drug|Orteronel|"Tak-700 will be administered until disease progression, diagnosis of a second malignancy, patient refusal to continue the treatment, excessive toxicity precluding further therapy according to protocol and /or according to the responsible physician.
~Upon progression, patient may stay on study medication until the initiation of a new therapy"
16165654|NCT01658527|Drug|Bicalutamide|Bicalutamide will be given at the standard daily dose of 50 mg PO (per os). Bicalutamide will be maintained until disease progression diagnosis of a second malignancy, patient refusal to continue the treatment, excessive toxicity precluding further therapy according to protocol and /or according to the responsible physician.
16165655|NCT01658514|Drug|Met DR|metformin delayed-release tablets
16165656|NCT01658514|Drug|Met XR|metformin extended-release tablets
16165657|NCT01658514|Drug|Placebo|
16165658|NCT01658501|Drug|50 mg PB1023|
16165659|NCT01658501|Drug|70 mg PB1023|
16165660|NCT01658501|Drug|100 mg PB1023|
16165661|NCT01658501|Drug|Placebo (0.9% Sodium Chloride)|
16165662|NCT01658501|Drug|Victoza®|
16165663|NCT01658501|Other|Diet and Exercise|
16165664|NCT01658501|Drug|Metformin|
16165665|NCT01658501|Drug|Sulfonylurea|
16165666|NCT01658501|Drug|Metformin and Sulfonylurea|
16165667|NCT01658488|Other|Non-fortified rice|Consumption of 2 servings of Non-fortified rice per day in women with iron deficiency anemia and measure serum iron and transferrin at baseline and end of study.
16165668|NCT01658488|Other|Iron-fortified Rice|Consumption of 2 servings of Iron-fortified rice per day in women with iron deficiency anemia and measure serum iron and transferrin at baseline and end of study.
16165669|NCT01658462|Drug|Docetaxel|75 mg/m2 IV Day 1 / 3 weeks
16165670|NCT01658462|Drug|Nintedanib|"200 mg x 2 per os daily from D2*
~*No Nintedanib on days when docetaxel is administered"
16165671|NCT01658462|Drug|Docetaxel: increase of the dose|Dose can be increased to 100 mg/m² secondarily at cycle 2 on the initiative of the investigator
16165672|NCT01658449|Other|Inhalable Hypertonic saline 7% + Hyaluronan 0.1%|Administration of Inhalable Hypertonic saline 7% + Hyaluronan 0.1% 5 ml twice a day, after bronchodilator for one month.
16165673|NCT01658449|Other|Inhalable Hypertonic saline 7%|Administration of Inhalable Hypertonic saline 7% 5 ml twice a day, after bronchodilator for one month.
16165674|NCT01658436|Drug|BEZ235 (Stage 1)|The investigational study drug used in this trial was BEZ235, which was supplied as 50mg, 200mg, 300mg, and 400mg solid dispersion sachets. Supply as 200mg and 50mg were provided for dose reduction. Patients were instructed to take the contents of one sachet of BEZ235 twice a day in the morning within 30 minutes after a light meal (breakfast).
16165675|NCT01658410|Drug|BQ-123|BQ-123 (Clinalfa, Läufelfingen, Switzerland) Dosage: 15µmol in two equal amounts (7.5µmol); in the first and last cardioplegia Route: intracoronary
16165676|NCT01658410|Drug|NaCl|NaCl, Route: intracoronary
16165677|NCT01658397|Behavioral|Fasting|Ten day fast
16165678|NCT01658358|Drug|Lapatinib|"dose level I, II 1000mg po daily
~dose level III, IV 1250mg po daily"
16165679|NCT01658358|Drug|Lipo-Dox|at the dose level reached on days 1 of a 21 days cycle. The recommended duration of combination treatment for each patient is at least 8 cycles,
16165680|NCT01658332|Other|blood samples|3 tubes (15 ml)
16165681|NCT01658319|Drug|fludarabine phosphate|Given IV
16165682|NCT01658319|Drug|methoxyamine|Given IV
16165683|NCT01658319|Other|laboratory biomarker analysis|Correlative studies
16165684|NCT01658319|Other|pharmacological study|Correlative studies
16165685|NCT01658319|Genetic|western blotting|Correlative studies
16165686|NCT01658319|Other|mass spectrometry|Correlative studies
16165687|NCT01658319|Genetic|DNA analysis|Correlative studies
16165688|NCT01658306|Procedure|remote ischemic preconditioning|RIPC consists of five 5-min cycles of right upper arm ischemia/reperfusion, induced by an automated cuff-inflator placed on the right upper arm which is inflated to 200 mmHg for 5mins followed by deflating the cuff for 5mins, each patient in the RIPC group will have the treatment twice a day for two weeks.
16165689|NCT01658306|Procedure|sham remote ischemic preconditioning|Sham RIPC consists of five 5-min cycles of right upper arm ischemia/reperfusion, induced by an automated cuff-inflator placed on the right upper arm which is inflated to 50 mmHg for 5mins followed by deflating the cuff for 5mins, each patient in the placebo RIPC group will have the treatment twice a day for two weeks.
16165690|NCT01658293|Behavioral|thermal stimulation|The heat and cold-water will be added to the thermal group for 30-40minutes a session daily,five sessions a week for six weeks.
16165691|NCT01658293|Behavioral|control group ergometer exercises|The control group will be given ergometer exercises with the similar duration as experimental group.
16165731|NCT01657955|Drug|Chlorambucil|
16165732|NCT01657942|Device|ExAblate MR Guided Focused Ultrasound|ExAblate MR Guided Focused Ultrasound - Local treatment of prostate lesions using Magnetic Resonance Imaging guided endorectally applied focused ultrasound energy.
16166724|NCT01650584|Drug|ISTA Tears|sterile ophthalmic solution
16165692|NCT01658280|Device|EBUS-TBNA|Patients allocated in the intervention group will undergo EBUS-TBNA procedure, performed in a bronchoscopy suite by the same operator under conscious sedation Three needle passes for each approachable station will be performed. The samples obtained will be examined on-site by experienced blinded cytopathologist.All specimens obtained will be send to definitive cytological and histological evaluation and the final diagnosis will be collected and reported on CRFs
16165693|NCT01658267|Other|nutritional supplement|2 servings per day
16165694|NCT01658254|Other|survey by email|"The intervention consists in an email to be sent to the sponsor and/or principal investigator of randomly assigned trials. This email will notify them that their trial's primary completion date is over a year old and will ask the reasons why they have not posted results on the registry. Several reasons will be proposed, and investigators or sponsors will be asked to reply by sending back an email or through a website where the same questions will appear. A follow-up email will systematically be sent 7 days after, with similar content (appendix2). The emails will be sent as direct emails, without attached files, with the edit subject Posting basic results. The controlled group will receive no intervention."
16165695|NCT01658241|Drug|panobinostat|40mg, three times a week, oral pill over 12 cycles, 4 weeks per cycle
16165696|NCT01658228|Drug|Donepezil|Donepezil 5mg will be given for 6 weeks and if tolerated, the dose will be increased to 10 mg per day. The dose range of 5 to 10 mg per day is the recommended dose for donepezil in the treatment of mild to moderate Alzheimer's disease.
16165697|NCT01658228|Drug|Placebo|A placebo capsule will be given to randomized subjects for the starting at week 16 and continuing for the remainder of the study. This group will not receive donepezil as treatment.
16165698|NCT01658228|Drug|Citalopram|Citalopram tablet will be given to subjects during an 8 week flexible dosing open treatment. If subjects respond to citalopram treatment they will be randomized to add-on donepezil/placebo.
16165699|NCT01658228|Drug|Venlafaxine|Venlafaxine tablet will be given to subjects during an 8 week flexible dosing open treatment if they did not respond to citalopram. If subjects respond to venlafaxine treatment they will be randomized to add-on donepezil/placebo.
16165700|NCT01658215|Drug|V0116 transdermal patch (Test treatment )|
16165701|NCT01658215|Drug|Nicotine transdermal patch (Reference treatment )|
16165702|NCT01658202|Drug|V0116 transdermal patch (Test treatment )|
16165703|NCT01658202|Drug|Nicotine transdermal patch (Reference Treatment )|
16165704|NCT01658176|Drug|PF-04691502|PF-04691502 administered orally at 8 mg as a continuous daily dosing schedule
16165705|NCT01658176|Drug|Exemestane|Exemestane administered orally at 25 mg as a continuous daily dosing schedule
16165706|NCT01658176|Drug|Exemestane|Exemestane administered orally at 25 mg as a continuous daily dosing schedule
16165707|NCT01658150|Drug|isradipine|Isradipine is a medication that acts by blocking a specific type of receptor in the brain called a calcium channel
16165708|NCT01658137|Other|Prudent Diet|This intervention lasts 2 weeks (14 days).
16165709|NCT01658137|Other|Typical Western Diet|This intervention lasts 2 weeks (14 days).
16165710|NCT01658124|Drug|Tranexamic Acid|
16165711|NCT01658124|Drug|Placebo|
16165712|NCT01658111|Device|Robot Group|"The MIT-MANUS/InMotion2 (Interactive Motion Technologies, Inc., Watertown, MA, USA) system has two translational degrees of freedom (dof): shoulder abduction-adduction (ab-ad), elbow flexion-extension (flexext).
~The robotic system supports the execution of reaching movements in the horizontal plane through an assist as needed control strategy. The robot can guide the movement of the upper limb of the patients and record end-effector physical quantities such as the position, velocity, and applied forces. The device is designed to have a low intrinsic end-point impedance (i.e., be back-drivable to easily carry the weight of the patient's arm, to execute movements without constraint and offer minimal resistance. A 3-dof force transducer is placed at the robots end-effector, as well."
16165713|NCT01658111|Procedure|Traditional physiotherapy|Active or passive exercises.
16165714|NCT01658098|Behavioral|edinburgh postpartum depression scale questionary|the investigators will apply the qusetionary one time only in the period of time described previously
16165715|NCT01658085|Device|ACE14S|Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with ACE14S
16165716|NCT01658085|Device|HARMONIC FOCUS®|Total thyroidectomy (total bilateral extracapsular lobectomy) for Multinodular Goiter with HARMONIC FOCUS®
16165717|NCT01658072|Procedure|Peri-Articular Injection|Use of a different analgesic protocol, based on a peri-articular injection
16165718|NCT01658072|Procedure|Epidural Patient Controlled Analgesia (Epidural PCA)|Epidural analgesia pathway.
16165719|NCT01658059|Other|Homeopathic remedy|drops of the homeopathic remedy will be taken twice a day before the treatment and once on the morning of the treatment day.
16165720|NCT01658059|Other|Placebo|drops of the placebo will be taken twice a day before the treatment and once on the morning of the treatment day.
16165721|NCT01658046|Other|Neuromuscular electrical stimulation|Bilateral quadriceps NMES using a four-channel portable electrical stimulator. Biphasic symmetric constant current impulses with a pulse width 300 µs, a frequency of 50 Hz, and duty cycle of 10 s on and 20 s off was applied for 20 min per day, 2 days per week for 10 weeks.
16165722|NCT01658046|Other|Endurance training|Endurance training consists of 30 minutes of aerobic exercise (15 minutes on treadmill and 15 minutes on stationary bicycle) at 80% of maximal heart rate
16165723|NCT01658046|Other|Quadriceps strength training|Quadriceps resistance training was applied using free weights for 2 days per week for 10 weeks according to 1 repetition maximum, starting at 45% for two sets.
16165724|NCT01658033|Drug|Avastin + mFOLFOX6|"mFOLFOX6 regimen, repeated every 2 weeks: Oxaliplatin 85 mg/m2，ivgtt； Leucovorin 400 mg/m2,ivgtt； 5-FU 400 mg/m2，iv，and then 2400 mg/m2，civ46h；
~Avastin: Avastin 5mg/kg q2w or 7.5mg/kg q3w"
16165725|NCT01658020|Drug|Zabofloxacin|Zabofloxacin 367mg tablet P.O. once daily for 5days and then Placebo P.O. once daily for 2days
16165726|NCT01658020|Drug|Moxifloxacin|Moxifloxacin 400mg tablet P.O. once daily for 7days
16165727|NCT01658007|Drug|Sirolimus|Adding sirolimus to established induction and consolidation chemotherapy for relapsed/refractory acute lymphoblastic leukemia
16165728|NCT01657994|Other|Combined functional electrical stimulation and robotic gait training|up to 18 sessions of approximately 45 minutes occurring over up to 9 weeks
16165729|NCT01657981|Drug|YM150|14C-labeled YM150, oral solution
16165730|NCT01657955|Drug|Bendamustine Hydrochloride Injection|
16165733|NCT01657929|Biological|H5-VLP + GLA-AF|H5-VLP antigen and GLA-AF adjuvant. 2 injections at Days 0, and 21.
16165734|NCT01657929|Biological|H5-VLP alone|H5-VLP antigen alone. 2 injections at Days 0, and 21.
16165735|NCT01657929|Biological|H5-VLP + Alhydrogel(R)|H5-VLP antigen and Alhydrogel(R) adjuvant. 2 injections at Days 0, and 21.
16165736|NCT01657929|Biological|Licensed H5N1 vaccine|Licensed H5N1 vaccine. 2 injections given on Days 0 and 21.
16165737|NCT01657903|Drug|Sodium Fluoride|Toothpaste containing 1450 ppm F - EU level as NaF.
16165738|NCT01657903|Drug|Potassium nitrate|All study treatments contain 5% w/w KNO3.
16165739|NCT01657890|Drug|isavuconazole|oral
16165740|NCT01657877|Drug|Calcium sodium phosphosilicate|CSP high percentage weight by weight
16165741|NCT01657877|Drug|Sodium monoflurophosphate|500 to 1500 parts per million (ppm) of fluoride
16165742|NCT01657877|Drug|Placebo|No CSP and no fluoride
16165743|NCT01657864|Drug|Lamotrigine|Lamotrigine is an anticonvulsant drug used in the treatment of epilepsy and bipolar disorder
16165744|NCT01657851|Drug|dutasteride/tamsulosin|Duodart® 0.5 mg / 0.4 mg - 1 dose at Day 1 of each treatment period. There are 2 treatment periods separated by approximately a 28-day washout period. All study drugs will be administered orally as capsules
16165745|NCT01657851|Drug|dutasteride|Avodart® 0.5 mg together with Omnic® 0.4 mg - 1 dose at Day 1 of each treatment period. There are 2 treatment periods separated by approximately a 28-day washout period. All study drugs will be administered orally as capsules
16165746|NCT01657851|Drug|tamsulosin|Omnic® 0.4 mg together with Avodart® 0.5 mg - 1 dose at Day 1 of each treatment period. There are 2 treatment periods separated by approximately a 28-day washout period. All study drugs will be administered orally as capsules
16165747|NCT01657838|Drug|Isavuconazole|oral
16165748|NCT01657838|Drug|Ketoconazole|oral
16165749|NCT01657825|Drug|Isavuconazole|oral
16165750|NCT01657825|Drug|Warfarin|oral
16165751|NCT01657812|Drug|dexmedetomidine|"Dexmedetomidine, an alpha 2 agonist provides sedative, anxiolytic, anti-shivering, analgesic, and anaesthetic sparing effect. In addition α2-adrenoceptor agonists reduce central sympathetic outflow and attenuate the stress response associated with surgery.Unlike epidural anaesthesia, dexmedetomidine is easy to administer and no potential for neurological damage.
~Date suggest that the dexmedetomidine reduces the stress response of surgery to the similar extent to epidural anaesthesia when used in conjunction with a standard general anaesthesia for abdominal surgery."
16165752|NCT01657799|Drug|Veliparib|Veliparib capsules for oral administration
16165753|NCT01657799|Drug|Placebo|Placebo to veliparib capsules for oral administration
16165754|NCT01657799|Radiation|Whole brain radiation therapy|30.0 grays (Gy) of WBRT given in 10 daily fractions of 3.0 Gy each, excluding weekends and holidays
16165755|NCT01657786|Dietary Supplement|administration of ondanstron and screening of genomic DNA|Thirty minutes before the end of surgery, ondansetron 0.1 mg/kg is administered intravenously. We assess an episode of PONV at first 2 h and 2-24 h after surgery. Genomic DNA was prepared and screened. The incidence of PONV is compared among genotypes in 5-HT3 receptor gene polymorphisms (5-HT3a: S253N; 5-HT3b: Y129S, -100_-102delAAG).
16165756|NCT01657773|Other|Ultrasound examination and Colonoscopy examination|
16165757|NCT01657760|Drug|citalopram|citalopram, 40 mg IV, vs. saline control, each to be administered in a double-blinded, within-subjects design.
16165758|NCT01657747|Other|Whole body diffusion-weighted MRI|"MRI is a technique based on magnetic fields and does not require the use of ionizing radiation. Although there are no known side effects associated with MRI, a few precautions should be taken because of the 3T magnetic field. This implicates that all metal and magnetized objects must be removed from the patient before entering the MRI room. Patients with a pacemaker, a cardiac defibrillator or other implanted conductors/prostheses are for this reason not eligible for the study.
~During the whole body MRI examination, an intravenous contrast agent will be administered. In most cases, patients do not experience any discomfort and the use of this contrast agent is part of the clinical routine.
~During the whole body MRI examinations, a bowel relaxing injection (Buscopan) is also needed to reduce movement of the intestines."
16165759|NCT01657734|Other|MR imaging|MR imaging
16165760|NCT01657721|Behavioral|Cogmed Working Memory Training Program|The Cogmed Working Memory Training Program will be used as the experimental program because of preliminary evidence indicating its effectiveness in enhancing WM and reducing behavioural symptoms of inattention/hyperactivity in children. This software-based training program was designed to improve WM abilities, particularly in children with ADHD or severe attention problems. It includes a set of auditory verbal and visual-spatial WM tasks presented via computer. All tasks involve: maintenance of simultaneous mental representations of multiple stimuli, unique sequencing of stimulus order in each trial and progressive adaptation of difficulty level as a function of individual performance.
16165761|NCT01657708|Other|Shared Decision Making|
16165762|NCT01657682|Drug|Crenolanib besylate|"Crenolanib besylate, 100 mg TID, taken orally at least 30 minutes pre- or post- meal. Patients will complete a daily diary to record the date, time and amount (number of tablets) of crenolanib taken and eating schedule.
~Concurrent hydroxyurea (maximum 5g total daily dose x 14 days) is permitted during the first 28 days of study therapy."
16165763|NCT01657669|Drug|Intravitreal Aflibercept injection|Intravitreal Aflibercept injection 2.0 mg dosed every 4 weeks (monthly) for the first 3 months followed by 2.0 mg (0.05mL) via intravitreal injection once every 8 weeks (2 months). Dosing at monthly intervals is allowed if needed in the opinion of the investigator based on presence of fluid on OCT and/or a decrease in visual acuity of 5 letters or more from the best previous visit.
16165764|NCT01657656|Dietary Supplement|Vitamin D|
16165765|NCT01657643|Dietary Supplement|Probiotics|
16165766|NCT01657643|Dietary Supplement|placebo|
16165767|NCT01657630|Device|Accu-Chek Combo System|12 weeks using the Accu Chek Combo System, which is an insulin pump system that offers a remote control integrating a bolus calculator, a blood glucose meter, data storage and analysis function.
16165801|NCT01657370|Drug|MK-1602|"Three administrations of the same dose of MK-1602 on separate days. All 3 doses are either 1, 10, 25, 50 or 100 mg of MK-1602. Dose 1: Taken at onset of migraine of moderate or severe intensity. Dose 2: Taken the evening before Visit 2. Dose 3: Taken at Visit 2, which is Day 4 post migraine treatment (Dose 1).
~Dosage form is film coated tablet for oral administration."
16166725|NCT01650584|Drug|Systane|Sterile ophthalmic solution
16165768|NCT01657617|Radiation|Boost Stereotactic Body Radiation Therapy|"The dose and fractionation scheme utilized will be based on the location of the patient's residual disease. For patients with:
~Peripheral Tumors: Treatment will consist of 2 fractions of radiation, with a minimum of 40 hours separating each fraction. Two fractions of 10 Gy with inhomogeneity correction will be delivered to the prescription line at the edge of the PTV for a total of 20 Gy. This will yield a total BED of 110 Gy.
~Medial Tumors: Treatment will consist of 3 fractions of radiation, with a minimum of 40 hours separating each fraction. Three fractions of 6.5 Gy with inhomogeneity correction will be delivered to the prescription line at the edge of the PTV for a total of 19.5 Gy. This will yield a total BED 102.2 Gy."
16165769|NCT01657604|Drug|Peginterferon α2b|Patients will receive nilotinib 300 mg BID given as two 150 mg capsules twice daily with at a starting target dose of 30μg/week. After confirmed MMR or at least 24 mo. after start of therapy, maintenance therapy (nilotinib will be discontinued) will start for a study duration of up to 5 years.
16165770|NCT01657604|Drug|Nilotinib|Patients will receive nilotinib 300 mg BID given as two 150 mg capsules twice daily for a study duration of up to 5 years.
16165771|NCT01657591|Drug|XL888|Level -1: XL888 30 mg; Level 1: XL888 30 mg; Level 2: XL888 45 mg; Level 3: XL888 90 mg; Level 4: XL888 135 mg
16165772|NCT01657591|Drug|Vemurafenib|Level -1: Vemurafenib 720 mg; Level 1: Vemurafenib 960 mg; Level 2: Vemurafenib 960 mg; Level 3: Vemurafenib 960 mg; Level 4: Vemurafenib 960 mg
16165773|NCT01657578|Drug|Omeprazole|administration of Omeprazole
16165774|NCT01657552|Drug|Eltrombopag|Each tablet contains 100 mg of Eltrombopag (Dose 200 mg)
16165775|NCT01657552|Drug|Boceprevir|Each capsule contains 200 mg of Boceprevir (Dose 800 mg)
16165776|NCT01657552|Drug|Telaprevir|Each tablet contains 375 mg of Telaprevir (Dose 750 mg)
16165777|NCT01657539|Dietary Supplement|Yogurt containing probiotics|patients assigned to this group will use a yogurt containing Bifidobacterium animalis once a day during 14 days before evaluation of the outcomes.
16165778|NCT01657539|Dietary Supplement|Placebo yogurt|Patients will use a yogurt without probiotics once a day during 14 days before evaluation of outcomes
16165779|NCT01657526|Biological|GSK Biologicals' Non-Typeable H. influenzae (GSK2838500A)|Administered intramuscularly (IM) in the deltoid region of non-dominant arm
16165780|NCT01657526|Biological|GSK Biologicals' Non-Typeable H. influenzae (GSK2838501A)|2 doses administered IM in the deltoid region of non-dominant arm
16165781|NCT01657526|Biological|Saline placebo|2 doses administered IM in the deltoid region of non-dominant arm
16165782|NCT01657513|Drug|subjects will receive either infliximab, adalimumab or etanercept|"The subjects receive treatment with a tnf-alfa blocking according to the official guidelines for the particular drug.
~The study subjects will receive treatment with one drug only -
~infliximab or
~adalimumab or
~etanercept
~The consulting dermatologist decides which drug to use according to official guidelines"
16165783|NCT01657500|Other|Corneal donor storage in Optisol GS media solution|Donor tissue is preserved in the Optisol media until ready for implantation
16165784|NCT01657500|Other|Life 4°C solution for cornea storage|Donor cornea is stored in the Life 4°C media prior to implantation.
16165785|NCT01657487|Drug|Fluticasone/Salmeterol high dose|
16165786|NCT01657474|Other|Weekly application of EpiFix plus standard of care|
16165787|NCT01657474|Other|Biweekly application of EpiFix plus standard of care|
16165788|NCT01657461|Drug|Intravenous (IV) recombinant human tissue plasminogen activator (rtPA)|Standard therapy with Intravenous (IV) recombinant human tissue plasminogen activator (rtPA)
16165789|NCT01657461|Device|Solitaire revascularization device|Clot retrieval with the Solitaire revascularization device after patients have received standard therapy with intravenous tissue plasminogen activator
16165790|NCT01657448|Drug|Methenamine and Methylthioninium chloride|• Ingesting two (02) tablets of the drug with a glass of water, every 8 hours for 3 days
16165791|NCT01657448|Drug|Phenazopyridine|• Ingesting two (02) tablets of the drug with a glass of water, every 8 hours for 3 days
16165792|NCT01657435|Device|Ceramax Acetabular System|28mm Ceramic-on-ceramic Acetabular Cup System
16165793|NCT01657422|Behavioral|PACE+|Patients assigned to the intervention group will receive intervention strategies over a the course of 2 years including: (1) completion of a 45-minute office-based computer program resulting in an assessment and action plan for improvement in physical activity and nutrition behaviors; (2) a provider counseling session immediately following the computerized assessment, followed by (3) 12 phone calls and 24 mailings over a 24-month period conducted by PACE+ staff members
16165794|NCT01657409|Drug|BoNT-A (10 injection)|BoNT-A 100 U 10 injections
16165795|NCT01657409|Drug|BoNT-A (20 injection)|BoNT-A 100 U 20 injections
16165796|NCT01657409|Drug|BoNT-A (40 injection)|BoNT-A 100 U 40 injections
16165797|NCT01657396|Procedure|Standard Oral Hygiene|Current local standard of care - minimum q2h mouthcare with a green Toothette swab dipped in sterile water, with excess liquid aspirated using a Yankauer suction. Brushing of teeth (if applicable) with a toothbrush and standard toothpaste q12h. Replacement of Yankauer suction device daily.
16165798|NCT01657396|Procedure|SAGE Q-care q2|Oral hygiene provided with a commercial pre-packaged product (SAGE Q-care q2 Oral Cleansing and Suctioning System) - minimum q2h mouthcare using the supplied applicator swabs and covered Yankauer suction device using supplied Perox-A-Mint (a hydrogen peroxide based oral hygiene solution) alternating with alcohol-free mouthwash. Brushing of teeth (if applicable) with supplied applicator using Antiplaque solution (a cetylpyridinium based solution) q12h. Use of a new kit (which includes new covered Yankauer suction device) daily.
16165799|NCT01657396|Procedure|SAGE Q-care q2 with Chlorhexidine|Oral hygiene provided with a commercial pre-packaged product with chlorhexidine (SAGE Q-care Rx q2 Oral Cleansing and Suctioning System with CHG) - minimum q2h mouthcare using the supplied applicator swabs and covered Yankauer suction device using supplied Perox-A-Mint (a hydrogen peroxide based oral hygiene solution) alternating with alcohol-free mouthwash. Brushing of teeth (if applicable) with supplied applicator using chlorhexidine oral rinse (solution containing 0.12% chlorhexidine) q12h. Use of a new kit (which includes new covered Yankauer suction device) daily.
16165800|NCT01657383|Procedure|HPB Surgery|Hepatopancreatico Biliary Surgery
16165839|NCT01657084|Device|Dummy mask|The dummy mask is similar in appearance to the treatment mask, but causes only a negligible change in blood gases
16165840|NCT01657071|Drug|YH14659|YH14659 capsule by oral
16166914|NCT01649258|Drug|fosaprepitant dimeglumine|Given IV
16165802|NCT01657370|Drug|Placebo|"Three administrations of placebo for MK-1602 on separate days. Dose 1: Taken at onset of migraine of moderate or severe intensity. Dose 2: Taken the evening before Visit 2. Dose 3: Taken at Visit 2, which is Day 4 post migraine treatment (Dose 1).
~Dosage form is film coated tablet for oral administration."
16165803|NCT01657370|Drug|Rescue medication|"If moderate or severe migraine headache pain continues 2 hours after dose of study medication or if migraine headache comes back within 48 hours,
~Participants will be allowed to take their own rescue migraine medication, which may include analgesics (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs]), anti-emetics, triptans, opiates or other medication not explicitly excluded."
16165804|NCT01657357|Other|Routine followup|questionnaires
16165805|NCT01657331|Drug|Brentuximab Vedotin|Dose escalation in phase I of the study from 1.2-1.8 mg/kg, IV infusions over 30 minutes on day 1 of each 21-day cycle.
16165806|NCT01657331|Drug|Bendamustine|Dose escalation in phase I of the study from 60-100 mg/m2, IV infusion on days 1 and 2 of each 21-day cycle.
16165807|NCT01657331|Drug|Neulasta|(Non-experimental) Standard procedure prophylactic pegfilgrastim on day 3 of any subsequent cycle after cycle 1, or filgrastim for 5 to 10 days, per investigator's discretion.
16165808|NCT01657318|Other|Olivamine containing wound care products|Continuous wound care with Olivamine containing products until wound closure. Intake of dietary supplement of 1 capsule for 60 days.
16165809|NCT01657305|Drug|Oleogel-S10, non-adhesive wound dressing|1 cm or 100 mg Oleogel-S10 per cm2 wound area (corresponds to thickness of approximately 1 mm or 0.04 inch) every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28.
16165810|NCT01657305|Device|Non-adhesive wound dressing only|Soft silicone faced polyurethane foam dressing such as Mepilex® only every 3 to 4 days until 95% epithelialization of the wound or end of treatment at Day 28.
16165811|NCT01657292|Drug|Oleogel-S10 ointment|Intraindividual comparison: One randomly assigned wound half is treated with Oleogel-S10 ointment and fatty gauze wound dressing
16165812|NCT01657292|Device|Octenilin® wound gel|Intraindividual comparison: The other wound half is treated with Octenilin® wound gel and fatty gauze wound dressing
16165813|NCT01657279|Other|Clinical scenarios|Clinicians will be randomized to a sequence of 5 clinical scenarios with a variable range of expected outcome [i.e. from low (<10%) to high (>50%) expected risk death at 30 days].
16165814|NCT01657266|Drug|PRO-155|Pre-medication (before surgery) and maintenance treatment.
16165815|NCT01657266|Drug|Nevanac|Pre-medication (before surgery) and maintenance treatment.
16165816|NCT01657253|Drug|PRO-148|Instill 1 drop in each eye four times a day, for 60 days
16165817|NCT01657253|Drug|Systane|Instill 1 drop in each eye four times a day, for 60 days
16165818|NCT01657240|Drug|PRO-118|instill one drop in each eye once a day for 21 days
16165819|NCT01657240|Drug|Olopatadine Hydrochloride|instill one drop in each eye once a day for 21 days
16165820|NCT01657227|Behavioral|Intervention to patients|"Multifaceted intervention consisting of:
~Program of education and behavior modification: group sessions conducted by health educators for the patient and a relative (who usually do the food shopping or prepare meals) every 3 months over 2 years (total:8 sessions). Main contents: diabetes, hygiene/nutrition and physical exercise.
~Monitoring of patient conditions by Informational Communication Technologies (ICT): patient will complete at home a web-based short questionnaire once a week and an expanded version once a month.
~Short text messaging to patient's mobile based on information obtained from self-reported questionnaires. 3 types of messages: 1) Reminders for completing web-based questionnaires, the attendance at group sessions and the follow-up appointments, 2) General advice on good habits, 3) Custom messages to reinforce behavior change."
16165821|NCT01657227|Behavioral|Intervention to professionals|"Multifaceted intervention consisting of:
~Educational intervention: Two theoretical and practical sessions to update knowledge on T2DM management and provide professionals with techniques to enhance the patient-centered clinical relationship model and the shared decision making model with the ultimate goal of improving patient adherence to treatment and self-care.
~Computer-based clinical decision support system (CDSS): Implementation of an automated tool combining evidence-based knowledge with patient-specific information to assist clinicians in making clinical decisions in the management of T2DM patients.
~Feedback: periodic mailing of personalized feedback reports with data on health results of all T2DM patients who are cared by the professional."
16165822|NCT01657227|Other|Usual care|Usual care for T2DM received in primary health care
16165823|NCT01657214|Drug|SAR125844|"Pharmaceutical form:Concentrate for solution
~Route of administration: intravenous"
16165824|NCT01657201|Drug|SYP-1018 200mg|SYP-1018 200mg, Intravenous administration
16165825|NCT01657201|Drug|Voriconazole 200mg|Voriconazole 200mg, Intravenous administration
16165826|NCT01657188|Device|Cheyne-Stokes respiration by adaptive servoventilation|
16165827|NCT01657175|Other|Supportive care|"The patients will be randomized to control or supportive care groups.
~The control group will be given care as usual wich include clinical follow-ups at the surgical department.
~The supportive care group get in addition to the clinical follow-ups a supportive care programme including:
~Discharge information about surgery and life after surgery together with their relatives.
~Active telephone contacts 1/week th first month the 2/month up to six month after discharge by a specialized nurs.
~Open telephone line were the patients can call the nursed ruing daytime. Discharge: approximately 2-4 weeks after surgery"
16165828|NCT01657162|Drug|Alendronate|Alendronate is a bisphosphonate drug that prevents bone resorption by osteoclast and is used for the treatment of osteoporosis.
16165829|NCT01657149|Procedure|Lymphatic massage and individual physiotherapy|lymphatic massage and individual physiotherapy
16165830|NCT01657149|Procedure|individual physiotherapy only|individual physiotherapy only
16165831|NCT01657136|Drug|Ivabradine|comparison of different drugs
16165832|NCT01657136|Drug|Beta blocker|comparison of different drugs
16165833|NCT01657123|Other|ergometry|ergometry measurements
16165834|NCT01657123|Other|ergometry|Ergometry measurements
16165835|NCT01657110|Other|Tea tree oil|Pea-sized amount of tea tree oil medicated gel (containing 200mg/g tea tree oil) applied to the face twice daily for 12 weeks.
16165836|NCT01657097|Drug|INCS|
16165837|NCT01657097|Drug|Placebo|
16165838|NCT01657084|Device|CDA Mask|The CDA (Carbon Dioxide Accumulation) mask effectuates an increase in the inspired CO2 fraction, while allowing an adequate supply of fresh air to the patient.
16165842|NCT01657058|Dietary Supplement|Soluble viscous fibre blend powder in hydrophobic matrix|5g soluble viscous fibre blend pre-mixed into margarine (hydrophobic matrix) + white bread + jello
16165843|NCT01657058|Dietary Supplement|Soluble viscous fibre blend in pre hydrated form|0g soluble viscous fibre blend margarine + white bread +5g Konjac fibre prehydrated in jello
16165844|NCT01657058|Dietary Supplement|No soluble viscous fibre blend|0g soluble viscous fibre blend margarine + white bread + jello
16165845|NCT01657058|Dietary Supplement|Soluble viscous fibre blend premixed with ½ carbohydrate gel|Margarine + white bread (1/2 carbohydrate) +5g soluble viscous fibre blend hydrated in jello with glucose
16165846|NCT01657058|Dietary Supplement|No soluble viscous fibre blend, ½ carbohydrate jello|Margarine + white bread (1/2 carbohydrate) +5g soluble viscous fibre blend hydrated in jello with glucose
16165847|NCT01657045|Biological|JVS-100 or placebo|Injections will be delivered depending on sternal incision length.
16165848|NCT01657045|Biological|JVS-100 or placebo|Injections will be delivered depending on sternal incision length.
16165849|NCT01657045|Biological|JVS-100 or placebo|Injections will be delivered depending on sternal incision length.
16165850|NCT01657032|Dietary Supplement|Smectite|Eligible children received smectite (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
16165851|NCT01657032|Dietary Supplement|Placebo|Eligible children received placebo: glucose (3g) once a day till diarrhea stop with LGG (ATCC 53103) at a daily dosage of 6×10 9 colony forming units (CFU) in one dose for 7 days.
16165852|NCT01657032|Dietary Supplement|Lactobacillus GG|All children received LGG (ATCC 53103), dose 6×10 9 colony forming units (CFU), once a day for 7 days with placebo or smectite
16165853|NCT01657019|Drug|Lisdexamfetamine dimesylate|50 or 70 mg administered orally, once a day for 52 weeks
16165854|NCT01656980|Drug|Carmustine|As Experimental group, subjects will accept specified wafers of carmustine in the cavity while gliomas maximally be resected.
16165855|NCT01656980|Procedure|tumor resection surgery|For this group, subjects will accept routine tumor resection surgery and place no implant wafers.
16165856|NCT01656967|Device|AMBU Aura-I/aScope 2|Once ventilation is achieved, the patients in group A will be intubated through the shaft of Aura-I via the the Ambu aScope.
16165857|NCT01656967|Device|LMA Fastrach Single Use|The patients in group B will be intubated by ETT via the Intubating LMA as is standard procedure.
16165858|NCT01656954|Procedure|Passive Leg Raise (PLR)|From the supine position, the legs are elevated to 45 degrees above the resting surface for a period of 3 minutes. At completion,the legs are lowered to the resting surface.
16165859|NCT01656928|Behavioral|preschool-based nutritional intervention|6-month intervention administered once weekly by a nutrition expert consisting of joint meal preparation and activities for children and parents such as tasting and preparing nutritious, fresh foods.
16165860|NCT01656902|Drug|NOVOCART® 3D plus|Two-Step intervention: 1) cartilage cells are collected from the patient during arthroscopy 2) collected cartilage cells are cultivated in a sterile environment, seeded in an organic matrix scaffold and implanted into the defect location (knee, femur)
16165861|NCT01656902|Procedure|Microfracture|single-step treatment: defect location (knee, femur) is debrided, then bone plate is drilled mechanically to allow cells from the bone marrow to move to the defect location and to develop a scar tissue
16165862|NCT01656889|Biological|HP-802-247|HP802-247 (fibrinogen solution & thrombin solution containing living, irradiated, growth arrested keratinocytes and fibroblasts) 260 µL (130 µL, one spray, of each solution) containing 0.5 x 106 cells per mL every 14 days.
16165863|NCT01656889|Biological|Vehicle|(fibrinogen solution & thrombin solution without cells)
16165864|NCT01656876|Behavioral|Mirror box training|This protocol includes 1 hour mirror therapy and 0.5 hour functional training in a session. The treatment intensity is 1.5 hours/day, 5 days/week, for 4 weeks. MT focuses on symmetrical bimanual movements and simultaneously observing the visual feedback of the unaffected upper extremity reflected by the mirror.
16165865|NCT01656876|Other|mesh glove stimulation|The MG is a two-channel electrical stimulator providing synchronous or reciprocal sensory stimulation with variant amplitudes.
16165866|NCT01656876|Behavioral|conventional intervention|Participants in this group receive a structured protocol based on occupational therapy such as neuro-developmental techniques and task-oriented approach
16165867|NCT01656863|Other|Questionnaire|
16165868|NCT01656850|Other|Almond diet first, then NCEP Diet|whole almonds will be incorporated into a control diet which is a NCEP step 2 diet. Whole almonds will replace 20% daily calorie intake. Subjects were assigned to receive almond diet for 12 weeks after a 2-weeks run-in period. After washout 2 weeks, change diet to NCEP Diet for 12 weeks
16165869|NCT01656850|Other|NCEP diet first, then Almond diet|NCEP diet first, then Almond diet. Subjects were assigned to receive NCEP diet for 12 weeks after a 2-weeks run-in period. After washout 2 weeks, change diet to almond diet for 12 weeks
16165870|NCT01656837|Behavioral|Comprehensive Community Treatment|
16165871|NCT01656837|Behavioral|MST-BSF|
16165872|NCT01656811|Drug|levalbuterol 90 mcg|90 mcg levalbuterol delivered via MDI 2 actuations of 45 mcg QID
16165873|NCT01656811|Drug|levalbuterol 180 mcg|180 mcg levalbuterol delivered via MDI 2 actuations of 90 mcg QID
16165874|NCT01656811|Drug|racemic albuterol 180 mcg|180 mcg racemic albuterol delivered via MDI 2 actuations of 90 mcg QID
16165875|NCT01656811|Drug|Placebo|Placebo 2 actuations QID
16165876|NCT01656798|Drug|sildenafil citrate|2 mL of POS formulation of sildenafil citrate 10 mg/mL (equivalent to 20 mg dose), single dose
16165877|NCT01656798|Drug|sildenafil citrate|2 mL of POS formulation of sildenafil citrate 10 mg/mL (equivalent to 20 mg dose), single dose
16165878|NCT01656785|Drug|68Ga-BNOTA-PRGD2|Intravenous injection of one dosage of 111MBq 68Ga-BNOTA-PRGD2 solution. Tracer doses of 68Ga-BNOTA-PRGD2 will be used to image angiogenesis of cerebral infarction areas by Positron Emission Tomography / computed tomography (PET/CT)
16165879|NCT01656772|Device|Vdrive Lasso navigation|Remote robotic Lasso navigation
16165880|NCT01656772|Procedure|Manual Lasso navigation|Manually maneuver a Lasso catheter
16165881|NCT01656759|Drug|Evicel Fibrin Spray|10cc syringe dose, once at the end of TKA
16165882|NCT01656746|Procedure|therapeutic laparoscopic surgery|Undergo single incision laparoscopic surgery
16166915|NCT01649258|Other|laboratory biomarker analysis|Correlative studies
16165883|NCT01656733|Drug|Nicotrol Inhaler|Nicotrol Inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper
16165884|NCT01656733|Drug|Placebo Inhaler|Placebo inhaler, 1-12 cartridges per day, for 6 weeks with a 6 week taper
16165885|NCT01656720|Drug|1R, 2S-methoxamine hydrochloride|
16165886|NCT01656720|Drug|Placebo|
16165887|NCT01656707|Behavioral|ACRA|Ten weekly,60-minute therapy sessions including six individual, two parent/guardian and two joint (individual and parent/guardian).
16165888|NCT01656707|Behavioral|CBT|10 weekly, 60-minute sessions of augmented individualized CBT
16165889|NCT01656694|Device|DePuy Sigma HP Partial Knee|
16165890|NCT01656681|Dietary Supplement|THIAA|A tablet containing 400 mg tetrahydro iso-alpha acids, 3 times a day
16165891|NCT01656681|Dietary Supplement|Placebo|Placebo tablet
16165892|NCT01656668|Drug|BC1036|
16165893|NCT01656642|Drug|Atezolizumab|Atezolizumab will be administered q3w or q2w.
16165894|NCT01656642|Drug|Cobimetinib|Oral repeating dose
16165895|NCT01656642|Drug|Vemurafenib|Oral repeating dose, depending on arm/cohort
16165896|NCT01656629|Drug|Teriparatide|20 mcg subq daily for 3 months
16165897|NCT01656629|Drug|Alendronate|70 mg weekly for 3 months
16165898|NCT01656629|Dietary Supplement|calcium and vitamin D|
16165899|NCT01656616|Drug|Cyanide antidote administration|
16165900|NCT01656603|Biological|unlicensed CBU|infusion of unlicensed cord blood units
16165901|NCT01656590|Other|High Protein and Exercise Therapy along-with Nocturnal Enteral Feeding|"High Protein and Moderate Carbohydrate Nutrition designed by our nutritionist for every patient based on his/her nutrition requirements, age & gender
~500 cc Formula - Nutren Replete with Fiber overnight [8 hours] via gastrostomy tube
~Conditioning Exercise once daily"
16165902|NCT01656577|Drug|Pexacerfont|
16165903|NCT01656551|Drug|Gemcitabine|
16165904|NCT01656551|Drug|Pemetrexed|500 mg/m2 day 1 every 3 weeks
16165905|NCT01656551|Drug|Cisplatin|60 mg/m2 day 1 every 3 weeks
16165906|NCT01656538|Drug|Paclitaxel|
16165907|NCT01656538|Drug|Reolysin|
16165908|NCT01656525|Drug|Gantenerumab|75 mg subcutaneous doses every 4 weeks for 24 weeks
16165909|NCT01656525|Drug|Gantenerumab|105 mg subcutaneous doses every 4 weeks for 24 weeks
16165910|NCT01656525|Drug|Gantenerumab|225 mg subcutaneous doses every 4 weeks for 24 weeks
16165911|NCT01656525|Drug|Placebo|subcutaneous doses every 4 weeks for 24 weeks
16165912|NCT01656512|Drug|zolendronic acid|"patients will receive calcium & vitamin D daily in addition to bisphosphonates (zolendronic acid ) every 3 months in the dose of
~Initial dose: (0.025) mg /kg
~Subsequent doses ( 0.05) mg /kg.
~Maximum dose of 4 mg."
16165913|NCT01656512|Drug|calcium & vitamin D|patients will receive calcium & vitamin D Dose of Calcium : 1500- 2000 gram elemental Calcium daily . Dose of Vitamin D ( calcitriol; one alpha) 800-1000 International Unit
16165914|NCT01656499|Dietary Supplement|Arabinoxylanoligosaccharides|
16165915|NCT01656499|Dietary Supplement|Maltodextrine|
16165916|NCT01656486|Radiation|Stereotactic Radiation|Treatment of pancreas with 30 Gy of radiation given in 5 fractions of 6 Gy each with stereotactic radiosurgery that could produce a fibrosis of the pancreas and a decrease in the production of exocrine portion of the gland.
16165917|NCT01656473|Other|MI and DBT|One individual session of Motivational Interview followed by 12 weeks of Dialectical Behaviour Therapy group skills training
16165918|NCT01656473|Other|MI and DBT|Individual Motivational Interview session plus 12-week Dialectical Behaviour Therapy skills group
16165919|NCT01656460|Radiation|Stereotactic radiation Arm 1|"Dose Levels Dose per Fraction Total Dose
~1 8 Gy 16 Gy"
16165920|NCT01656460|Radiation|Stereotactic radiation Arm 2|Dose Levels Dose per Fraction Total Dose 2 10 Gy 20 Gy
16165921|NCT01656460|Radiation|Stereotactic radiation Arm 3|Dose Levels Dose per Fraction Total Dose 3 12 Gy 24 Gy
16165922|NCT01656460|Radiation|Stereotactic radiation Arm 4|Dose Levels Dose per Fraction Total Dose 4 14 Gy 28 Gy
16165923|NCT01656434|Drug|NOMAC-E2|NOMAC-E2 film-coated oral tablets containing 2.5 mg nomegestrol acetate and 1.5 mg 17ß-estradiol.
16165924|NCT01656434|Drug|NETA-EE|NETA-EE film-coated oral tablets containing 1 mg norethisterone acetate and 10 μg ethinylestradiol.
16165925|NCT01656434|Other|Placebo|tablet
16165926|NCT01656434|Drug|ethinylestradiol (EE)|EE 10 μg tablet
16165927|NCT01656434|Drug|ferrous fumarate|ferrous fumarate 75 mg tablet
16165928|NCT01656408|Drug|MK-8150|
16165929|NCT01656408|Drug|Placebo for MK-8150|
16165930|NCT01656395|Drug|MK-1029|MK-1029 10 mg, 30 mg or 150 mg oral tablets taken QD at bedtime, based on randomization.
16165931|NCT01656395|Drug|Montelukast 10 mg|Parts I-II: Participants will receive Montelukast 10 mg tablets QD
16165932|NCT01656395|Drug|Placebo|Parts I-II: Participants will receive Placebo tablets QD
16165933|NCT01656382|Drug|ABLC|
16165934|NCT01656369|Procedure|Group I: delorme operation only.|A circumferential incision was made in the rectal mucosa approximately 1 cm away from the dentate line. Using electrocautery, the mucosa was stripped to the apex of the prolapse. The muscular layers of the rectal wall were reduced as the mucosa was stripped. Mucosal stripping continued past the apex of the prolapse and then continued inside the prolapsed segment to a point internally that is equivalent to the point of the initial mucosal incision. The underling muscle was plicated by vicryl 2/0.The muscle bite was taken longitudinally from 8 sides to reach a horizontal line of plication at the end. The mucosa was then reanastomosed.
16165935|NCT01656369|Procedure|delorme operation with post anal repair|In group II : post anal repair was added by making transverse incision 7cm behind the anal canal.dissection of intersphincteric plain,plication of internal sphincter by using 3/0 vicryl.The levator ani and external sphincter were then sutured to each other by vicryl 2/0 behind the anal canal followed by skin closure without drain.
16165936|NCT01656356|Biological|Avian Flu Vaccine|
16165937|NCT01656356|Biological|Placebo|
16165938|NCT01656343|Drug|Calcineurin inhibitors (CNI)|No Intervention
16165939|NCT01656343|Drug|Belatacept|No Intervention
16165940|NCT01656330|Drug|Rivaroxaban 20 mg twice daily|One rivaroxaban 20 mg tablet administered twice a day (b.i.d.) for 4 days (Days 1-4). Interpretation by CTRL: Concentration type = Exact; Number = 20; unit=mg; route: oral use for 4 days.
16298104|NCT00659503|Drug|Placebo|placebo
16165941|NCT01656330|Drug|Rivaroxaban 20 mg once daily|One rivaroxaban 20 mg tablet administered once daily on Day 5. Interpretation by CTRL: Concentration type = Exact; Number = 20; unit=mg; route: oral use for 1 day.
16165942|NCT01656330|Drug|Profilnine SD|Single bolus dose of Profilnine SD 50 IU/kg administered by intravenous (IV) injection on Day 5. Interpretation by CTRL: Concentration type = Exact; Number = 50; unit=IU/kg; route: intraveous use.
16165943|NCT01656330|Drug|Beriplex P/N|Single bolus dose of Beriplex P/N 50 IU/kg administered by intravenous (IV) injection on Day 5 Interpretation by CTRL: Concentration type = Exact ; Number = 50; unit=IU/kg; route : intravenous use
16165944|NCT01656330|Other|Saline|Single 100 cc bolus of saline administered by intravenous (IV) injection on Day 5. Interpretation by CTRL: Concentration type = Exact ; Number = 100; unit=cc; route : intravenous use use.
16165945|NCT01656317|Other|Early multidisciplinary rehabilitation|"Multidisciplinary rehabilitation consist of individualized stimulation and mobilisation.
~The multidisciplinary team consists of a physician, a nurse, a physiotherapist, an occupational therapist and a clinical neuropsychologist."
16165946|NCT01656304|Biological|bevacizumab|Given IV
16165947|NCT01656304|Other|laboratory biomarker analysis|Correlative studies
16165948|NCT01656278|Procedure|Magnetic resonance imaging (MRI)|"Treatment algorithm based on conventional biochemical/clinical examinations AND MRI of unilateral 2nd to 5th MCP joints and wrist on dominant side. Assessed month 0, 4, 8, 12, 16, 20, 24 with treatment intensification after predefined treatment algorithm in the case of unsatisfactory inflammatory activity, which is defined as the presence of at least one physically swollen joint and DAS28>3.2 AND/OR MRI-detected bone marrow oedema score > 0 (RAMRIS-score)"
16165949|NCT01656278|Other|Conventional biochemical and clinical examinations|"Treatment algorithm based on conventional biochemical and clinical examinations. Assessed month 0, 4, 8, 12, 16, 20, 24 with treatment intensification after predefined treatment algorithm in the case of unsatisfactory inflammatory activity, which is defined as the presence of at least one clinically swollen joint and DAS28>3.2"
16165950|NCT01656265|Drug|ARQ 197|Daily repeating dose of oral ARQ 197, twice a day just after meals. Dose of ARQ 197 will be escalated according to 3+3 rule.
16165951|NCT01656252|Drug|Phase I- Cytarabine & Eltrombopag|"Cycle 1= Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
~Eltrombopag (Open-Label) by mouth daily until platelet recovery or for 35 consecutive days, whichever occurs first. Phase I will determine the dose and schedule of Eltrombopag to be used in Phase II.
~One cycle of consolidation therapy with high-dose cytarabine and eltrombopag will be received on study. Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
16165952|NCT01656252|Drug|Phase II- Sequence A|"Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
~Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 1st cycle of high-dose consolidation chemotherapy and placebo by mouth daily with 2nd cycle.
~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.
~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
16165953|NCT01656252|Drug|Phase II- Sequence B|"Cytarabine 3 g/m² IV twice daily on Days 1, 3 and 5 (Patients >60 years of age will receive cytarabine 1.5 g/m² IV per dose). Day 1 must start in AM.
~Placebo by mouth daily with 1st cycle of high-dose consolidation therapy and Eltrombopag by mouth daily (dose and schedule as determined in Phase I) with 2nd cycle.
~Eltrombopag/placebo will continue until platelet recovery or for 35 consecutive days, whichever occurs first.
~Additional chemotherapy may be administered at the investigators discretion without eltrombopag."
16165954|NCT01656239|Drug|fedovapagon 1 mg|
16165955|NCT01656239|Drug|fedovapagon 2 mg|
16165956|NCT01656239|Drug|fedovapagon 4 mg|
16165957|NCT01656239|Drug|Placebo ( sugar pill)|
16165958|NCT01656226|Device|Eryfotona AK-NMSC® cream|Cream, to be applied according to COLIPA standard at 2 mg/cm² in head and neck, twice a day before exposing to sun light morning and around lunchtime (about 4-6 hours later), for up to 6 months.
16165959|NCT01656226|Other|Sunscreen SPF 50+|Cream, to be applied according to COLIPA standard at 2 mg/cm² in head and neck, twice a day before exposing to sun light morning and around lunchtime (about 4-6 hours later), for up to 6 months.
16165960|NCT01656213|Device|Computer-based target pursuit task (created using E-Prime software) and visual-feedback handgrip force transducer (CurrentDesigns 2012).|Subjects will be encouraged to perform the exercise 2-3 times per dialysis session depending upon mood, although will be permitted to skip sessions if they do not feel well or motivated. The laptop program time-stamps each session, and records a time-series of duration, force and accuracy of hand grip.
16165961|NCT01656200|Biological|Live attenuated Japanese encephalitis vaccine SA14-14-2|Live attenuated Japanese encephalitis vaccine SA14-14-2
16165962|NCT01656187|Drug|Memantine 10 mg capsule|"Memantine oral capsule was initiated at 5 mg/day at Randomization (Week 0), then titrated to 5 mg twice a day at Week 2, then increased to 10 mg in the morning and 5 mg in the evening at Week 3, and then to 10 mg twice a day (intervention dose) at Weeks 4-24. For the participants in the Placebo, then Memantine arm, the same titration schedule was maintained after the 4-week washout period (Week 28-52)."
16165963|NCT01656187|Drug|Memantine-matched Placebo capsule|"Memantine-matched oral Placebo capsule was initiated at Randomization (Week 0) and maintained Weeks 0-24 in a manner consistent with the active drug titration schedule. The number of placebo capsules matched the number of active drug capsules at each titration checkpoint. For the participants in the Memantine, then Placebo arm, the same titration schedule was maintained after the 4-week washout period (Week 28-52)."
16165964|NCT01656174|Device|Procleix Dengue Virus Assay|in vitro diagnostic assay
16165965|NCT01656161|Drug|Triptorelin embonate 22.5 mg|
16165966|NCT01656148|Drug|Fampridine-SR|Subjects will all receive Fampridine-SR in an open label enrichment phase lasting four weeks. Those 40% improvin the most measured by SSST will go onto the intervention. Here randomization in a 1:1 key between Fampridine-SR and placebo will be undertaken. Treatment will be of either Fampridine-SR 10 mg BID or placebo BID for four weeks. Arms will be double blind.
16165967|NCT01656135|Other|Blood drawing for immune monitoring and questionnaires|
16165968|NCT01656122|Drug|abacavir|Dosing of ABC will be according to the WHO guidelines by weight band for twice daily dosing. The once daily dosing will use the same mg/day as the twice daily dosing for that weight band
16307117|NCT00596271|Other|Placebo|
16165969|NCT01656122|Drug|3TC|Dosing of 3TC will be according to the WHO guidelines by weight band for twice daily dosing. The once-daily dosing will use the same mg/day as the twice-daily dosing for that weight band
16165970|NCT01656109|Drug|boosted atazanavir (ATV/r)|ATV/r will be taken orally once daily with food plus standard dose of 2 NRTIs according to Thai National HIV treatment guideline
16165971|NCT01656096|Device|Renal sympathetic denervation (Symplicity ablation catheter, Medtronic Inc. Minneapolis, Minnesota, USA)|
16165972|NCT01656096|Other|Sham procedure|
16165973|NCT01656070|Drug|oral cholecalciferol 1000000 UI (vitamin D3)|
16165974|NCT01656070|Drug|Placebo|
16165975|NCT01656057|Drug|Acetaminophen|Acetaminophen dissolved in 50 ml of water
16165976|NCT01656057|Drug|Metformin|Metformin + acetaminophen dissolved in 50 ml of water
16165977|NCT01656057|Drug|Colesevelam|Colesevelam + acetaminophen dissolved in 50 ml of water
16165978|NCT01656057|Other|Cholecystokinin-8|iv. infusion of CCK-8, 24 pmol/kg/hour for the first 60 minutes
16165979|NCT01656057|Other|Saline|iv. saline infusion 40 ml/hour for the first 60 minutes
16165980|NCT01656044|Procedure|wound care management|Receive SSD
16165981|NCT01656044|Procedure|wound care management|Receive NPT
16165982|NCT01656031|Drug|clofarabine|
16165983|NCT01656031|Drug|cytarabine|
16165984|NCT01656018|Drug|TMC278, Long acting (LA)|TMC278 long acting will be administered IM to the participants as follows: a single dose of TMC278 600 mg will be administered at baseline in Arm 2A and Arm 2B; at Months 2 and 4 in Arm 5A and Arm 5B. A single dose of TMC278 900 mg will be administered at Months 2 and 4 in Arm 4A and Arm 4B. A single dose of TMC278 1200 mg will be administered at baseline in Arm 1A, Arm 1B; Arm 3A, Arm 3B, Arm 4A, Arm 4B, Arm 5A and Arm 5B; at Months 2 and 4 in Arm 3A and Arm 3B.
16165985|NCT01656005|Drug|Carvedilol|Dose titration: 3.125mg bid for 1 week, 6.25mg bid for 1 week, 12.5mg bid for 4 weeks.
16165986|NCT01656005|Drug|Bisoprolol|Dose titration: 1.25mg od for 1 week, 2.5mg od for 1 week, 5mg for 4 weeks.
16165987|NCT01656005|Drug|Beclometasone/formoterol|2 puffs bid for first 5 weeks in each treatment arm
16165988|NCT01656005|Drug|Tiotropium|1 puff daily for first 4 weeks of each treatment arm
16165989|NCT01656005|Drug|Beclometasone|2 puffs bid for final week (week 6) of each treatment arm
16165990|NCT01655992|Drug|capecitabine|2500mg／m2／day divided into twice two weeks on one week off
16165991|NCT01655992|Drug|S1 generic|40mg／m2 bid four weeks on two weeks off
16165992|NCT01655979|Dietary Supplement|Whey Protein + Potassium bicarbonate|0.6 mmol WP/kg body weight + 90 mmol KHCO3 during bed rest
16165993|NCT01655979|Other|Control|Bed rest without dietary supplement
16165994|NCT01655966|Drug|vitamin D +pegylated interferon + ribavirin|Vitamin D: 1mcg once daily 48 weeks Pegylated interferon 160ug once weekly 48 weeks Ribavirin(> 75kg:1200 mg, <75kg:1000mg daily)48 weeks
16165995|NCT01655966|Drug|pegylated interferon + ribavirin|pegylated interferon 160ug once weekly Ribavirin (> 75kg:1200 mg, <75kg:1000mg daily)48 weeks
16165996|NCT01655953|Dietary Supplement|High NaCl + KHCO3|7.7 mmol Na/kgBW/d + 90 mmol KHCO3
16165997|NCT01655953|Other|Control: high NaCl|7.7 mmol Na/kgBW/d
16165998|NCT01655940|Device|Somanetics cerebral oximeter|Somanetics cerebral oximeter
16165999|NCT01655940|Device|CASMED cerebral oximeter|CASMED cerebral oximeter
16166000|NCT01655927|Drug|Tranexamic Acid|
16166001|NCT01655927|Drug|Placebo: Saline|
16166002|NCT01655914|Drug|Flumazenil|
16166003|NCT01655901|Behavioral|Active video gaming|
16166004|NCT01655901|Behavioral|Passive video gaming|
16166005|NCT01655901|Behavioral|Resting|
16166006|NCT01655888|Drug|Tremelimumab|Tremelimumab is administered as endovenous infusion
16166007|NCT01655875|Drug|AMD3100|AMD3100 will first be administered at 240 mcg/kg (the FDA approved dose for mobilization of autologous PBSC) IV once daily prior to conditioning for 3 days (days -6, -5 and -4) in the first group of participants. If toxicity criteria are met, the dosing will be escalated in the second group of participants to 240 mcg/kg IV once daily prior to conditioning for 5 days (days -8, -7, -6, -5 and -4).
16166008|NCT01655862|Biological|OnabotulinumtoxinA|OnabotulinumtoxinA injections at doses and frequencies as determined by the physician in accordance with clinical practice.
16166009|NCT01655849|Drug|z160|
16166010|NCT01655849|Drug|Placebo|
16166011|NCT01655836|Radiation|Brachytherapy|Undergo high dose rate brachytherapy
16166012|NCT01655836|Radiation|Stereotactic Body Radiation Therapy|Undergo stereotactic body radiation therapy
16166013|NCT01655836|Procedure|Quality-of-life assessment|Ancillary studies
16166014|NCT01655836|Other|Questionnaire administration|Ancillary studies
16166015|NCT01655823|Drug|Placebo|Sham treatment acting as control arm
16166016|NCT01655823|Drug|Tetrodotoxin|Comparison of different dosages of Tetrodotoxin
16166017|NCT01655810|Dietary Supplement|Vitamin D3|Multivitamin containing cholecalciferol 4000 units orally daily
16166018|NCT01655810|Dietary Supplement|Vitamin D3|Multivitamin containing cholecalciferol 600 units orally daily
16166019|NCT01655810|Dietary Supplement|Calcium carbonate|500 mg orally twice daily
16166020|NCT01655797|Behavioral|Cognitive behavior therapy for insomnia|Treatment comprised information about sleep and insomnia, methods for medication tapering, sleep hygiene, stimulus control, sleep restriction, progressive muscle relaxation, and dealing with sleep interfering thoughts.
16166021|NCT01655784|Procedure|Coil Embolization with larger Diameter Coils|Eighteen Coils placed in cerebral aneurysm
16166022|NCT01655784|Procedure|Coil Embolization with Standard Diameter Coils|Cerebral aneurysms will be embolized with standard diameter coils.
16166023|NCT01655771|Drug|TD-1211 Dose 1|
16166024|NCT01655771|Drug|TD-1211 Dose 2|
16166025|NCT01655758|Drug|0.5% timolol|
16166026|NCT01655758|Drug|timolol-dorzolamide fixed combination|
16166027|NCT01655758|Drug|Latanoprost|
16166028|NCT01655758|Drug|Travoprost|
16166029|NCT01655758|Drug|Bimatoprost|
16166030|NCT01655745|Procedure|FDG PET/MR|All patients will undergo a gadolinium enhanced MRI with simultaneous acquisition of FDG-PET prior to planned radical cystectomy and pelvic lymph node dissection
16307879|NCT00589420|Drug|sorafenib tosylate|
16166031|NCT01655732|Procedure|Atraumatic Restorative Treatment|ART is simple uninvasive technique involving removal of soft carious enamel and dentine by hand instrument only and then restore the cavity with adhesive restorative material.
16166032|NCT01655719|Drug|Pioglitazone|
16166033|NCT01655706|Drug|escitalopram|Patients will be given escitalopram for the first 8 weeks of the trial. At week 8, patients who are assessed as 'responders' will continue on escitalopram until study endpoint.
16166034|NCT01655706|Drug|aripiprazole|At Week 8, patients assessed as 'non-responders' will be given aripiprazole as an add-on treatment to escitalopram.
16166035|NCT01655693|Drug|Doxorubicin 20 mg/m2|
16166036|NCT01655693|Drug|Doxorubicin 30 mg/m2|
16166037|NCT01655693|Drug|Best Standard of Care|
16166038|NCT01655680|Drug|ABT-126|ABT-126 Middle Dose
16166039|NCT01655680|Drug|ABT-126|ABT-126 Low Dose
16166040|NCT01655680|Drug|ABT-126|ABT-126 High Dose
16166041|NCT01655680|Drug|Placebo|Placebo
16166042|NCT01655654|Behavioral|Physical activity|This intervention includes cardiorespiratory exercise, resistance exercise, flexibility exercise and neuromotor exercise.
16166043|NCT01655654|Behavioral|Dietary|Make at least one positive dietary change including or similar to a DASH diet snack substitution.
16166044|NCT01655654|Other|Primary care provider visit|Subjects with hypertension will be asked to visit their primary care provider seeking treatment options. If a subject does not have a primary care provider then they will be encouraged to obtain one and seek medical treatment.
16166045|NCT01655641|Drug|Tranexamic acid|"Drug: Tranexamic acid
~1gm stat, preoperatively (30 mins) 10mg / kg body weight, 8 hourly for 5 days via IV For non-renal impaired subjects.
~Alternate IV dosing for renally-impaired subjects: 10mg/Kg BID (1.36 - 2.83 mg/dl clearance); 10mg/Kg QD (2.84 - 5.66 mg/dl clearance; and 10mg/Kg Q48H or 5mg/Kg (.5.66mg/dl clearance)"
16166046|NCT01655641|Other|Standard of care|Includes routine surgical care involved in preventing blood loss during and after surgery.
16166047|NCT01655628|Drug|GC chemotherapy plus CIK cells (Gemcitabine, Cisplatin, Autologous CIK cells)|A total of 40 patients enrolled will be accept 4 cycles GC chemotherapy(every 4 weeks),then they will randomized divided into two groups. 20 patients will maintain autologous CIK cells for 8 cycles (every 4 weeks);the other 20 patients will not accept CIK cells treatment. Afer the all 40 patients have accomplished 4 cycles GC regimen chemotherapy plus CIK cells treatment or 4 cycles GC chemotherapy alone, the early effects will be assessed and long-term efficacy such as OS and PFS will be evaluated.
16166048|NCT01655628|Drug|GC chemotherapy (Gemcitabine, Cisplatin)|A total of 40 patients enrolled will be accept 4 cycles GC chemotherapy(every 4 weeks),then they will randomized divided into two groups. 20 patients will maintain autologous CIK cells for 8 cycles (every 4 weeks);the other 20 patients will not accept CIK cells treatment. Afer the all 40 patients have accomplished 4 cycles GC regimen chemotherapy plus CIK cells treatment or 4 cycles GC chemotherapy alone, the early effects will be assessed and long-term efficacy such as OS and PFS will be evaluated.
16166049|NCT01655615|Behavioral|Preventure programme|The interventions are conducted using manuals which incorporate psycho-educational, motivational enhancement therapy and cognitive-behavioural (CBT) components, and include real life 'scenarios' shared by local youth in with similar personality profiles. In the first session, participants are guided in a goal-setting exercise, designed to enhance motivation to change behaviour. Psycho-educational strategies are then used to teach participants about the target personality variable and associated problematic coping behaviours like avoidance, interpersonal dependence, aggression, risky behaviours and substance misuse.
16166050|NCT01655602|Procedure|Trichophytic closure upper edge trimming|'Trichophytic closure technique' can be done by trimming upper or lower wound edge for about 1 millimeter (as Fig.1) before wound closure. Then the linear scar will be less visible after hair growth. Anyway, there is no exactly wound edge (upper, lower or both) that recommended for the excellent cosmetic results without any severe side effects. Therefore, this study was designed to determine which is the best trichophytic closure technique.
16166051|NCT01655602|Procedure|Trichophytic closure lower edge trimming|'Trichophytic closure technique' can be done by trimming upper or lower wound edge for about 1 millimeter (as Fig.1) before wound closure. Then the linear scar will be less visible after hair growth. Anyway, there is no exactly wound edge (upper, lower or both) that recommended for the excellent cosmetic results without any severe side effects. Therefore, this study was designed to determine which is the best trichophytic closure technique.
16166052|NCT01655602|Procedure|Trichophytic closure both edge trimming|'Trichophytic closure technique' can be done by trimming upper and lower wound edge for about 0.5 millimeter (as Fig.1) before wound closure. Then the linear scar will be less visible after hair growth. Anyway, there is no exactly wound edge (upper, lower or both) that recommended for the excellent cosmetic results without any severe side effects. Therefore, this study was designed to determine which is the best trichophytic closure technique.
16166053|NCT01655576|Procedure|Placental drainage|After delivery of the newborn, umbilical cord at mothers end, will be left unclamped until delivery of the placenta.
16166054|NCT01655563|Drug|Tacrolimus|Tacrolimus, a calcineurin inhibitor, is the commonest immunosuppressive agent used for maintenance immunosuppression after solid organ transplantation. The mechanism of action involves binding to an intracellular protein, FKBP-12. A complex of tacrolimus-FKBP-12, calcium, calmodulin and calcineurin is then formed and the phosphatase activity of calcineurin is inhibited. This prevents the generation of nuclear factor of activated T-cells, a nuclear component, resulting in inhibition of transcription of lymphokines (interleukin-2, γ-interferon). The net result is the inhibition of T-lymphocyte activation.Tacrolimus is metabolized primarily by the CYP3A enzymes in the liver particularly the CYP3A5.
16166055|NCT01655550|Other|Withhold oral contrast|The intervention is to withhold oral contrast
16166056|NCT01655524|Drug|ASSUAGE Protocol|75 mg of aminophylline injected intravenously 90 seconds following the radioisotope injection in the setting of regadenoson nuclear stress test of the heart.
16166057|NCT01655511|Drug|Tafamidis|240 mg, solution, single dose
16166058|NCT01655511|Drug|Tafamidis|480 mg, solution, single dose
16166059|NCT01655511|Drug|Tafamidis|TBD dose will be a single dose if < 720 mg or a loading dose followed by additional dose if > 720 mg.
16166060|NCT01655498|Device|vaginal bowel control system (LivSure)|
16166061|NCT01655485|Other|Patient teaching|The Social script application is an story book on the iPAD with photos and script explaining the steps of getting a medical image such as a CAT scan from the perspective of the child.
16166062|NCT01655472|Device|imaging follow up: MRI scan|.1 Psychiatric interview. 2. Questionnaires 3. Blood samples for triple test: alfa feto protein, HCG, E3 4. A thorough fetal ultrasound examination including anatomic screening on 23-24 weeks of pregnancy. 5. A detailed trans-vaginal neurosonographic multi-planer examination, on 32-34 weeks of pregnancy 6. Fetal MRI scan on 32-34 weeks of pregnancy, 7. Newborn brain transfontanelar ultrasonography ,within 2 months postpartum 8. Newborn medical examination within 2 months postpartum.
16166063|NCT01655472|Device|imaging follow up: Ultrasonographic examination|
16166064|NCT01655459|Procedure|Ultrasound exam of upper airway|LMA-position was evaluated with fiberoptic laryngoscopy. The ultrasound findings of pre- and post-LMA were compared.
16166065|NCT01655446|Behavioral|Mirror Therapy|This protocol includes 1 hour mirror therapy and 0.5 hour functional training in a session. The treatment intensity is 1.5 hours/day, 5 days/week, for 4 weeks. MT focuses on symmetrical bimanual movements and simultaneously observing the mirror visual feedback reflected by the unaffected upper extremity.
16166066|NCT01655446|Behavioral|Conventional Rehabilitation|Participants in this group receive a structured protocol based on occupational therapy such as neuro-developmental techniques and task-oriented approach. The treatment dose is matched to RR and MT groups.
16166067|NCT01655446|Behavioral|Robotic Rehabilitation|This protocol includes 5 to 10 min of warm-up, 1 hr of RR, and 15 to 20 min of functional activities training. The treatment intensity is 1.5 hours/day, 5days/week for 4 consecutive weeks. The RR session uses the robot-assisted arm trainer, Bi-Manu-Track (Reha-Stim Co., Berlin, Germany).
16166068|NCT01655446|Behavioral|Robotic rehabilitation with FES|This combined RR-FES treatment involves the same protocol as the RR regimen except that patients receive FES concurrently with RR.
16166069|NCT01655446|Behavioral|Robotic Rehabilitation with PI|The RR-PI protocol is the same as the RR-FES protocol described above except that the surface electrodes are attached to the same target muscles on the affected UL but there is no output of electrical stimulation.
16166070|NCT01655433|Device|Velomedix APLS device|Velomedix, Automated Peritoneal Lavage System
16166071|NCT01655433|Other|No Hypothermia Treatment|
16166072|NCT01655420|Procedure|LASIK|Laser eye surgery
16166073|NCT01655407|Drug|Autologous Engineered Skin Substitute|"The total burn wound area covered will range from 288 cm^2 to 5,600 cm^2 (based on availability of matched-pair burn sites of similar area and depth) and this total grafting area will be divided equally for treatment with ESS-W and AG.
~ESS-W will be applied to the appropriate recipient site, according to the randomization schedule, by the surgeon using two pairs of forceps. Sufficient ESS-W sheets will be used to cover the recipient site. The ESS-W grafts will be stapled in place."
16166074|NCT01655407|Drug|Split-Thickness Autograft (AG)|"The total burn wound area covered will range from 288 cm^2 to 5,600 cm^2 (based on availability of matched-pair burn sites of similar area and depth) and this total grafting area will be divided equally for treatment with ESS-W and AG.
~The AG regimen occurs in stages, beginning with excision of the burned skin, followed by temporary wound coverage (e.g. cadaveric skin allografts, porcine xenograft, synthetic or biologic dressings or medical devices) to achieve wound homeostasis, and completed by permanent wound closure using autologous skin."
16166075|NCT01655381|Drug|Tocilizumab|Tocilizumab 8 mg/kg administered intravenously.
16166076|NCT01655368|Behavioral|psychotherapeutic STEM modules|psychoeducational and psychotherapeutical group intervention. 8 sessions of psychoeducation + 3 sessions + 1 booster session of STEM module for schizophrenia or depression)
16166077|NCT01655368|Behavioral|Interventional control of normal psychoeducational treatment|11 sessions + 1 booster session of psychoeducation (for schizophrenia or depression)
16166078|NCT01655316|Drug|Verapamil|
16166079|NCT01655303|Drug|Propranolol|
16166080|NCT01655303|Drug|Metoprolol|
16166081|NCT01655303|Drug|Verapamil|
16166082|NCT01655303|Drug|Diltiazem|
16166083|NCT01655290|Other|Gadovist® (Gadobutrol), Multihance® (Gadobenate dimeglumin)|Other (Diagnostic)
16166084|NCT01655277|Procedure|Ultrasound Guided Adductor Canal Block|
16166085|NCT01655277|Procedure|Ultrasound Guided Femoral Nerve Block|
16166086|NCT01655264|Behavioral|Home-based self training exercises for weak upper extremity|Each subject in the control group will receive twelve 45-60 min sessions (3 sessions per week for 4 weeks) while seated. They will receive self-training upper extremity exercises that are based on conventional therapy using principles of motor control and will include training of upper extremity movements in order to achieve better use of the affected arm in ADL. Each subject will receive a list of exercises to be performed in his home using a stand-alone poster as targets for the movements. In addition, each subject will be asked to write the dates and duration of time he/she did the each exercise. They will be in contact with a therapist once a week to monitor the self training program and adjust the level of exercise.
16166087|NCT01655264|Behavioral|Tele-rehabilitation exercises for weak upper extremity|The experimental group will receive tele-rehabilitation upper extremity exercises treatment of comparable duration and intensity to those in the home-based self training exercise treatment group. However, the treatment will be delivered via the Gertner Tele-Motion Rehabilitation system with remote online monitoring by the therapist. Treatment feedback will be given in the form of Knowledge of results (game scores) and Knowledge of performance (feedback of compensatory movements made while using the upper extremity) to enhance motor learning. The software will generate a report which will include the duration and type of exercises performed by the subject. If needed, a personal attendant may provide physical support in the tele home mock-up room.
16166088|NCT01655251|Behavioral|Intervention|
16166089|NCT01655238|Other|BMI|Screening guideline to assess body mass index.
16166090|NCT01655225|Drug|LY3023414|Administered orally. Dose of 20 to 600 mg, as determined in Part A.
16166091|NCT01655225|Drug|Midazolam|0.2 mg administered orally once before LY3023414 on Day 1 and once after LY3023414 on Day 15.
16166092|NCT01655225|Drug|Fulvestrant|500 mg administered IM on Day 1 and Day 15 in cycle 1 and Day 1 every 28 days for additional cycles.
16166093|NCT01655225|Drug|Pemetrexed|500 mg/m2 administered IV once on Day 1 every 21 days
16166094|NCT01655225|Drug|Cisplatin|75 mg/m2 administered IV once on Day 1 every 21 days
16166095|NCT01655225|Drug|Abemaciclib|Administered orally
16166096|NCT01655225|Drug|Letrozole|Administered orally
16166097|NCT01655212|Drug|Valganciclovir|Infants will be treated with valganciclovir for 6 weeks, 32 mg/kg daily dose in two doses, oral solution.
16166098|NCT01655199|Drug|Combination ipratropium/salbutamol or placebo (nebulization)|For the visit 2, COPD patients will be randomly assigned a combination of ipratropium/salbutamol or a placebo in a double-blind crossover design. For the visit 3, the other intervention drug will be assigned. The bronchodilation obtained with the medication will allow to determine if the 3-min step test is sensitive by detecting an improvement of exertional dyspnea following bronchodilation.
16166099|NCT01655186|Drug|Bardoxolone Methyl|
16166100|NCT01655186|Drug|Placebo|
16166101|NCT01655173|Behavioral|Cognitive behaviour therapy|"The CBT intervention consisted of five elements: (a) structure, (b) group setting, (c) psycho-education, (d) social training and (e) CBT.
~The participants were presented with the session plan for the whole year and given a binder in which they kept all materials. In addition, each session followed a strict agenda: (1) introduction and presentation of the agenda of the day, (2) resume of homework assignments from the previous session, (3) psycho-educative lecture and discussions on the session topic, (4) coffee break with buns or sandwiches, and social interaction, (5) relaxation or mindfulness exercise, (6) discussions and exercises on the session topic, (7) distribution of homework and (8) evaluation and end of session."
16166102|NCT01655173|Behavioral|Recreational activity intervention|The therapists did not provide any deliberate interventions, such as psychoeducation, social training or CBT. Instead, the intervention relied on structure and group setting only. During the first session the participants were asked to write down group activities they would like to engage in. The therapists created a list of the suggested activities, such as visiting museums, board game playing, cooking, restaurant visits, boating, cinema and taking walks. The participants voted for the activity of the next session.
16166103|NCT01655160|Behavioral|MT with low-intensity group (MT-LI)|The MT-LI group will receive a 30-minute MT per session followed by a 30-minute functional training.
16166104|NCT01655160|Behavioral|MT with moderate-intensity group|The MT-MI group will receive a 60-minute MT per session followed by a 30-minute functional training.
16166105|NCT01655160|Behavioral|Mirror therapy with high intensity group|The MT-HI group will receive a 90-minute MT per session followed by a 30-minute functional training
16166106|NCT01655160|Behavioral|Control intervention group|The CI group will carry out a 30-minute conventional stroke rehabilitation training per session followed by a 30-minute functional training.
16166107|NCT01655147|Drug|Abiraterone acetate|Type=exact number, unit=mg, number=1,000, form=tablet, route=oral. Abiraterone acetate administered on Day 1 of Period 1, and Day 14 of Period 2.
16166108|NCT01655147|Drug|Rifampicin|Type=exact number, unit=mg, number=600, form=capsule, route=oral. Rifampicin administered on Days 8 to 13 of Period 2.
16166109|NCT01655134|Other|Blood simples|
16166110|NCT01655134|Other|Capillary punction|
16166111|NCT01655134|Other|Urine simples|
16166112|NCT01655121|Dietary Supplement|High protein high fiber diet|"A personalized high protein high fiber dietary plan will be provided to each participant from both groups. Each participant will receive nutritional counseling once a month during six months.
~Each participant will receive nutritional counseling once month during six months."
16166113|NCT01655108|Drug|Minoxidil|Minoxidil 0.5% /2ml intradermal injection in the scalp ( mesotherapy), weekly sessions, ten weeks
16166114|NCT01655108|Drug|Saline|Physiological saline solution 0.9% , intradermal injection in the scalp ( mesotherapy), weekly sessions, ten weeks
16166115|NCT01655095|Drug|PEG|PEG 2L at 1800hrs the night before the test and 2L at 0500hrs the morning of the test.
16166116|NCT01655095|Drug|Prucalopride|Prucalopride 2mg will be administered at 0800hrs on the day of the test, at the same time the colon capsule is administered. Two hours later the position of the colon capsule will be assess with a Realtime Viewer. If the capsule has not reached the cecum a second dose of Prucalopride 2mg will be administered at that time.
16166117|NCT01655095|Drug|Picosalax|One sachet at 1800hrs the night before the test One sachet at 0500hrs the day of the test
16166118|NCT01655095|Drug|Bisacodyl|Bisacodyl 10mg in the evening three nights before the procedure and 10mg again two nights before the procedure.
16166119|NCT01655095|Procedure|Colon capsule|The colon capsule will be ingested at 0800hrs the day of the test. Seven hours will be allowed for the capsule to clear the bowel. The images will be reviewed by two endoscopists with experience reading video capsule endoscopy.
16166120|NCT01655095|Procedure|Colonoscopy|At 1500hrs on the day of the test all individuals will return to the endoscopy unit for a colonoscopy.
16166121|NCT01655082|Drug|V0116 transdermal patch|One patch per day (during 24 hours) for 21 days
16166122|NCT01655082|Drug|Nicotine transdermal patch|One patch per day (during 24 hours) for 21 days
16166123|NCT01655069|Drug|Solifenacin succinate suspension|Oral suspension
16166124|NCT01655056|Drug|YM150|oral
16166125|NCT01655056|Drug|Placebo|oral
16166126|NCT01655043|Drug|Regadenoson|Regadenoson will be infused intravenously 0.4 mg/5 mL (0.08 mg/mL) as a single bolus.
16166127|NCT01655043|Drug|gadofoveset trisodium|All subjects to receive 5 ml IV gadofoveset trisodium contrast (Ablavar) at both stress and rest.
16166128|NCT01655030|Dietary Supplement|creatine monohydrate|
16166129|NCT01655030|Dietary Supplement|placebo|
16166130|NCT01655017|Procedure|biopsy|adipose tissue biopsy (to evaluate inflammation and fibrosis)
16166131|NCT01655004|Drug|Exemestane|Exemestane is commercially available and will be obtained locally from the manufacturer. There are no experimental treatments in this study.
16166132|NCT01654991|Behavioral|Home Screening|Home-based STD screening using self-obtained urine samples and study paid postal return of samples.
16166133|NCT01654991|Behavioral|Clinic Screening|Clinic-based STD screening using self-obtained urine samples in a local university clinical setting.
16166134|NCT01654965|Other|Laboratory Biomarker Analysis|Correlative studies
16166135|NCT01654965|Biological|Pegfilgrastim|Given SC
16166136|NCT01654965|Other|Pharmacological Study|Correlative studies
16166137|NCT01654965|Drug|Tivantinib|Given PO
16166138|NCT01654965|Drug|Topotecan Hydrochloride|Given IV
16166139|NCT01654939|Drug|Rifaximin|All patients will be taking rifaximin 550 mg twice daily for one year for a diagnosis of hepatic encephalopathy
16166140|NCT01654926|Procedure|blood ultrafiltration|
16166185|NCT01654549|Drug|H.pylori eradication|Omeprazole (20 mg/BD)+ Amoxicillin (1 g/day)+ Bismuth subcitrate (240 mg/BD)+ Azithromycin (500 mg/BD)
16167057|NCT01648023|Device|LC or ONCOZENE Bead with Gem-Cis or Gem-Carbo|
16166141|NCT01654913|Device|hemoglobin measurement|"Non invasive hemoglobin measurements (Pronto 7 device and NBM-200 device)will be made with :
~at baseline (simultaneous blood sample for a laboratory measurement of hemoglobin),
~with the patient breathing oxygen via a face-mask (FiO2 50 ± 5%),
~with the patient breathing oxygen via a face-mask (FiO2 90 ± 5%) (simultaneous blood sample for a laboratory measurement of hemoglobin)."
16166142|NCT01654900|Other|No intervention in this study|
16166143|NCT01654887|Other|Lung Ultrasound|Six anatomic areas, delineated by the anterior, posterior, and mid- axillary lines will be systematically examined bilaterally, as per the modified Bedside Lung Ultrasound in Emergency (BLUE) protocol (Lichtenstein 2008). Ultrasound images will be obtained in longitudinal and transverse orientation, and recorded.
16166144|NCT01654887|Radiation|Chest X-Ray|Posterior-Anterior and lateral views of the chest via chest radiography followed by a lung ultrasound which is comprised of six anatomic areas, delineated by the anterior, posterior, and mid- axillary lines will be systematically examined bilaterally, as per the modified Bedside Lung Ultrasound in Emergency (BLUE) protocol (Lichtenstein 2008). Ultrasound images will be obtained in longitudinal and transverse orientation, and recorded.
16166145|NCT01654874|Drug|99mTc-MIP-1404|
16166146|NCT01654861|Drug|Gemcitabine, Intravenous and oral Ascorbic Acid (Vitamin C)|Weeks 1,2,3: IV Gemcitabine 1000 mg / m² over 30 minutes followed by HDIVC 1.2 g / kg: 1.2 g/kg over 90 minutes for a dose ≤90 g and over 120 minutes for a dose >90g followed by 0.3 g / kg over 120 minutes; Week 4: no treatment.
16166147|NCT01654835|Other|low blood pressure alert|"A Low Blood Pressure condition as specified (SAP <80 mmHg)will trigger an page to be sent to all anesthesia providers in <1 min that will read: A Low Blood Pressure condition has been detected. Consider hemodynamic support."
16166148|NCT01654835|Other|standard of care|A Low Blood Pressure condition as specified (SAP <80 mmHg)will be monitored by treatment team upon detection, but additional paged alert will not be generated.
16166149|NCT01654822|Drug|topical application cervical spray|one time (2 puffs) topical application of 100µl AV2-DM antiviral spray( containing 50% AV2-DM and 50% olive oil)on the cervix
16166150|NCT01654822|Drug|topical spray on the cervix|one time (2 puffs) topical spray of 100 µl (90% olive oil and 10% d-limonene) on the cervix
16166151|NCT01654822|Procedure|cervical swab with Cervex-Brush-Combi at T0|
16166152|NCT01654822|Procedure|cervical swab with Cervex-Brush-Combi at T1|
16166153|NCT01654822|Procedure|cervical swab with Cervex-Brush-Combi at T0|
16166154|NCT01654822|Procedure|cervical swab with Cervex-Brush-Combi at T1|
16166155|NCT01654809|Biological|evaluated vaccine|0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
16166156|NCT01654809|Biological|imported compared vaccine|0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
16166157|NCT01654809|Biological|domestic compared vaccine|0.25 mL, Intramuscular (infant/children dose) 0.5 mL, Intramuscular (adult dose)
16166158|NCT01654796|Device|Low Field Magnetic Stimulation (LFMS)|The LFMS devices produces a unique magnetic field that may help alleviate symptoms of depression.
16166159|NCT01654796|Device|Sham LFMS|Sham LFMS looks and sounds like the active treatment but does not produce any magnetic stimulation.
16166160|NCT01654770|Device|video capsule endoscopy|
16166161|NCT01654770|Device|double balloon enteroscopy|
16166162|NCT01654731|Drug|Bezafibrate|
16166163|NCT01654731|Drug|placebo|
16166164|NCT01654718|Drug|Pantoprazole|Pantoprazole 40mg Delayed release tablets (Test Product)
16166165|NCT01654718|Drug|Pantoprazole|Protonix® Delayed Release 40 mg tablets (Reference product)
16166166|NCT01654705|Drug|Pantoprazole|Pantoprazole 40mg Delayed release tablets (Test Product)
16166167|NCT01654705|Drug|Pantoprazole|Protonix® Delayed Release 40 mg tablets (Reference product)
16166168|NCT01654692|Drug|Ipilimumab and Fotemustine|Ipilimumab: 10 mg/kg q3 weeks for 4 doses, q12 weeks starting at Week 24 Fotemustine: 100 mg/m2 q1 week for 3 doses, q3 weeks starting at Week 9
16166169|NCT01654679|Device|wIRA irradiation|wIRA irradiation for 20min prior to surgery. The distance between the light bulb and the skin surface was 27cm.
16166170|NCT01654679|Other|visible light only|visible light application at a distance of 27cm from the skin surface with for 20 min.
16166171|NCT01654666|Procedure|Remote ischemic preconditioning|Remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 200 mmHg for 5-min followed by deflating the cuff for 5-min.
16166172|NCT01654666|Procedure|Sham remote ischemic preconditioning|Sham remote ischemic preconditioning consisted of five 5-min cycles of bilateral arm ischemia/reperfusion, which is induced by an automated cuff-inflator placed on bilateral arm and inflated to 60 mmHg for 5-min followed by deflating the cuff for 5-min.
16166173|NCT01654666|Procedure|Carotid Artery Stenting|Carotid Artery Stenting is an invasive therapy of carotid artery stenosis.
16166174|NCT01654653|Drug|Hypertonic sodium lactate|Administered at beginning of surgery as loading dose at 3 mL/kg body weight within 15 minutes. Additional fluid administered if needed and this was was managed similarly in both groups; the types and amount of additional fluid was measured and recorded. Surgery procedure and concomitant medication was managed similarly.
16166175|NCT01654653|Drug|6% Hydroxy Ethyl Starch|Administered at beginning of surgery as loading dose at 3 mL/kgBW within 15 minutes. Additional fluid given if needed and this was managed similarly in both groups; the types and amount of additional fluid was measured and recorded. Surgery procedure and concomitant medication was managed similarly
16166176|NCT01654640|Drug|Metformin|metformin 500mg p.o. bid for 24 weeks
16166177|NCT01654640|Drug|Placebo (for metformin)|placebo 1T bid
16166178|NCT01654627|Device|Regenecure AMCA GBR Dental Membrane|Patients will undergo Guided Bone Regeneration (GBR) procedure using the Regenecure AMCA GBR Membrane
16166179|NCT01654627|Device|Geistlich Bio-Gide® collagen membrane|The Geistlich Bio-Gide® collagen membrane, a commercially available product, will be used in 10 patients.
16166180|NCT01654601|Drug|DWCZP|Multiple dose
16166181|NCT01654601|Drug|Clozaril|multiple-dose
16166182|NCT01654575|Drug|Methotrexate|Methotrexate 25mg/week for 16 weeks
16166183|NCT01654575|Drug|Placebo|Placebo tablets once a week for 16 weeks
16166184|NCT01654562|Drug|Simvastatin|Simvastatin 40mg daily by mouth for 5 weeks (4-6 week window) followed by 5 week washout period (4-6 week window).
16166186|NCT01654536|Drug|ciclesonide nasal aerosol|ciclesonide nasal aerosol 74 mcg (given as 1 actuation per nostril of 37 mcg ciclesonide nasal aerosol)
16166187|NCT01654536|Drug|ciclesonide nasal spray|ciclesonide nasal spray 200 mcg (given as 2 actuations per nostril of 50 mcg ciclesonide nasal spray)
16166188|NCT01654523|Device|Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania|Awareness Enhancement and Monitoring Device for Treatment of Trichotillomania
16166189|NCT01654510|Behavioral|Cognitive Behavioral Therapy Group|This is a cognitive behavioral therapy group designed for homeless, unemployed people utelizing vocational rehabilitation services. The group is administered on a bi-weekly basis for four weeks, totalling eight sessions.
16166190|NCT01654510|Other|Vocational Services as Usual|
16166191|NCT01654497|Drug|Dexanabinol|"Dexanabinol: intravenous infusion over 3 hours, weekly (i.e., Day 1, 8, 15 and 22 of a 28-day cycle)
~Nine dosing cohorts are planned, with the option to enroll additional cohorts based on safety and PK data.
~Dose Level 1: 2 mg/kg
~Dose Level 2: 4 mg/kg
~Dose Level 3: 8 mg/kg
~Dose Level 4: 16 mg/kg
~Dose Level 5: 24 mg/kg
~Dose Level 6: 28 mg/kg
~Dose Level 7: 36 mg/kg
~Dose Level 8: 40 mg/kg
~Dose Level 9: 44 mg/kg"
16166192|NCT01654484|Drug|DE-117|Ophthalmic Solution, QD, 28 Days
16166193|NCT01654484|Drug|0.0015% tafluprost|Ophthalmic Solution, QD, 28 days
16166194|NCT01654484|Drug|DE-117 and 0.0015% tafluprost|Ophthalmic Solutions, QD, 28 days
16166195|NCT01654484|Drug|Placebo|Ophthalmic Solution, QD, 28 days
16166196|NCT01654458|Behavioral|GyneGals Support Group|12-week online (i.e. Internet-based), professionally-facilitated support group
16166197|NCT01654445|Drug|Tenecteplase|Tenecteplase will be given to the patient as an intravenous bolus over 1- 2 minutes within 90 minutes of the first slice of the CTA. This is an open-label trial, all patients will receive tenecteplase, either tier 1 or tier 2 dosage.
16166198|NCT01654432|Other|Paravertebral Blocks (PVB)|
16166199|NCT01654419|Device|Class II elastics and Sliding Jig|Class II elastics, 3/16 6 oz, used daily for 3 months 24 hours per day and sliding jig orthodontic device
16166200|NCT01654419|Device|Class II elastic alone|Elastics Class II alone, used 24 hours per day for 3 months from the hook of the upper canine to the first lower molar hook
16166201|NCT01654406|Device|Fractional CO2 laser and pulsed dye laser|Fractional CO2 laser: 50 mJ, 100 spots/cm2, a scan area of 4_4mm, static mode, and two passes Pulsed dye laser: 5mm,1.5ms,8J,delay cooling device 30/30,one pass
16166202|NCT01654406|Device|Pulsed dye laser|Pulsed dye laser: 5mm,1.5ms,8J,delay cooling device 30/30,one pass
16166203|NCT01654393|Other|Triage nurses applying the OAR|Triage nurses applying the OAR during assessment and ordering foot/ankle x-rays as necessary.
16166204|NCT01654380|Drug|LY2605541|LY2605541 is a solution. The concentration of LY2605541 is 100 units/milliliter (U/mL).
16166205|NCT01654380|Other|Insulin glargine|Insulin glargine is a 100 U/mL solution in 10 milliliter (mL) glass vial.
16166206|NCT01654367|Drug|Zoledronic Acid and Aromatase Inhibitors|Zoledronic Acid and Aromatase Inhibitors as Adjuvant Therapy
16166207|NCT01654354|Drug|NEOVIST 370 INJ.(Iopromide 768.86mg)|
16166208|NCT01654354|Drug|Ultravist 370 INJ.(Iopromide 768.86mg)|
16166209|NCT01654341|Behavioral|Exercise, dietary and educational program|
16166210|NCT01654328|Drug|Sodium chloride tablets|sodium chloride 1g/10kg of body weight /day per os on day -2 and -1 before contrast exposure. With a maximum dose of 10 gram sodium chloride a day.
16166211|NCT01654328|Drug|Isotonic saline intravenously|isotonic saline (Nacl 0.9%) total 1000ml in 4 hrs or (in case of heart failure or severe renal failure) 12 hrs before and in 4 or in 12 hrs after contrast administration.
16166212|NCT01654315|Device|Myomo Robotic Arm|"Patients are administered rehabilitative therapy (repetitive task specific therapy,, also known as RTP' in this study) using only the Myomo robotic device targeting their affected arms on 3 days/week during a 8 week period. These patients engage in RTP, which consists of a battery of activities that emphasize use of their affected arms repetitively, with the device providing assistance as needed with movement through the arm's range of motion."
16166213|NCT01654315|Behavioral|RTP Standard Therapy|Active Comparator: RTP Group Patients are administered rehabilitative therapy using only RTP that is targeting their affected arms on 3 days/week during a 8 week period. In this condition, patients engage in activities that emphasize use of their affected arms repetitively, with the therapist providing assistance as needed with movement through the arm's range of motion. As patients progress, the amount of assistance provided by the therapist during the activities is reduced.
16166214|NCT01654302|Drug|Synera|70 mg lidocaine/ 70 mg tetracaine topical patch applied once for 12 hours
16166215|NCT01654302|Drug|Inactive patch|placebo patch applied once for 12 hours
16166216|NCT01654289|Other|Mindfulness Meditation|"Training will consist of a standardized 8-week Mindfulness Based Stress Reduction (MBSR) program, including 2½ hour weekly sessions and regular at-home daily practice. Didactic sessions center on awareness of physical, emotional, cognitive, and interpersonal responses to stress. A half day meditation retreat on a weekend day at the end of week 6 will allow participants to practice their skills."
16166217|NCT01654289|Other|Exercise|Exercise training will primarily focus on walking or jogging, activities that are convenient, easy to teach and do not require special equipment. Individualized programs will be developed for those who have access to specific equipment, are unable to do walking/jogging, or prefer different types of exercise. Each weekly exercise session will include 1½ hours of didactic and 1 hour of group exercise. A half day exercise retreat designed to match the meditation retreat will occur the weekend of week 6. The retreat will include didactics, group discussion and activities, and individualized exercise practice.
16166218|NCT01654276|Drug|Febuxostat|One 40 mg tablet once a day for 6 months
16166219|NCT01654263|Biological|Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]|Prevnar 13 (PCV13) 13-valent pneumococcal conjugate vaccine. All doses given on Day 0. Group IA and IB (open-label): 0.5 mL intramuscular (IM) injection; Group IIA (open-label, randomized): 0.5 mL IM injection; Group IIB (open-label, randomized): 0.5 mL IM injection in the right arm and 0.5 mL IM in the left arm.
16166220|NCT01654250|Drug|NWP09|Methylphenidate, variable dose, daily dosing, 1 week duration
16166221|NCT01654250|Drug|Placebo|Placebo
16166222|NCT01654237|Other|questionnaires|185 industry workers divided in three sectors (factory, office and logistics) were assessed using the Nordic Musculoskeletal Questionnaire and lifestyle and work-related conditions questionnaires.
16166223|NCT01654224|Biological|High Dose Inactivated Influenza Vaccine|0.5 ml HDIV consisting of 180 mcg (60 mcg each strain) of influenza virus hemagglutinin
16166224|NCT01654224|Biological|Standard Dose Inactivated Influenza Vaccine|0.5 ml of standard dose inactivated influenza vaccine consisting of a total of 45 mcg (15 mcg each strain) of influenza virus hemagglutinin
16166225|NCT01654211|Drug|danoprevir|single iv infusion
16166226|NCT01654211|Drug|danoprevir|single oral dose
16166227|NCT01654211|Drug|placebo|single iv infusion
16166228|NCT01654211|Drug|ritonavir|oral doses
16166229|NCT01654198|Radiation|FDG-PET/CT scan|FDG-PET/CT is a type of imaging used currently to look for cancer. We are using it to look at inflammation within the joints.
16166230|NCT01654185|Drug|AI plus Dimethyldiguanide|AI 1 tablet per day Dimethyldiguanide 0.5 bid
16166231|NCT01654185|Drug|Aromatase Inhibitor|1 tablet per day
16166232|NCT01654172|Dietary Supplement|High Flavanol Cocoa|Total daily flavanol intake provided by the high flavanol drink is ~900mg
16166233|NCT01654172|Dietary Supplement|Low Flavanol Cocoa|
16166234|NCT01654159|Procedure|Monofocal IOL|Monofocal Intraocular lens will be implanted
16166235|NCT01654159|Procedure|Multifocal IOL|Multifocal IOL will be implanted
16166236|NCT01654159|Procedure|Toric IOL|Toric IOLS will be implanted
16166237|NCT01654146|Drug|Carboplatin|AUC5 by intravenous infusion over 30-60 minutes
16166238|NCT01654146|Drug|Carboplatin|AUC2 by intravenous infusion over 30-60 minutes
16166239|NCT01654146|Drug|Paclitaxel|175mg/m2 by intravenous infusion over 3 hours
16166240|NCT01654146|Drug|Paclitaxel|80mg/m2 by intravenous infusion over 1 hour
16166241|NCT01654133|Device|Endovascular repair of thoracoabdominal aortic aneurysm (TAAA) using branched stent graft|Repair of thoracoabdominal aortic aneurysms
16166242|NCT01654120|Drug|Liraglutide|SC, 1.8mg,QD, six months to one year
16166243|NCT01654120|Drug|Insulin|SC, will be titrated during the study, 4 times a day, 1 year
16166244|NCT01654107|Behavioral|Persistence Targeted Smoking Cessation|"8-weeks of smoking cessation counseling (Persistence Targeted Smoking Cessation)"
16166245|NCT01654107|Behavioral|Clearing The Air|8-weeks counseling + 12-weeks nicotine lozenge based on NCI protocol, Clearing The Air
16166246|NCT01654107|Drug|Nicotine lozenge|12-weeks 4mg nicotine lozenge
16166247|NCT01654094|Device|P6 Low Adherent Dressing|Each patient will have two similar, non-adjacent study sites. One site will be treated with P6 Low Adherent Dressing and the other site will be treated with the Standard of Care (SOC).
16166248|NCT01654094|Other|Standard of Care (SOC)|Each patient will have two similar, non-adjacent study sites. One site will be treated with P6 Low Adherent Dressing and the other site will be treated with the Standard of Care (SOC).
16166249|NCT01654081|Drug|Irinotecan|Irinotecan 125 mg/m2 on days 1, 8, 15 and 22 of every 6- week cycle
16166250|NCT01654068|Radiation|Conformal High Dose Intensity Modulated Radiation Therapy|Conformal High Dose Intensity Modulated Radiation Therapy 14-16Gy single fraction dosing using 6MV photons
16166251|NCT01654042|Other|Prolonged interval between PT testing|Patients in the intervention group will be scheduled for prothrombin time testing and dosing of warfarin every 12 weeks instead of every 4 weeks. This has been suggested in the latest edition of the ACCP guidelines as a possibility for very stable patients. In order to change this from a suggestion to a formal recommendation a study powered for clinically important outcomes is needed.
16166252|NCT01654029|Behavioral|Patient-Centred Communication Intervention|The intervention consists of three parts: 1) development of individualized communication care plans; 2) staff attendance at a workshop focused on communication and behavioral management strategies; and 3) implementation of a staff support system.
16166253|NCT01654016|Drug|Detralex|Detralex 500 mg twice daily for three month prior to surgery
16166254|NCT01654003|Other|CONTROL|In the CONTROL group, the administration of fluid (250-500ml crystalloids or colloids) and cardiovascular supportive drugs will be guided to maintain standard pressure-related parameters within a normal range: MAP > 65mmHg, HR < 90/min, CVP >8-12< cm H20, urinary output > 0.5 ml/kg/h. In line with the conventional approach, other physiological parameters will also be targeted: T° > 35.5°C, Sp02 > 95%, lactate < 2.5 mmol/L, normalisation of the BE. The maximal infused volume of hydroxyethyl starch (Voluven®) will be 33 ml/kg.
16166255|NCT01654003|Other|OPTIMIZED|In the OPTIMIZED group, the haemodynamic monitor (Pulsiocath)will help to a goal-directed administration of fluid (250-500ml crystalloids or colloids).The cardiovascular supportive drugs will be guided by an algorithm taking into account standard parameters (HR, MAP, lactate, Hb), as well as static and dynamic volumetric parameters (SVI, CI, GEDVI, EVLWI, SVV, PPV, PVI).
16166256|NCT01653990|Drug|moxifloxacin|oral dose of 400mg moxifloxacin
16166257|NCT01653990|Drug|moxifloxacin-placebo|Oral dose of a pill of moxifloxacin-placebo
16166258|NCT01653977|Other|CONTROL|In the CONTROL group, the administration of fluid (250-500ml crystalloids or colloids) and cardiovascular supportive drugs will be guided to maintain standard pressure-related parameters within a normal range: MAP > 65mmHg, HR < 90/min, CVP >8-12< cm H20, urinary output > 0.5 ml/kg/h. In line with the conventional approach, other physiological parameters will also be targeted: T° > 35.5°C, Sp02 > 95%, lactate < 2.5 mmol/L, normalisation of the BE. The maximal infused volume of hydroxyethyl starch (Voluven®) will be 33 ml/kg.
16166259|NCT01653977|Other|OPTIMIZED|"In the OPTIMIZED group, the central venous catheter and the 4-French artery catheter (femoral or humeral access site) will be connected to a dedicated haemodynamic monitor (Pulsiocath, PV2024L; Pulsion Medical Systems AG, Munich, Germany).
~The administration of fluid (250-500ml crystalloids or colloids) and cardiovascular supportive drugs will be guided by an algorithm taking into account standard parameters (HR, MAP, lactate, Hb), as well as static and dynamic volumetric parameters (SVI, CI, GEDVI, EVLWI, SVV, PPV, PVI)."
16166260|NCT01653964|Diagnostic Test|Molecular breast imaging|Molecular breast imaging performed with injection of Tc-99m sestamibi and a dedicated gamma camera (Luma Gem, Gamma Medica)
16166261|NCT01653951|Other|nurse-led care management or peer-led self management|
16166262|NCT01653938|Behavioral|video decision aid|
16166371|NCT01653223|Drug|simvastatin|"In short statin group: 20 mg per day, start at 5-7 days before surgery and continue for 7 days.
~In long statin group: 20 mg per day, start at 5-7 days before surgery and continue for 6 months."
16166372|NCT01653197|Behavioral|Control|No scratch off element
16166263|NCT01653925|Other|Dietary intervention first|The dietary intervention will be aimed to increase intake of ω-3 long chain fatty acids and to reduce intake of saturated and trans fatty acids. Three consultations with a nutritionist experienced in clinical trials will be planned over a 6-month period. An additional 2 consultations in the last 6 months with the study nutritionist will be planned for men allocated to the dietary fat intervention arm first. Then, after the 6 months of diet intervention, drug intervention with 5α-Reductase Inhibitor will be add to diet for the 6 following months.
16166264|NCT01653925|Drug|Drug (Dutasteride) intervention first|5α-Reductase Inhibitor will be taken daily in tablet dosage form (0.5 mg) taken orally for 12 months depend of the group. After 6 months of drug intake, dietary fat intervention will be add to treatment for the following 6 months. Three consultations with a nutritionist experienced in clinical trials will be planned over this 6-month period.
16166265|NCT01653912|Drug|GSK2110183 in combination with carboplatin and paclitaxel|Phase I is a dose escalation evaluation of increasing doses of GSK2110183 administered on a continuous daily schedule in combination with carboplatin AUC 5 and paclitaxel 175mg/m2 given every three weeks for a maximum 6 cycles. The dosing regimen identified in Phase I will then be evaluated in Phase II, a single arm study focused on clinical efficacy. Treatment with the three drug regimen will continue for a maximum of 6 x 21 day cycles followed by continuous GSK2110183 at the single agent MTD. Subjects may continue on study drug until progression, death or unacceptable toxicity.
16166266|NCT01653899|Drug|IDN-6556|14 day oral treatment of the investigational caspase inhibitor drug IDN-6556 following first islet transplant at 50mg twice daily.
16166267|NCT01653886|Other|Breakfast (1-2 hours, in the morning)|You will be required to taste small portions (1 to 2 bites) of 4 different breakfast meals. You will be asked to reate the taste after each meal. Meals will vary in fat and energy density, and will consist of two high fat diets and a high carbohydrate diet. Energy density is the ammount of enregy of kilocalories in one gram of the food.
16166268|NCT01653886|Other|Lunch (1-2 Hours, at midday)|You will be required to taste small portions of 4 different lunch meals. You will be asked to reate the taste after each meal. Meals will vary in fat and energy density, and will consist of two high fat diets and a high carbohydrate diet. Energy densityis the ammount of enregy of kilocalories in one gram of the food.
16166269|NCT01653886|Other|Dinner (1-2 hours, in the afternoon)|You will be required to taste small portions of 4 different dinner meals. You will be asked to reate the taste after each meal. Meals will vary in fat and energy density, and will consist of two high fat diets and a high carbohydrate diet. Energy densityis the ammount of enregy of kilocalories in one gram of the food.
16166270|NCT01653860|Behavioral|The Brøset anger management model|manualised structured cognitive treatment program 15 weeks (30 hours)
16166271|NCT01653860|Behavioral|Ordinary group treatment|group treatment 8 weeks (16 hours)
16166272|NCT01653847|Drug|Tacrolimus with MMF|Standard dose Tacrolimus and MMF. This will follow standard of care procedures at Northwestern Memorial Hospital's Comprehensive Transplant Center. MMF trough or area under the concentration time curve (AUC) shall not be used to adjust dosing. In this group, Tacrolimus will be initiated according to our practice. The Tacrolimus dose will be adjusted from day 3 on to achieve a target whole blood trough concentration of 8 ng/mL to 10 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be reduced to 6 ng/mL to 8 ng/mL. After month 6, the target level of Tacrolimus will be reduced to 4 ng/mL to 8 ng/mL.
16166273|NCT01653847|Drug|Group 2: Tacrolimus with Everolimus.|From day 5 on, the starting dose of Everolimus (0.75 mg bid) will be increased if the trough level is < 3 ng/mL, or reduced if the trough level is > 8 ng/mL. Tacrolimus will be initiated according to our practice. In this treatment arm, the Tacrolimus dose will be adjusted from day 3 on, to a target whole blood trough concentration of 4 ng/mL to 7 ng/mL. From month 2 until Month 6, the target Tacrolimus trough level will be 3 ng/mL to 6 ng/mL. After month 6, the Tacrolimus dose should be adjusted in order to achieve a target trough level of 2 ng/mL to 5 ng/mL. MMF dose will be initiated as 1 g b.i.d. (2 g/day). Adjustments should be made for adverse events including but not limited to gastrointestinal intolerance and a decrease in white blood cell (WBC).
16166274|NCT01653834|Procedure|Lymphocyte harvesting & reinfusion|Lymphocytes will be collected and stored approximately one week prior to initiating concurrent radiation therapy (RT) and temozolomide (TMZ). Two lymphocyte collections are allowed. After the patient has completed 6 weeks of RT/TMZ, all of the collected lymphocytes will be re-infused. After lymphocyte re-infusion, Heme-8 and absolute lymphocyte count (ALC) will be checked per standard of care. The absolute increase in ALC as the primary endpoint will be assessed 4 weeks after lymphocyte re-infusion.
16166275|NCT01653821|Procedure|Carotid body excision|
16166276|NCT01653808|Device|Elisio-210H|comparison of efficacy and biocompatibility of Elisio-210H dialyzer between conventional hemodialysis and on line hemodiafiltration
16166277|NCT01653808|Procedure|conventional hemodialysis|comparison of conventional hemodialysis with on line hemodiafiltration using Elisio-210H dialyzer
16166278|NCT01653808|Procedure|on line hemodiafiltration|comparison of on line hemodiafiltration with conventional hemodialysis using Elisio-210H dialyzer
16166279|NCT01653795|Device|LMA Unique: control device|LMA Unique will be placed in children based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, or 2.5. The size of the airway device will be determined according to the manufacturer's guidelines that are standardized by the patient's weight in kilograms.
16166280|NCT01653795|Device|LMA Supreme: comparison device|LMA Supreme will be placed in children based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, or 2.5, The size of the airway device will be determined according to the manufacturer's guidelines that are standardized by the patient's weight in kilograms.
16166281|NCT01653782|Behavioral|Kundalini yoga|Guided training twice a week for six weeks. Self instructing cd for home practice
16166282|NCT01653782|Behavioral|Self care advice|"Evidence based advice from caregiver about keeping active, exercise and a written self care pamphlet The Back book"
16166283|NCT01653782|Behavioral|Exercise|"Strength training at a gym supervised by a physical therapist twice a week during 6 weeks. Self training instruction was provided. A written self care pamphlet The Back book"
16166284|NCT01653756|Drug|IPI-145, a PI3K Inhibitor|Active drug
16166285|NCT01653756|Drug|Placebo to match IPI-145|Comparator
16166373|NCT01653197|Behavioral|Curiosity|The recipient will be prompted to scratch off for answer to question.
16166726|NCT01650558|Drug|Standard of Care prophylaxis|Daily trimethoprim sulfamethoxazole
16166286|NCT01653743|Drug|MSJ-0011|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol for maximum of 28 days will receive a single dose of 250 microgram (mcg) MSJ-0011 (choriogonadotropin alfa [recombinant human Chorionic Gonadotropin, r-hCG]) subcutaneously (SC) within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of greater than or equal to (>=) 18 millimeter (mm); not more than 3 follicles each with a mean diameter of >=16 mm and serum Estradiol (E2) level within an acceptable range for the number of follicle present, and not more than 2,000 picogram per milliliter (pg/mL).
16166287|NCT01653743|Drug|urinary hCG (u-hCG)|Subjects who underwent ovarian stimulation with follitropin alfa according to a low-dose step-up protocol for maximum of 28 days will receive a single dose of 5,000 IU u-hCG intramuscularly dose within 32 hours after the last dose of follitropin alfa administration unless dominant follicle reached a mean diameter of >=18 mm; not more than 3 follicles each with a mean diameter of >=16 mm and serum E2 level within an acceptable range for the number of follicle present, and not more than 2,000 pg/mL.
16166288|NCT01653743|Drug|Follitropin alpha|Low-dose step-up protocol involves starting dose of follitropin alfa as 75 International Units (IU) subcutaneously per day ,increments by 37.5 IU every 7 days (Day 8, 15, 28) will be done if no ovarian response will be observed for maximum of 28 days.
16166289|NCT01653730|Device|Eclipse 3 portable oxygen concentrator|
16166290|NCT01653730|Device|EverGo portable oxygen concentrator|
16166291|NCT01653730|Device|iGo portable oxygen concentrator|
16166292|NCT01653717|Procedure|Leukapheresis|Blood drawn through a needle in a vein in one arm, then passed though a machine to collect white blood cells, and then remaining blood returned back to patient through a needle in a vein in other arm. Procedure will take about 3 hours to complete.
16166293|NCT01653717|Drug|Fludarabine|25 mg/m2 by vein on Days -5 to Day -3.
16166294|NCT01653717|Drug|Cyclophosphamide|250 mg/kg by vein on Days -5 to -3.
16166295|NCT01653717|Procedure|T-cell Infusion|Beginning dose of genetically modified cells is > 5x10^7/m2 but less than or equal to 5 x10^8/m2 infused on Day 0.
16166296|NCT01653704|Behavioral|observational role|observational role in crisis scenario
16166297|NCT01653704|Behavioral|active role|active role in managing crisis scenario
16166298|NCT01653691|Procedure|Pulse-Dye Laser|Laser therapy will be applied to either one half or both halves of the subject's burn scar. Laser will be re-applied every 4-6 weeks for a total of 3 administrations.
16166299|NCT01653691|Procedure|Sham|No treatment to one side of subject's scar.
16166300|NCT01653678|Dietary Supplement|Vitamin D-3 (cholecalciferol), 2000 IU|
16166301|NCT01653678|Drug|Omega-3 fatty acids (fish oil)|Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA])
16166302|NCT01653678|Dietary Supplement|Vitamin D placebo|
16166303|NCT01653678|Drug|Fish oil placebo|
16166304|NCT01653665|Drug|Leukine|Daily subcutaneous injection of either 3 or 6 micrograms per kilo per day, for either 4 or 7 days.
16166305|NCT01653665|Drug|Normal Saline|Patients in the randomised controlled trial may receive this placebo as a single daily subcutaneous injection. The volume will match that of the active drug.
16166306|NCT01653652|Dietary Supplement|Probiotic|
16166307|NCT01653652|Dietary Supplement|Maltodextrin|
16166308|NCT01653639|Biological|Recombinant Factor VIII (Kogenate FS, BAY14-2222)|50 IU/kg single dose using the 3000 IU vial size (600 IU/ml)
16166309|NCT01653639|Biological|Recombinant Factor VIII (Kogenate FS, BAY14-2222)|50 IU/kg single dose using the 2000 IU vial size (400 IU/ml)
16166310|NCT01653626|Other|package of 3 interventions|Emergency Obstetric Care training, social marketing approach and link TBS with public sector services
16166311|NCT01653613|Genetic|DNA analysis|
16166312|NCT01653613|Genetic|fluorescence in situ hybridization|
16166313|NCT01653613|Genetic|gene expression analysis|
16166314|NCT01653613|Genetic|microarray analysis|
16166315|NCT01653613|Genetic|mutation analysis|
16166316|NCT01653613|Genetic|polymorphism analysis|
16166317|NCT01653613|Genetic|reverse transcriptase-polymerase chain reaction|
16166318|NCT01653613|Other|laboratory biomarker analysis|
16166319|NCT01653600|Device|S.M.A.R.T CONTROL Stent|Provisional stenting should be performed; the case that optimal ballooning response is not obtained (sub-optimal balloon response) should be enrolled. The procedure is usually done, as follows; After the guidewire is passed through the target lesion, predilation of the target lesion with an optimally sized balloon will be performed prior to stent implantation. Recommended, minimal balloon dilation time is 120 seconds. The sub-optimal balloon response is defined as a residual pressure gradient of >15 mmHg, residual stenosis of >30%, and flow-limiting dissection.
16166320|NCT01653600|Device|LifeStent|same to SMART STENT
16166321|NCT01653587|Device|Percutaneous coronary intervention|Both transradial and transfemoral coronary angiography will be performed by the Judkins technique using arterial introducers with 6 French diameter and pre-molded catheters for selective catheterization of left and right coronary arteries.Percutaneous coronary intervention will be indicated when a culprit lesion is identified, with stenosis diameter severity ≥ 70%, with high probability of angiographic success, being ideally performed immediately after coronary angiography and left ventriculography. Patients with multiarterial coronary disease will be submitted to percutaneous coronary intervention after agreement among cardiologist, interventional cardiologist and thoracic surgeon. Procedures will be performed according to recommendations and provisions of current guidelines.
16166322|NCT01653574|Drug|Famitinib Malate|The starting dose of Famitinib Malate will be 25 mg/d. Two dose reductions will be allowed to 20 and then 15 mg/d.
16166323|NCT01653561|Drug|Apatinib|The starting dose of apatinib will be 500mg/d. Two dose reductions will be allowed to 375 and then 250 mg/d.
16166324|NCT01653548|Behavioral|Habituation Reminder Training|Participants will hear a unique sound after habituating to a personal stressor.
16166325|NCT01653548|Behavioral|Habituation Reminder|Participants will hear the habituation reminder outside of the lab via a cellular phone.
16166326|NCT01653548|Behavioral|Habituation|Participants will habituate to personally-relevant stressor.
16166374|NCT01653197|Behavioral|Curiosity linked to Action|The recipient will be prompted to scratch off for answer only after he/she makes an appointment.
16314590|NCT00539929|Drug|E6201 0.01%|
16166327|NCT01653535|Behavioral|Fast Track|First grade intervention included a weekly two-hour curriculum-based day that was attended by high-risk children, parents, program staff, and teachers of the high-risk children. During each session, the staff modeled academic tutoring with target children in the presence of their parents. In 3rd and 4th grades, intervention consisted of monthly parent and child curriculum-based sessions during the academic year, home visiting, and teachers implementing the in-class PATHS prevention program. In 5th and 6th grades, intervention included monthly parent and child groups and home visiting. In grades 8, 9 and 10 staff developed sessions on an as needed basis to cover topics like transition to high school, note-taking, and study skills.
16166328|NCT01653522|Drug|Triptan|
16166329|NCT01653522|Drug|Doxycycline|
16166330|NCT01653509|Device|Acyclovir patch|Patch containing acyclovir
16166331|NCT01653509|Device|Placebo patch|Patch without acyclovir
16166332|NCT01653496|Procedure|Enhanced recovery after surgery|The main 18 elements of ERAS program included are described in detail in the brief summary of the study
16166333|NCT01653483|Drug|GSK573719|Novel Dry-Powder Inhaler
16166334|NCT01653483|Drug|GSK573719matched-placebo|Novel Dry-Powder Inhaler
16166335|NCT01653470|Drug|Paclitaxel|
16166336|NCT01653470|Drug|5-Fluorouracil (5FU)|
16166337|NCT01653470|Drug|Carboplatin|
16166338|NCT01653470|Drug|Leucovorin|
16166339|NCT01653470|Drug|Irinotecan|
16166340|NCT01653470|Drug|Paclitaxel|
16166341|NCT01653470|Drug|BMS-906024|
16166342|NCT01653457|Drug|Memantine|"Patients randomised to this arm will receive memantine 20 mg daily. This dose will be reached following this schema:
~1st week: 5 mg daily
~2nd week: 10 mg daily
~3rd week: 15 mg daily
~From 4th week up to 24th week: 20 mg daily"
16166343|NCT01653457|Drug|Placebo|Patients randomised to this group will receive film-coated placebo tablets (similar to drug tablets.
16166344|NCT01653444|Drug|GC1119|biweekly, IV infusion
16166345|NCT01653431|Device|Transcranial direct current stimulation|
16166346|NCT01653418|Drug|Bortezomib|
16166347|NCT01653418|Drug|Carmustine|
16166348|NCT01653418|Drug|Etoposide|
16166349|NCT01653418|Drug|Cytarabine|
16166350|NCT01653418|Drug|Melphalan|
16166351|NCT01653418|Procedure|Stem cell infusion|
16166352|NCT01653405|Other|Multifaceted behavioral intervention|The intervention included access to a system to measure processes of care relevant to warfarin management, along with targeted audit and feedback.
16166353|NCT01653392|Biological|Observational Intervention|This is an observational study, therefore no interventions are specified.
16166354|NCT01653379|Drug|DP001|DP001 softgel capsules; 55 ng to 550 ng per dose, administered 3 times weekly for 4 weeks
16166355|NCT01653366|Behavioral|Physical Activity Goal Setting|"Will include an initial physical therapy (PTA) consult to set exercise goals to increase physical activity by 6000 steps per week over the course of the trial, viewing of the Exercise and Breast Cancer digital video disc (DVD, followed by 10 regular phone calls or RN visits (weekly for the first month, then monthly) to follow up on whether or not those goals are being met and, if not, how best to meet them."
16166356|NCT01653353|Behavioral|peer physician-applied recommendation to the physicians|The peer physician-applied recommendation will include scientific information, practical recommendations to correctly supplement with calcium and vitamin D and a list of individual appraisals of the prescribed supplements among the residents.
16166357|NCT01653340|Device|Senza™, High Frequency Spinal Cord Stimulator for Refractory Chronic Migraine|http://nevro.com/corporate/system-us
16166358|NCT01653327|Drug|Ketamine|Twenty milligrams of ketamine will be dissolved in 4 mL of pharmaceutical cherry syrup and 1 ml of normal saline.
16166359|NCT01653327|Drug|Placebo|
16166360|NCT01653314|Drug|Megavec|
16166361|NCT01653314|Drug|Glivec|
16166362|NCT01653301|Drug|XELAC RT|"Xeloda 1650mg/m2 chronomodulated (h 8.00 a.m. 25% of total dose ; h 6.00 p.m. 25% of total dose; h 11.00 p.m. 50% of total dose) during the whole treatment time.
~RT: pelvic treatment is the same for both arms: 45 Gy are delivered to the whole pelvis at 1.8 Gy daily, 5 times per week.
~In the XEL-ACRT arm a boost of 10 Gy is delivered to the mesorectum corresponding to the GTV, at 1 Gy for fraction to a total dose of 55 Gy, in 10 fractions over 5 weeks, 2 times a week. The daily dose of the boost will be delivered twice a week immediately after the daily dose administered to the pelvis (concomitant boost)."
16166363|NCT01653301|Drug|XELOX RT|"Xeloda: 1300 mg/m2 chronomodulated (h 8.00 a.m. 25% of total dose ; h 6.00 p.m. 25% of total dose; h 11.00 p.m. 50% of total dose), during the whole treatment time;
~Oxaliplatin: 130mg/m2, days 1, 19, 38
~RT: pelvic treatment is the same for both arms: 45 Gy are delivered to the whole pelvis at 1.8 Gy daily, 5 times per week; In the XELOX-RT arm a boost of 5.4 Gy is delivered to the mesorectum corresponding to GTV, at 1.8 Gy daily, in 3 fractions, to a total dose of 50.4 Gy. The boost will be delivered at the end of the irradiation of the pelvis (sequential boost)."
16166364|NCT01653288|Behavioral|Coping Coach|Coping Coach is a self-guided web-based intervention that utilizes an interactive, developmentally appropriate, game-like format, to provide practical information and teach children adaptive coping strategies. Children are primary users of the intervention, with parent supervision. Modules (20-30 minutes each) can be repeated to solidify skills / learning. The feelings module targets recognition of emotions after potentially traumatic experiences. The appraisals module targets the connection of helpful or unhelpful thoughts to feelings and behavior. The avoidance module targets reducing reliance on avoidance as a (maladaptive) coping response. Promoting social support is folded throughout the intervention. Information will be provided to parents about how to access additional resources and when to get additional professional help.
16166365|NCT01653275|Other|Mediterranean Diet|Subjects will receive key foods (olive oil, walnuts, frozen portions of high n-3 LCPUFA fish) and instructed in the quantity to consume each week. Olive oil : minimum of 3 tablespoons per day. Walnuts:10.5 oz/week (1.5 oz/day). High n-3 LCPUFA fish: 3 or more fish meals per week. Additional guidelines for altering diet include incorporation of fruits, vegetables, legumes, and whole grains to replace sweets, white bread and starches, red meat and highly processed foods.
16166366|NCT01653262|Drug|Brivaracetam|
16166367|NCT01653249|Biological|Vaccine consisting of four HPV-16 E6 peptides in combination with Candin®|
16166368|NCT01653236|Drug|Boceprevir|
16166369|NCT01653236|Drug|Peginterferon alfa-2b|
16166370|NCT01653236|Drug|ribavirin|
16314591|NCT00539929|Drug|E6201 0.03%|
16166375|NCT01653184|Dietary Supplement|Omega-3 fatty acid|The purpose of our study is to evaluate the change in serum omega-3 index (blood level of omega-3 fatty acids) after 1 gram of omega-3 fatty acid supplementation versus 2 grams.
16166376|NCT01653171|Drug|Water (Placebo)|Water 100 mL
16166377|NCT01653171|Drug|Simethicone|200 mg (5 mL) in water for up to 100 mL, to take 20 minutes prior to examination
16166378|NCT01653171|Drug|N-acetylcysteine 500 mg|500 mg + Simethicone 200 mg in water for up to 100 mL, to take 20 minutes prior to examination
16166379|NCT01653171|Drug|N-acetylcysteine 1000 mg|1000 mg + Simethicone 200 mg in water for up to 100 mL, to take 20 minutes prior to examination
16166380|NCT01653158|Drug|CP-751,871|"CP-751,871 was given intravenously [IV] every 3 weeks in escalating doses ranging from 0.1 mg/kg up to 20 mg/kg.
~Standard doses of Docetaxel were given every 3 weeks with CP-751,871. Study therapy was continued until disease progression, lack of tolerability for up to 17 cycles (approximately 1 year)."
16166381|NCT01653158|Drug|Docetaxel|Docetaxel up to 75 mg/m^2 was administered intravenously [IV] on Day 1 of each 3-week dosing cycle.
16166382|NCT01653145|Other|Diet A|Dietary
16166383|NCT01653145|Other|Diet B|Dietary
16166384|NCT01653145|Other|Diet C|Dietary
16166385|NCT01653132|Drug|Incobotulinum Toxin A|Twenty units (0.2 ml) of incobotulinum toxin A were injected into each parotid gland and 30 units (0.3 ml) to each submandibular gland for a total dose of 100 units using anatomical landmarks
16166386|NCT01653132|Drug|Placebo|Sterile, preservative free 0.9% saline, 1 ml, was used as placebo, and injected into the parotid (0.2 ml each) and submandibular (0.3ml each) glands .
16166387|NCT01653119|Drug|Rosuvastatin|Both of the two groups will be given standard ACS treatment according to treatment guidelines during the following 1 year.
16166388|NCT01653106|Procedure|cryotherapy|Receive shaved ice
16166389|NCT01653106|Other|questionnaire administration|Participate in PROMS
16166390|NCT01653106|Other|pharmacological study|Correlative studies
16166391|NCT01653093|Procedure|3-Tesla magnetic resonance imaging (3T MRI)|Undergo 3T MRI
16166392|NCT01653093|Procedure|diffusion-weighted magnetic resonance imaging|Undergo diffusion-weighted MRI
16166393|NCT01653093|Procedure|dynamic contrast-enhanced magnetic resonance imaging|Undergo DCE-MRI
16166394|NCT01653093|Procedure|magnetic resonance spectroscopic imaging|Undergo MR spectroscopy
16166395|NCT01653080|Procedure|dynamic contrast-enhanced MRI|Studies will be performed on standard clinical MR Systems which are available on Campus. With the proposed imaging technique, we are able to acquire a 3D volume covering the orbit with a temporal resolution of approximately 15s. The affected eye will be immobilized to reduce motion artifacts. A routinely used MR contrast agent will be administered in a dose of 0.1mmol/kg bodyweight.
16166396|NCT01653067|Drug|Rituximab, Temsirolimus, DHAP, intravenous|Maximum tolerated dose of Temsirolimus Rituximab (375 mg/m²) Dexamethasone (120 mg) Cisplatin (100mg/m²) Cytarabine (2x2g/m²))
16166397|NCT01653054|Procedure|Anal Pap Smear, HPV DNA Testing|Anal Pap Smears and HPV DNA testing will be performed on all subjects.
16166398|NCT01653041|Drug|Everolimus|
16166399|NCT01653028|Drug|Alisertib|Given PO
16166400|NCT01653028|Other|Laboratory Biomarker Analysis|Correlative studies
16166401|NCT01653015|Biological|Trivalent Inactivated Vaccine|Influenza vaccination, 0.5 ml dose administered intramuscularly. Previously unvaccinated children who are less than 9 years of age at the time of immunization will receive a second 0.5 ml dose four weeks later.
16166402|NCT01653015|Biological|Live Attenuated Influenza Vaccine|Influenza vaccination, 0.2 ml dose administered intranasally. Previously unvaccinated children who are less than 9 years of age at the time of immunization will receive a second 0.2 ml dose of the vaccine four weeks later.
16166403|NCT01653002|Other|No intervention|
16166404|NCT01652989|Behavioral|Weight loss maintenance intervention face-to-face|
16166405|NCT01652989|Behavioral|Weight loss maintenance intervention delivered via DVD|
16166406|NCT01652976|Drug|Dasatinib|Dasatinib 150mg PO daily on days 1-14 of each 14 day cycle
16166407|NCT01652976|Drug|mFOLFOX6|mFOLFOX6 (oxaliplatin 85mg/m2 IV, leucovorin 400mg/m2 IV, 5-Fluorouracil bolus 400mg/m2 IV, and 5-Fluorouracil 2400mg/m2 IV) on day 1 of each 14 day cycle
16166408|NCT01652963|Other|Reed and Clements Training Task|see study arm: Reed and Clements Training Task. Training task developed to improve cognitive mediation skills in people with intellectual disabilities.
16166409|NCT01652950|Behavioral|Financial incentives|"The incentive arms comprised a Direct Payment Group, a Charity Incentive Group, a Lottery Pay-out Group, and a Choice Group. Members were offered the base program and supplementary communication described above. In addition, individuals were offered the equivalent of one of four possible incentive amounts depending on the level of participation in fitness-related activities. Enrollment into the trial took place for a period of 5 months, and the intervention took place over a period of 12 months following registration.
~Level 1: <150 fitness points per month - equivalent to < 1 gym visit per month - no reward, up to Level 5, which was >3000 fitness points/month - equivalent to >20 gym visits/month."
16166410|NCT01652937|Drug|BIIB057|Oral
16166411|NCT01652937|Drug|Placebo|Oral
16166412|NCT01652924|Device|Mechanical ventilation with facial mask|This group includes patients with the randomization process are assigned to mechanical ventilation with facial mask during induction of anesthesia, which will be maintained until to secure airway with endotracheal tube to determine the presence of gastric insufflation. The size of the facial mask is used according to the age and ventilation parameters are: inspiratory pressure 10 cmH2O, PEEP 5 cmH2O, respiratory frequency and relation I/E according to age .
16166413|NCT01652924|Device|Manual ventilation with facial mask|"This group includes patients with the randomization process are allocated to manual ventilation with facial mask during induction of anesthesia, which will be maintained until to secure airway with endotracheal tube to determine the presence of gastric insufflation.
~The size of the facial mask is used according to the age and ventilator y parameters are selected by the anesthesiologist."
16166414|NCT01652911|Device|Sernova Cell Pouch|The Cell Pouch™ is an implantable medical device for transplantation of donor islets for Type-1 diabetes as an alternative to the current standard of care using intraportal delivery of islets.
16166415|NCT01652898|Drug|LDLA202|Comparison of 3 different doses LDLA202, 40 PK samples, 40 BP and ECG measurement time points, 23 local tolerability measurement time points
16314592|NCT00539929|Drug|Placebo|
16166416|NCT01652898|Drug|ONO LDL50|Comparison of 3 different doses ONO LDL50, 40 PK samples, 40 BP and ECG measurement time points, 23 local tolerability measurement time points
16166417|NCT01652898|Drug|Esmolol hydrochloride|Comparison of 3 different doses Esmolol, 40 PK samples, 40 BP and ECG measurement time points, 23 local tolerability measurement time points
16166418|NCT01652885|Drug|AN2728 Topical Ointment, 2%|AN2728 Topical Ointment, 2%
16166419|NCT01652872|Biological|Darbepoetin alfa|Darbepoetin alfa was presented as single use prefilled syringes (PFS). Investigational product was administered SC Q4W for the duration of the treatment period.
16166420|NCT01652872|Other|Placebo|Placebo was presented as single use PFS. Participants received a SC placebo injection in place of darbepoetin alfa therapy when the dose of study drug was withheld per the dosing algorithm for the duration of the treatment period.
16166421|NCT01652859|Drug|Liposomal Amphotericin B|
16166422|NCT01652859|Drug|AmBisome|
16166423|NCT01652833|Other|Physician Survey|Eligible physicians will be contacted via telephone to perform the physician survey. A standardised questionnaire will be used to collect information about the physician's awareness of the correct indication and appropriate administration of Vectibix and the physician's experience in the administration of Vectibix treatment in the previous 6 months
16166424|NCT01652820|Drug|Docetaxel 20mg/m2/week + carboplatin AUC 2/weekly - concomitant chemoradiation 2Gy/day|
16166425|NCT01652820|Drug|Docetaxel 40mg<7m2 d1,8, 21, 28+ gemcitabine 1200mg/m2 d1,8, 21, 28 + concomitant docetaxel 20mg/m2/w+carboplatin AUC 2/w+ concomitant RDT 2Gy/d|
16166426|NCT01652807|Behavioral|Hatha Yoga|The yoga intervention will last eight weeks and include two 90-minute sessions each week. Each yoga session will consist of the same series of 26 Hatha yoga postures, two breathing exercise, and two savasanas (i.e., a resting/relaxation posture), in a room heated to 104 degrees Fahrenheit, which aids in safe muscle stretching. Each participant will be given a yoga studio scan card valid for two months, and, like all yoga studio members, they will be required to scan their card prior to their yoga class.
16166427|NCT01652794|Radiation|stereotactic body radiation therapy|Undergo SBRT
16166428|NCT01652794|Drug|carboplatin|Given IV
16166429|NCT01652794|Drug|gemcitabine hydrochloride|Given IV
16166430|NCT01652794|Other|laboratory biomarker analysis|Optional correlative studies
16166431|NCT01652794|Other|pharmacogenomic studies|Optional correlative studies
16166432|NCT01652781|Drug|Azacitidine|5-day arm: azacitidine 75mg/m2 subcutaneously for 7 days every 28 days + best supportive care 7-day arm: azacitidine 75mg/m2 subcutaneously for 5 days every 28 days + best supportive care
16166433|NCT01652768|Other|Research Questionnaires|Hospital Anxiety and Depression Scale Pearlin & Schooler Caregiver Mastery Caregiver Assessment Tool Patient/Caregiver Satisfaction Survey
16166434|NCT01652768|Other|Palliative Care Team|"Week 1: Early palliative care intervention (immediately post-op) provided by the new palliative care brain tumor team (Social worker, advanced practice nurse (APN), medical oncology registered nurse).
~Introduce the palliative care team concept.
~Provide contact information for the palliative care team given
~Administer Initial Patient and Caregiver Psychosocial Assessments (Appendix A)
~Offer community resources to patient and caregiver (Appendix B)
~Provide additional resources/referrals for any needs that are identified by patient or care partner during initial psychosocial assessment
~Provide supportive care"
16166435|NCT01652768|Other|Educational Information Session for Patients and Caregivers|"Provide an educational class Moving Forward: Facing a Brain Tumor Diagnosis for patient and caregiver Week 5 through 7: The PRESENCE Project Social Worker and oncology RN will provide an educational class.
~Intervention (Length of time for class = 2 hours):
~Provide an educational class Moving Forward: Facing a Brain Tumor Diagnosis for patient and caregiver.
~Provide additional resources/referrals for any needs that are identified by patient or care partner during the educational class.
~Provide supportive care."
16166436|NCT01652768|Other|Contact every 2 weeks|"The PRESENCE Project APN and/or Presence Project Social Worker will contact the patient and caregiver via telephone or office visit every two weeks and as needed until the second medical oncology visit.
~(Anticipated length of time for phone intervention or visit is 20 minutes; however, length of time for intervention is tailored to the patient and caregiver's needs):
~Administer Patient and Caregiver Follow-up Assessment
~Provide pain and/or symptom management intervention for any issues identified during the follow-up assessment
~Provide resources/referrals for any needs identified during the social work follow-up assessment
~Provide supportive care"
16166437|NCT01652768|Other|Follow-up Surgical Visit Session|"The PRESENCE Project APN will meet with patient and caregiver at the surgical follow-up visit, approximately two weeks after surgery.
~Intervention (Anticipated length of time for visit is about 30 minutes; however length of time for intervention is tailored to the patient and caregiver's needs):
~Administer Patient and Caregiver Follow-up Assessment
~Administer Symptom Assessment Tool
~Provide pain and/or symptom management intervention
~Provide supportive care"
16166438|NCT01652768|Other|Medical and/or Radiation Oncology Appointment Session|"The PRESENCE Project APN and/or Presence Project Social Worker will meet with patient and caregiver at the first medical and/or radiation oncology appointment (weeks 3 and 4).
~Intervention (Anticipated length of time for visit is about 30 minutes; however length of time for intervention is tailored to the patient and caregiver's needs):
~Administer Patient and Caregiver Follow-up Assessment
~Re-assess pain and/or symptom management issues and /or intervention
~Provide resources/referrals for any needs identified during the social work follow-up assessment
~Provide supportive care."
16166439|NCT01652742|Drug|BI 135585 XX|one single dose
16166440|NCT01652729|Drug|Exenatide once weekly suspension|
16166441|NCT01652729|Drug|Sitagliptin|
16166442|NCT01652729|Drug|Placebo|Placebo oral capsule once daily
16166443|NCT01652716|Drug|Exenatide once weekly suspension|Exenatide suspension 2 mg weekly subcutaneous injection
16166444|NCT01652716|Drug|Exenatide twice daily|5 mcg twice daily for 4 weeks followed by 10 mcg twice daily for 24 weeks
16166445|NCT01652703|Biological|Evolocumab|Administered by subcutaneous injection
16166446|NCT01652703|Other|Placebo|Administered by subcutaneous injection
16166447|NCT01652690|Biological|Denosumab|This is an non-interventional study, therefore denosumab is administered as part of routine care and not for purposes of the study.
16166448|NCT01652677|Procedure|Transcranial magnetic stimulation|Transcranial magnetic stimulation is a noninvasive technique for including electrical currents in the cerebral cortex by means of time-varying magnetic fields.
16166450|NCT01652664|Drug|Timolol, 0.5% or 0.25% ophthalmic solution|Patients 2 months to < 3 years of age received 0.25%
16166451|NCT01652664|Drug|Travoprost Vehicle|Inactive ingredients used to maintain masking
16166452|NCT01652651|Behavioral|I Can Succeed ICS|ICS is a manual-based psychological intervention aimed to address both emotional and academic-executive functions aspects of LD.It consists of acute phase (13 once a week sessions) and follow-up phase (6 sessions over 18 months). ICS focuses on developing intrapersonal skills (e.g. self awareness, goal setting, organizational skills), interpersonal skills (e.g. communication, problem solving)and school/community skills (i.e. strengthening the family-school relationship) (Kopelman-Rubin et al., 2011).
16166453|NCT01652638|Drug|Heparin|Whereas it will be a crossover study with two periods, each drug will be administered only once, at a dose of 5.000UI. In each period, the drug will be administered subcutaneously.
16166454|NCT01652625|Drug|Yunnan Baiyao toothpaste|The patients were instructed to brush the teeth twice daily for 5 days, using 1 gram of Yunnan Baiyao toothpaste (equivocal to approximately 6-7 lines on a standard toothbrush) for 3 minutes. 6.5 milligrams of Yunnan Baiyao active extract were contained in 1 gram of the toothpaste.
16166455|NCT01652625|Drug|Placebo toothpaste|One gram of the placebo toothpaste was used twice daily by the control group patients. Except for the active Yunnan Baiyao extract, all ingredients contained in the placebo-toothpaste were the same as that in the experimental toothpaste.
16166456|NCT01652612|Other|PEEP|8 cmH2O PEEP throughout the period of OLV and 2nd TLV
16166457|NCT01652599|Drug|Eltrombopag and dexamethasone|Eltrombopag 50 mg PO days 5-32 Dexamethasone 40 mg PO days 1-4
16166458|NCT01652586|Drug|dexmedetomidine-remifentanil|
16166459|NCT01652586|Drug|midazolam-remifentanil|
16166460|NCT01652573|Drug|nasal salmon calcitonin|400 IU daily in two sprays (one to each nares)
16166461|NCT01652573|Drug|Saline Nasal Spray Placebo|
16166462|NCT01652560|Drug|bevacizumab|The patients will be treated with Avastin combined neoadjuvant chemotherapy
16166463|NCT01652547|Drug|Pasireotide sub-cutaneous formulation|Pasireotide, will be administered to all patients by s.c. injection, beginning with a dose of 300 μg administered three times daily (t.i.d.) for 2 weeks. If no pasireotide-related clinically meaningful/uncontrolled grade 3 or grade 4 adverse events occur the dose will be administered to all patients at an increased dose of 600 μg t.i.d. for 2 weeks, followed by 2 weeks of 900 μg t.i.d. and followed by 2 weeks of 1200 μg t.i.d. After the 8 weeks period, patients will be kept on treatment drug (highest dose without clinically meaningful/uncontrolled AEs) , switched to the corresponding pasireotide LAR dose and followed up for an extra 6 months.
16166464|NCT01652547|Drug|Pasireotide lon acting release formulation|At the start of the follow-up phase patients will be switched to pasireotide LAR administered intramuscularly every 28 days by using the following conversion algorithm so that the steady state PK exposure (Cmax and Ctrough) of pasireotide will be maintained: 300 μg s.c. t.i.d. fi 20mg LAR i.m. q 28 days 600 μg s.c. t.i.d. fi 40 mg LAR i.m. q 28 days 900 μg s.c. t.i.d. fi 60 mg LAR i.m. q 28 days 1200 μg s.c. t.id. fi 80 mg LAR i.m. q 28 days In addition, all patients will keep the treatment with pasireotide s.c. during the first 2 weeks of the LAR phase. The use of s.c. dosing during the initial 2 week period following the first LAR dose provides an appropriate level of medication during the LAR nadir.
16166465|NCT01652534|Drug|Amantadine|Amantadine 100mg daily, for a week, if it is tolerated Amantadine will increase to 1 tab twice a day. Amantadine will then be administered orally twice daily in the morning with breakfast and at noon with lunch (AM and NN).
16166466|NCT01652534|Drug|Placebo|Sugar Pill
16166467|NCT01652508|Other|Control|Participants in the control group are provided a self-help leaflet on smoking cessation only
16166468|NCT01652508|Behavioral|Acceptance and Commitment Therapy|All participants are given an initial smoking cessation session via face to face by Acceptance and Commitment Therapy. Two other sessions using the same therapy will be provided by telephone. The total contact time by ACT will be 45 mins (15 mins per session).
16166469|NCT01652495|Drug|methylprednisolone acetate|Single intrabursal ultrasound guided injection of 40 mg (1 ml) of methylprednisolone acetate
16166470|NCT01652495|Drug|Triamcinolone Acetonide|Single intrabursal ultrasound guided injection of 40 mg (1 ml) of triamcinolone acetonide
16166471|NCT01652482|Drug|5-fluorouracil|Standard 5-fluorouracil (5-FU) chemotherapy (400 milligram per square meter [mg/m^2] administered as intravenous bolus and then 5-FU 2400 mg/m^2 administered as continuous intravenous infusion over 46 +/- 2 hours) or according to local standard-of-care prescribing information's, every 2 weeks until documented disease progression or unacceptable toxicity.
16166472|NCT01652482|Drug|Cetuximab|Cetuximab 400 mg/m^2 intravenous infusion as a loading dose on Day 1 Cycle 1, followed by 250 mg/m^2 intravenous infusion weekly until documented disease progression or unacceptable toxicity.
16166473|NCT01652482|Drug|Irinotecan|Standard Irinotecan chemotherapy (180 milligram per square meter [mg/m^2] administered as intravenous infusion over 60 +/- 30 minutes) or according to local standard-of-care prescribing information's, every 2 weeks until documented disease progression or unacceptable toxicity.
16166474|NCT01652482|Drug|Leucovorin|Standard Leucovorin chemotherapy (400 mg/m^2 [racemic form] or 200 mg/m^2 [L-isomer form] administered by intravenous infusion over 120 +/- 10 minutes) or according to local standard-of-care prescribing information's, every 2 weeks until documented disease progression or unacceptable toxicity.
16166475|NCT01652482|Drug|MEHD7945A|MEHD7945A 1100 milligram (mg) intravenous infusion every 2 weeks until documented disease progression or unacceptable toxicity.
16166476|NCT01652469|Drug|Erlotinib|Erlotinib 150 mg/day p.o. continuously with 21 days cycle.
16166477|NCT01652469|Drug|Docetaxel|Docetaxel 75 mg/m2 as an IV infusion every 21 days.
16166478|NCT01652456|Other|Addiction support|one consultation with an addiction specialist
16166479|NCT01652417|Drug|methylprednisolone bolus IV 15 mg/kg/d for 3 days.|methylprednisolone bolus IV 15 mg/kg/d for 3 days.
16166480|NCT01652404|Behavioral|Procalcitonin-guided treatment|The antibiotics duration will be determined by the serum procalcitonin level at day 5, 7 and 9.
16166481|NCT01652404|Behavioral|Conventional treatment|The antibiotics duration will be determined by treating physician.
16166482|NCT01652391|Device|Transcranial direct current stimulation (tDCS); DC-STIMULATOR (NeuroConn GmbH, Ilmenau, Germany)|
16166609|NCT01651572|Drug|Rocuronium|"Rocuronium (Esmeron):
~initial dose: 0.6 mg/kg
~maintaining dose: 0.15 mg/kg (repeated anytime TOF-count reaches 2 twitches)"
16319420|NCT00504127|Drug|placebo|placebo
16166483|NCT01652378|Drug|ondansetron, lidocaine|"Ondansetron: Ondansetron (0.15 mg/kg) will be administered through the IV line over 15 min at a constant rate of infusion.
~Lidocaine: Lidocaine will be administered as a 2mg/kg initial bolus over 5 minutes followed by a continuous intravenous infusion of lidocaine at a rate of 2mg/kg/hour for 55 min (60 min total infusion)."
16166484|NCT01652365|Behavioral|RDT Training and Subsidy Offered|
16166485|NCT01652365|Behavioral|Information/Education Campaign|
16166486|NCT01652339|Drug|Exforge tab. 10/160mg|
16166487|NCT01652339|Drug|Lodivixx tab. 5/160mg|
16166488|NCT01652326|Drug|Diazepam|
16166489|NCT01652313|Drug|Rasagiline|1 mg/day, tablets for 7 days, orally
16166490|NCT01652300|Behavioral|two educational sessions|The test group had two educational sessions lasting 1 hour, focused on oral and dental health and especially on oral and dental health during pregnancy
16166491|NCT01652300|Behavioral|no education|women in the control group received no education
16166492|NCT01652287|Drug|BB-12 supplemented strawberry yogurt|Bifidobacterium animalis subsp. lactis (B. lactis) strain BB-12 (BB-12) probiotic supplemented yogurt, 4 ounces taken orally for 10 days
16166493|NCT01652287|Other|Strawberry flavored yogurt|Placebo, strawberry yogurt, 4 ounces taken orally for 10 days
16166494|NCT01652261|Drug|ABVD + FDG-PET/CT Scan treatment adaptation|
16166495|NCT01652261|Drug|BEACOPPesc|
16166496|NCT01652248|Procedure|Cardiac resynchronisation therapy|Upgrade to CRT at the time of generator replacement
16166497|NCT01652235|Device|Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular Graft|Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
16166498|NCT01652222|Other|CONEM-BETA + socio-educational training|4 socio-educative training sessions during 8 weeks, and caregivers will systematically play with their patients with CONEM-BETA therapeutic game during the last 4 weeks. The dyads will be assessed (primary timepoint). Caregivers will then continue using the game with their patients for an extra 6 weeks period as needed, to assess adherence and games preferences.
16166499|NCT01652222|Other|Socio-educational training only|4 socio-educative training sessions during 8 weeks
16166501|NCT01652196|Biological|aflibercept|4 mg/kg as a 1-hour IV(intervenous) infusion
16166502|NCT01652196|Drug|oxaliplatin|85 mg/m2 IV infused over 2 hours
16166503|NCT01652196|Drug|leucovorin|200 mg/m2 (Or levoleucovorin 100 mg/m2. If leucovorin is not available due to drug shortages the regimen should be administered with the leucovorin omitted) IV over 2 hours. Alternatively, leucovorin may be administered (via separate infusion lines) concurrently with oxaliplatin
16166504|NCT01652196|Drug|fluorouracil|400 mg/m2 IV bolus over 5-15 minutes, then 2400 mg/m2 continuous IV infusion over 46 hours.
16166505|NCT01652196|Other|Correlative Studies|Patients are required to have tissue available before enrolling on the study. A fresh biopsy is only required if there is insufficient material for analysis. Repeat tumor biopsies after 8 weeks of therapy are optional and will only be performed at the Ohio State University Medical Center.
16166506|NCT01652196|Procedure|DCE MRI|Images at weeks 0, and after 8 weeks +/- 1 week of treatment (after Cycle 2).
16166507|NCT01652196|Radiation|f18FDG-PET|18FDG-PET is a functional imaging technique that relies on tumor uptake of radiolabeled tracer 18 fluorodeoxyglucose (18FDG). FDG-PET is a widely-used imaging modality in the detection and monitoring of a variety of metastatic cancers, including colorectal cancer (99-102).
16166508|NCT01652196|Procedure|PET (positron emission tomography)|Correlative studies
16166509|NCT01652183|Drug|intravenous paracetamol|
16166510|NCT01652183|Drug|Placebo|
16166511|NCT01652157|Biological|ULTRESA|pancreatic enzyme replacement therapy
16166512|NCT01652157|Biological|PANCREAZE|pancreatic enzyme replacement therapy
16166513|NCT01652157|Biological|CREON|pancreatic enzyme replacement therapy
16166514|NCT01652157|Biological|ZENPEP|pancreatic enzyme replacement therapy
16166515|NCT01652157|Biological|other non-sponsor pancreatic enzyme replacement therapy|pancreatic enzyme replacement therapy
16166516|NCT01652157|Biological|PERTZYE|pancreatic enzyme replacement therapy
16166517|NCT01652157|Other|No pancreatic enzyme replacement therapy|Cystic fibrosis patients in the cystic fibrosis registry not receiving any pancreatic enzyme replacement therapy (approximately 10%)
16166518|NCT01652144|Drug|AT7519M|
16166519|NCT01652131|Other|Tetrastarch (130/0.4)|
16166520|NCT01652118|Drug|clarithromycin treatment for prophylaxis of bronchopulmonary dysplasia|
16166521|NCT01652118|Drug|Saline|
16166522|NCT01652105|Dietary Supplement|Standard diet versus standard VLCD (Prodimed)|
16166523|NCT01652092|Drug|Alemtuzumab 0.3 mg|0.3 mg/kg intravenously (IV) on days -12 through -10
16166524|NCT01652092|Drug|Cyclophosphamide|cyclophosphamide 50 mg/kg IV on days -9 through -6
16166525|NCT01652092|Drug|Busulfan|busulfan 0.8 or 1.1 mg/kg IV on days -5 through -2
16166526|NCT01652092|Biological|Stem Cell Transplantation|"Unrelated donor bone marrow will be collected in the usual manner using established parameters determined by the National Marrow Donor Program. A minimum of 3 x 10^8 nucleated cells/kg recipient weight will be collected with a goal of ≥ 5 x 10^8 nucleated cells/kg recipient weight.
~Umbilical cord blood selection will be per the current University of Minnesota Cord Blood Unit Selection algorithm. One or two units may be used to obtain the minimum cell dose. One of the UCB units selected for transplantation must contain ≥ 3.5 x 10^7 nucleated cells/kg recipient weight based on cell numbers at time of cryopreservation, and the total combined cell dose of both units must be > 5.0 x 10^7 nucleated cells/kg."
16166527|NCT01652092|Drug|Fludarabine phosphate 40 mg|40 mg/m^2 IV on days -5 through -2 (for children < 6 months and/or < 10 kg weight dose at 1.33 mg/kg)
16166528|NCT01652092|Drug|Melphalan|140 mg/m^2 IV on day -3
16166529|NCT01652092|Drug|Alemtuzumab 0.2 mg|0.2 mg/kg intravenously (IV) on days -14 through -10
16166530|NCT01652092|Drug|Busulfan|busulfan 0.8 or 1.1 mg/kg IV on days -9 through -6
16166531|NCT01652092|Drug|Fludarabine phosphate 30 mg|fludarabine 30 mg/m^2 IV on days -8 through -4
16166532|NCT01652092|Drug|MESNA|administered as per the standard institutional protocol.
16166533|NCT01652079|Drug|CRLX101|q 14 days
16167058|NCT01648023|Drug|Gem-Cis or Gem-Carbo|
16166534|NCT01652066|Dietary Supplement|Mixture of probiotics|effect of the consumption a mixture of probiotics ( dietary supplement tablet - dosage at least 10x7 cfu/g) during 7 weeks , once a day , healthy volonteers ) on the antigen specific antibody respense
16166535|NCT01652066|Dietary Supplement|Mixture of probitiocs|effect of the consumption a mixture of probiotics ( dietary supplement tablet - dosage at least 10x7 cfu/g) during 7 weeks , once a day , healthy volonteers ) on the antigen specific antibody respense
16166536|NCT01652053|Device|Disc Nucleus Replacement (InterCushion DNP)|The device is intended for spinal arthroplasty in skeletally mature patients with leg pain due to a herniated disc with or without back pain, who are having a discectomy at one level from L2 -S1. These patients should have no spondylolisthesis at the involved level.
16166537|NCT01652040|Device|Resistance Training and Testosterone Patches|We are going to activate the knee extensor muscle group to lift ankle weights over 16 weeks and we are going to provide Tp to improve anabolic profile.
16166538|NCT01652040|Drug|Testosterone Patches|The investigators will provide Tp patches for 16 weeks for patients with Spinal Cord Injury.
16166539|NCT01652027|Drug|FVIII concentrate|usual treatment as directed by treating physician
16166540|NCT01652014|Drug|cyclophosphamide|Given IV over 1 hour on Day -6; after pre-hydration
16166541|NCT01652014|Drug|fludarabine phosphate|Given IV daily over 30 minutes for 5 days (Days -6 to -2)
16166542|NCT01652014|Drug|mycophenolate mofetil|Given PO 1.0 g BID Day 1-30
16166543|NCT01652014|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo double-unit allogeneic UCB transplant
16166544|NCT01652014|Procedure|umbilical cord blood transplantation|Undergo single allogeneic UCB transplant
16166545|NCT01652014|Procedure|double-unit umbilical cord blood transplantation|Undergo double-unit allogeneic UCB transplant
16166546|NCT01652014|Radiation|total-body irradiation|Undergo TBI
16166547|NCT01652014|Drug|tacrolimus|Given IV 0.03 mg/kg/d as continuous infusion over 24 hours starting Day -3 with dose adjustments to maintain level of 8-20 mg/ml
16166548|NCT01652014|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo single allogeneic UCB transplant
16166549|NCT01652014|Procedure|peripheral blood stem cell transplantation|Undergo irradiated allogeneic peripheral blood stem cell transplant
16166550|NCT01652001|Drug|Malic Acid|Oral spray for application into the oral cavity
16166551|NCT01652001|Other|Placebo|Oral spray for application into the oral cavity
16166552|NCT01651988|Drug|Ketamina-Propofol Combination|"After randomization to the study group, the patients were given:
~Procedures < 10 minutes
~Ketamine-Propofol Combination KETOFOL 1:1
~Propofol: 0.2 cc/kg (10 mg/cc = 2 mg/kg)
~Ketamine: cc/kg 0.04 (50 mg/cc = 2 mg/kg)
~Simple 1% lidocaine: 0,1 cc/kg (10 mg/cc = 1 mg/kg)
~Ketamine-Propofol Combination KETOFOL 1:2
~Propofol: 0.2 cc/kg (10 mg/cc = 2 mg/kg)
~Ketamine: 0.02 cc/kg (50 mg/cc = 1 mg/kg)
~Simple 1% lidocaine: 0,1 cc/kg (10 mg/cc = 1 mg/kg)
~Procedures > 10 minutes
~In addition to the initial bolus, an infusion was started:
~KETOFOL 1:1
~20 cc of propofol (10 mg/cc = 200 mg in total) 4 cc of ketamine (50 mg/cc = 200 mg in total) 10cc lidocaine 1% simple (10 mg/cc = 100 mg in total) 66 cc 0.9% SSN
~KETOFOL 1:2
~20 cc of propofol (10 mg/cc = 200 mg in total) 2 cc of ketamine (50 mg/cc = 100 mg in total) 10cc lidocaine 1% simple (10 mg/cc = 100 mg in total) 68 cc 0.9% SSN
~Speed infusion:
~0,03cc/kg/min"
16166553|NCT01651975|Dietary Supplement|Thickenup|given two 1-cc boluses of liquid contrast agent (barium), one 3-cc of thin liquid contrast, one 3-cc of paste, one cookie with contrast, one 20-cc bolus of liquid contrast, and one 20-cc bolus of thin liquid contrast. The patients are then studied in the anterior/posterior view with one 1-cc, one 3-cc, and one 20-cc bolus of thin liquid barium 1-4. At the end of the protocol patients are routinely administered products with either starch or gel based thickener to evaluate the swallowing safety of the thickened agent. The protocol includes a 3-minute limitation on total fluoroscopy time to ensure clinician and patient safety.
16166554|NCT01651975|Dietary Supplement|Thickenup Advance|given two 1-cc boluses of liquid contrast agent (barium), one 3-cc of thin liquid contrast, one 3-cc of paste, one cookie with contrast, one 20-cc bolus of liquid contrast, and one 20-cc bolus of thin liquid contrast. The patients are then studied in the anterior/posterior view with one 1-cc, one 3-cc, and one 20-cc bolus of thin liquid barium 1-4. At the end of the protocol patients are routinely administered products with either starch or gel based thickener to evaluate the swallowing safety of the thickened agent. The protocol includes a 3-minute limitation on total fluoroscopy time to ensure clinician and patient safety.
16166555|NCT01651962|Drug|Terbutaline|
16166556|NCT01651962|Drug|Fentanyl|
16166557|NCT01651962|Drug|0.9% NaCl|
16166558|NCT01651949|Biological|9vHPV Vaccine|9vHPV, V503 (9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine), 0.5 mL injection in 3-dose regimen
16166559|NCT01651936|Drug|MK-8457 100 mg|MK-8457 100 mg dosed orally BID
16166560|NCT01651936|Drug|Methotrexate|MTX dosed at the stable dose received upon study entry
16166561|NCT01651936|Drug|Dose-match placebo|Dose-matched placebo dosed orally BID
16166562|NCT01651923|Drug|Heparin|Whereas it will be a crossover study with two periods, each drug will be administered only once, at a dose of 5.000UI. In each period, the drug will be administered intravenously.
16166563|NCT01651884|Device|HD-tDCS (Soterix)|Subjects will be given individualized dose (number of electrodes and electrode placement) through High-Definition electrodes to target fMRI determined targets
16166564|NCT01651884|Device|Transcranial Direct Current Stimulation (Neuroconn)|
16166565|NCT01651871|Drug|S-555739 Dose 1|
16166566|NCT01651871|Drug|S-555739 Dose 2|
16166567|NCT01651871|Drug|Cetirizine HCl Dose 1|
16166568|NCT01651871|Drug|S-555739 placebo|
16166569|NCT01651871|Drug|Cetirizine HCl placebo|
16166570|NCT01651858|Drug|Nurigra Chewable tablet|1 tablet of 100mg, once a day
16166571|NCT01651832|Behavioral|SCAN|The Supportive Cancer Care Networkers intervention (SCAN) consists of an additional telephone support and symptom-related out-patient care management through Oncology Nursing. The SCAN intervention assesses patients' resources and barriers in utilizing health care services in order to meet their individual needs adequately and supports maintenance of therapy compliance. Thus, the SCAN offers a comprehensive mirroring the patients' medical and psychosocial care needs across changing sectors of health care.
16166610|NCT01651546|Behavioral|Intermittent catheterization test|I-CAT will be a self assessment questionnaire and a simple, comprehensive and quickly passed questionnaire.
16166572|NCT01651819|Procedure|Urological physical therapy|Individual patient attending with one hour duration beginning with Behavior therapy and education, teaching urinary maneuvers, water adequate intake. Second part is manual therapy an Kinesiotherapy with specific exercises, followed by patient repetition. Last part is constituted by electrotherapy for specific muscle stimulation and biofeedback.
16166573|NCT01651806|Drug|Tranexamic Acid standard dose|Uniform 1 gram dosing
16166574|NCT01651806|Drug|Females Tranexamic Acid weighted dose|Weighted dose--20mg/kg of the drug will be given
16166575|NCT01651806|Drug|Females receiving a uniform dose of TA|Patients will receive a uniform 1 gm dose of tranexamic acid prior to tourniquet release during a primary TKA.
16166576|NCT01651806|Drug|Males Weighted Dose TA|Weighted dose--20mg/kg of the drug will be given
16166577|NCT01651793|Other|Caffeinated cocoa|70 mg caffeine, 179 mg theobromine, 499 mg flavanols, and 1 packet of Truvia sweetener
16166578|NCT01651793|Other|Cocoa|21 mg caffeine, 179 mg theobromine, 499 mg flavanols, and 1 packet of Truvia sweetener
16166579|NCT01651793|Other|Caffeine|473 ml brewed water containing 66 mg caffeine, caramel coloring and one packet Truvia sweetener
16166580|NCT01651793|Other|Placebo|473 ml of brewed water, caramel coloring and one packet Truvia sweetener
16166581|NCT01651780|Drug|Bivalirudin|Bivalirudin is an anticoagulant that binds directly to thrombin in a bivalent and reversible fashion.
16166582|NCT01651780|Drug|Unfractionated Heparin|Unfractionated heparin is an anticoagulant.
16166583|NCT01651767|Drug|Placebo|Form=suspension, route=oral.
16166584|NCT01651767|Drug|JNJ-47910382|Type=exact number, unit=mg, number=30, 90, 300, 400 or 450, form=suspension, route=oral. Study drug will be administered once or twice daily
16166585|NCT01651754|Biological|Seasonal influenza vaccination|single dose of influenza vaccination
16166586|NCT01651741|Dietary Supplement|Seaweed and Duolac7S|"Seaweed and probiotics is composed of seaweed and Duolac7S.
~Seaweed:
~Form: brown granule
~Dosage and frequency: 1 pack (3 g), 2 packs per day (30 min after morning, and evening meal)
~Duration: 4 weeks of treatment period
~Duolac7S:
~The probiotics, Duolac7S, consist of 7 bacteria.
~Ingredients: Lactobacillus acidophilus, L. plantarum, L. rhamnosus, Bifidobacterium breve, B. lactis, B. longum, Streptococcus thermophilus.
~Dosage and frequency: 1 capsule (5✕1,000,000,000 bacteria/capsule [7✕100,000,000 viable cells/strain]), 2 capsules per day (30 min after morning and evening meal)
~Duration: 4 weeks of treatment period"
16166587|NCT01651741|Dietary Supplement|Seaweed and Duolac7S-P|"Seaweed and probiotics is composed of seaweed and Duolac7S-P(Placebo Duolac7S).
~Seaweed:
~Form: brown granule
~Dosage and frequency: 1 pack (3 g), 2 packs per day (30 min after morning, and evening meal)
~Duration: 4 weeks of treatment period
~Duolac7S-P:
~Duolac7S placebo has the same form, color and flavor as experimental intervention (Duolac7S). The dosage, frequency and duration is also the same as experimental intervention (Duolac7S)."
16166588|NCT01651728|Drug|Simvastatin|Tablet 20 mg once daily for 30 days
16166589|NCT01651728|Drug|Placebo|daily for 30 days
16166590|NCT01651715|Drug|TAO1, oral homeopathic antibodies|"TAO1 comprises a mixture of homeopathic dilutions C12+C30+C200 (drug product is made by impregnation of pre-made tablets).
~The investigational product will be taken for 7 days as follow:
~Day 1: 3 tablets over the first 2 hours of treatment, then 3 tablets over the rest of Day 1.
~Days 2-3: 5 tablets/day (intakes distributed evenly over the daytime). Days 4-7: 3 tablets/day (intakes distributed evenly over the daytime)."
16166591|NCT01651702|Device|Carto|Group of patients where Carto Express system will be used for electroanatomical mapping.
16166592|NCT01651702|Device|Ensite|Group of patients where Ensite Velocity system will be used for electroanatomical mapping.
16166593|NCT01651676|Other|VQ11 validation|"Two visits per patient are planned: V1 and V2.
~For each visit, the pulmonologists ask the patients participating in the study to fill out the VQ11 questionnaire, which will be correlated to the other parameters (Likert scale, IPAQ, RFE, SGRQ,...)
~LABD treatment consist in β 2 agonists or anticholinergic drug."
16166594|NCT01651663|Drug|Arbidol (Umifenovir)|Arbidol (Umifenovir)/Placebo will be administered at a dosage of 800 mg/day (2 capsules q.i.d.) for 5 days.
16166595|NCT01651663|Other|placebo|Arbidol (Umifenovir)/Placebo will be administered at a dosage of 800 mg/day (2 capsules q.i.d.) for 5 days.
16166596|NCT01651663|Drug|Arbidol (Umifenovir)|Medically healthy exposed subjects will be administered Arbidol (Umifenovir)/Placebo at a dosage of 200 mg/day (2 capsules q.d.) for 10 days.
16166597|NCT01651663|Other|placebo|Medically healthy exposed subjects will be administered Arbidol (Umifenovir)/Placebo at a dosage of 200 mg/day (2 capsules q.d.) for 10 days.
16166598|NCT01651650|Device|Inhalation through Chiesi NEXThaler DPI|Inhalatory manoeuvre through Chiesi NEXThaler DPI repeated at least twice in order to have two evaluable data set
16166599|NCT01651637|Drug|synthetic surfactant (CHF5633)|CHF5633 100 mg/kg; CHF5633 200 mg/kg synthetic surfactant sterile suspension in 3.0 ml glass vials with a total concentration of 80 mg/ml for intratracheal administration. Single administration
16166600|NCT01651624|Other|Invitation to screening|
16166601|NCT01651611|Behavioral|Motivational interviewing|The TTA will use motivational interviewing (MI) techniques to assess the participant's motivation and readiness to quit, suggest plans, and assist the participant in selecting a method of treatment.
16166602|NCT01651611|Behavioral|Smoking cessation counseling|The TTA will provide information to the participant regarding evidence-based treatments for smoking cessation, including counseling and nicotine replacement therapy (NRT); assist in a quit plan; and discuss issues such as obtaining social support, staying in treatment, and dealing with lapses.
16166603|NCT01651611|Behavioral|Navigation to smoking cessation resources|The TTA will assist participants in obtaining NRT and getting connected to smoking cessation counseling services, such as the Smokers' Quitline and clinic-based programs.
16166604|NCT01651611|Behavioral|Social support|Meetings with the TTA will be a source of social support for the participant as they attempt to quit or stay quit.
16166605|NCT01651598|Drug|Placebo to BI 144807|multiple dose (bid)
16166606|NCT01651598|Drug|BI 144807|multiple dose (bid, low to high dose)
16166607|NCT01651585|Drug|Valacyclovir arrow|dosage form:500mg, dosage:8g/day, frequency: 4 a day duration: 23 weeks maximum
16166608|NCT01651572|Drug|Cisatracurium|"Cisatracurium (Nimbex):
~initial dose: 0.2 mg/kg
~maintaining dose: 0.1 mg/kg (repeated anytime TOF-count reaches 2 twitches)"
16166688|NCT01650844|Other|School-Based Telemedicine Enhanced Asthma Management|
16166611|NCT01651533|Behavioral|Mental Practice Group|Patients are administered rehabilitative therapy targeting their affected arms on 3 days/week during a ten week period. Directly after the therapy session, they participate in targeted mental practice session in which they cognitively rehearse the movement that they just physically practiced.
16166612|NCT01651533|Behavioral|Active Control Group|Individuals assigned to this group are administrated rehabilitative therapy targeting their affected arms in half four increments, occurring 3 days/week for 10 weeks. They also are administered an intervention in which they listen to a relaxation tape and/or tapes in which they receive instructions on exercises and information on stroke care.
16166613|NCT01651520|Drug|PET with 11C-Flumazenil|PET with 11C-Flumazenil.
16166614|NCT01651494|Drug|DAS181|DAS181-F04 is a recombinant neuraminidase that is delivered onto the cell surface of the upper and central airway topically and locally through an inhaler as an encapsulated dry powder. DAS181-F04; 20 mg single-dose each day via oral inhalation for 3 days; 6 subjects
16166615|NCT01651494|Other|Placebo|Placebo: White to off-white powder with Lactose Monohydrate and 5 % moisture; 20 mg single-dose each day via oral inhalation for 3 days; 3 subjects
16166616|NCT01651481|Drug|HCP1102|
16166617|NCT01651481|Drug|Singulair and Xyzal|
16166618|NCT01651468|Dietary Supplement|HEMOFIX|unique complex herbal mixture
16166619|NCT01651442|Behavioral|Behavioral Insomnia Therapy|Sleep hygiene, stimulus control, and sleep restriction presented in four sessions.
16166620|NCT01651442|Drug|Zolpidem|5mg or 10mg
16166621|NCT01651442|Drug|Trazodone|50mg to 150mg
16166622|NCT01651442|Behavioral|Cognitive Therapy|Cognitive restructuring, constructive worry, behavioral experiments presented in four sessions.
16166623|NCT01651429|Behavioral|Sleep deprivation|Participants will undergo 29 hours of sleep deprivation. They will wake up at 7:00 am on the day of the study and remain awake in the laboratory until 12:00 pm the next day.
16166624|NCT01651416|Drug|Artemether-lumefantrine combination|
16166625|NCT01651416|Drug|Dihydroartemisinin Piperaquine combination|
16166626|NCT01651416|Drug|Amodiaquine plus sulphadoxine-pyrimethamine combination|
16166627|NCT01651403|Drug|Tenofovir DF|"Participants weighing ≥ 17 kg will receive TDF one tablet administered orally once daily (150, 200, 250 or 300 mg tablets based on body weight).
~Participants weighing < 17 kg or ≥ 17 kg who are unable to swallow a tablet will receive TDF oral powder in a dose of 8 mg/kg once daily up to a maximum dose of 300 mg."
16166628|NCT01651403|Drug|TDF Placebo|"Participants weighing ≥ 17 kg will receive TDF placebo tablet administered orally once daily.
~Participants weighing < 17 kg or ≥ 17 kg who are unable to swallow a tablet will receive TDF placebo oral powder once daily."
16166629|NCT01651390|Device|Percutaneous coronary intervention|Up to 140 patients meeting the inclusion criteria and none of the exclusion criteria are randomly selected and stratified according to diabetic status at screening are treated with the Pantera Lux drug coated balloon.
16166630|NCT01651390|Device|Percutaneous coronary intervention|Up to 70 patients meeting the inclusion criteria and none of the exclusion criteria are randomly selected and stratified according to diabetic status at screening are treated with the Orsiro drug eluting stent.
16166631|NCT01651377|Drug|Pramipexole|Participants will receive pramipexole ER 0.375, .075, 1.5, 2.25, and 3mg/d in an ascending-dose pattern.
16166632|NCT01651377|Drug|Placebo|Participants will receive matching placebo pills. The placebo group is included to maintain the blind, rather than as a comparison group.
16166633|NCT01651364|Drug|Placebo|Enrolled volunteers will be randomized on Day 8 to receive placebo (n=2) or study medication (n=8). Placebo serves only to maintain the blind and is not a comparator.
16166634|NCT01651364|Drug|Cabergoline|Enrolled volunteers that receive study medication (n=8) will receive cabergoline 0.25 mg twice weekly.
16166635|NCT01651351|Biological|Alpha1-proteinase inhibitor|GLASSIA will be supplied as a sterile, non-pyrogenic, ready-to-use solution, in single dose 50 mL vials; for intravenous administration.
16166636|NCT01651351|Biological|Placebo: Human albumin 2.5%|Intravenous administration
16166637|NCT01651338|Procedure|acupuncture|The patients went through acupuncture for 8 -10 sessions and either once or two times a week. The number and the place of needles were 8 -12 for each patient which were located on the right place.
16166638|NCT01651325|Drug|Isavuconazole|oral
16166639|NCT01651325|Drug|dextromethorphan|oral
16166640|NCT01651312|Drug|14C-labeled YM178|oral solution (1.85 MBq)
16166641|NCT01651286|Procedure|nasal mask|Using the nasal mask instead of the full face mask during the induction of general anesthesia
16166642|NCT01651286|Procedure|full face mask|using a standard full face mask during the induction of general anesthesia.
16166643|NCT01651273|Drug|BMS-852927|Capsules, Oral, 0.25 mg, Once daily, 28 days
16166644|NCT01651273|Drug|BMS-852927|Capsules, Oral, 1.0 mg, Once daily, 28 days
16166645|NCT01651273|Drug|BMS-852927|Capsules, Oral, 2.5 mg, Once daily, 28 days
16166646|NCT01651273|Drug|Placebo|Capsules, Oral, 0 mg, Once daily, 28 days
16166647|NCT01651260|Other|Experimental ET Tube Securement Device|Experimental Hollister device with bite block was substituted for standard-of-care device during the study period.
16166648|NCT01651247|Procedure|Serum sample|Serum samples collected at pre-determined time points in previously completed studies (217744/085 and 213503/048) will be analysed to detect the presence of anti PCV-1 antibodies.
16166649|NCT01651234|Drug|GCC-4401|"Swedish Orange opaque hard gelatin capsules of size 1 with no markings for oral use
~single dose
~dosage
~Cohort 1: 2.5-mg GCC-4401C
~Cohort 2: 5.0-mg GCC-4401C
~Cohort 3: 10-mg GCC-4401C
~Cohort 4: 20-mg GCC-4401C
~Cohort 5: 40-mg GCC-4401C
~Cohort 6: 80-mg GCC-4401C"
16166650|NCT01651234|Drug|GCC-4401C|"Capsule, identical in appearance to GCC-4401C, for oral use
~single dose
~dosage
~Cohort 1: 2.5-mg matching placebo
~Cohort 2: 5.0-mg matching placebo
~Cohort 3: 10-mg matching placebo
~Cohort 4: 20-mg matching placebo
~Cohort 5: 40-mg matching placebo
~Cohort 6: 80-mg matching placebo"
16166651|NCT01651221|Other|Habituation|Habituation will be measured for each the conditions (olfactory, gustatory, olfactory and gustatory) of the study.
16166689|NCT01650844|Other|Enhanced Usual Care|
16166690|NCT01650831|Device|Modified BreathID|A new modified device, compared to the originally cleared BreathID measures breath from a subject via a nasal cannula
16166727|NCT01650558|Drug|Chloroquine (CQ) prophylaxis|Discontinue standard of care and start weekly CQ.
16166652|NCT01651208|Behavioral|Motivational Interviewing (MINT)|"We will hire a Latino and an AA nurse to deliver the interventions and will match their race/ethnicity with that of the subject. Past experience suggests that at 4-7 calls per subjects each lasting about 30-45 minutes, a nurse can carry a caseload of about 125-150 subject (we propose 125 per nurse) Each telephone encounter will have a patient centered approach having the following basic structure and goals:
~a)Establishing a connection and reinforcing autonomy b)Empathizing with ambivalence and rolling with resistance.c)Coach the subject towards expressions of commitment."
16166653|NCT01651208|Behavioral|Mailed DVD|The DVD will have a documentary format that will engage subjects as the portrayed real patients relate their struggles and successes, that will entertain and ultimately motivate subjects to succeed in a similar way as the role models in the video. That personal connection will activate patients to address their own adherence issues and will show real life ways to deal with the health behaviors recommended post PCIS. Key concepts regarding adherence to medications and other behaviors will be imbedded in the story telling. The DVD will also feature a humanistic perspective of a cardiologist talking about his concerns for his patients that do not adhere to the antiplatelet therapy, the difficulties that his patients face, and the merit of the success stories he witnesses.
16166654|NCT01651195|Dietary Supplement|Probiotic|
16166655|NCT01651195|Other|Placebo|
16166656|NCT01651182|Drug|No tranexamic acid|Control
16166657|NCT01651182|Drug|Tranexamic Acid|
16166658|NCT01651169|Other|methylphenidate tablets and Inter-stimulus Intervals (ISI)|"We administer 2 single doses of methylphenidate tablets (10mg) separated by a week interval. A paired pulse protocols will be performed with ten single (unconditioned test pulse) and ten paired TMS pulses (conditioning and test pulse) in an intermixed randomized order.
~Short interval cortical inhibition is measured with an Inter-stimulus Intervals (ISI) of 3 msec and a stimulator output of 80% RMT for the conditioning stimulus and 1mVT stimulation intensity for the test stimulus. ICF investigation is measured with an ISI of 13 msec), with the condition of an ISI of 50 msec (ISI 50) and both stimuli applied with 1mVT intensity). Long Interval Cortical Inhibition (LICI) is measured with ISIs of 100 msec (ISI 100), 200 msec (ISI 200), and 300 msec (ISI 300); both stimuli with 1mVT intensity"
16166659|NCT01651169|Other|methylphenidate tablets and Inter-stimulus Intervals (ISI)|"We administer 2 single doses of methylphenidate tablets (10mg) separated by a week interval. A paired pulse protocols will be performed with ten single (unconditioned test pulse) and ten paired TMS pulses (conditioning and test pulse) in an intermixed randomized order.
~Short interval cortical inhibition is measured with an Inter-stimulus Intervals (ISI) of 3 msec and a stimulator output of 80% RMT for the conditioning stimulus and 1mVT stimulation intensity for the test stimulus. ICF investigation is measured with an ISI of 13 msec), with the condition of an ISI of 50 msec (ISI 50) and both stimuli applied with 1mVT intensity). Long Interval Cortical Inhibition (LICI) is measured with ISIs of 100 msec (ISI 100), 200 msec (ISI 200), and 300 msec (ISI 300); both stimuli with 1mVT intensity."
16166660|NCT01651156|Drug|Tolvaptan|oral taken
16166661|NCT01651156|Drug|Placebo|
16166662|NCT01651143|Drug|SAR100842|"Pharmaceutical form: tablets
~Route of administration: oral"
16166663|NCT01651143|Drug|Placebo (for SAR100842)|"Pharmaceutical form: tablets
~Route of administration: oral"
16166664|NCT01651130|Drug|Carbetocin|Carbetocin IV, over 1 minute following delivery of the fetal head. Doses: 2, 5, 10, 15, 20 or 100mcg
16166665|NCT01651117|Behavioral|Peer Mentoring|Patients will receive peer mentoring.
16166666|NCT01651104|Biological|Adjuvanted Trivalent Influenza Virus Vaccine (aTIV)|A single 0.5 mL dose of study vaccine supplied in prefilled syringes was administered intramuscularly in the deltoid muscle, preferably of the non dominant arm.
16166667|NCT01651091|Other|Meditation Awareness Training|Psychotherapy Intervention
16166668|NCT01651091|Other|Treatment as usual|
16166669|NCT01651065|Behavioral|Microclinic Diabetes Education Program|"The microclinic intervention leverages different levels of social networks to positively influence behaviors relating to diabetes and other metabolic conditions through small treatment units called, 'microclinic groups (MC),' consisting of 2-6 friends and family members of the same social network, which lead to a larger network of 'classes' and cohorts.
~The program provides MC subjects with shared access to health education and group support to promote glycemic and metabolic control through diet, exercise, and treatment adherence. MC members play a role in the collective effort to combat diabetes and solidifying self-management behavioral skills through peer-monitoring and encouragement of lifestyle behaviors."
16166670|NCT01651065|Behavioral|Control|
16166671|NCT01651052|Procedure|Heart Valve Surgery|Implant of an aortic valve, Model 11000
16166672|NCT01651039|Drug|Panobinostat|Each cycle is 28 days. Panobinostat will be given 20 mg: Days 1,3,5,15,17,19.
16166673|NCT01651039|Drug|Lenalidomide|Each cycle is 28 days. Lenalidomide will be given 25 mg: Days 1-21.
16166674|NCT01651039|Drug|Dexamethasone|Each cycle is 28 days. Dexamethasone will be given for patients 75 years old and younger a dose of 40 mg on Days 1, 8 and 15. Dexamethasone will be given for patients older than 75 years old, 20 mg on Days 1, 8 and 15.
16166675|NCT01651000|Drug|CTAP101 30 μg capsules|CTAP101 30 μg capsule taken daily at bedtime.
16166676|NCT01651000|Other|Sugar pill to CTAP101 30 μg capsules|Sugar pill capsule (placebo to CTAP101 30 μg capsule) taken daily at bedtime.
16166677|NCT01650974|Device|HFNOT|high flow nasal oxygen therapy
16166678|NCT01650961|Drug|Palonosetron|0.075 mg IV as bolus before induction of general anesthesia
16166679|NCT01650961|Drug|Normal saline|2 ml normal saline as bolus before induction of general anesthesia
16166680|NCT01650948|Device|RetnaGene AMD LDT|
16166681|NCT01650935|Behavioral|diet|When the first set of urine samples confirmed hyperoxaluria (urine oxalate>32.8), the patients will enter the study. After a run-in period of 3 weeks patients are allocated into 2 groups that I already explained in the arms section.The patients are visited in the beginning, after 6 weeks and at the end of the study
16166682|NCT01650922|Procedure|phlebotomy|
16166683|NCT01650922|Procedure|biopsy|
16166684|NCT01650896|Other|Geriatric assessment review|Adjust medications, treat precipitants of delirium, one-on-one supervision of agitated violent patients
16166685|NCT01650883|Dietary Supplement|Cholecalciferol|Cholecalciferol 50,000 IU PO every 10 days for 40 days
16166686|NCT01650883|Dietary Supplement|Cholecalciferol 5,000 IU|Cholecalciferol 5,000 IU PO daily for 40 days + 1200 mg Calcium Carbonate PO daily for 40 days.
16166687|NCT01650870|Drug|Crystalline Lactulose|
16166691|NCT01650818|Other|Aerobic exercise training|Intensity: heart rate corresponding to 40% peak VO2. Frequency: 5 sessions/week. Duration: 5 min warm-up + 20 min training + 5 min cool-down during the 1st month; 5 min warm-up + 30 min training + 5 min cool-down during the 2nd and 3rd month
16166692|NCT01650818|Other|Standard physical therapy (Stretching/Range-of-motion)|Intensity: N/A. Frequency: 5 sessions/week. Duration: 5 min warm-up + 20 min training + 5 min cool-down during the 1st month; 5 min warm-up + 30 min training + 5 min cool-down during the 2nd and 3rd month
16166693|NCT01650805|Drug|ponatinib|45 mg tablet, taken orally once daily
16166694|NCT01650805|Drug|imatinib (Gleevec/ Glivec)|400 mg tablet, taken orally once daily
16166695|NCT01650792|Drug|Aspirin|
16166696|NCT01650779|Biological|Agalsidase beta|Commercially available agalsidase beta 1.0 mg/kg administered as an intravenous infusion q2w up to Month 6.
16166697|NCT01650753|Dietary Supplement|Probiotic Powder|Bifidobacterium longum subsp longum AH1206 freeze dried and provided as a powder in a sachet (10^10 cells/sachet)
16166698|NCT01650753|Dietary Supplement|Placebo powder|powdered maltodextrin inthe same volume and the freeze dried probiotic in a similar size sachet
16166699|NCT01650740|Drug|Duloxetine|30 mg daily x 1 week followed by 60 mg daily
16166700|NCT01650740|Drug|placebo|small placebo capsule (30 mg duloxetine equivalent) x 1 week followed by 60 mg equivalent capsule daily
16166701|NCT01650740|Other|Study visits only|Weekly visits x 4 weeks followed by visits every 2 weeks
16166702|NCT01650727|Drug|Dinaciclib|Dinaciclib is given as a single intravenous (IV) dose on Days 1, 8, and 15 in Cycle 2 through Cycle 13 (28 day cycles) at a starting dose of 7 mg/m^2 up to a maximum dose of 14 mg/m^2.
16166703|NCT01650727|Biological|Rituximab|Rituximab 375 mg/m^2 will be administered IV on Day 1, 8, 15 and 22 in Cycle 1 (28 day cycle) and on Day 1 in Cycles 3-13 (28 day cycles).
16166704|NCT01650714|Other|Full thickness gastric biopsy|
16166705|NCT01650714|Procedure|Full thickness gastric biopsy|
16166706|NCT01650701|Drug|Rituximab|• Rituximab, 375 mg/m2 on days 1, 8, 15 and 22 of cycle 1, day 1 of cycles 2 to 6; 8 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.
16166707|NCT01650701|Drug|Lenalidomide|• Lenalidomide dose 20-mg on days 2-22 every 28 days x 6 cycles, if CR then 10-mg on days 2-22 every 28 days for 12 cycles. PR after 6 cycles, continue 20 mg for 3~6 cycles and then 10 mg on days 2-22 every 28-day cycles for upto 18 cycles
16166708|NCT01650701|Drug|Rituximab - CHOP|six cycles of R-CHOP in 21 day cycles followed by two 21 day cycles of 375 mg/m2 rituximab; and 7 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles
16166709|NCT01650701|Drug|Rituximab - CVP|eight cycles of R-CVP in 21 day cycles; and 7 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles,
16166710|NCT01650701|Drug|Rituximab - Bendamustine|six cycles of R-B in 28 day cycles and 8 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.
16166711|NCT01650675|Behavioral|WIDUS computer-delivered, indirect brief intervention|A single 20-minute interactive computer-delivered intervention designed to promote motivation to change drug use and risky sexual behavior, if any, without presuming those risks to be specifically present.
16166712|NCT01650675|Behavioral|Nutrition time control/placebo intervention|This time-control intervention, designed in part to help promote RA blinding as to participant condition, focuses on proper infant nutrition using a computer-delivered, interactive format and videos.
16166713|NCT01650662|Drug|Cyclosporine A|In the CsA group, at least 5 min before balloon inflation and stenting, patients will receive an intravenous bolus injection of 2.5 mg/kg of CsA. In the control group, patients will receive only recommended treatments. CsA will be dissolved in normal NaCl 0.9% solution (final concentration 25 mg/ml) and injected slowly (over 20-30 seconds) via a catheter positioned in an antecubital vein at least 5 min before PCI, to allow for distribution of the drug.
16166714|NCT01650649|Drug|Lofexidine HCl|Lofexidine HCl 0.2 mg tablets titrated in ascending doses of 0.2 mg (1 tablet) QID starting at 0.4 mg (2 tablets) QID [e.g. Day 1 0.4 mg (2 tablets) QID, Day 2 0.6 (3 tablets)QID, etc] as described in the treatment arm. Option to down-titrate to 0.2 mg (1 tablet) QID if 0.4 mg (2 tablets) QID dose not initially tolerated.
16166715|NCT01650649|Drug|Lofexidine-matching sugar pill|Lofexidine-matching sugar pill tablets titrated in ascending doses of 1 tablet starting at 2 tablets QID (e.g. Day 1 2 tablets QID, Day 2 3 tablets QID, etc)as described in the treatment arm. Option to down-titrate to 1 tablet QID if 2 tablets not initially tolerated.
16166716|NCT01650636|Behavioral|Patient-Partner Videotelephone-delivered Health Information (PP-T-HI)|Ten (10) 90-min sessions of Health Information delivered via videophones
16166717|NCT01650636|Behavioral|Patient-Partner Videotelephone-delivered Cognitive Behavioral Stress Management intervention (PP-T-CBSM)|Ten (10) 90-min sessions of T-PP-CBSM
16166718|NCT01650623|Behavioral|Gait training executive functions tasks|The training will consist of 10 sessions, two times per week for five weeks, and consists of 30 minutes of global exercises that involves stretching, muscle strengthen and axial mobility exercises, and another 30 minutes of gait training in a dual-task condition associated with distracting tasks that require handling of the main executive functions: volition, self-awareness, planning, response inhibition, response monitoring and attention.
16166719|NCT01650623|Behavioral|Gait training alone|The training will consist of 10 sessions, two times per week for five weeks, and consists of 30 minutes of global exercises that involves stretching, muscle strengthen and axial mobility exercises, and another 30 minutes of gait training alone, without other tasks.
16166720|NCT01650610|Behavioral|Gait training executive functions tasks|The training will consist of 10 sessions, two times per week for five weeks, and consists of 30 minutes of global exercises that involves stretching, muscle strengthen and axial mobility exercises, and another 30 minutes of gait training in a dual-task condition associated with distracting tasks that require handling of the main executive functions: volition, self-awareness, planning, response inhibition, response monitoring and attention.
16166721|NCT01650597|Drug|JNJ-42165279 2.5 - 500 mg oral|Type=exact number, unit=mg, numbers=2.5, 10, 30, 100, 250 and 500, form=suspension, route=oral use. One single dose administered orally.
16166722|NCT01650597|Drug|Placebo|Type=exact number, unit=mg, form=solution, route=oral use. One single dose administered orally.
16166723|NCT01650597|Drug|JNJ-42165279 100 mg oral|Type=exact number, unit=mg, form=solution, route=oral use. One single dose administered orally.
16319685|NCT00502060|Drug|AZD2171|
16166728|NCT01650545|Drug|Liposomal aerosol cyclosporine|inhaled form of immune suppression
16166729|NCT01650545|Other|standard immune suppression, oral|"conventional drug
~Conventrional oral immune suppression as standard of care thus consists of tacrolimus, mycophenolate mofetil prednisone and rapamycin"
16166730|NCT01650532|Behavioral|Yoga Condition|Classes lasting one hour, held 3 times per week for 8 weeks.
16166731|NCT01650532|Behavioral|Stretching Condition|Classes lasting one hour, held 3 times per week for 8 weeks.
16166732|NCT01650519|Drug|IV ibuprofen|800 mg intravenous ibuprofen administered intravenously over 10 minutes.
16166733|NCT01650519|Drug|IV ketorolac|30 mg ketorolac for patients < 65 years of age (15 mg ketorolac for patients > 65 years of age) administered intravenously over no less than 15 seconds
16166734|NCT01650506|Drug|Metformin|Due to frequent GI upset in patients starting metformin the dose will be titrated up to the assigned dose level. The first metformin dose level will be 850 mg twice daily and be escalated to its maximum FDA approved dose of 850 mg three times daily. Dose escalation will follow the standard 3 + 3 design. Dose limiting toxicities will be determined during the first 5 weeks of therapy.
16166735|NCT01650506|Drug|Erlotinib|Erlotinib dosing will start and remain at 150 mg daily.
16166736|NCT01650493|Device|Clinpro 5000|Dentrifice containing 950ppm fluoride
16166737|NCT01650493|Device|MI Paste Plus|Dentrifice containing 950ppm fluoride
16166738|NCT01650493|Device|Tom's of Maine|Dentrifice that is fluoride free
16166739|NCT01650480|Other|HELP-COPD action plan|The trial specialist nurse trained in palliative aspects of respiratory care will arrange a meeting to suit the patients' clinical condition and convenience. During the meeting the HELP-COPD action plan will be worked through by the patient and study nurse, and any areas of concern will be identified. Based on the findings of the assessment, a range of actions points may be generated. All referrals will be made through the usual channels. Issues that have arisen from the assessment will be clearly recorded on the HELP-COPD action plan and by ensuring that all agencies and the patient have copies of the plan it is hoped that the planned action points will be reviewed and implementation facilitated. The action plan will be reviewed by the study nurse who will contact the patient at 1, 3 and 6 months to check progress with action points.
16166740|NCT01650454|Other|2 night polysomnography|Polysomnography
16166741|NCT01650454|Other|battery of neuropsychological tests|
16166742|NCT01650454|Other|virtual reality test|
16166743|NCT01650454|Other|subjective evaluation of sleep and somnolence|
16166744|NCT01650441|Drug|Beclomethasone dipropionate 100 µg + formoterol fumarate 6 µg|In this trial, patients will take two inhalations of the beclometasone dipropionate 100 µg and formoterol fumarate 6 µg combination therapy (Foster®) using a Dry Powder Inhaler (NEXThaler®) device in the morning and two inhalations in the evening, for a total of 4 inhalations a day (total daily dose: BDP 400 µg / FF 24 µg).
16166745|NCT01650441|Radiation|CT thorax|"CT scan of the thorax will be performed at 2 time points: baseline and after 6 months of treatment.
~The CT scan will be performed with low dose radiation using the multi-slice CT scan. Scanning will be performed at Functional Residual Capacity and Total Lung Capacity (2 times 8 sec). The lung volumes will be controlled using adapted spirometry during the CT procedure. The radiation dose will be reduced by reduction of the tube current and voltage. These settings depend on the patients' weight (1mAs/kg). In addition to this there will be an increase in noise factor to further reduce the radiation dose."
16166746|NCT01650428|Biological|Bevacizumab|5 mg/kg, IV (in the vein) over 30-90 minutes, on day 1 of each 2 weekly cycles. Number of cycles: 1-5 (bevacizumab should not be administered during cycle 6).
16166747|NCT01650428|Drug|Irinotecan|165 mg/m2 IV (intravenous) over 1 hour on day 1 of two weekly cycle. Number of cycles: 1-6
16166748|NCT01650428|Drug|Oxaliplatin|165 mg/m2 IV (intravenous) over 1 hour on day 1 of two weekly cycle. Number of cycles: 1-6
16166749|NCT01650428|Drug|5-Fluorouracil|3200 mg/m2 IV (intravenous), continuous infusion over 48 hours starting on day 1 of two weekly cycle. Number of cycles: 1-6
16166750|NCT01650415|Drug|Erythropoietin|twice a week for 1 month
16166751|NCT01650415|Drug|Placebo erythropoietin|twice a week for 1 month
16166752|NCT01650402|Other|Anti-hypertensive therapy to SBP 130 mm Hg|Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 130 mm Hg
16166753|NCT01650402|Other|Anti-hypertensive therapy to SBP 145 mm Hg|Anti-hypertensive therapy to achieve 24 hour systolic blood pressure less than or equal to 145 mm Hg
16166754|NCT01650389|Biological|MVA85A|
16166755|NCT01650389|Biological|Candin|
16166756|NCT01650389|Biological|BCG Vaccine SSI|"All infants who test negative by HIV PCR will receive BCG vaccination at 8 weeks of age.
~Infants who test positive by HIV PCR will not receive BCG vaccination."
16166757|NCT01650376|Drug|Olaparib|Olaparib will be administered orally on Days 1, 2, and 3 of each week until DLT or disease progression. A minimum of 3 patients will be enrolled into each cohort. The anticipated dose escalation sequence of olaparib is 50, 100, 150 and 200 mg, taken twice a day will be used.
16166758|NCT01650376|Drug|Carboplatin|AUC 2 weekly for 3 weeks of a 4 week cycle. For patients who experience a complete response, the carboplatin and paclitaxel will be discontinued and olaparib monotherapy (400 mg, taken twice a day) will continue until disease progression and as long as the investigator feels they are benefiting from the treatment.
16166759|NCT01650376|Drug|Paclitaxel|60mg/m2 weekly for 3 weeks of a 4 week cycle. For patients who experience a complete response, the carboplatin and paclitaxel will be discontinued and olaparib monotherapy (400 mg, taken twice a day) will continue until disease progression and as long as the investigator feels they are benefiting from the treatment.
16166760|NCT01650363|Other|Acupuncture, homeopathy, osteopathy- and reflexology|a combination of the above mentioned treatments
16166761|NCT01650363|Drug|Homeopathic placebo medication|2-3 mm small spheric suger pils
16166762|NCT01650350|Drug|Naltrexone|
16166763|NCT01650337|Other|Smartphone Application|Smartphone application to help monitor caloric intake and expenditure
16166764|NCT01650324|Drug|DBPR108|DBPR108 capsules in four doses beginning at 25 mg and rising to 600 mg.
16166765|NCT01650324|Drug|matching placebo|Matching placebo capsules in four doses beginning at 25 mg and rising to 600 mg.
16166766|NCT01650298|Other|Drug (Direct thrombin or Factor Xa inhibitor)|Patient will stop or restart drug per cardiac device information (AT/AF diagnostics for prespecified AT/AF episode duration per day and total burden).
16166767|NCT01650285|Drug|Cabazitaxel|"Dose Level Day 1, 22, 43
~5.0 mg/m2
~10.0 mg/m2
~15.0 mg/m2
~20.0 mg/m2"
16166768|NCT01650272|Drug|5% MInoxidil milky lotion|Patient receive 5% MInoxidil milky lotion (Butylene glycol solvent)
16166769|NCT01650272|Drug|5% Minoxidil solution|Patient receive 5% Minoxidil solution (Propylene glycol solvent )
16166770|NCT01650259|Drug|OAD|OAD except Trazenta tablets
16166771|NCT01650259|Drug|Trazenta|Linagliptin
16166772|NCT01650246|Drug|lesinurad|Tablets, 400 mg QD
16166773|NCT01650233|Behavioral|Mindfulness-based stress reduction|
16166774|NCT01650207|Procedure|acupuncture|"All participants were received regular rehabilitation program, and received different interventions.
~treatment frequency: 20 minutes per session, once daily, 5 times a week for 2 weeks"
16166775|NCT01650207|Procedure|TENS|
16166776|NCT01650207|Procedure|sham acupuncture|
16166777|NCT01650194|Drug|enzalutamide|Participants received 160 mg of enzalutamide orally once daily (4 capsules, 40 mg each).
16166778|NCT01650194|Drug|abiraterone acetate|Participants received 1000 mg of abiraterone acetate orally once daily (4 tablets, 250 mg each).
16166779|NCT01650194|Drug|prednisone|Participants received 5 mg of prednisone orally twice daily (2 tablets, 5 mg each).
16166780|NCT01650181|Drug|Metformin|Patients with Steatohepatitis treated with diet, exercise and metformin
16166781|NCT01650181|Dietary Supplement|Siliphos+ Selenium - Methionine + Alpha Lipoic Acid|Patients with Steatohepatitis treated with diet, exercise, metformin and Siliphos (140mg) + Selenium (15 mcg) - Methionine (3mg) + Alpha Lipoic Acid (200mg), two tablets BID
16166782|NCT01650181|Dietary Supplement|Siliphos+ Selenium - Methionine + Alpha Lipoic Acid|Patients with fatty liver treated with diet, exercise, metformin and Siliphos (140mg) + Selenium (15 mcg) - Methionine (3mg) + Alpha Lipoic Acid (200mg), two tablets BID
16166783|NCT01650181|Drug|Metformin|Patients with fatty liver treated with diet, exercise and metformin
16166784|NCT01650155|Drug|BI 1005273 s.c.|injection
16166785|NCT01650155|Drug|BI 105273 i.v. Placebo|infusion
16166786|NCT01650155|Drug|BI 1005273 s.c. Placebo|injection
16166787|NCT01650155|Drug|BI 1005273 i.v.|infusion
16166788|NCT01650142|Other|No intervention|No intervention
16166789|NCT01650129|Drug|biphasic insulin aspart 50|Administered subcutaneously (s.c., under the skin) twice daily for 24 weeks. Injected immediately before breakfast and dinner
16166790|NCT01650129|Drug|biphasic human insulin 50|Administered subcutaneously (s.c., under the skin) twice daily for 24 weeks. Injected 30 minutes before breakfast and dinner
16166791|NCT01650090|Drug|Inhaled Lipid Cisplatin (ILC)|ILC is provided as cisplatin in a lipid complex suspended in a saline solution. Every two weeks, the patient will receive 36 mg/m2 (measured as concentration of cisplatin) of ILC via nebulization. Treatment may continue for up to 1 year.
16166792|NCT01650051|Drug|Placebo of Phenazopyridine Hydrochloride Tables, USP 200 mg|"Deep brown maroon colored, film coated round biconvex tablet debossed 'AN obve '2' on one side and plain on the other side."
16166793|NCT01650051|Drug|Phenazopyridine Hydrochloride Tables, USP 200 mg|"Deep brown maroon colored, film coated round biconvex tablet debossed 'AN obve '2' on one side and plain on the other side."
16166794|NCT01650038|Other|treatment with faecal transplantation (donor faeces)|faecal transplantation
16166795|NCT01650038|Other|treatment with faecal transplantation (own faeces)|faecal transplantation
16166796|NCT01650025|Dietary Supplement|VSL#3 active probiotic|
16166797|NCT01650025|Other|VSL#3 placebo|
16166798|NCT01650012|Drug|eplerenone|target 50 mg per day titrated down for hyperkalemia or hypotension
16166799|NCT01650012|Drug|Placebo|Placebo
16166800|NCT01649999|Drug|peficitinib|oral
16166801|NCT01649999|Drug|Placebo|oral
16166802|NCT01649986|Behavioral|Non-pharmacologic intervention|Diet and physical exercise
16166803|NCT01649986|Drug|Nutraceuticals (Armolipid Plus)|Patients assigned by their own general practitioner to receive nutraceuticals, along with non-pharmacologic intervention and prevention strategies, will have for 1 year also 1 capsule/day containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg,
16166804|NCT01649960|Drug|Rapamycin|Oral tablets were given in the dose of 0.5mg, 1mg, or 2mg once a day. This was a pilot study and the serum rapamycin levels were kept below 6ng/ml.
16166805|NCT01649947|Drug|Paclitaxel|"Paclitaxel will be given at a dose of 200 mg/m2(by IV over 3 hours on Day 1). Cycles every 3 weeks for 4-6 Cycles.
~Prior to receiving paclitaxel, all patients will receive the following premedication:
~Dexamethasone 20 mg po 12 and 6 hours prior to paclitaxel infusion (patients may be treated with dexamethasone 20 mg iv < 1 hour prior to infusion with paclitaxel if the patient did not take the oral dexamethasone)
~Diphenydramine 50 mg iv (or equivalent) < 1 hour prior to paclitaxel infusion
~Ranitidine 50 mg iv < 1 hour prior to paclitaxel infusion (alternatively other H2-blockers may be used)"
16166806|NCT01649947|Drug|Carboplatin|Carboplatin will be given at AUC = 6 by IV over 15-30 minutes on Day 1 immediately following paclitaxel. Cycles every 3 weeks for 4-6 Cycles.
16166807|NCT01649947|Drug|Hydroxychloroquine|Hydroxychloroquine will be given as a flat dose of 200 mg orally BID (total daily dose of 400 mg). Cycles every 3 weeks for 4-6 Cycles.
16166808|NCT01649947|Drug|Bevacizumab|"Cohort 1 only:
~Bevacizumab will be given by IV on Day 1 of each 21-day cycle at a dose of 15 mg/kg. Cycles every 3 weeks for 4-6 Cycles."
16166809|NCT01649934|Behavioral|Implementation Intention|Implementation Intentions are a series of what/when/where statements that a participant will make to create automatic cues to complete a behaviorally advantageous action.
16166810|NCT01649934|Behavioral|Contact Clinic|Participants will be asked to sign a form indicating their need to contact the recommended clinics to make their appointments.
16166811|NCT01649921|Drug|Interferon-gamma, Recombinant|Interferon-gamma (Immukine, Boehringer-Ingelheim, Alkmaar, the Netherlands), 100mcg subcutaneously, on days 0-2-4-7-9-11. Interferon-gamma treatment will be initiated when the noradrenalin dose is reduced to 50% of maximum dose, ensuring that the sepsis-induced pro-inflammatory phase has passed
16166812|NCT01649921|Other|Saline 0.9%|subcutaneous administration on days 0, 2, 4, 7, 9, and 11.
16166813|NCT01649895|Drug|D-Cycloserine|Predicted to enhance the effects of exposure in internet-based cognitive-behaviour therapy
16166814|NCT01649895|Drug|Placebo|Placebo pills as adjunct to internet-based cognitive-behaviour therapy
16319686|NCT00502060|Drug|ZD1839|
16166815|NCT01649882|Procedure|US ETT (ultrasound endotracheal tube)|Subjects will have a brief (< 15 minutes) ultrasound exam of the neck after intubation. The cuff of the endotracheal tube as well as the aortic arch will be identified. The distance between the two structures will be measured and recorded.
16166816|NCT01649869|Other|Placebo|Simple Syrup as 60-90% sucrose in purified water: given orally twice a day for 6 weeks
16166817|NCT01649869|Drug|Valganciclovir|Valcyte (valganciclovir hydrochloride) 50 mg of valganciclovir free base per 1 mL, oral solution: given at 16.0 mg/kg, twice a day for 6 weeks.
16166818|NCT01649856|Drug|CHOP|CHOP chemotherapy: cyclophosphamide, doxorubicin, vincristine, prednisone/prednisolone; 6 or 8 cycles
16166819|NCT01649856|Drug|rituximab [MabThera/Rituxan]|The first rituximab dose will be administered intravenously on Day of Cycle 1 at a dose of 375 mg/m2. Subsequent doses of 1400 mg are administered subcutaneously on Day 1 of each cycle, for a further 7 cycles
16166820|NCT01649856|Drug|rituximab [MabThera/Rituxan]|375 mg/m2 intravenously on Day 1 of each cycle, 8 cycles
16166821|NCT01649843|Procedure|POEM|Peroral endoscopic myotomy (POEM) has recently been described as a new minimally invasive endoscopic myotomy technique intending a permanent cure from primary achalasia in some centers.
16166822|NCT01649830|Radiation|Radiotherapy|External beam radiation: 54.0 Gy in 27 - 30 fractions over 6 - 7 weeks.
16166823|NCT01649830|Drug|Temozolomide|dosed at 200 mg/m2 (150 mg/m2 for the first cycle) daily for 5 consecutive days, repeated every 28 days.
16166824|NCT01649804|Drug|tocilizumab [RoActemra/Actemra]|8 mg/kg intravenously every 4 weeks for 104 weeks
16166825|NCT01649791|Drug|lenalidomide|Given orally
16166826|NCT01649791|Other|laboratory biomarker analysis|Correlative study
16166827|NCT01649791|Procedure|lymph node biopsy|Correlative study
16166828|NCT01649791|Procedure|bone marrow aspiration|Correlative study
16166829|NCT01649791|Other|pharmacological study|Correlative study
16166830|NCT01649791|Other|flow cytometry|Correlative study
16166831|NCT01649778|Drug|Pazopanib|Prospective Observational study collecting real world data on Pazopanib in patients with advanced or metastatic Renal Cell Carcinoma. Study is considered non-interventional, no drug will be provided. No study visits or procedures are mandated per protocol.
16166832|NCT01649765|Drug|belimumab 10mg/kg|belimumab 10mg/kg IV monthly
16166833|NCT01649765|Other|placebo|Normal Saline 250 ml
16166834|NCT01649752|Biological|Differentiated stem cells to endometrium is deposited in the uterine cavity through an IUI catheter|
16166835|NCT01649752|Biological|Undifferentiated MSC is deposited in the uterine cavity through an IUI catheter.|
16166836|NCT01649739|Drug|Levitra|There is 2 dosage:10mg Twice daily and 20mg Twice daily
16166837|NCT01649726|Procedure|Apnea test - control|
16166838|NCT01649726|Procedure|Apnea test - CPAP|
16166839|NCT01649713|Drug|Fluval AB vaccination|Vaccination with Fluval AB suspension for injection
16166840|NCT01649700|Biological|autologous adipose-derived mesenchymal stem cells|Patients will receive five infusions, one month apart, each comprising 5-7x10^7 cells of autologous adipose-derived mesenchymal stem cells.
16166841|NCT01649687|Biological|Allogeneic adult adipose-derived mesenchymal stem cells|Patients will receive intravenously one dose of 5-7x10^7 cells of allogeneic adipose-derived mesenchymal stem cells
16166842|NCT01649674|Drug|polyethylene glycole (PEG) solution|
16166843|NCT01649674|Drug|sodium picosulphate and magnesium citrate solution|
16166844|NCT01649661|Behavioral|questionnaire|
16166845|NCT01649648|Biological|Autologous cord blood|Baby's own umbilical cord blood
16166846|NCT01649635|Drug|CABAZITAXEL (XRP6258)|Pharmaceutical form: solution Route of administration: intravenous
16166847|NCT01649635|Drug|Prednisone|Pharmaceutical form: tablet Route of administration: oral
16166848|NCT01649635|Drug|Ciprofloxacin|Pharmaceutical form: tablet Route of administration: oral
16166849|NCT01649635|Drug|G-CSF (Granulocyte colony-stimulating factor)|Pharmaceutical form: solution Route of administration: subcutaneous
16166850|NCT01649622|Drug|Bendamustine|75 mg/m2 by vein twice daily for four days (Days 1-4). Cycles may be repeated every 3 to 10 weeks based on leukemia response for up to 12 courses.
16166851|NCT01649609|Drug|Tacrolimus|Reduction of standard immunosuppression - The standard of care immunosuppression treatment commonly used for renal transplant patients
16166852|NCT01649609|Drug|Mycophenolate acid|Myfortic or CellCept - The standard of care immunosuppression treatment most commonly used for renal transplant patients
16166853|NCT01649609|Drug|Sirolimus|mTOR Substitution - Replacing tacrolimus (a calcineurin inhibitor) with sirolimus (an mTOR inhibitor) along with reduction of mycophenolic acid
16166854|NCT01649596|Device|Warming Gown|Forced air warming Gown and portable warming unit that follows patient from pre-operative through surgery and into post-operative recovery.
16166855|NCT01649596|Other|Standard of care warming|The intervention is standard of care, placing warm blankets on the patient at time of pre operative preparation through the procedure and into recovery.
16166856|NCT01649583|Device|Jaw Dynasplint System|Patients on the intervention arm will wear the Jaw Dynasplint® System for 30 minutes, 3 times per day each day during the cancer treatment period and for the first 3 months after primary or adjuvant based-radiation treatment (recovery period) is completed. Patients will maintain a daily patient log indicating the amount of time they used the Jaw Dynasplint® System.
16166857|NCT01649570|Drug|insulin aspart|Administrated subcutaneously (s.c., under the skin) three times a day before each meal for 24 weeks
16166858|NCT01649557|Drug|OPC-34712|oral administered once daily
16166859|NCT01649544|Device|EPICOR|Intraoperatively, in addition to the usual gesture, it will be conducted a systematic exclusion-ligation of the left atrium and the establishment of electrodes atrial and ventricular pacing. The right pulmonary veins are isolated by dissection of the inter-atrial groove and application of the probe by biting on the atrial tissue, the procedure is identical on the left after dissection of the area between the left pulmonary artery and pulmonary veins. The use of ultrasound application will require 10 minutes to around the pulmonary veins using a multi-electrode probe set to deliver an output pulse from 15 to 100 Watts at a frequency from 3.5 to 4.6 MHz. Using EPICOR extends the operating time of 15 minutes.
16166860|NCT01649544|Drug|Amiodarone|
16166861|NCT01649531|Procedure|1 Implant|
16166862|NCT01649531|Procedure|2 Implants|
16166863|NCT01649505|Drug|fibrin sealant (Beriplast P, TISSEEL VH)|Applied topically
16166864|NCT01649505|Procedure|breast reconstruction|Undergo sharp dissection technique
16166865|NCT01649505|Procedure|breast reconstruction|Undergo electrocoagulation dissection technique
16166866|NCT01649492|Dietary Supplement|pineapple juice (Carrefour n°1) 500 ml/day 5 days|
16166867|NCT01649479|Biological|Antiphospholipid antibody tests|Each patient will be tested for antiphospholipid antibodies.
16166868|NCT01649479|Biological|Thrombophilia bloodwork|"Bloodwork will be drawn up for:
~antithrombin, protein C, protein S
~Factor V Leiden polymorphisms (F5 1691A)
~prothrombin 20210A gene polymorphism (F2 20210A)
~JAK2 617F Mutation
~Homocysteine
~Factor VIII"
16166869|NCT01649479|Other|Psychiatric evaluation|During this consultation, the Mini International Neuropsychiatric Interview will be used to screen for psychiatric symptoms. Should the latter be detected, a further consult with a psychiatrist or a psychologist will be organized; this second consult will include the Mood Disorder Questionnaire (MDQ), the Beck Depression Inventory (BDI), the Inventory for Depressive Symptomatology - Clinician (IDS-C) and the Structured Clinical Interview for Disorders (SCID, DSM-IV).
16166870|NCT01649466|Drug|LAF237|Vildagliptin will be used as commercially available tablets of 50mg.
16166871|NCT01649466|Drug|Protaphane|Protaphane will be used as commercially available injection pens
16166872|NCT01649453|Device|Pathwork® Tissue of Origin Test|
16166873|NCT01649427|Drug|Prograf|Prograf® capsules were supplied as capsules of 0.5 mg, 1 mg and 1.5 mg dose strengths.
16166874|NCT01649427|Drug|Tacrolimus Hexal|"Tacrolimus Hexal® capsules were supplied to the investigators at dose strengths of 0.5 mg,
~1 mg and 1.5 mg."
16166875|NCT01649401|Device|Standard nebulizer|"Nebulizer sessions for the patients will be administerd using our standard nebulizer: Micro Mist, ref 41894, Hudson RCI, distributed by Téléflex Médical."
16166876|NCT01649401|Device|PARI LC Sprint Sp nebulizer|"Nebulizer sessions for the patients will be administerd using the PARI LC Sprint Sp nebulizer.
~Manufacturer: PARI GmbH Germany"
16166877|NCT01649388|Biological|Enriched Hematopoetic Stem Cell Infusion|Enriched Hematopoetic Stem Cell Infusion
16166878|NCT01649375|Drug|Secukinumab (75 mg)|Secukinumab 75 mg s.c.
16166879|NCT01649375|Drug|Placebo|Placebo
16166880|NCT01649375|Drug|Secukinumab (150 mg)|Secukinumab 150 mg s.c.
16166881|NCT01649362|Other|prefeeding oral stimulation program|"The intervention will start at 32 weeks PMA in a medically stable infant feed by gavage feeding for the infants born before 32 weeks' gestational age, and, as soon as clinical stability is acquired, for the infants born after 32 weeks.
~The prefeeding oral stimulation program consists of a 15-minute stimulation program, delivered by the nurse or the medical staff, according to the stimulation program proposed by Fucile, Gisel and Lau. The program is going to be administered once a day for 14 consecutive days (for infants born before 32 weeks' gestational age), 15 to 30 minutes before a tube feeding. In infants born after 32 weeks' gestational age, stimulation program is going to be stopped when the infant attains 3 complete oral feedings by day."
16166882|NCT01649349|Device|two-piece nasogastric tube|one week period
16166883|NCT01649336|Drug|MEK162, MEK inhibitor; oral|multiple dose, escalating
16166884|NCT01649336|Drug|Paclitaxel, mitotic inhibitor; intravenous|multiple dose, single schedule
16166885|NCT01649310|Other|whole body vibration|Exercises on the platform will be made in semi-squat position, static. In the first month training will be held for 10 minutes for the exercises on the platform, 30 seconds of vibration of low intensity, interspersed with rest 60 seconds while standing beside the platform. In the second month training will be held for 15 minutes, lasting 60 seconds of vibration and 30 seconds of rest in standing beside the platform. For the first two weeks training will have low intensity and the last two weeks training will have higher vibration. In the third month, training will be held for 20 minutes, 60 seconds of vibration and 30 seconds of rest while standing beside the platform. The intensity of the vibration will be high.
16166886|NCT01649297|Drug|Placebo|Patients receive placebo matching empagliflozin (low dose qd)
16166887|NCT01649297|Drug|Placebo|Patients receive placebo matching empagliflozin (low dose bid)
16166888|NCT01649297|Drug|Placebo|Patients receive placebo matching Empagliflozin (high dose qd)
16166889|NCT01649297|Drug|Placebo|Patients receive placebo matching Empagliflozin (high dose qd)
16166890|NCT01649297|Drug|Placebo|Patients receive placebo matching Empagliflozin (high dose qd)
16166891|NCT01649297|Drug|empagliflozin (low dose qd)|Patients receive Empagliflozin low dose once daily
16166892|NCT01649297|Drug|Placebo|Patients receive placebo matching empagliflozin (low dose qd)
16166893|NCT01649297|Drug|Placebo|Patients receive placebo matching empagliflozin (low dose bid)
16166894|NCT01649297|Drug|Placebo|Patients receive placebo matching Empagliflozin (high dose bid)
16166895|NCT01649297|Drug|Placebo|Patients receive placebo matching Empagliflozin (high dose bid)
16166896|NCT01649297|Drug|Placebo|Patients receive placebo matching empagliflozin (low dose qd)
16166897|NCT01649297|Drug|Placebo|Patients receive placebo matching empagliflozin (low dose bid)
16166898|NCT01649297|Drug|Placebo|Patients receive placebo matching Empagliflozin (high dose bid)
16166899|NCT01649297|Drug|Placebo|Patients receive placebo matching empagliflozin (low dose qd)
16166900|NCT01649297|Drug|Placebo|Patients receive placebo matching empagliflozin (low dose bid)
16166901|NCT01649297|Drug|Placebo|Patients receive placebo matching Empagliflozin (high dose bid)
16166902|NCT01649297|Drug|Empagliflozin (high dose qd)|Patients receive Empagliflozin high dose once daily
16166903|NCT01649297|Drug|empagliflozin (high dose bid)|Patients receive Empagliflozin high dose split twice daily
16166904|NCT01649297|Drug|Placebo|Patients receive placebo matching Empagliflozin (high dose qd)
16166905|NCT01649297|Drug|empagliflozin (low dose bid)|Patients receive Empagliflozin low dose split twice daily
16166906|NCT01649284|Drug|afatinib|40, 30, and 20 mg film-coated tablets
16166907|NCT01649271|Drug|Herceptin|3-weekly
16166908|NCT01649271|Drug|afatinib|at MTD level
16166909|NCT01649271|Drug|trastuzumab|3-weekly
16166910|NCT01649271|Drug|Herceptin|weekly
16166911|NCT01649271|Drug|afatinib|at MTD level
16166912|NCT01649271|Drug|afatinib|escalating dose
16166913|NCT01649258|Drug|granisetron transdermal system|Given granisetron transdermal system patch
16166916|NCT01649245|Drug|Reiferon retard|Eligible subjects will be treated with Reiferon Retard® 160 µg weekly by subcutaneous injection for 48 weeks, together with weight-based oral ribavirin (1200 mg/day if body weight is >75 kg and 1000 mg/day if body weight is ≤ 75 kg) in divided doses.
16166917|NCT01649232|Device|Active tDCS|tDCS applied to left dorsolateral prefrontal scalp area through a saline-soaked pair of surface sponge electrodes (35 cm2). The anode electrode was placed over F3 (based on the 10-20 International EEG System) of each subject. The cathode was placed over the contralateral mastoid area. A constant current of 1.1 mA was applied for 25 min/day (administered for 12 alternated days).
16166918|NCT01649219|Behavioral|Exercise|
16166919|NCT01649206|Procedure|Percutaneous Radiofrequency Thermal Ablation|Percutaneous Radiofrequency Thermal Ablation (RTA) by using a RITA© StarBurst Talon needle (RITA Medical Systems, Fremont, CA). RTA is performed in each patient at Time 0.
16166920|NCT01649193|Other|Pulmonary rehabilitation|An eight week out-patient based programme consisting of twice weekly supervised exercise and educational sessions
16166921|NCT01649180|Drug|Axitinib|Axitinib 5 mg orally with food every 12 hours. One cycle=28 days.
16166922|NCT01649154|Procedure|Total Thyroidectomy with cut and tie technique vs Total Thyroidectomy with Ligasure Small-JAW vs Total Thyroidectomy with Harmonic Focus|
16166923|NCT01649141|Behavioral|Trauma-Focused Cognitive Behavioral Therapy|Trauma-Focused Cognitive Behavioral Therapy (TF-CBT) is a structured, 12-16 session outpatient intervention originally developed to treat Posttraumatic Stress Disorder (PTSD) and related emotional and behavioral difficulties in youth with a history of child sexual abuse. TF-CBT's eight components are delivered in 90-minute weekly sessions split evenly between children and their parents. These components are summarized by the acronym PRACTICE including: psychoeducation and parenting skills (P), relaxation (R), affective expression and regulation (A), cognitive coping (C), trauma narrative development and processing (T), in vivo gradual exposure (I), conjoint parent/child sessions (C) and enhancing safety and future development (E).
16166924|NCT01649115|Other|Healthy Lifestyles Passport|The participants will be provided with the Healthy Lifestyles Passport, and with each corresponding page, there will be an activity. Each participant in the Healthy Lifestyles Passport arm will receive the same education.
16166925|NCT01649102|Device|Tunneled Cuffed Catheter (Palindroom, Hemoglide Bard)|"A tunneled cuffed catheter is inserted, randomization between:
~Palindroom
~Hemoglide Bard"
16166926|NCT01649089|Procedure|Conization|Undergo cone biopsy
16166927|NCT01649089|Other|Quality-of-Life Assessment|Ancillary studies
16166928|NCT01649089|Other|Questionnaire Administration|Ancillary studies
16166929|NCT01649089|Procedure|Therapeutic Conventional Surgery|Undergo hysterectomy
16166930|NCT01649089|Procedure|Therapeutic Lymphadenectomy|Undergo lymphadenectomy
16166931|NCT01649050|Drug|BGG492|
16166932|NCT01649050|Drug|Placebo|
16166933|NCT01649037|Drug|nor adrenaline and terlipressin|"IV bolus terlipressin at the dose of 0.5 to 1 mg every 6 hours with the maximum daily cumulative dose of 4 mg/day.
~Continuous IV infusion of NA starting at 0.5 mg/h with doubling of dose after every 4 hours in case of no response.[ No response defined as MAP < 10, or 4 hr Urine output < 200 ml] with maximum dose upto 3 mg/h."
16166934|NCT01649037|Drug|step up terlipressin therapy|IV bolus terlipressin starting at 1.5 mg every 6 hours with increase in dose by 0.5 mg/6 hours in case of no response [< 25% decrease in s.creatinine] after every 48 hours. Maximum daily cumulative dose of 12 mg/day.
16166935|NCT01649024|Drug|Tremelimumab|Given IV
16166936|NCT01649011|Behavioral|Application of the initial evaluation|Initial evaluation involves the application of the previously spanish validated Rolland Morris Questionnaire and the new spanish Oswestry Disability Index
16166937|NCT01649011|Behavioral|Final application of scales|Application of the previously spanish validated version of the RMQ and the new spanish translation of the ODI 2 weeks after initial evaluation
16166938|NCT01648998|Drug|Fludrocortisone|single dose 500 mg, capsule
16166939|NCT01648998|Drug|Placebo|
16166940|NCT01648985|Other|Diabetes in stroke/TIA|Mostly no intervention. A small Group of the patients recieved Yoga
16166941|NCT01648972|Drug|Gastrografin|
16166942|NCT01648972|Drug|Placebo|
16166943|NCT01648959|Other|EEG Recording|
16166944|NCT01648946|Biological|Red blood cell transfusion|Red blood cell (RBC) transfusion will be given when hemoglobin falls below 9 g/dL since ICU admission until the discharge of intensive care unit. Following administration of 1 RBC unit, a repetition of hemoglobin levels is performed; if a patient's hemoglobin level is 9 g/dL or higher, no additional transfusion is necessary.
16166945|NCT01648946|Biological|Red blood cell transfusion|Red blood cell (RBC) transfusion will be only given when hemoglobin falls below 7 g/dL since ICU admission until the discharge of intensive care unit. Following administration of 1 RBC unit, a repetition of the hematocrit is performed; if a patient's hemoglobin is 7 g/dL or higher, no additional transfusion is necessary.
16166946|NCT01648933|Radiation|Rubidium PET|Myocardial Perfusion Imaging
16166947|NCT01648920|Device|NIOX MINO® Instrument (09-1100)|The NIOX MINO® Instrument (09-1100) is a 10 second test based on exhaled breath measured at a 50 ml/second flow rate.
16166948|NCT01648907|Other|Imaging exams|"Radiological examinations:
~Standard x-ray: they include an x-ray of the cervical, thoracic, and lumbar spine (side-on), of the lumbar spine from the front and an x-ray of the pelvis from the front
~MRI scan: are taken of the cervical, thoracic and lumbar spine and sacroiliac joints.
~Bone densitometry: evaluation of bone densitometry of the lumbar spine and femoral neck.
~Enthesis ultrasound: bilateral evaluation of entheseal insertions for the Achilles tendon, patella tendons and epicondyle tendons.
~Biological tests :
~Genetic test : DNA will be collected at the first visit from all centers. RNA will be collected at the inclusion visit in AP-HP centres only.
~Serum will be collected by all centres at the initial visit, then in M6, M12 and M24 for the first two years of the study, then in M60.
~Urine will be collected by all centres at the initial visit, then in M24 for the first two years of the study, then in M60."
16166949|NCT01648894|Procedure|Surgery after 11 weeks of delay after chemoradiotherapy.|Surgery consists carcinological resection of the rectal cancer with total excision of the mesorectum after 11 weeks of delay after the end of chemoradiotherapy.
16166950|NCT01648894|Procedure|Surgery after 7 weeks of delay after chemoradiotherapy|Surgery consists carcinological resection of the rectal cancer with total excision of the mesorectum after 7 weeks of delay after the end of chemoradiotherapy
16166951|NCT01648881|Radiation|TEP-18FDG for every patient after aortic dissection|"Cover key details of the intervention. Must be sufficiently detailed to distinguish between arms of a study (e.g., comparison of different dosages of drug) and/or among similar interventions (e.g., comparison of multiple implantable cardiac defibrillators). For example, interventions involving drugs may include dosage form, dosage, frequency and duration.
~Example: 50 mg/m2, IV (in the vein) on day 5 of each 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops."
16166952|NCT01648868|Device|Transcranial Magnetic Stimulation (rTMS)|Excitatory effects of Transcranial Magnetic Stimulation (rTMS) applied to the STS in patients with autism.
16166953|NCT01648868|Device|Transcranial Magnetic Stimulation (rTMS)|Inhibitory effects of Transcranial Magnetic Stimulation (rTMS) applied to the STS in healthy controls
16166954|NCT01648855|Other|Biological samples|To measure the levels of sFlt1, angiogenic and antiangiogenic factors at birth in maternal blood, umbilical cord blood and in the amniotic fluid
16166955|NCT01648829|Drug|Atorvastatin|Patients will receive randomly atorvastatin (20 mg day) for 30 days
16166956|NCT01648829|Drug|Pitavastatin|Patients will receive randomly pitavastatin (4 mg day) for 30 days
16166957|NCT01648790|Drug|Prasugrel ODT1 - Tablet|Administered orally as tablet.
16166958|NCT01648790|Drug|Prasugrel ODT2 - Tablet|Administered orally as tablet.
16166959|NCT01648790|Drug|Prasugrel ODT2 - Suspension|Administered orally as suspension.
16166960|NCT01648777|Device|L bupivacaine|"L-bupivacain solution CHIROCAINE® 5mg/ml, flakon de 20 ml): for the intravenous bolus of 10 ml
~o (CHIROCAINE®1.25mg/ml, 200 mL/unit, 400 ml in the accufusor infused at 8ml/h during 48h00: for infusion during 48h00"
16166961|NCT01648777|Drug|placebo|"Isotonic NaCl solution (9°/00) solution: for the intravenous bolus of 10 ml
~Isotonic NaCl solution (9°/00) solution, 400 ml in the accufusor infused at 8ml/h during 48h00: for infusion during 48h00"
16166962|NCT01648764|Drug|LY2334737|Administered orally
16166963|NCT01648751|Drug|Vaginal estrogen|1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter
16166964|NCT01648751|Drug|Placebo|1 gram vaginally for 7 days, followed by 1 gram vaginally twice weekly thereafter
16166965|NCT01648738|Other|Spa therapy, exercise and educational therapy|During 5 days: Spa therapy (2 hours/day), exercises (30 min/day), educational therapy (45 min/day) including education on physical activities, work, and pain management
16166966|NCT01648738|Other|Usual care|Information, counseling, treatment usually provided for sub-acute and chronic low back pain and the back book
16166967|NCT01648725|Procedure|Hypnosis|A short preanesthetic hypnosis before induction of anesthesia
16166968|NCT01648725|Procedure|usual care|Standard care before induction of anesthesia
16166969|NCT01648712|Device|Balance surface, Carmeda heparin-coated surface|"This study compares the influence of a Balance - coated CPB system in pediatric use versus the Carmeda TM heparin-coated system in platelet function preservation and hemostatic activation.
~Balance arm group recieved like intervention a Balance circuit"
16166970|NCT01648712|Device|non -heparin extracorporeal pediatric device for operation|The carmeda arm group received like intervention the Carmeda circuit
16166971|NCT01648699|Drug|Osmotic Release Oral System (OROS) hydromorphone|OROS Hydromorphone will be administered as either 8, 12, 16, 20, 24, 32, 36 or 40 mg oral tablet once daily in the morning. For all participants, 24-hour stable opioid dose (of either morphine or oxycodone) will be converted to a single daily dose of OROS hydromorphone using standard equi-analgesic ratios and dose will be increased if needed, but not more than 40 mg and not more frequently than every two days. The study drug will be administered up to 28 days.
16166972|NCT01648686|Procedure|Dental extraction|3 dental radiographies realised immediately, then 30 days, then 90 days after dental extraction
16166973|NCT01648660|Dietary Supplement|Lutein/ Zeaxanthin + Omega- 3- Fatty Acids|capsule with Lutein, Zeaxanthin, Omega-3-FA for two years
16166974|NCT01648634|Drug|Nebivolol|A 1.25mg-test dose will be administrated to assess the treatment tolerance before randomization. A forced titration of nebivolol will be performed with 2 weeks periods. Full dose of nebivolol is 5mg/day (7.5mg/day for patients whose weight is>60kg)
16166975|NCT01648634|Drug|Placebo|A 1.25mg-test dose of nebivolol will be administrated to assess the treatment tolerance before randomization. A forced titration of placebo will be performed with 2 weeks periods. Full dose of placebo is 5mg/day (7.5mg/day for patients whose weight is>60kg)
16166976|NCT01648621|Behavioral|40 minute standardized education session|40 minute standardized education session based on the Living Well with COPD Patient's Education Tool on study enrolment to assess and improve understanding of disease and ability to monitor symptoms and recognize exacerbation
16166977|NCT01648621|Behavioral|Individualized action plan|Individualized action plan using the Living Well with COPD template with patient individualized modification to address management strategies for exacerbation of comorbidity developed during the initial 40 minute session with case manager.
16166978|NCT01648621|Behavioral|Individualized care plan|Individualized care plan for management of COPD and comorbidities developed by the case manager in consultation with family physician and specialists.
16166979|NCT01648621|Behavioral|Standardized reinforcement/motivational interviewing and action plan teach-back sessions|Standardized reinforcement/motivational interviewing and action plan teach-back sessions based on Living Well with COPD modules as well as assessment of symptoms, progress and problems, and problem solving by phone weekly for 12 weeks, then monthly for 9 months (21 sessions) (telephone script; NOTE: case managers will make up to 3 attempts to contact participants during each week of the 12 weeks of weekly phone calls before determining inability to contact the participant for that week.
16166980|NCT01648621|Behavioral|Tele-home monitoring|"Tele-home monitoring of SpO2, weight, dyspnea, sputum quantity and characteristics, and general well-being for maximum of 6 months.
~Inclusion criteria for tele-home monitoring:
~a. compatible phone line b. patient consent c. patient or caregiver demonstrated ability to use monitoring equipment d. patient unable to attend outpatient/community appointments for assessment and monitoring because of environmental barriers to access (e.g. physician's office only accessible by stairs) e. severe dyspnea on activities of daily living (Medical Research Council Questionnaire for Assessing Severity of Breathlessness [MRC] Class 4 & 5 or modified MRC [mMRC] 3 & 4) f. frequent ED visits (> 2) in last 12 months
~5. 12 weeks of clinical stability with no ED visits."
16167055|NCT01648036|Drug|Unfractionated heparin|Dose: 18 IU/kg/hr, continuous intravenous infusion. Duration: up to 7 days or until ICU discharge or death
16319756|NCT00501514|Drug|Growth hormone|
16166981|NCT01648621|Behavioral|Coordinated and improved communication|Coordinated and improved communication between the patient, family caregivers, family physicians, specialists, and Community Care Access Centres (CCACs) facilitated by the case manager. This will include phone contact by case manager to family physicians and CCAC case manager if applicable after initial enrollment, education session and development of action plan, then monthly to report general status as well as after subsequent ED presentations/hospital admissions
16166982|NCT01648621|Behavioral|Priority access|Priority access to ambulatory clinics (Respirology and other specialties as required including Psychiatry) facilitated through the case manager.
16166983|NCT01648621|Behavioral|Dictated patient summary|Dictated patient summary sent by specialists (e.g. respirologists) to family physicians following each respiratory centre visit (every 12 weeks)
16166984|NCT01648621|Behavioral|in-hospital rehabilitation/self-management program|"Referral to an 8 week in-hospital rehabilitation and self-management education program for patients that are:
~have had a recent exacerbation, but are now clinically stable;
~symptomatic COPD including reduced activity levels and increased dyspnea despite pharmacological treatment;
~have stabilized comorbidity (no evidence of active ischemic, musculoskeletal, psychiatric or other systemic disease); and
~have sufficient motivation to participate."
16166985|NCT01648621|Behavioral|Smoking cessation|Referral to a smoking cessation program (as applicable)
16166986|NCT01648621|Behavioral|Action plan Respirologist|Individualized action plan developed with treating respirologist at the discretion of the attending respirologist.
16166987|NCT01648621|Behavioral|Web based self management materials|Referral to educational materials and resources (Living Well with COPD module printouts provided during COPD rehabilitation classes at a cost to the individual)
16166988|NCT01648608|Drug|Exemestane|Exemestane for neoadjuvant chemotherapy
16166989|NCT01648595|Drug|Fentanyl|In case group, 50 micrograms fentanyl was prescribed in two doses with an interval of 1 hour after being diluted in 4 cc normal saline
16166990|NCT01648582|Drug|Dulaglutide|Administered SC
16166991|NCT01648582|Drug|Insulin glargine|Administered SC per dosing titration schedule
16166992|NCT01648582|Drug|Metformin|Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
16166993|NCT01648582|Drug|Sulfonylureas|Administered orally at pre-study prescribed dose, and is not being provided as part of the trial.
16166994|NCT01648556|Other|Blood tests and bone marrow biopsy repeated|"Blood tests are realized for the dosage of the TPO, the dosage of the antiplatelet antibodies, to measure isotopic lifetime of platelet.
~The test in corticoids by the prednisone per os is realized too. The bone marrow biopsy is realized at the inclusion and during follow-ups if the haemogram is abnormal."
16166995|NCT01648543|Procedure|lumbar sympathetic ganglion block|
16166996|NCT01648530|Other|No Treatment|No Treatment
16166997|NCT01648517|Drug|chemotherapy|A1: docetaxel 60mg/m2 on Day 1 vinorelbine 20mg/m2 on Day 1 and Day 8 (DV) A2: gemcitabine 1000mg/m2 on Day 1 vinorelbine 25mg/m2 on Day 1 and Day 8 (GV) A3: docetaxel 75mg/m2 on Day 1 carboplatin AUC5 on Day 1 (DC) A4: gemcitabine 1000mg/m2 on Day 1 and 8 carboplatin AUC5 on Day 1 (GC)
16166998|NCT01648517|Drug|chemotherapy|Drug: Docetaxel 75mg/m2 IV on Day 1 Drug: Carboplatin AUC5 IV on Day 1
16166999|NCT01648504|Other|eGuide to Colonoscopy and in office ipad education|The investigators will follow patients who receive in office Ipad video education and at home web portal access to the Johns Hopkins eGuide to Colonoscopy.
16167000|NCT01648491|Procedure|Muscle Biopsy|Biopsy of thigh muscle to obtain stem cell core.
16167001|NCT01648491|Biological|Injection of autologous stem cells|After autologous stem cells have multiplied over 6 weeks time they are injected into the subjects urethra.
16167002|NCT01648478|Other|It is a hyperinsulinemic-euglycemic clamp.|"The hyperinsulinemic-euglycemic clamp includes three periods:
~A basal period (from T-30 to T0)
~The infusion of insulin at a constant rate (first level at 1 mUI.kg-1.min-1 and a second level at 2 mUI.kg-1.min-1) during 4 hours ( to obtain stable hyperinsulinemia)
~The infusion of glucose at variable rate (so as to maintain euglycemia)"
16167003|NCT01648465|Drug|Everolimus|Everolimus 10mg(2x5mg)orally once daily until disease progression, unacceptable toxicity or consent withdrawal
16167004|NCT01648452|Biological|NT-501 CNTF-releasing implant|20 ng/day released into the eye
16167005|NCT01648348|Biological|Anti-Endoglin Chimeric Monoclonal Antibody TRC105|Given IV
16167006|NCT01648348|Biological|Bevacizumab|Given IV
16167007|NCT01648348|Other|Laboratory Biomarker Analysis|Correlative studies
16167008|NCT01648348|Other|Pharmacological Study|Correlative studies
16167009|NCT01648348|Other|Quality-of-Life Assessment|Ancillary studies
16167010|NCT01648335|Device|Immobilization of the shoulder in external rotation in a soft dressing called universal shoulder immobilizer (USI)|
16167011|NCT01648335|Device|Immobilization of the shoulder in internal rotation in a soft dressing called universal shoulder immobilizer (USI)|
16167012|NCT01648322|Drug|F-627|subcutaneous injection given 1 per chemotherapy.
16167013|NCT01648322|Drug|Neulasta® (pegfilgrastim)|Single dose injection given once per chemotherapy cycle.
16167014|NCT01648309|Other|Neuropsychological testing|This is an observational study
16167015|NCT01648296|Drug|[18F]FluorbetaOx|Fluorine 18-labeled FluorbetaOx
16167016|NCT01648283|Drug|IV racemic methadone HCl|IV racemic Methadone HC1 6 mg
16167017|NCT01648283|Drug|Oral racemic methadone HCl|oral d5-methadone HCl 11 mg
16167018|NCT01648270|Drug|buprenorphine|Session 1 Intravenous buprenorphine: 0.2 mg over 1 hr Session 2 Sublingual buprenorphine: 2 mg Session 3 Intravenous buprenorphine 0.2 mg over 1 hr beginning 1 hr after starting cyclosporine Session 4 Sublingual buprenorphine: 2 mg after cyclosporine.
16167019|NCT01648257|Drug|GSK1265744 Na Salt Tablets|Each tablet contains 30 mg of GSK1265744 sodium salt and excipients.
16167020|NCT01648257|Drug|GSK1265744 Free Acid Nanomilled Capsules|Each capsule contains 30 mg of nanomilled and spray dried GSK1265744 free acid, blended with excipients.
16167021|NCT01648257|Drug|GSK1265744 Free Acid Micronized Capsules|Each capsule contains 30 mg of micronized GSK1265744 free acid, blended with excipients.
16167053|NCT01648049|Behavioral|Integrated Cognitive Behavioral Therapy (CBT)|CBT treatment is an abbreviated protocol based on manualized, evidence-based treatments for geriatric insomnia (Lichstein & Morin, 2000) and geriatric depression (Thompson, Gallagher-Thompson, & Dick, 1995).
16322360|NCT00482222|Biological|cetuximab|
16167022|NCT01648244|Other|Computer-Assisted Decision Support|"The CADS software makes a recommendation about what medication changes are appropriate with potential alternates. CADS providers will either accept or reject the recommendation by the software.Providers with their patients are block randomized into CADS or Usual Care for 1 year. Patients associated with a CADS provider will upload their blood glucose data weekly and perform a 7-point glucose profile once per month. They will report major hypoglycemic events and hospitalizations at the time of their quarterly visit. Those getting usual care will be seen quarterly and will do self-monitoring of blood glucose and have A1c tests as determined by the provider but no less than twice a year."
16167023|NCT01648231|Drug|Reference Treatment: 1 x 5mg amlodipine tablet and 1 x 100mg losartan tablet administered in fasted state|1 x 5mg amlodipine tablet and 1 x 100mg losartan tablet administered in fasted state
16167024|NCT01648231|Drug|Fixed Dose Combination 1: 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state|1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state
16167025|NCT01648231|Drug|Fixed Dose Combination 2: 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state|1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state
16167026|NCT01648218|Drug|Neutral protamine hagedorn (NPH) insulin|
16167027|NCT01648218|Drug|Regular human insulin or Insulin Aspart|
16167028|NCT01648218|Drug|Insulin glargine|
16167029|NCT01648205|Drug|Placebo|Matching Placebo will be given
16167030|NCT01648205|Drug|Ranolazine|Patients will receive ranolazine 1000mg bid or matching placebo
16167031|NCT01648192|Drug|Losmapimod for single dose|Film coated white tablet
16167032|NCT01648192|Drug|Losmapimod for repeat dose|Film coated white tablet
16167033|NCT01648179|Drug|GSK1322322 (mesylate salt) Powder for Injection|1500 mg (mesylate salt) as free base, dissolved in sterile water for injection to a concentration of 100 mg/mL free base equivalent and sterilized via filtration. 15 mL of solution, equivalent to 1500 mg GSK 1322322, is the diluted into 0.9% Sodium Chloride Injection prior to infusion
16167034|NCT01648179|Drug|GSK1322322 (freebase) tablets|500 mg tablets for a 1500 mg total single dose (3 tablets). Taken with 240 mL of water
16167035|NCT01648179|Drug|GSK1322322 (mesylate salt) Powder for Oral Solution|1500 mg as a free base, dissolved in purified water to a concentration of 100 mg/mL free base equivalent. 15 mL of solution, equivalent to1500 mg GSK1322322 is administered orally with 225 mL of water
16167036|NCT01648179|Drug|GSK1322322 (freebase) tablets FED|Drug 500 mg tablets for a 1500 mg total single dose (3 tablets) (FED moderate fat meal) Taken with 240 mL of water
16167037|NCT01648166|Other|Environmental sampling|Soil, water, blood, urine, hair and radon testing in homes in Appalachia
16167038|NCT01648153|Biological|GSK1070806|To investigate the efficacy and biomarker changes of GSK1070806 after 0.25mg/kg IV administration
16167039|NCT01648153|Other|Placebo (saline)|To compare the efficacy and biomarker changes between placebo and active groups
16167040|NCT01648153|Biological|GSK1070806|To investigate the efficacy and biomarker changes of GSK1070806 after 5mg/kg IV administration
16167041|NCT01648140|Drug|GSK2336805 40 mg|20 mg tablet, round, 10-mm diameter, white to off-white, no markings
16167042|NCT01648140|Drug|GSK2336805 60 mg|30 mg tablet, round, 10-mm diameter, white to off-white, no markings
16167043|NCT01648140|Drug|Pegylated interferon alpha-2a|180 microgram per 0.5 mL prefilled syringe for single use
16167044|NCT01648140|Drug|Ribavirin|"200-mg tablet, capsule-shaped, light blue, film-coated, and debossed with 200 on 1 side and the logo 3RP on the other side"
16167045|NCT01648140|Drug|Telaprevir|375 mg film-coated tablet
16167046|NCT01648127|Drug|Ceftaroline|A single dose of ceftaroline fosamil 600 mg as a 1-hour continuous intravenous infusion
16167047|NCT01648114|Other|Antenatal Breastfeeding Intervention|The intervention will include a 20 to 30-minute one-to-one educational talk by a lactation expert explaining the facts of breastfeeding and answering participant questions. The educational intervention will focus on: (1) the importance of exclusive breastfeeding, (2) milk supply/demand and feeding on demand, (3) frequency of feedings, feeding cues, how to know an infant is getting enough milk, (4) avoiding artificial nipples until the infant is nursing well, (5) the importance of a good latch, (5) where to seek breastfeeding help and support, and (7) returning to work and continuing breastfeeding
16167048|NCT01648101|Drug|Retigabine 900mg/day|Study drug will be administered three times a day in a double blind manner. The starting dose of retigabine will be 300 mg/day. This dose will be increased by 150 mg/day per week to reach the target dose of 900mg/day over a 4 week Titration Phase). The subject will then continue to receive 900mg/day for the next 12 weeks (Maintenance Phase). Eligible subjects will then be offered an opportunity to enter an open label extension (OLE) study. After a 4 week transition phase, eligible subjects will start the OLE on retigabine 900mg/day.
16167049|NCT01648101|Drug|Retigabine 600mg/day|Study drug will be administered three times a day in a double blind manner. The starting dose of retigabine will be 300mg/day. This dose will be increased by 150 mg/day per week to reach the target dose of 600mg/day over 2 weeks. The subject will then continue to receive 600mg/day for the next 14 weeks (2 weeks of the Titration Phase and 12 weeks of the Maintenance Phase). Eligible subjects will then be offered an opportunity to enter an open label extension (OLE) study. After a 4 week Transition Phase (3 weeks on retigabine 600mg/day, 1 week on retigabine 750mg/day) eligible subjects will start the OLE on retigabine 900mg/day.
16167050|NCT01648101|Other|Placebo|Study drug will be administered three times a day in a double blind manner. Subjects randomised to placebo will receive the same number, size and colour of tablets as the 600mg/day and 900mg/day treatment arms for the duration of the 4 week Titration Phase and the 12 week Maintenance Phase. Eligible subjects will then be offered an opportunity to enter an open label extension (OLE) study. The starting dose of retigabine will be 300 mg/day. This dose will be increased by 150 mg/day per week to reach dose of 750mg/day over the 4 weeks of the Transition Phase. On completion of the Transition Phase eligible subjects will start the OLE on retigabine 900mg/day.
16167051|NCT01648075|Dietary Supplement|Experimental: Probiotic enriched milk|Milk will be enriched with lactobacillus rhamnosus for the experimental group.
16167052|NCT01648062|Behavioral|Sleep Self-Regulation Using Mental Imagery|Comparison of two forms of mental imagery to instigate behaviors that assist in the sleeping process
16167054|NCT01648049|Behavioral|Treatment as usual|Standard Care - Treatment as usual
16167056|NCT01648036|Drug|Dalteparin|Dose 5000 IU, subcutaneous, daily
16322361|NCT00482222|Drug|capecitabine|
16167059|NCT01648010|Device|TC-3 gel|One intravesical instillation of 40 cc of TC-3 hydrogel is instilled using catheter.
16167060|NCT01648010|Device|TC-3 gel mixed with Mitomycin C (MMC)|One intravesical instillation of 40 cc of TC-3 gel mixed with 40 mg MMC will be instilled using catheter
16167061|NCT01647997|Other|bacterial endotoxin challenge|iv administration of 2ng/kg bacterial endotoxin
16167062|NCT01647984|Dietary Supplement|Ritmonutra|Ritmonutra ® contains: 720 mg of Fish Oil with Omega-3, including 480 mg of EPA and 40 mg of DHA, Hawthorn (extract from Crataegus mongyna) 300 mg equivalent to 5.4 mg of vitexin, 4 mg of Astaxanthin and 36 mg of Vitamin E
16167063|NCT01647984|Dietary Supplement|placebo|
16167064|NCT01647971|Drug|Ublituximab|Ublituximab is a novel monoclonal antibody targeting CD20
16167065|NCT01647958|Device|EsophyX System with SerosaFuse fasteners|Transoral Incisionless Fundoplication (TIF)/Transoral incisionless esophago-gastric fundoplication using the EsophyX System with SerosaFuse fasteners
16167066|NCT01647958|Drug|PPI|Control Arm participants will take maximum standard dose of PPI during Initial Study period
16167067|NCT01647945|Drug|Placebo|placebo pill
16167068|NCT01647945|Drug|FK506 level < 2 ng/ml|FK506 goal trough blood level < 2 ng/ml
16167069|NCT01647945|Drug|FK506 level 2-3 ng/ml|FK506 goal trough blood level 2-3 ng/ml
16167070|NCT01647945|Drug|FK506 level 3-5 ng/ml|FK506 goal trough blood level 3-5 ng/ml
16167071|NCT01647932|Drug|hydrochlorothiazide|hydrochlorothiazide according to clearance of creatinine; >50ml/min 25mg daily, 20-50ml/min 50mg daily amd <20ml/min 100mg daily.
16167072|NCT01647932|Drug|Placebo|Placebo according to clearance of creatinine; >50ml/min 1/2 pill daily, 20-50ml/min 1 pill daily amd <20ml/min 2 pills daily.
16167073|NCT01647919|Dietary Supplement|cogniVida™ 100 mg/day|4 capsules 25 mg (total 100 mg) cogniVida™ once a day
16167074|NCT01647919|Dietary Supplement|Placebo|4 capsules of placebo identical to cogniVida™ once a day
16167075|NCT01647893|Drug|CTB-001|IV bolus or IV infusion
16167076|NCT01647880|Drug|Verum arm receiving Gilenya®|
16167077|NCT01647880|Drug|Active Comparator receiving Extavia®|
16167078|NCT01647867|Other|Met analysis on tissue and blood|10 mL of blood and 4 pieces of tissue (2 of tumor tissue, 2 of healthy tissue) all taken at the same time as surgery or bronchoscopy, depending on the stage of the disease
16167079|NCT01647854|Procedure|Teleconsultation|Teleconsultation in prehospital emergencies
16167080|NCT01647828|Drug|OMP-59R5|OMP-59R5 administered intravenously
16167081|NCT01647828|Drug|Gemcitabine|administered intravenously
16167082|NCT01647828|Drug|Placebo|administered IV
16167083|NCT01647828|Drug|Nab-Paclitaxel|administered intravenously
16167084|NCT01647815|Procedure|Ultrasound measures|Ultrasound will be used to measure the surfaces of the axillary and subclavian veins with the arms in different positions. Our goal is to compare the vein surface area available among different vein-position combinations. Our goal does not include testing specific devices.
16167085|NCT01647802|Device|"Standing attempts with the Vertic'Easy Device"|Included patients had never used any of the three devices evaluated in this study. Therefore the patient will make two attempts at standing on each device to enable him/her to get used to the device at the first attempt. A video recording will be made from a camera positioned laterally. Only the results of the second attempt will be a kinematic analysis and will be used for analyzes.
16167086|NCT01647802|Device|"Standing attempts with the Turner Device"|Included patients had never used any of the three devices evaluated in this study. Therefore the patient will make two attempts at standing on each device to enable him/her to get used to the device at the first attempt. A video recording will be made from a camera positioned laterally. Only the results of the second attempt will be a kinematic analysis and will be used for analyzes
16167087|NCT01647802|Device|"Standing attempts with the Tina device"|Included patients had never used any of the three devices evaluated in this study. Therefore the patient will make two attempts at standing on each device to enable him/her to get used to the device at the first attempt. A video recording will be made from a camera positioned laterally. Only the results of the second attempt will be a kinematic analysis and will be used for analyzes
16167088|NCT01647789|Drug|CFG920|
16167089|NCT01647776|Other|Stool DNA Test|Stool DNA test is done prior to the colonoscopy.
16167090|NCT01647776|Procedure|biopsies of rectal and colon mucosa|During the standard of care colonoscopy biopsies of rectal and colon mucosa will be taken for analysis of 15-PGDH pathway factors [levels of prostaglandin E2 (PG E2), and mRNA for 15-PGDH, COX-1 and COX-2 expression] as markers of risk of developing adenoma.
16167091|NCT01647776|Other|Questionnaires|A Food Frequency Questionnaire (FFQ), a Meat Preparation Questionnaire (MPQ), and a Physical Activity Questionnaire (PAQ), all developed at the University of Arizona Cancer Center will be used to collect dietary and physical activity data. Risk Factor Questionnaire (RFQ) developed by the University of Southern California will be used to collect general risk information. Stool (sDNA) test patient satisfaction survey.
16167092|NCT01647763|Procedure|Hemorrhoidal artery ligation with rectoanal repair|"Hemorrhoidal arteries will be detected using an ultrasound Doppler probe. The arteries will be sutured with at least 4 Z-sutures.
~In the area with the 3 largest knots a purse string suture will be placed."
16167093|NCT01647763|Procedure|Stapled hemorrhoidopexy|A purse string suture will be placed just below the hemorrhoidal cushion. Fixing the suture around the shaft of a circular PPH 03 stapler (Ethicon Endo-Surgery). Hemorrhoids will be removed by firing the stapler. Sufficiency of the stapler line will be examined through a proctoscope. Eventual sources of bleeding will be sutured.
16167094|NCT01647750|Drug|Levothyroxine|Participants in the lower dose arm of the study will receive a lower dose of levothyroxine than their usual dose
16167095|NCT01647750|Drug|Levothyroxine|Participants in the standard dose of treatment will receive their usual dose of levothyroxine
16167096|NCT01647737|Dietary Supplement|MighTeaFlow|4-6 times daily
16167097|NCT01647737|Dietary Supplement|Xylitol|4-6 times daily
16167098|NCT01647711|Drug|Dose escalation followed by treatment with MTD|Fixed 3+3 dose escalation; expansion of MTD cohort
16167099|NCT01647698|Behavioral|Adaptive working memory training task|"The working memory training task will consist of an adaptive working memory computer program that will test and extend patients' working memory capacity.
~Adaptive refers to the increase in the number of items that the patient is required to remember."
16167100|NCT01647698|Behavioral|Non-adaptive working memory training task (i.e. an active control task)|Active control task will consist of a non-adaptive working memory task.
16167101|NCT01647698|Behavioral|No training|No training during the experiment.
16167102|NCT01647685|Drug|Nanocort|Two weekly IV infusions of 150 mg Nanocort (PEG-liposomal prednisolone sodium phosphate).
16167103|NCT01647685|Drug|Methylprednisolone|Two weekly infusion iv methylprednisolone sodium succinate 125 mg infusion.
16167104|NCT01647685|Drug|Placebo|Saline solution (same solution brand as used to dilute/prepare Nanocort injection)
16167105|NCT01647672|Drug|Abraxane|Abraxane for neoadjuvant chemotherapy
16167106|NCT01647659|Drug|Trametinib tablet|2 mg, orally, on Day 1 of the dosing period
16167107|NCT01647659|Drug|Trametinib pediatric formulation|2 mg, orally, on Day 1 of the dosing period
16167108|NCT01647646|Drug|Seretide|Using Symbicort and Seretide for asthma control measurements Compared with efficacy and safety
16167109|NCT01647633|Other|Calcium Glycerophosphate Nasal Spray Wash|Nasal wash two to six times per day
16167110|NCT01647620|Drug|DPOC-4088|A 10-day oral dosing of DPOC-4088 prolonged release tablet (20 hr release formulation). Starting dose in dose step 1 is 100 mg daily.
16167111|NCT01647620|Drug|Placebo|A 10-day oral dosing of matching placebo prolonged release tablet.
16167112|NCT01647607|Behavioral|Young Women's Intervention (YWI)|This educational intervention uses print and web-based materials to focus on issues unique to young women with breast cancer, including career development, starting/raising a family, body image, and genetic predispositions to breast cancer.
16167113|NCT01647607|Behavioral|Physical Activity Intervention (PAI)|This educational intervention uses print and web-based materials that focus on developing and/or maintaining a healthy lifestyle for young women with breast cancer, including the benefits of exercise and resources to enhance physical activity after diagnosis.
16167114|NCT01647594|Behavioral|YWI|The YWI consists of print and web-based materials. Content for this group will include detailed information about issues facing young women with breast cancer, risks, discussion points and and resources. The following domains will be addressed: health/medical issues (i.e., side effects, breast cancer recurrence, long-term risks, genetic issues), psychosocial issues (coping, relationship and family concerns), beauty/body image, sexual functioning, fertility concerns, and work/school issues.
16167115|NCT01647594|Behavioral|Physical Activity|The PAI serves as the control group. This intervention consists of print and web-based materials, the content of which includes detailed information about the benefits of exercise in breast cancer survivors and discussion points, available options and resources to enhance physical activity after diagnosis.
16167116|NCT01647581|Device|Hemoclip Placement|Placement of hemoclip at polypectomy site for polyps at least 1cm in size
16167117|NCT01647581|Device|NO hemoclip placement|No hemoclip placement (placebo / sham)
16167118|NCT01647555|Drug|Cetuximab|First cycle: 400 mg/m2 Next cycles: 250 mg/m2
16167119|NCT01647555|Radiation|Radiotherapy|Curative dose: 66 to 70 Gy
16167120|NCT01647542|Drug|TAK-875|TAK-875 tablets
16167121|NCT01647542|Drug|TAK-875 Placebo|TAK-875 placebo-matching tablets
16167122|NCT01647529|Drug|Ganciclovir|Treatment with topical ganciclovir ointment
16167123|NCT01647516|Drug|Ozanimod|Ozanimod capsules by mouth daily.
16167124|NCT01647516|Drug|Placebo|
16167125|NCT01647490|Procedure|Permanent Cardiac Pacemaker Implantation|
16167126|NCT01647477|Behavioral|interview|25 minutes of semi directive interview
16167127|NCT01647477|Behavioral|questionnaires|questionnaires to answer at baseline 45 minutes
16167128|NCT01647451|Drug|NNC0114-0006|Two i.v. (intravenous) doses administered 6 weeks apart.
16167129|NCT01647451|Drug|placebo|Two i.v. (intravenous) doses administered 6 weeks apart.
16167130|NCT01647438|Behavioral|Lifestyle Intervention|Participants will enroll in heart disease prevention group sessions focusing on physical activity, diet, weight, and stress management. Each group will have 6 to 8 participants who will attend 6 weekly, 90 minute group education sessions at Metropolitan Asian Family Services. During each session, participants will watch videos on the day's topic followed by discussion, activities, and assistance in setting realistic goals with attention to physical activity, diet, weight, and stress management. Participants will receive telephone support after each session and up to 12 weeks after they have completed the classes to help reinforce learning objectives.
16167131|NCT01647438|Other|Print Health Education|Participants will receive primary care referrals and print health education material about heart disease prevention in the mail.
16167132|NCT01647425|Behavioral|physician assessment|"Socio-economic conditions and general features: educational level, professional status...
~Assessment of current and past use of tobacco: current smoking status reported by the patient; in lifelong non-smokers: previous history of passive smoking reported by the patient; breath carbon monoxide level; in past smokers: age of first cigarette, total reported duration of active smoking, breath carbon monoxide level...
~in current smokers: age of first tobacco use, total reported duration of active smoking; Fagerström Nicotine Dependence Test...
~Assessment of the current and past uses of alcohol: previous-year assessment using the CAGE questionnaire and the AUDIT Test; average weekly alcohol consumption over the last 12 months...
~Assessment of current use of cannabis using the Cannabis Abuse Screening Test
~Psychiatric assessment using the MINI 5.0"
16167133|NCT01647412|Drug|Growth Hormone|Humatrope will be administered daily to patients in a dose of .18-.20 mg/kg/week.
16167134|NCT01647412|Dietary Supplement|Nutraceutical Combination|
16167135|NCT01647412|Other|Exclusion Diet|Patients on the exclusion diet will adhere from consumption of all grain, corn, dairy, and carrageenan containing products.
16167136|NCT01647412|Other|Placebo Growth Hormone|
16167137|NCT01647347|Drug|Supra- and subgingival rinsing with 10% PVP-iodine|rinsing prior to and during subgingival ultrasonic debridement
16167138|NCT01647347|Other|Water|
16167139|NCT01647334|Radiation|Adaptive radiotherapy|
16167140|NCT01647321|Behavioral|Active cycling|The exercise program uses a stationary bike equipped with functional electrical stimulation (FES) of leg muscles. Participants are instructed to actively pedal while the FES is assisting. The training program is expected to be performed for one hour, three times a week for 12 weeks.
16167242|NCT01646242|Procedure|removal of eligible polyps using double biopsy technique|Cold forceps polypectomy using a standard- capacity forceps with double biopsy technique (two bites per one forceps pass)
16167141|NCT01647321|Behavioral|Passive cycling|The exercise program uses a stationary bike equipped with functional electrical stimulation (FES) of leg muscles. Participants are instructed to sit passively on the stationary bile while the FES is assisting. The training program is expected to be performed for one hour, three times a week for 12 weeks.
16167142|NCT01647308|Drug|ISIS-APOCIIIRX|3 doses of ISIS ISIS-APOCIIIRX on alternate days during the first week and then once-weekly doses for 12 weeks.
16167143|NCT01647308|Drug|Placebo|3 doses of placebo on alternate days during the first week and then once-weekly doses for 12 weeks.
16167144|NCT01647282|Drug|locally-applied minocycline HCl (1 mg)|
16167145|NCT01647282|Procedure|scaling and root planing (Sc/RP)|
16167146|NCT01647269|Procedure|Bilateral GPi Deep Brain Stimulation|Bilateral GPi Deep Brain Stimulation
16167147|NCT01647256|Drug|Nikkomycin Z|Capsule, 500 mg, single-dose
16167148|NCT01647243|Other|Preoperative strength training|Progressive strength training on group basis (not more than 3 subjects) 3 sessions weekly starting 4 weeks before the operation, in total 12 sessions Strength training 3 sessions weekly 4 weeks postsurgery
16167149|NCT01647217|Drug|Terpinen-4-ol|Lid scrub once or twice per day for one month.
16167150|NCT01647217|Other|Placebo|Lid scrub once or twice per day for one month
16167151|NCT01647204|Other|trained volunteer mealtime assistance|trained volunteers helped inpatients at lunchtimes with dinner tray preparation, encouragement and feeding if required
16167152|NCT01647191|Behavioral|intervention group|The investigators will use a variety of learning techniques, including lecture, brainstorming, small and large group activity, individual worksheets, role-play, and video player. For example, small teams of up to 5 participants will conduct role-plays; large groups also will be assembled to encourage talking about HCV-related risk reduction behavior.
16167153|NCT01647191|Behavioral|control group|The investigators will adopt previous treatment in the clinics to intervent the patients
16167154|NCT01647178|Procedure|TORQ assisted sternal closure|
16167155|NCT01647178|Procedure|Conventional closure|
16167156|NCT01647165|Drug|Bortezomib|Cycle 1-8: 1.0 mg/m2 SC at a concentration of 2.5 mg/ml or 1 mg/ml to the thighs or abdomen on days 1, 4, 8, 11 of a 21 day cycle for 8 cycles.
16167157|NCT01647165|Drug|Lenalidomide|Cycle 1: 15 mg oral daily on days 2-14 of 21 day cycle; Cycle 2-8: 15 mg oral daily on days 1-14 of a 21 day cycle
16167158|NCT01647165|Drug|Dexamethasone|Cycle 1: 10 mg oral or IV daily on days 2,4,5,8,9,11,12 of a 21 day cycle; Cycle 2-8: 10 mg oral or IV on days 1, 2, 4, 5, 8, 9, 11, 12 of a 21 day cycle
16167159|NCT01647152|Drug|Ustekinumab|
16167160|NCT01646853|Radiation|Megavoltage photon beam|initial dose:50Gy/2Gy/25f,5days/week escalation dose:4Gy/2Gy/2f
16167161|NCT01646853|Drug|cisplatin-fluorouracil chemotherapy|cisplatin 75 mg/m2 on day 1 with standard hydration fluorouracil 1000 mg/m2/day1 i.v. by continuous infusion from day 1 to day 4 of each cycle
16167162|NCT01646840|Drug|PF-04958242 capsule|Single dose of PF-04958242 0.35 mg oral capsule
16167163|NCT01646840|Drug|PF-04958242 oral solution|Single dose of PF-04958242 0.35 mg oral solution
16167164|NCT01646827|Drug|Aripiprazole IM Depot|One injection of 400 mg aripiprazole IM depot
16167165|NCT01646814|Drug|PL2200|PL2200, containing 325 mg aspirin active ingredient
16167166|NCT01646814|Drug|Aspirin tablets|325 mg aspirin tablets (USP)
16167167|NCT01646801|Device|NMB Balloon Catheter|patients treated by the NMB's Drug Ejecting Balloon
16167168|NCT01646788|Device|NMB Paclitaxel Drug Ejecting Balloon|NMB's PTA Balloon catheter with drug
16167169|NCT01646775|Drug|epidural fentanyl|withold epidural fentanyl
16167170|NCT01646762|Drug|Paclitaxel Albumin-Stabilized Nanoparticle Formulation|Given IV
16167171|NCT01646762|Other|Laboratory Biomarker Analysis|Correlative studies
16167172|NCT01646749|Dietary Supplement|Differences in protein content (En%) of meals|The three applied conditions will differ in the relative protein content of the meals, including 5 En%, 15 En% and 30 En% from protein. Beef protein will be used as main meat protein source in the 15 En% and 30 En% protein conditions. The resulting macronutrient compositions of the diets will be En% Protein/Carbohydrate/Fat; 5/60/35, 15/50/35, and 30/35/35. All meals (breakfast, lunch, dinner) within each condition will have the same macronutrient composition. All food items, and the energy density, weight and volume of the meals will be the same between conditions. All snack items will be very low in protein content.
16167173|NCT01646736|Drug|Tripterygium wilfordii Hook F|Oral T2(Tripterygium wilfordii Hook F) 20mg thrice daily for 24 weeks.
16167174|NCT01646736|Drug|Cyclophosphamide|Cyclophosphamide 1.0 intravenous every month.
16167175|NCT01646736|Drug|GC|Prednisone or equivalent 1 mg/kg/d(up to 60 mg), gradually tapering to 7.5mg/d in 24 weeks.
16167176|NCT01646723|Behavioral|Volunteers Adding Life in Dementia (VALID) Program|"The VALID intervention will consist of 2 phases. First, volunteers will complete an assessment involving recording of a Life Story for each patient participant. This will include information on the patient's psychosocial history, occupational history, hobbies, interests and preferred activities using information from the LTC medical record and interviews with the patient and family members. Based on this information, a variety of potential psychosocial interventions will be developed for the individual with the assistance of the recreation therapist at the LTC. The second phase will involve implementation of the VALID intervention. Each individual with dementia will receive personalized pleasant activities for a minimum session of 30 minutes at a frequency of 3 times per week. One volunteer will complete the Life Story assessment and up to 3 volunteers may be involved with implementing the VALID program for each resident."
16167177|NCT01646710|Behavioral|Pretesting food based recommendations|
16167178|NCT01646697|Other|cytology specimen collection procedure|Undergo cytopathologic sample collection
16167179|NCT01646684|Drug|SOM230|
16167180|NCT01646671|Drug|LCZ696|LCZ696 200 mg tablet once daily
16167181|NCT01646671|Drug|LCZ696|2 tablets of LCZ696 200 mg once daily titrated up from 1 tablet of 200 mg once daily
16167182|NCT01646671|Drug|LCZ696|2 tablets of LCZ696 200 mg once daily titrated up from 1 tablet of 200 mg once daily plus other HTN medications
16167243|NCT01646229|Other|Polymyxin-B hemoperfusion|
16167244|NCT01646229|Other|Control|
16167285|NCT01645904|Behavioral|Demographic Questionnaire|Complete questions about demographics (age, race, marital status) and medical history. This visit should take about 1 hour to complete.
16167183|NCT01646645|Biological|CMV-pp65 CTLs|Patients will be treated with CMVpp65-CTLs derived from their transplant donor. These will be patients with CMV seropositive transplant donors who have previously provided leukocytes for generation of CMVpp65-CTL and for whom such CMVpp65-CTL are available. The T-cells to be infused will be selected based on criteria mentioned in section 4.0 from our bank of GMP grade CMVpp65-CTL. T-cells will be administered by bolus intravenous infusion. In this phase II trial, patients will be treated at doses of 1 x 106 CMVpp65-CTL/kg/dose/week for 3 weeks. Patients will be observed for the following 3 weeks. Additional 3 week courses of CMVpp65-CTL may be administered if levels of CMV DNA in blood are still detectable despite disease stabilization or improvement.
16167184|NCT01646632|Behavioral|Physical exercise intervention|the experimental intervention included group- based progressive resistance training, balance training, and functional training, two times a week, one hour sessions, lasting 16 weeks.
16167185|NCT01646632|Behavioral|Lifestyle counseling|the control intervention included recreational sessions, including talks, video's, music, board games etc. No physical activity was involved in the control intervention.
16167186|NCT01646619|Drug|Magnesium Sulphate|"10% MgSo4 (100mg/ml) given in a dose of 250mg/kg IV q 24 hrly for 3 doses(2.5ml/kg).
~Diluent: Dextrose 5%."
16167187|NCT01646619|Drug|Placebo|Normal Saline 0.9% Sodium Chloride is diluted in 5% Dextrose to be given as 2.5ml/kg IV q24 hrly for 3 doses.
16167188|NCT01646606|Procedure|Intermittent oxygen monitoring|Oxygen saturation and vital signs will be measured intermittently at a frequency of every 4 hours by the bedside nurse through the child's hospital stay until discharge. The nurse will attach the probe to the electrical cord which is connected to the monitor. For each measurement, the duration of monitoring will be until a steady wave form is present on the oxygen saturation monitor, indicating a reliable measurement (consistent with current standard of practice). The nurse will document the maximum and minimum reading during the period. The nurse will detach the probe from the electrical cord, leaving the probe attached to the child. Hence, the child's probe will be attached to the electrical cord intermittently as well.
16167189|NCT01646606|Procedure|Continuous oxygen monitoring|Oxygen saturation will be measured continuously through the child's hospital stay until discharge. Every 4 hours the nurse will complete and document a set of vital sign measurements, including oxygen saturation level, in keeping with current clinical practice. The reading will be displayed on the bedside monitor in the participants' room. At the completion of vital signs measurement, the nurse will not detach the electrical cord from the probe. Hence, the child's probe will be attached to the electrical cord continuously as well.
16167190|NCT01646593|Drug|Regorafenib (BAY73-4506)|160 mg BAY73-4506, 3 weeks on drug, 1 week off
16167191|NCT01646580|Drug|ciclopirox|Doses of 1.0% cream. Topical cream application. Twice daily for 28 days. Duration of treatment: 28 days with four weeks follow-up.
16167192|NCT01646567|Drug|SHP-141C|Topical Cream
16167193|NCT01646567|Drug|Placebo to SHP-141C|Placebo Topical Cream
16167194|NCT01646567|Drug|Betamethasone Valerate|Topical cream, 0.02%
16167195|NCT01646567|Drug|Calcipotriol|Topical cream, 0.005%
16167196|NCT01646554|Drug|Modified FOLFOX6|
16167197|NCT01646554|Biological|Aflibercept|Targeted therapy
16167198|NCT01646554|Procedure|Surgery|
16167199|NCT01646528|Procedure|CLE examination for upper gastrointestinal tract|Routine upper GI endoscopy plus targeted CLE examination
16167200|NCT01646515|Drug|Placebo|"Capsule, appears identical with udenafil, will be provided by Dong-A pharmaceutical company.
~Patients will receive 50 mg of placebo drug two times a day for 4 weeks, and then the dosage will be escalated to 100 mg two times a day for next 8 weeks"
16167201|NCT01646515|Drug|Udenafil (Zydena)|Udenafil (Zydena), a newly developed PDE-5 inhibitor by Dong-A pharmaceutical company, will be administered to patients in this group, 50 mg two times a day for 4 weeks, and then the dosage will be escalated to 100 mg two times a day for next 8 weeks.
16167202|NCT01646502|Biological|Esp protein|
16167203|NCT01646502|Other|Standard wound care|
16167204|NCT01646489|Drug|Miravirsen sodium|Miravirsen 7 mg/kg to be administered as single subcutaneous injections for a total of 5 doses over a 5 week treatment period.
16167205|NCT01646489|Drug|Telaprevir|Telaprevir 750 mg to be administered as single and multiple oral doses over two 7 day treatment periods.
16167206|NCT01646476|Device|Covered stent (Bona stent pyloric/duodenal covered) insertion|self-expandable metallic stent placement was performed with a therapeutic endoscope (working channel ≥ 3.7 mm) using a through-the-scope method. All patients underwent procedures under conscious sedation with midazolam and pethidine. The length of the stricture was assessed either endoscopically or fluoroscopically; the length of the stent had to exceed that of the stricture by at least 3 cm. After the required stent length was determined, the stent was advanced through the endoscope over a guidewire until it passed across the distal end of the stricture. Then, the stent was deployed under continuous fluoroscopic control. For the Wave covered stent group, the stent was repositioned after deployment using the lasso under fluoroscopic guidance (if necessary), aligning the central portion of the stricture with the central portion of the stent which had reduced radial force and indentation. Stent positioning was confirmed endoscopically and fluoroscopically.
16167207|NCT01646476|Device|Uncovered stent (Bona stent, pyloric/duodenal) insertion|Self-expandable metallic stent placement was performed with a therapeutic endoscope (working channel ≥ 3.7 mm) using a through-the-scope method. All patients underwent procedures under conscious sedation with midazolam and pethidine. The length of the stricture was assessed either endoscopically or fluoroscopically; the length of the stent had to exceed that of the stricture by at least 3 cm. After the required stent length was determined, the stent was advanced through the endoscope over a guidewire until it passed across the distal end of the stricture. Then, the stent was deployed under continuous fluoroscopic control. For the Wave covered stent group, the stent was repositioned after deployment using the lasso under fluoroscopic guidance (if necessary), aligning the central portion of the stricture with the central portion of the stent which had reduced radial force and indentation. Stent positioning was confirmed endoscopically and fluoroscopically.
16167282|NCT01645930|Drug|Dexamethasone|Dexamethasone tablets
16167283|NCT01645917|Device|Arctic Front Advance Cardiac CryoAblation system|Standard of care ablation for indicated paroxysmal AF patients with Medtronic's Arctic Front Advance Cardiac CryoAblation system
16167284|NCT01645904|Behavioral|Audiotaped Focus Group|Participation in a focus group regarding web-based program designed to improve communication of health and health history information among family members affected by Lynch syndrome.
16167208|NCT01646463|Behavioral|CenteringPregnancy|CenteringPregnancy (CP) follows a standardized curriculum for group-based prenatal healthcare offered to groups of 10-12 women with similar due dates. In lieu of receiving a series of individually-delivered prenatal healthcare, participants meet 10 times over the course of pregnancy and early postpartum for 2 hour sessions, essentially pooling their minutes for each prenatal healthcare visit. The visit schedule adheres to the guidelines set forth by ACOG of monthly and then weekly visits close to birth. All sessions of CP include three core components of: (1) physical assessment (including blood pressure, weight, and fundal height assessment), (2) education and skills-building, and (3) support. Content topics for group discussion include nutrition, exercise, relaxation, understanding pregnancy problems, infant care and feeding, postpartum issues including contraception, comfort measures in pregnancy, sexuality and childbearing, abuse issues, parenting, and childbirth preparation.
16167209|NCT01646463|Behavioral|CenteringPregnancy with Mindfulness Skills|CenteringPregnancy with Mindfulness Skills contains the CenteringPregnancy (CP) content combined with training in mindfulness meditation and mindful movement/yoga. The mind-body methods have been adapted from those taught in the Mindfulness-Based Childbirth and Parenting (MBCP) course, which is a tailored version of the Mindfulness-Based Stress Reduction program delivered to pregnant women during the perinatal period. These practices include mindfulness meditation of the breath, body, feelings, thoughts, and emotions; body scan meditation; yoga postures practiced with mindful awareness of the body and the physical changes associated with pregnancy; and loving-kindness meditation. In addition, MBCP includes specific exercises in coping with stress, pain, and fear associated with pregnancy, childbirth, and early parenting with a focus on shifting the way participants relate to negative thoughts and emotions and cope with stress.
16167210|NCT01646450|Drug|Icotinib|Icotinib: 125mg, oral administration, three times per day.
16167211|NCT01646437|Drug|Polycap|Polycap (thiazide 25mg, atenolol 100mg, ramipril 10mg, simvastatin 40mg) taken once daily
16167212|NCT01646437|Drug|Aspirin|75 mg daily
16167213|NCT01646437|Drug|Vitamin D|60,000 IU monthly
16167214|NCT01646437|Drug|Matching Placebo|Matching Placebo
16167215|NCT01646398|Biological|13-valent pneumococcal conjugate vaccine|A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.
16167216|NCT01646398|Biological|23-valent pneumococcal polysaccharide vaccine|A single dose (0.5 mL) will be administered intramuscularly into the deltoid muscle at visit 1.
16167217|NCT01646385|Drug|etanercept|use as per routine clinical practice
16167218|NCT01646385|Drug|non-biologic anti-rheumatic drugs|use as per routine clinical practice (methotrexate, azathioprine, cyclophosphamide, cyclosporine, leflunomide, other)
16167219|NCT01646372|Other|Standard Simulation Based ACLS Refresher Teaching|45min-1 hour time. 15 minutes didactic review of 2010 ACLS guidelines followed by practice simulated megacodes
16167220|NCT01646372|Other|Cognitive Aid based ACLS Refresher training|45min-1 hour time. 15 minutes didactic review of 2010 ACLS guidelines followed by simulated ACLS megacode practice focused on the use of Cognitive Aids to guide management.
16167221|NCT01646359|Device|1.Esophageal doppler monitor|1.Esophageal doppler monitor (CARDIO Q®, DELTEX MEDICAL. Brighton, U. K.)-inserted into the esophagus and positioned approximately 35-40 cm from the teeth. The position of OED prove was confirmed by continuously measuring blood flow velocity in the descending thoracic aorta and focused to find the optimum peak velocity and waveform signal.
16167222|NCT01646359|Device|2. philips Intelivue MP70 monitors|2.philips Intelivue MP70 monitors (Intellivue MP70, philips medical Systems, Suresnes, France) -a radial arterial cannula was inserted and arterial pressure waveforms were monitored through Philips Intelivue MP70 monitors. In the monitor, PPVauto was displayed in real-time. It based on automatic detection algorithms, kernel smoothing, and rank-order filters.
16167223|NCT01646346|Radiation|4D Conformal Image-Guided Partial Breast RT|External beam partial breast radiation to target a portion of the breast twice a day for 5 days.
16167224|NCT01646333|Behavioral|Memory and Problem-Solving Intervention|8 weekly 1 hour sessions of memory compensation and problem-solving strategies
16167225|NCT01646333|Behavioral|Supportive Therapy|8 weekly 1 hour sessions of non-directive supportive therapy.
16167226|NCT01646320|Drug|Dapagliflozin|Tablets, Oral, 10 mg, Once daily, Up to 52 weeks
16167227|NCT01646320|Drug|Placebo matching with Dapagliflozin|Tablets, Oral, 0 mg, Once daily, Up to 52 weeks
16167228|NCT01646320|Drug|Saxagliptin|Tablets, Oral, 5 mg, Once daily, Up to 52 weeks
16167229|NCT01646320|Drug|Metformin immediate release (IR)|Tablets, Oral, ≥ 1500 mg, Twice daily, Up to 52 weeks
16167230|NCT01646307|Drug|Atorvastatin|
16167231|NCT01646307|Drug|Rosuvastatin|
16167232|NCT01646294|Drug|YM178 modified release (OCAS)|oral
16167233|NCT01646294|Drug|YM178 immediate release (IR)|oral
16167234|NCT01646281|Drug|Vernakalant|10-minute infusion of 3 mg/kg vernakalant, followed by a 15 minute observation period. If the patient is still in atrial fibrillation, an additional 10-minute infusion of 2 mg/kg vernakalant will be given.
16167235|NCT01646281|Drug|Flecainide|10-minute infusion of 2 mg/kg (maximal 150 mg)
16167236|NCT01646268|Drug|Rotigotine|"Transdermal Patch
~Content:
~2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)
~For early-stage Parkinson's disease, receive Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 24 week maintenance period"
16167237|NCT01646268|Drug|Placebo Patch|"Transdermal Patch
~Size:
~10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2
~Subjects randomized to placebo will receive matching placebo patches"
16167238|NCT01646255|Drug|Rotigotine|"Transdermal Patch
~Content:
~4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)
~For advanced-stage Parkinson's Disease, subjects received Rotigotine patches in escalating weekly dose (starting with daily doses 4 mg/24 h to 16 mg/24 h) for a maximum 7-week Titration Period, then 12 week maintenance period"
16167239|NCT01646255|Drug|Placebo Patch|"Transdermal Patch
~Size:
~20 cm^2, 30 cm^2, 40 cm^2
~Subjects randomized to placebo received matching placebo patches"
16167240|NCT01646255|Drug|L-dopa|Subject must be on a stable dose of L-dopa (either short-acting or sustained release [in combination with benserazide or carbidopa]) of at least 200 mg/day, administered in at least 2 intakes, for at least 28 days prior to Baseline.
16167241|NCT01646242|Procedure|removal of eligible polyps using cold snare polypectomy technique|Snare polypectomy using a mini (10 mm open diameter) size electrosurgical snare without application of electrocautery
16167245|NCT01646216|Behavioral|Split belt treadmill|A split belt treadmill is like a typical treadmill that is seen in the gym, except that this treadmill has two belts that move instead of just one. One leg goes on one belt and the other leg uses the other belt. The belt speeds can be set to move at the same speed, making this treadmill similar to any regular treadmill, but, belt speeds can also be set so that one belt moves a little faster than the other. The belts are never set at a running or jogging speed, only a self-paced walking speed regardless of whether the belts are both going the same or slightly different speeds.
16167246|NCT01646203|Biological|IMC-TR1|Administered intravenously
16167247|NCT01646190|Dietary Supplement|Preoperative Carbohydrate load|oral intake in the evening before surgery and 2-3h before intubation
16167248|NCT01646190|Procedure|individualized i.v fluids therapy|by Transoesophageal aortic US-Doppler done intraoperatively
16167249|NCT01646190|Behavioral|Fasting state after midnight|No preoperative glucose load
16167250|NCT01646190|Behavioral|No Nasogastric tube postoperatively|Withdrawal after complete awakening in operating room
16167251|NCT01646190|Behavioral|urinary catheter removal|at POD 1
16167252|NCT01646190|Behavioral|Oral liquids|0.3-0.5L oral liquids at 6h postoperatively on POD 0
16167253|NCT01646190|Behavioral|Stimulation of inspirex utilization|using 6-8 times/day to prevent pulmonary atelectasis
16167254|NCT01646190|Behavioral|Mobilization|First active mobilization 6h after surgery (2h on chair or 45° sitting in bed), >4h out of bed on POD1, >6h on POD2, complete at POD3
16167255|NCT01646190|Other|Preanesthetic medication|Preanesthetic oral medication before surgery
16167256|NCT01646177|Drug|Placebo|Administered SC
16167257|NCT01646177|Drug|50 mg etanercept|Administered SC
16167258|NCT01646177|Drug|80 mg ixekizumab|Administered SC
16167259|NCT01646151|Drug|Bimatoprost|Bimatoprost-containing eye drops administered in the affected eye(s) at a dose determined by the physician in accordance with standard of care for up to 12 weeks.
16167260|NCT01646138|Biological|Ca/04/2009/H1N1 Vero Grown Challenge Virus|The human challenge virus will be administered intranasally to each participant using a nasal sprayer. A total volume of up to 1 mL of virus will be administered.
16167261|NCT01646125|Drug|AUY922|AUY922 was to be given by i.v. once weekly at 70 mg/m2 until disease progression, death or any other reason for discontinuation from study treatment.
16167262|NCT01646125|Drug|Docetaxel|Docetaxel was to be given i.v. once every 3 weeks at 75 mg/m2 until progression or unacceptable toxicity
16167263|NCT01646125|Drug|Pemetrexed|Pemetrexed was to be given once every 3 weeks at 500 mg/m2 until progression or unacceptable toxicity
16167264|NCT01646099|Behavioral|Internet-based sun protection education|Prior to summer, KTRs who agree to participate will receive a text message with their access code to the Internet intervention to access from their homes on a personal device. After online completion of baseline assessments, participants will be randomized to receive the intervention or general skin care information (control). Following the initial use, the participants may revisit the Internet intervention on a personal device or at the doctor's office on a tablet PC. Over the next 6 weeks, sun protection text reminders will be sent to intervention KTRs' cell phones and they will respond that they read the message. Control participants will receive text messages about general skin care.
16167265|NCT01646086|Behavioral|12 month behavioral weight loss intervention|The intervention for all groups will follow a standard behavioral weight loss protocol. Participants will meet in groups of up to 20 persons; groups will meet weekly for the first six months, then biweekly for two months and monthly for the remaining four months of the 12-month treatment period. Session content will be centered on behavioral goal setting and attention to caloric intake and physical activity. Participants will be asked to keep daily diet and physical activity logs.
16167266|NCT01646073|Biological|Adalimumab|adalimumab eow
16167267|NCT01646073|Biological|placebo|placebo
16167268|NCT01646060|Device|CM-1500|Blood Volume Monitor
16167269|NCT01646047|Dietary Supplement|multi-component nutritional supplement capsules|two capsules containing nutritional supplements per day for 6 months (vitamin C, mixed tocopherols/tocotrienols, vitamin D, fish oil, lutein, zeaxanthin, pine bark extract, benfotiamine, green tea extract, curcumin)
16167270|NCT01646047|Dietary Supplement|multi-component dietary supplement|placebo capsules
16167271|NCT01646034|Drug|carboplatin, thiotepa, and cyclophosphamide|tandem intermediate-dose alkylating therapy: carboplatin 800 mg/m2, thiotepa 240 mg/m2, and cyclophosphamide 3000 mg/m2) with PBPC-reinfusion.
16167272|NCT01646034|Drug|chemotherapy (docetaxel, doxorubicin, cyclofosfamide, carboplatin, paclitaxel, gemcitabine)|"chemotherapy naïve;three cycles of docetaxel, doxorubicin, and cyclofosfamide
~chemotherapy naïve;1 cycle of dose-dense Adriamycin and cyclophosphamide followed by 4 cycles of carboplatin and paclitaxel
~previously received anthracyclines without taxanes;three cycles of carboplatin and paclitaxel
~previously received anthracyclines and taxanes;three cycles of carboplatin and gemcitabine"
16167273|NCT01646021|Drug|Ibrutinib|560 mg once daily continuous (without interruption) by mouth for 21-day cycles
16167274|NCT01646021|Drug|Temsirolimus|175 mg once daily intravenous infusion on Days 1, 8, 15 of the first cycle followed by 75 mg on Days 1, 8, 15 of each 21-day cycle
16167275|NCT01646008|Other|To measure carbon dioxide by capnography and arterial blood|Three times per day will be measured exhaled carbon dioxide and obtained in arterial blood sample.
16167276|NCT01646008|Other|to measure carbon dioxide by capnography and arterial blood|three times per day we will obtained arterial blood samples and measurements of carbon dioxide by capnography
16167277|NCT01645995|Dietary Supplement|Reformulated products|Subjects were asked to supplement their habitual diet with reformulated sugar-reduced products for 8 weeks. Subjects were provided with reformulated beverages, sauces, condiments and snacks. They were asked to consume a minimum of 1 drink + 1 food portion intervention supplement daily, in exchange for habitually eaten equivalent foods.
16167278|NCT01645995|Dietary Supplement|Conventional products|Subjects were asked to supplement their habitual diet with conventional sugar products for 8 weeks. Subjects were provided with conventional beverages, sauces, condiments and snacks. They were asked to consume a minimum of 1 drink + 1 food portion intervention supplement daily, in exchange for habitually eaten equivalent foods.
16167279|NCT01645943|Procedure|Coronary angiogram|Routine coronary angiogram and revascularization if indicated
16167280|NCT01645930|Drug|Ixazomib|Ixazomib capsules
16167281|NCT01645930|Drug|Lenalidomide|Lenalidomide capsules
16167286|NCT01645904|Behavioral|Audiotaped Interview|"Group 2: Patients provide feedback regarding initial version of My Family Garden website.
~Group 3: Patients provide feedback regarding final version of My Family Garden website."
16167287|NCT01645904|Behavioral|WAMMI Inventory|Patients complete Website Analysis and MeasureMent Inventory. This visit should take about 90 minutes to complete.
16167288|NCT01645891|Device|CDO electrochemical tissue oxygenation system|The TransCu O2® device is a non-invasive, electrochemical tissue oxygenation system intended for use with lower-cost wound dressings for the treatment of chronic wounds such as diabetic foot ulcers, venous leg ulcers, pressure ulcers and other skin wounds through the continuous diffusion of oxygen (CDO). The goal of CDO therapy is to continuously supply pure oxygen to an oxygen-compromised wound to aid in wound healing
16167289|NCT01645891|Device|Moist Wound Therapy|Moist Wound Therapy in combination with sham or deactivated device
16167290|NCT01645878|Behavioral|hands on|in hands on group it was instructed by direct help of instructor, mothers could ask questions and if necessary it was done again by researcher.
16167291|NCT01645878|Behavioral|hands off|In hands off group, was instructed by pictures, if mothers had questions, they could watch the pictures again
16167292|NCT01645878|Behavioral|routin breast feeding education|
16167293|NCT01645865|Behavioral|Control|Health facilities where PMTCT services are available in the traditional clinical setting with HIV testing and counseling, PMTCT support, and enrollment in care and treatment.
16167294|NCT01645865|Behavioral|Intervention|In addition to the 'Standard of Care', HIV-infected pregnant women and male partners within the PMTCT program are engaged in multi-directional mobile communication for PMTCT promotion with health care providers.
16167295|NCT01645852|Dietary Supplement|Optifast 800|Five units of Optifast 800 plus an unlimited volume of calorie-free fluids per day for one week prior to hepatic resection.
16167296|NCT01645839|Drug|Liposomal Cytarabine|50mg (5 mL) by slow intrathecal injection (1-5 minutes) directly into the cerebrospinal fluid (CSF) via a ventricular catheter directly into the lumbar sac during a lumbar puncture.
16167297|NCT01645826|Drug|Diltiazem Hydrochloride|The study agent will be diltiazem and will start at 60 mg po BID then titrated up very two weeks until at a maximum maintenance dose of 180mg po BID for six weeks.
16167298|NCT01645826|Drug|Sugar Pill|The placebo group of patients will be treated with sugar pill PO bid and return every two weeks for next titration dose (actually will be an unchanged concentration).
16167299|NCT01645800|Drug|Lysozyme hydrochloride|LYL 90mg capsule: Three times daily for 52 weeks.
16167300|NCT01645800|Drug|Placebo|Matching Placebo capsule: Three times daily for 52 weeks.
16167301|NCT01645787|Drug|4-aminopyridine|10 mg/twice daily
16167302|NCT01645787|Drug|Placebo|Crossover study involving one trial with sugar pill (placebo)
16167303|NCT01645774|Procedure|10s injections duration|10s injections duration
16167304|NCT01645774|Procedure|10s injection duration and waiting 10s before withdrawing the needle|10s injection duration and waiting 10s before withdrawing the needle
16167305|NCT01645774|Procedure|15s injection duration and waiting 5s before withdrawing the needle|15s injection duration and waiting 5s before withdrawing the needle
16167306|NCT01645774|Procedure|5s injection duration and waiting 15s before withdrawing the needle|5s injection duration and waiting 15s before withdrawing the needle
16167307|NCT01645761|Drug|Endonase|PPI- based triple therapy with endonase
16167308|NCT01645748|Drug|S-1|S-1 is an oral fluoropyrimidine derivative, based on the concept of biochemical modulation. It consists in a molar ratio of 1:0.4:1: tegafur, a prodrug that is slowly metabolized to 5-fluorouracil; gimeracil, which reversibly inhibits dihydropyrimidine dehydrogenase. In patients with advanced gastric cancer, phase I study of S-1, docetaxel and cisplatin combination chemotherapy was reported and the recommended doses were 40mg/m2 bid (D1-D14), 60mg/m2 (D1) and 60mg/m2 (D1), respectively.
16167309|NCT01645748|Drug|S-1|Chemotherapy was comprised of docetaxel 30 mg/m2 on days 1 and 8, cisplatin 60 mg/m2 on day 1, and S-1 70 mg/m2 on days 1 to 14, with the regimen repeated every 21 days
16167310|NCT01645748|Drug|S-1|In patients with advanced gastric cancer, phase I study of S-1, docetaxel and cisplatin combination chemotherapy was reported and the recommended doses were 40mg/m2 bid (D1-D14), 60mg/m2 (D1) and 60mg/m2 (D1), respectively. Another phase II study of TPS as induction chemotherapy for locally advanced HNSCC was determined to be 70/70/60 mg∙m2/d every 3 weeks. However, the rate of grade 3-4 neutropenia was 75% at this recommended dose. To reduce the hematologic toxicities, we used the docetaxel weekly. Therefore following regimen was evaluated in this study; docetaxel 30 mg/m2 (D1, D8), cisplatin 60mg/m2 (D1), S-1 70mg/m2 (D1-D14) every 3 weeks.
16167311|NCT01645735|Drug|Ceftaroline fosamil|Ceftaroline fosamil 600 mg IV over 60 minutes q8h; treatment duration 5 to 14 days
16167312|NCT01645735|Drug|Ceftriaxone plus vancomycin|Ceftriaxone 2g IV over 30 minutes q24h plus vancomycin 15 mg/kg IV q12h initially and then dose adjusted based on trough concentrations; treatment duration 5 to 14 days
16167313|NCT01645722|Procedure|Procedure/Surgery: Enriched Fat grafting|Fat grafting is a minimally invasive clinical procedure that has been widely used by plastic surgeons within reconstructive surgery for many years. Fat tissue to be used for grafting is harvested (usually from abdomen or thighs) in the operating room. The fat tissue is then sterilely centrifuged and allowed to decant before separating the fluid and oil layers from the fat tissue fraction. The aspirated fat is then injected into the amputation stump.In this study, we will concentrate the adipose stromal cells (ASCs) in the fat graft material to assess whether this modification will increase fat graft retention over time. The volume retention in areas treated with ASC concentrated fat grafts will be compared with regions treated with standard fat grafts in the same patient.
16167314|NCT01645709|Drug|Verapamil|
16167315|NCT01645709|Drug|Placebo|
16167316|NCT01645696|Device|BD CGM with Outer Layer|continuous (every 2 minutes) subcutaneous glucose monitoring for 72 hours.
16167317|NCT01645696|Device|BD CGM without Outer Layer|continuous (every 2 minutes) subcutaneous glucose monitoring over 72 hours.
16167318|NCT01645696|Device|Medtronic iPro2 Professional CGM|continuous subcutaneous glucose monitoring for 72 hours
16167319|NCT01645566|Behavioral|instruction|"instructions about focusing on relevant task elements by posing two task-focusing questions (what is the patient's condition?, what immediate action is needed?) when feeling overwhelmed by stress (intervention-group)"
16167320|NCT01645475|Drug|Desmopressin lyophilisate (Melt)|Patient receives Desmopressin lyophilisate (Melt).
16167321|NCT01645449|Drug|Atorvastatin Calcium Tablets, 80 mg|Atorvastatin Calcium Tablets, 80 of Dr. Reddy's Laboratories Limited
16167322|NCT01645436|Other|exercise training|The intervention group will participate in combined inpatient physical training (aerobic + strength) over neoadjuvant chemotherapy. The intervention will include three weekly exercise sessions of 60-90 minutes, and will be held in child's room or in a pediatric gym specifically enabled on the aforementioned hospital, depending on the children's health status.
16167323|NCT01645423|Drug|Atorvastatin Calcium Tablets, 80 mg|Atorvastatin Calcium Tablets, 80 of Dr. Reddy's Laboratories Limited
16167324|NCT01645410|Drug|Atorvastatin Calcium Tablets, 40 mg|Atorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Laboratories Limited
16167325|NCT01645384|Drug|Atorvastatin Calcium Tablets, 40 mg|Atorvastatin Calcium Tablets, 40 mg of Dr. Reddy's Laboratories Limited
16167326|NCT01645358|Device|Helmet (Starmed)|The helmet is a kind of interface similar to a hood to deliver NIV
16167327|NCT01645358|Device|Total Face mask (Respironics)|"The total face mask is the classical interface for NIV delivery"
16167328|NCT01645345|Device|Alma Lasers Accent RF Pixel handpiece|Treatment with fractionated RF Pixel device
16167329|NCT01645332|Drug|Placebo of DLBS3233|Placebo of DLBS3233 once daily for 12 weeks
16167330|NCT01645332|Drug|DLBS3233|100 mg DLBS3233 once daily for 12 weeks
16167331|NCT01645332|Other|Lifestyle modification|Each study subject will be provided with and instructed to follow a lifestyle modification (particularly regarding dietary advice and exercise) during the subject's participation in the study.
16167332|NCT01645306|Drug|Revacept|single intravenous injection
16167333|NCT01645306|Drug|Placebo|single intravenous injection
16167334|NCT01645293|Genetic|Genetically modified T cells # 1138|
16167335|NCT01645280|Drug|Placebo + methotrexate (MTX) (Group 1)|Placebo: form = solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose)
16167336|NCT01645280|Drug|Ustekinumab + MTX (Group 2)|Ustekinumab: type = exact number, unit = mg, number = 90, form = solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose)
16167337|NCT01645280|Drug|Ustekinumab + MTX (Group 3)|Ustekinumab: type = exact number, unit = mg, number = 90, form = solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 12 weeks (Weeks 16 and 28) + MTX (pre-study dose)
16167338|NCT01645280|Drug|CNTO 1959 + MTX (Group 4)|CNTO 1959: type = exact number, unit = mg, number = 200, form = powder for solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28) + MTX (pre-study dose)
16167339|NCT01645280|Drug|CNTO 1959 + MTX (Group 5)|CNTO 1959: type = exact number, unit = mg, number = 50, form = powder for solution for injection, route = subcutaneous use, at Weeks 0, 4, then every 8 weeks (Weeks 12, 20, and 28)+ MTX (pre-study dose)
16167340|NCT01645267|Procedure|Hydroxyapatite|Use of artifical bonegraft material
16167341|NCT01645254|Drug|Argemone mexicana|30g, the powder decoction 2 times a day for 14 days
16167342|NCT01645241|Drug|gonadotropins plus GnRH antagonists|
16167343|NCT01645241|Drug|ganirelix|
16167344|NCT01645228|Radiation|coronary calcium score measurement|
16167345|NCT01645228|Biological|high sensitivity C reactive protein measurement|
16167346|NCT01645228|Procedure|ankle brachial index measurement|
16167347|NCT01645215|Drug|Fruquintinib|Fruquintinib is a capsule in the form of 0.25mg , 1mg and 5mg, oral, once a day.
16167348|NCT01645202|Procedure|Transcatheter Aortic Valve Implantation (TAVI)|Comparison of different types of valves
16167349|NCT01645189|Biological|Hunterase|once weekly, 0.5mg/kg IV infusion
16167350|NCT01645176|Drug|Hydroxychloroquine/Atorvastatin|Hydroxychloroquine 200-600 mg /day Atorvastatin 40 mg/day
16167351|NCT01645163|Behavioral|Counselling using mobile phones|Feasibility and acceptability of using mobile phones to improve complementary feeding practices.
16167352|NCT01645150|Behavioral|Progressive strength training|12 weeks of supervised progressive strength training
16167353|NCT01645137|Other|osteopathic manipulative treatment|Patients from this group received osteopathic treatments twice a week for the entire length of stay in the unit.
16167354|NCT01645137|Other|Usual care|Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.
16167355|NCT01645124|Drug|Hydroxyurea|
16167356|NCT01645124|Procedure|Phlebotomy|
16167357|NCT01645111|Drug|Clevidipine|
16167358|NCT01645098|Drug|Ketamine|1 mg/kg IV, additional doses of 0.5 mg/kg as needed
16167359|NCT01645098|Drug|Dexmedetomidine|0.5 mcg/kg/hr IV
16167360|NCT01645085|Drug|MCC-based 13% drug loaded tablets|50mg tablets, dosed as 2 tablets (100mg total)
16167361|NCT01645085|Drug|Mannitol-based 38% drug-loaded tablet|One 100mg tablet
16167362|NCT01645085|Drug|MCC-based 13% drug loaded tablets|3 tablets (150mg total)
16167363|NCT01645085|Drug|Mannitol-based 38% drug-loaded tablet|One 150 mg tablet
16167364|NCT01645072|Other|Low glycemic index diet|Diet modification in addition to ongoing anti epileptic drug treatment. Medium and high-GI carbohydrates (GI >55) will be eliminated from the diet and only food items with low glycemic index (GI <55) will be allowed. Parent will be given a list of low glycemic index food items. They will also be given a list of food items (medium and high glycemic index) which should be avoided.
16167365|NCT01645072|Other|Control group|The ongoing anti epileptic drug treatment will be continued without change.
16167366|NCT01645046|Drug|Coenzyme A|Coenzyme A 200mg per day.
16167367|NCT01645046|Drug|Coenzyme A|Coenzyme A 400mg per day.
16167368|NCT01645046|Drug|Placebo|Capsule without coenzyme A.
16167369|NCT01645033|Other|computerized Cognitive Behavioral Therapy (CBT)|Standard treatment (as described in TAU) plus a short session using a computer program containing CBT to understand risks related to sexual and other behaviors and how those risks relate to spread of infections.
16167446|NCT01644461|Other|Autologous Human Platelet Lysate|All subjects will receive a single injection of Autologous Human Platelet Lysate in the nasolabial region
16167447|NCT01644448|Other|Autologous Human Platelet Lysate|Subjects will receive one dose of 5 ml of HPL with simultaneous micro-needling on day 2
16167448|NCT01644448|Other|Standard Therapy|Topical Applications as directed by the investigator
16167370|NCT01645033|Other|Treatment as Usual (TAU)|"This is the infectious disease orientation that would normally be received at this clinic to address risky behavior. This orientation generally includes individual and group therapy sessions that discuss behaviors and the resulting risk of sexually or drug-related infections (for example: use of a condom). Sessions will generally include items such as:
~Teaching about the treatment program
~Teaching important ideas about sexual behaviors risks
~Increasing knowledge about specific sexually transmitted diseases
~Discussions of ways to reduce or minimize spread of diseases related to drug use [for example, Hepatitis and Human Immunodeficiency virus (HIV, the virus responsible for causing AIDS)]"
16167371|NCT01644994|Combination Product|intracavitary cisplatin-fibrin|single dose, local intracavitary application of cisplatin-fibrin after pleurectomy/decortication
16167372|NCT01644981|Other|blood sampling|blood sampling
16167373|NCT01644968|Drug|Cohort 1 anti-OX40|0.1 mg/kg anti-OX40 on days 1, 3, and 5
16167374|NCT01644968|Drug|Cohort 2 anti-OX40|.4 mg/kg anti-OX40 on days 1, 3, and 5
16167375|NCT01644968|Drug|Cohort 3 anti-OX40|2.0 mg/kg anti-OX40 on days 1, 3, and 5
16167376|NCT01644968|Biological|Tetanus Day 29|Tetanus toxoid vaccine 0.5ml (5 LF/ml tetanus toxoid)on Day 29
16167377|NCT01644968|Biological|Tetanus Day 1|Tetanus toxoid vaccine 0.5ml (5 LF/ml tetanus toxoid)on Day 1.
16167378|NCT01644968|Biological|KLH Day 1|1 mg KLH in 1 cc diluent subcutaneously on Day 1.
16167379|NCT01644968|Biological|KLH Day 29|1 mg KLC in 1 cc diluent by subcutaneous injection on Day 29.
16167380|NCT01644955|Drug|carboplatin|Carboplatin in a volume of 54 ml will be administered intracerebrally by convection enhanced delivery
16167381|NCT01644955|Procedure|Surgery|Patients will undergo surgery, which includes tumor resection and catheter placement, in the operating room.
16167382|NCT01644942|Other|Lipid accumulation analysis|The lipid accumulation will be assessed with muscular biopsies.
16167383|NCT01644929|Procedure|transcranial direct current stimulation (tDCS)|Anodal tDCS of the ipsilesional motor cortex and cathodal tDCS of contralesional motor cortex (1.5 mA, 30 minutes) for 15 days during three weeks, then sham stimulation for 30 seconds on 15 days during 3 weeks
16167384|NCT01644929|Procedure|Sham stimulation, then tDCS|Sham stimulation for 30 seconds on 15 days during 3 weeks, then anodal tDCS of the ipsilesional motor cortex and cathodal tDCS of contralesional motor cortex (1.5 mA, 30 minutes) for 15 days during three weeks
16167385|NCT01644929|Procedure|Sham stimulation|Sham stimulation for 30 seconds on 15 days during 6 weeks
16167386|NCT01644916|Procedure|Integrated care|Integrated care will be provided with management of multifaceted group including, nurse educators, doctors, case manager and psychologists.
16167387|NCT01644916|Procedure|Usual control|Usual control group will be provided with usual standard procedures for management of COPD and psychiatric comorbidities.
16167388|NCT01644890|Drug|NK105|IV, Weekly
16167389|NCT01644890|Drug|Paclitaxel|IV, Weekly
16167390|NCT01644877|Drug|DAS181 dry powder, formulation F02|
16167391|NCT01644877|Drug|Lactose Placebo|
16167392|NCT01644864|Drug|0.375% ROPIVACAINE|
16167393|NCT01644864|Drug|placebo|
16167394|NCT01644851|Behavioral|Executive function training|Computer-based training in executive functions, administered via www.lumosity.com website.
16167395|NCT01644838|Drug|Hyoscine|The samples were randomly allocated to inject of 20 mg of hyoscineIM in dilatation 3-5cm.
16167396|NCT01644838|Drug|Promethazine|The samples were randomly allocated to inject of 25 mg of promethazine IM in dilatation 3-5cm.
16167397|NCT01644825|Drug|paclitaxel|80 mg/m2 IV days 1, 8, 15 every 28 days
16167398|NCT01644825|Drug|pazopanib|orally, 800 mg orally daily
16167399|NCT01644812|Behavioral|Aerobic exercise|
16167400|NCT01644812|Behavioral|Stretching|
16167401|NCT01644799|Drug|idelalisib|oral
16167402|NCT01644799|Drug|lenalidomide|oral
16167403|NCT01644773|Drug|Crizotinib|"Starting dose level:
~Initial Treatment Plan: 130 mg/m^2 per dose
~Modified Treatment Plan per Amendment 1.0: 165 mg/m^2 per dose
~The dose of a single agent will be increased by approximately 30% in each subsequent cohort until the MTD of this combination is reached.
~The doses of each agent will not exceed their single-agent MTD already determined for children with recurrent solid tumors.
~Cycle 1 (28 days): once a day for 28 days
~Cycles 2-26 (28 days each): once a day"
16167404|NCT01644773|Drug|Dasatinib|"Starting dose level: 50 mg/m^2 per dose
~The dose of a single agent will be increased by approximately 30% in each subsequent cohort until the MTD of this combination is reached.
~The doses of each agent will not exceed their single-agent MTD already determined for children with recurrent solid tumors.
~Cycle 1 (28 days): starting on day 3, once a day for 28 days
~Cycles 2-26 (28 days each): once a day"
16167405|NCT01644760|Procedure|Ultrasounds with controlled breathing|The patient will have cardiac, abdominal and thoracic ultrasounds with controlled and monitored inspiratory effort. This gesture takes about 40 minutes.
16167406|NCT01644747|Device|transcranial Direct Current Stimulation (tDCS) (Eldith DC NeuroConn Stimulator)|After locating the left DLPFC, ttt with active anodal tDCS with a current of 2 mA or sham over the left DLPFC will be directed by 30-minute session. Treatment will occur 2 sessions per day during 5 days per week. Subjects will be monitored during tDCS for any side effects or adverse events.
16167407|NCT01644734|Drug|Spiriva HandiHaler|
16167408|NCT01644721|Biological|Early measles vaccine|Standard Edmonston-Zagreb measles vaccine
16167409|NCT01644708|Behavioral|Self empowerment|"1. Group meeting, introducing the method and the assessment tools
~Self-empowerment,
~Handing over the journal,
~Questionnaire about emotional states and motivations for losing weight and for change.
~The group meetings, lasting one hour and a half, will take place every week, always on the same day and at the same time, for one year. During each meeting the participant weighs himself and he notes his weight down in his journal."
16167449|NCT01644435|Biological|Autologous Human Platelet Lysate|Subjects will receive a single injection of Autologous Human Platelet Lysate for acne scarring
16167450|NCT01644435|Biological|Autologous Human Platelet Lysate|Subjects will receive two injections of Autologous Human Platelet Lysate at an interval of one month for acne scarring
16167451|NCT01644422|Biological|Autologous Human Platelet Lysate|Study arm A subjects will receive hair follicles transplants that are dipped in HPL before transplant
16167485|NCT01644149|Biological|2011-2012 Fluzone trivalent inactivated influenza vaccine|
16167902|NCT01641224|Drug|Tuckahoe|Tuckahoe (15g)
16167410|NCT01644695|Procedure|Bony Anchoring Reinforcement System|Abdominal exposure was obtained via a lower horizontal incision, a vertical incision, or through a combination horizontal/vertical (ie fleur-di-lis) pattern. Exploratory laparotomy, lysis of intra-abdominal adhesions with hernia sac excision was performed prior to fascial closure. Primary closure of the abdominal fascia was performed with a combination of components separation and placement of biologic mesh over the fascial incision line in onlay fashion. Typically three bone anchors were used to secure the synthetic mesh at the pubic symphysis and two bone anchors to the ASIS bilaterally. The superior aspect of the marlex mesh was sutured to fascia avoiding any incorporation of the costal perichondrium. Quilting sutures were used to secure the mesh to the rest of the abdominal fascia.
16167411|NCT01644682|Other|IWFPL|Indoor house walls and floors will be plastered with lime (a traditional method known in the study areas) including treatment of outdoor breeding places with lime and bleaching powder to inhibit sandfly breeding
16167412|NCT01644682|Other|IDWL|Install durable wall lining containing deltamethrin to kill immature stage and as well as adult sand flies
16167413|NCT01644682|Other|ITN|Impregnation of existing bed-nets available in the community with slow release insecticide, deltamethrin
16167414|NCT01644669|Radiation|Intra-operative Radiation Therapy - IORT|Single dose of 20 Gy
16167415|NCT01644656|Device|ARFI ultrasound|ARFI imaging of the liver and spleen will be performed immediately before transjugular liver biopsy and HVPG procedures
16167416|NCT01644643|Drug|Ceftazidime - Avibactam ( CAZ-AVI)|Ceftazidime 2000 mg and 500 mg of avibactam Patients randomized to receive CAZ-AVI will receive an infusion of CAZ-AVI (2000 mg ceftazidime and 500 mg avibactam) every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 120 minutes
16167417|NCT01644643|Drug|Best Available Therapy|Patients randomized to receive Best Available Therapy will receive the best available standard of care (SOC) anti-infective therapy for their infection administered in accord with approved local label recommendation
16167418|NCT01644643|Drug|Metronidazole|Anti-infective, 500 mg (cIAI only) Patients randomized to receive CAZ-AVI for cIAI will also receive metronidazole (500 mg) administered by IV infusion in a volume of 100 mL at a constant rate over 60 minutes immediately following the CAZ-AVI infusion
16167419|NCT01644630|Procedure|Cemented crowns|"The final lithium disilicate crowns will be cemented with an adhesive cement after tightening the abutments with the torque indicated by the manufacturer and closing the screw access hole with white guttapercha. The abutment will be cleaned with ethanol. A retraction cord will be placed for cementation if indicated. The crown will be etched with hydrofluoric acid and subsequently silanized. A sufficient amount of cement will be filled in the crown without creating major excesses. When the crown is seated correctly, the cement will be light-cured for a few seconds to facilitate the removal of the now hard excess cement.
~- Excess cement will be meticulously removed with a carbon scaler. The removal of all excess cement will be checked with an X-ray and by visual and tactile inspection."
16167420|NCT01644630|Procedure|Screw-retained crowns|The screw-retained crowns will be inserted and tightened with the torque indicated by the manufacturer. The screw access hole will to be closed with white guttapercha and a composite filling (Filtek, 3M ESPE).
16167421|NCT01644617|Drug|Placebo|Placebo rapidly dissolving tablets administered sublingually once daily
16167422|NCT01644617|Drug|MK-8237 6 DU|MK-8237 6 DU rapidly dissolving tablets administered sublingually once daily
16167423|NCT01644617|Drug|MK-8237 12 DU|MK-8237 12 DU rapidly dissolving tablets administered sublingually once daily
16167424|NCT01644604|Device|MDT-2211 Renal Denervation System|A percutaneous system that delivers radiofrequency (RF) energy through the luminal surface of the renal artery.
16167425|NCT01644591|Other|Quality-of-Life Assessment|Ancillary studies
16167426|NCT01644591|Other|Questionnaire Administration|Ancillary studies
16167427|NCT01644591|Radiation|Stereotactic Radiosurgery|Undergo SRS
16167428|NCT01644578|Procedure|Real-time imaging for MRI-guided procedures|Real-time imaging for improvement of workflow in MRI-guided procedures
16167429|NCT01644565|Biological|Recombinant fimbrial adhesin dsc14CfaE-sCTA2/LTB5|
16167430|NCT01644565|Biological|Recombinant fimbrial adhesin dscCfaE|
16167431|NCT01644565|Biological|Modified E. coli heat labile enterotoxin LTR192G|
16167432|NCT01644539|Dietary Supplement|Water with guar gum - Non Caloric|Infusion 500 ml of water with 3 gram of guar gum through a naso-gastric tube directly into stomach during a fMRI scan.
16167433|NCT01644539|Dietary Supplement|Chocolate milk - Oral Caloric|Ingestion of 500 ml of commercially available chocolate milk (Per 100mL; energy content of 354 kJ, 84 kcal, 3.5 g proteins, 12 g mono and disaccharide, 2.5 fat g, 0.5 g fibers) through a tube in the mouth during a fmri scan.
16167434|NCT01644539|Dietary Supplement|Chocolate milk - Intra Gastric Caloric|Infusion of 500 ml of commercially available chocolate milk (Per 100mL; energy content of 354 kJ, 84 kcal, 3.5 g proteins, 12 g mono and disaccharide, 2.5 fat g, 0.5 g fibers) through a naso-gastric tube directly into stomach during a fMRI scan.
16167435|NCT01644526|Device|Hemoaccess Valve System|Device that allows blood to selectively flow into an arteriovenous graft to provide vascular access for dialysis then turn off the flow of blood to the graft in between dialysis sessions.
16167436|NCT01644500|Drug|Dulaglutide|Administered SC
16167437|NCT01644500|Drug|Glimepiride|Administered orally
16167438|NCT01644500|Drug|Placebo as Capsules|Placebo for glimepiride is administered orally as one to three capsules daily.
16167439|NCT01644500|Drug|Placebo as SC Injection|Placebo for dulaglutide is administered as one SC injection.
16167440|NCT01644487|Device|self-expanding nitinol stent|A group of patients who will undergo subsequent primary stenting following successful conventional balloon angioplasty
16167441|NCT01644487|Device|balloon angioplasty|A group of patients who will undergo routine conventional balloon angioplasty alone without stenting
16167442|NCT01644474|Drug|Alirocumab|1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using the autoinjector.
16167443|NCT01644474|Drug|Ezetimibe|One over-encapsulated tablet orally once daily at approximately the same time of the day with or without food.
16167444|NCT01644474|Drug|Placebo (for Alirocumab)|1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self--injection or by another designated person using the autoinjector.
16167445|NCT01644474|Drug|Placebo (for Ezetimibe)|One capsule orally once daily at approximately the same time of the day with or without food..
16167452|NCT01644422|Biological|Autologous Human Platelet Lysate|Study arm B subjects will receive hair follicles transplants that are dipped in HPL before transplant; followed by one HPL injection
16167453|NCT01644422|Other|Standard hair follicle transplant|Control arm subject will receive Standard hair follicle transplant
16167454|NCT01644396|Biological|Adalimumab|
16167455|NCT01644383|Behavioral|logotherapy|Logotherapy is therapy during which the interaction between the therapist and the client centres on the topic of meaning. The problems that the clients experience are presented to the client as inseparable parts of his everyday life. The client is then challenged to discover his/her meaning and to take responsibility in facing up to his/her problem. This approach is aimed at helping the client to deal and understand what his /her existences entail.
16167456|NCT01644370|Drug|HAART|as per Thai HIV Treatment guidelines
16167457|NCT01644357|Other|Pharmaceutical care|Pharmacist intervention, focused on the optimization of drug therapy, identification and resolution of drug related problems, resulting in best asthma control and quality of life. Pharmacists document their initial and monthly follow up encounters using a specified form. An action plan for self management of these patients was prepared and discussed aiming at early identification and treatment of an exacerbation episode. Meetings will be held weekly with intervention team to discuss action plan and measure of outcomes of all problems identified.
16167458|NCT01644344|Other|No-Xray|Treatment group: these patients will not have routine post-operative in hospital radiographs, or radiographs in clinic at two weeks. After examining the patient, the surgeon or resident can order radiographs if required at any time. The decision will be made based on patient complaints of increased pain, appearance of abuse of the splint or cast suggesting lack of compliance or visible clinical deformity of the limb. The reason leading to radiographs will be documented by the ordering physician. If radiographs are ordered based on a wound complication, this will be specifically documented. Radiographic findings will be documented on a form identical to that used for the control group.
16167459|NCT01644344|Other|Xray|
16167460|NCT01644331|Drug|Tolvaptan|IV furosemide plusTolvaptan (given at 0, 24 and 48 hours)
16167461|NCT01644331|Drug|Placebo|IV furosemide plus oral placebo (given at 0, 24 and 48 hours)
16167462|NCT01644292|Other|EPIC WheelS|EPIC WheelS is a user-centred program for wheelchair skills training that combines two structured 1-hour sessions with an expert trainer and four weeks of self-directed practice and training in the natural (home) environment.
16167463|NCT01644253|Biological|20 mg/kg TRU-016 + Rituximab|"TRU-016: 10 mg/kg for first dose, all subsequent doses 20 mg/kg, IV once weekly for 8 weeks followed by 4 monthly doses
~Rituximab: 375 mg/m2 for first dose, all subsequent doses 500 mg/m2, IV once weekly for 8 weeks followed by 4 monthly doses"
16167464|NCT01644253|Biological|10 mg/kg TRU-016 + Rituximab|"TRU-016: 6 mg/kg for first dose, all subsequent doses 10 mg/kg, IV on Day 1, 8 and 15, followed by 5 monthly doses
~Rituximab: 375 mg/m2 for first dose, all subsequent doses 500 mg/m2, IV following TRU-016 schedule"
16167465|NCT01644253|Biological|TRU-016 20 mg/kg + Obinutuzumab|"TRU-016: 6 mg/kg on Day 1, 20 mg/kg on Day 8 and 15, then 20 mg/kg once a month for 5 months
~Obinutuzumab: 100 mg on Day 1, 900 mg on Day 2, 1,000 mg on Day 8 and 15, then 1,000 mg once a month for 5 months"
16167466|NCT01644253|Biological|TRU-016 6-20 mg/kg + idelalisib + rituximab|TRU-016: 6 mg/kg on Days 15-36 weekly, 10 mg/kg on Days 43 and 50, then 20 mg/kg once a month for 5 months.
16167467|NCT01644253|Biological|TRU-016 10-20 mg/kg + ibrutinib|TRU-016: Dosed weekly for 8 weeks followed by 4 monthly intravenous (IV) infusions. The first dose will be 10 mg/kg and all subsequent doses will be 20 mg/kg.
16167468|NCT01644253|Biological|TRU-016 10-20 mg/kg + bendamustine|TRU-016 dosed 10 mg/kg for the first dose and then 20 mg/kg weekly for 2 cycles, followed by dosing every other week for an additional 4 cycles (cycle = 28 days). Bendamustine (90 mg/m2 on days 2 and 3 of cycle 1 and then days 1 and 2 of cycles 2 to 6) will be infused after completion of TRU-016. If a patient is benefiting with stable disease or better, then TRU-016 may continue to be dosed every 3 weeks after the first 6 cycles; bendamustine will not be dosed beyond 6 cycles.
16167469|NCT01644240|Drug|TD-8954|Intravenous infusion
16167470|NCT01644240|Drug|Placebo - saline|Intravenous infusion
16167471|NCT01644214|Other|6 month follow up for pessary check in the clinic setting|The standard of care is considered to be pessary checks every 3 months, therefore those that are checked every 6 months will be considered to be in the intervention group.
16167472|NCT01644201|Dietary Supplement|PolyGlycopleX® - PGX®|15g or 20g total daily dose, 5g pre-mixed with liquid meal replacement and consumed twice daily, 5g supplement granules sprinkled on food and consumed once of twice daily
16167473|NCT01644201|Dietary Supplement|Rice Flour (placebo)|15g or 20g total daily dose, 5g pre-mixed with liquid meal replacement and consumed twice daily, 5g supplement granules sprinkled on food and consumed once of twice daily
16167474|NCT01644188|Drug|Alirocumab|1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using the autoinjector.
16167475|NCT01644188|Drug|Placebo (for alirocumab)|1 mL subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using the autoinjector.
16167476|NCT01644188|Drug|Ezetimibe|One over-encapsulated tablet orally once daily at approximately the same time of the day with or without food.
16167477|NCT01644188|Drug|Placebo (for ezetimibe)|One capsule once daily orally at approximately the same time of the day with or without food.
16167478|NCT01644188|Drug|Lipid Modifying Therapy (LMT)|Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose.
16167479|NCT01644175|Drug|Placebo (for alirocumab)|Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector (also known as pre-filled pen).
16167480|NCT01644175|Drug|Alirocumab|Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a disposable auto-injector (also known as pre-filled pen).
16167481|NCT01644175|Drug|Lipid-Modifying Therapy (LMT)|Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.
16167482|NCT01644162|Device|iVAPS ventilation|3 months of ventilation on iVAPS mode
16167483|NCT01644149|Device|Stratis Jet Injector|Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine
16167484|NCT01644149|Device|Needle and Syringe|Intramuscular administration of 0.5 mL of 2011-2012 Fluzone trivalent inactivated influenza vaccine
16167486|NCT01644136|Procedure|robot-assisted laparoscopic surgery|Undergo standard robotic assisted laparoscopic prostatectomy
16167487|NCT01644136|Procedure|regional lymph node dissection|Undergo pelvic lymph node dissection
16167488|NCT01644136|Device|microsphere-mediated lymphocele prevention|Undergo microsphere-mediated lymphocele prevention
16167489|NCT01644110|Drug|INCB018424/CC-4047|"Cohort 1: For patients (1-41) the starting dose of ruxolitinib in this trial is 10 mg twice daily po; pomalidomide will be administered at a permanent dose of 0.5 mg po once daily.
~Cohort 2: For patients (42-90) the starting dose of ruxolitinib in this trial is 10 mg twice daily po; the starting dose of pomalidomide is 0.5 mg po once daily."
16167490|NCT01644097|Dietary Supplement|Lactobacillus plantarum strain 299v|Given PO
16167491|NCT01644097|Dietary Supplement|Lactobacillus acidophilus probiotic|Given PO
16167492|NCT01644097|Dietary Supplement|placebo|Given PO
16167493|NCT01644097|Other|laboratory biomarker analysis|Correlative studies
16167494|NCT01644097|Other|questionnaire administration|Ancillary studies
16167495|NCT01644097|Procedure|quality-of-life assessment|Ancillary studies
16167496|NCT01644097|Dietary Supplement|Bifidobacterium lactis probiotic supplement|Given PO
16167497|NCT01644084|Drug|Hydroxyethyl starch 130/0.4|Hydroxyethyl starch 130/0.4 as a priming of cardiopulmonary bypass circuit and/or as a fluid after cardiopulmonary bypass
16167498|NCT01644084|Drug|Hydroxyethyl starch 130/0.4|Hydroxyethyl starch 130/0.4 as a priming of cardiopulmonary bypass circuit and/or as a fluid after cardiopulmonary bypass
16167499|NCT01644084|Drug|Hydroxyethyl starch 130/0.4|Hydroxyethyl starch 130/0.4 as a priming of cardiopulmonary bypass circuit and/or as a fluid after cardiopulmonary bypass
16167500|NCT01644071|Drug|cipralex|one time 10 mg, tablet
16167501|NCT01644058|Procedure|Immediate loading|
16167502|NCT01644045|Device|Teleconsultation|Teleconsultation for the EMS in acute respiratory emergencies
16167503|NCT01644032|Other|Teleconsultation|Teleconsultation between paramedics and an EMS physician
16167504|NCT01644019|Procedure|Teleconsultation|Teleconsultation of an EMS physician in cases of suspected acute stroke
16167505|NCT01644006|Procedure|Teleconsultation|Teleconsultation of an EMS physician to support the paramedics in acute coronary syndromes
16167506|NCT01643993|Other|hCG at the Time of Embryo Transfer|hCG will be included in the 20 microliters of media inserted during a mock embryo transfer immediately prior to actual embryo transfer.
16167507|NCT01643993|Other|Control|Patients will have 20 microliters of media inserted during a mock embryo transfer immediately prior to actual embryo transfer.
16167508|NCT01643980|Drug|Vaginal micronized progesterone|200 mg vaginal route per day
16167509|NCT01643980|Device|Cervical pessary|Cervical pessary certified by European Conformity (CE0482, MED/CERT ISO 9003/EN 46003;Dr Arabin, lower larger diameter 70 mm, height 30 mm,and upper smaller diameter 32 mm)
16167510|NCT01643967|Other|sunflower oil|The research subjects allocated to this treatment arm will receive Sunflower Oil supplied by Philozon. Sunflower oil should be applied once daily for 60 days, it immediately after cleansing site where the lesion is present.
16167511|NCT01643967|Other|Ozone Therapy|The research subject will receive topical and rectal insufflation of ozone three times a week on alternate days for two months or at least 12 sessions.
16167512|NCT01643954|Procedure|robotic radical prostatectomy|robotic assisted surgery
16167513|NCT01643941|Biological|SA4Ag vaccine low dose|Subjects receive 1 intramuscular injection (0.5 mL) of the low dose level of the SA4Ag vaccine.
16167514|NCT01643941|Procedure|Blood draw|Blood for HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.
16167515|NCT01643941|Procedure|Colonization swab sample|Colonization swabs will be collected from all subjects at various timepoints.
16167516|NCT01643941|Biological|SA4Ag vaccine mid dose|Subjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA4Ag vaccine.
16167517|NCT01643941|Procedure|Blood draw|Blood for HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.
16167518|NCT01643941|Procedure|Colonization swab sample|Colonization swabs will be collected from all subjects at various timepoints.
16167519|NCT01643941|Biological|SA4Ag vaccine high dose|Subjects receive 1 intramuscular injection (0.5 mL) of the high dose level of the SA4Ag vaccine.
16167520|NCT01643941|Procedure|Blood draw|Blood for HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.
16167521|NCT01643941|Procedure|Colonization swab sample|Colonization swabs will be collected from all subjects at various timepoints.
16167522|NCT01643941|Biological|SA3Ag vaccine|Phase 2 only: Subjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA3Ag vaccine.
16167523|NCT01643941|Procedure|Blood sample|Blood for immunogenicity will be collected from all subjects at various timepoints.
16167524|NCT01643941|Procedure|Colonization swab sample|Colonization swabs will be collected from all subjects at various timepoints.
16167525|NCT01643941|Biological|Placebo|Subjects receive one intramuscular injection (0.5 mL) of placebo which contains excipients of the vaccine formulation minus the active ingredients.
16167526|NCT01643941|Procedure|Blood draw|Blood for HIV, HBV and HCV screening will be collected prior to enrollment for Phase 1 subjects. Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.
16167527|NCT01643941|Procedure|Colonization swab samples|Colonization swabs will be collected from all subjects at various timepoints.
16167528|NCT01643928|Biological|Rituximab-Pfizer (PF-05280586) x 3 courses|1000 mg intravenous infusion [IV] on Days 1 and 15 of each 24 week treatment course for up to 3 treatment courses
16167632|NCT01643135|Drug|tranexamic acid|Transamine acts as antifibrinolysis which looks alike 0.9% NaCl (placebo)
16322362|NCT00482222|Drug|fluorouracil|
16167529|NCT01643928|Biological|Rituximab-EU+ Rituximab-Pfizer x 2 Courses|Subjects will receive Rituximab-EU x 1 course followed by Rituximab-Pfizer x 2 courses. 1000 mg IV infusion of Rituximab-EU on Days 1 and 15 of a 24 week treatment course followed by 1000 mg IV infusion of PF-05280586 on Days 1 and 15 of each 24 week course for up to 2 additional treatment courses
16167530|NCT01643928|Biological|Rituximab-US + Rituximab-Pfizer x 2 Courses|Subjects will receive Rituximab-US x 1 course followed by Rituximab-Pfizer x 2 courses. 1000 mg IV infusion of Rituximab-US on Days 1 and 15 of a 24 week treatment course followed by 1000 mg IV infusion of PF-05280586 on Days 1 and 15 of each 24 week course for up to 2 additional treatment courses
16167531|NCT01643915|Behavioral|No distraction method|Patients with conventional treatment. No distraction method during the treatment visits.
16167532|NCT01643915|Behavioral|Distraction method|Patients will see a cartoon film in a screen attached to the ceiling, just above the dental chair during the second treatment visit.
16167533|NCT01643915|Behavioral|Distraction method|Patients will see a cartoon film with with Rimax® multimedia eyeglasses that occlude the environment partially during the second treatment visit.
16167534|NCT01643902|Drug|tPA|IV tPA 0.9 mg/kg maximum of 90 mg. Administered by standard protocol. 10% of the dose by intravenous bolus injection, followed by infusion of the remainder over an hour. Treatment will be initiated within 4.5 hours of awakening with preferred target door to needle time of 60 minutes or less from ED arrival.
16167535|NCT01643889|Drug|Treatment A (domperidone 10 mg)|1 domperidone 10 mg capsule four times a day (q.i.d.) + 1 domperidone placebo capsule q.i.d. on Days 1 to 3 and a single dose on Day 4 (13 doses in total), and 1 moxifloxacin placebo capsule in the morning of Day 1.
16167536|NCT01643889|Drug|Treatment B (domperidone 20 mg)|2 domperidone 10 mg capsules four times a day (q.i.d.) on Days 1 to 3 and a single dose on Day 4 (13 doses in total), and 1 moxifloxacin placebo capsule in the morning of Day 1.
16167537|NCT01643889|Drug|Treatment C (placebo)|2 domperidone placebo capsules four times a day (q.i.d.) on Days 1 to 3 and a single dose on Day 4 (13 doses in total), and 1 moxifloxacin placebo capsule in the morning of Day 1.
16167538|NCT01643889|Drug|Treatment D (moxifloxacin)|2 domperidone placebo capsules four times a day (q.i.d.) on Days 1 to 3 and a single dose on Day 4 (13 doses in total), and 1 moxifloxacin 400 mg capsule in the morning of Day 1.
16167539|NCT01643876|Behavioral|Palatal brushing|Participants will be instructed to brush their palate with a manual soft-bristle brush after each meal and before sleeping for a period of 3 months. They will be asked to keep to their usual oral and denture hygiene routine during the trial to allow the isolation of the effect of palatal brushing.
16167540|NCT01643850|Drug|MCS110|Patients will receive up to 6 doses of MCS110 (3 or 5 or 10mg/kg) administered intravenously once every 4 weeks. Before each dosing, safety will be assessed.
16167541|NCT01643850|Drug|Placebo|Participants will receive a single dose of NaCl on day 1 through intravenous infusion.
16167542|NCT01643837|Other|Osteopathic Manipulative Treatment|OMT - Sacral Ligamenotus Articular Release; OMT - Lumbar Spine (L1-L2) and Lower Thoracic Spine (T10-12) Ligamentous Articular Release; OMT - Upper Thoracic Spine Ligamentous Articular Release (T1-T8); OMT - Cervical Spine Ligamentous Articular Release (C5-C7); OMT - Suboccipital Myofascial Release; OMT - Clavicular Ligamentous Articular Release; OMT - First Rib Ligamentous Articular Release; OMT - Ribs 2-8 Ligamentous Articular Release; OMT - Pectoral Pull; OMT - Sternal Ligamentous Articular Release; OMT - Direct Myofascial Release of the Diaphragm; OMT - Thoracic Lymphatic Pump; OMT - Fascial Release of Breast Tissue
16167543|NCT01643837|Other|Osteopathic Manipulative Light Touch Protocol (LT)|LT - Sacral Region; LT - Lumbar Spine and Lower Thoracic Region; LT - Upper Thoracic Spine Region; LT - Cervical Spine Region; LT - Suboccipital Region; LT - Clavicles; LT - First Ribs; LT - Ribs 2-8; LT - Pectoralis Muscles; LT - Sternum; LT - Respiratory Diaphragm; LT - Upper Thoracic Cage; LT - Lower Thoracic Cage
16167544|NCT01643824|Radiation|Proton Beam Therapy|"- Prescription dose to PTV as according to the following dose escalation schema: Arml 1: 60 GyE /10 fx, 6GyE fraction dose, 5 days/week, for HCC free from the alimentary tract (i.e., stomach, duodenum, esophagus, small and large bowel) (more than 2cm from clinical target volume), TLV30 <40%, and/or RLV30 <30%) Arm 2: 50 GyE /10 fx, 5GyE fraction dose, 5 days/week, for HCC close to the alimentary tract (less than 2cm from clinical target volume) but not contact with the alimentary tract, TLV30<50% and RLV30<40% Arm 3: 35 GyE /10 fx, 4GyE fraction dose, 5 days/week, for HCC contact to the alimentary tract (contact with clinical target volume), TLV30<60%, and/or RLV30<50%
~- Dose prescription : 95% isodose volume of prescribed dose encompassed PTV"
16167545|NCT01643811|Procedure|gastrectomy|subtotal gastrectomy with gastroduodenostomy or loop gastrojejunostomy or Roux Y gastrojejunostomy total gastrectomy with Roux Y esophagojejunostomy
16167546|NCT01643811|Procedure|Endoscopic submucosal dissection|endoscopic submucosal dissection
16167547|NCT01643798|Procedure|Sham rTMS|The eSham system was implemented in conjunction with a specialized Neuronetics sham TMS coil. This coil has a metal plate hidden inside of it that blocks the magnetic field from affecting the brain. Scalp electrodes were used to mimic the feel of real rTMS. This approach has been validated in previous studies.
16167548|NCT01643798|Procedure|Real rTMS|An iron-core, solid-state figure-of-8 coil was used to stimulate the dorsolateral prefrontal cortex. The site of stimulation was estimated using the Beam F3 method based on the 10-20 EEG system.
16167549|NCT01643785|Drug|Second-line quadruple therapy with endonase|Compare Second-line quadruple therapy w/o pronase (endonase)
16167550|NCT01643772|Drug|Oxycodone hydrochloride|The subjects will be randomized to receive either a single dose of OxyNorm® Capsules 5, 10, 20mg, or multiple-dose OxyNorm® Capsules 10 mg for 13 times.
16167551|NCT01643759|Drug|buprenorphine|The subjects will be randomized to receive either a single dose of BTDS 5, or BTDS 10, or BTDS 20 for 7 days. Plasma concentrations of buprenorphine and norbuprenorphine will be analyzed to determine the following pharmacokinetic parameters: AUC0-t:pg•hr/ml-Area under the plasma concentration-time curve frame: predose,6,12,24,36,48,60,72,96,120,144,168,169,170,171,172,174,180,192,216,240 hours post-dose.AUC0-inf:pg•hr/ml-Area under the plasma concentration-time curve extrapolated to infinity. Cmax: pg/ml-Maximum observed plasma buprenorphine concentration. Tmax: hrs-time at which Cmax is first observed. t½: Apparent half life of buprenorphine elimination.
16167552|NCT01643746|Device|Supera Stent|Angioplasty and stenting will performed according to the guidelines of the Society of Interventional Radiology and the instruction for use for each stent. Patients will be allocated to Supera stent versus LifeStent based on block randomization (block size 4 patients).
16322363|NCT00482222|Drug|leucovorin calcium|
16167553|NCT01643746|Device|Life Stent|Angioplasty and stenting will performed according to the guidelines of the Society of Interventional Radiology and the instruction for use for each stent. Patients will be allocated to Supera stent versus LifeStent based on block randomization (block size 4 patients).
16167554|NCT01643733|Device|Using Flow measurements to guide fistula angioplasty (Transonics)|Transonics flow measurements in the fistula would be used to guide the fistula intervention
16167555|NCT01643707|Behavioral|Evidence based guidelines and tools|Education, guidelines, tools
16167556|NCT01643694|Behavioral|Electronic intervention suggesting behavioral activity|3.6 Those randomized to the intervention will be asked to choose 1 self-directed activity from an electronically provided list sent to them weekly for 10 consecutive weeks. Each activity will take less than 5 minutes to complete. They will also answer 3-5 questions weekly (items taken from the survey items list submitted).
16167557|NCT01643681|Procedure|Autologous Adipose Tissue derived MSCs Transplantation|Into lumbar intervertebral disc infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 4x10e7 cells/1mL
16167558|NCT01643668|Drug|Busulfan|Busulfan as part of reduced intensity conditioning prior to allogeneic stem cell transplantation
16167559|NCT01643668|Drug|Clofarabine|Clofarabine as part of reduced intensity conditioning prior to allogeneic stem cell transplantation
16167560|NCT01643668|Procedure|Allogeneic Stem Cell Infusion|Allogeneic stem cell transplantation after reduced intensity conditioning with busulfan / clofarabine chemotherapy
16167561|NCT01643655|Procedure|Autologous Adipose Tissue derived MSCs Transplantation|Into the Femoral Head infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e8 cells/3mL
16167562|NCT01643642|Other|Cognitive behavioral treatment/farmacotherapy intervention|Brief cognitive behavioral intervention/farmacotherapy; intake, treatment and ROM
16167563|NCT01643642|Other|Treatment As Usual|Other: Treatment As Usual
16167564|NCT01643629|Biological|Autologous Human Platelet Lysate (HPL)|Study arm A will include subjects receiving three doses of Autologous Human Platelet Lysate at an interval of one month each.
16167565|NCT01643629|Other|2 % Minoxidil and /or Finasteride|Control arm B subjects will receive Standard therapy (2% Minoxidil and/or Finasteride)
16167566|NCT01643616|Drug|midazolam|Prior to performing the regional anesthesia the investigators administered midazolam as a premedication by mouth (3,75-7,5mg) or intravenously (2-3mg).
16167567|NCT01643616|Drug|Prilocaine 1%|20ml Prilocaine 1% for distal sciatic nerve block (30ml Prilocaine 1% in outpatients)
16167568|NCT01643616|Drug|Ropivacaine 0.75%|10ml Ropivacaine 0.75% for distal sciatic nerve block (not in outpatients)
16167569|NCT01643616|Drug|Prilocaine 1%|10ml Prilocaine 1% for saphenous nerve block
16167570|NCT01643616|Device|ultrasound guidance|In group US the sciatic nerve localization and needle guidance is realized using ultrasound.
16167571|NCT01643616|Device|nerve stimulation technique|In the group NS sciatic nerve localization and needle guidance is realized using nerve stimulation technique. However, ultrasound is used observing (Observer) the procedure, but blinded for the physician (Anesthetist) performing the block.
16167572|NCT01643603|Drug|Dasatinib|Patients receive dasatinib PO every day (QD) for 6 months.
16167573|NCT01643603|Other|laboratory biomarker analysis|Correlative studies
16167574|NCT01643590|Biological|JVS-100 15 mg dose Injection|Intramyocardial Injection
16167575|NCT01643590|Biological|Placebo Injection|Intramyocardial Injection
16167576|NCT01643590|Biological|JVS-100 30 mg dose injection|Intramyocardial Injection
16167577|NCT01643577|Procedure|Acupuncture for gastroparesis|A series of acupuncture points selected for the treatment of gastroparesis will be used at each of the 10 acupuncture sessions
16167578|NCT01643577|Procedure|Acupuncture for musculoskeletal pain|Acupuncture points selected for the treatment of musculoskeletal pain will be used during each of the 10 acupuncture sessions
16167579|NCT01643538|Behavioral|Financial incentive|Participants will receive a direct financial incentive in the amount of $20 for each week when their daily pedometer step count equals or exceeds their goal at least 5 out of 7 days.
16167580|NCT01643538|Behavioral|Social Goal|Participants will be asked to identify a charity to which they would like to donate the payment for reaching their walking goal. Each week they will be asked to designate which charity should receive a donation if they meet or exceed their goal. If they meet the goal, they will be notified that a donation of $20 in their name has been sent to the charity.
16167581|NCT01643538|Behavioral|Personal financial incentives & social goals|Participants will be able to allocate their reward for reaching their walking goal: the $20 reward can be divided between personal financial incentive and a charitable donation. Each week, the participant will be asked to choose whether to keep, give, or split the reward, if they meet or exceed their goal. If they choose to send some of the money to charity, they will be asked to identify a charity to which they would like to donate the payment. If they meet their goal, they will be notified by email or mail (based on their preference), that a donation of the selected amount has been sent to the charity.
16167582|NCT01643538|Behavioral|daily pedometer use and weekly feedback|Daily use of pedometer for 5 months. Walking goal set based on level of walking during 2-week run-in period. Weekly feedback provided on meeting walking goal - defined as achieving goal number of steps for 5 of 7 days per week.
16167583|NCT01643525|Device|Nautilus NeuroWaveTM System|Non-invasive device designed to detect pressure signals from the skull to aid in the diagnosis of ischemic stroke.
16167584|NCT01643499|Drug|oxaliplatin|Given IV
16167585|NCT01643499|Drug|irinotecan hydrochloride|Given IV
16167586|NCT01643499|Drug|leucovorin calcium|Given IV
16167587|NCT01643499|Drug|fluorouracil|Given IV
16167588|NCT01643499|Other|laboratory biomarker analysis|Correlative studies
16167589|NCT01643486|Other|iTouch phosphate counting program|After developing and pilot testing the iTouch phosphate counting program, the participants in the intervention arm will enter their meal into the program; the required number of phosphate binders will be calculated for the patient
16167590|NCT01643486|Other|Usual Care|The patients randomized to the usual care arm will continue to receive the usual dietary counselling and will input meal data into the iTouch program but no recommendations for the number of phosphate binders to be taken with the meal will be provided
16167633|NCT01643135|Drug|0.9% NaCl|0.9% NaCL (NSS) is clear fluid which looks alike tranexamic acid
16167903|NCT01641224|Drug|Placebo|Placebo is blindly given to patients.
16167591|NCT01643473|Behavioral|Adherence Intervention|Patients randomized to the TAI group will complete a tailoring survey at the baseline visit to identify the most salient adherence barriers to the individual, which will be used to create an individualized adherence profile. Following completion of the tailoring survey, patients will collaborate with the RA to identify the most suitable mix of intervention strategies for improving medication adherence (i.e., reminder aids, motivational interviewing, case management) that are matched to the barriers outlined on patients' individualized adherence profiles.
16167592|NCT01643473|Other|Attention Control|Health education videos on topics unrelated to medication adherence, hypertension or type 2 diabetes
16167593|NCT01643460|Procedure|98% Ethanol & Paclitaxel injection|Pancreatic cyst injection via Endoscopic Ultrasound (EUS)of 98% Ethanol with Paclitaxel (dose determined in relation to cyst size & amount of fluid aspirated from the cyst.
16167594|NCT01643447|Drug|Ulinastatin|Ulinastatin Preventing Postoperative Hepatic Failure in Hepatocellular carcinoma (HCC)
16167595|NCT01643447|Drug|Diammonium glycyrrhizinate|
16167596|NCT01643434|Drug|Spironolactone|Spironolactone (titrating dose from 12.5 to 50mg SID)
16167597|NCT01643434|Drug|Clonidine|Clonidine (titrating dose from 0.100-0.300mg BID)
16167598|NCT01643421|Other|Deep inspiration and positive expiratory airway pressure|It was used a device the combines deep inspiration and positive expiratory airway pressure in asthmatic subjects, for 5 weeks, twice a day.
16167599|NCT01643408|Drug|asparaginase Erwinia chrysanthemi|
16167600|NCT01643395|Other|vertebroplasty|Vertebroplasty consists in the injection of cement (PMMA) in the damaged vertebral body to prevent further collapse
16167601|NCT01643395|Other|conservative therapy|The study is a prospective, randomized trial comparing conservative treatment (brace) and vertebroplasty in acute (less than 15 days after trauma) traumatic vertebral compression fracture (VCF) type A according Magerl classification.
16167602|NCT01643382|Drug|Insulin|Insulin will be given in a continuous low dose infusion. The infusion will be adjusted based on the patient's blood sugar with the goal of keeping the level between 100-140 mg/dL
16167603|NCT01643382|Drug|Insulin, Asp(B28)-|Insulin will be given through subcutaneous injection every few hours based on the patient's blood sugar level.
16167604|NCT01643369|Behavioral|Cognitive-Based Compassion Training|Eight-week training in compassion meditation, using a protocol developed by Geshe Lobsang Negi, Ph.D. of Emory University
16167605|NCT01643369|Behavioral|Adult Health Education Curriculum|Eight week training in health and wellness, using a curriculum developed specifically for this study.
16167606|NCT01643369|Behavioral|Mindful Attention Training|Eight week training in mindful attention, using a protocol developed by B. Alan Wallace, Ph.D.
16167607|NCT01643356|Behavioral|Intervention to reduce excess weight gain during pregnancy|Intervention includes meetings with a nutrition counselor and/or psychologist where individualized eating plans will be developed and reviewed, and regular group meetings during which information about healthy eating for weight management will be discussed.
16167608|NCT01643330|Genetic|AAV1/SERCA2a (MYDICAR)|Single intracoronary infusion 1 x 10^13 DNase Resistant Particles (DRP) MYDICAR
16167609|NCT01643330|Genetic|Placebo|Single intracoronary infusion
16167610|NCT01643304|Behavioral|No drug|No drug intervention. The intervention is a questionnaire with quality of life and perception of menstrual bleedings. All subjects will complete both questionnaires.
16167611|NCT01643291|Procedure|Ultrasound|Ultrasound guidance for difficult lumbar punctures in the leukemic pediatric population.
16167612|NCT01643278|Drug|Dasatinib|Given PO
16167613|NCT01643278|Biological|Ipilimumab|Given IV
16167614|NCT01643278|Other|Laboratory Biomarker Analysis|Correlative studies
16167615|NCT01643278|Other|Pharmacological Study|Correlative studies
16167616|NCT01643265|Dietary Supplement|Whey Milk Protein|20 grams of Whey Milk Protein
16167617|NCT01643265|Dietary Supplement|Bovine Albumin Concentrate|20 grams of Bovine Albumin Concentrate
16167618|NCT01643252|Drug|riboflavin: 0.12% riboflavin ophthalmic solution with the KXL system|Subjects will receive 0.12% riboflavin ophthalmic solution (VibeX) followed by irradiation with the KXL system at 30mW/cm^2 for 4 minutes
16167619|NCT01643252|Drug|placebo: 0.0% riboflavin ophthalmic solution with the KXL system|Subjects will receive 0.0% riboflavin ophthalmic solution (placebo) followed by irradiation with the KXL system at 30mW/cm^2 for 4 minutes
16167620|NCT01643239|Other|Hospital-based mCIT restraint of the unaffected arm and practice of the affected arm|the mCIT group with individualized intervention
16167621|NCT01643239|Other|Hospital-based mCIT|the mCIT group with individualized intervention
16167622|NCT01643239|Other|Hospital-based TR|OT or PT or therapist-based training
16167623|NCT01643226|Drug|riboflavin solution|0.12% riboflavin ophthalmic solution
16167624|NCT01643226|Drug|placebo solution|0.0% riboflavin ophthalmic solution
16167625|NCT01643226|Device|KXL System|30 mW/cm2
16167626|NCT01643213|Device|Non Boston Scientific SCS Trial Therapy|No procedures will be attempted as part of this study. This intervention refers to connection and activation of a previously implanted and programmed FDA-approved non Boston Scientific SCS trial system for 30 minutes of SCS therapy for pain
16167627|NCT01643213|Device|BSC approved SCS Trial Therapy w/ OMG|No procedures will be attempted as part of this study. This intervention refers to connection and activation of all Boston Scientific commercially approved SCS trial systems for 30 minutes of SCS therapy for pain
16167628|NCT01643187|Dietary Supplement|Beverage fortified with 21 vitamins and minerals|The serving contains 4 grs. of protein, 12 grs. of carbohydrate, 1 gr of fat 9 mg of zinc, 12.5 mg iron, 160 µg of folic acid, 90 µg of iodine, 250 mg of vitamin A, 40 mg of vitamin C, 0.5 mg of vitamin B6, 0.9 µg of vitamin B12, 6 mg of niacin, 0.5 mg of vitamin B2, 0.5 mg of vitamin B1, 0.3 mg of copper, 5 mg of vitamin D3, 5 mg of vitamin E, 200 mg ofcalcium, 150 mg of phosphorous, 40 mg of magnesium, 17 µg of selenium, 0.17 µg of manganese, 1.8 mg of pantothenic acid and 8 µg of biotin.
16167629|NCT01643187|Dietary Supplement|Lactose-free milk|Serving contains 4 grs. of protein, 12 grs of carbohydrate and 1 gr of fat
16167630|NCT01643161|Behavioral|Treatment As Usual|Communicating the diagnosis to the patient's primary care doctor and neurologist. May include referrals for physical therapy or psychiatric evaluations, or referrals to community therapists or doctors.
16167631|NCT01643161|Behavioral|Guided Self-Help|A self-help workbook based on cognitive behavioral therapy, and four half-hour guidance sessions over a three-month period.
16167634|NCT01643122|Other|No drug|Patients with expected stable endometriosis management status (EMS), i.e. patients who have not planned a change in endometriosis treatment or a therapeutic surgical procedure in the next 12 weeks and have had no change in endometriosis treatment or therapeutic surgical procedure in the previous 4 weeks.lease specify as free-text; for drugs include daily dose, dosage form dosage frequency and duration (if appl. and possible for the OS/NIS).
16167635|NCT01643122|Other|No drug|Patients with expected change in endometriosis management status (EMS), i.e. patients who have planned a change in endometriosis treatment or a therapeutic surgical procedure during the next 12 weeks or have undergone a change in endometriosis treatment or a therapeutic surgical procedure in the previous 4 weeks.
16167636|NCT01643109|Other|Casting & CIMT|"A standardized CIMT protocol will be administered over a three week period. The first week will consist of wearing a below elbow cast on the non-hemiplegic limb followed by a two week CIMT camp (5 hours per day, 5 days per week) where the child/youth wears a constraint splint on the non-hemiplegic hand. The two week camp will follow a standardized CIMT camp protocol (Hand2Hand developed at HBKRH) that includes activities that focus on unilateral hemiplegic hand activity in the first week and increasing incorporation of bilateral hand activities in the second week. The camp protocol for CIMT is based on camp protocols utilized successfully in other paediatric research studies."
16167637|NCT01643096|Other|Zataria multiflora Boiss|Thermic effect of food of Zataria multiflora Boiss and comparison between hot and cold temperament people
16167638|NCT01643096|Other|Sumac|Thermic effect of food of Sumac and comparison between hot and cold temperament people
16167639|NCT01643083|Drug|Rifaximin|Rifaximin 400mg tid for 2 wk
16167640|NCT01643083|Drug|Placebo|Placebo for 2 week
16167641|NCT01643070|Drug|Capecitabine, Oxaliplatin|Induction chemotherapy - Capecitabine (1250 mg/m2 PO twice daily on D1-14 and oxaliplatin 130 mg/m2 on D1, every 3 weeks for 2 cycles) Preoperative chemoradiotherapy - Capecitabine 825 mg/m2 PO twice daily during radiotherapy and oxaliplatin 50 mg/m2/day on weekly.
16167642|NCT01643070|Radiation|Radiotherapy|Preoperative radiotherapy, 5040 cGy with 28 fractions
16167643|NCT01643057|Device|Stochastic Resonance Mattress|The infant's isolette mattress will be replaced with a specially designed mattress (non-commercially available, designed by engineers at the Wyss Institute, Harvard University) to provide gentle vibrations and sounds during mattress stimulations.
16167644|NCT01643044|Behavioral|Nutrition time control/placebo intervention|This time-control intervention, designed in part to help promote research assistant blinding as to participant condition, focused on proper infant nutrition using a computer-delivered, interactive format and videos.
16167645|NCT01643044|Behavioral|Computer-delivered, brief intervention on alcohol use|A single 20-minute interactive computer-delivered intervention designed to promote motivation to change prenatal alcohol use, without presuming the participant to be currently using alcohol while pregnant.
16167646|NCT01643031|Drug|Ticagrelor|Ticagrelor will be given (to patients with low response to clopidogrel randomized to the Ticagrelor group) at a dose of 180 mg given 1-2 hours before the coronary angiography, followed by 90 mg twice a day for 30 days after the PCI. After 30 days the patient's treatment will be switched back to clopidogrel (to complete 1 year of treatment).
16167647|NCT01643031|Drug|Continued clopidogrel|Patients with low response to clopidogrel randomized to continued clopidogrel treatment will be given an additional 300 mg of clopidogrel loading 1-2 hours before coronary angiography (in addition to the previous 300 mg load or chronic clopidogrel therapy the patient received), followed by 75 mg a day for 1 year after the PCI
16167648|NCT01643018|Procedure|laparoscopic surgery|In laparoscopy group three trocars is used. The first is 10 mm and inserted within the umbilicus for telescop, the second is 10 mm and inserted just below the xiphoid process, and third is 5 mm and inserted at the right upper quadrant of the abdomen.
16167649|NCT01643018|Procedure|open surgery|-open surgery group describes the patients treated with traditional open surgery. In open surgery group a right subcostal incision is used.
16167650|NCT01643005|Behavioral|Relationship Strengthening HIV Prevention Intervention|The relationship strengthening HIV intervention will build on the structure of the Nurturing Parenting Groups and will be integrated so that participants will receive the Nurturing Parenting Groups plus the relationship strengthening HIV intervention.
16167651|NCT01643005|Behavioral|Parenting Program Intervention|Nurturing Parenting curriculum delivered in a group format.
16167652|NCT01642979|Drug|Levamisole+cyclosporin A+Glucocorticoids|Levamisole 2.5mg/kg every other day cyclosporin A 1.5-2.5mg/kg every other day Glucocorticoids0.5-1mg/kg every day(prednisone)
16167653|NCT01642979|Drug|cyclosporin A+Glucocorticoids|cyclosporin A 1.5-2.5mg/kg every day Glucocorticoids0.5-1mg/kg every day(prednisone)
16167654|NCT01642979|Drug|Glucocorticoids|Glucocorticoids 0.5-1mg/kg every day(prednisone)
16167655|NCT01642966|Drug|Prasugrel|Prasugrel 10mg/day for 15 days
16167656|NCT01642966|Drug|Ticagrelor|Ticagrelor 90mg twice a day for 15 days
16167657|NCT01642953|Dietary Supplement|Early recovery|The patients are started on sips of water on the first postoperative day. If they are tolerable, a liquid diet is started on the second postoperative day, and a soft diet on a third postoperative day for them. We have a plan to discharge the patients on the fourth postoperative day if they exhibit at least three times soft diet without specific complaint and had normal clinical status and physical examination.
16167658|NCT01642940|Drug|Prasugrel|Prasugrel 10mg/day
16167659|NCT01642940|Drug|Ticagrelor|Ticagrelor 90mg twice a day
16167660|NCT01642914|Drug|Linaclotide 290 micrograms|oral capsule, taken once daily each morning at least 30 minutes before breakfast
16167661|NCT01642914|Drug|Linaclotide 145 micrograms|oral capsule, taken once daily each morning at least 30 minutes before breakfast
16167662|NCT01642914|Drug|Matching placebo|oral capsule, taken once daily each morning at least 30 minutes before breakfast
16167663|NCT01642901|Drug|Zoledronic acid|5 mg zoledronic acid infused intravenously over two hours (2.5mg per hour), given only once, within 21 days of acute traumatic spinal cord injury.
16167664|NCT01642901|Drug|normal saline 0.9%|Infusion of equivalent volume of 0.9% normal saline to that of the reconstituted zoledronic acid, given only once over two hours, occurring within 21 days of acute traumatic spinal cord injury
16167665|NCT01642888|Biological|C-Tb|The C-Tb agent is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme
16168081|NCT01639833|Device|Veriset Hemostatic Patch|Topical hemostat
16167666|NCT01642888|Biological|2 T.U. Tuberculin PPD RT 23 SSI|The 2 T.U. Tuberculin PPD RT 23 SSI agent is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme
16167667|NCT01642875|Other|Enteral nutrition|Standard enteral diet is administered through a nasojejunal tube. Enteral nutrition is started on the 1st postoperative day and increased daily by 20-40 ml up to the estimated level.
16167668|NCT01642875|Other|Oral nutrition|Oral diet is started from the 2nd postoperative day and oral intake is advanced as tolerated
16167669|NCT01642862|Drug|Simvastatin|Comparison of pharmacokinetic parameters of different formulations (liquid vs tablet) and doses (20 or 40 mg) of simvastatin after single oral administration of the drug
16167670|NCT01642849|Dietary Supplement|high protein diet|6 months on HP diet
16167671|NCT01642849|Dietary Supplement|high carbohydrate diet|12 subjects will be placed on a hig carbohydrate diet for 6 months
16167672|NCT01642836|Behavioral|MMM|"a theory-based community team sports program designed specifically for overweight and obese children,
~a home-based family intervention to reduce screen time, alter the home food/eating environment, and promote self-regulatory skills for eating and activity behavior change, and
~a primary care provider behavioral counseling intervention linked to the community and home interventions."
16167673|NCT01642836|Behavioral|Health and Nutrition Education|"Enhanced standard care/health and nutrition education intervention:
~notification of primary care providers about metabolic measures and blood pressure
~state-of-the-art information-based health and nutrition education, including semi-annual home counseling visits, monthly health education newsletters for children and for parents/guardians, and a series of quarterly, community-based evening health lectures and Family Fun Nights"
16167674|NCT01642810|Behavioral|Acceptance-based behavioural therapy|Behavioral intervention focusing on acceptance, mindfulness and values-based living instead of focus on symptom control
16167675|NCT01642810|Other|Will vary per participant|Participants will continue pre-study treatment under their current licensed practitioners. Intervention may include drug treatment, physical therapy, or other
16167676|NCT01642797|Device|Confocal laser endomicroscopy (Pentax, EG3870K)|Confocal laser endomicroscopy with Targeted Biopsy
16167677|NCT01642797|Device|Standard White-light endoscopy (Pentax, 90i)|Standard White-light endoscopy with Standard Biopsy
16167678|NCT01642784|Device|Primary PCI of culprit lesion in IRA with drug eluting stent (DES)|Primary PCI of culprit lesion in IRA with drug eluting stent (DES)
16167679|NCT01642784|Device|Primary PCI of culprit lesion in IRA with drug eluting stent (DES) and PCI of the other critical lesion in IRA with another DES|Primary PCI of culprit lesion in IRA with drug eluting stent (DES) and PCI of the other critical lesion in IRA with another DES
16167680|NCT01642771|Drug|5-Fu/epirubicin/CTX following Docetaxel|Cycle 1-3: Docetaxel i.v. 75mg/m2 (One cycle = 21 days); Cycle 4-6: Fluorouracil i.v. 500 mg/m2, Epirubicin i.v. 75 mg/m2, Cyclophosphamide i.v. 500 mg/m2 (One cycle = 21 days)
16167681|NCT01642771|Drug|Docetaxel/capecitabine followed by XEC|Cycle 1-3: Docetaxel i.v. 75 mg/m2, Capecitabine, p.o., 1000 mg/m2，b.i.d (take Capecitabine for 2 weeks and withdraw for 1 week) (One cycle = 21 days); Cycle 4-6: Capecitabine, i.v. 1000 mg/m2, b.i.d (take for 2 weeks and withdraw for 1 week),Epirubicin, i.v. 75 mg/m2, Cyclophosphamide, i.v. 500 mg/m2 (One cycle = 21 days)
16167682|NCT01642758|Drug|Sodium 2,2 dimethylbutyrate|Oral capsules, dose 20 mg/kg/day, once per day for 26 weeks
16167683|NCT01642745|Drug|Methacholine (Provocholine)|two minutes of aerosol inhalation of concentrations of methacholine ranging from 0.03 - 256mg/mL
16167684|NCT01642745|Drug|Mannitol (Aridol)|single deep inhalation of dry powder per dose doses range from 0mg - 160mg (cumulative dose range 0mg-635mg).
16167685|NCT01642745|Drug|Methacholine (Provocholine)|two minutes of aerosol inhalation of concentrations of methacholine ranging from 0.03 - 256mg/mL every 20 seconds a deep inhalation is performed
16167686|NCT01642732|Other|Everolimus, lupron, bicalutamide, and radiation|"Everolimus - there are five dose levels (2.5mg. every 48 hrs.,2.5mg./day, 5mg./day, 7.5mg./day, and 10mg./day) based on the initial expectations of toxicity and the incidence of toxicity of subjects already treated. Subjects will be on one dose level throughout the study. Subjects will receive everolimus starting on study day 1.
~Radiation therapy will start on day 60-70 (44 treatments, at 5 treatments a week for a little longer than 8 weeks).
~Bicalutamide (50 mg. tablets daily) will begin on study day 10-14, approximately 2 months prior to Radiation Therapy.
~Lupron injections will begin on study day 15 to 25, approximately 2 months prior to Radiation Therapy. The typical dose schedule is either one injection (22.5 mg. dose)every 3 months for a total of 8 injections or one injection (30 mg. dose) every 4 months for a total of 6 injections.
~Radiation, bicalutamide, and everolimus will end between study day 120-130. Lupron will end at 24 months on study."
16167687|NCT01642719|Behavioral|Sleep restriction|Participants will be asked to reduce their time in bed (TIB) by 60 min below their median baseline TIB, and to maintain this sleep restriction every night for 12 weeks.
16167688|NCT01642719|Behavioral|Non-sleep restriction|Participants will be asked to maintain fixed bedtimes, wake-times, times in bed, and napping, consistent with each person's average baseline.
16167689|NCT01642693|Radiation|Low power laser in teeth after intrusive movement|Low power laser was aplied to premolar teeth under an intrusive movement to study histological changes and root resorption
16167690|NCT01642693|Other|Simulated laser in teeth with intrusive movements|Simulated laser in teeth with intrusive movements for histological and root resorption changes
16167691|NCT01642680|Other|A tailored physical activity program during chemotherapy|The early group will start the PA program during chemotherapy for 3 months, and after completion of chemotherapy for 3 months (total 6 months). The PA program will consist of two components: improvement of physical fitness and empowerment to adopt a healthy lifestyle. Longitudinal effects of this PA program will be evaluated at 5 time points: before chemotherapy; at start of the PA program and at 3, 6 and 18 months after start of the PA program. Safety parameters will be monitored throughout the study period.
16167692|NCT01642680|Other|A tailored physical activity program after chemotherapy|The late group will start the PA program after completion of the chemotherapy for 6 months. The PA program will consist of two components: improvement of physical fitness and empowerment to adopt a healthy lifestyle. Longitudinal effects of this PA program will be evaluated at 5 time points: before chemotherapy; at start of the PA program and at 3, 6 and 18 months after start of the PA program. Safety parameters will be monitored throughout the study period.
16322364|NCT00482222|Drug|oxaliplatin|
16167693|NCT01642667|Drug|Prourokinase|a bolus of 1.2 million IU and an infusion of 4.8 million IU in 60 min.
16167694|NCT01642667|Drug|Placebo|
16167695|NCT01642654|Other|Exercise|The WG was submitted to a 16-week WEP, with combined aerobic and resistance exercises in three weekly sessions. Water temperature was approximately 30º C with an average ambient temperature of 34° C. The pool had water levels ranging between 1,20 and 1,40 meters deep.
16167696|NCT01642654|Other|Educational lectures|Educational lectures
16167697|NCT01642641|Procedure|Non-surgical Subgingival Debridement (SD)|SD is a conservative non-surgical procedure aimed at reducing dental plaque and calculus from the tooth root usually under local anaesthesia.
16167698|NCT01642641|Procedure|Simplified Papilla Preservation Flap|The simplified papilla preservation flap is a novel conservative surgical procedure aimed at the preservation of the tissues between the teeth. It has been shown to significantly reduce pocket depth and has faster re-vascularisation of the flap, when compared with other procedures.
16167699|NCT01642641|Procedure|Resective Periodontal Flap with Osseous Recontouring (RPFO)|RPFO is a surgical procedure that involves the resection of soft and hard tissue to obtain optimum tissue architecture and pocket reduction or elimination.
16167700|NCT01642628|Other|Mirror Education|Patients allocated to the experimental group will be given a small hand-held mirror and structured mirror viewing education verbally. In addition, they will receive a mirror viewing handout. This intervention will be given prior to mastectomy surgery. In addition, participants will receive all other standard care.
16167701|NCT01642615|Drug|Dexlansoprazole|Dexlansoprazole capsules
16167702|NCT01642615|Drug|Dexlansoprazole|Dexlansoprazole capsules
16167703|NCT01642615|Drug|Placebo|Dexlansoprazole placebo-matching capsules
16167704|NCT01642602|Drug|Dexlansoprazole|Dexlansoprazole delayed-release capsules.
16167705|NCT01642589|Biological|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra®)|0.5 mL, Intramuscular
16167706|NCT01642589|Biological|Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed|0.5 mL, Intramuscular
16167707|NCT01642576|Behavioral|weight loss counselling|Diet counselling with or without sports trainers, over 8 months
16167708|NCT01642563|Procedure|Platelet transfusion|One dose of pathogen reduced platelets
16167709|NCT01642563|Procedure|Platelet transfusion|One dose of standard platelets
16167710|NCT01642550|Drug|RM-131|RM-131 (100 mcg) will be administered daily by subcutaneous injection for 28 days.
16167711|NCT01642550|Drug|Placebo|
16167712|NCT01642537|Device|Rhythmia Mapping System and the Rhythmia Mapping Catheter|Patients will undergo a diagnostic assessment with the Rhythmia Mapping System and the Rhythmia Mapping Catheter as part of the Electrophysiology Ablation Procedure.
16167713|NCT01642524|Biological|hypertonic saline mixed Dextran|single dose administered intravenously
16167714|NCT01642524|Biological|Saline solution|placebo - saline solution
16167715|NCT01642511|Radiation|99mTc-labeled Sulfur Colloid|Control Group: Each patient received the 1 intraparenchymal injection of 99mTc-SC (0.5~1.0 mCi/0.5mL) in the tumor quadrant. Study Group: Two syringes of 0.25~0.5 mCi 99mTc-SC in 0.2~1.0 mL volume were injected intraparenchymally into 2 quadrants of breast, at the 6 and 12 o'clock positions.
16167716|NCT01642511|Procedure|Axillary Sentinel Lymph Node Biopsy|Sentinel lymph node biopsy
16167717|NCT01642511|Drug|Methylthioninium|Four milliliters of methylthioninium was injected subcutaneously above the primary tumor or around the biopsy cavity 10 min before surgery
16167718|NCT01642511|Device|Lymphoscintigraphy|Sequential anterior and lateral gamma imaging was performed with patients lying prone and by injection side just before surgery using a digital gamma camera computer system (Toshiba GCA-901A/HG).
16167719|NCT01642511|Procedure|Axillary Lymph Node Dissection|ALND was performed consequently if axillary SLNB was failure or axillary SLNs were positive.
16167720|NCT01642511|Procedure|Internal Mammary Sentinel Lymph Node Biopsy|Internal mammary sentinel lymph node biopsy
16167721|NCT01642498|Device|ROX COUPLER|The COUPLER will be used to create an arteriovenous fistula in the iliac region (between the iliac artery and vein).
16167722|NCT01642485|Drug|Moxifloxacin 400 mg fasted|"Subjects receiving drug (400 mg moxifloxacin),having fasted overnight for 10 hours.
~This is the standard probe for the assessment of assay sensitivity in Thorough QT (TQT) studies."
16167723|NCT01642485|Other|FDA breakfast|Calorie reduced FDA standard breakfast (58% fat, low carbohydrates)- On the assumption that increases in C-peptide levels are responsible for the QTc shortening observed after a meal, a lesser effect on QTc compared to a carbohydrate rich breakfast should be observed.
16167724|NCT01642485|Other|Continental breakfast|High carbohydrate breakfast (>70% carbohydrates)- On the assumption that increases in C-peptide levels are responsible for the QTc shortening observed after a meal, a greater effect on QTc compared to a low carbohydrate breakfast (FDA standard breakfast) should be observed.
16167725|NCT01642485|Drug|Moxifloxacin 400 mg fed|Currently, there is no published data showing the effects of a single 400 mg oral dose of moxifloxacin on the ECG/QT/QTc after food.
16167726|NCT01642485|Procedure|Insulin Clamp|A euglycaemic/hyperinsulinaemic clamp, (DeFronzo, 1979) involves acutely raising the plasma insulin levels to a steady state and maintaining a state of euglycaemia with a glucose infusion, thereby effectively stopping endogenous insulin and C-peptide release. This technique will confirm whether hyperinsulinaemia has any effect on the QT/QTc interval.
16167727|NCT01642485|Drug|Placebo|Comparison of different meals effect on Moxifloxacin PK profile
16167728|NCT01642472|Drug|Ulipristal Acetate - open label|Ulipristal Acetate (PGL4001) tablets 10mg orally daily for 3 months (84 days) for each treatment course. There are four 3-month treatment courses in this study.
16167729|NCT01642459|Other|Same direction cannulation|The puncture direction of the arterial needle is same as the blood flow in every hemodialysis session.
16167730|NCT01642459|Other|Opposite direction cannulation|The puncture direction of the arterial needle is opposite to the blood flow in every hemodialysis session.
16167731|NCT01642446|Procedure|Precise hepatectomy|Precise hepatectomy
16167732|NCT01642446|Other|Combined intervention (chemoembolization/ablation)|transcatheter hepatic arterial chemoembolization and/or ablation
16167733|NCT01642433|Drug|Placebo|Placebo capsules, 3x daily
16167734|NCT01642433|Drug|Prazosin|Prazosin medication, 3x daily dosing, up to 15mg/day
16322844|NCT00478543|Drug|Furosemide|
16167735|NCT01642407|Drug|Sildenafil|Body weight > 20 kg: 20 mg TID (60 mg/day) Body weight ≤ 20 kg: 10 mg TID (30 mg/day) Treatment duration: 16 weeks in Part 1, until until sildenafil obtained marketing approval in Part 2
16167736|NCT01642394|Behavioral|Diabetes Self-Management Program|"The intervention will be performed by patients with type 2 diabetes and health professionals and it will be divided in 6 group sessions for two and a half hours each, on a weekly basis for 6 weeks. The session content includes techniques for dealing with problems in general, promotion of exercise, nutrition concepts, proper use of medication, effective communication and basic knowledge about diabetes and its complications. The sessions are supported with educational material.
~Two leaders, previously trained in the DSMP, will lead each group. The leading status (patient or health care professional) is obtained after attending a 6-week structured program of training, a successful completion of 4 days of training sessions, and taking part in a full course for patients with a proven leader."
16167737|NCT01642381|Behavioral|"Full Motivational Interviewing (FMI)"|Relational and technical technical (directive) strategies in counselling sessions to significantly increase commitment strength to reduce drinking.
16167738|NCT01642381|Behavioral|"Spirit Only Motivational Interviewing (SOMI)"|Empathic and non-directive counselling based on Rogerian psychotherapy model.
16167739|NCT01642368|Other|The Optimum Omega-3 Fatty Acid Feeding Study|Assess whether swapping specific food ingredients in the diet can significantly improve polyunsaturated fatty acid blood profiles and improve a person's response to cognitive measures and physical fitness.
16167740|NCT01642355|Behavioral|Prevention Consult|In addition to usual care, patients will receive a prevention consult by a prevention fellow and attending following their intervention. The consult will include guideline based medical recommendations for optimization of the patient's medical regimen targeting dyslipidemia, hypertension and diabetes. In addition, each patient will be educated on the cardiovascular disease process and given detailed lifestyle recommendations on physical activity, improved nutrition, smoking cessation and medication adherence.
16167741|NCT01642355|Behavioral|Consult & Behavioral Intervention|In addition to usual care and prevention consult (as detailed above), patients will receive a full motivational intervention program by a trained motivational coach and text messages over 6 months.
16167742|NCT01642342|Other|laboratory biomarker analysis|Correlative studies
16167743|NCT01642342|Other|pharmacological study|Correlative studies
16167744|NCT01642342|Biological|recombinant albumin fusion protein sEphB4-HSA|Given IV
16167745|NCT01642316|Other|washback|students received 8 specific related formative test for that lesson. plus a pre-test and post-test, Michigan English language proficiency test
16167746|NCT01642316|Other|routin intervention|students only received two tests, Michigan test of English language proficiency as pre-test and post-test.
16167747|NCT01642303|Other|vodcasting|listening to downloaded vodcasting files
16167748|NCT01642303|Other|no intervension|Listen to student book listening files
16167749|NCT01642277|Drug|Solifenacin|5 mg for 4 weeks with option to increase to 10 mg for an additional 8 weeks
16167750|NCT01642264|Behavioral|WeBREATHe Training Program|The WeBREATHe Training Program is a web-based, interactive training program to teach pediatric respiratory therapists, nurses and nurse practitioners how to help their patients' parents to quit smoking.
16167751|NCT01642251|Drug|Cisplatin|Given IV
16167752|NCT01642251|Drug|Etoposide|Given IV
16167753|NCT01642251|Drug|Veliparib|Given PO
16167754|NCT01642251|Drug|Placebo|placebo of Veliparib
16167755|NCT01642238|Drug|Ticagrelor + ASA + Bivalirudin|Single loading dose of Ticagrelor (180 mg given as two 90 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
16167756|NCT01642238|Drug|Clopidogrel + ASA + Bivalirudin|Single loading dose of Clopidogrel (600 mg given as two 300 mg tablets), plus single dose of ASA (one 81 mg tablet) + bivalirudin administered as 0.75 mg/kg IV bolus followed by 1.75 mg/kg/hour for 1 hour.
16167757|NCT01642212|Drug|Oral Budesonide Suspension (MB-9)|OBS suspension to be taken bid over a 16 week course of double blind therapy and OBS suspension to be taken qd to bid during a 24 week optional open label extension period
16167758|NCT01642212|Drug|Placebo|
16167759|NCT01642199|Behavioral|Reduced Intensity Behavioral Weight Loss + Peer Health Coach|Participants will receive a 12-month reduced intensity group behavioral weight loss program. During weeks that there are no group meetings, participants will be coached by peers (i.e., other members of their weight loss group).
16167760|NCT01642199|Behavioral|Reduced Intensity Behavioral Weight Loss + Mentor Health Coach|Participants will receive a 12-month reduced intensity group behavioral weight loss program. During weeks that there are no group meetings, participants will be coached by a mentor (i.e., successful weight loser).
16167761|NCT01642199|Behavioral|Reduced Intensity Behavioral Weight Loss|Participants will receive 12 months of a reduced intensity group behavioral weight loss program.
16167762|NCT01642186|Drug|everolimus|
16167763|NCT01642186|Drug|letrozole plus leuprolide|
16167764|NCT01642186|Drug|combination of everolimus, letrozole and leuprolide|
16167765|NCT01642173|Device|Optical Coherence Tomography (C7 XR Dragonfly )|Evaluation of the coronary artery using Optical Coherence Tomography utilizing the Dragonfly OCT catheter following a clinically indicated angiogram and endothelial function testing with a positive diagnosis of endothelial dysfunction. The procedure is repeated following 6 months of Lp-PLa2 inhibition or placebo.
16167766|NCT01642160|Behavioral|additional educational material|The internet-based intervention group would receive a weekly text or an email (based on the subject's preference). The content of the message asks about their approximate compliance over the past week. Based on their response, they will be directed to one of two internet web pages.
16167767|NCT01642160|Behavioral|Standard of care|participants will receive education from staff nurses as needed.
16167768|NCT01642147|Device|Transcranial Doppler (TCD)|A 2-MHz Transcranial Doppler probe (MULTI-DOP P2.2C; DWL, Elektronische Systeme GmbH, Germany) will be used to measure both sides of Vmca of both patients undergoing craniotomy and patients undergoing abdominal surgery. The signal will be range-gated to a depth of 45 to 60 mm at temporal bone window to achieve the optimal signal according to standard techniques. The measures will be recorded in the operation room before anesthesia, in the recovery room at extubation, 30, 60, 90, and 120 min after extubation.
16167804|NCT01641861|Procedure|Conventional method|caries removal by using rotary instrument.
16167769|NCT01642147|Procedure|jugular venous bulb catheterization|After local anesthesia, a jugular venous bulb catheter(16G, manufactured by Arrow International Inc. USA) will be placed in the dominant side. The proper placement of the tip of the catheter in the jugular bulb will be confirmed later by a postoperative lateral skull X-ray. SjvO2 (blood sample will be drawn slowly at a speed of 2ml per minute) will be measured before anesthesia, at extubation, 30, 60, 90, and 120 min after extubation.
16167770|NCT01642147|Procedure|Tumor removal surgery under general anesthesia|Surgery types include total or subtotal removal of tumors.For all surgical procedures, general anesthesia will be maintained with isoflurane (0.5-1.0 minimal alveolar concentration (MAC) expired), repeated boluses of fentanyl (1~2 µg/kg IV), and continuous vecuronium 50～70 IV. All patients will be mechanical ventilated with oxygen. During anesthesia, blood pressure and heart rate will be kept stable, within ±10% of the preoperative levels. Hematocrit (Hct) will be maintained higher than 30%. After surgery, tracheal extubation will be performed when patients regain full muscle strength, breathe spontaneously with acceptable oxygenation and normocapnia.
16167771|NCT01642147|Procedure|Radial artery catheterization|After local anesthesia, an intra-arterial pressure line(I.V. catheter and pressure line kit are both manufactured by Smiths Medical International Ltd. USA) will be inserted in radial artery. Sample blood will be drawn from the line before anesthesia, at tracheal extubation, and 30, 60, 90, 120 min after tracheal extubation.
16167772|NCT01642147|Procedure|Abdominal surgery under general anesthesia|For all surgical procedures, general anesthesia will be maintained with isoflurane (0.5-1.0 minimal alveolar concentration (MAC) expired), repeated boluses of fentanyl (1~2 µg/kg IV), and continuous vecuronium 50～70 IV. All patients will be mechanical ventilated with oxygen. During anesthesia, blood pressure and heart rate will be kept stable, within ±10% of the preoperative levels. Hematocrit (Hct) will be maintained higher than 30%. After surgery, tracheal extubation will be performed when patients regain full muscle strength, breathe spontaneously with acceptable oxygenation and normocapnia.
16167773|NCT01642134|Drug|aspirin+clopidogrel (Duoplavin)|100 mg aspirin ;75 mg clopidogrel 3º months
16167774|NCT01642121|Other|laboratory biomarker analysis|Correlative studies
16167775|NCT01642108|Drug|Sitagliptin|50 mg once per day
16167776|NCT01642095|Other|Laboratory Biomarker Analysis|Correlative studies
16167777|NCT01642082|Biological|Dalantercept|Given SC
16167778|NCT01642082|Other|Laboratory Biomarker Analysis|Correlative studies
16167779|NCT01642069|Other|laboratory biomarker analysis|Correlative studies
16167780|NCT01642056|Drug|EPI-743|This medication is used to treat disorders of energy metabolism such as mitochondrial diseases. It does not correct the inherited disorder of energy metabolism or mitochondrial diseases. EPI-743 is structurally related to Vitamin E and can be broadly classified as an antioxidant.
16167781|NCT01642056|Drug|Placebo|
16167782|NCT01642030|Drug|Placebo|Intravenous injection of approximately 5 mL administered via slow push over 5 minutes. Given 4 injections during the session with each injection separated by 1.5 hours.
16167783|NCT01642030|Drug|Hydromorphone|Intravenous injection of approximately 5 mL administered via slow push over 5 minutes. Given 4 injections during the session with each injection separated by 1.5 hours.
16167784|NCT01642030|Drug|Buprenorphine|Intravenous injection of approximately 5 mL administered via slow push over 5 minutes. Given 4 injections during the session with each injection separated by 1.5 hours.
16167785|NCT01642017|Drug|Pazopanib|Pazopanib will be administered orally at the starting dose of 400 mg/day in 28-days cycles ; barring limiting toxicities the dose of pazopanib will escalate in several steps (a maximum of 3 dose levels are defined : 400, 600 and 800 mg/day). The pazopanib will be administered at the same dosa until disease progression.
16167786|NCT01642004|Biological|Nivolumab|
16167787|NCT01642004|Drug|Docetaxel|
16167788|NCT01641991|Biological|BioThrax®|BioThrax® is a sterile, milky white suspension made from cell free filtrates of microaerophilic cultures of an avirulent, nonencapsulated strain of Bacillus anthracis, will be administered as a 0.50mL IM injection 6 month boost for all groups
16167789|NCT01641991|Biological|BioThrax®|BioThrax® will be administered as: Arm A: 0.50mL SC injection on Days 0 and 14; Arm B: 0.50mL SC injection on Days 0 and 28; Arm C: 0.50mL SC injection on Days 0, 14 and 28; Arm D: 0.25 mL SC injection on Days 0, 14 and 28.
16167790|NCT01641965|Device|Home pressure ventilator model Vivo 40 (BREAS Medical AB)|Nocturnal non invasive ventilation (Vivo 40)with minimum pressure support of 10 cm H2O (IPAP 14, EPAP 4). Parameters will be adjusted according to tolerance and to achieve PaCO2 < 45 mmHg and improve symptoms.
16167791|NCT01641952|Drug|Rituximab|Rituximab at a dose determined by the investigator, guided by the recommendation in the Summary of Product Characteristics.
16167792|NCT01641939|Drug|Taxane|Standard taxane (docetaxel 75 mg/m^2 IV every 3 weeks or paclitaxel 80 mg/m^2) IV once a week according to investigator choice.
16167793|NCT01641939|Drug|trastuzumab emtansine|trastuzumab emtansine 3.6 mg/kg IV every 3 weeks
16167794|NCT01641939|Drug|trastuzumab emtansine|trastuzumab emtansine 2.4 mg/kg IV once a week
16167795|NCT01641926|Biological|PEG-Intron™|PEG-Intron subcutaneously (SC) once weekly for a total of 48 weeks
16167796|NCT01641926|Biological|PEGASYS™|PEGASYS subcutaneously (SC) once weekly for a total of 48 weeks
16167797|NCT01641913|Other|Absorbable sugars|Lactulose (1,000 mg) and mannitol (200 mg). For the liquid formulation, these sugars will be administered in 250 ml of water. After oral ingestion of the sugars in liquid form, urine will be collected every 30 minutes for the first 2 hours.
16167798|NCT01641900|Drug|eszopiclone|3 mg of eszopiclone for two consecutive nights (Baseline Night and Experimental Night). Sleep spindle density (primary outcome) is measured for both nights. Memory consolidation (secondary outcome) is measured over Experimental Night.
16167799|NCT01641900|Drug|placebo|placebo capsule for two consecutive nights. (Baseline Night and Experimental Night). Sleep spindle density (primary outcome) is measured for both nights. Memory consolidation (secondary outcome) is measured over Experimental Night.
16167800|NCT01641887|Other|Decision Aid|Patients will use a decision aid administered on a computer.
16167801|NCT01641874|Procedure|Exercise|Directional specific exercise
16167802|NCT01641874|Procedure|Evidence based exercise|Quadriceps exercises and advice on aerobic exercises. Exercises are based on current evidence for the best exercises for osteoarthritic knee
16167803|NCT01641861|Device|Papacarie®|Papacarie® is chemo-mechanical method for caries removal
16167805|NCT01641848|Device|INBONE™ Total Ankle Prosthesis with Long Talar Stem|INBONE™ Total Ankle Prosthesis with Long Talar Stem when used with a Calcaneal Stem
16167806|NCT01641822|Drug|AZLI|Aztreonam for Inhalation Solution (AZLI) 75 mg 3 times daily combined with diluent administered using an eFlow nebulizer
16167807|NCT01641822|Drug|Placebo to match AZLI|Placebo to match AZLI 3 times daily combined with diluent administered using an eFlow nebulizer
16167808|NCT01641822|Drug|Tobramycin inhalation solution|Tobramycin inhalation solution (TIS) 300 mg 2 times daily using a PARI® LC Plus nebulizer and DeVilbiss Pulmo-Aide® air compressor
16167809|NCT01641809|Drug|GSK1265744 10 mg|GSK1265744 10 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase of the study and in combination with Rilpivirine 25 mg in the Maintenance Phase of the study.
16167810|NCT01641809|Drug|GSK1265744 30 mg|GSK1265744 30 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase of the study and in combination with Rilpivirine 25 mg in the Maintenance Phase of the study.
16167811|NCT01641809|Drug|GSK1265744 60 mg|GSK1265744 60 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase of the study and in combination with Rilpivirine 25 mg in the Maintenance Phase of the study.
16167812|NCT01641809|Drug|Efavirenz 600 mg|Efavirenz 600 mg will be administered orally once daily in combination with investigator-selected background NRTIs in the Induction Phase and Maintenance Phase of the study.
16167813|NCT01641809|Drug|Rilpivirine 25 mg|Rilpivirine 25 mg will be administered orally once daily in combination with GSK1265744 10 mg, 30 mg and 60 mg in the Maintenance Phase of the study.
16167814|NCT01641809|Drug|Placebo|Placebo matching to GSK1265744 will be administered along with GSK1265744 10 mg and 30 mg in the Induction phase and Maintenance phase of the study.
16167815|NCT01641809|Drug|Abacavir/Lamivudine (ABC/3TC) or Tenofovir/Emtricitabine (TDF/FTC)|The background dual NRTI therapy for all arms in the Induction Phase and Efavirenz 600 mg arm in the Maintenance Phase will be either abacavir 600 mg + lamivudine 300 mg (ABC/3TC) or tenofovir 300 mg + emtricitabine 200 mg (TDF/FTC) as selected by the Investigator.
16167816|NCT01641796|Drug|Paromomycin|Paromomycin Topical Cream applied to all lesions once a day for 20 days
16167817|NCT01641783|Drug|nanoparticle Albumin-Bound paclitaxel|nanoparticle Albumin-Bound paclitaxel:125mg/m2 d1 iv
16167818|NCT01641770|Other|Nutritional beverage 10003RF|2 sachets per day
16167819|NCT01641770|Other|Dietary Counseling|Guidelines for dietary counseling include energy and nutrient requirements.
16167820|NCT01641770|Other|Dietary Counseling|Guidelines for dietary counseling include energy and nutrient requirements.
16167821|NCT01641757|Procedure|non-surgical periodontal therapy|dental scaling and root planing of full mouth will be done
16167822|NCT01641744|Behavioral|Systematic Training for Effective Parenting (STEP)|Parenting skills training class, 1x/week, 12 weeks
16167823|NCT01641744|Behavioral|Group Attachment Based Intervention (GABI)|Parent-child group, 3x/week, 26 weeks
16167824|NCT01641731|Other|Cow's milk|"Group I: Increase 2 mL until 10 mL, 10 mL until 50 mL, 20 mL until 100 mL and 50 mL until 200 mL was reached.
~Groups II and III: Doubling dose until 1 mL, increase 2 mL until 20 mL, 5 mL until 50 mL, 10 mL until 100 mL and 20 mL until 200 mL was reached."
16167825|NCT01641718|Drug|Tissue glue|The mesh fixation for the transabdominal preperitoneal patch plastic repair will be performed with 2 mL of tissue glue.
16167826|NCT01641718|Device|Staples|The mesh fixation for the transabdominal preperitoneal patch plastic repair will be performed with ProTack (Covidien) and Securestrap (Ethicon) staples.
16167827|NCT01641692|Drug|GSK573719 Active treatment or Placebo|Eligible subjects will be randomised to a sequence of three treatments from 8 possible arms: 7 active drug doses (15.6mcg, 31.25 mc, 62.5mcg 125mcg or 250mcg GSK573719 once daily; 15.6mcg or 31.25 mcg GSK573719 taken twice daily) or matched placebo.
16167828|NCT01641692|Procedure|GSK573719 (Sub-group cohort)|Subjects at selected Sub-group sites (approximately 30% of the total population) will have additional serial assessments and procedures (including blood and urine samples for pharmacokinetic analysis) at the start (Day 1) and at the end (Days 14 and 15) of each treatment period. On Day 14 of each treatment period subjects will remain overnight at the clinic for 24-hour assessments, including spirometry, ECGs, and 24-hour Holter monitoring.
16167829|NCT01641692|Drug|Salbutamol/Albuterol|Salbutamol/Albuterol, short-activing beta agonist provided to all subjects to be taken as needed for the relief of asthma symptoms.throughout the study period, including washout periods
16167830|NCT01641666|Drug|Boceprevir|Boceprevir will be dosed orally at a dose of 800 mg three times daily (TID) for a total daily dose of 2400 mg.
16167831|NCT01641666|Drug|Peginterferon Alfa-2b 1.5 mcg/kg/week|Peginterferon alpha-2b will be administered subcutaneously at a dose of 1.5 mcg/kg each week.
16167832|NCT01641666|Drug|Ribavirin|Ribavirin will be administered orally at a dose of 800 mg/day to 1400 mg/day in two divided daily doses (BID).
16167833|NCT01641653|Other|Normal saline|Normal saline 2cc. one dose prior to OR
16167834|NCT01641653|Drug|Midazolam|1-2.5 mg
16167835|NCT01641640|Drug|Sofosbuvir|Sofosbuvir 400 mg tablet administered orally once daily
16167836|NCT01641640|Drug|RBV|Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
16167837|NCT01641640|Drug|PEG|Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
16167838|NCT01641627|Procedure|proprioceptive stimulation|tendon vibrations and plantar stimulation with a therapeuthic orthosis, 4x30 min/day during 14 days
16167839|NCT01641614|Procedure|Mitral valve replacement|Mitral valve replacement (MVR) was performed using a metallic or bioprostheses substitution by interrupted suture. For the beating heart the prostheses was functionally tested before removal of the retrograde perfusion catheter and for the arrested heart the prosthesis was artificially tested by pumping saline into the left ventricle. The tricuspid valve repair was done following De Vegas' technique in both groups
16167897|NCT01641224|Device|Tangerine Peel|Tangerine Peel (~10g)
16167898|NCT01641224|Drug|Ledebouriella Root|Ledebouriella Root (~10g)
16167899|NCT01641224|Drug|Radix codonopsitis|Radix codonopsitis (~10-15g)
16167900|NCT01641224|Drug|Radix curcumae|Radix curcumae (~10g)
16167901|NCT01641224|Drug|Fingered citron|Fingered citron (~10g)
16167840|NCT01641614|Procedure|mitral valve replacement|Mitral valve replacement (MVR) was performed using a metallic or bioprostheses substitution by interrupted suture. For the beating heart the prostheses was functionally tested before removal of the retrograde perfusion catheter and for the arrested heart the prosthesis was artificially tested by pumping saline into the left ventricle. The tricuspid valve repair was done following De Vegas' technique in both groups
16167841|NCT01641601|Device|Outpatient transcervical Foley balloon|A 30 cc transcervical Foley balloon will be placed in the outpatient setting prior to labor induction.
16167842|NCT01641588|Behavioral|posture: sitting or standing|Intervention: postural position - whether seated or standing. The person carries out a battery of cognitive executive functioning assessments delivered via a laptop and carried out with the laptop keyboard while either seated or standing.
16167843|NCT01641575|Drug|CO-1.01 and Cisplatin|CO-1.01 administered over 30 minutes followed by 75 mg/ml Cisplatin over 2 hours (both intravenous) on C1D1. CO-1.01 administered intravenously over 30 minutes on C1D8.
16167844|NCT01641549|Procedure|Emergency surgery|Emergency surgery (valve replacement or thrombectomy)
16167845|NCT01641549|Drug|Fibrinolytic therapy|Streptokinase (SK) at a dose of 0.25MU over 30 minutes followed by a 0.1MU/ hour infusion, or other fibrinolytic agent at standard doses
16167846|NCT01641536|Genetic|HB-110|Each patient will be administered HB-110 by Electroporation for 20 weeks based on the protocol and take one pill of Entecavir(0.5 mg) per day during the study period. The Dose of HB-110 will be determined by the classical 3+3 dose escalation schedule and dose levels are 1mg, 2mg, 4mg respectively. The number of patients will be ranged from 9 to 18.
16167847|NCT01641523|Device|CustomBone Service|customized hydroxyapatite cranial prosthesis
16167848|NCT01641510|Drug|Prasugrel|Loading with prasugrel 30 mg followed by daily administration of prasugrel 5 mg
16167849|NCT01641510|Drug|Clopidogrel|Loading with clopidogrel 600 mg followed by daily administration of clopidogrel 75 mg
16167850|NCT01641497|Radiation|3D conformational radiation|25 * 1.8 Gy in 5 weeks (=45 Gy)
16167851|NCT01641497|Radiation|IMRT|25 * 1.8 Gy in 5 weeks (=45 Gy)
16167852|NCT01641484|Procedure|local control at 19.8Gy|Day 14, full body TEP and pelvis MRI
16167853|NCT01641471|Device|EMPI Select TENS|The unit is capable of 0-60 milliamps of output current.
16167854|NCT01641471|Device|Placebo EMPI Select TENS|The sham unit appears identical to the Active TENS unit, yet is created to deliver low-level, non-therapeutic electrical stimulation.
16167855|NCT01641458|Other|5FU and capecitabine (Xeloda®) dosing based on DPYD genotype|Multiplex amplification of each sample is performed in an individual well of a 24-well plate using a Mastercycler platform. Template and Platinum Taq Polymerase (Life Technologies, Carlsbad, California) are added to an analyte-specific amplification mix (AutoGenomics Inc., Carlsbad, California). After amplification, the plate is transferred into the Infinity analyzer (AutoGenomics Inc.), followed by primer extension and hybridization of detection primers to individual oligonucleotides arrayed on the Bio-FilmChip. After hybridization, the BioFilmChips are washed and scanned in the Infiniti optics module. The Autogenomics DPYD assay is used to detect the presence of the four risk alleles (IVS14+G>A, c.1679T>G, HapB3/c.1129-5923C>G and c.2846A>T).
16167856|NCT01641458|Other|Therapeutic drug monitoring of 5FU|Repeated PK plasma sampling is done in all patients receiving 5FU. Blood is taken from venipuncture into one 5 ml heparin tube and into one 3 ml EDTA tube for the analysis of 5FU steady-state plasma concentrations in every (2-weekly) treatment cycle. Special attention has to be paid not to take PK blood from the site of drug infusion. For 5FU, PK sampling is done two hours before the calculated end of the 5FU pump on day 3 of every treatment cycle. The quantitative 5FU exposure expressed as the area-under-the concentration-time curve in mg•h/L is calculated from the measured steady-state plasma concentrations of 5FU and the duration of 5FU infusion. In all patients, 5FU doses for the second and subsequent administrations are adjusted to target a 5FU AUC between 20 and 30 mg•h/L
16167857|NCT01641445|Drug|Topiramate|Topiramate (200 mg daily)
16167858|NCT01641445|Drug|Placebo|"Matching placebo capusules (sugar pills"
16167859|NCT01641432|Behavioral|Tonic and Phasic Attention Training|"The Tonic and Phasic Alertness treatment task (TAPAT) consist of two consecutive rounds of a 12-minute continuous performance task in which continually varying, rich visual (e.g., scenes, objects, faces) or auditory stimuli (tones or complex sounds) are briefly displayed and participants are required to respond via a button press when they see a non-target item (90% of trials) or withhold button-press responding when the item is a pre-determined target item (10% of trials). Presentation of the target item is non-predictive and infrequent, disallowing the development of an executive strategy. Participants simply sustain attention to the task over a prolonged period of time (tonic attention), ignoring distractions, and inhibiting the pre-potent motor response when they see a target item (phasic attention).
~Following the 24 minutes of TAPAT treatment participants will undergo one additional computer-based cognitive exercise, Multiple Object Tracking (MOT), for an additional 12 minutes."
16167860|NCT01641432|Behavioral|Active Comparator|Computer games chosen from a list of progressive visual/audiovisual games from the top-100 game list: sporcle.com. Training duration will be similar to that of experimental training.
16167861|NCT01641419|Drug|Placebo|2 ml of saline added to 30 ml of ropivacaine 0.5% solution for nerve block
16167862|NCT01641419|Drug|Dexamethasone 4 mg|2 ml of dexamethasone 4 mg solution added to 30 ml of ropivacaine 0.5% solution for nerve block
16167863|NCT01641419|Drug|Dexamethasone 8 mg|2 ml of dexamethasone 8 mg solution added to 30 ml of ropivacaine 0.5% solution for nerve block
16167864|NCT01641406|Drug|Docetaxel, Epirubicin, Cyclophosphamide/Navelbine, Capecitabine, Trastuzumab, Bevacizumab|ER-(Triple Negative and ER-PR+Her-2-):Patients who respond to the first 4 courses of TEC with a Complete Remission will receive 4 more courses of TEC. Patients who respond to the first 4 courses of TEC with a Partial Remission or Stable Disease will then have their treatment changed to the non-cross resistant NAX regimen.Courses will be repeated every 21 days according to blood counts.A total of 4 courses will be given.
16167865|NCT01641406|Drug|Docetaxel, Epirubicin, Cyclophosphamide/Navelbine, Capecitabine, Trastuzumab, Bevacizumab|"Her-2 positive cases:Patients who respond to 4 courses of TEC with either a partial or complete remission will then receive 4 additional courses of Docetaxel plus Herceptin, and upon completion of the 4th course of DH they will undergo definitive surgery.A total of 4 courses will be given. Courses will be repeated every 21 days according to blood counts. Patients whose response after 4 courses of TEC is either stable disease or progression, will be treated with NTX."
16323166|NCT00475969|Drug|duloxetine|
16167866|NCT01641406|Drug|Docetaxel, Epirubicin, Cyclophosphamide/Navelbine, Capecitabine, Trastuzumab, Bevacizumab|ER+ Cases(ER+PR+Her-2- and ER+PR-Her-2-):After the first course of TEC if the SUV of the primary tumor is >5%, treatment will be TEC x 4 courses. If the Oncotype is low, patients will be switched to hormonal therapy x 6 months. If the Oncotype result is intermediate/high, patients will be NAX chemotherapy x 4 courses. If the SUV post course #1 TEC is <5%, subsequent treatment will depend on the Oncotype.If the Oncotype is low, the treatment will be hormonal therapy x 6 months. If the Oncotype is intermediate/high , the treatment will be NAX chemotherapy x 4. Surgery will be performed 6 weeks after the 4th course of NAX chemotherapy.
16167867|NCT01641393|Drug|EUR-1008 25,000 Units|EUR-1008 25,000 Units is a PEP with pancreas powder as the active ingredient.18 Pancreas powder contains various enzymes having proteolytic, lipolytic, and amylolytic activity. Each capsule contains approximately 25,000 Ph. Eur. lipase units. EUR-1008 25,000 consists of orally administered capsules containing enteric-coated beads.
16167868|NCT01641393|Drug|Kreon 25,000 Units|Kreon 25,000 is a PEP consisting of porcine-derived pancreatic enzymes.18 Each capsule contains approximately 25,000 Ph. Eur. lipase units. Kreon 25,000 consists of orally administered capsules containing enteric-coated spheres.
16167869|NCT01641380|Behavioral|Text Messaging Intervention|"Online enrollment in the Compliance for Life® (CFL) system through iReminder)
~Welcome Message 24 hrs after enrollment
~Appointment Reminder prior to 3 month injection cycles
~Monthly health reminders i. Condom use ii. Weight control iii. Side Effect Management 5.6-month STD testing reminder
~6.Call for missed appointment or no reply to appointment reminder (or other text message)"
16167870|NCT01641367|Drug|Darunavir|Participants were administered darunavir orally as one 600 mg tablet twice a day (1200 mg per day) with food (taken with Ritonavir 100 mg twice a day [200 mg per day])
16167871|NCT01641367|Drug|Etravirine|Patients were administered Etravirine orally as two 100 mg tablets or one 200 mg tablet twice a day (400 mg per day) following a meal.
16167872|NCT01641367|Drug|Emtricitabine/tenofovir disoproxil fumarate|Patients were administered FTC/TDF orally as one fixed dose combination tablet (FTC 200 mg/TDF 300 mg) once daily, with or without food.
16167873|NCT01641367|Drug|Raltegravir|Participants were administered Raltegravir orally as one 400 mg tablet twice daily (800 mg per day), with or without food
16167874|NCT01641367|Drug|Second line ART regimens - based on a boosted protease inhibitor (bPI) plus two nucleoside analogues (NRTIs)|LPV/r and ATV/r were the preferred bPIs for second-line ART. TDF + (3TC or FTC) or AZT + 3TC were the most frequent NRTI backbones. Cohort A did not include any of the new drugs; therefore, it is distinct from Cohorts B, C, and D.
16167875|NCT01641367|Drug|Study provided drugs according to patient resistance profile (DRV, ETR, RTV, FTC/TDF) + any in country available drug as applicable & available|For Cohort D, in many situations a participant received the same regimen that patients are getting in Cohorts B and C if that was the best combination that can be obtained according to his/her resistance profile and drug availability (as for many countries there were no further drug options beyond the available study drugs).
16167876|NCT01641367|Other|SOC adherence versus SOC+CPI adherence|"not participating in the adherence randomization; OR
~randomized to SOC adherence; OR
~randomized to SOC+CPI adherence."
16167877|NCT01641354|Procedure|Hemiepiphysiodesis|Partial closure of growth plate to correct deformity
16167878|NCT01641341|Drug|Bifidobacterium infantis|once a day for seven to eight weeks
16167879|NCT01641341|Drug|Pancrelipase|Pancrelipase (one capsule prior to meals or snacks)
16167880|NCT01641341|Drug|Nitazoxanide|Nitazoxanide (500mg twice a day for 7 days)
16167881|NCT01641341|Drug|Placebo|Placebo capsule will not contain active treatment ingredients.
16167882|NCT01641328|Behavioral|Cogntive Activation Training|Mindfulness-based stress reduction - 30 minutes / class x 3 classes / week; optional home practice Tai Chi - 30 minutes / class x 3 classes / week; optional home practice Computer-based cognitive training - 20 minutes / class x 3 classes / week; optional home practice
16167883|NCT01641328|Behavioral|Waitlist Control / Home-based training|Computer-based cognitive training - 20 minutes / day Daily walking - 20 minutes / day Biofeedback relaxation Training - 20 minutes / day
16167884|NCT01641315|Biological|rabies vaccine|"Group 1: rabies vaccination was given to rabies exposed victims on day 0,3,7,14,28 with ERIG on day 0.
~Group 2: rabies vaccination was given to healthy volunteers on day 0,3,7,14 with ERIG on day 0.
~Group 3: rabies vaccination was given to healthy volunteers on day 0,3,7,28 with ERIG on day 0."
16167885|NCT01641289|Drug|Paracetamol|>50kg: Paracetamol 1gm PO/NG q6hourly for 72hours and afebrile for 24h (maximum total dose 4g/24 hours) plus intravenous Artesunate <50kg: Paracetamol 12.5-15mg/kg/dose q6hourly for 72hours and afebrile for 24h (maximum total dose 5 doses/24hours;75mg/kg) plus intravenous Artesunate
16167886|NCT01641289|Drug|No Paracetamol|"No paracetamol + Intravenous Artesunate
~If temperature > 40°C, ibuprofen PO/PR will be administered in the absence of renal impairment and dehydration; 500mg paracetamol PO/PR will be administered in the presence of renal impairment or dehydration. Dengue testing will be done prior to the administration of ibuprofen."
16167887|NCT01641276|Device|Low intensity amplitude-moduled electromagnetic fields|Patients in each arm will be exposed to 30 min of amplitude-moduled low intensity electromagnetic fields only one time.
16167888|NCT01641263|Behavioral|Sleep Education Therapy|Each 2-hour session, held once a week for 8 weeks, consists of a 60-minute video presentation followed by a 60-minute question-and-answer discussion
16167889|NCT01641263|Behavioral|Cognitve Behavioral Therapy for Insomnia|For each 2-hour session held once a week for 8 weeks, the CBT treatment manual will outline objectives, patient skills, and treatment activities. Therapists will direct role-playing and other skill-development exercises that will be designed to increase patients' self-efficacy in managing their insomnia. Homework assignments will be planned weekly to ensure practice and skill application.
16167890|NCT01641250|Drug|RO5429083|Multiple escalating doses
16167891|NCT01641250|Drug|cytarabine|1000 mg/m2 iv daily for 5 consecutive days, up to 4 cycles
16167892|NCT01641237|Drug|sodium fluoride|fluoride as sodium fluoride
16167893|NCT01641237|Drug|no added fluoride in a silica base|no added fluoride
16167894|NCT01641224|Drug|Pinaverium|To test the effectiveness and safety of the formula for pain and diarrhea, we will randomly assign patients into one 3 groups: Pinaverium, TCM (Formula for pain and diarrhea) group, and placebo group, and treat them accordingly.
16167895|NCT01641224|Device|Atractylodes|Atractylodes (~10-15g)
16167896|NCT01641224|Device|Paeonia Lactiflora|Paeonia Lactiflora (~15-30g)
16167904|NCT01641211|Behavioral|Meducation device technique video|2-minute video that displays proper inhaler, diskus, and turbuhaler technique. The video will only be watched once at the medical visit. Children in this group will be given a wallet card so they can access the video via the Internet after leaving the asthma clinic.
16167905|NCT01641211|Other|Nutrition video|Children in this group will watch a 2-minute nutrition video.
16167906|NCT01641198|Device|Configuration 1|B placed at sites 2 and 5, SW placed at sites 1 and 4, SC placed at site 3
16167907|NCT01641198|Device|Configuration 2|B placed at site 3, SW placed at sites 2 and 5, SC placed at sites 1 and 4
16167908|NCT01641198|Device|Configuration 3|B placed at sites 1 and 4, SW placed at site 3, SC placed at sites 2 and 5
16167909|NCT01641185|Procedure|radiation|radiation with protons or carbon ions
16167910|NCT01641172|Procedure|Dexa scan|"the DEXA scan to measure bone and fat will be performed one time in the healthy controls and the patients participating in the cross sectional part of the study.
~The patients in the longitudinal part of the study will have a DEXA scan at baseline, 1 month after the end of chemotherapy and after 1 year."
16167911|NCT01641172|Procedure|audiogram|"the audiogram will be performed one time in the healthy controls and the patients participating in the cross sectional part of the study.
~The patients in the longitudinal part of the study will have an audiogram at baseline, 1 month after the end of chemotherapy and after 1 year."
16167912|NCT01641172|Procedure|measurement of heart rate variability and baroreflex sensitivity|"the measurements (continuous assessment of heart rate and blood pressure using an non-invasive Finapress device) during 30 minutes will be performed one time in the healthy controls and the patients participating in the cross sectional part of the study.
~The patients in the longitudinal part of the study will have those measurements taken at baseline, 1 month after the end of chemotherapy and after 1 year."
16167913|NCT01641172|Procedure|Glucose tolerance assessment|"Glucose tolerance will be assessed by drinking glucose water and measuring glucose at baseline and 2 hours later. It will be performed one time in the healthy controls and the patients participating in the cross sectional part of the study.
~The patients in the longitudinal part of the study will have an assessment at baseline, 1 month after the end of chemotherapy and after 1 year."
16167914|NCT01641172|Dietary Supplement|oral nutrition supplements|a set of 10 Oral Nutrition Supplements (ONS) will be offered combined with a questionnaire to measure appreciation and preference for these food products. All these tests and questionnaires will be performed longitudinally (before the first chemotherapy, on day 7 of the first course, before the second course, on day 7 of the second course, 1 month after start of the last course, 7 months after the start of chemotherapy, and 1 year after the start of chemotherapy) and cross-sectional (1, 3, 5 and 7 years after chemotherapy).
16167915|NCT01641172|Behavioral|Two day food records|Two day food records will be used to investigate the actual dietary intake before the first and second course, during (on day 5 and 6) first and second course, 1 month after start of the last course, 7 months after the start of chemotherapy, and 1 year after the start of chemotherapy.
16167916|NCT01641172|Behavioral|Food Frequency Questionnaire|A Food Frequency Questionnaire (FFQ) will be used to investigate the usual dietary intake before the start of the first course, before and after the second course, 1 month after start of the last course, seven months after the start of chemotherapy, and 1 year after the start of chemotherapy (longitudinal), and 1, 3, 5 and 7 years after chemotherapy (cross-sectional).
16167917|NCT01641159|Drug|Buspirone|Study participants will be randomly assigned to receive either buspirone or matching placebo. Following dose escalation, the target at study day 10 is to achieve the highest tolerated dose not exceeding 60 mg. Participants who are unable to reach the 60 mg dose or who need to be reduced from 60 mg due to tolerability will be maintained on 15 mg, 30 mg, or 45 mg, whichever is the highest dose tolerated.
16167918|NCT01641159|Drug|Placebo|Study participants will be randomly assigned to receive either buspirone or matching placebo. Placebo tablets will be identical in color and size to the buspirone tablets.
16167919|NCT01641146|Behavioral|Enhanced Sexual Health Intervention for Men (ES-HIM)|ES-HIM is a six-session intervention for HIV-positive Black bisexual men who have histories of child sexual abuse. Guided by cognitive behavioral approaches and an ecological framework, ES-HIM effects sexual behavior change and psychological health improvement. Sexual risk reduction is framed from the perspective of being a triple minority (i.e., HIV-positive, ethnic and sexual minority). Issues of stigma and social isolation were discussed in regard to these identities. Sexual ownership focusing on individual responsibility for one's health and well-being was prioritized along with caring for sexual partners, family and community. Decisions regarding sexual behaviors and consequences were framed within a culturally congruent social context. Topics included: 1) the influence of gender and ethnicity; (2) early socialization regarding gender and culture, as well as adult experiences; (3) HIV stigma; and (4) recognizing stressors, including histories of personal trauma.
16167920|NCT01641146|Behavioral|Health Promotion (HP) Comparison Arm|Health Promotion Intervention (HP) is the comparison arm. It is designed to control for the Hawthorne effect and reduce the likelihood that effects of ES-HIM could be attributed to special attention and group interaction. HP addresses health issues, including certain cancers, hypertension, diabetes, and heart disease, all of which are common among African American men, but did not focus on sexual behavior. Participants were taught that these diseases could be prevented by changing personal behaviors (e.g., increasing physical activity and healthy dietary practices, ceasing cigarette smoking and alcohol and drug abuse), or managed with early detection and screening behaviors.
16167921|NCT01641133|Biological|Synflorix (3-Dose)|3 doses administered intramuscularly
16167922|NCT01641133|Biological|Synflorix (2-Dose)|2 doses administered intramuscularly
16167923|NCT01641133|Biological|Synflorix (Single Dose)|1 dose administered intramuscularly
16167924|NCT01641133|Biological|Prevenar 13 (Single Dose)|1 dose administered intramuscularly
16167925|NCT01641133|Biological|Prevenar 13 (2-Dose)|2 doses administered intramuscularly
16167926|NCT01641120|Drug|Avonex|Intramuscular injection administered using 25 gauge or 30 gauge needle
16168002|NCT01640496|Drug|Vitamin D3|3000 IU Vitamin D3 tablets (Cholecalciferol) will be used. 28 pills per bottle. Subjects will be given 2 bottles to be taken for the duration of this study.
16168003|NCT01640496|Other|Placebo|Placebo will be given to subjects. 28 pills per bottle. Subjects will be given 2 bottles to be taken for the duration of this study.
16168039|NCT01640197|Dietary Supplement|Resveratrol|Transmax (Biotivia). 500mg (1 capsule) per day for 28 days.
16167927|NCT01641107|Drug|Ponatinib|"Treatment:
~Patients will receive daily oral administration of Ponatinib at a dose of 45 mg/day for 6 weeks (defined as one course) for 8 courses, same dose and schedule, for a total of 48 weeks. Each patient will be followed for the subsequent 24 months, every 3 month, providing survival information and monitoring serious adverse event. Each patient should be treated for a minimum of 6 weeks. Patients must be discontinued from the trial in the event of myocardial infarction or stroke, or for development or progression of arterial disease necessitating revascularization. Once a complete hematologic response has been achieved, with a platelet count ≥ 50x109/L, patients can be treated with aspirin and/or a statin as clinically indicated, at investigator discretion."
16167928|NCT01641081|Drug|Formoterol Fumarate in the Pressair DPI, Low Dose|Formoterol Fumarate in the Pressair DPI 6 micrograms, twice a day for 14 days
16167929|NCT01641081|Drug|Formoterol Fumarate in the Pressair DPI, High Dose|Formoterol Fumarate in the Pressair DPI 12 micrograms, twice a day for 14 days
16167930|NCT01641081|Drug|Foradil Aerolizer, Low Dose|Foradil Aerolizer 12 micrograms, twice a day for 14 days
16167931|NCT01641081|Drug|Foradil Aerolizer, High Dose|Foradil Aerolizer 24 micrograms, twice per day for 14 days
16167932|NCT01641081|Drug|Placebo|Placebo in the Pressair for 14 days
16167933|NCT01641068|Other|Cognitive Intervention|Participate in memory and thinking skills workshop
16167934|NCT01641068|Other|Educational Intervention|Participate in workshops focusing on increasing knowledge and education on the brain and cognition
16167935|NCT01641068|Procedure|Functional Magnetic Resonance Imaging|Undergo functional neuroimaging
16167936|NCT01641068|Other|Memory Intervention|Participate in memory and thinking skills workshop
16167937|NCT01641068|Other|Quality-of-Life Assessment|Ancillary studies
16167938|NCT01641068|Other|Questionnaire Administration|Ancillary studies
16167939|NCT01641055|Dietary Supplement|Salmon protein hydrolysate|2.5g salmon protein hydrolysate per day for 8wk.
16167940|NCT01641055|Dietary Supplement|Herring protein hydrolysate|2.5g herring protein hydrolysate per day for 8wk.
16167941|NCT01641055|Dietary Supplement|Cod protein|2.5g cod protein per day for 8wk.
16167942|NCT01641055|Dietary Supplement|Milk protein|2.5g milk protein per day for 8wk.
16167943|NCT01641042|Biological|Meningococcal vaccine GSK134612|2 doses of the vaccine administered intramuscularly in the anterolateral thigh muscle of the non-dominant leg for subjects aged 12 months to 2 years and in the deltoid of the non-dominant arm for older subjects.
16167944|NCT01641029|Other|No intervention|There is no intervention
16167945|NCT01641016|Drug|efavirenz|May be taken as 600mg tablet, 200mg tablet or as part of a combination pill
16167946|NCT01640990|Drug|Saline|30mins run-in period
16167947|NCT01640990|Drug|GW328267X (total dose of 12mcg)|8 mcg/h for 1.5 hours (total dose of 12mcg)
16167948|NCT01640990|Drug|GW328267X (total dose of 40mcg)|10 mcg/h for 4 hours (total dose of 40 mcg)
16167949|NCT01640977|Procedure|Open PLIF (posterior lumbar interbody fusion)|The PLIF procedure achieves access to the degenerated disc from the back of the spine.
16167950|NCT01640977|Procedure|MAS PLIF|The MAS PLIF technique is a minimally invasive variant of the traditional PLIF procedure. It is similarly performed through a single midline posterior incision but is conducted through a more medialized posterior approach.
16167951|NCT01640964|Drug|Terlipressin acetate|IV bolus injection
16167952|NCT01640964|Drug|Serelaxin (RLX030)|Part A2: IV infusion for 2-3 hours; duration of infusion depends on time required for completion of MRA data acquisition; Part B: IV infusion for approximately 2 hours
16167953|NCT01640951|Drug|AIN457 150 mg|(1 injection per dose) and placebo to Secukinumab 150 mg
16167954|NCT01640951|Drug|AIN457 300 mg|Secukinumab 150 mg (2 injections per dose)
16167955|NCT01640951|Drug|Placebo|
16167956|NCT01640925|Drug|Chlorhexidine gluconate|Chlorhexidine gluconate 2% solution applied topically for full body bathing once every 48 hours
16167957|NCT01640925|Other|Standard bathing|The patient will be bathed using standard bathing (non-medicated cloths or soap and water) daily.
16167958|NCT01640912|Drug|RXI-109|Single intradermal injection of RXI-109 at incision sites
16167959|NCT01640912|Drug|Placebo|Single intradermal injection of placebo at incision sites
16167960|NCT01640899|Device|Shoe Insoles|Shoe insoles is an orthotic devices which are used to prevent, relieve, or reduce pain in lower extremities. The insoles give a mechanical support for the body by put it in a good alignment.
16167961|NCT01640873|Drug|MK-8655|Participants will receive MK-8655 as a single dose on Day 1. Participants will receive MK-8655, once a day (q.d.), for 14 consecutive days (Day 3 through Day 16). MK-8655 doses may be adjusted downward based on the results of ongoing studies.
16167962|NCT01640873|Drug|Placebo|Participants will receive Placebo as a single dose on Day 1. Participants will receive Placebo, q.d., for 14 consecutive days (Day 3 through Day 16).
16167963|NCT01640847|Drug|High Intensity Focused Ultrasound (HIFU) in combination with ThermoDox|
16167964|NCT01640834|Drug|LY2409021|Administered orally
16167965|NCT01640834|Drug|Placebo|Administered orally
16167966|NCT01640834|Drug|Glucagon|Administered via intramuscular injection
16167967|NCT01640821|Behavioral|CdM? program|The program is conducted in small groups of 12 to 15 women for 14 weekly sessions (13 3h-evening sessions and 1 intensive-day session of 6 hours). Two health professionals (a registered dietician and a social worker or psychologist) lead the group. Sessions include lectures, guided self-examination and observations, group discussions, and practical exercises. Different topics are discussed during sessions such as enjoyment of physical activity and healthy nutrition, setting realistic objectives with regard to weight loss, and acceptation of their own and others' body image. A weekly food diary and group discussions are used to facilitate the recognition of internal cues of hunger and satiety and the identification of external influences on eating behaviors and food intake.
16167968|NCT01640808|Drug|NIK-333(peretinoin)|600mg (8 x 75mg capsules) orally, twice a day
16167969|NCT01640808|Drug|Placebo|Placebo (8 x Placebo capsules) orally, twice a day
16168004|NCT01640483|Other|psychodynamic techniques.|the patients go through a time-limited (50 sessions, 45 minutes, 2 sessions/week) experimental treatment which exists of a sequence of four A phases (control conditions), one B phase (supportive techniques only), one C phase (interpretative techniques only), and one BC phase (mixed supportive/interpretative techniques).
16323167|NCT00475969|Drug|placebo|
16167970|NCT01640782|Drug|Irinotecan, Leucovorin, 5-Fluorouracil, Docetaxel, Cisplatin|"Irinotecan (CPT-11) 180 mg/m2, given as 60 min. i.v. infusion on day 1 every 2 weeks followed by
~Leucovorin (LV) 100 mg/m2, given as a 2h i.v. infusion on days 1 and 2 every 2 weeks followed by
~5-Fluorouracil (5-FU) 400 mg/m2 given as bolus, and then 5-Fluorouracil (5-FU) 600 mg/m2 given as a 22h continuous infusion on days 1 and 2, every 2 weeks for 4 administrations.
~After 3 weeks from last infusion:
~Docetaxel (TXT) 75 mg/m2, given as a 1h i.v. infusion on day 1 followed by
~Cisplatin (CDDP) 75 mg/m2, given as a 1h i.v. infusion on.day 1, every 3 weeks, for 3 cycles."
16167971|NCT01640782|Drug|Leucovorin, 5-Fluorouracil|"Leucovorin (LV) 100 mg/m2, given as a 2h i.v. infusion on days 1 and 2 every 2 weeks followed by
~5-Fluorouracil (5-FU) 400 mg/m2 given as bolus, and then 5-Fluorouracil (5-FU) 600 mg/m2 given as a 22h continuous infusion on days 1 and 2, every 2 weeks for 9 administrations."
16167972|NCT01640769|Procedure|Image guided delivery of cardiac pacing leads.|Patients will be blindly randomized to image guided delivery of pacing leads during cardiac resynchronization therapy device implantation (study arm).
16167973|NCT01640769|Procedure|Standard delivery of cardiac pacing leads.|Patients will be blindly randomized to standard implantation of pacing leads during cardiac resynchronization therapy device implantation (control arm).
16167974|NCT01640756|Device|AqueSys Microfistula Implant|Placement of the AqueSys Microfistula Implant in the study eye
16167975|NCT01640743|Drug|Tacrolimus + Methylprednisolone|"Induction therapy:
~Methylprednisolone (500 mg), thymoglobulins (1.5 mg/Kg/die, beginning 1 hour before transplantation) and 1 mg/Kg/die during the following 3 days.
~Maintenance therapy:
~Tacrolimus dosage will be 0.2 mg/kg of body weight and will be administered approximately 12 hours after chirurgical intervention twice a day (mornings and evenings). Dosage will be adapted on individual basis in order to gain pre-dose blood dosages according to indicated plasmatic levels"
16167976|NCT01640743|Drug|Tacrolimus + Everolimus + Methylprednisolone|"Induction therapy:
~Methylprednisolone (500 mg), thymoglobulins (2.5 mg/Kg/die, beginning 1 hour before transplant) and Mycophenolate mofetil (1000 mg) and no immunosuppressive therapy for the following 3 days (WOFIE hypothesis), and for day 4-5-6 thymoglobulins (1.0 mg/Kg/die).
~Maintenance therapy:
~Tacrolimus dosage will be 0.1 mg/kg of body weight and will be administered approximately 12 hours after chirurgical intervention twice a day (mornings and evenings). Dosage will be adapted on individual basis in order to gain pre-dose blood dosages according to indicated plasmatic levels"
16167977|NCT01640730|Drug|Kanglaite Injection|30gm IV infusion 5 days a week for 3 weeks every 28 days
16167978|NCT01640704|Behavioral|Computerized reminders about treatment guidelines to providers who care for hypertensive patients|
16167979|NCT01640691|Biological|Pandemic Influenza Vaccine (H5N1)|"Inactivated whole-virion vaccine
~Administration route: Intramuscular Injection
~Dosing schedule: 2 injections - at Day 1 and Day 22 separately
~Dose(s): Each dose (0.5 mL) contains the 15 mcg hemagglutinin (HA) of influenza A (A/Vietnam/1194/2004)"
16167980|NCT01640678|Procedure|ReCell epidermal cell suspension grafting|According to current standard of care procedures the treatment site will be superficially abraded using an ablative laser (10,600nm CO2 laser) after which the prepared ReCell cell suspension will be sprayed on.
16167981|NCT01640678|Procedure|CO2 laser abrasion + UV-therapy|According to current standard of care procedures the treatment site will be superficially abraded using an ablative laser (10,600nm CO2 laser)
16167982|NCT01640665|Drug|Sorafenib|One cycle will consist of 4 weeks of treatment. The dose of Sorafenib will be 600 mg administered orally daily in divided doses.
16167983|NCT01640665|Drug|Capecitabine|Capecitabine will be given at a fixed dose of 2000 mg orally BID x 7 days every 14 days.
16167984|NCT01640652|Biological|MenPF-1.|A new vaccine against meningococcal disease.
16167985|NCT01640639|Drug|Thalidomide|Thalidomide, pill, 50 mg, once p.d., 6 weeks
16167986|NCT01640639|Drug|Placebo|Placebo, pill, once p.d., 6 weeks
16167987|NCT01640626|Other|Health Education package|Health Education package that covers key health messages about the proper personal hygiene practices will be given to school children in the intervention school. The package consisted of many items such as posters, comic book, song video, competitions, drawing activities, puppet show, etc.
16167988|NCT01640587|Drug|Mefloquine+Artesunate|One tablet of artesunate contains 40mg (Guilin Pharmaceutical Company, PRC). One tablet of mefloquine contains 250 mg mefloquine (Eloquine® (Medochemie Ltd., Cyprus) Standard three days regimen of artesunate-mefloquine given as 4mg/kg artesunate/day and 8 mg/kg of mefloquine/day on Days 0, 1 and 2
16167989|NCT01640587|Drug|Dihydroartemisinin-Piperaquine|DHA-Piperaquine (Duo-Cotecxin® Beijing Holley-Cotec Pharmaceuticals Co., Ltd, China) One tablet contains 40mg of dihydroartemisinin and 320 mg piperaquine. A weight-based regimen containing 2.4 mg/kg DHA and 20 mg/kg PPQ once daily for 3 days
16167990|NCT01640574|Drug|Dihydroartemisinin-Piperaquine|Dihydroartemisinin-piperaquine + Primaquine: DHA-P 7mg/kg/day dihydroartemisinin and 55mg/kg/day piperaquine daily for 3 days and Primaquine 1 mg/kg once daily for 7 days
16167991|NCT01640574|Drug|Dihydroartemisinin-Piperaquine|Dihydroartemisinin-piperaquine + Primaquine: DHA-P 7mg/kg/day dihydroartemisinin and 55mg/kg/day piperaquine daily for 3 days Primaquine 0.5 mg/kg daily for 14 days
16167992|NCT01640574|Drug|Chloroquine|Chloroquine + Primaquine: Chloroquine 10, 10, 5 and Primaquine 1 mg/kg once daily for 7 days
16167993|NCT01640574|Drug|Chloroquine|o Chloroquine + Primaquine: Chloroquine 10, 10, 5 and Primaquine 0.5 mg/kg daily for 14 days
16167994|NCT01640561|Behavioral|MISC|The Mediational Interventions for Sensitizing Caregivers
16167995|NCT01640561|Behavioral|UCOBAC|This nutrition/healthcare curriculum for children in poverty and affected by HIV was developed by a non-governmental organization (NGO) operating in Uganda called Uganda Community Based Association for Child Welfare (UCOBAC) with support from UNICEF.
16167996|NCT01640535|Drug|Montelukast + Levocetirizine|Tablet, Montelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg, Once daily (before bedtime)
16167997|NCT01640535|Drug|Levocetirizine|Tablet, Matching placebo of Montelukast sodium 10 mg + Levocetirizine dihydrochloride 5 mg, Once daily (before bedtime)
16167998|NCT01640535|Drug|Montelukast|Tablet, Montelukast sodium 10 mg + matching placebo of Levocetirizine dihydrochloride 5 mg, Once daily (before bedtime)
16167999|NCT01640522|Other|Collaborative Care|Collaborative care intervention to manage cancer-related symptoms
16168000|NCT01640522|Other|Enhanced usual Care|
16168001|NCT01640509|Radiation|treated by synchrotron radiation|treated by synchrotron radiation
16323328|NCT00474708|Drug|SSRI|
16168005|NCT01640470|Device|Assistive Technology Provision and Tune-Up Intervention|"The home based AT Provision, Updating and Tune-Up (ATPUT) Intervention will consist of 5 components: 1) identification and prioritization of problematic activities by the assistance user and his/her principal, cohabitating caregiver; 2) in-residence assessment of the daily activities and social participation and preferences of the assistance user; 3) detailed review of the AT and human assistance that are currently being used; 4) recommendations by an occupational therapist for possible changes in the personal assistance strategy; 5) negotiation of an ATPUT Personal Plan with the assistance user and her/his principal caregiver.
~The intervention occurs over a six week period and involves 3 to 6 visits from an occupational therapist."
16168006|NCT01640470|Device|Customary Care|Participants in the customary care group receive normal occupational therapy services.Occupational Therapy
16168007|NCT01640457|Drug|NOVOCART® Disc plus|Autologous Disc Chondrocyte Transplantation System (ADCT)
16168008|NCT01640457|Device|NOVOCART® Disc basic|ADCT (Media with no active cell component)
16168009|NCT01640444|Drug|FOLFIRI + bevacizumab|"Bevacizumab 5 mg/kg iv, followed by
~Irinotecan 180 mg/m2 iv administered over a period of 30-90 minutes, followed by
~Leucovorin (LV) 400 mg/m2 iv administered over a period of 2 hours, followed by
~5-FU 400 mg/m2 iv bolus, followed by
~5-FU 2,400 mg/m2 for 46 h continuous infusion. This treatment will start on day 1 and will be repeated every 2 weeks (1 cycle)."
16168010|NCT01640444|Drug|FOLFIRI + cetuximab|"Cetuximab in an initial 120-minute infusion on day 1 of 400 mg/m2, followed by 60-minute infusions of cetuximab at a dose of 250 mg/m2, once weekly
~FOLFIRI:
~Irinotecan 180 mg/m2 iv administered over a period of 30-90 minutes, followed by
~Leucovorin (LV) 400 mg/m2 iv administered over a period of 2 hours, followed by
~5-FU 400 mg/m2 iv bolus, followed by
~5-FU 2,400 mg/m2 for 46 h continuous infusion FOLFIRI will be given after the cetuximab infusion on day 1 of each period (every 2 weeks: 1 cycle)."
16168011|NCT01640431|Other|Lumbar stabilization exercises|The patients performed exercises for the transversus abdominis and lumbar multifidus muscles for an hour twice a week.
16168012|NCT01640418|Device|Mepilex® Border Sacrum dressings|Mepilex® Border Sacrum dressings
16168013|NCT01640405|Drug|modified FOLFOX6 + bevacizumab|"Bevacizumab 5 mg/kg iv, day 1, followed by
~Oxaliplatin 85 mg/m2 iv administered over a period of 2 hours, day 1, followed by
~5- Fluorouracil (FU)/Leucovorin (LV), day 1 and 2, as follow:
~LV 400 mg/m2 iv administered over a period of 2 hours, followed by
~5-FU 400 mg/m2 iv bolus, followed by
~5-FU 2.400 mg/m2 over 46 h continuous infusion. This treatment will start on day 1 and will be repeated every 2 weeks (1 cycle)."
16168014|NCT01640405|Drug|FOLFOXIRI + Bevacizumab|"Bevacizumab 5 mg/kg iv, followed by
~Irinotecan 165 mg/m2 iv administered over a period of 30-90 minutes, followed by
~Oxaliplatin 85 mg/m2 iv administered over a period of 2 hours, followed by
~LV 400 mg/m2 iv administered over a period of 2 hours, followed by
~5-FU 3,200 mg/m2 for 48 h continuous infusion. This treatment will start on day 1 and will be repeated every 2 weeks (1 cycle)."
16168015|NCT01640392|Behavioral|MyLife MyStyle group-level intervention|Three 1.5-hour HIV behavioral risk-reduction group sessions conducted with up to 12 young African American/Black men (ages 18-29 years) over a 1-3 week period.
16168016|NCT01640379|Behavioral|Technology Enhanced Community Health Nursing|"Text-messaging (twice daily medication reminders w/ positive adherence messages, positive sexual health messages throughout the 30 day treatment period)
~Enhanced community health nursing visit on day 3-5, includes evidence-based STI/HIV prevention component (Sister to Sister Teen)"
16168017|NCT01640366|Device|PICO|Single-use Negative Pressure Wound Therapy System
16168018|NCT01640340|Drug|aprepitant|Given by mouth
16168019|NCT01640340|Drug|palonosetron hydrochloride|Given IV(intervenous infusion)
16168020|NCT01640340|Drug|ondansetron|Given PO
16168021|NCT01640340|Drug|dexamethasone|Given PO
16168022|NCT01640327|Biological|Trivalent influenza virus vaccine (TIVf)|A single dose (0.5 mL) of vaccine supplied in prefilled syringes was administered intramuscularly in the deltoid muscle, preferably of the non dominant arm
16168023|NCT01640314|Biological|Cell derived subunit trivalent nonadjuvanted vaccine|A single 0.5 mL dose of the cell derived subunit trivalent nonadjuvated influenza vaccine (TIVc) supplied in prefilled syringes and administered intramuscularly in the deltoid muscle (preferably) of the non dominant arm.
16168024|NCT01640301|Biological|Aldesleukin|Given SC
16168025|NCT01640301|Drug|Cyclophosphamide|Given IV
16168026|NCT01640301|Drug|Fludarabine Phosphate|Given IV
16168027|NCT01640301|Other|Laboratory Biomarker Analysis|Correlative studies
16168028|NCT01640301|Biological|WT1-Sensitized Allogeneic T-Lymphocytes|Given IV
16168029|NCT01640288|Drug|Perfluorinated Gas/Oxygen Mixture|19-Fluorine (19F) MRI of the lungs with 21%/79% Oxygen/Perfluorinated Gas, ≤ 25 liters, gas, single visit, < 1 hour
16168030|NCT01640288|Other|High Resolution CT of the Chest|High Resolution CT of the Chest, single visit
16168031|NCT01640275|Drug|Propofol|patients randomized to the propofol arm of the study will receive general anesthesia with propofol
16168032|NCT01640275|Drug|Isoflurane|patients randomized to the isoflurane arm of the study will receive general anesthesia with isoflurane
16168033|NCT01640262|Other|Multiparametric magnetic resonance imaging (mMRI)|A mMRI is performed before treatment of the patient and is compared to the standard diagnostic tools for evaluating the clinical stage and diagnose of prostate cancer
16168034|NCT01640249|Drug|Placebo|Capsules administered orally
16168035|NCT01640249|Drug|LY3006072|Capsules administered orally
16168036|NCT01640223|Device|Dexcom7|patients will wear 2 Dexcom sensors 3 days before hospitalization.
16168037|NCT01640223|Device|Dexcom7|patients will wear 2 Dexcom sensor one day before hospitalization
16168038|NCT01640210|Device|JewelPUMP (insulin patch pump)|"The study will be proposed during the visit of selection.
~Visit of inclusion:
~This visit will take place after having received the consent of the patient. Women will be asked to achieve a pregnancy test. Patients will wear a JewelPUMP containing saline solution in parallel with their usual insulin pump. They will be trained to use JewelPUMP.
~Patients treated with insulin pump will be instructed to reproduce the same programming between their usual pump and the JewelPUMP, they will use in parallel.
~Volume infused will be evaluated during a period of basal and bolus with a precision scale.
~Patient monitoring: Patient have to come back to the centre every 24 hours for 3 days. Study visit:
~Patients will be asked to fill out a questionnaire of satisfaction to the JewelPUMPTM and Visual scales.
~Volume infused will be evaluated with a precision scale, by comparison of weight of JewelPUMP and patients' usual pump"
16168040|NCT01640197|Other|Placebo|Methyl Cellulose. 1 capsule taken once daily for 28 days.
16168041|NCT01640184|Procedure|Parathyroidectomy|sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery.
16168042|NCT01640184|Drug|Active vitamin D|CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines.
16168043|NCT01640184|Procedure|Ultrasonic ablation|CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively.
16168044|NCT01640171|Procedure|Xylocaine 2% Injectable Anesthetic|xylocaine 2% injection 0.1 cc
16168045|NCT01640171|Drug|Proparacaine Hydrochloride 0.5% Drop|Topical drop given first to the treated eye.
16168046|NCT01640171|Drug|Tetravisc 0.5% Gel|Gel applied to eye 3 times prior to treatment
16168047|NCT01640171|Drug|Acuvail|Anti-inflammatory drop given after treatment
16168048|NCT01640171|Drug|Intra-vitreal Anti-VEGF Drug|Intravitreal injection treating wet AMD or Diabetic Macular Edema or Retinal Vein Occlusion
16168049|NCT01640158|Other|Computerized Plasticity-based Adaptive Cognitive Training|Computerized plasticity-based adaptive cognitive training, up to 65 hours
16168050|NCT01640158|Other|Commercially available computerized training|Commercially available computerized training, up to 65 hours
16168051|NCT01640145|Dietary Supplement|Protein|Whey protein intake
16168052|NCT01640145|Other|Exercise|Unilateral low intensity exercise
16168053|NCT01640119|Dietary Supplement|Bicarbonate|bicarbonate administration
16168054|NCT01640106|Dietary Supplement|Omega-3|800 mg Omega 3 daily (600 mg DHA/200 mg EPA)
16168055|NCT01640106|Dietary Supplement|Placebo|Placebo is a combination of dietary plant-based oils in a paste containing no Omega-3 (EPA or DHA)
16168056|NCT01640093|Drug|Abiraterone acetate, 250 mg (uncoated, current commercial tablet)|Type=exact number, unit=mg, number=250, form=tablet, route=oral. Administered once under fasted conditions.
16168057|NCT01640093|Drug|Abiraterone acetate, 500 mg (coated, reformulated tablet)|Type=exact number, unit=mg, number=500, form=tablet, route=oral. Administered once under fasted conditions.
16168058|NCT01640093|Drug|Abiraterone acetate, 250 mg (coated, reformulated tablet)|Type=exact number, unit=mg, number=250, form=tablet, route=oral. Administered once under fasted conditions.
16168059|NCT01640093|Drug|Abiraterone acetate, 500 mg (coated tablet, slower in vitro dissolution)|Type=exact number, unit=mg, number=500, form=tablet, route=oral. Administered once under fasted conditions.
16168060|NCT01640080|Drug|Esketamine|Type= exact number, number= 0.20, unit= mg/kg, form= intravenous infusion, route= intravenous use. One single intravenous infusion of esketamine 0.20 mg/kg administered on Day 1 and Day 4.
16168061|NCT01640080|Drug|Esketamine|Type= exact number, number= 0.40, unit= mg/kg, form= intravenous infusion, route= intravenous use. One single intravenous infusion of esketamine 0.40 mg/kg administered on Day 1 and Day 4.
16168062|NCT01640080|Drug|Placebo|Form= intravenous infusion, route= intravenous use. One single placebo intravenous infusion administered on Day 1 and Day 4.
16168063|NCT01640067|Biological|Human Neural Stem Cells|Surgical microinjection of human neural stem cells on spinal cord of ALS patients
16168064|NCT01640054|Drug|Fostamatinib|Fostamatinib 100mg once daily
16168065|NCT01640041|Device|Radio-frequency Microstiumulator|All participants will receive leg implants and will be trained first in the clinical and subsequently perform stimulation-assisted exercises in the home - for an overall duration of 6 months post-implant. Subsequently, exercise programs will continue without stimulation. Patient condition will be assessed at 9, 12 and 24 months post-implant.
16168066|NCT01640015|Other|dietary intervention|a low frequency diet (3 meals/day) a high frequency diet (9 meals/day)
16168067|NCT01640002|Drug|Propantheline Bromide|15MG OF PROPANTHELINE BROMIDE, THREE TIMES DAILY FOR 02 MONTHS.
16168068|NCT01640002|Drug|Placebo|PLACEBO CAPSULE, 03 TIMES DAILY FOR 02 MONTHS
16168069|NCT01639911|Drug|Alisertib|Alisertib at the assigned dose by mouth (PO) twice a day for 7 days beginning on day 1 of a 21 day cycle.
16168070|NCT01639911|Drug|Pazopanib|Pazopanib at the assigned dose once a day continuously for the duration of treatment.
16168071|NCT01639898|Drug|Lenalidomide and dexamethasone|2 cycles of the lenalidomide-dexamethasone (Len-Dex) combination before radiation or intensive treatment
16168072|NCT01639898|Drug|Lenalidomide and dexamethasone|9 cycles of the Len-Dex combination
16168073|NCT01639885|Drug|Interferon Alfa-2b|1ug/kg (max 100ug) 7 days before and 22 days after first treatment with gemcitabine
16168074|NCT01639885|Drug|Interferon Alfa-2b|1ug/kg (max 100ug) 7 days before and 22 days after first treatment with gemcitabine
16168075|NCT01639885|Biological|p53 SLP|8.2.3 The p53 SLP vaccine consists of 9 synthetic 25-30 amino acids long overlapping peptides, spanning amino acids 70-235 of the wt-p53 protein (patent number WO2008147186). Peptides are prepared at the GMP facility of the Department of Clinical Pharmacy and Toxicology of the LUMC. At the day of immunization peptides (0.3 mg/peptide) were dissolved in dimethyl sulfoxide (DMSO, final concentration 20%) admixed with 20 mM phosphate buffer (pH7.5) and emulsified with an equal volume of Montanide ISA-51.The vaccine (2.7mL) is administered subcutaneously.
16168076|NCT01639872|Drug|Clozapine|Clozapine: target dose of 400mg per day with a maximum dose of 550mg per day
16168077|NCT01639872|Drug|Risperidone|Clozapine: target dose of 4mg per day with a maximum dose of 6mg per day
16168078|NCT01639859|Other|Elastography|The elastography in vivo will be performed before the prostatectomy. The elastography ex vivo will be performed after radical prostatectomy.
16168079|NCT01639846|Drug|RX-10045|RX-10045 Ophthalmic Solution, 0.09% At Visits 3A and 4, a trained study technician will instill one drop of the assigned, masked study treatment, into each eye.
16168080|NCT01639846|Drug|Vehicle for RX-10045 arm|Vehicle of RX-10045 Ophthalmic Solution At Visits 3A and 4, a trained study technician will instill one drop of the assigned, masked study treatment, into each eye.
16168082|NCT01639833|Device|TachoSil®|Topical Hemostat
16168083|NCT01639820|Procedure|identification of sentinel nodes + full pelvic lymph-node dissection|identification of sentinel nodes + full pelvic lymph-node dissection
16168084|NCT01639820|Procedure|only identification of sentinel nodes (without pelvic lymph-node dissection)|only identification of sentinel nodes (without pelvic lymph-node dissection)
16168085|NCT01639807|Drug|Latanoprost|Latanoprost (0.005%) eye drops, once daily in the evening
16168086|NCT01639807|Procedure|SLT|Selective Laser Trabeculoplasty
16168087|NCT01639794|Drug|Vesitirim™ (Solifenacin)|Oral
16168088|NCT01639781|Dietary Supplement|Flavanol rich intervention|Flavanol intervention drinks contain (400 mg flavanols) flavanol rich drink 2 x 400 mg 2 times a day over 2 weeks
16168089|NCT01639781|Dietary Supplement|Flavanol free control|Calorically, micro- and macronutrient matched control drink free of flavanols flavanol free drink 2 times a day over 2 weeks
16168090|NCT01639768|Drug|SUBLIVAC FIX Birch|Comparison of different dosages to placebo
16168091|NCT01639755|Device|new texture shaped breast implants|breast implant surgery
16168092|NCT01639742|Device|New texture round breast implants|Breast implant surgery
16168093|NCT01639729|Drug|Treatment A: Sufentanil IV|Sufenta IV (50 mcg/mL) 15 mcg push over 1 minute (IV)
16168094|NCT01639729|Drug|Treatment B: Sufentanil NanoTab Sublingual|Single Sufentanil NanoTab 15 mcg given sublingually (SL)
16168095|NCT01639729|Drug|Treatment C: Sufentanil NanoTab Buccal|Treatment C: Single Sufentanil NanoTab 15 mcg given buccally (BU)
16168096|NCT01639729|Drug|Treatment D: Sufentanil NanoTab Oral|Single Sufentanil NanoTab 15 mcg swallowed (PO)
16168097|NCT01639703|Drug|Xenetix-CT perfusion imaging|Injection of 50 ml of Xenetix
16168098|NCT01639690|Genetic|Autologous CD34+ cells transduced with TNS9.3.55|Patients will receive Filgrastim followed by apheresis of peripheral blood stem cells. CD34+ cells will be purified and transduced ex vivo. Transduced cells will be frozen in several aliquots whenever possible while vector copy number determination and biosafety testing are performed. Patients will be treated in the outpatient and/or inpatient units, and receive intravenous busulfan (8mg/kg) as non-myeloablative conditioning. Patients will be administered 2-12 x 10^6 transduced CD34+ cells per kg in 1 or several infusions. A back-up of 2 x 10^6 untransduced CD34+ cells per kg will be preserved for every patient.
16168099|NCT01639677|Procedure|Laparoscopic gastric bypass|Laparoscopic gastric bypass surgery
16168100|NCT01639677|Procedure|Laparoscopic VBG|Laparoscopic vertical banded gastroplasty
16168101|NCT01639664|Device|High doses CPFA|High doses CPFA (coupled plasma-filtration adsorption) with AMPLYA™ (BELLCO ITALY): >0.20 L/kg/day of plasma treated in the first 3 days after randomization.
16168102|NCT01639651|Other|Posterior capsule stretching|Control group that will be submitted for an evaluation of shoulder range of motion (internal/external rotation)for both limbs, upper limb active movements to warm-up (five minutes), posterior capsule stretching (Cross-body stretch for 3 sets of 30 seconds) and revaluation immediately post-intervention and four weeks post-intervention.
16168103|NCT01639651|Other|Mobilization with movement|Mobilization group that will be submitted for an evaluation of shoulder range of motion (internal/external rotation) for both limbs, upper limb active movements to warm-up (five minutes), posterior capsule stretching (Cross-body stretch for 3 sets of 30 seconds) plus a mobilization with movement to improve internal rotation of the dominant shoulder (three sets of 10 repetitions)and revaluation immediately post-intervention and four weeks post-intervention.
16168104|NCT01639638|Drug|PROAPOPTOTIC PEPTIDE CIGB 300|CIGB 300,in INTRALESIONAL on day 3 of each 48 HOURS.
16168105|NCT01639625|Drug|CIGB300|CIGB300: 15 mg, 35 mg and 70 mg All groups will receive CIGB-300 for local application.
16168106|NCT01639612|Biological|ALD-451|ALD-451 iv
16168107|NCT01639599|Drug|Dexamethasone iv injection|Dexamethasone 5mg iv during anesthesia induction
16168108|NCT01639599|Drug|Dexamethasone, haloperidol|dexamethasone + haloperidol 1mg
16168109|NCT01639599|Drug|Dexamethasone, haloperidol|Active Comparator: dexamethasone + haloperidol 2mg
16168110|NCT01639586|Behavioral|respite platform|Impact of the respite platform patient care on health profit
16168111|NCT01639586|Behavioral|Day care|Impact of the day care on health profit of patient
16168112|NCT01639586|Behavioral|No access to a respite structure|Control group without access to a respite structure
16168113|NCT01639573|Drug|Campath|Pediatric patients with dcSSc are eligible for the clinical trial if they fulfill the inclusion and exclusion criteria of the trial. The inclusion and exclusion criteria are based upon those of the SCOT trial for adult dcSSc patients, which is the Phase 3 clinical trial in the United States comparing autologous HSCT to monthly high dose cyclophosphamide (CY) alone.
16168114|NCT01639560|Drug|Varenicline|1 mg of varenicline twice per day for 12 weeks and brief behavioral counseling
16168115|NCT01639560|Drug|Placebo|1 placebo tablet twice per day for 12 weeks and brief behavioral counseling
16168116|NCT01639547|Drug|Peginterferon alfa-2a plus Ribavirin|Peginterferon alfa-2a(pre-filled syringes 180 mcg/0.5 ml once a week) plus ribavirin(200 mg/Capsules, 1000~1200 mg daily in split doses (morning/evening)) for 36 or 48 weeks
16168117|NCT01639521|Drug|cisplatin|Given IV
16168118|NCT01639521|Drug|gemcitabine hydrochloride|Given IV
16168119|NCT01639521|Drug|methotrexate|Given IV
16168120|NCT01639521|Drug|vinblastine|Given IV
16168121|NCT01639521|Drug|doxorubicin hydrochloride|Given IV
16168122|NCT01639521|Biological|pegfilgrastim|Given SC
16168123|NCT01639521|Other|laboratory biomarker analysis|Correlative studies
16168124|NCT01639508|Drug|Cabozantinib|Patients will receive cabozantinib at an initial dose of 60 mg orally daily. The drug is taken continuously over a period of 28 days (4 weeks), which constitutes one treatment cycle. Dose modifications for drug toxicity are permitted as per a prescribed algorithm. During the Treatment Period subjects will receive cabozantinib until either disease progression, the occurrence of unacceptable drug-related toxicity or for other reason(s) for subject withdrawal.
16168125|NCT01639495|Device|THERMOCOOL® SMARTTOUCH™ Catheter|AF Ablation
16168126|NCT01639469|Behavioral|Structured exercise|Structured exercise includes stretching, strengthening, and balance exercises.
16168127|NCT01639469|Behavioral|Lifestyle exercise|Subjects will be taught lifestyle exercises and advised about mobility strategies
16169613|NCT01627626|Drug|saline|0.9% saline solution
16168128|NCT01639456|Biological|CD3-/CD19- natural killer cells|Infused on Day 0. The final CD3-/CD19- product must contain at least 20% NK cells based on previous studies using this cell product processing technique. The entire cell product will be administered except in cases where the T cell count exceeds the T cell infusion threshold. In such situations, the product volume will be adjusted to meet the lot release criteria.
16168129|NCT01639456|Biological|CD3-CD56+ natural killer cells|Infused on Day 0. The final CD3-/CD56+ product must contain at least 70% NK cells based on a previous study using this cell product processing technique. The entire cell product will be administered except in cases where the T cell count exceeds the T cell infusion threshold. In such situations, the product volume will be adjusted to meet the lot release criteria.
16168130|NCT01639456|Device|CliniMACS® CD3 and CD19 Reagent System|In combination used to simultaneously deplete CD3+ cells to remove T-lymphocytes and deplete CD19+ cells to remove B-lymphocytes (CD3-/CD19-). The entire cell product will be administered except in cases where the T cell count exceeds the T cell infusion threshold. In such situations, the product volume will be adjusted to meet the lot release criteria.
16168131|NCT01639456|Device|CliniMACS® CD56 Reagent System|CliniMACS® CD3 and CD19 Reagent System will be used in addition to CliniMACS® CD56 Reagent System to enrich CD56+ NK cells. The entire cell product will be administered except in cases where the T cell count exceeds the T cell infusion threshold. In such situations, the product volume will be adjusted to meet the lot release criteria.
16168132|NCT01639456|Drug|Cyclophosphamide|Infused intravenously 60 mg/kg x day -5
16168133|NCT01639456|Drug|Fludarabine|Fludarabine 25 mg/m2 x days -6 through -2
16168134|NCT01639456|Drug|Aldesleukin|IL-2 subcutaneously at 6 million units every other day for 6 doses - begin evening of the NK cell infusion.
16168135|NCT01639443|Other|Predictive no-show overbooking|"During intervention period, every Veteran scheduled for an endoscopy will be offered fast-track offer, which gives them a chance to get their endoscopy procedure done earlier than usual scheduling by overbooking their appointment in a predictive no-show slot."
16168136|NCT01639430|Other|rectal, tympanal and temporal artery thermometry|"Temperature measurement was done once in all patients included within the first hour of patients´presentation to the emergency department.
~Tympanal measurement was carried out by the use of infrared ear thermometry, temporal artery thermometry was done using infrared technology as well."
16168137|NCT01639404|Procedure|Umbilical Cord Blood Administration|The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression.
16168138|NCT01639404|Other|Active Rehabilitation|All subjects should participate in active rehabilitation. They will receive two physical and occupational therapy sessions per day. Post discharge, each participant should continue to receive rehabilitation therapy at least 3 days per week until the study completion.
16168139|NCT01639391|Procedure|skin biopsy|biopsy 5mm maximum on healthy skin under local anaesthesia.
16168140|NCT01639378|Procedure|Renal Denervation|Symplicity Catheter System
16168141|NCT01639352|Biological|SOM230|Patients will be given a starting of 60mg of SOM230 via injection, intramuscularly every 28 days.
16168142|NCT01639339|Biological|Placebo plus standard therapy|Placebo plus standard therapy
16168143|NCT01639339|Biological|Belimumab 10 mg/kg plus standard therapy|Belimumab 10 mg/kg plus standard therapy
16168144|NCT01639339|Drug|Standard therapy|"The standard therapies allowed in this study are:
~- High-dose steroids (for example, methylprednisolone) plus cyclophosphamide for induction therapy followed by azathioprine for maintenance therapy
~OR
~- High-dose steroids plus mycophenolate for induction therapy followed by mycophenolate for maintenance therapy"
16168145|NCT01639326|Drug|Irinotecan high doses|Irinotecan dose of 300 mg / m² in patients UGT1A1 * 1 / * 1 and 260 mg / m² in patients UGT1A1 * 1 / * 28 intravenous infusion over 90 minutes and folinic acid at a dose of 400 mg / m² intravenous infusion over 2 hours and 5-FU at a dose of 400 mg / m² intravenous bolus and 5-FU 2400 mg / m² intravenous infusion for 46 hours.
16168146|NCT01639326|Drug|Irinotecan standard doses|Irinotecan at a dose of 180 mg / m² intravenous infusion over 90 minutes and folinic acid at a dose of 400 mg / m intravenous infusion over 2 hours and 5-FU at a dose of 400 mg / m² intravenous bolus and 5-FU 2400 mg / m² intravenous infusion for 46 hours.
16168147|NCT01639300|Biological|GNbAC1|Single dose intravenous (IV) GNbAC1 2mg/kg or 6mg/kg
16168148|NCT01639300|Biological|GNbAC1 placebo|Single dose intravenous (IV) GNbAC1 placebo
16168149|NCT01639274|Other|COPD prevalence|Determine prevalence of COPD
16168150|NCT01639261|Drug|Interferon gamma 1b|Initial dose: 50µg s.c. three times/week, without fever >38,5 dose increase: 50µg/m² BSA three times/week
16168151|NCT01639248|Drug|ENMD-2076|250 mg per day in oral capsules in 28 day continuous cycles
16168152|NCT01639222|Drug|Calcium 500 mg and Vitamin D3 800 IU|Calcium 500 mg and Vitamin D3 800 IU chewable tablets
16168153|NCT01639222|Other|Low calcium meals|A normal Western European diet with reduced calcium content (400 mg per day).
16168154|NCT01639209|Procedure|Vitrectomy|Pars plana vitrectomy plus laser/cryotherapy
16168155|NCT01639209|Procedure|Pneumatic retinopexy|Pneumatic retinopexy plus laser/cryotherapy
16168156|NCT01639196|Other|Self-compassion writing|Participants are instructed to write about their chronic pain in a way that elicits self-compassion for 20 minutes once a week for three consecutive weeks.
16168157|NCT01639196|Other|Self-efficacy writing|Participants are instructed to write about their chronic pain in a way that elicits self-efficacy for 20 minutes once a week for three consecutive weeks.
16168158|NCT01639183|Device|Rotating-oscillating Power Toothbrush|A power toothbrush will be used twice daily for performing daily oral care on nursing home residents by their caregivers.
16168159|NCT01639183|Other|Standard Care|Standard daily oral hygiene care by caregivers of nursing home residents whatever that standard care may be.
16168160|NCT01639170|Radiation|chest radiograph|"All enrolled patients underwent erect chest x-rays assessment. In all cases the diagnosis of pneumoperitoneum was based upon the plain film identification of subdiaphragmatic air on the upright posteroanterior chest radiograph.
~All patients were transported from their hospital rooms to the radiology department in wheelchairs and remained in an upright position for more than 10 min before the chest radiographs were obtained. In all cases upright posteroanterior was obtained with the patient standing, using 183-cm distance, 125 kVp, phototimed exposure, and radiographic film with a wide exposure latitude.
~The disappearance of intraabdominal free gas will be evaluated every 48h and will be defined as the loss of the"
16168161|NCT01639157|Drug|Buspirone|Subjects will be maintained on oral buspirone (10 mg administered 3 times daily) for 6 days each during the study in random order.
16168162|NCT01639157|Drug|Placebo|Subjects will be maintained on oral placebo (0 mg administered 3 times daily) for 6 days each during the study in random order.
16168163|NCT01639144|Biological|PRP and PPP|Autogenous PRP and PPP
16168164|NCT01639131|Drug|Gemcitabine|intravenous gemcitabine 800mg/m2 on days 1 and 8
16168165|NCT01639131|Drug|Docetaxel|docetaxel 70mg/m2 on day 8 of each 21 day cycle
16168166|NCT01639131|Drug|Filgrastim or Pegfilgrastim|filgrastim (G-CSF) on days 9 through 15 or pegfilgrastim 6mg on day 9 or 10 of each cycle
16168167|NCT01639105|Procedure|Laser treatment|10 600 NM ABLATIEVE FRACTIONATED LASER
16168168|NCT01639092|Drug|Tenofovir|Tenofovir 300mg Daily Oral
16168169|NCT01639092|Drug|Tenofovir|Tenofovir 300mg Daily Oral
16168170|NCT01639092|Drug|Entecavir|Entecavir 1 mg daily Oral
16168171|NCT01639079|Behavioral|Internet Smoking Cessation Web Site|Internet Stop Smoking site (TC5) with several intervention elements from which the participants may choose as many as they wish. The links (URLs) to register for the study are: English: www.stopsmoking.ucsf.edu Spanish: https://www.stopsmoking.ucsf.edu/es/intro/home.aspx
16168172|NCT01639066|Drug|Tenofovir|Tenofovir 300mg daily Oral
16168173|NCT01639066|Drug|Entecavir|Entecavir 1 mg daily Oral
16168174|NCT01639066|Drug|Tenofovir|Tenofovir 300mg daily Oral
16168175|NCT01639040|Drug|Dupilumab|Dupilumab 300 mg once weekly (QW) for 4 weeks
16168176|NCT01639040|Drug|Placebo (for Dupilumab)|Placebo (for Dupilumab) once weekly (QW) for 4 weeks
16168177|NCT01639040|Other|Topical Corticosteroid (TCS)|TCS such as methylprednisolone aceponate 0.1%, mometasone furoate 0.1%, or betamethasone valerate 0.1%
16168178|NCT01639027|Drug|Drotaverine|40 mg Drotaverine hydrochloride (Do-Spa) IV injection at the start of the study and repeated every 2 hours up to a maximum 3 injections.
16168179|NCT01639027|Drug|Placebo|Women who will receive 2ml of normal physiological saline (0.9% sodium chloride) I.V at the start of the active phase of labor.
16168180|NCT01639014|Drug|F2695|75 mg OD in 2 capsules
16168181|NCT01639014|Drug|placebo|2 capsules
16168182|NCT01639001|Drug|Crizotinib|250 mg two times daily [BID], oral, on a continuous daily dosing schedule. Cycles are defined in 21 day periods.
16168183|NCT01639001|Drug|Pemetrexed/Cisplatin|Option 1: Pemetrexed/Cisplatin; Pemetrexed, 500 mg/m^2, will be administered by intravenous infusion over 10 minutes or according to institutional administration timing on Day 1 of a 21-day cycle. Cisplatin, 75 mg/m^2 will be administered by infusion after adequate hydration according to institutional practices beginning approximately 30 minutes after the end of the pemetrexed infusion. Pemetrexed and cisplatin will be repeated every 3 weeks for a maximum of 6 cycles.
16168184|NCT01639001|Drug|Pemetrexed/Carboplatin|Option 2: Pemetrexed/Carboplatin. Pemetrexed, 500 mg/m^2, will be administered by intravenous infusion over 10 minutes or according to institutional administration timing on Day 1 of a 21-day cycle. Carboplatin, at a dose calculated to produce an AUC of 5 or 6 mg.min/mL will be administered by infusion according to institutional practices beginning approximately 30 minutes after the end of the pemetrexed infusion. Pemetrexed and carboplatin will be repeated every 3 weeks for a maximum of 6 cycles.
16168185|NCT01638988|Drug|Metformin|"cycle 2000 mg of Metformin : Day 1 to day 30; beginning with 1/2 tablet by day with an increasing until 4 pills by day
~to 6 cycle 2000 mg of Metformin : Day 1 ot day 30; 4 pills of Metformin by day Positive pregnancy test : 4 pills of Metformin by day until 12 weeks of pregnancy"
16168186|NCT01638988|Drug|Clomiphene citrate|Cycle 1: Day 3 to day 7; 50 mg; 1 tablet of Clomiphene Citrate by day Cycle 2: Day 3 to day 7; 100 mg; 1 tablet of Clomiphene Citrate two times a day Cycle 3 to 6 : Day 3 to day 7; 150 mg; 1 tablet of Clomiphene Citrate 3 times a day
16168187|NCT01638975|Behavioral|Response Inhibition Training Program|This is a computerized cognitive retraining program consisting of 8 sessions delivered over a 4-week period.
16168188|NCT01638962|Drug|Instruction on analgesic use for pain relief (acetaminophen and NSAIDs)|The PHARMA group receives instruction, by video and pamphlet, on how to best use acetaminophen and NSAID as pain management for knee OA.
16168189|NCT01638962|Other|Neuromuscular exercise|The exercise group receives 1 hour of supervised neuromuscular exercise two times a week for 8 weeks. Supervision is conducted by physiotherapists specially trained in using neuromuscular exercise and its principles.
16168190|NCT01638949|Behavioral|Memory assessment|Neuropsycological tests including clinical and original tests to compare differences between each populations.
16168191|NCT01638949|Biological|Circulating biomarkers measure|ELISA tests from blood samples to compare differences between each populations.
16168192|NCT01638949|Genetic|ApoE4|Evaluation of apolipoprotein E polymorphism as a risk factor.
16168193|NCT01638949|Other|Brain imaging examination MRI and PET examinations|Structural and functional MRI FDG-PET to compare differences between each populations.
16168194|NCT01638936|Drug|BT062 , intravenous administration|Dose escalation to determine dose limiting toxicities (DLTs) and/or the maximum tolerated dose (MTD)/recommended Phase II dose (RPTD) of BT062 in combination with lenalidomide/dexamethasone
16168195|NCT01638923|Drug|EV/DNG (Qlaira, Natazia, BAY86-5027)|2 days of 3 mg estradiol valerate (EV);5 days of 2 mg EV + 2 mg dienogest (DNG);17 days of 2 mg EV + 3 mg DNG;2 days of 1 mg EV;2 days of placebo. A blister card consists of 28 pills, taken orally once a day for 7 cycles of 28 days each.
16168196|NCT01638923|Drug|placebo|Matching placebo to be taken orally daily for 7 cycles of 28 days each.
16168197|NCT01638910|Drug|EV/DNG (Qlaira, BAY86-5027)|Oral estradiol valerate and dienogest (2 days 3.0 mg estradiol valerate (EV), 5 days 2.0 mg EV + 2.0 mg dienogest (DNG), 17 days 2.0 mg EV + 3.0 mg DNG, 2 days 1.0 mg EV, 2 days placebo), one table oral daily for 13 treatment cycles (1 cycle = 28days)
16168198|NCT01638884|Behavioral|Memory assessment|Neuropsychological tests including clinical and original tests to compare differences between each populations
16168199|NCT01638884|Other|Structural MRI|to compare differences between each populations
16168200|NCT01638884|Other|Functional MRI|to compare differences between each populations
16168201|NCT01638884|Other|Virtual reality / Memory assessment|to compare differences between each populations
16168473|NCT01636817|Drug|placebo|Administered subcutaneously (s.c., under the skin) once weekly.
16323837|NCT00470366|Drug|paclitaxel|
16168202|NCT01638871|Behavioral|PainCOACH|The 8-week Internet-based pain coping skills intervention program includes 8 sessions. Each session takes 30-45 minutes to complete and includes text, illustrations, photos, animations, audio narration, interactivity, and delivery of personalized feedback. Users will be expected to complete 1 session per week.
16168203|NCT01638858|Drug|Lucentis (Ranibizumab)|Ranibizumab Short- and Log-term Effects on Retinal Function measured by Multifocal-ERG and Microperimetry
16168204|NCT01638845|Procedure|continuous perineural catheter|continuous perineural catheter
16168205|NCT01638832|Device|Transient Elastography (FibroScan), Echosens, Paris, France|
16168206|NCT01638832|Device|Controlled Attenuation Parameter (CAP), Echosens, Paris, France|
16168207|NCT01638819|Biological|Autologous Cord Blood Stem Cells|One infusion of 60 ml syringe of study product
16168208|NCT01638819|Biological|Placebo|Saline
16168209|NCT01638806|Procedure|Group I: Primary PCI|Patients are treated with Aspirin, ADP-blocker and heparin and field-triaged or transferred immediately to an invasive center for PPCI
16168210|NCT01638793|Device|Microcap (Oridion, Needham, MA, USA)|
16168211|NCT01638793|Device|Smart Capno Line Plus O2 (Oridion, Needham, MA, USA)|
16168212|NCT01638780|Dietary Supplement|placebo|A placebo will given for 30 days, twice daily. One pill will be provided with lunch, and the other pill will be provided with dinner.
16168213|NCT01638780|Dietary Supplement|resveratrol|resveratrol will be given for 30 days, twice daily. One pill, which contains 75 mg of resveratrol, will be provided with lunch, and the other pill, also containing 75 mg will be given with dinner. So in total a dose of 150 mg/day will be given.
16168214|NCT01638767|Drug|Contraceptives, Oral|0.150 mg desogestrel and 0.030 mg ethinyl estradiol tablets, USP. One tablet per day at the same time each day, from the beginning of the menstrual cycle.
16168215|NCT01638767|Drug|Contraceptive, Vaginal ring|etogestrel/ ethinyl estradiol slow release vaginal ring (11.4 mg/2.6 mg) to deliver 120 mcg etonogestrel/15 mcg ethinyl estradiol per day
16168216|NCT01638754|Procedure|Image guided Cardiac Resynchronization Therapy (CRT) device lead placement.|Participants will have a cardiac MRI scan prior to insertion of CRT device and an image guided map will be created to guide placement of Cardiac Resynchronization Therapy (CRT) pacing leads to the most optimal target on the patients heart.
16168217|NCT01638754|Procedure|optimizing myocardial lead placement for Cardiac Resynchronization Therapy (CRT) devices|optimal lead placement will be determined by 3D model of coronary vein anatomy, myocardial scar and mechanical dyssynchrony
16168218|NCT01638741|Behavioral|Rehabilitation goals of patients with gynaecological cancer.|Conversations with the nurse and supportive phone calls. Conversation are structured and placed 1 and 3 months after surgery. Phone calls are carried out at two and three months after surgery.
16168219|NCT01638715|Drug|Remicade|- Infliximab (Remicade®) will be administered i.v. at a dose of 3 mg/kg at 0 and 2 weeks, and 5 mg/kg at weeks 6, 14, and 22, 30, 38, and 46.
16168220|NCT01638715|Drug|Orencia|- Abatacept (Orencia®) will be given i.v. at weeks 0, 2, 4, and then every 4 weeks until week 48 at a weight adjusted dose: <60 kg Body weight (BW): 500 mg; >60-100 kg BW: 750 mg; alternatively, based on preference and shared decision between patient and physician, patients randomized to the abatacept arm may receive s.c. application at a dose of 125mg weekly.
16168221|NCT01638715|Drug|Ro-Actemra|- Tocilizumab (Ro-Actemra®) will be administered every 4 weeks at a dose of 8 mg/kg BW (maximum dose of 800 mg); The employed dosage will be calculated using manufacturer guidelines; alternatively, based on preference and shared decision between patient and physician, patients randomized to the tocilizumab arm may receive s.c. application at a dose of 162mg every week.
16168222|NCT01638715|Drug|Mabthera|"- Rituximab (Mabthera®) will be given as 1000mg at weeks 0 and 2, and then repeated at weeks 24 and 26.
~Patients will receive 100 mg methylprednisolon i.v. before each infusion, as well as 1000mg paracetamol, as well as 50mg diphenhydramine hydrochloride (Dibondrin©)."
16168223|NCT01638702|Other|Follow up of complications|Follow up for complications leading or not to removal (occlusion, accidental removal, infection, catheter related thrombosis, leaking, pain...)
16168224|NCT01638689|Drug|Escitalopram|20 mg p.o.
16168227|NCT01638663|Drug|Tolvaptan|15 mg pr day for 1 day
16168228|NCT01638663|Drug|Placebo|1 tablet Unikalk 1 pr day for 1 day
16168229|NCT01638650|Drug|Nucleoside Reverse Transcriptase Inhibitor (NRTIs)|in accordance with current clinical HIV treatment guidelines
16168230|NCT01638650|Drug|ritonavir|100 mg bid orally, Days 1-14
16168231|NCT01638650|Drug|saquinavir [Invirase]|500 mg bid orally Days 1-7, 1000 mg bid orally Days 8-14
16168232|NCT01638637|Device|APTIMA Assays; PANTHER System|APTIMA Assays; PANTHER System
16168233|NCT01638624|Drug|Propofol|Propofol :Propofol is an anesthetic agent, has structure similar to that of known such as alfa tocopherol.
16168234|NCT01638624|Drug|Placebo|
16168235|NCT01638611|Drug|HIP2B|Total daily doses of 60, 120, 240, 480, and 720 mg are planned in five separate dosing cohorts. Single or split dose (depending on dose volume) will be given by subcutaneous injection in the abdomen to six subjects per dosing cohort.
16168236|NCT01638611|Drug|Placebo|Equal volumes of placebo will be given by subcutaneous injection in the abdomen to 2 randomized subjects per dosing cohort.
16168237|NCT01638598|Drug|matching placebo|matching placebo in each dose level
16168238|NCT01638598|Drug|Test drug|BI 1021958
16168239|NCT01638598|Drug|matching placebo|matching placebo in each dose level
16168240|NCT01638598|Drug|Test drug|BI 1021958
16168241|NCT01638598|Drug|Test drug|BI 1021958
16168242|NCT01638598|Drug|Test drug|BI 1021958
16168243|NCT01638598|Drug|Test drug|BI 1021958
16168244|NCT01638598|Drug|matching placebo|matching placebo in each dose level
16168245|NCT01638598|Drug|matching placebo|matching placebo in each dose level
16168246|NCT01638598|Drug|matching placebo|matching placebo in each dose level
16168247|NCT01638585|Drug|urokinase|daily short infusions, i. e. i. v. application of 1.000.000 I.E. urokinase over 30 min. for at least 10 and up to 21 days during the 30 days after randomization
16324218|NCT00467662|Drug|Docosanol 10%|
16168248|NCT01638559|Drug|Immunosuppression withdrawal|Participants will undergo gradual ISW in no less than 36 weeks and no more than 52 weeks with frequent monitoring of liver tests. All participants will be followed for 48 months ensuring a minimum of 36 months of follow-up after successful ISW.
16168249|NCT01638546|Other|Laboratory Biomarker Analysis|Correlative studies
16168250|NCT01638546|Other|Placebo|Given PO
16168251|NCT01638546|Drug|Temozolomide|Given PO
16168252|NCT01638546|Drug|Veliparib|Given PO
16168253|NCT01638533|Other|Pharmacological Study|Correlative studies
16168254|NCT01638533|Drug|Romidepsin|Given IV
16168255|NCT01638520|Drug|Pascolizumab|0.05mg/kg - 10mg/kg Pascolizumab according to dosing cohort
16168256|NCT01638520|Drug|Placebo|Saline (volume determined based on weight of patient, and cohort of enrollment)
16168257|NCT01638507|Device|Resolute Integrity Stent|Medtronic Resolute Integrity Zotarolimus-Eluting Coronary Stent System
16168258|NCT01638494|Dietary Supplement|Colecalcium supplement|Daily Ca2+ and VitD intake was determined using a previously validated written dietary questionnaire, filled by the parents with the help of a registered dietitian. Eventual assumption of Ca2+ and/or VitD supplements or fortified foods was also registered. All questionnaires were collected and analyzed using a specific software based on the Italian food composition tables (Winfood, Medimatica SRL, Martinsicuro, Teramo, Italy). All data were recorded in a specific clinical chart before statistical analysis. All subjects with less than 70% of the DRIs were invited to participate in a randomized trial aiming to investigate the efficacy of different nutritional interventions. The dietitian gave information to the parents on how to improve the consumption of foods rich in Ca2+ and VitD according to DRIs. No nutritional support products were prescribed in children enrolled in group 2.
16168259|NCT01638468|Device|AngioJet Ultra PE Thrombectomy System|Thrombectomy with or without lytic delivery using the AngioJet Ultra PE Thrombectomy System
16168260|NCT01638455|Device|Noninvasive device|Noninvasive device
16168261|NCT01638442|Drug|CHR-2797|Two 60 mg capsules (120 mg dose) of CHR-2797 administered orally with 240 mL room temperature tap water after an approximately 10 hour fast.
16168262|NCT01638442|Drug|CHR-2797|"Two 60 mg capsules (120 mg dose) of CHR-2792 administered orally with 240 mL room temperature tap water within 30 minutes of receiving a high-fat meal.
~--------------------------------------------------------------------------------"
16168263|NCT01638429|Drug|Neomycin|Neomycin: 500mg po bid for 10 days
16168264|NCT01638429|Drug|Rifaximin|Rifaximin: 550mg po tid for 10 days
16168265|NCT01638416|Other|Blood transfusion|Blood transfusion in ICU patients aged 18 and over.
16168266|NCT01638403|Drug|BF2.649|"BF2.649 is provided in capsules. One-quarter or one-half of BF2.649 tablet at 20 mg (corresponding to 5-, and 10 mg, respectively).
~Patients should take 2 capsules per day with a glass of water. They will be instructed to take 1 capsule in the morning (after waking up, before breakfast around 8.00 a.m.) and 1 capsule at noon."
16168267|NCT01638403|Drug|Vigil|"Modafinil is provided in capsules. The capsules are identical in appearance to ensure that neither the patient nor the investigator nor members of the clinical staff knows the identity of the study medication.
~Modafinil tablet at 100 mg are enclosed in gelatine capsules. Patients should take 2 capsules per day with a glass of water. They will be instructed to take 1 capsule in the morning (after waking up, before breakfast around 8.00 a.m.) and 1 capsule at noon."
16168268|NCT01638403|Drug|palcebo|"placebo is provided in capsules. The capsules are identical in appearance to ensure that neither the patient nor the investigator nor members of the clinical staff knows the identity of the study medication.
~placebo consist of identical capsules containing lactose only. Patients should take 2 capsules per day with a glass of water. They will be instructed to take 1 capsule in the morning (after waking up, before breakfast around 8.00 a.m.) and 1 capsule at noon."
16168269|NCT01638390|Device|Treatment with the VisuMax™ Femtosecond Laser|The reduction or elimination of myopia from ≥ -1.00 D to ≤ -8.00 D with ≤ -0.50 D cylinder and MRSE ≤ -8.25 D.
16168270|NCT01638377|Drug|Naltrexone|50 mg/day for 24 weeks. All participants will receive medical intervention in the form of medical management (MM) which will be delivered by a trained health care professional.
16168271|NCT01638377|Drug|Control|Placebo (Lactose Monohydrate) for 24 weeks. All participants will receive medical intervention in the form of medical management (MM) which will be delivered by a trained health care professional.
16168272|NCT01638364|Drug|alcoholic beverage|An appropriate amount of 95% USP ethyl alcohol will be mixed in orange juice and tonic water to obtain a drink equivalent to 3-5 standard drinks. The beverage will be consumed over a period of 15 minutes.
16168273|NCT01638364|Drug|non-alcoholic beverage|This beverage will be a mixture of orange juice and tonic water. The beverage will be consumed over a period of 15 minutes.
16168274|NCT01638351|Behavioral|Resistance exercise|Progressive resistance exercise training, 3 times a week for 12 weeks.
16168275|NCT01638351|Behavioral|Usual care|Participants in this arm will receive a brochure specific for type 2 diabetes mellitus about the general principles of exercise, nutrition, and diet. They are asked to maintain their activity level.
16168276|NCT01638338|Behavioral|Web assisted brief motivational interview on risky drinking|People allocated to this arm will be given a password to enter and follow a pre-decided set of questions and hints to reduce their drinking
16168277|NCT01638338|Behavioral|Face to Face|The counseling provided by the GPs will be done at month 0, 6, 12
16168278|NCT01638325|Drug|Insulin Lispro|Administered SC
16168279|NCT01638325|Drug|BC106 insulin lispro|Administered SC
16168280|NCT01638299|Device|Hypo-Hyper Minimizer (HHM) System|Adjustment of Insulin dosing during meal time
16168281|NCT01638273|Drug|Pregabalin 150mg|GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, after meal) for three days
16168282|NCT01638273|Drug|Pregabalin 75mg|Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day, after meal) for three days
16168283|NCT01638260|Drug|Liraglutide|Liraglutide once daily 1.8 mg injection subcutaneously, 26 weeks
16168284|NCT01638260|Behavioral|NEAT|Increasing NEAT by activating lifestyle interventions, combined with liraglutide once daily 1.8mg injections subcutaneously
16168285|NCT01638247|Drug|Tamoxifen|25 mg daily.
16168286|NCT01638247|Drug|Tamoxifen and GnRH analogue|"25 mg Tamoxifen daily and GnRH analogue:
~Goserelin (10.8 mg s.c. after randomisation and after three months) or
~Leuprorelin (11.25 mg s.c. after randomisation and after three months)."
16324219|NCT00467662|Device|Superlysine gel|
16168287|NCT01638247|Drug|Exemestane and GnRH analogue|"25 mg Exemestane daily and GnRH analogue:
~Goserelin (10.8 mg s.c. after randomisation and after three months) or
~Leuprorelin (11.25 mg s.c. after randomisation and after three months)."
16168288|NCT01638234|Dietary Supplement|Melatonin|melatonin 3 mg tab 1 tab po hs for 4 weeks
16168289|NCT01638234|Dietary Supplement|Placebo|starch pill
16168290|NCT01638208|Drug|VSL#3|Dosage Form: Capsules (Details as given below); Dose and duration of treatment: 1 capsule b.i.d for 8 weeks; Each capsule contains 112.5 Billion CFU of the following 8 strains of bacteria, 4 lactobacilli strains (L. acidophilus, L. plantarum, L. paracasei, L. delbrueckii subsp bulgaricus), 3 bifidobacteria strains (B. breve, B. infantis, B. longum) and 1 strain of S. thermophilus).
16168291|NCT01638195|Device|Focused Ultrasound|Focused Ultrasound
16168292|NCT01638182|Dietary Supplement|Placebo|27 participants received for three months 1 placebo capsule per day
16168293|NCT01638182|Dietary Supplement|Vitamin K1-capsules|27 participants received for 3 months 1 vitamin K1-capsule per day containing 52 µg of K1/day
16168294|NCT01638182|Dietary Supplement|Vitamin K2-capsules|27 participants received for 3 months 1 vitamin K2-capsule per day containing 75 µg of MK-7.
16168295|NCT01638169|Device|adding a heel|walking with and without heels on the gaitrite system
16168296|NCT01638143|Dietary Supplement|MenaQ7 M-1500 capsules|"The study participants will receive three different types of capsules as a single dose (75 μg of MK-7/day):
~MenaQ7 M-1500 capsule
~Gnosis P-1000 capsule
~Gnosis M-1500 capsule
~Every two weeks, participants switch to another type of capsule; the washout period will therefore be two weeks."
16168297|NCT01638143|Dietary Supplement|Gnosis P-1000 capsules|"The study participants will receive three different types of capsules as a single dose (75 μg of MK-7/day):
~MenaQ7 M-1500 capsule
~Gnosis P-1000 capsule
~Gnosis M-1500 capsule Every two weeks, participants switch to another type of capsule; the washout period will therefore be two weeks."
16168298|NCT01638143|Dietary Supplement|Gnosis M-1500 capsules|"The study participants will receive three different types of capsules as a single dose (75 μg of MK-7/day):
~MenaQ7 M-1500 capsule
~Gnosis P-1000 capsule
~Gnosis M-1500 capsule
~Every two weeks, participants switch to another type of capsule; the washout period will therefore be two weeks."
16168299|NCT01638117|Other|PAC14028-Vehicle|PAC-14028 Cream Vehicle, Daily for up to 21 days
16168300|NCT01638117|Drug|PAC14028-0.1|PAC-14028 Cream, 0.1%, Daily for up to 21 days
16168301|NCT01638117|Drug|PAC14028-0.3|PAC-14028 Cream, 0.3%, Daily for up to 21 days
16168302|NCT01638117|Drug|PAC14028-1.0|PAC-14028 Cream, 1%, Daily for up to 21 days
16168303|NCT01638117|Other|Saline|Saline, Daily for up to 21 days
16168304|NCT01638117|Other|Positive|Sodium Lauryl Sulfate, 0.5%, Daily for up to 21 days
16168305|NCT01638104|Drug|ANX-042|Reconstituted in Sterile Water for Injection, United States Pharmacopeia (USP) and administered by 12 hour continuous intravenous infusion with 5% dextrose in water (D5W), United States Pharmacopeia (USP)
16168306|NCT01638104|Drug|Placebo|Administered once by 12 hour continuous intravenous infusion with D5W (USP)
16168307|NCT01638091|Behavioral|Ex vivo module|Pre-test, ex vivo computerized training module, post-test
16168308|NCT01638091|Behavioral|In vivo practice-base learning phase|Prediction of polyp histology in real time, comparison to pathology reports, and review of cumulative individual performance.
16168309|NCT01638078|Drug|Thalidomide|Thalidomide, pill, 50 mg, once p.d., 6 weeks
16168310|NCT01638078|Drug|Placebo|Placebo, pill, once p.d., 6 weeks
16168311|NCT01638052|Drug|0.25% Bupivacaine + Clonidine|Patients will receive 2mL of 0.25% bupivacaine with 2mcg/ml of clonidine
16168312|NCT01638039|Other|Laboratory Tests|Stool, blood, urine and saliva samples
16168313|NCT01638026|Drug|TRIPTORELIN ACETATE, hCG|In the study group women will receive GnRH agonist (decapeptyl 0.2 mg) for oocyte maturation, followed by ovum pick-up which will be performed 35 hours later. Embryo transfer will be performed 48-72 hours after ovum pick-up. Luteal support will include HCG 1500 IU.
16168314|NCT01638013|Drug|Peficitinib|Oral Tablet
16168315|NCT01638000|Drug|Mirabegron|oral tablet
16168316|NCT01638000|Drug|Solifenacin succinate|oral tablet
16168317|NCT01637987|Procedure|Unassisted vein visualization|The traditional technique of vein visualization and palpation will be used to identify veins during the PIV insertion procedures. This involves the use of a tourniquet to facilitate venous pooling to see the vein and prevent vein rupture during cannulation. Nurse may use heat application to facilitate vein identification.
16168318|NCT01637987|Procedure|Wee Sight® Transilluminator|The Wee Sight® Transilluminator (Philips Children's Medical Ventures, Monroeville, PA) is a hand held, non-heat producing, light emitting diode (Class 2), battery operated device. The device is held adjacent to or under the subject's extremity to visualize the venous anatomy superficial veins absorb light and appear as dark lines against the surrounding illuminated tissues. Vein visualization improves with dimmed room lighting and a thin subcutaneous tissue layer. Nurse will assess vascular anatomy using traditional techniques of visualization and palpation with tourniquet/heat application as needed, and add the Wee Sight to assist in vein identification.
16168319|NCT01637987|Procedure|VeinViewer® (Christie Digital Systems, Cypress, CA)|VeinViewer near infrared light views hemoglobin up to 10 mm beneath skin. Hemoglobin absorbs the light while surrounding tissue scatters it providing a suitable contrast between the vein & surrounding subcutaneous tissue. This data is captured, digitally processed by video camera, and projected back onto the skin as a visual image of venous anatomy. Nurse will assess vascular anatomy using traditional techniques of visualization and palpation with tourniquet/heat application as needed, and add the VeinViewer to assist in vein identification.
16168320|NCT01637974|Drug|INTERCOAT administration|Applying INTERCOAT in the intrauterine cavity at the end of the hysteroscopic surgery
16168321|NCT01637961|Drug|Alisertib|Given PO
16168322|NCT01637961|Other|Laboratory Biomarker Analysis|Correlative studies
16168323|NCT01637948|Drug|Listerine mouthrinse|For six months
16168324|NCT01637948|Drug|Chinese Medicine mouthrinse|six months
16168325|NCT01637935|Drug|Pioglitazone|Pioglitazone tablets.
16168326|NCT01637922|Drug|BI 201335|BI 201335 for 9 days
16168327|NCT01637922|Drug|BI 201335|BI 201335 for 9 days
16168474|NCT01636804|Device|Quicksite|St. Jude Medical produced lead called Quicksite
16168475|NCT01636804|Device|Quickflex|St. Jude Medical produced lead called Quickflex
16324541|NCT00464880|Drug|Aliskiren|
16168328|NCT01637909|Drug|Control group who are advised for proper life style modification by the physician such as regular exercise and healthy diet without active intervention.|All the study subjects will undergo baseline brachial blood pressure measurement(OMRON HEM 7080IT), central aortic blood pressure measurement with Sphygmocor device(AtCor Medical), baseline laboratory, 24hr urine Na measurement, 24 hour ambulatory blood pressure and cardiopulmonary exercise test. These tests will be repeated at the 8th week.
16168329|NCT01637909|Dietary Supplement|Treatment group 1(Dietary intervention)|The dietary intervention is based on active education of the enrolled subjects based on Korean modified DASH diet. The enrolled subjects are advised to substitute processed white rice with whole grains such as barley. For protein, the subjects are advised to consume chicken and fish instead of red meat. Also, consumption of nuts are recommended where as processed foods containing high fructose corn syrup are not recommended. We will recommend to reduce salt intake by advising the subjects from adding table salts to their meals as well as adding salt during cooking. We will advise the subjects from eating pickles and condiments, which are the main source of salt in the Korean population. The degree of salt reduction before and after intervention will be assessed by 24 hour recall as well as measurement of 24 hour urine Na collection at baseline and at the 8th week. The compliance of the subjects will be assessed by 24hr recall as well.
16168330|NCT01637909|Other|Treatment group 2(dietary and exercise intervention)|The dietary intervention will be combined with exercise intervention. At baseline, the subjects will undergo evaluation for (1) cardiopulmonary function by undergoing cardiopulmonary exercise test and 3 minute step test 2) muscle strength assessment by hand grip test and 3) push ups to assess muscle endurance. After the initial evaluation, the subjects will be subjected to a course in aerobic exercise and muscle strengthening exercise developed by the Yonsei University Physical education department and will receive an educational DVD program. The subjects will each be given an electronic step counter to assess the degree of exercise. All the subjects in the treatment group 2 will be advised to undergo moderate to stenuous aerobic exercise for least 150 minutes /per week. Also, the subjects will be educated to perform muscle strengthening exercise as specificed in the educational program. The subjects will be asked to submit an exercise diary to assess the degree of compliance.
16168331|NCT01637896|Device|DEB+BMS|drug-eluting balloon predilation and bare metal stent implantation
16168332|NCT01637896|Device|POBA+DES|conventional balloon predilation and drug-eluting stent implantation
16168333|NCT01637883|Drug|benzydamine HCl|3 ml (4.5 mg) of benzydamine hydrochloride will be dripped on the cuff of the endotracheal tube 5 minutes prior to induction of general anesthesia
16168334|NCT01637870|Device|Prevena negative pressure wound system|Placement of negative pressure wound system at the time of cesarean delivery for those at increased risk for wound complication
16168335|NCT01637857|Dietary Supplement|sham oligoantigenic diet associated to lifestyle instruction|sham oligoantigenic diet associated to lifestyle instruction
16168336|NCT01637857|Dietary Supplement|oligoantigenic diet|oligoantigenic diet associated to life style counseling
16168337|NCT01637844|Drug|Telbivudine|HBsAg- and HBeAg-positive pregnant women at 28-32 weeks of gestation are given with telbivudine (oral 600 mg/day) until 4 weeks after delivery. Newborn infants are administered 100-200 IU HBIG within 12 hours after birth and vaccinated against hepatitis B with yeast recombinant hepatitis B vaccine (10 µg) at 0, 1, and 6-month schedule. HBV DNA and ALT levels are measured before the use of telbivudine, at delivery, and 1-2 months after stopping the drug. HBV serological markers, including HBsAg, anti-HBs, and anti-HBc, HBeAg and anti-HBe are tested in infants at age of 7-12 months.
16168338|NCT01637831|Procedure|Continuous Positive Airway Pressure (CPAP)|Continuous positive airway pressure (CPAP) is the gold standard for Obstructive Sleep Apnea (OSA) management. Subjects with OSA will be trained in the use of CPAP and will be instructed to use CPAP every night for 6 months. These subjects will then return for a post-treatment completion of questionnaires assessing sleep and quality of life 1, 3 and 6 months after the start of effective CPAP treatment.
16168339|NCT01637818|Procedure|Lichtenstein's operation|
16168340|NCT01637818|Procedure|Mesh Plug Repair|
16168341|NCT01637818|Drug|Opiate|Postoperative pain therapy
16168342|NCT01637818|Drug|Paracetamol|Postoperative pain therapy
16168343|NCT01637818|Drug|non-steroidal anti-inflammatory drug|Postoperative pain therapy
16168344|NCT01637805|Biological|Antigen-specific cytotoxic T lymphocytes induced by dendritic cells infected by recombinant adeno-associated virus with CEA gene|AAV-DC-CTL: Intravenous infusion, 1×109 cells, day 14; one cycle every month; at least one cycle
16168345|NCT01637792|Other|Three 2-liter exchanges daily CAPD|CAPD regimen of three 2-liter daily exchanges
16168346|NCT01637792|Other|Four 2-liter exchanges daily CAPD|CAPD regimen of four 2-liter daily exchagnes
16168347|NCT01637779|Behavioral|Fact sheet|fact sheet about pain management during immunization
16168348|NCT01637766|Drug|Melphalan (intra-arterial infusion)|"Patients will undergo a minimally invasive procedure called spinal angiography. This procedure will identify the arteries feeding the tumor causing cord compression and will determine whether chemotherapy can be safely infused.
~The chemotherapy will be infused via a tiny soft plastic tube (called microcatheter) at the tumor site over approximately 30 minutes.
~The drug of choice is melphalan (trade name Alkeran) at a maximum dose of 16mg/m2, adjusted for white cell count, platelet count and renal function.
~We will perform up to three intra-arterial chemotherapy treatments in 3-6 week intervals, based on the results of complete blood counts."
16168349|NCT01637753|Drug|Carmustine(BCNU)|Carmustine Sustained Release Implant
16168350|NCT01637753|Procedure|Surgery|Routine tumor resection surgery
16168351|NCT01637714|Drug|Multi-strain probiotics|"B. longum BORI: 1 x 109
~B. bifidum BGN4: 1 x 109
~B. lactis AD011: 1 x 109
~B. infantis IBS007: 1 x 109
~Lactobacillus acidophilus AD031: 1 x 109
~three times a day, within 10 minutes after meal, per oral with water"
16168352|NCT01637714|Drug|Placebo powder|"same taste, shape, dosage as experimental drug
~three times a day, within 10 minutes after meal, per oral with water"
16168353|NCT01637701|Procedure|PkEP|Plasmakinetic enucleation of the prostate
16168354|NCT01637701|Procedure|B-TURP|Bipolar transurethral resection of the prostate
16168355|NCT01637688|Dietary Supplement|Comparison of treatment with different amino acid formulas|Growth and amino acid status of a newly innovated amino acid formula (NAAF) and a commercial amino acid formula (AAF)
16168356|NCT01637675|Drug|20 mg sildenafil citrate by mouth|20 mg sildenafil citrate tablets by mouth three times a day for 8 weeks
16168357|NCT01637675|Drug|sodium tanshinone IIA sulfonate diluted with 5% glucose solution,20mg sildenafil citrate by mouth|sodium Tanshinone IIA sulfonate injection 80 mg diluted with 5% glucose solution(0.9% sodium chloride injection will also be permitted if necessary) 250ml iv drip once a day for 8 weeks,as well as 20mg sildenafil citrate tablets by mouth three times a day for the same duration of treatment
16168358|NCT01637662|Drug|Natriuretic peptides|I.V. infusion between 0.2-3 microgram over 20 minutes
16168359|NCT01637636|Drug|tasimelteon|20mg, oral capsule, once, Days 1 and 12
16168360|NCT01637636|Drug|tasimelteon|20mg, oral capsule, once, Days 1 and 6
16168361|NCT01637636|Drug|Rifampin|600mg, oral capsules (2 x 300mg), once daily (QD), Days 2-11
16168362|NCT01637636|Drug|Ketoconazole|400mg, oral tablets (2 x 200mg), once daily (QD), Days 2-6
16168363|NCT01637623|Drug|Losartan|Losartan 50 mg daily for two weeks, then increased to 100mg daily for 4 weeks if asymptomatic. Remain at 50 mg daily for 4 more weeks or removed from study if symptomatic.
16168364|NCT01637623|Drug|Allopurinol|Allopurinol 300 mg daily for 6 weeks
16168365|NCT01637623|Drug|Placebo|Placebo capsule daily for 6 weeks
16168366|NCT01637584|Drug|Prazosin|The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking.
16168367|NCT01637584|Drug|Placebo|The medication will be administered in the same manner, regardless of active or placebo, as the study physician and investigators, as well as the participants, will be blind to the type of medication they are taking.
16168368|NCT01637571|Drug|Dexilant|60mg of Dexilant QD for 12 weeks
16168369|NCT01637571|Drug|Dexilant Placebo|60mg of Dexilant placebo QD for 12 weeks
16168370|NCT01637558|Drug|8 hourly LPV/r during TB treatment|8 hourly LPV/r during TB treatment
16168371|NCT01637558|Drug|Nevirapine|
16168372|NCT01637558|Drug|Lopinavir/Ritonavir|
16168373|NCT01637545|Drug|Ramosetron|"G1 - Ramosetron 0.3mg i.v. just before the beginning of the surgery G2 - Ramosetron 0.3mg i.v. just after the end of the surgery and moving into the Recovery room
~G3 - No medication but regular antiemetics injection if the patient want"
16168374|NCT01637532|Drug|tocilizumab and interferon alpha 2-b|"During first three chemotherapy cycles, tocilizumab and/or Peg-Intron are added.
~Tocilizumab is given in a dose-escalation scheme (1,2,4,8mg/kg n=3) and Peg-Intron is adminstered subcutaneously 1.0ug/kg"
16168375|NCT01637532|Drug|Carboplatin and Caelyx or doxorubicin|Standard chemotherapeutic care given in every arm as standard care. A total of 6 cycles is the aim.
16168376|NCT01637493|Drug|Pegfilgrastim|Single SC injection of the appropriate dose of drug ranging from 30 mcg/kg to 200 mcg/kg at postchemotherapy 48hr in cycle 2, followed by two doses SC injection of the appropriate dose of drug ranging from 15 mcg/kg to 100 mcg/kg at postchemotherapy 48hr in cycle 3.
16168377|NCT01637493|Drug|Pegfilgrastim|Single SC injection of the appropriate dose of drug ranging from 30 mcg/kg to 200 mcg/kg at postchemotherapy 48hr in cycle 2, followed by two doses SC injection of the appropriate dose of drug ranging from 15 mcg/kg to 100 mcg/kg at postchemotherapy 48hr in cycle 3.
16168378|NCT01637493|Drug|Pegfilgrastim|Single SC injection of the appropriate dose of drug ranging from 30 mcg/kg to 200 mcg/kg at postchemotherapy 48hr in cycle 2, followed by two doses SC injection of the appropriate dose of drug ranging from 15 mcg/kg to 100 mcg/kg at postchemotherapy 48hr in cycle 3.
16168379|NCT01637493|Drug|Pegfilgrastim|Single SC injection of the appropriate dose of drug ranging from 30 mcg/kg to 200 mcg/kg at postchemotherapy 48hr in cycle 2, followed by two doses SC injection of the appropriate dose of drug ranging from 15 mcg/kg to 100 mcg/kg at postchemotherapy 48hr in cycle 3.
16168380|NCT01637480|Other|Lumbopelvic manipulation|High-velocity-low-amplitude thrust manipulation of the lumbopelvic region
16168381|NCT01637467|Other|Electrical muscle stimulation (EMS)|EMS delivered to the quadriceps and gluteal muscles, twice daily, 30 minutes per session for up to 4 weeks.
16168382|NCT01637467|Other|Sham EMS|Sham EMS delivered to the quadriceps and gluteal muscles, twice daily, 30 minutes per session for up to 4 weeks.
16168383|NCT01637454|Drug|Noradrenaline|Patients in group B received a continuous infusion of noradrenaline at an initial dose of 0.5 mg/hour, designed to achieve an increase in mean arterial pressure (MAP) of at least 10mmHg or an increase in 4-h urine output to more than 200 mL. When one of these goals was not achieved, the noradrenaline dose increased every 4 hour in steps of 0.5 mg/hour, up to the maximum dose of 3 mg/hour
16168384|NCT01637454|Drug|Terlipressin|Patients in group A received terlipressin as an intravenous bolus of 0.5 mg every 6 h. If a significant reduction in serum creatinine level (≥1 mg/dL) was not observed during 3-day period, the dose of terlipressin was increased in a stepwise fashion every 3 days to a maximum of 2 mg every 6 hour
16168385|NCT01637441|Procedure|laparoscopic sacropexy|under laparoscopic vision, the vesico-vaginal space is dissected until the level of the bladder neck. a synthetic non absorbable mesh is placed between the bladder and the vagina. the mesh is sutured to the vagina and the apex (vaginal apex or uterus) and anchored to the prevertebral ligament in front of the promontorium.
16168386|NCT01637441|Procedure|vaginal mesh|after anterior sagittal colpotomy, the bladder is dissected under the fascia layer, and the paravesical fossa are entered. a synthetic non absorbable mesh is placed with 4 arms suspension (trans obturator or not). treatment of the apex is mandatory.
16168387|NCT01637428|Device|ActiveCare+S.F.T 3rd generation|Intermittent Pneumatic Compression Device
16168388|NCT01637402|Drug|Abiraterone Acetate|"Standard dose participants:
~1,000 mg, once daily, oral administration.
~Dose escalation participants:
~1,000 mg, twice daily, oral administration"
16168389|NCT01637402|Drug|Prednisone|5 mg, twice daily, oral administration
16168390|NCT01637389|Other|Basic Safe Water Program|The intervention is community promotional meetings followed by household installations of a UV-based drinking water disinfection system (Mesita Azul). Households can opt-in at the meetings, or when the organization returns for installations in that community (~2 weeks later). Mesita Azul utilizes a 15-watt UV lamp to disinfect water and a closed mouth collection container for safe storage. The system utlizes UV-Tube technology developed as a method to disinfect water in low- and middle-income communities. The Basic Safe Water Program receives: the community meeting; installation of a Mesita Azul; a six month technical guarantee; one safe-storage container; training of one household member in operation and basic maintenance of the technology; training of at least one local resident in repair and system maintenance; and follow up after four to six months of the installation date.
16168391|NCT01637389|Other|Enhanced Safe Water Program|The intervention is community promotional meetings followed by household installations of a UV-based drinking water disinfection system (Mesita Azul). Households can opt-in at the meetings, or when the organization returns for installations in that community (~2 weeks later). Mesita Azul utilizes a 15-watt UV lamp to disinfect water and a closed mouth collection container for safe storage. The system utlizes UV-Tube technology developed as a method to disinfect water in low- and middle-income communities. The Enhanced program complements the Basic version with: a water quality analysis and presentation of results to households at the community meeting; a six-month money back guarantee; the provision of two safe-storage containers to facilitate access to disinfected water at different locations within the household; training of two household members in operation and basic maintenance of the technology; an additional follow up visit about two weeks after the installation date.
16168392|NCT01637376|Drug|Temoporfin|A single dose of 0.04 mg per kilogram of body weight of Temoporfin will be administered by slow intravenous injection into a deep vein (such as the antecubital vein) in not less than 6 minutes and will not be flushed with sodium chloride or any other aqueous solution.
16168393|NCT01637363|Behavioral|Psychoeducation|6 x 2 hours of psychoeducation
16168394|NCT01637350|Procedure|digestive tract reconstruction|Subtotal gastrectomy with BillrothⅠ or BillrothⅡ, total gastrectomy with jejunal interposition or Roux-en-Y reconstruction
16168395|NCT01637337|Procedure|laparoscopic pyelolithotomy|laparoscopy
16168396|NCT01637337|Procedure|percutaneous nephrolithotomy|percutaneous nephrolithotomy
16168397|NCT01637311|Procedure|POEM|Peroral endoscopic myotomy (POEM) has recently been described as a new minimally invasive endoscopic myotomy technique intending a permanent cure from primary achalasia.
16168398|NCT01637285|Biological|PF-04856883|Dose A
16168399|NCT01637285|Biological|PF-04856883|Dose B
16168400|NCT01637285|Biological|PF-04856883|Dose C
16168401|NCT01637285|Biological|PF-04856883|Dose D
16168402|NCT01637272|Drug|SOM230|Pasireotide (SOM230) sc injection was provided as solution for injection in individual 1-point-cut 1 mL ampule, containing nominally 200 μg of pasireotide (as free base). Doses: 50, 100, 150 and 200 μg. Pasireotide im LAR depot injection was provided as micro particles powder in vials containing nominally 10, 20, 40 & 60 mg of pasireotide (as free base) & solvent for suspension for injection in ampules for the reconstitution of the LAR micro particles. Doses: 10, 20, 30, 40 or 60 mg
16168403|NCT01637259|Drug|arm 1 nucleotide analogue reverse transcriptase inhibitors and boosted protease inhibitors|NRTI + PI
16168404|NCT01637259|Drug|Arm 2 boosted protease inhibitors and maraviroc|PI + maraviroc
16168405|NCT01637259|Drug|Arm 3 nucleotide analogue reverse transcriptase inhibitors and maraviroc|NRTI + maraviroc
16168406|NCT01637246|Drug|Any Fixed Combination Therapy|Patients with POAG or OHT previously treated with monotherapy and currently treated with any fixed combination therapy. This was a retrospective chart review study, so no treatment was administered in this study.
16168407|NCT01637233|Drug|Arm 1 TNucleotide Analogue Reverse Transcriptase Inhibitors and Boosted Protease Inhibitors|NRTI+PI
16168408|NCT01637233|Drug|Arm 2 Maraviroc and Protease Inhibitors|maraviroc + PI
16168409|NCT01637233|Drug|Arm 3 Maraviroc and Nucleotide Analogue Reverse Transcriptase Inhibitors|maraviroc + NRTI
16168410|NCT01637220|Biological|Blood volume collected specifically for this study|"case patient: 10 ml after the anaphylactic reaction, and during the Allergology-Anesthesia consult 6 to 8 weeks after the shock le choc.
~Control patients: 20 ml following neuromuscular blocking drug injection"
16168411|NCT01637207|Other|Palpation|Group A: Palpation Group
16168412|NCT01637207|Other|Ultrasound|Group B: Ultrasound Group
16168413|NCT01637194|Drug|everolimus|Given PO
16168414|NCT01637194|Biological|cetuximab|Given IV
16168415|NCT01637194|Other|pharmacological study|Correlative studies
16168416|NCT01637194|Other|laboratory biomarker analysis|Correlative studies
16168417|NCT01637181|Procedure|Endovenous laser ablation (EVLA)|EVLA with 940 nm Diode laser EVLA with 1470 nm Nd:Yag laser With both devices, obliteration of the varicose vein is obtained by heating the vein, using emission of laser light.
16168418|NCT01637168|Drug|Panax Ginseng + Ginkgo Biloba + Polyminerals + Multivitamin|A tablet, 2 times daily (12/12 hours).
16168419|NCT01637168|Drug|Ginkgo Biloba (Tebonin®)|A tablet, 2 times daily (12/12 hours).
16168420|NCT01637155|Drug|Cholecalciferol|One baseline oral dose of 50.000 UI to determine pharmacokinetics. After 28 days, patients take a period of 90 days of standardization of cholecalciferol based on baseline levels. After this period, patients receive a second oral dose of 50.000 UI to determine a second pharmacokinetics.
16168421|NCT01637142|Drug|LY2140023|Administered orally.
16168422|NCT01637142|Drug|14C-LY2140023|Administered IV.
16168423|NCT01637142|Drug|14C-LY404039|Administered IV.
16168424|NCT01637129|Device|Transcranial Magnetic Stimulation|Transcranial Magnetic Stimulation, repetitive at 1Hz
16168425|NCT01637129|Device|Sham Magnetic Stimulation|Sham Magnetic Stimulation
16168426|NCT01637103|Behavioral|Cognitive therapy of depression|Cognitive therapy will involve eight individual weekly sessions of 50 minutes with a Ph.D. student in psychology.
16168427|NCT01637103|Behavioral|Bright light therapy|Bright light therapy will consist of a 30-min daily morning exposition to a 10 000-lux BLT lamp during 8 weeks.
16168428|NCT01637090|Drug|Everolimus|"The study drug everolimus will be self-administered (by the patients themselves). The investigator will instruct the patient to take the study drug exactly as specified in the protocol. Everolimus should be administered orally once daily, preferably in the morning, at the same time every day with our without food. Everolimus tablets should be swallowed whole with a glass of water. The tablets must not be chewed or crushed.
~Everolimus will be administered orally as once daily dose of 10 mg continuously from study day 1 until progression of disease or unacceptable toxicity.
~If vomiting occurs, no attempt should be made to replace the vomited dose. All dosages prescribed and dispensed to the patient and all dose changes during the study must be recorded."
16168429|NCT01637077|Drug|pregabalin|Given PO
16168430|NCT01637077|Drug|placebo|Given PO
16168431|NCT01637077|Other|questionnaire administration|Ancillary studies
16168432|NCT01637064|Drug|Acthar|Physicians will prescribe Acthar at their own discretion; however the recommended dose is 80 units subcutaneously twice a week.
16169760|NCT01626560|Drug|Vancomycin|Vancomycin 1g q12h 10 - 14 days
16168433|NCT01637051|Device|Zimmer NexGen® Trabecular Metal Technology (TMT), Monoblock|"A prospective randomized study where the patients are randomized too receive a monoblock tibial component with trabecular metal coating (TMT Zimmer NexGen®) or a modular tibial component (TMT Zimmer NexGen®). Both prostheses are available and approved by the FDA and CE. The only difference between the implants is that of the polyethylene insert (monoblock vs. modular).
~The operations are performed at the Department of Planned Elective Surgery Z, Gentofte Hospital by two experienced TKA surgeons that will be included in the research group. During surgery a minimum of 4 Tantalum markers (0.8 mm) is inserted in the bone of the proximal tibia and 6 markers are inserted in the polyethylene insert."
16168434|NCT01637051|Device|Zimmer NexGen® Trabecular Metal Technology (TMT), Modular|"A prospective randomized study where the patients are randomized too receive a monoblock tibial component with trabecular metal coating (TMT Zimmer NexGen®) or a modular tibial component (TMT Zimmer NexGen®). Both prostheses are available and approved by the FDA and CE. The only difference between the implants is that of the polyethylene insert (monoblock vs. modular).
~The operations are performed at the Department of Planned Elective Surgery Z, Gentofte Hospital by two experienced TKA surgeons that will be included in the research group. During surgery a minimum of 4 Tantalum markers (0.8 mm) is inserted in the bone of the proximal tibia and 6 markers are inserted in the polyethylene insert."
16168435|NCT01637038|Other|RIPC|Those undergoing remote ischemic postconditioning. Remote ischemic postconditioning consists of three 5-min cycles of upper limb ischemia, which was induced by an automated cuff-inflator placed on the unilateral upper limb and inflated to 250 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated.
16168436|NCT01637025|Device|Oxidized cellulose strip|Single use, intra-operative application to the target bleeding site
16168437|NCT01637025|Device|Oxidized regenerated cellulose strip|A substance used to promote hemostasis (stops bleeding) based on oxidized regenerated cellulose
16168438|NCT01637012|Procedure|Implantation|index angioplasty with ALEX stent implatation
16168439|NCT01636999|Drug|50% Nitrous Oxide/50% Oxygen|The gas mixture is provided via the Sedara portable gas delivery system. This system is equipped with a non-rebreather mask which the patient holds over their mouth and nose. The delivery of the gas is only triggered by the patient's spontaneous breath. The gas machine will be provided to the patient to use as much as they like during the 60 minutes data collection period. The only dose which the machine allows to be administered is 50% Nitrous Oxide/50% oxygen.
16168440|NCT01636986|Device|Delefilcon A contact lenses|Silicone hydrogel contact lenses for daily wear, daily disposable use
16168441|NCT01636986|Device|Etafilcon A contact lenses|Hydrogel contact lenses for daily wear, daily disposable use
16168442|NCT01636973|Procedure|Vaporizing humidifier|Vaporizing humidifier applying during one-lung ventilation
16168443|NCT01636960|Biological|PegIFN alfa-2b|
16168444|NCT01636947|Drug|Aprepitant|Aprepitant (125 mg PO, QD) on Day 1, Aprepitant (80 mg PO, QD) on Days 2 and 3
16168445|NCT01636947|Drug|Aprepitant Placebo|Aprepitant Placebo (PO, QD) on Days 1, 2, and 3
16168446|NCT01636947|Drug|Ondansetron|Ondansetron (16 mg, IV, QD) on Day 1 and/or ondansetron (8 mg PO BID) on Days 2 and 3
16168447|NCT01636947|Drug|Dexamethasone|Dexamethasone (20 mg or 12 mg, PO) on Day 1
16168448|NCT01636947|Drug|Ondansetron Placebo|Ondansetron Placebo (PO, BID) on Days 2 and 3
16168449|NCT01636947|Drug|Rescue Therapy (granisetron, dolasetron, tropisetron or ondansetron; metoclopramide or alizapride).|Use of a rescue therapy for nausea and vomiting is permitted throughout the study. Permitted rescue therapies include a drug from among the following classes: 5-hydroxytryptamine (5-HT3) antagonists (granisetron, dolasetron, tropisetron or ondansetron), benzodiazepines, or benzamides (e.g., metoclopramide or alizapride).
16168450|NCT01636934|Drug|Minocycline|100 mg by mouth two times a day (200 mg/day) every day for 7 weeks, starting on the first week of chemoradiation therapy.
16168451|NCT01636934|Other|Placebo|1 capsule by mouth two times a day every day for 7 weeks, starting on the first week of chemoradiation therapy.
16168452|NCT01636934|Behavioral|Questionnaires|Questionnaires at baseline, timepoints during chemoradiation, and at treatment completion for 12 weeks.
16168453|NCT01636908|Drug|Sunitinib|50 mg once daily, oral use, 14 days
16168454|NCT01636908|Drug|Sorafenib|400 mg, twice daily, oral use, 14 days
16168455|NCT01636908|Drug|Erlotinib|150 mg once daily, oral use, 14 days
16168456|NCT01636908|Drug|Everolimus|10 mg once daily, oral use, 14 days
16168457|NCT01636908|Drug|Lapatinib|1250 mg once daily, oral use, 14 days
16168458|NCT01636908|Drug|Dasatinib|100 mg once daily, oral use, 14 days
16168459|NCT01636908|Drug|Pazopanib|800 mg once daily, oral use, 14 days
16168460|NCT01636908|Drug|Vemurafenib|960 mg twice daily, oral use, 15-21 days
16168461|NCT01636908|Procedure|tumor biopsy|
16168462|NCT01636908|Procedure|skin biopsy (optional)|
16168463|NCT01636895|Drug|Efficacy of suphladoxine/pyrimethamine as IPTp|3 tablets (single dose)given twice during pregnancy one month apart after quickening
16168464|NCT01636895|Drug|Efficacy of suphladoxine/pyrimethamine as IPTp|2 courses of 3 tablets of 500 mg N1-(5,6-dimethoxy-4-pyrimidinyl) sulfanilamide (sulfadoxine) and 25 mg 2,4-diamino-5-(p-chlorophenyl)-6-ethylpyrimidine (pyrimethamine)administered (at least 1 month apart) as DOTs to pregnant mother after quickening
16168465|NCT01636882|Biological|CVA21|
16168466|NCT01636869|Drug|Bupivacaine|"20 ml of 0.5% bupivacaine for single-shot femoral nerve block will be done at the beginning then another 20 ml of 0.5% bupivacaine for periarticular block will be performed at the end of operation.
~Blood sample will be drawn at 60 min after femoral nerve block and before periarticular block, 15, 30, 45, 60 min after periarticular block."
16168467|NCT01636856|Behavioral|Oropharyngeal exercises|Oropharyngeal exercises (derived from speech language pathology) to the soft palate, tongue and facial muscles exercises as well as stomatognathic functions.
16168468|NCT01636856|Behavioral|Respiratory exercises, nasal dilator, nasal lavage|Respiratory exercises, nasal dilator, nasal lavage
16168469|NCT01636843|Drug|NNC0109-0012|Administered subcutaneously (s.c., under the skin), once weekly.
16168470|NCT01636843|Drug|placebo|Administered subcutaneously (s.c., under the skin), once weekly.
16168471|NCT01636830|Device|Toothbrush type|Evaluate the use of toothbrushes with bristles soft and medium
16168472|NCT01636817|Drug|NNC0109-0012|Administered subcutaneously (s.c., under the skin) once weekly.
16168476|NCT01636791|Behavioral|Cognitive behavior therapy|Cognitive behavior therapy entails psychoeducational components, i.e. the patient is learns about the disorder and how to view it from a cognitive behavioral perspective. The most important part of the treatment is systematic behavior changes often targeted at exposure to feared stimuli. This is combined with cognitive interventions targeted at challenging negative automatic thoughts. All treatments will be delivered by licensed psychologists.
16168477|NCT01636791|Behavioral|Return to work|Participants randomized to this arm will receive an experimental treatment, based in cognitive behavioral therapy, with primary aim to help patients return to work. Interventions are aimed at solving work-related problems and comprises problem-solving training and systematic employer-patient meetings aimed at facilitating a gradual return to the workplace. Licensed psychologists deliver all treatments.
16168478|NCT01636778|Drug|SB-497115-GR|TPO receptor agonist to increase platelet count
16168479|NCT01636765|Drug|No Intervention|No intervention.
16168480|NCT01636752|Behavioral|Deprexis|Online self-help with and without e-mail-support
16168481|NCT01636739|Biological|Oral Rotarix®|2 doses administered orally.
16168482|NCT01636739|Other|Data collection|Additional information on intussusception will be collected through interview and by phone-contact.
16168483|NCT01636726|Drug|Inhaled LABA use|LABA prescription during the study period between Jan 1, 2002 and Dec 31, 2009
16168484|NCT01636713|Drug|GSK573719/VI 62.5/25|Inhalation via Novel Dry Powder Inhaler Once a day
16168485|NCT01636713|Drug|GSK573719/VI 125/25|Inhalation via Novel Dry Powder Inhaler Once a day
16168486|NCT01636713|Drug|Placebo|Inhalation via Novel Dry Powder Inhaler Once a day
16168487|NCT01636700|Drug|Tramadol 2mg/kg|2mg/kg
16168488|NCT01636700|Drug|Saline solution|saline solution- 1 dose
16168489|NCT01636687|Drug|Placebo|2 injections of placebo to secukinumab 150mg per dose
16168490|NCT01636687|Drug|Secukinumab 150mg|Secukinumab 150mg: 1 injection of 150 mg secukinumab and 1 injection of placebo to secukinumab 150mg per dose. After Week 52 database lock, study is open label so only 1 injection of secukinumab 150mg per dose were administered
16168491|NCT01636687|Drug|Secukinumab 300mg|Secukinumab 300mg (2 injections of 150mg secukinumab per dose)
16168492|NCT01636674|Other|18F-fluordeoxyglucose positron emission tomography/ computed tomography|18F-fluordeoxyglucose positron emission tomography/ computed tomography for preoperative staging and post-operative follow-up
16168493|NCT01636661|Device|tDCS|transcranial direct current stimulation- non-invasive brain stimulation
16168494|NCT01636648|Device|Aortic Valve Replacement|Aortic Valve Replacement with Medtronic ATS 3f ENABLE® Aortic Bioprosthesis Model 6000
16168495|NCT01636635|Other|Calorie Restriction|Intervention consists of a calorically restricted diet regime designed and administered at the Weight and Wellness Center at Tufts University
16168496|NCT01636622|Drug|Vemurafenib|Starting dose of Vemurafenib: 480 mg by mouth mouth in the evening on Day 1 of Cycle 1, then twice a day starting on Day 2 for a 3 week cycle.
16168497|NCT01636622|Drug|Carboplatin|Starting dose of Carboplatin: AUC 5 by vein every 3 weeks.
16168498|NCT01636622|Drug|Paclitaxel|Starting dose of Paclitaxel: 100 mg/m2 by vein every 3 weeks.
16168499|NCT01636609|Drug|Azacitidine|Given IV or SC
16168500|NCT01636609|Drug|Cytarabine|Given SC
16168501|NCT01636609|Drug|Tosedostat|Given PO
16168502|NCT01636596|Drug|Insulin LISPRO|Insulin is delivered in a pulsatile fashion. One treatment is approximately 10-15 units of insulin (exact dose based on weight) split into ten pulses delivered over one hour. Three treatments will be administered per session with one session per week for six month duration.
16168503|NCT01636583|Device|LSF water without meal|Composition of test meal: 67Zn-labelled LSF-fortified water (1 mg 67Zn as ZnSO4 + 1 mg of eluted Zn from LSF device of natural isotopic composition)
16168504|NCT01636583|Device|LSF water and inhibitory meal|Composition of test meal: Maize porridge and 67Zn-labelled LSF-fortified water (1 mg 67Zn as ZnSO4 + 0.44 mg of eluted Zn from LSF device of natural isotopic composition)
16168505|NCT01636583|Other|Fortified inhibitory meal with water|Composition of test meal: Maize porridge (1 mg 67Zn as ZnSO4 + 0.44 mg Zn as ZnSO4 of natural isotopic composition) and high purity water
16168506|NCT01636570|Drug|Placebo Comparator: Sugar Pill|Placebo will be given in identical gelcaps (as microcrystalline cellulose) as 2 per day for a period of 6 months.
16168507|NCT01636570|Drug|Vitamin D3 (cholecalciferol)|10,000 IU vitamin D3 will be given as 5000 IU gelcaps two per day for a period of 6 months.
16168508|NCT01636557|Drug|Sirukumab|Type=exact number, unit=mg, number=300, form=solution for injection, route=subcutaneous use, on Day 8
16168509|NCT01636557|Drug|Midazolam|Type=exact number, unit=mg/kg, number 0.03, form=commercially available form, route=oral use, on Days 1, 15, 29, and 50
16168510|NCT01636557|Drug|Warfarin|Type=exact number, unit=mg, number= 10, form=commercially available form, route=oral use, on Days 1, 15, 29, and 50
16168511|NCT01636557|Drug|Vitamin K|Type=exact number, unit=mg, number =10, form=commercially available form, route=oral use, on Days 1, 15, 29, and 50
16168512|NCT01636557|Drug|Omeprazole|Type=exact number, unit=mg, number=20, form=commercially available form, route=oral use, on Days 1, 15, 29, and 50
16168513|NCT01636557|Drug|Caffeine|Type=exact number, unit=mg, number=100, form=commercially available form, route=oral use, on Days 1, 15, 29, and 50
16168514|NCT01636544|Procedure|contralateral healthy tissue biopsy|At the time of surgery, a part of the specimen, plus a biopsy of the healthy (control) contralateral mucosa (i.e. right border of the tongue for a SCC of the left border, left cheek for a dysplasia of the right cheek and so on) will be harvested for research and immediately frozen at -80°C first in dry ice, then in a -80°C freezer.
16168515|NCT01636531|Drug|gantenerumab|High concentration liquid formulation (HCLF), single dose sc
16168516|NCT01636531|Drug|gantenerumab|Lyophilized formulation (LyoF), single dose sc
16168517|NCT01636518|Procedure|Standard of Care|Standard of care procedure as determined by treating physician for Atrial Fibrillation
16168518|NCT01636505|Drug|ghrh antagonist (cetrotide/orgalutran)|cetrotide/orgalutran 0.25 mg
16168519|NCT01636505|Drug|gnrh agonist (suprefact)|suprefact 5.5 ml
16168520|NCT01636492|Drug|bitopertin|Single oral dose
16168521|NCT01636492|Drug|placebo|Single oral dose
16168522|NCT01636479|Drug|SAR405838|Pharmaceutical form: Capsule Route of administration: Oral
16168523|NCT01636466|Drug|Everolimus|Everolimus will initially be dosed at 0.75 mg tablet taken orally twice a day. The dose will be adjusted to maintain serum trough concentrations of 5-8 ng/ml.
16168524|NCT01636453|Device|Stent assisted coiling with the Liberty Stent|Patients are implanted with the Liberty Stent as an assist to embolic coiling of their wide-neck, saccular, intracranial aneurysms and follow for 12 months
16168525|NCT01636440|Device|Conditioned Pain Modulation|Measure of the conditioned pain modulation with the nociceptive withdrawal reflex and ice water stimulation
16168526|NCT01636440|Device|Conditioned Pain Modulation|Suprathreshold electrical stimulation with 1.5 times the mean electrical pain detection threshold
16168527|NCT01636414|Procedure|Hemovac drain|The Hemovac drain is a device placed under your skin used to collect blood during surgery.
16168528|NCT01636414|Procedure|Re-infusion drain|This device is used during and after surgery to collect blood lost during this time and prepares the blood for possible reinfusion.
16168529|NCT01636414|Procedure|Tranexamic drain|Tranexamic Acid is a synthetic amino acid that prevents the breakdown of blood clots which reduces bleeding.
16168530|NCT01636401|Drug|aclidinium bromide 400 μg|
16168531|NCT01636401|Drug|aclidinium bromide placebo|
16168532|NCT01636388|Biological|allogeneic donor derived LMP specific cytotoxic T-lymphocyte|LMP CTLs will be give at 3 timepoints post allogeneic stem cell transplantation around days 60 to 100, then 30 days apart for the next 2 infusions.
16168533|NCT01636362|Device|Mepitel Ag|Mepitel Ag is an antimicrobial, meshed, non-adherent wound contact layer allowing passage of exudate and providing fixation and protection of tissues.
16168534|NCT01636349|Other|soccer exercise or continued daily lifestyle|Recreational soccer or continued unchanged lifestyle
16168535|NCT01636336|Other|Nicotine|Two doses of nicotine will be utilized in the study: a commercially available, high-yield nicotine cigarette (Marlboro Red; Phillip Morris brand) and a denicotinized cigarette (Murty Pharmaceuticals Inc., Lexington, KY). The high dose cigarettes contain 15.48 mg of nicotine and 16 mg of tar based on analysis by the Massachusetts Department of Public Health (MDPH, 1998). The low nicotine cigarettes contain 1.1 mg of nicotine and deliver 0.1 mg of nicotine and 2.8 mg of tar based on analyses provided by the manufacturer.
16168536|NCT01636336|Other|Progesterone|Prometrium capsules containing 200 mg of micronized progesterone will be obtained from Solvay Pharmaceuticals, Inc. (210 Main Street West, Baudette, MN, 56623, phone (218) 634-3500, fax (218) 634-3540).
16168537|NCT01636323|Other|Nicotine|Subjects will be given two doses of nicotine: a commercially available, high-yield nicotine cigarette (Marlboro Red; Phillip Morris brand) and a denicotinized cigarette (Murty Pharmaceuticals Inc., Lexington, KY). The high dose cigarettes contain 15.48 mg of nicotine and 16 mg of tar based on analysis by the Massachusetts Department of Public Health (MDPH, 1998). According to the Massachusetts Department of Public Health classification, cigarettes with a nicotine yield of 1.2 mg or higher are high nicotine cigarettes. The low nicotine cigarettes contain 1.1 mg of nicotine and deliver 0.1 mg of nicotine and 2.8 mg of tar based on analyses provided by the manufacturer.
16168538|NCT01636310|Other|Nicotine|Two doses of nicotine will be utilized: a commercially available, high-yield nicotine cigarette (Marlboro Red; Phillip Morris brand) and a denicotinized cigarette (Murty Pharmaceuticals Inc., Lexington, KY). The high dose cigarettes contain 15.48 mg of nicotine and 16 mg of tar based on analysis by the Massachusetts Department of Public Health (MDPH, 1998). The low nicotine cigarettes contain 1.1 mg of nicotine and deliver 0.1 mg of nicotine and 2.8 mg of tar based on analyses provided by the manufacturer.
16168539|NCT01636297|Behavioral|Forced exercise|Exercise on a stationary cycle that was controlled by a motor, to augment voluntary cycling rate by 35%. Intervention was administered 3 times per week for 8 weeks
16168540|NCT01636297|Behavioral|Voluntary exercise|Exercise on a stationary cycle without motor assistance. Intervention was administered 3 times per week for 8 weeks
16168541|NCT01636284|Biological|JX-594 recombinant vaccina GM-CSF|Enrolled patients will receive 5 weekly IV infusions on Days 1, 8, 15, 22, and 29. After Day 43, if their disease has improved or remained stable and they have not started other cancer therapy, they may be able to continue to receive JX-594 via IV infusion every three weeks. This treatment extension may continue until radiologic progressive disease, initiation of other cancer therapy, or patient withdrawal.
16168542|NCT01636271|Drug|darapladib|darapladib enteric coated tablets 160 mg
16168543|NCT01636271|Drug|placebo|placebo
16168544|NCT01636258|Behavioral|Stress Management|Every other week
16168545|NCT01636258|Behavioral|Diet|Every other week
16168546|NCT01636258|Behavioral|Exercise|Every week
16168547|NCT01636258|Behavioral|Culinary education|Every other week
16168548|NCT01636245|Biological|three consecutive lots of EV71 vaccine|inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
16168549|NCT01636245|Biological|placebo|placebo, two doses, 28 days interval
16168550|NCT01636206|Drug|Lifitegrast|Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: ~1 year
16168551|NCT01636206|Drug|Placebo|Dosage Form: Ophthalmic Solution Dosage: placebo Frequency: BID Duration: ~1 year
16168552|NCT01636193|Biological|Oral Rotarix®|2 doses administered orally.
16168553|NCT01636193|Other|Data collection|Safety data will be collected through the check of health observation diary and interview of vaccinee's parent.
16168554|NCT01636180|Drug|Clopidogrel|repeated loading dose of clopidogrel (600 mg) in addition to high dose of clopidogrel continuous therapy for 30 days (150 mg/day)
16168555|NCT01636180|Drug|Clopidogrel|no repeated loading dose of clopidogrel with clopidogrel continuous therapy for 30 days (75 mg/day)
16168556|NCT01636167|Device|computerized intraoperative keratomer|computerized intraoperative keratomer can analyze the axis of corneal astigmatism accurately as well as rapidly by self-designed software during surgery
16168557|NCT01636154|Drug|Ixeris of sonchifolia Hance|KDZ40ml+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.
16168558|NCT01636154|Drug|Panax notoginseng saponins|Xueshuantong450mg+0.9%N.S.250ml,ivdrip,qd of each 14-day cycle.Number of cycles:one.
16168559|NCT01636154|Drug|Ixeris of sonchifolia Hance combined with Panax notoginseng saponins|KDZ40ml+0.9%N.S.250ml,ivdrip;0.9%N.S.50ml,ivdrip;Xueshuantong450mg+0.9%N.S.250ml,ivdrip.qd of each 14-day cycle.Number of cycles:one.
16168560|NCT01636141|Drug|OLT1177 Gel|OLT1177 Gel - 3% or 5% administered topically to a defined area of one knee
16168561|NCT01636141|Drug|Placebo gel|
16168562|NCT01636128|Drug|difluoromethylornithine|500 mg oral for 14 days, combined with sulindac for 15 days
16168563|NCT01636128|Drug|Sulindac|150 mg oral for 15 days, combined with DFMO for 14 days
16168564|NCT01636102|Biological|Trivalent influenza virus vaccine (TIV)|A single 0.5 mL dose of the study vaccine supplied in prefilled syringes and administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm
16168565|NCT01636089|Drug|bicarbonates|sodium bicarbonates 1,4%
16168566|NCT01636089|Drug|saline|sodium chloride 0,9%
16168567|NCT01636076|Drug|QMF149|delivered via Concept1 device
16168568|NCT01636076|Drug|Salmeterol|delivered via Accuhaler®
16168569|NCT01636063|Drug|Mifepristone|Mifepristone 200 mg capsulized orally once 24-48 hours prior to abortion procedure
16168570|NCT01636063|Drug|Misoprostol|Misoprostol 400 mcg buccally once 3 hours prior to abortion procedure
16168571|NCT01636050|Other|squat exercise training|Intervention may include squat exercise for 8 weeks
16168572|NCT01636037|Drug|levodopa/carbidopa (generic version of Sinemet)|Oral levodopa 900mg daily as tolerated.
16168573|NCT01636024|Drug|AZD7594|Suspension inhaled via Spira nebuliser
16168574|NCT01636024|Drug|Placebo to match|Matching placebo inhaled via Spira nebuliser
16168575|NCT01636011|Other|Osteopathic Manipulative Medicine Treatment|Osteopathic Manipulative Medicine Treatment
16168576|NCT01636011|Other|Light Touch sham|Light Touch sham
16168577|NCT01635998|Device|Boston Scientific Vessix Renal Denervation System|"Renal sympathetic denervation is modulation of the nerves which run along the renal arteries (the renal sympathetic nerves) with radiofrequency energy. This is the same energy source used to perform your heart ablation.
~Boston Scientific Vessix Renal Denervation System, Boston Scientific, Inc., Quincy, Massachusetts"
16168578|NCT01635985|Drug|AZD5423|solution for injection, administered as intravenous infusion Corr to total dose of 250 µg AZD5423
16168579|NCT01635985|Drug|AZD5423|nebuliser suspension, inhaled via Spira, corr to approximately 300 µg lung deposited dose AZD5423
16168580|NCT01635985|Drug|AZD5423|nebuliser suspension, inhaled via I-neb, corr to approximately 300 µg lung deposited dose AZD5423
16168581|NCT01635985|Drug|AZD5423|nebuliser suspension to be administered orally, corr to a total dose of 1200 µg AZD5423
16168582|NCT01635985|Drug|AZD5423|dry powder inhaled via Turbuhaler, corr to approximately 200 µg lung deposited dose AZD5423
16168583|NCT01635985|Drug|AZD5423|dry powder inhaled via New Dry Powder Inhaler, corr to approximately 200 µg lung deposited dose AZD5423
16168584|NCT01635972|Drug|Isavuconazole|oral
16168585|NCT01635972|Drug|bupropion hydrochloride|oral
16168586|NCT01635946|Drug|Isavuconazole|oral
16168587|NCT01635946|Drug|atorvastatin|oral
16168588|NCT01635933|Device|Lotrafilcon B contact lens with color|Silicone hydrogel contact lens with color.
16168589|NCT01635933|Device|Phemfilcon A contact lens with color|Hydrogel contact lens with color.
16168590|NCT01635920|Device|Lotrafilcon B contact lens with color|Silicone hydrogel contact lens with color
16168591|NCT01635920|Device|Lotrafilcon B contact lens|Silicone hydrogel contact lens
16168592|NCT01635907|Drug|Dovitinib|
16168593|NCT01635894|Behavioral|Training|Women in both the practice nurse and specialist nurse groups were given supervised pelvic floor exercise training. After the initial training they were given a daily exercise regimen and seen at monthly intervals for three months. The practice nurses had attended a study day on supervising Pelvic Floor Muscle Training(PFMT)followed by practice sessions with patients overseen by the nurse specialist.
16168594|NCT01635881|Device|Emerge™ 1.20 mm PTCA Dilatation Catheter|"The Emerge 1.20 mm device is the next-generation Boston Scientific PTCA dilatation catheter. It is a sterile, single-use, intravascular medical device used to improve lumen diameter.
~The catheter consists of a shaft with a balloon near the distal tip. The balloon is designed to provide an inflatable segment of known diameter and length at recommended pressures."
16168595|NCT01635855|Device|Belotero®|Hyaluronic acid dermal filler
16168596|NCT01635829|Drug|Telaprevir|Type=exact number, unit=mg, number=375, form=tablet, route=oral. Two tablets of telaprevir will be administered as per the dosing regimens for each part of both the panels.
16168597|NCT01635829|Drug|Phenytoin|Type=exact number, unit=mg, number=100, form=capsule, route=oral. Two capsules of phenytoin will be administered as per the dosing regimen in Part 2 of Panel 1.
16168598|NCT01635829|Drug|Carbamazepine|Type=exact number, unit=mg, number=200, form=tablet, route=oral. One tablet of carbamazepine will be administered as per dosing regimen in Part 2 of Panel 2.
16168599|NCT01635816|Biological|JE Vaccine existing facility|Will receive JE live attenuated SA 14-14-2 vaccine manufactured in the existing facility (250 infants).
16168600|NCT01635816|Biological|JE vaccine new plant lot 1|Will receive Lot 1 JE live attenuated SA 14-14-2 vaccine manufactured in the new GMP facility (250 infants).
16168601|NCT01635816|Biological|JE vaccine new plant lot 2|Will receive Lot 2 JE live attenuated SA 14-14-2 vaccine manufactured in the new GMP facility (250 infants).
16168602|NCT01635816|Biological|JE vaccine new plant lot 3|Will receive will receive Lot 3 JE live attenuated SA 14-14-2 vaccine manufactured in the new GMP facility (250 infants).
16168603|NCT01635803|Drug|Bevacizumab|1.25 mg bevacizumab administered by monthly interval for six months (6 injections).
16168604|NCT01635803|Drug|Ranibizumab|0.5mg ranibizumab administered by monthly interval for six months (6 injections).
16168605|NCT01635790|Drug|Ranibizumab|0.5 mg ranibizumab. Given as monthly intravitreal injections during 6 months
16168606|NCT01635790|Drug|Bevacizumab|1.25 mg of bevacizumab; Given as monthly intravitreal injections during 6 months
16168607|NCT01635777|Drug|Miltefosine|2.5 mg/kg/day for 12 weeks
16168608|NCT01635777|Drug|Miltefosine|2.5 mg/kg/day for 8 weeks
16168609|NCT01635764|Biological|adalimumab|Adalimumab pre-filled syringe, administered by subcutaneous injection
16168610|NCT01635751|Drug|Pregabalin|GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, fasted)
16168611|NCT01635751|Drug|Pregabalin|GLA5PR GLARS tablet 150mg/day(Pregabalin 150mg once a day, after high fat meal)
16168612|NCT01635751|Drug|Pregabalin|Lyrica Capsule 150mg/day(Pregabalin 75mg twice a day, fasted)
16168613|NCT01635738|Biological|LP GMNL-133 capsule|One capsule with 2x10^9 (cfu) LP GMNL-133, once daily, PO
16169761|NCT01626534|Drug|Clopidogrel|600mg loading dose then 75mg/day
16168614|NCT01635738|Biological|LF GM-090 capsule|Arm: LF GM-090 group One capsule with 2x10^9 (cfu) LF GM-090, once daily, PO
16168615|NCT01635738|Biological|LP GMNL-133 +LF GM-090 capsule|One capsule with 4x10^9 (cfu) LP GMNL-133 +LF GM-090, once daily, PO
16168616|NCT01635738|Biological|Placebo|Placebo
16168617|NCT01635712|Drug|SNX-5422|Capsule dosed every other day for 21 days out of 28 day cycle. Dose escalation based on safety
16168618|NCT01635686|Drug|DWP422 25mg|
16168619|NCT01635686|Drug|ENBREL 25MG PFS INJ.|
16168620|NCT01635673|Other|Exercise intervention|Whole body vibration exercise 3 times per week
16168621|NCT01635660|Device|Intubation|Tracheal Intubation with the assigned video laryngoscope
16168622|NCT01635647|Biological|ChAd63 ME-TRAP and MVA ME-TRAP|ChAd63 ME-TRAP: 5 x 10^10vp MVA ME-TRAP: 1 x 10^8 pfu heterologous prime-boost immunisation
16168623|NCT01635647|Biological|Rabies vaccine|Two doses eight weeks apart into anterolateral thigh. 2 x 2.5IU Verorab
16168624|NCT01635634|Other|Cupping therapy|Cups are placed at the skin; local suction is created on the skin; it mobilizes blood flow; the suction is created by a mechanical device (Pneumatron, Pneumed, Germany)
16168625|NCT01635621|Drug|Olokizumab (OKZ)|"Subjects will receive one of the following treatment regimens as subcutaneous injection solution on Weeks 0, 2, 4, 6, 8, 10, 12 and 14 of the Treatment Period:
~OKZ 120 mg every 2 weeks
~OKZ 240 mg every 2 weeks
~OKZ 120 mg every 2 weeks, with a loading dose of OKZ 480 mg at Week 0
~1.6 mL of OKZ drug substance presented in a glass vial with a 1.2 mL extractable volume at a concentration of 100 mg/mL in the formulation buffer, containing 25 mM sodium citrate, 90 mM sodium chloride, 0.02 % (weight/volume) polysorbate 80, pH 6.0."
16168626|NCT01635621|Drug|Placebo|Subjects will receive Placebo every 2 weeks as a subcutaneous injection solution (0.9% sodium chloride preservative-free for injection) on Weeks 0, 2, 4, 6, 8, 10, 12 and 14 of the Treatment Period.
16168627|NCT01635608|Drug|Acetaminophen|administration of 500 mg paracetamol
16168628|NCT01635608|Drug|Talinolol|administration of 50 mg talinolol
16168629|NCT01635608|Drug|Amoxicillin|administration of 500 mg amoxicillin
16168630|NCT01635608|Other|non-caloric water|administration of 240 ml water
16168631|NCT01635608|Other|caloric water|administration of 240 ml caloric water (containing 25.5 g sucrose)
16168632|NCT01635595|Procedure|Subtotal esophagectomy and gastric pull up|Subtotal esophagectomy and gastric pull up and radical thoracic (2,3,4R,7,8,9)and abdominal (15,16,17,18,19,20) lymphadenectomy
16168633|NCT01635595|Procedure|Subtotal esophagectomy at the azygos vein, total gastrectomy|Subtotal esophagectomy at the azygos vein, total gastrectomy and esophagojejunostomy and radical thoracic (2,3,4R,7,8,9) abdominal (15,16,17,18,19,20) lymphadenectomy.
16168634|NCT01635582|Other|Conventional hand exercise program|Exercises targeted to improve finger range of motion and hand strength.The exercises will be performed 30 minutes,four times per week for six weeks
16168635|NCT01635582|Other|Computer gaming hand exercise regimen|Computer gaming hand exercise regimen using common objects of daily life. The hand exercises are coupled with commercially available computer games and will be performed 30 minutes,four times per week for six weeks
16168636|NCT01635569|Behavioral|Group-based family cognitive-behavioural therapy|Baseline and post-12 sessions
16168637|NCT01635569|Other|Waitlist|Baseline and post-12 sessions
16168638|NCT01635556|Behavioral|Dialectical Behavior therapy|Weekly psychotherapy of both individual and group sessions
16168639|NCT01635530|Drug|Doxycycline|Doxycycline: 100mg tablet two times per day, four weeks
16168640|NCT01635530|Drug|Ceftriaxone|2 g intravenous once a day, three weeks
16168641|NCT01635504|Biological|Botulinum toxin A|Botulinum toxin A 50 units per side of the posterior cheek enlargement, injected into the masseter muscle and parotid gland (10 units into 5 points of the posterior cheek enlargement per side, giving a total of 100 units per patient)
16168642|NCT01635439|Drug|Propess|The vaginal insert is removed 24 h after the application. It is only to be removed earlier in case of the onset of active labour, the rupture of the membranes, or at the occurrence of hyperstimulation.
16168643|NCT01635439|Drug|Prostin E2|3 mg tab is placed in the posterior vaginal fornix. dose can be repeated every 6 hours till onset of active labour, the rupture of the membranes, or the occurrence of hyper-stimulation.
16168644|NCT01635426|Drug|Aspirin|Aspirin 75 mg daily for 2 months after meals
16168645|NCT01635426|Drug|Clopidogrel|Clopidogrel 75 mg daily for 2 months after meals
16168646|NCT01635413|Behavioral|Exercise Intervention|Undergo strength training classes
16168647|NCT01635413|Behavioral|Exercise Intervention|Undergo tai chi classes
16168648|NCT01635413|Behavioral|Exercise Intervention|Undergo stretching and relaxation classes
16168649|NCT01635413|Other|Questionnaire Administration|Ancillary studies
16168650|NCT01635400|Drug|Irinotecan|irinotecan 180mg/m2 i.v. over 30 min d1,q2w
16168651|NCT01635387|Drug|aliskiren|150 mg once a day per 2 week with forced uptitration to 300 mg once a day, if tolerated
16168652|NCT01635374|Procedure|Per-Oral Endoscopic Esophagomyotomy|In this procedure, performed in the operating room under general anesthesia, a flexible endoscope is passed into the esophagus, a mucosal flap and a submucosal tunnel is created. This tunnel extends onto the stomach. The inner circular muscle layer of the lower esophagus and sphincter (LES) is identified and a myotomy is started 3-4cm distal to the mucosal flap and carried all the way onto the stomach. The mucosal opening is then closed with standard endoscopic clips. Patients will be admitted to the hospital and a gastrograffin esophagram will be performed on post-op day 2 to rule out esophageal leak. A standardized symptom checklist will be used to assess patient's prior to hospital discharge and on post-op days 4 and 7. All patient will have a 2 week post-op appointment.
16168653|NCT01635361|Other|New Medicine Service|The New Medicine Service is an intervention where patients prescribed a new medicine receive followup consultations with the pharmacist 7-14 days and 14-21 days after receiving the new prescription item
16168695|NCT01635062|Drug|Calcitriol|Subjects will receive calcitriol (up to 0.75 mcg daily) for 3 weeks.
16168696|NCT01635062|Drug|Placebo|Subjects will receive placebo for 3 weeks.
16168697|NCT01635036|Device|In-vitro fertilization using Eeva|Eeva will image embryos through cleavage stage (Day 3). Embryologists will use Eeva results along with traditional morphological grading to assist in selecting embryo(s) for transfer or freezing.
16170025|NCT01624285|Other|laboratory biomarker analysis|Correlative studies
16168654|NCT01635348|Behavioral|motor skill gait exercise|The motor skill gait exercise is a task-oriented motor sequence learning approach to exercise to improve walking. The approach involves goal-directed stepping and walking patterns to facilitate use of the appropriate muscles at the appropriate timing relative to body position during gait through the task performance. Treadmill-assisted walking in brief intervals of small increased speed walking interspersed with usual walking speed are performed to induce the automatic rhythm and timing of gait. The exercise sessions are about 60 minutes, 2-3 times a week for 12 weeks or a total of 30-36 sessions.
16168655|NCT01635348|Behavioral|aerobic gait intervention|The aerobic gait intervention approach involves treadmill and overground walking with the gradual increases in the distance walked and speed of walking. The exercise approach provides walking practice, including on the treadmill to facilitate the timing of stepping during gait, while also facilitating a fitness or conditioning response, and endurance for walking activities. The exercise sessions are about 60 minutes, 2-3 times weekly for 12 weeks, or about 30-36 sessions.
16168656|NCT01635335|Behavioral|Latino STYLE|7-hour family-based workshop with 3-hour follow-up booster 3 months later
16168657|NCT01635322|Device|Polyaxial posterior spinal fusion system|posterior correction and fusion of the thoraco-lumbar or lumbar spine
16168658|NCT01635309|Other|Coronary CT Angiogram|pre-operative coronary CTA
16168659|NCT01635296|Drug|RO5045377|Multiple escalating oral doses, Days 1 to 10 of each 28-day cycle
16168660|NCT01635296|Drug|RO5045377|Multiple escalating oral doses, Days 1 to 5 of each 28-day cycle
16168661|NCT01635296|Drug|cytarabine|20 mg/m2 sc, Days 1 to 10 of each 28-day cycle
16168662|NCT01635296|Drug|cytarabine|1 gm/m2 iv, Days 1 to 6 of each 28-day cycle
16168663|NCT01635283|Biological|tumor lysate-pulsed autologous dendritic cell vaccine|Given ID
16168664|NCT01635283|Other|laboratory biomarker analysis|Correlative studies
16168665|NCT01635270|Radiation|mid-position radiation strategy|The midP strategy defines the target as the time weighted average tumor position (mid-position) plus an additional margin, computed specifically for each patient, that takes into account the tumor motion in each direction. This strategy can help to safely reduce toxicity while preserving treatment efficacy
16168666|NCT01635270|Radiation|ITV|The ITV strategy is the conventional one. It consists in defining the target as the volume covering the whole tumor motion.
16168667|NCT01635257|Other|Ultrasound scan|A multiorgan ultrasound was performed by an emergency physician sonographer before MCTPA. Pulmonary embolism was considered echographically present if compression ultrasound was positive for deep vein thrombosis or transthoracic-echocardiography was positive for right ventricular dysfunction or at least one pulmonary subpleural infarct was detected with thoracic ultrasound.
16168668|NCT01635244|Device|Aortic valve replacement|Clinically indicated aortic valve replacement will be performed using one of three approved tissue valves (Freestyle, Magna Ease, or Trifecta).
16168669|NCT01635231|Other|hypertonic saline|hypertonic saline 3.0% 7 ml/kg
16168670|NCT01635218|Drug|Individualized homeopathic treatment|A single dose of the individualized homeopathic remedy in C-potency was dissolved in a 60 ml bottle of 30% alcohol-distilled water:15 drops PO two times per day following agitation plus fluoxetine-dummy loaded PO daily during 6 weeks. The homeopathic remedy could be changed at every follow-up (week 4) according to patient´s symptoms.
16168671|NCT01635218|Drug|Fluoxetine|20 mg per day PO during 6 weeks plus individualized homeopathic dummy-loaded (60 bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic dummy-loaded was repeated at week 4.
16168672|NCT01635218|Drug|Placebo|Fluoxetine placebo (capsules containing sucrose microgranules) PO daily during 6 weeks plus individualized homeopathic placebo (60 ml bottle of 30% alcohol-distilled water: 15 drops PO two times per day following agitation). The individualized homeopathic placebo was repeated at week 4.
16168673|NCT01635205|Procedure|paraspinous anesthetic block|Paraspinous anesthetic block with lidocaine 1% in sensitized segments of the thoracolumbar region
16168674|NCT01635205|Procedure|subcutaneous puncture with no anesthetic effect|Subcutaneous puncture with injection needle (no substance will be injected)
16168675|NCT01635192|Biological|VSL#3|"The probiotic product VSL#3® comes in a powder (sachet) that is to be dissolved in half a glass of cold water before ingestion. Two sachets are ingested once daily over 2 weeks.
~Each dose (sachet) contains 450 billion live (lyophilized) lactic acid bacteria (in defined ratios of the following strains: Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis, Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus paracasei, Lactobacillus bulgaricus, Streptococcus thermophilus) and are delivered in a base of maltose and silicon dioxide."
16168676|NCT01635192|Biological|Placebo|Two placebo sachets containing maltose and silicon dioxide are given once daily over 2 weeks.
16168677|NCT01635179|Procedure|Cricoid pressure|The patient is intubated twice, once with a cricoid pressure and once with a sham-pressure, when performing a videolaryngoscopy.
16168678|NCT01635166|Device|Delta Motion|A cementless acetabular cup with a pre-assembled ceramic liner for use in total hip replacement.
16168679|NCT01635153|Dietary Supplement|Protein calorie supplement|Fortified porridge with 1062 kcal and 40 gm protein
16168680|NCT01635153|Dietary Supplement|Micronutrient|Dar-vite Multivitamin
16168681|NCT01635140|Radiation|Hypofractionated radiotherapy|A total dose of 39 Gy in daily fractions of 3 Gy, 5 Fractions per week
16168682|NCT01635140|Radiation|Conventional arm|A total dose of 54 Gy in 30 fractions giving 1.8 Gy per fraction.
16168683|NCT01635127|Drug|Canakinumab|150mg s.c.
16168684|NCT01635127|Drug|Placebo|Constituent of canakinumab
16168685|NCT01635114|Dietary Supplement|resveratrol|150 mg resVida per day for 12 weeks
16168686|NCT01635114|Dietary Supplement|Placebo|Placebo for 12 weeks
16168687|NCT01635101|Drug|IV Acetaminophen|IV Acetaminophen given every 6 hours (q6h); 4 doses, in 24 hours
16168688|NCT01635101|Drug|IV Control|IV Control q6h; 4 doses, in 24 hours
16168689|NCT01635088|Drug|Mometasone furoate 220|dry powder inhaler QD for 28-43 days
16168690|NCT01635088|Device|KoKo Spirometry|
16168691|NCT01635088|Drug|Mometasone furoate 440|dry powder inhaler QD for 28-43 days
16168692|NCT01635088|Device|Oscillometry|
16168693|NCT01635075|Behavioral|Exercise|1-mile treadmill walk
16168694|NCT01635075|Behavioral|passive control|20 min inactivity
16170391|NCT01621178|Drug|Dulaglutide|Administered SC
16168698|NCT01635023|Drug|AZD6244 Dosing Period 1|Treatment A, B, or C depending on randomization assignment
16168699|NCT01635023|Drug|AZD6244 Dosing Period 2|Treatment A, B, or C depending on randomization assignment
16168700|NCT01635023|Drug|AZD6244 Dosing Period 3|Treatment A, B, or C depending on randomization assignment
16168701|NCT01635023|Drug|AZD6244 Dosing Period 4|Treatment B
16168702|NCT01635010|Procedure|continuous positive airway pressure (CPAP)|CPAP pressure is individually prescript according to polysomnography for CPAP titration
16168703|NCT01634971|Procedure|Internal Drainage of Pancreatic Duct after pancreatomy|the Intervention name is: Internal Drainage of Pancreatic Duct after pancreatomy, a stent was placed in the pancreatic duct, external drainage of the stent is defined as control group(the stent will be tans-abdomen and as a drainage of pancreatic fluid), and internal drainage of the stent is defined as interventional(or experimental) group, with the stent very short(2cm) and placed in jejunum.
16168704|NCT01634958|Biological|Depigoid Phleum|Suspension for subcutaneous injection Build-up phase (day 1): 0,1mL + 0,2mL + 0,2mL s.c.injections in intervals of 30 minutes Maintenance phase: 5x single s.c. injection of 0,5mL every 4 weeks
16168705|NCT01634945|Drug|SP/amodiaquine|One dose of SP (500 mg sulfadoxine plus 25 mg pyrimethamine, or half of the dose if body weight =< 10 kg) and three daily doses of Amodiaquine (1. Day: 200 mg, 2. Day: 200 mg and 3. Day: 100 mg, or half of the dose each day if body weight =< 10 kg), every three months, i.e. 3 times during 9 consecutive months.
16168706|NCT01634945|Dietary Supplement|FeFum fortified porridge|6 times per week supply of iron fortified porridge (25 g portion containing 5.8 mg of iron: 2 mg as NaFeEDTA + 3.8 mg as ferrous fumarate) for 9 months.
16168707|NCT01634945|Drug|SP/Amodiaquine + FeFum fortified porridge|"One dose of SP (500 mg sulfadoxine plus 25 mg pyrimethamine, or half of the dose if body weight =< 10 kg) and three daily doses of Amodiaquine (1. Day: 200 mg, 2. Day: 200 mg and 3. Day: 100 mg, or half of the dose each day if body weight =< 10 kg), every three months, i.e. 3 times during 9 consecutive months.
~6 times per week supply of iron fortified porridge (25 g portion containing 5.8 mg of iron: 2 mg as NaFeEDTA + 3.8 mg as ferrous fumarate) for 9 months."
16168708|NCT01634945|Dietary Supplement|Ferric pyrophosphate fortified porridge|6 days per week supply of iron fortified porridge (25 g portion containing 5.8 mg of iron: 2 mg as NaFeEDTA + 3.8 mg as ferric pyrophosphate) for 9 months.
16168709|NCT01634945|Other|Placebo|Placebo of SP/Amodiaquine every 3 months for 9 months. No dietary intervention.
16168710|NCT01634932|Other|Regular iron|Labeled iron as FeSO4 will be added as a tag to a test meal consumed over 5 consecutive days for breakfast and for lunch
16168711|NCT01634932|Other|Iron biofortified millet|Labeled iron as FeSO4 will be added as a tag to a test meal consumed over 5 consecutive days for breakfast and for lunch
16168712|NCT01634932|Other|Post-harvest iron-fortifed millet|Labeled iron as FeSO4 will be added as a tag to a test meal consumed over 5 consecutive days for breakfast and for lunch
16168713|NCT01634919|Device|chronic hepatitis C|acoustic radiation force impulse ultrasonography
16168714|NCT01634906|Drug|Temporary discontinuation of statin therapy|All statins, e.g. atorvastatin, simvastatin, fluvastatin, rosuvastatin, pravastatin
16168715|NCT01634893|Drug|Sorafenib combined with Hydroxychloroquine|"dose escalation of sorafenib combined with hydroxychloroquine (HCQ) to a maximum of sorafenib 400 mg PO BID plus HCQ 400 mg PO QD.
~Drugs are given on an intermittent schedule of days 1-5/week in a 28-day cycle.
~Sorafenib alone is given in cycle 1, and HCQ is added in cycle 2."
16168716|NCT01634880|Drug|Postoperative Radiotherapy and Panitumumab|"The starting panitumumab dose is 2.5 mglkg given once a week. The total dose may be rounded up or down by no greater than 10 mg. The panitumumab dose will be calculated based on the subject's actual weekly body weight.
~Standard radiation 64-70Gy with 2.0 Gy daily fractions in 6-7 weeks. Panitumumab 2.5 mg/Kg IV, weekly during radiation (total of 6-7 doses)."
16168717|NCT01634854|Drug|Vaginal Misoprostol|Dosage: 25 µg every 4 hours up to a maximum of 4 doses until cervical change is consistent with a diagnosis of active labor Route of administration: Intravaginal
16168718|NCT01634854|Drug|Intravenous Oxytocin|"Dosage: 2 miu per minute increased in increments of 1-2 miu per minute every 30 minutes to establish an effective contraction pattern.
~Route of administration: intravenous"
16168719|NCT01634841|Dietary Supplement|Walnuts|30 to 60g (1 to 2 oz) per day of walnuts
16168720|NCT01634841|Other|habitual diet|Dietary information will be provided
16168721|NCT01634815|Procedure|The Edge|measuring blood lactate
16168722|NCT01634802|Other|EMR Only|Clinics in this arm of the study will have a standard Electronic Medical Record (EMR) system installed - without a computerized decision support system.
16168723|NCT01634802|Other|EMR+CDSS|Clinics in this arm of the study will have an Electronic Medical Record (EMR) system with Clinical Decision Support System (CDSS) enhancement implemented as alerts to aid the clinician in decision making.
16168724|NCT01634789|Drug|bazedoxifene|20 mg oral tablet, single dose
16168725|NCT01634789|Drug|bazedoxifene|20 mg oral tablet, single dose
16168726|NCT01634789|Drug|bazedoxifene|20 mg oral tablet, single dose
16168727|NCT01634789|Drug|bazedoxifene/conjugated estrogens|20 mg / 0.625 mg oral tablet, single dose
16168728|NCT01634776|Dietary Supplement|Flaxseed oil|Families will be asked to mix the contents of one capsule (1200 mg flaxseed oil or 1288 mg corn oil) into a cup of participants' food, twice a day.
16168729|NCT01634776|Dietary Supplement|corn oil|
16168730|NCT01634763|Drug|LDK378|
16168731|NCT01634750|Drug|ManNAc|Single dose
16168732|NCT01634724|Drug|a drug withdrawal during the long protocol|GnRHa (triptorelin,0.05mg/d) was injected stimulously with FSH before dominant follicles were ≥ 14 mm. When the diameter of one or more follicles was ≥ 14 mm, GnRHa (triptorelin,0.05mg/d) was withheld in the study group.
16168733|NCT01634711|Device|L-C Ligament|The L-C Ligament is a bioresorbable, three-dimensional (3-D) braided scaffold made from poly L-lactic acid (PLLA) fiber. One device is used to replace the ACL. The L-C Ligament is an interventional device. The L-C Ligament is comprised of three regions: (1) The femoral tunnel attachment site, (2) The ligament region (intra-articular zone), and (3) The tibial tunnel attachment site. For several months after surgery, the L-C Ligament replaces the function of the ACL. During this time, ligament tissue regenerates within and around the L-C Ligament, which is slowly absorbed and replaced by the ACL.
16168734|NCT01634698|Dietary Supplement|retinyl palmitate (UNICEF, Melbourne, Australia)|the patients received an oral dose of 1500 IU or 2500 IU, once.
16168735|NCT01634685|Radiation|Radiation|Radiation therapy will be administered daily, Monday-Friday, for a total of 28 treatments, delivered at 1.8 Gy/fraction.
16168736|NCT01634685|Drug|Bavituximab|Bavituximab will be delivered concurrently with the radiation therapy for 6 weeks (one time each week), followed by 2 weeks of bavituximab administration by itself.
16168737|NCT01634685|Drug|Capecitabine|capecitabine, will be delivered twice daily p.o. on the days of radiation treatment, at a dose of 825 mg/m2.
16168738|NCT01634659|Device|Delefilcon A contact lenses (DAILIES TOTAL1®)|Commercially marketed silicone hydrogel, single-vision contact lenses for daily wear, daily disposable use
16168739|NCT01634659|Device|Narafilcon B contact lenses (1-DAY ACUVUE® TruEye®)|Commercially marketed, silicone hydrogel single-vision contact lenses for daily wear, daily disposable use
16168740|NCT01634646|Dietary Supplement|Lyzme5|"Dietary Supplement (or placebo):
~Lyzme5 (or the placebo) is to be mixed with 4 fluid ounces of a sugar free flavored drink (example: kool aid, crystal light, flavored tea drink, etc.).
~Week one:
~A single serving of the assigned material (Lyzme5 or the placebo) each day, 20 minutes before breakfast;
~Week two:
~Two (2) servings of the assigned material each day - the first, 20 minutes before breakfast and the second 20 minutes before the noon meal;
~Week three through the end of the study:
~Three (3) servings per day of the assigned material - the first, 20 minutes before breakfast, the second, 20 minutes before the noon meal, and the third, 20 minutes before the last meal of the day."
16168741|NCT01634620|Device|NIOX MINO® Instrument (09-1100)|"FeNO measurements will be performed according to the Perform FeNO Measurement guidelines on page 7 of the NIOX MINO® User Manual (February, 2011)"
16168742|NCT01634594|Drug|Group R|
16168743|NCT01634594|Drug|Group N|
16168744|NCT01634594|Drug|Group D|
16168745|NCT01634568|Drug|V81444|"Single ascending oral doses of V81444 and placebo
~Multiple ascending oral doses of V81444 and placebo"
16168746|NCT01634555|Biological|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B) 8 milligrams per kilogram (mg/kg), administered as an intravenous (IV) infusion on Day 1 of each 2-week cycle (except Cycle 1)
16168747|NCT01634555|Drug|Irinotecan|180 milligrams per square meter (mg/m²) administered IV on Day 1 of each cycle
16168748|NCT01634555|Drug|Folinic acid|400 mg/m² administered IV on Day 1 of each cycle
16168749|NCT01634555|Drug|5-Fluorouracil|400 mg/m² bolus over 2 to 4 minutes administered IV on Day 1 of each cycle, followed by 2400 mg/m² administered IV over 46 to 48 hours on Days 1 and 2 of each cycle
16168750|NCT01634529|Drug|V158866|Single ascending oral doses of V158866 and Placebo
16168751|NCT01634529|Drug|V158866|Multiple ascending oral doses of V158866 and Placebo
16168752|NCT01634516|Behavioral|Dietary support|Face to face intervention plus subsequent telephone support
16168753|NCT01634516|Behavioral|No dietary support|No face to face intervention or subsequent telephone support
16168754|NCT01634503|Genetic|GX-188E administered by electroporation|Patients will be assigned to three dose groups:1mg, 2mg, and 4mg. Each patient will be administered GX-188E by electroporation in entire study period. The Maximum Tolerated Dose of GX-188E will be determined by the classical 3+3 dose escalation schedule. The number of patients will be ranged from 9 to 18.
16168755|NCT01634451|Other|Bespoke on-line sedation education package|A bespoke on-line education package has been developed and will be accessible by all ICU nursing staff. They will have unique logins and the system will track their use and completion of the education package. There is a small multiple choice assessment at the end of the package.
16168756|NCT01634451|Other|Sedation specific outcome process feedback|Using statistical process charts, the data gathered from the Sedation quality Tools (SQATs) completed each shift by the ICU nurses, will be fed back highlighting sedation specific outcomes e.g. number of over sedated days per 1000 ventilator days.
16168757|NCT01634451|Device|Responsiveness monitoring; novel sedation monitor|Responsiveness monitoring (developed by GE Healthcare) is a novel technology used to monitor patient responsiveness and essentially alert ICU nursing staff when their patients may be over sedated.
16168758|NCT01634438|Drug|unfractionated heparin|unfractionated heparin
16168759|NCT01634425|Device|Alere Triage Meter Pro|Troponin and BNP measured on point of care meter.
16168760|NCT01634412|Drug|SL TNX-102 2.4 mg at pH 3.5|1 dose of 2.4 mg TNX-102 sublingual solution (2.4 mg/mL) in PBS at pH 3.5, administered as 1 mL held under the tongue for 90 seconds without swallowing
16168761|NCT01634412|Drug|SL TNX-102 2.4 mg at pH 7.1|1 dose of 2.4 mg TNX-102 sublingual solution (2.4 mg/mL) in PBS at pH 7.1, administered as 1 mL held under the tongue for 90 seconds without swallowing
16168762|NCT01634412|Drug|Cyclobenzaprine Tablet|1 x 5 mg cyclobenzaprine tablet, swallowed with 240 mL of room-temperature water
16168763|NCT01634412|Drug|Cyclobenzaprine IV|1 dose of 2.4 mg cyclobenzaprine USP in PBS (0.6 mg/mL) at pH 7.4, administered intravenously as a 4 mL bolus injection over 30 seconds
16168764|NCT01634399|Drug|Torrent's Quetiapine Fumarate Tablets|
16168765|NCT01634386|Drug|Torrent's Quetiapine Fumarate Tablets|
16168766|NCT01634373|Drug|Torrent's Quetiapine Fumarate Tablets|
16168767|NCT01634360|Drug|Perampanel|1mg once daily for two weeks, followed by 2mg once daily for 2 weeks; if they did not tolerate the 1 mg dose, subjects were withdrawn from the study. Subjects could be up-titrated to 3 or 4 mg in a sequential manner. Subjects could be down-titrated at any time to either 3, 2 or 1 mg in a sequential manner.
16168768|NCT01634347|Drug|Propranolol and memory reactivation|Propranolol will be administered once a week for a 3 or 6 week period. Each propranolol administration will be followed by memory reactivation.
16168769|NCT01634347|Drug|Placebo and memory reactivation|Placebo will be administered once a week for a 3 or 6 week period. Each placebo administration will be followed by memory reactivation.
16168770|NCT01634334|Behavioral|Real-Time Intervention|Lights and Sound Brief Coaching
16168771|NCT01634334|Behavioral|Usual Education|Participants will receive usual education about secondhand smoke and thirdhand smoke.
16168772|NCT01634321|Drug|Luphere depot 3.75mg(Leuprolide acetate 3.75mg)|
16168773|NCT01634308|Drug|Novosis(bongros/BMP-2)|
16168774|NCT01634308|Drug|Bio-oss|
16168775|NCT01634295|Drug|CKD-828 2.5/40mg|"Fixed dose combination of S-amlodipine 2.5mg and Telmisartan 40mg QD 2 weeks.
~With the others investigation product placebo 4 tabs QD 2 weeks."
16168776|NCT01634295|Drug|CKD-828 5/40mg|"Fixed dose combination of S-amlodipine 5mg and Telmisartan 40mg QD 2 weeks.
~With the others investigation product placebo 4 tabs QD 2 weeks."
16168777|NCT01634295|Drug|CKD-828 5/80mg|"Fixed dose combination of S-amlodipine 5mg and Telmisartan 80mg QD 6 weeks.
~With the others investigation product placebo 4 tabs QD 6 weeks."
16168778|NCT01634295|Drug|S-amlodipine 2.5mg|"S-amlodipine 2.5mg QD 4 weeks
~With the others investigation product placebo 4 tabs QD 4 weeks."
16168779|NCT01634295|Drug|S-amlodipine 5mg|"S-amlodipine 2.5mg QD 6weeks
~With the others investigation product placebo 4 tabs QD 6 weeks."
16168780|NCT01634282|Drug|OPC-262|Orally administered once daily
16168781|NCT01634269|Device|MDT-2111 TAVI 23 mm|Device: 23 mm MDT-2111 System for Transcatheter Aortic Valve Implantation (TAVI) Transcatheter Aortic Valve Implantation (TAVI) using the 23 mm MDT-2111 system.
16168782|NCT01634256|Dietary Supplement|Placebo|Placebo(3.0g/day)
16168783|NCT01634256|Dietary Supplement|Fermented turmeric|Fermented turmeric(3.0g/day)
16168784|NCT01634243|Drug|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
16168785|NCT01634230|Drug|OCR-002|daily dose: 10 g infused over 24 hours
16168786|NCT01634217|Biological|iTreg|The iTregs will be infused at the assigned dose without a filter or pump slowly by gravity over 15-60 minutes. The iTregs should be given at least 4 hours before the peripheral blood stem cell (PBSC) infusion (MT2001-10).
16168787|NCT01634204|Other|KiloCoach|"Study participants in this arm will use the program to record nutrition and physical activity on at least 4 days per week within the first and ad libitum within the second 3 months of the intervention period.
~Study visits will be conducted at baseline as well as after 1, 3 and 6 months. After 12 months a follow up visit will be conducted."
16168788|NCT01634204|Other|Control|"Study subjects try to reduce their body weight on their own. They are free to exercise and/or change nutritional habits. Not allowed is taking part in any structured weight loss program.
~Study visits will be conducted at baseline as well as after 1,3 and 6 months. A follow up visit will be conducted after 12 months."
16168789|NCT01634191|Drug|Apremilast|One oral 30 mg dose of apremilast
16168790|NCT01634178|Drug|Apremilast|Tablet for oral administration
16168791|NCT01634165|Drug|LY2963016|Administered subcutaneously
16168792|NCT01634165|Drug|Lantus|Administered subcutaneously
16168793|NCT01634152|Drug|Placebo|2 actuations once daily in the evening
16168794|NCT01634152|Drug|Tiotropium low dose mcg|2 actuations once daily in the evening
16168795|NCT01634152|Drug|Tiotropium high dose|2 actuations once daily in the evening
16168796|NCT01634139|Drug|Tiotropium low dose QD|2 actuations once daily in the evening
16168797|NCT01634139|Drug|Tiotropium high dose QD|2 actuations once daily in the evening
16168798|NCT01634139|Drug|Placebo|2 actuations once daily in the evening
16168799|NCT01634126|Behavioral|1 FIT kit|Patient receives 1 FIT
16168800|NCT01634126|Behavioral|2 FIT kit|Patient receives 2 FIT kits
16168801|NCT01634113|Drug|tiotropium-bromide|IMP
16168802|NCT01634113|Drug|tiotropium-bromide|IMP
16168803|NCT01634113|Drug|placebo|placebo matching tiotropium
16168804|NCT01634100|Drug|Probenecid|Probenecid
16168805|NCT01634100|Drug|Rifampicin|Rifampicin
16168806|NCT01634100|Drug|Empagliflozin|BI Drug
16168807|NCT01634100|Drug|Empagliflozin|BI Drug
16168808|NCT01634100|Drug|Rifampicin|Rifampicin
16168809|NCT01634100|Drug|Probenecid|Probenecid
16168810|NCT01634100|Drug|Empagliflozin (BI 10773)|BI Drug
16168811|NCT01634087|Drug|Itacitinib|Itacitinib administered orally
16168812|NCT01634087|Drug|Placebo|Placebo administered orally
16168813|NCT01634061|Drug|BEZ235|BEZ235 will be supplied as 50mg, 100mg, 200mg, 300mg and 400mg SDS sachets. At each patient's visit, patient will reecive a prescription of an adequate drug supply for self administration at home.
16168814|NCT01634061|Drug|BKM120|BKM120 will be supplied as 10mg and 50mg hard gelatin capsules. At each patient's visit, patient will reecive a prescription of an adequate drug supply for self administration at home.
16168815|NCT01634061|Drug|BEZ235|BEZ235 will be supplied as 50mg, 100mg, 200mg, 300mg and 400mg SDS sachets. At each patient's visit, patient will reecive a prescription of an adequate drug supply for self administration at home.
16168816|NCT01634061|Drug|BKM120|BKM120 will be supplied as 10mg and 50mg hard gelatin capsules. At each patient's visit, patient will reecive a prescription of an adequate drug supply for self administration at home.
16168817|NCT01634048|Dietary Supplement|High Protein, low calorie meal replacement|The high protein group will have meal replacements with added protein powder (to achieve 1.34g protein/kg body weight) and the control group will have standard meal replacements (0.8g protein/kg body weight). Meal replacements have been used in hundreds of previous human studies and are generally not found to be linked to any serious adverse effects.
16168818|NCT01634022|Procedure|Acupuncture|5 specific body acupoints (HT-7 and LI-4 on the hands bilaterally, and ST-36, SP-6, and LR-3 on the legs bilaterally) with gentle manual tonification every 10 min. Two acupoints along the midline of the head, GV-20 and GV-24.5 (Yintang), were also used with a 2 Hz current applied from GV-20 (-) to GV24.5 (+).
16168819|NCT01634009|Dietary Supplement|Soy-based RUTF (in double blind design)|Soy-based RUTF will be given in double blind manner
16168820|NCT01633996|Procedure|Acupuncture|Our acupuncture treatment protocol included: HT-7 and LI-4 on the hands bilaterally, and ST-36, SP-6, and LR-3 on the legs bilaterally, with gentle manual tonification every 10 minutes; and GV-20 and GV- 24.5 (Yintang), along the midline of the head.
16168821|NCT01633983|Drug|Methotrexate|7.5 mg per week p.o. escalating up to 15 mg per week
16168822|NCT01633983|Drug|Delayed treatment|Methotrexate 7.5 mg per week per os escalating to 15 mg per week
16168823|NCT01633970|Drug|5-FU|Participants will receive 5-FU 400 mg/m^2 IV q2w.
16168824|NCT01633970|Drug|Atezolizumab|Participants will receive IV atezolizumab (800 mg q2w or 1200 mg q3w) q3w.
16168825|NCT01633970|Drug|Bevacizumab|Participants will receive bevacizumab 10 mg/kg or 15 mg/kg IV q3w.
16168826|NCT01633970|Drug|Carboplatin|Participants will receive carboplatin IV q3w with target AUC of 6 mg/mL.
16168827|NCT01633970|Drug|Leucovorin|Participants will receive leucovorin 400 mg/m^2 IV q2w.
16168828|NCT01633970|Drug|Nab-paclitaxel|Participants will receive nab-paclitaxel 100 mg/m^2 IV qw.
16168829|NCT01633970|Drug|Oxaliplatin|Participants will receive oxaliplatin 85 mg/m^2 IV q2w.
16168830|NCT01633970|Drug|Paclitaxel|Participants will receive paclitaxel 200 mg/m^2 IV q3w.
16168831|NCT01633970|Drug|Pemetrexed|Participants will receive pemetrexed 500 mg/m^2 IV q3w.
16168832|NCT01633957|Other|Genotype-based Warfarin Initiation model|Based on previous retrospective study,investigators established a genotype-based warfarin model to estimate the drug dosage.
16168833|NCT01633957|Other|clinical factor-based warfarin initiation model|Based on previous retrospective study,investigators established a clinical factor-based warfarin model to estimate the drug dosage.
16168834|NCT01633944|Drug|Buprenorphine|Buprenorphine HCl Buccal Film at doses ranging from 75-600 mcg twice daily
16168835|NCT01633944|Drug|Placebo|Matching Placebo Buccal Film twice daily
16168836|NCT01633918|Behavioral|Internet-supported FeetEnergy approach|Three health education lessons and two homework's about increasing physical activity and reducing screen time
16168837|NCT01633918|Behavioral|Usual health education|Usual health education lessons
16168838|NCT01633892|Procedure|Fat Grafting|
16168839|NCT01633879|Behavioral|audio-CD parent education|audio CD stories in English and Spanish that support positive parenting practices
16168840|NCT01633879|Behavioral|health and success parent and school|Parenting education and school intervention
16168841|NCT01633853|Drug|Vitamin D2|Treatment with Vit D2.
16168842|NCT01633853|Drug|1,25(OH)2 Vit D3|Treatment with 1,25(OH)2 Vitamin D3(Rocaltrol).
16168843|NCT01633840|Other|Elemental E028 with added food allergens|Test materials containing liquid vehicle (Elemental E028)with added food allergens (active)
16168844|NCT01633840|Other|Elemental E028|Elemental E028 with no added food allergens
16168845|NCT01633827|Drug|Placebo pill|Subjects will receive a sugar pill (in combination with room air) during their placebo arm studies
16168846|NCT01633827|Drug|Sedative|Subjects will receive eszopiclone (in combination with medical oxygen) during their treatment arm studies
16168847|NCT01633827|Other|Room air|Subjects will receive room air (in combination with a sugar pill) during their placebo arm studies
16168848|NCT01633827|Other|Oxygen|Subjects will receive medical grade oxygen (in combination with eszopiclone) during their treatment arm studies
16168849|NCT01633814|Drug|Transdermal estradiol|transdermal estradiol, delivery rate 100 µg day-1
16168850|NCT01633814|Drug|Placebo|placebo patch.
16168851|NCT01633801|Device|Use of high flows versus oxygen therapy|Once extubation has taken place the child will be placed either on traditional oxygen therapy or high flow nasal cannulae according to randomization.
16168852|NCT01633801|Device|oxygen therapy|Once extubation has taken place the child will be placed either on traditional oxygen therapy or high flow nasal cannulae according to randomization.
16168853|NCT01633788|Drug|AGN-195263 0.1%|1 drop of AGN-195263 0.1% instilled in each eye twice daily.
16168854|NCT01633788|Drug|AGN-195263 0.03%|1 drop of AGN-195263 0.03% instilled in each eye twice daily.
16168855|NCT01633788|Drug|AGN-195263 0.01%|1 drop of AGN-195263 0.01% instilled in each eye twice daily.
16168856|NCT01633788|Drug|AGN-195263 Vehicle|1 drop of AGN-195263 vehicle (placebo) instilled in each eye twice daily.
16168857|NCT01633775|Procedure|Implantation of Ahmed glaucoma tube shunt, and Trabeculectomy with MMC|In the Ahmed implant group, the tube shunts used were the valved 184-mm2 surface area (Model FP7; New World Medical, Inc, Rancho Cucamonga, California, USA). In the Trabeculectomy group, a routine trabeculectomy surgery was performed.
16168858|NCT01633762|Drug|meropenem, gentamicin, vancomycin (together)|"4 days antibiotic treatment, per oral, once daily: vancomycin 500 mg (Vancomycin Hospira), powder for concentrate; gentamycin 40 mg (Hexamycin®), solution; meropenem 500 mg (Meropenem Hospira), powder for concentrate; The three drugs are dissolved and combined to a cocktail (with approximately 100 ml of apple juice)"
16168859|NCT01633749|Biological|Trivalent influenza subunit vaccine Influvac|3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1
16168860|NCT01633736|Other|Usual care plus progresive resistance training|Duration 8 weeks; two weeks of familiarisation with the intervention protocol without resistance (for familiarisation and neural adaptation) followed by 6 weeks progressive resistance (PR). The three times a week PR training will be as a home exercise program with fortnightly home visits to monitor/progress PR training. It comprises a 4 minute warm up and cool down with one exercise targeting the hip abductors and one the lateral rotators. Exercise prescription will follow existing guidelines for progressive PR training. Parents will be taught supervision by the researcher using clear explanations in words and pictures in a logbook. Logbooks have been found to facilitate compliance, dosage and motivation.
16168861|NCT01633723|Drug|DA-6886|"single dose study : DA-6886 1mg,2.5mg,5mg,10mg,20mg dosage (Dose-escalation)
~multiple dose study : DA-6886 2.5mg,5mg,10mg or 5mg,10mg,20mg dosage (Dose-escalation)"
16168862|NCT01633723|Drug|Placebo of DA-6886|DA-6886 placebo
16168863|NCT01633697|Behavioral|Pranayama|Specific yoga-related breathing method.
16168864|NCT01633697|Behavioral|Education alone|No special attention to breathing
16168865|NCT01633658|Dietary Supplement|cholecalciferol|a single dose of 2500 micrograms of cholecalciferol
16168866|NCT01633658|Dietary Supplement|25(OH)D|a single dose of 625 micrograms of 25(OH)D
16168867|NCT01633645|Drug|Bortezomib|Velcade
16168868|NCT01633645|Drug|Gemcitabine|Gemcitabine 1000 mg/m2 on days 1 and 8 of a 21-days treatment cycle for a maximum of 8 cycles
16168869|NCT01633645|Drug|Cisplatin|Cisplatin 70 mg/m2 on day 1 of a 21-days treatment cycle for a maximum of 8 cycles
16168870|NCT01633632|Behavioral|Hatha yoga|30 minutes of instruction in Hatha yoga will be provided for 8 sessions.
16168871|NCT01633632|Behavioral|Cognitive behavioral therapy|8-sessions of cognitive behavioral therapy will be provided following a standardized curriculum.
16168872|NCT01633593|Drug|Donepezil|5 mg PO a day, during 2 weeks
16168873|NCT01633580|Drug|corifollitropin alfa|long acting FSH
16168874|NCT01633567|Behavioral|Culturally Targeted Cessation Program|The culturally targeted version of the behavioral counseling intervention will consist of six group-based smoking cessation counseling sessions. Each smoking cessation therapy session will last approximately 90 minutes and will begin two weeks before the quit date. In addition, participants will be provided nicotine replacement therapy and peer support sessions will occur between the group sessions.
16168911|NCT01633177|Drug|Omega-3 fatty acid (fish oil)|Omacor, 1 capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
16168875|NCT01633567|Behavioral|Non-Targeted Cessation Program|Behavioral counseling intervention will consist of six group-based smoking cessation counseling sessions. Each smoking cessation therapy session will last approximately 90 minutes and will begin two weeks before the quit date. In addition, participants will be provided nicotine replacement therapy and peer support sessions will occur between the group sessions.
16168876|NCT01633541|Drug|AT-101|Patients will receive AT-101 40 mg orally two times a day.
16168877|NCT01633541|Drug|Docetaxel|Docetaxel (Taxotere) 75 mg/m2
16168878|NCT01633541|Drug|Cisplatin|Cisplatin 100 mg/m2
16168879|NCT01633541|Drug|Carboplatin|Carboplatin AUC (area under the curve) 6. Maximum dose of 700 mg
16168880|NCT01633528|Drug|Asprin|100 mg
16168881|NCT01633528|Drug|placebo|100mg
16168882|NCT01633515|Procedure|Intralesional cryotherapy|"The Intralesional cryotherapy technology (CryoShape; CryoShape™, U.S Patent Number 6,503,246; European Patent Number 1299043, FDA 510(k) Number K060928) had been developed for the treatment of hypertrophic scars and keloids. The cryoneedle is connected by an adaptor to a cryogun filled with liquid nitrogen, and is introduced into the BCC. After the BCC is completely frozen, the cryoprobe defrosts and is withdrawn.
~Other relevant intervention: The cryotherapy will be performed under local anesthesia (bupivacaine). After the procedure topical antibiotic cream will be applied. Participants will be followed at the out patient clinic for an average duration of 5 month after cryotherapy (3 month post cyotherapy until the biopsy and then 1-2 month more until biopsy results are received)."
16168883|NCT01633502|Device|Conventional circulatory support|Control group treated with conventional circulatory support and observed in intensive care unit for a minimum of 48 hrs.
16168884|NCT01633502|Device|Impella CP|Control group treated with Impella CP for a minimum of 48 hrs.
16168885|NCT01633476|Drug|Valaciclovir|2g q.d.s. orally for 6 months (dose adjusted according to renal function)
16168886|NCT01633450|Other|Zinc biofortified rice|1.12 mg zinc per meal
16168887|NCT01633450|Other|Rice extrinsically fortified with zinc|1.12 mg zinc per meal
16168888|NCT01633437|Drug|CX157|CX157 Modified Release Tablet 125 mg administered twice per day on study days 4-11 and in the morning of study day 12.
16168889|NCT01633437|Other|Placebo|Placebo administered twice per day on study days 4-11 and in the morning of day 12.
16168890|NCT01633411|Device|Focal Cryoballoon Ablation System - 6 seconds|"Ablation of Barrett's Esophagus using a Focal Cryoballoon ablation catheter. The System is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications."
16168891|NCT01633411|Device|Focal Cryoballoon Ablation System - 8 seconds|"Ablation of Barrett's Esophagus using a Focal Cryoballoon ablation catheter. The System is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications."
16168892|NCT01633411|Device|CryoBalloon Focal Ablation System - 10 seconds|"Ablation of Barrett's Esophagus using the Focal CryoBalloon Ablation System. The System is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications."
16168893|NCT01633398|Genetic|Saliva Genetic testing|To compare the genetic variants between the two phenotypes of reduced versus preserved ejection fraction (HFrEF versus HFpEF)
16168894|NCT01633372|Drug|itacitinib|
16168895|NCT01633359|Drug|Intensive statin|the Intensive Atorvastatin protocol indicates that once 80mg Atorvastatin will be administrated before CAG, and then will be followed with 20mg Atorvastatin daily during the entire study period.
16168896|NCT01633359|Drug|Routine statin|the Routine Atorvastatin protocol indicates that 20mg Atorvastatin daily during the entire study period.
16168897|NCT01633333|Other|Water exchange colonoscopy|Water is infused and suctioned in a systematic fashion to obtain luminal view and for cleansing of the colon to facilitate colonoscope insertion. The carbon dioxide pump is turned off, only to be turned on during withdrawal from the cecum.
16168898|NCT01633333|Other|Carbon dioxide insufflation|Carbon dioxide insufflation to obtain luminal view to facilitate colonoscope insertion, considered to be standard procedure.
16168899|NCT01633307|Other|Education|Teaching program
16168900|NCT01633294|Drug|Ampicillin + gentamicin|ampicillin 1 g every six hours and gentamicin 240 mg every day intravenously
16168901|NCT01633281|Procedure|acupuncture|Ten sessions of acupuncture at 2x per week over 5 weeks will be given to patients. The acupuncture points include a standard set of obligatory points and additional points based on symptoms.
16168902|NCT01633255|Drug|18F-Fluciclatide|
16168903|NCT01633229|Procedure|Bone Marrow Stromal Cell Infusion|
16168904|NCT01633216|Biological|Bivalent OPV 2 week interval|Group A will receive 3 doses of bOPV at 6, 8 and 10 weeks of age (2-week interval between doses).
16168905|NCT01633216|Biological|Bivalent OPV 4 week interval|Group B will receive 3 doses of bOPV at 6, 10 and 14 weeks of age (4-week interval between doses).
16168906|NCT01633216|Biological|Monovalent OPV 2 week interval|Group C will receive 3 doses of mOPV1 at 6, 8 and 10 weeks of age (2-week interval between doses).
16168907|NCT01633216|Biological|Monovalent OPV 4 week interval|Group D will receive 3 doses of mOPV1 at 6, 10 and 14 weeks of age (4-week interval between doses).
16168908|NCT01633216|Biological|Trivalent OPV 4 week interval|Group E will receive 3 doses of tOPV at 6, 10 and 14 weeks of age (4-week interval between doses and similar to the current routine immunization schedule).
16168909|NCT01633203|Drug|epirubicin + cisplatin + capecitabine polychemotherapy|"EPIRUBICIN (LKM)at a dose of 50 mg/m2 over 15 minutes is administered every 21 days.
~CISPLATIN (LKM) at a dose of 60 mg/m2 over 4 hours is administered every 21 days. Patients must receive standardized hydration per protocol.
~CAPECITABINE (Xeloda®) at a dose of 625 mg/m2 BID (i.e. 1250 mg/m2/day) 30 minutes after meals from day 1 to day 21 of every cycle of chemotherapy.
~Antiemetic therapy:
~Dexamethasone 8 mg IV and Ondansetron (LKM) 8 mg IV o Granisetron (Kytril®) prior to chemotherapy
~Rescue Ondansetron (LKM) 8 mg IV will be given during 24-hour hospitalization in case of emesis
~Symptomatic antiemetic therapy with thiethylperazine will be prescribed.
~Loperamide will be prescribed in case of diarrhea."
16168910|NCT01633177|Dietary Supplement|Vitamin D3|Vitamin D3 (cholecalciferol), 2000 IU per day.
16168912|NCT01633177|Dietary Supplement|Vitamin D3 placebo|Vitamin D3 placebo
16168913|NCT01633177|Drug|Fish oil placebo|Fish oil placebo
16325513|NCT00457171|Drug|GI-270384|
16168914|NCT01633164|Behavioral|SCI Reinvention Protocol Participants|The intervention involves participation in a six week psychologically-based educational intervention. During the course, 8 specific skills are reviewed in order to specifically address reframing a person's method of looking at events, build confidence by focusing on personal strengths, develop methods of recognizing and appreciating the good in one's life and express gratitude for positive attributes. These skills are presented in a specific sequence so that participants can gain mastery of introductory concepts before undertaking those that are both more difficult and complex.
16168915|NCT01633164|Other|Waitlist Group|Wait list arm will begin study intervention after 4 1/2 months.
16168916|NCT01633138|Behavioral|Cognitive Remediation Therapy - Standard|Computerized cognitive remediation therapy provided three times per week for four weeks
16168917|NCT01633138|Behavioral|Cognitive Remediation Therapy plus Contingency Management|Standard cognitive remediation therapy plus monetary incentives based on performance provided three times per week for four weeks.
16168918|NCT01633125|Other|Group music therapy|The academically trained music therapist with previous relevant clinical experience will apply receptive and active music therapy techniques. The receptive methods will include music imagery,The active techniques will include musical improvisation and song writing.
16168919|NCT01633112|Drug|fingolimod|capsule
16168920|NCT01633112|Drug|glatiramer acetate|subcutaneous injection
16168921|NCT01633099|Drug|Decitabine|"Number of Cycles: 4 cycles.
~Dose and drug delivery(decitabine):
~The 1st cycle: 20 mg/m2, (iv,>1 hour) d1-10 of each 28 day cycle. The 2nd-4th cycle:If bone marrow blast cells≥5%, the following cycle is the same as the 1st cycle.
~If bone marrow blast cells<5%, the following cycle:decitabine 20 mg/m2, (iv,>1h) on d1-5 of each 28 day cycle.
~If Grade 4 neutropenia（<0.5×10E9/L）come arise after 5 days' cycle of decitabine and lasts more than 14 days in last cycle,the next cycle will decrease dose to 4 days(20 mg/m2, IV ,>1h, on d1-4 of each 28 day cycle).If Grade 4 neutropenia（<0.5×10E9/L）come arise after 4 days' cycle of decitabine and lasts more than 14 days in last cycle,the next cycle will decrease dose to 3 days(20 mg/m2, IV,>1h, on d1-3 of each 28day cycle)."
16168922|NCT01633086|Drug|nitric oxide gel|"st gel: sodium nitrites,BID local use X 28 days
~nd gel: maleic/ascorbic acids ,BID local use X 28 days"
16168923|NCT01633086|Drug|placebo gel|placebo gel,BID local use X 28 days
16168924|NCT01633073|Device|LMA Supreme: control device|LMA Supreme will be placed in children weighing 5-50kg based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, 2.5, or 3.0. The size of the airway device will be determined according to the manufacturer's guidelines that are standardized by the patient's weight in kilograms.
16168925|NCT01633073|Device|i-gel: comparison device|i-gel will be placed in children weighing 5-50kg based on a computer generated randomization. One of four different sizes of airways will be used: 1.5, 2.0, 2.5, or 3.0. The size of the airway device will be determined according to the manufacturer's guidelines that are standardized by the patient's weight in kilograms.
16168926|NCT01633060|Drug|Fulvestrant|Intramuscular fulvestrant 500 mg (Day 1 and Day 15 of Cycle 1 and Day 1 of every cycle thereafter)
16168927|NCT01633060|Drug|BKM120|BKM120 100 mg once daily
16168928|NCT01633060|Drug|BKM120 matching placebo|BKM120 matching placebo, once daily
16168929|NCT01633047|Other|electrical stimulation|Intervention group that will be submitted to physical therapy exercises plus electrical stimulation (low frequency device with a current of 47 Hz with symmetrical, biphasic and pyramidal waveforms, with pulse duration of 1.5 s and interval of 1.8 s)
16168930|NCT01633047|Other|physical therapy exercises|Control group that will be submitted only to physical therapy exercises
16168931|NCT01633008|Behavioral|ACT Workshop|The ACT workshops will consist of a patient program and a corresponding parent program, each focusing on helping participants cope with the patient s pain more effectively using ACT techniques
16168932|NCT01632995|Drug|FTC 200 mg/TDF 300 mg fixed-dose combination tablet|Each participant will be directed to take one FTC/TDF tablet orally once a day, with or without food.
16168933|NCT01632982|Behavioral|standard treatment|the standard drug counseling offered to patients at the study site's methadone maintenance program
16168934|NCT01632982|Behavioral|MTS (Mobile Therapeutic System)|a novel, interactive, mobile phone-delivered psychosocial intervention designed to promote skills acquisition and reduce drug use among adults in methadone maintenance treatment
16168935|NCT01632982|Behavioral|mobile control|a mobile phone-based application that directs participants to the NIDA website's homepage
16168936|NCT01632969|Behavioral|The The Family Assessment of Treatment at the End of life (FATE ) survey|Study candidates will be contacted by mail with an initial contact letter with information explaining the study, and then will receive a follow-up phone call to discuss their participation in the study no later than 1 month following the posting of the initial contact letter. If a family member or next-of-kin chooses to participate, verbal informed consent will be obtained over the phone and a one-time telephone interview will be conducted.
16168937|NCT01632956|Behavioral|in-person support group|Each support group will consist of 12 sessions. Thirty-two breast cancer patients of Chinese descent will be recruited to participate in the support groups (16 in the inperson groups and 16 in the virtual groups).
16168938|NCT01632956|Behavioral|virtual support group|Each support group will consist of 12 sessions. Thirty-two breast cancer patients of Chinese descent will be recruited to participate in the support groups (16 in the inperson groups and 16 in the virtual groups).
16168939|NCT01632943|Device|Symplicity renal denervation system|"Previous research has shown that disrupting the nerves of the kidney may successfully decrease blood pressure.
~A less invasive approach to disrupting these nerves is to apply a brief high temperature near the nerves (renal denervation). This can now be done with an experimental medical device called the Symplicity renal denervation system. The System includes a catheter that is inserted into your blood vessels and an RF-generator."
16168940|NCT01632930|Other|urinary PCA3 test using Progensa® PCA3 assay kit (Gen-Probe)|urinary PCA3 test will be performed in patients before they undergo prostate biopsy for increased serum PSA and/or abnormal digital rectal examination. Patients with negative biopsies will be definitively enrolled in the study. The physician in charge will have knowledge of PCA3 test results and will be asked to determine the subsequent follow-up taking these results into account.
16168941|NCT01632917|Drug|ATX-101 - U.S.|US ATX-101, 10 mg/mL, one dosing session in the submental area
16168942|NCT01632917|Drug|ATX-101 - EU|EU ATX-101, 10 mg/mL, one dosing session in the submental area
16168943|NCT01632904|Drug|Ruxolitinib|Ruxolitinib will be orally self-administered at a starting dose of 10 mg (two 5 mg tablets) twice a day. Dose increases of 5 mg (1 tablet) in twice-daily increments are permitted after 4 weeks and again after 8 weeks of therapy for subjects who meet prespecified criteria for inadequate efficacy.
16168944|NCT01632904|Drug|Hydroxyurea (HU)|Hydroxyurea (500 mg capsules) will be orally self-administered at the dose that the subject was receiving previously. The dose may be increased after 4 weeks and again after 8 weeks of therapy to optimize efficacy for subjects meeting prespecified criteria.
16168945|NCT01632904|Drug|HU-placebo|"All placebo will be self-administered, and dosing will be the same as with the blinded dose.
~When adjustments are made to the ruxolitinib dose, the dose of HU-placebo will be adjusted concurrently."
16168946|NCT01632904|Drug|Ruxolitinib-placebo|"All placebo will be self-administered, and dosing will be the same as with the blinded dose.
~When adjustments are made to the HU dose, the dose of ruxolitinib-placebo will be adjusted concurrently."
16168947|NCT01632891|Drug|Lopinavir/ritonavir|Participants received two 200 mg/50 mg tablets of lopinavir/ritonavir orally twice daily.
16168948|NCT01632891|Drug|Emtricitabine/tenofovir disoproxil fumarate|Participants received one 200 mg/300 mg tablet of Emtricitabine/tenofovir disoproxil fumarate orally once daily.
16168949|NCT01632891|Drug|Efavirenz|Participants received one 600 mg tablet of efavirenz orally once daily.
16168950|NCT01632891|Drug|Nevirapine|If unable to take efavirenz, participants received on 200 mg tablet of nevirapine orally once daily.
16168951|NCT01632891|Drug|Trimethoprim/sulfamethoxazole|Participants received one 160 mg/800 mg tablet of trimethoprim/sulfamethoxazole orally once daily.
16168952|NCT01632865|Device|stenting|Apollo stent (MicroPort Medical, China),Neuroform stent (Stryker/Boston Scientific, USA) or Wingspan stent (Stryker/Boston Scientific, USA), et al.
16168953|NCT01632852|Biological|CSL362|"CSL362 is humanized monoclonal antibody that targets the alpha chain of the interleukin 3 receptor (IL3Rα; also known as CD123) and is optimised for enhanced activation of antibody-dependent cell-mediated cytotoxicity (ADCC) via natural killer cells.
~CSL362 is a sterile solution for injection and will be administered by intravenous infusion to subjects in sequential, escalating dose level cohorts, at doses up to 12.0 mg/kg. CSL362 will be administered every 14 days for a total of 6 infusions per subject. The 6 infusions for each individual subject will contain the same dose of CSL362."
16168954|NCT01632826|Drug|Pomalidomide|4 mg daily for 21 days in a 28 day cycle until disease progression or other reasons for treatment discontinuation
16168955|NCT01632800|Device|High pulsed magnetic fields|Magnetic fields will escalate in strength
16168956|NCT01632787|Other|Questionnaires and Optometrist Prism Challenge/Treatment|A Vertical Heterophoria Symptom Questionnaire (VHSQ) as well as Headache Disability Index (HDI) survey is used on all Emergency Department (ED) headache patients to assess medical history and symptom burden. Prism testing (or Prism Challenge) is performed by the study optometrist to identify those who have Vertical Heterophoria (VH). Prism Challenge is similar to prescription eyeglass testing, but with unique lenses that are meant to reduce strain on eyes that are misaligned. Follow-up questionnaires are then administered to assess any improvement in symptom burden.
16168957|NCT01632761|Dietary Supplement|Vitamin D3 .|
16168958|NCT01632761|Drug|omega-3 fatty acids (fish oil)|
16168959|NCT01632761|Dietary Supplement|Vitamin D3 placebo|
16168960|NCT01632761|Dietary Supplement|Fish oil placebo|
16168961|NCT01632748|Device|Neurotech Vital Device|5 minute treatment
16168962|NCT01632748|Device|Modified Neurotech Vital Device|5 minute stimulation
16168963|NCT01632735|Behavioral|Mobile Continuing Care|Behavioral: Mobile Texting 12-week intervention. Delivers daily Recovering monitoring, self-management feedback, and education/social support
16168964|NCT01632722|Drug|Bevacizumab, mFOLFOX, FOLFIRI|"ArmA (postoperative arm)
~Postoperative mFOLFOX or FOLFIRI regimen, every 2weeks for 12cycles Bevacizumab 5mg/kg IV, every 2weeks for 11cycles beginning with cycle 2"
16168965|NCT01632722|Drug|Bevacizumab, mFOLFOX, FOLFIRI|"ArmB (perioperative arm)
~Perioperative CTx mFOLFOX or FOFIRI regimen, every 2 weeks for 6 cycles Bevacizumab 5mg/kg IV, every 2 weeks for 5cycles (cycles 1-5)
~Postoperative CTx mFOLFOX or FOLFIRI regimen, every 2weeks for 6 cycles Bevacizumab 5mg/kg IV, every 2weeks for 5cycles(cycles 8-12)"
16168966|NCT01632709|Drug|Bupivacaine|one injection of 10ml of .25%
16168967|NCT01632709|Drug|Placebo|Dry needling
16168968|NCT01632696|Drug|I-124 PGN650 for PET/CT|I-124 PGN650 for PET/CT Day 1, Day 2 and 3.
16168969|NCT01632683|Device|C-MAC|C-MAC arm
16168970|NCT01632683|Device|Glidescope|Glidescope arm
16168971|NCT01632670|Other|Music therapy|The music played will be by MusiCure, by Niels Eje (slow, relaxing music designed for therapeutic use), and will be played from an audio pillow beneath the patient's head.
16168972|NCT01632657|Drug|Sumatriptan|Single subcutaneous injection sumatriptan 6mg (in 0.5ml) in recovery
16168973|NCT01632657|Other|Placebo|Single injection saline 0.5ml subcutaneously in recovery
16168974|NCT01632644|Other|Survey/Interview|Each group will be surveyed and interviewed.
16168975|NCT01632618|Behavioral|Trunk Muscle Training+NMES|Progressive exercise program for the stabilizing muscles of the trunk, as well as neuromuscular electrical stimulation to the lumbar paraspinals
16168976|NCT01632618|Behavioral|Passive control intervention|Passive physical therapy approach to low back pain
16168977|NCT01632605|Drug|Sirolimus|Coated tablets, 1mg and 2mg available. Daily oral single dose with trough levels of 4-8ng/mL. Total intake for 6 months.
16168978|NCT01632592|Drug|Tesamorelin|The Growth Hormone Releasing Hormone analogue tesamorelin, 2mg subcutaneously daily by injection
16168979|NCT01632592|Drug|Placebo|placebo given by injection 2mg subcutaneously daily
16168980|NCT01632579|Drug|LY3023703|Administered orally
16168981|NCT01632579|Drug|Placebo|Administered orally
16168982|NCT01632579|Drug|Celecoxib|Administered orally
16168983|NCT01632566|Drug|Placebo|Capsules administered orally
16168984|NCT01632566|Drug|LY3031207|Administered orally
16168985|NCT01632566|Drug|Celecoxib|Administered orally
16168986|NCT01632566|Drug|Simvastatin|Administered orally
16168987|NCT01632540|Drug|Beclomethasone Dipropionate (BDP) Nasal Aerosol|BDP nasal aerosol 320 mcg/day will be administered to all patients as 2 sprays in each nostril once daily.
16170392|NCT01621178|Drug|Insulin glargine|Administered SC
16168988|NCT01632527|Drug|HuCNS-SC cells|HuCNS-SC cells transplantation directly into the subretinal space of one eye (Study eye) in a single transplant procedure.
16168989|NCT01632514|Drug|Cholecalciferol|100,000 U of cholecalciferol weekly for 4 weeks
16168990|NCT01632501|Device|Coronary stent - Tsunami|A coronary angioplasty was done
16168991|NCT01632475|Biological|Pneumostem®|"A single intratracheal administration
~Low Dose Group (3 patients): 1.0 x 10^7 cells/kg, High Dose Group (6 patients): 2 x 10^7 cells/kg
~* The subjects were administered with Pneumostem® in the earlier part of the phase I study. No drugs/biologics are administered during this part of the study."
16168992|NCT01632462|Drug|VSL#3|"This investigation will be a randomized, double-blind, placebo-controlled, cross-over trial. The study will include 30 children with CD and will be articulated in 6 months as follows. These children will be randomised to a treatment group receiving for 2 months either 1-2 packet containing 900 billion bacteria/day of VSL#3 according to their weight, and a group receiving the placebo drug. Assignment to therapy or placebo will be determined according to a computer-generated randomization scheme.. At the completion of the 8 weeks, a wash-out period of 6 weeks will be done, when no preparation will be administered. Then each patient will be switched to the other group and followed likewise for further 8 weeks."
16168993|NCT01632449|Drug|Test product|Dimethyl Fumarate (BG00012)
16168994|NCT01632449|Drug|Reference product|Dimethyl Fumarate (BG00012)
16168995|NCT01632436|Drug|Pixantrone|Experimental Drug
16168996|NCT01632423|Drug|bimatoprost 0.01%|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
16168997|NCT01632397|Behavioral|CBT-based counseling|Cognitive Behavior Therapy for PrEP adherence
16168998|NCT01632397|Behavioral|Health education and supportive counseling|Time matched general supportive therapy of the type commonly available from community therapists.
16168999|NCT01632384|Behavioral|Abstain from smoking for 24 hours|Compare smoking satiation to 24 hour smoking abstinence
16169000|NCT01632371|Device|Paclitaxel Eluting Balloon + Scoring Balloon|Scoring/cutting balloon lesion predilation; paclitaxel eluting balloon therapy
16169001|NCT01632371|Device|Paclitaxel Eluting Balloon|Standard balloon lesion predilation; paclitaxel-eluting balloon therapy
16169002|NCT01632358|Drug|TAP311 capsules|
16169003|NCT01632358|Drug|Placebo|
16169004|NCT01632345|Drug|Doravirine|Part I: Doravirine 25 mg, 50 mg (25 mg X 2), 100 mg, or 200 mg (100 mg X 2) depending upon randomization, taken orally every morning with or without food for at least 24 weeks. Part II: Selected dose of doravirine depending upon randomization (either 25 mg, 50 mg, 100 mg, or 200 mg) tablet orally every morning with or without food for 96 weeks.
16169005|NCT01632345|Drug|Efavirenz|Efavirenz 600 mg tablet orally at bedtime taken without food on an empty stomach for 96 weeks
16169006|NCT01632345|Drug|TRUVADA®|Open-label TRUVADA® (fixed combination 200 mg emtricitabine and 300 mg tenofovir disoproxil fumarate) tablet taken orally with food in the morning for 96 weeks
16169007|NCT01632345|Drug|Placebo for Doravirine|Placebo tablets matching doravirine
16169008|NCT01632345|Drug|Placebo for Efavirenz|Placebo tablets matching efavirenz
16169009|NCT01632332|Biological|HER-2/neu peptide vaccine|Given ID
16169010|NCT01632332|Other|laboratory biomarker analysis|Correlative studies
16169011|NCT01632319|Behavioral|Combined Motivational Interviewing and Cognitive Behavioral Therapy|"8 sessions with study clinician, which focus on depressive symptom treatment and alcohol use Both courses teach coping skills for depression (CBT). However, one course focuses only on treatment for depression whereas the other provides also information tailored to the students' level of drinking and experience with regard to alcohol use.
~In one course students are asked questions about their drinking, receive personalized feedback about it and are taught coping skills for their depressive symptoms"
16169012|NCT01632319|Behavioral|Cognitive Behavioral Therapy|Cognitive behavioral therapy is a type of therapy in which students will be taught coping skills for their depressive symptoms but they may or may not talk about alcohol consumption depending on the students' preference.
16169013|NCT01632306|Drug|LY2090314|LY2090314 administered IV
16169014|NCT01632306|Drug|FOLFOX|FOLFOX administered IV
16169015|NCT01632306|Drug|Gemcitabine|Gemcitabine administered IV
16169016|NCT01632306|Drug|Nab-paclitaxel|Nab-paclitaxel administered IV
16169017|NCT01632293|Behavioral|progressive resistance training|The exercise program uses guided progressive resistance training to provide an individualized program of strength training. The progressive resistance training intervention will consist of 12 weeks of guided resistance training twice weekly; in addition, subjects will be instructed to do one day of progressive resistance training at the home weekly.
16169018|NCT01632280|Device|Transcranial Direct Current Stimulation (tDCS)|"tDCS is a well-established, safe and noninvasive neuromodulation technique that is based on the application of a weak direct current to the scalp that flows between two electrodes-anode and cathode. Although there is substantial shunting of current in the scalp, sufficient current penetrates the brain to modify the transmembrane neuronal potential, and thus influence the level of excitability and modulate the firing rate of individual neurons.
~In this study, participants will receive 10 daily sessions of tDCS (sham/real) over a period of two weeks."
16169019|NCT01632241|Biological|Placebo plus standard therapy|Placebo plus standard therapy
16169020|NCT01632241|Biological|Belimumab 10 mg/kg plus standard therapy|Belimumab 10mg/kg plus standard therapy
16169021|NCT01632241|Drug|Standard therapy|Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; biologics and intravenous cyclophosphamide are not permitted.
16169022|NCT01632228|Drug|Bevacizumab|Participants will receive bevacizumab 15 milligrams per kilogram (mg/kg) IV infusion every 3 weeks until disease progression, unacceptable toxicity, participants or physician decision to discontinue, or death.
16169023|NCT01632228|Drug|Onartuzumab|Participants will receive onartuzumab 15 mg/kg IV infusion every 3 weeks until disease progression, unacceptable toxicity, participants or physician decision to discontinue, or death.
16169024|NCT01632228|Drug|Placebo|Participants will receive placebo matched with onartuzumab until disease progression, unacceptable toxicity, participants or physician decision to discontinue, or death.
16169025|NCT01632215|Drug|Gabapentine|Gabapentine 600 mg 01 dose
16169026|NCT01632215|Other|Sugar pill|Sugar pill 01 dose
16169027|NCT01632202|Device|Seprafilm|Seprafilm Adhesion Barrier (membrane) is a sterile, bioresorbable, translucent adhesion barrier composed of two anionic polysaccharides, sodium hyaluronate (HA) and carboxymethylcellulose (CMC). Together, these biopolymers have been chemically modified with the activating agent 1-(3-dimethylaminopropyl) -3- ethylcarbodiimide hydrochloride (EDC).
16169028|NCT01632202|Device|Sterile Saline Solution|For those randomized not to receive Seprafilm slurry, a syringe will be filled with 25ml of sterile saline.
16169029|NCT01632189|Drug|Varenicline|Varenicline will be administered as prescribed: 0.5 mg for the first 3 days then 1 mg for the next 7 days and 2 mg after that. A quit date will be chosen at 11 days after starting Varenicline. Varenicline will be given for 3 months.
16169030|NCT01632176|Behavioral|Brief, motivational interview and one booster session|This is a one session brief motivational interview-style intervention that follows a 9-step intervention algorithm. The intervention is delivered by a trained motivational interview interventionist. There is one booster call 10 days after the intervention/
16169031|NCT01632163|Drug|Lixisenatide (AVE0010)|"Pharmaceutical form:solution
~Route of administration: subcutaneous injection"
16169032|NCT01632163|Drug|Placebo|"Pharmaceutical form:solution
~Route of administration: subcutaneous injection"
16169033|NCT01632150|Biological|Elotuzumab|Powder for solution, 400-mg vials, for infusion
16169034|NCT01632150|Biological|Thalidomide|50-mg capsules administered orally
16169035|NCT01632150|Biological|Dexamethasone|2- and 4-mg tablets (and various other strengths, as needed) administered orally and in 4- and 8-mg/mL (and various other strengths, as needed) solutions for intravenous administration
16169036|NCT01632150|Biological|Cyclophosphamide|50-mg tablets administered orally
16169037|NCT01632137|Drug|Rebamipide 2% ophthalmic suspension|Instill one drop into each eye 4 times a day for 4 weeks.
16169038|NCT01632137|Drug|Placebo (vehicle)|Instill one drop into each eye 4 times a day for 4 weeks.
16169039|NCT01632124|Other|Lung function measurement|Spirometry and measurement of diffusing capacity for carbon monoxide
16169040|NCT01632111|Other|Lung function measurement|Spirometry
16169041|NCT01632085|Device|The two groups SU and R are defined by the device with which intubation is performed after a first laryngoscopy done with the other device.|"Group SU (Single Use or Laryngobloc ®): the first laryngoscopy is performed with the R and the second laryngoscopy and the intubation is performed with the Laryngobloc ®.
~Group R (Reusable handle+ disposable metal blade): the first laryngoscopy is performed with the Laryngobloc ® and the second laryngoscopy and the intubation is performed with the R."
16169042|NCT01632072|Dietary Supplement|Nutritional support|Nutritional support and counseling
16169043|NCT01632046|Drug|lactate and bicarbonate buffered dialysis solutions|Either PD-solution will be applied. Number of cycles and glucose concentration will be varied according to clinical needs. Sleep Safe system will be used and connected to Sleep Safe Cyclers in patient on CCPD.
16169044|NCT01632020|Drug|Placebo|2 capsules by mouth twice daily; minimum of 10 days, maximum of 21 days
16169045|NCT01632020|Drug|Metformin|850 mg (2 capsules) by mouth twice daily; minimum of 10 days, maximum of 21 days
16169046|NCT01632007|Drug|SYR-472|
16169047|NCT01632007|Drug|Alogliptin 25 mg|
16169048|NCT01632007|Drug|Placebo|
16169049|NCT01631994|Drug|metoclopramide|1 tablet of 10mg of oral dissolving metoclopramide will be taken by patient 45 minutes prior to ingestion of the capsule.
16169050|NCT01631981|Drug|PGL2001 + Primolut-Nor 5|"PGL2001(estradiol sulfamate, E2MATE, ZK190628), Tablets, 1mg. 4 mg weekly for 4 weeks followed by 2mg weekly for 12 weeks.
~Norethisterone acetate (NETA), Tablets, 5mg. Once daily for 16 weeks plus during follow-up."
16169051|NCT01631981|Drug|Placebo + Primolut-Nor 5|"Placebo, Tablets.4 tablets weekly for 4 weeks followed by 2 tablets weekly for 12 weeks.
~Norethisterone acetate (NETA), Tablets, 5mg.Once daily for 16 weeks plus during follow-up."
16169052|NCT01631968|Procedure|Cement without antibiotic.|
16169053|NCT01631968|Procedure|Cement with erytromycin and colistin.|
16169054|NCT01631955|Drug|Ciprobay|Ciprobay (250mg, bid, oral)
16169055|NCT01631942|Drug|NNC172-2021|"Administered as subcutaneous (s.c., under the skin) injections every other day for two weeks.
~Escalation to next dose level is based on a safety evaluation."
16169056|NCT01631929|Other|One bag|Infusion of dextrose and electrolytes using one bag
16169057|NCT01631929|Other|Two bags|Using 2 bags with different solutions with the same electrolyte content but different dextrose concentration (0% and 10%), administered simultaneously through the same intravenous line.
16169058|NCT01631916|Drug|corticosteroid|Dexamethasone 0.6 mg/kg/day or Methylprednisone 1 mg/kg/day
16169059|NCT01631903|Drug|telepristone acetate 12 mg|12 mg, vaginal capsule, once daily for 4 months
16169060|NCT01631903|Drug|telepristone acetate 3 mg|3 mg, vaginal capsule, once daily for 3 months
16169061|NCT01631903|Drug|telepristone acetate 6 mg|6 mg, vaginal capsule, once daily for 3 months
16169062|NCT01631903|Drug|telepristone acetate 12 mg|12 mg, vaginal capsule, once daily, for 3 months
16169063|NCT01631903|Drug|telepristone acetate 24 mg|24 mg, vaginal capsule, once daily for 4 months
16169064|NCT01631890|Procedure|Endoscopic Ultrasound assisted endoscopic glue injection|N Butyl cyanoacrylate will be used for achieving initial hemostasis during active gastric variceal bleed and during follow up gastric variceal obturation. Endoscopic injection will be performed intravariceally using a therapeutic endoscope and a steel hubbed catheter, with N-butyl-2-cyanoacrylate. The cyanoacrylate will be injected without dilution with lipiodol. The tip of the endoscope will be coated with lipiodol to prevent sticking of glue to the endoscope. The injection catheter is primed with saline solution followed by injection of glue in 1ml aliquot to fill the dead space followed by injection of sterile water to flush the glue into the varix. The needle is withdrawn immediately after the glue injection to prevent tissue adherence.
16169065|NCT01631890|Procedure|Standard Endotherapy|Patients will be stabilized by giving i/v fluids, blood and blood products. Injection terlipressin will be given to all patients in a bolus dose of 2mg within 30 minutes of admission to the hospital. This would be followed by 1mg i/v 6hrly and will be continued for 5 days. If terlipressin cannot given then inj.somatostatin 500mcg IV bolus followed by 250mcg/hr continuous infusion for 5days.
16169066|NCT01631877|Drug|Enoxaparin with acenocoumarol|enoxaparin 100mcg/kg for 5days along with acenocoumarol 2mg to start with and dose to be adjusted for the target INR
16170393|NCT01621178|Drug|Insulin lispro|Administered SC
16169067|NCT01631877|Other|placebo|injection placebo will be given for 5 days along with placebo tablets
16169068|NCT01631864|Drug|LCZ696|LCZ696 was provided as 400 mg tablets.
16169069|NCT01631864|Drug|amlodipine|amlodipine was provided as 5 mg tablets.
16169070|NCT01631864|Drug|Placebo|Matching placebo to LCZ696 and amlodipine.
16169071|NCT01631851|Behavioral|Cognitive-Behavioral Therapy (CBT) for Irritability|CBT is an individually administered behavioral interventions aimed at reducing irritability and disruptive behavior. There are 10 to 12 weekly sessions that are conducted with the child and the parent. During these sessions children are taught to recognize antecedents and consequences of problem behavior and to use emotion regulation and problem-solving skills to reduce irritability, aggression and noncompliance.
16169072|NCT01631838|Dietary Supplement|Tocotrienol-rich fraction 400mg|Tocovid Suprabio 200mg is taken twice daily (after breakfast and dinner) for 2 weeks. During postprandial day (Day 14), subjects are requested to consume breakfast meal containing 50g of fat and 100mL of milkshake, follow by capsule consumption
16169073|NCT01631838|Dietary Supplement|Placebo|Placebo is taken twice daily (after breakfast and dinner) for 2 weeks. During postprandial day (Day 14), subjects are requested to consume breakfast meal containing 50g of fat and 100mL of milkshake, follow by capsule consumption
16169074|NCT01631825|Drug|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
16169075|NCT01631812|Drug|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
16169076|NCT01631799|Device|Femoral catheter|Femoral catheter was inserted at the beginning of surgery. After surgery ropivacaine was administered continuously for three days. In addition, patients received piritramide via patient-controlled analgesia. The amount of ropivacaine was measured.
16169077|NCT01631799|Device|Epidural catheter|The epidural catheter was inserted at the beiginning of surgery. After surgery ropivacaine was applied continuously for three days. In addition, patients received piritramide via patient controlled analgesia. The amount of ropivacaine was measured.
16169078|NCT01631773|Genetic|microRNA|Biological samples will be taken from subjects w/ Nasal polyps & AERD disease and subjects w/ nasal polyps without AERD. MicroRNA will be analyzed to compare genetic similarities and differences between the two study groups.
16169079|NCT01631760|Genetic|no intervention|We will be analyzing MicroRNA in subjects with Asthma Exacerbations by various age groups, Ages 5-12yrs, 13-55yrs, and 56-85yrs for genetic similarities and differences.
16169080|NCT01631747|Behavioral|Lifestyle Intervention Group|Moms will meet individually with their Lifestyle Coach (LC)at least 3 times(more as needed, attend six sessions during pregnancy and one session after delivery. In addition moms will participate in monthly phone counseling sessions with Lifestyle Coach and complete daily tracking of diet & activity and use of pedometer
16169081|NCT01631747|Behavioral|Usual Care Group|Mom and family continue their typical eating, activity and other lifestyle habits for 24 months. They are invited to attend quarterly classes addressing prenatal wellness and family topics.
16169082|NCT01631708|Procedure|Erythrocytapheresis|"To achieve a blinded randomised trial, apheresis treatment will be used. Those in arm 1 will have erythrocytapheresis reducing iron levels and those in arm 2 will have plasmapheresis and their iron levels will not be reduced.
~An apheresis machine will be used to remove red blood cells only from the erythrocytapheresis group. Subjects will have third weekly treatments until SF levels are reduced to ~100 ug/L in accordance with current guidelines."
16169083|NCT01631708|Procedure|Plasmapheresis|An apheresis machine will be used to remove blood plasma only from the plasmapheresis group. Those in arm 2 will have the approximate number of episodes of apheresis that would be required to reduce their SF to normal had they been randomised to the true treatment arm. Those in the sham arm will be offered to have venesection at their choice of venue or to have their SF normalised by erythrocytapheresis after the initial blinded part of the study. This will be done because it will not be known for some time if there is benefit from normalisation of SF and therefore leaving people with elevated SF that may be harmful.
16169084|NCT01631682|Drug|Propranolol|40mg single pill
16169085|NCT01631682|Behavioral|Reactivation|subject is re-exposed to CS+R on day 2 (code for CS that is both paired with shock and reactivated on day 2)
16169086|NCT01631682|Drug|Mifepristone|1800mg, 9 tablets
16169087|NCT01631682|Drug|Intranasal oxytocin|32 IU, 8 self-administered intranasal sprays, 4 in each nostril
16169088|NCT01631669|Drug|Celecoxib|200 mg Q 12 hours orally
16169089|NCT01631656|Drug|Azelaic acid|15% gel on half the face, twice daily, 6 weeks
16169090|NCT01631656|Device|Nd:Yag laser|Treatment with Nd:Yag laser , once at Week 2.
16169091|NCT01631643|Device|One Touch VerioIQ Blood Glucose Monitor|BGM with pattern alert technology and with associated pattern guide
16169092|NCT01631630|Drug|Pioglitazone|Pioglitazone is a thiazolidinedione antidiabetic. It works by lowering blood sugar by making the cells of the body more sensitive to the action of insulin.
16169093|NCT01631630|Drug|Placebo|Placebo is an inactive tablet design to look exactly like pioglitazone
16169094|NCT01631617|Drug|Trimethoprim/sulfamethoxazole (TMP/SMZ)|800/160 orally every 12 hours for 14 days
16169095|NCT01631617|Drug|Cephalexin|500 mg orally every 8 hours for 14 days
16169096|NCT01631617|Drug|Doxycycline|20 mg orally every 12 hours for 56 days or 100 mg orally every 12 hours for 56 days
16169097|NCT01631617|Other|Sodium hypochlorite|6 % dilute bleach
16169098|NCT01631617|Other|Placebo capsules|Capsule orally every 8 hours daily for 14 days
16169099|NCT01631617|Other|Placebo Sodium hypochlorite|Three times a week for 14 days
16169100|NCT01631604|Device|Walking aids and devices|Walking aids, e.g. braces, canes,orthoses, prosthetics, etc.
16169101|NCT01631604|Drug|Muscle/nerve injection|Injection to muscle or nerve
16169102|NCT01631604|Procedure|Corrective surgery|correction of spinal and bony deformities, muscle transfer, tendon elongation etc.
16169103|NCT01631604|Other|Physical therapy treatment|
16169104|NCT01631578|Procedure|Injection of an autologous mitochondria to the oocyte.|In the experimental group an autologous mitochondrial concentrate will be injected together with the sperm during ICSI. In the control group conventional ICSI will be performed.
16169105|NCT01631565|Behavioral|Early allocation to palliative care|Symptoms management (e.g. Pain, nausea, dehydration management).
16169106|NCT01631565|Behavioral|Nutritional counseling|Nutritional status evaluation and dietary supplementation according to the patient requirements.
16169107|NCT01631565|Behavioral|Psychoeducation.|Patient and care-taker psychoeducation, depression and anxiety evaluation.
16169108|NCT01631552|Drug|Sacituzumab Govitecan-hziy (SG)|Administered via intravenous (IV) infusion
16169109|NCT01631539|Device|DC Bead™|chemoembolization with DC Bead™ loaded with Irinotecan
16169110|NCT01631539|Drug|Cetuximab|400 mg/m² IV at day 1 followed by 250 mg/m² IV weekly
16169111|NCT01631539|Drug|5 FU|every 2 weeks IV
16169112|NCT01631539|Drug|Irinotecan|every 4 weeks chemoembolization
16169113|NCT01631526|Dietary Supplement|vitamin D|vitamin D3 20,000 IU per day for 14 days followed by 10,000 IU per day for a further 7 days
16169114|NCT01631513|Drug|Nucynta ER|100 to 250 mg every 12 hours
16169115|NCT01631500|Behavioral|Conventional treatment|Conventional treatment
16169116|NCT01631500|Other|Integrative treatment|Person-centred dialogue combined with therapeutic acupuncture (mild manual acupuncture with deqi). Eight individual sessions, once a week, duration approximately 60 minutes
16169117|NCT01631500|Other|Therapeutic acupuncture|Eight individual sessions, once a week, with therapeutic acupuncture. The participants received acupuncture needles in the appropriate acupuncture points, in the same way as the integrative treatment model, but without person-centred dialogue.
16169118|NCT01631487|Drug|JNJ-39439335 10 mg|Multiple (once daily for 21 days) oral doses of JNJ-39439335 10 mg.
16169119|NCT01631487|Drug|JNJ-39439335 25 mg|Multiple (once daily for 21 days) oral doses of JNJ-39439335 25 mg.
16169120|NCT01631487|Drug|JNJ-39439335 50 mg|Multiple (once daily for 21 days) oral doses of JNJ-39439335 50 mg.
16169121|NCT01631487|Drug|Placebo|Multiple (once daily for 21 days) oral doses of matching placebo.
16169122|NCT01631474|Drug|CB-03-01|Topical cream, applied once a day
16169123|NCT01631474|Drug|Vehicle|Topical cream, applied once or twice a day
16169124|NCT01631474|Drug|CB-03-01|Topical cream, applied twice a day
16169125|NCT01631448|Biological|Fibrin Glue|The biological adhesive will be applied to the study group, with the spray technique in two atmospheres of pressure in a total amount of 10 ml.
16169126|NCT01631435|Other|Pillcam colon capsule and PillCam™ Prep Procedure|PillCam® Crhon capsule preparation will include a clear liquid diet and administration of a purgative sulfate-free polyethylene glycol electrolyte lavage (SF-ELS) solution (e.g. Nulytely) divided into two doses: the first dose on the evening before the exam and the 2nd dose on the morning of the exam day.
16169127|NCT01631435|Device|Ileocolonoscopy|"Conventional ileocolonoscopy Examination (same day or within 24 hours)of CE procedure
~• Ileocolonoscopy with intubation of terminal ileum"
16169128|NCT01631422|Drug|RO4602522|Single radiolabeled dose
16169129|NCT01631409|Other|Treatment of CHD risk factors|Smoking cessation, low fat diet, body weight control, physical exercise program, and in some cases lipid-lowering medications, e.g. 3-hydroxy-3-methylglutaric acid-coenzyme A (HMG-CoA) reductase inhibitors, e.g. Simvastatin.
16169130|NCT01631409|Drug|Aspirin, Isosorbide mononitrate, Atenolol, Enalapril.|In the course of optimal medical treatment of Cohort I patient the life style modification is combined with one group of antianginal medications (e.g. Nitrates, Beta-blockers, ACE inhibitors, Calcium antagonists) and lipid-lowering drugs (e.g. HMG-CoA reductase inhibitors).
16169131|NCT01631409|Drug|Aspirin, Isosorbide mononitrate, Atenolol, Enalapril.|In the course of maximal antianginal medical therapy a Cohort II patient is provided with more than one group of antianginal medications (e.g. Nitrates, Beta-blockers, ACE inhibitors, Calcium antagonists) combined with lowering-lipid drugs (e.g. HMG-CoA reductase inhibitors).
16169132|NCT01631409|Procedure|PCA|Percutaneous coronary angioplasty
16169133|NCT01631409|Procedure|CABG|Coronary artery bypass grafting
16169134|NCT01631409|Device|Cardiospec|Cardiac shock wave therapy is implemented by device Cardiospec manufactured by Medispec Ltd.
16169135|NCT01631409|Drug|Aspirin, Isosorbide mononitrate, Atenolol, Enalapril|In the course of maximal antianginal medical therapy a Cohort VI patient is provided with more than two groups of antianginal medications (e.g. Nitrates, Beta-blockers, ACE inhibitors, Calcium antagonists) combined with lowering-lipid drugs (e.g. HMG-CoA reductase inhibitors).
16169136|NCT01631396|Drug|Sugammadex vs. Neostigmine|"Sugammadex Group (n=20) - anesthesia induced by Rocuronium 0.4mg/kg body, additional Rocuronium 0.1-0.2 mg/kg body as needed during surgery (not more than x2), muscular blockage reversal using Sugammadex 2.0 mg/kg body.
~Neostigmine Group (n=20) - anesthesia induced by Rocuronium 0.4mg/kg body, additional Rocuronium 0.1-0.2 mg/kg body as needed during surgery (not more than x2), muscular blockage reversal using Neostigmine 0.05 mg/kg body and atropine 0.1 mg/kg body."
16169137|NCT01631383|Drug|l-THP (l-tetrahydropalmatine)|Subjects will arrive the first day (Day 1) for admission and morning l-THP dosing. The l-THP will be dosed as one capsule 30 mg twice daily (matching placebo or l-THP) (total 60 mg daily). Participants will receive 7 total l-THP doses: two doses on Day 1 (morning and evening), two doses on Day 2 (morning and evening), 2 doses on Day 3 (morning and evening) and one dose the morning of Day 4 (cocaine administration day).
16169138|NCT01631383|Drug|Placebo|Subjects will arrive the first day (Day 1) for admission and morning l-THP dosing. The l-THP will be dosed as one capsule 30 mg twice daily (matching placebo or l-THP) (total 60 mg daily). Participants will receive 7 total l-THP doses: two doses on Day 1 (morning and evening), two doses on Day 2 (morning and evening), 2 doses on Day 3 (morning and evening) and one dose the morning of Day 4 (cocaine administration day).
16169139|NCT01631370|Procedure|Renal denervation|The patients are examined prior to and 6 months after renal denervation. On the day of examination the patients will have blood samples taken and the hyperinsulinemic euglycemic clamp and muscle and adipose tissue biopsies will be performed.
16169140|NCT01631357|Biological|CIK cell|CIK cell injection
16169141|NCT01631357|Drug|Gemcitabine Injection|Gemcitabine injection
16169142|NCT01631357|Drug|Cisplatin injection|Cisplatin injection
16169143|NCT01631344|Other|"Daily physical activity consultation, Using the Stage of change model"|Consultation of daily physical activity is provided, including selection of up to four pain relief exercises
16169144|NCT01631331|Drug|vismodegib|Given PO
16169145|NCT01631331|Procedure|Mohs surgery|Undergo Mohs surgery
16169146|NCT01631318|Procedure|Dynamic contrast-enhanced ultrasound imaging|Ultrasound imaging procedure
16169147|NCT01631318|Device|Optical Tracking Device|Optical Tracking Device, manufactured by Atracsys LLC, Switzerland.
16171945|NCT01608724|Drug|Saxagliptin|oral, 5 mg once a day (Q.D.)
16169148|NCT01631318|Device|Electromagnetic Tracking Device|Electromagnetic Tracking Device, Ascension Technology Corporation, Milton, Vermont.
16169149|NCT01631318|Drug|Perflutren|Perflutren lipid microsphere, IV 0.4 mL. Used as standard contrast agent, not the subject of the study.
16169150|NCT01631305|Drug|Levothyroxine|3 mcg/kg/day
16169151|NCT01631305|Other|Calcium magnesia|Placebo.
16169152|NCT01631292|Dietary Supplement|600 IU Vitamin D3|Once daily
16169153|NCT01631292|Dietary Supplement|2000 IU Vitamin D3|Once daily
16169154|NCT01631292|Dietary Supplement|4000 IU Vitamin D3|Once daily
16169155|NCT01631279|Drug|PR610|Dose escalation of PR610 to determine maximum tolerated dose for weekly administration
16169156|NCT01631266|Biological|C-Tb|The C-Tb agent is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme
16169157|NCT01631266|Biological|2 T.U. Tuberculin PPD RT 23 SSI|The 2 T.U. Tuberculin PPD RT 23 SSI agent is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearm according to a double blind randomisation scheme
16169158|NCT01631253|Procedure|Laparoscopic ovarian cyst enucleation|
16169159|NCT01631227|Drug|Eprosartan|Eprosartan 450 mg
16169160|NCT01631227|Drug|Eprosartan Mesylate|Eprosartan mesylate 600 mg
16169161|NCT01631227|Drug|Placebo Eprosartan mesylate|Placebo Eprosartan mesylate
16169162|NCT01631227|Drug|Placebo Eprosartan|Placebo Eprosartan
16169163|NCT01631214|Biological|Romosozumab|Romosozumab 210 mg administered by subcutaneous injection once a month during the double-blind treatment phase.
16169164|NCT01631214|Drug|Alendronate|Alendronate 70 mg tablet taken once a week
16169165|NCT01631214|Drug|Placebo to Romosozumab|Administered by subcutaneous injection once a month during the double-blind treatment phase.
16169166|NCT01631214|Drug|Placebo to Alendronate|Matching placebo tablet taken once a week during the double-blind treatment phase.
16169167|NCT01631201|Drug|Rifalazil 25 milligram|Single dose of 25 milligram rifalazil to be administered on Day 1.
16169168|NCT01631201|Drug|Azithromycin 1 gram|Single dose of Azithromycin 1 gram to be administered on Day 1.
16169169|NCT01631188|Procedure|Minimally Invasive Aortic Valve|Patients having minimally invasive aortic valve surgery will have a pacing wire placed through the endovent catheter. The anesthesiologist will attempt to pace the ventricle with this wire if needed to wean from bypass.
16169170|NCT01631188|Procedure|Minimally Invasive Aortic Valve Surgery|The Anesthesiologist will advance a pacing wire through the Endovent Catheter under TEE in order to pace the heart when the subject is coming off the Cardiopulmonary bypass machine
16169171|NCT01631188|Device|Manipulation in OR surgical technique|Endovent and pacing wire when coming off cardiopulmonary bypass
16169172|NCT01631175|Behavioral|psychosocial treatment|psychosocial treatment, verbal therapy, relaxation exercises
16169173|NCT01631162|Other|Breath sample in all patients|Breath sample will be collected by a special nylon bag
16169174|NCT01631149|Drug|Surgical block (rocuronium; atracurium/mivacurium)|The surgical block will be varied by either induction of a deep block (via rocuronium infusion) or a moderate/normal block (using atracurium/mivacurium infusion)
16169175|NCT01631149|Drug|Surgical block (rocuronium; atracurium/mivacurium)|A surgical block will be induced by infusion of either rocuronium (deep block) or atracurium/mivacurium (normal/moderate block)
16169176|NCT01631136|Drug|Cisplatin|75 mg/m²
16169177|NCT01631136|Drug|Pemetrexed|500 mg/m²
16169178|NCT01631136|Drug|Cisplatin|80 mg/m²
16169179|NCT01631136|Drug|Gemcitabine|1250 mg/m²
16169180|NCT01631123|Other|Isocaloric high carbohydrate diet intervention|Time of 6 week, the last 6 days are standardized
16169181|NCT01631123|Other|Isocaloric high fat diet intervention|Time of 6 weeks; the first and the last 6 days are standardized
16169182|NCT01631110|Biological|Inflexal V|Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL Inflexal V
16169183|NCT01631097|Drug|Tivozanib hydrochloride|Single oral capsule 1.5 mg tivozanib hydrochloride
16169184|NCT01631084|Other|JADE|"Patients are booked for reviews led by the doctor-nurse-HCA team every 2-4 months, preferably in a setting different from the busy clinics in order to facilitate group education and promote peer support.
~Between each follow-up visit, the nurse or HCA will contact the patient by phone or email to remind them of the appointments (e.g. medical FU visit or laboratory tests), adhere to medications and healthy lifestyles, perform self glucose monitoring and provide psychosocial support, as appropriate."
16169185|NCT01631084|Other|DIAMOND|Patients randomized to the DIAMOND group will receive usual care after the initial baseline comprehensive assessment (CA), with repeat CA at 12 and 24 months.
16169186|NCT01631071|Biological|Virosomal influenza vaccine|Intramuscular administration (M. deltoideus) of a single dose of 0.5 mL virosomal influenza vaccine
16169187|NCT01631058|Drug|Everolimus|"This is a 5-years prospective, randomized, exploratory, single-center, parallel group trial that includes renal transplanted elderly patients (≥ 60 years old) randomized between months 1 and 3 after transplantation to be maintained under MPS/TAC regimen or be switched to EVL/low-TAC.
~Everolimus: initial dose of 1 mg BID. Doses will be adjusted in order to maintain Everolimus whole blood trough concentrations between 3-8 ng/ml.
~Tacrolimus: initial dose of 0.1 mg/kg/day. Doses will be adjusted in order to maintain Tacrolimus whole blood trough concentrations between 2- 4 ng/ml thereafter.
~Corticosteroids: as clinical practice."
16169188|NCT01631032|Drug|Qi-tonifying Chinese herbal products|Chinese herbal products in capsule, 3 times a day, 3gm (6PC of 500mg capsule) each time, total 9gm per day
16169189|NCT01631019|Behavioral|Mobile-phone-based Home Exercise Training Program|Patients in the mobile phone group were asked to perform daily endurance exercise training under mobile phone guidance, and the adherence was reported back to the central server. The level of endurance walking was re-assessed and re-adjusted initially on regular clinical visits every four weeks during the first three months. During this period of time, the adherence to protocol was reinforced by telephone from health professionals whenever patients missed one day of their walking training detected by the central system. Patients were asked to continue their exercise program at home at a fixed walking speed, and return to the clinic at 1, 2, 3 and 6 months.
16169219|NCT01630733|Drug|Custirsen|Custirsen: Three loading doses of custirsen 640 mg IV over 2 hours administered in 5 to 9 days prior to Day 1 of Cycle 1, then custirsen 640 mg IV weekly every 21-day cycle
16169190|NCT01631019|Behavioral|Home Exercise Training Program|all the subjects were assessed by an incremental shuttle walking test (ISWT) (24) for estimation of exercise endurance. Baseline spirometry and body mass index (BMI) were recorded. The adherence and compliance of the home-based exercise training program was assessed by monitoring the frequency of performance and the duration of the endurance walking program recorded on the central system every week. Patients were asked to continue their exercise program at home at a fixed walking speed, and return to the clinic at 1, 2, 3 and 6 months.
16169191|NCT01631006|Device|CPAP|A low or high CPAP pressure is delivered for 20 minutes
16169192|NCT01630993|Other|Umbilical Cord Milking|At birth, the infant will be held below the level of the placenta and umbilical cord will be milked 5 times after birth and before clamping the cord.
16169193|NCT01630980|Other|Tree nuts|Almonds, Brazil nuts, cashews, hazelnuts, macadamia nuts, pecans, pine nuts, pistachios and walnuts in whole, meal, or flour form
16169194|NCT01630967|Drug|Degarelix|Standard dosing and schedule for administration of degarelix will be used. 240mg s.c. loading dose, 80mg s.c. monthly maintenance dose.
16169195|NCT01630954|Procedure|Suction and evacuation|In single evacuation group women will be treated by suction evacuation and curettage is performed at the end of evacuation in one sitting. An ultrasound will be done later to examine completeness of evacuation. If there is significant amount of residual molar tissue or persistence of heavy bleeding a repeat curettage will be done . Women will be followed up with serum beta hcg 1 week after the evacuation and then weekly till the titer is negative. After three consecutive negative titre beat HCG estimation will be done at two weekly interval.
16169196|NCT01630954|Procedure|Suction and evacuation|In double evacuation group , women will be treated by suction evacuation and a thorough curettage will be avoided. A second evacuation with thorough curettage will be performed after 5 - 7 days of first evacuation.
16169197|NCT01630941|Drug|denosumab|Two doses of 60 mg in a solution of 1 ml, given as an subcutaneous injection with a 6 month interval
16169198|NCT01630928|Procedure|Renal sympathetic denervation|This is a mini-invasive trans-catheter procedure with access via a 6F introducer in one of the femoral arteries. The renal sympathetic nerves arise from T10-L2, arborize around the renal artery and primarily lie within the adventitia. A specialized radiofrequency (RF) ablation catheter is introduced into the renal arteries, first one side, then on the other. Usually, 4-6 two-minute treatments per artery using a proprietary RF generator with automated low power and built-in safety algorithms are sufficient to ablate the sympathetic afferent and efferent fibers.
16169199|NCT01630915|Drug|Torrent's Clopidogrel Tablets USP 75 mg|
16169200|NCT01630902|Drug|Torrent's Felodipine Extended-Release Tablets|
16169201|NCT01630889|Drug|Roxadustat|Oral capsule
16169202|NCT01630876|Procedure|Vitrectomy only group|The patients who will underwent 23- gauge transconjunctival sutureless vitrectomy only. The procedure will be done under retrobulbar anesthesia.
16169203|NCT01630876|Procedure|Combined therapy group|The patients who will underwent 23- gauge transconjunctival sutureless vitrectomy with concomitant posterior subtenon Triamcinolone acetate injection. For the posterior subtenon Triamcinolone acetate injection injection, a 1 ml of a 40 mg/ml of triamcinolone acetonide was given in the inferotemporal quadrant using a 27-gauge needle on 3-ml syringe. The conjunctiva and the Tenon's capsule were penetrated with the bevel of the needle toward the globe. The needle was advanced toward the macular area, taking care to remain in contact with the globe until the hub was firmly pressed against the conjunctival fornix and then the corticosteroid was slowly injected.
16169204|NCT01630863|Procedure|Photodynamic therapy|Photodynamic therapy is performed using verteporfin. Full dose of verteporfin is infused for 10 minutes, followed by laser delivery at 15 minutes from the start of infusion. Different light dose of PDT is applied to the patients at 50%, 40% and 30% of the full energy based on TAP study. The area of irradiation is set to the abnormal choroidal vascular hyperpermeability on ICGA corresponding to the leaking area on FA.
16169205|NCT01630850|Biological|Allogenic islet cells (human, U. Chicago)|Human allogenic islet cells. Immunosuppression may include remicade, thymoglobulin,prograf, solu-medrol, and cellcept. Dosage will vary per patient based on weight. Patients will receive immunosuppression medications while islet cells are functioning.
16169206|NCT01630850|Procedure|Intraportal infusion of islet cells|Intraportal infusion of islet cell through the portal vein in the liver.
16169207|NCT01630837|Other|frequency of oral hygiene|the frequency of oral hygiene was 12 to 12 hours, 24 to 24 hours, 48 to 48 hours and 72 to 72 hours.
16169208|NCT01630824|Other|Structured education program|structured education program after kidney transplantation
16169209|NCT01630811|Drug|Nuedexta|Nuedexta (Dextromethorphan hydrobromide 20 mg and quinidine sulfate 10 mg) will be given once daily for 7 days. If well-tolerated, it will be given every 12 hours for the next 7 weeks.
16169210|NCT01630811|Other|Placebo|Placebo will be given once daily for 7 days.
16169211|NCT01630798|Drug|GI heptapeptide|Investigational Agent Name: GI heptapeptide, Linear, 7 amino acid peptide sequence ASYNYDA with a 5-FITC tag and NH2 terminus. Investigational Agent Administration (see SOP in Appendix C) ASYNYDA-GGGSK-(5-FITC)-NH2 0.8 mg lyophilized powder per single-use amber vial Lyophilized powder reconstituted with 5 ml of 0.9% NaCl Final 100 µM concentration for single, one-time topical application Entire 5 ml volume (100 uM concentration) will be sprayed topically onto esophagus by the nurse/physician during the procedure through a standard endoscopy spray catheter (Olympus Medical, Tokyo Japan, PW-5V-1)
16169212|NCT01630785|Device|Intraoperative Neurophysiological Monitoring IONM|Intraoperative Neurophysiological Monitoring IONM device. Manufacturer: Inomed, Emmendingen, Germany
16169213|NCT01630772|Other|Physical therapy|Physical therapy in women with preeclampsia during the hospitalization
16169214|NCT01630772|Other|No physical therapy|Comparison of maternal and fetal hemodynamics in women with preeclampsia who underwent physical therapy and who did not have physical therapy
16169215|NCT01630759|Device|Telemonitoring|Use of telemonitoring facilities to monitor weight, blood pressure and blood sugar during pregnancy complicated by gestational diabetes
16169216|NCT01630759|Other|Control|The control group will receive usual diabetes/antinatal care. The outcomes from usual care will be compared with the outcomes from the telemonitoring group in order to ensure that it provides comparable care.
16169217|NCT01630746|Drug|TAK-438|
16169218|NCT01630746|Drug|TAK-438|
16169220|NCT01630733|Drug|Docetaxel|Docetaxel: 75 mg/m2 IV over 1 hour on Day 1 of every 21-day cycle
16169221|NCT01630720|Dietary Supplement|vitamin C or vitamin D|vitamin C 500 mg twice daily versus vitamin D 5000 IU daily for 7 to 10 days
16169222|NCT01630694|Procedure|3D Laser Scanning of the Head|Five scans will be collected from different angles, each scan taking approximately 3 seconds. Each scan will consist of a thin beam of light flashing of your head.
16169223|NCT01630694|Procedure|Measurements and Digital Photo's of the head, neck and Mouth|Prior to the photographs, certain bone and soft tissue areas such as angle of the jaw, neck and chin will be gently touched and marked with self-adhesive paper stickers. Using the self-adhesive paper stickers and a measuring tape, we obtain measurements of your head and neck. You will be also asked to open your mouth and a digital photograph of the back of the mouth will be taken, as well as, pictures of the front and side of the head and neck.
16169224|NCT01630694|Procedure|Ultrasound Exam of the Tongue|The ultrasound study of the tongue will be performed after the series of laser scans. You will be examined in the sitting position. A small,handheld, curved ultrasound instrument will be placed under the chin to take images of the tongue. This exam should take less than a minute
16169225|NCT01630694|Procedure|3D Laser Scanning of the Head|Five scans will be collected from different angles, each scan taking approximately 3 seconds. Each scan will consist of a thin beam of light flashing of your head.
16169226|NCT01630694|Procedure|Measurements and Digital Photo's of the head, neck and Mouth|Prior to the photographs, certain bone and soft tissue areas such as angle of the jaw, neck and chin will be gently touched and marked with self-adhesive paper stickers. Using the self-adhesive paper stickers and a measuring tape, we obtain measurements of your head and neck.Digital Photographs of your Mouth - You will be also asked to open your mouth and a digital photograph of the back of the mouth will be taken, as well as, pictures of the front and side of the head and neck.
16169227|NCT01630694|Procedure|Ultrasound Exam of the Tongue|The ultrasound study of the tongue will be performed after the series of laser scans. You will be examined in the sitting position. A small,handheld, curved ultrasound instrument will be placed under the chin to take images of the tongue. This exam should take less than a minute.
16169228|NCT01630681|Behavioral|Internet-based stepped care|Interactive support and Cognitive Behavioral Therapy
16169229|NCT01630668|Dietary Supplement|One-a-Day L. reuteri NCIMB 30242 supplement capsule|Once per day, 12 weeks
16169230|NCT01630668|Dietary Supplement|One-a-Day placebo capsule|Once per day, 12 weeks
16169231|NCT01630655|Drug|Torrent's Felodipine Extended-Release Tablets|
16169232|NCT01630642|Drug|Torrent's Clopidogrel Tablets USP 75 mg|
16169233|NCT01630616|Drug|Odanacatib|single oral dose, tablets, 10 or 50 mg
16169234|NCT01630616|Drug|Placebo|single oral dose, tablets
16169235|NCT01630590|Drug|Cabozantinib|Starting dose of 60 mg by mouth every day of a 21 day cycle.
16169236|NCT01630590|Drug|Androgen Ablation Therapy|Androgen ablation therapy, either by means of luteinizing hormone-releasing hormone super-agonist (of any formulation), LHRH antagonist, or surgical castration given upon decision of study doctor.
16169237|NCT01630577|Other|volume expansion using modified gelatin|Volume expansion using modified gelatin was determined according to a procedure formulated by modifying guidelines produced by Weil and Henning. The maximum volume infusion during the study test was fixed at 400 ml.
16169238|NCT01630564|Biological|Aldesleukin|Undergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin
16169239|NCT01630564|Procedure|Ex Vivo-Expanded Cord Blood Progenitor Cell Infusion|Undergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin
16169240|NCT01630564|Biological|Umbilical Cord Blood-Derived Lymphocyte Therapy|Undergo ex-vivo-expanded umbilical cord blood progenitor cell donor T-cell infusion with aldesleukin
16169241|NCT01630551|Dietary Supplement|Fishoil supplement|1 capsule per day
16169242|NCT01630551|Dietary Supplement|Olive Oil|1 capsule per day
16169243|NCT01630538|Drug|Cyclophosphamide|Cyclophosphamide 1.5 mg/kg orally daily for 180 days adjusted for renal function
16169244|NCT01630525|Other|Neuropsychological assessment|Neuropsychological assessment : MMSE (Greco), RL/RI-16 items (Van der Linden 2003), visual retention test (DMS48), verbal fluency (Thurstone et Thurstone 1964), TMT A and B (Reitan 1956), DSST (Weschler 1997), Clinical Dementia Rating Scale (Hughes 1982), image naming DO80 (Deloche et Hannequin 1997), Similarities and Digit Span subscores of the WAIS (Weschler 1997), Anxiety and Depression (GDS), activities of daily living (ADL-Katz and IADL-Lawton).
16169245|NCT01630525|Other|ophthalmologic checkup|Vision work-up, 30 minutes (VA, non invasive retinal imaging : non dilated optic fundus picture or OCT, ocular tension).
16169246|NCT01630525|Other|Automated non-invasive oculometry|Automated non-invasive oculometry : 45 minutes with rest periods : horizontal and vertical pro- and anti-saccades, prediction, spatial decision (Monsiman et al. Brain 2005,128:1267-127, items detection (Rösler et al. Cortex 2005 ;41 :512-519) and exploration/curiosity of non congruent images and faces according to Daffner et al. Neurology 1992 ;42 :320-328 and Loughland et al. Biol Psychiatry 2002 ;52 : 338-348).
16169247|NCT01630512|Behavioral|Mindfulness-Based Cognitive Therapy (MBCT)|The intervention consists of 8 weekly individual sessions of MBCT. Each session will be administered individually and will last 45 to 60 minutes.
16169248|NCT01630512|Behavioral|Cognitive Behavioral Therapy (CBT)|The intervention consists of 8 weekly individual sessions of CBT. Each session will be administered individually and will last 45 to 60 minutes.
16169249|NCT01630499|Behavioral|Tailored Lifestyle Intervention (TLI)|The intervention is a nutrition, physical activity, and behavioral weight management program that is tailored to the specific needs of breast cancer survivors.
16169250|NCT01630499|Behavioral|Commercial Weight Loss Program (CWLP)|This intervention is a generic, widely-available weight management program.
16169251|NCT01630473|Procedure|Corticotomy|After a periodontal full flap is dissected, by using small round burs, vertical lines (2 mm depth corticotomy) parallel to each root of the teeth in the anterior segment (canines and incisors) are created 5 mm beyond the apex in the maxillary bones and interconnecting the lines at the apex by horizontal corticotomies. Marginal bone crest is not touched by the surgical procedure.
16169252|NCT01630473|Procedure|Conventional orthodontics|Conventional orthodontic treatment
16169253|NCT01630434|Device|OCS Lung|OCS Lung will be used to preserve the donor lungs (Treatment Group).
16169254|NCT01630434|Device|Cold flush and storage|Donor lungs will preserved using standard cold flush and storage
16169255|NCT01630408|Drug|Paricalcitol|Paricalcitol oral capsules 1 mcg/day for 48 weeks
16169256|NCT01630395|Procedure|protective ventilation|low tidal volume and PEEP
16169257|NCT01630395|Procedure|Recruitment maneuver combined with protective ventilation|Low tidal volume, PEEP and recruitment maneuver
16169258|NCT01630369|Drug|insulin human (HR1799)|Pharmaceutical form: solution for injection Route of administration: subcutaneous
16169259|NCT01630356|Behavioral|in-person counseling|The interventionist provided in person counseling on eliminating child exposure to tobacco smoke to at least one daily smoker and a non-smoker mother in the household. The counseling session emphasized the following issues: a) importance of healthy environment at home, b) health dangers of smoking and exposure to secondhand smoke, c) why and how to quit smoking, and d) how to keep home air smoke-free.
16169260|NCT01630356|Device|Demonstration of PM2.5 Pollution|The study team measured the particulate matter (PM2.5) in the air using the TSI AM 510 Aerosol SidePak to compare the quality of indoor air with outdoor air and demonstrate the effect of smoking on indoor air quality in the intervention households. After completing the Side Pack PM2.5 measurement, the interventionist immediately downloaded the data to a laptop to visualize the results through graphical presentation of the PM2.5 fluctuations to family members.
16169261|NCT01630356|Behavioral|Follow-up Counseling Calls|Interventionists made two follow-up counseling calls to the primary contact in the intervention households, usually a non-smoking mother at one and two months after the in-person counseling session. These calls aimed at a) assessing the progress in meeting the goals set earlier, b) counseling on barriers to the change, and c) encouraging study participants to maintain the success or to set new goals. These calls also provided opportunity for the participants to ask questions or clarify issues
16169262|NCT01630356|Behavioral|Printed material|"The intervention group families received the tailored and culturally adjusted educational brochure developed by the study team.
~The control group received a brief educational leaflet on the hazards of SHS developed by the US Environmental Protection Agency."
16169263|NCT01630343|Drug|Paracetamol tablet and Tramadol capsule|Panadol 500mg tablet Q4H prn Tramadol 50mg capsule Q4H prn
16169264|NCT01630343|Drug|Panadol 500mg tablet, tramadol 50mg capsule|Regular Panadol 500mg tds with tramadol 50mg capsule tds for 3 weeks after injury
16169265|NCT01630330|Procedure|Ablation|Atrial Fibrillation Ablation with SmartTouch catheter
16169266|NCT01630330|Procedure|Ablation|Atrial Fibrillation Ablation with SmartTouch catheter
16169267|NCT01630317|Procedure|Peripheral line|Ultrafiltration therapy though peripheral line, two peripheral venous catheter will be placed in the arms.
16169268|NCT01630317|Procedure|Central line vein|Ultrafiltration therapy through central line, a central venous catheter will be placed in internal jugular or femoral vein.
16169269|NCT01630304|Behavioral|WelTel SMS service|"Weekly text message Mambo? (How are you?) to which participants are required to respond either Shida (problem) or Sawa (OK) within 48 hours. Shida responses and participants who do not respond are called by a clinician."
16169270|NCT01630291|Device|Electrode device|Lacrimal gland stimulation
16169271|NCT01630278|Drug|Ibuprofen|Very premature infants with a large ductus, selected by an early echocardiogram, will receive ibuprofen before 12 hours of life
16169272|NCT01630278|Drug|Placebo|Very premature infants with a large ductus, selected by an early echocardiogram, will receive placebo before 12 hours of life
16169273|NCT01630265|Other|Standard written discharge instructions|Group of caregivers who read the standard written discharge instructions prior to answering the questionnaire
16169274|NCT01630265|Other|Video Discharge Instructions|Group of caregivers who watched the 3 minute video covering the information in the standard written discharge instructions prior to answering the questionnaire
16169275|NCT01630252|Drug|PGL5001|PGL5001 320mg/day (160 mg twice a day) for 8 weeks + one unique DMPA 150 mg injection
16169276|NCT01630252|Drug|Placebo|PGL5001 matching placebo (twice a day) for 8 weeks + one unique DMPA 150 mg injection
16169277|NCT01630252|Drug|PGL5001|PGL5001 320mg/day (160 mg twice a day) for 20 weeks + DMPA 150mg injection. Second DMPA injection between 85 to 89 days after first injection
16169278|NCT01630252|Drug|Placebo|PGL5001 matching placebo (twice a day) for 20 weeks + DMPA 150mg injection. Second DMPA injection between 85 to 89 days after first injection
16169279|NCT01630252|Drug|PGL5001|PGL5001 320mg/day (160 mg twice a day) for 8 weeks + one unique DMPA 150 mg injection
16169280|NCT01630239|Procedure|Laser ablation|Laser ablation of hepatic tumors
16169281|NCT01630226|Drug|Neoadjuvant Cisplatin Chemotherapy|Patients will be treated with cisplatin chemotherapy at a dose of 75mg/m2 every three weeks for a total of four cycles (4 cycles of neoadjuvant chemotherapy).
16169282|NCT01630213|Dietary Supplement|Vitamin D3 + fish oil/fish oil placebo|Vitamin D3 2000 IU/day and fish oil (840 mg of omega 3-fatty acids; Omacor)/fish oil placebo per day
16169283|NCT01630213|Dietary Supplement|Vitamin D3 placebo + fish oil/fish oil placebo|Vitamin D3 placebo/day + fish oil (840 mg of omega 3-fatty acids; Omacor)/fish oil placebo/day
16169284|NCT01630200|Drug|Roflumilast|Roflumilast coated tablet, 500µg oral application, once daily in the morning
16169285|NCT01630200|Drug|Placebo|Placebo coated tablet (visually identical to 500µg Roflumilast tablet), oral application, once daily in the morning
16169286|NCT01630187|Drug|Carbetocin|Administration of carbetocin 50 mcg , after clamping the umbilical cord
16169287|NCT01630187|Drug|Carbetocin|Administration of carbetocin 100 mcg , after clamping the umbilical cord
16169288|NCT01630161|Behavioral|Usual Care|Standard care includes routine assessment of smoking behavior and brief clinical intervention. Smoking counseling for all participants in the current study will be completed by a Certified Tobacco Treatment Specialist consisting consists of brief counseling (<15 minutes) based on the 5 A's Clinical Practice Guidelines; Ask about tobacco use, Advise to quit, Assess willingness to make a quit attempt, Assist in quit attempt, Arrange for follow-up (Fiore et al., 2008). Patients receive information for local and state smoking resources (e.g., Quitline), pharmacotherapy options, and if interested, assistance with obtaining a prescription for pharmacotherapy. Follow-up with patients occurs at 2-weeks, only among those who are prescribed smoking medications (i.e., Varenicline, Bupropion).
16169289|NCT01630161|Behavioral|Smoking Relapse Prevention for Cancer Patients (SRP-CaP)|The proposed multimodal intervention consists of a series of easy-to-read relapse prevention booklets (Forever Free) that have shown to be efficacious with a general smoking population (Brandon et al., 2000; 2004), and digital video disk (DVD) customized to the needs of cancer patients (to be developed in Year One).
16169290|NCT01630148|Drug|Bemiparin|Bemiparin Sodium 3,500IU anti Xa/0.3 ml solution for injection in pre-filled syringe will be provided for each patient in Bemiparin group (Moderate, High and Highest risk groups for thromboembolism) 6 hours after surgery and then daily for up to 7 days.
16169291|NCT01630135|Drug|Fluticasone furoate|55 mcg/day, intranasal, 2 weeks
16169292|NCT01630135|Drug|Placebo|Placebo, intranasal, 2 weeks
16169293|NCT01630109|Drug|Metoclopramide|A one time dose of either Metoclopramide 5 mg or 10 mg (or placebo) given orally 30 minutes prior to pill capsule endoscopy.
16169294|NCT01630109|Drug|Placebo|A placebo capsule made to look like the metoclopramide capsule.
16169295|NCT01630096|Drug|Nu-Lytely|Bowl prep solution.
16169296|NCT01630083|Drug|epirubicin|Epirubicin will be administered at a dose of 50 mg/m^2 as a 15-minute intravenous infusion on day 1 of each cycle.
16169297|NCT01630083|Drug|oxaliplatin|Oxaliplatin will be administered at a dose of 130 mg/m^2 as a 2-hour intravenous infusion on day 1 of each cycle.
16169298|NCT01630083|Drug|capecitabine|The daily dose of capecitabine will be 1250 mg/m^2. Capecitabine tablets to be given once daily at a dose of 625 mg/m^2 orally in the evening of day 1 of each cycle and twice daily at a dose of 625 mg/m^2 orally on days 2 to 21 of each cycle; the morning dose of capecitabine on day 1 of each cycle to be omitted due to administration of zolbetuximab, epirubicin and oxaliplatin.
16169299|NCT01630083|Drug|zolbetuximab|Two different formats of zolbetuximab, comprising different strengths, to be provided. Vials contained 22 mg or 105 mg of zolbetuximab. Prior to administration, zolbetuximab will be reconstituted with 1.1 mL (22 mg zolbetuximab vials) or 5.0 mL (105 mg zolbetuximab vials) water for injection, which will result in a concentration of 20 mg/mL zolbetuximab. The extractable volume per vial will be 1 mL (for 22 mg zolbetuximab vials) or 5 mL (for 105 mg zolbetuximab vials). The reconstituted solution will be further diluted with sodium chloride 0.9% to a final concentration of 2 mg/mL zolbetuximab. Zolbetuximab will be administered as an intravenous infusion over 2 to 3 hours.
16169300|NCT01630070|Device|Self-expandable drug eluting stent|Self-Expanding Paclitaxel-Eluting stent
16169301|NCT01630057|Drug|Adjunctive Zonisamide|Patients will be gradually down-titrated from the first add-on following a drug-specific scheme decided by the investigator. Discontinued from the first add-on, patients will remain on duotherapy until the end of the study, or until the clinical situation mandates withdrawal from the study, e.g. in case of seizure worsening or adverse events.
16169302|NCT01630057|Drug|Replacement with Zonisamide|Patients will continue to receive zonisamide as third drug
16169303|NCT01630044|Device|TNM device|Non-invasive neurostimulator, home-use treatment for up to 43 days.
16169304|NCT01630018|Drug|Topotecan|1.5mg/m2 IV days 1,2,3,4,5 of each 21day cycle until 6cycle or disease progression
16169305|NCT01630018|Drug|Belotecan|0.5mg/m2 IV days 1,2,3,4,5 of each 21day cycle until 6cycle or disease progression
16169306|NCT01630005|Behavioral|talk therapy|Psychotherapy
16169307|NCT01629992|Other|Preoperative counseling|The intervention group received preoperative counseling by both orally and written. A written leaflet containing information was provided to each patient of this group.
16169308|NCT01629979|Procedure|Grafting with epidermal cells|"A superficial skin shaving excision will be obtained from pigmented skin using a dermatome. A cell suspension will be obtained by trypsinisation. Vitiligo skin will be dermabraded by Erbium: Yag laser after local anaesthesia. The cell suspension will be spread on the dermabraded skin area and fixed with dressings. Keratinocyte, and melanocyte counts will be performed on an aliquot of the cell suspension. One symmetrical patch of vitiligo will be chosen as control and left untreated.
~Narrow-band UVB treatment: Four weeks after transplantation of epidermal cells, the grafted and control patch will be treated by Narrow-band UVB. Treatment will be performed 2 times a week. Narrow-band UVB treatment will be performed for at least 3 months or 24 treatments."
16169309|NCT01629979|Radiation|UVB treatment|the control patch will be treated by Narrow-band UVB. Treatment will be performed 2 times a week. Narrow-band UVB treatment will be performed for at least 3 months or 24 treatments.
16169310|NCT01629966|Drug|Placebo|Matching 10 mg and 20 mg placebo tablets, once per day, oral administration,
16169311|NCT01629966|Drug|Vilazodone|Vilazodone, 20mg, oral administration once per day.
16169312|NCT01629966|Drug|Vilazodone|Vilazodone, 40mg, oral administration once per day.
16169313|NCT01629953|Other|Group vocational intervention|Group based manualized vocational rehabilitation
16169314|NCT01629953|Other|Supported Employment Condition|Veterans in this condition will receive a proven group based manualized vocational rehabilitation intervention
16169315|NCT01629914|Behavioral|Mindfulness Meditation|8-week, group-based mindfulness meditation intervention
16169316|NCT01629901|Device|ThermoNeuroModulation (TNM) Device|Non-invasive neurostimulator used for up to 20 minutes in a session.
16169317|NCT01629888|Other|1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).|1 = Intervention 1 (3 test products/day)
16169318|NCT01629888|Other|2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters|2 = Intervention 2 (3 control products/day)
16169319|NCT01629875|Drug|Generic equivalent of Clostridium Botulinum A Toxin|
16169320|NCT01629875|Drug|Botox (Clostridium Botulinum A Toxin)|
16169321|NCT01629862|Device|Continuous positive airway pressure|CPAP at therapeutic pressure; ResMed S9 device in fixed pressure mode (Sydney, Australia).
16169322|NCT01629862|Device|Sham continuous positive airway pressure|CPAP at non-therapeutic pressure; ResMed S9 device using a ResMed sham mask (Sydney, Australia).
16169323|NCT01629849|Drug|Placebo to BI 1021958 qd|tablet
16169324|NCT01629849|Drug|BI 1021958 bid|tablets
16169325|NCT01629849|Drug|Placebo to BI 1021958 bid|tablets
16169326|NCT01629849|Drug|BI 1021958 qd|tablet
16169327|NCT01629823|Device|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage)|Continuous Positive Airway Pressure device (Resmed, Swift, Mirage): Participants will be randomized to one of three pre-set CPAP pressures: less than 1 cm water (H₂O), 5 cm H₂O or 10 cm H₂O. They will be instructed to use the CPAP device every night for 12 weeks. Methacholine airways reactivity will be measured at the end of these 12 weeks and again after a 2-week washout period, 14 weeks after randomization.
16169328|NCT01629810|Device|Whole body periodic acceleration (Exer-Rest)|Lying on the vibrating bed for 45 minutes per session for 10 sessions over 2 weeks.
16169329|NCT01629797|Behavioral|Educational script on Acne|An educational script on Acne will be presented by investigator
16169330|NCT01629784|Behavioral|Cutaneous Lupus educational script|Subjects will listen to a short informational script on Cutaneous lupus and skin protection
16169331|NCT01629758|Biological|Denenicokin|
16169332|NCT01629758|Biological|Nivolumab|
16169333|NCT01629745|Genetic|gene expression analysis|
16169334|NCT01629745|Other|flow cytometry|
16169335|NCT01629745|Other|laboratory biomarker analysis|
16169336|NCT01629732|Drug|Daclatasvir|Film coated tablet, Oral, 60 mg, Once daily, 12 or 24 weeks
16169337|NCT01629732|Drug|Daclatasvir|Film coated tablet, Oral, 60 mg, Once daily, 24 weeks
16169338|NCT01629732|Drug|BMS-986094|Capsule, Oral, 100 mg, Once daily, 12 or 24 weeks
16169339|NCT01629732|Drug|BMS-986094|Capsule, Oral, 200 mg, Once daily, 12 or 24 weeks
16169340|NCT01629732|Drug|BMS-986094|Capsule, Oral, 200 mg, Once daily, 24 Weeks
16169341|NCT01629732|Drug|Ribavirin|Film coated tablet, Oral, 1000 mg or 1200 mg based on weight, Twice daily, 12 or 24 weeks
16169342|NCT01629732|Drug|Placebo for BMS-986094|Capsule, Oral, 0 mg, Once daily, 12 or 24 weeks
16169343|NCT01629706|Device|Balafilcon A contact lens|Commercially marketed silicone hydrogel contact lens
16169344|NCT01629706|Device|Habitual contact lenses|Commercially marketed silicone hydrogel contact lenses as prescribed by eye care practitioner, brand and power
16169345|NCT01629706|Device|Renu multi-purpose solution|Commercially marketed solution for use in removing protein, cleaning, conditioning, and disinfecting contact lenses.
16169346|NCT01629706|Device|ClearCare|Commercially marketed hydrogen peroxide system for cleaning and disinfecting contact lenses
16169347|NCT01629706|Device|Habitual lens care|Lens care per habitual use
16169348|NCT01629693|Device|Lotrafilcon B contact lenses|Silicone hydrogel contact lenses (sphere or toric) per subject's habitual prescription
16169349|NCT01629693|Device|Comfilcon A contact lenses|Silicone hydrogel contact lenses (sphere or toric) per subject's habitual prescription
16169350|NCT01629680|Drug|Moxaverine|Moxaverine-hydrochloride, coated tablets containing 150 mg moxaverine (Kollateral forte, Ursapharm. Saarbrücken, Germany), dosage: 900 mg, administrated per os in three equal doses of 300 mg at two hour intervals
16169351|NCT01629680|Drug|Placebo|coated tablets identical in number and appearance as the study drug
16169352|NCT01629667|Biological|Tralokinumab|Participants will receive Tralokinumab 400 mg IV infusion Q4W for 68 Weeks.
16169353|NCT01629667|Biological|Tralokinumab|Participants will receive Tralokinumab 800 mg IV infusion Q4W for 68 Weeks.
16169354|NCT01629667|Other|Placebo|Participants will receive placebo IV once every 4 Weeks (Q4W) for 68 Weeks.
16169355|NCT01629654|Behavioral|Health promotion program|"A 13 weeks organized program:
~One group session about poststroke fatigue involving both patient and relatives
~Two personal meetings, involving both patient and relatives
~Three telephone meetings, involving only patient"
16169356|NCT01629628|Drug|Adalimumab|Subcutaneous adalimumab injections, loading dose of 160 mg and 80 mg on 0 and 2 weeks and maintenance of 40 mg every other week for the duration of the study.
16169357|NCT01629628|Drug|6 Mercaptopurine|"6MP will be administered orally starting at a dose of 6MP of 50mg/day with escalating doses every 1-2 weeks as tolerated, to a target dose of 1-1.5 mg/kg.
~--------------------------------------------------------------------------------"
16169358|NCT01629615|Drug|BKM120|BKM120 oral capsules. 100 mg daily in cycles of 28 days, until disease progression
16169359|NCT01629602|Procedure|the Boomerang Nerve Flap|The nerve branch was combined with the boomerang flap for simultaneous repair of soft tissue loss and PDN defect in these awkward areas.
16169360|NCT01629589|Biological|Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel®)|0.5 mL, Intramuscular
16169361|NCT01629589|Biological|Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed (BOOSTRIX®)|0.5 mL, Intramuscular
16169362|NCT01629576|Other|economic incentive|economic incentive for weight loss
16169363|NCT01629576|Other|economic incentive|economic incentive for weight loss
16169364|NCT01629563|Drug|PGL4001 5 mg|PGL4001 5 mg daily administration
16169365|NCT01629563|Drug|PGL4001 10 mg|PGL4001 10mg daily administration
16169366|NCT01629550|Procedure|skin disinfection prior catheter insertion|
16169367|NCT01629537|Procedure|Stellate Ganglion Block injection with ropivicane|For participants receiving the stellate ganglion injection with ropivicaine, a 22 g needle will be directed percutaneously to the anterolateral C6 vertebral body Using ultrasound guidance to avoid the nearby vascular structures and identify the appropriate vertebral level and tissue plane. After negative aspiration for blood and CSF, and digital subtraction, 2cc of Iohexol,(Omnipaque 180) will be injected through the needle under live fluoroscopy to visualize dye spread over the pre-vertebral plane At this point, 7 cc 0.5% ropivicaine will be injected and the needle will be removed.
16169368|NCT01629537|Procedure|Placebo Procedure|In participants randomized to the placebo injection, the same positioning, monitoring, sterile preparation and technique and local anesthesia protocol will be used. The 22 g needle will instead be placed in the subcutaneous, superficial tissues overlying the C6 tubercle, but superficial enough that the prevertebral fascial plane of the stellate ganglion will not be breached. Using fluoroscopic guidance, this needle will be injected with 2 cc of contrast dye to confirm superficial spread. The needle will then be injected with 5 cc of preservative free normal saline and the needle will be removed.
16169369|NCT01629511|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo stem cell transplant
16169370|NCT01629511|Biological|Anti-Thymocyte Globulin|Given IV
16169371|NCT01629511|Drug|Busulfan|Given IV
16169372|NCT01629511|Drug|Clofarabine|Given IV
16169373|NCT01629511|Biological|Filgrastim|Given SC
16169374|NCT01629511|Drug|Gemcitabine|Given IV
16169375|NCT01629511|Drug|Methotrexate|Given IV
16169376|NCT01629511|Drug|Tacrolimus|Given PO
16169377|NCT01629498|Radiation|Image Guided Radiation Therapy|Undergo image-guided IMRT
16169378|NCT01629498|Radiation|Image Guided Radiation Therapy|Undergo image-guided IMPT
16169379|NCT01629498|Radiation|Intensity-Modulated Radiation Therapy|Undergo image-guided IMRT
16169380|NCT01629498|Radiation|Intensity-Modulated Radiation Therapy|Undergo image-guided IMPT
16169381|NCT01629498|Other|Laboratory Biomarker Analysis|Optional correlative studies
16169382|NCT01629498|Radiation|Photon Beam Radiation Therapy|Undergo image-guided IMRT
16169383|NCT01629498|Radiation|Proton Beam Radiation Therapy|Undergo image-guided IMPT
16169384|NCT01629498|Other|Questionnaire Administration|Ancillary studies
16169385|NCT01629485|Behavioral|Online Video Curriculum|A video curriculum has been designed for the purpose of educating general surgery residents in laparoscopic hernia repairs. The curriculum covers topics from basic anatomy, selection of patients, management, and operative technique.
16169386|NCT01629485|Behavioral|Whole Task Mastery Training|Trainees will undergo whole task mastery training in the TEP simulator. The benchmarks for mastery training in the setting of whole task tep repairs was established with performance measures of multiple staff surgeons previously.
16169387|NCT01629485|Behavioral|Part Task Mastery Training|Trainees will undergo part task mastery training in the TEP simulator. The benchmarks for mastery training in the setting of part task tep repairs was established with performance measures of multiple staff surgeons previously.
16169388|NCT01629472|Behavioral|VSLA + Gender dialogue groups|Dialogue groups discussing household discussion making and gender norms facilitated by IRC.
16169389|NCT01629459|Behavioral|Resistance exercise and protein supplementation|Resistance exercise training will occur 3x/wk for 12 wks at a physical therapy or cardiac rehabilitation facility near the participant's home. Participant will take 42 grams of supplementation protein daily.
16169390|NCT01629446|Drug|Lofexidine hydrochloride|Single Dose = Solution containing 400 μg lofexidine HCl and a tracer amount of 14C lofexidine
16169391|NCT01629420|Drug|KLH-2109|
16169392|NCT01629420|Drug|KLH-2109|
16169393|NCT01629407|Other|Standard of Care|Patients with glaucoma treated with standard of care at the discretion of the physician. There is no specific treatment required for this study.
16169394|NCT01629394|Drug|Sugammadex|Single dose of 2 mg/kg corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)]
16169395|NCT01629394|Drug|Sugammadex|Single dose of sugammadex 2 mg/kg ( ideal body weight )
16169396|NCT01629394|Drug|Neostigmine|Single dose of neostigmine 50 μg/kg corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)]
16169397|NCT01629394|Drug|Neostigmine|Single dose of neostigmine 50 μg/kg ( ideal body weight )
16169398|NCT01629394|Drug|Sugammadex|Single dose of 2 mg/kg corrected body weight [corrected body weight = ideal body weight + 40%( real body weight - ideal body weight)]
16169399|NCT01629394|Drug|Sugammadex|Single dose of sugammadex 2 mg/kg ( ideal body weight )
16169400|NCT01629394|Drug|Neostigmine|Single dose of neostigmine 50 μg/kg corrected body weight [corrected body weight = ideal body weight + 40%(real body weight - ideal body weight)]
16169401|NCT01629394|Drug|Neostigmine|Single dose of neostigmine 50μg/kg ( ideal body weight )
16169402|NCT01629381|Drug|Rivaroxaban|10 mg os once daily for 1 week
16169403|NCT01629381|Drug|placebo|10 mg os once daily for 1 week
16169404|NCT01629368|Drug|Carbamazepine|Multiple doses of carbamazepine
16169405|NCT01629368|Drug|RO4917523|Single dose of RO4917523
16169406|NCT01629342|Behavioral|Standardized activities|"All patients do each of the following standardized activities over a course of 2 days:
~treadmill walking (5 minutes, 1 and 2km/h)
~staircase walking (1 floor, normal pace)
~cycling with fixed load (5 minutes)
~standing up from sitting position and sitting down again (x5)
~standing up from supine position
~turning from left to right and back while lying in bed
~raising outstretched arm 90° (x5, standing position)
~eating (5 minutes, sitting position)
~drinking a glass of water
~sleeping (6 hours)"
16169407|NCT01629329|Drug|Aspirin, Acetaminophen, Caffeine pills|One time dose of 2 pills each containing acetaminophen 250mg, aspirin 250mg and caffeine 65mg in each tablet. Simultaneous administration of placebo(5ml of saline administered IV)
16169408|NCT01629329|Drug|Prochlorperazine 10mg|One time dose of Prochlorperazine 10mg/2ml given IV slow push. Simultaneous administration of 2 unmarked placebo pills.
16169409|NCT01629316|Behavioral|Text reminders, counseling, and link coordination|This is an intervention with text reminders, counseling that involves motivational interviewing, and link coordination
16169410|NCT01629316|Behavioral|Standard of care - control arm|The control arm is standard of care for each subject.
16169411|NCT01629303|Procedure|sacral nerve modulation|"After the definitive implantation, stimulators are placed in position ON (arm on-off) or OFF (arm off-on) for the first arm and in position OFF for the second arm during 8 weeks.
~Then all the stimulators are switched OFF (both first and second arms) for 15 days.
~Finally stimulators are maintained in position OFF for the first arm and switched ON for the second arm during 8 weeks"
16169412|NCT01629290|Device|Enamel Pro|Varnish treatment containing 5% NaF
16169413|NCT01629290|Device|Duraphat|Varnish treatment containing 5% NaF
16169414|NCT01629290|Device|Vanish|Varnish treatment containing 5% NaF
16169415|NCT01629290|Device|Placebo|Bland varnish containing no NaF
16169416|NCT01629277|Device|Closed-loop|Subcutaneous insulin delivery will be adjusted according to the computer-based algorithm advice, based on subcutaneous glucose readings
16169417|NCT01629277|Device|standard insulin pump|Subcutaneous insulin delivery will be administered according the standard insulin pump settings
16169418|NCT01629264|Device|Ocular Response Analyzer|To measure corneal biomechanics, specifically corneal hysteresis (CH) and the Corneal Resistance Factor (CRF). The devise measures in a non-contact manner, by analyzing the deformation of the cornea upon a defined pulse of air.
16169419|NCT01629264|Device|Scheimpflug measurement|A Scheimpflug camera will be used in a non-contact manner to assess topographical data from the anterior and posterior corneal surface as well as detailed data on corneal thickness.
16169420|NCT01629264|Other|Blood sample|A blood sample will be taken at 6 months after surgery to determine the levels of several hormones. The blood needed to détermine hormone levels during pregnancy will be acquired during the routine examinations that are performed during pregnancy. Here, blood is taken routinely and an additional volume is taken for the purpose of this study.
16169421|NCT01629251|Device|Closed-loop insulin delivery|Subcutaneous basal insulin delivery will be adjusted following the advice by a computer-based algorithm, based on subcutaneous sensor glucose readings. Standard or reduced meal insulin dosing will be performed in a randomised design.
16169422|NCT01629225|Drug|Candesartan|To investigate the response to candesartan among southwestern Han Chinese with essential hypertrension
16169423|NCT01629212|Drug|Tiropramide HCl 100mg|
16169424|NCT01629212|Drug|Octylonium bromide 20mg|
16169425|NCT01629199|Drug|rhEGF(recombinant human Epidermal Growth Factor)|
16169426|NCT01629199|Drug|placebo of rhEGF(recombinant human Epidermal Growth Factor)|
16169427|NCT01629186|Other|NPO with Nose-close and Abdomen-compression|Infants with body weight (BW) <5.0 kg and receiving nasal diagnostic or interventional FB were enrolled. Under NPO (0.5 L/kg/min), when infant's heart rate (HR) <80 beats/min or oxygen saturation (SpO2) <85% for more than 10 seconds, rescue NC-AC was initiated. It was performed by (1) increased NPO flow to 0.5-1.0 L/kg/min; (2) NC 1 second for inspiration; and (3) AC 1 second for expiration with simultaneously released nostrils. Repeat doing steps (2) and (3) at a rate of 30 cycles/min until HR, SpO2, and blood pressure (BP) returned to normal.
16169428|NCT01629173|Procedure|Dynamic impression insole|We sequentially padded (1)a 6.5-mm thick P-cell (21 Shore A hardness, Acor orthopedic Inc. Cleveland, Ohio, USA), and (2)a piece of metatarsal pad and arch support made of Ethylene Vinyl Acetate (EVA) (40 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany) to the bottom of the impressed 9-mm thick plastazote (15 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany) with double-sided adhesive tape in the forefoot region and just proximal to the first, second, and third metatarsal head region. We additionally padded a 2-mm thick Multiform (30 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany) on the top of the impressed insole with double-sided adhesive tape.
16169429|NCT01629173|Procedure|Custom molded insole|The custom molded insole was made by sequentially padded Multiform (30 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany), P-cell (21 Shore A hardness, Acor orthopedic Inc. Cleveland, Ohio, USA), Ethylene Vinyl Acetate (EVA)(40 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany), and cork (50 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany) on the positive plaster cast impressed by an impression box while holding the subtalar joint at a neutral position.
16169430|NCT01629173|Procedure|9-mm uncompressed Plastazote|We used 9-mm flat Plastazote(15 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany) as an insole
16169431|NCT01629173|Procedure|7-mm Ethylene Vinyl Acetate (EVA)|We used 7-mm flat Ethylene Vinyl Acetate (EVA) (40 Shore A hardness, Schein orthopadie service KG. Remscheid, Germany) as an insole
16169432|NCT01629147|Dietary Supplement|Biogaia|5 drops containing Lactobacillus reuteri Protectis
16169433|NCT01629147|Other|Placebo|5 drops
16169434|NCT01629134|Device|Crosslinked hyaluronic acid gel|All treatments are carried out according to the physician's experience and the Directions for Use
16169435|NCT01629121|Behavioral|education intervention|"The brain injury prevention education intervention included case scenarios as well as education about the benefits of bicycle helmet use. The intervention was designed to be sensitive to the age and educational level of the study participant and his or her parents. Educational materials were chosen to provide use of the five senses to enhance the learning experience. The intervention took place in the privacy of the patient's hospital room. The study was designed so as not to interfere with the hospital standard of care.
~The proper way to fit the bicycle helmet was demonstrated."
16169436|NCT01629082|Drug|Clofarabine|
16169437|NCT01629082|Drug|Lenalidomide|
16169438|NCT01629069|Behavioral|Mindfulness based Resilience Training|6 weekly group sessions
16169439|NCT01629056|Procedure|ablation|RF ablation to the left atrium of the heart, guided by ECI-contact information (active arm)
16169440|NCT01629056|Procedure|RF ablation|RF ablation to the left atrium of the heart, without the use of ECI-contact information (control arm)
16169441|NCT01629004|Other|FOBT kit|Mailed FOBT kit with educational materials and mailed CRC screening invitation on behalf of family physician.
16169442|NCT01629004|Other|Mailed invitation|Mailed CRC screening invitation alone on behalf of family physician.
16169443|NCT01628991|Behavioral|behavioural program|interventional behavioural program
16169444|NCT01628991|Device|Iranian version of vaginal cones|intravaginal device(vaginal cone) for promote the pelvic floor exercises
16169445|NCT01628978|Other|determination by auscultation|determination of depth of endotracheal tube placement by auscultation
16169446|NCT01628978|Other|determination by ultrasound|determination of depth of endotracheal tube placement by ultrasound
16169447|NCT01628965|Drug|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
16169448|NCT01628952|Drug|Transversus Abdominis Plane|PIA coelioscopic
16169449|NCT01628952|Drug|Curare|IAP coelioscopic
16169450|NCT01628939|Other|MRI of the lumbar spine|standard protocol, approximately 30 minutes
16169451|NCT01628939|Other|manual segmental examination of the lumbar facet joints|use of three different segmental facet joint provocation tests (spinal palpation, segmental rotation and springing-test) from Th12-L1 to L5-S1
16169452|NCT01628926|Drug|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
16169453|NCT01628926|Drug|Ropinirole|Ropinirole oral administration TID up to 15.0 mg/day
16169454|NCT01628926|Drug|Placebo|SPM962-placebo patch and Ropinirole-placebo tab
16169455|NCT01628913|Drug|BEZ235|BEZ235 400 mg bid p.o. (by mouth, twice daily)
16169456|NCT01628913|Drug|Everolimus|Everolimus 10 mg qd p.o. (by mouth, daily)
16169457|NCT01628900|Other|care management arm N°1 vs arm N°2|7 days for mono-antibiotherapy at hospital
16169458|NCT01628900|Other|Care management|Hospital vs home
16169459|NCT01628887|Other|Educational Intervention|Undergo Bilingual Breast Cancer Educational Intervention
16169460|NCT01628874|Device|J-Tip|Used once for both arms prior to lumbar puncture. The Experimental arm will receive 0.5 mL (5mg) of 1% Lidocaine. The Active Comparator arm will receive normal saline. This will occur after the cream has been placed for 30 minutes and wiped away and prior to the lumbar puncture.
16169461|NCT01628874|Drug|EMLA|In the Active Comparator arm, lidocaine 2.5% and prilocaine 2.5% cream placed over area where lumbar puncture will occur for at least 30 minutes. This same procedure will occur for the Experimental arm with a placebo cream instead. This will occur once prior to the J-Tip injection and lumbar puncture.
16169462|NCT01628874|Drug|Lidocaine|5 mg given via J-Tip once, repeat dosing as needed in the Experimental group. A placebo will be given in the Active Comparator group.
16169570|NCT01628029|Procedure|Sham Intervention|Undergo sham light therapy
16169463|NCT01628861|Device|MyRestBreak 1.0|"Prompting software (MyRestBreak 1.0 copyright Vikram Sharma) will be installed on the work computer. A prompt with the message stand up, take a break is placed on the screen of the work computer for 1 minutes every 30 minutes, from the time the computer is switched on in the morning. The prompt is contained in a window 11x9 cm in the centre of the screen. The prompt cannot be removed or minimised, but work can continue in any windows visible around the prompt. The prompt is on the computer for 5 days."
16169464|NCT01628861|Behavioral|education talk and leaflet|A short educational talk, read from a script, regarding the health risks of prolonged sitting, stating that standing every 30 minutes could be beneficial. A short information leaflet stating with the same message is also provided.
16169465|NCT01628848|Drug|SPM 962|SPM 962 transdermal patch once a daily up to 36.0 mg/day
16169466|NCT01628848|Drug|Placebo|Placebo transdermal patch
16169467|NCT01628835|Behavioral|Low dietary glycemic index diet|Based on the national diet and physical activity recommendations for pregnant women (total energy intake, protein and vitamin etc.), counseling for a low dietary glycemic index diet will be provided
16169468|NCT01628835|Behavioral|National recommendation diet|Provision of food and dietary counseling according to the national prenatal nutrition recommendation without GI information
16169469|NCT01628822|Behavioral|Active relaxation|The length of follow-up will be 12 weeks.Patients will be seen once every seven days by a relaxation therapist for 5 weeks (6 sessions) and will be followed by the center physician investigator regarding drug therapy
16169470|NCT01628822|Behavioral|Placebo|Patients are been asked to relax alone in a quiet room. They are coming every 7 days for 5 weeks (6 sessions) and will be followed by the investigator regarding drug therapy
16169471|NCT01628809|Behavioral|Mindfulness-Based Stress Reduction|three-day mindfulness-based meditation retreat program
16169472|NCT01628796|Other|contrast material injection|using ultrasound to locate ac joint and injecting contrast material to ensure that the dye is actually in the joint
16169473|NCT01628783|Drug|escitalopram 10 mg|orally once daily
16169474|NCT01628783|Drug|Placebo|once daily
16169475|NCT01628770|Drug|Iron isomaltoside 1000|Iron molecule iron isomaltoside 1000 (Monofer) have been introduced in the market, which can be given in intravenous infusion forms, in a relatively short period of time, in a single setting, after calculation of the required dose. It can be given in a dose of 20mg/kg body weight.
16169476|NCT01628770|Drug|Ferrous sulphate|200mg twice daily
16169477|NCT01628731|Drug|furosemide|furosemide, intravenous, continuous infusion, 0.2 mg/kg/h for 24 hours
16169478|NCT01628731|Drug|ethacrynic acid|ethacrynic acid, intravenous, continuous infusion, 0.2 mg/kg/h for 24 hours
16169479|NCT01628718|Behavioral|Adaptive Disclosure (AD)|Adaptive Disclosure (AD) is an eight-session fully manualized and piloted intervention designed specifically for Marines with PTSD stemming from a variety of traumatic deployment experiences. The approach combines imaginal exposure to activate trauma-related emotions and beliefs and cognitive and experiential techniques to modify maladaptive interpretations of the implication of various combat and operational experiences that contribute to symptoms and dysfunction.
16169480|NCT01628718|Behavioral|Cognitive Processing Therapy, cognitive version only (CPT-C)|"Cognitive Processing Therapy (CPT) is a 12-session manualized therapy for posttraumatic stress disorder. The theory behind CPT conceptualizes PTSD as a disorder of non-recovery in which erroneous beliefs about the causes and consequences of traumatic events produce strong negative emotions and prevent accurate processing of the trauma memory and natural emotions emanating from the event. A significant contributor to the interruption of natural recovery process is the ongoing use of avoidance as a coping strategy. CPT incorporates trauma-specific cognitive techniques to help individuals with PTSD more accurately appraise these stuck points and progress toward recovery."
16169481|NCT01628705|Other|Nutritional intervention|"The subjects were undergoing nutritional intervention was reduced by 500 kcal per day of habitual caloric intake.
~The proportion of daily intake of macronutrient in the moderate-fat diet was: 30% fat (saturated fat <7%, monounsaturated 10-15% and polyunsaturated 10%, respectively to total calories), 15% of protein, and 55% of carbohydrates. The dietary cholesterol was less than 200 mg/day, fiber intake was increased to 25 grams per day (50% soluble fiber)."
16169482|NCT01628705|Dietary Supplement|Green tea|The patients drank secha green tea. Subjects of the INT group were instructed on how to prepare the green tea infusion. Each cup was prepared using 3g of dried green tea in 300ml of hot water (temperature 80°C)for 4 min. It was drunk fresh and without sugar. The treatment consisted of 2 cup/day of green tea, one in the morning and one at night. The amount of epigallocathechin-3-gallate was 498mg/day.
16169483|NCT01628692|Drug|Daclatasvir|Tablets, oral, 30 mg, once daily
16169484|NCT01628692|Drug|Simeprevir|Capsule, oral, 150 mg, once daily
16169485|NCT01628692|Drug|Ribavirin|Tablets, oral, 500-600 mg, twice daily
16169486|NCT01628679|Behavioral|Physical therapy treatment|Subjects will be given pelvic floor motor control,proprioception and relaxation exercises. This will be with and without the use of external surface Electromyography (EMG) biofeedback. Education will also be given on pain management, female sexual response and vestibulodynia. Subjects will also practice inserting vaginal inserts of graduating diameter into their vaginas, practicing the skills learned in physical therapy sessions.
16169487|NCT01628666|Drug|Incremental|Single dose of Cefazolin and Vancomycin preoperatively, bacitracin wash and cefalexin post operative.
16169488|NCT01628666|Drug|Conventional|Cefazolin preoperative
16169489|NCT01628653|Device|U-SMART|4-weeks' training
16169490|NCT01628640|Other|Laboratory Biomarker Analysis|Correlative studies
16169491|NCT01628640|Other|Pharmacological Study|Correlative studies
16169492|NCT01628640|Biological|Recombinant Vesicular Stomatitis Virus-expressing Interferon-beta|Given intratumorally
16169493|NCT01628627|Device|Frequency Modulated Neural Stimulation (FREMS) (Aptiva)|FREMS consisted of sequences of biphasic (negative and positive), asymmetric and electrically balanced pulses, composed of: 1) an active phase of high negative voltage spike (variable, max -300 V) and extra short duration (variable, 10-100 μsec, mostly ~40 μsec); followed by: 2) a recharging phase of low voltage and long duration (0.9 - 999 msec); pulse frequency was variable, ranging 1 to 1,000 Hz, mainly in the low range 1-50 Hz. Three cycles of 10 consecutive (one a day for 5 days/week) applications to both lower limbs were delivered.
16169571|NCT01628029|Drug|Therapeutic Melatonin|Given PO
16169762|NCT01626534|Drug|trigagrelor|180 mg loading dose then 90 mg Twice a day
16169494|NCT01628627|Device|sham treatment (Aptiva)|The sham treatment consisted of no electrical pulses delivered by the same device used to deliver the FREMS treatment and with the same treatment procedure and schedule.
16169495|NCT01628614|Other|Standard of Care|Patients with POAG or OHT. All care (including treatment and diagnostic procedures) provided is at the discretion of the participating physicians according to their clinical judgment and the local standard of medical care.
16169496|NCT01628601|Drug|Fixed combination 0.3 mg bimatoprost and 5 mg timolol|Patients with POAG or OHT prescribed GANfort® (fixed combination 0.3 mg bimatoprost and 5 mg timolol) treatment in a dose determined by the physician prior to study entry
16169497|NCT01628588|Drug|bimatoprost 0.01%|Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry
16169498|NCT01628575|Procedure|PAO|all patients underwent periodontal surgery for bone decortication followed by orthodontic treatment
16169499|NCT01628562|Drug|Esmolol|Esmolol 50 mcg/kg/min
16169500|NCT01628562|Drug|Remifentanil|Remifentanil 0.5 mcg/kg/min
16169501|NCT01628549|Drug|50 mg P005672-HCl|P005672-HCl administered as an oral capsule(s) once daily
16169502|NCT01628549|Drug|Placebo|Dose-matched Placebo capsule administered as an oral capsule(s) once daily
16169503|NCT01628549|Drug|100 mg P005672-HCl|P005672-HCl administered as an oral capsule(s) once daily
16169504|NCT01628536|Dietary Supplement|Black cohosh|Remifemin 20 mg tablet orally twice per day x 4 weeks
16169505|NCT01628523|Other|For inclusion in the study, patients will have to require mechanical ventilation either via an endotracheal tube or tracheostomy tube.|Mechanical ventilation via an endotracheal tube or tracheostomy tube
16169506|NCT01628510|Device|Dandle Roo/Dandle Wrap|Infant remains in the Dandle Roo/Dandle Wrap throughout the NICU stay when the infant is lying in the isolette or crib, but is taken out for hands on care times or when held.
16169507|NCT01628510|Other|Traditional NICU Positioning|These methods aim at providing containment and flexion and may consist of interventions such as swaddling, use of boundaries around the infant, rolled blankets, Snuggly®, or Bendy Bumper®
16169508|NCT01628484|Other|prick lancet|For the pricking skin preparation, sterile prick lancets for 1mm point skin testing will be used. They are used for allergy diagnostics in daily routine.
16169509|NCT01628484|Other|Tape stripping|For the tape stripping in the skin preparation test conventional self adhesive tape by Tesafilm® is used.
16169510|NCT01628484|Other|Microneedle|To induce a large number of microchannels with a maximal depth of 150µm into the cornea layer a small patch of 351 tiny needles is used, which is on the market in the US and is intended for preparing the skin for transdermal application of topical dermatology products.
16169511|NCT01628471|Drug|decitabine in combination with genistein|decitabine IV infusion ( 10 hrs total), doses from 60 to 500 mg/m2 + fixed daily oral dose of 300 mg genisteine
16169512|NCT01628458|Procedure|radiofrequency ablation (RFA)|RFA with CELON bipolar probes. Settings: Power 30 watts, total energy 15 KJ.
16169513|NCT01628445|Drug|liraglutide|liraglutide titrated to 1.8 mg sc daily
16169514|NCT01628445|Drug|placebo injection|placebo injected sc daily volume equal to active comparator
16169515|NCT01628432|Procedure|conservative hysterectomy I|conservative hysterectomy for benign disease
16169516|NCT01628432|Procedure|Conservative hysterectomy II|bilateral salpingectomy during hysterectomy without conservation of the ovaries
16169517|NCT01628419|Behavioral|Health intervention|"physical activity program at the workplace - once a week with a certified trainer. (The program will include: aerobic exercises as well as resistance exercises). The employees will encourage to perform two additional workouts during the week.
~Nutritional counseling for the kitchen staff Lectures - lectures will be given at each worksite on different topics: physical activity, nutrition, sleeping behaviour, mental aspects."
16169518|NCT01628406|Procedure|Treatment at the neurosurgery departement|Treatment at the neurosurgery departement
16169519|NCT01628393|Drug|Ozanimod|Oral capsule taken once a day
16169520|NCT01628393|Drug|Placebo|Oral capsule taken once a day
16169521|NCT01628380|Procedure|Cytoreductive Surgery and HIPEC|"CRS: radical surgery, associated to any surgical procedure needed to obtain a zero or ≤ 0.25cm residual tumor (peritonectomy, bowel resection, diaphragmatic stripping, gastric resection, etc.).
~HIPEC: Cisplatin (CDDP) (100 mg/m2 of body surface area) + Paclitaxel (175mg/m2 of body surface area). Closed/open technique, as preferred. Duration: 90 minutes. Mean Intra-abdominal Temperature: 42°C."
16169522|NCT01628380|Procedure|CRS alone|CRS: radical surgery, associated to any surgical procedure needed to obtain a zero or ≤ 0.25cm residual tumor (peritonectomy, bowel resection, diaphragmatic stripping, gastric resection, etc.)
16169523|NCT01628367|Procedure|Minimally Traumatic Tooth Extraction|"The surgeon will perform a minimally traumatic tooth extraction in the following fashion. Intrasulcular incisions will be performed with at 15-C scalpel around the tooth to be extracted.
~A periotome will then be introduced into the periodontal ligament space in order to sever the subcrestal attachment and expand the periodontal ligament space. Elevators will be used to initiate luxation of teeth. After significant mobility has been achieved through elevation, forceps will be used only to deliver the tooth. Finally, the socket will be curetted to remove all granulomatous tissue and irrigated with sterile isotonic saline solution."
16169524|NCT01628367|Device|Immediate Implant Placement|A threaded titanium alloy implant with an internal hex connection and a Resorbable Blast Texturing (RBT) surface (Tapered Internal® Implant System, Biohorizons, Inc., Birmingham, AL, USA) will be placed using a surgical guide. Implant diameter of 3.8mm with lengths of either 12 or 15mm will be used. Implants will be placed approximately 3-4mm below the free gingival margin or 2-3mm below the cemento-enamel junction of adjacent teeth.
16169525|NCT01628367|Biological|Bone Graft Placement|Circumferential defects or dehiscences around the immediately placed implant will be grafted. enCore™ Combination Allograft (Osteogenics Biomedical, Lubbock, Texas, USA) will be used as the bone graft material.
16169526|NCT01628367|Biological|Membrane placement|A non absorbable d-PTFE membrane (Cytoplast® TXT-200, Osteogenics Biomedical, Lubbock, Texas, USA) will be trimmed to an appropriate size and shape to completely cover the implant site, and extend about 3-5mm beyond on the facial aspect. The membrane will be tucked under the sub-periosteal flap. Care will be taken to ensure that the membrane is resting on bone all around the socket margins. The membrane will be kept a minimum of 1.5mm from the adjacent tooth roots in the interdental area.
16169527|NCT01628367|Biological|Collagen plug placement|A bio-absorbable collagen wound dressing (CollaPlug®, Zimmer Dental, Carlsbad, CA, USA) will be trimmed to the appropriate size, so as to cover the socket
16169528|NCT01628367|Drug|Medications|Patients will be given amoxicillin 500mg 2 days prior to the surgery and will then continue for every 8 hours for 10 days. Patients will also take Ibuprofen 600mg every 6 hours for the first 3 days following the surgery, and then as needed for pain. Patients will also receive a prescription for Vicodin as needed for pain, every 4 to 6 hours
16169529|NCT01628354|Drug|Ranibizumab|All patients will receive an intravitreal injection of ranibizumab 0.5 mg at baseline (visit 1; month 0) then a subsequent intravitreal injection at month 1 (visit 2) and month 2 (Visit 3). Patients will be reviewed every month thereafter for 12 months at which time it will be determined whether the patient requires retreatment with ranibizumab 0.5 mg based on measurements of visual acuity, Optical coherene tomography (OCT) findings and clinical appearance. A drop of vision of >5 letters or increase in retinal thickness of >100 um on OCT will trigger re-treatment as long as 14 days has elapsed since last treatment.
16169530|NCT01628341|Drug|insulin|Patients will be asked to complete 2 self-assessment questionnaires
16169531|NCT01628315|Device|MRI|Annual MRIs as part of participation in the ASA study.
16169532|NCT01628302|Behavioral|Lowering salt in diet|Low salt diet (50mmol)for three weeks.
16169533|NCT01628289|Other|charging a co-payment for Diabetic Retinopathy screening|The intervention is charging a co-payment of HK$60 for the Diabetic Retinopathy screening.
16169534|NCT01628289|Other|free screening without charging a co-payment|The intervention is to provide free screening without charging a co-payment
16169535|NCT01628276|Behavioral|Cog Rehab|Cognitive rehab for MS patients
16169536|NCT01628263|Other|Follow up Clinic for High risk participants|Families where either or both parents are screened to be at risk of PTSD or depression are randomised in a 1:1 ratio to the intervention or control arm. Those in the intervention arm will receive an offer of a follow up clinic two months post discharge, staffed by the unit Clinical Psychologist, a PICU doctor and PICU nurse. Those in the control arm will not be offered a follow up clinic.
16169537|NCT01628250|Procedure|laparoscopic complete mesocolic excision|laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized.
16169538|NCT01628250|Procedure|D3-laparoscopic colectomy|D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications.
16169539|NCT01628237|Device|comparison of spinal cord stimulation|
16169540|NCT01628211|Procedure|Laparoscopy|second look laparoscopy to evaluate for peritoneal carcinosis
16169541|NCT01628211|Procedure|peritonectomy|for patients with PCI < 20
16169542|NCT01628211|Drug|Folinic Acid|20 mg/m2 IV given just before HIPEC for patients with PCI < 20
16169543|NCT01628211|Drug|5-Fluorouracil|400 mg/m2 IV given just before HIPEC in patients with PCI < 20
16169544|NCT01628211|Drug|Oxaliplatin|460 mg/m2 intraperitoneal hyperthermic perfusion for patients with PCI < 20
16169545|NCT01628211|Drug|systemic chemotherapy|according to national Italian (AIOM) guidelines and may include biotherapies for patients with PCI > 20
16169546|NCT01628198|Device|Celcius Thermacool Catheter or Chilli II Cooled Ablation Catheter|"Saline-Irrigated Radiofrequency Ablation Catheter will be placed in the renal arteries in a circumferential manner and energy will be delivered to create 4 burn lesions.
~There are 2 devices that can be used---this is optional, based on physician preference:
~Celcius Thermacool Catheter Biosense Webster, Inc Diamond Bar, California
~or
~Chilli II Cooled Ablation Catheter Boston Scientific Corporation San Jose, California"
16169547|NCT01628185|Procedure|Repositioning|pain assessment at baseline then following routine care repositioning in bed
16169548|NCT01628172|Device|Biosense Webster Celcius Thermacool catheter|catheter-based sympathetic renal denervation
16169549|NCT01628159|Device|Lutonix Drug Coated Balloon|balloon angioplasty with a drug coated balloon
16169550|NCT01628146|Device|SUPRACOR LASIK treatment|The SUPRACOR algorithm uses the subjective refraction of the eye to create a treatment for the distance vision correction.
16169551|NCT01628133|Procedure|ultrasound|sonographic evaluation of intestinal blood flow
16169552|NCT01628120|Biological|Epoetin Hospira|Subcutaneous(SC) injection
16169553|NCT01628107|Biological|Epoetin Hospira|Intravenous (IV) injection
16169554|NCT01628094|Drug|RO5024048|
16169555|NCT01628094|Drug|RO5190591|
16169556|NCT01628094|Drug|RO5466731|
16169557|NCT01628094|Drug|ribavirin [Copegus]|
16169558|NCT01628094|Drug|ritonavir|
16169559|NCT01628081|Dietary Supplement|Alga Dunaliella Bardawil placebo|"Dosage Regimen and Treatment Groups
~Daily oral administration of:
~Dunaliella, 6 capsules/day (3 capsules in the morning, 3 in the evening).
~Placebo, 6 capsules/day (3 capsules in the morning, 3 in the evening)."
16169560|NCT01628081|Dietary Supplement|Dunaliella Bardawil|"Dosage Regimen and Treatment Groups
~Daily oral administration of:
~Dunaliella, 6 capsules/day (3 capsules in the morning, 3 in the evening).
~Placebo, 6 capsules/day (3 capsules in the morning, 3 in the evening)."
16169561|NCT01628068|Device|Left atrial appendage occlusion|Left atrial appendage occlusion with Amplatzer device plus aspirine plus clopidogrel during 3 months
16169562|NCT01628055|Biological|Privigen|10% liquid intravenous immunoglobulin at a single dose of 1.0g/kg, run at 0.5ml/kg/hr for the first 30 minutes, then increased to 2.5ml/kg/hr until complete (~3-4 hours depending on weight).
16169563|NCT01628055|Other|Normal Saline|"Normal Saline is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment. It contains no antimicrobial agents. The pH is 5.0 (4.5 to 7.0).
~It contains 9 g/L Sodium Chloride with an osmolarity of 308 mOsmol/L and 154 mEq/L Sodium and Chloride.
~The infusion will start at 0.5 ml/kg/hr for the first 30 minutes and then increased to 2.5 ml/kg/hr for 3-4 hours."
16169564|NCT01628042|Drug|Vibegron 100 mg|Vibegron tablets, orally, on Day 1
16169565|NCT01628029|Other|Counseling|Undergo CBT
16169566|NCT01628029|Drug|Methylphenidate Hydrochloride|Given PO
16169567|NCT01628029|Procedure|Phototherapy|Undergo light therapy
16169568|NCT01628029|Other|Placebo Administration|Given PO
16169569|NCT01628029|Other|Quality-of-Life Assessment|Ancillary studies
16169572|NCT01628016|Behavioral|a word dot-probe task for training procedure|In the word dot-probe task for training procedure of attention bias modification, 90% of the targets appeared at the neutral word position and 10% at the sad word position.In the placebo condition, the targets appeared with equal probability in the sad (50%) and neutral (50%) word positions.All participants in ABM and placebo conditions received eight 12-min training sessions over a 2-week period.During each session, participants completed 216 word dot-probe trials.
16169573|NCT01628003|Device|Brain MRI|Brain MRI
16169574|NCT01628003|Device|MRI|Physical examination Neuropsychological testing Questionnaires
16169575|NCT01627977|Other|Dye of Lutein, Zeaxanthin and Brilliant Blue|dye composed of Lutein, Zeaxanthin and Brilliant Blue will be used during the vitrectomy surgery to dye the membranes
16169576|NCT01627951|Other|NF54|Volunteers will be infected with the NF54 strain of Plasmodium falciparum through the bites of 5 infected Anopheline mosquitoes.
16169577|NCT01627951|Other|NF135|Volunteers will be infected with the NF135 strain of Plasmodium falciparum through the bites of 5 infected Anopheline mosquitoes.
16169578|NCT01627951|Other|NF166|Volunteers will be infected with the NF166 strain of Plasmodium falciparum through the bites of 5 infected Anopheline mosquitoes.
16169579|NCT01627938|Drug|Dexrazoxane (DRZ) plus Mitoxantrone (MX)|Dosage: DRZ (600 mg/m2) : MX (12 mg/m2) ratio 50:1 DRZ infusion / MX infusion once every three months over a period of 12 months, i.e. 5 infusions
16169580|NCT01627938|Drug|Placebo plus Mitoxantrone (MX)|MX Dosage: 12mg/m2 Placebo infusion / MX infusion once every three months over a period of 12 months, i.e. 5 infusions
16169581|NCT01627925|Device|nasal mask and continuous positive airway pressure|nasal mask use instead of face mask application of continuous positive airway pressure during induction of general anesthesia
16169582|NCT01627912|Other|Robola, Cabernet Sauvignon wines|4 treatments on separate days: the subjects randomly consumed 4ml of drink [white wine or red wine or 12.5% ethanol or water]/kg of individual, parallel with a standardized meal.
16169583|NCT01627899|Device|One Touch VerioIQ Blood Glucose Monitor|BGM with pattern alert technology and with associated pattern guide
16169584|NCT01627886|Drug|Ibandronate sodium|Ibandronate sodium Tablets 150 mg
16169585|NCT01627873|Drug|Remifentanil|In group A induction of anesthesia will be performed with Propofol (2mg/kg), Cisatracurium (0.15mg/kg)and continous infusion of Remifentanil (0.15mcg/kg/min).Anesthesia will be maintained by Sevoflurane with oxygen (Fi=40%)and air, with a MAC value to maintain BIS between 40 and 60. Intraoperative analgesia will be obtained with Remifentanil 0.15-0.25mcg/kg/min. Additional boluses of Cisatracurium (0.02mcg/kg)will be administered as needed during surgery. At the beginning of closure of the peritoneum bolus of morphine (0.1mg/kg)and acetaminophen 1g will be administered. Propofol and remifentanil infusions will be interrupted at the end of wound closure.
16169586|NCT01627873|Drug|Fentanyl|In group B anesthesia will be induced by Propofol (2mg/kg), Fentanyl (2mcg/kg)and Cisatracurium (0.15mg/kg). Anesthesia will be maintained by Sevoflurane, oxygen (Fi=40%) and air and boluses of Fentanyl (50mcg). additional boluses of Cisatracurium (0.02mg/kg)will be administered as needed during surgery. At the beginning of closure of the peritoneum acetaminophen 1g will be administered.
16169587|NCT01627860|Drug|Topiramate add-on therapy|Type=range, unit=mg/day, number=25-200, form=tablet, route=oral use.
16169588|NCT01627860|Drug|Topiramate monotherapy|Type= range, unit= mg/day, number= 25-200, form= tablet, route= oral use.
16169589|NCT01627847|Drug|Ropinirole|
16169590|NCT01627834|Drug|Ropinirole|
16169591|NCT01627821|Device|Jarvik 2000 VAS|Jarvik 2000 LVAD
16169592|NCT01627821|Device|HeartMate II|HeartMate II LVAD
16169593|NCT01627795|Drug|Oshadi D and Oshadi R|anti cancer agents
16169594|NCT01627782|Drug|Placebo|Form= intravenous infusion, route= intravenous (IV) use. IV infusions of placebo 2 times weekly or IV infusions of placebo 3 times weekly.
16169595|NCT01627782|Drug|Ketamine|Type= exact number, unit= mg/kg, number= 0.5, form= intravenous infusion, route= intravenous (IV) use. IV infusions of ketamine 0.50 mg/kg, 2 times weekly or IV infusions of ketamine 0.50 mg/kg, 3 times weekly.
16169596|NCT01627756|Other|Lung Ventilation|In the ventilated group, mechanical ventilation was done with the half of the initial tidal volume (i.e. 3-4 ml/kg, 250-300ml) during the aortic cross-clamp.
16169597|NCT01627756|Other|Non-ventilated Group|. In the non-ventilated group lungs were collapsed after completion of CPB until after weaning from the extracorporeal circulation.
16169598|NCT01627730|Other|pretest and posttest scores|pretest and post-test scores are calculated for relative growth scores
16169599|NCT01627717|Drug|Maraviroc (5 days)|Subjects will receive maraviroc 150 mg tablets (1 tablet) every 12 hours from days 1 to 5 inclusively.
16169600|NCT01627717|Drug|Maraviroc and boceprevir (14 days)|From days 6 to 19, inclusively, boceprevir 800 mg (4 capsules of 200 mg) every 8 hours with food will be given with maraviroc 150 mg (1 tablet of 150 mg) every 12 hours.
16169601|NCT01627704|Drug|Fluoroestradiol (18F)|2-4 MBq/kg body mass, one single IV injection
16169602|NCT01627691|Device|Lotus Valve System|"bioprosthetic bovine pericardial aortic valve
~delivery system"
16169603|NCT01627678|Drug|Vacc-C5/GM-CSF|Arm 1=Arm A: Vacc-C5 with GM-CSF as adjuvant administered intradermally.
16169604|NCT01627678|Drug|Vacc-C5/Alhydrogel|Arm 2=Arm B: Vacc-C5 with Alhydrogel as adjuvant administered intramuscularly.
16169605|NCT01627665|Drug|D->R->C+R|one oral dose DABIGATRAN 300 mg -> RIVAROXABAN 40 mg -> 1g/day CLARITHOMYCINE with RIVAROXABAN 40 mg
16169606|NCT01627665|Drug|D->R->C+D|one oral dose DABIGATRAN 300 mg -> RIVAROXABAN 40 mg -> 1g/day CLARITHOMYCINE with one oral dose DABIGATRAN 300 mg
16169607|NCT01627665|Drug|R->D->C+D|RIVAROXABAN 40 mg -> one oral dose DABIGATRAN 300 mg -> 1g/day CLARITHOMYCINE with one oral dose DABIGATRAN 300 mg
16169608|NCT01627665|Drug|R->D->C+R|RIVAROXABAN 40 mg -> one oral dose DABIGATRAN 300 mg -> 1g/day CLARITHOMYCINE with RIVAROXABAN 40 mg
16169609|NCT01627652|Other|altitude|the subjects will live one month at 3450 m altitude in the Jungfraujoch Research Station
16169610|NCT01627639|Drug|Acetazolamide|Acetazolamide (1 g IV per day or 2 g IV per day if coprescription of loop diuretics) or Placebo (saline serum) when pure or mixed metabolic alkalosis being present until planned extubation
16169611|NCT01627639|Drug|Placebo|Placebo
16169612|NCT01627626|Drug|Pilocarpine|"0.1% pilocarpine solution which diluted 2% pilocarpine hydrochloride eyedrop with 0.9% saline.
~subjects were instructed to mouthwash with 10ml of solution for 1 minute."
16169614|NCT01627613|Drug|AP301|"AP301 25 mg powder for reconstitution for solution for inhalation
~Orally delivered doses of 87.6 mg AP301 are inhaled every 12 hours (± 30 min), for a total of 7 days."
16169615|NCT01627613|Drug|Saline solution|Placebo solution (0.9% physiologic NaCl) is inhaled every 12 hours (± 30 min), for a total of 7 days.
16169616|NCT01627587|Drug|GSK221149 750 mg|Treatment A: 750 mg GSK221149 single dose
16169617|NCT01627587|Drug|Ketoconazole|Treatment B: 400 mg of Ketoconazole single dose
16169618|NCT01627587|Drug|GSK221149 100 mg|Treatment C: 100mg of GSK221149 single dose
16169619|NCT01627587|Drug|GSK221149 750 mg Fasted|Treatment D: 750 mg of GSK221149 administered fasted
16169620|NCT01627587|Drug|GSK221149 750 mg + Food|Treatment E: 750 mg of GSK221149 administered with a high fat meal
16169621|NCT01627574|Behavioral|Motivational Intervention|There are two, 45-60 minutes sessions of tailored MI that occur at the enrollment of the study, and at 3 month follow-up.
16169622|NCT01627574|Behavioral|Didactic Educational Intervention|There are two, 45-60 minute didactic sessions designed to provide information and awareness for sexual health involving contraception and STI prevention. The first session occurs after enrollment in the study, the second at 3 month follow-up.
16169623|NCT01627561|Biological|Cervarix|2 doses administered intramuscularly in the deltoid muscle of the left arm at Day 0 and Month 6.
16169624|NCT01627561|Biological|Priorix|1 dose administered intramuscularly in the deltoid muscle of the left arm at Day 0.
16169625|NCT01627561|Biological|Infanrix|1 dose administered intramuscularly in the deltoid muscle of the left arm at Month 6.
16169626|NCT01627548|Behavioral|Structured Approach Therapy|The SAT treatment is provided in 12 weekly 50-minute sessions and is fully manualized. First, couple-based exposure techniques are used to address anxiety about intimacy, increasing the traumatized person's ability to engage in social and relational behaviors that promote bonding and satisfaction. Second, as anxiety decreases, couple-based techniques are also used to increase the positive experiences the couple is having. These activities expose the traumatized person to positive feelings instead of anxiety, so that he/she may become desensitized to the anxiety caused by the closeness, and more comfortable engaging in intimate behaviors.
16169627|NCT01627535|Other|Interoperative Optical Imaging and Spectroscopy|Real time processing and display of i2DOS maps in the operating arena
16169628|NCT01627522|Procedure|TURP|Transurthral resection of prostate
16169629|NCT01627483|Other|Medication review|Assessment of risks of falls and fractures; medication review concerning fall-risk-increasing and fracture-preventing drugs; oral and written feed back of the results of the assessments and medication reviews to the hospital physician during the hospital stay and to the general practitioner 3 and 6 months after the hip fracture surgery.
16169630|NCT01627470|Device|CNAP-Monitor|Continuous non-invasive arterial blood pressure recording
16169631|NCT01627457|Device|Guided Exercise (GEx) system|30 CAD patients will wear the GEx system while they are trained during inpatient cardiac rehabilitation (phase II) in order to evaluate accuracy and safety of data like heart rate, breathing, ECG three times a week for about three weeks. In a second step these patients train at home (phase III) in order to evaluate practicability and technical problems of the GEx device three times a week for about three weeks.
16169632|NCT01627444|Procedure|Ear acupuncture|Ear acupuncture based on Chinese Map: ShenMen, Anxiety 1 and 2, Tension, Muscular relaxation.
16169633|NCT01627431|Drug|Acetylsalicylic acid|100 mg once per day
16169634|NCT01627431|Drug|Clopidogrel|75 mg once per day
16169635|NCT01627418|Behavioral|Energy Voucher|Receive the intervention the first winter enrolled in the study. The intervention is a electricity voucher and a short pamphlet describing how to work out how much heat the voucher can buy.
16169636|NCT01627418|Behavioral|No intervention : control arm|Do not receive the money or pamphlet in the initial study year
16169637|NCT01627392|Behavioral|Smoking abstinence|6 hour smoking abstinence
16169638|NCT01627379|Drug|Cisplatin, 5-FU|"Arm A: Cisplatin 80 mg/m2 IV infusion over 2 hours on Day 1, followed by 5-FU 1000 mg/m2 IV daily as continuous infusion over 24 hours, Day 1-4.
~Chemotherapy will be administered every 3 weeks until progression of disease or any other reason for treatment withdrawal is fulfilled."
16169639|NCT01627379|Drug|Panitumumab|"Arm B: Cisplatin 80 mg/m2 IV infusion over 2 hours on Day 1, followed by 5-FU 1000 mg/m2 IV daily as continuous infusion over 24 hours, Day 1-4.
~Panitumumab will be administered on Day 1 of each treatment cycle at a dose of 9 mg/kg prior to administration of chemotherapy.
~Each treatment cycle is defined as 21 days. Patients are treated until progression of disease occurs or any other reason for treatment withdrawal is fulfilled."
16169640|NCT01627366|Other|Survivorship Care Plan|Receipt of a personalized survivorship care plan and an in-person session with a trained nurse to review the contents of the care plan.
16169641|NCT01627353|Procedure|Standard of care|Current Standard of Care at Rockyview General Hospital for Post Hysterectomy Pain Prevention(no wound infiltration and routine anesthetic protocol).
16169642|NCT01627353|Procedure|Pre-emptive wound infiltration|"The Wound Infiltration Group will receive 100 mL 0.125% marcaine plain distributed as follows: 50 mL subcutaneously prior to skin incision along entire length of planned incision line, 50 mL subfascially prior to fascial incision, with 10 mL infiltrated directly into the rectus muscles bilaterally.
~The Anesthetic will be given as determined appropriate to the patient by the staff anesthetist with the addition of the following: 2 grams of Magnesium Sulphate, 10 mg of Dexamethasone, and 3 mg/kg of Lidocaine, half of which is given on induction and half of which is infused throughout the remainder of the case."
16169643|NCT01627340|Biological|Engerix™-B vaccine|3 doses administered intramuscularly (IM) in the deltoid region of the non-dominant arm.
16169644|NCT01627327|Drug|fluticasone furoate/vilanterol 100/25mcg|inhalation powder
16169645|NCT01627327|Drug|tiotropium bromide 18mcg|inhalation powder
16169646|NCT01627314|Biological|ProHema-CB|Ex-vivo CXCR4 upregulated hematopoietic progenitor cells, cord blood
16169647|NCT01627314|Biological|Untreated CB|Cord Blood
16169681|NCT01627054|Drug|AT7519M|Dose: 27 mg/m2, IV injection, 1 hour infusion Schedule: 27 mg/m2/day twice weekly x 2 weeks every 3 weeks (days 1, 4, 8 and 11)
16169682|NCT01627041|Drug|Cytarabine|Given IV
16169683|NCT01627041|Drug|Daunorubicin Hydrochloride|Given IV
16169684|NCT01627041|Drug|Decitabine|Given IV
16169685|NCT01627041|Other|Laboratory Biomarker Analysis|Correlative studies
16169648|NCT01627301|Device|Device-Guided Breathing (DGB)|The RESPeRATE device will be used for 15 minutes of device-guided breathing daily for 8 weeks. The participant places the elastic belt with a respiration sensor around the upper abdomen, and wears earbuds for audio feedback. The device monitors the breathing rate, calculates inspiration and expiration times, and generates a personalized melody of two distinct ascending and descending tones for inhalation versus exhalation. Users effortlessly entrain their breathing pattern with the tones, and the device gradually guides the user to a prolonged expiration time and slower respiratory rate (to < 10 breaths/minute). The device automatically stores usage data, allowing for quantification of adherence and performance.
16169649|NCT01627301|Device|Sham DGB|The sham device is identical to the DGB device, except it does not guide respiratory rates to slow down and instead maintains a rate of 14 breaths per minute. The sham device is used for 15 minutes per day for 8 weeks.
16169650|NCT01627301|Device|Transcutaneous Vagal Nerve Stimulation (tVNS)|tVNS is a noninvasive method that involves placing a device over the skin overlying the vagus nerve on the neck. The device delivers mild electrical stimulation, using transcutaneous electrical nerve stimulation (TENS) unit. The stimulation is increased until there is a vibration and slight muscle contraction in the lower face or neck. Then the stimulation is delivered for 2 minutes on the left side of the neck, and on the right side of the neck, for a total of 4 minutes. The tVNS device is used twice daily for 8 weeks.
16169651|NCT01627301|Device|Sham tVNS|Sham stimulation is delivered using a device that is identical to the gammaCore device but is programed to deliver a lower frequency that can be felt by the participant but does not actually stimulate the vagus nerve. The sham device is used twice daily for 8 weeks.
16169652|NCT01627288|Radiation|Boost radiation|Many studies have utilized a sequential boost to deliver a total dose of 55 - 60 Gy to the pelvic sidewall (covering the lower pelvic lymph nodes), including 8-10 Gy that is usually delivered with brachytherapy (1-3). This study treatment plan will escalate the dose to pelvic and para-aortic nodal disease from 60 Gy in 2.4 Gy per fraction to 70Gy in 2.8 Gy per fraction in 3 dose cohorts, using an integrated boost technique utilizing the same number of fractions for all cohorts (25 fractions) while the elective volumes are held constant at 45Gy
16169653|NCT01627275|Biological|Naive T Cell Depleted Donor Lymphocyte Infusion|A single naive T-cell depleted donor lymphocyte infusion will be administered through a peripheral or central venous catheter greater than or equal to 60 days post allogeneic hematopoietic stem cell transplant.
16169654|NCT01627262|Drug|Mesalamine|3x1000mg mesalamine granules per day
16169655|NCT01627262|Drug|Placebo|3x1000mg placebo granules per day
16169656|NCT01627249|Drug|2.0 mg intravitreal aflibercept|Intravitreal injection of 2.0 mg aflibercept at baseline and up to every 4 weeks using defined retreatment criteria.
16169657|NCT01627249|Drug|1.25 mg intravitreal bevacizumab|Intravitreal injection of 1.25 mg bevacizumab at baseline and up to every 4 weeks using defined retreatment criteria.
16169658|NCT01627249|Drug|0.3 mg intravitreal ranibizumab|Intravitreal injection of 0.3 mg ranibizumab (Lucentis™) at baseline and up to every 4 weeks using defined retreatment criteria.
16169659|NCT01627236|Drug|methylprednisolone|methylprednisolone 1mg/kg intravenous drip qd，for 3 days glucocorticoid
16169660|NCT01627223|Drug|Lamivudine|"Lamivudine 100 mg p.o. q.d.
~This process will be stratified by prolonged PT, < 4 sec / 4-6 sec / > 6 sec. Both lamivudine and entecavir will be taken once daily and the first dose of observational drug should be administered on Day 1. The observational period of individual subject will be 12 weeks; however, both treatments could be continued after the end of study based on physician's clinical judgment."
16169661|NCT01627223|Drug|Entecavir|"•Entecavir 0.5 mg p.o. q.d
~This process will be stratified by prolonged PT, < 4 sec / 4-6 sec / > 6 sec. Both lamivudine and entecavir will be taken once daily and the first dose of observational drug should be administered on Day 1. The observational period of individual subject will be 12 weeks; however, both treatments could be continued after the end of study based on physician's clinical judgment."
16169662|NCT01627197|Procedure|Surgery of percutaneous catheter system|Intraarterial (IA) catheterization was done in the Department of Invasive Technology. All medications were administered using percutaneous catheter system via a modified Seldinger technique. An angiographic catheter was inserted through the femoral artery into the internal iliac artery. The catheter tips were located superior to the origin of bilateral common artery.
16169663|NCT01627184|Device|Dexcom G4 CGM System|
16169664|NCT01627171|Drug|Bisacodyl 10mg|Given at the start of the bowel preparation the day before colonoscopy
16169665|NCT01627171|Drug|Polyethelene Glycol|280g reconstituted in 4 liters of water
16169666|NCT01627171|Drug|Picosulfate sodium|Two sachets, Each sachet has 10mg dose
16169667|NCT01627158|Drug|Budesonide/formoterol Easyhaler|Budesonide/formoterol Easyhaler
16169668|NCT01627158|Drug|Symbicort Turbuhaler|Symbicort Turbuhaler
16169669|NCT01627158|Drug|Charcoal and Budesonide/formoterol Easyhaler|Charcoal and Budesonide/formoterol Easyhaler
16169670|NCT01627158|Drug|Charcoal and Symbicort Turbuhaler|Charcoal and Symbicort Turbuhaler
16169671|NCT01627145|Drug|Solifenacin|Solifenacin 5 mg qd,
16169672|NCT01627132|Drug|Dasatinib|100mg QD
16169673|NCT01627106|Drug|Vernakalant|Initial intravenous (IV) dose of 3 mg/kg (up to a maximum of 339 mg) over 10 minutes, followed by a 15 minute observation period and, if conversion to sinus rhythm does not occur within 15 minutes of the initial infusion, a second 10 minute infusion of vernakalant at a dose of 2 mg/kg (up to a maximum of 226 mg) will be administered.
16169674|NCT01627106|Drug|Amiodarone|Administered IV as per product label
16169675|NCT01627093|Other|Medical Chart Review|Review of medical records
16169676|NCT01627093|Other|Questionnaire Administration|Complete questionnaires
16169677|NCT01627080|Other|Cardiac Biomarker Blood Draws|Blood (about 1 teaspoon) drawn to measure cardiac biomarkers at the following time points: within 12-24 hours of the start of radiation, one (1) time during the third week of radiation, within 48 hours after completion of radiation, and about 1 to 2 months after completion of radiation therapy.
16169678|NCT01627067|Drug|Everolimus|10 mg by mouth once daily.
16169679|NCT01627067|Drug|Exemestane|25 mg by mouth once daily.
16169680|NCT01627067|Drug|Metformin|500 mg by mouth per day for three days. If there are no dose limiting toxicities, the dose of metformin will be increased by 500 mg orally every three days to reach the target dose of 1,000 mg orally twice daily.
16169686|NCT01627041|Other|Pharmacological Study|Correlative studies
16169687|NCT01627028|Procedure|Thai traditional massage|two hours of Thai traditional massage twice a week for 4 weeks
16169688|NCT01627015|Other|Modified infant follow-on formula|The modified infant follow-on formula has a different carbohydrate pattern than the standard formula
16169689|NCT01627015|Other|Standard infant follow-on formula|Infants are fed a commercial follow-on formula
16169690|NCT01627002|Biological|PA401|Part A of Study: Subcutaneous, 0.1mg to 50mg, single ascending doses Part B of Study: Subcutaneous, up to 17.1mg, single dose
16169691|NCT01627002|Other|Placebo|Subcutaneous
16169692|NCT01626989|Device|BiPAP auto Advanced|Auto Servo Ventilation Device
16169693|NCT01626989|Device|BiPAP auto SV4|Auto Servo Ventilation Device
16169694|NCT01626976|Drug|PF-06282999|Solution, doses range from 20 to 200 mg, single dose
16169695|NCT01626976|Drug|Placebo|Solution, single dose
16169696|NCT01626976|Drug|PF-06282999|Methylcellulose suspension, doses range 125 to 500 mg, single dose
16169697|NCT01626976|Drug|Placebo|suspension, single dose
16169698|NCT01626976|Drug|PF-06282999|Methylcellulose or simethicone suspension, doses range 200 to 500 mg, single dose
16169699|NCT01626976|Drug|Placebo|suspension, single dose
16169700|NCT01626976|Drug|PF-06282999|Methylcellulose or simethicone suspension, 500 mg dose, single dose
16169701|NCT01626976|Drug|Placebo|suspension, single dose
16169702|NCT01626976|Drug|PF-06282999|Simethicone or methylcellulose suspension, up to 1500 mg, single dose
16169703|NCT01626976|Drug|Placebo|suspension, single dose
16169704|NCT01626963|Procedure|Single-port access surgery|Surgery carried out through a single incision laparoscopic approach
16169705|NCT01626963|Procedure|Conventional Laparoscopic Access|Surgery through standard multiport laparoscopic approach
16169706|NCT01626937|Other|Non invasive ventilation|After nebulisation of bronchodilatators and administration of corticosteroid therapy, non invasive positive pressure ventilation will be started out of hospital and continuously in COPD patient with acute respiratory distress and respiratory acidosis, using a facial mask, with initial level of inspiratory pressure at 8 mmHg then according to VTe and/or respiratory rate; expiratory pressure at 4 mmHg then according to persistance of inspiratory work, level of FiO2 for an objective of SpO2 between 88 and 92%. In case of failure, NIV will be stopped and endotracheal intubation realized if indicate.
16169707|NCT01626937|Other|conventional medical treatment|Conventional medical treatment includes nebulization of bronchodilatators every 15-20 minutes until hospital and corticosteroid therapy. If indicate during out of hospital setting, endotracheale intubation will be realized. After admission in hospital, non invasive ventilation could be started.
16169708|NCT01626924|Drug|2-Iminobiotin|2-Iminobiotin is formulated as a 0.75 mg/ml isotonic, iso-osmotic, saline solution with a pH of 4. It is administered as a solution for I.V.infusion through a central catheter. Six pulse doses will be given in 20 hours. Dosage will starts with 0.2 mg/kg/dose, but may be adapted during the study.
16169709|NCT01626911|Procedure|Continuous regional arterial infusion of low molecular weight heparin in celiac trunk|Put a catheter to the celiac trunk through interventional technique. The approach to celiac trunk was via a femoral artery approach.The tip of the arterial catheter (4F) was placed in celiac trunk which could perfuse the pancreas.After that, continuous infusion of low molecular weight heparin through the catheter will be applied during the first 5 days after placement.
16169710|NCT01626911|Other|General treatment|Include fluid resuscitation, percutaneous drainage if needed, antibiotics,organ support, etc.
16169711|NCT01626898|Behavioral|HOLA en Grupos|HOLA en Grupos consists of four 4-hour group sessions that combine presentations by facilitators who are trained Latino MSM community members, activities, and scenes from a DVD, and is delivered over a period of two weeks to groups of about 10 participants. HOLA en Grupos is designed to increase HIV prevention knowledge, condom use and mastery, decrease barriers to risk reduction (e.g., health-compromising aspects of machismo), enhance sexual negotiation skills, and increase use of HIV testing, counseling, and treatment services among intervention participants.
16169712|NCT01626898|Behavioral|General Health intervention (comparison intervention )|The Spanish comparison condition consists of four Spanish-language 4-hour group sessions designed to increase participants' knowledge about cancer, diabetes, alcohol abuse, and cardiovascular disease, and is delivered over a period of two weeks to groups of about 10 participants.
16169713|NCT01626885|Drug|MP-214|Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg) of MP-214 for four weeks, then flexible dose (1.5-9 mg) of MP-214
16169714|NCT01626872|Drug|MP-214 3mg|In the double-blind period (before Week 6), participants continue in the same arm they were on in core trial A002-A4 (except placebo arm starts 3mg or 6mg of MP-214). In the open-label period (after Week 6), patients will be rerandomized to 3mg or 6mg of MP-214. After the fourth week of the open-label treatment period, they will be received MP-214 at flexible doses (3mg or 6mg or 9mg).
16169715|NCT01626872|Drug|MP-214 6mg|In the double-blind period (before Week 6), participants continue in the same arm they were on in core trial A002-A4 (except placebo arm starts 3mg or 6mg of MP-214). In the open-label period (after Week 6), patients will be rerandomized to 3mg or 6mg of MP-214. After the fourth week of the open-label treatment period, they will be received MP-214 at flexible doses (3mg or 6mg or 9mg).
16169716|NCT01626872|Drug|MP-214 9mg|In the double-blind period (before Week 6), participants continue in the same arm they were on in core trial A002-A4 (except placebo arm starts 3mg or 6mg of MP-214). In the open-label period (after Week 6), patients will be rerandomized to 3mg or 6mg of MP-214. After the fourth week of the open-label treatment period, they will be received MP-214 at flexible doses (3mg or 6mg or 9mg).
16169717|NCT01626872|Drug|Risperidone 4mg|In the double-blind period (before Week 6), participants continue in the same arm they were on in core trial A002-A4. In the open-label period (after Week 6), patients will be rerandomized to 3mg or 6mg of MP-214. After the fourth week of the open-label treatment period, they will be received MP-214 at flexible doses (3mg or 6mg or 9mg).
16169718|NCT01626859|Drug|MP-214 3mg|Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for twelve weeks.
16169719|NCT01626859|Drug|MP-214 6mg|Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for twelve weeks.
16169720|NCT01626859|Drug|MP-214 9mg|Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for twelve weeks.
16169758|NCT01626573|Drug|Itacitinib Placebo|
16169759|NCT01626560|Drug|Daptomycin|daptomycin 4-6mg/kg qd 10 - 14 days
16169721|NCT01626833|Drug|SOMATROPINE* : Norditropine® simplexx®|SOMATROPINE* : Norditropine® simplexx® - 15 mg/1,5 ml, injectable solution:Treatment with hGH is administered at a dose of 0.05 mg / kg / day (0.35 mg / kg / week) subcutaneously daily, preferably in the evening. The dose of hGH treatment will be adjusted according to weight gain, and reduced by 10% if the serum values of IGF-I SDS above 2.5 on 2 consecutive determinations at 3-month intervals are discovered by the biologist.
16169722|NCT01626833|Biological|Placebo|Treatment with placebo is administered at a dose of 0.05 mg / kg / day (0.35 mg / kg / week) subcutaneously daily, preferably in the evening. The dose of placebo will be adjusted according to weight gain, and reduced by 10% if the serum values of IGF-I SDS above 2.5 on 2 consecutive determinations at 3-month intervals are discovered by the biologist.
16169723|NCT01626820|Biological|Fluviral®|1 dose administered intramuscularly in deltoid region of non-dominant arm at Day 0
16169724|NCT01626807|Behavioral|Walking School Bus|Children will have the option of walking to and/or from school with study staff who are trained in Safe Routes to School methods.
16169725|NCT01626794|Biological|VARIVAX™ VEP|Two 0.5 mL subcutaneous doses administered on Days 1 and 91
16169726|NCT01626794|Biological|VARIVAX™ 2007 Process|Two 0.5 mL subcutaneous doses administered on Days 1 and 91
16169727|NCT01626794|Biological|M-M-R™ II|Two doses administered on Days 1 and 91 concomitantly with VARIVAX™ VEP or VARIVAX™ 2007 Process
16169728|NCT01626781|Device|Mapisal|Mapisal® ointment will be applied to hand and feet three times daily, as well as after washing hands. Treatment should start 2 days prior to the first chemotherapy cycle with capecitabine and will continue daily for the first 6 weeks of chemotherapy.
16169729|NCT01626781|Other|Urea hand-foot cream|Urea hand-foot cream will be applied to hand and feet three times daily, as well as after washing hands. Treatment should start 2 days prior to the first chemotherapy cycle with capecitabine and will continue daily for the first 6 weeks of chemotherapy.
16169730|NCT01626755|Procedure|Sciatic name block|Ultrasound-guided sciatic nerve block.
16169731|NCT01626742|Other|Ready to Drink Flavored Beverage|2 servings a day
16169732|NCT01626742|Other|Ready to drink flavored beverage w/ AN 777|2 servings a day
16169733|NCT01626729|Behavioral|Traffic Light|A kilocalories (calories) per serving label and a Traffic Light symbol with High/Med/Low text indicating amounts of saturated fat, total sugars, and sodium per serving.
16169734|NCT01626729|Behavioral|Traffic Light+|A calories per serving label and a Traffic Light symbol with High/Med/Low text indicating amounts of saturated fat, total sugars, sodium, fiber and protein per serving.
16169735|NCT01626729|Behavioral|Facts Up Front|A label displaying calories, saturated fat, sodium, and total sugars per serving. Nutrient amounts were listed in grams/milligrams and % Daily Values (%DVs), which indicate whether a serving of food is high or low in a nutrient based on daily value recommendations for a 2,000 calorie diet, were included. This symbol was created based on the Facts Up Front symbol description provided by the Grocery Manufacturers Association and Food Marketing Institute, without the inclusion of nutrients to encourage.
16169736|NCT01626729|Behavioral|Facts Up Front+|A label displaying calories, saturated fat, sodium, and total sugars per serving. The label also showed two (out of the possible eight) nutrients to encourage with the highest %DV. Nutrient amounts were listed in grams/milligrams and %DVs were included. This symbol was based directly on the Facts Up Front symbol description provided by the Grocery Manufacturers Association and Food Marketing Institute.
16169737|NCT01626729|Behavioral|No label control group|No label control group
16169738|NCT01626716|Other|care management|patients who assigned to the intervention group will take 7 times phone calls from case manager
16169739|NCT01626703|Other|Reminding call|
16169740|NCT01626690|Device|Bair-Paws Warming Device|Bair-Paws device to be applied to patient and used for perioperative (including preoperative) warming.
16169741|NCT01626690|Device|Bair-Hugger Warming Device|Bair-Hugger device to be applied to patient and used for intraoperative warming (current standard of care at our institution).
16169742|NCT01626677|Biological|CARTISTEM|A single dose of 500㎕/㎠ of cartilage defect
16169743|NCT01626677|Procedure|Microfracture|Active control
16169744|NCT01626664|Biological|KW-0761|1.0 mg/kg weekly x 4 in cycle 1 then every other week until progression
16169745|NCT01626664|Drug|Pralatrexate|30 mg/m2 weekly for 3 weeks followed by 1 week of no therapy until progression
16169746|NCT01626664|Drug|gemcitabine plus oxaliplatin|gemcitabine 1000 mg/m2, followed by oxaliplatin 100 mg/m2 every 2 weeks until progression
16169747|NCT01626664|Drug|DHAP|dexamethasone 40 mg on Day 1-4, cisplatin 100 mg/m2 on Day 1 followed by 2 doses of cytarabine 2000 mg/m2 every 4 weeks until progression
16169748|NCT01626651|Drug|Ibrutinib|A single oral dose of 120 mg ibrutinib (3 x 40 mg capsules) on Day 1, and 40 mg (1x 40 mg capsule) ibrutinib on Day 7.
16169749|NCT01626651|Drug|Ketoconazole|Ketoconazole (400 mg [2 x 200 mg] once daily) will be orally administered on Days 4, 5, 6, 7, 8 and 9.
16169750|NCT01626638|Procedure|Confocal Micro Endoscopy|
16169751|NCT01626625|Drug|stem cells + hydroxy apatite|patient will be transplanted with stem cells and hydroxyapatite
16169752|NCT01626625|Other|autograft taken from iliac crest|patient will be transplanted with autograft
16169753|NCT01626612|Procedure|continuation of the empirical antimicrobial therapy|ALL THE ANTIBACTERIAL IN WORN SYSTEMATIC
16169754|NCT01626612|Procedure|streamlining of the empirical antimicrobial therapy|ALL THE ANTIBACTERIAL IN WORN SYSTEMATIC
16169755|NCT01626599|Device|ProGuardian|"The investigational system is composed of a sensor, patch, hub, and caregiver application. The sensor is applied externally during periods of nocturnal sleep for up to 7 nights.
~The investigational system:
~is not implantable and no surgical procedure is required for a human subject to use the devices;
~is not for use in supporting or sustaining a human life; and
~is not of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health.
~Contains skin-contacting materials made of medical grade materials (e.g. sold for use as surgical or wound care) with well-established biocompatibility testing profiles."
16169756|NCT01626586|Behavioral|Group Therapy|Self-management Diabetes Protocol: Successful adjustment to daily diabetes management requires a wealth of clinical knowledge, solid problem-solving and coping skills to deal with the physical, social and emotional factors associated with caring for and living with a chronic illness, and motivation to take care of one's health.
16169757|NCT01626573|Drug|Itacitinib|
16169763|NCT01626521|Other|CT pulmonary angio, blood tests|CT pulmonary angiography to determine PE and laboratory blood tests to determine prothrombin fragments F1+2 in blood of COPD patients
16169764|NCT01626495|Biological|CART-19|Day 0: 10% of total dose Day 1: 30% of total dose if patient is stable (no significant toxicity) from prior dose.
16169765|NCT01626482|Other|Kinesio Taping|"The taping consisted of two strips of material in the form of I on both sides of the lumbar spine, from the sacroiliac joint to the ipsilateral transverse process of D12."
16169766|NCT01626482|Other|Placebo|The placebo taping consisted of two 10 cm length strips of the same material, adhered transversely to the skin of the paravertebral muscles fibers
16169767|NCT01626469|Drug|Captopril|25mg Captopril
16169768|NCT01626469|Drug|placebo|placebo
16169769|NCT01626456|Drug|ALKS 9072, Low|IM injection, given monthly
16169770|NCT01626456|Drug|ALKS 9072, High|IM injection, given monthly
16169771|NCT01626443|Dietary Supplement|Myo-inositol + D-chiro-inositol + Folic acid|Myo-inositol (550 mg) + D-chiro-inositol (13.8 mg) + Folic acid (200 mcg); 2 x die
16169772|NCT01626443|Dietary Supplement|Folic acid|Folic acid (200 mcg); 2 x die
16169773|NCT01626430|Dietary Supplement|Gamma delta TRF|50g of high fat meal will be given in a form of muffin and milkshake. A 200 mg, 400 mg gamma delta TRF or placebo will be incorporated into milkshake.
16169774|NCT01626430|Dietary Supplement|Placebo|50g of high fat meal will be given in a form of muffin and milkshake. A 200 mg, 400 mg gamma delta TRF or placebo will be incorporated into milkshake.
16169775|NCT01626417|Device|Tibion Bionic Leg|The device is a lightweight, wearable, portable, battery-powered, robotic leg orthosis that provides active assistance and resistance to lower limb movement according to the patient's intent to move.
16169776|NCT01626391|Drug|TRx0237|TRx0237 tablets 250 mg/day (given as 125 mg bid) for 4 weeks
16169777|NCT01626391|Drug|Placebo|Placebo tablets will be administered twice daily (b.i.d.) for 4 weeks. The placebo tablets include 4 mg of TRx0237 as a urinary and faecal colourant to maintain blinding; hence, the placebo group will receive a total of 8 mg/day of TRx0237.
16169778|NCT01626378|Drug|TRx0237|TRx0237 100 mg tablet will be administered twice daily.
16169779|NCT01626378|Drug|Placebo|Placebo tablets will be administered twice daily. The placebo tablets include 4 mg of TRx0237 as a urinary and fecal colorant to maintain blinding; hence, the placebo group will receive a total of 8 mg/day of TRx0237.
16169780|NCT01626365|Procedure|non-thermosoftening|Intubation is performed with a double-lumen tube put into normal saline at room temperature.
16169781|NCT01626365|Procedure|thermosoftening|Intubation is performed with a double lumen tube put into warm normal saline (40°C).
16169782|NCT01626352|Drug|Bendamustine|Patients will receive as an IV infusion bendamustine 90 mg/m^2 Days 1 and 2 of Cycles 1 through 6.
16169783|NCT01626352|Drug|Ofatumumab|Patients will receive as an IV infusion ofatumumab 1000-mg IV Days 1 and 8 during Cycle 1 only, and on Day 1 of Cycles 2 through 6
16169784|NCT01626339|Drug|Intravitreal Ranibizumab|
16169785|NCT01626339|Drug|Intravitreal bevacizumab|
16169786|NCT01626326|Behavioral|San Francisco Stop Smoking iPhone app|iPhone app designed to help people quit smoking
16169787|NCT01626313|Behavioral|FOCUS Individualized Family Resiliency Training|Eight session psycho educational training for families to enhance communication and reduce stressors related to return to post-military life.
16169788|NCT01626287|Other|Frozen perineal pad|Frozen ice pads will be provided as per participants' request
16169789|NCT01626287|Other|Warm water soaked Black Tea Bags|warm water soaked black tea bags will be provided to participants' as per their request
16169790|NCT01626274|Device|LAVIMO in- ear sensor system|Long term vital signs parameters like heart rate, heart rate variability, breathing and oxygen saturation are measured via in- ear sensor system during 1 polysomnographic night
16169791|NCT01626261|Device|Magnetic and electric field´s impact on the implant|Examination of magnetic and electric field's impact on the implant regarding: stability detection threshold using different strength of magnetic and electric field
16169792|NCT01626222|Drug|Exemestane|Exemestane is supplied by Novartis until Everolimus is commercially available for the study setting. Afterwards the investigator will prescribe Exemestane according to the individual label. Commercially available Exemestane will be supplied as tablets of 25 mg strength for oral administration. Complete guidelines for management and administration of Exemestane can be found in the package insert. Exemestane will be dosed starting on treatment Day 1. Patients will be instructed to take 1 tablet of 25 mg Exemestane orally. Package insert instructions should be followed. On the first day of each cycle, patients will receive an adequate drug supply (before commercial availability) or a prescription (after commercial availability) for self-administration at home. The investigator must emphasize compliance and will instruct the patient to take Exemestane exactly as prescribed.
16169793|NCT01626222|Drug|Everolimus (RAD001)|Everolimus (RAD001) is supplied by Novartis until Everolimus is commercially available for the study setting. Afterwards the investigator will prescribe Everolimus according to the individual label. Everolimus is formulated as tablets of 10 and 5 mg strength for oral administration. All study medication will be packaged into blister packs. The blisters should be opened only at the time of administration, as the drugs are both hygroscopic and light sensitive. Everolimus will be dosed starting on treatment Day 1. Patients will be instructed to take 1 tablet × 10 mg Everolimus orally with a large glass of water once daily at the same time each day with or without food. On the first day of each cycle, patients will receive an adequate drug supply (before commercial availability) or a prescription (after commercial availability) for self-administration at home. The investigator must emphasize compliance and will instruct the patient to take Everolimus exactly as prescribed.
16169794|NCT01626209|Drug|BKM120|This is a single arm study, with a starting dose of BKM120 at 80mg/day. Two dose levels: 80mg/day and 100mg /day will be tested in the dose escalation phase. At least 3 patients will be enrolled at each dose level and at least 6 evaluable patients required to be treated at the recommended Phase II dose(RP2D)/MTD dose. After dose escalation the 80mg/day and the 100mg /day dose levels will be expanded to evaluate up to approximately a total of 15 patients each (if 100mg is determined as the RP2D/MTD).
16169795|NCT01626196|Other|No intervention|This was an observational study
16169796|NCT01626183|Genetic|RNA analysis|
16169797|NCT01626183|Genetic|proteomic profiling|
16169798|NCT01626183|Other|laboratory biomarker analysis|
16169799|NCT01626170|Other|laboratory biomarker analysis|Correlative studies
16169800|NCT01626131|Behavioral|exercise training|"Participants will engage in 3 aerobic and resistance exercise sessions (~60-75 min total per session) weekly for 8 consecutive weeks.
~Aerobic exercise will be performed for 30 minutes on a treadmill 3 times weekly. Before beginning, 10 min of stretches will be performed. Each exercise bout will begin and end with a 5-min warm-up and 5-min cool-down on the treadmill, not included in the prescribed exercise duration.
~Eight resistance exercises will be performed immediately following the aerobic exercise: lat pulldown, triceps pushdown, seated chest press, upright row, bicep curls, leg press, shoulder press, and abdominal crunches. Participants will perform two sets of 10 repetitions of each. A rest interval of 60 seconds will be taken between exercises. Research staff will initially assist the participants in choosing the proper resistance to use, and weight will be increased once 15 repetitions can be performed while maintaining proper form."
16169801|NCT01626131|Behavioral|Stretching training|Participants will engage in stretching sessions that will focus on whole-body flexibility. Participants will perform 3 sessions per week (~60 min) of 3 sets of 14 stretches focused on the muscle groups targeted by the exercise training (i.e., deltoids, pectorals, lats, forearms and biceps, triceps, quadriceps, hamstrings, and groins). Each stretch will be performed for 20 seconds and a rest interval of 60 seconds will be taken between each set.
16169802|NCT01626118|Drug|Indomethacin|capsules, 40 mg, TID
16169803|NCT01626118|Drug|Indomethacin|capsules, 40 mg, BID
16169804|NCT01626118|Drug|Indomethacin|capsules, 20 mg, TID
16169805|NCT01626118|Drug|Placebo|capsules
16169806|NCT01626092|Drug|Campath-1H|A daily dose of 0.3 mg/kg IV over 2 hours will be administered on days - 12, -11, -10, -9, and -8.
16169807|NCT01626092|Drug|Clofarabine|"A daily dose of 40 mg/m2 will be administered IV over 2 hours on days -9,
~-8, -7, -6, and -5."
16169808|NCT01626092|Drug|Melphalan|A single dose of 140 mg/m2 will be given IV on day -4 over 15 minutes.
16169809|NCT01626092|Radiation|Total Body Irradiation with Marrow Boosting|"Dose to total body 200 cGy in single dose
~Dose to bone marrow of the following bones 800 cGy in 5 divided daily fractions (160 cGy x 5 doses ). Treated with up to 3 abutting VMAT photon arcs from top of head to maximum inferior border."
16169810|NCT01626092|Biological|Hematopoietic stem cell transplantation|Patients will be transplanted using either a related or unrelated allograft. The cell source may be marrow, peripheral blood or cord blood based on donor availability.
16169811|NCT01626092|Drug|Cyclosporine A|Patients will receive CsA therapy beginning on day -3. Dosing of CsA will be 2.5 mg/kg/dose IV; if the recipient body weight is <40 kg, dosing will be 3 times daily, and if > 40 kg, twice daily. An attempt will be made to maintain a trough cyclosporine level of 200 mg/L to 400 mg/L.
16169812|NCT01626092|Drug|Mycophenolate mofetil|Patients will receive mycophenolate mofetil (MMF) therapy beginning on day -3. Dosing of MMF will be 1 gram three times daily (total daily dose 3 grams/day) if the recipient is >50 kg, or 15 mg/kg/dose three times daily if the recipient is ≤50 kg. The same dosage is used orally or intravenously.
16169813|NCT01626079|Device|MitraClip System|Percutaneous mitral valve repair using MitraClip System
16169814|NCT01626066|Drug|LUM015|LUM015 assigned dose given once by IV push
16169815|NCT01626053|Behavioral|ASMART|Motivational Interviewing, Stages of Change, Psychological Testing, Bio-psychosocial assessment, responsive diabetes education, support, Cognitive-behavioral interventions
16169816|NCT01626053|Other|Control Group|no intervention
16169817|NCT01626040|Drug|polyethylene glycol powder|A single group of children taking a polyethylene glycol powder preparation, dosage determined by patient weight, taken in one dose the day before colonoscopy
16169818|NCT01626014|Behavioral|Usual Care Educational Website|Using the control website: Participants access a website with standard ovarian cancer informational handouts.
16169819|NCT01626014|Behavioral|Prototype System|An interactive system for patients and their caregivers includes features allowing users to create their own profile, share a journal with others, and post to respective discussion forums. In addition, core intervention components include distress monitoring, educational items, details about the healthcare team and an areas to keep track of questions for providers.
16169820|NCT01626001|Procedure|4D CT scans|4 (or 5 for Cohort 2) 4DCT scans performed. 1 scan performed while breath held for less than 20 seconds. CT scans take about 5 minutes each to complete.
16169821|NCT01625988|Drug|LY2951742|
16169822|NCT01625988|Drug|Placebo|
16169823|NCT01625949|Procedure|Intracoronary stem cells injection|Intracoronary stem cells will be injected in the infarct related artery after a successful coronary dilatation and stenting autologous bone marrow stem cells from iliac crest 60 ml bone marrow will be extracted and purified for mononuclear cells which will be injected.
16169824|NCT01625949|Procedure|coronary dilatation and stenting|coronary dilatation and stenting
16169825|NCT01625936|Drug|CRLX101 (Cerulean)|CRLX101 is an innovative tumor-targeting nanopharmaceutical.
16169826|NCT01625936|Drug|Bevacizumab|
16169827|NCT01625923|Drug|Olanzapine|Subjects will initially start on olanzapine 2.5 mg per mouth daily. Subjects will return on days 7 and 14 to determine response to medication and medication dose can be increased to 5 mg and 10 mg, respectively, based on incomplete symptom response (mean change GCSI-DD < 0.5). The total dose of olanzapine will not exceed 10 mg daily during this study and subjects will continue on treatment for a total of 8 weeks.
16169828|NCT01625910|Behavioral|Behavioral counseling|Counseling of parents to improve their child's diet and physical activity
16169829|NCT01625897|Drug|MP-214|Patients who meet eligibility criteria will be administered a once daily oral fixed dose (3mg or 6mg) of MP-214 for four weeks, then flexible dose (1.5-9mg) of MP-214
16169830|NCT01625897|Drug|Risperidone|Patients who meet eligibility criteria will be administered a once daily oral fixed dose (4mg) of risperidone for two weeks, then flexible dose (2-12mg) of risperidone
16169831|NCT01625871|Drug|tablets artemether/lumefantrine|six doses of oral tablets of artemether/lumefantrine
16169832|NCT01625845|Drug|Pentoxifylline|Pentoxifylline 400 mg p.o. t.i.d. for 12 weeks
16169833|NCT01625845|Other|Placebo|Placebo pills will match the study drug for color, taste, texture, size, and smell. Participants will receive the same instructions as those randomized to pentoxifylline.
16169869|NCT01625494|Drug|Irbesartan/Amlodipine (150/10mg)|Pharmaceutical form: tablet Route of administration: oral
16169870|NCT01625494|Drug|Irbesartan/Amlodipine (300/5mg)|Pharmaceutical form: tablet Route of administration: oral
16171946|NCT01608711|Biological|AGS-1C4D4|Intravenous Infusion
16169834|NCT01625845|Behavioral|Standard Treatment|BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session.
16169835|NCT01625832|Procedure|intermittent coronary sinus occlusion|Patients undergo two 2-minute coronary balloon occlusions. Patients are randomized to CSO first or CSO second.
16169836|NCT01625819|Behavioral|Tai Chi|32 1-hour bi-weekly group sessions of Tai Chi instruction
16169837|NCT01625819|Behavioral|Resistance Band|32 1-hour bi-weekly group sessions of Resistance Band exercises
16169838|NCT01625819|Behavioral|Health Education|32 1-hour bi-weekly group sessions of health education
16169839|NCT01625806|Drug|RO4602522|Single oral dose
16169840|NCT01625806|Drug|ketoconazole|Multiple oral doses
16169841|NCT01625793|Drug|Interferon-alpha|Hepatitis C patients who are eligible to receive IFN-alpha treatment and enrolled in this study will be treated with pegylated IFN-alfa-2b or pegylated IFN-alfa-2a plus ribavirin at a dose of 800-1,400 mg/d as determined by the treating gastroenterologist. All medication administration is for purely clinical indications as dictated by treating physicians. Any and all diagnostic or treatment issues related to potential treatment with IFN-alpha will be conducted by treating clinicians. Subjects will be randomized to start their clinical (non-research) treatment following completion of baseline assessments or to delay the start of their clinical (non-research) treatment by 7 weeks.
16169842|NCT01625780|Procedure|3-layer block|"0.3 mL/kg of 0.25% bupivacaine (one injection in each layer) will be delivered by the 3-layer method using a standard 20-gauge block needle."
16169843|NCT01625780|Procedure|Single-shot block|0.3 mL/kg of 0.25% bupivacaine will be delivered by the standard, single-shot method using a 20-gauge block needle.
16169844|NCT01625767|Behavioral|AAT experiment|Smokers and nonsmokers complete AAT experiment
16169845|NCT01625754|Behavioral|Exercise|All individuals will be prescribed an exercise regimen according to their cardiac rehabilitation program
16169846|NCT01625741|Drug|Rituximab|2000 mg, IV, monthly, for 4 months (= 4 doses)
16169847|NCT01625715|Drug|Ketotifen|titrated dose: 1 mg once a day, then 1 mg twice a day then 2 mg twice a day
16169848|NCT01625702|Device|CellSearch® CTC kit|"Collect peripheral blood sample of 100 gastric cancer patients pre-chemotherapy treated with capecitabine/paclitaxel (XPa) and capecitabine/cisplatin (XP) and post two cycles of chemotherapy(response evaluation).
~Blood samples will be transferred to central lab to detect CTCs by Cellsearch kit.
~Tumor response evaluation will be performed after two cycles of chemotherapy by CT/MRI based on RECIST. Clinical data, including tumor stage, metastastic organ, chemotherapy regimen, objective response, progression free survival, overall survival, etc, will be collected according to study protocol."
16169849|NCT01625689|Biological|SIIL LAIV (live, trivalent seasonal influenza vaccine)|Dose: 0.5 mL, The viral strains in seasonal trivalent influenza vaccine (human, live attenuated) are antigenically similar to A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008 Type B, as per the WHO recommended strains for the Northern hemisphere 2011-12 influenza season
16169850|NCT01625689|Biological|Placebo|Inactive placebo will be identical to SII LAIV in appearance, ingredients, and concentrations, except it will be missing attenuated influenza virus.
16169851|NCT01625676|Other|Investigate efficacy of modified ciat schedule|2 hours of training over 15 days
16169852|NCT01625676|Other|examine the efficacy of standard treatment versus modified ciat schedule|2 hours of training over 15 days
16169853|NCT01625637|Behavioral|AAT-experiment|This AAT condition trains kids to avoid cigarettes
16169854|NCT01625637|Behavioral|AAT-placebo|This AAT condition is a no contingency continued assessment version (50% approach-cigarettes, 50% avoid cigarettes).
16169855|NCT01625624|Other|Carbohydrate Food Bar|Control Food Bar containing carbohydrate
16169856|NCT01625624|Other|Modified Carbohydrate Food Bar|Test Food Bar containing modified carbohydrate
16169857|NCT01625611|Drug|Naltrexone|Naltrexone 100 mg titrated over one week
16169858|NCT01625598|Procedure|Photography of the retina|Every subject will undergo photography of the retina in both eyes
16169859|NCT01625598|Procedure|Retinal photography|"Device
~Subjects will have photography of both eyes"
16169860|NCT01625572|Procedure|Transversus abdominis plane blockade|Bilateral one time injection of local anaesthetic in the space between the transversus abdominis muscle and obliquus internus muscle preoperatively. Follow up for three days.
16169861|NCT01625572|Procedure|Morphine-patient-controlled-analgesia-device|Morphine-patient-controlled-analgesia-device for three days: 1mg/ml, Dosage 2mg bolus injection on demand every 10 minutes possible.
16169862|NCT01625559|Biological|MA09-hRPE|MA09-hRPE: 50,000 cells
16169863|NCT01625546|Device|Whole Body Hyperthermia system|The Whole Body Hyperthermia system uses water-filtered infrared-A (wIRA) heat radiation. The rise in the body's core temperature is correspondingly rapid and well-tolerated. There are two phases of the thermal challenge, 1) Irradiation phase during which the patient lies recumbent with his/her head positioned outside the tent. The wIRA irradiators are arranged above the exposed upper part of the body; and 2) Heat retention phase during which the patient lies in the chamber with the walls of the tent positioned to retain heat.
16169864|NCT01625533|Procedure|Standard Coronary Angiography|Using standard coronary angiography (SA) for the diagnosis of coronary artery disease.
16169865|NCT01625533|Procedure|Dual-axis Rotational Coronary Angiography|Using dual-axis rotational coronary angiography (DARCA) for the diagnosis of coronary artery disease.
16169866|NCT01625520|Drug|SOM230 alone or in combination with RAD001.|SOM230 (pasireotide) 60 mg i.m. injection once every 28 days, +/- 2 days. RAD001 (everolimus) 10 mg per os daily.
16169867|NCT01625507|Behavioral|PANDA intervention|Participants will follow a menu plan and receive training in how to manage their diet in type 2 diabetes, following the recommendations of the Canadian Diabetes Association, 2008
16169868|NCT01625494|Drug|Irbesartan/Amlodipine (150/5mg)|Pharmaceutical form: tablet Route of administration: oral
16171947|NCT01608711|Biological|gemcitabine|Intravenous Infusion
16169871|NCT01625494|Drug|Irbesartan/Amlodipine (300/10mg)|Pharmaceutical form:tablet Route of administration: oral
16169872|NCT01625481|Device|Seal-V|Seal-V is applied adjunctively to cover the suture lines.
16169873|NCT01625468|Behavioral|Educational print materials and a coaching call|Intervention group participants receive three sets of mailed educational materials about making their home smoke-free and one coaching call.
16169874|NCT01625455|Drug|Aprepitant|Aprepitant will be given orally in a dose of 125mg on day 1 and 80mg daily on each subsequent day for a total of 7 days.
16169875|NCT01625455|Drug|Placebo|Placebo will be given orally for a total of 7 days.
16169876|NCT01625442|Drug|Saffron tablet|Saffron tablets 100 mg
16169877|NCT01625442|Drug|Barberry tablet|Barberry tablets 200 mg
16169878|NCT01625442|Drug|Placebo|Placebo tablets received daily for 45 days
16169879|NCT01625429|Drug|nab-paclitaxel|nab-paclitaxel 125mg/m2, day 1, 8, 15, q4w; carboplatin AUC 2, day 1, 8, 15, q4w; for HER-2 positive patients: trastuzumab loading dose 4mg/kg, then 2mg/kg, day 1, 8, 15, 22, q4w. All patients will receive up to four cycles except for unacceptable toxicity
16169880|NCT01625416|Behavioral|Stepped Care Management|All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns. The TSS will complete follow-up correspondence across the 3-6 month time period to assess mental health functioning and use of information technology that addresses medical concerns. Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-6 months.
16169881|NCT01625403|Drug|rhBNP|intravenous administration of rhBNP 0.01 µg/kg/min
16169882|NCT01625403|Drug|standard of care|standard of care for heart failure
16169883|NCT01625390|Drug|BAY86-6150|Four dose levels (6.5 µg/kg, 20 µg/kg, 50 µg/kg and 90 µg/kg) of BAY86-6150 will be studied.
16169884|NCT01625390|Drug|eptacog alfa [activated]|comparative PK/PD (pharmacokinetics/pharmacodynamics) evaluation
16169885|NCT01625390|Drug|BAY86-6150|Confirmation of recommended dose of BAY86-6150 to be evaluated further as determined in Part A.
16169886|NCT01625377|Drug|tacrolimus|Arm 1 : tacrolimus (C0 6-10 ng/ml) from D3-D5 post-transplantation to month 6 post-transplantation. Arm 2 : tacolimus (C0 6-10 ng/ml) from D3-D5 post-transplantation to 16 weeks post-transplantation at the latest.
16169887|NCT01625377|Drug|everolimus|Arm 1: no everolimus Arm 2: everolimus (C0 6-10 ng/ml) from randomization to month 6 post-transplantation
16169888|NCT01625377|Drug|Basiliximab|Basiliximab was supplied to the participating centers as marketed, i.e. in packs containing one vial of 20-mg powder, and water for injection (WFI). 20 mg at D0 and D4
16169889|NCT01625377|Drug|Mycophenolic Acid|Dose of 1440 mg/day from transplantation to month 6 post- transplantation
16169890|NCT01625377|Drug|Corticosteroids|Administration of oral corticosteroid therapy was at the discretion of the centers according to their usual practice
16169891|NCT01625364|Behavioral|SHARP program|Staying Healthy-Asthma Responsible and Prepared is an academic and counseling asthma health education program for older school-age students with asthma and members of their social networks including their family caregivers.
16169892|NCT01625364|Behavioral|Open Airways for Schools|OAS is a non-academic asthma health education program for elementary students with asthma and their parents.
16169893|NCT01625351|Drug|alemtuzumab|Patients receive alemtuzumab on days -14 through -12 (Day 0 = stem cell transplantation).
16169894|NCT01625351|Drug|fludarabine|Patients receive fludarabine phosphate on days -11 through -7. (Day 0 = stem cell transplantation.)
16169895|NCT01625351|Drug|sirolimus|"Patients receive sirolimus beginning on day -1 with taper beginning on day 90. (Day 0 = stem cell transplantation.)
~Participants treated after activation of protocol revision 2.3 on 06/05/2014 have not and will not receive sirolimus as part of their therapy."
16169896|NCT01625351|Drug|Busulfan|Patients receive busulfan on days -6 through -3. (Day 0 = stem cell transplantation.)
16169897|NCT01625351|Drug|melphalan|Patients receive melphalan on days -2 and -1. (Day 0 = stem cell transplantation.)
16169898|NCT01625351|Biological|stem cells|Patients undergo CD3 depleted haploidentical hematopoietic stem cell transplant (HSCT) on day 0. Patients also undergo CD45RA depleted HSCT infusion on day 1. (Day 0 = stem cell transplantation.)
16169899|NCT01625351|Device|CliniMACS|The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells.
16169900|NCT01625338|Drug|SOF|SOF 400 mg tablet administered orally once daily
16169901|NCT01625338|Drug|RBV|RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
16169902|NCT01625338|Drug|Peg-IFN|Peg-IFN 180 μg administered once weekly by subcutaneous injection
16169903|NCT01625299|Dietary Supplement|Gluten and dry milk|0.5 g/kg/day of gluten 0.5 g/kg/day of dry milk
16169904|NCT01625299|Dietary Supplement|Placebo|Rice flour 1.0 g/kg/day
16169905|NCT01625286|Drug|AZD5363 when combined with weekly paclitaxel.|AZD5363: oral capsule, twice daily in a weekly 2 days on-treatment, 5 days-off, schedule. Treatment to begin the day following the first dose of paclitaxel and to continue until treatment withdrawal. Paclitaxel: intravenously once a week. AZD5363 and paclitaxel will be received for 3 consecutive weeks, followed by one week off-therapy in 4-week cycles.
16169906|NCT01625286|Drug|AZD5363 when combined with weekly paclitaxel.|AZD5363: oral capsule, twice daily in a weekly 4 days on-treatment, 3 days-off, schedule. Treatment to begin the day following the first dose of paclitaxel and to continue until treatment withdrawal. Paclitaxel: intravenously once a week. AZD5363 and paclitaxel will be received for 3 consecutive weeks, followed by one week off-therapy in 4-week cycles.
16169942|NCT01625000|Drug|MP-214 3mg|Patients who meet eligibility criteria will be administered a once daily oral 3mg of MP-214 for six weeks.
16169943|NCT01625000|Drug|MP-214 6mg|Patients who meet eligibility criteria will be administered a once daily oral 6mg of MP-214 for six weeks.
16172012|NCT01608087|Drug|BI 695502|BI 695502 single i.v. infusion
16169907|NCT01625286|Drug|AZD5363when combined with weekly paclitaxel.|Either a 2/5 or 3/4 intermittent dosing schedule of AZD5363 based on the outcome of Part A. Dosage: oral formulation, twice daily. Treatment to begin the day following the first dose of paclitaxel and to continue until treatment withdrawal. Paclitaxel: intravenously once a week. AZD5363 and paclitaxel will be received for 3 consecutive weeks, followed by one week off-therapy in 4-week cycles.
16169908|NCT01625286|Drug|A placebo in combination with weekly paclitaxel.|Either a 2/5 or 3/4 intermittent dosing schedule of placebo matched to AZD5363 based on the outcome of Part A. Dosage: oral formulation, twice daily. Treatment to begin the day following the first dose of paclitaxel and to continue until treatment withdrawal. Paclitaxel: intravenously once a week. placebo and paclitaxel will be received for 3 consecutive weeks, followed by one week off-therapy in 4-week cycles.
16169909|NCT01625273|Other|Lactobacillus paracasei paracasei strain F19|Provided in an infant formula, 10^8 CFU per day from 28 days to 6 months of infant age
16169910|NCT01625260|Biological|ALT-801|Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 3, 5, 8 and 15 of each course.
16169911|NCT01625260|Drug|Gemcitabine|Intravenous infusion: 2 treatment courses and 1 maintenance course; on Day 1 and 8 of each course.
16169912|NCT01625247|Procedure|Surgical drainage|Postoperative abdominal drainage were connected to a 200-mL closed suction reservoir. The drainage was removed if there are drainage amount less than 20 mL and color was serous color.
16169913|NCT01625234|Drug|Phase I: X-396 (ensartinib)|Oral, ALK inhibitor
16169914|NCT01625234|Drug|Phase II: X-396 (ensartinib)|Expanded Cohort
16169915|NCT01625221|Device|Magnetic Anal Sphincter|The implantable single-use Magnetic Anal Sphincter (FENIX) device consists of a series of titanium beads with magnetic cores that are linked together with independent titanium wires forming an annular shape. The device is supplied sterile and is placed through an open incision.
16169916|NCT01625208|Procedure|Combined nerve block|Combined supraclavicular brachial plexus block plus ulnar or median nerve block (depending on the location of surgery)
16169917|NCT01625208|Procedure|Supraclavicular block|Standard supraclavicular brachial plexus block
16169918|NCT01625195|Dietary Supplement|omega-3 fatty acid supplementation|This study will use a randomized placebo-controlled double-blind design and the intervention period will be 6 months. Participants will be instructed to consume 4 x 1285 mg fish oil capsules/d, two capsules with each of the main daily meals. The placebo will be composed of corn/soybean oil as used in other randomized placebo-controlled trials. The daily treatment will provide 1.2 g/d of DHA and 2.4 g/d of EPA (Ocean Nutrition Canada, Dartmouth, NS). All capsules will contain citrus flavor to mask the fishy taste and odor of the LC-omega-3 oil and will be provided to the participants monthly.
16169919|NCT01625195|Dietary Supplement|corn/soybean oil placebo|This study will use a randomized placebo-controlled double-blind design and the intervention period will be 6 months. Participants will be instructed to consume 4x 1285 mg capsules/d, two capsulesat breackfast and two capsules at dinner. The placebo will be composed of corn/soybean oil as used in other randomized placebo-controlled trials.
16169920|NCT01625182|Drug|Fingolimod|Fingolimod 0.5 mg capsules
16169921|NCT01625182|Drug|Placebo Comparator|Matching placebo capsules
16169922|NCT01625169|Drug|Etravirine pharmacokinetics in breast milk and plasma|HIV+ pregnant women will receive etravirine 200mg PO BID for 14 days postpartum. PK will be done on postpartum days 5 and 14.
16169923|NCT01625156|Other|Laboratory Biomarker Analysis|Correlative studies
16169924|NCT01625156|Other|Pharmacological Study|Correlative studies
16169925|NCT01625156|Drug|Temsirolimus|Given IV
16169926|NCT01625156|Drug|Tivantinib|Given PO
16169927|NCT01625143|Other|laboratory biomarker analysis|Correlative studies
16169928|NCT01625130|Dietary Supplement|Broccoli sprout homogenate|Commercially available Broccosprouts® (Brassica Protection Products LLC) will be homogenized with water using a ratio of 1:1.2 in a clean blender. The homogenate will then be frozen in aliquots at -20 degrees C.
16169929|NCT01625130|Dietary Supplement|alfalfa sprout homogenate|200 grams of alfalfa sprouts will be homogenized with water using a ratio of 1:1.2 in a clean blender. The homogenate will then be frozen in aliquots at -20 degrees C.
16169930|NCT01625117|Behavioral|A variant of Narrative Exposure Therapy|During the proposed therapy, the client constructs a chronological narrative of his or her whole life which includes all traumatic experiences and perpetrated violent acts. All emotions, cognitions, sensory information, and physiological reactions are activated and linked to the autobiographical context.In five sessions the therapist and the client try to go through all important traumatic experiences and perpetrated violent acts. The sixth session is a group session with four to five clients. The group session is oriented on Interpersonal Psychotherapy and focuses on the role change from soldier to civilian.
16169931|NCT01625104|Other|Non Intervention|Business as usual
16169932|NCT01625104|Other|Agressive Intervention Process Improvement Strategies|
16169933|NCT01625091|Drug|Naltrexone|The study involves taking the drug naltrexone for up to 4 months. This will be given in a single pill each day for 4 months.
16169934|NCT01625091|Drug|Placebo|Placebo is an inert pill that looks the same as naltrexone. The placebo will be taken once each day for up to 4 months.
16169935|NCT01625078|Device|Placement and use of Baska mask|Use of Baska mask as a supraglottic airway during general anesthesia
16169936|NCT01625052|Device|Placement and use of Baska mask|use of Baska mask as component of standard general anaesthetic
16169937|NCT01625039|Behavioral|Employee wellness programme|The experimental group was subjected to a wellness programme based on the principles of cognitive behaviour therapy (CBT) as well as weekly supervised exercise classes over six weeks.
16169938|NCT01625039|Behavioral|Comparator (Once off educational session and educational materials)|Once off educational session and educational materials
16169939|NCT01625026|Drug|Obeticholic acid|Obeticholic acid 25 mg/day in three weeks
16169940|NCT01625026|Drug|Placebo|Placebo to obeticholic acid
16169941|NCT01625013|Device|Synvisc-One (G-F 20)|Synvisc G-F 20 will be injected in the symptomatic knee using a standard supine lateral approach using a 20-gauge needle. Patients will be treated at baseline and followed out to three years. Patients may return for retreatment as early as 4 months post their prior injection if they meet the retreatment criteria pain levels for Worst Knee Pain. If the subjects need another injection, the follow-up cycle will restart at Visit 1 and the subject will be seen every 6 months and followed-up for 3 years.
16169944|NCT01625000|Drug|MP-214 9mg|Patients who meet eligibility criteria will be administered a once daily oral 9mg of MP-214 for six weeks.
16169945|NCT01625000|Drug|Risperidone 4mg|Patients who meet eligibility criteria will be administered a once daily oral 4mg of risperidone for six weeks.
16169946|NCT01625000|Drug|Placebo|Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks.
16169947|NCT01624987|Behavioral|NET for Forensic Offender Rehabilitation (FORNET): a variant of Narrative Exposure Therapy|During the proposed therapy, the client constructs a chronological narrative of his or her whole life which includes all traumatic experiences and perpetrated violent acts. All emotions, cognitions, sensory information, and physiological reactions are activated and linked to the autobiographical context.In five sessions the trained therapist and the client try to go through all important traumatic experiences and perpetrated violent acts. The sixth session is a group session with four to five clients. The group session is oriented on Interpersonal Psychotherapy and focuses on the role change from soldier to civilian.
16169948|NCT01624987|Other|Control group|The control group receives no intervention.
16169949|NCT01624974|Drug|MK-1029|MK-1029 150 mg tablets taken QD
16169950|NCT01624974|Drug|Placebo|Placebo tablets (matching the MK-1029 150 mg tablets) QD
16169951|NCT01624974|Drug|Montelukast (ML)|ML 10 mg tablets QD
16169952|NCT01624961|Biological|PfSPZ Challenge|PfSPZ Challenge are aseptic, cryopreserved P. falciparum sporozoites.
16169953|NCT01624948|Drug|Everolimus|Everolimus will be administered orally at a starting dose of 0.75 mg PO b.i.d. (1.5 mg/day). Everolimus whole blood trough levels will be monitored at pre-specified time points to achieve a range of 3-8 ng/mL. Group 1 patients will continue on prednisone and tacrolimus with a target whole blood trough level of 3-6 ng/mL.
16169954|NCT01624948|Drug|Mycophenolic acid dose reduction|Group 2 patients will undergo a 50% reduction of the mycophenolic acid (MPA) dose, and continue with tacrolimus (target trough level of 6-10 ng/mL), and prednisone.
16169955|NCT01624935|Behavioral|interpersonal psychotherapy|interpersonal psychotherapy
16169956|NCT01624857|Drug|Rosuvastatin|Rosuvastatin for at least 5 days before the CABG surgery, then continue to take for a month after the surgery.
16169957|NCT01624857|Drug|Placebo|Placebo for at least 5 days before the CABG surgery, then continue to take for a month after the surgery.
16169958|NCT01624844|Other|Geometrical calculation of dural sac volume|Geometrical calculation of the lumbar dural sac volume following multilevel measurements by ultrasound imaging before spinal anesthesia
16169959|NCT01624818|Behavioral|Cardiac habilitation program|physical activity three weeks
16169960|NCT01624805|Biological|Anti-Thymocyte Globulin|Given IV
16169961|NCT01624805|Drug|Cyclosporine|Given PO
16169962|NCT01624805|Biological|Filgrastim|Given SC
16169963|NCT01624805|Drug|Methylprednisolone|Given IV or PO
16169964|NCT01624805|Biological|Pegfilgrastim|Given SC
16169965|NCT01624792|Dietary Supplement|Olive oil|Dose: 7.0 g/day (= 7 capsules/day).
16169966|NCT01624792|Dietary Supplement|Fish oil|Dose: 7.0 g/day (= 7 capsules/day = 3.5g EPA+DHA/day).
16169967|NCT01624792|Dietary Supplement|Fish oil and placebo|Dose: 7.0 g/day (= 4 capsules/day fish oil = 2.0g EPA+DHA/day and 3 capsules/day olive oil).
16169968|NCT01624779|Drug|autologous adipose tissue derived mesenchymal stem cells|autologous adipose tissue derived mesenchymal stem cells 9x107cells / 3mL Day 1 and Month 1&2
16169969|NCT01624766|Biological|Anakinra|Given SC
16169970|NCT01624766|Biological|Denosumab|Given SC
16169971|NCT01624766|Drug|Everolimus|Given PO
16169972|NCT01624753|Device|confocal microscopy|During bronchoscopy, one side of the bronchial tree will be examined (either right or left) and targeted based on pre-procedure HRCT/CT scan findings. A 1.4mm diameter Alveoflex Confocal MiniprobeTM (MaunaKea Technologies, France) will be deployed down the working channel of the standard bronchoscope and advanced distally into the alveoli. Images are acquired by gentle contact providing real-time imaging and microstructural detail of the alveolus which will be continuously recorded during the procedure and stored for further morphometric and cellular analyses. Up to 10 bronchoalveolar areas will be observed and the location of the corresponding lung segment will be registered according to the international bronchial nomenclature.
16169973|NCT01624740|Device|Low Rate Stimulation|Stimulation was given at a rate of 2 Hz.
16169974|NCT01624740|Device|High Rate Stimulation|Stimulation was given at a rate of 1200 Hz.
16169975|NCT01624727|Dietary Supplement|Omega 3 acid ethyl esters|Lovaza 3.6 g daily
16169976|NCT01624714|Drug|Alemtuzumab|alemtuzumab 12 mg IV x 5 daily doses at baseline, alemtuzumab 12 mg IV x 3 daily doses at month 12
16169977|NCT01624714|Drug|Alemtuzumab immunotherapy|Alemtuzumab 60 mg over 5 days for first annual cycle, then 36 mg over 3 days for subsequent annual cycle, and as needed cycles in subsequent years.
16169978|NCT01624701|Other|Ex vivo expanded cord blood cells|Cord blood cells will be expanded ex vivo using a combination of stem cell factor (SCF), thrombopoietin (TPO), Flt3 ligand and IGFBP2 with mesenchymal stromal cell (MSC) co-culture.
16169979|NCT01624688|Procedure|Tattoo Removal|Tattoo removal with q-switched laser treatment, repeated q-switched laser treatment, repeated q-switched laser treatment with fractional ablative laser treatment, and repeated q-switched laser treatment with fractional ablative laser treatment and then topical urea
16169980|NCT01624675|Drug|Risperidone|Subjects weighing less than 20 kilogram (kg) received risperidone 0.25 milligram per day (mg/day) up to Day 4. On Day 4, dose was titrated in increments of 0.25 mg/day (up to a daily dose of 1.0 mg) at the regular study visit thereafter till Week 8. Subjects weighing greater than or equal to (>=) 20 kg received risperidone 0.5 mg/day up to Day 4. On Day 4, dose was titrated in increments of 0.5 mg per day (up to a daily dose of 2.5 mg) at the regular visit thereafter till Week 8. The maximum daily dose for subjects weighing >= 45 kg was 3.0 mg. For subjects weighing >=45 kg, the maximum daily dose was 3.0 mg.
16169981|NCT01624675|Drug|Placebo|Subjects will receive placebo matching with risperidone orally up to 8 weeks.
16169982|NCT01624662|Drug|Fluticasone propionate|Delivered via Optinose Exhalation Delivery System
16169983|NCT01624649|Drug|Methylphenidate hydrochloride|Form = tablet, route = oral, administered as a flexible dosage
16169984|NCT01624649|Drug|Atomoxetine|Form = tablet, route = oral;
16169985|NCT01624636|Drug|Placebo|
16169986|NCT01624636|Drug|LFG316|
16169987|NCT01624636|Drug|LFG316|
16169988|NCT01624610|Other|Dietary intervention|After a 14 day screening period, subjects will be randomized to 1 of 2 diets to treat their IBS symptoms. They will receive dietary instruction and are expected to remain on this diet for 4 weeks.
16169989|NCT01624597|Behavioral|In-vehicle video feedback|An in-vehicle video system will record driving errors and safety behaviors. A light on the system will blink to let the participant know that a driving error has been recorded. Parents will receive a weekly report card.
16169990|NCT01624597|Behavioral|Parent communication|Parents will receive instruction in teaching and effective communication about driving skills and driving safety. The intervention includes driving goals for teen drivers and parent communication strategies.
16169991|NCT01624584|Behavioral|Experimental treatment|six sessions of child anxiety treatment
16169992|NCT01624584|Behavioral|Traditional Treatment|six sessions of treatment consistent with current practice
16169993|NCT01624571|Drug|LD02GIFRO|comparison of different dosages of drug
16169994|NCT01624558|Device|In-line Carbon filter (Vapor-Clean)|Carbon filter placed in anesthesia breathing circuit.
16169995|NCT01624545|Other|cranial CT scan|Patients in this study arm will receive a cranial CT scan on day 2 and day 30 after evacuation of a chronic subdural hematoma in addition to neurological evaluation on day 2 and 30.
16169996|NCT01624532|Biological|GC1109 or Placebo of GC1109|"Step1: Administer 0.3mL or 0.5mL or 0.1mL or placebo of GC1109 into the deltoid muscle three times every four weeks.
~Step2: Administer 1.0mL of GC1109 or placebo of GC1109 into the deltoid muscle three times every four weeks, and once after 24 weeks."
16169997|NCT01624519|Procedure|Blood Lactate Analysis|When an arterial lactate is deemed to be necessary as part of ICU management, a central venous and peripheral venous sample will also obtained within 5 minutes. All of the samples will be analyzed using the same analyzer as quickly as possible.
16169998|NCT01624493|Drug|Carboplatin|Carboplatin AUC4 on day 1 of 21-day cycle, for a maximum of 6 cycles.
16169999|NCT01624493|Drug|Gemcitabine|Gemcitabine escalations 800 and 1000 mg/m2 (as determined in phase I) on days 1 and 8 of a 21 day cycle, for a maximum of 6 cycles.
16170000|NCT01624493|Drug|Carboplatin|Carboplatin AUC 4 on day 1 of a 21 day cycle, for a maximum of 6 cycles.
16170001|NCT01624493|Drug|Gemcitabine|Gemcitabine 800 or 1000 mg/m2 (as determined in phase I) on days 1 and day 8 of 21-day cycle, for a maximum of 6 cycles.
16170002|NCT01624493|Drug|BNC105P|BNC105P as determined in phase I, on days 2 and 9 of a 21 day cycle for a maximum of 6 cycles, followed by single agent maintenance BNC105P 16 mg/m2 for a maximum of 6 additional cycles.
16170003|NCT01624480|Drug|Armodafinil|The armodafinil tablets to be used in this study contain 50 mg of armodafinil and the following inactive ingredients: lactose monohydrate, starch, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, and povidone.
16170004|NCT01624467|Biological|Necitumumab|800 mg necitumumab, administered once per week IV
16170005|NCT01624454|Other|Laxabon|4 l PEG solution split dose cleansing
16170006|NCT01624454|Other|CitraFleet|Small volume osmotic bowelcleansing
16170007|NCT01624441|Drug|Dinaciclib|Given IV
16170008|NCT01624441|Drug|Epirubicin Hydrochloride|Given IV
16170009|NCT01624441|Other|Laboratory Biomarker Analysis|Correlative studies
16170010|NCT01624428|Drug|Varenicline|1 mg bid varenicline titrated over a 2 week period
16170011|NCT01624428|Drug|Placebo|1 mg bid placebo titrated over a 2 week period
16170012|NCT01624402|Behavioral|Education on Stroke and Depression (ESD)|"Each session begins by assessing the subject's and his/her family's level of information in a given area and by identifying misconceptions, thus guiding the selection of educational material.
~Comprehending illness-related information is a process contaminated by pessimism, denial, misconceptions, and stigma. The role of the ESD therapist is to impart valuable information, despite these complexities.
~Conveying information is a process. The ESD therapist needs to be aware of where the subject and family are in each session and offer information for which they have readiness to accept.
~ESD therapists do not engage in additional interventions (e.g., cognitive behavioral therapy, interpersonal therapy, problem solving therapy)."
16170013|NCT01624402|Behavioral|Ecosystem Focused Therapy (EFT)|"EFT offers an action-oriented, new perspective about the subject's recovery;
~It provides an adherence enhancement structure;
~It offers a problem solving structure to the subject focusing on problems, valued by the subject, and pertinent to daily function;
~It helps the family re-engineer its goals, involvement, and plans to accommodate the patient's disability;
~It coordinates care with specialized therapists with the goal to increase patient participation in rehabilitation and social activities."
16170014|NCT01624389|Drug|F18-AV45|"This study will recruit a total of 200 evaluable subjects (50 cognitively normal volunteers, 100 MCI, and 50 AD, respectively) Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping.
~Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events."
16170015|NCT01624376|Drug|DLX105|10mg DLX105/injection injected into the fistula over a treatment period of 4 weeks.
16170016|NCT01624376|Drug|Placebo|Placebo injections are administered over the treatment period of 4 weeks.
16170017|NCT01624350|Device|Permacol collagen paste|Collagen paste intended to reinforce soft tissue where filling is required such as to repair fistulas, including anal and rectal fistulas.
16170018|NCT01624337|Drug|DHA-piperaquine|"Drug: Dihydroartemisinin piperaquine
~40/320 mg tablets, 9 tablets total Arms: 2 day treatment course (4.5 tablets per day)"
16170019|NCT01624337|Drug|placebo|
16170020|NCT01624311|Other|Therapeutic Hypothermia|After obtaining written consent, patients are cooled to 33.5°C (+/- 1°C ) for 72 hours and and then rewarmed by 0.5°C per every 3 hours over 18 hours.
16170021|NCT01624311|Other|Standard of Care Therapy|Patients with hyperammonemia and encephalopathy requiring renal replacement therapy due to a urea cycle disorder or organic acidemia that were treated at Children's National Medical Center over the past 10 years.
16170022|NCT01624298|Behavioral|Trauma Focused Cognitive Behavioral Therapy|TF-CBT (www.musc.edu/tfcbt) is a therapy that helps children/youth ages 5-18 years and their families who have been affected by traumatic events and/or traumatic grief. Components include psychoeducation, relaxation, affective modulation, cognitive processing, Trauma Narrative (gradual exposure), In-vivo exposure, Con-joint session, and Enhancing safety skills. Youth and caregivers are seen once a week for approximately 12 weeks.
16170023|NCT01624285|Drug|sorafenib tosylate|Given PO
16170026|NCT01624272|Device|Threshold® Inspiratory Muscle Trainer (Respironics® Health Scan Inc. Cedar Grove, NJ, USA).|Interval-based program consisting of seven cycles of 2-minutes work and 1-minute rest. The sessions took place 5 times per week over a six-week period for a total of 30 sessions. All participants were familiarized with the breathing exercises over a two-day familiarization period at the beginning of the protocol.
16170027|NCT01624272|Other|Yoga Pranayama breathing exercises|Interval-based program. The sessions took place 5 times per week over a six-week period for a total of 30 sessions. All participants were familiarized with the breathing exercises over a two-day familiarization period at the beginning of the protocol.
16170028|NCT01624259|Drug|LY2189265|Administered SC
16170029|NCT01624259|Drug|Liraglutide|Administered SC
16170030|NCT01624259|Drug|Metformin|
16170031|NCT01624246|Drug|Ceftaroline fosamil/Avibactam (CXL)|IV infusion of CXL (combination of ceftaroline fosamil [600 mg] plus avibactam [600 mg]) infused over 60 (± 5) minutes.
16170032|NCT01624233|Drug|80 mg ixekizumab|Administered SC
16170033|NCT01624220|Radiation|Spinal SBRT (Standard Dose)|Group 1 and 2: Standard doses of radiation therapy to the normal esophagus while treating the tumor. Up to 2 groups of 10 participants enrolled.
16170034|NCT01624220|Radiation|Spinal SBRT (Higher Dose)|Group 3 and 4: Higher dose of radiation to esophagus than group before it, if no intolerable side effects were seen. 2 groups of 10 participants enrolled in the second part of study. Only participants who will receive a single spinal SBRT treatment are eligible for second part of study.
16170035|NCT01624220|Procedure|Gold Seed Implantation|4 gold seeds implanted into bones of spine: 2 gold seeds above and 2 gold seeds below the area of tumor to be treated.
16170036|NCT01624220|Behavioral|Questionnaires|Completion of questionnaire before radiation treatment starts, and 1 time a week for the next 4 weeks. It should take about 10 minutes to complete.
16170037|NCT01624207|Drug|generic formulation of atorvastatin (Atorva®)|Treatment with generic formulation of atorvastatin (Atorva®) once daily, for 8 weeks
16170038|NCT01624207|Drug|branded formulation of atorvastatin (Lipitor®)|Treatment with branded formulation of atorvastatin (Lipitor®)once daily, for 8 weeks
16170039|NCT01624194|Drug|Oxytocin nasal spray|24IU BID (3 x 0.1 mL [4IU] sprays per nostril twice daily for 4-weeks.
16170040|NCT01624194|Drug|Placebo|3 x 0.1 mL sprays per nostril twice daily for 4-weeks.
16170041|NCT01624168|Behavioral|Anxiety Management Education|written materials on management of anxiety for self-study
16170042|NCT01624168|Behavioral|10 week tai chi intervention|10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week
16170043|NCT01624168|Behavioral|Enhanced tai chi instruction|10 weeks of instruction in Evidence Based Tai Chi meeting 2 times per week plus DVD for home practice
16170044|NCT01624155|Behavioral|Education|EMR referral to teratogen and contraception counseling
16170045|NCT01624142|Biological|Evolocumab|Evolocumab was administered by subcutaneous injection either once a month (QM) or once every two weeks (Q2W).
16170046|NCT01624129|Drug|Fluticasone|Guideline-based treatment with fluticasone 0,5 ml (1-0-1), step-up or step-down after 3 months based on the histopathological findings
16170047|NCT01624116|Drug|Acarbose|Tab.Acarbose 50mg BD for one day in addition to existing medication to 10% of patients in each treatment arm.
16170048|NCT01624116|Other|Diet and lifestyle|Patients would follow a 1200 KCal Ramadan diet plan, and exercise for 30 minutes per day
16170049|NCT01624116|Drug|Metformin|Patients on metformin monotherapy prior to Ramadan will continue on it, in the same dose
16170050|NCT01624116|Drug|Metformin/ Glimepride|Metformin 500mg and Glimepride 1mg in a combination tablet. Dosage frequency BD
16170051|NCT01624116|Drug|Metformin/Sitagliptin|Metformin 500 and sitagliptin 50mg in a combination tablet,dosage frequency BD.
16170052|NCT01624103|Procedure|Upper limb surgery|Elderly patients undergoing upper limb surgery received 20 ml of LA volume (50:50 mixture of levobupivacaine 0.5% and lidocaine 2%) for US-SCB. An independent observer unaware of the LA volume recorded maximal pain intensity resulting from block placements, questioned the patients about possible unpleasant events linked to the performance of US-SCB and assessed patient's satisfaction.
16170053|NCT01624103|Procedure|Upper limb surgery|Elderly patients undergoing upper limb surgery received 32 ml of LA volume (50:50 mixture of levobupivacaine 0.5% and lidocaine 2%) for US-SCB. An independent observer unaware of the LA volume recorded maximal pain intensity resulting from block placements, questioned the patients about possible unpleasant events linked to the performance of US-SCB and assessed patient's satisfaction.
16170054|NCT01624090|Drug|Mithramycin|30 mcg/kg intravenous (IV) over 6 hours once daily for 7 days, to be repeated every 21 days (one cycle) until disease progression or unacceptable toxicity
16170055|NCT01624077|Biological|Regulatory T cells|Tregs will inject after liver transplantation
16170056|NCT01624064|Drug|Enalapril|2.5-20 mg/day
16170057|NCT01624064|Drug|Calcium Supplement|Calcium 2.5-20 mg/day
16170058|NCT01624051|Other|Standard dosing method arm: Cisplatin (chemotherapy) dosing based on body surface area|Cisplatin dosing calculated at the rate of 75 mg/m2
16170059|NCT01624051|Other|Experimental dosing method arm: Cisplatin (chemotherapy) dosing based on individual lean body mass|Cisplatin dosing calculated at the rate of 3.10 mg/kg lean body mass
16170060|NCT01624038|Drug|Hydroxyurea ,Epiao|"Hydroxyurea (Myers-Squibb, USA) was administered in dosages ranging from 15 up to 35 mg/kg/day orally over 7 days/week.
~Erythropiotien therapy (rHuEPO - Epiao) from 250 to 500 IU/kg rHuEPO subcutaneously three times a week."
16170061|NCT01624038|Drug|hydroxyurea, blood transfusion|Hydroxyurea was administered in dosages ranging from 15 up to 35 mg/kg/day orally over 7 days/week. Hydroxyurea toxicity was defined as a white cell count of less than 2500/μL or a platelet count of less than 100,000/μL, in which case the drug was discontinued.
16170062|NCT01624025|Other|Docetaxel 60 mg/m2, epirubicin 60 mg/m2, q3wks|Both the patients with HER2 (+) and HER2 (-) patients will be treated with the same regimen.
16170063|NCT01624012|Device|NIV NAVA|Non invasive ventilation with neurally adjusted ventilatory assist
16170064|NCT01624012|Device|Nasal continuous positive airway pressure|Noninvasive respiratory support with continuous positive airway pressure
16170098|NCT01623648|Other|Arm 2 No Whey Breakfast|The patients will be assigned to eat 42 g protein from other sources in the breakfast (660 kcal), lunch (560 kcal) and dinner (280 kcal)
16172013|NCT01608087|Drug|bevacizumab|bevacizumab single i.v. infusion
16170065|NCT01623986|Device|Mespere Venus 1000 System|An adhesive patch (connected to the Mespere Venus 1000 System) is placed on the neck of the subject, to determine if the CVP values displayed by the device correlates with right atrial pressure values obtained by echocardiography(standard clinical practice)
16170066|NCT01623986|Device|Echocardiography machine|Use of ultrasound to estimate right atrial pressure from analyzing inferior vena cava (IVC).
16170067|NCT01623973|Other|specific training of paretic upper limb|nineteen individuals with chronic stroke was randomly assigned, after the first evaluation, into two groups: group without restriction (G1), subject only to the specific training of paretic UL, and restricted group (G2), which underwent specific training of paretic UL and use of the restriction of non paretic UL. The volunteers were evaluated before the beginning of the interventions, and the next day after completion of the 12 therapy sessions through the Fugl-Meyer Assessment
16170068|NCT01623947|Dietary Supplement|Placebo Beverage|1400 ml flavored, colored, artificially sweetened, non-caloric beverage divided into 6 servings provided prior to and during the 2.5 hr interval ride.
16170069|NCT01623947|Dietary Supplement|2.8 g Sustamine Beverage|1400 ml flavored, colored, artificially sweetened, beverage containing 2.8 g Sustamine divided into 6 servings provided prior to and during the 2.5 hr interval ride.
16170070|NCT01623947|Dietary Supplement|19.6 g Sustamine Beverage|1400 ml flavored, colored, artificially sweetened, beverage containing 19.6 g Sustamine divided into 6 servings provided prior to and during the 2.5 hr interval ride.
16170071|NCT01623921|Drug|standard care treatment|Group 1: control :(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal)
16170072|NCT01623921|Drug|Celecoxib|Celecoxib 200 mg × 2/d+:(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal)
16170073|NCT01623921|Drug|Rosuvastatin|Rosuvastatin 40mg × 1/d+:(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal)
16170074|NCT01623921|Drug|Combined therapy|Combined therapy with Celecoxib 200 mg× 2/d + Rosuvastatin 40× 1/d +:(standard care treatment for individual lung contusion inluding analgesia with paracetamol/dypiron/ tramal)
16170075|NCT01623908|Drug|Zoledronate|4mg, IV (in the vein) every 6 months. Number of Cycles: up to the researcher or until unacceptable toxicity develops.
16170076|NCT01623869|Other|Laboratory Biomarker Analysis|Correlative studies
16170077|NCT01623869|Biological|Trebananib|Given IV
16170078|NCT01623856|Other|laboratory biomarker analysis|Correlative studies
16170079|NCT01623843|Procedure|Arthroscopic Lavage|Lavage: inflammation debris caused from continual friction in the hip is washed out.
16170080|NCT01623843|Procedure|Arthroscopic Osteochondroplasty|"Osteochondroplasty: reshaping the hip ball and socket (osteoplasty or rim trimming)."
16170081|NCT01623830|Behavioral|Virtual Reality Exposure Therapy|Treatment will consist of 8 weekly sessions. Session 1: information gathering, treatment procedures and rationale. Session 2: Cognitive restructuring. Session 3: Breathing retraining and thought stopping. Session 4: Review cognitive restructuring and hyperventilation exposure. Sessions 5-8 Fear of flying exposure in the Virtual environment.
16170082|NCT01623817|Drug|Vancomycin HCL|"Loading dose of 30mg/kg via central or peripheral intravenous infusion during 2 or 3 hours.
~Maintenance dose of vancomycin is 15mg/kg twice a day or 1g twice a day."
16170083|NCT01623804|Device|low intensity, pulsed ultrasound|1.5MHz, spatial average-temporal average intensity = 0.03W/cm2, pulsed (burst frequency 1kHz, burst duration 200µm, duty cycle 20%); self-administered to the medial side of the knee joint while sitting down for 20 minutes every day for 3 months.
16170084|NCT01623804|Device|sham ultrasound|no ultrasonic energy emitted; self-administered to the medial side of the knee joint while sitting down for 20 minutes every day for 3 months
16170085|NCT01623778|Drug|Interferon Alfa-2a add on ADV|Interferon add on ADV for 48 weeks
16170086|NCT01623752|Drug|Etanercept|The patients will be treated in accordance with the requirements of the labelling of Enbrel® in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
16170087|NCT01623752|Drug|Etanercept|The patients will be treated in accordance with the requirements of the labelling of Enbrel® in Germany. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
16170088|NCT01623739|Procedure|Placement of a dental implant|Type 1 implant placement Type 2 implant placement
16170089|NCT01623726|Procedure|Transcranial Direct Current Stimulation (tDCS)|"Transcranial Direct Current Stimulation. Daily sessions with a total of 10 days intervention. Each intervention will take place with a 2mA intensity during 20 minutes. The current will be delivered by Chattanooga Iontophoresis Dual Channel Delivery Device, that stands for a 2-channels tDCS device in which previous dosage can be set as default to maintain frequently used treatment parameters. Main features include (a) Beeping alerts if electrode fault for open current or high impedance, low battery, treatment completion or power left on; (b)automatic 30 second current ramp up and down during power on/off keeps patient comfortable; (c) Current can be set in 0.1 mA increments between 0.5 mA and 4 mA."
16170090|NCT01623713|Drug|iloperidone|Iloperidone is being development as a treatment of schizophrenia. This trial will verify the safety and efficacy of iloperidone in patients with schizophrenia.
16170091|NCT01623713|Drug|Risperidone|Risperidone is used for the treatment of schizophrenia.Risperidone is unique among most other atypicals in that it has high affinity for the D2 receptor whereas most other atypicals have 'loose binding' of the D2 receptor. It has actions at several 5-HT (serotonin) receptor subtypes.
16170092|NCT01623687|Device|Component for acetabulum (Regenerex RingLoc cup)|A fibrous metal uncemented Regenerex RingLoc cup (Biomet, Warsaw, Il, USA)
16170093|NCT01623687|Device|Components for the acetabulum (Lubinus cross linked cup)|cemented Lubinus cross linked cup (Waldemar Link, Hamburg, Germany).
16170094|NCT01623687|Device|Arthroplasty components are for the femur (Cemented Lubinus SP II stem)|Cemented Lubinus SP II stem (Waldemar Link, Hamburg, Germany) with a ceramic 32 mm head.
16170095|NCT01623687|Device|Arthroplasty components are for the femur (Corail stem)|Uncemented HA-coated Corail stem with a ceramic 32 mm head (DePuy, Johnsson & Johnsson, USA).
16170096|NCT01623661|Other|hypertonic saline|hypertonic saline 3.0 % (7 ml/kg)
16170097|NCT01623648|Other|Arm 1 Whey Breakfast|The patients will be assigned to eat 42 g protein namely from Whey protein in the breakfast (660 kcal), lunch (560 kcal) and dinner (280 kcal)
16170099|NCT01623648|Other|Arm 3 Low Protein Breakfast|The patients will be assigned to eat 22 g protein from other sources in the breakfast (660 kcal), lunch (560 kcal) and dinner (280 kcal)
16170100|NCT01623635|Drug|Ropivacaine|"ADMINISTRATION OF STUDY DRUG All surgical port sites will be injected with 2 ml/each study drug prior to trocar insertion
~Immediately following insufflation the Optispray surgical spray device will be inserted into the abdomen and directed towards the diaphragms, dome of inflated abdomen, bowel peritoneum and surgical dissection site and the study drug will be delivered as an atomized spray in the following volumes:
~each subdiaphragmatic area 3.5 ml + 3.5ml
~surgical dissection site 3 ml
~diffusely across the peritoneal surface (dome of the abdomen and surface of the visible bowel) 7 ml. At the end of the case the remaining medication with be atomized again onto the same areas, using the same volumes.
~At the end of the case - this process will be repeated with the remaining drug (no repeat port site injections)."
16170101|NCT01623635|Drug|placebo (normal saline)|"ADMINSTRATION OF PLACEBO All surgical port sites will be injected with 2 ml/each placebo prior to trocar insertion
~Immediately following insufflation the Optispray surgical spray device will be inserted into the abdomen and directed towards the diaphragms, dome of inflated abdomen, bowel peritoneum and surgical dissection site and the placebo will be delivered as an atomized spray in the following volumes:
~each subdiaphragmatic area 3.5 ml + 3.5ml
~surgical dissection site 3 ml
~diffusely across the peritoneal surface (dome of the abdomen and surface of the visible bowel) 7 ml. At the end of the case the remaining placebo with be atomized again onto the same areas, using the same volumes.
~At the end of the case - this process will be repeated with the remaining placebo (no repeat port site injections)."
16170102|NCT01623622|Drug|HC-58|once or more / week
16170103|NCT01623622|Drug|Placebo|once or more / week
16170104|NCT01623609|Drug|Naloxegol|Naloxol IR tablet 25 mg (naloxegol oxalate) commercial formulation
16170105|NCT01623609|Drug|Naloxegol|Naloxegol film-coated Phase III formulation 25 mg film-coated IR tablet
16170106|NCT01623596|Drug|Fingolimod|
16170107|NCT01623596|Drug|Disease Modifying therapy|
16170108|NCT01623583|Other|Enhanced Needle Phobia Intervention|"The enhanced intervention will include the standard intervention, with two enhancements:
~The video will include a segment with a patient using and discussing the analgesic effects of the Synera patch
~Before the intervention, a nurse will explain how Synera works and demonstrate its efficacy by having the patient apply it to the non-dominant forearm and leave it in place for 30 minutes, during the intervention. The patient will then be given the opportunity to gently poke 3 times an area of the forearm at least 3 inches from where the patch was applied, and then poke 3 times the center of the area where the patch was applied. The patient may repeat this process up to 3 times. The patient will be asked if he or she can feel the difference in sensitivity."
16170109|NCT01623583|Other|Standard Needle Phobia Intervention|"The standard intervention will include the following components:
~Educational material and discussion with the social worker about the benefits of AVF/AVG over catheter.
~Basic training on relaxation breathing
~Brief video of a patient overcoming needle phobia
~Exposure to a cannulation needle while practicing relaxation breathing, ending in the patients physically holding the needle"
16170110|NCT01623570|Drug|Pergoveris: 150IU r-hFSH + 75IU r-hLH|Fixed formulation of two recombinant gonadotropins
16170111|NCT01623570|Drug|Menopur: HMG-HP (150 IU)|Human Menopausal Gonadotropin is an urinary estract from menopausal women containing 150IU of FSH and 150 IU of LH-like activity (HCG)
16170112|NCT01623557|Biological|ChAd63-MVA CS|1 dose of ChAd63 CS 5 x 10^10 vp intramuscularly and 1 dose MVA CS 2 x 10^8 pfu intramuscularly 8 weeks later.
16170113|NCT01623557|Biological|ChAd63-MVA ME-TRAP|1 dose of ChAd63 ME-TRAP 5 x 10^10 vp intramuscularly and 1 dose MVA ME-TRAP 2 x 10^8 pfu intramuscularly 8 weeks later.
16170114|NCT01623557|Other|Controlled Human Malaria Infection Administered by Mosquito Bite|Approximately 3 weeks post MVA dosing
16170115|NCT01623531|Drug|Fibrinogen|Intravenous concentrated fibrinogen will be infused according to a hemostatic algorithm based on ROTEM (FIBTEM)
16170116|NCT01623518|Biological|ChAdOx1-NP+M1|"Dose escalation in a 3+3 study plan;
~5 x10^8 vp, 5 x10^9 vp, 2.5 x10^10 vp, 5 x10^10 vp"
16170117|NCT01623505|Drug|Champix|"Participants receiving this treatment will start the medication on the day of the baseline assessment and set a target quit date within the 8 to 14 day period after baseline. Participants in this group will receive a 12-week supply of varenicline. Treatment will begin 2 weeks before the target quit date and continue for 10 weeks after the target quit date. Participants will be prescribed 0.5 mg once daily for 3 days, 0.5 mg twice daily for 4 days, and 1 mg twice daily for 11 weeks. Participants will be given the option of extending their treatment to a maximum of up to 24 weeks of varenicline.
~All participants will receive six 15-minute counselling sessions from a nurse-counsellor specializing in smoking cessation."
16170118|NCT01623505|Drug|Transdermal Nicoderm patch combined with gum or inhaler|"Participants receiving this treatment will set a quit date within 2 weeks after baseline assessment and apply the patch on that day. This group will follow the same regimen as the standard patch treatment, but is not limited to a fixed dosing strategy. Participants will be advised on the titration of patch (increase or decrease in dosage) to ensure elimination of withdrawal symptoms (maximum dosage of 35mg/day, maximum treatment of up to 22 weeks). Participants will be provided with either gum or inhaler to manage cravings.
~All participants will receive six 15-minute counselling sessions from a nurse-counsellor specializing in smoking cessation.
~*Off-label dosage approved by Health Canada via No Objection letter."
16170119|NCT01623505|Drug|Transdermal Nicoderm patch|"Participants receiving this treatment group (standard treatment)will set a target quit date within the 2 weeks after baseline assessment and start to apply the patch on that day. This treatment will consist of a 10-week supply of nicotine patches. The initial dosage will be determined from the average number of cigarettes smoked each day as per the manufacturer's recommendation. Participants smoking ≥ 20 cigarettes per day will be prescribed 21 mg/24 hours for 6 weeks, 14 mg/24 hours for 2 weeks, and 7 mg/24 hours for 2 weeks. Participants smoking 11 - 20 cigarettes per day will be prescribed 14 mg/24 hours for 6 weeks, and 7 mg/24 hours for 4 weeks.
~All participants will receive six 15-minute counselling sessions from a nurse-counsellor specializing in smoking cessation."
16170120|NCT01623492|Other|Subjects with diagnosis of Eisenmenger Syndrome|"Antibiotic recommendation for SBE prophylaxis and influenza vaccine
~Contraception counseling, and recommendations regarding avoidance of pregnancy
~Documentation and prescription of the specific medications:
~Oxygen
~Diuretic
~ASA, Anticoagulant
~CCB, BB, ACEI, ARB
~Iron Supplementation
~Allopurinol
~PAH specific therapy"
16170121|NCT01623479|Drug|bimatoprost 0.03%|Subjects with hypotrichosis of the eyelashes using bimatoprost 0.03% (Latisse®) as prescribed by physician for at least 12 months
16170122|NCT01623466|Drug|levonorgestrel|transdermal contraceptive delivery system
16170123|NCT01623453|Biological|Autologous adipose derived stem cells(low dose group)|low dose group: 1x10e7 cells/mL At 6 weeks after first stem cell injection, fistula closing was assessed. If it is not completely closed, second injection would be applied in 2 weeks. Additional dosage would be doubled to first dosage.
16170124|NCT01623453|Biological|Autologous adipose derived stem cells(high dose group)|high dose group: 2x10e7 cells/mL At 6 weeks after first stem cell injection, fistula closing was assessed. If it is not completely closed, second injection would be applied in 2 weeks. Additional dosage would be doubled to first dosage.
16170125|NCT01623440|Combination Product|Placebo and fMRI|Pill form, participant dosed one time an hour before fMRI.
16170126|NCT01623440|Combination Product|Naltrexone and fMRI|50 mg pill given one time, one hour before fMRI
16170127|NCT01623427|Procedure|Application of vacuum|The vacuum will be applied to the wound dressing of the umbilical port site using a 22 g needle on a 10 ml syringe passed percutaneously from the outside of the dressing into the gauze and the air around the gauze is evacuated.
16170128|NCT01623427|Procedure|No vacuum|Except for the vacuum, the wound dressing for the umbilical port site will be the same. No vacuum will be applied to the wound dressing of this group
16170129|NCT01623401|Drug|TR-701 FA|TR-701 FA 200 mg once daily
16170130|NCT01623388|Procedure|Oral glucose tolerance test for Phase I|Oral glucose tolerance test for Diabetic patients in phase I
16170131|NCT01623375|Drug|insulin degludec|A single dose of 0.4 U/kg body weight will be administered subcutaneously (s.c., under the skin).
16170132|NCT01623375|Drug|insulin degludec|A single dose of 0.04 U/kg body weight will be administered intravenously (i.v., into the vein).
16170133|NCT01623362|Other|Low-fluoride acidic dentifrice|550 ppm (mg/L) of sodium fluoride in pH 4,5; 12 months , 3 times a day.
16170134|NCT01623362|Other|conventional dentifrice|1100 ppm (mg/L) of sodium fluoride, pH 7 , 3 times a day for 12 months
16170135|NCT01623362|Other|neutral pH and low-fluoride dentifrice|500 ppm sodium fluoride, pH 7 , 3 times a day for 12 months
16170136|NCT01623349|Drug|BKM120 and Olaparib|Olaparib twice daily (starting dose 50 mg) and BKM120 once daily (starting dose 40 mg). Both drugs are given orally.
16170137|NCT01623349|Drug|BYL719 and Olaparib|Olaparib twice daily (starting dose 100 mg) and BYL719 once daily (starting dose 250 mg). Both drugs are given orally.
16170138|NCT01623336|Drug|BIP 48 (Peginterferon alfa 2b 48kDA)|BIP 48 (Peginterferon alfa 2b 48kDA)will be administered in a dose of 180 micrograms, once a week, subcutaneous, for 24 to 48 weeks to genotypes 2 and 3, and for 48 to 72 weeks to genotype 1.
16170139|NCT01623336|Drug|Peginterferon alfa 2a 40kDA|Patients will receive Pegasys ® in a dosage of 180 micrograms, once a week, subcutaneous, for 24 to 48 weeks to genotypes 2 and 3 and for 48 to 72 weeks to genotype 1.
16170140|NCT01623336|Drug|BIP 48 (Peginterferon alfa 2b 48kDA)|Patients will receive BIP 48 in a dosage of 180 micrograms, once a week, subcutaneous, for 24 to 48 weeks to genotypes 2 and 3 and for 48 to 72 weeks to genotype 1.
16170141|NCT01623323|Drug|Fluticasone Propionate|Fluticasone Propionate 400 μg
16170142|NCT01623310|Drug|Fluticasone Propionate|Using Optinose Exhalation Delivery System
16170143|NCT01623284|Drug|C-11 PiB|One time intravenous administration of 740 megabecquerel (MBq) of [N-methyl-11C]2-(4'-methylaminophenyl)-6-hydroxybenzothiazole (PiB) (range 370 - 740 MBq).
16170144|NCT01623284|Drug|F-18 FDG|One time intravenous administration of 629 megabecquerel (MBq) of [18-F]-fluoro-deoxy-glucose (FDG) (range 555 - 740 MBq).
16170145|NCT01623271|Drug|Gabapentin|
16170146|NCT01623232|Biological|MAS-1 adjuvant and influenza HA antigen|"Vaccines will be administered IM in the deltoid muscle. HA antigen of each of three viral strains at doses of 1 micrograms, 3 micrograms, or 5 micrograms per viral strain adjuvanted with MAS-1 adjuvant and as nonadjuvanted standard dose TIV will be tested.
~Treatment Group 1:each 0.3 mL dose will be administered as an emulsion containing 0.186 grams of MAS-1 oil vehicle and 1 micrograms HA of each of three viral strains in 0.08 mL sterile phosphate buffered saline (PBS).
~Treatment Group 2:each 0.3 mL dose will be administered as an emulsion containing 0.186 grams of MAS-1 oil vehicle and 3 micrograms HA of each of three viral strains in 0.08 mL sterile PBS.
~Treatment Group 3:each 0.3 mL dose will be administered as an emulsion containing 0.186 grams of MAS-1 oil vehicle and 5 micrograms HA of each of three viral strains in 0.08 mL sterile PBS."
16170147|NCT01623232|Biological|standard dose, inactivated trivalent influenza vaccine (TIV)|"Vaccine will be administered IM in the deltoid muscle. HA antigen of each of three viral strains as nonadjuvanted standard dose TIV will be tested.
~4. Treatment Group 4:0.5 mL dose of licensed, unadjuvanted, standard dose influenza virus vaccine with 15 micrograms HA of each of 3 viral strains."
16170148|NCT01623219|Behavioral|Prolonged Exposure Therapy|Exposure therapy refers to several cognitive behavioral treatment programs that involve confronting feared but safe thoughts, images, objects, situations, or activities in order to reduce unrealistic fear and anxiety. Exposure therapy for PTSD involves prolonged, imaginal exposure to the patient's traumatic memory and in vivo (in real life) exposure to trauma reminders. Prolonged exposure (PE) is a specific exposure therapy program that consists of five components: (1) psychoeducation (2) training in controlled breathing, (3) prolonged imaginal exposure to the trauma memory conducted in therapy sessions and repeated as homework, (4) prolonged in vivo exposure implemented as homework, and (5) processing of the traumatic material to correct maladaptive cognitions.
16170149|NCT01623206|Drug|Desmopressin|"Dose groups: Group 1: 0.25 µg/kg/day; Group 2: 0.25 µg/kg/12 hours; Group 3: 0.50 µg/kg/12 hours; Group 4: 1 µg/kg/day; Group 5: 1 µg/kg/12 hours; Group 6: 2 µg/kg/day.
~All groups will receive desmopressin intravenously, in a 15-20 minutes infusion, one or two times a day. The administration will be repeated 24 hours after the first infusion."
16170150|NCT01623193|Other|All-blood cardioplegia|The treatment group will receive all-blood cardioplegia for myocardial protection during surgery
16170151|NCT01623193|Procedure|Standard cardioplegia|This arm will receive standard 4:1 cardioplegia for myocardial protection during surgery
16170152|NCT01623180|Device|Biofreedom™ Drug Coated Stent (DCS)|Biofreedom DCS implantation in high risk bleeding patients followed by 1 month DAPT
16170153|NCT01623180|Device|Gazelle™ Bare Metal Coronary Stent (BMS)|Gazelle BMS implantation in high risk bleeding patients followed by 1 month DAPT
16170154|NCT01623167|Drug|Cohort 1: hATG, CsA, EPAG Day 14 to Month 6|hATG (standard of care) administered for 4 days, CsA (standard of care) administered starting day 1 for 6 months, eltrombopag (experimental) administered Day 14 to month 6
16170155|NCT01623167|Drug|Cohort 2: hATG, CsA, EPAG Day 14 to Month 3|hATG (standard of care) administered for 4 days, CsA (standard of care) administered starting day 1 for 6 months, eltrombopag (experimental) administered Day 14 to month 3
16170156|NCT01623167|Drug|Cohort 3: hATG, CsA (dose reduced), EPAG day 1 to month 6|hATG (standard of care) administered for 4 days, CsA (standard of care) administered starting day 1 for 6 months at higher dose, then reduced dose for 18 months, eltrombopag (experimental) administered Day 1 to month 6
16170157|NCT01623167|Drug|Extension Cohort|Receive horse ATG days 1- 4, receive CsA day 1 to month 6 at higher dose, then reduced dose for 18 months, and receive eltrombopag day 1 to month 6
16170158|NCT01623154|Other|Pranactin citric solution|All patients were required to drink the pranactic citric solution to diagnose H.pylori.
16170159|NCT01623141|Procedure|Pressure Pain measurement|The pressure pain thresholds were established using a manual pressure algometer. The investigated joints were the carpus, the metacarpophalangeal and the proximal interphalangeal joints
16170160|NCT01623128|Behavioral|Prenatal video|Participants are randomized to view either the intervention video or a sham video.
16170161|NCT01623115|Drug|Alirocumab|Solution for subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre filled pen).
16170162|NCT01623115|Drug|Placebo (for alirocumab)|Solution for subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre filled pen).
16170163|NCT01623115|Drug|Lipid Modifying Therapy (LMT)|Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.
16170164|NCT01623102|Drug|cisplatin and gemcitabine combination with Bevacizumab|Patients receive gemcitabine and cisplatin chemotherapy combined with Bevacizumab every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Gemcitabine 1250mg/m2 d1, d8, cisplatin 75mg/m2 d1, Bevacizumab 7.5 mg / kg every 21 days.
16170165|NCT01623102|Drug|Gemcitabine combined with cisplatin chemotherapy|Patients receive gemcitabine combined with cisplatin chemotherapy every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Gemcitabine 1250mg/m2 d1, d8, + cisplatin 75mg/m2 d1.
16170166|NCT01623063|Procedure|Hysteroscopy|hysteroscopy with guided biopsies
16170167|NCT01623050|Device|SinuSys Dilation System|Sinuplasty
16170168|NCT01623037|Device|The Zeltiq System|Non-invasive cooling is applied to the each flank with a defined cooling rate and duration.
16170169|NCT01623024|Drug|Vitamin D|20.000 UI/week for 96 weeks
16170170|NCT01623024|Behavioral|Lifestyle counseling|Lifestyle counseling for 96 weeks
16170171|NCT01623011|Procedure|Arthroscopic Sub-acromial Decompression Surgery|The procedure involves insertion of the arthroscope into the glenohumeral joint where the joint surface is inspected along with the intra-articular portion of the long head of biceps and the joint surface of the rotator cuff tendons. The arthroscope is then inserted into the sub-acromial bursa which lies outside the rotator cuff tendons and beneath the acromion process of the scapula. In the bursa the acromion and superior surface of the rotator cuff are assessed to ensure the coracoacromial ligament and the AC joint remains intact. The projecting under surface of the distal part of the acromion is resected.
16170172|NCT01623011|Procedure|Shoulder Arthroscopy|This is the surgical comparison group. The procedure is performed under general anaesthetic. Patients will undergo a routine investigational arthroscopy. The operation will be performed in exactly the same manner as Group ASAD. The exception is they will not undergo the decompression (bone spur removal). Tissues will be visualised and the joint will be washed out. The time spent in theatre will be similar to that for Group ASAD. These measures provide the AO group with the characteristics necessary to provide a reasonable comparison and account for the placebo effects of surgery.
16170173|NCT01623011|Other|Active Monitoring with Specialist Reassessment|Patients will be advised that they will undergo active monitoring in the short term. They will attend a reassessment appointment 3 months after entering the study. Here, they will be asked to complete questionnaires related to their shoulder pain and undergo a clinical assessment for their shoulder. From an ethical standpoint it is emphasised that it is quite within normal practice to have a period of active monitoring.
16170174|NCT01622998|Drug|NicoDerm Patch|"Dosage: 21mg patch; 14mg patch; 7 mg patch Frequency: NRT patch application once per day Duration: 10 week treatment period
~*Titration for experimental group (NRT+) based on smoking history, and option to increase dose if withdrawal symptoms are unmanageable."
16170175|NCT01622998|Drug|Nicorette Inhaler|Nicorette Inhaler: Box, 42 cartridges (4mg/cartridge) Dosage: Ad libitum Maximum dosage: 6-12 cartridges/day
16170176|NCT01622972|Drug|Polyethyleneglycol|Group 1 sachet's A and B made up to 1 litre with tap water once on day 1 and once on day 2. Group 2 2x sachet's A and B made up to 2 litres with tap water on day 1. Group 3 sachet's A and B made up to 1 litre with tap water once on day 1.
16170177|NCT01622959|Procedure|Acupuncture|"-Group Acupuncture: Receiving protocol of acupuncture. Acupuncture is performed by a trained certificied resident.
~The protocols, which allow acupuncture points to be selected from a pool of pre-determined points for each condition, provide sufficient standardization to assist replication, yet are flexible enough to allow individualized treatments. These protocols also allow for additional points, such as 'ashi points', to be used at the discretion of the acupuncturist. The location of the points, angle of insertion and depth of insertion were sourced from a popular text 'A Manual of Acupuncture'.
~-Group Morphine: Receiving 5mg of morphine followed by intravenous administration of 2,5 mg morphine each 5 min, until VAPS becomes <30%. Treatment failure is defined as VAPS>30 %, 30min after beginning of the protocol. In this case, analgesic treatment was administered according to the treating physician discretion."
16170178|NCT01622946|Drug|Tranexamic Acid|3g of tranexamic acid is topically applied after THA. The drugs is left for 15 minutes or 2 hours
16170179|NCT01622946|Drug|placebo|The patients will receive 3g topical TXA for 15 minutes or 2 hours after THA. 33% of the patients will receive 3g of TXA trough a suction drain for 15 minutes after total hip arthroplasty, then the suction drain is opened. 33% will receive the same amount of TXA but the suction drain will only be opened 2 hours after application. The other patients will receive a placebo in the same manner
16170180|NCT01622933|Biological|DC Vaccine + IFN|"Vaccine: The dose target is 1x10e7 AdVTMM2/DC per intradermal injection, or lower dose per sponsor's discretion.
~IFN: 20 MU/m²/d (rounded to the nearest 1.0 million unit) administered IV x 5 consecutive days out of 7 (M-F) every week x 4 weeks."
16170181|NCT01622933|Biological|AdVTMM2/DC Vaccination|Vaccine: The dose target is 1x10e7 AdVTMM2/DC per intradermal injection.If cell counts are below the target, as few as 5x10e6 AdVTMM2/DC may be administered. However, at the discretion of the sponsor and/or the treating physician, a lower dose of DC that fulfills all of the other criteria for release may be administered on a case by case basis. If this occurs a dose exception form will be completed by the IMCPL, signed by the treating physician and filed in the subjects research records.
16170182|NCT01622920|Other|Ultrasound transducer|A hand-held ultrasound transducer will be placed on a central incisor and enamel thickness measurements recorded
16170183|NCT01622881|Drug|Normal saline|Normal saline 200mL : the infusion of 4mL/hr for post-operative 48 hours
16170184|NCT01622881|Drug|Nefopam|Nefopam 160mg (16 mL) mixed to normal saline 184 mL : the infusion of 4mL/hr for post-operative 48 hours
16170185|NCT01622868|Other|Laboratory Biomarker Analysis|Correlative studies
16170186|NCT01622868|Drug|Lapatinib Ditosylate|Given PO
16170187|NCT01622868|Radiation|Stereotactic Radiosurgery|Undergo SRS
16170188|NCT01622868|Radiation|Whole-Brain Radiotherapy|Undergo WBRT
16170189|NCT01622855|Behavioral|PPRS|Video including psycho-education and modeling of adaptive behavioral coping strategies for use post-assault.
16170190|NCT01622829|Procedure|"Prescription for Activity and individual instructions"|"Structured education. Prescription for Activity. This contains an exercise programme which consists of a 30 minutes muscle strengthening exercises to be performed at home at least three times per week and an endurance sports, chosen by the patient, to be performed at least 2 times per week. Additional the physiotherapists advise them in being more active during their individual daily life ( e.g. using a bike for short distances, regular walking, abandon the lift/escalator)."
16170191|NCT01622829|Other|"Prescription for Activity, without instructions"|"Prescription with exercise programme. Prescription for activity. This contains an exercise program consisting of 30 minutes of muscle strengthening exercises to be performed at home at least three times per week, the patient also needs to perform in an endurance sport at least two times per week."
16170192|NCT01622829|Other|usual physiotherapy|physiotherapy, treatment as usual
16170193|NCT01622803|Procedure|parallel stent|bilateral parallel stent insertion (right and left side)
16170194|NCT01622803|Device|Y-stent (BONASTENT M-Hilar)|Bilateral Y-stent insertion (stent in stent type)
16170195|NCT01622790|Drug|Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg|Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg is an experimental fixed dose combination tablet of an experimental integrase inhibitor (dolutegravir) and two FDA approved nucleoside reverse transcriptase inhibitors (abacavir and lamivudine)
16170196|NCT01622790|Drug|Dolutegravir 50 mg|Dolutegravir is an experimental drug in the integrase inhibitor class that is being studied for the treatment of HIV infection.
16170197|NCT01622790|Drug|abacavir 600 mg/lamivudine 300 mg|This is an FDA approved fixed dose combination tablet of two nucleoside reverse transcriptase inhibitors
16170198|NCT01622777|Drug|Rosuvastatin|20 mg daily of oral rosuvastatin for 12 weeks
16170199|NCT01622777|Drug|Placebo|100 mg of oral placebo with identical appearance, form and size than rosuvastatin, one tablet daily for 12 weeks
16170200|NCT01622764|Radiation|Molecular imaging with 89Zr-RO5323441|Bevacizumab at a dose of 10 mg/kg body weight i.v. in 90 min on day 1 will be given every 2 weeks in cycles of 6 weeks, until documented disease progression, unacceptable toxicity, patient refusal or patient's best interest. 89Zr-RO5323441 will be administered i.v. at a tracer dose of 5 mg (37 MBq) on day -3 and on day 11 of cycle 1 of bevacizumab treatment. Four PET scans will be performed (2 brain only PET scans and 2 whole body PET scans). Brain only PET scans will be performed 2 hours after each 89Zr-RO5323441 administration on day -3 and day 11. Whole body PET scans will be performed 4 days after each 89Zr-RO5323441 administration (before dosing with bevacizumab on day 1 and day 15).
16170201|NCT01622725|Procedure|Placing the resorbable mesh|Surgery for primary and secondary ventral hernia repair with placing of resorbable mesh.
16170202|NCT01622725|Procedure|Non-resorbable synthetic mesh.|Surgery for primary and secondary ventral hernia repair with placing of non-resorbable synthetic mesh.
16170203|NCT01622712|Device|Rebound HRD Mesh|Patients with unilateral inguinal hernia receive a nitinol containing large pore polypropylene mesh.
16170204|NCT01622699|Device|Transcutaneous Bilirubinometer|If a baby is jaundiced, the ward-nurse will perform a transcutaneous bilirubin measurement. It takes about 5 seconds to perform the measurement at the forehead or sternum of the baby. The device is a validated measurement-tool, which provides us with an estimated serum bilirubin-concentration. This is not an invasive procedure: A light-reflection is used to measure transcutaneous bilirubin.
16170205|NCT01622699|Other|visual assessment of neonatal jaundice|To detect newborns with jaundice (who will possibly meet the criteria for phototherapy) there have been international guidelines formulated by the American Academy of Pediatrics. The standard of care at the neonatal- and maternity ward of our hospital to detect those newborns is visual assessment according to these guidelines.
16170206|NCT01622686|Behavioral|PictureRx medication label|Reformatted medication labels that adhere to current best practices for label design and also include illustrations
16170207|NCT01622673|Drug|Raltegravir|"Raltegravir 400 mg oral tablet taken with 240 mL water every 12 hours
~Throughout the study, participants will continue to take raltegravir along with their other HIV medications. On the day of co-dosing and intensive pharmacokinetic (PK) sampling, raltegravir will be dosed in the morning in a fasted state in all periods."
16170208|NCT01622673|Drug|TUMS® Ultra Strength|"3 tablets TUMS® Ultra Strength (US) 1000 mg
~Throughout the study, participants will continue to take raltegravir every 12 hours along with their other HIV medications. There will be a minimum of 2 days washout between treatment periods. On the day of co-dosing and intensive PK sampling, raltegravir will be dosed in the morning in a fasted state in all periods."
16170209|NCT01622673|Drug|MINTOX® Maximum Strength|"20 mL MINTOX® Maximum Strength (MS)
~Throughout the study, participants will continue to take raltegravir every 12 hours along with their other HIV medications. There will be a minimum of 2 days washout between treatment periods. On the day of co-dosing and intensive PK sampling, raltegravir will be dosed in the morning in a fasted state in all periods."
16172014|NCT01608087|Drug|bevacizumab|bevacizumab single i.v. infusion
16170210|NCT01622660|Drug|Gemcitabine|Patients will receive gemcitabine 1200 mg/m2 intravenously on day 1 and day 8 and. Patients will receive 6 cycles of combination therapy (gemcitabine and pazopanib) unless disease progression or unacceptable toxicity occurs. Patients that achieve stable disease, a partial response, or a complete response after completion of 6 cycles, and who are not candidates for consolidation surgery, will be eligible to continue pazopanib monotherapy at the same dose and schedule until disease progression for a maximum of 18 additional cycles.
16170211|NCT01622660|Drug|Pazopanib|pazopanib 800 mg orally daily day 1 through day 21 (1 cycle = 21 days) Patients will receive 6 cycles of combination therapy (gemcitabine and pazopanib) unless disease progression or unacceptable toxicity occurs. Patients that achieve stable disease, a partial response, or a complete response after completion of 6 cycles, and who are not candidates for consolidation surgery, will be eligible to continue pazopanib monotherapy at the same dose and schedule until disease progression for a maximum of 18 additional cycles.
16170212|NCT01622647|Other|Nasal Continuous Positive Airway Pressure (NCPAP)|Subjects will receive NCPAP
16170213|NCT01622634|Behavioral|Sprint Interval Exercise|Participants will undergo sprint interval training on a cycle ergometer 3 times weekly for 6 weeks. Each training session begins with a 5-minute active warm-up. The warm-up is followed by 4-7 bouts of 30 seconds of all-out sprints and 4 minutes of active recovery.
16170214|NCT01622634|Other|Higher PRO Diet|Participants in the PRO and PRO+EX groups will meet weekly with a diet specialist on staff to monitor their intake and compliance with the high protein diet.
16170215|NCT01622634|Other|Higher CARB Diet|Participants in the CHO and CHO+EX groups will meet weekly with a diet specialist on staff to monitor their intake and compliance with the higher carbohydrate diet.
16170216|NCT01622621|Procedure|Sublobar Resection|Undergo surgery which removes a sublobar resection of the lung
16170217|NCT01622621|Radiation|Stereotactic Body Radiotherapy (SBRT)|54 Gy in 3 fractions
16170218|NCT01622608|Behavioral|Vaccine Information Kiosk|The study kiosk will remain in the waiting room of participating practices for the duration of the study. Interested parents will self-direct to the kiosk in the clinic waiting room either before or after their child's appointment. Following consent, parents will complete a survey that assesses socio-demographics, baseline vaccination intention, and vaccine-specific beliefs, attitudes and experiences. The kiosk will generate tailored educational messages about adolescent vaccines. Parents can utilize the kiosk as many times as they wish during the intervention period.
16170219|NCT01622569|Drug|Fluticasone Propionate|Delivered via Optinose Exhalation Delivery System
16170220|NCT01622556|Drug|Fludarabine|35 mg/m2 IV/day x 5 days
16170221|NCT01622556|Drug|Busulfan|.8 mg/kg IV Q6h x 8 doses
16170222|NCT01622556|Drug|Thymoglobulin|1.5 mg/kg/day x 3 days
16170223|NCT01622556|Radiation|Total Body Irradiation|150 cGy for 2 days
16170224|NCT01622556|Biological|Umbilical Cord Blood|Two partially HLA-matched UCB units. Each unit must match at a minimum of 4 of 6 at HLA-A, -B, -DRB1 loci with the recipient.
16170225|NCT01622543|Drug|Folfox plus Bevacizumab and reolysin|FOLFOX6/bevacizumab given every 14 days plus reolysin days 1-5 on cycles 1, 2, 4, 6, 8 and alternate cycles thereafter
16170226|NCT01622543|Drug|Folfox plus Bevacizumab|FOLFOX6/bevacizumab given every 14 days.
16170227|NCT01622504|Drug|MVP005|2 mg single dose administered intranasally
16170228|NCT01622504|Drug|MVP005|4 mg single dose administered intranasally
16170229|NCT01622504|Drug|Naloxone hydrochloride solution for injection with mucosal atomization device|2 mg single dose administered intranasally
16170230|NCT01622478|Procedure|Sentinel lymph node biopsy|Sentinel lymph node biopsy after neoadjuvant chemotherapy for the patients with clinically positive-nodes at presentation
16170231|NCT01622478|Drug|Neoadjuvant chemotherapy|Neoadjuvant chemotherapy for breast cancer patients with clinically positive-node at initial diagnosis
16170232|NCT01622478|Procedure|complete axillary lymph node dissection|Complete axillary lymph node dissection after sentinel node biopsy for estimation of false-negative rate of sentinel node biopsy
16170233|NCT01622478|Procedure|positron emission tomography and ultrasonogram|Routine evaluation of axillary nodal status using 18-fluorodeoxyglucose positron emission tomography and ultrasonogram before and after chemotherapy
16170234|NCT01622465|Behavioral|Ergometer cycling|Patients will participate of the exercises program with ergometer cycling and conventional exercises. The program will initiate after two weeks of the postoperative and will continue until three months of the postoperative
16170235|NCT01622465|Behavioral|Conventional exercises|Patients will participate only of the conventional exercises program. The program will initiate after two weeks of the postoperative and will continue until three months of the postoperative
16170236|NCT01622439|Drug|Valproate|Valproate is given in escalating doses to establish maximum tolerable dose when given together with standard treatment in patients with diffuse large B-cell lymphoma; this is the phase I part of the study. When maximum tolerable dose is established, this dose will be given to remaining patients in the phase II part of the study.
16170237|NCT01622439|Drug|Rituximab|Vill be given intravenously, 375 mg/m2, every second or third week depending on cycle length (14 or 21 days), for a total of 6 cycles.
16170238|NCT01622439|Drug|Cyclophosphamide|Vill be given intravenously, 750 mg/m2, every second or third week depending on cycle length (14 or 21 days) for a total of 6 cycles.
16170239|NCT01622439|Drug|Doxorubicin|Vill be given intravenously, 50 mg/m2, every second or third week depending on cycle length (14 or 21 days), for a total of 6 cycles.
16170240|NCT01622439|Drug|Vincristine|Vill be given intravenously, 1.2 mg/m2, every second or third week depending on cycle length (14 or 21 days), for a total of 6 cycles.
16170241|NCT01622439|Drug|Prednisone|Vill be given orally, 50 mg/m2, day 1-5 every cycle, for a total of 6 cycles.
16170242|NCT01622426|Dietary Supplement|tolerance to a new aminoacid based formula|Every 20 minutes, successive doses (0.1, 0.3, 1, 3, 10, 30 and 100 mL) of placebo (the commercially available Aaf Neocate, Nutricia, Milan, Italy) or of the study formula (Sineall, Humana, Milan, Italy) were administered.
16170243|NCT01622426|Dietary Supplement|Amino acid formula|Every 20 minutes, successive doses (0.1, 0.3, 1, 3, 10, 30 and 100 mL) of placebo (the commercially available Aaf Neocate, Nutricia, Milan, Italy) or of the study formula (Sineall, Humana, Milan, Italy) were administered.
16170244|NCT01622413|Procedure|joimax TESSYS|Transforaminal Endoscopic Surgery System
16170245|NCT01622413|Procedure|Microdiscectomy|Standard procedure for disc surgery
16170246|NCT01622400|Other|Therapeutic education HTA Vasc|The intervention program takes place in 3 phases. First, the education team realizes an individual educational diagnosis to define the objectives of the intervention according to each patient's needs. Secondly, patients assist to 3 to 5 group sessions lasting 2 hours with a dedicated nurse focusing on medical therapy explanation and blood pressure self measurement education - and with a dedicated nutritionist focusing on stress management and nutrition program. Patients can also have individual consultations with the dedicated nutritionist. Finally, an individual assessment permits to evaluate the benefits of the program for each patient and to define new objectives.
16170247|NCT01622387|Procedure|Coronary artery bypass (CABG) surgery using a radial arterial conduit|Use of radial artery as a bypass conduit/graft to the left circumflex coronary artery region of the heart in CABG surgery
16170248|NCT01622387|Procedure|Coronary artery bypass surgery using a long saphenous vein conduit|Use of long saphenous vein as a graft/conduit vessel to the left circumflex coronary artery region of the heart in CABG surgery
16170249|NCT01622374|Behavioral|Music|Ten minutes of music or silence were applied prior to dental procedures
16170250|NCT01622361|Drug|Adriamycin+Cyclophosphamide>Docetaxel|"Adriamycin 60mg/m2 + Cyclophosphamide 600mg/m2
~Route: by slow intravenous bolus
~Schedule: every 3weeks for 4 cycle
~Docetaxel 75mg/m2
~Route: intravenous as per local practice
~Schedule: every 3weeks for 4 cycle"
16170251|NCT01622361|Drug|GnRHa with Tamoxifen|"Goserelin(GnRHa) 3.6mg
~Route: subcutaneously under the abdominal skin
~Schedule: every 4weeks for 6cycles (period of 34 days between 2 administrations must not be exceeded)
~Tamoxifen 20mg/day
~Route: Oral
~Schedule: everyday"
16170252|NCT01622348|Drug|IMO-3100 at 0.16 mg/kg|IMO-3100 at 0.16 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 20 mg per injection
16170253|NCT01622348|Drug|Saline for Injection|Saline for Injection 0.01 mL/kg SC q wk x 4 wk based on body weight at screening, not to exceed 1.25 mL
16170254|NCT01622348|Drug|IMO-3100 at 0.32 mg/kg|IMO-3100 at 0.32 mg/kg SC q wk x 4 wks based on body weight at screening, not to exceed 40 mg per injection
16170255|NCT01622335|Drug|Nitrous oxide|General anesthesia with Nitrous Oxide, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.
16170256|NCT01622335|Other|General anesthesia with oxygen|General anesthesia with(Air, 70%, O2 30%) 1-5 L, Sevoflurane 1-2%, ETCO2: 32-35 mmHg.
16170259|NCT01622309|Dietary Supplement|eggplant meal|13 g meal of eggplant/day, being 6,5 g in breakfast and 6,5g in dinner
16170260|NCT01622309|Other|cassava meal|13g cassava meal/day,being 6,5 g in breakfast and 6,5g in dinner
16170261|NCT01622296|Drug|Sodium bicarbonate|8.4% neutralizing solution
16170262|NCT01622296|Drug|Lidocaine|2% lidocaine with 1:100,000 ppm epinephrine
16170263|NCT01622283|Drug|Levocetirizine|Levocetirizine
16170264|NCT01622283|Drug|Cetirizine|Cetirizine
16170265|NCT01622270|Other|Indirect calorimetry, body composition , blood tests,3 days food records,Crohns disease activity index|Indirect calorimetry test by a indirect calorimeter (OHMEDA) body composition by a DEXA machine blood tests, 3 days food records, Crohns disease activity index
16170266|NCT01622257|Device|Cavitation US|The areas with localized fat are treated 2 times per week for 3 months using Aesthetic cavitation via ultrasonic cavitation machine (Cavi SMART, South Korea, supplied with one piece cavitation probe of 40 KHz, 3-6 watt(W)/cm^2 adjustable, 60W with 20cm^2 active surface).
16170267|NCT01622257|Drug|Metformin|Metformin hydrochloride (Glucophage 500 mg/tablet, Bristol-Myers Squibb, New York, USA). Medication is initiated in a step-up fashion every 5 days, from one tablet per day to three. This dose is maintained as tolerated throughout the 3 months of the study.
16170268|NCT01622257|Other|Cavitation US + Metformin|Combination of both Cavitation US + Metformin. the treatment duration lasts 3 months
16170269|NCT01622244|Other|Co-ordinated Access to Care from Hospital Emergency Departments|brief, intensive case management for frequent users of hospital Emergency Departments who have mental health and/or addictions problems
16170270|NCT01622244|Other|Coordinated Access to Care from Hospital Emergency Departments|Participants will receive brief, intensive case management to connect them to health and social services and supports in the community
16170271|NCT01622244|Behavioral|Counseling and Resource Education|Participants will receive usual care as well as an educational session and resource guide outlining community-based services
16170272|NCT01622231|Drug|Fluticasone furoate|55 mcg/day, intranasal, 12 weeks
16170273|NCT01622218|Behavioral|Medical Clown|Presence of clowns on child's postoperative pain levels, anxiety levels of the child and the accompanying parent and the effect of the intervention on the total consumption of analgesics and on the post- surgery inflammatory markers
16170274|NCT01622205|Other|Very early supported discharge (VESD)|A rehabilitation team made up of physiotherapists, occupational therapists and a stroke nurse from the stroke care unit continues the rehabilitation in the patient's home. The intervention has a person-centered approach which is based on who the person is: their context, their history, their next of kin, their individual strengths and weaknesses (28). Goal setting using questions as in the Canadian Occupational Performance Measure (29) takes part before the discharge. Examples of goals can be: to be able to go to the local store to buy milk, to be able to hang the laundry or to be able to travel on the tram to the daughter or how to manage the bills.
16170275|NCT01622205|Other|Ordinary rehabilitation|Ordinary rehabilitation
16170276|NCT01622192|Device|Florida Probe automated probe|Comparisons between the reproducibility of readings taken by an automated probe and a manual probe
16170277|NCT01622179|Procedure|sewed indirectly|The epitenon was repaired and sewed indirectly.
16170278|NCT01622179|Procedure|sewed directly|The epitenon was unrepaired and sewed directly.
16170279|NCT01622166|Behavioral|psychodynamic art therapy|2 sessions à 1.5 hrs /week, intervention duration 6 weeks
16170280|NCT01622153|Procedure|Formocresol application after pulpotomy preparation|1:5 Buckley's Formocresol dilution applied for 5 minutes or until hemostasis achieved
16170281|NCT01622153|Procedure|GENTLEray 980 Soft Tissue diode laser|Application to pulp chamber until hemostasis achieved
16170346|NCT01621477|Drug|clofarabine|Given on Day -9 and Day -8 (Day 0 is first stem cell infusion). Drug class: antineoplastic agent
16170282|NCT01622127|Device|Parietex ProGrip™|ProGrip™ mesh is a lightweight (40g/m2) monofilament polypropylene or polyester mesh with resorbable polylactic acid (PLA) micro-grips, which provide self-gripping properties during the first few months after implantation.
16170283|NCT01622114|Other|Evaluation of the Association between the Menstrual Cycle and Weight Loss in Healthy, Overweight Premenopausal Women|2-arm parallel 6 month study with the obejective to examine the impact of the menstrual cycle on weight loss attempts in healthy overweight premenopausal women randomized to two different weight management programs. The women may not use hormonal contraceptive agents other than an IUD.
16170284|NCT01622101|Dietary Supplement|Thermogenic properties of Zantrex-3®|The present study was designed as a 2-arm randomised, placebo-controlled, double-blind crossover study. Each treatment was separated by >7 d washout period. Both treatments were administered as tablets. The Zantrex-3® compound contained yerba maté, caffeine, guarana, damiana, green tea, kola nut, schizonepeta, piper nigrum, ginseng, maca root, and cocoa nut. The content of xantines (caffeine and caffeine-like stimulants) accounted for 365 mg per serving (2 capsules) or 1095 mg (6 capsules) if given as a daily dose. The placebo supplement contained rice flower and could not be distinguished from the Zantrex-3® compound with regard to colour, taste, smell or ap-pearance.
16170285|NCT01622088|Drug|Dexpramipexole|Oral tablet 150 mg given twice daily up to 36 months
16170286|NCT01622075|Device|SeQuent® Please|SeQuent® Please with a length of 10mm,15mm,17mm,20mm and 26mm and diameter of 2.5 mm, 2.75 mm, 3.0mm, 3.5mm and 4.0mm are to be used in the trial
16170287|NCT01622075|Device|Taxus Liberte|Taxus Liberte with a length of 8mm,12mm,16mm,20mm and 24mm and diameter of 2.5 mm, 2.75 mm, 3.0mm, 3.5mm and 4.0mm are to be used in the trial
16170288|NCT01622062|Biological|PVRV|0.1 mL, 4 site 'one week' (4-4-4-0-0) administered intradermally
16170289|NCT01622062|Biological|PVRV and pERIG Favirab®|0.1 mL of vaccine administered intradermally in 4 site 'one week' (4-4-4-0-0) regimen, and pERIG Favirab® (volume to be calculated according to the patient' body weight) infiltrated into and around wound(s)
16170290|NCT01622062|Biological|PVRV and pERIG Favirab®|0.1 mL of vaccine administered intradermally in 2-site TRC (2-2-2-0-2) regimen, and pERIG Favirab® (volume to be calculated according to the patient' body weight) infiltrated into and around wound(s)
16170291|NCT01622049|Device|Selective Laser Photocoagulation of Communicating Vessels|Patients will be admitted to Tampa General Hospital. Laboratory tests and anesthesia assessments will be completed. Antibiotic prophylaxis is initiated within an hour of surgery and continued every 8 hours through the first post-operative day. Surgery will be performed preferably under local anesthesia for the mother using 1% xylocaine with epinephrine at the trocar entry site, and IV sedation. Surgery will be performed with standard operative fetoscopy equipment and techniques. A trocar will be introduced in the amniotic cavity of the recipient. An amniotic fluid sample will be obtained for microbiological studies, and genetic analysis for clinical care only. The amniotic fluid will be discarded after analysis. The communicating vessels will be located endoscopically and will be lasered with YAG laser energy. The procedure will be monitored both endoscopically and sonographically. The presence of fetal heart activity will be noted. An amniodrainage of the larger sac may be performed
16170292|NCT01622023|Procedure|intra-uterine insemination|Artificial insemination is the process by which sperm is placed into the reproductive tract of a female for the purpose of impregnating the female by using means other than sexual intercourse or natural insemination.
16170293|NCT01622010|Behavioral|Allied Health Education Class Option|An Allied Health Education Class is provided as part of standard care on an optional basis. It involves a one time attendance at a 90 minute class which provides basic education from a multidisciplinary team.
16170294|NCT01622010|Other|Physiotherapy treatment intervention on referral|The option exists for referral to physiotherapy, according to standard protocol, for assessment and individual exercise prescription.
16170295|NCT01622010|Device|Keeping the Beat with Physiotherapy: Heart Failure edition|Educational DVD covering the basics of physiotherapy education for the patient with heart failure.
16170296|NCT01621997|Behavioral|operation inspection|"Retraining via operation inspection means that nurses check if patients can follow the taught skill during the procedure of bag exchange and correct wrong steps in one-to-one way every 2 months.
~Retraining via verbal education means that nurses remind patients of key points of bag exchange through interactive quiz derived from above checklist every 2 months till 24 months"
16170297|NCT01621984|Other|Therapeutic Riding/ Hippotherapy Intervention|The Therapeutic Riding exercise intervention consisted exercises for warm up,transitions on the horseback, stretching exercises and exercises to strengthen muscles of trunk and four limps, games with balls and rings and walking of the horse to change directions as diagonal / lateral changes, cycles with open and closed eyes.
16170298|NCT01621971|Drug|inhaled milrinone|After performing the sternotomy and achieving stable hemodynamics, but before the initiation of CPB, inhaled milirinone and intravenous placebo (0.9% normal saline 0.05 ml/kg) are administered
16170299|NCT01621971|Drug|intravenous milrinone|After performing the sternotomy and achieving stable hemodynamics, but before the initiation of CPB, inhaled placebo (distilled water) and an intravenous bolus of milrinone (50 μg/kg) are administered
16170300|NCT01621958|Behavioral|Repeated perturbation training|One session consisting of 24 slips total interspersed with 16 nonslip trials (1 block of 8 slips, 3 non-slips, 2nd block of 8 slips, 3 non-slips, a mixed block consisting of 8 slips and 10 non-slips). Retest consisting of one slip exposure at either 6 months, 9 months or 12 months.
16170301|NCT01621958|Behavioral|Minimal perturbation training|One session consisting of a single slip exposure. Retest consisting of one slip exposure at either 6 months, 9 months or 12 months.
16170302|NCT01621945|Biological|MenBvac|Blood test
16170303|NCT01621932|Procedure|Direct anterior approach with capsulectomy|Direct anterior approach with capsulectomy
16170304|NCT01621932|Procedure|Direct anterior approach without capsulectomy|Direct anterior approach without capsulectomy
16170305|NCT01621906|Device|18F-FLT-PET Imaging|"All patients will be imaged using FLT-PET scans at baseline (within 4 weeks of initiation of WBRT), 7-10 days after completion of WBRT and then 10-12 weeks after WBRT.
~Patients will also be evaluated with MRI imaging at baseline and then 10-12 weeks after WBRT.
~Patients will be followed with MRI every 3 months (+/- 7 days) for the first year and then every 6 months (+/- 7 days) thereafter which is the standard of care."
16170347|NCT01621477|Drug|cytarabine|Given on Day -9 and Day -8 (Day 0 is first stem cell infusion). Drug class: antineoplastic agent
16170306|NCT01621906|Device|18F-FLT-PET Imaging|"All patients will be imaged using FLT-PET scans at baseline (within 4 weeks of initiation of WBRT), 7-10 days after completion of WBRT and then 10-12 weeks after WBRT.
~Patients will also be evaluated with MRI imaging at baseline and then 10-12 weeks after WBRT.
~Patients will be followed with MRI every 3 months (+/- 7 days) for the first year and then every 6 months (+/- 7 days) thereafter which is the standard of care."
16170307|NCT01621893|Procedure|Subchondroplasty|
16170308|NCT01621880|Drug|bevacizumab|Patients receive bevacizumab 5mg/kg intravenously over 30-90 minutes on day1. Treatment repeats every 2 weeks for up to 4 courses in the absence of disease progression or unacceptable toxicity.
16170309|NCT01621880|Drug|Corticosteroid|Patients in the corticosteroid group were treated with intravenous pulsed-steroid therapy: methylprednisolone 500 mg daily intravenously for three consecutive days followed by oral prednisone 60 mg for five days and gradually tapered 15mg every 5 days. When the prednisone dose reached 30mg per day, it was tapered down more slowly (tapered 5mg every week), until a maintenance dose of 10mg per day was reached. The entire intervention lasted two months. At 2 months, prednisone was stopped.
16170310|NCT01621867|Drug|pGM169/GL67A|5ml Gene Product/Lipid Vector pGM169/GL67A nebulised; 2ml nasal application of pGM169/GL67A in addition to 5ml nebulised gene product (Nasal Subgroup)
16170311|NCT01621867|Drug|Placebo|5ml Nebulised non-active placebo; 2ml nasal administration of non-active placebo (nasal subgroup)
16170312|NCT01621854|Drug|NUC-1031|Cohort 1, Schedule A, NUC-1031 I.V. 1000mg/m2, Days 1, 8, & 15 every 28 days Cohort 1, Schedule B, NUC-1031 I.V. 500mg/m2, Days 1 & 5, 8 & 12, 15 &19 every 28 days Cohort 2, Schedule A, NUC-1031 I.V. 2000mg/m2, Days 1, 8, & 15 every 28 days Cohort 2, Schedule B, NUC-1031 I.V. 1000mg/m2, Days 1 & 5, 8 & 12, 15 &19 every 28 days
16170313|NCT01621828|Other|video|a video, showing the patient pathway to and from the Operating Theatre, about the operating room experience and environment.
16170314|NCT01621828|Other|leaflet|a written leaflet, about the operating room experience and environment.
16170315|NCT01621815|Behavioral|Video Game|Playing various video games: RPG, Race, FPS, Strategy
16170316|NCT01621802|Biological|Priorix|One dose administered subcutaneously in the triceps region of the right arm.
16170317|NCT01621802|Biological|M-M-R II|One dose administered subcutaneously in the triceps region of the right arm.
16170318|NCT01621802|Biological|Kinrix|One dose administered by deep intramuscular injection in the upper left deltoid.
16170319|NCT01621802|Biological|ProQuad|One dose administered subcutaneously in the triceps region of the left arm.
16170320|NCT01621789|Other|dye of lutein, zeaxanthin, trypan blue|dye composed of lutein, zeaxanthin, trypan blue
16170321|NCT01621776|Drug|Apidra|Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
16170322|NCT01621776|Drug|Humalog|Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
16170323|NCT01621776|Drug|Novolog|Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
16170324|NCT01621763|Drug|Clopidogrel|Clopidogrel Tablets 300 mg
16170325|NCT01621750|Drug|Clopidogrel|Clopidogrel Tablets 300 mg
16170326|NCT01621737|Drug|Oxytocin|42 IU BID for six weeks
16170327|NCT01621737|Drug|Oxytocin|84 IU BID for six weeks
16170328|NCT01621737|Drug|Placebo|Vehicle placebo
16170329|NCT01621724|Genetic|WT1 TCR-transduced T cells|"Two patient cohorts:
~Cohort 1 (up to 6 patients) = ≤ 2 x 107/kg WT1 TCR-transduced T cells
~Cohort 2 (12 patients)= ≤ 108/kg WT1 TCR-transduced T cells"
16170330|NCT01621711|Behavioral|Linkage patient activation intervention|"Usual Care plus Linkage encompassed Usual Care with the exception that the six 45-min Linkage patient activation education groups replaced the six 45-min Usual Care medical education groups, plus a linkage phone call (and/or a facilitated email) with the patient, clinician, and Primary Care physician.
~The patient activation intervention components -- 1) six 45-min Linkage sessions on activation regarding overall health behaviors and 2) a linkage phone call (and/or a facilitated email) with the patient, clinician, and PC physician -- were delivered by a clinical psychologist."
16170331|NCT01621698|Procedure|Early paravertebral block|In this group the local anaesthetic will be injected at the start of surgery soon after incision and normal saline at the end. These will be double blinded.
16170332|NCT01621698|Procedure|Late Paravertebral block.|In the late group local anaesthetic will be injected at close of surgery with normal saline at the start. This will be double blinded.
16170333|NCT01621685|Biological|biological/vaccine|Inhalation studies will immediately be terminated after a significant adverse response to a particular capsaicin dose and no further testing will occur.
16170334|NCT01621672|Drug|Revlimid|10 mg/day in the morning same time each day
16170335|NCT01621659|Behavioral|Multidisciplinary team intervention|Intervention arm receives regular assessments and treatments from cardiology team, clinical nutrition, pharmacist, exercise physiologist and physiotherapist
16170336|NCT01621646|Other|eggs or egg whites|2 eggs/day or 4 oz egg whites/day for 6 months
16170337|NCT01621633|Drug|LCZ696|
16170338|NCT01621620|Drug|Yohimbine|
16170340|NCT01621581|Genetic|Convection enhanced delivery/AAV2-GDNF|Adeno-Associated Virus Encoding Glial Cell Line-Derived Neurotrophic Factor (AAV2-GDNF) Administered via Bilateral Stereotactic Convection-Enhanced Delivery
16170341|NCT01621568|Drug|Sunitinib|50mg/day for 4 weeks daily, by mouth with 2 weeks off (6 week cycle)
16170342|NCT01621542|Biological|WT2725|WT2725 injection Study drug will be administered every 1-4 weeks
16170343|NCT01621503|Device|NT-530P|intraocular pressure and central corneal thickness measurement
16170344|NCT01621490|Biological|Nivolumab|
16170345|NCT01621490|Drug|Ipilimumab|
16170390|NCT01621191|Drug|Duloxetine|Administered Orally
16170348|NCT01621477|Drug|busulfan|Given on Day -7 and Day -6 (Day 0 is first stem cell infusion). Drug class: antineoplastic agent
16170349|NCT01621477|Drug|Plerixafor|Given on Day -7 and Day -6 (Day 0 is first stem cell infusion). Drug class: Hematopoietic Stem Cell Mobilizer
16170350|NCT01621477|Drug|cyclophosphamide|Given on Day -5 and Day +4 (Day 0 is first stem cell infusion). Drug class: antineoplastic agent; immunosuppressive agent.
16170351|NCT01621477|Drug|antithymocyte globulin (rabbit)|Given on Day -4, Day -3, Day -2, and Day -1 (Day 0 is first stem cell infusion). Drug class: immunosuppressive agent.
16170352|NCT01621477|Biological|stem cells|Patients undergo T cell replete Hematopoietic stem cell infusion on Day 0 and Day +1. Patients undergo natural killer (NK) cell transplantation on day +6 (Day 0 is first stem cell infusion).
16170353|NCT01621477|Drug|Tacrolimus|Given on Day +11 (Day 0 is first stem cell infusion). Drug class: immunosuppressive agent.
16170354|NCT01621477|Drug|mycophenolate mofetil|Given on Day +11 (Day 0 is first stem cell infusion). Drug class: immunosuppressive agent.
16170355|NCT01621464|Device|Pacemaker with Closed Loop Stimulation (CLS sensor)|Crossover: 1 year at control group and 1 year at CLS group (randomized which group goes first)
16170356|NCT01621451|Drug|aspirin and/or clopidogrel|Patients who have taken aspirin and/or clopidogrel and are found to have early gastric cancer or gastric premalignant lesions including adenoma and dysplasia by upper endoscopy will be stopped aspirin and/or clopidogrel for 7 days before EMR/ESD. In immediate group, the patient will receive oral proton pump inhibitor (pantoprazole 40mg per day) for 4 weeks after EMR/ESD to treat their post-EMR/ESD ulcer.
16170357|NCT01621451|Drug|aspirin and/or clopidogrel|"Patients who have taken aspirin and/or clopidogrel and are found to have early gastric cancer or gastric premalignant lesions including adenoma and dysplasia by upper endoscopy will be stopped aspirin and/or clopidogrel for 7 days before EMR/ESD.
~In 2 weeks group, the patient will receive oral proton pump inhibitor (pantoprazole 40mg per day) for 4 weeks after EMR/ESD to treat their post-EMR/ESD ulcer."
16170358|NCT01621425|Other|Lean body mass|Lean Body mass (DEXA scan and Bioelectrical Impedance Assessments) within one week prior to the first docetaxel dose
16170359|NCT01621425|Other|Total body weight|Total Body weight (TBW) (scale) within one week prior to the first docetaxel dose
16170360|NCT01621425|Other|bloodsampling|Blood samples will be taken during the first docetaxel administration of the first cycle, just before docetaxel infusion (t=0 min.), 30 min after start of infusion (t=30 min.), just prior to end of infusion (t=55 min.) and between 3 to 6 hours post start infusion following a limited sampling model
16170361|NCT01621399|Drug|Product 55394|Product 55394 vaginal gel in a prefilled applicator.
16170362|NCT01621399|Drug|Placebo Vehicle (non-treatment)|The vehicle vaginal gel in an applicator (placebo).
16170363|NCT01621386|Drug|Montelukast|Administered orally as a single daily 10 mg dose for 2 weeks
16170364|NCT01621386|Drug|Prednisone|Administered orally as a single daily 20 mg dose for 2 weeks
16170365|NCT01621373|Drug|propofol administration|Single IV bolus propofol start at 1 mg/kg. Dose will be adapted based on predefined scoring systems with +/-0.5 mg/kg.
16170366|NCT01621360|Procedure|Arthroscopic hip surgery|Hip arthroscopy
16170367|NCT01621360|Other|Physical therapy|Physical therapy aimed at strengthening and stabilization of the hip and appropriate analgesic and anti-inflammatory medication.
16170368|NCT01621334|Behavioral|Motivational Enhancement Therapy|Two personal feedback sessions with counselor using motivational interviewing strategies.
16170369|NCT01621334|Behavioral|Educational information|Educational brochure about legal, health and behavioral effects of intimate partner violence, substance abuse, and HIV risky behaviors
16170370|NCT01621321|Drug|Prednisolone|Prednisolone 0.5 mg/kg/day for 4 weeks; 0.25 mg/kg/day for 4 weeks; 0.125 mg/kg/day for 4 weeks. Then taper by 5 mg every 4 weeks and discontinue. Patients will also receive inhaled formoterol/fluticasone (6/125 mcg) 1 puff BD and as needed as per the SMART approach for control of asthma
16170371|NCT01621321|Drug|Voriconazole|Voriconazole 200 mg BD for 4 months. Patients will also receive inhaled formoterol/fluticasone (6/125 mcg) 1 puff BD and as needed as per the SMART approach for control of asthma
16170372|NCT01621308|Other|Mode of insulin administration|There are no interventions in this observational study. Both treatment groups continue the mode of therapy the patient had before the start of the present study: continuous intraperitoneal insulin infusion with an implantable pump (MIP2007D) or subcutaneous insulin administration with multiple daily injections or continuous subcutaneous insulin infusion.
16170373|NCT01621282|Other|Education|A 6-month interactive course on critical appraisal
16170374|NCT01621282|Other|Conventional|Conventional method/no intervention
16170375|NCT01621269|Drug|Fingolimod|
16170376|NCT01621256|Drug|Ancrod|Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections
16170377|NCT01621256|Drug|Saline solution|Day 1: Intravenous infusion; Days 2, 4, and 6: Subcutaneous injections
16170378|NCT01621243|Drug|nab-paclitaxel|nab-paclitaxel dosed on Day 1, Day 8, Day 15 of each 28-day cycle
16170379|NCT01621243|Drug|gemcitabine|gemcitabine will be dosed on Day 1, Day 8, Day 15 of each 28-day cycle
16170380|NCT01621243|Drug|placebo|Placebo will be dosed daily
16170381|NCT01621243|Drug|Necuparanib|Necuparanib will be dosed daily
16170382|NCT01621230|Drug|Epidural Bupivacaine plus fentanyl|The subjects will receive 0.125% bupivacaine with fentanyl 2 mcg/mL at a rate of 10 mL/hr.
16170383|NCT01621230|Drug|Epidural fentanyl|The subjects will receive epidural fentanyl 10 mcg/mL with the rate of 10mL/hr.
16170384|NCT01621217|Drug|Cetuximab|Will be given weekly intravenously during study treatment.
16170385|NCT01621217|Drug|Mitomycin C|Will be given intravenously twice together with 5-Fluoruracil during study treatment.
16170386|NCT01621217|Drug|5-Fluoruracil|Will be given intravenously twice together with Mitomycin C during study treatment
16170387|NCT01621217|Radiation|Radiotherapy|Radiotherapy, once daily with a total dose of 54 Gy, given in 27 fractions.
16170388|NCT01621204|Drug|Eltrombopag|Participants are started on 50mg daily oral pill (or 25mg daily for patients of East Asian descent) 21 days before surgery. Dose may be adjusted based on subsequent platelet counts (minimum 25mg; maximum 75mg).
16170389|NCT01621204|Drug|IVIG infusion|IVIG infusion (1-2 g/kg) given 7 (+/-2) days prior to surgery; with an additional infusion allowed within one week of achievement of surgical hemostasis, if needed
16170394|NCT01621165|Drug|Addition of prazosin to usual care (add-on study)|Prazosin and placebo will be gradually titrated over 10 days to a final dose of 10 mg/day, given in divided doses (three times a day). During this time subjects will be monitored for adverse effects to prazosin and manic symptoms will be monitored. Vital signs will be monitored three times a day throughout the study. If a subject receiving prazosin or placebo develops distressing adverse effects, the dose will be decreased to the next lower dose.If there is a greater than 15 mg mercury postural fall in systolic bBP, dosing will be held at the previous day's dose.Subjects who do not tolerate prazosin or placebo will be discharged from the study.
16170395|NCT01621165|Drug|Placebo|Prazosin and placebo will be gradually titrated over 10 days to a final dose of 10 mg/day, given in divided doses (three times a day). During this time subjects will be monitored for adverse effects to prazosin and manic symptoms will be monitored. Vital signs will be monitored three times a day throughout the study. If a subject receiving prazosin or placebo develops distressing adverse effects, the dose will be decreased to the next lower dose.If there is a greater than 15 mg mercury postural fall in systolic bBP, dosing will be held at the previous day's dose.Subjects who do not tolerate prazosin or placebo will be discharged from the study.
16170396|NCT01621152|Other|Conventional management arm|Based on KDIGO guidelines and as per primary physician in the ICU
16170397|NCT01621152|Other|AKI sniffer instigated AKI management|After identification of patients with AKI by the sniffer, primary physicians will be notified about the development of the syndrome and will be given a copy of the KDIGO guidelines for management of AKI.
16170398|NCT01621139|Procedure|Acupuncture|Patients on mechanical ventilation greater than two days will be randomly assigned to real acupuncture group or sham acupuncture group
16170399|NCT01621126|Device|Intra-operative neuromonitoring (XLTEK/NATUS EP Protektor)|Device: Intra-operative neuromonitoring A XLTEK/NATUS EP Protektor machine (at MGH) or a Cadwell Cascade Elite neuromonitoring machine (at BWH), both FDA approved for intra-operative neuromonitoring, will deliver the electrical stimulus applied transcranially to stimulate the motor cortex, while motor evoked responses will be recorded from different myotomes from both upper limbs. Also the same equipment will deliver electrical stimulus to stimulate peripherally the median and ulnar nerves at the wrists, with recording of the thalamocortical potentials in the scalp channels.
16170400|NCT01621113|Drug|Dalfampridine|Dalfampridine 10 mg tablet, twice-daily, for 10 weeks
16170401|NCT01621113|Drug|Placebo|Placebo tablet, twice daily, for 10 weeks.
16170402|NCT01621100|Drug|OROS hydromorphone|Type= exact number, unit= mg, number= 4, form= tablet, route= oral, administered from 1st evaluation day (Day 1) to 2nd evaluation day (Day 15±2). Dosage adjustment: If NRS (Numeric Rating Scale) =4 or more then dose can be increased by 4mg until the average pain intensity for the past 24 hours is adjusted to lower than NRS 3. For the treatment of breakthrough pain, if necessary the one-time administration dose of quick-effect OROS Hydromorphone shall be 2mg up to the daily dosage of the study medicine, 12mg.
16170403|NCT01621087|Other|Safflower oil|Liquid safflower oil and safflower oil polyunsaturated margarine
16170404|NCT01621074|Dietary Supplement|Sodium bicarbonate|Ergogenic effect
16170405|NCT01621074|Dietary Supplement|Placebo|Placebo effect
16170406|NCT01621022|Drug|bupropion + nicotine gum|150 mg bupropion twice daily plus 4 mg nicotine gum as needed (up to 12 pcs/day)
16170407|NCT01621022|Drug|Active bupropion-Placebo gum|150mg bupropion twice daily plus placebo nicotine gum as needed (up to 12 pcs/day)
16170408|NCT01621022|Drug|Placebo bupropion-Placebo gum|Placebo bupropion twice daily + placebo nicotine gum as needed (up to 12 pcs/day)
16170409|NCT01621009|Drug|Active bupropion + counseling|"Medications-Pre-quit: 150 mg bupropion per day 7 days before quit attempt, then 150 mg twice daily for 4 days before quit attempt; then 150 mg bupropion twice daily for eight weeks.
~Counseling-Pre-quit: two 10 minutes sessions before quit date; eight 10-minute sessions post quit date."
16170410|NCT01621009|Drug|Active bupropion, No counseling|"Medication - 150 mg bupropion per day starting week before quit day, then 150 mg twice daily 3 days before quit day, then 150 mg twice daily for eight weeks after quit day.
~Counseling: No cessation counseling, only medication checks"
16170411|NCT01621009|Drug|Placebo medication + counseling|"Placebo bupropion once daily 7 days before quit day, then twice daily 4 days before quit attempt, then twice daily for 8 weeks after quit day.
~Counseling: Two 10-minutes sessions before quit day, then eight 10-minutes sessions for eight weeks after quit day."
16170412|NCT01621009|Drug|Placebo medication, No counseling|"Pre-quit: Placebo medication once daily 7 days before quit day, then twice daily before quit day, then twice daily for 8 weeks after quit day.
~Counseling: No counseling, just medication checks"
16170413|NCT01620996|Behavioral|Minimal Intervention|There is no clear definition of this term and it has been used by many different groups to refer to attempts to alter behavior by providing very brief, focused interventions. A slightly more developed model guiding intervention is called the 5-A model. This refers to the acronym Ask, Advise, Assess, Assist and Arrange. This model has been endorsed by the US Public Health Department, who has incorporated the 5-A approach into their clinical practice guidelines (A Clinical Practice Guideline for Treating Tobacco Use and Dependence; A US Public Health Service Report. JAMA, June 20, 2000 - Vol 283 No. 24; see also http://www.surgeongeneral.gov/tobacco/tobaqrg.htm).
16170414|NCT01620996|Behavioral|Motivational Interviewing|"Motivational Interviewing has its roots in alcohol abuse counseling and was pioneered by Miller and Rollnick. It is an approach to counseling that is geared toward increasing an individual's motivation, or buy-in, to the work that needs to be done to reduce substance dependence. Miller and Rollnick offer the approach as a brief intervention (hence some confusion with the term minimal intervention) guided by the following mediators of change, which they call ingredients of change, summarized by the Acronym FRAMES:
~FEEDBACK of personal risk or impairment Emphasis on personal RESPONSIBILITY for change Clear ADVICE to change A MENU of alternative change options Therapist EMPATHY Facilitation of client SELF-EFFICACY or optimism
~These mediators/ingredients are delivered by the clinician using the following principles:
~Express Empathy Develop Discrepancy Avoid Argumentation Roll with Resistance Support Self-Efficacy"
16170460|NCT01620632|Procedure|Laparoscopy assisted ERCP|Patients will go the the Operating room and through laparoscopy will have an ERCP for their medical indication.
16170461|NCT01620619|Other|Arthroscopic Bankart Repair alone|Usual arthroscopic Bankart repair
16170462|NCT01620619|Procedure|Closure of rotator interval|Usual arthroscopic Bankart repair plus rotator cuff interval closure
16170652|NCT01619176|Drug|non-steroidal anti-inflammatory drug (NSAID)|NSAID: 100mg twice a day for 3 months
16170415|NCT01620996|Behavioral|Motivational Enhancement|"Motivational enhancement is the most comprehensive term and reflects the integration of two major theorists; Millner and Rollnick on the one hand, and Prochaska and his colleagues on the other. The work of Miller and Rollnick occurred within substance abuse, primarily alcohol abuse and is best summarized in the section above on motivational interviewing. As Prochaska's work, which initially began in the area of smoking cessation but quickly expanded to include wide-ranging health behaviours, developed Miller and Rollnick incorporated his work with theirs.Prochaska's model derives from his long term study of the process of behaviour change regardless of the model of intervention implemented.The model is often referred to as the stages of change model, or readiness to change model.
~The stages of change model identifies five separate stages; precontemplation,contemplation, preparation, action, and maintenance
~These stages are specific to different behaviours."
16170416|NCT01620983|Behavioral|Pain Coping Skills Training|
16170417|NCT01620983|Behavioral|Arthritis Education|
16170418|NCT01620983|Other|Usual Care|
16170419|NCT01620970|Drug|PF03446962|PF-03446962 will be administered in 1hr intravenously at a dose of 10 mg/Kg on day 1, then every 2 weeks until the evidence of disease progression or onset of unacceptable toxicity.
16170420|NCT01620944|Drug|Atazanavir|Capsule, oral, 300 mg, Once daily (QD), 96 weeks
16170421|NCT01620944|Drug|Ritonavir|Tablets, oral, 100 mg, QD, 96 Weeks
16170422|NCT01620944|Drug|Lamivudine|Tablet, oral, 300 mg, QD, 96 Weeks
16170423|NCT01620944|Drug|Tenofovir/Emtricitabine|Tablets, oral, 300/200 mg, QD, 48 Weeks
16170424|NCT01620931|Drug|RO5469754|Single ascending doses, iv or sc
16170425|NCT01620931|Drug|Placebo|Single doses, iv or sc
16170426|NCT01620918|Procedure|normal healing abutment|Patient receives the normal, uncoated healing abutment on 1 of his (minimal 2) dental implants.
16170427|NCT01620918|Procedure|nano-structured healing abutment|Patient receives the nano-structured healing abutment on 1 of his (minimal 2) dental implants.
16170428|NCT01620905|Procedure|Manipulation|Single level cervical spine joint manipulation
16170429|NCT01620866|Other|Eye Movement Desensitization Reprocessing (EMDR)|EMDR is an effective treatment in PTSD but has never been tested in bipolar traumatized patients.
16170430|NCT01620840|Drug|Lacosamide 10mg/ml|intravenous administration up to 10 days
16170431|NCT01620827|Other|Hospital Landline Phone Calls|Follow-up phone calls are made from the hospital landline phones in a research office
16170432|NCT01620827|Other|Private Cell Phone Calls|Follow-up phone calls are made from the private cell phones of research assistants
16170433|NCT01620814|Drug|Dinoprostone|
16170434|NCT01620814|Drug|misoprostol|
16170435|NCT01620814|Drug|control|
16170436|NCT01620801|Biological|AAV8-hFIX19|One-time IV vector administration.
16170437|NCT01620788|Drug|Indapamide / Losartan|1 tablet of Indapamide 1.5mg + Losartan 50mg, oral, a day
16170438|NCT01620788|Drug|Indapamide / Losartan|1 tablet of Indapamide 1.5mg + Losartan 100mg, oral, a day
16170439|NCT01620788|Drug|Hyzaar®|1 tablet of Hyzaar®, oral, a day
16170440|NCT01620788|Drug|Hyzaar®|1 tablet of Hyzaar®, oral, a day
16170441|NCT01620775|Other|MRIs|Subjects will have an MRI scan to view specific images, and brain activity patterns thought to be affected in patients with KOA, chronic low back pain and diabetic patients with painful neuropathy. Healthy volunteers will undergo the same MRI scan that lasts about 90 min.
16170442|NCT01620775|Other|Pain testing|There will be a 1-1.5 hour session including pain tolerance testing.
16170443|NCT01620762|Drug|Cat-PAD|1 dose every 4 weeks
16170444|NCT01620762|Drug|Placebo|1 dose every 4 weeks
16170445|NCT01620749|Radiation|18F MEL050|Diagnostic intervention to establish the safety and biodistribution of MEL050 in participants with melanoma.
16170446|NCT01620736|Drug|Raltegravir|Raltegravir 400 mg po bid
16170447|NCT01620723|Other|New Breastfeeding Counselling|An intervention will be developed during the first part of the study. The intervention is supposed to consist of evidence based actions to support the metabolic adaptation of the newborn, establishment of the milk production of the mother and increase the breastfeeding self efficacy of the mother.
16170448|NCT01620723|Other|Treatment as usual|Health professionals offer the usual care for the breastfeeding mother
16170449|NCT01620710|Radiation|hypofractionated helical IMRT|hypofractionated helical IMRT of the prostate bed, 18 x 3 Gy
16170450|NCT01620710|Radiation|hypofractionated helical IMRT|helical IMRT of the prostate bed (18 x 3 Gy) and the pelvic lymph nodes (18 x 2.5 Gy)
16170451|NCT01620697|Procedure|Colorectal surgery|Colorectal surgery
16170452|NCT01620684|Drug|metyrapone|Overnight treatment (15 mg/kg at midnight and 15 mg/kg at 6 am)
16170453|NCT01620684|Drug|placebo|placebo capsules
16170454|NCT01620671|Procedure|Surgical repair of perforated peptic ulcer|Perforated peptic ulcer located in the stomach and the duodenum will be repaired by either primary repair or omentoplasty.
16170455|NCT01620671|Procedure|Surgical repair of perforated peptic ulcer|Perforated peptic ulcer located in the stomach and the duodenum will be repaired by either primary repair or omentoplasty.
16170459|NCT01620645|Radiation|CT scan and PA chest X-ray|"All participants will receive a single high resolution CT scan of the chest. This will be performed using a low tube current, helical technique. Participants may also receive a plain chest X-ray if clinically indicated.
~The total research protocol dose is 2 mSv. The dose from the chest X-ray is insignificant compared with the dose from the CT scan of the chest, therefore all this dose can be considered to be additional to standard of care. A dose of 2 mSv represents a risk of radiation induced detriment of approximately 1 in 10,000 and is equivalent to about 11 months of average natural background radiation in the UK."
16170463|NCT01620606|Behavioral|Cognitive Behavioral Therapy & Social Learning|Cognitive Behavioral Therapy & Social Learning
16170464|NCT01620606|Behavioral|Education and Support|Education about the GI system, nutrition and food safety
16170465|NCT01620593|Drug|Placebo|All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient 500mg tablets of placebo after castration, blinded to the patient and the study team.
16170466|NCT01620593|Drug|Metformin|All eligible subjects will be randomized in a 1:l manner to receive a bottle containing sufficient 500mg tablets of metformin after castration, blinded to the patient and the study team.
16170467|NCT01620580|Behavioral|Self-management|"Participants in the intervention group will receive printed self management strategies each of the 5 symptoms, a symptom diary with the self-management strategies and a 15 minutes discussion. The intervention script will instruct participants on how to use the printed strategies by PI and RA #1.
~Week 3"
16170468|NCT01620580|Behavioral|Dietary Information|The control or usual care group will receive a symptom diary designed for the control group without any strategies and a 5 minutes discussion on how to complete the diary from RA# 1. The PI will make weekly follow up calls on the same schedule as the intervention group starting week 4 until week 7 for a total of 4 calls focusing on enhancing healthy eating skills & adherence to renal diet and fluid restriction without discussing any intervention with the group.
16170469|NCT01620567|Other|avocado|1 avocado/day for 6 months
16170470|NCT01620567|Other|potato or chickpea|1 cup potatoes or chickpeas/day for 6 months
16170471|NCT01620554|Drug|BF2.649|1 capsule per week during 2 weeks
16170472|NCT01620554|Drug|BF2.649|1 capsule per week during 2 weeks
16170473|NCT01620554|Drug|BF2.649|1 capsule per week during 2 weeks
16170474|NCT01620554|Drug|BF2.649|1 capsule per week during 2 weeks
16170475|NCT01620554|Drug|Placebo|1 capsule per week during 2 weeks
16170476|NCT01620541|Procedure|Ankle Arthrodesis|All surgeons will employ a well-established technique of rigid internal fixation. In this technique, the joint is prepared by removing cartilage from the surfaces, the bones are positioned as desired, and screws and/or a plate are attached to compress the bones together and prevent motion. This technique obviates the need for a cast or external support. Patients are allowed to walk with weight bearing aids immediately. Radiographs are performed at 6 weeks to determine weight bearing status. Weight is allowed on the limb in increments over the 6 to 12 weeks after surgery.
16170477|NCT01620541|Procedure|Ankle Arthroplasty|Protocols are similar among participating centers. Each surgeon uses an anterior surgical approach between the tibialis anterior tendon and the toe extensor group, splints the ankles for 2 weeks, and restricts weight bearing for the first 6 weeks. Radiographs are performed at 6 weeks to determine weight bearing status. The study involves only FDA approved implants with which the surgeon has established experience.
16170478|NCT01620528|Drug|elagolix|oral tablet
16170479|NCT01620528|Other|placebo|oral tablet
16170480|NCT01620515|Drug|NX-1207 2.5 mg|A single intraprostatic injection of NX-1207 2.5 mg followed by active surveillance.
16170481|NCT01620515|Drug|NX-1207 15 mg|A single intraprostatic injection of NX-1207 15 mg followed by active surveillance.
16170482|NCT01620502|Dietary Supplement|Omega-3 fatty acids|A daily treatment of 5 identical capsules of EPA (3.5 g/d), DHA (1.75 g/d) or placebo (high oleic oil), in single or divided administration for 2 (Study 1) or 8 weeks (Study 2)
16170483|NCT01620489|Drug|liraglutide|1.8 mg administered once daily subcutaneously (s.c., under the skin) as add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen.
16170484|NCT01620489|Drug|placebo|Administered once daily subcutaneously (s.c., under the skin) as add-on to the subject's stable pre-trial oral antidiabetic drug (OAD) and/or insulin regimen.
16170485|NCT01620476|Drug|liraglutide|5 mcg/kg for 21 days. Injected subcutaneously once daily. Progression to the next dose level based on safety data
16170486|NCT01620476|Drug|liraglutide|5 mcg/kg for 7 days followed by 10 mcg/kg for 14 days. Injected subcutaneously once daily. Progression to the next dose level based on safety data
16170487|NCT01620476|Drug|liraglutide|5 mcg/kg for 7 days followed by 10 mcg/kg for 7 days followed by 15 mcg/kg for 7 days. Injected subcutaneously once daily
16170488|NCT01620476|Drug|placebo|Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1
16170489|NCT01620463|Drug|liraglutide|Single dose administered subcutaneously at four different dose levels: 2.5, 5.0, 10.0 and 15.0 mcg/kg. Following completion of each dose group, an evaluation will be performed to allow progression to the next dose group
16170490|NCT01620463|Drug|placebo|Single dose administered subcutaneously at four different dose levels: 2.5, 5.0, 10.0 and 15.0 mcg/kg. Following completion of each dose group, an evaluation will be performed to allow progression to the next dose group
16170491|NCT01620450|Drug|biphasic human insulin 30|Single dose of each formulation administered subcutaneously (s.c., under the skin) on two separate visits
16170492|NCT01620437|Drug|biphasic insulin aspart 50|A single dose administrated subcutaneously (s.c., under the skin) on two separate dosing visits. A wash-out period of 6-21 days will take place between dosing visits
16170493|NCT01620424|Drug|biphasic insulin aspart 30|Single dose administered subcutaneously (s.c., under the skin) on two dosing vists. A wash-out period of 2-28 days will take place between dosing visits
16170494|NCT01620424|Drug|biphasic insulin aspart 50|Single dose administered subcutaneously (s.c., under the skin) on two dosing vists. A wash-out period of 2-28 days will take place between dosing visits
16170495|NCT01620411|Other|Comprehensive Medical Management|Standard of care for failed back surgery syndrome sustained while on active duty, primarily focused on physical therapy, medication including: opioid analgesics, muscle relaxants, non-opioid analgesics, etc.
16170496|NCT01620411|Procedure|Spinal Cord Stimulator|This arm combines comprehensive medical management (as above) with the trial and possible eventual permenant placement of a spinal cord stimulator, a common pain management procedure.
16170497|NCT01620398|Behavioral|BALANCE|
16170498|NCT01620398|Behavioral|Control diet|Participants will be encourage to follow a generalized diet counseling prepared by dietitians based on low fat, low energy, low sodium and low cholesterol diets. They will receive a common folder composed by lists of foods that should be preferred or avoided. For example, avoidance of ultra processed foods, preference for boiled and baked foods rather than fried foods and recommendation of having at least five meals a day. This folder is equivalent of several that are given on ambulatories or hospital of Brazilian public health.
16170653|NCT01619176|Drug|leflunomide|leflunomide: 20mg/day for 3 months
16170499|NCT01620385|Device|ciPDA|The ciPDA Research Platform device was designed as a research tool for cochlear implant research.
16170500|NCT01620359|Device|ExAblate MRgFUS|100% ablation of an up-to-2-cm breast cancer visible on an contrast-enhanced MRI with 5-10 mm margins around the primary tumor
16170501|NCT01620346|Procedure|Intracytoplasmic sperm injection (ICSI)|ICSI is routinely used to treat couples with infertility. Sperm selection in the ICSI group was analysed under a magnification of 400x using an inverted microscope. ICSI was performed in a micro-injection dish prepared with 4 µL droplets of buffered medium (Global® w/HEPES, LifeGlobal, Connecticut, USA) and covered with paraffin oil on a heated stage at 37.0 ± 0.5°C of an inverted microscope.
16170502|NCT01620346|Procedure|Intracytoplasmic morphologically selected sperm injection|IMSI is an established modified ICSI procedure that used an unstained real-time observation of spermatozoa under high-magnification. Sperm selection in the IMSI group is examined at high magnification using an inverted microscope equipped with high-power differential interference contrast optics (DIC/Nomarski). The total calculated magnification is x6.600. The sperm cells exhibiting normally shaped nuclei and normal nuclear chromatin content are selected for injection.
16170503|NCT01620333|Drug|biphasic insulin aspart 50|A single dose of 0.08 U/kg body weight, administered subcutaneously (s.c., under the skin) on two dosing visits in random order separated by 6-12 days
16170504|NCT01620333|Drug|biphasic insulin aspart 70|A single dose of 0.08 U/kg body weight, administered subcutaneously (s.c., under the skin) on two dosing visits in random order separated by 6-12 days
16170505|NCT01620320|Other|Stress echocardiography|Patients able to exercise will have a treadmill test + echography; the others will have a dobutamine echography.
16170506|NCT01620307|Drug|Sirolimus (Rapamune 2mg/day, Pfizer)|Sirolimus (Rapamune 2mg/day, Pfizer) or not for a course of 14 days.
16170507|NCT01620294|Procedure|abdominal wall closure|triclosan-coated (PDS-Plus) and non-coated (PDS) suture to close the abd. wall
16170508|NCT01620294|Procedure|surgical site infection|triclosan-coated (PDS-Plus) and non-coated (PDS) suture to close the abd. wall
16170509|NCT01620281|Device|no!no!Back|Self treatments daily for 3 weeks, in up to three 10-minutes sessions
16170510|NCT01620268|Drug|Leflunomide and orotic acid|Daily dose of leflunomide adjusted to target steady state blood levels of 50 ug/mL to 100 ug/mL of the active metabolite plus 600 mg orotic acid
16170511|NCT01620255|Drug|Placebo|Placebo delivered subcutaneous injection, 3 doses separated by 4 weeks
16170512|NCT01620255|Drug|PF-00547659 SC Injection|Drug Dose Level 1 delivered subcutaneous injection, 3 doses separated by 4 weeks
16170513|NCT01620255|Drug|PF-00547659 SC Injection|Drug Dose Level 2 delivered subcutaneous injection, 3 doses separated by 4 weeks
16170514|NCT01620255|Drug|PF-00547659 SC Injection|Drug Dose Level 3 delivered subcutaneous injection, 3 doses separated by 4 weeks
16170515|NCT01620255|Drug|PF-00547659 SC Injection|Drug Dose Level 4 delivered subcutaneous injection, 3 doses separated by 4 weeks
16170516|NCT01620242|Drug|Cabazitaxel|25 mg/m2 every 3 weeks by IV administration
16170517|NCT01620229|Drug|brentuximab vedotin|Given IV
16170518|NCT01620229|Other|laboratory biomarker analysis|Correlative studies
16170519|NCT01620229|Other|pharmacological study|Correlative studies
16170520|NCT01620216|Other|Antitumor Drug Screening Assay|Undergo pre clinical kinase inhibitor activity screening
16170521|NCT01620216|Drug|Dasatinib|Given PO
16170522|NCT01620216|Drug|Idelalisib|Given PO
16170523|NCT01620216|Other|Laboratory Biomarker Analysis|Correlative studies
16170524|NCT01620216|Drug|Pacritinib|Given PO
16170525|NCT01620216|Other|Pharmacological Study|Correlative studies
16170526|NCT01620216|Drug|Ponatinib|Given PO
16170527|NCT01620216|Drug|Ponatinib Hydrochloride|Given PO
16170528|NCT01620216|Drug|Ruxolitinib|Given PO
16170529|NCT01620216|Drug|Sorafenib|Given PO
16170530|NCT01620216|Drug|Sorafenib Tosylate|Given PO
16170531|NCT01620216|Drug|Sunitinib|Given PO
16170532|NCT01620216|Drug|Sunitinib Malate|Given PO
16170533|NCT01620203|Other|No intervention/treatment is given|
16170534|NCT01620190|Other|Laboratory Biomarker Analysis|Correlative studies
16170535|NCT01620190|Drug|Paclitaxel Albumin-Stabilized Nanoparticle Formulation|Given IV
16170536|NCT01620177|Drug|Alcohol(oral) and placebo|Subjects will be dosed to an approximate peak BAC of 0.065%. Subjects will be tested on the decline such that subjects will be at or above the goal BAC (0.05%) throughout the drive
16170537|NCT01620177|Drug|Cannabis(THC)(Inhaled) and Placebo|Cannabis vapor is produced from 500 mg either placebo (0% THC), approximately 2.5-3.5% THC (low dose), or approximately 6.0-7.5% THC (high dose) bulk cannabis plant material to yield doses of approximately 0, 12.5-17.5, or 30-37.5 mg THC
16170538|NCT01620164|Other|Psychophysical measurements of 3D perception|3D psychophysical performances using a categorization tasks and their underlying mechanisms measured with visual evoked potentials will be assessed in a randomized and comparative study. The order of psychophysical and visual evoked potentials experiments will be randomized between the L Dopa ON and OFF conditions. The randomization will be done by the clinical investigational center. The comparisons will be made between parkinsonian patient and control subjects, and between parkinsonian patients in L Dopa ON and OFF conditions.
16170539|NCT01620151|Procedure|Extended neck with standard support or pillow|Patient will undergo thyroid surgery with an extended neck
16170540|NCT01620138|Drug|Pasireotide|"The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at the dosage of 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for six months.
~The patients with resistant prolactinomas will be treated with pasireotide at the dosage of 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
16170541|NCT01620138|Drug|cabergoline|"The patients with NFPA will be randomized into two groups: (A) the first one will be treated with pasireotide at 900 µg s.c. twice a day for 6 months; (B) the second one, with cabergoline 3 mg/week for 6 months.
~The patients with resistant prolactinomas will be treated with pasireotide at 600 µg s.c. twice a day. After four weeks of treatment, the patients who normalize serum prolactin level will be maintained at the same dosage, the others who do not achieve normal prolactin level will have their dosage raised to 900 µg s.c. twice a day for six months."
16170542|NCT01620125|Dietary Supplement|Lactobacillus reuteri DSM 17938|Ordinary treatment against type 2 diabetes is supplemented with one tablet containing 100 million Lactobacillus reuteri DSM 17398, once daily for 12 weeks
16170543|NCT01620112|Drug|high Clonidine concentration|Clonidine 1 ml - 150 mcg on 20 ml de lidocaine 1,5% on axillary brachial plexus block for upper limb surgery
16170544|NCT01620112|Drug|low clonidine concentration|Clonidine 1 ml - 150 mcg on 40 ml of lidocaine 1,5% - single injection on axillary brachial plexus block for upper limb
16170545|NCT01620112|Drug|Lidocaine|Lidocaine 1,5% 20 ml 300 mg for single injection on axillary brachial plexus block for upper lim surgery
16170546|NCT01620112|Drug|Lidocaine 40 ml|Lidocaine 40 ml 1,5% 600 mg single injection for axillary brachial plexus block for upper limb surgery
16170547|NCT01620099|Drug|Extrafine treatment (Clenilexx(R) or Foster(R))|Following the initial evaluation (cross-sectional) patients will be switched to an extrafine equipotent dose of the same compound (extrafine beclomethasone dipropionate - Clenilexx(R) - if the patient was on ICS) or combination (extrafine beclomethasone dipropionate/formoterol - Foster(R) - if the patient was on ICS/LABA combination). After 3-months patients will be reassessed for lung function and asthma control
16170548|NCT01620086|Device|Active Repetitive Transcranial Magnetic Stimulation 1 Hz|active rTMS delivered at 1Hz frequency over temporal cortex
16170549|NCT01620086|Device|Active Repetitive Transcranial Magnetic Stimulation 10 Hz|active rTMS delivered at 10 Hz frequency over temporal cortex
16170550|NCT01620086|Device|Active control site Repetitive Transcranial Magnetic Stimulation at 1Hz|active rTMS delivered at either 1 Hz frequency over the vertex
16170551|NCT01620086|Device|Sham control site Repetitive Transcranial Magnetic Stimulation|sham rTMS delivered at 1Hz frequency over the vertex
16170552|NCT01620086|Device|Active control site Repetitive Transcranial Magnetic Stimulation at 10 Hz|Active 10 Hz rTMS delivered over the vertex
16170553|NCT01620073|Other|HIV counseling and testing|Male partner HIV counseling and testing
16170554|NCT01620060|Drug|Lurasidone|Lurasidone 20, 40,80, 120 or 160 mg/day oral single and multiple does of lurasidone for 12 days
16170555|NCT01620047|Drug|Fentanyl|Fentanyl 3 µg/ml continuously infused for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU)through a femoral nerve sheath catheter.
16170556|NCT01620047|Drug|Ropivacaine|Ropivacaine 0.1% delivered through a femoral nerve sheath catheter continuously for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
16170557|NCT01620047|Drug|Fentanyl|0.9% normal saline delivered through a femoral nerve sheath catheter in addition to a continuous intravenous infusion of fentanyl 3 µg/ml via a PCA pump for a 24 hour period at a basal rate of 10ml/hour starting from the time the patient entered the post anesthesia care unit (PACU).
16170558|NCT01620034|Radiation|Stereotactic Body Radiotherapy|Patients on the 11 day arm receive 4 fractions of SBRT every 3rd day. Patients on the 4 day arm receive 4 fractions of SBRT every day.
16170559|NCT01620008|Procedure|Delayed Cord Clamping|At birth, the infant will be placed on the maternal abdomen and the umbilical will either be cut immediately or after a 5 minute delay.
16170560|NCT01619982|Drug|Cefazolin 25 mg/kg body weight and Vancomycin hydrochloride|Cefazolin 25 mg/kg/dose administered intravenously over 5 minutes within 60 minutes of surgical incision and then re-dosed (25 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery and Vancomycin 15 mg/kg (max 1.5 gram/dose) will be administered intravenously over 1-2 hours (after completion of cefazolin infusion) For patients younger than 1 month of age, a one-time repeat dose of 15 mg/kg can be given intraoperatively 12 hours after the beginning of the first vancomycin dose if the procedure is > 12 hours in duration. For patients equal to or older than 1 month, a one-time repeat dose of 15 mg/kg (max 1.5 grams) will be given intra-operatively 8 hours after the beginning of the first vancomycin dose if the procedure is > 8 hours in duration.
16170561|NCT01619982|Drug|Cefazolin 30 mg/kg body weight|"Intervention: Drug: Cefazolin pre-operative prophylaxis
~Other Names:
~Cefazolin: Brand Names Ancef, Kefzol
~Cefazolin 30 mg/kg/dose administered intravenously over 10 minutes within 60 minutes of surgical incision and then re-dosed (30 mg/kg: maximum 2 grams/dose) every 4 hours intra-operatively depending on the duration of surgery as per standard peri-operative prophylaxis for cardiac surgery."
16170562|NCT01619969|Drug|celgosivir|100 mg capsules, 400 mg loading dose 200 mg bid
16170563|NCT01619969|Drug|placebo|Capsules of identical appearance containing starch
16170564|NCT01619956|Device|SLA dental implants|Dental implant with surface modification.
16170565|NCT01619956|Procedure|Osteotome sinus floor elevation|"After locating the implant position by a round bur, the pilot drilling was performed to the depth approximately 1-2 mm away from the sinus floor boundary according to the depth taken from the pre-surgical radiograph. The cortical part of the implant bed was further widened to either 3.5mm for 4.1mm implants or 4.2mm for 4.8mm implants. Then the elevation of the maxillary sinus was achieved and developed using osteotome (Straumann Osteotome Kit, Straumann AG, Waldenburg, Switzerland) by light malleting to create a greenstick fracture on the compact bone of sinus floor and to increase diameters gradually till the final depth. The sinus membrane was tested again for any perforation by Valsalva manoeuvre."
16170566|NCT01619956|Procedure|Bone grafting|the autogenous bone chips harvested during the drilling procedure was mixed up with Bio-Oss® in approximately 1: 4 ratio. And the mixture was placed into the 'socket' by osteotomes when elevating the sinus membrane until the final depth.
16170567|NCT01619943|Other|no intervention|clinical follow up
16170568|NCT01619943|Other|no intervention|no intervention
16170569|NCT01619930|Behavioral|Physical activity without motivational interviewing|Focus is on physical exercise, motivated by research findings that it has a positive effect on depressive symptoms. An individualized exercise program is constructed, to be followed by the respective participant. A user-friendly pulse watch will be mailed to participants. Exercise is monitored through online self-registration with automated feedback.
16170610|NCT01619644|Drug|sodium valproate|sodium valproate (HDAC inhibitor) with an oral dosage of 30 mg/kg/jour
16170611|NCT01619644|Drug|Placebo|Placebo with an oral dosage of 30 mg/kg/jour
16170650|NCT01619189|Procedure|transplantation of cultured cells|transplantation of allogeneic or autologous limbal epithelial stem cells cultured on human amniotic membrane with no feeders
16170651|NCT01619176|Drug|methotrexate|methotrexate: 7.5mg/week to 15mg/week for 3 months
16170570|NCT01619930|Behavioral|Physical exercise with motivational interviewing|Focus is on physical exercise, motivated by research findings that it has a positive effect on depressive symptoms. An individualized exercise program is constructed, to be followed by the respective participant. A user-friendly pulse watch will be mailed to participants. Exercise is monitored through online self-registration with automated feedback. An initial motivational interview (MI) per telephone is also conducted, to explore the intrinsic motivation to change in participants.
16170571|NCT01619930|Behavioral|Behavioral activation with rationale|A behavioral activation program, based on the TRAP-TRAC model according to which suffering individuals are trapped in a vicious circle of avoidance and ever fewer reinforcers, leading to increasing discomfort. To break free of this vicious circle, patients have to replace avoidance patterns with alternative coping strategies. Unlike previous applications of this program done in the U.S., this study will feature an internet-based administration. Approximately 15 minutes of electronic therapist support will be included per week.
16170572|NCT01619930|Behavioral|Behavioral activation without rationale|"A behavioral activation program without TRAP-TRAC rationale, but with some encouragement provided (Activate yourself and feel better!). Approximately 15 minutes of electronic therapist support will be included per week."
16170573|NCT01619917|Device|Fractional Vascular Laser|laser energy will be applied to one of 2 sites (proximal or distal) depending on randomization result
16170574|NCT01619904|Procedure|Goal-Directed Therapy|Peri-operative optimisation of fluid status, based on Oxygen Delivery
16170575|NCT01619904|Procedure|Standard Therapy|Following standard protocol during peri-operative period
16170576|NCT01619891|Dietary Supplement|Vitamin D|100mcg per day
16170577|NCT01619878|Drug|Artemether-lumefantrine (COA566)|One dispersible tablet taken orally twice a day during 3 days.
16170578|NCT01619865|Drug|68Ga-DOTATOC PET/CT|1 -5 mCi 68Ga-DOTATOC (10-50 ugm DOTATOC)administered once via IV.
16170579|NCT01619852|Drug|.9 normal saline placebo|Administration of .9 normal saline placebo as a bolus and as maintenance throughout the length of the surgical procedure.
16170580|NCT01619852|Drug|Group L (lidocaine)|Group L will receive a 1.5 mg/kg bolus of intravenous lidocaine followed by a 2mg/kg/hr infusion that will be started at the time of surgical induction and will be discontinued one hour after the end of the surgical procedure.
16170581|NCT01619839|Drug|NKTR-181|
16170582|NCT01619839|Drug|Placebo|Placebo dosing will be only in the double-blind randomization arm and will be identical in form to the Experimental NKTR-181
16170583|NCT01619826|Behavioral|Physical Activity|9-month afterschool program designed to increase physical activity and aerobic fitness.
16170584|NCT01619826|Behavioral|Physical Activity|Participants in this group partake in their regular afterschool activities, without intervention from the study staff.
16170585|NCT01619813|Drug|Docetaxel, Reolysin and Prednisone|Docetaxel 75 mg/m2 will be delivered as a 1-hour infusion q 3 weekly beginning on day 1, cycle 1. Reolysin will be delivered as a 1-hour infusion days 1-5. On day 1 of each cycle, when both agents are given, the docetaxel will be given first. Prednisone 5 mg BID will be given beginning day 1. Each cycle is 3 weeks in length.
16170586|NCT01619813|Drug|Docetaxel and Prednisone|Docetaxel 75 mg/m2 will be delivered as a 1-hour infusion q 3 weekly. Prednisone 5mg BID will be given beginning Day 1. Each cycle is 3 weeks in length.
16170587|NCT01619800|Device|Blended Sensor Optimization (BSO)|"At wound check (POD#1 and 1 Week F/U), histograms from device interrogation obtained from patients in the BSO group are assessed, and these patients undergo optimization. A hall walk and stair climbing exercise will be performed and MV optimized using trending data to hit the following targets:
~HR at Rest: 60 HR upon slow walking: 100 HR upon brisk walking: 115-120 HR upon climbing stairs: 130-135 Patients will undergo optimization, and be instructed that their device may have been optimized."
16170588|NCT01619800|Device|Accelerometer Alone (AA)|Patients in the AA group will also undergo device interrogation, and will perform a hall walk and stair climbing exercise. Afterwards, these patients will undergo a sham optimization by placing the PPM interrogation laptop device over there pacemaker, and instructing the patients that their device may have been optimized.
16170589|NCT01619774|Drug|GSK2118436|Starting dose 150 mg by mouth twice a day.
16170590|NCT01619774|Drug|GSK1120212|2 mg by mouth daily.
16170591|NCT01619761|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic umbilical cord blood transplant
16170592|NCT01619761|Drug|Cyclophosphamide|Given IV
16170593|NCT01619761|Drug|Fludarabine Phosphate|Given IV
16170594|NCT01619761|Other|Laboratory Biomarker Analysis|Correlative studies
16170595|NCT01619761|Drug|Lenalidomide|Given PO
16170596|NCT01619761|Drug|Melphalan|Given IV
16170597|NCT01619761|Drug|Mycophenolate Mofetil|Given IV or PO
16170598|NCT01619761|Biological|Natural Killer Cell Therapy|Given IV
16170599|NCT01619761|Biological|Rituximab|Given IV
16170600|NCT01619761|Drug|Tacrolimus|Given IV or PO
16170601|NCT01619761|Radiation|Total-Body Irradiation|Undergo TBI
16170602|NCT01619761|Procedure|Umbilical Cord Blood Transplantation|Undergo allogeneic umbilical cord blood transplant
16170603|NCT01619709|Other|Pet AV-45|AV-45 (Florbetapir F 18) : Bolus of 5 MBq/kg IV ; A 10-minutes Pet scan acquisition Starts at 50 minutes after injection.
16170604|NCT01619696|Procedure|Pelvic MRI and F MISO TEP|Pelvic MRI and F MISO TEP: before inclusion, 2 weeks after beginning and 7 weeks after completion of chemoradiotherapy.
16170605|NCT01619683|Drug|enclomiphene citrate|12.5 mg, 1 capsule, daily, oral. After 6 weeks of treatment, subjects will remain on 12.5 mg/day if their morning testosterone level is greater than 300 ng/dL. If a subject's testosterone is less than 300 ng/dL, the subject's dose will be increased to 25 mg/day
16170606|NCT01619683|Drug|Placebo|1 placebo capsule per day, oral
16170607|NCT01619670|Device|Apligraf|non adhesive layer
16170608|NCT01619657|Drug|6% Hypertonic Saline (HS), 4mL|Administered via inhalation twice daily for 52 weeks. The delivery system is a PARI LC SPRINT® Junior nebulizer with a baby bend, size-adapted PARI® Baby face mask size 0-3, connection tubing (2.2m) and a PARI JuniorBOY® SX compressor.
16170609|NCT01619657|Drug|0.9% Isotonic Saline (IS), 4mL|Administered via inhalation twice daily for 52 weeks. The delivery system is a PARI LC SPRINT® Junior nebulizer with a baby bend, size-adapted PARI® Baby face mask size 0-3, connection tubing (2.2m) and a PARI JuniorBOY® SX compressor.
16170969|NCT01616485|Drug|Nitrostat|glyceryl trinitrate tablet, USP 0.4 mg
16170612|NCT01619631|Behavioral|12-week Tai Chi intervention|Tai Chi classes will be conducted weekly for one hour each for 12 weeks. Classes will begin with warm-up exercises designed to loosen the body, increase awareness of alignment and structural integration, improve efficiency of breathing, incorporate mindfulness and imagery into movement.
16170613|NCT01619631|Behavioral|Education control group|The education control group will meet twice weekly for 12 weeks for one hour, and research staff will present didactic information modified from psychoeducation curriculums created by the Benson Henry Institute and a stress reduction study for depressed minority patients.
16170614|NCT01619618|Genetic|mutation analysis|
16170615|NCT01619618|Genetic|polymerase chain reaction|
16170616|NCT01619618|Genetic|polymorphism analysis|
16170617|NCT01619618|Other|laboratory biomarker analysis|
16170618|NCT01619605|Procedure|shrimp challenge|Patients with history of shrimp allergy and positive skin tests to shrimp were recruited for shrimp challenges After shrimp challenges, patients with anaphylaxis defined as anaphylaxis group, patients with mild reactions defined as mild reaction group, and patients without symptom defined as control group
16170619|NCT01619592|Device|webbased education (telemonitoring)|"Patients will be able to transmit their blood glucose values via the Internet to the diabetes professional and they will receive timely feedback. Timely will be defined as 'as agreed between the patient and the diabetes professional', e.g. every week on Friday afternoon."
16170620|NCT01619579|Device|AVACEN Thermal Exchange System|Non-invasive device forms vacuum around subject's hand, enabling efficient core body temperature adjustment using heating element inside device.
16170621|NCT01619566|Drug|Duloxetine|oral tablet, 30mg daily for 1 week (titration up) oral tablet, 60mg daily for 8 weeks (treatment) oral tablet, 30mg daily for 1 week (titration down, if needed)
16170622|NCT01619540|Other|Valsalva maneuver|
16170623|NCT01619527|Drug|darunavir|Type=exact number, unit=mg, number=400, form=tablet, route=oral. Two tablets as a single dose or a tablet in combination with cobicistat
16170624|NCT01619527|Drug|cobicistat|Type=exact number, unit=mg, number=150, form=tablet, route=oral. One tablet as a single dose or a tablet in combination with darunavir
16170625|NCT01619488|Device|Adjustable Gastric Band|"Surgical placement of an adjustable gastric band around the upper portion of the stomach.
~Adjustments are made to the band through a subcutaneous port as needed to maintain appropriate restriction."
16170626|NCT01619462|Biological|Prevenar 13 and Synflorix|260 children will be randomized to receive either Prevenar 13 or Synflorix at 1-2-3 months. At 9 months 65 children in the Prevenar 13 arm and 65 children in the Synflorix arm will receive booster dose of Pneumovax and at 23 months all children will receive a micro dose of Pneumovax.Blood will be collected at 1, 4, 9, 10, 23 and 24 months to determine serotype-specific antibody responses. Nasopharyngeal swabs will also be collected to measure carriage of pneumococci and non-typeable Haemophilus influenzae.
16170627|NCT01619449|Procedure|Renal replacement therapy|Liver transplant recipients receiving continuous renal replacement therapy for duration of liver transplant surgery.
16170628|NCT01619436|Drug|Clonidine|bolus, clonidine 2 mg/kg IV
16170629|NCT01619436|Drug|Ringer lactato|1 ML ringer lactato IV, as placebo
16170630|NCT01619423|Drug|PledOx (2 µmol/kg)|PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles.
16170631|NCT01619423|Drug|PledOx (5 µmol/kg)|PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles
16170632|NCT01619423|Drug|PledOx (10 µmol/kg)|PledOx is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles
16170633|NCT01619423|Drug|Placebo (0,9% NaCl)|Placebo (0,9% NaCl) is administered intravenously for up to 5 minutes, about 10 min prior to start of FOLFOX6 chemotherapy which will be administered day 1 and 2 every second week for up to 8 cycles.
16170634|NCT01619410|Biological|Linezolid|Linezolid 600 mg every 12 hours for 7 days
16170635|NCT01619410|Biological|Clindamycin|Clindamycin 300 mg po every 6 hours for 7 days
16170636|NCT01619397|Device|Test condom with new Xanthan gum condom coating|
16170637|NCT01619384|Behavioral|Mindfulness-Based Stress Reduction|An 8-week validated stress reduction program, designed to teach mindfulness.
16170638|NCT01619371|Device|Simplisse Double Electric Breast Pump|Use of breast pump for 10 minutes.
16170639|NCT01619345|Drug|semaglutide|Subjects will be treated with two single doses of 10 mg semaglutide in a tablet. Dosing will be done on 2 dosing visits separated by 4 to 6 weeks.
16170640|NCT01619332|Drug|Placebo|Placebo will be given orally once daily for 28 days to patients assigned to placebo in a randomized and blinded manner
16170641|NCT01619332|Drug|Sitagliptin|Sitaglitpin will be given orally once daily for 28 days to patients assigned to this treatment in a randomized and blinded manner
16170642|NCT01619332|Drug|LEZ763|LEZ763 will be given orally once daily for 28 days in a randomized and blinded manner
16170643|NCT01619319|Other|Cognitive Remediation Therapy|auditory computer games designed to improve the speed at which people react when they hear something and at which they process that information.
16170644|NCT01619319|Other|computer games|computer games that that consist of word puzzles
16170645|NCT01619280|Drug|Sodium Nitroprusside|Each subject will receive one of five possible dosages of nebulized sodium nitroprusside. The dosage will be determined by the 3 + 3 dose escalation design. Only a maximum of six patients will be given a particular dosage. Arterial blood gases will be drawn at 0 min, 15 min, 30 min and 45 min during nebulized sodium nitroprusside administration. Vitals signs will be recorded every five minutes. No changes to ventilator settings or vasopressor dosage or fluid administration will be allowed.
16170646|NCT01619254|Behavioral|Hand washing with soap and hand finger nail clipping|Assess the impact of hand washing with soap and nail clipping on child health
16170647|NCT01619241|Other|PET/CT|F-18 FLT PET/CT
16170648|NCT01619202|Behavioral|Risk Anticipation -Perception Training|Web-based computer training program designed to teach novice teen drivers how to properly scan for hazards
16170649|NCT01619189|Biological|epithelial stem cells cultured|transplantation of allogeneic or autologous limbal epithelial stem cells cultured on human amniotic membrane with no feeders
16170654|NCT01619176|Drug|methotrexate|methotrexate: 7.5mg/week to 15mg/week for 3 months
16170655|NCT01619176|Drug|non-steroidal anti-inflammatory drug (NSAID)|NSAID: 100mg twice a day for 3 months
16170656|NCT01619176|Drug|leflunomide|leflunomide: 20mg/day for 3 months
16170657|NCT01619176|Procedure|Acupuncture|"30 minutes acupuncture every other day for 3 months.
~Basic acupoints: Zusanli, st36; Taixi，KI3）; Shenxu, BL23 Additional acupoints due to personal condition: Waiguan，SJ5; Baxie，Ex-UE9;Yinlingquan，(SP9）; Quchi，LI11; Yanglingquan，GB34; Xuehai，SP10; Dazhu，BL11; Dazhui，DU14; Pixu，BL20."
16170658|NCT01619163|Drug|Placebo|
16170659|NCT01619163|Drug|Prednisolone|low dose, 7.5 mg/day
16170660|NCT01619150|Drug|Etoricoxib, followed by placebo (matching tablet, without active ingredient)|Sequence 1: 1 tablet of 60 mg etoricoxib daily for 4 weeks, for oral use. Sequence 2: 1 tablet of matching placebo daily for 4 weeks, for oral use.
16170661|NCT01619150|Drug|Placebo (matching tablet, without active ingredient), followed by etoricoxib|Sequence 1: 1 tablet of matching placebo daily for 4 weeks, for oral use. Sequence 2: 1 tablet of 60 mg etoricoxib daily for 4 weeks, for oral use.
16170662|NCT01619137|Drug|water and soap|water and soap for 6-8 hours per day.
16170663|NCT01619137|Drug|Povidone-iodine And normal salin treatment|use of Povidone-iodine And normal salin treatment for irrigation of ununion laparatomy or episiotomy wound.
16170664|NCT01619111|Drug|standard chemo- or endocrine therapy|"standard chemo- or endocrine therapy:
~Monochemotherapy (containing one of the following): docetaxel, paclitaxel, vinorelbine, capecitabine, NPLD (non-pegylated liposomal doxorubicin)
~Endocrine therapy: aromatase inhibitors (anastrozole, letrozole, exemestane)"
16170665|NCT01619111|Drug|standard chemo- or endocrine therapy + Lapatinib|"Lapatinib
~+ standard chemo- or endocrine therapy:
~Monochemotherapy (containing one of the following): docetaxel, paclitaxel, vinorelbine, capecitabine, NPLD (non-pegylated liposomal doxorubicin)
~Endocrine therapy: aromatase inhibitors (anastrozole, letrozole, exemestane)"
16170666|NCT01619098|Other|Patient Navigator|In addition to usual care, the intervention adds the services of a community health worker, the Patient Navigator (PN), for study patients. The PN participates in bedside meetings, facilitates communication between the patient and the primary care team, conducts weekly outreach phone calls to further address patient needs, and makes reminder calls prior to all medical appointments to facilitate timely outpatient follow-up.
16170667|NCT01619098|Other|Usual care|Usual care includes provision of a Home Care Plan (HCP) to patients at discharge, and electronic transmission of HCP to PCP with telephone follow-up by primary care RN
16170668|NCT01619085|Drug|BIBF 1120|BIBF 1120 Bis in die (twice a day)
16170669|NCT01619072|Other|Misoprostol + referral|800 mcg of sublingual misoprostol (four tablets of 200 mcg misoprostol) + standard of care (referral to higher level care)
16170670|NCT01619072|Other|Placebo + referral|Placebo (4 tablets resembling misoprostol) + standard of care (referral to higher level care)
16170671|NCT01619059|Drug|Saxagliptin|Tablets, Oral, 5 mg, Once daily, Up to 52 weeks
16170672|NCT01619059|Drug|Dapagliflozin|Tablets, Oral, 10 mg, Once daily, Up to 52 weeks
16170673|NCT01619059|Drug|Metformin IR|Tablets, Oral, ≥ 1500mg, Twice daily, Up to 52 weeks
16170674|NCT01619059|Drug|Placebo matching with Saxagliptin|Tablets, Oral, 0 mg, Once daily, Up to 52 weeks
16170675|NCT01619046|Biological|GreenGene™ F and an approved recombinant Factor VIII product|one 50 IU/kg, intra-venous infusion over 5 minutes, Infusion rate < 10 mL/min
16170676|NCT01619046|Biological|GreenGene™ F|intra-venous infusion, 30 ± 5 IU/kg infusions 3 times per week with dose escalation to 45 ± 5 IU/kg if appropriate, for 50 exposure days
16170677|NCT01619046|Biological|GreenGene™ F|"intra-venous infusion,
~On-demand safety and efficacy substudy:
~minor bleed = 10-20 IU/kg moderate bleed = 15-30 IU/kg major bleed = 30-50 IU/kg"
16170678|NCT01619046|Biological|GreenGene™ F|"intra venous infusion,
~Surgical substudy:
~Minor surgery including tooth extraction = Post in fusion FVIII level of 60-100% of normal. A single bolus infusion (30-50 IU/kg) beginning within one hour of the operation. Optional additional dosing every 12 to 24 hours as needed to control bleeding.
~Major surgery = Pre- and post infusion FVIII level 80-120% of normal. Preoperative bolus infusion: 40-60 IU/kg. Verified 100% activity prior to surgery. Maintenance bolus infusion (40-60 IU/kg) repeat infusions every 8 to 24 hours, depending on the desired level."
16170679|NCT01619033|Drug|BF2.649|single dose 20 mg
16170680|NCT01619020|Dietary Supplement|Flaxseed Lignans|We will use a specially formulated dietary lignan supplement (Lignan Research Inc., San Diego, CA) as a source of lignans for the lignan challenge in the screening study and as a daily supplement in the intervention. It is a flaxseed extract that contains SDG (269 mg/g; 50 mg/capsule), pinoresinol diglucoside (160 mg/g), and lesser amounts of caffeic (50 mg/g), ferulic (40 mg/g) and coumaric acids (30 mg/g). Lignan capsules and placebo capsules will be prepared by Lignan Research, Inc., a well-established supplement company that follows GMP.
16170681|NCT01619007|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Patients who will be treated for an acute deep vein thrombosis (DVT) with rivaroxaban
16170682|NCT01619007|Drug|Standard of care|Patients who will be treated for an acute deep vein thrombosis (DVT) with current standard of care comprising e.g. of initial treatment with low-molecular weight heparin or fondaparinux, followed by oral Vitamin-K antagonist for at least 3 months
16170683|NCT01618994|Procedure|Performing robotic supracervical hysterectomy|All groups were recorded, times and graded on their performance during a robotic supracervical hysterectomy
16170684|NCT01618981|Procedure|pace make active/inactive cross over|
16170685|NCT01618968|Drug|MTX|"Treatment A - 1 dose (4, 6, 8 or 10 tablets respectively to make up 10 mg, 15 mg, 20 mg or 25 mg MTX - per subject's dose group)
~Treatment B - SC injection using VIBEX MTX device into abdomen (VIBEX MTX device pre-filled with 10 mg, 15 mg, 20 mg or 25 mg MTX)
~Treatment C - SC injection using VIBEX MTX device into thigh (VIBEX MTX device pre-filled with 10 mg, 15 mg, 20 mg or 25 mg MTX)"
16170686|NCT01618955|Device|VIBEX MTX|Self-administration of Single Dose of SC MTX using Vibex MTX 10 mg, 15 mg, 20 mg or 25 mg Device
16170687|NCT01618942|Device|pressure algometer|
16170688|NCT01618929|Drug|Montelukast|Placebo and montelukast (5 mg for 6-14 years of age and 10 mg for 14-18 years of age once a day) will be given following one another in 4 weeks periods including a 2 weeks wash-out period in between in a cross over design.
16170689|NCT01618916|Drug|LY3015014|Administered SC
16170690|NCT01618916|Other|Placebo|Administered SC
16170691|NCT01618903|Drug|Levetiracetam|Levetiracetam 1.500 mg (500 mg/ 5 mL vials) administered as a 45 minutes intravenous infusion diluted in 100 mL 0.9 % saline solution in the morning of Day 1.
16170692|NCT01618903|Drug|Levetiracetam|Levetiracetam single oral administration of 3 tablets of 500 mg immediate release tablet.
16170693|NCT01618890|Procedure|Hepatic venous pressure gradient measurement|"Perform baseline HVPG measurement, then start propranolol 20 mg orally twice daily (BID), increase the dose stepwise to maximum tolerated dose. After 4 weeks a second HVPG is performed.
~In hemodynamic nonresponders from the study arm, repeated endoscopic band ligation is performed in daycare setting with intervals of 2-4 weeks.
~In hemodynamic responders (HVPG second measurement< 12 mmHg or >20% reduction in HVPG compared to baseline) beta-blockers are continued until end of follow-up."
16170694|NCT01618877|Drug|Levetiracetam|Levetiracetam 1.500 mg (500 mg/ 5 mL vials) administered as a 45 minutes intravenous infusion diluted in 100 mL 0.9 % saline solution every 12 hours from the morning of Day 3 (it is the first day in Part B) to the morning of Day 7 (it is the 5th day in Part B).
16170695|NCT01618877|Other|Placebo|15 mL 0.9 % saline solution added to 100 mL 0.9 % saline solution, administered as a 45 minutes intravenous infusion every 12 hours from the morning of Day 3 ( it is the 1st day in Part B) to the morning of Day 7 (it is the 5th day in Part B).
16170696|NCT01618864|Device|Luxe|Self treatment at home in the peri-orbital and cheeks areas. Frequency: Daily treatment for 4 weeks followed by bi-weekly treatments for additional 4 weeks.
16170697|NCT01618851|Radiation|Radiotherapy with IMRT and CyberKnife Boost|"Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the PTV and critical normal structures. The homogeneous CT model shall be used.
~The prescribed PTV dose of 19.5 Gy shall be given in 3 fractions using the CyberKnife. At least three fiducials should be identified for each treatment. If fewer than three fiducials can be tracked, then additional fiducials will be placed, and the patient replanned. Fiducial locations in the images will be extracted and compared to the fiducial locations in the CT scans to estimate target movements.
~For IMRT, Daily doses of 180 cGy are to be delivered to the PTV 5 days a week to a total dose of 4500 cGy in 25 fractions."
16170698|NCT01618838|Radiation|CyberKnife radiosurgery|"Treatment Planning:
~Inverse planning using the CyberKnife planning system will be employed. The treatment plan used for each treatment will be based on an analysis of the volumetric dose including dose-volume histogram (DVH) analyses of the Planning Treatment Volume (PTV) and critical normal structures. The homogeneous CT model shall be used. Number of paths and beams used for each patient will vary and will be determined by the selected individual treatment plan. To reduce overall treatment time and total monitor units, 150-200 non-zero beams are recommended. No more than 250 beams shall be employed. Tuning structures shall be employed to minimize conformality index (CI) and new conformality index (nCI), preferably yielding values less than 1.20 and 1.25, respectively."
16170699|NCT01618825|Drug|Lamotrigine Tablets 25 mg|2 x 25 mg tablet once a day
16170700|NCT01618825|Drug|Lamotrigine|2 x 25 mg tablet once a day
16170701|NCT01618812|Procedure|Lateral lengthening osteotomy of calcaneus|Use of artificial bone graft
16170702|NCT01618799|Drug|Lamotrigine Tablets 25 mg|2 x 25 mg tablet once a day
16170703|NCT01618799|Drug|Lamotrigine|2 x 25 mg tablet once a day
16170704|NCT01618786|Other|SmartCell flooring|SmartCell (SATECH Inc., Chehalis, WA, USA) is a continuous rubber surface layer supported by an array of cylindrical rubber columns 14 mm in diameter, and spaced at 19 mm intervals. It has a surface hardness of 50 durometer. It has been reported to provide approximately 35% peak force attenuation during mechanical tests that simulate falls on the hip. It has also been reported to have minimal effect on balance and mobility of older women during activities of daily living. It will be covered with hospital-grade vinyl and will be inspected regularly for maintenance requirements.
16170705|NCT01618786|Other|Plywood flooring|Plywood flooring covered with the same hospital-grade vinyl as the SmartCell flooring.
16170706|NCT01618773|Drug|0.1% adapalene / 2.5% benzoyl peroxide|topical application
16170707|NCT01618760|Drug|Risperidone Tablet 1 mg|1 mg tablet once a day
16170708|NCT01618760|Drug|Risperidone|1 mg tablet once a day
16170709|NCT01618708|Device|Synvisc-One (hylan G-F 20)|6-mL IA injection
16170710|NCT01618708|Device|Placebo|6 mL injection of phosphate buffered saline
16170711|NCT01618695|Drug|Perampanel|"Core study: 4 milligram (mg) group- Week 0 Once daily 2 milligram per day (mg/day), Week 1 to Week 18 Once daily 4 mg/day; 8 mg group- Week 0 Once daily 2 mg/day, Week 1 Once daily 4 mg/day, Week 2 Once daily 6 mg/day, Week 3 to Week 18 Once daily 8 mg/day; 12 mg group- Week 0 Once daily 2 mg/day, Week 1 Once daily 4 mg/day, Week 2 Once daily 6 mg/day, Week 3 Once daily 8 mg/day, Week 4 Once daily 10 mg/day, Week 5 to Week 18 Once daily 12 mg/day.
~Extension study: 4 mg group- Week 19 to Week 22 Once daily 4 mg/day, Week 23 Once daily 6 mg/day, Week 24 Once daily 8 mg/day, Week 25 Once daily 10 mg/day, Week 26 to Week 75 or more Once daily 12 mg/day; 8 mg group- Week 19 to Week 22 Once daily 8 mg/day, Week 23 Once daily 10 mg/day, Week 24 to Week 75 or more Once daily 12 mg/day; 12 mg group- Week 19 to Week 75 or more Once daily 12 mg/day."
16170712|NCT01618695|Drug|Placebo|"Core study: Week 0 to Week 18 Once daily placebo.
~Extension study:
~Week 19 to Week 22 Once daily placebo, Week 23 Once daily perampanel 2 mg/day, Week 24 Once daily perampanel 4 mg/day, Week 25 Once daily perampanel 6 mg/day, Week 26 Once daily perampanel 8 mg/day, Week 27 Once daily perampanel 10 mg/day, Week 28 to Week 75 or more Once daily perampanel 12 mg/day."
16170713|NCT01618669|Drug|Regadenoson|Administered as an intravenous (IV) bolus
16170714|NCT01618669|Procedure|Single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI)|
16170715|NCT01618656|Drug|PF-04457845|Study medication will be administered at 4mg by mouth daily for four weeks.
16170716|NCT01618656|Drug|Placebo|Sugar pill
16170717|NCT01618643|Procedure|Acetic acid chromoendoscopy|"Prospective observational pilot study.
~We would examine patients with Barrett's epithelium that is either healthy or has suspected areas of neoplasia. We will apply acetic acid spray to areas of healthy Barrett's metaplasia and time how long it takes for the aceto whitening to disappear. We will repeat this in cases referred with SM invasive cancer, intramucosal cancer, suspected high grade dysplasia and possible low grade dysplasia. We will record how long it takes for the acetowhitening to disappear. We will biopsy these areas to confirm the diagnosis.
~We will correlate the histology to the aceto-whitening time to see if there is a correlation between the degree of neoplasia and the aceto-whitening time after acetic acid dye spray."
16170718|NCT01618630|Dietary Supplement|EAA Supplementation + Exercise Training|Amino acids in drinks between meals for exercise training period.
16170719|NCT01618630|Dietary Supplement|Placebo + Exercise Training|Placebo supplementation as drinks in between meals for exercise training period.
16170720|NCT01618617|Dietary Supplement|High dose Multistrain probiotic, 100 billion cfu/day|100 billion cfu live bacteria (60 billion cfu bifidobacterium cultures and 40 billion lactobacillus cultures).
16170721|NCT01618617|Dietary Supplement|Low dose Multistrain probiotic, 15 billion cfu/day|15 billion cfu live bacteria (9 billion cfu bifidobacterium cultures and 6 billion lactobacillus cultures).
16170722|NCT01618604|Procedure|Quantitative Sensory Testing|following the standardized protocol of DFNS
16170723|NCT01618604|Procedure|Conditioned Pain Modulation|test stimulus by hot thermode conditioned stimulus by cold water bath
16170724|NCT01618604|Procedure|Repetition of four QST parameters|"warm detection threshold (WDT)
~cold detection threshold (CDT)
~mechanical detection threshold (MDT)
~mechanical pain threshold (MPT)"
16170725|NCT01618591|Drug|Single dose rifaximin 1650 mg|Rifaximin 1650 mg as a single dose plus loperamide 4 mg initially followed by 2 mg after each unformed stool, not to exceed 16 mg/day for 2 days
16170726|NCT01618591|Drug|Single dose azithromycin 500 mg|Azithromycin 500 mg as a single dose plus loperamide 4 mg initially followed by 2 mg after each unformed stool, not to exceed 16 mg/day for 2 days
16170727|NCT01618591|Drug|Single dose levofloxacin 500 mg|Levofloxacin 500 mg as a single dose plus loperamide 4 mg initially followed by 2 mg after each unformed stool, not to exceed 16 mg/day for 2 days
16170728|NCT01618591|Drug|Single dose azithromycin 1000 mg plus loperamide|Azithromycin 1000 mg as a single dose plus loperamide 4 mg initially followed by 2 mg after each unformed stool, not to exceed 16 mg/day for 2 days
16170729|NCT01618591|Drug|Single dose azithromycin 1000 mg plus placebo|Azithromycin 1000 mg as a single dose and placebo in lieu of loperamide
16170730|NCT01618578|Procedure|rubber hand illusion|"There were three consecutive trials of the RHI:
~one control trial: asynchronous condition (3 Min.)
~two experimental trials (conducted on both hands):synchronous condition (3 Min.),additionally watching the prosthesis being threatened (20 sec.)"
16170731|NCT01618565|Procedure|Hands-On Training|one-time, 30 minute hands-on training
16170732|NCT01618565|Procedure|Demonstration|30 minutes passive training
16170733|NCT01618552|Behavioral|SEE IT training|Standardized patient instructors provide a scripted intervention to train primary care physicians in the use of self-efficacy enhancing interviewing techniques (SEE IT) during office visits with patients who have coexisting depression and diabetes
16170734|NCT01618552|Other|Knowledge enhancement|Brief video clip designed to increase primary care physician awareness of new medication treatments for diabetes
16170735|NCT01618539|Drug|propofol|varying intravenous dosages
16170736|NCT01618526|Dietary Supplement|Western Style Diet|Cross over design with two intervention diet: Healthy Carbohydrate Diet with approximally 55 grams of dietary fibers (Arabinoxylans and Resist Starch) compared with a Western Style Diet with a low content of dietary fibers.
16170737|NCT01618526|Dietary Supplement|Healthy Carbohydrate Diet|Cross over design with two intervention diet: Healthy Carbohydrate Diet with approximally 55 grams of dietary fibers ( Arabinoxylans and Resistent Starch) compared with Western Style Diet with low content of dietary fibers
16170738|NCT01618513|Drug|Sandostatin® LAR|Intramuscular injections, dosage based on either GH or IGF-I levels.
16170739|NCT01618487|Procedure|Arthroscopic tenotomy|This is a surgical procedure where small incisions are made and a scope is used to see the tendon and release it.
16170740|NCT01618487|Procedure|Open tenotomy|This involves opening the skin on the arm up to expose the muscle and tendon. There is a total of 1 incision made.
16170741|NCT01618487|Procedure|Debridement and repair|This involves using an arthroscopic technique (using a scope and a small incision) to go in and remove any tissue that is diseased/does not belong and repairing the tear(s) in the tendon. There is a total of 1-2 incisions made.
16170742|NCT01618474|Drug|DX|Docetaxel 60mg/m2, intravenous infusion, day 1; Capecitabine 1000mg/m2, oral administration, twice a day, day1-14; 3 weeks a cycle for 8 consecutive cycles.
16170743|NCT01618474|Drug|XELOX|oxaliplatin 130mg/m2, intravenous infusion, day 1; Capecitabine 1000mg/m2, oral administration, twice a day, day 1-14, 3 weeks a cycle for 8 consecutive cycles
16170744|NCT01618461|Behavioral|Drug indication icons|Icons illustrate the purpose of each medication
16170745|NCT01618461|Behavioral|Structured instructions|Graphical format shows what time(s) of day each medication should be taken
16170746|NCT01618448|Drug|Tolvaptan|Tolvaptan 15mg once daily
16170747|NCT01618448|Drug|Placebo|Placebo
16170748|NCT01618435|Biological|i-FACTOR|i-FACTOR mixed with autologous bone from the decompression placed in the operation site for enhancing fusion
16170749|NCT01618422|Other|Directly Observed Therapy (DOTS) plus|The regimen used to treat MDR-TB comprises 5 to 6 drugs to which the organism is or likely to be susceptible for the initial 6 months, and then 3 to 4 drugs subsequently. In addition, TB cases with rifampicin resistance but not amounting to MDR-TB are also at risk of unfavourable treatment outcomes. The availability of pretreatment susceptibility test results will provide a guide in selection of drugs in treating such cases.
16170750|NCT01618422|Other|Directly Observed Therapy (DOTS)|The DOTS strategy (current strategy) consists of the following measures: political commitment, case detection through bacteriologic evaluation, standardized treatment with supervision and patient support, an effective drug supply system, and a reporting and recording system that allows assessment of treatment. The standard regimen for treatment of new cases of pulmonary TB consists of 6 months treatment, with 4 drugs in the initial phase including isoniazid, rifampicin, pyrazinamide, and either ethambutol or streptomycin, followed by two drugs in the continuation phase including isoniazid and rifampicin. In the treatment of previously treated cases, a standard regimen consisting of 8 months treatment will be used.
16170751|NCT01618409|Behavioral|PictureRx card|An illustrated format of medication instructions that includes pictures of the medications and icons to illustrate their purpose
16170752|NCT01618396|Drug|Sedation drug (Propofol and Midazolam)|Septic patients, after intubation, were initially sedated with propofol. During the second day of mechanical ventilation, propofol infusion was interrupted. When the patient awoke, the sedative drug was changed to midazolam. Sedation target was a Ramsay Scale score of 4 to 5.
16170753|NCT01618383|Other|colonoscopy or rectosigmoidoscopy|Usual procedure
16170754|NCT01618370|Drug|Radium-223 dichloride (BAY88-8223)|One injection to be administered every 4 weeks up to 6 injections. The dose per injection is 50 kBq/kg body weight.
16170755|NCT01618357|Radiation|Radiation|Patients will receive radiation therapy at a dose of 2.35 Gy per fraction to the breast and regional nodal region for 16 fractions to a total dose of 37.5 Gy. Treatments will be given Monday through Friday. Radiation therapy will start on day 1 of Veliparib.
16170756|NCT01618357|Procedure|Lumpectomy/Mastectomy|Resection of breast cancer.
16170757|NCT01618357|Drug|Veliparib|Pills to be taken twice a day during radiation and for one week after completion of radiation for a total of 29 days.
16170758|NCT01618331|Behavioral|Regular exercise|Duration: 3 session each week, in 12 week. Intensity: 70 % of VO2max. Type: cycle-ergometer exercise.
16170759|NCT01618331|Dietary Supplement|Protein-carbohydrate supplementation|Dosage: 45g powder mixed in 0.5 L water After each exercise session, 3 times each week, in 12 weeks.
16170760|NCT01618305|Drug|Lamivudine/zidovudine|"Participants received one lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet twice a day from entry through delivery*.
~* Participants may have received a locally supplied nucleoside reverse transcriptase inhibitor (NRTI) backbone in place of lamivudine/zidovudine with permission of the protocol team obtained prior to randomization."
16170761|NCT01618305|Drug|Efavirenz|Participants received one 600 mg tablet of efavirenz each night from entry through delivery.
16170762|NCT01618305|Drug|Raltegravir|Participants received one 400 mg raltegravir tablet twice a day from entry through delivery.
16170763|NCT01618292|Procedure|Robotic sacral colpopexy|Patients who underwent robotic assisted sacral colpopexy for the treatment of pelvic organ prolapse
16170764|NCT01618266|Drug|dexamethasone intravitreal implant|dexamethasone intravitreal implant 700 μg administered into the eye according to physician judgment.
16170765|NCT01618253|Drug|Sorafenib|Sorafenib 400 mg PO bid will be started two weeks prior to initiation of radiation therapy (RT) and continue until the end of protocol specified radiation dose.
16170766|NCT01618253|Radiation|Conventional fractionation (2 Gy per day) external beam radiation therapy|"Patients will be stratified by the maximum diameter of HCC in any plane (≤10 cm or >10 cm) based on post-TACE, contrast enhanced MRI or CT. If only 1 lesion is present, the maximum diameter of that lesion in any plane determines stratification. If >1 but ≤3 lesions are present, the sum of the maximum diameter in any plane of all the lesions determines stratification.
~The MTD will be determined utilizing a standard 3 + 3 dose escalation scheme (4 Gy increase per bin). For lesions ≤10 cm, the starting RT dose bin will be 42 Gy and escalate to a pre-determined maximum of 62 Gy if no DLT's are experienced. For lesions >10 cm, the starting RT dose bin will be 40 Gy and escalate to a pre-determined maximum of 52 Gy if no DLT's are experienced."
16170767|NCT01618240|Other|Muscle Strength Measurement|MRC score (0-60) is a clinical assessment of muscle power on abduction of the arm, flexion of the forearm, extension of the wrist, flexion of the leg, extension of the knee and dorsal flexion of the foot with the score of (0-5) on each measurement
16170768|NCT01618240|Other|Ventilator|A mechanical ventilator is used to assist or replace spontaneous breathing.
16170769|NCT01618227|Device|Joint Active Systems (JAS) Static progressive splint|Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises throughout the study. Upon receipt of the splint, subjects will be instructed in proper application and use by their treating therapist or a representative of the company. Subjects will be instructed to follow the daily splint wearing protocol provided by the device manufacturer.
16170770|NCT01618227|Procedure|Rehabilitation without splinting|Subjects will have a standard rehabilitation program including physical or occupational therapy and home exercises without additional splinting.
16170771|NCT01618214|Drug|biphasic insulin aspart 30|Dose individually adjusted, administered subcutaneously (s.c., under the skin) twice daily.
16170772|NCT01618188|Drug|Faster-acting insulin aspart|A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration.
16170773|NCT01618188|Drug|insulin aspart|A single dose of 0.2 U/kg body weight for subcutaneous (s.c., under the skin) administration.
16170774|NCT01618175|Device|Home oxygen therapy|"Oxygen will be provided using a generator, through nasal prongs at a flow rate up to 1 L/min.
~During home stay the parents will be guided on how to suspect signs of clinical deterioration. General treatment: If oxygen saturation by pulse oximeter is greater than 92%, the oxygen will be reduced by a quarter liter per minute while monitoring for 15 minutes. If oxygen saturation decreased to less than 92% of the child will remain with the best previous oxygen flow until the next visit. Once the child reaches - 0.06 l / min for 15 minutes, he will will be checked back on room air. Cessation of oxygen therapy: when the oxygen saturation remains above 92% on room air. Every day that no home visit was performed a phone call will be done and follow-up questionnaire will be filled daily, including oxygen saturation registration."
16170775|NCT01618162|Drug|insulin degludec/liraglutide|Injected subcutaneously (under the skin) once daily. Dose individually adjusted.
16170776|NCT01618162|Drug|placebo|Injected subcutaneously (under the skin) once daily.
16170777|NCT01618149|Radiation|dual energy x-ray absorptiometry|before the surgery of total knee arthroplasty and after the surgery 6 months and 12 months
16170778|NCT01618136|Drug|E7449 alone|Will be administered as single agent orally, once daily (QD) continuously in 28-day cycles to determine the MTD. In these subjects, a food-effect component will be conducted under fed/fasted conditions to determine the effect of food on the bioavailability of E7449 administered orally QD.
16170779|NCT01618136|Drug|E7449 plus TMZ|Dose escalation,will be administered orally, once daily for 7 consecutive days along with 150 mg/m2/d TMZ administered orally, once daily for 5 consecutive days in 28-day cycles to determine the MTD of E7449 in combination with TMZ.
16170780|NCT01618136|Drug|E7449 plus carboplatin and paclitaxel|Dose escalation, E7449 will be administered orally, once daily continuously in 21-day cycles along with carboplatin and paclitaxel, which will be administered via i.v. infusion on Day 1 of the cycle only, to determine the MTD of E7449 in combination with carboplatin and paclitaxel.
16170781|NCT01618110|Device|Transcranial Magnetic Stimulation (Magstim, Rapid)|Superficial rTMS, directed at right PFC, power of 100% of MT, 10Hz for 4 seconds, intervals of 30 seconds, 42 trains.
16170782|NCT01618110|Other|Placebo Treatment|Sham coil (minimal magnetic field, same noise and feeling)
16170783|NCT01618097|Behavioral|DVD Decision Aid|Patients will receive the DVD decision aid to view, and follow up 3 days and 30 days post visit.
16170784|NCT01618097|Behavioral|Internet Based Decision Aid|Patients will receive the OA specific internet based decision aid to view, and follow up 3 days and 30 days post visit
16170785|NCT01618084|Device|Tritanium acetabular component|Total hip arthroplasty using a tritanium uncemented acetabular component
16170786|NCT01618071|Dietary Supplement|High-fat meals varying in their fatty acid composition|70 g fat incorporated into a muffin and milkshake meal, consumed following fasting baseline measurements
16170787|NCT01618058|Drug|No Investigational Product|"This study is observational in nature and no investigational product will be used.
~Groups: ARV-Treated Participants, ARV-Naive Participants"
16170788|NCT01618045|Dietary Supplement|Fermented Papaya Preparation (FPP)|Participants will take fermented papaya preparation (FPP) for a total of 6 weeks (3 grams, three times each day for a total of 9 grams per day). The participants will attend 5 study visits and have their blood draw at each visit (5 total times).
16170789|NCT01618032|Other|HVLA|High velocity and low amplitude manipulation in traction of subtalar jonit
16170790|NCT01618032|Other|MWM|Mobilization with movement as Mulligan for increase dorsiflexion of the ankle in weight bearing
16170791|NCT01618032|Other|placebo|Manual contact during a period of time similar of teh other interventions
16170792|NCT01618019|Dietary Supplement|Omega-3 fatty acid|5 capsules/day of either n-3 PUFA, containing 2.09 g eicosapentaenoic acid and 1.165 g docosahexaenoic acid
16170793|NCT01618019|Dietary Supplement|Placebo|5 capsules/day of placebo containing sunflower with oleic acid (DSM Nutritional products, Switzerland)
16170794|NCT01618006|Drug|Aspirin|Aspirin 81mg po daily x 7days or end of hospitalization. First dose administered on post op day 1.
16170795|NCT01618006|Drug|Aspirin|Aspirin 325mg po daily x 7days or end of hospitalization. First dose administered on post op day 1.
16170796|NCT01618006|Drug|Aspirin|Aspirin 81mg po four times daily x 7days or end of hospitalization. First dose administered on post op day 1.
16170797|NCT01617980|Other|Multimodal hypoxia imaging|Patients with inoperable, stage III non-small cell lung cancer receive serial 18F-FMISO dPET-CT and functional MRI investigations prior, during and post radiation treatment
16170798|NCT01617967|Drug|Patisiran|Participants received a single dose of patisiran as an intravenous (IV) infusion on Day 0 and Day 28 (Q4W). Optional cohorts received an alternative dosing regimen (once every 3 weeks [Q3W]: Day 0 and Day 21) and an alternative premedication regimen.
16170799|NCT01617954|Device|MammaPrint|All subjects
16170800|NCT01617941|Drug|BGG492|
16170801|NCT01617941|Drug|Placebo|In patients not tolerating a dose of 75 mg BID BGG492/Placebo the dose can be decreased to 50 mg BID and this dose will be continued for the rest of the planned treatment. Those patients who are not tolerating 50 mg BID BGG492/Placebo will be discontinued from the trial.
16170802|NCT01617928|Drug|veliparib (ABT-888)|Dosing orally twice daily starting Day 1 through day 7 of each cycle. Decisions to move to the next cohort will be based on evaluation of DLTs in the current cohort. Decisions will be made with a discussion between the Sponsor and the principal investigator to dose escalate or de-escalate or add more subjects to the cohort.
16170803|NCT01617928|Drug|carboplatin|Carboplatin will be administered on Day 3 of each cycle, intravenously.
16170804|NCT01617928|Drug|paclitaxel|Paclitaxel will be administered on Day 3 of each cycle, intravenously.
16170805|NCT01617889|Other|Experimental powdered milk-based infant formula with an alternate fat blend|formula to be consumed ad lib
16170806|NCT01617889|Other|A powdered milk-based infant formula, standard fat blend|formula to be consumed ad lib
16170807|NCT01617850|Other|Supervised physical exercise training x3 weekly for 12 weeks|Physical exercise training 1 hour per session. The exercise rehabilitation programme is carried out as group training with individual supervision. At each exercise session two experienced physiotherapist are leading the physical exercise training. Standardized physical exercise guidelines for each training session is described and followed. It consists of the following interventions: Warm up, aerobe fitness, muscle strength training and individual education and instruction in life stills changes in relation to physical activity.
16170808|NCT01617850|Other|Supervised physical exercise training x2 weekly for 8 weeks|Physical exercise training is carried out for 1 hour per session. The exercise rehabilitation programme is carried out as group training with individual supervision. At each exercise session two-experienced physiotherapist are leading the physical exercise training. Standardized physical exercise guidelines for each training session is described and followed. It consists of the following interventions: Warm up, aerobe fitness, muscle strength training and individual education and instruction in life stills changes in relation to physical activity.
16170809|NCT01617837|Device|P6 acupressure band|Comparison between groups 0-48 hours postoperatively.
16170810|NCT01617837|Other|Placebo band|Comparison between groups 0-48 hours postoperatively
16170811|NCT01617824|Drug|Linagliptin|Linagliptin 5 mg tablets for 4 days
16170812|NCT01617824|Drug|Placebo|Placebo tablets for 4 days
16170813|NCT01617811|Procedure|epidural anesthesia and analgesia|"A thoracic epidural catheter (T8-10) was placed in group E. A bolus of 8ml 1% lidocaine with 0.375% ropivacaine was administered 15min before skin incision, followed by 5-8 ml/hr infusion during surgery in group E.
~Postoperative analgesia by PCEA in group E (concentration: 0.1% ropivacaine + 0.1μg/ml sufentanil, loading dose: 4ml, infusion rate: 8ml/hr, bolus: 4ml, 1hr limit: 16ml) and lasting for 48hr and PCIA in group G (concentration: 1μg/ml sufentanil, loading dose: 4ml, bolus: 2ml, 4hr limit: 30ml).
~Both group received general anesthesia maintaining with 1-2% end tidal sevoflurane together with TCI of propofol (target plasma concentration, 2-3µg/ml), continuous infusion of remifentanil (0.10 - 0.20 μg/kg/min) and cis-atracurium intermittently as needed."
16170814|NCT01617798|Drug|Supplemental metolazone diuresis|Patients in the Study Arm will receive supplemental diuresis with metolazone 2.5 mg per dobhoff tube twice daily, in addition to furosemide as the primary team sees fit.
16170815|NCT01617798|Drug|Placebo Comparator: Control-- furosemide (lasix) only|Control arm will receive furosemide as monotherapy for diuresis
16170816|NCT01617772|Drug|Atorvastatin|Atorvastatin 20 mg
16170817|NCT01617772|Drug|L-Carnitine|1000mg L-carnitine
16170818|NCT01617772|Drug|Placebo|Identically looking placebo
16170819|NCT01617746|Drug|Ambrisentan|5mg od two weeks
16170820|NCT01617746|Drug|Bosentan|62.5mg bd two weeks
16170821|NCT01617746|Drug|Placebo|bd for two weeks
16171089|NCT01615653|Procedure|EUS|EUS Guided Therapy
16170822|NCT01617733|Drug|Pasireotide|4 Weeks pasireotide 0.6mg s/c injections twice daily followed by 24 weeks treatment with pasireotide LAR 60mg every 28 days with dose reductions if poor tolerability is encountered
16170823|NCT01617707|Drug|Midazolam plus propofol|In both study arms, patients who were 20-70 years of age received an initial intravenous bolus of 0.05mg/kg of midazolam, while patients ≥71 years of age received an initial intravenous dose of 1mg of midazolam. After 2min following this initial dose of midazolam, the conventional sedation group received additional boluses as needed of 1 to 2 mg of midazolam at the discretion of the endoscopist, to target moderate sedation. The BPS group received an initial 0.5mg/kg bolus of intravenous propofol at 2min after midazolam administration. Subsequent incremental boluses of 10 to 20 mg of propofol were allowed to be given at the discretion of the endoscopist every 30s to target moderate sedation.
16170824|NCT01617707|Drug|Midazolam|In both study arms, patients who were 20-70 years of age received an initial intravenous bolus of 0.05mg/kg of midazolam, while patients ≥71 years of age received an initial intravenous dose of 1mg of midazolam. After 2min following this initial dose of midazolam, the conventional sedation group received additional boluses as needed of 1 to 2 mg of midazolam at the discretion of the endoscopist, to target moderate sedation. The BPS group received an initial 0.5mg/kg bolus of intravenous propofol at 2min after midazolam administration. Subsequent incremental boluses of 10 to 20 mg of propofol were allowed to be given at the discretion of the endoscopist every 30s to target moderate sedation.
16170825|NCT01617694|Drug|dexmedetomidine|Fifteen minutes before the end of surgery, the first practitioner replace the syringe of remifentanil as new one; new syringe contains remifentanil in remifentanil group (Group R), and normal saline in dexmedetomidine group (Group D), respectively. There are no drug labeling in the new syringe, so the second practitioner can't know which drug was contained in the new syringe. Simultaneously, the second practitioner remifentanil concentration on monitor of TCI pump will be adjusted to 2.0 ng•ml-1. Ten minutes before the end of surgery, 10 ml of dexmedetomidine 0.5 mcg•kg-1 mixed with normal saline will be given for 5 min in Group D; in Group R, 10 ml of normal saline will be given by the first practitioner.
16170826|NCT01617694|Drug|Normal Saline|
16170827|NCT01617681|Drug|VAL489|Valsartan 3mg/kg oral solution
16170828|NCT01617681|Drug|VAL489 matching placebo|Valsartan 3 mg/kg oral solution
16170829|NCT01617668|Drug|LCL161|LCL161 was available as 300 mg, tablets, which was supplied in child-resistant bottles.
16170830|NCT01617668|Drug|paclitaxel|"Commercially available paclitaxel was sourced locally by each study site. Generic paclitaxel could be used for study treatment.
~iv 80mg/m2"
16170831|NCT01617655|Drug|Alirocumab|Solution for subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre filled pen).
16170832|NCT01617655|Drug|Placebo (for alirocumab)|Solution for subcutaneous injection in the abdomen, thigh, or outer area of the upper arm by self-injection or by another designated person using auto-injector (also known as pre filled pen).
16170833|NCT01617655|Drug|Lipid Modifying Therapy (LMT)|Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.
16170834|NCT01617629|Biological|MUC1 Dendritic Cell Vaccine (Cvac)|"The recommended dosing regimen for CAN-003X was every 4 weeks for the first 3 doses and then every 12 weeks for 3 doses, for a total of 6 doses over 44 weeks (Regimen A, applicable to CAN-003 observational Standard of Care patients and CAN-003 Cvac patients that have progressed prior to the fourth dose of Cvac).
~Participants who received more than 3 doses of Cvac in CAN-003 continued with the CAN-003 dosing schedule (Regimen B; Cvac every 4 weeks for a total of 7 doses and then every 8 weeks for 3 doses, for a total of 10 doses over approximately 48 weeks)."
16170835|NCT01617603|Other|Cocoa Polyphenols|20g/d of product, two active products provide 20 mg/d epicatechin, on visiting occasions, an acute dose of 40g product to be given
16170836|NCT01617590|Drug|leflunomide|"Leflunomide 10-20 mg, orally, once daily for up to 48 weeks. Twelve weeks after the initial Leflunomide induction, patients were randomized into two groups (LEF+CTX:LEF+MTX=2:1) if the DAS 28 were higher than 2.6, or continuing leflunomide use without dosing change. Then, the disease activity was assessed using DAS 28 every 12 weeks. The regimen should remain unchanged if the DAS 28 reached to less than 2.6, otherwise, a third (24 weeks) or fourth (36 weeks) DMARs should be added.
~Intravenous CTX was administrated once 200-400mg per 3 weeks."
16170837|NCT01617590|Drug|methotrexate|"MTX 7.5-15 mg, orally, once weekly for up to 48 weeks. Twelve weeks after the initial MTX induction, patients were randomized into two groups (MTX+CTX:LEF+MTX=2:1) if the DAS 28 were higher than 2.6, or continuing MTX use without dosing change. Then, the disease activity was assessed using DAS 28 every 12 weeks. The regimen should remain unchanged if the DAS 28 reached to less than 2.6, otherwise, a third (24 weeks) or fourth (36 weeks) DMARs should be added.
~Intravenous CTX was administrated once"
16170838|NCT01617577|Drug|G-CSF; filgrastim|The drug is administered s.c. at a dose of 10 microg/kg daily for 5 days
16170839|NCT01617577|Drug|Placebo|vehicle (D5W or 5% dextrose solution) is administered subcutaneously daily for 5 days
16170840|NCT01617564|Drug|bipuvacain|PCB with 20ml bupivakain or sodium cloride 9mg/ml will be administered one hour following misorpostol administration (first dose).
16170841|NCT01617564|Other|NaCl|PCB with 20ml sodium chloride (9mg/ml) inactive (sham) comparator
16170842|NCT01617551|Drug|NG-monomethyl-L-arginine (L-NMMA)|Acute L-NMMA treatment (4,5 mg/kg loading dose followed by 3 mg/kg sustain infusion for 1 hour)
16170843|NCT01617538|Drug|atorvastatin|40mg per day,duration for 24 weeks
16170844|NCT01617525|Other|Controlled Feeding Dietary Intervention|All meals will be provided during each 4-week intervention period. Participants must consume all foods provided and must not consume any outside foods during each intervention period.
16170845|NCT01617512|Device|LIS302DL accelerometer|Recording for 24 hours accelerations related to daily physical activity of the patient.
16170846|NCT01617499|Behavioral|Physical activity|The worksite wellness program included cardiovascular health assessments, personal health reports, 8 weeks of pedometer-based walking and tracking activities, and weekly wellness sessions.
16170847|NCT01617486|Behavioral|BALANCE|The intervention will focus on the replacement of 'obesogenic' patterns (such as high soda intake, excess portion size, and sedentary activity) with 'energy' patterns (such as water consumption, appropriate portion size, and walking).
16170848|NCT01617473|Procedure|transplant with PBSCs|mobilized PBSCs for 2 consecutive days
16170849|NCT01617460|Drug|Aripiprazole|Flexibly dose administered orally once daily
16170850|NCT01617447|Drug|Placebo of Aripiprazole|administered orally once daily
16170851|NCT01617447|Drug|Aripiprazole|Flexibly dose administered orally once daily
16170852|NCT01617434|Drug|liraglutide|Maximum 1.8 mg administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial basal insulin analogue regimen plus/minus metformin.
16170853|NCT01617434|Drug|placebo|Placebo administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial basal insulin analogue regimen plus/minus metformin.
16170854|NCT01617421|Behavioral|Yoga|This study used Hatha yoga (influenced by Integral, Iyengar, and Kripalu yoga) which includes postures (asanas), breathing techniques (pranayama) and meditation [9]. Biweekly, 60-minute, bilingual yoga classes were offered for 8 weeks at a yoga studio in Washington, DC. Classes were kept small (3-10 participants) to allow for pose modifications as needed for each participant. Participants were given instructions, bilingual manuals, and yoga equipment to encourage home practice. Participants were asked to keep journals to document the frequency and duration of home practice and their experience while on the study. After the last class, a yoga DVD and a list of local yoga studios were given to encourage continued practice.
16170855|NCT01617369|Device|Hypertonic Saline|2.8% NaCl x 4ml via nebulizer
16170856|NCT01617356|Other|Injection of 20% dextrose/ 0.2% lidocaine|Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 20% dextrose and 0.2% lidocaine.
16170857|NCT01617356|Other|Injection of 1 ml of 0.8 SW/0.2% lidocaine|Injection at 0, 1, and 2 months of 1 ml of a solution consisting of 0.8 sterile water and 0.2% lidocaine.
16170858|NCT01617343|Behavioral|hemifield eye patching (HEP) + optokinetic stimulation (OKS)|"Patients in this arm will wear standard spectacle frames containing noncorrective lenses to which right half-field patches are attached (hemifield eye patching, HEP). In case of patients already wearing prescribed glasses, the patches will be attached to their own glasses. The glasses will be worn all-day for the duration of the treatment phase (seven days) and only be removed for sleeping and face cleaning as well as for the duration of the daily OKS treatment sessions.
~Furthermore these patients will receive daily sessions (20 minutes) of optokinetic stimulation (OKS). Therefore patients will be seated in front of a widescreen monitor, watching a black background with a pattern of various objects (size 1°), which coherently and continuously move to the left at a velocity of 10 °/s."
16170859|NCT01617330|Procedure|Bronchoscopy|Bronchoscopy with endobronchial biopsy sampling and bronchoalveolar lavage (BAL) 18 hours post exposure. Airway inflammation was assessed.
16170860|NCT01617317|Drug|Hyperimmune intravenous immunoglobulin|Single intravenous infusion of 0.4g/kg of H1N1 2009 H-IVIG
16170861|NCT01617317|Drug|Intravenous immunoglobulin|Single intravenous infusion of 0.4g/kg of simple IVIG
16170862|NCT01617304|Other|Dietary intervention|Food made by different cooking methods (boiling/steaming versus frying) and with glucose or fructose water solution
16170863|NCT01617291|Other|Induced therapeutic hypothermia|induced therapeutic hypothermia
16170864|NCT01617278|Device|I-Scan 1|I-Scan 1 has contrast enhancement (CE)and surface enhancement (SE). SE mode highlights light-dark contrast thereby providing more mucosal surface detail.CE mode digitally adds blue to darker areas providing detailed imaging of subtle mucosal irregularities.
16170865|NCT01617278|Device|HD Colon|High definition white light
16170866|NCT01617278|Device|I-Scan 2|I-Scan 2 has contrast enhancement (CE), surface enhancement (SE) and tone enhancement (TE). SE mode highlights light-dark contrast thereby providing more mucosal surface detail.CE mode digitally adds blue to darker areas providing detailed imaging of subtle mucosal irregularities.TE provides a uniform colour image and is intended for detailed inspection of distinct lesions.
16170867|NCT01617265|Procedure|Clinical Procedure to Prevent Oversedation|Sedation and analgesia will be administered according to a bundle of measures aimed at limiting oversedation, including repeated assessment of patients needs and graduate therapeutic response to control pain, discomfort, poor synchrony with the ventilator and agitation. The therapeutic options include non hypnotic anxiolytics, repeated IV hypnotics boluses, short-duration (6 hours) IV hypnotics infusion and round the clock IV hypnotics infusion.
16170868|NCT01617265|Procedure|Usual sedation practice|Sedation and analgesia will be administered according to the usual practices in each participating center.
16170869|NCT01617252|Device|Optiflow / Facial mask|J0: randomization (Optiflow® or facial mask), lung X-ray, kinesiotherapy H0 : clinical examination, blood gas, respiratory frequency H1 : clinical examination, blood gas, respiratory frequency H6 : clinical examination, blood gas J1: clinical examination, blood gas, respiratory frequency, lung X-ray, diaphragmatic echography, kinesiotherapy J2: clinical examination, blood gas, lung X-ray, kinesiotherapy Follow-up (until withdrawal of Optiflow or facial mask): clinical examination, blood gas, lung X-ray, kinesiotherapy
16170870|NCT01617239|Biological|Virosomal influenza vaccine|"Virosomal influenza vaccine with the recommended vaccine composition for season 2011-2012:
~15 μg HA antigen of A/California/7/2009 (H1N1)-like virus
~15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus
~15 μg HA antigen of B/Brisbane/60/2008-like virus
~Intramuscular (i.m.) administration (M. deltoideus or M. vastus lateralis)"
16170871|NCT01617226|Drug|Azacitidine|Azacitidine both arms; 75mg/m^2 by subcutaneous injection for 7 days of a 28-day cycle for up to 6 cycles.
16170872|NCT01617226|Drug|Vorinostat|Vorinostat (with azacitidine) combined therapy arm; 300mg twice daily for 7 days starting on day 3 of each cycle in 28-day cycles for up to 6 cycles.
16170873|NCT01617213|Drug|Melphalan|200 mg/m2/IV
16170874|NCT01617213|Drug|Lenalidomide|10 mg daily continuously for the first 3 months, then increased to 15 mg daily as long as the patient tolerates the drug.
16170875|NCT01617200|Drug|Asenapine|2.5 mg or 5 mg fast dissolving active asenapine tablets administered sublingually, same number of tablets are taken in the morning and the evening
16170876|NCT01617200|Drug|Placebo Asenapine|2.5 mg or 5 mg fast dissolving placebo asenapine tablets administered sublingually, same number of tablets are taken in the morning and the evening
16170877|NCT01617200|Drug|Olanzapine|15 mg film-coated active olanzapine tablets administered orally QD. The time of the active olanzapine dose (either morning or evening) is not disclosed in order to preserve blinding.
16170878|NCT01617200|Drug|Placebo Olanzapine|15 mg film-coated placebo olanzapine tablets administered orally QD. The time of the active olanzapine dose (either morning or evening) is not disclosed in order to preserve blinding.
16170879|NCT01617187|Drug|Asenapine|2.5 mg or 5 mg fast dissolving active asenapine tablets administered sublingually
16170880|NCT01617187|Drug|Placebo Asenapine|Fast dissolving placebo asenapine tablets (to match 2.5 mg and 5 mg active asenapine tablets) administered sublingually
16170881|NCT01617187|Drug|Olanzapine|5 and 10 mg film-coated active olanzapine tablets administered orally QD. The time of the active olanzapine dose (either morning or evening) is not disclosed in order to preserve blinding
16170882|NCT01617187|Drug|Placebo Olanzapine|Film-coated placebo olanzapine tablets (to match 5 and 10 mg active olanzapine tablets) administered orally
16170883|NCT01617174|Behavioral|Webcore telephone survey system|Patients will report pain and analgesic use through the automated telephone system, for 7 days in a row, once every 6 weeks. Data from diagnostic tests (CT Abdomen/Pelvis, Bone Scan, PSA, and circulating tumor cells) conducted during the study period will be collected from medical records by local personnel and entered into the secure online database quarterly, but no specific tests or schedules will be required in this observational study.
16170884|NCT01617161|Radiation|Proton Beam Therapy|5 days per week up to 9 weeks
16170885|NCT01617161|Radiation|Intensity Modulated Radiation Therapy|5 times per week up to 9 weeks
16170886|NCT01617148|Drug|Aflibercept|Patients received 2 mg (0.05 mL) of intravitreal aflibercept injection administered monthly for the first 3 months, followed by 2 mg (0.05 mL) once every 2 months as per the drug label for the next 9 months.
16170887|NCT01617135|Drug|CVT-301|
16170888|NCT01617135|Drug|Placebo|
16170889|NCT01617135|Drug|Sinemet (carbidopa/levodopa)|
16170890|NCT01617135|Drug|CVT-301|
16170891|NCT01617122|Biological|Bacteriophage OX174|Give first dose of bacteriophage (2 x 109 PFU/kg body weight (0.02 ml/kg)) at visit one. Obtain labs prior to vaccine, 15 minutes, 1 week, 2 weeks, and 4 weeks after vaccine. 6 weeks after 1st vaccine, obtain blood, give 2nd dose of bacteriophage, obtain labs 15 minutes, 1 week, 2 weeks, and 4 weeks after vaccine. Selected patients may receive a tertiary vaccine.
16170892|NCT01617109|Dietary Supplement|Ca/Vit D|800IU vitamin D3 and 2000mg elemental calcium (as calcium carbonate); administered as 5 pills daily or 2 snack bars
16170893|NCT01617109|Other|Placebo|administered as 5 pills daily or as 2 snack bars
16170894|NCT01617096|Combination Product|Dapivirine Vaginal Ring|Dosage form: vaginal ring Dosage: 25mg Frequency: monthly Duration: 12 months
16170895|NCT01617096|Combination Product|Placebo Ring|Vaginal ring containing no drug substance
16170896|NCT01617083|Drug|Azithromycin|Antibiotic used to treat infections
16170897|NCT01617083|Drug|Placebo|Thickening compound with sugar and flavoring
16170898|NCT01617070|Drug|Kuvan|Dosed at 20 mg/kg; PO; Phase 3, Phase 4
16170899|NCT01617070|Dietary Supplement|Large Neutral Amino Acid Therapy|Dosed by weight: weight x .5 = total tablets per day; PO; Phase 1, Phase 4; taken with food
16170900|NCT01617057|Drug|tiludronic acid|400 mg / day for 3 months
16170901|NCT01617057|Drug|Placebo|400 mg / day for 3 month
16170902|NCT01617044|Dietary Supplement|Probiotics|probiotics lactobacillus plantarum 299 (1x10x8 colony forming units)
16170903|NCT01617044|Dietary Supplement|Placebo|Placebo
16170904|NCT01617005|Drug|Tocilizumab|Participants will receive tocilizumab treatment according to effective official SPC. The study protocol does not enforce treatment initiation and also does not specify any treatment regimen.
16170905|NCT01616992|Drug|Bupivacaine|20 ML dose of 0.75% Bupivacaine Instillation (into bladder) 1 time during second study visit.
16170906|NCT01616979|Procedure|placing saline bag during cardiac displacement|For grafting to LCX territory, the heart is displaced using positioner and a suction-type epicardial stabiliser is applied to the target area. The degree of cardiac displacement and the LV compression by stabilisers are adjusted for maximal surgical access and minimal haemodynamic instability.
16170907|NCT01616966|Drug|Sevoflurane|Maintenance of anesthesia with sevoflurane 1.0 Vol%
16170908|NCT01616966|Drug|propofol|Maintenance of anesthesia with propofol
16170909|NCT01616953|Biological|Ixmyelocel-T|Twelve days after the bone marrow aspiration, alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with the cell therapy (Ixmyelocel-T)
16170910|NCT01616953|Procedure|Autogenous Bone Grafting|Alveolar grafting will be performed. Under local anesthesia, and possibly conscious intravenous sedation (depending on patient desire for sedation due to anxiety), alveolar grafting will be performed with an autogenous bone block harvested from an intraoral or extraoral site, according to standard of care.
16170911|NCT01616940|Behavioral|Enhanced Peer Intervention|"Eight 30-60 minute educational sessions with peer will occur in-person bi-weekly once participant is randomized to intervention:
~Introduction and Assessment
~HIV Transmission & Viral Life Cycle
~Effective Communication and Self-Advocacy
~Understanding Lab Values
~HIV Medications
~Drug Resistance & Adherence, and Understanding & Managing Side Effects
~Disclosure and Stigma
~Harm & Risk Reduction
~Weekly check-ins will be by phone or in-person over 12 months. Check-in questions/tasks:
~Are any services needed?
~Have referrals or appointments been made?
~Does patient need accompaniment to a visit?
~Connect patient with services as needed.
~Appointment reminders.
~Overall well-being?
~Schedule next peer contact."
16170912|NCT01616927|Drug|Lanreotide|Lanreotide will be administered once every 4 weeks as a subcutaneous injection
16170913|NCT01616901|Procedure|Spontaneous breathing trial|"5 spontaneous breathing trial will be tested by the patients in the same order :
~7 cm H2O continuous positive airway pressure
~T piece
~7 cmH2O of pressure support
~0 cmH20 of pressure support
~7 cm H2O pressure support ventilation with 7 cmH20 of end expiratory pressure."
16170914|NCT01616888|Device|PTA with drug eluting balloon with paclitaxel|Angioplasty with drug eluting balloon with paclitaxel on femoropopliteal arteries
16170915|NCT01616875|Drug|Cabazitaxel + Cisplatin chemotherapy|Cabazitaxel 15mg/m2 followed by cisplatin 70mg/m2 given intravenously on day 1 of each 3 weekly cycle for 4 cycles prior to radical cystectomy.
16170916|NCT01616849|Drug|cisplatin and 5-Fu combined with nimotuzumab|"DDP+5-Fu DDP 100 mg/m2 intravenous infusion in day1, 5-Fu 1000mg/m2/d continuous intravenous infusion on days 1 through 4, both drugs are given every 3 weeks.
~Nimotuzumab 200mg/d, intravenous infusion every week"
16170917|NCT01616836|Other|continuous FNB|femoral nerve block (ropivacaine 0.5%, 20 mL) with femoral nerve block infusion 48 h (ropivacaine 0.2%, 5mL/h), placebo local infiltration
16170918|NCT01616836|Other|single femoral nerve block|single femoral nerve block (ropivacaine 0.5%, 20 mL), placebo femoral nerve block infusion, placebo local infiltration
16170919|NCT01616836|Other|local infiltration analgesia|placebo fascia iliac block, placebo fascia iliaca infusion, local infiltration analgesia (tricompartmental injection of 150 mL ropivacaine 0.2%, ketorolac 30 mg, epinephrine 10 microg/mL)
16170920|NCT01616797|Behavioral|Computerized neurobehavioral intervention|Participants will complete the intervention by logging into a secure online website and complete computerized neurobehavioral tasks. Tasks will train the following - cognitive control, working memory and task shifting with two different tasks that engage these skills and positivity biases.
16170921|NCT01616784|Other|CSII (Insulin Pump) plus DAFNE|Medtronic MiniMed Paradigm Veo Insulin pumps (X54)
16170922|NCT01616784|Other|MDI (levemir® & quick acting insulin) plus DAFNE|Optimised MDI therapy using rapid and twice daily (Detemir/Levemir) long-acting insulin analogues
16170923|NCT01616771|Device|Macintosh laryngoscope|Glottis view assessment by direct visualization using Macintosh laryngoscope
16170924|NCT01616771|Device|GVL selected by weight|Glottis view assessment by GVL selected by weight which is usually selected first
16170925|NCT01616771|Device|smaller sized GVL|Glottis view assessment by GVL which is smaller in one size than GVL selected by age
16170926|NCT01616758|Drug|GTx-024 9mg|
16170927|NCT01616732|Drug|Testosterone|TU im
16170928|NCT01616732|Drug|placebo|placebo im
16170929|NCT01616719|Device|DTRAX Graft|DTRAX Graft is an allograft implant inserted to support spinal fusion.
16170930|NCT01616693|Dietary Supplement|Probiotic|A capsule that contains at least 1 x 10^9 Lactobacillus rhamnosus GG organisms per capsule. The contents of this capsule were given once daily orally.
16170931|NCT01616693|Dietary Supplement|Zinc|Zinc sulphate syrup is zinc sulphate heptahydrate (concentration 1mg/ml). 5 ml of this suspension was given once daily orally.
16170932|NCT01616693|Dietary Supplement|Probiotic placebo|The probiotic placebo was manufactured by the same company that manufactured the probiotic and contained inulin powder but no Lactobacillus rhamnosus GG. The contents of the capsule were given once daily orally.
16170933|NCT01616693|Dietary Supplement|Zinc placebo|The zinc placebo excluded the zinc sulphate but contained lactose and was diluted to match the taste. 5 ml of this suspension was given orally once daily.
16170934|NCT01616693|Biological|Rotavirus vaccine|1 ml Rotarix®, a lyophilized human rotavirus vaccine reconstituted with calcium carbonate buffer provided orally at 6 and 10 weeks.
16170935|NCT01616693|Biological|Oral polio vaccine|A liquid trivalent polio vaccine provided orally at 6 and 10 weeks.
16170936|NCT01616680|Drug|brentuximab vedotin|Given IV
16170937|NCT01616680|Other|laboratory biomarker analysis|Correlative studies
16170938|NCT01616680|Other|pharmacological study|Correlative studies
16170939|NCT01616667|Procedure|Total hip arthroplasty|The patients included is operated with a total hip arthroplasty due to primary osteoarthritis
16170940|NCT01616654|Drug|CD5789 25 µg/g cream|CD5789 25 µg/g cream applied once daily
16170941|NCT01616654|Drug|CD5789 50 µg/g cream|CD5789 50 µg/g cream applied once daily
16170942|NCT01616654|Drug|CD5789 100 µg/g cream|CD5789 100 µg/g cream applied once daily
16170943|NCT01616654|Drug|Tazarotene 0.1% gel|Tazarotene 0.1% gel applied once daily
16170944|NCT01616654|Drug|Vehicle cream|Vehicle cream applied once daily
16170945|NCT01616628|Behavioral|Fruit and vegetable rewards|Participants earn reward points at 50% the rate of how much they spend on fruit and vegetables. The earned reward points are distributed as money added to gift cards to be redeemed at the market.
16170946|NCT01616615|Drug|Aspirin|150 mg/day oral use
16170947|NCT01616615|Drug|placebo|1 capsule / day oral use
16170948|NCT01616602|Other|Prone Position|Patients were asked to lay on their abdomen for their elective colonoscopy.
16170949|NCT01616602|Other|Standard Position|The traditional left-lateral decubitus position
16170950|NCT01616576|Device|Control first, then Experimental|Control condition is currently marketed sound processing strategy.
16170951|NCT01616576|Device|Experimental first, then Control|Experimental condition is newly modified sound processing strategy.
16170952|NCT01616563|Behavioral|Dietary Intervention|Nutrition assessment, review of the basic principles of dietary intervention for metabolic syndrome with an emphasis on the clinical risk factors identified for each individual, joint goal setting to determine what dietary changes are feasible, considering intention and barriers to dietary behaviour change.
16170953|NCT01616563|Behavioral|Exercise Prescription and Fitness Program|Exercise tests (aerobic fitness, muscular and flexibility tests) recommended by the Canadian Society of Exercise Physiology (CSEP), followed by an individualized exercise plan including fitness assessments.
16170954|NCT01616550|Other|Assessment of pain using the Brief Pain Questionnaire|Patients will complete this questionnaire daily from surgery until discharge from the hospital
16170955|NCT01616550|Other|Assessment of pain relief using a Verbal Numeric Scale (VNS)|Patients will assess their pain daily from surgery until discharge from the hospital using the VNS
16170956|NCT01616550|Other|Assessment of patient' satisfaction with pain relief|Will be assessed three times a day using a scale from 1 to 4 (1= very unsatisfied, 4= very satisfied)
16170957|NCT01616550|Other|Nurse's satisfaction with patient's pain relief and recovery|Will be assessed three times a day using a scale from 1 to 4 (1= very unsatisfied, 4= very satisfied)
16170958|NCT01616537|Other|QUALITY OF LIFE QUESTIONNAIRE|QASICC AND EORTC QLQ-C30 ADMINISTRATION 30 DAYS AFTER CVC IMPLANTATION
16170959|NCT01616524|Biological|Pegylated interferon lambda (pegIFNλ)|Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks
16170960|NCT01616524|Biological|Pegylated interferon lambda (pegIFNλ)|Syringe, Subcutaneous, 180 μg, Once weekly, 12 weeks
16170961|NCT01616524|Biological|Pegylated interferon alfa-2a (pegIFNα-2a)|Syringe, Subcutaneous, 180 μg, Once weekly, 24 weeks
16170962|NCT01616524|Drug|Ribavirin|Tablets, Oral, 400 mg, Twice daily, 24 weeks
16170963|NCT01616524|Drug|Ribavirin|Tablets, Oral, 400 mg, Twice daily, 12 weeks
16170964|NCT01616524|Drug|Daclatasvir|Tablets, Oral, 60 mg, Once daily, 12 weeks
16170965|NCT01616524|Drug|Placebo matching Daclatasvir|Tablets, Oral, 0 mg, Once daily, 12 weeks
16170966|NCT01616485|Drug|TA-1790|2 TA-1790 100 mg capsules
16170967|NCT01616485|Drug|Sildenafil citrate|2 sildenafil citrate 50 mg capsules
16170968|NCT01616485|Drug|Placebo|2 placebo capsules for TA-1790 100 mg capsules
16170970|NCT01616472|Drug|Cumulative corticosteroid exposure|Cumulative steroid exposure will be modeled as cumulative dose (prednisone equivalent mg), cumulative days of exposure at any dose, cumulative days of exposure to doses ≥7.5mg and cumulative days of exposure to doses ≥20mg.
16170971|NCT01616459|Biological|Pneumococcal conjugate vaccine GSK2830929A|Intramuscular injection
16170972|NCT01616459|Biological|Pneumococcal conjugate vaccine GSK2830930A|Intramuscular injection
16170973|NCT01616459|Biological|Synflorix™|Intramuscular injection
16170974|NCT01616459|Biological|Prevnar 13™|Intramuscular injection
16170975|NCT01616459|Biological|Infanrix hexa™|Intramuscular injection
16170976|NCT01616433|Behavioral|AFEP|Arthritis Foundation Exercise Program (10 weeks, twice a week, 60 minutes per session)
16170977|NCT01616433|Behavioral|"10 Keys to Healthy Aging"|"10 Keys to Healthy Aging. 10 week program, twice a week, 75 minutes per session."
16170978|NCT01616420|Other|Assisted-partner notification services|Assisted-partner notification services (aPS) is a public health service which notifies the partners of those who test positive for a communicable disease of their exposure.
16170979|NCT01616407|Drug|3,4-Methylenedioxymethamphetamine|75 mg per os, single dose
16170980|NCT01616407|Drug|Methylphenidate|40 mg per os, single dose
16170981|NCT01616407|Drug|Placebo|capsules identical to MDMA or methylphenidate but containing no active drug
16170982|NCT01616381|Drug|Sildenafil|PDE-5 Inhibitor
16170983|NCT01616381|Drug|Placebo|Placebo for sildenafil 40mg x 3 daily
16170984|NCT01616368|Behavioral|Mindful Eating and Living Course|An eight week course designed to teach mindfulness skills with an emphasis on mindful eating.
16170985|NCT01616355|Other|Sodium hypochlorite immersion|Dentures daily immersion in a 0.5% sodium hypochlorite solution for 3 minutes.
16170986|NCT01616342|Device|Spinal cord stimulator|Precise (TM) spinal cord stimulator from boston scientific, and comprehensive mdedical management.
16170987|NCT01616316|Procedure|subfascial flap|subfacial dissection to thyroid
16170988|NCT01616316|Procedure|subplatysmal flap|subplatysmal approach to thyroid
16170989|NCT01616303|Drug|Carboplatin|carboplatin (area under the curve (AUC) 6, administered intravenously in a single day for 6 cycles every three weeks [21 days])
16170990|NCT01616303|Drug|Paclitaxel|Paclitaxel (175 mg / square meter, intravenously over three hours in one day to be repeated for 6 cycles every three weeks [21 days])
16170991|NCT01616303|Biological|oregovomab|oregovomab (2 mg infused intravenously jointly during the 1st, 3rd and 5th chemotherapy cycle and 12 weeks after the 5th cycle).
16170992|NCT01616290|Drug|PRT-201|0.03, 1, or 3 mg single adventitial administration
16170993|NCT01616277|Biological|PF-06252616|1.0 milligram per kilogram of PF-06252616, IV infusion, single dose
16170994|NCT01616277|Drug|Placebo|Placebo for PF-06252616, IV infusion, single dose
16170995|NCT01616277|Biological|PF-06252616|3.0 milligram per kilogram of PF-06252616, IV infusion, single dose
16170996|NCT01616277|Drug|Placebo|Placebo for PF-06252616, IV infusion, single dose
16170997|NCT01616277|Biological|PF-06252161|10.0 milligram per kilogram of PF-06252616, IV infusion, single dose
16170998|NCT01616277|Drug|Placebo|Placebo for PF-06252616, IV infusion, single dose
16170999|NCT01616277|Biological|PF-06252616|3.0 milligram per kilogram of PF-06252616, Subcutaneous injection, single dose
16171000|NCT01616277|Drug|Placebo|Placebo for PF-06252616, Subcutaneous injection, single dose
16171001|NCT01616277|Biological|PF-06252616|10.0 miligram per kilogram of PF-06252616, IV infusion, repeat dose
16171002|NCT01616277|Drug|Placebo|Placebo for PF-06252616, IV infusion, repeat dose
16171003|NCT01616277|Biological|PF-06252616|20.0 milligram per kilogram of PF-06252616, IV infusion, single dose
16171004|NCT01616277|Drug|Placebo|Placebo for PF-06252616, IV infusion, single dose
16171005|NCT01616277|Biological|PF-06252616|40.0 milligram per kilogram of PF-06252616, IV infusion, single dose
16171006|NCT01616277|Drug|Placebo|Placebo for PF-06252616, IV infusion, single dose
16171007|NCT01616251|Other|Acute effect of animal and vegetable protein rich meals with comparable dietary fibers content on appetite sensation and energy intake|4-arm crossover study with the objective to examine if vegetable protein (beans and peas) can suppress subjective appetite (VAS and ad libitum EI) compared to isocaloric meals enriched with either red meat or egg with similar distribution of macronutrients and content of dietary fibers.
16171008|NCT01616238|Drug|Chemotherapy|Treatment for all pathways consists of Induction, Intensification (where applicable), Consolidation and Maintenance therapy during which combination chemotherapy is given for up to 2.5 years.
16171009|NCT01616225|Drug|Saizen (Human Growth Hormone)|Subjects will receive the standard protocol treatment, as well as adjuvant GH. One 3.33 mg vial Human Growth Hormone(10 IU Saizen®) will be self-administered daily by subcutaneous injection. GH treatment will start 14 days before FSH start and will continue until the day of the HCG treatment.
16171010|NCT01616225|Drug|Saizen (Human Growth Hormone)|Subjects will receive the standard IVF treatment, as well as adjuvant GH as above. One 3.33 mg vial Human Growth Hormone(10 IU Saizen®) will be self-administered daily by subcutaneous injection. GH treatment will start on the same day as the FSH start and will continue until the day of HCG treatment.
16171011|NCT01616225|Drug|No Saizen Control (Standard IVF Protocol)|All patients will be administered an oral contraceptive (Marvelon®). FSH treatment (daily subcutaneous injections of 450 IU Gonal-F®; Serono Canada) must begin 4 days after OCP stop, providing both of the following criteria are met. Pituitary downregulation with GnRH antagonist (Cetrotide®, Serono Canada) 0.25mg daily (subcutaneous injection) and LH (Luveris®, Serono Canada) 75 IU daily (subcutaneous injection) will be initiated when one or both of the following criteria are satisfied. Monitoring will continue until a lead follicle reaches ≥18 mm, at which time HCG (Ovidrel®, Serono Canada) 250 mcg will be administered by subcutaneous injection. Oocytes will be retrieved 36 hours after HCG treatment. Luteal support for the endometrium (90 mg progesterone (8% progesterone gel; Crinone® gel), administered intravaginally once daily) will begin one day after oocyte retrieval and will be maintained at least until day 31 of gestation.
16171012|NCT01616212|Other|Motivational Enhancement Therapy /Adol and PW for parents|Motivational Enhancement Therapy for adolescents, Parenting Wisely for parents
16171013|NCT01616212|Other|Motivational Enhancement Therapy for adolescents|Motivational Enhancement Therapy for adolescents
16171014|NCT01616212|Other|Drug Education for adolescents, Parenting Wisely for parents|Drug Education for adolescents, Parenting Wisely for parents
16171015|NCT01616212|Other|Drug Education for adolescents|Drug Education for adolescents
16171016|NCT01616199|Drug|PX-866|"Phase 1 dose escalation: PX-866 in combination administered orally every day in 28-day cycles until progression or unacceptable toxicity.
~Phase 2 combination: PX-866 and vemurafenib administered every day in 28 day cycles until progression or unacceptable toxicity.
~Phase 2 single-agent: vemurafenib administered orally at labeled dose every day in 28 day cycles until progression or unacceptable toxicity."
16171017|NCT01616199|Drug|vemurafenib|vemurafenib is a B-Raf enzyme inhibitor
16171018|NCT01616186|Drug|Everolimus and sorafenib|"Starting doses: everolimus 5 mg daily and sorafenib 400 mg BID - taken fasting, no food 1 hour before or 2 hours after dosing
~Everolimus and sorafenib are dosed continuously
~(Note: everolimus and sorafenib are typically dosed in 28 day cycles, and sunitinib is typically dosed in 42 day cycles; for the purposes of this protocol to keep timing consistent, a cycle will be defined as 42 days of therapy)"
16171019|NCT01616186|Drug|Sunitinib monotherapy|"Starting dose: sunitinib 50 mg daily 4 weeks on, 2 weeks off - taken fasting, no food 1 hour before or 2 hours after dosing
~(Note: sunitinib is typically dosed in 42 day cycles described above: 28 days treatment, 14 days off. For the purposes of this protocol, to keep timing consistent, a cycle will be defined as 42 days of therapy)"
16171020|NCT01616173|Drug|Dexamethasone|IV dexamethsone 8mg in 50mL (diluted in NS)
16171021|NCT01616173|Drug|Dexamethasone|8mg/2mL
16171022|NCT01616173|Drug|Saline|2mL
16171023|NCT01616160|Drug|mometasone furoate|2 sprays/nostril BID
16171024|NCT01616147|Behavioral|Intensive Lifestyle Intervention (ILI)|Women in the ILI arm will receive intensive counseling during pregnancy and group counseling after delivery regarding behavior, nutrition, and physical activity change. Visits to counselors will occur twice monthly with additional weekly telephone and internet contacts.
16171025|NCT01616147|Behavioral|Usual Care|Women in the usual care group will be offered group support classes approximately every 2 months during pregnancy and 3 months after pregnancy.
16171026|NCT01616134|Other|Korea red ginseng|Intervention group were administered with 4 capsules (2 g) each of powdered red ginseng (6-year old , rootlets) 40 minutes before breakfast, lunch and dinner, totaling 12 capsules (6 g) per day, for 12 weeks
16171027|NCT01616134|Other|Placebo|The subjects in the Control group were given the same quantity of placebos also three times a day for 12 weeks.
16171028|NCT01616121|Other|Usual treatment of patients with developing acute heart failure|
16171029|NCT01616121|Device|Lung Impedance-Guided Therapy|Non-invasive lung impedance monitor (RSMM Company, Tel Aviv, Israel)
16171030|NCT01616108|Drug|Bupivacaine|Differences in concentration from 0.75% to 3.0% are compared. Differences in volume for 1.0 mL to 3.0 mL are compared. Differences in compounding with addition of epinephrine will be used and compared to plain bupivacaine.
16171031|NCT01616082|Behavioral|Low Calorie Diet (LCD)|A Diet History Questionnaire was completed and subjects had dietary counseling and were provided shakes. The low calorie diet began, to continued for a period of 8 weeks.
16171032|NCT01616082|Drug|Phentermine|"Individuals not on track to achieve their target weight by four weeks received the drug Phentermine to promote weight loss. Then, following eight weeks LCD (or four weeks LCD + four weeks LCD+Phentermine), in the event that they did not achieve the target weight loss, subjects were given the option to continue with the LCD + Phentermine for up to an additional 12 weeks, under a doctor's supervision.
~Protection Against Risk:
~Prior to administering any phentermine, a history and physical including EKG will be conducted (at the screening visit) and will be used to determine whether the participant is clear to receive the medication.
~Participants will see the study doctor or nurse practitioner at every study visit after the drug is initiated."
16171033|NCT01616069|Drug|epinephrine and levosimendan|epinephrine (0,06mcg/kg/min), levosimendan (0,2 mcg/kg/min)
16171034|NCT01616056|Biological|graft versus host disease prophylaxis/therapy|Wear bandage lenses
16171035|NCT01616056|Other|questionnaire administration|Ancillary studies
16171036|NCT01616056|Procedure|optical coherence tomography|Optional ancillary studies
16171037|NCT01616043|Procedure|Glyaderm|acellular dermis
16171038|NCT01616043|Procedure|STSG|autologous split skin only
16171039|NCT01616030|Other|Knee-extension strength training of the fractured limb|Daily knee-extension strength training with 3 x 10 repetitions using an intensity of 10 Repetition Maximum (RM) for the hip fractured limb started as soon as possible after surgery.
16171040|NCT01616004|Drug|N2O|
16171041|NCT01616004|Drug|Air|sham comparator
16171042|NCT01615991|Drug|Radiosynoviorthesis|Intraarticular administration from 111 to 222 Mbq yttrium-90 per joint
16171043|NCT01615978|Drug|liraglutide|5 mcg/kg daily for 14 days. Injected subcutaneously once daily
16171044|NCT01615978|Drug|liraglutide|Initial dose of 5 mcg/kg for 7 days followed by 10 mcg/kg for 7 days. Injected subcutaneously once daily
16171045|NCT01615978|Drug|placebo|Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1
16171046|NCT01615965|Other|tumor marker detection in lymph nodes|tumor marker detection in lymph nodes by quantitative PCR
16171047|NCT01615939|Drug|Bupivacaine|Bupivacaine 0.625% with epinephrine 1:300,000
16171048|NCT01615939|Drug|Ropivacaine|0.2% ropivacaine 5 ml/hr with a 5 ml bolus/hr.
16171049|NCT01615913|Drug|3 mg terbinafine and 2 mg ketoconazole containing patch|A novel transdermal patch that is to be used to treat toenail onychomycosis with minimal body exposure to the antifungal drugs. The active substances in the patch are 3% terbinafine (contains 3-mg terbinafine/patch) and 2% ketoconazole (contains 2-mg ketoconazole/patch). The average daily released drug amount estimated from in-vitro skin permeation test were about 3.99 mcg for terbinafine and 1.70 mcg for ketoconazole, respectively.
16171050|NCT01615913|Drug|6 mg terbinafine and 2 mg ketoconazole containing patch|A novel transdermal patch that is to be used to treat toenail onychomycosis with minimal body exposure to the antifungal drugs. The active substances in the patch are 6% terbinafine (contains 6-mg terbinafine/patch) and 2% ketoconazole (contains 2-mg ketoconazole/patch). The average daily released drug amount estimated from in-vitro skin permeation test were about 8.52 mcg for terbinafine and 2.03 mcg for ketoconazole, respectively.
16171090|NCT01615627|Drug|HypotonicTreprostinil Solution|Hypotonic Treprostinil Solution
16171091|NCT01615627|Drug|Eutonic Treprostinil Solution|Eutonic Treprostinil Solution
16171051|NCT01615913|Drug|8 mg terbinafine and 2 mg ketoconazole containing patch|A novel transdermal patch that is to be used to treat toenail onychomycosis with minimal body exposure to the antifungal drugs. The active substances in the patch are 8% terbinafine (contains 8-mg terbinafine/patch) and 2% ketoconazole (contains 2-mg ketoconazole/patch). The average daily released drug amount estimated from in-vitro skin permeation test were about 10.7 mcg for terbinafine and 2.17 mcg for ketoconazole, respectively.
16171052|NCT01615900|Other|Teleconsultation / Standard consultation|"Stage 1: randomization. Two arms: teleconsultation and standard consultation
~Stage 2: calculation of Kidney Transplant Failure Score which will determine 4 sub-groups: teleconsultation high risk, teleconsultation low risk, standard consultation high risk and standard consultation low risk.
~Stage 3: follow-up (2 years) according to the group:
~Standard consultation low risk: consultation every 2 months during one year and then every 3 months during one year
~Standard consultation high risk: consultation every 6 weeks during one year and then every 2 months during one year
~Teleconsultation low risk: same follow-up as standard consultation low risk group but all the consultations are teleconsultations
~Teleconsultation high risk: same follow-up as standard consultation high risk group but the follow-up will be intensified by the addition of an intermediate teleconsultation (between 2 consultations)"
16171053|NCT01615887|Drug|lisdexamfetamine sulfate|30mg lisdexamfetamine OD, increased to 70mg OD over 4 weeks and continued on 70mg OD for 4 weeks
16171054|NCT01615887|Drug|placebo|sugar pill
16171055|NCT01615874|Drug|MF/F Metered Dose Inhaler (MDI) 25/5 mcg|MF/F MDI 25/5 mcg, 2 inhalations twice a day (BID)
16171056|NCT01615874|Drug|MF/F MDI 50/5 mcg|MF/F MDI 50/5 mcg, 2 inhalations BID
16171057|NCT01615874|Drug|MF/F MDI 100/5 mcg|MF/F MDI 100/5 mcg, 2 inhalations BID
16171058|NCT01615874|Drug|BDP hydrofluoroalkane (HFA) 80 mcg|BDP HFA 80 mcg, 2 inhalations BID
16171059|NCT01615874|Drug|Montelukast tablets 5 mg (4 mg for children 5 years of age)|"Montelukast chewable tablets 5 mg once daily (QD) for children 6-11 years of age
~OR
~Montelukast chewable tablets 4 mg QD for children 5 years of age"
16171060|NCT01615874|Drug|Rescue medication: short-acting beta-2 agonist (SABA) MDI|albuterol MDI 90 mcg OR or salbutamol HFA MDI 100 mcg for rescue medication, taken as directed
16171061|NCT01615874|Drug|Rescue medication: Prednisone/Prednisolone|Prednisone/Prednisolone for rescue medication, taken as directed
16171062|NCT01615861|Procedure|IOL implantation|Micro-incision phacoemulsification cataract surgery (C-MICS) and IOL implantation with 1.8mm cartridge tip insertion technique.
16171063|NCT01615861|Device|IOL Implantation|Micro-incision phacoemulsification cataract surgery (B-MICS) and IOL implantation with 1.4mm wound-assist insertion technique.
16171064|NCT01615848|Other|mediterranean diet restricted calorie|1500 k/cal 30% fat
16171065|NCT01615848|Other|high protein diet|50 pcos diagnosed women will be assigned to high protein diet for 18 month
16171066|NCT01615848|Other|mediterranean diet restricted calorie|50 pcos women will be assigned to 1500 k/cal diet for 18 month
16171067|NCT01615835|Other|EnSite NavX System|EnSite NavX system is a 3D Mapping system
16171068|NCT01615822|Drug|OZ439 100mg|OZ439 100mg oral suspension, single dose
16171069|NCT01615822|Drug|OZ439 400mg|OZ439 400mg oral suspension, single dose
16171070|NCT01615822|Drug|MQ 250 mg, single dose|Mefloquine 250 mg tablet, single dose
16171071|NCT01615822|Drug|MQ 750mg, single dose|Mefloquine 750mg oral tablet, single dose
16171072|NCT01615822|Drug|Placebo|
16171073|NCT01615809|Drug|AMPHOTERICIN B|The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.
16171074|NCT01615796|Drug|Part A: GSK2140944 Drug single dose of 200mg, 600mg, 1200mg, 1800 mg, and dose to be determined|Subjects receive a single dose of GSK2140944
16171075|NCT01615796|Drug|Part B: GSK2140944 Repeat Drug dose of 400mg, 750mg, 1000 mg, and dose to be determined|Subjects will receive repeat doses of GSK2140944 BID/TID for up to 14 Days
16171076|NCT01615783|Other|Subjects with COPD|Medicaid beneficiaries diagnosed with Chronic Obstructive Pulmonary Disease (COPD) and newly initiated on a maintenance medication
16171077|NCT01615783|Other|Subjects without COPD|Medicaid beneficiaries without a COPD diagnosis but having at least one medical or pharmacy claim during each year of the identification period
16171078|NCT01615770|Behavioral|cognitive behavior therapy|At each clinic session, staff met with participants individually for 30 minutes to develop cognitive and behavioral skills to resist urges to smoke. Staff used self-efficacy questionnaires to assess participants' confidence in their abilities to resist urges to smoke in specific situations and behavioral worksheets to help participants articulate treatment plans to be used in managing their behavior in these situations without smoking. Those participants randomized to extended CBT continued to work with treatment staff individually on the development and use of cognitive and behavioral cessation and relapse prevention skills. Treatment sessions, lasting approximately 30 minutes, were conducted at the San Jose clinic site at weeks 8, 12, 16 and 20.
16171079|NCT01615757|Drug|Ara-c|IV formulation, administered as a 2 hr infusion in 1 pint of normal saline, BD on D1,3,5 at 3 gm/m2 /dose
16171080|NCT01615757|Drug|Ara-c|IV formulation, administered as a 2 hr infusion in 1 pint of normal saline, BD on D1,3,5 at 2 gm/m2 /dose
16171081|NCT01615744|Procedure|Open Reduction Internal Fixation|Lateral approach through extensile lateral incision ( Benirschke), Reduction ( Soeur et Remy) and internal fixation with lateral plating with or without bone graft
16171082|NCT01615744|Procedure|Non-surgical management|Early active exercises and elevation to decrease swelling
16171083|NCT01615731|Drug|Mifepristone|200mg Mifepristone orally
16171084|NCT01615731|Other|Hygroscopic cervical dilators|Dilapan-S osmostic cervical dilators inserted through the internal os
16171085|NCT01615731|Drug|Misoprostol|400mcg buccal misoprostol 90 minutes pre-op
16171086|NCT01615731|Drug|Intra-amniotic digoxin|1mg digoxin administered intra-amniotically ~24 hours pre-op
16171087|NCT01615718|Procedure|low-intensity transcranial electrical stimulation|Subjects will undergo 20 minutes of low-intensity transcranial electrical stimulation of up to 2mA. During active stimulation, the current will be active for 20 minutes - however, during sham stimulation (placebo) the current will not be active for the full 20 minutes.
16171088|NCT01615718|Procedure|transcranial ultrasound|Subjects will undergo 20 minutes of transcranial ultrasound. During active stimulation, the ultrasound will be active for 20 minutes - however, during sham stimulation (placebo) the ultrasound will not be active for the full 20 minutes.
16171092|NCT01615614|Drug|Rilpivirine|Type=exact number, unit=mg, number=25, 50, and will be determined after treatment A and B analysis form=tablet, route=oral. Once or twice daily with a total daily dose of rilpivirine between 25 and 75 mg will be administered for 11 days.
16171093|NCT01615614|Drug|Rifabutin|Type=exact number, unit=mg, number=150, form=capsule, route=oral. Two capsules daily will be administered for 17 days.
16171094|NCT01615601|Drug|darunavir (PREZISTA)|Form = tablet, route = oral, Units = mg, number = 800 administered once daily
16171095|NCT01615601|Drug|etravirine (INTELENCE)|Form = tablet, route = oral, Unit = mg, number = 200, administered twice daily
16171096|NCT01615601|Drug|ritonavir|Form = tablet/capsule, route = oral, Units = mg, number = 100 administered once daily
16171097|NCT01615601|Drug|Other antiretroviral medications|Given as per Canadian Product Monograph
16171098|NCT01615588|Dietary Supplement|Manuka Honey|honey was weighed out to provide 25 g of available carbohydrate in 200 ml of water
16171099|NCT01615575|Procedure|Transanal haemorrhoidal dearterialisation|Closure of the arterial blood flow to the haemorrhoidal plexus, using a dedicated proctoscope with a Doppler probe, and a rectal mucopexy
16171100|NCT01615575|Procedure|Stapler haemorrhoidopexy|Haemorrhoidopexy with a single dedicated circular stapling device (PPH 03, Ethicon Endo-Surgery, Ohio, USA).
16171101|NCT01615549|Procedure|Laparsocopic cholecystectomy|Perform laparsocopic cholecystectomy on a virtual reality devise
16171102|NCT01615536|Procedure|Canine fossa trephine technique|Patients undergoing standard ESS and a canine fossa trephine technique, which is a 6 mm puncture in the anterior wall of the maxillary sinus, to allow standard sinus debrider blades and instruments to pass into the sinus to clear polyps in the maxillary sinus.
16171103|NCT01615536|Procedure|Standard Endoscopic Sinus Surgery|Patients undergoing standard ESS without canine fossa trephination with clearance of the maxillary sinus polyps via a wide maxillary antrostomy (WMA) with use of curved debrider surgical blades and instruments.
16171104|NCT01615523|Other|MRI, EEG and cognitive testing|Sleep EEG and one MRI, executive function testing using Strrop test, BRIEF questionnaire and CantabEclipse
16171105|NCT01615510|Drug|Tapentadol immediate release|100 mg, single administration
16171106|NCT01615510|Drug|placebo|placebo, single administration
16171107|NCT01615497|Behavioral|Standard Treatment as Usual (TAU)|Treatment normally offered at this clinic which could include individual or group alcohol and drug counseling sessions one time per week lasting one hour each time.
16171108|NCT01615497|Behavioral|Web-based CBT4CBT for alcohol plus TAU|Subjects work with a computerized program that teaches skills for stopping alcohol and drug use and increasing coping skills. Computerized sessions are one time per week and last about one hour per session. Plus TAU
16171109|NCT01615497|Behavioral|Web-based CBT with minimal clinical contact|Subjects work with a computerized program that teaches skills for stopping alcohol and drug use and increasing coping skills. Computerized sessions are one time per week and last about one hour per session. Plus 10 minute check in with clinician.
16171110|NCT01615484|Procedure|Transplantation of lungs obtained from Non-Heart-Beating Donors (NHBDs) after ex-vivo perfusion w/ STEEN Solution™|After EVLP, lungs will be cooled in the circuit to room temperature, then flushed with cold Perfadex™, and taken to UNCH where they will have an ex-vivo CT scan. Lungs determined suitable will be offered to consented patients at UNC Hospitals and Duke University Medical Center based on Lung Allocation Score. Lungs not considered for transplantation may be subjected to different experiments but are not to be a part of this research study. In summary, lungs with good and stable function during EVLP will be transplanted into recipients as per current clinical practice.
16171111|NCT01615484|Device|STEEN Solution™|This solution is a buffered dextran and albumin-containing extracellular perfusate with an optimal colloid osmotic pressure developed specifically for extra-corporeal perfusion of lungs.
16171112|NCT01615471|Behavioral|Group weight loss with companion internet|Monthly in-person group sessions with an companion internet weight loss intervention
16171113|NCT01615458|Behavioral|Chronic Care Model for Mood Disorders|CCM includes (1) patient self-management enhancement focused on promoting healthy lifestyles as coping strategies to minimize the negative impact of depressive, manic, and other affective symptoms; (2) provider support for evidence-based decision-making; and (3) enhanced access and continuity for anticipatory rather than reactive care.
16171114|NCT01615445|Drug|Resveratrol|Group A: resveratrol 1000 mg (500 mg twice) daily for 1 week then by tolerance and safety 2000 mg (1 000mg twice) daily for 3 weeks, followed by no medication for two weeks and then placebo for twice daily for 4 weeks.
16171115|NCT01615445|Drug|placebo|Participants will receive placebo daily for 4 weeks, followed by no medication for two weeks and then resveratrol 1 000 mg(500 mg twice) daily for 1 week, then by tolerance and safety 2 000 mg (1 000 mg twice) daily for three weeks.
16171116|NCT01615432|Device|V-PAP III ventilator|
16171117|NCT01615432|Device|Stellar 150 ventilator|
16171118|NCT01615432|Device|BiPAP vision ventilator|
16171119|NCT01615432|Device|V60 ventilator|
16171120|NCT01615406|Drug|99mTc MIP 1404|A single dose of 20 ±3 mCi intravenous (IV) injection of 99mTc MIP 1404
16171121|NCT01615393|Drug|ribavirin [Copegus]|Single oral dose of 400 mg tablets
16171122|NCT01615393|Drug|ribavirin [Vilona]|Single oral dose of a 400 mg capsule
16171123|NCT01615380|Behavioral|CBT+ Contact|In addition to the smoking cessation program, those in the CBT + CONTACT condition will enroll in a Wellness Program and will receive weekly wellness materials to read as well as receiving 4 sessions with a health educator in weeks 1, 4, 8 and 12 to discuss the wellness materials.
16171124|NCT01615380|Behavioral|CBT+ Exercise|Participants will receive an identical 12-week cognitive behavioral smoking cessation program delivered by YMCA staff and monitored by members of the research team to ensure fidelity of treatment delivery. In addition to the smoking cessation program, those in the CBT + EXERCISE condition will enroll in the 12-week YMCA Personal Fitness Program (PFP) where they will receive 4 sessions with a personal trainer in weeks 1, 4, 8 and 12 and will engage in aerobic exercise at least 3 times per week either in the PFP facilities or in other programs offered at the YMCA, such as aerobics classes.
16171125|NCT01615367|Other|Nutrition, Exercise, and Wellness (NEW) psychotherapy|NEW Tx is a flexible modular treatment such that modules are selected based on the needs of the individual to increase its generalizability across patients, settings, and providers as well as its acceptability to patients.
16171160|NCT01615107|Other|double balloonand oxytocin|balloonand oxytocin
16171126|NCT01615367|Drug|Typically consists of at least one FDA-approved mood stabilizer|Pharmacotherapy will be conducted by experts in BD treatment and will follow the empirically-supported treatment algorithm for BD that has been developed and recently revised. The foundation of TAU is to maintain treatment with at least one Food and Drug Administration approved mood stabilizer. For TAU, medication and dosage changes are allowed as needed as long as the change is recommended based on the guidelines and participants remain on a mood stabilizer.
16171127|NCT01615354|Drug|Aleglitazar|Multiple oral doses
16171128|NCT01615354|Drug|Microgynon®|Multiple oral doses
16171129|NCT01615354|Drug|Placebo|Multiple oral doses
16171130|NCT01615328|Device|Cervios ChronOs|The ACDF surgery will be carried out with Cervios ChronOs after randomization procedure.
16171131|NCT01615328|Device|Bonion|The ACDF surgery will be carried out with Bonion after randomization procedure.
16171132|NCT01615302|Procedure|Mucosa advancement flap|Mucosa advancement flap will be performed at the starting point of the fistula in the rectum
16171133|NCT01615302|Other|Platelet rich plasma (PRP)|"The PRP will be injected into the fistula, after the mucosa advancement flap was created.
~For the PRP we will need to take 55 millilitres of blood of the patient. This blood will be centrifuged into PRP."
16171134|NCT01615289|Dietary Supplement|Single intragastric instillation of 250 ml green tea extract|Intragastric instillation by feeding tube
16171135|NCT01615289|Dietary Supplement|Single intragastric instillation of 500 ml green tea extract|Intragastric instillation by feeding tube
16171136|NCT01615289|Dietary Supplement|Single intragastric instillation of 250 ml control solution|Intragastric instillation by feeding tube
16171137|NCT01615289|Dietary Supplement|Single intragastric instillation of 500 ml control solution|Intragastric instillation by feeding tube
16171138|NCT01615276|Device|Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES)|One our of one-legged neuromuscular electrical stimulation (NMES)
16171139|NCT01615276|Device|No Enraf Nonius Tensmed S84 for Neuromuscular electrical stimulation (NMES) NMES|No neuromuscular electrical stimulation (NMES) will be applied in the control leg
16171140|NCT01615263|Device|Lung isolation device|Lung isolation for one-lung ventilation with a left double lumen tube
16171141|NCT01615263|Device|Lung isolation device|Lung isolation for one-lung ventilation with a bronchial blocker inserted through a 8.0 mm simple lumen endotracheal tube
16171142|NCT01615250|Biological|Intramyocardial implantation of stem cells|Intramyocardial implantation of autologous peripheral mononuclear cells with CD34+ stem cells by NOGA.XP navigation system. Сell concentration is 200 million cells in 1 ml.
16171143|NCT01615237|Behavioral|Audit and performance feedback (PF)|Quarterly, trained clinic staff will use a standardized chart audit tool to evaluate documentation of cessation assistance. The feedback report will show individual and clinic performance summaries of two targeted provider behaviors based on documentation in the chart: 1) percentage of smokers advised to quit, and 2) percentage of smokers who received quitting assistance. Quitting assistance will be fulfilled by documentation of any of the following provider behaviors: a) Faxing a referral to the New York State (NYS) Quitline, b) Chart documentation of providing cessation counseling; and/or c) discussing and or prescribing cessation medications. Reports will be given to the Dental Director, who will be instructed to distribute them to dental providers no later than 30 days following the end of the quarter.
16171144|NCT01615237|Behavioral|Financial Incentive (P4P)|We will review charts of all smokers to evaluate documentation of cessation assistance (i.e., prescription given for cessation medication, the provision of brief cessation counseling and/or a fax referral to the NYS Quitline or other local cessation support program). Sites will receive $20 for each patient with chart documentation of receiving tobacco cessation assistance. The P4P reimbursement will be offered quarterly with an annual cap of $5000 to each site as employees are salaried.
16171145|NCT01615237|Behavioral|Current Best Practices (CBP)|CBPs that will be implemented is consistent with the PHS recommended guidelines and is as follows: The dental care team will assess smoking status, deliver advice to quit, assess readiness to quit, provide patient education materials, a prescription for cessation pharmacotherapy and referral to the NYS Quitline, and document findings and treatment plan on the chart system. In New York State, the Quitline provides free medication for uninsured. As brief provider interventions have been shown to be effective, the recommended tobacco treatment protocol will require approximately 5-10 minutes.
16171146|NCT01615224|Drug|misoprostol|repeated doses of misoprostol. 400mcg of oral misoprostol given at 3, 5, 7 and 9 hours.
16171147|NCT01615211|Drug|Letrozole|Day 1 Letrozole 2,5mg 3 tablets Day 2 Letrozole 2,5mg 3 tablets
16171148|NCT01615211|Drug|Trilostane|Day 1 Trilostane 120mg twice and Day 2 Trilostane 240mg twice
16171149|NCT01615198|Drug|Olmesartan|10 mg, 20 mg, 40 mg capsules
16171150|NCT01615198|Drug|Placebo|Matching placebo of LCZ696 tablet, matching placebo of Olmesartan capsule
16171151|NCT01615198|Drug|LCZ696|100 mg, 200 mg tablets
16171152|NCT01615185|Drug|full-dose amisulpride|amisulpride 800mg/d
16171153|NCT01615172|Procedure|cannulation|The different types of cannulation (aortic versus axillaris) were compared in the postoperative period for neurological deficits in three time periods.(intraoperative, 5.POD, 3 month POD)
16171154|NCT01615159|Behavioral|Behavior and lifestyle counseling|20 week intervention period where one group gets behavior and lifestyle counseling and the other group gets no active intervention
16171155|NCT01615146|Other|Platelet Transfusion|"Patients allocated to the therapeutic platelet transfusion group will not receive routine prophylactic platelet transfusions. Platelet transfusions will be given to treat documented clinically relevant bleeding defined as WHO bleeding of grade 2 or greater. Patients may be transfused at the discretion of the treating physician. The indication for all platelet transfusions will be recorded by asking the ordering physician.
~Patients allocated to the prophylactic platelet transfusions will receive a platelet transfusion when the measured platelet count is < 10 x 109/L. Patients may receive additional platelet transfusions at the discretion of the treating physician. The indication for all platelet transfusions will be recorded."
16171156|NCT01615120|Drug|GTx-758 125 mg|One 125 mg tablet once a day
16171157|NCT01615120|Drug|GTx-758 250 mg|two 125 mg tablets once daily
16171158|NCT01615107|Device|COOK RIPENENIG BALLOON+PITOCN|GROUP 2: insertion of the double balloon device and concurrent oxytocin administration.
16171159|NCT01615107|Drug|PITOCIN|: Oxytocin infusion alone (Standard Protocol
16171161|NCT01615107|Other|ballon and oxytocin|double- balloon catheter device with concurrent oxytocin
16171162|NCT01615107|Procedure|double balloonand and oxytocin|balloon catheter device with concurrent oxytocin
16171163|NCT01615081|Other|The acute effect of malt extract versus sucrose on the response of glucose and insulin, subjective appetite sensations and ad libitum energy intake|2-arm crossover study for investigation of the effect of malt extract vs. sucrose on glucose, insulin, subjective appetite sensations and ad libitum energy intake.
16171164|NCT01615055|Drug|Fluoxetine|20-40 mg fluoxetine po qd for 6 months
16171165|NCT01615055|Other|Placebo|20-40 mg pharmacologically inactive tablets for 6 months
16171166|NCT01615042|Drug|Lenalidomide|Oral capsule, daily, 50mg-100mg, one cycle (21 days)
16171171|NCT01615016|Other|Minimally invasive endotracheal surfactant application|"What are the planned trial interventions?
~MISurf: Minimally invasive intratracheal surfactant application without mechanical ventilation by feeding tube device
~InSurE: Surfactant application by InSurE strategy (Intubation - surfactant - extubation sequence).
~Both interventions will be performed by intervention teams. For the MISurf intervention, it was decided to use the minimally invasive method via feeding tube exclusively due to concerns about possibility of airway injury with the iv cannula device.
~Surfactant Two porcine derived surfactant products have been used in the published trials for minimal invasive surfactant application, Curosurf© and Survanta©. Due to safety reasons we will use these products also in our pilot study however, only the latter is currently available in Canada. Hence we will use Survanta© 100 mg/kgBW, equivalent to 4 ml/kgBW per dose.19,20,26"
16171172|NCT01615003|Drug|Xuesaitong soft capsule|Xuesaitong soft capsule, soft capsule, Ingredients:PNS, Specification:0.33 per bag, once take two pills and twice a day during a month.
16171173|NCT01615003|Drug|Xuesaitong soft capsule Placebo|Xuesaitong soft capsule Placebo, soft capsule, once take two pills and twice a day during a month.
16171174|NCT01614990|Drug|Macimorelin|Subjects will receive macimorelin (1 mg/kg) and matching placebo (Powerade®) daily for 7 days.
16171175|NCT01614990|Drug|Placebo|placebo (Powerade®) daily for 7 days.
16171176|NCT01614977|Drug|Methylprednisoline|Methylprednisolone (Danalone) 1mg/Kg/dose twice daily for 14 days followed by 1mg/Kg/dose in the morning once daily for 14 days,
16171177|NCT01614964|Drug|AQ-13 Treatment|Adult Malian males 18 years of age or older with uncomplicated P. falciparum malaria who agree to participate and provide their informed consent will be randomized to receive treatment with either AQ-13 or Coartem. Intervention 'AQ-13 Treatment' Participants randomized to the AQ-13 arm will be treated with two (350 mg) capsules on days 1 and 2 and one (350 mg) AQ-13 capsule on day 3 for a total oral dose of 1750 mg of AQ-13 (5 capsules containing 350 mg apiece) over 3 days.
16171178|NCT01614964|Drug|Coartem Treatment|Adult Malian males 18 years of age or older with uncomplicated P. falciparum malaria who agree to participate and provide their informed consent will be randomized to receive treatment with either AQ-13 or Coartem. Intervention 'Coartem Treatment' Participants randomized to the Coartem arm will receive six doses of Coartem tablets over 3 days (each dose containing 80 mg artemether and 480 mg lumefantrine). Those six doses will be given at the time of diagnosis and 8 hours later on day 1, at 24 and 36 hours on day 2 and at 48 and 60 hours on day 3 for total doses of 480 mg artemether and 2880 mg lumefantrine over 3 days.
16171179|NCT01614951|Procedure|Perfusion of the lungs|Pulmonary perfusion with oxygenated blood during ECC.
16171180|NCT01614951|Drug|HTK Custodiol|Pulmoplegia before ECC.
16171181|NCT01614951|Other|Standard ECC|ECC after standard procedure
16171182|NCT01614938|Drug|Cetuximab|400 mg/m2 initial dose before radiation, then 250 mg/m2 weekly during radiation
16171183|NCT01614938|Drug|Cisplatin|2 cycles of induction chemotherapy every 3 weeks with cisplatin 80 mg/m2 D1-3
16171184|NCT01614938|Drug|Docetaxel|2 cycles of induction chemotherapy every 3 weeks with docetaxel 75 mg/m2 D1
16171185|NCT01614938|Radiation|Intensity-modulated radiotherapy|a total dose of 66-70.4Gy in 30-32 fractions over 6-6.5 weeks planned to be delivered to the PTV of gross tumor
16171186|NCT01614938|Drug|Cisplatin|2 cycles of induction chemotherapy every 3 weeks with cisplatin 80 mg/m2 D1-3, then 6 cycles of concomitant chemotherapy every week with cisplatin 30 mg/m2 D1
16171187|NCT01614925|Device|Emdogain|Periodontal surgery with the additional use of Straumann® Emdogain
16171188|NCT01614925|Procedure|Periodontal surgery|Periodontal surgery alone
16171189|NCT01614912|Drug|SM-13496|40 or 80 mg once daily orally
16171190|NCT01614899|Drug|SM-13496 40mg|once daily orally
16171191|NCT01614899|Drug|SM-13496 80mg|once daily orally
16171192|NCT01614899|Drug|Placebo|once daily orally
16171193|NCT01614886|Drug|Active Comparator|1-step titration group begin treatment with a rivastigmine patch 9 mg/day for 4 weeks, followed by a dose increase to 18 mg/day.
16171194|NCT01614886|Drug|ENA713|-3-step titration group will begin treatment with a rivastigmine patch 4.5 mg/day for 4 weeks, followed by a further dose increase of 4.5 mg/day at 4-week intervals up to the maintenance dose of 18 mg/day.
16171195|NCT01614873|Device|Servo-i® ventilator, MAQUET,Critical Care, Sweden|Electrical activity of the diaphragm will be obtained through a naso-gastric tube with multiple array of electrodes placed at its distal end (Eadi catheter® , Maquet Critical Care, Sweden). Subject will be ventilated with a mouthpiece interface. NAVA will be compared to Pressure Support using the same ventilator. Once the pattern of breathing will be stabilized (10 minutes) in each condition (see arm) the following parameters will be recorded during 5 minutes and compared : tidal volume, inspiratory time, expiratory time, transcutaneous CO2 pressure, diaphragmatic Emg activity, delay between the inspiratory activity initiation and positive pressure initiation, delay between the end of the inspiratory effort and the end of pressurisation.
16171196|NCT01614847|Drug|Artificial tears|At random, subjects will receive isotonic artificial tear or a control (normal saline).
16171197|NCT01614821|Drug|PCI-32765|Taken orally, once daily in the morning
16171198|NCT01614808|Other|laboratory biomarker analysis|Correlative studies
16171199|NCT01614795|Biological|Cixutumumab|Given IV
16171200|NCT01614795|Other|Laboratory Biomarker Analysis|Correlative studies
16171201|NCT01614795|Drug|Temsirolimus|Given IV
16171202|NCT01614782|Drug|MK-5823|"MK-5823 administered subcutaneously (doses ranging from 0.35 mg to 2.8 mg) once daily for 3 weeks. Doses may be adjusted downward based on safety, tolerability, and/or pharmacokinetic data. The decision to dose escalate will be based on accrued safety/tolerability data at the prior dose level.
~In each arm, 6 participants will be randomized to receive study drug and 2 participants will be randomized to receive placebo."
16171203|NCT01614782|Other|Placebo|Matching placebo to MK-5823 administered subcutaneously once daily for 3 weeks.
16171204|NCT01614769|Drug|Placebo|Two gross-matched glimepiride placebo tablets taken on Day -1 and Day 1 of the three treatment periods.
16171205|NCT01614769|Drug|Glimepiride 2 mg|One placebo tablet and one 2-mg glimepiride tablet taken on Day -1 and Day 1 of the three treatment periods.
16171206|NCT01614769|Drug|Glimepiride 4 mg|Two 2-mg glimepiride tablets taken on Day -1 and Day 1 of the three treatment periods.
16171207|NCT01614769|Procedure|Hypoglycemic Clamp|On Day 1 of the three treatment periods, 180 minutes after drug treatment, a fixed-rate insulin infusion is combined with a variable-rate dextrose infusion to maintain plasma glucose concentrations at close to 50 mg/dL for 30 minutes.
16171208|NCT01614756|Biological|BMS-981164|
16171209|NCT01614756|Biological|Placebo matching with BMS-981164|
16171210|NCT01614743|Drug|IncobotulinumtoxinA|Experimental injection given at baseline and Week 16
16171211|NCT01614743|Drug|Bacteriostatic saline|Placebo at baseline, incobotulinumtoxinA at 16 weeks
16171212|NCT01614730|Device|Modified Neurotech Vital Device|verify no contraction is stimulated in the Modified Neurotech Vital.
16171213|NCT01614730|Device|Neurotech Vital Device|Checking there is a contraction of the pelvic floor muscle when the treatment is administered with the Neurotech Vital Device
16171214|NCT01614717|Device|CRT-P Implant|All patients will be implanted with a CRT-P device, then randomized to Treatment or Control Group
16171215|NCT01614691|Drug|SPARC1203|Active
16171216|NCT01614691|Drug|Placebo|Placebo
16171217|NCT01614678|Device|Lotrafilcon B contact lens with color, automated|Silicone hydrogel contact lens with color manufactured via an automated process
16171218|NCT01614678|Device|Lotrafilcon B contact lens with color, semi-automated|Silicone hydrogel contact lens with color manufactured via a semi-automated process
16171219|NCT01614665|Drug|Tacrolimus|Participants receive an initial total daily dose of tacrolimus depending on the type of organ transplant (heart = 0.075 mg/kg; liver/kidney = 0.3 mg/kg), to be given orally (or via nasogastric tube for liver transplant recipients) in 2 doses in the morning and the evening. The first dose is administered in the morning within days of skin closure (heart = 4 days; liver = 2 days; kidney = within 24 hours following reperfusion). Subsequent tacrolimus doses are taken orally twice a day in the morning and evening and are adjusted on the basis of clinical evidence of efficacy, occurrence of adverse events and observing the recommended whole blood trough level ranges (day 1 through 21 = 10 to 20 ng/mL; day 22 through 365 = 5 to 15 ng/mL).
16171220|NCT01614665|Drug|Tacrolimus prolonged release|Participants receive an initial total daily dose of tacrolimus prolonged release depending on the type of organ transplant (heart = 0.075 mg/kg; liver/kidney = 0.3 mg/kg), to be given orally (or via nasogastric tube for liver transplant recipients) in 1 dose. The first dose is administered in the morning within days of skin closure (heart = 4 days; liver = 2 days; kidney = within 24 hours following reperfusion). Subsequent tacrolimus prolonged release doses are taken orally once a day in the morning and are adjusted on the basis of clinical evidence of efficacy, occurrence of adverse events and observing the recommended whole blood trough level ranges (day 1 through 21 = 10 to 20 ng/mL; day 22 through 365 = 5 to 15 ng/mL).
16171221|NCT01614652|Device|CardioKinetix Parachute Implant and All Appropriate Medical Therapy (AAMT)|CardioKinetix Parachute implant and all appropriate medical therapy
16171222|NCT01614639|Procedure|Acupuncture|A licensed acupuncturist will perform acupuncture for two 30 minute sessions.
16171223|NCT01614613|Device|Bayer G3 / Tatsu System|Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
16171224|NCT01614613|Device|Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips|Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
16171225|NCT01614613|Device|Freestyle Lite® Meter and Test Strips with ZipwikTM tabs|Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
16171226|NCT01614613|Device|OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips|Study staff performed Blood Glucose (BG) tested with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
16171227|NCT01614613|Device|One Touch® VerioTM Pro/One Touch® VerioTM Test Strips|Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
16171228|NCT01614613|Device|Truetrack® Meter/Truetrack® Test Strips|Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
16171229|NCT01614600|Device|Nelfilcon A contact lenses|Commercially marketed hydrogel contact lenses for daily wear, daily disposable use
16171230|NCT01614574|Biological|velaglucerase alfa|60 U/kg every other week intravenous infusion
16171231|NCT01614535|Drug|up-and-down method to find out effective concentration of remifentanil for preventing cough during emergence|Targeted effect-site TCI remifentanil for preventing cough effectively during emergence from general anesthesia. For effect-site TCI of remifentanil, a TCI pump was used and pump operation was based on Minto and colleagues' pharmacokinetic model. By Dixon's up-and-down method, the predetermined effect-site concentration(Ce) of remifentanil was determined according to the cough response of the previous patient. The initial target Ce of remifentanil for the first patient was 2.0 ng/ml. If the patients did not cough throughout the peri-extubation period, the predetermined Ce of remifentanil for the subsequent patient was decreased by 0.4 ng/ml. If the patient coughed anytime around extubation, the predetermined Ce for the subsequent patient was increased by 0.4 ng/ml. The stopping rule, as well as for the requirement of at least six turning points in the same direction of the sequential allocation response graph, required the recruitment of more than 20 patients.
16171232|NCT01614522|Drug|ASLAN001|ASLAN001 500mg BID
16171233|NCT01614509|Procedure|intravitreal bevacizumab monotherapy|The monotherapy group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle.
16171234|NCT01614509|Procedure|combined therapy of posterior subtenon triamcinolone acetonide and intravitreal bevacizumab injection|The combined group receive intravitreal injection of 1.25 mg/0.05 ml bevacizumab and posterior subtenon injection of 40 mg/1.0 ml triamcinolone acetonide. The injections are performed using 0.5% proparacaine drops for topical anesthesia under sterile conditions. The bevacizumab is injected through the pars plana using a 30-gauge needle and triamcinolone acetonide is injected through the posterior subtenon area (near macula) by using a 27-gauge needle at the same time.
16171235|NCT01614496|Other|Algorithm for insulin administration|
16171236|NCT01614483|Other|Yellow cassava|Daily provision of 375 g boiled yellow cassava for 18 weeks, 6 days/week Daily provision of placebo capsule for 18 weeks, 6 days/week
16171237|NCT01614483|Other|White cassava|Daily provision of 375 g boiled white cassava for 18 weeks, 6 days/ week Daily provision of placebo capsule for 18 weeks, 6 days/ week
16171238|NCT01614483|Other|White cassava|Daily provision of 375 g boiled white cassava for 18 weeks, 6 days/week Daily provision of B-carotene capsule (1400 µg B-carotene)
16171239|NCT01614470|Drug|Ivacaftor|150 mg tablet, oral use, administered twice a day (q12h)
16171240|NCT01614470|Drug|Placebo|oral use, administered twice a day (q12h)
16171241|NCT01614457|Drug|Ivacaftor|Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks.
16171242|NCT01614457|Drug|Placebo|Placebo matched to Ivacaftor tablet orally twice daily for 24 weeks.
16171243|NCT01614444|Other|Active Acupressure Treatment|Participant will receive 8 active acupressure treatments.
16171244|NCT01614444|Other|Placebo Acupressure Treatment|Participants will receive 8 placebo acupressure treatments.
16171245|NCT01614431|Drug|N acetyl cysteine|N acetyl cysteine to cystinosis patients with CKD stages 1 to 4
16171246|NCT01614431|Drug|N acetyl cysteine|N acetyl cysteine for cystinosis patients CKD stages 1 to 4
16171247|NCT01614418|Device|Endoscopic radiofrequency ablation catheter|Endoscopic radiofrequency ablation
16171248|NCT01614405|Drug|Truvada and Kaletra|one tablet of Truvada a day at standard dose of Tenofovir 300mg and Emtricitabine 200mg and four tablets of Kaletra once a day for a total dose of lopinavir 800mg and ritonavir 200mg for 6 months or less if adverse events occur
16171249|NCT01614392|Behavioral|High velocity low force Power Training|Lower Extremity high velocity power training performed at lower external resistance (40% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions).
16171250|NCT01614392|Behavioral|Low velocity high force Power Training|Lower extremity low velocity power training performed at high external resistance (70% of the 1 repetition maximum muscle strength). Leg and knee extension exercises were performed twice per week (3 sets of each exercise consisting of 10 repetitions).
16171251|NCT01614366|Drug|AM 5 + DM 0|Amlodipine 5 mg + DMTA07 0mg, once daily
16171252|NCT01614366|Drug|AM 5 + DM 2.5|Amlodipine 5 mg + DMTA07 2.5mg, once daily
16171253|NCT01614366|Drug|AM 5 + DM 7.5|Amlodipine 5 mg + DMTA07 7.5mg, once daily
16171254|NCT01614366|Drug|AM 5 + DM 30|Amlodipine 5 mg + DMTA07 30mg, once daily
16171255|NCT01614353|Other|Electronic Diaries|Participants (N=30) will maintain electronic diaries to record spontaneous thoughts and perceptions regarding the use of a newly prescribed drug over 30 days.
16171256|NCT01614353|Other|Hermeneutic Interviews|Half of the enrolled participants (n=15) will participate in 2 hermeneutic interviews conducted in an interpretive phenomonological approach to generate an interpretation of the meaning of medication taking.
16171257|NCT01614340|Behavioral|Cognitive-Behavioral Pain Self-management Program|The main study intervention is training of the PTs on teams randomized into the intervention group in the evidence-based CBPSM program which has been translated for use in home health care with patients who have activity-limiting pain. The program is designed to be implemented in a manner that allows for maximal integration into routine PT care of home health patients. This will be possible because the CBPSM techniques, together with exercise and other PT techniques that constitute customary PT care, are reciprocally reinforcing. Both treatments (CBPSM and PT) encourage the use of similar behavioral and pain self-management coping skills to enhance behavioral activation, perceptions of self-efficacy, self-control, and personal mastery with regard to the management of pain.
16171258|NCT01614314|Other|Preceptorship|After attending a lecture and a video on the dressing of the tunneled central venous catheter, the subjects performed the procedure on a manikin simulator, with the aid of a nurse preceptorship, lasting one hour.
16171309|NCT01613950|Drug|BYL719|BYL719 is an oral α-specific phosphatidylinositol-3-kinase (PI3K) inhibitor.
16172409|NCT01604824|Drug|Placebo|SC injection in the abdomen
16171259|NCT01614314|Other|Auto-instructional guide|After attending a lecture and a video on the dressing of the tunneled central venous catheter, the subjects performed the procedure on a manikin simulator, with the aid of an auto-instructional guide, lasting one hour.
16171260|NCT01614301|Drug|dacarbazine (DTIC), Trofosfamide, Etoricoxib, Pioglitazone, Temsirolimus|"Dacarbazine (DTIC) 1000 mg/m2 day 1, every 3 weeks The total number of DTIC cycles should not exceed 6 cycles due to cumulative toxicity.
~Temsirolimus: 15 or 25 mg iv weekly , week 1+.In the phase I part of the study the finally used dosis will be determined. Pioglitazone (Actos) 60 mg p.o. daily, day 1+. Etoricoxib (Arcoxia) 60 mg p.o. daily, day 1+. Trofosfamide (Ixoten) 50 mg p.o. thrice daily as metronomic angiostatically and immunomodulatory actingtherapy, day 1+. Treatment until disease progression or toxicity"
16171261|NCT01614288|Procedure|knee Arthroscopy|Patient undergoes a knee arthroscopy and HTO
16171262|NCT01614288|Other|No arthroscopy|Patient undergoes an HTO without knee arthroscopy
16171263|NCT01614275|Behavioral|Technology-Enhanced Parent Training|"The training for the parents of children with autism assigned to the EIBI group will begin with completion of a structured parent-training program for 6 weeks that includes 16 to 18 sessions (three, 90-minute sessions per week). When a new topic is introduced, the initial training will include viewing a Power Point presentation, with embedded video and audio, that explains, in laymen's terms, the basic principles and processes related to the topic. The second part of the training involves a parent recruiting an adult friend, who will play the role of a child with autism. The adult playing the child with autism will wear a Bluetooth earpiece connected to a computer, which in turn will be connected to a UNMC expert. The expert will guide the actions of the adult playing the role of the child such that this confederate child will exhibit a variety of target behaviors relevant to the target skill, which will provide an opportunity for immediate feedback."
16171264|NCT01614275|Behavioral|Technology-Enhanced Tutor Training|"The training for the tutors to work with children diagnosed with autism, who were assigned to the EIBI group, will complete a 40-hour structured training program for 4 to 8 weeks that includes approximately 32 sessions. When a new topic is introduced, the initial training will include viewing a PowerPoint presentation, with embedded video and audio, that explains, in laymen's terms, the basic principles and processes related to the topic. The second part of the training involves a tutor recruiting an adult friend, who will play the role of a child with autism. The adult playing the child with autism will wear a Bluetooth earpiece connected to a computer, which in turn will be connected to a UNMC expert. The expert will guide the actions of the adult playing the role of the child such that this confederate child will exhibit a variety of target behaviors relevant to the target skill, which will provide an opportunity for immediate feedback."
16171265|NCT01614275|Behavioral|Technology-enhanced Early Intensive Behavioral Intervention|After training, the ABA tutor and parents will assist in the implementation of early intervention services that will be tailored to the particular needs of the family's child. These programs could include conducting a paired-stimulus preference assessment, using a natural language program to increase spoken communication, and using matching-to-sample methods to teach categorization skills. We will record and review at least an hour of the ABA tutor's and parents' interactions with the child per week during unstructured and structured teaching situations. The purpose of these observations is to determine whether the parents are implementing the teaching strategies or behavior-management programs as designed (i.e., treatment integrity measures). If the ABA tutor or parent implements a program with less than 80% accuracy across two consecutive observations, an additional scripted role-play will be conducted as a booster session for the targeted skills.
16171266|NCT01614275|Behavioral|No-Intervention|The ABA tutors, parents/caregivers, and children will be randomly assigned to a wait-list control group.
16171267|NCT01614262|Other|Continuous Glucose Monitoring with treatment algorithm|those subjects randomized to Continuous Glucose Monitoring results will be placed in CareLink iPro Clinical Management system, the experimental treatment guideline/algorithm has been programmed into the system. Providers will make treatment decisions based off of results of CGM.
16171268|NCT01614249|Dietary Supplement|Soybean oil soft gels|Each participant will receive OmegaVia soybean oil soft gels to take orally, one soft gel taken three times per day in the morning, mid-day and in the evening after meals for a period of 8 weeks
16171269|NCT01614249|Dietary Supplement|Fish oil omega-3 EPA-rich soft gels|A total of 3.0g of OmegaVia fish oil omega-3 EPA-rich soft gels will be taken orally per day as one soft gel in the morning, mid-day and evening after meals for 8 weeks with bi-weekly follow-up visits.
16171270|NCT01614236|Drug|pregabalin|Patients in one set (40 patients/sct) will received 150 mg of PGL or placebo at 20:00 the evening before surgery and 1.5 h before surgery and will undergo surgery under GA
16171271|NCT01614236|Drug|epidural|patients will be randomized similarly but will undergo surgery under epidural analgesia
16171272|NCT01614223|Procedure|ACP|Within two weeks of the initial visit, the RN, will retrieve a 10-12 mL blood sample from all patients. After the sample is retrieved, the patient will be asked to lie prone on the plinth to assist with blinding. The blood sample will be retained in the Arthrex ABS-10010S Double Syringe with Syringe Cap and then separated using a soft spin centrifuge for 5 min at 1500 rpm/rcf. Three to four mL of platelet rich plasma will be pulled into a smaller syringe that is wrapped in opaque tape to conceal the contents of the syringe. The ACP is injected into the torn region of the tendon.
16171273|NCT01614223|Drug|Corticosteroid (celestone) injection|Preparation of the blood sample is identical for patients in this group except that the blood sample will ultimately be discarded instead of injected. The syringe is blinded with opaque tape making it identical to the ACP group syringe and injected into the torn area of the tendon.
16171274|NCT01614210|Drug|Tamoxifen|All patients will take tamoxifen 20 mg po daily for 7 days prior to surgery and for 14 days after surgery.
16171275|NCT01614210|Procedure|Breast cancer surgery|Breast cancer surgery
16171276|NCT01614197|Drug|Temsirolimus|Dose will be assigned at study entry. Give IV over 30 minutes on days 1 and 8.
16171277|NCT01614197|Drug|Etoposide|100 mg/m2 IV over 1-2 hours daily x 5 on Days 1-5.
16171278|NCT01614197|Drug|Etoposide|For patients allergic to etoposide. 100 mg/m2 IV daily x 5 days on days 1-5.
16171279|NCT01614197|Drug|Cyclophosphamide|440 mg/m2 IV daily x 5 on Days 1-5 given over 30-60 minutes.
16171310|NCT01613937|Behavioral|Dulce Mother lifestyle training program|12 once weekly culturally tailored lifestyle management sessions
16171658|NCT01611090|Drug|Ibrutinib|Type=exact number, unit=mg, number=420 , form=capsule, route=oral use. Capsule is taken once daily continuously.
16171280|NCT01614197|Drug|Methotrexate|"PATIENTS WITH CNS 1 COURSES 2, 4, 6, 8: Give intrathecally to patients who were CNS1 at study entry day 1 of each course at the doses listed below.
~Age 1 - 1.99 give 8 mg of methotrexate
~Age 2 - 2.99 give10 mg of methotrexate
~Age 3 - 8.99 give 12 mg of methotrexate
~Age ≥ 9 give 15 mg of methotrexate
~PATIENTS WITH CNS 2 or 3 DISEASE
~-COURSE 1: Give intrathecally to patients with CNS 2 or 3 disease at the doses defined by age below on day 6 and then weekly until the patient is CNS 1.
~COURSES 2-8: Give intrathecally to patients who were CNS 3 at study entry on day 1 of each course.
~8 mg for patients age 1-1.99
~10 mg for patients age 2-2.99
~12 mg for patients 3-8.99 years of age
~15 mg for patients >9 years of age"
16171281|NCT01614197|Drug|Hydrocortisone|"Given with Methotrexate and Cytarabine for patients with CNS 2 or 3 disease.
~COURSE 1: Give intrathecally to patients with CNS 2 or 3 disease at the doses defined by age below on day 6 and then weekly until the patient is CNS 1.
~COURSES 2-8: Give intrathecally to patients who were CNS 3 at study entry on day 1 of each course.
~8 mg for patients age 1-1.99
~10 mg for patients age 2-2.99
~12 mg for patients 3-8.99 years of age
~15 mg for patients >9 years of age"
16171282|NCT01614197|Drug|Cytarabine|"For Patients who are CNS1 COURSE 1: Give intrathecally to patients with CNS1 disease at the dose defined by age below on day 1 of course 1 if no other IT was given within 1 week of day 1 of course 1
~Age 1 - 1.99 give 30 mg of Cytarabine
~Age 2 - 2.99 give 50mg of Cytarabine
~Age ≥ 3 give 70 mg of Cytabine
~For Patients with CNS 2 or 3 Disease COURSE 1: Give intrathecally to patients with CNS 2 or 3 disease at the doses defined by age below on day 1 if no other IT chemotherapy given within 1 week of day 1 of course 1. Then give weekly until the patient is CNS 1 or 2 (investigator discretion). No more than 5 weekly doses to be given in cycle 1.
~COURSES 2-8: Give intrathecally to patients who were CNS 2or 3 at study entry on day 1 of each course.
~16 mg for patients age 1-1.99
~20 mg for patients age 2-2.99
~24 mg for patients 3-8.99 years of age
~30 mg for patients >9 years of age"
16171283|NCT01614184|Drug|Fluorescein|Fluorescite® (fluorescein injection, USP) 10% fluorescein sodium diluted to from 1% to 0.001% in sterile saline, 0.25 ml injected intradermally peri-tumoral or peri-areolar. A single dose regimen.
16171284|NCT01614171|Biological|Human recombinant growth hormone|growth hormone treatment for 6 months (daily, weight based)
16171285|NCT01614158|Device|perimetry|perimetric examination using static stimuli, assessing the entire (80 degree) visual field with a fast thresholding algorithm (GATE) [Schiefer 2008] to know the extent/ magnitude of the visual field defect and its variability within the cohort and over time
16171286|NCT01614158|Other|D-BCVA|D-BCVA using EDTRS chart
16171287|NCT01614158|Other|RAPD|RAPD using swinging flashlight test
16171288|NCT01614158|Device|IOP|IOP using applanation tonometer
16171289|NCT01614158|Device|Spectralis OCT|RNFT and RNFV using Spectralis OCT (star scan, ring scan 2,8 mm and volume scan)
16171290|NCT01614158|Other|Fundus photography|Optic disk morphology will be documented by fundus photography
16171291|NCT01614132|Drug|maintenance chemotherapy (vincristin, cisplatin and CCNU)|maintenance chemotherapy of maximum of 8 cycles á 42 days
16171292|NCT01614132|Radiation|Radiotherapy|Radiotherapy of the partial brain
16171293|NCT01614119|Other|Hypoxic exposure|Subjects breath either normoxic or hypoxic (FiO2 = 12%) gas mixture
16171294|NCT01614106|Behavioral|Retention Clinic|The central components of the Retention Clinic will include: Primary HIV Care; Patient Navigator services (including Informational support, Educational information, Motivational/Emotional support, Skill Building activities); Mental Health Services; and On-Site Substance Abuse Treatment (including Motivational Enhancement Therapy and Cognitive Behavioral Therapy).
16171295|NCT01614093|Drug|Oxytocin|Single dose intranasal oxytocin (24 IU)
16171296|NCT01614093|Drug|Placebo|Placebo- Sugar pill
16171297|NCT01614067|Drug|Ganirelix acetate|Subjects will receive 7 days of pre-treatment with the GnRH antagonist
16171298|NCT01614054|Other|Survey of patient's smoking habits|Nicotine replacement therapy (inhalers, patches, gum, lozenges) at the discretion of the health care provider
16171299|NCT01614041|Drug|Usual dose treatment of Tandospirone|Usual dose treatment of Tandospirone, oral, 30 mg/day
16171300|NCT01614041|Drug|Comparative high dose of tandospirone treatment|Comparative high dose of tandospirone treatment, oral, 60 mg/day
16171301|NCT01614028|Procedure|Total Hip Arthoplasty|
16171302|NCT01614015|Behavioral|Supervision|SAU consists of a 1-hour weekly group supervision session with the clinical team (typically 3-6 therapists). The on-site supervisor also conducts individual supervision sessions with each member of the clinical team. As such, the usual FFT supervision practice involves each therapist receiving two hours of supervision per week (one hour of group, one hour of individual). Supervision sessions are conducted by an on-site supervisor who has received intensive training in FFT supervision. The on-site supervisor also continues to receive feedback and guidance from a national consultant (FFT LLC) for one hour per month.
16171303|NCT01614015|Behavioral|Observational Supervision|One intent of BOOST is to provide ongoing development of therapist clinical skills, and identify novel approaches to unique family circumstances that are consistent with FFT treatment. BOOST involves the BOOST supervisor reviewing the recorded therapy sessions prior to supervision sessions with the therapist and on-site FFT supervisor and weekly group and/or individual supervision meetings during which the BOOST supervisor provides feedback and coaching to the therapist. The goal of observation-based supervision is to ensure feedback to therapists is based on the supervisors' direct judgments about therapist behaviors, model adherence, and delivery of FFT services rather than relying solely on therapist self-report of session activities and interactions.
16171304|NCT01613989|Procedure|Prosthetic hip surgery, operated under manual control|: Hip replacement is performed in supine side position. Cup is positioned under manual control with the aid of a manual ancillary.
16171305|NCT01613989|Procedure|Prosthetic hip surgery operated under navigation based on EOS imaging|The patient will be installed in supine side position. The cup will be navigated with the technique based on EOS imaging. This technique requires the registration of the homolateral antero superior iliac spine and the homolateral postero superior iliac spine only. It does not require the registration of the pubis or any other controlateral points which are poorly accessible in the supine side position
16171306|NCT01613976|Drug|Panobinostat|
16171307|NCT01613963|Drug|Immunosuppressive Agents|Treatment with systemic corticosteroids and/or immunosuppressive agents Treatment with local corticosteroids and other drugs
16171308|NCT01613950|Drug|AUY922|AUY922 is a non-geldanamycin inhibitor of the heat shock protein 90 (HSP90).
16171311|NCT01613924|Device|Split face: handheld acne heat based device (Zeno Hot Spot) and no treatment|Subjects will apply the actual device to every inflammatory acne facial lesion on one half of the face and no treatment to every inflammatory acne lesion on the other half of the face at 6 hour intervals for a total of 3 treatments. Follow up will occur daily over a 5 day period.
16171312|NCT01613924|Device|Split face: handheld acne heat based device, Zeno Hot Spot, and topical benzoyl peroxide 4%|Subjects will apply the actual device to every inflammatory acne facial lesion on one half of the face at 6 hour intervals for a total of 3 treatments. Subjects will apply benzoyl peroxide to the other half of the face daily for 5 days.
16171313|NCT01613898|Biological|Blood tests|Blood tests
16171314|NCT01613885|Other|No Intervention|This study does not involve any intervention other than obtaining blood, nasal/cheek/throat/skin swabs, saliva, sputum, urine, and stool samples, breathing and skin tests.
16171315|NCT01613872|Other|Mindfulness Based Stress Reduction|An 8 week protocol of stress reduction sessions using gentle yoga and breath meditation
16171316|NCT01613846|Drug|Sorafenib+Pazopanib|Sorafenib (first-line) followed by Pazopanib (second-line)
16171317|NCT01613846|Drug|Pazopanib+Sorafenib|Pazopanib (first-line) followed by Sorafenib (second-line)
16171318|NCT01613833|Procedure|Blood Draw|Blood drawn for A2M levels to be assayed at Cytonics
16171319|NCT01613833|Procedure|Joint Aspirate Harvest|Joint aspirate harvested for A2M levels to be assayed at Cytonics
16171320|NCT01613833|Procedure|Blood Draw|Blood drawn for A2M levels to be assayed at Cytonics
16171321|NCT01613833|Procedure|Joint Aspirate Harvest|Joint aspirate harvested for A2M levels to be assayed at Cytonics
16171322|NCT01613820|Drug|Ketamine|ketamine IV 0.25mg/kg infusions twice a week for 3 weeks as augmentation of ongoing antidepressant regimen.
16171323|NCT01613820|Drug|Scopolamine|Scopolamine 2ug/kg over 15 minutes twice a week for 3 weeks as augmentation of ongoing antidepressant regimen
16171324|NCT01613807|Drug|Insulin LISPRO|Humalog® Mix50/50™ [50% insulin lispro protamine suspension and 50% insulin lispro injection, (rDNA origin)], three times daily at mealtime. Dose determined by blood glucose history.
16171325|NCT01613807|Drug|Insulin, Long-Acting and Insulin LISPRO|Long-acting insulin three times daily on rising, mid-afternoon, and before bed, and insulin lispro three times daily at mealtime. Doses determined by blood glucose history and carbohydrate content of the meal.
16171326|NCT01613794|Drug|Rosuvastatin|20 mg od
16171327|NCT01613781|Other|TOF count-guided partial NMB|TOF count-guided partial NMB Using partial neuromuscular blockade to maintain train-of-four response of two, TOF response measured by the neuromuscular transmission module (NMT module)
16171328|NCT01613781|Other|T1/Tc guided partial NMB|Using partial neuromuscular blockade to maintain T1/Tc amplitude of 50%, T1/Tc amplitude measured by the neuromuscular transmission module (NMT)
16171329|NCT01613768|Drug|eribulin mesylate|Given IV
16171330|NCT01613755|Drug|Metformin, dipyridamole|Metformin 500 mg twice daily for four days Dipyridamole 200 mg twice daily for four days
16171331|NCT01613755|Drug|Metformin|Metformin 500 mg twice daily for four days
16171332|NCT01613729|Drug|Rosuvastatin 5 mg|Rosuvastatin 5 mg
16171333|NCT01613729|Drug|Rosuvastatin 10 mg|
16171334|NCT01613716|Drug|Ozurdex|Ozurdex .7 mg injected into the treated eye
16171335|NCT01613703|Drug|ONO-2952|1 mg to 200 mg QD at a single descending dose
16171336|NCT01613690|Drug|NVA237|NVA237 is administered via a BREEZHALER device
16171337|NCT01613677|Drug|BKM120|
16171338|NCT01613664|Drug|tisseel|The product will be given as a 2 mL bottle per patient, which will be spread along the staple line. If necessary, a second bottle of 2 mL is used. The precautions for use are described in the user manual.
16171339|NCT01613664|Other|no tisseel|the surgeon does not applied tissucol during the surgery
16171340|NCT01613651|Procedure|robot-assisted laparoscopic surgery|Undergo RALP
16171341|NCT01613651|Other|questionnaire administration|Ancillary studies
16171342|NCT01613651|Other|intraoperative complication management/prevention|Undergo placement of pelvic drain
16171343|NCT01613638|Other|meconium samples + maternal self-questionnaire|meconium samples + maternal self-questionnaire
16171344|NCT01613625|Procedure|Elastography|
16171345|NCT01613612|Procedure|core decompression|minimal surgical invention to drill a core to the femoral head to release pressure
16171346|NCT01613612|Procedure|Enriched BMCs implantation combined with core decompression|Patients are subjected to bone marrow aspiration from the anterior iliac crest. Mononuclear cells are enriched from patients' bone marrow by centrifuge, which are grafted with autologous cortical bone and implanted to the necrotic zone of the femoral head.
16171347|NCT01613599|Drug|Rituximab|Participants received rituximab at the discretion of their treating physicians.
16171348|NCT01613586|Drug|ASP3652|Oral
16171349|NCT01613586|Drug|Placebo|Oral
16171350|NCT01613573|Drug|somatropin AQ|somatropin injection 0.2mg/kg/w once per day, inject for 7 continuous days 4 weeks for cleaning period
16171351|NCT01613573|Drug|pegylated somatropin|Pegylated somatropin 0.2mg/kg/w once per week, for continuous 6 weeks Subcutaneous injection
16171352|NCT01613560|Drug|AI adjuvant therapy|preoperative endocrinotherapy was performed by AI for 4-6 months;surgery;pathological evaluation after surgery;AI adjuvant therapy for 5 years
16171353|NCT01613560|Drug|AI+chemotherapy adjuvant therapy|preoperative endocrinotherapy was performed by AI for 4-6 months;surgery;pathological evaluation after surgery;AI adjuvant therapy for 5 years after adjuvant chemotherapy
16171354|NCT01613560|Drug|AI adjuvant therapy|preoperative endocrinotherapy was performed by AI for 4-6 months;surgery;pathological evaluation after surgery;AI adjuvant therapy for 5 years
16171355|NCT01613547|Drug|Amoxicillin|80 mg/kg/day for 7 days
16171356|NCT01613547|Drug|Placebo|7 days
16171357|NCT01613534|Drug|Sucralfate|Argon plasma coagulation treatment followed by oral sucralfate (6 grams b.i.d.) for four weeks
16171358|NCT01613534|Drug|Placebo|Argon plasma coagulation treatment followed by placebo administration for four weeks
16171427|NCT01612949|Other|photographing head and neck|Taking three photographs of head and neck-one photograph from front, one from left and one fron right. The photographs are analyzed by facial structure software to create face model.
16171860|NCT01609374|Device|Anterior plate system with corticocancellous allograft bone|Cervical fusion
16171359|NCT01613521|Other|DCE-MRI and 18F-FMISO PET|DCE-MRIs: (i) Baseline DCE-MRI within two weeks before chemoradiation; (ii) Second DCE-MRI after the second week of chemoradiation (within a week); (iii) Third DCE-MRI three months after chemoradiation. iii. 18F-FMISO PET: Baseline 18F-FMISO PET within two weeks before chemoradiation (only 10 patients as a pilot study). iv. Clinical Follow-up: (i) Physical examination (every 3 months); (ii) Pap smear or cervical biopsy (every 3 months); (iii) follow-up imaging studies (CT and/or MRI) as per routine clinical follow-up of patients.
16171360|NCT01613508|Procedure|Direct Anterior Approach|
16171361|NCT01613508|Procedure|Mini-Posterior Approach|
16171362|NCT01613495|Drug|Placebo|After the first study visit, subjects will begin monthly treatment with either the study drug or a placebo (an inactive substance), which will be continued for the first six months of the study. For the last six months of the study, subjects will be switched to the opposite treatment. During these study periods participants will return monthly for administration of study medication, physical examination, and blood draw to check liver enzymes.
16171363|NCT01613495|Drug|Octreotide|They will be admitted to the inpatient unit of the OCTRI for testing six times. During each of these visits, testing will include measuring how well glucose (sugar) is processed, how much energy is burned off as heat, their amount of body fat, levels of the hormone ghrelin, and how much food is eaten at a meal. After the first study visit, subjects will begin monthly treatment with either the study drug or a placebo (an inactive substance), which will be continued for the first six months of the study. For the last six months of the study, subjects will be switched to the opposite treatment. During these study periods participants will return monthly for administration of study medication, physical examination, and blood draw to check liver enzymes.
16171364|NCT01613482|Radiation|cerebral prophylactic radiation|24Gy, 12 fractions of 2 Gy
16171365|NCT01613482|Drug|Trastuzumab|Weekly, 2mg/kg of corporal weight
16171366|NCT01613482|Drug|Other chemotherapy in association with Trastuzumab|other chemotherapy is possible to associate with Trastuzumab as well as a change of chemotherapy protocol is possible while maintening Trastuzumab 8 weeks is required between last injection of chemotherapy and first radiotherapy session
16171367|NCT01613469|Drug|5FU/Leucovorin|450 mg/m2 of 5-FU plus 50 mg Leucovorin given in 3 cycles during radiation (one cycle is the administration every day for 3 consecutive days, a cycle is 21 days)followed by 450 mg/m2 of 5-FU plus 50 mg Leucovorin given in 3 cycles after completion of radiation.
16171368|NCT01613456|Dietary Supplement|Saccharomyces cerevisiae CNCM I-3856|2 capsules/day during 12 weeks
16171369|NCT01613456|Dietary Supplement|Placebo|"Capsule with comparable organoleptic properties and weight than the experimental product.
~2 capsules/day during 12 weeks"
16171370|NCT01613430|Behavioral|Coach Training (COACH)|"Participants and their coaches receive Printed Educational Materials (PEM). Additionally, coaches will receive a 40-minute cancer-related training session led by a research staff member. The coaches will be provided basic information about different types of cancer screenings, how to schedule and keep medical visits, and how to communicate with health care providers about cancer screening. The session will be interactive, including short video presentations, role plays and exercises. Coaches will be given brochures on cancer screening for the three cancer types, a checklist for the coach and a Things to Remember diary checkup list, and resources addressing well-known barriers to cancer screening."
16171371|NCT01613430|Behavioral|Printed Educational Materials (PEM)|Participants and their coaches will be provided with educational brochures about cancer screening for colorectal, breast and cervical cancers at the completion of the baseline survey.
16171372|NCT01613417|Drug|gadoteridol|ProHance 0.1 mmol/kg
16171373|NCT01613417|Drug|gadobutrol|Gadovist/Gadavist 0.1 mmol/kg
16171374|NCT01613404|Other|No intervention|Patients will be treated with approved erythropoiesis stimulating agent (Eprex or Aranesp) will be administered according to actual clinical practice according to guidance in the current approved product monographs. All patients will receive treatments that are prescribed by their physician according to actual clinical practice.
16171375|NCT01613378|Other|No intervention|No intervention administered in this study
16171376|NCT01613365|Drug|Chlorhexidine Gluconate|Oropharyngeal and nasopharyngeal decontamination with Chlorhexidine Gluconate
16171377|NCT01613365|Drug|Placebo|Oropharyngeal and nasopharyngeal decontamination with placebo
16171378|NCT01613352|Other|Ambulatory surgery|Sentinel node mapping was done on the previous day and the patients were operated on first in the morning.
16171379|NCT01613339|Other|Balance training using Body awareness therapy|Once a week, 1 hour for 8 weeks.Body awareness training may be performed by physiotherapist. Exercises are performed in standing, sitting and lying. Example of exercises are weight-balancing in standing and relaxation exercises.
16171380|NCT01613326|Drug|NVA237|NVA237 50 μg inhalation capsules once a day, delivered via SDDPI
16171381|NCT01613326|Drug|Tiotropium|Tiotropium 18 μg once a day delivered via HandiHaler® device
16171382|NCT01613326|Drug|Placebo to tiotropium|Placebo to tiotropium 18 μg o.d. once a day delivered via HandiHaler® device.
16171383|NCT01613326|Drug|Placebo to NVA237|Placebo to NVA237 50 μg once a day delivered via SDDPI
16171384|NCT01613326|Drug|salbutamol/albuterol|salbutamol/albuterol given as a rescue medication via inhaler when needed
16171385|NCT01613313|Drug|Collagenase Clostridium Histolyticum|This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.
16171386|NCT01613300|Drug|Ofatumumab|Ofatumumab as part of the reduced intensity conditioning regimen (RIC)
16171387|NCT01613287|Device|TheraSorb® - Ig flex|"TheraSorb® Treatment with one TheraSorb® Ig flex adsorber pair, used exclusively with the LIFE 18® apheresis system for extracorporeal application for IA therapy.
~5 treatments performed over 5 to 8 consecutive days."
16171388|NCT01613274|Other|gum chewing|gum chewing three times a day for up to 20 minutes
16171389|NCT01613274|Other|no gum chewing|no gum chewing
16171390|NCT01613261|Drug|TAK-733 and alisertib|"TAK-733 will be administered orally once daily (QD) on Days 1 through 14 of the 21-day cycle.
~Alisertib will be administered orally twice daily (BID) on Days 1 through 7 of the 21-day cycle."
16171496|NCT01612351|Drug|Lapatinib|Lapatinib (1000mg) taken by mouth once a day either one hour before or one hour after a meal for 6 weeks during induction chemotherapy. Participants deemed high risk following transoral surgery will additionally take lapatinib daily concurrently with their chemoradiation therapy.
16172447|NCT01604408|Drug|Placebo|Administered SC
16171391|NCT01613248|Drug|MK-1602|Single 1, 10, 25, 50 or 100 mg dose of MK-1602 taken at onset of migraine of moderate or severe intensity. Dosage form is film coated tablet for oral administration. Dose is provided to participants as a blinded bottle of tablets packaged to achieve the various MK-1602 dose levels to be studied. Participants will be instructed to take all study medication from the bottle when they treat their migraine headache.
16171392|NCT01613248|Drug|Placebo-matching MK-1602|Single administration of placebo-matching MK-1602 taken at onset of migraine of moderate or severe intensity. Dosage form is film coated tablet for oral administration. Dose is provided to participants as a blinded bottle of tablets packaged to achieve placebo study medication. Participants will be instructed to take all study medication from the bottle when they treat their migraine headache.
16171393|NCT01613248|Drug|Rescue medication|"If moderate or severe migraine headache pain continues 2 hours after dose of study medication or if migraine headache comes back within 48 hours,
~Participants will be allowed to take their own rescue migraine medication, which may include analgesics (e.g., nonsteroidal anti-inflammatory drugs [NSAIDs]), anti-emetics, triptans or other medication not explicitly excluded."
16171394|NCT01613235|Other|Induced hypertension|Blood pressure will be raised in order to improve cerebral blood flow (CBF). In case of a low cardiac output, inotropics will be added. Induced hypertension will be continued for at least 48 hours when patients show some improvement within the first 24 hours. After 48 hours, the dose of vasopressor will be tapered daily, and resumed in case of clinical deterioration. In patients who do not show any improvement within 24 hours, induced hypertension will not be continued.
16171395|NCT01613222|Device|Pulse oximetry|Pulse oximetry measurement using SpO2 sensors, patient monitors, co-oximeters, and various modules.
16171396|NCT01613209|Drug|Candesartan cilexetil|candesartan 16 mg tablets p. o. for 14 days (morning), then candesartan 32 mg tablets for 28 day (morning)s,
16171397|NCT01613209|Drug|Olmesartan/Amlodipin|olmesartan/amlodipine 40/5 mg tablets for 14 days (morning), then olmesartan/amlodipine 40/10 mg tablets for 28 days (morning), then olmesartan/amlodipine 40/10 mg tablets for 42 days (evening)
16171398|NCT01613196|Other|Positron Emission Tomography with 18F-Fluoro-deoxy-glucose|"2 or 3 FDG-PET scans will be performed in all patients : at inclusion*, end of treatment and 6 months after completion of treatment in cases of persistent uptake
~*except if already done in the last 15 days."
16171399|NCT01613183|Drug|Chinese herbal Medicine|The intervention of Chinese Medicine group is not fixed. The clinicians provide the prescription to patient base their own Chinese Medicine theory. Chinese clinicians can adjust the medicinal in prescription based on the condition of patient during the treatment procedure. The prescription of Chinese clinicians' are pure Chinese herb.
16171400|NCT01613183|Other|the dummy of a Chinese Medicine prescription|Patients in placebo group will receive the dummy of the core drug patterns screened in previous retrospective study. The previous core drug patterns include Fried semen Ziziphi Spinosae, Tuckahoe, Preparation of Polygala, Chinese Angelica root, Lotus heart, White peony root, dried tangerine peel, acorus calamus, Coptis chinensis, and Licorice health.
16171401|NCT01613170|Drug|Toviaz|Toviaz 4mg daily
16171402|NCT01613170|Drug|Premarin|Premarin cream 1 g per vagina twice weekly
16171403|NCT01613170|Drug|Placebo cream|Placebo cream 1 g per vagina twice weekly, to mimic Premarin cream
16171404|NCT01613131|Drug|Mirena|Mirena (levonorgestrel-releasing intrauterine system), 52 mg (20 mcg/day), 5 year duration (study duration 6 months).
16171405|NCT01613131|Drug|Estradiol|Topical, .06%, Applied once daily for 50 days.
16171406|NCT01613131|Drug|Placebo Gel|Topical Gel, Applied once daily for 50 days, Placebo comparator.
16171407|NCT01613118|Drug|RE-021 (Sparsentan)|Oral, once-daily
16171408|NCT01613118|Drug|Irbesartan|Oral, once-daily
16171409|NCT01613105|Drug|Acarbose (Precose/Glucobay, BAYG5421)|Oral Glucobay 25 titrated to Glucobay 50 upto three times a day with meals or as per investigators descretion.
16171410|NCT01613092|Drug|Incremental|Cefazolin and Vancomycin pre-op, bacitracin wash and postoperative cefalexin or clindamycin
16171411|NCT01613092|Drug|Cefazolin|Preoperative antibiotic
16171412|NCT01613079|Drug|Tripterygium wilfordii Hook F|Oral T2(Tripterygium wilfordii Hook F) 20mg thrice daily for 24 weeks.
16171413|NCT01613079|Drug|Methotrexate|Oral methotrexate 7.5-12.5mg per week for 24 weeks. The starting dose was 7.5mg per week, then increased to 12.5mg（max 0.3mg/Kg） per week in 4 weeks. Folic acid at the dose of 10mg per week were applied to all patients.
16171414|NCT01613066|Procedure|Intrabone Allogeneic Transplant|Unrelated single unit intrabone cord blood transplantation
16171415|NCT01613053|Drug|Glivec|800 mg per day
16171416|NCT01613040|Drug|Moxifloxacin|Single oral dose on Day 1
16171417|NCT01613040|Drug|Moxifloxacin|Single oral dose on Day 11
16171418|NCT01613040|Drug|RO4917838|Multiple daily low doses of RO4917838 for 10 days
16171419|NCT01613040|Drug|RO4917838|Multiple daily oral high doses of RO4917838 for 10 days
16171420|NCT01613040|Drug|RO4917838 placebo|Oral daily doses of placebo to RO4917838 for 10 days
16171421|NCT01613027|Biological|Rituximab|Rituximab administered according to prescribing information and normal clinical practice.
16171422|NCT01613014|Drug|ABT-436|Target dose - 400mg BID
16171423|NCT01613014|Drug|Matched Placebo - Sugar Pill|Target Dose - 2 pills BID
16171424|NCT01612988|Drug|BOMP|"Day-8 OMB prephase:
~Ofatumumab 300 mg IV day -8 Methylprednisolone 100 mg TD IV day -8
~BOMP cycle 1 and 2 :
~Ofatumumab 1000 mg IV day 1 and day 15 Bendamustine 70mg IV day 2 and ady 3 Methylprednisolone 1000 mg/m² IV day 1, 2 and 3 Methylprednisolone 100 mg TD IV day 15
~BOMP cycle 3 to 6 :
~Ofatumumab 1000 mg IV day 1 Bendamustine 70mg IV day 2 and day 3 Methylprednisolone 1000 mg/m² IV day 1, 2 and 3"
16171425|NCT01612975|Drug|Naproxen|Intervention arm involves administering 500mg Naproxen BID to participants and 40mg of Pantoprazole in tandem. Pantoprazole will negate gastrointestinal consequences of Naproxen and reduce the likelihood of a complication occurring. Participants will take Naproxen at the above dosage from the time of surgery to four weeks following surgery. They will attend scheduled check-ups where their vitals will be recorded, as well as laboratory indicators of gastrointestinal complications (creatinine levels, etc) for their safety. This experiment is double-blinded so neither investigators nor participants will know which arm of the study they belong to.
16171426|NCT01612975|Drug|Placebo|Inert, inactive placebo pill similar in appearance to naproxen allocation. To be taken twice daily for 4 weeks total along with 40mg pantoprazole.
16171428|NCT01612936|Biological|Bronchoscopy, Segmental Allergen Challenge and Broncheoalveolar Lavage|"On the day of the first bronchoscopy,BAL will first be performed in the lingula without instillation of diluent or allergen.Then, a 2-ml aliquot of isotonic diluent is instilled into the right upper lobe. Then, the procedure will be repeated in the right middle lobe with instillation of 2-ml of standardized cat or mite allergen solution.A test dose concentration of allergen is administered first consisting of 2 ml of allergen at 1/10th(Cat,D.farinae) or 1/30th(D. pteronyssinus) the threshold concentration.If on visual inspection through the bronchoscope, there is no evidence of mucosal inflammation after two minutes, a second segmental allergen challenge will be done in the right middle lobe using 2-ml of full-dose allergen at the threshold concentration(Cat,D.farinae) or 1/3th the threshold concentration(D.pteronyssinus).This dose will be predetermined by quantitative skin prick testing.A second bronchoscopy is performed 24 hours after delivery of allergen extract and diluent."
16171429|NCT01612936|Procedure|PET-CT imaging(13NN perfusion/ventilation, 18FDG inflammation, and CT imaging)|Imaging is first performed the evening prior to the 1st bronchoscopy.An IV catheter is placed.An attenuation correction is performed to remove image distortion using a chest CT volumetric scan.Subjects are instructed to exhale to the same mean lung volume of the CT scan and hold their breath for 20sec.Simultaneous with apnea,13NNsaline is injected IV and a series of PET scans is acquired.Then subjects resume breathing, matching their previous respiratory rate and tidal volume.After 3 min,within an interval of 1 min,spirometry and 2 deep inhalations are performed,followed by 1 min of washout. For the second imaging visit, which will occur 24 hour later, the imaging sequence will be repeated as described above, but will also include 18FDG infusion.At least 30 minutes after the 13NN injection,10mCi of 18FDG is infused. Then, images are collected over a 75 minutes.Venous blood is sampled at 5 different time points over a 40-45 minute time window to determine plasma radioactive levels.
16171430|NCT01612923|Other|Midwife|gynecological exam and ultrasound and contraceptive advice provided by midwife
16171431|NCT01612910|Drug|oral microencapsulated diindolylmethane|Patients receive oral microencapsulated diindolylmethane orally (PO) twice a day (BID) for 1 year in the absence of disease progression or unacceptable toxicity
16171432|NCT01612910|Other|laboratory biomarker analysis|Correlative studies
16171433|NCT01612897|Other|Computer based care reminders|Physicians in the intervention clinic will receive computer generated reminders to screen for autism among children of appropriate age visiting the clinic.
16171434|NCT01612884|Drug|Prasugrel|Prasugrel 60mg loading dose at time of PCI if clopidogrel non-responder
16171435|NCT01612884|Drug|Clopidogrel|Clopidogrel 300mg loading dose at time of PCI if clopidogrel responder
16171436|NCT01612871|Drug|Tamoxifen, Letrozole , Anastrozole, Exemestane|"Current first line metastatic hormone therapy treatment in hormone dependent breast cancer :
~Tamoxifen 20 mg/day, Letrozole 2.5 mg/day, Anastrozole 1 mg/day, Exemestane 25mg/day"
16171437|NCT01612858|Drug|Metformin|Metformin at a dose of one 500mg tablet twice a day with meals for one week, after which the dose will increase to 500 mg three times a day with meals for the remaining 11 weeks of the study.
16171438|NCT01612858|Drug|Pioglitazone|Pioglitazone at a dose of one 30 mg tablet once per day for the 12 weeks of the study.
16171439|NCT01612845|Procedure|Arthroscopic repair without platelet rich fibrin|after the tendon is repaired, no additional procedures are performed and no PRF is administered
16171440|NCT01612845|Biological|PRF (vivostat ®) administration after rotator cuff repair|7cc. of autologous PRF are locally administered to the repair site after reconstruction of the rotator cuff
16171441|NCT01612832|Drug|Pregabalin|Patients in one group will receive 150 mg of PGL at 20:00 h the night before surgery and at 1.5 h before surgery, and will undergo surgery under general anesthesia (GA).
16171442|NCT01612832|Other|Control|pain treatment as customary in the department
16171443|NCT01612806|Device|PriMatrix|fetal bovine dermal scaffold
16171444|NCT01612806|Device|PriMatrix Ag|fetal bovine dermal scaffold with Ag
16171445|NCT01612806|Procedure|moist wound therapy|standard of care moist wound therapy
16171446|NCT01612793|Device|AlphaCore Device|multiple stimulation treatments per day for duration of hospitalization
16171447|NCT01612780|Device|XprESS Multi-Sinus Dilation Tool|Sinus balloon dilation
16171448|NCT01612767|Device|PRO-Kinetic Energy Stent|Coronary artery stent implant
16171449|NCT01612754|Behavioral|Noise reduction work place rules|"Information conferences for all theatre staff (100%)on the detrimal effects of high noise levels in the operating theatre. Issue of workplace rules on handouts and poster on theatre doors: Ban of all mobile phones from theatre. Only conversations about the ongoing case are allowed. No restocking etc. during an operation and no work in this operating room concerning other patients (e.g. later on the list). Turnig of of unnecessary suckers, warming devices etc. . No in and out during the procedure.
~Technical: Sound Ears (TM, Sound Ear A.S. Copenhagen, Denmark) taped to all 4 Walls. Optical Telephones."
16171450|NCT01612754|Behavioral|Presence of an examiner in the concerned theatre|Research Clerk present in theatre, writes on note pad.
16171451|NCT01612741|Drug|Acarbose (Precose/Glucobay, BAYG5421)|Oral Glucobay 25 titrated to Glucobay 50 three times a day with meals or as per investigators descretion.
16171452|NCT01612728|Other|Women without Arthralgia|For mild arthralgia, women will try the following interventions in the following order: 1) Weight-bearing exercise program, and 2) Glucosamine & Chondroitin supplements. For women with mild to moderate arthralgia, they will try to the following interventions in this order: 1) Acupuncture, 2) Indomethacin twice daily as needed, 3) Switch to a different aromatase inhibitor, and 4) Switch to tamoxifen.
16171453|NCT01612728|Drug|Women with Arthralgia|
16171454|NCT01612715|Other|Segmental Allergen Challenge|segmental allergen challenge
16171455|NCT01612702|Drug|Dexamethasone|Dexamethasone 10 mg intravenous administration
16171456|NCT01612689|Device|Accelerometer Device|A sensor platform that enables physiological monitoring in routine, home or office environments.
16171457|NCT01612676|Drug|FE 202158|
16171458|NCT01612663|Device|Pain relief by Acupuncture needle at non-specific site|
16171459|NCT01612663|Device|Acupuncture needle|
16171460|NCT01612663|Device|Acupuncture needle|
16171461|NCT01612663|Device|Acupuncture needle|
16171462|NCT01612650|Device|tomosynthesis|2 incidences 3D numeric mammography
16171463|NCT01612650|Device|2D mammography|2 incidences 2D analogic mammography
16171554|NCT01611948|Drug|Placebo|125mg/d placebo pill for 8 weeks
16171464|NCT01612637|Behavioral|Pelvic floor muscle training and lifestyle advice|Group 1 will be individually examined and instructed in pelvic floor muscle training before the intervention starts by specialized physiotherapists. The examination includes a vaginal or an anal examination. The women attend six group sessions within 12 weeks containing structured information about POP and the possible affection of POP on quality of life, exercising and sexual relationship and information that could improve POP symptoms, such as bladder and bowel habits, coughing, heavy lifting, eating habits and weight loss. The women will perform pelvic floor muscle training in the group and perform pelvic floor muscle training at home. The training will be individually planned according to the findings of the pelvic floor physiotherapist. The women in the intervention group fill in an exercise diary and also describe on a Visual Analog Scale if the training causes any bother.
16171465|NCT01612637|Behavioral|Lifestyle advice|Group 2 attend six group sessions within 12 weeks containing structured information about POP and the possible affection of POP on quality of life, exercising and sexual relationship. The lifestyle advice contains information about life style changes that could improve POP symptoms, such as bladder and bowel habits, coughing, heavy lifting, eating habits and weight loss
16171466|NCT01612598|Other|counseling intervention|Undergo PCI
16171467|NCT01612598|Procedure|quality-of-life assessment|Ancillary studies
16171468|NCT01612598|Other|questionnaire administration|Ancillary studies
16171469|NCT01612598|Other|educational intervention|Undergo PCI
16171470|NCT01612546|Drug|cyclodextrin-based polymer-camptothecin CRLX101|Given IV
16171471|NCT01612546|Other|Laboratory biomarker analysis|Correlative studies
16171472|NCT01612546|Other|Pharmacological studies|Correlative studies
16171473|NCT01612520|Behavioral|telecoaching|"The COACH program trains patients to 'drive' the process of achieving and maintaining the target levels for their risk factors while working in association with their GP. The telephone coaching is aimed at improving self-efficacy by adhering to the prescribed therapy and making relevant behavior changes.
~The coaching model is a continuous five-stage coaching cycle: Stage 1. Finding out what the patient knows; Stage 2. Telling the patient what they should know; Stage 3. Assertiveness training; Stage 4. Setting an action plan; Stage 5. Reassessment at the next coaching session (monitoring).
~The coach monitors and registers: the biomedical risk factors, the lifestyle/behavioral risk factors and use of the recommended medications. Coaching is focused on eliminating the knowledge gap and motivating the patient to apply the appropriate lifestyle and medical therapy."
16171474|NCT01612507|Drug|600 mg Ceftaroline fosamil|1 h infusion
16171475|NCT01612507|Drug|Placebo|1 h infusion
16171476|NCT01612507|Drug|600 mg Ceftaroline fosamil|2 h infusion
16171477|NCT01612507|Drug|Placebo|2 h infusion
16171478|NCT01612494|Drug|Hypertonic Saline|intravenous formulation of 3% hypertonic saline in a bolus dose of 10ml/kg over one hour
16171479|NCT01612494|Other|Normal Saline|intravenous formulation of normal saline in a bolus dose of 10ml/kg over one hour
16171480|NCT01612481|Procedure|chest radiography|surveillance by radiography of chest every 3 months the first 2 years then every 6 month the third, forth and fifth years
16171481|NCT01612481|Procedure|chest CT|surveillance by CT of chest every 3 months the first 2 years then every 6 month the third, forth and fifth years
16171482|NCT01612468|Drug|Liraglutide|1.8 mg/day subcutaneous
16171483|NCT01612468|Drug|Placebo|1.8 mg/day subcutaneous
16171484|NCT01612455|Behavioral|LINC Case Management|The 1st case management (CM) session will be at the Narcology Hospital and will follow a modified strengths-based case management curriculum. As part of this first session, the CM will show a 10 minute video clip produced by a Russian NGO of HIV-infected patients talking about accessing HIV care. The CM will also tell the patient what his/her CD4 cell count is and discuss what it means with the patient. The case manager will help the client identify the outpatient HIV clinic on a map and will discuss basic drug harm reduction ideas with the client. The remaining 4 CM sessions will happen over the following 6 months. Sessions may happen at the HIV clinic, NGOs, or in the community. The HIV CM helps the client understand the importance of HIV care, identify barriers to care acquisition and recognize one's own strengths, abilities and assets to reduce self-identified barriers to care. The HIV CM's primary aim is to have the client attend an appointment at the HIV outpatient clinic.
16171485|NCT01612442|Behavioral|nutrition and agricultural education|Mothers of children aged 6-24 months received monthly nutrition education delivered by community health volunteers and agricultural education delivered by agricultural extension agents, in addition to standard monthly child welfare services delivered by Ghana Health Service
16171486|NCT01612442|Behavioral|nutrition education|Mothers of children aged 6-24 months received monthly nutrition education delivered by community health volunteers in addition to standard child growth monitoring services provided by the Ghana Health Service.
16171487|NCT01612429|Dietary Supplement|Amino acid supplementation|Single arm study in which dialysis patients will receive up to 500 mL of NephrAmine® (5.4% amino acids for injection; B. Braun Medical, Inc) containing 26.8 grams of essential amino acids at 125 mL/h during each dialysis session (3 times weekly for 6 weeks)
16171488|NCT01612416|Device|RS-3000 OCT measurements|Ganglion cell, retinal nerve fiber layer and retinal thickness measurements of normal subjects, primary open angle glaucoma and normal tension glaucoma patients using RS-3000 OCT RetinaScan
16171489|NCT01612403|Dietary Supplement|zinc sulfate|every participant took two capsules of zinc sulfate per day for three months (each one 220mg)
16171490|NCT01612377|Drug|Prednisolone-Dipyridamole|Oral, QD
16171491|NCT01612377|Drug|Prednisone|Oral QD Prednisone 5mg
16171492|NCT01612377|Drug|prednisone|Oral, QD prednisone 7.5mg
16171493|NCT01612364|Procedure|thoracic sympathetic block|Thoracic sympathetic block is sympathetic block of upper limb described by Leriche e Fontaine em 1925. The block is performed under radioscopic view, positioning the needle lateral the body of thoracic vertebra T3, where infuse anesthetic solution. The theoretical advantage over the stellate ganglion is its greater specificity and efficiency. Solution block: 5ml ropivacaine 0,75% + 5ml de triamcinolone 2%
16171494|NCT01612351|Drug|Carboplatin|Weekly carboplatin given intravenously for 6 weeks during induction chemotherapy.
16171495|NCT01612351|Drug|Paclitaxel|Weekly paclitaxel given intravenously prior to carboplatin infusion for 6 weeks during induction chemotherapy.
16171555|NCT01611948|Behavioral|Manual-guided behavioral counseling|Standardized manual-guided behavioral counseling performed 1 time per week for 8 weeks in conjunction with study drug or placebo.
16171497|NCT01612351|Drug|Cisplatin|Weekly cisplatin given intravenously for 6 weeks concurrent with ipsilateral radiation. Alternative regimens may be substituted for cisplatin in patients who are not candidates for cisplatin at the discretion of the investigator. If carboplatin is used, a maximum of 125 mL/min must be used, as per standard of care.
16171498|NCT01612351|Drug|Cisplatin|Cisplatin given once every 3 week cycle intravenously for 5-7 weeks concurrent with bilateral radiation and daily lapatinib. Alternative regimens may be substituted for cisplatin in patients who are not candidates for cisplatin at the discretion of the investigator. If carboplatin is used, a maximum of 125 mL/min must be used, as per standard of care.
16171499|NCT01612351|Radiation|Ipsilateral Radiation|After transoral surgery, subjects deemed medium risk will receive ipsilateral radiation as per standard of care 5 days/week for 6 weeks concurrent with weekly cisplatin.
16171500|NCT01612351|Radiation|Bilateral Radiation|After transoral surgery, subjects deemed high risk will receive bilateral radiation as per standard of care 5 days/week for 5-7 weeks concurrent with cisplatin every 3 weeks and daily lapatinib.
16171501|NCT01612351|Procedure|Transoral Surgery|Transoral resection by robotic or microscopic approach, which will be at the discretion of the treating surgeon.
16171502|NCT01612338|Behavioral|Targeted|Targeted letter and booklet
16171503|NCT01612338|Behavioral|Enhanced Tailored|Tailored letter and booklet, enhanced family communication and support brochure
16171504|NCT01612325|Device|Holmium-166 polylactic microspheres|Radioembolisation with 600 mg of Holmium-166 microspheres with a patient liver size adjusted activity. The desired whole liver dose is 60 Gy.
16171505|NCT01612312|Procedure|Thrombectomy|Manual thrombectomy will be performed in the thrombus aspiration group using an aspiration catheter utilized in daily clinical routine (Eliminate, Terumo Europe, Leuven, Belgium). In the standard PCI group, patients will be treated by conventional PCI according to local practice without thrombectomy.
16171506|NCT01612312|Procedure|Standard percutaneous coronary intervention|In the standard percutaneous coronary intervention (PCI) group, patients will be treated by conventional PCI according to local practice without thrombectomy.
16171507|NCT01612299|Drug|Zortress® /Everolimus|"Standard immunosuppression: THY 1-1.5 mg/kg/d qd for a total of 6 mg/kg •TAC trough targets 0-3 mo 8-12 ng/ml 4-6 mo 6-10 ng/ml >6 mo 5-8 ng/ml•Myfortic® or CEL 360mg or 500mg po BID, and receiving THY then Myfortic® or CEL 720 mg or 1000mg PO BID once THY induction completed• COR 500mg MET IV pre-op,125mg MET IV q24h x 2 doses (Post-Op Days 1 &2) 20mg Pred PO daily x 2 wks 15mg Pred PO daily x 2 wks 10mg Pred PO daily x 4 wks 5mg Pred PO daily x 4 wks 5 mg Pred PO every other day through mon 12.
~Experimental: TAC + Zortress® + COR In this arm patients will stop Myfortic®/CEL and start Zortress® at a dose of 1 mg PO BID with a target level of 3-8 ng/ml.At Zortress® level of at least 3 ng/ml TAC will be dosed to a target range as follows Randomization through mo 3 post-transplant 7-10 ng/ml 4-6 mo post transplant 5-8 ng/ml >6 mo post transplant 4-7 ng/ml."
16171508|NCT01612286|Drug|endostatin|Gemcitabine 1.0g/m2 d1,8 cisplatin 80mg/m2 endostatin 15mg/d 14days/cycle *4cycles
16171509|NCT01612273|Drug|Triflusal|Dose: 300mg bid, Mode of administration: oral, Duration: from randomization to 6 week, crossover-design.
16171510|NCT01612273|Drug|Aspirin|Dose: 150mg bid, Mode of administration: oral, from randomization to 6weeks, crossover-design.
16171511|NCT01612260|Drug|Shensong Yangxin capsule|ShenSongYangXin Capsule 4 granules t.i.d. po for 12weeks
16171512|NCT01612260|Drug|placebo Capsule|4 granules t.i.d. po for 12 weeks
16171513|NCT01612247|Drug|Cyclophosphamide and Methotrexate and Aspirin|Cyclophosphamide 50 mg PO daily x 28 days, cycles 1-4 Methotrexate 2.5 mg PO twice daily, days 1 and 2 each week x 4 weeks, cycles 1-4 ASA: 325 mg PO daily x 28 days, cycles 3 and 4 Treatment will be given for a total of 4 cycles.
16171514|NCT01612234|Dietary Supplement|High palmitate or high oleate diet.|High palmitate diet composition: Fat, 40.4% kcal; palmitic acid, 16.0% kcal; oleic acid,16.2% kcal. High oleate diet composition: Fat, 40.1% kcal; palmitic acid, 2.4% kcal; oleic acid, 28.8% kcal
16171515|NCT01612221|Drug|N-acetylcysteine|N-acetylcysteine (NAC), 1200 mg Oral route 2 doses
16171516|NCT01612221|Other|Placebo arm|Sterile normal saline, diluted into 25 cc tomato juice, orally, x 1 dose. Then repeated 24 hours later.
16171517|NCT01612208|Device|Periarticular Locking Plate (NCB, Zimmer)|The proximal plate segment will be applied to the diaphysis using four 5.0 mm MotionLoc screws. The plate will not be compressed onto the femoral diaphysis to preserve periosteal perfusion and to enable controlled motion between the plate and the diaphysis. If desirable, temporary spacers of the NCB set may be used in the proximal plate segment to facilitate 1-2 mm plate elevation over the diaphysis. Only MotionLoc screws will be used for fixation of the NCB plate proximal to the fracture site.
16171518|NCT01612208|Device|MotionLoc Screw|The NCB Polyaxial Locking Plate System is indicated for temporary internal fixation and stabilization of fractures and osteotomies of long bones. These MotionLoc screws have a reduced 3.4 mm diameter mid-shaft section to bypass the near cortex. By avoiding rigid constraint in the near cortex, the MotionLoc screw design increases the working length of the screw, allowing for elastic flexion of the screw shaft within a controlled motion envelope in the near cortex.
16171519|NCT01612195|Procedure|Anal fistula plug|All patients have a draining seton for at least 6 weeks prior placement of the anal fistula plug. All patients are administered a general anesthetic and are operated in the lithotomy position. The seton is removed, but no curettage or irrigation of the fistula tract is performed. The plug is inserted through the internal opening, and pulled through the external opening until it fit snugly and its base is sutured to the internal sphincter with 2 interrupted 2-0 polyglactin 910 sutures. The tip of the plug is cut at skin level and not sutured. The external opening is left open to allow for drainage. The patient is instructed to restrict physical and sexual activity for 2 weeks postoperatively. Patients are seen in the post-operative clinic at 10 days, 6 weeks and 6 months as per protocol.
16171520|NCT01612182|Other|renal replacement therapy|renal replacement therapy : hemodialysis and/or CRRT(continuous renal replacement therapy )
16171521|NCT01612169|Behavioral|Patient Navigation (PN) Group|The patient navigator approach includes five functions: 1) establishing an effective working relationship; 2) encouraging identification and use of strengths, abilities and assets; 3) supporting client control over goal setting and the search for needed resources; 4) viewing the community as a resource and identifying informal sources of support; and 5) conducting case management as an active community based activity.
16171625|NCT01611376|Device|Niccomo™ (Medis, Ilmenau, Germany) impedance cardiography|
16171626|NCT01611363|Drug|ASP1941|Oral
16171522|NCT01612169|Behavioral|Patient Navigator Plus Contingency Management (PN+CM) Group|Study participants randomized to this group will receive the patient navigation (PN) intervention as outlined above combined with contingency management (CM).
16171523|NCT01612156|Drug|2% lidocaine gel|2% lidocaine gel will be used to coat the urethral catheters and cotton tipped swab before use during the examination.
16171524|NCT01612156|Drug|Water based lubricant|Water based lubricant will be applied to all urethral catheters and cotton tipped swabs before use in the pelvic floor examination.
16171525|NCT01612143|Drug|setrobuvir|200 mg capsule formulation, single oral dose
16171526|NCT01612143|Drug|setrobuvir|200 mg tablet formulation, single oral dose
16171527|NCT01612130|Drug|100 mg of Valeriana officinalis L|A single dose of 100 mg of Valeriana officinalis L., 1 hour prior to surgical procedures
16171528|NCT01612130|Drug|Placebo 100mg|A single dose of 100 mg of placebo orally, 1 hour prior to surgical procedures
16171529|NCT01612104|Behavioral|Psychological First Aid|A cognitive behavioral (CBT) method structuring and focusing psychological therapy sessions with children and adolescents having been exposed to potential trauma
16171530|NCT01612091|Device|Monitoring Messenger|Monitoring Messenger prototype device
16171531|NCT01612091|Device|Traditional tools|Paper based records, screenshots of monitors and therapy devices
16171532|NCT01612078|Drug|Droxidopa|200mg/tab 2tablets, po, three times a week
16171533|NCT01612078|Drug|Placebo|200mg/tab, po, three times a week.
16171534|NCT01612065|Drug|Misoprostol|200 ug
16171535|NCT01612065|Drug|Misoprostol|Misoprostol vaginally, 400 ug
16171536|NCT01612052|Drug|Antibiotic Prophylaxis|Comparing the antibiotic treatment related to surgery
16171537|NCT01612039|Drug|ASP3291|Tablet, 1,000 mg (four 250-mg tablets), twice a day, 8 weeks
16171538|NCT01612039|Drug|Placebo|Matching placebo tablets
16171539|NCT01612026|Procedure|arterial cannulation by angiographic imaging|comparing successful arterial cannulation in case of non-cardiac vascular patient population.
16171540|NCT01612013|Drug|Sodium bicarbonate plus saline|Sodium bicarbonate solution (Sodium bicarbonate 8.4%, Equiplex, Brazil) was given by adding fifteen ampoules of sodium bicarbonate (150 mEq of sodium) to 1 L of 5% dextrose. Infusion in bolus began 60 min prior to the start of contrast administration at 3.5 ml/Kg/h, decreased to 1.18 ml/Kg/h during the contrast exposure and for the next 6 hours after the procedure. Saline (0.9 percent) was given IV at a rate of 1 ml/Kg/h over 60 min prior to the start of contrast administration and followed at the same rate during and for the next 6 hours after the procedure.
16171541|NCT01612013|Drug|Intravenous NAC plus saline|Acetylcysteine (Flucistein 100 mg/ml, Neo Química, Brazil) was given via IV bolus at a rate of 150 mg/kg in 500 ml dextrose 5% over 60 min immediately before contrast exposure and followed by 50 mg/kg in 500 ml dextrose 5% during the contrast exposure and for 6 hours after the procedure. Saline (0.9 percent) was given IV at a rate of 1 ml/Kg/h over 60 min prior to the start of contrast administration and followed at the same rate during and for the next 6 hours after the procedure.
16171542|NCT01612013|Drug|NAC plus sodium bicarbonate plus saline|Acetylcysteine was given intravenous at a rate of 150 mg/kg over 60 min before contrast exposure and followed by 50 mg/kg during the contrast exposure and for 6 hours after the procedure. Sodium bicarbonate solution(150 mEq of sodium) was began 60 min prior to the start of contrast administration at 3.5 ml/Kg/h, decreased to 1.18 ml/Kg/h during the contrast exposure and for the next 6 hours after the procedure. Saline was given intravenous at a rate of 1 ml/Kg/h over 60 min prior to the start of contrast administration and followed at the same rate during and for the next 6 hours after the procedure.
16171543|NCT01612013|Drug|Saline|Saline (0.9 percent) was given IV at a rate of 1 ml/Kg/h over 60 min prior to the start of contrast administration and followed at the same rate during and for the next 6 hours after the procedure.
16171544|NCT01612013|Drug|NAC plus saline|Acetylcysteine was given via intravenous bolus at a rate of 150 mg/kg over 60 min immediately before contrast exposure and followed by 50 mg/kg during and for 6 hours after the procedure. Saline (0.9 percent) was given intravenous at a rate of 1 ml/Kg/h over 60 min prior and followed at the same rate during and for the next 6 hours the procedure.
16171545|NCT01612013|Drug|NAC plus sodium bicarbonate plus saline|Acetylcysteine was given intravenous at a rate of 150 mg/kg over 60 min before contrast exposure and followed by 50 mg/kg during and for 6 hours after the procedure. Sodium bicarbonate solution (150 mEq/L of sodium) was given in bolus began 60 min before contrast administration at 3.5 ml/Kg/h, decreased to 1.18 ml/Kg/h during and for the next 6 hours of the procedure. Saline was given intravenous at a rate of 1 ml/Kg/h over 60 min prior to the start of contrast administration and followed at the same rate during and for the next 6 hours after the procedure.
16171546|NCT01612000|Biological|PanBlok|Intramuscular injection
16171547|NCT01612000|Biological|rHA adjuvant|Intramuscular injection
16171548|NCT01611987|Other|MStep|Participant will meet with instructor twice to learn how to exercise safely. Exercises will be demonstrated and practiced under the direct supervision of the instructor. Written details and pictures will be made. Variety in exercise will be encouraged to promote long-term adherence. Stretching, strengthening and relaxation exercises will be given. Persons will be given Thera Band® to facilitate resistance exercise training and instructed how to progress. Equipment such as Nordic Walking Poles, stationary bicycle, BOSU®, or exercise balls will be available. Rather than having a fixed rigid prescription, the aim is to get people to intuitively adjust the amount of resistance so they feel they are working without causing harm, they are not doing the same boring activity, week in week out.
16171549|NCT01611987|Other|General guideline approach|Individuals in the control condition will meet with the exercise instructor on two occasions during the first two weeks to review key components of public health guidelines for physical activity and health. In brief, the general guidelines for MS are (i) aerobic and endurance exercise for 30 minutes per session, 3 times per week at an intensity of 60% to 75% of heart rate peak; (ii) weight training for weak muscles, 2 days per week, on non-endurance days, 8 to 15 repetitions per exercise; and (iii) stretching daily with active or passive range of motion exercises, or attendance at Yoga or Tai Chi classes.
16171550|NCT01611974|Drug|Maribavir|Tablet for oral administration
16171551|NCT01611961|Drug|DT-LM|Intravenous infusion, Upto 6 dose levels have been studied i.e. 45, 60, 75, 90 105,and 120 mg/m2, Every 3 weeks.
16171552|NCT01611961|Drug|docetaxel|Intravenous infusion, 3 dose levels：60, 75, and 90 mg/m2, Every 3 weeks
16171553|NCT01611948|Drug|Aprepitant|125mg/day for 8 weeks
16171556|NCT01611935|Drug|Vasopressin|After receiving greater than 6 units of blood product within the first 12 hours of admission, trauma patients will be randomized to either normal saline or vasopressin. Subjects will receive an initial 4 unit bolus followed by an infusion of 0 to 0.04 units titrated to maintain a mean arterial blood pressure of equal to or greater than 65 mmHg for a total of 48 hours.
16171557|NCT01611922|Other|Ophthalmic dye|Topically instilled for the purpose of assessing lid margin staining
16171558|NCT01611922|Device|Contact lenses|Silicone hydrogel contact lenses per subject's habitual brand and power, worn for a minimum of 8 hours on the day of assessment, after which lenses will be removed and dye will be instilled.
16171559|NCT01611909|Drug|p-menthane-3,8-diol oil|Apply topically to affected area twice daily
16171560|NCT01611896|Dietary Supplement|Selenium|100 µg tablets. The dose of daily supplement of selenium is set at 200 µg (two tablets). The duration of the intervention period is between 24-30 months. This is defined by the time of ATD treatment withdrawal, which is scheduled between approximately 12-18 months after randomisation. Selenium supplementation will continue 12 months after withdrawal of ATD treatment.
16171561|NCT01611896|Other|Placebo|Placebo tablets, identical in regards to size, appearance, taste, smell, and solubility to the experimental intervention tablet will be produced by Jemo-Pharm A/S, http://www.jemo-pharm.dk/frame.cfm/cms/id=977/sprog=2/grp=6/menu=1/ (content as in section: Auxiliary agents). The placebo regimen will be identical to the selenium regimen, but consist of two non-active tablets per day for 24-30 months.
16171562|NCT01611883|Drug|Ezetimibe|10 mg oral dose once daily for 24 weeks
16171563|NCT01611883|Drug|Placebo|Placebo to match ezetimibe orally once daily for 24 weeks.
16171564|NCT01611857|Drug|Tivantinib|Patients with advanced solid tumors will be treated with oral Tivantinib (120, 240, or 360 mg BID) daily for 14 days in cycles of 14 days.
16171565|NCT01611857|Drug|FOLFOX|The FOLFOX treatment regimen is started on Day 1 of each cycle and consists of 5-Fluorouracil (5-FU) 400 mg/m^2, 5-FU continuous IV 2400 mg/m^2 over 46 hours, leucovorin 400 mg/m^2 IV, and oxaliplatin 85 mg/m^2.
16171566|NCT01611844|Device|Medical device : micro-needle BD 1.5 mm 30G drug:Tubertest® : tuberculin (purified protein derivative)|"2 intradermal injections are performed on each arm/bottom of the subject:
~1 intradermal injection of Tuberculin (5UI)
~1 intradermal injection of saline solution using Manthoux method or BD micro-needle. the method of injection is randomized: left or right"
16171567|NCT01611844|Device|medical device: lance 26G X 16mm drug: Tubertest® : tuberculin (purified protein derivative)|"2 intradermal injections are performed on each arm/bottom of the subject:
~1 intradermal injection of Tuberculin (5UI)
~1 intradermal injection of saline solution using Manthoux method or BD micro-needle. the method of injection is randomized: left or right"
16171568|NCT01611831|Behavioral|ACT in group|A protocol based on the main research studies describing the therapy and adapted for fibromyalgia treatment by our research group will be used. This protocol is available for the investigators. There will be 9 group sessions of 90 minutes duration each. Patients assigned to this arm will be allowed to occasionally take minor analgesics.
16171569|NCT01611831|Behavioral|Improved treatment as usual by General Practitioners|General practitioners (GPs) will administer treatment as usual to the patients with fibromyalgia. To enhance the intervention, the Clinical Guidelines on the Treatment of Fibromyalgia approved by the Health Services of Aragon will be provided to the GPs.
16171570|NCT01611818|Other|Low Intensity Internet-delivered psychotherapy|Patients will be contacted by a researcher trained in psychotherapy. Patients can ask for questions or advice to psychotherapists during the study
16171571|NCT01611818|Other|Self-guided Internet delivered psychotherapy|No contact with the therapists over the treatment period will be done.
16171572|NCT01611818|Other|Improved treatment as usual|Any kind of treatment administered by the GP to the patient with depression
16171573|NCT01611805|Drug|GSK1605786|Opaque Swedish orange body and cap.
16171574|NCT01611805|Drug|GSK1605786 Placebo|Opaque Swedish orange body and cap.
16171575|NCT01611792|Other|Stabilization exercise protocol|The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles as well as deep dorsal trunk muscles. Then patients were progressed to exercises that added leverage of the limbs while maintaining the co-contraction of the deeper abdominal muscles and deep dorsal trunk muscles while breathing normally. Various positions (e.g., supine and quadruped positions) were used to challenge the patients based on their tolerance. Finally, patients were progressed to exercises in more functional positions that included tasks/activities that were reported as challenging and/or painful; patients performed the tasks at the speed demanded by the particular task. Maintenance of the co-contraction of deep trunk muscles was emphasized during these functional activities.
16171576|NCT01611792|Other|Strength and conditioning exercise protocol|This protocol contained trunk strengthening and endurance exercises. It consisted of 3 phases: 1) initial strengthening of trunk flexors/extensors in single plane movements, 2) trunk and lower-extremity stretching as well as progression of trunk-strengthening exercises to include multi-planar trunk movements. Aerobic exercises were progressed as tolerated and patient education about body biomechanics were reinforced, and 3) trunk-strengthening exercises under dynamic conditions (e.g., unstable support surface and in multi-planar trunk movements). During the 10 week protocol, exercises became more challenging, and each subject had to complete at least the first phase before moving onto the next phase in order to be included in post-testing analyses. There was no specific focus on the deep abdominal or deep dorsal trunk muscles during any of these exercises.
16171577|NCT01611779|Device|Encore Tongue Suspension System|The primary components of the Encore Tongue Suspension System consist of a suture passer, suspension line and bone screw.
16171578|NCT01611766|Procedure|Secondary Cytoreductive Surgery|Complete Cytoreduction
16171579|NCT01611766|Drug|Salvage Chemotherapy|6 cycles of postoperative chemotherapy
16171580|NCT01611753|Other|packed red blood cell transfusion|Patients wil be randomized en two groups, in the liberal group they must received transfusions immediately, as the objective was to maintain hemoglobin levels above 9.0 g/dL. In the restrictive group they will receive transfusion to maintain hemoglobin levels above 7.0g/dL
16171581|NCT01611740|Procedure|Analysis of the heart rate and respiratory characteristics / Telemonitoring system prototype developed by INSERM U-642|"Telemonitoring system prototype developed by INSERM U-642 with analysis of :
~the variability of the cardiac cycle duration ;
~the variability of respiratory cycle amplitude and duration ;
~and their relationships."
16171582|NCT01611727|Drug|Cisplatin|Cisplatin chemotherapy will be administered as a 75 mg/m2 intravenous (IV) infusion every 3 weeks, for six cycles. Dexamethasone (8mg) will be administered once daily for three days after chemotherapy. Ondansetron (Zofran™) will be used for anti-nausea prophylaxis.
16171583|NCT01611714|Other|Audit-feedback|Clinicians will receive a short email educational message at regular intervals alerting them to the historic disparities in diagnostic workup for SAH in our department and reminding them of the increased risk of SAH among African-American patients.
16171584|NCT01611714|Other|Clinical Decision Support|"Clinicians receive an embedded real-time Best Practice Alert (BPA) of increased rates of SAH among African-Americans when they open the headache electronic charting template."
16171585|NCT01611701|Procedure|cryoballoon ablation|In Cryo group, 28mm balloon was introduced into the PV ostium with the best possible occlusion of the PV. Every step was controlled by fluoroscopy. Cryoenergy was applied for maximal 6 minutes per application for 2 times, resulting in a circumferential ablation lesion. Before the right superior vein was treated, a quadripolar catheter was placed in the superior vena cava to continuously stimulate the right phrenic nerve during cryoapplication. The application was stopped immediately in the case of diminished diaphragm movements.
16171586|NCT01611701|Procedure|Radiofrequency ablation|n RF group, reisolation of the PV was performed by identifying the breakthrough site. Radiofrequency energy was delivered at 43°C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and was reduced to 43°C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation rate of 17 mL/min. Each lesion was ablated continuously until the local potential amplitude decreased by >80% or RF energy deliveries exceeded 40 s.
16171587|NCT01611688|Drug|NNC0215-0384|I.v.(intravenous) dose-escalation. Highest dose planned for i.v. administration is 10 mg/kg
16171588|NCT01611688|Drug|placebo|Administered i.v.(intravenous) or s.c. (subcutaneous, under the skin).
16171589|NCT01611688|Drug|NNC0215-0384|The s.c. (subcutaneous, under the skin) part will not start until at least two i.v. dose levels have been evaluated for safety and pharmacokinetics. Highest dose planned for s.c. administration is 4 mg/kg
16171590|NCT01611675|Drug|Vemurafenib|take orally, twice daily
16171591|NCT01611675|Drug|Leflunomide|take orally, once daily
16171592|NCT01611662|Drug|gemcitabine hydrochloride|Given IV
16171593|NCT01611662|Drug|cisplatin|Given IV
16171594|NCT01611662|Procedure|therapeutic conventional surgery|Undergo radical cystectomy
16171595|NCT01611662|Other|laboratory biomarker analysis|Correlative studies
16171596|NCT01611649|Dietary Supplement|Formula containing dairy lipids and plant oils|4 months consumption
16171597|NCT01611649|Dietary Supplement|Formula containing plant oils|4 months consumption
16171598|NCT01611649|Dietary Supplement|Formula containing dairy lipids and plant oils, DHA+ARA|4 months consumption, DHA+ARA supplemented formula containing dairy lipids and plant oils
16171599|NCT01611623|Drug|SNX-5422|Tablets dose every other day; dose escalation based on safety
16171600|NCT01611610|Other|Functional tests|"The ambulant patients will perform
~MFM (20 items)
~Hammersmith modified module - MHMFS
~Timed tests (time to rise from the floor,...)
~6 minute walk test
~PedsQL - neuromuscular module"
16171601|NCT01611610|Other|Functional tests|"The non-ambulant patients will perform:
~MFM (20 items)
~Hammersmith modified module - MHMFS
~Upper Limb Functional Items
~Egen Klassifikation 2 questionnaire - EK2
~PedsQL questionnaire - neuromuscular module"
16171602|NCT01611597|Other|Different standardized tasks with an accelerometer device|Patients will perform tests like hand grip (MyoGrip), pinch (MyoPinch), Moviplate, box and block test of hand function, Minnesota Manual Dexterity Test. The tests will be performed with the accelerometer device worn on the wrist.
16171603|NCT01611584|Drug|ALA-induced Fluorescence|ALA Dose- 20 mg/kg
16171604|NCT01611571|Drug|Risedronate|weekly risedronate
16171605|NCT01611571|Drug|Teriparatide|daily teriparatide
16171606|NCT01611571|Drug|Placebo Teriparatide|daily placebo of teriparatide
16171607|NCT01611571|Drug|placebo Risedronate|weekly placebo of Risedronic Acid
16171608|NCT01611558|Biological|Ipilimumab|
16171609|NCT01611545|Genetic|Pharmacogenomics|Utilizing pharmacogenomics to determine the most effective treatment
16171610|NCT01611506|Biological|Cetuximab|"Induction chemotherapy:
~Cetuximab 400mg/m2 (loading dose) on day 1 Cetuximab 250mg/m2 weekly thereafter
~Followed by:
~Cetuximab 250mg/m2 weekly on day 1 during chemoradiation
~Postoperative treatment:
~3 cycles of Cetuximab 250mg/m2 weekly on day 1"
16171611|NCT01611506|Drug|Capecitabine|"Induction chemotherapy:
~Capecitabine 1000mg/m2 twice daily from the evening of day 1 to the morning of day 15 within each 3 weeks cycle
~Postoperative treatment:
~Capecitabine 1000mg/m2 twice daily from the evening of day 1 to the morning of day 15 within each 3 weeks cycle"
16171612|NCT01611506|Drug|Cisplatin|"Induction chemotherapy:
~Cisplatin 80mg/m2 on day 1 of each 21 day cycle
~Followed by:
~Cisplatin 30mg/m2 weekly on day 1 during chemoradiation
~Postoperative treatment:
~Cisplatin 80mg/m2 on day 1 of each 21 day cycle"
16171613|NCT01611493|Device|Osseotite Prevail Implant|Osseotite Prevail will be placed in sites with native bone, with at least three months of healing since tooth extraction or four months from bone augmentation grafting procedure
16171614|NCT01611493|Device|Osseotite Non Prevail Implant|Osseotite Non Prevail Implant will be placed in sites with native bone, with at least three months of healing since tooth extraction or four months from bone augmentation grafting procedure
16171615|NCT01611480|Drug|Imiquimod (topical use)|
16171616|NCT01611467|Drug|CC-223|20 mg oral CC-223 capsule containing a microtracer of [14C]-CC-223 solution
16171617|NCT01611467|Drug|CC-223|20-mg oral CC-223 tablet under fasting or fed conditions
16171618|NCT01611454|Device|XPF thyroid collar|Interventionalist wear the experimental (XPF) thyroid collar during fluoroscopy guided interventions.
16171619|NCT01611454|Device|Standard 0.5mm lead equivalent thyroid collar|Interventionalist wear a standard 0.5mm lead equivalent thyroid collar during fluoroscopy guided interventions.
16171620|NCT01611428|Drug|Ipragliflozin|Oral and Intravenous (i.v.)
16171621|NCT01611415|Drug|Ipragliflozin|Oral
16171622|NCT01611415|Drug|Furosemide|Oral
16171623|NCT01611389|Device|Prolonging atrioventricular (AV) delay.|Prolonging atrioventricular (AV) delay to maximum 350 ms.
16171624|NCT01611389|Device|Standard atrioventricular (AV) delay.|Standard atrioventricular (AV) delay - approximately 180/140 ms depending on heart rate.
16171628|NCT01611350|Other|RCT 1- Testing the Effectiveness of Marketing Messages in Increasing Willingness to Pay|We are testing whether any marketing messages effect participants willingness to pay for the fuel efficient cookstoves. All marketing messages are true.
16171629|NCT01611350|Other|RCT 3-Measure the Effects of Fuel Efficient Cookstoves on Health, Fuel Use and Time Spent Collecting Fuel|Of those who accept the Novel Sales Offer, half the group will be randomly selected to start their free trial early while the other half will receive their free trial late. Those who receive their free trial late will serve as a control group for fuel consumption and Particulate Matter exposure in kitchens.
16171630|NCT01611350|Other|RCT 2- Testing the Effectiveness of the Novel Sales Offer and its ability to Increase Uptake of Purchasing Energy Efficient Cookstoves|We are testing whether households who receive the Novel Sales Offer have higher uptake than those households who receive the Traditional Sales Offer.
16171631|NCT01611337|Other|insight variation measure|insight variation between the firt week of hospitalization and 1 month later
16171632|NCT01611324|Drug|Mepivacaine chlorhydrate 2% in Sodium Bicarbonate 1.4%|4 mL mepivacaine chlorhydrate 20 mg/mL with epinephrine 5 mcg/mL diluted with 16 mL sodium bicarbonate 1.4%
16171633|NCT01611324|Drug|Mepivacaine chlorhydrate 2% with epinephrine in NS 0.9%|4 mL mepivacaine chlorhydrate 20 mg/mL with epinephrine 5 mcg/mL diluted with 16 mL sodium chloride 0.9%
16171634|NCT01611311|Drug|BI 409306 BS|Medium dose film-coated tablet
16171635|NCT01611311|Drug|BI 409306 BS|High dose film-coated tablet
16171636|NCT01611311|Drug|Placebo|Film-coated tablet
16171637|NCT01611298|Biological|Tetanus|"Stem cell transplant donors will receive one dose of tetanus toxoid 0.5mL intramuscularly into deltoid or medial lateral thigh 7-10 days prior to bone marrow or peripheral blood stem cell harvest.
~Stem cell transplant recipients will receive one dose of tetanus toxoid 0.5mL intramuscularly (or subcutaneously if platelet count less than 50,000/uL) into deltoid or medial lateral thigh 7-10 days prior to stem cell transplant (FIRST dose).
~Stem cell transplant recipients will receive a subsequent dose of tetanus toxoid 0.5mL given intramuscularly into deltoid or medial lateral thigh (or given subcutaneously if platelet count is less than 50,000/uL) approximately 3 months following allo stem cell transplant. Patients must meet re-evaluation criteria to receive injection."
16171638|NCT01611259|Drug|Rituximab and Lenalidomide|Rituximab 375 mg/m² i.v. day 1 Lenalidomide 20 mg p.o. daily for 21 days Cycles should be repeated every 28 days. Restaging should be performed after three cycles. In case of at least stable disease, patients should receive another three courses of therapy. Patients with documented CR after 6 courses will stop therapy/study, while patients with PR or SD will be given another two cycles for a maximum of 8 cycles.
16171639|NCT01611246|Device|Iontophoresis System With Earset|iontophoresis of lidocaine-based solution for numbing tympanic membrane
16171640|NCT01611220|Behavioral|RePAN|The dissonance relapse prevention intervention consists of eight groups conducted by a psychologist who involves participants in interactive activities aimed to prevent relapse after discharge from the inpatient treatment
16171641|NCT01611207|Device|Negative Pressure Wound Therapy|KCI. V.A.C. Freedom; Acti V.A.C.; INFO V.A.C. to be used with the V.A.C. Granufoam (black), V.A.C. Granufoam Silver and V.A.C. WhiteFoam Smith & Nephew: Renasys GO and Renasys EZ Plus to be used with the Renassys-F/P and Renassys-G Use of the medical devices and applicable consumption items according to manufacturers guidelines and FDA regulations.
16171642|NCT01611207|Other|Standard Wound Therapy|Standard wound therapy according to current evidence-based guideline (basic and advanced methods of wound treatment)
16171643|NCT01611194|Drug|Hyperbaric oxygen (HBO2) at 1.5 atms|The Hyperbaric oxygen (HBO2) at 1.5 atms (active) group (hyperbaric oxygen-chamber compressed to 1.5 atm abs and breathing 100% oxygen). Each participant should complete 40 sessions over the course of 12 weeks, one session per day, five per week.
16171644|NCT01611194|Drug|Sham control 1.2 atms|The chamber will be compressed with air to 1.2 atm abs to simulate the active group. Participants will don a hood and breathe 21% oxygen (room air). Each participant will complete 40 sessions, one session per day, five sessions per week, within 12 weeks following randomization. Breathing air at a pressure of 1.2 atm abs is equivalent to inhaling 25% oxygen at sea level pressure (1.0 atm abs).
16171645|NCT01611181|Drug|Hemoboost|200 mg specially processed haemoglobin and 30 mg iron dextran equivalent to 10.5 mg organically bound iron in 1 tablet twice daily.
16171646|NCT01611181|Drug|Kräuterblut|40 mg iron, 20 ml twice daily.
16171647|NCT01611181|Drug|Ferrofumerat|200 mg ferrous sulphate as 1 tablet twice daily.
16171648|NCT01611168|Other|Treatment Algorithms|subjects in the intervention group will receive diabetes care from a well-trained registered nurse (RN) who will follow approved treatment algorithms/protocols for glycemia, high blood pressure, lipids and microalbuminuria.
16171649|NCT01611155|Drug|venlafaxine|Given PO
16171650|NCT01611155|Drug|placebo|Given PO
16171651|NCT01611155|Other|questionnaire administration|Ancillary studies
16171652|NCT01611155|Other|quality-of-life assessment|Ancillary studies
16171653|NCT01611142|Biological|KW-0761 (mogamulizumab)|1 mg/kg administered intravenously weekly x 4 then every other week until progression
16171654|NCT01611129|Behavioral|Internet-based counseling|Stage 1 - introduction to the concept of the patient journey and presenting the participants series of questions which may help them to explore their journey through hearing loss; Stage 2 - patient journey model of PHI and 2 case examples will be presented. The PHI will be advised to compare their journey to the model presented and identify the similarities and differences; Stage 3 - communication partners' journey model will be presented and the PHI will be asked to consider how interactions between each other may affect various things in the physical, mental and social domains; and Stage 4 - patients will be encouraged to think about how the PHI & CP may influence each other during their journey through hearing loss, how they can overcome some of the difficulties they may be experiencing and to think about the potential benefits and the challenges from the audiological management.
16171655|NCT01611116|Drug|sodium chloride solution 0.9%|intravenous application added to standard chemotherapy on up to 8 predefined days during the course of study treatment
16171656|NCT01611116|Drug|temsirolimus|intravenous application added to standard chemotherapy on up to 16 predefined days during the course of study treatment
16171657|NCT01611103|Procedure|transcranial direct current stimulation|delivery of transcranial direct current stimulation or sham stimulation for 20 to 60 minutes
16171864|NCT01609335|Drug|F-18 FDG|One time intravenous administration of 17 millicurie (mCi) +/- 10%
16171659|NCT01611090|Drug|Bendamustine hydrochloride|Type=exact number, unit=mg, number=70 mg/m2, route=intravenous use. Administered intravenously on Cycle 1, Days 2-3 and Cycles 2-6, Days 1-2.
16171660|NCT01611090|Drug|Rituximab|Type=exact number, unit=mg, number=375 mg/m2 and 500 mg/m2, route=intravenous use. Administered intravenously on Cycle 1, Day 1, and Cycles 2-6, Day 1, respectively.
16171661|NCT01611090|Drug|Placebo|Form=capsule, route=oral use. Capsule is taken once daily continuously.
16171662|NCT01611077|Drug|Candesartan cilexetil|Candesartan 16 mg tablets p. o. once daily for 14 days, 32 mg tablets once daily for 28 days
16171663|NCT01611077|Drug|Olmesartan medoxomil|Switch to olmesartan 40 mg tablets once daily for 42 days,
16171664|NCT01611077|Drug|Olmesartan/amlodipine|then switch to olmesartan/amlodipine 40/5 mg tablets once daily for 14 days, then olmesartan/amlodipine 40/10 mg tablets once daily for 28 days
16171665|NCT01611064|Drug|Oxygen|Pure oxygen delivered by simple adult oxygen mask at rate of 10 litres/minute. Commencing 3 minutes prior to tourniquet inflation and administered for a maximum of 45 minutes
16171666|NCT01611064|Drug|Medical air|Pure medical air (21% oxygen content) delivered by simple adult oxygen mask at rate of 10 litres/minute. Commencing 3 minutes prior to tourniquet inflation and administered for a maximum of 45 minutes
16171667|NCT01611051|Drug|Drug: Pegylated rhG-CSF: 100µg/kg|Patients were administered pegylated rhG-CSF 100 ug/kg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: EC (epirubicin 100 mg/m2 +cyclophosphamide 600 mg/m2) or ET (epirubicin 75 mg/m2 + docetaxel 75 mg/m2).
16171668|NCT01611051|Drug|Pegylated rhG-CSF: 6mg|Patients were administered pegylated rhG-CSF 6mg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: EC (epirubicin 100 mg/m2 +cyclophosphamide 600 mg/m2) or ET (epirubicin 75 mg/m2 + docetaxel 75 mg/m2).
16171669|NCT01611051|Drug|rhG-CSF 5ug/kg/day|Patients were administered pegylated rhG-CSF 6 ug/kg/day from the 3rd day of every chemotherapy cycle. Chemotherapy regimen: EC (epirubicin 100 mg/m2 +cyclophosphamide 600 mg/m2) or ET (epirubicin 75 mg/m2 + docetaxel 75 mg/m2).
16171670|NCT01611038|Dietary Supplement|Methylselenocysteine|Methylselenocysteine capsule given daily
16171671|NCT01611038|Dietary Supplement|Placebo|Placebo capsule given daily
16171672|NCT01610999|Drug|Plerixafor|Plerixafor will be dosed according to actual body weight. Each dose will be capped at 24 mg (single vial). Plerixafor will be administered subcutaneously according to the assigned cohort starting two hours before the scheduled start of high dose chemotherapy.
16171673|NCT01610986|Dietary Supplement|Glucose-fructose|0.8 g/h glucose and 0.5 g/h fructose during training
16171674|NCT01610986|Dietary Supplement|Water|Only water intake during training
16171675|NCT01610973|Procedure|Endothelial descemet membrane graft|Standard Endothelial descemet membrane graft
16171676|NCT01610973|Procedure|Endothelial descemet membrane graft|Standard Endothelial descemet membrane graft
16171677|NCT01610960|Device|Non invasive ventilation HELMET|The HELMET and HELMET NEXT modes will be tested by each patient.
16171678|NCT01610960|Device|Non invasive ventilation facemask (Respironics)|The facemask Respironics (Herrsching, Germany) will be used by each patient.
16171681|NCT01610934|Drug|liraglutide|The initial daily dose will be 0.6 mg for one week, 1.2 mg the following week and then 1.8 mg for the remaining treatment period. Patients who, due to adverse events, do not tolerate up-titration to 1.8 mg liraglutide will remain on 1.2 mg of liraglutide. The injection is administered once daily in the morning.
16171682|NCT01610934|Drug|Glimepiride|At randomisation patients will be initiated on their pre-study daily dose of glimepiride minus 0.5 mg. After one week the dose will be titrated (see below). Drug naïve patients will be initiated on an initial dosage of glimepiride of 0.5 mg for one week. Thereafter, glimepiride is increased to 1.0 mg and after another one week to 1.5 mg, and there after further up to 3 mg (if the average FPG during one week is above 6 mM). The dose of glimepiride can be increased up to 4 mg if average FPG is above 6 mM and no symptoms of hypoglycaemia are observed.
16171683|NCT01610921|Other|Bronchial provocation test|Provocation tests with adenosine dry powder and nebulized AMP (adenosine-5'monophosphate). The AMP provocation test is a standard test and consists of 14 doubling concentrations in a range of 0.04mg/ml to 320mg/ml. The aerosols will be inhaled during tidal breathing for 2 minutes. The dry powder adenosine also consists of 14 doubling steps with doses in a range of 0.01mg to 20mg.
16171684|NCT01610908|Other|The Schroth exercises treatment|"The Schroth approach consists of 3D scoliosis-specific exercises based on sensorimotor and kinesthetic principles. The goal of Schroth exercises is to teach patients to consciously maintain the correct posture in daily living activities in order to improve the curve, pain, and self-image. To achieve this goal, Schroth exercises focus on endurance and strength training of postural muscles. Schroth exercises also aim to improve posture motor control by repeating corrective movements with progressively less feedback and less passive support.
~Dosage: 5 individual 1-hour long sessions, continued with the daily 45 minutes home exercise program. In addition, patients are required to come weekly for 1-hour long group sessions over the span of 6 months."
16171685|NCT01610908|Other|Global Postural Re-Education|The 6-month supervised Global Postural Re-education intervention involves active movements and postures aimed at realigning joints, stretching shortened muscles and enhancing the contraction of antagonist muscles, thus avoiding postural asymmetry. These postures imply an active participation of the patient. Global Postural Re-education includes eight therapeutic postures, lying, sitting or standing, held for 15/20 min. each. Variously combinations are used during sessions chosen on based on the amount of pain, load capacity, age of the patient, and muscle chains to be stretched. Static and dynamic functions are also employed for about five minutes each sessions to use the recovered flexibility in functional activities Dosage: Weekly individual 1-hour long sessions, with daily 15 minutes home exercise program over 6 months.
16171710|NCT01610622|Device|COstatus cardiac output measurement with isotonic saline|"Isotonic saline, which is the indicator, is injected to obtain COstatus cardiac output measurements.
~No other interventions are made for the purpose of the study."
16171861|NCT01609361|Other|Rehabilitation program|Rehabilitation program including specific anesthetic drugs, post operative fast track recovery (early diet, mobilisation, antalgics)
16171686|NCT01610895|Other|Split-dose PEG Based Lavage (2L + 2L) with Low-Fibre Lunch Dietary instructions|"Patients will be instructed to arrive for colonoscopy at or after 10 AM. Preparation Instructions: At 8pm the day before the colonoscopy drink 2L of PEG within 2 hours. Starting 5 hours before their arrival time on the day of Colonoscopy, drink the remaining 2L of PEG within 2 hours.
~Dietary Instructions: Low fibre diet for 4 days prior to Colonoscopy. The day before Colonoscopy, low-fibre breakfast, a low-fibre lunch by 2 PM (Created from the table of acceptable foods) and then drink clear fluids until after the procedure is completed."
16171687|NCT01610895|Other|Split-dose PEG Based Lavage (2L + 2L) with Standard Dietary Instructions|"Patients will be instructed to arrive for colonoscopy at or after 10 AM.
~Preparation Instructions: At 8pm the day before the colonoscopy drink 2L of PEG within 2 hours. Starting 5 hours before their arrival time on the day of Colonoscopy, drink the remaining 2L of PEG within 2 hours.
~Dietary Instructions: Low fibre diet for 4 days prior to Colonoscopy. The day before Colonoscopy, low-fibre breakfast and then drink clear fluids until after the procedure is completed."
16171688|NCT01610882|Device|Panda first followed by manual pain assessment|Panda is a smart-phone based application designed to assess post-operative pain; manual method involves use of CAS/FPS-R on paper. Panda will be used first, manual method 5 mins later.
16171689|NCT01610882|Device|Manual first followed by Panda pain assessment|Panda is a smart-phone based application designed to assess post-operative pain; manual method involves use of CAS/FPS-R on paper. Manual method will be used first, Panda 5 mins later.
16171690|NCT01610869|Drug|BIBF 1120|Patients will receive either cyclophosphamide (100mg)and oral BIBF 1120 (200mg bd) or cyclophosphamide (100mg) and placebo.
16171691|NCT01610856|Drug|Polyethylene Glycol|4 Litres of polyethylene glycol bowel preparation solution
16171692|NCT01610856|Drug|polyethylene glycol|Polyethylene glycol 4L given in two split doses of 2L each
16171694|NCT01610817|Other|InPAct : Information for Participating Actively in cardiovascular treatment|Educational guide presented by general practitioners to the patients. A first part of the guide contains some information on cardiovascular risk and on the benefits and risks of antihypertensive drugs. A second part of the guide consists of encouraging the patient to take an active part in monitoring of its treatment.
16171695|NCT01610791|Drug|tocilizumab [RoActemra/Actemra]|8 mg/kg iv every 4 weeks, total of 6 infusions
16171696|NCT01610778|Dietary Supplement|Placebo|
16171697|NCT01610778|Dietary Supplement|5-aminolevulinic acid phosphate|
16171698|NCT01610765|Drug|Novel Antiviral Drug|4 oral doses of a Novel Antiviral Drug: 0.25 mg/kg/dose, 0.50 mg/kg/dose, 1.0 mg/kg/dose or 2.0 mg/kg/dose twice a week for 3 weeks during the time in which the 21 day administration of parenteral acyclovir is being administered. Subjects will be assigned a the higher dose of study drug after the DSMB and sponsor determine that reported adverse events and the PK data show that it is safe to increase dosing to the next higher level.
16171699|NCT01610765|Drug|Placebo|4 oral doses of placebo matching the a Novel Antiviral Drug assigned dose: 0.25 mg/kg/dose, 0.50 mg/kg/dose, 1.0 mg/kg/dose or 2.0 mg/kg/dose twice a week for 3 weeks during the time in which the 21 day administration of parenteral acyclovir is being administered. Subjects will be assigned a the higher dose of study drug after the DSMB and sponsor determine that reported adverse events and the PK data show that it is safe to increase dosing to the next higher level.
16171700|NCT01610752|Behavioral|SmartMoms|This intervention will cover many topics to help you learn about weight management during pregnancy. You will be taught how to use different tools provided to help you monitor your weight. We will ask you to record your body weight (using a scale we will provide) as well as your food intake and exercise habits.
16171701|NCT01610739|Drug|Indigocyanine green dye|Each patient will receive 1 injection of indigocyanine green dye using 2.5 mg/mL concentration of the imaging agent. 3mL of this mixture will be injected intravenously, followed by 10mL NS bolus, just prior to imaging with the SPY scope
16171702|NCT01610726|Procedure|Enhanced versus conventional recovery in colorectal surgery|Enhanced recovery (extended informations to the patients, change of anesthetic procedure, intravenous versus gas, and intensified mobilisation) versus conventional recovery
16171703|NCT01610713|Drug|GW-1000-02|Containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. The maximum permitted dose of study medication was eight actuations (22 mg THC and 20 mg CBD) in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
16171704|NCT01610700|Drug|GW-1000-02|Containing THC (27 mg/ml):CBD (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. The maximum permitted dose of study medication was eight actuations (22 mg THC and 20 mg CBD) in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
16171705|NCT01610700|Drug|Placebo|Each actuation of placebo delivered the excipients only.
16171706|NCT01610687|Drug|GW-1000-02|Contained THC and CBD as extract of Cannabis sativa L. Each 100 μl actuation delivered a dose containing 2.7 mg THC and 2.5mg CBD. The maximum permitted dose was eight actuations (22 mg THC and 20 mg CBD) in any three hour period, and 48 actuations (130 mg THC and 120 mg CBD) in any 24 hour period.
16171707|NCT01610674|Other|Tailored improvement strategy|"A step-wise implementation model is applied:
~1) recommendations on optimal perioperative diabetes care (e.g. the administration of intravenous insulin, encouragement of diabetes self-management) are systematically translated into quality indicators; 2a) using these quality indicators, current care is measured by performing a medical record search among 400 patients in 6 hospitals; 2b) barriers and facilitators for optimal care are measured by performing interviews with professionals 3) based on this information an implementation strategy is developed; 4) implementation activities are enacted in 3 hospitals and 5) evaluated in a controlled before-after design in 6 hospitals providing before and after intervention 400 patients."
16171708|NCT01610661|Other|Diet|Unrefined-carbohydrate refers to foods made with 100% whole grains (wheat, rice, corn). Refined-carbohydrate refers to foods made with white flour (e.g., bread, pasta) or white rice. Simple-carbohydrate refers to foods made with sucrose (50% glucose/50% fructose) and high-fructose corn syrup.
16171709|NCT01610635|Other|Reduced versus standard intervals between blood donations|Over a period of two years participants will be invited to give blood either at usual donation intervals or more frequently. Men will be invited to donate every 12, 10 or 8 weeks and women every 16, 14 or 12 weeks.
16171862|NCT01609348|Drug|Placebo|Capsule matching active drug to be taken once a day for 12 weeks
16171711|NCT01610609|Behavioral|Population Health Management Intervention|"This intervention includes:
~Care manager led patient education to promote increased patient awareness of personal cardiovascular disease (CVD) risk and
~Care manager led patient outreach to facilitate the treatment of eligible and appropriate patients with statins for primary CVD prevention"
16171712|NCT01610596|Drug|Halobetasol Propionate Lotion 0.05%|Apply twice daily for 1-2 weeks, not to exceed 50 grams per week
16171713|NCT01610596|Drug|Placebo|
16171714|NCT01610570|Drug|Mithramycin|Phase I Portion: Mithramycin will be administered in escalating doses to children and adolescents intravenously over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression. If maximum tolerated dose (MTD) in this Phase differs from the recommended adult dose for Phase II, the protocol will be amended. Using a Simon two stage design, mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults with Ewing sarcoma with Ewings sarcoma - friend leukemia integration 1 transcription factor (EWS-FLI1) fusion transcript Both Phases will enroll patients simultaneously. Phase II Portion: mithramycin will be administered intravenously at 17.5 microgram/kg over 6 hours once daily for 7 days to be repeated every 28 days until unacceptable toxicity or disease progression to children and adults.
16171715|NCT01610557|Drug|Ranibizumab|"Series of three intravitreous injections of ranibizumab (0.3 mg)* or bevacizumab (1.25 mg) administered every 4 weeks for three 12-week periods. Following this crossover phase, eyes received ranibizumab or bevacizumab to which they were originally assigned and treated on an as-needed basis until study completion.
~*Eleven doses of ranibizumab 0.5 mg were given to participants at the start of the study; after FDA approval of the 0.3 mg dose for DME, the protocol was amended and 0.3 mg was used for the remainder of the study (98% of all injections)."
16171716|NCT01610557|Drug|Bevacizumab|"Series of three intravitreous injections of ranibizumab (0.3 mg)* or bevacizumab (1.25 mg) administered every 4 weeks for three 12-week periods. Following this crossover phase, eyes received ranibizumab or bevacizumab to which they were originally assigned and treated on an as-needed basis until study completion.
~*Eleven doses of ranibizumab 0.5 mg were given to participants at the start of the study; after FDA approval of the 0.3 mg dose for DME, the protocol was amended and 0.3 mg was used for the remainder of the study (98% of all injections)."
16171717|NCT01610544|Drug|3'-deoxy-3'-18F fluorothymidine (FLT)|
16171718|NCT01610544|Other|PET/CT scan|
16171719|NCT01610531|Other|SAMScore questionnaire|Patients assessed at high risk according to the SAMScore
16171720|NCT01610518|Dietary Supplement|oat beta-glucan|4g dose for each arm of trial. Form (volume and viscosity) varies between arms. 2h acute trial beginning between 8 and 10 am. Minimum 1 day wash out between arms.
16171721|NCT01610518|Dietary Supplement|Placebo|Control without beta-glucan. Form (volume) varies between arms. 2h acute trial beginning between 8 and 10 am. Minimum 1 day wash out between arms.
16171722|NCT01610492|Drug|belimumab|10mg/kg administered intravenously
16171723|NCT01610479|Drug|TAS-114 + S-1|
16171724|NCT01610466|Procedure|Laparoscopic bariatric surgery ex-vivo training curriculum|The training curriculum will consist of a cognitive, technical and non-technical components. Cognitive component will consist of self-directed readings and a faculty-led seminar. Technical component will consist of training to proficiency on cadaveric porcine laparoscopic jejunojejunostomy and gastrojejunostomy models. Non-technical component will consist of an introductory lecture on non-technical skills in surgery and a simulated crisis scenario with a debriefing session.
16171725|NCT01610453|Procedure|ultrasound examination|transabdominal and transperineal ultrasound examinations
16171726|NCT01610440|Biological|human umbilical cord mesenchymal stem cells|rehabilitation therapy plus human umbilical cord mesenchymal stem cells
16171727|NCT01610427|Procedure|Blood sample collection|Blood samples will be collected in all subjects at two time points, at the Screening Visit (Day 0) and at the Sample Collection Visit (Day 15)
16171728|NCT01610414|Biological|Herpes Zoster vaccine GSK1437173A|2 doses administered intramuscularly (IM) in deltoid region of non-dominant arm
16171729|NCT01610414|Biological|Placebo|2 doses administered IM in deltoid region of non-dominant arm
16171730|NCT01610401|Drug|Metformin|metformin 500 mg three times a day, for 3 days
16171731|NCT01610401|Drug|Pretreatment with metformin in combination of infusion of caffeine.|Pretreatment with metformin 500 mg three times a day for 3 days, in combination with pretreatment with caffeine (4 mg/kg intravenously over 10 minutes) prior to FMD measurement
16171732|NCT01610401|Drug|No pretreatment with metformin in combination with infusion of caffeine|No pretreatment with metformin in combination with pretreatment with caffeine (4 mg/kg intravenously over 10 minutes).
16171733|NCT01610388|Drug|500mg IV GSK1322322/placebo|500mg IV
16171734|NCT01610388|Drug|1000mg oral GSK1322322/placebo|1000mg oral
16171735|NCT01610388|Drug|1000mg IV GSK1322322/placebo|1000mg IV
16171736|NCT01610388|Drug|1500mg oral GSK1322322/placebo dose|1500mg oral
16171737|NCT01610388|Drug|1500mg IV GSK1322322/placebo|1500mg IV
16171738|NCT01610388|Drug|2000mg IV GSK1322322J/placebo|2000mg IV
16171739|NCT01610388|Drug|3000mg IV GSK1322322J/placebo|3000mg IV
16171740|NCT01610388|Drug|1000mg IV GSK1322322J/placebo|1000mg IV
16171741|NCT01610375|Other|Telephone Follow-up|This is a non-randomised observational study to assess the value of a symptom checklist to detect recurrence in women with endometrial cancer. Women will be telephoned using an evidence-based symptom checklist in parallel to the standard clinic-based follow-up. The researcher will call the participants 2 to 5 days prior to their scheduled clinic review dates to enquire about the presence of symptoms which may be indicative of disease recurrence. In addition, the researcher will also enquire about the participants' wellbeing and provide standard lifestyle resource on physical activity, diet and other lifestyle behaviours and supportive care when needed.
16171742|NCT01610362|Biological|Human Rabies Immune Globulin|HRIG 20 IU/kg and 40 IU/kg would be given once to the volunteers on day 0
16171743|NCT01610336|Drug|INC280|During Phase Ib, INC280 was taken at escalating doses. During Phase II part, INC280 was taken at recommended Phase II dose.
16171744|NCT01610336|Drug|Gefitinib|Gefitinib 250 mg taken once daily
16171780|NCT01610024|Dietary Supplement|Beetroot Juice|Give subjects 500ml beetroot juice in the 24 hour period prior to class begins. They will receive this during 3 of the 6 weeks
16171745|NCT01610323|Other|Exercise intervention|Exercise group: 12 weeks of moderate intensity physical training under individual supervision in a specialised conditioning center, with a goal of 3 1h-sessions/week (from 16 wks to 28 wks of gestation). Including aerobic and muscular training.
16171746|NCT01610323|Other|Standard Care|
16171747|NCT01610310|Device|BIIB017 (peginterferon beta-1a) Pre-filled syringe (PFS)|125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by PFS once on either Day 1 or Day 22
16171748|NCT01610310|Device|BIIB017 (peginterferon beta-1a) Autoinjector|125 mcg of peginterferon beta-1a (BIIB017) subcutaneous injection (SC) administered by autoinjector once on either Day 1 or Day 22
16171749|NCT01610297|Drug|ICL670|Oral dose of ICL670 at 10 mg/kg daily
16171750|NCT01610284|Drug|Fulvestrant|Intramuscular fulvestrant 500 mg (Day 1 and Day 15 of Cycle 1 and Day 1 of every cycle thereafter)
16171751|NCT01610284|Drug|BKM120|BKM120 100 mg once daily
16171752|NCT01610284|Drug|BKM120 matching placebo|BKM120 matching placebo, once daily
16171753|NCT01610271|Device|Air Barrier System|ABS is a device that emits a stream of purified air over the surgical site creating a barrier that prevents the intrusion of bacteria.
16171754|NCT01610258|Other|Blood and placenta samples|"The placenta sample is realised, specially for the study, in surgical unit after the delivery.
~The blood samples are taken, specially for the study, the day of admission and at time of delivery or seven days after the admission."
16171755|NCT01610245|Drug|Nitazoxanide|
16171756|NCT01610245|Drug|Oseltamivir|
16171757|NCT01610245|Drug|Placebo Oral Tablet|
16171758|NCT01610245|Drug|Placebo Oral Capsule|
16171759|NCT01610232|Device|Photon stimulation by light-emitting diodes (LEDs)|Treadmill training with the application of the phototherapy was performed twice a week for 6 months, each session lasting 45 min at intensities between 85% and 90% maximal heart rate. The average power and power density on the skin were 100 mW and 39 mW/cm2, respectively. The treatment time was 45 min bilaterally in both thighs. These parameters led to an approximate fluence of 108 J/cm2.
16171760|NCT01610232|Other|Treadmill training|Treadmill training without the application of the phototherapy was performed twice a week for 6 months, each session lasting 45 min at intensities between 85% and 90% maximal heart rate
16171761|NCT01610219|Behavioral|Lifestyle Modification for Type 2 Diabetes Prevention|Family based behavioral intervention utilizing Traffic Light Diet, self monitoring, goal setting, reinforcement and a tool kit containing physical activity-promoting items
16171762|NCT01610219|Other|Nutrition and Physical Activity|This family based education program provided information on physical activity and healthy eating for parents and children.
16171763|NCT01610206|Drug|Gemcitabine|Patients will receive gemcitabine 1000 mg/m2 administered weekly on days 1 and 8 (30 minutes IV infusion) of each cycle for up to 6 cycles. Each cycle is 21 days.
16171764|NCT01610206|Drug|pazopanib|Patients will receive pazopanib 800mg PO daily on days 1-21 of treatment cycles
16171765|NCT01610193|Procedure|Appendicectomy|Also known as appendectomy, surgical removal of the appendix. Laparoscopic (single or 4 port), McBurney's incision, mid-line laparotomy, laparoscopic converted to open.
16171766|NCT01610180|Drug|Eltrombopag Olamine|"Initial dose : 50 mg/day for 14 days.
~Next doses:
~If platelet count <60000/µL, increase daily dose by 25 mg to a maximum of 150 mg/day for next 14 days in 14 days courses. If response criteria not met after 14 days of the maximum dose stop treatment (no response).
~If platelet count >60000/µL and ≤200000/µL same dose for the next 14 days.
~If platelet count >200000/µL and ≤400000/µL decrease the daily dose by 25 mg. Wait 14 days to assess the effects of this and any subsequent dose adjustments.
~If platelet count >400000/µL, stop Eltrombopag; increase the frequency of platelet monitoring to twice weekly. Once the platelet count is <150000/µL, reinitiate therapy at a daily dose reduced by 25 mg."
16171767|NCT01610167|Device|NUPRO Classic Prophy Paste|Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
16171768|NCT01610167|Device|NUPRO Sensodyne Prophy Paste with Novamin with fluoride.|Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
16171769|NCT01610167|Device|NUPRO Sensodyne Prophy Paste with Novamin without fluoride.|Abrasive, flavored dental prophylaxis paste for cleaning and polishing teeth.
16171770|NCT01610154|Drug|Sitagliptin|Sitagliptin 100 mg QD for 12 weeks
16171771|NCT01610141|Other|Genotype-guided warfarin dosing|Applying a Pharmacogenetic-guided warfarin dosing algorithm derived from Chinese to determine the daily maintenance dose of warfarin, based on clinical factors (age, sex, body surface area, etc.), and VKORC1, CYP2C9 and CYP4F2 genotypes, to individualize the dosing of warfarin.
16171772|NCT01610141|Other|Non-genotype guided warfarin dosing|A Empiric fixed warfarin dose of 3 mg/day was given to the patients for at least 3 days. Following doses were adjusted according to the INR measurement.
16171773|NCT01610089|Other|stable isotope infusion|"Control subjects: [15N2-ureido] arginine (0.69 mg/kg); [5-13C,4,4,5,5-D4] citrulline (0.18mg/kg); 15N citrulline (0.03mg/kg); 15N sodium nitrate (0.003 mg/kg), [15N][18O3] potassium nitrate (0.03 mg/kg) and [18O][13C]urea (1 mg/kg)over 10 minutes. Followed by a 8-hour infusion of [15N2-ureido] arginine (0.69 mg/kg/hr); [5-13C,4,4,5,5-D4] citrulline (0.18mg/kg/hr), [15N][18O3] potassium nitrate (0.003 mg/kg/hr) and [18O][13C]urea (0.1 mg/kg/hr).
~Citrullinemia type 1 subjects,[15N2-ureido] arginine (4.14 mg/kg); [5-13C,4,4,5,5-D4] citrulline (1.08 mg/kg); 15N citrulline (0.18mg/kg); 15N sodium nitrate (0.003 mg/kg), [15N][18O3] potassium nitrate (0.03 mg/kg) and [18O][13C]urea (1 mg/kg)over 10 minutes, followed by a 8-hour infusion of [15N2-ureido] arginine (4.14 mg/kg/hr); [5-13C,4,4,5,5-D4] citrulline (1.08 mg/kg/hr), [15N][18O3] potassium nitrate (0.003 mg/kg/hr) and [18O][13C]urea (0.1 mg/kg/hr)."
16171774|NCT01610076|Other|Code Status Video|"10 minute video about Code Status"
16171775|NCT01610063|Other|Pharmacogenomic algorithm|Genetic test results for 4 genes were put through algorithm and provided to physician for guidance prescribing medication.
16171776|NCT01610050|Drug|LFA102|
16171777|NCT01610037|Drug|QVA149|QVA149 110/50 µg will be supplied as capsules in blister packs for once daily inhalation using the Novartis Concept1 SDDPI
16171778|NCT01610037|Drug|Tiotropium|Tiotropium 18 µg will be supplied as capsules in blister packs for once daily inhalation using the HandiHaler SDDPI
16171779|NCT01610037|Drug|placebo|placebo to QVA149A and Tiotropium will be supplied in the appropriate capsule in blister packs for use in either the Novartis Concept1 SDDPI or the HandiHaler SDDPI
16171863|NCT01609348|Drug|Venlafaxine|225 mg daily for 12 weeks
16171781|NCT01610011|Dietary Supplement|Glycine administration|Glycine will be administered once as a 250 cc lemon-flavored beverage based on each subject's body weight. The drink concentration will be 0.4 g/kg glycine (not to exceed 30 grams). Subjects will have 10 minutes to consume the beverage.
16171782|NCT01609998|Biological|Seasonal Influenza DNA vaccine|VRC-FLUDNA063-00-VP is composed of 3 closed-circular DNA plasmids that encode for the hemagglutinin (HA) from the following 3 strains: A/California/04/2009 (H1); A/Victoria/361/2011 (H3), and B/Wisconsin/2010. DNA vaccine vials will be supplied at 4 mg/mL in single use vials. The 1 mg dosage is administered as 0.25 mL volume and the 4 mg dosage as a 1 mL volume.
16171783|NCT01609998|Biological|TIV|2012/13 Seasonal Influenza Trivalent Inactivated Vaccine (TIV)
16171784|NCT01609972|Device|Spinal Cord Stimulator|Non-inferior comparison of implantable spinal cord stimulators
16171785|NCT01609959|Drug|Azilsartan|Azilsartan 20 mg or 40 mg (if blood pressure does not reach the target after 6 weeks) per day for 12 weeks
16171786|NCT01609959|Drug|Valsartan|Valsartan 160 mg per day
16171787|NCT01609946|Device|Realtime-Elastography, linear ultrasound probe, Hitachi EUB-900, Japan|
16171788|NCT01609946|Procedure|Cytology (FNAB) or Surgery|
16171789|NCT01609933|Drug|ABT-450/r|ABT-450 (tablets) dosed with ritonavir (capsules or tablets)
16171790|NCT01609933|Drug|ABT-267|ABT-267 (tablets)
16171791|NCT01609933|Drug|pegylated interferon alpha-2a (pegIFN)|pegIFN alpha-2a (syringe)
16171792|NCT01609933|Drug|Ribavirin (RBV)|Ribavirin (tablets)
16171793|NCT01609920|Drug|Gadofosveset enhanced MRL of axillary lymph nodes|A MRL of the axilla will be performed before and after administration of a single IV bolus injection of gadofosveset of an equivalent of 0.03 mmol Gd/kg body weight at an injection speed of 1.5 mL/sec., followed by a saline flush of 25 mL at an injection speed of 1.5 mL/sec.
16171794|NCT01609907|Drug|Rosuvastatin+Valsartan (Sequence 1)|Period 1(A) Period 2(B) Period 3(C) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)
16171795|NCT01609907|Drug|Rosuvastatin+Valsartan (Sequence 2)|Period 1(C) Period 2(A) Period 3(B) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)
16171796|NCT01609907|Drug|Rosuvastatin+Valsartan (Sequence 3)|Period 1(B) Period 2(C) Period 3(A) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)
16171797|NCT01609907|Drug|Rosuvastatin+Valsartan (Sequence 4)|Period 1(C) Period 2(B) Period 3(A) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)
16171798|NCT01609907|Drug|Rosuvastatin+Valsartan (Sequence 5)|Period 1(B) Period 2(A) Period 3(C) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)
16171799|NCT01609907|Drug|Rosuvastatin+Valsartan (Sequence 6)|Period 1(A) Period 2(C) Period 3(B) A: Rosuvastatin 20mg (once daily for 4 consecutive days), B: Valsartan 160mg (once daily for 4 consecutive days), C: Rosuvastatin 20mg plus Valsartan 160mg (once daily for 4 consecutive days)
16171800|NCT01609894|Dietary Supplement|Individualized fortification of breast milk|"Lactose, fat and protein content will be measured prior to breast milk fortification.
~Subsequently, breast milk for preterm infants will individually fortified adjusted by using data from milk analysis."
16171801|NCT01609894|Dietary Supplement|Routine fortification of breast milk|Infants will be fed routine fortified breast milk.
16171802|NCT01609881|Drug|Acuvail|Dosing of drug 3 days prior to surgery
16171803|NCT01609881|Other|Placebo|Artificial tears qid for 3 days preoperatively
16171804|NCT01609868|Dietary Supplement|Powder protein modular|Infants will receive powder protein modular to achieve 4 grm/kg/day
16171805|NCT01609868|Dietary Supplement|Liquid protein modular|Infants will receive a commerically avaliable liquid protein modular to provide 4 grm/kg/day
16171806|NCT01609855|Drug|Hyoscine Butyl Bromide 20mg/2 ml i.v.|Hyoscine Butyl Bromide 20mg/2 ml i.v.is administered at time of caecal intubation
16171807|NCT01609855|Drug|Saline 2 ml i.v.|Administration of Saline 2 ml at time of caecal intubation
16171808|NCT01609842|Other|Multifaceted Intervention with pharmacist and IVR|An alerted inpatient pharmacists will bring the clopidogrel medication to the patient who has received a stent. The patient will return home and receive IVR messages about the importance of their medication as well as a refill reminder call.
16171809|NCT01609829|Procedure|SAFE (situation, all together, fly on, evaluate)|Video-assisted, structured debriefing after simulated critical airway-events.
16171810|NCT01609816|Drug|Dasatinib|Patients receive dasatinib PO every day (QD) for 6 months.
16171811|NCT01609803|Other|laboratory biomarker analysis|Correlative studies
16171812|NCT01609790|Biological|Bevacizumab|Given IV
16171813|NCT01609790|Other|Laboratory Biomarker Analysis|Correlative studies
16171814|NCT01609790|Other|Pharmacological Study|Correlative studies
16171815|NCT01609790|Other|Placebo Administration|Given IV
16171816|NCT01609790|Biological|Trebananib|Given IV
16171817|NCT01609777|Procedure|SBAR|situation, background, assessment, recommendation
16171818|NCT01609764|Behavioral|One year fitness training|Regular training schedule of moderate intensity, at 50% of heart rate reserve, as available for the specific age group in fitness centres
16171819|NCT01609751|Dietary Supplement|Yakult|62 ml dose daily for 365 days. There must be a cold chain from supplier (Yakult UK) via the primary care centre to the trial participants.
16171820|NCT01609738|Device|Left ventricular septum pacing lead|A left ventricular septum pacing lead is permanently placed by introducing a custom lead with extended helix transvenously and, after positioning it against the RV septum, driving it through the inter-ventricular septum into the LV endocardial layer.
16171821|NCT01609725|Device|Subgingival scaling and root planing|Oral hygiene instruction and motivation will be provided altogether with scaling and root planing of all teeth affected by periodontitis under local anesthesia
16171822|NCT01609725|Device|Oral prophylaxis|One session of supraginigval calculus removal
16171943|NCT01608737|Drug|PegIFN/RBV|PegIFN/RBV for 48 weeks
16171823|NCT01609712|Procedure|Radiofrequency Kyphoplasty|"Radiofrequency kyphoplasty is a new form of surgical treatment. It injects an ultrahigh viscosity cement into the fractured vertebral body, using radiofrequency to achieve the proper consistency of the cement. This ultrahigh viscosity cement is designed to first restore proper height and alignment to the fractured vertebra and then to stabilize the fracture, thereby preventing further intravertebral motion and reducing pain.
~The RF-Kyphoplasty is standard of care in our hospital. It is FDA and CE approved."
16171824|NCT01609699|Device|Treatment with Contour I-Y system|The Contour I - Y System is a non-invasive focused ultrasound, for body contouring purposes, designed to selectively disrupt sub-dermal fat cells at a designated focus employing focused ultrasound. All other types of tissue, such as blood vessels, muscles and peripheral nerves remain intact. There are no thermal effects. Fat cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time.
16171825|NCT01609699|Device|Treatment with Contour I-Y system|The Contour I - Y System is a non-invasive focused ultrasound, for body contouring purposes, designed to selectively disrupt sub-dermal fat cells at a designated focus employing focused ultrasound. All other types of tissue, such as blood vessels, muscles and peripheral nerves remain intact. There are no thermal effects. Fat cell destruction is achieved by ultrasound-induced mechanical effects during a very short exposure time.
16171826|NCT01609673|Drug|Everolimus|"On the day of conversion (day 1), 2 mg everolimus will be introduced in the morning and at night, as morning dose of CsA or Tac will be maintained and evening dose of CsA or Tac will be reduced by 50%.
~In two days, 2 mg everolimus will be associated with 50% of CsA or Tac original dosage, both in the morning and evening. After that, everolimus dose will be adjusted to achieve a C0 target level of 6-10 ng/mL. Once target levels of everolimus are met, the CNI drug will be suspended."
16171827|NCT01609660|Dietary Supplement|Saccharomyces boulardii|100mg daily for seven days prior to surgery
16171828|NCT01609647|Drug|Prasugrel|Reloading with prasugrel 20mg and followed by daily administration of prasugrel 5mg for 30 days
16171829|NCT01609647|Drug|Clopidogrel|Reloading with clopidogrel 300mg and followed by daily administration of clopidogrel 75mg for 30 days
16171833|NCT01609621|Device|Retrograde tibiopedal arterial access|Retrograde, percutaneous arterial access of vessels at or below the tibioperoneal trunk, using a 21 gage needle or micropuncture introducer set, to facilitate crossing and treatment (e.g., angioplasty, stenting, atherectomy) of occlusive arterial lesions in the lower limb.
16171834|NCT01609608|Procedure|whole body vibration|to deliver mechanical oscillation to individuals at various frequencies, amplitudes, and accelerations for different durations. This technique has been applied for years to enhance strength, and improve bone mineral density and balance
16171835|NCT01609595|Drug|sodium 2,2 dimethylbutyrate|Oral capsule, dose 20 mg/kg/day, daily, for 26 weeks
16171836|NCT01609582|Drug|TAK-875|TAK-875 tablets
16171837|NCT01609582|Drug|TAK-875 Placebo|TAK-875 placebo-matching tablets
16171838|NCT01609556|Drug|Mirvetuximab soravtansine|Mirvetuximab soravtansine IV infusion will be administered as per dose and schedule specified in the respective arms.
16171839|NCT01609543|Drug|erlotinib [Tarceva]|150 mg orally daily, until disease progression, unacceptable toxicity or withdrawal due to any reason
16171840|NCT01609530|Procedure|Liquid Nitrogen Cryotherapy|Every two weeks for a total of 5 treatments or until the patient clears, patients in the cryotherapy arm will be treated with 5-7 seconds of freeze time maintaining a 1mm freeze halo around the wart.
16171841|NCT01609530|Procedure|Pulsed 1064nm Nd:YAG|Every 2 weeks for a total of five treatments or until the wart clears, patients in the laser arm will be treated with the Nd:YAG. The settings will be 180J, 20ms pulse width and 5mm spot size. For warts 3mm or less, a 3mm spot size will be used, 180J and 15ms. If the patient reports no response after treatment, including crusting or blistering, the energy will be increased by 10 J until 200J has been reached.
16171842|NCT01609517|Drug|Spinal anesthesia (heavy bupivacaine)|Spinal anesthesia with heavy bupivacaine of 6, 7, 8, 9, 10, 11 mg
16171843|NCT01609504|Procedure|ELRR BY TEM|The surgical technique of ELRR was as follows: mucosal incision included all the tatoo spots performed at admission staging, in order to excise a minimum of 1 cm of normal mucosa around the tumor, according to its diameter before NT
16171844|NCT01609504|Procedure|LTME|LAPAROSCOPIC TOTAL MESORECTAL EXCISION INCLUDING MESORECTAL (ACCORDING TO HEALD CRITERIA)
16171845|NCT01609491|Drug|phenylephrine|If the mean arterial pressure drops below 20% of the baseline value and/or below 90 mmHg, a syringe pump with phenylephrine or norepinephrine (depending on randomisation) will be started. The anaesthetist will be blinded for the type of vasopressor. Concentrations phenylephrine (20 µg /ml) of Norepinephrine (10 µg/ml) will be used in the syringes
16171846|NCT01609491|Drug|norepinephrine|If the mean arterial pressure drops below 20% of the baseline value and/or below 90 mmHg, a syringe pump with norepinephrine (depending on randomisation) will be started. The anaesthetist will be blinded for the type of vasopressor. Concentrations Norepinephrine (10 µg/ml) will be used in the syringes
16171847|NCT01609478|Drug|indacaterol|indacaterol acetate 75 µg or indacaterol acetate 150 µg delivered via Concept 1 inhaler
16171848|NCT01609478|Drug|placebo|placebo delivered via Concept 1 inhaler
16171849|NCT01609478|Drug|mometasone furoate|via Twisthaler inhaler
16171850|NCT01609452|Biological|Blisibimod|
16171851|NCT01609452|Other|Placebo|
16171852|NCT01609439|Drug|Vitamin D|Vitamin D 800 units for 4 weeks preoperatively
16171853|NCT01609439|Drug|Placebo|Placebo
16171854|NCT01609426|Genetic|DNA chip dedicated to the pharmacogenetic of steroids|direct DNA extraction from peripheral blood cells
16171855|NCT01609413|Dietary Supplement|AlgaeCal|One dose equals 3 times 180 mg of calcium, to be taken one time on the morning of the examination day.
16171856|NCT01609413|Dietary Supplement|Caltrate 600|One dose equals 1 capsule of 600 mg calcium, to be taken one time on the morning of the examination day.
16171857|NCT01609387|Dietary Supplement|Fit For me|
16171858|NCT01609387|Dietary Supplement|Davitamon|
16171859|NCT01609374|Device|M6-C Artificial Cervical Disc|Total disc replacement
16171865|NCT01609335|Drug|C-11 PiB|One time intravenous administration of 10-20 mCi
16171866|NCT01609322|Behavioral|Activity, Balance, Learning, and Exposure|An in-home intervention that integrates exposure therapy with cognitive restructuring, exercise, and a home safety evaluation.
16171867|NCT01609322|Behavioral|Fall prevention education|In-home, individual sessions with a health educator regarding fall prevention
16171868|NCT01609309|Procedure|Laparoscopic gastrectomy|"After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, laparoscopic distal subtotal gastrectomy and D2 lymph node dissection will be performed with curative treated intent.
~The type of reconstruction will be selected according to the surgeon's experience and anastomotic procedure is performed extracorporeally using a mini-laparotomy."
16171869|NCT01609309|Procedure|Open gastrectomy|"After exclusion of T4b, bulky lymph nodes, or distant metastasis case by diagnostic laparoscopy, open distal subtotal gastrectomy and D2 lymph node dissection will be performed with curative treated intent.
~The type of reconstruction will be selected according to the surgeon's experience."
16171870|NCT01609296|Device|IN.PACT Admiral™ Drug Eluting Balloon|IN.PACT Admiral™ percutaneous transluminal angioplasty (PTA) paclitaxel drug eluting balloon.
16171871|NCT01609283|Biological|autologous mesenchymal stem cells|"There will be five treatment groups of up to five patients each. Groups 1, 2 and 4 will receive a single dose of cells. Groups 3 and 5 will receive 2 doses of cells separated by one month. Intrathecal injections into new subjects will be timed so that there is a minimum of one week between subject injections. The cell dose per group is as follows:
~Group 1: single intrathecal dose of 1 x 107 cells
~Group 2: single intrathecal dose of 5 x 107 cells
~Group 3: one intrathecal dose of 5 x 107 cells followed one month later by a second intrathecal dose of 5 x 107 cells
~Group 4: single intrathecal dose of 1 x 108 cells
~Group 5: one intrathecal dose of 1 x 108 cells followed one month later by a second intrathecal dose of 1 x 108 cells"
16171872|NCT01609270|Device|CardioRoot graft|prospective single arm multi-center study to evaluate CardioRoot grafts implanted in a thoracic position.
16171873|NCT01609257|Biological|Norovirus Bivalent Vaccine|2 doses IM 28 days apart
16171874|NCT01609257|Biological|Saline Comparator|2 doses IM 28 days apart
16171875|NCT01609244|Device|Bilevel therapy (somnovent ST 22, Weinmann, Hamburg, Germany)|nighttime positive airway therapy for 6 weeks
16171876|NCT01609244|Device|servoventilation (Somnovent CR, Weinmann, Hamburg, Germany)|nighttime positive airway therapy for 6 weeks
16171877|NCT01609231|Drug|Dalotuzumab|Dalotuzumab will be administered intravenously after the completion of irinotecan infusion at a dose of 10 mg/kg once weekly.
16171878|NCT01609231|Drug|Irinotecan|Irinotecan 180 mg/m^2 will be administered intravenously once every two weeks either prior to dalotuzumab (Arm A) or after cetuximab (Arm B). Pre-medication at the discretion of the investigator will follow local or country-specific standard of care.
16171879|NCT01609231|Drug|Cetuximab|Cetuximab will be administered intravenously prior to irinotecan at an initial dose of 400 mg/m^2 followed by weekly infusions of 250 mg/m^2. Pre-medication at the discretion of the investigator will follow local or country-specific standard of care.
16171880|NCT01609218|Drug|LY2140023|
16171881|NCT01609218|Drug|Aqueous activated charcoal|
16171882|NCT01609205|Biological|Adalimumab|Adalimumab 40 mg eow (totally 27 doses/patient) manufactured by Abbott will be distributed as add-on therapy to DMARD
16171883|NCT01609192|Drug|Hydrea® (hydroxyurea )|treatment by hydroxyurea (20-30 mg/kg/day) for 6 months
16171884|NCT01609179|Drug|IPI-926|IPI-926 is administered orally as a capsule formulation, as a fixed dose in mg/day. Patients will be administered the same dose with same cycle length of IPI-926 and combination therapy that they were receiving in the original protocol at the time of transition into the extension study. The following are potential once-daily doses that patients are receiving in original protocols: 60 mg, 90 mg, 100 mg, 110 mg, 130 mg, or 160 mg.
16171885|NCT01609166|Drug|Allopurinol|Allopurinol 3% cream application in one side of the body, twice a day for 6 months
16171886|NCT01609166|Drug|Placebo|Placebo cream application in the other side of the body, twice a day for 6 months
16171887|NCT01609153|Drug|Olanzapine|Coated tablet 5-20 mg milligram(s) per day for 16 weeks
16171888|NCT01609153|Drug|Amisulpride|200-800 mg milligram(s)per day for 16 weeks
16171889|NCT01609153|Drug|Olanzapine and Amisulpride|"Zyprexa:
~Coated tablet 5-20 mg milligram(s) per day for 16 weeks
~Amisulpride:
~Coated tablet 200-800 mg milligram(s)per day for 16 weeks"
16171890|NCT01609140|Drug|MPSK3169A|Dose regimen A, repeating subcutaneous injections every 4 weeks
16171891|NCT01609140|Drug|MPSK3169A|Dose regimen E, repeating subcutaneous injections every 4 weeks
16171892|NCT01609140|Drug|MPSK3169A|Dose regimen D, repeating subcutaneous injections every 4 weeks
16171893|NCT01609140|Drug|MPSK3169A|Dose regimen C, repeating subcutaneous injections every 4 weeks
16171894|NCT01609140|Drug|MPSK3169A|Dose regimen B, repeating subcutaneous injections every 4 weeks
16171895|NCT01609140|Drug|Placebo|Repeating subcutaneous injections of placebo every 4 weeks
16171896|NCT01609127|Drug|Tesetaxel|Tesetaxel 27 mg/m2 orally once on Day 1 of each 21-day cycle
16171897|NCT01609127|Drug|Tesetaxel|Tesetaxel 15 mg/m2 orally once every 7 days for 3 consecutive weeks on Day 1, Day 8, and Day 15 of each 28-day cycle
16171898|NCT01609127|Drug|Capecitabine|Capecitabine 1250 mg/m2 orally twice daily (in the morning and evening after a meal; equivalent to a total daily dose of 2500 mg/m2) on Day 1 through Day 14 of each 21-day cycle
16171899|NCT01609101|Device|C-MAC ® videolaryngoscope|C-MAC ® videolaryngoscope
16171900|NCT01609101|Device|Coopdech® videolaryngoscope|Coopdech® videolaryngoscope
16171901|NCT01609101|Device|McGrath® Series 5 videolaryngoscope|McGrath® Series 5 videolaryngoscope
16171902|NCT01609101|Device|Glidescope® Cobalt videolaryngoscope|Glidescope® Cobalt videolaryngoscope
16171903|NCT01609101|Device|King Vision® videolaryngoscope|King Vision® videolaryngoscope
16171904|NCT01609101|Device|Venner® videolaryngoscope|Venner® videolaryngoscope
16171905|NCT01609101|Device|McGrath® MAC|McGrath® MAC (Aircraft Medical, Edinburgh, UK)
16171906|NCT01609088|Dietary Supplement|Erythritol-containing beverage|Orange flavored beverage containing erythritol
16171907|NCT01609062|Drug|BMN 110|Weekly IV infusions of BMN 110 at 2.0 mg/kg/week over a period of approximately 4 hours per infusion for up to 192 weeks.
16171944|NCT01608737|Drug|BI 201335|BI 201335 once daily low dose for 24 weeks
16171908|NCT01609062|Drug|BMN 110|Weekly IV infusions of BMN 110 at 4.0 mg/kg/week over a period of approximately 4 hours per infusion for 27 weeks, and will eventually transition to 2.0 mg/kg/week for up to an additional 166 weeks.
16171909|NCT01609049|Drug|Peginterferon alfa-2a|Administration of treatment will be according to local recommendation under local labeling.
16171910|NCT01609049|Drug|Ribavirin|Ribavirin tablets twice daily orally will be administered depending on body weight, according summary product characteristics and prescribing of ribavirin in real clinical practice.
16171911|NCT01609023|Drug|Rituximab|Rituximab will be administered in combination with chemotherapy according to SPC and routine clinical practice.
16171912|NCT01609010|Drug|rituximab|375 mg/m2 rituximab i.v. weekly for 4 weeks
16171913|NCT01609010|Drug|interferon-a-2a|3 MIU/day interferon-a2a s.c. during Week 1, and 4.5 MIU/day s.c. 6 days per week during Weeks 2 through 5
16171914|NCT01608984|Procedure|Remote ischemic preconditioning (RIPC)|"3 cycles of 5 min left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 min reperfusion.
~The applied anesthesia protocol avoids the use of propofol. Drugs: isoflurane+sufentanil anesthesia Anaesthesia is maintained by inhaled isoflurane in concentrations 0.7-0.8 % end-tidal with additional sufentanil injected during surgery, as required. In the CABG-arms, during extracorporal circulation patients receive isoflurane via a vaporizer incorporated in the extracorporeal gas supply in the same concentrations."
16171915|NCT01608984|Procedure|Coronary artery bypass grafting (CABG) without remote ischemic preconditioning protocol|The applied anesthesia protocol avoids the use of propofol. Drugs: isoflurane+sufentanil anesthesia Anaesthesia is maintained by inhaled isoflurane in concentrations 0.7-0.8 % end-tidal with additional sufentanil injected during surgery, as required. During extracorporal circulation patients receive isoflurane via a vaporizer incorporated in the extracorporeal gas supply in the same concentrations.
16171916|NCT01608984|Procedure|Off-pump Coronary artery bypass surgery without remote ischemic preconditioning|The applied anesthesia protocol avoids the use of propofol. Drugs: isoflurane+sufentanil anesthesia Anaesthesia is maintained by inhaled isoflurane in concentrations 0.7-0.8 % end-tidal with additional sufentanil injected during surgery, as required.
16171917|NCT01608958|Drug|Oxytocin|10 IU oxytocin in 500 ml infusion
16171918|NCT01608958|Drug|Oxytocin|10 IU oxytocin IM injection
16171919|NCT01608945|Drug|Hydrocortisone sodium succinate|100mg/day
16171920|NCT01608932|Procedure|Telemonitoring for frail patients with chronic diseases|"Patients are equipped with a telemonitoring kit that can be composed by a portable wrist clinic device, a digital weight scale and a glucometer for clinical parameters measuring, according to the pathologies of the patient. The equipment is completed by a gateway device for data transmission.
~The patient can monitor a complete set of clinical parameters, such as pulse-oxymetry, heart rate, blood pressure, ECG, body weight and glycemia with a frequency set by the clinician in the personalized treatment plan. In the same protocol the clinician includes also the alarm thresholds that determine when the clinical measures are out-of-range. Data are transmitted to a regional eHealth centre where a group of operators keeps these information under control and alerts the general practitioner in case of worsening of symptoms."
16171921|NCT01608919|Other|blood tests|thromboelastogram platelet mapping
16171922|NCT01608906|Drug|low dose intravenous heparin (LDIVH)|The LDIVH (experimental) group will receive a continuous heparin drip titrated to a prothrombin time (PTT) of 40-45. LDIVH subjects will have PTT tested within 24 hours prior to initiation of LDIVH. In addition, these subjects would continue to have a PTT tested every 6 hours until the PTT value falls between 40-45. All LDIVH subjects will have PTT values measured at least daily. This will continue until ICU discharge or a maximum of 28 days.
16171923|NCT01608906|Drug|Heparin|5000 units given subcutaneously three times a day until ICU discharge or a maximum of 28 days
16171924|NCT01608893|Drug|Carvedilol|6.25 po bid titrated to 25 mg bid as tolerated over a 1 month period
16171925|NCT01608893|Drug|Metoprolol|titrated to 50 mg po bid as tolerated over a 1 month period
16171926|NCT01608880|Drug|nitroglycerin ointment|Nitroglycerin ointment will be applied to mastectomy skin flaps at the end of surgery. A maximum of 7.5cm strip of 2% Nitroglycerin ointment will be applied (equivalent to a maximal dose of 45mg)
16171927|NCT01608880|Drug|Polysporin ointment|Polysporin ointment will be applied as the control ointment on the mastectomy flap skin at the end of surgery. A maximum of 7.5cm strip of ointment will be applied to the skin.
16171928|NCT01608867|Biological|OMP-54F28|dose escalation of 0.5, 1, 2.5, 5, and 10 mg/kg administered IV once every 3 weeks
16171929|NCT01608854|Other|Antibiotic Protocol|Patients were given postoperative antibiotics according to their randomization; antibiotic type and dosage were determined by the attending physician.
16171930|NCT01608841|Drug|Erlotinib|Erlotinib 100 mg 1# PO qd till disease progression
16171931|NCT01608815|Biological|Typhoid Vi polysaccharide|0.5 mL, Intramuscular
16171932|NCT01608802|Other|Palliative care|Regular appointments with an existing clinic nurse who has been trained in palliative care, the patient is asked about their physical, psychological, social and spiritual problems, and a care management plan devised with referral as necessary.
16171933|NCT01608802|Other|Standard care|Patients attend monthly for their ART monitoring and prescription filling, and a multiprofessional team is available as necessary.
16171934|NCT01608789|Device|Virtue® Male Sling|The Coloplast Virtue® Male Sling is a Class II, implantable, sub-urethral, permanent, non-absorbable support sling indicated for the surgical treatment of male stress urinary incontinence (SUI) resulting from intrinsic sphincter deficiency (ISD).
16171935|NCT01608776|Device|MIST Therapy|The MIST Therapy System is used as a non-contact method of delivering ultrasound to treat chronic wounds.
16171936|NCT01608776|Other|SOC - Standard of Care|Standard of Care includes wound cleansing and debridement as needed, moist wound healing dressings, and offloading
16171937|NCT01608763|Behavioral|Check Your Drinking (CYD) personalized feedback intervention|The CYD provides problem drinkers with a personalized summary of their drinking that compares his or her drinking with that of the general population. The CYD also provides an assessment of the severity of the person's drinking problem.
16171938|NCT01608750|Drug|Pantoprazol|40mg/day, oral, 28 days
16171939|NCT01608750|Drug|Folic Acid|5 mg/day, oral, 28 days
16171940|NCT01608737|Drug|PegIFN/RBV|PegIFN/RBV for 48 weeks
16171941|NCT01608737|Drug|BI 201335|BI 201335 once daily high dose for 12 weeks
16171942|NCT01608737|Drug|BI 201335|BI 201335 once daily high dose for 12 weeks
16171948|NCT01608698|Drug|30 mcg ethinylestradiol/2 mg chlormadinone acetate|By orally 1 tablet before bedtime for 21 days and withdrawal 7 days after that start the new cycle. Total study period is 6 cycles of pills.
16171949|NCT01608698|Drug|30 mcg ethinylestradiol/3 mg drospirenone|By orally 1 tablet before bedtime for 21 days then withdrawal 7 days after that start the new cycle. Total study period is 6 cycles of pills.
16171950|NCT01608672|Biological|botulinum toxin Type A|botulinum toxin Type A (BOTOX®) treatment to glabellar lines as prescribed by the Investigator over at least 5 years.
16171951|NCT01608659|Drug|botulinum toxin Type A|Previous treatment with botulinum toxin Type A for treatment of facial lines
16171952|NCT01608646|Drug|S-1 plus oxaliplatin|S-1 40 mg/m2 administered orally BID after breakfast and evening meal from Day 1 through Day 14 with a single dose of oxaliplatin 130 mg/m2 will be administered as an 2-hour IV infusion following the morning dose of S-1 on Day 1. The combination therapy will be repeated every 3 weeks.
16171953|NCT01608633|Other|Spray and stretch|Physiotherapeutic technique which consist in stretching the muscle while a cold spray is applied on the skin.
16171954|NCT01608607|Other|Fructose-containing sugar sweetened beverages|Oral dietary fructose-containing sugar sweetened beverages in isocaloric exchange for other sources of carbohydrate (isocaloric trials) or hypercaloric exchange for beverages containing a non-nutritive sweetener or added to a control diet as a source of excess energy (hypercaloric trials)
16171955|NCT01608594|Drug|administration of ipilimumab10mg/kg|"Ipilimumab IV infusion:
~Day 0 (within 1-2 weeks of baseline biopsy) every 3 weeks for 2 doses followed by definitive surgery
~After surgery recover-y resume at the same dose for 2 additional doses given 3 weeks apart
~Dose continued 12 weeks later for 4 additional doses given 12 weeks apart
~Interferon Alfa-2b will be given concurrently with ipilimumab. Each patient will receive Interferon Alfa-2b at 20 MU/m²/day intravenously for 5 consecutive days out of 7 every week for 4 weeks, followed by 10 MU/m²/d subcutaneously every other day, 3 times each week for 2 weeks, followed by definitive surgery. After surgery recovery, Interferon Alfa-2b will be resumed at 10 MU/m²/d subcutaneously, every other day three times a week for 46 additional weeks."
16171956|NCT01608594|Drug|administration of ipilimumab 3mg/kg + HDI|"Ipilimumab IV infusion:
~Day 0 (within 1-2 weeks of baseline biopsy) every 3 weeks for 2 doses followed by definitive surgery
~After surgery recover-y resume at the same dose for 2 additional doses given 3 weeks apart
~Dose continued 12 weeks later for 4 additional doses given 12 weeks apart
~Interferon Alfa-2b will be given concurrently with ipilimumab. Each patient will receive Interferon Alfa-2b at 20 MU/m²/day intravenously for 5 consecutive days out of 7 every week for 4 weeks, followed by 10 MU/m²/d subcutaneously every other day, 3 times each week for 2 weeks, followed by definitive surgery. After surgery recovery, Interferon Alfa-2b will be resumed at 10 MU/m²/d subcutaneously, every other day three times a week for 46 additional weeks."
16171957|NCT01608581|Other|multimedia burn awareness campaign|Television commercials x4 delivered 86 times over 10 days plus logo in print media daily in two papers in two cities
16171958|NCT01608568|Device|Device is the type of suture used: Quill suture vs. Interrupted suture|To compare two methods of polypropylene mesh attachment during robotic assisted laparoscopic sacrocolpopexy (RALSC): running technique using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).
16171959|NCT01608555|Drug|tobramycin|inhaled tobramycin 300 mg single dose OD for 28 days
16171960|NCT01608542|Drug|Fostamatinib 100mg|oral tablet
16171961|NCT01608542|Drug|Fostamatinib 200mg|oral tablet
16171962|NCT01608529|Device|Feel Breathe, restriction device ventilatory nasal|The Feel Breathe (FB) consisted of a small adhesive strip that is placed across the bridge of the nose during exercise. The FB was place following procedures for placement as indicated by the manufacturer's directions, while the placebo nasal, was placed over the nostrils of the subject, without interfering nasal breathing; thus, nasal airflow resistance was not increase. Each subject was required to perform three identical submaximal exercises with intensity at 50% VT1-VT2 under different breathing conditions. The breathing conditions were: oronasal, nasal and FB breathing. All participants performed three trials of stable load (50% VT1-VT2) for 10 minutes in the three conditions mentioned above, setting the cadence at 70-75 rpm, and controlling the same in all three exercise conditions.
16171963|NCT01608516|Radiation|68Ga-NODAGA-RGD PET/CT|200 MBq 68 Ga-NODAGA-RGD will be administered i.v. and images centred on the carotid area acquired
16171964|NCT01608503|Procedure|lung deflation|lung was deflated during respiration cycle
16171965|NCT01608503|Procedure|lung inflation|lung was inflated during respiratory cycle
16171966|NCT01608490|Device|RePneu Lung Volume Reduction Coil System|The LVRC group will undergo two bronchoscopic sessions under general or moderate sedation. During the procedure, subjects will be treated with Coils according to the Instructions for Use.
16171967|NCT01608464|Drug|irinotecan and docetaxel|combination of irinotecan and docetaxel regimen for 2 cycles, recycling every 21 days Irinotecan 100 mg/m2 by intra venous infusion over 2 hours in day1 and docetaxel 40 mg/m2 over one hour will be given on day 1 Assessment by PET scan and CT chest and abdomen will be done 2-3 weeks after end of 2nd cycle of irinotecan and docetaxel
16171968|NCT01608464|Drug|Cisplatin, fluorouracil and concurrent radiation therapy|Cisplatin, fluorouracil and concurrent radiation therapy 50 Gy in 25 fractions over 5 weeks with cisplatin 75 mg/m2 on first day of week 1 and week 5 and fluorouracil 750 mg/m2 daily by continuous intra venous infusion at Day 1 and Day 29 of Radiation therapy for 4 days.
16171969|NCT01608451|Drug|Cholecalciferol|Inj Arachitol 300,000 I.U/ml IM before each cycle of NACT (for total 4 cycles) and one injection before surgery.
16171970|NCT01608451|Drug|Inj. Progesterone|Injection Progesterone 500 mg deep IM before each cycle of NACT (for total 4 cycles) and one injection before surgery.
16171971|NCT01608438|Device|Customizing the Body-Machine Interface|The intervention compares two ways of customizing the body-machine interface which will be used for subjects for 40 sessions (spread over 8 months). In one case (SCI static), the body-machine interface is static. In the other case (SCI Machine Learning), there is a machine learning algorithm that adapts to the movements made by the subject.
16171972|NCT01608425|Procedure|telemedicine consultations|Replacing 2 out of 3 patient visits to out-patient clinic at hospital with treatment at home from visiting nurse and telemedicine consultations with the specialist doctor.
16171973|NCT01608412|Drug|Tacrolimus|TACROLIMUS (C0 = 5-10 ng/mL) + MPS 1440 mg + Pred
16171974|NCT01608412|Drug|Everolimus|Everolimus (C0 = 6-10 ng/mL) + MPS 1440 mg + Pred
16171975|NCT01608399|Behavioral|Metacognitive therapy|Metacognitive therapy, 10 weekly sessions of 45-60 minutes duration each
16171976|NCT01608386|Procedure|IVC clamping|in right hepatectomy,use anterior approach and infrahepatic Inferior Vena Cava clamping.
16171977|NCT01608373|Drug|Intravenous lidocaine injection|Patients in Group I (intravenous lidocaine injection group) received an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr
16171978|NCT01608373|Drug|Intraperitoneal lidocaine irrigation group|Patients in Group P(intraperitoneal lidocaine irrigation group) receive a peritoneal lidocaine irrigation with 3.5mg/kg lidocaine and normal saline 100cc. 50cc of irrigation fluid will be spread below diaphragm and 50cc of irrigation fluid will be spread around the gall bladder.
16171979|NCT01608373|Drug|Intravenous normal saline injection|The patients in Group C (placebo control group) received normal saline intravenous injection
16171980|NCT01608360|Drug|Intravenous lidocaine injection|Patients in Group I (intravenous lidocaine injection group) received an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.
16171981|NCT01608360|Drug|Intravenous normal saline injection|The patients in Group C (placebo control group) received normal saline intravenous injection
16171982|NCT01608347|Drug|LMWH+Folic acid|Patients will receive a fixed dose of 40 mg of enoxaparin subcutaneous daily. Treatment will start once positive pregnancy test and will be continued until abortion or delivery (if premature), or 37 weeks of pregnancy. Additionally, 500 micrograms Folic acid tablet once daily will be started once positive pregnancy test and continues until 13 weeks' of gestation.
16171983|NCT01608347|Drug|Folic Acid|Folic acid 500 micrograms daily once positive pregnancy test until the 13th week of pregnancy or abortion
16171984|NCT01608334|Drug|Fentanyl|1mg 0.5% bupivacaine + fentanyl 20 mcg + 1.8 ml glucose ( total 2.4-ml) VS 1mg 0.5% bupivacaine + sufentanil 5 mcg + 2.1ml glucose (total 2.4-ml) intrathecally.
16171985|NCT01608334|Drug|Sufentanil|1mg 0.5% bupivacaine + fentanyl 20 mcg + 1.8 ml glucose ( total 2.4-ml) VS 1mg 0.5% bupivacaine + sufentanil 5 mcg + 2.1ml glucose (total 2.4-ml) intrathecally.
16171986|NCT01608321|Device|rTMS|Repetitive Transcranial Magnetic Stimulation
16171987|NCT01608321|Device|Sham device|Placebo Device that simulates active rTMS treatment
16171988|NCT01608308|Drug|IV Acetaminophen|1000mg IV acetaminophen over 15 minutes every 4 hours for up to 2 doses.
16171989|NCT01608308|Drug|Placebo|100 mL of 0.9% normal saline over 15 minutes in place of IV acetaminophen.
16171990|NCT01608295|Drug|Vilazodone; Viibryd|Subjects randomized to receive vilazodone blindly will have incremental dose titration of 10mg per day for the 1st week; 20mg per day the 2nd week; 40mg per day for the 3rd-12th week. Doses of the drugs will be adjusted according to individual tolerability and safety.
16171991|NCT01608295|Drug|Paroxetine; Paxil|Subjects randomized to receive paroxetine blindly will have incremental dose titration of paroxetine 10mg per day for the 1st week; 20mg per day for the 2nd week; and 30mg per day for the 3rd-12 week. Doses of the drugs will be adjusted according to individual tolerability and safety.
16171992|NCT01608282|Behavioral|OPEN website|The OPEN website includes interactive modules that allow users to prioritise their daily activities, set goals and find venues where they can participate in different types of activities according to their preferences and the local availability
16171993|NCT01608269|Drug|Abacavir/Lamivudine|one tablet once a day
16171994|NCT01608243|Biological|SLIT tablets of house dust mite allergen extracts|10 dosing days
16171995|NCT01608243|Biological|Matching placebo|10 dosing days
16171996|NCT01608217|Drug|delta-9-tetrahydrocannabinol (delta-THC)|delta-THC 1.5 mg (tablet)three times daily for a period of 3 weeks.
16171997|NCT01608217|Drug|Placebo|placebo (tablet) three times daily for a period of three weeks.
16171998|NCT01608217|Drug|Acetaminophen|Acetaminophen 1000 mg three times daily for a period of 3 weeks
16171999|NCT01608217|Drug|Acetaminophen|Acetaminophen 1000 mg three times daily for a period of three weeks
16172000|NCT01608191|Behavioral|CBT follow up|11 weeks programme conducted via internet. CBT with focus on weight stability.
16172001|NCT01608165|Procedure|Surgical treatment for renal mass|Patients will be randomised to receive a partial nephrectomy as treatment for their renal cancer mass
16172002|NCT01608165|Procedure|Percutaneous Radiofrequency ablation|Patients may be randomised to undergo a radiofrequency ablation treatment for their renal cancer mass
16172003|NCT01608165|Procedure|Laparascopic or percutaneous cryoablation|Patients may be randomised to undergo cryoablation as treatment for their renal cancer mass
16172007|NCT01608139|Drug|Curcumin|Starting dose: 4 grams by mouth per day. During the first cycle only, Curcumin given on Day 1. Beginning with Cycle 1 Day 5, all agents will be administered continuously.
16172008|NCT01608139|Drug|Sorafenib|Starting dose: 200 mg by mouth daily. During the first cycle only, Sorafenib given on Day 5. Beginning with Cycle 1 Day 5, all agents will be administered continuously.
16172009|NCT01608139|Drug|Vorinostat|Starting dose: 100 mg by mouth daily. During the first cycle only, Vorinostat given on Day 3. Beginning with Cycle 1 Day 5, all agents will be administered continuously.
16172010|NCT01608126|Procedure|cervical block|"In brief, the superficial block was performed using a 22G needle (07 x 40 mm). The mixture injected was 15 ml of 0.5% bupivacaine + 10 ml of 1% lidocaine. Deep cervical plexus block was performed using a Stimuplex DR stimulating needle and the dose of anaesthetic used was 10 ml 0.5% bupivacaine + 5 ml 1% lidocaine applied in the vicinity of the C3 nerve root.
~The MCPB performed using ultrasound-guidance aiming specifically for the interfascia space. Eighteen ml of 0.375% bupivacaine was injected into the interfascia space at the level of C3 vertebral body using a 22G needle (07 x 40 mm)."
16172011|NCT01608100|Device|ARCHITECT STAT High Sensitive Troponin I Assay|"Test blood samples from the ARCHITECT STAT High Sensitive Troponin I Assay. Results obtained will be used to assess the prognosis of subjects for risk of ACM/MACE in the timeframes (30 days and 90 days) after the Emergency Department visit.
~Troponin results will be compared to documented ACM/MACE events at the 30 day and 90 day time points after Emergency Department visit."
16172015|NCT01608074|Procedure|Radical fimbriectomy|"Laparoscopic bilateral radical fimbriectomy :
~Complete resection of the tubes, from the uterine tube (up against the uterus) to the fimbriae, with resection of the part of the ovary adjacent to the ovarian fimbriae (adhering to the ovary)"
16172016|NCT01608074|Other|Histopathology SEE-FIM|Anatomopathological study of surgical specimens
16172017|NCT01608061|Device|DBS-f on|deep brain stimulation of the fornix
16172018|NCT01608061|Device|DBS-f off|deep brain stimulation of the fornix turned off
16172019|NCT01608048|Device|transcutaneous electrical acupoint stimulation (TEAS);EA|TEAS group (conventional IVF + TEAS), electro-acupuncture (EA) group (conventional IVF + electro-Acu.), and control group (only conventional IVF) Parameter of TEAS or EA: frequency of 2/100 Hz；moderate electrical current. Treatments start from the day 3 of menstruation，once every two days, 30 min for each for two continuous weeks.
16172020|NCT01608035|Procedure|Sciatic catheter|presurgical sciatic catheter insertion
16172021|NCT01608035|Procedure|Stump catheter|intraoperative placed stump catheter
16172022|NCT01608022|Drug|PF804|45 mg p.o. daily and continuously (28-day treatment as one treatment cycle)
16172023|NCT01608009|Drug|Pazopanib and paclitaxel|Pazopanib 800mg od for 7 days, followed by 18 weeks of combination therapy (paclitaxel 80mg/m2 weekly and pazopanib 800mg od). Following the completion of combination therapy, patients will continue on maintenance pazopanib 800mg od until disease progression.
16172024|NCT01607996|Procedure|Epidural anesthesia|Epidural will be performed using carbostesin (0.1%), fentanyl (2 microg/ml) administered continuously at a rate of 6 to 15 ml/hour
16172025|NCT01607996|Drug|Patient controlled intravenous analgesia|Fentanyl 10 microg/ml at continuous flow of 10 to 20 microg/hour
16172026|NCT01607983|Drug|inhaled nitric oxide|20 parts per million (ppm) of inhaled nitric oxide
16172027|NCT01607970|Drug|Oxytocin|Oxytocin: 24 IU; 3 puffs per nostril, each with 4 IU OXT
16172028|NCT01607957|Drug|TAS-102|35 mg/m2/dose, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met.
16172029|NCT01607957|Drug|Placebo|Placebo tablets, orally, twice daily on days 1-5 and 8-12 of each 28-day cycle. Number of cycles: until at least one of the discontinuation criteria are met.
16172030|NCT01607931|Behavioral|Exercise|1 hour of cycling at 50% of maximum power output
16172031|NCT01607918|Drug|D1-D5: (lansoprazole + amoxicillin ) D6-D10: (lansoprazole+clarithromycin +metronidazole)|D1-D5: (lansoprazole 30mg + amoxicillin 1gm) bid D6-D10: (lansoprazole 30mg+clarithromycin 500mg+metronidazole 500mg) bid
16172032|NCT01607918|Drug|D1-D14: (lansoprazole + clarithromycin + amoxicillin)|D1-D14: (lansoprazole 30mg + clarithromycin 500mg + amoxicillin 1gm) bid
16172033|NCT01607905|Drug|Selinexor|Participants in this study will receive selinexor orally at dose levels specified for their respective dose cohorts. Dosing will begin at 3 mg/m^2 twice a week and will escalate until the MTD or RP2D is determined. Cycles will be repeated in 4-week (28 days for schedule 1 to 7) and 3-week (21 days for schedule 8) intervals until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, dose adjustment will be permitted.
16172034|NCT01607905|Drug|Acetaminophen|Oral 500 mg (in Cycle 1, Week 1) to 1000 mg (in Cycle 1, Week 2 and onwards) of acetaminophen will be administered 1 hour prior to each selinexor dose up to 8 doses per cycle (28 days per cycle)
16172035|NCT01607892|Drug|KPT-330|
16172036|NCT01607879|Drug|Standard of care ADT + (HMB + arginine + glutamine)|"1 packet of HMB+arginine+glutamine contains 1.5 g of the amino acid metabolite HMB + 7 g arginine and 7 g glutamine.
~Take one packet twice daily for 3 months"
16172037|NCT01607879|Other|Standard of care ADT|Patient will receive standard of care androgen deprivation therapy (ADT) alone
16172038|NCT01607866|Procedure|Quadrant parotidectomy|Excision of one quadrant of the parotid gland which is comparable to half of the superficial lobe of the gland
16172039|NCT01607866|Procedure|Superficial parotidectomy|Excision of the whole superficial lobe of the parotid gland
16172040|NCT01607853|Drug|Daivobet® gel applied then removed after 10 minutes (+/- 2 minutes)|Once daily application, 3 weeks
16172041|NCT01607853|Drug|Daivobet® gel applied then removed after 20 minutes (+/- 2 minutes)|Once daily application, 3 weeks
16172042|NCT01607853|Drug|Daivobet® gel applied for 24 hours (+/- 2 hours)|Once daily application, 3 weeks
16172043|NCT01607853|Drug|Daivobet® gel vehicle applied for 24 hours (+/- 2 hours)|Once daily application, 3 weeks
16172044|NCT01607840|Procedure|transcranial direct current stimulation|delivery of transcranial direct current stimulation or sham for 20 to 60 minutes
16172045|NCT01607827|Procedure|Polyp removal upon insertion and withdrawal|"Endoscopic procedures:
~All polypectomies in the study groups were performed using the same techniques as in the standard care of non-study patients, using snare loops, hot biopsy forceps, with and without submucosal injection of saline/epinephrine. Polyps larger than 3 mm were removed by snare, polyps smaller than 4 mm were removed by cold biopsy. There were no differences upon insertion or withdrawal.
~The endoscopist removed all visible polyps instantly regardless whether advancing the instrument to the cecum or pulling back."
16172046|NCT01607827|Procedure|Polyp removal upon withdrawal only|"Endoscopic procedures:
~All polypectomies in the study groups were performed using the same techniques as in the standard care of non-study patients, using snare loops, hot biopsy forceps, with and without submucosal injection of saline/epinephrine. Polyps larger than 3 mm were removed by snare, polyps smaller than 4 mm were removed by cold biopsy. There were no differences upon insertion or withdrawal.
~The endoscopist advanced the endoscope to the cecum without removing polyps. Upon withdrawal, all visible polyps were removed successively by standard techniques."
16172047|NCT01607775|Device|Implantation of a PEEK-cage|A commercially avaliable cuboid cervical cage will be implantet
16172048|NCT01607775|Device|PMMA-cage|The in-house produced cervical cage will be implanted
16172049|NCT01607762|Drug|Aripiprazole|Type= exact number, unit= mg, number= 5, form= tablet, route= oral administration. A single oral dose of a 5-mg aripiprazole tablet will be administered after an overnight fast.
16172050|NCT01607762|Drug|Quetiapine|Type= exact number, unit= mg, number= 100, form= tablet, route= oral administration. A single oral dose of two 50-mg quetiapine tablets will be administered after an overnight fast.
16172051|NCT01607762|Drug|Olanzapine|Type= exact number, unit= mg, number= 5, form= tablet, route= oral administration. A single oral dose of a 5-mg olanzapine tablet will be administered after an overnight fast.
16172052|NCT01607762|Drug|Risperidone|Type= exact number, unit= mg, number= 1, form= tablet, route= oral administration. A single oral dose of a 1-mg risperidone tablet will be administered after an overnight fast.
16172053|NCT01607762|Drug|Paliperidone|Type= exact number, unit= mg, number= 3, form= tablet, route= oral administration. A single oral dose of a 3-mg paliperidone tablet will be administered after an overnight fast.
16172054|NCT01607749|Behavioral|Educational Program|"Schools in the intervention group received the educational program Asthma, Sport and Health, as validated by our group. This program will be taught to students in three lessons with equipment designed and developed by the research group to be taught within the curriculum of physical education subject.
~Teachers of physical education specialists responsible for the project at each center will receive the training curriculum for use in a training seminar for a school day by researchers from the health of our group. Once familiar with the educational package of three sessions taught his students and fellow faculty (on different days for teachers and students) within 15-30 days."
16172055|NCT01607749|Other|Usual Asthma Information for teachers|Common asthma information for teachers
16172056|NCT01607736|Behavioral|Virtual Gait Training|The intervention consisted of 12-minute virtual gait training sessions once daily for a total of 14 weekdays within a three-week period. The intervention video showed walking legs of a 30-year-old woman for female and a 46-year-old man for male participants. The video screen was adjusted in height such that it corresponded to the legs of the standing participant, with a mirror placed above it. Participants began the training session with a circa one minute of concentration on the upcoming intervention. Afterwards, the video was started. Participants were instructed to stand (when necessary, to sit) and observe the video and mirror, and to imagine themselves walking. Training sessions were supervised by a physical therapist who gave additional instructions and comments regarding participants' visual/kinesthetic imagination of themselves performing the observed movement. Verbal and physical reactions during training sessions were documented in written form and sometimes videotaped.
16172057|NCT01607723|Other|NAVA ventilatory mode|The two ventilatory modes will be studied during 24h in intubated patients in random order.
16172058|NCT01607723|Other|PAV+ ventilatory mode|The two ventilatory modes will be studied during 24h in intubated patients in random order.
16172059|NCT01607697|Behavioral|Mindfulness Training|Mindfulness Training
16172060|NCT01607684|Device|Magnetic Marker Imaging (MMI) with Magma 3D system|Magnetic Marker Imaging (MMI). It comprises of a high-resolution three-dimensional detector system, that detects passively and continuously the magnetic field of a magnetic marker capsule (1g, 6x12mm), which is taken orally by the subject. Changes in frequency, intensity and duration of oscillating marker movements allow us to delineate migrating gastric motor complexes. The Magnetic Marker Imaging takes up to 4 h in which the patient lies in a bed. Short interruptions (e.g. to visit the restroom) during this 4 h period are possible.
16172061|NCT01607671|Drug|Timolol maleate|Timolol 0.5% 1 drop twice daily to the effected eye for 4 weeks.
16172062|NCT01607658|Drug|Placebo|placebo intranasal gel administered prn, 2-8 hours before a planned sexual event
16172063|NCT01607658|Drug|Low dose TBS-2|Low dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event
16172064|NCT01607658|Drug|Medium dose TBS-2|Medium dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event
16172065|NCT01607658|Drug|High dose TBS-2|High dose testosterone intranasal gel administered prn 2-8 hrs before a planned sexual event
16172066|NCT01607645|Drug|decitabine|Given IV
16172067|NCT01607645|Drug|idarubicin|Given IV
16172068|NCT01607645|Drug|cytarabine|Given IV
16172069|NCT01607632|Behavioral|loving-kindness meditation|A 12-week duration, 90 minute per session loving-kindness meditation course
16172070|NCT01607619|Dietary Supplement|Anatabine|1mg anatabine in a mint-flavored mannitol lozenge
16172071|NCT01607593|Drug|sertraline (Zoloft)|Dosage form: Tablet, Dosage: over 25 mg/day, duration: Not defined
16172072|NCT01607580|Drug|low-dose glucocorticoid Methylprednisolone|patients receive low-dose glucocorticoid from day 5 post transplant
16172073|NCT01607554|Drug|Irinotecan|"180 mg/m2 Irinotecan intravenously over 60 minutes on day 1 of each cycle
~Pre-medication for irinotecan: palonosetron 0.25 mg and dexamethasone 8 - 16 mg, both administered intravenously. Atropine 0.25 - 0.5 mg subcutaneously or IV is at the discretion of the treating physician"
16172074|NCT01607541|Behavioral|BCAP peer-driven intervention (PDI)|"The Brooklyn Community Action Project (BCAP) PDI entails structured sessions including the computerized CARE for Prevention tool, 3 peer education experiences, and 6 months of navigation for those HIV infected (if HIV-negative: total 3.5 hours of facilitated/computer intervention activities, plus peer education experiences; if HIV-positive: 5 hrs facilitated/computer activities, plus peer education experiences and navigation)."
16172075|NCT01607541|Behavioral|Control intervention|The control arm will receive a time- and attention-matched HIV counseling and testing intervention and for those found HIV-infected, an appointment with HIV services and reminders, the current standard of care.
16172076|NCT01607528|Dietary Supplement|Winclove-849|6 g of Winclove-849 containing Bifidobacterium bifidum W23, Bifidobacterium lactis W52, Lactobacillus acidophilus W37, Lactobacillus brevis W63, Lactobacillus casei W56, Lactobacillus salivarius W24, Lactococcus lactis W19, Lactococcus lactis W58 at a concentration of 2.5 x 109 cfu/g
16172077|NCT01607528|Dietary Supplement|Placebo|A similar looking and tasting powder with no active substances
16172078|NCT01607515|Other|Impedance cardiography|noninvasive measure of cardiac index by impedance cardiography.
16172079|NCT01607489|Radiation|Dual-energy computed tomography investigation|"1x 20ml Ultravist (370mg J/ml)3-5ml/s,
~1x 70ml Ultravist (370mg J/ml)3-5ml/s Contrast agent administration"
16172080|NCT01607476|Drug|C11 PiB|One time intravenous administration of 8-22 millicurie (mCi) C11 PiB
16172081|NCT01607476|Drug|F18 Flutametamol|One time intravenous administration of 3-7 mCi F18 Flutametamol.
16172082|NCT01607463|Procedure|Transcutaneous electrical nerve stimulation (Empi, USA)|In the active TENS group, TENS at 80 pulsed currents per second (PPS) with a pulse duration of 200 μs were delivered for 20 minutes. Current amplitude was slowly increased until a level was reached that participants reported was the maximum level they could tolerate below pain threshold without noticeable muscle contraction and maintained this intensity.
16172083|NCT01607463|Procedure|Transcutaneous electrical nerve stimulation (Empi, USA)|"In the placebo group the TENS device had no current output although the power on indicator light remained active."
16172084|NCT01607450|Drug|GLP-1 Low Dose|0.5mmol/kg/hr GLP-1 for 12 hours prior to PET study
16172085|NCT01607450|Drug|GLP-1 Mid-Range Dose|1.5mmol/kg/min for 12 hours prior to PET study
16172086|NCT01607450|Drug|GLP-1 High Dose|4.0mmol/kg/min GLP-1 for 12 hours prior to PET study
16172087|NCT01607450|Drug|Saline|Normal saline placebo infusion for 12 hours prior to PET study
16172088|NCT01607424|Behavioral|cognitive remediation|RECOS: cognitive remediation for schizophrenia CRT: cognitive remediation therapy
16172089|NCT01607411|Drug|Fluoride|Fluoride Toothpaste
16172090|NCT01607411|Drug|Placebo|Fluoride free toothpaste
16172091|NCT01607398|Drug|ADOAIR250|250 mcg inhalation, twice daily, from week0 -12.
16172092|NCT01607398|Drug|Placebo|Placebo inhalation, twice daily, from week0 -12.
16172093|NCT01607385|Drug|GSK2330672|BID, repeat doses
16172094|NCT01607385|Drug|Placebo|BID, repeat doses
16172095|NCT01607385|Drug|GSK1614235|BID, co-dosed BID with last dosing day of active/placebo repeat doses
16172096|NCT01607372|Drug|GSK2245035|GSK2245035 nasal spray solution. A solution formulation in saline, preserved with Benzalkonium Chloride and Disodium Edetate
16172097|NCT01607372|Device|Type 1 amber glass bottle|fitted with a metered Valios VP7 pump
16172098|NCT01607372|Other|Placebo|As for GSK2245035 nasal spray solution except for omission of the active ingredient
16172099|NCT01607346|Drug|ezogabine/retigabine|Starting dose of 300mg/day, titrate up to a targeted maximum dose of 1200 mg/day. Dose can be reduced to a minimum of 600 mg/day if unable to tolerate higher doses
16172100|NCT01607333|Drug|Lamotrigine use|Lamotrigine prescription during the study period
16172101|NCT01607320|Drug|Raloxifene|Thirty PCOS patients treated with 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 following an initial provera withdrawal
16172102|NCT01607320|Drug|Clomiphene|Thirty PCOS patients treated with 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 following an initial provera withdrawal
16172103|NCT01607307|Drug|Oral/enteral TJ-100 solution|Oral TJ-100 solution (5 g tid, 15 g/day) given immediately before meals or every 8 h from preoperative day 3 to postoperative day 7 for 10 consecutive days. A diluent TJ-100 solution given immediately after surgery and on postoperative day 1 via Argyle enteral feeding tube (10 Fr), which terminates in the jejunum to prevent aspiration pneumonia.
16172104|NCT01607307|Drug|Oral/enteral placebo solution|Oral placebo solution (5 g tid, 15 g/day) given immediately before meals or every 8 h from preoperative day 3 to postoperative day 7 for 10 consecutive days. A diluent placebo solution given immediately after surgery and on postoperative day 1 via Argyle enteral feeding tube (10 Fr), which terminates in the jejunum to prevent aspiration pneumonia.
16172105|NCT01607294|Drug|ETC-1002|ETC-1002 Daily for 4 weeks
16172106|NCT01607294|Drug|Placebo|Placebo Daily for 4 weeks
16172107|NCT01607268|Procedure|Magnetic Resonance Spectroscopy Imaging|Proton magnetic resonance spectroscopy [1H-MRS] is an emerging imaging tool that allows for non-invasive assessment of brain neurochemistry in human subjects. This technique allows for in vivo quantification of the concentration of neurotransmitters and metabolites in discrete brain regions through detection of hydrogen nuclei in these molecules. Autonomic failure patients will undergo a single imaging session lasting 30 to 90 minutes (0.5-1.5 hours) in the Vanderbilt Human Imaging Institute.
16172108|NCT01607255|Drug|Indigo carmine|0.008% indigo carmine in water is used as a surface contrast agent to enhance visualization of diminutive polyps (adenoma) during screening colonoscopy
16172109|NCT01607255|Procedure|water (exchange) method|Residual pocket of air will be suctioned. Water is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions.
16172110|NCT01607255|Procedure|water (exchange) plus dye method|Residual pocket of air will be suctioned. Water with 0.008% indigocarmine is infused using a peristaltic pump to facilitate scope advancement until the cecum is reached. Dirty water will be suctioned and clean water is infused. Air will not be insufflated until the cecum is reached. Residual water is suctioned and air insufflated on scope withdrawal to facilitate biopsy and removal of lesions
16172111|NCT01607255|Procedure|air method|The colonoscope is inserted gently and advanced slowly using minimal air insufflation, if necessary, the assistant will provide abdominal compression or the patient's position will be changed to facilitate scope passage. The scope is inserted until the cecum is reached. Air is insufflated on scope withdrawal for visualization and water irrigation is used to remove any adherent feces covering the mucosa. Biopsy or polypectomy is performed where indicated.
16172112|NCT01607242|Other|Endoscopy of larynx|Endoscopic Laryngeal mobility assessment
16172113|NCT01607242|Other|Voice Handicap Index|Subjective Evaluation of Voice disorders
16172114|NCT01607242|Other|Swallowing Assesment|Swallowing function questionnaire
16172115|NCT01607229|Other|observation|no intervention used, observed measurements from 3 test devices compared to reference criterion measurement for total body water and body composition
16172116|NCT01607203|Drug|Decapeptyl Daily|Decapeptyl 0.2 mg SC once 1day
16172117|NCT01607203|Drug|pregnyl|5000 IU SC
16172118|NCT01607177|Behavioral|Daily text message reminders|Daily text message reminders to motivate patients to exercise in conjunction with an exercise information sheet.
16172119|NCT01607164|Behavioral|Healthy Mood Project Website|Self-help automated online mood management course based on cognitive-behavioral methods to control depressed mood.
16172120|NCT01607151|Other|Normothermia|72 hours of targeted temperature management to achieve normothermia (36-37°C)
16172121|NCT01607151|Other|Hypothermia|72 hours of targeted temperature management to achieve hypothermia (32-34°C)
16172122|NCT01607125|Drug|Vortioxetine (Lu AA21004)|encapsulated 20 mg tablets, orally, once daily for 13 to 14 days
16172123|NCT01607125|Drug|Placebo|capsules, orally, once daily for 13 to 14 days
16172124|NCT01607112|Biological|Fluarix/Influsplit SSW 2012-2013|1 dose administered intramuscularly (or deeply subcutaneously) in the deltoid region of the non-dominant arm
16172125|NCT01607099|Procedure|Compatibility|Patients asses the compatibility of the bowel cleansing procedure
16172126|NCT01607086|Drug|Cherry lamotrigine ODT|25mg, taken orally on one study visit
16172127|NCT01607086|Drug|Cherry Placebo|Taken orally on one study visit
16172128|NCT01607073|Drug|Verapamil|"Verapamil will be prepared as a solution. A 50mg/ml oral suspension may be made with immediate release tablets and either a 1:1 mixture of Ora-Sweet and Ora-Plus or a 1:1 mixture of Ora-Sweet SF and Ora-Plus will be used.
~Children will start on a 4 weeks titration period:
~Week 1: 1mg/kg/day divided BID Week 2: 2mg/kg/day divided BID or TID Week 3: 3mg/kg/day divided BID or TID Week 4: 4mg/kg/day divided TID
~In event of adverse events, and in consultation with the family and treating physician, the dosage may be decreased to 2mg/kg/day and remain at that dose for the remainder of the study."
16172129|NCT01607060|Drug|Lactulone|Patients will receive lactulone to daily laxation
16172130|NCT01607034|Drug|Dexpramipexole|150 mg single dose
16172131|NCT01607008|Other|MRI imaging|"3 total MRI imaging studies:
~pre standard radiation treatment
~during standard radiation treatment
~post standard radiation treatment"
16172132|NCT01606995|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Patients with non-valvular atrial fibrillation who are prescribed rivaroxaban under routine treatment conditions to prevent stroke or non-central nervous system systemic embolism. Decision regarding dose and duration of treatment made at the discretion of the attending investigator
16172133|NCT01606982|Drug|MDV3100|oral
16172134|NCT01606969|Drug|scalp infiltration solution|Dex group: Dexmedetomidine 2mcg/ml-containing 1% lidocaine scalp injection by neurosurgeon(dosage: according to incision length)
16172135|NCT01606969|Drug|scalp infiltration solution|1:100000 epinephrine-containing 1% lidocaine scalp injection by neurosurgeon(dosage: according to incision length)
16172136|NCT01606956|Procedure|The cuff inflation by the resting volume|80 patients are randomly allocated into two groups : resting volume group (n=40), half the maximum volume group (n=40). In the resting volume group, the pilot balloon valve is connected to syringe without piston for keeping the valve open to the atmosphere and allowing the pressure within the cuff of LMA to equalize with atmospheric pressure. In the half the maximum volume group, the cuff of LMA is completely emptied and then the cuff is filled with the half the maximum volume.
16172137|NCT01606956|Procedure|The cuff inflation by half the maximum volume|80 patients are randomly allocated into two groups : resting volume group (n=40), half the maximum volume group (n=40). In the resting volume group, the pilot balloon valve is connected to syringe without piston for keeping the valve open to the atmosphere and allowing the pressure within the cuff of LMA to equalize with atmospheric pressure. In the half the maximum volume group, the cuff of LMA is completely emptied and then the cuff is filled with the half the maximum volume.
16172138|NCT01606930|Behavioral|Patient Primer Tool|"The instrument is completed before the scheduled appointment and is designed to prompt patients to reflect on their specific goals for the medical encounter, prioritize those goals, and to Prime them to engage in a discussion centered on their concerns and expectations. In addition, participants will be encouraged to bring this form into their physician visit and use it to engage their clinician in a discussion about their health needs."
16172139|NCT01606917|Other|Intensive lifestyle counseling|Both dietary advice and individualized advice on increased regular physical activity
16172140|NCT01606904|Behavioral|Cognitive behavioral therapy -based weight loss program|CBT-based program includes 20 group visits
16172141|NCT01606891|Behavioral|multi-component/setting parent-targeted intervention|parents assigned to this group will be asked to participate in a program of home visiting, community parenting classes, and community food and physical activity resource links
16172142|NCT01606878|Drug|Crizotinib|Given PO
16172143|NCT01606878|Drug|Cyclophosphamide|Given IV
16172144|NCT01606878|Drug|Dexrazoxane Hydrochloride|Given IV
16172145|NCT01606878|Drug|Doxorubicin Hydrochloride|Given IV
16172146|NCT01606878|Other|Laboratory Biomarker Analysis|Correlative studies
16172147|NCT01606878|Other|Pharmacological Study|Correlative studies
16172148|NCT01606878|Other|Questionnaire Administration|Ancillary studies
16172149|NCT01606878|Drug|Topotecan Hydrochloride|Given IV
16172150|NCT01606878|Drug|Vincristine Sulfate|Given IV
16172151|NCT01606852|Drug|Dexmedetomidine|loading dose (0.5 mcg/kg i.v.), followed by a continuous basal infusion (0.2-0.7 mcg/kg/hr) with 3 allowable patient-controlled self-boluses per hour (0.25 mcg/kg) each with a 20-minute lock-out. Study infusion up to 5 days.
16172152|NCT01606813|Other|Usual Care|Standard care
16172153|NCT01606813|Behavioral|Brief Physician Counseling|Primary Care Physician (PCP) will review a goal setting worksheet for weight loss with the participant and then collaboratively set a goal for weight loss.
16172154|NCT01606813|Behavioral|Referral and access to an internet weight control program|Participants will receive a login and password for the weight loss website. The website will encourage patients to set a new weight goal every 3 months and work towards a total weight loss goal of 10%. Patients will also receive an email prompt each week alerting them to new content and reminding them to check-in to the website to report their weight, intake and activity.
16172155|NCT01606813|Behavioral|Brief follow up email notes from PCPs|Patients will receive a biweekly email from their primary care physician on how they are doing with their weight loss.
16172156|NCT01606800|Drug|PEG-IFN alfa-2b|Pegylated interferon alfa-2b administered subcutaneously 1.5 mcg/kg/week
16172157|NCT01606800|Drug|ribavirin|Ribavirin 200 mg capsules administered orally daily based on weight
16172158|NCT01606787|Drug|mannitol|After induction of general anesthesia Normosol or Lactated Ringers , at a target infusion rate of 10cc/kg (+/- 1cc/kg), will be administered over the first hour of surgery. After the first hour of surgery IV fluid will be administered at 6cc/kg (+/- 1cc/kg) intended to maintain a minimum systolic blood pressure of 90-100mmHg and a minimum urine output of 0.5cc/kg/hour. The treatment arm will receive a standard dose of 12.5 grams of mannitol (200 cc of a 6.25% mannitol solution) intravenously completely infused through an existing intravenous access catheter within 30 minutes prior to renal artery clamping.
16172159|NCT01606787|Other|placebo|After induction of general anesthesia Normosol or Lactated Ringers at a target infusion rate of 10cc/kg (+/- 1cc/kg), will be administered over the first hour of surgery. After the first hour of surgery IV fluid will be administered at 6cc/kg (+/- 1cc/kg) intended to maintain a minimum systolic blood pressure of 90-100mmHg and a minimum urine output of 0.5cc/kg/hour. The placebo arm will receive 200cc of normal saline completely infused within 30 minutes prior to renal artery clamping.
16172160|NCT01606774|Other|Modernized prenatal care|Home monitoring/phone surveillance/28 week ultrasound in place of 4-5 routine prenatal visits between 18 and 36 weeks
16172483|NCT01604057|Drug|ZT-034 Mid Dose Nasal Spray|Nasal Spray
16172161|NCT01606761|Drug|Placebo|Form=solution for injection, route=subcutaneous use; every 2 weeks from Week 0 through Week 22.
16172162|NCT01606761|Drug|Placebo|Form=solution for injection, route=subcutaneous use; Weeks 2, 6, and every 4 weeks through Week 52.
16172163|NCT01606761|Drug|Sirukumab|Type=exact, unit=mg, number=50 or 100, form=solution for injection, route=subcutaneous use; every 2 weeks for 100 mg and every 4 weeks for 50 mg, Week 23 through Week 52.
16172164|NCT01606761|Drug|Sirukumab|Type=exact, unit=mg, number=100, form=solution for injection, route=subcutaneous use; Weeks 0, 2, and every 2 weeks through Week 52.
16172165|NCT01606761|Drug|Sirukumab|Type=exact, unit=mg, number=50, form=solution for injection, route=subcutaneous use; Weeks 0, 4, and every 4 weeks through Week 52.
16172166|NCT01606748|Biological|Necitumumab|"PK Run-In Period: Necitumumab administered on Day 3 of the 3-week PK run-in period as an intravenous (I.V.) infusion at an absolute dose of 800 mg
~Treatment Cycles: Necitumumab administered on Days 1 and 8 of every 3-week cycle as an intravenous (I.V.) infusion at an absolute dose of 800 mg
~Participants in Cohort 1 will receive necitumumab Process C drug product and participants in Cohort 2 will receive necitumumab Process D drug product"
16172167|NCT01606748|Drug|Gemcitabine|"PK Run-In Period: Gemcitabine administered on Day 1 of the 3-week PK run-in period as an I.V. infusion at a dose of 1250 milligram per square meter (mg/m2)
~Treatment Cycles: Gemcitabine administered on Days 1 and 8 of every 3-week cycle as an I.V. infusion at a dose of 1250 mg/m2"
16172168|NCT01606748|Drug|Cisplatin|"PK Run-In Period: Cisplatin administered on Day 1 of the 3-week PK run-in period as an I.V. infusion at a dose of 75 mg/m2
~Treatment Cycles: Cisplatin administered on Day 1 of every 3-week cycle as an I.V. infusion at a dose of 75 mg/m2"
16172169|NCT01606735|Drug|IBI-10090|dexamethasone
16172170|NCT01606722|Drug|Darunavir/ritonavir|Darunavir/ritonavir (800/100 mg once daily) monotherapy
16172171|NCT01606709|Drug|GnRH agonist|GnRH agonist 1mg one dose
16172172|NCT01606709|Drug|hCG|5,000 IU one dose
16172173|NCT01606696|Behavioral|HIIT|Higher intensity interval training.
16172174|NCT01606696|Behavioral|Standard intensity non-interval training|Standard intensity non-interval training.
16172175|NCT01606683|Other|Infant formula with GOS, beta-palmitate, acidified milk|"Infant formula supplemented with functional ingredients (galacto-oligosaccharides, beta-palmitate, acidified milk.
~Infant formula with functional ingredients is in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae."
16172176|NCT01606683|Other|Standard infant formula without functional ingredients|Standard infant formula, in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae, without functional ingredients.
16172177|NCT01606683|Other|No intervention|
16172178|NCT01606657|Procedure|Irrigation|The patient will receive irrigation as a part of their wound care
16172179|NCT01606657|Other|No Irrigation|The patient will not receive irrigation as part of their wound care
16172180|NCT01606644|Procedure|Hyperbaric oxygen|Inhalation of 100% oxygen for 90 minutes
16172181|NCT01606592|Behavioral|Panic Control Treatment (PCT)|Manualized, 13 sessions (60 min, sometimes extended to 90-120) completed in 12-16 weeks. Total duration 840-1080 min.
16172182|NCT01606592|Behavioral|Panic-Focused Psychodynamic Psychotherapy (PFPP)|Manualized, 19-24 sessions (45 min) completed in 12-16 weeks. Total duration 855-1080 min.
16172183|NCT01606592|Other|Waiting-list|Sparse telephone contact during 12 weeks, then re-randomization
16172184|NCT01606579|Drug|PRI-724|PRI-724
16172185|NCT01606579|Drug|PRI-724|PRI-724 in combination with dasatinib
16172186|NCT01606579|Drug|PRI-724|PRI-724 in combination with low dose ara-C therapy
16172187|NCT01606566|Drug|Amphinex induced PCI of bleomycin|Intravenous administration of 0.25 mg/kg Amphinex (day 0) followed by intravenous administration of bleomycin (15000 IU/m2, day 4) and laser light application (3 hours (+/- 1 hour) after bleomycin administration).
16172188|NCT01606553|Device|High-intensity IMT|High intensity short duration respiratory muscle training with a valve prototype
16172189|NCT01606553|Device|Sham High-intensity IMT|High intensity short duration respiratory muscle training using a sham valve prototype
16172190|NCT01606540|Drug|Tablets Ibumetin and placebo|"Group A: Daily tablets Ibumetin, 600 mg x 3, 7 days after reposition.
~Group B: Daily tablets Ibumetin, 600 mg x 3, 3 days after reposition. The following days placebo tablets.
~Group C: Placebo tablets 1 week after reposition."
16172191|NCT01606540|Drug|Tablets Ibumetin and placebo|"Group A: Daily tablets Ibumetin, 600 mg x 3, 7 days after surgery.
~Group B: Daily tablets Ibumetin, 600 mg x 3, 3 days after surgery. The following days placebo tablets.
~Group C: Placebo tablets for 1 week after surgery."
16172192|NCT01606527|Drug|Ibuprofen 600mg orally three times daily|Ibuprofen is taken 600mg orally three times daily
16172193|NCT01606514|Behavioral|Bounce Back Now Website|Bounce Back Now is a web-based psychoeducation and self-help website
16172194|NCT01606488|Drug|Florbetapir F 18 (18F-AV-45)|Single IV bolus injection of 370 MBq (10mCi) florbetapir will be administered approximately 50 minutes prior to a 10 minute PET scan.
16172195|NCT01606488|Other|no intervention|
16172196|NCT01606475|Biological|Allogeneic islets of Langerhans|Up to 3 intraportal infusions of cadaveric pancreatic islets of Langerhans. Each infusion to contain at least 5,000 islet equivalents/kg body weight.
16172197|NCT01606462|Drug|Oxytocin|intranasal administration, 24 IU oxytocin; ; 3 puffs per nostril, each with 4 IU OXT
16172198|NCT01606449|Procedure|Surgical Therapy|"Open Anti-reflux fundoplication according to Nissen-Rossetti, floppy Nissen, Belsey MK IV,Collis Nissen, Collis-Belsey.
~Minimally-Invasive fundoplication according to floppy Nissen, left thoracoscopic Collis-laparoscopic Nissen."
16172199|NCT01606436|Drug|Pomaglumetad methionil|Administered orally.
16172200|NCT01606436|Drug|Matching placebo|Administered orally.
16172201|NCT01606436|Drug|Moxifloxacin|Administered orally.
16172202|NCT01606423|Drug|Placebo|Administered orally, single dose
16172203|NCT01606423|Drug|LY2409021|Administered orally, single dose
16172204|NCT01606410|Other|IPC|repeated cuff inflation (220 mmhg) around an upper limb for 5 minutes, followed by 5 minutes of reperfusion (repeated 4 times)
16172205|NCT01606397|Drug|Placebo|Administered orally (capsule)
16172206|NCT01606397|Drug|LY2409021|Administered orally (capsule)
16172207|NCT01606384|Drug|VASOPRESSIN V1B RECEPTOR ANTAGONIST (SSR149415)|Pharmaceutical form: Capsule Route of administration: oral
16172208|NCT01606384|Drug|Placebo|Pharmaceutical form: Capsule Route of administration: Oral
16172209|NCT01606371|Drug|Placebo|Administered orally
16172210|NCT01606371|Drug|LY2409021|Administered orally
16172211|NCT01606358|Drug|Carboplatin and / or taxol chemotherapy|Patient with proven epithelial ovarian cancer and receiving carboplatin and / or taxol chemotherapy (usual care).
16172212|NCT01606345|Drug|Valrubicin|Eligible patients will receive percutaneous valrubicin beginning no sooner than 10 days following nephrostomy placement and within 6 weeks of tumor treatment/resection.
16172213|NCT01606332|Procedure|Interscalene block with nerve catheter|Interscalene block with ropivacaine 0.5% 10ml and placement of an indwelling nerve catheter with ropivacaine 0.2% @5ml/hr for 24 hours
16172214|NCT01606319|Drug|Acetaminophen|15 mg/kg every 6 hours as needed
16172215|NCT01606319|Drug|Ibuprofen|9.4 mg/kg every 6 hours as needed
16172216|NCT01606306|Drug|daily fluticasone propionate|Flovent® HFA, 44 mcg per inhalation, 2 inhalations twice daily
16172217|NCT01606306|Drug|Montelukast|Singulair®, 4 mg granules or chewable tablets by mouth once daily in the evening
16172218|NCT01606306|Drug|as-needed fluticasone propionate|Flovent® HFA, 44 mcg per inhalation, 2 inhalations, as needed for asthma symptoms
16172219|NCT01606293|Behavioral|Questionnaires|Completion of online surveys taking approximately 15 - 20 minutes.
16172220|NCT01606267|Other|health systems intervention: HEP+ICCM|In the HEP+ICCM intervention areas, HEWs will assess and treat childhood pneumonia with cotrimoxazole. The program will strengthen the capacity of HEWs to assess, classify and treat malaria (with ACTs), diarrhea (with ORS) and undernutrition (with therapeutic feeding) through refresher trainings and strengthening supervision, logistical support and the ICCM system overall.
16172221|NCT01606254|Drug|Paliperidone palmitate|Paliperidone palmitate aqueous suspension for injection 0.5, 1.0, 1.5 milliliter equivalent to 50, 100, 150 mg paliperidone respectively as intramuscular injection on Days 1, 8, 36 and 64.
16172222|NCT01606241|Drug|Cyclophosphamide|Given PO
16172223|NCT01606241|Other|Laboratory Biomarker Analysis|Correlative studies
16172224|NCT01606241|Biological|Multi-epitope Folate Receptor Alpha Peptide Vaccine|Given ID
16172225|NCT01606228|Drug|Paliperidone ER|Type= range, unit= mg/day, number= 3 to 12, form= tablet, route= oral use. Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
16172226|NCT01606215|Drug|Mesenchymal stem cells|1.0-2.0 million cells/kg body weight
16172227|NCT01606215|Drug|Placebo|Placebo
16172228|NCT01606202|Drug|GW-1000-02|Contained delta-9-tetrahydrocannabinol (THC) (27 mg/ml):cannabidiol (CBD) (25 mg/ml) as extract of Cannabis sativa L., with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl (THC 2.7 mg and CBD 2.5 mg). The maximum permitted dose of study medication was eight actuations in any three-hour period, and 48 actuations in any 24 hour period.
16172229|NCT01606202|Drug|Placebo|Contained peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl. The maximum permitted dose of study medication was eight actuations in any three-hour period, and 48 actuations in any 24 hour period.
16172230|NCT01606189|Drug|GW-1000-02|Contains delta-9-tetrahydrocannabinol (THC) (25 mg/ml) and cannabidiol (CBD) (25mg/ml) as extract of Cannabis sativa L, with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl (THC 2.5 mg and CBD 2.5 mg). The maximum daily exposure was set at 48 actuations per day.
16172231|NCT01606189|Drug|GW-2000-02|Contains THC (25 mg/ml) as extract of Cannabis sativa L, with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl (THC 2.5 mg). The maximum daily exposure was set at 48 actuations per day.
16172232|NCT01606189|Drug|Placebo|Contains peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl. The maximum daily exposure was set at 48 actuations per day.
16172233|NCT01606176|Drug|GW-1000-02|Each actuation of GW-1000-02 (100 μl) delivered a dose containing 2.5 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). The maximum permitted dose of study medication was eight actuations in any three hour period (20 mg THC/20 mg CBD) and 48 actuations in any 24 hour period (120 mg THC/120 mg CBD).
16172234|NCT01606176|Drug|Placebo|Each actuation of placebo (100 μl) delivered the excipients only. The maximum permitted dose of study medication was eight actuations in any three hour period and 48 actuations in any 24 hour period.
16172235|NCT01606163|Biological|GC1102|"Description: GC1102 IV bolus injection during 10~ 30 seconds.
~Amount: group1-3ml, group2-5ml, group3-8ml
~Subject number: group1-8, group2-8, group3-8
~Administration time: 1day, 2day, 3day, 4day, 5day, 6day, 7day(total: 7 times)"
16172236|NCT01606163|Other|JW normal saline|"Description: Normal saline IV bolus injection through 10~ 30 seconds.
~Each 3 subjects of this placebo comparator group will match with group 1,2,3 respectively. Placebo comparator subjects in each group will be treated with same condition of each group(group 1, group 2, group 3) except being administered JW normal saline.
~Subject number: 9
~Administration time: 1day, 2day, 3day, 4day, 5day, 6day, 7day(total: 7 times)"
16172237|NCT01606150|Drug|1% lidocaine|0.1 ml/kg of 1% lidocaine injected over lumbar puncture needle insertion site 2 minutes prior to procedure
16172238|NCT01606150|Drug|topical lidocaine|1 gram placed over lumbar puncture needle insertion point 30 minutes prior to procedure
16172239|NCT01606137|Drug|GW-1000-02|Contained delta-9-tetrahydrocannabinol (THC) (27 mg/ml) and cannabidiol (CBD) (25 mg/ml) as extract of Cannabis sativa L., with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each 100 μl actuation of the pump action spray delivered 2.7 mg THC and 2.5 mg CBD. A maximum daily exposure of 130 mg THC was specified by the UK regulatory authority authorisation.
16172240|NCT01606124|Drug|defined green tea catechin extract|Given PO
16172241|NCT01606124|Other|placebo|Given PO
16172242|NCT01606124|Other|questionnaire administration|Ancillary studies
16172243|NCT01606124|Other|laboratory biomarker analysis|Correlative studies
16172244|NCT01606111|Drug|Cerebrolysin|IV infusion, 50 ml/day, 10 days (treatment cycle will be repeated one and two months later if patient has a score of less than 7 in the extended Glasgow Outcome Scale on Day 30)
16172410|NCT01604811|Drug|Permixon® 160 mg|Oral administration - 160 mg twice daily.
16172245|NCT01606111|Drug|0.9% NaCl, saline|IV infusion, 50 ml/day, 10 days (treatment cycle will be repeated one and two months later if patient has a score of less than 7 in the extended Glasgow Outcome Scale on Day 30)
16172246|NCT01606098|Procedure|Surgery of the primary tumour|Surgical resection of the colon tumour
16172247|NCT01606098|Drug|Systemic treatment|"First line fluoropyrimidine-based chemotherapy with bevacizumab. The chemotherapy regimen is to the discretion of the local investigator, who may choose between:
~5FU/LV or capecitabine or capecitabine + oxaliplatin(CAPOX)or 5FU + oxaliplatin(FOLFOX 4 or FOLFOX 7)or 5FU + irinotecan (FOLFIRI) or capecitabine + irinotecan(CAPIRI)"
16172248|NCT01606085|Behavioral|HF DM self care|Education in monitoring signs and symptoms of Heart Failure and Diabetes as well as self care instruction
16172249|NCT01606085|Behavioral|Usual Care|Educational materials on Heart Failure and diabetes at study enrollment. Full educational binder delivered at end of study.
16172250|NCT01606072|Drug|Desmopressin|20 patients in 5 groups 4 each, advancing progressively to each dose level.
16172251|NCT01606059|Drug|DW-0920|Dosage form: Extended release tablet Dosage: 2 tablets
16172252|NCT01606059|Drug|DW-0919|Dosage form: Extended release tablet Dosage: 1 tablet
16172253|NCT01606046|Device|vapocoolant spray|spray for 5 seconds from a distance of 30 cm just before the needle EMG
16172254|NCT01606046|Drug|topical anesthetic cream|application of EMLA cream on the needle electrode insertion site 60 minutes before the needle EMG
16172255|NCT01606033|Other|questionnaires|Anxiety and depression questionnaire, life quality questionnaire, adjustment strategy questionnaire, emotional regulation questionnaire, satisfaction survey
16172256|NCT01606033|Other|questionnaire|understanding of the implications of participating in a clinical trial
16172257|NCT01606020|Other|sleep deprivation|Overnight, the subjects stay in their homes (reading, watching TV, playing cards). Two experimenters will take turns to never leave them alone and avoid any micro-sleep.
16172258|NCT01606020|Other|No intervention|Overnight, the subjects stay in their homes. No intervention during this night
16172259|NCT01606007|Drug|Saxagliptin|Tablets, Oral, 5mg , Once daily, 24 weeks
16172260|NCT01606007|Drug|Metformin XR|Tablets, Oral, ≥ 1500mg/≤ 2000mg, Once daily, 24 weeks
16172261|NCT01606007|Drug|Dapagliflozin|Tablets, Oral, 10mg , Once daily, 24 weeks
16172262|NCT01606007|Drug|Placebo matching with Dapagliflozin|Tablets, Oral, 0mg, Once daily, 24 weeks
16172263|NCT01606007|Drug|Placebo matching with Saxagliptin|Tablets, Oral, 0mg, Once daily, 24 weeks
16172264|NCT01605994|Drug|BMS-933043|
16172265|NCT01605994|Drug|Placebo matching with BMS-933043|
16172266|NCT01605994|Drug|Antacid Buffer Predose Solution|
16172267|NCT01605981|Drug|AMN107|
16172268|NCT01605968|Device|BCT Silver Bandage|Activated carbon fiber impregnated with silver particles
16172269|NCT01605968|Device|Aquacel® Ag. Dressing|Antimicrobial primary dressing incorporating the unique gelling action of Hydrofiber® Technology with ionic silver for wounds that are infected or at risk of infection.
16172270|NCT01605942|Drug|Dexamethasone Drug Delivery System|Dexamethasone Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
16172271|NCT01605942|Drug|Placebo Drug Delivery System|Placebo Drug Delivery System administered into the study eye at the conclusion of cataract surgery on Day 1.
16172272|NCT01605929|Procedure|Retroclavicular Brachial Plexus Block and Catheter Insertion|A Sonosite ultrasound machine will be used to visualize the nerve and needle simultaneously. A Braun 18 g 4 inch Touhy needle with markings will be inserted into the skin and advanced toward the nerve. Once the optimal location is determined under ultrasound visualization, the local anesthetic, mepivacaine, will be injected beside the nerves. The dose of drug will be mepivacaine 1.5%, 0.5 cc/kg (with a minimum 30 cc and maximum of 50 cc.) A Braun 20 g closed tip polyamide catheter will be inserted next to the nerve and left in place to allow for additional medication to be given postoperatively.
16172273|NCT01605916|Drug|AZD6244|Tablet Oral bid
16172274|NCT01605903|Drug|Ibuprofen|Children in the ibuprofen group will be receive grape-flavored ibuprofen 100mg/5 mL. During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6.
16172275|NCT01605903|Drug|Acetaminophen|During the postoperative period, ibuprofen 10mg/kg (max dose 600 mg) will be dispensed Q6.
16172276|NCT01605890|Drug|emtricitabine / tenofovir disoproxil fumarate / raltegravir .|"emtricitabine : 200 mg/day and tenofovir disoproxil fumarate : 300 mg/day, included in one pill of Truvada® QD.
~raltegravir : 400 mg x 2/day, 400 mg in one pill of Isentress® BID."
16172277|NCT01605877|Device|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]|Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient
16172278|NCT01605864|Drug|Efficacy of ceftaroline|Determining the efficacy of ceftaroline compared to other cephalosporins
16172279|NCT01605851|Device|Closure, Foramen Ovale|
16172280|NCT01605825|Drug|placebo/dalfampridine-ER|Sequence A: placebo in Period 1 and dalfampridine-ER in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart
16172281|NCT01605825|Drug|dalfampridine-ER/placebo|Sequence B: dalfampridine-ER in Period 1 and placebo in Period 2. 10mg tablets, will be taken orally, twice daily approximately 12 hours apart
16172282|NCT01605799|Behavioral|IOK Killing Treatment|The IOK Killing Treatment is based on Cognitive Behavioral Therapy theory and principals and target maladaptive cognitions related to killing in war.
16172283|NCT01605799|Behavioral|Wait list control group|Participants in this group will not receive treatment; however, at the end of 6 weeks, they will be offered the option of receiving treatment.
16172284|NCT01605786|Biological|Lyophilised PEBS synthetic protein (PfPEBS)|"PfPEBS, is a synthetic polypeptide corresponding to amino acids 3112 to 3244 (131 aa) from the Pf 11.1 antigen in 3D7 parasite sequence. It is presented as lyophilised product in multi-dose vials (containing 105 μg for 3 doses of 30 μg ), looking like amorphous white powder. The vaccine is produced by SYNPROSIS in France.
~The 5μg dose vaccine will be formulated extemporaneously in aluminium hydroxide adjuvant and given as a 2-dose schedule with a 28 day interval."
16172411|NCT01604811|Drug|Tamsulosine Arrow LP|Oral administration - 0.4 mg daily.
16172412|NCT01604811|Drug|Placebo matching Permixon® 160 mg|Oral administration - twice daily.
16172413|NCT01604811|Drug|Placebo matching Tamsulosine Arrow LP|Oral administration - daily.
16172285|NCT01605786|Biological|Lyophilised PEBS synthetic protein (PfPEBS)|"PfPEBS-LSP, is a synthetic polypeptide corresponding to amino acids 3112 to 3244 (131aa) from the Pf 11.1 antigen in 3D7 parasite sequence. It is presented as lyophilised product in multi-dose vials (containing 105 μg for 3 doses of 30 μg ), looking like amorphous white powder. The vaccine is produced by SYNPROSIS in France.
~The 30 μg dose vaccine will be formulated extemporaneously in aluminium hydroxide adjuvant and given as a 2-dose schedule with a 28 day interval."
16172286|NCT01605786|Other|Rehydragel™ HPA|"Aluminium hydroxide adjuvant is being used as the adjuvant for the vaccine and will be used as the comparator in the control group. Vac4all is using Rehydragel™ (Manufacturer Reheis Inc.) which is a highly active protein adsorbent specially compounded for use as a fluid adjuvant. It has low oxide content and is carefully controlled for Al2O3 content and protein binding capacity. It has a lower viscosity than competing adjuvants, which makes it easier to process and handle.
~Subjects in the control group will be administered a 0.5 ml injection in a 2-dose schedule at 28 days interval. Each injection will contain approximately 600 µg of Al(OH)3 per injected dose corresponding to 200 µg equivalent of Al3+, similar to the amount being administered in the vaccine group."
16172287|NCT01605773|Drug|repaglinide|Dose individually adjusted and conducted according to labeling
16172288|NCT01605773|Drug|glyburide|Dose individually adjusted and conducted according to labeling
16172289|NCT01605760|Drug|immunotherapy Staloral|Staloral (R) 300 is a sublingual solution of allergen extracts for allergen immunotherapy. During a 16 day incrementally increasing dose period, patients took daily increasing doses period, patients took 1-8 drops of the 100 IR/ml extract during the first 8 days. Then, on days 9-16, patients took 1-8 drops of the 300 IR/ml extract. Next, patients received maintenance treatment consisting of five applications of eight drops (equivalent to 0.5 mL) of 300 IR/mL extract five times a week. The mean duration of the treatment was 28.2 months (range: 3-36 months).
16172290|NCT01605747|Dietary Supplement|Culturelle|one capsule 2x per day per feeding tube
16172291|NCT01605747|Dietary Supplement|Placebo|one placebo 2x per day per feeding tube
16172292|NCT01605734|Procedure|TACE|After obtaining arterial access,a diagnostic visceral arteriogram will be performed to demonstrate arterial supply to the tumor and the presence of variant arterial anatomy.After having positioned the catheter within the artery feeding tumor,the chemoembolization mixture will be infused into th e artery until stagnant flow is observed.
16172293|NCT01605734|Drug|sorafenib combined with TACE|All patients will receive Sorafenib (800 mg/day) p.o. beginning four weeks after the first TACE and every day thereafter until patient death or premature withdrawal from study
16172294|NCT01605721|Device|XIENCE PRIMETM everolimus-eluting coronary stent|"Active prospective registration of patients receiving the following stent
~: XIENCE PRIMETM"
16172295|NCT01605708|Drug|REGN846|Dose 1
16172296|NCT01605682|Dietary Supplement|Fresh berry extract.|Fresh berry extract containing 500mg, 250mg, 125mg per 60 kilos of body weight. Or placebo.
16172297|NCT01605669|Other|Tranthoracic Echocardiogram|standard measurement
16172298|NCT01605669|Device|Cardiac Ascultation Recordings with Electronic stethoscope|3M device
16172299|NCT01605656|Behavioral|Cognitive Interview|A research staff member will use a questionnaire to ask about many different health and social topics. The cognitive interview should take up to 45 minutes to complete.
16172300|NCT01605656|Behavioral|Questionnaires|"Phase I: Completion of a questionnaire about age, education level, income, and general health behaviors. This questionnaire should take about 20 minutes to complete.
~Phase II: Completion of 2 questionnaires. The first questionnaire will ask about age, education level, income, and general health behaviors. This questionnaire should take about 20 minutes to complete.
~The second questionnaire will ask about many different health and social topics. This questionnaire should take up to 45 minutes to complete."
16172301|NCT01605656|Behavioral|Focus Groups|"Phase I: There will be up to 8 women in each of the 5 focus groups.
~Participants asked questions about personal and clinic-related factors that might make it more difficult to receive pap smear screenings. Participants also asked to discuss what might make it easier or encourage women to receive pap smear screenings. The focus group discussion should last 60-90 minutes."
16172302|NCT01605630|Behavioral|Family-based family cancer literacy intervention|family based counseling and materials provided in navajo/english including digital stories
16172303|NCT01605630|Behavioral|Control|standard of care
16172304|NCT01605617|Drug|Fesoterodine fumarate|PTNS + 4mg of fesoterodine fumarate for 12 weeks
16172305|NCT01605617|Drug|Placebo|PTNS + placebo for 12 weeks
16172306|NCT01605617|Procedure|Percutaneous Tibial Nerve Stimulation (PTNS)|PTNS is an FDA-approved procedure for the diagnosis of overactive bladder, given on a weekly basis. Participants will be given PTNS + either 4mg of fesoterodine fumarate or placebo for 12 weeks, and followed by 4 weeks of washout followed by 12 weeks of PTNS + the opposite treatment (placebo or fesoterodine fumarate).
16172307|NCT01605604|Behavioral|buddhist mind fullness|there are two group one group recieve Buddhist mindfulness group intervention 8 times second group recieve nothing
16172308|NCT01605591|Procedure|the DLT bending to the right|bending the bronchial lumen of DLT 60~90 degrees in the same side with the tracheal lumen
16172309|NCT01605591|Procedure|the DLT bending to the left|bending the bronchial lumen of DLT 60~90 degree opposed to the tracheal lumen
16172310|NCT01605578|Procedure|Biopsies|Abdominal and gluteo-femoral subcutaneous adipose tissue biopsies
16172311|NCT01605565|Procedure|A nasal brushing|A nasal brushing in every nostril
16172312|NCT01605552|Behavioral|Beating the Blues (BtB)|BtB is a widely used, empirically supported, computer-based, CBT program for depression designed for use in primary care clinics. BtB utilizes an interactive, multimedia format to deliver and eight 50-minute, weekly therapy sessions. General topics covered include identifying and challenging automatic thoughts, cognitive errors, core beliefs, and attributional styles; activity scheduling; problem solving; graded exposure; task breakdown; sleep management; and relapse prevention. In addition to session work, patients are assigned homeworks that are customized to their needs and reviewed at the start of each session. A progress report, including whether the patient is experiencing suicidal ideation, is generated at the end of each session.
16172414|NCT01604798|Other|Serum proteomics|magnetic bead-based fractionation coupled with matrix-assisted laser desorption/ionization-time-of-flight mass spectrometry
16172415|NCT01604785|Drug|Propofol|Sub-anesthetic dose propofol: 0.25 mg/kg IV push to maximum dose of 30mg q5 minutes to a maximum of 5 doses
16172313|NCT01605552|Other|Usual Care|Patients randomized to usual care will be informed that they have clinically significant depressive symptoms and will be encouraged to follow-up with their primary care physicians, who will receive a letter from our team indicating that their patient has elevated depressive symptoms and was randomized to the control condition. The letter will also encourage physicians to follow-up with their patients and will provide a list of local mental health services. Like those in the intervention group, usual care patients will continue to have access to and will receive any medical and mental health services that are part of usual care in the targeted health care systems. Thus, there are no restrictions regarding the care that these patients can receive.
16172314|NCT01605539|Drug|Cannabidiol 400|Subjects in Arm CBD 400 will receive 400mg of Cannabidiol in each of the three test sessions
16172315|NCT01605539|Drug|Cannabidiol 800|Subjects in Arm CBD 800 will receive 800mg of Cannabidiol in each of the three test sessions
16172316|NCT01605539|Drug|Control|Subjects will receive a harmless, inactive pill to compare and validate the results of the other arms of the study
16172317|NCT01605526|Drug|RO5045337|Multiple escalating oral doses, Days 1-5 (1-3) of each 28-day cycle, up to 6 cycles
16172318|NCT01605526|Drug|doxorubicin|60 mg/m2 (75 mg/m2, 50 mg/m2) iv on Day 1 of each 28-day cycle, up to 6 cycles
16172319|NCT01605513|Drug|interferon|PEG-IFN-SA (new interferon) was injected subcutaneously one times per week for 12 times.
16172320|NCT01605487|Drug|Rupatadine|Rupatadine in Tab 10mg: 4 Tab.(2 Tab. of Rupatadine + 2 Tab. of Placebo) once daily during 7 days, then 14 days washout period; Placebo 4 Tab once daily during 7 days, then 14 days washout period; Rupatadine in Tab. 10mg, 4 Tab. once daily during 7 days
16172321|NCT01605487|Drug|Rupatadine|Rupatadine in Tab 10mg: 4 Tab.(2 Tab. of Rupatadine + 2 Tab. of Placebo) once daily during 7 days, then 14 days washout period; Rupatadine in Tab. 10mg, 4 Tab. once daily during 7 days,then 14 days washout period; Placebo 4 Tab once daily during 7 days
16172322|NCT01605487|Drug|Rupatadine|Placebo 4 Tab once daily during 7 days, then 14 days washout period; Rupatadine in Tab 10mg: 4 Tab.(2 Tab. of Rupatadine + 2 Tab. of Placebo) once daily during 7 days, then 14 days washout period; Rupatadine in Tab. 10mg, 4 Tab. once daily during 7 days
16172323|NCT01605487|Drug|Rupatadine|Rupatadine in Tab. 10mg, 4 Tab. once daily during 7 days,then 14 days washout period; Placebo 4 Tab once daily during 7 days, then 14 days washout period; Rupatadine in Tab 10mg: 4 Tab.(2 Tab. of Rupatadine + 2 Tab. of Placebo) once daily during 7 days
16172324|NCT01605487|Drug|Rupatadine|Placebo 4 Tab once daily during 7 days, then 14 days washout period; Rupatadine in Tab. 10mg, 4 Tab. once daily during 7 days, then 14 days washout period; Rupatadine in Tab 10mg: 4 Tab.(2 Tab. of Rupatadine + 2 Tab. of Placebo) once daily during 7 days
16172325|NCT01605487|Drug|Rupatadine|Rupatadine in Tab. 10mg: 4 Tab. once daily during 7 days, then 14 days washout period; Rupatadine in Tab 10mg: 4 Tab.(2 Tab. of Rupatadine + 2 Tab. of Placebo) once daily during 7 days, then 14 days washout period; Placebo 4 Tab once daily during 7 days
16172326|NCT01605474|Other|Patient discharged home after foley bulb placement.|The patient will be discharged home after fetal status is evaluated and noted to be reassuring. A 16 French foley bulb insufflated with 30 cc of normal saline will be placed and secured to the patient's inner thigh.
16172327|NCT01605474|Other|Inpatient|The patients will not be discharged home after assessment and placement of the foley catheter.
16172328|NCT01605461|Drug|BI 207127 NA|Single oral solution dose of BI 207127 NA combined with [14C]-BI 207127 NA
16172329|NCT01605448|Behavioral|Mindfulness Based Stress Reduction (MBSR)|8 weekly classes of meditation/yoga
16172330|NCT01605435|Drug|Ghrelin Group 1|The first two participants received placebo at baseline visit, 2 mcg/kg as a single subcutaneous dose at Visit 2, 5 mcg/kg as a single subcutaneous dose at Visit 3, and 10 mcg/Kg as a single subcutaneous dose at visit 4. There was 3-10 days between visits.
16172331|NCT01605435|Drug|Ghrelin Group 2|The next three participants received placebo at baseline visit, 5 mcg/kg as a single subcutaneous dose at Visit 2, 7.5 mcg/kg as a single subcutaneous dose at Visit 3, and 10 mcg/Kg as a single subcutaneous dose at visit 4.
16172332|NCT01605422|Other|Dietary pulses|beans, peas, chickpeas, lentils in whole or flour form
16172333|NCT01605409|Procedure|Emergency cardiopulmonary bypass under ongoing CPR|"Emergency cardiopulmonary bypass under ongoing CPR
~Emergency cardiopulmonary bypass (ECMO: lifebridge (Sorin®) or cardiohelp(Maquet®) will be initiated percutaneously ultrasound guided, during CPR efforts at the Emergency department.
~Cannulae and tubing in use will be heparin coated. ECMO flow will be set to 70ml/kgBW/min. Anticoagulation will achieved with unfractionated heparin and monitored using ACT."
16172334|NCT01605409|Procedure|Standard ACLS|"Standard ACLS Standard ACLS provided by EMS personnel according to current guidelines of the European resuscitation council.
~Transportation:
~Transport will be initiated as soon as the patient achieves ROSC in the field and transportation is feasible. All patients will be admitted to the ED at the Vienna general hospital.
~Standard Post resuscitation Management:
~After admission to the ED post resuscitation care and standardized intensive care treatment will be provided according to Utstein protocol and current standards for good clinical practice and according to ILCOR recommendations. A crossover to the ECPB group is possible, if indicated by good clinical practice. If so, it will be counted as treatment failure in the standard ACLS group.
~If no ROSC can be achieved and the patient dies in the field pathological results will be obtained if feasible."
16172335|NCT01605396|Drug|Ridaforolimus|Ridaforolimus 10 mg tablet, administered PO at a dose of 10 mg (triplet) or 30 mg (doublet) depending upon randomization, on Days 1-5, 8-12, 15-19, & 22-26 of 28-day cycle.
16172336|NCT01605396|Drug|Dalotuzumab|Dalotuzumab administered 10 mg/kg IV weekly on Days 1, 8, 15, and 22 of 28-day cycle.
16172337|NCT01605396|Drug|Exemestane|Exemestane 25 mg tablet administered PO QD.
16172338|NCT01605383|Biological|XCEL-MT-OSTEO-ALPHA|Core decompression plus XCEL-MT-OSTEO-ALPHA
16172339|NCT01605383|Procedure|Standard treatment|Isolated core decompression
16172340|NCT01605370|Drug|Nebivolol|Nebivolol 2.5 mg once daily
16172341|NCT01605370|Drug|Metoprolol succinate|Metoprolol succinate 50 mg once daily
16172416|NCT01604785|Drug|Standard Treatment|Ketorolac, Diphenhydramine and Metoclopramide
16172417|NCT01604772|Drug|Akt Inhibitor MK2206|Given PO
16172418|NCT01604772|Other|Laboratory Biomarker Analysis|Correlative studies
16172419|NCT01604759|Device|Polarized Reflectance Spectroscopy System|Fiber optic probe designed to measure polarized reflectance spectroscopy will be used to gather data from all study participants.
16172342|NCT01605357|Drug|Induced, sustained hypernatremia using hypertonic saline|"Patients in the experimental arm will receive hypertonic saline to target a serum sodium goal of 150 - 160 mmol/L. All hypertonic saline will be administered intravenously.
~Loading phase: Upon enrollment 23.4 % hypertonic saline (volume 20 cc) will be administered via a central venous catheter. A continuous infusion of 3% hypertonic saline will be administered at a rate of 30 cc per hour and titrated every six hours to target a serum sodium goal of 150-160 mmol/L.
~Maintenance phase: Titrate serum sodium to 150-160 mmol/L using continuous 3% hypertonic saline infusion.
~Discontinuation phase: After 5 days of completed therapy, begin to wean 3% hypertonic saline rate by 10cc every 6 hours. Discontinue hypertonic saline infusion after infusing at a rate of 20cc an hour for 6 hours.
~Bolus dosing of hypertonic saline and mannitol are to be administered at the discretion of the provider to treat elevated intracranial pressure based on practice guidelines"
16172343|NCT01605357|Drug|Standard of care (hypertonic saline and mannitol; serum sodium)|Bolus dosing of hypertonic saline and mannitol are to be administered at the discretion of the provider to treat elevated intracranial pressure based on practice guidelines. Hyponatremia ( serum sodium < 135 mmol/L) is to be corrected at the discretion of the provider.
16172344|NCT01605344|Drug|FOLFIRI.|All patients will receive FOLFIRI infusion on day 1 and day 15.
16172345|NCT01605344|Drug|Atorvastatin|A subjects will receive atorvastatin 20 mg orally once daily given for two weeks starting on Day -14 during PERIOD ONE. ARM A will then receive no statin during PERIOD TWO. ARM B subjects will receive no atorvastatin during PERIOD ONE. ARM B subjects will receive atorvastatin 20 mg orally once daily for two weeks during PERIOD TWO (starting on Day 2). One cycle = 28 days.
16172346|NCT01605331|Drug|sustained-release recombinant human GH (SR-rhGH)|
16172347|NCT01605318|Drug|IMMU-130|This is a Phase I/II, open-label study of IMMU-130 administered in 21-day treatment cycles, once or twice weekly for 2 consecutive weeks followed by one week of rest to patients with metastatic colorectal cancer who have been previously treated with at least one prior irinotecan-containing regimen.
16172348|NCT01605305|Drug|FOLFOX6|OXA 100mg/m2 ivgtt 2h d1 LV 400mg/m2 ivgtt 2h d1 5FU 400mg/m2 iv. d1 5FU 2.4g/m2 civ 46h
16172349|NCT01605292|Procedure|Ultrasound guidance|Real time ultrasound guidance using ultrasound probe covered in sterile plastic, visualizing radial artery while needle passage attempted.
16172350|NCT01605292|Procedure|Palpation|Manual palpation for localizing radial artery for inserting needle.
16172351|NCT01605279|Drug|Dobutamine|Patients with low SVCF in the first 12 hours of life will be randomized to receive Dobutamine or Placebo. First dose: 5 microg/k/min; second dose: 10 microg/k/min; third dose: 15 microg/k/min; forth dose: 20 microg/k/min. Dobutamine concentration will be prepared in a 20 ml syringe and the dose will be adjusted so each 0.1 ml/kg per hour increase in flow rate would deliver the corresponding step-increase in the drug infusion dose. Dose increments will be 5, 10, 15, 20 microg/kg per minute The study drug was increased in a stepwise manner every 30 minutes until the optimal SVCF was attained and maintained for 60 minutes (SVCF-OP). Treatment duration: 24 hours of postnatal age, maintaining the infusion rate which achieves the SVCF-OP.
16172352|NCT01605279|Drug|Placebo|Patients with low SVCF in the first 12 hours of life will be randomised to receive Dobutamine or Placebo (dextrose 5% in water, D5W, as Placebo)
16172353|NCT01605253|Drug|Eszopiclone|Eszopiclone has been approved by the US Food and Drug Administration (FDA) for the treatment of insomnia (inability to sleep). Eszopiclone has not been specifically approved by the FDA for people who have PTSD-related sleep disturbance.
16172354|NCT01605253|Drug|Placebo|The placebo used in this study looks exactly like eszopiclone but contains no active ingredients.
16172355|NCT01605240|Drug|Acetaminophen and Ibuprofen|After their fracture is reduced, these patients will receive acetaminophen (15mg/kg) and ibuprofen (10mg/kg) at regular dosing intervals.
16172356|NCT01605240|Drug|Acetaminophen and Codeine|After their fracture is reduced, these patients will receive acetaminophen (15mg/kg) and codeine (1mg/kg) at regular dosing intervals.
16172357|NCT01605227|Drug|cabozantinib|Tablets taken orally once-daily
16172358|NCT01605227|Drug|prednisone|Taken twice a day orally. Commercially-obtained prednisone tablets will be over-encapsulated in order to blind identity.
16172359|NCT01605201|Biological|Tissue engineered cartilage graft|Autologous nasal chondrocytes expanded in vitro and cultured in a collagen type I//III scaffold
16172360|NCT01605162|Drug|TMZ|TMZ (at 150 mg/m2) will be administered orally according to the instructions on the product label, on Days 1 through 5 of the same 28-day cycle as E7016. TMZ capsules should be taken immediately after E7016. No food or drink intake, except water, will be allowed for 2 hours before or after administration.
16172361|NCT01605162|Drug|E7016|"E7016 capsules will be administered in the morning after at least a 2-hour fast. Subjects will be instructed not to eat or drink anything except water in the 2 hours prior and 2 hours after drug administration. Subjects will record the time at which they ate.
~For the Single-Dose PK Period, 320 mg of E7016 will be administered once on Day -2. For the Multiple-Dose Treatment Cycle(s), 320 mg E7016 will be administered QD on Days 1 through 7 of each 28-day cycle."
16172362|NCT01605136|Drug|Afamelanotide|One 16mg subcutaneous implant every 2 months for 6 months.
16172363|NCT01605136|Drug|Placebo|One placebo subcutaneous implant every 2 months for 6 months
16172364|NCT01605110|Drug|Hyperbaric oxygen treatment|Patients that volunteer to participate in this study will be exposed to two treatments (one before surgery; one after surgery) of 100% oxygen at 2.0 atmospheres absolute (ATA) inside mono-place chambers for 90 minutes (at depth).
16172365|NCT01605110|Drug|Air sham|Patients that volunteer to participate in this study will be exposed to two treatments (one before surgery; one after surgery) of medical grade air (21%oxygen; sham) at 1.2 ATA inside mono-place chambers for 90 minutes.
16172366|NCT01605097|Radiation|HDR interstitial brachytherapy|2 treatments of 1000 cGy will be delivered to the entire prostate volume while escalating the dose to the visible disease to 1250 cGy
16172367|NCT01605084|Drug|Atazanavir|Capsule, Oral, 300 mg, Once daily (QD), 48 weeks
16172368|NCT01605084|Drug|Darunavir|Oral, Two 400 mg Tablets, Once daily (QD), 48 weeks
16172369|NCT01605084|Drug|Ritonavir|Tablet, Oral, 100 mg, Once daily (QD), 48 weeks
16172420|NCT01604746|Biological|Ross River Virus (RRV) Vaccine|Not applicable, no vaccine will be administered in this study. The RRV vaccine was administered in the precursor study.
16172448|NCT01604382|Drug|General Anesthesia|General Anesthesia as described above
16172484|NCT01604057|Drug|ZT-034 High Dose Nasal Spray|Nasal Spray
16172370|NCT01605084|Drug|Optimized NRTI backbone|"tablet/capsule, Noninvestigational products i.e. NRTI backbone will be administered according to their respective package inserts for 48 weeks
~NRTI backbone are:
~- Abacavir (300 mg), Tenofovir (300 mg), Didanosine (250 mg or 400 mg), Stavudine (30 mg or 40 mg), Emtricitabine (200 mg), Lamivudine (300 mg), Zidovudine (300 mg), EPZICOM® (600 mg Ziagen® + 300 mg Lamivudine), COMBIVIR® (150 mg Lamivudine + 300 mg Zidovudine)
~The following NRTI combinations are prohibited in this study:
~Didanosine + Stavudine
~Zidovudine + Stavudine
~Lamivudine + Emtricitabine"
16172371|NCT01605071|Drug|Estradiol|"1 week of transdermal estradiol (0.15mg)
~1 week of transdermal placebo"
16172372|NCT01605045|Other|Fluoroscopy-save group|Coronary anatomy visualized under fluoroscopy, documented using the fluoroscopy-save function, and further visualized using cinematography only when higher quality is necessary (fluoroscopy-save technique) versus Coronary anatomy visualized and documented using cinematography alone (standard technique)
16172373|NCT01605045|Other|Standard technique|Coronary anatomy visualized under fluoroscopy, documented using the fluoroscopy-save function, and further visualized using cinematography only when higher quality is necessary (fluoroscopy-save technique) versus Coronary anatomy visualized and documented using cinematography alone (standard technique)
16172374|NCT01605032|Drug|Busulfan|Given IV
16172375|NCT01605032|Drug|Melphalan|Given IV
16172376|NCT01605032|Drug|Bortezomib|Given IV
16172377|NCT01605032|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo autologous PBSCT
16172378|NCT01605032|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo autologous PBSCT
16172379|NCT01605019|Device|CoSeal|3 - 8mls of Coseal
16172380|NCT01605019|Device|BioGlue® Surgical Adhesive|Total amount applied - 8 mls
16172381|NCT01605006|Device|NeuRx Diaphragm Pacing System (DPS)|The NeuRx DPS is a percutaneous, intramuscular, diaphragm stimulation system which is implanted using standard laparoscopic surgical techniques in an outpatient procedure. The implanted intramuscular diaphragm electrodes are connected to a four channel external stimulator at a percutaneous exit site. DPS is designed to help ALS patients breathe by providing conditioning stimulation of the diaphragm muscles. Recommended frequency of diaphragm conditioning is at least 3 times per day with each session lasting at least 30 minutes. Patients may find it helpful to use the DPS for longer periods to help with breathing. DPS may be used at the same time as non-invasive ventilation. Patents may also sleep with the DPS to assist with breathing difficulties at night.
16172382|NCT01604993|Other|Spinach soup|556 g of high Nitrate spinach soup that is orally consumed as a single dose for 7 days
16172383|NCT01604993|Other|Asparagus soup|556 grams of low nitrate asparagus soup that is orally consumed for a period of 7 days as a single does
16172384|NCT01604980|Dietary Supplement|Protein intake.|protein intakes will be varied at 0.2, 0.5, 0.7, 0.9, 1.0, 1.2, 1.5, 1.8 and 2.0g/kg/day
16172385|NCT01604954|Behavioral|Nutrient-label|A label indicating that the lunch they will eat is low in saturated fat and free from trans fat will be posted on the containers.
16172386|NCT01604954|Behavioral|Calorie-label|"A label indicating the amount of calories for a fixed serving plus information about daily caloric requirement (The recommended daily caloric intake for an average adult is 2000 calories) will be posted on the containers."
16172387|NCT01604954|Behavioral|No label|Lunches will be free from labels, so that no nutritional information will be provided to the participants(control group).
16172388|NCT01604941|Drug|SPD602|50 mg/kg/day orally twice daily for 24 weeks
16172389|NCT01604928|Drug|YM178|Oral
16172390|NCT01604928|Drug|tolterodine|Oral
16172391|NCT01604928|Drug|Placebo|Oral
16172392|NCT01604915|Procedure|Caudal block|After inhalation induction of general anesthesia, caudal block was applied. Patients were randomly assigned in two groups. Normal saline 0.02mL/Kg added to ropivacaine 0.15% 1.5ml/kg was administered to Group R.
16172393|NCT01604915|Procedure|Caudal block|After inhalation induction of general anesthesia, caudal block was applied. Patients were randomly assigned in two groups. Dexamethasone 0.1mg/kg added to ropivacaine 0.15% 1.5ml/kg to Group DR.
16172394|NCT01604902|Other|4 mm punch biopsies|4 mm punch-biopsies from lesional and non-lesional psoriatic skin at day 0 and up to four times after treatment at the following days: 4, 14, 28 or 84.
16172395|NCT01604889|Drug|Epacadostat|
16172396|NCT01604889|Drug|Placebo|Placebo
16172397|NCT01604889|Drug|ipilimumab|ipilimumab 3 mg/kg IV
16172398|NCT01604889|Drug|ipilimumab|Doses to be determined following the completion of Phase I of the study
16172399|NCT01604876|Device|light therapy 30 min morning and evening, three months|"Light from a commercially available table-mounted lightbox (Brazil, Lumie, Cambridge UK) [dimensions 50.2 x 32 x 15.4 cm] equipped with 3x36W Fluorescent bulbs (Osram 954), reflectors and a diffuser screen providing 10,000 lux at 30 cm eye level distance.
~therapy consists of 30 minutes light exposure in the morning and evening during 3 months."
16172400|NCT01604876|Device|light therapy 30 min morning and evening, three months|"200 lux light from a commercially available table-mounted lightbox (Brazil, Lumie, Cambridge UK) [dimensions 50.2 x 32 x 15.4 cm] To lower the intensity to 200 lux the bulbs are enwrapped with one layer of L299s neutral density filter (LEE Filters, Andover, UK).
~Therapy consists of 30 minutes light exposure in the morning and evening during 3 months."
16172401|NCT01604863|Drug|HGS1036 + Paclitaxel + Carboplatin|HGS1036 10 or 20 mg/kg, IV once weekly in each 21-day cycle. Paclitaxel 175 mg/m2 or 200 mg/m2, IV and carboplatin AUC 6.0 mg∙min/mL, IV every 3 weeks on Day 1 of each 21-day cycle.
16172402|NCT01604863|Drug|HGS1036 + Cisplatin + Etoposide|HGS1036 10 or 20 mg/kg, IV once weekly in each 21-day cycle and cisplatin 60-80 mg/m2, IV on Day 1 and etoposide 100-120 mg/m2, IV on Days 1, 2, and 3 of each 21 day cycle.
16172403|NCT01604863|Drug|HGS1036 + Docetaxel|HGS1036 10 or 20 mg/kg, IV once weekly in each 21-day cycle and docetaxel 75 mg/m2, IV on Day 1 of each 21-day cycle.
16172404|NCT01604850|Drug|SOF|Sofosbuvir (SOF) 400 mg tablet was administered orally once daily.
16172405|NCT01604850|Drug|RBV|Ribavirin (RBV) tablets was administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
16172406|NCT01604850|Drug|Placebo to match SOF|Placebo to match SOF was administered orally once daily.
16172407|NCT01604850|Drug|Placebo to match RBV|Placebo to match RBV was administered orally twice daily.
16172408|NCT01604824|Drug|Alirocumab|SC injection in the abdomen
16172421|NCT01604707|Other|Medical Yoga|Patients were randomly allocated to a control group receiving standard care, or a yoga group treated with Medical yoga for 1 hour, once a week, over a 12-week period in addition to the standard care.
16172422|NCT01604694|Procedure|TAP Block|An Ultra Sound-guided TAP block is performed after induction of general anesthesia prior to surgical incision. The syringes containing either saline 20 ml (placebo group) or levobupivacaine 20 ml are prepared by the hospital pharmacy under aseptic conditions.
16172423|NCT01604681|Dietary Supplement|Placebo|6 capsules per day, thirty minutes before lunch and dinner, eating 3 capsules (3 g) at a time.
16172424|NCT01604681|Dietary Supplement|Flaxseed Oil|6 capsules per day, thirty minutes before lunch and dinner, eating 3 capsules (3 g) at a time.
16172425|NCT01604655|Procedure|Coronary CT Angiography|CCTA
16172426|NCT01604655|Procedure|Stress Test|Stress Test
16172427|NCT01604642|Other|blood tests and muscular biopsies|blood tests and muscular biopsies
16172428|NCT01604629|Drug|Reduced doses of anti-TNF|Standardized schedule of reduced doses of anti-TNF, reached either through the interval spacing of administration (adalimumab, etanercept or golimumab) or reducing doses of infliximab
16172429|NCT01604629|Drug|Stable doses of anti-TNF|Stable doses of anti-TNF according clinical practice based on approved summary product characteristics (SPC) and SER consensus about biological therapies in Ankylosing Spondylitis and other Spondylarthropathies, except Psoriatic Arthritis
16172430|NCT01604590|Radiation|Magnetic Resonance Imaging (MRI)|Magnetic Resonance Imaging (MRI) will be used to compare bevacizumab to the images of vessel and tumor structure.
16172431|NCT01604577|Behavioral|interactive educational intervention|Use of a concise, literacy-sensitive, physician-led, educational interaction with the patient.
16172432|NCT01604525|Behavioral|Tailored Web|The tailored website included 6 weeks of content about making healthy lifestyle choices, eating breakfast, exercising, reducing drinking and quitting smoking. Each week, participants were asked to check in with their past week's behavior, and to set goals for the next week's check-in.
16172433|NCT01604525|Behavioral|Peer Coaching|Participants chose a peer coach, who reviewed the participant's check-in data and goals, and provided personalized feedback to help the participant reach those goals. Interaction took place via personalized videos recorded each week and uploaded to a participant's web profile, and through pro-active phone calls to the participants each week.
16172434|NCT01604525|Other|Untailored Web|Content about lifestyle issues (music, travel, dating) was created for participants assigned to the control group. There was new web content each week for 6 weeks.
16172435|NCT01604512|Diagnostic Test|MRI perfusion and PET/CT scans|The MRI perfusion and PET/CT scans will be obtained within 12 weeks of each other. These scans are part of the standard of care for patients with brain tumors and uncertain tumor response or progression after treatment. Although every effort will be made to perform both MRI perfusion and PET/CT on the same day or during the same week, some patients may experience longer intervals between scans due to scheduling conflicts. The disease in question (radiation injury vs. tumor progression) may change slightly during this interval (e.g., the lesion may grow or shrink slightly), but no large changes are expected between the two scans. The patients may continue existing treatments in the interval between scans (e.g., steroids, chemotherapy), but the two scans must be performed before any change or new treatment occurs. Fusion images of MRI and PET/CT will not be reviewed by the neuroradiologist interpreting the MRI perfusion nor the nuclear medicine radiologist interpreting the PET/CT.
16172436|NCT01604499|Behavioral|Feedback letters|"Subjects receive feedback letters about the proportion of green, yellow, and red purchases in the cafeteria per month with comparisons to all employees and to the healthiest employees eaters"
16172437|NCT01604499|Behavioral|Feedback plus incentives|Subjects receive feedback letters plus small incentives to increase healthy (green-labeled) purchases in the next month
16172438|NCT01604460|Procedure|Resuscitation with torso plastic bag|Infant will be placed within 10 minutes of his birth into a plastic bag to his/her axillae and the bag will be folded and taped to itself to prevent it from covering the infant's nose or mouth. After his/her head is dried, the infant will receive a cloth cap. Resuscitation will occur in the delivery room and the infant will be wrapped in a blanket and taken to the nursery where he/she will remain in the plastic bag until 1 hour after birth.
16172439|NCT01604460|Procedure|Resuscitation-no plastic bag|Infant will be immediately dried and resuscitated in the delivery room per standard of care. The infant will be wrapped in a blanket and will receive a cloth hat before being taken to the nursery.
16172440|NCT01604447|Procedure|Hypothermia prevention with plastic bag|Upon removal from the incubator, infant will be placed into a plastic bag to his/her axillae, and the bag will be folded and taped to itself to prevent it from covering the infant's nose or mouth. The infant will be wrapped in a blanket and receive a cloth hat. The bag will be changed when soiled and the infant will remain in the bag for 72 hours or until discharge, whichever comes first. The infant's temperature will be monitored for 72 hours or until discharge, whichever comes first.
16172441|NCT01604447|Procedure|Hypothermia prevention without plastic bag|Upon removal from incubator, the infant will be wrapped in a blanket and receive a cloth hat, according to standard bundling practices. The infant's temperature will be monitored for 72 hours or until discharge, whichever comes first.
16172442|NCT01604434|Procedure|Incubator-torso bag|While being placed into an incubator, infant will be placed into a plastic bag to his/her axillae and the bag will be folded and taped to itself to prevent it from covering the infant's nose or mouth. The infant will be wrapped in a blanket over the plastic bag and will receive a cloth hat. He/she will remain in the bag for one hour.
16172443|NCT01604434|Procedure|Incubator-no plastic bag|Infant will be placed in the incubator, wrapped in a blanket, with a cloth hat, according to standard protocol.
16172444|NCT01604421|Procedure|Thermoregulation-standard care|Standard care without plastic bag. One hour after birth, a blanket will be wrapped around the infant and he/she will receive a wool hat, according to standard practices. The infant's axillary temperature will be monitored for 24 hours or until discharge, whichever comes first.
16172445|NCT01604421|Procedure|Thermoregulation with plastic bag|One hour after birth, the infant will be placed into a plastic bag up to his/her axillae, and the bag will be folded and taped to itself to prevent it from covering the infant's nose or mouth. A blanket will be wrapped around the infant, and he/she will receive a wool hat. The infant will remain in the bag, which will be changed when soiled, for 24 hours or until discharge, whichever occurs first.
16172446|NCT01604408|Biological|LY2495655|Administered SC
16172449|NCT01604382|Drug|Neuraxial anesthesia|Neuraxial anesthesia as described above
16172450|NCT01604369|Procedure|Medtronic Freezor Max Cardiac Cryoablation Catheter|Cryoablation is performed using a sequential application technique point-by-point from the tricuspid annulus to the inferior vena cava. Ablation is performed at a target temperature of -80 ºC. Each application will last for 240 seconds.
16172451|NCT01604356|Procedure|Electro-acupuncture|Ten treatment sessions at our center during a two week period (5 sessions per week). Each session will last approximately 30 minutes. The intervention will involve the placement of acupuncture needles in a standard set of points across all patients, located on the head, around the eyes, on the abdomen, on the hands, feet, arms and legs. An electro-acupuncture device [Transcutaneous electrical nerve stimulator (TENS) unit by Lhasa OMS Inc.; model AWQ-104L] and will be used on four of the acupuncture points (two per session) located on the forehead, and side of the face/temple.
16172452|NCT01604343|Drug|Placebo|Form=solution for injection, route=subcutaneous use; every 2 weeks from Week 0 through Week 50.
16172453|NCT01604343|Drug|Placebo|Form=solution for injection, route=subcutaneous use; Weeks 2, 6, and every 4 weeks through Week 104.
16172454|NCT01604343|Drug|Sirukumab|Type=exact, unit=mg, number=50 or 100, form=solution for injection, route=subcutaneous use; every 2 weeks for 100 mg and every 4 weeks for 50 mg, Week 52 through Week 104.
16172455|NCT01604343|Drug|Sirukumab|Type=exact, unit=mg, number=100, form=solution for injection, route=subcutaneous use; Weeks 0, 2, and every 2 weeks through Week 104.
16172456|NCT01604343|Drug|Sirukumab|Type=exact, unit=mg, number=50, form=solution for injection, route=subcutaneous use; Weeks 0, 4, and every 4 weeks through Week 104.
16172457|NCT01604330|Drug|Baclofen|Baclofen will be administered orally for a maximum of 52 consecutive weeks. For the first 3 days, patients will receive baclofen in a dose of 5 milligrams three times a day; then the dose of baclofen will be increased to a maximum of 300 milligrams a day. In case of intolerance, dosage can be decreased.
16172458|NCT01604330|Drug|Placebo|Sugar pill will be administered orally for a maximum of 52 consecutive weeks. For the first 3 days, patients will receive sugar pill in a dose of 5 milligrams three times a day; then the dose of sugar pill will be increased to a maximum of 300 milligrams a day. In case of intolerance, dosage can be decreased.
16172461|NCT01604304|Procedure|flexible ureteroscopy|Flexible ureteroscopy will be use for 120 min max to treat renal stone. Laser, access sheath, baskets can be use to perform the technique.
16172462|NCT01604304|Procedure|extracorporeal shockwave lithotripsy|The lithotriptor is use with 1,1 Hz frequency and stop when patient get 1000 joules of energy or if there is a problem with tolerance of this treatment or if stone is broken
16172463|NCT01604278|Drug|NVA237 50 µg and indacaterol 150 µg|NVA237 50 µg and indacaterol 150 µg supplied as blistered capsules for inhalation.
16172464|NCT01604278|Drug|Placebo to NVA237 and indacaterol 150 µg|Placebo to NVA237 and indacaterol 150 µg supplied as blistered capsules for inhalation.
16172465|NCT01604265|Drug|Placebo|Contained peppermint oil, 0.05% (v/v), quinoline yellow, 0.005% (w/v), sunset yellow, 0.0025% (w/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl. The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
16172466|NCT01604265|Drug|Sativex|Contained delta-9-tetrahydrocannabinol (THC), (25 mg/ml):cannabidiol (CBD), (25 mg/ml) as extract of Cannabis sativa L., with peppermint oil, 0.05% (v/v), in ethanol:propylene glycol (50:50) excipient. Each actuation delivered 100 μl (THC 2.5 mg and CBD 2.5 mg). The maximum permitted dose of study medication was eight actuations in any three hour period, and 48 actuations in any 24 hour period.
16172467|NCT01604239|Drug|Shinbaro Capsule|600mg twice a day (b.i.d) oral herbal medicine
16172468|NCT01604213|Drug|Metformin plus vildagliptin|Oral Metformin 850mg and vildagliptin 50mg, qd initially, up-titrated to BID if clinically necessary
16172469|NCT01604213|Drug|Metformin only|Oral Metformin 850mg QD, up-titrated to 850mg TID is clinically indicated
16172470|NCT01604200|Behavioral|focus group|key informant review
16172471|NCT01604187|Drug|Fentanyl|Ten minutes before the procedure fentanyl sublingual tablet (Abstral ® 100 µg, ProStrakan) will be given to the patient.
16172472|NCT01604187|Drug|Placebo|Ten minutes before the procedure placebo sublingual tablet will be given to the patient.
16172473|NCT01604174|Other|Interactive Virtual Telerehabilitation (IVT)|Rehabilitation after arthroplasty of knee using IVT
16172474|NCT01604174|Other|Standard care rehabilitation|Standard care rehabilitation after total knee arthroplasty
16172475|NCT01604161|Drug|somatropin|Collection of safety and efficacy data in connection with use of somatropin (Norditropin®) in daily clinical practice.
16172476|NCT01604135|Device|Corneal Collagen Crosslinking|Keratoconic corneas that show significant progression as specified in the inclusion criteria section will receive one single treatment with CXL if randomized to the treatment arm. A treatment protocol based on 30 minutes dropping with riboflavin/dextran solution and 10 minutes UV-illumination treatment will be used.
16172477|NCT01604122|Other|No drug|No drug.
16172478|NCT01604122|Other|No drug|No drug.
16172479|NCT01604109|Drug|10 % w/v CPP-ACP paste|Apply once a day at school by school teacher, following fluoride toothbrushing after lunch
16172480|NCT01604109|Drug|the paste without CPP-ACP|Apply once a day at school by school teacher, following fluoride toothbrushing after lunch.
16172481|NCT01604096|Other|Multifaceted information campaign|"Following is the description of the multifaceted intervention:
~brochures targeted at the general population and available in general practices, pharmacies, local health services and on the web (also translated in eight languages)
~posters (same distribution as brochures)
~short videos transmitted in local TVs, websites of Local Health Authorities and in video terminals in some pharmacies
~radio-spots transmitted in local radio stations
~advertisements in local newspapers
~banners on websites of local newspapers
~newsletter on antibiotic resistance in Emilia- Romagna, available to physicians and pharmacists
~training courses in counselling strategies, directed to a subgroup of GPs and paediatricians"
16172482|NCT01604057|Drug|ZT-034 Low Dose Nasal Spray|Nasal Spray
16172485|NCT01604057|Drug|Teriparatide|20 mcg subcutaneous daily
16172486|NCT01604057|Drug|Placebo|Nasal Spray
16172487|NCT01604044|Drug|Meropur 150 a day|one subcutaneous injection a day
16172488|NCT01604044|Drug|Gonal-f 150 plus Luveris 150|one subcutaneous injection a day
16172489|NCT01604031|Biological|B-CLL Vaccine|Patients will receive a fixed dose (2X10^7) of IL-2 secreting B-cells together with (2X10^7) of hCD40L expressing B-cells. Patients will receive doses of vaccine at 2 week intervals for 5 doses. Barring adverse events, an additional 11 doses of vaccine will be given, at 4 weekly intervals beginning on week 12 for a total period of one year or 16 vaccinations in total.
16172490|NCT01604031|Drug|Lenalidomide|Subjects will begin lenalidomide 5 mg orally daily on day zero and will continue daily dosing until week 60 (4 weeks after the final dose of vaccine).
16172491|NCT01604005|Radiation|Prophylactic Irradiation of Tracts (PIT)|21 Gy in 3 fractions
16172492|NCT01603979|Biological|AV-203|The antibody AV-203 is a humanized immunoglobulin G1/kappa (IgG1/κ) monoclonal antibody that targets the receptor tyrosine kinase (RTK) ERBB3 and inhibits ERBB3 activities. AV-203 will be administered as a 60 to 75-minute IV infusion once every 2 weeks until disease progression or unacceptable toxicity.
16172493|NCT01603940|Drug|Benazepril|Patients in this group will receive 20 mg of benazepril per day, orally, during 12 weeks.
16172494|NCT01603940|Drug|Losartan|Patients in this group will receive 100 mg of losartan per day, orally, during 12 weeks.
16172495|NCT01603927|Device|Narrow band imaging for 'optical diagnosis' of colonic polyps (Olympus).|Colonoscopists will narrow band imaging to provide an 'optical diagnosis' for colonic polyps found during routine colonoscopies performed for the diagnosis of symptoms or asymptomatic screening.
16172496|NCT01603914|Device|central venous catheter replacement (Arrowgard Blue plus Quad-Lumen CVC )|"Routine practices for the type of catheter of each participating Unit will be respected. Multilumen central venous catheter will be used (i.e Arrowgard Blue plus Quad-Lumen CVC set). Impregnated Catheter with antiseptics or with antibiotics will be allowed.The anatomical locations selected for the replacement of central venous catheter are: subclavian vein, internal jugular vein, femoral vein and the change will be addressed according to the randomization.
~The dressing and maintenance of the catheter will be guided according with the Guides of The Centers for Disease Control and Prevention (CDCs) and a check-in lists will be fill in for each catheter.
~A pre-defined stratified analysis will be performed according with: type of catheter, participating unit, and insertion site."
16172497|NCT01603901|Device|Regulated Negative Pressure-Assisted Wound Therapy Device|Negative pressure will be applied in the usual way that is normally applied in our Medical Center
16172498|NCT01603888|Other|no intervention|
16172499|NCT01603875|Biological|New Chromatographically Purified Vero-cell Rabies vaccine(new CPRV).|new CPRV 0.1 ml intradermal route and 0.5 ml intramuscular route are the experimental intervention
16172500|NCT01603862|Procedure|ThinkingFit programme|Combined physical, cognitive and social stimulation activties.
16172501|NCT01603849|Radiation|Prophylactic Cranial Irradiation|Patients allocated to this arm will received treatment with whole brain radiotherapy 25 Gy in 10 fractions.
16172502|NCT01603836|Biological|bone allogaft with bone marrow concentrate|In forty cases, the PLF was done with spongious allograft chips alone (Group I). In another forty cases, spongious allograft chips were mixed with BMC (Group II), where the mesenchymal stem cell (MSCs) concentration was 1.74 x104/L at average (range, 1.06-1.98 x104/L). Patients were scheduled for anteroposterior and lateral radiographs at 12 and 24 months after the surgery and for CT scanning at 24 months after the surgery. Fusion status and the degree of mineralization of the fusion mass were evaluated separately by two radiologists blinded to patient group affiliation.
16172503|NCT01603784|Behavioral|Intensive Exercise|"Standardized aerobic training program that is individualized to each participant's fitness level, and supervised by a certified exercise specialist. Participants attend 3 training sessions per week for 6 months. The session begins with a 10-15 minute warm-up. Participants then exercise on a treadmill or stationary bike, followed by cool-down activities. Heart rate and rating of perceived exertion are used to evaluate exercise intensity. Participants begin at ~30 min/day 60-70% of HR max and/or an equivalent level of RPE, and progress to 45-50 minutes at 75-85% for HR max."
16172504|NCT01603784|Behavioral|Home Exercise|Exercise program consisting of stretching, range of motion, and simple yoga exercises designed to improve flexibility. Each participant has a 60-minute sessions with an exercise trainer to teach them how to perform the exercises correctly. They are also given diagrams illustrating the exercises, along with written instructions. They are instructed to perform these exercises at home at least 3 times per week for 30 - 45 minutes. They also go to the recreational center monthly to meet with an exercise trainer to ensure that they are doing the exercises correctly. Participants record their exercise activities on a calendar for the 6 months.
16172505|NCT01603784|Behavioral|Cognitive Training|Computer-based training that is is administered 3 days per week for 8 weeks during months 5 and 6. The training program focuses on 3 types of cognitive processes: task coordination, prospective memory, and retrospective memory retrieval. One day of the week is devoted to each of the three cognitive processes. Some training sessions include a homework assignment for application and practice of the target cognitive processes in everyday activities.
16172506|NCT01603784|Behavioral|Health Education|"Weekly educational sessions are administered during months 5 and 6, conducted at the recreational center by research staff. Sessions last 1 hour, and cover health and other topics unrelated to exercise or cognition, such as nutrition, hearing loss, stroke, and saving energy in one's home. At the completion of each session, participants are given a homework assignment."
16172507|NCT01603771|Other|Blood Oxygen Level Dependent (BOLD) functional magnetic imaging (fMRI)|All participants complete MRI scans at baseline and at the end of month 6. Scanning sessions last approximately 30 minutes each and consist of two components: (1) High resolution T1-weighted MPRAGE anatomic images to provide detailed anatomy and maximum gray-white matter contrast for images and to allow any estimate of regional or whole-brain volume, and (2) Resting BOLD functional images to allow assessment of the functional connectivity in large scale networks.
16172508|NCT01603758|Drug|Ezetimibe|Ezetimibe 10 mg/day or placebo will be given for 6 weeks
16172509|NCT01603719|Dietary Supplement|new infant formula with prebiotics and beta-palmitate|experimental infant formula as sole source of nutrition over first 12 weeks of life
16172699|NCT01602367|Drug|Placebo matching with BMS-823778|Capsules, Oral, 0 mg, Once daily, 12 weeks
16172700|NCT01602341|Drug|AN2728 Topical Ointment, 2% QD|AN2728 Topical Ointment, 2% QD
16172510|NCT01603563|Behavioral|Stepped Care TF-CBT|Stepped Care TF-CBT patients will receive step one: 3 (1 hr.) in-office therapist-led sessions over 6 weeks, the parent-child workbook (Stepping Together), scheduled weekly phone meetings (15 minutes), and information from the National Child Traumatic Stress Network website (via web or paper for those without access). Children who do not meet responder status will receive step two: 9 (1 to 1.5 hr.) in-office therapist-directed sessions of TF-CBT over 6 to 8 weeks.
16172511|NCT01603563|Behavioral|Standard TF-CBT|Standard TF-CBT patients will receive 12 (1 to 1.5 hr.) standard weekly in-office therapist-directed sessions over 12 to 14 weeks (Phase II only). The 2 additional weeks allow for scheduling difficulty. Standard TF-CBT includes child, parent and conjoint parent-child sessions addressing the core trauma treatment components discussed in section a.3 (e.g. stress management, skill building, gradual exposure, & trauma narrative etc.).
16172512|NCT01603550|Other|Sleep Deprivation|Sleep Deprivation
16172513|NCT01603550|Other|Energy Restriction|Energy Restriction
16172514|NCT01603524|Other|OMSC Group|"The OMSC Group will receive a multi-component intervention which includes:
~Coaching and Outreach Facilitation Visits: Each practice will receive on-site support to implement the intervention components.
~Practice tools and real time prompts: Practices will be provided with 4 tools to support the integration of evidence-based cessation practices into brief clinical encounters as part of a practice-level strategy.
~Provider Training in Smoking Cessation Interventions: All clinic providers will be invited to a 3 hour training workshop on smoking cessation(CME).
~Telephone follow-up support program: Clinics will be able to refer smokers embarking upon a quit attempt to the smoker's telephone follow-up counseling program."
16172515|NCT01603524|Behavioral|OMSC + Performance Feedback Group|The OMSC + Performance Feedback Group will receive the same intervention program as the OMSC group. In addition, clinicians will complete a one-hour audit and feedback session prior to the implementation of the OMSC program at their clinic. The goal of the audit and feedback is to increase provider self-efficacy in the delivery of smoking cessation interventions, raise awareness of the current delivery of evidence-based cessation practices, identify areas for improvement, and motivate providers to deliver evidence-based treatments.
16172516|NCT01603511|Device|Rewarming modality|A commercial charcoal heater will be applied to the torso or the head in two of the trials. The control trial involves shivering only.
16172517|NCT01603498|Drug|Dexamethasone|Dexamethasone 8mg
16172518|NCT01603498|Drug|Methylprednisolone|Methylprednisolone 40mg
16172519|NCT01603407|Drug|Prednisone|daily prednisone (0.75 mg/kg/day) tablets for 36-60 months
16172520|NCT01603407|Drug|Prednisone|intermittent prednisone (0.75 mg/kg/day, 10 days on, 10 days off) tablets for 36 to 60 months
16172521|NCT01603407|Drug|Deflazacort|daily deflazacort (0.9 mg/kg/day) tablets for 36-60 months
16172522|NCT01603810|Other|OCT|Optical coherence tomography of periocular basal cell carcinoma
16172523|NCT01603797|Behavioral|Guided internet-delivered acceptance and commitment therapy|The treatment program consisted of seven sections and was based on ACT.The first part was about creative hopelessness and was followed in the next section by an introduction to willingness and to the process of acceptance of pain. Information and assignments about committed action and values were also part of the treatment program. Mindfulness exercises were a regular feature in the program. The last part was about how to maintain learned strategies but also an evaluation of the program.
16172524|NCT01603745|Drug|Zoely|1 pill every day
16172525|NCT01603745|Drug|Yasmin|1 pill every day
16172526|NCT01603706|Procedure|Echo guided implantation group|Lead placement according echo strain imaging result
16172527|NCT01603693|Device|Bio-Oss (by Geistlich)|Guided Bone Regeneration (GBR) will be done with no changes from the common (Dahlin 1988). Patients will be given local anasthesia, full thickness mucoperiosteal flap will be raised to expose the bone area that needs augmentation, bone substitute will be placed over the bony crater and covered with a collagen membrane (Bio-Gide, geistlich, FDA and CE approved). Mucoperiosteal flap will be sutured and patients will be instructed to a check-up routine as accepted after this kind of procedure.
16172528|NCT01603693|Device|BondBone (by Augma)|Guided Bone Regeneration (GBR) will be done with no changes from the common (Dahlin 1988). Patients will be given local anasthesia, full thickness mucoperiosteal flap will be raised to expose the bone area that needs augmentation, bone substitute will be placed over the bony crater and covered with a collagen membrane (Bio-Gide, geistlich, FDA and CE approved). Mucoperiosteal flap will be sutured and patients will be instructed to a check-up routine as accepted after this kind of procedure.
16172529|NCT01603680|Procedure|Circumferential spread of the mepivacaine ultrasonographic guided around the median and ulnar nerves at the elbow|Homogeneous spread of 6 ml of mepivacaine 1% around the median and ulnar nerves in each one using several needle passes and active hydrodissection
16172530|NCT01603680|Procedure|Non circumferential spread in ultrasound-guided median and ulnar nerves block|Asymmetric spread of 6 ml of mepivacaine 1% in contact with median and ulnar nerves block in each one, using only one needle pass
16172531|NCT01603667|Drug|PG2|"STUDY DRUG DOSAGE:IV infusion of PG2 Injection 500 mg in 500 ml Normal Saline at a rate of 200 mg/hr with infusion started within 3-6 hrs of stroke onset and infusion of a total of 500 mg PG2 Injection in 500 ml Normal Saline or 500 ml Normal Saline will be completed within 2.5~3.5 hrs. The same dose of PG2 Injection 500 mg will be repeated daily for the subsequent 2 days.
~ROUTE OF ADMINISTRATION:Continuous IV infusion via a calibrated infusion pump DURATION FOR EACH PATIENT:90 days"
16172532|NCT01603667|Drug|placebo|"STUDY DRUG DOSAGE: IV infusion of Placebo Injection 500 mg in 500 ml Normal Saline at a rate of 200 mg/hr with infusion started within 3-6 hrs of stroke onset and infusion of a total of 500 mg Placebo Injection in 500 ml Normal Saline or 500 ml Normal Saline will be completed within 2.5~3.5 hrs. The same dose of Placebo Injection 500 mg will be repeated daily for the subsequent 2 days.
~ROUTE OF ADMINISTRATION:Continuous IV infusion via a calibrated infusion pump DURATION FOR EACH PATIENT:90 days"
16172533|NCT01603654|Drug|sodium picosulphate magnesium citrate|Use of the product in colon cleansing before colonoscopy. Two sachets each containing 10 mg of sodium picosulfate, 3.5 g magnesium oxide and 12.0 g citric acid. The 2 doses are taken diluted in a glass water.
16172534|NCT01603654|Drug|low-volume PEG -ascorbic acid|THe product is used as colon cleanser before colonoscopy. It is supplied as a powder for oral use, to be reconstituted with 2 L of water and drunk as a solution. It consists of 100.0 g macrogol 3350 plus electrolytes (7.5 g sodium sulphate, 2.7 g sodium chloride, 1.0 g potassium chloride) and 4.7 g ascorbic acid.
16173185|NCT01598363|Drug|Rosuvastatin|Oral, Day 1 and Day 10
16172535|NCT01603641|Biological|Botulinum Toxin Type A|Participants received intramuscular injections of botulinum toxin Type A into the lower limb muscles and/or upper limb muscles at a minimum of 12 weeks apart for a maximum of 5 treatments.
16172536|NCT01603628|Biological|botulinum toxin Type A|Participants received intramuscular injections of botulinum toxin Type A into specified muscles of the lower limb on Day 1.
16172537|NCT01603628|Drug|Normal Saline (Placebo)|Participants received intramuscular injections of normal saline (placebo) into specified muscles of the lower limb on Day 1.
16172538|NCT01603615|Biological|Botulinum Toxin Type A|Participants received intramuscular injections of botulinum Toxin Type A in the upper and/or lower limb muscles at a minimum of 12 weeks apart for a maximum of 5 treatments.
16172539|NCT01603602|Biological|botulinum toxin Type A|Intramuscular injections of botulinum toxin Type A into specified muscles of the upper limb on Day 1.
16172540|NCT01603602|Drug|Normal Saline (Placebo)|Intramuscular injections of normal saline (placebo) into specified muscles of the upper limb on Day 1.
16172541|NCT01603589|Procedure|Coronary artery bypass grafting with the use of minimal invasive extracorporeal circulation|We use a prototype AHEPA (modular type IV) circuit comprised of the standard and a standby accessory. Components of the standard circuit include: aortic cannula, three-stage venous cannula, coated tubing, a centrifugal pump, a new-generation membrane oxygenator with integrated arterial filter, a venous air removal device, a soft coated bag and pulmonary artery as well as aortic root vent. In addition, there is a standby hard-shell reservoir in parallel to the venous line, so as to convert the closed system to an open one. The standby component is bridged to the main circuit with an afferent line which is connected just before the VARD sending blood to the hard-shell reservoir and an efferent that re-directs it back to the VARD. A cell-saver device is added to the circuit for collecting shed blood and washing red blood cells for autotransfusion.
16172542|NCT01603589|Procedure|Coronary artery bypass grafting under conventional extracorporeal circulation|A standard open CPB circuit is used, consisting of uncoated PVC tubing, a hard-shell venous reservoir, a microporous membrane oxygenator (Dideco, Mirandola, Italy) and a roller pump (Stöckert S3, Munich, Germany). The circuit contains a 40 μm arterial line blood filter (Dideco, Mirandola, Italy) and it is primed with 1500 mL of a balanced crystalloid/colloid solution (1000 mL of Ringer's solution, 200 mL of mannitol 20%, and 300 mL of hydroxyethyl starch 6%). Cardiotomy as well as sump sucker are integrated to the circuit.
16172543|NCT01603576|Device|Prototype wide view suprachoroidal retinal prosthesis|Manufacturer = Bionics Institute, Australia
16172544|NCT01603485|Drug|Lersivirine Immediate-Release (fasted)|Single 500 mg dose of Lersivirine Immediate-Release Tablets (2 x 250 mg)
16172545|NCT01603485|Drug|Lersivirine Modified-Release #1 (fasted)|Single 500 mg dose of Lersivirine Modified-Release Tablet #1
16172546|NCT01603485|Drug|Lersivirine Modified-Release #2 (fasted)|Single 500 mg dose of Lersivirine Modified-Release Tablet #2
16172547|NCT01603485|Drug|Lersivirine Modified-Release #3 (fasted)|Single 500 mg dose of Lersivirine Modified-Release Tablet #3
16172548|NCT01603485|Drug|Lersivirine Modified-Release (fed)|Single 500 mg dose of Lersivirine Modified-Release Tablet dosed with food.
16172549|NCT01603459|Drug|IncobotulinumtoxinA|"Subjects to receive up to 3 injection cycle, with the dose titrated from 400 units to up to 800 units.
~For each injection session: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400-800 units, volume 2.0 mL per 100 units; Mode of administration: intramuscular injection."
16172550|NCT01603446|Drug|L-Arginine|NOW® L-Arginine powder
16172551|NCT01603433|Device|Sapheon™ Closure System|Sapheon™ Closure System for the treatment of incompetent saphenous veins.
16172552|NCT01603420|Drug|Luteinizing hormone-releasing hormone (LHRH)|Androgen suppression therapy using luteinizing hormone-releasing hormone (LHRH) agonists such as leuprolide, goserelin, buserelin, triptorelin.
16172553|NCT01603420|Drug|Docetaxel|Docetaxel 20mg/m2 IV every 7 days x 8 weeks.
16172554|NCT01603420|Other|Conformal Radiation Therapy (RT)|1.8 Gy(RBE) (or Gy for IMRT) per fraction,five fractions per week for a total dose of 79.2 Gy (RBE) (or Gy).
16172555|NCT01603394|Drug|pregabalin|Pregabalin Capsules (150 mg - 600mg), Dose titration (4 weeks) and fixed dose (2 weeks) for a 6 week treatment period.
16172556|NCT01603381|Behavioral|Cognitive Behavioral Therapy for Insomnia (CBT-I)|Behavioral management of insomnia
16172557|NCT01603368|Dietary Supplement|Lactobacillus reuteri|Oil drops with Lactobacillus reuteri DSM 17938, 125 million bacteria=0.2 ml per day
16172558|NCT01603368|Dietary Supplement|Placebo|Oil drops without Lactobacillus reuteri
16172559|NCT01603355|Drug|Tocilizumab|"Intravenous tocilizumab:
~Patients less than 30 kg weight:10 mg per kg every 4 weeks Patients at or above 30 kg weight: 8 mg per kg every 4 weeks"
16172560|NCT01603342|Drug|clopidogrel|Following a baseline punch biopsy, all subjects will then receive oral clopidogrel (Plavix®) over a period of approximately 3 to 4 days. Once the subject has successfully had 3 days of clopidogrel dosing, a second biopsy (B1) will be performed
16172561|NCT01603342|Drug|placebo|Following a baseline punch biopsy, all subjects will then receive oral placebo over a period of approximately 3 to 4 days. Once the subject has successfully had 3 days of clopidogrel dosing, a second biopsy will be performed
16172562|NCT01603329|Other|Increasing Medication Adherence through Physician Incentives and Messaging|"There are two treatments:
~Physicians given financial incentives for improving patient medication adherence for all of the following medications: oral diabetes medication, hypertension (ACEI or ARB) medication, and cholesterol (statins) medication vs. one of the following medications: oral diabetes medication, hypertension (ACEI or ARB) medication, or cholesterol (statins) medication.
~Physicians given communication emphasizing the importance of improving adherence to all of the previous medication classes vs. one one of the previous medication classes.
~When physicians are sent a communication regarding the opportunity to receive an incentive as part of our pilot, they will also receive a single patient sheet for each patient who has less than 80% adherence. For half of the arms, the investigators will make the patient sheets a bright, non-white, color, in order to further draw the physicians' attention to that specific paper in their chart."
16172600|NCT01603069|Drug|AZD3241 300 mg BID|The following dose escalation schedule will be used for 300 mg BID: 100 mg BID from Day 1 through Day 7. On Day 8, the patients will start maintenance treatment of 300 mg BID for the duration of the treatment period.
16172701|NCT01602341|Drug|AN2728 Topical Ointment, 0.5% QD|AN2728 Topical Ointment, 0.5% QD
16172702|NCT01602341|Drug|AN2728 Topical Ointment, 2% BID|AN2728 Topical Ointment, 2% BID
16172563|NCT01603316|Behavioral|surveys|Each survey will take about 45 minutes.Surveys will include questions on medical treatment, health insurance, work-related information, overall health and well being, eating habits, and satisfaction/use of the food program provided. 3 and 6-month follow-up. All participants will be asked to complete the study contact form. Need Assessment surveys will be administered via telephone or in person. The content of the needs assessment questionnaire has been informed by themes generated through IHCD's ongoing research and community outreach and service activities with the cancer patient population at our participating institutions. The survey will ask participants about the impact on their cancer care and their socioeconomic needs of the COVID-19 crisis.
16172564|NCT01603316|Behavioral|Focus groups|Prior to conducting the updated RCT design with the expanded cohort, we will conduct 4-6 focus groups (to saturation) with underserved breast cancer patients to optimally tailor the written materials, via mail, MSK Secure email, or in person and nutrition education sessions.
16172565|NCT01603303|Behavioral|Questionnaires|Completion of 8 or 9 brief questionnaires at start of study and 6 and 12 months afterwards. Questionnaires should take about 45 to 50 minutes to fill out each time.
16172566|NCT01603303|Other|Education Materials|Participants receive written handout about ways to keep bones stronger during treatment with Aromatase Inhibitors (AIs) and ways to prevent AI side effects such as muscle aches, stiffness, sexual problems, and hot flashes.
16172567|NCT01603303|Other|Luvena|Use vaginally 2 or 3 times a week.
16172568|NCT01603303|Other|Hyalo-Gyn|Use vaginally 2 - 3 times a week.
16172569|NCT01603303|Other|Vaginal Lubricant|Water-based vaginal lubricant used during sexual activity.
16172570|NCT01603303|Behavioral|Interactive Internet-Based Website|Participants use an interactive, internet-based website called Tendrils: Sexual Renewal after Cancer before, during and after treatment with AIs.
16172571|NCT01603303|Behavioral|Telephone Counseling.|Telephone counseling for up to 30 minutes in weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. The counselor will follow a manualized program and some sessions will be recorded.
16172572|NCT01603277|Biological|Anti-GM-CSF Monoclonal Antibody 400mg|Anti-GM-CSF Monoclonal Antibody 400mg
16172573|NCT01603277|Other|Placebo|Normal Saline
16172574|NCT01603264|Biological|PF-05280014|Concentrate for solution for infusion, sterile vial 150 mg, single-dose 6 mg/kg administered as 90-minute infusion on day 1
16172575|NCT01603264|Biological|Herceptin|Concentrate for solution for infusion, sterile vial 150 mg, single-dose 6 mg/kg administered as 90-minute infusion on day 1
16172576|NCT01603264|Biological|Herceptin|Concentrate for solution for infusion, sterile vial 440 mg, single-dose 6 mg/kg administered as 90-minute infusion on day 1
16172577|NCT01603251|Drug|Artemether-lumefantrine combination|Artemether-Lumefantrine (AL)combination; a placebo is given together with the first and fifth dose of AL
16172578|NCT01603251|Drug|Artemether-lumefantrine combination + single dose Ivermectin|Artemether-lumefantrine (AL) combination + Ivermectin (200ug/kg) given once together with the first dose of AL. A placebo is given together with the fifth dose of AL.
16172579|NCT01603251|Drug|Artemether-lumefantrine combination + repeated dose Ivermectin|Artemether-lumefantrine (AL) combination + Ivermectin (200ug/kg) given together with the first and fifth dose of AL.
16172580|NCT01603238|Drug|[14C]-LC15-0444|A single oral administration of [14C]-LC15-0444 50 mg, containing 4.9 MBq [14C]. Subjects in the fasted state will receive the drug as a capsule, with 240 ml of water.
16172582|NCT01603212|Drug|Vemurafenib|"Phase I Starting dose: 720 mg by mouth twice a day for a 21 day cycle.
~Phase II Starting dose: Maximum tolerated dose (MTD) from Phase I."
16172583|NCT01603212|Drug|IL-2|"Phase I Starting Dose: 7 million IU/m2 by vein on Days 2 - 5 of a 21 day cycle.
~Phase II Starting Dose: Maximum tolerated dose (MTD) from Phase I."
16172584|NCT01603212|Drug|Interferon Alpha-2b|5 million U/m2 subcutaneously on Days 1 - 5 of a 21 day cycle.
16172585|NCT01603199|Dietary Supplement|High protein high fiber diet|A personalized high protein high fiber dietary plan will be provided to each participant from both groups. Each participant will receive nutritional counseling once a month during six months.
16172586|NCT01603186|Drug|Quetiapine Fumarate Tablets 25 mg|25 mg tablet once a day
16172587|NCT01603186|Drug|Quetiapine Fumarate|25 mg tablet once a day
16172588|NCT01603173|Drug|Quetiapine Fumarate Tablets 25 mg|25 mg tablet once a day
16172589|NCT01603173|Drug|Quetiapine Fumarate|25 mg tablet once a day
16172590|NCT01603160|Behavioral|Quality Improvement|"There are no interventions for the individual patient. The changes in processes developed by the quality improvement team will be made for all adults with sickle cell disease, not just adults who consent to interviews.
~A proactive risk assessment methodology, Failure Modes, Effects, and Criticality Analysis (FMECA), will be used in two EDs to identify the vulnerabilities, risks, and weak points (failures) in the systems and processes involved in four key decisions of the ED-SCANS. Based on the aggregated results of the FMECA's, generalizable quality improvement interventions (QII's) will be developed and implemented with the purpose of changing the way emergency care for adults with SCD is delivered and organized."
16172591|NCT01603147|Biological|normal saline|saline 225 ml
16172592|NCT01603147|Biological|ch-mAb7f9|The single doses to be administered in each cohort are 0.2, 0.6, 2, 6, and 20 mg/kg, respectively. Volume to be administered 225 ml
16172593|NCT01603134|Drug|Allopurinol|300 mg tablet once a day
16172594|NCT01603134|Drug|Allopurinol|300 mg tablet once a day
16172595|NCT01603121|Drug|Lisofylline|Lisofylline single dose of 9 mg/kg continuous intravenous infusion over a 10 hour period, and lisofylline single dose of 12 mg/kg continuous subcutaneous infusion over a 10 hour period during the alternate period 1 week apart.
16172596|NCT01603108|Drug|Rifaximin|Rifaximin will be initiated post-LT, once the subject is able to tolerate oral medications/diet. Rifaximin will be dosed at 550mg twice daily for 90 days (+/- 10 days) post-LT.
16172597|NCT01603108|Drug|Placebo|Rifaximin placebo will be initiated post LT, once the subject is able to tolerate oral medications/diet. Rifaximin placebo dosed at 550 mg twice daily for 90 days (+/10 days) post LT.
16172598|NCT01603082|Drug|Ticagrelor|180 mg loading dose
16172599|NCT01603082|Drug|Clopidogrel|600 mg loading dose
16173694|NCT01594762|Drug|Topical placebo cream|14 days of treatment
16172601|NCT01603069|Drug|AZD3241 600 mg BID|The following dose escalation schedule will be used for 600 mg BID: 100 mg BID from Day 1 through Day 7 and 300 mg BID from Day 8 through Day 14. On Day 15, the patients will start maintenance treatment of 600 mg BID for the duration of the treatment period.
16172602|NCT01603069|Drug|Placebo|Placebo to AZD3241 BID
16172603|NCT01603056|Biological|Pangramin SLIT HDM mix.|Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
16172604|NCT01603056|Biological|Placebo|Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
16172605|NCT01603043|Drug|Al-78898A|0.400 milligrams (mg) per 50 microliters (μL) administered as an intravitreal injection
16172606|NCT01603043|Drug|Sham injection|Mock injection administered as an empty hub without needle
16172607|NCT01603030|Drug|moxifloxacin 0,5% + prednisolone 1%|1 gtt, 4x/day, 15 days
16172608|NCT01603030|Drug|moxifloxacin/prednisolone combination|1 gtt, 4x/day, 15 days
16172609|NCT01603017|Device|MRI therapy|5 treatments with magnetic field delivered to knee (n=50)
16172610|NCT01603017|Device|MRI therapy (off)|5 treatment where MRI therapy machine was switched off (both patient and therapist blinded to this by use of electronic 'prescription cards'). (n=50)
16172611|NCT01603004|Other|MRI|Patients will be treated with either sunitinib, everolimus, or traditional chemotherapy according to standard of care. Follow-up with imaging (either MRI or CT) will be performed approximately every 3 months. Unidimensional tumor measurement on standard CT and MRI sequences will be performed, according to guidelines from RECIST v1.1, which will be used to assess for progression of disease. Patients will be followed for up to 5 years. Upon evidence of disease progression, patients will be asked to undergo a post-treatment biopsy. If medically possible and safe, they will stay on the drug until the time of biopsy.
16172612|NCT01602991|Procedure|clinic-based nasopharyngoendoscopy|The study intervention is an in-office transnasal esophagoscopy. It is done in clinic, immediately after deciding the patient requires investigation of their upper gastrointestinal tract and the patient signs consent. The nasopharynx and oral pharynx is topically anesthetized. Since flexible scope is much thinner than a standard endoscopy, there is no requirement for intravenous sedation and thus, no requirement for specialized monitoring, nursing or recovery units. The procedure takes approximately 10 minutes. This study will be using the E.G. Scan II System.
16172613|NCT01602991|Procedure|Standard Endoscopy|The control procedure is standard endoscopy. Endoscopy will be performed as per standard clinic practice. It is typically scheduled within 2 weeks of seeing the patient in clinic. The patient will be required to fast for 6 hours prior to the procedure. In most cases, patients will require intravenous sedation. If sedation is used, the patient will be required to take the day off work and have someone drive them home. This is the standard treatment for patients who present with upper gastrointestinal symptoms post-bariatric surgery. Patients who choose not to participate in this study will still undergo endoscopy as per standard clinical practice.
16172614|NCT01602965|Procedure|Counseling Monthly Phone Calls|the dietician will call the patient at home, and invite them to answer 11 open questions.The questionnaire collects information about weight loss, behaviors that need to be changed, problem-solving as to how to make the changes and physical activity levels.
16172615|NCT01602965|Procedure|Self Help Informative Booklet|Self help informative booklet includes information on how to manage healthy weight, how to lose weight, physical activity and a simplified and abbreviated version of the main behavioural strategies
16172616|NCT01602952|Drug|Radotinib|50mg, 100mg or 200mg Capsule BID
16172617|NCT01602939|Drug|Cladribine and pegylated interpheron alpha-2a|"Cladribine (0.07 mg/Kg/day) s.c for 5 consecutive days each month for a total of 6 months.Cladribine daily doses could be increased up to 0.14 mg/Kg in the fourth, fifth and sixth cycles of therapy if no objetive response is achieved after the third cycle.
~Pegylated Interpheron alpha-2a (1 mcgr/Kg) s.c weekly for a total of 6 months."
16172618|NCT01602926|Procedure|conventional surgical technique - Chevron-type distal metatarsal osteotomy|The conventional surgical technique is a Chevron-type distal metatarsal osteotomy, which is performed through a dorsomedial incision approximately 7 cm long. And osteotomy of the distal portion of the first metatarsal is made. The capital or distal fragment of the metatarsal is mobilized and displaced laterally an adequate amount to correct the hallux valgus deformity. The capital or distal fragment is stabilized in corrected position with screws. The internal fixation screws used in the conventional surgical technique do not require removal.
16172619|NCT01602926|Procedure|minimally invasive surgical technique|The minimally invasive surgical technique is a transverse subcapital distal metatarsal osteotomy, which is performed through a direct medial incision approximately 1 cm long. The osteotomy of the distal portion of the first metatarsal is made using fluoroscopic image guidance. The capital or distal fragment of the metatarsal is mobilized and displaced laterally an adequate amount to correct the hallux valgus deformity. A 2.0 mm Kirschner wire is placed percutaneously in a position medial to the proximal phalanx, and advanced proximally using fluoroscopic guidance until the proximal end of the wire is located in a stable position within the medullary cavity of the first metatarsal (see figures) .The distal end of the Kirschner wire is left outside the skin where it is cut to length and covered. The Kirschner wire is removed after six weeks.
16172620|NCT01602926|Procedure|minimally invasive surgical technique|The minimally invasive surgical technique is a transverse subcapital distal metatarsal osteotomy, which is performed through a direct medial incision approximately 1 cm long. The osteotomy of the distal portion of the first metatarsal is made using fluoroscopic image guidance. The capital or distal fragment of the metatarsal is mobilized and displaced laterally an adequate amount to correct the hallux valgus deformity.
16172621|NCT01602913|Drug|Pravastatin alone|Pravastatin is a member of the drug class of statins, also known as HMG-CoA reductase inhibitors, and is known to reduce the amount of cholesterol and other fatty substances in the blood. In addition, pravastatin is indicated to reduce the risk of myocardial infarction, revascularization and cardiovascular mortality in hypercholesterolemic patients who do not have clinically apparent coronary heart disease.
16172622|NCT01602913|Drug|Paroxetine alone|Paroxetine is an orally administered selective serotonin reuptake inhibitor (SSRI) for the treatment of depression
16172647|NCT01602705|Other|Feedback of Performance|Usual care (educational newsletter and support for searching) plus quarterly feedback of practice rates of high risk prescribing compared to a benchmark of the upper quartile of all practices in the year before
16172703|NCT01602341|Drug|AN2728 Topical Ointment, 0.5% BID|AN2728 Topical Ointment, 0.5% BID
16172623|NCT01602913|Drug|Pravastatin and paroxetine combined|Pravastatin is a member of the drug class of statins, also known as HMG-CoA reductase inhibitors, and is known to reduce the amount of cholesterol and other fatty substances in the blood. In addition, pravastatin is indicated to reduce the risk of myocardial infarction, revascularization and cardiovascular mortality in hypercholesterolemic patients who do not have clinically apparent coronary heart disease. Paroxetine is an orally administered selective serotonin reuptake inhibitor (SSRI) for the treatment of depression
16172624|NCT01602900|Drug|GSK356278|Investigational Medicinal Product
16172625|NCT01602900|Drug|Rolipram|Challenge Agent
16172626|NCT01602887|Drug|PD-0332991|isethionate hard capsule, 125 mg, single dose
16172627|NCT01602887|Drug|PD-0332991|"freebase hard capsule with a small particle size, 125 mg, single dose"
16172628|NCT01602887|Drug|PD-0332991|"freebase hard capsule with a large particle size, 125 mg, single dose"
16172629|NCT01602887|Drug|PD-0332991|oral solution, 50 mg, single dose
16172630|NCT01602874|Drug|Tigecycline|"Subject with cIAI:
~Dosing information for subjects 8 to 11 years old is currently under investigation and will be determined later. Subjects 12 to 17 years old will receive tigecycline 50 mg IV every 12 hours, metronidazole placebo IV will be administered every 8 hours. In addition, at the discretion of the investigator, an aminoglycoside placebo IV may also be administered."
16172631|NCT01602874|Drug|Tigecycline|"Subject with CAP:
~IV therapy period: Dosing information for subjects 8 to 11 years old is currently under investigation and will be determined later. Subjects 12 to 17 years old will receive tigecycline 50 mg IV every 12h. At the discretion of the investigator oral clarithromycin placebo may be given every 12h.
~Oral therapy period: If oral switch criteria are met, on or after Day 4 amoxicillin/clavulanate may be prescribed (40 mg/kg per day divided into 3 equal doses, maximum of 500 mg/dose to subjects weighing less than 40 kg and 500 mg every 8h to subjects weighing 40 kg or greater). In addition, if oral clarithromycin or placebo had been given during the IV period, oral clarithromycin may be given every 12h (7.5 mg/kg, maximum dose 500 mg for subjects 8 to 11 years old, 500 mg for subjects 12 to 17 years old)."
16172632|NCT01602874|Drug|cIAI: Ceftriaxone with metronidazole, plus if applicable aminoglycoside|"Subject with cIAI:
~Subjects will receive ceftriaxone 35 mg/kg (maximum of 1 g/dose) IV every 12 hours, metronidazole 10 mg/kg (maximum of 1 g/dose) IV will be administered every 8 hours.
~In addition, at the discretion of the investigator, an aminoglycoside IV (adjusted dose if necessary) may also be given."
16172633|NCT01602874|Drug|CAP: Ceftriaxone, plus if applicable oral clarithromycin|"Subject with CAP:
~IV therapy period: Subjects will receive ceftriaxone 35 mg/kg (maximum of 1 g/dose) IV every 12h. At the discretion of the investigator, oral clarithromycin may be given every 12h (7.5 mg/kg, maximum dose 500 mg for subjects 8 to 11 years old, 500 mg for subjects 12 to 17 years old).
~Oral therapy period: If oral switch criteria are met, on or after Day 4 amoxicillin/clavulanate may be prescribed (40 mg/kg per day divided into 3 equal doses, maximum of 500 mg/dose to subjects weighing less than 40 kg and 500 mg every 8h to subjects weighing 40 kg or greater). In addition, if oral clarithromycin or placebo had been given during the IV period, oral clarithromycin may be given every 12h (7.5 mg/kg, maximum dose 500 mg for subjects 8 to 11 years old, 500 mg for subjects 12 to 17 years old)."
16172634|NCT01602861|Drug|Spironolactone|"One tablet per day (25 mg Spironolactone/placebo) for the first three months. Subsequently dosage is increased to two tablets per day (50 mg Spironolactone/placebo) for the rest of the study.
~In case of hyperkaliemia (>5,5 mmol/L) or intolerable side effects dosage will be reduced to one tablet per day (25 mg Spironolactone/placebo)."
16172635|NCT01602861|Drug|placebo|
16172636|NCT01602848|Other|Intensive care management and coordination|Care Management Teams comprised of social workers, community based care managers, and dedicated clinicians work to meet patients' needs in both the health care setting and the community. The CIDP model incorporates motivational interviewing, harm reduction, access to housing through our community partners utilizing a Housing First approach, and provides cellular phones for patients when needed, to better enable regular communication with program staff.
16172637|NCT01602822|Drug|3 drug regimen: Tenofovir DF and Emtricitabine; Ritonavir-boosted Atazanavir|TDF 300mg and FTC 200mg fixed-dose combination tablet (TDF/FTC) once daily, and atazanavir, one 300mg tablet and one 100 mg ritonavir given once daily
16172638|NCT01602822|Drug|Ritonavir, Atazanavir, Truvada|
16172639|NCT01602796|Behavioral|School intervention|The ITACA intervention is a cognitive and social-influences approach to prevent tobacco consumption. The intervention is integrated in the curricula of the school, also schools are reinforced to follow a smoke-free school and strictly follow legislation about smoking in schools. The community component include annual meeting with adolescents parents and parents and teachers intensive group for smoking cessation.
16172640|NCT01602783|Other|11C Acetate Imaging|Single scan
16172641|NCT01602770|Drug|EV/DNG (Qlaira, BAY86-5027)|Qlaira is taken daily continously with no pause between cycles in a four-phasic dose regimen, making up a treatment of up to 28 days. The first two tablets contain 3 mg Estradiol Valerate (E2V). The next five tablets include 2 mg E2V and 2 mg Dienogest (DNG) followed by 17 tablets with 2 mg E2V and 3 mg DNG. Finally, there are two tablets with 1 mg E2V and two placebo tablets.
16172642|NCT01602757|Drug|Synera|"Subjects received 4 Synera® patches for 2 hours in Session 1 and 4 patches for 12 hours in Session 4. During Study Session 2, subjects were randomly assigned to 4-hour applications of either 4 Synera® patches or 4 lidocaine/tetracaine patches without heat (no heat patches) and were crossed over during Study Session 3."
16172643|NCT01602744|Other|STOPP/START screening tools for medication intervention|In the intervention arm the investigator will use the screening tools STOPP/START to screen the medications.
16172644|NCT01602731|Device|Automated Medication Dispensing Device|All patients had a pre-filled medication dispensing machine set up at their homes, filled by home health nurses once a month. Safety phone call was made by the AMDD company if doses were missed.
16172645|NCT01602718|Other|exercise training|Pilot study of independent home exercise training (walking or cycling exercise plus low level resistance exercise) for 3 months. Patients will be given specific recommendations for type, frequency, duration and progression of their program and will be contacted weekly by study staff to assess progress and evaluation for any problems. This is a 3 month exercise training intervention in 15 subjects (and 15 no-exercise controls).
16172646|NCT01602705|Other|Usual care|Practices in the usual care arm receive a one-off educational newsletter and support for searching for patients in their electronic health record in the form of downloadable searches
16172648|NCT01602705|Other|Feedback of Performance + Health Psychology Informed Intervention|Usual care (educational newsletter + support for searching) plus quarterly feedback plus health psychology informed intervention (persuasive communication and action planning) embedded in feedback
16172649|NCT01602692|Drug|Tumescent solution with dilute lidocaine and epinephrine|Tumescent Solution containing both dilute lidocaine (0.05%) and dilute epinephrine (1:1,000,000)
16172650|NCT01602692|Drug|Tumescent Solution with dilute epinephrine|Tumescent Solution containing dilute epinephrine (1:1,000,000) only
16172651|NCT01602679|Drug|oral micronized progesterone suspension|oral micronized progesterone (100 mg p.o.) suspension
16172652|NCT01602679|Drug|Placebo|Placebo contains only inert ingredients and is not expected to exert any direct physiological effects
16172653|NCT01602666|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo 3D-CRT
16172654|NCT01602666|Drug|Carboplatin|Given IV
16172655|NCT01602666|Drug|Etoposide|Given IV
16172656|NCT01602666|Drug|Ifosfamide|Given IV
16172657|NCT01602666|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16172658|NCT01602653|Device|Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK|an energy level of 0.20mJ/mm2, 2400 pulses once a week for 4 weeks.
16172659|NCT01602653|Device|Extracorporeal shock wave therapy STORZ MEDICAL Modulith SLK|an energy level of 0.10mJ/mm2, 2400 pulses once a week for 4 weeks.
16172660|NCT01602640|Drug|Morphine infusion|Conventional dose
16172661|NCT01602640|Drug|Fentanyl and Midazolam infusion|Conventional dose
16172662|NCT01602627|Drug|Hsp90 inhibitor AUY922|Given IV
16172663|NCT01602627|Other|pharmacological study|Correlative studies
16172664|NCT01602627|Other|laboratory biomarker analysis|Correlative studies
16172665|NCT01602601|Drug|Idursulfase|recombinant version of IDS produced from human fibroblast. idursulfase is approved for every week (EW) intravenous (IV) administration.
16172666|NCT01602601|Drug|GSK2788723|GSK2788723 is being developed by JCR and GSK for the treatment of Hunter syndrome
16172667|NCT01602588|Drug|Hydroxychloroquine|200mg bd from 14 days post surgery until clinical or radiological progression
16172668|NCT01602588|Radiation|Radiotherapy|Short Course radiotherapy
16172669|NCT01602575|Behavioral|Mindfulness based Stress Reduction Training (MBSR)|8 (2 hr) classes weekly of MBSR and required homework of MBSR practice approximately 30 minutes per day.
16172670|NCT01602562|Drug|VACV tablets (Adults or pediatrics) or granules (pediatrics)|A white to slightly yellowish white film coated tablet contains 556 mg of valaciclovir hydrochloride (500 mg of valaciclovir)). VACV granules have no or slightly specific odor.
16172671|NCT01602549|Drug|GSK962040 (25 mg tablet)|25 mg tablet
16172672|NCT01602549|Drug|Placebo|matching placebo tablet
16172673|NCT01602536|Behavioral|smoking cessation aides|All participants will receive 8 weeks of free nicotine patches, referral to the NCI's online Smokefree.gov Quit Guide, and instruction to set a quit date within 8 days of study start.
16172674|NCT01602536|Behavioral|Twitter|Twitter quit-smoking group
16172675|NCT01602523|Drug|Budesonide/formoterol|Budesonide/formoterol Spray inhaler 160/4.5 mcg daily 28 days
16172676|NCT01602523|Drug|Placebo|Placebo inhaler once daily 28 days
16172677|NCT01602510|Drug|Lamotrigine|in the double blind phase, lamotrigine 200mg/day will be used among half of eligible subjects after randomization
16172678|NCT01602510|Drug|Placebo|Placebo
16172679|NCT01602497|Device|rTMS|Patients undergone 10 session of high-frequency rTMS therapy over their left DLPFC
16172680|NCT01602497|Device|sham rTMS|Patients will undergo ten session of sham rTMS.
16172681|NCT01602484|Device|Pre-prepared Splint Pack composed by Medline|Applying splint by using pre-prepared splint pack
16172682|NCT01602484|Device|Bulk splint supplies|Applying splint by using the bulk splint supplies
16172683|NCT01602471|Drug|[F-18]RDG-K5|Approximately fifteen (15) patients with carotid artery stenosis > 69% will undergo an endarterectomy and will be imaged under PET/CT with [F-18]RGD-K5
16172684|NCT01602458|Procedure|Silicone Only Therapy (SOT)|SOT group will be instructed to wear the silicone for 23 hours/day, removing only for bathing. A new piece of Mepiform™ silicone should be replaced weekly and applied to clean, dry skin. Compression free medical tape will be used to secure the silicone in place. Patients will be provided with 6 months of topical silicone therapy. If optimal results are achieved prior to 6 months of therapy, the treatment will be discontinued. Patients will also be provided with Scar Management for Skin Grafts Homecare Instructions: Silicone.
16172685|NCT01602458|Procedure|Silicone Pressure Garment Therapy (SPGT)|"SPGT group will be instructed to use the Mepiform™ silicone only for 2 weeks during the interim before final fitting with the custom compression garment. A new piece of Mepiform™ silicone should be replaced weekly and applied to clean, dry skin. The patients will be instructed to wear the silicone for 23 hours/day, removing only for bathing.
~The patient will continue to use the Mepiform™ silicone under the compression garment for the entire length of the study. The garment will be replaced after 3 months of wear, in order to ensure that optimal pressure and silicone management is applied to the area. Patients will be provided with Scar Management for Skin Grafts Homecare Instructions: Silicone and Compression Garment."
16172686|NCT01602419|Other|Patients using Wilate as standard of care|Patients with von Willebrand Disease using Wilate for a period of 2 years.
16172687|NCT01602406|Drug|LJM716|LJM716
16172688|NCT01602406|Drug|Trastuzumab|Trastuzumab
16172689|NCT01602393|Drug|CHF 5074 1x|oral tablet, 1x, once a day in the morning for 48 weeks
16172690|NCT01602393|Drug|CHF 5074 2x|oral tablet, 2x, once a day in the morning for 48 weeks
16172691|NCT01602393|Drug|CHF 5074 3x|oral tablet, 3x, once a day in the morning for 48 weeks
16172692|NCT01602380|Drug|faslodex 500mg|2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter
16172693|NCT01602380|Drug|arimidex 1mg|oral tablet 1 daily
16172694|NCT01602380|Drug|faslodex dummy|2 x intramuscular injections at day 1, 14, 28 and every 28 days thereafter
16172695|NCT01602380|Drug|arimidex dummy|oral tablet 1 daily
16172696|NCT01602367|Drug|BMS-823778|Capsules, Oral, 2 mg, Once daily, 12 weeks
16172697|NCT01602367|Drug|BMS-823778|Capsules, Oral, 6 mg, Once daily, 12 weeks
16172698|NCT01602367|Drug|BMS-823778|Capsules, Oral, 15 mg, Once daily, 12 weeks
16173695|NCT01594762|Other|Standard wound care|14 days of treatment
16172704|NCT01602328|Biological|AC607|AC607 will be a single administration at a target dose of 2 x 10E6 hMSC/kg body weight
16172705|NCT01602328|Biological|Vehicle Only|The dose will be calculated and recorded in the same way as for AC607.
16172706|NCT01602315|Drug|BYL719 as film-coated (FC) whole tablets|Oral alpha-specific PI3K inhibitor
16172707|NCT01602315|Drug|BYL719 as dispersible tablets (DT)|New formulation of the oral alpha-specific PI3K inhibitor
16172708|NCT01602315|Biological|cetuximab|Recombinant chimeric monoclonal antibody driven against EGFR
16172709|NCT01602315|Drug|BYL719 drink suspension|Oral alpha-specific PI3K inhibitor
16172710|NCT01602302|Drug|bDMARD withdrawal (etanercept, adalimumab, infliximab, certolizumab, golimumab, tozilizumab, abatacept)|bDMARDS (etanercept, adalimumab, infliximab, certolizumab, golimumab, tocilizumab, abatacept) will be discontinued after baseline visit in all participants
16172711|NCT01602289|Biological|LY2875358|Administered IV
16172712|NCT01602289|Drug|Erlotinib|Administered orally
16172713|NCT01602289|Drug|Gefitinib|Administered orally
16172714|NCT01602276|Procedure|Transcranial Direct Current Stimulation (tDCS)|Anodal, Cathodal or Sham tDCS
16172715|NCT01602263|Procedure|Transcranial Direct Current Stimulation (tDCS)|Anodal, Cathodal or Sham tDCS.
16172716|NCT01602250|Drug|placebo|Levobupivacaine 8 mg/min ropivacaine 8 mg/min
16172717|NCT01602250|Drug|Intralipid®|Levobupivacaine 8 mg/min ropivacaine 8 mg/min Intralipid® 120 ml in one min
16172718|NCT01602224|Drug|Placebo|Administered IV
16172719|NCT01602224|Drug|Dexamethasone|Administered orally
16172720|NCT01602224|Drug|Bortezomib|Administered SQ
16172721|NCT01602224|Biological|Tabalumab|Administered IV
16172722|NCT01602211|Other|Internet-Based Intervention|Receive full access to INSPIRE
16172723|NCT01602211|Other|Internet-Based Intervention|Receive access to an annotated list of existing resources for transplant and cancer survivors and delayed access to INSPIRE site
16172724|NCT01602211|Other|Medical Chart Review|Ancillary studies
16172725|NCT01602211|Other|Quality-of-Life Assessment|Ancillary studies
16172726|NCT01602211|Other|Questionnaire Administration|Ancillary studies
16172727|NCT01602198|Drug|Exelon [rivastigmine] transdermal patch|Exelon patch 1/day for six months
16172728|NCT01602198|Drug|Placebo transdermal patch|Placebo transdermal patch 1/day for 6 months
16172729|NCT01602185|Drug|Dextromethorphan (drug used like antitussive)|The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity
16172730|NCT01602185|Drug|Memantine (drug used in Alzheimer's disease)|The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity
16172731|NCT01602185|Drug|Placebo (lactose)|The aim of this study is to evaluate if memantine or dextromethorphan gave in relay to ketamine maintains or induces a decrease of pain intensity
16172732|NCT01602172|Behavioral|Brief Alcohol Intervention|3 part intervention: Part I is 15-minute multi-component motivational discussion in hospital which includes personalized risk feedback, advice to abstain or reduce consumption, and the negotiation of an individual change plan. Part II is 15-minute follow-up in hospital to reinforce Part I. Part III is 15-minute follow-up telephone call at 2 weeks to reinforce Part I.
16172733|NCT01602172|Other|Lifestyle brochures|Set of educational brochures/brochures which contain information and tips for healthy lifestyle behaviors such as alcohol and tobacco use, weight management, and physical activity to discuss with the Research Assistant. Approximately two weeks later, the Research Assistant will call patients in this condition at home for a 5-15 minute session to review the brochures and discuss any questions that s(he) may have.
16172734|NCT01602159|Procedure|Open Bypass Surgery|Open Bypass Surgery with Autogenous vein or PTFE Graft
16172735|NCT01602159|Procedure|Angioplasty and Stenting|Angioplasty and Stenting of the superficial Femoral artery with Nitinol stent (Life Stent flexStar Stent System by Bard Inc. Tempe AZ).
16172736|NCT01602146|Other|ultramarathon running|"blood samples before and after ultramarathon
~urinary samples before and after ultramarathon
~voluntary ant electrically muscular forces measuring before and after ultramarathon
~Broadband ultrasound Attenuation before and after ultramarathon"
16172737|NCT01602133|Procedure|peripheral venous puncture|Ultrasound imaging of the arm is performed. If a suitable vein is identified, a percutaneous puncture is performed under ultrasound guidance. Then, an intravenous catheter is inserted according Seldinger method.
16172738|NCT01602120|Drug|Lampalizumab|Lampalizumab 10 mg ITV injections as per the schedule specified in respective arms.
16172739|NCT01602107|Other|Pelvic Floor muscle strengthening exercises|Participants will attend regular physical therapy visits (weekly X 2 weeks, bi-weekly X 4 weeks, and continuing monthly) until the time of their surgery. they will then see the physical therapist for assessment, exercise and advice at 2 and 4 weeks after their surgery. During physical therapy visits, patients will receive two sessions of biofeedback training, and at each visit will work on strength and motor control exercises for their pelvic floor muscles.
16172740|NCT01602081|Device|reinforce soft tissue|reinforce soft tissue
16172741|NCT01602068|Drug|Dexamethasone Phosphate Ophthalmic|Transcleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis)
16172742|NCT01602068|Drug|100 mM Sodium Citrate Buffer|Transcleral iontophoresis delivery of 100 mM sodium citrate buffer solution
16172743|NCT01602055|Drug|Azithromycin|Single dose 500 mg of film coated tablet
16172744|NCT01602055|Drug|Azithromycin|Single dose 500 mg of film coated tablet
16172745|NCT01602029|Drug|Ondansetron|ondansetron added to TAU Ondansetron will be administered in 8mg once daily dose
16172746|NCT01602029|Drug|Simvastatin|Simvastatin added to TAU Simvastatin 20mg taken as once daily dose
16172747|NCT01602029|Drug|Placebo|Placebo added to TAU
16172748|NCT01602029|Drug|Odansetron plus simvastatin|Ondansetron will be administered in 8mg once daily dose and Simvastatin 20mg taken as once daily dose
16172749|NCT01602016|Drug|Folinic Acid and placebo|Capsules of folinic acid and placebo will be administered in 1mg/kg/day in two divided doses (0.5mg/kg/dose; 25mg/day maximum) for two weeks followed by 2 mg/kg/day with a maximum dose of 50mg/day provided the lower dose is well tolerated for 10 weeks.
16172950|NCT01600443|Device|LoFric|Three catheterizations at least two hours apart using LoFric Primo 40 cm CH14.
16172750|NCT01602016|Drug|Folinic Acid|capsules of folinic acis will be provided. The target dose will be 1mg/kg/day in two divided doses (0.5mg/kg/dose; 25mg/day maximum) for two weeks followed by 2 mg/kg/day with a maximum dose of 50mg/day provided the lower dose is well tolerated, for 10 weeks.
16172751|NCT01602003|Drug|LC15-0444 25mg bid|Each patient was given 3 different bottles of study drugs that comprised of two morning bottles and one evening bottles. Each morning bottle contained LC15-0444 25 mg or 50 mg or Sitagliptin 100mg(depending on the randomized group) or its matching placebo while the evening bottle contained LC15-0444 25 mg or its matching placebo. Patient was instructed to take 1 tablet from each bottle at regular times in the morning and evening every day during the 24-week double-blind treatment period.
16172752|NCT01602003|Drug|LC15-0444 50mg qd|Each patient was given 3 different bottles of study drugs that comprised of two morning bottles and one evening bottles. Each morning bottle contained LC15-0444 25 mg or 50 mg or Sitagliptin 100mg(depending on the randomized group) or its matching placebo while the evening bottle contained LC15-0444 25 mg or its matching placebo. Patient was instructed to take 1 tablet from each bottle at regular times in the morning and evening every day during the 24-week double-blind treatment period.
16172753|NCT01602003|Drug|Sitagliptin 100mg qd|Each patient was given 3 different bottles of study drugs that comprised of two morning bottles and one evening bottles. Each morning bottle contained LC15-0444 25 mg or 50 mg or Sitagliptin 100mg(depending on the randomized group) or its matching placebo while the evening bottle contained LC15-0444 25 mg or its matching placebo. Patient was instructed to take 1 tablet from each bottle at regular times in the morning and evening every day during the 24-week double-blind treatment period.
16172754|NCT01601990|Drug|Placebo group(once daily)|eligible patients were randomized to LC15-0444 50mg or placebo groups and received the assigned treatment for 24 weeks.
16172755|NCT01601990|Drug|LC15-0444 50mg qd|eligible patients were randomized to LC15-0444 50mg or placebo groups and received the assigned treatment for 24 weeks
16172756|NCT01601977|Device|AVAPS-AE|Novel ventilation mode (Omnilab - AVAPS AE algorithm)
16172757|NCT01601977|Device|Usual care|Non-invasive ventilation with standard ventilator
16172758|NCT01601951|Other|Procedural, Bone Marrow concentrate injection|This is strictly data collection and outcomes based. The procedure is not part of this study
16172759|NCT01601938|Dietary Supplement|selenium replacement|Selenium 500 mcg (10 mL) mixed to 230 mL of normal saline will be infused continuously per day (10 mL/hour). Study drugs will be infused for 7 days.
16172760|NCT01601938|Dietary Supplement|Placebo|placebo (10 mL) mixed to 230 mL of normal saline will be infused continuously per day (10 mL/hour). Study drugs will be infused for 7 days.
16172761|NCT01601925|Other|supine extended position of the neck|we measure the distances from cricoid cartilage to C6 or C7 transverse process in supine neutral and extended position of the neck
16172762|NCT01601912|Drug|Atomoxetine|40 mg, 1 application
16172763|NCT01601912|Drug|Citalopram|20 mg, 1 application
16172764|NCT01601899|Drug|Stavudine|30 mg po BD if wt < 60kg, or 40 mg po BD if wt > 60kg
16172765|NCT01601899|Drug|Stavudine|20 mg po BD if wt < 60kg, or 30 mg po BD if wt > 60kg
16172766|NCT01601899|Drug|Tenofovir|300 mg po QD
16172767|NCT01601873|Device|PROPATEN|Heparin-bonded graft implantation for hemodialysis vascular access
16172768|NCT01601873|Device|Standard Graft|non-heparin bonded conventional hemodialysis vascular access graft
16172769|NCT01601860|Other|Use of non-pharmacological|"Other: Non-pharmacological resources
~A sequence of non-pharmacological resources were applied to the patient by the researcher according to uterine cervical dilation, as follows:
~Walking (with cervical dilation between 4 and 5 cm)
~Alternating stance associated with ENT (cervical dilatation from 6 to 7 cm)
~Shower (with dilation> 7 cm);"
16172770|NCT01601860|Other|Other: Routine care|Other: Routine care Routine care of the institution performed by the staff, without the presence of the researcher that included offering a balanced meal, continuous support with the presence of a partner or family throughout labor, use of oxytocin when prescribed by the staff, use of drug analgesia when requested by the patient.
16172771|NCT01601847|Dietary Supplement|Cholecalciferol|Once the dietary intake of vitamin D has exceeded 200 IU/Day, the infants will receive placebo until they are 6 months of age adjusted for prematurity
16172772|NCT01601847|Drug|Cholecalciferol|Infants will receive cholecalciferol 400 IU/day PO until they are 6 months of age adjusted for prematurity
16172773|NCT01601834|Drug|PF-06273340 or Placebo|PF-06273340 will be administered as an extemporaneously prepared solution for all doses. Correspondingly, placebo doses will be administered as solution.
16172774|NCT01601834|Drug|PF-06273340 or Placebo|PF-06273340 will be administered as an extemporaneously prepared solution for all doses. Correspondingly, placebo doses will be administered as solution.
16172775|NCT01601821|Drug|CsA+Rapamune+CS|Part 1: Rapamune will be given as a loading dose of 6 mg once followed by maintenance dose of 2 mg to achieve a target trough level of 8-15 ng/ml. Part 2: Rapamune dose will be adjusted to achieve a target trough level of 10-15ng/ml through 6 months
16172776|NCT01601821|Drug|CsA+MMF+CS|"The control arm is the standard local practice (official protocol) in Iran:
~Cyclosporine + MMF + Corticosteroid. The time period is from pre-study screening / baseline evaluation up to 12 months for patients who are maintained on CsA + MMF + CS."
16172777|NCT01601808|Drug|Placebo|Orally once a day, continuously throughout the study
16172778|NCT01601808|Drug|Caprelsa (vandetanib)|Orally once a daily, continuously throughout the study.
16172779|NCT01601795|Drug|Sevoflurane|volatile Anaesthetic, duration during cardiopulmonary bypass
16172780|NCT01601795|Drug|Isoflurane|volatile anesthetic, duration during cardiopulmonary bypass time
16172781|NCT01601782|Procedure|Ultrasound Scan|Subject will be required to lie flat for no longer than 3 minutes to complete a volume imaging ultrasound scan of the injured area. Following the volume imaging scan a conventional ultrasound scan will be completed as ordered by their clinician.
16172782|NCT01601782|Device|Ultrasound Scan using a General Electric Ultrasound Scanner Model Logiq E9 (model name).|The subject will be required to lie flat for approximately 5 to 10 minutes to complete a conventional ultrasound scan to x-ray the muscle and tendon injuries.
16172783|NCT01601769|Device|Vitom|Patients treated and diagnosed by vitom
16172784|NCT01601769|Device|Colposcopy|"a Carl Zeiss colposcope with a magnification power from 4x to 20x, with green filter.
~Patients treated by colposcopy"
16173696|NCT01594749|Drug|Fosaprepitant dimeglumine|
16172785|NCT01601756|Device|navigated revision knee arthroplasty|revision knee arthroplasty with the aid of a navigation system the navigation system is the Orthopilot System with a software specifically dedicated for revision operations (TKR 1.0). The system is from Aesculap AG (Tuttlingen).
16172786|NCT01601756|Device|conventional revision knee arthroplasty|revision knee arthroplasty using conventional instruments
16172787|NCT01601743|Behavioral|Sitting|Sitting for the same period of time and duration (30 minutes per session, 3 times per week, over 4 consecutive weeks).
16172788|NCT01601743|Behavioral|Running|Exercise (running) for 30 minutes per session, 3 times per week, over 4 consecutive weeks.
16172789|NCT01601743|Behavioral|Walking|Exercise (walking) for 30 minutes per session, 3 times per week, over 4 consecutive weeks.
16172790|NCT01601730|Drug|Modafinil and Escitalopram|Treatment 4: Modafinil 200 mg + Escitalopram 20 mg
16172791|NCT01601730|Drug|Placebo|Matching oral placebo capsules as control (Treatment 1: Modafinil 0 + Escitalopram 0).
16172792|NCT01601730|Drug|Modafinil|Treatment 2: Modafinil 200 mg + Escitalopram 0.
16172793|NCT01601730|Drug|Escitalopram|Treatment 3: Modafinil 0 + Escitalopram 20 mg.
16172794|NCT01601717|Drug|RTI-336|Four medication dosage groups (0 mg, 1 mg, 12 mg, 20 mg) administered in the form of a pill once per day for 10 days.
16172795|NCT01601717|Drug|Placebo|Matching placebo pill administered once per day for 10 days.
16172796|NCT01601704|Drug|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day. Administered in addition to the weight management program.
16172797|NCT01601704|Drug|PBO|Placebo. Administered in addition to the weight management program.
16172798|NCT01601704|Behavioral|Weight Management Program|A comprehensive weight management program will be administered in addition to the subject's study medication assignment. The program includes internet counseling by an accredited health and fitness professional and a nutrition and exercise program with goal setting and educational and tracking tools.
16172799|NCT01601691|Device|DuraSeal|Single dose of DuraSeal product with DuraSeal components diluted 1:1 in sterile saline injected between rectum and prostate
16172800|NCT01601678|Procedure|Peroral Endoscopic Myotomy (POEM)|After lavage, measure gastro-esophageal junction (GEJ) in cm from mouth piece. Determine entry point 12-14cm above GEJ at the lesser curvature site, inject 10ml coloured saline, create entry point. Advance endoscope into the submucosa, dissect the submucosal tunnel up to 2-3cm into the cardia. Dissect the submucosa close to the muscularis and check endoluminally for the direction of the lesser curvature, sufficient extension onto the cardia and mucosal integrity. After tunnel completion flush with gentamycin and saline. Start myotomy from proximally to distally starting 4-5cm below the mucosal entry site; the inner circular muscle layer should be fully dissected especially at the cardia for good symptomatic results. It is vital that the mucosa of the tubular esophagus remains intact. Extend myotomy at least 2cm onto the cardia. After completion check for mucosal integrity and opening of the distal esophageal sphincter. Close the entry point with clips from distal to proximal.
16172801|NCT01601678|Procedure|Laparoscopic Heller Myotomy (LHM)|Use five trocar technique with patient in the French position as for laparoscopic anti-reflux procedures. Establish 12-15 mm Hg pneumoperitoneum. Use left paramedian trocar for camera, two lateral trocars for elevating liver and retraction of stomach and two trocars for dissection and suturing. Use of robotic surgery devices is allowed. Divide phrenoesophageal ligament starting on the right and mobilize distal esophagus on the lateral and anterior side. Identify and spare anterior vagal nerve. Perform myotomy by dividing both muscle-layers extending at least 6 cm above gastroesophageal junction and at least 2-3 cm inferiorly over stomach. Perform extent downwards after dividing epiphrenic fat pad overlying cardia. Measure myotomy length. Peroperative endoscopy check is advisable. Perform anterior fundoplication according to Dor. Only if necessary mobilize fundus of the stomach by dividing short gastric vessels. Suture fundus to both cut edges of myotomy, using non-resorbable material.
16172802|NCT01601665|Device|SN6AT6 Intraocular Lens|Acrylic intraocular lens with cylinder power at the IOL plane of 3.75 diopters. Intraocular lenses are implanted during cataract surgery as a replacement for the natural crystalline lens and are intended for long term use over the lifetime of the cataract subject.
16172803|NCT01601665|Device|SN6AT7 Intraocular Lens|Acrylic intraocular lens with cylinder power at the IOL plane of 4.50 diopters. Intraocular lenses are implanted during cataract surgery as a replacement for the natural crystalline lens and are intended for long term use over the lifetime of the cataract subject.
16172804|NCT01601665|Device|SN6AT8 Intraocular Lens|Acrylic intraocular lens with cylinder power at the IOL plane of 5.25 diopters. Intraocular lenses are implanted during cataract surgery as a replacement for the natural crystalline lens and are intended for long term use over the lifetime of the cataract subject.
16172805|NCT01601665|Device|SN6AT9 Intraocular Lens|Acrylic intraocular lens with cylinder power at the IOL plane of 6.00 diopters. Intraocular lenses are implanted during cataract surgery as a replacement for the natural crystalline lens and are intended for long term use over the lifetime of the cataract subject.
16172806|NCT01601665|Device|SN60WF Intraocular Lens|Acrylic aspheric monofocal intraocular lens. Intraocular lenses are implanted during cataract surgery as a replacement for the natural crystalline lens and are intended for long term use over the lifetime of the cataract subject.
16172807|NCT01601652|Drug|Omegaven|1 g/kg/d iv infusion over 24h
16172808|NCT01601639|Device|Endoscopic Band Ligation|Endoscopic band ligation device: 6 Shooter Saeed Multi-Band Ligator (Cook Medical/Endoscopy)
16172809|NCT01601639|Device|Argon plasma Coagulation (APC) for GAVE|APC treatment for gastric antral vascular ectasia (GAVE) Argon plasma coagulation device: ERBE VIO 300D (Elektromedizin GmBH)
16172810|NCT01601626|Drug|Standard-dose Lopinavir/Ritonavir|Two LPV 200 mg/RTV 50 mg fixed-dose combination tablets orally twice daily from entry to Week 72.
16172811|NCT01601626|Drug|Double-dose Lopinavir/Ritonavir|Four LPV 200 mg/RTV 50 mg fixed-dose combination tablets orally twice daily from entry through Week 72.
16172812|NCT01601626|Drug|Raltegravir|One 400 mg tablet orally twice daily from entry to Week 72.
16172813|NCT01601626|Drug|Isoniazid|300 mg orally once daily from entry through Week 24.
16172814|NCT01601626|Drug|Pyridoxine|25 mg orally once daily from entry to Week 24.
16172815|NCT01601626|Drug|Pyrazinamide|20 to 30 mg/kg orally once daily (not to exceed 2 g per day) from entry through Week 8 study visit (or until completion of intensive TB treatment as determined after dose adjustment in accrual period 1 participants).
16173182|NCT01598376|Procedure|7/0 vicryl suture|7/0 vicryl test suture placed as one of 3 everting sutures
16172816|NCT01601626|Drug|Ethambutol|15 to 20 mg/kg orally once daily from entry through Week 8 study visit (or until completion of intensive TB treatment as determined after dose adjustment in accrual period 1 participants).
16172817|NCT01601626|Drug|Rifabutin|300 mg of rifabutin orally once until LPV/RTV is started; then the dose will be reduced to 150 mg daily from the start of LPV/RTV through Week 24.
16172818|NCT01601626|Drug|Rifampin|Weight-based dose; for weight < 45 kg: 450 mg orally once daily; for weight > 45 kg: 600 mg orally once daily, from entry to week 24.
16172819|NCT01601613|Drug|activated recombinant human factor VII|100 mcg/kg body weight administered i.v. (into the vein) followed by standard haemostatic replacement therapy (SHRT) at the Investigator's discretion.
16172820|NCT01601613|Drug|placebo|100 mcg/kg body weight administered i.v. (into the vein) followed by standard haemostatic replacement therapy (SHRT) at the Investigator's discretion.
16172821|NCT01601600|Drug|BYM338|BYM338
16172822|NCT01601600|Drug|Placebo|BYM338 Placebo
16172823|NCT01601587|Other|A psychoeducational group intervention.|"The intervention is an introduction seminar. It will be held over FOUR hours. Up to 15 patients can participate in each seminar. The content of the was developed based on study 1. The presentation about available treatment options and patient's rights are made by multi professional health personnel and user representatives. More specifically, this will be done under the following topics:
~What is mental health?
~Treatment options: orientation about individual and group based treatment modalities.
~Former patients experience with their own treatment, self-help and participation.
~How to influence and participate actively in the treatment and patient rights.
~What can I do while I wait for treatment and where can I otherwise do to avoid aggravation?"
16172824|NCT01601574|Behavioral|Weight Watchers modified program|Weight Watchers: For people with Type 2 diabetes including (1) weekly standard in-person Weight Watchers meetings, (2) use of the standard Weight Watchers online program and tools, and (3) two scheduled telephone consultations with a Certified Diabetes Educator (CDE) who will assist the participant in tailoring the standard Weight Watchers program to accommodate the participant's diabetes-related status, with additional unlimited phone and email access to CDEs at the participant's request
16172825|NCT01601574|Other|Standard Care group|One session of in-person diabetic nutritional counseling with a registered dietitian, with follow-up written educational materials.
16172826|NCT01601561|Drug|Regular human insulin injection|"Hyperinsulinemic normoglycemic clamp from beginning of surgery until 8 hours after surgery.
~Humulin R 5 mU/kg/min and a variable infusion of glucose."
16172827|NCT01601548|Behavioral|Mindfulness Based Cancer Recovery|Defined as practices or interventions that focus on the connection and integration of the mind and body and the ability for these connections to effect changes on physical, emotional and spiritual levels for the purpose of promoting health and well being. MBCR is a psycho-educational program developed by Dr. Linda Carlson. It is a step by step mindful-based stress reduction program (MBSR) designed to help cancer patients cope with their cancer diagnosis and treatment
16172828|NCT01601535|Drug|MLN8237|Every course will be 21 days. MLN8237 will be administered orally daily starting on day 1 through day 7.
16172829|NCT01601535|Drug|Irinotecan|Irinotecan will be administered intravenously during each course on study day 1 through day 5.
16172830|NCT01601535|Drug|Temozolomide|Temozolomide will be administered orally during each course on study day 1 through day 5.
16172831|NCT01601522|Procedure|Peanut protein|500 mg
16172832|NCT01601522|Procedure|Oat flour|500 mg Oat flour
16172833|NCT01601509|Drug|Nasal tramazoline with dexamethazone|Every patient will undergo four assessments. Every assessment will consist of an overnight polysomnography with concomitant measurement of breathing route pattern (oral, nasal, oro-nasal breathing epochs) as previously described [7], along with a nasal resistance measurement. After baseline assessment and randomization patients of the first group will undergo a one-week therapy with nasal tramazoline and dexamethazone, while the patients of the second group will undergo a one-week therapy with nasal placebo (sodium chloride, 0.9% solution). The second assessment will take place at the end of this one week regimen. A washout period of two weeks will follow. Subsequently, the third assessment will take place and next the patients of the first group will undergo a one-week therapy with nasal placebo (sodium chloride, 0.9% solution), while the patients of the second group will undergo a one-week therapy with nasal tramazoline and dexamethazone. Fourth assessment will then follow.
16172834|NCT01601509|Drug|Nasal placebo|Every patient will undergo four assessments. Every assessment will consist of an overnight polysomnography with concomitant measurement of breathing route pattern (oral, nasal, oro-nasal breathing epochs) as previously described [7], along with a nasal resistance measurement. After baseline assessment and randomization patients of the first group will undergo a one-week therapy with nasal tramazoline and dexamethazone, while the patients of the second group will undergo a one-week therapy with nasal placebo (sodium chloride, 0.9% solution). The second assessment will take place at the end of this one week regimen. A washout period of two weeks will follow. Subsequently, the third assessment will take place and next the patients of the first group will undergo a one-week therapy with nasal placebo (sodium chloride, 0.9% solution), while the patients of the second group will undergo a one-week therapy with nasal tramazoline and dexamethazone. Fourth assessment will then follow.
16172835|NCT01601496|Device|FUSION Vascular Graft|All subjects who received the FUSION Vascular Graft at the baseline implant procedure.
16172836|NCT01601483|Drug|MC-1101|1% Ophthalmic Solution TID
16172837|NCT01601483|Drug|MC-1101 Vehicle|Ophthalmic solution, TID
16172838|NCT01601470|Drug|LCZ696|LCZ696 400mg QD was administered alone for 4 days and in combination with sildenafil for 1 day
16172839|NCT01601470|Drug|Sildenafil|Sildenafil 50 mg single dose was administered alone for 1 days and in combination with LCZ696 400mg QD for 1 day
16172840|NCT01601457|Drug|activated recombinant human factor VII|90 mcg/kg body weight administered intravenously as a slow, bolus injection after the patients had been anaesthetised and immediately before the first skin incision. A second dose was given if an intraoperative haemoglobin was less than 8.0 g/dl after salvaged red cells (RBC) had been re-transfused
16172841|NCT01601457|Drug|placebo|Administered intravenously as a slow, bolus injection after the patients had been anaesthetised and immediately before the first skin incision. A second dose was given if an intraoperative haemoglobin was less than 8.0 g/dl after salvaged red cells (RBC) had been re-transfused
16172842|NCT01601444|Device|Pletysmograph|Pletysmograph electrodes are applied to the thoracic wall
16172843|NCT01601431|Device|Cap Assisted Colonoscopy|Plastic transparent cap added to the distal end of the colonoscope which can increase adenoma detection rate
16172844|NCT01601431|Device|Conventional colonoscopy|Regular colonoscopy as per standard clinical guidelines
16172845|NCT01601418|Drug|YF476|Each subject took one capsule of YF476 (1, 5, 25 or 100 mg) or placebo on five separate occasions. Each capsule was taken with water 150 mL.
16172846|NCT01601418|Drug|Placebo|Each subject took one capsule of YF476 (1, 5, 25 or 100 mg) or placebo on five separate occasions. Each capsule was taken with water 150 mL.
16172847|NCT01601405|Drug|YF476|Each subject took one capsule of YF476 100 mg twice daily on Days 1-6 and once on Day 7. Each capsule taken with water 150 mL.
16172848|NCT01601405|Drug|Placebo|On Days 0 and 14, each subject took a placebo capsule. Each capsule taken with water 150 mL.
16172849|NCT01601392|Procedure|transcranial direct current stimulation (Anodal)|The anodal group will receive tDCS for 25 minutes at 2mA daily for 6 consecutive days on the affected hemisphere.
16172850|NCT01601392|Procedure|transcranial direct current stimulation (Cathodal)|The Cathodal group will receive tDCS for 25 minutes at 2mA daily for 6 consecutive days on the unaffected hemisphere.
16172851|NCT01601392|Procedure|transcranial direct current stimulation (Sham)|The sham group will receive sham tDCS for 25 minutes daily for 6 consecutive days on the affected hemisphere.
16172852|NCT01601366|Device|LNG-IUS|"The study includes 2 treatment groups: Group I the LNG-IUS group where they will have a LNG IUS inserted for them"
16172853|NCT01601366|Drug|Combined oral contraceptives|Group II: will recite combined oral contraceptives for 6 months
16172854|NCT01601353|Device|Tissue Genesis Cell Isolation System|Liposuction followed by injection of autologous adipose derived cells
16172855|NCT01601340|Drug|HQK-1001|HQK-1001 tablets, twice daily for 48 weeks
16172856|NCT01601340|Drug|Placebo|Placebo tablets, twice daily for 48 weeks
16172857|NCT01601327|Drug|Testosterone enanthate (Sustanon 250 mg)|Twenty-eight patients were treated with testosterone enanthate (TE),
16172858|NCT01601327|Drug|Human chorionic gonadotropin (hCG) (Pregnyl 5000 IU)|twenty-five patients were treated with human chorionic gonadotropin (hCG)
16172859|NCT01601327|Drug|Testosteron gel (Testojel 50 mg)|Twenty-four patients were treated with testosterone gel (TG).
16172860|NCT01601314|Drug|Magnesium Sulfate|"At the beginning of the neurosurgery, the subjects are going to receive one 4gr bolus in Sodium Chloride 100 mL, lasting 20 minutes, intravenously.
~After that, a intravenously perfusion of Magnesium Sulfate 20 gr, in Sodium Chloride 1000 mL, lasting 24 hours, will be started."
16172861|NCT01601314|Other|Sodium Chloride|"At the beginning of the neurosurgery, the subjects are going to receive a bolus of Sodium Chloride 100 mL, lasting 20 minutes, intravenously.
~After that, a intravenously perfusion of Sodium Chloride 1000 mL, lasting 24 hours, will be started."
16172862|NCT01601301|Device|PRECICE System|Lenthening of either the tibia or femur with the PRECICE System.
16172863|NCT01601262|Device|Low Intensity Extracorporeal Shock waves (Cardiospec 1000)|We will apply the cardiospec 1000 unit for LI-ESWL in the penile and inguinal areas, 300 shocks per area, total of 1500 shocks. Full description of treatment series can be seen in the detailed protocol.
16172864|NCT01601249|Procedure|Embryo selection based on polscope grading or morphology|In the experimental arm embryo grading will be performed by polscope rather than conventional morphology, and the best embryo/s for transfer will be selected by this method.
16172865|NCT01601236|Drug|Repository Corticotropin Injection|H.P. Acthar Gel (repository corticotropin injection) is administered via daily SC injection for 36 weeks in the three dose groups [8 U (0.1 mL), 16 U (0.2 mL), or 32 U (0.4 mL)].
16172866|NCT01601236|Drug|Placebo|Placebo contains the same inactive ingredients as H.P. Acthar Gel without the active pharmaceutical ingredient (API). Placebo is administered via daily SC injection for 36 weeks in equal volumes as the Acthar comparator volumes.
16172867|NCT01601210|Drug|Creatine monohydrate or placebo|Placebo, 2g, 4g, and 10g of creatine monohydrate
16172868|NCT01601197|Behavioral|Tactile stimulation|Immunizer will rub the ipsilateral limb before, during and after immunization injection(s)
16172869|NCT01601184|Drug|vismodegib|Hedgehog pathway antagonist Dosage: 150 mg orally with or without food at the same time every day
16172870|NCT01601184|Drug|Temozolomide|alkylating agent Dosage: Dose in Cycle 1 is 150 mg/m2 orally once daily for 5 days followed by 23 days without treatment. At the start of Cycle 2, the dose is escalated to 200mg/m2 orally once daily for 5 days
16172871|NCT01601158|Biological|Umbilical Cord Blood administration|The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression.
16172872|NCT01601158|Other|Active Rehabilitation|All subjects should participate in active rehabilitation. They will receive two physical and occupational therapy sessions per day. Post discharge, each participant should continue to receive rehabilitation therapy at least 3 days per week until the study completion.
16172873|NCT01601145|Dietary Supplement|consumption of lozenges|Each subject two lozenges a day for 6 weeks
16172874|NCT01601132|Drug|theophylline|300mg (80mg/15ml elixir)
16172875|NCT01601132|Drug|colchicine|colchicine 0.6mg by mouth twice daily on Days 5-19, co-administered with theophylline 300mg (80mg/15ml) on the morning of Day 19
16172876|NCT01601119|Drug|Rebif|The subjects will receive Rebif as per the current practices or as directed by the physician.
16172877|NCT01601119|Other|Other: Disease modifying therapies (DMT)|The subjects will receive other DMTs as per the current practices or as directed by the physician.
16172878|NCT01601106|Drug|liposomal prednisolone|Two weekly dosages with 150 mg.
16172879|NCT01601106|Drug|Placebo|
16172880|NCT01601093|Drug|High dose|Ceftazidime 3g, iv, bid and Sulbactam Sodium 1.5g, iv, bid for 5-14days.
16172881|NCT01601093|Drug|Low dose|Ceftazidime 2g, iv, bid and Sulbactam Sodium 1g, iv, bid for 5-14days.
16172882|NCT01601093|Drug|Cefoperazone and Sulbactam Sodium (CFP/SUB)|Cefoperazone 2g, iv, bid and Sulbactam Sodium 1g, iv, bid for 5-14days.
16172883|NCT01601067|Behavioral|Integrated Prolonged Exposure Therapy|Prolonged exposure (PE) therapy is an evidence based practice for the treatment of PTSD. Components of PE included education about PTSD and exposure to avoided reminders of trauma.
16172911|NCT01600820|Other|3- Low fat drinkable fermented dairy product without plant sterols(control)|3 = Intervention 3 (1 control product/day)
16172884|NCT01601067|Behavioral|Seeking Safety|Seeking Safety (SS) teaching coping skills in behavioral, cognitive, and interpersonal domains so that people are able to make safe choices rather than drinking or PTSD-related behaviors such as avoidance.
16172885|NCT01601054|Device|Tantalum cage from Zimmer|A tantalum cage will be inserted through a left sided retroperitoneal approach
16172886|NCT01601041|Other|sonographic assessment of residual urine, urine culture|residual urinary volume assessed by ultrasound after bladder catheterization urinary cultures taken before and after prostate massage
16172887|NCT01601028|Drug|Hydroxychloroquine|Hydroxychloroquine 300 mg once daily p.o. for 12 weeks and go off medication for 4 weeks (total 16 weeks)
16172888|NCT01601028|Drug|Placebo|2cp/day for 12 weeks and go off medication for 4 weeks (total 16 weeks)
16172889|NCT01601015|Other|Manual Therapy|Manual therapy of Suboccipital soft tissue Inhibition is performed with patient in supine position. The patient's head leans against the physiotherapist's hands, which palpate suboccipital muscles by sliding fingertips until contacting posterior arch of atlas. At this point, a deep and progressive gliding pressure is applied, for 10 minutes. The purpose of this technique is to release suboccipital muscle spasm, which can be responsible for the mobility dysfunction of the occiput-atlas-axis joint.
16172890|NCT01601015|Other|Manual Therapy|Occiput-atlas-axis joint manipulation is performed in the same position as the previous technique. It is bilaterally administered and it consists of 2 phases: firstly, rotation with gentle head decompression with no flexo-extension and slight lateral flexion is performed, followed by small circumductions aimed at increasing arterial viscoelasticity and searching for adequate joint barrier through selective tension; secondly, a high speed thrust manipulation in pure rotation towards the side to be manipulated is performed, with a head helicoidal movement, with the aim of restoring the mobility of joints between occiput, atlas and axis, which enables to correct a global joint dysfunction.
16172891|NCT01601015|Other|Manual Therapy|Occiput-atlas-axis joint manipulation is performed in the same position as the previous technique. It is bilaterally administered and it consists of 2 phases: firstly, rotation with gentle head decompression with no flexo-extension and slight lateral flexion is performed, followed by small circumductions aimed at increasing arterial viscoelasticity and searching for adequate joint barrier through selective tension; secondly, a high speed thrust manipulation in pure rotation towards the side to be manipulated is performed, with a head helicoidal movement, with the aim of restoring the mobility of joints between occiput, atlas and axis, which enables to correct a global joint dysfunction.
16172892|NCT01601015|Other|placebo treatment|"The physiotherapist performed the vertebral artery test bilaterally, followed by a two-minute neck massage without lubricants and with no proven therapeutic effect, as a placebo for all study groups.
~The control group received four sessions of placebo treatment, followed by ten minutes of resting position."
16172893|NCT01601002|Drug|Mirtazapine|Mirtazapine 7.5 to 45 mg/day, once daily, 12 weeks open label
16172894|NCT01600989|Other|blood sampling|Blood samples will be taken at ICU admission, and 24h and 48h after admission, and at time of resolution of sepsis
16172895|NCT01600989|Other|blood sampling|Blood samples will be taken twice at a 7 day interval
16172896|NCT01600976|Drug|telaprevir|Type=exact number, unit=mg, number=375, form=tablet, route=oral. Multiple doses of 2 oral tablets of telaprevir will be administered every 8 hours on Days 1 to 5 and a single dose of 2 oral tablets of telaprevir will be administered in the morning on Day 6.
16172897|NCT01600963|Drug|Arm A Double-blind Phase: TMC207|Type=exact number, unit=mg, number=400 mg for the first 2 weeks and 200 mg 3 times per week for the remainder of the treatment period, form=tablet, route=oral administration.
16172898|NCT01600963|Drug|Arm B Double-blind Phase: Placebo|Form=tablet, route=oral administration, taken once daily for 2 weeks then 3 times per week for the remainder of the treatment period.
16172899|NCT01600963|Drug|Treatment Failure During Double-blind Phase: TMC207|Type=exact number, unit=mg, number=200 mg 3 times per week, form=tablet, route=oral administration.
16172900|NCT01600963|Drug|Treatment Failure During Follow-up Phase: TMC207|Type=exact number, unit=mg, number=400 mg once daily for 2 wks and 200mg three times per week for 22 weeks, form=tablet, route=oral administration.
16172901|NCT01600950|Drug|LY2963016|Single 0.3 U/kg dose administered subcutaneously
16172902|NCT01600950|Drug|Lantus|Single 0.3 U/kg dose administered subcutaneously
16172903|NCT01600937|Behavioral|Theoretical & practical exercise counseling|2 sessions/ per wk for 1 month
16172904|NCT01600911|Other|Low phytochemical diet(LPD), high phytochemical diet(HPD)|LPD is a basal diet which low in soy,vegetable and fruit and other plant food to approach low phytochemical. HPD is the diet which add two serving test vegetable in the lunch of LPD.
16172905|NCT01600885|Drug|Guanfacine|Subjects will be given 3mg of guanfacine before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) will be given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant will receive a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation will be measured during a spatial working memory task. The entire scan will last approximately two and a half hours and the ketamine infusion will be up to one hour and 15 minutes.
16172906|NCT01600885|Drug|Placebo|Subjects will be given a placebo before the fMRI scan. Then when in the scanner, a bolus of ketamine (0.23mg/kg over 1 min) will be given during the visual fixation scan. Immediately after completion of the 1 min bolus, the participant will receive a steady state ketamine infusion of 0.58 mg/kg/hour and brain activation will be measured during a spatial working memory task. The entire scan will last approximately two and a half hours and the ketamine infusion will be up to one hour and 15 minutes.
16172907|NCT01600859|Drug|E2609|"E2609 capsules: 5 mg, 25 mg, 50 mg, and 200 mg
~E2609 doses: 5 mg, 10 mg, 25 mg, 50 mg, 100 mg, 200 mg, and 400 mg
~According to the randomized study design, participants who are assigned to receive E2609 will each receive a single assigned dose consisting of two capsules of E2609 or in some cases one capsule of E2609 and one of placebo"
16172908|NCT01600859|Drug|Placebo for E2609|"Placebo capsules
~According to the randomized study design, participants who are assigned to receive placebo will each receive a single dose consisting of two capsules of placebo"
16172909|NCT01600820|Other|1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit|1 = Intervention 1 (1 test product/day)
16172910|NCT01600820|Other|2- Low fat drinkable fermented dairy product enriched with 2.0g of plant sterol (as free equivalent) per unit|2 = Intervention 2 (1 test product/day)
16172912|NCT01600807|Drug|Gemcitabine, Erlotinib, OSI-906|Gemcitabine 1000 mg/m2 d1,8,15; Erlotinib 100 mg QD, OSI-906 dose to be determined BID
16172913|NCT01600807|Drug|Gemcitabine, Erlotinib|Gemcitabine 1000 mg/m2 d1,8,15; Erlotinib 100 mg QD
16172914|NCT01600781|Dietary Supplement|NutriniDrink/Fortini MF unflavoured (1.5kcal/ml)|During the 6-week Intervention period children allocated to group 1 will consume 2 bottles of study product per day (400ml in total).
16172915|NCT01600768|Drug|Beta-Lactams|infusion time: 30 mins or 1 hr
16172916|NCT01600768|Drug|Beta-Lactams|infusion time 4 hrs
16172917|NCT01600755|Biological|Autologous Muscle-Derived Cells (AMDC)|Cell Treatment
16172918|NCT01600742|Drug|Vorinostat|"Run-in phase:
~WBRT: 2.5 Gy per fraction per day, day 1 through day 5 every week for 15 days, to a total dose of 37.5Gy.
~Vorinostat: 400 mg/day during WBRT, day 1 through day 7 every week till one day after WBRT.
~Randomization phase:
~WBRT: 2.5 Gy per fraction per day, day 1 through day 5 every week for 15 days, to a total dose of 37.5Gy.
~Vorinostat or placebo: 400 or 300 mg/day during radiation therapy (based on the results of run-in phase), day 1 through day 7 every week till one day after WBRT."
16172919|NCT01600742|Drug|Placebo|"Randomization phase:
~WBRT: 2.5 Gy per fraction per day, day 1 through day 5 every week for 15 days, to a total dose of 37.5Gy.
~Vorinostat or placebo: 400 or 300 mg/day during radiation therapy (based on the results of run-in phase), day 1 through day 7 every week till one day after WBRT."
16172920|NCT01600729|Drug|No Intervention|No intervention.
16172921|NCT01600716|Biological|OnabotulinumtoxinA|OnabotulinumtoxinA 100 U is administered into the detrusor at Day 1 in the onabotulinumtoxinA 100 U arm. After a minimum of 12 weeks, patients in both the onabotulinumtoxinA 100 U arm and the placebo arm could request/qualify for an onabotulinumtoxinA injection.
16172922|NCT01600716|Drug|Placebo (Normal Saline)|Placebo (normal saline) is administered into the detrusor at Day 1.
16172923|NCT01600703|Drug|Sitagliptin|Sitagliptin, 100mg, oral, single dose
16172924|NCT01600703|Drug|Placebo|Placebo, oral, single dose
16172925|NCT01600690|Other|Statin withdrawal|Patients are instructed to stop taking statin pills for the duration of the study. The rest of therapy will remain unchanged.
16172926|NCT01600677|Device|Computerized medication delivery unit|The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. EMMA identifies each medication automatically-no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. EMMA will remain in the patient's home for a period of 90 days immediately following hospitalization. After 90 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit form the MDU, while addressing the transition period when medication-reconciliation problems are most common.
16172927|NCT01600677|Other|Usual care|Those hospitalized patients that meet all inclusion and exclusion criteria will receive medications from a dedicated pharmacy, but continue to make their medications in their usual way for the 90-day period immediately following discharge.
16172928|NCT01600664|Behavioral|Interactive computer game|Participants will use the interactive computer game installed on a convertible PC
16172929|NCT01600664|Behavioral|Convertible PC|Participants will be using the convertible PC without the interactive computer game
16172930|NCT01600651|Other|Recruitment Maneuver (RM) sham group|It 's when RM sequence precedes a shame evaluation period
16172931|NCT01600651|Other|Sham recruitment maneuver (RM) group|Group in which patients receive a sham sequence before the RM sequence
16172932|NCT01600638|Device|The Zeltiq System|Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
16172933|NCT01600625|Drug|oral minocycline hydrochloride treatment|Orally received 50 mg minocycline (Minocin, SK chemical, Seoul, Korea) twice a day for 2 months treatment
16172934|NCT01600612|Drug|carbetocin|10 ug of carbetocin will be given intravenously to patients with atonic postpartum hemorrhage
16172935|NCT01600612|Drug|misopristol|600 ug of misopristol will be given sublingually to patients with atonic postpartum hemorrhage
16172936|NCT01600612|Drug|oxytocin|30 IU of oxytocin will be given intravenously to patients with atonic postpartum hemorrhage
16172937|NCT01600599|Drug|Tranexamic Acid|intravenous 1g and topical 1g
16172938|NCT01600599|Drug|saline|100mls of topical saline
16172939|NCT01600586|Device|Pacifier-Activated-Lullaby system (PAL).|Pacifier-Activated-Lullaby system (PAL).
16172940|NCT01600573|Drug|pazopanib in combination with weekly topotecan|"Topotecan as an IV infusion over 30 minutes on days 1, 8, and 15 of a 28 day cycle and
~Pazopanib orally once daily continuous dosing in the following dose levels:
~Phase I Trial:
~Dose level -I: Topotecan weekly 3mg/m2, Pazopanib 400 mg Dose level I: Topotecan weekly 4mg/m2, Pazopanib 400 mg Dose level II: Topotecan weekly 4mg/m2, Pazopanib 600 mg Dose level III: Topotecan weekly 4mg/m2, Pazopanib 800 mg
~Phase II Trial:
~Phase II will either use the MTD as determined in Phase I or a lower dose if deemed necessary."
16172941|NCT01600534|Behavioral|lifestyle counseling|Participants receive lifestyle counseling on healthy eating and physical activity through an internet-based program or self-directed educational program.
16172942|NCT01600521|Drug|A Natural Remedy for Rheumatoid Arthritis vs. Common Drugs|The comparisons of the efficacy and safety of the following treatments for rheumatoid arthritis: paeoniflorin (PAE) + Cervus and Cucumis polypeptide injection (CCPI), methotrexate (MTX) + leflunomide (LEF), and MTX + LEF + CCPI.
16172943|NCT01600508|Other|Videoconference stoma care|Stoma patients are randomized to videoconference stoma care or surgical outpatients clinic stoma care
16172944|NCT01600495|Other|Experimental TENS|Use of Transcutaneous Nerve Electrical Stimulation in the lumbosacral region for 30 continuous minutes in the active phase of labor (4-5 cm).
16172945|NCT01600482|Device|CELT ACD|The CELT ACD will be used to achieve hemostasis of the common femoral artery in patients on anticoagulation who are undergoing a percutaneous intervention procedure using a 6F procedural sheath.
16172946|NCT01600469|Drug|DAOI-B|250-1500 mg/day, oral, for 24 weeks
16172947|NCT01600469|Other|Placebo|placebo, oral, for 24 weeks
16172948|NCT01600456|Behavioral|Prolonged exposure (PE)|PE will include 10 weekly sessions of individual cognitive behavioral therapy.
16172949|NCT01600456|Other|PE plus Sertraline|PE plus sertraline will include 10 weeks of prolonged exposure therapy plus sertraline. The sertraline dose will be up to 200 mg daily for 10 weeks. There will also be frequent meetings with study psychiatrist. PE will be provided 1x weekly for 10 weeks.
16172951|NCT01600443|Device|SpeediCath|Three catheterizations at least two hours apart using SpeediCath 40 cm CH14.
16172952|NCT01600443|Device|SpeediCath Compact Male|Three catheterizations at least two hours apart using SpeediCath Compact Male 30 cm.
16172953|NCT01600430|Dietary Supplement|Cholecalciferol|200 IU/day given orally once per day as one of 4 doses of 0.5ml each given every 6 hours. Other 3 doses will be placebo (sterile water). Duration of 28 postnatal days
16172954|NCT01600430|Dietary Supplement|Cholecalciferol|800 IU/day given orally per day as 4 doses of 200 IU/0.5ml each every 6 hours. Duration of 28 postnatal days
16172955|NCT01600430|Dietary Supplement|Placebo|Sterile water 0.5ml given orally every 6 hours. Duration of 28 postnatal days
16172956|NCT01600404|Drug|antimuscarinic treatment|
16172957|NCT01600391|Behavioral|Usual care|Walking rehabilitation for 1 hour, 2 times per week and 8 weeks duration. Usual care intervention that does not include use of visual cues to influence quality or adaptability of gait.
16172958|NCT01600391|Behavioral|Overground visual cue training|Walking rehabilitation for 1 hour, 2 times per week and 8 weeks duration. Overground visual cue training will involve stepping to targets, which are positioned to improve walking pattern according to needs identified in baseline assessment. Treatment will progress from practice of improved stepping pattern (symmetry of stepping) and speed to practice of adjusting footfalls by avoiding targets randomly, as one might need to be able to do to avoid an obstacle or an uneven surface. Training will also involve turning practice.Overground visual cue training will be delivered by National Health Service therapists in participating National Health Service sites.
16172959|NCT01600391|Behavioral|Treadmill visual cue training|Walking rehabilitation for 1 hour, 2 times per week and 8 weeks duration. Treadmill training with visual cues will be delivered using a force-instrumented treadmill (CMill, Forcelink, NL). The Treadmill visual cue training will involve participants stepping to targets shone onto a treadmill. Treatment will progress from practice of improved stepping pattern (symmetry of stepping) and speed to practice of adjusting footfalls by avoiding targets randomly, as one might need to be able to do to avoid an obstacle or an uneven surface. Training will also involve turning practice. Treadmill visual cue training will be delivered by qualified physiotherapists at the University of Birmingham.
16172960|NCT01600365|Drug|Ophthalmic gel (placebo)|Ophthalmic gel (placebo): applied in affected eye 4 times daily for 10 days
16172961|NCT01600365|Drug|Ganciclovir|Ophthalmic gel ganciclovir 0,3%: applied in affected eye 4 times daily for 10 days
16172962|NCT01600339|Drug|CABAZITAXEL|The patients are planned to receive cabazitaxel at a starting dose of 25 mg/m(2) intravenously over 1 h, following premedication as accepted with cabazitaxel. Treatment cycles are every 3 weeks. All patients will receive primary GCSF support.
16172963|NCT01600326|Procedure|Tenotomy (no injection)|Subjects randomized to this group will fill out a pre-treatment pain survey and have a blood draw They will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti-inflammatory medications for 2 weeks before the study. Two weeks after enrollment subjects see their referring physician to begin physical therapy.
16172964|NCT01600326|Drug|Ultrasound guided platelet rich plasma injection|"Subjects will fill out a pre-treatment pain survey, then will undergo ultrasound and have blood drawn from their arm.
~The blood sample will be separated into blood cells and plasma. The plasma portion of the blood (liquid minus the cells) will be injected into the tendon under sterile conditions. Ultrasound will help guide the injection. This is called Ultrasound guided platelet rich plasma injection.
~Subjects will be be contacted by the investigator by telephone or email on day 7 and day 14 to complete another pain survey. Subjects must avoid non steroidal anti inflammatory medications for 2 weeks before the study and 2 weeks after the study.
~Subjects will see their referring physician two weeks after treatment to begin physical therapy."
16172965|NCT01600313|Dietary Supplement|rice bran oil|Treatment group received the low - calorie diet with(30g/day) rice bran oil
16172966|NCT01600300|Device|Tesmac|Subjects were treated twice daily for five consecutive days, followed by two days untreated, and then treated twice daily for five more consecutive days.
16172967|NCT01600300|Device|Sham Tesmac device|Treatment with inactivated Tesmac device on the same schedule as the group treated with the active Tesmac device.
16172968|NCT01600287|Other|IAADS|"In automatic mode, the system requests an update of the BIS data every 5 seconds and calculates the BIS error (difference between the target and actual BIS value). This value along with the trends of BIS in the epoch of the last 30 seconds as well as in the last 5 minutes is passed on to a patient individualized, model based adaptive control algorithm. The algorithm uses the error to calculate an adjustment to the propofol delivery rate, but does not apply it immediately. Adjustments to the propofol delivery rate are only made every 30 seconds, taking into account the sum of previous six BIS error values, the trends of BIS in the epoch of last 30 seconds as well as in the last 5 minutes, time elapsed since the initiation of infusion, pharmacokinetics, the time delay factor between sensing and averaging of BIS data, the time delay factor between the change in infusion rate and the actual change in the plasma concentration of propofol as well as the peak effect of propofol."
16172969|NCT01600287|Other|Manual propofol administration|"In manual mode, the user can also control the propofol infusion rate manually, using the keyboard or the mouse of the PC. The PC displays a graph of the propofol delivery rate and trend of BIS value."
16172970|NCT01600274|Drug|Dienogest-Ethinyl Estradiol (test product)|One tablet of Test
16172971|NCT01600274|Drug|Dienogest-Ethinyl Estradiol (reference product)|One tablet of Reference
16172972|NCT01600248|Behavioral|Online ABBT for Chronic Pain in Military|Participants will complete an 8-module, self-paced, online program for chronic pain using Acceptance-Based Behavioural Therapy (ABBT) as the therapeutic modality.
16172973|NCT01600235|Drug|Phenylephrine|Phenylephrine (0.12mg/mL) Starting dose: 10cc/hr Titration: increase 10cc/hr every 30-60min, maximum 160cc/hr rate: increase systolic blood pressure (SBP) 10-25mmHg /hr Target: initially 20% increase of initial SBP, up to improving NIHSS score or SBP 200mmHg
16172974|NCT01600222|Drug|LEO 90100|Calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate)
16172975|NCT01600196|Procedure|Liver resection plus Thrombectomy|Liver resection plus Thrombectomy
16172976|NCT01600183|Device|UNFO-s|The UNFO-s is a foot orthosis used to treat congenital foot malformations in infants
16172977|NCT01600183|Procedure|cast|casting of the infant legs
16173022|NCT01599819|Biological|PEGylated Recombinant Factor VIII|1 PK infusion of BAX 855 (low dose in Cohort 1, high dose in Cohort 2)
16172978|NCT01600170|Drug|Atorvastatin (generic Lipitor)|Atorvastatin is an FDA approved prescription drug which is frequently used to lower cholesterol levels.It is available in the form of tablets ranging in dose from 10-80mg.
16172979|NCT01600170|Drug|placebo|A substance containing no medication and prescribed or given to reinforce a patient's expectation to get well.
16172980|NCT01600157|Procedure|Ambulant laparoscopic nephrectomy|The patients with a renal cancer diagnosis with be schedule to enter the project if they meet the inclusion criteria of the project and the postoperative period will be recorded to identified the limiting factors for ambulant laparoscopic nephrectomy.
16172981|NCT01600144|Other|digital mammography|data collection
16172982|NCT01600131|Behavioral|Caregiver problem-solving|This is a problem-solving intervention for stroke caregivers that can be delivered shortly after the Veteran's in-patient stays followed by online, in-home sessions. The investigators will modify the traditional, problem-solving intervention by adding web-based training using interactive modules, factsheets, and tools on the investigators' previously developed and nationally available RESCUE Caregiver website (www.ciddr8.research.va.gov/rescue). The investigators will also provide on-line, skills training and application of the problem-solving approach via the RESCUE messaging center.
16172983|NCT01600131|Other|Standard Care|No intervention or treatment will be provided. The investigators will closely monitor the usual care that is provided to caregivers.
16172984|NCT01600118|Device|Extracorporeal shockwave therapy|1000 impulses
16172985|NCT01600118|Device|No extracorporeal shockwave|0 impulses, acoustic effect
16172986|NCT01600105|Drug|Perfusion MRI|1) Assess the role of a new FDA approved blood pool gadolinium contrast agent (gadofosveset trisodium, Ablavar, Lantheus) for the measurement of liver MR Perfusion, compared to extra-cellular contrast agents.
16172987|NCT01600092|Biological|RotaTeq™ experimental formulation|
16172988|NCT01600092|Biological|RotaTeq™ existing formulation|
16172989|NCT01600079|Biological|ZOSTAVAX™|ZOSTAVAX™ (Zoster Vaccine Live) administered in routine clinical conditions of use
16172990|NCT01600053|Drug|Lenalidomide|Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each.
16172991|NCT01600040|Radiation|Proton radiation therapy|5 days per week (Mon-Fri) for 5-6 weeks
16172992|NCT01600027|Procedure|Fascia iliaca compartment block|Fascia iliaca compartment block was performed as described by Dalens et al technique.
16172993|NCT01600027|Procedure|Fascia iliaca block|Fascia iliaca compartment block was performed as described by Dalens et al technique.
16172994|NCT01600014|Drug|Ingenol mebutate gel, 0.015%|Topical field treatment once daily for 3 consecutive days within a 25 cm2 treatment area on the face or scalp of AKs present or emerging after an initial treatment with ingenol mebutate gel, 0.015%
16172995|NCT01600014|Drug|Vehicle gel|Topical field treatment once daily for 3 consecutive days within a 25 cm2 treatment area on the face or scalp of AKs present or emerging after an initial treatment with ingenol mebutate gel, 0.015%
16172996|NCT01600001|Drug|KWA-0711|
16172997|NCT01600001|Drug|Placebo|
16172998|NCT01599988|Dietary Supplement|Caseinate|The test meal is a vanilla flavoured enteral drink, containing 1.5kcal/ml, 21% CHO, 6% protein and 5% fat. The 6% protein in this test meal is Caseinate
16172999|NCT01599988|Dietary Supplement|Milk Protein Isolate|The test meal is a vanilla flavoured enteral drink, containing 1.5kcal/ml, 21% CHO, 6% protein and 5% fat. The 6% protein in this test meal is Milk Protein Isolate.
16173000|NCT01599975|Drug|Long acting methylphenidate|Treatment with long-acting methylphenidate, 36 mg a day as 2 tablets of 18 mg each.
16173001|NCT01599975|Drug|Long acting methylphenidate|18 mg tablets, 2 tablets daily by mouth x 2 weeks, then washout x 2 weeks, then crossover to 2 tablets of matched placebo x 2 weeks.
16173002|NCT01599975|Drug|Matched placebo|2 tablets of matched placebo daily by mouth
16173003|NCT01599962|Drug|Cinacalcet|single administration, 90mg
16173004|NCT01599962|Drug|Placebo|single administration
16173005|NCT01599949|Drug|Ibrutinib|Type=exact number, unit=mg, number=560, form=capsule, route=oral use. 560 mg oral ibrutinib is to be administered once daily continuously until disease progression, unacceptable toxicity, or study end, whichever occurs first. Doses can be held or reduced based on the severity of and the recovery from side effects of the study drug.
16173006|NCT01599936|Biological|Anascorp|3 vials of Alacramyn reconstituted in 50 ml of normal saline as an IV infusion over 10 minutes.
16173007|NCT01599923|Biological|Antivenin Centruroides (scorpion) equine immune F(ab')2|3 vials of Alacramyn reconstituted in 50 ml of normal saline as an IV infusion over 10 minutes.
16173008|NCT01599910|Other|Scribes|Scribe
16173009|NCT01599897|Biological|ID93 + GLA-SE|ID93 antigen and GLA-SE adjuvant. 3 injections at Days 0, 28, and 56.
16173010|NCT01599897|Biological|ID93 alone|ID93 antigen alone. 3 injections and Days 0, 28, and 56.
16173011|NCT01599884|Drug|N-acetylcysteine|1800 mg twice daily for 8 weeks
16173012|NCT01599884|Drug|Oral acetylcysteine|Identical placebo pills twice daily for 8 weeks
16173013|NCT01599871|Drug|theophylline|theophylline 100 mg, twice at day
16173014|NCT01599871|Other|placebo|Placebo
16173015|NCT01599858|Drug|YF476|There were 4 treatments as follows: YF476 25mg twice daily, YF476 100mg twice daily, placebo and omeprazole 20mg once daily. Each treatment was taken by mouth for 7 days. Each subject took 1 of the 4 treatments.
16173016|NCT01599858|Drug|Omeprazole|There were 4 treatments as follows: YF476 25mg twice daily, YF476 100mg twice daily, placebo and omeprazole 20mg once daily. Each treatment was taken by mouth for 7 days. Each subject took 1 of the 4 treatments.
16173017|NCT01599832|Drug|pazopanib hydrochloride|Given PO
16173018|NCT01599832|Other|laboratory biomarker analysis|Correlative studies
16173019|NCT01599832|Procedure|dynamic contrast-enhanced magnetic resonance imaging|Undergo dynamic contrast-enhanced magnetic resonance imaging
16173020|NCT01599832|Other|pharmacogenomic studies|Correlative studies
16173021|NCT01599819|Biological|Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method|1 PK infusion of ADVATE (low dose in Cohort 1, high dose in Cohort 2)
16173100|NCT01599104|Drug|Olmesartan|Olmesartan 20 mg capsule one daily
16173023|NCT01599806|Drug|Ceftazidime - Avibactam ( CAZ-AVI)|Ceftazidime 2000 mg and 500 mg of avibactam. Patients randomized to receive CAZ-AVI will receive an infusion of CAZ-AVI (2000 mg ceftazidime and 500 mg avibactam) every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 120 minutes
16173024|NCT01599806|Drug|Doripenem|500 mg of Doripenem. Patients randomized to receive Doripenem will receive an infusion of Doripenem 500 mg every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 60 minutes
16173025|NCT01599806|Drug|Either switch to oral therapy: 500 mg of Ciprofloxacin (oral)|Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement
16173026|NCT01599806|Drug|or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral)|Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement
16173027|NCT01599793|Drug|cabozantinib|Given PO
16173028|NCT01599793|Other|laboratory biomarker analysis|Correlative studies
16173029|NCT01599793|Procedure|magnetic resonance imaging|Undergo MRI
16173030|NCT01599767|Device|Transcranial direct current stimulation (tDCS)|Subjects will undergo 15 sessions of tDCS stimulation (either active or sham), 1x per day at 20 minutes per session.
16173031|NCT01599754|Drug|Axitinib|Axitinib 5 mg twice daily
16173032|NCT01599754|Drug|Placebo|Placebo twice daily
16173033|NCT01599741|Radiation|Low-dose DSA (83% reduction compared to normal dose) with novel X-ray imaging technology.|Digital Subtraction Angiography (DSA) of iliac artery with reduced dose settings (83% dose reduction expected) in combination with novel X-ray imaging technology.
16173034|NCT01599741|Radiation|Normal dose DSA with conventional X-ray imaging technology|Digital Subtraction Angiography (DSA) of iliac artery with normal dose settings in combination with conventional X-ray imaging technology.
16173035|NCT01599728|Drug|Urocortin 2, Urocortin 3 and Substance P|"After a 20-min infusion of intra-arterial saline, ascending doses of Urocortin 2 (3.6, 12 and 36 pmol/min [15, 50 and 150 ng/min] to achieve estimated end-organ concentrations of 0.6, 2 and 6 µg/L, respectively), Urocortin 3 1200, 3600 and 12000 pmol/min (5, 15 and 50 micrograms/min) [to achieve estimated end-organ concentrations of 199, 600 and 2000 micrograms/L respectively] and substance P (a control endothelium-dependent vasodilator that evokes endogenous t-PA release [2, 4 and 8 pmol/min]) will be administered intra-arterially.
~Baseline blood samples will be taken at the start of the study for full blood count, cholesterol, glucose, renal function Bilateral venous blood samples will be taken at baseline, immediately before the start of Ucn2/Ucn3 infusion and at the end of each dose of Ucn2/Ucn3 for subsequent measurement of plasma Ucn 2 and 3 concentrations and other hormones."
16173036|NCT01599715|Behavioral|Instructional DVD|Participants randomized to this arm watched an eighteen minute bladder health instructional DVD at the conclusion of a successful baseline screening visit. This intervention occurred only once.
16173037|NCT01599715|Behavioral|Bladder Health Class|Participants randomized to this arm attended a two-hour bladder health instruction session that reviewed 3 primary self-care techniques that have been proven to prevent or lessen the severity of urinary incontinence. This session occurred only once 1-3 weeks subsequent to a successful baseline screening visit.
16173038|NCT01599702|Drug|Iron Isomaltoside 1000|1500-3000mg IV depending on HB level, sex and body weight
16173039|NCT01599689|Other|Mirrors Intervention|"Coaching in the use of two types of mirrors to support mental status and attention, physical mobility, and sense of body awareness and ownership, as well as patient dignity and privacy in self-care.
~To be administered at set times and in a standardised way by ICU nursing and physical therapy teams."
16173040|NCT01599676|Dietary Supplement|Citrulline|The subject will receive citrulline 10 g/day orally in the morning for 12 weeks.
16173041|NCT01599676|Dietary Supplement|Non essential amino acid|Non essential amino acid supplementation
16173042|NCT01599663|Other|Pain management algorithm|The algorithm guide the clinicians to score ICU patients pain systematically with different pain assessment tools. The tools are the Numeric Rating Scale, Behavioral Pain Scale and Behavioral Pain Scale Non Intubated. The algorithm guide the clinicians to choose between the different pain assessment tools depending on the ICU patient's condition and ability to rate his own pain. Thereafter the algorithm guide the clinicians to treat pain depending on the pain intensity score.
16173043|NCT01599650|Drug|Ranibizumab|
16173044|NCT01599650|Procedure|Laser|laser photocoagulation
16173045|NCT01599637|Drug|IGE025|Study medication will be supplied as a lyophilized, sterile powder in a single-use, 5-mL vial.
16173046|NCT01599637|Drug|placebo|Study medication will be supplied as a lyophilized, sterile powder in a single-use, 5-mL vial.
16173047|NCT01599624|Behavioral|Stress Resilience Training System (SRTS)|SRTS training provides both cognitive learning and training in a scientifically-designed stress resilience training approach designed to minimize the adverse effects of stress and also enhance its positive effects. In summary, the SRTS training comprises: (1) Cognitive rules and mental exercises based on expert knowledge and research; (2) Biofeedback stress control exercises based on proven HRV (Heart Rate Variability) algorithms developed by the Institute of HeartMath; and (3) E-Learning presentation of games and simulations to motivate younger trainees. The training is designed to familiarize participants with the iPad and the SRTS program. Participants will be told how to use the system and how often to use the system. SRTS program participants will each be assigned an iPad to take home with them and practice the techniques for a period of two months.
16173048|NCT01599624|Behavioral|Progressive Muscle Relaxation (PMR)|Progressive muscle relaxation is the systematic tensing and relaxing of 16 different muscle groups, starting with one's toes and ending with one's head (Jacobson, 1938; Conrad & Roth, 2007). PMR users are instructed to inhale as they tense the muscles and exhale as they release the tension. Participants will participate in a two-hour PMR training. PMR participants will be given iPADs with a video recording that guides the user through working each muscle group while instructing them to focus on positive thoughts and feelings and breathing techniques. PMR program participants will each be assigned an iPad to take home with them and practice the techniques for a period of two months.
16173049|NCT01599611|Procedure|Movement assessment battery for children - 2|A standardised test developed to identify developmental difficulties in children.
16173101|NCT01599104|Drug|Placebo|Placebo to LCZ696 or Olmesartan
16173183|NCT01598376|Procedure|5/0 vicryl test suture|5/0 vicryl test suture placed as one of 3 everting sutures
16173050|NCT01599598|Behavioral|Progressive Muscle Relaxation|Participants will be instructed to practice the techniques twice daily for 5-15 minutes per session, and subsequently use the techniques when confronted with a stressful event such as a project deadline, exam, skill evaluation, etc. Participants in this condition will listen to PMR instruction by way of a mp3 player.
16173051|NCT01599598|Behavioral|Coherence Advantage|Participants will be instructed to practice the techniques twice daily for 5-15 minutes per session, and subsequently use the techniques when confronted with a stressful event such as a project deadline, exam, skill evaluation, etc. Participants in this condition will practice the techniques while using a biofeedback device to recognize when they enter psychophysiological coherence.
16173052|NCT01599585|Behavioral|Behavioral Activation|Behavioral activation(BA)will be delivered in 8 weekly sessions via webcam for the in-home arm or face to face in the in-person arm. Behavioral activation attempts to help depressed individuals reengage in their lives through focused activation strategies.
16173053|NCT01599572|Other|zinc supplementation|30mg/day of zinc in the form of zinc gluconate
16173054|NCT01599559|Other|observation|observation
16173055|NCT01599559|Radiation|3D-Conformal Radiotherapy (3D-CRT)|Radiation treatment should start within 6-8 weeks after the end of chemotherapy.
16173056|NCT01599533|Other|blood samples|
16173057|NCT01599520|Behavioral|Spanish-Language Self-Administered Training Plus Usual Care (SL-SAT)|"Patients will receive usual care. In addition, a Spanish-speaking intervention associate will spend an extra 10 minutes on the day usual care is initiated reviewing the self-administered training materials in Spanish titled Cómo tratar el estrés durante la quimioterapia. Materials consist of an 18-minute DVD (also available as a videocassette (VC)), a 28-minute CD (also available as an audiocassette (AC)), a 16-page booklet, and a workbook to record practice and use of stress management techniques. Participants are instructed to first view the DVD/VC and then follow directions in the booklet and on the CD/AC about training, practice, and use of stress management techniques."
16173058|NCT01599520|Behavioral|Usual Care Only|"Patients will be given the Spanish-language version of Chemotherapy and You: Support for People with Cancer (La quimioterapia y usted: Apoyo para las personas con cancer) published by NCI. The intervention associate will review how it provides answers to common questions about chemotherapy, describes common side effects and their management, and identifies ways to obtain additional information. Patients will also be provided with a list of local support groups for cancer patients and informed that a social worker is available to meet with them without charge to discuss personal concerns or practical problems. At the first infusion, oncology nurses will provide all patients with standard education about the chemotherapy agents and anti-emetic agents to be administered, possible adverse reactions to these agents, and recommended precautions for avoiding illness and maintaining health."
16173059|NCT01599507|Drug|FG-4592|TIW dosing, capsule
16173060|NCT01599507|Drug|Placebo|TIW dosing, capsule
16173061|NCT01599494|Drug|MK-8962|"MK-8962 is supplied in a ready-to-use prefilled syringe containing
~100 microgram (μg) or 150 μg corifollitropin alfa per 0.5 mL. Participants are randomized to receive a single subcutaneous (SC) injection of MK-8962 in the abdominal wall on Cycle Day 2 or Cycle Day 3. Dose of administered MK-8962 is weight-based. Participants who weigh 60 kilograms (kg) or less will be given 100 μg MK-8962 and those who weigh more than 60 kg will be given 150 μg MK-8962."
16173062|NCT01599494|Drug|recFSH|Recombinant Follicle Stimulating Hormone (recFSH) will be supplied as a ready-to-use solution in a 600 IU cartridge for SC injection via the recFSH Pen. Starting on Day 2 or 3 of the menstrual cycle (Stimulation Day 1), recFSH will be administered daily, each morning, via injections in the abdominal wall. A starting dose of between 150 - 300 IU will be administered and is fixed for the first week of stimulation. After 6 days, and based on each participant's individual response, the Investigator may decide to reduce the fixed dose for the remainder of the study. The maximum duration of stimulation is 19 days; recFSH will not be administered on the Day of hCG Administration.
16173063|NCT01599494|Drug|Ganirelix|0.25 mg/day SC injection in the upper leg, administered on Stimulation Day 5 up to and including Day of hCG Administration
16173064|NCT01599494|Drug|human Chorionic Gonadotropin (hCG)|Single dose of 10,000 or 5,000 IU hCG, administered via SC injection on Day of hCG Administration.
16173065|NCT01599494|Drug|Progesterone|Crinone 8% (90 mg) gel administered intravaginally via a single-use, one piece polyethylene vaginal applicator once-daily on Day of Oocyte Pick-up or 1 day later and continued for at least 6 weeks or either up to menses or up to a negative pregnancy test performed at least 18 days after Day of Oocyte Pick-up.
16173066|NCT01599481|Behavioral|Individual Career Management (ICM)|The intervention will be Individual Career Management (ICM) support for a six month period. ICM consists of individually tailored support to help an individual to obtain and retain in employment. ICM follows the seven principles of supported employment (often referred to an Individual Placement and Support), but includes the additional principles of career counselling, motivational coaching, education and training support, and specialist job retention support. The length and frequency of ICM support sessions is determined by the needs of the client.
16173067|NCT01599481|Behavioral|Standard Care|A package of psychological therapy delivered by an Improving Access to Psychological Therapies (IAPT) practitioner.
16173068|NCT01599468|Drug|Tranexamic Acid|10 mg/kg of tranexamic acid as induction dose within 12 minutes and 1mg/Kg/h as maintenance within the 2 following hours
16173069|NCT01599468|Drug|saline serum|The Placebo group received normal saline with the same volumes
16173070|NCT01599416|Dietary Supplement|U-relax|Oral U-relax Day 1-5: 2 capsuals before sleep Day 6-360: 1 capsual before sleep
16173071|NCT01599403|Procedure|Paravertebral Block|The paravertebral block consists of injection of local anesthetics into the area next to the spinal column and results in regional pain control. This technique of this block may be performed on multiple levels if there are extensive rib fractures and may be performed on both sides of the rib cage depending on injury.
16173072|NCT01599403|Procedure|Intercostal Nerve Block|The intercostal nerve block will consist of placing a catheter which delivers pain medication into the area between the ribs. This technique of this block may be performed on multiple levels if there are extensive rib fractures and may be performed on both sides of the rib cage depending on injury.
16173073|NCT01599403|Procedure|Epidural Block|The epidural block consists of continuous infusion of local anesthetics into the epidural catheter placed into the epidural space (next to the spinal column) and results in regional pain control. This technique of this block may be performed at the appropriate level so the pain of rib fracture may be better controlled.
16173074|NCT01599390|Other|Data collection|"The study will use multiple primary data sources: the Nationwide Inpatient Sample (for hospitalisations) and the US National Vital Statistics System (for mortality), and weekly virology data from the Centers for Disease Control and Prevention (CDC) influenza surveillance program supplemented with literature data.
~Weekly time series of the rates of various severe influenza-related health outcomes will be constructed. Statistical models, guided by weekly numbers of cases of laboratory-confirmed influenza and respiratory syncytial virus (RSV) contained in the CDC virology data, will be constructed to estimate the portions of the various outcomes that can be attributed to influenza. Next, the seasonal impact of influenza by age, risk status, and influenza subtype will be assessed. Finally, the potential burden that a quadrivalent vaccine could have prevented over the 12 year study period will be predicted."
16173075|NCT01599377|Drug|tofacitinib 10 mg|Cohort 1 will consist of 2 periods and 2 sequences. Subjects will be randomized to one of the 2 sequences. In sequence 1, subjects will receive a 10 mg tofacitnib tablet under fasting conditions in period 1, followed by a 10 mg tofacitinib capsule in fasting conditions in period 2. In sequence 2, the treatments will be reversed for period 1 and 2.
16173076|NCT01599377|Drug|tofacitinib 5 mg|Cohort 2 will consist of 2 periods and 2 sequences. A total of 24 healthy subjects will be enrolled for this cohort. Subjects will be randomized to one of the 2 sequences. In sequence 1, subjects will receive a 5 mg tablet under fasting conditions in period 1, followed by a 5 mg capsule in fasting conditions in period 2. In sequence 2, the treatments will be reversed for period 1 and 2.
16173077|NCT01599364|Drug|Atazanavir, ritonavir, lamivudine|Lamivudine 300 mg 1 pill once-a-day, atazanavir 300 mg 1 pill with ritonavir 100 mg 1 pill once-a-day, taken together orally with a light meal
16173078|NCT01599351|Radiation|The radiographic-fluoroscopic system|Fluoroscopy was used during ERCP procedure. With automatic brightness adjustment, patients with thicker body will get greater radiation dose.
16173079|NCT01599338|Drug|Liraglutide|3 months of treatment by Liraglutide (self-administration). The initial dose was 0.6 mg/day subcutaneously during five days, then uptitrated to a daily dose of 1.2 mg during three months.
16173080|NCT01599325|Drug|Azacitidine|Subcutaneous administration of azacitidine 75 mg/m^2/day for 7 days every 28 days optimally for at least 6 cycles until disease progression, unacceptable toxicity, or treatment discontinuation for any other reason
16173081|NCT01599312|Device|Forces exerted on teeth during intubation|Anesthesia will be induced in the conventional matter. The classic Macintosh laryngoscope will be placed in the patient's mouth and a tube will be brought into position in front of the glottis. Hereafter, one of the three videolaryngoscopes will be placed in the patient's mouth and the endotracheal tube will be actually passed through the vocal cords. The measurement of forces applied to the teeth will be performed using Flexiforce® sensors.
16173082|NCT01599286|Drug|Carbaglu|"Carbaglu Chemical Composition: N-carbamoyl-L-glutamic acid (NCG)
~The daily dose will be 150 mg/kg/ day or 3.3 g/m2/day for patients >15 kg and will be administered for 7 days or until discharge, whichever is sooner. The doses are to be divided into 2 equal doses and administered orally or enterally by nasogastric or gastrostomy tube. Standard of care will prevail when choosing the mode of drug administration.
~The tablets must be dispersed in a minimum of 2.5-10 ml of water and ingested immediately or administered by fast-push through a syringe via a nasogastric or gastrostomy tube. The suspension has a slightly acidic taste."
16173083|NCT01599286|Drug|Placebo|Placebo that looks/tastes the same as NCG and is administered on the same schedule as the NCG intervention
16173084|NCT01599273|Drug|subconjunctival triamcinolone injection|Patients are randomized into two groups: Injection (Group 1) and observation-only controls (Group II). In Group I, patients were treated with 1-3 injections of 20 mg triamcinolone acetate using a 30-gauge needle into the subconjunctival region of the lid between the conjunctiva and Muller's muscle. Injections were stopped after 1-2 injections if both swelling and retraction resolved completely, or if one eye scored 0 and the contralateral eye scored 1, and there existed no patient concern after physician inquiry regarding function and cosmetic appearance.
16173085|NCT01599260|Other|Resistance Exercise|Two 30-minute individually supervised exercise sessions per week for 16-weeks
16173086|NCT01599234|Drug|Sativex|Contains delta-9-tetrahydrocannabinol (THC) (27mg/ml): cannabidiol (CBD) (25 mg/ml), in ethanol:propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Maximum permitted dose was eight actuations in any three hour period and 24 actuations (THC 65 mg:CBD 60 mg) in 24 hours.
16173087|NCT01599234|Drug|Placebo|Contains peppermint oil flavouring, 0.05%(v/v); quinoline yellow,0.005% (w/v) and sunset yellow, 0.0025% (w/v) colourants, in a and ethanol:propylene glycol (50:50) excipient.
16173088|NCT01599221|Device|EBA2|Surgical implantation of EBA2 medical device in subjects with lateral proximal femoral fractures treated
16173089|NCT01599208|Device|TMS|TRANSCRANIAL MAGNETIC STIMULATION
16173090|NCT01599195|Device|AudioDoc|AudioDoc will be used to identify the carotid and femoral bruit
16173091|NCT01599169|Dietary Supplement|Dietary supplement : B-Back® (α-casozepine, taurine, eleutherococcus senticosus, Extramel)|2 tablets/day after breakfast during 12 weeks
16173092|NCT01599169|Dietary Supplement|B-Back® placebo (without active compounds)|2 tablets/day after breakfast during 12 weeks
16173093|NCT01599156|Procedure|Reflexology|Reflexology is a therapy whereby diagnosis and treatment are done on the patient's feet. According to reflexology, our feet are a micro-cosmos of our bodies and contain all the body's systems and internal organs. The treatment is palpation and massage of specific reflex points that respond to the body organs. This massage or palpitation of reflex points improves the physical function of the corresponding organ or system
16173094|NCT01599143|Behavioral|Teaching Mindfulness-based Stress Reduction strategies|Daily meditation, Hatha yoga,and cognitive restructuring
16173095|NCT01599130|Drug|Entecavir|entecavir 0.5mg per day
16173096|NCT01599130|Drug|Peginterferon alfa-2a|Peginterferon alfa-2a 180ug per week
16173097|NCT01599117|Drug|Placebo|Capsule, appears identical with udenafil, will be provided by Dong-A pharmaceutical company. Patients will receive 50 mg of placebo drug two times a day for 4 weeks, and then the dosage will be escalated to 100 mg two times a day for next 8 weeks.
16173098|NCT01599117|Drug|Udenafil (Zydena)|Udenafil (Zydena), a newly developed PDE-5 inhibitor by Dong-A pharmaceutical company, will be administered to patients in this group, 50 mg two times a day for 4 weeks, and then the dosage will be escalated to 100 mg two times a day for next 8 weeks.
16173099|NCT01599104|Drug|LCZ696|200 mg (one tablet) or 400 mg (2 tablets of 200mg) once daily
16173102|NCT01599091|Other|Specimens collection|Tooth extraction will be preformed in the regular way regardless of the study. Patients will be asked permission to obtain the extracted tooth and excess of gingival remnants for further in vitro investigation in the main investigator's laboratory.
16173103|NCT01599078|Drug|Paclitaxel|Drug dosing is 3mcg/mm3 of artery treated with percutaneous revascularization. Drug will be administered via the TAPAS catheter and allowed to dwell for 5 minutes.
16173104|NCT01599078|Drug|Placebo|Saline will be administered intra-arterially via the TAPAS catheter following percutaneous revascularization. The dwell time will be 5minutes.
16173105|NCT01599065|Other|Magnet or Off-On|Randomized to ICD suspension using a magnet or turning the ICD off and then back on.
16173106|NCT01599013|Drug|Vinflunine, Gemcitabine|"Vinflunine 280 or 250 mg/m2, IV administration over 20 minutes (starting dose based on baseline creatinine clearance value), Day 1 every 3 weeks up to progression or unacceptable toxicity or patient's refusal
~Gemcitabine 750 or 1000 mg/m2, IV administration over 30 minutes (starting dose based on baseline creatinine clearance value), Day 1 and 8 every 3 weeks up to progression or unacceptable toxicity or patient's refusal"
16173107|NCT01599013|Drug|Vinflunine, Carboplatin|"Vinflunine 280 or 250 mg/m2, IV administration over 20 minutes (starting dose based on baseline creatinine clearance value), Day 1 every 3 weeks up to progression or unacceptable toxicity or patient's refusal
~Carboplatin AUC 4.5, IV administration over 60 minutes, Day 1 every 3 weeks up to progression or unacceptable toxicity or patient's refusal"
16173108|NCT01599000|Drug|Artemether-lumefantrine combination|fixed-dose tablet, six doses over three days, according to weight group
16173109|NCT01598987|Drug|Introduction of everolimus with reduced cyclosporine or tacrolimus dose, the earliest 1 month and the latest 6 months after liver transplantation.|Immunosuppression after liver transplantation. Pediatric transplant recipients received a starting dose of 0.8 mg/m^2/dose in combination wit Cyclosporine A or 2.0 mg/m^2/dose in combination with tacrolimus, twice-daily. Thereafter, doses were adjusted to achieve everolimus C-0h blood trough level between 3 to 8 ng/ml.
16173110|NCT01598974|Procedure|Traditional Acupuncture|
16173111|NCT01598974|Procedure|Laser Acupuncture|
16173112|NCT01598961|Other|TOF count-guided partial NMB|Using partial neuromuscular blockade to maintain train-of-four response of two, TOF response measured by the neuromuscular transmission module (NMT module)
16173113|NCT01598961|Other|T1/Tc guided partial NMB|Using partial neuromuscular blockade to maintain T1/Tc amplitude of 50%, T1/Tc amplitude measured by the neuromuscular transmission module (NMT)
16173114|NCT01598961|Other|No NMB|to maintain no neuromuscular blockade during LSR monitoring except the intubation dose during anesthetic induction
16173115|NCT01598948|Drug|mipomersen|mipomersen 200 mg subcutaneously every week for 37 weeks (phase 1: 26 weeks; phase 2: 11 weeks)
16173116|NCT01598935|Other|nutrition|protein-based food
16173117|NCT01598922|Behavioral|Internet Cognitive Behavioral Therapy|8 weeks of online treatment program
16173118|NCT01598909|Drug|Arnica|Application of Arnica ointment periorbitally
16173119|NCT01598909|Drug|Placebo ointment|Application of Arnica ointment, twice a day, for the period of one week.
16173120|NCT01598896|Drug|Dronabinol|Dronabinol titrated to 5 mg three times daily
16173121|NCT01598896|Drug|Clonidine|Clonidine 0.1 mg twice daily
16173122|NCT01598896|Drug|Placebo|One placebo capsule by mouth twice daily
16173123|NCT01598883|Drug|Heparin|150 U/kg
16173124|NCT01598883|Drug|ATryn|1000 IU
16173125|NCT01598870|Other|Diagnostic tests|Leukocyte count by automated counters; reagent strips for leukocyte esterase and for lactoferrin; ascitic fluid pH; leukocyte cytometry; bacterial DNA detection and quantification.
16173126|NCT01598857|Drug|Blisibimod|
16173127|NCT01598857|Drug|Placebo|
16173128|NCT01598844|Device|Transcatheter aortic valve replacement|Transcatheter aortic valve replacement via a transapical access
16173129|NCT01598831|Drug|ART-123|Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days
16173130|NCT01598831|Drug|Placebo|Dose: 0.06 mg/kg/day up to a maximum dose of 6 mg/day for 6 days.
16173131|NCT01598805|Behavioral|electronic alerts|An eAlert is displayed in the electronic patient chart if no prophylaxis has been ordered within 6 h after admission or transfer.
16173132|NCT01598792|Biological|ADXS11-001|Escalating doses will be administered: 3.3 x 10e8,1 x 10e9 and 3.3 x 10e9 cfu to patient in 3 different groups. Dose-escalation will only occur if fewer than two patients in each group of six experience Dose Limiting Toxicity (DLT).
16173133|NCT01598766|Device|16 Channel SPEEDER Flex Coil|This is a 16 element MRI coil, flexible, lightweight. Multiple uses.
16173134|NCT01598753|Drug|Tramadol|"50 mg tablets titrated up to 2 tablets four times per day for a maximum dose of 400mg per day.
~Minimum accepted dose of 200mg per day"
16173135|NCT01598753|Drug|Placebo|Pharmacological inactive tablet, 50mg tablets titrated to 2 tabs per day up to 400mg
16173136|NCT01598753|Behavioral|Cognitive Behavior Therapy for FM|Subjects will be seen for 8 weekly 50 minute sessions of Cognitive Behavior Therapy that has been specifically tailored for Fibromyalgia patients.
16173137|NCT01598753|Behavioral|Health Education|Subjects will receive 8 weekly 50 minute sessions of Health Education on Fibromyalgia
16173138|NCT01598740|Drug|CLP|Oral administration
16173139|NCT01598740|Drug|Spironolactone|oral administration
16173140|NCT01598727|Device|Fluobeam(TM) Imaging System (Fluoptics)|Use of 'Fluobeam(TM)' (Fluoptics) as an intraoperative real time fluorescence detection system during surgery
16173141|NCT01598714|Device|Darco shoe|Darco shoe
16173142|NCT01598714|Device|Podalux shoe|Podalux shoe
16173143|NCT01598714|Device|Standard dressing shoe|Standard dressing shoe
16173144|NCT01598701|Drug|Acetaminophen|Intravenous Acetaminophen, 1000 mg/100mL, Every 6 hours, Infused over 15 minutes.
16173145|NCT01598701|Drug|Placebo|100 mL 0.9% Sodium Chloride
16173181|NCT01598389|Other|Feeding study|In a crossover design, siblings were served dinner once a week for 3 weeks. Across conditions, siblings were served the same dinner, but, 25 minutes before dinner, they either consumed in full or did not consume one of two preloads that varied in energy density. On the day when no preload was consumed, eating in the absence of hunger was assessed after dinner and defined as the number of calories consumed from snacks. Habitual dietary intake was assessed using 24-hour dietary recalls.
16173184|NCT01598363|Drug|Digoxin|Oral, Day 1 and Day 10
16173146|NCT01598688|Other|Blood collection immediately after interrupting CSA infusion|"Blood samples were collected from the peripheral venous access, from the catheter line used to infuse the drug and from the line not used for infusion immediately after interrupting the drug infusion.
~For peripheral blood collection, venous access will be established with a small gauge needle.
~The discard method will be adopted for catheter lines collection. Each catheter line is washed with 20 ml of 0.9% normal saline solution, 5 mL of blood are collected and discarded. Using another syringe, the blood volume needed to perform the analysis will then be collected. Additionally, another blood sample will be collected from the catheter line not used to infuse the drug after the discard of 10 mL."
16173147|NCT01598688|Other|Blood collection five minutes after interrupting CSA infusion|"Blood samples were collected from the peripheral venous access, from the catheter line used to infuse the drug and from the line not used for infusion five minutes after interrupting the drug infusion.
~For peripheral blood collection, venous access will be established with a small gauge needle.
~The discard method will be adopted for catheter lines collection. Each catheter line is washed with 20 ml of 0.9% normal saline solution, 5 mL of blood are collected and discarded. Using another syringe, the blood volume needed to perform the analysis will then be collected. Additionally, another blood sample will be collected from the catheter line not used to infuse the drug after the discard of 10 mL."
16173148|NCT01598675|Other|Same Belt Speeds|18 sessions of training (3X/week). 20 minutes/session on treadmill; 10 minutes/session overground 70-75%HRmax. Control-Dual-belted treadmill belts respond to encourage symmetric gait
16173149|NCT01598675|Other|Different Belt Speeds|18 sessions of training (3X/week). 20 minutes/session on treadmill; 10 minutes/session overground 70-75%HRmax. Treadmill belts of dual-belted treadmill respond either to amplify asymmetric gait or encourage symmetric gait.
16173150|NCT01598662|Device|Mirena (levonorgestrel-releasing intrauterine system)|The Mirena IUD is a levonorgestrel-releasing IUD which contains 52 mg levonorgestrel total and releases 20 mcg of hormone daily.
16173151|NCT01598649|Dietary Supplement|Fabricated foods with lupin protein|- Foods containing altogether 25 g lupin protein isolate (bread, roll, sausage, spread)
16173152|NCT01598649|Dietary Supplement|Mannitol|- Placebo capsules containing mannitol (four capsules per day)
16173153|NCT01598649|Dietary Supplement|Arginine|- Capsules containing arginine (four capsules per day with a total daily dosage of 1,6 g)
16173154|NCT01598649|Dietary Supplement|Fabricated foods with milk protein|Foods containing altogether 25 g milk protein isolate (bread, roll, sausage, spread)
16173155|NCT01598636|Procedure|Lateral tibial tunnel|To reduce the rehabilitation time after ACL revision surgery due to a better surgical technique
16173156|NCT01598623|Drug|Oxytocin|24 IU Intranasal, three times daily (morning, noon and evening, before meals) for 3 weeks (21 days).
16173157|NCT01598623|Behavioral|Social Skills Training|three times a week for three weeks.
16173158|NCT01598623|Behavioral|Placebo + Non Specific Counselling|
16173159|NCT01598610|Device|CONTOUR® PLUS Investigational BG Monitoring System|Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the CONTOUR® PLUS Investigational BG Monitoring System. Study staff test subject venous blood. All Blood Glucose (BG) results are compared to a reference laboratory glucose method.
16173160|NCT01598584|Drug|Mirtazapine plus gemcitabine|Mirtazapine,15mg/day for 3 days, If patients is durable, the dosage increase to 30mg/day, if the patient is durable, the doctor then will decided whether to increase to 45mg. Gemcitabine 1000mg/M2,d1,d8,q3w
16173161|NCT01598584|Drug|Gemcitabine, placebo|Gemcitabine 1.0g/m2,d1,d8,q3w placebo
16173162|NCT01598571|Drug|Fostamatinib|Fostamatinib 50 mg tablet
16173163|NCT01598571|Drug|Fostamatinib|Fostamatinib 100 μg [14C] R406 intravenous micro tracer dose
16173164|NCT01598558|Drug|Cu-64 Rituximab|Up to 14 mCi, iv
16173165|NCT01598545|Drug|Hydromorphone|Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.
16173166|NCT01598532|Device|MedX Health Phototherapy (light therapy)|The treatment period is 6 weeks (3x per week) for a total of 18 Transcranial LED treatments. Each treatment session is 30 minutes each.
16173167|NCT01598519|Behavioral|suicide intervention|"universal intervention:(1)students: 4 sections about cherishing life, coping strategies, suicide and depression disorder during 2 semesters, each session lasting 45 minutes.(2)gatekeeper: 4 sessions about teenagers psychological crisis intervention strategies during 2 semesters, 30minutes per session.
~indicated intervention: (1)student: 2 semesters, 20 sessions' group life skill and cognitive-behavioral psychological training lesson, including Youth rational emotive group tutoring(eight classroom sessions), Coping skill group tutoring(six classroom sessions)and Behavior group tutoring(six classroom sessions), once a week, each session lasting 1.5hours.(2)gatekeeper: a social support net."
16173168|NCT01598506|Drug|Hydromorphone|Hydromorphone will be administered one time intrathecally to laboring patients to determine the ED50 for pain relief.
16173169|NCT01598493|Device|BCT Antimicrobial Dressing|Activated carbon fiber impregnated with silver particles
16173170|NCT01598493|Drug|Flamazine|Silver sulfadiazine cream
16173171|NCT01598480|Drug|Flamazine|Silver sulfadiazine cream
16173172|NCT01598480|Device|BCT Antimicrobial Dressing|Activated carbon fiber impregnated with silver particles
16173173|NCT01598467|Procedure|Robotic assisted sacrocolpopexy (RASC)|Robotic assisted sacrocolpopexy (RASC) will be performed with the Da Vinci Surgical robot (Intuitive Surgical). THe mesh used will be a Type I (Amid classification), polypropylene mesh
16173174|NCT01598454|Drug|racotumomab|Dosage form: intradermal injection. Dosage: 0.15 mg; 0.25 mg; 0.4 mg. Frequency: 3 biweekly injections or 6 biweekly injections. Duration: 4 weeks or 10 weeks.
16173175|NCT01598441|Drug|iloprost nebuliser solution|Iloprost nebuliser solution 500 ng/kg inhaled(10 min recommended) q3h for 2 days
16173176|NCT01598441|Drug|distilled water|1-2 ml aerosolized distilled water inhalation per session
16173177|NCT01598428|Procedure|anterior capsule polishing|polish the anterior capsule and the equator of capsule extensively with a Whitman Shepherd Double-Ended Capsule Polisher
16173178|NCT01598415|Drug|SAR113945|"Pharmaceutical form:Injection
~Route of administration: Intra-articular"
16173179|NCT01598415|Drug|placebo|"Pharmaceutical form:Injection
~Route of administration: Intra-articular"
16173180|NCT01598402|Drug|amoxicillin/clavulanic acid suspension|625 mg tid, start day 29 after the start of CRT until 14 days after the end of CRT
16173186|NCT01598350|Device|Supramalleolar Orthoses (Cascade)|Walk wearing supramalleolar orthoses - three trial
16173187|NCT01598337|Drug|Aspirin|Patients continue their maintenance dose not inturrupted by surgery , 81 mg daily
16173188|NCT01598337|Drug|Tirofiban|Tirofiban infusion as specified by investigators to start after hemostasis been established
16173189|NCT01598337|Drug|Clopidogrel|75 mg orally started 6-8hours before surgery
16173190|NCT01598337|Drug|Prasugrel|10 mg daily as per instructions of investigators
16173191|NCT01598311|Drug|CB-183,315|CB-183,315 250 mg white coated tablet over-encapsulated in a size 00 opaque hard gelatin capsule.
16173192|NCT01598311|Drug|Vancomycin|Vancomycin hydrochloride 125 mg capsule over-encapsulated in size 00 opaque hard gelatin capsule.
16173193|NCT01598311|Drug|Placebo|Placebo size 00 opaque hard gelatin capsules.
16173194|NCT01598298|Drug|duloxetine hydrochloride|Given PO
16173195|NCT01598298|Other|placebo|Given PO
16173196|NCT01598272|Dietary Supplement|Vitality product AM + Vitality product PM|Vitality AM: Tak 6 capsules daily for 56 days Vitality PM: Take 2 capsules daily for 56 days
16173197|NCT01598272|Dietary Supplement|Placebo|Placebo AM: Take 6 capsules daily for 56 days Placebo PM: Take 2 capsules daily for 56 days
16173198|NCT01598259|Drug|Melatonin|po 1 hour before bedtime
16173199|NCT01598259|Other|placebo|po, 1 hour before bed
16173200|NCT01598233|Device|Silimed Intragastric balloon|Intragastric balloon inflated with 650 ml of NaCl 0.9% mixed with 20 ml of methylene blue solution
16173201|NCT01598220|Behavioral|Computer-assisted cognitive remediation therapy|"Comparison of two groups:
~The experimental group performs 48 sessions of computer exercices designed to remedy cognitive domains(attention, speed of processing, working memory,reasoning and problem solving) frequently affected in schizophrenia.
~The intervention has a period 6 months , two sessions a week. All exercises provided a visual or verbal feedback to immediately terminate the execution.In addition to, the therapist after the sessions interactively explain the results and the strategies employed by the patient."
16173202|NCT01598220|Other|attentional task|The Control group performs 48 sessions of watching videos and answer questions about these videos, in a period of 6 months , two sessions a week.
16173203|NCT01598207|Drug|Marinol|5mg BID, orally for 1 month
16173204|NCT01598207|Drug|Placebo|5mg BID, orally for 1 month
16173205|NCT01598194|Device|Novel 22-gauge Core Biopsy Needle + Standard Biopsy Needle|Two passes performed with the standard 22-gauge or 25-gauge straight hollow core needle and two passes will be performed using the 22-gauge EchoTip® Procore™ needle. All passes will be taken from a single lesion and from the same endoscopic location.
16173206|NCT01598181|Device|tDCS NeuroConn DC-stimulator plus|Anodal tDCS, M1, cathode supraorbital left, 2 mA, 20 min, 5 consecutive days.
16173207|NCT01598181|Device|sham tDCS|similar montage and time as active. Stimulation fades out after 20 sec.
16173208|NCT01598168|Drug|Rivaroxaban|Rivaroxaban 15 mg bid until HIT excluded by local laboratory assay or platelets recovered. If HIT positive and platelets have recovered, patients will receive rivaroxaban 20 mg od until Day 30.
16173209|NCT01598155|Procedure|Group 1 - Supragingival biofilm control|"30 days after the end of periodontal treatment, participants assigned to this group, will receive every 3 months (over 24 months):
~Scaling, planning and polishing coronary surface;
~Education and motivation for oral hygiene and daily supragingival biofilm control by the patient."
16173210|NCT01598155|Procedure|Group 2 - Supra- and subgingival biofilm control|"30 days after the end of periodontal treatment, participants assigned to this group, will receive every 3 months (over 24 months):
~Scaling, planning and polishing of coronary surface;
~Education and motivation for oral hygiene and daily supragingival biofilm control by the patient;
~Subgingival scaling and root planning in sites with persistent bleeding on probing and probing depth unchanged."
16173211|NCT01598142|Procedure|Team 1|experienced endoscopist with a experienced assistant
16173212|NCT01598142|Procedure|Team 2|same experienced endoscopist with a new trained assistant
16173213|NCT01598129|Genetic|ONCOS-102|GMCSF encoding 3/5 chimeric adenovirus for intratumoral and intravenous injection on day 1, 4, 8, 15, 29, 57, 85, 113 and 141 tested in three different dose cohorts (3x10E10, 1x10E11 and 3x10E11) in combination with low-dose metronomic cyclophosphamide.
16173214|NCT01598116|Procedure|Urine collection and ultrasonography|Bagged urine collection and ultrasound at each visit
16173215|NCT01598116|Procedure|Urine collection|Bagged urine collection
16173216|NCT01598103|Drug|SAF312|One week of treatment in a BID (two times a day) regimen (hard gelatin capsules for oral use)
16173217|NCT01598103|Drug|Placebo to SAF312|One week of treatment in a BID (two times a day) regimen (hard gelatin capsules for oral use)
16173218|NCT01598090|Biological|Peginterferon Lambda-1a|Syringes, subcutaneous (SC), 180μg, Once weekly, 24 or 48 weeks depending on response
16173219|NCT01598090|Biological|Peginterferon Alfa-2a|Syringes, SC, 180μg, Once weekly, 24 or 48 weeks depending on response
16173220|NCT01598090|Drug|Ribavirin|Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 24 or 48 weeks depending on response
16173221|NCT01598090|Drug|Telaprevir|Tablets, Oral, 750 mg, three times a day, 12 weeks only
16173222|NCT01598077|Drug|LJM716|
16173223|NCT01598064|Dietary Supplement|GK#10|GK#10, 1 pack tid
16173224|NCT01598064|Drug|Placebo|Placebo 1 pack tid po
16173225|NCT01598051|Drug|Rivaroxaban (Xarelto_ BAY59-7939)|Patients treated with Xarelto under practical manner for SPAF.
16173226|NCT01598038|Other|Blood sample|Everolimus is determined in whole blood by validated high performance liquid chromatography with tandem mass spectrometry after protein precipitation
16173227|NCT01598025|Radiation|total-body irradiation (TBI)|
16173228|NCT01598025|Drug|thiotepa|
16173229|NCT01598025|Drug|fludarabine phosphate|
16173230|NCT01598025|Drug|melphalan|
16173231|NCT01598025|Biological|anti-thymocyte globulin|
16173232|NCT01598025|Procedure|allogeneic hematopoietic stem cell transplantation|
16173233|NCT01598025|Biological|peripheral blood stem cell transplantation|
16173234|NCT01598025|Other|laboratory biomarker analysis|
16173235|NCT01598012|Drug|Ayurved Siriraj Prasaplai with or without mefenamic acid|Prasaplai in capsule, 2 cap three times a day for 3 days. Mefenamic acid 500 mg prn for severe pain (as rescue medication)
16173697|NCT01594749|Drug|Fosaprepitant Placebo|
16173236|NCT01598012|Drug|Placebo with or without mefenamic acid|Placebo in capsule (physically identical appearance as Prasaplai) 2 cap three times a day for 3 days. Mefenamic acid 500 mg prn for severe pain, every 6 hours (rescue medication)
16173237|NCT01597999|Radiation|MRI|magnetic resonance imaging (MRI) with Gadovist in early breast cancer with poor prognostic features
16173238|NCT01597986|Drug|isavuconazole|oral
16173239|NCT01597986|Drug|Oral Contraceptive (ethinyl estradiol / norethindrone)|contraceptive pill consisting of ethinyl estradiol and norethindrone
16173240|NCT01597973|Drug|colistin and meropenem|colistin standard loading dose, maintenance dose based on patients renal function meropenem- dose based on patients renal function
16173241|NCT01597973|Drug|colistin and placebo|colistin- loading dose standard, maintenance dosed based on patients renal function placebo- mimic meropenem (blinded)
16173242|NCT01597960|Other|Yoga|Those randomised to usual care plus the yoga intervention will be required to attend yoga classes twice a week for 12 weeks alongside their cardiac rehabilitation programme. There will be 24 yoga classes in total, of which, we require the participant to attend a minimum of 18. The yoga classes will be conducted by a teacher certified in yoga and cardiac rehabilitation and will encompass physical fitness (yoga poses), stress reduction (breath control and meditation) and positive lifestyle changes (diet, smoking and alcohol).
16173243|NCT01597947|Drug|ACHN-975|Intravenous single dose
16173244|NCT01597947|Drug|placebo|Intravenous single dose
16173245|NCT01597934|Drug|Group A (Zeffix, Sebivo, Hepsera)|Maintaining LAM/LdT+ADV combination Lamivudine 100mg / Telbivudine 600mg +Adefovir 10mg
16173246|NCT01597934|Drug|Group B (Baraclude, Viread)|Switching to ETV plus TDF combination Entecavir 1.0mg + Tenofovir 300mg
16173247|NCT01597908|Drug|Dabrafenib|Dabrafenib 150 mg twice daily orally
16173248|NCT01597908|Drug|Vemurafenib|Vemurafenib 960 mg twice daily orally
16173249|NCT01597908|Drug|Trametinib|Trametinib 2 mg once daily orally
16173250|NCT01597895|Drug|Maraviroc|Maraviroc 150 mg BID x 5 days with food
16173251|NCT01597895|Drug|Maraviroc + Boceprevir|Maraviroc 150 mg BID + Boceprevir 800 mg TID x 10 days with food
16173252|NCT01597895|Drug|Maraviroc + Telaprevir|Maraviroc 150 mg BID + Telaprevir 800 mg TID x 10 days with food
16173253|NCT01597869|Device|Endobronchial ultrasound|EBUS-TBNA is a bronchoscopic diagnostic method that enables real time aspiration of paratracheal and peribronchial lesions.
16173254|NCT01597856|Behavioral|SBIRT|"SBIRT Therapy overview-
~Therapist explains purpose of the therapy.
~Inquiry about Compensation examination-ask if Veteran has questions about determination process and address concerns.
~Discuss relationship between PTSD and substance use- long-term substance use is a form of avoidance and barrier to recovery.
~Discuss treatment needs, administer screening, provide feedback."
16173255|NCT01597843|Other|Education|Series of training sessions, in person and on line, to educate post superusers who will in turn educate post members on the utility and mechanics of use of MHV.
16173256|NCT01597830|Other|Mobility shoe|flat, specialized shoe
16173257|NCT01597830|Other|control shoe|control shoe
16173258|NCT01597817|Other|chitosan coated textile|chitosan coated cotton long sleeved shirts and pants.
16173259|NCT01597817|Other|chitosan free cotton long sleeved t-shirts and pants.|chitosan free cotton long sleeved shirts and pants.
16173260|NCT01597804|Procedure|Infection Prophylaxis and Management|"Undergo preoperative preparation with the Bathing Bundle"
16173261|NCT01597791|Device|Foley catheter|Foley catheter placement after CSE.
16173262|NCT01597791|Other|No foley catheter|Spontaneous Micturation/ Post Void Residual. the spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals.
16173263|NCT01597778|Biological|Haploidentical Bone Marrow Transplant|"The conditioning regimen consists of:
~Fludarabine (Flu)30 mg/m2 IV Days -6, -5, -4, -3, -2 Cyclophosphamide (Cy) 14.5 mg/kg IV Days -6, -5 Total body irradiation (TBI) 200cGy Day -1
~The GVHD prophylaxis regimen consists of:
~Cy 50 mg/kg IV Days 3, 4 Tacrolimus (IV or PO) beginning Day 5 Mycophenolate mofetil (MMF) 15 mg/kg po three times a day, maximum dose 1 g po TID beginning Day 5 until Day 35"
16173264|NCT01597778|Biological|Double Umbilical Cord Blood Transplant|"The preparative regimen consists of:
~Fludarabine 40 mg/m2 IV Days -6, -5, -4,-3, -2 Cyclophosphamide 50 mg/kg IV Day -6 Total Body Irradiation (TBI) 200 cGy Day -1 for patients who have received cytotoxic chemotherapy within the 3 months of enrollment or an autologous transplant within 24 months of enrollment or 300 cGy Day -1 for patients who have not received cytotoxic chemotherapy within the 3 months of enrollment and who have not received an autologous transplant within 24 months of enrollment.
~The GVHD prophylaxis regimen consists of:
~Cyclosporine beginning Day -3 with dose adjusted to maintain a trough level of 200-400 ng/mL.
~Mycophenolate mofetil (MMF) 15 mg/kg po three times a day, maximum dose 1 g po TID beginning Day -3 until Day 35"
16173265|NCT01597765|Drug|curcuminoids, N-acetylcysteine, deferiprone and vitamin E|receiving curcuminoids 500 mg/day, N-acetylcysteine 200 mg/day deferiprone 50 mg/kg/day and vitamin E 400 IU/day
16173266|NCT01597765|Drug|Curcuminoids and alpha-tocopherol|group 1: receiving curcuminoids 500 mg/day, N-acetylcysteine 200 mg/day and deferiprone 50 mg/kg/day group 2: receiving vitamin E 400 IU/day, N-acetylcysteine 200 mg/day and deferiprone 50 mg/kg/day
16173267|NCT01597752|Biological|Four different concentrations of Blomia tropicalis allergen extract, positive control and negative control|Four concentrations of Blomia tropicalis allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.
16173268|NCT01597739|Drug|JNJ-40346527|Type=exact number; unit=mg; number=100, form=capsule; route=oral use; twice daily.
16173269|NCT01597739|Drug|Placebo|Form=capsule; route=oral use; twice daily.
16173270|NCT01597726|Drug|Misoprostol|Misoprostol 400 mcg administered buccally approximately 3-6 hours prior to D&E, repeated once 3 hours after the first dose if needed
16173271|NCT01597726|Device|Laminaria|Laminaria tents inserted into the cervix 18 to 24 hours prior to D&E
16173272|NCT01597713|Drug|NNC 0148-0000-0362|Subjects will be randomised to receive a single dose of NNC 0148-0000-0362 orally within each dose group
16173273|NCT01597713|Drug|insulin glargine|As an active comparator, one standard dose will be given subcutaneously (s.c., under the skin) within each dose group
16173274|NCT01597713|Drug|placebo|Subjects will receive a single dose of oral placebo within each dose group
16173698|NCT01594749|Drug|Dexamethasone|
16173275|NCT01597713|Drug|NNC 0148-0000-0362|Single low dose administered orally in randomised order on three dosing visits separated by a wash-out period
16173276|NCT01597713|Drug|NNC 0148-0000-0362|Single high dose administered i.v. in randomised order on three dosing visits separated by a wash-out period
16173277|NCT01597713|Drug|NNC 0148-0000-0362|Single high dose administered orally in randomised order on three dosing visits separated by a wash-out period
16173278|NCT01597700|Drug|10mg Ezetimibe|1 tablet taken by mouth
16173279|NCT01597700|Drug|10 mg Ezetimibe - wash out period|1 tablet taken by mouth received after wash out period
16173280|NCT01597687|Procedure|Blood collection|1 blood sample will be collected from each subject.
16173281|NCT01597687|Other|Data collection|Quality of Life and HE questionnaires.
16173282|NCT01597674|Drug|YF476|"There were 4 treatments: 3 dose levels of YF476 (5mg, 10mg, 25 mg) and placebo.
~Each treatment taken by mouth once daily for 14 days (Study Days 1-14). Each subject took 1 of the 4 treatments."
16173283|NCT01597661|Drug|Exposure to any bupropion during the first trimester|"The primary exposure group will be: any exposure to bupropion during the time period from 28 days prior to the last menstrual period through the fourth lunar month. The use of bupropion in combination with other anti-depressants, exposure to SSRI anti-depressants, and exposure to non-SSRI anti-depressants, including tricyclic anti-depressants, during this time period will be explored.
~Mothers of identified infants are contacted within 6 months of delivery and invited to participate in the study by completing a telephone interview, conducted by trained study nurses. The interview addresses demographic, reproductive, and medical factors; medication and vitamin use; cigarette smoking, alcohol, and caffeine consumption, occupational exposures, and dietary intake. Exposure information is obtained directly from the mother in response to questions that focus both on indications for medication use and on medications themselves."
16173284|NCT01597661|Drug|Exposure to bupropion alone during the first trimester|"The secondary exposure group will be: bupropion exposure alone during the time period from 28 days prior to the last menstrual period through the fourth lunar month.
~Mothers of identified infants are contacted within 6 months of delivery and invited to participate in the study by completing a telephone interview, conducted by trained study nurses. The interview addresses demographic, reproductive, and medical factors; medication and vitamin use; cigarette smoking, alcohol, and caffeine consumption, occupational exposures, and dietary intake. Exposure information is obtained directly from the mother in response to questions that focus both on indications for medication use and on medications themselves."
16173285|NCT01597661|Other|Referent group: no exposure to any anti-depressant or anti-smoking drug during pregnancy|"The referent group will be defined as no exposure to any anti-depressant or anti-smoking drug at any time from 28 days prior to the last menstrual period through the end of pregnancy.
~Mothers of identified infants are contacted within 6 months of delivery and invited to participate in the study by completing a telephone interview, conducted by trained study nurses. The interview addresses demographic, reproductive, and medical factors; medication and vitamin use; cigarette smoking, alcohol, and caffeine consumption, occupational exposures, and dietary intake. Exposure information is obtained directly from the mother in response to questions that focus both on indications for medication use and on medications themselves."
16173286|NCT01597648|Drug|Maraviroc|300 mg
16173287|NCT01597648|Drug|Combivir|1 tablet: lamivudine 150mg, zidovudine 300mg
16173288|NCT01597648|Drug|GSK2838510|Maraviroc 300mg, lamivudine 150mg, zidovudine 300mg
16173289|NCT01597635|Drug|Dose 1 GSK2586881|Low dose GSK2586881 administered intravenously
16173290|NCT01597635|Drug|Dose 2 GSK2586881|Medium dose GSK2586881 administered intravenously
16173291|NCT01597635|Drug|Dose 3 GSK2586881|Medium-High dose GSK2586881 administered intravenously
16173292|NCT01597635|Drug|Dose 4 GSK2586881|High dose GSK2586881 administered intravenously
16173293|NCT01597635|Drug|Placebo (saline)|Administered intravenously to match intervention
16173294|NCT01597622|Drug|Belimumab|10 mg/kg administered intravenously over 1 hour every 4 weeks
16173295|NCT01597609|Drug|sibutramine|10 mg, taken orally once per day for 12 weeks
16173296|NCT01597609|Other|sibutramine placebo|taken orally once per day for 12 weeks
16173297|NCT01597596|Biological|alglucosidase alfa|Intravenous (IV) infusion of alglucosidase alfa (4000 L material) 20 mg/kg every other week (QOW)
16173298|NCT01597596|Biological|alglucosidase alfa|IV infusion of alglucosidase alfa (160 L material) 20 mg/kg QOW.
16173299|NCT01597583|Behavioral|Use of MobileMedMinder|Use of an intervention to remind patients to take their medications.
16173300|NCT01597570|Device|Vascular Closure Device|To reduce the TTH(Time to hemostasis) and TTA(Time to ambulation)of common femoral artery(CFA) puncture site
16173301|NCT01597557|Drug|Magnesium Sulfate|2 grams intravenous drip over 30 minutes
16173302|NCT01597557|Other|Placebo|Normal Saline 50 ml intravenous drip over 30 minutes
16173303|NCT01597544|Procedure|CISC instruction pre-operatively|Patients allocated to the pre-operative CISC teaching group will be taught how to perform CISC by one of urogynecology nurses working at the Women's Health Care Centre. Patients will be allowed to practice until they feel comfortable with the technique. This should take approximately 30 minutes. The session will take place on the day of their pre-operative medical appointment (PAF), which normally occurs less than a month before the surgery. If a patient is not seen in PAF or is seen more than a month before her surgery, a separate appointment for CISC teaching during the month preceding the surgery will be organized. Post-operatively, a nurse from the hospital gynecology unit will review the technique to make sure the patient is still comfortable with performing CISC.
16173304|NCT01597531|Drug|Liraglutide|Liraglutide will be started at 0.6 mg injected subcutaneously daily for 1 week and then increased as tolerated to 1.2 mg and then a 1.8 mg daily.
16173305|NCT01597531|Drug|Orlistat|Orlistat will be started initially at a dose of 60 mg taken with the evening meal. Additional doses will be added at breakfast or lunch every 1-2 weeks as tolerated. The patient will be advised to skip drug dosing if little or no fat is contained in the meal. Target dose will 60 mg three times a day and the patients will be advised to take a multivitamin 2 hours before or after Orlistat addition to ensure adequate nutrition.
16173395|NCT01596894|Drug|Azithromycin + Metronidazole|Azithromycin 7.5 mg/kg once daily (maximum 500mg) 5 consecutive days a week for the first 4 weeks and 3 consecutive days a week for the next 4 weeks +metronidazole 10mg/kg X2/day (maximum 1000mg) for 8 weeks.
16173396|NCT01596894|Drug|Metronidazole|Oral metronidazole 10mg/kg X2/day (maximum 1000mg) for 8 weeks.
16173306|NCT01597531|Drug|Liraglutide + Orlistat|Liraglutide will be started at 0.6 mg injected subcutaneously daily for 1 week and then increased as tolerated to 1.2 mg and then a 1.8 mg daily. Patients not tolerating a higher dose will be allowed to remain on the lower dose as long they tolerate the lower. Following titration of Liraglutide to a maximum tolerated dose, Orlistat will be started initially at a dose of 60 mg taken with evening meal. Additional doses will be added at breakfast or lunch every 1-2 weeks as tolerated. The patient will be advised to skip drug dosing if little or no fat is contained in the meal. Target dose will 60 mg three times a day.
16173307|NCT01597518|Drug|Riluzole|100mg BID first 24 hours after the injury; 50mg BID 2--14 days following the injury
16173308|NCT01597518|Drug|Placebo|Placebo 2x in first 24 hours; Placebo 2x day 2--14
16173309|NCT01597505|Drug|Surotomycin|250 mg Surotomycin over-encapsulated tablet administered orally, twice daily for a daily total dose of 500 mg, for 10 days
16173310|NCT01597505|Drug|Vancomycin|125 mg Vancomycin over-encapsulated capsule administered orally, four times daily for a daily total dose of 500 mg, for 10 days
16173311|NCT01597505|Drug|Placebo|Placebo for Surotomycin over-encapsulated tablet administered orally, twice daily for 10 days
16173312|NCT01597492|Biological|Belimumab plus Early Vaccination|Belimumab 10 mg/kg IV plus standard therapy for SLE is administered on Days 28, 42, 56, and every 28 days thereafter through Week 32 (9 doses). Pneumococcal vaccination is administered 4 weeks prior to the first dose of belimumab.
16173313|NCT01597492|Biological|Belimumab plus Late Vaccination|Belimumab 10 mg/kg IV plus standard therapy for SLE is administered on Days 0, 14, 28, and then every 28 days thereafter through Week 28 (9 doses). Pneumococcal vaccination is administered 24 weeks after the first dose of belimumab.
16173314|NCT01597479|Drug|Levobupivacaine|In dPNBs group, we performed ultrasound guided dPNBs on radial and median nerves using low concentration and low volume of long acting local anesthetic (0.125% levobupivacaine, 5 ml per nerve). Using low concentrations of levobupivacaine on target nerves could achieve a prolonged sensitive block in the surgical area without motor block of the hand.
16173315|NCT01597466|Device|Epidural catheter placement|Epidural space is located using Epidrum (Exmoor Innovations, Lisieux Way, Taunton, Somerset TA1 2LB, U.K.)
16173316|NCT01597466|Procedure|Epidural catheter placement|Epidural space is located using loss of resistance technique (saline solution)
16173317|NCT01597453|Behavioral|Lifestyle counseling|Ultrasound examinations of carotid arteries, aorta abdominalis, femoral arteries and lifestyle counseling
16173318|NCT01597440|Drug|N-carbamylglutamate|"Active NCG & Standard of Care Chemical Composition: N-carbamyl-L-glutamic acid (NCG) The daily dose will be 100 mg/kg/ day. The doses are to be divided into 2 equal doses and administered orally or enterally by nasogastric or gastrostomy tube (standard of care will prevail when choosing the mode of drug administration).
~The tablets must be dispersed in a minimum of 2.5-10 ml of water and ingested immediately or administered by fast push through a syringe via a nasogastric or gastrostomy tube. The suspension has a slightly acidic taste.
~This drug will be administered for 7 days after admission or until discharge (whichever is sooner)."
16173319|NCT01597440|Other|Standard of Care|Standard of Care
16173320|NCT01597427|Drug|Clonidine|Administration of 2 μg/kg of intravenous clonidine
16173321|NCT01597427|Drug|Placebo|Injection of placebo solution.
16173322|NCT01597414|Drug|Pertuzumab + trastuzumab|"Trastuzumab: loading dose of 8 mg/kg of body weight on cycle 1, followed by a maintenance dose of 6 mg/kg every 3 weeks.
~Pertuzumab: loading dose of 840 mg on cycle 1, followed by 420 mg for subsequent cycles, every 3 weeks.
~if T-DM1: 3.6 mg/kg IV, every 3 weeks."
16173323|NCT01597414|Drug|Pertuzumab + trastuzumab + metronomic chemotherapy|Pertuzumab and trastuzumab will be administered as in arm A. Cyclophosphamide: daily dose of 50 mg/day. if T-DM1: as in arm A
16173324|NCT01597401|Drug|Aes-103|300 mg Aes-103 powder reconstituted in orange juice to a volume of 100 mL per single dose for oral administration.
16173325|NCT01597401|Drug|Aes-103|1000 mg Aes-103 powder reconstituted in orange juice to a volume of 100 mL per single dose for oral administration.
16173326|NCT01597401|Drug|Aes-103|2000 mg Aes-103 powder reconstituted in orange juice to a volume of 100 mL per single dose for oral administration.
16173327|NCT01597401|Drug|Aes-103|4000 mg Aes-103 powder reconstituted in orange juice to a volume of 100 mL per single dose for oral administration.
16173328|NCT01597401|Drug|Placebo|Orange juice vehicle, a solution that is highly similar in appearance to the Aes-103 orange juice solution.
16173329|NCT01597388|Drug|AZD2014|Single dose followed by multiple dosing or twice daily dosing for 2 days folllowed by 5 days off each week, or twice daily dosing on the first and fourth day of the week
16173330|NCT01597388|Drug|Fulvestrant|IM monthly after loading dose
16173331|NCT01597375|Drug|Placebo Oral Tablet|Participants will take a 60 mg loading dose. After they will take 10 mg by mouth daily if they weigh >60kg or 5 mg by mouth daily if they weigh <60 kg. They will take the drug for 4 weeks prior to the aspirin challenge/desensitization.
16173332|NCT01597375|Drug|Prasugrel Oral Tablet|Participants will take a 60 mg loading dose. After they will take 10 mg by mouth daily if they weigh >60kg or 5 mg by mouth daily if they weigh <60 kg. They will take the drug for 4 weeks prior to the aspirin challenge/desensitization.
16173333|NCT01597362|Procedure|laparoscopy|Trocar access in laparoscopy
16173334|NCT01597362|Procedure|Laparoscopy|"The angle of the Veress needle insertion is 45 for non-obese women. After insertion of the needle, tests to determinate its correct positioning are: the double click test, the aspiration test, the handing drop test, serial intrabdominal gas pressure measurements.
~The volume of CO2 inserted with the Veress needle depends on the intra-abdominal pressure. Adequate pneumoperitoneum should is determined by a pressure of 20 to 30 mm Hg and not by predetermined CO2 volume."
16173335|NCT01597362|Procedure|Laparoscopy|"Direct insertion of the trocar is performed without prior pneumoperitoneum. Infra-umbilical skin incision is wide enough to accomodate the diameter of a sharp trocar/cannual system. The abdominal wall is elevated by pulling on, by hands, two towel clips placed 3 cm on either side of the umbilicus, and the trocar is inserted at a 90°angle.
~On removal of the sharp trocar, the laparoscope is inserted to confirm the presence of omentum or bowel in the visual field."
16173401|NCT01596842|Drug|Omega-3 fatty acid ethylester 90|Omega-3 fatty acid ethylester 90, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks
16173402|NCT01596842|Other|Olive oil|Olive oil, Dosage form :1g soft capsule, Dosage : one capsule, thrice a day, Duration : 12 weeks
16173336|NCT01597362|Procedure|Laparoscopy|A small incision, 1 cm long, is made through the skin of the lower edge of the umbilical fossa. The skin and the subcutaneous adipose tissues are retracted with the Zimmerman dissectors. The anterior rectus fascia is incised with the scalpel. The dissection with the Zimmerman valves allows the exposure of the peritoneum. After the peritoneum is incised, the trocar is inserted under direct vision. The laparoscope is introduced and insufflation is started. At the end of the procedure the fascial defect is closed.
16173337|NCT01597349|Drug|FP01|Lozenge 3 times per day, low dose, high dose, or placebo for 48 hours.
16173338|NCT01597336|Procedure|Tissue plasminogen activator abscess flush|Thirteen ml of 10% tPA in saline at time of drain and twice daily thereafter.
16173339|NCT01597336|Procedure|Saline flush of abscess|Thirteen ml of saline is used to flush abscess at time of drain placement and twice daily thereafter.
16173340|NCT01597310|Drug|Warfarin|single doses at specified time periods
16173341|NCT01597310|Drug|Dexpramipexole|multiple doses
16173342|NCT01597297|Drug|BIIB041 (PR Fampridine)|10 mg twice daily, given orally. Doses of study treatment must be spaced at least 12 hours apart. If a dose of study treatment is delayed or missed, the participant should not dose again until their next scheduled dose. Tablets must be swallowed whole and should be taken without food.
16173343|NCT01597297|Other|Placebo|Twice daily, given orally. Doses of study treatment must be spaced at least 12 hours apart. If a dose of study treatment is delayed or missed, the participant should not dose again until their next scheduled dose. Tablets must be swallowed whole and should be taken without food.
16173344|NCT01597258|Drug|Crizotinib (Xalkori)|"XALKORI® Capsule 200 mg／XALKORI® Capsule 250 mg This surveillance is all cases surveillance based on Japanese regulation. Frequency and duration are according to Package Insert as follows.  The recommended dose schedule of crizotinib is 250 mg taken orally twice daily. Dosing interruption and/or dose reduction may be required based on patients' clinical status. "
16173345|NCT01597245|Drug|80 mg ixekizumab Dosing Regimen|Administered SC
16173346|NCT01597245|Drug|50 mg etanercept|Administered SC
16173347|NCT01597245|Drug|Placebo|Administered SC
16173348|NCT01597232|Other|Transfusion trigger based on WCPTS|Determination of whether a patient needs red blood cell transfusion or which hemoglobin level should be maintained is based on WCPTS
16173349|NCT01597232|Other|Maintenance of hemoglobin level more than 10g/dL|The patient's hemoglobin level is maintained more than 10g/dL perioperatively
16173350|NCT01597232|Other|Transfusion trigger based on experience|Determination of whether the patient need red blood cell transfusion or which hemoglobin level should be maintained is based on the physician's experience
16173351|NCT01597219|Procedure|Reduced intensity haplodentical stem cell transplant|Fludarabine 30mg/m2 IV days -6 to -2 Cyclophosphamide 14.5 mg/kg IV days -6 and -5 Total body irradiation 2Gy day -1 Stem cell transplant: day 0 Cyclophosphamide 50mg/kg days +3 & +4
16173352|NCT01597219|Procedure|Myeloablative haploidentical stem cell transplant|Total body irradiation 12Gy in 8 fractions days -9 to -6 Donor lymphocyte infusion day -6 Cyclophosphamide 60mg/kg IV days -3 & -2 Stem cell transplant day 0
16173353|NCT01597206|Device|Removable partial denture (Chrome Cobalt Distal extension)|For Group A: a distal extension removable denture will be constructed for patients with a reduced posterior dental arch
16173354|NCT01597206|Other|A reduced posterior dental arch|For Group B: Patients with a reduced posterior dental arch will not be provided with a removable denture and will be compared to patients in Group A
16173355|NCT01597193|Drug|enzalutamide|80 mg (2 capsules) or 160 mg (4 capsules) taken orally daily.
16173356|NCT01597193|Drug|anastrozole|1 mg/day
16173357|NCT01597193|Drug|exemestane|The exemestane dose is 25mg daily.
16173358|NCT01597193|Drug|fulvestrant|500 mg every 28 days
16173359|NCT01597193|Drug|enzalutamide|160 mg (4 capsules) taken orally daily.
16173360|NCT01597193|Drug|exemestane|The exemestane dose is 50 mg daily.
16173361|NCT01597167|Dietary Supplement|Magnesium sulfate|4 grams magnesium sulfate in 100 ml IV over 4 hours
16173362|NCT01597154|Behavioral|Lifestyle Counselling|Participants will take part in 2-3 group based peer-led sessions per week in which they will learn about healthy lifestyle choices
16173363|NCT01597141|Behavioral|Family-aided Assertive Community Treatment|The experimental treatment is a combination of family psychoeducation, assertive community treatment, supported education/employment and psychotropic medication.
16173364|NCT01597141|Behavioral|Enhanced standard treatment|In this arm, the subjects will receive the same psychotropic drugs, but will receive individual case management, family education and crisis intervention
16173365|NCT01597128|Device|Flex HD|Flex HD mesh for hernia repair
16173366|NCT01597128|Device|Strattice|Strattice mesh for hernia repair
16173367|NCT01597115|Procedure|Duplex ultrasonography|
16173368|NCT01597102|Other|No interventions|No intervention is planned in this study
16173369|NCT01597076|Dietary Supplement|iridoid enriched mixed fruit beverage|Mixed fruit beverage consisting of noni (Morinda citrifolia) juice, Cornelian cherry (Cornus mas & Cornus officinalis) puree and juice, olive (Olea europea) leaf extract, and other fruit juices and natural flavors
16173370|NCT01597063|Device|SEQureDx Trisomy Test|Plasma samples obtained from maternal blood will be tested using the SEQureDx Trisomy Test, an in vitro diagnostic test that measures circulating cell-free fetal DNA. The test detects the relative quantity of chromosome 21, which is associated with trisomy 21.
16173371|NCT01597050|Drug|R932333|R393233 6% (60 mg/g), bid
16173372|NCT01597050|Drug|Placebo|Placebo, bid
16173373|NCT01597037|Behavioral|Script training|90 minutes/day, 6 days a week; includes 3 weeks of training
16173397|NCT01596868|Drug|gemcitabine and cisplatin|Drug: gemcitabine and cisplatin The GP regimen consists of gemcitabine at a dose of 1,000 mg/m2 by intravenous (i.v.) infusion over 30 min on day 1 and day 8, and cisplatin 80 mg/m2 by i.v. infusion for 4 h on day 1-3, The regime will be repeated every 3 weeks up to a total of 2-3 courses. Concurrent chemoradiotherapy is administrated with 3 cycles of weekly Cisplatin 80 mg/m2 starting on the first day of IMRT.
16173398|NCT01596868|Drug|docetaxel and cisplatin|Drug: Docetaxel and cisplatin The TP regimen consists of docetaxel at a dose of 75 mg/m2/day on day 1,and cisplatin 80 mg/m2 by i.v. infusion for 4 h on day 1-3, The regime will be repeated every 3 weeks up to a total of 2-3 courses. Concurrent chemoradiotherapy is administrated with 3 cycles of weekly Cisplatin 80 mg/m2 starting on the first day of IMRT.
16173374|NCT01597024|Other|Breakfast Study|Participants (male and female, lean and obese, children, teenagers, adults, and elderly) will take part in 4 morning sessions, consuming a test breakfast milk based beverage and appetite. Biomarkers in blood will be measured and behavioural questionnaires completed. We will also collect a single saliva sample from each participant to examine genetic traits related to appetite, food choice, body weight, and energy expenditure. There will be two milk based beverages, one protein enriched (30% protein from calories) and one normal protein (15% protein). Participants will be offered a morning snack buffet to assess ad libitum energy intake. Phase 1 will also include a subgroup of malnourished male and female elderly participants. However, this group will only complete two morning sessions during which they will consume a low protein and a high protein milk based beverage. Appetite will be recorded and libitum energy intake will be measured. In addition, 24hr energy intake will be recorded.
16173375|NCT01597024|Other|fMRI Study|We will fMRI scan normal weight and overweight subjects of both gender from the four different age groups only: 8-10, 13-17, 24-45 and 65-75 years. Participants will be measured twice, on separate days, either after an overnight fast or after a test meal, fed to satiation (because hunger will modulate the response to food presentation). The participants will conduct a computerised task that will be performed in the scanner to assess hedonic responses to food cues. Physiological biomarkers will be measured during both trials for the assessment of appetite hormone circulation. Saliva samples will be taken for DNA analysis. DNA extraction techniques will be used to examine genetic traits linked to appetite, food choice, body weight, and energy expenditure.
16173376|NCT01597011|Procedure|Fibrin Sealant|Use of fibrin sealant for mesh fixation in laparoscopic inguinal hernia repair,
16173377|NCT01597011|Procedure|Tissue-penetrating mesh-fixation|Use of tacks, staples or sutures for mesh fixation in inguinal hernia repair
16173378|NCT01596998|Drug|Levobupivacaine with epinephrine|The subjects were randomized to receive a unilateral TAP block. This was realized using a sterile technique, guided by ultrasound. Two operators with experience in ultrasound-guided regional blocks performed all procedures. A high-resolution linear U.S. transducer (L38x/10-5 MHz Sonosite M-Turbo®, Bothell, WA) and a Stimuplex 100 mm needle, 20 gauge (B. Braun Stimuplex, Melgusen, Germany) were used. After obtaining a clear view of the blocking plane, between internal oblique and transverse muscles, 20 ml of levobupivacaine 0.25% with 5 µg/mL epinephrine were injected.
16173379|NCT01596998|Drug|Levobupivacaine without epinephrine|The subjects were randomized to receive a unilateral TAP block. This was realized using a sterile technique, guided by ultrasound. Two operators with experience in ultrasound-guided regional blocks performed all procedures. A high-resolution linear U.S. transducer (L38x/10-5 MHz, Sonosite M-Turbo ®, Bothell, WA) and a Stimuplex 100 mm needle, 20 gauge (B. Braun Stimuplex, Melgusen, Germany) were used. After obtaining a clear view of the blocking plane, between internal oblique and transverse muscles, 20 ml of levobupivacaine 0.25% were injected.
16173380|NCT01596998|Other|Monitoring|Standard anesthetic monitoring was used, including continuous electrocardiogram, non invasive blood pressure and peripheral oxygen saturation. Later, under local anesthesia a permeable venous line and an arterial line were installed for blood sampling measures to determine local anesthetic plasma levels.
16173381|NCT01596998|Other|Determining the extent of the block|The extent of sensory block was measured by assessment of temperature, soft and hard touch using alcohol, cotton and pin prick respectively. These measurements were made every 10 minutes during the first hour and every 30 minutes to complete 4 hours.
16173382|NCT01596985|Procedure|Ablation using the PlasmaJet system|Ablation of the inner surface of the cyst is then performed using the PlasmaJet system in coagulation mode set at 40, at a distance averaging 5 mm from the tip of the handpiece, and with an exposure time limited to 1 to 2 seconds on each site. Care is taken not to leave any untreated sites and to ablate the edges of the invagination site and the corresponding peritoneal implants on the adjacent broad ligament.
16173383|NCT01596985|Procedure|Cystectomy|"Surgical excision of an ovarian endometrioma by cystectomy involves three distinct areas, each requiring a different excision procedure. Area A from where cyst invagination originates, measures 1 cm² on average and is revealed by lysing adhesions between the ovary and the adjacent broad ligament, leading to the characteristic chocolate fluid evacuation. The excision by scissors of area A allows the surgeon to identify a cleavage plane close to the cyst wall, which can be followed without significant bleeding (area B). Should adhesions appear in the cleavage plane, they are coagulated and cut, so as not to strip the ovarian cortex. Close to the ovarian hilus, for complete cyst removal, adhesions require coagulation using bipolar current and section by scissors (area C)."
16173384|NCT01596972|Device|dBest semi-quantitative urine pregnancy test|The dBest® semi-quantitative urine pregnancy test (Figure 2) is a graduated urine pregnancy test with five different levels of sensitivity: 25 IU/L, 100 IU/L, 500 IU/L, 2000 IU/L, 10000 IU/L. The test detects the level of serum hCG that corresponds to the range between that level and the level above it, i.e. the test would be positive at 500 if the hCG was either 501 or 1999. The tool was validated in a US sample of 196 women, where there was a correlation of 69% between urine hCG and serum hCG. Furthermore, the test had a 10% false negative rate (i.e. recording a level two gradations below the serum level) and a 6% false positive rate (i.e. recording a level two gradations above the serum level)
16173385|NCT01596959|Procedure|Radiofrequency ablation utilising the ECI contact software|irrigated radiofrequency ablation to the right atrium using the ECI contact data
16173386|NCT01596959|Procedure|Radiofrequency ablation without the use of ECI contact data|irrigated RF ablation without the use of ECI contact data
16173387|NCT01596946|Behavioral|Contact tracing mode test at clinic|
16173388|NCT01596946|Behavioral|Self-sampling at home - Sent Test Kit|
16173389|NCT01596933|Dietary Supplement|BioMega SDA®|Echium oil, 15ml/day, 2 times per oral 7.5ml sachet/day, during 7-week radio(chemo)therapy
16173390|NCT01596933|Dietary Supplement|Sunflower oil high oleic|Sunflower oil high oleic, 15ml/day, 2 times per oral 7.5ml sachet/day, during 7-week radio(chemo)therapy
16173391|NCT01596920|Other|Tissue|Allograft Tissue Cellular Repair Matrix
16173392|NCT01596920|Other|Control|Non-adherent Dressing
16173393|NCT01596907|Drug|Ephedrine sulfate with caffeine|Ephedrine sulfate 25-mg with caffeine 200-mg combination capsule to start 5 weeks after gastric bypass surgery at 3 times per day 4 hours apart.
16173394|NCT01596907|Drug|cellulose|sufficient cellulose to fill a placebo capsule identical to the active drug to be taken 3 times per day 4 hours apart for 6 months after gastric bypass surgery
16173399|NCT01596855|Drug|FG-4592|TIW dosing, capsule
16173403|NCT01596842|Other|cholecalciferol|if baseline 25-hydroxyvitamin D levels are < 15 ng/mL : 10,000IU/week, if baseline 25-hydroxyvitamin D levels are 16-30 ng/mL : 50,000IU/week, Duration : 12 weeks
16173404|NCT01596829|Dietary Supplement|Probiotic|Probiotic formula, 10 billion CFU in total once a day for up to 3 weeks
16173405|NCT01596829|Dietary Supplement|Placebo|A capsule with microcrystalline cellulose matching the appearance and taste of the active comparator
16173406|NCT01596816|Radiation|First part of treatment : Conformal irradiation|23 fractions (2 Gy/session), are delivered over 42 days maximum, for a total dose of 46 Gy
16173407|NCT01596816|Procedure|Fiducials placement|Placement of intra-prostatic markers for the tracking
16173408|NCT01596816|Radiation|Second part : hypofractionated stereotactic boost|3 fractions (6Gy/session) are delivered over 5 to 9 days (at least 48 hours between sessions) for a total dose of 18 Gy
16173409|NCT01596803|Procedure|Taking of blood|Taking venous blood samples to analyse oxidant stress
16173410|NCT01596803|Dietary Supplement|needle biopsy of the vastus lateralis muscle|T0 needle biopsy of the vastus lateralis muscle (analysis of oxidative stress and inflammatory markers)During 17 weeks supplementation by Vit E, C , Zn Se After 17 weeks: veinous blood samples and needle biopsy
16173411|NCT01596803|Dietary Supplement|Vit C Vit E Zn Se|T0 venous blood samples and needle biopsy of the vastus lateralis muscle During 17 weeks vit E 400mg/d, Se 200µg/d, Vit C 500mg/day, Zn 25 mg/d After the supplementation of 17 weeks:venous blood samples and needle biopsy of the vastus lateralis muscle
16173412|NCT01596803|Dietary Supplement|Placebo Vit E Placebo Vit C Zn Se|venous blood samples and needle biopsy
16173413|NCT01596790|Other|Blood analysis by EPISPOT and Cellsearch|For each patient, we will perform a counting of CTC before chemotherapy and then at different time points after chemotherapy, using both technologies: EPISPOT and CellSearch®.For the EPISPOT, we will need 15 mL of peripheral blood on EDTA tubes. For each patient, five blood samples will be done: D0, D14, D28, D42 and D56. These different time points will help us to determine when the best moment is for the evaluation of the CTC with this technology.For the CellSearch®, we will need 10 mL of peripheral blood on a specific CellSave tube. Only two samples will be perform: D0 and D28 because Cohen et al. (2008) reported that the best appropriated moment to appreciate the CTC progression is between 3 and 5 weeks after the initiation of the treatment.
16173414|NCT01596777|Drug|Loperamide|20 ml Loperamid-ratiopharm® Lösung (ratiopharm) in 180 ml apple juice prepared before administration
16173415|NCT01596777|Drug|Loperamide placebo|200 ml apple juice
16173416|NCT01596777|Drug|Methylnaltrexone placebo|Methylnaltrexone placebo capsule (identical to MNTX IR and MNTX ER)
16173417|NCT01596777|Drug|Methylnaltrexone 12 mg sc.|RELISTOR 12 mg/0.6 ml Injektionslösung (Wyeth)
16173418|NCT01596777|Drug|Methylnaltrexone IR capsule|Methylnaltrexone bromide 500 mg IR capsule
16173419|NCT01596777|Drug|Methylnaltrexone ER capsule|Methylnaltrexone bromide 500 mg ER capsule
16173420|NCT01596777|Device|Colon Transit|3x1 capsules containing radio-opaque marker of 6 different shapes (in two consecutive study periods, capsules with different shapes of the markers are given)
16173421|NCT01596777|Drug|Sulfasalazine|500 mg Azulfidine® (Pharmacia)
16173422|NCT01596764|Drug|Loperamide placebo|200 ml apple juice
16173423|NCT01596764|Drug|Loperamide|20 ml Loperamid-ratiopharm® Lösung (ratiopharm) in 180 ml apple juice containing 4 mg of loperamide hydrochloride (prepared before administration)
16173424|NCT01596764|Device|Colon Transit|5 capsules containing radio-opaque markers of different shapes, respectively
16173425|NCT01596764|Drug|Sulfasalazine|Azulfidine® Tabletten 500 mg (Pharmacia/Pfizer) containing 500 mg immediate release sulfasalazine
16173426|NCT01596764|Drug|Placebo of MNTX and NLX|Placebo capsule (hard gelatine capsule containing multiple sugar spheres)
16173427|NCT01596764|Drug|Naloxone|Naloxone hydrochloride 20 mg Extended Release Capsule equivalent to 18 mg naloxone (hard gelatine capsule containing a single NLX-ER tablet and multiple sugar spheres)
16173428|NCT01596764|Drug|Methylnaltrexone|Methylnaltrexone bromide 150 mg extended release capsule equivalent to 122 mg methylnaltrexone (hard gelatine capsule containing multiple MNTX-ER micro tablets)
16173429|NCT01596751|Drug|PLX3397|Dosage Form: 100 mg or 200 mg capsules, Dosage: 400 - 1000 mg, oral administration
16173430|NCT01596751|Drug|Eribulin|Dosage Form: 1 mg per 2 mL (0.5 mg per mL); Solution (clear, colorless, sterile, packaged in glass vial) Dosage: 1.4 mg/m2, 2-5 min IV, Day 1, 8 q21 days
16173431|NCT01596738|Drug|Tranexamic Acid|"Tranexamic acid 50mg/ml, 15 mg/kg intravenous after anesthetic induction
~Tranexamic acid 50mg/ml, 15 mg/kg intravenous after neutralization"
16173432|NCT01596738|Drug|Saline|"Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after anesthetic induction
~Equivalent volume of saline, equal to that of 50mg/ml tranexamic acid at the dosage of 15mg/kg, intravenous after neutralization"
16173433|NCT01596725|Biological|Monovalent Avian Influenza VLP (H5N1)|Dose A without Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21
16173434|NCT01596725|Biological|Monovalent Avian Influenza VLP (H5N1)|Dose B without Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21
16173435|NCT01596725|Biological|Monovalent Avian Influenza VLP (H5N1); Adjuvant|Dose B with Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21
16173436|NCT01596725|Biological|Monovalent Avian Influenza VLP (H5N1); Adjuvant|Dose C with Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21
16173437|NCT01596725|Biological|Monovalent Avian Influenza VLP (H5N1); Adjuvant|Dose D with Adjuvant 2; intramuscular, deltoid, Day 0 and Day 21
16173438|NCT01596725|Biological|Saline Placebo|Placebo; intramuscular, deltoid, Day 0 and Day 21
16173439|NCT01596712|Drug|QGE031|QGE031 was supplied as liquid in 2 mL vial for subcutaneous injection.
16173440|NCT01596712|Drug|Placebo|Placebo was supplied as liquid in 2 mL vial for subcutaneous injection.
16173441|NCT01596699|Drug|Alemtuzumab|0.5 mg/kg (max 15 mg or max 6 mg), IV, Day -12 to Day -10 pre-HCT
16173442|NCT01596699|Drug|Busulfan|0.8 mg/kg/dose q6hrs or 1.1 mg/kg/dose q6hrs, IV, Day -9 to Day -6 pre-HCT
16173443|NCT01596699|Drug|Fludarabine|40 mg/m2 or 1.33 mg/kg, IV, Day -5 to Day -2 pre-HCT
16173444|NCT01596699|Drug|Clofarabine|10 mg/m2 or 0.33 mg/kg, IV, Day -5 to Day -2 pre-HCT
16173475|NCT01596491|Procedure|quantitative sensory testing (QST)|with QST the small-fibre function is tested by registering thermal and mechanical thresholds, so that changes in the sensory profile can by specified
16173445|NCT01596686|Drug|one of two possible colon preparation regimens|Patients are randomized to receive one of the two different preparation regimens for colonoscopy usually employed in our unit, polyethylene glycol or sodium picosulphate and magnesium citrate
16173446|NCT01596673|Drug|45-mg hydrocodone bitartrate extended-release tablet (crushed or intact)|"Phase B:
~Eligible subjects will be randomized to treatment sequence XY or YX whereby treatment X is 60 mL of a noncarbonated flavored beverage and treatment Y is hydrocodone bitartrate powder at a dose strength of 45-mg reconstituted in 60 mL of a noncarbonated flavored beverage.
~Phase C:
~Eligible subjects will be randomly assigned to 1 of 4 treatment arms:
~Treatment A: intact placebo tablet, 60 mL noncarbonated flavored beverage, 1 crushed 45-mg hydrocodone bitartrate extended-release tablet.
~Treatment B: intact placebo tablet, hydrocodone bitartrate powder at a dose strength of 45-mg in 60 mL of a noncarbonated flavored beverage and 1 crushed placebo tablet.
~Treatment C: intact 45-mg hydrocodone bitartrate extended-release tablet, 60 mL noncarbonated flavored beverage, and 1 crushed placebo tablet Treatment D: intact placebo tablet, 60 mL noncarbonated flavored beverage, and 1 crushed placebo tablet."
16173447|NCT01596673|Drug|Placebo|Placebo will consist of 60 mL of a non-carbonated beverage without the addition of active treatment
16173448|NCT01596660|Drug|Bupivacaina 0.5%|Bupivacaina 0.5% 20cc
16173449|NCT01596660|Drug|placebo comparator|20 cc of saline solution 0.9%, to infiltrate each side.
16173450|NCT01596647|Drug|caffeine|single dose of the probe drug cocktail contains: caffeine, diclofenac, omeprazole and midazolam
16173451|NCT01596647|Drug|diclofenac|single dose of the probe drug cocktail contains: caffeine, diclofenac, omeprazole and midazolam
16173452|NCT01596647|Drug|omeprazole|single dose of the probe drug cocktail contains: caffeine, diclofenac, omeprazole and midazolam
16173453|NCT01596647|Drug|midazolam|single dose of the probe drug cocktail contains: caffeine, diclofenac, omeprazole and midazolam
16173454|NCT01596647|Drug|TKI258|dovitinib, 5 days on / 2 days off dose schedule
16173455|NCT01596634|Other|questionnaire administration|Ancillary studies
16173456|NCT01596634|Procedure|quality-of-life assessment|Ancillary studies
16173457|NCT01596634|Other|laboratory biomarker analysis|Correlative studies
16173458|NCT01596634|Dietary Supplement|bovine lactoferrin|Given PO
16173459|NCT01596621|Drug|Bendamustine hydrochloride|Bendamustine will be supplied in 20-mL, amber, single-use vials containing 100 mg of bendamustine hydrochloride as a white to off-white lyophilized powder. The drug will be labeled as study drug with the study number and batch number. Patients will be administered bendamustine hydrochloride 120mg/m^2 as a 60-minute infusion, and not more than 120 minutes, on days 1 and 2 of each 21-day treatment cycle for 6 planned cycles or up to 8 total cycles. Dose reductions or modifications may be made as appropriate. Day 1 only of the 21-day cycle may be ±1 day. Day 2 dosing should begin 24 ±4 hours after the start of the day 1 dose.
16173460|NCT01596608|Device|Magnetic Seizure Therapy (MagPro MST)|100% machine output at between 25 and 100 Hz, with coil directed over frontal or vertex brain regions, until adequate seizure achieved. Six treatment sessions, at a frequency of two or three times per week will be administered. If subjects fail to achieve the pre-defined criteria of remission at that point, the dose will be increased to the maximal stimulator output and 3 additional treatment sessions will be provided. This will be repeated a total of 5 times (i.e., maximum treatment number is 24). 24 treatments is typically longer that a conventional ECT treatment course. However, evidence does suggest that longer treatment courses may be needed with MST, particularly in more treatment resistant psychiatric conditions such as OCD and schizophrenia.
16173461|NCT01596582|Behavioral|Risk Assessment|Patients randomized to the experimental arm will be asked a complete the ACNI risk assessment tool after reviewing a web-based colorectal cancer decision aid. The ACNI uses a point based system to stratify patients into low (mean rate of ACN ~3%) versus intermediate/high (~ 8%) risk groups based on responses to 6 items: age (50-59, 60-69, 70+), sex (male/female), race/ethnicity (non-Hispanic black, other), smoking history (never, <20 years, 20+ years), daily alcohol intake (< 2 vs. >/=2 drinks) and use of non-steroidal anti-inflammatory drugs (ever, never). The index represents a prototype version of the Advanced Colorectal Neoplasia Index (Am J Gastroenterol 2015;110:1062-71).
16173462|NCT01596569|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|Daily rTMS treatment for one week. Sham TMS participants receive the same study procedures as patients receiving active TMS.
16173463|NCT01596569|Behavioral|Cognitive Intervention|"Cognitive intervention designed specifically to address the most common cognitive deficits (executive function and memory) in bTBI.
~All participants receive weekly cognitive treatment sessions for 10 weeks."
16173464|NCT01596556|Drug|Nicotine|both groups will be given nicotine lozenges before a VO2 test and a HTT.
16173465|NCT01596556|Other|cigarette smoking|the smokers will smoke 2 cigarettes before a VO2 exam and a HTT.
16173466|NCT01596543|Other|partial and complete sleep deprivation|The subjects will visit our labs 4 times. The second visit will be used as the experimental control. During the third and fourth visits the subject will go through an exercise heat tolerance test and a measurement of their physiological efficiency after a partial and complete sleep deprivation, respectively.
16173467|NCT01596530|Drug|Drug-AZD8931|Active drug for biological activity
16173468|NCT01596530|Drug|Drug-Placebo|Placebo comparator for biological activity comparison
16173469|NCT01596517|Drug|Peginterferon alfa-2a plus ribavirin for HCV genotype 1|Patients with genotype 1: treatment with peginterferon α-2a (Roche, Basel, Switzerland) 180 μg/week and daily ribavirin dose of 1,000 mg (for patients with body weight <75kg) or 1,200 mg (for patients with body weight ≥75kg) for 48 weeks.
16173470|NCT01596517|Drug|Peginterferon alfa-2a plus ribavirin for HCV genotype 2/3|Patients with genotype 2 or 3: treatment with peginterferon α-2a 180 μg/week and daily ribavirin dose of 800 mg for 24 weeks.
16173471|NCT01596504|Drug|Lixisenatide (AVE0010)|"Pharmaceutical form: solution for injection self-administered with a pen-like injector (OptiClik®).
~Route of administration: subcutaneous"
16173472|NCT01596504|Drug|Liraglutide|"Pharmaceutical form:solution for injection
~Route of administration: subcutaneous"
16173473|NCT01596504|Drug|Insulin Glargine|Doses to be adjusted to maintain a fasting self-measured plasma glucose (SMPG) between 4.4 to 5.6 mmol/L (80 to 100 mg/dL)
16173474|NCT01596504|Drug|Metformin|If previously taken metformin to be continued at stable dose throughout the study
16173476|NCT01596478|Behavioral|Treatment as Usual|Participants will receive Treatment as Usual, on an individual basis, for 60-minutes once per week for 12 weeks.
16173477|NCT01596478|Behavioral|Cognitive Motivational Behavior Therapy|Participants will receive a combined motivational and cognitive-behavioral therapy, on an individual basis, for 60-minutes once per week for 12 weeks.
16173478|NCT01596478|Behavioral|12-week wait list|Participants will be randomly assigned to start treatment immediately or to go on a 12-week wait list (where they will start treatment 12 weeks from day of consent).
16173479|NCT01596465|Other|Self-Study using MP3 Player|"Participants in the interventional arm of the study were given an MP3 player which contained eight, 15-second heart sound files (7 pathologic heart sound files and 1 normal heart sound file) alternated with nine leisure songs. MP3 players could play files in order or shuffle files in random order. Each heart sound file was introduced by the narrated phrase Identify this sound,, followed by 10 beats of a heart sound recording, then the narrated identification of the heart sound. Participants were asked to use the MP3 player in order to improve their auscultation skills as often as they could and asked to record their activities while listening, but were given no further training."
16173480|NCT01596465|Other|Multimedia Lecture|Following the pretest, participants in the control arm received a 1-hour multimedia lecture (Power Point) taught by the same faculty member (AGK), which reviewed the pathophysiology, exacerbating and relieving factors, as well as visual diagrams of the heart sounds. The normal and seven pathologic heart sounds were played for participants during the lecture for a total of 2 minutes through high-quality home stereo speakers, exposing learners to 1280 beats in the 1-hour session. Abnormal sounds were taught in groups of systolic, diastolic and extra sounds, and were first introduced by name, and then as unknowns using mixed practice in each of the three sections.
16173481|NCT01596426|Drug|Sancuso|granisetron transdermal system
16173482|NCT01596426|Drug|IV granisetron|IV granisetron
16173483|NCT01596413|Drug|Sancuso|granisetron transdermal system
16173484|NCT01596413|Drug|IV granisetron|IV
16173485|NCT01596400|Drug|granisetron transdermal system|patch
16173486|NCT01596400|Drug|Granisetron IV|IV
16173487|NCT01596387|Drug|Propofol|General anesthesia will be induced administering propofol by effect site TCI system using our previously derived model, the target plasma concentration initially will be set at 4 mcg/ml. After loss of consciousness, rocuronium 0.6mg/kg, and remifentanil 0.2mcg/kg/min will be given to facilitate tracheal intubation. After intubation propofol target will be decreased to 3 for 10 minutes and then adapted to the needs of each patient to maintain stable BIS values between 40 and 50. At the end of surgery propofol infusion will be stopped, and patients will be transferred to the recovery unit extubated. Samples of 2.5 ml of arterial blood will be taken at 2, 5 and 10 min after every new target is set. Thereafter samples will be taken at 2, 5, 10, 15, 30, 60, 120 min after stopping drug infusion. Blood samples will be immediately centrifuged and then stored until analysis.
16173488|NCT01596335|Drug|TA-650|TA-650 at 5 mg per kg body weight on the day of TA-650 administration (day 0) is administered by intravenous infusion slowly over at least 2 hours.
16173489|NCT01596335|Drug|Polyethylene Glycol-treated Human Immunoglobulin (VGIH)|VGIH at 2 g per kg body weight on the day of VGIH administration (day 0) is administered by intravenous infusion slowly over at least 20 hours.
16173490|NCT01596309|Dietary Supplement|Cocoa extract|Participants will follow a hypocaloric diet during two periods of 4 weeks, each. Within these diets, participants will consume daily 2 ready prepared frozen meals containing cocoa extract (0.7 g per meal; 1.4g per day) or nothing (placebo).
16173491|NCT01596296|Device|Transcervical foley catheter|16 French foley catheter insertion
16173492|NCT01596296|Drug|Dinoprostone 10mg|Dinoprostone vaginal insertion
16173493|NCT01596283|Procedure|Standard fluid management|The patient will receive standard fluid management
16173494|NCT01596283|Device|Goal directed fluid therapy with the Edwards EV1000 system|This arm will have fluid therapy guided by the Edwards EV1000 system.
16173495|NCT01596270|Drug|SAR245409|Pharmaceutical form: tablet Route of administration: oral
16173496|NCT01596257|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo allogeneic hematopoietic stem cell transplant
16173497|NCT01596257|Device|CliniMACS|
16173498|NCT01596244|Behavioral|Microclinic|Microclinics consist of 2-8 individuals from pre-existing social networks (friends, relatives, coworkers, neighbors, etc) that voluntarily participate in ongoing education and medical monitoring from local health care professionals, learning and practicing diabetes management strategies, sharing much-needed medical supplies, and exchanging social support in the form of regular microclinic meetings.
16173499|NCT01596231|Dietary Supplement|Kudzu|Kudzu (2 mg) will be administered as a pretreatment 2 ½ hours before a drinking session to see if it will significantly reduce the number of drinks consumed during a single 1 ½ hours drinking session.
16173500|NCT01596231|Dietary Supplement|Placebo|Placebo will be administered as a pretreatment 2 ½ hours before a drinking session
16173501|NCT01596218|Drug|Brentuximab Vedotin|Starting dose is 0.6 mg/kg weekly x 3
16173502|NCT01596205|Behavioral|Robot assisted cognitive training|We developed total 17 software programs for cognitive training with robot which were intended to develop for improvement of following cognitive function;5 programs for memory, 2 for language , 1 for reasoning, 3 for working memory or speed of processing, 2 for calculation and 4 for visuospatial function.
16173503|NCT01596205|Behavioral|Conventional cognitive training group|"Experienced behavioral therapists who had been clinical neuropsychologists for 2 years instructed the participants in cognitive training. Thearpists were familiarized with manuals for cognitive training before study inception, and were instructed to adhere to the manual but were allowed to distribute time flexibly among the programs in the same cognitive domain.
~In all sessions of conventional intervention group, the behavioral therapists showed several questions or instructions on the screen and then the participants answered to the questions with verbal or written words using paper and pencil."
16173504|NCT01596192|Other|PETCT|"CT-PET will be performed within 3 days from acute GVHD diagnosis. Each patient will receive 400-610 MBq (11-16.5 mCi) of 18F-FDG intravenously. After tracer injection, the patients will rest on a comfortable chair during the 18F-FDG-uptake period, and drink with 150-300mg Levolac (Fresenius Kabi, Austria) diluted in 1000-1500cc water. CT-PET will be initiated 45-50 min after injection of the 18F-FDG.ll scans will be performed on a Discovery STE PET/CT scanner (General Electric Medical Systems, Milwaukee, WI).
~CT will be performed 45-50 minutes after drinking the diluted lactulose solution had been ingested. The CT images will be acquired from the diaphragm to the symphysis pubis. After IV administration of 100 ml of nonionic contrast medium at a flow rate of 2.5 ml/sec."
16173505|NCT01596179|Behavioral|Interactive navigational support|Interactive navigational support is provided by a nurse and social worker navigators
16173506|NCT01596179|Behavioral|Internet access|a netbook computer with internet access is provided to participants on the control arm.
16173507|NCT01596166|Drug|Ketorolac Tromethamine|Ketorolac 0.5 mg/kg (max 30 mg) IV
16173508|NCT01596166|Drug|Metoclopramide|Metoclopramide 0.2 mg/kg (max 10 mg) IV
16173509|NCT01596153|Dietary Supplement|Go Live|Enhanced Probiotic, one packet bid until 7 days after discontinuation of antibiotic
16173510|NCT01596140|Drug|Vemurafenib|Starting dose 720 mg by mouth twice a day (3 tablets in the morning and 3 tablets in the evening) for 28-day study cycle.
16173511|NCT01596140|Drug|Everolimus|Starting dose 5.0 mg by mouth daily for 28-day study cycle.
16173512|NCT01596140|Drug|Temsirolimus|Starting dose 15 mg daily over 30-60 minutes on Days 1, 8, 15, and 22 of each 28-day cycle.
16173513|NCT01596127|Drug|Intrathecal Rituximab|"Phase I: Starting dose Rituximab 10 mg intrathecally twice weekly until 2 consecutive CSF samples are negative for the presence of blast cells. Thereafter, rituximab 10 mg intrathecally weekly for additional 4 weeks, followed by intrathecal rituximab 10 mg administered once every other week for an additional 8 weeks.
~Phase II Starting Dose of Rituximab: Maximum tolerated dose from Phase I."
16173514|NCT01596114|Other|Stopping treatment with TKI|stopping until loss of MMR
16173515|NCT01596088|Drug|Dexrazoxane|
16173516|NCT01596075|Drug|Cannabidiol|Cannabidiol will be dissolved in oil to a predefined concentration.Patients developing grade I/II acute GVHD will be treated by IV or oral methylprednisolone 1-2 mg/kg/day and oral cannabidiol at a starting dose of 10 mg twice daily. Doses of cannabidiol can be escalated every day according to clinical response to a maximal dose of 600 mg/day,if no significant drug related side effects present (CTCAE3 grade>2). Cannabidiol will be given up to 90 days.
16173517|NCT01596062|Drug|Simulect®|Simulect® was provided to the study center in its commercial package containing a powder vial with 20 mg of active product and sterile water for injection. The solution should be used immediately after reconstitution. The infusion was prepared by adding at least 50 mL of physiologic or 5% glucose solution to the reconstituted solution (at least 100 mL for 40 mg of Simulect®). Simulect® was transported and kept in a cold environment (2-8°C) as recommended in the summary of product characteristics (SPC).
16173518|NCT01596062|Drug|Neoral®|Neoral® was provided to the study center in its commercial package as 10, 25, 50 or 100 mg soft capsules in thermoformed blister packs.
16173519|NCT01596062|Drug|Certican®|Certican® was provided to the study center in its commercial package as 0.75, 0.5 and 0.25 mg tablets in thermoformed blister packs.
16173520|NCT01596062|Drug|Myfortic®|Myfortic® was administered orally b.i.d. with a 12-hour interval. Tablets could be taken either with or outside meals but consistently throughout the study. To maintain the integrity of the enteric coating, tablets were not to be crushed. Myfortic® treatment was initiated either preoperatively or within 24 hours post transplantation according to local practice in each center. Starting dose was to be 2160 mg/day (1080 mg b.i.d.) for at least 2 weeks and for at most 4 weeks. Patients were then to receive 1440 mg/day (720 mg b.i.d.) until the end of the study. Myfortic® was administered as concomitant treatment to all patients, using the same regimen for all 3 study groups. It was provided to the study center in its commercial package as 180 and 360 mg gastro-resistant tablets.
16173521|NCT01596062|Drug|Corticosteroids|Corticosteroid i.v. therapy could be administered peri or per operatively according to local practice in each center with the same scheme for each patient in the center. Oral corticotherapy was to be initiated rapidly, within one week following transplantation, with a minimal dose of 20 mg/day. Thereafter, the dose was to be decreased according to local practice but oral corticosteroids were to be continued throughout the study with a minimal dose of 5 mg/day.
16173522|NCT01596049|Device|Self-fixating Mesh|Using Self-fixating Mesh for Inguinal Hernia Repair
16173523|NCT01596036|Behavioral|Early appointment (within 10 days)|Patients will receive an appointment to cardiac rehabilitation within 10 days from anticipated hospital discharge.
16173524|NCT01596036|Other|Routine referral (at 5 weeks)|Standard Referral to Cardiac Rehabilitation
16173525|NCT01596023|Device|Breathe NIOV Ventilator|Portable, non invasive open ventilation system
16173526|NCT01596010|Drug|2 mg estradiol / 1 mg norethisterone acetate (NETA)|A single dose of one tablet under fasting conditions separated by a wash-out period of 2 weeks (+0-2 days) between dosing visits. Administered orally.
16173527|NCT01595997|Drug|DLX105|intradermal injections (volume: 0.1 mL) of 0.02 mg (low dose cohort), 1 mg (high dose cohort) DLX105, days: Day 1, Day 4, Day 7 and Day 10
16173528|NCT01595984|Drug|cyclosporin + mycophenolate mofetil|antirejection drug, renal transplantation
16173529|NCT01595984|Drug|everolimus + mycophenolate mofetil|antirejection drug, renal transplantation
16173530|NCT01595971|Behavioral|Continuing education|Includes telemedicine, reminders, video conferences, educational materials for patients and consultants.
16173531|NCT01595971|Other|usual care|Received the usual care provided
16173532|NCT01595958|Drug|Cyclosporine A|Single intravenous bolus of cyclosporine A (2.5 mg/kg) at the onset of resuscitation
16173533|NCT01595958|Procedure|cardio-pulmonary resuscitation|usual care of cardiac arrest
16173534|NCT01595945|Procedure|Gastric bypass|Subjects with a planned gastric bypass surgery are followed-up for resting metabolic rate.
16173535|NCT01595945|Behavioral|Caloric restriction|Subjects receive caloric restriction as calculated by an online weight management program and are followed-up for resting metabolic rate.
16173536|NCT01595932|Dietary Supplement|α-galactosidase|"Treatment was administered at the beginning of each meal (3 times a day) for 2 weeks:
~children < 20kg: 4 drops;
~children > 20kg and < 40kg: 8 drops;
~children > 40kg: 1 tablet."
16173537|NCT01595932|Dietary Supplement|Placebo|"Treatment was administered at the beginning of each meal (3 times a day) for 2 weeks:
~children < 20kg: 4 drops;
~children > 20kg and < 40kg: 8 drops;
~children > 40kg: 1 tablet."
16173538|NCT01595919|Other|Nutritional Intervention|Ad libitum amounts of beverage at a meal
16173539|NCT01595906|Procedure|Ventilated Helmet|The ventilation system is installed on the inner part of the helmet and connected to a bellows and an energy source placed on the vest worn by the soldier. The system's working principal is based on air perfusion with a small ventilator.
16173540|NCT01595893|Drug|Oral Vitamin D 3|40,000 IE vitamin D3 per 70 kg body weight, given twice (2 weeks apart)
16173699|NCT01594749|Drug|Ondansetron|
16173541|NCT01595893|Drug|Miglyol 812 N|Neutral oil of esters extracted from coconut and palm kernel
16173542|NCT01595880|Drug|gemigliptin and metformin HCl extended release|Coadministration of gemigliptin 50mg and metformin HCl extended release 500mg, for 1 day
16173543|NCT01595880|Drug|gemigliptin/metformin HCl extended release|Administration of combination of gemigliptin 50mg/metformin HCl extended release 500mg, for 1day.
16173544|NCT01595867|Drug|Placebo|Lactose (100 mg) placebo tablets crushed; single dose
16173545|NCT01595867|Drug|EMBEDA - morphine sulfate/ naltrexone hydrochloride|EMBEDA (morphine sulfate/naltrexone hydrochloride) 30 mg/ 1.2 mg extended release; capsule contents crushed; single dose
16173546|NCT01595867|Drug|morphine sulfate CR crushed.|Morphine sulfate controlled release 30 mg tablet crushed
16173547|NCT01595854|Drug|dabigatran etexilate|medium dose dabigatran
16173548|NCT01595854|Drug|Ticagrelor|high dose ticagrelor
16173549|NCT01595854|Drug|Ticagrelor|high dose ticagrelor
16173550|NCT01595854|Drug|dabigatran etexilate|low dose dabigatran
16173551|NCT01595854|Drug|dabigatran etexilate|medium dose dabigatran
16173552|NCT01595841|Drug|Sirolimus|3 mg po od loading dose for two days, then 2 mg po od for thirty days
16173553|NCT01595828|Drug|Pitavastatin|
16173554|NCT01595815|Other|Calcium ionophore|Oocytes were activated with calcium ionophore after ICSI
16173555|NCT01595815|Other|Strontium chloride (SrCl2)|Oocytes were activated with strontium chloride after ICSI
16173556|NCT01595802|Device|Nautilus NeuroWave|"The Nautilus NeuroWave device will be utilized on subjects with sub-arachnoid hemorrhage that undergo TCD measurements to diagnose Vasospasm. A recording will be obtained using the device each time a TCD measurement is made.
~In this intervention, patients are recorded using the Nautilus Neurowave device."
16173557|NCT01595802|Device|Transcranial Doppler (TCD)|Subjects with sub-arachnoid hemorrhage undergo TCD measurements to diagnose Vasospasm. Patients that were detected to have a vasospasm using TCD will also be classified as having mild, moderate and severe vasospasm.
16173558|NCT01595789|Drug|Liraglutide|Liraglutide injection pen is administered by the participant once daily by subcutaneous injection. It is given independent of meals. The starting dose is 0.6 mg. After 2 weeks the dose will be increased to 1.2 mg. The dose will be further increased after 4 weeks to 1.8 mg. After a total of 12 weeks of treatment, a wash-out period of 2 weeks follows. Subsequently, the participant will be crossed over to a second period of 12 weeks of treatment with placebo.
16173559|NCT01595789|Drug|Placebo|Volume-matched placebo injection pen is administered by the participant once daily by subcutaneous injection. It is given independent of meals. The starting dose is 0.6 mg volume-matched placebo. After 2 weeks the dose will be increased to 1.2 mg. The dose will be further increased after 4 weeks to 1.8 mg. After a total of 12 weeks of treatment, a wash-out period of 2 weeks follows. Subsequently, the participant will be crossed over to a second period of 12 weeks of treatment with liraglutide.
16173560|NCT01595776|Other|Endothelial progenitor cells intramuscular implant|After marrow stimulation the CD133+ cell count was monitored daily. Each leukapheresis collection was diluted with 10% acide citrate dextrose (ACD-A)CD133 immunomagnetic cell selections were performed . After loco-regional anesthesia and below the knee cutaneous disinfection, 45-48 ml of autologous CD133+ saline solution suspension is administered intramuscularly with 1 ml deep injection through 18G needle. The injections were so allocated: 10 ml in the anterior compartment of leg, 10 ml in the superficial posterior compartment, 10 ml in the deep posterior compartment, 10 ml in the lateral compartment and the remaining part in the foot.
16173561|NCT01595763|Other|D Dimer and ultrasonography|clinical history, Dimer D, ultrasonography
16173562|NCT01595750|Drug|Roflumilast 500|Roflumilast 500 mcg , 12 weeks of treatment
16173563|NCT01595750|Drug|Placebo|Placebo 500 mcg , 12 weeks of treatment
16173564|NCT01595737|Drug|Levosimendan|Levosimendan perfusion for 12 hours before surgery by a single route, at a dosage of 0.1µg/kg/min without receiving the loading dose.
16173565|NCT01595737|Drug|Placebo|Placebo group patients will receive a perfusion of 5% glucose solution. This clear solution, free of visible particles, will have 0.4mg of riboflavin sodium phosphate, 100mg of anhydrous alcohol and water for injection up to 1ml added to it. This solution will be calculated as a dose of 0.1µg/kg/min.
16173566|NCT01595724|Drug|Visanne (Dienogest, BAY86-5258)|Intake of Dienogest 2mg/day to treat Endometriosis according to regular clinical practice.
16173567|NCT01595711|Device|Pain Monitor|Measurement of cutaneous conductance
16173568|NCT01595698|Other|Physical Exercise|"The patients in this group will given a progressive resistance training program twice per week (Tuesday and Thursday) for 20 weeks. The training program followed the American College of Sports Medicine guidelines on resistance training for adults. Training sessions will performed at the same time of day (between 1 pm and 5 pm). The chosen exercises focused on the large muscle groups that are important for the patients' daily routines. The exercises include the leg press, leg curl, vertical traction, chest press, arm extension, arm curl and abdominal crunch using equipment manufactured by Technogym®.
~Every training session will preceded by 5 minutes of warm-up on a Life Fitness® motorized stepper at a constant velocity of 4 km/h. A 1 RM test will be to determine the load settings, as performed in previous studies. The load will readjusted throughout training according to the results of a 1 RM test after the 2nd month of training (the 8th week of training) for each exercise."
16173569|NCT01595698|Other|Control|Patients in this group will to the CEPE twice per week (Tuesday and Thursday) for 20 weeks and performed the same training protocol as the RESEX group. However, the equipment load (weight on each apparatus) is kept at the minimum (below 5% of 1 Repetition maximum - RM) throughout the treatment, without modifying the protocol. Patients execute 2 sets of 15 repetitions with a 1-minute rest interval on all of the equipment.
16173570|NCT01595685|Drug|Telbivudine|Telbivudine 600 mg Daily Oral
16173571|NCT01595685|Drug|Entecavir|Entecavir 0.5 mg Daily Oral
16173572|NCT01595672|Device|AN69 hemofilter|An AN69 hemofilter (1.6 m2 surface area, 35-KD limit; Baxter Healthcare Corp. Deerfield, IL, USA) will be used for EHCVVH.
16173573|NCT01595672|Other|conventional treatments|Patients receive conventional treatments recommended by guidelines only.
16173574|NCT01595659|Behavioral|Passenger|Driving with risk accepting or risk averse passenger
16173575|NCT01595646|Drug|Saline|Saline, administered intranasally twice per day for a 16 week duration
16173692|NCT01594775|Drug|Placebo|two-times daily self-administration of nasal spray containing placebo during five days after wounding.
16173576|NCT01595646|Drug|Insulin detemir|20IU of insulin detemir, administered intranasally twice per day for a 16 week duration (total of 40IU insulin detemir per day)
16173577|NCT01595646|Drug|Insulin|20IU insulin, administered intranasally twice per day for a 16 week duration (total of 40IU insulin per day)
16173578|NCT01595633|Drug|Switching from adefovir (10mg/day) to tenofovir (300mg/day)|active comparator: Nucleoside analogues (Lamivudine 100mg, Telbivudine 600mg, Entecavir 1mg, or Clevudine 30mg/day) + Adefovir 10mg/day Experimental: Nucleoside analogues (Lamivudine 100mg, Telbivudine 600mg, Entecavir 1mg, or Clevudine 30mg/day) + Tenofovir 300mg/day
16173579|NCT01595620|Other|Thermal|Thermal sensation/pain testing
16173580|NCT01595620|Device|Electrical|Electrical sensation/pain testing
16173581|NCT01595620|Other|Capsaicin|Intradermal Capsaicin
16173582|NCT01595607|Other|Diet Treatment|Participants will consume a controlled diet for 6 weeks where all meals will be provided by the facility. Participants will be instructed to eat all foods and only foods provided to them.
16173583|NCT01595594|Drug|Systemic Doxycycline and Sham aPDT|It will be prescribed a protocol of 100mg/day of Systemic Doxycycline for 14 days
16173584|NCT01595594|Drug|aPDT + Doxycycline Placebo|The aPDT protocol will consist in 5 applications on the experimental time 0, 1, 5, 7 and 14 days.
16173585|NCT01595581|Drug|Testosterone|8 weeks supraphysiologic dose testosterone enanthate
16173586|NCT01595581|Drug|Saline|Placebo for 8 weeks
16173587|NCT01595568|Behavioral|Personality-targeted interventions|Motivational and cognitive behavioural interventions targeting four personality profiles. 2 90 minute group sessions with personality-matched peers facilitated by a trained therapist and co-facilitator
16173588|NCT01595568|Behavioral|Personality-targeted interventions|Motivational and cognitive behavioural interventions targeting four personality profiles. 2 90 minute group sessions with personality-matched peers facilitated by a trained therapist and co-facilitator
16173589|NCT01595568|Behavioral|Personality-targeted interventions|Motivational and cognitive behavioural interventions targeting four personality profiles. 2 90 minute group sessions with personality-matched peers facilitated by a trained therapist and co-facilitator
16173590|NCT01595568|Behavioral|Personality-targeted interventions|Motivational and cognitive behavioural interventions targeting four personality profiles. 2 90 minute group sessions with personality-matched peers facilitated by a trained therapist and co-facilitator
16173591|NCT01595555|Behavioral|Stress Free Now|8 week mindfulness online program with the following content: 8 Weekly lesson of the week (audio), 8 Weekly mindfulness practice (audio), Daily articles on concepts and information about stress, relaxation and mindfulness, Daily motivational quotes and tips, Biweekly email reminder to participate in the program.
16173592|NCT01595542|Behavioral|Modified Vaccine Consent Form|"Packet of written immunization materials for parents and students which includes the following:
~Cover letter
~Vaccine promotional flyer
~Vaccine information sheets (one for adolescent vaccination and one for other vaccination)
~Improved consent form
~Note advertising a lottery for free movie tickets for returning the consent form
~Self-addressed stamped envelope"
16173593|NCT01595529|Drug|Cefixime|Cefixime 8 mg/kg/day orally, in 1 dose, with a maximum of 400 mg. Subjects originally receiving Cefdinir will receive Cefixime.
16173594|NCT01595529|Drug|Cephalexin|Cephalexin 50mg/kg/day in 3 divided doses
16173595|NCT01595529|Other|Placebo|Placebo to match the other four active treatments
16173596|NCT01595529|Drug|Trimethoprim/Sulfamethoxazole|8 mg/kg/day of Trimethoprim-sulfamethoxazole (TMP-SMX) orally in 2 divided doses, with a maximum dose of 160 mg twice a day.
16173597|NCT01595516|Drug|Nebivolol|5 mg tablet to be taken by mouth once per day for 12 weeks
16173598|NCT01595516|Drug|Metoprolol|100 mg tablet to be taken by mouth once per day for 12 weeks
16173599|NCT01595516|Drug|Placebo|Gelatin capsule to be taken by mouth once per day for 12 weeks
16173600|NCT01595516|Other|Bradykinin|Bradykinin is infused into the brachial artery at doses of 12.5, 25.0 and 50.0 ng/100 mL of forearm tissue /min. BDK stimulates the endothelial cells to release tissue type plasminogen activator (t-PA). Blood flow in mL/100 mL tissue/min is also measured to BDK.
16173601|NCT01595516|Other|Saline|Baseline or resting forearm blood flow is measured in response to saline for 5 minutes before each drug infusion. t-PA release in response to the saline is also measured.
16173602|NCT01595516|Other|Vitamin C|The acute effects of into-arterial vitamin C on the ability of the endothelium to release t-PA was determined before and after the nebivolol and metoprolol intervention. After allowing sufficient time (~20 minutes) for FBF and plasma t-PA concentrations to return to baseline following the initial infusion of BDK, vitamin C (24 mg/min) was infused at a constant rate while the BDK dose-response curves were repeated. t-PA and FBF were measured.
16173603|NCT01595503|Procedure|rTMS with fMRI-based targeting|Inhibitory (low frequency) 1-Hz rTMS will be applied to the secondary auditory cortex during 10 daily 20-minute treatment sessions. An fMRI scan combined with a language task will be used to localize the secondary auditory cortex, followed by neuronavigation to identify the scalp location overlying the targeted cortex.
16173604|NCT01595503|Procedure|rTMS with landmark-based targeting|Inhibitory (low frequency) 1-Hz rTMS will be applied over the left temporoparietal cortex (TPC) during 10 daily 20-minute treatment sessions, with the stimulating coil located midway between the left temporal (T3) and parietal (P3) scalp landmarks, using the International 10-20 system for EEG.
16173605|NCT01595490|Behavioral|Mind-Body Skills Group|Teaching mind-body skills such as meditation, biofeedback, guided imagery, and meditation in a group setting
16173606|NCT01595477|Behavioral|Mind-Body Skills Group|Teaching mind-body skills such as meditation, biofeedback, guided imagery, and meditation in a group setting
16173607|NCT01595464|Behavioral|Mind-Body Skills Groups|Teaching mind-body skills such as meditation, biofeedback, guided imagery, and meditation in a group setting
16173608|NCT01595451|Procedure|Acupuncture|A licensed acupuncturist will perform acupuncture for six, 30 minute treatment sessions.
16173609|NCT01595438|Drug|Ceftazidime - Avibactam ( CAZ-AVI)|Ceftazidime 2000 mg and 500 mg of avibactam. Patients randomized to receive CAZ-AVI will receive an infusion of CAZ-AVI (2000 mg ceftazidime and 500 mg avibactam) every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 120 minutes
16173610|NCT01595438|Drug|Doripenem|500 mg of Doripenem. Patients randomized to receive Doripenem will receive an infusion of Doripenem 500 mg every 8 hours administered by intravenous (IV) infusion in a volume of 100 mL at a constant rate over 60 minutes
16173611|NCT01595438|Drug|Either switch to oral therapy: 500 mg of Ciprofloxacin (oral)|Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement
16173612|NCT01595438|Drug|or switch to oral therapy: 800 mg/160 mg of sulfamethoxazole/trimethoprim (oral)|Patients are eligible for oral switch after receiving 5 full days of IV therapy and have met protocol specified criteria for clinical improvement
16173613|NCT01595425|Drug|D961H Sachet 20 mg|Each volunteer will receive a D961H sachet 20 mg once in the morning for 5 days.
16173614|NCT01595425|Drug|D961H HPMC capsule 20 mg|Each volunteer will receive a D961H HPMC capsule 20 mg once in the morning for 5 days.
16173615|NCT01595412|Procedure|Laparoscopic Resection Rectopexy|laparoscopic sigmoidectomy with suture rectopexy
16173616|NCT01595412|Procedure|Laparoscopic Ventral Rectopexy|laparoscopic ventral rectopexy with mesh
16173617|NCT01595399|Drug|atropine|Atropine 0.02 mg/kg IV
16173618|NCT01595399|Drug|Placebo|an equivalent volume of normal saline to atropine IV
16173619|NCT01595386|Drug|Hydrocortisone|The drug will be bolused at 50mg/m2 followed by a continuous infusion that will start at 50mg/m2 for the first 48 hours and then be tapered as follows: 40mg/m2/day over 24 hours, 30mg/m2/day over 12 hours, 20 mg/m2/day over 12 hours, 10mg/m2/day over 24 hours, then off.
16173620|NCT01595386|Drug|Normal Saline|This will be bolused and infused in the same manner as the hydrocortisone arm to ensure blinding of study arm.
16173621|NCT01595373|Drug|Acyl ghrelin|Acyl ghrelin 12.5 pg/min infused continuously for 300 minutes
16173622|NCT01595373|Drug|Placebo (Ringer acetate)|Ringer acetate 2 microliter/min for 300 minutes
16173623|NCT01595360|Drug|Placebo|It is applied directly to the bleeding site after tooth extraction
16173624|NCT01595360|Drug|TT-173|It is applied directly to the bleeding site after tooth extraction
16173625|NCT01595347|Drug|Hyper-oxigenated fatty acid|Aplicación tópica de Mepentol (R) en zonas de riesgo de úlceras por presión (sacro, caderas y talones) 1 aplicación/24 horas
16173626|NCT01595347|Other|Olive oil's cream|Application Olive oil's cream to 60% in areas at risk of pressure ulcers (sacrum, hips and heels) 1 application / 24 hours
16173627|NCT01595334|Drug|Cetrorelix|Cetrorelix 0.25 mg/d would be administered by subcutaneous injection to women when the plasma LH is higher (>4.5 mIU/ml) in the study arm
16173628|NCT01595334|Drug|Luprolide Acetate|Women in the control arm would receive Luprolide acetate 1 mg/day by subcutaneous injection
16173629|NCT01595321|Drug|Cyclophosphamide|Cyclophosphamide 200 mg/m2 will be administered one day prior to vaccination (day 0). One dose will be given prior to SBRT and FOLFIRINOX and four additional doses after FOLFIRINOX completion for a total of 5 doses. Additional Cy-vaccine boosts may be given every 6 months thereafter until disease recurrence.
16173630|NCT01595321|Biological|PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1/GM-Neo vaccine|Vaccine will be administered one day after cyclophosphamide (day 1). One dose will be given prior to SBRT and FOLFIRINOX and four additional doses after FOLFIRINOX completion for a total of 5 doses. Additional Cy-vaccine boosts may be given every 6 months thereafter until disease recurrence.
16173631|NCT01595321|Radiation|Stereotactic Body Radiation (SBRT)|SBRT (6.6 Gy) will be administered over 5 days starting between 13-17 days after the first vaccine dose (Arm 2) or within 6-10 weeks of surgery (Arm 1).
16173632|NCT01595321|Drug|FOLFIRINOX|FOLFIRINOX will be administered over 6 cycles starting at least 14 days after SBRT (Arms 1 and 2) and at least 28 days after the first vaccine (Arm 2).
16173633|NCT01595308|Dietary Supplement|Pomegranate juice|Pomegranate juice
16173634|NCT01595295|Other|non interventional|
16173635|NCT01595282|Drug|Ketorolac|For subjects weighing over 50 kg, ketorolac 60 mg in 2cc administered via intramuscular injection 30-60 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ketorolac 30 mg in 1 cc administered via intramuscular injection 30-60 minutes before suction curettage procedure
16173636|NCT01595282|Drug|Ibuprofen|For subjects weighing over 50 kg, ibuprofen 800 mg tablet administered orally 60-90 minutes before suction curettage procedure. For subjects weighing 50 kg or less, ibuprofen 600 mg tablet administered orally 60-90 minutes before suction curettage procedure.
16173637|NCT01595269|Other|eHealth education|In addition to the face-to-face education process currently used at the CHR, Education mode 1 (control), Education mode 2 (static interface) and Education mode 3 (dynamic interface) will be used.
16173638|NCT01595256|Behavioral|muscular strength|12-week moderate intensity walking program
16173639|NCT01595243|Behavioral|telephone consultations about psychoeducation program|experimental group will receive seven instances of telephone follow-up or face-to-face education (the day before discharge and during the first, second, third, fourth, sixth, and eighth weeks after discharge).
16173640|NCT01595230|Procedure|Closing the mesenteric defects with clips during opration|The laparoscopic Roux-en-Y gastric bypass surgery will be performed as usual. The patient will receive the closing of the mesenteric defects (the Petersen´s space and the entero-enterostomy site).The closing will happen at the end of the operation, using clips (herniestapler).
16173641|NCT01595217|Device|3T MRI|diffusion weighted imaging(DWI) of biliary tract with GE Signa 3-tesla device
16173642|NCT01595204|Procedure|Diagnostic laparoscopy|"Laparoscopy will be performed in each case of clinical/radiological suspicious primary advanced ovarian/peritoneal cancer.
~After the introduction of the trocar and the optic, pneumoperitoneum is induced and one or two ancillary trocars are inserted in the iliac fossae bilaterally or where it is possible. A careful complete abdominal and pelvic inspection is carried out in order to identify any possible cause of non optimal cytoreduction. All peritoneal surfaces and the gutters are closely examined and the liver is evaluated by rotating the laparoscope 360° through the umbilical port using grasping forceps as retractors. The small bowel loops and mesentery are evaluated by carefully folding back the various intestinal segments. The pelvis is explored after the bowel loops are retracted in the upper abdomen when possible. At the end of laparoscopy, a PI value is elaborated, based on table given to participant centers."
16173643|NCT01595191|Other|Bach music|"Infants listened to Bach or Mozart using the compact discs entitled Baby Bach and Baby Mozart (Baby smart, Nir Zvi, Israel)."
16173644|NCT01595191|Other|Mozart music|"Infants listened to Bach or Mozart using the compact discs entitled Baby Bach and Baby Mozart (Baby smart, Nir Zvi, Israel)."
16173645|NCT01595178|Behavioral|Combined BNI|Combination brief negotiated interview (BNI) for patients who smoke and drink
16173646|NCT01595165|Procedure|Ultrasound guided subcostal TAP block|Under ultrasound guidance0.375% ropivacaine 10 ml will be injected between rectus abdominis and transverse abdominis and same study solution will be injected at subcostal transversus abdominis plane. This block will be done bilaterally.
16173647|NCT01595165|Procedure|Placebo Ultrasound guided subcostal TAP block|Under ultrasound guidance saline 10 ml will be injected between rectus abdominis and transverse abdominis and same study solution will be injected at subcostal transversus abdominis plane. This block will be done bilaterally.
16173648|NCT01595152|Drug|solifenacin succinate|8 mg once daily for 60 days
16173649|NCT01595152|Drug|fesoterodine|8 mg, once daily for 60 dyas
16173650|NCT01595087|Drug|Osteodex|Seven cohorts; Dose cohort 1; 0.1 mg/kg given every third week, maximum 7 times. Dose cohort 2; 0.3 mg/kg given every third week, maximum 7 times. Dose cohort 3; 0.6 mg/kg given every third week, maximum 7 times. Dose cohort 4; 0.9 mg/kg given every third week, maximum 7 times. Dose cohort 5; 1.2 mg/kg given every third week, maximum 7 times. Dose cohort 6; 1.5 mg/kg given every third week, maximum 7 times. Dose cohort 7; 3.0 mg/kg given every third week, maximum 7 times.
16173651|NCT01595074|Other|medical chart review|Correlative studies
16173652|NCT01595074|Other|laboratory biomarker analysis|Correlative studies
16173653|NCT01595061|Drug|Cisplatin|Given IV
16173654|NCT01595061|Drug|Gemcitabine Hydrochloride|Given IV
16173655|NCT01595061|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16173656|NCT01595061|Procedure|Therapeutic Conventional Surgery|Undergo local core biopsy or surgical excision
16173657|NCT01595035|Behavioral|psychoeducational|Patients randomized to the intervention group will receive written information about pain and pain treatment in a booklet before surgery and contacted by telephone 24, 48, 72 hours and 7 days after surgery to be coached in pain management
16173658|NCT01595022|Drug|Placebo: Flexi ring FR01|Intrauterine device, inserted once for 3 months
16173659|NCT01595022|Drug|Placebo: Flexi ring FR20|Intrauterine device, inserted once for 3 months
16173660|NCT01595022|Drug|Placebo: Ultra low dose levonorgestrel contraceptive system (LCS)|Intrauterine device, inserted once for 3 months
16173661|NCT01595009|Drug|Everolimus (RAD001)|Everolimus was supplied as tablets of 5mg strength.
16173662|NCT01594983|Drug|LCQ908|
16173663|NCT01594983|Drug|Fenofibrate|Fenofibrate once daily 12 weeks
16173664|NCT01594983|Drug|Fish Oil|Fish Oil once daily for 12 weeks
16173665|NCT01594983|Drug|Placebo of LCQ908|Matching placebo of LCQ908
16173666|NCT01594983|Drug|Placebo of fenofibrate|Matching placebo of fenofibrate
16173667|NCT01594983|Drug|Placebo of fish oil|Matching placebo of fish oil capsule
16173668|NCT01594970|Drug|Bimatoprost 0.01%|1 drop in the affected eye(s), administered in the evening for 12 weeks.
16173669|NCT01594957|Drug|LCQ908|Participants will receive a single oral dose of LCQ908
16173670|NCT01594931|Drug|pyronaridine/artesunate|Tablets of fixed dose combination of pyronaridine and artesunate at a ratio of 3:1. The tablets were taken daily for 3 days.
16173671|NCT01594918|Drug|Cabazitaxel|25 mg/m2 or 20 mg/m2, IV, once every 21 days
16173672|NCT01594918|Drug|Mitoxantrone|4 mg/m2, 6 mg/m2, 8 mg/m2, 10 mg/m2, or 12 mg/m2, IV, once every 21 days
16173673|NCT01594918|Drug|Prednisone|5 mg PO BID
16173674|NCT01594918|Drug|Pegfilgrastim|6 mg, SC, once every 21 days
16173675|NCT01594905|Drug|Entecavir + Tenofovir (MDR group)|Entecavir 1.0mg + Tenofovir 300mg
16173676|NCT01594892|Radiation|Radiosurgery|Fractionated radiosurgery using intensity-modulated treatment planning and volumetric image-guided treatment delivery
16173677|NCT01594879|Device|MIrena(LNG-IUS), oral MPA|"General Name/Brand name: Mirena - SCHERING Active ingredient: levonorgestrel 52mg Description: Mirena is a hormone-releasing T-shaped intrauterine system. A removal thread is attached to a loop at the end of the vertical stem of the T-body.
~General Name/Brand name:Farlutal tab. 500mg/ Pfizer Active ingredient: Medroxyprogesterone Acetate"
16173678|NCT01594866|Drug|escitalopram|escitalopram 20mg and 30mg p.o. daily, 6 weeks
16173679|NCT01594866|Drug|escitalopram|escitalopram 10mg p.o. for 1 week, and escitalopram 20mg p.o. for 3 weeks before randomized to placebo and experimental groups
16173680|NCT01594853|Behavioral|exercise training|The exercise program uses a local Curves® gym to provide an individualized program of strength and cardiovascular training. The program is expected to be performed for 45 minutes 4-6 days per week.
16173681|NCT01594840|Device|Changing chat|Diapers with tips
16173682|NCT01594827|Drug|Inhaled Vancomycin|On Days 1-28, subjects will receive nebulized Vancomycin. This will be supplied as a 250 mg solution to be nebulized two times a day for 28 days in 5cc sterile water. Patients will use a Pari Sprint nebulizer and Pari Vios compressor as the delivery system.
16173683|NCT01594827|Drug|Placebo (Sterile Water)|On Days 1-28, subjects will receive 5cc of a nebulized Placebo (Sterile water) twice a day. This is a taste (quinine 0.1mg/mL) matched nebulized placebo (sterile water). Patients will use a Pari Sprint nebulizer and Pari Vios compressor as the delivery system.
16173684|NCT01594827|Drug|Rifampin|"Oral Rifampin by mouth for 28 days
~>45 kg: 600 mg by mouth daily
~35-45 kg : 450 mg by mouth daily
~25-34.9 kg: 300 mg by mouth daily"
16173685|NCT01594827|Drug|Trimethoprim/Sulfamethoxazole (TMP/SMX)|"Oral trimethoprim/sulfamethoxazole (DS-160/800)
~>45 kg: two DS tablets twice a day by mouth (320/1600)
~25-45 kg: one DS tablet twice a day by mouth (160/800)"
16173686|NCT01594827|Drug|Doxycycline|"If sulfa intolerant or TMP/SMX Resistant, use instead oral doxycycline
~>45 kg: 100 mg by mouth twice a day
~35-45 kg : 75 mg by mouth twice a day iii. 25-34.9 kg: 50 mg by mouth twice a day"
16173687|NCT01594827|Drug|Mupirocin Intranasal Creme|Mupirocin 2% intranasal creme: half of single use tube applied into each nostril twice a day for 5 days.
16173688|NCT01594827|Drug|4% chlorhexidine gluconate liquid skin cleanser|Hibiclens 15cc liquid skin cleanser packets (4% chlorhexidine gluconate): use three packets once weekly for four weeks in the shower from the neck to toes, with attention on the axilla, groin, and buttocks.
16173689|NCT01594814|Procedure|RFA|radiofrequency ablation of slow pathway or accesory pathway
16173690|NCT01594801|Device|InsuPad|Use of the InsuPad for at least 3 times a day.
16173691|NCT01594775|Drug|Syntocinon (Oxytocin) nasal spray|two-times daily self-administration of nasal spray containing active substance (oxytocin) during five days after wounding.
16173693|NCT01594762|Drug|Topical pexiganan cream 0.8%|14 days of treatment
16173700|NCT01594749|Drug|Dexamethasone Placebo|
16173701|NCT01594749|Drug|Ondansetron Placebo|
16173702|NCT01594749|Drug|Rescue Therapy|
16173703|NCT01594736|Drug|ORSIRO|due randomization ORSIRO will be implanted
16173704|NCT01594736|Device|XIENCE PRIME DES|due randomization XIENCE PRIME DES will be implanted
16173705|NCT01594723|Drug|120 mg LY2784544|Administered orally
16173706|NCT01594697|Drug|Metformin|
16173707|NCT01594684|Device|balloon angiolplasty - drug coated balloon (Cotavance, Medrad Inc.)|balloon inflation
16173708|NCT01594684|Device|drug coated balloon inflation (Cotavance, Medrad Inc.)|Balloon inflation
16173709|NCT01594684|Device|uncoated balloon (e.g. Admiral, Medtronic)|balloon inflation
16173710|NCT01594684|Device|balloon inflation, drug coated balloon (Cotavance, Medrad Inc.)|ballon inflation
16173711|NCT01594671|Drug|Tranexamic Acid|"Two dosage during the surgical intervention: the first dosage 15-30' before the leg ischemia and the second dosage at 60 -90' after the first dosage.
~Each dosage: 2 ampoules of 500mg/5 mL/ampoule"
16173712|NCT01594671|Drug|Tranexamic Acid|One dose before the closure of the knee joint: a solution containing 1g of tranexamic acid in 50 ml of normal saline (0.9% sodium chloride) applied with a syringe diffuser.
16173713|NCT01594671|Other|haemostasia|The surgical habitual haemostasia: electrocoagulation of the bleeding tissues
16173714|NCT01594658|Procedure|Foam sclerotherapy|Foam application of 1% (Sklerol®, ICV Pharma, Bogota-Colombia), Reg INVIMA: 2002M-0001016, guided by ecography of insufficient superficial veins, doses from 10-40 cc of foam until obtaining endoluminal occlusion of the vein. The patient will rest for 8 minutes and then the leg will be covered with elastic bandage.
16173715|NCT01594658|Procedure|conservative|This arm only has medical standard handling (healings performed by the nurse group)
16173716|NCT01594645|Procedure|Sperm selection by conventional / polarized light microscopy|Selecting spermatozoa for ICSI using conventional and polarized light microscopy
16173717|NCT01594632|Drug|Jadelle|LNG containing subdermal contraceptive implant
16173718|NCT01594632|Drug|Sino-implant (II)|LNG containing subdermal contraceptive implant
16173719|NCT01594619|Drug|Naloxegol|Oral 25mg tablet
16173720|NCT01594619|Drug|Diltiazem XR|Oral 240mg tablet
16173721|NCT01594606|Behavioral|Animal-assisted intervention|The experimental group will receive 10 weeks of classroom training and hands-on experience working with dogs to teach them basic obedience skills. Each participant will work with the same dog each week. The active control group will receive 10 weeks of classroom training and will walk a different dog each week but will not teach obedience skills to the dogs.
16173722|NCT01594593|Behavioral|Acceptance and Commitment Therapy|group-based behavioral workshop to address cancer-related distress
16173723|NCT01594580|Other|Antimicrobial impregnated scrubs|Scrubs are impregnated with an antimicrobial product
16173724|NCT01594580|Other|Non-impregnated scrubs|
16173725|NCT01594567|Other|Dietary pulses|beans, peas, chickpeas, or lentils in whole or flour form
16173726|NCT01594528|Other|pain tests|pain induction with pressure application or ischemia on the arm
16173727|NCT01594515|Drug|BI 1015550|High dose powder for oral solution
16173728|NCT01594515|Drug|BI 1015550|Medium dose powder for oral solution
16173729|NCT01594515|Drug|BI 1015550|Low dose powder for oral solution
16173730|NCT01594515|Drug|BI 1015550|Low dose powder for oral solution
16173731|NCT01594515|Drug|BI 1015550|Low dose powder for oral solution
16173732|NCT01594515|Drug|Placebo|Solution for oral administration
16173733|NCT01594515|Drug|BI 101550|High dose powder for oral solution
16173734|NCT01594515|Drug|BI 1015550|Low dose powder for oral solution
16173735|NCT01594515|Drug|BI 1015550|Medium dose powder for oral solution
16173736|NCT01594515|Drug|BI 1015550|Medium dose powder for oral solution
16173737|NCT01594502|Drug|Dutasteride|0.5 mg daily
16173738|NCT01594502|Drug|Placebo|Placebo Comparator
16173739|NCT01594489|Drug|Aminophylline|"200 mg of aminophylline administrated intravenously as a short infusion, started in emergency department, before primary angioplasty and contrast medium administration
~Sodium bicarbonate (154 mEq/L in dextrose and H20) 3mL/kg for 1 hour before contrast medium, followed by an infusion of 1 mL/kg/h for 12 hours after procedure
~N-acetilcysteine: intravenous bolus of 1200 mg before angioplasty and 1200 mg twice daily for the 48 hours after PCI"
16173740|NCT01594489|Drug|Hydration plus N-acetylcisteine|"Sodium bicarbonate (154 mEq/L in dextrose and H20) 3mL/kg for 1 hour before contrast medium, followed by an infusion of 1 mL/kg/h for 12 hours after procedure
~N-acetilcysteine: intravenous bolus of 1200 mg before angioplasty and 1200 mg twice daily for the 48 hours after PCI"
16173741|NCT01594476|Drug|Levonorgestrel IUS|20 mcg levonorgestrel per day in intrauterine system for Mirena IUS Copper T intrauterine device
16173742|NCT01594463|Other|ultrasound examination|ultrasound examination between week 30+1 weeks to 31+6 weeks
16173743|NCT01594463|Other|ultrasound examination|ultrasound examination between 34+1 weeks to 35+6 weeks
16173744|NCT01594450|Biological|Biological mesh|patients will undergo the implantation of a biological mesh (after debridement and treatment of the infection) at the same time as the primary operation, or within one month of randomization.
16173745|NCT01594450|Procedure|without biological mesh|patients undergo traditional wound care (debridement and treatment of infection), without placement of a biological mesh. For arm B, the common wound care used follows the normal practice of the treating surgeon, except the placement of the biological mesh, which must not be performed within 6 months of randomization In cases of treatment failure at 6 months, patients of arm B are allowed to undergo any treatment which the treating surgeon views suitable, including a surgical procedure with implantation of a biological mesh
16173746|NCT01594437|Biological|TCN-202|Human monoclonal neutralizing antibody that recognizes a broadly conserved functional epitope on HCMV. One or two doses will be administered by intravenous infusion.
16173747|NCT01594437|Biological|Placebo|One or two doses administered by intravenous infusion.
16173748|NCT01594424|Drug|Tocilizumab|Tocilizumab 8mg/kg on Days 0, 15, 30, 45, 75, 105, 119, 135, 149, and 180
16173749|NCT01594424|Drug|Intravenous Immunoglobulin|All HS who meet criteria for desensitization will receive IVIG 10% (2.0 g/kg [maximum 140 g per dose] on days 1 and 30).
16173750|NCT01594411|Diagnostic Test|Corus CAD|Age/Sex/Gene Expression Score (ASGES)
16173751|NCT01594398|Drug|entinostat|10 mg, po, q14 days, until progression or intolerable toxicity
16173752|NCT01594398|Drug|entinostat|10 mg, po, q14 days, until progression or intolerable toxicity
16173753|NCT01594398|Drug|Erlotinib|Erlotinib: NSCLC pts beginning C2D1,150 mg, po, qd.
16173754|NCT01594398|Drug|Erlotinib|Erlotinib: NSCLC pts beginning C2D1,150 mg, po, qd.
16173755|NCT01594398|Drug|Exemestane|Exemestane: Breast cancer pts beginning C2D1,25 mg, po, qd.
16173756|NCT01594398|Drug|Exemestane|Exemestane: Breast cancer pts beginning C2D1,25 mg, po, qd.
16173757|NCT01594385|Biological|Seprafilm|"Two sheets of the Seprafilm material will be applied at each reoperation. Each sheet will be cut into 1x1 inch squares and applied to the following anatomic areas:
~Two Seprafilm pieces between the liver and the anterior abdominal wall
~Four pieces over the exposed bowel surfaces anteriorly
~Two slightly staggered pieces of Seprafilm in each colic gutter
~Two pieces in the pelvic area.
~If any of the above areas involve an anastomosis or bowel repair, then the Seprafilm should be placed at least 1 inch away from the anastomosis and/or bowel repair."
16173758|NCT01594372|Procedure|Laparoscopic supracervical hysterectomy with sacropexy|Will involve laparoscopic entry to the abdomen to remove the uterus and suspension of the cervix and vaginal cuff to the sacrum with mesh. We will allow surgeons to conduct the surgery as they have perfected it
16173759|NCT01594372|Procedure|Vaginal hysterectomy with uterosacral colposuspension|Will involve removing the uterus vaginally followed by suspending the vaginal cuff to the high (proximal) uterosacral ligaments bilaterally restoring the vagina to its normal axis.
16173760|NCT01594359|Other|Biofortified beans|Comparison of two types of the common bean that are similar in all aspects except their iron concentration - one has a high iron concentration while the other has low iron concentration
16173761|NCT01594359|Other|BEAN|Placebo
16173762|NCT01594346|Drug|Alpha-Tocopherol|1,000 International Units, two times a day for 36 months
16173763|NCT01594346|Drug|Sugar Pill|
16173764|NCT01594333|Drug|Methotrexate|Tablet, Oral, Target dose 15-20 mg weekly plus 1.0 mg folic acid 6 days/week
16173765|NCT01594333|Drug|Placebo|Tablet, Oral, weekly plus 1.0 mg folic acid 6 days/week
16173766|NCT01594320|Biological|Monovalent Avian Influenza VLP (H5N1)|Dose A without Adjuvant 1; intramuscular, deltoid, Day 0 & Day 21
16173767|NCT01594320|Biological|Monovalent Avian Influenza VLP (H5N1)|Dose B without Adjuvant 1; intramuscular, deltoid, Day 0 & Day 21
16173768|NCT01594320|Biological|Monovalent Avian Influenza VLP (H5N1); Adjuvant|Dose B with Adjuvant 1; intramuscular, deltoid, Day 0 & Day 21
16173769|NCT01594320|Biological|Monovalent Avian Influenza VLP (H5N1); Adjuvant|Dose C with Adjuvant 1; intramuscular, deltoid, Day 0 & Day 21
16173770|NCT01594320|Biological|Monovalent Avian Influenza VLP (H5N1); Adjuvant|Dose D with Adjuvant 1; intramuscular, deltoid, Day 0 & Day 21
16173771|NCT01594320|Biological|Saline placebo|Placebo; Intramuscular, deltoid, Day 0 & Day 21
16173772|NCT01594294|Device|AOSEPT® Plus contact lens solution|Hydrogen peroxide-based cleaning and disinfection system
16173773|NCT01594294|Device|ReNu MultiPlus® contact lens solution|Polyaminopropyl biguanide (PHMB) preserved multipurpose solution
16173774|NCT01594294|Device|Etafilcon A contact lenses|Hydrogel contact lenses worn on a daily wear basis for 14 days (Screening Phase) and 3 months (Investigational Phase). During the Investigational Phase, the contact lenses lenses were worn a minimum of six hours per day, 5 days per week, with a fresh pair dispensed every 2 weeks.
16173775|NCT01594294|Device|Lotrafilcon B contact lenses|Silicone hydrogel contact lenses worn on a daily wear basis for 30 days (Screening Phase) and 3 months (Investigational Phase). During the Investigational Phase, the contact lenses lenses were worn a minimum of six hours per day, 5 days per week, with a fresh pair dispensed monthly.
16173776|NCT01594294|Device|COMPLETE® MPS Easy Rub® Formula contact lens solution|PHMB 0.0001% and poloxamer 0.05% multipurpose solution
16173777|NCT01594281|Drug|Ranibizumab 0.5 mg|Pre-filled syringe for intravitreal injection
16173778|NCT01594281|Procedure|Panretinal laser photocoagulation|PRP treatment following DRS guidelines
16173779|NCT01594268|Drug|Everolimus|A prospective, open-label study to assess safety of Certican in kidney transplant patients
16173780|NCT01594255|Drug|sotrastaurin|
16173781|NCT01594255|Drug|sotrastaurin|
16173782|NCT01594255|Drug|placebo to sotrastaurin|
16173783|NCT01594255|Drug|Avelox|
16173784|NCT01594242|Drug|Bortezomib|
16173785|NCT01594229|Drug|ABT-199|ABT-199 is taken orally once daily for 3 days out of each 28 day cycle. This is a dose escalation study, therefore the dose of ABT-199 will change throughout the study.
16173786|NCT01594229|Drug|Rituximab|Rituximab will be given by intravenous infusion for 1 day out of each 28 day cycle.
16173787|NCT01594229|Drug|Bendamustine|Bendamustine will be given by intravenous infusion for 2 days out of each 28 day cycle.
16173788|NCT01594216|Drug|Ruxolitinib|
16173789|NCT01594216|Drug|Exemestane|
16173790|NCT01594203|Other|F18-FGD PET/CT|
16173791|NCT01594190|Behavioral|physical activity 15 minutes/day|weight-bearing treadmill, pulsereserve increase of 50 %
16173792|NCT01594190|Behavioral|physical activity, 2 x 30 minutes/day|weight-bearing treadmill, pulsereserve increase of 50 %
16173793|NCT01594177|Drug|Afatinib|20 mg daily for 17 weeks (first two weeks every second day).
16173794|NCT01594177|Drug|Trastuzumab|First cycle: loading dose 8 mg/kg (day 1 q day 22), thereafter maintenance dose for 9 cycles: 6 mg/kg (day 1 q day 22).
16173795|NCT01594177|Drug|Paclitaxel|80 mg/m² i.v. given weekly on day 1 q day 8 for 12 weeks.
16173796|NCT01594177|Drug|Epirubicin|90 mg/m² i.v. given on day 1 q day 22 for 4 cycles.
16173797|NCT01594177|Drug|Cyclophosphamide|600 mg/m² i.v. given on day 1 q day 22 for 4 cycles.
16173798|NCT01594164|Radiation|Cone Beam Computed Tomography|CBCT scan of upper airway, in upright position.
16173799|NCT01594164|Radiation|High Resolution Computed Tomography|HRCT scan of upper airway, in supine position.
16173800|NCT01594151|Radiation|Cone Beam Computed Tomography|CBCT scan of upper airway at visit 1
16173801|NCT01594138|Other|Standardized questionnaires and a ubiquitous questionnaire|Columbia Suicide Severity Rating Scale, Suicidal Ideation Questionnaire,Peabody Caregiver Background Form,CCHMC Suicide History Form,and ubiquitous questionnaire(UQ ver.2011)
16173802|NCT01594125|Drug|Nintedanib high dose|twice daily oral dosing
16173803|NCT01594125|Drug|Nintedanib low dose|twice daily oral dosing
16173804|NCT01594125|Drug|Nintedanib medium dose|twice daily oral dosing
16173805|NCT01594125|Drug|Nintedanib medium dose|twice daily oral dosing
16173806|NCT01594125|Drug|Nintedanib high dose|twice daily oral dosing
16173807|NCT01594099|Radiation|irradiation|"EBRT: 3D-CRT pelvic radiation, 95%CTV DT 50.4Gy/28f. Radiation volume Cover the gross disease, whole uterus ,parametria, and regional lymph nodes area. Upper border：branching of abdominal aorta. Lower border: the inferior margin of obturator foramen.
~Brachytherapy :Using an intrauterine tandem and colpostats. The total dose of A point is DT 20-25Gy/4-5f (EQD2=25-31.25 Gy，α/β=10)."
16173808|NCT01594099|Drug|Cisplatin|"EBRT: 3D-CRT pelvic radiation, 95%CTV DT 50.4Gy/28f. Radiation volume Cover the gross disease, whole uterus ,parametria, and regional lymph nodes area. Upper border：branching of abdominal aorta. Lower border: the inferior margin of obturator foramen.
~Brachytherapy: Using an intrauterine tandem and colpostats. The total dose of A point is DT 20-25Gy/4-5f (EQD2=25-31.25 Gy，α/β=10).
~Chemotherapy: Cisplatin (20mg /week) will be carry out in the 2nd to 6th week during radiation therapy."
16173809|NCT01594099|Drug|liposome paclitaxel|"EBRT: 3D-CRT pelvic radiation, 95%CTV DT 50.4Gy/28f. Radiation volume Cover the gross disease, whole uterus ,parametria, and regional lymph nodes area. Upper border：branching of abdominal aorta. Lower border: the inferior margin of obturator foramen.
~Brachytherapy: Using an intrauterine tandem and colpostats. The total dose of A point is DT 20-25Gy/4-5f (EQD2=25-31.25 Gy，α/β=10).
~Chemotherapy: Liposome paclitaxel (40mg /m2/2weeks) will be carry out in the 2nd ,4th,6th week during radiation therapy."
16173810|NCT01594086|Dietary Supplement|green tea powder|Consuming 2 g/day of green tea powder in three times divided for 3 months
16173811|NCT01594060|Drug|Insulin, regular - act rapid|4 shots of regular insulin: 3 before meals and one at bedtime.
16173812|NCT01594060|Drug|Insulin glulisine, Insulin glargine|1 shot glargine at bedtime 3 shots glulisine before meals
16173813|NCT01594047|Drug|ketamine infusion|Ketamine infusion scheme: 5mcg/Kg/min from induction od anaesthesia for 10 min, than 2,5mcg/Kg/min for 20 min and than 2 mcg/Kg/min to the end of surgery
16173814|NCT01594047|Drug|Methadone PCA|Methadone administered by a PCA system (dose 2 mg, lock-out 12min.)
16173815|NCT01594034|Procedure|expired air|collection of expired air from ventilator
16173816|NCT01594021|Drug|Gelatin 500 mL|intravenous administration
16173817|NCT01594021|Drug|Gelatin 50 mL|intravenous administration
16173818|NCT01594008|Other|Breakfast meal with placebo powder|Zero serving equivalents (1 serving equivalent = ½ cup fresh raw blueberries) of blueberries in the form of a mixed side dish comprising frozen yogurt, sugar, and placebo powder.
16173819|NCT01594008|Other|Breakfast meal with 2 serving equivalents of blueberries|Two serving equivalents (1 serving equivalent = ½ cup fresh raw blueberries) of blueberries in the form of a mixed side dish comprising frozen yogurt, sugar, and freeze-dried blueberry powder.
16173820|NCT01594008|Other|Breakfast meal with 4 serving equivalents of blueberries|Four serving equivalents (1 serving equivalent = ½ cup fresh raw blueberries) of blueberries in the form of a mixed side dish comprising frozen yogurt, sugar, and freeze-dried blueberry powder.
16173821|NCT01593995|Drug|Epidermal growth factor (EGF) ointment|"EGF Ointment evenly apply to skin lesion every 12 hr/ day. If the skin lesion has been no improvement even though EGF ointment applied for 8 weeks, stopped study and assess it as no effect"
16173822|NCT01593982|Other|repetitive Transcranial Magnetic Stimulation (rTMS)|"20 daily sessions: each with 25 trains of 10 seconds at 5Hz, with a 20 second inter-train interval, at an intensity of 120% of motor threshold.
~Site: Left Dorsolateral Prefrontal Cortex"
16173823|NCT01593969|Dietary Supplement|RUTF/Flax Oil|Ready to Use Therapeutic Food
16173824|NCT01593969|Dietary Supplement|RUTF/Flax Oil plus additional Fish Oil|Ready to Use Therapeutic Food
16173825|NCT01593969|Dietary Supplement|Standard RUTF|Standard formulation RUTF given according to National Guidelines
16173826|NCT01593956|Behavioral|tDCS|
16173827|NCT01593943|Behavioral|CHARM|CHARM will be conducted via three 30-minute counseling sessions delivered in the rural setting, with the first session required and the 2nd and 3rd sessions optional. The first two CHARM sessions will be for men only to build family planning (FP) and gender equity (GE) awareness and investment, and the third session will be for the couple with an emphasis on FP services, shared decision-making and marital communication. The three sessions can occur anytime within a 3 month timeframe but with a minimum of 1 week between sessions. All sessions and FP services (pill, condom, EC) will be provided at no cost to patients.
16173828|NCT01593930|Other|Lidocaine(IANB)|Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine
16173829|NCT01593930|Other|1 Articaine(Infiltration)|Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine
16173830|NCT01593930|Other|2 Articaine(Infiltration)|Buccal infiltration of two 4% Articaine cartridges with 1/100000 epinephrine
16173831|NCT01593930|Other|Lidocaine(IANB)+1Articaine(Infiltration)|Inferior alveolar nerve block using one 2% Lidocaine cartridge with 1/80000 epinephrine + Buccal infiltration of one 4% Articaine cartridge with 1/100000 epinephrine
16173832|NCT01593917|Device|Trifecta™ Valve|Aortic valve replacement with the Trifecta™ aortic bioprosthesis.
16173833|NCT01593878|Other|TV|test taken with TV on
16173834|NCT01593865|Procedure|BIMA Grafting|Both the left and the right internal mammary arteries are harvested and used to revascularize the two major coronary targets. Further coronary targets may be revascularized using either great saphenous vein or radial artery grafts, if present.
16173835|NCT01593865|Procedure|Left-only mammary artery grafting|These patients had only the left mammary artery harvested and used to revascularize the major coronary target. Great saphenous vein grafts and/or radial artery grafts were employed to revascularize the remaining targets.
16173836|NCT01593852|Radiation|Advanced image processing|Acquisition of x-ray images with reduced X-ray dose and advanced image processing
16173837|NCT01593852|Radiation|Regular image processing|Acquisition of x-ray images with regular X-ray dose and regular image processing
16173838|NCT01593826|Drug|Charcoal and Budesonide/formoterol Easyhaler 320/9 microg|2 inhalations as a single dose
16173839|NCT01593826|Drug|Charcoal and Symbicort Turbuhaler|2 inhalations as a single dose
16173840|NCT01593826|Drug|Budesonide/formoterol Easyhaler 320/9 microg|2 inhalations as a single dose
16173841|NCT01593826|Drug|Symbicort Turbuhaler forte|2 inhalations as a single dose
16173842|NCT01593800|Dietary Supplement|Bio-25|Bio-25 is an innovative formula containing 11 different strains of unique probiotic bacteria and over 25 billion active bacteria in each capsule. All participants will receive either Probiotics (Bio-25,will be provided by SupHerb) or placebo pills blindly for six months. One day prior to each visit, subjects will be asked to consume lactose, fructose and sorbitol free foods, in order to avoid high base line of hydrogen from the presence of unabsorbed carbohydrates. Subjects will also be asked not to smoke 24 hours prior to each visit.
16173843|NCT01593787|Drug|LCZ696|100 mg, 200 mg, 400 mg tablets.
16173844|NCT01593774|Drug|Melatonin|Tablet melatonin 3 mg/day at 9 pm as intervention group
16173845|NCT01593774|Drug|Placebo|Placebo (with the same shape and taste as melatonin) at 9 pm as control group
16173846|NCT01593761|Drug|CG400549|960mg QD at fed state approx 1 hour after meal
16173847|NCT01593748|Drug|Gemcitabine and Pazopanib|Gemcitabine 1000 mg/m2 by IV on day 1 and day 8 of a 21 day cycle. Pazopanib 800 mg by oral tablet daily for a 21 day cycle.
16173848|NCT01593748|Drug|Gemcitabine and Docetaxel|Gemcitabine 900 mg/m2 by IV on day 1 and day 8 of a 21 day cycle. Docetaxel 100 mg/m2 by IV on day 8 of a 21 day cycle.
16173849|NCT01593735|Drug|MK-2748|MK-2748 tablets, orally, once daily for 7 days, dose level dependent on Panel assignment
16173850|NCT01593735|Drug|Placebo|Placebo tablets, orally, once daily for 7 days
16173851|NCT01593722|Drug|Diethylcarbamazine|single dose
16173852|NCT01593722|Drug|Ivermectin|single dose
16173853|NCT01593696|Biological|Anti-Cluster of Differentiation (CD)19-Chimeric antigen receptor (CAR)|Cells extracted, followed by induction chemotherapy before Cluster of Differentiation (CD)19-Chimeric antigen receptor (CAR) infusion (dose escalation.)
16173854|NCT01593683|Behavioral|Psychological education program for nurses|Approximately 4 weekly one-hour group sessions led by study clinicians and 1 optional individual session with a single study clinician.
16173855|NCT01593670|Drug|Decitabine|administered intravenous (IV), 10 mg/m^2/day over 1 hour on days 1-5.
16173856|NCT01593670|Drug|Vorinostat|200 mg by mouth (PO) twice a day on days 6-15
16173857|NCT01593670|Biological|Interleukin-2|6 million Units subcutaneous (SQ) 3 times a week for 3 doses beginning day 17
16173858|NCT01593670|Other|Natural killer (NK) cells|infusion intravenously (IV) over 15 to 60 minutes day 17
16173859|NCT01593657|Other|Mindful Movement and Breathing program|Participate Mindful Movement and Breathing program with an experienced yoga instructor. All movements can be done while in a bed (e.g. turning head, shrugging shoulders, bending knees, etc). Each session lasts approximately 15 minutes.
16173860|NCT01593657|Other|Questionnaire administration|Collected at baseline (before surgery), before and after each YST session, and at follow-up (two days after surgery).
16173861|NCT01593657|Procedure|The Observer Mobility Scale|Conducted by nurse and study coordinator prior to surgery and two days after surgery to assess mobility. Will ask patient to turn, sit, stand and walk as they are able.
16173862|NCT01593657|Procedure|Volumetric Incentive Spirometry|Conducted twice before and after each Mindful Movement and Breathing program to measure lung function. Mean of the two readings used.
16173863|NCT01593644|Drug|adenosine + dipyridamole|adenosine / dipyridamole combination given intravenously as a slow bolus at low doses
16173864|NCT01593631|Dietary Supplement|Acid lactase|capsules cotaining 3300 FCC units of acid lactase
16173865|NCT01593631|Dietary Supplement|Acid lactase|capsules containing 9000 FCC of acid lactase
16173866|NCT01593631|Dietary Supplement|Lyoph. yoghurt bacteria|capsules containing 2 billion lyoph. yoghurt bacteria
16173867|NCT01593631|Dietary Supplement|Acid lactase plus yoghurt bacteria|Capsules containing 3300 FCC of acid lactase and 2 billion lyoph. yoghurt bacteria
16173868|NCT01593631|Dietary Supplement|Placebo|Capsules containing di-calcium-phosphate
16173869|NCT01593618|Behavioral|UMFollowUp|Web-based internet resource for self-reported treatment summaries and psychosocial and physical well-being.
16173870|NCT01593618|Other|Standard of Care|Patients will receive information regarding their diagnosis, treatments, and ongoing health needs from their provider, but will not be provided access to the website.
16173871|NCT01593605|Dietary Supplement|Resveratrol|A blend of low dose resveratrol and either leucine or HMB will be useful nutraceutical strategies for the control of elevated blood glucose in non-diabetic individuals with elevated fasting glucose. The proposed project is designed to evaluate this hypothesis by comparing the effects of resveratrol (50 mg)/leucine (1.11 g) administered twice daily (bid).
16173872|NCT01593605|Dietary Supplement|resveratrol /HMB|resveratrol (50 mg)/HMB (500 mg) twice daily (bid) with placebo on fasting blood glucose, glucose tolerance, insulin, C-peptide, glucagon, fructosamine and F2-isoprostanes in non-diabetic subjects with elevated fasting blood glucose.
16173873|NCT01593605|Other|Placebo treatment|Placebo - one tablet taken twice a day by mouth
16173874|NCT01593592|Dietary Supplement|Lactobacillus reuteri|Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and L. reuteri (is a mixture of L. reuteri DSM 17938 and L. reuteri ATCC PTA 6475, will be delivered a dose of 1x108 CFU each strain, means giving daily chewable tablet containing 2x108 CFU/day) for 2 weeks followed by L. reuteri for another 2 weeks.
16173875|NCT01593592|Dietary Supplement|Placebo|Will receive triple therapy (omeprazole 20 mg b.i.d., amoxicillin 1000 mg b.i.d, clarithromycin 500mg b.i.d) and a placebo (1.5 mg per dose as chewable tablets) for 2 weeks followed by placebo for another 2 weeks.
16173876|NCT01593592|Drug|Omeprazole|All patients will receive omeprazole 20 mg b.i.d for 2 week
16173877|NCT01593592|Drug|Amoxicillin|amoxicillin 1000 mg b.i.d for 2 weeks
16173878|NCT01593592|Drug|Clarithromycin|clarithromycin 500mg b.i.d for 2 weeks
16173879|NCT01593579|Behavioral|Autonomic Function Tests|Patients will undergo Autonomic Function testing (AFT) before and 8 hours after Akt Inhibition therapy. AFT includes: Supine & standing heart rate & blood pressure, 10 minute head up tilt, cardiac output, sinus arrhythmia, hyperventilation, sustained handgrip, valsalva manuever, and cold pressor test.
16173880|NCT01593579|Other|supine and standing catecholamines|patients will have blood drawn from supine and standing catecholamines.
16173881|NCT01593566|Drug|0.25% Bupivacaine|Femoral nerve block using 0.25% versus 0.5% bupivacaine
16173882|NCT01593566|Drug|0.5% Bupivacaine|Femoral nerve block using 0.25% versus 0.5% bupivacaine for analgesia after ACL reconstruction
16174942|NCT01585727|Procedure|TME|Total mesorectal excision
16173883|NCT01593553|Other|ECG screening for atrial fibrillation using intermittent ECG recorder|ECG screening for atrial fibrillation with intermittent ECG recording (Zenicor device) for 14 days. Introduction of anticoagulants in the case of atrial fibrillation.
16173884|NCT01593540|Device|metal-free interdental brush|one time per day
16173885|NCT01593540|Device|metal-core interdental brush|one time per day
16173886|NCT01593527|Drug|ACZ885|Canakinumab 150 mg s.c.
16173887|NCT01593527|Drug|Triamcinelone acetonide|Triamcinelone acetonide 40 mg i.m.
16173888|NCT01593514|Biological|MenACWY-CRM conjugate vaccine (Menveo, Novartis)|The MenACWY-CRM conjugate vaccine (Menveo, Novartis) is obtained by extemporaneous mixing just before injection of the lyophilized MenA component to be reconstituted with the MenCWY component. This vaccine is to be administered intramuscularly.
16173889|NCT01593514|Biological|MenACWY-PS polysaccharide vaccine, ( ACWYVax, GSK) and MenACWY-CRM conjugate vaccine (Menveo, Novartis)|The MenACWY-PS polysaccharide vaccine, ( ACWYVax, GSK) is obtained by reconstituting the purified ACWY polysaccharides with the 0.5 ml water for injection. This vaccine should be administered subcutaneously.The MenACWY-CRM conjugate vaccine (Menveo, Novartis) is obtained by extemporaneous mixing just before injection of the lyophilized MenA component to be reconstituted with the MenCWY component. This vaccine is to be administered intramuscularly.
16173890|NCT01593514|Biological|MenACWY-PS polysaccharide vaccine, ( ACWYVax, GSK) and MenACWY-CRM conjugate vaccine (Menveo, Novartis)|The MenACWY-PS polysaccharide vaccine, ( ACWYVax, GSK) is obtained by reconstituting the purified ACWY polysaccharides with the 0.5 ml water for injection. This vaccine should be administered subcutaneously.The MenACWY-CRM conjugate vaccine (Menveo, Novartis) is obtained by extemporaneous mixing just before injection of the lyophilized MenA component to be reconstituted with the MenCWY component. This vaccine is to be administered intramuscularly.
16173891|NCT01593514|Biological|1/5th dose MenACWY-PS polysaccharide vaccine, ( ACWYVax, GSK) and MenACWY-CRM conjugate vaccine (Menveo, Novartis)|To obtain the one-fifth dose of MenACWY-PS, 0.5ml of a full dose of MenACWY-PS will be reconstituted, and then 0.4ml will be discarded prior to subcutaneous injection. The MenACWY-CRM conjugate vaccine (Menveo, Novartis) is obtained by extemporaneous mixing just before injection of the lyophilized MenA component to be reconstituted with the MenCWY component. This vaccine is to be administered intramuscularly.
16173892|NCT01593514|Biological|Polysaccharide (subcutaneously)-conjugate|The MenACWY-PS polysaccharide vaccine, ( ACWYVax, GSK) is obtained by reconstituting the purified ACWY polysaccharides with the 0.5 ml water for injection.The MenACWY-CRM conjugate vaccine (Menveo, Novartis) is obtained by extemporaneous mixing just before injection of the lyophilized MenA component to be reconstituted with the MenCWY component. This vaccine is to be administered subcutaneously
16173893|NCT01593501|Dietary Supplement|vitamin D3|pharmaceutical grade D3
16173894|NCT01593488|Drug|liposomal cytarabine|given intrathecally in induction phase every 15 days until CSF response for up to 7 injections. Then it is given every 4 weeks during consolidation phase while patient awaiting bone marrow transplant. For those patients who are not candidates for a bone marrow transplant, the drug will be given every 3 months for 4 administrations (maintenance therapy)
16173895|NCT01593475|Radiation|Induction chemotherapy followed by CCRT|"Chemotherapy In one cycle (4-weeks), gemcitabine 1,000 mg/m2 will be given by 30-minute intravenous infusion on days 1, 8, and 15, and 1 hour infusion of CDDP was administered at a dose of 25 mg/m2 weekly diluted in 500 mL of normal saline to ensure adequate hydration 1 hour before the administration of gemcitabine. Gemcitabine 300mg/m2 will be given by 30-minute intravenous infusion weekly during CCRT will be started within 3 weeks after completion of 2 cycles of induction chemotherapy
~Radiotherapy
~- Total dose of PGTV and PCTV were 55 Gy, 22 fractions and 44 Gy, 22 fractions, respectively."
16173896|NCT01593462|Procedure|MRE (magnetic resonance enterography)|The MRE will take approximately 60 minutes to complete. Enrolled subject will have MRE imaging performed at about 4 weeks after treatment for small bowel crohn's disease begins, and when the treatment ends or changes or at 6 months, whichever comes first. The 4 week MRE will be for research purposes only, the treatment end,change or 6 month MRE may or may not be ordered by the treating physician as part of your routine care. If one is not ordered by the treating physician, the subject will have one performed because of the research study.
16173897|NCT01593462|Procedure|The Ultrasound scan, (UEI) Ultrasound Elastography Imaging with ARFI (acoustic radiation force impulse)|The US UEI will take about 60 minutes to perform. This exam will be performed by 2 different radiologists and you will have this completed 5 times over the course of the study. This imaging will be performed with the subject drinking oral contrast material. The US, UEI will be completed at baseline, 2 weeks, 4 weeks, 3 months and at treatment end/change or 6 months, whichever comes first.
16173898|NCT01593462|Behavioral|Study Questionnaires|"The subject and their parent will be asked to answer questionnaires 2 weeks after the first MRE and US exams and again after the last imaging examinations are performed at treatment end/change or 6 months, whichever comes first.
~A Pediatric Crohn Disease Activity Index Assessment will be performed at baseline, 2 weeks, 4 weeks, 3 months, and at treatment end/change or 6 months, whichever comes first. The study questionnaires should take no longer than 10 to 40 minutes to complete."
16173899|NCT01593449|Behavioral|Community-based social networking intervention|Participation in this study lasts for 7 months and includes a baseline visit, an orientation visit, the 6 month intervention, and a 6 month assessment visit.
16173900|NCT01593436|Behavioral|mindfulness training|mindfulness interventions for 8 weeks for a group of menopausal insomniacs
16173901|NCT01593423|Behavioral|plant-based Homestead Food Production|The village model farm will be provided with the necessary inputs to establish their farm including saplings seeds etc.
16173902|NCT01593423|Behavioral|Homestead Food Production plus small pond aquaculture|In the case of the aquaculture arm a pond will be dug if there is not an existing pond and fingerlings and brood stocks will be provided. Hatcheries will be established if there is not one within a reasonable distance of the farms.
16173903|NCT01593423|Behavioral|a comparison group|No intervention.
16173904|NCT01593410|Drug|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
16173905|NCT01593410|Drug|Dexamethasone|Cycle 1: 40 mg oral dexamethasone once daily on Days 8, 15, and 22. Cycle 2 and beyond: 40 mg oral dexamethasone once daily on Days 1, 8, 15, and 22
16173939|NCT01593163|Drug|Ibuprofen EchoG|Infants in the experimental group (echoG treatment) received additional doses of ibuprofen only if PDA was still ≥ 1.5 mm at the time of the corresponding ibuprofen dose.
16176459|NCT01573910|Drug|Ofloxacin ophthalmic solution, 0.3%|
16173906|NCT01593397|Drug|Propofol and Fentanyl administration|Propofol will be administered to all patients via infusion at a dose of 2 mg/kg lean body weight/minute. The infusion will stop once loss of consciousness is reached. Fentanyl will be administered via target controlled infusion to achieve a plasma concentration of 2 ng/ml.
16173907|NCT01593371|Drug|Metformin|Metformin 1000 mg fixed dose, twice daily (500 mg tablets x 2)
16173908|NCT01593371|Drug|Pioglitazone|Pioglitazone 30 mg fixed dose, twice daily (15 mg tablets x 2)
16173909|NCT01593345|Other|Mobility self-management with Mentor|will be offered an evaluation and treatment plan supervised by a qualified physiotherapist, accompanied by written and visual material to enhance mobility self-management skills, supported by telephone mentoring by physiotherapy students in the Professional Master's program. The components of the mobility self-management program will target skill enhancement of each senior to identify their functional limitations, set realistic goals for mobility improvement, develop a mobility action plan, carry out the plan, and then re-assess their function and mobility. Mobility self-assessment, personalized goals, and the action plan will be incorporated into a personalized workbook that the senior can use to monitor their function profile and serve as a communication aid during health care encounters.
16173910|NCT01593345|Other|Mobility self-management with guidebook|will be mailed an exercise guide targeting the key mobility limitations common in the elderly (range of motion, arm, leg, and core strength, and breathing). This guide has been developed and has been pilot tested on a small number of seniors and has been shown to be acceptable and feasible.
16173911|NCT01593332|Drug|Rituximab|two 500 mg rituximab infusions 2 weeks apart
16173912|NCT01593332|Drug|Rituximab|500mg,two times with two weeks interval
16173913|NCT01593319|Drug|Ropivacaine|Local injection (fascia iliaca block) using 150 mg ropivacaine
16173914|NCT01593319|Drug|Natrium chloride|Placebo injection of Natrium chloride solution
16173915|NCT01593306|Drug|Paclitaxel, Cisplatin|intravenous paclitaxel infusion at 50mg/m2/week and cisplatin at 30mg/m2/week for 5 weeks. if supplement Chemo Radiotherapy is required then similar dose per week for 2 more weeks.
16173916|NCT01593306|Drug|Cisplatin|intravenous infusion of cisplatin 40mg/m2/week for 5 weeks. if I/C Brachytherapy is not feasible then supplement CRT given with similar dose of cisplatin for 2 more cycles.
16173917|NCT01593293|Drug|PemCarbo|Pemetrexed 500mg/m2, Carboplatin AUC5 intravenously q 3 weeks for 4 cycles, followed by pemtrexed 500mg/m2 q 3 weeks for maintenance therapy
16173918|NCT01593293|Drug|Pem only|Pemetrexed 500mg/m2 intrvenously q 3 weeks till progression or unacceptable toxicity.
16173919|NCT01593280|Device|TAP catheter|dosed with 20ml of Ropivacaine 0.5% at that time. Double lumen pump containing 700 ml of the Ropivacaine 0.2% will be attached to the TAP catheters in the recovery room. The time that this occurs will be recorded in the eMAR. The catheters will run at 7cc/hr/side for 50 hrs.
16173920|NCT01593280|Drug|intrathecal morphine|0.3 mg
16173921|NCT01593267|Procedure|coil embolization|Subjects randomized to endovascular therapy will be treated by one of two neurosurgeons expert in such treatment. All endovascular treatments will be accomplished using accepted techniques.
16173922|NCT01593267|Procedure|clip occlusion|Subjects randomized to surgical therapy will receive treatment from one of two neurosurgeons expert in surgery for ruptured aneurysms.
16173923|NCT01593254|Drug|Imatinib|
16173924|NCT01593254|Drug|Dasatinib|
16173925|NCT01593241|Drug|Carboplatin|Stage IIA: 1 infusion Carboplatin AUC7 followed by 15 x 2 Gy involved node radiotherapy Stage IIB: 1 infusion Carboplatin AUC7 followed by 18 x 2 Gy involved node radiotherapy
16173926|NCT01593241|Radiation|Involved node RT|Involved node RT
16173927|NCT01593228|Drug|Iniparib (SAR240550/BSI-201)|"Pharmaceutical form:Solution
~Route of administration: Intravenous"
16173928|NCT01593228|Drug|Carboplatin|"Pharmaceutical form:Solution
~Route of administration: Intravenous"
16173929|NCT01593228|Drug|Doxorubicin HCL liposome injection|"Pharmaceutical form:Solution
~Route of administration: Intravenous"
16173930|NCT01593228|Drug|Gemcitabine|"Pharmaceutical form:Solution
~Route of administration: Intravenous"
16173931|NCT01593228|Drug|Irinotecan|"Pharmaceutical form:Solution
~Route of administration: Intravenous"
16173932|NCT01593228|Drug|Paclitaxel|"Pharmaceutical form:Solution
~Route of administration: Intravenous"
16173933|NCT01593228|Drug|Topotecan|"Pharmaceutical form:Solution
~Route of administration: Intravenous"
16173934|NCT01593215|Drug|Yohimbine|Yohimbine capsule
16173935|NCT01593202|Behavioral|Dialectical behavior therapy|"16 weeks of Dialectical behavior therapy with one weekly session of individual therapy, one weekly session of multifamily skills training group, telephone coaching and ancillary family therapy and/or pharmacological treatment as needed.
~The treatment has been developed by Marsha Linehan (Linehan, 1993a; 1993b)and adapted for adolescents by Alec Miller (Miller, Rathus & Linehan, 2007). Individual DBT therapists have been trained by drs Alec L Miller and Sarah K Reynolds and have a minimum of one year clinical practise as DBT therapists. The therapists are organised in two consultation teams supervised on a bimonthly basis throughout the entire study by drs Miller and Reynolds respectively."
16173936|NCT01593202|Behavioral|Enhanced usual care|16 weeks of outpatient treatment in child and adolescent psychiatric clinics in Oslo, on average one weekly session of individual therapy and ancillary supportive. family and/or pharmacological treatment as needed.
16173937|NCT01593189|Behavioral|KITS Program|This is a 4-month psychosocial intervention for children with developmental disabilities and behavior problems who are entering kindergarten and their caregivers. The intervention begins in the summer before kindergarten. The KITS intervention consists of: (a) child school readiness play groups to facilitate the development of self-regulatory, social, and early literacy skills (2 times per week in summer, 1 times per week in the fall); and (b) a bi-monthly psychoeducational support group to promote parent involvement in the child's early literacy and schooling and the use of effective parenting techniques
16173938|NCT01593176|Procedure|Placement of RSA beads|At the time of surgery sets of up to 9 RSA beads will be implanted on sides of the main fractures lines with the use of the inserter instrument and the image intensifier. In AO/OTA type 33A fractures two sets will be implanted - one in the femoral shaft and one in the distal femoral epiphysis. In AO/OTA type 33C fractures with an extra fracture line through the epiphysis, three sets will be implanted - one in the femoral shaft, one in the main lateral condyle segment and one in the main medial condyle segment. No beads will be planted in comminuted bone fragments. The fracture will then be plated with a LISS plate as it normally would.
16173940|NCT01593163|Drug|Standard ibuprofen treatment|Infants received 3 doses of ibuprofen at 24-hour intervals, independently of ductal size, as long as additional doses were not contraindicated.
16173941|NCT01593150|Drug|Pradaxa|Pradaxa for 3 weeks prior to DC
16173942|NCT01593150|Procedure|TEE|Transesophageal echo to exclude LAA thrombus, followed by early DC.
16173943|NCT01593150|Other|Compare TEE guided cardioversion to Dabigatran + DC cardioversion|compare the two groups, TEE followed by early DC cardioversion with Dabigatran for 3 weeks followed by DC cardioversion.
16173944|NCT01593137|Drug|Liraglutide + metformin|"Liraglutide 1.8 mg/day + metformin >1500mg/day. Liraglutide will be administered once daily by subcutaneous injection, either in the abdomen, thigh or upper arm.
~Patients will continue on metformin therapy as they were prescribed before enrolment."
16173945|NCT01593137|Drug|Glimepiride + metformin|"Glimepiride 4 mg/day + metformin >1500 mg/day. Tablets should be swallowed whole with some liquid before or during a substantial breakfast or, if none is taken, shortly before or during the first main meal.
~Patients will continue on metformin therapy as they were prescribed before enrolment."
16173946|NCT01593124|Drug|Imiquimod|Participants first have sampling in the follicular and luteal phases of the menstrual cycle. Then participants receive 4 doses of HEC placebo gel in the luteal phase. Finally, participants are randomized to the order of IMiquimod, 2 doses vaginally, in the luteal phase and nonoxynol-9, 4%, 4 doses vaginally in the luteal phase.
16173947|NCT01593124|Other|Placebo|Participants first have sampling in the follicular and luteal phases of the menstrual cycle. Then participants receive 4 doses of HEC placebo gel in the luteal phase. Finally, participants are randomized to the order of IMiquimod, 2 doses vaginally, in the luteal phase and nonoxynol-9, 4%, 4 doses vaginally in the luteal phase.
16173948|NCT01593124|Drug|Nonoxynol-9|Participants first have sampling in the follicular and luteal phases of the menstrual cycle. Then participants receive 4 doses of HEC placebo gel in the luteal phase. Finally, participants are randomized to the order of IMiquimod, 2 doses vaginally, in the luteal phase and nonoxynol-9, 4%, 4 doses vaginally in the luteal phase.
16173949|NCT01593111|Other|Environmental Intervention|Home-based environmental intervention
16173950|NCT01593085|Behavioral|interview with a doctor for evaluating suicide risk|"patients with cancer in palliative cares An interview and will be offered to this patient during his hospitalization to be held (with the collection of personal and family psychiatric history of the patient, family and social context, the assessment of chronic pain and fatigue and quality of life,assessment of anxiety, Evaluation of symptoms of depression,asessment of suicide risk)
~--------------------------------------------------------------------------------"
16173951|NCT01593072|Drug|AVI-7537|"Cohort 1: AVI-7537 at 4.5 mg/kg IV; Cohort 2: AVI-7537 at 9 mg/kg IV;Cohort 3: AVI-7537 at 15 mg/kg IV; Cohort 4: AVI-7537 at 30 mg/kg IV
~The amount of AVI-7537 required to administer the required dose will be diluted to a volume of approximately 150 mL with normal saline solution (NSS) and given by IV infusion over 30 minutes once a day for 14 days. Infusions will be administered at approximately the same time each day."
16173952|NCT01593072|Other|Normal Saline Solution (NSS)|Normal Saline Solution (NSS)
16173953|NCT01593046|Drug|GSK1265744 Oral|30mg tablet
16173954|NCT01593046|Drug|GSK1265744 LAP 800mg intramuscular injection|800mg Loading dose given at month 1 dose
16173955|NCT01593046|Drug|GSK1265744 LAP 200mg subcutaneous injection|200mg maintenance dose give at months 2 - 4
16173956|NCT01593046|Drug|GSK1265744 LAP 200mg intramuscular injection|200mg maintenance dose given at months 2 - 4
16173957|NCT01593046|Drug|GSK1265744 LAP 400mg intramuscular injection|400mg maintenance dose given at month 2 - 4
16173958|NCT01593046|Drug|TMC278 LA 1200mg intramuscular injection|1200mg Loading dose given at month 3
16173959|NCT01593046|Drug|TMC278 LA 600mg intramuscular injection|600mg Loading dose given at month 4
16173960|NCT01593046|Drug|GSK1265744 LAP 800mg intramuscular injection|800mg dose given quarterly (once every) 12 weeks
16173961|NCT01593033|Dietary Supplement|Fish oil and Micronutrient Supplementation|"0.9 mL highly purified fish oil (200 mg docosahexaenoic acid, 300 mg eicosapentaenoic acid) to be given daily for 6 months
~1 RDA of all known micronutrients needed for normal child growth in powder form to be given daily for 6 months"
16173962|NCT01593033|Dietary Supplement|Micronutrient Supplement|1 RDA all known micronutrients needed for normal child growth to be given daily in powder form for 6 months 0.9 mL palm oil given daily for 6 months
16173963|NCT01593033|Drug|Placebo|10 g sugar in granule form to be given daily for 6 months 0.9 mL palm oil to be given daily for 6 months
16173964|NCT01593020|Drug|Paclitaxel|80 mg/m2 by vein over 1 hour on Days 1, 8, and 15 of each 21-day cycle.
16173965|NCT01593020|Drug|Eribulin|1.4 mg/m2 by vein over 2-5 minutes on Days 1 and 8 of each 21-day study cycle.
16173966|NCT01593020|Drug|5-Fluorouracil|500 mg/m2 by vein on day 1 for 4 cycles (21 day cycle) at preference of treating physicians.
16173967|NCT01593020|Drug|Epirubicin|100 mg/m2 by vein on day 1 for 4 cycles (21 day cycle) at preference of treating physicians.
16173968|NCT01593020|Drug|Cyclophosphamide|500 mg/m2 by vein on day 1 for 4 cycles (21 day cycle) at preference of treating physicians.
16173969|NCT01593020|Drug|Doxorubicin|50 mg/m2 by vein on day 1, over 72 hour continuous infusion or intravenous bolus, for 4 cycles (21 day cycle) at preference of treating physicians.
16173970|NCT01593007|Other|Inspiratory muscle training|All participants were instructed to use a Threshold® trainer for 30min a day, seven times a week over 12 consecutive weeks.10 Patients in the Control Group used a Threshold ® device without resistance, making them blind to the treatment. For the treatment group, inspiratory resistance of the Threshold® trainer was 30% of MIP, adjusted on a weekly basis to remain constant.
16173971|NCT01593007|Other|Control group|Patients from the control group were also assessed weekly to ensure homogenization of the learning effect for the manometer maneuver.
16174012|NCT01592708|Other|Antiemetic anesthesia protocol|Intervention group consisted of patients undergoing maxillary osteotomy who received an antiemetic protocol designed to provide multimodal antiemetic therapy which have been shown to help prevent and/or treat postoperative nausea, combined with the elimination of anesthetic factors that may contribute to postoperative nausea and vomiting.
16174013|NCT01592695|Drug|Nicotine replacement therapy - transdermal nicotine patch|Medication selection will be determined based on individual participant preferences, medical history, and contraindications.
16174357|NCT01590420|Device|CPAP S8- Scape / Resmed|The pressure for treatment is according to PSG titration
16173972|NCT01592994|Behavioral|RHANI WIves|The RHANI Wives intervention included four household individual sessions and two small group community sessions delivered over 6-9 weeks. The intervention was based on Social Cognitive Theory (SCT)10 and the Theory of Gender and Power (TGP). SCT application supported focus on HIV/STI knowledge and condom skills building, as well as safer sex social norms and motivation. TGP guided the intervention focus on problem solving and skills building toward marital communication; embedded in this was gender equity counseling and support. The TGP approach allowed women to take a more active and assertive stance with husbands. Group sessions reinforced individual session knowledge and skills building and provided local social support.
16173973|NCT01592981|Drug|Bortezomib|1.6 mg/m2 subcutaneous bortezomib on days1, 8 and 15 of 28 days cycle
16173974|NCT01592981|Drug|Cyclophosphamide|"Cyclophosphamide:250 mg/sq m, oral, days 1, 8 and 15 of each cycle in the experimental arm.
~Cyclophosphamide:250 mg/sq m, oral, days 1, 2 and 3 of each cycle in the control arm."
16173975|NCT01592981|Biological|Rituximab|Rituximab: 375 mg/m2 i.v. infusion; days 1, 8, 15 and 22 of cycles 2 and 5 only
16173976|NCT01592981|Drug|Fludarabine|Fludarabine: 40 mg/sq m, oral, days 1, 2 and 3
16173977|NCT01592968|Other|Cognitive Assessment|Ancillary studies
16173978|NCT01592968|Other|Quality-of-Life Assessment|Ancillary studies
16173979|NCT01592968|Radiation|Stereotactic Radiosurgery|Undergo SRS
16173980|NCT01592968|Radiation|Whole-Brain Radiotherapy|Undergo WBRT
16173981|NCT01592955|Device|EYEOP1|Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP1 device
16173982|NCT01592942|Device|Histoacryl|cyanoacrylate glue fixation of mesh 1 ml
16173983|NCT01592942|Device|Progrip|self-gripping mesh
16173984|NCT01592942|Device|sutures (prolene 3-0)|non-absorbable suture fixation 3-0
16173985|NCT01592929|Radiation|Magnetic Resonance imaging|11 MRI scans per subject will be taken, one for each mouthpiece design of an inhaler.
16173986|NCT01592929|Other|Pharyngometry|Pharyngometry will be carried out in supine and upright position. 11 different mouthpieces will be evaluated in both positions.
16173987|NCT01592929|Radiation|Computed Tomography scan|One low dose CT scan of the upper airway will be taken. The scan will be taken at normal inhalation through a mouthpiece with moderate resistance.
16173988|NCT01592929|Radiation|Cone Beam Computed Tomography scan|One CBCT scan of the upper airway will be taken. The scan will be taken at normal respiration through a mouthpiece with moderate resistance.
16173989|NCT01592929|Other|Dental impressions|Dental impressions will be taken. These will be optically scanned before registration in the 3D imaging modalities.
16173990|NCT01592903|Genetic|Laparoscopic myomectomy. Following analysis and proliferation of cells isolated from removed human leiomyoma.|"Obtention of one part of removed human leiomyoma after surgery and maintained in 4ºC until procedures.
~Sample digestion through controlled enzymes.
~Isolated the Side Population from leiomyoma cell suspension by Flow cytometry .
~Culture of these cells.
~Morphological and genetic characterization.
~Assessment of pluripotent potential from isolated cells.
~Analysis of the degree of functionality."
16173991|NCT01592890|Drug|RO4917523|[14C]-labeled RO4917523, single oral dose
16173992|NCT01592890|Drug|RO4917523|[13C]-labeled RO4917523, single intravenous tracer dose
16173993|NCT01592864|Drug|Stannous Fluoride|dentifice
16173994|NCT01592864|Drug|Sodium Monofluorophosphate|dentifrice
16173995|NCT01592851|Drug|Stannous Fluoride|dentifrice containing stannous fluoride
16173996|NCT01592851|Drug|Sodium Monofluorophosphate|dentifrice containing Sodium Monofluorophosphate
16173997|NCT01592838|Other|Data collection|The participating centre will be requested to generate a coded list of all hospitalisations taken place during the study period (June 1st 2004- May 31st 2010) and analysed for changes in hospital pattern pre- versus post-rotavirus vaccination, in children aged ≤15 years.
16173998|NCT01592812|Device|electrical muscle stimulation|Duration of the stimulation 20 minutes
16173999|NCT01592799|Procedure|Throat swab and/or nasopharyngeal swab|Samples will be tested to quantify the inpatient and ER visits burden of laboratory-confirmed influenza.
16174000|NCT01592799|Other|Data collection|Log Sheet will be used to collected data on a monthly basis for the following age groups: < 6 months; 6-23 months; 24-59 months; > 5 years.
16174001|NCT01592786|Drug|Memantine Hydrochloride (HCl)|Memantine extended release 3-mg capsules; the dosages studied ranged from 3 - 15 mg/day; weight based dosing in 4 weight groups; oral administration. Dosing is once daily for up to 48 weeks.
16174002|NCT01592773|Drug|Memantine Hydrochloride (HCl)|"During the 6-week double-blind dosing titration/maintenance period, Memantine extended-release 3-mg and 6-mg capsules; oral administration. Dosing was once daily.
~During open-label treatment: Memantine extended-release 3mg capsules; oral administration. The maximum target dosage was identified during the prior studies for each patient. Dosing was once daily."
16174003|NCT01592760|Device|air-Q SP|air-Q SP placement for airway maintenance.
16174004|NCT01592760|Device|air-Q|air-Q placement for airway maintenance.
16174005|NCT01592760|Device|i-gel|i-gel placement for airway maintenance.
16174006|NCT01592747|Drug|Memantine Hydrochloride (HCl)|Extended Release Dose ranging from 3-15mg/day; administered orally
16174007|NCT01592747|Drug|Memantine Hydrochloride (HCl)|Extended Release Dose ranging from 3mg every other day to 6mg/day; administered orally.
16174008|NCT01592747|Drug|Placebo capsules|Once daily, oral administration.
16174009|NCT01592734|Drug|Polyethylene glycol with electrolytes|"Constipation treatment: 1-4 sachets/day according to the patient age. 1 sachet contains 6.9 g PEG-EL. Treatment period: 4 weeks.
~Faecal impaction resolution: 4 sachets as initial dose and increasing 2 sachets a day until resolution or up to 7 days."
16174010|NCT01592734|Device|Polyethylene glycol|"Constipation: 0.7 g/kg/day in 2 divided doses for children of less than 20 kg. For children > 20 kg the daily dose was up to PEG 30 g daily. Treatment period: 4 weeks.
~Faecal impaction resolution: 1.5 g/kg/day in 2 doses until resolution or up to 6 days."
16174011|NCT01592721|Biological|EGFR Antisense DNA|EGFR AS will be administered by direct intratumoral injection using direct visualization, endoscopy, or imaging-guidance (ultrasound) as clinically determined. Patients will receive a total of up to 4 weekly intratumoral injections of EGFR antisense (or less if there is no identifiable tumor) starting 2 weeks prior to radiation. Patients will receive standard radiation 70 Gy/200 cGy/daily, 5 days/week, with concurrent cetuximab 250 mg/m2, after a loading dose of 400 mg/m2 2 weeks prior to starting radiation.
16174014|NCT01592695|Behavioral|Tailored behavioral intervention|Participants will receive a standard six session cognitive behavioral intervention for smoking cessation combined with supplemental treatment modules based on individual need and preference.
16174015|NCT01592695|Behavioral|Tobacco quit line referral|Participants assigned to this condition will receive a referral to their state tobacco quit line. The specific behavioral treatment that is provided will differ slightly depending upon the services available through the participant's state of residence.
16174016|NCT01592695|Drug|Nicotine replacement therapy - nicotine gum|Medication selection will be determined based on individual participant preferences, medical history, and contraindications
16174017|NCT01592695|Drug|Nicotine replacement therapy - nicotine lozenge|Medication selection will be determined based on individual participant preferences, medical history, and contraindications
16174018|NCT01592695|Drug|Bupropion Sustained Release|Medication selection will be determined based on individual participant preferences, medical history, and contraindications
16174019|NCT01592695|Drug|Varenicline|Medication selection will be determined based on individual participant preferences, medical history, and contraindications
16174020|NCT01592695|Drug|Combination pharmacotherapy - transdermal nicotine patch + nicotine gum|Medication selection will be determined based on individual participant preferences, medical history, and contraindications
16174021|NCT01592695|Drug|Combination pharmacotherapy - transdermal nicotine patch + nicotine lozenge|Medication selection will be determined based on individual participant preferences, medical history, and contraindications
16174022|NCT01592695|Drug|Combination pharmacotherapy - transdermal nicotine patch + bupropion|Medication selection will be determined based on individual participant preferences, medical history, and contraindications
16174023|NCT01592695|Behavioral|Alcohol use risk reduction|Participants engaging in risky alcohol use may receive this six-session telephone-based behavioral intervention for reducing alcohol use.
16174024|NCT01592695|Behavioral|Behavioral activation for the treatment of depression|Participants with elevated depressive symptoms may receive this six-session telephone-based behavioral activation intervention.
16174025|NCT01592695|Behavioral|Behavioral management of post-cessation weight gain|Participants with concerns about gaining weight after quitting smoking may receive this six-session telephone-based behavioral self-management intervention designed to help attenuate post-cessation weight gain.
16174026|NCT01592682|Behavioral|Smokefree counseling|Smokefree counseling intervention involves group education sessions, follow-up phone calls, tobacco exposure lab report. Comparison is usual care with referral to local in-language smoking cessation services including quitline.
16174027|NCT01592669|Procedure|passive leg raising|bilateral PLR was achieved by raising the legs of patient
16174028|NCT01592656|Radiation|Functional Respiratory Imaging|CT-scan of thorax. At baseline, after 1 month and after 6 months.
16174029|NCT01592656|Other|Lung compliance measurement|At baseline
16174030|NCT01592656|Device|Non-invasive ventilation (Respironics)|Long-term non-invasive ventilation, starting at baseline until 6 months. At baseline the patients should have persisting hypercapnia (pCO2 > 45 mmHg) under optimal conservative treatment other than NIV. The patients can be hospitalised or being treated at home at inclusion.
16174031|NCT01592643|Device|Eye Shield|The thin shield is made of silicone. The materials used to make the corneal shield all have a history of use in medical devices, contact lenses, and/or corneal shields and have been used safely in the eye.
16174032|NCT01592630|Drug|0.2% ropivacaine|On-Q pumps containing 0.2% ropivacaine to be attached to TAP catheters
16174033|NCT01592630|Drug|Saline|On-Q pumps containing saline to be attached to TAP catheters
16174034|NCT01592617|Drug|S-488410|In multicenter HLA-blinded open study, patients will be vaccinated subcutaneously once a week with S-488410 (S-488401, S-488402, S-488403, 1mg each).
16174035|NCT01592604|Device|Compressive bandage|Compressive below knee bandage for 4 weeks in group A
16174036|NCT01592604|Device|Below knee walking cast|Below knee walking cast for 4 weeks
16174037|NCT01592578|Procedure|Ligation and Cyanoacrylate|Patients will be treated with ligation for esophageal varices and cyanoacrylate for gastric varices when necessary.
16174038|NCT01592578|Procedure|Ligation plus Sclerotherapy and Cyanoacrylate Group|Patients will receive sclerotherapy after first ligation for esophageal varices and cyanoacrylate for gastric varices when necessary
16174039|NCT01592565|Other|Diagnostic Cardiac Imaging|Cardiac Magnetic Resonance (CMR) offers superior image quality compared to echocardiography and nuclear imaging, and the ability to image both function and perfusion. Combining the superior image quality of CMR with the diagnostic information provided by exercise stress could result in a new, more accurate modality for diagnosing and evaluating coronary artery disease. This project is expected to show that CMR is at least equivalent to nuclear stress imaging and could potentially replace it in many instances, eliminating the need for radioisotope administration and the associated exposure of patients to ionizing radiation.
16174040|NCT01592526|Other|Endotoxin|Bolus injection of LPS 2 ng/kg IV at time = 2 hours (Study day A).
16174041|NCT01592526|Other|Endotoxin + Nicotine|Transdermal application of nicotine patch applied at time = -8 hours (midnight the day before Study day B) + bolus injection of LPS 2 ng/kg at time = 2 hours (Study day 2)
16174042|NCT01592513|Device|BIS monitor|"BIS is a monitor of anesthetic depth approved by the FDA. It incorporates time-domain, frequency-domain and bi-spectral analysis of the EEG. This analysis is displayed as a dimensionless number between zero (deep anesthesia) and 100 (awake).
~BIS values between 80-90 represent values corresponding to light/moderate sedation.
~BIS is a valuable tool for assessing the depth of sedation and guiding the administration of sedative drugs."
16174043|NCT01592500|Drug|MOD-4023|Once weekly subcutaneous injection
16174044|NCT01592500|Drug|Somatropin|Once daily subcutaneous injection of Genotropin
16174045|NCT01592448|Behavioral|Active Ingredient Icon|"Enhanced bottles will have a symbol, or icon, designed to draw attention to active ingredient information. The icon is a black hexagon containing two letters denoting the active ingredient of the medication (i.e. Ac for acetaminophen). Over-the-counter bottles will have the icon placed on the front of the bottle next to active ingredient information and on the back of the bottle in the drug facts to the left of the active ingredient information. Prescription bottles will have the icon placed below the directions for how to take the medication and will be accompanied by a brief statement indicating the medicine contains acetaminophen."
16174046|NCT01592422|Biological|Autologous cytokine-induced killer cell|Subjects receive autologous cytokine-induced killer cell infusion every month in the absence of disease progression or unacceptable toxicity.
16174047|NCT01592422|Other|Best Supportive Care|Best Supportive Care in the absence of disease progression
16174048|NCT01592409|Drug|delta-9-tetrahydrocannabinol|A single cannabis cigarette (potency 12.5% THC) will be given to participants to smoke over a 10 minute period, ad lib. If the cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose.
16174049|NCT01592409|Drug|Placebo|A single placebo cannabis cigarette (0% THC) will be given to participants to smoke over a 10 minute period, ad lib. If the cigarette is not smoked in its entirety, the remainder will be weighed to estimate dose (as this is a double-blind study).
16174050|NCT01592396|Biological|Tralokinumab 300 mg|Participants aged 12 to 14 years and 15 to 17 years will receive a single dose of tralokinumab (CAT-354) 300 mg, subcutaneously on Day 1.
16174051|NCT01592383|Drug|erlotinib hydrochloride|Given PO
16174052|NCT01592370|Biological|Nivolumab|Administered by intravenous (IV) infusion
16174053|NCT01592370|Biological|Ipilimumab|Administered by IV infusion
16174054|NCT01592370|Biological|Lirilumab|Administered by IV infusion
16174055|NCT01592370|Biological|Daratumumab|Administered by IV infusion
16174056|NCT01592370|Drug|Pomalidomide|Administered PO
16174057|NCT01592370|Drug|Dexamethasone|Administered PO and by IV infusion
16174058|NCT01592357|Behavioral|Tai Chi exercise|A short and simple 8-forms Tai Chi routine will be used in this study. This routine has been previously standardized and field tested. Participants will be coached, by a certified Tai Chi instructor, in practicing the proper mechanics of executing each of the eight physical movements comprising the 8-forms of Tai Chi. A brief 5 minute period of walking calisthenics pertinent to Tai Chi movements, postures and diaphragmatic breathing will take place before training to warm up and after training to cool down. The Tai Chi training will be 2 times a week and the total exercise time, including warm-up and cool down, will be 50 minutes for each session. Over a period of 12 weeks, the participants will learn all 8-forms and continue practicing them for the final 12 weeks of the training period.
16174059|NCT01592357|Behavioral|Sham Exercise|"The sham exercise (control) group will be involved in low-intensity stretching exercises two times per week. These exercises will be designed as a sham exercise condition. A brief 5 minute period of walking will take place before the sham exercise to warm up and after the sham exercise to cool down. Sham exercise sessions will include stretching exercises of the neck, trunk and extremities. The total exercise time for the sham exercise group will be 50 minutes and participants will meet 2 times per week for a period of 24 weeks."
16174060|NCT01592344|Device|StimRouter - active stimulation|"The stimulation program settings for this arm are as follows:
~Stim Settings
~Waveform: Symmetric or Asymmetric
~Phase Duration: 100-250 µsec
~Pulse Rate: 50-100 Hz
~Intensity: 0-30mA Time Settings
~Constant Stim: On
~Total Time: 6 hour"
16174061|NCT01592344|Device|StimRouter - Control|"The stimulation program settings for this arm are as follows:
~Stim Settings
~Waveform: Symmetric or Asymmetric
~Phase Duration: 200 µsec
~Pulse Rate: 1 Hz
~Intensity: 0 mA Time Settings
~Constant Stim: On
~Total Time: 6 hour"
16174062|NCT01592331|Drug|Placebo|Single oral dose
16174063|NCT01592331|Drug|RO5508887|Single oral dose
16174064|NCT01592318|Drug|danoprevir|Fixed dose combination tablet with ritonavir, single oral dose
16174065|NCT01592318|Drug|danoprevir|Reference tablet, single oral dose
16174066|NCT01592318|Drug|ritonavir|Fixed dose combination tablet with danoprevir, single oral dose
16174067|NCT01592318|Drug|ritonavir|Reference tablet, single oral dose
16174068|NCT01592305|Drug|atazanavir|multiple oral doses
16174069|NCT01592305|Drug|danoprevir|multiple oral doses
16174070|NCT01592305|Drug|ritonavir|multiple oral doses
16174071|NCT01592305|Drug|tenofovir disoproxil fumarate|single oral doses
16174072|NCT01592292|Drug|Rituximab|Rituximab as per physician's discretion.
16174073|NCT01592292|Drug|Adalimumab|Adalimumab as per physician's discretion.
16174074|NCT01592292|Drug|Etanercept|Etanercept as per physician's discretion.
16174075|NCT01592292|Drug|Infliximab|Infliximab as per physician's discretion.
16174076|NCT01592279|Drug|liraglutide|
16174077|NCT01592279|Drug|Insulin injections|
16174078|NCT01592253|Drug|Sirolimus|Beginning on day, an initial maintenance dose of 2mg/day should be given. A trough level should be obtained between days 3 and 8, and the daily dose of sirolimus should be adjusted thereafter.
16174079|NCT01592240|Drug|PBO|Placebo Q28d
16174080|NCT01592240|Drug|200mg PF-04950615 (RN316)|PF-04950615 200 mg, Q28d
16174081|NCT01592240|Drug|300mg PF-04950615 (RN316)|PF-04950615 300 mg, Q28d
16174082|NCT01592240|Drug|PBO|Placebo, Q14d
16174083|NCT01592240|Drug|PF-04950615|PF-04950615 50mg, Q14d
16174084|NCT01592240|Drug|PF-04950615|PF-04950615 100 mg, Q14d
16174085|NCT01592240|Drug|PF-04950615|PF-04950615 150mg, Q14d
16174086|NCT01592227|Drug|Marketed paracetamol|Marketed paracetamol
16174087|NCT01592227|Drug|Experimental paracetamol formulation|Experimental paracetamol formulation
16174088|NCT01592214|Other|Placebo|Placebo: 4% Klucel® gel formulation, concentration 0, total daily volume 1.8 ml, 3 doses 8 hours apart on Day 1 and 1.2 ml, 2 doses 12 hrs apart on Days 2 to 5.
16174089|NCT01592214|Drug|XF-73 in 2% Klucel gel|XF-73 in a modified 2% Klucel® gel formulation: Part 1, #1: concentration 0.5 mg/g, twice a day in volume 0.3 mL/naris/dose, total dose 0.6 mg; Part 1, #2: 2.0 mg/g concentration, twice a day in volume 0.3 mL/naris/dose, total dose 2.4 mg; Part 2, #1: Concentration 0.5 mg/g, 3 doses 8 hours apart on Day 1, total volume 1.8 ml, total dose 0.9 mg, 2 doses 12 hours apart on Days 2-5, total volume 1.2 ml and total dose 0.6 mg ; Part 2, #2: 2.0 mg/g, 3 doses 8 hours apart on Day 1, total volume 1.8 ml, total dose 3.6 mg, 2 doses 12 hours apart on Days 2-5,total volume 1.2 ml and total dose 2.4 mg.
16174090|NCT01592214|Drug|XF-73 in 4% Klucel gel|XF-73 in a 4% Klucel® gel formulation: Part 2 #3: concentration of 0.5 mg/g and volume of 0.3 mL/naris/dose in 3 doses 8 hours apart on Day 1 and 2 doses, 12 hours apart on Days 2 to 5. Total daily volume of 1.8 ml on Day 1 and 1.2 ml on Days 2 to 5; and total daily dose of 0.9 mg on Day 1 and 0.6 mg on Days 2 to 5.
16174091|NCT01592201|Drug|Paliperdidone ER|Form = osmotic release oral system, route = oral
16174358|NCT01590407|Drug|ALS-002200|ALS-002200
16174092|NCT01592201|Drug|Aripiprazole, olanzapine and risperidone (Antipsychotics)|Form = tablet, route = oral
16174093|NCT01592188|Behavioral|Cognitively-Based Compassion Training (CBCT)|CBCT is a 12 week program that begins by teaching mindfulness and attention. It then goes on to use new mindfulness skills to consider topics of compassion, or unbiased acceptance and compassion for all other people, both friends, unfamiliar people, and enemies.
16174094|NCT01592188|Behavioral|Mindfulness training|Mindfulness training will consist of 6 weeks training in mindfulness meditation.
16174095|NCT01592162|Drug|Propofol (Astra-Zeneca), NaCl 0.9%|propofol administered by a closed-loop system and saline
16174096|NCT01592162|Drug|propofol 1% (Astra-Zeneca) and remifentanil|propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)
16174097|NCT01592162|Drug|propofol 1% (Astra-Zeneca) and remifentanil|propofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion)
16174098|NCT01592162|Drug|Propofol (Astra-Zeneca), NaCl 0.9%|propofol administered by a closed-loop system and saline
16174099|NCT01592162|Drug|Propofol (Astra-Zeneca) and remifentanil|propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)
16174100|NCT01592162|Drug|Propofol (Astra-Zeneca) and remifentanil|propofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion)
16174101|NCT01592162|Drug|Propofol (B-Braun) and NaCl 0.9%|propofol administered by a closed-loop system and saline
16174102|NCT01592162|Drug|Propofol (B-Braun) and remifentanil|propofol administered by a closed-loop system and remifentanil (2 ng/ml, target controled infusion)
16174103|NCT01592162|Drug|Propofol (B-Braun) and remifentanil|propofol administered by a closed-loop system and remifentanil (4 ng/ml, target controled infusion)
16174104|NCT01592149|Other|No Drug|No intervention will be given to subjects, survey of loss of appetite in patients suffering from various healthcare disorders.
16174105|NCT01592136|Drug|ponatinib|Patients will receive ponatinib 45 mg orally as a single dose once daily with or without food. Each patient will receive daily ponatinib until disease progression, unacceptable toxicity, or withdrawal of consent
16174106|NCT01592123|Procedure|The active anterior rhinomanometry|In this method, the airflow through 1 nasal cavity and the pressure gradient across this nasal cavity are measured simultaneously at each breath as recommended by the committee report on the standardization of rhinomanometry. All measurements were performed under the same standard conditions. Herein, all presented airflow values are the sum of inspiratory airflow of the right and left sides of the nose at 150 pascals (Pa). And, total nasal airflow (cm3/s) and airway resistance (Pa/cm3/s) values were used for statistical analyses.
16174107|NCT01592123|Behavioral|The Pittsburgh Sleep Quality Index (PSQI)|PSQI was developed to measure sleep quality during the previous month and to discriminate between good and poor sleepers. The self-administered scale contains 15 multiple-choice items that inquire about frequency of sleep disturbances and subjective sleep quality and 4 write-in items that inquire about typical bedtime, wake-up time, sleep latency, and sleep duration. Each component score ranges from 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range of 0-21). A PSQI global score >5 is considered to be suggestive of significant sleep disturbance.
16174108|NCT01592123|Behavioral|The Beck Anxiety Inventory (BAI)|The BAI is a 21-item self-report questionnaire that lists symptoms of anxiety. The respondent is asked to rate how much each symptom has bothered him/her in the past week. The symptoms are rated on a four-point scale, ranging from ''not at all'' (0) to ''severely'' (3). The instrument has excellent internal consistency and high test-retest reliability. The BAI has been widely used to measure severity of anxiety by self-report.
16174109|NCT01592123|Behavioral|The Van Dream Anxiety Scale (VDAS)|The VDAS provides the assessment of nightmare frequency and dream anxiety caused by frightening dreams during the preceding month. There are 17 self-rated questions in the scale. Twelve questions (1-4, 6, 11-17) that are tabulated in the scoring are weighted equally on a 0-4 scale. Question 5 is related to autonomic hyperactivity and consists of 12 symptoms. Each of 12 symptoms is also weighted on a 0-4 scale. Thirteen question scores are summed to yield a global VDAS score, which has a range of 0-42.
16174110|NCT01592110|Drug|risperidone-SABER|25 mg of risperidone-SABER administered as a subcutaneous (SC) injection of 0.25 mL
16174111|NCT01592110|Other|ZX003:risperidone-SABER and the DosePro System|50 mg risperidone-SABER administered as 0.5 mL via the DosePro Needle-Free Injection System
16174112|NCT01592110|Drug|risperidone-SABER|50 mg of risperidone-SABER administered as a SC injection of 0.5 mL
16174113|NCT01592110|Drug|Risperidone-SABER|100 mg of risperidone-SABER administered as a SC injection of 1.0 mL
16174114|NCT01592071|Other|Replace reactive foods with non-reactive foods|Subjects were provided with the test results and an individualized dietary plan based on replacing reactive foods with non-reactive foods as replacements per the Immuno Bloodprint results.
16174115|NCT01592045|Biological|ch14.18 -NCI|25 mg/m^2/day IV for four consecutive days
16174116|NCT01592045|Biological|ch14.18-UTC|17.5 mg/m^2/day IV for four consecutive days
16174117|NCT01592045|Biological|Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)|GM-CSF will be administered SC at a dose of 250 mcg/m^2/day for 14 days during Courses 1, 3, and 5.
16174118|NCT01592045|Biological|Aldesleukin (IL-2)|Aldesleukin (IL-2) will be administered IV at a dose of 3 MIU/m^2/day for the first week and at a dose of 4.5 MIU/m^2/day for the second week during Courses 2 and 4.
16174119|NCT01592045|Drug|Isotretinoin|"Isotretinoin (13-cis-retinoic acid; ISOT) will be administered by mouth over six courses as follows:
~If weight > 12 kg: 80 mg/m^2/dose twice daily (total daily dose is 160 mg/m^2/day, divided twice daily).
~If weight ≤ 12 kg: 2.67 mg/kg/dose twice daily (total daily dose is 5.33 mg/kg/day, divided twice daily)."
16174120|NCT01592032|Drug|Vancomycin antimicrobial-lock solution|Randomization of 5 patients into vancomycin antimicrobial-lock solution arm for 1, 3, 5, 7 and 10 days according to HPLC corrected by urea gradient. The arm can be stopped any time from day 1 to day 10 in case of antimicrobial concentration less than 1 mg/mL.
16174121|NCT01592032|Drug|Teicoplanin antimicrobial-lock solution|Randomization of 5 patients into teicoplanin antimicrobial-lock solution arm for 1, 3, 5, 7 and 10 days according to HPLC corrected by urea gradient. The arm can be stopped any time from day 1 to day 10 in case of antimicrobial concentration less than 1 mg/mL.
16174359|NCT01590407|Drug|Placebo|Placebo
16174122|NCT01592032|Drug|Linezolid antimicrobial-lock solution|Randomization of 5 patients into linezolid antimicrobial-lock solution arm for 1, 3, 5, 7 and 10 days according to HPLC corrected by urea gradient. The arm can be stopped any time from day 1 to day 10 in case of antimicrobial concentration less than 1 mg/mL.
16174123|NCT01592032|Drug|Daptomycin antimicrobial-lock solution|Randomization of 5 patients into daptomycin antimicrobial-lock solution arm for 1, 3, 5, 7 and 10 days according to HPLC corrected by urea gradient. The arm can be stopped any time from day 1 to day 10 in case of antimicrobial concentration less than 1 mg/mL.
16174124|NCT01592032|Drug|Tigecycline antimicrobial-lock solution|Randomization of 5 patients into tigecycline antimicrobial-lock solution arm for 1, 3, 5, 7 and 10 days according to HPLC corrected by urea gradient. The arm can be stopped any time from day 1 to day 10 in case of antimicrobial concentration less than 1 mg/mL.
16174125|NCT01592019|Drug|Reference, Patch location thigh, batch 1|Reference, Patch location thigh, batch 1
16174126|NCT01592019|Device|Test, Patch location thigh, batch 2|Test, Patch location thigh, batch 2. Three probes will be inserted at each visit.
16174127|NCT01592019|Drug|Reference, Patch location abdomen, batch 1|Reference, Patch location abdomen, batch 1
16174128|NCT01592019|Device|Test, Patch location abdomen, batch 2|Test, Patch location abdomen, batch 2. Three probes will be inserted at each visit.
16174129|NCT01592006|Drug|Peginterferon alfa-2a|Patients will be treated with pegylated interferon alfa-2a (Pegasys®) 180 mcg SQ per week for 12 weeks, followed by pegylated interferon alfa-2a (Pegasys®) and ribavirin for another 36 weeks. Patients will be assessed at periodic intervals for safety and adverse effects. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
16174130|NCT01592006|Drug|Ribavirin|Patients will be given ribavirin 600-1200 mg PO per day for 12 weeks, followed by pegylated interferon alfa-2a (Pegasys®) and ribavirin for another 36 weeks. Patients will be assessed at periodic intervals for safety and adverse effects. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
16174131|NCT01592006|Drug|telaprevir|Patients will be given telaprevir 750 mg tid (Incivek®) for 12 weeks, followed by pegylated interferon alfa-2a (Pegasys®) and ribavirin for another 36 weeks. Patients will be assessed at periodic intervals for safety and adverse effects. Following completion of therapy, patients will be followed for another 24 weeks to determine sustained response.
16174132|NCT01591993|Procedure|10% lactic acid test|To each subject, 10% lactic acid is applied to one nasolabial fold. This will be performed under humidity, temperature and pH control to avoid influence of these variables in the result of the test.
16174133|NCT01591993|Procedure|Placebo|To each subject, 0.9% saline solution will be applied to the contralateral nasolabial fold. This will be performed under humidity, temperature and pH control to avoid influence of these variables in the result of the test.
16174134|NCT01591980|Drug|Pregabalin|Pre-operatively, one of the 2 doses of pregabalin (100 or 150 mg) or placebo will be given to patients 1 hour before the surgery. Post-operatively, patients will receive daily (split in 2 equal doses) pregabalin 100 mg, pregabalin 150 mg, or placebo for the first 14 post-operative days.
16174135|NCT01591980|Drug|pregabalin|Pre-operatively, one of the 2 doses of pregabalin (100 or 150 mg) or placebo will be given to patients 1 hour before the surgery. Post-operatively, patients will receive daily (split in 2 equal doses) pregabalin 100 mg, pregabalin 150 mg, or placebo for the first 14 post-operative days.
16174136|NCT01591980|Drug|placebo|Identical placebo capsules will be administered in the same way.
16174137|NCT01591967|Device|Activator IV Adjusting Instrument|Activator (http://www.activator.com/products-page/) adjustment effects on BP and PR
16174138|NCT01591954|Device|Video Augmentation|Assessment of value of video-based navigation system
16174139|NCT01591941|Other|Core-PAC|"Core position and control movement strategy (Core-PAC):
~Do warm-up prior to 6 weeks of regular soccer training for peak flexion angles and peak abduction moments at the knee during a side-cut (SC) and an unanticipated side-cut (USC) prior to kicking a soccer ball and a side-hop (SH) task."
16174140|NCT01591915|Other|MBSR|Participants in Intervention 1 and Intervention 2 will participate in an 8 week course of MBSR practice of homework assignments consisting of 20 min sessions, 6 days/week. Participants will be provided information material including a book of 20 pages introduction to mindfulness training, self-instructing CD, diary and training program. Only participants in Intervention 1 will partake in a structured group-formatted 8 week course that patients attend once a week for an average of 2 h. Led by a certified MBSR instructor, these weekly group sessions are focused on participant's experiences of mindfulness, and include yoga and meditation training. Four registered nurses, skilled in patient learning, have been educated as certified MBSR instructors.
16174141|NCT01591902|Drug|Tesamorelin|Daily 2 mg subcutaneous injections of tesamorelin
16174142|NCT01591902|Drug|Placebo-Control|3.0 mL vials
16174143|NCT01591889|Drug|Tinidazole|500 mg tablet
16174144|NCT01591889|Drug|Tinidazole|500 mg tablet
16174145|NCT01591876|Other|Intradialytic aerobic exercise|Participants in the intervention group will undertake moderate intensity aerobic exercise. Exercise modality will be recumbent cycling during the first two hours of haemodialysis sessions. Exercise prescription is set using a graded exercise test and anchored to a perceived level of exertion using the BORG scale. Training stimulus is maintained by the participant by increasing the cycling resistance when perceived exertion drops by one point at the current resistance level. Adherence and training volume is recorded during the intervention period.
16174146|NCT01591876|Other|Progressive Muscle relaxation|This is a sequence of stretching and relaxation of the major muscle groups of the body. Participants are initially given detailed information regarding the technique and then provided with a recorded version which they listen to for 30-40 minutes during dialysis sessions. Participants in this group are offered the exercise programme at the end of three months.
16174147|NCT01591863|Drug|fidaxomicin|"6 months-5 years 11 months: oral suspension, 32 mg/kg/day with a maximum dose of 400 mg/day, divided into two doses, every 12 hours for 10 days.
~6 years-17 years 11 months: tablets, 200 mg every 12 hours for 10 days."
16174148|NCT01591850|Drug|RO5093151|Single oral dose
16174149|NCT01591850|Drug|atazanavir|Multiple oral doses
16174150|NCT01591850|Drug|ketoconazole|Multiple oral doses
16174151|NCT01591850|Drug|rifampicin|Multiple oral doses
16174152|NCT01591850|Drug|ritonavir|Multiple oral doses
16174153|NCT01591837|Biological|CSL Influenza Vaccine|The study vaccine (CSL Influenza Vaccine) is a sterile, thiomersal-free suspension containing 45 mcg total haemagglutinin antigen per 0.5 mL dose (15 mcg each of the three recommended influenza strains for the Northern Hemisphere 2012/2013 influenza season). The vaccine will be administered by intramuscular or subcutaneous injection.
16174154|NCT01591824|Other|Resonant oscillation|"Resonant sustained oscillations are applied in the following areas
~general column.
~lumbar muscles, and paraspinal muscles,
~sacral decompression oscillatory
~Opening by lateral vertebral lumbar rhythmic swing.
~Balancing and pelvic decompression
~Swing-lumbar vertebral rotation."
16174155|NCT01591824|Other|column exercise group|"paraspinal muscle stretching exercises
~postural correction
~mobilization exercises thoracic and lumbar
~Motor control exercises"
16174156|NCT01591811|Radiation|Arm 1 Daily Boost of Radiation Therapy|Arm 1 Daily boost. IMRT at 2.7Gy x15 fractions. Total dose 40.50Gy. Daily Boost 0.5Gy to tumor bed x 15 fractions. Tumor Bed Total=48Gy
16174157|NCT01591811|Radiation|Arm 2 Weekly Boost of Radiation Therapy|Arm2: IMRT at 2.7Gy x 15 fractions. Total Dose=40.50 Gy. Weekly Boost 2Gy (on Friday). Tumor Bed Total 46.50Gy
16174158|NCT01591798|Procedure|Robotic surgery|Robotic assisted rectal resection
16174159|NCT01591798|Procedure|Laparoscopic surgery|Laparoscopic assisted rectal resection
16174160|NCT01591785|Drug|Retapamulin 1% ointment|Retapamulin 1% ointment for 5 days AND clobetasol propionate foam for 14 days
16174161|NCT01591785|Drug|Placebo|Placebo ointment for 5 days AND clobetasol propionate foam for 14 days
16174162|NCT01591772|Other|Neuroimaging & Neuropsychological Evaluation|Will undergo structural and functional MRI scans on a Siemens 3T Magnetom Tim Trio research scanner located at the Citigroup Biomedical Imaging Center at Weill Cornell Medical Center (WCMC), which is adjacent to the MSKCC campus. Patients do not undergo routine clinical brain MRIs as part of their assessment and treatment, and the brain MRI scans to be performed in this study are for research purposes only. The MRI scan takes approximately 60 minutes to complete, and about 15 minutes will be required for instructions prior to initiating the study. The MRI studies will be reviewed by a neuroradiologist (Dr. Karimi) to rule out gross structural CNS abnormalities; in case any abnormalities considered to require clinical follow-up are detected, the subject will be contacted and referred for follow-up with their treating physician. Patients will undergo a brief neuropsychological test battery at MSKCC or at Citigroup Biomedical Imaging Center at WCMC
16174163|NCT01591772|Other|Neuroimaging & Neuropsychological Evaluation|Will undergo structural and functional MRI scans on a Siemens 3T Magnetom Tim Trio research scanner located at the Citigroup Biomedical Imaging Center at Weill Cornell Medical Center (WCMC), which is adjacent to the MSKCC campus. Patients do not undergo routine clinical brain MRIs as part of their assessment and treatment, and the brain MRI scans to be performed in this study are for research purposes only. The MRI scan takes approximately 60 minutes to complete, and about 15 minutes will be required for instructions prior to initiating the study. The MRI studies will be reviewed by a neuroradiologist (Dr. Karimi) to rule out gross structural CNS abnormalities; in case any abnormalities considered to require clinical follow-up are detected, the subject will be contacted and referred for follow-up with their treating physician. Patients will undergo a brief neuropsychological test battery at MSKCC or at Citigroup Biomedical Imaging Center at WCMC
16174164|NCT01591759|Drug|Citicoline|2,000mg/day of citicoline taken as twice daily unit doses of 1,000 mg for the 8-week period of the clinical trial
16174165|NCT01591759|Drug|Placebo|Placebo arm of single-blind study
16174166|NCT01591746|Drug|Botulinum Toxin Type A|
16174167|NCT01591746|Drug|Placebo|5 mL 0.9% NaCl solution to mimic Botulinum Toxin Type A
16174168|NCT01591733|Drug|FOLFIRINOX|Up to Eight-14 day cycles
16174169|NCT01591733|Drug|Capecitabine|Orally, for 10 days
16174170|NCT01591733|Radiation|Short Course Radiation|Five or ten days
16174171|NCT01591733|Procedure|Surgery|1-4 weeks after completion of capecitabine therapy
16174172|NCT01591720|Behavioral|Tailored Internet-based CBT for depression and anxiety|"This Internet-based CBT intervention contains 8-10 text-based self-help modules in which 4 modules are fixed (the first three and the last) and the rest are prescribed following the diagnostic interview. These modules contain material on panic disorder, social phobia, stress management, assertiveness training, concentration, relaxation among other things."
16174173|NCT01591707|Behavioral|ISC+PRT Intervention|Teachers will be trained to implement an intervention in preschool ASD classrooms that provides a learning environment in which social and communication skills are focused on.
16174174|NCT01591681|Device|Pump suspension|The study laptop will communicate to the pump causing a suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.
16174175|NCT01591668|Drug|Single Ascending Dose Cohorts GS-9620|This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Dose cohorts may be dosed with one of up to 4 possible total weekly doses (0.3 mg, 1 mg, 2 mg, 4 mg). Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.
16174176|NCT01591668|Drug|Multiple Ascending Dose Cohorts GS-9620|This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses).
16174177|NCT01591655|Drug|Mapracorat|1 drop of study medication into the study eye four times daily (QID) for 14 days
16174178|NCT01591655|Drug|Vehicle|1 drop of vehicle into the study eye QID for 14 days.
16174179|NCT01591629|Drug|Naloxone|Active Naloxone 18 mcg/kg intravenously over 60 minutes, 2mg IV push, 1mg IV push
16174180|NCT01591629|Drug|Delta-9-THC|Active Delta-9-THC (0.025mg/Kg) given intravenously over 20 minutes.
16174181|NCT01591629|Drug|Placebo|Placebo
16174182|NCT01591616|Drug|lidocaine and prilocaine|Appropriate dose of Oraqix based on weight will be given before tooth extraction
16174183|NCT01591603|Procedure|1 cm|A Tuohy needle will be advanced in-plane with the bevel cephalad to a point that lies between the tibial and common peroneal branches of the sciatic nerve. The catheter will be advanced 1 cm past the tip of the Tuohy
16174184|NCT01591603|Procedure|5 cm|A Tuohy needle will be advanced in-plane with the bevel cephalad to a point that lies between the tibial and common peroneal branches of the sciatic nerve. The catheter will be advanced 5 cm past the tip of the Tuohy
16174188|NCT01591577|Other|Lapatinib/Temozolomide/radiation|Patients will be treated with a pulse dose of lapatinib every week and temozolomide 75 mg/m2 daily during radiation. Lapatinib will be administered beginning on the first day of radiation and temozolomide (+/-2 days). External beam fractionated regional radiation will be given on consecutive week days at 200 cGy daily doses to a total dose of 6000 cGy. Patients will have rest from temozolomide only for 2-4 weeks. Patients will continue with weekly pulse-dosing of lapatinib. After a 2-4 weeks rest(for temozolomide only) following completion of radiation therapy, temozolomide will be restarted as Cycle 1 at 150 mg/m2/day for 5 days out of every 28.Subsequent cycles can increase to 200 mg/m2/day as tolerated per investigator's judgment. Lapatinib pulse doses will be continued every week without interruption.Treatment will continue for 24 additional 28-day cycles of temozolomide if there is no evidence of progression.
16174189|NCT01591564|Behavioral|Interpersonal Psychotherapy for youth with SMD (IPT-SMD)|Youth will receive weekly therapy sessions for 16 weeks and then bi-weekly session until week 20. Parent sessions will also be included.
16174190|NCT01591551|Drug|Natalizumab (Tysabri)|300 mg IV every 4 weeks
16174191|NCT01591525|Behavioral|Education on risk factors for Type II Diabetes|one-on-one education provided by a nurse practitioner or physician
16174192|NCT01591525|Behavioral|Education on Type II Diabetes|one-on-one education about having Type II Diabetes, the possible complications and treatment options provided by a physician.
16174193|NCT01591525|Behavioral|Education on regular visits to a Primary Care Provider|one-on-one education about the importance of visiting a primary care provider (PCP) on a regular basis. Patients are also provided a list of PCP's accepting new patients within a 3 mile radius.
16174194|NCT01591499|Device|BIOFINITY® MF - AIR OPTIX® AQUA MF|During the first period, the participant will be allocated at random either the test lens pair (Biofinity) or a comparator lens pair (Air Optix or Purevision); during the second period, the participant will crossover to the alternate lens pair. (Biofinity crossover to Air Optix or Purevision) (Air Optix or Purevision crossover to Biofinity)
16174195|NCT01591499|Device|BIOFINITY® MF - PUREVISION® MF|During the first period, the participant will be allocated at random either the test lens pair (Biofinity) or a comparator lens pair (Air Optix or Purevision); during the second period, the participant will crossover to the alternate lens pair. (Biofinity crossover to Air Optix or Purevision) (Air Optix or Purevision crossover to Biofinity)
16174196|NCT01591473|Drug|Poly I:Poly C12U 50 ug|Poly I:Poly C12U 50 ug; 3 doses; nasal administration every 28 days
16174197|NCT01591473|Drug|Poly I:Poly C12U 200 ug|Poly I:Poly C12U 200 ug; 3 doses; nasal administration every 28 days
16174198|NCT01591473|Drug|Poly I:Poly C12U 500 ug|Poly I:Poly C12U 500 ug; 3 doses; nasal administration every 28 days
16174199|NCT01591473|Drug|Poly I:Poly C12U 1250 ug|Poly I:Poly C12U 1250 ug; 3 doses; nasal administration every 28 days
16174200|NCT01591473|Drug|Placebo|Placebo; 3 doses; nasal administration every 28 days
16174201|NCT01591473|Drug|FluMist|FluMist 0.2 ml; 3 doses; nasal administration every 28 days
16174202|NCT01591460|Drug|boceprevir|800 mg three times daily for 24, 32 or 44 weeks
16174203|NCT01591460|Drug|peginterferon alfa-2a [Pegasys]|180 mcg subcutaneously once a week for 24, 32 or 44 weeks
16174204|NCT01591460|Drug|peginterferon alfa-2a [Pegasys]|180 mcg subcutaneously once a week for 4 weeks
16174205|NCT01591460|Drug|ribavirin (Copegus]|1000 mg or 1200 mg orally once a day for 24, 32 or 44 weeks
16174206|NCT01591460|Drug|ribavirin (Copegus]|1000 mg or 1200 mg orally once a day for 4 weeks
16174207|NCT01591447|Drug|solithromycin|A single oral dose of 1200 mg solithromycin (CEM-101)
16174208|NCT01591447|Drug|Solithromycin (CEM-101)|A single oral dose of 1000 mg solithromycin
16174209|NCT01591434|Device|AQUACEL®|Dressing to be changed as clinically needed or at least every seven days.
16174210|NCT01591434|Device|AQUACEL® Extra™|Dressing to be changed as clinically needed or at least every seven days.
16174211|NCT01591421|Drug|BKM120|PO; Once daily starting day 1 cycle 1, or 5 out of 7 days every week.
16174212|NCT01591421|Drug|Panitumumab|IV; Every two weeks starting day 1 cycle 1 (i.e. day 1 and 15 each 28 day cycle)
16174213|NCT01591408|Device|EEG biofeedback|EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues.
16174214|NCT01591395|Procedure|laparoscopic total extraperitoneal hernia repair (single port vs. multiport)|comparison of single port laparoscopic TEP and multiport laparoscopic TEP repair for adult inguinal hernia
16174215|NCT01591382|Drug|Ketamine|Intravenous (IV) ketamine 0.2 mg/kg/hr for 24-48 hours postoperatively.
16174216|NCT01591382|Drug|Placebo|Patients who received ketamine-matching placebo were given saline infusions
16174217|NCT01591382|Drug|Hydromorphone PCA|Intravenous hydromorphone PCA
16174218|NCT01591356|Drug|EphA2-targeting DOPC-encapsulated siRNA|Given IV
16174219|NCT01591356|Other|Laboratory Biomarker Analysis|Correlative studies
16174220|NCT01591356|Other|Pharmacological Study|Correlative studies
16174221|NCT01591343|Biological|Depigoid® (500 DPP/ml)|"Depigoid® D. pteronyssinus or Depigoid® 50% D. pteronyssinus / 50% D. farinae (500 DPP/ml).
~Dose:
~Week 0: 0.2 ml followed by 0.3 ml after 30 min Week 4, 8, 12, and 16: 0.5 ml Mode of administration: subcutaneous injection"
16174222|NCT01591330|Drug|LY2140023 Reference form|80-mg tablet administered orally
16174223|NCT01591330|Drug|LY2140023 Test-Low|80-mg tablet administered orally
16174224|NCT01591330|Drug|LY2140023 Test-Medium|80-mg tablet administered orally
16174225|NCT01591330|Drug|LY2140023 Test-High|80-mg tablet administered orally
16174226|NCT01591317|Drug|Prasugrel|Tablets orally
16174227|NCT01591304|Device|Ulthera System Treatment|Focused ultrasound energy delivered below the surface of the skin.
16174228|NCT01591291|Drug|Ondansetron + Brief Behavioral Enhancement Treatment|Ondansetron 4ug/kg twice daily
16174229|NCT01591291|Drug|Placebo + Brief Behavioral Enhancement Treatment|Placebo twice daily
16174230|NCT01591278|Other|Pulpotomy|Comparison of two different pulp dressing agents
16174231|NCT01591278|Other|Pulpotomy|Comparison of two different pulp dressing agents
16174232|NCT01591265|Procedure|Extraction of upper and lower FPM teeth|Extraction of upper and lower FPM teeth
16174233|NCT01591265|Procedure|Extraction of lower FPM tooth|Extraction of lower FPM tooth only
16174234|NCT01591239|Behavioral|Home-Based Intervention|Parents will be trained through a 3 1/2-hour series on providing a 3-session drug and alcohol intervention program to their adolescent. The parent-led intervention will require parents to meet with their adolescent and work together to help strengthen family cohesiveness, enhance communication, and promote healthy life choices.
16174235|NCT01591239|Behavioral|Educational Group|Printed fact sheets will be delivered to parents in a single two-hour session. These fact sheets will provide general drug-related information from the public domain (e.g., substance use trends and well-known dangers of substance involvement), and focus on communication approaches and talking points when discussing substance use with their adolescent (e.g., why adolescents use; how the media may influence attitudes about substances).
16174236|NCT01591226|Dietary Supplement|Caffeine|gelatine capsule 6mg/kg bodyweight 60min prior test
16174237|NCT01591226|Dietary Supplement|Sodium Citrate|0.5g/kg bodyweight diluted in 7dl water ingested 120-90min prior test
16174238|NCT01591226|Dietary Supplement|Mannitol|gelatine capsule filled with mannitol (100mg per capsule) ingested 60min prior test
16174239|NCT01591226|Dietary Supplement|Sodium Chloride|sodium chloride diluted in 7dl water 0.045g/kg bodyweight 120-90min prior test
16174240|NCT01591200|Biological|Allogeneic Mesenchymal Stem Cells|High dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery
16174241|NCT01591200|Biological|Allogeneic Mesenchymal Stem Cells|Intermediate dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery
16174242|NCT01591200|Biological|Allogeneic Mesenchymal Stem Cells|Low dose of Bone Marrow Derived Allogeneic Mesenchymal Stem Cells will be administered through the hepatic artery
16174243|NCT01591187|Other|Text messaging|Participants report on the smoking that takes place in their presence for a period of 7 days by responding to daily texted messages sent by the research team to their mobile phones. Parents will also be asked to report on the child's SHSe during the same 7-day period so that child and parent reports can be compared.
16174244|NCT01591187|Other|Questionnaire|Child and parent questionnaire data about attitudes, behavioral practices to control SHSe, and other socio-environmental factors will be obtained.
16174245|NCT01591187|Other|Interviews|Individual interviews with youngsters will provide additional qualitative information about the social context and conditions in the child's environment that maintain or contribute to avoidance of exposure.
16174246|NCT01591161|Drug|Mapracorat|1 drop of study medication into the study eye QID for 14 days
16174247|NCT01591161|Drug|Placebo|1 drop of vehicle into the study eye QID for 14 days.
16174248|NCT01591148|Drug|propofol|Morbidly obese subjects (body mass index greater than 40)and control subjects (body mass index 20-25) will be given propofol for induction of general anesthesia. Plasma samples will be taken to ascertain drug concentration over time.
16174249|NCT01591135|Drug|Paclitaxel plus 5-fluorouracil|5-ﬂuorouracil 300 mg/m2, d1-4, continuous infusion for 96 hours and paclitaxel 50 mg/m2 over 3 hours, d1 (week 1, week 2, week 3, week 4 and week 5); 5-ﬂuorouracil 600 mg/m2/d d1-3 and paclitaxel 175 mg/m2 d1(week 9 and week 13).
16174250|NCT01591135|Drug|Cisplatin plus 5-fluorouracil|cisplatin 25 mg/m2/d, d1-3, once every 4 weeks for 4 cycles (week 1, week 5, week 9 and week 13); 5-FU 600 mg/m2/d, d1-3, continuously infusion for 72 hrs,once every 4 weeks for 4 cycles (week 1, week 5, week 9 and week 13).
16174251|NCT01591135|Radiation|Radiation therapy|A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks.
16174252|NCT01591135|Radiation|Radiation therapy|A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks.
16174253|NCT01591122|Drug|Placebo and prednisone|Placebo: Form=tablet, route=oral. Four tablets daily on an empty stomach. Prednisone: Type=exact number, unit=mg, number=5, form=tablet, route=oral, twice daily.
16174254|NCT01591122|Drug|Abiraterone acetate and prednisone|Abiraterone acetate: Type=exact number, unit=mg, number=250, form=tablet, route=oral. Four tablets daily on an empty stomach Prednisone: Type=exact number, unit=mg, number=5, form=tablet, route=oral, twice daily
16174255|NCT01591096|Drug|Tissue plasminogen activator (Activase®)|Investigation labeled tPA will be obtained for all sites by the Core Pharmacy as commercially available recombinant tPA (Genentech as Activase®) for IV administration. The Bayesian method of toxicity probability intervals will be used to select one of the following three dose tiers (0.75, 0.9, 1.0 mg/kg) of IV tPA. The dose escalation for the two age groups (2-10, 11-17 years) will be performed independently. The maximum dose for each tier will be reached at a weight of 90 kg.
16174256|NCT01591083|Drug|esomeprazole (Nexium®, AstraZeneca AB, Södertälje, Sweden)|"Each enrolled patient receives an 80 mg loading dose of intravenous esomeprazole (Nexium®, AstraZeneca AB, Södertälje, Sweden) immediately after hemostasis was achieved spontaneously or by gastroscopy. Patients then received a 3-day continuous high dose (8 mg per hour) of esomeprazole infusion. Then, patients with Rockall score >=6 are randomized into the double oral dose group and the regular oral dose group. Patients with Rockall score <6 are assigned to the control group.
~In the double oral dose group, patients receive 40 mg oral esomeprazole twice daily for 11 days and followed by 40 mg once daily for 14 days. In the other two groups, patients receive 40 mg oral esomeprazole 40 mg once daily for 25 days."
16174257|NCT01591070|Drug|Tacrolimus|0.1% tacrolimus once-weekly application for 10 weeks
16174258|NCT01591070|Drug|Tacrolimus|0.1% tacrolimus twice weekly application for 10 weeks
16174259|NCT01591057|Dietary Supplement|2 portions of fruit and vegetables per day|Consume 2 portions of fruit and vegetables per day
16174260|NCT01591057|Dietary Supplement|5 portions of fruit and vegetables per day|Consume 5 portions of fruit and vegetables per day
16174261|NCT01591057|Dietary Supplement|8 portions of fruit and vegetables per day|Consume 8 portions of fruit and vegetables per day
16174262|NCT01591044|Drug|Placebo|1 puff bid or 2 puffs bid
16174263|NCT01591044|Drug|R940343 1mg|R343 1mg, 1 puff bid
16174264|NCT01591044|Drug|R940343 2mg|R343 2mg, 2 puffs bid
16174265|NCT01591031|Drug|Sevoflurane|anesthesia induction with propofol, remifentanil and sevoflurane; afterwards tracheal intubation
16174266|NCT01591031|Drug|Rocuronium|anesthesia induction with propofol, remifentanil and rocuronium; afterwards tracheal intubation
16174267|NCT01591018|Procedure|sonolysis|continual transcranial Doppler monitoring with max. diagnostic intensity for min. 60 minutes
16174268|NCT01591018|Procedure|cardiac surgery|coronary artery bypass graft (CABG) heart valve replacement
16174269|NCT01591005|Procedure|sonolysis|continual transcranial Doppler monitoring with max. diagnostic intensity for 60 minutes
16174270|NCT01591005|Procedure|endarterectomy|carotid endarterectomy
16174271|NCT01591005|Procedure|carotid stenting|percutaneous transluminal angioplasty and stenting
16174272|NCT01590992|Behavioral|Exposure-based psychotherapy for somatic symptoms|Application of different types of exposure-based psychotherapeutic interventions (behavioral therapy), adapted for subjects with somatic symptoms (Somatoform Disorders/Functional Somatic Syndromes)
16174273|NCT01590992|Behavioral|Relaxation therapy|Progressive muscle relaxation (Jacobson)
16174274|NCT01590979|Drug|Ranolazine|1000mg, two times a day, 12 hour intervals
16174275|NCT01590979|Drug|Placebo|two times a day, 12 hour intervals
16174276|NCT01590966|Drug|administration of Cimzia®|Patients will be treated with prefilled syringes containing each 200 mg/ml Cimzia® every 2 weeks which will be administered subcutaneously (The first 3 injections, a dosage of 400mg Cimzia® subcutaneously will be administered).
16174277|NCT01590966|Drug|Immunoscintigraphy with radiolabeled Cimzia®.|All 20 patients will undergo an immunoscintigraphy with radiolabeled Cimzia®. Certolizumab pegol (Cimzia®) is an engineered humanized monoclonal antibody Fab' fragment with specificity for human TNF-α, manufactured in E. coli. The antibody fragment is subsequently purified and conjugated with high molecular weight polyethylene glycol (PEG) (40kDa). Lyophilized Cimzia® will be conjugated with S-HYNIC (a bifunctional chelator). The conjugate will be radiolabeled with Tc-99m by adding 0.1 mg Tricine, 0.01 mg SnSO4 and 750 MBq Tc-99m pertechnetate. A dose of 750 MBq Tc-99m Cimzia® will be injected intravenously.
16174278|NCT01590940|Procedure|Open inguinal hernia repair with mesh|
16174279|NCT01590914|Procedure|Fed Condition|Subjects will consume a 250ml liquid test meal (250kcal) before undergoing a 40min fMRI scan to assess the BOLD signal responses to visual and auditory responses to food and non-food cues.
16174280|NCT01590914|Procedure|Fasted Condition|Subjects will consume a 250ml control (water) before undergoing a 40min fMRI scan to assess BOLD signal response to visual and auditory food and non-food cues
16174281|NCT01590901|Drug|Probucol|250mg (1 tablet) bid. p.o for 14 consecutive days
16174282|NCT01590888|Drug|PBT2|250mg capsules administered orally once per day for 26 weeks
16174283|NCT01590888|Drug|PBT2|100mg capsules administered orally once per day for 26 weeks
16174284|NCT01590888|Drug|Placebo|Matching capsules administered orally once per day for 26 weeks
16174285|NCT01590875|Drug|Adenosine arm|In the adenosine arm, 25 patients will be randomized to received 2 doses of adenosine 12 mg IV, 5 minutes apart after pulmonary vein isolation. During this time, will monitor for pulmonary vein reconnection, second dose of adenosine will be given only if no reconnection after initial dose. In the observation arm, 25 patients will be randomized to 10 minute period of observation for pulmonary vein reconnection after documentation of pulmonary vein isolation.
16174286|NCT01590862|Device|Deep Brain Stimulator|Medtronic Deep Brain Stimulation device turned on and off
16174287|NCT01590849|Drug|Contraceptives, Oral, Combined (Yaz®)|"After a counseling session concerning the advantages, disadvantages and side effects of contraceptive methods (COC or nonhormonal methods), the volunteers were divided into two study groups according to the method they chose to use as follows:
~Case group: healthy women, users of COC containing 20 mcg ethynil estradiol and 3 mg drospirenone , 24 days of active pills, 4 days of pill-free interval (n=40).
~Control group: healthy women, users of nonhormonal methods of contraception (condoms or copper IUD) (n=40).
~Subjects were tested once before the introduction of the contraceptive method and again after 6 months of its use."
16174288|NCT01590836|Drug|insulin degludec|Administered subcutaneously (s.c., under the skin) once daily (plus insulin aspart as bolus insulin as required).
16174289|NCT01590836|Drug|insulin degludec/insulin aspart|Single dose administered subcutaneously (s.c., under the skin).
16174290|NCT01590823|Drug|Dabigatran Etexilate 110 mg|All participants will receive a single dosage of dabigatran etexilate 110 mg at the start of their 4 hour dialysis session. Blood sampling will be conducted during and up to 48 hours after participant's dialysis session.
16174291|NCT01590810|Drug|MK-8150 2.0 mg|Single oral 2.0-mg dose of MK-8150
16174292|NCT01590810|Drug|MK-8150 10 mg|Single oral 10-mg dose of MK-8150
16174293|NCT01590810|Drug|MK-8150 40 mg|Single oral 40-mg dose of MK-8150 without food (fasted) and with food (fed)
16174294|NCT01590810|Drug|MK-8150 90 mg|Single oral 90-mg dose of MK-8150
16174295|NCT01590810|Drug|MK-8150 5.0 mg|Single oral 5.0-mg dose of MK-8150
16174296|NCT01590810|Drug|MK-8150 20 mg|Single oral 20-mg dose of MK-8150
16174297|NCT01590810|Drug|MK-8150 60 mg|Single oral 60-mg dose of MK-8150
16174298|NCT01590810|Drug|MK-8150 120 mg|Single oral 120-mg dose of MK-8150
16174299|NCT01590810|Drug|MK-8150 160 mg|Single oral 160-mg dose of MK-8150
16174300|NCT01590810|Drug|MK-8150 320 mg|Single oral 320-mg dose of MK-8150
16174301|NCT01590810|Drug|MK-8150 600 mg|Single oral 600-mg dose of MK-8150
16174302|NCT01590810|Drug|MK-8150 900 mg|Single oral 900-mg dose of MK-8150
16174303|NCT01590810|Drug|MK-8150 1200 mg|Single oral 1200-mg dose of MK-8150
16174304|NCT01590810|Drug|Placebo for MK-8150|Single oral dose-matched dose of Placebo for MK-8150
16174305|NCT01590810|Drug|MK-8150 50 mg|Single oral 50-mg dose of MK-8150
16174306|NCT01590810|Drug|MK-8150 100 mg|Single oral 100-mg dose of MK-8150
16174307|NCT01590810|Drug|MK-8150 200 mg|Single oral 200-mg dose of MK-8150
16174308|NCT01590810|Drug|MK-8150 400 mg|Single oral 400-mg dose of MK-8150
16174309|NCT01590810|Drug|MK-8150 500 mg|Single oral 500-mg dose of MK-8150
16174310|NCT01590797|Drug|Sitagliptin|Sitagliptin 100 mg once daily for 24 weeks
16174311|NCT01590797|Drug|Placebo|Matching placebo once daily for 24 weeks
16174312|NCT01590797|Biological|Insulin|Participants can be on on pre-mixed (mixture of rapid- and long-acting insulin) or intermediate- or long-acting insulin at a dose of at least 12 U/day.
16174313|NCT01590797|Drug|Metformin|At randomization, participants will be stratified according to their use of metformin (on or not on). All participants receiving metformin will be required to be on a daily dose of metformin at least 1500 mg per day.
16174314|NCT01590771|Drug|Sitagliptin|Sitagliptin 100 mg oral tablet once daily for 24 weeks
16174315|NCT01590771|Drug|Placebo|Matching placebo to sitagliptin oral tablet once daily for 24 weeks
16177560|NCT01565772|Drug|Etoposide|50 mg/m2 IV on days 1-5 on Cycles 1-2
16174316|NCT01590771|Drug|Gliclazide|Participants will continue ongoing open-label therapy with gliclazide (dosed according to the China drug label) throughout the study.
16174317|NCT01590771|Drug|Glimepiride|Participants will continue ongoing open-label therapy with glimepiride (dosed according to the China drug label) throughout the study.
16174318|NCT01590771|Drug|Metformin|Participants will continue ongoing open-label therapy with metformin (at least 1500 mg daily) throughout the study.
16174319|NCT01590758|Drug|Topical pexiganan cream 0.8%|14 days of treatment
16174320|NCT01590758|Drug|Topical placebo cream|14 days of treatment
16174321|NCT01590758|Other|Standard wound care|14 days of treatment
16174322|NCT01590745|Device|EMS Therasonic 460 Primo Ultrasound therapy|1MHz / 1.0W/cm square probe for 15 minutes per session for 20 sessions.
16174323|NCT01590732|Drug|Carboplatin|Given IV
16174324|NCT01590732|Drug|Etoposide|Given IV
16174325|NCT01590732|Drug|Ifosfamide|Given IV
16174326|NCT01590732|Drug|Romidepsin|Given IV
16174327|NCT01590719|Drug|Placebo|Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
16174328|NCT01590719|Drug|Onartuzumab (MetMAb)|Repeating intravenous dose until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
16174329|NCT01590719|Drug|Oxaliplatin|Oxaliplatin 85 mg/m2 IV every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
16174330|NCT01590719|Drug|Folinic acid|Folinic acid 400 mg/m2 every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
16174331|NCT01590719|Drug|Levofolinic acid|If folinic acid is unavailable: levofolinic acid 200 mg/m2 every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
16174332|NCT01590719|Drug|5-Fluorouracil|5-Fluorouracil 400 mg/m2 IV followed by 2400 mg/m2 IV infusion every 2 weeks until disease progression, unacceptable toxicity, or patient or physician decision to discontinue treatment
16174333|NCT01590693|Drug|Botulinum toxin A|The children in Group 2 underwent bilateral treatment with a total of 12 units/kg bodyweight Botox® (Allergan, California, USA). Four injection sites in each calf - two in the proximal third of the lateral and medial gastrocnemius bellies and two distally in the gastrocnemius-soleus complex - were administered. All injections were performed with electromyogram amplifier guidance to ensure intramuscular position. Children in both groups were treated with four weeks of below knee walking casts. Children in group 2 received the casts 1-2 weeks after botulinum toxin A treatment.
16174334|NCT01590680|Radiation|I-131 MIBG|The therapeutic dose (5-18 mCi/kg at investigator's discretion; any dose ≥12 mCi/kg requires stored stem cells) will be diluted in normal saline, and will be infused intravenously over 90-120 minutes.
16174335|NCT01590667|Device|Litramine|2 tablets 3 times daily (oral consumption, 30 minutes after meal)
16174336|NCT01590667|Device|Placebo|2 tablets 3 times daily (oral consumption, 30 minutes after meal)
16174337|NCT01590654|Drug|Single Ascending Dose (SAD) Cohorts GS-9620|This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.
16174338|NCT01590654|Drug|Multiple Ascending Dose (MAD) Cohorts GS-9620|This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses).
16174339|NCT01590641|Drug|Single Ascending Dose (SAD) Cohorts GS-9620|This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Single Ascending Dose (SAD) Cohorts will receive a single dose of GS-9620.
16174340|NCT01590641|Drug|Multiple Ascending Dose (MAD) Cohorts|This study will enroll cohorts of 6 eligible, unique subjects per cohort, randomized to either active drug or placebo (5:1) within each cohort. Subjects in Multiple Ascending Dose (MAD) Cohorts will receive GS-9620 once weekly for two weeks (QW x 2 doses)
16174341|NCT01590628|Drug|NiCord|NiCord® is a cell-based product composed of umbilical cord-derived ex vivo expanded stem and progenitor cells
16174342|NCT01590615|Drug|Anti-HBV nucleoside/nucleotide therapy|Subjects with chronic HBV infection and with decompensated liver disease who are receiving or anticipated to receive anti-HBV nucleoside/nucleotide therapy will be identified at centers with liver disease expertise where subjects are monitored on a regular basis.
16174343|NCT01590563|Device|IUD|Insertion of a spherical IUD, one year follow-up
16174344|NCT01590550|Procedure|Use of citrate based dialysate|Use of heparin free citrate based dialysate
16174345|NCT01590537|Drug|Levonorgestrel (Mirena, BAY86-5028)|intrauterine system containing 52 mg levonorgestrel, with daily release of 20 mcg levonorgestrel
16174346|NCT01590537|Device|Copper IUD|Copper device, inserted intrauterine
16174347|NCT01590524|Behavioral|Guided Imagery and Progressive Muscle Relaxation|Daily implementation of the guided imagery and progressive muscle relaxation techniques additionally to weekly supervised sessions.
16174348|NCT01590485|Other|starch|100 mg in each capsule every 6 hours up to 48 hours (400 mg/day)
16174349|NCT01590485|Other|saffron|100 mg in each capsule every 6 hours up to 48 hours (400 mg/day)
16174350|NCT01590459|Drug|VX-509|50 mg oral tablet
16174351|NCT01590459|Drug|VX-509 matching placebo|0 mg oral tablet
16174352|NCT01590446|Drug|BMN 111|SC injection, Part 1 single dose and Part 2 multiple dose.
16174353|NCT01590446|Drug|Normal Saline|SC injection, Part 1 single dose and Part 2 multiple dose
16174354|NCT01590433|Drug|Exenatide|Subjects will inject 5mcg of exenatide subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study.
16174355|NCT01590433|Drug|Placebo|Subjects will inject 5mcg of identically dispensed placebo subcutaneously 15 minutes before the morning and evening meal for the first 2 weeks of the study. At study week 2, subjects will increase to 10mcg twice daily for the remainder of the study.
16174356|NCT01590433|Behavioral|Dietary counseling|All subjects will also receive individualized dietary counseling. Subjects in the placebo group will be counseled to follow a hypocaloric diet.
16178388|NCT01559259|Drug|Ibuprofen|Two caplets of ibuprofen 200 mg
16174360|NCT01590394|Device|Large plastic biliary stent|Stent placement for bile duct obstruction.
16174361|NCT01590368|Device|Marketed electrode|12 electrodes will be placed on the subject for an ECG reading to be taken
16174362|NCT01590368|Device|"Modified test electrode"|12 electrodes with modified adhesive will be placed on the subject to allow an ECG reading to be taken
16174363|NCT01590355|Radiation|Radiotherapy|Gross Tumour and Nodes: 70 Gy in 35 fractions over 7 weeks. High-risk nodal areas: 63 Gy in 35 fractions over 7 weeks. Low-risk nodal areas: 56 Gy in 35 fractions over 7 weeks
16174364|NCT01590355|Procedure|Transoral Robotic Surgery + Neck Dissection|Transoral robotic excision will be carried out using the da Vinci surgical robot.
16174365|NCT01590342|Drug|Diclofenac|Diclofenac 75 mg, two doses
16174366|NCT01590342|Drug|Placebo|Placebo, two doses
16174367|NCT01590329|Device|Momelan Technologies Epidermal Graft Harvesting System|The procurement of the epidermal micro graft involves the use of MoMelan Technologies suction blister system, which consists of a control harvester. The device is applied to the subject's thigh to create blisters. The epidermal micrografts are then harvested and transferred to a commercially available sterile film dressing, placed on the surgical wound or prepared recipient site and the wound is then bandaged.
16174368|NCT01590316|Device|Cerebral NIRS oximetry|Cerebral NIRS oximetry during the first 72 hours of life.
16174369|NCT01590303|Drug|Vitamin C|Intravenous Vitamin C 1 gram every 8 hours for 28 days or discharge from intensive care unit
16174370|NCT01590303|Drug|placebo|placebo vehicle administered to match volume of treatment drug every 8 hours for 28 days or until discharge from ICU
16174371|NCT01590290|Other|financial compensation|financial monetary reimbursement
16174374|NCT01590264|Device|Bimodal rTMS|"High frequency (10 Hz) at 110% of the motor threshold TMS delivered over the left dorsolateral prefrontal cortex, subsequently, a low frequency TMS (1 Hz) at 110% motor threshold will be delivered over 31 minutes over the TPJ area, according to the protocol below.
~DLPFC Stimulation Frequency 10 Hz Intensity 110% of motor threshold On 5 seconds Off 15 seconds Total Trains 80 per session Total pulses session 4000/session Duration session 26.6 minutes Total pulses (study) 40000
~TPJ Stimulation Frequency 1 Hz Intensity 110% of motor threshold On 900 seconds Off 60 seconds Total Trains 2 per session Total Pulses session 1800 Duration session 31 minutes Total Pulses study 18000"
16174375|NCT01590251|Other|Yoga|Two yoga sessions per week for 8 weeks (one yoga session is instructional, the other is a practice session.
16174376|NCT01590251|Behavioral|Educational Counseling|One didactic session per week of approximately 50 minutes that provides information about chronic pain and substance abuse disorders.
16174377|NCT01590238|Biological|PRFM treatment|Study participants are treated in the initial visit, and at the 1 and 2 month follow-up visit. 4-8 cc of autologous platelet rich fibrin matrix (PRFM) is isolated from 9-18 cc of peripheral blood. PRFM is then injected intradermally in 0.10 cc aliquots in areas of alopecia for each treatment.
16174378|NCT01590225|Drug|Boceprevir|Boceprevir will be administered orally at a dose of 11.4 mg/kg three-times daily (TID) for 24 weeks. The boceprevir dose will be calculated based on 11.4 mg/kg and will then be rounded to the nearest 200-mg value for subjects in the oldest age group, or to the nearest 100-mg or 200-mg value for the subjects in the two youngest age groups.
16174379|NCT01590225|Drug|Peginterferon alpha-2b|Peginterferon alpha-2b will be administered subcutaneously at a dose of 60 μg/m^2 once weekly (QW) for 24 weeks.
16174380|NCT01590225|Drug|Ribavirin|The dose of ribavirin will be approximately 15 mg/kg/day administered orally in two divided doses (twice daily [BID]) for 24 weeks.
16174381|NCT01590225|Drug|Boceprevir|Boceprevir will be administered orally at a dose of 11.4 mg/kg three-times daily (TID) for up to 48 weeks. The boceprevir dose will be calculated based on 11.4 mg/kg and will then be rounded to the nearest 200-mg value for subjects in the oldest age group, or to the nearest 100-mg or 200-mg value for the subjects in the two youngest age groups.
16174382|NCT01590225|Drug|Peginterferon alfa-2b|Peginterferon alpha-2b will be administered subcutaneously at a dose of 60 μg/m^2 once weekly (QW) for 48 weeks.
16174383|NCT01590225|Drug|Ribavirin|"Drug: Ribavirin
~The dose of ribavirin will be approximately 15 mg/kg/day administered orally in two divided doses (twice daily [BID]) for 48 weeks."
16174384|NCT01590212|Other|Mellow Bumps|Mellow Bumps is a six week group-based antenatal programme designed to support families with additional health and social care needs. It is intended to decrease maternal antenatal stress levels, increase expectant mothers' understanding of neonates' capacity for social interaction and emphasise the importance of early interaction in enhancing brain development and attachment. It is delivered non-didactically to maximise participant engagement and rapport. Each week there is one activity focused on the woman and another on a baby-related topic. The programme is designed to be offered between twenty to thirty weeks' gestation, to capture the period when the risk of miscarriage is low and fetal movement felt, but before major preoccupation with the delivery.
16174385|NCT01590212|Other|Chill-out in Pregnancy|Chill Out in Pregnancy (ChIP) is a relaxation programme that includes all the mother centred components of Mellow Bumps but none of the baby / mother-baby relationship components. It also runs for six weeks at two hours per week and is intended to decrease stress levels.
16174386|NCT01590199|Drug|RAD001|
16174387|NCT01590199|Drug|SOM230|
16174388|NCT01590173|Drug|Prednisolone and Heparin during COH for IVF|Low Molecular Weight Heparin (LMWH) (Enoxaparin Sodium, Clexane, Sanofi-Aventis, Australia) at a dose of 1 mg/kg/day and 5 mg prednisolone p.os (Prezolon; Nycomed Hellas SA) were to be initiated on the first day of injections in both protocols until the pregnancy test. In cases of pregnancy, prednisolone and enoxaparin were to be continued up to the 12th and 34th week, respectively
16174420|NCT01589991|Drug|Toothpaste|The volunteers brushed their teeth with 0.3 g of the assigned toothpastes, 3x/day.
16174456|NCT01589640|Other|Blink Gel Tears Lubricating Eye Drops|2 drops per eye dosed four times per day (8:00 AM, 12:00PM, 4:00 PM and 8:00 PM)
16174389|NCT01590173|Drug|COH for IVF|Both GnRH agonists (long, starting at day 2 or 21) with Triptorelin acetate 0.1 mg (Gonapetpyl daily; Ferring, Kiel, Germany) and antagonists' with ganirelix 0.25 mg (Orgalutran; Organon, Oss, The Netherlands) or cetrorelix 0.25 mg (Cetrotide; Serono, Rome, Italy) protocols will be used; for ovarian stimulation both recombinant FSH (Puregon; Organon, Oss, Netherlands or Gonal F; Serono, Rome, Italy) and human menopausal gonadotrophin (Menopur; Ferring Pharmaceuticals, Langley, Berkshire, UK) will be used. Ovarian response will be monitored by ultrasonography, oocyte retrieval will be performed 36-38 hours after the hCG triggering and for luteal phase support 600 mg progesterone tablets (Utrogestan; Laboratoires Besins- Iscovesco, Paris, France) or gel 8% intravaginally (Vasclor; Verisfield Ltd, UK) will be applied.
16174390|NCT01590160|Drug|Ganetespib|IV, Using dose from Phase I
16174391|NCT01590147|Procedure|Yoga therapy|receive YST
16174392|NCT01590147|Other|questionnaire administration|Ancillary studies
16174393|NCT01590147|Procedure|quality-of-life assessment|Ancillary studies
16174394|NCT01590147|Other|laboratory biomarker analysis|Correlative studies
16174395|NCT01590147|Other|assessment of therapy complications|Ancillary studies
16174396|NCT01590147|Procedure|management of therapy complications|Receive YST or CE
16174397|NCT01590147|Other|educational intervention|Receive CE
16174398|NCT01590134|Dietary Supplement|Dietary supplement of iron|1 tablespoon of a dietary iron supplement containing 2.64mg of elemental iron
16174399|NCT01590134|Drug|Ferrous sulphate|200mg coated dried tablet containing 65mg elemental iron, equivalent to prophylactic daily dose as defined by the British National Formulary
16174400|NCT01590121|Other|Aeroplane flight in the past- no active intervention for study|Aeroplane flight(s) previously taken by study participants
16174401|NCT01590121|Other|Questionnaire|Flight by aeroplane (previous)
16174402|NCT01590108|Drug|(Pyr1)apelin-13|(Pyr1)apelin-13 will be infused at 30 nanomol/min intravenously. This dose has been used in healthy volunteer and patients groups
16174403|NCT01590108|Drug|Saline|Saline
16174404|NCT01590095|Behavioral|Water quality|"Hardware: Free supplies chlorine tablets (Aquatabs; NaDCC) and a safe storage vessel to treat and store drinking water.
~Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the treatment of all drinking water for children < 36 months of age."
16174405|NCT01590095|Behavioral|Sanitation|Hardware: Free child potties, sani-scoop hoes to remove feces from household environments, latrine upgrades to a dual pit latrine Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the use of latrines for defecation and the removal of human and animal feces from the compound.
16174406|NCT01590095|Behavioral|Hand washing|"Hardware: Hand washing stations, soapy water bottles located at hand washing locations, detergent soap to supply soapy water bottles.
~Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on hand washing with soap at critical times around food preparation, defecation, and contact with feces."
16174407|NCT01590095|Behavioral|Water quality, Sanitation, Hand washing (Combined WASH)|"Hardware: Free supplies Aquatabs; (NaDCC) and a safe storage vessel to treat and store drinking water. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the treatment of all drinking water for children < 36 months of age.
~Hardware: Free child potties, sani-scoop hoes to remove feces from household environments, latrine upgrades to a dual pit latrine. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on the use of latrines for defecation and the removal of human and animal feces from the compound.
~Hardware: Hand washing stations, soapy water bottles located at hand washing locations, detergent soap to supply soapy water bottles. Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages that focus on hand washing with soap at critical times around food preparation, defecation, and contact with feces."
16174408|NCT01590095|Behavioral|Nutrition|"Supplement: Lipid-based Nutrient Supplement (LNS) delivered daily from ages 6 to 24 months.
~Promotion: Local promoters will visit study compounds at least monthly to deliver behavior change messages modeled on those recommended in the Guiding Principles for Complementary Feeding of the Breastfed Child and the recent UNICEF Program Guide for Infant and Young Child Feeding Practices.General messages will include (1) practice exclusive breastfeeding from birth to 6 months of age and introduce complementary foods at 6 months of age while continuing to breastfeed; (2) continue breast feeding as you did before receiving LNS; (3) provide your child micronutrient-rich foods such as meat, fish, eggs, and vitamin A rich fruits and vegetables; and (4) feed your child at least 2-3 times per day when 6-8 months old and 3-4 times per day when 9-24 months old."
16174409|NCT01590095|Behavioral|Nutrition, Water quality, Sanitation, Hand washing|Each of the interventions described above for Water Quality, Sanitation & Hand washing (Combined WASH) Plus the intervention described above for nutrition.
16174410|NCT01590082|Drug|Doxycycline|"Phase I Starting Dose: 200 mg by mouth twice a day on Day -6 of Cycle 1 (1 week before Day 1 of Cycle 1 starts)
~Phase II Starting Dose: Maximum Tolerated Dose (MTD) from Phase I."
16174411|NCT01590082|Drug|Ipilimumab|Phase I and II: 3 mg by vein on Day 1 of each 21 day cycle for 4 cycles.
16174412|NCT01590082|Drug|Temozolomide|Phase I and II: 200 mg/m2 by mouth on Days 1 - 4 of each 21 day cycle for 4 cycles.
16174413|NCT01590069|Biological|Aerosolized Aldesleukin|Breathe aerosolized aldesleukin
16174414|NCT01590069|Other|Laboratory Biomarker Analysis|Optional correlative studies
16174415|NCT01590056|Other|Electrophysiological recording|"During the surgery for bilateral DBS electrode implantation, electrophysiological recording from the STN will be made while patients are:
~listening to nonverbal affect bursts corresponding to emotions
~applying a simple go-no-go auditory test"
16174416|NCT01590043|Other|Salivary samples|Each participant will give a sample of saliva through spitting for 5 minutes in a sterile tube.
16174417|NCT01590030|Procedure|Laparoscopic dermoid cystectomy|Laparoscopy will be performed by pneumoperitoneum with CO2. A complete pelvic examination will be performed to exclude malignant disease. Ovarian capsule will be incised by scissors on mesial side in study group and antimesial side in control group. After cleavage plane identification the cyst enucleation will be completed by atraumatic dissection.
16174418|NCT01590017|Drug|cisplatin|
16174419|NCT01590017|Radiation|external beam radiation therapy|
16174943|NCT01585727|Procedure|Neuromonitoring|Intraoperative neuromonitoring of pelvic autonomic nerves.
16174421|NCT01589978|Device|PROMUS Element Plus Coronary Stent System|PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent) and a drug product (a formulation of everolimus contained in a polymer coating).
16174422|NCT01589978|Drug|Aspirin|Aspirin should be taken daily (81 mg) for 3 days prior to the procedure or as a peri-procedural loading dose of 250-500 mg. A maintenance dose of aspirin of at least 81 mg daily, or as indicated by the treating physician, should be continued indefinitely.
16174423|NCT01589978|Drug|P2Y12 antagonist|"Patients to take one of the following P2Y12 antagonists; maintenance doses to be continued per ACC/AHA/SCAI guidelines for PCI.
~Clopidogrel: Per treating physician, peri-procedural loading dose (300-600 mg), subsequent maintenance dose (75 mg daily)
~Prasugrel: Per treating physician, peri-procedural loading dose (60 mg), subsequent maintenance dose (10 or 5 mg daily per product labeling)
~Ticagrelor: Per treating physician, peri-procedural loading dose (180 mg), subsequent maintenance dose (90 mg 2x daily); maintenance aspirin doses >100 mg may reduce ticagrelor effectiveness and should be avoided.
~Ticlopidine: Per treating physician, if allergy/intolerance to clopidogrel, prasugrel, and/or ticagrelor, loading dose (500 mg), subsequent maintenance dose (250 mg 2x daily)"
16174424|NCT01589965|Behavioral|Financial incentive through lotteries|Introduction of financial incentives in the form of a lottery to remain/become STI-negative, which we believe is both replicable and relatively easy to scale-up.
16174425|NCT01589952|Drug|Pegalyted interferon, Entecavir|Pegalyted interferon: 90 micro gms subcutaneously once weekly for 24 weeks Entecavir: 0.5 mg orally once daily for 24 weeks
16174426|NCT01589926|Device|Bi-level positive airway pressure device|BiPAP initiated for at least 16 hours per day for a minimum of 48hrs.
16174427|NCT01589926|Device|Sham CPAP|Sham CPAP initiated for at least 16 hours per day for a minimum of 48hrs.
16174428|NCT01589913|Behavioral|ICD-Forum|"The CBT based internet program ICD-Forum is designed to increase QoL, and decrease anxiety and depression in ICD-patients. The program includes a therapist moderated asynchronous discussion group and content focused modules following a six weeks schedule:
~Introduction to participants and online system
~Knowledge regarding ICDs
~Strategies for behavior change
~Psychological models for anxiety and depression
~Strategies to cope with avoidance, anxiety and depression
~Resume, evaluation, resolution of open questions, goal setting, good bye"
16174429|NCT01589861|Drug|BKM120 + lapatinib|BKM120 40, 60 or 80 mg/day per os for 28 days cycle associated to lapatinib 750, 1000 or 1250 mg/day per os for 28 days cycle until progression or toxicity
16174430|NCT01589835|Behavioral|Lifestyle changes|Green prescription with support from facilitator
16174431|NCT01589822|Biological|EVICEL Fibrin Sealant|Intraoperative
16174432|NCT01589809|Drug|nicotinamide|dose-escalation, 2-8 grams, oral
16174433|NCT01589796|Procedure|TAP block|injection of 20ml of Ropivacaine 0.5% in the proper place once it is identified
16174434|NCT01589783|Other|completion of a questionnaire|Completion of a questionnaire
16174435|NCT01589783|Other|Blood draw|A subset of 100 women will have a blood test to measure Vitamin D levels
16174436|NCT01589770|Other|cardiac Magnetic Resonance imaging|
16174437|NCT01589757|Other|Standard Care|Standard dietary advice for women with GDM with special emphasis on use of high fiber or whole grain carbohydrate foods with a medium to high GI. What's on Your Plate? and 3-dimensional food models will be used to teach servings size and meal planning. This groups will be provided with food substitution lists (key-foods method) composed of medium to high GI foods.
16174438|NCT01589757|Other|Low GI diet|"Nutrition education according to standard care similar to the control group with supplementary GI-education. GI-education will be taught using the Stop-Light-Method. This groups will be provided with food substitution lists (key-foods method) composed of low-GI carbohydrate-containing food. The GI-education tool(s) will build on standard care education where patients are taught which food groups contain carbohydrate."
16174439|NCT01589744|Device|Suction cup Hemostatic Intra-Uterine, device not marked CE (not marketed)|The haemostatic intra-uterine suction-cup is introduced in uterus and a depressure in this device is applied. This medical device is used for 5 minutes at maximum.
16174440|NCT01589718|Drug|Macugen|one intravitreal injection of Macugen prior to vitrectomy surgery
16174441|NCT01589718|Drug|Sham|The subject in cohort 2 will receive one sham comparator, sham injection prior to vitreous surgery.
16174442|NCT01589692|Procedure|Open Reduction and Internal Fixation|Internal fixation with a volar locking plating system
16174443|NCT01589692|Procedure|External Fixation|External Fixation with a bridging external fixator. Can be done with or without percutaneous pinning.
16174444|NCT01589692|Procedure|Percutaneous Pinning|Pinning with any number of Kirschner wires
16174445|NCT01589692|Procedure|Closed Reduction and casting|Closed reduction and immobilization with a cast and/or splint
16174446|NCT01589679|Other|standard of care|Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. This unit is work for 60 minutes three times per day.
16174447|NCT01589679|Device|Metarsal Dynasplint|Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. This unit is work for 60 minutes three times per day.
16174448|NCT01589666|Biological|Spray-dried S/D-treated Plasma|Infusion of 100 mL Spray-dried S/D-treated Plasma
16174449|NCT01589666|Drug|Spray-dried S/D-treated plasma|Infusion of 200mL Spray-dried S/D-treated plasma
16174450|NCT01589666|Biological|Spray-dried S/D-treated Plasma|Infusion of 500 mL Spray-dried S/D-treated plasma
16174451|NCT01589666|Biological|Spray-dried S/D-treated Plasma|Infusion of 750 mL Spray-dried S/D-treated Plasma
16174452|NCT01589666|Biological|Spray-dried S/D-treated Plasma|Infusion of 800 mL Spray-dried S/D-treated Plasma
16174453|NCT01589653|Drug|biphasic insulin aspart 30|Dose individually adjusted by the subjects themselves according to the titration algorithm every second week. Administered subcutaneously (s.c., under the skin) twice daily.
16174454|NCT01589653|Drug|biphasic insulin aspart 30|Dose individually adjusted according to the directions given by the investigator. Administered subcutaneously (s.c., under the skin) twice daily.
16174455|NCT01589640|Other|Blink Tears lubricating Eye Drops|2 drops per eye drosed four times per day (8:00 Am, 12:00 PM, 4:00 PM and 8:00 PM)
16175125|NCT01584154|Procedure|cryoablation|cryoablation with an 8mm-tip catheter
16174457|NCT01589640|Other|Systane Balance Lubricant Eye Drop|2 Drops per eye dosed four times per day ( 8:00 AM, 12:00 PM, 4:00 PM and 8:00PM)
16174458|NCT01589627|Device|Wrist Extension Dynasplint|Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. The Knee Extension Dynasplint for the Experimental group will have tension chambers delivering therapeutic treatment from the device.
16174459|NCT01589614|Drug|PH-797804|Tablet, 6mg, single
16174460|NCT01589614|Drug|PH-797804 + erythromycin|PH-797804: tablet, 6mg, single erythromycin: tablet, 400 mg, multiple
16174461|NCT01589601|Behavioral|Usual heart failure care|Usual heart failure care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention.
16174462|NCT01589601|Behavioral|Interdisciplinary palliative care|Interdisciplinary palliative care focused on symptom relief; assessment and management of anxiety, depression, and spiritual concerns; as well as advance care planning that includes definition of care goals, resuscitation preferences, and participation in the Outlook intervention.
16174463|NCT01589588|Device|Open Hudson Mask|Mask type 1 oxygen
16174464|NCT01589588|Device|Cluster headache mask with 3 L reservoir|Mask type 2 with oxygen
16174465|NCT01589588|Device|Mask 3|Mask type 3 oxygen
16174466|NCT01589588|Device|Carnét oxygen demand valve|mask type 3 oxygen
16174467|NCT01589588|Device|Carnét oxygen demand valve|mask type 3 placebo
16174468|NCT01589562|Drug|Megace 800mg/20ml|Megestrol acetate 800mg/20ml, Suspension, Single dose
16174469|NCT01589562|Drug|DW-ES(B) 625mg/5ml|Megestrol acetate 625mg/5ml, Nano suspension, Single dose
16174470|NCT01589549|Biological|Mesenchymal stromal cell therapy|One arm will be randomised to receive mesenchymal stromal cell therapy in addition to corticosteroid therapy
16174471|NCT01589536|Other|interval-rehabilitation|The Patients in the intervention group receive a Stationary psychocardiological interval-rehabilitation.The Interval rehabilitation is divided into individual psychological therapy with focus of Behavior therapy and relaxation therapy.
16174472|NCT01589523|Drug|Glycocholic Acid|10-15mg/kg body weight/day taken orally. Supplied as either liquid or 50mg capsules.
16174473|NCT01589510|Drug|bimatoprost 0.01% ophthalmic solution|Bimatoprost 0.01% ophthalmic solution (Lumigan® 0.01%) as prescribed by physician per standard practice for up to 14 weeks.
16174474|NCT01589497|Drug|Rifampicin|Participants with body weight </= 50kg were administered one 450 mg tablet orally once daily. Participants with body weight >50kg were administered one 600 mg tablet orally once daily.
16174475|NCT01589497|Drug|Isoniazid|Participants were administered three 100 mg tablets or one 300 mg tablet once daily.
16174476|NCT01589497|Drug|Pyrazinamide|Participants with a body weight of 40-55 kg were administered two 500 mg tablets orally once daily. Participants with a body weight of 56-75 kg were administered three 500 mg tablets orally once daily. Participants with a body weight of 76-90 kg were administered four 500 mg tablets orally once daily.
16174477|NCT01589497|Drug|Ethambutol|Participants with a body weight of 40-55 kg were administered two 400 mg tablets orally once daily. Participants with a body weight of 56-75 kg were administered three 400 mg tablets orally once daily. Participants with a body weight of 76-90 kg were administered four 400 mg tablets orally once daily.
16174478|NCT01589497|Drug|Moxifloxacin|Participants were administered one 400 mg tablet orally once a day.
16174479|NCT01589484|Device|SWL - Compact Delta Dornier Med Tech|All patients will be submitted to a noncontrast computed tomography before to SWL. Patients will be submitted to SWL under the following conditions: outpatient, general anesthesia, 3000 impulses, rate of 90/min, discharged from hospital in the same day with alpha-blocker (doxazosin) during 30 days.
16174480|NCT01589471|Drug|intra-rectal Botulinum toxin A injection|intra-colic injection of 100 U of Botulinum toxin A as a single injection distributed amongst the four quadrants, 5 cm above anastomosis
16174481|NCT01589458|Drug|Toothpaste|1-min brushing with 1 g of the assigned toothpaste followed by a 10 mL purified water rinse
16174482|NCT01589445|Drug|Pioglitazone hydrochloride|77 patients were treated with pioglitazone hydrochloride (B001) for 3 months.Biomedical parameters were measured each month.
16174483|NCT01589445|Drug|Metformin hydrochloride|After the treatment with pioglitazone(001) for 3 months first and then patients were on one month washout period;in the washout period they were given metformin tablet 850mg once daily,then treated with 002 (metformin) for further 3 months. The same biomedical measurements were assayed.
16174484|NCT01589432|Drug|ABT-639|two 50 mg oral capsules
16174485|NCT01589432|Drug|Placebo|2 placebo capsules
16174486|NCT01589432|Drug|Lidocaine|3mg/kg infusion over 30 minutes
16174487|NCT01589419|Drug|veliparib|see arm description
16174488|NCT01589419|Drug|capecitabine|see arm description
16174489|NCT01589419|Radiation|radiation|see arm description
16174490|NCT01589393|Drug|Enoxaparin|Enoxaparin 30 mg subcutaneously twice daily for six doses starting 36-48 hours post traumatic injury.
16174491|NCT01589393|Other|Placebo|0.9% normal saline in equal volume to active comparator given subcutaneously twice daily starting 36-48 hours post traumatic injury for six doses.
16174492|NCT01589380|Drug|Fimasartan|"Fimasartan, Initial dose will be started with 30mg per day. At 12 months follow-up after the enrollment, dose titration up to 60 mg per day will be made with target blood pressure of 120/80.
~Dose escalization from 30mg/day to 60mg/day will be performed in the case of follow-up systolic blood pressure is over 120. If the follow-up systolic blood pressure is less than 120, initial dose of 30mg/day will be maintained throughout the study duration. If hypotension (BP < 90/60) is developed, the study medication will be discontinued and the patient will be included safety outcome analysis and intention to treat analysis. Per protocol analysis will be also performed. The dose of placebo will be adjusted identically, according to the blood pressure criteria of fimasartan."
16174493|NCT01589380|Drug|Placebo|Placebo was used in phase 3 clinical trial of fimasartan (NCT00922480, NCT01135212, and NCT01258673). The same placebo, which is manufactures at Boryoung pharmaceutical company, will be used in this trial. After enrollment and randomization, placebo will be administered one capsule once daily in placebo group.
16174718|NCT01587404|Device|THERMOCOOL® SMARTTOUCH™ Catheter (including Surround Flow)|Variable contact force as measured at the catheter tip within the left atrium
16174494|NCT01589367|Drug|Metformin|Metformin HCl 500mg(morning/evening) PO daily x 1week Metformin HCl 1000mg(morning)and 500mg(evening)PO daily x 1week Metformin HCl 1000mg(morning/evening) PO daily x 22weeks
16174495|NCT01589367|Drug|Placebo|Letrozole 2.5mg PO daily + Placebo 1 tablet PO 2/day x 1week Letrozole 2.5mg PO daily + Placebo 2 tablet+ 1 tablet PO x 1 week Letrozole 2.5mg PO daily + Placebo 2 tablet PO 2/day x 22 weeks
16174496|NCT01589354|Procedure|Interscalene brachial plexus block|An interscalene block will be performed pre-operatively using ultrasound guidance and the peripheral nerve stimulator (with the patient awake) using 20 ml of 0.375% Ropivacaine.
16174497|NCT01589354|Procedure|Intra-articular Ropivacaine injection|The procedure will be done by the surgeon at the end of the operation, with an intra-articular injection of 20 ml 0.75% Ropivacaine through the arthroscopic cannula after closure of the anterior wound
16174498|NCT01589354|Device|Ultrasound guided technique|The block will be performed under U/S guidance
16174499|NCT01589354|Drug|Ropivacaine|20ml of 0.375% Ropivacaine
16174500|NCT01589354|Drug|Ropivacaine|20ml of 0.75% Ropivacaine injected by the surgeon at the end of the procedure
16174501|NCT01589341|Other|laboratory biomarker analysis|Correlative studies
16174502|NCT01589328|Other|Early Palliative care integrated with usual oncologic care|"Drug: The interventions consisted of the following:
~(1) Nursing assessment of pain and depression mood (2) Pain control based NCCN guideline (3) Depression control by psychoeducation and/or consultation of psychiatrist specialist (4) Patient education"
16174503|NCT01589315|Device|focal ECT|FEAST, ECT, unidirectional stimulation
16174504|NCT01589302|Drug|ibrutinib|Patients receive ibrutinib orally (PO) once daily (QD) on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
16174505|NCT01589302|Other|Correlative laboratory samples|Blood samples will be collected and used for pharmacodynamic testing. Samples will be collected pre-dose on Cycle 1 Day 1 and 2 hours post-dose Cycle 1 Day 1, pre-dose on Day 2 and Day 8 of Cycle 1 and pre-dose on Day 1 of Cycles 2 and 3 and then every 3 cycles thereafter for 1 year (Cycle 15 Day 1). Samples will also be collected at the time of relapse and at any time when bone marrow biopsy is performed.
16174506|NCT01589302|Other|quality of life assessment|During screening, sociodemographic information (e.g., age, race, marital status) and reports of recent (last year) stressful events will be obtained. The assessment will consist of measures of emotional distress, depressive symptoms, and quality of life. Quality of life measures will be administered during screening and on Days 1 (±3), 8 (±3),, 15 (±3),, 22 (±3), of Cycle 1, Day 1 (±3), of Cycle 2 and on day 1 (±7) of Cycles 3, 6, and then every 3 months thru month 24.
16174507|NCT01589289|Device|Immunochromatographic HAT tests (DSD)|Immunochromatographic HAT diagnostic tests manufactured by DSD, Korea and FIND
16174508|NCT01589289|Device|Card Agglutination Trypanosoma Test|Card Agglutination Trypanosoma Test on whole blood and as dilution
16174509|NCT01589289|Device|TB POC Nucleic Acid Amplification Test (Molbio Diagnostics)|"TB POC Nucleic Acid Amplification Test: microPCR handheld device (Molbio Diagnostics PVT ltd, India)"
16174510|NCT01589289|Device|TB 3-marker RDT (Tulip diagnostics)|TB 3-marker RDT: ADA2/IFN-g/LAM (Tulip diagnostics, ltd, India) - pending availability for phase 3 validation
16174511|NCT01589289|Device|Cryptococcal Antigen Lateral Flow Assay (Immy)|Cryptococcal Antigen Lateral Flow Assay (Immy, USA)
16174512|NCT01589263|Drug|onaBoNT-A + placebo|"200 U prostate injection once
~Arms: ARM 1: onaBoNT-A + placebo"
16174513|NCT01589263|Drug|Tamsulosin + placebo|0.4 mg capsule daily for 3 months Arms: ARM 2: Saline + Tamsulosin
16174514|NCT01589237|Drug|LCQ908|
16174515|NCT01589211|Behavioral|Brief advice|Brief advice of about 10 min accompanied by self-help material
16174516|NCT01589211|Behavioral|Compact cessation course|Compact cessation course on the basis of Motivational Interviewing (MI) and Cognitive Behavioural Therapy (CBT). Group setting. 2 x 120 min.
16174517|NCT01589211|Behavioral|Standard cessation course|Cessation course over 6 dates. Group setting.
16174518|NCT01589185|Drug|KBSA301|KBSA301 administered as a single intravenous infusion at dose 1, 2, 3 and 4.
16174519|NCT01589185|Drug|Placebo|Placebo administered as a single intravenous infusion
16174520|NCT01589159|Drug|Capecitabine|Drug:capecitabine 700mg/m2, twice daily on days 1-14.
16174521|NCT01589159|Drug|Etoposide|Etoposide 30mg/m2, once daily on days 1-7.
16174522|NCT01589146|Drug|Heparin, Low-Molecular-Weight|4 weeks heparin prophylaxis
16174523|NCT01589120|Behavioral|Video decision aid|Video decision aid of the goals of care
16174524|NCT01589107|Behavioral|video decision aid|video decision aid
16174525|NCT01589094|Drug|Gemcitabine and Cisplatin (DD GC)|Patients will receive six cycles of GC administered every 14 days. Gemcitabine 2,500 mg/m2 will be administered intravenously on day 1 and cisplatin 35 mg/m2 will be administered intravenously on days 1 and 2 of a 14 days cycle (with Peg GCSF). A total of six cycles of therapy will be administered followed by radical cystectomy with bilateral pelvic lymph node dissection (PLND)
16174526|NCT01589081|Drug|Intravenous Nicotine|Subjects will be given an IV challenge dose of nicotine or placebo in a constant volume of 2 mL on any study session day. The nicotine solutions (1.0 mg/70kg or 1.5 mg/70kg or 2.0 mg/70kg) will be administered over 1 min. This rate of drug delivery (2 mL over one minute) has been safe in our IRB-approved studies of nicotine. Most investigators have administered nicotine over 10 seconds without any adverse reactions. We concur with the IRB recommendation that the lower doses (1.0 mg/70kg; and 1.5 mg/70kg) will be administered first and the higher dose (2.0 mg/70kg) will be administered last.
16174527|NCT01589081|Drug|Progesterone|To stimulate the luteal phase of the menstrual cycle, Prometrium capsules containing 200 mg of micronized progesterone or placebo (lactose containing) capsules will be administered orally at 120 minutes before the injection of IV nicotine.
16174528|NCT01589068|Drug|Intravenous Nicotine|Subjects will be given an IV challenge dose of nicotine or placebo in a constant volume of 2 mL on any study day. The nicotine solution (1.0 mg/70kg or 1.5 mg/70kg or 2.0 mg/70kg) will be administered over 1 min. This rate of drug delivery (2 mL over one minute) has been safe in our IRB-approved studies of nicotine. Most investigators have administered nicotine over 10 seconds without any adverse reactions. We concur with the IRB recommendation that the lower doses (1.0 mg/70kg and 1.5 mg/70 kg) will be administered first and the higher dose (2.0 mg/70kg) will be administered last.
16174719|NCT01587391|Drug|Placebo to BI 163538 XX|1 single dose per subject as oral solution
16174529|NCT01589068|Drug|Progesterone|To stimulate the luteal phase of the menstrual cycle, Prometrium capsules containing 200 mg of micronized progesterone or placebo (lactose containing) capsules will be administered orally at 120 minutes before the injection of IV nicotine.
16174530|NCT01589055|Drug|Intravenous Nicotine|Subjects will be given an intravenous challenge dose of nicotine or placebo in a constant volume of 1 ml on any study day. The nicotine solution (1.0 mg/70kg or 1.5 mg/70kg or 2.0 mg/70kg) will be administered over 1 min. This rate of drug delivery (1 ml over 1 min) has been safe in our IRB approved studies of nicotine. Most investigators have administered nicotine over 10 sec without any adverse reactions. We concur with the IRB recommendation that the lower doses (1.0 mg/70kg and 1.5 mg/70kg;) should be administered first and the higher dose (2.0 mg/70kg) will be administered last.
16174531|NCT01589029|Drug|CANAKINUMAB (ILARIS®)|subcutaneous injection every 8 weeks
16174532|NCT01589003|Other|Low Glycaemic index growing up milk|Low Glycaemic index growing up milk
16174533|NCT01589003|Other|High GI growing up milk|High glycaemic index growing up milk
16174534|NCT01588990|Drug|Oxaliplatin|Participants will receive oxaliplatin 85 milligrams per square meter (mg/m^2) IV infusion on Day 1 of every 2 weeks cycle during alternative Phase A treatment or 130 mg/m^2 on Day 1 of every 3 weeks cycle during Phase A treatment.
16174535|NCT01588990|Drug|Capecitabine|Participants will receive capecitabine 1000 mg/m^2 per oral (PO) twice daily on Days 1-14 of 3 weeks cycle during Phase A treatment.
16174536|NCT01588990|Drug|Bevacizumab|Participants will receive 7.5 mg/kg IV infusion on Day 1 every 3 weeks (Phase A treatment) or 5 mg/kg IV on Day 1 every 2 weeks (Alternative Phase A treatment and Phase B).
16174537|NCT01588990|Drug|Leucovorin|Participants will receive leucovorin 400 mg/m^2 IV on Day 1 every 2 weeks (Alternative Phase A treatment and Phase B). Investigators may elect to chose low dose of leucovorin (either 20 mg/m^2 or 50 mg total dose).
16174538|NCT01588990|Drug|5-Fluouracil|Participants will receive 5-fluouracil loading dose of 400 mg/m^2 IV on Day 1 followed by 2400 mg/m^2 continuous IV infusion over 46 hours Day 1 (Alternative Phase A treatment and Phase B).
16174539|NCT01588990|Drug|Irinotecan|Participants will receive irinotecan 180 mg/m^2 IV on Day 1 every 2 weeks during Phase B treatment.
16174540|NCT01588964|Procedure|HIPEC|surgery plus HIPEC with the closed technique(perfusion of the abdominal cavity with a solution containing oxaliplatin 460 mg/m2 in 2L/m2 heated saline at 42°C).The global temperature will be measured by thermometer inserted into the esophagus and rectum. A Swan-Ganz catheter will be kept in place during the HIPEC for monitoring cardiovascular function.
16174541|NCT01588951|Drug|Cytarabine consolidation|Cytarabine-based consolidation per institutional standards.
16174542|NCT01588951|Drug|Allogeneic transplant|Allogeneic stem cell transplant per institutional standards.
16174543|NCT01588925|Device|Cochlear Implantation|Cochlear implantation using Hybrid L24 Implant
16174544|NCT01588925|Drug|Cochlear Implantation+dexamethasone|Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window
16174545|NCT01588925|Drug|Cochlear Implantation+dexamethasone+hyaluronic acid|Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window and hyaluronic acid (10mg/ml) in the electrode array
16174546|NCT01588912|Drug|Telbivudine|If virologic response, which means HBV DNA < 50 IU/mL, is shown at 24 weeks, telbivudine monotherapy is maintained and in the event that virologic response is not shown, tenofovir add-on therapy is done
16174547|NCT01588912|Drug|Tenofovir|If virologic response, which means HBV DNA < 50 IU/mL, is shown at 24 weeks, telbivudine monotherapy is maintained and in the event that virologic response is not shown, tenofovir add-on therapy is done
16174548|NCT01588912|Drug|Entecavir|Maintain the entecavir through the study period
16174549|NCT01588899|Device|MR-HIFU uterine fibroid treatment|A single treatment session for uterine fibroids with the MR-HIFU device.
16174550|NCT01588873|Drug|oc:E-E-desogestrel/vaginal ring:E-E -ethonogestrel|"The OC or vaginal ring will be used in 9 weeks periods followed by one week's break each.
~After a wash-out period of at least 2 months of any previous hormonal contraceptives all examinations will be performed at the 1st to 5th day of the menstruation cycle at baseline and then at the 9th, 29th and 59th week and the last 1 month after stopping contraception.
~Blood samples will be collected between 07 and 10 AM after an overnight fast and during the follicular phase or at any time in cases of amenorrhea. After centrifugation serum is filled in eight tubes with at least 2 ml of serum in each, and immediately frozen at -70ºC as well as one tube of plasma. Every tube will be marked appropriately. Fasting plasma glucose and HbA1c will be analysed at once at every appointment."
16174551|NCT01588847|Procedure|Spinal anesthesia with Bupivacaine hyperbar 0.5 %|Spinal anesthesia with Bupivacaine hyperbar 0.5 %
16174552|NCT01588847|Procedure|General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane|General anesthesia with Sufentanil, Propofol and Rocuronium and Sevoflurane
16174553|NCT01588834|Procedure|breast biopsy|ultrasound-guided core needle biopsy of healthy, mammographically dense breast tissue
16174554|NCT01588821|Drug|Cabozantinib|60 mg daily by mouth
16174555|NCT01588808|Behavioral|Immobilization|Immobilization with protein (elderlY), immobilization without protein (elderly and young)
16174556|NCT01588795|Procedure|Percutaneous renal denervation and TMNS|Patients are treated with the renal denervation procedure after randomization and are maintained on standardized anti-proteinuric medications
16174557|NCT01588795|Drug|Standardized antiproteinuric medication regimen includes an angiotensin receptor blocker , a diuretic , 25OH vitamin D3 and a statin|Patients are maintained on Standardized antiproteinuric medication regimen includes an angiotensin receptor blocker (irbesartan 300mg), a diuretic (furosemide 40mg or indapamide LP 1.5mg according to the eGFR), 25OH vitamin D3 and a statin (atorvastatin 20mg)
16174558|NCT01588782|Drug|Period 1: Abiraterone|1000 mg abiraterone acetate tablet administered orally on Day 1
16174559|NCT01588782|Drug|Period 2: Abiraterone/Ketoconazole|400 mg ketoconazole tablets administered orally on Days 11 to 16
16174560|NCT01588782|Drug|Period 2: Abiraterone/Ketoconazole|1000 mg abiraterone acetate tablet administered orally on Day 14
16174561|NCT01588769|Biological|ALECSAT cell based immunotherapy|I.V. injected Cell Based Medicinal Product, containing between 10 million and one billion autologous Cytotoxic T cells and Natural Killer cells.
16174562|NCT01588756|Drug|AcSDKP-NH2 inuline|Once intravenous administration of 100 µg or less
16174563|NCT01588756|Drug|AcSDKP-NH2 Cr-EDTA|Once intravenous administration of 100 µg or less
16174564|NCT01588743|Drug|insulin aspart|Insulin Aspart will be administrated by insulin pump with an initial dose of 0.4-0.6u/kg body weight, of which 50% basal rate and the other 50% bolus dose. Time interval for administration will be as follows: 0-3Am-9Am-12Am-5Pm-9Pm-0Am. Specific adjustment will be made according to individual difference.
16174565|NCT01588730|Device|Ankle Dorsiflexion Dynasplint|Dynamic Splinting utilizes the protocols of Low-Load, Prolonged-Duration Stretch (LLPS) with calibrated, adjustable tension to increase the Total End Range Time (TERT) to reduce contracture. This unit is worn at night while sleeping (6-8 hours) and, this does not affect activities of daily living
16174566|NCT01588730|Procedure|Commercially Available Static Night splint|A commericially avilable static night splint will be worn for 4-6 hours during rest.
16174567|NCT01588717|Drug|Glycopyrrolate|glycopyrrolate 2 to 6mg/day
16174568|NCT01588704|Drug|Neoadjuvant Bevacizumab|Neoadjuvant Pemetrexed, Carboplatin and Bevacizumab followed by surgical resection
16174569|NCT01588691|Device|Eon-mini IPG (implantable pulse generator)|programming parameters set at low frequency. Patients will receive this therapy dose for 3 weeks.
16174570|NCT01588691|Device|Eon-mini IPG (implantable pulse generator)|programming parameters set at high frequency. Patients will receive this therapy dose for 3 weeks.
16174571|NCT01588691|Device|Eon-mini IPG (implantable pulse generator)|programming parameters set at lowest settings to deliver minimal power. Patients will receive this therapy dose for 3 weeks.
16174572|NCT01588678|Drug|DS-3078a|DS-3078a will be administered as oral capsules once daily and will be supplied in 5, 20, 50, and 150 mg capsules.
16174573|NCT01588639|Drug|Insulin (Scilin N, BAY81-9924)|Subjects are treated with recombinant human insulin-SciLin N, SciLin R and SciLin M30 (alone or in combination) in routine clinical practice.
16174574|NCT01588639|Drug|Insulin (Scilin R _BAY81-9924|Subjects are treated with recombinant human insulin-SciLin N, SciLin R and SciLin M30 (alone or in combination) in routine clinical practice
16174575|NCT01588639|Drug|Insulin(Scilin M30_BAY81-9924)|Subjects are treated with recombinant human insulin-SciLin N, SciLin R and SciLin M30 (alone or in combination) in routine clinical practice
16174576|NCT01588626|Drug|AZD6140|tablet
16174577|NCT01588600|Other|Dietary Fiber|Fiber added to breakfast
16174578|NCT01588587|Drug|Sitagliptin|The dosage, frequency and duration for each sitagliptin are variant.
16174579|NCT01588587|Drug|Alogliptin|The dosage, frequency and duration for each alogliptin are variant.
16174580|NCT01588587|Drug|Vildagliptin|The dosage, frequency and duration for each vildagliptin are variant.
16174581|NCT01588574|Biological|MT10109|Botulinum toxin type A
16174582|NCT01588574|Biological|BOTOX(Registered trade mark)|Botulinum toxin type A
16174583|NCT01588561|Drug|Intravenous Nicotine|Subjects received a single infusion of nicotine, 1.5 mg/70kg (New England Compounding Center, Framingham, MA), administered over 1 minute into the antecubital vein 10 minutes into their MRI scans.
16174584|NCT01588561|Other|Saline - placebo|Subjects received a single infusion of saline, administered over 1 minute into the antecubital vein 10 minutes into their MRI scans.
16174585|NCT01588548|Drug|AZD1208|Dose of AZD1208 will be escalated from 120mg to a maximum tolerated dose
16174586|NCT01588535|Drug|benzocaine|benzocaine 10 mg/mL, five drops in affected ear canal each hour as needed
16174587|NCT01588535|Drug|placebo|placebo solution, five drops in affected ear canal each hour as needed
16174588|NCT01588522|Drug|compound 31543 Calcitriol|topical compound 31543 will be applied to the scalp twice daily 7 +/- 2 days prior to the dose of chemotherapy and continue the application twice daily for 3 months or until termination of chemotherapy treatment.
16174589|NCT01588509|Drug|Romosozumab|Administered by subcutaneous injection
16174590|NCT01588496|Biological|Evolocumab|Administered by subcutaneous injection
16174591|NCT01588496|Drug|Placebo|Administered by subcutaneous injection
16174592|NCT01588470|Drug|pioglitazone|45 mg per day for 6 months
16174593|NCT01588457|Drug|Lithium|Therapeutic dosage as indicated by participants condition with blood levels. LI will be dosed to attain Li of ≥0.5mEq/L (milliequivalents per liter).
16174594|NCT01588457|Drug|Divalproex|DV will be dosed to attain DV levels of ≥45mg/L.
16174595|NCT01588457|Drug|Lamotrigine|LM will be incrementally dosed up to 400 mg/day, or, in combination with DV, 200 mg/day. Dosage may be reduced for adverse effects to one half of the target dose.
16174596|NCT01588457|Drug|Quetiapine|QT will be started at 50 mg/day and titrated up to 300 mg as tolerated. QT will be discontinued if not tolerated at 100mg/day and the patient will be treated according to guidelines.
16174597|NCT01588444|Device|cortical FDBA|cortical mineralized freeze-dried bone allograft
16174598|NCT01588444|Device|Cancellous FDBA|CANCELLOUS FREEZE-DRIED BONE ALLOGRAFT (from LifeNet Health)
16174599|NCT01588431|Drug|Docetaxel, Cisplatin, Cetuximab and Bevacizumab (TPE-A) Followed by Concurrent Radiation, Cisplatin, Cetuximab and Bevacizumab (XPE-A), surgery|Induction therapy consists of 3 cycles of bevacizumab 15mg/kg on day 1, cetuximab weekly days 1,8,15 (loading dose of cetuximab 400mg/m2 on cycle 1, day 1, then 250 mg/m2 on all subsequent administrations), cisplatin 75mg/m2 on day 1, docetaxel 75mg/m2 on day 1, repeated every 21 days. After 3 cycles of induction therapy, patients will receive standard radiation 70-74 Gy/ 200 cGy/ daily, 5 days/ week with concurrent weekly cisplatin 30mg/m2, cetuximab 250mg/m2 and bevacizumab 15mg/kg every 3 weeks x 3. There is optional surgery for non-responders in the primary (stable disease) after TPE-A.
16174600|NCT01588418|Drug|Exenatide|Exenatide (5mcg) was administered in random order 30 min before OGTT-PET study, crossover study
16174601|NCT01588418|Drug|Placebo|Placebo was administered in random order 30 min before OGTT-PET study in the same subject
16174602|NCT01588405|Drug|UT-15C SR|Subjects will transition in the hospital from Remodulin to UT-15C SR within 5 days of the start of the transition. The dose of Remodulin will be decreased as the dose of UT-15C SR is increased over the 5 days. Once subjects have been transitioned from Remodulin, the dose of UT-15C SR will continue to be modified / titrated to the appropriate optimal dose for that subject throughout the rest of the study.
16174603|NCT01588392|Behavioral|Short bouts of structured physical activity|Short bouts of structured physical activity preschools will be asked to implement age-appropriate 10 minute structured physical activity routines within the classroom setting followed by 20 minutes of usual unstructured playtime activities. Intervention will be implemented for a total of 30 minutes during both morning and afternoon gross motor playtime 5 days/week for 6 months.
16174604|NCT01588392|Behavioral|Unstructured physical activity|Unstructured physical activity intervention will consist of 30 minutes of supervised unstructured free playtime twice. intervention will be delivered during both morning and afternoon gross motor playtime for 5 days/week for 6 months.
16174605|NCT01588379|Behavioral|Girls and mothers Afro-centric dance program|African-American girls and their mom's will participate in an after school Afro-centric dance program for 3 days/week for 12 weeks. Both girls and the mothers will also receive weekly newsletter containing various health information.
16174606|NCT01588379|Behavioral|Girls, alone|African-American girls (without their mom's) will participate in an after school Afro-centric dance program for 3 days/week for 12 weeks. Both girls and the mothers will also receive weekly newsletter containing various health information.
16174607|NCT01588379|Other|Newsletter|Both girls and the mothers will receive weekly newsletter containing various health information.
16174608|NCT01588366|Drug|Placebo|Administered orally
16174609|NCT01588366|Drug|LY2409021|Administered orally
16174610|NCT01588353|Drug|Collagenase Clostridium Histolyticum|AK160 (Collagenase Clostridium Histolyticum) 0.58 mg
16174611|NCT01588340|Procedure|MRI (Magnetic resonance imaging)|Subject will complete a 15 minute scan in the MRI
16174612|NCT01588340|Procedure|Ultrasound exam|The subject will complete a noncontrast ultrasound procedure that will take approximately 25 minutes to complete
16174613|NCT01588314|Drug|Gabapentin|gabapentin 100 mg capsules
16174614|NCT01588314|Drug|placebo|compounded placebo capsules
16174615|NCT01588301|Behavioral|Attending for cervical cytology|A further invitation to attend for cervical cytology are going to be sent by mail to women
16174616|NCT01588301|Behavioral|Kit for Self-collected vaginal sample|Kit for self-collected vaginal sample are going to be directly sent at women's home
16174617|NCT01588288|Procedure|Galectin 3 dosage|Preoperative Galectin 3 dosage in plasma and water rinse of the needle aspiration biopsy.
16174618|NCT01588275|Device|mandibular repositioning appliance (MRA) (SomnoDent)|bibloc MRA type SomnoDent starting at 70% protrusion of the mandibula
16174619|NCT01588275|Procedure|Continuous positive airway pressure (CPAP)|Proper CPAP-pressure will be set for each patient separately.
16174620|NCT01588262|Other|Stressmanagement|Individual stepped-care approach stressmanagement by specially trained counsellor
16174621|NCT01588249|Dietary Supplement|Pasteurized maple syrup|
16174622|NCT01588249|Dietary Supplement|Placebo|
16174623|NCT01588236|Drug|high dose KYG0395|3 KYG0395 capsules tid (morning, midday, and evening)
16174624|NCT01588236|Drug|lower dose KYG0395|3 KYG0395 capsules 2 times a day (bid) (morning and evening) plus 3 capsules of placebo (midday)
16174625|NCT01588236|Drug|Placebo|3 capsules of placebo tid (morning, midday, and evening)
16174626|NCT01588223|Other|Lipid identification|The lipids are identified using Mass Spectrometry
16174627|NCT01588210|Other|Sealant application|"A high-viscosity glass-ionomer cement (KETAC™ MOLAR APLICAP 3M Espe, Germany) will be used.
~All sealants was applied following these steps: tooth isolation using cotton rolls or rubber dam; tooth cleaning using a rotary brush mounted on a low-speed contrangle with a prophylaxis pasta without fluoride; enamel etching using 37% phosphoric acid (H3PO4) for 30 seconds; rinse thoroughly with water and dry; placement a thin layer of sealant material and cure according to manufacturer's instructions and finally occlusion adjustment, if necessary."
16174628|NCT01588210|Other|sealant application|"A white photopolymerizable Resin-Based sealant containing fluoride (Helioseal F®, Ivoclar Vivadent AG, Fürstentum Liechtenstein) will be used.
~All sealants was applied following these steps: tooth isolation using cotton rolls or rubber dam (it was mandatory for both the RB sealants); tooth cleaning using a rotary brush mounted on a low-speed contrangle with a prophylaxis pasta without fluoride; enamel etching using 37% phosphoric acid (H3PO4) for 30 seconds; rinse thoroughly with water and dry; placement a thin layer of sealant material and cure according to manufacturer's instructions and finally occlusion adjustment, if necessary."
16174629|NCT01588210|Other|sealant application|"A white photopolymerizable Resin-Based sealant (Concise 1930TM 3M Espe, Germany) will be used.
~All sealants was applied following these steps: tooth isolation using cotton rolls or rubber dam (it was mandatory for both the RB sealants); tooth cleaning using a rotary brush mounted on a low-speed contrangle with a prophylaxis pasta without fluoride; enamel etching using 37% phosphoric acid (H3PO4) for 30 seconds; rinse thoroughly with water and dry; placement a thin layer of sealant material and cure according to manufacturer's instructions and finally occlusion adjustment, if necessary."
16174630|NCT01588197|Behavioral|Attention/Distraction Strategy|One of three Cognitive Pain Inhibition Strategies. The Participant will be instructed to attend away from the thermal stimulus (for example, to the other side of the body). Vividly imagine they are somewhere else, or engage in a high-demanding mental task such as counting backward by 7's or completing math problems to distract from the experience
16174631|NCT01588197|Behavioral|Stimulus Quality/Severity Strategy|One of three Cognitive Pain Inhibition Strategies. The Participant will be instructed to attempt to perceive the stimulus as a neutral sensory experience rather than pain. Attempt to perceive the stimulus as low intensity rather than high intensity.
16174632|NCT01588197|Behavioral|Control Strategy|One of three Cognitive Pain Inhibition Strategies. The Participant will be instructed to attempt to take control of their perception of the painful experience.
16174633|NCT01588184|Drug|Bevacizumab|Bevacizumab will be administered at 7.5 or 15 milligrams per kilogram (mg/kg) intravenously every 3 weeks (Q3W), or 5 or 10 mg/kg intravenously every 2 weeks (Q2W).
16174634|NCT01588171|Drug|Bemiparin|Bemiparin sodium 3,500 IU anti Xa/0.3 ml solution for injection in pre-filled syringe will be provided for each patient in Bemiparin group; subcutaneously 6 hours after delivery(vaginal and Caesarean)and then daily for up to 7 days.
16174635|NCT01588171|Drug|Enoxaparin|Enoxaparin sodium 40mg (equivalent to 4,000 IU anti-Xa activity) in 0.4ml water for injection will be administered subcutaneously 6 hours after the delivery( vaginal or abdominal)then daily up to 7 days post partum, for Enoxaparin group of patients.
16174636|NCT01588158|Drug|Acetaminophen|325 mg
16174637|NCT01588158|Drug|Vicodin|Vicodin 5/325 mg
16174638|NCT01588145|Drug|HM61713|BID or QD, PO X 21 day cycle Number of cycles: until progression or unacceptable toxicity develops
16174720|NCT01587391|Drug|BI 163538 XX|1 single dose per subject as oral solution
16175126|NCT01584154|Procedure|radiofrequency ablation|radiofrequency ablation with a 4mm-tip catheter
16174639|NCT01588132|Drug|Anfibatide|"To investigate the safety and tolerability of single intravenous dose of Antiplatelet Thrombolysin for Injection of 0.33,0.66,1.0,1.5,2.0,3.0,4.0,5.0μg (body weight 60kg) in healthy volunteers.
~To investigate the safety and tolerability of continuous administration of three dose regimen: ① give intravenous injection of 3μg as the first dose and after 1.5 hours, infusion of the study product 0.12μg/h for 24 hours. ② give intravenous injection of 3μg as the first dose and immediately infusion of the study product 0.12μg/h for 24 hours. ③ give intravenous injection of 5μg as the first dose and immediately infusion of the study product 0.12μg/h for 24 hours."
16174640|NCT01588093|Drug|Increlex|Increlex 120 micrograms/kg body weight single subcutaneous injection
16174641|NCT01588093|Drug|0.9% Saline|Placebo (0,1 ml of 0.9% Saline) single subcutaneous injection
16174642|NCT01588080|Device|Neurally Adjusted Ventilatory Assist (NAVA)|Neurally adjusted ventilatory assist (NAVA), an adjunct that can only be used with the Servo-i ventilator, allows the patient to synchronize spontaneous respiratory effort with mechanical ventilation. NAVA uses the electromyographic signal of the diaphragm (Edi) to transmit this electrical activity back to the ventilator. The NAVA catheter is a functional gastric tube that has electrodes embedded within it and positioned at the level of diaphragm using an electrocardiogram signal. These electrodes continuously (every 5ms) detect the amplitude, duration, and frequency of the Edi and provide pressure support in proportion to this electrical activity. Proportionality is controlled by a NAVA factor (cmH20/microvolt) and is adjusted by the user.
16174643|NCT01588080|Device|SiPAP - placebo|The Infant Flow® SiPAP provides noninvasive support to neonates. CPAP and Biphasic modes are provided by the Infant Flow® SiPAP. CPAP is an elevated pressure (above atmospheric) and is used to increase a premature babies functional residual capacity (FRC). CPAP is a modality used for babies with both central apneas and mild/moderate increase work of breathing. CPAP increases the FRC and ultimately recruits collapsed alveoli and improves gas exchange in the lungs. BiPhasic, on the other hand, is a modality used for babies that require more respiratory support than CPAP can provide. In BiPhasic mode, respiratory rate (RR), inspiratory time (Ti), and peak inspiratory pressures (PIP) are set and not synchronized with the patients breathing efforts.
16174644|NCT01588015|Biological|tetanus-CMV fusion peptide vaccine|Given SC
16174645|NCT01588015|Other|laboratory biomarker analysis|Correlative studies
16174646|NCT01588002|Drug|danoprevir|multiple oral doses
16174647|NCT01588002|Drug|efavirenz|multiple oral doses
16174648|NCT01588002|Drug|ritonavir|multiple oral doses
16174649|NCT01587989|Drug|methotrexate|15-25 mg orally weekly, Weeks 1-12
16174650|NCT01587989|Drug|methotrexate|15-25 mg orally weekly, Weeks 13-24
16174651|NCT01587989|Drug|placebo|methotrexate placebo orally weekly, Weeks 13-24
16174652|NCT01587989|Drug|tocilizumab [RoActemra/Actemra]|8 mg/kg iv every 4 weeks, 24 weeks
16174653|NCT01587963|Drug|Ascorbic Acid|66mg/kg/hour of peripheral intravenous Vitamin C infusion for 24 hour duration, maximum total of 200 grams
16174654|NCT01587963|Other|Ringers Lactate or Normal Saline|Fluid resuscitation will be given with NS or LR to achieve a same mean urine output of 0.5cc/kg/hour.
16174655|NCT01587950|Drug|Potassium Nitrate|250 μL of Potassium nitrate solution (either 5% or 2.5%)
16174656|NCT01587950|Drug|Placebo|Sterile Water
16174657|NCT01587937|Other|Antibiotic stewardship audit-and-feedback to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antibiotics|See primary outcome for list of targeted drugs. See citations for previous publications describing the intervention.
16174658|NCT01587924|Drug|GSK1278863|tablet
16174659|NCT01587924|Drug|rhEPO|injection
16174660|NCT01587911|Other|Whey|Preload containing complete whey protein.
16174661|NCT01587911|Other|Whey-CMP|Preload containing complete whey protein which is missing the CMP/GMP portion of the protein.
16174662|NCT01587911|Other|Control|Preload control matched for energy to the other 5 preloads.
16174663|NCT01587911|Other|CMP|Preload containing the CMP (casinomacropeptide) portion cleaved from complete whey protein.
16174664|NCT01587911|Other|MPI|Preload containing whole milk protein.
16174665|NCT01587911|Other|CPI|Preload containing sodium caseinate.
16174666|NCT01587898|Drug|GSK1278863|Tablet
16174667|NCT01587898|Other|Placebo|Tablet
16174668|NCT01587885|Drug|Omeprazole 20 mg + Sodium Bicarbonate 1100 mg|Capsules, orally
16174669|NCT01587885|Drug|Omeprazole 20 mg|Tablets, orally
16174670|NCT01587872|Procedure|Fujinon EC-450BI5 double-balloon colonoscope|Colonoscopy with the test instrument
16174671|NCT01587859|Procedure|laparoscopic surgery|Nissen fundoplication; Collis Gastroplasty.
16174672|NCT01587846|Dietary Supplement|Administration of L.reuteri in children with abdominal pain|Group of around 75 children which will receive L. reuteri at a dose 100.000.000 CFU per dose for 3 months. The active study product consists of a citrus flavored 450 mg chewable tablet containing freeze-dried L. reuteri DSM 17938. The study product is a convex tablet 10.3 mm in diameter, plain on both sides and with faint spots. It is composed of freeze-dried L. reuteri, isomalt, xylitol, sucrose distearate, hydrogenated palm oil, lemon-lime flavoring and anhydrous citric acid. The total viable count of L. reuteri is 1x100.000.000 live bacteria (CFU)/tablet.
16174673|NCT01587846|Dietary Supplement|Administration of placebo in children with abdominal pain|Group of around 75 children which will receive placebo for 3 months. The placebo consists of a citrus flavored 450 mg chewable convex tablet 10.3 mm in diameter, plain on both sides and with faint spots. It is composed of isomalt, xylitol, sucrose distearate, hydrogenated palm oil, lemon-lime flavoring and anhydrous citric acid.
16174674|NCT01587846|Dietary Supplement|Administration of L.reuteri in children with constipation|Group of around 75 children which will receive L. reuteri at a dose 100.000.000 CFU per dose plus lactulose in a dose 1-3 ml/kg, according to the stool frequency and consistency, for 3 months. The active study product consists of a citrus flavored 450 mg chewable tablet containing freeze-dried L. reuteri DSM 17938. The study product is a convex tablet 10.3 mm in diameter, plain on both sides and with faint spots. It is composed of freeze-dried L. reuteri, isomalt, xylitol, sucrose distearate, hydrogenated palm oil, lemon-lime flavoring and anhydrous citric acid. The total viable count of L. reuteri is 1x100.000.000 live bacteria (CFU)/tablet.
16174721|NCT01587378|Drug|Metformin|Metformin 500 mg tablets, 1 tablet x 2 daily the first week and then 2 tablets x 2 daily from the second week to delivery
16174855|NCT01586390|Other|Functional treatment for ankle sprain using ankle cast|Functional treatment for ankle sprain using ankle cast
16174675|NCT01587846|Dietary Supplement|Administration of placebo in children with constipation|Group of around 75 children which will receive placebo plus lactulose in a dose 1-3 ml/kg, according to the stool frequency and consistency, for 3 months. The placebo study product consists of a citrus flavored 450 mg chewable convex tablet 10.3 mm in diameter, plain on both sides and with faint spots. It is composed of isomalt, xylitol, sucrose distearate, hydrogenated palm oil, lemon-lime flavoring and anhydrous citric acid.
16174676|NCT01587833|Drug|Benzodiazepine (BZD) use, defined by ATC codes|BZD prescription during the study period between January 1, 2001 and December 31, 2009
16174677|NCT01587820|Drug|Intra-arterial cisplatin|150 mg/m2 cisplatin given intra-arterially combined with sodium thiosulfate infusion given on days 1, 8, 15, for a total of 4 cycles, each cycle totaling 7 days and Radiotherapy: Primary tumor and upper neck will be treated with 2 Gy/fraction, once a day, five days a week to a total dose of 70 Gy/35 fractions/7 weeks
16174678|NCT01587820|Drug|Intravenous cisplatin|100 mg/m2 cisplatin given intravenously once every 21 days (3 week cycle) for 3 cycles and Radiotherapy: Primary tumor and upper neck will be treated with 2 Gy/fraction, once a day, five days a week to a total dose of 70 Gy/35 fractions/7 weeks
16174679|NCT01587807|Drug|GSK1995057|inhaled dose (volume based on cohort)
16174680|NCT01587807|Procedure|bronchoalveolar lavage|BAL
16174681|NCT01587807|Drug|LPS|50 μg
16174682|NCT01587807|Drug|Placebo|Sucrose, glycine, sodium dihydrogen phosphate and polysorbate 80 (volume to match active dose)
16174683|NCT01587768|Drug|Antibiotic prescription during the study period between January 1, 2004 and December 31, 2009|Antibiotics will be analysed overall, by class (tetracyclines, penicillins and betalactamics, cephalosporins, macrolides, aminoglycosides, quinolones and other antibiotics (sulphonamides &amp; others combinations)) and individually. The antibiotics administered to patients include: cefuroxime axetil, cefuroxime sodium, ceftazidime sodium, amoxicillin, amoxicillin/ clavulanate, ampicillin, ampicillin/cloxacillin, flucloxacillin, ticarcillin, and ticarcillin/ clavulanate.
16174684|NCT01587755|Other|TTOP|Patient is taken care of in an intensified, optimised manner
16174685|NCT01587755|Other|non-TTOP|Standard medical care
16174686|NCT01587742|Drug|CCB use|Prescription of CCB during the study period between January 1, 1996 to December 31, 2009. The CCBs administered to the patients include isradipine and lacidipine.
16174687|NCT01587729|Drug|Tricyclic AD (TCAs) and selective serotonin re-uptake inhibitors (SSRIs) antidepressants|TCA or SSRI prescription during the study period between January 1, 2001 and December 31, 2009. The TCAs and SSRIs administered to the patients include paroxetine and escitaloprim.
16174688|NCT01587716|Drug|GSK2339345 (Inhaled) Single Dose|250, 1000 and 2000 microgram (proposed doses)
16174689|NCT01587716|Other|Placebo (Inhaled) Single Dose|Inhaled 0.9% sodium chloride solution
16174690|NCT01587716|Drug|GSK2339345 (Inhaled) Repeat Dose|2000 microgram (proposed dose) administered 4 times a day for two consecutive days
16174691|NCT01587716|Other|Placebo (Inhaled) Repeat Dose|Inhaled 0.9% sodium cholride solution
16174692|NCT01587703|Drug|GSK525762|Begin at Dose Level 1 and increase up to 2 fold
16174693|NCT01587664|Device|NewBreez ILP|NewBreez ILP implantation
16174694|NCT01587651|Drug|Prasugrel Loading Dose|60mg given as six 10mg film coated tablets
16174695|NCT01587651|Drug|Prasugrel Maintenance Dose|10mg maintenance dose, given as one 10mg film coated tablet
16174696|NCT01587651|Drug|Ticagrelor Maintenance Dose|one 90mg film coated tablet
16174697|NCT01587638|Drug|carvedilol|carvedilol immediate-release (IR) and carvedilol controlled-release (CR)
16174698|NCT01587638|Drug|cardio selective betablocker|atenolol, metoprolol succinate, and metoprolol tartrate
16174699|NCT01587625|Drug|Oxytocin|
16174700|NCT01587599|Behavioral|counseling|The patients grouped to the intervention cohort receive pharmaceutical care by a pharmacist during the study period.
16174701|NCT01587586|Biological|PEGASYS 180 µg Q1W|48 doses, solution, 48 weeks
16174702|NCT01587586|Biological|P1101 180 µg Q1W, 48 doses|48 doses, solution, 48 weeks
16174703|NCT01587586|Biological|P1101 270µg Q1W, 48 doses|48 doses, solution, 48 weeks
16174704|NCT01587586|Biological|P1101 450µg Q2W, 24 doses|24 doses, solution, 48 weeks
16174705|NCT01587573|Other|saliva collection prior to clinically driven oral biopsy|cell free saliva to be used to measure mRNA and proteins by PCR and ELISA
16174706|NCT01587560|Device|PyroTITAN, Ascension Orthopedics, Inc.|All patients will be operated on with a shoulder resurfacing implant. In one arm of the study, the patients will receive an implant made of pyrocarbon. In the second arm, the patients will receive an implant made of Cobalt-Chrome. Aside from the materials, the implant are of the same design.
16174707|NCT01587560|Device|TITAN, Ascension Orthopedics, Inc.|
16174708|NCT01587534|Drug|Norzyme|Patients will be randomized to receive either pancreatic enzyme replacement therapy or placebo. Patients will use two capsules three times daily during main meals and one capsule three times daily during in between snacks. The pancreatic enzyme preparation under investigation is Norzyme ® 6 - 9 tablets per day.
16174709|NCT01587508|Drug|meloxicam/cyclobenzaprine hydrochloride|two oral capsules a day during approximately 07 days
16174710|NCT01587508|Drug|meloxicam - Movatec®|two oral tablet a day during approximately 07 days
16174711|NCT01587508|Drug|cyclobenzaprine - Miosan®|two oral tablet a day during approximately 07 days
16174712|NCT01587495|Drug|Ertapenem|Ertapenem will be administered by intravenous infusion per the FDA approved standard of care (1 gram q24 hours). as follows:
16174713|NCT01587482|Procedure|PacLitaxel Eluting Balloon Application|Stenting is a standard of care in revascularization for superficial femoral artery (SFA) atherosclerotic lesions. However, the Achilles' heel of this technique remains in-stent restenosis (ISR). While most of local therapies have failed to demonstrate significant benefit, studies for the treatment of SFA ISR are lacking and percutaneous transluminal angioplasty remains the current standard of care for this indication. Recent studies have shown successful results of drug eluting balloon in the treatment of SFA de-novo lesions and of coronary ISR.
16174714|NCT01587430|Drug|high dose ARA-C|high dose ARA-C consolidation together with high cumulative dose of anthracyclines daunorubicin, idarubicin, mitoxantrone(720-660 mg/m2)
16174715|NCT01587430|Drug|standard dose ARA-C|
16174716|NCT01587417|Drug|Placebo to BI 187004 CL|1 single dose per subject as oral solution
16174717|NCT01587417|Drug|BI 187004 CL|1 single dose per subject as oral solution
16174722|NCT01587378|Drug|placebo|identical placebo tablets, 1 tablet x 2 daily the first week and then 2 tablets x 2 daily from the second week to delivery
16174723|NCT01587365|Biological|BMS-962476|
16174724|NCT01587365|Biological|Placebo matching with BMS-962476|
16174725|NCT01587352|Other|Laboratory Biomarker Analysis|Correlative studies
16174726|NCT01587352|Drug|Vorinostat|Given PO
16174727|NCT01587339|Drug|retigabine/ezogabine|oral - all doses
16174728|NCT01587339|Drug|lacosamide|oral - all doses
16174729|NCT01587339|Drug|zonisamide|oral - all doses
16174730|NCT01587339|Drug|pregabalin|oral - all doses
16174731|NCT01587339|Drug|eslicarbazepine|oral - all doses
16174732|NCT01587326|Drug|Escitalopram|escitalopram 10 mg/d to 20 mg/d
16174733|NCT01587313|Drug|Isosorbide dinitrate / hydralazine capsules|Group 1: Day 1:Two SR capsules; Day 8: One IR capsule Group 2: Day 1:Two SR capsules; Day 8: One IR capsule Group 3: Day 1:Two SR capsules; Day 8: One IR capsule Group 4: Day 1:One IR capsule and two SR capsules; Day 8: Commercial BiDil Tablet tid
16174734|NCT01587287|Device|Corneal power measurement|All subjects will be underwent a full ophthalmic examination including vision, auto- and subjective refraction, slit-lamp examination, non-contact tonometry, corneal power measurements with the 8 devices and fundus examination.
16174735|NCT01587274|Drug|Naproxen|Naproxen 500mg twice/ day x 10 days
16174736|NCT01587274|Drug|Cyclobenzaprine|Cyclobenzaprine 5-10mg three times/ day x 10 days
16174737|NCT01587274|Drug|Oxycodone/ acetaminophen|Oxycodone 5-10mg/ Acetaminophen 325-650 mg three times/ day x 10 days
16174738|NCT01587261|Drug|Vitamin C|Treatment Group will receive a dose of 66 mg/kg/hr of ascorbic acid injection for 24 hours after injury
16174739|NCT01587261|Drug|Placebo|Lactated Ringers solution will be given at a similar volume to what the treatment group will receive
16174740|NCT01587248|Device|Harmonic|Dissection with harmonic scalpel
16174741|NCT01587248|Procedure|electrocautery|Dissection in modified radical mastectomy
16174742|NCT01587235|Drug|Ezetimibe/simvastatin|Algorithm based treatment using 10/10mg, 10/20mg and 10/40mg ezetimibe/simvastatin combination tablets orally once daily.
16174743|NCT01587235|Drug|Other Statin|Participants are prescribed a statin (any other than Vytorin) as per routine standard of care
16174744|NCT01587222|Drug|Albumin|Albumin (20%) 1g/kg iv on day 1 and 80 g every 2 weeks during a period of 12 weeks.
16174745|NCT01587222|Drug|Midodrine|"Oral midodrine 5 mg / 8 hours for 12 weeks. The dose may be increased on day 7 10mg/8h.
~If creatinine does not decrease ≥ 25% and systolic blood pressure is bellow 150 mmHg and diastolic 90 mmHg doses will be changed."
16174746|NCT01587222|Drug|Octreotide|"Octreotide by subcutaneous injection 0.1 mg every 8 hours for 12 weeks. The dose may be increased to 0.2 mg / 8 h on day 7.
~If creatinine does not decrease ≥ 25% and systolic blood pressure is bellow 150 mmHg and diastolic 90 mmHg doses will be changed."
16174747|NCT01587196|Drug|Vivitrol|There are monthly injections of depot naltrexone for 3 months.
16174748|NCT01587183|Behavioral|Educational material control|Participants will be given educational materials on starting a running program using a run/walk approach.
16174749|NCT01587183|Behavioral|Group running style B|Participants will attend a 4 hour group based training and 3, 2 hour follow up trainings.
16174750|NCT01587183|Behavioral|Group running style A|Participants will attend a 4 hour group based training and 3, 2 hour follow up trainings.
16174751|NCT01587157|Procedure|capnography|
16174756|NCT01587131|Biological|FVH1 - a DNA-based influenza vaccine|0.9 mg FVH1 vaccine
16174757|NCT01587118|Drug|Adjunctive asenapine|participants who are not responding fully to antidepressant therapy for PTSD will receive adjunctive asenapine (flexible dosing beginning with 5 mg sublingual once per day, titrated up to 10 mg twice per day, as tolerated) for a total of 12 weeks.
16174758|NCT01587105|Behavioral|Comprehensive Case Management Service|When a child enrolls in the CCM program, the child's parent will work together with the CCM team at Seattle Children's to develop a shared care plan for their child. This plan will include all of the child's routine health care needs and information about what to do when the child gets sick. The parent will also have 24 hour access to an on-call CCM nurse.
16174759|NCT01587092|Behavioral|WorkStation|Participants will be asked to attend 2 scheduled sessions per day of treadmill walking, which will replace their sitting desk time. Participants will complete 2 sessions per day for 6 months.
16174760|NCT01587092|Behavioral|Usual Working Condition|Participants will be asked to continue working at their desk in their usual manner.
16174761|NCT01587079|Drug|PT003|PT003 MDI administered as two puffs BID for 7 days
16174762|NCT01587079|Drug|PT001|PT001 MDI administered as two puffs BID for 7 days
16174763|NCT01587079|Drug|PT005|PT005 MDI administered as two puffs BID for 7 days
16174764|NCT01587079|Drug|Tiotropium inhalation powder|Taken as 1 capsule containing 18 µg of Tiotropium via the Handihaler DPI for 7 days
16174765|NCT01587066|Drug|Quetiapine fumarate|Efficacy of Quetiapine XR vs. Divalproex on Clinical Outcome, Quality of Sleep and Quality of Life in Bipolar Depression
16174901|NCT01585987|Other|Best Supportive care (BSC)|
16174766|NCT01587066|Drug|Divalproex sodium|Efficacy of Quetiapine XR vs. Divalproex on Clinical Outcome, Quality of Sleep and Quality of Life in Bipolar Depression
16174767|NCT01587053|Other|therapeutic education program|
16174768|NCT01587040|Drug|SAR245408|Pharmaceutical form: capsule or tablet Route of administration: oral
16174769|NCT01587040|Drug|SAR245409|Pharmaceutical form: capsule or tablet Route of administration: oral
16174770|NCT01587027|Drug|Aminophylline|Aminophylline dosage form-tablet dosage-500mg
16174771|NCT01587027|Drug|Methazolamide|Methazolamide dosage form-tablet dosage-250mg
16174772|NCT01587027|Drug|Aminophylline and Methazolamide|Aminophylline 500mg orally and Methazolamide 250mg orally
16174773|NCT01587001|Dietary Supplement|N-acetyl-cysteine|900mg three times daily for 8 weeks
16174774|NCT01587001|Drug|Placebo|Matching placebo three times daily for 8 weeks.
16174775|NCT01586988|Behavioral|IMAGE Intervention|Mothers in the intervention will receive four individual intervention sessions with a facilitator. The sessions will cover parenting and self care skills.
16174776|NCT01586975|Drug|Clopidogrel|Clopidogrel 75 mg QD
16174777|NCT01586975|Drug|Aspirin 81 mg|Aspirin 81mg QD
16174778|NCT01586975|Drug|Aspirin >300 mg|Aspirin >300 mg QD
16174779|NCT01586962|Drug|IFF flavor 316 282, Paracetamol, Pseudoephedrine|Single dose syrup containing a warmingflavor IFF 316282 in a syrup containing Paracetamol and pseudoephedrine
16174780|NCT01586949|Behavioral|Daily Challenge|Web-based behavioral intervention aiming to improve individuals' well-being.
16174781|NCT01586936|Drug|eptacog alfa (activated)|Prescription of eptacog alpha at the discretion of the physician
16174782|NCT01586923|Biological|RBC transfusion|RBC transfusion of different storage age
16174783|NCT01586910|Device|Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)|
16174784|NCT01586910|Procedure|Surgical Aortic Valve Replacement (SAVR)|
16174785|NCT01586910|Device|Medtronic CoreValve® Evolut R System Transcatheter Aortic Valve Implantation (TAVI)|
16174786|NCT01586897|Device|Medication Metronome|Providers allocated to intervention will see an additional feature when logging on to their electronic health record medication prescription interface that enables them to schedule future laboratory testing for the pre-defined subset of study-specific medications. New prescription or dose adjustment by the PCP of one of these pre-specified medications used to treat type 2 diabetes, hypertension, or hyperlipidemia will initiate the follow-up result monitoring, patient outreach, and PCP reminders that constitute the Medication Metronome system.
16174787|NCT01586897|Other|Usual Care|
16174788|NCT01586884|Procedure|Pressure/Conductance Catheter|"The physician will obtain right femoral arterial access and advance the pressure/conductance catheter to the LV utilizing the retrograde approach. Baseline dP/dt and stroke volume will be recorded in the patient's presenting rhythm.
~The dP/dt and stroke volume will be measured during biventricular pacing. Hemodynamic measurements will be made with the tip of the pacing lead in the distal vessel, followed by repeat measurements with the lead positioned in the mid and proximal portions of the initially selected vein.
~The pacing and hemodynamic measurements will be repeated with the CS lead positioned in two additional veins (if possible). The pressure/conductance catheter will be removed from the left ventricle after 30 minutes, regardless of the number of pacing sites identified/tested. The physician will make the choice of the LV lead placement based on the information gathered up to that point."
16174789|NCT01586858|Other|Observational|Observational study of subjects previously enrolled in the RAVE trial
16174790|NCT01586845|Drug|voclosporin|Initial dose of voclosporin 0.8 mg/kg BID, then concentration controlled
16174791|NCT01586845|Drug|tacrolimus|tacrolimus as per labeled dose
16174792|NCT01586819|Drug|Botulinum Toxin|"The botulinum toxin will be injected into the wrinkles crow's feet. The injections will take about 10 minutes to complete."
16174793|NCT01586819|Procedure|Chemical Peel Only|After cleansing the face with a pre-treatment cleansed composed of water and alcohol, the Jessner's peel solution [a combination of resorcinol (14g), salicylic acid (14g), and lactic acid (85%) in ethanol (95%)] will be applied to the entire face with a large cotton swab. The mixture will be left in place for a few minutes, and then the face will be wiped clean with water. Next, the TCA peel [35% Trichloroacetic acid] will be applied around the eyes. After leaving in place for a few minutes, cool, iced washcloths will be applied and the face will be wiped clean with water. Wound care regimen will consist of dilute acetic acid and either Aquaphor or petroleum jelly.
16174794|NCT01586806|Drug|Bupivacaine Only|This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).
16174795|NCT01586806|Drug|Bupivacaine with 1 mg of Dexamethasone|This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.
16174796|NCT01586806|Drug|Bupivacaine with 4 mg of Dexamethasone|This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
16174797|NCT01586793|Device|Magstim Rapid2 Stimulator|1 Hz in 1 train of 20-minute duration (1,200 pulses per session) at 120% of the rMT.
16174798|NCT01586793|Device|Magstim Rapid2 Stimulator|10 Hz in 75 trains of 4-seconds duration, with 26-seconds intertrain intervals (3,000 pulses per session) at 120% of the rMT.
16174799|NCT01586780|Dietary Supplement|Protein drink|Test drink providing 9g protein
16174800|NCT01586780|Dietary Supplement|Reference meal|Control meal
16174801|NCT01586767|Radiation|Proton radiation therapy|Daily proton radiation therapy
16174802|NCT01586767|Radiation|Intensity-modulated radiotherapy|Daily intensity-modulated radiotherapy
16174803|NCT01586741|Procedure|Quill suture application for repair or polypropylene mesh|The first arm may be insertion of the-mesh The second arm may double row- suture The third arm may be conservative -training
16174804|NCT01586728|Other|Air - oxygen|"his routine long term treatment without nocturnal oxygen therapy during 6 weeks (air period)
~nocturnal oxygen therapy with a stable flow to obtain a nocturnal SpO2 > 90% (oxygen period) while continuing his routine long term treatment during 6 weeks.
~During the oxygen period, the oxygen flow will be at least 1.5l/min. This flow may be increased up to 2L/min in case of the presence of nocturnal periods with SpO2 <= 90%."
16174805|NCT01586728|Other|Oxygen - Air|"nocturnal oxygen therapy with a stable flow to obtain a nocturnal SpO2 > 90% (oxygen period) while continuing his routine long term treatment during 6 weeks.
~his routine long term treatment without nocturnal oxygen therapy during 6 weeks (air period) During the oxygen period, the oxygen flow will be at least 1.5l/min. This flow may be increased up to 2L/min in case of the presence of nocturnal periods with SpO2 <= 90%."
16174806|NCT01586715|Drug|Adipose-derived stem cells without expanded|Administration will be intralesional injection of cells suspension. They will be placed into fistula walls
16174807|NCT01586702|Behavioral|Patient centered structured support program|"Behavioural: Structured support program
~Program with up to 8 outpatient appointments focusing on:
~Measurement of risk factors
~Assessment of medication intake
~Monitoring of antithrombotic therapy
~Joint agreement of an individual target plan
~Target values for risk factors:
~Blood pressure < 140/85 mmHg (<130/80 in diabetics), normal circadian profile
~HbA1c <7.5%
~Nicotine abstinence
~LDL < 100mg/dl (< 70mg/dl in high risk patients)
~Physical activity ≥ 30min >2 x / week
~Targets for pharmaceutical treatment:
~Platelet inhibitors for strokes / TIA of arterial etiology
~Combined platelet inhibition over 3 months in symptomatic intra- or extracranial stenosis
~Cumarins (INR 2-3) or new oral anticoagulants in AF patients
~Statin treatment in patients with LDL >100mg/dl
~Intervention strategies:
~• According to Motivational Interviewing"
16174808|NCT01586689|Behavioral|Oxford House|community-based recovery home for participants recovering from substance dependency
16174809|NCT01586689|Behavioral|Safe Haven|professionally-staffed treatment facility
16174810|NCT01586689|Behavioral|Usual aftercare|control group - participants may or may not seek treatment on their own
16174811|NCT01586676|Behavioral|SAU|Supervision-as-usual
16174812|NCT01586676|Behavioral|MIA: STEP|Motivational Interviewing Assessment: Supervisory Tools for Enhancing Proficiency (MIA: STEP
16174813|NCT01586663|Device|Serial night time position splint|This group will use a serial night time position splint, adjusted monthly, during three months.
16174814|NCT01586663|Drug|Drug treatment|This patients will keep there drug treatment and will receive their splints on the end of the study.
16174815|NCT01586650|Other|aerobic training|The intervention comprises fifty minutes of walking at anaerobic threshold plus stretching exercises 3 times a week for 12 weeks.
16174816|NCT01586650|Other|Stretching exercises|Global stretching exercises will be performed for about 20 minutes 3 times a week for 12 weeks with supervision of specialized physiotherapists.
16174817|NCT01586637|Other|Art Therapy|This group performed dance classes and regarding the art therapy they have art classes where they learn how to use the drawing to express feelings. The classes were twice a week.
16174818|NCT01586637|Other|Walking|The group walked twice a week during one hour.
16174819|NCT01586624|Drug|Vandetanib, Selumetinib|"Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
~Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 25 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
16174820|NCT01586624|Drug|Vandetanib, Selumetinib|"Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
~Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
16174821|NCT01586624|Drug|Vandetanib, Selumetinib|"Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
~Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 75 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
16174822|NCT01586624|Drug|Vandetanib, Selumetinib|"Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
~Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 100 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
16174823|NCT01586624|Drug|Vandetanib, Selumetinib|"Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 100 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). Cycle 1 is 42 days long.
~Cycle 2 onwards: Vandetanib steady state dose of 100 mg OD + 125 mg of selumetinib OD (28 days). From Cycle 2, cycles are 28 days long.
~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
16174824|NCT01586624|Drug|Vandetanib, Selumetinib|"Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
~Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
16174825|NCT01586624|Drug|Vandetanib, Selumetinib|"Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 2) followed by vandetanib steady state dose of 300 mg OD (Days 3 to 14) followed by vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
~Cycle 2 onwards: Vandetanib steady state dose of 300 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
16174826|NCT01586624|Drug|Vandetanib, Selumetinib|"Cycle 1: Vandetanib higher (lead in) dose of 300 mg OD (Days 1 to 4) followed by vandetanib steady state dose of 200 mg OD (Days 5 to 14) followed by vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). Cycle 1 is 42 days long.
~Cycle 2 onwards: Vandetanib steady state dose of 200 mg OD + 50 mg of selumetinib BD (28 days). From Cycle 2, cycles are 28 days long.
~Patients will be allowed to receive 6 cycles. If the patient is still benefiting clinically with no unacceptable toxicity, then the Investigator can ask the Sponsor for continuation of treatment."
16174827|NCT01586611|Drug|5FU, leucovorin, oxaliplatin|Oxaliplatin 100 mg/m2 IV day 1 Leucovorin 400 mg/m2 IV day 1 5-FUl 400 mg/m2 IV day 1 5-FU 2400 mg/m2 IV continuous infusion over 46 hours starting day 1
16174828|NCT01586611|Drug|Gemcitabine|1000 mg/m2 IV weekly for 3 weeks then one week off
16174829|NCT01586598|Behavioral|sensory retraining protocol|"within one month after the surgery: facial massage and physical stimulation over lower face and lip, four times (20 minutes each time) a day
~one to three months after the surgery: brush and physical stimulation over lower face and lip, four times (20 minutes each time) a day
~three to six months after the surgery: brush, pin and physical stimulation over lower face and lip, four times (20 minutes each time) a day"
16174830|NCT01586572|Drug|mOPV1|Monovalent type 1 oral poliovirus vaccine (mOPV1) containing at least106 TCID50 of Sabin- strain poliovirus type 1.
16174831|NCT01586572|Drug|bOPV 1,3|The bivalent vaccine containing at least 106 CCID50 of Sabin poliovirus type 1 and 105•8 CCID50 of Sabin poliovirus type 3.
16174832|NCT01586546|Behavioral|Face-to-Face MBM Skills Group|Mind Body Medicine (MBM) Skills Groups provide a means for study participants to learn skills for taking care of themselves in a supportive small group setting. Participants will learn and practice a variety of specific MBM skills. These MBM skills will enable a participant to change the way she/he deals with the wide range of stressors at different stages of her/his cancer journey. Some of these MBM skills are meditation, guided imagery, biofeedback, writing, and drawing. These groups are designed to assist a participant in coming to know themselves better and in learning and using these tools that will help the participant to deal with the distress as only a small percentage of cancer patients in distress receive appropriate support.
16174833|NCT01586546|Other|Waitlist Control I|No intervention offered during study period. Intervention is offered after completion of study.
16174834|NCT01586546|Other|Waitlist Control II|No intervention offered during study period. Intervention is offered after completion of study.
16174835|NCT01586546|Behavioral|Online MBM Skills Group|Mind Body Medicine (MBM) Skills Groups provide a means for study participants to learn skills for taking care of themselves in a supportive small group setting. Participants will learn and practice a variety of specific MBM skills. These MBM skills will enable a participant to change the way she/he deals with the wide range of stressors at different stages of her/his cancer journey. Some of these MBM skills are meditation, guided imagery, biofeedback, writing, and drawing. These groups are designed to assist a participant in coming to know themselves better and in learning and using these tools that will help the participant to deal with the distress as only a small percentage of cancer patients in distress receive appropriate support.
16174836|NCT01586533|Drug|Zoenasa-1:4|Zoenasa Rectal Gel (4.0g mesalamine [5-ASA], 1.0g N-acetylcysteine [NAC]; 60ml)
16174837|NCT01586533|Drug|Mesalamine Enema|Mesalamine Rectal Suspension Enema (4.0g mesalamine [5-ASA], 60ml)
16174838|NCT01586507|Drug|ULTRAM ER|One dose of ULTRAM ER that is closest to 2 mg/kg, based on the participant's body weight and adjusting the dose in 25 mg increments.
16174839|NCT01586507|Drug|ULTRAM ER|The target dose for Group 2 will be the one that achieves a level of exposure similar to that seen with a single 200 mg ULTRAM ER dose in adults.
16174840|NCT01586494|Drug|ULTRAM ER|One dose of ULTRAM ER that is closest to 2 mg/kg, based on the participant's body weight and adjusting the dose in 25 mg increments.
16174841|NCT01586494|Drug|ULTRAM ER|The target dose for Group 2 will be the one that achieves a level of exposure similar to that seen with a single 200 mg ULTRAM ER dose in adults.
16174842|NCT01586481|Device|SANIDIAB|off-loading shoe
16174843|NCT01586481|Device|BAROUK|old shoe
16174844|NCT01586468|Drug|WF10|0.5 mg/kg B.W.
16174845|NCT01586468|Drug|NaCl Solution|NaCl Solution
16174846|NCT01586455|Drug|Human Placental Derived Stem Cell|Infusions of thawed HPDSC to be given following UCB infusion.
16174847|NCT01586442|Drug|Eplerenone|Eplerenone 25mg once daily titrated to 50 mg once daily for 4 months
16174848|NCT01586442|Drug|Spironolactone|Spironolactone 12,5mg daily titrated to 25mg once daily for 16 weeks
16174849|NCT01586429|Other|Ultrasound guided femoral nerve block catheter analgesia compared with epidural analgesia for patients with knee OA (osteoarthritis)|
16174850|NCT01586416|Behavioral|Behavioral Intervention|Two or three one-hour sessions of an individual behavioral intervention led by a doctoral-level licensed psychologist during the first 12 weeks of chemotherapy. Intervention addresses modifiable behaviors for managing chemotherapy challenges.
16174851|NCT01586403|Biological|Dose 1|Subjects will receive a single infusion of autologous bulk TIL 1383I TCR transduced T cells supported with low dose IL-2. Autologous bulk TIL 1383I TCR transduced T cells means the infusion will consist of a polyclonal mixture of CD4+ and CD8+ T cells expressing the TIL 1383I TCR. cohort 1 will receive 2.5 x 106 TIL 1383I TCR transduced T cells per kg body weight. Subject in cohort 1 will receive 2.5 x 10^6 TIL 1383I TCR transduced T cells per kg body weight.
16174852|NCT01586403|Biological|Dose 2|Subjects will receive a single infusion of autologous bulk TIL 1383I TCR transduced T cells supported with low dose IL-2. Autologous bulk TIL 1383I TCR transduced T cells means the infusion will consist of a polyclonal mixture of CD4+ and CD8+ T cells expressing the TIL 1383I TCR. Subjects in cohort 2 will receive 7.5 x 10^6 TIL 1383I TCR transduced T cells per kg body weight.
16174853|NCT01586403|Biological|Dose 3|Subjects will receive a single infusion of autologous bulk TIL 1383I TCR transduced T cells supported with low dose IL-2. Autologous bulk TIL 1383I TCR transduced T cells means the infusion will consist of a polyclonal mixture of CD4+ and CD8+ T cells expressing the TIL 1383I TCR. Subjects in cohort 3 will receive 2.5 x 10^7 TIL 1383I TCR transduced T cells per kg body weight.
16174854|NCT01586403|Biological|Dose 4|Subjects then receive a single infusion of autologous bulk TIL 1383I TCR transduced T cells supported with low dose IL-2. Autologous bulk TIL 1383I TCR transduced T cells means the infusion will consist of a polyclonal mixture of CD4+ and CD8+ T cells expressing the TIL 1383I TCR. Subjects in cohort 4 will receive 7.5 x 10^7 TIL 1383I TCR transduced T cells per kg body weight.
16174856|NCT01586390|Other|Ankle sprain treated with removable ankle support|Ankle sprain functionally treated with removable and adjustable ankle support
16174857|NCT01586364|Drug|Ospemifene 60Mg Oral Tablet|
16174858|NCT01586351|Device|Patch Augmentation and ACP injection|Patch augmentation and 4mL autologous conditioned plasma application under the footprint following an arthroscopic repair of the rotator cuff.
16174859|NCT01586338|Drug|Hylan G-F 20|Intra-articular injection (pre-filled glass syringe)
16174860|NCT01586325|Drug|JNJ-47910382 30 mg|JNJ-47910382 30 mg (0.6 mL of an oral suspension of 50 mg/mL of JNJ-47910382) administered once daily as monotherapy for 5 days.
16174861|NCT01586325|Drug|JNJ-47910382 90 mg|JNJ-47910382 90 mg (1.8 mL of an oral suspension of 50 mg/mL of JNJ-47910382) administered once daily as monotherapy for 5 days.
16174862|NCT01586325|Drug|JNJ-47910382 200 mg|JNJ-47910382 200 mg (4 mL of an oral suspension of 50 mg/mL of JNJ-47910382) administered once daily as monotherapy for 5 days.
16174863|NCT01586325|Drug|Placebo|Matching Placebo administered once daily as monotherapy for 5 days.
16174864|NCT01586312|Other|Allogenic mesenchymal stromal cells injection|Mesenchymal stem cells prepared from bone marrow of healthy donors and expanded for 3-4 weeks according to our procedure described in PEI Num. 10-134, authorized by the Spanish Medicine Agency
16174865|NCT01586312|Drug|Hyaluronic Acid|Intra-articular injection of 60 mg of hyaluronic acid (Durolane) in a single injection (3 ml)
16174866|NCT01586299|Drug|Ibuprofen|10 mg/kg every 8 hours until 24 hours after resolution of fever
16174867|NCT01586299|Drug|Acetaminophen|15 mg/kg every 6 hours until 24 hours after resolution of fever
16174868|NCT01586286|Drug|Nifedipine|Nifedipine - 0.2% concentration in a lanolin base; administered twice per day for 28 days; as a vaginal ointment applied to vulvar and vaginal area
16174869|NCT01586286|Drug|Placebo Ointment Base|Placebo administered twice per day for 28 days; as a vaginal ointment applied to vulvar and vaginal area
16174870|NCT01586273|Device|MR-HIFU treatment for pain palliation of bone metastases|A treatment session with the Philips Sonalleve MR-HIFU device for bone pain palliation with high-intensity focused ultrasound.
16174871|NCT01586247|Dietary Supplement|Synbiotic|8g/day galacto-oligosaccharide + 10^9 CFU/day B.lactis
16174872|NCT01586247|Dietary Supplement|Placebo|8g/day maltodextrin
16174873|NCT01586247|Dietary Supplement|Prebiotic|8g/day galacto-oligosaccharide
16174874|NCT01586247|Dietary Supplement|Probiotic|10^9 CFU/day B.lactis
16174875|NCT01586234|Procedure|DSAEK with graft shaping and smoothing|"A 5mm incision will be made in the sclera (white portion) of the eye, approximately 1mm from the edge of the cornea
~The tissue on the underside of the cornea (endothelium) will be scraped away
~The graft from the donor cornea (previously smoothed with a laser) will be inserted through the incision and placed against the endothelium of the host cornea."
16174876|NCT01586234|Procedure|Standard DSAEK|"A 5mm incision will be made in the sclera (white portion) of the eye, approximately 1mm from the edge of the cornea
~The tissue on the underside of the cornea (endothelium) will be scraped away
~The graft from the donor cornea will be inserted through the incision and placed against the endothelium of the host cornea."
16174877|NCT01586221|Other|Music & Physical Therapy|Participants will receive combined Music Therapy and Physical Therapy for 6 Weeks. Two times per week for 1 hour.
16174878|NCT01586208|Drug|valproic acid (VPA)|Best dosage at the initial bolus of VPA in patient with satatus epilepticus refractarius (after benzodiazepine + phenytoin treatment)
16174879|NCT01586195|Drug|Vemurafenib|Vemurafenib 960 mg BID
16174880|NCT01586182|Radiation|Stereotactic Body Radiotherapy|Starting dose is 5.5 Gy x 2 boosts in addition to 57.24 Gy to the primary disease
16174881|NCT01586169|Drug|triple co administration at once of the combination of Albendazole + ivermectin + azithromycin|Albendazole 400mg + ivermectin according to the height + azithromycin according to the height at once
16174882|NCT01586156|Drug|Carvedilol|Group 1 will receive 3.125mg carvedilol twice daily for six months.Group 2 will receive carvedilol in a dose escalation scheme.
16174883|NCT01586156|Drug|placebo|Placebo will be taken twice daily for 6 months
16174884|NCT01586143|Drug|paracetamol|This is a clinical study that aims to investigate and compare the efficacy of transbuccal paracetamol 125 mg with that of paracetamol 1g administered intravenously in patients with acute pain of moderate intensity accepted to emergency room following a minor trauma of the lower limbs and/or superiors. To this end, several pain scoring will be performed using a visual analogue scale (VAS) at various times after drug administration.
16174885|NCT01586143|Drug|Placebo|
16174886|NCT01586130|Other|Exercise in eccentric or concentric mode|In this therapeutic field, isokinetic exercises seem to have a better efficiency than other, more frequently used, kinds of exercises such as isometric or isotonic exercises.
16174887|NCT01586117|Drug|Amifostine|intrarectal Amifostine administration 1500mg QD x 5 weeks
16174888|NCT01586104|Radiation|intensity-modulated radiation therapy|Undergo cardiac-sparing whole lung IMRT
16174889|NCT01586091|Drug|Levocetirizine Oral Tablet|
16174890|NCT01586091|Drug|Fexofenadine 60 Mg Oral Tablet|
16174891|NCT01586091|Drug|Placebo Oral Tablet|
16174892|NCT01586065|Device|Continuous Glucose Monitor (CGM)|Use of CGM for 6 months
16174893|NCT01586065|Other|Fingerstick BGs only|No CGM - fingerstick BGs only
16174894|NCT01586052|Drug|Erythropoietin|250 IU/kg, Twice a week for 4 weeks
16174895|NCT01586039|Device|Visible light|We will compare the effects of two light sources, equated for visual stimulus (lux), on multiple non-visual responses to light including melatonin suppression before bedtime. We will compare a 90 lux exposure of a commercially available Compact Fluorescent Light (CFL) with a novel LED white light source that is depleted in the short-wavelength visible range (Biological Illumination LCC, FL).
16174896|NCT01586013|Drug|evaluation of propofol effect using BIS|propofol administered in target controlled infusion using the pharmacokinetic model of White
16174897|NCT01586000|Drug|10 µg/day E2 with NES 200® µg/day|10 µg/day E2 with NES 200® µg/day delivered by CVR continuously for 6 months (180 days)
16174898|NCT01586000|Drug|20 µg/day E2 with NES 200® µg/day|20 µg/day E2 with NES 200® µg/day delivered by CVR continuously for 6 months (180 days)
16174899|NCT01586000|Drug|40 µg/day E2 with NES 200® µg/day|40 µg/day E2 with NES 200® µg/day delivered by CVR continuously for 6 months (180 days)
16174900|NCT01585987|Biological|Ipilimumab|
16174902|NCT01585974|Other|No intervention|All dosage, frequency and duration for drugs will be under the decision of the treating physician
16174903|NCT01585961|Device|Catheter Ablation (NAVISTAR® THERMOCOOL® SF Catheter)|Administer anesthesia according to standard EP lab protocol, assess the fluid status of the subject (after each liter of infusate), determine if diuresis is necessary, and treat accordingly.
16174904|NCT01585935|Drug|SMOFLIPID|target dose: 3g/kg/d
16174905|NCT01585935|Drug|INTRALIPID|target dose: 3g/kg/d
16174906|NCT01585922|Procedure|noninvasive positive pressure ventilation (NPPV)|Use NPPV to treat the ARDS patients,and we choose the NPPV ventilators in which the FiO2 can be fixed, for example: the BiPAP Vision or V60 of Phillip Respironics.
16174907|NCT01585922|Procedure|invasive mechanical ventilation|Intubate and give invasive mechanical ventilation to the other group patients when they are allocated at once.
16174908|NCT01585909|Procedure|Gastroscopy|When gastroscopy is indicated for clinical reasons, duodenal biopsies to determine the activity of the brush border membrane enzymes intestinal alkaline phosphatase, maltase and lactase, as well as assessing brush border morphology are taken
16174909|NCT01585896|Other|Self-Help Group|The facilitated self-help group may last approximately 13 sessions. This treatment represents an empirically supported intervention for hoarding (Frost et al., 2011), based on a Facilitator's Manual (Maxner et al., 2010), which is a treatment manual based on the book Buried in Treasures: Help for Compulsive Acquiring, Saving, and Hoarding (Tolin, Frost, & Steketee, 2007).
16174910|NCT01585883|Behavioral|Self-management Intervention|Individual, face-to-face 7-session self-management intervention delivered by a specialist oncology nurse/clinical case manager as a home-based approach using a manual for each session. The intervention is delivered through scheduled home visits (7 sessions about one-hour in length), telephone coaching (2 sessions/week to reinforce use of strategies and for symptom monitoring: 15 minutes), and nurse moderated online peer chat or chat that is self-initiated at other times (7 weekly sessions about one hour in length).
16174911|NCT01585870|Drug|Sorafenib (Nexavar, BAY43-9006)|"Sorafenib (starting dose of 200 mg bid, level 1) administration will begin on Day 11 of Cycle 1, and will be administered twice daily continuously. If the combination is well tolerated, the dose will be escalated in new cohorts to 200 mg AM and 400 mg PM (level 2), then subsequently to 400 mg bid (level 3).
~If sorafenib starting dose (level 1) is not well tolerated with eribulin, the sorafenib dose will be de-escalated to 200 mg qd (Dose Level -1) in a new cohort."
16174912|NCT01585870|Drug|Eribulin|Eribulin: 1.4 mg/m2 as an intravenous infusion on Days 1 and 8 of each 21-day cycle.
16174913|NCT01585857|Biological|Autologous adipose derived stem cells administrated for intra-articular use|Each patient will receive one single administration of the cells and will be followed for 3 months. Each patients will be follow-up during one year with routinely examinations for safety issues.
16174914|NCT01585857|Biological|Autologous adipose derived stem cells administrated for intra-articular use|Each patient will receive one single administration of the cells and will be followed for 3 months. Each patients will be follow-up during one year with routinely examinations for safety issues. The first patient will be followed during 12 weeks before inclusion of the second patient.
16174915|NCT01585831|Drug|Testosterone gel 1%|Testosterone gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist after reviewing labs.
16174916|NCT01585831|Drug|Placebo gel|The placebo gel will be administered on a daily basis. The gel will be dispensed in a syringe, and the specific amount of gel to be applied each day will be determined by the study endocrinologist.
16174917|NCT01585818|Other|Low Glycemic Index (LGI) intervention arm|The general principles for the LGI intervention arm include the SDI principles and instructions on GI, identifying foods of different GI, switching to low GI food and having at least one low GI food per meal and suggested meals with recipes. Participants will also have the opportunity to attend sessions to learn how to cook meals with low GI.
16174918|NCT01585818|Other|Standard Diet Intervention|The general principles for the SDI arm are to provide an understanding of carbohydrates, be isocaloric based on assessment from the food diary/ recall and anthropometric measures, provide a personalised even distribution of carbohydrate throughout the day, have general recommendations such as reduction of fat, sodium, sugar and an increase in fibre. Participants will be provided with a list of carbohydrates to take during the intervention period and will be provided a supply of carbohydrates for that period
16174919|NCT01585805|Drug|Cisplatin|Given IV
16174920|NCT01585805|Drug|Gemcitabine|Given IV
16174921|NCT01585805|Drug|Gemcitabine Hydrochloride|Given IV
16174922|NCT01585805|Other|Laboratory Biomarker Analysis|Correlative studies
16174923|NCT01585805|Drug|Veliparib|Given PO
16174924|NCT01585792|Drug|TAK-875|
16174925|NCT01585792|Drug|TAK-875|
16174926|NCT01585792|Drug|Glimepiride|
16174927|NCT01585792|Drug|Placebo|
16174928|NCT01585779|Device|Contour 3D® implant for tricuspid valve repair|Tricuspid annuloplasty ring
16174929|NCT01585779|Device|Tri-Ad® implant for tricuspid valve repair|Tricuspid annuloplasty ring
16174930|NCT01585766|Drug|MEDI-551 30 MG-IV|Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.
16174931|NCT01585766|Drug|MEDI-551 60 MG-SC|Participants received SC injection of 60 mg MEDI-551 on Day 1.
16174932|NCT01585766|Drug|PLACEBO-IV-SC|Participants received either a fixed IV dose of placebo matching with MEDI- 551 on Days 1 and 15 or SC injection on Day 1
16174933|NCT01585766|Drug|MEDI-551 100 MG-IV|Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.
16174934|NCT01585766|Drug|MEDI-551 300 MG-SC|Participants received SC injection of 300 mg MEDI-551 on Day 1.
16174935|NCT01585766|Drug|MEDI-551 600 MG-IV|Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
16174936|NCT01585753|Drug|NRTI + PI|tenofovir zidovudine abacavir lamivudine emtricitabine ritonavir darunavir atazanavir lopinavir fosamprenavir
16174937|NCT01585753|Drug|maraviroc + PI|maraviroc ritonavir darunavir atazanavir lopinavir fosamprenavir
16174938|NCT01585753|Drug|maraviroc + NRTI|maraviroc tenofovir zidovudine abacavir lamivudine emtricitabine
16174939|NCT01585740|Drug|0.9% Normal Saline|Crystalloid fluid
16174940|NCT01585740|Drug|Ringer's Lactate|Crystalloid fluid
16174941|NCT01585727|Procedure|TME|Total mesorectal excision
16174944|NCT01585701|Biological|AT13148|Days 1, 3, 5 of a weekly schedule in dose escalation cohorts of three patients. Continuous dosing until progression or unacceptable toxicity develops up to a maximum of 12 cycles.
16174945|NCT01585688|Drug|hLL1-DOX (IMMU-115)|hLL1-DOX is administered intravenously at one of 4 dose levels on days 1, 4, 8 and 11 of 21-day treatment cycles, with up to 8 cycles administered.
16174946|NCT01585662|Procedure|EUS-guided pancreatic pseudocyst drainage|EUS-guided pancreatic pseudocyst drainage by one 8 French naso-pancreatic tube or 2-3 two pig tails- stents.
16174947|NCT01585649|Drug|Lipegfilgrastim|Lipegfilgrastim 100ug/kg
16174948|NCT01585636|Drug|SQ109|Single oral dose
16174949|NCT01585623|Drug|SAR302503|"Pharmaceutical form:capsule
~Route of administration: oral"
16174950|NCT01585623|Drug|omeprazol|"Pharmaceutical form:capsule
~Route of administration: oral"
16174951|NCT01585623|Drug|metoprolol|"Pharmaceutical form:tablet
~Route of administration: oral"
16174952|NCT01585623|Drug|midazolam|"Pharmaceutical form:solution
~Route of administration: oral"
16174953|NCT01585610|Behavioral|DVD Intervention|Four theory-based intervention DVDs will be provided to participants in this arm, the first in the home after Baseline assessment and the next 3 at 1-month intervals by mail. DVDs focus on motivating smoking cessation among people with mobility impairments using Behavioral Activation as the primary theoretical construct. Short (< 5 min.) phone calls will also be placed to each participant in between DVD deliveries and after receipt of DVD 4.
16174954|NCT01585610|Behavioral|Standard Care Printed Materials|Four sets of standard smoking cessation printed materials will be provided to participants in this arm, the first in the home after Baseline assessment and the next 3 at 1-month intervals by mail. Short (< 5 min.) phone calls will also be placed to each participant in between materials deliveries and after the 4th and final set is sent by mail.
16174955|NCT01585597|Device|Zoll- Coolgaurd 3000|Goal temperature of 33 degrees Centigrade for a duration of 12 hours and then actively rewarmed by 0.2 degrees Centigrade per hour.
16174956|NCT01585584|Drug|Boceprevir|All patients will receive a 4-week lead-in with Peginterferon and Ribavirin therapy, followed by 24 weeks of Pegetron 1.5microg/kg + weight-based ribavirin + boceprevir 800mg tid. HCV RNA (Cobas TaqMan) will be measured at baseline and at treatment weeks 4, 6,8,12,16,20,24 and 28, and post-treatment weeks 12 and 24 (to obtain SVR-12 and SVR-24 results).
16174957|NCT01585558|Drug|Ospemifene (Dose 1)|
16174958|NCT01585558|Drug|Ospemifene (Dose 2)|
16174959|NCT01585558|Drug|Placebo|
16174960|NCT01585519|Dietary Supplement|High/ Low Epicatechin Apples/ Apple Extract/ Granules|"(Group 1) Low Apple Diet (i.e. <1 portion per day) + 2 placebo capsules daily.
~(Group 2) 2 x High Epicatechin Apples daily + 2 placebo capsules daily.
~(Group 3) 2 x Low Epicatechin Apples daily + 2 placebo capsules daily.
~(Group 4) Low apple diet + 2 x 4.4g of apple granules daily + 2 placebo capsules daily.
~(Group 5) Low apple diet + 2 x Apple Extract Capsules daily."
16174961|NCT01585506|Other|No treatment given|"Patients to complete the WHO-5 Well-being Index questionnaire"
16174962|NCT01585506|Other|No treatment given|"Physicians to complete two questionnaires, Demographic Data and Disease and Treatment Course and Questionnaire of Potential Difficulties in the Period of Treatment Switching from Insulin to Its Analogues"
16174963|NCT01585493|Other|Treatment as usual|Treatment as usual. Patients will be affiliated with local out-patient clinics in secondary mental health services and they will have access to their own general practitioner. No formalized extra effort will be made to ensure treatment of physical disorders.Patients will be affiliated with local out-patient clinics in secondary
16174964|NCT01585493|Behavioral|Care coordinator|Treatment as usual plus a care coordinator (with a caseload of 25 patients) who will facilitate contact to primary care in order to ensure treatment of physical health problems,
16174965|NCT01585493|Behavioral|CHANGE|"Treatment as usual plus affiliation to a staffmember (caseload 10) from a CHANGE team who will provide individualized, adjusted implementation of widely recognized interventions, such as smoking cessation programmes, motivational interviewing, psychoeducation plus patient involvement in monitoring health statusA multidisciplinary CHANGE team will be established. Team members will be health professionals with experience in smoking cessation programmes or exercise programmes for mentally ill, and experts with competence in dietary issues.
~CHANGE treatment involve lifestyle coaching, education about diet and physical activity,16 networking and smoking cessation programs. The team members will act as lifestyle coaches for ten patients at a time, map lifestyle and explore and elicit patients' motivation for change."
16174966|NCT01585480|Behavioral|Weight Gain Prevention Intervention|"Behavioral Approaches
~Distribution of pedometers
~Traffic light labeling in worksite cafeteria and vending machines
~Informational & Persuasive Messages
~Stair use prompts
~Posters, pamphlets, table toppers
~Website
~Social Approaches
~a. Identification and training of influential employees (Peer Helpers) to shape healthy norms
~Environmental Changes
~Traffic light labeling
~1/2 portions at 1/2 price
~Walking routes
~Introduction of healthier foods
~Rearrangement of foods in the cafeteria
~Adjusting serving spoon size"
16174967|NCT01585441|Drug|Finasteride|Finasteride is available as white, round 5 mg tablets. During the masked period, the tablets are re-formulated in capsules with inactive ingredients. The re-formulated finasteride capsules are indistinguishable from the placebo capsules.
16174968|NCT01585441|Drug|Placebo|Capsule with no active ingredients to mimic finasteride
16174969|NCT01585428|Drug|Fludarabine|Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
16174970|NCT01585428|Drug|Cyclophosphamide|Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml in 5% dextrose in water (D5W) over 1 hr.
16174971|NCT01585428|Biological|Young TIL|Cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
16174972|NCT01585428|Drug|Aldesleukin|Aldesleukin 720,000 IU/kg intravenous (IV) (based on total body weight) over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
16174973|NCT01585415|Drug|Vemurafenib|Vemurafenib will administered orally twice a day at a dose of 960 mg from day -21 (+/- 7 days)until disease progression or patients are taken off protocol.
16174974|NCT01585415|Biological|Young TIL|Young TIL will be administered intravenously on day 0(1x10e9 to 2x10e11) in the Patient Care Unit over 20-30 minutes via non-filtered tubing, gently agitating the bag during infusion to prevent cell clumping.
16174975|NCT01585415|Drug|Cyclophosphamide|Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml D5W with Mesna 15 mg/kg/day X 2 days over 1 hr.
16174976|NCT01585415|Drug|Fludarabine|Fludarabine 25 mg/m2/day IVPB daily over 30 minutes for 5 days.
16174977|NCT01585415|Drug|Aldesleukin|Aldeskeukin 720,000 IU/kg IV (based on total body weight)over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)
16174978|NCT01585402|Drug|Etidronate|Didronel (etidronate disodium)- Didronel tablets contain either 200 mg or 400 mg of etidronate disodium, the disodium salt of (1-hydroxyethylidene) diphosphonic acid, for oral administration. This compound, also known as EHDP. regulates bone metabolism. It is a white powder, highly soluble in water. The 400 mg tablets are white capsule-shaped tablets with ED 400 on one side and G on the other side.
16174979|NCT01585402|Device|MRI Scan|Visit on day 0 and visit at 36 month - Exploratory MRI studies may be employed to evaluate the lumen of the artery and degree of collateral vessels, given that the highh degree of calcification is precluding that evaluation by CT.
16174980|NCT01585389|Genetic|gene expression analysis|
16174981|NCT01585389|Genetic|genetic linkage analysis|
16174982|NCT01585389|Genetic|microarray analysis|
16174983|NCT01585389|Other|immunohistochemistry staining method|
16174984|NCT01585389|Other|laboratory biomarker analysis|
16174985|NCT01585376|Genetic|mutation analysis|
16174986|NCT01585376|Genetic|nucleic acid sequencing|
16174987|NCT01585376|Other|laboratory biomarker analysis|
16174988|NCT01585350|Biological|MELITAC 12.1 + Montanide ISA-51 + lipopolysaccharide (LPS)|"Cohort 1 will be divided into three sub-groups and will receive:
~Group 1a: MELITAC 12.1 + lipopolysaccharide (LPS)
~Group 1b: MELITAC 12.1 + lipopolysaccharide (LPS) + Montanide adjuvant with vaccination #1
~Group 1c: MELITAC 12.1 + lipopolysaccharide (LPS) adjuvant + Montanide adjuvant with all vaccinations"
16174989|NCT01585350|Biological|MELITAC 12.1 + Montanide ISA-51 + polyICLC|"Cohort 2 will be divided into three sub-groups and will receive:
~Group 2a: MELITAC 12.1 + polyICLC adjuvant
~Group 2b: MELITAC 12.1 + polyICLC adjuvant + Montanide adjuvant with vaccination #1
~Group 2c: MELITAC 12.1 + polyICLC adjuvant + Montanide adjuvant with all vaccinations"
16174990|NCT01585324|Drug|peginterferon alfa-2a [Pegasys]|180 mcg subcutaneously weekly
16174991|NCT01585324|Drug|ribavirin [Copegus]|1000 mg or 1200 mg orally daily
16174992|NCT01585298|Drug|FTY720|
16174993|NCT01585285|Procedure|LIMA to SVG Bridge Technique|This surgical design use a composite-sequential venous graft to distribute left internal mammary artery (LIMA) inflow directly to the left anterior descending (LAD), but also to the other branches of the anterolateral territory thereby promoting a higher flow through the LIMA pedicle. It is constructed using a short saphenous vein graft (SVG) bridge interposed between the LAD and one (or more) other anterolateral targets, with the LIMA grafted on the hood of the SVG just above the LAD anastomosis.
16174994|NCT01585285|Procedure|Conventional CABG|Conventional coronary artery bypass grafting (CABG) strategy with left internal mammary artery (LIMA) graft to the left anterior descending (LAD) and separate sequential aorto-coronary saphenous vein grafts (SVG) to the others anterolateral targets
16174995|NCT01585272|Drug|ENA713|
16174996|NCT01585259|Drug|Anfibatide|Snake venom
16174997|NCT01585259|Drug|Placebo|Saline
16174998|NCT01585246|Drug|Saw Palmetto|1 of 3 doses of Saw Palmetto (320, 640, 960mg/day)
16174999|NCT01585246|Drug|soybean oil soft gel|placebo (soybean oil soft gel)
16175000|NCT01585233|Drug|ASKP1240|Intravenous
16175001|NCT01585233|Drug|Placebo|Intravenous
16175002|NCT01585220|Device|HA filler|The study device and comparator device will be intradermally injected to each left and right nasolabial fold according to the randomization.
16175003|NCT01585207|Drug|vigabatrin|3 tablets, bid for 8 weeks
16175004|NCT01585194|Biological|Ipilimumab|Given IV
16175005|NCT01585194|Other|Laboratory Biomarker Analysis|Correlative studies
16175006|NCT01585194|Biological|Nivolumab|Given IV
16175007|NCT01585181|Biological|PXVX0200|Single dose; liquid suspension after reconstitution with buffer; 2x108 to 2x109 CFU in a liquid suspension
16175008|NCT01585181|Biological|Placebo|Approx 2 grams of lactose reconstituted in water
16175009|NCT01585168|Drug|Memantine|Memantine is a low-side-effect NMDA receptor antagonist usually administered therapeutically to elderly persons with moderately severe Alzheimer's disease in typical doses of 10-20 mg daily. In this study, single doses of 40 mg are administered.
16175010|NCT01585168|Drug|Placebo|Identically appearing sugar pill, given orally
16175011|NCT01585155|Drug|TA-650|TA-650 will be intravenously infused at 5 mg/kg as an induction regimen at Weeks 0, 2, 6. For subjects who meet the responder criteria, TA-650 will be administered at 8-week intervals thereafter until week 22.
16175012|NCT01585142|Other|Test formula|Infant Formulas in powder in single-serve capsules (with a machine for dispensing, four consecutive formulas with customized composition
16175013|NCT01585129|Drug|Postpartum Antibiotics|Patients randomized into this arm will receive one additional dose of gentamicin (1.5 mg/kg) and clindamycin (900mg) in the postpartum setting.
16175014|NCT01585129|Drug|No postpartum antibiotics|Patients randomized into this arm will not receive any postpartum antibiotics after delivery. They will be managed identically to the other arm in terms of chorioamnionitis (fever pre-delivery). The groups will be managed identically if endometritis (post-partum fever) develops.
16175016|NCT01585090|Other|doing strengthening exercises of pelvic floor muscles|
16175265|NCT01583075|Procedure|single ring pulmonary vein ablation|single ring pulmonary vein ablation
16175017|NCT01585077|Biological|P. vivax infected mosquito bites|All volunteers will receive one dose of 2-4 P. vivax infected mosquito bites. All the mosquitoes will correspond to the same mosquito batch to make sure that all volunteers receive the same P. vivax strain.
16175018|NCT01585064|Other|DAS28-IOMS|Investigators randomized to DAS28-IOMS will be expected to adapt their therapeutic approaches in relation to the defined targets, i.e. to optimize adalimumab treatment according to individual patient's responses to treatment in order to achieve a DAS28 score of < 2.4.
16175019|NCT01585064|Other|0SJ-IOMS|Investigators randomized to 0SJ-IOMS will be expected to adapt their therapeutic approaches in relation to the defined targets, i.e. to optimize adalimumab treatment according to individual patient's responses to treatment in order to achieve a swollen joint count of 0.
16175020|NCT01585064|Other|Routine Care (RC)|Investigators randomized to RC will NOT be expected to adapt their therapeutic approaches to a pre-defined target. They will optimize adalimumab treatment according to individual patient's responses to treatment as per routine care and according to their own judgment.
16175021|NCT01585051|Drug|25(OH) vitamin D|300 000 U intramuscularly, one dosage, in subjects with 25 (OH) vit D levels below 80 nmol/L, another dosage of 150 000 U after 3 months if 25(OH)vit D levels continue to be below 80 nmol/L.
16175022|NCT01585051|Drug|0.9 % NaCl|1 ml of 0.9 % of NaCl at the beginning and 0.5 ml of 0.9 % NaCl after three months
16175023|NCT01585038|Drug|Efavirenz|600mg orally every evening
16175024|NCT01585038|Drug|Rilpivirine|25mg orally once daily
16175025|NCT01585025|Drug|Obeticholic acid|Day -14 to Day 0 subjects will stop their usual diarrhoeal medication. Day 1 to Day 15 Obeticholic acid 25mg tablet will be administered to subjects once daily in the morning. Day 16 to day 28 normal diarrhoeal medication may be re-commenced.
16175026|NCT01585012|Device|Cervical cap (Focus Touch™ Conception System)|Cervical cap
16175027|NCT01584999|Biological|Blood transfusion|RBCs have been transfused in septic patient admitted in ICU
16175028|NCT01584986|Biological|ACP injections|Peripheral blood-derived, ex vivo expanded autologous angiogenic cell precursors (ACPs)
16175029|NCT01584960|Behavioral|endurance training|2 years of home-based endurance training
16175030|NCT01584947|Drug|Bupivacaine|Bupivacaine lozenge taken 3 times a day for two weeks
16175031|NCT01584947|Drug|Placebo|Placebo lozenge taken three times a day for two weeks
16175032|NCT01584934|Drug|Sodium oxybate|Treatment is started and continued for 6 weeks at patient's home. Patients receive 3g/night during the first week, and 4,5 g/night during the second week. After the second week, patients have their dose increased to 6 g/night during 6 weeks. A washout period of 4 weeks is installed to withdraw from treatment. Patients receive 4,5 g/night for 1 week, followed by 3g/night for 1 week. The next 2 weeks, patients are not treated.
16175033|NCT01584934|Drug|Placebo|Placebo treatment is started and continued for 6 weeks at patient's home. Patients receive 3 g/night during the first week and 4.5 g/night during the second week. After the second week, patients have their dose increased to 6 g/night during 6 weeks. A washout period of 4 weeks is installed to withdraw from treatment. Patients receive 4.5 g/night for 1 week, followed by 3 g/night for 1 week. The next 2 weeks, patients are not treated.
16175034|NCT01584921|Drug|Erythropoietin (Epoetin-beta, NeoRecormon®)|5000 IU/ml of NeoRecormon (Epoetin beta) is given subcutaneously as one ml before 10 O-clock a.m. on day 1,3,5,7,9,11 and 13. On day 1 and 3 5000 IU is given in one syringe and five ml of saline in total is given in five other syringes in order to maintain the double blinding. On day 2 six syringes of a total of 6 ml of saline is given in six syringes.
16175035|NCT01584921|Drug|Erythropoietin (Epoetin-beta, NeoRecormon®)|"30.000 IU of NeoRecormon (Epoetin beta) is given subcutaneously as a total of six ml (5.000 IU/ml) given in six syringes before 10 O-clock a.m. on day 1,2 and 3.
~On day 5,7,9,11 and 13 six ml of saline in total is given in six syringes in order to maintain the double blinding."
16175036|NCT01584921|Drug|Placebo|1 ml of saline (Sodium Chloride 9 mg/ml) is given subcutaneously before 10 O-clock a.m. on day 1,2,3,5,7,9,11 and 13. On day 1,2 and 3 six ml in total is given in six syringes in order to maintain the double blinding.
16175037|NCT01584895|Behavioral|Cardiac Rehabilitation|A standard cardiac rehabilitation program consisting of 3 days per week of supervised exercise and education.
16175038|NCT01584882|Behavioral|CATI Tool|Using Screening for drug use, Brief Intervention, Referral to Treatment (SBIRT) as a model, a CATI tool was designed for the Electronic Dental Record which required assessment of 4 variables for patients reporting cigarettes use: 1) number of cigarettes daily, 2) how soon upon waking the first cigarette was smoked, 3) interest in quitting, and 4) previous quit attempts. Level of dependency was calculated and displayed in the health history using the Heavy Smoking Index. Pop-up provider scripts were generated using rule-based algorithms. Links to printable patient education materials on the quit line and on medications to help quit smoking were embedded in the scripts window. The tool automatically recorded tobacco-cessation details.
16175039|NCT01584869|Device|capsule endoscopy|
16175040|NCT01584843|Drug|GSK1358820|IM injection of Botulinum Toxin Type A
16175041|NCT01584830|Drug|Regorafenib (BAY73-4506)|Regorafenib BAY73-4506 will be given 3 weeks on/1 week off (160 mg od po.)
16175042|NCT01584830|Drug|Placebo|Placebo will be given 3 weeks on/1 week off (160 mg od po.)
16175043|NCT01584817|Other|telephone education|A repeated instruction by telephone on the day before colonoscopy was conducted
16175044|NCT01584804|Drug|Su-Huang antitussive capsule|Su-Huang antitussive capsule (0.45g) 3 capsules Tid for 2 weeks (swallowed by warm water at 0.5-1h after each meal)
16175045|NCT01584804|Drug|Sugar pill|Sugar pill 3 capsules Tid for 2 weeks (swallowed by warm water at 0.5-1h after each meal)
16175046|NCT01584791|Drug|clopidogrel napadisilate + aspirin|clopidogrel napadisilate 75mg + aspirin 100mg
16175047|NCT01584791|Drug|clopidogrel bisulfate + aspirin|clopidogrel bisulfate 75mg + aspirin 100mg
16175048|NCT01584778|Other|eosinophil cationic protein|Serum eosinophil cationic protein levels
16175049|NCT01584765|Drug|Prescription drugs with known hepatotoxicity|14 prescription drugs with known hepatotoxicity : Amoxicillin/clavulanate, nitrofurantoin, isoniazid, trimethoprim-sulfamethoxazole, duloxetine, valproate, interferon-beta, ciprofloxacin, lamotrigine, phenytoin, diclofenac, terbinafine, levofloxacin, aripiprazole
16175050|NCT01584752|Procedure|Gore-BioA Fistula Plug|Gore-BioA Fistula Plug
16175051|NCT01584739|Drug|AZD8683|Multiple dose, oral inhalation (Healthy volunteers) Multiple dose, oral inhalation (COPD patients)
16175052|NCT01584739|Drug|Placebo|Multiple dose, oral inhalation (Healthy volunteers) Multiple dose, oral inhalation (COPD patients
16175053|NCT01584726|Drug|Magnesium Sulfate|single dose of magnesium sulfate nebulization
16175054|NCT01584713|Drug|Adipose-derived stem cells without expanded|Administration will be intralesional injection of cells suspension. They will be placed into fistula walls
16175055|NCT01584700|Procedure|Renal Artery Denervation|Radiofrequency ablation of the renal artery sympathetic outflow tract.
16175056|NCT01584687|Biological|Omalizumab|The patients will receive Omalizumab according to their age and weight for 4 months.
16175057|NCT01584674|Device|KLOX Biophotonic System|KLOX Biophotonic System (KLOX KLGA0105-01 photo-converter gel and KLOX THERA lamp) will be administered twice a week for 6 weeks followed by a 6-week follow up period
16175058|NCT01584661|Behavioral|Dietary recommendations|
16175059|NCT01584648|Drug|Dabrafenib|Dabrafenib 150 mg twice daily
16175060|NCT01584648|Drug|Trametinib|Trametinib 2 mg once daily
16175061|NCT01584648|Drug|Trametinib placebo|Dabrafenib 150 mg twice daily and trametinib placebo
16175062|NCT01584635|Procedure|Peroral Endoscopic Myotomy a less invasive treatment for Achalasia|In this study we will follow patients undergoing Peroral Endoscopic Myotomy at 1 and 6 months post surgery,1,2,3,4,and 5 years post surgery with esophageal high resolution Manometry and a Barium Esophagram when it is not standard of care. We will have you fill out a symptom questionnaire at each visit
16175063|NCT01584622|Device|CADence System|Non-invasive detection of > or equal to 50% stenosis in any of the major coronary arteries.
16175064|NCT01584609|Device|Penumbra System with Separator 3D|The Separator 3D is an additional Separator with a new tip configuration for the Penumbra System.
16175065|NCT01584609|Device|Penumbra System alone|The Penumbra System® is a new generation of neuro-embolectomy devices specifically designed to remove thrombus through aspiration.The treatment paradigm of this System involves the introduction of the Reperfusion Catheter through a guide catheter into the intracranial vasculature, and guided over an appropriate guidewire to the site of primary occlusion. The Reperfusion Catheter is used in parallel with the Separator and an aspiration source (Aspiration Pump) to separate the thrombus and aspirate it from the occluded vessel.
16175066|NCT01584596|Behavioral|Adapted Dietary Guidelines|"This group will receive dietary counseling to reduce their overall dietary food intake by 100 kcal/day, as prescribed by the dietary guidelines for the prevention of weight gain, and to follow an adapted eating pattern (to be determined from formative research in Phase I research).
~The education sessions will be organized into two phases: an initial adoption phase and a subsequent adherence phase. During the adoption phase, participants will meet for one session per week for the first four weeks. During this session their interim weight will be recorded before they receive their session. During the adherence phase, participants will be contacted by telephone biweekly by a trained interventionist."
16175067|NCT01584596|Behavioral|Adapted Physical Activity Guidelines|The physical activity education sessions will be organized into two phases: an initial adoption phase and a subsequent adherence phase. The adoption phase will be for 1 hour and 45 minutes for the first 4 weeks with classes occurring once per week in conjunction with the DG education classes. During the adoption phase, participants monitor their own walking using pedometers and attend weekly group meetings to review the previous week's walking behaviors, discuss preferred strategies for success, and set personally relevant and incremental steps/day goals. During the adherence phase (the remaining 8 weeks), participants will continue with their self-monitoring and goal-setting (using their pedometers), with reduced contact with the study interventionists over the telephone (biweekly).
16175068|NCT01584570|Drug|0.5 mcg/kg IV infusion for 10 min, 1.0 mcg/kg IV infusion for 10 min|ECG monitoring for evaluation of QTc interval
16175069|NCT01584557|Drug|Tolvaptan or Samsca|uncoated tablet, 30mg, once per day, for up to 7 days.
16175070|NCT01584557|Drug|placebo or sugar pill|sugar pill
16175071|NCT01584544|Drug|capecitabine|oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
16175072|NCT01584544|Drug|Capecitabine|oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
16175073|NCT01584544|Drug|Capecitabine|oral pills, 1350mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
16175074|NCT01584544|Drug|Capecitabine|oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
16175075|NCT01584544|Drug|Capecitabine|oral pills, 1650mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation
16175076|NCT01584531|Drug|rigosertib|"Rigosertib sodium will be available as soft gel capsules in strengths of 280 mg and 70 mg. Rigosertib will be administered on an outpatient basis.
~Patients will take a 560 mg dose (e.g., 2 x 280 mg capsules) of oral rigosertib in the morning and 280 mg dose (e.g., 1 x 280 mg capsules) of oral rigosertib every day of 21-day cycles. Rigosertib should be taken in a fasting state (defined by at least 30 minutes before next meal) BID at 12 hr intervals (with a window of 2 hr). Any vomited dose will be reported as a missed dose.
~The patient will fill a diary indicating the day and time of drug intake."
16175077|NCT01584518|Drug|Furosemide|Based on clinical standard per clinician
16175081|NCT01584492|Drug|beclomethasone+formoterol 50/6 (1 inhalation)|CHF 1535 50/6 (fixed combination of extrafine beclomethasone dipropionate 50 µg + formoterol fumarate 6 µg/metered dose) administered via a pMDI with spacer
16175082|NCT01584492|Drug|CHF 1535 50/6 (2 inhalations)|CHF 1535 50/6 (fixed combination of extrafine beclomethasone dipropionate 50 µg + formoterol fumarate 6 µg/metered dose) administered via a pMDI with spacer
16175083|NCT01584492|Drug|CHF 1535 50/6 (4 inhalations)|CHF 1535 50/6 (fixed combination of extrafine beclomethasone dipropionate 50 µg + formoterol fumarate 6 µg/metered dose) administered via a pMDI with spacer
16175084|NCT01584492|Drug|Formoterol + Beclomethasone dipropionate|"Formoterol HFA pMDI 6 µg / actuation
~Extrafine BDP HFA pMDI 50 µg/actuation"
16175085|NCT01584492|Drug|Placebo (6 inhalations)|Matched placebo via pMDI
16175123|NCT01584167|Drug|Cold crystalloid infusions, 0.9%NaCl or Ringer's solution|Infusion of 2L cold crystalloid solution (4°C) over 30 minutes
16175124|NCT01584167|Device|EMCOOLS Flex.Pads|Passive whole-body surface cooling with 10 EMCOOLS Flex.Pads
16175086|NCT01584466|Drug|Paliperidone|"The starting regimen will be a 'loading dose' strategy whereby the first injection will be 234 mg given on treatment week 0,day 1 and 156 mg (2nd injection) will be given 1 week later (days 5-9). Both are recommended to be administered in the deltoid muscle (PI 2011). Following the second dose, monthly maintenance doses will be administered in either the deltoid or gluteal muscle (PI 2011). The monthly (± 7 days) maintenance dose will be 117 mg.
~Discontinuation of oral antipsychotics is recommended after the subjects receive paliperidone palmitate injection on Week 0/day 1. Continued oral antipsychotics may be used only if necessary."
16175087|NCT01584453|Drug|Sodium Nitrite|A bolus of sodium nitrite solution (1.8 micromol in 10 ml PRe-diluted in 0.9% sodium chloride in a syringe) will be delivered over 30-60 seconds via intracoronary injection initiated during the re-establishment of antegrade epicardial flow with PPCI.
16175088|NCT01584453|Drug|Sodium Chloride Placebo|The control intervention is a bolus of 0.9% sodium chloride solution (prepared with an identical appearance to the sodium nitrite).
16175089|NCT01584440|Drug|AVP-923 (dextromethorphan/quinidine)|AVP-923 capsules administered twice a day over a 10-week period
16175090|NCT01584440|Drug|Placebo|Placebo capsules administered twice a day over a 10-week period
16175091|NCT01584427|Dietary Supplement|Healthy Carbohydrate Diet vs. Western Style Diet|Cross over study with two intervention diets. Healthy Carbohydrate Diet with approximally 55 g of dietary fibers (arabinoxylan and resistant starch)compared with western style diet with low content of dietary fibers.
16175092|NCT01584388|Drug|Rituximab|Rituximab 1000 mg IV times two doses, separated by approximately 15 days.
16175093|NCT01584375|Other|Flat midline head position|"Infant's chin will be kept at a 90±5 degree angle to the bed (the chin and nose being in line with the sternum) throughout the first 168 hours of life.
~--------------------------------------------------------------------------------"
16175094|NCT01584375|Other|Right flat lateral head position|Infant's head will be tilted 85-90 degrees to right side (approximately the entire chin beyond the right nipple line) throughout the first 168 hours of life.
16175095|NCT01584362|Drug|oxfendazole|administration of a single oral 1.0 mg/kg dose of oxfendazole
16175096|NCT01584362|Drug|placebo|single oral dose of placebo
16175097|NCT01584362|Drug|oxfendazole|administration of a single oral 3.0 mg/kg dose of oxfendazole
16175098|NCT01584362|Drug|oxfendazole|administration of a single oral 0.3 mg/kg dose of oxfendazole
16175099|NCT01584362|Drug|oxfendazole|administration of a single oral 10 mg/kg dose of oxfendazole
16175100|NCT01584362|Drug|oxfendazole|administration of a single oral 20 mg/kg dose of oxfendazole
16175101|NCT01584362|Drug|oxfendazole|administration of a single oral 30 mg/kg dose of oxfendazole
16175102|NCT01584336|Procedure|LATG|"After laparoscopic observation, the surgeon must check the possibility of laparoscopic surgery (without the serosal invasion of cancer or peritoneal metastasis or lymph node metastasis to splenic hilum). If the gastric cancer with serosal invasion or grossly lymph node metastasis to splenic hilum, operator must convert the operation method to open gastrectomy
~The operator undergoes the laparoscopic total gastrectomy with lymph node dissection(including the status of lymph nodes - No #1,2,3,4sa,4sb,4d,5,6,7,8a,9,11p and 11d, and/or 12a).
~The operator can choose any reconstruction method of esophagojejunostomy according to surgeon's preference.
~After then, the operator performs the jejunojejunostomy."
16175103|NCT01584323|Dietary Supplement|Pomgranate pills|"Treatment arm will receive The POMx pomegranate 1,000 mg capsule a day for maximum of two weeks or until they deliver if occurs before
~The POMx pomegranate 1,000 mg capsule contains at least 800 mg natural polyphenol using a pomegranate polyphenol standard and is comparable to mg/8 oz juice.(attached is confirmation Similarity of Pomegranate Juice and POMx Polyphenols)"
16175104|NCT01584323|Dietary Supplement|Placebo pills|The placebo group will receive placebo pills , for maximum of two weeks or until they deliver if occurs before The palecbo capsule contains gelatin and lactose. The capsuls are manufactured by the hospital pharmacy.All the components are medically approved fot use during pregnancy
16175105|NCT01584310|Other|questionnaire STAMP and dietary|Children will undergo a complete evaluation by an investigating dietician and assessment by the STAMP tool in order to determine the extent of the nutritional risk on a numerical scale. According to findings children will get the dietary recommendations.
16175106|NCT01584310|Other|No STAMP using|No intervention
16175107|NCT01584297|Drug|Ketoconazole|Patients will receive ketoconazole, 400 mg three times a day. Study treatment period will be during 6 months or up to progression disease, unacceptable toxicity, death or withdraw from the study for any reason.
16175108|NCT01584284|Biological|GL-ONC1|A genetically-engineered vaccinia virus administered via intravenous infusion . Cohorts 1, 2, 3: Frequency: 1x in Week 1; Cohort 4: 1x again 1x in Week 2; Cohort 5: 1x Week 1, 1x Week 2, 1x Week 3, 1x Week 4.
16175109|NCT01584271|Device|Natural Ear Comfort(TM), a botanical ear drops product|"Ear Comfort(TM): active ingredients - Thyme essential oil & Camomile extract. Inactive ingredients: anhydrous glycerin and a small quantity of surfactant.
~Dex-Otic(R): Dexamethasone sodium phosphate 1mg; neomycin sulfate 5mg; polymixin B sulfate 10,000 units.
~Inactive ingredients: propylene glycol, sodium acetate anhydrous, phenyl mercuric acetate, purified water.
~Otidin(R): Tetracaine HCL 0.5%; antipyrine 5% in anhydrous glycerin."
16175110|NCT01584258|Procedure|Laproscopic Prostatectomy|
16175111|NCT01584258|Radiation|Conventionally Fractionated Prostate Radiotherapy|Conventional fractionation delivered to a dose of 78 Gy in 2 Gy fractions.
16175112|NCT01584258|Radiation|Prostate SBRT|Prostate SBRT delivered to a dose of 36.25 Gy in 5 fractions.
16175113|NCT01584245|Other|Amino Acid formula|
16175114|NCT01584232|Drug|LY2189265|
16175115|NCT01584232|Drug|Insulin glargine|
16175116|NCT01584232|Drug|Sulfonylureas (SU)|
16175117|NCT01584232|Drug|Biguanide (BG)|
16175118|NCT01584206|Drug|Ezetimibe|10mg ezetimibe/day, at least 4 months
16175119|NCT01584193|Procedure|Ultrasound-guided subclavian vein puncture|Central venous access port implementation through ultrasound-guided subclavian vein puncture and Seldinger technique
16175120|NCT01584193|Procedure|Cephalic vein dissection|Central venous access port implementation through cephalic vein dissection and cutdown
16175121|NCT01584180|Drug|Cold crystalloid infusions, 0.9%NaCl or Ringer's|Infusion of max. 1L cold crystalloid solution (4°C) over 15 minutes
16175122|NCT01584180|Device|EMCOOLS Brain.Pad|Passive external neck cooling with 1 EMCOOLS Brain.Pad
16175127|NCT01584115|Biological|NY-ESO-1 combined with MPLA|Each patient will receive six doses of the formulation, administered intra-muscular, with an interval of 4 weeks between doses, and the first immunization performed 6 weeks after the completion of standard treatment. NY-ESO-1 (250 mcg) amd MPLA (100 mcg).
16175128|NCT01584115|Biological|NY-ESO-1 combined with MPLA vaccine|Immunization os cancer patients with NY-ESO-1 combined with MPLA vaccine
16175129|NCT01584102|Behavioral|group fitness + education|15 weeks biweekly group fitness + 15 weekly nutrition and physical activity education
16175130|NCT01584102|Behavioral|group fitness classes only|15 weeks biweekly group fitness
16175131|NCT01584076|Drug|Donepezil|"Oral Donepezil Daily
~Initial Dosage: Donepezil 5 mg tablets will be used. 1/2 tablet (≈2.5 mg)/day for 8 to 17 year olds OR 1 tablet (5 mg)/day for ≥18 year olds.
~Dosage Escalation: Donepezil may be increased by 1/2 tablet (≈2.5 mg)/day every 4 weeks if the amblyopic eye visual acuity has not improved by ≥5 letters or 1 logMAR line to a maximum dosage of 1 1/2 tablets (≈7.5 mg)/day for 8 to 17 year olds OR 2 tablets (10 mg)/day for ≥18 year olds."
16175132|NCT01584076|Other|Patching|Patching: 2 hours of daily patching will also be prescribed for 8 to 17 year olds only.
16175133|NCT01584063|Behavioral|Healthy MOMs Healthy Lifestyle Intervention|These women received the culturally tailored Healthy MOMs Healthy Lifestyle Intervention, which included social support from Women's Health Advocates (community health workers) and peers, and the Healthy MOMs curriculum. This intervention curriculum covered topics related to healthy eating, physical activity, and stress management during pregnancy and postpartum. General information about pregnancy and the postpartum period were also provided. This intervention was delivered during 10 group meetings and 4 home visits.
16175134|NCT01584050|Dietary Supplement|L-5-methyltetrahydrofolate (Metafolin ®)|dosage: 1000 μg, frequency: once daily, duration: 12 weeks
16175135|NCT01584050|Dietary Supplement|folic acid|dosage: 1000 μg, frequency: once daily, duration: 12 weeks
16175136|NCT01584050|Dietary Supplement|Placebo|frequency: once daily, duration: 12 weeks
16175137|NCT01584024|Device|Resin infiltration|"Baseline treatment of one caries lesion with resin infiltration therapy, in addition to preventative measures and behavioral modification.
~ICON product: FDA-510(k): K100062"
16175138|NCT01584024|Device|Sham treatment|Baseline treatment of one caries lesion with sham treatment, in addition to preventative measures and behavioral modification.
16175139|NCT01584011|Other|taste measurement|Taste measurements with Electrogustometry and Filter paper test before and after surgery until one year after surgery
16175140|NCT01584011|Other|Symptom questionnaire|Answering a symptom questionnaire before and after surgery until one year after surgery
16175141|NCT01584011|Behavioral|Quality of life questionnaire|Answering a quality of life questionnaire before and one year after surgery
16175142|NCT01584011|Other|Nerve sample|Collect nerve samples from patients undergoing surgery because of vestibular schwannoma, chronic otitis media or cholesteatoma where the nerve cant be saved during planned operation.
16175143|NCT01583998|Behavioral|e-MBC|antidepressant treatment
16175144|NCT01583985|Other|Opioid-intensive prescribing strategy|The opioid-intensive arm emphasizes early use of strong opioid analgesics. Medications will be individually adjusted according to patient preferences and responses.
16175145|NCT01583985|Other|Opioid-avoidant prescribing strategy|The opioid-avoidant prescribing strategy emphasizes non-opioid medications from several drug classes. Medications will be individually adjusted according to patient preferences and responses.
16175146|NCT01583972|Dietary Supplement|retinyl palmitate|50,000 IU vitamin A in oil given within 48 h of birth from single-dose capsule
16175147|NCT01583972|Dietary Supplement|Placebo|edible oil used as diluent for vitamin A given within 48 h of birth from single-dose capsule identical in appearance to vitamin A capsule
16175148|NCT01583959|Drug|Folic Acid|Folic acid tablets 5 mg
16175149|NCT01583959|Drug|Placebo|Matched placebo to folic acid 5 mg tables, to be given for 4 days a week
16175150|NCT01583933|Device|Essix retainer|"The essix retainer is made in a thermoforming copolyester 0.75mm (0.30 , it processed gives a thickness of 0.015 approximately. Retainer will be used molar to molar. subjects in this arm will have this retainer for 24 hours a day for 6 months, they won´t have this device for food intake."
16175151|NCT01583933|Device|Hawley retainer|subjects in this arm will have the retainer for 24 hours a day for 6 months. During food intake they won´t have this device.
16175152|NCT01583920|Radiation|focal salvage HDR prostate brachytherapy|Treatment will be delivered using 192-Ir HDR afterloading. Dose prescription is 2 fractions of 13.5 Gy each, delivered 1 week apart.
16175153|NCT01583881|Procedure|renal denervation|Renal denervation
16175154|NCT01583868|Device|B&L RD2135-01 lens C|Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.
16175155|NCT01583868|Device|B&L RD2135-01 lens D|Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.
16175156|NCT01583868|Device|PureVision2|Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.
16175157|NCT01583868|Device|Air Optix Aqua|Lenses will be worn on a daily wear basis for 1 week. Lens care solution and lens cases will be provided for daily rinsing, cleaning, disinfecting, and storing the lenses. Rewetting drops will be provided for use as needed during the study.
16175158|NCT01583855|Procedure|Catheter ablation for atrial fibrillation, manual|Ablation for atrial fibrillation will be performed manually
16175159|NCT01583855|Device|Ablation using Amigo remote catheter system|Atrial fibrillation ablation will be performed using the Amigo remote catheter system
16175160|NCT01583842|Drug|124I-Metaiodobenzylguanidine (MIBG) (no-carrier added)|"124I-MIBG (no-carrier added) Administration (infusion, 1-2 minutes) followed by sequential PET/CT dosimetry scans on Days 0, 1, 2 and 5.
~Optional 124I-MIBG (no-carrier added) Administration & PET/CT scan 6 weeks later."
16175161|NCT01583842|Drug|124I-MIBG (carrier added)|"124I-MIBG (carrier added) Administration (infusion, 60 minutes) followed by sequential PET/CT dosimetry scans on Days 0, 1, 2 and 5.
~Optional 124I-MIBG (carrier added) Administration & PET/CT scan 6 weeks later."
16175162|NCT01583842|Procedure|Positron Emission Tomography (PET) /Computerized tomography (CT)|A PET scan measures important body functions, such as metabolism. CT imaging uses special x-ray equipment, and in some cases a contrast material, to produce multiple images of the inside of the body. Combined PET/CT scans combine the processes of both a PET and CT at the same time.
16175163|NCT01583829|Behavioral|Neurofeedback|3 times per week for 45 minutes for a total of 40 sessions
16175164|NCT01583829|Behavioral|Cognitive Training|3 times per week for 45 minutes for a total of 40 sessions
16175165|NCT01583829|Other|Waitlist Control|6 30 minute calm breathing sessions over the course of 4 months
16175166|NCT01583816|Drug|Resiquimod 0.03%|topical application
16175167|NCT01583816|Drug|Resiquimod 0.01%|topical application
16175168|NCT01583816|Drug|placebo|topical application
16175169|NCT01583777|Drug|Belinostat|"On Day 1, a single dose of 14C-labeled belinostat (approximately 94 to 105 µCi, 1500 mg) will be administered to the patient as a 30-minute IV infusion.
~After Cycle 1 evaluations are completed, and if it is in the best interest of the patient, patients may receive additional cycles of non-radiolabeled belinostat until disease progression, unacceptable toxicity, or initiation of new anticancer therapy. After Cycle 1, Day 21, non radiolabeled belinostat will be administered IV as a 30 -45 minute infusion of 1000 mg/m2 on Days 1 through 5 every 21 days."
16175170|NCT01583751|Procedure|videoendoscopic resection of pilonidal sinus|Resection of pilonidal sinus tissue with videoendoscopic approach.
16175171|NCT01583738|Drug|V0251|single dose
16175172|NCT01583738|Drug|placebo|single dose
16175173|NCT01583725|Procedure|Liquid meal responses|Subject ingests a meal-replacement shake and gut peptide levels are measured before and after intake.
16175174|NCT01583725|Behavioral|fMRI responses to food-cues|Subjects undergo a 40 min fMRI neuroimaging session while receiving auditory and visual food cues.
16175175|NCT01583712|Procedure|Confocal laser endomicroscopy|Endomicroscopy of the upper gastrointestinal tract including endomicroscopic pictures taken every ten centimetres in the small bowel, gastric antrum, gastric corpus and esophagus.
16175176|NCT01583712|Device|Confocal Laser Endomicroscope|Pentax EC-3870 CIFK with the ISC-1000 confocal endomicroscopy processor - Pentax, Tokyo, Japan and Optiscan Pty Ltd, Notting Hill, Victoria, Australia
16175177|NCT01583699|Procedure|Confocal laser endomicroscopy|Endomicroscopy of the upper gastrointestinal tract to capture endomicroscopic pictures from the small bowel, stomach and esophagus.
16175178|NCT01583699|Device|Confocal Laser Endomicroscope|Pentax EC-3870 CIFK with the ISC-1000 confocal endomicroscopy processor - Pentax, Tokyo, Japan and Optiscan Pty Ltd, Notting Hill, Victoria, Australia
16175179|NCT01583686|Drug|Fludarabine|Days -5 to Day -1: Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
16175180|NCT01583686|Biological|Anti-mesothelin chimeric T cell receptor (CAR) transduced peripheral blood lymphocytes (PBL)|Day 0: Cells will be infused intravenously (IV) on the Patient Care Unit over 20 to 30 minutes.
16175181|NCT01583686|Drug|Cyclophosphamide|Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml 5% dextrose in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
16175182|NCT01583686|Drug|Aldesleukin|Aldesleukin 72,000 IU/kg intravenous (IV) (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses).
16175183|NCT01583673|Other|Amino Acid Formula|Subjects will be fed the assigned study formula from enrollment to 4 months (112 days) of age.Infants will be fed orally, ad libitum with the assigned formula
16175184|NCT01583673|Other|Amino Acid formula|Subjects will be fed the assigned study formula from enrollment to 4 months (112 days) of age.Infants will be fed orally, ad libitum with the assigned formula
16175185|NCT01583660|Drug|celecoxib|200mg, PO.Bid, last from admission to hospital to one week after operation.
16175186|NCT01583660|Drug|Acetaminophen oxycodone|1 tablet(Acetaminophen 325mg oxycodone 5mg), Q6h orally take,last from admission to hospital to one week after operation.
16175187|NCT01583647|Drug|MK-0524A|1 tablet of MK-0524A (1g ER niacin/20mg laropripant) orally
16175188|NCT01583647|Drug|MK-0524A|2 tablets of MK-0524A (1g ER niacin/20mg laropripant) orally
16175189|NCT01583634|Device|Mespere Oximeter|Mespere oximeter provides non-invasive venous blood oxygen saturation.
16175190|NCT01583634|Device|Radiometer OSM-3 Co-Oximeter|OSM-3, a Radiometer manufactured hemoximeter, is intended for the photometric determination of hemoglobin.
16175191|NCT01583621|Dietary Supplement|Cholecalciferol|The participants will be randomized into one of the four groups. Group 0 will be placebo group, group 1 will receive monthly supervised dose of 18,000 IU (equivalent to 600 IU/day), group 2 will receive monthly supervised dose of 60,000 IU(equivalent to 2000 IU/day), and group 3 will receive 120,000 IU (equivalent to 4000 IU/day) vitamin D3 supplementation for 4 months (16 weeks).
16175192|NCT01583582|Dietary Supplement|Marealis Refined Peptide Concentrate|1200 mg per os, once a day, 8 weeks
16175193|NCT01583582|Dietary Supplement|Marealis Refined Peptide Concentrate|600 mg per os, twice a day, 8 weeks
16175194|NCT01583582|Dietary Supplement|Marealis Refined Peptide Concentrate|0 mg per os, daily, 8 weeks
16175195|NCT01583543|Drug|Olaparib|400mg PO BID Continuous
16175196|NCT01583530|Biological|Single Dose Group: Belimumab IV 240 mg|Belimumab IV 240 mg administered on Day 0
16175197|NCT01583530|Biological|Single Dose Group: Belimumab SC 2 x 120 mg|Belimumab SC 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Day 0
16175198|NCT01583530|Biological|Single Dose Group: Belimumab SC 1 x 240 mg|Belimumab SC 240 mg x 1 injection on Day 0
16175199|NCT01583530|Biological|Single Dose Group: Belimumab SC 1 x 200 mg|Belimumab SC 200 mg x 1 injection on Day 0
16175200|NCT01583530|Biological|Multiple Dose Group: Belimumab SC 2 x 120 mg weekly|Belimumab 120 mg x 2 injections (equal to 240 mg) administered immediately one after the other on Days 0, 7, 14, and 21
16175201|NCT01583530|Biological|Multiple Dose Group: Belimumab SC 1 x 200 mg weekly|Belimumab 200 mg x 1 injection administered on Days 0, 7, 14, and 21
16175202|NCT01583517|Procedure|Biliary sphincterotomy|Cutting of the biliary sphincter muscle.
16175203|NCT01583517|Procedure|Pancreatobiliary sphincterotomy|Cutting of both the biliary and pancreatic sphincter muscles.
16175204|NCT01583517|Procedure|Sham|No sphincterotomy is performed in patients randomized to sham with normal SOM.
16175205|NCT01583504|Procedure|Ultrasound guided injection of steroid and local anaesthetic|2mls of 0.5% Bupivocaine and 25mg of hydrocortisone given as a single bolus via a 21G needle using sterile technique. The injection will be placed into the space between Kagers fat pad and the anterior aspect of the achilles tendon, into the area of maximal neovascularisation as seen on ultrasound scan.
16175206|NCT01583504|Procedure|High volume saline injection|After steroid and local anaesthetic has been delivered, a bolus of normal saline will also be infused into the space between Kager's fat pad and the achilles tendon through the same needle, using ultrasound guidance and sterile technique. At least 14mls will be given but up to 40mls could be used. Saline will be injected until the injector determines that the appearance of neovascularisation on ultrasound has disappeared.
16175207|NCT01583504|Behavioral|exercise programme|a bandage will be placed on the ankle for 48 hours and instructions given to rest the ankle. The patient will be verbally shown a programme of exercises to be done over the next 6 weeks to stretch the tendon and steadily build up load bearing on it. The exercises are also clearly shown on a leaflet which the patient takes home.
16175208|NCT01583491|Procedure|autologous platlet rich fibrin|one dose immediate after surgery
16175209|NCT01583491|Procedure|one side in control group|control group insert any things after surgery
16175210|NCT01583478|Biological|incobotulinumtoxinA|Eligible patients will receive Xeomin® doses of 20-, 40-, 60-, 80- or 100-units divided among 5 injection points (0.25 mL total) in the glabellar region on Day 0 of the study.
16175211|NCT01583465|Device|Aquamantys|Primary THA via the ASI approach will be performed using the Aquamantys Malleable Bipolar Sealer. The Aquamantys is a bipolar device that combines radio-frequency energy and saline to gently reach targeted tissue and provide a biomechanical seal. The saline acts as a conduit to allow the energy to penetrate the tissue from 1 to 2 mm where the collagen is transformed thus providing the seal. The saline also helps cool the tissue which allows for gentle handling of tissue, eliminating the black char that is a port for infection. The surgeon uses the Aquamantys to assist in tissue dissection, cauterize vessels, and to pre-treat fat pad in front of capsule prior to excision, to treat the entire anterior hip capsule prior to excision, treat oozing bone surfaces not covered by an implant.
16175212|NCT01583465|Device|standard electrocautery (Bovie)|Primary total hip arthroplasty via an anterior supine intermuscular approach will be performed with the assistance of standard electrocautery. The electrocautery is used in tissue dissection and to cauterize bleeding vessels.
16175213|NCT01583452|Other|Chewing Gum|The use of chewing gum as a preventive measure for post-operative ileus
16175214|NCT01583439|Drug|highly active antiretroviral therapy: Lopinavir/Ritonavir, Lamivudine, Zidovudine, Efavirenz, Tenofovir Disoproxil Fumarate, Emtricitabine|Atripla: one tablet administered orally once daily at bedtime, each tablet comprised of co-formulated: Efavirenz (EFV) 600mg, Emtricitabine (FTC) 200mg, Tenofovir disoproxil fumarate (TDF) 300mg(EFV/FTC/TDF). Note: the study will generally provide the fixed-dose combination Atripla, but it will also be permissible for the same drugs to be used at the same doses as individual components (or as Truvada, coformulated TDF/FTC). Other drug substitutions may be made per the protocol.
16175215|NCT01583426|Drug|nab-Paclitaxel|nab-Paclitaxel 125 mg/m² weekly for 12 weeks
16175216|NCT01583426|Drug|Paclitaxel|Paclitaxel 80 mg/m² weekly for 12 weeks
16175217|NCT01583413|Procedure|Daily SAT & SBT|Nurse and/or respiratory therapist led daily awakenings from sedation (spontaneous awakening trial, or SAT) and daily performance of a spontaneous breathing trial (SBT) among mechanically ventilated, critically ill patients in participating ICUs.
16175218|NCT01583400|Other|RESPECT-D|The RESPECT-D (Re-engineering Systems of Primary Care Treatment of Depression) intervention is a systematic approach to the assessment and management of depression within Primary Care. The essential components of the Collaborative Care model include prepared PCPs and practices, the Care Manager, and a Behavioral Health specialist all working in partnership with the patient. The trained depression care manager closely coordinates with primary care clinicians, supports treatment recommendations, patient education, appropriate follow-up to ensure adequate treatment, and coordination with a consulting psychiatrist.
16175219|NCT01583400|Other|RESPECT-D-E (Enhanced)|The RESPECT-D-E intervention includes all of the components of the RESPECT-D model, but also incorporates the enhanced digital health coaching program for depressive symptoms tool, is an on-line program with education, coaching, self-management techniques, symptom, side effect and medication adherence tracking for depression. Depressive symptoms, medication side effects and adherence data are automatically delivered to the Care Manager for use in treatment planning. The program provides tailored feedback, provides coaching on skills related to depression treatment (such as changing negative thoughts and avoiding relapse), and offers tools for tracking behavior change.
16175220|NCT01583387|Other|1-Increased water intake regimen|Arm 1-Intervention
16175221|NCT01583387|Other|2-Non-modified water intake regimen|Arm 2-Control
16175222|NCT01583374|Drug|Apremilast tablet 20 mg|Apremilast 20 mg was taken orally twice a day (BID)
16175223|NCT01583374|Drug|Apremilast tablet 30 mg BID|Apremilast 30 mg was taken orally twice a day
16175224|NCT01583374|Drug|Placebo|Identically matched placebo tablets were taken orally twice a day during the placebo controlled phase.
16175225|NCT01583361|Drug|Oxaliplatin+S-1|S-1: 40~60mg bid，po, d1~14 （S-1：BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid） oxaliplatin：130mg/m2，iv drip for 2h，d1
16175226|NCT01583361|Drug|Adjuvant Oxaliplatin/S-1（SOX）|S-1：40~60mg bid，d1~14 q3W oxaliplatin：130mg/m2，iv drip for 2h，d1,q3W 8 cycles (6 months)
16175227|NCT01583348|Procedure|Cholangiography during transvaginal rigid-hybdrid NOTES cholecystectomy|During transvaginal rigid-hybrid NOTES cholecystectomy a intraoperative cholangiography is performed. After dissection of the Calot's triangle and distal clipping of the cystic duct, the cystic duct is incised and a regular cholangiography catheter is inserted. Contrast is injected and an image is obtained using an image-converter. After extraction of the catheter the cystic duct is clipped proximally. This intervention is performed in all patients included in the study.
16175228|NCT01583335|Behavioral|Lifestyle habits, including sleep and stress|The intervention group was offered up to 10 individual consultations focusing on improving diet, physical activity and sleep habits and reducing stress. Moreover, the intervention group was offered participation in monthly cooking classes and playing arrangements
16175264|NCT01583075|Procedure|Circumferential pulmonary vein ablation|Circumferential pulmonary vein ablation
16178389|NCT01559259|Drug|Placebo|Two caplets of placebo
16175229|NCT01583322|Drug|vargatef|"400 mg (200 mg twice daily) Route of administration= oral Twice daily (to be swallowed unchewed with a glass of water of about 250 mL. If taken twice the dose interval should be of around 12 hours at the same times every day, usually in the morning and the evening after food intake).
~Continuous daily dosing until progression of disease or until criteria for interruption of treatment are met, no intake of Vargatef® (Nintedanib) on days of paclitaxel and carboplatin administration. The maximum time on monotherapy is 2 years."
16175230|NCT01583322|Drug|placebo|"Contains 0 mg of Vargatef® (Nintedanib) in capsules matching 100 mg and 150 mg of Vargatef® (Nintedanib) Route of administration: oral Twice daily (to be swallowed unchewed with a glass of water of about 250 mL. If taken twice the dose interval should be of around 12 hours at the same times every day, usually in the morning and the evening after food intake).
~Continuous daily dosing until progression of disease or until criteria for interruption of treatment is met, no intake of placebo on days of paclitaxel and carboplatin administration.
~The maximum time on monotherapy is 2 years."
16175231|NCT01583309|Procedure|online pre-dilution hemofiltration|Online pre-dilution hemofiltration was performed with a synthetic high-flux membrane and an infusate/blood flow ratio of one
16175232|NCT01583309|Procedure|online pre-dilution hemodiafiltration|Online pre-dilution hemodiafiltration was performed with a synthetic high-flux membrane with an infusate/blood flow ratio of 0.6 and a dialysate plus infusate rate of 700 ml/min.
16175233|NCT01583296|Behavioral|Music Relaxation Therapy (MRT)|music relaxation therapy and breathing at resting respiration rate
16175234|NCT01583296|Behavioral|CBT and HRVB|cognitive behavioral therapy and heart rate variability biofeedback
16175235|NCT01583283|Drug|ACY-1215|Dose escalation up to 480 mg administered orally on Days 1-5, 8-12 and 15-19 of a 28 day dosing schedule.
16175236|NCT01583283|Drug|lenalidomide|Dosed on Days 1-21 of a 28 day cycle.
16175237|NCT01583283|Drug|Dexamethasone|Dosed on Days 1, 8, 15 and 22 of a 28 day treatment cycle.
16175238|NCT01583270|Dietary Supplement|Arabinoxylan|Porridge rich in arabinoxylan
16175239|NCT01583270|Dietary Supplement|Rye kernel|Porridge made of rye kernels
16175240|NCT01583270|Dietary Supplement|Arabinoxylan and rye kernels|Porridgde made of rye kernels and arabinoxylan
16175241|NCT01583270|Dietary Supplement|Semolina|Semoline porridge. control meal.
16175242|NCT01583257|Behavioral|Workout based on active video gaming|A personalized workout regimen will be provided using the Microsoft Kinect Active Gaming Console with EA Sports Active 2 program
16175243|NCT01583244|Drug|No Intervention (subjects were previously treated with Orencia®)|No Intervention
16175244|NCT01583231|Other|Prewash|The intervention will be the addition of the prewash utilizing non-antimicrobial soap and water.
16175245|NCT01583218|Drug|Betrixaban|"Betrixaban 80 mg PO once daily (QD) for 35 day + 7 days.
~Enoxaparin Placebo: Once daily, 6-14 days"
16175246|NCT01583218|Drug|Enoxaparin|"Enoxaparin 40 mg subcutaneous (SC) QD for 10 ± 4 days.
~Betrixaban Placebo: once daily, 35 days"
16175247|NCT01583205|Behavioral|Coping Effectiveness Training - ALS|Eight coping effectiveness training counseling sessions.
16175248|NCT01583192|Procedure|skin preparation|skin preparation while be done either with chloride-hexidine 0,5% soluted in alcohol 70% or povidine-jodine 1% soluted in alcohol 70%
16175249|NCT01583179|Drug|Buprenorphine|added to nerve block, 0.3mg one time peripheral block use
16175250|NCT01583166|Drug|Bupivacaine|10ml 0.5% bupivacaine
16175251|NCT01583166|Drug|Saline|10ml 0.9% sodium chloride
16175252|NCT01583166|Drug|Epinephrine|1:200,000 epinephrine
16175253|NCT01583153|Other|Hospital Inpatient Rehabilitation|Those allocated to HI will be admitted to the adjacent rehabilitation hospital, Braeside Rehabilitation Hospital, for 10 days. As per the private sector, HI participants will receive twice-daily supervised physiotherapy comprising 1-1.5 hr class-based exercises and 1-1.5 hr one-to-one therapy. Prior to discharge, participants will be familiarised with the home programme as described in second arm. All participants will be required to complete a diary detailing programme adherence, healthcare utilisation, and social costs relating to carer-burden. Participants will attend the group-based sessions as per HO below for monitoring and progression of programme. An additional FIM outcome measure will be taken for this arm on admission and discharge from the inpatient rehab unit.
16175254|NCT01583153|Other|Hybrid Home Programme (HO)|The HO will be based on what is standard care in the local health district and guidelines for exercise in the elderly and those with osteoarthritis. Approximately 2 weeks post-surgery, participants allocated to the HO will attend 1 group-based exercise session in the Physiotherapy Department (Fairfield Hospital) where the home programme will be rehearsed and exercises individualised as required due to co-morbidities. The programme comprises general aerobic components as well as general functional and muscle-specific exercises focused on restoring knee mobility, lower limb strength, and normal neuromuscular co-ordination and gait patterns. Participants will be able to return for 2-3 sessions over the 6-week period.
16175255|NCT01583140|Behavioral|Wellness control|Participants in the Wellness Control arm of the study receive a variety of print materials focused on general health topics.
16175256|NCT01583140|Behavioral|Physical Activity Intervention|Participants in the Physical Activity Intervention arm of the study receive culturally-modified, individually tailored physical activity print materials.
16175257|NCT01583127|Behavioral|Positive Behavioral Interventions & Supports|Implementation of the School-Wide Positive Behavioral Interventions and Supports model across 4 school years.
16175258|NCT01583114|Drug|perindopril|form:1 tablet contained 5 mg of perindopril; posology: 1 intake per day, initiated at a dose of 2.5 mg (1/2 tablet) per day during one week, then 5 mg (1 tablet) per day during two weeks, then 10 mg (2 tablets), or the maximal dose tolerated, until the end of the study (36 months).
16175259|NCT01583114|Drug|placebo|form:1 tablet contained 5 mg placebo; posology: 1 intake per day, initiated at a dose of 2.5 mg (1/2 tablet) per day during one week, then 5 mg (1 tablet) per day during two weeks, then 10 mg (2 tablets), or the maximal dose tolerated, until the end of the study (36 months).
16175260|NCT01583101|Other|Receiving Highlighted Prompts|Prompts received by physicians were highlighted.
16175261|NCT01583101|Other|Receiving Non-highlighted Prompts|Prompts received by physicians were not highlighted.
16175262|NCT01583088|Device|phenique nerve stimulation NeurX™ (Synapse Biomedical)|phenique nerve stimulation NeurX™ (Synapse Biomedical)
16175263|NCT01583088|Device|sham phrenic nerve stimulation|sham phenic nerve stimulation
16175266|NCT01583062|Drug|Amoxicillin/clavulanic acid|Both groups receive amoxicillin/clavulanic acid 1.2 g intravenously every eight hours from admission up to 24 hours postoperatively. Group 1 then receives amoxicillin/clavulanic acid 625 mg orally every eight hours for four days.
16175267|NCT01583062|Drug|Amoxicillin plus placebo|Both groups receive amoxicillin/clavulanic acid 1.2 g intravenously every eight hours from admission up to 24 hours postoperatively. Group 2 receives oral placebo using the same schedule for the same duration as group 1.
16175268|NCT01583036|Drug|Digoxin Alone|Single administration of digoxin 0.25mg
16175269|NCT01583036|Drug|Digoxin + Retigabine|Increasing doses of retigabine (300mg, 450mg, 600mg, 750mg, 900mg, 1050mg and 1200mg) administered as TID doses over 44 days. Co-administration with digoxin (0.25mg) on days 10, 24 and 38.
16175270|NCT01583023|Drug|Bupropion|150mg daily for first week, 300mg daily thereafter for a total of 8 weeks
16175271|NCT01583023|Device|Active Repetitive Transcranial Magnetic Stimulation|Daily left DLPFC, at 110% motor threshold, with a frequency of 10 Hz. Stimulation will be applied in 5-second trains with a 10-second inter-train interval, for 30 trains per session. This treatment will be provided for the first 4 weeks of the study.
16175272|NCT01583023|Other|Placebo|150mg daily first week, 300mg daily thereafter for a total of 8 weeks.
16175273|NCT01583023|Device|Sham repetitive transcranial magnetic stimulation|Sham rTMS will also begin their treatment 5 times a week for 4 weeks in junction with pharmacotherapy (Wellbutrin). Sham rTMS will be delivered at a frequency of 10 Hz and stimulation will be applied in 5-second trains with a 20-second inter-train interval, for 30 trains per session.
16175274|NCT01583010|Device|ANV(R)|"Device: Advanced Needle Visualization Technology ®
~Software update for SonoSites M-Turbo® and S-series™ ultrasound systems with enhanced 15-20Mhz ultrasound probe.
~Arms: ANV ® Group"
16175275|NCT01582997|Drug|GSK2118436|Dose escalation with GSK2118436 may proceed until the overseas recommended phase III dose.
16175276|NCT01582984|Other|video or education session in addition to standard consent|Video added to standard consent + handout Video + education session added to standard consent + handout
16175277|NCT01582971|Other|Reflexology|Friend/family member trained in foot reflexology protocol by certified reflexologist; friend/family member provides 4 weekly sessions to patient
16175278|NCT01582958|Procedure|Osteopathic Manipulative Treatment (OMT)|Osteopathic Manipulative Treatment (OMT) is the therapeutic application of manually guided forces by an Osteopathic physician to improve physiologic function.
16175279|NCT01582958|Other|sham omt|Hands are placed on subjects the same as omt arm but no omt is provided.
16175280|NCT01582945|Drug|Ketamine|Ketamine IV 0.5mg/kg infusion twice a week for 3 weeks as augmentation of ongoing antidepressant regimen
16175281|NCT01582932|Drug|Calcipotriene 0.005% Foam|All treatments will be administered topically twice daily (morning and evening) for 8 weeks to areas affected with psoriasis (excluding face).
16175282|NCT01582919|Other|Neuroimaging|
16175283|NCT01582893|Device|HCO1100|Dialysis
16175284|NCT01582893|Device|P210H|Dialysis
16175285|NCT01582880|Drug|Riboflavin|Used to treat donor cornea before implantation
16175286|NCT01582867|Device|ARTIS hemodialysis system|"Software versions:
~Control Product: 8.06.01KA. Study Product: 8.06.01B_HC01"
16175287|NCT01582854|Drug|Actovegin|Actovegin solution for infusion and Actovegin tablets
16175288|NCT01582854|Drug|Placebo|Actovegin placebo-matching solution for infusion and Actovegin placebo-matching tablets
16175289|NCT01582841|Procedure|MSI screening test|All individuals in the intervention arm who consent to participate in the HNPCC screening will have their tumors evaluated for MSI.
16175290|NCT01582828|Procedure|Epicardial (surgical) ablation|"Pulmonary vein isolation with bipolar clamps and bipolar box lesion
~Epicardial atrial appendage closure"
16175291|NCT01582828|Procedure|Hybrid|"Epicardial (surgical) ablation
~Pulmonary vein isolation with bipolar clamps and bipolar box lesion
~Epicardial atrial appendage closure
~Endocardial assessment after 6-8 weeks, checking for isolation and if necessary touch up by RF ablation"
16175292|NCT01582815|Drug|JNJ-40411813|Type= range, unit= mg, number= 25 to 150, form= capsules, route= oral administration. JNJ-40411813 will be administered twice daily during 8 weeks, following fixed and flexible schedules in which the dose can range from 25 mg to 150 mg.
16175293|NCT01582815|Drug|Placebo|Form= capsule, route= oral administration. Matching placebo will be administered twice daily during 8 weeks.
16175294|NCT01582789|Device|enfilcon A|enfilcon A daily wear soft contact lens
16175295|NCT01582789|Device|senofilcon A|senofilcon A daily wear soft contact lens
16175296|NCT01582776|Drug|Lenalidomide and GA101|1000mg of GA101 on D8, D15 and D22of cycle 1 and on D1 of cycles 2 to 6. Oral lenalidomide once daily at 10/15/20/25mg (phase I part) or at recommended dose (phase II part) on days 1 to 21 of a 28-day cycle for the first cycle and on days 2 to 22 of a 28-day cycle for cycles 2 to 6.
16175297|NCT01582737|Drug|Rivaroxaban(Xarelto, BAY59-7939)|Patients treated with Xarelto under practical manner
16175298|NCT01582724|Procedure|Self-care acupressure at three predefined points|Self-care acupressure, one minute for each point, starting 5 days before menstruation, once up to twice daily; when pain is present: twice daily up to five times
16175299|NCT01582711|Behavioral|Self Administered Therapy (SAT)|Self Administered Therapy (SAT)
16175300|NCT01582711|Behavioral|SMS reminders|Short Message Service (SMS) text reminders
16175301|NCT01582711|Drug|isoniazid and rifapentine|rifapentine (PRIFTIN, RPT) 900 mg and isoniazid (INH) 900mg, once-weekly, for 12 weeks (12 doses)
16175302|NCT01582698|Biological|FSME-IMMUN 0.5 ml|Solution/suspension for injection (intramuscular injection into the deltoid muscle of the right or left upper arm). Dosage frequency of booster vaccination: dependent on serum TBE antibodies.
16175303|NCT01582685|Behavioral|Exercise|The participant will exercise for 16 weeks under supervision. The exercise regimen is increased slowly over 16 weeks.
16175304|NCT01582672|Drug|Standard Treatment|Standard treatment for Renal Cell Carcinoma
16175305|NCT01582672|Biological|AGS-003|Autologous Dendritic Cell product. Intradermal injections; 8 injections in the 1st year followed by quarterly boosters.
16175306|NCT01582659|Other|Telephone counseling|2 planned telephone counseling sessions are conducted.
16175307|NCT01582659|Other|Web access|Access to a web site with information about childhood constipation similar to the information given at the first visit to the clinic.
16175308|NCT01582646|Drug|Terbutaline sustained release 5 mg|Terbutaline 10mg oral per day (5 mg twice a day) during 28 days
16175309|NCT01582633|Biological|2012 trivalent influenza vaccine|"2012 trivalent influenza vaccine:
~influenza A/California/7/2009 (H1N1)
~influenza A/Perth/16/2009 (H3N2)
~influenza B/Brisbane/60/2008 Single dose."
16175310|NCT01582620|Procedure|Telestroke|remote videoconference consultations
16175311|NCT01582607|Drug|Bupivacaine plain|2.0 mL (10mg) plain bupivacaine hydrochloride 0.5% intrathecally
16175312|NCT01582607|Drug|Ropivacaine plain|2.0 ml (15mg) plain ropivacaine 0.75% intrathecally
16175313|NCT01582607|Drug|Levobupivacaine plain|2.0 ml (10mg) plain levo-bupivacaine hydrochloride 0.5% intrathecally
16175314|NCT01582607|Drug|bupivacaine plain +fentanyl|2.0 ml (10mg) plain bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl intrathecally
16175315|NCT01582607|Drug|ropivacaine plain +. fentanyl|2.0 ml (15mg) plain ropivacaine 0.75% with 0.2 ml (10 μg) fentanyl intrathecally
16175316|NCT01582607|Drug|Levobupivacaine plain +fentanyl|2.0 ml (10mg) plain levo-bupivacaine 0.5% with 0.2 ml (10 μg) fentanyl intrathecally
16175317|NCT01582581|Behavioral|Telephonic CBT|Cognitive behavioral therapy, guided by computer, using the TAD protocol for treatment of Adolescent Depression, modified for delivery by a nurse or master's level clinician over the telephone in 15-18 sessions lasting 30-45 minutes at weekly intervals. Includes regular and standardized weekly monitoring by the treating clinician of depressive symptoms and factors affecting suicide risk.
16175318|NCT01582581|Behavioral|Wait List Control|Wait list control with measurement of key outcomes at baseline (week 0), and then weeks 3 and 5.
16175319|NCT01582568|Drug|Certolizumab|Certolizumab 200mg-400mg subcutaneous every 2 weeks for 8 weeks.
16175320|NCT01582555|Drug|saline nasal irrigation alone|control arm (group A) of generic saline irrigation alone, irrigating with 20 mL per nostril tid for a total of 120 mL daily irrigation
16175321|NCT01582555|Drug|dissolved N-Acetylcystine|intervention arm (group B), which included generic N-Acetylcystine of 200 mg dissolved in 200 mL saline irrigated as per group A, 20 mL per nostril given tid daily (for a total of 120 mg).
16175322|NCT01582542|Drug|Desmopressin|"Patients after radical cystectomy with orthotopic bladder reconstruction that suffer from night time urinary incontinence will be enrolled in the study. They will be given for a period of one month after informed consent, Desmopressin At a dosage of 0.1 MG per day. The rate of improvement of night time urinary incontinence will be measured."
16175323|NCT01582516|Biological|delta-24-RGD adenovirus|slow continuous microinfusion in and around the brain tumor during 44 hrs.by 4 temporary placed catheters
16175324|NCT01582503|Drug|MEMP1972A|Subcutaneous repeating dose
16175325|NCT01582503|Drug|MEMP1972A|Subcutaneous repeating dose
16175326|NCT01582503|Drug|MEMP1972A|Subcutaneous repeating dose
16175327|NCT01582503|Drug|placebo|Subcutaneous repeating dose
16175328|NCT01582490|Drug|Instillation - EXPAREL|Intravenous (IV) morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.
16175329|NCT01582490|Drug|Infiltration - EXPAREL|IV morphine sulfate, hydromorphone, or oral oxycodone with acetaminophen (5/325 mg) will be permitted following surgery, as needed.
16175330|NCT01582477|Drug|EXPAREL 20 mL|EXPAREL 266 mg (undiluted)
16175331|NCT01582477|Drug|EXPAREL 40 mL|EXPAREL 266 mg diluted with preservative-free 0.9% normal saline to 40 mL.
16175332|NCT01582464|Behavioral|Social Marketing for protective headgear|"Social marketing was done using a CQI manner after each focus group with experts and with seniors using a structured interview approach with an iterative process to develop a progressive method of presenting information about head injuries and their input on a new prevention.
~To measure changes in attitudes, the participants were given an attitudes questionnaire (PHAQ), & a demographic & functional status questionnaire. Input into the social marketing content was sought in a structured interview manner, and by using an audience response system with questions projected by power point. At the conclusion of the social marketing, the PHAQ was repeated and sent to participants 2 weeks after the focus group to gage stability of changes in attitudes."
16175333|NCT01582451|Drug|LY2605541|
16175334|NCT01582451|Drug|Insulin glargine|
16175335|NCT01582438|Drug|Access program - sildenafil citrate, Viagra, Revatio|The recommended dose is 20 mg TID for subjects with body weight > 20 kg and 10 mg TID for subjects with body weight ≤ 20 kg. If subject is 18 years of age or older, the recommended dose is 20 mg TID, regardless of body weight. If a subject was receiving a higher dose in study A1481156 and the investigator believes that the subject requires continued treatment on that dose, or if dose reduction is judged to be associated with pulmonary arterial hypertension (PAH) deterioration in a particular subject, the higher dose may be made available, as judged on an individual basis on discussion with the sponsor.
16175336|NCT01582425|Drug|Isavuconazole|oral
16175337|NCT01582425|Drug|Methadone|oral
16175338|NCT01582412|Drug|Isavuconazole|oral
16175339|NCT01582412|Drug|digoxin|oral
16175340|NCT01582399|Drug|ASKP1240|intravenous(IV) infusion and subcutaneous (SC)
16175341|NCT01582373|Behavioral|Cognitive-behavioral couple therapy|The treatment package will include the following: information about the nature of CBCT; education about PVD and how it impacts on sexuality; education concerning a multifactorial view of pain; relaxation techniques; vaginal dilatation exercises; cognitive restructuring exercises (replacing distorted or irrational beliefs about pain and sexuality by more realistic ones); distraction techniques focusing on sexual imagery; expansion of the sexual repertoire; and exercises to improve pain and sexuality-relevant couple interactions (e.g., communication skills training, modification of maladaptive partner responses to pain, emotional disclosure and validation exercises).
16175342|NCT01582347|Drug|RBP-6300|"Participants randomized to the RBP-6300 treatment arm take either 10, 20 or 30 mg/day RBP-6300 tablets during the Transfer Period (study days 1-7).
~Oral RBP-6300 tablets containing 10 mg buprenorphine hemiadipate HCl and 10 mg naloxone HCl dehydrate."
16175343|NCT01582347|Drug|Subutex®/Suboxone®|"Participants randomized to the Subutex®/Suboxone® treatment arm take the dosage of either drug on which they were previously stabilised during the Run-In, Transfer, and Transition Periods.
~Participants randomized to the RBP-6300 treatment arm take the dosage of either drug on which they were previously stabilised during the Run-In and Transition Periods.
~Sublingual Subutex® tablets containing 8 mg buprenorphine and and sublingual Suboxone® tablets containing 8 mg buprenorphine and 2 mg naloxone."
16175344|NCT01582347|Drug|Placebo for RBP-6300|"Participants randomized to the Subutex®/Suboxone® treatment arm take Placebo for RBP-6300 during the Transfer and Transition Periods.
~Participants randomized to the RBP-6300 treatment arm take Placebo for RBP-6300 during the Transition Period."
16175345|NCT01582347|Drug|Placebo for Subutex®/Suboxone®|Participants randomized to the RBP-6300 treatment arm take Placebo for Subutex®/Suboxone® during the Transfer Period.
16175346|NCT01582334|Device|easypod™|Saizen (Somatropin) as per Summary of Product Characteristics administered by easypod™
16175347|NCT01582321|Biological|Typhoid vaccine|The typhoid vaccine is composed of purified polysaccharide from S. typhi capsule 25 micrograms contained in 0.5 ml solution
16175348|NCT01582321|Drug|Cantharidin|0.1% cantharidin solution in acetone from 0.7% stock solution of cantharone is prepared and applied immediately. 10 μl of cantharidin per disc.
16175349|NCT01582308|Drug|Sitagliptin 100 mg|Sitagliptin 100 mg: one sitagliptin 100 mg tablet once daily in the morning following a fast of at least approximately 8 hours on Days 1 through 5 in one out of five treatment periods.
16175350|NCT01582308|Drug|Saxagliptin 5 mg|Saxagliptin 5 mg: one saxagliptin 5 mg tablet once daily in the morning following a fast of at least approximately 8 hours on Days 1 through 5 in one out of five treatment periods.
16175351|NCT01582308|Drug|Vildagliptin 50 mg|Vildagliptin 50 mg: one vildagliptin 50 mg tablet once daily in the morning following a fast of at least approximately 8 hours on Days 1 through 5 in one out of five treatment periods.
16175352|NCT01582308|Drug|Vildagliptin 50 mg BID|Vildagliptin 50 mg BID: one vildagliptin 50 mg tablet BID (twice daily), once in the morning following a fast of at least approximately 8 hours and once in the evening on Days 1 through 5 in one out of five treatment periods.
16175353|NCT01582308|Drug|Placebo|Placebo: one placebo for sitagliptin tablet once daily in the morning following a fast of at least approximately 8 hours on Days 1 through 5 in one out of five treatment periods.
16175354|NCT01582295|Drug|Cabozantinib|Starting dose 40 mg daily
16175355|NCT01582282|Dietary Supplement|placebo|fiber-free placebo
16175356|NCT01582282|Dietary Supplement|3.4 g psyllium BID|3.4 g psyllium BID for a total of 6.8 g/day (10.4g Metamucil)
16175357|NCT01582282|Dietary Supplement|6.8g psyllium BID|6.8g psyllium BID for a total of 13.6 g/day (20.8g Metamucil)
16175358|NCT01582269|Drug|LY2157299 monohydrate|Orally administered as tablets
16175359|NCT01582269|Drug|Lomustine|Orally administered as capsules
16175360|NCT01582269|Drug|Placebo|Orally administered as tablets
16175361|NCT01582243|Drug|Vildagliptin|Vildagliptin 50 mg plus metformin 500 mg as Single Pill combination (SPC)
16175362|NCT01582230|Drug|Vildagliptin|Patient will receive vildagliptin 50mg twice daily (bid) in addition to their stable dose of insulin with or without metformin for 24 weeks
16175363|NCT01582230|Drug|Placebo|Patient will receive matching placebo to vildagliptin in addition to their stable dose of insulin with or without metformin for 24 weeks
16175364|NCT01582204|Drug|124IcG250|Pts will undergo baseline disease assessment with CT scans (chest, abd & pelvis), 124I-cG250-PET/CT & Tc99mMDP bone scan. W/I 7 days of their lst 124I-cG250 PET/CT, pts will start tx with sunitinib or pazopanib, dosed in successive 6-week cycles. At selected time points during the sunitinib or pazopanib cycle 1, repeat imaging with CT scan & 124I-cG250 PET/CT will be performed. After cycle 2, pts will be followed per standard of care, i.e., pts will have a standard CT scan of the chest, abd, & pelvis with contrast after cycles 2, 3, 4 & 6 (or at the time of disease progression if prior to cycle 6) for determination of best response using RECIST 1.1. Each pt will have 2 124I-cG250-PET/CT scans: baseline & week 4 (during sunitinib or pazopanib tx). All experimental imaging will take place during tx cycle 1. There will be a dosimetry sub-study for pts willing to undergo 3 additional PET/CT scans, whole body counts, & serial blood sampling, following the lst inj of 124I-cG250.
16175365|NCT01582191|Drug|Everolimus|Given PO
16175366|NCT01582191|Other|Laboratory Biomarker Analysis|Optional correlative studies
16175367|NCT01582191|Other|Pharmacological Study|Optional correlative studies
16175368|NCT01582191|Drug|Vandetanib|Given PO
16175369|NCT01582178|Procedure|Warm Water Immersion Colonoscopy|Colonoscopy using warm water (37°C) infusion for colonoscope insertion and room air insufflation during colonoscope withdrawal.
16175370|NCT01582178|Procedure|Cool Water Immersion Colonoscopy|Colonoscopy using room temperature water (20-24°C) infusion for colonoscope insertion and room air insufflation during colonoscope withdrawal.
16175371|NCT01582165|Drug|Rosuvastatin|Rosuvastatin 20 mg once daily vs placebo for 6 months
16175372|NCT01582165|Drug|Placebo.|Placebo once daily vs rosuvastatin for 6 months
16175373|NCT01582152|Drug|TPI287|"Phase I Starting Dose: 160 mg/m2 given by vein on Day 1 every three weeks of a 42 Day cycle.
~Phase II Starting Dose: Maximum Tolerated Dose (MTD) from Phase I."
16175374|NCT01582152|Drug|Bevacizumab|Arm A + B: 10 mg/kg by vein every 2 weeks of a 42 day cycle.
16175375|NCT01582139|Device|Heart rate informed SSM+HMM|The Safety Supervision Module + Hyperglycemic Mitigation Module (SSM+HMM) of the Closed Loop is informed about heart rate during exercise. The goal is to demonstrate the feasibility of a modular insulin management system based on continuous glucose monitoring that additionally employs heart rate information to reduce exercise-related hypoglycemic episodes.
16175376|NCT01582126|Other|Group balance training|Balance training i group with focus on core stability exercises and dual attention activities.
16175377|NCT01582113|Drug|Citicoline|Participants randomly assigned to the experimental group, who, in addition to the research staff will be blind to such assignment, will be instructed to orally administer 500 mg or 250 mg daily citicoline. These participants will receive a 14-day supply of citicoline at visit 1 and again at visit 2, making for a 28-day administration period.
16175378|NCT01582113|Other|Microcrystalline Cellulose|Microcrystalline Cellulose will be the placebo administered to participants randomly assigned to the placebo arm. Microcrystalline Cellulose will serve as the placebo for Citicoline and will be orally administered daily in 470 mg doses.
16175379|NCT01582100|Device|Reletex|Neuromodulation device worn on the wrist
16175380|NCT01582061|Drug|Pasireotide sub-cutaneous|Pasireotide sub-cutaneous was supplied in 1 ml ampoules containing 900 μg, 600 μg, or 300 μg pasireotide per 1 ml of solution and was administered BID. Starting dose was 900 μg and 600 μg for glucose impaired metabolism patients
16175425|NCT01581788|Drug|Divalproex Sodium|Divalproex Sodium ER Tablets, 500 mg
16175381|NCT01582048|Drug|immunosuppression|Conditioning with treosulfan 14 g/m2 day -6 to -4, fludarabine 30 mg/m2/24h day-6 to -2, ATG-Fresenius 20 mg/kg day -4 to -2, rituximab 500 mg/m2 day -1. Unmanipulated PBSC day 0. Postgrafting immunosuppression with mycophenolate mofetil (15 mg/kg TID) and sirolimus (2 mg QD).
16175382|NCT01582035|Drug|TMC647055|type=exact number, unit=mg, number=500, form=solution, route=oral use. Panel 1: TMC647055 is to be taken twice daily at a dose of 500 mg per day for 10 days.
16175383|NCT01582035|Drug|TMC647055|type=exact number, unit= mg, number=up to macimum 1000, form=solution, route=oral use. Panel 2: TMC647055 is to be taken twice daily at a maximum dose of 1000 mg for 10 or 14 days.
16175384|NCT01582035|Drug|TVR|type=exact number, unit= mg, number=1125, form=tablet, route=oral use. TVR is to be taken twice daily at a dose of 1125 mg for 10 days.
16175385|NCT01582035|Drug|TVR|type=exact number, unit=mg, number=1125 or 1500, form=tablet, route=oral use. In panel 2: TVR is to be taken twice daily at a dose of 1125 or 1500 mg for 10 or 14 days. In panel 3: TVR is to be taken twice daily at a dose of 1125 or 1500 mg for 6 days with on day 6 a morning dose only.
16175386|NCT01582035|Drug|TVR|type= exact number, unit= mg, number=750, form=tablet, route=oral use. TVR is to be taken every 8 hours at a dose of 750 mg for 12 weeks.
16175387|NCT01582035|Drug|PegFN|type= exact number, unit= mcg, number=180, form=solution, route=subcutaneous. PegIFN is to be injected once per week for 24 or 48 weeks.
16175388|NCT01582035|Drug|RBV|type=exact number, unit=mg, number=1000 or 1200, form=tablet, route=oral use. RBV is to be taken at 1000 or 1200 mg per day in 2 divided doses, depending on the weight for 24 or 48 weeks.
16175389|NCT01582022|Drug|Bupivacaine|local application for 5 minutes
16175390|NCT01582022|Drug|normal saline|local application for 5 minutes
16175391|NCT01582009|Drug|panobinostat|Given orally
16175392|NCT01582009|Drug|everolimus|Given orally
16175393|NCT01582009|Other|laboratory biomarker analysis|Correlative studies
16175394|NCT01582009|Other|pharmacological study|Correlative studies
16175395|NCT01582009|Other|liquid chromatography|Correlative studies
16175396|NCT01582009|Other|mass spectrometry|Correlative studies
16175397|NCT01582009|Other|enzyme-linked immunosorbent assay|Correlative studies
16175398|NCT01582009|Other|immunohistochemistry staining method|Correlative studies
16175399|NCT01581996|Drug|lanthanum carbonate|All patients will receive the following doses of lanthanum carbonate in random order for 10 -12 days each. O mg, 500 mg tid, 1000 mg tid, 1500 mg tid.
16175400|NCT01581983|Behavioral|Internet Mindfulness Meditation|one hour session each week for six weeks
16175401|NCT01581983|Behavioral|Individual Mindfulness Meditation|one hour session each week for six weeks
16175402|NCT01581970|Drug|Cyclophosphamide|Patients will be given oral cyclophosphamide 50 mg twice daily to be self-administered starting the first day of therapy with weekly cetuximab for 12 weeks or until disease progression.
16175403|NCT01581970|Drug|Cetuximab|The initial dose of cetuximab 400 mg/m^2 is administered over 120 minutes followed by weekly infusions of cetuximab 250 mg/m^2 intravenously (IV) over 60 minutes.
16175404|NCT01581957|Other|Specific Enteral Nutrition|Patients will receive a Specific EN. The caloric target is 25 Kcal/kg/day to be reached on the third day post-initiation of EN (early enteral nutrition).
16175405|NCT01581957|Other|Standard Enteral Nutrition|Patients will receive an equivalent volume and caloric intake of standard formulation. The caloric target is 25 Kcal/kg/day to be reached on the third day post-initiation of EN (early enteral nutrition).
16175406|NCT01581944|Drug|2 Doses Goserelin|3.6mg administered monthly for 2 months prior to myomectomy
16175407|NCT01581944|Drug|3 Doses Goserelin|3.6mg administered monthly for 3 months prior to myomectomy
16175408|NCT01581931|Drug|Linagliptin/metformin|FDC
16175409|NCT01581931|Drug|Metformin|single tablet Metformin
16175410|NCT01581931|Drug|Linagliptin|single tablet Linagliptin
16175411|NCT01581918|Drug|Carbamazepine|Patients will receive Carbamazepine in first chemotherapy cycle as planned: - One tablet (200mg) at night on third day before chemotherapy; - One tablet (200mg) every 12 hours on second day before chemotherapy; - One tablet (200mg) every 8 hours from the day before until fifth day after chemotherapy.
16175412|NCT01581905|Procedure|Conventional Laparoscopic Hysterectomy (LH)|Patients assigned to this intervention will undergo conventional laparoscopic hysterectomy, either total or supracervical.
16175413|NCT01581905|Procedure|Robot Assisted Hysterectomy|Patients assigned to this group will undergo Robot-Assisted Laparoscopic Hysterectomy, either total or supracervical.
16175414|NCT01581892|Procedure|Osteosynthesis|To mix the cell suspension with osteogenic matrix and to use sheet and nails in order to consolidate the fracture
16175415|NCT01581879|Drug|Ziprasidone Hydrochloride|Ziprasidone HCL Capsules, 20 mg
16175416|NCT01581866|Drug|Ziprasidone Hydrochloride|Ziprasidone HCL Capsules, 20 mg
16175417|NCT01581853|Drug|Lopinavir/ritonavir 800 mg / 200mg|Lopinavir/ritonavir 800 mg / 200mg will be change from its approved posology (2 times daily)to once daily in patients with undetectable viral load and in stable treatment with Lopinavir/ritonavir 800 mg / 200mg in monotherapy for at least 6 months
16175418|NCT01581840|Drug|radiochemotherapy|Radiotherapy : PTV1 45 Gy 5 weeks PTV2 20 Gy 2 weeks Chemotherapy : 5Fu (400 to 1000 mg/m²) mitomycin : 10 mg/m²
16175419|NCT01581840|Drug|Panitumumab|3 or 6 mg/kg (according to dose level)
16175420|NCT01581814|Drug|Metformin|500 mg of Metformin per 3/die
16175421|NCT01581814|Drug|Yasmin;|1pill/day for cycles of 28 days (21 pills followed by 7 no-pill days)
16175422|NCT01581814|Drug|Metformin plus Yasmin|0.03 mg EE plus 3 mg of DRPS combined with 500 mg of metformin three times daily
16175423|NCT01581801|Procedure|Gastric Bypass|"Roux-en-Y Gastric Bypass This laparoscopic operation includes the division of the stomach in two parts. A proximal, smaller pouch (20-25 cc volume), is connected to the rest of the gastrointestinal tract through a gastro-jejunal anastomosis, whereas the distal gastric pouch is left behind but excluded from the transit of food.
~An entero-entero anastomosis, with a Roux-en-Y type of reconstruction, allows the bile and pancreatic juices to mix with the nutrients at about 100-150 cm from the gastro-jejunal connection."
16175424|NCT01581801|Procedure|Sleeve Gastrectomy|Sleeve gastrectomy Laparoscopic SG involves a longitudinal resection of the stomach on the greater curvature from the antrum starting opposite of the nerve of Latarjet up to the angle of His The final gastric volume is about 100 mL.
16175426|NCT01581775|Drug|Divalproex Sodium|Divalproex Sodium ER Tablets, 500 mg
16175427|NCT01581762|Procedure|EUS-guided FNA|EUS-guided FNA with two types of needles - conventional 22G needle (Sham control) and Procore needle (active comparator)
16175428|NCT01581749|Radiation|"TrueBeam stereotactic body radiosurgery"|36.25Gy to be delivered to the prostate in 5 fractions. There is only 1 arm in this study.
16175429|NCT01581736|Drug|U100 Humulin|Infused at a rate of 80/mU/m2 surface area per minute one time over 2 hours
16175430|NCT01581736|Other|Exercise|Single episode of exercise riding a stationary bike.
16175431|NCT01581723|Device|Monopolar diathermy|monopolar diathermy
16175432|NCT01581723|Device|Bipolar diathermy|bipolar diathermy
16175433|NCT01581710|Drug|Montelukast to placebo|Subjects will receive montelukast (4 mg or 5 mg) Each treatment period consists of 2 weeks
16175434|NCT01581710|Drug|Placebo to montelukast|Subjects will receive matching placebo. Each treatment period consists of 2 weeks
16175435|NCT01581697|Dietary Supplement|Oat bran|
16175436|NCT01581684|Drug|BI 411034|Low dose solution for oral administration
16175437|NCT01581684|Drug|Placebo|Solution for oral administration
16175438|NCT01581684|Drug|BI 411034|Medium dose solution for oral administration
16175439|NCT01581684|Drug|BI 411034|Low dose solution for oral administration
16175440|NCT01581684|Drug|BI 411034|High dose solution for oral administration
16175441|NCT01581684|Drug|BI 411034|High dose solution for oral administration
16175442|NCT01581684|Drug|BI 411034|Medium dose solution for oral administration
16175443|NCT01581684|Drug|BI 411034|High dose solution for oral administration
16175444|NCT01581684|Drug|BI 411034|Medium dose solution for oral administration
16175445|NCT01581658|Drug|BI10773|BI10773 medium dose tablet single dose
16175446|NCT01581658|Drug|BI10773|BI10773 medium dose tablet single dose
16175447|NCT01581658|Drug|BI10773|BI10773 medium dose tablet single dose
16175448|NCT01581658|Drug|BI10773|BI10773 medium dose tablet single dose
16175449|NCT01581645|Device|Mobilaser|Patients will begin by collecting data at home without using the mobilaser. They will then be given the mobilaser to use at home for 6 weeks while they collect data on whether their gait has improved. They will then have to return the Mobilaser to the clinic and collect data at home for 3 days to see if there is a difference.
16175450|NCT01581632|Device|LipiScan/LipiScan IVUS|Evaluation of the coronary artery using near infrared spectroscopy using either a LipiScan catheter or a LipiScan/IVUS catheter following a clinically indicated coronary angiogram and endothelial function testing with a positive diagnosis of endothelial dysfunction. The procedure is repeated following 6 months of Lp-PLA2 inhibition.
16175451|NCT01581619|Radiation|External Beam Partial-Breast Irradiation|40 Gy in ten daily fractions over two weeks
16175452|NCT01581593|Biological|Kedrion IVIG 10%|Dosage form - Intravenous (IV) infusion of Kedrion IVIG 10%; Dosage - 300 to 900 mg/kg body weight (bw); Frequency - every 21 to 28 days; Treatment duration - 12 months
16175454|NCT01581541|Drug|PU-H71|PU-H71 is a synthetic HSP90 inhibitor which can bind both open and closed conformations of HSP90. It demonstrates extended tumor retention and client protein degradation, while being rapidly cleared from normal tissues. It has shown complete tumor responses and retained sensitivity to retreatment in vivo.
16175455|NCT01581528|Genetic|gene expression analysis|
16175456|NCT01581528|Other|cell culture procedure|
16175457|NCT01581528|Other|flow cytometry|
16175458|NCT01581528|Other|laboratory biomarker analysis|
16175459|NCT01581528|Other|metabolic assessment|
16175460|NCT01581515|Device|Promus Element everolimus eluting coronary stent|Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime
16175461|NCT01581515|Device|Xience Prime everolimus eluting coronary stent|Patients with native coronary arteries fulfilling all enrollment criteria will be randomly assigned to each DES group; either Promus Element or Xience Prime
16175462|NCT01581502|Other|This is an observational study.|This is an observational, not intervention, study.
16175463|NCT01581489|Procedure|Time to clamping of the umbilical cord after delivery|The time after delivery of the newborn until the midwife stops the circulation in the umbilical cord with a clamp.
16175464|NCT01581476|Drug|Statin|10mg daily for a minimum period of 2 years
16175465|NCT01581476|Drug|ACE inhibitor|Starting dose of 5mg daily rising after 14 days to 10mg daily providing it is well tolerated for a minimum period of 2 years.
16175466|NCT01581476|Drug|Placebo|Participants receive statin placebo and ACEI placebo
16175467|NCT01581476|Drug|Combination therapy|Participants receive both active statin and active ACEI. Dose for Statins is 10mg daily. Dosing for ACEI starts at 5mg daily rising to 10mg after 14 days providing it is well tolerated. Both interventions last for a minimum of 2 years.
16175468|NCT01581463|Drug|Liothyronine, Sodium|Single 100-microgram (2 X 50 microgram) dose.
16175469|NCT01581450|Drug|Nitrous Oxide|35%
16175470|NCT01581450|Drug|Nitrous Oxide|50%
16175471|NCT01581437|Procedure|64 pole basket catheter|The 64 pole basket catheter expands into a small flexible balloon that conforms to the atrial anatomy.
16175472|NCT01581411|Drug|Tissue Plasminogen Activator|Intra-ophthalmic artery injection of 2 mg t-PA over 10 minutes followed by 10 mg t-PA over 2 hours
16175473|NCT01581398|Drug|Ypeginterferon alfa-2b|sc, qw, 24 weeks.
16175474|NCT01581398|Drug|Pegasys|sc, qw, 24 weeks.
16175475|NCT01581398|Drug|Ypeginterferon alfa-2b|sc, qw, 48 weeks.
16175476|NCT01581398|Drug|Pegasys|sc, qw, 48 weeks.
16175477|NCT01581372|Other|Pharmacist care|Pharmacist prescribing, education, drug management
16175478|NCT01581359|Drug|Triptorelin acetate|"Triptorelin acetate Dosing regimen: 1 subcutaneous injection of 3,75 mg/28 days, total of 3 doses
~Placebo Dosing regimen: subcutaneous injection of the same volume of physiological serum/28 days, total of 3 doses"
16175479|NCT01581346|Other|Exercise intervention|Pts were instructed to train at least 5 times/ week in the inpatient setting. After discharge pts were instructed to train in a home-based setting at least 3 times/week for a period of 8 weeks.
16175480|NCT01581333|Drug|Empirical antimicrobial treatment discontinuation|Empirical antimicrobial treatment discontinuation will occur when the patient is: Afebrile, with resolution of signs, symptoms and test abnormalities secondary to complementary source of infection and with normalization of vital signs for ≥ 72 h.
16175481|NCT01581333|Drug|Standard empirical antimicrobial treatment discontinuation|"The empirical antimicrobial treatment discontinuation will occur when the patient is:
~The neutrophil count is above 500 million per mm3."
16175482|NCT01581320|Drug|Test group|Once a month, administration of DP-R206 & placebo for 16 weeks
16175483|NCT01581320|Drug|Reference group|Once a month, administration of Bonviva & placebo for 16 weeks
16175484|NCT01581307|Drug|FOLFOX7 (Folinic acid, 5-Fluorouracil, and Oxaliplatin)|The usual treatment if gemcitabine chemotherapy has failed is chemotherapy with a drug combination called FOLFOX (folinic acid, 5-FU and oxaliplatin) given through a vein every 2 weeks for 6-10 cycles. Participants will receive this treatment.
16175485|NCT01581307|Device|TheraSpheres|TheraSpheres are a medical device containing yttrium-90 (Y-90), a radioactive material that has been used previously in the treatment of liver tumors. Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver. TheraSpheres have restricted approval from the United States Food and Drug Administration (FDA) for the treatment of hepatocellular liver cancer; but has not yet been approved for the treatment of pancreatic cancer that has spread to the liver.
16175486|NCT01581281|Drug|Amitriptyline|Amitriptyline will be administered twice daily at home during the 8-week titration period followed by a 16 week maintenance phase of the highest tolerated dose. The morning dose is a placebo pill. Dosing of amitriptyline will be weight-based.
16175487|NCT01581281|Drug|Topiramate|Topiramate will be administered twice daily at home during the 8-week titration period followed by a 16 week maintenance phase of the highest tolerated dose. Dosing of topiramate will be weight-based.
16175488|NCT01581281|Drug|Placebo|Placebo will be administered twice daily at home during the 8-week titration period followed by a 16 week maintenance period.
16175489|NCT01581242|Drug|Clevudine, Adefovir dipivoxil , Clevudine+Adefovir dipivoxil|Clevudine 20mg qd Days 1; Adefovir dipivoxil 10 mg qd Days 8;Clevudine 20mg +Adefovir dipivoxil 10mg qd Days 15
16175490|NCT01581242|Drug|Clevudine; Adefovir dipivoxil ,Clevudine +Adefovir dipivoxil|Clevudine 20mg +Adefovir dipivoxil 10mg qd Days 1; Clevudine 20mg qd Days 8; Adefovir dipivoxil 10 mg qd Days 15;
16175491|NCT01581242|Drug|Clevudine,Adefovir dipivoxil ,Clevudine +Adefovir dipivoxil|Adefovir dipivoxil 10 mg qd Days 1;Clevudine 20mg +Adefovir dipivoxil 10mg qd Days 8; Clevudine 20mg qd Days 15
16175492|NCT01581229|Procedure|noninvasive positive pressure ventilation|Patients in the NPPV group are ventilated using the CPAP or bilevel positive airways pressure S/T mode.
16175493|NCT01581229|Procedure|oxygen therapy|In the control group, Venturi masks are used to maintain SpO2 at 92% to 96% by adjusting the oxygen flow rates.
16175494|NCT01581216|Other|10 minute walk|Patients who walk a distance ≤ 300 meters in the 6-minute walk test will make a 10 minute walk once a day for 5 days for 4 weeks in a 90-feet long corridor located at the palliative care unit.
16175495|NCT01581216|Other|20 minute walk|Patients who walk 300-450 meters in the 6-minute walk test will make a 20 minute walk once a day for 5 days for 4 weeks in a 90-feet long corridor located at the palliative care unit.
16175496|NCT01581216|Other|30 minute walk|Patients who walk a distance less than 450 meters in the 6-minute walk test will make a 30 minute walk once a day for 5 days for 4 weeks in a 90-feet long corridor located at the palliative care unit.
16175497|NCT01581203|Drug|Asunaprevir (ASV)|
16175498|NCT01581203|Drug|Daclatasvir (DCV)|
16175499|NCT01581203|Drug|Pegylated-interferon alfa 2a (PegIFN)|
16175500|NCT01581203|Drug|Ribavirin (RBV)|
16175501|NCT01581190|Dietary Supplement|Bananas versus 6% carbohydrate beverage|Trained cyclists (N=14) completed two 75-km cycling time trials (randomized, crossover) while ingesting BAN or CHO (0.2 g/kg carbohydrate every 15 min).
16175502|NCT01581177|Drug|Albuterol DPI 25 mcg/inh|Albuterol DPI with 25 mcg Albuterol/inhalation
16175503|NCT01581177|Drug|Albuterol DPI 90 mcg/inh|Albuterol DPI with 90 mcg Albuterol/inhalation
16175504|NCT01581177|Drug|Placebo DPI|Placebo DPI with 0 mcg Albuterol/inhalation
16175505|NCT01581177|Drug|Albuterol MDI 90 mcg/inh|Albuterol MDI with 90 mcg Albtuerol/inhalation
16175506|NCT01581164|Biological|Influenza vaccine|Influenza vaccine: Injection, post transplant
16175507|NCT01581164|Biological|Varicella vaccine|Varicella vaccine: Injection, post transplant
16175508|NCT01581151|Drug|Dexamethasone intravitreal implant|Patients will receive a Dexamethasone implant and ranibizumab, as needed. A comparison will be made between ranibizumab and Dexamethasone implant with rescue ranibizumab.
16175509|NCT01581151|Drug|Monthly Ranibizumab|30 days between treatments
16175510|NCT01581138|Drug|VX-222|400 mg tablets twice daily for oral administration
16175511|NCT01581138|Drug|telaprevir|1125 mg tablets twice daily for oral administration
16175512|NCT01581138|Drug|ribavirin|1000 mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing ≥75 kg, dosed twice daily
16175513|NCT01581125|Behavioral|Sleep:wake 1|Sleep and Wake durations for arm 1
16175514|NCT01581125|Behavioral|Sleep:wake 2|Sleep and Wake durations for arm2
16175515|NCT01581112|Biological|Microbial transplant|Every subjects has 2 armpits and 2 feet. One armpit/foot is treated, the other is not treated.
16175516|NCT01581099|Procedure|Digestive Adaptations III surgery|
16175517|NCT01581073|Drug|Darbepoetin alfa|Darbepoetin alfa is used for targeting Hb level of 11-13g/dL in high Hb group, and 9-11g/dL in low Hb group.
16175518|NCT01581060|Drug|WX-554|Capsules of WX-554
16175519|NCT01581034|Drug|PADMA 28|PADMA 28 is a biological drug registered in Switzerland. It contains 20 herbs from Tibet. 3 times 2 capsules per day (30min to 1h before breakfast, lunch and dinner) of PADMA 28 or placebo will be taken. One capsule contains 403mg.
16175520|NCT01581034|Drug|Placebo|3 times 2 capsules per day (30min to 1h before breakfast, lunch and dinner) of placebo will be taken. One capsule contains 403mg.
16175521|NCT01581021|Device|Pedicle screws|Screws that are placed into the pedicle of vertebral body.
16175522|NCT01581021|Device|Laminar Hooks|Hooks are placed over the lamina of the vertebral body
16175557|NCT01580722|Procedure|early reconstruction|patients underwent < 8 weeks reconstruction after injury
16175523|NCT01581008|Other|Collaborative Care to Alleviate Symptoms and Adjust to Illness|A palliative symptom management and psychosocial care intervention named Collaborative Care to Alleviate Symptoms and Adjust to Illness (CASA) that includes (a) evidence-based palliative symptom management of breathlessness, fatigue, and pain, provided by a nurse; (b) a 6-session structured psychosocial care protocol targeting depression and adjustment to illness, supplemented by informal (family) caregiver assessment and support, provided by a social worker or psychologist; and (c) brief weekly team meetings with the nurse, social worker/psychologist and a palliative care specialist, cardiologist, and primary care provider.
16175524|NCT01581008|Behavioral|Psychospiritual|A psychospiritual intervention that is home-based, self-guided, and requires minimal resources. It will be delivered in written modular form via US Mail along with brief weekly telephone support.
16175525|NCT01580995|Drug|Valacyclovir|Valacyclovir 500 mg po bid
16175526|NCT01580995|Drug|Placebo|Placebo tablet twice daily
16175527|NCT01580969|Drug|Bevacizumab|Bevacizumab will be administered in accordance with the FDA-approved dose for gliomas, 10mg/kg IV every 2 weeks. Bevacizumab will be continued every two weeks as long as tolerated. One cycle of bevacizumab will be 28 days, with treatments on day1 and day 15.
16175528|NCT01580969|Drug|Minocycline|Minocycline will be given by mouth twice a day at the assigned dose level. Minocycline will be started on the day prior to radiation and continued until progression or intolerance.
16175529|NCT01580969|Radiation|Radiation|Radiation planning will be individualized by the radiation oncologist based on the location of the current radiation field relative to prior radiation doses. The length and fractionation will be determined individually by the radiation oncologist.
16175530|NCT01580956|Other|VARIABLE-PSV ventilatory mode|The two ventilatory modes will be studied during 24h in intubated patients in random order.
16175531|NCT01580956|Other|STANDARD-PSV ventilatory mode|The two ventilatory modes will be studied during 24h in intubated patients in random order.
16175532|NCT01580943|Drug|Chlorhexidine|Over a 72-h experimental non-brushing period, subjects abstained from all forms of mechanical oral hygiene and one group (test) used an 0.12% CHX mouthrinse with 0.05% CPC (Perioaid®), twice daily for 30 seconds and the other group (positive control) used a 0.2% CHX mouthrinse alcohol free (Corsodyl® Care), twice daily for 60 seconds. These regimens are suggested by the manufacturers in the instructions
16175533|NCT01580943|Drug|Chlorhexidine|"All subjects received a questionnaire using a visual analogue scale designed to evaluate their taste to the mouthrinse, which they had used (What is your opinion concerning the taste of the mouth rinse?). Subjects marked a point on a 10 cm long uncalibrated line with the negative extreme response (0) on the left and the positive extreme (10) at the right end. Then, they were also asked about side effects in an open answer (Did you feel any side effects caused by mouth rinse?, If so, what are they?)."
16175534|NCT01580930|Behavioral|exercise training|12 weeks, 5 days of week, 40 min per session of exercise training
16175535|NCT01580930|Behavioral|sedentary time reduction|participants provided with strategies to decrease sitting
16175536|NCT01580930|Behavioral|exercsie training plus sedentary time reduction|12 weeks of exercise training (5 days a week, 40 min per session) plus given strategies for reducing sitting time
16175537|NCT01580904|Behavioral|Intervention: Pharmaceutical Care|Patients will be followed by the pharmacist by the Pharmaceutical Care Practice
16175538|NCT01580891|Drug|Naftifine HCl Cream 1%|Naftifine HCl Cream 1% applied topically once a day for 28 days.
16175539|NCT01580891|Drug|Naftin® (Naftifine HCl) Cream 1%|Naftin® (Naftifine HCl) Cream 1% applied topically once a day for 28 days.
16175540|NCT01580891|Drug|Placebo topical cream|Placebo topical cream applied topically once a day for 28 days.
16175541|NCT01580878|Drug|Butenafine Hydrochloride Cream, 1%|Butenafine Hydrochloride Cream, 1% applied twice daily for 7 consecutive days
16175542|NCT01580878|Drug|Lotrimin Ultra®|Lotrimin Ultra® (Butenafine Hydrochloride Cream, 1%) applied twice daily for 7 consecutive days.
16175543|NCT01580878|Drug|Butenafine Vehicle|Butenafine Vehicle applied twice daily for 7 consecutive days.
16175544|NCT01580865|Drug|Tacrolimus vs. Mycophenolate mofetil for Induction Therapy in Lupus Nephritis|Patients were randomly assigned to receive regimen I or II: TAC plus prednisolone (TAC group) or MMF plus prednisolone (MMF group). TAC was started at a dosage of 0.1 mg/kg/day divided into 2 daily doses at 12-hour intervals, and the dosage was titrated to achieve trough blood concentrations of 6-10 ng/mL in the first and second month and then 4-8 ng/mL., thereafter. MMF was initiated at a dose of 500 mg twice daily (for patients > 50 Kg and Estimated Glomerular Filtration rate (eGFR) > 60 ml/min) for 2 weeks, and advanced to 750 mg twice daily in LN patients weighing less than 50 kg or 1,000 mg twice daily in LN patients weighing 50 kg or more. Patients received concomitant prednisone at a dose of 0.5-0.7 mg/kg/d (maximum 60 mg/day), with tapering by 5-10 mg/day every 2 weeks until a dose of 5 mg/d has been achieved, and this dosage was maintained until the end of 24 weeks.
16175545|NCT01580852|Procedure|Dead Sea water|Subjects will immerse in mineral (dead sea) waters for twenty minutes twice daily for a period of 10 days
16175546|NCT01580852|Procedure|Pool water|Subjects will immerse in sweet(pool)waters for twenty minutes twice daily for a period of 10 days
16175547|NCT01580839|Drug|Tissue Plasminogen Activator (Alteplase)|0.9 mg/kg up to a maximum of 90mg, intravenous, 10% as bolus and the remainder over 1 hour
16175548|NCT01580839|Drug|Placebo|placebo provided as 50mg lyophilised powder to be reconstituted with sterile water in glass vials indistinguishable from active drug
16175549|NCT01580826|Other|pasteurization of mother's own milk|mother's milk heat treated at 62,5°C for 30 minutes with a Sterifeed® S75 TES pasteurizer.
16175550|NCT01580813|Drug|Acipimox|Subjects will take acipimox 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit.
16175551|NCT01580813|Drug|Placebo|Subjects will take a placebo pill 250mg (randomized and double-blinded) by mouth four times a day for six days prior to the visit and one dose the morning of study visit.
16175552|NCT01580787|Device|Balance Training with Nintendo Wii Fit|The participants of the study trained 10 balance games during 14 sessions.
16175553|NCT01580787|Other|Physical Therapy|Patients of the control group was trained with balance exercises.
16175554|NCT01580761|Behavioral|Sleep restriction|14 days of sleep restriction, 4 hours of sleep per day.
16175555|NCT01580748|Drug|Roflumilast|500 microgram once daily for 16 weeks
16175556|NCT01580735|Drug|ARQ 197|"ARQ 197:360 mg bid (CYP2C19 EM) or 240mg bid (CYP2C19 PM)
~erlotinib: 150 mg qd"
16175558|NCT01580722|Procedure|delay reconstruction|patients underwent > 8 weeks reconstruction after injury
16175559|NCT01580709|Procedure|Multiple brushings|Seven consecutive brush samples for cytology.
16175560|NCT01580709|Procedure|Multimodality tissue sampling|Single brush for cytology + single brush for FISH + cholangioscopy with site-directed biopsies
16175561|NCT01580696|Biological|E39 peptide (100mcg)/GM-CSF vaccine plus E39 booster|"100mcg lyophilized E39 peptide is suspended in bacteriostatic water for injection in individual cryovials and frozen. At the time of vaccine administration, the suspended peptide is thawed and mixed thoroughly with 250mcg GM-CSF in the syringe. This constitutes the E39 vaccine at this dose.
~Subsequently, patients will receive a booster of E39 dosed at 500mcg and mixed with 250mcg of GM-CSF. The boosters will be given at 6 and 12 months after completing the primary vaccine series above."
16175562|NCT01580696|Other|Non-vaccine clinically matched control group|HLA-A2-negative patients or HLA-A2-positive patients who decline the vaccine will be followed clinically as matched controls for disease recurrence/progression. No experimental treatment will be administered to this group.
16175563|NCT01580696|Biological|E39 peptide (500mcg)/GM-CSF vaccine plus E39 booster|"500mcg lyophilized E39 peptide is suspended in bacteriostatic water for injection in individual cryovials and frozen. At the time of vaccine administration, the suspended peptide is thawed and mixed thoroughly with 250mcg GM-CSF in the syringe. This constitutes the E39 vaccine at this dose.
~Subsequently, patients will receive a booster of E39 dosed at 500mcg and mixed with 250mcg of GM-CSF. The boosters will be given at 6 and 12 months after completing the primary vaccine series above."
16175564|NCT01580696|Biological|E39 peptide (1000mcg)/GM-CSF vaccine plus E39 booster|"1000mcg lyophilized E39 peptide is suspended in bacteriostatic water for injection in individual cryovials and frozen. At the time of vaccine administration, the suspended peptide is thawed and mixed thoroughly with 250mcg GM-CSF in the syringe. This constitutes the E39 vaccine at this dose.
~Subsequently, patients will receive a booster of E39 dosed at 500mcg and mixed with 250mcg of GM-CSF. The boosters will be given at 6 and 12 months after completing the primary vaccine series above."
16175565|NCT01580696|Biological|E39 peptide (100mcg)/GM-CSF vaccine plus J65 booster|"100mcg lyophilized E39 peptide is suspended in bacteriostatic water for injection in individual cryovials and frozen. At the time of vaccine administration, the suspended peptide is thawed and mixed thoroughly with 250mcg GM-CSF in the syringe. This constitutes the E39 vaccine at this dose.
~Subsequently, patients will receive a booster of J65 dosed at 500mcg and mixed with 250mcg of GM-CSF. The boosters will be given at 6 and 12 months after completing the primary vaccine series above."
16175566|NCT01580696|Biological|E39 peptide (500mcg)/GM-CSF vaccine plus J65 booster|"500mcg lyophilized E39 peptide is suspended in bacteriostatic water for injection in individual cryovials and frozen. At the time of vaccine administration, the suspended peptide is thawed and mixed thoroughly with 250mcg GM-CSF in the syringe. This constitutes the E39 vaccine at this dose.
~Subsequently, patients will receive a booster of J65 dosed at 500mcg and mixed with 250mcg of GM-CSF. The boosters will be given at 6 and 12 months after completing the primary vaccine series above."
16175567|NCT01580696|Biological|E39 peptide (1000mcg)/GM-CSF vaccine plus J65 booster|"1000mcg lyophilized E39 peptide is suspended in bacteriostatic water for injection in individual cryovials and frozen. At the time of vaccine administration, the suspended peptide is thawed and mixed thoroughly with 250mcg GM-CSF in the syringe. This constitutes the E39 vaccine at this dose.
~Subsequently, patients will receive a booster of J65 dosed at 500mcg and mixed with 250mcg of GM-CSF. The boosters will be given at 6 and 12 months after completing the primary vaccine series above."
16175568|NCT01580683|Drug|Ascorbic Acid|Two 1 g capsules the evening prior to surgery, followed by one 1 g capsule every 12 hours starting the morning of the first postoperative day for 5 days.
16175569|NCT01580683|Other|Identical Placebo|Two capsules the evening prior to surgery, followed by one capsule every 12 hours starting the morning of the first postoperative day for 5 days.
16175570|NCT01580670|Drug|TA-650|TA-650 will be intravenously infused at 5 mg/kg as an induction regimen at Week 0, 2, 6. For subjects who meet the responder criteria, TA-650 will be administered at 8-week intervals thereafter until week 46. If the criteria for a dosage escalation are met, TA-650 will be administered at a dosage of 10 mg/kg.
16175571|NCT01580657|Behavioral|Detailed baseline interview, enhanced HIV intervention|Participants in this group will receive a detailed sexual behavior interview, similar to measures used in major intervention trials. This measure will identify the instances in which participants engaged in sexual behaviors with specific partners during a 90 day retrospective reporting period. Participants will then complete an empirically validated 60-minute session HIV-risk reduction intervention (Simbayi, Kalichman, Skinner et al., 2004) consisting of exercises to increase HIV/AIDS knowledge, motivation to reduce risk, behavior self-management skills, and sexual communication skills and reduce HIV-related stigma.
16175572|NCT01580657|Behavioral|General baseline interview, enhanced HIV intervention|Participants in this group will receive the same procedures as in (A) except that the behavioral measure will consist of single-item frequency questions regarding sexual behaviors during the prior 90 days, questions that do not lead the participant to focus on specific instances of behavior.
16175573|NCT01580657|Behavioral|No baseline interview, enhanced HIV intervention|This group will receive the same enhanced intervention procedures as in (A) and (B), but they will not be interviewed at baseline.
16175574|NCT01580657|Behavioral|Detailed baseline interview, standard of care intervention|Participants in this group will receive the same interview procedure as in (A) but instead of the enhanced intervention, They will undergo the standard clinical exam and health education that at the Spencer Rd. Clinic.
16175575|NCT01580657|Behavioral|General baseline interview, standard of care intervention|Participants in this group will complete the general baseline interview described in (B) and then receive the standard care at the clinic.
16175576|NCT01580657|Behavioral|No baseline interview, standard of care intervention|Participants assigned to this group will be consented on the day they are recruited, but will not receive further study contact on that day other than being scheduled to return for follow up assessments.
16175577|NCT01580644|Drug|GLPG0187 prodrug|
16175578|NCT01580618|Drug|normal saline|Injection of 60 ml normal saline twice a day for three days using the existing chest tube.
16175579|NCT01580618|Drug|TNK (Tenecteplase)|Injection of 4 mg of TNK with 59 ml normal saline into the existing chest tube twice a day for three days.
16175627|NCT01580189|Dietary Supplement|Whey protein|18g protein, immediately after training, 9 weeks
16178583|NCT01557764|Drug|lapatinib ditosylate|Given PO
16175580|NCT01580605|Drug|somatropin|"Data are extracted from the French National Registry l'Observatoire National des Prescriptions et Consommations de Médicaments to where physicians report data about growth hormone treatment"
16175581|NCT01580592|Drug|Omalizumab|150mg, s.c., every 4 weeks
16175582|NCT01580592|Drug|Omalizumab|300mg, s.c., every 4 weeks
16175583|NCT01580592|Drug|Placebo|Placebo, s.c., every 4 weeks
16175584|NCT01580553|Drug|Levocarnitine Injection|Levocarnitine Injection:5ml:1g
16175585|NCT01580553|Drug|Levocarnitine placebo|L-Carnitine injection placebo (5ml:1g)
16175586|NCT01580527|Procedure|Total parenteral nutrition|Total parenteral nutrition in postoperative of pancreaticoduodenectomy
16175587|NCT01580527|Procedure|Enteral nutrition|Early enteral nutrition in postoperative of pancreaticoduodenectomy
16175588|NCT01580514|Drug|exenatide BYETTA® (Amylin-Lilly)|"After informed consent was obtained, patients who met the enrollment criteria were randomly assigned to either the control group or the exenatide group.
~Patients assigned to exenatide were treated with 10 μg subcutaneous and 10 μg intravenously injection of exenatide BYETTA® (Amylin-Lilly) 5 min before the onset of reperfusion. And twice daily 10 μg subcutaneous injection was continued on the following 2 days."
16175589|NCT01580514|Drug|Saline|"After informed consent was obtained, patients who met the enrollment criteria were randomly assigned to either the control group or the exenatide group.
~Patients assigned to saline were treated with 10 μg subcutaneous and 10 μg intravenously injection of equivalent volume of normal saline 5 min before the onset of reperfusion. And twice daily 10 μg subcutaneous injection was continued on the following 2 days."
16175590|NCT01580501|Drug|Tadalafil and Sildenafil|PDE-5 Inhibitor; Low dosages will be 0.5mg/kg and high dosages will be 1.0mg/kg
16175591|NCT01580488|Drug|B LEO 35299 20 mg/g cream|once daily application, 3 weeks
16175592|NCT01580488|Drug|C LEO 35299 20 mg/g cream|once daily application, 3 weeks
16175593|NCT01580488|Drug|E LEO 35299 10 mg/g solution|once daily application, 3 weeks
16175594|NCT01580488|Drug|F LEO 35299 10 mg/g solution|once daily application, 3 weeks
16175595|NCT01580488|Drug|Daivonex® ointment|once daily application, 3 weeks
16175596|NCT01580488|Drug|Daivonex® ointment vehicle|once daily application, 3 weeks
16175597|NCT01580475|Other|Training - detraining - retraining|Thirteen women with type 2 diabetes followed a supervised aerobic and strength training program for 9 months, interrupted for 3 months (detraining) and resumed again for a period of 9 months (retraining).
16175598|NCT01580462|Other|Observational study|"Study plan - data collecting:
~Patients will attend diabetes clinic as usual, with one additional visit in the middle of the 3-months period. During those visits - V0, V1 and V2, data from glucometers and insulin pumps will be downloaded."
16175599|NCT01580436|Procedure|Tricuspid Valve Annuloplasty|Concomitant Tricuspid Valve Annuloplasty in patients undergoing mitral valve surgery
16175600|NCT01580423|Drug|aprepitant|125 mg capsule
16175601|NCT01580423|Drug|placebo|capsule identical to aprepitant
16175602|NCT01580410|Drug|mitomycin C|Given by HIPEC
16175603|NCT01580410|Drug|oxaliplatin|Given by HIPEC
16175604|NCT01580410|Procedure|therapeutic conventional surgery|Undergo surgery
16175605|NCT01580410|Other|quality-of-life assessment|Ancillary studies
16175606|NCT01580410|Drug|hyperthermic intraperitoneal chemotherapy|Undergo HIPEC
16175607|NCT01580397|Drug|INNO-206|INNO-206 at a total dose of 350 mg/m2 (260 mg/m2 doxorubicin equivalent) will be administered as a 30 minute IV infusion every 21 days.
16175608|NCT01580371|Drug|CKD-581|CKD-581 qd for Day 1, 8 and 15 every 28days/Cycle
16175609|NCT01580358|Drug|Shen-Mai San|Shen mai san is composed of three herb medicines, Ginseng radis, Liriope spicata, and Schizandrae fructus and was manufactured into concentrated herbal extract and packed with 0.5g per capsule and labeled by Sun-Ten pharmaceutical company in Taiwan with good manufacturing practice (GMP).
16175610|NCT01580358|Drug|Starch|It was packed in granules with 0.5gm starch. Patients took eight granules three times per day for four weeks.
16175611|NCT01580345|Dietary Supplement|Docosa-hexaenoic acid (DHA)|400 mg/day of Docosa-hexaenoic Acid (algal DHA) will given to the pregnant women (in the active group) from ≤20 weeks of gestation through delivery.
16175612|NCT01580345|Dietary Supplement|Placebo|400 mg/day of placebo (corn/soy oil) will be given to the pregnant women from ≤20 weeks of gestation through delivery.
16175613|NCT01580319|Other|physical exercise|150 minutes per week
16175614|NCT01580306|Drug|BI 201335|Relevant treatment dose capsule (A) for oral administration
16175615|NCT01580306|Drug|BI 201335|Relevant treatment dose capsule (B) for oral administration
16175616|NCT01580293|Biological|BAY94-9027|Intravenous infusion of BAY94-9027
16175617|NCT01580280|Other|Thrust Manipulation|Upper cervical and upper thoracic thrust manipulation for 6-8 sessions over 2-4 weeks.
16175618|NCT01580280|Other|Non-thrust Mobilization and Exercise|Upper cervical and upper thoracic non-thrust mobilization and exercise for 6-8 sessions over 2-4 weeks.
16175619|NCT01580254|Drug|IOPIZE© Latanoprost eyedrops|patients will receive in each eligible eye one drop of IOPIZE© Latanoprost eyedrops once a day, in the evening (8pm), for two months
16175620|NCT01580254|Drug|GALAXIA© Latanoprost eyedrops|patients will receive in each eligible eye one drop of GALAXIA© Latanoprost eyedrops once a day, in the evening (8pm), for two months
16175621|NCT01580254|Drug|Latanoprost RATIOPHARM© latanoprost eyedrops|patients will receive in each eligible eye one drop of Latanoprost RATIOPHARM© Latanoprost eyedrops once a day, in the evening (8pm), for two months
16175622|NCT01580228|Drug|Dinaciclib|Dinaciclib administered intravenously over 2 hours at a dose of 7 mg/m^2 on Day 1, 10 mg/m^2 on Day 8, and 14 mg/m^2 on Day 15 in Cycle 1. Starting in Cycle 2 and thereafter, dinaciclib will be dosed at 14 mg/m^2 on Days 1, 8, and 15 of each 28-day cycle for a total of 12 cycles.
16175623|NCT01580228|Drug|Ofatumumab|Ofatumumab administered intravenously at a dose of 300 mg on Cycle 1 Day 1, followed by 2000 mg on Cycle 1 Days 8, 15, and 22; Cycle 2 Days 1, 8, 15, and 22; followed 5 weeks later on Day 1 of Cycles 4-12.
16175624|NCT01580215|Device|Zephyr Endobronchial Valve (EBV)|• Implantation of at least one Zephyr EBV following Chartis assessment
16175625|NCT01580202|Drug|Entecavir|Entecavir 0.5mg daily per os
16175626|NCT01580202|Drug|Lamivudine|lamivudine 100mg daily per os
16178584|NCT01557764|Biological|trastuzumab|Given IV
16175628|NCT01580189|Dietary Supplement|Chocolate milk|500ml chocolate milk, immediately after training, 9 weeks
16175629|NCT01580189|Dietary Supplement|Sugar|55-65g maltodextrin solution, immediately after training, 9 weeks
16175630|NCT01580176|Device|continuous GlucoseMonitor|The blood glucose and blood lactate levels will be taken continuously by the Continuous GlucoseMonitor and will be recorded twelve times.
16175631|NCT01580163|Drug|JITAI Combined with psychological intervention|tablet，Each tablet weight 0.4g
16175632|NCT01580163|Drug|Methadone|Oral Solution，1mg/ml
16175633|NCT01580163|Drug|Traditional Chinese Medicine JITAI|tablet，Each tablet weight 0.4g
16175634|NCT01580150|Other|Berries|Meals containing starch (bread) or sucrose are consumed with berries (150 g) or berry nectars (300 mL).
16175635|NCT01580150|Other|No berries|Meals containing starch (bread) or sucrose are consumed without berries.
16175636|NCT01580124|Procedure|PVI alone|PVI alone Pulmonary vein isolation alone in persistent atrial fibrillation
16175637|NCT01580124|Procedure|PVI + Defragmentation + linear lesions|PVI + Defragmentation + linear lesions AF ablation continuation aiming for AF termination
16175638|NCT01580111|Biological|Blood transfusion|The short storage arm; children were transfused with packed red cells of storage age 1-10 days; while for the Long storage arm; were transfused with packed red cells of 21- 35 days in storage.
16175639|NCT01580098|Other|Self-monitoring for patients with Diabetes mellitus type 2|Patients are submitting their vital parameters via a Web Portal or automatic devices to the hospital.
16175640|NCT01580098|Other|Nurse-monitoring for patients with Diabetes mellitus type 2|Nurses are submitting the vital parameters of the patient via mobile device.
16175641|NCT01580085|Other|polysomnography|full night supervised laboratory polysomnography
16175642|NCT01580072|Other|self-monitoring for patients with severe COPD|Intervention Group entering vital parameters via Web Portal or automatic call center.
16175643|NCT01580072|Other|nurse-monitoring for patients with severe COPD|Nurses are entering vital parameters of the patient with mobile devices.
16175644|NCT01580046|Drug|iodixanol|"coronary angiography, 32gI/100ml, 40～60 ml once injection
~left ventricular, aortic root and selective coronary angiography, 32gI/100ml, 30～60 ml once injection"
16175645|NCT01580046|Drug|iopromide|coronary angiography, 370mgI/ml(0.769gIopromide/ml),5～8 ml once injection
16175646|NCT01580033|Biological|A+C+hib Conjugate Vaccine|The group A, C polysaccharide meningococcal and type b haemophilus influenzal conjugate vaccine (Wuxi Royal Biological Co., LTD, 20110101) will be administered on one arm, intramuscularly, per 0.5ml dose
16175647|NCT01580033|Biological|Placebo|Placebo will be administered intramuscularly on the other arm, intramuscularly, per 0.5ml dose
16175648|NCT01580033|Biological|A+C Vaccine|The group A, C polysaccharide meningococcal vaccine (Yunnan Walvax Biotechnology Co., LTD, 20101202) will be administered intramuscularly on one arm, per 0.5ml dose
16175649|NCT01580033|Biological|Hib vaccine|The type b haemophilus influenzal vaccine (Sanofi Pasteur Limited) will be administered intramuscularly on the other arm, per 0.5ml dose
16175650|NCT01580020|Biological|RFB002|0.5 mg/0.05 mL solution to be injected intravitreally. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial. Each vial contained ranibizumab in an aqueous solution (pH 5.5) with histidine, trehalose and polysorbate 20.
16175651|NCT01580020|Drug|Dexamethasone|Ozurdex (Dexamethasone): intravitreal implant as per commercial label (700 µg Dexamethasone; Dexamethasone was formulated as a rod shaped implant to be inserted into the eye by an applicator. The implant as well as the respective applicator were suitable for single use only. Dexamethasone had to be stored according to label instructions and it had to be kept in a secure locked facility
16175652|NCT01580007|Drug|Active Sodium Phenylbutyrate and active cholecalciferol|Sodium Phenylbutyrate: 500 mg twice daily orally for 2 months Cholecalciferol: 5000 IU once daily orally for 2 months
16175653|NCT01580007|Drug|Placebo Sodium Phenylbutyrate plus active cholecalciferol|Placebo Sodium Phenylbutyrate: twice daily orally for 2 months Cholecalciferol: 5000 IU once daily for 2 months
16175654|NCT01580007|Drug|Active Sodium Phenylbutyrate and placebo cholecalciferol|Sodium phenylbutyrate: 500 mg twice daily orally for 2 months Placebo cholecalciferol: once daily orally for 2 months
16175655|NCT01580007|Drug|Placebo Sodium Phenylbutyrate plus placebo cholecalciferol|Placebo Sodium Phenylbutyrate: twice daily orally for 2 months Placebo cholecalciferol: once daily orally for 2 months
16175656|NCT01579994|Drug|Ganetespib (STA-9090) and crizotinib|Ganetespib (STA-9090) is given intravenously (days 1 and 8 of a 21 day cycle). Crizotinib will be given at the FDA approved dose of 250mg orally twice daily in a continuous fashion.
16175657|NCT01579981|Procedure|Roux-en-Y Gastric Bypass|On two separate experimental days before, 1 wk, and 3 months after RYGB, subjects are given a liquid meal test during Exendin 9-39 (900 pmol/min/kg)or saline infusion. The order of the infusions is randomized. At end of study day an ad libitum meal is served.
16175658|NCT01579968|Drug|eptacog alfa (activated)|Safety and effectiveness data collection in connection with the use of eptacog alpha in daily clinical practice
16175659|NCT01579955|Drug|eptacog alfa (activated)|Prescription of eptacog alpha at the discretion of the physician
16175660|NCT01579929|Drug|LDE225, Etoposide and Cisplatin|In a standard, 3 + 3 dose escalation phase, two successive cohorts of ES-SCLC patients will receive LDE225 with etoposide and cisplatin with a dose of 200 mg to be reserved for de-escalation until the MTD is determined. Cohorts of at least 3 evaluable patients will be treated at each dose level of LDE225 (400 mg daily and 800 mg daily). One additional dose (200 mg daily) will be reserved for de-escalation. A minimum of 6 evaluable patients must be treated at the dose declared to be the MTD. Each cohort will consist of newly enrolled patients. An estimated total of 6 to 12 patients may be necessary to establish the MTD. Actual accrual will depend on the dose levels tested and the DLT observed. Upon completion of a minimum of four and a maximum of six cycles of LDE225 with etoposide and cisplatin, patients in each cohort with at least stable disease will receive maintenance LDE225 until disease progression or unacceptable toxicity.
16175661|NCT01579916|Biological|Trivalent Influenza Virus Vaccine|Trivalent vaccine is supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose phosphate buffer, egg allantoic fluid and approximately 10^7 FFU (fluorescent focus units) of each of 3 cold-adapted, attenuated 6:2 reassortant influenza strains: A/H1N1 (A/California/7/2009), A/H3N2 (A/Victoria/361/2011), B (B Wisconsin/1/2010). A single dose of investigational product was administered on Day 1.
16175662|NCT01579916|Other|Placebo|Placebo is suppllied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer. A single dose of investigational product was administered on Day 1.
16175663|NCT01579903|Drug|moroctocog alfa (AF-CC)|Treatment A: 3000 IU moroctocog alfa (AF-CC) dual chamber syringe (including diluent); Treatment B: 1000 IU + 2000 IU moroctocog alfa (AF-CC) vials and separate diluent syringes
16175664|NCT01579903|Drug|moroctocog alfa (AF-CC)|Treatment B: 1000 IU + 2000 IU moroctocog alfa (AF-CC) vials and separate diluent syringes; Treatment A: 3000 IU moroctocog alfa (AF-CC) dual chamber syringe (including diluent)
16175665|NCT01579890|Drug|Diclofenac|diclofenac topical lotion
16175666|NCT01579877|Dietary Supplement|Herbal extract granule|The herbal extract granule, Yukmijihwang-tang granule, consists of 6 herbs. Ingredients: Rehmanniae Radix, Deoscoreae Radix, Corni Fructus, Hoelen, Alismatis Radix, Paeoniae Radicis Cortex. Dosage and frequency: 1 pack (3g), 3 packs per day (2 hours after morning, afternoon and evening meal)
16175667|NCT01579877|Dietary Supplement|Placebo herbal extract granule|The Yukmijihwang-tang_Placebo has the same form, color and flavor as experimental intervention (Yukmijihwang-tang). The dosage, frequency and duration is also the same as experimental intervention (Yukmijihwang-tang).
16175668|NCT01579864|Drug|succinylcholine|Succinylcholine 1 mg/kg and a second dose if necessary. Rocuronium 0,4 mg/kg can be used as a rescue
16175669|NCT01579864|Drug|rocuronium|rocuronium 0,9 mg/kg with additional boluses of 0,3 mg/kg f necessary
16175670|NCT01579851|Drug|Sugammadex|"sugammadex
~4 mg/kg : if there is no response to Train of Four stimulations and at least one response to the Post Tetanic Count
~2 mg/kg : if there is at least two responses to Train of Four stimulations"
16175671|NCT01579838|Drug|Eculizumab|PNH and or atypical TTP classical protocols
16175672|NCT01579825|Other|Buffer|5 ml of oral buffer solution containing 64 mg of sodium bicarbonate plus 24 mg of sodium citrate. The buffer will be administered prior to each dose of OPV at 6, 10 and 14 weeks of age.
16175673|NCT01579812|Drug|Metformin|"Patients receiving primary surgical debulking followed by adjuvant chemotherapy will initiate metformin prior to primary surgery. Following surgery patients will be initiated on metformin prior to the initiation of chemotherapy.
~Patients treated with neoadjuvant chemotherapy will be initiated on metformin prior to the initiation of chemotherapy. Following surgery patients will be initiated on metformin prior to the re-initiation of chemotherapy."
16175674|NCT01579799|Drug|L-lysine|Dose finding study for L-lysine
16175675|NCT01579786|Procedure|Acetaminophen and acupuncture|All patients will receive acetaminophen (maximum 3g/day) for all seven days after surgery and will receive acupuncture treatment at first day after performing surgery and thirty minutes before operation
16175676|NCT01579760|Drug|Aflibercept every 2 months|2.0 mg aflibercept intravitreal injections once per month for the first 3 months (M0, M1, M2), then every 2 months (M4, M6, M8, M10)
16175677|NCT01579760|Drug|Aflibercept monthly|2.0mg aflibercept intravitreal injections every month (M0-11)
16175678|NCT01579747|Procedure|Ultrasound|Using ultrasound for nerve localization when performing a sciatic nerve block via the lateral popliteal approach
16175679|NCT01579747|Procedure|Nerve stimulation|Using nerve stimulation for nerve localization in sciatic nerve blocks via the lateral popliteal approach
16175680|NCT01579734|Drug|Tamoxifen|1 tablet, 5 mg / day for 5 years
16175681|NCT01579734|Drug|Placebo|1 tablet day for 5 years
16175682|NCT01579721|Procedure|Single Incision Laparoscopic Surgery|Single incision laparoscopic surgery for rectal cancer
16175683|NCT01579708|Behavioral|Program SI! educational intervention|School-based educational program to improve the knowledge, the attitudes, and the habits of children, their parents and teachers, with respect to a healthy lifestyle behavior.
16175684|NCT01579695|Drug|Tesamorelin for injection|Daily 2 mg subcutaneous injections of Tesamorelin
16175685|NCT01579682|Behavioral|Family-Based Therapy (FBT)|12 sessions of FBT over the course of 6 months.
16175686|NCT01579682|Behavioral|Family-Based Therapy with Intensive Family-Focused treatment|FBT for 4 weeks then Intensive Family-Focused treatment (IFT) should the participant not make adequate weight progress within the time frame.
16175687|NCT01579669|Behavioral|Use of toolkit|Patient participants will be given access to the toolkit and will create a customized report for their provider. Team will send report to providers and ask them to schedule appointment with patient to discuss.
16175688|NCT01579656|Dietary Supplement|Salba|25g of ground Salba baked into a bran muffin matched for total available carbohydrate (50g), total dietary fibre (15g), and calories (494.5 kcal) with the addition of flour, inulin or canola oil. One of five muffins (Salba, Poppy, Sesame, Flax, Bran) will be administered at each visit.
16175689|NCT01579656|Dietary Supplement|Poppy|25g of ground Poppy Seeds baked into a bran muffin matched for total available carbohydrate (50g), total dietary fibre (15g), and calories (494.5 kcal) with the addition of flour, inulin or canola oil. One of five muffins (Salba, Poppy, Sesame, Flax, Bran) will be administered at each visit.
16175690|NCT01579656|Dietary Supplement|Flaxseed|25g of ground Flaxseed baked into a bran muffin matched for total available carbohydrate (50g), total dietary fibre (15g), and calories (494.5 kcal) with the addition of flour, inulin or canola oil. One of five muffins (Salba, Poppy, Sesame, Flax, Bran) will be administered at each visit.
16175691|NCT01579656|Dietary Supplement|Sesame|25g of ground Sesame Seeds baked into a bran muffin matched for total available carbohydrate (50g), total dietary fibre (15g), and calories (494.5 kcal) with the addition of flour, inulin or canola oil. One of five muffins (Salba, Poppy, Sesame, Flax, Bran) will be administered at each visit.
16175692|NCT01579656|Dietary Supplement|Wheat Bran|Bran muffin matched for total available carbohydrate (50g), total dietary fibre (15g), and calories (494.5 kcal). One of five muffins (Salba, Poppy, Sesame, Flax, Bran) will be administered at each visit.
16175693|NCT01579643|Procedure|OCT guided laser-assisted lamellar anterior keratoplasty (LALAK)|"The top hat-shaped donor cornea graft with tapered brim will be cut using a femtosecond (fs) laser at the eye bank. An anterior diameter of 6.0 mm will be used. The depth of the anterior side cut will match the planned excimer ablation depth.
~The host cornea bed will be prepared with an excimer laser.
~Descemet's membrane will be peeled off the graft, and the graft sutured into the host bed."
16175694|NCT01579643|Procedure|Penetrating Keratoplasty (KP)|"A trephine is used to perform a full thickness cut of a round area of cornea from the both patient's and donor's cornea.
~The donor cornea is then sutured where the patient's cornea was."
16175695|NCT01579630|Drug|Pemetrexed 500mg/m2 iv|EGFR mutation negative patients who continuously respond (CR, PR or SD) to the 4th cycle of pemetrexed/ cisplatin or pemetrexed/carboplatin will be randomized in a 1:1 ratio to receive either gefitinib/ pemetrexed, or pemetrexed alone as maintenance therapy until progression of disease (PD) or discontinuation of treatment for other reasons.
16175696|NCT01579630|Drug|Pemetrexed 500mg/m2 iv and Gefitinib 250 mg|EGFR mutation negative patients who continuously respond (CR, PR or SD) to the 4th cycle of pemetrexed/ cisplatin or pemetrexed/carboplatin will be randomized in a 1:1 ratio to receive either gefitinib/ pemetrexed, or pemetrexed alone as maintenance therapy until progression of disease (PD) or discontinuation of treatment for other reasons.
16175697|NCT01579617|Behavioral|BUtiful.|8 website sessions include themes that teach: gender empowerment, assertive communication skills, goal setting, pregnancy and STI/HIV risk, safer sex behaviors, proper condom use, positive attitudes and norms towards consistent condom use, contraception, partner involvement in safer sex, and responsibility for their own health.
16175698|NCT01579617|Behavioral|DIVAS.|Attention control arm: 8 website sessions that include topics on: healthy eating, choosing nutritional snacks, sugar and salt intake, physical activity, stress management, foods for beauty.
16175699|NCT01579604|Procedure|Nerve reconstruction|Under general anesthetic, the surgeon will make a cut on the back (dorsal) part of the forearm. The radial nerve will be identified and specifically the branches which control the supinator muscle and the remainder of the radial nerve (Posterior interosseous nerve or PIN). . The PIN branch will be stimulated to ensure that it is non-functional. Then, the supinator branch will be stimulated to ensure it is functioning and is appropriate for transfer. If appropriate, the supinator branch will be severed and connected to the EDC branch under the operating room microscope. After the surgery, the patient will be placed into a splint including the forearm and hand for 2-3 weeks.
16175700|NCT01579591|Other|VSL#3|1 sachet (4.5x1011 viable lyophilized bacteria)three times in a day, during RT and for 2 weeks before and for 4 weeks afterwards.
16175701|NCT01579591|Other|Placebo|1 sachet, three times in a day, during RT and for 2 weeks before and for 4 weeks afterwards
16175702|NCT01579578|Drug|AZD8931|40 mg, oral dose twice daily
16175703|NCT01579578|Drug|Placebo|Placebo, oral dose twice daily
16175704|NCT01579578|Drug|Paclitaxel|IV once weekly for 3 weeks followed by a week off.
16175705|NCT01579565|Drug|OMS302|OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL solution containing 60.75 millimolar (mM) phenylephrine hydrochloride (HCl) and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available balanced saline salt (BSS) through a syringe filter. This will achieve 4.0 mL of the drug product in a 500 mL bottle of BSS.
16175706|NCT01579565|Drug|Placebo|Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available BSS through a syringe filter. This will achieve 4.0 mL of the drug product in a 500 mL bottle of BSS.
16175707|NCT01579552|Behavioral|survey, questionaire|The intervention components (mailed tailored print materials followed by telephone-delivered Brief MI). Following enrollment into the study and completion of the informed consent form and baseline survey, participants will be randomized to the active intervention group or the attention control group. The data that will be used in the analysis will come from the baseline survey, medical records of breast imaging studies, and a 12-month follow-up questionnaire.
16175708|NCT01579552|Behavioral|survey, questionaire|The intervention components (mailed tailored print materials followed by telephone-delivered Brief MI). Following enrollment into the study and completion of the informed consent form and baseline survey, participants will be randomized to the active intervention group or the attention control group. The data that will be used in the analysis will come from the baseline survey, medical records of breast imaging studies, and a 12-month follow-up questionnaire.
16175709|NCT01579539|Drug|Methylprednisolone|500mg i.v. infusion once a week for 6 weeks followed by 250mg i.v. infusion once a week for 6 weeks
16175710|NCT01579539|Drug|Esomeprazole|40mg i.v. infusion once a week for 12 weeks
16175711|NCT01579526|Drug|FP01|comparison of different dosages
16175712|NCT01579513|Drug|Methylprednisolone|Methylprednisolone at a dose of 30 mg/kg body weight and a concentration of 62.5 mg/cc. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia.
16175713|NCT01579513|Drug|Placebo|Normal saline will be drawn up in an identical volume to that needed for active study drug. The study drug will be delivered in a blinded fashion to the anesthesiologist and will be administered intravenously with the induction of anesthesia.
16175714|NCT01579500|Drug|Botulinum toxin type A|Subcutaneous injection of botulinum toxin type A
16175715|NCT01579500|Drug|normal saline|Subcutaneous injection of normal saline
16175716|NCT01579487|Device|The Zeltiq System|This is a follow-up study from the initial treatments performed in 2010. No additional treatments will be performed.
16175717|NCT01579474|Drug|BI 201335 high dose|BI 201335 high dose with PegIFN/RBV
16175718|NCT01579474|Drug|BI 201335 low dose|BI 201335 low dose with PegIFN/RBV
16175719|NCT01579474|Drug|BI 201335 high dose|BI 201335 high dose with PegIFN/RBV
16175720|NCT01579474|Drug|BI 201335 high dose|BI 201335 high dose with PegIFN/RBV
16175721|NCT01579461|Drug|mirabegron|oral
16175722|NCT01579448|Biological|Shanchol™, oral cholera vaccine|"This killed, whole cell, bivalent vaccine will be presented as a creamish white suspension. Upon storage, a white sediment and clear supernatant may be observed. The recommended dose (1.5ml) of the vaccine must be administered orally. The primary vaccination schedule consists of two doses given at an interval of two weeks. After vigorous shaking of the vial, 1.5 ml should be poured into the mouth of the recipient, followed by water ad libitum. The vaccine can alternatively be administered with a disposable syringe (without needle) after removing the contents from the vial and squirted into the mouth of the recipient.
~Vaccine is administered in 1.5 mL vials by mouth in 2 doses, given 2 weeks apart. The vaccine appears as a creamy white suspension."
16175837|NCT01578603|Dietary Supplement|casein phosphopeptide amorphous calcium phosphate complex|two pieces of the commercial presentation three times daily after meals
16175723|NCT01579448|Biological|Shanchol™, killed, whole cell, bivalent, oral cholera vaccine|"This killed, whole cell, bivalent vaccine will be presented as a creamish white suspension. Upon storage, a white sediment and clear supernatant may be observed. The recommended dose (1.5ml) of the vaccine must be administered orally. The primary vaccination schedule consists of two doses given at an interval of two weeks. After vigorous shaking of the vial, 1.5 ml should be poured into the mouth of the recipient, followed by water ad libitum. The vaccine can alternatively be administered with a disposable syringe (without needle) after removing the contents from the vial and squirted into the mouth of the recipient.
~Vaccine is administered in 1.5 mL vials by mouth in 2 doses, given 2 weeks apart. The vaccine appears as a creamy white suspension."
16175724|NCT01579448|Other|no intervention|No intervention will be given to this arm of past placebo recipients. To ensure that boosting was not due to natural exposure to Vibrio cholera, we will compare subjects in the boosting arm to this no intervention arm.
16175725|NCT01579435|Device|transcranial direct current stimulation|Active stimulation: duration: 20 mn, intensity: 2 mA; localisation : motor cortex or cerebellum; Placebo stimulation: duration: 9 seconds, intensity: 2 mA; localisation : motor cortex or cerebellum;
16175726|NCT01579422|Behavioral|social cognitive training|social cognitive training, 8-10 sessions
16175727|NCT01579409|Other|PNNS guidelines|Application of PNNS guidelines
16175728|NCT01579396|Device|septeX|12 h septeX CVVH treatment after cardiac surgery
16175729|NCT01579396|Other|standard therapy|standard therapy either pharmacological and /or continuous renal replacement therapy (CRRT)
16175730|NCT01579383|Biological|ALD403|Single Dose IV infusion on Day 1
16175731|NCT01579383|Biological|ALD403|Single Dose subcutaneous injection on Day 1
16175732|NCT01579383|Biological|Sumatriptan|Single Dose subcutaneous injection on Day 1
16175733|NCT01579370|Other|Quaternary ammonium|"Rooms from which a patient with a target organisms has been discharged (ie, a seed room) will be cleaned using quaternary-ammonium containing solutions. Room cleaning will proceed following standard cleaning protocols established at each study hospital."
16175734|NCT01579370|Other|Bleach|"Rooms from which a patient with a target organisms has been discharged (ie, a seed room) will be cleaned using bleach containing solutions. Room cleaning will proceed following standard cleaning protocols established at each study hospital."
16175735|NCT01579370|Other|Quaternary ammonium and UV-C light|"Rooms from which a patient with a target organisms has been discharged (ie, a seed room) will be cleaned using quaternary-ammonium containing solutions. Room cleaning will proceed following standard cleaning protocols established at each study hospital. Then, the UV-C light-emitting device will be brought to the room to irradiate the room until 12,000 uWs/cm2 (for vegetative bacteria) or 22,000 uWs/cm2 (for C. difficile) has been delivered to entire room."
16175736|NCT01579370|Other|Bleach and UV-C light|"Rooms from which a patient with a target organisms has been discharged (ie, a seed room) will be cleaned using bleach containing solutions. Room cleaning will proceed following standard cleaning protocols established at each study hospital. Then, the UV-C light-emitting device will be brought to the room to irradiate the room until 12,000 uWs/cm2 (for vegetative bacteria) or 22,000 uWs/cm2 (for C. difficile) has been delivered to entire room."
16175737|NCT01579357|Other|blood samples|"Draw blood samples in week 1 (day 1 and day 5), in week 4 (day 1 and day 5) and in week 7 (day 1 and day 5).
~day 1: pre dose, 30,60,90,120,150,180,240,300 and 360min day 5: pre dose, 30,60,90,120min"
16175738|NCT01579344|Drug|Radioiodine therapy|Radioiodine therapy with NaI131
16175739|NCT01579331|Device|DCT (PASCAL© Tonometer) IOP and OPA measurement|"Healthy volunteers recruited among subject that underwent a routine ophthalmologic evaluation or among both students and workers at our clinic, will undergo a series of 5 Dynamic contour tonometries to evaluate eventual differences among measurements.
~Patients will be controlled for 30 days. A diurnal IOP curve performed though GAT, composed of 3 measurements (9am, noon, 4pm) will be taken 1 to 7 days before the DCT. At the end of the DCT measurements a last GAT will be taken to control eventual IOP changes versus previous GAT values obtained through the diurnal curve."
16175740|NCT01579318|Biological|Tavokinogene Telseplasmid (tavo)|Patients received intratumoral injection(s) of tavo.
16175741|NCT01579318|Device|OncoSec Medical System (OMS)|Electroporation via OMS was performed immediately following intratumoral injection of tavo. A sterile applicator containing 6 stainless steel electrodes arranged in a circle were placed around the tumor. The applicator was connected to the OMS power supply and six pulseswere administered to each tumor lesion at the approximate point of tavo injection.
16175742|NCT01579305|Device|Juvéderm® Volbella with Lidocaine|Up to 4.0 mL at the discretion of the Investigator to achieve optimal results
16175743|NCT01579305|Device|Restylane-L®|Up to 4.0 mL at the discretion of the Investigator to achieve optimal results
16175744|NCT01579292|Behavioral|Mobile phone based physical activity with intervention|This group will receive a mobile phone software program and a pedometer. Over a 5-month period, participants in this group will be asked to participate in 6 in-person sessions, wear a pedometer, use a mobile phone physical activity and diet diary, and respond to daily physical activity and diet messages or video clips.
16175745|NCT01579292|Behavioral|Pedometer Only|This group will receive a pedometer. Over a 5-month period, participants in this group will be asked to wear a pedometer.
16175746|NCT01579279|Drug|ABT-652 6 mg|6 mg capsules
16175747|NCT01579279|Drug|ABT-652 12 mg|12 mg capsules
16175748|NCT01579279|Drug|ABT-652 12 mg - 18 mg|12 mg - 18 mg capsules
16175749|NCT01579279|Drug|Placebo|Placebo capsules
16175750|NCT01579279|Drug|Duloxetine|Duloxetine capsules
16175751|NCT01579240|Other|Internet exercise program|12 voluntary weekly visits to website
16175752|NCT01579227|Device|Topical Tocotrienol (TCT)|Natural Form Vitamin E topical cream(TCT)
16175753|NCT01579227|Dietary Supplement|Oral Tocotrienol Capsules (TCT)|Natural Form Vitamin E Oral capsules (TCT)
16175754|NCT01579227|Device|Tamoxifen Cream|Tamoxifen cream
16175755|NCT01579227|Device|Placebo cream|Placebo cream
16175756|NCT01579227|Dietary Supplement|placebo capsule|placebo capsule
16175757|NCT01579214|Other|Cellular Phone Text Messages|Cellular phone text message formats to be sent to participants after abnormal laboratory results to communicate information and request early return to clinic.
16175838|NCT01578590|Dietary Supplement|Lean minced meat (beef)|A piece of meat (135 grams, 35 g of protein) or an isonitrogenous-matched milk protein beverage
16175758|NCT01579201|Drug|Carbetocin|First patient: 70 mcg. Following doses according to biased coin design up-down sequential allocation method, with increments or decrements of 10 mcg. An unsatisfactory uterine tone will lead to an increment while a satisfactory uterine tone will result in either a decrement or no change.
16175759|NCT01579188|Drug|GV1001|Intradermal injection 0.84 mg ± 0.084 mg 3 times in Week 1 (Monday, Wednesday, and Friday) and once (Mondays) in Weeks 2, 3, 4, 6, 8, and 10, followed by boost injections given on Weeks 14, 18, 22, 26, and thereafter at 12 week intervals up to Week 98
16175760|NCT01579188|Drug|normal saline|two injections of normal saline injected in the same manner as the experimental drug, GV1001
16175761|NCT01579175|Other|Chewing gum|Sugar Free (Extra spearment) gum given to chew every 4 hours during waking hours for 15 minutes.
16175762|NCT01579162|Device|Cholate-24-13C (IND 65121) & Cholate-2,2,4,4-d4 (IND 65123)|"The FDA has indicated that liver function diagnostic testing with stable isotope labeled cholates would be considered a drug/device combination product. The drugs administered at each test visit will be:
~20 mg Cholate-24-13C, IV (in the vein), dissolved in NaHCO3 and mixed with albumin.
~40 mg Cholate-2,2,4,4-d4, oral, dissolved in NaHCO3 and mixed with juice.
~The 3 test visits will be on separate days within a span of 30 days"
16175763|NCT01579149|Drug|plerixafor|Single subcutaneous (SC) dose of plerixafor (160 μg/kg, 240 μg/kg, or 400 μg/kg),
16175764|NCT01579149|Drug|Placebo|Single subcutaneous (SC) dose of placebo
16175765|NCT01579136|Behavioral|Home blood pressure monitor|The patients using home monitors checked their blood pressure on Monday, Wed, and Friday. They took 2 measurements 5 minutes apart after sitting 5 minutes in the left arm.
16175766|NCT01579123|Procedure|Angioplasty|With angioplasty, a catheter is guided to the portion of the artery that is narrowed or blocked off. A balloon that is attached to the end of the catheter will be inflated which dilates or expands the artery in the area where the narrowing or blockage is located. Based on the angiogram and extent of disease, the physician may place a stent (small mesh tube that is used to treat narrow or weak arteries in the body) during the angioplasty.
16175767|NCT01579123|Procedure|Laser atherectomy|Laser atherectomy uses a catheter that emits high energy light (laser) to unblock the artery. The catheter is moved through the artery until it reaches the blockage. Laser energy is used to essentially vaporize the blockage inside the vessel.
16175768|NCT01579110|Drug|levamisole|"Levamisole 2.5mg/kg(every other day) over six months.
~Prednisone 1mg/kg for two weeks and then tapered off dosage over two months."
16175769|NCT01579110|Drug|Prednisone|Prednisone 1mg/kg for two weeks and then tapered off dosage over two months.
16175770|NCT01579097|Other|Oliclinomel N4|Oliclinomel is a PN product which provides the macronutrients (e.g., dextrose, amino acids, and lipids) for patients when oral or enteral nutrition is not possible, insufficient, or contraindicated
16175771|NCT01579097|Other|Compounded ternary parenteral nutrition admixtures|Study treatment will be administered for a minimum of 5 days up to a maximum of 14 days
16175772|NCT01579084|Drug|AGN-199201 Formulation A|AGN-199201 Formulation A applied to the face as per protocol twice daily.
16175773|NCT01579084|Drug|AGN-199201 Formulation B|AGN-199201 Formulation B applied to the face as per protocol twice daily.
16175774|NCT01579084|Drug|AGN-199201 Formulation C|AGN-199201 Formulation C applied to the face as per protocol twice daily.
16175775|NCT01579084|Drug|AGN-199201 Vehicle|AGN-199201 vehicle (placebo) applied to the face as per protocol twice daily.
16175776|NCT01579071|Procedure|CO2 or room air insufflation during ESD for gastric tumor|CO2 insufflation group : CO2 will be insufflated via the endoscope during procedure as needed, Room air insufflation group : Room air will be insufflated via the endoscope during procedure as needed
16175777|NCT01579058|Drug|bisoprolol|bisoprolol 5mg qd for 4 years
16175778|NCT01579058|Drug|placebo|placebo for 4 years
16175779|NCT01579045|Device|senofilcon A|bilateral daily use soft contact lens
16175780|NCT01579045|Device|etafilcon A|bilateral daily use soft contact lens
16175781|NCT01579045|Device|nelfilcon A|bilateral daily use soft contact lens
16175782|NCT01579045|Device|Filcon II 3|bilateral daily use soft contact lens
16175783|NCT01579045|Device|Filcon II 3|bilateral daily use soft contact lenses
16175784|NCT01579019|Drug|RO5024048|1500 mg po bid, 24 or 26 weeks
16175785|NCT01579019|Drug|RO5024048|1000 mg po bid, 24 or 26 weeks
16175786|NCT01579019|Drug|danoprevir|100 mg po bid, Weeks 1 to 24 or Weeks 3 to 26
16175787|NCT01579019|Drug|peginterferon alfa-2a [Pegasys]|180 mcg sc qw, 24 or 26 weeks
16175788|NCT01579019|Drug|ribavirin [Copegus]|1000 mg or 1200 mg po daily, 24 or 26 weeks
16175789|NCT01579019|Drug|ritonavir|100 mg po bid, Weeks 1 to 24 or Weeks 3 to 26
16175790|NCT01579006|Drug|Tocilizumab|
16175791|NCT01578980|Device|Outpatient Control-to-Range|Subjects will spend two nights (~42 hours) in a local hotel during which the AP Platform will be remotely monitored in an adjacent hotel room for validation that remote system monitoring can successfully occur.
16175792|NCT01578967|Drug|Brentuximab vedotin|IV, 1.8mg/kg, every 3 weeks for 6 cycles.
16175793|NCT01578967|Drug|ABVD|"Doxorubicin - 25mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
~Bleomycin - 10u/m2 IV, Day 1 and 15, every 28 days, 2-6 cycles Vinblastine - 6mg/m2 IV over 3-5 minutes, Day 1 and 15, every 28 days, 2-6 cycles.
~Dacarbazine - 375mg/m2 IV over 30 minutes, Day 1 and 15, every 28 days, 2-6 cycles."
16175794|NCT01578954|Drug|Lenalidomide|"Reinduction/Consolidation - dose escalation of lenalidomide: Level 1 - 25mg, Level 2 - 35mg, Level 3 - 50mg, PO, QD, 28 days.
~Maintenance Lenalidomide - 10mg, PO, QD, continuous dosing, 12 months"
16175795|NCT01578941|Other|Diary|"Each subject will be asked to keep a careful headache diary (appendix B) , and in that diary she will record onset and cessation of menstrual flow, days of menstrual headache (and migraine headache, specifically) experienced, days of functionally incapacitating headache experienced, any abortive/symptomatic medications taken, any days of work-related absenteeism (>4 hrs) related to acute MM headache and any unscheduled visits to a medical facility for acute treatment of MM."
16175796|NCT01578928|Drug|SOM230|
16175797|NCT01578902|Radiation|Stereotactic ablative body radiotherapy|35Gy/5 fractions/29 days
16175798|NCT01578889|Biological|HIV-MAG vaccine|Participants assigned to receive the HIV-MAG vaccine will receive 3 mg of the vaccine with bupivacaine, alone or admixed with one of three doses of the IL-12 pDNA adjuvant.
16178770|NCT01556334|Drug|Erythromycin|Erythromycin IV then PO
16175799|NCT01578889|Biological|IL-12 pDNA adjuvant|Participants assigned to receive the IL-12 plasmid (IL-12 pDNA) adjuvant will receive one of three doses (total of 250 mcg, 1000 mcg, or 1500 mcg) of the adjuvant admixed with the HIV-MAG vaccine.
16175800|NCT01578889|Biological|VSV HIV gag vaccine|Participants assigned to receive the VSV HIV gag vaccine will receive a total dose of 1x10^8 plaque-forming units (PFUs) administered as 5x10^7 PFU in 1 mL by IM injection in both the left and right deltoids at Month 6.
16175801|NCT01578889|Biological|Placebo|Placebo will consist of sodium chloride for injection, USP 0.9%.
16175802|NCT01578889|Device|Ichor Medical Systems TriGrid™ Delivery System (TDS) electroporation (EP) device|The HIV-MAG vaccine, IL-12 pDNA adjuvant, and placebos for IL-12 pDNA adjuvant/HIV-MAG vaccines will be delivered IM into the deltoid by the Ichor Medical Systems TDS EP device.
16175803|NCT01578876|Device|cardiac shock wave therapy(CSWT)|CSWT was performed with the MODULITH SLC SW therapy device (Storz Medical, Switzerland).Shock waves were triggered by the R-wave of the ECG when the instrument was activated. The shock wave energy was increased from an initial low level up 0.09 mJ/mm2 if the patient experienced no discomfort such as chest pain. Point-to-point combination treatment for the ischemic areas with 200 pulses delivered to each point was given.
16175804|NCT01578863|Other|Intervention program for obese children|The program includes physical activity, nutrition intervention and behavioral treatment and lasts for 6 months. The aim of the program is to promote weight loss and physical activity and to promote future healthy lifestyle.
16175805|NCT01578850|Drug|Etanercept|etanercept 50mg once weekly + methotrexate with or without other DMARDs
16175806|NCT01578850|Drug|placebo|etanercept placebo once weekly + methotrexate with or without other DMARDs
16175807|NCT01578837|Dietary Supplement|Ginseng|2.25g of encapsulated ginseng (1.5g American Ginseng and 0.75g Rg3-enriched Korean Red Ginseng)will be administered in 6 identical capsules, 2 capsules with each meal (total 6 capsules per day).
16175808|NCT01578837|Dietary Supplement|Wheat Bran|2.25g of encapsulated 100% natural wheat bran will be administered in 6 identical capsules, 2 capsules with each meal (total 6 capsules per day).
16175809|NCT01578824|Other|Methacholine Challenge Test|Evaluation of airway hyperreactivity as assessed by doubling dose of methacholine with determination of PC20
16175810|NCT01578811|Drug|Placebo|Dosage
16175811|NCT01578811|Drug|SK-MS10|Dosage
16175812|NCT01578811|Drug|SK-MS10|Dosage
16175813|NCT01578785|Drug|Glatiramer Acetate|Glatiramer acetate 20mg in 0.5ml for subcutaneous injection in a pre-filled syringe (PFS) is administered daily. Each PFS also contains 20mg mannitol dissolved in water for injection.
16175814|NCT01578785|Drug|Placebo|Matching placebo injection; 20 mg mannitol dissolved in 0.5 mL water for subcutaneous injection in a PFS is administered daily.
16175815|NCT01578772|Drug|Telmisartan|80mg tablets po daily for 6 weeks
16175816|NCT01578759|Procedure|Salpingectomy|Removal of the fallopian tubes
16175817|NCT01578746|Procedure|Direct lateral approach in total hip arthroplasty|The use of direct lateral approach in total hip arthroplasty
16175818|NCT01578746|Procedure|Anterior approach|The use of anterior approach in total hip arthroplasty
16175819|NCT01578733|Dietary Supplement|protein intake.|•Protein intakes will be varied at 0.2, 0.5, 0.7, 0.9,1.0, 1.2, 1.5, 1.8g, 2.0g/kg/day
16175820|NCT01578720|Drug|EYLEA (Aflibercept) intravitreal injection|Intravitreal Injection once every 8 weeks with 3 initial monthly doses
16175821|NCT01578707|Drug|ofatumumab|"The ofatumumab (IV) dosage and schedule is 12 doses administered over 24 weeks or until disease progression, unacceptable toxicity.
~Week 1: 300 mg initial dose Week 2 through 8: 2,000 mg (once weekly) Week 12, 16, 20 and 24: 2,000 mg (every 4 weeks)"
16175822|NCT01578707|Drug|ibrutinib|ibrutinib 420 mg (3 x 140-mg capsules) will be administered orally once daily until disease progression or unacceptable toxicity
16175823|NCT01578694|Diagnostic Test|Magnetic Resonance Imaging (MRI)|T1 rho MRI is a modified pulse sequence from the standard T1 sequence used in the clinical MRI.
16175824|NCT01578681|Procedure|Low Expiration Open glottis inferolateral (ELTGOL)|Place the affected lung in infralateral, asks the patient to make an inspiration without being forced to medium volume, and then a slow expiration with the glottis open, down to residual volume. If the therapist is present place the abdominal caudal hand at putting pressure cranial head and hand is placed over the rib cage at a pressure of closing the rib cage. Otherwise, the patient self-administered intertwining arms and abdominal rib at top exerting the same pressure. In case you have two lungs affected the art will take place on one side and then the opposite.
16175825|NCT01578681|Procedure|Stretching|Patient will be instructed to do muscle stretching of the thorax
16175826|NCT01578668|Drug|erlotinib|150 mg given orally (po), daily (QD), starting on the 4th day of each cycle, ending on the 21th day before the next cycle, and until disease PD
16175827|NCT01578668|Drug|pemetrexed|500 mg/m² intravenous (iv) over 15 minutes on the first day of each 21-day cycle until disease progression (PD) or unacceptable toxicity or no more than 6 cycles
16175828|NCT01578668|Drug|cisplatin|cisplatin 20mg/m² iv on the 1st-3rd day (if PS<2) or 30 mg iv on the 1st-2nd day (if PS=2 or 3)of each cycle until PD or unacceptable toxicity or no more than 6 cycles
16175829|NCT01578668|Drug|erlotinib|150 mg given orally (po), daily (QD), starting on the first day of the first cycle
16175830|NCT01578655|Drug|cabazitaxel|Cabazitaxel (25mg/m² IV) is administered on day 1 of each 21-day cycle until disease progression, unacceptable toxicity, or completion of 10 cycles
16175831|NCT01578655|Drug|prednisone|Prednisone (10 mg PO) is administered daily until disease progression, unacceptable toxicity, or completion of 10 cycles
16175832|NCT01578655|Drug|custirsen sodium|Custirsen is administered as 3 loading doses (640 mg IV each) within 9 days, followed by weekly custirsen (640 mg IV) during each 21-day cycle until disease progression, unacceptable toxicity, or completion of 10 cycles
16175833|NCT01578642|Device|EndoStim LES Stimulation System|"The EndoStim LES Stimulation System comprises three components:
~an electrical stimulation lead an implantable pulse generator (IPG) and an external programmer."
16175834|NCT01578629|Other|Vitamin E tocotrienol (TCT) capsules ; Low dose Aspirin|Vitamin E TCT capsules- 400-800 mg Aspirin- 81 mg
16175835|NCT01578629|Other|Placebo vehicle control|vehicle control compared to Vitamin E TCT pills
16175836|NCT01578603|Dietary Supplement|xylitol|6 g/day, for a month, by chewing 2g three times daily after meals.
16179909|NCT01547273|Procedure|no bone graft|no bone graft
16175839|NCT01578577|Behavioral|EHMI|The EHMI intervention consists of multiple components, all leveraged by the Epic EHR platform (Verona, WI). The EHMI intervention 1) activates patients to review their medication list and identify any adherence-related concerns, 2) automates a process for providing plain language, patient-centered print medication information for new and refilled prescriptions, and 3) provides additional print tools to help patients more effectively engage their providers, consolidate their regimen, and generally promote safe use and adherence.
16175840|NCT01578577|Behavioral|Nurse Educator + EHMI|This intervention is a combination of the use of a nurse educator and the EHMI tools described in the EHMI intervention arm. A nurse educator perform the following: 1) perform medication and medical record review 2)assess adherence and medication problems 3) provide counseling to promote safe and effective medication use 4) follow-up with patients after their visit to confirm they have filled all prescriptions, and can accurately teach back their medicine regimen, 5) communicate with prescribing physician when problems are identified.
16175841|NCT01578564|Drug|SOR-C13|Intravenous solution for infusion, potential dose range 1.375 mg/kg to 6.12 mg/kg, dosing frequency 2 cycles with a cycle consisting of infusions on days 1-3 and days 8-10 followed by a 11 day off period
16175842|NCT01578551|Drug|Paclitaxel|200 mg/m² IV over 3 hours, day 1 of each cycle. Paclitaxel + Carboplatin + Bevacizumab will be administered once every 21 days (Day 1) for up to 6 cycles. If subject has complete response, partial response, stable disease, or unacceptable toxicity. Bevacizumab with Metformin (Arm A) or Bevacizumab alone (Arm B) may continue as maintenance therapy.
16175843|NCT01578551|Drug|Carboplatin|"Carboplatin is administered at AUC= 6 mg/ml X min IV over 15-30 minutes, immediately following Paclitaxel infusion every 21 days
~Paclitaxel + Carboplatin + Bevacizumab will be administered once every 21 days (Day 1) for up to 6 cycles. If subject has complete response, partial response, stable disease, or unacceptable toxicity. Bevacizumab with Metformin (Arm A) or Bevacizumab alone (Arm B) may continue as maintenance therapy"
16175844|NCT01578551|Drug|Bevacizumab|All patients will receive the drug at 15 mg/kg every 21 days, given immediately after completion of chemotherapy, starting with Cycle 1. After induction chemotherapy is completed (4 cycles), bevacizumab will continue at 15 mg/kg every 21 days until PD (provided neither PD nor toxicity requiring discontinuation has occurred) measured from date of first dose of bevacizumab.
16175845|NCT01578551|Drug|Metformin|1000 mg twice daily with food.
16175846|NCT01578538|Procedure|inguinal hernia repair|strangulated hernias will be repaired surgically
16175847|NCT01578525|Other|Pharmaceutical Care Service|Checking medication under safety considerations (medication at admission, hospitalization, discharge); recommendations for potentially inappropriate medication (PRISCUS-criteria),
16175848|NCT01578512|Behavioral|Face-to-Face|Face-to-Face behavioral weight loss
16175849|NCT01578512|Behavioral|Web-based|Web-based behavioral weight loss
16175850|NCT01578512|Behavioral|Single session|The core of behavioral weight loss, including calorie and activity prescriptions, are delivered in a single group treatment session.
16175851|NCT01578499|Drug|Brentuximab Vedotin|Brentuximab vedotin intravenous injection.
16175852|NCT01578499|Drug|Methotrexate|Methotrexate tablets.
16175853|NCT01578499|Drug|Bexarotene|Bexarotene tablets.
16175854|NCT01578486|Drug|salsalate|open-label trial of salsalate 3g/day for 12 weeks.
16175855|NCT01578473|Drug|Vitamin D2|oral softgel 2000 IU once daily 9 months
16175856|NCT01578473|Drug|Vitamin E|"oral softgels 400 IU and 200 IU 1 softgel of 400 IU daily
~1 softgel of 200 IU daily 9 months"
16175857|NCT01578473|Drug|Testosterone Pellets|subcutaneous implantation pellets 75 mg based on testosterone levels from resulting bloodwork 9 months
16175858|NCT01578460|Device|Continuous Glucose Monitoring|Participants in the CGM group will be asked to monitor their blood glucose for 5 days for the 28th, 32nd and 36th week of gestation using the iPro2 CGM.
16175859|NCT01578460|Device|Glucose Meter|Participants in the control group will be asked to monitor their blood glucose for 5 days for the 28th, 32nd and 36th week of gestation using a glucose meter.
16175860|NCT01578447|Drug|DepoSubQ Provera 104 in Uniject|DepoSubQ Provera 104 in Uniject
16175861|NCT01578447|Drug|Intramuscular DMPA|Intramuscular DMPA
16175862|NCT01578434|Drug|Vitamin D|Vitamin D: 6 lakh IU single im dose Calcium: 75 mg/kg calcium daily for 3 months vitamin D and Calcium: combination of above two
16175863|NCT01578434|Drug|Calcium Carbonate|Calcium: 75 mg/kg calcium daily for 3 months
16175864|NCT01578434|Drug|Vitamin D and Calcium|Vitamin D: 6 lakh IU single im dose. along with Calcium: 75 mg/kg calcium daily for 3 months
16175865|NCT01578421|Device|4 h online hemodiafiltration (FX 100, Polyflux 210, FXCorDiax)|4 h online hemodiafiltration with measurement of clearance and removal rate by split dialysate collection and bloodside measurements
16175866|NCT01578408|Procedure|Total Hip Arthroplasty|
16175867|NCT01578408|Device|Cemented Lubinus SPII stem (control arm)|Cemented Lubinus femoral stem. Cemented IP acetabular cup. (Link).
16175868|NCT01578408|Device|Uncemented HA Coated Corail stem|Uncemented hydroxyapatite coated Corail femoral stem. Cemented Marathon acetabular cup. (DePuy).
16175869|NCT01578395|Radiation|Low-dose radiation exposure|what: Cardiac CT; dosage: approx. 2-3 mSv; frequency: once
16175870|NCT01578395|Radiation|High-dose radiation exposure|what: cardiac catheterization procedures; dosage: approx. 75 mSv; frequency: once
16175871|NCT01578395|Other|No radiation exposure|Subjects not undergoing any radiation exposure
16175872|NCT01578369|Other|Exercise classes with pelvic floor muscle training|Supervised exercise classes which included pelvic floor muscle training. 3 sessions per week. 55-60 min per session, with 10 minutes of pelvic floor muscle training. At least during 22 weeks.
16175873|NCT01578343|Drug|Fludarabine, Mitoxantrone, Dexamethasone, Vorinostat|"Induction treatment (Total 4 cycles) FND D1-3 Fludarabine 25mg/m2 + NS 100mL iv over 30 min D1 Mitoxantrone 10mg/m2 + NS 100mL iv over 30 min D1-5 Dexamethasone 20mg IV or PO every 4 weeks Vorinostat D1-10 Vorinostat 200mg once daily PO (When vorinostat is concurrently administered with FND regimen, vorinostat will be administered 3 hours before chemotherapy)
~Consolidation treatment for responders Patients not eligible for transplantation
~Vorinostat maintenance up to 6 cycles
~200mg twice daily for 14 consecutive days from D1 - 14 in a 21 day cycle
~Delay of the start of the next cycle by up to 7 days will be acceptable.
~If relapse or progression during maintenance, it will be stopped. Patients eligible for transplantation
~High-dose chemotherapy followed by autologous stem cell transplantation"
16175874|NCT01578330|Drug|Fingolimod|Fingolimod 0.5mg orally once a day without food.
16175875|NCT01578317|Biological|H5N1 vaccine plus AS03 adjuvant|H5N1 influenza vaccine with AS03 at the 3.75 mcg dose level given 21 days apart.
16175876|NCT01578317|Biological|H5N1 vaccine without adjuvant|H5N1 influenza vaccine non- adjuvanted form at the 3.75 mcg dose level given 21 days apart.
16175877|NCT01578304|Drug|Imidafenacin|Tablet, 12 weeks twice daily
16175878|NCT01578304|Drug|Fesoterodine|Tablet, 12 weeks once daily
16175879|NCT01578291|Behavioral|Parental information|An informational brochure indicating the study details
16175880|NCT01578291|Behavioral|Play therapy|Play therapy with a child life specialist
16175881|NCT01578278|Drug|Bepotastine besilate formulation|Nasal Spray
16175882|NCT01578278|Drug|Fluticasone propionate|Nasal Spray
16175883|NCT01578278|Drug|Bepotastine besilate-fluticasone propionate|Nasal Spray
16175884|NCT01578278|Drug|Placebo Comparator|Nasal Spray
16175885|NCT01578265|Drug|Ondansetron Tablets USP 8 mg|8 mg tablet once a day
16175886|NCT01578265|Drug|Ondansetron Hydrochloride|8 mg tablet once a day
16175887|NCT01578252|Drug|Ondansetron Tablets USP 8 mg|8 mg tablet once a day
16175888|NCT01578252|Drug|Ondansetron Hydrochloride|8 mg tablet once a day
16175889|NCT01578239|Drug|Octreotide LAR|"In the experimental arm, 30 mg Octreotide LAR treatment was given to the participants until the end of study for symptom control purpose, unless the participant progressed or died.
~In the active comparator arm, 60 mg Octreotide LAR treatment was given to the participants every 4 weeks (i.m. injections) until the end of the study, unless the participant progressed or died."
16175890|NCT01578239|Drug|177Lu-DOTA0-Tyr3-Octreotate|Four administrations of 7.4 GBq (200 mCi) 177Lu-DOTA0-Tyr3-Octreotate administered at 8 +/- 1-week intervals, which could be extended up to 16 weeks to accommodate resolving acute toxicity.
16175891|NCT01578213|Drug|Imatinib mesylate|"Capsules, hard 50 or 100 mg/Film-coated Tablets 100 or 400 mg
~Total dosage per day: 800 mg
~Oral use"
16175892|NCT01578200|Drug|Lanthanum Carbonate|
16175893|NCT01578200|Drug|Calcium Carbonate|
16175894|NCT01578187|Device|Hair2Go|Treatment with the device once under observation
16175895|NCT01578174|Drug|Dexmedetomidine|Dexmedetomidine(Dexmedetomidine 2 mL and normal saline 98 mL mixed -> 2㎍/mL) : the infusion of 0.2㎍/kg/hr is started at 30 minutes before the procedure and the infusion dose is raised to 0.4㎍/kg/hr after completion of procedure
16175896|NCT01578174|Drug|Normal saline 0.9%|Normal saline 100mL(guess as 2㎍/mL):the infusion of 0.2㎍/kg/hr is started at 30 minutes before the procedure and the infusion dose is raised to 0.4㎍/kg/hr after completion of procedure
16175897|NCT01578161|Drug|Dexmedetomidine|There are four groups accoding to dosage of dexmedetomidine. Dexmedetomidine 0.25 microg.kg(-1),(group D0.25), dexmedetomidine 0.5 microg.kg(-1),(Group D0.5), dexmedetomidine 1 microg.kg(-1) (Group D 1) and normal saline(group P) is administered ivs. for 10mins when we are inducing each patient.
16175898|NCT01578161|Drug|0.9% Normal Saline|Placebo,Normal saline 10ml ivs. for 10min.
16175899|NCT01578148|Procedure|Noxipoint Therapy|"Patients will be treated with a TENS device, following Noxipoint Therapy guidelines:
~Find the cause of the pain via Noxipoint: For each injured muscle/tissue, it is discovered that there are always a pair of points at the skin surface locations of its nociceptors that are painful at light press (named Noxipoints).
~Stimulate the corresponding pair of Nocipoints following a narrowly defined combination of intensity/ frequency (inducing the C-fiber response) and duration (about 1.5-3 minutes) of TENS at the two targeted Noxipoints.
~Repeat (a) to (b) above for each identified injured muscle group until all pain areas are eliminated or when the session time is up.
~Instruct the subject not to use the newly recovered muscle/tissue too much an estimated rest period depending on his/her age."
16175900|NCT01578148|Procedure|Physical Therapy|"The 1.5-hour physical therapy in the control arm are provided both as standard of care and sham device comparison to Nocipoint Therapy, following these guidelines:
~TENS stimulation (45 minutes):
~• Electrodes will be placed around the patient-identified general pain area on the neck /shoulder for TENS. Rotate the electrode pads around the pain area and stimulate again.
~Other modalities of PT per the therapist's choice:
~Infrared treatment on the pain areas (about 15 minutes)
~Manual therapy to cervical and/or rotator cuff areas (about 15 minutes).
~Exercise and training:
~Neck exercises: Range of motion exercises to include foraminal opening for about 15 minutes, and/or
~Shoulder exercise: Range of motion exercises to include walking the arm on the wall, rotation of the upper arm for about 15 minutes
~Hot/cold pack to the pain area for about 15 minutes"
16175901|NCT01578135|Drug|somatropin|Patients are to fill in a questionnaire at inclusion in registry
16175902|NCT01578135|Drug|somatropin|Patients are to fill in a questionnaire 6 months after inclusion into registry and then annually until adult height is reached
16175903|NCT01578122|Device|25mmHg ECS|"Thigh-length graduated elastic compression stockings applying 25 mmhg of targeted pressure at the ankle worn daily (from morning to night) for two years.
~Before receiving the randomly allocated treatment, each patient will wear cotton, class III Varisma Comfort® stay-up stockings (20-36 mm Hg)."
16175904|NCT01578122|Device|35 mmHg ECS|Thigh-length graduated elastic compression stockings applying 35mmhg of pressure at the ankle worn daily (from morning to night) for two years Before receiving the randomly allocated treatment, each patient will wear cotton, class III Varisma Comfort® stay-up stockings (20-36 mm Hg).
16175905|NCT01578109|Procedure|Bone Marrow Transplantation|Undergo BMT
16175906|NCT01578109|Drug|Sorafenib|Given PO
16175907|NCT01578109|Drug|Sorafenib Tosylate|Given PO
16175908|NCT01578096|Behavioral|stress management|The study is a randomized, controlled,single-site, parallel group clinical trial comparing the effectiveness of CHW led diabetes education with CHW led diabetes education plus CHW led stress management in Latinos with Type 2 Diabetes.
16175909|NCT01578070|Biological|0.2μg Act-HIB®|0.2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
16175910|NCT01578070|Biological|ViscoGel® and 0.2μg Act-HIB®|Pre-selected dose of ViscoGel® (from phase A) and Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
16175911|NCT01578070|Biological|ViscoGel® and 2μg Act-HIB®|Pre-selected dose of ViscoGel® (from phase A) and 2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
16175912|NCT01578070|Biological|2μg Act-HIB®|2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
16175943|NCT01577849|Drug|DP-R206|administration of DP-R206 (150mg ibandronate / 24,000IU Vitamin D3)
16175913|NCT01578070|Biological|10μg Act-HIB®|Clinical standard dose of 10μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
16175914|NCT01578057|Drug|tasimelteon|20mg, once
16175915|NCT01578057|Drug|Ethanol|0.6 g/kg ethanol (women) or 0.7 g/kg ethanol (men) in a total volume of 300 mL as a light cranberry juice cocktail, (consumed within 15 minutes).
16175916|NCT01578057|Other|Placebo tasimelteon|once
16175917|NCT01578057|Drug|Placebo ethanol|A total volume of 300 mL as a light cranberry cocktail (consumed within 15 minutes) with about 1 mL of supernatant of ethanol in the top
16175918|NCT01578044|Behavioral|Intervention|"Patient education: Patients will receive information on dabigatran, including risks, benefits and potential side effects. This information will be re-enforced during the study on a monthly basis during the IVR calls and during the pharmacy service calls to patients.
~Tele-monitoring: We will use IVR technology to send patients an automated reminder to refill their dabigatran, rivaroxaban, and apixaban prescriptions. This call will be delivered on day 20 following each dabigatran, rivaroxaban, and apixaban prescriptions.
~Pharmacists follow-up: If dabigatran, rivaroxaban, and apixaban have not been refilled, the pharmacy staff will contact the patient to assess reasons that the patient has not refilled the medication."
16175919|NCT01578044|Other|Control|Usual care
16175920|NCT01578031|Device|Positive Airway Pressure During Sleep (ResMed S9 Elite)|Positive airway pressure during sleep (ResMed S9 Elite).
16175921|NCT01578031|Other|Usual Care|Usual care.
16175922|NCT01578018|Other|Measure DCAM levels in blood|Measure DCAM levels in blood
16175923|NCT01578018|Other|DCAM levels in blood|DCAM levels in blood
16175924|NCT01577992|Drug|Levodopa test|Each patients with PD and MSA will be evaluated in two conditions : OFF (without dopaminergic treatment since 12h) and ON condition (after a L-DOPA dose. This dose will be 150% of the DOPA morning dose. The healthy volunteers will be evaluated in only one condition (without L-DOPA administration)
16175925|NCT01577992|Procedure|determination of objective and subjective pain threshold|Test without levodopa intake
16175926|NCT01577979|Behavioral|Text Message Reminder/Recall|Adolescents will be randomly selected from the participating private practices and safety net organization clinics. Parents of selected adolescents will receive a text message to alert them that their child is due for a vaccine or well-care visit. The text message will provide response instructions. The responses can be one of three options: 1) the parent will call the clinic to schedule a visit, 2) the parent would like the clinic to call them to schedule a visit, or 3) the parent would like to stop any future text message reminders. Parents who would like the clinic to call them to schedule an appointment will be contacted by their child's provider to set up a visit. Parents may receive up to 3 text message reminders, unless they chose to stop any future messages.
16175927|NCT01577979|Behavioral|Parent Preference|Parents of adolescents being seen within the managed care organization's intervention clinics will be asked about their reminder method preference at their child's 1st HPV immunization. The preference options include phone call, text message, or email. The preference for contact method will be recorded and utilized for the 2nd and 3rd dose reminders. The clinics' usual method of reminder will be used for all other parents.
16175928|NCT01577966|Drug|Sulfasalazine|"Sulfasalazine has been the parent aminosalicylate in use for over 40 years in the treatment of inflammatory bowel disease. The drug is a conjugate of sulfapyridine linked to 5-aminosalicylic acid. In inflammatory bowel disease, the 5-ASA component is the active moiety
~Sulfasalazine is a prodrug that consists of sulfapyridine bonded to mesalamine (5-ASA). Sulfasalazine is cleaved by colonic bacterial azo-reductases into sulfapyridine and the 5-ASA moiety. 5-ASA is metabolized to N-acetyl-5-ASA by an enzyme in the intestinal epithelium and the liver and then excreted in the urine as a mixture of free 5ASA and N-acetyl-5-ASA."
16175929|NCT01577953|Drug|SB010|"Three consecutive ascending dose groups (A, B, and C) are planned, with a total of 24 patients with asthma. Each dose group will consist of 8 patients (n=6 receiving active drug and n=2 receiving placebo). Each patient will participate in one dose group only.
~Dose escalation to the second and third dose level will occur after satisfactory review of safety and tolerability and after review of the pharmacokinetic data (exposure control, up to 4 hours after administration) of the preceding dose group by the Safety Board.
~Dose levels:
~Dose group A: 5 mg hgd40 in 2 mL solution (concentration: 2.5 mg/mL); Dose group B: 10 mg hgd40 in 2 mL solution (concentration: 5.0 mg/mL); Dose group C: 20 mg hgd40 in 2 mL solution (concentration: 10.0 mg/mL)."
16175930|NCT01577953|Drug|Placebo|"Three consecutive ascending dose groups (A, B, and C) are planned, with a total of 24 patients with asthma. Each dose group will consist of 8 patients (n=6 receiving active drug and n=2 receiving placebo). Each patient will participate in one dose group only.
~Dose escalation to the second and third dose level will occur after satisfactory review of safety and tolerability and after review of the pharmacokinetic data (exposure control, up to 4 hours after administration) of the preceding dose group by the Safety Board."
16175931|NCT01577940|Procedure|Infusion of ropivacaine|TAP block with ropivacaine 20 ml 0,5%. Catheter with infusion of ropivacaine 0,2% 5 ml/h 24 hours on one side of the abdomen.
16175932|NCT01577940|Procedure|Infusion of saline|TAP block with ropivacaine 0,5% 20 ml. Catheter with infusion of saline 5 ml/h 24 hours.
16175933|NCT01577927|Other|Usual home care|Usual home care consists in supporting drug and oxygen therapy, mechanical ventilation, GP's assistance,and periodical in-hospital visit.
16175934|NCT01577927|Behavioral|PT-assisted home rehabilitation|"Patient performs 50 min physical activity/working day autonomously by the help of a DVD. The physical activity consists in cyclette, calisthenic exercises, and training of the respiratory muscles.
~Every two weeks, PT phones the patient for an educational reinforcement."
16175935|NCT01577914|Drug|Carvedilol Tablets USP 12.5 mg|12.5mg tablet once a day
16175936|NCT01577914|Drug|Carvedilol|12.5mg tablet once a day
16175937|NCT01577901|Other|Clearblue Advanced|Pregnancy test
16175938|NCT01577888|Device|Shockwave System Treatment|Shockwave System Treatment during vascular disease intervention.
16175939|NCT01577875|Device|NBI with magnification|After randomization of the subjects into two groups(1) NBI with magnification, 2) without magnification), one experienced endoscopist records its site, size, shape, and predicted histologic diagnosis on the every polyp observed and endoscopically resected. Two groups will be compared with each other.
16175940|NCT01577862|Drug|Colistin|2 million units every 8 hours intravenously for at least 10 and up to a maximum of 21 days
16175941|NCT01577862|Drug|Rifampicin|600 mg every 12 hours intravenously
16175942|NCT01577849|Drug|Vitamin D3|administration of Vitamin D3 24,000 IU
16175945|NCT01577810|Device|Near Infrared Spectroscopy|Use of Near Infrared Spectroscopy in outpatient setting to determine global cardiac output
16175946|NCT01577797|Behavioral|Text messages|Messages sent at random intervals 4 times per day during weeks 1 and 3. Subjects can also request messages if they are craving methamphetamine
16175947|NCT01577784|Drug|Pazopanib|800 mg / day of pazopanib in monotherapy.
16175948|NCT01577771|Biological|Prevnar13 (manufactured by Pfizer)|Prevnar13 administered IM in the antero-lateral thigh
16175949|NCT01577758|Drug|MLN0264|MLN0264 30-minute infusion on Day 1 of each treatment cycle
16175950|NCT01577745|Biological|MEDI0639|MEDI0639 is an immunoglobulin G1 lambda (IgG1λ) monoclonal antibody. MEDI0639 selectively binds to DLL4 and blocks its ability to bind to and activate signaling through the Notch receptors.
16175951|NCT01577732|Biological|Infanrix-IPV+Hib™|Single dose administered intramuscularly (IM) into the anterolateral side of the right thigh.
16175952|NCT01577719|Behavioral|Multimedia Lifestyle Improvement|"Online Goal setting to improve diet, physical activity or smoking behaviours
~regular health messaging related to the participant's goal, sent by email or text messaging, based on participant preference.
~Bi-weekly email reminder to report back on the current lifestyle goal and choose the next goal for upcoming 2 weeks."
16175953|NCT01577719|Behavioral|Usual Care|Participant will be refered to SAHARA study website to get information on healthy lifestyle and to get regular update for the course of follow-up.
16175954|NCT01577706|Drug|Alprazolam|Alprazolam, gel-capsule, 1mg, single-dose, 1-day
16175955|NCT01577706|Drug|Dextroamphetamine|Dextroamphetamine, gel-capsule, 20mg, single-dose, 1-day
16175956|NCT01577706|Other|Placebo|Placebo, gel-capsule, single-dose, 1-day
16175957|NCT01577693|Drug|dutasteride|novel dutasteride
16175958|NCT01577693|Drug|dutasteride|dutasteride soft gel capsule
16175959|NCT01577680|Drug|Inhaled GSK573719/vilanterol|All subjects will receive a single dose of GSK573719/VI (125mcg/25mcg) in Treatment Period 1
16175960|NCT01577680|Drug|Inhaled GSK573719|All subjects will receive GSK573719 (125mcg) once daily for seven days in Treatment Period 2
16175961|NCT01577667|Device|Intellivent; automatic mode implemented on a S1 ventilator|Intellivent allows an automatic adjustment of the following parameters: FiO2, PEEP and %VM according to adjusted parameters: Size, SpO2 and EtCO2
16175962|NCT01577654|Drug|EC145|2.5 mg on Days 1,4,8,11 (Weeks 1 and 2 q3 weeks)
16175963|NCT01577654|Drug|EC145 + Docetaxel|"EC145 2.5 mg on Days 1,4,8,11 (Weeks 1 and 2 q3 weeks) +
~Docetaxel 75 mg/m2 IV Day 1 q 3 weeks"
16175964|NCT01577654|Drug|Docetaxel|75 mg/m2 IV Day 1 q 3 weeks
16175965|NCT01577654|Drug|EC20|During the screening period participants will receive a single intravenous administration of EC20 prior to SPECT imaging
16175966|NCT01577628|Drug|Lipikar Balm AP|Daily application of Lipikar Balm AP starting at birth
16175967|NCT01577615|Behavioral|Patterned Experience|"The caregiver's hand over the shoulder area and the other hand over the lower extremities during feeding in the incubator, swaddling or holding outside the incubator.
~Nonnutritive sucking will be offered to infants.
~Blood work will be collected for inflammatory cytokines.
~Saliva will be collected for genetic analysis
~Saliva will be collected in 10 infant sub study for cortisol pre and post feedings
~All scheduled feedings will include an opportunity for the infant to try feeding orally by bottle or breast while being held in a swaddled flexed position.
~Once bottle feedings are initiated, infants will be observed twice a week utilizing the computer data acquisition system.
~Follow up visits will occur at 2,6and 24 months corrected age."
16175968|NCT01577602|Other|Printed medication list|Provide a list of patient's current medication list as noted in the EMR
16175969|NCT01577602|Other|Open ended question|medical assistants begin medication reconciliation with a scripted open ended question.
16175970|NCT01577602|Other|Combined intervention|Combines the printed medication list with the open ended question
16175971|NCT01577589|Drug|600 mg ceftaroline fosamil in 50 ml infusion volume|IV infusion
16175972|NCT01577589|Drug|Placebo in 50 ml infusion volume|IV infusion
16175973|NCT01577589|Drug|600 ceftaroline fosamil in 250 ml infusion volume|IV infusion
16175974|NCT01577589|Drug|Placebo in 250 ml infusion volume|IV infusion
16175975|NCT01577589|Drug|600 mg ceftaroline in 100 ml infusion volume|IV infusion
16175976|NCT01577589|Drug|Placebo in 100 ml infusion volume|IV infusion
16175977|NCT01577550|Drug|BI 655066 (very high i.v. dose)|Single very high i.v. dose BI 655066
16175978|NCT01577550|Drug|Placebo, i.v.|Single i.v. administration of placebo
16175979|NCT01577550|Drug|BI 655066 (high s.c. dose)|Single high s.c. dose BI 655066
16175980|NCT01577550|Drug|BI 655066 (low i.v. dose)|Single low i.v. dose BI 655066
16175981|NCT01577550|Drug|BI 655066 (high medium i.v. dose)|Single high medium i.v. dose BI 655066
16175982|NCT01577550|Drug|BI 655066 (very low i.v. dose)|Single very low i.v. dose BI 655066
16175983|NCT01577550|Drug|BI 655066 (low s.c. dose)|Single low s.c. dose BI 655066
16175984|NCT01577550|Drug|BI 655066 (high i.v. dose)|Single high i.v. dose BI 655066
16175985|NCT01577550|Drug|Placebo, s.c.|Single s.c. administration of placebo
16175986|NCT01577550|Drug|BI 655066 (low medium i.v. dose)|Single low medium i.v. dose BI 655066
16175987|NCT01577537|Drug|1% SPL7013 Gel|Vaginal gel, daily for 7 days
16175988|NCT01577537|Drug|Placebo|Vaginal gel, daily for 7 days
16175989|NCT01577524|Drug|Povidone-Iodine|Subjects in the treatment group will receive 3.5% diluted Povidone Iodine solution in the surgical incision in a quantity sufficient to fill the wound to the level of the skin. The Povidone Iodine solution will be maintained in the incision for 3 minutes, after which it will be flushed from the wound with normal saline solution.
16175990|NCT01577524|Drug|Saline|Subjects in the Placebo Comparator group will receive normal saline solution in a quantity sufficient to fill the wound to the level of the skin. The saline solution will be maintained in the incision for 3 minutes, after which it will be flushed from the wound with additional saline solution to replicate the saline wash procedure followed in the Treatment group.
16175991|NCT01577511|Biological|Samples and follow up|"Samples: Peroperative blood sample plus primary and metastatic tumor biopsies.
~Follow-up: disease outcomes assessed at 24 months"
16175992|NCT01577485|Dietary Supplement|Probiotics in an pastille|Test group
16175993|NCT01577485|Dietary Supplement|Control pastille|Control group
16175994|NCT01577472|Drug|High Dose Clomiphencitrat|100mg of clomiphencitrate(Serophene®) are added to a high dose of HMG (450 IU of Merional®) in the early follicular phase of the stimulation (day 3 to 7).
16175995|NCT01577472|Drug|Low Dose Clomiphencitrat|100mg of clomiphencitrate(Serophene®) are added to a low dose of HMG (150 IU of Merional®) in the early follicular phase of the stimulation (day 3 to 7).
16175996|NCT01577472|Drug|High Dose Placebo|Placebo is added to a high dose of HMG (450 IU of Merional®) in the early follicular phase of the stimulation (day 3 to 7).
16175997|NCT01577472|Drug|Low dose Placebo|Placebo is added to a low dose of HMG (150 IU of Merional®) in the early follicular phase of the stimulation (day 3 to 7).
16175998|NCT01577459|Drug|TR-701 FA with PSE|TR-701 FA Oral 200 mg oral with PSE
16175999|NCT01577459|Other|TR-701 FA Placebo with PSE|TR-701 FA Placebo Oral 200 mg with PSE
16176000|NCT01577446|Procedure|cardiac resynchronization therapy|Implantation of a CRT defibrillator with a standard right atrial, right ventricular defibrillator and left ventricular leads
16176001|NCT01577420|Other|Reflexology Sessions|One session per week performed by certified reflexologist for four consecutive weeks.
16176002|NCT01577420|Other|Placebo Sessions|One session per week performed by research aide for four consecutive weeks.
16176003|NCT01577407|Drug|Nefopam|Subjects will be infused intravenously with nefopam (20mg/2mL) over a course of 30 minutes in a supine position. There will be a single administration of IV 20 mg nefopam and IV placebo. Each intervention will occur on a separate day.
16176004|NCT01577394|Other|oculomotor measurements|"The variability is indicated by the coefficient of variation (i.e. standard-error/mean) of saccades latencies in the gap paradigm.
~Mean reflexive saccades latency Percentage of express saccades"
16176005|NCT01577381|Biological|RN6G|Intravenous, 11 doses, 30 minute infusion, dose ranging from 2.5 mg/kg up to a maximum of 15 mg/kg
16176006|NCT01577381|Biological|Placebo|Intravenous, 11 doses, 30 minute infusion
16176007|NCT01577368|Drug|Piperacillin-Tazobactam continuous infusion|Piperacillin-Tazobactam 2gr (Loading dose DAY 1) plus Piperacillin-Tazobactam continuous infusion 8gr every 24 hours (DAY 1-14)
16176008|NCT01577368|Drug|Piperacillin-Tazobactam intermittent infusion|Piperacillin-Tazobactam intermittent infusion 4gr every 8 hours (DAY 1-14)
16176009|NCT01577355|Radiation|Drug|Single 30 mg oral dose containing 100 micro curies of LY2784544
16176010|NCT01577342|Drug|Moxifloxacin 0.5%|1 drop 4 times daily times 3 days post ranibizumab intravitreal injection
16176011|NCT01577329|Behavioral|Mindfulness meditation|Group class on mindfulness meditation. One hour weekly class led by nurse expert on meditation that includes mindfulness skills, body awareness skills and emotional awareness skills. Homework is assigned.
16176012|NCT01577316|Biological|Seasonal influenza vaccination|"2011-2012 Seasonal Trivalent Inactivated Influenza Vaccine (include A/California/7/2009 (H1N1)-like, A/Perth/16/2009 (H3N2)-like, and B/Brisbane/60/2008-like antigens) administered to 15ug without adjuvant, via intramuscular in pregnant and nonpregnant women.
~It is recommended that vaccines for use in the 2012-2013 influenza season (northern hemisphere winter) contain the following:
~an A/California/7/2009 (H1N1)pdm09-like virus;
~an A/Victoria/361/2011 (H3N2)-like virus;
~a B/Wisconsin/1/2010-like virus."
16176013|NCT01577303|Behavioral|Cognitive bias modification training program variant 1|Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 1. Participant is exposed to two words -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (< or >) in the previous position of ONE of these words and is then asked to press the corresponding arrow button on a keyboard. A total of 192 word pairs are shown during a session, of one third is the neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe always follows the more positive word.
16176014|NCT01577303|Behavioral|Cognitive bias modification training program variant 2|Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 2. Participant is exposed to a pair of words or a pair of faces -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (< or >) in the previous position of ONE of these words or faces and is then asked to press the corresponding arrow button on a keyboard. A total of 96 word pairs and 96 face pairs are shown during a session. One third is neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe always follows the more positive word or face.
16176015|NCT01577303|Behavioral|CBM training program variant 3|Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 3. Participant is exposed to two words -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (< or >) in the previous position of ONE of these words and is then asked to press the corresponding arrow button on a keyboard. A total of 192 word pairs are shown during a session. One third is neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe always follows the more negative word.
16176016|NCT01577303|Behavioral|CBM training program variant 4|Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 4. Participant is exposed to a pair of words or a pair of faces -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (< or >) in the previous position of ONE of these words or faces and is then asked to press the corresponding arrow button on a keyboard. A total of 96 word pairs and 96 face pairs are shown during a session. One third is neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe always follows the more negative word or face.
16176017|NCT01577303|Behavioral|Control training variant 1|Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 1. Participant is exposed to a pair of words -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (< or >) in the previous position of ONE of these words and is then asked to press the corresponding arrow button on a keyboard. A total of 192 word pairs are shown during a session. One third is neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe follows the more positive word and the more negative word with equal frequency..
16176082|NCT01576692|Other|Cytokines|"Cytokines may be given at the following dosages:
~interleukin-2: 1 million units/m^2 SQ beginning day 6 of each chemotherapy course and continued every other day for 6 doses
~GM-CSF: 250 mcg/m^2/day beginning on day 7 or day 8 of chemotherapy course and continued daily through the nadir until ANC >2,000/mm^3"
16179944|NCT01547000|Drug|placebo|Administered up to 8 weeks.
16176018|NCT01577303|Behavioral|Control training variant 2|Computerized, internet-based control training program, variant 2. Participant is exposed to a pair of words or a pair of faces -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (< or >) in the previous position of ONE of these words or faces and is then asked to press the corresponding arrow button on a keyboard. A total of 96 word pairs and 96 face pairs are shown during a session. One third is neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe follows the more positive stimulus and the more negative stimulus with equal frequency.
16176019|NCT01577290|Behavioral|Internet-administered Mindfulness Training Program|A 10 week, internet-administered mindfulness training program, featuring no therapist-support. 10 minutes of training, twice per day.
16176020|NCT01577290|Behavioral|Discussion group|Access to a discussion group with the possibility of sharing experiences, methods of relief, and the like.
16176021|NCT01577238|Drug|1% SPL7013 Gel|Vaginal gel, daily for 7 days
16176022|NCT01577238|Drug|Placebo|Vaginal gel, daily for 7 days
16176023|NCT01577225|Device|OPSITE POST-OP VISIBLE|Patient will be treated with OPSITE POST-OP VISIBLE dressing up to 14 days post surgery
16176024|NCT01577225|Device|Tape and Gauze|Patient will be treated with tape and gauze up to 14 days post surgery
16176025|NCT01577212|Radiation|Individualized dose escalation|Individualized dose escalation on the basis of the maximally tolerable dose to organs at risk - lung, esophagus, spinal cord, heart, brachial plexus
16176026|NCT01577199|Drug|Low-dose Clomiphene|Pretreatment with a 0.1mg estradiol patch in the luteal phase starting 10 days after the LH surge followed by clomiphene citrate 100mgon days 2-6 of the menstrual cycle with 225 international units of gonadotropins (eg Follistim , Menopur) starting on day 5
16176027|NCT01577199|Drug|High dose gonadotropins|Pretreatment with a 0.1mg estradiol patch in the luteal phase starting 10 days after the LH surge followed high dose gonadotropins (eg. Follistim. Menopur) 600IU starting on day 2 of the cycle
16176028|NCT01577186|Drug|Paliperidone ER|Participants will receive paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day (mg/day) orally once daily up to Week 12 as per Investigator's discretion.
16176029|NCT01577173|Drug|MEHD7945A|1100 mg iv every 2 weeks
16176030|NCT01577173|Drug|cetuximab|400 mg/m2 iv loading dose, followed by 250 mg/m2 weekly
16176031|NCT01577160|Drug|Paliperidone ER|Participants will receive paliperidone ER 6 milligram (mg) orally once daily up to Week 12. Dose adjustment will be done at Week 2, 4 and 8 as per investigator's discretion based upon participant's CGI-I score.
16176032|NCT01577147|Other|Ovulation predictions products|Home diagnostics for ovulation prediction will be provided to study volunteers
16176033|NCT01577134|Behavioral|Social-cognitive resource intervention|Intervention group that receives a behavior change technique intervention to increase volitional strategies and physical activity.
16176034|NCT01577134|Behavioral|Social-cognitive resource intervention|Active control group that receives a behavior change technique intervention to increase volitional strategies and volunteering.
16176035|NCT01577134|Behavioral|no intervention|Passive control group that receives no intervention until the 8.5 months follow-up. Subsequently, they receive the information by mail the active groups received within the intervention.
16176036|NCT01577121|Drug|indomethacin|50 mg / 6 hours during 5 days
16176037|NCT01577121|Drug|placebo|50 mg / 6 hours during 5 days
16176038|NCT01577108|Dietary Supplement|Probiotic|oral taking 2 capsules before sleeping per day for 14 days
16176039|NCT01577108|Dietary Supplement|Placebo|oral taking 2 capsules before sleeping per day for 14 days
16176040|NCT01577095|Other|EA + Rosiglitazone|electroacupuncture and Rosiglitazone combined therapy on patient of type II DM
16176041|NCT01577095|Drug|TZD|Rosiglitazone 8 mg single dose
16176044|NCT01577056|Dietary Supplement|Fish oil capsule|4g Omega capsule for 12 weeks
16176045|NCT01577056|Drug|HMG Coenzyme reductase|All FH subjects are on standard statin treatment during study period
16176046|NCT01577043|Drug|Racecadotril|Racecadotril, 30 mg per sachet, dosage 1.5 mg./kg./day
16176047|NCT01577043|Other|Placebo|cornstarch powder diluted in distilled water, dosage 2.5 ml per dose
16176048|NCT01577030|Dietary Supplement|Non-fat dairy|Add 4 daily servings per day of non-fat dairy (yogurt, milk, cheese) for a period of 4 weeks
16176049|NCT01577030|Dietary Supplement|Add 4 servings fruit|Add 4 daily servings of fruit (fruit cup, apple sauce, orange juice) and remove all dairy for a period for 4 weeks
16176050|NCT01577017|Drug|Letrozole|Women in group L will be assigned with Letrozole on night at day 5 to day 9 of the cycle
16176051|NCT01577004|Dietary Supplement|omega-3 fatty acid|Subjects will be given four 1 g capsules of fish oil providing 1.4 g/d of EPA and 1.0 g/d of DHA as ethyl esters (Ocean Nutrition, Dartmouth, NS), which is similar to the dose used in previous studies with MCI and AD (20, 21).
16176052|NCT01576978|Behavioral|hatha yoga|The women's group of Yoga will participate in ten week sessions of Yoga once a week for an hour. The sessions will be taught by instructor of Hatha Yoga. For the intervention were chosen 37 postures, three breathing exercises. The sessions were divided into three stages: quieting the mind , breathing rate and the heating of the main joints, postures and breathing exercises, meditation and relaxation. At the beginning and end of each session, we evaluated the pain intensity.Pregnant women in the control group Postural orientations will receive a booklet containing guidelines postural figures and explanatory text on some possible changes in the curvatures of the spine during pregnancy suggestions for positioning of the spine for daily activities, lying postures, sitting and standing. After ten weeks the two groups will be scheduled for the final collection of data.
16176053|NCT01576965|Drug|Fleet Enema (sodium biphosphate and sodium phosphate)|Those assigned to the mechanical bowel prep group will be asked to administer a single sodium phosphate enema rectally before going to bed the night before surgery. If stool is not clear in the morning, mechanical bowel prep subjects will administer one additional enema the morning of surgery
16176054|NCT01576952|Drug|ISV-303|Bromfenac in DuraSite
16176055|NCT01576952|Other|DuraSite Vehicle|DuraSite Vehicle
16176202|NCT01575899|Drug|Clarithromycin-Amoxicillin|Clarithromycin, 500 mg b.i.d., amoxicillin, 1000 mg b.i.d. and rabeprazole 20 mg b.i.d. for 7 days.
16176056|NCT01576939|Radiation|Intensity Modulated Radiation Therapy|"We are using thermoluminescent dosimeter (TLD) to measure the mucosal dose adjacent to the dental fillings in a standard, non-filling optimized IMRT (intensity modulated radiotherapy treatment) plan that is normally delivered in the clinic. If the measured mucosal dose exceeds 35 Gy, we will generate a filling optimized IMRT plan to reduce it to < 35 Gy. The new plan will be deemed acceptable and implemented only if it does not (1) compromise the tumor coverage, (2) increase the dose to either the remaining oral cavity or the spared parotid gland(s)."
16176057|NCT01576913|Other|Music listening|Listening to tempo music while cycling in an exercise test
16176058|NCT01576900|Behavioral|SyBeMeP (Systemized Behavioural Modification education Program)|"Standard video material will be developed to minimize variation of outcomes caused by differences in contents at each trial site.
~Video material will be self-study program for PC with running time around 20 minutes. Contents will cover pathophysiology, diagnosis and treatment process, and be easy to understand for everyone with variety of examples. In treatment part, it will describe general principles of behavioural therapy (Adjustment of timing of fluid intake, Reducing alcohol and caffeine, Improving sleep hygiene including moderate exercise, room temperature, noise and lighting. if necessary, compressive stocking, late afternoon nap and leg elevation would be added)
~During trial, patients will watch SYBeMeP at a specially prepared separate room with computer.
~After watching the video, check-list on take-home message will be recorded by patients at the site to confirm patients' awareness after education."
16176059|NCT01576887|Drug|Bardoxolone Methyl 20 mg|Oral, once daily
16176060|NCT01576887|Drug|Placebo|Oral, once daily
16176061|NCT01576874|Drug|Oxytocin|40 IUs of oxytocin administered intranasally one time
16176062|NCT01576874|Drug|placebo|placebo administered intranasally one time
16176063|NCT01576861|Drug|Somatotropin|Subcutaneous Somatotropin (recombinant Human Growth Hormone) 0,012 mg/kg every second day
16176064|NCT01576848|Dietary Supplement|Protein|"Subjects will receive a drink containing 20 gram intrinsically labelled casein.
~Half of the subject are young males (YOUNG)(age between 18 and 35 y) and half of the subjects are elderly males (OLD)(age between 70 and 85 y)."
16176065|NCT01576848|Dietary Supplement|Protein + carbohydrate|"subjects will receive a drink containing 20 gram intrinsically labelled casein plus 60 gram carbohydrates.
~Half of the subject are young males (YOUNG)(age between 18 and 35 y) and half of the subjects are elderly males (OLD)(age between 70 and 85 y)."
16176066|NCT01576822|Other|This protocol will utilize a sauna as the primary method of detoxification.|"This study is a randomized, 2-arm, dose-finding safety and feasibility trial. After screening, informed consent and randomization, participants will complete a medically-monitored sauna-based detoxification program.
~High Dose Participants randomized to this group will undergo a protocol consisting of 2 hours of sauna therapy per day, for a minimum of 5 days per week, completed in 3 weeks or less (21 days). (15 total sessions, 30 hours of sauna).
~Low Dose Participants randomized to this group will undergo a protocol consisting of 1 hour of sauna therapy per day, for a minimum of 3 days per week, completed in 3 weeks or less (21 days). (9 total sessions, 9 hours of sauna)."
16176067|NCT01576809|Drug|IFF flavor 316 282, Paracetamol , Phenylephrine, Guaifenesin|Single dose syrup containing a warming flavor IFF flavor 316 282, in a syrup containing Paracetamol 500 mg + phenylephrine 10mg + Guaifenesin 200 mg per 30 ml syrup
16176068|NCT01576796|Radiation|Radiotherapy|"No additional dose (patients negative F-miso)
~Radiation therapy is conducted under standard conditions of conformal radiotherapy:
~The total dose was 66-70 Gy delivered in daily fractions of 2 Gy, 5 days a-week
~With additional dose (patients positive for F-miso)
~The dose in the PTVmiso increased until the maximum tolerable radiation by the lung."
16176069|NCT01576783|Drug|Docosahexaenoic Acid + Arachidonic Acid (DHA+AA)|200 mg DHA+ 200 mg AA per day for 6 months
16176070|NCT01576783|Dietary Supplement|Placebo|400 mg corn oil per day for 6 months
16176071|NCT01576770|Device|lidocaine/tetracaine transdermal patch (NDC 43469-864-01)|70 mg lidocaine / 70 mg tetracaine
16176072|NCT01576770|Drug|Gebauer's Ethyl Chloride|Spray is to be applied topically to skin (dorsum of the hand for study purposes)until it turns white or for up to 10 seconds.
16176073|NCT01576731|Drug|Tenofovir, Emtricitabine, Lopinavir/r|Combination drug
16176074|NCT01576731|Drug|Tenofovir, Emtricitabine, Raltegravir|Combination drug
16176075|NCT01576718|Drug|Fp MDPI|"Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened.
~During the treatment period, participants were randomized to 50, 100, 200 or 400 mcg of Fp one inhalation twice a day for a total daily dose of 100, 200, 400 or 800 mcg. Study drug was administered in the morning and in the evening."
16176076|NCT01576718|Other|Placebo MDPI|Placebo multidose dry powder inhaler (MDPI) in the morning and evening. Placebo MDPI was provided in devices identical in appearance to Fp MDPI.
16176077|NCT01576718|Drug|Flovent Diskus|Flovent Diskus contains the active ingredient fluticasone propionate (Fp). Flovent Diskus 250 mcg was used twice a day, once in the morning and evening, for a total daily dose of 500 mcg of Fp. This therapy was not blinded as the inhaler device was different than the MDPI used in the other treatment arms.
16176078|NCT01576718|Drug|albuterol/salbutamol|A short-acting β2-adrenergic agonists (SABA), albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI), was provided to be used as needed for the relief of asthma symptoms during both the run-in and treatment periods (to replace the subject's current rescue medication).
16176079|NCT01576705|Drug|thyroid hormone and folinic acid|thyroid hormone 25microg or placebo in tablets folinic acid 5 mg or placebo in capsules
16176080|NCT01576692|Biological|Humanized anti-GD2 antibody|"A maximum of 6 courses of therapy may be given on the following schedule:
~Courses 1, 3, and 5: Humanized anti-GD2 antibody + chemotherapy
~Courses 2, 4, and 6: Humanized anti-GD2 antibody + chemotherapy, with or without natural killer (NK) cells (depending on availability of appropriate NK donor)
~Humanized anti-GD2 antibody (hu14.18 K322A) dosage: 40 mg/m^2)/dose, over 4 hours daily
~NK Cell dosage: minimum of 0.1 * 10^6 cells/kg; maximum of 400 * 10^6 CD45+ cells/kg, given once"
16176081|NCT01576692|Drug|Chemotherapy|"Chemotherapy may include the following at the dosages shown below:
~cyclophosphamide: 400 mg/m^2 IV days 1-5
~topotecan: 1.2 mg/m^2 IV days 1-5
~temozolomide: 150 mg/m^2 PO at least 1 hour before irinotecan
~irinotecan: 50 mg/m^2 IV over 1 hour daily for 5 days
~carboplatin (AUC 8-dosing based on GFR), IV day 1 only
~ifosfamide: 2 g/m2 IV days 1-3
~etoposide: 100 mg/m2 days 1-3"
16176083|NCT01576692|Biological|Natural killer cells|NK cells from haploidentical family donor will be infused on day 7 or 8, depending on course. NK cells may be infused in either the inpatient or outpatient setting by a physician, Physician Assistant, Nurse Practitioner, or qualified RN. Careful monitoring and supportive care during NK cell infusion will be guided in part by the Standard Operating Procedures for Lymphocytes Infusions in the St. Jude Nursing Policy & Procedure Manual.
16176084|NCT01576692|Device|CliniMACS|The mechanism of action of the CliniMACS Cell Selection System is based on magnetic-activated cell sorting (MACS). The CliniMACS device is a powerful tool for the isolation of many cell types from heterogeneous cell mixtures, (e.g. apheresis products). These can then be separated in a magnetic field using an immunomagnetic label specific for the cell type of interest, such as CD3+ human T cells.
16176085|NCT01576679|Drug|Cathflo (Alteplase)|
16176086|NCT01576679|Drug|Saline|
16176087|NCT01576666|Drug|LDE225|
16176088|NCT01576666|Drug|BKM120|
16176089|NCT01576653|Other|Fungitell Assay in BAL|Fungitell Assay will be performed in BAL from patients with clinical suspicion of IFI
16176090|NCT01576640|Drug|NRT|Participants received nicotine replacement therapy in the form of nicotine gum/lozenge and nicotine patch
16176091|NCT01576640|Drug|Bupropion SR 150mg bid|Subjects were given bupropion SR 150 mg bid throughout the course of the study.
16176092|NCT01576640|Other|Relapse Prevention-Oriented Cognitive Behavioral Therapy|Subjects received relapse-prevention oriented cognitive behavioral therapy that was held weekly for 4 weeks, biweekly for 8 weeks, then monthly for 36 weeks.
16176093|NCT01576627|Dietary Supplement|zinc citrate|10 mg of zinc as either zinc citrate
16176094|NCT01576627|Dietary Supplement|Zinc Gluconate|10 mg of zinc as either zinc gluconate
16176095|NCT01576627|Dietary Supplement|Zinc oxide|10 mg of zinc as either zinc oxide
16176096|NCT01576614|Behavioral|Remote physician rounding|Use of Remote physician rounding using Remote Telepresence Robotics
16176097|NCT01576588|Drug|Rituximab|Rituximab (Rtx) antibody infusions will be administered on Day 1, 2, 3 (cycle 1) and Day 1 (cycles 2 to 4).
16176098|NCT01576588|Drug|Glucocorticoid|Glucocorticoid (either Dexamethasone or Methyl-prednisolone) infusions will be administered on Days 1 to 3 (cycles 1-4(6)) and should precede the Rituximab infusion.
16176099|NCT01576575|Drug|Buprenorphine Control|Control (no pretreatment) - intravenous and sublingual buprenorphine. Some subjects will only undergo session 1 (IV)
16176100|NCT01576575|Drug|Buprenorphine + Rifampin|Liver and gut CYP3A induction (rifampin 600 mg daily), intravenous and sublingual buprenorphine
16176101|NCT01576575|Drug|Buprenorphine + Grapefruit juice|Gut only CYP3A inhibition (grapefruit juice the night before), sublingual buprenorphine
16176102|NCT01576575|Drug|Buprenorphine + Ketoconazole|Liver and gut CYP3A inhibition (ketoconazole 400 mg daily), intravenous and sublingual buprenorphine
16176103|NCT01576549|Drug|LY2127399|Administered subcutaneously
16176104|NCT01576523|Biological|C1-esterase inhibitor - single intravenous dose|A single intravenous dose of C1-esterase inhibitor (Berinert) at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor.
16176105|NCT01576523|Biological|C1-esterase inhibitor - subcutaneous low dose|A low dose of C1-esterase inhibitor will be administered subcutaneously twice a week for four weeks.
16176106|NCT01576523|Biological|C1-esterase inhibitor - subcutaneous medium dose|A medium dose of C1-esterase inhibitor will be administered subcutaneously twice a week for four weeks.
16176107|NCT01576523|Biological|C1-esterase inhibitor - subcutaneous high dose|A high dose of C1-esterase inhibitor will administered subcutaneously twice a week for four weeks.
16176108|NCT01576510|Behavioral|Prolonged Exposure (PE)|Prolonged Exposure (PE) therapy consists of ten 90-minute sessions. Elements of PE include imaginal and in vivo exposure to trauma reminders; breathing retraining; cognitive restructuring; and PTSD psychoeducation. The therapist helps the patient cognitively restructure his/her experience of the traumatic event. Each week the narrative is elaborated, becoming more detailed and exhaustive, until the patient habituates to it, extinguishing the anxiety it formerly aroused.
16176109|NCT01576497|Procedure|EUS-FNA|EUS-FNA with suction/10, 15, 20 to-and-fro motion vs. EUS-FNA without suction/10, 15, 20 to-and-fro motion Visual assessment as stoping rule: 20 to-and-fro motion at different site will be performed when EUS-FNA sampling with 10, 15, 20 to-and-fro motion is unsatisfactory.
16176110|NCT01576497|Device|EUS-FNA with suction|For this prospective single-blinded randomized trial, two 10cc syringes was prepared. Two syringe was provided as same performance. However, one syringe is falsely made as suction syringe (fake one). During EUS-FNA, two syringe is randomly assigned and loaded by a nurse. Thus, operator was blinded which syringe is with suction or without suction.
16176111|NCT01576497|Device|EUS-FNA without suction|For this prospective single-blinded randomized trial, two 10cc syringes was prepared. Two syringe was provided as same performance. However, one syringe is falsely made as suction syringe (fake one). During EUS-FNA, two syringe is randomly assigned and loaded by a nurse. Thus, operator was blinded which syringe is with suction or without suction.
16176112|NCT01576484|Drug|Alirocumab|Alirocumab was supplied in a pre-filled syringe and administered subcutaneously (SC) in the abdomen, thigh, or outer upper arm; REGN727(SAR236553) is an anti-PCSK9 (proprotein convertase subtilisin/kexin type 9) antibody
16176113|NCT01576484|Drug|Placebo Matched to Alirocumab|Placebo matched to alirocumab was supplied in a pre-filled syringe and administered subcutaneously (SC) in the abdomen, thigh, or outer upper arm; REGN727(SAR236553) is an anti-PCSK9 (proprotein convertase subtilisin/kexin type 9) antibody
16176114|NCT01576471|Biological|Trichuris suis ova (TSO)|TSO 7500: 7500 embryonated, viable TSO every 2 weeks X 10 weeks (up to 6 total doses)
16176115|NCT01576471|Biological|Placebo|Placebo: dose every 2 weeks X 10 weeks (up to 6 total doses)
16176116|NCT01576458|Drug|ursodeoxycholic acid|450 mg/day for 14 days
16176117|NCT01576458|Drug|Placebo|placebo
16176118|NCT01576445|Procedure|Mid-vastus approach|Mid-vastus approach to avoid patellar eversion and to minimise the muscle split.
16176119|NCT01576445|Procedure|medial parapatellar approach|medial parapatellar approach
16176170|NCT01576159|Other|Swimming Exercise|During this type of exercise intervention, subjects performed a non-weight bearing exercise. This group participated in sessions of 40-min per day, three days per week, for a period of 12 weeks
16180382|NCT01543776|Drug|abiraterone acetate|Given PO
16176120|NCT01576432|Behavioral|Assess pain with the NIPS score|In group 1 (BF+SSC), neonates dressed with a diaper were held in prone, in SSC with the mother; BF was started at least 5 minutes before heel lance and maintained during sampling. In group 2 (sucrose + SSC), neonates were held in prone between the mothers' breast at least 5 minutes before sampling and 2 ml 24% sucrose was given with a sterile syringe in the mouth 2 minutes before heel lance. In group 3 (SSC), neonates were held between the mother's breast as in group 2, but no sucrose was given. In group 4 (Sucrose), 2 ml 24% sucrose was administered through a sterile syringe in the mouth 2 minutes before heel lance to neonates laid on supine on a cot; the procedure was done in the presence of the mother. Mothers were allowed to speak or touch their babies in all the groups.
16176121|NCT01576419|Drug|PG201 tablet|One PG201 tablet and one celecoxib placebo capsule(after breakfast, in 30minutes), One PG201 tablet and one celecoxib placebo capsule(after dinner, in 30minutes)
16176122|NCT01576419|Drug|Celebrex capsule|One celecoxib capsule and one PG201 placebo tablet(after breakfast, in 30minutes), one celecoxib placebo capsule and one PG201 placebo tablet(after dinner, in 30minutes)
16176123|NCT01576406|Drug|crizotinib|crizotinib 250 mg twice a day
16176124|NCT01576406|Drug|crizotinib|crizotinib 250 mg once a day
16176125|NCT01576406|Drug|crizotinib|crizotinib 250 mg twice a day
16176126|NCT01576406|Drug|crizotinib|crizotinib 250 mg once a day
16176127|NCT01576406|Drug|crizotinib|crizotinib 250 mg once a day
16176128|NCT01576393|Behavioral|Home-based Family Therapy|12 home-based family therapy sessions
16176129|NCT01576393|Behavioral|office-based family therapy|12 office-based family therapy sessions
16176130|NCT01576393|Behavioral|WHE|12 Women's Health Education Sessions
16176131|NCT01576380|Drug|TKI258|TKI258 is dosed on a flat scale of 500 mg, to be administered orally on a 5 days on / 2 days off dosing schedule which will be repeated every week.
16176132|NCT01576367|Biological|ACZ885|
16176133|NCT01576354|Drug|Prolonged-release Fampridine|10mg tablet twice a day (every 12 hours), orally
16176134|NCT01576354|Drug|Placebo|tablet twice a day (every 12 hours), orally (matched placebo is provided as oval-shaped, white to off-white, matrix tablets. Each tablet contains the following inactive ingredients: colloidal silicon dioxide, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, and titanium dioxide)
16176135|NCT01576341|Drug|HX575 epoetin alfa (Sandoz)|Eligible patients are scheduled to receive HX575 (INN: Epoetin alfa) as a solution for injection in order to achieve or maintain the correction of renal anemia.
16176136|NCT01576328|Drug|Mesenchymal Precursor Cells (MPCs)|Single intravenous infusion of MPCs Dose 1
16176137|NCT01576328|Drug|Mesenchymal Precursor Cells (MPCs)|Single intravenous infusion of MPCs Dose 2
16176138|NCT01576328|Drug|Mesenchymal Precursor Cells (MPCs)|Single intravenous infusion of MPCs Dose 3
16176139|NCT01576315|Drug|Itraconazole/voriconazole|The two treatments will be administered orally for 6 months One doage of treatment permitted based on plasma levels will be performed after two weeks of treatment.
16176140|NCT01576302|Behavioral|Diaphragmatic breathing|Patients in this arm will be provided training in diaphragmatic breathing, taught its application in habit-reversal paradigm (to use after eating food and if urge to ruminate).
16176141|NCT01576302|Behavioral|Muscle relaxation|Progressive passive muscle relaxation
16176142|NCT01576289|Other|Histological analysis|Systematic histological analysis of biopsy specimens obtained during routine endoscopic examination
16176143|NCT01576276|Radiation|Integrated MR-PET scan|Integrated MR-PET scan using [11C]diprenorphine
16176144|NCT01576276|Drug|Ketorolac|3 administrations of ketorolac over course of study
16176145|NCT01576263|Drug|Autologous blood transfusion with ropivacaine|Local infiltration analgesia with ropivacaine 3 mg/kg, max 200 mg
16176146|NCT01576263|Drug|Autologous blood transfusion with ropivacaine|Local infiltration analgesia with ropivacaine 3 mg/kg, max 200 mg.
16176147|NCT01576250|Other|unilateral lower limb suspension|This is an intervention study, where each subject will undergo 12 days of unilateral lower limb suspension. Randomly, the dominant or the non-dominant leg of the subject will be suspended by attachment of a sling to a non-rigid ankle brace and to a harness on the upper body and unloaded from all weight bearing. The knee will be slightly flexed at an angle of 130°. Hip, knee and ankle will be fully mobile. The sling will be used during all locomotory activity, and the subjects will use crutches for walking.
16176148|NCT01576237|Other|blood donation|blood donation with preparative hemapheresis
16176149|NCT01576224|Device|"Removable splint omni med, Fischer Medical Aps, DK-2800 Lyngby, Denmark"|To be removed during training exercises three to five times a day
16176150|NCT01576211|Genetic|DNA methylation analysis|
16176151|NCT01576211|Genetic|RNA analysis|
16176152|NCT01576211|Genetic|allele-specific oligonucleotide real-time quantitative polymerase chain reaction|
16176153|NCT01576211|Genetic|gene expression analysis|
16176154|NCT01576211|Genetic|nucleic acid sequencing|
16176155|NCT01576211|Genetic|polymorphism analysis|
16176156|NCT01576211|Other|laboratory biomarker analysis|
16176157|NCT01576198|Genetic|DNA analysis|
16176158|NCT01576198|Genetic|nucleic acid amplification|
16176159|NCT01576198|Other|diagnostic laboratory biomarker analysis|
16176160|NCT01576198|Other|medical chart review|
16176161|NCT01576185|Other|laboratory biomarker analysis|Correlative studies
16176162|NCT01576185|Drug|quizartinib|Via gavage
16176163|NCT01576185|Drug|sorafenib tosylate|Via gavage
16176164|NCT01576172|Drug|Abiraterone Acetate|Given PO
16176165|NCT01576172|Other|Laboratory Biomarker Analysis|Correlative studies
16176166|NCT01576172|Drug|Prednisone|Given PO
16176167|NCT01576172|Drug|Veliparib|Given PO
16176168|NCT01576159|Other|Running exercise|During this type of exercise intervention, subjects performed weight-bearing exercise. This group participated in sessions of 40-min per day, three days per week, for a period of 12 weeks
16176169|NCT01576159|Other|Cycling exercise|During this type of exercise intervention, subjects performed a partial weight-bearing exercise. This group participated in sessions of 40-min per day, three days per week, for a period of 12 weeks
16176201|NCT01575899|Drug|Levofloxacin-Amox/clav.|Levofloxacin, 500 mg b.i.d., amoxicillin/clavulanate, 875mg/125mg b.i.d. and rabeprazole, 20 mg b.i.d. for 7 days.
16176171|NCT01576146|Drug|Etelcalcetide|Administered as an intravenous bolus three times a week at the end of each hemodialysis session at dosages up to a maximum of 15 mg.
16176172|NCT01576133|Behavioral|CAPABLE|Occupational therapy visits plus nursing visits plus handyman repair
16176173|NCT01576133|Behavioral|Attention visits|Participants in the attention control arm will receive 10 one hour visits over the course of 16 weeks. These visits will consist of sedentary activities
16176174|NCT01576120|Other|bowel prep regimen first boost 6 oz. and second boost 3 oz.|"Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.
~In this arm the subjects administered a 6 oz. dose of Suprep as first boost and if needed addtional 3 oz. of Suprep (second boost)"
16176175|NCT01576120|Other|bowel prep regimen first boost 3 oz. and second boost 6 oz.|"Subjects will be instructed to perform the bowel preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure.
~In this arm the subjects administered a 3 oz. dose of Suprep as first boost and if needed addtional 6 oz. of Suprep (second boost)"
16176176|NCT01576107|Other|Exercise counseling (behavior change techniques)|4-week exercise intervention for cancer patients of different entities and out-patient regimes.
16176177|NCT01576107|Other|Stress-management training|4-week stress-management-training for cancer patients of different entities and out-patient regimes.
16176178|NCT01576094|Drug|Milrinone|Before surgery, patients received milrinone (MR) (milrinone lactate 1 mg/ml). Intravenous continuous infusion of the study drug through a separate central line started intraoperatively and was increased step-wise at predefined time points: dose 1, starting immediately after central lines were placed and maintained for the duration of the surgical procedure; dose 2, on NICU admission providing the patient was in stable haemodynamic condition; dose 3, starting after 2 hours of stability with dose 2, and maintained up to 48 hours IND infusion started. Accordingly, patients randomised to MR received 0.5 , 0.75 and 1 microg/kg per min
16176179|NCT01576094|Drug|Levosimendan|Before surgery patients received levosimendan (levosimendan 2.5 mg/ml). Intravenous continuous infusion of the study drug through a separate central line started intraoperatively and was increased step-wise at predefined time points: dose 1, starting immediately after central lines were placed and maintained for the duration of the surgical procedure; dose 2, on NICU admission providing the patient was in stable haemodynamic condition; dose 3, starting after 2 hours of stability with dose 2, and maintained up to 48 hours IND infusion started. Accordingly, patients randomised to LEVO received 0.1 , 0.15 and 0.2 microg/kg per min, for doses 1, 2 and 3, respectively.
16176180|NCT01576081|Device|HEPHAISTOS|HEPHAISTOS unloading orthotic
16176181|NCT01576068|Other|Spirometry|Spirometry done in high-risk customers of community-pharmacies to detect airflow limitation
16176182|NCT01576055|Device|TIGRIS Vascular Stent|Implant
16176183|NCT01576055|Device|BARD LifeStent|Implant
16176184|NCT01576042|Drug|amiodarone|The dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.
16176185|NCT01576042|Drug|sotalol|The choice and dosage of antiarrhythmic medications will comply with the ACC/AHA 2006 Guidelines for Management of Patients with Ventricular Arrhythmias and the Prevention of Sudden Cardiac Death.
16176186|NCT01576042|Device|Biosense Webster's NAVI-STAR Thermo-Cool|The only ablation catheter that will be allowed in this study will be the Biosense Webster's NAVI-STAR Thermo-Cool catheter as it is the only catheter that has been approved by the FDA for sustained monomorphic VT due to prior myocardial infarction in adults.
16176187|NCT01576029|Drug|CABAZITAXEL (XRP6258)|Pharmaceutical form: solution Route of administration: intravenous
16176188|NCT01576029|Drug|DOCETAXEL (XRP6976)|Pharmaceutical form: solution Route of administration: intravenous
16176189|NCT01576016|Device|Accent MRI system (lead safety)|Patients implanted with an Accent MRI system
16176190|NCT01576016|Device|Accent MRI system (with MRI scan)|Patients implanted with an Accent MRI system will receive an MRI scan
16176191|NCT01576003|Drug|Glutamine|0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 days (6 months)
16176192|NCT01576003|Dietary Supplement|L-alanine|0.3 g/kg, taken orally/feeding tube every 12 hours/twice a day for 180 day (6 months)
16176193|NCT01575990|Behavioral|Making A Decision About CRC Screening|"Targeted by age and gender with 3 components.
~Educational component
~Values clarification exercise
~Individualized decision making worksheet
~The intervention or control condition is administered before the index visit with the patient's provider."
16176194|NCT01575990|Behavioral|Drivers 65 Plus|This text booklet is provided as an attention control for those in the control arm and like the intervention is administered prior to the index visit with the patient's provider.
16176195|NCT01575951|Radiation|MRI-DCE|"The treatment follows the standard practice including radiation dose and treatment volumes.
~DCE-MRI imaging is to be performed immediately after CT simulation using the same immobilization device.
~Pre-op DCE-MRI is performed and integrated into radiation simulation planning which is considered a standard technique for radiation oncologist to assess tumor volume and peritumoral edma. It will make radiation field more accurate and precise. This MRI is to be performed on the date of simulation immediately after CT simulation.
~MRI image data is then transferred into radiation eclipse system, and integrated into the planning system for target contouring.
~Follow the standard pre-operative radiotherapy technique using 3D conformal radiotherapy (3DCRT) or intensity modulated radiation therapy (IMRT) to deliver a total dose of 50 Gy at 2 Gy per fraction for trunk or extremity STS, or 45 Gy at 1.8 Gy per fraction for retroperitoneal STS, 5 treatments per week."
16176196|NCT01575938|Behavioral|HIV prevention intervention|"The 6-session HIV prevention intervention curriculum, LifeSkills, incorporates interactive activities, in-depth discussions, videos, games, and role-plays to help young transgender women develop, practice, and integrate new skills into real-life situations. Activities address each aspect our theoretical framework (information, motivation, behavior), including experiences that may pre-dispose young transgender women to HIV/STI risk. Participants will also receive HIV and STI testing and counseling prior to the start of the intervention."
16176197|NCT01575938|Behavioral|Diet and Nutrition|The comparison condition is a 6-session group-based and manualized health promotion intervention. Participants will also receive HIV and STI testing and counseling prior to the start of the intervention.
16176198|NCT01575925|Drug|4 mg Oral POM + 40 mg Oral DEX|
16176199|NCT01575925|Drug|2 mg Oral POM + 40 mg Oral DEX|
16176200|NCT01575912|Other|experimental pain tests|
16176203|NCT01575886|Other|Teachable Moment Communication Process|The Teachable Moment Communication Process intervention is designed to teach clinicians: (1) the skills necessary to recognize and foster teachable moments in clinical encounters, (2) strategies to effectively elicit the patients' perspective on health behavior change, and express their alignment with that perspective, and (3) the ability to respond to the patient in a non-confrontational manner while providing brief advice appropriate to the patient's expressed level of readiness to change. The Teachable Moment Communication Process intervention consists of two, 3-hour educational training sessions including didactic presentation, skill demonstration through video examples, skills practices with standardized patients, and feedback from peers and the trainers.
16176204|NCT01575873|Drug|Denosumab|Administered by subcutaneous injection once every 6 months
16176205|NCT01575873|Drug|Placebo for risendronate|Administered orally once a day
16176206|NCT01575873|Drug|Risendronate|Administered orally once a day
16176207|NCT01575873|Drug|Placebo for denosumab|Administered by subcutaneous injection once every 6 months
16176208|NCT01575860|Drug|Lenalidomide|Lenalidomide, 10mg, oral tablets, daily
16176209|NCT01575834|Drug|Romosozumab|Administered by subcutaneous injection once a month (QM)
16176210|NCT01575834|Drug|Placebo|Administered by subcutaneous injection once a month (QM)
16176211|NCT01575834|Drug|Denosumab|Administered by subcutaneous injection once every 6 months (Q6M)
16176212|NCT01575821|Dietary Supplement|Eucalyptus honey|Parents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep.
16176213|NCT01575821|Dietary Supplement|Labiatae honey|Parents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep.
16176214|NCT01575821|Dietary Supplement|Citrus honey|Parents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep.
16176215|NCT01575821|Dietary Supplement|Silan date extract|Parents were instructed to administer 10 grams of theirs child treatment product (single dose) within 30 minutes of the child going to sleep.
16176216|NCT01575808|Device|GP1101|Endovascular stent graft implantation
16176217|NCT01575795|Drug|Ticagrelor|Ticagrelor 360mg loading dose immediately pre prior percutaneous coronary intervention 360mg loading dose
16176218|NCT01575795|Drug|Ticagrelor|Ticagrelor 180mg loading dose 180mg loading dose
16176219|NCT01575782|Drug|Chloroquine|Daily intake of Chloroquine during radiotherapy
16176220|NCT01575769|Drug|RoActemra/Actemra (tocilizumab)|Tocilizumab 8 mg/kg every 4 weeks for 104 weeks
16176221|NCT01575756|Biological|Octafibrin|Octafibrin was supplied as a powder for reconstitution with water for injection.
16176222|NCT01575756|Biological|Haemocomplettan® P or RiaSTAPTM|Commercially available Haemocomplettan® P or RiaSTAPTM (same product with different names in different markets) were supplied as powders for reconstitution with water for injection.
16176223|NCT01575743|Behavioral|aerobic exercising|All participants take part in an aerobic exercise training program with a total weekly energy expenditure of 17.5 kcal/kg/week over the entire 12-week intervention period. The dose of exercise is determined using exercise prescription guidelines established by the American College of Sports Medicine (ACSM, American College of Sports Medicine, 2000). All trainings take place at a local public gym under supervision of previously trained exercise coaches from the Institute of Exercise and Health Sciences of the University Basel. Participants can choose between different training devices for cardiovascular training. Energy expenditure is assessed using the values of burned calories provided by the training devices based on age, weight and training performance. Heart rate is monitored during all training sessions with chest belt heart rate monitors (Polar®) to ensure training below the anaerobic threshold with heart rates between 60 - 75 % of the maximum heart rate.
16176224|NCT01575730|Procedure|Hyperthermic intraoperative Peritoneal Chemoperfusion|Dose: 460 mg/m², duration: 30 minutes, temperature 37°C
16176225|NCT01575730|Procedure|Hyperthermic intraoperative Peritoneal Chemoperfusion|Dose: 460 mg/m², duration: 30 minutes, temperature 41°C
16176226|NCT01575730|Drug|Hyperthermic intraoperative Peritoneal Chemoperfusion|Dose: 200 mg/m², duration: 90 minutes, temperature 37°C
16176227|NCT01575717|Drug|Vitamin D3 4000 IU|Participants with serum 25-hydroxyvitamin D levels of less than or equal to 15ng/ml will take 4000 IU of vitamin D3 daily by mouth for 6 months
16176228|NCT01575717|Drug|Vitamin D3 2000 IU|Participants with serum 25-hydroxyvitamin D levels of greater than 15 ng/ml and less than or equal to 25ng/ml will take 2000 IU of vitamin D3 daily by mouth for 6 months
16176229|NCT01575704|Other|Exercise|Supervised exercise training (aerobic, resistance, flexibility), 5 times per week
16176230|NCT01575704|Other|Mental Training|Memorial/ mental training and relaxation, 5 times per week
16176231|NCT01575678|Drug|Melatonin|blinded capsule 2-4 mg/day, oral use, for 4 weeks
16176232|NCT01575678|Drug|Lactose|blinded capsule 1/day, oral use, for 4 weeks
16176233|NCT01575665|Device|Partial Rebreathing Mask|Inducing normal CO2 for two hours a day for four weeks
16176234|NCT01575652|Other|Group using angiotensin converting enzyme inhibitor|Measurement of peritoneal protein loss level with use of ACEIs
16176235|NCT01575652|Other|Group not using angiotensin converting enzyme inhibitor|Measurement of peritoneal protein loss level without usage of ACEIs
16176236|NCT01575639|Drug|Oral prednisolone|Dose will be different in the two groups. the high dose group will receive 4 mg/kg/day. The usual dose group will receive 2 mg/kg/day
16176237|NCT01575626|Drug|Sevoflurane|"All active comparators of this study have the same intervention as mentioned ahead:
~First IOP measurement will be performed just before anesthesia induction. Standard general anesthesia will be induced using propofol (5 mcg/ml) administered by target controlled infusion (TCI - Schnider model),fentanyl and rocuronium according to standard protocol of general anesthesia. The second IOP measurement will be performed just before tracheal intubation.
~Following tracheal intubation, concentration of propofol will be decreased till 0 and anesthesia with sevoflurane will be started, followed by 3 more IOP measurements for different end-tidal sevoflurane concentrations (Consented patients will be randomly allocated to one of three groups as mentioned).
~Total of 5 IOP measurements. IOP will be measured by the ophthalmologist via both TonoPen XL and Schioz devices."
16176343|NCT01574820|Drug|rosiglitazone (4 mg)/day|rosiglitazone (4 mg)/day for 6 months
16176238|NCT01575613|Drug|Artemether-lumefantrine combination|Focal screening and treatment in all households in malaria hotspots prior to the peak transmission season. Screening of a sentinel age group by rapid diagnostic tests; all parasitaemic individuals and household members of parasitaemic individuals will be treated.
16176239|NCT01575613|Biological|Bacillus thuringiensis|Treatment of all waterbodies within hotspots with Bti or Bs on weekly basis
16176240|NCT01575613|Biological|Long lasting insecticide treated net (LLINs)|Distribution of LLINs in all households in malaria hotspots; instruction about correct use.
16176241|NCT01575613|Biological|Indoor Residual Spraying (IRS)|6-monthly IRS with deltamethrin in all households malaria hotspots.
16176242|NCT01575600|Other|Intraoperative lactated Ringer's solution|After induction, IV access was established and children were randomly allocated to receive one of two interventions: Group 1, 10 mL/kg/h lactated Ringer's solution; Group 2, 30 mL/kg/h lactated Ringer's solution.
16176243|NCT01575587|Drug|Abiraterone: Treatment A|1000 mg abiraterone acetate administered in the fasting state
16176244|NCT01575587|Drug|Abiraterone: Treatment B|Standardized meal administered 1 hour after the 1000 mg abiraterone acetate dose
16176245|NCT01575587|Drug|Abiraterone: Treatment C|Standardized meal administered 2 hours before the 1000 mg abiraterone acetate dose
16176246|NCT01575587|Drug|Abiraterone: Treatment D|Standardized meal administered 2 hours before and 2 hours after the 1000 mg abiraterone acetate dose
16176247|NCT01575574|Drug|GADOXETIC ACID|all patients will have a magnetic resonance with gadobutrol as reference for diagnosis; in participants an additional magnetic resonance will be done with the new contrast agent to verify if the diagnostic can be done.
16176248|NCT01575561|Drug|Lurasidone|Lurasidone 20-80 mg taken orally once daily
16176249|NCT01575548|Drug|Pazopanib Hydrochloride|Given PO
16176250|NCT01575548|Other|Pharmacological Study|Correlative studies
16176251|NCT01575548|Other|Placebo Administration|Given PO
16176252|NCT01575548|Other|Quality-of-Life Assessment|Ancillary studies
16176253|NCT01575548|Other|Questionnaire Administration|Ancillary studies
16176254|NCT01575535|Genetic|gene expression analysis|
16176255|NCT01575535|Other|flow cytometry|
16176256|NCT01575535|Other|fluorescence activated cell sorting|
16176257|NCT01575535|Other|laboratory biomarker analysis|
16176258|NCT01575535|Other|medical chart review|
16176259|NCT01575522|Other|Laboratory Biomarker Analysis|Correlative studies
16176260|NCT01575522|Drug|Tivantinib|Given PO
16176261|NCT01575509|Other|Berry product|Sugar infused dried lingonberry
16176262|NCT01575509|Other|Bread product|Brown bread
16176263|NCT01575509|Other|Bread product|Whole grain bread
16176264|NCT01575509|Other|Glucose control solution|Glucose solution with a corresponding amount of carbohydrates as provided by the bread test products
16176265|NCT01575509|Other|Glucose-fructose control solution|Control solution with a similar carbohydrate content as provided by the dried lingonberry test product
16176266|NCT01575496|Device|BrainSTIM Transcranial Stimulator|Cathodal stimulation of the auditory cortex with an anode (reference electrode) over the prefrontal cortex. Stimulation will be applied for 20 minutes at 2 mA.
16176267|NCT01575496|Device|BrainSTIM Transcranial Stimulator|Sham tDCS sessions will last 20 minutes.
16176268|NCT01575483|Drug|No Intervention (subjects were previously treated with Onglyza®)|No Intervention
16176269|NCT01575470|Biological|autologous bone marrow mononuclear cells|bone marrow harvest (5ml/kg of body weight) performed within 36 hours of injury, followed by single intravenous infusion of bone marrow mononuclear cells.
16176270|NCT01575457|Behavioral|Career Counseling and Motivational Interviewing|The Healthy Futures Program is an interactive, multi-session training program. There will be participants in 3 different intervention tracks (College/vocational school, Job, and Career Planning). Activities for all three tracks will occur simultaneously. The intervention group will receive the interactive, multi-session training program including newsletters and workshops. Comparison group participants will receive newsletters and be invited to participate in college and career planning workshops.
16176271|NCT01575418|Drug|Rectal formulation (RF) of tenofovir 1% gel|The RF is translucent colorless viscous gel formulation containing 1% (w/w) of tenofovir (PMPA) formulated in purified water with EDTA, glycerin, methylparaben, propylparaben, carbopol, sodium carboxy methyl cellulose, and pH adjusted to 7. The RF is close to isoosmolar with an osmolality of 479 mOsmol/kg.
16176272|NCT01575418|Drug|Vaginal formulation (VF) of tenofovir 1% gel|The original VF is a transparent, viscous gel formulation containing 1% (weight/ weight or w/w) of tenofovir (PMPA, 9-[(R)-2-(phosphonomethoxy)propyl]adenine monohydrate), formulated in purified water with edetate disodium, citric acid, glycerin, methylparaben, propylparaben, hydroxyethylcellulose, and pH adjusted to 4-5. This formulation has been used in all clinical trials (vaginal, penile, and rectal) of tenofovir 1% gel to date.
16176273|NCT01575418|Drug|Reduced glycerin vaginal formulation (RGVF) of tenofovir 1% gel|Modified slightly from the original VF formulation, the RGVF has a lower glycerin content than the VF and a significantly reduced osmolality (836 or 846 versus 3111 mOsmol/kg). Lowering glycerin content lowered the viscosity, so the HEC concentration was increased by 10% (a change considered to be insignificant). The amount of parabens was increased by 10% each to improve the antimicrobical effectiveness. The RGVF formulation with 2.75% HEC was used in MTN-007 (CONRAD IND 73,382; currently enrolling), which is the only clinical study of this formulation. The RGVF formulation has since been modified to increase the viscosity.
16176274|NCT01575418|Radiation|Radiolabeling of study drugs and semen|"Study products (i.e. the gel formulations) will be radiolabeled with 111In-DTPA, an FDA-approved radiopharmaceutical commonly used in diagnostic nuclear medicine studies. The delivered dose per gel study product will be approximately 100 microCuries (µCi) to allow sufficient visualization for the imaging period.
~Autologous whole semen collected from the participants at designated visits will be radiolabeled with a delivered dose of approximately 500 microCuries (µCi) of 99mTc-sulfur colloid, also an FDA-approved radiopharmaceutical commonly used in diagnostic nuclear studies. The study team at JHU has extensive experience administering these radiopharmaceuticals rectally. Both of these radiopharmaceuticals will be prepared and delivered by a commercial radiopharmacy and mixed by the study investigators with the respective gel and whole semen vehicles.
~The study product and autologous whole semen will be loaded into calibrated syringes with luer lock adapter for dosing."
16176458|NCT01573910|Drug|Moxifloxacin ophthalmic solution, 0.5%|
16176275|NCT01575405|Drug|Rectal formulation (RF) of tenofovir 1% gel|The RF is a translucent colorless viscous gel formulation containing 1% (w/w) of tenofovir (PMPA) formulated in purified water with EDTA, glycerin, methylparaben, propylparaben, carbopol, sodium carboxy methyl cellulose, and pH adjusted to 7. The RF is close to isoosmolar with an osmolality of 479 mOsmol/kg. Seven doses of this formulation will be used.
16176276|NCT01575405|Drug|Vaginal formulations (original VF and reduced vaginal glycerin formulation RGVF) of tenofovir 1% gel|The original VF is a transparent, viscous gel formulation containing 1% (weight/weight) of tenofovir (PMPA, 9-[(R)-2-(phosphonomethoxy) propyl]adenine monohydrate), formulated in purified water with edetate disodium, citric acid, glycerin, methylparaben, propylparaben, hydroxyethylcellulose, and pH adjusted to 4-5. One dose of this formulation will be used, with 6 doses of the HEC placebo gel preceding it to balance out this study stage. The reduced glycerin formulation (RGVF) is a modification of the original VF - it has lower glycerin content than the VF and a significantly reduced osmolality (836 or 846 versus 3111 mOsmol/kg). Lowering the glycerin content lowered the viscosity, so the HEC concentration was increased by 10% (a change considered to be insignificant). The amount of parabens was increased by 10% each to improve the antimicrobial effectiveness. The RGVF formulation has since been modified to increase the viscosity. Seven doses of RGVF will be used in this study.
16176277|NCT01575405|Drug|Universal HEC Placebo Gel Formulation|The Universal HEC Placebo Gel contains hydroxyethylcellulose as the gelling agent, purified water, sodium chloride, sorbic acid and sodium hydroxide. The gel is isotonic and formulated at a pH of 4.4 to avoid disrupting the normal vaginal pH and has minimal buffering capacity to avoid the inactivation of sexually transmitted pathogens. Hydroxyethylcellulose is used to approximate the viscosity of microbicide gel candidates. Each pre-filled applicator will deliver approximately 4 mL of HEC placebo gel. Six doses of this gel will be used to balance out the VF stage of the study.
16176278|NCT01575366|Behavioral|Tracking training|The paretic finger movement training at different velocities included two 5-week periods of five days per week, 2-hours per day phases. The frequency for the higher-velocity training is 0.8 Hz, whereas the lower frequency training is 4 times slower, at 0.2 Hz. The two periods are each followed by a 3-week baseline period. The subject is seated in front of a laptop computer with the paretic forearm resting on the arm of the chair in a quiet room at home. The position of the forearm is pronated. An electrogoniometer, composed of a potentiometer attached to a custom hand splint, is placed on the paretic index finger with the potentiometer centered at the metacarpophalangeal joint. To keep the training session time equal between the two training phases, the duration of each slow training trial is 5 sec, compared to 20 sec for each fast training trial. Ultimately, the total number of required finger extension/flexion training movements is equal between the two phases.
16176279|NCT01575353|Device|Venturi mask|The patients will receive oxygen delivered through a conventional Venturi mask. The FiO2 (color coded) will be adjusted in order to obtain a SpO2 between 92% and 98% in hypoxemic patients and between 88% and 95% in hypercapnic patients.
16176280|NCT01575353|Device|Nasal high-flow|The patients will receive oxygen delivered through the nasal high-flow system (Optiflow™). The FiO2 will be adjusted in order to obtain a SpO2 between 92% and 98% in hypoxemic patients and between 88% and 95% in hypercapnic patients. Gas flow will be set at 50l/min.
16176281|NCT01575340|Dietary Supplement|fish oil encapsuled|2 g/d (4 capsules of 500 mg)for 9 weeks
16176282|NCT01575327|Device|Automated settings on the oxygen delivery device|FreeO2 automatically adjusts the oxygen flow delivered to patients based on the SpO2 signal and collects the cardiorespiratory parameters
16176283|NCT01575327|Device|Manual settings with FreeO2 system in collection mode|FreeO2 system does not adjust oxygen flow but collects the cardiorespiratory parameters
16176284|NCT01575314|Device|stapling device|Stapling device include GIA 80, TA 45, endo GIA 60, endo GIA 45
16176285|NCT01575301|Drug|Exenatide, Liraglutide|Dosage, frequency and duration not specified by protocol
16176286|NCT01575288|Drug|Placebo|100g maltose 1/day
16176287|NCT01575288|Drug|High-dose trehalose|100g 1/day
16176288|NCT01575275|Drug|aminolevulinic acid|Given PO
16176289|NCT01575275|Procedure|therapeutic conventional surgery|Undergo surgery
16176290|NCT01575262|Behavioral|Non-cash incentives|Participants used their PAL card to self-monitor physical activity levels (intrinsic motivation) and minutes of physical activity were converted to points (1 minute of PA = 1 point; capped at 30 points per day) over the 12-week intervention period. Points were redeemed for rewards (extrinsic motivation) at week 6 and week 12.
16176291|NCT01575262|Behavioral|Self-monitoring physical activity levels|For those in the 'No Incentive' arm, participants used their PAL card to self-monitor their physical activity levels but did not collect points or earn rewards.
16176292|NCT01575236|Device|Guardian Laryngeal Mask|ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric insertion
16176293|NCT01575236|Device|Supreme Laryngeal Mask Airway|ease of insertion, oropharyngeal seal pressure, fiberoptic position, ease of ventilation, occult blood, gastric insertion
16176294|NCT01575223|Device|NeilMed sinus rinse|High volume saline irrigation
16176295|NCT01575223|Device|Salinex|Low volume saline irrigation
16176296|NCT01575210|Device|CPAP mask|A new vent CPAP mask system will be used in this trial.
16176297|NCT01575210|Device|CPAP mask|A new vent CPAP mask system will be used in this trial
16176298|NCT01575197|Biological|Human Rotavirus Vaccine|Rotavirus vaccine will be administered concomitantly with other routine Expanded Programme on Immunization (EPI) vaccinations at 6 & 10 weeks of age, 10 & 14 weeks of age, or 6, 10, & 14 weeks of age, depending on study arm assignment.
16176299|NCT01575184|Other|caudo-ipsilateral traction of shoulder|After the head rotation (0, 40, 80 degrees) to the contralateral side from the ultrasound measuring site, the slight caudo-ipsilateral traction of shoulder will be applied without changing the degree of the head rotation.
16176300|NCT01575184|Other|The ultrasonographic measurements without shoulder traction|After the head rotation (0, 40, 80 degrees) to the contralateral side from the ultrasound measuring site, the no traction of shoulder will be applied.
16176338|NCT01574872|Device|Placebo|The treatment consist of 15 sessions in a chamber that emulates the environmental characteristics of a natural salt cave but with no salt emanation. Each daily session last 30 minutes.
16176339|NCT01574859|Other|levothyroxine|titration of T4 according to biochemical values
16176340|NCT01574833|Device|pulsed electromagnetic field|PEMF treatment
16176341|NCT01574833|Device|sham|sham treatment
16176301|NCT01575171|Behavioral|Nudge|"Behavioral economics recognizes that individuals often are not fully rational in the purely economic sense, but are subject to the influence of various social, environmental and cognitive factors in their decision making. And, one can take advantage of these findings to nudge individuals, in our case physicians, towards more optimal choices. Physicians randomized to the automated clinical decision support nudge will see the new optout prescribing procedure as part of their EHR interface. This will include initially prescribing the guideline-based medication, simvastatin 20mg. Nearly six months after this visit, physicians will receive a reminder via EHR to schedule a follow-up fasting lipid profile as recommended by ATP III guidelines."
16176302|NCT01575158|Drug|Citalopram|
16176303|NCT01575158|Drug|Clomipramine|
16176304|NCT01575158|Drug|placebo|
16176305|NCT01575145|Behavioral|Quitline facilitation intervention|brief quitline facilitation intervention
16176306|NCT01575145|Behavioral|Brief stop-smoking intervention|brief review of tips to help maintain smoking abstinence, using brochure
16176307|NCT01575119|Behavioral|Decision Aid|Decision Aid tool is presented by respiratory therapist, prompting a discussion with the provider (physician or physician assistant)about smoking around time of surgery
16176308|NCT01575119|Behavioral|Control intervention|Standard of care information, including distributing patent education brochure, to provide information regarding perioperative smoking
16176309|NCT01575119|Behavioral|Decision Aid|Decision Aid tool is presented by respiratory therapist, prompting a discussion with the provider (physician or physician assistant)about smoking around time of surgery
16176310|NCT01575119|Behavioral|Control|Standard of care information, including distributing patient education brochure, to provide information regarding perioperative smoking
16176311|NCT01575106|Device|Heat pain applied using TSA or CHEPS|TSA-2001 Thermal Sensory Analyzer (Medoc LTD Advanced Medical Systems) or the Pathway Medoc (CHEPS model, Contact Heat-Evoked Potential Stimulator, Medoc LTD Advanced Medical Systems)
16176312|NCT01575093|Other|The preparation regimen|Regimen includes administration of 4 Senna tablets 2 days before the procedure, 2-liters of PEG on the evening before the procedure, 2-liters of PEG on the morning of the procedure, 10mg Metoclopramide, two boosts (6-oz and 3-oz) of SUPREP oral sulfate solution and a 10mg Bisacodyl suppository
16176313|NCT01575080|Device|Contour TS Blood Glucose Monitoring System|Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm and forearm using the Contour TS Blood Glucose Monitoring System. All BG results are compared to a reference laboratory glucose method.
16176314|NCT01575054|Biological|botulinum toxin Type A|Double-Blind Study Phase (12 weeks): On Day 1, botulinum toxin Type A 300 U will be given by intramuscular injections into specified muscles of the lower limb, and an optional dose of 100 U may be injected into additional lower limb muscles. Open Label Study Phase: Up to 3 treatments with botulinum toxin Type A up to 400 U will be given by intramuscular injections to the lower limb approximately every 12 weeks over a 42 week period.
16176315|NCT01575054|Drug|Normal Saline|Double-Blind Study Phase (12 weeks): On Day 1, normal saline (placebo) will be given by intramuscular injections into specified muscles of the lower limb, and optional injections may be administered into additional lower limb muscles.
16176316|NCT01575041|Dietary Supplement|Sodium|Sodium Chloride (provided by Microz, Geleen, Netherlands): 8 capsules per day which equals a sodium intake of 3 grams.
16176317|NCT01575041|Drug|Potassium|Potassium Chloride (provided by Microz, Geleen, Netherlands): 8 capsules per day which equals a potassium intake of 3 grams.
16176318|NCT01575041|Drug|Placebo|Placebo (cellulose, provided by Microz, Geleen, Netherlands): 8 capsules per day.
16176319|NCT01575028|Drug|Ropivacaine|The TAP block will be delivered with 0.2ml/kg of 0.2% Ropivacaine with 1:200,000 epinephrine bilaterally
16176320|NCT01575028|Drug|Bupivacaine|The local anesthetic at the incision sites will be injected by the surgeon.
16176321|NCT01575015|Device|Continuous renal replacement therapy (CRRT)|Patients allocated with intraoperative CRRT will have a dialysis catheter inserted and receive CRRT during liver transplantation
16176322|NCT01575015|Procedure|Standard intraoperative support|Patients allocated to standard intraoperative support will receive usual care (no CRRT).
16176323|NCT01575002|Device|Transcranial Direct Current Stimulation (tDCS)|Subjects will undergo 2 sessions of 20 minutes of tDCS stimulation (either active or sham)in a randomized order - each session will be separated by at least one week to prevent carry-over effects.
16176324|NCT01574989|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|Subjects will either undergo (1) active low-frequency rTMS (1Hz continuous), (2) active high-frequency rTMS (10Hz, 2 second trains with inter-train interval of 28 seconds) or (3) sham rTMS (using a sham coil). Each session will last 20 minutes and will be conducted at 100% of the motor threshold.
16176325|NCT01574989|Device|Transcranial Direct Current Stimulation (tDCS)|Subjects will either undergo (1) active anodal tDCS, (2) active cathodal tDCS or (3) sham tDCS. Each session will last 20 minutes and will be conducted using 1mA with 35^2 electrodes.
16176326|NCT01574976|Behavioral|probabilistic choice|subjects should choose between low-certain outcome and high-uncertain outcome
16176327|NCT01574937|Drug|Cabozantinib|28 day cycle
16176328|NCT01574937|Drug|Abiraterone|28 day cycle
16176329|NCT01574924|Other|No intervention.|There are no interventions in this observational study.
16176330|NCT01574898|Drug|V0474 - A mg|Single oral administration
16176331|NCT01574898|Drug|V0474 - B mg|Single oral administration
16176332|NCT01574898|Drug|V0474 - C mg|Single oral administration
16176333|NCT01574898|Drug|V0018 - B mg|Single oral administration
16176334|NCT01574898|Drug|Niquitin® Fresh Mint 4 mg|Single oral administration
16176335|NCT01574885|Device|Halotherapy|The treatment consist of 10 session of micronized iodized salt (sodium chloride) inhalation in a chamber that reproduces the environmental characteristics of a natural salt cave. Each daily session last 30 minutes.
16176336|NCT01574885|Device|Placebo|The treatment consist of 10 sessions in a chamber that emulates the environmental characteristics of a natural salt cave but with no salt emanation. Each daily session last 30 minutes.
16176337|NCT01574872|Device|Halotherapy|The treatment consist of 15 session of micronized iodized salt (sodium chloride) skin exposure in a chamber that reproduces the environmental characteristics of a natural salt cave. Each daily session last 30 minutes.
16176342|NCT01574820|Drug|placebo tablet|placebo tablet for 6 months
16176344|NCT01574807|Drug|mepivacaine + lidocaine followed by lidocaine +lidocaine|1.8 mL of 3% mepivacaine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine
16176345|NCT01574807|Drug|lidocaine + lidocaine followed by mepivacaine + lidocaine|1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine followed by 1.8 mL of 3% mepivacaine followed by 1.8 mL of 2% lidocaine with 1:100,000 epinephrine
16176346|NCT01574794|Other|Muscle strengthening exercises|The group will perform 8-week home based muscle strengthening exercises with 8 weekly supervised sessions which will be conducted by a rehabilitation specialist.
16176347|NCT01574794|Other|Muscle stretching exercise|The group will perform 8 week home based exercise intervention with 8 weekly supervised sessions which will be conducted by a rehabilitation specialist
16176348|NCT01574781|Procedure|Blood draw|Blood is drawn at the appropriate time given their cohort inclusion.
16176349|NCT01574781|Procedure|Cheek swab/Saliva Sampling|In lieu of blood draw, male relatives may donate cheek swab or saliva sample. Children born to participating women can donate cheek swab or saliva sample soon after birth.
16176350|NCT01574768|Procedure|Lateral Pharyngoplasty|Tonsilectomy, microdissection of the superior pharyngeal constrictor muscle within the tonsillar fossa and sectioning of this muscle
16176351|NCT01574742|Drug|Minocycline|Minocycline 200 mg/day (2X100 mg) from day 1 to day 3 and Minocycline 400 mg/day (2X200mg) form day 4 until termination visit (day 35)
16176352|NCT01574729|Drug|Surgery combined with rAd-p53 gene therapy|Surgery combined with rAd-p53 gene therapy during surgery plus post-surgery chemotherapy
16176353|NCT01574729|Procedure|Surgery|Surgery plus post-surgery chemotherapy
16176354|NCT01574716|Drug|MORAb-004|IV, Days 1 and 8 of every cycle until disease progression
16176355|NCT01574716|Drug|Gemcitabine|IV, Days 1 and 8 of each cycle until disease progression
16176356|NCT01574716|Drug|Docetaxel|IV, Day 8 of every cycle until disease progression
16176357|NCT01574716|Drug|Gemcitabine|IV, Days 1 and 8 of each cycle until disease progression
16176358|NCT01574716|Drug|Docetaxel|IV, Day 8 of every cycle until disease progression
16176359|NCT01574716|Drug|Placebo|
16176360|NCT01574703|Drug|placebo|All dosing to have taken place per study A3051123
16176361|NCT01574703|Drug|varenicline tartrate|All dosing to have taken place per study A3051123
16176362|NCT01574703|Drug|bupropion hydrochloride|All dosing to have taken place per study A3051123
16176363|NCT01574703|Drug|Nicotine Replacement Therapy Patch|All dosing to have taken place per study A3051123
16176364|NCT01574690|Device|Mespere Venus System|For this non-invasive system, an adhesive patch (connected to the Mespere Venus system) is placed on the neck of the subject, to determine if the CVP values displayed by the device correlates with the CVP values obtained by RHC and physical exam
16176365|NCT01574690|Procedure|Right heart catheterization (RHC)|Invasive procedure to assess CVP. Standard of care.
16176366|NCT01574690|Procedure|Physical examination of jugular vein|Physicians assess CVP using the subject's jugular vein.
16176367|NCT01574664|Device|RFID Tag (Health Beacon)|The radiologist or surgeon will place the Health Beacons RFID Tag under ultrasonic or stereotactic guidance. The surgeon will use the Tagfinder to locate the lesion.
16176368|NCT01574651|Drug|QVA149|QVA149 110/50µg, once daily (q.d.) is administered via a single-dose dry powder inhaler
16176369|NCT01574651|Drug|Placebo to tiotropium|Placebo to tiotropium capsules daily (q.d.) for inhalation, delivered via proprietary inhaler (Handihaler®). Placebo tiotropium inhalation capsules were matched in size and color to tiotropium 18 μg q.d. inhalation capsules
16176370|NCT01574651|Drug|Placebo to formoterol|Placebo to formoterol capsules twice daily (b.i.d) delivered via Aerolizer® device. Placebo formoterol inhalation capsules were equally matched in size, shape and color to formoterol 12 μg b.i.d. inhalation capsules.
16176371|NCT01574651|Drug|Tiotropium|Tiotropium 18µg, once daily is administered via the manufacturer's proprietary inhalation device.
16176372|NCT01574651|Drug|Formoterol|Formoterol 12µg, twice daily is administered via the manufacturer's proprietary inhalation device.
16176373|NCT01574651|Drug|Placebo to QVA149|Placebo to QVA149 is administered via a single-dose dry powder inhaler. Placebo QVA149 inhalation capsules were equally matched in size, shape and color to QVA149 110/50 μg q.d. inhalation capsules
16176374|NCT01574638|Drug|Rifapentine (RPT)|Participants will receive 150-mg RPT tablets orally either once or twice daily, with total tablet number/dosage amount varying according to weight at entry and arm assignment and following dosing tables in the protocol.
16176375|NCT01574612|Drug|acyclovir/hydrocortisone cream|cream applied topically to lesion five times daily for five days
16176376|NCT01574599|Other|Occupational therapy- Repetitive Facilitative Exercise|Occupational therapy program - Repetitive facilitative exercise therapy protocol including 40 min of RFE and 20 minutes of task-specific activity. 3 treatment sessions weekly for a total of 4 weeks.
16176377|NCT01574586|Device|Bifurcation stenting|Bifurcation stenting using 2-link stent Nobori versus 3-link stent Xience
16176378|NCT01574573|Behavioral|Self support, group sessions|Self support,group sessions
16176379|NCT01574560|Behavioral|Brochure|Information regarding secondhand smoke and creating a healthy home environment.
16176380|NCT01574560|Behavioral|Counseling|Receives brochure and counseling sessions focusing on changing smoking behaviors and/or other health behaviors.
16176381|NCT01574534|Device|Drug eluting balloon|PCI using paclitaxel-eluting SeQuent® Please balloon, B. Braun Melsungen AG, Berlin, Germany
16176382|NCT01574534|Device|Drug eluting stent|PCI using paclitaxel-eluting Taxus Element® stent, Boston Scientific Corp, Natick MA
16176383|NCT01574508|Drug|Transient Continuous Subcutaneous Insulin Infusion|Patients will be given Continuous Subcutaneous Insulin Infusion during two weeks confinement in the hospital. The initial dosage will be body weight (kg)*0.5, and will be adjusted according to the 7 points glucose monitoring records in the hospital.
16176384|NCT01574508|Drug|Transient Multiple Daily Insulin Injections|Patients will be given Transient multiple daily insulin injections during two weeks confinement in the hospital. The initial dosage will be body weight (kg)*0.5, and will be adjusted according to the 7 points glucose monitoring records in the hospital
16176385|NCT01574495|Other|Error Augmentation|error augmentation for arm motor recovery in individuals with stroke
16176386|NCT01574482|Other|1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).|1 = Intervention 1 (1 test product/day)
16176387|NCT01574482|Other|2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters|2 = Intervention 2 (1 control product/day)
16176388|NCT01574469|Other|1-Low fat fermented dairy product enriched with plant sterol esters (0,8 g equivalent as free sterols) (test)|1 = Intervention 1 (2 test products / day)
16176389|NCT01574469|Other|2-Low fat fermented dairy product (control)|2 = Intervention 2 (2 control products/day)
16176390|NCT01574430|Procedure|PDT|30% or 50% verteporfin dose PDT was given to patients with CSC
16176391|NCT01574417|Dietary Supplement|control margarine|"Subjects will undergo a postprandial test for 5.5 hours, in which 26.7gram of the control margarine is consumed together with a high-fat milkshake.
~Daily consumption of 20 gram of a control margarine (providing daily 3.0 gram of plant stanols), for a period of 3 weeks."
16176392|NCT01574417|Dietary Supplement|plant stanol-enriched margarine|"Subjects will undergo a postprandial test for 5.5 hours, in which 26.7gram of the plant stanol-enriched margarine is consumed together with a high-fat milkshake.
~Daily consumption of 20 gram of a plant stanol-enriched margarine (providing daily 3.0 gram of plant stanols), for a period of 3 weeks."
16176393|NCT01574404|Procedure|Polar body biopsy with PGS|PB biopsy and analysis by comparing the PB results to the FISH/microarray results
16176394|NCT01574391|Device|Epidrum|Epidrum is used
16176395|NCT01574378|Device|conventional closure|non barbed sutures used to close wounds Conventional three layer wound closure using non-locking sutures polyglactin 910 (Vicryl, Ethicon) and polyglecaprone 25 (Monocryl, Ethicon)
16176396|NCT01574378|Device|V-Loc 90|2-layer wound closure using V-Loc 90 barbed suture
16176397|NCT01574365|Drug|RTA 402|
16176398|NCT01574352|Behavioral|Small intervention|The control group are offered a weekly 1 hour training or activity session during six weeks. Furthermore two sessions where the parents are invited to participate in information about diet and exercise.
16176399|NCT01574352|Behavioral|Intervention camp|The children are participating in a 6 week day camp. The camp contains social activities, physical activity training, usual school classes and health education. All meals (healthy food) are consumed during the camp day.
16176400|NCT01574339|Device|EndoStim LES Stimulation System|"The EndoStim LES Stimulation System comprises three components: an electrical stimulation lead, an implantable pulse generator (IPG) and an external programmer.
~The IPG and stimulation lead are to be implanted within the subject's body using conventional laparoscopy. The device programmer is to be used by the study investigator and/or a company technical representative."
16176401|NCT01574326|Drug|Placebo|Placebo for 0.8 g sachets of powder for oral suspension or 800 mg tablets
16176402|NCT01574326|Drug|Sevelamer carbonate|0.8 g sachets of powder for oral suspension or 800 mg tablets
16176403|NCT01574313|Procedure|stellate ganglion block|stellate ganglion block
16176404|NCT01574313|Drug|0.25mg, fludiazine|0.25mg of erispan@ (fludiazine), p.o. one dose only.
16176405|NCT01574313|Drug|25mg cephadol@ (diphenidol)|25mg cephadol@ (diphenidol) p.o. one dose only.
16176406|NCT01574313|Drug|200mg kentons@ (tocopherol nicotinate).|200mg kentons@ (tocopherol nicotinate) p.o. one dose only.
16176407|NCT01574300|Other|therapeutic interventions|All therapeutic interventions are allowed, and their details recorded and correlated with data from the collected biospecimens. Examples would include single or multiple agent chemotherapy or targeted therapeutics
16176408|NCT01574287|Drug|FACBC|Drug is give intravenously over 2 minutes at time of scan
16176409|NCT01574274|Drug|SC-PEG|11 doses Intravenously over one hour
16176410|NCT01574274|Drug|Oncaspar|16 doses Intravenously over one hour
16176411|NCT01574261|Drug|Placebo|Placebo for four months
16176412|NCT01574261|Drug|Inositol|Inositol 4g/die for four months
16176413|NCT01574248|Drug|icatibant|Subcutaneous at time 0 and 6 hours
16176414|NCT01574248|Other|Placebo|Subcutaneous at time 0 and 6 hours
16176415|NCT01574235|Biological|Nivestim®|
16176416|NCT01574222|Biological|autologous dendritic cell adenovirus CCL21 vaccine|Eligible patients will be assigned to a cohort and will receive intratumoral injections of Ad-CCL21-DC in conjunction with tumor sampling.
16176417|NCT01574196|Other|Autonomic nervous system activity records|The description of autonomic equilibrium is based on the use of non-invasive tools such as Holter-ECG monitor (24 hours) which is suitable for longitudinal follow up of cohorts of patients. This tool allows the analysis of instantaneous or delayed variability of the heart rate, in the Hertzian frequency domain after extraction and mathematical transformation of a temporal sequence of R-R spaces from the ECG signal.
16176418|NCT01574183|Drug|Vilazodone|up to 40 mg capsule daily
16176419|NCT01574183|Drug|Placebo|up to 40 mg capsule daily
16176421|NCT01574157|Drug|Sodium bicarbonate|Participants will receive 0.5 meq of sodium bicarbonate per 1 kilogram of lean body weight daily. The total amount will be divided into twice daily doses.
16176422|NCT01574157|Drug|Placebo|Participants will receive an identical number of placebo tablets had they been assigned to the intervention. Placebo will be divided into twice daily doses and receive this for six months.
16176423|NCT01574144|Device|AVIVO™ PiiX Patch Monitor System|External monitoring for 30 days post-discharge.
16176424|NCT01574131|Drug|Fenofibrate|Pill 54 mg or 160 mg tablets every day for 6 months Dosing-5mg/kg up to 160 mg for 6 months
16176425|NCT01574131|Drug|Sugar Pill|pill every day for 6 months
16176426|NCT01574118|Behavioral|Revisiting the Trauma memories|Patient engages in repeated revisiting of their trauma memory under the guidance of the therapist for about 40 minutes. During each revisiting trial the patient closes their eyes and verbally describes the trauma and the feeling and thoughts experienced during the trauma.
16176427|NCT01574118|Behavioral|Processing the trauma memories|The patient and therapist discuss the patient's experience during the trauma revisiting with the goal of helping the patient gain alternative perspectives of the trauma.
16176428|NCT01574118|Behavioral|Psychoeducation|Through patient handouts and didactic instruction, the patient learns about the common reactions to trauma and the rationale for exposure therapy.
16176429|NCT01574118|Behavioral|Trauma Memory Retrieval Trial|Prior to the start of Imaginal Exposure, the patient is asked to recall a threatening element of their trauma memory for 1 minute. This is followed by a 30-minute rest-period prior to beginning imaginal exposure.
16176430|NCT01574118|Behavioral|Exposure to video clips related to the patient's trauma|Patient is seated in front of a computer monitor and instructed to view a 30-min looped video clip that thematically resembles the patient's trauma.
16176431|NCT01574118|Behavioral|Breathing retraining|Patient is seated comfortably in a chair and instructed to breathe slowly and deeply in a relaxed manner.
16176432|NCT01574118|Behavioral|Exposure Homework|Therapist assists the patient in identifying trauma-related situations/activities that the patient is avoiding and encourages the patient to begin to confront these situations between sessions.
16176433|NCT01574118|Behavioral|Compound extinction|The patient repeatedly confronts the truama-related media clip while simultaneously listening to their own trauma script through headphones.
16176434|NCT01574092|Drug|Combination of two marketed drugs (irinotecan and cisplatin)|Irinotecan and Cisplatin will be administered weekly ambulatory, intravenous (iv), until to reach a total of 16 cycles. Cisplatin is administered first and then Irinotecan. Cisplatin 30 mg/m2/d (iv) in one hour,followed by Irinotecan 65 mg/m2/d iv in one hour. There is a one-week rest period every 4 cycles. The total treatment length including 16 cycles + rest weeks is 19 weeks.
16176435|NCT01574079|Other|Traditional Physical Therapy|Traditional physical therapy includes, but is not limited to, therapeutic exercise, functional mobility training, pre-gait and gait activities, electrotherapeutic modalities, and education.
16176436|NCT01574079|Other|Physical Therapy plus Mirror Therapy|The treatment group will receive traditional physical therapy intervention as described in the control group with the addition of mirror therapy. The participant will attempt to perform the flexion exercises with both lower extremities. The patient will be blinded to the affected lower extremity with a mirror, and will be looking at the image of the unaffected lower extremity superimposed on the affected lower extremity as he or she performs the activities.
16176437|NCT01574066|Procedure|Chest CT-scan|Patients with a suspicion of acquired pneumonia visiting the emergency department will do a chest CT-scan
16176438|NCT01574040|Behavioral|Promotion of stair climbing|"Application of labels on all UMC elevator doors stating:  If you take the stairs, you will burn 11 times more calories."
16176439|NCT01574040|Behavioral|Promotion of a low-salt soup alternative for the 'soup of the day'|"Promotion of a low-salt soup alternative for the 'soup of the day' in the UMC staff restaurant, using a sign stating: The cream soup contains 30% less salt and contributes to a healthy blood pressure."
16176440|NCT01574040|Behavioral|Promotion of a low-fat alternative for the butter croissants|"Promotion of a low-fat alternative for the butter croissants in the UMC staff restaurant, using a sign stating: This croissant contains 30% fewer saturated (unhealthy) fatty acids."
16176441|NCT01574040|Behavioral|Exchange of the basket positions of butter and margarine in the UMC staff restaurant between convenient and harder to reach locations|Exchange of the basket positions of butter and margarine in the UMC staff restaurant. In the usual (baseline) situation butter is positioned in the fridge and, therefore, less visible and harder to reach. Margarine is positioned on several convenient locations throughout the restaurant. During the two weeks intervention period these positions will be interchanged.
16176442|NCT01574027|Drug|Vitamin D3 (cholecalciferol)|One capsule per day for six months
16176443|NCT01574027|Drug|Placebo|One capsule per day for six months
16176444|NCT01574014|Behavioral|CBGT|Cognitive-behavioral group therapy
16176445|NCT01574014|Drug|Hydrocortisone|3 x 20 mg Hydrocortisone (oral, 60 min. before MRI1, 60 min. before exposition in CBGT1 and 60 min. before exposition in CBGT2)
16176446|NCT01574014|Drug|Placebo|Placebo (oral, 60 min. before MRI1, 60 min. before exposition in CBGT1 and 60 min. before exposition in CBGT2)
16176447|NCT01574001|Behavioral|Antismoking intervention with no early follow-up|"an anti-smoking intervention in line with the 5A's method without early follow-up; follow-up assessment will be limited to two visits: 3 and 12 months after stroke"
16176448|NCT01574001|Behavioral|Antismoking intervention with minimal early follow-up|"Anti-smoking intervention in line with the 5A's method (Ask, Advice, Assess, Assist, Arrange follow-up. The intervention will be carried out 5-7 days after stroke, before the planned discharge from the hospital. Seven days after discharge from a stroke unit a brief telephone/personal advice will be given aimed to motivate patients to quit smoking; follow-up assessment will include two visits: 3 and 12 months after stroke"
16176449|NCT01574001|Behavioral|Antismoking intervention with intensive early follow-up|"an anti-smoking intervention in line with the 5A's method will be given, including four follow-up visits within 6 weeks after discharge from the hospital (week 1, week 2, week 4, week 6 after stroke); follow-up assessment will include two visits: 3 and 12 months after stroke"
16176450|NCT01573988|Other|Increasing eating frequency|"The subjects receive the same breakfast with two sequences :
~breakfast in one intake at 8:00
~breakfast in four isocaloric intakes (8:00, 9:00, 10:00, 11:00) The sequence made twice : one for metabolic study and one for the study of eating behavior
~The lunch during metabolic study is a standard meal The lunch during behavioural study is an ad libitum buffet test meal.
~The administration order is determined by randomized allocation. The wash-out period is one to three weeks.
~There are not diet or exercise interventions."
16176451|NCT01573975|Drug|5RA-5RCM|rabeprazole 20mg b.i.d + amoxicillin 1000mg b.i.d x 5 days + rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + metronidazole 500mg b.i.d x last 5 days.
16176452|NCT01573975|Drug|5RA-5RCT|rabeprazole 20mg b.i.d + amoxicillin 1000mg b.i.d x 5 days + rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + tetracycline 1000mg b.i.d x last 5 days.
16176453|NCT01573975|Drug|10RCA|rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + amoxicillin 1000mg b.i.d x 10 days.
16176454|NCT01573949|Drug|Metformin|Metformin will be started at 500 mg PO BID and pending lab values may be titrated to 1000 mg PO BID at 1 month for a duration of 3 months.
16176455|NCT01573936|Other|Physical therapy, occupational therapy, psycotherapy, medical consultations|The mean duration of the RP was 7.47 ± 4.45 months, but it was not standardized because this factor was not one of the parameters of interest for this study
16176456|NCT01573923|Biological|mesenchymal stem cells|Conventional therapy plus UC-MSC intravenous administration (4x107/40ml, once per three months, four times in one year)
16176457|NCT01573923|Biological|Conventional therapy|Conventional therapy without cell therapy
16176460|NCT01573871|Other|Experimental Hydrolyzed infant formula|Experimental hydrolyzed infant formula to be fed ad libitum
16176461|NCT01573858|Other|Acupuncture treatment 1|Two sets of acupuncture points will be alternated every second treatment. The first set consists of CV3, CV 6, and ST 29 bilaterally，SP 6 and SP 9 bilaterally. Needles will also be placed in LI bilaterally and GV 20. CV 3, CV 6, ST 29, SP 6, and SP 9 will be connected to and electrical stimulator and stimulated with low-frequency EA of 2Hz, 0.3 ms.
16176462|NCT01573858|Other|Acupuncture treatment 2|Needles will be inserted to a depth of <5 mm, one in each shoulder and on in each upper arm at non-acupuncture points. Electrodes will be attached to the needles and the stimulator will be turned on at an intensity of zero (no active current) in order to mimic EA in the acupuncture treatment 1. No manual stimulation of the needles will be performed.
16176463|NCT01573858|Other|CC|CC 50 mg every day for 5 days (day 3-7 of cycle), for a total of 4 cycles. Non-response will be defined after 4 weeks of CC placebo administration with 3 consecutive weekly negative P4 and hCG levels. Then during the fifth week a higher dose consisting of one more tablet per day (up to 3 tablets per day at third or fourth cycles, if they remain non-responders) will be given 5 days.
16176464|NCT01573858|Other|CC placebo|CC placebo 50 mg every day for 5 days (day 3-7 of cycle), for a total of 4 cycles. Non-response will be defined after 4 weeks of CC Placebo administration with 3 consecutive weekly negative P4 and hCG levels. Then during the fifth week a higher dose consisting of one more tablet per day (up to 3 tablets per day at third or fourth cycles, if they remain non-responders) will be given 5 days.
16176465|NCT01573845|Behavioral|Healthy Eating + Eco-Friendly Campaign|"Participants receive a 6-month school-based campaign that includes:
~A 22-lesson classroom curriculum
~Homework activities that involve the family
~Monthly parent newsletters
~A food shopping and packing guide for parents
~Food demonstrations
~A poster contest
~School wide announcements"
16176466|NCT01573845|Behavioral|Healthy Eating Campaign|"Participants receive a 6-month school-based campaign that includes:
~A 22-lesson classroom curriculum
~Homework activities that involve the family
~Monthly parent newsletters
~A food shopping and packing guide for parents
~Food demonstrations
~A poster contest
~School wide announcements"
16176467|NCT01573832|Other|integrated client care group|receives integrated client care for wound treatment
16176468|NCT01573819|Drug|GSK356278|Cohort 1: A dose of 2mg per day for 10 days; Cohort 2: A dose of Xmg for 14 days. the dose will be determined from Cohort 1 not to exceed 14 mg; Cohort 3: a single dose of Ymg with a wash out of 7 days followed by 28 days of repeat dosing. The dose (Ymg) will be determined from cohort 1 and 2 not to exceed 14 mg.
16176469|NCT01573819|Drug|Placebo|Cohort 1, a placebo per day for 10 days Cohort 2, a placebo per day for 14 days Cohort 3, a single placebo with a wash out of 7 days followed by 28 days of repeat dosing of a placebo per day.
16176470|NCT01573806|Drug|Exenatide|Exenatide, dosed subcutaneously every 12 hours for 4 doses
16176471|NCT01573806|Drug|Exenatide vehicle|Exenatide vehicle, dosed subcutaneously every 12 hours for 4 doses
16176472|NCT01573793|Behavioral|Parenting Education|Will receive parenting educational materials hypothesized to enhance emotional and cognitive development
16176473|NCT01573793|Behavioral|Control Group - Safety Materials|Will receive safety and dental hygiene materials that have no bearing on emotional and cognitive development
16176474|NCT01573780|Drug|Smac mimetic TL32711|Given IV
16176475|NCT01573780|Drug|gemcitabine hydrochloride|Given IV
16176476|NCT01573780|Other|laboratory biomarker analysis|Correlative studies
16176477|NCT01573780|Other|pharmacological study|Correlative studies
16176478|NCT01573780|Procedure|biopsy|Optional correlative studies
16176479|NCT01573767|Drug|Fluticasone propionate 100mcg|all subjects recieve open-label Flovent twice daily duirng the run in and treatment period
16176480|NCT01573767|Drug|Placebo|Placebo inhalation powder during treatment period
16176481|NCT01573767|Drug|Vilanterol|subjects will recieve 4 weeks via NDPI during treament period
16176482|NCT01573754|Drug|Hydroxychloroquine|100 mg by mouth twice weekly
16176483|NCT01573754|Procedure|Phlebotomy|450 mL every 2 weeks
16176484|NCT01573741|Drug|Ketamine|a single infusion of ketamine hydrochloride (0.5 mg/kg) infused over 40 minutes
16176485|NCT01573728|Behavioral|Low dose exercise|Exercise totaling 50 minutes per week and low intensity
16176486|NCT01573728|Behavioral|Public Health Exercise|At least 150 minutes at moderate intensity
16176487|NCT01573715|Drug|NIMBEX|
16176488|NCT01573715|Drug|NIMBEX|
16176489|NCT01573715|Other|WITHOUT NIMBEX|
16176490|NCT01573702|Procedure|Stereotactic Radiosurgery|21 Gy daily for 5 days
16176491|NCT01573702|Drug|Erlotinib|150mg once daily
16176492|NCT01573689|Behavioral|Group intervention based on mutual aid.|Development of a mutual aid group and his actualization on children between nine and twelve years old who had lost one of their parents.
16176493|NCT01573663|Drug|Ambroxol and Levodropropizine|Ambroxol HCl 30mg & Levodropropizine 60mg, PO, Single dose
16176494|NCT01573663|Drug|Ambroxol|Ambroxol HCl 30mg, PO, single dose
16176495|NCT01573663|Drug|Levodropropizine|Levodropropizine 60mg, PO, single dose
16176496|NCT01573637|Drug|Raloxifene|The dose of raloxifene hydrochloride administered will be 60 mg/day. Both placebo and the raloxifene will be administered over 6 months. Patients will take one single daily dose administered in the morning. Drug will be given orally in capsule form.
16176497|NCT01573637|Drug|Lactosa (placebo arm)|Both placebo and the raloxifene will be administered over 6 months. Patients will take one single daily dose administered in the morning. Drug will be given orally in capsule form.
16176498|NCT01573624|Drug|FF/GSK573719|100/15.6
16176499|NCT01573624|Drug|FF/GSK573719|100/31.25
16176500|NCT01573624|Drug|FF/GSK573719|100/62.5
16176501|NCT01573624|Drug|FF/GSK573719|100/125
16176502|NCT01573624|Drug|FF/GSK573719|100/250
16176503|NCT01573624|Drug|FF|100
16176504|NCT01573624|Drug|FF/VI|100/25
16176505|NCT01573611|Dietary Supplement|Grape Powder|36 g of grape powder to be taken twice/day (total of 72 g/day) for 6 months
16176506|NCT01573611|Dietary Supplement|Placebo Powder|36 g of placebo powder to be taken twice/day (total of 72 g/day) for 6 months
16176507|NCT01573598|Drug|Placebo|Matching placebo given orally, once per day
16176508|NCT01573598|Drug|Vilazodone|Vilazodone, 20 mg per day, oral administration
16176509|NCT01573598|Drug|Vilazodone|Vilazodone, 40 mg once per day, oral administration
16176510|NCT01573585|Behavioral|Usual Care|The Usual Care program will consist of 2 sessions a week for 45 minutes for a 6 week duration.
16176511|NCT01573585|Behavioral|FAST protocol|The Fast muscle activation and Stepping Training (FAST protocol) will be exercises emphasizing speed, small squats and protective steps, that will be progressed. This program will be 2 sessions a week for 45 minutes for 6 weeks in duration.
16176512|NCT01573572|Drug|pegaptanib sodium injection|0.3mg of Macugen in a single-use, prefilled glass syringe given every 6 weeks for 48 weeks
16176513|NCT01573546|Behavioral|Aerobic Exercise|Participants will exercise for 6 months. In the initial 3-month supervised phase, patients will exercise 3 times a week at a level of 50-75% of their initial peak heart rate reserve (HRR) or at their peak heart rate without symptoms, or ST-segment depression > 1 mm, as determined at the time of their initial exercise test. Aerobic exercise consists of 10 minutes of warm-up exercises followed by 30 minutes of continuous walking or (stationary) biking. Each exercise session will conclude with a 10 minute period of cool-down exercises. During weeks 13 to 24 (i.e., home maintenance phase), participants will be asked to perform 3 aerobic sessions per week at home at 60-70% HRR.
16176514|NCT01573546|Behavioral|DASH diet|Participants in the DASH condition only receive instruction in modifying the content of their diet to meet DASH guidelines. Participants will be explicitly asked not to exercise and to focus their attention on what they eat. Participants will have been told (in the initial consent form) that the study is designed to study effects of two interventions (altering diet content and exercise) both of which have been shown to improve health. Participants will also be told that it may be easier or more effective for them if they focus first on learning to alter diet content, and they are free to exercise at the end of the 6-month period. Following an initial 1-day feeding period, participants, along with their study partners, will receive instruction on the DASH diet and feedback on their adherence to the diet in a series of half-hour, weekly small group sessions (3 to 4 participants).
16176515|NCT01573546|Other|Health education control|The Health Education control group will receive weekly 30-min lectures on relevant, health-related topics but will not receive instruction in the DASH diet nor will exercise be promoted. These participants will be asked to maintain their usual dietary and exercise habits for 6 months until they are re-evaluated. These sessions are designed to provide useful information about medical aspects of CVD, but will not provide instruction in the DASH diet or exercise.
16176516|NCT01573533|Biological|Rituximab|Rituximab will be infused intravenously on Day 1 and Day 15 at a dose of 375 mg/m2 up to a maximum of 1000mg per dose in children and at a dose of 1000 mg on Day 1 and Day 15 in adults.
16176517|NCT01573520|Other|Monitoring of drug adherence|In the IC group, biological and drug adherence results are shown and discussed through a nephrologists leaded semi-structured motivation interviews at interval of 2 months.
16176518|NCT01573507|Other|sodium lactate infusion|3-6 hours continuous infusion of sodium lactate (20-40 mcg/kg/min)
16176519|NCT01573494|Other|Sampling of blood|7,5 ml of blood
16176520|NCT01573481|Other|pressure support ventilation|Patients in this group are ventilated during the night with pressure support ventilation mode. The level of the pressure support is the same as the previous day.
16176521|NCT01573481|Other|Pressure controlled ventilation|Patients in this group are ventilated during the night (10 PM to 9 AM) with pressure controlled ventilation mode. The level of inspiratory pressure is set to 20 cm H2O and the respiratory rate is adjusted to avoid any spontaneous breathing (respiratory rate > or equal to 12 breath per min).
16176522|NCT01573468|Drug|Tesetaxel|Tesetaxel 27 mg/m2 orally once on Day 1 of each cycle
16176523|NCT01573468|Drug|Placebo|Placebo orally once on Day 1 of each cycle
16176524|NCT01573468|Drug|Capecitabine|Capecitabine 1750 mg/m2/day orally twice daily (in 2 equally divided doses) on Days 1-14 of each cycle
16176525|NCT01573442|Drug|testosterone|10.4 mg
16176526|NCT01573442|Other|placebo|
16176528|NCT01573416|Other|ASSIST-linked brief intervention for hazardous and harmful substance use.|ASSIST-linked brief intervention will be applied to users achieving moderate risk scores in the ASSIST questionnaire. If after randomization are selected to enter the intervention group, they will receive a ten minute counseling carried immediately after the screening instrument. This intervention group will be re-evaluated after 3 months with the same ASSIST screening instrument.
16176529|NCT01573416|Other|Observation|Subjects who obtain a moderate risk score in the ASSIST screening questionnaire and after randomization are selected for the control group, will receive a brochure with substance-abuse information without any further conversation about the subject with the caregiver. This observation group will be re-evaluated after 3 months with the same ASSIST screening instrument.
16176530|NCT01573403|Drug|DLBS2411|1 caplet of DLBS2411 @250 mg and 1 placebo caplet, once daily
16176531|NCT01573403|Drug|DLBS2411|2 caplets of DLBS2411 @250 mg, once daily
16176532|NCT01573403|Drug|Placebo DLBS2411|2 placebo caplets of DLBS2411, once daily
16176533|NCT01573377|Drug|Metformin|425mg bid for morning and evening after meals, one week after treatment, increase the dosage to 850 mg bid. If the patients have side effects such as nausea, diarrhea and other gastrointestinal symptoms, the dose would be reduced to 425mg bid for 1 week, and try the dosage to 425mg tid again, until the maximum tolerated dose.
16176534|NCT01573377|Drug|Ethinylestradiol and Cyproterone Acetate|from the first day of bleeding of the menstrual cycle, daily oral administration of one pill for 21 days consecutively, then stopped taking the pill for seven days, and on the eighth day to start taking the pill again.
16176535|NCT01573351|Drug|Asunaprevir|
16176536|NCT01573351|Drug|Daclatasvir|
16176537|NCT01573351|Drug|Peg-interferon Alfa-2a|
16176538|NCT01573351|Drug|Ribavirin|
16176539|NCT01573338|Drug|Roniciclib (BAY1000394)|oral administration twice daily in a 3 days on/ 4 days off schedule. Starting dose will be 2.5 mg bid and dose will be escalated or de-escalated depending on dose limiting toxicity.
16176540|NCT01573338|Drug|Etoposide|100 mg/m2 will be administered IV on Days 1, 2, and 3 of each 21 day cycle.
16176776|NCT01571570|Drug|TMC435 150 mg capsule|single oral dose of 150 mg TMC435 150 mg capsule
16176541|NCT01573338|Drug|Cisplatin|75 mg/m2 will be administered IV on Day 1 of each 21 day cycle after the etoposide infusion is complete.
16176542|NCT01573338|Drug|Carboplatin|Carboplatin will be administered IV on Day 1 of each 21 day cycle. The dose of carboplatin will be determined for each cycle using the Calvert's formula, to yield an AUC of 5 (mg/mL) • min.
16176543|NCT01573312|Drug|ASO3 Adjuvant|3.75 mcg of H5N1 hemagglutinin plus AS03, will be administered in 2 doses 28 days apart.
16176544|NCT01573312|Biological|Influenza A/H5N1 Vaccine|3.75 mcg of H5N1 hemagglutinin plus AS03 or 3.75 mcg of H5N1 hemagglutinin alone will be administered in two doses 28 days apart.
16176545|NCT01573299|Other|Mobilization of stroke patients|"In the first group (early vertical positioning)the patient can sit outside of the bed, the day after stroke onset. In the second group (progressively vertical positioning), the patient is progressively verticalised and is allowed to sit outside of the bed on the third day after the stroke onset."
16176546|NCT01573286|Drug|Glucagon-Like Peptide 2|Patients will be treated with 20 ug/kg/day GLP-2, in two doses, given subcutaneously for 3 days (Phase 1). If the treatment is well tolerated, GLP-2 will be continued for a total of 42 days.
16176547|NCT01573286|Drug|Glucagon like peptide-2|"Patients will treated with 5, 10 or 20 ug/kg/day of GLP-2, given twice daily by subcutaneous injection. The initial cohort of patients will be treated at 5 ug/kg (n=6), and if this dose is seen to be safe, and levels appropriate, the next group of 6 will be treated at 10 ug/kg/day. If this dose is seen to be safe, and levels appropriate, the final group of 6 will be treated at 20 ug/kg/day.
~Patients will be given GLP-2 at the assigned dose, subcutaneously for 3 days (Phase 1). If the treatment is well tolerated, GLP-2 will be continued, at the same dose, for a total of 42 days."
16176548|NCT01573273|Drug|Oxytocin|intranasal administration, 40 IUs
16176549|NCT01573273|Drug|Saline|intranasal administration, 40 IUs
16176550|NCT01573260|Other|Argentinean Tango classes|Tango participants will attend an 1-hour Argentinean Tango classes twice a week during 12 weeks, with experienced professional tango instructors.
16176551|NCT01573260|Other|Simple pamphlet about the exercise in PD|Controls will follow their usual schedule of pharmacological treatment; will be provided by simple pamphlet about the exercise in PD, and will otherwise to go about their lives as usual.
16176552|NCT01573247|Drug|AKN-028|"Part 1 of the study is a sequential dose-escalation evaluation of AKN-028. Part 1 started as an accelerated intra-patient dose escalation design in one patient at a time (the N=1 portion), and has switched to standard 3 + 3 design with inter-cohort dose escalation when AUC of 12 μM*hrs has been reached. Starting dose of AKN-028 was 60 mg twice a day.
~During Part 2 of the study AKN-028 will be administered at the dose level selected in Part 1. Patients will be treated for a maximum of 3 cycles (first cycle of 14 days followed by 2 cycles of 21 days), with at least a 7-day treatment-free period between cycles. Patients with significant benefit after 3rd cycle may continue treatment at discretion of the investigator for as long as the patient continues to show significant benefit."
16176553|NCT01573234|Device|MySkin patch|Hydrogel and polyurethane film
16176554|NCT01573234|Device|Gauze and Patch|Traditional Dressing
16176555|NCT01573208|Device|Custom guides|Symbios custom guides for TKA
16176556|NCT01573182|Biological|Zostavax|VZV seropositive donors 50 years and over will receive vaccination with a live attenuated herpes zoster vaccine (Zostavax) by the IM route 4 to 6 weeks prior to stem cell harvesting.
16176557|NCT01573169|Drug|Enoxaparin|enoxaparin 0.4 ml sc per day for 10 days started 72 hours after the stroke
16176558|NCT01573169|Other|Graduated compression stockings and/or intermittent pneumatic compression and/or early mobilization|placebo standard therapy
16176559|NCT01573156|Drug|Light activated WST11|WST11-mediated VTP will consist of the combination of a single IV administration of WST11 at doses of 2 mg/kg, or 4mg/kg using 753 nm laser light at a fixed power (150 mW/cm) and energy (200 J/cm) delivered through percutaneous optical fibres. The fibres are introduced into transparent needles that are positioned in the areas of interest under CT image guidance. After a minimum of 3 patients at each drug dosage (2 & 4 mg/kg) has been treated with a light energy of 200 J/cm, the general and local safety will be assessed. The safety results of the first 3 patients treated in each drug dose/number of fibres combination will be reviewed by the investigators prior to escalation to a higher drug dose/number of fibres combination.
16176560|NCT01573143|Drug|Rosuvastatin|Rosuvastatin (20 mg od) started not earlier than 8 days before surgery and continued until the 5th post-operative day included;
16176561|NCT01573143|Drug|Placebo|Placebo started not earlier than 8 days before surgery and continued until the 5th post-operative day included.
16176562|NCT01573130|Behavioral|Physical exercise program|An individualized physical exercise program, administered per internet. Some therapist-support will also be included.
16176563|NCT01573117|Device|RhinoChill|Nasopharyngeal cooling with the RhinoChill device
16176564|NCT01573117|Drug|Cold crystalloid infusions, 0.9%NaCl or Ringer's solution|Infusion of 2L cold crystalloid solution (4°C) over 30 minutes
16176565|NCT01573104|Other|Proteomic assay|Urine will be taken for proteomic assay at baseline, day 1 and day 2
16176566|NCT01573104|Other|Blood sampling|Point of care testing of blood for NGAL/BNP at baseline, day 1 and day 2
16176567|NCT01573104|Other|Biomarker sampling|Urine will be taken at baseline and day 1, day 2 for evaluation of renal biomarkers at later date
16176568|NCT01573091|Procedure|Cardiac Resynchronization Therapy|Any commercially available Cardiac Resynchronization Therapy devices with or without defibrillation backup (CRT-D/CRT-P) can be used upon discretion of the investigator according to current guidelines
16176569|NCT01573078|Behavioral|Questionnaire|Questionnaire consisting of the following validated surveys: Rome II criteria - Scale of Body Connection (SBC), Private Body Consciousness Sub-Scale (PBCS), Body Vigilance Scale (BVS), Emotional Processing Scale (EPS25)
16176570|NCT01573065|Behavioral|Counseling intervention with rapid HIV testing|Counseling intervention (modeled after Brief Negotiation Interview and Project RESPECT-2) coupled with rapid HIV testing. Telephone booster at 2 weeks.
16176571|NCT01573052|Drug|Chlordiazepoxide|25mg four times daily x 3 days then tapered over 3 days
16176572|NCT01573052|Drug|Gabapentin|300mg four times daily x 3 days then tapered over 3 days
16176573|NCT01573013|Dietary Supplement|iron fortified biscuits|10 mg of iron per day for 8 months, either in the form of NaFeEDTA
16176574|NCT01573013|Dietary Supplement|iron fortified biscuits|10 mg of iron per day for 8 months, in the form of FeSo4
16176575|NCT01573013|Dietary Supplement|iron fortified biscuits|EDTA fortified biscuit on a daily basis for 8 months
16176576|NCT01573013|Dietary Supplement|iron fortified biscuits|control biscuit on a daily basis for 8 months
16176577|NCT01573000|Biological|Iodine-131 Anti-B1 Antibody Versus Anti-B1 Antibody in Chemotherapy-Relapsed/Refractory Low-Grade or Transformed Low-Grade Non-Hodgkin's Lymphoma (NHL)|Subjects will be randomized to receive tositumomab and iodine-131 tositumomab (Arm A) or unlabeled tositumomab (Arm B). Subjects randomized to receive unlabeled tositumomab may crossover and receive radiolabeled Iodine-131 tositumomab following progression of their lymphoma. Response in both arms will be assessed at 7 weeks, 13 weeks, and then at 3-monthly intervals for up to 2 years.
16176578|NCT01572987|Device|Radiofrequency Ablation(RFA) by HALO device.|RFA or Surveillance every 2 months for 1 year.
16176579|NCT01572987|Device|Endoscopic mucosal resection(EMR) by mucosectomy kit.|EMR or surveillance every 2 months.
16176580|NCT01572961|Drug|acetylsalicilic acids (Aspirin)|single oral dose of 1g.
16176581|NCT01572961|Drug|Placebo|
16176582|NCT01572948|Drug|roflumilast|The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
16176583|NCT01572948|Drug|placebo|The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
16176584|NCT01572922|Device|R2*-UTE|Ultra short echo time (UTE) magnetic resonance imaging (MRI). Study participants will undergo an MRI examination of the liver on a 1.5T MRI and a 3T MRI scanner each. Because liver biopsy metal needle fragments could interfere with the MRI measurements, the MRI exams will always precede liver biopsy. Multi-echo GRE sequences will be used to acquire images with increasing TEs. Images of the liver will be obtained in transversal slice orientation through the center of the liver at the level of the origin of the main portal vein. At equivalent slice locations R2*-UTE scans will be performed.
16176585|NCT01572922|Device|R2*-GRE|Gradient-echo (GRE) magnetic resonance imaging (MRI). Study participants will undergo an MRI examination of the liver on a 1.5T MRI and a 3T MRI scanner each. Because liver biopsy metal needle fragments could interfere with the MRI measurements, the MRI exams will always precede liver biopsy. Multi-echo GRE sequences will be used to acquire images with increasing TEs. Images of the liver will be obtained in transversal slice orientation through the center of the liver at the level of the origin of the main portal vein. At equivalent slice locations R2*-UTE scans will be performed.
16176586|NCT01572922|Procedure|Liver biopsy|Indications for liver biopsy include, but are not limited, to the need to quantify liver tissue iron and the need to obtain histopathological information of the liver tissue. Liver biopsies will only be performed if clinically indicated and will be done only once per patient. The technique to be used is coaxial percutaneous (transcapsular) technique; however, a coaxial transjugular technique may be performed in subjects with increased bleeding diathesis, since it is associated with less hemorrhagic risk. Healthy volunteers will not undergo liver biopsy.
16176587|NCT01572909|Drug|Bendavia (MTP-131)|0.05 mg/kg/hr
16176588|NCT01572909|Drug|Placebo|Identically appearing placebo
16176589|NCT01572896|Behavioral|Taking Charge: Managing JIA Online|"In addition to standard medical care, adolescents in the experimental group will receive the Taking Charge: Managing JIA Online Internet self-management program. The intervention is a 12-module interactive multi-component treatment protocol - that consists of JIA-specific education, self-management strategies, and social support - that is available in English and French."
16176590|NCT01572896|Behavioral|Standard Medical Care and JIA Resource Center|"The control group is designed to control for the potential effects on outcomes of time, attention and computer use during the intervention and through the 9-month follow-up period. In addition to standard medical care, adolescents in the attention control group will be provided with access to a self-guided patient education study website, which will have two components: basic patient educational materials about JIA (JIA Resource Centre) and online assessments."
16176591|NCT01572857|Biological|urinary excretion of FLC immunoglobulin|"First phase :
~Collection of four urine samples daily for 2 days:
~Of the 24-hour urine
~at 8 AM
~at 12 AM
~at 4 PM
~On each of these urine samples, the following analysis will be performed:
~Proteinuria
~Albuminuria
~Urinary FLC (Freelite ™)
~Urine creatinine
~Second phase:
~Determination of creatinine in 24 hours by measuring the creatinine of 24 hours 3 days in a row."
16176592|NCT01572844|Device|Fractionated Carbon Dioxide (FCO2) Laser|At each treatment visit, a 2 X 2 cm (+/- 1 cm) area of the target calcinosis lesions will be treated with one pass of the Candela QuadraLase (TM) FCO2 laser. Patients will receive a total of 8-10 treatments over a 6 month period.
16176593|NCT01572844|Drug|Sodium thiosulfate|Following treatment with FCO2 laser, 4 ml of 5% Sodium Thiosulfate solution will be applied to the treatment site only. Subjects will receive a total of 8-10 treatments over a 6 month period.
16176594|NCT01572831|Other|PCT and clinical algorithm for stopping abx|In the experimental arm, antibiotics will be stopped based upon the PCT-guided algorithm. This PCT algorithm also incorporates clinical parameters to ensure utmost safety for the patients. These clinical parameters are; resolution of fever (temperature less than 38.3 and greater than 36.0), shock (on no vasopressors), and leukocytosis (<12,000 and >4,000).
16176595|NCT01572818|Procedure|phlebotomy|7 ml/kg without exceeding 500 mL
16176596|NCT01572818|Behavioral|dietary and lifestyle counseling|dietary and lifestyle counseling
16176597|NCT01572805|Drug|melatonin 3mg|To receive sublingual 3 mg melatonin before spinal of anesthesia .
16176598|NCT01572805|Drug|melatonin 6mg|To receive sublingual 6 mg melatonin before spinal of anesthesia .
16176599|NCT01572805|Drug|placebo|To receive sublingual placebo tablet before spinal of anesthesia .
16176600|NCT01572792|Drug|Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)|Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose, twice per day
16176601|NCT01572792|Drug|Aclidinium bromide/formoterol Fixed-Dose Combination (FDC)|Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose, twice per day
16176602|NCT01572792|Drug|Aclidinium bromide|Inhaled Aclidinium bromide 400 μg, twice per day
16176603|NCT01572792|Drug|Formoterol Fumarate|Inhaled Formoterol Fumarate 12 μg, twice per day
16176604|NCT01572792|Drug|Placebo|Inhaled dose-matched placebo, twice per day
16176777|NCT01571570|Drug|TMC435 150 mg oral suspension (20 mg/mL)|single oral dose of 150 mg TMC435 oral suspension
16176605|NCT01572779|Device|BSM device with bio-feedback|A postural bio-feedback device worn by subjects for 4-10hours a day for 6 days spread across 6 weeks for the sub acute low back pain group and for 8 days spread across 10 weeks for the chronic group. The device records movement and muscle activity data relating to the lower back. Bio-feedback is delivered to the subject as an audible tone, visual cue or vibration and aims to prompt the subject to alter their posture or position in line with recommendations given by the treating practitioner. Four small sensors are adhered to the lower back and send data wirelessly to a data logger carried in the pocket by the subject (the size of a small mobile phone).
16176606|NCT01572779|Device|BSM device with no bio-feedback|The BSM device is worn as a placebo with no bio-feedback given to the subject. The subjects in the control group wear the device for 4-10 hours a day for 6 days spread across 6 weeks for the sub acute low back pain group and for 8 days spread across 10 weeks for the chronic group.
16176607|NCT01572766|Other|FRAX Assessment Tool|FRAX Assessment Tool is designed to assess risk for fracture based on country of origin, race, and other factors.
16176608|NCT01572753|Drug|semaglutide|Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 50 ml of water. During the post-dose fasting period of 120 mins, no food or liquid is allowed.
16176609|NCT01572753|Drug|semaglutide|Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 50 ml of water. During the post-dose fasting period of 60 mins, no food or liquid is allowed.
16176610|NCT01572753|Drug|semaglutide|Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 50 ml of water. During the post-dose fasting period of 30 mins, no food or liquid is allowed.
16176611|NCT01572753|Drug|semaglutide|Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 50 ml of water. During the post-dose fasting period of 15 mins, no food or liquid is allowed.
16176612|NCT01572753|Drug|semaglutide|Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 120 ml of water. During the post-dose fasting period of 120 mins, no food or liquid is allowed.
16176613|NCT01572753|Drug|semaglutide|Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 120 ml of water. During the post-dose fasting period of 60 mins, no food or liquid is allowed.
16176614|NCT01572753|Drug|semaglutide|Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 120 ml of water. During the post-dose fasting period of 30 mins, no food or liquid is allowed.
16176615|NCT01572753|Drug|semaglutide|Subjects will be dosed in the morning, for 10 days, after an overnight fast (liquid will not be allowed from 2 hours before dosing). Dose to be taken with 120 ml of water. During the post-dose fasting period of 15 mins, no food or liquid is allowed.
16176616|NCT01572740|Drug|liraglutide|Liraglutide administered subcutaneously (s.c., under the skin) for 36 weeks combined with insulin therapy.
16176617|NCT01572740|Drug|placebo|Liraglutide placebo administered subcutaneously (s.c., under the skin) for 36 weeks combined with insulin therapy.
16176618|NCT01572740|Drug|insulin|All subjects will continue their pre-trial insulin therapy (basal, premixed or basal-bolus regimen) during the trial. Insulin dose is fixed for the first 16 weeks and for the subsequent 20 weeks, insulin dose is individually adjusted.
16176619|NCT01572727|Drug|Paclitaxel|intravenous paclitaxel 80 mg/m2 per week given until progression
16176620|NCT01572727|Drug|BKM120 matching placebo|"Buparlisib maching plaxcebo were supplied as 100 mg and 50 mg hard gelatin capsules.
~Buparlisib placebo was dosed on a flat scale of mg/day and was not adjusted to body weight or body surface area."
16176621|NCT01572727|Drug|BKM120|Buparlisib (BKM120) were supplied as 100 mg and 50 mg hard gelatin capsules. Buparlisib was dosed on a flat scale of mg/day and was not adjusted to body weight or body surface area.
16176622|NCT01572714|Behavioral|Social Support Program|The social support program will consist of 6 weekly, 1.25-hours, teleconference calls with 4 biweekly, 15 minute, follow-up one-to-one phone calls. Topics will include information on MS, disease modifying medications, preventive screening, community organizations, nutrition, cognitive problems, and hiring an aide.
16176623|NCT01572714|Behavioral|Physical Activity Program|The physical activity education program will consist of 3 weekly, 1.25-hours, teleconference calls with 4 biweekly, 15 minute, follow-up one-to-one phone calls. Subjects in this program will learn MS-specific benefits of physical activity, how to use a pedometer to self-monitor their progress for increasing physical activity levels, and learn strategies for maintaining their progress in the program.
16176624|NCT01572714|Behavioral|Physical Activity Plus Fatigue Management Education Program|The physical activity plus fatigue management education program will consist of 6 weekly, 1.25-hours, teleconference calls with 4 biweekly, 15 minute, follow-up one-to-one phone calls. Subjects in this program will learn MS-specific benefits of physical activity, how to use a pedometer to self-monitor their progress for increasing physical activity levels, and learn strategies for maintaining their progress in the program. In addition, subjects in this course will learn strategies to reduce fatigue, such as taking rest breaks and re-arranging workspace.
16176625|NCT01572701|Drug|99mTc-MIP-1404|20 (±3) mCi of study drug will be administered by IV injection as a slow bolus and flushed with approximately 10 mL of saline
16176626|NCT01572688|Drug|Melphalan|powder for injection, 200mg/m2, uses after reconstituted within 24 hours
16176627|NCT01572675|Drug|etorocoxib|Administered as 30 mg or 60 mg oral film-coated tablets
16176628|NCT01572675|Drug|celecoxib|Administered as 100 mg or 200 mg oral hard capsules
16176629|NCT01572662|Drug|Fludarabine monophosphate|40 mg/m2 by vein on Days -6 through -3.
16176630|NCT01572662|Drug|Busulfan|First two doses of Busulfan, 80 mg/m2 administered as an outpatient or as an inpatient to facilitate for this pharmacokinetically directed therapy. Busulfan is administered at the dose calculated to achieve a total (including first two doses delivered on day -13 and -12) systemic exposure of 20,000 ± 12% µMol-min based on the pharmacokinetic studies.
16176631|NCT01572662|Procedure|Stem Cell Infusion|Fresh or cryopreserved bone marrow or peripheral blood progenitor cells infused on Day 0.
16178205|NCT01560689|Drug|Budesonide/formoterol|800 µg/j twice a day, every day
16176632|NCT01572662|Drug|Tacrolimus|Starting dose of 0.015 mg/kg (ideal body weight) as 24 hour continuous infusion daily adjusted to achieve therapeutic level of 5-15 ng/ml. Tacrolimus changed to oral dosing when tolerated and can be tapered off after day +90 if no graft versus host disease (GVHD) present.
16176633|NCT01572662|Drug|Methotrexate|5 mg/m2 by vein on Days 1, 3, 6 and 11 post transplant.
16176634|NCT01572662|Drug|G-CSF|5 mcg/kg/day subcutaneously beginning on Day +7, and continuing until absolute neutrophil count (ANC) is > 500 * 10/L for 3 consecutive days.
16176635|NCT01572649|Drug|Lixisenatide (AVE0010)|"Pharmaceutical form:Solution for injection
~Route of administration: subcutaneous"
16176636|NCT01572649|Drug|Placebo|"Pharmaceutical form:Solution for injection
~Route of administration: subcutaneous"
16176637|NCT01572636|Drug|Laronidase|Administered 0.58 mg/kg/dose intravenously (IV) once a week beginning 12 weeks before planned hematopoietic stem cell transplant (HSCT) and resume same dosing regimen for 8 weeks after HSCT.
16176638|NCT01572623|Drug|Clopidogrel|Loading dose of Clopidogrel 600 mg versus 300 mg before carotid artery stenting
16176639|NCT01572623|Drug|Atorvastatin|Reloading dose of Atorvastatin (80 mg at 12 hours and 40 mg at 6-8 hours before carotid artery stenting) versus no reload.
16176640|NCT01572610|Drug|RTA 402|once a day, oral administration
16176641|NCT01572597|Drug|10RAC+acetylcystein|10-days rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + amoxicillin 1000mg b.i.d + N-acetyl-cystein 600mg b.i.d
16176642|NCT01572597|Drug|10RAC+metronidazole|10-days rabeprazole 20mg b.i.d + clarithromycin 500mg b.i.d + amoxicillin 1000mg b.i.d + metronidazole 500mg b.i.d
16176643|NCT01572558|Procedure|Appendectomy|Standard surgical treatment, normally laparoscopic appendectomy
16176644|NCT01572558|Drug|Conservative, non-surgical treatment|Non-surgical treatment, intravenous and oral antibiotics. Meropenem and Metronidazol will be used as intravenous antibiotics, Ciprofloxacin and Metronidazol will be used as oral antibiotics.
16176645|NCT01572545|Drug|Denosumab|Denosumab (injection), 60 mg, administered as a single subcutaneous injection once
16176646|NCT01572545|Drug|Zoledronic acid|Zoledronic acid (vial), 5 mg, administered once as a single 15- to 30-minute intravenous infusion
16176647|NCT01572532|Other|Screening treatment and referral|"Women who are symptomatic at any study visit will be immediately referred to the sub-district hospital for full evaluation and treatment and will be visited on the following day to follow clinical status and ensure referral compliance. Referral will be reinforced by arranging transportation to the sub-district hospital and payment of hospital fees if the family is unable to afford out-of-pocket expenses. CHWs will conduct a home visit to women with positive test results within 24 hours of receiving the results to initiate treatment. All asymptomatic women will be treated for positive test results. For symptomatic women, the CHW will confirm the woman's clinical and treatment status, and provide treatment to those women who have not already received the appropriate treatment at the sub-district hospital for their infection.
~Antibiotic Treatment Regimens AVF: Oral clindamycin 300 mg per oral (po) twice daily (bid) for 5 days.UTI: Macrobid/Nitrofurantoin 100 mg po bid x 7 days."
16176648|NCT01572519|Drug|Phase 1, Cohort 1|Type=exact number, unit=mg, number=150, form=capsule, route=oral use. Capsule is taken once daily.
16176649|NCT01572519|Drug|Phase 1, Cohort 2|Type=exact number, unit=mg, number=300, form=capsule, route=oral use. Capsule is taken once daily.
16176650|NCT01572519|Drug|Phase 1, Cohort 3|Type=exact number, unit=mg, number=450, form=capsule, route=oral use. Capsule is taken once daily.
16176651|NCT01572519|Drug|Phase 1, Cohort 4|Type=exact number, unit=mg, number=600, form=capsule, route=oral use. Capsule is taken once daily.
16176652|NCT01572519|Drug|Phase 2|JNJ-40346527 at the recommended dose determined in Phase 1
16176654|NCT01572493|Biological|rh IL-15 (10 DAYS)|Continuous infusion of rhIL-15 IV for first 10 days of each cycle
16176655|NCT01572493|Biological|rh IL-15 (5 DAYS)|Continuous infusion of rhIL-15 for first 5 days of each cycle
16176659|NCT01572467|Genetic|RNA analysis|
16176660|NCT01572467|Genetic|gene expression analysis|
16176661|NCT01572467|Genetic|mutation analysis|
16176662|NCT01572467|Genetic|reverse transcriptase-polymerase chain reaction|
16176663|NCT01572467|Other|laboratory biomarker analysis|
16176664|NCT01572467|Other|medical chart review|
16176665|NCT01572454|Drug|Dexmedetomidine infusion|Dexmedetomidine infusion 0.2 mcg/kg/hr during anesthetic induction 0.3 - 0.7 mcg/kg/hr during the surgery
16176666|NCT01572454|Drug|Remifentanil infusion|Remifentanil infusion 0.05 - 0.3 mcg/kg/min during the anesthetic induction and surgery
16176667|NCT01572428|Procedure|Inspection with Narrow-Band Imaging(NBI)|Narrow-Band Imaging(NBI)of the colon rather than the standard white light in the inspection of the colon during colonoscopy.
16176668|NCT01572428|Procedure|Standard White Light|Use of Standard White Light on the colon rather than Narrow-Band Imaging(NBI)in the inspection of the colon during a colonoscopy.
16176669|NCT01572402|Other|Bagueutte Cheese Gourmet (Crocodille)|180g, energy 452.8 Kcal/1895.7 kJ, composition: carbohydrates 49,2 g (44,55%), proteins 18,5 g (16,74%), lipids 18,8 g (38,7%), of which saturated 6,8 g, monounsaturated 6,0 g, polyunsaturated 5,0 g.
16176670|NCT01572402|Other|Cous-cous sandwich|235 g, energy 455,88 Kcal /1907,4 kJ, composition: carbohydrates 59,54 g (52,24%), proteins 12,47 g (10,57% %), lipids 18,85 g (37,31%), of which saturated 6,2 g, monounsaturated 11,49 g, polyunsaturated 28,26 g
16176671|NCT01572402|Other|McCountry sandwich (McDonald's)|150g, 455 kcal/1903,72 kJ, composition: carbohydrates 31 g (27,25%), proteins 24 g (21,1%), lipids 26 g (51,43%), of which saturated 10 g (38,45%)
16176672|NCT01572389|Behavioral|Healthy Outcomes through Patient Empowerment (HOPE)|HOPE participants will receive 6 behavioral coaching telephone sessions and 3 booster sessions over a six month period followed by usual primary care during the subsequent 6 months maintenance period.
16178206|NCT01560689|Drug|Placebo|Twice a day, every day
16176673|NCT01572389|Behavioral|Enhanced Usual Care|All participants receive usual VA primary care plus a dedicated screening for diabetes control and clinically significant depressive symptoms. Patients and primary care providers are notified of these results and given recommendations for usual care.
16176674|NCT01572376|Procedure|Infusion of autologous bone marrow stem cells after wound debridement.|Cleaning of the wound with heparinized saline, cell infusion and closing with suture.
16176675|NCT01572363|Drug|Sildenafil|50 mg once
16176676|NCT01572350|Other|Grid laser|Grid laser therapy acts as the standard to refer to as it is the treatment which is currently accepted by EMDDNT.
16176677|NCT01572350|Drug|Triamcinolone Acetonide|Triamcinolone 4 mg followed by modified grid laser therapy after 3-4 weeks
16176678|NCT01572350|Drug|Bevacizumab|Bevacizumab (1.25 mg initially, weeks 6 and 12) followed by modified grid laser therapy after3-4 weeks
16176679|NCT01572337|Procedure|Non-invasive ventilation|Early non-invasive ventilation will be given to patients at an early stage of acute respiratory failure
16176680|NCT01572337|Other|Standard care|
16176681|NCT01572324|Drug|Oxaliplatin, Fluorouracil, Leucovorin, Capecitabine|HAI of Oxaliplatin and Fluorouracil: Oxaliplatin 130mg/m2 in split daily doses for 3 days, Fluorouracil 3000 mg/m2 in split daily doses for 3 days. Intraarterial Oxaliplatin plus intravenous Leucovorin 200 mg/m2 simultaneously over 2 hours followed by intraarterial Fluorouracil over 22 hours on Days 1-3 of each cycle, repeat every 21 days. After 4-6 cycles of HAI, maintenance treatment continue, Maintenance of Oral capecitabine 1,000 mg/m2 twice a day from days 1-14, Cycles were repeated every 21 days.
16176682|NCT01572311|Behavioral|Exercise Intervention|Goal of 150 minutes of structured exercise/week; minimum of 120 minutes from CCAA classes/week. The 75-minute class includes: 5-minute warm-up; 25 minutes of AE (70-85% maximum heart rate); 5-minute cool-down; 20 minutes of strength training; 5 minutes of core strengthening; 5 minutes of balance training; and 10 minutes of stretching. The 60-minute program is identical except: 15 minutes total for all strength training (including core) and 5 minutes of stretching. Following CCAA classes, participants continue with dual-task gait training where they are required to walk on a special mat with a designated walking pattern (beginner level Square Stepping Exercise) while answering cognitively challenging questions.
16176683|NCT01572311|Behavioral|Exercise Control|Goal of 150 minutes of structured exercise/week; minimum of 120 minutes from CCAA classes/week. The 75-minute class includes: 5-minute warm-up; 25 minutes of AE (70-85% maximum heart rate); 5-minute cool-down; 20 minutes of strength training; 5 minutes of core strengthening; 5 minutes of balance training; and 10 minutes of stretching. The 60-minute program is identical except: 15 minutes total for all strength training (including core) and 5 minutes of stretching. Following CCAA classes, participants continue with gait training where they are required to walk on a special mat with a designated walking pattern (beginner level Square Stepping Exercise). This will not include any dual-task challenges.
16176684|NCT01572298|Device|allograft alone|use of MinerOss allograft plus Alloderm GBR membrane and tenting screws
16176685|NCT01572298|Device|allograft with autograft|use of a combined autogenous graft and MinerOss allograft plus Alloderm GBR membrane and tenting screws
16176686|NCT01572285|Procedure|transforaminal dexamethasone injection|Subjects received transforaminal infiltration of lidocaine 1% 0.5mL and 1.5mL of Dexamethasone 10mg/ml
16176687|NCT01572285|Procedure|Sham|Sham procedure using a non-penetrating needle
16176688|NCT01572259|Drug|Growth Hormone|
16176689|NCT01572259|Other|interruption of the traitment with growth hormone|
16176690|NCT01572246|Other|Optimal placement of return pad|The ESU return pad will be placed in an optimal position in order to direct ME current away from the ICD pulse generators.
16176691|NCT01572233|Behavioral|Personalized Physical Activity and Psycho-Education (PPAPE) Program|"Effects of Personalized Physical Activity and Psycho-Education Program on Patients with HCV infection
~The third and fourth year, will be examine on the 12, 24, 36, and 48 weeks during the interferon treatment."
16176692|NCT01572220|Other|UCA stress echocardiography or myocardial SPECT|Comparative Effectiveness of cardiac stress imaging modalities
16176693|NCT01572207|Behavioral|Immediate exercise|Subjects in the immediate exercise group will be prescribed a home exercise program during the first meeting and will begin the 12 week training period immediately following the first meeting.
16176694|NCT01572207|Behavioral|Delayed exercise|Subjects in the delayed exercise group will begin the home exercise program 12 weeks following the initial meeting.
16176695|NCT01572194|Biological|Urinary levels of PIIINP as a marker of changes in renal function|The act under consideration is the determination of PIIINP urinary. The aim of the study is to show the predictive value of PIIINP urinary in assessing renal function in patients with mucoviscidosis receiving a lung transplant.
16176696|NCT01572181|Drug|Fludarabine IV- Busulfan IV (Busilvex®) - Anti-thymocyte globulines (Thymoglobuline®)|"IV fludarabine (30 mg/m²/day for 5 days)
~IV Busulfan (Busilvex 3.2 mg/kg/day for 4 days) (the Busulfan dose is to be adapted to the weight of the child according to the drug label)
~Anti-thymocyte globulines (Thymogolubuline, 2.5 mg/kg/day for 2 days)."
16176697|NCT01572168|Other|Acupuncture|Eight session of weekly acupuncture
16176698|NCT01572155|Procedure|Vagus stimulation 1|2 times 2 minutes (beginning and end of surgery) stimulation at 5 Hz, 500 micro s, 2.5 mA
16176699|NCT01572155|Procedure|Vagus stimulation 2|2 times 2 minutes (beginning and end of surgery) stimulation at 20 Hz, 500 micro s, 2.5 mA
16176700|NCT01572129|Drug|Clopidogrel|600 mg clopidogrel loading dose 6-8 h before diagnostic coronary angiogram
16176701|NCT01572129|Drug|Placebo|Placebo in addition to the chronic daily dose of 75 mg
16176702|NCT01572116|Drug|Lidocaine with Epinephrine+ Normal saline|PDL injection of 0/4 ml of lidocaine %2 with epinephrine,and Normal saline
16176703|NCT01572116|Drug|Lidocaine with Epinephrine + sufentanil|PDL injection of 0/4 ml lidocaine with epinephrine and0/4 ml sufentanil ( 0/04 μg)
16176704|NCT01572103|Dietary Supplement|Coffee|Administration of 4 cups of coffee per day for 1 month
16176705|NCT01572103|Dietary Supplement|coffee abstinence|total abstinence for both coffee and caffeine containing beverages
16176706|NCT01572090|Behavioral|Lifestyle Changes|"Hypocaloric diet providing a 1000 kcal/d deficit from total energy expenditure assessed by indirect calorimetry and physical activity determination.
~Dietetic and physical activity counselling with a dietitian."
16176778|NCT01571570|Drug|TMC435 150 mg oral solution (10 mg/mL)|single oral dose of 150 mg TMC435 oral solution
16178207|NCT01560676|Behavioral|HEALTH[e]TEEN|8 lessons over 6-8 weeks
16176707|NCT01572090|Other|Adjustment of oral antidiabetics/insulin therapy|Continuation-discontinuation of medical antidiabetic therapy if needed in accordance with good clinical practice. In addition to the surgery, patients will have regular follow-up with an endocrinologist for appropriate counselling on lifestyle changes (diet, physical activity and vitamin/mineral supplementation counselling) following bariatric surgery as well for adjustment of antidiabetic medication. Adjustment of oral antidiabetics/insulin therapy consisting in continuation, adjustment or discontinuation of medical antidiabetic therapy if needed in accordance with good clinical practice.
16176708|NCT01572090|Procedure|Laparoscopic sleeve gastrectomy|The Laparoscopic sleeve gastrectomy SG-NG involves the removal of the mayor curvature of the stomach via a laparoscopic approach. In addition to the surgery, patients will have regular follow-up with a dietitian and endocrinologist for appropriate counselling on lifestyle changes (diet, physical activity and vitamin/mineral supplementation counselling) following bariatric surgery.
16176709|NCT01572090|Procedure|Laparoscopic Roux-en-Y gastric bypass|Laparoscopic Roux-en-Y gastric bypass. In addition to the surgery, patients will have regular follow-up with a dietitian and endocrinologist for appropriate counselling on lifestyle changes (diet, physical activity and vitamin/mineral supplementation counselling) following bariatric surgery.
16176710|NCT01572077|Radiation|FTHA, FDG PET imaging.|Subjects will undergo PET scans on 2 different days using 2 separate tracers, FTHA(fluoro-6-this-hepadecanoic acid) and FDG(fluoro-2- deoxy-glucose).
16176711|NCT01572064|Procedure|Blood sample|1 fasted blood sample taken for metabolomics
16176712|NCT01572064|Other|MRI Scan|1 single visit for MRI and MRS
16176713|NCT01572051|Behavioral|Educational Course|2 Educational courses
16176714|NCT01572051|Behavioral|Phone Calls|Phone Calls
16176715|NCT01572051|Behavioral|Printed Material|Printed Material
16176716|NCT01572038|Drug|Docetaxel|Participants may receive 'docetaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.
16176717|NCT01572038|Drug|Nab-paclitaxel|Participants may receive 'nab-paclitaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.
16176718|NCT01572038|Drug|Paclitaxel|Participants may receive 'paclitaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.
16176719|NCT01572038|Drug|Pertuzumab|Participants will receive pertuzumab 840 milligrams (mg) IV on Day 1 or Day 2 of Cycle 1, followed by 420 mg IV on Day 1 or Day 2 of each subsequent 3-week cycle.
16176720|NCT01572038|Drug|Trastuzumab|Participants will receive trastuzumab (Herceptin) 8 milligrams per kilogram (mg/kg) IV on Day 1 or Day 2 of Cycle 1, followed by 6 mg/kg IV on Day 1 or Day 2 of each subsequent 3-week cycle, administered in line with the respective product Information and/or recognized clinical practice guidelines.
16176721|NCT01572025|Drug|Dehydroepiandrosterone|"Dehydroepiandrosterone (DHEA)(St Mary's Pharmaceutical Unit Cardiff and Vale) DHEA 75 mg capsule. 1 capsule taken once daily for at least 12 weeks prior commencing ovarian stimulation protocol
~: Stimulation protocol standard long down-regulation protocol, using human menopausal gonadotropin (HMG)"
16176722|NCT01572025|Drug|Placebo|"Matched Placebo containing no active ingredient. 1 capsule taken once daily for at least 12 weeks prior commencing ovarian stimulation protocol
~: Stimulation protocol standard long down-regulation protocol, using human menopausal gonadotropin (HMG)"
16176723|NCT01572012|Drug|Ondansetron|Ondansetron solution 4 mg single administration
16176724|NCT01572012|Drug|Ondansetron + Hylenex|Ondansetron solution (4 mg) single administration + Hylenex recombinant (150 U) single administration
16176725|NCT01572012|Drug|Zofran ODT|Zofran ODT (8 mg) single administration
16176726|NCT01572012|Drug|Ondansetron solution|Ondansetron solution (4 mg) single administration
16176727|NCT01571999|Drug|Inhaled GSK573719|All subjects will receive a single dose of GSK573719 (125mcg) in treatment period 1
16176728|NCT01571999|Drug|Inhaled GSK573719/vilanterol|All subjects will receive a single dose of GSK573719 (125mcg)/vilanterol (25mcg) in treatment period 2
16176729|NCT01571986|Procedure|Non-invasive ventilation|Non-invasive ventilation
16176730|NCT01571973|Procedure|pharmacotherapeutic follow-up|health education adjustment of dose improve compliance replacement of medication
16176731|NCT01571960|Biological|GEO-D03 DNA vaccine|Either a 0.3-mg (Group 1: study vaccine) or 3-mg dose (Groups 2 and 3: study vaccine) administered as a 1-mL IM injection into the deltoid
16176732|NCT01571960|Biological|MVA/HIV62B (MVA62B) vaccine|1 x 10^8-TCID50 dose of MVA62B vaccine, administered as a 1-mL IM injection into the deltoid
16176733|NCT01571960|Biological|Placebo for GEO-D03 DNA|Administered as a 1-mL IM injection into the deltoid
16176734|NCT01571960|Biological|Placebo for MVA62B:|Administered as a 1-mL IM injection into the deltoid
16176735|NCT01571947|Other|Acute Effects of Fats and Carbohydrate|Test meals were served in the form of muffin + milkshake. For high fat meals, 55g of test fat will be incorporated in muffins, whereas 22g of fat for low fat or high carbohydrate test meal. During study day, subjects were to consume the allocated test meal within 10 minutes.
16176736|NCT01571921|Dietary Supplement|Gamma-Delta Tocotrienol and Tocotrienol Rich Fraction|Single oral TRF or Gamma-Delta Tocotrienol dosage
16176737|NCT01571908|Drug|Magnesium perfusion|The patient receives during 15 minutes a perfusion of 60mg/kg of Magnesium sulphate before induction of anaesthesia.
16176738|NCT01571908|Drug|Rocuronium|Immediately after anaesthesia induction and loss of consciousness 0,6 mg/kg of rocuronium will be injected
16176739|NCT01571908|Drug|Placebo perfusion|The patient receives during 15 minutes a perfusion of 1 ml/kg of saline before induction of anaesthesia
16176740|NCT01571908|Drug|Succinylcholine|Immediately after anaesthesia induction at loss of consciousness 1 mg/kg of succinylcholine will be injected
16176741|NCT01571895|Drug|DF2156A|DF2156A is a novel small molecule that inhibits the biological activity of the CXC ligand 8 [CXCL8; formerly interleukin (IL)-8] through inhibition of the activation of CXCL8 receptors: CXCR1 and CXCR2. This specific inhibitor stems from a program of drug design of molecules intended to modulate chemokine action.
16176742|NCT01571882|Other|1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 10 mg of policosanols per unit|1- Intervention with test product ( 1.6g of plant sterol + 10 mg of policosanols/ day)
16176743|NCT01571882|Other|2- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) + 20 mg of policosanols per unit|2- Intervention with test product (1.6g of plant sterol + 20 mg of policosanols/day)
16176744|NCT01571882|Other|3- Low fat drinkable fermented dairy product with 1.6g of plant sterol (as free equivalent) but without policosanols (Active control)|3- Intervention with active control product (1,6 g of plant sterol/ day)
16176745|NCT01571869|Other|1- Low fat drinkable fermented dairy product enriched with 1.6g of plant sterol (as free equivalent) per unit|1-Intervention with test product (morning, evening or snack)
16176746|NCT01571869|Other|2- Low fat drinkable fermented dairy product without plant sterols (control)|2 - Intervention with control product (morning and/or evening)
16176747|NCT01571856|Drug|Zinc Sulfate|zinc sulfate solution, contains 20 mg. per 5 mL. dosage 2.5 mL. per day.
16176748|NCT01571856|Other|placebo|cornstarch powder diluted in distilled water, dosage 2.5 ml per day
16176749|NCT01571843|Other|Forearm exercise program|Participants assigned to forearm exercise will receive training in forearm strengthening exercises from a doctoral occupational therapy student. Participants will be taught 8 exercises and are performed at home. The exercise program is designed to take about 30 minutes per session.
16176750|NCT01571843|Other|Walking program|Walking will consist of 30 minutes at a moderate pace every other day for 52 weeks. The walking program for all participants constitutes the control/placebo comparator.
16176751|NCT01571817|Biological|Isolated Human Pancreatic Islets|
16176752|NCT01571804|Drug|Placebo|to receive two identical placebo capsules 1 hr before surgery
16176753|NCT01571804|Drug|pregabalin|one capsule of pregabalin 150 mg and one placebo capsule 1 hr before surgery
16176754|NCT01571804|Drug|pregabalin|two capsules of pregabalin 150 mg 1 hr before surgery
16176755|NCT01571791|Drug|Placebo|to receive saline infusion and intravenous fentanyl boluses, at 30 min before induction of anesthesia
16176756|NCT01571791|Drug|Ketorolac-Lidocaine|receive ketorolac-lidocaine infusion and intravenous saline boluses , at 30 min before induction of anesthesia
16176757|NCT01571778|Behavioral|Hand Hygiene before Donning Non-sterile Gloves|"In the No Intervention arm, healthcare workers will be assigned to first perform hand hygiene before donning non-sterile gloves prior to patient contact (usual practice). Samples will be obtained from hands prior to donning gloves and from the gloves after donning to determine total aerobic colony counts and to identify important hospital pathogens
~In the Experimental arm, they will be instructed to don gloves without washing their hands as described."
16176758|NCT01571765|Other|MNCH programming in health district|training at health district level in management, data collection. Training at health centres in obstetrics and pediatrics and training in community of CHWs and bednet distribution
16176759|NCT01571726|Drug|Fluciclatide|7mCi
16176760|NCT01571700|Procedure|Catheterization Pacing|The second part of the study will include patients with pulmonary hypertension >5 who are scheduled for a cardiac catheterization for clinical reasons. We will at the conclusion of the routine catheterization, place two pacing catheters within the right atrium and right ventricle and pace the heart at a rate approximately 10% higher than sinus rhythm for 5 minutes. We will then measure dP/dT max in the ventricles, blood pressure and cardiac output using a Fick equation to assess hemodynamics. We will repeat this 3 times using different sites in the right ventricle while simultaneously obtaining echoes to assess mechanical synchrony.
16176761|NCT01571687|Dietary Supplement|antioxidant supplements|Intake of 6 tablets daily containing: 800 I.E. Vitamin E, 1000mg Vitamin C, 200000 I.E. Vitamin A, 600mg Acetylcystein.
16176762|NCT01571687|Dietary Supplement|Placebo|Intake of 6 identically appearing tablets daily containing placebo
16176763|NCT01571674|Procedure|Manipulation + Exercise Group|"First 2 sessions
~High-velocity, low-amplitude manipulations to the thoracic spine.
~Low-velocity mid to end-range mobilizations to the cervical spine.
~Active Range of Motion Exercises for the cervicothoracic spine
~Final 6 sessions
~◦ Evidence based shoulder girdle exercise program"
16176764|NCT01571674|Procedure|Exercise Group|"First 2 sessions
~◦ Active Range of Motion Exercises for the cervicothoracic spine
~Final 6 sessions
~◦ Evidence based shoulder girdle exercise program"
16176765|NCT01571661|Drug|GSK189075A|20mg, 50mg, 150mg, 500mg, 1000mg or Placebo
16176766|NCT01571661|Other|Placebo|Placebo
16176767|NCT01571648|Drug|Oral azacitidine|Patients will receive 300 mg dose of oral azacitidine administered once daily for the first 21 days of each 28-day treatment cycle.
16176768|NCT01571635|Drug|SOTATERCEPT (ACE-011)|0.1 mg/kg to 1.5mg/kg Sotatercept will be administered as a subcutaneous injection once every 21 days during the treatment period.
16176769|NCT01571622|Dietary Supplement|Whey before Breakfast|After consumption of whey before breakfast samples will be taken every 30 minutes for quantification of glucose, insulin, GlP-1 and GIP
16176770|NCT01571622|Dietary Supplement|Water before breakfast|After water before breakfast the blood samples will be taken every 30 min for quantification of glucose, insulin, GLP-1 and GIP,
16176771|NCT01571609|Other|first phase insulin secretion (FPIR), Hyperinsulinemic euglycemic clamp (HEC), glucose tracer, and palmitate tracer|"FPIR: intravenous infusion of 20 % glucose 0.3 mg/kg in 2 minutes followed by blood sampling at times 0, 2, 4, 6, 8, and 10. Duration 10 minutes.
~HEC: intravenous infusion of actrapid 1mU/kg/minute, simultaneous infusion of 20 % glucose at variable rate to reach plasma blood glucose level of 5 mmol/L. Duration 120 minutes
~Glucose tracer: bolus of 3H3glucose (12µCi) followed by infusion of 3H3glucose (0,12 µCi/min). Duration 120 minutes.
~Palmitate tracer:[9,10-3H]-palmitate 0,3 µCi/min. Duration 60 minutes."
16176772|NCT01571596|Drug|KRN23|Subjects will receive escalating doses of KRN23 administered by SC injection every 28-days (up to 12 doses) based on a dosing algorithm and discretion of Investigator and Sponsor.
16176773|NCT01571583|Drug|Telaprevir|Type=exact number, unit=mg, number=375, form=tablet, route=oral. Patients will receive 2 oral tablets (750 mg) every 8 hours for 12 weeks.
16176774|NCT01571583|Drug|Pegylated interferon alfa-2a|Type=exact number, unit=µg, number=180, form=injection, route=subcutaneous. 180 microgram (µg) per week, subcutaneous injection, for 48 weeks.
16176775|NCT01571583|Drug|Ribavirin|Type=exact number, unit=mg, number=200, form=tablet, route=oral. Starting from 600 mg (3 tablets) per day on Day 1. This dose will become higher or lower based on blood results and the investigators opinion (to a goal of 1000 to 1200 mg/day [5 to 6 tablets] based on subject weight), twice daily regimen, for 48 weeks.
16182250|NCT01529528|Drug|Anagliptin|Anagliptin 100mg, tablet, BID
16176779|NCT01571570|Drug|TMC435 150 mg capsule concept K|single oral dose of 150 mg TMC435 capsule concept K
16176780|NCT01571570|Drug|TMC435 150 mg capsule concept L|single oral dose of 150 mg TMC435 capsule concept L
16176781|NCT01571557|Drug|dexamethasone 700 ug intravitreal implant|dexamethasone 700 ug intravitreal implant administered according to standard of care.
16176782|NCT01571544|Device|Thermal suit|Thermal suit
16176783|NCT01571544|Other|Conventional clothing|Conventional clothing
16176784|NCT01571518|Drug|late leukostim|injection of G-CSF (leukostim)5㎍/kg from day 5 of TAC chemotherapy
16176785|NCT01571518|Drug|early leukostim|injection of G-CSF (leukostim)5㎍/kg from day 2 of TAC chemotherapy
16176786|NCT01571505|Biological|IPV vaccination|Randomized IPV or OPV to children aged at 39weeks.
16176787|NCT01571492|Procedure|L2 Paravertebral catheter nerve block|A continuous L2 paravertebral catheter will be placed according to UPMC standard of care practices.
16176788|NCT01571492|Procedure|Continuous Lumbar plexus nerve block|A continuous unilateral lumbar plexus catheter will be placed according to UPMC standard of care practices.
16176789|NCT01571479|Procedure|2- mini-instrument|"The patient was positioned in the supine position with the head and right side up.
~Under general anesthesia, pneumoperitoneum (12 mmHg) was established after an 11-mm port was placed through 11-mm transumbilical incision by the open method.
~A 10-mm 0-degree laparoscope was inserted through this umbilical port. A 5-mm trocar was then placed in the epigastric area, and the surgeon determined through 'laparoscopic surgical view' whether the 2-mm mini-instrument could be used as the right subcostal port . If the 2-mm mini-instrument could be used as the right subcostal port, a 2-mm trocar was inserted . If not, a 5-mm trocar was inserted for the right subcostal port. Therefore, this point is the unique difference between the two groups."
16176790|NCT01571466|Drug|Vaccination|"Modified Pox virus, strain MVA clade -B (expressing HIV-1 Bx08gp120 and IIIB gagpolnef)
~-~ 1 x 10e8 pfu/ml
~3 immunisations at week 0, 4 and 16"
16176791|NCT01571466|Drug|Placebo|3 immunisations at week 0, 4 and 16
16176792|NCT01571453|Drug|Vortioxetine (Lu AA21004)|10 mg/day
16176793|NCT01571453|Drug|Venlafaxine extended release|150 mg/day
16176794|NCT01571440|Dietary Supplement|No soluble corn fiber|Each teen will receive a package of fruit snacks containing 0 g soluble corn fiber two times per day
16176795|NCT01571440|Dietary Supplement|12 g soluble corn fiber|Each teen will receive a package of fruit snacks containing 6 g soluble corn fiber two times per day.
16176796|NCT01571427|Behavioral|Active social engagement group|Engage in 30 minutes conversation daily using internet/webcam, 5 days per week for 6 weeks, tracking of daily conversational amount outside of the trial by using a digital recording device, lasting effects will be assessed at the 3rd and 6th month after completion of the intervention
16176797|NCT01571427|Behavioral|Control group|No active intervention, weekly phone calls by interviewer to complete health/social engagement monitoring survey, tracking of daily conversational amount by using a digital recording device. Participants will be reassessed at the 3rd and 6th month after completion of the intervention.
16176798|NCT01571414|Drug|PA-824|200-mg tablets once a day
16176799|NCT01571414|Drug|Efavirenz (EFV)|600-mg tablets once a day
16176800|NCT01571414|Drug|Lopinavir/Ritonavir (LPV/r)|400-mg/100-mg tablets twice a day
16176801|NCT01571414|Drug|Rifampin (RIF)|300-mg capsules once a day
16176802|NCT01571401|Behavioral|Trying Activity for Kidney Cancer Survivors (TRACKS) Trial|Participants in both arms will be provided with six individual supervised exercise sessions with a physical activity specialist that will taper to an unsupervised program by the end of the intervention. Over the 4-week period, both groups will be required to attend two sessions per week for weeks 1-2, and one session per week for weeks 3-4 at the Behavioural Medicine Fitness Centre at the University of Alberta. In order to achieve the PA guidelines established by the current public health recommendations, additional unsupervised sessions will be prescribed.
16176803|NCT01571388|Drug|dacomitinib|Subjects to receive 30 mg tablets of dacomitinib on Day 1 of Period 1.
16176804|NCT01571388|Drug|dacomitinib|Subjects to receive 30 mg tablets of dacomitinib on Day 1 of Period 1.
16176805|NCT01571388|Drug|dacomitinib|Subjects to receive 30 mg tablets of dacomitinib on Day 1 of Period 1.
16176806|NCT01571362|Drug|ALO-02|20 to 160mg total daily dose of oxycodone, divided into symmetric doses and administered twice daily
16176807|NCT01571362|Drug|Placebo|oral placebo, divided into symmetric doses and administered twice daily
16176808|NCT01571323|Drug|Misoprostol|The misoprostol group (groupM) received 400 µg sublingually and infusion of lactated Ringer ( which one ampoule placebo dissolved it)
16176809|NCT01571323|Drug|Oxytocin|The oxytocin group(group O) received intravenous infusion of 20 units of oxytocin soon after delivery of the neonate and one tablet of placebo sublingually. (20 IU syntocinon dissolved in 1liter of lactated Ringer's solution) at the rate of 1000 ml over a 1h period, immediately after delivery of the neonate
16176810|NCT01571323|Drug|Oxytocin and Misoprostol|The combined misoprostol-oxytocin group(group MO) received 200 µg and 5 iu oxytocin bolus intravenously immediately after delivery of the neonate .
16176811|NCT01571310|Other|Omitted Breakfast|Experimental:The patients in Omitted Breakfast day will omit the breakfast and will continue the overnight fast until lunch. They will eat only lunch (700 kcal) at 13:30 and dinner (700 kcal) at 19:00
16176812|NCT01571310|Other|Breakfast|"In the Active Comparator: The patients in the Breakfast day will consume breakfast (700 kcal) at 8:00 , lunch (700 kcal) at 13:30 and dinner (700 kcal) at 19:00
~(YesB): The patients in YesB will eat all three mealswill consume three meals:"
16176813|NCT01571297|Drug|RM-131|Double blind RM-131 will be studied with various doses and regimens from 10 to 100 μg for 35 days.
16176814|NCT01571297|Drug|Placebo|Placebo given subcutaneously for 35 days
16176815|NCT01571284|Drug|AFLIBERCEPT AVE0005|Pharmaceutical form:Concentrate for solution for infusion Route of administration: Intravenous
16176816|NCT01571284|Drug|FOLFIRI|irinotecan, 5-FU and leucovorin
16176817|NCT01571271|Procedure|Laser Lithotripsy|Laser Lithotripsy
16176818|NCT01571271|Procedure|Electrohydraulic Lithotripsy|Electrohydraulic Lithotripsy
16176819|NCT01571258|Behavioral|Text Messaging|Participants in the intervention group will receive on average 4 texts per day consisting of weight related behavioral recommendations, knowledge based questions, and prompts to promote physical activity and weight monitoring. Texts are interactive and personally relevant based upon a baseline questionnaire.
16176820|NCT01571232|Drug|dexamethasone intravitreal implant|Ozurdex, 0.7 mg intravitreal dexamethasone implant, given at initial visit and at month 4 (visit 5)
16176821|NCT01571232|Drug|intravitreal bevacizumab|Avastin, 1.25 mg intravitreal bevacizumab, given at initial visit and Q1month for a total of 5 treatments.
16176822|NCT01571219|Biological|Infliximab|CT-P13(3mg/kg) administered as a 2-hour IV infusion per dose co-administered with methotrexate between 12.5 to 25 mg/week, oral or parenteral dose (dose and route must be maintained from Study CT-P13 3.1 and be maintained from the beginning to the end of the extension study) and folic acid(≥5mg/week, oral dose)
16176823|NCT01571206|Biological|Infliximab|CT-P13 (5mg/kg) administered as a 2-hour IV infusion per dose
16176824|NCT01571167|Drug|Placebo|Participants will receive varenicline or matched placebo from day 1 through day 7, then the same subjects will return within 2-4 weeks and assigned to each of the two remaining study medication conditions, and undergo the identical procedures (3-phase study).
16176825|NCT01571167|Drug|Varenicline|For varenicline 1 mg, dosing will begin at 0.5 mg once daily (with 0 mg placebo to maintain blind of bid dosing) for days 1-3, will be increased to 0.5 mg twice daily for the days 4-6, and then reduced to 0.5 mg once daily on day 7. No medication is given on Day 8.
16176826|NCT01571167|Drug|Varenicline|For varenicline 2 mg, dosing will begin at 0.5 mg once daily for days 1-3 (with 0 mg placebo to maintain blind of bid dosing), will be increased to 0.5 mg twice daily for day 4, and increased to 1 mg twice daily on days 5-6, and then reduced to 1 mg once daily on day 7. No medication is given on Day 8.
16176827|NCT01571141|Device|Monogin|Gynaecological solution with polyhexamethylene biguanide, pH 4.0
16176828|NCT01571128|Other|Male-Specific Intervention Package|Combination HIV Prevention: Male-Specific Intervention Package at the Mobile Health events and longitudinal follow up of cohorts.
16176829|NCT01571128|Other|Female-Specific Intervention Package|Combination HIV Prevention: Female-Specific Intervention Package at the Mobile Health events and longitudinal follow up of cohorts.
16176830|NCT01571128|Drug|Pre-Exposure Prophylaxis (Females)|Females 18-24 who are out of school.
16176831|NCT01571128|Behavioral|Cash Transfer Cohort (Females)|Cash transfer for females (and their parents) who are aged 15-24 and enrolled in school.
16176832|NCT01571115|Behavioral|Physical Exercise|
16176833|NCT01571102|Behavioral|Therapy|week 1 - 4: 3 times/week, week 5 - 8: 2 times/week, duration 40min.
16176834|NCT01571102|Behavioral|Exercise therapy|week 1 - 4: 3 times/week, week 5 - 8: 2 times/week, duration 30 min.
16176835|NCT01571089|Behavioral|DBT-inspired anxiety treatment|In short, the treatment is 24 sessions consisting of skills-training strategies and exposure strategies. The idea is that the patient during the treatment will learn and practice the skills needed to handle exposures.
16176836|NCT01571076|Genetic|PGS|Preimplantation Genetic Screening of the embryos and posterior transfer of ongoing Day 5 blastocysts.
16176837|NCT01571076|Genetic|PGS|Preimplantation Genetic Screening of the embryos and posterior transfer of ongoing Day 5 blastocysts.
16176838|NCT01571076|Other|Prolonged culture|The embryos will be in prolonged culture and on going embryos transferred on Day 5 .
16176839|NCT01571076|Other|Prolonged culture|Prolonged culture of the embryos and posterior transfer of ongoing Day 5 blastocysts.
16176840|NCT01571063|Drug|Vitamin D3|Vitamin D3, 2.100 IU/d p.o.
16176841|NCT01571063|Drug|Placebo|Placebo Tbl. p.o.
16176842|NCT01571050|Drug|Purified water|Ingestion of 30 mL of purified water
16176843|NCT01571050|Drug|Fresh MFP/CaCO3 toothpaste|Ingestion of 31.9 mg of a fresh toothpaste containing 1450 ppm total fluoride per kg body weight, diluted in 30 mL of purified water, to provide a total intake of 49.5 ug of fluoride/kg body weight.
16176844|NCT01571050|Drug|Fresh NaF/SiO2 toothpaste|Ingestion of 49.5 mg of a fresh toothpaste containing 1100 ppm total fluoride per kg body weight, diluted in 30 mL of purified water, to provide a total intake of 49.5 ug of fluoride/kg body weight.
16176845|NCT01571050|Drug|Aged NaF/SiO2 toothpaste|Ingestion of 49.5 mg of a toothpaste containing 1100 ppm total fluoride per kg body weight, diluted in 30 mL of purified water, to provide a total intake of 49.5 ug of fluoride/kg body weight. The toothpaste had been previously aged to simulate one year storage at room temperature.
16176846|NCT01571050|Drug|Aged MFP/CaCO3 toothpaste|Ingestion of 31.9 mg of a toothpaste containing 1450 ppm total fluoride per kg body weight, diluted in 30 mL of purified water, to provide a total intake of 49.5 ug of fluoride/kg body weight. The toothpaste had been previously aged to simulate one year storage at room temperature.
16176847|NCT01571037|Drug|Inhaled, nebulized, Milrinone|1 mg/ml milrinone (dissolved in dextrose) and diluted in 0.9% normal saline in a 1:1 ratio to final drug concentration of 0.5mg/ml will be delivered via an IV pump at a fixed dose of 12 ml/hour which will run into a vibrating mesh nebulizer reservoir, connected to the mechanical ventilator circuit. Inhaled milrinone will begin at time of resumption of mechanical ventilation when initiating wean from cardiopulmonary bypass after LVAD implantation in the operating room, and run continuously for a total maximum duration of 24 hours OR until the patient is extubated whichever occurs first. Plasma milrinone levels will be assessed to determine if systemic milrinone absorption occurs after prolonged milrinone inhalation.
16176848|NCT01571037|Drug|inhaled nebulized milrinone|0.5 mg/ml inhaled nebulized milrinone deliver at 12 ml/hr continuously until either 24 hours or extubated.
16176849|NCT01571024|Drug|BKM120|BKM120 40 mg, orally, once daily.
16176850|NCT01571024|Drug|mFOLFOX6|mFOLFOX6 treatment will be as follows: Oxaliplatin: 85 mg/m2 IV, Leucovorin: 400 mg/m2 IV, 5FU bolus: 400 mg/m2 IV and 5FU infusion: 2400 mg/m2 IV.
16176851|NCT01571011|Behavioral|CURB|The intervention is made up of 14 internet modules based on behavioral activation, cognitive behavioral therapy, and interpersonal psychotherapy as well as motivational interviews in the primary care setting (to enhance behavior change). It is suggested that an adolescent navigates through 2 modules a week. The motivational interviews with the physicians occur directly before and after the adolescent is exposed to the website (at baseline and 3 months) in the providers office. The parents of the enrolled adolescents are also invited to navigate through their own, 3 module, parent internet program.
16176852|NCT01570998|Radiation|Intraoperative Radiation Therapy|Undergo IORT
16176853|NCT01570998|Other|Laboratory Biomarker Analysis|Correlative studies
16176854|NCT01570985|Drug|Triamcinolone Acetonide|Triamcinolone 20 mg intraarticular injection with Lidocaine 10mg/ml 3 ml and variable amount of saline of 4 ml solution on day 1, day 7, day 17 and day 31st.
16176855|NCT01570985|Drug|Triamcinolone Acetonide|Patients in group 2 will receive intraarticular Triamcinolone 20 mg, 3 ml Lidocaine and physiological natrium chloride 9 mg/ml, comprising a total volume from 8 ml and upwards up to 20 ml
16176856|NCT01570972|Behavioral|Group Cognitive Behavioral Therapy|weekly
16176857|NCT01570972|Behavioral|Multifamily Group Psychoeducation|twice monthly
16176858|NCT01570959|Drug|Quetiapine Fumarate|300 mg tablet
16176859|NCT01570946|Behavioral|Lifestyle Modification|The mobile phone based intervention will use short messaging service (SMS or text messaging) to deliver education, treatment targets, advice, support and motivation.
16176860|NCT01570933|Device|NivNava|Non-invasive Nava ventilation mode on nasal cannula
16176861|NCT01570933|Device|Cpap|nasal Cpap on nasal cannula
16176862|NCT01570920|Behavioral|physical training|walking many times a week
16176863|NCT01570907|Drug|Quetiapine Fumarate|25 mg tablet
16176864|NCT01570894|Drug|Quetiapine Fumarate|25 mg tablet
16176865|NCT01570868|Drug|Ponatinib|Starting dose: 45 mg by mouth once daily.
16176866|NCT01570842|Other|Anthropometric measurements|All participants will have their waist circumference and waist to hip ratio taken as a measurement of central obesity.
16176867|NCT01570842|Procedure|Tissue samples|Participants undergoing clinically indicated upper endoscopy and who consent to providing tissue samples will have 8 tissue samples taken for future research purposes.
16176868|NCT01570829|Drug|Dietressa|Oral administration.
16176869|NCT01570829|Drug|Placebo|Oral administration.
16176870|NCT01570816|Device|IRS-8 (8 channel implanted receiver stimulator)|Surgical implantation of an 8 channel pulse generator to stimulate paralyzed muscles of the lower extremities
16176871|NCT01570803|Device|S.M.A.R.T CONTROL Stent|Provisional stenting should be performed; the case that optimal ballooning response is not obtained (sub-optimal balloon response) should be enrolled. The procedure is usually done, as follows; After the guidewire is passed through the target lesion, predilation of the target lesion with an optimally sized balloon will be performed prior to stent implantation. Recommended, minimal balloon dilation time is 120 seconds. The sub-optimal balloon response is defined as a residual pressure gradient of >15 mmHg, residual stenosis of >30%, and flow-limiting dissection.
16176872|NCT01570803|Device|Complete SE Stent|same to SMART CONTROL Stent
16176873|NCT01570790|Drug|Combretastatin A-4 phosphate|27 mg/m2 CA4P IV infusion at baseline and every week for 4 doses
16176874|NCT01570790|Drug|Combretastatin A-4 Phosphate|36 mg/m2 CA4P IV infusion at baseline and every week for 4 doses
16176875|NCT01570790|Drug|Combretastatin A-4 Phosphate|45 mg/m2 CA4P IV infusion at baseline and every week for 4 doses
16176876|NCT01570777|Procedure|renal denervation and optimized medication regimen|Patients are treated with the renal denervation plus a standardized optimal antihypertensive treatment which is adapted every month starting two month after randomization on the basis of home BP monitoring results at follow-up visits.
16176877|NCT01570777|Procedure|optimized medication regimen|Patients are treated with a standardized optimal antihypertensive treatment which is adapted every month starting two month after randomization on the basis of home BP monitoring results at follow-up visits.
16176878|NCT01570764|Drug|Cyclophosphamide|Prednisone 15 mg/d + monthly pulse cyclophosphamide 700 mg/m ² diminished to 600 mg/m ² in patients over 65 years or having a creatinine clearance lower than 30 ml/min for 12 months.
16176879|NCT01570764|Drug|Placebo|Prednisone 15 mg/d + monthly pulse of placebo of cyclophosphamide. The posology and the methods of administration of the placebo of cyclophosphamide (NaCl) will be the same as those used for cyclophosphamide
16176880|NCT01570751|Drug|insulin degludec|Cross-over trial, part 1: Individually adjusted IDeg administered subcutaneously (s.c., under the skin) once daily for 16 weeks in each treatment period.
16176881|NCT01570751|Drug|insulin glargine|Cross-over trial, part 2: Individually adjusted IGlar administered subcutaneously (s.c., under the skin) once daily for the 16 week run-in period followed by 16 weeks in each treatment period.
16176882|NCT01570725|Behavioral|Virtual reality exposure|"The Green Valley, a non interactive, relaxing environment showing a mountain landscape around a calm lake is presented to the patient together with the relaxing music and soft sounds (birds' songs, the water flowing, etc). Having the impression of walking around the lake, patients can observe the nature and virtually seat on a comfortable deck chair, in order to become easily relaxed.
~Patients were exposed to the virtual environment for the entire length of the operation."
16176883|NCT01570725|Behavioral|Music only|A relaxing music and nature sounds have been used to provide a calm atmosphere and reduce stress. In the Music group it was provided to the patients through earphones with no visual stimulation.
16176884|NCT01570712|Other|HOUSING FIRST PROGRAM|"Realization of a psychosocial organic evaluation and a citizen;
~Support in the development and the maintenance of the housing;
~Support in the diverse steps (administrative, judicial, financiers, etc.);
~Support around addictions / alcohol;
~Supportin the family and social relations, in the environment of the person -to favor the occupational integration, by prioritizing the insertion in ordinary environment(middle)
~to favor the access and the preservation of the patient to the psychiatric and somatic care, to the devices and the departments favoring the social insertion and the integration."
16176885|NCT01570712|Other|traditional French services|"The person will not receive from intervention of the team of site, but the person can resort(turn) without limitation to all the range of services said  about common law  set up in the direction of the persons homeless persons, as well as to every type of care. She can too reach the housing and\or the restoring, but this by means of the existing devices"
16176886|NCT01570699|Genetic|COMT polymorphism|The COMT enzyme enables the degradation of brain monoamines such as Dopamine and is encoded by a single gene for which several polymorphisms are known, including the Val158Met polymorphism which has been widely studied in various psychiatric disorders including addictions, as well as in impulsivity
16176887|NCT01570686|Drug|Aliskiren|Aliskiren 300 mg once daily
16176888|NCT01570673|Behavioral|Group urotherapy|Children in this arm will receive group urotherapy in small groups with other children.
16176889|NCT01570673|Behavioral|Individual Urotherapy|Children will receive standard individual urotherapy in regular pediatric urology clinic.
16176890|NCT01570660|Drug|Pioglitazone|12 weeks of pioglitazone treatment
16176891|NCT01570634|Drug|Calcium Aluminosilicate Anti-Diarrheal (CASAD)|CASAD 3 500mg capsules po tid for 14 days with 4 weeks of follow up
16176892|NCT01570621|Procedure|peroral endoscopic myotomy|A 3-cm incision is made into the mucosa after injection of saline and methylene blue. A submucosal tunnel is created from the mid-esophagus to the gastric cardia by a triangle-tip knife. The circular muscle fibers or full-thickness muscle are divided by the triangle-tip knife over a length of 6-20 cm on the esophagus, starting 3 cm below the initial mucosal incision, and extended 3-4cm onto the gastric cardia. The mucosal entry site is closed using standard endoscopic clips at last.
16176893|NCT01570608|Drug|Ranibizumab|intravitreal injection 3 monthly injections thereafter as needed
16176894|NCT01570608|Drug|Verteporfin|Verteporfin photodynamic therapy standard fluence
16176895|NCT01570595|Behavioral|Web-Based Tailored Smoking Cessation Intervention|"The Experimental group will be given an ID number to log in to the quit smoking program, and complete their first log-in with a research assistant. The online program is made up of 8 separate, weekly online sessions that take approximately 15-30 minutes to complete. The entire program is meant to be completed in 7 weeks. Participants are asked to provide an email address and/or cell phone number so reminders can be sent to complete the sessions. If participants are late completing a session, they will receive a call from clinic staff as a reminder. The standard care group will receive advice to quit, a quit-smoking brochure, and an offer of three months of nicotine replacement therapy (nicotine patches)."
16176896|NCT01570595|Behavioral|Standard of Care|advice to quit, a quit-smoking brochure, and an offer of three months of nicotine replacement therapy (nicotine patches).
16176897|NCT01570582|Drug|carboplatin and paclitaxel|Subjects assigned to Arm I Neople taksoljuwa Latin week the first day of the week based outpatient / inpatient treatment receive it. The subjects first received taksoljureul given over 3 hours followed by 30 minutes will be administered Neople Latin week.
16176898|NCT01570569|Drug|Omeprazole|Thirteen healthy male subjects were given oral doses of 200 μg omeprazole, 2 mg losartan and 2 mg dextromethorphan individually and in combination of five drugs (cocktail) every other days.
16176899|NCT01570569|Drug|Losartan|Thirteen healthy male subjects were given oral doses of 200 μg omeprazole, 2 mg losartan and 2 mg dextromethorphan individually and in combination of five drugs (cocktail) every other days.
16176900|NCT01570569|Drug|Dextromethorphan|Thirteen healthy male subjects were given oral doses of 200 μg omeprazole, 2 mg losartan and 2 mg dextromethorphan individually and in combination of five drugs (cocktail) every other days.
16176901|NCT01570569|Drug|Cocktail|"Group A : Thirteen healthy male subjects were given oral doses of 200 μg omeprazole, 2 mg losartan and 2 mg dextromethorphan individually and in combination of five drugs (cocktail) every other days.
~Group B : Thirteen healthy male subjects received 100 μg midazolam and 2 mg caffeine individually followed by five-drugs cocktail every two days."
16176902|NCT01570569|Drug|Midazolam|Thirteen healthy male subjects received 100 μg midazolam and 2 mg caffeine individually followed by five-drugs cocktail every two days.
16176903|NCT01570569|Drug|Caffeine|Thirteen healthy male subjects received 100 μg midazolam and 2 mg caffeine individually followed by five-drugs cocktail every two days.
16176904|NCT01570556|Other|Antibiotic treatment|In patients with positive urinary culture, seven days of antibiotics will be given orally according to the bacteriogram sensitivity.
16176905|NCT01570530|Procedure|Cardiac surgery|Atorvastatin therapy as prophylaxis against postoperative atrial fibrillation after cardiac surgery
16176906|NCT01570530|Procedure|Cardiac surgery|Without atorvastatin therapy as prophylaxis against postoperative atrial fibrillation after cardiac surgery
16176907|NCT01570517|Device|IASD System|Implantation of the DC Devices Inc. IASD System
16176908|NCT01570504|Drug|Ivermectin|oral formulation
16176909|NCT01570491|Other|ultrasound-guided spinal anesthesia|ultrasound-guided technique for block placement
16176910|NCT01570491|Other|standard spinal anesthesia|Anesthesiologist will use standard technique for placement of spinal block.
16176911|NCT01570478|Drug|Foster® NEXThaler® 100/6 µg/unit dose|Foster® NEXThaler® (beclomethasone dipropionate 100 µg plus formoterol 6 µg per actuation), 2 inhalations b.i.d. (daily dose of BDP 400 µg plus FF 24 µg)
16176912|NCT01570478|Drug|Seretide® Accuhaler® 250/50 µg/actuation|Seretide® Accuhaler® (fluticasone propionate 250 μg plus salmeterol xinafoate 50 μg per actuation), 1 inhalation b.i.d. (daily dose of fluticasone 500 μg plus salmeterol 100 μg)
16176913|NCT01570465|Other|Observation|Assess the impact of each type of severe infections (SI) over the 24-month overall survival of young patients with newly diagnosed acute myeloid leukemia along a predefined antileukemic treatment strategy.
16176914|NCT01570452|Procedure|colonic or colorectal resection|standard laparotomic resection of colon-rectum including right hemicolectomy, left hemicolectomy, sigmoidectomy, anterior resection
16176915|NCT01570413|Procedure|No Pelvic Exam|Will not receive pelvic examination.
16176916|NCT01570413|Procedure|Pelvic Examination|Pelvic examination will be performed.
16176917|NCT01570400|Behavioral|Internet-administered cognitive behavioral therapy (iCBT)|Established form of internet-administered cognitive behavioral therapy. Controlled progress, self-help modules with psychoeducative texts, assignments and homework. Therapist assisted.
16176918|NCT01570400|Behavioral|Cognitive bias modification training program variant 1|"Computerized, internet-based training program for implicit modification of cognitive bias of attention, variant 4. Participant is exposed to a pair of words or a pair of faces -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (< or >) in the previous position of ONE of these words or faces and is then asked to press the corresponding arrow button on a keyboard. A total of 96 word pairs and 96 face pairs are shown during a session. One third is neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe always follows the more negative word or face.
~Duration: approx. 10 min. per session. Frequency: Once every day for 2 weeks."
16176919|NCT01570400|Behavioral|Cognitive bias modification training program variant 2|"Computerized, internet-based control training program, variant 2. Participant is exposed to a pair of words or a pair of faces -- either neutral-negative, neutral-positive, or negative-positive -- for 500ms-1000ms, followed by a probe (< or >) in the previous position of ONE of these words or faces and is then asked to press the corresponding arrow button on a keyboard. A total of 96 word pairs and 96 face pairs are shown during a session. One third is neutral-negative, one third is neutral-positive, and one third is negative-positive. The probe follows the more positive stimulus and the more negative stimulus with equal frequency.
~Duration: approx. 10 min. per session. Frequency: Once every day for 2 weeks."
16176920|NCT01570387|Drug|Pomalidomide|Cohort 1 = 2 mg/day, Cohort 2 = 3 mg/day, Cohort 3 = 4 mg/day: Days 1-21 of a 28 day cycle
16176921|NCT01570387|Drug|Dexamethasone|10-20 mg on days 1, 8, 15, and 22
16176922|NCT01570374|Behavioral|Internet-based cognitive behavioral therapy (iCBT)|9 week internet-administered, therapist-assisted, controlled-progression cognitive behavioral therapy (iCBT). Individualized and disorder-specific.
16176923|NCT01570361|Device|Catheter Ablation|Treat subjects with Paroxysmal Atrial Fibrillation (PAF)
16176924|NCT01570361|Drug|Drug Treatment|Drug therapy (either rate or rhythm control): Class I or class III, or AV nodal blocking agents such as beta blockers and calcium channel blockers in accordance with current atrial fibrillation management guidelines.
16176925|NCT01570348|Procedure|Allogeneic Bone Marrow Transplantation|Undergo allogeneic BMT
16176926|NCT01570348|Drug|Cyclophosphamide|Given IV
16176927|NCT01570348|Drug|Fludarabine Phosphate|Given IV
16176928|NCT01570348|Other|Laboratory Biomarker Analysis|Correlative studies
16176929|NCT01570348|Drug|Mycophenolate Mofetil|Given PO
16176930|NCT01570348|Drug|Mycophenolic Acid|Given PO
16176931|NCT01570348|Other|Quality-of-Life Assessment|Ancillary studies
16176932|NCT01570348|Drug|Tacrolimus|Given IV or PO
16176933|NCT01570348|Radiation|Total-Body Irradiation|Undergo TBI
16176934|NCT01570309|Drug|Ergocalciferol|Oral capsule, 50,000 units, once a week, 12 weeks
16176935|NCT01570309|Other|Sugar pill|Oral capsule, once a week, 12 weeks
16176936|NCT01570296|Drug|Gefitinib and BKM120|Dose escalation study of gefitinib and BKM120 with expansion cohort
16176937|NCT01570283|Biological|Multivirus-specific T cells Dose Level 1|"The feasibility and safety of 3 different dose levels will be evaluated and will determine the maximum tolerated dose (MTD) level.
~Dose Level One: 5x10^6 mCTLs/m2
~There may be an option of administering 2 additional doses (at the same level the patient was receiving), 28 days after the first dose, in subjects that have a partial response after one dose or who receive other therapy that may affect the persistence or function of the infused CTL."
16176938|NCT01570283|Biological|Multivirus-specific T cells Dose Level 2|"The feasibility and safety of 3 different dose levels will be evaluated and will determine the maximum tolerated dose (MTD) level.
~Dose Level Two: 1x10^7 mCTLs/m2
~There may be an option of administering 2 additional doses (at the same level the patient was receiving), 28 days after the first dose, in subjects that have a partial response after one dose or who receive other therapy that may affect the persistence or function of the infused CTL"
16176939|NCT01570283|Biological|Multivirus-specific T cells Dose Level 3|"The feasibility and safety of 3 different dose levels will be evaluated and will determine the maximum tolerated dose (MTD) level.
~Dose Level Three: 2x10^7 mCTLs/m2
~There may be an option of administering 2 additional doses (at the same level the patient was receiving), 28 days after the first dose, in subjects that have a partial response after one dose or who receive other therapy that may affect the persistence or function of the infused CTL"
16176940|NCT01570270|Dietary Supplement|CLA enriched cheese|This study was a 3-week, randomized, single blind, controlled, cross over clinical trial, conducted at the State Hospital Brotzu in Cagliari, Italy. The subjects were randomly assigned to eat 90g/d of the control or enriched cheese for 3 weeks, with a cross over after 3 weeks of washout. The study included 5 visits: 2 screening/baseline visits at weeks -1 and 0, 1 end of intake of 90 g/d of cheese visit at week 3, 1 end of the first wash out visit at week 6, and 1 end of treatment after crossing over visit at week 9.
16176941|NCT01570257|Procedure|lowering of the performance level of an adjustable Strata valve in a ventriculoperitoneal (VP) shunt for treating idiopathic normal pressure hydrocephalus|in the intervention group, the performance level(PL) of the valve of the VP shunt, preset at the highest PL (meaning highest resistance) is lowered stepwise in the follow-up period at 1,3 and 9 months postoperatively after implantation until improvement occurs or signs of overdrainage are encountered on a new CT scan of the brain. In the control group the PL is preset and fixed at the second lowest PL and these patients serve as a control group.
16176942|NCT01570244|Drug|levonorgestrel|multiple doses
16176943|NCT01570244|Drug|Ethinylestradiol|multiple doses
16176944|NCT01570244|Drug|levonorgestrel|multiple doses
16176945|NCT01570244|Drug|BI 201335|multiple doses
16176946|NCT01570244|Drug|Ethinylestradiol|multiple doses
16176947|NCT01570231|Device|bilateral limb ischemic preconditioning (Doctormate, IPC-906X)|Device: bilateral limb ischemic preconditioning (Doctormate, IPC-906X, produced by Beijing Renqiao Institute of Neuroscience)five cycles of 5 minutes bilateral upper limb ischemia-reperfusion performed by inflating tourniquets to 200 mmHg, twice daily for 180 consecutive days, along with conventional medical treatment.
16176948|NCT01570218|Behavioral|Music therapy|Music therapy arm: Intervention with 10 sections of music therapy will be performed, twice a week, during 45 days
16176949|NCT01570205|Drug|XG-102|single intravenous infusion
16176950|NCT01570192|Drug|IV meropenem|Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).
16176951|NCT01570192|Drug|I.V. Meropenem|"Subjects assigned to this group will receive IV meropenem (2 g infused over 3 hrs q 8 hr).
~Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage"
16176952|NCT01570192|Drug|Parenteral aminoglycoside; tobramycin for injection USP OR gentamicin sulfate injection solution concentrate 5mg.kg IV q24h; amikacin sulfate injection USP 20 mg/kg IV q24h|a parenteral aminoglycoside (tobramycin or gentamicin-5mg/kg IV Q24h or amikacin 20 mg/kg IV Q24h)
16176953|NCT01570192|Drug|Linezolid or Vancomycin (per institutional guidelines) will be available for MRSA coverage.|Linezolid or vancomycin (per institutional guidelines) will be available for MRSA coverage.
16176954|NCT01570192|Device|tobramycin nebulization|tobramycin nebulization 600mg/day
16176955|NCT01570179|Drug|ideal BW based sugammadex reversal of moderate block|2 mg/kg sugammadex (based og ideal body weight)
16176956|NCT01570179|Drug|real body weight based sugammadex reversal of moderate block|2 mg/kg sugammadex (based on real BW)
16176957|NCT01570179|Drug|real body weight based sugammadex reversal of deep block|4 mg/kg sugammadex (based on real BW)
16176958|NCT01570179|Drug|ideal body weight based sugammadex reversal of deep block|4 mg/kg sugammadex (based on ideal BW)
16177024|NCT01569633|Drug|placebo|The dose of sugar water is 1 ml per 8 hours.
16177068|NCT01569295|Drug|Rituximab|Rituximab 375 mg/m^2 on Day 1, then 500 mg/m^2 every 28 days administered intravenously for a maximum of 6 infusions
16176959|NCT01570166|Procedure|HR|HR was carried out under general anesthesia using a right subcostal incision with a midline extension. Intra-operative ultrasonography was performed routinely to evaluate the tumor burden, liver remnant, and the possibility of a negative resection margin. Anatomic resection, in the form of segmentectomy and/or subsegmentectomy as described by Makuuchi et al. (16) was the preferred surgical method of liver resection. Pringle's maneuver was routinely used with a clamp and unclamp time of 10 min and 5 min, respectively; this technique was used repeatedly throughout the entire procedure.
16176960|NCT01570166|Procedure|RFA|For PRFA, we used a commercially available system with a 375-KHz computer-assisted radiofrequency generator (Elektrotom HiTT 106, Berchtold, Medizinelektronik, Germany) and an open-perfused electrode (Berchtold, Tuttlingen, Germany) of 15 cm (or 20 cm), 14 Ga, and a 15 mm (or 20 mm) active electrode tip with microbores.
16176961|NCT01570140|Behavioral|Web portal|This study investigates the effects of the voluntarily use of a webportal and its educational content.
16176962|NCT01570127|Procedure|Individualized Acupuncture|The treatment was applied twice a week for 20 minutes for 6 weeks(12sessions)
16176963|NCT01570127|Procedure|Standardized Acupuncture|The treatment was applied twice a week for 20 minutes for 6 weeks(12sessions) 8 Acupuncture points, GV4, GV3, BL24(bilateral), BL25(bilateral) and GB30(bilateral) were used for all the patients assigned to this group. Sterile Stainless Steel(25mm x 40mm) disposable acupuncture needles manufactured by Dong-Bang Acupuncture Co.(Korea) were used.
16176964|NCT01570127|Procedure|Sham Acupuncture|The treatment was applied twice a week for 6 weeks(12sessions). The sham acupuncture was applied on the 8 same acupuncture points as in the standardized acupuncture group, GV4, GV3, BL24(bilateral), BL25(bilateral) and GB30(bilateral). Each session was 20 minutes long.
16176965|NCT01570127|Other|Waiting|No interventions were applied to the patients in this group.
16176966|NCT01570114|Device|Fully covered metallic colonic stent|Endoscopically insertion of fully covered metallic colonic stent
16176967|NCT01570101|Device|CE Marked Sapheon Closure System|"CE Marked Sapheon Closure System in closure of incompetent great saphenous veins GSV in a routine clinical setting."
16176968|NCT01570088|Dietary Supplement|Folic acid|One roll/bun per day fortified with 400 µg of folic acid
16176969|NCT01570088|Dietary Supplement|L-5-MTHF|One roll/bun per day fortified with 452 µg of L-5-MTHF
16176970|NCT01570088|Other|Placebo|Placebo contains no folic acids
16176971|NCT01570075|Procedure|HR|SR was carried out under general anesthesia using a right subcostal incision with a midline extension. Intra-operative ultrasonography was performed routinely to evaluate the tumor burden, liver remnant, and the possibility of a negative resection margin. Anatomic resection, in the form of segmentectomy and/or subsegmentectomy as described by Makuuchi et al. (16) was the preferred surgical method of liver resection. Pringle's maneuver was routinely used with a clamp and unclamp time of 10 min and 5 min, respectively; this technique was used repeatedly throughout the entire procedure.
16176972|NCT01570075|Procedure|RFA|For PRFA, we used a commercially available system with a 375-KHz computer-assisted radiofrequency generator (Elektrotom HiTT 106, Berchtold, Medizinelektronik, Germany) and an open-perfused electrode (Berchtold, Tuttlingen, Germany) of 15 cm (or 20 cm), 14 Ga, and a 15 mm (or 20 mm) active electrode tip with microbores.
16176973|NCT01570062|Device|HEPA Filter|"Two HEPA filters will be placed in participant's homes (one in the bedroom and one in the main living area); each HEPA will run for 2 consecutive 7-day sampling sessions. During one of the 7-day sampling sessions, the HEPA filter will run without the internal filter in place (i.e., placebo filtration)."
16176974|NCT01570062|Device|HEPA Filtration Placebo|for one of the two 7-day sampling sessions, both HEPA filters placed in participants' homes will be run without the actual filter in the housing unit.
16176975|NCT01570049|Drug|Bendamustine|for injection
16176976|NCT01570036|Drug|Herceptin|Herceptin will be administered to patients every three weeks as monotherapy for one year, to be given upon completion of standard of care chemotherapy/radiotherapy. The first Herceptin infusion will be given no sooner than three weeks and no later than 12 weeks after completion of chemotherapy/radiotherapy. Herceptin will be dosed at the recommended initial loading dose of 8 mg/kg and at recommended maintenance doses of 6 mg/kg q3wk.
16176977|NCT01570036|Drug|NeuVax vaccine|At the time of vaccine administration, a frozen solution of E75 acetate (1.5mg/ml) is thawed and 1000mcg E75 peptide mixed thoroughly with 250mcg GM-CSF. This constitutes the NeuVax vaccine. For patients randomized to the Herceptin + NeuVax vaccine arm, they will commence Herceptin monotherapy and then will begin the NeuVax vaccine series immediately after completion of the third Herceptin infusion. The vaccine series consists of NeuVax vaccine administered intradermally every three weeks for six total vaccinations, 30-120 minutes after completion of Herceptin infusion.
16176978|NCT01570036|Drug|GM-CSF|For patients randomized to the Herceptin + GM-CSF only arm, they will commence Herceptin monotherapy and then will begin the GM-CSF inoculation series immediately after completion of the third Herceptin infusion. The GM-CSF inoculation series consists of 250mcg GM-CSF administered intradermally every three weeks for six total vaccinations, 30-120 minutes after completion of Herceptin infusion.
16176979|NCT01570023|Behavioral|Isometric Progressive Resistance Oropharyngeal Therapy|Tongue press exercises consist of pressing the tongue against the sensors. Isometric exercises will focus on the anterior and posterior sensor. Subjects will be given a target pressure value for both the anterior and posterior sensor locations for which to aim when doing the exercises. Visual feedback on the display will signal the subject that they have attained their target pressure goal.
16176980|NCT01570010|Other|new norwegian food based dietary guidelines|several means will be applied to guide participarts to cohere to the dietary guidelines including access to clinical nutritionists, free food, food discounts, cooking courses, cookbook/recipies, study website, organized physical activity, etc
16176981|NCT01569997|Other|MultiDisciplinary Team Meetings (MDTM)|The MDTM, between the memory experts and Nursing Home coordinating practitioners, could help the nursing home medical staff identify the cases of dementia and propose these residents an adequate healthcare project (supplementary investigations, therapeutic modifications, hospitalizations...)
16176982|NCT01569984|Radiation|Stereotactic body radiotherapy|Avastin 7.5 mg/kg IV x 2 doses 14 days apart
16177025|NCT01569620|Behavioral|Best clinical practices plus culturally targeted print materials|This intervention arm includes best clinical practices (or usual care at MSSM) and the culturally relevant print materials developed for this study.
16177192|NCT01568411|Drug|TD-1211+ itraconazole|Period 2
16177193|NCT01568398|Drug|TAK-438|
16176983|NCT01569971|Other|Assessment|In this study, through the use of focus groups and questionnaires, we will identify perceptions of transition from pediatric to adult care, transition readiness, disease knowledge, and self-management skills, and assess components of the St. Jude Children's Research Hospital (SJCRH) Sickle Cell Disease Transition Program. Participants will participate in focus groups to discuss transition and transition-related concepts and evaluate components of the transition program. Additionally, participants will complete questionnaires about specific aspects of the transition program and about current disease knowledge and management skills.
16176984|NCT01569958|Other|transcranial direct current stimulation|transcranial direct current stimulation applied to the motor cortex of both sides (1 mA, 20 minutes) for five consecutive days every month for 12 months
16176985|NCT01569958|Other|Sham stimulation|1 mA stimulation for 30 seconds every 900 seconds per session
16176986|NCT01569945|Drug|Clomifen, Ethinyl Estradiol|starting on day 2 or 3 of the cycle: 1 tablet of Clomifen each day, for 5 days in a row. Dose 50mg or in subsequent cycles, 25 mg or 100 mg or 150 mg. After the 5 days of Clomifen, one tablet of Ethinyl Estradiol 50 mg per day, for 5 days in a row or until beta hCG is injected
16176987|NCT01569945|Drug|Menotropins|Starting on day 2 or 3 of the cycle, a daily subcutaneous injection of 37.5 IU or 75.0 IU
16176988|NCT01569919|Biological|TroVax®|Dose of 1 x 10^9 TCID 50/ml, in 1ml, given on day 1 of weeks 1, 3, 6, 9, 12, 15, 18, 21, 24.
16176989|NCT01569919|Drug|Pemetrexed|500 mg/m^2 over 10 mins, given on day 3 of weeks 4, 7, 10, 13.
16176990|NCT01569919|Drug|Cisplatin|75mg/m^2 over 1 hour, given on day 3 of weeks 4, 7, 10, 13
16176991|NCT01569919|Dietary Supplement|Vitamin B12|1000μg intramuscular, Day 2 of weeks 3 and 12
16176992|NCT01569919|Dietary Supplement|Folic Acid|400μg oral daily from Day 2 of week 3 to Day 2 of week 16
16176993|NCT01569919|Drug|Dexamethasone|4mg BD, Days 2-6 of weeks 4, 7, 10, 13
16176994|NCT01569906|Radiation|Narrowband Ultraviolet B phototherapy|Twice weekly exposures for a total of 24 exposures using a standard phototherapy protocol.
16176995|NCT01569893|Other|Self-monitoring for patients with Dibetes mellitus|"Patients are equipped with a telemonitoring kit composed by a portable glucose meter and a gateway device for data transmission.
~The patient can monitor his blood glucose level with a frequency set by the clinician in the personalised treatment plan. Data are transmitted to a regional eHealth centre where a group of operators keeps these information under control and alert the reference clinician in case of worsening of symptoms."
16176996|NCT01569841|Drug|insulin degludec|Administered subcutaneously (s.c., under the skin) once daily.
16176997|NCT01569841|Drug|insulin glargine|Administered subcutaneously (s.c., under the skin) once daily.
16176998|NCT01569828|Drug|LCZ696A|
16176999|NCT01569828|Drug|LCZ696A|once daily administration of 400 mg LCZ696 for 5 days
16177000|NCT01569815|Drug|LCZ696|LCZ696 400 mg once daily
16177001|NCT01569789|Device|Vagus Nerve Stimulator|Voltage 2, placed on cymba concha
16177002|NCT01569789|Device|Vagus Nerve Stimulator|Voltage 2, place on the placebo area of the calf
16177003|NCT01569776|Other|Amino Acid formula|Amino Acid baby formula
16177004|NCT01569776|Other|Commercially available Amino Acid Formula|Hypoallergenic Baby formula
16177005|NCT01569763|Device|Aurora Endometrial Ablation|Endometrial Ablation using the Aurora Endometrial Ablation system
16177006|NCT01569763|Device|Rollerball Ablation/Resection|Hysteroscopic rollerball resection/ablation
16177007|NCT01569750|Drug|Part 1, Cohort 1|Type=exact number, unit=mg, number=280, form=capsule, route=oral use. Escalating doses of ibrutinib (starting on Day 3 for Cycle 1 and on Day 1 for subsequent cycles) administered once daily in with standard-of-care doses of R-CHOP until maximum tolerated dose is achieved.
16177008|NCT01569750|Drug|Part 1, Cohort 2|Type=exact number, unit=mg, number=420, form=capsule, route=oral use. Escalating doses of ibrutinib (starting on Day 3 for Cycle 1 and on Day 1 for subsequent cycles) administered once daily in with standard-of-care doses of R-CHOP until maximum tolerated dose is achieved.
16177009|NCT01569750|Drug|Part 1, Cohort 3|Type=exact number, unit=mg, number=560, form=capsule, route=oral use. Escalating doses of ibrutinib (starting on Day 3 for Cycle 1 and on Day 1 for subsequent cycles) administered once daily in with standard-of-care doses of R-CHOP until maximum tolerated dose is achieved.
16177010|NCT01569750|Drug|Part 2, Cohort 1|Ibrutinib at the recommended Part 1 dose administered once daily with standard-of-care doses of R-CHOP in patients with newly diagnosed diffuse large B-cell lymphoma.
16177011|NCT01569750|Drug|Part 2, Cohort 2|Ibrutinib at the recommended Part 1 dose administered once daily with standard-of-care doses of R-CHOP in patients with newly diagnosed with B-cell non-Hodgkin lymphoma.
16177012|NCT01569737|Drug|ella|ella, single intake, tablet 30mg
16177013|NCT01569724|Other|oral glucose tolerance test (OGTT)|patients presenting an hypertriglyceridemia will have a oral glucose tolerance test (OGTT) in order to diagnose a carbohydrate metabolism disorder
16177014|NCT01569711|Procedure|Deep brain stimulation of nucleus accumbens|"Day0 : surgical placement of electrodes
~M1 : stimulation of nucleus accumbens
~M5 : stimulation of nucleus accumbens or associative territory of caudate nucleus (if no response observed with nucleus accumbens stimulation)"
16177015|NCT01569698|Procedure|acute extra renal replacement therapy|usual modalities of pediatric acute extra renal replacement therapy : Intermittent Hemodialysis, Continuous Renal Replacement Therapies, and Peritoneal Dialysis
16177016|NCT01569685|Drug|Venlafaxine|Tablets, once a day, max 375 mg day (maximal recommended dose)
16177017|NCT01569685|Drug|Sertraline|Tablets, once a day, maximum 200 mg/day (maximum required dose)
16177018|NCT01569672|Behavioral|Patient Navigator matched with subject|Subject is matched with a patient navigator. The patient navigator calls the patient. The amount of time between the abnormal test and treatment will be measured.
16177019|NCT01569672|Behavioral|Subjects are mailed informational/educational materials|Subjects will be mailed informational/educational materials. The amount of time between the abnormal test and treatment will be measured.
16177020|NCT01569659|Drug|Lurasidone|80 mg/day for up to 30 weeks
16177021|NCT01569659|Drug|Lurasidone|Up to 240 mg/day for up to 30 weeks
16177022|NCT01569633|Drug|Metclopramide|Dose of metoclopramide is 0.1miligram per kilogram every eight hours for 7-14 days.
16177023|NCT01569633|Drug|Erythromycin|Dose of erythromycin is 1 miligram per kilogram every eight hours
16177194|NCT01568385|Drug|TAK-438|
16177026|NCT01569620|Behavioral|Best clinical practices plus standard print materials|This intervention arm includes best clinical practices (or usual care at MSSM) and the standard CRC screening print materials developed by the Centers for Disease Control (CDC).
16177027|NCT01569620|Behavioral|Best clinical practices alone|This intervention arm includes best clinical practices (or standard/usual care at MSSM) and no additional print materials.
16177028|NCT01569607|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|Training sessions for 5 days in a row
16177029|NCT01569607|Device|Sham stimulation|Sham stimulation
16177030|NCT01569594|Device|CorMatrix ECM for Carotid Repair|Subjects must be undergoing carotid endarterectomy with patch angioplasty closure
16177031|NCT01569581|Biological|100U/0.5ml in 6-11 months old infants|inactivated EV71 vaccine (KMB-17) of 100U/0.5ml (320Eu/0.5ml) in 1750 infants aged 6-11 months old on day 0, 28
16177032|NCT01569581|Biological|100U/0.5ml in 12-23 months old infants|inactivated EV71 vaccine (KMB-17) of 100U/0.5ml (320Eu/0.5ml) in 1750 infants aged 12-23 months old on day 0, 28
16177033|NCT01569581|Biological|100U/0.5ml in 24-35 months old children|inactivated EV71 vaccine (KMB-17) of 100U/0.5ml (320Eu/0.5ml) in 1500 children aged 24-35 months old on day 0, 28
16177034|NCT01569581|Biological|100U/0.5ml in 36-71 months old children|inactivated EV71 vaccine (KMB-17) of 100U/0.5ml (320Eu/0.5ml) in 1000 children aged 36-71 months old on day 0, 28
16177035|NCT01569568|Other|MRI scanning|1H MRS, DTI, FMRI
16177036|NCT01569568|Behavioral|Cognitive testing|Behavioral testing
16177037|NCT01569529|Behavioral|Online advertisement|Internet advertisement with messages tailored for young adult smoker's motivated to quit
16177038|NCT01569516|Drug|Octohydroaminoacridine Succinate Tablets|1mg, tid
16177039|NCT01569516|Drug|Octohydroaminoacridine Succinate Tablets|1st-2nd week, 1mg, tid 3rd -16th week, 2mg, tid
16177040|NCT01569516|Drug|Octohydroaminoacridine succinate Tablets|1st-2nd week, 1mg, tid, 3rd -4th week, 2mg, tid, 5th-16th week, 4mg, tid
16177041|NCT01569516|Drug|Placebo|0mg, tid
16177042|NCT01569503|Device|vagus nerve stimulation (VNS)|VNS therapy consists of an implanted pacemaker-like device that delivers mild, intermittently pulsed signals to the patient's left vagus nerve. Roughly the size of a small pocket-watch and weighing less than one ounce, the pulse generator is implanted in the patient's left chest area. A thin thread-like wire, attached to the generator, runs under the skin to the left vagus nerve in the neck
16177043|NCT01569490|Behavioral|Incentives for abstinence and treatment engagement|Treatment Incentives - incentives for biochemical verification visits, treatment engagement, and abstinence
16177044|NCT01569490|Behavioral|Attendance incentive|Attendance Incentives - incentives for only attending the biochemical verification visits
16177045|NCT01569477|Behavioral|Incentives for abstinence and treatment engagement|Treatment incentives - incentives for biochemical verification visits, treatment engagement and abstinence
16177046|NCT01569477|Behavioral|Attendance incentive|Attendance Incentives - incentives for only attending the biochemical verification visits
16177047|NCT01569464|Drug|Rotigotine|"Transdermal patch containing Rotigotine formulated in an adhesive matrix. Subjects were to be treated with their optimal dose which consisted of one of the dose strengths below:
~Rotigotine 1 mg /24 hr, Rotigotine 2 mg/ 24 hr, Rotigotine 3 mg/ 24 hr, One patch every 24 hours
~7 weeks (titration plus maintenance)"
16177048|NCT01569464|Other|Placebo|"Placebo patches titrated from 1 mg/ 24 hr - 3 mg/ 24 hr or until effective or maximum dose was reached.
~Placebo 1 mg/ 24 hr, Placebo 2 mg/ 24 hr, Placebo 3 mg/ 24 hr, one patch every 24 hours.
~7 weeks (titration plus maintenance)"
16177049|NCT01569451|Drug|Rituximab|intravenous (IV) infusion of 1000 mg of rituximab on study days 1 (baseline visit) and 15
16177050|NCT01569451|Drug|Glatiramer Acetate|20 mg injected subcutaneously daily
16177051|NCT01569451|Other|Placebo|Subjects will receive an intravenous (IV) infusion of 1000 mg of rituximab or placebo (normal saline) on study days 1 (baseline visit) and 15 according to the rituximab infusion protocol. On study day 28, all subjects will initiate standard GA therapy, 20 mg injected subcutaneously daily.
16177052|NCT01569438|Drug|Gefapixant|50 or 300 mg tablets for a total daily dose of 50, 100, 150, 200, 250 or 300 mg BID, orally with food for 4 weeks
16177053|NCT01569438|Drug|Placebo|Dose matched placebo tablets, BID, orally, with food for 4 weeks
16177054|NCT01569425|Other|Dietary intervention|High Calorie breakfast and high calorie dinner
16177055|NCT01569412|Biological|Ertumaxomab|trifunctional antibody, infusion i.v., increasing doses, up to 10 infusions
16177056|NCT01569399|Other|rTMS (repetitive transcranial magnetic stimulation)|Frequency (10hz) 120% motor threshold 10 sessions
16177057|NCT01569386|Behavioral|Daily low intensity physical activity by the half squat|They take a meal three times daily. They are a time to do the manual work every day. They watch the TV for two hours every day. And they do a walk of 30 minutes every day. They do a specific exercise. They were trained to conduct 40kcal period(about 20 min.) for adding to the amount of energy consumption of low-intensity physical activity at baseline.Specific exercise that was done the half squat(max knee flexion 70 degree). This squat is carried out in two seconds round trip. This squat is carried out in two seconds round trip. They grab the edge of the table. They put half the weight of the lower limbs paralyzed side. This observer once a week, to record their behavior over 24 hours. Intervention period is up to a maximum of 12 weeks.
16177058|NCT01569386|Behavioral|stretch exercise and usual activity|They take a meal three times daily.They are a time to do the manual work every day.They watch the TV for two hours every day.And they do a walk of 30 minutes every day.They do whole body stretch exercise for 20 minute in a day. An observer once a week, to record their behavior over 24 hours.Their behavior was used to calculate the amount of energy consumption.They are informed of the kcal a day from the viewer.
16177059|NCT01569360|Device|Corset|the patients are assigned the use of a custome made corset during daytime
16177060|NCT01569347|Other|Interviews|Interviews
16177061|NCT01569347|Other|Blood sample|Blood sample
16177062|NCT01569347|Other|Hair sample|Hair sample
16177063|NCT01569334|Biological|blood samples|
16177064|NCT01569321|Device|MRI|
16177065|NCT01569321|Device|PET-CT scan|
16177066|NCT01569321|Device|PEM scan with ClearPemSonic|
16177067|NCT01569295|Drug|Idelalisib|Idelalisib 150 mg administered orally twice daily
16177238|NCT01568073|Drug|Benserazide|DOPA decarboxylase inhibitor
16177069|NCT01569295|Drug|Bendamustine|Bendamustine 70 mg/mg^2/day on 2 consecutive days every 28 days administered intravenously for a maximum of 12 infusions
16177070|NCT01569295|Drug|Placebo to match idelalisib|Placebo to match idelalisib administered orally twice daily
16177071|NCT01569282|Procedure|Hepaticojejunostomy and gastroenterostomy|Standard surgical techniques
16177072|NCT01569282|Procedure|Stent strategy|Biliary and/or enteral stents on demand
16177073|NCT01569269|Behavioral|Yoga Intervention|"The yoga intervention will take place for one hour per week for six weeks. All sessions will be guided by a Registered Yoga Teacher (RYT) who is also a Licensed Clinical Social Worker (LCSW).
~Each yoga session will follow a similar protocol. The introductory period (10 minutes) will focus participants on increasing interoceptive and proprioceptive capacity. The main segment is comprised of a series of yoga postures that progress from lying or seated postures that provide gentle muscle stretching to standing stretches that increase balance and flexibility. The postures will be introduced, practiced, and combined with breathing exercises for forty minutes.
~The conclusion of the session will be comprised of 10 minutes of relaxation."
16177074|NCT01569269|Behavioral|Meditation Intervention|The meditation intervention will be conducted weekly for weeks. Each class will follow a similar protocol: During the one-hour meeting, participants will focus on developing attention to the breath. In a supine or seated position and with eyes closed, participants will be guided to attend solely to their breathing. As physical sensations, thoughts, and emotions begin to arise, participants will be taught to recognize, acknowledge, and accept the presence of the sensations or emotions and then to step back, release the thought or sensation, and refocus attention toward the breath At the conclusion of each meeting, the meditation instructor will encourage participants to voluntarily engage in daily meditation practices.
16177075|NCT01569269|Behavioral|Reiki|The Reiki intervention will be conducted for one hour per week for 6 weeks. Protocol for each session: Briefly meet with the Reiki practitioner to review experiences with symptoms of CIPN. Then, the participant will be directed to lie supine and fully clothed on a massage table. Beginning at the top of the head, the practitioner will move inferiorly and pause while holding their hands above, but facing the participant at each energy point until reaching the feet. Upon reaching the participant's feet, the participant will roll from the supine position to a prone position and the process repeated. After being guided to a seated position on the massage table, the practitioner will spend a few moments in conversation with the participation before ending the session.
16177076|NCT01569269|Other|Holistic Education|The psychoeducational intervention will be presented in a traditional classroom format with weekly one hour meetings taking place during the six week study period. Each class meeting will address specific aspects of CIPN. Participants will be presented with content related to basic neuroanatomy, physiology, the effects of chemotherapy on peripheral nervous system, how available allopathic treatments (pharmacological/psychopharmacological) can be helpful, and psychosocial issues related to CIPN. The final week of the psychoeducational group will include the identification of complementary interventions that may be of help to people living with CIPN.
16177077|NCT01569256|Drug|Cabergoline|Cabergoline tablet, Pfizer, Istanbul, Turkey, started on day of HCG, 0.5 mg/day for 8 days
16177078|NCT01569243|Other|Text messages|"Participants will receive diabetic medical care as usual.
~Participants will be given an ActiHealth pedometer to measure daily activity.
~In addition, they will be enrolled to receive the study text messages."
16177079|NCT01569243|Other|Usual care|"Participants will receive diabetic medical care as usual.
~In addition, participants in the control group will be given an ActiHealth pedometer to measure daily activity (step counts will be used as a proxy for activity)."
16177080|NCT01569230|Procedure|Standardized Acupuncture|The treatment was applied twice a week for 20 minutes for 6 weeks(12sessions) 9 Acupuncture points(SP9,GB34, ST36, ST35, Xiyan(EX-LE5), BL60, GB39, SP6 and KI3)were used for all the patients assigned to this group. Sterile Stainless Steel(25mm x 40mm) disposable acupuncture needles manufactured by Dong-Bang Acupuncture Co.(Korea) were used.
16177081|NCT01569230|Procedure|sham acupuncture|The treatment was applied twice a week for 6 weeks(12sessions). The sham acupuncture was applied on the 9 same acupuncture points as in the standardized acupuncture group. Each session was 20 minutes long
16177082|NCT01569230|Procedure|Individualized Acupuncture|The treatment was applied twice a week for 20 minutes for 6 weeks(12sessions)
16177083|NCT01569230|Other|Waiting|No interventions were applied to the patients in this group.
16177084|NCT01569204|Drug|Etoposide|
16177085|NCT01569204|Drug|Cyclophosphamide|
16177086|NCT01569204|Drug|Doxorubicin|
16177087|NCT01569204|Drug|Prednisone|
16177088|NCT01569204|Drug|Procarbazine|
16177089|NCT01569204|Drug|Dexamethasone|
16177090|NCT01569204|Drug|Dacarbazine|
16177091|NCT01569204|Drug|Brentuximab Vedotin|
16177092|NCT01569191|Other|Artificial Tear Supplement|artificial tear supplement (Hypromellose)
16177093|NCT01569191|Device|Cold compress|Cold compress bag fill with temperature retention gel placed over closed eyes Sold by http://www.visiondirect.co.uk/vision-direct/eye-gel-mask-blue
16177094|NCT01569191|Drug|Anti-allergic Medication|1 drop on single occasion after exposure to grass pollen
16177095|NCT01569178|Procedure|Bone Marrow aspiration and intracoronary reinfusion|Bone marrow-derived progenitor cells are obtained from 50ml bone marrow aspirated under local anaesthesia from the iliac crest. Intracoronary infusion of the cells is performed via conventional percutaneous intracoronary intervention techniques using an over-the-wire balloon technique
16177096|NCT01569165|Procedure|cleansing teeth after topical fluoride therapy|washing with water 0, 15 or 30 min after APF treatment or cleansing teeth with cotton roll immediately following APF treatment.
16177097|NCT01569152|Drug|MK-8457 100 mg|MK-8457 100 mg dosed orally BID
16177098|NCT01569152|Drug|Dose-Matched Placebo|Dose-matched placebo dosed orally BID
16177099|NCT01569152|Drug|Methotrexate|MTX dosed at the stable dose receive upon study entry
16177100|NCT01569126|Drug|LY110140|Administered orally as capsules
16177101|NCT01569126|Drug|Placebo|Administered orally as capsules in the placebo arm and to maintain the blind in the 20 mg LY110140 (MD) arm
16177102|NCT01569113|Drug|Ulipristal Acetate (UPA) + ethinylestradiol/levonorgestrel (Microgynon)|UPA: 30 mg, 1 tablet, single intake Microgynon 30mcg/150mcg, 1 tablet per day, 21-day intake
16177103|NCT01569113|Drug|placebo + ethinylestradiol/levonorgestrel|placebo: 1 tablet, single intake Microgynon 30mcg/150mcg, 1 tablet per day, 21-day intake
16177104|NCT01569087|Biological|empegfilrastim|Empegfilgrastim is supplied as solution for injection 3 mg/ml. Empegfilgrastim is to be administered 24 h after the chemotherapy at dose of 3 or 6 mg.
16177105|NCT01569087|Biological|filgrastim|Filgrastim should be administered no earlier than 24 hours after the administration of cytotoxic chemotherapy. Filgrastim should be administered daily for up to 2 weeks until the ANC has reached 10 000/mm3 following the expected chemotherapy-induced neutrophil nadir.
16177106|NCT01569074|Drug|Fostamatinib|Fostamatinib 100mg twice daily for 12 weeks
16177107|NCT01569074|Drug|Fostamatinib|Fostamatinib 100mg twice daily for 4 weeks, followed by150mg once daily up to Week 12
16177108|NCT01569074|Drug|Fostamatinib|Fostamatinib 75mg twice daily for 12 weeks
16177109|NCT01569074|Drug|Fostamatinib|Fostamatinib 50mg twice daily for 12 weeks
16177110|NCT01569074|Drug|Placebo|Placebo twice daily for 12 weeks
16177111|NCT01569061|Device|LCT-1000TM (Manufacturer: LiteCure)|low level laser therapy (LLLT)
16177112|NCT01569061|Device|LCT-1000TM (Manufacturer: LiteCure)|low level laser therapy (LLLT) sham treatment
16177113|NCT01569048|Drug|Propofol and dexmedetomidine|Both group : propofol effect site TCI 2-4 mcg/ml, Remifentanil group : remifentanil effect site-TCI 2-4ng/ml Dexmedetomidine group: dexmedetomidine 0.5mcg/kg loading and 0.5mcg/kg/hr infusion
16177114|NCT01569048|Drug|propofol and remifentanil|Both group : propofol effect site TCI 2-4 mcg/ml, Remifentanil group : remifentanil effect site-TCI 2-4ng/ml Dexmedetomidine group: dexmedetomidine 0.5mcg/kg loading and 0.5mcg/kg/hr infusion
16177115|NCT01569035|Drug|warfarin|3 mg warfarin oral tablet for 2 to 3 weeks
16177116|NCT01569022|Device|CPAP|CPAP Treatment for 12 weeks
16177117|NCT01569022|Device|MAD|MAD Treatment for 12 weeks
16177118|NCT01568996|Drug|broccoli sprout extract - sulforaphane (BSE-SFN)|50 µmol capsules, taken orally, once a day for 28 days
16177119|NCT01568996|Drug|broccoli sprout extract - sulforaphane (BSE-SFN)|100 µmol capsules, taken orally, once a day for 28 days
16177120|NCT01568996|Drug|broccoli sprout extract - sulforaphane (BSE-SFN)|200 µmol capsules, taken orally, once a day for 28 days
16177121|NCT01568983|Dietary Supplement|Placebo|500 ml/day Per 100g 6.25 g sucrose 6.25 g maltodextrin 1.3 g citric acid E330 (pH 3.0) 2.5 g Carmine solution E120 (4% carmine colouring agent) 0.025 g blueberry aroma Potassium sorbate E202 water
16177122|NCT01568983|Dietary Supplement|Mana-juice|500 ml/day of a grape,cherry, bilberry,aronia juice 13g carbohydrates/100g 150mg K/100g
16177123|NCT01568983|Dietary Supplement|Optijuice|500 ml/day of a Grape,cherry, bilberry,aronia, black current juice 13g carbohydrates/100g 150mg K/100g
16177124|NCT01568970|Behavioral|Return-to-work Rehabilitation + Follow up|3 1/2 weeks of Return-to-work rehabilitation followed by 6 months of Return-to-work follow-up
16177125|NCT01568970|Behavioral|Return-to-work rehabilitation|3 1/2 weeks of Return-to-work rehabilitation followed by standard follow-up
16177126|NCT01568957|Behavioral|Gait training|Twelve 30-minute sessions plus 10-minute stretching and warm up, provided 3 times per weeks for 4 weeks. Up to 6 weeks are allowed to complete the 12 sessions.
16177127|NCT01568944|Drug|Oral Antibiotic and Oral Rinse|PO Amoxicillin in 500 mg / Metronidazole 250 mg of each TID for 8 days plus 2 ounces of 0.12% chlorhexidine mouthrinse used BID
16177128|NCT01568944|Procedure|Standard Treatment|Full mouth scaling and root planing using hand instrumentation (curettes) and ultrasonic scalers
16177129|NCT01568931|Drug|Urokinase|intracoronary, urokinase, 200,000 Units, bolus
16177130|NCT01568931|Drug|Saline|intracoronary, saline, bolus 1 cc
16177131|NCT01568918|Drug|Tamsulosin hydrochloride|Participants will receive 0.4 mg/day tamsulosin hydrochloride from 5 days prior to the operation until hospital discharge.
16177132|NCT01568918|Other|Placebo|The placebo capsule matching the active study drug will be given daily from 5 days prior to the operation until hospital discharge.
16177133|NCT01568905|Other|Low level nicotine cigarette|smoke the study cigarette exclusively for one week
16177134|NCT01568905|Other|Intermediate nicotine level cigarette|smoke the study cigarette exclusively for one week
16177135|NCT01568905|Other|High level nicotine cigarette|smoke the study cigarette exclusively for one week
16177136|NCT01568892|Drug|Dolutegravir 50 mg twice daily|Active dolutegravir plus failing background regimen (Day 1 to Day 7). Open label dolutegravir plus optimized background regimen (from Day 8)
16177137|NCT01568892|Drug|Dolutegravir placebo twice daily|Dolutegravir placebo plus failing background regimen (Day 1 to Day 7)
16177138|NCT01568879|Other|Control|The control group will receive care from their primary care physician that reflects the actual current care received by KPNC patients, but will not receive any treatment recommendations from the study protocol. The control subject will have regular monitoring of serum uric acid levels and will be provided with educational material and dietary counseling.
16177139|NCT01568879|Other|Gout Disease Management Program|The experimental group will utilize standard guidelines for the initiation of uric acid lowering treatments, and approved medications. The study protocol treatments include medication management, dietary guidelines, and basic educational materials on gout and its management. No non-formulary medications or devices will be used. The experimental procedure to be tested is the use of a structured protocol to manage and monitor standard treatments.
16177140|NCT01568866|Drug|Carfilzomib|Carfilzomib is administered over 30 minutes as an infusion.
16177141|NCT01568866|Drug|Bortezomib|Bortezomib is administered as a 3-5 second bolus IV injection or SC injection (in accordance with regulatory approval)
16177142|NCT01568866|Drug|Dexamethasone|Tablet for oral administration; On days when carfilzomib or bortezomib was administered, the dexamethasone was to be given 30 minutes to 4 hours prior to the carfilzomib or bortezomib dose.
16177143|NCT01568853|Drug|Norepinephrine|Intravenously, 10 ug/min, 24 hours
16177144|NCT01568853|Procedure|Open abdomen|IAH >=20 mmHg, and ACS emerged, such as low urine and decreased FiO2 quickly.
16177145|NCT01568853|Other|enteral nutrition|500-1500 kcal/day; Nasogastric tube feeding;
16177146|NCT01568853|Other|parenteral nutrition|3000 mL parenteral nutrition fluid, intravenously.
16177147|NCT01568840|Other|Global Postural Reeducation Group|Sessions happened once a week for 10 weeks, lasting 60 minutes each and consisted in manual therapy maneuvers and global postural reeducation treatment.
16177148|NCT01568840|Other|Segmental Exercises Group|Sessions happened once a week for 10 weeks, lasting 60 minutes each and consisted in segmental exercises (stretching and strengthening) treatment.
16177149|NCT01568827|Dietary Supplement|Blackraspberry Slurry|Blackraspberry slurry is 45 g blackraspberry powder mixed in 8oz. water. This is equivalent to 450 g fresh black raspberries.
16177150|NCT01568814|Drug|Low volume PEG|low volume polyethylene glycol 2 liter one time
16177151|NCT01568814|Drug|high volume PEG|high volume polyethylene glycol 4 lilter split-dosing 2L/2L two times
16177152|NCT01568801|Behavioral|SingaPACE|Individuals in the intervention group will go through an integrated program of community based health and social care, based on intake and ongoing evaluation by the SingaPACE team.
16177153|NCT01568788|Biological|Inactivated Influenza Vaccine|200 subjects were randomly assigned (60 children, 100 adults and 40 elders) to receive Inactivated Influenza Vaccine (Split virion) of Hualan Biologicals, 15ug HA/strain/0.5ml/syringe, one dose regime
16177154|NCT01568788|Biological|Inactivated Influenza Vaccine of Pasteur|200 subjects (60 children, 100 adults and 40 elders) were randomly assigned to receive the Inactivated Influenza Vaccine of Sanofi Pasteur, 15ug HA/strain/0.5 ml/syringe, one dose regime,
16177155|NCT01568788|Biological|Inactivated Influenza Vaccine of GSK|200 subjects (60 children, 100 adults and 40 elders) were randomly assigned to receive Inactivated Influenza Vaccine (Split virion) of GSK, 15ug HA/strain/0.5ml/syringe, one dose regime
16177156|NCT01568775|Drug|Aliskiren|All patient and subjects received single dose of aliskiren 300 mg in treatment period.
16177157|NCT01568762|Drug|VAK694|Intravenous infusion
16177158|NCT01568762|Drug|VAK694 placebo|Intravenous infusion
16177159|NCT01568762|Drug|QAX576|Intravenous infusion
16177160|NCT01568762|Drug|QAX576 placebo|Intravenous infusion
16177161|NCT01568749|Drug|Paracetamol|Paracetamol
16177162|NCT01568749|Drug|Paracetamol formulation 1|Paracetamol
16177163|NCT01568749|Drug|Paracetamol Formulation 2|Paracetamol
16177164|NCT01568749|Drug|Paracetamol formulation 3|Paracetamol
16177165|NCT01568749|Drug|Paracetamol formulation 4|paracetamol
16177167|NCT01568684|Other|Citalopram|Treatment
16177168|NCT01568645|Drug|Carvedilol|
16177169|NCT01568645|Drug|Imatinib|
16177170|NCT01568632|Drug|Imetelstat|
16177171|NCT01568606|Device|Body Composition Analysis InBody Scale|"Patients will have their ICD interrogated using a pacemaker Programmer specifically designed from one of the 4 pacemaker manufacturers: St. Jude, Medtronic, Guidant, and Biotronik. Depending on the type of pacemaker, interrogation can be done either wirelessly or by placing a wand over the pacemaker. The ICD will be turned to a monitor-only mode to disable risk of ICD shock by the supervising electrophysiologist. Patient will be asked to step on the InBody 520 scale to have their body composition analyzed. Patient will continue to have their ICD actively monitored. Analysis will take approximately 30 - 50 seconds. At the end of analysis, ICD device will be returned to default settings by supervising electrophysiologist."
16177172|NCT01568593|Device|T2750|1 drop in each eye 3 to 6 times daily during 84 days
16177173|NCT01568593|Device|Vismed|1 drop in each eye 3 to 6 times daily during 84 days
16177174|NCT01568580|Drug|GreenGene|Dose : 10 ~ 50IU/kg Administration method : intravenous infusion or bolus
16177175|NCT01568567|Dietary Supplement|Lactobacillus Reuteri DSM 17938|One stick pack in the morning and one stick pack afternoon/evening for 28 days.
16177176|NCT01568541|Drug|Regular toothpastes|One tooth brushing
16177177|NCT01568541|Drug|Children's toothpastes|One tooth brushing
16177178|NCT01568528|Drug|Oxytocin|OT intervention will be administration of OT intranasally at a dose of three 4 IU puffs per nostril for a total dose of 24 IU. This dose has been used in a number of other similarly designed challenge studies examining the effects of a single dose of OT (Kirsch et al. 2005; Kosfeld et al. 2005; Guastella et al. 2008a; Guastella et al. 2008b; Rimmele et al. 2009; Andari et al. 2010).
16177179|NCT01568528|Drug|Placebo|The PBO/control will consist of the OT vehicle only delivered as 3 puffs of saline per nostril for a total of 6 puffs. Each puff contains 0.1 ml in volume, so the total delivered will be 0.6 ml intranasally.
16177180|NCT01568528|Other|Control|Participants who have no psychiatric diagnosis and will be controls for this project. These controls will NOT receive oxytocin or PBO. They will only receive psychiatric screening interview, MCCB Consensus Cogntive Battery assessment, urine drug screen, vision testing, and the three social cognition tasks.
16177181|NCT01568515|Procedure|Electronic Message|Students enrolled in the intervention group received 7 electronic contacts over a 7-month period. Specifically, participants received 4 electronic education messages, 2 electronic reminder/education messages, as well as 1 baseline and 1 final assessment contacts. Up to 4 reminder contacts were used if surveys were not completed for both intervention and control group participants. Control group participants will receive 2 contacts throughout the study, 1 at baseline and 1 at their final assessment. Up to 4 reminder contacts were used if surveys were not completed. Intervention & control groups were compared longitudinally for 7 months on the differences in HPV vaccine utilization and adherence, knowledge and attitudes about HPV, and the HPV vaccine (parallel design).
16177182|NCT01568489|Drug|HL-009 Liposomal Gel|a semi-transparent red-color gel and is supplied as a laminated tube
16177183|NCT01568476|Procedure|Distal|Blockade of both terminal branches of Sciatic nerve separately, distal to bifurcation
16177184|NCT01568476|Procedure|Interneural|Sciatic nerve blockade at the site of bifurcation
16177185|NCT01568450|Drug|Oxycodone|Oxycodone XL 20mg(20mg once a day, fasted)
16177186|NCT01568450|Drug|Oxycodone|Oxycodone XL 20mg/day(20mg once a day, after high fat meal)
16177187|NCT01568450|Drug|Oxycodone|Oxycodone 20mg/day (10mg twice a day, fasted)
16177188|NCT01568437|Procedure|TAP-Block|Block needle will be inserted out-of-plane to the ultrasound beam, perpendicular to the skin surface, until the tip lies deep between the fascia of the transversus abdominis muscle and the internal oblique muscle. 30 ml of the study solution in each side will be injected at this location and should be observed to spread in an anterior-posterior direction between two muscles. Each patient will receive a total dose of 60 ml of 0.25% bupivacaine (150 mg) + 1:200,000 epinephrine.
16177189|NCT01568437|Other|Conventional Managment|For these group.no TAP block administration. just conventional management for post operative pain.
16177190|NCT01568424|Device|CentriMag RVAS placement|Patients will be treated with a CentriMag RVAS
16177191|NCT01568411|Drug|TD-1211|Period 1
16177195|NCT01568372|Other|Telephone follow-up|The intervention group received a telephone follow-up by a nurse on the 1st, 3rd, 5th and 10th postoperative day.
16177196|NCT01568346|Other|MRI|Breast MRI
16177197|NCT01568333|Drug|Decitabine|Decitabine 3.5mg/m2，ivdrip，qd x 3d, every four weeks for one cycle. It will be given three cycles.
16177198|NCT01568320|Device|Endovascular Treatment (Zenith)|Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.
16177199|NCT01568307|Drug|Participants will be prescribed an approved selective serotonin re-uptake inhibitor (SSRI) antidepressant.|The choice of SSRI will be based on clinical judgement and prescribed in line with standard dosing approved by the Therapeutic Goods Administration (TGA).
16177200|NCT01568294|Drug|pomalidomide|2 mg or 4mg oral pomalidomide once per day on Days 1-21 of a 28-day cycle
16177201|NCT01568281|Drug|Anastrozole ODF|Each volunteer will receive a single dose of Anastrozole ODF with water.
16177202|NCT01568281|Drug|Arimidex tablet|Each volunteer will receive a single dose of Arimidex tablet with water
16177203|NCT01568281|Drug|Anastrozole ODF|Each volunteer will receive a single dose of Anastrozole ODF without water.
16177204|NCT01568281|Drug|Arimidex tablet|Each volunteer will receive a single dose of Arimidex tablet with water
16177205|NCT01568268|Drug|Palonosetron|palonosetron 0.075 mg intravenous injection over 10 seconds when nausea with NRS >= 4, or developement of retching or vomiting more than one time within three hour after the end of surgery.
16177206|NCT01568268|Drug|placebo control group|placebo intravenous injection over 10 seconds when nausea with NRS >= 4, or developement of retching or vomiting more than one time within three hour after the end of surgery.
16177207|NCT01568255|Drug|Ergocalciferol|Ergocalciferol therapy at 50,000IU for 8 weeks
16177208|NCT01568255|Drug|Placebo|placebo at 50,000IU for 8 weeks
16177209|NCT01568242|Device|Phacoemlsification|Transurgical measurement of temperature
16177210|NCT01568229|Drug|AMG 747|Three dose levels once-daily oral administration
16177211|NCT01568229|Drug|Placebo|Once-daily oral administration
16177212|NCT01568216|Drug|AMG 747|Three dose levels once-daily oral administration
16177213|NCT01568216|Drug|Placebo|Once-daily oral administration
16177214|NCT01568203|Drug|AMG 579|3 dose levels of single oral dose administration of AMG 579 in healthy subjects (Part A), and 5 dose levels of single oral dose administration of AMG 579 in patients with schizophrenia or schizoaffective disorder (Part B)
16177215|NCT01568203|Drug|Placebo|Matching placebo control for AMG 579 at each dose level
16177216|NCT01568190|Biological|AVANZ MITE|Immunotherapy Dermatophagoides mix
16177217|NCT01568177|Behavioral|Mental Stress Testing|Mental stress testing is used to test the mechanistic pathways through which biobehavioral variables are involved in the pathogenesis of MCD in women.
16177218|NCT01568177|Other|Peripheral Arterial Tonometry (PAT) Testing|PAT measurements will be used to predict ischemia in patients with MCD. PAT will be measured by Endo PAT 2000 (Itamar® Medical Ltd).
16177219|NCT01568177|Other|Heart Rate Variability (HRV)|Holter monitor will be used to measure heart rate and rhythm for approximately 24 hours.
16177220|NCT01568177|Other|RESPeRATE Breathing Trial|RESPeRATE Breathing will test whether a controlled breathing relaxation technique using an FDA-approved paced breathing device, RESPeRATE, helps with chest pain and shortness of breath and will test to see if this form of biofeedback or relaxation technique helps with heart rate variability during mental stress.
16177221|NCT01568177|Procedure|SPECT cardiac scan with 123I-mIBG and Myoview|Single Photon Emission Computed Tomography (SPECT) cardiac scan with 123I-mIBG and Myoview will be used to measure cardiac sympathetic activity.
16177222|NCT01568164|Device|PliCath HF System|This study is a multi-center, prospective, single-armed, study designed to evaluate the safety and efficacy of the BioVentrix PliCath HF System for left ventricular volume restoration in patients with ischemic cardiomyopathy.
16177223|NCT01568151|Behavioral|Clinic-directed intervention program|Clinic-directed intervention program: Subjects recruited at the Intervention Clinics will first be provided with Clinic-directed interventions including: 1)provider-directed interventions (computerized case-based education, evidence-based guidelines, ask the expert; 2)office-based systems (risk assessment forms, procedure monitoring, follow-up protocol, audit with feedback, chart reminders); and 3) waiting room materials.
16177224|NCT01568151|Behavioral|Individual Patient-Directed Program|If the subjects have not undergone colorectal cancer screening within 12 months of receiving the clinic-directed program, they will be provided with an individual patient-directed program consisting of the following stepped interventions: 1) tailored physician letter, easy-to-read educational materials, and an fecal occult blood test (FOBT)information sheet and card; 2) telephone counseling for those who do not respond to the letter; and 3) home visits by lay health advisors for those who do not respond to the letter or phone counseling.
16177225|NCT01568138|Device|PliCath HF System|To evaluate the safety and feasibility of the BioVentrix PliCath HF Epicardial Catheter-based Ventricular Reduction (ECVR) System for left ventricular (LV) volume reduction in heart failure (HF). The System utilizes anchors that are implanted into the scarred portion of the heart, rendering the ventricle smaller.
16177226|NCT01568125|Drug|Incretin-related drugs|DPP-IV inhibitors are administered via per os. GLP-L receptor agonists are administered via subcutaneous injections.
16177227|NCT01568112|Drug|BG00012 (dimethyl fumarate)|Each capsule contains 120 mg dimethyl fumarate (DMF). Fast titration involves taking one 120 mg capsule in the morning and one in the evening (240 mg daily) for one week, and then escalating to a dose of 480 mg daily (two capsules morning and evening) for the remainder of the study.Slow titration expands the dose escalation time to 4 weeks.
16177228|NCT01568112|Drug|BG00012 placebo|Placebo matching BG00012
16177229|NCT01568112|Drug|ASA|325 mg microcoated aspirin (ASA)
16177230|NCT01568112|Drug|ASA placebo|Placebo matching aspirin
16177231|NCT01568099|Biological|AFFITOPE® PD01A|s.c. injection
16177232|NCT01568099|Other|Control|Untreated control
16177233|NCT01568073|Drug|BIA 9-1067|5, 25 and 50 mg of BIA 9-1067 (once-daily)
16177234|NCT01568073|Drug|Entacapone|200 mg entacapone (concomitantly with each L-dopa/DDCI dose)
16177235|NCT01568073|Drug|Placebo|200 mg
16177236|NCT01568073|Drug|Levodopa|
16177237|NCT01568073|Drug|Carbidopa|DOPA decarboxylase inhibitor
16177239|NCT01568060|Other|Infanrix-IPV data collection|Safety monitoring: recording of adverse events using diary cards and recording of serious adverse events using the latest version of Korea's Post-Marketing Surveillance Serious Adverse Event Reporting Form.
16177240|NCT01568047|Drug|Placebo|once-daily
16177241|NCT01568047|Drug|BIA 9-1067|BIA 9-1067 - 5 mg single-dose
16177242|NCT01568047|Drug|BIA 9-1067|BIA 9-1067 - 15 mg single-dose
16177243|NCT01568047|Drug|BIA 9-1067|BIA 9-1067 - 30 mg single-dose
16177244|NCT01568047|Drug|Levodopa/Carbidopa|Levodopa 100 mg Carbidopa 25 mg
16177245|NCT01568047|Drug|Levodopa/Benzerazide|Levodopa 100 mg Benzerazide 25 mg
16177246|NCT01568034|Drug|BIA 9-1067|BIA 9-1067 - 25 mg single-dose
16177247|NCT01568034|Drug|BIA 9-1067|BIA 9-1067 - 50 mg single-dose
16177248|NCT01568034|Drug|BIA 9-1067|BIA 9-1067 - 100 mg single-dose
16177249|NCT01568034|Drug|Placebo|single-dose
16177250|NCT01568034|Drug|Levodopa/Carbidopa|Levodopa 100 mg Carbidopa 25 mg
16177251|NCT01568034|Drug|Levodopa/Benzerazide|Levodopa 100 mg Benzerazide 25 mg
16177252|NCT01568021|Other|No Intervention|No intervention was administered in this study.
16177253|NCT01568008|Drug|Bimatoprost 0.01% ophthalmic solution|Bimatoprost 0.01% ophthalmic solution eye drops at a dose and frequency as determined by the physician.
16177254|NCT01567995|Drug|Clobetasone Butyrate 0.05% Cream|Clobetasone Butyrate 0.05% Cream
16177255|NCT01567995|Drug|Vehicle (base cream)|Vehicle (base cream)
16177256|NCT01567982|Device|tDCS, prefrontal cortex and parietal cortex|tDCS is a non invasive brain stimulation methods. We will use two anodes to stimulate prefrontal and/or parietal cortex using 2mA current for 20 minutes.
16177257|NCT01567969|Behavioral|Intensive In-home Child and Adolescent Psychiatric Service|A six to seven month intensive intervention provided by a clinical team consisting of a master's-level clinician and a bachelor's-level mental health counselor delivering comprehensive psychiatric and case management services in the child's home. One or both members of the team works with the child and the family three times a week in the home. Delivery of direct and indirect services average 5.5 hours of service per week.
16177258|NCT01567969|Behavioral|Home-based Child Treatment Coordination|A six to seven month home-based case management service delivered by a master's level clinician. The coordinator meets with the child's parent/legal guardian in the child's home once a month and conducts weekly phone conversations to facilitate referral and access to appropriate mental health services for the child.
16177259|NCT01567956|Drug|Propionyl-L-Carnitine|500 mg modified release tablets, 500 mg bid; treatment duration 8 weeks
16177260|NCT01567956|Drug|Placebo|500 mg inert substances modified release tablets, 500 mg bid; treatment duration 8 weeks
16177261|NCT01567943|Behavioral|Contingency Management|Behavioral reinforcement for alcohol abstinence
16177262|NCT01567930|Drug|Temsirolimus|Intervention: Temsirolimus IV Eligible patients will receive temsirolimus IV on days 1,8,15 every 21 days. Treatment will continue till disease progression or untolerable side effects
16177263|NCT01567917|Procedure|CRC surgery|"Patients will receive surgery for the treatment of CRC as routine clinical practice. These patients will be prospectively observed for the development of VTE(Group A; Doppler US cohort vs. Group B; Simple observation cohort)
~- Doppler US is not an intervention. The Doppler US is a non-invasive test (ultrasonography) for the detection of VTE"
16177264|NCT01567904|Drug|Semuloparin sodium|"Solution for injection in single dose vials (10 mg/mL and 20 mg/mL)
~Subcutaneous injection"
16177265|NCT01567891|Biological|NYESO-1c259 T cells|Cytoreductive chemotherapy followed by infusion with NYESO-1(C259) transduced autologous T cells. Patients will receive at least 1x10⁹ transduced cells, however the target dose for this protocol is for patients to receive 5x10⁹ transduced cells with a maximum possible dose of 6x10⁹ administered as a single intravenous (IV) infusion.
16177266|NCT01567865|Biological|Vaccine produced in existing facility|Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the existing facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
16177267|NCT01567865|Biological|Vaccine produced in new facility|Live attenuated Japanese encephalitis vaccine SA 14-14-2 (LJEVac) produced in the new facility by the Chengdu Institute of Biological Products (CDIBP), Chengdu, China
16177268|NCT01567852|Drug|Ketamine|Ketamine (1.5mg/kg) will be given for induction, with room to titrate up to induction effect
16177269|NCT01567852|Drug|Methohexital|Methohexital (1.5mg/kg) will be given for induction
16177270|NCT01567839|Procedure|Mandibular buccal Infiltration injection|
16177271|NCT01567826|Drug|standard of care lipid therapy|"Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
~Zocor, Lipitor [any dose] and Crestor [less than 40mg]"
16177272|NCT01567826|Drug|Aggressive lipid therapy|Patients will be randomized in a 1:1 fashion to receive either A) Rosuvastatin (Crestor) 40mg daily, or B) standard-care lipid-lowering therapy.
16177273|NCT01567800|Other|18F-Fluoroazomycin Arabinoside (18F-FAZA)|PET scan with the radiolabelled tracer 18F-FAZA
16177274|NCT01567787|Radiation|Proton Radiation for MPNST|30 CGE at 6 CGE/Fx
16177275|NCT01567787|Radiation|Proton Radiation for neurofibromas|25 CGE at 5 CGE/Fx
16177276|NCT01567774|Drug|Atorvastatin|os, 20 mg, once per day, for 30 days
16177277|NCT01567774|Drug|Rosuvastatin|os, 10 mg, once per day, for 30 days
16177278|NCT01567748|Procedure|BP Measurements at aorta, radial and femoral locations|The following additional research related procedures will be performed in patients recruited into the study: 1) a small cuff will be placed on one the finger of each subject to measure the pulse in the finger (Finapres); 2) a cannula will be placed in the femoral artery by the surgeon to measure femoral artery pressure; 3) for a period of two minutes immediately before and after the cardiopulmonary bypass a small cannula (the size of a pencil tip) will be inserted by the surgeon under direct vision into the aorta and 4) the information from each of these cannula will be recorded on a computer for later study.
16177279|NCT01567735|Drug|TMC435|Type=exact number, unit=mg, number=150, form=capsule, route=oral use. TMC435 capsule is taken once daily for 12 weeks.
16177280|NCT01567722|Genetic|DNA analysis|This sample will be used for germline DNA analysis.
16177281|NCT01567722|Genetic|RNA analysis|RNA will be sheared, reverse transcribed, and sequenced to assess transcribed sequences.
16177810|NCT01563614|Drug|Lomustine|Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.
16177282|NCT01567722|Genetic|gene expression analysis|Genomic analyses performed on these samples may include, but are not limited to, array-based gene expression profiling, comparative genome hybridization, and single nucleotide polymorphism studies, as well as whole genome sequencing analysis using the most current genomic technology available.
16177283|NCT01567722|Genetic|polymorphism analysis|Genomic analyses performed on these samples may include, but are not limited to, array-based gene expression profiling, comparative genome hybridization, and single nucleotide polymorphism studies, as well as whole genome sequencing analysis using the most current genomic technology available.
16177284|NCT01567722|Other|biologic sample preservation procedure|Genomic analyses performed on these samples may include, but are not limited to, array-based gene expression profiling, comparative genome hybridization, and single nucleotide polymorphism studies, as well as whole genome sequencing analysis using the most current genomic technology available.
16177285|NCT01567722|Other|flow cytometry|Information will include HIV RNA load at time of malignancy diagnosis) and imaging tests, results of the diagnostic tumor biopsy and bone marrow biopsy, and results of flow cytometry, cytogenetics, and molecular studies.
16177286|NCT01567722|Other|medical chart review|Participants will be followed prospectively to record the types of treatment given, and treatment outcome and toxicity.
16177287|NCT01567709|Drug|Alisertib|Given PO
16177288|NCT01567709|Other|Laboratory Biomarker Analysis|Correlative studies
16177289|NCT01567709|Other|Pharmacological Study|Correlative studies
16177290|NCT01567709|Drug|Vorinostat|Given PO
16177291|NCT01567683|Drug|Imiquimod (topical use)|
16177292|NCT01567670|Drug|Naloxone|2 mg x 1-2
16177293|NCT01567670|Drug|naloxone placebo|h2o placebo spray
16177294|NCT01567657|Drug|pethidin hydrochlorid, midazolam|Pethidin hydrochlorid: 25 mg iv. at the beginning of the examination Midazolam: 1-2 mg iv. at the beginning of the examination. Repetitive given in a dosis of 1 mg iv. until a total amount of 7 mg iv.
16177295|NCT01567657|Drug|Propofol|"50 years and over: initial dose of 50-60 mg Propofol iv. Followed by bolus of 20-30 mg iv. until sedation is achieved.
~< 50 years: initial dose 30-40 mg Propofol iv. Followed by bolus of 10-20 mg until sedation is achieved."
16177296|NCT01567644|Device|Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)|Energy Density - 0.09 mJ/mm2
16177297|NCT01567631|Procedure|intrahepatic Glisson's approach|Forty patients with liver disease were selected and divided into intrahepatic Glission's group as described in the detailed description.Total laparoscopic hepatectomy with intrahepatic Glisson's approach were performed. Operation began with division of liver ligaments, liver mobilization, followed by intrahepatic access to the Glissonian pedicle (containing arterial, portal, and bile duct branches ). A endoscopic stapler devices was used for Glissonian pedicle cutting and suture. Liver parenchyma was divided by harmonic scalpel combined with vascular stapler. The specimen was extracted through suprapubic incision.
16177298|NCT01567631|Procedure|classical hepatectomy|Forty patients with liver disease were selected and divided into classical laparoscopic hepatectomy group as described in the detailed description.Total laparoscopic anatomical hepatectomy with classical procedure were performed.The initial step is to dissect hepatic portal and expose the liver artery, portal Vein branch and the bile duct. Then endoscopic stapler devices were used to cut the canal mentioned above. Final step is to divide the liver parenchyma along the following ischemic delineation.
16177299|NCT01567618|Drug|Docetaxel|"Docetaxel 50mg/m2 iv drip, repeat every two weeks;
~Efficacy will be evaluated every three cycles."
16177300|NCT01567618|Drug|Fluorouracil|Fluorouracil 400mg/m2 iv D1; Fluorouracil 2400mg/m2 civ 46 hours; repeat fortnightly and evaluate every two cycles
16177301|NCT01567605|Drug|Lidocaine lubricant|Subjects using this intervention will receive 30 mL of Lidocaine hydrochloride jelly (2%)
16177302|NCT01567605|Other|Placebo lubricant|Subjects using this intervention will receive 30 mL of placebo lubricant (no topical anesthetic)
16177303|NCT01567592|Device|Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)|Energy Density - 0.09 mJ/mm2
16177304|NCT01567566|Other|exercise rehabilitation program|6 week home based exercise rehabilitation program with 6 weekly supervised sessions using real time ultrasound as biofeedback to augment training in both treatment arms
16177305|NCT01567553|Other|USPIO MRI - Gadolinium MRI|"USPIO MRI scanning will be performed at :
~baseline, month 3, month 6, month 9 and month 12 for patients recruited prior to the 1st of May 2010.
~baseline, month3, month 6 and month 9 for patients recruited between the 1st of May 2010 and the 31st of July 2010,
~baseline, month 3 and month 6 for patients recruited between the 1st of August 2010 and the 31st of October 2010,
~baseline and month 3 for patients recruited between the 1st of November 2010 and the 31st of January 2011,
~baseline for patients recruited between the 1st of February 2011 and the 30rd of April 2011.
~Gadolinium MRI scanning will be performed at baseline, month 3, month 6, month 9, month 12, month 18, month 24 and month 36."
16177306|NCT01567540|Drug|Sitagliptin|100 mg Sitagliptin daily for 15 weeks
16177307|NCT01567527|Drug|Intramuscular (IM) Depot Aripiprazole|Formulation: Intramuscular (IM) Depot Aripiprazole Formulation 400 mg or 300 mg, once a month injection
16177308|NCT01567527|Drug|Intramuscular (IM) Depot Placebo|Formulation: Intramuscular (IM) Depot Placebo 400 mg or 300 mg, once a month injection
16177309|NCT01567514|Procedure|Glass ionomer cement lining|Resin-modified glass ionomer lining
16177310|NCT01567501|Drug|Levocetirizine Dihydrochloride tablets 5 mg|5 mg tablet once in a day
16177311|NCT01567501|Drug|Levocetirizine Dihydrochloride|5 mg tablet once in a day
16177312|NCT01567488|Drug|Everolimus|Everolimus 10mg/day
16177313|NCT01567488|Drug|octreotide LAR|30 mg each 28 days
16177314|NCT01567475|Drug|Everolimus and rituximab|One injection of Rituximab 375 mg/m2 per week during 28 days followed by one Rituximab infusion every other cycle at 375 mg/m2 associated with everolimus at 5mg or 10 mg every day or 5 mg every other day.
16177315|NCT01567462|Device|Monopolar electrocautery loop in Transurethral resection of bladder tumors|Standard monopolar electrocautery loop in transurethral resection of bladder tumors (TURBT)
16177316|NCT01567462|Device|PK Button Vaporization Electrode in transurethral resection of bladder tumors|PlasmaKinetic (PK) Button Vaporization Electrode in transurethral resection of bladder tumors (TURBT)
16177347|NCT01567215|Procedure|alcohol|Alcohol swabs 82% ethanol. Application 6 - 8 times a day, each time the parents change the diaper. Treatment for 3 weeks or less if the granuloma disappears.
16177317|NCT01567436|Device|Shang Ring|The Shang Ring is a sterile device consisting of two concentric medical grade plastic rings: an inner ring with a silicone band and an outer, hinged ring. The inner ring fits inside the outer ring which will lock when snapped together. The Shang Ring comes in multiple sizes. The appropriate size is determined through use of a measuring strip. To ensure that men cannot remove the device prematurely, the locking mechanism must be broken open using a tool that is similar to a scalpel handle. Then, a pair of scissors is used to remove the inner ring, and a bandage or gauze dressing is applied.
16177318|NCT01567423|Drug|ASAQ Winthrop® Sanofi Aventis|Artesunate 25mg / amodiaquine 67.5mg: 1 tab/day for 3 days in children 5 to 8.9 kg Artesunate 50mg / amodiaquine 135mg: 1 tab/day for 3 days in children 9 to 17.9 kg
16177319|NCT01567423|Drug|Coartem®, Novartis|"artemether 20 mg / lumefantrine 120 mg co-formulated tablets given as six twice-daily doses over three days:
~tab/dose for children 5 to 14.9 kg (total 6 tabs)
~tabs/dose for children 15 to 24.9 kg (total 12 tabs)"
16177320|NCT01567410|Other|e-learning|Braden scale and pressure ulcer classification
16177321|NCT01567410|Other|traditional classroom training|Braden scale and pressure ulcer classification
16177322|NCT01567384|Drug|OSI-906 and Pemetrexed|"Pemetrexed will be administered intravenously on day 1 of cycle 1 at a dose of 500 mg/m2 as a 10-minute infusion. Subsequent doses will be defined by tolerability.
~OSI-906 will be administered orally twice daily (12 hours apart) at approximately the same times each day on a continuous schedule, beginning on Day 0 of cycle 1."
16177323|NCT01567371|Device|LiDCO rapid monitor|Technology which provides a continuous means of monitoring various hemodynamic parameters including cardiac output and pulse pressure variability.
16177324|NCT01567358|Biological|Infliximab|100mg/vial
16177325|NCT01567358|Biological|Infliximab|100mg/vial
16177326|NCT01567345|Device|Implantable pump with continuous flow|Insertion of an implantable pump filled up with the analgesic solution. Connection of the catheter to the intrathecal space. Continuous morphine's flow is scheduled.
16177327|NCT01567345|Device|Implantable pump with programmable flow.|Insertion of an implantable pump filled up with the analgesic solution. Connection of the catheter to the intrathecal space. Programmable morphine's flow is scheduled.
16177328|NCT01567332|Device|SHAM - MagproR30 - DGM-512 - 9016E0741 - Tonika elektronics A/S - Active coil|"For each patient, stimulation inactive (sham) and 1 Hz stimulation activates the healthy motor cortex (randomization). Active or sham session: Each session includes a series of 5 sessions of 20 'weekly (daily for 5 d) evaluation and pre-rTMS (T0 within 6 h before the procedure) and 1h post-rTMS (T1), at J8 (T2) and J21 (T3).
~6-week interval between two sessions."
16177329|NCT01567332|Device|SHAM inactive - MagproR30 - DGM-512 - 9016E0741 - Tonika elektronics A/S - Inactive coil|"For each patient, stimulation inactive (sham) and 1 Hz stimulation activates the healthy motor cortex (randomization). Active or sham session: Each session includes a series of 5 sessions of 20 'weekly (daily for 5 d) evaluation and pre-rTMS (T0 within 6 h before the procedure) and 1h post-rTMS (T1), at J8 (T2) and J21 (T3).
~6-week interval between two sessions."
16177330|NCT01567319|Biological|Skin Prick Test|Skin prick test of 4 concentrations of each allergenic source, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm. Assessment of the wheal size after 15 minutes.
16177331|NCT01567319|Biological|Skin Prick Test - Atopic Subjects|Skin prick test of 4 concentrations of each allergenic source,together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm. Assessment of the wheal size after 15 minutes.
16177332|NCT01567319|Biological|Skin Prick Test - No Atopic Subjects|Skin prick test of 4 concentrations of each allergenic source, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every subjects in duplicate on the volar surface of the forearm. Assessment of the wheal size after 15 minutes.
16177333|NCT01567306|Biological|Allergovac Depot|Increasing dosages till the maintenance dose of 0.25 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
16177334|NCT01567306|Biological|Allergovac Depot|Increasing dosages till the maintenance dose of 0.5 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
16177335|NCT01567306|Biological|Allergovac Depot|Increasing dosages till the maintenance dose of 1SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
16177336|NCT01567306|Biological|Allergovac Depot|Increasing dosages till the maintenance dose of 2 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
16177337|NCT01567306|Biological|Allergovac Depot|Increasing dosages till the maintenance dose of 4SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
16177338|NCT01567306|Biological|Placebo|Increasing volumes of placebo. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
16177339|NCT01567267|Behavioral|Experimental educational intervention|Educational intervention consisting of a 4-day-course in Evidence-based Medicine and Good Scientific Practice combined with the method of Problem-based Learning.
16177340|NCT01567267|Behavioral|Standard educational intervention|Educational intervention on the didactics of biology (4-day-course) not containing elements of Evidence-based Medicine, Good Scientific Practice or Problem-based learning.
16177341|NCT01567254|Behavioral|guided imaginary|Auditory guided imagery disk - will be prepared by Ronit Brooks, a clinical psychologist, who is engaged in guided imagery and by Livia Yanai, an art therapist.
16177342|NCT01567254|Behavioral|music ONLY|music. It will be equal in length to the auditory guided imagery disk
16177343|NCT01567241|Other|clinical hypnosis or relaxation music|25 minute tape recording
16177344|NCT01567228|Other|CHICA GIS (enhanced electronic medical record)|An electronic medical record enhanced with geographic information systems will assist physicians in directing patients to community resources for increasing physical activity, preventing dental caries or addressing school problems
16177345|NCT01567215|Procedure|silver nitrate|Application 1 - 2 times a week for 3 - 4 weeks
16177346|NCT01567215|Drug|Steroids|Dermovate creme group IV steroid. Application 2 times a day for 3 weeks or less if the granuloma disappears.
16177890|NCT01563016|Dietary Supplement|glucose drink|participants will receive a drink rich in glucose
16177348|NCT01567202|Procedure|Surgery|Maximum resection of the tumor (≥95%) with the help of conventional or intraoperative MRI neuronavigation. Confirmation will be proceeded by the contrast MRI within 72 hours after surgery.
16177349|NCT01567202|Drug|Chemotherapy|Temozolomide(TMZ), 200mg·m^-2·d ×5 days，28 days every cycle. 6 cycles of TMZ are recommended.
16177350|NCT01567202|Radiation|Radiotherapy|Standard dose, 4500 cGy to tumor with 3-cm margins, 1500 cGy boost to tumor bed.
16177351|NCT01567202|Biological|DC vaccination|Eight to ten million dendritic cells (DCs) - administered via intradermal injections in 0.5 ml Phosphate Buffered Saline (PBS) in the shoulders near the back of the neck to facilitate trafficking of the DCs to the cervical lymph nodes.
16177352|NCT01567202|Drug|blank placebo|Saline that has the same appearance with DC vaccine.
16177353|NCT01567189|Behavioral|Cardiac rehabilitation|"Training sessions: 8 weeks of supervised physical training sessions. Stress intensity will be calculated from the peak heart rate reached during stress test: 60-70% during the first month and 70-85% during the second one. Patients will be advised to do at least 1 hour of outdoor exercise with the same intensity on the days when they do not attend hospital.
~Health education sessions and relaxation sessions: one per week.
~Smoking and diet checking: as recommended by doctor."
16177354|NCT01567189|Behavioral|Cardiac rehabilitation|The only difference in the hospital's program is that training sessions will be out of hospital with the same target heart rate that in this case will be controlled with pulsometer or Borg scale. The recommended frequency of sessions will be: at least 5 days a week with a minimum of 1 hour / day.
16177355|NCT01567176|Biological|Blood sample|It is a single cross sectional study. All outcome measures will be taken during the investigation with physical examination, questionnaire and a blood sample
16177356|NCT01567163|Biological|Ramucirumab|ramucirumab 10 milligrams/kilogram (mg/kg) intravenous infusion, administered on Day 1 of 3-week cycle
16177357|NCT01567163|Drug|Docetaxel|docetaxel 75 milligrams/square meter (mg/m^2) intravenous infusion administered on Day 1 of each 3-week cycle
16177358|NCT01567150|Device|Novel Dressing|Topical wound dressing
16177359|NCT01567124|Drug|Moxonidine|"Participants who are randomly assigned to the moxonidine/experimental group will be treated with moxonidine oral tablets for twelve weeks. Participants will begin their moxonidine treatment at 0.2mg dosage, which will be increased to 0.4mg over the first two weeks.
~At the end of the twelve weeks of treatment, participants will be withdrawn from moxonidine over a period of two weeks."
16177360|NCT01567124|Drug|Placebo|"To examine the effects of moxonidine treatment, a placebo oral tablet will be used for comparison purposes.
~The duration and number of placebo tablets participants will be required to take will be the same as the amount required in the moxonidine group."
16177361|NCT01567124|Drug|Moxonidine|"Participants who are randomly assigned to the moxonidine/experimental group will be treated with moxonidine oral tablets for twelve weeks. Participants will begin their moxonidine treatment at 0.2mg dosage, which will be increased to 0.4mg over the first two weeks.
~At the end of the twelve weeks of treatment, participants will be withdrawn from moxonidine over a period of two weeks."
16177362|NCT01567124|Drug|Placebo|"To examine the effects of moxonidine treatment, a placebo oral tablet will be used for comparison purposes.
~The duration and number of placebo tablets participants will be required to take will be the same as the amount required in the moxonidine group."
16177363|NCT01567111|Procedure|11C-Metomidate Positron Emission Tomography|Dose of intravenous 11C-Metomidate injection is 440MBq and emission scanning of upper abdomen. PET/CT imaging will be done using the Discovery PET/CT VCT or 690 scanner (General Electric Medical Systems, Milwaukee, WI, USA)
16177364|NCT01567098|Procedure|single incision laparoscopic appendectomy|performing appendectomy through a single incision in the abdomen
16177365|NCT01567085|Drug|Eculizumab|
16177366|NCT01567072|Drug|Ibuprofen|Treatment with Ibuprofen 600mg 3times a day in 7 days after Colles fracture diagnosis
16177367|NCT01567072|Drug|Ibuprofen|Treatment with Ibuprofen 600mg 3 times daily in 3 days after´diagnosis - Colles fracture
16177368|NCT01567072|Drug|Placebo|Only placebo treatment instead of NSAID painkillers
16177369|NCT01567059|Drug|tosedostat|Given PO
16177370|NCT01567059|Drug|cytarabine|Given IV
16177371|NCT01567059|Drug|decitabine|Given IV
16177372|NCT01567046|Other|laboratory biomarker analysis|Correlative studies
16177373|NCT01567033|Behavioral|PAT Curriculum + Health Information|Participants in the intervention group will receive the standard PAT curriculum plus information about healthy eating and an active lifestyle. This curriculum will be taught during up to 36 home visits in two years. Months 1-3 the visits are weekly; months 4-6 visits are biweekly; months 7-24 visits are monthly
16177374|NCT01567020|Other|Diagnostic|All participants will be evaluated with a battery of behavioral and electrophysiological measures to assess central auditory processing abilities.
16177375|NCT01567007|Behavioral|individual counseling|Consisting of three sessions within a maximum period of 3 months. We conducted a counseling, aimed at increasing physical activity, aiming to raise at least 2000 steps over the first week of monitoring. Furthermore, we discuss the importance of physical activity, such as overcoming barriers to physical activity and targets agreed between the parties. The pedometer is given along with a diary to record the number of steps and returned in the last session.
16177376|NCT01567007|Behavioral|group counseling|The counseling was conducted in groups (10-12 individuals) for 6 sessions at weekly intervals, and two sessions with fortnightly. Each session lasts 60 minutes. The advice is aimed at behavioral changes using the following approaches: advantages and disadvantages of behavior change, how to overcome barriers to physical activity, self-monitoring of physical activity by using the pedometer and setting goals (number of steps / day) in the short term and what to do in case of relapse (not accomplish what was represented) besides livings practices. As the GII and the goal is to raise at least 2000 steps daily on average, with the main focus physical activity in leisure time and transport
16177377|NCT01567007|Behavioral|aerobic training|The fitness program is held two times per week with individuals and groups with three sessions lasts for 40 minutes performed on a treadmill.
16177378|NCT01566994|Behavioral|TTM Tailored|This treatment is tailored on three occasions (baseline, 6, and 24 weeks) on each of the 14 TTM variables. This treatment provides both normative and ipsative feedback on each of the variables found to predict progress across specific stages
16177667|NCT01564784|Drug|inotuzumab ozogamicin|Dose: inotuzumab ozogamicin 0.8-0.5 mg/m^2 IV, weekly, 3 times per cycle Cycle length: 21-28 days Total number of cycles: 6
16177379|NCT01566994|Behavioral|Motivational Enhancement Therapy|This intervention will be driven by the manual developed by Carpenter et al. (2004) based on the USPHS recommendations for smokers not motivated to quit and for those who become ready to set a quit date.
16177380|NCT01566994|Behavioral|Integrated Treatment|This enhanced condition would combine MET, Reduction Counseling and NRT and TTM Tailoring.
16177381|NCT01566981|Procedure|Computerised support to the Diabetes type II patients|The randomly selected group of patients with diabetes type II will get software application and web based support to their usual healthcare process.
16177382|NCT01566968|Other|Cough challenge test|Cough challenge will be performed with Capsaicin, citric acid and prostaglandin E2.
16177383|NCT01566968|Other|24 hour ambulatory cough recording|Cough recording by using an ambulatory sound recording device.
16177384|NCT01566968|Other|Cough quality of life questionnaire|questionnaire designed to assess impact of cough on a person's life
16177385|NCT01566955|Procedure|transgastric adnexectomy|adnexectomy transgastrically with transvaginal support
16177386|NCT01566942|Drug|Oxaliplatin|In this arm, patients will receive the adjuvant chemotherapy with mFOLFOX6 regimen for 8 cycles. Oxaliplatin 85mg/m2, day1, every 2 weeks; Leucovorin 200mg/m2,day1,every 2 weeks;5-FU 400mg/m2,iv, day1, 5-FU 3.0g/m2, bolus for 46h,every 2 weeks
16177387|NCT01566942|Drug|Irinotecan|In this arm, patients will receive the adjuvant chemotherapy with FOLFIRI regimen for 8 cycles. Irinotecan 180mg/m2, day1, every 2 weeks; Leucovorin 200mg/m2,day1,every 2 weeks;5-FU 400mg/m2,iv, day1, 5-FU 3.0g/m2, bolus for 46h,every 2 weeks
16177388|NCT01566929|Dietary Supplement|Low calorie diet treatment|Reduction of calorie intake to only 800 kcal/day by using LCD during 12 weeks
16177389|NCT01566916|Procedure|Total Hip Arthroplasty|
16177390|NCT01566890|Drug|regadenoson infusion with contrast-enhanced ultrasound|Subjects who are not having a pain crisis receive a 24-hour infusion of regadenoson. Contrast-enhanced ultrasound will be performed four times during the 24 hour regadenoson infusion
16177391|NCT01566890|Procedure|contrast-enhanced ultrasound|Subjects who are not having a pain crisis will have contrast-enhanced ultrasound performed up to four times over a two-day period. Time points will resemble the time course used for the Regadenoson Arm, although no investigational drug will be given.
16177392|NCT01566890|Procedure|contrast-enhanced ultrasound|Contrast-enhanced ultrasound will be performed on adults with sickle cell anemia at baseline who are not having a pain crisis and performed again during a pain crisis
16177393|NCT01566890|Procedure|contrast-enhanced ultrasound|Contrast-enhanced ultrasound will be performed on healthy control subjects at baseline, on the first day of the study and 30 days later
16177394|NCT01566890|Procedure|contrast-enhanced ultrasound|Contrast-enhanced ultrasound will be performed on healthy volunteers (Technique Optimization Controls)
16177395|NCT01566877|Drug|AVI-7288|"Cohort 1: AVI-7288 at 1 mg/kg IV; Cohort 2: AVI-7288 at 4 mg/kg IV;Cohort 3: AVI-7288 at 8 mg/kg IV; Cohort 4: AVI-7288 at 12 mg/kg IV
~The amount of AVI-7288 required to administer the required dose will be diluted to a volume of approximately 150 mL with normal saline solution (NSS) and given by IV infusion over 30 minutes once a day for 14 days. Infusions will be administered at approximately the same time each day."
16177396|NCT01566877|Other|Placebo|Normal Saline Solution (NSS)
16177397|NCT01566864|Behavioral|Improve clinic based measurement of blood pressure|This intervention seeks to improve BP control and reduce disparities through an organizational change and new skills development. To improve the reliability of BP measurement in clinics, new automated BP machines (Omron HEM-907XL) will be provided for each PCP. Medical assistants will be trained and certified in the proper use of the Omron machine by a master trainer. The will be trained to measure the arm circumference, choose the appropriate cuff and place it properly on the arm. They will be recertified yearly. Once activated, the Omron HEM-907XL will lead measurement for 5 minutes then perform a series of 3 BP measurements spaced by 30 seconds and present the man of these 3 measurements. The mean will be record in the electronic medical records.
16177398|NCT01566864|Behavioral|Provider education system to promote patient-centered care|The provider education intervention will address blood pressure control and disparities through audit and feedback. The intervention includes a hypertension dashboard and a linked provider-tailored education intervention. The latter aims to enhance provider communication skills during clinical encounters with hypertension patients, via teaching specific verbal behaviors with practice implications related to elicitation of hypertension treatment and adherence concerns. The dashboard is a web based tool linked to the electronic medical records that imports clinic measurements of BP and offers PCPs a quick assessment of the percentage of those achieving blood pressure control and receiving guideline-concordant care in their panel, clinic, and system overall and by patient race/ethnicity.
16177399|NCT01566864|Behavioral|Introduce care management system in clinics|The care management (CM) intervention will address blood pressure management and disparities through patient education, promotion of self-management, and the introduction of an organizational change through the addition of new team members. The CM team will contact patients with a BP of ≥140/≥90 (≥130/≥80 for patients with diabetes mellitus or chronic kidney disease) as identified through the electronic medical records for enrollment in care management services. Patients with a BP in these ranges will be referred to a CM program that emphasizes four key self-management behaviors: diet, physical activity, medication adherence, and self-monitoring. The self-management promotion program will consist of 3 one-on-one sessions either with a Pharm D. or R.D. over the course of 3 months.
16177400|NCT01566851|Other|Cardiovascular check-up|Cardiovascular check-up once a year in patients with rheumatoid arthritis
16177401|NCT01566838|Drug|Subpleural pain catheter with infusion of 0.125% bupivacaine|Patients in this arm will be provided with a subpleural pain catheter and instructions for removal when pump is empty (around 5 days time). The catheter will contain an infusion of 0.125% bupivacaine. The single lumen pain catheter is infused by a self deflating pump filled to 335ml, which delivers the infusate at a rate of 4ml/h. Pumps are expected to be empty in 4 to 5 days.
16177431|NCT01566643|Drug|RA5-RACM7|rabeprazole 20mg bid + amoxicillin 1g bid treated for 5 days, then rabeprazole 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid + metronidazole 0.5g bid for other 7 days
16177432|NCT01566643|Drug|RA3-RACM7|rabeprazole 20mg bid + amoxicillin 1g bid treated for 3 days, then rabeprazole 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid + metronidazole 0.5g bid for other 7 days
16177668|NCT01564784|Drug|FLAG (fludarabine, cytarabine and G-CSF)|Dose: cytarabine 2.0 g/m^2/day IV days 1-6 fludarabine30 mg/m^2/day IV days 2-6 Cycle length: 28 days Total number of cycles: 4
16177402|NCT01566838|Drug|Standard acute pain management|"A standard balanced anesthetic consisting of midazolam 0.01-0.03mg/kg, induced with propofol (1-2mg/kg) or etomidate, fentanyl (1-2 mcg/kg) and rocuronium (0.1mg/kg) and a potent inhalation agent (sevoflurane 1.5%-2.5%) during procedures.
~Prior to emergence from anesthesia, patients will receive ketorolac 30mg IV, neuromuscular reversal agents, and ondansetron 4mg. Fentanyl will be given, as needed, to facilitate patient comfort and extubation.
~The ASA guidelines for acute pain management in the perioperative period will be followed. Patients shall receive 1,000 mg of acetaminophen orally every 6 hours, scheduled for 5 days. Other drugs will be given on as needed basis (PRN) to maintain an analog pain scale of ≤ 3."
16177403|NCT01566825|Drug|Amitriptyline|amitriptyline 25 mg at 9:30 pm, day 10, and 50 mg at 1:30 am, day 11
16177404|NCT01566825|Drug|Placebo|placebo(white 8 mm Lichtenstein®) at 9:30 pm, day 10, and at 1:30 am, day 11
16177405|NCT01566812|Behavioral|Breast feeding optimization|Breast feeding optimization program extends from late pregnancy period to 6 months after birth. Prenatal intervention consists of individual and group counseling/education; perinatal intervention consists of in-hospital lactation support; postnatal intervention consists of home visit, counseling session, reminding telephone call and bulk SMS, special counseling for working mothers, breast pump rental, occupational-related support
16177406|NCT01566812|Behavioral|Usual care|Usual care applied in the hospital
16177407|NCT01566799|Drug|Metformin|metformin 500 mg/day po for 24 weeks.
16177408|NCT01566786|Drug|activated recombinant human factor VII|Starting dose of trial drug 10 mcg/kg, escalating up to five dose tiers: 20 mcg/kg, 40 mcg/kg, 80 mcg/kg, 120 mcg/kg and 160 mcg/kg. Administered within the first 4 hours after the insult
16177409|NCT01566786|Drug|placebo|Starting dose of trial drug 10 mcg/kg, escalating up to five dose tiers: 20 mcg/kg, 40 mcg/kg, 80 mcg/kg, 120 mcg/kg and 160 mcg/kg. Administered within the first 4 hours after the insult
16177410|NCT01566773|Drug|PT001 MDI|Administered as two puffs BID for 14 days
16177411|NCT01566773|Drug|Tiotropium Bromide|Taken as 1 capsule containing 18 µg of tiotropium via the Handihaler DPI
16177412|NCT01566773|Drug|PT001 Placebo MDI|
16177413|NCT01566760|Drug|fesoterodine fumarate|One capsule of 4 mg PF-00695838 Formulation SR1 under fasting conditions, single dose
16177414|NCT01566760|Drug|fesoterodine fumarate|One capsule of 4 mg PF-00695838 Formulation SR2 under fasting conditions, single dose
16177415|NCT01566760|Drug|fesoterodine fumarate|One capsule of 4 mg PF-00695838 Formulation SR1 under fed conditions, single dose
16177416|NCT01566760|Drug|fesoterodine fumarate|One capsule of 4 mg PF-00695838 Formulation SR2 under fed conditions, single dose
16177417|NCT01566760|Drug|fesoterodine fumarate|one extended-release tablet of commercially available fesoterodine fumarate 4 mg under fasting conditions, single dose
16177418|NCT01566747|Drug|Pazopanib|Pazopanib 800mg day to be given continuously until disease progression.
16177419|NCT01566734|Other|Cefazolin irrigation|after the surgery and before closing up the patients, 2 grams of cefazolin in 5 cc of distilled water was used to irrigate the patients
16177420|NCT01566734|Other|Normal Saline Irrigation|after the surgery and before closing up the patients, 150 cc of normal saline was used to irrigate the patients and in the last group
16177421|NCT01566721|Drug|Herceptin|Herceptin will be given as 600 mg SC (into thigh) on Day 1 of each 3-week cycle for up to 18 cycles.
16177422|NCT01566708|Behavioral|Neuro-Music Therapy immediately|20 patients are randomized to receive Neuro-Music Therapy immediately. Neuro-Music Therapy takes 5 days and comprises 9 consecutive 50-minutes sessions of individual therapy. Immediately before and after treatment extensive diagnostics are performed, including psychological assessment, functional neuroimaging and electro-physiological examinations.
16177423|NCT01566708|Behavioral|Neuro-Music Therapy after waiting time|20 Patients were randomized to receive Neuro-Music Therapy after a waiting period not exceeding 6 weeks. Within this waiting time, patients undergo exactly the same diagnostic procedure as the patients of the treatment group.
16177424|NCT01566708|Behavioral|Music-therapeutical stress management coaching|20 non-tinnitus controls matched in age, gender and hearing ability receive a music-therapeutical stress coaching program. This intervention is based on the main treatment components of the Neuro-Music Therapy for acute tinnitus with alterations of the tinnitus specific elements. Immediately before and after this five-day coaching, controls undergo exactly the same diagnostic procedure as the patients of the treatment group.
16177425|NCT01566695|Drug|Oral Azacitidine|300 mg daily, days 1 to 21 of each 28-day treatment cycle
16177426|NCT01566695|Drug|Placebo|Identically matching placebo tablets on day 1 to 21 of each 28-day treatment cycle.
16177427|NCT01566695|Other|Best Supportiv Care (BSC)|BSC included and was not limited to packed RBC (packed red blood cell [pRBC] and whole blood), platelet transfusions (single donor or pooled donor), antibiotic, antiviral and/or antifungal therapy, nutritional support, and granulocyte colony stimulating factors (G-CSF) for participants who experienced neutropenic fever/infections.
16177428|NCT01566669|Drug|Parecoxib Sodium|Before incision, patients in Group P (n = 120) receive 40mg of parecoxib IV. Thereafter, parecoxib patients receive 40mg of parecoxib IV every 12 h for 48 h. 30 min before the end of surgery, a mixture of 6 mL of ropivacaine 0.25% and 2mg morphine was given epidurally. Epidural patient-controlled analgesia was initiated by using ropivacaine 0.125% (1.25 mg/ml) and morphine 0.005% (0.05 mg/ml) with a basal infusion rate of 2 ml/h, a demand dose of 2 ml, and a 15-min lockout.
16177429|NCT01566669|Drug|Normal saline|Before incision, patients in Group C (n = 120) receive 2 mL of normal saline IV. Thereafter, they receive 2 mL of normal saline IV every 12 h for 48 h. 30 min before the end of surgery, a mixture of 6 mL of ropivacaine 0.25% and 2mg morphine was given epidurally. Epidural patient-controlled analgesia was initiated by using ropivacaine 0.125% (1.25 mg/ml) and morphine 0.005% (0.05 mg/ml) with a basal infusion rate of 2 ml/h, a demand dose of 2 ml, and a 15-min lockout.
16177430|NCT01566656|Drug|total lymphoid irradiation and anti-thymocyte globulin|"TLI Administration: TLI is administered ten times in 120 cGy fractions on day -11 through day -7 and day -4 through day -1.
~ATG: Thymoglobulin will be administered five times intravenously at 1.5 mg/kg/day from day -11 through day -7 for a total dose of 7.5 mg/kg.
~Mobilized PBSCs (Day 0): The desired cell doses (based on recipient body weight) for MRD and MUD transplants are around 4-8 x106 CD34+ cells/kg.
~GVHD Prophylaxis: Cyclosporine A (CSP) 3 mg/kg IV from day-3 and Mycophenylate mofetil (MMF) 500 mg x 4/ day PO from day 0"
16177669|NCT01564784|Drug|HIDAC (high dose cytarabine)|cytarabine 3 g/m^2 IV every 12 hours for up to 12 times
16177433|NCT01566643|Drug|RA7-RACM7|rabeprazole 20mg bid + amoxicillin 1g bid treated for 7 days, then rabeprazole 20mg bid + amoxicillin 1g bid + clarithromycin 0.5g bid + metronidazole 0.5g bid for other 7 days
16177434|NCT01566630|Drug|Placebo|Placebo to RLX030 as intravenous infusion for 72 hours
16177435|NCT01566630|Drug|RLX030|RLX030 1 mg/mL vials
16177436|NCT01566617|Other|Standard care and Pharmaceutical care|Pharmaceutical care is the direct interaction between the pharmacist and the drug's users in order to improve the therapeutic compliance among outpatients and promote adequate pharmacotherapeutic follow-up.
16177437|NCT01566617|Other|Standard care|These patients will only receive standard care, with out follow-up by the pharmacist
16177438|NCT01566604|Drug|NVA237|Delivered via a single dose dry powder inhaler
16177439|NCT01566604|Drug|Placebo|Delivered via a single dose dry powder inhaler
16177440|NCT01566591|Device|Deep TMS Treatment|24 TMS treatments over 6 weeks .
16177441|NCT01566591|Device|Sham Treatment|24 TMS treatments over 6 weeks
16177442|NCT01566578|Drug|Human recombinant epidermal growth factor|topical
16177443|NCT01566578|Other|Placebo cream|Dermal cream without EGF
16177444|NCT01566565|Drug|Theophylline and Bambuterol|Treatment 3: Theophylline, 300 mg plus Bambuterol, 20 mg
16177445|NCT01566552|Drug|AMBISOME|SINGLE DOSE AMBISOME FOR TREATMENT OF VISCERAL LEISHMANIASIS
16177446|NCT01566539|Drug|Intranasal Oxytocin (OT) 24 IU|Participants will self-administer a single dose of 24 international units (IU) oxytocin. Five puffs per nostril, each with 2.4 IU oxytocin. Ten puffs total.
16177447|NCT01566539|Drug|Intranasal Vasopressin (AVP)|Participants will self-administer a 1 ml solution containing 20 units of AVP. Five puffs per nostril, each with 2 International Units (IU) AVP. Ten puffs total).
16177448|NCT01566539|Drug|Intranasal Placebo|Participants will receive placebo sprays that are pH adjusted to comparable levels of the drugs given. Five puffs per nostril; ten puffs total.
16177449|NCT01566539|Drug|Intranasal Vasopressin (AVP) 40 IU|Participants will self-administer a 0.5 ml solution containing 40 international units (IU) of AVP. 5 puffs in total, each with 4 International Units (IU) AVP.
16177450|NCT01566539|Drug|Lorazepam|Subjects will take 1.0 mg of lorazepam orally 60 minutes prior to fMRI scan.
16177451|NCT01566526|Drug|dexamethasone intravitreal implant 0.7 mg|OZURDEX® administered at least twice in accordance with routine clinical practice as part of the Belgium Medical Needs Program.
16177452|NCT01566513|Behavioral|Community Connector|The participant randomized into this arm of the study is invited to work with a person trained as a community connector, someone who is trained in Intentional Peer Support but does not have a lived experience of mental illness.
16177453|NCT01566513|Behavioral|Peer Recovery Mentor|A participant randomized into this arm of the study is offered the chance to work with a Peer Recovery Mentor, who is trained in Intentional Peer Support.
16177454|NCT01566513|Behavioral|Peer Case Manager|A participant randomized into this arm of the study is offered the chance to work with a Peer Recovery Mentor, who is trained in Intentional Peer Support.
16177455|NCT01566487|Drug|Quetiapine fumarate|Quetiapine fumarate tablets 300mg
16177456|NCT01566474|Drug|Omeprazole|Omeprazole 40 mg/day alone. Patients will take the capsule once in the morning before breakfast. This is the standard therapy for patients suffering from Barrett's esophagus.
16177457|NCT01566474|Drug|Melatonin|Omeprazole 40 mg/day + Circadin 6 mg/12 hours. Patients will take the Omeprazole capsule once in the morning before breakfast together with 3 tables of 2 mgs of Circadin (melatonin). In the evening, before dinner, patients will take 3 tablets of 2 mg of Circadin.
16177458|NCT01566461|Device|Drug-Coated Balloon (DCB)|Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
16177459|NCT01566461|Device|PTA Balloon: Balloon Angioplasty|Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon (DCB) Arm or to the standard angioplasty balloon Arm
16177460|NCT01566448|Drug|Ketamine|20mg/5ml swish and spit four times daily
16177461|NCT01566435|Drug|paclitaxel albumin-stabilized nanoparticle formulation|
16177462|NCT01566435|Drug|Cisplatin|
16177463|NCT01566435|Drug|Fluorouracil|
16177464|NCT01566435|Radiation|Intensity modulated radiation therapy|
16177465|NCT01566435|Drug|Cetuximab|
16177466|NCT01566435|Procedure|Quality-of-life assessment|ACF baseline, IMRT baseline, Day 7, Week 12, months 6 and 12
16177467|NCT01566422|Drug|Vancomycin powder|patients randomized to this group will receive vancomycin powder in the surgical incision after posterior spinal fusion.
16177468|NCT01566409|Drug|Polyethylene glycol 3350|Powder for solution. Each sachet contains 13.125 g of macrogol 3350. Disimpaction dosage consists of 1,5 g/kg, maintenance treatment are adjusted according til the Bristol stool chart. The drug can be taken at anytime of the day and can also be divided. Treatment duration up to ½ year.
16177469|NCT01566409|Other|Placebo|Placebo will be manufactured and packaged as a powder to make it identical to the bags with the PEG 3350. The powder will comprise of a non-active substance, like a mild rehydration solution, which is a composition consisting of salt and sugar.
16177470|NCT01566396|Device|A3F|A3F fractional RF treatments for facial wrinkles
16177471|NCT01566383|Procedure|24-hr pH monitoring|"Visit 1
~The following will be done:
~A medical history including review of your current drugs;
~Collection of demographic information;
~A manometry, before the 24-hour pH testing, to find the junction between the esophagus and stomach;
~24-hour pH testing will be done
~Visit 2
~You will return to the clinic 24 hours after the visit 1 and the following will occur:
~The catheter will be removed from your nose; and
~You will return the recording device"
16177472|NCT01566370|Drug|Zonisamide|titration of dose to 500mg oral, daily, over 8 weeks, then 6 weeks of treatment at that dose
16177473|NCT01566370|Drug|Placebo|placebo
16177474|NCT01566357|Other|Toothpaste|
16177475|NCT01566357|Dietary Supplement|Milk|
16177476|NCT01566357|Dietary Supplement|Fluoridated Milk|
16177477|NCT01566357|Drug|Tooth Mousse|
16177478|NCT01566357|Drug|MI Paste Plus|
16177479|NCT01566357|Drug|Elmex Erosion Protection|
16177518|NCT01566045|Procedure|Core Needle MRI/US image fusion guided needle biopsy|Directed prostate needle biopsies at MR-image identified targets in addition to the standard ultrasound 12-14 core biopsies
16182251|NCT01529528|Drug|Anagliptin|Anagliptin 100mg, tablet, BID
16177480|NCT01566344|Other|PVC suppression therapy|Conventional heart failure therapy plus radiofrequency catheter ablation of PVCs as primary treatment and Amiodarone (tablets, loading dose of 600 mg per day for 4 weeks and 200 mg per day afterwards for at least 12 months) as secondary treatment in case of unsuccessful catheter ablation.
16177481|NCT01566331|Device|Baby-guardTM|Baby-guardTM system, through its ergonomic, three chamber, inflatable abdominal belt, engineered after studies of biomechanics and biophysics, that follows obstetric semiotics, that applies fundal pressure during the second stage of labor in the direction of the pelvic outlet, may be of maternal and fetus aid for a safe natural childbirth for their better outcomes
16177482|NCT01566318|Behavioral|Problem-Solving Therapy|6-8 sessions over 8 weeks, with booster
16177483|NCT01566305|Dietary Supplement|Buttermilk without added egg-yolk|Buttermilk without added egg-yolk
16177484|NCT01566305|Dietary Supplement|Buttermilk with added egg yolk|Buttermilk with added egg yolk
16177485|NCT01566305|Dietary Supplement|Skimmed milk with added egg-yolk|Skimmed milk with added egg-yolk
16177486|NCT01566305|Dietary Supplement|Skimmed milk without added egg yolk|Skimmed milk without added egg yolk
16177487|NCT01566292|Drug|BOTOX|Botulinum Toxin type A, 200-300 UI dilued in 6 ml of saline solution
16177488|NCT01566279|Drug|Everolimus|All patients will receive everolimus 10mg q.d.
16177489|NCT01566266|Drug|Amoxicillin|2 capsules of 250mg, 3 times per day during 1 week
16177490|NCT01566266|Drug|Placebo capsule|2 capsules of 250mg, 3 times per day during 1 week
16177491|NCT01566253|Drug|Acetaminophen, ketoprofen, morphine|Acetaminophen 0.5g, maximum 4g by day, 48 hours ketoprofen 100 mg, twice a day, 48 hours Morphine 10 mg, maximum 90 mg by day, 36 hours
16177492|NCT01566253|Drug|Acetaminophen, ketoprofen,morphine|Acetaminophen 1g/100 ml IV, maximum 4g by 24 hours, 48 hours Ketoprofen IV, maximum 0,2 gram by 24 hours, 48 hours Morphine IV,maximum 60mg by 24 hours, 36 hours.
16177493|NCT01566240|Drug|Paclitaxel|Paclitaxel 80 mg/m2 (capped at 162mg maximum total dose) weekly for 6 weeks i.e. on days 1, 8, 15, 22, 29 & 36.
16177494|NCT01566240|Drug|Carboplatin|Carboplatin AUC 2 (capped at 270mg maximum total dose) weekly for 6 weeks i.e. on day 1, 8, 15, 22, 29, & 36.
16177495|NCT01566240|Radiation|Radiotherapy|Radiotherapy comprising external beam 40-50.4Gy in 20-28 fractions plus intracavity brachytherapy to achieve a minimum total EQD2 dose of 78-86Gy.
16177496|NCT01566240|Drug|Cisplatin|Cisplatin 40 mg/m2 (capped at 70mg total dose) weekly for five weeks maximum, commencing in the first week of radiotherapy or as soon as blood counts have recovered from induction chemotherapy.
16177497|NCT01566227|Other|Questionnaire|3 surveys with 10 questions each: one before, during and after treatment
16177498|NCT01566214|Behavioral|Motivational Interview|For those subjects randomly assigned to the treatment group, information from their MIHART assessment interview and medical record review will be used to select intervention scripts optimally tailored to each subjects' unique configuration of beliefs and risk factors and they will be re-contacted by telephone at 2-weeks post-hospital discharge to deliver the Vet-HART intervention. The intervention will be administered by a trained research assistant via telephone, working from a semi-structured script tailored to each subject's representations and risk factors, the call will last about 15-30 minutes.
16177499|NCT01566201|Drug|anakinra|Inhibition of Interleukin-1 activity by anakinra (Kineret®) 100mg od, sc injection
16177500|NCT01566201|Drug|placebo|water for injection
16177501|NCT01566188|Dietary Supplement|omega-3 from vegetal origin|6 months of supplementation with omega-3 from vegetal origin
16177502|NCT01566188|Dietary Supplement|Placebo|6 months of supplementation with placebo
16177503|NCT01566175|Device|Neovac coronary sinus reducer|reducer
16177504|NCT01566162|Drug|Lurasidone|Lurasidone 40-80 mg taken orally taken once daily
16177505|NCT01566149|Drug|Mometasone Furoate/Formoterol Fumarate (MF/F) 100/5 mcg MDI|Two oral inhalations per dose
16177506|NCT01566149|Drug|Mometasone Furoate/Formoterol Fumarate (MF/F) 200/5 mcg MDI|Two oral inhalations per dose
16177507|NCT01566136|Behavioral|Rehabilitation Model of Care|The PCRM-CI model includes the following 5 components: rehabilitation management; dementia management; delirium prevention and management; staff education and support; and family/significant other support and education.
16177508|NCT01566123|Radiation|Neoadjuvant intensity-modulated radiation therapy (IMRT)|neoadjuvant intensity-modulated radiation therapy, single dose 2.0-2.4 Gy, total dose 50-56 Gy
16177509|NCT01566123|Radiation|intraoperative radiation therapy (IORT)|during surgery, 10-12 Gy (90% isodose) to the tumor bed or residual disease
16177510|NCT01566110|Dietary Supplement|Gluten Free Diet|Subjects assigned to the intervention group will receive a standardized dietary education intervention that will inform subjects and family members of the effects of gluten on the gastrointestinal tract and emphasize the need to adhere to a diet that is gluten-free. This intervention will be delivered by a dietician who is trained in celiac disease and gluten free diet.
16177511|NCT01566097|Device|Smoking Cessation Decision Aids|"The decision aids were developed through: 1) literature review; 2) qualitative interviews with Korean smokers from various backgrounds; 3) expert opinions. They were in the form of short educational videos (flash), displayed by Apple's iPad.
~The decision aids contained the followings, in proper Korean social and cultural context:
~Information on the risk of continued smoking and benefits of cessation
~Messages that address common misbeliefs regarding smoking cessation services and medications
~Information on possible smoking cessation options, their efficacy, side effects, costs, etc.
~The choices given in the decisions aid were:
~Behavioral only
~Nicotine replacement therapy
~Bupropion
~Varenicline"
16177512|NCT01566084|Drug|Slow sodium tablets|The normal salt condition is maintained with 2300 mg / day in the form of slowly released salt (NaCl) tablets.
16177513|NCT01566084|Other|placebo|Placebo tablets are administered to maintain the low sodium condition.
16177514|NCT01566071|Other|Assessment of drive abilities|
16177515|NCT01566058|Device|BB Box available|The BB Box video system is provided to the mother during the hospitalisation of her premature baby.
16177516|NCT01566058|Other|No BB Box|The BB Box video system is not provided to the mother during the hospitalisation of her premature baby.
16177517|NCT01566045|Procedure|Core Needle TRUS Needle biopsy (Transrectal ultrasound)|Standard of care 12-core TRUS sextant needle biopsy of the medial and lateral margins of the right and left apex, mid-gland and base of the prostate
16177519|NCT01566019|Procedure|Tumoral biopsy|Every enrolled patient undergoes tumoral biopsy
16177520|NCT01566006|Drug|Mycophenolate Mofetil (MMF) ,phosphodiesterase 5 inhibitors , CARNITINE|effect of MMF on diabetic nephropathy patients by evaluating its effect on proteinuria and progression of kidney disease of diabetic origin
16177521|NCT01565993|Device|Hemoclip|"A rotatable clip-fixing device Quickclip 2 standard was used (Olympus Medical Systems Corp. Hachioji-shi, Tokyo, Japan), with an opening diameter of 135º and a maximum insertion portion diameter of 2.6 mm"
16177522|NCT01565993|Device|Conventional Polipectomy|Disposable electrosurgical snares (Olympus Medical Systems Corp. Hachioji-shi, Tokyo, Japan) and an electrosurgery unit ERBE (ERBE Elektromedizin GmbH, Germany) were used for polyp resection
16177523|NCT01565980|Behavioral|symptom assessment|attention control receives a weekly symptom assessment phone interview for 6 weeks.
16177524|NCT01565980|Behavioral|Mindfulness Intervention|Participants will receive a weekly home-based mindfulness intervention, and symptom assessment phone interviews for 6 weeks.
16177525|NCT01565941|Drug|Insulin|IV insulin titration to target a blood glucose of 80-110 mg/dL
16177526|NCT01565941|Drug|Insulin|IV insulin titration to target a blood glucose of 150-180 mg/dL
16177527|NCT01565928|Drug|MDV3100|4 x 40 mg capsules, orally, once per day
16177528|NCT01565915|Device|Perlane-L|Perlane-L Injection in the midface
16177529|NCT01565915|Other|Non-treatment|Non-treatment Arm
16177530|NCT01565902|Drug|BAF312|Treatment with a single oral dose of 0.25 mg BAF312
16177531|NCT01565889|Drug|SOF|Sofosbuvir (SOF) 400 mg (1 × 400 mg tablet or 2 × 200 mg tablets) administered orally once daily
16177532|NCT01565889|Drug|EFV/FTC/TDF|Efavirenz (EFV) 600 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination (FDC) tablet administered orally once daily
16177533|NCT01565889|Drug|EFV|Efavirenz (EFV) 600 mg tablet administered orally once daily
16177534|NCT01565889|Drug|ZDV/3TC|Zidovudine (ZDV) 300 mg/lamivudine (3TC) 150 mg FDC tablet administered orally twice daily
16177535|NCT01565889|Drug|ATV|Atazanavir (ATV) 400 mg tablet administered orally once daily
16177536|NCT01565889|Drug|Ritonavir|Ritonavir (RTV) 100 mg tablet administered orally once daily
16177537|NCT01565889|Drug|FTC/TDF|FTC/TDF (200/300 mg) FDC tablet administered orally once daily
16177538|NCT01565889|Drug|DRV|Darunavir (DRV) 800 mg (2 × 400 mg tablets) administered orally once daily
16177539|NCT01565889|Drug|RAL|Raltegravir (RAL) 400 mg administered administered orally twice daily
16177540|NCT01565889|Drug|PEG|Pegylated interferon alfa (PEG) 180 μg administered once weekly by subcutaneous injection
16177541|NCT01565889|Drug|RBV|Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
16177542|NCT01565876|Device|"Minkal- Auxiliary device to alleviate backload"|"The participants will undergo 6 days of study. The first day of the study include medical examination, maximal oxigen consumption day and anthropometric mesurments.
~Then The participants will undergo heat tolerance test 5 times (in different days).
~first day- without load. second day- with back load of 40% of the body weight. third day- with back load of 40% of the body weight and the Auxilairy Device. fourth day- with back load of 60% of the body weight. fifth day- with back load of 60% of the body weight and the Auxilairy Device. The rectal temperature, skin teperature and heart rate will be mesured each day and compered afterwards."
16177543|NCT01565863|Behavioral|Progressive Goal Attainment Program|The Progressive Goal Attainment Program (PGAP) is a behavioral intervention originally developed in Canada at McGill University in order to increase return to work and community integration for individuals who receive worker's compensation. PGAP is the first disability program that is specifically designed to target the psycho-social risk factors of disability. The premise behind PGAP is that inactivity and attitudinal barriers increase work disability, and these issues are a primary cause of unemployment for individuals with physical and mental disabilities. PGAP is a structured, 10-week intervention that focuses upon helping clients develop a planned activity schedule to assist them in resuming desirable life activities.
16177544|NCT01565850|Drug|D/C/F/TAF|DRV 800 mg/COBI 150 mg/FTC 200 mg/TAF 10 mg FDC tablet administered orally once daily
16177545|NCT01565850|Drug|DRV|DRV 800 mg (2 × 400 mg tablets) administered orally once daily
16177546|NCT01565850|Drug|COBI|COBI 150 mg tablet administered orally once daily
16177547|NCT01565850|Drug|FTC/TDF|FTC 200 mg/TDF 300 mg FDC tablet administered orally once daily
16177548|NCT01565850|Drug|D/C/F/TAF Placebo|D/C/F/TAF placebo tablet administered orally once daily
16177549|NCT01565850|Drug|DRV Placebo|DRV placebo tablet administered orally once daily
16177550|NCT01565850|Drug|COBI Placebo|COBI placebo tablet administered orally once daily
16177551|NCT01565850|Drug|FTC/TDF Placebo|FTC/TDF placebo tablet administered orally once daily
16177552|NCT01565837|Drug|Ipilimumab|Ipilimumab 10mg/kg administered intravenously over 90-minute period every 3 weeks for a total of four doses as tolerated. Maintenance ipilimumab (10 mg/kg intravenously every 3 months) will be administered beginning Week 24, as long as there is clinical benefit in the opinion of the investigator using immune related response criteria, and there are no novel or unexpected Grade 3 or 4 toxicities.
16177553|NCT01565837|Radiation|Stereotactic Ablative Radiosurgery (SART)|Definitive radiotherapy will be administered to up to 1-5 lesions using SART techniques after initial dose of ipilimumab. Radiotherapy will be timed before start of 3rd cycle of ipilimumab treatment to maximize synergy (week 6).
16177554|NCT01565824|Other|web-based support|
16177555|NCT01565811|Procedure|perihepatic lymphadenectomy|Hepatic pedicle lymph node dissection according to the protocol of the prospective multicentric study.Namely the six main groups of lymph nodes removed (HA,hepatic artery; CA, celiac axis; BD, common bile duct).
16177556|NCT01565798|Other|Copper-alloy surfaced patient care objects|Copper-alloy surfaced bed rails, over bed tray tables, chair arms, nurse call devices, laptop and computer monitor bezels, and IV poles were placed into the patient ICU rooms.
16177557|NCT01565785|Behavioral|The FSM-DPI.|Nurses will assess key elements of family self-management (home care, child's care, practice, medications, watching child, recovery, development, family adjustment and parental support) and address any deficits to facilitate effective discharge and family management of child at home after hospitalization.
16177558|NCT01565772|Radiation|Proton Beam Radiation|45-55 Gy total, 1.8-2.2 Gy x 25 fractions Mon-Fri for 5 weeks
16177559|NCT01565772|Drug|Cisplatin|50 mg/m2 IV on days 1, 8 of cycles 1 and 2
16177561|NCT01565759|Drug|Lithium Carbonate|"The dose has been selected in order to achieve a therapeutic range of 0.6 - 0.8 mmol/L.
~Dose titration Day 1: 1 capsule of 300 mg at bedtime Days 2 to 7: 1 capsule of 600 mg at bedtime Day 8: lithium serum levels will be tested and the dose will be adjusted proportionally to a target range of 0.6 - 0.8 mmol/L by increments of 150 mg or 300 mg."
16177562|NCT01565746|Drug|Radium-223 dichloride (Xofigo, BAY88-8223)|Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg
16177563|NCT01565746|Drug|Radium-223 dichloride (Xofigo, BAY88-8223)|Radium-223 dichloride (Xofigo, BAY88-8223) 100 kBq/kg
16177564|NCT01565746|Drug|Radium-223 dichloride (Xofigo, BAY88-8223)|Expansion arm: Radium-223 dichloride (Xofigo, BAY88-8223) 50 kBq/kg
16177565|NCT01565733|Drug|biphasic insulin aspart 30|Biphasic insulin aspart 30 prescribed solely on the basis of clinical judgement. Initial dose, frequency of injections and further dosage amendments at the discretion of the treating physician.
16177566|NCT01565720|Drug|Isavuconazole|oral
16177567|NCT01565720|Drug|Placebo|oral
16177568|NCT01565720|Drug|Moxifloxacin|oral
16177569|NCT01565707|Drug|Solifenacin Succinate Suspension|Children aged 5 to 11 years and adolescents aged 12 to 17 years received solifenacin succinate liquid suspension once a day orally via syringe for 12 weeks along with non interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB. The initial dose started with the equivalent of 5 mg in adults, referred to as pediatric equivalent dose (PED) of 5 mg (PED5), based on body weight for three weeks and was titrated up or down in up to three titration steps of three weeks each to reach the optimal dose. Titration up or down could lead to weight-based doses equivalent to doses in adults of 2.5 mg, 5 mg, 7.5 mg or 10 mg once daily and were referred to as PED2.5, PED5, PED7.5 and PED10. The minimum dose was PED2.5, and the maximum dose was PED10. The decision to titrate up or down was made by the investigator using information from the 7 day patient diary.
16177570|NCT01565707|Drug|Placebo|Children aged 5 to 11 years and adolescents aged 12 to 17 years received matching placebo liquid suspension once a day orally via syringe for 12 weeks along with non interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB. The initial dose started with the equivalent of 5 mg in adults, referred to as pediatric equivalent dose (PED) of 5 mg (PED5), based on body weight for three weeks and was titrated up or down in up to three titration steps of three weeks each to reach the optimal dose. Titration up or down could lead to weight-based doses equivalent to doses in adults of 2.5 mg, 5 mg, 7.5 mg or 10 mg once daily and were referred to as PED2.5, PED5, PED7.5 and PED10. The minimum dose was PED2.5, and the maximum dose was PED10. The decision to titrate up or down was made by the investigator using information from the 7 day patient diary.
16177571|NCT01565707|Behavioral|Urotherapy|Non interventional diary assisted urotherapy consisting of overactive bladder (OAB) information, awareness, instruction, life-style advice and documentation of voiding habits and symptoms for OAB.
16177572|NCT01565694|Drug|Solifenacin succinate|Oral suspension administered once a day via syringe.
16177573|NCT01565681|Drug|ASP1240|infusion
16177574|NCT01565681|Drug|Placebo|infusion
16177575|NCT01565668|Drug|AC220|oral
16177576|NCT01565655|Drug|peficitinib|oral
16177577|NCT01565655|Drug|Placebo|oral
16177578|NCT01565642|Behavioral|Goals of care decision support|Decision aid and care plan meeting
16177579|NCT01565629|Behavioral|Computer assisted cognitive behavioral therapy.|Those who choose to participate will be required to attend 4 assessments - pre-treatment (week 0), mid-treatment (week 8), post-treatment, and a 4th assessment for a 3 month Follow-up. All children regardless of condition will follow the CCBT protocol (Camp Cope-A-lot), which is the computer-assisted intervention being examined in this study. The first 6 levels of this program are skill building levels to be completed by the user. The remaining 6 levels are completed with the therapist and consist of exposure tasks and rehearsal geared toward each child.
16177580|NCT01565616|Drug|Conditioning Regimen with Bone Marrow Transplant|"The bone marrow transplant regimen is below. Day 0 is the day of the transplant. The - sign is the number of days before and the + sign is the number of days after the transplant.
~Day -8 BU 3.2 mg/ kg/dose IV
~Day -7 BU 3.2 mg/kg/dose IV, FLU 35mg/m2 IV
~Day -6 BU 3.2 mg/kg/dose IV, FLU 35mg/m2 IV, ATG 0.5mg/kg IV
~Day -5 BU 3.2 mg/kg/dose IV, FLU 35mg/m2 IV, ATG 1.0mg/kg IV
~Day -4 FLU 35mg/m2 IV, ATG 1.5mg/kg IV
~Day -3 FLU 35mg/m2 IV, ATG 1.5mg/kg IV
~Day -2 ATG 1.5mg/kg IV
~Day -1 Rest
~Day 0 Stem cell infusion
~Graft Versus Host Disease (GVHD) Regimen
~Day -3 Calcineurin Inhibitor (Cyclosporine or Tacrolimus) therapeutic doses through day 180, then taper
~Day 0 Stem cell infusion
~Day +1 Methotrexate 7.5 mg/m2 IV
~Day +3 Methotrexate 7.5 mg/m2 IV
~Day +6 Methotrexate 7.5 mg/m2 IV
~Day+11 Methotrexate 7.5 mg/m2 IV"
16177581|NCT01565590|Drug|Dexmedetomidine|0.2-1.5 mcg/kg/hr
16177582|NCT01565590|Drug|propofol|5-80 mcg/kg/min
16177583|NCT01565577|Biological|MenbVac|Blood test
16177584|NCT01565564|Behavioral|Shared glycaemic control care within the local three-tier's antenatal care network|"Individualized dietary and physical activity consultation plus group diabetes education
~Self blood glucose monitoring
~Insulin therapy if indicated
~Self blood glucose monitoring
~Insulin therapy institutions if indicated;"
16177585|NCT01565551|Other|N/A (Observational Study)|No Interventions: Observational Study
16177586|NCT01565538|Drug|Erlotinib|150 mg Given orally
16177587|NCT01565538|Drug|Pemetrexed|500mg/m2 Given IV
16177588|NCT01565525|Behavioral|Maternal focused intervention|This is a series of information given to mothers at child's well child visits (6 in all) starting at the newborn visit focused in maternal eating habits, using the mother as a potential 'agent of change' for the family and infant in modeling healthy eating habits.
16177589|NCT01565525|Behavioral|Ounce of Prevention|This intervention is given via a series of handouts given to mothers at their child's well visit from newborn period to one year of age, focusing on serving size and frequency and the introduction of new foods.
16177590|NCT01565512|Drug|Bupivacaine|A total of 100 mg bupivacaine (20 mL of 5 mg/mL solution) administered once by subcutaneous injection while patient is under general anesthesia at end of operation.
16177591|NCT01565512|Drug|Saline|A total of 20 mL on injectable saline(0.9% NS) administered once by subcutaneous injection while patient is under general anesthesia at end of operation.
16177592|NCT01565499|Drug|Nab-paclitaxel|
16177891|NCT01563003|Other|Cognitive Behavioral Therapy|This condition involves 16 weekly CBT sessions.
16177593|NCT01565486|Device|Ultrasonic coagulation device (Harmonic ACE® scalpel)|Comparison of Surgical Outcomes Between Papillary Thyroid Cancer Patients Treated with the Ultrasonic coagulation device (Harmonic ACE® Scalpel) and the bipolar energy sealing system (LigaSure Precise) during Conventional Thyroidectomy
16177594|NCT01565486|Device|bipolar energy sealing system (LigaSure Precise)|Comparison of Surgical Outcomes Between Papillary Thyroid Cancer Patients Treated with the Ultrasonic coagulation device (Harmonic ACE® Scalpel) and the bipolar energy sealing system (LigaSure Precise) during Conventional Thyroidectomy
16177595|NCT01565460|Other|Sample Collection|Sample Collection: bile and pancreatic duct brushings and fluid samples will be obtained from the pancreatic stricture during endoscopic retrograde cholangiopancreatic procedure.
16177596|NCT01565434|Other|CR1 impact|
16177597|NCT01565408|Drug|NNC0114-0006|Multiple subcutaneous (s.c., under the skin) doses administered every second week for six weeks. The trial comprises dose escalation up to four dose levels. Progression to next dose will be based on safety evaluation.
16177598|NCT01565408|Drug|placebo|Multiple subcutaneous (s.c., under the skin) doses administered every second week for six weeks.
16177599|NCT01565395|Drug|Incobotulinum Toxin A|Xeomin 70-100 units injected in the parotid and submandibular glands of subjects
16177600|NCT01565395|Drug|placebo|Sterile preservative free 0.9% saline
16177601|NCT01565382|Drug|florbetapir F 18|IV injection, 370MBq (10mCi), single dose
16177602|NCT01565369|Drug|florbetapir F 18|IV injection, 370MBq (10mCi), single dose
16177603|NCT01565356|Drug|florbetapir F 18|IV injection, 111 or 370MBq (3 or 10mCi), single dose
16177604|NCT01565343|Drug|florbetapir F 18|IV injection, 370MBq (10mCi)
16177605|NCT01565330|Drug|florbetapir F 18|single dose IV injection
16177606|NCT01565317|Other|Weight Achievement and Intensive Treatment (Why WAIT)|Weight Achievement and Intensive Treatment (Why WAIT) is a 12 -week multidisciplinary program for weight control and intensive diabetes management designed by the Joslin Diabetes Center for application in a multidisciplinary diabetes practice environment. Participants will be enrolled in a 12-week multidisciplinary intensive weight management including diet, exercise, behavioral and educational support. Participants will be enrolled in cohorts of 10-15 participants to encourage group interaction and support. Subjects will choose to come to the Joslin clinic every Tuesday or Wednesday evening for 2 hours. Participants will exercise for an hour and will attend a didactic session in the areas of nutrition, exercise and behavioral modifications.
16177607|NCT01565304|Behavioral|POWER Through Choices|10-session group-based sexual education curriculum
16177608|NCT01565291|Drug|florbetapir F 18|IV injection, 370MBq (10mCi), single dose
16177609|NCT01565278|Drug|Soybean oil (Standard treatment)|1. Standard treatment: Soybean oil based emulsion: 0.25 g/kg/TPN day
16177610|NCT01565278|Drug|Soybean oil + Fish oil|Intralipid+Omegaven: 0.25 g/kg/TPN Intralipid day+0.4 g/kg/TPN Omegaven day for 6 months
16177611|NCT01565265|Drug|Pergoveris in long protocol with GnRH agonist|Ovarian hyperstimulation with recombinant FSH and recombinant FSH Ovulation induction with recombinant HCG Oocyte collection for ICSI
16177612|NCT01565265|Drug|Pergoveris in GnRH antagonist protocol|Ovarian hyperstimulation with recombinant FSH and recombinant FSH Ovulation induction with recombinant HCG Oocyte collection for ICSI
16177613|NCT01565252|Dietary Supplement|eggs enriched Omega-3|In second stage participants will receive two Omega-3 enriched hard-boiled eggs/day at breakfast for a three weeks period for each participant.
16177614|NCT01565239|Device|Fiix prothrombin time|The Fiix prothrombin time (or Stuart-prothrombin time) is a new modification of the currently used prothrombin times. The Fiix PT as opposed to PT is sensitive to the activity of coagulation factors II and X only whereas the PT is sensitive to factors I, II, V, VII and X.
16177615|NCT01565213|Behavioral|CBT|group cognitive behavioural based therapy (CBT) administered by psychologists once a week for 12 weeks,
16177616|NCT01565213|Behavioral|MMI|group multimodal intervention (MMI) based on a protocol comprising a mix of existing group interventions and exercises borrowed from multiple techniques and therapeutic schools and administered by assistant nurses with brief training, including two sessions per week for 6 weeks.
16177617|NCT01565213|Behavioral|CAU|Care as usual by the GPs
16177618|NCT01565200|Drug|T-DM1|3.6 mg/kg iv every 3 weeks
16177619|NCT01565200|Procedure|89Zr-trastuzumab|Injection of 89Zr-trastuzumab for HER2 imaging
16177620|NCT01565187|Behavioral|Questionnaires|Transplant Effects Questionnaire, Response Evaluation Measure, Patient Health Questionnaire, Generalized Anxiety Scale, Alcohol Use Disorders Test, Body Image Questionnaire, Quality of Life Uniscale, Scales of Psychosocial Well-Being, Sense of Coherence Scale.
16177621|NCT01565161|Behavioral|Home-Based Health Coaching|"The 6-month intervention arm consists of 3 components:
~In-home coaching visits with a health educator trained in motivational interviewing to encourage behavior change. In addition to 4 monthly in-home coaching visits, participants receive 4 monthly coaching phone calls to supplement the in-person visits.
~Use of mobile technology to deliver health information by text message - participants receive messages twice weekly for 16 weeks and then weekly for 8 weeks of the program. Those without a phone capable of receiving text messages receive postcards by mail.
~Printed materials, including educational handouts, newsletters, and activities highlighting target behaviors, sent monthly for 4 months."
16177622|NCT01565161|Behavioral|Mailed materials|"We designed materials for our control group focusing on Developmental milestones during early childhood to provide information that participants would find relevant and helpful for parenting, but that would also not influence intervention behaviors, such as TV viewing or household routines related to sleeping, eating, or television viewing.
~Participants received 4 monthly mailing packages, each focusing thematically on one of four milestone domains: motor, language, cognitive and social/emotional. Educational materials were adapted from the Center for Disease Control's Positive Parenting Tips for Healthy Child Development, and the mailing included child-appropriate incentives to reinforce the concepts presented in the educational materials."
16177623|NCT01565148|Drug|iCo-007 350 mcg|iCo-007 (350 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (350 μg) at month 4
16177624|NCT01565148|Drug|iCo-007 700 mcg|iCo-007 (700 μg) as an intravitreal injection at baseline followed by another iCo-007 dose (700 μg) at month 4
16177666|NCT01564797|Behavioral|Home Health Party|An education-based lay health educator-led intervention designed to educate Hispanic participants with elevated HA1c levels about diabetes, treatment of diabetes, and diet and lifestyle changes.
16177625|NCT01565148|Drug|iCo-007 350 mcg and Laser|iCo-007 (350 μg) as an intravitreal injection at baseline followed 7 days later by laser photocoagulation. At M4, intravitreal injection of iCo-007 (350 μg) will be given as mandatory treatment. If the eye also meets retreatment criteria, it will also receive the second laser photocoagulation
16177626|NCT01565148|Drug|Ranibizumab and iCo-007 350 mcg|Ranibizumab (0.5 mg) intravitreal injection at baseline followed by iCo-007 (350 μg) intravitreal injection 2 weeks later; re-treatment with ranibizumab (0.5 mg) mandatory at M4 followed by iCo-007 (350 μg) 2 weeks later
16177627|NCT01565135|Behavioral|Multimodal Vaccine Program|"Efforts will be made to collaborate with private ob/gyn offices to develop a multimodal intervention to improve patients'immunization rates. As part of the overall intervention, intervention practices will agree to 1) purchase, stock, and administer influenza, HPV, and Tdap vaccines, if not already doing so and 2) track patients' vaccination status. In addition, intervention strategies adopted by intervention settings to improve immunization rates may include:
~Patient education regarding the importance of vaccination, including encouragement of vaccination for family members
~Practice-based reminder/recall
~Seek to decrease missed opportunities for immunization by using either or both of the following: provider prompts and/or provider education and feedback"
16177628|NCT01565109|Drug|Docetaxel - Cisplatine - 5FU|2 cycles of Docetaxel - Cisplatine - 5 FU
16177629|NCT01565109|Radiation|Radiation of 45 Grays on 5 weeks|Radiochemotherapy with Oxaliplatine (J1, J15 et J29) - 5FU on 5 weeks
16177630|NCT01565096|Drug|Metformin|Metformin 1000 mg BID
16177631|NCT01565096|Drug|Metformin|Metformin 1000 mg BID
16177632|NCT01565096|Drug|Vildagliptin|Vildagliptin 50 mg twice daily
16177633|NCT01565096|Drug|Glimepiride|Glimepiride at individual dose
16177634|NCT01565083|Drug|Pertuzumab|Loading dose of 840 mg on Day 1 of first 21-day cycle, followed by 420 mg on Day 1 of each subsequent cycle.
16177635|NCT01565083|Drug|Trastuzumab|Loading dose of 8 mg/kg on Day 1 of first 21-day cycle, followed by 6 mg/kg on Day 1 or 2 of each subsequent cycle.
16177636|NCT01565083|Drug|Vinorelbine|A dose of 25 mg/m^2 followed by 30-35 mg/m^2 on Days 2 and 9 of the first 21-day cycle and on Days 1 and 8 (or Days 2 and 9) of each subsequent cycle.
16177637|NCT01565070|Drug|Biofreeze|Use of Biofreeze ointment
16177638|NCT01565070|Other|Placebo|Use of placebo ointment
16177639|NCT01565057|Other|sedimenting meal|The active system quickly forms a sedimenting layer of small particles that contain most of the caloric content of the system. This system is made by adding finely grated cheese (particle size 0.5-2 mm) to yoghurt and consumption is followed by drinking 327 ml water.
16177640|NCT01565044|Other|motor training|Subject will perform prehension exercises on an automated table. After the initiation of the arm movement, the target to be grasped is programmed to move in order to stimulate automatic motricity.
16177641|NCT01565044|Other|motor training|Subject will perform prehension exercises on an automated table. After the initiation of the arm movement, the target to be grasped will remain static in order to involve intentional motricity.
16177642|NCT01565031|Procedure|Step-wise down-titration according to international guidelines.|The medication will be adjusted according to each patient´s level of control. Depending on the state of control of asthma, the dose will be adjusted up or down (step-up therapy and step-down therapy, respectively) in accordance with GINA.
16177643|NCT01565018|Drug|Rotigotine PR 2.1.4|Treatment B: Rotigotine transdermal patch (2 mg/24 h [10 cm^2]). Reference; drug product PR 2.1.4. Single application of 1 patch for 24 hours.
16177644|NCT01565018|Drug|Rotigotine PR 2.2.1|Treatment A: Rotigotine transdermal patch (2 mg/24 h [10 cm^2]). Test; drug product PR 2.2.1. Single application of 1 patch for 24 hours.
16177645|NCT01564992|Other|Identification of genes|Identification of genes which polymorphism or haplotype is associated with a complication of Parkinson disease, directly or with the interaction of treatment.
16177646|NCT01564979|Drug|preseptal injection of botulinum toxin type A|botulinum toxin type A (Botox)2.5 units, 5 points
16177647|NCT01564979|Drug|pretarsal injection of Botulinum toxin type A|Botulinum toxin type A 2,5 units, 5 points
16177648|NCT01564927|Device|Electroacupuncture to right LI4 and LI11 (ITO, EX-160)|Electroacupuncture at 2Hz, 0.4m/sec pulse duration
16177649|NCT01564927|Device|Sham Electroacupuncture to knee caps|Electroacupuncture at 2Hz, 0.4m/sec pulse duration
16177650|NCT01564927|Device|Sham electroacupuncture to LI4 and LI11|Electroacupuncture at 2Hz, 0.4m/sec pulse duration
16177651|NCT01564914|Drug|TRC105|10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle
16177652|NCT01564914|Drug|Bevacizumab|IV
16177653|NCT01564888|Procedure|Ulnar artery compression|Compression of ulnar artery for 2 hours with radial artery hemostasis
16177654|NCT01564875|Drug|Simvast CR|Simvast CR Tab 20mg, 1 tablet once daily to be administered between 6 and 9 a.m.
16177655|NCT01564875|Drug|Zocor|Zocor Tab 20mg, 1 tablet once daily to be administered between 6 and 9 p.m.
16177656|NCT01564862|Drug|vortioxetine (Lu AA21004)|Lu AA21004 capsules
16177657|NCT01564862|Drug|Duloxetine|Duloxetine capsules
16177658|NCT01564862|Drug|Placebo|Placebo matching capsules
16177659|NCT01564836|Behavioral|Imatinib treatment discontinuing|Ph+ CP CML patients who were treated with IM for more than 3 years in sustained MR4.5 or undetectable transcript for at least 2 years are enrolled
16177660|NCT01564823|Drug|Metronidazole|Metronidazole: 250 mg/8h. 3 months.
16177661|NCT01564823|Drug|Metronidazole|Metronidazole 250 mg/8h 3 months
16177662|NCT01564823|Drug|Azathioprine|Azathioprine: 2.5 mg/kg of weight/day. 3 months.
16177663|NCT01564823|Drug|Adalimumab|Adalimumab 160 mg then 80 mg. After 2 wk: 40 mg as maintenance.
16177664|NCT01564810|Drug|Cetuximab|On day 1 of a 14 day treatment cycle, patients received a 2-hour infusion of cetuximab (initial dose 400 mg/m2 in week 1, and 250 mg/m2 weekly during 1 hour thereafter) followed after 1 hour by chemotherapy of FOLFOX or FOLFIRI until progressive disease or unacceptable toxicity.
16177665|NCT01564810|Drug|chemotherapy of mFOLFOX6 or FOLFIRI|FOLFOX-4 (oxaliplatin, 85mg/m2 on day 1 infused during 2 hours;LV200mg/m2ondays 1and 2 infused during 2 hours, together with or following oxaliplatin; followed by FU 400 mg/m2 intravenous bolus then 600 mg/m2 intravenous infusion over 22 hours on days 1 and 2) FOLFIRI(irinotecan 180mg/m2 on day 1 infused during 2 hours; fluorouracil in a bolus of 400 mg/m2 and then continuous infusion for 46 hours of 2400 mg/m2)
16177670|NCT01564784|Drug|cytarabine and mitoxantrone|mitoxantrone 12 mg/m^2 IV days 1-3 cytarabine 200 mg/m^2/day IV over 7 days cycle length: 15-20 days Total number of cycles: 4
16177671|NCT01564771|Other|Non Intervention|This Is A Non Interventional Study
16177672|NCT01564758|Drug|Linezolid|"Vancomycin-resistant, E. faecium, including concurrent bacteremia: Linezolid for 600mg (IV or oral) every 12 hours for 14-28 days
~Nosocomial infection, cSSTI: Linezolid for 600mg (IV or oral) every 12 hours for 10-14 days
~Uncomplicated SSTI: Linezolid for 400mg oral every 12 hours for 10-14 days"
16177673|NCT01564745|Other|Functional respiratory evaluation|Each enrolled patients has a pulmonary function test before and after extubation, and repeatedly at D1, D3, D5 (if they are always hospitalized)
16177674|NCT01564732|Device|Standard-LAGB|The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures.
16177675|NCT01564732|Device|Plicated-LAGB|"At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to tighten and cinch up the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss."
16177676|NCT01564719|Behavioral|Holistic health|The investigators conceptualize this as a holistic health intervention because it has components involving the mind, body, and spirit. The stress reduction program Williams LifeSkills, adapted for clergy; the 10-session online weight loss program Naturally Slim Foundations plus its 7-session online booster program, Naturally Slim Advanced; monthly phone conversations with Wellness Advocates who function as health coaches; $500 small grants to use to promote health; and three in-person workshops that cover the theology of the body and incarnation and provide the religious rationale for caring for the mind and body.
16177677|NCT01564706|Drug|florbetapir F 18|IV injection, 370MBq (10mCi), single dose
16177678|NCT01564680|Other|placebo|normal saline
16177679|NCT01564680|Drug|Paracetamol|IV paracetamol infusion
16177680|NCT01564680|Drug|Lornoxicam|16 mg at skin closure and 8 mg 12 hours postoperative
16177681|NCT01564667|Behavioral|Attention Bias Modification Training Protocol|Attention Bias Modification computerized training sessions administered 2 times per week for 4 weeks making a total of 8 training sessions.
16177682|NCT01564654|Device|iTotal KRS|Total Knee Replacement System
16177683|NCT01564641|Device|iDuo G2|single comparator
16177684|NCT01564628|Device|CADScor1|Acoustic recording
16177685|NCT01564615|Device|Umbilical catheterization (AgION )|Infants received a AgION impregnated catheter (4.0-5.0 F Lifecath PICC ExpertTM, Vygon, Ecouen, France).
16177686|NCT01564615|Device|Umbilical catheterization (ArgyleTM)|Infants received a polyurethane non-impregnated catheter (3.5-5.0 F ArgyleTM, Kendall, Tullamore, Iceland)
16177687|NCT01564602|Device|comparison multiple channel port laparoscopic surgery|to compare 2-channel single port and multiple channel port laparoscopic surgery
16177688|NCT01564576|Drug|Profound neuromuscular blockade (Rocuronium, Rocuronium bromide, sugammadex, Bridion)|Rocuronium dose will be adjusted to maintain a depth of NMB of zero response to train of four and a post tetanic count of no more than 10 responses. At the end of surgery patients will receive a single bolus dose of 4 mg/kg sugammadex according to ideal body weight + 40%12. Extubation will be performed when train-of-four ratios ≥ 0.9.
16177689|NCT01564563|Drug|standard therapy|Standard treatment of bleeding
16177690|NCT01564563|Drug|placebo|Placebo
16177691|NCT01564563|Drug|activated recombinant human factor VII|Two days repeated treatment regimen - low dose administered i.v. (into the vein)
16177692|NCT01564563|Drug|activated recombinant human factor VII|Two days repeated treatment regimen - high dose administered i.v. (into the vein)
16177693|NCT01564550|Drug|Insulin|Insulin is given as a constant infusion( 0,6 mU/kg/min) during the hyperinsulinemia period of the study lasting four and a half hour.
16177694|NCT01564550|Drug|insulin|Insulin is given as a constant infusion( 0,6 mU/kg/min) during the hyperinsulinemia period of the study lasting four and a half hour.
16177695|NCT01564550|Other|diet|The subjects ingest a three day isocaloric diet (55 % carbohydrate,30% fat, 15 % protein)prior to the study day.
16177696|NCT01564550|Other|no diet|The subjects will ingest a non-restricted diet prior to the study day.
16177697|NCT01564537|Drug|Ixazomib|Ixazomib capsules
16177698|NCT01564537|Drug|Lenalidomide|Lenalidomide capsules
16177699|NCT01564537|Drug|Dexamethasone|Dexamethasone tablets
16177700|NCT01564537|Drug|Placebo|Ixazomib placebo-matching capsules
16177701|NCT01564524|Procedure|Fat graft surgical procedure|The fat graft surgical procedure will concentrate the adipose stromal cells (ASCs) in the fat graft material. A blunt tip hollow cannula is used to aspirate approximately 200-400cc of fat tissue. The aspirated fat is divided into two portions: one portion will be processed as standard graft material, the other portion will be used in a processing step that concentrates the ASCs. The aspirated fat processed as standard graft material will be divided into small alioquots and centrifuged to separate the aqueous and oil layers, and transferred into 1ml syringes. Standard fat graft material will serve as a control treatment and will be injected into one area of the face. The ASC concentrated graft material will be processed so it first separates the ASCs in a brief collagenase digestion and then resuspends the ASCs in the native fat tissue from which the stromal cells were derived. The ASC concentrated fat will be injected into another region of the face.
16177702|NCT01564511|Device|Gait trainer treatment|Patients will be subjected to 40 minutes of repetitive locomotor therapy on the Gait Trainer (GTI) (Reha-Stim, Berlin, Germany), followed by 10 minutes of passive joint mobilization and stretching exercises. The first 40 min session will be divided as follow: 15 min gait training; 5 minutes at rest; 15 minutes gait training; 5 minutes at rest. The GT-I consists of a double crank and rocker gear system, composed of two footplates positioned on two bars (coupler), two rockers, and two cranks that provide the propulsion.
16177733|NCT01564238|Other|High sodium diet (3.8 g/d)|20 day controlled feeding study (live in) providing 3.8 grams per day of sodium.
16177734|NCT01564225|Drug|EDI200|Cohort 1 will be dosed at 3 mg/kg/dose. Cohort 2 will be dosed at 10 mg/kg/dose. Both cohorts will receive 2 doses/week for a total of 5 doses.
16177703|NCT01564511|Other|Conventional treatment|The control group will be subjected to a conventional treatment that will consist of three different sets of exercises: 1) passive joint mobilization and stretching of lower limb muscles; 2) muscle strengthening exercises; 3) gait exercises. Each set of exercises lasted 10, 15 and 15 min, respectively with 2,5 min at rest between each set for a total of 40 minutes.
16177704|NCT01564498|Other|vegetable|200-300 g raw carrots or 300-500 g cooked potatoes
16177705|NCT01564485|Diagnostic Test|Cardiac CT|A cardiac CT involves a non-invasive test of the coronary arteries.
16177706|NCT01564485|Behavioral|Usual medical care|Patients would be treated by their primary care physicians with usual medical care with drugs such as lipid lowering medication, blood pressure lowering medications, and blood glucose lowering medications. The study will not specify which drugs to use and will it up to the individual physician's discretion.
16177707|NCT01564472|Other|PSG Scoring|No participants will be enrolled and no interventions, besides PSG scoring will be utilized.
16177708|NCT01564459|Drug|MK-6096|MK-6096 10 mg compressed tablets, taken once daily at bedtime for 14 days.
16177709|NCT01564459|Drug|Placebo|Matching compressed tablets, taken once daily at bedtime for 14 days.
16177710|NCT01564446|Other|Participants will receive a internet based secure message confirming adherence to post-discharge medication regimen|Participants will receive a internet based secure message via My HealtheVet (MHV), The VA's online medical record and secure messaging portal. The message will specify post-discharge prescribed medications and inquire about adherence to these medications.
16177711|NCT01564433|Procedure|Device: Electromechanical gait trainer|The experimental group will be subjected to 12-30 minute session (3 per week: Monday, Wednesday, Friday) of repetitive locomotor therapy on the Gait Trainer (Reha-Stim, Berlin, Germany), followed by 20 minutes of passive joint mobilization and stretching exercises. The GT-I consists of a double crank and rocker gear system, composed of two footplates positioned on two bars (coupler), two rockers, and two cranks that provide the propulsion. While using the gait trainer, individuals are secured in a harness and positioned on two footplates, whose movements simulate stance and swing phase, with a ratio of 60% to 40% between the two phases. The body weight was initially reduced by 30% and then progressively increased.
16177712|NCT01564433|Procedure|Convetional control treatment|The control group will be subjected to a conventional treatment that will consist of three different sets of exercises: 1) passive joint mobilization and stretching of lower limb muscles; 2) muscle strengthening exercises; 3) gait exercises. Each set of exercises lasted 10, 15 and 15 min, respectively with 2,5 min at rest between each set for a total of 40 minutes.
16177713|NCT01564407|Drug|ICX-RHY-013|"Drug Dosing for Cohorts as follows:
~Cohorts (N=4)
~Safety Cohort 1:
~Empty control no injection
~Vehicle only (0.5 ml of HypoThermosol solution)
~5 million cells / cm² , single administration at Day 0
~5 million cells/ cm² , single administration at week 4
~5 million cells/cm² , single administration at Day 0 , repeat administration of this dose @ week 4
~At day 0, the subject will receive a total of 3 different injections and at week 4 the subject will receive a total of 2 different injections.
~Cohort 2: 2.5 million cells/ cm2, single administration Cohort 3: 5 million cells /cm2, single administration Cohort 4: 2.5 million cells/ cm2, repeat dose administration @ 4 weeks Cohort 5: 5million cells / cm2 repeat dose administration @ 4 weeks"
16177714|NCT01564394|Behavioral|Qigong|Classes will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. The classes will be led by a trained Qigong instructor and consist of postures, movements, deep breathing techniques and meditation. It will include eccentrically-biased Qigong movements with an emphasis on weight shifting and posture control. The continuous body movements coupled with progressively diminishing base of support, dynamic challenge to balance, and concentration on body positions requiring eccentric muscle activity should improve the levels of fatigue and quality of life in older prostate cancer survivors.
16177715|NCT01564394|Behavioral|Non-aerobic stretching|The non-aerobic stretching classes will serve as an attention control. They will be 60 minutes in duration, held two times a week, supplemented with home-based sessions over 12 weeks. They will be led by an Huntsman Cancer Institute (HCI) fitness specialist and will consist of light stretching exercises; while avoiding a focus on meditation.
16177716|NCT01564381|Dietary Supplement|ResA|90mg of resveratrol conjugated with arginine.
16177717|NCT01564381|Dietary Supplement|Resveratrol|90mg of resveratrol.
16177718|NCT01564381|Dietary Supplement|Placebo|Made up of cellulose.
16177719|NCT01564368|Procedure|diffusion-weighted magnetic resonance imaging|diffusion-weighted magnetic resonance imaging examination and subsequent radiologist interpretation
16177720|NCT01564355|Device|Steroid-eluting middle meatal spacer (Nasopore (TM) spacer impregnated with 1 cc of 40mg/mL triamcinolone liquid)|All study arms will receive bilateral Nasopore spacers impregnated with 1 cc of Triamcinolone to remain in the nasal cavity for 1 week post-operatively as per usual protocol.
16177721|NCT01564355|Drug|Post-op Oral Steroids|Post-operative oral prednisone 20 mg QD x 5 days , then 10 mg x 5 days, as per usual protocol.
16177722|NCT01564342|Procedure|wound irrigation with study fluid|wounds were either irrigated with sterile normal saline or tap water.
16177723|NCT01564329|Drug|endostar|Endostar TM 7.5mg/m2,intravenous drip, Day 1to Day 10;Pemetrexed 500mg/m2, intravenous drip, Day 6; Carboplatin AUC=5,intravenous drip, Day 6; 21 days as a cycle, 4 cycles in all.
16177724|NCT01564303|Drug|Acetylcysteine, Phosphodiesterase type 5 inhibitor ,Carnitine|to evaluate the effect of the above agents on Kidney functioning parameters
16177725|NCT01564290|Dietary Supplement|Probiotic yogurt|Lactobacilus Rhamnonsus 100000000 UFC per mL. Dosage 50 mL twice daily fo 5 days.
16177726|NCT01564290|Drug|Placebo probiotic|Lyophilized probiotic, containing 250 mg per sachet dosage to about 2 times a day for 5 days.
16177727|NCT01564277|Drug|rasburicase|Given IV
16177728|NCT01564277|Drug|allopurinol|Given PO
16177729|NCT01564264|Procedure|Sentinel Lymph Node Biopsy|Sentinel node biopsy after injections of 0.4 mci of Technetium 99 in the cervix and 4 mL of Patent Blue into the myometrium followed by standard retroperitoneal lymph node dissection
16177730|NCT01564251|Drug|GDC-0575|Participants will receive GDC-0575 orally at a starting dose of 15 mg.
16177731|NCT01564251|Drug|Gemcitabine|Participants will receive gemcitabine intravenously at a dose of 1000 mg/m^2 and/or 500 mg/m^2.
16177732|NCT01564238|Other|Low Na diet (1.3 g/d)|20 day controlled feeding study (live in) providing 1.3 grams per day of sodium.
16182468|NCT01528111|Drug|LX7101 Vehicle|Subjects will receive vehicle
16177735|NCT01564212|Other|standard airflow with forced air warming.|Subjects will lie on operating room bed with standard airflow and forced air warming.
16177736|NCT01564212|Other|laminar airflow with surgical drapes|
16177737|NCT01564212|Other|laminar airflow with forced air warming|Subjects will lie on operating room bed with laminar airflow and forced air warming.
16177738|NCT01564212|Other|standard airflow with surgical drapes|Subjects will lie on operating room bed with standard airflow on and surgical drapes surrounding bed.
16177739|NCT01564199|Drug|salmeterol / fluticasone propionate|100/1000 μg oral capsule
16177740|NCT01564160|Dietary Supplement|Fish Oil|Source of omega-3 fatty acids.
16177741|NCT01564160|Dietary Supplement|PCSO-524|Extract of Greenshell Mussel
16177742|NCT01564147|Other|immediate therapeutic education|Access to the course of immediate therapeutic education
16177743|NCT01564147|Other|therapeutic education delayed|Group receiving therapeutic education 6 months later (control group)
16177744|NCT01564134|Biological|hepatitis B vaccine|hepatitis B vaccine with 5ug,10ug,20ug,60ug HBsAg
16177745|NCT01564121|Drug|acid Zoledronic|Treatment with zoledronic acid will be initiated during hospitalization, the day after the removal of redundant. Intravenous injection of 4 mg. of zoledronate diluted in sodium chloride 9 / 1000 or a solution of 5% dextrose in intravenous over 15 minutes. In the absence of intolerance clinic, an infusion of zoledronic acid in the same doses and modalities will be performed in a hospital (on the occasion of a follow-up visit after surgery) at the 3rd, 6th, 9th and 12th weeks after the first, or 5 injections. )
16177746|NCT01564108|Drug|Ranibizumab|Series of intravitreal injections of Ranibizumab
16177747|NCT01564095|Drug|Tacrolimus|Marginal liver grafts are flushed with Tacrolimus (20ng/ml) solved in 1000 ml HTK preservation solution (duration: 15 min) ex vivo at the end of backtable preparation in the experimental group.
16177748|NCT01564095|Drug|HTK/Placebo|Marginal liver grafts are flushed with 1000 ml HTK preservation solution(duration: 15 min) ex vivo at the end of backtable preparation in the placebo group.
16177749|NCT01564082|Device|ETT First (GlideScope)|Patients will have the endotracheal tube (ETT) introduced into the pharynx under direct vision prior to GlideScope insertion. The ETT will then be advanced under GlideScope guidance into the trachea.
16177750|NCT01564056|Drug|HORMONOTHERAPY|"Hormonotherapy will be administered during 5 years following chemotherapy when allocated.
~(Tamoxifen, aromatase inhibitor or sequential hormonotherapy) is left to the investigator judgement in both groups (I and II)."
16177751|NCT01564056|Drug|CHEMOTHERAPY then HORMONOTHERAPY|"CHEMOTHERAPY regimen will be chosen amongst the following ones:
~i) 4 cycles of TC (docetaxel + cyclophosphamide)
~Docetaxel 75 mg/m² IV infusion at hospital every 21 days
~Cyclophosphamide 600 mg/m² IV infusion at hospital every 21 days
~ii) 4 cycles of AC (doxorubicin + cyclophosphamide)
~Doxorubicin 60 mg/m² IV infusion at hospital every 21 days
~Cyclophosphamide 600 mg/m² IV infusion at hospital every 21 days
~iii) 4 cycles of MC (liposomal non pegylated doxorubicin [Myocet®]+ cyclophosphamide)
~Myocet® 60 mg/m² IV infusion at hospital every 21 days
~Cyclophosphamide 600 mg/m² IV infusion at hospital every 21 days
~HORMONOTHERAPY (Tamoxifen, aromatase inhibitor or sequential hormonotherapy) is left to the investigator judgement in both groups (I and II)."
16177752|NCT01564043|Behavioral|website and pedometer|use of pedometer and website
16177753|NCT01564030|Other|Empty|overnight fast
16177754|NCT01564030|Other|Fluid|250mL apple juice
16177755|NCT01564030|Other|Solid|breakfast
16177756|NCT01564017|Biological|Allergovac depot|"Depot sterile suspension fpor subcutaneous injection
~Increasing concentrations to reach the following maintenance doses:
~Group 1: 0.25 SPT"
16177757|NCT01564017|Biological|Allergovac depot|"Depot sterile suspension for subcutaneous injection.
~Increasing concentrations to reach the following maintenance doses:
~Group 2: 0.5 SPT"
16177758|NCT01564017|Biological|Allergovac depot|"Depot sterile suspension for subcutaneous injection.
~Increasing concentrations to reach the following maintenance doses:
~Group 3: 1 SPT"
16177759|NCT01564017|Biological|Allergovac depot|"depot sterile suspension for subcutaneous injection
~Increasing concentrations to reach the following maintenance doses:
~Group 4: 2 SPT"
16177760|NCT01564017|Biological|Allergovac depot|"Depot sterile suspension for subcutaneous injection.
~Increasing concentrations to reach the following maintenance doses:
~Group 5: 4 SPT"
16177761|NCT01564017|Biological|Allergovac depot|"Sterile suspension for subcutaneous injection.
~Same number of administration as the active groups"
16177762|NCT01564004|Other|Clinical hypnosis or neuro-linguistic programming|20 minutes tape recording intervention
16177763|NCT01563991|Procedure|Normal fluid volume|Normal fluid group will receive lactated ringes at 8 cc / Kg/ hr total
16177764|NCT01563991|Procedure|Reduced fluid volume|Subject receives 80 cc/ hr LR during the peri-operative period
16177765|NCT01563978|Drug|fostamatinib|fostamatinib 100 mg twice daily
16177766|NCT01563978|Drug|placebo|placebo
16177767|NCT01563965|Dietary Supplement|Carbohydrate plus hydrolyzed protein beverage|The study group received 400 ml (evening drink) or 200 ml (3h prior to operation drink) of a solution containing 11% de protein (pea hydrolized proptein), 89% de carbohydrates (maltodextrin 79% and saccharose 21%) e 0% of lipids (Providextra, Fresenius Kabi, São Paulo, Brasil). All the patients fasted for solids at least 6 hours from the operation
16177768|NCT01563965|Other|Preoperative fasting of 8h|Conventional protocol of 8h fasting before an operation
16177769|NCT01563952|Device|Non-IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic)|2x2 randomization by the treatment of IVUS-guided intervention vs. Non-IVUS guided intervention and the types of the implanted DES, Endeavor-R vs. Nobori.
16177770|NCT01563952|Device|IVUS guided intervention with Endeavor Resolute stent (zotarolimus-eluting stent, Medtronic)|2x2 randomization by the treatment of IVUS-guided intervention vs. Non-IVUS guided intervention and the types of the implanted DES, Endeavor-R vs. Nobori.
16177771|NCT01563952|Device|Non-IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo)|2x2 randomization by the treatment of IVUS-guided intervention vs. Non-IVUS guided intervention and the types of the implanted DES, Endeavor-R vs. Nobori.
16177772|NCT01563952|Device|IVUS guided intervention with Nobori stent (biolimus A9-eluting stent, Terumo)|2x2 randomization by the treatment of IVUS-guided intervention vs. Non-IVUS guided intervention and the types of the implanted DES, Endeavor-R vs. Nobori.
16182851|NCT01525407|Drug|Atorvastatin Calcium|Given PO
16177773|NCT01563939|Drug|Remifentanil|"Remifentanil IV for continuous infusion: 0.025mcg/kg/min, increased by 0.025mcg/kg/min every 15 min if patient is not satisfied, to a maximum of 0.15mcg/kg/min.
~Remifentanil IV for demand bolus: 0.2 mcg/kg, lockout 2 min, incrementally increased if patient is not satisfied by 0.2 mcg/kg to a maximum of 1.2 mcg/kg."
16177774|NCT01563926|Drug|somatropin|Dosed by individual needs as judged by the Investigator (trial physician). Injected subcutaneously (s.c./under the skin)
16177775|NCT01563913|Drug|Docosahexaenoic Acid (DHA)|Docosahexaenoic Acid (DHA) 2 grams per day taken for 1.5 years
16177776|NCT01563913|Drug|Placebo|Sugar Pill, taken for 1.5 years
16177777|NCT01563900|Device|Auto-titration CPAP|An auto-titration CPAP will be set at a pressure between 5 to 15 cwp. This device delivers pressure as needed by the patient at any given time while using the device.
16177778|NCT01563900|Device|Sham-CPAP|The sham-CPAP device will be set at 4 centimeters of water pressure (cwp). An exhalation connector will be place between the mask interface and the tubing without the enlarged port to maintain blinding; the final pressure delivered to the participant will be 2 cwp.
16177779|NCT01563887|Behavioral|DD.com|Internet intervention in which participants will complete 6 Cores, or classes over the internet, focusing on risk factors and prevention, detection, and management of hypoglycemia before and while driving.
16177780|NCT01563887|Behavioral|DD.com + MI|Prior to starting and immediately after finishing the DiabetesDriving.com internet intervention, a one hour motivational interview will be conducted with participants. Internet intervention in which participants will complete 6 Cores, or classes over the internet, focusing on risk factors and prevention, detection, and management of hypoglycemia before and while driving.
16177781|NCT01563861|Genetic|RNA analysis|
16177782|NCT01563861|Genetic|gene expression analysis|
16177783|NCT01563861|Other|immunohistochemistry staining method|
16177784|NCT01563861|Other|laboratory biomarker analysis|
16177785|NCT01563848|Procedure|Cryoballoon ablation|After double transseptal puncture, selective PV angiography was performed to identify the PV ostia in 2 projections (right anterior oblique 30º, left anterior oblique 40 º). Baseline potentials of all PVs were recorded with a Lasso catheter (Biosense Webster, Inc., Diamond Bar, California). To assess the exact position of the inflated balloon in relation to the left atrial (LA)-PV junction, contrast medium was injected from the distal lumen of the cryoballon catheter . CBA was performed for a target time of 300 seconds. The right phrenic nerve was constantly paced from the superior caval vein during freezing at the septal PVs. After each freeze, PV conduction was revaluated by the Lasso catheter.
16177786|NCT01563848|Procedure|Implantation of loop recorder|"The RevealXT was implanted in the parasternal area of the chest. The requirement for defining the exact final position was an R-wave amplitude ≥0.4 mV assessed through the Vector Check.
~Patients were provided with the Patient Assistant, a toolthat allows each patient to store the ECG through the implanted device during symptoms: datawere collected in order to analyze heart rhythm during symptomatic events"
16177787|NCT01563848|Procedure|Radiofrequency ablation|Externally-irrigated tip (5-mm tip, Celsius Thermo-Cool, Biosense Webster, Diamond Bar, CA, USA). Temperature-controlled RF delivery was performed with a maximum power output of 50 W and temperature limit of 50 C. The catheter was irrigated using 0.9% saline infusion at a ﬂow rate of 20-40 mL/min during RF delivery and 2 mL/min between applications using a commercially available pump (Cool Flow, Biosense Webster).
16177788|NCT01563835|Drug|bupivacaine, fentanyl|10mL of 0.125% of bupivacaine plus 50 mcg fentanyl, injected through an epidural catheter.
16177789|NCT01563835|Drug|fentanyl|fentanyl IV PCA with boluses 25-50 mcg, 3-6 minute lockout.
16177790|NCT01563822|Biological|Follicular fluid|The intervention is flushing the uterine cavity with 2 ml of clear follicular fluid surrounding mature oocytes after ovum pick-up through an IUI catheter
16177791|NCT01563809|Drug|FSH+LH|75 IU of LH will be given from stimulation day 1
16177792|NCT01563809|Drug|FSH+LH|75 IU of LH will be given from stimulation day 1
16177793|NCT01563783|Procedure|Global Fibroid Ablation (GFA)|GFA is being used for the treatment of symptomatic uterine fibroids
16177794|NCT01563783|Procedure|Abdominal or Laparoscopic Myomectomy|Myomectomy is a procedure in which uterine fibroids are surgically removed from the uterus.
16177795|NCT01563783|Procedure|Uterine Artery Embolization (UAE)|UAE is a minimally invasive surgical procedure used to treat uterine fibroids.
16177796|NCT01563770|Dietary Supplement|Salvia miltiorrhiza extract|3 capsules of 500 mg Salvia miltiorrhiza extract, twice daily for four consecutive weeks
16177797|NCT01563770|Dietary Supplement|Placebo|3 placebo capsules, twice daily for four consecutive weeks
16177798|NCT01563744|Procedure|EGD-assisted administration of colonoscopy prep|Interventional group receive the first 2 liters of prep solution during EGD through the scope channel if colonoscopy expected the following day.
16177799|NCT01563744|Procedure|Control Group received standard prep by oral administration|Control group receive standard oral colonoscopy prep.
16177800|NCT01563731|Drug|all approved antihypertensive drugs; all approved statins|All drugs to be used at doses capable of bringing SBP and LDL-C to targets; only doses approved in each country.
16177801|NCT01563718|Drug|naltrexone for extended release injectable suspension|VIVITROL (naltrexone for extended-release injectable suspension) is supplied as a microsphere formulation of naltrexone for suspension, at a dose of 4cc (380mg of naltrexone base), administered by intramuscular injection to the buttocks (alternating sides monthly) for six months.
16177802|NCT01563705|Procedure|Different motor function tests|Time to rise from a chair, time to go from lying to sitting, time to go from lying to standing, time to cover 10 meters, time to climb 4 steps
16177803|NCT01563705|Procedure|Manual dexterity assessment|Purdue pegboard test
16177804|NCT01563653|Procedure|4 diagnostic tests for surgical success|Q-tip test, Bonney maneuver, TVT maneuver, clip strip test
16177805|NCT01563640|Other|permethrin insecticide|commercial permethrin insecticide impregnation of clothing before transmission season
16177806|NCT01563640|Other|washing|normal washing of school uniforms, without permethrin insecticide impregnation
16177807|NCT01563627|Other|blood sampling for drug resistance biomarkers|comparison of Inflammatory Factors, Immune and Angiogenic in Temporal Lobe Epilepsy
16177808|NCT01563627|Device|Magnetic Resonance Imaging|
16177809|NCT01563614|Radiation|Brain radiotherapy (WBRT alone, SRT/SRS alone or WBRT plus SRT/SRS)|Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.
16177811|NCT01563614|Drug|Liposomal cytarabine|Brain radiotherapy concomitant to lomustine and liposomal cytarabine chemotherapy.
16177812|NCT01563601|Drug|Obatoclax Mesylate, Carboplatine and Etoposide|"Obatoclax Mesylate:
~30 mg fixed dose;administered IV on days 1-3 every 21 days for 6 cycles. Maintenance therapy (optional and only if documented CR or PR) with obatoclax mesylate is administered at the same IV dose on days 1-3 every 21 days until disease progression or death.
~Carboplatin:
~Dose targeted at AUC of 5; administered IV on Day 1 only every 21 days for 6 cycles
~Etoposide:
~100mg/m2 administered IV on Days 1-3 every 21days for 6 cycles"
16177813|NCT01563601|Drug|Carboplatin and Etoposide|"Carboplatin:
~Dose targeted at AUC of 5 administered IV on Day 1 only every 21 days for 6 cycles.
~Etoposide:
~100mg/m2 administered IV on Days 1-3 every 21 days for 6 cycles"
16177814|NCT01563588|Behavioral|dietaty education, physical training, physiotherapy and SPA cares|12 days session of daily physical training, dietary education, physiotherapy and SPA cares in small group (less than 12 women) delivered in hydrothermal centers
16177815|NCT01563575|Other|fast-track implementation process|Undergo fast-track implementation process (WHO-HPH recognition Process), including: baseline data collection, quality plan, implementation for one year, follow-up data collection, revision of quality plan, external site visit and data validation
16177816|NCT01563562|Drug|Bardoxolone Methyl|Oral, Single dose
16177817|NCT01563536|Drug|ABT-267|Tablet
16177818|NCT01563536|Drug|ABT-450|Tablet
16177819|NCT01563536|Drug|ABT-333|Tablet
16177820|NCT01563536|Drug|Ritonavir|Capsule
16177821|NCT01563536|Drug|Ribavirin|Tablet
16177822|NCT01563523|Drug|activated recombinant human factor VII|Standard therapy in conjunction with three single doses of rFVIIa administered over a 3 hour period. Administered once the subject has received 8 units of PRBC
16177823|NCT01563523|Drug|placebo|Standard therapy in conjunction with three single doses of placebo administered over a 3 hour period. Administered once the subject has received 8 units of PRBC
16177824|NCT01563510|Procedure|Laparoscopic operation|Fifty patients with early regional hepatolithiasis were selected and divided into laparoscopic hepatectomy group as described in the detailed description. Total laparoscopic anatomical hepatectomy were performed, combined with cholecystectomy and bile duct exploration when necessary. The intraoperative ultrasound, choledochoscope and hepatic segmental staining were used selectively.
16177825|NCT01563510|Procedure|Open operation|Fifty patients with early regional hepatolithiasis were selected and divided into open group as described in the detailed description. The traditional open regular hepatectomy were performed, combined with cholecystectomy and bile duct exploration when necessary. The intraoperative ultrasound and choledochoscope were used selectively.
16177826|NCT01563497|Drug|PF-05089771|Oral dispersion TS formulation- fasted
16177827|NCT01563497|Drug|PF-05089771|Tablets TS formulation- fasted
16177828|NCT01563497|Drug|PF-05089771|Tablets TS formulation- fed
16177829|NCT01563471|Drug|activated recombinant human factor VII|Subjects will be randomised to one of four treatment sequences. Subjects will receive single bolus i.v. injection of 40, 80 or 160 mcg/kg body weight of trial drug or placebo on each day of the three separate visits
16177830|NCT01563471|Drug|placebo|Subjects will be randomised to one of four treatment sequences. Subjects will receive single bolus i.v. injection of 40, 80 or 160 mcg/kg body weight of trial drug or placebo on each day of the three separate visits
16177831|NCT01563458|Drug|activated recombinant human factor VII|120 mcg/kg into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. 120 mcg/kg single bolus administration at completion of wound closure
16177832|NCT01563458|Drug|activated recombinant human factor VII|60 mcg/kg into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. 60 mcg/kg single bolus administration at completion of wound closure
16177833|NCT01563458|Drug|placebo|Trial drug into the vein (i.v.) bolus injection first administered immediately prior to first skin cut. Repeated every two hours until approx. 30 minutes prior to expected start of the reperfusion of the transplanted liver. Single bolus administration at completion of wound closure
16177834|NCT01563445|Drug|activated recombinant human factor VII|Subjects will be randomised to receive a single intravenous dose of either 5, 20, 40 and 80 mcg/kg body weight. Administered within the first 4 hours after the insult
16177835|NCT01563445|Drug|placebo|Subjects will be randomised to receive a single intravenous dose. Administered within the first 4 hours after the insult
16177836|NCT01563432|Drug|Feburic®|80 mg*1 tablet
16177837|NCT01563432|Drug|TMX-67|40 mg*2 tablets
16177838|NCT01563419|Device|Indicator magnifying window (Izumi Planning Co.)|"IZUMI PLANNING CO,.LTD.Tokyo.Japan
~Material: Polypropylene with polycarbonate lens"
16177839|NCT01563406|Other|15 second scrub|Scrub catheter hubs for 15 seconds before every access.
16177840|NCT01563406|Other|5 second scrub|Scrub catheter hubs for 15 seconds before every access.
16177841|NCT01563406|Drug|3.15% chlorhexidine/70% isopropyl alcohol|3.15% chlorhexidine gluconate in 70% isopropyl alcohol pads will be used to disinfect catheter hubs prior to accessing central venous catheters during half of the study period.
16177842|NCT01563406|Drug|70% isopropyl alcohol|70% isopropyl alcohol pads will be used to disinfect catheter hubs prior to accessing central venous catheters for the other half of the study period.
16177843|NCT01563393|Other|questionnaire STAMP and dietary|Children will undergo a complete evaluation by an investigating dietician and assessment by the STAMP tool in order to determine the extent of the nutritional risk on a numerical scale. According to findings children will get the dietary recommendations.
16177844|NCT01563393|Other|No intervention|The Placebo Comparator arm children got the classic care that practiced in hospitalization
16177845|NCT01563380|Biological|Platelet rich plasma|PRP ready to be injected was supplied in a syringe in a quantity of 8 ml for each knee. The entire procedure was done under complete aseptic precautions. The calcium chloride required for activation was given in a separate syringe in a ratio of 4:1. About 12-16 ml of platelet rich plasma was obtained by this method and it was used for application. To confirm sterility, culture and sensitivity of PRP was performed. Patient's peripheral blood platelet count and the prepared platelet concentrate's platelet count was performed and recorded. Number of tramadol injections given was also noted
16177846|NCT01563367|Drug|Iron isomaltoside 1000 (Monofer®)|All subjects randomised to this group will receive 1000 mg iron isomaltoside 1000 as a single dose infusion administered over 15 minutes
16177847|NCT01563367|Drug|Natriumklorid 9 mg/ml, Fresenius Kabi|All subjects randomised to this group will receive an infusion of 100 ml 0.9% sodium chlorid administered over 15 min.
16177848|NCT01563354|Drug|Pasireotide LAR|60 mg was administered as an intra muscular depot injection once every 28 days starting at Day 1
16177849|NCT01563354|Drug|Everolimus|10 mg tables administered orally once a day
16177850|NCT01563354|Drug|Pasireotide LAR and Everolimus Combination|Pasireotide LAR 60 mg i.m. injected once every 28 days + Everolimus 10 mg p.o. daily
16177851|NCT01563341|Device|Deep brain stimulation|Study will be utilizing multiple brain electrodes simultaneously. The study will require at least two electrodes to be placed in one cerebral hemisphere (one for motor improvement and one for potential cognitive implications).
16177852|NCT01563328|Drug|DTG|50 mg q24h
16177853|NCT01563328|Drug|BCV|800 mg q8h
16177854|NCT01563328|Drug|TVR|750 mg q8h
16177855|NCT01563302|Drug|IONIS-STAT3Rx|Three-hour IV infusions on Cycle 0 Days 1, 3, 5, and weekly three-hour IV infusions in Cycles 1 and beyond, on Days 1, 8, and 15 of each cycle.
16177856|NCT01563289|Drug|Ibuprofen|3 times a day
16177857|NCT01563289|Drug|Placebo|3 times a day
16177858|NCT01563263|Biological|IC43|100 mcg
16177859|NCT01563263|Drug|Placebo|phosphate buffered saline (PBS) solution containing 0,9 % NaCl
16177860|NCT01563250|Device|Point of Care testing|"The investigators will implement 6 months of randomized testing periods, 2 weeks each. During this 2 week block, cardiac biomarkers will be tested at the bedside in the ED using the Triage Cardiac Panel that will test for CK-MB, Myoglobin, and Troponin I.
~Each blood sample that is take for point of care testing will be saved. The plasma from the saved sample will be frozen and the sample will be sent to an off-site testing center for high sensitivity troponin testing.
~All patients will be followed at the 30-day mark and those patients who are discharged home from the ED will be followed within 48 hours as well."
16177861|NCT01563237|Device|MIDI Arrow|Implantation of MIDI Arrow
16177862|NCT01563224|Drug|Baclofen 10mg|Baclofen 10mg single dose po
16177863|NCT01563224|Drug|Baclofen 60mg|Baclofen 60mg single dose po
16177864|NCT01563224|Drug|placebo|placebo
16177865|NCT01563198|Behavioral|Comfort Talk®|Personnel of MRI units will be trained in advanced rapport skills, patient-centered and hypnoidal language, correct use of suggestions and skills of tension diffusion. This will entail 16 hrs class room work, additional on-site post-training support, and access to a post-training support web module resulting in at least 20 hrs training.
16177866|NCT01563185|Drug|800 mg ibuprofen/26.6 mg famotidine|Oral tablet taken three time per day
16177867|NCT01563172|Drug|Sodium fluoride / silica and carbopol, 0.5g|Dentifrice containing 1150 parts per million (ppm) fluoride as sodium fluoride / silica and 0.4% carbopol
16177868|NCT01563172|Drug|Sodium fluoride / silica and carbopol, 1.5g|Dentifrice containing 1150 ppm fluoride as sodium fluoride / silica and 0.4% carbopol
16177869|NCT01563172|Drug|Sodium fluoride / silica and carbopol, 1.5g|Dentifrice containing 250 ppm fluoride as sodium fluoride / silica and 0.4% carbopol
16177870|NCT01563172|Other|Fluoride free dentifrice|A non fluoride dentifrice was given to participants of each arm at washout period
16177871|NCT01563159|Other|Data collection|Each participating centre will be requested to generate a coded list of all stool samples taken during the study period (June 1st 2010- May 31st 2011) and analysed for rotavirus, in children aged ≤5 years.
16177872|NCT01563146|Other|Data collection|Each participating centre will be requested to generate a coded list of all stool samples taken during the study period (June 1st 2006- May 31st 2007) and analysed for rotavirus, in children aged ≤5 years.
16177873|NCT01563133|Procedure|EUS-FNA|Endoscopic ultrasound fine needle aspiration: ultrasound endoscopy of a lesion with aspiration of the lesion fluid through a needle
16177874|NCT01563133|Device|nCLE|needle-based Confocal Laser Endomicroscopy
16177875|NCT01563120|Drug|metformin|metformin up to 2550mg per day.
16177876|NCT01563120|Drug|glybenclamide|glybenclamide up to 20mg per day.
16177877|NCT01563107|Radiation|Total Blood Volume|Using injection of iodinated I-131 tagged human serum albumin nominally 25 micro-Ci of radiation, blood samples are drawn before and 30 minutes after injection.
16177878|NCT01563107|Procedure|Exercise Capacity Test - Bicycle|subjects breath room air through a mouthpiece and exhale the air into a tube that connects to a machine (metabolic cart) that analyzes carbon dioxide and oxygen content, which allows the investigator to calculate the amount of oxygen they are using under resting and exercise conditions.
16177879|NCT01563107|Procedure|Posture Study|Blood pressure and heart rate will be measured while supine and then while standing for up to 30 minutes. Blood will be drawn in each position to measure hormones that regulate blood pressure and blood volume.
16177880|NCT01563081|Drug|Levocetirizine|Clear solution, 0.50 mg levocetirizine dihydrochloride contains in one milliliter of the solution. Levocetirizine oral solution are administered once daily at a dose of 2.5 mL (1.25 mg of levocetirizine) in the morning to infants aged between 6 months and 1 year old
16177881|NCT01563081|Drug|Levocetirizine|Clear solution, 0.50 mg levocetirizine dihydrochloride contains in one milliliter of the solution. Levocetirizine oral solution are administered twice daily at a dose of 2.5 mL (1.25 mg of levocetirizine) in the morning and evening before sleep to infants aged between 1 year and 2 years old
16177882|NCT01563068|Drug|Calcipotriene 0.005% Foam|Topical application applied twice a day for 15 days
16177883|NCT01563055|Drug|chlorambucil, tablets|2mg tablets, chlorambucil dose: 10mg/m2 PO at days 1-7 every 28 days; duration: minimum of 3 cycles until best response or maximum of 12 cycles
16177884|NCT01563055|Drug|ofatumumab (GSK1841157) infusion|iv infusion; dose: cycle 1 300mg day 1 and 1000mg day 8, subsequent cycles: 1000mg at day 1 every 28 days;
16177885|NCT01563042|Drug|Intravenous (IV) single dose|GSK2434735 administered as a single intervenous dose at the beginning of the study
16177886|NCT01563042|Drug|Subcutaneous (SC) single dose|GSK2434735 administered as a single subcutaneous dose at the beginning of the study
16177887|NCT01563029|Drug|Fluticasone Furoate|current asthma medicine
16177888|NCT01563029|Drug|Fluticasone Propionate|Fluticasone propionate
16177889|NCT01563029|Drug|Placebo|placebo
16177892|NCT01563003|Other|Treatment as usual|This condition allows participants to seek out various services. Considering the number of possible treatment options, there is no way to identify or list them.
16177893|NCT01562990|Drug|Rituximab, CMC544, Gemcitabine and Oxaliplatine|"2 cycles of induction of 56 days each, starting with the administration of R-CMC544 on day 1, followed by the administration of R-GEMOX on day 29 and 43.
~2 cycles of consolidation of 56 days each, starting with the administration of R-CMC544 on day 1, followed by the administration of R-GEMOX on day 29 and 43."
16177894|NCT01562977|Drug|Rituximab, Gemcitabine, Oxaliplatin, Dexametasone|until progression or unacceptable toxicity develops, 8 cicles max Rituximab: 375 mg/m2, IV, day 1. Gemcitabine: 1000 mg/m2, IV, day 2. Oxaliplatin: 100 mg/m2, IV, day 2. Dexametasone: 20 mg/day, days 1-3, oral.
16177895|NCT01562964|Behavioral|Hypnotherapy|Ten pain control hypnotherapy session will run for 50-60 minutes each. In the first session a thorough history will be taken of the patient's chest pain history together with both the sensory and affective components of their pain. If there is time, relaxation technique and self-hypnosis will be taught at this visit. In subsequent sessions, various techniques, including techniques that focus on direct suggestions and imagery work, will be applied and taught to the patient. The pain control techniques are all analgesic in nature - focusing on the reduction, but not the total removal of the pain. A small amount of pain is left behind to serve as a reminder that either something is wrong or that the patient needs to take it easy.
16177896|NCT01562964|Behavioral|Supportive therapy|Subjects in the Supportive therapy group will attend the Royal Brompton Hospital weekly for 10 weeks to meet with person of equal status to the hypnotherapist (e.g. a research assistant, not a medical practitioner) trained to provide counseling and support. Visits will last 50-60 min.
16177897|NCT01562951|Drug|ADALIMUMAB|Adalimumab at 160/80 mg and maintained on 40 mg eow until next colonoscopy performed at week 48. If before week 48, an increase of more than 50% is observed in calprotectin and/or hsCRP from baseline, over two consecutive follow up visits 2 weeks apart, the colonoscopy will be performed earlier. If patients have still significant endoscopic lesions, adalimumab or adalimumab placebo will be intensified to 40 mg weekly.
16177898|NCT01562951|Drug|Placebo|PLACEBO at 160/80 mg and maintained on 40 mg eow until next colonoscopy performed at week 48. If before week 48, an increase of more than 50% is observed in calprotectin and/or hsCRP from baseline, over two consecutive follow up visits 2 weeks apart, the colonoscopy will be performed earlier. If patients have still significant endoscopic lesions, adalimumab or adalimumab placebo will be intensified to 40 mg weekly
16177899|NCT01562938|Drug|Placebo|Placebo
16177900|NCT01562938|Drug|MEDI-557|MEDI-557 low-dose
16177901|NCT01562938|Drug|MEDI-557|MEDI-557 high-dose
16177902|NCT01562925|Dietary Supplement|Red wine|Red wine First dosage: 3 ml per kg bodyweight (the evening before contrast medium exposure) Second dosage: 1.5 ml per kg bodyweight (60-120 minutes before contrast medium exposure
16177903|NCT01562925|Dietary Supplement|White wine|White wine First dosage: 3.3 ml per kg bodyweight (the evening before contrast medium exposure) Second dosage: 1.7 ml per kg bodyweight (60-120 minutes before contrast medium exposure
16177904|NCT01562925|Dietary Supplement|Beer|Beer First dosage: 7.8 ml per kg bodyweight (the evening before contrast medium exposure) Second dosage: 3.9 ml per kg bodyweight (60-120 minutes before contrast medium exposure
16177905|NCT01562912|Device|Radiofrequency Ablation Procedure|Application of radiofrequency energy will be delivered during PV antral isolation procedure and should be performed with a standard, open irrigated ablation catheter and a mapping system as the investigator would perform the procedure normally.
16177906|NCT01562912|Device|PVAC Ablation Procedure|Application of radiofrequency energy with the Pulmonary Vein Ablation Catheter(PVAC)to eliminate potentials arising from the pulmonary veins.
16177907|NCT01562899|Drug|MEK162|Supplied as tablets of dosage strength 15 mg in high-density polyethylene bottles with child-resistant closure.
16177908|NCT01562899|Drug|AMG 479|Supplied as sterile liquid for intravenous infusion in vials in boxes. Until April 2013 a frozen formulation with a concentration of 30 mg/ml was used; from May 2013 onwards a refrigerated formulation with a concentration of 70 mg/ml was used.
16177909|NCT01562886|Drug|Rilpivirine|Rilpivirine 26mg
16177910|NCT01562873|Drug|Ruxolitinib|
16177911|NCT01562860|Procedure|Pronator Teres Release|Surgical release of median nerve compression
16177912|NCT01562860|Procedure|dual compression release|Both the carpal tunnel compression and the pronator teres compression will be released on the same day.
16177913|NCT01562860|Procedure|dual compression release|both procedures will be done on the same day
16177914|NCT01562860|Procedure|median nerve release only|only the carpal tunnel compression is released
16177915|NCT01562847|Drug|Nilotinib|Patients will be treated with 800 mg nilotinib daily.
16177916|NCT01562834|Drug|somatropin|Initial dosage 0.5 IU/day, injected subcutaneously (s.c., under the skin) once daily. Dosage will be adjusted monthly depending on clinical safety up to a maximum dose of 3 IU/day. Subjects are treated for six months (randomised trial period) followed by an 12-month open-label trial period with somatropin.
16177917|NCT01562834|Drug|placebo|Initial dosage 0.5 IU/day, injected subcutaneously (s.c., under the skin) once daily. Dosage will be adjusted monthly depending on clinical safety up to a maximum dose of 3 IU/day. Subjects are treated for six months. After treatment in the randomised trial period, placebo will be discontinued.
16177918|NCT01562821|Drug|activated recombinant human factor VII|An initial bolus dose of 50 mcg/kg body weight (BW) followed by 50 mcg/kg BW every second hour until completion of surgery
16177919|NCT01562821|Drug|activated recombinant human factor VII|An initial bolus dose of 100 mcg/kg body weight (BW) followed by 100 mcg/kg BW every second hour until completion of surgery
16177920|NCT01562821|Drug|placebo|An initial placebo bolus dose followed by placebo every second hour until completion of surgery
16177921|NCT01562808|Drug|Aripiprazole|single oral administration of aripiprazole
16177922|NCT01562795|Drug|nonsteroid anti-inflammatory drops|nonsteroid anti-inflammatory drops plus artificial tear substitute
16177923|NCT01562795|Drug|nonsteroid anti-inflammatory drops|nonsteroid anti-inflammatory drops plus artificial tear substitute
16177924|NCT01562795|Drug|corticosteroids|corticosteroids plus artificial tear substitute
16177925|NCT01562795|Drug|artificial tear substitute|artificial tear substitute alone
16178177|NCT01560949|Drug|Gemcitabine|350 mg/m2 by vein every week for 5 doses beginning Day 1 (days 1, 8, 15, 22, 29).
16177926|NCT01562782|Other|Fructose + Glucose Beverage|Consumption of a sweet beverage (Fructose:Glucose 1:1, 3g/kg) over 1/2 hour. Blood sampling will occur before and after consumption of beverage.
16177927|NCT01562756|Other|HVLA-SM|High velocity, low amplitude spinal manipulation
16177928|NCT01562743|Drug|SPM 962|Tansdermal patch
16177929|NCT01562717|Drug|Ibuprofen|3 times a day
16177930|NCT01562717|Drug|Placebo|3 times a day
16177931|NCT01562704|Drug|Paracetamol (drug)|The objective of this study is to evaluate the mechanism of action of paracetamol (versus placebo) in the brain with new assessment tools (functional MRI and test inducing pain by thermal stimulation
16177932|NCT01562691|Procedure|Nasopore|Bilateral nasal packing using Nasopore without airway integrated
16177933|NCT01562691|Procedure|airway integrated Nasopore|post nasoseptoplasty with nasal packing using airway integrated Nasopore
16177934|NCT01562691|Procedure|airway-integrated Vaseline gauze|post nasal septoplasty with packing using airway-integrated Vaseline gauze
16177935|NCT01562678|Drug|Liraglutide|In the experimental arm of this randomized, placebo controlled, cross-over, double-blinded study to assess the effects of liraglutide. Subjects will self-inject Liraglutide once per day for 18 days. Subjects will start the treatment with a dose of 0.6 mg for the first week, then 1.2 mg for the second week and 1.8 mg for 3 days in the third week.
16177936|NCT01562678|Drug|Placebo|In the placebo arm of this randomized, placebo controlled, cross-over, double-blinded study to assess the effects of liraglutide. Subjects will self-inject placebo once per day for 18 days.
16177937|NCT01562652|Device|AposTherapy (All Phases of Step-cycle {APOS} system, APOS-Medical and Sports Technologies Ltd. Herzliya, Israel)|
16177938|NCT01562626|Drug|APS001F|APS001F infusion on Days 1,2,3 of each 28 day cycle.
16177939|NCT01562626|Drug|Flucytosine (5-FC)|oral doses on Days 11-15 and 18-22, each 28 day cycle
16177940|NCT01562626|Drug|10% maltose|10% maltose infusion will be administered on Days 1-5, 8-12, and 15-19, each 28 day cycle.
16177941|NCT01562587|Drug|activated recombinant human factor VII|A single bolus dose is administered. Injected intravenously
16177942|NCT01562587|Drug|activated recombinant human factor VII|A random order of a low/high dose of single dose is administered during two PK-assessment periods separated by a washout period of 48 hours to one month. Injected intravenously
16177943|NCT01562574|Drug|activated recombinant human factor VII|Up to three doses administered after surgery. If bleeding persisted after the third dose of trial product, conventional transfusion would be administered
16177944|NCT01562574|Drug|placebo|Up to three doses administered after surgery. If bleeding persisted after the third dose of trial product, conventional transfusion would be administered
16177945|NCT01562561|Drug|repaglinide|2 mg at each main meal
16177946|NCT01562561|Drug|insulin NPH|Administrated subcutaneously (s.c., under the skin) either at bedtime or twice daily at breakfast and before dinner.
16177947|NCT01562548|Drug|Guaifenesin|high and low dose of Guaifenesin each given twice daily over a 4-day treatment period
16177948|NCT01562548|Drug|Placebo|no active ingredient
16177949|NCT01562535|Other|Pronation|"In this technique the arm is flexed 90 degrees and a gentle pronation is applied to the arm; then the arm is further flexed to 45 degrees until the clinician feels a click in the elbow meaning the re-accommodation of the radial head has been accomplished."
16177950|NCT01562535|Other|Supination|"The affected arm is in a 90 degrees flexion. The clinician will hold the arm by the elbow and then makes a gentle supination of the affected arm and flexion of the elbow until feeling the click and the child is able to move the arm without pain."
16177951|NCT01562522|Other|Psychological counseling|Attendance at 7 group sessions, consisting of 5-6 couples, preceded by an intake consultation. Total intervention time: 16 weeks.
16177952|NCT01562509|Other|Implementation tools|"Professionals receive audit & feedback
~Patients (and clinicians) have access to a website with information tailored to patients with an NHL. This website gives insight into the logistic processes of each diagnostic tool and into the patients' personal care pathway.
~Standardization of diagnostic and evaluative request forms and reports for clinicians.
~Supporting material for standardizing the procedure for multidisciplinary meetings."
16177953|NCT01562509|Other|Standard intervention|Standard intervention consists of audit&feedback
16177954|NCT01562496|Behavioral|Exercise|six-months long exercise intervention on a stationary virtual reality bike, 3-5 times a week, each session lasting 30-45 minutes at a target heart rate (60-85% heart rate reserve).
16177955|NCT01562483|Drug|Tetrahydrocannabinol|The add-on treatment consists of two phases: a step-up phase (day 1-5: 3 mg TID; day 6-10: 5 mg TID), and a stable dose phase (day 11-52: 8 mg TID). The dosage may be tapered to at least 5 mg TID, when 8 mg is not tolerated.
16177956|NCT01562483|Drug|Placebo|Identical to the Namisol arm.
16177957|NCT01562470|Other|Cellulite reduction cream|1/8 tsp cellulite cream will be applied to the thigh twice daily - in the morning and at night, for a period of 16 weeks.
16177958|NCT01562457|Drug|activated recombinant human factor VII|Administered as a single dose. Injected as a slow intravenous injection over 2 minutes (from start to completion of injection)
16177959|NCT01562444|Other|Blood draw|Annual blood draw at years 6 (Visit 18), 7 (Visit 19), 8 (Visit 20), 9 (Visit 21) and 10 (Visit 22)
16177960|NCT01562431|Other|Feed-back|Counselors will receive the results of the completed Signal-checklist completed by participants in the intervention group
16177961|NCT01562418|Behavioral|Ergonomic intervention|Ergonomic intervention, how to sit and work, an d muscle re education with a SurfaceElrctromyograph Biofeedback (SEMG biofeedback)
16177962|NCT01562418|Behavioral|Standard ergonomic intervention|Standard ergonomic intervention , how to sit and work with computers
16177963|NCT01562418|Behavioral|control group|general instructions no intervention
16177968|NCT01562392|Dietary Supplement|berries and vegetables|Daily (5 w) supplementation with specific vegetables and berries
16177969|NCT01562392|Dietary Supplement|control product|Supplementation (daily,5 w) with a control product without berries and vegetables.
16183344|NCT01521559|Procedure|Macular Laser Photocoagulation|
16177970|NCT01562379|Dietary Supplement|Wheat Soy Blend (WSB++)|A wheat formulation containing protein from milk solids and soybeans, essential fats and sugar to provide optimal caloric density, and added vitamins and minerals.
16177971|NCT01562379|Dietary Supplement|Chickpea based complementary food supplement|A chickpea-based complementary food supplement with added milk powder, oil, sugar and added vitamins and minerals.
16177972|NCT01562379|Dietary Supplement|Rice based complementary food supplement|Locally developed rice based complementary food with and added vitamins and minerals.
16177973|NCT01562379|Dietary Supplement|Plumpy Doz|Plumpy Doz is a prepackaged ready-to-use complementary food supplement enriched with added vitamins and minerals.
16177974|NCT01562366|Device|Topaz|Radiofrequency micro debridement with Topaz will be used to treat the gluteal tendons following standard of care procedure
16177975|NCT01562366|Procedure|Iliotibial band release and trochanteric bursectomy|Standard of Care: An iliotibial band release and trochanteric bursectomy will be performed.
16177976|NCT01562340|Other|Pomegranate juice|Pomegranate juice (100 mL) 3 times per week (taken prior to hemodialysis session) for 4 weeks. Followed by 4 week wash-out (no intervention), then crossover to Comparator arm.
16177977|NCT01562340|Other|Pomegranate fruit extract|Pomegranate fruit extract in single capsule (1050 mg) daily by mouth for 4 weeks. Followed by 4 week wash-out (no intervention), then crossover to Comparator arm.
16177978|NCT01562327|Drug|Tocilizumab|Participants received tocilizumab according to individualized physician-prescribed regimens.
16177979|NCT01562314|Drug|GWP42003|1 to 5 50 mg capsules taken BID
16177980|NCT01562314|Drug|Placebo|1 to 5 matching capsules taken BID
16177981|NCT01562301|Drug|Carboplatin|AUC 6 by vein 7 days after Anvirzel administration in a 21 dayc cycle.
16177982|NCT01562301|Drug|Docetaxel|75 mg/m2 by vein 7 days after Anvirzel administration in a 21 day cycle.
16177983|NCT01562301|Drug|Anvirzel|"Starting Cohort Dose: 6 mg/m2 given 3 times a day administered sublingually for a 21 day cycle.
~Expansion Cohort Starting Dose: Maximum tolerated dose from"
16177984|NCT01562301|Behavioral|Questionnaires|Questionnaire completion regarding physical and mental at baseline, 7 days before chemotherapy, day 1 of chemotherapy, day 1 of cycles 2, 3, and 4, and at end of dosing visit.
16177985|NCT01562288|Genetic|DNA analysis|
16177986|NCT01562288|Genetic|gene expression analysis|
16177987|NCT01562288|Genetic|polymerase chain reaction|
16177988|NCT01562288|Other|enzyme-linked immunosorbent assay|
16177989|NCT01562288|Other|laboratory biomarker analysis|
16177990|NCT01562275|Drug|Ipatasertib|multiple doses
16177991|NCT01562275|Drug|Cobimetinib|multiple doses
16177992|NCT01562249|Other|orofacial myofunctional treatment protocol|Once a week for six weeks, the experimental group received a forty minutes session of orofacial myofunctional treatment. A home exercise program was prescribed during each session. The protocol implies in continuous and daily practices - participants were asked to perform exercises at least three times a day. After the first six weeks, the experimental group underwent four sessions for maintenance purposes (two sessions twice a month and two sessions once a month). The total treatment duration was of five months.
16177993|NCT01562249|Other|counseling|The instruction group underwent two supervised forty minutes therapy sessions along the six weeks following surgery. These sessions involved the perception of the stomatognathic system, especially in terms of adequate performance during mastication. Specific exercises were not given and patients were instructed to try to reproduce the adequate pattern of mastication at all meals (i.e. alternated bilateral, with lip closure; with coordination activity of the tongue and mandible).
16177994|NCT01562249|Other|Control Group|As the sEMG test-retest is a critical issue, participants of CG were also tested in two distinct moments (testing occurred with 1 year interval) in order to verify possible changes in the sEMG measurements as a result of retesting.
16177996|NCT01562210|Drug|Olaparib|"Olaparib will be given orally BID for 36 days, administrated with a 12 hour interval. Olaparib will start 2 days before RT and will continue for 2 days after the last RT fraction. Olaparib is also given during the non-radiotherapy days but no maintenance treatment is given after radiotherapy is finished.
~The first cohort will receive Olaparib with a dose of 25mg BID combined with Cisplatin and RT. Thereafter in both with and without cisplatin arms dose escalation will follow to 50mg, 100mg, 200mg, 300mg and 400mg BID."
16177997|NCT01562210|Drug|Cisplatin|6 mg/m2 (5 days/week), 1-1.5 hr before the irradiation (week 1 to 5), given as a 5-minutes intravenous infusion.
16177998|NCT01562210|Radiation|Radiation|A total dose of 66 Gy will be given in 24 fractions from week 1 to 5, excluding the weekends.
16177999|NCT01562197|Drug|axitinib|The starting dose of axitinib (AG-013736) is 5 mg BID administered orally with food.
16178000|NCT01562197|Drug|Axitinib plus Lomustine|Lomustine 90mg/m²
16178001|NCT01562184|Device|Sham tDCS device|Sham tDCS
16178002|NCT01562184|Device|Soterix tDCS device|Active tDCS
16178003|NCT01562171|Other|Cooked Lentils|Consume food items containing one serving of (0.3 cups) of cooked lentils per day for the first 5 days, followed by one serving of (0.6 cups) of cooked lentils per day 5 times per week (equivalent of 3 cups cooked lentils per week) for the remainder of the 12-week schedule.
16178004|NCT01562171|Other|Potato-Based Foods|Control - Consumption of one serving per day of potato-based foods in matrices similar to those containing lentils in the same 12-week schedule, including the smaller serving size for the first 5 days.
16178005|NCT01562158|Procedure|standard therapy|Standard treatment of bleeding
16178006|NCT01562158|Drug|activated recombinant human factor VII|Two days repeated treatment regimen - low dose administered i.v. (into the vein)
16178007|NCT01562158|Drug|activated recombinant human factor VII|Two days repeated treatment regimen - medium dose administered i.v. (into the vein)
16178008|NCT01562158|Drug|activated recombinant human factor VII|Two days repeated treatment regimen - high dose administered i.v. (into the vein)
16178009|NCT01562158|Drug|placebo|Placebo
16178010|NCT01562145|Procedure|Blood sampling|Four mL venous blood samples were collected from all study participants after inclusion
16178011|NCT01562132|Drug|Flucytosine and fluconazole|Flucytosine 100mg/kg/day in 4 divided doses orally for 14 days given in combination with fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily
16183703|NCT01518699|Drug|Moxifloxacin|Moxifloxacin 400mg
16178012|NCT01562132|Drug|Fluconazole|fluconazole 1200mg orally once daily for 14 days, followed by 800mg orally once daily for 8 weeks, followed by 200mg orally once daily
16178013|NCT01562106|Procedure|Fluorescence-guided sentinel lymph node detection|During standard endometrial cancer surgery, ICG dye will be injected into the cervix to identify sentinel lymph nodes in the pelvis.
16178014|NCT01562093|Drug|corticosteroid nasal spray|fluticasone furoate 55 µg (formula containing anhydrous glucose, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, purified water) once daily in each nostril for 3 months
16178015|NCT01562093|Drug|placebo nasal spray|formula containing anhydrous glucose, dispersible cellulose, polysorbate 80, benzalkonium chloride, disodium edetate, and purified water, once daily in each nostril for 3 months
16178016|NCT01562080|Dietary Supplement|Armolipid Plus|one tablet per day during 12 weeks
16178017|NCT01562080|Dietary Supplement|placebo|one tablet per day during 12 weeks
16178018|NCT01562067|Device|ultrasound examination|ultrasound and doppler studies to evaluate size and vascularity of tumor during radiotherapy
16178019|NCT01562041|Drug|Ranolazine 500 mg|Ranolazine 500 mg, oral tablet, b.i.d.
16178020|NCT01562028|Drug|Erlotinib|Patients will be treated with erlotinib, 150 mg p.o., daily
16178021|NCT01562028|Drug|Bevacizumab|Patients will be treated with bevacizumab 15 mg/kg i.v. on day 1 of each 3-week cycle (+/- 3 days)
16178022|NCT01562015|Drug|Ganetespib|Ganetespib 200 mg/m2 administered 1 time per week for the first three weeks of a four week treatment cycle (Days 1, 8, and 15 of the 28 Day treatment cycle).
16178023|NCT01562002|Procedure|Stem Cell with Amniotic Membrane Transplant|Single stem cell expansion in amniotic membrane transplant
16178024|NCT01561989|Dietary Supplement|cholecalciferol|Given PO
16178025|NCT01561989|Other|questionnaire administration|Ancillary studies
16178026|NCT01561989|Biological|trivalent influenza vaccine|Given IM
16178027|NCT01561976|Drug|Metformin hydrochloride prolonged release|1000mg in fasting state
16178028|NCT01561976|Drug|metformin hydrochloride prolonged release|1000mg in fed state
16178029|NCT01561976|Drug|Metformin hydrochloride sustained release/Glimepiride|1000/2mg in fed state
16178030|NCT01561963|Drug|Apremilast|Tablets for oral administration
16178031|NCT01561963|Drug|Rifampin Oral Capsules|Capsules for oral administration
16178032|NCT01561963|Drug|Rifampin IV Solution|Intravenous (IV) solution
16178033|NCT01561950|Drug|eptacog alfa (activated)|If subject is eligible to continue after clopidogrel treatment, three different doses of trial drug is administered i.v. as a slow bolus injection over two to three minutes followed by post-trial biopsies
16178034|NCT01561950|Drug|clopidogrel|Following a baseline biopsy (B0) subjects will receive oral treatment with an initial 300 mg loading dose followed by daily 75 mg doses for at least 3 additional days. If the target platelet inhibition (PI) is achieved, the subject will undergo punch biopsy 1 (B1).
16178035|NCT01561950|Drug|placebo|If subject is eligible to continue after clopidogrel treatment, three different doses of trial drug is administered i.v. as a slow bolus injection over two to three minutes followed by post-trial biopsies
16178036|NCT01561937|Drug|warfarin|After a baseline punch biopsy (B0), warfarin is administered over a period of approximately 7-14 days. Dose is adjusted individually to achieve INR target. Once a stable INR is achieved, a second biopsy (B1) will be performed
16178037|NCT01561937|Drug|eptacog alfa (activated)|If the subject is eligible to continue in trial part B, trial drug will be administered i.v. as a slow bolus injection over 2 to 5 minutes in five different doses followed by two biopsies (B2) and (B3) 15 minutes and 5 hours and 15 minutes, respectively, after trial drug administration
16178038|NCT01561937|Drug|placebo|If the subject is eligible to continue in trial part B, trial drug will be administered i.v. as a slow bolus injection over 2 to 5 minutes in five different doses followed by two biopsies (B2) and (B3) 15 minutes and 5 hours and 15 minutes, respectively, after trial drug administration
16178039|NCT01561924|Drug|eptacog alfa (activated)|Subjects will be called to attend the clinic in a non-bleeding state. Blood samples will be drawn for thromboelastogram profiling and will be in-vitro spiked with different doses of activatated recombinant human factor VII.
16178040|NCT01561911|Drug|Chi Lob 7/4 (A chimeric monoclonal antibody)|3 patients will receive treatment at each dose level. Escalation from one treatment dose level to another will only be permitted once at least 3 patients have completed treatment without any DLTs. Starting weekly dose of Chi Lob 7/4 will be 0.5mg (giving a total dose per patient of 2mg divided over 4 weeks). Subsequent individual, weekly dose levels of 1.6mg, 5mg, 16mg, 50mg and 160mg (resulting in total patient doses of 6.4mg, 20mg, 64mg 200mg and 640mg respectively). Further dose escalation can continue to 240mg and 320mg dose per week (resulting in 960mg and 1280mg. Patients may be treated at a lower or intermediate dose level to define the MTD/BAD.
16178041|NCT01561898|Drug|Paliperidone extended-release (JNS007ER)|Type= range, unit= mg, number= 3-12, form= tablet, route= oral use. JNS007ER within the range of 3, 6, 9 and 12 mg will be orally administered once daily for 48 weeks.
16178042|NCT01561885|Other|Pathway-Based Care|Patients who are randomly allocated to Pathway Care will be treated by the Pathway Clinical Teaching Unit as well as other collaborative healthcare professionals (pharmacists, nurses, health educators, nutritionists, and social workers). The Pathway Care physicians will have access to the Clinical Care Plan on the QuadraMed, which is a detailed, organized, day-to-day treatment plan that includes pre-set orders and medications. Physicians for the patients on Usual Care will not have access to this information, and the collaborative healthcare will only be provided upon consultation.
16178043|NCT01561859|Behavioral|Cognitive Enhancement Therapy|Cognitive Enhancement Therapy (CET) consists of approximately 60 hours of computer-assisted neurocognitive training in attention, memory, and problem-solving; and 45 social-cognitive group sessions that employ in vivo learning experiences to foster the development of social wisdom and success in interpersonal interactions. CET begins with 3 months of weekly 1-hour neurocognitive training in attention, after which patients begin the weekly 1.5-hour social-cognitive groups. Neurocognitive training then proceeds concurrently with the socialcognitive groups.
16178072|NCT01561651|Other|Left Atrial Appendage Occlusion|Surgeon will occlude the left atrial appendage using a suture and/or a surgical stapler or a regulatory approved atrial appendage closure during the patient's cardiac surgery procedure.
16178176|NCT01560949|Drug|5-FU|2000 mg/m2 by vein over 46 hour continuous infusion, on Days 1 - 2 during weeks 1, 3, 5, 7, 9 and 11 for 12 weeks.
16178044|NCT01561859|Behavioral|Enriched Supportive Therapy|"Enriched Supportive Therapy is an individual approach that includes the established principles of supportive therapy previously tested by our group, which are enriched by selected practice principles from the effective Personal Therapy. These manualized supportive therapeutic practices include active listening, correct empathy, appropriate reassurance, basic psychoeducation, including computer-based educational programs, reinforcement of health-promoting initiatives, the provision of case management, and reliance on the advocacy and advice of the therapist in times of crisis."
16178045|NCT01561846|Dietary Supplement|CLA enriched cheese|This study was a 3-week, randomized, double blind, controlled, cross over clinical trial, conducted at the State Hospital Brotzu in Cagliari, Italy. The subjects were randomly assigned to eat 90g/d of the control or enriched cheese for 3 weeks, with a cross over after 3 weeks of washout. The study included 5 visits: 2 screening/baseline visits at weeks -1 and 0, 1 end of intake of 90 g/d of cheese visit at week 3, 1 end of the first wash out visit at week 6, and 1 end of treatment after crossing over visit at week 9. This procedure was subsequently repeated with a cheese intake of 45 g/d
16178046|NCT01561846|Dietary Supplement|CLA enriched cheese|This study was a 3-week, randomized, double blind, controlled, cross over clinical trial, conducted at the State Hospital Brotzu in Cagliari, Italy. The subjects were randomly assigned to eat 90g/d of the control or enriched cheese for 3 weeks, with a cross over after 3 weeks of washout. The study included 5 visits: 2 screening/baseline visits at weeks -1 and 0, 1 end of intake of 90 g/d of cheese visit at week 3, 1 end of the first wash out visit at week 6, and 1 end of treatment after crossing over visit at week 9. This procedure was subsequently repeated with a cheese intake of 45 g/d
16178047|NCT01561833|Drug|Sorafenib|Intrapatient dose reduction to 400 mg once daily and then 400 mg every other day will be allowed depending on the type and severity of toxicity encountered provided that criteria for patient withdrawal from study treatment have not been met.
16178048|NCT01561820|Behavioral|5-month aerobic exercise intervention|The 5-month aerobic exercise intervention is in accordance with the American Heart Association and American College of Sports Medicine physical activity recommendation for optimizing cardiovascular fitness in older adults.Exercise will consist primarily of walking on the treadmill.The goal of the program will be for participants to exercise at a moderate- to high-intensity, defined as 65-80% (ACSM guidelines) of heart rate reserve (HRR), for 30 minutes, 4 days per week.The duration of exercise will progress from 15-20 mins at 50% HRR the 1st week to 30 mins at 65-80% HRR by the end of the 6th week and thereafter.At the start of each session, exercise intensity will be gradually increased to 50% HRR(0.5[HRmax-HRrest]+HRrest)during a 10minute warmup period,and then to the individualized target heart rate training zone for the next 25-30 minutes.Participants will wear a digital heart rate monitoring device for the duration of the training session.
16178049|NCT01561807|Drug|VX-787|
16178050|NCT01561807|Drug|Placebo|
16178051|NCT01561794|Drug|Ciprofloxacin (Cipro, BAYQ3939)|"(1) Community-acquired pneumonia (CAP): 400 mg BID, i.e. every 12 ± 1 hours (For those with Ccr > 60 mL/min, 400 mg TID, i.e. every 8 ± 1 hours may be considered at the discretion of investigators) for 7 to 14 days.
~2) Hospital-acquired pneumonia (HAP): For the patient with Ccr > 60 mL/min, 400 mg TID, i.e. every 8 ± 1hours for 7 to 14 days For the patient with 30 ≤Ccr ≤60 mL/min, 400 mg BID, i.e. every 12 ± 1hours for 7 to 14 days 3) Secondary infection of chronic respiratory disease 400 mg BID, i.e. every 12 ± 1 hours (For those with of Ccr > 60 mL/min, 400 mg TID, i.e. every 8 ± 1 hours may be considered at the discretion of investigators) for 7 to 14 days."
16178052|NCT01561781|Drug|Digoxin|Oral tablets 0.25mg, single dose
16178053|NCT01561781|Drug|Vandetanib|Oral tablets, 300 mg, single dose
16178054|NCT01561768|Biological|Novavax Quadrivalent vaccine|Quadrivalent VLP vaccine: low dose; intramuscular injection, deltoid
16178055|NCT01561768|Biological|Novavax Quadrivalent vaccine|Quadrivalent VLP vaccine: medium dose; intramuscular injection, deltoid
16178056|NCT01561768|Biological|Novavax Quadrivalent vaccine|Quadrivalent VLP vaccine: high dose; intramuscular injection, deltoid
16178057|NCT01561768|Biological|Novavax Trivalent vaccine|Trivalent Dose; intramuscular injection, deltoid
16178058|NCT01561768|Biological|cTIV|Preconfigured dose; intramuscular injection, deltoid
16178059|NCT01561755|Drug|Intravenous Immunoglobulin|Intravenous Immunoglobulin - 2gr/kg over 2 days of Privigen®
16178060|NCT01561755|Drug|Placebo|Placebo - 2gr/kg over 2 days of saline
16178061|NCT01561742|Drug|Minocycline|Minocycline will be given orally at 200 mg a day for 4 months
16178062|NCT01561742|Drug|Placebo|EquivalentPlacebo will be given
16178063|NCT01561729|Device|RightSpot pH Indicator|The RightSpot pH Indicator device is used to confirm proper placement of all types of gastric tubes used for gastric rest, suction, or medicating/feeding by measuring the pH of stomach aspirate. This device is intended for 1 (one) SINGLE USE. The probability of proper placement is higher when the pH is less than or equal to 4.5 and if aspirate has a typical gastric fluid appearance (grassy green, brown, colorless- with possible shreds of off-white mucus or sediment).
16178064|NCT01561729|Radiation|Chest radiograph|Chest radiograph will be taken after tube placement to verify proper positioning of the nasogastric or orogastric tube.
16178065|NCT01561716|Device|Wii Fit|This is a randomized, crossover study to evaluate the energy expenditure associated with Wii Fit games. After the baseline resting energy expenditure assessment, each participant complete the following physical activities on separate days in a random order, (1) 30-minute Wii Fit Aerobics Free Run, (2) 3 bouts of Wii Fit Aerobics (Advanced Step, Super Hula Hoop, and Rhythm Boxing in a random order) each lasting 10 minutes, and (3) 30-minute treadmill running/walking.
16178066|NCT01561703|Drug|Antibiotic|One of seven antibiotics (amoxicillin; amoxicillin/clavulanate potassium; azithromycin; cefaclor; cephalexin; cefdinir; or clindamycin) will be given at standard dosage that may be used for 7-10 days following surgery .
16178067|NCT01561690|Drug|ARRY-502, CRTh2 antagonist; oral|multiple dose, single schedule
16178068|NCT01561690|Drug|Placebo; oral|matching placebo
16178069|NCT01561677|Device|Continuous Positive Airway pressure-RESPIRONICS|obstructive sleep apnea syndrome survival ischemic stroke continuous positive airway pressure handicap
16178070|NCT01561677|Device|Sham Continuous Positive Airway pressure-RESPIRONICS|inefficient Continuous Positivie Airway pressure
16178071|NCT01561664|Other|muscle and fat biopsy|muscle and fat biopsy
16178073|NCT01561638|Procedure|Conventional Radiofrequency|pulsed radiofrequency will delivered at 45V for 2 cycles of 120 seconds(temperature not more than 42degree centigrade)
16178074|NCT01561638|Procedure|Pulsed Dose Radiofrequency|pulsed dose pulsed radiofrequency,we will set the machine to give 480 pulses each pulse of 45 volts for 20 milliseconds duration with a temperature limit of 42 degree centigrade)
16178075|NCT01561638|Procedure|Sham|will receive puncture for 4 minutes
16178076|NCT01561625|Other|exercise|resistance training exercise, 1 session, 3 exercises, 80% of max
16178077|NCT01561612|Behavioral|Breastfeeding promotion and support|Breastfeeding promotion and support according to the World Health Organization's Baby Friendly Hospital Initiative
16178078|NCT01561599|Drug|BB3|Daily intravenous administration of 2mg/kg for 4 days
16178079|NCT01561599|Drug|Normal Saline|Daily intravenous administration for four (4) days. The volume of normal saline will vary by estimated weight.
16178080|NCT01561586|Drug|Weekly cisplatin with RT|"Cisplatin 40mg/m2 IV Weekly For 6 Cycles.(The 6th cycle of cisplatin may be omitted if external beam radiation therapy has been completed) Cisplatin may be diluted and administered per established institutional guidelines. For general suggestion, 40 mg/ m2 of cisplatin may be diluted in 250 ml 0.9% sodium chloride and administered over one or two hours.
~Cisplatin will be given on the first day of external RT (Day 1), preferably, and must be given prior to radiation treatment on that day
~External beam RT will be followed by intracavitary brachytherapy. The total elapsed time for completion of external beam to the whole pelvis, intracavitary BT, and parametrial / nodal RT shall not exceed eight weeks (56 days)"
16178081|NCT01561586|Drug|Tri-weekly cisplatin with RT|"Tri-weekly cisplatin 75mg/m2 three cycles concurrent to radiation therapy
~Cisplatin may be diluted and administered per established institutional guidelines. For general suggestion, 75 mg/m2 of cisplatin may be diluted in 500 ml 0.9% sodium chloride and administered over one or two hours (rate of 1 mg of cisplatin per minute).
~Cisplatin will be given on the first day of external RT (Day 1), preferably, and must be given prior to radiation treatment on that day.
~External beam RT will be followed by intracavitary brachytherapy. The total elapsed time for completion of external beam to the whole pelvis, intracavitary BT, and parametrial / nodal RT shall not exceed eight weeks (56 days)"
16178082|NCT01561573|Device|Point of care ultrasound|A bedside ultrasound machine will be used to image the colles fracture during the fracture reduction process.
16178083|NCT01561560|Device|Delefilcon A contact lenses|CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two
16178084|NCT01561560|Device|Narafilcon A contact lenses|CE-marked, silicone hydrogel, soft contact lenses for daily wear, daily disposable use, worn bilaterally for two weeks in either Period One or Period Two
16178085|NCT01561547|Behavioral|Kangaroo Mother Care|Infant wearing only diaper is held in skin-to-skin contact with mother with flannel blanket around both mother and infant. removal.
16178086|NCT01561547|Dietary Supplement|Sucrose|24% sucrose in volumes between .05 to 2 ml depending on weight of the infant, is inserted by dropper into the infants mouth two minutes before and/or during the painful procedure with up to 3 doses.
16178087|NCT01561521|Drug|AKF-1|1 drop AKF-1 0.025% in each eye at 2 separate times during a 14 day period
16178088|NCT01561521|Drug|AKF-1|1 drop AKF-1 0.035% in each eye at 2 separate times during a 14 day period
16178089|NCT01561521|Drug|AKF-1|1 drop 0% in each eye at 2 separate times during a 14 day period
16178090|NCT01561508|Drug|gamma-amino-butyric acid|gamma-amino butyric acid will be administered orally at a dose of 80mg/kg/day divided BID for one year.
16178091|NCT01561508|Dietary Supplement|Xylitol|The placebo group will be provided Xylitol powder dosed per body weight. Participants will be instructed to take powder orally twice a day for one year.
16178092|NCT01561495|Radiation|Proton Therapy|
16178093|NCT01561482|Drug|Metformin|Metformin treatment will be started at 500 mg twice daily (dose level -2), in order to minimize gastrointestinal discomfort and, if no gastrointestinal toxicity grade greater than 1, will be increased to 500 mg with breakfast/1000 mg at bedtime (dose level -1) 4 days later (+/- 1 day allowed). If no gastrointestinal toxicity grade greater than 1, it will be increased to 1000 mg twice daily (dose level 0) 10 days later (+/- 2 days allowed), which is the target dose for the remainder of the study. If gastrointestinal toxicity grade greater than 1 occurs during these first 4 weeks, the subject will be evaluated every 2 weeks until resolution of toxicity to grade less than or equal to 1 and, then, the metformin dose will be increased to the next dose level.
16178094|NCT01561482|Drug|Simvastatin|The simvastatin dose at treatment initiation will be 20 mg once daily (dose level -1), taken at bedtime for 2 weeks. After these 2 weeks, the subject will have blood work and, if no AST/ALT/CPK elevation grade greater than 1, will be escalated to 40 mg once daily (dose level 0), taken at bedtime. If AST or ALT or CPK elevation grade greater than 1 during the first 2 weeks, the subject will be evaluated every 2 weeks until resolution of toxicity to grade less than or equal to 1, and then the simvastatin dose will be increased to dose level 0.
16178095|NCT01561469|Drug|Linezolid|Patients with documented MRSA hospital-acquired or ventilator-associated pneumonia treated with linezolid according to routine medical care.
16178096|NCT01561469|Drug|Vancomycin|Patients with documented MRSA hospital-acquired or ventilator-associated pneumonia treated with vancomycin according to routine medical care.
16178097|NCT01561456|Drug|AXL1717|AXL1717 administered as oral suspension at 400 mg twice daily for 21 days per cycle; i.e. daily for up to four cycles
16178098|NCT01561456|Drug|Docetaxel|Docetaxel administered as a standard treatment (75 mg/m2 IV infusion over 1 hour) once every three weeks throughout the 4-cycle study
16178099|NCT01561430|Drug|LY2886721|
16178100|NCT01561430|Drug|Placebo|
16178101|NCT01561417|Drug|activated recombinant human factor VII|One single dose administration, injected i.v. (into the vein)
16178102|NCT01561417|Drug|activated recombinant human factor VII|One single dose administration, injected i.v. (into the vein)
16178103|NCT01561404|Drug|Everolimus|In patients that change of immunosuppressive therapy from calcineurin inhibitor (CNI)(tacrolimus or cyclosporine) to m-TOR (everolimus)has been clinically indicated, check if there is an increase in physical exercise capacity.
16178104|NCT01561391|Drug|activated recombinant human factor VII|Infused continuously at 50 mcg/kg/hr through Day 5 then at 25 mcg/kg/hr on Days 6 to10.
16178105|NCT01561391|Drug|activated recombinant human factor VII|Injected every 2 hours during surgery through Day 5, then every 4 hours for Days 6 to 10.
16178130|NCT01561196|Procedure|arterial catheterisation|arterial catheterisation in Arterial Radialis
16178106|NCT01561391|Other|factor IX|Patients with haemophilia A or B without inhibitors undergoing similar surgery were treated in accordance with local standard of care per physician's orders.
16178107|NCT01561391|Drug|factor VIII|Patients with haemophilia A or B without inhibitors undergoing similar surgery were treated in accordance with local standard of care per physician's orders.
16178108|NCT01561378|Drug|Aspart insulin|40 IU of aspart insulin (200 microliters per nostril) will be administered intranasally using an intranasal mucosal atomizer device within 2 hours prior to surgery, and then four times a day for 7 days or until hospital discharge (whichever occurs first)
16178109|NCT01561378|Drug|Normal saline|200 microliters of normal saline will be administered per nostril using an intranasal mucosal atomizer device within 2 hours prior to surgery, and then four times a day for 7 days or until hospital discharge (whichever occurs first)
16178110|NCT01561378|Device|Intranasal mucosal atomizer device|Insulin and placebo will be drawn into identical syringes. Nurses will administer the insulin or placebo by connecting the mucosal atomizer device (MAD) to the syringe, placing the MAD tip in the nostril and compressing the syringe plunger to spray atomized solution into the nasal cavity.
16178111|NCT01561365|Behavioral|Ottawa ankle rules|Ottawa ankle rules implementation
16178112|NCT01561352|Drug|activated recombinant human factor VII|If non-responding haemorrhagic cystitis to 24-hour trial of conventional therapy, 80 mcg/kg is administered i.v. for the first dose. If necessary, two additional doses of 120 mcg/kg can be administered i.v.
16178113|NCT01561326|Behavioral|Cognitive-affective barriers counseling|Culturally-relevant/sensitive barrier-specific messages drawn from a pre-developed library designed to counsel individuals regarding their specific barriers to adherence, e.g., by increasing risk-related knowledge, providing accurate outcome and self-efficacy expectancies, addressing health-related values and goals, moderating risk-related affect, or offering active plans and strategies to assist with self-regulation
16178114|NCT01561326|Behavioral|Cognitive-affective barriers counseling via brochure|Culturally-relevant/sensitive barrier-specific messages drawn from a pre-developed library designed to counsel individuals regarding their specific barriers to adherence via brochure, e.g., by increasing risk-related knowledge, providing accurate outcome and self-efficacy expectancies, addressing health-related values and goals, moderating risk-related affect, or offering active plans and strategies to assist with self-regulation
16178115|NCT01561326|Behavioral|standard care|Cognitive-affective barriers (CAB) assessment delivered via phone; receipt of a notification letter from physician regarding abnormal Pap test result, need to undergo colposcopy, appointment date and clinic contact numbers; telephone confirmation and post-card appointment reminder
16178116|NCT01561313|Biological|Adalimumab|Subcutaneously 40 mg every other week (EOW) or every week (EW) (as dosing requires)
16178117|NCT01561300|Other|Nutrition intervention study with a black tea extract|"Tea extract: 1800 mg/day standardized Brooke Bond black tea extract equivalent to 400 mg flavonoids dissolved in 240 ml hot water.
~Products will be consumed for 8 days. On measurement days tea will be given to the subjects as a single acute dose and 2 grams of sugar will be added.
~On day 2-7 subjects will consume 3 cups or tea, each prepared with 800 mg product in 80 ml of boiling water and sugar added to subject's taste. First cup of tea will be taken as morning tea, 2nd at breakfast and 3rd in the evening. No milk will be added."
16178118|NCT01561300|Other|Nutrition intervention study with a control|"Control: 1800 mg/day of a powder that gives a flavoured beverage with a color similar to black tea dissolved in 240 ml hot water.
~Products will be consumed for 8 days. On measurement days control will be given to the subjects as a single acute dose and 2 grams of sugar will be added.
~On day 2-7 subjects will consume 3 cups of control, each prepared with 800 mg product in 80 ml of boiling water and sugar added to subject's taste. First cup of tea will be taken as morning tea, 2nd at breakfast and 3rd in the evening. No milk will be added."
16178119|NCT01561287|Procedure|Dermal Autograft|Patients in the dermal autograft group will undergo harvest of a dermal autograft from the lower abdomen at the time of mastectomy, which will be used to cover the lower pole of the tissue expander.
16178120|NCT01561287|Procedure|AlloDerm|The acellular dermal matrix used in our study is AlloDerm (LifeCell Corp., Branchburg, N.J.) The AlloDerm group will consist of patients without a suitable abdomen for autografting and those who declined the dermal autograft procedure. Patients in the dermal allograft group will have placement of AlloDerm over the lower pole of the tissue expander. Patients with a lower abdominal scar and sufficient abdominal laxity for autograft harvest will be offered this technique.
16178121|NCT01561274|Drug|2 ml bupivacaine|2 ml bupivacaine
16178122|NCT01561274|Drug|1.5 ml bupivicaine.|1.5 ml bupivicaine.
16178123|NCT01561261|Other|Continuous tissue perfusion monitoring by near-infrared spectroscopy (NIRS) and intramuscular pressure (IMP)|Continuous monitoring of tissue perfusion using NIRS in all 4 leg muscle compartments and IMP via indwelling catheters in anterior and deep posterior compartments. These measures will not provided in real time to treating physicians. All clinical care, including the diagnosis of ACS, will be according to the current standard-of-care practiced at each institution, Clinicians may use the indwelling IMP monitor to obtain up to 2 discrete measures of IMP if they encounter a clinical situation in which they would normally measure IMP as an adjunct in their normal standard-of-care for the monitoring and diagnosis of compartment syndrome. Patients who undergo fasciotomy will also have NIRS and IMP values recorded from all 4 leg compartments immediately before and after fasciotomy.
16178124|NCT01561248|Drug|polyethylene glycol solution for daily bowel lavage.|At admission,patients with severe EHEC infection received two liters of orally administered electrolytes- balanced polyethylene glycol solution for bowel lavage. Treatment was continued with one liter of polyethylene glycol solution daily for repetitive intestinal lavage during the clinical course.
16178125|NCT01561235|Other|Dose-reponse effect of protein on appetite and appetite-regulating hormones|3-arm meal study for investigation of the mechanisms responsible for the satiating effects of protein in three isocaloric test meals with a protein content of 14, 25 or 50 E% protein. A possible 4-h dose-response effect of protein was investigated on a number of appetite-regulating hormones/peptides, together with changes in subjective appetite sensations and sensory desires were evaluated and ad libitum energy intake.
16178126|NCT01561222|Drug|Calcitriol|0.25 ug per day for one year
16178127|NCT01561222|Drug|placebo|one pill per day
16178128|NCT01561209|Drug|Amitryptiline|Amitryptiline 5 mg before bedtime for 2 months
16178129|NCT01561209|Drug|Placebo|"Placebo pill
~1 before bedtime"
16184223|NCT01514929|Drug|Moxifloxacin|400mg oral pill given once
16178131|NCT01561183|Procedure|Indirect pulp capping (IPC)|"Procedure: IPC
~The IPC will be performed as follow:
~Anesthesia
~isolation the tooth
~access to the lesion
~incomplete removal of carious tissue from the cavity walls
~indirect pulp capping with ≈2 mm layer calcium enriched mixture cement
~permanent filling with sandwich technique"
16178132|NCT01561183|Procedure|Direct pulp capping (DPC)|"Procedure: DPC
~The DPC will be performed as follow:
~Anesthesia
~isolation the tooth
~access to the lesion
~complete removal of carious tissue from the cavity walls result in pulp exposure
~preparation of clot-free pulpal mound
~direct pulp capping with ≈2 mm layer calcium enriched mixture cement
~permanent filling with sandwich technique"
16178133|NCT01561183|Procedure|Miniature pulpotomy (MP)|"Procedure: MP
~The MP will be performed as follow:
~Anesthesia
~isolation the tooth
~access to the lesion
~complete removal of carious tissue from the cavity walls result in pulp exposure
~intentionally removal of pulp horn (≈1 mm)
~preparation of clot-free pulpal mound
~direct pulp capping with ≈2 mm layer calcium enriched mixture cement
~permanent filling with sandwich technique"
16178134|NCT01561183|Procedure|Full pulpotomy (FP)|"Procedure: FP
~The FP will be performed as follow:
~Anesthesia
~isolation the tooth
~access to the lesion
~complete removal of carious tissue from the cavity walls result in pulp exposure
~pulpotomy
~preparation of clot-free pulpal mound
~direct pulp capping with ≈2 mm layer calcium enriched mixture cement
~permanent filling with sandwich technique"
16178135|NCT01561170|Device|Active Pulsed Electro-Magnetic Field (PEMF)|One group of patients receive active devices. Both patients and investigator are blinded.
16178136|NCT01561170|Device|Placebo Pulsed Electro-Magnetic Field (PEMF)|One group of patients receive placebo devices. Both patients and investigator are blinded.
16178137|NCT01561131|Dietary Supplement|Whey protein|45g protein/d; Dosage 3x15g protein daily
16178138|NCT01561131|Dietary Supplement|Whey protein enriched with calcium|45g protein/d + 1000mg calcium/d; dosage: 15g protein + 333mg calcium x 3 daily
16178139|NCT01561131|Dietary Supplement|Soy protein|45g soy protein/d; dosage 15g soy protein x 3 daily
16178140|NCT01561131|Dietary Supplement|Maltodextrin|48g carbohydrate/d; dosage: 16g carbohydrate x 3 daily
16178141|NCT01561118|Other|Bicycle-Ergometer Training|"Performance adapted, hence individualised three times weekly bicycle-ergometer training during hemodialysis. Each training will last 30 to 50 minutes with 70-80% of the patient specific maximum workload over 12 weeks (36 training sessions - first part of the study compared to no intervention).
~In the second part of the study both groups get the opportunity for another 12 weeks of individualised three times weekly bicycle-ergometer training during hemodialysis."
16178142|NCT01561105|Other|IMPACT|IMPACT is a collaborative care management program for late-life depression
16178143|NCT01561092|Drug|Escitalopram|5 or 10 mg escitalopram tablets administered orally once daily
16178144|NCT01561092|Drug|Placebo|Tablets
16178145|NCT01561079|Drug|Buprenorphine|Daily sublingual buprenorphine treatment of pregnant, opioid dependent women from up to 34 weeks gestation through one month of infant age.
16178146|NCT01561066|Procedure|Autologous platelet-rich fibrin glue (PRFG)|"Preparation of autologous platelet-rich fibrin glues (PRFG) The platelet-rich plasma (PRP) was separated by centrifugation from 300-400 ml whole blood for 6 min at 1000g, 22°C twice, keeping most of the platelets (50%-60%) in the plasma fraction. For 50g PRP from each patient, with citric acid (2.84mM) lowering and NaHCO3 (75mM) adjusting the PH value, thrombin solution was produced. On the other hand, cryoprecipitate was produced from the rest of the plasma. Frozen at -80°C for at least 6h and then thawed at 4°C, PRP went through centrifugation at 4000rpm/min for 5min.
~PRFG application The application of the glues through the external opening of the fistula was controlled by the drainage tube through a double-syringe system with distal mixing device. The distance was based on fistulography to assure total occlusion of the internal hole. After the FG was instilled, any redundant glue was removed from the external openings."
16178147|NCT01561066|Drug|Octreotide|subcutaneous injection, 0.3mg/8h until enteral nutrition resolution
16178148|NCT01561053|Biological|Albumin 5%|Therapeutic plasma exchange with human albumin 5%
16178149|NCT01561053|Biological|Albumin 20%|Low volume plasma exchange with human albumin 5%
16178150|NCT01561053|Biological|Immunoglobulin|Intravenous human immunoglobulin 5%
16178151|NCT01561040|Dietary Supplement|Omega 3, Vitamins A, D3 and E|omega 3 1480 mg vitamin A 1,000 IU vitamin D3 2,000 IU vitamin E 60 IU
16178152|NCT01561027|Drug|CNV1014802|Administered as specified in treatment arm.
16178153|NCT01561027|Drug|Placebo|Administered as specified in treatment arm
16178154|NCT01561014|Drug|erlotinib hydrochloride|Given PO
16178155|NCT01561014|Drug|oxaliplatin|Given IV
16178156|NCT01561014|Drug|fluorouracil|Given IV
16178157|NCT01561014|Radiation|radiation therapy|Undergo radiotherapy
16178158|NCT01561014|Procedure|conventional surgery|Undergo surgical resection
16178159|NCT01561014|Other|immunohistochemistry staining method|Correlative study
16178160|NCT01561014|Procedure|positron emission tomography|Correlative study
16178161|NCT01561014|Procedure|computed tomography|Correlative study
16178162|NCT01561014|Procedure|laboratory biomarker analysis|Correlative study
16178163|NCT01561014|Genetic|gene expression analysis|Correlative study
16178164|NCT01561014|Radiation|fludeoxyglucose F 18|Undergo F18 PET and CT scan
16178165|NCT01561001|Device|SENSIMED Triggerfish®|Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours.
16178166|NCT01560988|Drug|Borage and Echium Seed Oils|4.0 g/day borage seed oil and 7.0 g/day echium seed oil. Pills will be taken three times per day for six weeks.
16178167|NCT01560988|Dietary Supplement|Corn oil pills|Corn oils pills will be taken three times per day for six weeks.
16178168|NCT01560975|Device|SENSIMED Triggerfish®|Portable investigational device using a contact lens sensor that monitors the IOP fluctuation continuously over 24-hours
16178169|NCT01560962|Drug|povidone iodine|over the counter (OTC) 5% povidone iodine (PI)
16178170|NCT01560962|Other|No Intervention|
16178171|NCT01560962|Drug|Azithromycin|
16178172|NCT01560962|Drug|tobramycin-dexmethasone|
16178173|NCT01560962|Other|warm soaked eyelid wash|
16178174|NCT01560949|Drug|Oxaliplatin|75 mg/m2 by vein on Day 1 of weeks 1, 3, 5, 7, 9 and 11 for 12 weeks.
16178175|NCT01560949|Drug|Irinotecan|150 mg/m2 by vein on Day 1 of weeks 1, 3, 5, 7, 9 and 11 for 12 weeks.
16178178|NCT01560949|Radiation|Radiation Therapy|External beam radiation therapy delivered 5 days/week +/- 2 days over 5.5 weeks with 18-MeV photons. 3D conformal RT, a total dose of 50.4 Gy 1.8 Gy/fraction (28 fractions).
16178179|NCT01560923|Biological|Indoximod|Given twice daily (1200 mg total) by mouth for 6 months.
16178180|NCT01560923|Biological|Sipuleucel-T|Sipuleucel-T will be administered as standard of care. Given by infusion over 60 minutes at Week 0, 2 and 4. Patients will undergo leukapheresis at weeks 0, 2, and 4 with sipuleucel-T infused 3 days later (i.e. Monday/Thursday; Tuesday/Friday).
16178181|NCT01560923|Other|Placebo|Given in same manner as Indoximod; 1200 mg per day by mouth.
16178182|NCT01560897|Drug|Oral C13|Ingestion of C13 and follow up of the ureogenesis
16178183|NCT01560884|Drug|Renazorb 1500 mg/day|Six subjects will be randomly assigned to receive SPI-014 1500 mg/day dose and 2 subjects to receive placebo
16178184|NCT01560884|Drug|Renazorb 3000 mg/day|Six subjects will be randomly assigned to receive SPI-014 3000 mg/day dose and 2 subjects to receive placebo
16178185|NCT01560884|Drug|Renazorb 4500 mg/day|Six subjects will be randomly assigned to receive SPI-014 4500 mg/day dose and 2 subjects to receive placebo
16178186|NCT01560884|Drug|Renazorb 6000 mg/day|Six subjects will be randomly assigned to receive SPI-014 6000 mg/day dose and 2 subjects to receive placebo
16178187|NCT01560871|Behavioral|High-intensity IMT plus walking|"The IMT intensity was set at 60% of PImax which was reassessed weekly. Frequency: 5x/week; 1x/day preferred. 6 Interval Levels: (6 efforts at each level): (1) 60s rest interval; (2) 45s rest interval; (3) 30s rest interval; (4) 15s rest interval; (5)10s rest interval; (6) 5s rest interval, trained to exhaustion.
~For the walking program, it was the same as the one for the control group."
16178188|NCT01560871|Behavioral|Low-intensity IMT plus walking|"The IMT training was 3 sets of 10 repetitions, or when the participant felt tired. Participants returned to our facility every week to reassess PImax.
~For the walking program, each participant was given a pedometer and a heart rate monitor to track daily step counts and heart rate. The walking program consisted of walking every day at an intensity of somewhat hard to hard on the Borg's Rating of Perceived Exertion scale. Participants began at least 10 to 15 minutes, once to twice a day, for 7 days a week, and eventually progressed to 45-50 minutes a day by the end of the six weeks, if they could tolerate."
16178189|NCT01560845|Procedure|Autologous bone marrow stem cells infusion （ABMSCi） plus abdominal portal hypertension surgery|Immediately after the harvest of ABMSC, the modified Sugiura procedure was performed for the patients who were assigned to the study group. The time of ABMSC separation and purification was 2.5-3 hours which had to be completed before the conclusion of portal hypertension surgery (3-3.5 hours). ABMSC was infused into proper hepatic artery through right gastric artery during the portal hypertension surgery
16178190|NCT01560845|Procedure|open abdominal portal hypertension surgery|the modified Sugiura procedure was performed for the patients
16178191|NCT01560819|Drug|Gut Microbial Transplantation|Each participant received Gut Microbial Transplantation (GMT) as retention enema over a period of 1 hour (60mL enema every 15 minutes) daily for 5 days. Although 240mL of GMT solution was prepared for each participant, the final administered dose was dependent on the subject's comfort and willingness to proceed with the next enema, which was assessed after each enema infusion. Subjects were monitored for 30 minutes after GMT for any immediate adverse events and discharged.
16178192|NCT01560806|Other|Commune Hypertension Management|"People with high blood pressure will be invited to join the management programme, with monthly check-up, delivery of multi anti-hypertensive drugs and lifestyle consultation.
~Antihypertensive drugs delivered to local patients included (1) low-dose hypothiazide diuresis, (2) calcium channel blocker and (3) ACEI"
16178193|NCT01560793|Biological|VAX161 [STF2.HA5 H5N1]|dose escalating, 2 intramuscular doses given 21 days apart
16178194|NCT01560780|Drug|Prasugrel|one 10 mg tablet by mouth daily
16178195|NCT01560780|Drug|Placebo|placebo similar in appearance to prasugrel
16178196|NCT01560767|Drug|Femoral Nerve Block|Under aseptic conditions, the femoral artery will be palpated immediately below the inguinal ligament and nerve stimulation will be used to identify the femoral nerve just lateral to the artery. Once the femoral nerve has been identified the block may be performed in the routine manner, using 30 ml of levobupivacaine 0.25%. The precise technique used will be noted on trial documentation.
16178197|NCT01560767|Drug|peri-articular infiltration|The peri-articular infiltration of multimodal agents will consist of 150 mg of levobupivacaine, 10 mg morphine and 30mg ketorolac diluted in 0.9% saline to make a volume 100 ml. (0.5ml 1:1000 adrenaline will be added to the mixture to reduce blood loss after the operation) Fifty ml of the mixture will be injected into the posterior, medial and lateral soft-tissues just prior to implantation of the TKA components. Care will be taken to avoid excessive infiltration in the area of the common peroneal nerve. Then, while the cement is curing, the anterior soft-tissues including the quadriceps mechanism, the retinacular tissues and the subcuticular tissues will be infiltrated with the remaining 50 ml of peri-articular injection.
16178198|NCT01560754|Drug|nicotine transdermal patch|Transdermal patches containing 7 or 14 mg nicotine or placebo with subjects titrating up until reaching their highest tolerated dose of 7 to 28mg/day.
16178199|NCT01560741|Device|Telemonitoring tools|Patients will go home with telemedicine tools to monitor efficacy and compliance of non-invasive home mechanical ventilation
16178200|NCT01560741|Device|Usual Care|The assessment of efficacy and compliance will be monitor at the end of third month. This is the date of the scheduled hospital visit.
16178201|NCT01560728|Behavioral|Trauma-Focused Cognitive Behavioral Therapy|Individual psychotherapeutic approach occurring once per week for 12 to 20 weeks
16178202|NCT01560715|Biological|intravitreal injection of autologous bone marrow stem cells|One intravitreal injection of a 0.1-ml cell suspension containing around 10x106 bone marrow mononuclear stem cells(BMMSC). All treatments were performed by a single retinal specialist using topical proparacaine drops under sterile conditions (eyelid speculum and povidone-iodine). Autologous BMMSC were injected into the vitreous cavity using a 27 gauge needle inserted through the inferotemporal pars plana 3.0 - 3.5 mm posterior to the limbus. After the injection, central retinal artery perfusion was confirmed with indirect ophthalmoscopy. Patients were instructed to instill one drop of 0.3% ciprofloxacin into the injected eye four times daily for 1 week after the procedure.
16178203|NCT01560702|Drug|Epinephrine|10-30 cc of 1/10000 diluted epinephrine will be injected at edges of an actively bleeding ulcer.
16178204|NCT01560702|Biological|Blood|5-20 cc autologous blood immediately withdrawn from the patient will be injected at edges of the actively bleeding ulcer.
16178208|NCT01560676|Behavioral|HEALTH[e]TEEN + CST|12 lessons over 6-8 weeks
16178209|NCT01560663|Drug|Docetaxel- Carboplatin|Docetaxel 75mg/m2 day 1 and Carboplatin(AUC6)day 1, each 21 days for 6 cycles.
16178210|NCT01560650|Device|CRRT|Difference dose of CRRT
16178211|NCT01560637|Drug|UT-15C (treprostinil diethanolamine)|UT-15C sustained release oral tablet for three times daily administration
16178212|NCT01560624|Drug|Treprostinil Diolamine|Active
16178213|NCT01560624|Drug|Placebo|Placebo
16178214|NCT01560611|Device|Near infrared spectroscopy|
16178215|NCT01560585|Drug|Isotretinoin|Isotretinoin 0.5 mg per kilogram body weight (rounded to nearest 10 mg) per day for 24 weeks
16178216|NCT01560572|Drug|tacrolimus OD, mycophenolic acid, prednisolone|tacrolimus maintenance 6-10 ng/ml, in the low dose tacrolimus group after 6 months fixed dose reduction of 50% tacrolimus through levels will be 3-5 ng/ml mycophenolic acid 2 dd 720mg, after 2 weeks reduced to 2 dd 540 mg in all groups methylprednisolone 500, 250, 125 mg on day 0, 1, and 2 in all groups prednisolone 1 dd 10 mg, and from week 6 prednisolone 7.5 mg in the standard immunosuppression and low dose tacrolimus group No prednisolone will be given the steroid free group
16178217|NCT01560559|Procedure|Peroral endoscopic myotomy|"An endoscopy is performed under anesthesia with orotracheal intubation. After submucosal saline injection, an entry point in the submucosal space is created at 10 cm above the cardia. The endoscope will create a 12cm long tunnel in the caudal direction by submucosal dissection, stopping at 2cm below cardia. Then the muscular circular internal layer is sectioned on a 9cm length, starting 3 cm below the submucosal entry point. At the end the submucosal entry point is closed with metallic clips. A scanner is performed after the procedure so as to check the esophageal wall integrity. Alimentation is progressively introduced at day 1.
~This is a study of a procedure - peroral endoscopic myotomy (POEM). No new, unapproved device is used. All endoscopic tools are already approved for endoscopic submucosal dissection and associated complications (hemorrhage or perforation): dissection knifes, hot biopsy forceps, endoscopic metallic clips."
16178218|NCT01560546|Drug|Testosterone|50 mg/dose/day for 24 weeks
16178219|NCT01560546|Drug|Placebo|placebo on the skin for 24 weeks
16178220|NCT01560533|Behavioral|Interviews|Interviews will be done with patients
16178221|NCT01560520|Behavioral|Physical activity|Observation only
16178222|NCT01560507|Drug|varenicline (Chantix)|For the first 3 days after being switched from NRT (occurring at one week before the rescheduled quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.
16178223|NCT01560507|Drug|bupropion (Zyban)|After being switched from NRT (occurring at one week before the rescheduled quit date), smokers in this group will receive 150mg of bupropion once daily and 21mg nicotine patch for first 3 days; 150mg of bupropion twice daily and 21mg nicotine patch for 7 weeks; 150mg of bupropion twice daily and 14mg nicotine patch for 2 weeks and 150mg of bupropion twice daily and 7mg nicotine patch for 2 weeks.
16178224|NCT01560507|Drug|nicotine patches|21mg nicotine patch for first 11 weeks; 14mg nicotine patch for next 2 weeks; 7mg nicotine patch for final 2 weeks.
16178225|NCT01560494|Other|STAC curriculum|The STAC curriculum consists of theoretical preparation, case-based learning, proficiency-based virtual reality training, laparoscopic box training, and operating room participation.
16178226|NCT01560481|Drug|Step A: metformin glycinate 620 mg single dose|metformin glycinate 620 mg single dose
16178227|NCT01560481|Drug|Step A: metformin glycinate 1240 mg single dose|metformin glycinate 1240 mg single dose
16178228|NCT01560481|Drug|Step A: metformin glycinate 2480 mg single dose|metformin glycinate 2480 mg single dose
16178229|NCT01560481|Drug|Step A: metformin hydrochloride 1000 mg single dose|metformin Chlorhydrate 1000 mg single dose
16178230|NCT01560481|Drug|Step A: metformin glycinate 1240 mg,food intake|metformin glycinate 1240 mg, intake of food
16178231|NCT01560481|Drug|Step B: metformin glycinate 620 mg BID|metformin glycinate 620 mg BID, 8 days
16178232|NCT01560481|Drug|Step B: metformin hydrochloride 500 mg BID|metformin Chlorhydrate 500 mg BID, 8 days
16178233|NCT01560468|Drug|ITX 5061|300 mg given orally beginning at the time of liver transplantation and for 1 week post-transplant followed by 150 mg orally for an additional 21 days.
16178234|NCT01560455|Device|single stent|single stent
16178235|NCT01560455|Device|two stent|culotte
16178236|NCT01560442|Drug|Buprenorphine and Methadone Hydrochloride|To study the relation between pupillary diameter measured under scotopic conditions, and the pain thresholds measured at the time of peak and residual effect of methadone / buprenorphine in opiate-dependent patients following a substitution program.
16178237|NCT01560429|Procedure|Patient controlled epidural analgesia|Continuous epidural infusion rates were set to maintain pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 while in the post anesthesia care unit (PACU) following thoracotomy. Once stabilized patients were switched to Patient controlled epidural analgesia (PCEA) which meant they continued to receive 2/3rds of the dose as continuous background epidural infusions but they had the option to receive the remaining 1/3rd dosage via PCEA.
16178238|NCT01560429|Procedure|Continuous epidural analgesia|The continuous epidural analgesia (CEA) infusion rates were titrated to achieve pain scores of ≤ 3 on a numeric rating scale (NRS) of 0 to 10 while in post-anesthesia care unit (PACU) (as described for the PCEA group above). Those allocated to the CEA group remained on the same continuous epidural analgesia infusion which maintained the pain scores at ≤ 3.
16178239|NCT01560416|Drug|Fulvestrant|
16178240|NCT01560416|Drug|Ganetespib|
16178241|NCT01560403|Drug|Teduglutide|0.05 mg/kg/day subcutaneously taken once per day for 12 months
16178242|NCT01560390|Drug|Rémifentamil + KETAMINE|All consecutive mechanically ventilated patients admitted in the ICU will be randomized to receive an infusion of 0.15 mg/kg/h of kétamine or placebo. Nurses and physicians will be blinded of the allocation arm. The infusion of ketamine will be stopped as soon as remifentanil will be discontinued by the physician.
16178243|NCT01560390|Drug|ketamine|to evaluate the impact of ketamine associated to an opioid for sedation of mechanically ventilated critically ill patients versus placebo. Sedation will be drive by nurses according to an algorithm. The investigators will evaluate the quantity of opioates used in each arm and the safety of ketamine.
16178387|NCT01559259|Drug|Ibuprofen/acetaminophen|Two caplets of ibuprofen 150 mg plus acetaminophen 250 mg
16178244|NCT01560377|Device|PINPOINT Endoscopic Fluorescence Imaging System|The PINPOINT system will be used to provide real-time endoscopic visible and endoscopic NIR fluorescence imaging. PINPOINT enables surgeons to perform routine visible light endoscopic procedures as well as further visually assess vessels, blood flow and related tissue perfusion with near infra-red imaging during minimally invasive surgery
16178245|NCT01560364|Other|renal replacement therapy|Prospective observational clinical multicentric study in ICU with acute renal failure requiring renal replacement therapy.
16178246|NCT01560351|Device|rTMS|Two sessions of repeated Transcranial Magnetic Stimulation (real rTMS and sham rTMS) are planned for each participant, at interval of 4 weeks, in a random order.
16178247|NCT01560325|Drug|CKD-516 inj.|CKD-516: 3.3~13mg/m2/day
16178248|NCT01560312|Device|Renal denervation (Symplicity® Catheter System™)|4-6 ablation in both renal arteries using the Symplicity® Catheter System™ (Ardian/Medtronic)
16178249|NCT01560299|Drug|Methimazole|Methimazole was stopped 24-48 before radio-iodine therapy
16178250|NCT01560299|Drug|Methimazole|methimazole discontinued 49-72 hours before radioiodine treatment
16178251|NCT01560299|Drug|Methimazole|methimazole discontinued 73-168 hours before radio-iodine treatment
16178252|NCT01560286|Biological|BMN 165 (rAvPAL-PEG)|Subcutaneous injection of rAvPAL-PEG administered from 1 time up to 5 times per week between 2.5mg up to a maximum of 375mg for 24 weeks.
16178253|NCT01560273|Device|Aspen Spinous Process Fixation Device|The Aspen device will be placed as posterior fixation to Posterolateral Fusion (PLF)
16178254|NCT01560260|Other|Laboratory Biomarker Analysis|Correlative studies
16178255|NCT01560260|Drug|Linsitinib|Given PO
16178256|NCT01560260|Other|Pharmacological Study|Correlative studies
16178257|NCT01560247|Procedure|Mechanical thrombectomy|Mechanical thrombectomy using a MindFrame device
16178258|NCT01560234|Drug|AZD8848|Single dose, oral inhalation (nebuliser solution)
16178259|NCT01560234|Drug|Placebo|Single dose, oral inhalation (nebuliser solution)
16178260|NCT01560221|Behavioral|Therapeutic Workplace|Participants can access stipend supported academic and job skills training for adults and/or receive wages or wage subsides for actual employment. Access to training and employment is contingent upon meeting therapeutic targets. Potential targets include, but are not limited to, drug abstinence and medication adherence.
16178261|NCT01560221|Drug|Methadone|Methadone in liquid form, with the dosage determined by physician on an individual basis. Anticipated dose range 30mg to 100mg daily. Methadone is administered daily at a methadone clinic for as long as enrollment in the methadone clinic is maintained.
16178262|NCT01560221|Drug|Buprenorphine|Subutex (buprenorphine hydrochloride) and Suboxone tablets (buprenorphine hydrochloride and naloxone hydrochloride) are approved for the treatment of opiate dependence. Subutex and Suboxone treat opiate addiction by preventing symptoms of withdrawal from heroin and other opiates.
16178263|NCT01560195|Drug|Pegylated rhG-CSF: 100µg/kg|Patients were administered pegylated rhG-CSF 100 ug/kg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: docetaxel 75 mg/m2; carboplatin area under curve[AUC] 5 or cisplatin 75 mg/m2.
16178264|NCT01560195|Drug|Pegylated rhG-CSF: 6mg|Patients were administered pegylated rhG-CSF 6mg once at the 3rd day of every chemotherapy cycle. Chemotherapy regimen: docetaxel 75 mg/m2; carboplatin area under curve[AUC] 5 or cisplatin 75 mg/m2.
16178265|NCT01560195|Drug|placebo and rhG-CSF 5ug/kg/d|Patients receiving chemotherapy and placebo in cycle 1 and rhG-CSF 5ug/kg/d in cycle 2 to 4. Chemotherapy regimen: docetaxel 75 mg/m2; carboplatin area under curve[AUC] 5 or cisplatin 75 mg/m2.
16178266|NCT01560182|Genetic|OTL-200 Gene Therapy|Autologous hematopoietic stem/progenitor cells collected from the bone marrow and transduced ex vivo with a Lentiviral vector encoding the human ARSA cDNA
16178267|NCT01560143|Drug|Tigecycline|100 mg IV as a single infusion over 30 minutes
16178268|NCT01560130|Behavioral|Shape Up Rhode Island + Online weight loss program|Participants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention and an Internet-based behavioral weight loss program.
16178269|NCT01560130|Behavioral|Shape Up Rhode Island + Online weight loss program + Groups|Participants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention, an Internet-based behavioral weight loss program, and the option to attend group sessions.
16178270|NCT01560130|Behavioral|Shape Up Rhode Island + Online weight loss + Incentives|Participants assigned to this arm will receive the standard Shape Up Rhode Island statewide intervention, an Internet-based behavioral weight loss program, and monetary incentives for submitting self-monitoring information and for achieving clinically significant weight loss.
16178271|NCT01560117|Drug|Rituximab|Rituximab 375 mg/m2 i.v. every 2 months for 24 months
16178272|NCT01560104|Drug|Veliparib|
16178273|NCT01560104|Drug|Carboplatin|
16178274|NCT01560104|Drug|paclitaxel|
16178275|NCT01560104|Drug|placebo|
16178276|NCT01560091|Drug|silodosin|8mg PO Qday
16178277|NCT01560091|Procedure|Extra-corporeal shock wave lithotripsy|ESWL
16178278|NCT01560091|Drug|Tamsulosin|Tamsulosin 0.4mg PO Qday
16178279|NCT01560065|Dietary Supplement|myo-inositol + folic acid|4000mg myo-inositol + 400 µg folic acid
16178280|NCT01560065|Dietary Supplement|myo-inositol + folic acid|4000mg myo-inositol + 400 µg folic acid
16178281|NCT01560052|Drug|methylprednisolone|"Original Cohort:
~Oral methylprednisolone or placebo 0.8mg/kg/day with a maximum of 48mg/day x 2months, taper by 8mg/day every month, patients will also receive optimal blood pressure control and full dose of ACE inhibitors or ARBs as recommended by guidelines
~Low Dose Cohort:
~Oral methylprednisolone or placebo 0.4mg/kg/day with a maximum 32mg/day and minimum of 24mg/day then reducing over 6-9months. All the patients will also receive optimal blood pressure control and full dose of ACE inhibitors or ARBs as recommended by guidelines throughout the trial.
~Prophylactic trimethoprim/sulfamethoxazole (a single strength tablet daily or half a double strength tablet daily) will be used during the first 3 months after randomisation in the low dose cohort, for the prevention of severe PJP infection, unless there is a documented sulfa allergy."
16178349|NCT01559428|Dietary Supplement|Plant sterol-enriched margarine|Daily consumption of 20 gram of a plant sterol-enriched margarine (providing daily 3.0 gram of plant sterols), for a period of 4 weeks. At the end of the 4 weeks, subjects will undergo a postprandial test for 8 hours, in which 20 gram of the plant sterol-enriched margarine is consumed together with a high-fat milkshake
16178282|NCT01560052|Drug|Placebo|"Intervention: Drug: Placebo
~Original Cohort:
~Matching placebo tablets, all the patients will receive optimal blood pressure control and full dose of ACE inhibitors or ARBs as recommended by guidelines throughout the trial.
~Low Dose cohort:
~Matching placebo will be given reducing over 6-9months. All the patients will also receive optimal blood pressure control and full dose of ACE inhibitors or ARBs as recommended by guidelines throughout the trial.
~Prophylactic trimethoprim/sulfamethoxazole (a single strength tablet daily or half a double strength tablet daily) will be used during the first 3 months after randomisation in the low dose cohort, for the prevention of severe PJP infection, unless there is a documented sulfa allergy"
16178283|NCT01560039|Device|TMS|Transcranial magentic stimulation of the motor cortex. Device Details : Model is Magstim TMS Rapid. Manufacturer : MAGSTIM CO LTD. Spring Gardens, Whitland, Carmarthenshire, Wales, U.K., SA34 0HR
16178284|NCT01560039|Other|Neurofeedback|EEG neurofeedback based on the primary motor cortex
16178285|NCT01560039|Other|Sham neurofeedback|Sham EEG neurofeedback
16178286|NCT01560026|Procedure|surgery|endometrial cancer with or without oophorectomy
16178287|NCT01560013|Drug|Naltrexone|Naltrexone, oral 50 mg per day.
16178288|NCT01560000|Dietary Supplement|Dietary fiber|Wheat, barley, oat and bran fibers added to a breakfast product
16178289|NCT01559987|Other|Manual Toothbrush only|ADA (American Dental Association) Reference Manual Toothbrush (MTB)
16178290|NCT01559987|Other|MTB + Waterpik Ultra Water Flosser 'High'|MTB + Waterpik Ultra Water Flosser 'High'
16178291|NCT01559987|Other|MTB + Floss (MTB+Floss)|MTB + Floss (MTB+Floss)
16178292|NCT01559974|Drug|Placebo|Placebo to 45'000 units of Cholecalciferol per month for 3 months
16178293|NCT01559974|Drug|Cholecalciferol|45'000 units of cholecalciferol per month for 3 months
16178294|NCT01559961|Drug|TTI-1612|Single intravesical 30-minute treatments with escalating doses of TTI-1612.
16178295|NCT01559948|Behavioral|Lumbopelvic stabilization exercise|The objective of this exercise program is to recruit and train the primary stabilizing muscles of the spine in order for them to more appropriately support the spine. Participants will complete 4 different exercises daily: one in supine, one in standing, one in quadruped, and one in a side-bridge position. The dosage for each exercise is 20 reps with an 8 second hold. In supine, the first exercise is the abdominal drawing-in maneuver. In standing, the first exercise is the abdominal drawing-in maneuver. In quadruped, the first exercise is alternating arm lifts. The final exercise is the side-bridge hold. Participants will then be asked to attend supervised physical therapy sessions twice a week for 2 weeks and once a week for another 2 weeks. They will be instructed to perform the exercises at home daily for a total of 12 weeks as well as complete a compliance log. Progression of the stabilization program will be determined by the physical therapist based on pre-established criteria.
16178296|NCT01559948|Device|Sacroiliac joint belt|The belt should be worn low around the pelvis just above the greater trochanter and instructed to wear the belt during all waking hours of the first four weeks of the study. The treating physical therapist will monitor the placement of belts during each exercise session. Belt usage logs will be given to each participant to assess compliance with wearing the belt.
16178297|NCT01559935|Drug|carfilzomib|45 mg/m2 IV on days 1, 2, 8, 9, 15 and 16 of each 28 day cycles.
16178298|NCT01559935|Drug|Dexamethasone|20 mg orally on days 1, 2, 8, 9, 15 and 16 of a 28 day cycle, while receiving carfilzomib.
16178299|NCT01559935|Drug|Clarithromycin|500 mg twice a day for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
16178300|NCT01559935|Drug|Lenalidomide|25 mg orally days 1-21 for each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
16178301|NCT01559935|Drug|Dexamethasone|40 mg orally on days 1, 8, 15 and 22 of each 28 day cycle of BiRD treatment. BiRD begins after carfilzomib treatment has been completed.
16178302|NCT01559935|Drug|Lenalidomide|10 mg orally on days 1-21 or each 28 day cycle of maintenance. Maintenance begins after BiRD treatment has been completed.
16178303|NCT01559922|Drug|Normal Saline|Administration of up to 2 study treatments administered 6 weeks apart
16178304|NCT01559922|Device|Artefill|Administration of up to 2 study treatments administered 6 weeks apart
16178305|NCT01559909|Device|Vacuum assisted socket technology (Harmony System, Otto Bock Healthcare)|The brim height of the socket will be systematically reduced
16178306|NCT01559896|Dietary Supplement|protein hydrolysate capsules and placebo capsules|Once in the study, 20 subjects will be randomly assigned to a group taking capsules containing 5 gr egg protein hydrolysate per day, and 20 to a group taking placebo capsules. The subjects consume the capsules during three consecutive days (period 1). Following a wash-out period of minimally four weeks, the treatments are crossed-over.
16178307|NCT01559883|Other|no intervention is being made|This is a Non-Interventional Study (NIS)
16178308|NCT01559857|Drug|Pioglitazone|30mg once daily for 12 weeks
16178309|NCT01559857|Drug|Sugar Pill|Placebo
16178310|NCT01559844|Drug|Sofosbuvir|Sofosbuvir 400 mg (2 x 200 mg tablets) administered orally once daily
16178311|NCT01559844|Drug|Ribavirin|Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
16178312|NCT01559831|Biological|IXIARO|Vero-cell derived Japanese encephalitis (JE) vaccine IXIARO, 0.5 ml intramuscular
16178313|NCT01559818|Biological|IMM-101|IMM-101 10mg/mL, a suspension of heat-killed whole cell M. obuense in borate-buffered saline.
16178314|NCT01559805|Behavioral|Positive Choices|A two-session, individually-focused intervention focusing on engagement in care, disclosure decision-making, and sexual risk reduction, with booster sessions after 1, 3 and 6 months.
16178315|NCT01559805|Behavioral|Personalized Cognitive Counseling|A one-session, individually-focused risk reduction intervention for MSM that has been selected by the CDC as a DEBI.
16178350|NCT01559428|Dietary Supplement|Plant stanol-enriched margarine|Daily consumption of 20 gram of a plant stanol-enriched margarine (providing daily 3.0 gram of plant stanols), for a period of 4 weeks. At the end of the 4 weeks, subjects will undergo a postprandial test for 8 hours, in which 20 gram of the plant stanol-enriched margarine is consumed together with a high-fat milkshake
16178351|NCT01559428|Dietary Supplement|Control margarine|Daily consumption of 20 gram of a control margarine, for a period of 4 weeks. At the end of the 4 weeks, subjects will undergo a postprandial test for 8 hours, in which 20 gram of the control margarine is consumed together with a high-fat milkshake
16178316|NCT01559753|Drug|Augmentin, Ceftriaxone, Cefotaxime, netilmycin, tobramycin|"All patients included in the study will be treated by a combination of antibiotics during the first 5 days, then by monotherapy for either 3 or 10 days according to their allocated group.
~Beta-Lactams:
~Amoxicillin + clavulanic Acid : 2 g TDS for 3 days, then 1 g TDS
~Ceftriaxone : 2 g OD during 3 days, then 1 g OD
~Cefotaxime : 2 g TDS during 3 days, then 1 g TDS
~Aminoglycosides
~Tobramycin : loading dose of 6 mg/kg OD, then 5 mg/kg OD (adaptation in case of renal failure)
~Netilmicin : loading dose of 10 mg/kg OD, then 8 mg/kg OD (adaptation in case of renal failure)
~Dibekacin : loading dose of 6 mg/kg OD, then 5 mg/kg OD (adaptation in case of renal failure)"
16178317|NCT01559753|Drug|compare 8 to15 days of antibiotic treatment|"All patients included in the study will be treated by a combination of antibiotics during the first 5 days, then by monotherapy for either 3 or 10 days according to their allocated group.
~•
~Beta-Lactams:
~Amoxicillin + clavulanic Acid : 2 g TDS for 3 days, then 1 g TDS
~Ceftriaxone : 2 g OD during 3 days, then 1 g OD
~Cefotaxime : 2 g TDS during 3 days, then 1 g TDS
~Aminoglycosides
~Tobramycin : loading dose of 6 mg/kg OD, then 5 mg/kg OD (adaptation in case of renal failure)
~Netilmicin : loading dose of 10 mg/kg OD, then 8 mg/kg OD (adaptation in case of renal failure)
~Dibekacin : loading dose of 6 mg/kg OD, then 5 mg/kg OD (adaptation in case of renal failure)"
16178318|NCT01559740|Drug|Bupivacaine|This is being used as the local anesthetic for the TAP blocks at either 0.25% or 0.125%. The block will be done once during the procedure.
16178319|NCT01559727|Drug|prednisone|The patients with symptomatic heart failure are treated with prednisone at dose of 15 mg/day.
16178320|NCT01559727|Drug|prednisone|The patients with symptomatic heart failure are treated with prednisone at dose of 30 mg/day
16178321|NCT01559727|Drug|prednisone|The patients with symptomatic heart failure are treated with prednisone at dose of 60 mg/day
16178322|NCT01559701|Drug|PF-00345439|5-80 mg twice-a-day for 12 months
16178323|NCT01559688|Behavioral|Accelerated Resolution Therapy (ART)|ART is a cognitive based therapy which integrates an eye movement technique while focusing on a problem (traumatic experience) during the therapy session.
16178324|NCT01559688|Behavioral|Waitlist|Fitness assessment or career counseling
16178325|NCT01559675|Drug|Hydrocortisone High Dose|Patients receive Hydrocortisone 100 mg at surgical incision followed by 100mg IV every 8 hours for the first 24 hours, followed by 75 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 8 hours for 24 hours, followed by 50 mg IV every 12 hours, followed by Prednisone 20 mg orally when oral diet is resumed
16178326|NCT01559675|Drug|Hydrocortisone Low Dose|1/3 IV equivalent dose (IVED) (hydrocortisone equivalent of the patient's preoperative steroid dose) at surgical incision, followed by 1/3 IVED for 24 hours, Patients subsequently treated with 1/4 IVED every 8 hours starting Postoperative day (POD 1), followed by 1/6 IVED every 8 hours on POD 2 and every 12 hours starting POD 3. On POD 4 or when the patient was tolerating a regular diet, oral prednisone equal to the most recent IV hydrocortisone dose resumed
16178327|NCT01559662|Dietary Supplement|Sugared Chewing Gum (Juicy Fruit)|One stick of gum, 3 times daily from Postoperative day 1 to 7
16178328|NCT01559649|Behavioral|Establishing Validity and Reliability|Consecutive individuals admitted with suspected stroke will be recruited to participate. Individuals will undergo screening of swallowing and a videofluoroscopic swallow study within two hours. Eight screening items will be tested for validity and inter-rater reliability: 6 nonswallowing features and 2 swallowing features. Reliability in nursing observations of each screening item will be completed in all participants. Speech pathologists trained in the screening items will serve as the reference standard from which to compare reliability with registered nurses who routinely work on the hospital ward with stroke patients
16178329|NCT01559636|Biological|bivalent oral polio vaccine|vaccine given during immunization campaigns
16178330|NCT01559623|Procedure|retrospective data analysis|retrospective data analysis
16178331|NCT01559610|Other|Intervention Group|The patients were instructed by a nurse
16178332|NCT01559597|Biological|Tetanus toxoid vaccine|Two doses of tetanus toxoid vaccine separated at least 4 weeks. One arm receives the vaccine kept in cold chain and the other arm receives the vaccine kept in CTC
16178333|NCT01559584|Radiation|ultraviolet A (UVA)|"0.5% solution of 8-methoxypsoralen (MOP) will be applied 20 minutes before UVA exposure (315-400nm).
~UVA sessions will be carried out twice weekly aiming to achieve a phototoxic reaction, in the form of erythema and vesiculation. Once a phototoxic reaction will be achieved, the patient will be asked to rest until the reaction subsides and then resume the phototherapy sessions."
16178334|NCT01559584|Drug|Triamcinolone Acetonide|One monthly injections of intralesional triamcinolone acetonide
16178335|NCT01559558|Procedure|vaginal packing|vaginal packing after urodynamic studies, and repeat urethral pressure profile
16178336|NCT01559545|Drug|Metronidazole|Immediate release metronidazole 500 mg orally three times a day for 14 days
16178337|NCT01559545|Drug|Metronidazole-DRF1|Modified release metronidazole (DRF1) 500 mg orally three times a day for 14 days.
16178338|NCT01559545|Drug|Metronidazole-DRF2|Modified release metronidazole (DRF2) 500 mg orally three times a day for 14 days.
16178339|NCT01559519|Drug|Albumin|albumin 20% 1 g/Kg body weight for the first two days after TIPS followed by 0,5 g/Kg body weight at day 4 and then 0,5 g/Kg body weight once a week for three weeks.
16178340|NCT01559506|Device|Air Barrier System device|Device is deployed adjacent to the surgery site and activated.
16178341|NCT01559480|Drug|Desogestrel|Desogestrel 75 mcg Takes 1 capsule before bedtime for 6 months
16178342|NCT01559480|Drug|Placebo|Placebo capsule takes 1 capsule before bedtime for 6 months
16178343|NCT01559467|Other|Cardiovascular Magnetic Resonance Imaging|Routine clinical care plus cardiovascular magnetic resonance imaging early in the diagnostic process
16178344|NCT01559467|Other|Computed Tomography Angiography|Routine clinical care plus computed tomography angiography early in the diagnostic process
16178345|NCT01559454|Drug|Methadone|10-60 mg/day divided by 2-4 times a day for 6 months
16178346|NCT01559454|Drug|Buprenorphine/naloxone|4-16 mg/day divided by 2-4 times a day for 6 months
16178347|NCT01559441|Dietary Supplement|Beetroot Juice with oral fat load|140mL (9.6 mmol nitrate) beetroot juice (Beet It, James White drinks Ltd)
16178348|NCT01559441|Dietary Supplement|Carbohydrate control drink with oral fat load|140 mL (low-nitrate) carbohydrate control drink
16178352|NCT01559415|Other|Meal replacement diet using Modifast|modifast intensive diet replacing all regular meals (500 kcal/d) for 5 weeks
16178353|NCT01559415|Other|Normal diet combined with Modifast diet|Combination of modifast and regular diet (1250 kcal/d) for 3 months
16178354|NCT01559402|Procedure|CPAP and 100% oxygen|During pre oxygenation and induction of anesthesia 100 % oxygen is used with a continuous positive airway pressure of 10 cmH2O, during maintenance of anesthesia a positive endexpiratory pressure of 10 cm H20 is used with controlled volume ventilation aiming at an end tidal carbon dioxide (CO2) level of 5 %. During emergence from anesthesia 100 % oxygen is used.
16178355|NCT01559402|Procedure|CPAP and 31% oxygen|During pre oxygenation and induction of anesthesia 100 % oxygen is used with a continuous positive airway pressure of 10 cm H2O, during maintenance of anesthesia a positive endexpiratory pressure of 10 cm H20 is used with controlled volume ventilation aiming at an end tidal CO2 level of 5 %. During emergence from anesthesia 31 % inspiratory oxygen or the inspiratory oxygen level needed to achieve a SpO2 of at least 96 % (if 31 % oxygen is not enough), is used.
16178356|NCT01559402|Procedure|No CPAP and 100% oxygen|This intervention follows a standard protocol without the use CPAP during induction of anesthesia.
16178357|NCT01559389|Drug|Solifenacin|Women presenting with UUI symptoms receive 5 to 10 milligrams (mg) of daily solifenacin for up to 16 weeks
16178358|NCT01559363|Drug|KD019 (tesevatinib)|KD019 (tesevatinib) administered orally once daily.
16178359|NCT01559350|Procedure|A right gastroepiploic artery in situ grafting|A right gastroepiploic artery in situ grafting in the right coronary artery system during OPCAB
16178360|NCT01559350|Procedure|A saphenous vein grafting|A saphenous vein grafting in the right coronary artery system during OPCAB
16178361|NCT01559337|Procedure|Nerve transfer|the dorsal branch was used as a pedicle nerve for reconstructing PDN defects
16178362|NCT01559324|Device|ECT|Bifrontal ECT, low dosage
16178363|NCT01559324|Device|ECT|Right unilateral electrode position, high dosage
16178364|NCT01559311|Device|CRT-P OFF|CRT Pacemaker
16178365|NCT01559311|Device|CRT-P ON|CRT Pacemaker
16178366|NCT01559311|Device|DDDR|Dual-chamber, rate-modulated pacemaker
16178367|NCT01559298|Drug|Aspirin (80 mg/d) + clopidogrel (75 mg/d)|Aspirin (80 mg/d) + clopidogrel (75 mg/d) Aspirin therapy will start at least 24 hrs before the TAVI procedure and continued for at least 6 months. Clopidogrel therapy will start within 24 hrs before the TAVI procedure in cases where a transfemoral approach is used and within 24 hrs after the TAVI procedure in cases where a transapical approach is used. The initial dose of clopidogrel will be of 300 mg followed by 75 mg/die. The duration of clopidogrel treatment will be of 3 months. Patients will be followed either by phone contact or clinical visits at 1- and 12-month follow-up.
16178368|NCT01559298|Drug|Aspirin|Aspirin (80 mg/d) Aspirin therapy will start at least 24 hrs before the TAVI procedure and continued for at least 6 months.
16178369|NCT01559285|Drug|0.75% ropivacaine concentration|0.75% ropivacaine 8ml was injected epidurally after induction of general anesthesia
16178370|NCT01559285|Drug|0.375% ropivacaine concentration|0.375% ropivacaine 8ml was injected epidurally after induction of general anesthesia
16178371|NCT01559285|Drug|0.2% ropivacaine concentration|0.2% ropivacaine 8ml was injected epidurally after induction of general anesthesia
16178372|NCT01559272|Drug|Paliperidone IR (Period 1)|Type= exact number, unit= mg, number=1, form= injection, route= intramuscular use. Single injection with 1 mg paliperidone IR in the gluteal or deltoid muscle.
16178373|NCT01559272|Drug|Paliperidone palmitate F015 (Panel A: treatment group 1)|Type= exact number, unit= mg, number=300, form= injection, route= intramuscular use. Single injection with 300 mg eq. 3-month formulation paliperidone palmitate F015 manufactured by milling technique A, in the gluteal muscle.
16178374|NCT01559272|Drug|Paliperidone palmitate F015 (Panel A: treatment group 2)|Type= exact number, unit= mg, number=300, form= injection, route= intramuscular use. Single injection with 300 mg eq. 3-month formulation paliperidone palmitate F015 manufactured by milling technique B, in the gluteal muscle.
16178375|NCT01559272|Drug|Paliperidone palmitate F015 (Panel B: treatment group 1)|Type= exact number, unit= mg, number= 75, form= injection, route= intramuscular use. Single injection with 75 mg eq. 3-month formulation paliperidone palmitate F015 in the gluteal muscle.
16178376|NCT01559272|Drug|Paliperidone palmitate F015 (Panel B: treatment group 2)|Type= exact number, unit= mg, number=150, form= injection, route= intramuscular use. Single injection with 150 mg eq. 3-month formulation paliperidone palmitate F015 in the gluteal muscle.
16178377|NCT01559272|Drug|Paliperidone palmitate F015 (Panel B: treatment group 3)|Type= exact number, unit= mg, number=450, form= injection, route= intramuscular use. Single injection with 450 mg eq. 3-month formulation paliperidone palmitate F015 in the gluteal muscle.
16178378|NCT01559272|Drug|Paliperidone palmitate F015 (Panel B: treatment group 4)|Type= exact number, unit= mg, number=300, form= injection, route= intramuscular use. Single injection with 300 mg eq. 3-month formulation paliperidone palmitate F015 in the deltoid muscle.
16178379|NCT01559272|Drug|Paliperidone palmitate F015 (Panel B: treatment group 5)|Type= exact number, unit= mg, number=450, form= injection, route= intramuscular use. Single injection with 450 mg eq. 3-month formulation paliperidone palmitate F015 in the deltoid muscle.
16178380|NCT01559272|Drug|Paliperidone palmitate F016|Type= exact number, unit= mg, number=150, form= injection, route= intramuscular use. Single injection with 150 mg eq. 3-month formulation paliperidone palmitate F016 in the gluteal muscle.
16178381|NCT01559272|Drug|Paliperidone palmitate F015 (Panel D: treatment group 1)|Type= exact number, unit= mg, number=525, form= injection, route= intramuscular use. Single injection with 525 mg eq. 3-month formulation paliperidone palmitate F015 in the gluteal muscle.
16178382|NCT01559272|Drug|Paliperidone palmitate F015 (Panel D: treatment group 2)|Type= exact number, unit= mg, number=525, form= injection, route= intramuscular use. Single injection with 525 mg eq. 3-month formulation paliperidone palmitate F015 in the deltoid muscle.
16178383|NCT01559272|Drug|Paliperidone palmitate F015 (Panel D: treatment group 3)|Type= exact number, unit= mg, number=350, form= injection, route= intramuscular use. Single injection with 350 mg eq. 3-month formulation paliperidone palmitate F015 in the gluteal muscle.
16178384|NCT01559272|Drug|Paliperidone palmitate F015 (Panel D: treatment group 4)|Type= exact number, unit= mg, number=175, form= injection, route= intramuscular use. Single injection with 175 mg eq. 3-month formulation paliperidone palmitate F015 in the deltoid muscle.
16178385|NCT01559259|Drug|Ibuprofen/acetaminophen|Two caplets of ibuprofen 100 mg plus acetaminophen 250 mg
16178386|NCT01559259|Drug|Ibuprofen/acetaminophen|Two caplets of ibuprofen 125 mg plus acetaminophen 250 mg
16178390|NCT01559233|Device|FPlus RF device for wrinkles and rhytide reduction|Six RF weekly treatments for face wrinkles and rhytides reduction using the FPlus device.
16178391|NCT01559220|Device|Deep Brain Stimulation|Implanted device
16178392|NCT01559194|Behavioral|Low Fat Diet plus exercise|Low fat diet plus exercise - Subjects were educated about a low fat diet plus exercise and then followed for weight loss. They were also asked to monitor their physical activity by wearing a pedometer and recording the total steps walked every day.
16178393|NCT01559194|Behavioral|Low Carbohydrate diet + Exercise|Low carbohydrate diet plus exercise: Subjects were educated about a low carbohydrate diet and then followed for weight loss. They were also asked to monitor their physical activity by wearing a pedometer and recording the total steps walked every day.
16178394|NCT01559168|Device|UpholdTM LITE placement|Uphold TM LITE mesh is used for the surgical correction of pelvic organ prolapse.
16178395|NCT01559142|Drug|Infliximab with azathioprine (IIFX + AZA)|Infliximab with azathioprine during whole one year study
16178396|NCT01559142|Drug|Infliximab (IFX alone)|Infliximab continuously; azathioprine stopped in 26 week
16178397|NCT01559129|Drug|Pomalidomide (CC-4047)|1 mg orally every day for 52 weeks
16178398|NCT01559129|Drug|Placebo|Matching placebo capsules taken orally once a day
16178399|NCT01559116|Drug|tiotropium + olodaterol|low dose + one dose only
16178400|NCT01559116|Drug|tiotropium|low dose
16178401|NCT01559116|Drug|olodaterol|one dose only
16178402|NCT01559116|Drug|tiotropium|high dose
16178403|NCT01559116|Drug|tiotropium + olodaterol|low dose + one dose only
16178404|NCT01559116|Drug|Placebo|placebo matching tiotropium+olodaterol FDC
16178405|NCT01559116|Device|Respimat|Respimat inhaler
16178406|NCT01559103|Biological|MEDI5117|Intravenous infusion administered over 60 minutes, will be one of the following doses: 30, 100, 300, or 600 mg
16178407|NCT01559103|Biological|MEDI5117 Placebo|Intravenous infusion administered over 60 minutes
16178408|NCT01559090|Drug|MEDI-546|Stage I: 100 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks
16178409|NCT01559090|Drug|MEDI-546|Stage I: 300 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 300 mg IV, multiple doses once every 4 wks for 156 wks
16178410|NCT01559090|Drug|MEDI-546|Stage I: 1000 mg IV, single dose and multiple doses once every 4 wks for 48 wks Stage II: 1000 mg IV, multiple doses once every 4 wks for 156 wks, the dose at Stage II was changed to 300 mg IV.
16178411|NCT01559077|Drug|ALN-TTR02|Dose levels between 0.01 and 0.5 mg/kg by intravenous (IV) infusion
16178412|NCT01559077|Drug|Sterile Normal Saline (0.9% NaCl)|Calculated volume to match active comparator
16178413|NCT01559064|Device|Crosslinked hyaluronic acid gel (Juvéderm VOLUMA®)|All treatment details are at the discretion of the investigator and should be guided by the appropriate directions for use.
16178414|NCT01559051|Procedure|Lipoaspiration with Local anesthesia|Patients undergo a liposuction under local Anethesia. The AD-SVF are then isolated and infused IV and by inhalation delivery.
16178415|NCT01559025|Drug|Vildagliptin|Vildagliptin ( Galvus 50mg twice day) during one year
16178416|NCT01559012|Drug|Clonidine|transdermal clonidine patch 5 mg q. 5 days
16178417|NCT01558999|Drug|High concentration SI-614|1 drop in each eye 4 times a day
16178418|NCT01558999|Drug|Low concentration SI-614|1 drop in each eye 4 times a day
16178419|NCT01558999|Drug|Vehicle|1 drop in each eye 4 times a day
16178420|NCT01558986|Procedure|Cefazolin|Patients received intravenous cefazolin 1 gram within 30 minutes prior to skin incision;
16178421|NCT01558986|Procedure|Sterile water|Patients received sterile water only within 30 minutes prior to skin incision
16178422|NCT01558960|Drug|IVit Melphalan|IVit injections of Melphalan
16178423|NCT01558947|Drug|Peri-operative chemotherapy of ECX|Preoperative chemotherapy of ECX for 3 cycles(Epirubicin 50mg/m2 on day 1; capecitabine 1000mg/m2, 2 times / day, 1 to 14 days; cisplatin 60mg/m2 on day 1, need hydration, 21 day/cycle), operation after 2~4 weeks, and postoperative chemotherapy of ECX for 3 cycles 4~6 weeks after surgery.
16178424|NCT01558947|Drug|Peri-operative chemotherapy of XP|Preoperative chemotherapy of XP for 3 cycles(capecitabine 1000mg/m2, 2 times / day, 1 to 14 days; cisplatin 60mg/m2 on day 1, need hydration, 21 day/cycle), operation after 2~4 weeks, and postoperative chemotherapy of XP for 3 cycles 4~6 weeks after surgery.
16178425|NCT01558934|Drug|Lofexidine HCl|Lofexidine HCl 0.2 mg tablets titrated in ascending doses of 0.2 mg QID (e.g. Day 1 0.2 mg QID, Day 2 0.4 QID, etc)as described in the treatment arm.
16178426|NCT01558921|Other|M1 scheme|short course 5 x 5 Gy radiation scheme is followed by six cycles of combination chemotherapy (capecitabine and oxaliplatin (CAPOX)) and surgery. FOLFOX4 may be given as alternative for CAPOX
16178427|NCT01558921|Other|standard long course chemoradiotherapy|long course chemoradiotherapy followed by surgery. Optional adjuvant chemotherapy (CAPOX or FOLFOX) is allowed in the control group.
16178428|NCT01558908|Biological|Administration of ERC|Patients will be treated with either 25 million, 50 million, or 100 million ERC by intramuscular injection.
16178429|NCT01558895|Radiation|Infrared ray heat treatment|Patients in experimental group accepted Infrared ray heat treatment in hepatic area for 30 minutes as well as conventional therapy.
16178430|NCT01558895|Other|conventional treatment|Conventional treatment consists of antiviral drugs, lowering aminotransferase and jaundice medicine.
16178431|NCT01558882|Device|Essure|Essure devices are deployed according to manufacturer's instructions for tubal sterilization.
16178432|NCT01558869|Drug|Capecitabine|1200 mg/m2 BD orally for 1 week of a 2-week cycle (i.e. 1 week on, 1 week off)
16178433|NCT01558869|Drug|Oxaliplatin|70 mg/m2 IV on day 1 of a 2-week cycle
16178434|NCT01558869|Drug|Irinotecan|130 mg/m2 IV on day 1 of a 2-week cycle
16178435|NCT01558856|Procedure|Unilateral electrode placement and testing|An electrode is placed near a sacral nerve with an anal motor response under general anesthesia. During and adjustment phase, the electode is connected to a test box which allows for adjustment of stimulation parameters. After pinpointing stimulation parameters, the external test box is replaced by an implanted device.
16178500|NCT01558414|Procedure|FSIS cholecystectomy|Cholecystectomy performed by Flexible Single Incision Surgery with the flexible endoscope through a single incision at the umbilicus
16184224|NCT01514929|Drug|Placebo|Placebo oral pill given once
16178436|NCT01558856|Procedure|Bilateral electrode placement and testing|Two electrodes are placed, one near each sacral nerve under general anesthesia. During an adjustment phase, the electodes are connected to a test box which allows for adjustment of stimulation parameters. This can result in the use of one or the other, or both electrodes, thus increasing the chances of success and the possibility that the patient is eligible for an implant. After pinpointing stimulation parameters, the external test box is replaced by an implanted device.
16178437|NCT01558830|Drug|ranolazine|ranolazine 500mg twice daily, may increase to 1000 mg twice daily for therapy optimization in treating chronic stable angina
16178438|NCT01558830|Drug|placebo|one pill twice daily, to increase to two pills twice daily to mirror standard ranolazine treatment strategy
16178439|NCT01558817|Behavioral|Informed Assent|Patients receive informed assent approach toward in-hospital CPR outcomes. Patients are informed that their underlying chronic illness makes outcomes after CPR so poor that CPR is not performed while allowing them to disagree.
16178440|NCT01558817|Behavioral|Informational Brochure|An informational brochure about CPR will be given without a discussion with a physician.
16178441|NCT01558804|Other|Identifying group A strep carriers|At study entry, at 14 days, and if follow up is positive, again in 14-21 days: Standard culture for GAS and analysis of mRNA.
16178442|NCT01558791|Other|TBI handout|The intervention is an educational handout which covers key concepts found in the empirical literature and explicated in the VA/DoD mTBI practice guideline; (1) the meaning of a positive screen, (2) symptoms may be due to another condition, (3) most people with mTBI recover.
16178443|NCT01558778|Procedure|management of therapy complications|Undergo mechanical stimulation
16178444|NCT01558778|Procedure|musculoskeletal complications management/prevention|Undergo mechanical stimulation
16178445|NCT01558765|Other|Integrated rehabilitation|Integrated rehabilitation consisting of exercise training (3 times per week (1 hour) for 12 weeks) and psycho-educational care (5 consultations over 6 months by special trained nurses).
16178446|NCT01558752|Device|Total hip replacement with titanium shell and CORAIL stem|Patients that are randomized into Group 1 will receive a total hip replacement with the following components: CORAIL (impaction broach) titanium stem and a monoblock cup with ceramic on ceramic bearing (DELTA motion).
16178447|NCT01558752|Device|Total hip replacement with Modular Titanium Femoral Stem|Patients that are randomized into Group 2 will receive a total hip replacement with the following components: the Trilock-Pinnacle system (titanium stem and titanium cup with polyethylene insert).
16178448|NCT01558739|Drug|INC424|Ruxolitinib was provided in 5 mg tablets, packaged in bottles. 15 - 20 mg (dose based on Baseline platelet count) twice daily.
16178449|NCT01558726|Behavioral|Case Management (Strength-Based)|To improve the cases sharing between CAPSad and other health institutions and individuals and increase the strengths of the patient to cope with problems related to the crack use.
16178450|NCT01558726|Behavioral|Usual Treatment|The usual treatment used for regular patients of CAPSad
16178451|NCT01558713|Drug|Bupivacaine- Fentanyl - Normal Saline|Bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus
16178452|NCT01558713|Drug|Ropivacaine-Fentanyl-Normal Saline|Ropivacaine 0,75%, 2ml (15mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus
16178453|NCT01558713|Drug|Levobupivacaine- Fentanyl- Normal Saline|Levo-bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus, Normal Saline 0,9%, 10ml bolus
16178454|NCT01558713|Drug|Bupivacaine + Fentanyl|Bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus
16178455|NCT01558713|Drug|Ropivacaine + Fentanyl|Ropivacaine 0,75%, 2ml (15mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus.
16178456|NCT01558713|Drug|Levobupivacaine + Fentanyl|Levo-bupivacaine 0,5%, 2ml (10mg)bolus, Fentanyl 50μg/ml, 0,2ml (10 μg)bolus
16178457|NCT01558700|Drug|Duloxetine|Duloxetine capsule 30mg once a day for one week, then 60mg once a day for 15 weeks, then 30mg once a day for one week.
16178458|NCT01558700|Drug|Sugar pill|Matching capsule given once a day for a total of 17 weeks.
16178459|NCT01558687|Drug|Drug (including placebo)|"Subjects will receive cilengitide monotherapy for 2 weeks (Weeks 1 and 2); thereafter, cilengitide will be given in combination with the standard treatment regimen during Weeks 3 to 36. The standard combination treatment of radiotherapy (RTX) plus Temolozomide (TMZ) will be administered for a maximum of 6 weeks (Weeks 3 to 8), followed by TMZ maintenance treatment starting 4 weeks after RTX (i.e., Week 13) for up to 6 cycles, 4 weeks per cycle.
~Cilengitide monotherapy treatment will be given to subjects in Group A for another 10 months as maintenance treatment (Weeks 37 to 78). Subjects in Group A may continue to receive cilengitide maintenance treatment beyond 10 months (beyond Week 78) until occurrence of progressive disease (PD) or unacceptable toxicity, or withdrawal for any other reason. A 28-day safety follow-up will be performed after the last dose of cilengitide."
16178460|NCT01558687|Other|Standard therapy|In the first two weeks, treatment of subjects in Group B will be in line with the SoC. Thereafter the standard combination treatment of radiotherapy (RTX) plus Temolozomide (TMZ) will be administered for a maximum of 6 weeks (Weeks 3 to 8), followed by TMZ maintenance treatment starting 4 weeks after RTX (i.e., Week 13) for up to 6 cycles, 4 weeks per cycle.
16178461|NCT01558674|Drug|MK-7145|
16178462|NCT01558674|Drug|Furosemide|
16178463|NCT01558674|Drug|Torsemide|
16178464|NCT01558661|Drug|AG-013736 (AXITINIB)|All eligible patients will receive a starting axitinib dose of 5 mg twice daily (BID) taken orally in 4-week (28-day) cycles. Patients who tolerate axitinib with no adverse events related to study drug above CTCAE v. 4.0 Grade 2 for a consecutive 2-week period may have their dose increased by one dose level according to the discretion of the treating physician (NOT allowed for patients with blood pressure (BP) > 150/90 mm Hg or who are receiving antihypertensive medication). This dose escalation is not mandatory. RECIST v1.1 tumor assessments will be made at baseline (CT or MRI) and then approximately every 2 cycles (or every 8 weeks (+/- 1 week)). After 10 months, imaging will be done every 3 cycles (or every 12 weeks (+/- 1 week)). Patients may remain on study until progression of disease or unacceptable toxicity.
16178501|NCT01558414|Procedure|Conventional laparoscopy|Minimally invasive cholecystectomy through the conventional laparoscopic approach using 3 ports (one 11-cm umbilical port and two accessory 5-mm ports).
16178540|NCT01558128|Procedure|Cardioversion|Cardioversion done if atrial fibrillation continues following 24 hour infusion of amiodarone. Cardioversion done following hospital protocol.
16184304|NCT01514201|Other|Pharmacological Study|Correlative studies
16178465|NCT01558648|Behavioral|Quality of Life instruments, FACT-E, Symptom Assessment Scale, Brief Pain Inventory and Daily Analgesic Log|Initial pre-operative assessment post-operative assessment in-hospital assessment at first post-operative visit (clinic visits, or by telephone or mail) assessments at 4, 8, 12, 18, and 24 months post-operatively (+/- 2 month window). For patients who have their surgery delayed, they may be asked to complete another, more updated set of pre-surgery surveys. For the dysphagia score and CT Scan vs EUS subset will be a dysphagia questionnaire, administered at the time of the initial clinic visit.
16178466|NCT01558648|Behavioral|Quality of Life instruments, FACT-E, Symptom Assessment Scale, Brief Pain Inventory and Daily Analgesic Log|Initial pre-operative assessment post-operative assessment in-hospital assessment at first post-operative visit (clinic visits, or by telephone or mail) assessments at 4, 8, 12, 18, and 24 months post-operatively (+/- 2 month window). For patients who have their surgery delayed, they may be asked to complete another, more updated set of pre-surgery surveys. For the dysphagia score and CT Scan vs EUS subset will be a dysphagia questionnaire, administered at the time of the initial clinic visit.
16178467|NCT01558635|Device|Cardioblate CryoFlex Surgical Ablation|Longstanding persistent AF was treated with the Cox Cryo Maze III procedure During mitral valve surgery a surgical ablation was performed, using the Cardioblate CryoFlex Surgical Ablation System. In addition, the Medtronic Reveal XT Insertable Cardiac Monitor, was implanted.
16178468|NCT01558635|Procedure|Mitral Valve surgery|Classic mitral valve surgery was performed
16178469|NCT01558635|Device|Medtronic Reveal XT Insertable Cardiac Monitor|During the procedure, a Medtronic Reveal XT Insertable Cardiac Monitor was implanted to monitor episodes of AF during follow-up period
16178470|NCT01558635|Procedure|MAZE III|Longstanding persistent AF was treated with the Cox Cryo Maze III procedure
16178471|NCT01558622|Drug|dexketoprofen trometamol|50mg intravenous infusion
16178472|NCT01558622|Drug|tramadol hydrochloride|100mg intravenous infusion
16178473|NCT01558622|Drug|pethidine hydrochloride|50mg intravenous infusion
16178474|NCT01558622|Drug|dexketoprofen trometamol + tramadol hydrochloride|intravenous infusion of 50mg dexketoprofen trometamol + 100mg tramadol hydrochloride
16178475|NCT01558622|Drug|dexketoprofen trometamol + pethidine hydrochloride|intravenous infusion of 50mg dexketoprofen trometamol + 50mg pethidine hydrochloride
16178476|NCT01558622|Drug|vitamin c|500mg intravenous infusion
16178477|NCT01558596|Procedure|Preconditioning|Blood pressure cuff inflated to 200 mmHg in the upper extremity for 5 minutes to cause forearm ischemia by external compression of the brachial artery. This will be followed by 5 minutes of cuff deflation to allow for preperfusion. The ischemia-reperfusion cycle will be repeated 3 times for a total duration of 30 minutes, equally divided between ischemia and reperfusion.
16178478|NCT01558596|Procedure|Control|Blood pressure cuff inflated to 40-50 mmHg in the upper extremity
16178479|NCT01558583|Other|Rating and Ranking Task|Individuals who are randomized to the rating and raking arm will be asked to complete an informational task in a rating and ranking format. The task will help individuals clarify their opinions and preferences regarding colon cancer and prostate cancer screening.
16178480|NCT01558583|Other|Discrete Choice Task|Individuals who are randomized to the rating and raking arm will be asked to complete an informational task in a discrete choice format. The task will help individuals clarify their opinions and preferences regarding colon cancer and prostate cancer screening.
16178481|NCT01558583|Other|Balance Sheet Task|Individuals who are randomized to the rating and raking arm will be asked to complete an informational task in a balance sheet format. The task will help individuals clarify their opinions and preferences regarding colon cancer and prostate cancer screening.
16178482|NCT01558570|Procedure|Blood Draw|One time blood draw
16178483|NCT01558557|Other|Gluten Free Diet|Participants will be given a Gluten Free Diet for 2 weeks
16178484|NCT01558544|Procedure|surgery to remove ovaries or high dose chemotherapy|oophorectomy to remove a disease ovary.
16178485|NCT01558531|Device|DEB|paclitaxel-eluting balloon angioplasty
16178486|NCT01558531|Device|POBA|conventional balloon angioplasty
16178487|NCT01558505|Device|PEB|paclitaxel-eluting balloon angioplasty
16178488|NCT01558505|Device|POBA|conventional balloon angioplasty
16178489|NCT01558492|Drug|Carboplatin|AUC = 5 intravenously (IV) on day 1 of a 28 day cycle
16178490|NCT01558492|Drug|Paclitaxel|80 mg/m2 intravenously (IV) weekly on days 1, 8, and 15 of a 28 day cycle
16178491|NCT01558466|Drug|Sildenafil|50 mg tablet will be thoroughly crushed into powder form and diluted in 10 ml ora base suspension syrup agent and a dilution will be performed to prepare 5 mg/ml. All doses required for 48 hours will be available; solutions will be stored at 2-8 degrees C where solution should be stable for at least a month.
16178492|NCT01558466|Drug|diluent|The placebo will have an equal volume of diluent - Orabase syrup of the same colour and viscosity as the active comparator. Infants in this group will receive normal saline as placebo every 6 hours
16178493|NCT01558453|Drug|Oxaliplatin|"Oxaliplatin will be administered in a 130 mg/m² dose, 2 hour IV infusion, once every 3 weeks. Each cycle will last 3 weeks, or 21 days. Drug will be administered till progression disease or untolerable adverse event.
~NOTE: patients with ≤ 12 months old will receive a 4,3 mg/kg dese (based on a 30 kg/m² conversion; i.e: in a 130 mg/m² dose, divided by 30)."
16178494|NCT01558440|Dietary Supplement|Infant Formula|A diet that is being fed to the young infants.
16178495|NCT01558440|Dietary Supplement|F-100|• F-100: The estimated PRSL for F-100 is 360 mOsm/L or 53 mOsm/100kcal and in a young infant growing normally this could exceed the excretory capacity of the kidney with the risk of hypernatremic dehydration. In the rehabilitation phase, however, severely malnourished children grow extremely rapidly and the potential solutes (e.g. protein, potassium) are deposited in lean tissue and do not present to the kidney for excretion. Thus, although the potential RSL is high, this has been assumed to be a theoretical risk for rapidly growing infants
16178496|NCT01558440|Dietary Supplement|Diluted F-100|300 ml of water is added to 1000 ml of f-100
16178497|NCT01558427|Procedure|Surveillance|Active clinical surveillance
16178498|NCT01558427|Procedure|Salvage treatment|Surgical removal of metastases, or stereotactic body radiotherapy of metastases.
16178499|NCT01558414|Procedure|SILS Cholecystectomy|Cholecystectomy performed by Single Incision Laparoscopic Surgery with the SILS TM device
16178580|NCT01557816|Drug|Placebo|Placebo for seven days given BID during either of the 2 treatment periods.
16178502|NCT01558401|Other|Physical activity program|The activities are done in groups of no more than 25 individuals; these activities are standardized and agreed upon by the research team, which hold monthly meetings to conduct the study. Each physical activity session consists of 8-10 minutes of exercises aimed at stretching the major muscle groups (pectoral muscles, latissimus dorsi, cervical paravertebral, and posterior and anterior thigh muscles); 9 minutes of aerobic endurance activity (march/fast walk); 7-10 minutes of adapted strength exercises, power, and endurance training; 14-16 minutes of coordination, agility, and flexibility exercises, and 5-7 minutes of respiratory and relaxation exercises.
16178503|NCT01558388|Drug|Lactobacillus acidophilus|Lactobacillus acidophilus 500 million colony-forming units/tablets. One vaginal tablet daily for 10 days.
16178504|NCT01558388|Drug|Placebo|One vaginal tablet daily for 10 days.
16178505|NCT01558375|Drug|Water for injection|Placebo syringes will contain 0.67ml of sterile water for injection. This will be injecteda daily for 12 weeks.
16178506|NCT01558375|Drug|Anakinra|Anakinra will be supplied in single use pre-filed glass syringes with 27-gauge needles. Anakinra syringe will contain 100mg of anakinra at a volume of 0.67 ml. This will be injected subcutaneously daily for 12 weeks.
16178507|NCT01558362|Drug|123I-CMICE-013|2 intravenous doses of drug will be given one week apart. Doses will be equivalent to 1 rest dose and 1 stress dose. Serial nuclear imaging will follow dose injections.
16178508|NCT01558336|Drug|praziquantel|praziquantel 40 mg/kg oral tablets
16178509|NCT01558323|Drug|LCQ908|Participants will receive a single oral dose of LCQ908
16178510|NCT01558310|Drug|Ustekinumab|Subjects will be randomized into one of two groups. Group A will receive ustekinumab at week 0, 4, 16, 28, and week 40 and placebo at week 12 and 52. Group B will receive placebo at Week 0 and 4, and ustekinumab at weeks 12, 16, 28, 40 and 52. The subjects when assigned to ustekinumab, depending on body weight, will receive either 45mg or 90mg ustekinumab doses
16178511|NCT01558310|Drug|Placebo|Subjects will be randomized into one of two groups. Group A will receive ustekinumab at week 0, 4, 16, 28, and week 40 and placebo at week 12 and 52. The subjects when assigned to ustekinumab, depending on body weight, will receive either 45mg or 90mg ustekinumab doses
16178512|NCT01558297|Behavioral|Motivational Interviewing|5 sessions of motivational interviewing over a period of 3 months.
16178513|NCT01558297|Behavioral|Nutritional Counseling|5 sessions of nutritional counseling over a period of 3 months.
16178514|NCT01558297|Behavioral|Treatment as usual with primary care physician|Participants will be encouraged to continue their care with their primary care physician.
16178515|NCT01558284|Drug|Neu-P11|Neu-P11 is a new Melatonin receptor-, Serotonin 5-HT- 1A and 5-HT- 1D - agonist and a serotonin 5-HT- 2B - antagonist
16178516|NCT01558284|Drug|Placebo|Placebo
16178517|NCT01558271|Drug|LY2189265|
16178518|NCT01558271|Drug|Placebo|
16178519|NCT01558271|Drug|Liraglutide|
16178520|NCT01558258|Behavioral|Mindful Awareness practices (MAPs)|Mindfulness meditation-based intervention, is a 6-week program adapted from an existing program at Mindfulness Awareness Research Center(MARC),UCLA.
16178521|NCT01558245|Drug|tissue kallikrein|Human urinary kallidinogenase can transform kininogen to bradykinin (kinin) and vasodilatory factors (kallidin)
16178522|NCT01558232|Device|Tibion Bionic Leg|The Tibion Bionic Leg is used as an adjunct in post-stroke and post-operative rehabilitative physical therapy. The leg is a lightweight, wearable, portable, battery-powered, motorized leg orthosis that provides active assistance and resistance to lower limb movement during walking, stair ascent and descent, and transfers from sitting to standing (and standing to sitting).
16178523|NCT01558219|Drug|cabacitaxel|Jevtana® (cabazitaxel) 16 mg/m2 IV in 1 hour on day 1 given every second week
16178524|NCT01558206|Other|Pulmonary artery CT Angiography|Performing Pulmonary artery CT Angiography for patients with signs and symptoms in favor of PTE.
16178525|NCT01558206|Other|Emergency Bedside Ultrasonography of chest|Performing Emergency Bedside Ultrasonography of chest at the time of presentation for patients with signs and symptoms in favor of PTE.
16178526|NCT01558193|Dietary Supplement|Placebo|"Placebo for DHA of identical appearance - based on olive oil
~Placebo for vitamins/minerals of identical appearance"
16178527|NCT01558193|Dietary Supplement|Multi-vitamin/mineral|Each active tablet contained vitamins A (800µg); B1 (1.4mg); B2 (1.75mg); B6 (2mg); B12 (2.5mg); biotin 62.5 µg; folic acid 200 µg; niacin 20 mg; C (100mg); D (5µg); E (15mg); K (30µg); pantothenic acid (7.5 mg). In addition several minerals were administered: calcium (162mg); phosphorus (125mg); magnesium (100mg); potassium (40mg); chloride (36.3mg); iron (5mg); iodine (100µg); copper (500µg); manganese (2mg); chromium (40µg); molybdenum (50µg); selenium (30µg); zinc (5mg) as well as lutein (500 µg) . The placebo capsule was identical in color, size and appearance.
16178528|NCT01558193|Dietary Supplement|Docosahexaenoic acid|22:6 (n-3) docosahexaenoic each capsule contained 224.2mg and three were taken per day
16178529|NCT01558193|Dietary Supplement|DHA plus vitamins/minerals|The DHA and vitamin/mineral supplements are as above
16178530|NCT01558180|Behavioral|Telephone Care Management|series of phone calls from registered nurse to discuss behavioral suggestions for pediatric insomnia
16178531|NCT01558180|Behavioral|Usual Care|educational handouts on pediatric insomnia
16178532|NCT01558167|Drug|Bendamustine, Rituximab, Lenalidomide|"Bendamustine: 50 mg/m2, i.v., day 1+2
~Rituximab: Cycle 1: 375 mg/m2, i.v. day 0; Cycle 2-6: 500mg/m2, i.v., day 1
~Lenalidomide:
~Dose level 1: Cycle 1-6: 2,5mg p.o., d1-28
~Dose level 2: Cycle 1: 2,5mg p.o., d1-28; Cycle 2-6: 5mg p.o., d1-28
~Dose level 3: Cycle 1: 2,5mg p.o., d1-28; Cycle 2:5mg p.o., d1-28; Cycle 3-6: 10 mg p.o., d1-28
~Dose level 4: Cycle 1: 2,5mg p.o., d1-28; Cycle 2:5mg p.o., d1-28; Cycle 3: 10 mg p.o.,d1-28, Cycle 4-6: 15 mg p.o.,d1-28
~Dose level 5: maximal tolerated dose"
16178533|NCT01558154|Drug|Chinese herbs|Chinese herbs special for depression
16178534|NCT01558154|Procedure|acupuncture|six acupuncture point including DU20, EX HN3, EX HN1, PC6,HT7,SP6,special for depression
16178535|NCT01558154|Other|Psychotherapy|Thought Imprint Psychotherapy under lower Resistance State
16178536|NCT01558154|Device|Transcranial magnetic stimulation|Give magnetic stimulation at head
16178537|NCT01558141|Other|Aspiration without flushing follicles with culture media|Aspiration without flushing follicles with culture media.
16178538|NCT01558141|Other|Follicular Flushing|Flushing follicles with embryo culture media prior to aspiration.
16178539|NCT01558128|Drug|Amiodarone|Bolus given 150mg IV, then IV drip 1mg per hour infused for 6 hours, 0.5mg per hour infused for 18 hours.
16178541|NCT01558115|Drug|Denosumab|"The dose of denosumab is 60 mg every 6 months by subcutaneous injection.
~The 52 subjects will be randomly allocated (2:1) into treatment and placebo arms with the placebo group receiving a subcutaneous injection of vehicle in year 1. In year 2, those who were allocated to the study drug in year 1 will continue in year 2. Those who were allocated to placebo in year 1 will be crossed over to study drug in year 2.
~Group # 1 (35 patients): Receive active drug for year 1 and year 2 of the study
~Group #2 (17 patients): Receive placebo for year 1 and active drug for year 2 of the study"
16178542|NCT01558115|Other|Placebo|"The dose of denosumab is 60 mg every 6 months by subcutaneous injection. The placebo group will receive vehicle injections at the same time interval.
~The 52 subjects will be randomly allocated (2:1) into treatment and placebo arms with the placebo group receiving a subcutaneous injection of vehicle in year 1. In year 2, those who were allocated to the study drug in year 1 will continue in year 2. Those who were allocated to placebo in year 1 will be crossed over to study drug in year 2.
~Group # 1 (35 patients): Receive active drug for year 1 and year 2 of the study
~Group #2 (17 patients): Receive placebo for year 1 and active drug for year 2 of the study"
16178543|NCT01558089|Drug|etanercept|according to SmPC and clinical practice
16178544|NCT01558089|Drug|methotrexate|according to SmPC and clinical practice
16178545|NCT01558063|Drug|Ketamine|Single dose of 0.1, 0.2, 0.3, 0.4 or 0.5 mg/kg of ketamine given intravenously over 40 minutes.
16178546|NCT01558063|Drug|Saline|Single infusion of saline given intravenously over 40 minutes.
16178547|NCT01558063|Procedure|Magnetic Resonance Imaging (MRI)|90-minute scan during the 40-minute infusion.
16178548|NCT01558050|Dietary Supplement|red rice supplement|patricipants take a red rice supplement or placebo daily for 8 weeks
16178549|NCT01558011|Drug|Capecitabine, Oxaliplatin, Docetaxel|"Capecitabine: 500 mg film coated tablets; Oxaliplatin: 50 mg/ 10 ml; Docetaxel: 20 mg / 0.5ml vial.
~Dosing Regimena: total of 6 cycles of modified XELOX regimen repeats every 2 weeks, and followed by 4 cycles of TX repeats every 3 weeks. After 10 cycles of treatment, patients may continue to treat with either of the regimen, preferably the one having the best efficacy."
16178550|NCT01557998|Behavioral|POC CD4 and Peer Case Management|HIV-positives will receive prevention with positives (PwP) counseling and point of care CD4 counts. Those with CD4 <500/μL will be assigned a peer case manager to link the person to ART at study-participating HIV clinics, support ART and PwP adherence and care retention.
16178551|NCT01557998|Drug|HCV+PWID|Deliver direct acting antiviral (DAA) regimens for HCV+PWID. We will treat both active and inactive confirmed HCV viremic PWID from either Medication Assisted Treatment (MAT) clinics in Nairobi, Mombasa, and Malindi, Kenya or Collaborating partners' sites/Drop-in Centers (DICs) in Mombasa and Mtwapa, Kenya with direct acting antiviral (DAA) regimens. The mode of treatment delivery will be Directly Observed Therapy (DOT) for 84 consecutive doses (one dose per day). All participants will receive pre, post and ongoing counseling as per study protocol.
16178552|NCT01557998|Behavioral|Control - No intervention|
16178553|NCT01557985|Drug|Bupivacaine|The volume of Bupivacaine per block will be 0.5 mL at 0.125%.
16178554|NCT01557972|Procedure|Blood pressure measurement based on HBP or CBP|To clarify which of HBP or CBP provides the stronger prediction power for the outcomes.
16178555|NCT01557972|Procedure|Blood pressure measurement based on HBP or CBP|To clarify which of HBP or CBP provides the stronger predictive power for the outcomes
16178556|NCT01557959|Drug|cisplatin|Given IV
16178557|NCT01557959|Biological|pegfilgrastim|Given SC
16178558|NCT01557959|Drug|erlotinib hydrochloride|Given PO
16178559|NCT01557959|Other|laboratory biomarker analysis|Optional correlative study
16178560|NCT01557959|Genetic|polymorphism analysis|Correlative study
16178561|NCT01557959|Other|pharmacogenomic studies|Correlative study
16178562|NCT01557959|Genetic|genetic linkage analysis|Correlative study
16178563|NCT01557959|Drug|docetaxel|Given IV
16178564|NCT01557946|Drug|citalopram|citalopram 20-40 mg daily
16178565|NCT01557933|Other|No interventions will be used|No interventions will be used
16178566|NCT01557920|Drug|Propofol|Propofol administration for induction of general anesthesia. Administration will be performed IV, using a Target Controlled Induction Pump.
16178567|NCT01557920|Drug|Sevoflurane|Sevoflurane will be administered via mask inhalation to achieve anesthesia.
16178568|NCT01557907|Device|Subcutaneous delivery via Medtronic Quick-Set|Infusion rates and pre-meal bolus doses will be based on subjects known daily infusion rate and subject's reported insulin to carbohydrate ratio.
16178569|NCT01557907|Device|Intradermal delivery via the BD Research Catheter Set|Infusion rates and pre-meal bolus doses will be based on subjects known daily infusion rate and subject's reported insulin to carbohydrate ratio.
16178570|NCT01557894|Other|iSOFIE|Cognitive - Behavioral: Internet-administrated CBT for social phobia that contains 9 self-help text modules and exercises (i.e., behavioral experiments)
16178571|NCT01557881|Device|magnetic resonance imaging with positron emission tomography scanning|University Hospitals Seidman Cancer Center [SCC] will house the Philips Ingenuity TF PET/MR, which is a hybrid scanner that merges magnetic resonance imaging with positron emission tomography scanning. University Hospitals is one of only five hospitals in the world with this technology. The PET/MRI system consists of two imaging scanners used sequentially as in PET/CT. The 3Tesla MRI component provides the high resolution that is necessary for soft tissue contrast and functional information on perfusion, diffusion, or metabolism. PET provides information about cellular metabolism and receptor status.
16178572|NCT01557868|Device|hylan G-F 20|Three 2 cc injections at weekly intervals
16178573|NCT01557868|Device|1% sodium hyaluronate|Three 2 cc injections at weekly intervals
16178574|NCT01557855|Diagnostic Test|Corus CAD (ASGES)|Age/Sex/Gene Expression Score - ASGES
16178575|NCT01557842|Drug|Drug Treatment|Class I and III antiarrhythmic drug treatment.
16178576|NCT01557842|Device|Catheter Ablation|Radiofrequency catheter ablation and Class I and III antiarrhythmic drug treatment.
16178577|NCT01557829|Device|Posterior lumbar interbody fusion with a PEEK cage|PEEK cage suitable for oblique placement in the lumbar spine
16178578|NCT01557829|Device|Posterior lumbar interbody fusion with a Valeo OL cage|Posterior lumbar interbody fusion with a single Valeo OL ceramic cage.
16178579|NCT01557816|Drug|Naproxen|Naproxen for 7 days (3 days at 250 mg BID followed by 4 days at 500 mg BID) during either of the 2 treatment periods.
16178581|NCT01557790|Radiation|Proton Radiation Therapy|
16178585|NCT01557751|Genetic|Whole blood for genotyping|This study requires genotyping by extracting DNA from blood sample. A blood sample will be drawn once during visit 2 (day of surgery) or any other time prior to that after the signing of informed consent. Four vacutainers of which hold 8.5 mL will be drawn during this time totaling approximately 34 mL of blood which completes the genomic sampling portion of the study.
16178586|NCT01557738|Dietary Supplement|High Flavanol Trial|The experimental trial (high flavanol content) will involve the consumption of a beverage containing about 1000mg of cocoa flavanols.
16178587|NCT01557738|Dietary Supplement|Low Flavanol Trial|The placebo trial (low flavanol content) will involve the consumption of a beverage containing 75 mg of cocoa flavanols.
16178588|NCT01557738|Dietary Supplement|High Flavanol Trial; long-term|The experimental trial (high flavanol content) will involve the daily consumption of a beverage containing about 1000mg of cocoa flavanols for 4 weeks. Subjects will be provided with 28 packets of the beverage to take home with them.
16178589|NCT01557738|Dietary Supplement|Low Flavanol Trial; long-term effects|The placebo trial (low flavanol content) will involve the daily consumption of a beverage containing 75 mg of cocoa flavanols for 4 weeks. Subjects will be provided with 28 packets to take home with them.
16178590|NCT01557712|Drug|ketamine venlafaxine|"After a washout period of 7 days of psychotropic medications with the exception of cyamemazine and hydroxyzine:
~Intravenous injection on day 0 to 0.5 mg / kg of ketamine
~D0 to D4: 75 mg of venlafaxine
~D4 to D14: 150 mg per day of venlafaxine
~D14 to D42: 150 mg daily of venlafaxine to 375 mg per day of venlafaxine if patient not responder"
16178591|NCT01557712|Drug|Venlafaxine|"After a washout period of 7 days of psychotropic medications with the exception of cyamemazine and hydroxyzine:
~Intravenous injection on day 0 to 0.5 mg / kg of placebo (saline serum)
~D0 to D4: 75 mg of venlafaxine
~D4 to D14: 150 mg per day of venlafaxine
~D14 to D42: 150 mg daily of venlafaxine to 375 mg per day of venlafaxine if patient not responder"
16178592|NCT01557699|Biological|PMV via Puffhaler® device|The vaccine will be administered via a Puffhaler® device. A single dose of 10 mg of PMV (dry powder measles vaccine) will be used.
16178593|NCT01557699|Biological|PMV via SoloventTM device|The vaccine will be administered via SoloventTM device. A single dose of 10 mg of PMV (dry powder measles vaccine) will be used.
16178594|NCT01557699|Biological|Licensed Subcutaneous Measles Vaccine|This is a licensed formulation containing the live attenuated Edmonston Zagreb virus. A single dose of 0.5 ml will be given subcutaneously.
16178595|NCT01557686|Behavioral|Health counseling and exercise|The intervention is initiated during chemotherapy treatment (consolidation) in the outpatient clinic and continues for 6 weeks. The intervention is a three hour/wk supervised in-hospital programme of aerobic (stationary cycle) and functional muscle training, progressive relaxation training, nutrition supplement (protein and carbohydrate) immediately after training and two health-promoting counseling sessions - Further, patients are fitted with a step counter pedometer.
16178596|NCT01557673|Dietary Supplement|NG bolus feeding over 5 min|Tube bolus (TB): 400 ml of Resource® Energy Vanilla nutrient drink, Societe des Produits Nestle S.A., administered via the NG tube over 5 min.
16178597|NCT01557673|Dietary Supplement|Continuous NG feeding over 4 h|Continuous tube drip feeding (TD): 400 ml of Resource® Energy Vanilla nutrient drink, Societe des Produits Nestle S.A., delivered via feeding pump through the NG tube over 4 h.
16178598|NCT01557660|Drug|inhaled treprostinil|0.6mg/mL inhalation solution, up to 12 breaths four times a day
16178599|NCT01557647|Drug|Inhaled treprostinil|0.6mg/mL treprostinil for inhalation solution. Titrated up to 12 breaths QID.
16178600|NCT01557647|Drug|Placebo|placebo inhalation solution
16178601|NCT01557634|Procedure|Overnight closed-loop insulin delivery|Basal insulin infusion rates on insulin pump will be directed by MPC algorithm using diluted versus non-diluted insulin
16178602|NCT01557621|Behavioral|Collaborative Pop-Based R/R: Phone/Mail Group|Within each county, half of patients will be randomized to a phone/mail group (2 auto-dialer calls and 2 postcards) and the other half of patients will be put in a mail-only group (4 mailings). The following collaborative approaches will be utilized: patient addresses and phone numbers will be updated prior to recall for electronic Flat File Format practices; all notices to parents (auto-dialer calls and mailings) will appear to come both from the local public health department and providers who choose to have their name listed; all bad addresses and phone numbers will be updated by calling the last provider of care. Up to 4 notices will be sent to parents of children who are still not up to date for recommended immunizations.
16178603|NCT01557621|Behavioral|Collaborative Pop-Based R/R: Mail-Only Group|Parents will receive up to four mailings if their child appears in need of immunizations according to CIIS. The Collaborative method is the same as in the auto-dialer/mail group; however patients in this group will not receive telephone calls.
16178604|NCT01557621|Behavioral|Practice-based Recall|All practices will receive training on how to conduct practice-based recall using CIIS and educational materials to use within their practices to promote compliance with the infant vaccination schedule. Individual practices will make their own decisions about the extent to which they follow the recommendations and implement recall within their practice. Although the study team will not provide them with any additional interventions, we will track any other interventions they independently do (websites, newsletters, telephone) in order to assess the effect of these additional interventions.
16178605|NCT01557608|Procedure|Photon stimulation|The LED diode wavelength chosen for this study is 870 nanometers. When activated, the photon stimulator is preset to deliver 1800 Joules in a 7 minute treatment period. Patients will receive a total of 8 treatments, to both feet simultaneously, within a 14 day period depending on their schedule.
16178606|NCT01557608|Procedure|Placebo treatment|"For patients who receive the placebo treatment, the electronic control unit will be deactivated (i.e., no energy is delivered) even though the indicator lights will be illuminated when the power switch is turned to the ON position. Using this procedure, the research nurse who administers the treatments and collects the outcome data will be blinded to the patients' group assignment."
16178670|NCT01557153|Drug|Amlodipine|Starting dose will be 5mg/day for four weeks. All participants will be titrated up to the maximum of 10mg/day after 4 weeks. If they do not tolerate this dose, it will be reduced again to 5mg/day and they will continue on their maximum tolerated dose for 12 weeks (for a total of 16 weeks of medication or placebo)
16178768|NCT01556347|Drug|Bortezomib, Thymoglobulin, Rituximab, Gamimune N, (IVIG), Plasmapheresis|
16178769|NCT01556334|Drug|Azithromycin|Azithromycin 1g po
16178607|NCT01557595|Device|Polarized glasses designed to filter out blue light|"Participants will be given polarized glasses (yellow sun- glasses) which filter out blue light to wear only from sundown until bedtime for two weeks. They will be instructed to turn off fluorescent lights and only use household lamps for evening activities. They will be instructed not to drive while wearing the glasses. In addition to the oral instructions, they will also be given a written Instruction Sheet. Any oral insomnia agent will be held throughout the study, otherwise they are to follow their usual evening routines. This is an alternative treatment already in use in Dr. Fargason's practice for those patients who don't want to take sleep medications. This research focuses on the effectiveness of this treatment and involves questionnaires to do so."
16178608|NCT01557582|Device|Ventripoint Medical System|"The subjects will undergo a 2D echocardiography according to standard of care. An additional 5 - 10 minutes of scanning using VMS transducer attached to the echocardiography system to acquire images for 3-D reconstruction is required.
~Within one day of the VMS image acquisition the subjects will also undergo cMRI according to hospital standards of care plus an additional 5 minutes to capture the PSSS required images."
16178609|NCT01557569|Drug|Atomoxetine|During the first 2 weeks and three days the dose of atomoxetine will be titrated up starting with 20 mg/day for first 3 days, 36 mg/day for next 4 days, 50 mg/day for next 3 days, and finally 80 mg/day until the final day of the study (week 10, day 7)
16178610|NCT01557569|Drug|placebo|participants in this group will receive 1 dose of placebo daily for the entire 10-weeks.
16178611|NCT01557543|Other|Cell Therapy|Intramyocardial Injection of BMSCs
16178612|NCT01557517|Drug|Clobetasol Oral Rinse|Cycle= up to 4 weeks Patients will rinse oral cavity with 10cc of clobetasol 0.05% oral rinse for 2 minutes 3 times a day.
16178613|NCT01557517|Drug|Placebo oral rinse|Patients will rinse oral cavity with 10cc of placebo oral rinse for 2 minutes 3 times a day.
16178614|NCT01557504|Drug|Sitagliptin/metformin XR|Fixed dose combination tablet of immediate-release sitagliptin 50 mg and extended-release (XR) metformin 1000 mg (total daily dose, sitagliptin 100 mg and metformin XR 2000 mg).
16178615|NCT01557504|Drug|Placebo|Matching placebo to fixed dose combination tablet of sitagliptin and metformin. Matching placebo tablets are same size, shape and color as the active product, but do not contain any markings.
16178616|NCT01557504|Drug|Metformin|Concomitant use of metformin is permitted during the study provided the participant has been receiving a stable metformin dose for at least 12 weeks prior to the dose of study drug. Administration of metformin will be withheld for 24 hours prior to study drug administration and for 24 hours postdose.
16178617|NCT01557504|Drug|Thyroid hormone|Concomitant use of thyroid hormone (eg, levothyroxine) is permitted during the study provided the participant has been receiving a stable dose for at least 12 weeks prior to study drug administration and is euthyroid as documented by thyroid stimulating hormone testing at prestudy. Administration of thyroid hormone will be withheld for 24 hours prior to study drug administration and for 24 hours postdose.
16178618|NCT01557491|Procedure|Straight Incision|The incision will be made at a 90 degree angle to the surface of the scalp
16178619|NCT01557491|Procedure|Bevelled Incision|The Incision will be made at a 45 degree angle to the surface of the scalp.
16178620|NCT01557478|Drug|Melatonin|20 mg melatonin gelatin capsule (1) taken orally after 21:00 hours each night throughout the study
16178621|NCT01557478|Drug|match placebo|placebo gelatin capsule (1) taken orally after 21:00 hours each night throughout the study
16178622|NCT01557452|Drug|Givinostat|ready-to-use oral suspension, administered in fed condition and on a outpatient basis, especially intended for paediatric patients
16178623|NCT01557439|Drug|Levocetirizine Dihydrochloride 5 mg Tablets|A single oral dose of Levocetirizine Dihydrochloride 5 mg Tablets
16178624|NCT01557426|Other|Ultrasound|A linear ultrasound transducer will be used with ultrasound gel to obtain an image of subcutaneous structures and tissues over the involved body site. Ultrasound video will be recorded whenever possible, however studies that are not recorded will still be included. Video recording will be initiated once the desired image is obtained. Appropriate measurements will be made and views identified using the features of the ultrasound machine. Scanning of the contralateral body segment will then be performed. The ultrasound probe will be thoroughly cleaned and disinfected between ultrasound scans.
16178625|NCT01557413|Procedure|Intramedullary nail|the fracture was reduced and fix by an intramedullary humeral nail (Multilock, SYNTHES, Switzerland) using an open surgery. An anterolateral approach will be performed, the patient sit in beach chair position under general anesthesia. If required additional sutures will be authorized to fix the tuberosities.
16178626|NCT01557413|Procedure|Locked plate|the fracture was reduced and fix by a locking plate using an open surgery (SURFIX, Integra, France). A deltopectoral approach will be performed, the patient sit in beach position under general anesthesia. If required, additional sutures will be authorized to fix the tuberosities.
16178627|NCT01557400|Drug|Ataluren|Oral powder for suspension
16178628|NCT01557387|Other|Endoscopic techniques|All patients will undergo non-invasive endoscopic techniques considered standard of care in surveillance for dysplasia
16178629|NCT01557374|Drug|Tocilizumab, Abatacept|Tocilizumab: Roactemra 4-8 mg/kg/month and 162 mg/week Abatacept: Orencia 500-1000 mg/month and 125 mg/week
16178630|NCT01557374|Drug|Decrease Tocilizumab, Abatacept|"The decrease pattern is established on 4 consecutive stages :
~IV Abatacept (500-1000 mg/month) and Tocilizumab(4-8 mg/kg/month):
~Stage 0 : Perfusion /30 days Stage 1 :Perfusion/45 days Stage 2 :Perfusion/60 days Stage 3 :Perfusion/90 days Stage 4 :Stop
~SC Abatacept (125 mg/week) and Tocilizumab (162 mg/week):
~Stage 0 :Injection/7 days Stage 1 :Injection/10 days Stage 2 :Injection/14 days Stage 3 :Injection/21 days Stage 4 :Stop
~If DAS 28 ≤ 2,6 (remission DAS persistent) on trimestrial visit: transfer to next stage for 3 months before next evaluation.
~If DAS 28 > 2,6 et ≤ 3,2 (weak activity) : maintain ongoing stage
~If DAS 28 > 3,2 : return to previous stage, (relapse according to European expert consensus)
~In the case of relapse while the patient is in stage 0, the therapy modification is left to the investigator's free will, but the patient will be followed till the end of the study."
16178631|NCT01557361|Other|Accelerated RRT initiation|A dialysis catheter will be placed and RRT initiated as soon as possible and within 12 hours of eligibility. This 12 hour window includes the time needed to obtain consent.
16178702|NCT01556945|Other|AS02 adjuvant alone|AS02 adjuvant contains 50 μg monophosphoryl lipid A (MPL) and 50 μg Quillaja saponaria 21 (QS-21), 250 μl of SB62 (oil/water emulsion) in phosphate buffered saline (PBS) per volume of 0.5 ml.
16178632|NCT01557361|Other|Standard RRT initiation|"Patients will be carefully followed over a period of 7 days to identify potential indications for RRT. The trial team will ask that the clinical team consider RRT initiation if there are:
~I. Criteria for persistent AKI (serum creatinine has not declined by more than 50% from value recorded at time of eligibility) AND
~II. At least one of the following indications for RRT initiation:
~Serum potassium ≥6.0 mmol/L, or
~Serum bicarbonate ≤ 10 mmol/L, or
~Evidence of severe respiratory failure, based on a PaO2/FiO2 <200 and bilateral infiltrates on the chest x-ray, or
~By 72 hours after randomization, creatinine has not declined by more than 50% from that recorded at the time of randomization"
16178633|NCT01557335|Drug|Plavix® and PA32540|one Plavix® 300 mg loading dose in the PM of Day 1 one Plavix® 75 mg maintenance dose in the PM of Days 2-7 PA32540(delayed release aspirin 325 mg plus immediate release omeprazole 40 mg)
16178634|NCT01557335|Drug|EC aspirin (Bayer®) ,EC omeprazole (Prilosec®) , Clopidogrel (Plavix®)|One EC aspirin (Bayer®) 81 mg tablet plus one EC omeprazole (Prilosec®) 40 mg capsule plus one Clopidogrel (Plavix®) tablet of 300 mg (loading dose) all One EC aspirin (Bayer®) 81 mg tablet plus one EC omeprazole (Prilosec®) 40 mg capsule plus one Clopidogrel (Plavix®) tablet of 75 mg (maintenance dose) all taken concomitantly in the AM of Days 2-7
16178635|NCT01557322|Biological|etanercept|This is a Non-interventional study. The data is being analyzed retrospectively. The data consists of 2 cohorts; biologic and non-biologic
16178636|NCT01557322|Drug|methotrexate (MTX)|This is a Non-interventional study. The data is being analyzed retrospectively. The data consists of 2 cohorts; biologic and non-biologic
16178637|NCT01557296|Dietary Supplement|dietary treatment: food of small particle size|Subjects with diabetes mellitus and gastroparesis. Insulin treatment. Dietary treatment with food of small particle size.
16178638|NCT01557296|Radiation|Validate X-ray diagnostic method.|Follow 20 radiopaque markers throw the ventricle by X-ray.
16178639|NCT01557296|Other|Can the motility be improved|Registered the gastric emptying after intervention. Comparing the registrations at the beginning and at the end of the study.
16178640|NCT01557296|Biological|postprandial plasma glucose|Measure the blood glucose response and gastrointestinal symptoms after a test meal
16178641|NCT01557283|Other|Enbrel treatment|Enbrel SC 50mg once weekly or 25mg twice weekly
16178642|NCT01557270|Drug|dexmedetomidine|ropivacaine 100 mg + 150 mcg dexmedetomidine, single shot perineural application
16178643|NCT01557270|Drug|saline|ropivacaine + saline placebo, single shot perineural application
16178644|NCT01557257|Drug|ALO-02|Day 1 (40 mg ALO-02 capsule, single dose) Days 2-5 (40 mg ALO-02 capsule, twice daily)
16178645|NCT01557257|Drug|Naltrexone block|Naltrexone Hcl 50 mg tablet will be administered (1) 12.5 hours prior to, 30 minutes prior to, and 11.5 hours after Day 1 dosing, (2) 30 minutes prior to each dose of study drug on Days 2-5 dosing, (3) 11.5 hours after Day 5 PM dosing
16178646|NCT01557257|Drug|ALO-02|Day 1 (80 mg ALO-02 capsule, single dose) Days 2-5 (80 mg ALO-02 capsule, once daily)
16178647|NCT01557257|Drug|Naltrexone block|Naltrexone Hcl 50 mg tablet will be administered (1) 12.5 hours prior to, 30 minutes prior to, and 11.5 hours after Day 1 dosing, (2) 30 minutes prior to each dose and 11.5 hours after the AM dosing on Days 2-5, (3) 23.5 hours after Day 5 dosing.
16178648|NCT01557257|Drug|OxyContin|Day 1 (40 mg OxyContin tablet, single dose) Days 2-5 (40 mg OxyContin tablet, twice daily)
16178649|NCT01557257|Drug|Naltrexone block|Naltrexone Hcl 50 mg tablet will be administered (1) 12.5 hours prior to, 30 minutes prior to, and 11.5 hours after Day 1 dosing, (2) 30 minutes prior to each dose of study drug on Days 2-5 dosing, (3) 11.5 hours after Day 5 PM dosing
16178650|NCT01557244|Drug|Fesoterodine PR 4 mg|Fesoterodine 4 mg tablet once daily for 24 weeks
16178651|NCT01557244|Drug|Fesoterodine PR 8 mg|Fesoterodine PR 8 mg tablet once daily for 24 weeks, the first week being 4 mg.
16178652|NCT01557244|Drug|Fesoterodine PR 8 mg|Fesoterodine 8 mg tablet once daily for 24 weeks, the first week being 4 mg.
16178653|NCT01557244|Drug|Oxybutynin|Oxybutynin extended release tablets according to approved pediatric labeling for 12 weeks with dose titration phase for first 4 weeks to achieve dose optimisation.
16178654|NCT01557244|Drug|Fesoterodine PR|Fesoterodine 4 mg or 8 mg tablets once daily for 12 weeks after 12 weeks of oxybutinin. Those assigned to 8 mg will take 4 mg for the first week.
16178655|NCT01557244|Drug|Fesoterodine BIC 2 mg|Fesoterodine BIC 2 mg tablet once daily for 24 weeks.
16178656|NCT01557244|Drug|Fesoterodine BIC 4 mg|Fesoterodine BIC 4 mg tablet once daily for 24 weeks, with the first week being 2 mg.
16178657|NCT01557218|Other|Cucumber snack|Three 300-g bowls of vegetables per table: three of cucumber slices
16178658|NCT01557218|Other|Pepper snack|Three 300-g bowls of vegetables per table: three of yellow pepper strips
16178659|NCT01557218|Other|Tomato snack|Three 300-g bowls of vegetables per table: three of grape tomatoes
16178660|NCT01557218|Other|Vegetable variety snack|Three 300-g bowls of vegetables per table: one each of cucumber slices, pepper strips, and grape tomatoes
16178661|NCT01557218|Other|Apple snack|Three 300-g bowls of fruits per table: three of apple wedges
16178662|NCT01557218|Other|Peach snack|Three 300-g bowls of fruits per table: three of peach slices
16178663|NCT01557218|Other|Pineapple snack|Three 300-g bowls of fruits per table: three of pineapple half-rings
16178664|NCT01557218|Other|Fruit variety snack|Three 300-g bowls of fruits per table: of each of apple wedges, peach slices, and pineapple half-rings
16178665|NCT01557192|Device|Low Field Magnetic Stimulation Device|The Low Field Magnetic Stimulation (LFMS) procedure is an application of a series of electromagnetic pulses to the brain lasting twenty minutes. Subjects will be given one 20 minute exposure to either the LFMS or sham electromagnetic field treatment.
16178666|NCT01557179|Device|Hyalofemme|The treatment in both groups was applied every 3 days for a total of 10 applications. Hyaluronic acid vaginal gel was supplied in a 30g aluminum tube with a vaginal applicator which provides a dose of around 5g
16178667|NCT01557179|Device|Estriol cream (Ovestin)|The treatment in both groups was applied every 3 days for a total of 10 applications;Estriol cream was supplied in a 15g vial with a prefilled applicator providing a dose of around 0.5 g
16178668|NCT01557166|Drug|liraglutide|3.0 mg liraglutide administered subcutaneously (s.c., under the skin) once daily for 32 weeks + diet and exercise
16178669|NCT01557166|Drug|placebo|Placebo administered subcutaneously (s.c., under the skin) once daily for 32 weeks + diet and exercise
16178671|NCT01557153|Drug|Placebo|Starting dose will be 5mg/day for four weeks. All participants will be titrated up to the maximum of 10mg/day after 4 weeks. If they do not tolerate this dose, it will be reduced again to 5mg/day and they will continue on their maximum tolerated dose for 12 weeks (for a total of 16 weeks of medication or placebo)
16178672|NCT01557140|Drug|RASi plus carvedilol|Patients were randomly assigned to 2 groups, with 1 group receiving renin-angiotensin system inhibitors (enalapril) plus carvedilol and the other receiving renin-angiotensin system inhibitors (enalapril) plus placebo
16178673|NCT01557127|Drug|Sorafenib (Nexavar, BAY43-9006)|Patients scheduled for treatment with sorafenib given in regular daily dose i.e. 800mg (400mg bid)
16178674|NCT01557114|Drug|Ipilimumab|"Induction: Treatment with ipilimumab will be administered on weeks 1, 4, 7 and 10 at 10mg/kg.
~Maintenance: Ipilimumab will be administered intravenously over 90-minutes at 10 mg/kg every 12 weeks starting at week 24, for as long as the treating physician believes that there is a clinical benefit or for as long as patient is tolerant of therapy"
16178675|NCT01557114|Radiation|Radiotherapy|Radiation therapy 9 Grays in 3 Grays fractions Radiation therapy 15 Grays in 5 Grays fractions Radiation therapy 18 Grays in 6 Grays fractions Radiation therapy 24 Grays in 8 Grays fractions
16178676|NCT01557101|Procedure|COLON CAPSULE ENDOSCOPY ADHERENCE|An exploration with a COLON CAPSULE ENDOSCOPY eaten which capsule has a video-camera in both end to see the colon.
16178677|NCT01557101|Procedure|OPTICAL COLONOSCOPY ADHERENCE|An exploration with an OPTICAL COLONOSCOPY from the anus to see the colon.
16178678|NCT01557088|Other|Blood sampling from the Coronary Sinus and Aorta|Blood samples will be obtained from the aorta and the coronary sinus during the clinically scheduled angiogram and endothelial function testing.
16178679|NCT01557088|Procedure|Intravascular Ultrasound of the coronary artery.|Intravascular Ultrasound will be completed for those subjects testing positive for coronary endothelial dysfunction during a clinically scheduled angiogram and endothelial function testing.
16178680|NCT01557075|Drug|Atorvastatin (High dose statin treatment)|"Patients will be randomly assigned to the type of statins. Randomization of statin therapy will be done 1:1 to one of two different statins on the web-based program
~Atorvastatin 40 mg daily for 12 months after randomization"
16178681|NCT01557075|Drug|Pravastatin (High dose statin treatment)|"Patients will be randomly assigned to the type of statins. Randomization of statin therapy will be done 1:1 to one of two different statins on the web-based program
~Pravastatin 20mg daily for 12 months after randomization"
16178682|NCT01557062|Other|Polysomnography|The Embla® S7000 was used to record full-night at the Sleep Institute (São Paulo, Brazil). The sensors were attached to the patient in a non-invasive manner using tape or rubber bands. The physiological variables were monitored simultaneously and continuously: 4 channels of EEG, 2 of EOG, 4 of EMG and 1 channel of ECG. Airflow detection was made through 2 channels using a pair of thermal sensors and nasal pressure. Respiratory effort of the chest and abdomen, were measured by respiratory inductance plethysmography. Oxygen saturation, were measured with a pulse oximeter. Sleep stages were visually scored in all the PSG according to standardized criteria for the investigation of sleep macrostructure.
16178683|NCT01557062|Other|Teperature measure|Core body temperature was assessed using a thermistor pill (sensor), which is an electronic device 2.23 cm in length and 1.06 cm in diameter that records body temperature and transmits it to a receptor located at the patient's waist called the Core Body Temperature Monitoring System (CorTempTM), that is powered by a silver oxide battery. The components of the sensor are encapsulated in epoxy resin and coated with silicone (HQ Inc., Florida, USA). To ensure that the sensor would be in the intestines and not the stomach, the pill was ingested at least 2 hours (h) before beginning temperature recording. The CBT was recorded every 30 minutes (min) between 10:00pm and 7:00am. The time of pill elimination is variable between individuals and may be as long as 48h.
16178684|NCT01557062|Other|Fibromyalgia Impact questionary|The FIQ is an instrument used to assess the quality of life specifically for patients with FM. This questionnaire consists of 19 questions related to functional capacity, employment status, general well being, psychological disorders and physical symptoms. The higher the score is, the greater is the impact of FM in the individual's quality of life. This questionnaire was validated for Brazilian's population in 2006.
16178685|NCT01557049|Other|Control Group|No physical intervention was given, patients were treated only with medication if necessary.
16178686|NCT01557049|Other|Global Reeducation Group|They were treated with medication if necessary and performed GPR session once a week, during 12 weeks. All the 6 postures from GPR were used during the study.
16178687|NCT01557036|Device|Pipeline Embolization Device|Aneurysms treated independent of study entry with the Pipeline Embolization Device. This is an observational, non-interventional study.
16178688|NCT01557023|Drug|barrier methods|
16178689|NCT01557023|Drug|barrier methods|
16178690|NCT01557010|Drug|DWP05195|Tablets, oral administration, 100mg
16178691|NCT01557010|Drug|DWP05195|Tablets, oral administration, 200mg
16178692|NCT01557010|Drug|DWP05195|Tablets, oral administration, 300mg
16178693|NCT01557010|Drug|Control|Tablets, oral administration, Placebo
16178694|NCT01556997|Drug|XOMA 985|PERa/AMLb capsule taken once daily by mouth for six weeks
16178695|NCT01556997|Drug|Amlodipine Besylate|AMLb capsule taken once daily by mouth for six weeks
16178696|NCT01556997|Drug|Perindopril Erbumine|PERe capsule taken once daily by mouth for six weeks
16178697|NCT01556984|Other|DSA assay|All patients with diabetic foot perform a DSA assay. Before and after DSA, endothelial function will be measured.
16178698|NCT01556971|Drug|Botox|Appropriate patients will randomly receive 29 units of Botox or a saline solution injected in to the procerus and corrugator supercilii frown muscles.
16178699|NCT01556971|Drug|Saline Solution|29 units of saline solution will be injected in to the procerus and corrugator supercilii frown muscles of randomly chosen study participants.
16178700|NCT01556945|Biological|FMP1/AS02|The vaccine antigen FMP1 consists of a recombinant histidine-tagged (His6) fusion protein expressed in E. coli. The lyophilized pellet contained per vaccine vial 62.5 μg merozoite surface protein-142 (MSP-142) with 3.1% lactose as cryoprotectant in each 3 ml monodose vial. The pellet was reconstituted with AS02.
16178701|NCT01556945|Biological|RTS,S/AS02|The vaccine antigen RTS,S, is a recombinant subunit vaccine produced in, and purified from yeast cells. The final lyophilized pellet contained 62.5 μg RTS,S with 3.15% lactose as cryoprotectant per 3 ml monodose vial. The pellet was reconstituted in AS02 and each 0.5 ml dose contained 50 μg RTS,S.
16178703|NCT01556945|Other|Malaria challenge|Experimental challenge homologous strain of P.falciparum sporozoites. Mosquitoes infected with malaria approximately 17 to 19 days earlier and that contained sporozoites in their salivary glands. For each volunteer, five mosquitoes were allowed to feed over five minutes, after which they were dissected to confirm how many were infected, and the salivary glands scored.
16178704|NCT01556932|Drug|ABH gel|Given topically
16178705|NCT01556932|Other|placebo|Given topically
16178706|NCT01556919|Procedure|Standard of care endoscopy|standard of care endoscopy
16178707|NCT01556906|Drug|Lomitapide|Oral administration with escalating doses administered once daily
16178708|NCT01556893|Device|LenSx Laser|The LenSx laser system is a femtosecond laser that has received 510(k) clearance for anterior capsulotomy during cataract surgery (K082947), laser phacofragmentation during cataract surgery (K094052) and for use in the creation of a single and multi-plane arc cut/incisions in the cornea (K092647).
16178709|NCT01556880|Behavioral|Short Message Service (SMS)|A computer-based text message database was created. Messages prompted subjects to get rid of smoking and eating out, to persevere with the quit smoking attempt with the emphasis on the peer pressure on the smoking cessation by the smoking ban in restaurants. They encouraged them to overcome the barriers of healthy eating diet and physical activity with a block of text messages.
16178710|NCT01556867|Other|Cord care by simple debridement (soaping, rinsing and drying)|For children born during an experimental period of cord care will be done with a simple debridement (soaping and then rinsing and drying carefully)
16178711|NCT01556867|Other|Cord care with the use of antiseptics|"For children born during a control period, cord care will be done with an antiseptic whose choice is left to the discretion of the healthcare team.
~In this essay, it opted not to impose an antiseptic. Indeed, the objective of the trial is to compare the two strategies for management of care."
16178712|NCT01556841|Biological|TroVax®|"Pre-amendment 10:
~Patients will be randomised to receive either TroVax® 1 x 10↑9 TCID50/mL in 1mL (experimental arm) or matched placebo (control arm) on a 1:1 basis. A single dose will be given by intramuscular injection during the following weeks: 2, 4, 7, 10, 13, 19, 25, 31, 37, 43 and 49. No further treatment will be given beyond week 49.Treatment will be stopped early if confirmed progression or unacceptable toxicity.
~Post-amendment 10:
~Patients will be registered to receive TroVax 1 x 10↑9 TCID50/mL in 1mL only. A single dose will be given by intramuscular injection during the following weeks: 2, 4, 7, 10, 13, 19 and 25. No further treatment will be given beyond week 25.Treatment will be stopped early if confirmed progression or unacceptable toxicity."
16178713|NCT01556841|Biological|Placebo|"Pre-amendment 10:
~Matched placebo will be administered as above.
~Post-amendment 10:
~TRI-70 onwards received TroVax only."
16178714|NCT01556815|Procedure|Transarterial Chemoembolization (TACE)|Procedure:TACE TACE will be carried out with an emulsion of 50mg doxorubicin with lipiodol in a total volume of 10-20 mL; additional embolisation will be carried out with gelatin sponge particles. TACE will be repeated every 4 weeks for 2 cycles; additional cycles will be offered if clinically indicated .
16178715|NCT01556815|Other|Sorafenib in combination with TACE|"Drug: Sorafenib All patients will receive Sorafenib (800 mg/day) p.o. beginning one week after the first TACE and every day thereafter until patient death or premature withdrawal from study.
~Procedure: TACE
~TACE will be carried out with an emulsion of 50mg doxorubicin with lipiodol in a total volume of 10-20 mL; additional embolisation will be carried out with gelatin sponge particles. TACE will be repeated every 4 weeks for 2 cycles; additional cycles will be offered if clinically indicated ."
16178716|NCT01556802|Drug|Minocicline|Minocicline 100mg oral twice a day for 5 days
16178717|NCT01556802|Drug|Placebo|Pills with vegetable fibers one pill oral twice a day for five days
16178718|NCT01556789|Biological|ONT-10|ONT-10 a liposomal synthetic glycolipopeptide antigen formulated with PET Lipid A adjuvant.
16178719|NCT01556776|Drug|lenalidomide|placebo or lenalidomide 5 mg daily on days 1-28 of the first 28-day cycle. If the 5 mg dose level is well tolerated, escalation to 10 mg daily on days 1-28 of cycle 2-6 is permitted; further escalations starting with the 7th cycle and up to the 12th cycle to 15 mg daily is permitted. If after 12 cycles of treatment subjects still present with MRD levels of ≥ 10-4 in peripheral blood and previous dose levels are well tolerated, starting with the 13th cycle up to progression 20 mg daily is permitted. If after 18 cycles of treatment for subjects still present with MRD.levels of ≥ 10-4 in peripheral blood and previous dose levels are well tolerated, starting with the 19th cycle up to progression 25 mg daily is permitted. 25 mg is the maximal daily dose of lenalidomide
16178720|NCT01556776|Drug|Placebo|placebo or lenalidomide 5 mg daily on days 1-28 of the first 28-day cycle. If the 5 mg dose level is well tolerated, escalation to 10 mg daily on days 1-28 of cycle 2-6 is permitted; further escalations starting with the 7th cycle and up to the 12th cycle to 15 mg daily is permitted. If after 12 cycles of treatment subjects still present with MRD levels of ≥ 10-4 in peripheral blood and previous dose levels are well tolerated, starting with the 13th cycle up to progression 20 mg daily is permitted. If after 18 cycles of treatment for subjects still present with MRD.levels of ≥ 10-4 in peripheral blood and previous dose levels are well tolerated, starting with the 19th cycle up to progression 25 mg daily is permitted. 25 mg is the maximal daily dose of lenalidomide
16178721|NCT01556763|Drug|EVP-6124 (0.3 mg/day)|EVP-6124 was administered as one 0.3 mg capsule per day for 21 days.
16178722|NCT01556763|Drug|EVP-6124 (1.0 mg/day)|EVP-6124 was administered as one 1.0 mg capsule per day for 21 days.
16178723|NCT01556763|Drug|Placebo|Matching placebo was administered as one capsule per day for 21 days.
16178724|NCT01556763|Drug|Antipsychotic therapy|Concomitant therapy with antipsychotic medication (aripiprazole [10 to 30 mg/day], olanzapine [10 to 20 mg/day], paliperidone [3 to 12 mg/day], or risperidone [2 to 16 mg/day]), taken at the same time each day as the EVP-6124 dose. Patients must have been taking concomitant therapy for at least 2 weeks at a stable dose to be eligible for the study.
16178725|NCT01556737|Dietary Supplement|High daidzein supplement|8 weeks exposure to the supplement, daily 100 mg of isoflavones
16178726|NCT01556737|Dietary Supplement|High genistein supplement|8 weeks exposure to the supplement, daily 100 mg of isoflavones
16178765|NCT01556425|Other|Usual Care Control|Participants receiving this intervention will be invited to attend the workplace and outpatient drug abuse counseling.
16178766|NCT01556399|Other|Tissue Sampling|A small sample of the duodenal adenoma will be obtained for molecular testing. The remaining adenoma will be sent for regular histological testing.
16178767|NCT01556373|Other|NA : non interventional study|NA : non interventional study
16178727|NCT01556724|Drug|0.1% or 0.2% ropivacaine nerve blocks|Either 0.1% or 0.2% ropivacaine will be infused at 7 mL/hr through lumbar plexus nerve block catheter based upon randomization, and can then receive a 6 ml bolus of either 0.1% or 0.2% ropivacaine. Additional pain relief will be available by nurse administered boluses of additional local anesthetic (from their randomized infusion) with a maximum dose of an extra 3 ml per bolus and limited to one bolus per hour. This bolus of their randomized local anesthetic will remain available until the nerve catheters are removed. Nerve block infusion rates may be increased to 9 ml/h for patients with increased pain without increased motor blockade as determined by the acute interventional perioperative pain service (AIPPS) or decreased to 5 ml/h for patients with increased motor blockade or weakness from the peripheral nerve block as determined by the AIPPS .All continuous lumbar plexus catheters will be removed on post operative day (POD) 2.
16178728|NCT01556698|Drug|NVN1000|
16178729|NCT01556698|Drug|Vehicle|Placebo
16178730|NCT01556685|Other|clinical and neurological evaluation|The day of the usual IFN beta 1a IM injection
16178731|NCT01556685|Other|Blood Sample|For evaluation of interferon-related Nab
16178732|NCT01556685|Genetic|Blood Sample|genetic evaluation - predisposition to Nab generation
16178733|NCT01556672|Drug|Adalimumab|Adalimumab will be administered sub-cutaneously to all patients entering the study with a loading dose of 80 mg followed by 40 mg at week 1 and 40 mg every other week. Patients who did not have small bowel lesions detected will be in the study and receive adalimumab until week 12. Patients who had small bowel lesions detected will be in the study and receive adalimumab until week 24.
16178734|NCT01556672|Device|Capsule endoscopy|All patients will undergo capsule endoscopy (EndoCapsule EC type 1; Olympus) to treatment initiation (adalimumab) in order to detect the presence of small bowel lesions suggestive of Crohn's disease. Twenty-four (24) weeks after treatment with adalimumab was initiated, patients for whom small bowel lesions were detected will undergo a second capsule endoscopy to evaluate changes in bowel inflammation.
16178735|NCT01556659|Drug|Absence of Acenocoumarol|Dual anti-platelet therapy without the addition of Acenocoumarol.
16178736|NCT01556646|Drug|Tolvaptan|15 to 30mg qd titrated to sodium concentration
16178737|NCT01556633|Drug|Tamiflu (oseltamivir)|Single dose of Tamiflu in volunteers on dialysis
16178738|NCT01556633|Drug|Tamiflu (oseltamivir)|Single dose of Tamiflu in volunteers with creatinine clearance from 10 to 30 mL/min
16178739|NCT01556607|Drug|MDT-637|Inhaled doses of MDT-637 over a 24 hour period at 3 visits
16178740|NCT01556607|Drug|Placebo|
16178741|NCT01556594|Drug|Nasal Glucagon 1 mg|
16178742|NCT01556594|Drug|Nasal Glucagon 2 mg|
16178743|NCT01556594|Drug|SC Glucagon|
16178744|NCT01556594|Drug|Nasal Glucagon 3 mg|
16178745|NCT01556581|Procedure|Usual Care (UC)|Initial management for all patients will include an activity-limiting profile for up to 30 days and a 10-day supply of medications if needed (NSAIDs and muscle relaxers). All patients will then receive advice and education about the favorable natural history of LBP and the advantages of remaining as active as possible. All patients will be recommended to follow-up with their primary care provider using normal procedures if they are not satisfied with their progress.
16178746|NCT01556581|Procedure|Early Physical Therapy (PT)|Patients in the early PT group will receive the same treatment as the usual care group, but will then be referred to physical therapy within 3 days. The physical therapy treatment will be based on the Treatment Based Classification system (an approach that places patients into either an extension-oriented, core strength/stabilization, or a spinal manipulation treatment group based on signs and symptoms).
16178747|NCT01556568|Drug|MEK162|
16178748|NCT01556542|Device|paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation|paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation
16178749|NCT01556542|Device|nitinol stent implantation|nitinol stent implantation
16178750|NCT01556529|Procedure|risk profile information|(1) patient on a regular basis receives individualized reports on his/her quantitative risk for 6 typical diabetes complications over the next 10 years, (2) standard T2DMP care, as outlined by AWMF diabetes guidelines
16178751|NCT01556529|Procedure|standard DMP care|standard disease management of T2DM care
16178752|NCT01556529|Procedure|standard DMP care|standard disease management of T2DM care
16178753|NCT01556503|Device|VivaScope System|VivaScope System, Model#s 1500 and 2500
16178754|NCT01556490|Device|TheraSphere|Yttrium 90 microspheres
16178755|NCT01556477|Drug|Azacitidine|Azacitidine 5-2-2 (75 mg/m2/day subcutaneously for 5 days, followed by a 2-day weekend break, followed by azacitidine 75 mg/m2/ day for 2 days every 28 days, no individual dose exceeding 200 mg) for 6 cycles.
16178756|NCT01556477|Drug|azacitidine + lenalidomide|"Azacitidine 5-2-2 (75 mg/m2/day subcutaneously for 5 days, followed by a 2-day weekend break, followed by azacitidine 75 mg/m2/ day for 2 days every 28 days, no individual dose exceeding 200 mg) for 6 cycles.
~Initial dose of lenalidomide is 10 mg 21/28 days, starting day 1 in each azacitidine cycle and leaving the last week before start of next azacitidine cycle free. The dose should increased to 25 mg day 1 in cycle 4 if no toxicity according to predefined criteria occurs. Total treatment period is 24 weeks."
16178757|NCT01556464|Device|Auto-adjusting CPAP|A CPAP device that auto-adjusts the pressure setting over the course of the night, depending on how the patient is breathing.
16178758|NCT01556451|Biological|Zoster Vaccine Live|Zoster vaccine live
16178759|NCT01556438|Biological|Tabalumab|Administered IV
16178760|NCT01556438|Drug|Bortezomib IV|Administered IV
16178761|NCT01556438|Drug|Bortezomib SC|Administered SC
16178762|NCT01556438|Drug|Dexamethasone|Administered orally
16178763|NCT01556425|Drug|Vivitrol|Participants receiving this intervention will receive the FDA-approved dose, route, and schedule of administration of VIVITROL. The dose of VIVITROL of 380 mg will be delivered intramuscularly every 4 weeks.
16178764|NCT01556425|Behavioral|Employment-based opiate abstinence reinforcement|This intervention will require participants to provide opiate-negative urine samples on Monday, Wednesday and Friday to maintain their maximum pay. If a participant provides an opiate-positive urine sample, or fails to provide a scheduled sample, their base pay will be reset from $8 per hour to $1 per hour. On each day after the reset that the participant provides a urine sample that meets the opiate abstinence criteria and attends the workplace for at least 5 minutes, their base pay will increase by $1 per hour until it reaches the maximum of $8 per hour.
16178771|NCT01556321|Dietary Supplement|placebo|Subjects will receive placebo (soy oil; 757 mg/capsule, 3 capsules with each breakfast, lunch and dinner) in capsule form after their baseline measurement, which they have to consume daily for a period of twelve weeks.
16178772|NCT01556321|Dietary Supplement|green tea (757 mg/capsule [84.5 mg EGCG + 2.1 mg caffeine ]|Subjects will receive green tea (757 mg/capsule [84.5 mg EGCG + 2.1 mg caffeine ], 3 capsules with each breakfast, lunch and dinner)in capsule form after their baseline measurement, which they have to consume daily for a period of twelve weeks.
16178773|NCT01556308|Procedure|Taking of liquid and top of blisters|the liquid and the top of blisters will be took.
16178774|NCT01556282|Device|TheraSphere|TheraSphere are microspheres with y-90 a radioactive material that will be injected into the liver through a blood vessel.
16178775|NCT01556256|Other|Caregiver-Related Intervention or Procedure|Undergo TMV+P
16178776|NCT01556256|Procedure|Music Therapy|Undergo TMV
16178777|NCT01556256|Procedure|Music Therapy|Undergo TMV+P
16178778|NCT01556256|Other|Quality-of-Life Assessment|Ancillary studies
16178779|NCT01556256|Other|Questionnaire Administration|Ancillary studies
16178780|NCT01556243|Procedure|therapeutic conventional surgery|
16178781|NCT01556243|Radiation|whole breast irradiation|
16178782|NCT01556230|Procedure|Surgical intervention for CNFA|(non-experimental) standard procedure
16178783|NCT01556230|Radiation|Radiotherapy for CNFA|(non-experimental) standard procedure
16178784|NCT01556217|Drug|JNJ-39393406|Type= exact number, Unit= mg, Number= 200, Form= oral suspension, Route= oral administration. Oral suspension to be taken once with 240 mL (8 ounces of water) between 8:00 AM and 10:30 AM.
16178785|NCT01556217|Drug|Placebo|Form= oral suspension, Route= oral administration. Oral suspension to be taken once with 240 mL (8 ounces of water) between 8:00 AM and 10:30 AM.
16178786|NCT01556204|Procedure|Robotic surgery|The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect or will be fulgurized using bipolar energy; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis).
16178787|NCT01556204|Procedure|Laparoscopic Surgery|The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect or will be fulgurized using bipolar energy; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis).
16178788|NCT01556191|Drug|Gefitinib|250 mg per day (oral)
16178789|NCT01556191|Drug|Fulvestrant|500 mg (2 x 250 mg), IV by month with an additional 500 mg dose two weeks after the initial dose
16178790|NCT01556191|Drug|Erlotinib|150 mg per day (oral)
16178791|NCT01556165|Drug|rasagiline|1 mg/day, tablets, once daily, orally
16178792|NCT01556165|Drug|placebo|tablets, once daily, orally
16178793|NCT01556152|Drug|GRC 17536 (Medium Dose)|1 BD for 28 days
16178794|NCT01556152|Drug|GRC 17536 (Low Dose)|1 BD for 28 Days
16178795|NCT01556152|Drug|Placebo|Matching Placebo for 28 Days
16178796|NCT01556139|Device|Spirotiger|"The Training group perform 20 sessions of a specific training with Spirotiger, a device allowing respiratory muscle training with isocapnic hyperpnea.
~The setting is the following:
~volume/size of the breathing bag: 50% of the vital capacity (VC) and ventilation (VE= Tidal volume x respiratory rate) at 66% of the MVV aiming to reach 15 minutes of training without breaks. During the initial sessions, the patient can interrupt training every 5 minutes and recover.
~increase in training: after 15 minutes of exercise VE is increased up to 75% of the MVV through modification of the volume of breathing bag or respiratory rate.
~At the end of 15 minutes of exercise, further increases in ventilation are 10% of each previous step."
16178797|NCT01556126|Device|Amphilimus Eluting Stent (CRE8)|Sirolimus formulated coronary eluting stent
16178798|NCT01556113|Other|Omega diet|Eligible subjects will receive omega rich diet for 12 weeks with weekly appointments to obtain food records, draw serum samples and provide meals.
16178799|NCT01556100|Drug|18F-DTBZ AV-133|A total 40 PD subjects will be included in this study. PD subjects between 20 and 80 years of age may be eligible for this study. Candidates are screened with a medical history and physical examination, and blood test.
16178800|NCT01556087|Behavioral|Distress Tolerance|7 individual sessions aimed at increasing distress tolerance skills
16178801|NCT01556087|Behavioral|Health Education|7 individual sessions with didactic health education information
16178802|NCT01556074|Behavioral|Yoga treatment|Biweekly 90-minute group yoga classes for 8 weeks and on non-class days participants will be asked to devote 15 minutes per day to a prescribed home yoga practice.
16178803|NCT01556061|Device|DMAC|The D blade will constitute the experimental treatment and in a cross over fashion will be tested against CMAC blade
16178804|NCT01556061|Device|CMAC|The CMAC Blade will constitute the active comparator treatment and in a cross over fashion will be tested against D-blade
16178805|NCT01556048|Behavioral|Behavioral Activation|Behavioral Activation for Major Depressive Disorder (BA; Martell, Addis, & Jacobson, 2001) is based on behavioral theories of depression, which posit that psychopathology occurs when active, goal-directed behavioral repertoires have been either unreinforced or punished. These aversive consequences tend to reinforce escape and avoidance behavior, such as passively ruminating on unmet needs and/or deprivations, rather than actively engaging the environment. BA employs operant conditioning principles to increase active, goal-directed behavioral strategies and decrease passive or avoidant behavioral strategies to help people engage with and obtain adequate reinforcement from their environment. Use of BA was based research suggesting that disengagement/avoidance is related to prolonged pathology after loss
16178806|NCT01556035|Drug|Lenalidomide|Patient orally treated with lenalidomide 25 mg daily for 21 days with 7 days rest of a 28 days cycle.Treatment maintained for 12 months unless progression
16178807|NCT01556022|Device|ADRCs processed by the Celution System|Subjects will undergo liposuction under anesthesia. Lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs. When randomized to ADRCs, intramyocardial injections of ADRCs will be administered via the MYOSTAR injection catheter.
16178808|NCT01556022|Device|Placebo Comparator: Lactated Ringer's and Subject's Blood|Subjects will undergo liposuction under anesthesia. Lipoaspirate will be processed in the Celution System to isolate and concentrate ADRCs. When randomized to Placebo, intramyocardial injections of Placebo will be administered via the MYOSTAR injection catheter.
16178809|NCT01556009|Drug|Vismodegib|150 mg per day for 7 continuous months then randomized for 3 month intervals to 28 months.
16178810|NCT01556009|Drug|Aminolevulinic acid %20 topical solution|20% topical solution applied every three months from month 10, 13, 16, 19, 22. Applied and incubated for three hours.
16178811|NCT01555996|Behavioral|Early and Intensive Occupational Therapy|"Intervention group:Standard non-pharmacological prevention plus early and intensive OT. Begin in the first 24 hours in CCU admission. OT areas:1)Multi-sensory stimulation:Intense external stimulation, increase alertness,2)Positioning: Fixtures like dorxi-flexion splints, devices for preventing edema,etc,3)Cognitive Stimulation: Awareness, orientation, attention, memory, calculation, praxis and language,4)Training Activities of Daily Living (ADL): Keep a daily routine and independence in hygiene, grooming and feeding,5)Upper Limb Motor Stimulation (ULMS): Activate functional movement and strength ,6)Family involvement.
~General Guidelines for intervention: Visit of an OT twice a day, 40 minutes each time, for 5 days; meeting of family training for promote strategies during the daily visit."
16178812|NCT01555996|Behavioral|Standard non-pharmacological delirium prevention|Non-pharmacological strategies are the first line of approach in the prevention of delirium. It is recommended to implement some of these strategies, which are: Reorientation protocol, including information 4 times a day about time, date, place and reason for hospitalization; early mobilization by physical therapist 3 times a day, corrected sensory impairment (use such as eyeglasses, hearing aids); environment management, use clock and calendar in the patient´s room, promote supervision of a professional or family to avoid physical restraints; sleep protocol, like lower light, noise and nighttime drug administration and finally, reduction of any anticholinergic drugs and minimize the use of benzodiazepines.
16178813|NCT01555983|Drug|Vaporization of Cannabis|Randomized, Controlled Crossover Trial of Vaporized Cannabis using different strengths of THC in patients with Central Neuropathic Pain Active Comparator: Vaporized High Dose 6.7% THC Active Comparator: Vaporized High Dose 2.9% THC Placebo Comparator: Vaporized Placebo THC
16178814|NCT01555970|Drug|N-Acetylcysteine (NAC)|Week 1: 1200 mg (one 600 mg capsule twice a day) Week 2: 2400 mg (two 600 mg capsules twice a day) Weeks 3-16: 3000 mg (two 600 mg capsules in the morning and 3 in the evening)
16178815|NCT01555970|Drug|Placebo|Week 1: one capsule twice a day Week 2: two capsules twice a day Weeks 3-16: two capsules in the morning and 3 in the evening
16178816|NCT01555957|Drug|intravenous lipid|intravenous given daily for 6 weeks
16178817|NCT01555931|Drug|Levonorgestrel-releasing intrauterine system|Placement within 48 hours of delivery
16178818|NCT01555918|Drug|Isavuconazole|oral
16178819|NCT01555918|Drug|Isavuconazole (IV)|intravenous (IV)
16178820|NCT01555905|Device|Threshold PEP or IMT device Phillips-Respironics|The subject will be instructed to take 8-15 deep, forceful breaths through the Threshold device, followed by at least 3 minutes of rest. The process will be repeated 3 more times for a total of 4 sets of 8-15 breaths. IMST will be completed three to five days per week, based upon the subject's daily baseline level of fatigue.
16178821|NCT01555892|Biological|EBV-specific T cells: A|Dose Level 3: 1 x 10^8 cells/m2 + 2 x 10^8 cells/m2
16178822|NCT01555892|Biological|EBV-specific T cells: B|Dose Level 3: 1 x 10^8 cells/m2 + 2 x 10^8 cells/m2
16178823|NCT01555879|Drug|Abatacept|As prescribed by a doctor for patient medical care.
16178824|NCT01555866|Drug|isavuconazole|IV
16178825|NCT01555853|Drug|Abraxane|
16178826|NCT01555840|Device|Magnetically Guided Capsule (MGCE)|"a) MGCE capsule The MGCE capsule is custom-made for observation of the stomach. It is 31 mm in length and 11 mm in diameter and equipped with two image sensors.
~It contains a permanent magnet to enable magnetic guidance in the stomach by magnetic field. b) Guidance system The magnet guidance system is custom-made to guide the MGCE capsule inside the stomach. It has a footprint of 1m× 2m and generates a very low level magnetic fields. c) Conventional gastroscope"
16178827|NCT01555827|Other|Ophthalmological examination & Questionnaire|"The following examinations will be performed, after pupil dilation:
~Examination with SD-OCT (macular scans, macular volume, peri-papillary scan, retinal autofluorescence, infer-red and red-free imaging)
~Colour photographs of the retinal, centered on the macula and on the optic nerve (digital non mydriatic retinal camera)
~Wide-field colour and autofluorescence imaging (Optomap)
~Measure of intra-ocular pressure (pneumotonometer)
~The following informations will be collected through a standardized questionnaire, administered face-to-face during the inclusion visit, or at the moment of the verification of eligibility criteria:
~Age, gender
~educational level
~smoking
~cardiovascular diseases, current medications
~scores at neuropsychological tests"
16178828|NCT01555814|Drug|Amisulpride|4-week open label amisulpride treatment
16178829|NCT01555801|Device|submucosal injection needle ; EUS|The patients will accepted submucosal injection of 5ml saline followed by ordinary endosonography(EUS) before surgery or endoscopic dissection.
16178830|NCT01555801|Device|ordinary endosonography(EUS)|These patients will be accepted ordinary EUS followed by surgery or endoscopic dissection.
16178832|NCT01555775|Dietary Supplement|P-CHO supplement|In the first trial, this group will drink a protein (P)-carbohydrate (CHO) supplement and in the second trial the fruit milk shake.
16178833|NCT01555775|Dietary Supplement|Fruit Milk Shake|The fruit content of the milk shake will be 100 g of strawberry and the amount of banana necessary to guaranty 0.8-1.2 g CHO • kg-1 BW • h-1.
16178834|NCT01555749|Drug|NNC172-2021|One injection administered subcutaneously (s.c., under the skin). Injection of maximum 1.2 mL
16184305|NCT01514201|Drug|Temozolomide|Given PO
16178835|NCT01555749|Drug|placebo|One injection administered subcutaneously (s.c., under the skin)
16178836|NCT01555736|Drug|grass (80%) and rye (20%) pollens allergoids|comparison of two schemes of immunotherapy - preseasonal and perennial immunotherapy.
16178837|NCT01555710|Drug|Carboplatin|AUC 4 mg/mL/min 1 day every 21 days for a max of 6 cycles.
16178838|NCT01555710|Drug|Palifosfamide-tris|130 mg/m2/day 3 days every 21 days for a max of 6 cycles.
16178839|NCT01555710|Drug|Etoposide|100 mg/m2/day 3 days every 21 days for a maximum of 6 cycles.
16178840|NCT01555710|Drug|Carboplatin|AUC 5 mg/mL/min 1 day every 21 days for a max of 6 cycles.
16178841|NCT01555697|Drug|Memantine|Each participant receives a single pill of placebo or active drug (memantine, 10 or 20 mg) and completes about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.
16178842|NCT01555697|Drug|Placebo|Each participant receives a single pill of placebo or active drug (memantine, 10 or 20 mg) and completes about 6 hours of testing in the laboratory. One week later, that participant receives a single pill of the alternate comparator and is again tested in the laboratory. Thus, in total, each participant receives one placebo pill and one active pill, separated by one week.
16178843|NCT01555684|Procedure|percutaneous venoplasty to alleviate chronic cerebrospinal venous insufficiency|percutaneous venoplasty is where a balloon is inserted and inflated into the jugular vein has been developed to improve this drainage of the CNS, reduce venous hypertension and improve symptoms associated with MS
16178844|NCT01555671|Drug|Meperidine|0.5 ml meperidine injection intravenously injected in randomly selected patients
16178845|NCT01555671|Drug|Saline|0.5 ml saline solution injection intravenously injected in randomly selected patients
16178846|NCT01555658|Drug|Bivalirudin|Enrolled patients will be randomized 1:1 in the catheterization laboratory, after the decision to perform PCI by means of planned implantation of stents>33 mm in length in the same coronary vessel, to IV bivalirudin (0.75 mg/kg intravenous bolus followed by 1.75 mg/kg during procedure and 1.25mg/Kg infusion)
16178847|NCT01555658|Drug|Unfractioned Heparin|Enrolled patients will be randomized in the catheterization laboratory, after the decision to perform PCI by means of planned implantation of stents>33 mm in length in the same coronary vessel, to IV UFH (60 IU/kg intravenous bolus followed by boluses with target activated clotting time 200-250 s)
16178848|NCT01555645|Behavioral|Stress management, in two steps|All patients start at the first step of the intervention program with a two hours psychoeducation in stress management. Patients, who don't report a decrease in stress related symptoms, after the first step will be offered an intensive stress management, either in individual or group format. Components included in the intervention concern 1) basic knowledge about cancer, treatment, healthy living and stress reactions, 2) self-awareness with help of diary for thoughts, feelings and behavior 3) instruction in various techniques on how to express negative feelings, how to communicate with others more effectively, how to change behaviors related to stress 4) training these techniques in real-life situations 5) cognitive restructuring 6) spirituality, derived from cognitive behavior therapy.
16178849|NCT01555632|Drug|atorvastatin calcium|Given PO
16178850|NCT01555632|Drug|placebo|Given PO
16178851|NCT01555619|Device|CRT-D System|Implantation of a CRT-D System
16178852|NCT01555606|Other|No intervention|Patients will not be administered any treatment as part of the study and will receive usual care. Patients will be evaluated for PROs by obtaining narratives and photographs.
16178853|NCT01555593|Device|Cardioline Exp'air by Medi-soft - Sorinnes (B)|FeNO measurement in four different moments, the first in the evening, the last three in the morning of the day after. These evaluations will be repeated when the patient enters the unit and after 15 days of rehabilitation activity
16178854|NCT01555580|Drug|Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF)|Participants will receive one dose of GM-CSF (5 µg/kg) by subcutaneous injection for ten (10) consecutive days. The first dose of GM-CSF will be administered by the subject or caregiver under the observation and direction of the study staff during the baseline visit. The subject or caregiver will administer subsequent injections at home.
16178855|NCT01555567|Device|Electrical Stimulation|Electrical stimulation will be delivered 2 times per week
16178856|NCT01555567|Other|Eccentric Exercise|Eccentric Exercise will be delivered 2 times per week
16178857|NCT01555554|Drug|Propranolol Hydrochloride|"Propranolol will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first dose of the study drug (the PDR recommended starting dose of Propranolol XL- Extended Release). Patients will take one 60 mg pill on the morning of surgery.
~On post operative day #1, patients will take one pill of receive propranolol XL 80 mg (once daily by mouth).
~On post operative days #2-#9, patients will take one pill of propranolol XL 120 mg (once daily by mouth).
~On post operative days #10-11, patients will take one pill of propranolol XL 80 mg (once daily by mouth).
~On post operative days #12-13, patients will take one pill of propranolol XL 60 mg (once daily by mouth).
~This will complete the course of propranolol."
16178858|NCT01555554|Other|Placebo|"The placebo pill will be taken for a total of 14 days. On the morning of the surgery, prior to entry into the operating room, patients will receive the first placebo pill to be taken once daily by mouth.
~On post operative days #1-13, patients will take one placebo pill (once daily by mouth).
~This will complete the course of the placebo."
16178859|NCT01555541|Drug|Ofatumumab|1000 mg IV days 0, 7, 14, 21
16178860|NCT01555541|Drug|Etoposide|10 mg/Kg IV over 24 hours daily, days 1-4
16178861|NCT01555541|Drug|Cytarabine|2000 mg/m2 IV twice daily, days 1-4
16178862|NCT01555528|Device|easypod™|Saizen (Somatotropin) as per Summary of Product Characteristics administered by easypod™
16178863|NCT01555515|Procedure|implantation of autologous skin graft after ex-vivo treatment|Subcutan implantation of autologous skin graft after ex-vivo treatment
16178864|NCT01555515|Biological|Subcutan implantation of autologus skin graft after ex-vivo treatment|Subcutan implantation of autologus skin graft after ex-vivo treatment
16178865|NCT01555489|Drug|Ascorbic Acid|3x per week
16178866|NCT01555476|Drug|Ibuprofen|A single 5 mL dose of 200 mg ibuprofen/5 mL experimental suspension, administered orally, with a 48-hour washout between visits
16178867|NCT01555476|Drug|Ibuprofen|A single 5 mL dose of 200 mg ibuprofen/5 mL reference suspension, administered orally, with a 48-hour washout between visits
16178868|NCT01555463|Drug|Azelaic acid foam, 15% (BAY39-6251)|Azelaic acid twice daily topical application
16178869|NCT01555463|Drug|Vehicle foam|twice daily topical application
16178870|NCT01555450|Other|Patient Navigation|Insured people receive firstly a letter to inform them that a patient navigator is available to navigate them during the colorectal screening steps. A free telephone number and the navigator schedule is given. After a minimum of one week the patient navigator begins the telephone outreach.
16178871|NCT01555424|Dietary Supplement|High dose|This arm of the study receives a higher dose of the vitamin D fortified cheese (28,000IU/ 50g of cheddar cheese eaten once a week).
16178872|NCT01555424|Dietary Supplement|Reference dose|This arm of the study receives a lower dose of the vitamin D fortified cheese (200IU/ 50g of cheddar cheese eaten once a week).
16178873|NCT01555398|Dietary Supplement|HIP0901 capsule (Fenofibric acid) Fasting conditions/ Fed conditions|The study drug(HIP0901 capsule(Fenofibric acid, 135mg)) will be administrated under fed or fasting conditions
16178874|NCT01555385|Dietary Supplement|Breakfast juice|single dose (300 ml) in the morning of study day, 3 separate sessions (high-protein vs. high-carbohydrate vs. low-calorie juice), total duration 3 weeks
16178875|NCT01555372|Device|Hook Plate|All participants will have an open reduction internal fixation. The affected upper limb will be temporarily fixed by a sling after admission. Under necessary test, general anaesthetic and antibiotic prophylaxis, the patients will be placed in a beach-chair position in an orthopaedic theatre. The operated side will be prepped and draped and a transverse incision will be made over the fracture site. The fracture ends will be identified, reduced and fixed with HP. X-ray was applied to check the grade of reduction before the operation is completed. Post-operative care will include early active mobilization managed by a standard physiotherapy rehabilitation regime.
16178876|NCT01555372|Device|Locking Plate|All participants will have an open reduction internal fixation. The affected upper limb will be temporarily fixed by a sling after admission. Under necessary test, general anaesthetic and antibiotic prophylaxis, the patients will be placed in a beach-chair position in an orthopaedic theatre. The operated side will be prepped and draped and a transverse incision will be made over the fracture site. The fracture ends will be identified, reduced and fixed with locking plate. X-ray was applied to check the grade of reduction before the operation is completed. Post-operative care will include early active mobilization managed by a standard physiotherapy rehabilitation regime.
16178877|NCT01555333|Drug|arbaclofen|A flexible dose titration will be utilized. Orally disintegrating tablets
16178878|NCT01555320|Drug|Qishen Yiqi Dripping Pills|One packet of Qishen Yiqi Dripping Pills (0.52g) will be given three times a day in addition to regular western medications for the first 6 months, and regular western medications only for the subsequent 6 months.
16178879|NCT01555320|Drug|Qishen Yiqi dripping pills dummy|One packet of Qishen Yiqi Dripping Pills dummy (0.52g) will be given three times a day in addition to regular western medications for the first 6 months, and regular western medications only for the subsequent 6 months.
16178880|NCT01555307|Other|Typical range of motion and muscle strengthening exercises, and balance exercises|Seven typical exercises, and three balance exercises, 10 times each, 3 times a day.
16178881|NCT01555307|Other|Typical group|Seven typical exercises, 10 times each, 3 times a day
16178882|NCT01555281|Drug|Nelfinavir|In phase II, the recommended dose of nelfinavir will be administered orally twice daily (in the morning and in the evening) on d1-d21 every 28 days for a maximum of 4 cycles
16178883|NCT01555281|Drug|Lenalidomide|25 mg of lenalidomide (capsules) will be administered orally daily on d1-d21 every 28 days for a maximum of 4 cycles
16178884|NCT01555281|Drug|Dexamethasone|40 mg (for patients <75 years) or 20 mg (for patients ≥75 years) of dexamethasone (tablets) will be administered orally once per day on d1, 8, 15 and 22 every 28 days for a maximum of 4 cycles
16178885|NCT01555268|Biological|trebananib|Given IV
16178886|NCT01555268|Drug|cytarabine|Given SC
16178887|NCT01555268|Other|laboratory biomarker analysis|Correlative studies
16178888|NCT01555268|Other|pharmacological study|Correlative studies
16178889|NCT01555242|Drug|Aneustat (OMN54)|100 mg active/capsule; oral administration; 28 days/cycle (up to 6 cycles total) 1,000 mg QD 2,000 mg QD 1,500 mg BID 2,000 mg BID 2,500 mg BID
16178890|NCT01555229|Device|Intermittent subglottic secretion drainage|Subglottic secretion drainage is performed using a specially designed endotracheal tube with a separate dorsal lumen that opens immediately above the endotracheal cuff.
16178891|NCT01555229|Device|Continuous subglottic secretion drainage|Subglottic secretion drainage is performed using a specially designed endotracheal tube with a separate dorsal lumen that opens immediately above the endotracheal cuff.
16178892|NCT01555216|Drug|Single injection posterior tibial nerve block|5 ml of 0.5% ropivacaine
16178893|NCT01555216|Drug|Posterior tibial nerve catheter|5ml bolus of 0.5% ropivacaine with 3 ml/h of 0.2% ropivacaine with a bolus every two hours
16178894|NCT01555203|Behavioral|liveWell: A healthy foundation for life|"liveWell is a unique online, mobile-compatible, multi-media, evidence-based program designed to help college students exercise, eat healthy, and manage stress. At the core of the Transtheoretical Model-based intervention is a computer-tailored behavior change intervention (CTI) that analyzes students' responses to reliable and valid assessments of key behavior change constructs using empirically derived pre-programmed decision rules. The rules determine which feedback users receive on how they are doing compared to their peers in their same stage. At follow-up, feedback is further tailored to how students are doing compared to their last session.
~In addition to the CTI, completed three times during the semester, liveWell includes a dynamic portal that is populated with a variety of engaging and interactive stage-matched activities and resources. The portal provides more content and specifics on how to apply each of the processes and principles of change introduced in the CTI."
16178895|NCT01555190|Drug|myo-inositol 1500 gr|
16178896|NCT01555190|Drug|myo-inositol 2000 gr + folic acid 200 mcg|
16178897|NCT01555164|Drug|Ranolazine|Ranolazine tablet(s) administered orally
16178898|NCT01555164|Drug|Placebo to match ranolazine|Placebo to match ranolazine for the duration of the study
16178899|NCT01555164|Drug|Metformin|Metformin tablet(s) administered orally once daily
16178900|NCT01555164|Drug|Placebo to match metformin|Placebo to match metformin for the duration of the study
16178901|NCT01555164|Behavioral|Diet|Participants are instructed to continue the diet regimen prescribed by their physician.
16184306|NCT01514201|Drug|Veliparib|Given PO
16178902|NCT01555164|Behavioral|Exercise|Participants are instructed to continue the exercise regimen prescribed by their physician.
16178903|NCT01555151|Drug|Mometasone furoate|Mometasone furoate (MF) 80 µg once daily delivered via Concept1 device; MF 200 μg once daily delivered via Concept1 device; MF 320μg once daily delivered via Twisthaler® device or 800 μg once daily delivered via Twisthaler® device
16178904|NCT01555151|Device|Concept 1|A single dose dry powder inhaler (SDDPI)
16178905|NCT01555151|Device|Twisthaler|A single dose dry powder inhaler (SDDPI)
16178906|NCT01555138|Drug|Indacaterol|Indacaterol is delivered via a SDDPI.
16178907|NCT01555138|Drug|Salmeterol|Salmeterol/fluticasone is delivered via a MDDPI
16178908|NCT01555125|Drug|secukinumab 150 mg|After the data base lock of week 52 data has been performed, subjects will receive secukinumab 150 mg treatment as open label for the remainder of the extension treatment period
16178909|NCT01555125|Drug|secukinumab 300 mg|After the data base lock of week 52 data has been performed, subjects will receive secukinumab 300 mg treatment as open label for the remainder of the extension treatment period
16178910|NCT01555125|Drug|placebo|Subjects who were on placebo at Week 52 cannot continue in the extension treatment period
16178911|NCT01555112|Drug|Topical AS101|AS101 15% ointment will be applied topically twice daily on external genital warts for up to 16 weeks.
16178912|NCT01555099|Drug|AZD5423|oral inhaled
16178913|NCT01555099|Drug|Budesonide|oral inhaled
16178914|NCT01555099|Drug|Placebo|oral inhaled
16178915|NCT01555086|Procedure|Limited pelvic Lymphadenectomy|approximately 10-14 lymph nodes are removed
16178916|NCT01555086|Procedure|Extended pelvic Lymphadenectomy|approximately 20 lymph nodes are removed
16178917|NCT01555073|Drug|pregabalin/celecoxib|pregabalin/celecoxib; 75mg/400mg day of surgery and (75mg/200mg) twice a day for 13 days.
16178918|NCT01555073|Drug|pregabalin/placebo|pregabalin/placebo; 75mg/placebo day of surgery and (75mg/placebo) twice a day for 13 days.
16178919|NCT01555073|Drug|celecoxib/placebo|celecoxib/placebo; 400mg/placebo day of surgery and 200mg/placebo twice a day for 13 days.
16178920|NCT01555073|Drug|Placebo group|Placebo group, two placebo tablets day of surgery and twice a day for 13 days
16178921|NCT01555060|Dietary Supplement|ferrous gluconate|daily capsule of ferrous gluconate containing 38 mg of elemental iron
16178922|NCT01555047|Procedure|IUI|intrauterine insemination
16178923|NCT01555047|Procedure|IUI|intrauterine insemination
16178924|NCT01555034|Behavioral|movement therapy|exercise, nutrition, movement therapy
16178925|NCT01555034|Other|exercise plus nutrition|exercise, nutrition
16178926|NCT01555021|Genetic|Genotyping assays|"Patients will provide blood samples at the beginning of the study. If the patient is in the AGT group (as opposed to the TAU group), their blood samples will be sent for genotyping immediately. AGT psychiatrists will be given the results of genotyping within 3-5 days in order to decide which antidepressants to use long-term and at what doses. Patients in the Treatment as Usual group will have their blood samples stored for future analysis. Both groups will provide saliva samples for GWAS analysis at a alter date; however, since the study was terminated early, GWAS testing for both groups and genotyping for the TAU group were not performed.
~Patients will receive questionnaires to measure their mood, side effects, and symptoms.
~Patients will be asked to participate in 3 follow-up phone calls (1 month, 3 months, and 6 months) to measure their mood."
16178927|NCT01555008|Drug|LX4211|Subjects will receive LX4211 once daily for 7 days
16178928|NCT01555008|Drug|LX4211 Placebo|Subjects will receive LX4211 placebo once daily for 7 days
16178929|NCT01554995|Drug|LCB01-0371|LCB01-0371 50mg (Cohort 1) 100mg (Cohort 2) 200mg (Cohort 3) 400mg (Cohort 4) 600mg (Cohort 5)
16178930|NCT01554995|Drug|Linezolid|Linezolid 600 mg (Cohort 9) none
16178931|NCT01554982|Drug|ferric citrate|Dose based on monthly serum phosphorus levels with goal of 3.5-5.5 mg/dL for all patients.
16178932|NCT01554969|Drug|capecitabine + ganetespib|"Capecitabine will be started on Day 1 of the concurrent chemo-radiation phase at the specified dose, and is given orally twice daily for the entire duration of radiation therapy.
~Ganetespib will be started on Day 1 of radiation therapy and is administered as IV infusion over 1 hour on days 1, 8, 15 for cycle 1 and then on days 29 and 36 for cycle 2.
~In all patients, ganetespib monotherapy will be given up to 2 weeks prior to start of concurrent chemoradiation. Sequential biopsies will be taken at baseline and prior to the start of concurrent chemoradiation. In the dose escalation part of the study, the starting does of ganetespib is 60mg/m² once weekly, and capecitabine at a dose of 825 mg/m² twice daily."
16178933|NCT01554956|Biological|Human Plasminogen|Eye Drops
16178934|NCT01554943|Other|cardiac MRI|Patients will be submitted to extensive cardiac evaluation several years after completion of adjuvant chemotherapy
16178935|NCT01554930|Drug|Western therapy (mannitol, methylprednisolone, immunoglobulin, febrifuge)|Mannitol:0.5-1.0g/kg，q4h to q8h ivgtt; Methylprednisolone:1mg-2mg/kg·d,qd iv; Immunoglobulin：1g/kg; Others:febrifuge，sedative，etc.
16178936|NCT01554930|Drug|Xiyanping injection plus western therapy|Xiyanping injection:5-10mg/kg/d (0.2-0.4ml/kg/d),qd ivgtt; Mannitol:0.5-1.0g/kg，q4h to q8h ivgtt; Methylprednisolone:1mg-2mg/kg·d,qd iv; Immunoglobulin：1g/kg; Others:febrifuge，sedative，etc.
16178937|NCT01554917|Drug|Iguratimod|taken orally, 2 tablets/day (bid)
16178938|NCT01554904|Device|Facial-Flex|Oral exercise device
16178939|NCT01554878|Procedure|knee surgery|Reparative, replacement or regenerative techniques, with or without associated osteotomy.
16178940|NCT01554865|Dietary Supplement|Optifast|1-2 sachets of Optifast daily as part of diet modification (partial meal replacement diet)
16178941|NCT01554865|Behavioral|Conventional diet counseling|
16178942|NCT01554852|Drug|Induction (intensive pathway) - cyclophosphamide, lenalidomide, & dexamethasone (CRD) regimen|Days 1 & 8 - cyclophosphamide 500 mg PO Days 1-21 - lenalidomide 25 mg daily PO Days 1-4 & 12-15 - dexamethasone 40 mg daily PO This cycle is repeated every 28 days
16178943|NCT01554852|Drug|Induction (intensive pathway) - cyclophosphamide, thalidomide, & dexamethasone (CTD) regimen|Days 1,8,15 (i.e. weekly) - cyclophosphamide 500 mg PO Continuously - thalidomide 50 mg hard capsules. Initially 100 mg daily PO for 3 weeks, increasing to 200 mg daily PO Days 1-4 and 12-15 - dexamethasone 40 mg daily PO The cycle is repeated every 21 days
16178980|NCT01554592|Drug|Withdrawal of statin therapy|Participants currently received statin therapy will have their statin stopped for 12 weeks.
16178944|NCT01554852|Drug|Induction (intensive pathway) - carfilzomib, cyclophosphamide, lenalidomide, & dexamethasone (CCRD) regimen|Days 1 & 8 - cyclophosphamide 500 mg PO Days 1 & 2, 8 & 9, 15 & 16 - carfilzomib 20*/36 mg/m2** IV (*carfilzomib 20 mg/m2 is only administered on days 1 and 2 of cycle 1; **carfilzomib will be dose capped at a body surface area of 2.2 m2) Days 1-21 - lenalidomide 25 mg daily PO Days 1-4, 8, 9 & 15, 16 - dexamethasone 40 mg daily PO This cycle is repeated every 28 days
16178945|NCT01554852|Drug|Induction (non-intensive pathway) - cyclophosphamide, lenalidomide, & dexamethasone attenuated (CRDa) regimen|Days 1 & 8 - cyclophosphamide 500 mg PO Days 1-21 - lenalidomide 25 mg daily PO Days 1-4 & 15-18 - dexamethasone 20 mg daily PO This cycle is repeated every 28 days
16178946|NCT01554852|Drug|Induction (non-intensive pathway) - cyclophosphamide, thalidomide, & dexamethasone attenuated (CTDa) regimen|Days 1, 8, 15, 22 (weekly) - cyclophosphamide 500 mg PO Continuously - thalidomide 50 mg hard capsules; initially 50 mg daily PO for 4 weeks, increasing every 4 weeks by 50 mg increments to 200 mg daily PO Days 1-4 & 15-18 - dexamethasone 20 mg daily PO This cycle is repeated every 28 days
16178947|NCT01554852|Drug|Consolidation (intensive & non-intensive pathways) - bortezomib, cyclophosphamide, & dexamethasone (VCD) regimen|Days 1, 4, 8 & 11 - bortezomib 1.3 mg/m2 SC or IV Days 1, 8, 15 - cyclophosphamide 500 mg PO Days 1-2, 4-5, 8-9 & 11-12 - dexamethasone 20 mg daily PO This cycle is repeated every 21 days
16178948|NCT01554852|Drug|Maintenance (intensive & non-intensive pathways) - lenalidomide maintenance|Days 1-21 - lenalidomide 10 mg daily PO This cycle is repeated every 28 days
16178949|NCT01554852|Drug|Maintenance (intensive & non-intensive pathways - protocol v5.0 only) - lenalidomide plus vorinostat maintenance|Days 1-21 - lenalidomide 10 mg daily PO Days 1-7 & 15-21 - vorinostat 300mg PO This cycle is repeated every 28 days
16178950|NCT01554852|Drug|High dose melphalan therapy and autologous stem cell transplant (intensive pathway only)|High dose melphalan therapy and autologous stem cell transplant to be given as per local practice
16178951|NCT01554839|Behavioral|"Family of Heroes"|One hour online educational tool
16178952|NCT01554839|Behavioral|Baseline and Follow up Surveys|Baseline and follow up questionaires completed online
16178953|NCT01554826|Biological|Influenza Split Vaccine|0.25ml, two doses (540 subjects were randomly assigned to receive the first dose, among them, 515 subjects received a boost dose); two doses were assigned to be vaccinated 4 weeks apart
16178954|NCT01554826|Biological|Inactivated Influenza Vaccine|0.25ml, two doses (270 subjects were randomly assigned to receive the first dose; among them, 263 subjects received a boost dose); two doses was administrated at 4 weeks apart
16178955|NCT01554813|Biological|Influenza split vaccine of 15 μg HA|60 subjects were assigned (20 infants, 20 children and 20 adults) to receive influenza vaccine (split virion), inactivated, 0.5ml, one dose regime
16178956|NCT01554813|Biological|Influenza split vaccine of 15 μg HA|558 subjects were assigned to receive influenza split vaccine, 0.5ml, one dose regime
16178957|NCT01554813|Biological|Influenza split vaccine|280 subjects were assigned to receive influenza split vaccine, 0.5ml, one dose regime
16178958|NCT01554800|Drug|ACP-501|A single dose infusion
16178959|NCT01554787|Drug|Chinese Herb Astragalus membranaceus|Astragalus membranaceus(AM)at a rate of 2.8g three times per day
16178960|NCT01554787|Other|Placebo|at a rate of 2.8g three times per day
16178961|NCT01554761|Procedure|phacoemulsification|After topical anesthesia with Alcaine, 3.0-mm clear corneal incisions were made. Torsional phacoemulsification was performed using the Infiniti Vision System with the OZil handpiece, a 45-degree Kelman miniflared tip, and DuoVisc viscoelastic (all from Alcon).
16178962|NCT01554761|Device|Pentacam (Oculus,Germany)examination|Total corneal astigmatism is obtained by Pentacam at every visit.
16178963|NCT01554748|Procedure|Total joint arthroplasty|
16178964|NCT01554735|Behavioral|Exercise and diet|24 weeks of exercise and diet counselling
16178965|NCT01554722|Procedure|Needle placement|In plane versus out of plane needle placement techniques
16178966|NCT01554709|Device|Aortic Cannulas (CardioGard)|Comparison of aortic cannulas during by pass surgery
16178967|NCT01554696|Drug|peficitinib|oral
16178968|NCT01554696|Drug|Placebo|oral
16178969|NCT01554696|Drug|methotrexate|oral
16178970|NCT01554683|Drug|Low/High/Placebo Dose Keppra (Levetiracetam)|Low Dose (2.5 mg/kg) High Dose (7.5 mg/kg) Placebo (Saline)
16178971|NCT01554670|Procedure|RF micro-tenotomy|an additional bipolar RF-based device (TOPAZ, Arthrocare, Austin, TX) connected to a System2000 generator (Arthrocare, Austin, TX) was used to perform the micro-tenotomy. The device functions using a controlled plasma-mediated RF-based process (Co-ablation).The device was placed on the tendon perpendicular to its surface, for 500 milliseconds, and micro-debridement was performed at 5-mm intervals by a 2-row fashion, which covered most of the foot-print region of the supraspinatous tendon and at a depth of 3 to 5 mm
16178972|NCT01554657|Other|5 Days of Antibiotics|The choice of the specific antibiotic is made by the treating intensive care unit attending physician. The patients will be randomized to two separate groups based on length of antibiotic therapy not specific antibiotics. Therefore, the actual antibiotic that will be given is not determined by the study. The patients all will receive antibiotics for pneumonia chosen by the intensive care unit team, and those in this group receive a goal of 5 days.
16178973|NCT01554657|Other|7 Days of Antibiotics therapy for pneumonia|The choice of the specific antibiotic is made by the treating intensive care unit attending physician. The patients will be randomized to two separate groups based on length of antibiotic therapy not specific antibiotics. Therefore, the actual antibiotic that will be given is not determined by the study. The patients all will receive antibiotics for pneumonia that is determined by the treating intensive care unit team, and those in this group receive a goal of 7 days.
16178974|NCT01554644|Device|Prontosan|Prontosan(TM) Wound Irrigation Solution (PHMB 0.1%, Betaine 0.1%) and Prontosan(TM) Wound Gel (PHMB 0.1%, Betaine 0.1%). Dressings will be changed and the treatment procedure will be repeated daily with 30ml/40 ml wound solution and 30 ml wound gel for a period of 12 weeks.
16178975|NCT01554644|Device|Saline|Saline Wound Irrigation Solution and inert Wound Gel. Dressings will be changed and the treatment procedure will be repeated daily with 30ml/40 ml wound solution and 30 ml wound gel for a period of 12 weeks.
16178976|NCT01554631|Drug|Acarbose (Glucobay ODT, BAYG5421)|
16178977|NCT01554631|Drug|Acarbose (Glucobay, BAYG5421)|
16178978|NCT01554618|Drug|Exenatide Once Weekly|2 mg exenatide once weekly
16178979|NCT01554618|Drug|Placebo|Placebo
16178981|NCT01554592|Drug|Statin therapy|Participants will continue on stable statin therapy.
16178982|NCT01554579|Drug|Gefapixant|BID
16178983|NCT01554579|Drug|Sugar Pill|Placebo
16178984|NCT01554566|Dietary Supplement|honey|The subjects in the I/C group consumed 0.5 ml honey/kg/day in the first 12-week period (period 1) while the subjects in the C/I group did not receive honey as a control in period 1. After period 1 the subjects of each group exchanged their protocol for the following 12-week period (period 2).
16178985|NCT01554553|Procedure|Posterior crural repair|All patients receive gastrectomy, however patients randomized to the experimental arm will also receive posterior crural repair to determine if this will reduce GERD post sleeve gastrectomy.
16178986|NCT01554540|Drug|Cutaneous iontophoresis of treprostinil|Cutaneous iontophoresis of treprostinil 0.1mg/ml, on the forearm and the fingers. (charge 40-240 mC).
16178987|NCT01554527|Procedure|CPAP treatment|6 months of treatment with PAP (CPAP or BPAP)
16178988|NCT01554527|Other|No CPAP treatment|Children randomized to the comparison group will receive routine care
16178989|NCT01554514|Biological|rituximab|rituximab intravenously 100 mg every week for four doses
16178990|NCT01554488|Drug|Inhaled Fluticasone Propionate|Inhaled corticosteroid
16178991|NCT01554462|Dietary Supplement|Eicosapentaenoic acid / Docosahexaenoic acid|650 mg EPA + 650 mg DHA daily
16178992|NCT01554462|Dietary Supplement|Placebo dietary intervention (MUFA) in ADHD group|Placebo contains mono-unsaturated fatty acids (MUFA) in stead of poly-unsaturated fatty acids (PUFA), same energy value
16178993|NCT01554462|Dietary Supplement|Eicosapentaenoic acid / Docosahexaenoic acid|650 mg EPA and 650 mg DHA daily
16178994|NCT01554462|Dietary Supplement|Placebo dietary intervention (MUFA) in healthy control group|Placebo contains MUFA in stead of PUFA, same energy value
16178995|NCT01554449|Procedure|serious game reeducation|It's a daily session (45 minutes) of reeducation by serious game (kinect) compared to a daily session (45 minutes) of conventional reeducation
16178996|NCT01554449|Procedure|functional MRI|the functional MRI (siemens) will be done on 25 stroke patients and 12 healthy volunteers at baseline and at 6 weeks.
16178997|NCT01554436|Behavioral|neuropsychological assessment|"The main criterion of evaluation of the smoking abstinence will be made by the measure of the rate of carbon monoxide (CO) in the expired air between the study start and during the study until 6 months after inclusion.
~The secondary criteria of evaluation are criteria of neuropsychological order, namely the performances in the tests listed: result of NART test,Continuous Performance Test (CPT), Trail Making test, Stroop test, Iowa gambling task. (IGT), Hayling test, N back test, fluence verbal test"
16178998|NCT01554423|Other|Testing and Counseling|Couples will receive information on the transmission and prevention of HIV and STIs, the meaning of test results, and health consequences.
16178999|NCT01554423|Behavioral|Brief Motivational Interview (BMI)|The brief motivational interview (BMI) to be tested in the RCT in Pretoria is a one-session, 45 minute intervention that will coordinate three, 15-minute modules with one module each to (1) reduce hazardous drinking; (2) reduce illicit drug use; and (3) promote condom use.
16179000|NCT01554423|Behavioral|Integrated Family and Cognitive Behavioral Therapy|The IFCBT model is 6 sessions in length and coordinates the delivery of 4 cognitive-behavioral group couples' sessions with 2 individual couples' sessions to prevent HIV and STI co-infections among adult drug users. IFCBT targets HIV risk and protective factors that operate across multiple ecological systems. The four group couples' sessions coordinate Rational Emotive Therapy and Problem Solving Therapy strategies to reduce HIV risk behavior and promote protective behaviors. The two individual couples' sessions utilize structural and strategic approaches to promote adaptive communication and shared responsibility for condom use and gender equality and to directly address and reduce any form of abuse between partners when present.
16179001|NCT01554410|Radiation|Intensity Modulated Radiation Therapy (IMRT)|45 Gy in 25 daily fractions (1.8 Gy per fraction)
16179002|NCT01554410|Drug|Cisplatin|Weekly infusion of 40 mg/m2 x 5 weeks (70 mg maximum)
16179003|NCT01554410|Drug|Gemcitabine|Weekly infusion x 5 weeks at escalating dose levels (50mg/m2, 75mg/m2, 100mg/m2, and 125mg/m2)
16179004|NCT01554397|Radiation|Intensity Modulated Radiation Therapy (IMRT)|45.0 Gy (intact) or 50.4 Gy (postoperative high-risk) in 1.8 Gy daily fractions over 5-5.5 weeks
16179005|NCT01554397|Drug|Cisplatin|Weekly infusion of 40 mg/m2 (80 mg max) x 5 weeks
16179006|NCT01554384|Procedure|Xpert MTB/RIF assay|Automated nucleic-acid amplification test (fully integrated) test for TB
16179007|NCT01554384|Procedure|Smear microscopy|Smear microscopy involve sputum smear with either ziehl-neelsen or auramine-O staining of slides and light or fluorescence microscopy reading
16179008|NCT01554371|Drug|Eribulin|"Given intravenously (IV)
~Phase II: Eribulin mesylate (mg/m2) + Cyclophosphamide (mg/ m2) for advanced breast cancer participants only"
16179009|NCT01554371|Drug|Cyclophosphamide|Given IV
16179010|NCT01554358|Behavioral|Lifestyle intervention|"The women in the intervention group will be given detailed advice about how to achieve the six evidence-based goals of the intervention,7-9 including: 1) reduction in 5-10% of initial body weight in women with body mass index (BMI) ≥24 kg/m2 through the reduction of at least 10% of total calories of their normal meals, 2) total fat intake <30% of energy consumed, 3) carbohydrate intake 55-65% of energy consumed, 4) fiber intake 20-30g per day, and 5) moderate or vigorous exercise for at least 30 min daily, seven days each week.
~--------------------------------------------------------------------------------"
16179011|NCT01554345|Drug|vitamin E +Selenium|vitamin E 400 IU once 8 hrs before operation selenium 150 mic once 8 hrs before operation
16179012|NCT01554332|Device|Motor Cortex Stimulation using SJM EonC Stimulator|Patients will be randomized to receive either active stimulation the first 3 months followed by a one-month washout, followed by Sham Stimulation the next 3 months, vs. the reverse order of treatment, followed by single blind stimulation, and an open label phase.
16179013|NCT01554319|Drug|SB010|"Three ascending dose groups are planned (Groups A, B, C), each consisting of 12 male subjects. Each of the 3 dose groups will be divided into 2 subgroups. First subgroup: 4 subjects (n=3 active compound, n=1 placebo); second subgroup: 8 subjects (n=6 active compound, n=2 placebo).
~Each dose group will be investigated with a new group of 12 subjects (n=9 active compound, n=3 placebo). Dose escalation to next dose level will occur after satisfactory review of safety and tolerability and after review of the pharmacokinetic data (exposure control) of the preceding dose cohorts by the Safety Board.
~Dose group A : 5 mg hgd40/2 mL; Dose group B: 10 mg hgd40/2 mL; Dose group C: 20 mg hgd40/2 mL."
16179014|NCT01554319|Drug|Placebo (phosphate-buffered saline)|"Three ascending dose groups are planned (Groups A, B, C), each consisting of 12 male subjects. Each of the 3 dose groups will be divided into 2 subgroups. First subgroup: 4 subjects (n=3 active compound, n=1 placebo); second subgroup: 8 subjects (n=6 active compound, n=2 placebo).
~Each dose group will be investigated with a new group of 12 subjects (n=9 active compound, n=3 placebo). Dose escalation to next dose level will occur after satisfactory review of safety and tolerability and after review of the pharmacokinetic data (exposure control) of the preceding dose cohorts by the Safety Board."
16179015|NCT01554293|Drug|Matching placebo|Matching Placebo, single dose
16179016|NCT01554293|Drug|PBL 1427 capsules|PBL 1427 capsules 20 mg and 150 mg, single dose
16179017|NCT01554280|Device|Fully coated, removable , self-expanding oesophageal stent|Insertion of the fully coated, removable, self-expanding oesophageal stent for the prevention of oesophageal strictures.
16179018|NCT01554267|Device|Laser-Assisted ICG Dye Angiography (SPY System)|7.5-10mg of ICG dye will be injected at 2 different time points during breast reconstruction with the assistance of the SPY system to determine areas of skin with poor blood flow. These areas are excised during the operation in order to decrease postoperative complications including mastectomy skin flap necrosis and reconstruction failure.
16179019|NCT01554254|Drug|TXA127|300mcg/kg/day, subcutaneous injection for up to 28 days
16179020|NCT01554241|Dietary Supplement|D3 2000 IU/day|2000 IU/day D3
16179021|NCT01554241|Dietary Supplement|D3 4000 IU/day|vitamin D3 4000 IU/day
16179022|NCT01554241|Dietary Supplement|D3 50,000 IU weekly|vitamin D3 50,000 IU/week
16179023|NCT01554241|Dietary Supplement|vitamin D3 800 IU/day|vitamin D3 800 IU/day
16179024|NCT01554228|Other|Observation|Observational study to examine changes in cognition following bariatric surgery after one year.
16179025|NCT01554215|Behavioral|Mom Power Intervention Group|attachment-based parenting program for parents in community setting led by trained and experienced facilitators.
16179026|NCT01554215|Behavioral|Mom Power Attentional Control Group|at home control, weekly mailings
16179027|NCT01554202|Behavioral|assessment of memory|
16179028|NCT01554202|Biological|circulating tPA dosage|
16179029|NCT01554202|Genetic|ApoE4|
16179030|NCT01554202|Other|Brain imaging examination MRI and PET examinations|
16179031|NCT01554189|Drug|MK-8325|MK-8325 capsules, orally, once per day for 5 days, at a dose determined by panel assignment (10-200 mg)
16179032|NCT01554189|Drug|Placebo|Placebo to match MK-8325 capsules, orally, once per day for 5 days
16179033|NCT01554176|Drug|Filorexant|Filorexant, one 10 mg tablet, orally, once daily at bedtime
16179034|NCT01554176|Drug|Placebo|Placebo, one tablet, orally, once daily at bedtime
16179035|NCT01554163|Drug|Etoricoxib 30 mg|Etoricoxib 30 mg tablet once daily for 12 weeks.
16179036|NCT01554163|Drug|Celecoxib 200 mg|Celecoxib 200 mg once daily for 12 weeks
16179037|NCT01554150|Behavioral|Method of Levels Cognitive Therapy|In MOL the therapist has two goals: to get the client to talk about his or her problem as it is currently being experienced, and to ask about disruptions, which are thought to indicate background thoughts coming into awareness. The assumption is that when somebody is experiencing problems that they feel they cannot solve, the only way for these to be properly resolved is for change to come from within that person. The MOL therapist helps the person redirect their awareness to think about the problem in more productive ways. It is present-focused, with the therapist asking questions relating to process rather than content. The therapist does not give advice and there is no homework. In MOL clients schedule sessions as and when they feel they need them and decide how long each session should be.
16179038|NCT01554137|Other|isokinetic strength training|The experimental group will follow a program of 18 sessions (3 sessions per week for 6 weeks) with a physiotherapy treatment (30 minutes) and occupational therapy (30 minutes), and a building session isokinetic concentric mode extensor and flexor muscles of the elbow extensors and wrist flexors.
16179039|NCT01554137|Other|passive motion|The control group will follow a program of 18 sessions of physiotherapy and occupational therapy combined with 18 sessions of passive motion in flexion-elbow extension, wrist flexion-extension on the isokinetic device
16179040|NCT01554124|Drug|Meropenem|"40 mg/kg every 8 hours (every 12 hours in the youngest age group: < 32 weeks GA and < 2 weeks postnatal age).
~Treatment duration = 21 ± 7 days"
16179041|NCT01554111|Drug|Picosulfate sodium,|One sachet of picosalax will be given with at least 4 cups of clear fluids.
16179042|NCT01554111|Drug|phosphosoda rectal enema|The patient will have an enema inserted into the rectum and the liquid contents of the enema will be squeezed into the rectum. The patient will need to hold in the enema for several minutes then can release it.
16179043|NCT01554111|Drug|Pico-Salax and Sodium phosphate enema|Pt will take one sachet of Pico-salax the evening prior to procedure and fleet enema 1 hour before leaving home on the morning of the procedure
16179044|NCT01554098|Procedure|Strategy : Supine first|The initial withdrawal in each of 4 segments of the colon: 1)Caecum, Ascending colon and Hepatic flexure 2) Transverse colon 3) Splenic flexure and descending colon 4) Sigmoid colon, will be performed in two different positions. The intervention in this arm will be withdrawal in the supine position and then with dynamic position change.
16179045|NCT01554098|Procedure|Strategy : dynamic first|The initial withdrawal in each of 4 segments of the colon: 1)Caecum, Ascending colon and Hepatic flexure 2) Transverse colon 3) Splenic flexure and descending colon 4) Sigmoid colon, will be performed in two different positions. The intervention in this arm will be withdrawal with dynamic position change first followed by the supine position.
16179046|NCT01554085|Drug|ALS-002158|ALS-002158
16179047|NCT01554085|Drug|Placebo|placebo
16179048|NCT01554072|Other|Home based pulmonary rehabilitation with exercise|After each group will receive the randomization their booklets containing the exercise routine that should be performed at home., to be held three times a week for two consecutive months. Is also scheduled a visit to the laboratory biweekly Respiratory Functional Assessment in which patients demonstrate their exercise routine program RP semi-home settings for any load, postural corrections and execution of physical exercise, should be refocused.
16179049|NCT01554059|Drug|Bevacizumab|Bevacizumab 5mg/m2 D1,D15,D29,D43;
16179050|NCT01554059|Drug|Oxaliplatin|Oxaliplatin 85mg/m2 D1,D57; Oxaliplatin 85mg/m2 biweekly * 6 doses 3-4 weeks after radical resection
16179134|NCT01553383|Device|"nasal peep valve Provent"|application of nasal peep valve vs dental device and cpap
16179051|NCT01554059|Drug|5-FU|5-FU 2800mg/m2 civ 48 hours D1,D57; 5-FU 2800mg/m2 civ 48 hours biweekly*6 doses 3-4 weeks after radical resection; 5-FU 200mg/m2/day civ D15-19,D22-26,D29-33,D36-40,D43-47;
16179052|NCT01554059|Radiation|Radiotherapy|2GY daily *20次
16179053|NCT01554046|Drug|Methylphenidate- Ritalin IR (Immediate Release)|"Duration of treatment- 4 weeks. Dosage- up to 3 times/day.
~Ages 6-12, up to 25Kg - 35mg maximum per day.
~Ages 6-12, above 25Kg - 50mg maximum per day.
~Ages 12-65, above 25Kg - 80mg maximum per day."
16179054|NCT01554020|Dietary Supplement|Blood Sugar Take Care|One 1200 mg soft gel capsule administered 3X/day for duration of study
16179055|NCT01554020|Dietary Supplement|Placebo|One 1200 mg soft-gel capsule administered 3X/day for duration of study
16179056|NCT01554007|Other|Observation study|No intervention was administered to the participants specifically for the purpose this study. Participant could be on any drug therapy.
16179057|NCT01553981|Drug|Tadalafil|Tab. Tadalafil 20 mg every other day for 6 months
16179058|NCT01553981|Drug|Placebo|Shape , size, color and odor matched Tab. of inert material every other day for 6 months
16179059|NCT01553968|Other|Cycling|30 minutes of cycling at 50% of predetermined maximal performance
16179060|NCT01553955|Procedure|Venipuncture|Blood draw for purposes of training in platelet rich plasma concentration. Trainees will be in pairs and each will draw blood from the other for use in the concentration process.
16179061|NCT01553942|Drug|Afatinib|induction phase-two 4 week cycles. consolidation phase-twenty six 4 week cycles
16179062|NCT01553942|Radiation|Radiation|Daily, Monday-Friday
16179063|NCT01553942|Drug|Cisplatin|Day 1 of each cycle, IV infusion over 60 minutes
16179064|NCT01553942|Drug|Pemetrexed|Day 1 of each cycle, given as IV infusion over 10 minutes after cisplatin infusion
16179065|NCT01553942|Procedure|Surgery|Surgery to remove tumor
16179066|NCT01553929|Other|Physical Training and cognitive activity (EPC group)|The patients of the EPC group will realize 2 weekly sessions of 20 minutes of pédalage. During the exercise, the patients will realize a series of tests of decision-making and perceptive cognitive capacity.
16179067|NCT01553929|Other|Physical training (EP group)|The patients of the group (EP) will realize 2 weekly sessions of 20 minutes of pédalage.
16179068|NCT01553929|Other|control group|no physical training and no cognitive activity
16179069|NCT01553916|Drug|Lithium Carbonate|
16179070|NCT01553916|Radiation|Prophylactic cranial irradiation|
16179071|NCT01553903|Drug|Tamoxifen,|Tamoxifen 20 mg/day during 5 years,
16179072|NCT01553903|Drug|Exemestane|Exemestane 25mg/day during 5 years
16179073|NCT01553903|Drug|Anastrozole|Anastrozole 1 mg/day during 5 years,
16179074|NCT01553903|Drug|Letrozole|Letrozole 2.5 mg/day during 5 years,
16179075|NCT01553890|Other|Blood sample|blood sample, venous blood, about 10 ml will be drawn from participants
16179076|NCT01553877|Dietary Supplement|Pushti packet|A food composed of roasted rice, roasted lentil, molasses and soybean oil
16179077|NCT01553877|Dietary Supplement|Rice based Ready to Use Complementary Food Supplements|A rice based diet.
16179078|NCT01553877|Dietary Supplement|Chick-pea based Ready to Use Complementary Food Supplements|A chick-pea based diet.
16179079|NCT01553851|Drug|GSK1120212|Trametinib (GSK1120212) is a selective MEK1 and MEK2 inhibitor with selective activity towards BRAF and RAS mutant cancer cell lines and hematopoietic cancer cells from AML and CML origins.
16179080|NCT01553838|Device|MRI guided prostate biopsy and TRUS guided biopsy|MRI guided prostate biopsy
16179081|NCT01553786|Drug|Lenalidomide|Lenalidomide
16179082|NCT01553773|Drug|isoflavone|treatments: a gel with 17-β estradiol 0.01% (n = 15) and a gel with isoflavones (genistein 4%). The gels were applied once per day. the lenght of treatment was 24 weeks.
16179083|NCT01553773|Drug|Estradiol|a gel with 17-β estradiol 0.01%. Once per day. The lenght of treatment was 24 weeks.
16179084|NCT01553760|Procedure|Phacoemulsification using an ACM as the sole fluid source|A Tri-MICS system will be used with a sleeveless Kelman 20G tip through a 1.1mm CCI. A specialized 19G anterior chamber maintainer, with thin walls and a large internal diameter of 0.9mm will be inserted through a 1.1mm CCI.
16179085|NCT01553760|Procedure|Conventional Phaco|a conventional Phaco with sleeved Kelman 20G tip, through a 2.4mm CCI
16179086|NCT01553747|Drug|Eluxadoline|Oral tablets twice daily
16179087|NCT01553747|Drug|Placebo|Oral tablets twice daily
16179088|NCT01553721|Drug|udenafil|"Phase IIa - Udenafil Dose 1, Dose 2(Single dose)
~Phase IIb - Udenafil(BID)"
16179089|NCT01553721|Drug|placebo|Phase IIa - placebo Phase IIb - placebo
16179090|NCT01553708|Drug|Epidermal growth factor with silver sulfadiazine cream|Compare the duration for complete partial thickness burn wound healing between sample (epidermal growth factor with silver sulfadiazine cream) and control (silver zinc sulfadiazine cream)
16179091|NCT01553708|Drug|Silver zinc sulfadiazine cream|Compare the duration for complete partial thickness burn wound healing between sample (epidermal growth factor with silver sulfadiazine cream) and control (silver zinc sulfadiazine cream)
16179092|NCT01553695|Other|questionary|Subjects have to fill out a booklet of questionnaires
16179093|NCT01553695|Other|questionary|Subjects have to fill out a booklet of questionnaires
16179094|NCT01553682|Behavioral|Horizons+General Health Promotion (GHP)|Participants will attend the Horizons HIV Prevention Program with an extra workshop on nutrition health promotion. Participants will attend a total of two (2) 5-hour workshops over 2 consecutive Saturdays. They will be led by African American health educators, and have about 8-12 other young women participants. The workshops will discuss gender and ethnic pride, self-esteem, good role models, and how to reduce risky sexual behavior. The nutrition health promotion workshop will give ideas on healthy nutrition and exercise. Participants will be asked to rate the workshop anonymously.
16179095|NCT01553682|Behavioral|Horizons+Motivational Enhancement Therapy (GMET)|Participants will attend the Horizons Plus HIV Prevention Program. Participants will attend a total of two (2) 5-hour workshops over 2 consecutive Saturdays. They will be led by African American health educators, and have about 8-12 other young women participants. The workshops will discuss gender and ethnic pride, self-esteem, good role models, and how to reduce risky sexual behavior. Participants will be asked to rate the workshop anonymously.
16179135|NCT01553370|Other|Increased Dairy Intake|3 additional servings of low fat dairy will be consumed
16179096|NCT01553669|Behavioral|reminiscence therapy|The subjects who are arranged to the experiment group will be intervened using the reminiscence therapy manual proposed by Watt and Cappeliez (2000). According to the manual, the group consisted of six weekly sessions of 90 min each. There will be about four people in each subgroup. During each weekly session, the memories recalled focused on a different theme.
16179097|NCT01553656|Drug|cabozantinib capsules|cabozantinib capsules administered as 25-mg and 100-mg strengths once-daily until disease progression
16179098|NCT01553656|Drug|cabozantinib tablets|cabozantinib tablets administered as 20-mg and 60-mg strengths once-daily until disease progression
16179099|NCT01553643|Drug|Chinese Herb Huang-Chi-Wu-Wu-Tang|Huang-Chi-Wu-Wu-Tang at a rate of 3g two times per day
16179100|NCT01553643|Drug|placebo|at a rate of 3g two times per day
16179101|NCT01553630|Procedure|RIA bone graft|Acute autogenous bone grafting with RIA graft at the time of surgical fixation.
16179102|NCT01553630|Procedure|Surgery without bone graft|Plating of fracture without bone graft
16179103|NCT01553617|Drug|6% hydroxyethyl starch 130/0.4 in an isotonic electrolyte solution (VolulyteTM)|Study drug will be given as part of priming of the ECC and for volume therapy up to the maximum dosage of 50 mL/kg body weight/day
16179104|NCT01553617|Drug|Human serum albumin|Control drug will be given as part of priming of the ECC and for volume therapy up to the maximum dosage of 50 mL/kg body weight/day
16179105|NCT01553604|Procedure|augmentation mammaplasty|Dressing is removed on the first postoperative day
16179106|NCT01553604|Procedure|augmentation mammaplasty|Dressing is removed on the 6th postoperative day
16179107|NCT01553591|Drug|Eluxadoline|Oral tablets twice daily
16179108|NCT01553591|Drug|Placebo|Oral tablets twice daily
16179109|NCT01553578|Other|questionnaire administration|Ancillary studies
16179110|NCT01553578|Procedure|therapeutic touch|Receive healing touch therapy
16179111|NCT01553578|Behavioral|management of therapy complications|Receive healing touch therapy
16179112|NCT01553578|Behavioral|management of therapy complications|Receive guided imagery audiotapes
16179113|NCT01553578|Procedure|standard follow-up care|Receive standard care
16179114|NCT01553565|Procedure|Cold polypectomy|All colorectal polyps up to 10 mm found except for tiny hyperplastic polyps in the rectum and distal sigmoid colon are removed. The technique is cold resection of the polyp without tenting and then suction of the transected polyp into a trap followed by submission to histopathological evaluation.
16179115|NCT01553539|Drug|therapeutic angiotensin-(1-7)|Given SC
16179116|NCT01553539|Other|laboratory biomarker analysis|Correlative study
16179117|NCT01553513|Other|[18F]-FDG positron emission computed tomography|"Patients will receive 20 mg furosemide and 20 mg butylscopolamine together with 370 MBq FDG. 120 minutes after the FDG application a ECG- and respiratory gated cardial PET acquisition will be performed, followed by a CT calcium scan, which will also be used for attenuation correction.
~This will be followed by CT-angiography with the application of 80 ml contrast medium. Patients without betablocker and a heart rate of more than 70 / min will be treated with 50 - 100 mg metoprolol as long as there are no contraindications.
~Subsequently, a 3D-mode whole body PET scan will be acquired followed by a low-dose CT transmission scan from the base of the scull to the iliac crest."
16179118|NCT01553513|Procedure|Invasive coronary angiography|ICA is performed via the femoral artery in three projections (RAO 30°, RAO 15° and LAO 45°) and, if necessary, also in further projections. All angiograms are recorded digitally and assessed quantitatively by two experienced readers, who are blinded to the PET/CT results (Quant-Cor, QCA, Siemens Medical Systems, Forchheim, Germany or Digital Cardiac Imaging Systems, Philips, Eindhoven, Netherlands). The mean stenosis of the vessel is assessed in two projections and the percentage of stenosis is calculated for each single segment. Stenoses are localized by means of the AHA (American Heart Association) classification. Occlusions of the vessels are documented and revascularization is performed immediately in patients with acute coronary syndrome (STEMI, NSTEMI).
16179119|NCT01553513|Procedure|Intravascular ultrasound and virtual histology|"During the procedure an intravascular ultrasound will be recorded in grayscale. Radiofrequency raw-data will be collected at the peak of the R-wave and a VH-IVUS data recorder is used to reconstruct a color-coded map. Acquired data will be evaluated with a dedicated software. The grayscale IVUS images will be analyzed frame by frame and used to measure the diameter of the vessel lumen, of the external elastic membrane (EEM) as well as plaque and media thickness (defined as EEM minus lumen). The plaque burden will be calculated.
~A VH-IVUS analysis will be performed for each frame. Four plaque components will be color-coded: dense calcium white, the necrotic core red, fatty tissue light green and scar tissue dark green. color fractions are expressed as percentage of the plaque area and percentage of plaque volume.
~Lesions will be classified: pathologic intima thickening, fibroatheroma with thin cap, fibroatheroma with thick cap, fibrotic plaque and fibro-calcified plaque."
16179120|NCT01553513|Other|Serum biomarkers|"A 20 ml blood sample will be obtained from each patient. The following biomarkers will be assessed: glucose level, HBA1C, cholesterol levels, LDL cholesterol, HDL cholesterol, triglycerides, fibrinogen, factor XIII, plasminogen, complement C3, TNF-alpha, IL-6, CRP, resistin, adiponectin, CD40, 5-lipoxygenase, MMP-9, MMP-1, osteopontin, osteoprotegerin, fetuin, FGF21.
~ELISA and/or calorimetric assays will be used for the biochemical analyses of the serum markers."
16179121|NCT01553500|Dietary Supplement|glucomannan|glucomannan is administered at dosage of 5g/day in form of biscuits (6 biscuits/day)
16179122|NCT01553500|Behavioral|lifestyle intervention|hypocaloric diet (25-30 Kcal/kg/day) or isocaloric (40-45 Kcal/kg/day) and physical activity
16179123|NCT01553487|Other|Forearm vibration|All cases will be trained by forearm vibration device 5 times a week for six weeks period.
16179124|NCT01553448|Genetic|gene expression analysis|
16179125|NCT01553448|Genetic|protein expression analysis|
16179126|NCT01553448|Other|enzyme-linked immunosorbent assay|
16179127|NCT01553448|Other|immunohistochemistry staining method|
16179128|NCT01553448|Other|laboratory biomarker analysis|
16179129|NCT01553448|Other|medical chart review|
16179130|NCT01553435|Drug|Dextromethorphan|The study medicines shall be administered via tube.
16179131|NCT01553435|Drug|Placebo|The study medicines shall be administered via tube.
16179132|NCT01553422|Other|Fluid therapy (Saline Normal)|Saline Normal 1 Lit. during 30 minutes
16179133|NCT01553422|Other|Fluid therapy (Saline Normal)|saline Normal 1 lit during 30 minutes
16179136|NCT01553370|Other|Supplemental carbohydrate|Maltodextrin will be provided in an amount equal to the the energy content in the 3 supplemental servings of low-fat dairy.
16179137|NCT01553357|Drug|Lenalidomide, dexamethasone|"Enrolled patients received lenalidomide at a dose of 25 mg/d for 21 days and oral dexamethasone at a dose of 40 mg on days 1, 8, 15, and 22 for each 28-day cycle. After 4 cycles, responding patients not eligible for SCT continued until 8 cycles of full-dose LD, if tolerated, followed by a maintenance dose of single agent lenalidomide equal to 10 mg/d on days 1-21 of each 28-day cycle.
~Patients responding after 4 cycles and eligible for SCT proceeded according to single Centre transplant policy. Patients not responding after 4 cycles or progressing during this treatment were considered off-study."
16179138|NCT01553331|Procedure|dissection of gallbladder in laparoscopic cholecystectomy|Laparoscopic cholecystectomy with diathermy hook starting from triangle of Calot
16179139|NCT01553331|Procedure|dissection of gallbladder in laparoscopic cholecystectomy|laparoscopic cholecystectomy with ultrasonic scissors starting from fundus
16179140|NCT01553318|Drug|Ketotifen|After meeting the full eligibility requirement, participants will be randomized. From week 1 to 2, subjects will receive either ketotifen 1 mg by mouth, twice a day or the equivalent placebo. Thereafter, subjects will take ketotifen to 2 mg by mouth twice a day or the equivalent placebo.
16179141|NCT01553318|Drug|Placebo (Sugar Pill)|After meeting the full eligibility requirement, participants will be randomized. From week 1 to 2, subjects will receive either ketotifen 1 mg BID or the equivalent placebo. Thereafter, subjects will take ketotifen to 2 mg BID or the equivalent placebo.
16179142|NCT01553305|Other|Supervised high-intensity exercise programme|Six-weeks supervised high-intensity muscle strength training and physical fitness with training sessions twice a week followed by 6-weeks unsupervised high-intensity exercise programme.
16179143|NCT01553305|Other|Exercise programme|Supervised exercise programme
16179144|NCT01553292|Device|ECALMIST|Labelled catheter at level of the lips (6 cm plus weight) will inserted through the vocal cords under direct vision using a standard laryngoscope without premedication while maintaining CPAP. 5 ml/kg surfactant syringe will be connected to the catheter hub and 0.25-0.5 ml was administered; then the syringe will be disconnected from the catheter to observe the surfactant moving up and down or coming back as indication of accurate intubation of the trachea. The surfactant the slowly administer by boluses of 0.25-0.5 ml over 20-30 seconds with 10 seconds apart. At the end of the procedure, the operator flushed the catheter with 0.5 ml of air before removing the catheter while maintaining CPAP
16179145|NCT01553292|Device|ECALMIST|Vascular catheter of 1.6 French size of 133 mm length 16 gauge used to deliver the BLES; a large volume surfactant while maintain CPAP
16179146|NCT01553279|Biological|V419|Diphtheria and Tetanus toxoids and acellular Pertussis adsorbed, inactivated Poliovirus, Haemophilus b conjugate [meningococcal outer membrane protein complex], and Hepatitis B [recombinant] vaccine administered via 0.5 mL intramuscular injection.
16179147|NCT01553279|Biological|PREVNAR 13®|Pneumococcal conjugate vaccine (13-valent, adsorbed) administered via 0.5 mL intramuscular injection (routine vaccination).
16179148|NCT01553279|Biological|MCC-TT|Meningococcal Group C polysaccharide conjugate vaccine to tetanus toxoid adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age
16179149|NCT01553279|Biological|MCC-CRM|Meningococcal Group C conjugate vaccine to CRM-197 adsorbed 0.5 mL intramuscular injection at 3 and 4 months of age
16179150|NCT01553279|Biological|Hib-MCC|Haemophilus type b and meningococcal Group C conjugate vaccine administered via 0.5 mL intramuscular injection.
16179151|NCT01553279|Biological|MMR Vaccine|Measles, mumps, and rubella vaccine (live) given via 0.5 mL intramuscular injection (routine vaccination).
16179152|NCT01553266|Behavioral|Mobile Diabetes Education Teams intervention|A MDET (one Registered Nurse and Registered Dietician) supports primary care physicians by providing diabetes management education to the PCPs' patients onsite, one to four times a month based on patient volume.
16179153|NCT01553240|Device|TMS and functional MRI (Magstim)|single and paired pulse low frequency TMS. 3T structural MRI scans, amplitude modulated continuous arterial spin labeling( CASL) perfusion imaging sequence optimized for 3T is employed for perfusion MR scans using GE FAIR sequence for parallel imaging.
16179154|NCT01553227|Device|ventilator|Noninvasive ventilation including fixed BiPAP ventilation and auto-trilevel ventilation. Using the same IPAP, treatment include one night with BiPAP ventilation mode 1, one night with BiPAP ventilation mode 2 and one night with auto-trilevel ventilation mode. Each treatment last 8 hours for each night.
16179155|NCT01553214|Drug|Filgrastim|Donors shall receive G-CSF 480 mcg as a single 1.6-ml subcutaneous injection 12 to 24 hours prior to donation.
16179156|NCT01553214|Drug|Dexamethasone|Donors shall ingest dexamethasone 8 mg (two 4-mg tablets) orally 12 hours prior to donation.
16179157|NCT01553201|Drug|Botulinum toxin (BoNT)|OnabotulinumtoxinA 100 Units diluted in 4cc saline, one time intramuscular administration
16179158|NCT01553201|Drug|Placebo|Saline, 4cc, one time intramuscular administration
16179159|NCT01553188|Drug|AMG 386|AMG 386 dose will be calculated using the subjects actual body weight (Kg). Supplied in 240 mg v will be administered as an intravenous (IV) infusion using an intravenous infusion pump given over a 60-minute period.
16179160|NCT01553188|Drug|Abiraterone|A 1,000 mg dose of abiraterone should be taken orally once daily
16179161|NCT01553188|Drug|Prednisone|Prednisone should be taken orally either, at 5mg twice a day for each dose or 10 mg once a day a patients preference.
16179162|NCT01553175|Genetic|DNA analysis|
16179163|NCT01553175|Genetic|gene expression analysis|
16179164|NCT01553175|Genetic|mutation analysis|
16179165|NCT01553175|Genetic|protein expression analysis|
16179166|NCT01553175|Other|immunohistochemistry staining method|
16179167|NCT01553175|Other|laboratory biomarker analysis|
16179168|NCT01553162|Genetic|DNA analysis|
16179169|NCT01553162|Genetic|RNA analysis|
16179170|NCT01553162|Genetic|gene expression analysis|
16179171|NCT01553162|Other|laboratory biomarker analysis|
16179172|NCT01553149|Drug|Lenalidomide|Given PO
16179173|NCT01553149|Other|Pharmacological Study|Correlative studies
16179174|NCT01553136|Drug|Varenicline|0.5 mg once per day for Days 1 to 3, 0.5 mg twice per day for Days 4 to 7, then two 0.5 mg tablets (1 mg) twice per day
16179175|NCT01553123|Drug|Ulipristal Acetate|once daily, oral
16179176|NCT01553123|Drug|Iron|once daily, dried ferrous sulfate
16179177|NCT01553097|Other|Neurocognitive impairment observation|None - observational
16179178|NCT01553084|Drug|Varenicline|Participants will receive 12 weeks of pharmacotherapy during the post-quit period plus an additional 7 day pre-quit run-in. Participants will be asked to take a 0.5 mg pill once a day for the first 3 days and then increase to a 0.5 mg pill twice a day (8 hours apart) for 4 days. On the 8th day, their target quit date, they will increase to their target maintenance dose of a 1 mg pill twice daily. If participants report significant adverse events such as nausea, a dose reduction to two 0.5 mg doses per day will be advised.
16179179|NCT01553084|Drug|Nicotine lozenge|Participants will receive 12 weeks NRT. Participants will be given 2 mg or 4 mg lozenges based on morning smoking latency, and will be given package insert use instructions. Medication use will start on the morning of their assigned quit day. They will be urged to use at least 5 pieces/day, unless this amount produces adverse effects.
16179180|NCT01553084|Drug|Nicotine Patch|Participants will receive 12 weeks NRT. Patch dosing will be 8 weeks of 21 mg, then 2 weeks of 14 mg, then 2 weeks of 7 mg (those smoking 5-10 cigs/day will receive reduced patch dosing). Medication use will start on the morning of their assigned quit day. They will be urged to use 1 patch/day, unless it produces adverse effects.
16179181|NCT01553071|Drug|Fenretinide (4-HPR) plus Intravenous Safingol|"A course for this study is defined as the 5 days of treatment with Fenretinide (4-HPR) plus Safingol followed by 16 days of rest. A course is repeated every 21 days if there is no clinical evidence of disease progression for a maximum of six 5-day infusions.
~Days 1-5 of every cycle: Day 1 Fenretinide (4-HPR) intravenous emulsion: 600 mg/m2 for 24 hours Given concurrently (at the same time) with: Safingol intravenous 210 mg/m2 for 24 hours Day 2 Fenretinide (4-HPR) intravenous emulsion: 1000 mg/m2 for 24 hours Given concurrently (at the same time) with: Safingol intravenous 210 mg/m2 for 24 hours Days 3-5 Fenretinide (4-HPR) intravenous emulsion: 1000 mg/m2 continuously for 3 days Days 8 and 15 : Weekly blood draw to monitor side effects requires a clinic visit for approximately 1 hour Days 6,7,9-14, 16-21 Rest and monitor side effects."
16179182|NCT01553058|Drug|Adalimumab (Humira)|Humira will be given at an initial dose of 80mg followed by 40 mg the second week, subsequent doses will be given at 40mg and follow FDA dosing schedule.
16179183|NCT01553058|Drug|Placebo Injection|Placebo injection will be given according to the same dose and schedule as the active comparator.
16179184|NCT01553058|Other|NB-UVB phototherapy|Phototherapy will be given 3 times per week according to the Fitzpatrick scale for skin types.
16179185|NCT01553032|Drug|Erbitux®|400mg/m2 initial dose, followed by weekly doses of 250mg/m2 Treatment duration: 7-8 weeks
16179186|NCT01553032|Radiation|Fractionated Radiotherapy|30-35 fractions of radiotherapy (6-7 weeks)
16179187|NCT01553019|Radiation|Proton radiation|Proton Radiation Therapy: R(0) negative ... 50.40 cobalt gray equivalent (CGE) at 1.8 CGE per fraction ; R(1) micro-positive ...54.00 CGE at 1.8 CGE per fraction; R(2) gross positive...59.40 CGE at 1.8 CGE per fraction
16179188|NCT01553019|Drug|Gemcitabine|Gemcitabine 300 mg/m2 infused over 30 minutes, weekly during proton therapy.
16179189|NCT01553006|Drug|cefditoren pivoxil|comparison of different dosages of cefditoren pivoxil
16179190|NCT01552993|Drug|paracetamol|Paracetamol mixture 20 mg/kg + pacifier and glucose
16179191|NCT01552993|Drug|sucrose|pacifier and sucrose
16179192|NCT01552980|Drug|S-1 and Oxaliplatin|"Oxaliplatin 85mg/m2 D1 and S-1 40mg/m2 BID D1-D10, repeat every two weeks;
~Efficacy will be evaluated every three cycles."
16179193|NCT01552967|Drug|Capecitabine|"Oxaliplatin 85mg/m2 D1 and capecitabine 1g/m2 BID D1-D10, repeat every two weeks.
~Efficacy will be evaluated every three cycles."
16179194|NCT01552954|Behavioral|Intensive education of low salt diet|For 8 weeks, dietitian will call patients to take the information according to pre-defined questionnaire, to check the daily diet habit and daily food taken, and to guide how to lessen sodium intake for 30 min at each call. The call will be done once a week for 8 weeks.
16179195|NCT01552941|Device|Cyberonics VNS System|Active Implantable Electrical Vagal Nerve Stimulator
16179196|NCT01552928|Drug|Anagrelide 0.5 mg|0.5mg Anagrelide single oral dose
16179197|NCT01552928|Drug|Anagrelide 2.5 mg|2.5mg Anagrelide single oral dose
16179198|NCT01552928|Drug|Moxifloxacin|400 mg Moxifloxacin single oral dose
16179199|NCT01552928|Drug|Placebo|Anagrelide placebo + Moxifloxacin placebo single oral dose
16179200|NCT01552915|Drug|Lisdexamfetamine dimesylate|Daily oral dosing in the AM of optimized dose, ranging from 30- 70 mg. 5 week dose optimization, 3 week dose maintenance
16179201|NCT01552915|Drug|Methylphenidate Hydrochloride|Daily oral dosing in the AM of optimized dose, ranging from 18-72 mg. 5 week dose optimization, 3 week dose maintenance
16179202|NCT01552915|Drug|Placebo|Daily oral dosing in the AM for 8 weeks
16179203|NCT01552902|Drug|Lisdexamfetamine dimesylate|Daily oral dosing in the AM ranging from 30- 70 mg. 4 week forced dose titration, 2 week dose maintenance
16179204|NCT01552902|Drug|Methylphenidate Hydrochloride|Daily oral dosing in the AM ranging from 18-72 mg. 4 week force dose titration, 2 week dose maintenance
16179205|NCT01552902|Drug|Placebo|Daily oral dosing in the AM for 6 weeks
16179206|NCT01552889|Behavioral|Collaborative Care|No direct treatment will be offered. We will make treatment recommendations to the patient, PCP and cardiologist. Referral to mental health specialist is also possible, depending on need. The nurse case manager will monitor treatment progress and patient status for duration of the intervention period.
16179207|NCT01552876|Device|etafilcon A|A daily wear contact lens
16179208|NCT01552876|Device|nelfilcon A|A daily wear contact lens
16179209|NCT01552876|Device|Filcon II 3|a daily disposable
16179210|NCT01552863|Drug|Oxycodone|One capsule of 40 mg PF-00345439 Formulation A, single dose
16179211|NCT01552863|Drug|Oxycodone|One capsule of 40 mg PF-00345439 Formulation E, single dose
16179212|NCT01552863|Drug|Oxycodone|One capsule of 40 mg PF-00345439 Formulation F, single dose
16179213|NCT01552863|Drug|Oxycodone|One capsule of 40 mg PF-00345439 Formulation G, single dose
16179214|NCT01552863|Drug|Oxycodone|One capsule of 5 mg PF-00345439 Formulation TBD, single dose
16179215|NCT01552863|Drug|Oxycodone|One capsule of 40 mg PF-00345439 Formulation H, single dose
16179216|NCT01552850|Drug|Oxycodone|1X40 mg PF-00345439 formulation A capsule with water and under fed condition
16179217|NCT01552850|Drug|Oxycodone|1X40 mg PF-00345439 formulation B capsule with water and under fed condition
16179218|NCT01552850|Drug|Oxycodone|1X40 mg PF-00345439 formulation C capsule with water and under fed condition
16179219|NCT01552850|Drug|Oxycodone|1X40 mg PF-00345439 formulation D capsule with water and under fed condition
16179220|NCT01552850|Drug|Oxycodone|40 mg oxycodone oral solution (5 mg/5 ml) with water and under fed condition
16179221|NCT01552837|Drug|Seroquel|for 4 weeks, 300 - 800 mg per day in 2 doses
16179222|NCT01552824|Procedure|CYSTO|Fetal cystoscopy will be performed by introducing a 2.2mm sheath with 1.0mm fetoscope into fetal bladder under ultrasound guidance. The fetoscope will be advanced and the posterior urethral valves will be coagulated by ND:YAG laser. If urethra atresia was diagnosed, a vesico-amniotic shunting will be placed. Maternal anesthesia will be conducted by epidural anesthesia and fetal anesthesia will be conducted by injecting fentanyl (15 μg/Kg) and pancuronium (2 mg/Kg) under ultrasound guidance of a 22 gauge needle into fetal arm muscle.
16179223|NCT01552824|Procedure|Vesico-amniotic shunt|In this arm, all patients randomly selected for this treatment will undergo vesico-amniotic shunting under ultrasound guidance. Maternal anesthesia will be conducted by epidural anesthesia and fetal anesthesia will be conducted by injecting fentanyl (15 μg/Kg) and pancuronium (2 mg/Kg) under ultrasound guidance of a 22 gauge needle into fetal arm muscle.
16179224|NCT01552798|Drug|Acetylsalicylic acid (Aspirin, BAY1019036)|2 x 500 mg fast release aspirin tablets (1000 mg) and 2 x placebo acetaminophen caplets
16179225|NCT01552798|Drug|Acetaminophen|2 x 500 mg acetaminophen caplets (1000 mg) and 2 x placebo fast release aspirin tablets
16179226|NCT01552798|Drug|Placebo|2 x placebo acetaminophen caplets and 2 x placebo fast release aspirin tablets
16179227|NCT01552785|Device|Peripheral near infrared spectroscopy|Devices: NONIN 7600 EQUANOX with sensor Model 8004CA, INVOS 5100c with SAFB-SM, and FORE-SIGHT with medium sensor
16179228|NCT01552772|Drug|Aripiprazole IM Depot|400 mg intramuscular injection of aripiprazole
16179229|NCT01552759|Procedure|Postprandial responses|Subjects ingest a fixed meal, with blood draws to measure appetite hormone levels taken before and after the meal.
16179230|NCT01552759|Behavioral|Cold pressor test|Subjects then undergo the Socially-Evaluated Cold Pressor Test, with blood draws to measure appetite hormone levels taken before and after the test.
16179231|NCT01552759|Behavioral|Test meal|Subjects are presented with an ad libitum buffet meal.
16179232|NCT01552733|Device|'Inmotion Arm Robot'|To improve limb function in those with limb impairment
16179233|NCT01552733|Other|Standard of care|Rehabilitation Therapy
16179234|NCT01552707|Biological|XCEL-MT-OSTEO-ALPHA|"Isolation and ex-vivo expansion of mesenchymal stem cells (MSC) obtained from each patient's bone marrow under GMP conditions at Xcelia, División de Terapias Avanzadas delBanc de Sang i Teixits. After expansion, MSCs are fixed in allogenic bone tissue and implanted in instrumented spinal fusion."
16179235|NCT01552707|Procedure|Standard treatment|Instrumented spinal fusion together with patient's bone iliac crest
16179236|NCT01552694|Drug|Sitagliptin|Oral, 100 mg/day for 2 months
16179237|NCT01552694|Drug|Placebo|oral, matching placebo daily for 2 months
16179238|NCT01552681|Biological|Baminercept|Subjects randomized to baminercept (2:1) will receive 24 weekly injections of 100 mg administered subcutaneously starting at the Day 0 visit and ending at Week 23.
16179239|NCT01552681|Other|Placebo|Subjects randomized to placebo will receive 24 weekly injections of 100 mg administered subcutaneously starting at the Day 0 visit and ending at Week 23.
16179240|NCT01552668|Drug|Fidaxomicin|Receive 200 mg of fidaxomicin twice daily
16179241|NCT01552668|Drug|Placebo|Receive Placebo twice daily
16179242|NCT01552655|Radiation|Dual-time PET/CT (low-dose)|4 MBq/kg 18F-flour-deoxyglucose administered iv. PET/CT-scans performed 60 min and 180 min after injection.
16179243|NCT01552642|Behavioral|face-to-face meetings and access to a website|The intervention group will have 6 weekly face-to-face meetings and will have access to a website.
16179244|NCT01552629|Drug|QGE031|
16179245|NCT01552629|Drug|Placebo|
16179246|NCT01552629|Drug|Cyclosporine A|
16179247|NCT01552616|Procedure|Thermal-aided muscle activation|Thermal-aided muscle activation therapy will be provided to patients twice daily. Treatment will begin within 24 hours of admission and continue until patients are significantly ambulatory.
16179248|NCT01552603|Device|Artificial Pancreas Control Software|This master controller software is used in conjunction with two subcutaneous continuous glucose monitoring systems and two Omnipod pumps, one for administering aspart insulin (NovoLog) and one for administering glucagon (GlucaGen), to control blood glucose levels. The insulin and glucagon infusion rates are determined by an automated version of the Adaptive Proportional Derivative (APD) insulin and glucagon control algorithm.
16179249|NCT01552590|Drug|Tolvaptan|
16179250|NCT01552590|Drug|Placebo|
16179251|NCT01552564|Procedure|Index of microvascular resistance|
16179252|NCT01552564|Other|Cardiac magnetic resonance|
16179253|NCT01552564|Other|Blood markers|
16179254|NCT01552551|Behavioral|Assessment and education|PA Healthy Steps program
16179255|NCT01552551|Behavioral|Healthy Steps with Falls Case Management|Counseling to ensure that participants receive a physician assessment and home safety check
16179256|NCT01552551|Behavioral|Healthy Steps in Motion|Group exercise program
16179257|NCT01552538|Device|Cyberonics VNS System|Stimulation with an active implantable electrical vagal nerve stimulation device
16179258|NCT01552512|Dietary Supplement|Nutributter Program|Nutributter is a ready-to-use nutritional supplement that provides all vitamins and minerals required for healthy growth of infants 6 to 12 months of age. The paste is packaged in 20 gram sachets. One sachet corresponds to the recommended daily dose for a child.
16179259|NCT01552512|Other|Integrated Package|The integrated package of services are provided through the Haitian Ministry of Health and includes childhood vaccinations, family planning messages, diarrhea prevention and control (e.g. water purification methods, promotion of positive sanitation and hygiene practices such as hand washing), and the promotion of positive child feeding practices (e.g. exclusive breastfeeding for six months; increased frequency of complementary feeding; and dietary diversity).
16179260|NCT01552499|Other|Standard of care|
16179261|NCT01552499|Other|Applications of EpiFix|
16179262|NCT01552486|Other|Chiropractic Spinal Manipulative Therapy|Patients will receive a course high-velocity low-amplitude thrust spinal manipulation 3 times per week for 4 weeks.
16179263|NCT01552486|Other|Usual Care|Patients will be under the care of the their general physician and will be allowed the following medications: gabapentin, pregabalin, nortriptyline, amitriptyline.
16179264|NCT01552473|Behavioral|Brain Training Program 1|The training program includes 12 sessions conducted over 8 weeks. The goal of these treatment sessions is to provide information on brain injury and its recovery process. Activities involved in the sessions include discussion of study material. Participants will be encouraged to apply the information to their daily lives. The program includes additional outside practice of the activities.
16179265|NCT01552473|Behavioral|Brain Training Program 2|The training program includes 12 sessions conducted over 8 weeks. The goal of these treatment sessions is to provide strategies to improve brain injury and its recovery process. Activities involved in the sessions include strategies and discussion of study material. Participants will be encouraged to apply the strategies and information to their daily lives. The program includes additional outside practice of the activities.
16179266|NCT01552447|Other|EpiFix|Dehydrated placental tissue
16179267|NCT01552447|Other|Compression Therapy|Compression bandaging
16179268|NCT01552434|Biological|Bevacizumab|Given IV
16179269|NCT01552434|Biological|Cetuximab|Given IV
16179270|NCT01552434|Other|Laboratory Biomarker Analysis|Optional correlative studies
16179271|NCT01552434|Other|Pharmacological Study|Optional correlative studies
16179272|NCT01552434|Drug|Temsirolimus|Given IV
16179273|NCT01552434|Drug|Valproic Acid|Given PO
16179274|NCT01552421|Procedure|TV NOTES cholecystectomy|Transvaginal NOTES cholecystectomy
16179275|NCT01552408|Drug|0.3 mg ranibizumab|Cohort 1: Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity.
16179276|NCT01552408|Procedure|Targeted Pan Retinal Photocoagulation|Cohort 2: Subjects will receive 4 mandatory intravitreal injections of 0.3 mg ranibizumab every 28 days (+/- 7 days). They will then be seen monthly (+/- 7 days) and will receive intravitreal injections of 0.3 mg ranibizumab on a PRN schedule per retreatment criteria based on the evaluating Investigator's assessment of disease activity. In addition, at V3 (Day 7) they will receive targeted pan retinal photocoagulation (PRP) based on ultra wide 200º field angiography. After the first session of PRP, subject's will have ultra wide 200º field angiography performed every 3 months to indicate areas of peripheral ischemia, which will be selectively treated at V9 (Month 6), V21 (Month 18), and V28 (Month 25), preserving areas of more perfused retina. This will minimize any visual field loss secondary to nonselective pan-retinal photocoagulation.
16179277|NCT01552369|Drug|Valganciclovir|Valganciclovir, 900 mg given orally once daily to all Prophylaxis group subjects for 100 days post transplantation as prophylaxis. Valganciclovir, 900 mg given orally twice daily to Preemptive Therapy group subjects as a PET only after a positive CMV PCR test and stopped after PCR is negative for 2 consecutive weeks.
16179278|NCT01552356|Other|Laboratory Biomarker Analysis|Correlative studies
16179279|NCT01552356|Drug|Pazopanib Hydrochloride|Given PO
16179280|NCT01552356|Other|Pharmacological Study|Correlative studies
16179281|NCT01552343|Drug|Desmopressin|Desmopressin orally disintegrating tablets. Female participants took a 25 μg tablet and male participants took a 75 μg tablet one hour prior to bedtime for one month.
16179282|NCT01552343|Drug|Placebo|Placebo to match the 25 μg tablet of active drug taken by female participants or the 75 μg tablet taken by males. One placebo tablet taken one hour prior to bedtime for one month.
16179283|NCT01552330|Drug|Primaquine and Pyronaridine-artesunate|"Subject will receive primaquine (PQ) then receive pyronaridine-artesunate (PA)after 1 week washout period and receive PQ together with PA for the third regimen after 8 weeks washout period
~Primaquine:
~- Dosage: 2 tablets
~and
~Pyronaridine-Artesunate:
~- Dosage: 3 tablets"
16179284|NCT01552330|Drug|Primaquine and Pyronaridine-Artesunate|"Subject will receive primaquine (PQ) then receive PQ together dihydroartemisinin-piperaquine (DHA-PQP) after 1 week washout period and receive DHA-PQP for the third regimen after 8 weeks washout period.
~Primaquine:
~- Dosage: 2 tablets
~and
~Pyronaridine-Artesunate:
~- Dosage: 3 tablets"
16179285|NCT01552317|Other|OxSalt care bundle|A care bundle consisting of a range of features to help patients to reduce their salt intake such as reminder emails, phone calls and a website.
16179286|NCT01552304|Other|Oxygen therapy|Besides perioperative routine care provided by anesthesiologists and surgeons, patients will receive postoperative oxygen supplementation with nasal prolong at 3 liters/min during the first 3 nights after surgery.
16179287|NCT01552304|Other|Control group|
16179288|NCT01552291|Dietary Supplement|Glutamine|30g oral glutamine / day for 5 days before surgery. Glutamine is an important nonessential amino acid and its intracellular concentration is much higher than that of other amino acids. Glutamine is released in large quantities from skeletal muscle and serves as an important carrier and donor of nitrogen
16179289|NCT01552291|Drug|Placebo|30g oral maltodextrin / day for 5 days before surgery
16179290|NCT01552252|Dietary Supplement|apple juice|unaltered(0% POs-Ca) commercially available apple juice
16179291|NCT01552252|Dietary Supplement|apple juice with 0.5% POs-Ca|Phosphoryl Oligosaccharides of Calcium (POs-Ca) in the form of powder was added at concentrations of 0.5% by weight to a commercially available apple juice
16179292|NCT01552252|Dietary Supplement|apple juice with 1% POs-Ca|Phosphoryl Oligosaccharides of Calcium (POs-Ca) in the form of powder was added at concentrations of 1% by weight to a commercially available apple juice
16179293|NCT01552252|Dietary Supplement|apple juice with 1.5% POs-Ca|Phosphoryl Oligosaccharides of Calcium (POs-Ca) in the form of powder was added at concentrations of 1.5% by weight to a commercially available apple juice
16179294|NCT01552252|Dietary Supplement|apple juice with 2% POs-Ca|Phosphoryl Oligosaccharides of Calcium (POs-Ca) in the form of powder was added at concentrations of 2% by weight to a commercially available apple juice
16179295|NCT01552239|Radiation|IMRT/IGRT, Tumor resection, Brachytherapy|"All:
~Preoperative IMRT with small safety margins (GTV according to MRT plus 1.5cm laterally / 3cm proximodistally) to 50Gy total dose, 2 Gy single dose, 5 fractions per week, daily IGRT with in-room CT (Tomotherapy)
~Tumor resection after 4-6 weeks
~Stratum C: Interstitial Brachytherapy to tumor bed with 15 Gy total dose, 3 Gy single dose b.i.d. in second week after tumor resection"
16179872|NCT01547520|Drug|normal saline|25 ml of normal saline, intramuscular, 5 to 10 minutes before EGD
16179296|NCT01552226|Device|Continuous Preperitoneal Analgesia|Preperitoneal catheter placed at the completion of surgery in the standard fashion.
16179297|NCT01552226|Device|Continuous Epidural Analgesia|Epidural catheter placed prior to the operation in the standard fashion.
16179298|NCT01552213|Other|Minimum intervention control group|A single visit with a dietician or health educator to discuss general health risks, good eating habits, and appropriate weight gain. This will be followed by routine prenatal care per provider.
16179299|NCT01552213|Other|Treatment for glucose intolerance|Diet, exercise glucose monitoring, insulin if necessary
16179300|NCT01552200|Procedure|Group A-Standard Colonoscopy, then NaviAid™ G-Eye procedure|Standard Colonoscopy,NaviAid™ G-Eye procedure
16179301|NCT01552200|Procedure|Group B-NaviAid™ G-Eye procedure, then Standard Colonoscopy|G-Eye procedure, Standard Colonoscopy
16179302|NCT01552187|Drug|Colchicine|Colchicine 0.5 mg BID or colchicine 0.5mg (<70kg) 48 to 72 hours before surgery till 1 months after surgery
16179303|NCT01552187|Drug|Placebo|Placebo 48 to 72 hours before surgery till 1 months after surgery
16179304|NCT01552148|Other|USguided bilateral TAP block|23 patients receiving bilateral US guided transversus abdominis plane block with 20ml of 0.375% levobupivacaine on each side, under general anaesthesia (TIVA), after induction and before surgical start
16179305|NCT01552148|Drug|Morphine Patient Controlled Analgesia|Morphine PCA i.v. (bolus 2mg, lockout 8 min)
16179306|NCT01552148|Drug|Morphine Patient Controlled Analgesia|Morphine PCA i.v. (bolus 2mg, lockout 8min)
16179307|NCT01552122|Drug|Odanacatib|Odanacatib 50 mg compressed tablet will be administered orally, once-a-week, for 24 months
16179308|NCT01552122|Drug|Alendronate|Alendronate 70 mg compressed tablets will be administered orally, once-a-week, for 24 months; and a reduced dose of 35 mg will be administered in the same fashion to a subset of women, Japanese participants only, for the same 24-month duration.
16179309|NCT01552122|Other|Placebo (odanacatib)|One compressed tablet administered orally, once-a-week, for 24 months.
16179310|NCT01552122|Dietary Supplement|Cholecalciferol (Vitamin D3)|Two (2) 2800 IU compressed tablets administered orally, once-a-week, for 24 months.
16179311|NCT01552122|Dietary Supplement|Calcium carbonate|Dietary and supplemental sources, taken as needed, to ensure a total daily calcium intake of approximately 1200 mg.
16179312|NCT01552122|Other|Placebo (alendronate)|One compressed tablet administered orally, once-a-week, for 24 months.
16179313|NCT01552096|Drug|peritonsillar infiltration|1.5 ml around each tonsil, 3 minutes before surgical incision as per group description
16179314|NCT01552083|Other|screening of sleep apnea|2 validated screening questionnaires (Berlin questionnaire, Epworth scale)
16179315|NCT01552070|Behavioral|Recruitment maneuver|Recruitment maneuver will be performed immediately (within 2 minutes) after intubation, consisting of a continuous positive airway pressure of 40 cmH2O over 30 seconds.
16179316|NCT01552070|Other|without recruit maneuver|After oral intubation, each patient will be mechanically ventilated, with a tidal volume of 6mL/kg, a respiratory rate of 20 to 25 breaths/minute, a positive end-expiratory pressure (PEEP) of 5 cmH2O, and an FiO2 of 100%. PEEP titration according to FiO2 and ARDSnet.
16179317|NCT01552057|Drug|Duloxetine 60 mg|Duloxetine 60 mg taken orally once every day for 15 weeks
16179318|NCT01552057|Drug|Placebo|Placebo taken orally once every day for 15 weeks
16179319|NCT01552044|Drug|Spironolactone|25mg tablet once a day for 1 month
16179320|NCT01552044|Drug|Placebo|one tablet once a day for 1 month
16179321|NCT01552018|Drug|Saxagliptin|Saxagliptin 5 mg, 1 tablet per day for 3 months
16179322|NCT01552018|Drug|Placebo|Placebo, 1 tablet per day for 3 months.
16179323|NCT01552005|Drug|Saxagliptin|No Intervention
16179324|NCT01551992|Procedure|Quill suture vs. Interrupted suture|To compare two methods of polypropylene mesh attachment during laparoscopic sacrocolpopexy (LSC): running technique using self-anchoring 1 barbed delayed absorbable suture (Quill™ SRS, Angiotech Pharmaceuticals, Inc. Vancouver, Canada) versus interrupted technique using 0 non-barbed delayed absorbable suture (PDS II™, Ethicon, Somerville, NJ, USA).
16179325|NCT01551979|Device|Repetitive Transcranial Magnetic Stimulation|"intermittent Theta Burst (iTBS) pattern (20 trains of 10 bursts given with 8s intervals) will be applied at 80% of active motor threshold. Each participant will receive 600 pulses per session.
~Sham participants will undergo the same procedures as those in the active rTMS group."
16179326|NCT01551966|Device|Wireless esophageal capsule endoscopy ( PillCam Eso2)|"This is a simple blind (blind for the lecture of the capsule endoscopy record) study to evaluate the diagnostic value of the capsule endoscopy for the detection and the control of esophageal varices, the feasibility, tolerance and safety of the capsule endoscopy compared to the conventional EGD under general sedation in children presenting with portal hypertension.
~During one week, the patients will undergo two exams (capsule endoscopy and EGD under general sedation). The exams will be done by two different physicians.
~For to asses the tolerance, after they completed both exams, the patients will be asked to answer a comfort score questionnaire.
~In order to asses the safety of the capsule endoscopy, the patients will be followed for adverse events during 3 weeks after the completion of the capsule endoscopy."
16179327|NCT01551953|Behavioral|Tai chi|12 week tai chi class
16179328|NCT01551953|Behavioral|Mind-body breathing|12 week breathing class
16179329|NCT01551953|Behavioral|Education|12 week education class
16179330|NCT01551940|Drug|Botox injection|Local ultrasound-guided bilateral injection of botulinum toxin type A in parotid (35 UI/gland) and submandibular (15 UI/gland) glands.
16179331|NCT01551940|Drug|Placebo injection|A local ultrasound-guided bilateral injection of placebo (NaCl 0.9 %) in parotid (0.7 ml/gland) and submandibular (0.3 ml/gland) glands.
16179332|NCT01551914|Device|Ultrasonic Scissors (Ethicon)|Haemostasis using Ultrasonic scissors
16179333|NCT01551914|Device|Bipolar Electrosurgical instruments (Medtronic) (SLS- Clips)|bipolar, monopolar or clip coagulation techniques
16179334|NCT01551901|Device|Spinal fusion|Spinal fusion procedures in skeletally mature patients with symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1 with up to grade 1 spondylolisthesis
16179335|NCT01551888|Drug|Aclidinium/formoterol 400/12μg|Aclidinium/formoterol 400/12μg fixed dose combination (FDC), one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Almirall inhaler
16179873|NCT01547507|Device|AirWay Medix Closed Suction System|AirWay Medix Closed Suction System
16179336|NCT01551888|Drug|Formoterol|Formoterol 12 μg one inhalation twice daily (morning and evening) for 4 days, then one inhalation (morning) on Day 5 via the Foradil® Aerolizer®
16179337|NCT01551862|Procedure|body contouring surgery of back, abdomen and thighs|simultaneous body contouring surgery of back, abdomen and thighs
16179338|NCT01551836|Drug|Paracetamol formulation 1|formulation 1
16179339|NCT01551836|Drug|Paracetamol formulation 2|Formulation 2
16179340|NCT01551823|Biological|Influenza Virus Vaccine(no Preservative )|Influenza Virus Vaccine(no Preservative) 2×0.25ml intramuscular injections
16179341|NCT01551823|Biological|Influenza Virus Vaccine(contains Preservative)|Influenza Virus Vaccine(contains Preservative)2×0.25ml intramuscular injections
16179342|NCT01551810|Biological|Influenza Virus Vaccine|Influenza Virus Vaccine 0.5ml intramuscular injections
16179343|NCT01551810|Biological|Influenza Virus Vaccine(contains Preservative)|Influenza Virus Vaccine(contains Preservative)0.5ml intramuscular injections
16179344|NCT01551797|Drug|Paracetamol 500 mg|Standard Paracetamol formulation
16179345|NCT01551797|Drug|Paracetamol 1000 mg|Paracetamol Sustained Release formulation
16179346|NCT01551797|Drug|Paracetamol 750 mg|Paracetamol Sustained Release formulation
16179347|NCT01551771|Drug|GW824575|Investigational treatment - Swedish Orange Coloured, opaque hard gelatin capsule
16179348|NCT01551771|Drug|GW824575 matched-placebo|Placebo
16179349|NCT01551758|Drug|FF/VI|FF/VI
16179350|NCT01551758|Other|Existing Maintenance Therapy|"Existing Maintenance Therapy:
~Long acting bronchodilator therapy alone
~ICS alone or in combination with a long acting bronchodilator
~Triple maintenance therapy"
16179353|NCT01551732|Behavioral|ACT|10 session manualized cognitive behavioral anger control therapy
16179354|NCT01551732|Behavioral|ACT with RAGE-Control|10 session manualized cognitive behavioral anger control therapy augmented with interactive biofeedback videogame.
16179355|NCT01551719|Behavioral|Implemented procedure|Prescription following in vitro sensitivity test implemented with MIC/Breakpoint ratio and penetration of antibiotic in the site of infection.
16179356|NCT01551706|Dietary Supplement|ENI Patented Whole Grape Extract|ENI Patented Whole Grape Extract
16179357|NCT01551706|Other|Placebo|Placebo
16179358|NCT01551693|Drug|STA-9090|
16179359|NCT01551680|Radiation|Radiation combined with iniparib (BSI-201)|"Dose escalation of iniparib is implemented according to the CRML method. Three patients will be included at the first dose level (2.8 mg/kg). As long as no DLT is observed, escalation will proceed in cohorts of three patients at least included at the next dose levels (4, 5.6, 8, 11.2 mg/kg). Once a DLT is observed, the CRML will be activated and will be used until the MTD has been found or until six patients have been treated at the highest dose level (11.2 mg/kg). A dose level of 2.0 mg/kg (dose level -1) is included in case the first dose level at 2.8 mg/kg is found to be the MTD.
~Iniparib is given by iv infusion over 1 hour twice weekly. BSI 201 will start the week before the beginning of radiotherapy (W1) and will be continued during the entire irradiation (W2, W3, W4). It will be stopped after 8 injections.
~RT is delivered five days a week over 3 weeks (W2, W3, W4) up to a total dose of 37.5 Gy. Each fraction delivers 2.5 Gy by two opposed tangential fields."
16179360|NCT01551667|Biological|Antibody assays for S. aureus|Antibody assays for S. aureus at Day 0, Day 2, Day 4, Day 7, Day 30 and Month 6.
16179361|NCT01551667|Biological|Basic blood work|Hemogramme + CRP on Days 0, 2, 4 and 7
16179362|NCT01551654|Device|Transcutaneous Electrical Nerve Stimulation (ITO Company )|A mobile small machine for nerve stimulation
16179363|NCT01551641|Other|chemoradiotherapy|Patients only receive concurrent chemoradiotherapy if their serum VEGF level decrease.
16179364|NCT01551641|Drug|thalidomide|Patients will be given thalidomide combined with concurrent chemoradiotherapy if their serum VEGF level increase or unchanged.
16179365|NCT01551641|Other|without thalidomide|Patients only receive concurrent chemoradiotherapy if their serum VEGF level increase or unchanged
16179366|NCT01551628|Drug|Recombinant human arginase 1 Peg5000|Patients will receive weekly IV infusions of PEG-BCT-100, until evidence of disease progression, intolerable adverse events, or withdrawal of patient consent. For safety sake, each subject will receive an induction dose of PEG-BCT-100 500 U/kg and 1000 U/kg at week -2 and week -1, respectively. The study dose of PEG-BCT-100 1600 U/kg will be initiated at week 1 (Day1). Each escalation of dose level will be determined by the investigator according to each subject's tolerability and criteria for treatment discontinuation.
16179367|NCT01551615|Drug|Metformin 1000 mg|2 x 500 mg oral tablets
16179368|NCT01551615|Drug|Vandetanib 800 mg|2 x 300 mg and 2 x 100 mg oral tablets
16179369|NCT01551602|Drug|AK159|transdermal administration of teriparatide acetate
16179370|NCT01551602|Drug|MN-10-T|subcutaneous administration of teriparatide acetate
16179371|NCT01551602|Drug|Placebo|Multiple administration of placebo AK159
16179372|NCT01551589|Radiation|Involved Field Irradiation(IFI)|Involved Field Irradiation(IFI):only irradiate positive lymph node by CT or PET-CT Radiation: IMRT IMRT is administered with chemotherapy from week 1 to week 8PTV-GTV（primary tumor）：66-70Gy/33~35F，once a day, 5 times per week PTV-CTV（Clinical target,primary tumor extended 3cm in Axial）：50-56Gy/33~35f，once a day, 5 times per week PTV-GTVnd（positive node）：66-70Gy/33~35F，once a day, 5 times per week.
16179373|NCT01551589|Drug|docetaxel and cisplatin|Drug: docetaxel and cisplatin.Consists of docetaxel 60-80mg/m2 day 1 and cisplatin 25mg/m2 days 1 to 3, repeat every 3 weeks, for 2 cycles.
16179374|NCT01551589|Radiation|Elective Nodal Irradiation (ENI)|The CTVn of ENI included the involved lymph node regions and clinically uninvolved lymph nodal stations according to the location of primary tumor. Lymph node station numbers 1/2/4/5/7, 2/4/5/7 and 4/5/7/16/17were included for upper, middle and lower thoracic ESCC in the ENI arm respectively.
16179510|NCT01550406|Device|Tachocomb|"A kind of Mesh:
~ready-to-use hemostatic agent consisting of a collagen sheet coated on one side with human fibrinogen, bovine thrombin, and bovine aprotinin"
16179375|NCT01551550|Procedure|GDD|The surgery includes conjunctival incision, placement and securing the GDD plate in one quadrant, paracentesis and tube insertion into the anterior chamber, tube fixation to the episclera.
16179376|NCT01551550|Procedure|Amniotic Membrane Graft|For subjects assigned to the treatment group, Amnioguard is used to cover the shunt tube. The conjunctiva is then closed.
16179377|NCT01551550|Procedure|Pericardial Graft|For subjects assigned to the control group Tutoplast is used to cover the tube. The conjunctiva is then closed.
16179378|NCT01551537|Other|Cervarix data collection|Safety monitoring: recording of all AEs during the study period using diary cards, follow-up visit or telephone contact.
16179379|NCT01551537|Other|Data Collection|All adverse events will be recorded by diary card, follow-up visit or telephone contact.
16179380|NCT01551524|Biological|mPEG-r-crisantaspase|IV infusion over 60 minutes of mPEG-r-crisantaspase given once every two or four weeks for two administrations. Based on non-clinical data, 500IU/m2 has been selected as the starting dose. Dose selection will proceed based upon safety and pharmacokinetic data but escalation will not exceed 100%
16179381|NCT01551511|Drug|Tetrahydrocannabinol|The add-on treatment consists of two phases: a step-up phase (day 1-5: 3 mg TID; day 6-10: 5 mg TID), and a stable dose phase (day 11-52: 8 mg TID). The dosage may be tapered to at least 5 mg TID, when 8 mg is not tolerated.
16179382|NCT01551511|Drug|Placebo|Identical step-up approach to the Namisol arm.
16179383|NCT01551498|Dietary Supplement|Anatabloc Supplement|Product, as mint-flavored lozenges (3 mg anatabine per lozenge), to be taken 3 times each day
16179384|NCT01551498|Dietary Supplement|Placebo|Placebo, as mint flavored lozenges, to be taken 3 times each day
16179385|NCT01551485|Drug|Zolpidem|The effect of Zolpidem 10 mg for the first night after surgery is asssessed using PSG
16179386|NCT01551485|Drug|Placebo|Pacebo tablet, blinded given on the first night after surgery
16179387|NCT01551472|Device|3DKnee™ System with Vitamin E UHMWPE Tibial Inserts|This device is part of a total knee replacement system utilized in treating patients who are candidates for primary cemented total knee arthroplasty or revision arthroplasty where bone loss is minimal and the collateral ligaments are intact. It is intended to aid the surgeon in relieving the patient of knee pain and restoring knee joint function.
16179388|NCT01551459|Drug|Dacarbazine|Dacarbazine: Patients will receive 1000mg/m2 every 21 days by IV until progression or unacceptable toxicity.
16179389|NCT01551459|Drug|Sunitinib|Sunitinib: Patients will take 50mg orally once a day, for 28 days followed by a 14 day break, until progression or unacceptable toxicity
16179390|NCT01551446|Drug|Bardoxolone Methyl|Oral, once daily
16179391|NCT01551433|Device|wireless pulse oximeter (Wipox)|In addition to the one Wipox measurement at the planned anastomotic site, the RSA will collect the systemic pulse oximeter reading, blood pressure, and heart rate at the time of the Wipox measurement. These measurements will be obtained as both internal controls of the accuracy of the Wipox (matching the Wipox pulse rate with the patient's), as well as additional variables to control for when assessing factors which might contribute to oxygen saturation at the anastomotic site. Pre-operative demographic information will be collected. This will include age, sex, any co-morbidities (cardiac, diabetes, respiratory), and use of pre-operative chemotherapy or chemo-radiotherapy.
16179392|NCT01551420|Device|Advanced upper limb prosthetic device IMU controlled|Advanced upper limb prosthetic IMU controlled
16179393|NCT01551420|Device|Advanced upper limb prosthetic EMG-PR controlled|Advanced upper limb prosthetic EMG-PR controlled
16179394|NCT01551407|Drug|Hexvix|50 ml Hexvix liquid instilled once into the bladder for 30 minutes prior to cystoscopy
16179395|NCT01551394|Drug|Meropenem|20 mg/kg every 8 hours (every 12 hours in the youngest age group: < 32 weeks GA and < 2 weeks postnatal age). The dose will be given as an infusion over 30 minutes. Treatment duration is 11 ± 3 days.
16179396|NCT01551394|Drug|Ampicillin + gentamicin or cefotaxime + gentamicin|"Ampicillin:
~Neonates below 7 days: 50mg/kg every 12 hours Neonates 7-21 days: 50mg/kg every 8 hours Neonates and Infants from day 22 on: 50mg/kg every 6 hours
~Gentamicin:
~Neonates less than 32 weeks of corrected age: 5mg/kg every 36 hours Neonates 32 weeks and over of corrected age: 5mg/kg every 24 hours (pre-dose ('trough') concentrations should be less than 2mg/l) Infants over 28 days of postnatal age: once daily dose: initially 5-7mg/kg, then adjust according to serum-gentamicin concentration (pre-dose ('trough') concentrations should be less than 1mg/l)
~Cefotaxime:
~Neonates below 7 days of PNA: 50mg/kg every 12 hours Neonates and infants from day 7 of PNA: 50mg/kg every 8 hours Treatment duration is 11 ± 3 days."
16179397|NCT01551381|Drug|EV-077|twice daily oral administration
16179398|NCT01551381|Drug|Placebo|twice daily oral administration
16179399|NCT01551368|Drug|Nimodipine|Nimodipine 30 mg tablets will be self-administered by the subjects every 6 hours starting on the day that the ultrasound criterion for hCG triggering is met. The tablets will be taken for two days or until an LH surge is detected, whichever comes first. If no LH surge by 2 days, the hCG trigger (250 micrograms recombinant hCG) will be given followed by intrauterine insemination (IUI)in 40 hours. If the LH surge is detected, hcg will be given immediately and two IUIs will be performed 24 hours apart.
16179400|NCT01551368|Drug|Placebo|Identical inactive tablets.
16179401|NCT01551355|Behavioral|Children-Multicomponent intervention|"The intervened children were provided classroom educational and playful activities during 5 months, which included Sesame Workshop Healthy Habits storybooks, posters, videos, games, and songs (1 hour daily); a Healthy family day workshop (1 hour); and weekly health notes. Parents participated in 3 workshops and weekly notes containing positive health messages about nutrition and active lifestyles to share with their children. Teachers also participated in 3 centralized training sessions, plus personalized working sessions with a research supervisor (2 hours every 15 days), and received a teacher's guide."
16179402|NCT01551329|Drug|Ketalar (ketamine)|Intravenous Ketamine 0.5mg/kg
16179403|NCT01551316|Drug|MN-221|This drug is intravenously infused and delivers 1200 mcg to the patient in 1 hour duration. This dose is repeated over 4 days (Day 1 1200 mcg once; Day 2 1200 mcg twice; Day 3 1200 mcg twice; Day 4 1200 mcg once).
16179404|NCT01551316|Drug|Placebo|This intervention consists of a placebo intravenous infusion, one that contains no active medication. During the double-blind procedure, patients will be infused with placebo intravenously one time on Day 1, twice on Days 2 and 3, and one time on Day 4.
16179405|NCT01551303|Drug|Oxytocin|Liquid metered-dose nasal spray, 30 IUs, administered once.
16179406|NCT01551303|Drug|Placebo|Matched nasal spray placebo
16179407|NCT01551290|Drug|Infliximab|Form = solution for injection, route = intravenous (IV), Unit = mg/kg, number = 5, administered on = Weeks 0, 2, 6, 14, and 22 and for extension phase: participants treated with infliximab through Week 22 will receive infliximab at Weeks 30, 38, 46 and 54, and will receive placebo at Week 32 and 34.
16179408|NCT01551290|Drug|Placebo|Form = solution for injection, route = IV, administered on = Weeks 0, 2, 6, 14, and 22 and for extension phase: participants treated with placebo through Week 22 will receive infliximab at Weeks 32, 34, 38, 46 and 54 and will receive placebo at Week 30.
16179409|NCT01551277|Other|Placebo-BREATH STACKING|The control group used the same circuit in the intervention group, but without occlusion of the expiratory branch and followed the same protocol to capture the images, ie, basal respiration for five minutes, then three periods of breathing through the mask, the equivalent time the period of technical BS, and five minutes of respiration. The volunteers were instructed to maintain respiration during the period they were using the mask.
16179410|NCT01551277|Other|BREATH STACKING|In the intervention group used a silicon mask, involving the nose and mouth with two outputs, one containing the Wright spirometer MARK 8 analog output and the other was occluded. It was explained that the mask would only allow the air entering during inspiration, and that should inspire the volunteer gradually filling the lungs with air until you feel that completely filled with an average time of 20 seconds, as shown in figure 1 obtained during the method of BS. The end of the technique would be in two situations: when the volunteer asked for it through a hand gesture, or when prearranged by Wright spirometer, was observed by the researcher that there was no change in the inspired volume.
16179411|NCT01551264|Device|Foot Abduction Brace (FAB)|After clubfoot correction, the participants will wear the FAB 23 hours/day for 3 months and then wean to naps and nighttime (8-12 hours/day) for either 2 or 4 years depending on which arm they are in.
16179412|NCT01551238|Dietary Supplement|Differences in protein content of meals|Differences in protein content (energy percent) of meals
16179413|NCT01551238|Dietary Supplement|Differences in protein content of meals|Differences in protein content (energy percent) of meals
16179414|NCT01551225|Drug|Escitalopram|Patients will start at a dosage of 5 mg daily of escitalopram. After the first week of treatment the dosage will be increased to 10 mg daily. During the visits, the dosage can be gradually increased to a maximum of 20 mg daily, depending on the response of the patient.
16179415|NCT01551212|Drug|Everolimus|tablet containing 0.25mg, 0.5mg, 0.75mg or 1.0mg
16179416|NCT01551212|Drug|Tacrolimus|capsule containing 0.5, 1.0, or 5.0mg
16179417|NCT01551212|Drug|Corticosteroids|For patients in all groups, corticosteroids were initiated at or prior to the time of transplantation according to local practice. Corticosteroids may have been used for the duration of the study according to the investigator's discretion, but may not have been eliminated sooner than 6 months post-transplantation.
16179418|NCT01551199|Behavioral|Multiple Channel Exposure Therapy- Veterans|Individual therapy design completed over a 12-week period. The treatment will include psychoeducation about panic attacks and trauma and behavioral and cognitive exposure exercises.
16179419|NCT01551186|Dietary Supplement|Lactobacillus rhamnosus GG|1 capsule containing 10 billion cells of Lactobacillus rhamnosus GG on a twice-daily basis
16179420|NCT01551173|Drug|Fluvastatin sodium|Fluvastatin sodium Extended Release Tablets 80mg
16179421|NCT01551160|Other|A communication and team-working intervention|Medical Emergency Team (MET) briefings and formalised handover between MET staff and patient care teams
16179422|NCT01551147|Drug|ONO-6950|200 mg QD for 8 days
16179423|NCT01551147|Drug|Placebo|Placebo to match ONO-6950 tablets or over-encapsulated Montelukast tablets dosed in a similar manner
16179424|NCT01551147|Drug|Montelukast|10 mg Montelukast QD for 8 days
16179425|NCT01551134|Procedure|Fundoplication|Primary fundoplication
16179426|NCT01551134|Procedure|Fundoplication|Primary fundoplication
16179427|NCT01551121|Other|It will then allow them to intervene at the right time and the right place|The server works 24h/24 and 7d/7 and will send an alert to the care personnel via their computers and personal pagers if it detects an anomaly. Anomaly could be falls, high risk behavior (patient standing up on its bed), abnormal length of stay in the bathroom, prolonged inertia. It will then allow them to intervene at the right time and the right place. Geriatrician can also review images in order to determine the cause of the incident and then act on each patient prevention and care strategy.
16179428|NCT01551108|Behavioral|Intervention: limited behavioral strategies|Parents are given access to a website, formatted for a mobile phone. The website provides parents with a target steps/day goal for their child and parents are instructed to use their mobile phone to access the study website to record their child's step count each night. Parents are also sent monthly healthy nutrition tips via text message targeting the child in order to provide these families with potentially health promoting information.
16179429|NCT01551108|Behavioral|Intervention: advanced behavioral strategies|Parents are given access to a website, formatted for a mobile phone. The website provides parents with a target steps/day goal for their child and parents are instructed to use their mobile phone to access the study website to record their child's step count each night. Parents also receive additional behavioral strategies based on the Social Cognitive Theory. The strategies are delivered through weekly articles posted on the website. Text messages are designed to prompt parents to encourage their child's physical activity, remind parents of behavioral concepts presented in the articles (article tip), and motivate parents to foster behavioral change in their child.
16179430|NCT01551095|Device|PEGJ tube|The self-propelled PEGJ feeding tube
16179431|NCT01551069|Drug|hydroxychloroquine (Z0188)|"Pharmaceutical form:tablet
~Route of administration: oral"
16179432|NCT01551069|Drug|Placebo|"Pharmaceutical form:tablet
~Route of administration: oral"
16179433|NCT01551056|Drug|AC-170 0.24%|1 drop in each eye at 2 separate times during a 14 day period
16179434|NCT01551056|Drug|AC-170 0%|1 drop in each eye at 2 separate times during a 14 day period
16179435|NCT01551043|Biological|CART-19|
16179436|NCT01551030|Drug|Buparlisib|Buparlisib will be administered at a dose of 100 mg orally once daily (two 50 mg capsules) continuously. Intra-patient dose reduction may be required depending on the type and severity of the individual toxicity encountered. Re-staging imaging studies will be performed after every two cycles of treatment (one cycle = 4 weeks). Patients may continue on study as long as they are tolerating therapy and are free of disease progression.
16179874|NCT01547494|Other|Vegan Diet|Vegan diet, which is devoid of animal products and minimal in fat
16179437|NCT01551004|Drug|CRS3123|CRS3123, a methionyl-tRNA synthetase inhibitor, will be supplied in 100 and 200 milligram capsules. Subjects randomized to active drug in Cohorts A through E will receive 100 mg, 200 mg, 400 mg, 800 mg and 1200 mg respectively, as a single oral dose.
16179438|NCT01551004|Other|Placebo|Matching placebo capsules will be given to 2 subjects of each cohort.
16179439|NCT01550978|Device|AnapnoGuard 100 System|AnapnoGuard™ 100 Respiratory Guard System is intended for airway management by oral/nasal intubation while providing continuous endotracheal cuff pressure control using non-invasive measurement and monitoring of carbon dioxide concentration in the subglottic space and evacuation of secretions from above the endotracheal tube's cuff.
16179440|NCT01550965|Biological|Adalimumab|Adalimumab pre-filled syringe, administered by subcutaneous injection
16179441|NCT01550939|Device|Ophthalmic Biometer|One complete biometry examination
16179442|NCT01550926|Drug|120 mg orlistat|2 X60 mg capsule
16179443|NCT01550926|Drug|60 mg orlistat|60 mg orlistat
16179444|NCT01550926|Drug|orlistat experimental dose|experimental
16179445|NCT01550913|Behavioral|Sober Network Interpersonal Psychotherapy (IPT)|IPT will be administered in 16 group 90-minute sessions over 18-20 weeks and 3 individual sessions (at the beginning, middle and end of treatment). These sessions will focus on improving your relationships with others, building sober relationships, setting goals, and increasing coping skills.
16179446|NCT01550913|Other|Treatment as Usual|Women in the treatment as usual condition will either be referred to appropriate treatment in the community or continue their current substance use treatment.
16179447|NCT01550900|Drug|Metformin ER|Starting dose: 500 mg by mouth daily for 1 week with weekly increases of 250 mg daily to target dose of 1000 mg daily.
16179448|NCT01550900|Other|Placebo|Placebo tablets by mouth 1 time a day.
16179449|NCT01550887|Other|No intervention|No intervention will be performed on this study
16179450|NCT01550874|Behavioral|Physical activity behavior-change counselling|Participants in the experimental group will be motivated by augmented behavior modification strategies aiming to increase performance by: (i) having access to the pedometer web page that allows them to view their automatically calculated goals, and (ii) get feedback about performance toward goals.
16179451|NCT01550861|Procedure|in vitro maturation|Maturation of immature oocytes in the laboratory following oocyte retrieval
16179452|NCT01550861|Procedure|Polar Body Biopsy with preimplantation genetic screening|Polar body biopsy is performed on the day that the oocyte is retrieved. Microarray analysis will will be performed and compared with FISH and microarray analysis of day 3 or day 5 biopsy.
16179453|NCT01550848|Drug|Abraxane and Gemcitabine|"ABX (Abraxane) 125 mg/m2，intravenous infusion，30min，day 1, 8, 15
~GEM (Gemcitabine) 800 mg/m2，intravenous infusion，30min，day 1, 8, 15"
16179454|NCT01550835|Device|Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)|Standard of care use of an embolic protection device
16179455|NCT01550835|Device|Emboshield NAV6® embolic protection system (Abbott Vascular, Santa Clara, CA)|Aspiration thrombectomy following stent deployment and prior to embolic protection device removal
16179456|NCT01550822|Other|HEALS|
16179457|NCT01550809|Other|iBolus|Insulin bolus calculated from data obtained through CGM
16179458|NCT01550809|Other|tBolus (traditional bolus)|Insulin bolus dose calculated using the standard procedure based on the insulin-to-carbohydrate ratio
16179459|NCT01550796|Behavioral|Cognitive Training|250 mg d-cycloserine or placebo taken orally one hour before Brain Fitness Program
16179460|NCT01550783|Other|Cervical Papanicolaou Test|Undergo standard of care Pap test screening
16179461|NCT01550783|Other|Cytology Specimen Collection Procedure|Undergo home-based HPV screening
16179462|NCT01550783|Other|Questionnaire Administration|Ancillary studies
16179463|NCT01550783|Procedure|Screening Method|Undergo standard of care Pap test screening
16179464|NCT01550783|Procedure|Screening Method|Undergo home-based HPV screening
16179465|NCT01550770|Drug|propofol|peripheral IV of propofol at increasing dose levels
16179466|NCT01550757|Behavioral|Embedded Peer Mentor|This intervention/condition consists of a formerly homeless individual embedded in the PACT or H-PACT clinic team. This person is responsible for community-based follow-up for homeless patients randomly assigned to him or her. In addition to structured, scheduled meetings with assigned study subjects, the peer mentor will also participate in PACT/H-PACT team meetings and serve as a liaison between the study subject and his or her primary care team. Peer mentors will be hired as VA term employees in Research.
16179467|NCT01550744|Drug|Ustekinumab 45 mg|Form = Injection, route = subcutaneous
16179468|NCT01550744|Drug|Ustekinumab 90 mg|Form = Injection, route = subcutaneous
16179469|NCT01550744|Drug|Placebo|Form = Injection, route = subcutaneous
16179470|NCT01550731|Behavioral|PREPARE website|Advance care planning website and materials plus an advance directive.
16179471|NCT01550731|Behavioral|Advance directive|The control group will only receive an advance directive.
16179472|NCT01550718|Behavioral|ESML-EX (Physical Activity Program)|ESML-EX consists of four weekly 90-minute classes. Each class includes exercises and a brief discussion of a specific health topic.
16179473|NCT01550718|Behavioral|ESML-Social (Social Activity Program)|"ESML-SOCIAL consists of four weekly 90-minute seminars. Each seminar includes discussion of a specific topic, open time for socializing, and a homework assignment to be completed prior to the next session."
16179474|NCT01550705|Drug|Isoniazid|Isoniazid 5 mg/Kg up to 300 mg per day. Oral tablets. 2 months.
16179475|NCT01550666|Behavioral|MOVE|MOVE Program group: MOVE consists of medication follow-up at the CHCS or ATCMHMR and meeting once a week for 9 months with a MOVE trainer in your home. You and your trainer will work on interviews for the first three visits that will talk about negative symptoms, thoughts, attitudes, and social skills that will help each of you develop goals together. Activities will be developed around improving initiation, enjoyment, success and outcome. These activities will be customized to you and will change based on your needs weekly throughout the 9 months
16179476|NCT01550653|Drug|liraglutide|Subcutaneous self-administration of liraglutide(Victoza)by pen. The starting dose is 0.6 mg once daily(day 0 to 7), followed by 1.2 mg once daily (day 8 to 35).
16179477|NCT01550653|Drug|Placebo|
16179478|NCT01550640|Drug|Remifentanil|bolus of remifentanil 1 µg/kg will be given 30 sec before induction to general anesthesia
16187753|NCT01488877|Drug|PF-03882845|3 mg tablet once daily
16179479|NCT01550627|Other|extra fluid/iv fluid supplementation during phototherapy|The study group received an extra intravenous fluid intake of 20% of the total fluid demand per 24 hours of NaCl 0,9% during each two hour period of phototherapy (12h total per day). The extra fluid intake was interrupted during the 12 hours break of phototherapy.
16179480|NCT01550627|Other|Non extra fluid|Control placebo The control group received the previous fluid regime, as intravenous fluid was given constantly, without a specific guideline according to extra fluid intake.
16179481|NCT01550614|Genetic|Alferminogene tadenovec|One-time intracoronary infusion of Ad5FGF-4 (6x10e9 viral particles in buffer)
16179482|NCT01550601|Procedure|bariatric surgery|The longitudinal gastrectomy (sleeve gastrectomy) is a technique of bariatric surgery recently validated (HAS on 2008).It consists of the realization of a partial gastrectomy of 2/3 (Fundus, gastric Body +/- antrum). However, lot of technical disagreements are brought back by expert teams. The most important disagreement concerns the conservation or the exeresis of the gastric antrum. In fact, the conservation of gastric antrum could facilitate the gastric emptying and to decrease the RGO (main complication) and act on the regulations of hormones modulators of the insulino-secretion.
16179483|NCT01550588|Device|Device closure|PFO Amplatzer device closure
16179484|NCT01550588|Drug|Standard medical treatment|Standard Medical management using anti-coagulant therapy
16179485|NCT01550575|Device|Non Boston Scientific Systems|Spinal cord stimulation, RF, IDS etc.
16179486|NCT01550575|Device|Boston Scientific Systems|Spinal cord stimulation, RF, IDS etc
16179487|NCT01550562|Device|Boston Scientific Precision Plus spinal cord stimulation therapy|Epidural spinal cord stimulation (SCS) using the Boston Scientific Precision Plus SCS system
16179488|NCT01550549|Drug|florbetapir F 18|No study drug will be administered in this study - scans previously acquired in in Study A05(NCT00702143) and A07(NCT00857415) will be read
16179489|NCT01550536|Behavioral|Resistance and aerobic exercise|Following baseline measurements, sedentary women were enrolled in a 16-week exercise training program at the YMCA in La Jolla, CA. Exercise occurred 3 times per week, for 1.5 hours each time. Exercise consisted of stretching, 20 minutes of aerobic exercise on elliptical machines, and 3 sets of 10-12 repetitions to failure for each of ten weight lifting exercises: abdominal crunch, arm curl, arm extension, chest press, lat pull-down, leg curl, leg extension, leg press, seated row, and trunk extension. Women started at 65-75% of 1-repetition-maximum, and resistance was increased as necessary to maintain the number of sets and reps and to continue to work to failure. Exercise was monitored by a TechnoGym electronic key system, and trainers instructed and supervised subjects in the gym.
16179490|NCT01550523|Drug|IGF-1R/AS ODN|Patients will receive approximately 10 to 20 million IGF-1R/AS ODN treated tumor cells, encapsulated in diffusion chambers (maximum of 10), and re-implanted in the patient's abdomen within 24 hours after the surgery for a 24 hour period.
16179491|NCT01550523|Device|biodiffusion chamber|The biodiffusion chamber is a simple construct comprised of two Lucite rings sealed on either side with a 0.1u mesh filter (Durapore, the Millipore Corporation). Autologous tumor cells pretreated with the IGF-1R AS ODN and resuspended with 2ug of exogenous IGF-1R AS ODN are added to the chamber. Implantation of the chambers (maximum 10 chambers) occurs 24 hours post surgery for 24 hours.
16179492|NCT01550510|Drug|Ascorbic Acid|3x a week for 9 weeks
16179493|NCT01550510|Drug|Irinotecan|350mg/m2 once a week every 3 weeks
16179494|NCT01550497|Other|supervised spinal stabilization exercises|Supervised or unsupervised exercises to be done for 20 minutes at home, at least 5 times a week for the first 2 weeks and at least 3 times a week after 2 weeks. The supervised weekly physical therapy group will complete 8 weeks of weekly physical therapy. The unsupervised home exercise group will complete 8 weeks of a prescribed home exercise program.
16179495|NCT01550484|Drug|18F-AV-133|222 MBq (6 mCi)
16179496|NCT01550471|Drug|Alvesco/Omnaris, QVAR/Beconase, Placebo/Placebo|Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID Placebo Nasal Spray QD/Placebo Inhalation Aerosol BID
16179497|NCT01550471|Drug|Alvesco/Omnaris, Placebo/Placebo, QVAR/Beconase|Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD, Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID, QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID
16179498|NCT01550471|Drug|QVAR/Beconase, Alvesco/Omnaris, Placebo/Placebo|QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID, Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD, Placebo Nasal Spray QD/Placebo Inhalation Aerosol BID
16179499|NCT01550471|Drug|QVAR/Beconase, Placebo/Placebo, Alvesco/Omnaris|QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID, Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID, Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD
16179500|NCT01550471|Drug|Placebo/Placebo, Alvesco/Omnaris, QVAR/Beconase|Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID, Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD, QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID
16179501|NCT01550471|Drug|Placebo/Placebo, QVAR/Beconase, Alvesco/Omnaris|Placebo Nasal Spray QD and Placebo Inhalation Aerosol BID, QVAR Inhalation Aerosol 40 mcg BID and Beconase AQ Nasal Spray 168 mcg BID, Alvesco Inhalation Aerosol 80 BID and Omnaris Nasal Spray 200 mcg QD
16179502|NCT01550458|Drug|mibefradil|25 mg tablets for oral administration given for 7 days at a total daily dose beginning at 100 mg per day divided into four doses. Doses will be incremented in successive cohorts by 25 mg/day up to 400 mg/day.
16179503|NCT01550458|Other|Placebo|1 out of 6 patients per cohort will receive placebo tablets identical in appearance and number to the active mibefradil arm.
16179504|NCT01550445|Drug|Prednisolone|Those patients who fulfill the entry criteria enter in this prospective controlled trial of steroid withdrawal starting at three months after transplantation
16179505|NCT01550432|Dietary Supplement|Glutathione|1,130 mg/day or 2,260 mg/day for 8 weeks
16179506|NCT01550432|Dietary Supplement|N-Acetylcysteine|600 mg/day or 1,200 mg/day for 8 weeks
16179507|NCT01550432|Other|Placebo|Volume of liquid placebo product comparable to liposomal glutathione and 1 or 2 placebo pills/day.
16179508|NCT01550419|Drug|Atorvastatin|Patients will receive 40mg atorvastatin(one tablet) over night via enteral feeding tube or per os during they stay in ICU at most thirty days.
16179509|NCT01550419|Drug|Placebo|The smell and shape of placebo are the same as atorvastatin
16179875|NCT01547494|Dietary Supplement|mixture of omega3 and vitamins|mixture of omega3 and vitamins
16179511|NCT01550406|Device|Polyglycolic acid (PGA) (Neoveil)|Polyglycolide or Polyglycolic acid (PGA) is a biodegradable, thermoplastic polymer and the simplest linear, aliphatic polyester.
16179512|NCT01550393|Genetic|proteomic profiling|
16179513|NCT01550393|Other|enzyme-linked immunosorbent assay|
16179514|NCT01550393|Other|laboratory biomarker analysis|
16179515|NCT01550393|Other|medical chart review|
16179516|NCT01550380|Drug|BKM120|NVP-BKM120 (BKM120) is an oral pan-class I phosphatidylinositol-3-kinase (PI3K) inhibitor belonging to the 2,6-dimorpholino pyrimidine derivative family.Supplied in 10mg or 50mg capsules. Starting dose: 100mg Once Daily
16179517|NCT01550367|Drug|Hydroxychloroquine|Continuous oral administration (at 600 mg/d) will be initiated prior to the first dose (day -14) given 14 days prior to initiation of the first dose of IL-2 and then daily or twice a day throughout all three treatment courses.
16179518|NCT01550367|Drug|IL-2|600,000 IU/kg IV bolus q 8 hrs x days 1-5 and 15-19 (maximum 28 doses - 14 per 5 day cycle) of each 84-day course
16179519|NCT01550354|Drug|administration of propofol|intravenous administration of propofol 2 mg/kg before intubation
16179520|NCT01550354|Drug|administration of alfentanil|intravenous administration of alfentanil 14 μg/kg before intubation
16179521|NCT01550354|Drug|administration of rocuronium|Intravenous administration of rocuronium 0.3 mg/kg before intubation
16179522|NCT01550341|Drug|Buprenorphine/naloxone|2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
16179523|NCT01550341|Drug|Placebo Oral Tablet|2/0.5, 8/2 sublingual tabs; dosage based on medical assessment; medications taken once per day for 12 months duration.
16179524|NCT01550315|Procedure|Pulsitile Arterial Tonometry (PAT) Protocol|"A blood pressure cuff will be placed on one upper arm (study arm; non-dominant), while the contralateral arm will serve as a control (control arm).
~RH-PAT probes will be placed on one finger (finger II, III, or IV) of each hand (same finger on both hands). The fingers on either side of the one with the probe will be separated using soft sponge rings.
~Continuous recording of pulsatile blood volume responses from both hands will be initiated.
~After a 10-min equilibration period, the blood pressure cuff on the study arm will be inflated to 60 mm Hg above systolic pressure for 5 min. The cuff will then be deflated to induce reactive hyperemia, PAT recording will be stopped."
16179525|NCT01550315|Device|Calf Blood Flow in Reactive Hyperemia (CBF-RH)|Calf blood flow (CBF) will be determined using venous occlusion plethysmography and calibrated mercury strain-gauges during reactive hyperemia after a 5 min of ischemia of the distal limb. Strain-gauges will be applied to the widest part of the non-dominant calf (~10 cm below patella). Participants will remain quietly supine for 10 min with legs elevated on foam pads above the right atrium to achieve stable baseline measurements of CBF. The venous occlusion cuff is inflated for 4 seconds at 8 seconds intervals, while monitoring the change in resistance in the system, pressure inside the measuring cuff, and 5-10 determinations are performed
16179526|NCT01550315|Device|Evaluation of Forearm-Mediated Dilation|The arm will be kept extended and immobilized at heart level. Brachial artery diameter will be measured using a high resolution ultrasonography using a linear array probe with a 5 to 17 MHz frequency range. The brachial artery will be imaged in longitudinal sections, 5-10 cm proximal to placement of an occlusion cuff in the dominant forearm just below the antecubital fossa. The probe will be held with a stereotaxic holder with micrometer movement capabilities.
16179527|NCT01550302|Procedure|Superficial Cervical Plexus Block|"At the end of the lung surgery while subjects are still under general anesthesia, one of the investigators will perform superficial cervical plexus. First, a line extending from the mastoid process to C6 transverse process is drawn. The site of needle insertion is marked at the midpoint of the line connecting the mastoid process with Chassaignac's tubercle of C6 transverse process. After skin cleansing with chlorhexidine prep, using a fan technique with superior-inferior needle redirections, 15 ml of 0.25% bupivacaine will be injected alongside the posterior border of the sternocleidomastoid muscle 2-3 cm below and above the needle insertion site."
16179528|NCT01550302|Drug|Bupivacaine|Single dose of 37.5 mg of bupivacaine subcutaneously
16179529|NCT01550289|Biological|Live, attenuated, recombinant dengue serotype 1, 2, 3, 4 virus|0.5 mL, Subcutaneous
16179530|NCT01550289|Biological|Placebo: NaCl 0.9% solution|0.5 ml, Subcutaneous
16179531|NCT01550276|Other|Manual Therapy|"All patients were assessed in the same conditions before the treatment, after the treatment (at 4 weeks), and at follow-up (after 8 weeks). Four treatment sessions (one session per week). Prior to each treatment session, the physiotherapist performed the vertebral artery test bilaterally, followed by a two-minute neck massage without lubricants and with no proven therapeutic effect, as a placebo for all study groups.
~The SI treatment aims to release the suboccipital muscle spasm10 that maintains the occiput-atlas-axis joint dysfunction. This technique, which was administered for 10 minutes, uses a deep and progressive gliding pressure applied with the fingertips towards the posterior arch of atlas."
16179532|NCT01550276|Other|Manual Therapy|"All patients were assessed in the same conditions before the treatment, after the treatment (at 4 weeks), and at follow-up (after 8 weeks). Four treatment sessions (one session per week). Prior to each treatment session, the physiotherapist performed the vertebral artery test bilaterally, followed by a two-minute neck massage without lubricants and with no proven therapeutic effect, as a placebo for all study groups.
~The OAA manipulation was bilaterally administered and it attempts to restore the motion dysfunction of this complex. It is a structural technique performed on a vertical line along the odontoid process of axis; neither flexion nor extension is used, and lateroflexion is minimal."
16179533|NCT01550276|Other|Manual Therapy|"All patients were assessed in the same conditions before the treatment, after the treatment (at 4 weeks), and at follow-up (after 8 weeks). Four treatment sessions (one session per week). Prior to each treatment session, the physiotherapist performed the vertebral artery test bilaterally, followed by a two-minute neck massage without lubricants and with no proven therapeutic effect, as a placebo for all study groups.
~The combination of both treatments aims to determine whether this combination has greater effects than the separate application of each treatment. After receiving the treatment, the subjects in the experimental groups stayed for five minutes in the supine resting position, in neutral ranges of cervical flexion, extension, lateral flexion and rotation."
16179597|NCT01549795|Radiation|45 Gy external radiations|45 Gy in 30 fractions, 1,5 Gy twice a day) and 5-FU iv infusion- 3 week treatment
16179598|NCT01549795|Radiation|Endoluminal bile duct Brachytherapy|Brachytherapy (20 Gy a 1 cm in 20-25h) - administered 2 weeks after radiotherapy completion
16179534|NCT01550276|Other|Placebo control|"All patients were assessed in the same conditions before the treatment, after the treatment (at 4 weeks), and at follow-up (after 8 weeks). Four treatment sessions (one session per week). Prior to each treatment session, the physiotherapist performed the vertebral artery test bilaterally, followed by a two-minute neck massage without lubricants and with no proven therapeutic effect, as a placebo for all study groups.
~The control group received four sessions of placebo treatment, followed by ten minutes of resting position."
16179535|NCT01550250|Behavioral|Night-time compression system garment|Night-time compression system garment 8 hours per night for a minimum of 5 nights per week.
16179536|NCT01550250|Behavioral|Day-time compression sleeve|Standard care for lymphedema maintenance. Day-time compression sleeve with or without a glove/ gauntlet, providing a minimum of 30 mm Hg of pressure, for twelve hours per day, each day of the week.
16179537|NCT01550237|Radiation|radiotherapy daily verification reduced safety margins|curative radiotherapy to 78 Gy in 39 fractions with daily CT position verification and reduced safety margins (7mm)
16179538|NCT01550237|Radiation|radiotherapy weekly verification standard safety margins|curative radiotherapy to 78 Gy in 39 fractions with weekly orthogonal position verification and standard safety margins (10-15 mm)
16179539|NCT01550224|Drug|Temozolomide|An alkylating agent administered for induction per standard of care at 200 mg/m²/day for 7days.
16179540|NCT01550224|Drug|Vorinostat|A synthetic hydroxamic acid derivative with antineoplastic activity administered for both groups at 500 mg orally 3 times daily for 3 days prior to Temozolomide 200 mg/m²/day.
16179541|NCT01550211|Device|Magnetoencephalograph (MEG)|Conducting a brain scan during a series of perceptual and linguistic tasks
16179542|NCT01550198|Device|Advanced hemodynamic monitoring|Comprehensive advanced hemodynamic monitoring
16179543|NCT01550185|Drug|eltrombopag olamine|Given PO
16179544|NCT01550185|Procedure|standard follow-up care|Receive standard care
16179545|NCT01550172|Behavioral|Sleep Behavioral Therapy A and NHMS|"The night home monitoring system provides caregivers with reliable alerts and information regarding the whereabouts of the person with dementia during the night.
~Sleep behavioral therapy A uses a combination of cognitive exercises and behavior adjustments."
16179546|NCT01550172|Behavioral|Sleep Behavioral Therapy B and NHMS|"The night home monitoring system (NHMS) provides caregivers with reliable alerts and information regarding the whereabouts of the person with dementia during the night.
~Sleep behavioral therapy B uses primarily behavioral adjustments."
16179547|NCT01550146|Drug|Dexamethasone acetate|iv. dexamethasone 0.1 mg/kg
16179548|NCT01550146|Drug|Placebo|iv. Normal Saline 0.1 ml/kg
16179549|NCT01550133|Behavioral|Learned: Non-nutritive beverage to Non-nutritive beverage|For the learning phase of the experiment, random allocation will assign about 15 participants to consume a beverage product made with non-nutritive sweetener everyday for two weeks.Half of these participants will then be tested against a non-nutritive beverage.
16179550|NCT01550133|Behavioral|Learned: Nutritive solid to Nutritive solid|For the learning phase of the experiment, random allocation will assign about 15 participants to consume a solid food product made with nutritive sweetener everyday for two weeks. Half of these participants will then be tested against a nutritive solid.
16179551|NCT01550133|Behavioral|Learned: Nutritive beverage to Nutritive beverage|For the learning phase of the experiment, random allocation will assign about 15 participants to consume a beverage product made with nutritive sweetener everyday for two weeks. Half of these participants will then be tested against a nutritive beverage.
16179552|NCT01550133|Behavioral|Not Learned: Non-nutritive solid to Nutritive solid|For the learning phase of the experiment, random allocation will assign about 15 participants to consume a solid food product made with non-nutritive sweetener everyday for two weeks. Half of these participants will then be tested against a nutritive solid.
16179553|NCT01550133|Behavioral|Not Learned: Nutritive beverage to Non-nutritive beverage|For the learning phase of the experiment, random allocation will assign about 15 participants to consume a beverage food product made with nutritive sweetener everyday for two weeks. Half of these participants will then be tested against a non-nutritive beverage.
16179554|NCT01550133|Behavioral|Not Learned: Non-Nutritive solid to Non-nutritive solid|For the learning phase of the experiment, random allocation will assign about 15 participants to consume a solid food product made with nutritive sweetener everyday for two weeks. Half of these participants will then be tested against a non-nutritive solid.
16179555|NCT01550133|Behavioral|Not Learned: Non-nutritive beverage to Nutritive beverage|For the learning phase of the experiment, random allocation will assign about 15 participants to consume a beverage food product made with non-nutritive sweetener everyday for two weeks. Half of these participants will then be tested against a nutritive beverage.
16179556|NCT01550133|Behavioral|Not Learned: Non-Nutritive solid to Non-Nutritive Solid|For the learning phase of the experiment, random allocation will assign about 15 participants to consume a solid food product made with non-nutritive sweetener everyday for two weeks. Half of these participants will then be tested against a non-nutritive solid.
16179557|NCT01550107|Drug|Allopurinol|300mg b.d for 24 weeks
16179558|NCT01550107|Drug|Lactose tablets|matched placebo tablets b.d
16179559|NCT01550081|Other|Rate of perceived exertion|Exercise intensity controlled by Borg scale
16179560|NCT01550081|Other|Heart rate monitor|Exercise intensity controlled by heart rate monitors
16179561|NCT01550068|Diagnostic Test|Echocardiography|
16179562|NCT01550055|Drug|CMAB009 plus Irinotecan|Combined with irinotecan 180 mg/m2 every 2 weeks, CMAB009 400 mg/m2 day 1 followed by 250 mg/m2 weekly till disease progression
16179563|NCT01550055|Drug|Irinotecan-only and sequential-CMAB009|First, irinotecan 180 mg/m2 every 2 weeks till PD occured, discontinue it; then, CMAB009 400 mg/m2 day 1 followed by 250 mg/m2 weekly till disease progression.
16179564|NCT01550029|Behavioral|Counseling/Healthy Lifestyle|"A trained counselor will meet with subjects for approximately 60 minutes each week during the 12-week treatment period to provide support for quitting and to help develop knowledge and skills for quitting. Also, the National Cancer Institute's Clearing the Air guide to smoking cessation will be given to subjects. Some specific areas of focus for this intervention are developing a better understanding of reasons for smoking and the consequences of tobacco use and identifying ways for establishing a healthier lifestyle."
16179599|NCT01549795|Drug|Capecitabine|Capecitabine - administered till liver transplantation
16179565|NCT01550029|Behavioral|Counseling/Managing Mood|"A trained counselor will meet with subjects for approximately 60 minutes each week during the 12-week treatment period to provide support for quitting smoking and to help develop knowledge and skills for quitting. Also, subjects will receive the National Cancer Institute's Clearing the Air guide to smoking cessation. Some specific areas of focus for this intervention are managing negative moods without smoking and overcoming other obstacles to quitting."
16179566|NCT01550016|Other|Observation|Clinical follow-up and laboratory investigations.
16179569|NCT01549990|Drug|Sevoflurane|maintenance of general anesthesia with sevoflurane
16179570|NCT01549990|Drug|desflurane|maintenance of general anesthesia with desflurane
16179571|NCT01549977|Drug|Febuxostat|Febuxostat tablets
16179572|NCT01549977|Drug|Placebo|Febuxostat placebo-matching tablets
16179573|NCT01549964|Drug|Fasiglifam (TAK-875)|Fasiglifam (TAK-875) tablets
16179574|NCT01549964|Drug|Sitagliptin|Sitagliptin tablets
16179575|NCT01549964|Drug|Placebo|Placebo-matching tablets
16179576|NCT01549951|Drug|Orteronel+Prednisone|Orteronel 400-mg plus prednisone 5-mg will be administered BID orally continuously throughout the treatment cycle of the study.
16179577|NCT01549938|Dietary Supplement|Cholecalciferol|20,000 IU cholecalciferol capsule, given once weekly for 16 weeks.
16179578|NCT01549938|Dietary Supplement|Placebo|Microcellulose capsule identical in appearance to treatment
16179579|NCT01549925|Other|Standard Surgical resection|standard surgical resection using clamps and surgical ligatures
16179580|NCT01549925|Device|LIGASURE|resection using the FDA-approved LIGASURE device during omentectomy and resection of the recto-sigmoid portion of the colon
16179581|NCT01549899|Behavioral|In-person Cognitive Behavioral Therapy of Insomnia|In-person CBTi was be provided by a master's or doctoral level mental health counselor (e.g., social worker or psychologist). This treatment consisted of 6-sessions and included the same efficacious and commonly used modules of CBTi (i.e., sleep education & hygiene, stimulus control, progressive muscle relaxation, sleep restriction, and cognitive therapy).
16179582|NCT01549899|Behavioral|Internet Cognitive Behavioral Therapy of Insomnia|The ICBTi treatment is an online protocol developed by the National Center for Telehealth and Technology, with the PI (DJT) as the subject matter expert. The treatment consists of the same components as the in-person CBTi, but their mode of delivery was considerably different due to the constraints of its automated, online format. Each of the six ICBTi sessions was divided into lessons covering different aspects of each of the components. The lessons were presented as audio recordings accompanied by visual graphics and animations. For several lessons, interactive components were included, such as games, quizzes, and prompts for participants to schedule healthy sleep habits.
16179583|NCT01549886|Drug|Y-90-Zevalin|Day 8 - Y-90-Zevalin 0.4 mCi/kg 10-minute intravenous push
16179584|NCT01549886|Drug|Moxtezafin Gadolinium|"Day 1-4 Motexafin gadolinium 5 mg/kg intravenously once daily, followed in one hour (Day 1 only) by Day 1 Rituximab 250 mg/m^2 intravenous infusion.
~Day 8-11 Motexafin gadolinium 5 mg/kg intravenously once daily"
16179585|NCT01549886|Drug|Rituximab|Day 1 and Day 8: Rituximab 250 mg/m^2 intravenous infusion
16179586|NCT01549873|Drug|propofol|Propofol adjusted to maintain the bispectral index at 40-60.
16179587|NCT01549873|Drug|Desflurane|Desflurane adjusted to maintain the bispectral index at 40-60.
16179588|NCT01549860|Device|MIST Therapy|Non-contact low frequency ultrasound therapy
16179589|NCT01549847|Drug|L-carnitine and piracetam|L-carnitine/piracetam (990mg/810mg) PO BID
16179590|NCT01549847|Drug|Placebo|Placebo PO BID
16179591|NCT01549834|Drug|ABT-126|Low Dose
16179592|NCT01549834|Drug|ABT-126|High Dose
16179593|NCT01549834|Drug|placebo|Placebo
16179594|NCT01549808|Other|mobilization|The patients are mobilized according to the mobilization protocol. The training concist of balance, muscle strength and staying power. Before the mobilization the patients ability to mobilization is evaluated according to contradictions and pre screening (exh 2,3). The primary nurse and the physiotherapist evaluate and allocate patients to mobilization stage. All patients is mobilized minimum 3 times at day (exh 2) and is supported as a minimum of two persons. Before each activity the patient must have a rest period of ½ hour. The patients security during mobilization is registried (exh 1,3). The mobilization stops if patients security is affected. During walk patients is followed by a chair, in order to prevent or cushion a fall.
16179595|NCT01549808|Other|mobilization|sitting, standing and walking
16179596|NCT01549795|Procedure|Liver transplantation|Liver transplantation using classic technique and avoiding proximal ilum dissection. The donor hepatic artery will be anastomosed to a jump graft connected to the Aorta. In case of positive margin of the bile duct at a frozen section analysis the liver transplant will be performed after an adjunctive pancreatodudodenctomy
16179715|NCT01548872|Drug|HTK solution|50 ml/kg bolus in 2 minutes
16179600|NCT01549795|Procedure|Pre liver transplantation laparoscopic hand assisted staging|Pre liver transplantation laparoscopic hand assisted staging for sampling hepatic artery lymph nodes and assessing peritoneal disease.
16179601|NCT01549782|Dietary Supplement|Inulin and Fructo-oligosaccharide|6 gr daily of fibre (50% inulin and 50% FOS). Patients underwent a 1-week run-in period before starting RT and continued taking the same products throughout the treatment course, until three weeks after RT was finished.
16179602|NCT01549782|Dietary Supplement|Maltodextrine|6 gr daily of maltodextrine. Patients underwent a 1-week run-in period before starting RT and continued taking the same products throughout the treatment course, until three weeks after RT was finished.
16179603|NCT01549769|Drug|Bardoxolone Methyl|Oral, once daily
16179604|NCT01549756|Behavioral|bulletin board and teleophone depth interview|qualitative based research
16179605|NCT01549743|Drug|Celecoxib|Celecoxib 200mg will be administered orally twice a day for 3 days
16179606|NCT01549743|Drug|Rebamipide|Rebamipide 100mg will be administered orally three times a day for 3 days
16179607|NCT01549743|Drug|Celecoxib plus Rebamipide|"Celecoxib plus Rebamipide same way as arm: celecoxib and arm: rebamipide"
16179608|NCT01549730|Procedure|18F-Fluoroazomycin Arabinoside (18F-FAZA)|A PET scan is an imaging test that uses special radioactive dyes to measure different aspects of how your cancer acts. In this study, a dye called 18F-Fluoroazomycin Arabinoside (18F-FAZA) will be used to measure hypoxia levels in tumours. Health Canada has not approved FAZA for general use, but has approved it for use in this study.
16179609|NCT01549717|Device|Fitting of a wireless telemetry device|Fitting of a Philips Intellivue Trx + SpO2 telemetry device. To be worn throughout patient stay except if being monitored using a standard bedside monitor or bathing.
16179610|NCT01549704|Drug|Ropivacaine|"Arm RP is receiving 30 ml of ropivacaine 7,5 mg/ml at first blockade (ACB) and after 45 minutes another blockade (ACB) with placebo (saline 30 ml).
~Arm PR is receiving 30 ml of placebo (saline) at first blockade (ACB) and after 45 minutes another blockade (ACB)with ropivacaine."
16179611|NCT01549704|Drug|Saline|please see intervention description for ropivacaine
16179612|NCT01549691|Drug|Zopiclone|7.5 mg before sleep, the evening before surgery
16179613|NCT01549691|Drug|Alprazolam|0.5 mg at awakening, the day of surgery
16179614|NCT01549691|Drug|placebo|given night before surgery and at awakening, the day of surgery
16179615|NCT01549678|Other|Total contact insole|EVA insole shaped on patient´s foot.
16179616|NCT01549678|Other|placebo insole|EVA insole flat
16179617|NCT01549665|Biological|Human umbilical cord blood-derived mesenchymal stem cells|1st infusion(1x1,000,000 hMSC/kg)IV, 2nd infusion(2x1,000,000 hMSC/kg)IV and 3rd infusion(3x1,000,000 hMSC/kg)IV if no complete response at 28 days.
16179618|NCT01549652|Drug|Ondansetron|Ondansetron 8 mg oral tablet
16179619|NCT01549652|Drug|Placebo|Placebo to Match Ondansetron
16179620|NCT01549652|Drug|Morphine|Sustained release oral morphine, beginning at 30 mg/d, titrated up by 15 mg/d every 2 days until adequate analgesia is achieved
16179621|NCT01549652|Drug|Naloxone 0.4 mg/70 kg|Naloxone 0.4 mg/70 kg intravenous
16179622|NCT01549652|Drug|Naloxone 0.8 mg/70 kg|Naloxone 0.8 mg/70 kg intravenous
16179623|NCT01549626|Dietary Supplement|Defatted flaxseed flour|30g defatted flaxseed flour per day for breakfast
16179624|NCT01549626|Dietary Supplement|Golden flaxseed flour|30 grams of golden flaxseed flour per day for breakfast
16179625|NCT01549626|Dietary Supplement|Whole brown flaxseed flour|30 grams of whole brown flaxseed flour per day for breakfast
16179626|NCT01549613|Drug|Daptomycin|• Daptomycin will be given in a one-time dose of 4mg/kg in a one-time dose to be infused over 2 minutes at the initiation of patient therapy in the RDTC cellulitis protocol.
16179627|NCT01549613|Drug|Vancomycin|• Vancomycin will be given in a dose of 15mg/kg at baseline and again at 12 hours to be infused over 1 to 2 hours.
16179628|NCT01549600|Dietary Supplement|psyllium|1 level tablespoon (~ 5.1 g psyllium husk in the psyllium product) mixed with at least 8 ounces of water, taken twice daily
16179629|NCT01549600|Dietary Supplement|Microcrystalline Cellulose|1 level tablespoon (~ 1.18 g MCC in the MCC product) mixed with at least 8 ounces of water, taken twice a day
16179630|NCT01549587|Drug|0.243% sodium fluoride|dentifrice: brush thoroughly twice daily
16179631|NCT01549587|Device|toothbrush|brush thoroughly twice daily
16179632|NCT01549587|Device|dental floss|floss the whole mouth once daily
16179633|NCT01549587|Drug|0.454% stannous fluoride|dentifrice: twice daily brush thoroughly for 2 minutes
16179634|NCT01549587|Device|toothbrush|twice daily brush thoroughly for 2 minutes
16179635|NCT01549587|Drug|0.07% Cetylpyridinium chloride|mouth rinse: rinse with 20 mL of mouth rinse for 30 seconds twice daily
16179636|NCT01549587|Device|dental floss|floss the whole mouth once daily
16179637|NCT01549574|Drug|crizotinib|Each subject in Treatment A will receive a 250 mg single oral dose of crizotinib administered in a fasted state as 1x 250 mg Formulated Capsule on Day 1 and each subject in Treatment B will receive a 250 mg single oral dose of crizotinib administered in a fasted state as 1x 250 mg Formulated Capsule on Day 5
16179638|NCT01549574|Drug|esomeprazole|Each subject in Treatment B will receive 40 mg daily dose of esomeprazole from Day 1 to Day 5
16179639|NCT01549561|Behavioral|Parent Training|16 weeks of parent training led by a trained group facilitator
16179640|NCT01549561|Behavioral|Youth Skills Training|16 weeks of one-on-one sessions with a trained youth skills coach
16179641|NCT01549548|Drug|Ponatinib|Patients will receive Ponatinib 45 mg by mouth as a single daily dose on an empty stomach (no food 2 hours prior to and after dosing) on day 1 and continuous once-daily dosing everyday thereafter. Each patient will receive daily Ponatinib until disease progression, unacceptable toxicity, or withdrawal of consent.
16179642|NCT01549535|Device|Colonoscopy done with:PeerMedical System and Olympus/Pentax/Fuji colonoscopy system|endoscopic diagnosis, treatment and video observation of the digestive tract, endoscopy and endoscopic treatment within the lower digestive tract (including the anus, rectum, sigmoid colon, colon and ileocecal valve) of adults patients
16179643|NCT01549522|Behavioral|bulletin board or telephone depth interview (TDI)|experiential based research. anonymous participation.
16179644|NCT01549522|Behavioral|interview regarding experiences and opinions as to condition and treatment|not a drug trial. experential/opinion based research.
16179645|NCT01549509|Biological|VRC-HIVADV014-00-VP Vaccine|All participants will receive one injection in their upper arm of 1 x 10^10 particle units (PU)/mL of VRC-HIVADV014-00-VP at study entry.
16179646|NCT01549496|Drug|Amlodipine|amlodipine 2.5 mg QD
16179647|NCT01549496|Drug|Diltiazem|diltiazem 120 mg qd
16179648|NCT01549470|Biological|VRC-HIVDNA009-00-VP|Administered as a 4 mg/mL dose by IM injection in the deltoid muscle using the Biojector 2000 needle-free injection management system.
16179649|NCT01549470|Biological|Placebo vaccine|Administered as a 1-mL dose by IM injection in the deltoid muscle using the Biojector 2000 needle-free injection management system.
16179650|NCT01549457|Other|Cell phone text messages|Participants in the intervention arm will receive weekly text messages from the TB control clinic asking how they are.
16179651|NCT01549444|Other|presence of maternal risk factor for hypertension|
16179652|NCT01549431|Drug|Panobinostat|"Panobinostat will be supplied as 5-mg or 20-mg pink/opaque-colored, hard gelatin capsules. Panobinostat is administered orally three times per week.
~Standard 3+3 design
~3 out of 4 weeks"
16179653|NCT01549431|Drug|Carfilzomib|"Carfilzomib in Cycle 1 will be initiated intravenously at 20 mg/m² on Days 1 and 2 and escalated to 27 mg/m² for Days 8, 9, 15, and 16 of Cycle 1 and for the duration of treatment.
~Standard 3+3 design
~Days 1/2, 8/9 and 15/16 every 4 weeks"
16179654|NCT01549431|Drug|Dexamethasone|Dexamethasone (4 mg) must be given prior to each carfilzomib infusion during Cycle 1. Dexamethasone pre-dose should continue through Cycle 2 if fever is observed post-dose, Cycle 2 Day 1, or thereafter associated with the infusion of carfilzomib.
16179655|NCT01549418|Drug|Aspirin (ASA)|Usage or withdrawal of aspirin (75mg daily per os) 7 days before and 14 days after polypectomy
16179656|NCT01549418|Drug|Placebo|
16179657|NCT01549405|Other|İntercostal nerve block|Nerve block group was administered two levels intercostal block (11 and 12th ribs) with 0.5% bupivacaine with epinephrine before surgery.
16179658|NCT01549392|Device|DECT|DECT at tumor progression and 3 months later
16179659|NCT01549392|Device|MR spectroscopy|MR spectroscopy at tumor progression and 3 months later
16179660|NCT01549379|Radiation|Dynamic Contrast Enhanced CT scan|The neck will be scanned using 120 kVp, 50 mAs, 8 x 5 mm slices at intervals of 2.8 - 3.0 s for 3 min. Contrast (e.g. Visipaque 320) at a dosage of 0.7 ml/kg is injected at 4 ml/s through an antecubital vein after a delay of 6 s from start of scanning.
16179661|NCT01549366|Device|Aspen Spinous Process Fixation Device|The Aspen device will be placed as posterior fixation to Lateral Lumbar Interbody Fusion (LLIF) or Anterior Lumbar Interbody Fusion (ALIF)
16179662|NCT01549366|Device|Pedicle Screws|Pedicle Screws will be placed as posterior fixation to Lateral Lumbar Interbody Fusion (LLIF) or Anterior Lumbar Interbody Fusion (ALIF)
16179663|NCT01549353|Behavioral|gum chewing|
16179664|NCT01549327|Other|Oncology Interactive Navigator|
16179665|NCT01549327|Other|Routine Care|
16179666|NCT01549301|Drug|Filgrastim|filgrastim, single dose, s.c., dosage: 5 mcg/kg
16179667|NCT01549301|Drug|Filgrastim|filgrastim, single dose, s.c., dosage: 10 mcg/kg
16179668|NCT01549301|Drug|Filgrastim|Filgrastim, i.v., single dose, dosage: 5 mcg/kg
16179669|NCT01549301|Drug|Filgrastim|Filgrastim, i.v., single dose, dosage: 10 mcg/kg
16179670|NCT01549288|Behavioral|modified Atkins diet|Carbohydrate restricted to 10 g/day (18-36 months) and 5 g/day (9-18 months), fat intake encouraged, proteins unrestricted
16179671|NCT01549288|Other|no dietetic input|continuation of anti-epileptic medication without any dietetic input
16179672|NCT01549262|Device|"Observe embryo development with Unisense FertiliTech A/S (EC Certificte DGM - 673)"|Observation of exact timing of embryo cleavages together with other morphology dynamics parameters.
16179673|NCT01549262|Device|Observe embryo development|Observe embryo development in the traditional manner
16179674|NCT01549249|Device|optical coherence tomography|spectral-domain optical coherence tomography
16179675|NCT01549236|Drug|Benznidazole 12,5mg or 100mg|"All 80 subjects recruited into the study will receive treatment with:
~- Benznidazole (Laboratório Farmacêutico do Estado de Pernambuco -LAFEPE - Recife - Brazil; tablet 12.5mg or 100mg), 7.5 mg/Kg/day PO (actual range of 5.5-8.5 mg/Kg/d), divided in two daily doses, for 60 days."
16179676|NCT01549223|Drug|Oxytocin Infusion|500 mL bag of oxytocin (30 IU/500 mL) to be connected to the IV, and controlled per obstetrician request.
16179677|NCT01549223|Drug|Oxytocin Bolus|3 IU oxytocin and be given IV at time of baby delivery (Time 0). Up to two additional syringes can be given at 3 and 6 mins until uterine tone adequate (as per obstetrician on graded scale).
16179678|NCT01549171|Drug|Iloprost|supplement in culture medium during culture in the lab. The concentration is 1 uM.
16179679|NCT01549171|Other|normal saline|Supplement with vehicle only no Iloprost.
16179680|NCT01549158|Drug|torasemide-PR|Single oral dose of torasemide PR 10 mg
16179681|NCT01549158|Drug|Furosemide-IR|Single oral dose of furosemide IR 40 mg
16179682|NCT01549158|Drug|torasemide-IR|Single oral dose of torasemide IR 10 mg
16179683|NCT01549145|Device|Nimbus Multifunctional Stimulator|A Multifunctional Stimulator (Nimbus by Newmedic, Hemodia) for clinical use. The stimulator is also dedicated for Electrical Promontory Stimulation (EPS)
16179684|NCT01549119|Biological|VAC-3S|Comparison of different doses of vaccine. Liquid form Volume: 0.5 mL - 2 X 0.5 mL for double-dose arm 3 vaccinations at one month apart
16179685|NCT01549119|Biological|Placebo|Comparison with experimental vaccine
16179686|NCT01549106|Drug|IPI-145|Single ascending dose up to 6 cohorts; multiple ascending dose up to 4 cohorts; food effect arm; ketoconazole drug interaction study
16179687|NCT01549106|Drug|Placebo|Single ascending dose up to 6 cohorts; multiple ascending dose up to 4 cohorts; food effect arm
16179688|NCT01549093|Drug|Gemcitabine,Carboplatin,Endostar|Gemcitabine(G):1000mg/m2 iv on d1,8 q3w; Carboplatin(C):AUC 5 iv on d1 q3w; Endostar:7.5 mg/m2 Continued Pumping into vein with saline,Each pump use 48hours and the dosage is 7.5mg/m2*2 ,on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle,Continued using 2-6cycles.
16179689|NCT01549093|Drug|Gemcitabine(G) Carboplatin(C) Endostar|Gemcitabine(G):1000mg/m2 iv on d1,8 q3w; Carboplatin(C):AUC 5 iv on d1 q3w; Endostar:7.5 mg/m2 injecting into vein for 4 hours with saline on day 1 to day 14, discontinuancing for 7 days and 21 days is one cycle.Continued using 2-6cycles
16179716|NCT01548872|Drug|crystalloid cardioplegia solution|30 ml/kg bolus in two minutes
16179690|NCT01549093|Drug|Gemcitabine(G) Carboplatin(C)|Gemcitabine(G):1000mg/m2 iv on d1,8 q3w; Carboplatin(C):AUC 5 iv on d1 q3w; 21 days is one cycle.Continued using 2-6cycles
16179691|NCT01549080|Drug|Yisuishengxue Granule|Yisui Shengxue Granules，produced by pharmaceutical factory of Guang'anmen Hospital, China Academy of Chinese Medical Sciences, is made from the herbs of Shan Zhu Yu (Fructus Corni), He Shou Wu (Radix Polygoni Multiflori), Shu Di Huang (Radix Rehmanniae Preparata), Huang Qi (Radix Astragali) and etc.Yisui Shengxue Granules：12g/bag， Registration Number：20110602； Yisui Shengxue Granules replacer (placebo)：12g/bag，Registration Number：20110519；Treatment group：Yisui Shengxue Granules，1 bag, tid, po； Control group: Yisui Shengxue Granules replacer (placebo), 1 bag, tid, po; Intervention for 12 weeks. Follow-up 3 months later after stopping the drug intervention.
16179692|NCT01549054|Drug|10-mg dose of E5501 2G tablet|Treatment A: Single 10-mg dose of E5501 2G tablet
16179693|NCT01549054|Drug|10-mg dose of E5501 cyclodextrin oral solution|Treatment B: Single 10-mg dose of E5501 cyclodextrin oral solution
16179694|NCT01549054|Drug|10-mg dose of E5501-P21% powder|Treatment C: Single 10-mg dose of E5501-P21% powder oral suspension
16179695|NCT01549054|Drug|10-mg dose of E5501 lipid-based oral|Treatment D: Single 10-mg dose of E5501 lipid-based oral suspension
16179696|NCT01549041|Drug|Asenapine 10 mg daily in the evening|The total daily dose of Asenapine will be given once daily in the evening
16179697|NCT01549041|Drug|Asenapine 5 mg twice daily|Asenapine will be given in two doses, 5 mg in the morning and 5 mg in the evening, daily
16179698|NCT01549028|Behavioral|mobile-based PR program.|Patients will be trained and monitored by mobile-based pulmonary rehbailitation program. By mobile, patients could undergo exercise training at home and the information of training parameters will be send to investigator. Investigator could monitor these patients by mobile. Patients will return to visit physian and receive six-minutes walking test to measure outcomes 3 months and 1 year later after mobile-based pulmonary rehabilitation program.
16179699|NCT01549015|Other|oral administration of Sodium [1,2-13C]-Acetate|single dose of 0.55 mg/kg 13C-Acetate given orally of via a naso-gastric tube
16179700|NCT01549002|Drug|Intranasal Fentanyl|Drug: Fentanyl 50 micrograms/mL Dosage: 2 micrograms per kilogram (maximum 100 micrograms) Drug delivery: Intranasal via mucosal atomization device (MAD® Nasal, Wolfe Tory Medical Inc., Salt Lake City, UT) Frequency: one-time dose
16179701|NCT01549002|Drug|Intravenous Morphine|Drug: Morphine Dosage: 0.1 milligrams/kilogram (maximum 8 milligrams) Drug delivery: Slow IV push Frequency: one-time dose
16179702|NCT01548963|Procedure|Intensive glycemia control|Blood glucose levels will be maintained by continuous insulin infusion (Actrapid, Novo Nordisk A/S, Bagsvaerd, Danemark - 50 IU/50 ml FR) within normoglycemia limits (4.4 - 6.1 mmol/l)
16179703|NCT01548950|Drug|Sildenafil singly or in association with Bosentan|Sildenafil, 1-4 mg/Kg/day (6-hour intervals) preoperatively, until development of pulmonary congestion (generally 1-4 weeks) or preoperatively, for 10-12 months, in association with bosentan (15.6-62.5 mg b.i.d.) if pulmonary congestion does not develop. Surgery will be performed at 1-4 weeks (short-term treatment) or at 10-12 months (medium-term treatment) if operability criteria are met (catheterization). In both cases (short and medium-term treatments), the drug or drugs will be kept for 6 months postoperatively, when final catheterization will be performed for efficacy testing.
16179704|NCT01548937|Drug|I-123 ADAM|"This study will recruit a total of 40 evaluable subjects (20 cognitively depressive, and 20 AD depressive), Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping.
~Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events."
16179705|NCT01548924|Drug|Dovitinib|Orally Dovitinib once a day and a five-day regimen of administration and then two days resting, in cycles of 28 days.
16179706|NCT01548924|Drug|Dovitinib + Paclitaxel|"Paclitaxel (80 mg/m2) : 1, 8, 15 and 21.
~Dovitinib (100 mg, 200 mg,300 mg, 400 mg or500 mg; it depends on the level of the Phase 1 study in each patient): five days of treatment / two days off.
~Each cycle will last for 28 days."
16179707|NCT01548911|Drug|gemtuzumab ozogamicin|Given IV
16179708|NCT01548911|Other|laboratory biomarker analysis|Correlative studies
16179709|NCT01548898|Device|Nd-YAG laser|All patients received 5 sessions (4 weeks apart) of long pulsed nd-YAG laser assisted hair removal on the affected area, emitting 1064 nm, with a fluence of 35-45 J/cm2 and pulse duration 10-30 msec adjusted to skin type and hair thickness. Laser was applied to all papules and plaques.
16179710|NCT01548885|Device|CONTOUR® NEXT EZ BGMS|Study staff performed Blood Glucose (BG) testing with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). Performance of CONTOUR® NEXT EZ BGMS was evaluated across the glucose range of the BGMs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
16179711|NCT01548885|Device|FreeStyle Freedom Lite® BGMS|Study staff performed Blood Glucose (BG) testing with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). Performance of FreeStyle Freedom Lite® BGMS was evaluated across the glucose range of the BGMs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
16179712|NCT01548885|Device|ACCU-CHEK® Aviva BGMS|Study staff performed Blood Glucose (BG) testing with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). Performance of ACCU-CHEK® Aviva BGMS was evaluated across the glucose range of the BGMs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
16179713|NCT01548885|Device|TRUEtrack® BGMS|Study staff performed Blood Glucose (BG) testing with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). Performance of TRUEtrack® BGMS was evaluated across the glucose range of the BGMs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
16179714|NCT01548885|Device|OneTouch® Ultra®2 BGMS|Study staff performed Blood Glucose (BG) testing with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). Performance of OneTouch® Ultra®2 BGMS was evaluated across the glucose range of the BGMs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
16179717|NCT01548859|Drug|Midazolam|0.2 mg/kg/saat continuous infusion of midazolam received during anaesthesia
16179718|NCT01548859|Drug|Sevoflurane|end tidal concentration of % 0,5-8
16179719|NCT01548846|Radiation|Tomotherapy|Patients receive radiotherapy by Tomotherapy for 7 weeks at the ENT
16179720|NCT01548833|Device|Delefilcon A contact lens|Silicone hydrogel contact lens for single use, daily disposable wear.
16179721|NCT01548833|Device|Narafilcon A contact lens|Silicone hydrogel contact lens for single use, daily disposable wear.
16179722|NCT01548833|Device|Filcon II 3 contact lens|Silicone hydrogel contact lens for single use, daily disposable wear
16179723|NCT01548807|Drug|Everolimus (RAD001)|
16179724|NCT01548794|Procedure|spinal anesthesia|To receive 2 ml heavy bupivacaine + 0,6 ml saline
16179725|NCT01548794|Procedure|spinal anesthesia|To receive 2ml bupivacaine +0,6 ml 1% lidocaine for spinal anesthesia.
16179726|NCT01548794|Procedure|infiltration anesthesia|To receive step by step local infiltration anesthesia as described by the Lichtenstein Institute.
16179727|NCT01548781|Behavioral|Impairment-based robotic intervention for reaching function|All participants will undergo 8 weeks of reaching practice in the ACT3D. Frequency and duration will be matched at three 1.5-hour sessions per week. All reaching practice will include abduction (gravity) loading standardized to the participant's motor abilities. The experimental group intervention will also include a horizontal viscous resistant element similar to pushing the arm through molasses.
16179728|NCT01548768|Drug|TNF inhibitors|"TNF inhibitors are an FDA approved class of medications indicated for the treatment of RA when initial treatment (usually with methotrexate) has failed to achieve remission of RA disease activity. TNF inhibitors are part of the standard of care management of RA.
~The possible TNF inhibitors are: Remicade, Humira, Enbrel, Cimzia, Simponi."
16179729|NCT01548768|Drug|DMARDs|Standard of care treatment for RA, such as Methotrexate or other disease-modifying antirheumatic drugs.
16179730|NCT01548742|Behavioral|Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR) is a group based treatment focused on progressive training in mindfulness meditation.
16179731|NCT01548742|Behavioral|Present-Centered Group Therapy (PCGT)|Present-Centered Group Therapy (PCGT) is a group therapy focused on current problems.
16179732|NCT01548729|Procedure|Combined pancreatic islet and lung transplantation|Combined pancreatic islet and lung transplant from the same donor for the treatment of patients with end-stage cystic fibrosis
16179733|NCT01548703|Drug|BCI-838|BCI-838 100 mg or matching placebo administered once daily for 7 days
16179734|NCT01548703|Drug|BCI-838|BCI-838 or matching placebo administered once daily for 7 days; the dose of BCI-838 will be determined based on the safety and PK data from the preceding dosing arm.
16179735|NCT01548703|Drug|BCI-838|BCI-838 or matching placebo administered once daily for 7 days; the dose of BCI-838 will be determined based on the safety and PK data from the preceding dosing arm.
16179736|NCT01548690|Drug|Ornithine Phenylacetate|"Up to 36 patients will be enrolled into 2 groups [~18 with minimal renal dysfunction (Cohort 1) & ~18 w/ comprised renal function (Cohort 2)] and receive OCR-002 infusion for at least 72 hrs. OCR-002 will be administered in the vein and pharmacokinetics (pk) assessed for all subjects who receive the infusion.
~The first 24 enrolled subjects received OCR-002 at 3 ascending dose levels (DLs 1-3) with a maximum target infusion rate equivalent to 10g/24h.
~The remaining 12 patients (~6 Cohort 1 & ~6 Cohort 2) will be enrolled and receive identical quantities of OCR-002 at 20g/24hr continuously for 5 days (Dose Level 4)."
16179737|NCT01548677|Drug|trastuzumab|8 mg/kg of loading dose IV over 90 minutes for the first cycle, followed by 6 mg/kg IV over 60 minutes every 3 weeks for the 5 subsequent cycles.
16179738|NCT01548664|Other|Wii Fit|15 minutes of gaming activity on the Wii Fit™ following each regularly scheduled 60 minute physiotherapy session, in a separate treatment area.
16179739|NCT01548664|Other|Lower Extremity Exercise|Fifteen minutes of lower extremity exercise that addressed balance, posture, weight shifting and strengthening provided bilaterally following each regularly scheduled 60 minute physiotherapy session, in a separate treatment area.
16179740|NCT01548651|Drug|Saxagliptin|Subjects will be randomized to receive either Saxagliptin 5mg daily orally or placebo for 6 months. All subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma levels of inflammatory markers and C Reactive Protein (CRP), Intracellular Adhesion Molecule (ICAM), vascular cell adhesion molecule (VCAM), plasma lipids, and glucose tolerance (75 gram oral glucose tolerance test) as well as measurement of liver and myocardial fat content and left ventricular systolic and diastolic function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, inflammatory markers and adipocytokines, oral glucose tolerance test, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 months.
16179741|NCT01548651|Drug|Placebo|Subjects will be randomized to receive either Saxagliptin 5mg daily orally or placebo for 6 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, free fatty acids, plasma adipocytokines, plasma levels of inflammatory markers and CRP, ICAM, VCAM, plasma lipids, and glucose tolerance (75 gram oral glucose tolerance test) as well as measurement of liver and myocardial fat content and left ventricular systolic and diastolic function with magnetic resonance imaging/spectroscopy. All subjects will also undergo measurements of monocyte inflammatory proteins at baseline. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, inflammatory markers and adipocytokines, oral glucose tolerance test, monocyte inflammation, as well as hepatic/myocardial fat content determination and left ventricular function at the end of the 6 month treatment period.
16179742|NCT01548638|Drug|Galantamine ER|"The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.
~Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER."
16179743|NCT01548612|Drug|Sodium nitroprusside|Intravenous infusion of 0,5 mcg/kg/min for 240 minutes
16179744|NCT01548612|Drug|Glucose solution|Intravenous infusion of glucose solution 5% for 240 minutes
16179745|NCT01548599|Other|Multi-sectoral agricultural intervention|Participants in the intervention arm will receive a micro-finance loan and training on financial management and marketing skills. With the loan, each participant will receive vouchers to purchase the following items: the Money Maker hip pump, 50 feet of hosing, fertilizer, and government certified seeds. Participants in the intervention group will also receive training on the use of the Money Maker hip pump, a portable, low-cost, human-powered water pump developed by KickStart. Participants in the intervention group will also receive training from Kickstart on the use of the pump as well as complementary training in best horticultural practices.
16179746|NCT01548586|Device|Eldith DC stimulator ( Magstim Company Ltd. UK)|Anodal tDCS: Intensity of 2 mA , during 10 min Cathodal tDCS: Intensity of 2 mA , during 10 min Placebo type tDCS: Intensity of 0 mA during 10 min
16179747|NCT01548573|Drug|Dexamethasone|Given PO
16179748|NCT01548573|Procedure|Tandem autologous stem cell transplant|
16179749|NCT01548573|Drug|Cisplatin|Given IV
16179750|NCT01548573|Drug|Doxorubicin|Given IV
16179751|NCT01548573|Drug|Cyclophosphamide|Given IV or PO
16179752|NCT01548573|Drug|Etoposide|Given IV
16179753|NCT01548573|Drug|Bortezomib|Given IV
16179754|NCT01548573|Drug|Thalidomide|Given PO
16179755|NCT01548573|Drug|Melphalan|Given IV
16179756|NCT01548560|Drug|Dapivirine Vaginal Film|Dosage form: vaginal film Dosage: 1.25mg Frequency: 7 daily doses
16179757|NCT01548560|Drug|Dapivirine Vaginal Gel|Dosage form: vaginal gel Dosage: 0.5%, 2.5g Frequency: 7 daily doses
16179758|NCT01548547|Other|Simulation-based mastery learning|Hands-on coached deliberate practice on a simulator. Training until mastery achieved.
16179759|NCT01548534|Dietary Supplement|Dietary supplementation with fish oil.|Patients randomized in this arm will take 3 cans/day with fish oil : DHA is 1.56 g/d and EPA is 2.64 g/d.
16179760|NCT01548534|Dietary Supplement|Dietary supplementation with vegetable oil|Patients randomized in this arm will take 3 cans/day with vegetable oil : no DHA no EPA.
16179761|NCT01548521|Drug|Oxytocin|2 ui intranasal administration for the 3 first patients, 4UI for the 3 following patients.
16179762|NCT01548508|Other|Functionnal ElectroStimulation (FES)|Functionnal ElectroStimulation on lower limbs, 1h per day, 5 days per 7, during 6 weeks
16179763|NCT01548508|Other|SHAM|SHAM on lower limbs, 1h per day, 5 days per 7, during 6 weeks
16179764|NCT01548482|Other|Laboratory Biomarker Analysis|Correlative studies
16179765|NCT01548482|Other|Pharmacological Study|Correlative studies
16179766|NCT01548482|Drug|Temsirolimus|Given IV
16179767|NCT01548482|Biological|Trebananib|Given IV
16179768|NCT01548469|Other|Bio Mineral toothpaste|Frequency: 2 times everyday/Duration: 4 weeks/Dosage: 1ml at once
16179769|NCT01548469|Other|Perio Total Care toothpaste|Frequency: 2 times everyday/Duration: 4 weeks/Dosage: 1ml at once
16179770|NCT01548456|Procedure|Intramedullary Nailing|Surgical treatment that includes closed or open reduction and stabilization of the femur fracture with an intramedullary rod inserted using antegrade or retrograde technique
16179771|NCT01548456|Procedure|Open Reduction Internal Fixation|Surgical treatment that includes open reduction internal fixation of the femur fracture with a dynamic compression plate
16179772|NCT01548443|Device|Medifoam H dressing|"Cover medifoam H on the wound for a week."
16179773|NCT01548443|Device|Duoderm THIN dressing|"Cover Duoderm THIN on the wound for a week"
16179774|NCT01548430|Drug|TTP4000|
16179775|NCT01548430|Drug|Placebo|
16179776|NCT01548417|Drug|Korlym (mifepristone)|600 mg/day, oral pill, 7 days
16179777|NCT01548417|Drug|Sugar Pill|600 mg/day, oral pill, 7 days
16179778|NCT01548404|Drug|Placebo|Subcutaneous injection altered between back of arms, abdomen and upper thighs.
16179779|NCT01548404|Drug|Dupilumab|Subcutaneous injection altered between back of arms, abdomen and upper thighs.
16179780|NCT01548391|Drug|HX-1171|20mg, 200mg, 500mg
16179781|NCT01548378|Genetic|NL003|Day 0: 8mg of NL003 (32 injections of 0.5ml of NL003) Day 14: 8mg of NL003 (32 injections of 0.5ml of NL003) Day 28: 8mg of NL003 (32 injections of 0.5ml of NL003)
16179782|NCT01548378|Genetic|NL003|Day 0: 6mg of NL003 (24 injections of 0.5ml of NL003) and 4ml normal saline(8 injections) Day 14: 6mg of NL003 (24 injections of 0.5ml of NL003) and 4ml normal saline(8 injections) Day 28: 6mg of NL003 (24 injections of 0.5ml of NL003) and 4ml normal saline(8 injections)
16179783|NCT01548378|Genetic|NL003|Day 0: 4mg of NL003 (16 injections of 0.5ml of NL003) and 8ml normal saline(16 injections) Day 14: 4mg of NL003 (16 injections of 0.5ml of NL003) and 8ml normal saline(16 injections) Day 28: 4mg of NL003 (16 injections of 0.5ml of NL003) and 8ml normal saline(16 injections)
16179784|NCT01548378|Other|Normal Saline|Day 0: 16ml of Normal Saline (32 injections ) Day 14: 16ml of Normal Saline (32 injections ) Day 28: 16ml of Normal Saline (32 injections )
16179785|NCT01548365|Other|Infusion therapy nursing expert service|"The ITNE will assess the patient and treatment characteristics and use an evidence based decision making algorithm for the selection of the most suitable VAD.
~If the VAD needed is a PICC or a midline ITNE will place it following hospital's protocols. If needed, ITNE will also educate and support patients and next of keens in the maintenance of the device at home.
~If other devices such as peripheral catheters, central venous catheters (jugular or subclavian) or venous subcutaneous reservoirs are the preferable VADs for patients and treatment conditions, ITNE will work together with health professionals in charge of patients to activate the usual procedures to place the according device."
16179786|NCT01548339|Procedure|Laparoscopic cholecystectomy|3 trocars laparoscopic cholecystectomy
16179787|NCT01548326|Drug|Atorvastatin|one 40 mg Atorvastatin tablet orally per day for 10 days
16179788|NCT01548326|Drug|placebo|one Placebo tablet orally per day for 10 days
16179789|NCT01548287|Drug|AZD5213|AZD5213 doseA daily
16179790|NCT01548287|Drug|AZD5213|AZD5213 doseB daily
16179791|NCT01548287|Drug|AZD5213|AZD5213 doseC daily
16179792|NCT01548287|Other|Placebo|Placebo tablet daily
16179793|NCT01548274|Drug|Sarpogrelate|Sarpogrelate 300mg/day
16179794|NCT01548261|Procedure|Donating oral mucosal cells|Donating oral mucosal cells
16179866|NCT01547559|Drug|part1:EAC-T|esomeprazole 20 mg, amoxicillin 1 g, and clarithromycin 500 mg, each twice daily followed by gastric mucosal protective therapy with teprenone 50mg three times daily for 11 weeks
16179795|NCT01548248|Drug|insulin detemir|Prescribed insulin detemir and insulin aspart based on the clinical judgement of the physician. The insulin preparations were prescribed by the physician solely as a result of a normal clinical evaluation. The physician determined the starting dose and frequency, as well as later changes to either dose or frequency, if any.
16179796|NCT01548248|Drug|insulin aspart|Prescribed insulin detemir and insulin aspart based on the clinical judgement of the physician. The insulin preparations were prescribed by the physician solely as a result of a normal clinical evaluation. The physician determined the starting dose and frequency, as well as later changes to either dose or frequency, if any.
16179797|NCT01548235|Drug|biphasic insulin aspart 30|Prescribed biphasic insulin aspart 30 as part of routine care. Starting dose, dose titration and injection frequency determined individually by each physician.
16179798|NCT01548209|Drug|Dexmedetomidine|A single dose dexmedetomidine 0.5 mcg/kg IV. 30 min before end of the surgery
16179799|NCT01548209|Drug|Placebo|Placebo 0.5 mcg/kg iv. 30 min before end of the surgery
16179800|NCT01548196|Procedure|Standard Percutaneous nephrolithotomy|Percutaneous nephrolithotomy
16179801|NCT01548183|Behavioral|Lifestyle counseling|Weekly SMS assessments of risky sexual encounters with feedback
16179802|NCT01548170|Drug|Sunitinib|One capsule of sunitinib 50 mg orally. Single dose
16179803|NCT01548170|Drug|Sunitinib and Ketoconazol|Sunitinib capsule 37.5mg. Single dose Ketoconazol 2 tablets of 200mg administered daily during 6 days.
16179804|NCT01548170|Drug|Sunitiinb and Ketoconazol|Sunitinib capsule 37.5mg. Single dose Ketoconazol 1 tablet of 200mg administered daily during 6 days.
16179805|NCT01548170|Drug|Sunitinib and Ketoconazol|Sunitinib capsule 25mg. Single dose Ketoconazol 1 tablet of 200mg administered daily during 6 days.
16179806|NCT01548170|Drug|Sunitinib and Ketoconazol|Sunitinib capsule 25mg. Single dose Ketoconazol 2 tablets of 200mg administered daily during 6 days.
16179807|NCT01548157|Drug|HCP1007 / omarco and crestor|HCP1007 / Rosuvastatin plus Omega-3
16179808|NCT01548144|Drug|Crizotinib (Xalkori)|"Starting dose for Crizotinib - Groups A, B, C: 250 mg by mouth every other day, 1 or 2 times a day on Day 1 of a 21 day cycle. Participant told how often to take this drug.
~Expansion Groups Starting Dose: MTD from Phase 1."
16179809|NCT01548144|Drug|Pazopanib|"Starting Dose for Pazopanib - Groups A, C, D: 200 mg by mouth daily in a 21 day cycle.
~Expansion Groups Starting Dose: MTD from Phase 1."
16179810|NCT01548144|Drug|Pemetrexed|"Starting dose for Pemetrexed - Groups B + C: 200 mg/m2 by vein on Day 1 of a 21 day cycle.
~Expansion Groups Starting Dose: MTD from Phase 1.
~Starting dose for Pemetrexed Group D: 400 mg/m2 by vein every 3 weeks on Day 1 of a 21 day cycle.
~Expansion Group Starting Dose: MTD from Phase 1."
16179811|NCT01548131|Behavioral|Psychoeducative group therapy|6 sessions during pregnancy and 1 after childbirth
16179812|NCT01548118|Biological|HPV 16/18 vaccine, 0,5ml|Subjects were planned to receive HPV vaccine 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
16179813|NCT01548118|Biological|Placebo control, 0.5ml|Subjects were planned to receive three doses of the placebo control 0.5ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule.
16179814|NCT01548118|Biological|HPV 16/18 vaccine, 1.0ml|Subjects were planned to receive HPV vaccine 1.0ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule
16179815|NCT01548118|Biological|Placebo control, 1.0ml|Subjects were planned to receive three doses of the placebo control 1.0ml administered intramuscularly according to a 0, 2, 6 month vaccination schedule.
16179816|NCT01548105|Other|Blood draw for the study participants|"These will include:
~Procollagen 1-N propeptide levels (PINP)
~Matrix metalloproteinase (MMP9)
~Plasma Vitamin C levels"
16179817|NCT01548092|Drug|Adipose-derived stem cells without expanded|Administration will be intralesional injection of cells suspension. They will be placed into fistula walls
16179818|NCT01548079|Drug|Ursodeoxycholic Acid (UDCA)|20mg/kg/day UDCA in three weeks
16179819|NCT01548066|Drug|Valproic Acid|spray 7.2% of sodium valproate on scalp twice a day (morning and evening) for 24 weeks
16179820|NCT01548066|Drug|Control placebo|spray vehicle without sodium valproate on scalp twice a day (morning and evening) for 24 weeks
16179821|NCT01548053|Other|PC-DATA tool|The implementation plan consists of educational sessions and a dementia care manager (DCM). The educational sessions consist of two components: a 1.5 hour group-based DATA tool implementation workshop with primary care providers (PCPs); and, a 1 hour follow-up session at study mid-point. The DCM will facilitate application of the DATA tool and provide direct support to PCPs during the study.
16179822|NCT01548040|Device|Kneehab XP|NMES using Kneehab XP on the affected leg,20 minutes, twice per day, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively
16179823|NCT01548040|Device|Quadriceps TENS|on the affected leg, 20 minutes, twice per days, 5 days a week. Subjects will begin use of the device at 6 weeks pre-operatively and continue through 6 weeks post-operatively.
16179824|NCT01548027|Procedure|Local infiltration group|patients would have 0.5 ml/kg of 0.25% bupivacaine if age < 6 months or 1 ml/kg if age > 6 months around the wound by surgeon. The needle will be injected in subcutaneous tissue parallel to the wound.
16179825|NCT01548027|Procedure|TAP block|Surgical TAP block (sTAP: Patients would have 0.5 ml/kg of 0.25% bupivacaine if age < 6 months or 1 ml/kg if age > 6 months
16179826|NCT01548027|Other|No intervention|No intervention
16179827|NCT01548014|Dietary Supplement|VSL#3|children with severe Crohn's disease were assigned in a 1:1 ratio with either IFX 5 mg/kg q 12 weeks + concurrent immunomodulator + VSL#3 (4 sachets of 450 x 109 organisms per day) (Group A), or IFX 5 mg/kg q 8 weeks + concurrent immunomodulator (Group B).
16179828|NCT01548001|Drug|Iguratimod|25 mg/tablet, taken orally, 2 tablets/day (bid)
16179829|NCT01548001|Drug|Methotrexate|2.5 mg/tablet, taken orally once a week, 4 tablets/week (week 1-week 4) , 6 tablets/week (week 5- week 52)
16179867|NCT01547559|Drug|part1:EA-EMC-T|esomeprazole 20 mg plus amoxicillin 1 g, twice daily for 5 days, then esomeprazole 20 mg with clarithromycin 500 mg and metronidazole 500 mg, twice daily for another 5 consecutive days) followed by teprenone 50mg three times daily until 12 weeks
16179868|NCT01547559|Drug|part1:teprenone|Teprenone 50mg tid after meal for Hp positive patients.
16179869|NCT01547559|Drug|part2:GGA group|GGA 50mg three times daily plus diclofenac sodium 75mg once a day for patients with rheumatic diseases.
16179870|NCT01547546|Drug|GDC-0084|Multiple doses
16179830|NCT01547988|Other|Balance Training Intervention|The intervention group participated in a total of 24 one-hour training sessions over a period of 12 weeks. The training program utilized different size balls as a general tool in a series of progressively more difficult exercises targeting sitting, standing, and gait-related balance control. The program included exercises at five different levels of progressively more challenging balance exercises. Levels 1-4 focused on voluntarily controlled balance exercises, whereas level 5 also included perturbation exercises to trigger automatic compensatory stepping responses. All levels included attention-demanding dual task exercises that required subjects to simultaneously perform motor and cognitive activities.
16179831|NCT01547962|Device|Gintuit|"Gintuit is prepared in a S fold and trimmed to fit the prepared wound bed, with a standardized width of 5 mm and sutured in place with a 5/0 gut suture."
16179832|NCT01547962|Other|autologous Free Gingival Graft (FGG)|Autologous FGG harvested from the subject's palate, the width of the FGG will be 5 mm and sutured in place with a 5/0 gut suture.
16179833|NCT01547949|Dietary Supplement|tart cultivar Montmorency cherry juice|
16179834|NCT01547949|Dietary Supplement|placebo cherry fruit drink|
16179835|NCT01547923|Genetic|Blood sample for phenotypic and pharmacogenetic analysis.|Prior to treatment by 5-FU, a DPD deficiency is identified thanks to just one blood sample (lithium heparinate).
16179836|NCT01547923|Genetic|Blood sample for phenotypic and pharmacogenetic analysis.|Blood sample (lithium heparinate) will be taken prior to treatment but not analysed.
16179837|NCT01547910|Dietary Supplement|Fish Oil|Fish oil given in supplementary dose
16179838|NCT01547897|Drug|NOX-E36|0.5 mg/kg study drug or placebo as SC injections twice a week
16179839|NCT01547806|Drug|Filgrastim|Filgrastim will be administered as a single daily dose in a dose range of 10-16ug/kg/day subcutaneously for 5-7days
16179840|NCT01547806|Drug|Plerixafor|Plerixafor will be given on day 4, 8-10 hours before the day 5 apheresis, dose calculated according to patient weight
16179841|NCT01547806|Procedure|Apheresis|The minimum cluster of differentiation 34 (CD34)+ cell dose that must be collected in order to proceed with a single autologous transplantation is 2 x 106 CD34+ cells/kg.
16179842|NCT01547780|Drug|[11C]PBR28 and Positron Emission Tomography (PET)|Brain PET with [11C]PBR28. 11C]PBR28 is a new PET ligand that images TSPO with high levels of specific binding.
16179843|NCT01547741|Drug|Doxorubicin|
16179844|NCT01547741|Drug|Cyclophosphamide|
16179845|NCT01547741|Drug|Docetaxel|
16179846|NCT01547741|Drug|Paclitaxel|
16179847|NCT01547728|Drug|Recombinant antithrombin (rhAT)|Subjects will receive an intravenous bolus of 500 units of recombinant, human antithrombin (rhAT, ATRYN ®). If the subject remains heparin-resistant, one more IV bolus of 500 units rhAT is given.
16179848|NCT01547715|Biological|Meningococcal ACWY conjugate vaccine|All subjects received a single dose of Meningococcal ACWY conjugate vaccine
16179849|NCT01547702|Behavioral|Teacher Help for ADHD|"Teachers will review powerpoints other materials online and will have access to a study coach to assist with their understanding and practical application of the materials. Session descriptions follow:
~Session 1: Provide information about ADHD characteristics, impact, diagnosis, etiology
~Session 2: Help establish teacher's role; goal setting; introduce behaviour planning
~Session 3: Help develop and implement behaviour program specific to the needs of students with Session 2 goals
~Session 4: Help develop strategies re: classroom structure, work assignments, teacher-student relationship
~Session 5: Help to use instructional interventions for ADHD
~Session 6: Help to teach these students self-monitoring and self-evaluation skills; help teachers to evaluate progress, phase out behaviour program, and plan for relapses in unwanted behaviours"
16179850|NCT01547689|Biological|Human Umbilical Cord Derived MSC|20 million cells per subject（0.5×10^6 UC-MSCs per kg ） intravenous injection Infusion number:8 (Once every two weeks in the first month of each quarter) Time interval: two and a half months
16179851|NCT01547676|Procedure|robot-assisted laparoscopic surgery|Unclamped partial nephrectomy
16179852|NCT01547676|Procedure|robot-assisted laparoscopic surgery|Undergo clamped partial nephrectomy
16179853|NCT01547650|Other|Calculated CVP by using cardiac echogram|Before and after the correction of plasma volume
16179854|NCT01547637|Procedure|Obturator nerve block|Peripheral obturator nerve block using 10 ml of 2% lidocaine
16179855|NCT01547637|Procedure|Obturator nerve block|Ultrasound guided peripheral obturator nerve block
16179856|NCT01547624|Other|Neck specific exercises|Neck specific exercises 2 times/week for 3 month at a physiotherapist. Home exercises.
16179857|NCT01547611|Other|Customary treatment|The staff at the Neurosurgical clinic will give the patient ordinary pre- and postoperative information. The physiotherapist at the Neurosurgical clinic informs the patients what to avoid the first weeks after surgery and the importance of a good posture and ergonomic thinking in daily life. The patient is also instructed how to do exercises for the shoulder range of motion. Patients have ordinary post-surgery visit to the surgeon and to the physiotherapist about 6 weeks after the surgery, where physiotherapist instructs the patient in exercises for active neck range of motion.
16179858|NCT01547611|Other|Structured behavioural medicine program|The behavioural medicine program includes functional behavioural analysis of the problem, medical exercise therapy, strategies to increase self-efficacy in activities and problem-solving strategies for coping with disability.
16179859|NCT01547598|Drug|travoprost ophthalmic solution 0.004%|Travatan® Z (travoprost ophthalmic solution 0.004%) administered as 1 drop in the affected eye(s) once a day for 4 weeks.
16179860|NCT01547598|Drug|travoprost 0.004% / timolol 0.5% combination ophthalmic solution|DuoTrav® (travoprost 0.004% / timolol 0.5% combination ophthalmic solution) administered as 1 drop in the affected eye(s) once daily in the morning for 12 weeks.
16179861|NCT01547598|Drug|Bimatoprost ophthalmic solution 0.01%|LUMIGAN® RC (bimatoprost ophthalmic solution 0.01%) administered as 1 drop in the affected eye(s) once daily in the evening for 12 weeks.
16179862|NCT01547585|Other|Standardized soy containing muffin|Standardized muffin containing two levels of soy
16179863|NCT01547572|Procedure|The study group will get a video and leaflet on enhanced recovery|The study group will get a video and leaflet
16179864|NCT01547572|Procedure|The control group will receive a leaflet only|The control group will receive a leaflet only
16179865|NCT01547559|Drug|part1:teprenone|Teprenone 50mg tid after meal for Hp negative patients.
16179871|NCT01547520|Drug|Meperidine|intramuscular, 25 mg, 5 to 10 minutes before EGD
16179876|NCT01547468|Procedure|Femoral Nerve Catheterization|A femoral nerve catheter will be placed prior to surgery in this group.
16179877|NCT01547468|Procedure|Intravenous Opioids|Intravenous opioids will be given after surgery to provide pain relief to subjects assigned to this group.
16179878|NCT01547455|Drug|Atorvastatin(Lipitor)|participants take 80mg Atorvastatin orally 12h before surgery with another 40mg 2h before surgery
16179879|NCT01547455|Drug|Placebo|Participants randomized to Control arm take 80mg placebo 12h before surgery with another 40mg 2h before surgery
16179880|NCT01547442|Device|Artisan Aphakia Intraocular Lens|Implantation of an intraocular lens
16179881|NCT01547429|Device|Artisan Aphakia Intraocular Lens|Implantation of lens to correct refractive error in aphakic eye
16179882|NCT01547416|Drug|epidural 250mL of 0.2% ropivacaine and 2 μg/mL of fentanyl, 5 mL/hr continuous infusion and 0.5 mL bolus dose|"Before the induction of anesthesia, epidural catheter was inserted in group GE at T8/9, T9/10, or T10/11 interspinous space with a 17-gauge Tuohy needle in lateral decubitus position and advanced 5 cm cephalad. .
~Epidural analgesia was maintained using the patient-controlled analgesia technique containing 250 mL of 0.2% ropivacaine and 2 μg/mL fentanyl with setting of 5 mL/hr for continuous infusion and 0.5 mL of bolus dose. Lockout time was set to 15 min.
~General anesthesia was induced with 2 mg/kg of propofol and 50 mg of rocuronium. After tracheal intubation, anesthesia was maintained with sevoflurane. All the patients were ventilated with controlled mode of 8 mL/kg of ideal body weight and respiratory rate was adjusted to maintain end-tidal carbon dioxide between 35-40 mmHg."
16179883|NCT01547416|Drug|no epidural drug administered|"Patients allocated to general anesthesia group and DID NOT receive epidural anesthesia.
~General anesthesia was induced with 2 mg/kg of propofol and 50 mg of rocuronium. After tracheal intubation, anesthesia was maintained with sevoflurane. All the patients were ventilated with controlled mode of 8 mL/kg of ideal body weight and respiratory rate was adjusted to maintain end-tidal carbon dioxide between 35-40 mmHg."
16179884|NCT01547390|Drug|Aspirin|
16179885|NCT01547390|Drug|placebo|
16179886|NCT01547377|Dietary Supplement|zinc and selenium supplementation|Data from patients were obtained at beginning and after four months of treatment with 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation or placebo. The anthropometric and dietary data, zinc and selenium concentrations in plasma and erythrocyte, lipid profile, electronegative LDL (LDL(-)), anti- electronegative LDL, Ac-LDL(-) immune complexes, GPx and SOD activities, IL-6 and hs-CRP were evaluated in all patients
16179887|NCT01547377|Other|rosuvastatin + placebo|Data from patients were obtained at beginning and after four months of treatment with 10 mg rosuvastatin, concomitantly with zinc (30mg/d) and selenium (150μg/d) supplementation or placebo. The anthropometric and dietary data, zinc and selenium concentrations in plasma and erythrocyte, lipid profile, electronegative LDL (LDL(-)), anti- electronegative LDL, Ac-LDL(-) immune complexes, GPx and SOD activities, IL-6 and hs-CRP were evaluated in all patients
16179888|NCT01547364|Drug|Saline|Injection of 10 ml of normal saline into the caudal epidural space
16179889|NCT01547364|Drug|Dextrose|Injection of 10 ml or dextrose 5% in water into the caudal epidural space
16179890|NCT01547351|Other|ARMS Questionnaire|The ARMS Questionnaire is a 2-part, 2-page survey, with each part comprising 7 questions on 1 page. Eligible patients will be administered part 1 of the survey when the patient presents with new relapse. Part 2 of the survey is to be completed 1 month (± 1 week) after initiation of treatment for relapse.
16179891|NCT01547325|Drug|NanoDOX 1% doxycycline monohydrate Hydrogel|1% doxycycline monohydrate hydrogel
16179892|NCT01547325|Drug|placebo hydrogel|placebo hydrogel
16179893|NCT01547312|Drug|Peg-Interferon|Polyethyleneglycolated Interferon alfa-2b at 1.5 ug/kg/week, administered subcutaneously, once a week, over the entire course of the study.
16179894|NCT01547312|Procedure|Liver Samples from FNA|Tissue samples are collected at 3 separate visits, with each collection consisting of 3-4 fine needle aspiration (FNA) passes through the liver, guided by ultrasound.
16179895|NCT01547312|Procedure|Liver Samples from CNB|Tissue samples are collected at 1 of six possible visits by core needle biopsy (CNB) of the liver.
16179896|NCT01547312|Procedure|Blood Samples|Blood is collected from multiple blood draws, with the total volume for each participant not expected to exceed 500 ml.
16179897|NCT01547312|Drug|Ribavirin|Ribavirin, 600-1400 mg administered orally, twice daily, over the entire course of the study.
16179898|NCT01547312|Drug|800 mg Grazoprevir|800 mg Grazoprevir administered orally, once per day, for 7 consecutive days.
16179899|NCT01547312|Drug|100 mg Grazoprevir|100 mg Grazoprevir administered orally, once per day, for 7 consecutive days.
16179900|NCT01547312|Procedure|Liver samples from CNB and FNA|Tissue samples from the liver are collected by CNB as part of standard of care, and also by FNA during a single visit.
16179901|NCT01547299|Drug|Enzalutamide|
16179902|NCT01547299|Drug|Leuprolide|
16179903|NCT01547299|Drug|Dutasteride|
16179904|NCT01547286|Biological|Standardized Cat Allergen Extract and Standardized Dust Mite Allergen|The route of administration will be topical application of the titrated allergen via nebulized droplets to the lungs. The starting dose of allergen will be 3 dose dilutions below the estimated provocative concentration of allergen that causes a 20% fall in Forced Expired Volume in 1 second delivered for 5 minutes at tidal breathing, followed by Forced Expired Volume in 1 second at 10-minute intervals until the lowest Forced Expired Volume in 1 second is established. If the percent of Forced Expired Volume in 1 second fall is < 20%, the next concentration is given, until the Forced Expired Volume in 1 second falls ≥ 20 percent. When this happens the Forced Expired Volume in 1 second will be followed at 10, 20, 30, 45, and 60 minutes, then hourly for 7 hours. The early asthmatic response is the maximum percent of Forced Expired Volume in 1 second fall between 0 and 3 hours and the late asthmatic response between 3 and 7 hours post allergen challenge.
16179905|NCT01547286|Radiation|Computed Tomography imaging, functional Positron Emission Tomography imaging|Physiology study using Computed Tomography and Positron Emission Tomography imaging with Nitrogen-13 saline as radiotracer; images obtained during the early and late phases after allergen challenge
16179906|NCT01547286|Drug|Nebulized methacholine inhalation|Standard methacholine challenge performed once to determine the subject's dose that causes a 20% fall in Forced Expired Volume in 1 second from baseline.
16179907|NCT01547273|Procedure|bone graft inside socket only|bone graft inside socket only
16179908|NCT01547273|Procedure|bone graft inside and outside socket|bone graft inside and outside socket
16179910|NCT01547260|Drug|Gemzar|Gemcitabine (Gemzar®), 1000 mg/m2 in 0.9% sodium chloride will be administered as intravenous infusion over 30 minutes, weekly for 3 weeks then rest for 1 week (days 1, 8, 15 of each 28-day cycle).
16179911|NCT01547260|Drug|Revlimid|Lenalidomide capsules will be taken orally in the morning each day on days 1-21 of each 28-day cycle. Phase I; Three subjects will be enrolled into each dose cohort for 15, 20 and 25 mg/day, respectively. Phase II; Lenalidomide at dose determined in Phase I, will be administered orally once daily for 21 days followed by 7 days rest.
16179912|NCT01547247|Device|soft straight distal cap D-201-14304 Olympus attached to the tip of the colonoscope|Colonoscopy with transparent cap attached to the tip of the colonoscope and water immersion during insertion phase and romm air insufflation during colonoscope withdrawal.
16179913|NCT01547247|Procedure|water immersion colonoscopy|Colonoscopy without transparent cap using water immersion during insertion phase and romm air insufflation during colonoscope withdrawal.
16179914|NCT01547221|Drug|clotrimazole|single application of 1%clotrimazole ear drop
16179915|NCT01547221|Drug|3% Boric acid|3% boric acid in 70% alcohol was prepared by phamaceutical department of Khonkaen Hospital
16179916|NCT01547208|Procedure|Immediate radiofrequency ablation of ventricular tachycardia|Radiofrequency ablation of ventricular tachycardia is performed immediately after an appropriate ICD shock
16179917|NCT01547208|Procedure|Radiofrequency ablation of ventricular tachycardia|Radiofrequency ablation of ventricular tachycardia will be performed after an arrhythmic storm occurs
16179918|NCT01547195|Procedure|swim training|"Swimming training will be conducted with the implementation of the freestyle. The training will be held a week with 3 X 50 minutes for a period of 12 weeks.
~Patients will be monitored by a frequency waterproof. When at the beginning of training are carried out five minutes of heating, followed by 40minutos swimming 5 minutes and cooling at the end of training."
16179919|NCT01547195|Procedure|Training walk|"The control group will perform walking exercise outdoors, monitored by a frequency, with the heart rate at anaerobic threshold assessed by cardiopulmonary exercise test.
~The training of walking will last 50 minutes, three times per week for 12 weeks.
~At the beginning of training, there will be a heating time of 5 minutes, followed by LA walk in cooling for 40 minutes and 5 minutes."
16179920|NCT01547182|Behavioral|Caloric restriction|Caloric restriction
16179921|NCT01547182|Behavioral|Aerobic Training|Walking
16179922|NCT01547182|Behavioral|Resistance Training|Lifting weights
16179923|NCT01547169|Drug|Placebo Comparator|saline, taken twice per day for a 3 week duration
16179924|NCT01547169|Drug|insulin detemir|10IU of insulin detemir, administered intranasally twice per day for a 3 week duration
16179925|NCT01547169|Drug|insulin detemir|20IU insulin detemir, administered intranasally twice per day for a 3 week duration
16179926|NCT01547156|Device|Intervention group|
16179927|NCT01547143|Drug|IST and/or alloHCT|"1) Patients will be categorized by their initial serum ferritin level.
~Mild ( ferritin<3,000 μg/L): close observation
~Moderate (ferritin: 3,000-10,000 μg/L):
~Initiation : cyclosporine 3mg/kg p.o.bid + dexamethasone 10mg/m2/d po. or i.v. (D1-3)
~continuation: cyclosporine 3mg/kg p.o. bid (D4-56) + dexamethasone 10mg/m2/d (D4-14), then tapering.
~Severe (ferritin>10,000 μg/L):
~initiation : etoposide 100mg/m2/d i.v. + cyclosporine 2mg/kg i.v. q 12hours + dexamethasone 20mg/m2/d i.v. (D1-3)
~continuation : etoposide 100mg/m2/day weekly (D15-49) + cyclosporine 2mg/kg i.v. q 12 hours? ? po. (D4-56) + dexamethasone 10mg/m2/d (D4-14), 5mg/m2/d (D15-28), 2.5mg/m2/d (D29-42), 1.25mg/m2/d (D43-56), then tapering off.
~2) AlloHCT for refractory or reactivated cases."
16179928|NCT01547130|Drug|Normal (0.9%) saline|A total of 2L solution at lukewarm temperature (37.2-38.8 degrees Centigrade)consumed as bolus intake (8-16 oz in one to two minutes) alternating with yoga exercises.
16179929|NCT01547130|Drug|HalfLytely|A total of 2L solution prepared as per manufacturers instructions and sipped until bowel movements are clear.
16179930|NCT01547117|Radiation|Blood Volume|we will measure the amount of hemoglobin and myoglobin in the body by a procedure called carbon monoxide (CO) rebreathing. One teaspoon of blood is taken before and after a small amount of CO has been absorbed into the bloodstream.
16179931|NCT01547117|Radiation|Total Blood Volume|Using injection of iodinated I-131 tagged human serum albumin nominally 25 micro-Ci of radiation, blood samples are drawn before and 30 minutes after injection.
16179932|NCT01547117|Procedure|Exercise Capacity Test - Bicycle|subjects breath room air through a mouthpiece and exhale the air into a tube that connects to a machine (metabolic cart) that analyzes carbon dioxide and oxygen content, which allows the investigator to calculate the amount of oxygen they are using under resting and exercise conditions.
16179933|NCT01547117|Procedure|Posture Study|Blood pressure and heart rate will be measured while supine and then while standing for up to 30 minutes. Blood will be drawn in each position to measure hormones that regulate blood pressure and blood volume.
16179934|NCT01547104|Drug|Linagliptin|Linagliptin dosed 5 mg as add on therapy to an existing metformin therapy
16179935|NCT01547104|Drug|Glimepiride|Glimepiride 1-4mg (individually dosed) as add on therapy to an existing metformin therapy
16179936|NCT01547091|Biological|Umbilical Cord-Derived Mesenchymal Stem Cells (UC-MSCs)|-The UC-MSCs will be infused intravenously(single dose, 4x10^7 cells).The interval time is 3 months, and the study lasts for 12 months with 4 times infusion.
16179937|NCT01547091|Drug|Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs)|-Patients will be treated by conventional drugs (DMARDS) for alleviating disease.
16179938|NCT01547091|Biological|UC-MSC+DMARDS|The UC-MSCs will be infused intravenously(single dose, 4x10^7 cells).The interval time is 3 months, and the study lasts for 12 months with 4 times infusion.Meanwhile,patients will be treated by conventionally drugs if the disease is still not alleviated.
16179939|NCT01547078|Biological|Lyophilized Plasma|Licensed plasma that has been lyophilized.
16179940|NCT01547078|Biological|Licensed Plasma|Plasma that has been authorized for transfusion.
16179941|NCT01547052|Behavioral|DBT for children|intervention consists of weekly individual 45 min. sessions, twice per week 60 min. group sessions, and every other week 90 min. sessions with parents
16179942|NCT01547052|Behavioral|Enhanced Supportive-Educational therapy|weekly individual 45 min sessions, twice per week 60 min. group sessions and every other week parent sessions.
16179943|NCT01547026|Behavioral|Implementation Intentions|In a 10 minute structured therapy session patients are assisted to build up implementation intentions to participate in the sports program.
16179945|NCT01547000|Drug|extended-release guanfacine (Intuniv)|1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks.
16179946|NCT01546987|Drug|bicalutamide|Given orally
16179947|NCT01546987|Drug|buserelin|Given subcutaneously or intramuscularly
16179948|NCT01546987|Drug|flutamide|Given orally
16179949|NCT01546987|Drug|goserelin acetate|Given subcutaneously or intramuscularly
16179950|NCT01546987|Drug|leuprolide acetate|Given subcutaneously or intramuscularly
16179951|NCT01546987|Drug|orteronel|Given orally
16179952|NCT01546987|Drug|triptorelin|Given subcutaneously or intramuscularly
16179953|NCT01546974|Device|HME filter Twin Star 55, Drager Medical, Germany|
16179954|NCT01546974|Device|Heated humidification|
16179955|NCT01546961|Drug|Chloroquine|"Chloroquine phosphate GPO® (Government Pharmaceutical Organization, Thailand) 250 mg (equivalent to chloroquine base 150 mg).
~Dosing will be at 0, 24, 48 hrs with 10 mg/kg on day 0 and day 1, and 5 mg/kg on day 2."
16179956|NCT01546948|Drug|Methadone|Patients in the methadone group will be administered 0.3 mg/kg of methadone intraoperatively: two-thirds of the dose (6 cc or 0.2 mg/kg of methadone) on induction of anesthesia as a bolus. The remainder of the dose (3 cc or 0.1 mg/kg of methadone) will be administered at approximately 1.5-2 hours before the end of the procedure.
16179957|NCT01546948|Drug|Hydromorphone|Patients in the hydromorphone group will receive 0.03 mg/kg of hydromorphone; two-thirds the dose (6 cc or 0.02 mg/kg) on induction of anesthesia, and the remainder of the hydromorphone (3 cc or 0.01 mg/kg) will be bolused 1.5-2 hours before surgery concludes.
16179958|NCT01546935|Drug|Oseltamivir|The dose of Oseltamivir will be 3 mg/kg 12 hourly for 5 days (seasonal influenza and 2009 H1N1) or 10 days (avian influenza) for children whose renal function is ≥ 30 mls/min/1.73m2.
16179959|NCT01546922|Drug|Hydrocortisone|Patients receive either a low dose HC (0.2-0.3 mg/kg body weight) for 10 weeks followed by 10 weeks of high dose HC (0.4-0.6 mg/kg body weight) or vice versa.
16179960|NCT01546909|Biological|Diphtheria, tetanus, polio and pertussis vaccination|1 dose of TETRAVAC-ACELLULAIRE (0.5 mL) at Day 0
16179961|NCT01546896|Drug|buspirone+alprazolam|day 1~7: buspirone 10mg/d + alprazolam 0.5mg / day 8~28: buspirone 20mg/d + alprazolam 0.5mg / day 29~56: buspirone 20~30mg/d + alprazolam 0.5mg
16179962|NCT01546896|Drug|alprazolam|0.5mg/d
16179963|NCT01546883|Drug|Dabigatran etexilate (Pradaxa)|150mg bid or 75mg bid for a period of one year
16179964|NCT01546857|Drug|Placebo|Normal Saline
16179965|NCT01546857|Drug|Gapabentin|400mg orally at 9pm day of surgery and the first evening post operatively.
16179966|NCT01546844|Other|Participation in Care4Life|Text message service to aid patients with self-management of type II Diabetes Mellitus. Includes online access to patient data and management of health goals.
16179967|NCT01546818|Biological|SAV001-H|A whole-killed HIV
16179968|NCT01546805|Drug|Zinc Supplement|The interventional group will be requested to take zinc supplements (50mg), once daily starting 5 days prior to Botox injections and to be continued for 5 days after injection.
16179969|NCT01546805|Drug|Sugar pill|The control group will be requested to take placebo pills, once daily starting 5 days prior to Botox injections and to be continued for 5 days after injection.
16179970|NCT01546792|Behavioral|Combined lifestyle intervention|Exercise training, dietary advice, behaviour change counselling
16179971|NCT01546779|Device|Tri-Gym|40 CF patients performed airway clearance using the VISex, by exhaling against chosen resistance being motivated by visual feedback of raising colored balls. The level of resistance was set to cause longest expiration/volume, until mucus was transported from the peripheral to the central airways, to be expectorated by the subsequent cough.
16179972|NCT01546766|Device|Pupillometry testing.|
16179973|NCT01546753|Drug|Walnut Protein Powder|Dosing begins with a one-day walnut oral desensitization protocol. Starting at 0.1 mg protein and increasing every thirty minutes until a maximum dose of 6 mg is reached or until allergic symptoms develop. After the initial escalation day, subjects will continue daily dosing with dosing build-every two weeks to a maximum dose of 1500mg walnut protein at 34 weeks. A daily maintenance dose (1500mg or the highest dose reached by 34 weeks) will be given for 4 weeks followed by 5 gram oral food challenges to walnut and the second tree nut (at 38 weeks). Active treatment subjects will continue on maintenance dosing for up to a total of 298 weeks of therapy. Subjects reaching a qualifying specific IgE to walnut and the test tree nut at any early time point will receive a tolerance oral food challenge to the tree nuts on and 4 weeks off therapy. All subjects will have an oral food challenge on and off therapy at 142 weeks and at 298 weeks.
16179974|NCT01546753|Drug|Oat Powder (placebo)|Subjects in the placebo group will undergo the same one-day desensitization protocol as the active treatment group, consuming a maximum dose of 6 mg of oat powder (initial day escalation phase). After the initial escalation day achieving at least 1.5 mg and up to 6 mg of oat powder, the dosing build-up will occur every two weeks through dose 24 (1500mg oat flour) at ~34 weeks. A maintenance dose will be given for 4 weeks followed by a 5 gram protein OFC to walnut and a 5 gram protein OFC to a second tree nut (at ~38 weeks). Placebo subjects that fail the OFC will be crossed over to active treatment beginning with initial escalation day.
16179975|NCT01546727|Behavioral|Behavioral Family Intervention|Three months of weekly treatment delivered via alternating group based clinic visits and individual home visits followed by three months of every other week treatment alternating between clinic and home.
16179976|NCT01546727|Behavioral|Motivational Interviewing|Motivational interviewing will be delivered at the same frequency at the behavioral intervention with 4 in-person visits spaced at the first visit, month 3 and month 5. Phone calls will be conducted weekly during the first 3 months and every other week during months 4 through 6.
16179977|NCT01546701|Drug|Buprenorphine|2 mg sublingual tablet
16179978|NCT01546701|Drug|Morphine|0.1 mg/kg IV morphine
16179979|NCT01546688|Drug|Zonisamide at targeted daily doses of 100-500 mg/day|Each group received 2 doses a day (in the morning and evening) during the Titration Period, once a day (in the evening) or BID during the Maintenance Phase, comprising 25 mg, 50 mg, or 100 mg of ZNS capsules
16179980|NCT01546688|Drug|Placebo administered to match targeted daily doses of 100-500 mg/day|matching placebo
16179981|NCT01546675|Other|Skeletal Stabilization|Upper Limb Prosthetic Socket hypothesized to increase skeletal stabilization
16179982|NCT01546662|Dietary Supplement|E-RH-06|Capsules, 1 capsule/ 2 capsule, twice daily for 12 weeks
16179983|NCT01546662|Dietary Supplement|Placebo|1/ 2 capsules, twice daily for 12 weeks
16179984|NCT01546649|Drug|TAP-144-SR(6M)|
16179985|NCT01546649|Drug|TAP-144-SR(3M)|
16179986|NCT01546636|Other|Hypocapnic group|Patients will be ventilated to an ETCO2 of 30-32 mm Hg.
16179987|NCT01546636|Other|Normocapnic group|Patients will be ventilated to an ETCO2 of 40-42 mm Hg
16179988|NCT01546623|Drug|TAP-144-SR(6M)|
16179989|NCT01546623|Drug|TAP-144-SR(3M)|
16179990|NCT01546610|Other|insoles intervention|EVA insole with arch support and bar retrocapital
16179991|NCT01546610|Other|placebo insole|EVA insole flat
16179992|NCT01546597|Drug|Metformin|"Metformin 500 mg bid on Days 1-5
~Metformin 850 mg bid on Days 6-10
~Metformin 500 mg bid on Days 11-15
~Metformin 850 mg bid on Days 16-20"
16179993|NCT01546597|Drug|Ranolazine|"Ranolazine 1000 mg bid on Days 11-15
~Ranolazine 1000 mg bid on Days 16-20"
16179994|NCT01546571|Biological|POL-103A|POL-103A is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
16179995|NCT01546571|Biological|POL-103A without API|Placebo is administered intradermally, divided into 4 injections (0.2 mL each injection) into the volar surface of forearms and into the anterior upper thighs
16179996|NCT01546558|Drug|Metformin|Metformin 1000 mg bid on Days 1-10
16179997|NCT01546558|Drug|Ranolazine|Ranolazine 500 mg bid on Days 6-10
16179998|NCT01546532|Drug|RLX030|RLX030 as intravenous infusion for 24 hours.
16179999|NCT01546532|Drug|Placebo|Intravenous infusion of Placebo over 24 hours
16180000|NCT01546519|Drug|Vismodegib|oral repeating dose of 150 mg once daily
16180001|NCT01546506|Drug|Gutron® treatment|Midodrine 2.5 mg orally 3 times daily, 5 day-treatment.
16180002|NCT01546493|Radiation|MRI|MRI scan. 3.0 Tesla MRI scans of both hips using Tip(T1-rho) and ultra-short echo time (UTE) sequences.
16180003|NCT01546493|Radiation|qCT|Quantitative computed tomography(QCT) scans using a CT phantom
16180004|NCT01546493|Other|Motion Analysis|3D motion analysis to assess hip function.
16180005|NCT01546493|Radiation|PET-MRI|Positron emission tomography combined with magnetic resonance imaging (PET-MRI) is a technology that will help us examine bone and cartilage at the molecular level.
16180006|NCT01546467|Behavioral|Cognitive remediation|Cognitive remediation including feedback from neurocognitive assessment, psychoeducation about cognitive deficits, 30 hours of computer based drill and practise and strategy coaching based cognitive remediation, 1-3 collaborative meetings with cognitive specialist, participant, therapist and teacher, occupational therapist or other therapist (depending on participants rehabilitation situation) to enhance transfer of skills to daily functioning
16180007|NCT01546454|Drug|Ethinyl Estradiol-Levonorgestrel combination|0.03 mg ethinyl estradiol, 0.15 mg levonorgestrel oral daily for 21 days
16180008|NCT01546454|Drug|leuprolide acetate|single 22.5 mg subcutaneous depot suspension
16180009|NCT01546454|Drug|Estradiol|0.05 to 0.3 mg transdermal daily for 26 days
16180010|NCT01546454|Drug|Progesterone|50 to 100 mg vaginal suppositories twice daily for 13 days
16180011|NCT01546441|Behavioral|interprofessional assessment|assessment by interprofessional team
16180012|NCT01546441|Behavioral|usual care|usual care in primary care clinic
16180013|NCT01546428|Drug|INC280|
16180014|NCT01546415|Drug|Desferasirox|Initial Dose: 20 mg/kg/d. Dose modification according to protocol.
16180015|NCT01546402|Drug|Dexamethasone Drug delivery system (Ozurdex)|It is a sustained release intravitreal implant containing 700µg dexamethasone has been approved by the US-FDA (Food and Drug Administration).
16180016|NCT01546402|Procedure|Cataract surgery|Using a clear corneal incision, continuous curvilinear capsulorhexis, hydrodissection, phacoemulsification and irrigation/aspiration of the cortex will be performed. Foldable intraocular lens will be implanted in the capsular bag. All patients will receive standard postoperative topical steroid (betamethasone 0.1%), antibiotic (moxifloxacin 0.5%) and homatropine (2%) therapy.
16180017|NCT01546389|Biological|Sanaria™ PfSPZ Vaccine|30 subjects in 3 cohorts, 6 groups in different doses of PfSPZ vaccine via the intradermal route. Cohort 1 Medium Dose, Medium Aliquot: Group a: 10,000 PfSPZ in 2 divided doses (e.g., 5000 PfSPZ per 50 microliter (mcL) dose), Group b: 10,000 PfSPZ in 8 divided doses (e.g., 1250 PfSPZ per 50 mcL dose). Cohort 2: Medium dose, Low Aliquot: Group c: 10,000 PfSPZ in 2 divided doses (e.g., 5000 PfSPZ per 10 mcL dose), Group d: 10,000 PfSPZ in 8 divided doses (e.g., 1250 PfSPZ per 10 mcL dose), Cohort 3: High Dose, Low Aliquot; Group e: 50,000 PfSPZ in 2 divided doses (e.g., 25,000 PfSPZ per 10 mcL dose), Group f: 50,000 PfSPZ in 8 divided doses (e.g., 6,250 PfSPZ per 10 mcL dose)
16180018|NCT01546389|Drug|Chloroquine|Rescue therapy after challenge: 1500 mg chloroquine base orally, over 48 hours (600 mg at time 0 followed by 300 mg oral base at hours 6, 24 and 48)
16180019|NCT01546376|Radiation|Radiation therapy|External photon beam radiation therapy dosage 4000-7000 CGy
16180020|NCT01546376|Other|Venepuncture|Venepuncture for CD4 and viral load count at Week 0, Last week of Radiation, and 12, 24 Week follow up
16180021|NCT01546363|Other|Blood draw|phlebotomy
16180022|NCT01546350|Genetic|PGD|array CGH after blastocyst biopsy
16180023|NCT01546350|Procedure|PGD|PGD using blastocyst biopsy and testing of the biopsy by array CGH
16180024|NCT01546324|Procedure|Blood draw|Maternal blood draw at approximately 8-17 weeks gestation.
16180025|NCT01546311|Device|Pro Active Dynamic Accommodating Socket|Socket with bladders that instantaneously adjusts to volume fluctuations in the residual limb
16180026|NCT01546298|Other|Patch tests|Patch tests for allergic reaction
16180027|NCT01546285|Device|Blood Pressure Readings on B40 Patient Monitor|Simultaneous blood pressure reading on the Investigational B40 patient monitor and DINAMAP PRO1000 patient monitor
16180028|NCT01546272|Device|Insorb resorbable staples|Subcutanous suture using resorbable staples
16180029|NCT01546272|Device|Monocryl resorbable wire|Subcutanous suture using resorbable wire
16180066|NCT01546025|Behavioral|Brief Motivational Counseling|One hour session of brief motivational counseling focused on reduction of heavy drinking.
16180067|NCT01546025|Behavioral|Relaxation training|One hour training in relaxation techniques
16180068|NCT01546012|Device|HYABAK®|Hyaluronic Acid eye drops CE marked, packaged in multidose ABAK® container (preservative free)
16187754|NCT01488877|Drug|PF-03882845|up to 10 mg tablet once daily
16180030|NCT01546259|Other|Water colonoscopy|Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope. The water infusion involves putting warm sterile water into the colon to open up the colon for advancement of the colonoscope until the end of the colon (cecum) is reached. The water is delivered through scope irrigation channel by an infusion pump equipped with a foot switch which will be controlled by the endoscopist. Infused water used to cleanse residual fecal matter will be suctioned as needed to clear the colonic lumen.
16180031|NCT01546246|Other|Water colonoscopy|Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope. The water infusion involves putting warm sterile water into the colon to open up the colon for advancement of the colonoscope until the end of the colon (cecum) is reached. The water is delivered through scope irrigation channel by an infusion pump equipped with a foot switch which will be controlled by the endoscopist. Infused water used to cleanse residual fecal matter will be suctioned as needed to clear the colonic lumen.
16180032|NCT01546233|Behavioral|multidisciplinary education programme|Educate of self-care by Oncology nurses to relieve and prevent the fatigue of cancer chemotherapy, and provide the manual to read at home, take about 15 minutes. By using home exercise program, 30 minutes of physical education. Teaching and demonstration exercises of the muscles to breath and conservation of energy during exercise and record the exercise/walking diary, the nutritional education nutrition counseling, psychiatric assessment,self-care prevention of depression.
16180033|NCT01546233|Behavioral|standard education|standard education before and after chemotherapy
16180034|NCT01546220|Other|Water colonoscopy|Colonoscopy will be performed without medications and aided by water infusion in-lieu of air insufflation during insertion of the colonoscope. The water infusion involves putting warm sterile water into the colon to open up the colon for advancement of the colonoscope until the end of the colon (cecum) is reached. The water is delivered through scope irrigation channel by an infusion pump equipped with a foot switch which will be controlled by the endoscopist. Infused water used to cleanse residual fecal matter will be suctioned as needed to clear the colonic lumen.
16180035|NCT01546207|Procedure|catheter-based ablation|specific electrophysiological and mapping techniques of activation and entrainment mapping during ongoing VT. Substrate mapping and ablation (substrate modification.) catheter ablation - a medical procedure used to treat some types of arrhythmia
16180036|NCT01546194|Other|Phone call explaining the research project|A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial
16180037|NCT01546168|Device|esophageal deviation with IDE device|esophageal deviation during AF ablation
16180038|NCT01546155|Radiation|PET imaging|Up to a 120 minute PET scan using [11C]diprenorphine as the radiotracer
16180039|NCT01546142|Drug|Deoxycholic acid injection|Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
16180040|NCT01546142|Drug|Placebo|Phosphate buffered saline placebo for injection
16180041|NCT01546129|Device|Dianatal Obstetric Gel (Cross-linked polyacrylic acid)|Dianatal (approx. 30 mL in total) will be intermittently administered to the birth canal after vaginal examination in labor using the Dianatal applicator or the syringe or the fingers. Dianatal Stage I is used during labor stage I, Dianatal Stage 2 is used during stage 2. After rupture of the membranes supplementary Dianatal is applied within 5 to 20 minutes.
16180042|NCT01546116|Drug|ADEFOVIR, LAMIVUDINE|Adefovir/10mg tablet/once a day/52week Lamivudine/100mg tablet/once a day/52week
16180043|NCT01546103|Dietary Supplement|Cholecalciferol|1000 IU by mouth, once daily for 3 months.
16180044|NCT01546103|Dietary Supplement|Cholecalciferol|5000 IU by mouth, once daily for 3 months.
16180045|NCT01546090|Drug|Alprazolam|preoperative administration of an orally 0.50 mg single dose
16180046|NCT01546090|Drug|placebo|placebo capsules were filled with starch
16180047|NCT01546077|Procedure|Placement of perineural catheters with Hydrolocalization technique using|Placement of perineural catheters in the popliteal region comparing two techniques. while the drugs used are the same (ropivacaine 0.6% for initial bolus and 0.2% for continuous technique) we will compare dosage required in each group
16180048|NCT01546064|Device|Choledocho-choledochostomy with T-tube|In the anastomosis between the common bile duct of the graft and the common bile duct of the recipient, a tutorial T-tube is inserted in the bile duct lumen and will be removed from the patient on third month postoperatively.
16180049|NCT01546064|Device|Choledocho-choledochostomy without T-tube|The termino-terminal anastomosis between common bile duct of the graft and common bile duct of the recipient is performed without any T-tube.
16180050|NCT01546051|Drug|BCI-838|BCI-838 100 mg and 300 mg or matching placebo administered as single oral doses under fasted conditions in a sequential design
16180051|NCT01546051|Drug|BCI-838|BCI-838 administered as a single 30 mg oral dose or matching placebo under fasted and fed conditions in a crossover design
16180052|NCT01546051|Drug|BCI-1038, BCI-1206 & BCI-1283|Three new pro-drugs administered as a 1 mg single oral doses under fasted conditions in a sequential design
16180053|NCT01546051|Drug|BCI-838|BCI-838 900 mg or matching placebo administered as a single oral dose under fasted conditions
16180054|NCT01546038|Drug|PF-04449913|PF-04449913 administered orally and continuously for 28-days.
16180055|NCT01546038|Drug|Low dose ARA-C (LDAC)|Low dose ARA-C (LDAC) administered at 20 mg SQ, BID on Days 1 through 10.
16180056|NCT01546038|Drug|PF-04449913|PF-04449913 administered orally and continuously for 28 days.
16180057|NCT01546038|Drug|Decitabine|Decitabine given at 20 mg/m2 over 1 hour infusion for 5-days
16180058|NCT01546038|Drug|PF-04449913|PF-04449913 administered orally and continuously for 28 days
16180059|NCT01546038|Drug|Daunorubicin|Daunorubicin given using 60 mg/m2 for 3-days
16180060|NCT01546038|Drug|Cytarabine|Cytarabine 100 mg/m2 on days 1 through 7
16180061|NCT01546038|Drug|PF-04449913|PF-04449913 administered orally and continuously for 28 days
16180062|NCT01546038|Drug|Daunorubicin|Daunorubicin given using 60 mg/m2 for 3-days
16180063|NCT01546038|Drug|Cytarabine|Cytarabine 100 mg/m2 on days 1 through 7
16180064|NCT01546038|Drug|PF-04449913|PF-04449913 administered orally and continuously for 28 days (if randomized to receive PF-04449913)
16180065|NCT01546038|Drug|Low dose ARA-C (LDAC)|Low dose ARA-C (LDAC) administered at 20 mg SQ, BID on Days 1 through 10.
16180101|NCT01545700|Drug|Control saline|Patients are randomized to receive saline 2 cc
16180069|NCT01546012|Device|HYLO-COMOD®|Hyaluronic Acid eye drops CE marked, packaged in multidose COMOD® container (preservative free)
16180070|NCT01545999|Other|Brain Stimulation via Transcranial Magnetic Stimulation|"PAS-25 will consist of 180 PNS delivered to right median nerve, each paired with a single TMS pulse delivered over left DLPFC with an interstimulus interval of 25 ms. This ISI was designed to generate approximately synchronous arrival of both inputs in M1 and was reported to markedly enhance TMS-induced MEP following PAS-25.
~Patients with schizophrenia will be asked to continue with a 2-week course (5 days/week) of daily PAS-25 or PAS-100 to assess potential of a repetitive course of PAS-25 on enhancing working memory in patients with Schizophrenia. One and seven days after the 2-week course PAS-25 or PAS-100, patients with schizophrenia will be assessed with the N-back task."
16180071|NCT01545986|Behavioral|Exercise|Participants attended standardized exercise (ex) sessions twice a week for six weeks for 12 sessions. Group speed differed for concentric contractions, sit to stand ex, walking, curbs, and stairs. The low velocity ex group performed a concentric contraction in two seconds, and high velocity group in one second or less. End range concentric hold, eccentric contraction, repetition (rep) rest and set rest were the same. Open chain ex was performed at 50% of one Repetition Maximum (RM) x 10 reps x one set and then 80% of 1RM x 10 reps x two sets. Curb height and 1RM was assessed at the first, fifth and ninth sessions. Manual stretching, balance ex, sit to stand support, level of aerobic ex, gait training, and functional training were assessed and progressed at any session.
16180072|NCT01545973|Other|Skin Moistening, Skin Denuding|Application of normal saline to skin and Tape stripping of the superficial skin
16180073|NCT01545960|Other|not applicable in this study|No actual interventions will be administered for this study.
16180074|NCT01545947|Drug|CC-223, erlotinib|"Dose escalation: Combination doses start with 15 mg CC-223 and 100 mg erlotinib, or 15 mg CC-223 and 150 mg erlotonib, administered in 28-day cycles. Combination dose levels increase sequentially using predefined regimens until non-tolerated dose levels are established and a maximum tolerated dose combination has been identified for further study.
~Dose expansion: The maximum tolerated doses are evaluated further for evidence of preliminary efficacy"
16180075|NCT01545947|Drug|CC-223, oral azacitidine|"Dose escalation: Combination doses start with 15 mg CC-223 and 200 mg oral azacitidine, administered in 28-day cycle. Combination dose levels increase sequentially using predefined regimens until non-tolerated dose levels are established and a maximum tolerated dose combination has been identified for further study.
~Dose expansion: The maximum tolerated doses are evaluated further for evidence of preliminary efficacy"
16180076|NCT01545947|Drug|CC-223, oral azacitidine|"Dose escalation: Sequential dosing starts with 200 mg of oral azacitidine administered on Days 1 through 7 of each 28-day cycle, followed by daily dose level of 15 mg CC-223 on Days 8 through 28. Combination dose levels increase sequentially using predefined regimens until non-tolerated dose levels are established and a maximum tolerated dose combination has been identified for further study.
~Dose expansion: The maximum tolerated doses are evaluated further for evidence of preliminary efficacy"
16180077|NCT01545934|Behavioral|Lifestyle intervention|The intervention is a multicomponent program designed to prevent excessive gestational weight gain in obese women through modifications of diet, exercise, and behavioral strategies during pregnancy.
16180078|NCT01545921|Other|Quality Of Life questionnaires completion|"Before randomization, all patients will have to complete questionnaires in this order : QLQ-C15-PAL, MVQOLI and QUAL-E.
~MVQOLI and QUAL-E will be completed again 3 days after the first completion at baseline. After this second QoL assessment, the order will be modified according to patient's randomisation : arm A, B, C or D."
16180079|NCT01545908|Other|Fecal transplant|Participants in this arm undergo 6 retention enemas,using stool specimen prepared from a healthy, screened unrelated donor.
16180080|NCT01545908|Other|Placebo enema|Patients will receive placebo enema, week 1, week 2, week 3, week 4, week 5, week 6
16180081|NCT01545882|Drug|Degarelix|Treatment will consist of a starting dose of 240mg injected subcutaneously (s.c) and monthly s.c. maintenance doses of 80mg for a total duration of 6 months.
16180082|NCT01545869|Procedure|Fractional carbon dioxide laser|SmartXide fractional carbon dioxide laser (DEKA, Florence, Italy). Parameters adjusted for: Power 20 watts, spacing 200 µsec, dwell time 300 µm, stacks 1.
16180083|NCT01545856|Drug|levodopa|levodopa use
16180084|NCT01545843|Behavioral|Sleep scheduling|8 hours vs. 6 hours time in bed for two weeks, with either 2 hour advance of risetime, or 2 hour delay of bedtime
16180085|NCT01545843|Drug|Fluoxetine|20-40 mg fluoxetine daily for 8 weeks
16180086|NCT01545830|Dietary Supplement|vitamin D3 (cholecalciferol)|Active intervention: 6,000 IUs taken by mouth daily for 6 months Active Comparator: 600 IUs taken by mouth daily for 6 months
16180087|NCT01545817|Drug|Pazopanib followed by everolimus|All patients received Pazopanib (800 mg once daily orally continuous dosing) until disease progression then second line everolimus (10 mg once daily orally continuous dosing)
16180088|NCT01545804|Drug|Lenalidomide|All enrolled patients will receive Lenalidomide, 25 mg orally daily, until objective disease progression, development of unacceptable toxicity, or voluntary discontinuation by the subjects.
16180089|NCT01545791|Drug|insulin detemir|Administered once or twice daily depending on patients' needs. Dose adjusted for each patient at the discretion of their treating physician
16180090|NCT01545778|Drug|Tapentadol IR|Opioid naive patients exposed to tapentadol IR from July 2009 to December 2010.
16180091|NCT01545778|Drug|Oxycodone IR|Opioid naive patients exposed to Oxycodone IR from July 2009 to December 2010.
16180092|NCT01545765|Drug|Lidocaine 7% + Tetracaine 7% cream|Study drug will be applied with a different application time to one side of the face and anterior thigh according to the randomization list.
16180093|NCT01545752|Other|teaching by non-interactive CD|teaching book with non-interactive CD
16180094|NCT01545752|Other|Interactive CD|Teaching book with interactive CD
16180095|NCT01545739|Device|Evia/Entovis HF-T pacemaker for CRT therapy|Implantation of CRT pacemaker and standard follow-ups at pre-hospital discharge, and after 1, 3 and 6 months
16180096|NCT01545726|Drug|QAW039|QAW039 was supplied as capsules for oral administration.
16180097|NCT01545726|Drug|Placebo|Placebo was supplied as capsules for oral administration.
16180098|NCT01545700|Drug|Control-saline|Patients are randomized to receive saline 2 cc
16180099|NCT01545700|Drug|Dexamethasone 4 mg|Patients randomized to receive dexamethasone 4mg and 1 cc saline
16180100|NCT01545700|Drug|Dexamethasone 8 mg|Patients randomized to receive dexamethasone 8mg
16180102|NCT01545700|Drug|Dexamethasone 4 mg|Patients are randomized to receive dexamethasone 4 mg and saline 1 cc
16180103|NCT01545700|Drug|Dexamethasone 8 mg|Patients are randomized to receive dexamethasone 8 mg
16180104|NCT01545687|Dietary Supplement|Lactobacillus brevis CD2 lozenge|Dissolved orally
16180105|NCT01545687|Other|placebo|Dissolved orally
16180106|NCT01545674|Procedure|Blood Draw|Blood will be drawn from the mother and father
16180107|NCT01545661|Procedure|Sputum induction|Ultrasonic nebulisation 3% hypertonic saline nebulised for duration of 20 mins
16180108|NCT01545661|Procedure|standard routine expectorated sputum|Patients in the control group are trained by the research staff to produce sputum but no device is utilized. Sputum is spontaneously expectorated where possible
16180109|NCT01545648|Drug|Denosumab|"Formulation of Dosage forms
~The vial presentations of denosumab contain 60 mg/mL denosumab, 17 mM sodium acetate, and 4.7% (w/v) sorbitol, at a pH of 5.2, filled to a target deliverable volume of 1.0 mL; or 70 mg/mL denosumab, 18 mM sodium acetate and 4.6% (w/v) sorbitol, at a pH of 5.2, filled to a target deliverable volume of 1.7 mL. The prefilled syringe (PFS) drug product contains denosumab at 60 mg/mL, 17 mM sodium acetate, 4.7% (w/v) sorbitol, and 0.01% (w/v) polysorbate 20, at a pH of 5.2, filled to a target deliverable volume of 1.0 mL.
~Dosage: 120 mg, monthly for total of 6 months, then every 12 weeks for 2 doses, for a total treatment course of one year
~Route of administration: subcutaneous injection"
16180110|NCT01545635|Drug|Fibrinogen concentrate, Prothrombin complex concentrate and FXIII concentrate|"Fibrinogen concentrate Dose: 50 mg/kg BW fibrinogen concentrate if FIBTEM A10<7mm Kind of application: Intravenously Frequency and rate of administration: Single-dose or repeated, each single vial (1g) over 5 min
~Prothrombin complex concentrate Dose: 20IE/kg BW PCC if EXTEM CT >90sec and FIBTEM A10>7mm Kind of application: Intravenously Frequency and rate of administration: Single-dose or repeated, each single dose over 10 min
~FXIII concentrate Dose: 20 IU/kg BW Fibrogammin® P will be administered with the second dose of fibrinogen concentrate (=100 mg/kg) and if FXIII decreases below 60% as detected by laboratory measurements.
~Kind of application: Intravenously Frequency and rate of administration: Single-dose or repeated, each single dose over 10 min"
16180111|NCT01545635|Drug|Fresh Frozen Plasma blood type 0, A, B and AB|Fresh Frozen Plasma Dose: 15ml/kg BW if FibTEM A10 <7mm and/or ExTEM CT>90sec. Kind of application: Intravenously Frequency and rate of administration: Single-dose or repeated, each single U (200mL) over 5 min
16180112|NCT01545609|Other|Text messaging|Text messages to cell phone with education messages about the specific birth control they are using
16180113|NCT01545596|Behavioral|Notification Group|Anesthesia team receives notification when a double low condition exists. The anesthesia team makes a decision to intervene or not.
16180114|NCT01545583|Drug|LY3016859 intravenous|Administered intravenously
16180115|NCT01545583|Drug|Placebo intravenous|Administered intravenously
16180116|NCT01545583|Drug|LY3016859 subcutaneous|Administered subcutaneously
16180117|NCT01545583|Drug|Placebo subcutaneous|Administered subcutaneously
16180118|NCT01545570|Drug|GSK2376497|GSK2376497 Active Comparator
16180119|NCT01545570|Drug|0.9% sodium chloride|0.9% sodium chloride Placebo Comparator
16180120|NCT01545557|Device|Hyaluronic acid dermal filler gel|1 injection per indication and 1 touch-up injection if necessary
16180121|NCT01545531|Drug|Iohexol|Iohexol, a non-ionic, low osmolar, X-ray contrast medium (OmnipaqueR) that is safe and non-toxic and used for angiographic and urographic procedures, is eliminated from plasma exclusively by glomerular filtration [13]. Study subject will receive 5 ml of iohexol solution (Omnipaque 300, corresponding to 647 mg iohexol per ml or 300 mg iodine per ml) through peripheral IV or central Line infusion over 1-2 minutes followed by 10 ml of saline solution at baseline, day 100 and 1 year after HCT.
16180122|NCT01545518|Drug|IVIG|IVIG 2 mg/kg in two divided doses with placebo crossover
16180123|NCT01545505|Behavioral|Neuropsychological assessment|"A clinical evaluation with Impact of Events Scale-Revised, Child Post-Traumatic Stress Reaction Index, State-Trait Anxiety Inventory for Children, Children Depression Inventory and Emotion, activity and sociability.
~A neuropsychological assessment with a emotional Go-No/Go, a visual search task, the Trail Making Test, 3 items of the WISC III ( and the Grober and Buschke Test."
16180124|NCT01545479|Drug|captopril 25mg|renal blood oxygenation after captopril
16180125|NCT01545466|Behavioral|Mindfulness Based Stress Reduction (MBSR)|MBSR involves 8 weekly 2 hour classes and one 4-6 hour retreat after the 6th class
16180126|NCT01545453|Drug|lebrikizumab|subcutaneous dose every 4 weeks
16180127|NCT01545453|Drug|lebrikizumab|subcutaneous dose every 4 weeks
16180128|NCT01545453|Drug|lebrikizumab|subcutaneous dose every 4 weeks
16180129|NCT01545453|Drug|placebo|subcutaneous dose every 4 weeks
16180130|NCT01545440|Drug|lebrikizumab|subcutaneous dose every 4 weeks
16180131|NCT01545440|Drug|lebrikizumab|subcutaneous dose every 4 weeks
16180132|NCT01545440|Drug|lebrikizumab|subcutaneous dose every 4 weeks
16180133|NCT01545440|Drug|placebo|subcutaneous dose every 4 weeks
16180134|NCT01545427|Drug|Imatinib mesylate|200 mg bid for 6 months
16180135|NCT01545427|Other|Placebo|Placebo coated to match appearance of Gleevec identically.
16180136|NCT01545414|Behavioral|ICBT|12 weeks of Internet-based Cognitive Behavioral Therapy with a focus on behavioral activation
16180137|NCT01545414|Behavioral|ICONTROL|12 weeks of Internet-based treatment with a focus on relaxation training
16180138|NCT01545401|Other|EMPOWER-PAR Intervention|"Implementation process is conducted in 3 phases:
~I. Phase 1: Formation and training of the CDM team
~II. Phase 2: Distributions of the intervention tools
~Global CV Risks Self-Management Booklets
~CPG to aid clinical decision making
~III. Phase 3: Facilitation and support to implement the intervention"
16180139|NCT01545388|Drug|Sitagliptin|Sitagliptin, orally, 50 or 100 mg tablet (continuation of the pre-study dose)
16180140|NCT01545388|Drug|Metformin|Metformin, orally, 500 mg daily (single dose; two 250 mg tablets) for 24 weeks
16180141|NCT01545388|Drug|Metformin|Metformin, orally, 500 mg daily (divided dose; 250 mg tablet b.i.d.) for 24 weeks
16180142|NCT01545388|Drug|Placebo|Placebo to match metformin 250 mg tablets, orally, for 24 weeks
16180143|NCT01545375|Biological|Pneumococcal vaccine GSK2189242A|4 doses administered intramuscularly
16180144|NCT01545375|Biological|Placebo|4 doses administered intramuscularly
16180145|NCT01545375|Biological|Prevnar 13®|4 doses administered intramuscularly
16180146|NCT01545375|Biological|PedvaxHIB®|4 doses administered intramuscularly
16180147|NCT01545362|Procedure|Total knee arthroplasty|Total knee arthroplasty
16180148|NCT01545349|Biological|Lactobacillus rhamnosus GG ATCC 53103 (LGG)|Study drug capsules (1x10^10 LGG/capsule) are to be taken orally twice a day every day on an outpatient basis for 28 days
16180149|NCT01545349|Biological|Placebo|Placebo capsules composed of microcrystalline cellulose are to be taken orally twice a day on an outpatient basis for 28 days.
16180150|NCT01545349|Biological|Live attenuated influenza vaccine|0.2 mL pre-filled, single use intranasal spray
16180151|NCT01545336|Drug|Anastrozole|1 mg tablet to be taken 1 time daily
16180152|NCT01545336|Drug|Placebo|1 mg tablet to be taken 1 time daily
16180153|NCT01545323|Genetic|One 20cm2/10cm2 autologous skin sheet graft|Adults will receive a graft of approximately 20cm2. Children under 16 years of age will receive a graft around half this size, around 10cm2 .The graft is derived from SPINK5 transduced cells
16180154|NCT01545310|Drug|SLV354|One dose of ABT-354
16180155|NCT01545297|Drug|Dexmedetomidine|The infusion begins at dexmedetomidine 0.3-0.4 mcg/kg/hr for 15 min, and then titrated down to 0.1-0.2 mcg/kg/hr.
16180156|NCT01545297|Drug|Propofol|The infusion begins at propofol 25-250 mcg/kg/min for 15 min, and then titrated to effect.
16180157|NCT01545297|Drug|Remifentanil|The infusion begins at remifentanil 0.01-0.1 mcg/kg/min for 15 min, and then titrated to effect.
16180158|NCT01545284|Drug|Acitretin|All patients will receive open-label single oral acitretin 10 mg capsule once daily as a starting dose. If well tolerated, the dose will be increased in the first 4 weeks to a maximum of 30mg/day. Patients will be instructed to take the treatment as a single oral dose with a meal.
16180159|NCT01545271|Drug|xenon gas|Inhalation via endotracheal tube of 50% xenon for 18 hours
16180160|NCT01545271|Device|Whole body cooling|Cooling of baby to reduce rectal temperature to 33.5 degree Centigrade(standard treatment)
16180161|NCT01545258|Other|Exercise|Physiotherapy supervised exercise training. 60 minutes 3 times per week
16180162|NCT01545232|Biological|1:1:1 Blood Transfusion Ratio|Group 1 will be randomized to receive the 1:1:1 ratio of plasma:platelets:RBC. Blood bank will prepare the initial container containing 6 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC; the blood bank will send the initial and all subsequent containers until notified of the discontinuation of the PROPPR transfusion protocol.
16180163|NCT01545232|Biological|1:1:2 Blood Transfusion Ratio|Group 2 will be randomized to receive the 1:1:2 ratio of plasma:platelets:RBC. The blood bank will prepare the initial container containing 3 units plasma, 0 units platelets and 6 units RBC, a second container containing 3 units plasma, 1 unit platelets (a pool of 6 units on average) and 6 units RBC, and the blood bank will send this sequence of 2 containers repeatedly, until notified of the discontinuation of the PROPPR transfusion protocol.
16180164|NCT01545219|Dietary Supplement|Prebiotic|8g/day xylo-oligosaccharide
16180165|NCT01545219|Dietary Supplement|Bi-07|10^9 CFU B. lactis / day
16180166|NCT01545219|Dietary Supplement|Synbiotic|8g/day xylo-oligosaccharide + 10^9 CFU Bi-07
16180167|NCT01545219|Dietary Supplement|Placebo|8g/day maltodextrin
16180168|NCT01545193|Other|Age and incidence of residual neuromuscular blockade|An older cohort is anticipated to have a higher incidence of residual neuromuscular blockade
16180169|NCT01545167|Genetic|blood sampling|blood samples obtained to extract biomarkers and dna for analysis, questionnaires
16180170|NCT01545154|Device|Transperineal Ultrasound|
16180171|NCT01545141|Drug|Chemokin Modulatory Regimen (5 MU/m2)|Celecoxib: 200 mg twice/day M-F of the week prior to scheduled surgery rintatolimod: 200 mg i.v. administration M-F of the week prior to scheduled surgery IFN: i.v. administration, M-F of the week prior to scheduled surgery. Dose escalation evaluating 5, 10, and 20 MU/m2.
16180172|NCT01545141|Drug|Chemokin Modulatory Regimen (10 MU/m2)|Celecoxib: 200 mg twice/day M-F of the week prior to scheduled surgery rintatolimod: 200 mg i.v. administration M-F of the week prior to scheduled surgery
16180173|NCT01545141|Drug|Chemokin Modulatory Regimen (20 MU/m2)|Celecoxib: 200 mg twice/day M-F of the week prior to scheduled surgery rintatolimod: 200 mg i.v. administration M-F of the week prior to scheduled surgery
16180174|NCT01545089|Other|Mattress protector for days 1 and 2|A mattress protector is placed in the bed for the first two days and then removed for days 3 and 4.
16180175|NCT01545089|Other|Mattress protector for days 3 and 4|A mattress protector is not placed in the bed for the first two days and then added to the bed for days 3 and 4.
16180176|NCT01545076|Biological|IgPro20 (low dose)|"20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization:
~0.2 g/kg body weight (low dose arm)"
16180177|NCT01545076|Biological|Placebo|2% human albumin administered by weekly SC infusions during the SC treatment period of the study.
16180178|NCT01545076|Biological|IgPro10|10% Immunoglobulin G (IgG) liquid formulation of human normal immunoglobulin (Privigen®) administered intravenously during Restabilization Period of the study and/or as Rescue Therapy during SC Treatment Period for subjects with a CIDP relapse.
16180179|NCT01545076|Biological|IgPro20 (high dose)|"20% liquid formulation (200 mg/mL) of human normal immunoglobulin for subcutaneous use administered weekly during the SC treatment period of the study according to the randomization:
~0.4 g/kg body weight (high dose arm)"
16180180|NCT01545050|Biological|Placebo matching with BMS-945429|Injection, Intravenous (IV), 0 mg, Day One Only, One Day
16180181|NCT01545050|Biological|Placebo matching with BMS-945429|Injection, Subcutaneous (SC), 0 mg, Every 4 weeks, 8 weeks
16180182|NCT01545050|Biological|Placebo matching with BMS-945429|Injection, Subcutaneous (SC), 0 mg, Week 4 Only, One Day
16180183|NCT01545050|Biological|Placebo matching with BMS-945429|Injection, Subcutaneous (SC), 0 mg, Every 4 weeks, Up to 48 weeks
16180184|NCT01545050|Biological|BMS-945429|Injection, Intravenous (IV), 600 mg, Day One Only, One Day
16180185|NCT01545050|Biological|BMS-945429|Injection, Subcutaneous (SC), 200 mg, Week 8 only, One Day
16180186|NCT01545050|Biological|BMS-945429|Injection, Intravenous (IV), 300 mg, Day One Only, One Day
16180187|NCT01545050|Biological|BMS-945429|Injection, Subcutaneous (SC), 100 mg, Week 8 Only, One Day
16180188|NCT01545050|Biological|BMS-945429|Injection, Subcutaneous (SC), 400 mg, Day One and Week 4, 4 weeks
16187755|NCT01488877|Drug|PF-03882845|up to 30 mg once daily
16180189|NCT01545050|Biological|BMS-945429|Injection, Intravenous (IV), 150 mg, Day One Only, One Day
16180190|NCT01545050|Biological|BMS-945429|Injection, Subcutaneous (SC), 100 mg, Every 4 weeks, Up to 48 weeks
16180191|NCT01545050|Biological|BMS-945429|Injection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 48 weeks
16180192|NCT01545050|Biological|BMS-945429|Injection, Subcutaneous (SC), 200 mg, Every 4 weeks, Up to 96 weeks, depending on when subject enters this period
16180193|NCT01545037|Dietary Supplement|L. acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2®|Each capsule contains 50 billion cfu live of Lactobacillus acidophilus CL1285® + L. casei LBC80R® + L. rhamnosus CLR2® bacterias. The randomized subjects will consume 2 capsules per day at breakfast.
16180194|NCT01545037|Other|Placebo|The placebo capsules are identical in shape, taste, and smell yet are devoid of live bacteria.
16180195|NCT01545024|Drug|Sitagliptin, 50 mg once per day per os|Before and one year after treatment with DPP-IV inhibitor in diabetic patients with AND.
16180196|NCT01545011|Other|Inspiratory muscle training|Inspiratory muscle training
16180197|NCT01544998|Drug|Nesiritide|10 ug/kg
16180198|NCT01544998|Drug|Tadalafil|5 mg
16180199|NCT01544998|Drug|Placebo|The pharmacy will create a placebo subcutaneous injection volume to match the volume of Nesiritide dose.
16180200|NCT01544998|Drug|Saline load|Normal saline 0.9% 0.25 ml/kg/min for 60 minutes
16180201|NCT01544985|Drug|88% sucrose po solution|88% sucrose solution (Syrup B.P.)
16180202|NCT01544985|Drug|placebo po|sterile water
16180203|NCT01544972|Drug|Oral paracetamol|Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours.
16180204|NCT01544972|Drug|Oral ibuprofen|Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.
16180205|NCT01544959|Drug|fentanyl|Use of esmolol and metoprolol compared to use of fentanyl for hemodynamic control during general anesthesia. At induction, fentanyl (2 mcg/kg) is replaced by esmolol (1 mg/kg). During the case, with a standardised anesthesia, response to surgical stimulation will be medicated either by fentanyl (50 mcg aliquot) or metropolol (2.5 mg), for a maximum of 6 doses. After this, fentanyl will be given unblindly.
16180206|NCT01544959|Drug|beta-blocker (esmolol, metropolol)|esmolol is used at induction and lopressor during surgery instead of fentanyl in response to surgical stimulation.
16180207|NCT01544946|Drug|88% sucrose po|88% sucrose solution (Syrup B.P.)
16180208|NCT01544946|Drug|placebo po|sterile water
16180209|NCT01544920|Biological|peg-Interferon alfa-2a|peg-IFN (180 ug) was taken once weekly via subcutaneous injection.
16180210|NCT01544920|Drug|Ribavirin|RBV 200 mg tablets taken by mouth at a total daily dose of 1,000 mg (body weight <75 kilograms [kg]) or 1,200 mg (body weight ≥75 kg) with total daily dose divided into 2 dosings.
16180211|NCT01544920|Drug|Boceprevir|Four 200 mg BOC capsules taken three times a day by mouth for a total daily dose of 2,400 mg.
16180212|NCT01544907|Device|Conventional PTA|Use of conventional balloon for angioplasty only
16180213|NCT01544907|Device|Drug Eluting Balloon (DEB)|Use of DEB after conventional balloon angioplasty
16180214|NCT01544894|Drug|Raloxifene|60 mg/d for one year
16180215|NCT01544894|Drug|Strontium ranelate|2 g/d, for one year
16180216|NCT01544881|Drug|Technosphere Insulin Inhalation Powder|Inhalation Powder using the Gen2C inhaler
16180217|NCT01544881|Drug|Rapid Acting Analog|Subcutaneous Injection
16180218|NCT01544868|Other|Use of Stable Isotope to Measure Energy Expenditure and Protein Turnover|Two pre-dose urine specimens will be collected prior to an oral dose containing 0.22 g/kg total body water of 100% 18O water (or 1.2 g/kg per body weight of 10% 18O water) and 0.11 g/kg per body weight of 99.9% deuterium oxide. Then the patient will receive a single dose (4mg/kg, less than 2% of normal daily intake of 1.1g per person) of 15N glycine tracer. For this, patients will drink a dose of 15N glycine (4mg.kg 1dissolved in 20 ml of saline) mixed in 50 cc of apple juice or other liquid beverage, followed by a 50 cc wash of water. 24 hour urine collection will commence immediately. Twenty-four hour urines will be used for determining the 15N NH3 and 15N urea enrichment. Each urine container will contain 5 ml of 15N HCl for trapping the urinary ammonium. Urine will be collected each day for 3 days, for determination of the total urinary nitrogen, urea creatinine, and ammonia excretion.
16180219|NCT01544855|Dietary Supplement|omega-3 fatty acids|Participants will take 700 mg/d of EPA and 500 mg/d of DHA as ethyl esters for one month (Ocean Nutrition, Dartmouth, NS) which is about 10 times the current estimated intake of young adults (21). This corresponds to one capsule with breakfast and one capsule with diner.
16180220|NCT01544842|Drug|0.1 % tacrolimus ointment|applied topically to oral mucosa
16180221|NCT01544842|Drug|0.1 % triamcinolone paste|applied topically to oral mucosa
16180222|NCT01544842|Drug|Orabase paste|applied topically to oral mucosa
16180223|NCT01544829|Dietary Supplement|Theobromine|Single dose of theobromine
16180224|NCT01544829|Dietary Supplement|Theobromine|Multiple doses of theobromine
16180225|NCT01544829|Dietary Supplement|Placebo|Placebo capsules
16180226|NCT01544816|Other|Snack Product|control food product
16180227|NCT01544816|Other|Snack Product|Experimental food product containing ingredient 1
16180228|NCT01544816|Other|Snack Product|Experimental food product containing ingredient 2
16180229|NCT01544803|Behavioral|eScreen|The eScreen brief Internet intervention for problematic alcohol and drug use offers self-screening, in-depth self-reporting, personalized feedback and treatment recommendations as well as an electronic diary. Progress over time is shown in diagrams detailing consumption levels.
16180230|NCT01544803|Behavioral|Alkoholhjalpen|An extensive Internet intervention for problematic alcohol use, Alkoholhjalpen,provides CBT- and MI-based psycho-education with a solution-oriented focus, electronic diary and moderated chat-forum.
16180231|NCT01544790|Procedure|Esophagectomy|In this monocenter prospective randomized controlled trial, we compare robot-assisted minimally invasive esophagectomy with conventional open transthoracic esophagectomy.
16180232|NCT01544777|Device|Study IOL|Aspheric IOL for correction of aphakia
16180233|NCT01544777|Device|Hoya iSert 751|Model 751 in one eye, standard IOL in other eye
16180234|NCT01544777|Device|Negatively aspheric IOL|Negatively aspheric IOL in both eyes
16180379|NCT01543802|Drug|pazopanib|Treatment with pazopanib 800 mg qd for 21 days followed by resection of the tumor after a 7-14 days break
16180235|NCT01544764|Other|Assessment , Feedback, Incentives, and eXchange Program|The NC Immunization Branch uses Adolescent AFIX (Assessment, Feedback, Incentives and eXchange) Program, a quality improvement strategy developed by the CDC to improve the immunization practices and vaccination coverage levels of public and private health care providers. It has four main components: 1) Assessment of a provider's current immunization practices and vaccination levels, 2) Feedback of the assessment results and strategies to improve coverage levels, 3) Incentives to improve coverage levels, and 4) eXchange of information and resources necessary to facilitate improvement.
16180236|NCT01544751|Drug|Low dose metformin|500 mg twice a day
16180237|NCT01544751|Drug|Metformin|1000 mg twice a day
16180238|NCT01544751|Drug|Atorvastatin|20 mg/day
16180239|NCT01544738|Other|Aponeurotic stimulation (the diacutaneous fibrolysis method)|Treatment consisted of manipulating, with a hook, the aponeurotic tissues enrobing the heads of the upper-limb muscles. The manipulation consisted of back and forth mobilization, applied perpendicularly to the axis of the muscular fibers. The mobilization is performed with both hands; the therapist's non-dominant hand performs a manual mobilization whereas the dominant hand follows the movement with the hook. The hook allows the therapist to be very precise about the location of the tissues that are stretched. This stretch is realized at the level of the aponeurotic fibers presenting the greatest resistance to perpendicular movement. The shape of the hook is chosen to avoid discomfort or pain during manipulation. To spread the pressure exerted by the spatula on a very local point, it is important to fill completely the curved part of the hook with the adjacent soft tissues. We manipulated muscle from the proximal insertion towards the distal, giving special attention to the tendons.
16180240|NCT01544738|Other|Placebo stimulation|Placebo stimulation (PS) consisted of manipulating the skin along the same paths over the trunk, shoulder and arm muscles that were the targets for treatment in the AS group
16180241|NCT01544725|Drug|Procedural sedation with ketamine-propofol combination|"K= Kétamine P= Propofol RSS= Ramsay Sedation Score
~At t0: 0.5 mg/kg of K (0.1 ml/kg of 5 mg/ml K) followed by 0.5 mg/k of P (0.1 ml/kg of 5 mg/ml P).
~At t0 + 4 min, if needed to obtain an optimal sedation (RSS of 4 or 5): 0.25 mg/kg of K (0.05 ml/kg of 5 mg/ml K) followed by 0.25 mg/kg of P (0.05 ml/kg of 5 mg/ml P).
~At t0 + 8 min, if needed to obtain an optimal sedation (RSS of 4 or 5): 0.25 mg/kg of K (0.05 ml/kg of 5 mg/ml K) followed by 0.25 mg/kg of P (0.05 ml/kg of 5 mg/ml P).
~At t0 + 12 min, if maximal doses have been reached (1 mg/kg of K + 1 mg/kg of P) but the optimal sedation has not been obtained, the procedural sedation will be recorded as a failure in the analysis, and the patient will receive another procedural sedation product (at the discretion of the caregiver)."
16180242|NCT01544725|Drug|Procedural sedation with ketamine alone|"K= Ketamine I= Intralipid placebo
~At t0: 1 mg/kg of K (0.1 ml/kg of 10 mg/ml K), followed by 0.1 ml/kg of I (physical placebo of propofol in the other arm).
~At t0 + 4 min, if needed to obtain an optimal sedation (Ramsay Sedation Score of 4 or 5): 0.5 mg/kg of K (0.05 ml/kg of 10 mg/ml K), followed by 0.05 ml/kg of I.
~At t0 + 8 min, if needed to obtain an optimal sedation (Ramsay Sedation Score of 4 or 5): 0.5 mg/kg of K (0.05 ml/kg of 10 mg/ml K), followed by 0.05 ml/kg of I.
~At t0 + 12 min, if maximal doses have been used (2 mg/kg of K) but the optimal sedation has not been obtained, the procedural sedation will be recorded as a failure in the analysis, and the patient will receive another procedural sedation product (at the discretion of the caregiver)."
16180243|NCT01544712|Procedure|core decompression with autologous bone marrow implantation|core biopsy with injection of 40 ml concentrated autologous bone marrow.
16180244|NCT01544712|Procedure|core decompression of the femoral head|core biopsy with injection of 40 ml saline solution in place of bone marrow.
16180245|NCT01544699|Device|tDCS (ELDITH)|tdcs (ELDITH, Neuroconn, Ilmenau, Germany) transcranial direct current stimulation
16180246|NCT01544686|Device|3M™ Tegaderm™ CHG IV and 3M™ Tegaderm™ Advanced IV|Patients receive the 3M™ Tegaderm CHG IV securement dressing or the 3M Tegaderm Advanced IV securement dressing after placement of a central venous catheter.
16180247|NCT01544673|Drug|linezolid|600 mg oral tablet twice daily for 4.5 days
16180248|NCT01544673|Drug|Placebo|500 mg oral placebo twice daily for 4.5 days
16180249|NCT01544647|Other|Usual spa protocol|In the first group, 4 treatments (massages, showers, mud and pool sessions) are provided 6 days a week during 3 weeks.
16180250|NCT01544647|Other|Active spa protocol|4 treatments (massages, showers, mud and pool sessions) are provided 3 days a week during 3 weeks then patients will follow an exercise program 3 days a week during 3 week.
16180251|NCT01544634|Drug|Propranolol|Propranolol: 10mg bd for 1 week, 20mg bd for 2 weeks, 80mg MR for 4 weeks.
16180252|NCT01544634|Drug|Placebo|Placebo tablets: 1 tab bd for 2 weeks, 1 tab od for 4 weeks
16180253|NCT01544634|Drug|Qvar 50|Qvar 50, 1 puff bd for 6 weeks
16180254|NCT01544634|Drug|Qvar 100|Qvar 100, 2 puffs bd for 6 weeks
16180255|NCT01544621|Other|Smoking cessation|Smoking cessation
16180256|NCT01544595|Drug|Secukinumab (AIN457)|"Secukinumab is a new type of psoriasis medication called a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a messenger protein in the body) called Interleukin 17 (IL-17). IL-17 is believed to be partly responsible for inflammation (pain, swelling, redness). Researchers believe that IL-17 causes symptoms of plaque-type psoriasis like plaques and scales. A product that targets IL-17 therefore may help to relieve these symptoms and conditions."
16180257|NCT01544595|Drug|Placebo|Placebo
16180258|NCT01544569|Genetic|DNA analysis|
16180259|NCT01544569|Genetic|fluorescence in situ hybridization|
16180260|NCT01544569|Genetic|gene expression analysis|
16180261|NCT01544569|Genetic|gene mapping|
16180262|NCT01544569|Genetic|microarray analysis|
16180263|NCT01544569|Genetic|polymerase chain reaction|
16180264|NCT01544569|Genetic|protein expression analysis|
16180265|NCT01544569|Other|laboratory biomarker analysis|
16180266|NCT01544569|Other|medical chart review|
16180267|NCT01544530|Other|Cold isotonic fluid and central venous hypothermia catheter|20-30ml/kg of isotonic crystalloid resuscitation fluid will be used for induction. Hypothermia (32-33 degrees C) will be sustained until organ procurement using an FDA approved central venous catheter connected to an external temperature regulating system
16180268|NCT01544517|Drug|Eradication therapy (amoxicillin; esomeprazole; tinidazole; levofloxacin)|amoxicillin tablets 1 g; esomeprazole tablets 40mg; tinidazole tablets 500mg; levofloxacin tablets 500 mg
16180269|NCT01544504|Drug|Norepinephrine|Approximately 4.65 mL of a norepinephrine solution (400 mM, 82.3 mg/mL) will be applied topically to the study drug application site prior to each radiotherapy treatment (approximately 25-28 treatments).
16180270|NCT01544491|Drug|RAD001|Everolimus (C0 trough level of 3-8 ng/mL) in combination with reduced dose tacrolimus and steroids withdrawal at 6 months after transplant
16180271|NCT01544491|Drug|MMF|MMF (Cellcept®): 600mg/m2/dose twice daily (1200 mg/m2/day) in combination with tacrolimus (Prograf) and standard dose steroids
16180272|NCT01544478|Biological|V501|HPV types 6, 11, 16, and 18 vaccine 0.5 mL by intramuscular injection at Day 1, Month 2, and Month 6
16180273|NCT01544465|Behavioral|Structured Physical Activity|Rehabilitation evaluation and 8 weeks of physical therapy
16180274|NCT01544465|Behavioral|Sleep hygiene education|Educational materials on insomnia published by the American Academy of Sleep medicine
16180275|NCT01544452|Procedure|MR colonography and MR of the liver|Altered planned surgical procedure if MR colonoscopy reveals synchronous cancer or larger polyps
16180276|NCT01544452|Procedure|Standard diagnostic evaluation|Altered planned surgical procedure if MR colonoscopy reveals synchronous cancer or larger polyps
16180277|NCT01544439|Procedure|stabilizing appliance|The reversible occlusal therapy be made by the same dental technician and will be adjusted by the same dentist, therapist represented by the researcher. Will be played simultaneous occlusal contacts in centric relation position and malocclusion by canine and protrusive guides. The patients will be assessed at weekly intervals (between the query and the following board installation) and then biweekly during the period of 90 days. There shall be a gradual reduction in the daily use of the plate, and the first two weeks the device is indicated for 24 hours a day, being removed only for eating and cleaning. At each visit clinical follow-up, shall be established a gradual reduction in the time of use so that the last three weeks of treatment are achieved 8h/day use.
16180278|NCT01544439|Procedure|Non-occluding splint, counseling|The non-occlusive splint (placebo) will also be made by the same dental technician. They did not interfere with the occlusal tooth gear, ie, do not alter the position of closing jaws. They are adjusted based on the verification of the occlusion, so that the card does not interfere with movements or maximum intercuspation excursive lateral and protrusion, so that only the patient's teeth come into contact, without interference from the resin and the acrylic staple . The assessment of these patients occur at the same intervals recommended for patients in the experimental group being established on the same treatment protocol with respect to the daily use of the splint.
16180279|NCT01544426|Procedure|Office hysteroscopy and endometrial snip|Office hysteroscopy with endometrial snip
16180280|NCT01544426|Procedure|Office hysteroscopy|Office hysteroscopy
16180281|NCT01544413|Procedure|Laparoscopic sentinel lymph node biopsy|During the operation, endoscopic marking was perfomed using Tc 99m HSA and indocyanine green around tumor. Then we identify the sentinel lymph node with laparoscopic probe. Laparoscopic sentinel lymph nodes were dissedted and evaluated them at the backtable in the operating room.
16180282|NCT01544387|Other|Bed Rest|"Subjects are admitted to their labor and delivery room and will spend the majority of their day in their hospital bed, usually in a reclined or sleeping position
~Subjects will be instructed to refrain from walking or engaging in any extraneous activity, including lifting or spending any extended period of time out of bed
~Subjects may have limited bathroom privileges"
16180283|NCT01544387|Other|Activity|"Subjects are admitted to their labor and delivery room and will spend the majority of their time in their hospital bed
~Subjects will be given the opportunity of 3 periods of walking around their room and/or the hall on labor and delivery each day, each period consisting of approximately 20 minutes - this is the minimum activity level required for the study. Subjects are permitted more activity as desired."
16180284|NCT01544374|Other|Tracking & Feedback|Systems based intervention tracking oncology consultations and feeding back information to surgeons
16180285|NCT01544361|Other|Placebo|A single dose of placebo matched to MEDI7814 intravenous infusion over at least 60 minutes on Day 1.
16180286|NCT01544361|Biological|MEDI7814, 1 MG/KG|A single dose of MEDI7814, 1 mg/kg intravenous infusion over at least 60 minutes on Day 1.
16180287|NCT01544361|Biological|MEDI7814, 3 MG/KG|A single dose of MEDI7814, 3 mg/kg intravenous infusion over at least 60 minutes on Day 1.
16180288|NCT01544361|Biological|MEDI7814, 10 MG/KG|A single dose of MEDI7814, 10 mg/kg intravenous infusion over at least 60 minutes on Day 1.
16180289|NCT01544361|Biological|MEDI7814, 20 MG/KG|A single dose of MEDI7814, 20 mg/kg intravenous infusion over at least 60 minutes on Day 1.
16180290|NCT01544348|Other|Placebo|A single dose of placebo matched to MEDI4212 subcutaneous injection or intravenous infusion on Day 1.
16180291|NCT01544348|Biological|Omalizumab|A single flexible dose of omalizumab between 150 to 375 milligram (mg) injection based upon participant's Immunoglobulin E (IgE) levels and body weight subcutaneously on Day 1.
16180292|NCT01544348|Biological|MEDI4212 5 mg Subcutaneous|A single dose of MEDI4212 5 mg injection subcutaneously on Day 1.
16180293|NCT01544348|Biological|MEDI4212 15 mg Subcutaneous|A single dose of MEDI4212 15 mg injection subcutaneously on Day 1.
16180294|NCT01544348|Biological|MEDI4212 60 mg Subcutaneous|A single dose of MEDI4212 60 mg injection subcutaneously on Day 1.
16180295|NCT01544348|Biological|MEDI4212 150 mg Subcutaneous|A single dose of MEDI4212 150 mg injection subcutaneously on Day 1.
16180296|NCT01544348|Biological|MEDI4212 300 mg Subcutaneous|A single dose of MEDI4212 300 mg injection subcutaneously on Day 1.
16180297|NCT01544348|Biological|MEDI4212 300 mg Intravenous|A single dose of MEDI4212 300 mg intravenous infusion over 120 minutes on Day 1.
16180298|NCT01544335|Other|Bioimpedance Spectroscopy|BIS used to measure fluid in arm
16180299|NCT01544322|Drug|ME-344|"experimental drug, dose escalation with 5 planned dose cohorts of 1.2 mg/kg, 2.5 mg/kg, 5 mg/kg, 10 mg/kg, 20 mg/kg; Cycle 1 is 3 weekly IV infusions on Days 1, 8, and 15. After safety assessment, if there is clinical benefit, weekly dosing may continue until withdrawal.
~Once the highest tolerated dose has been determined, patients will be enrolled to receive IV infusions 2 days each week. Cycle 1 at the highest dose level is 3 weekly IV infusions on days 1, 2, 8, 9, 15 and 16. After safety assessment, if there is clinical benefit, weekly dosing may continue until withdrawal."
16180300|NCT01544309|Drug|Atorvastatin|"Atorvastatin 10 mg (atorvastatin 10 mg tablet x 1 or atorvastatin 5 mg tablet x 2), orally,once daily for 12 months.
~(When not reach the LDL-C level of target in the Japan Atherosclerosis Society [JAS] Guidelines [GL] after 3 months, had the atorvastatin [ATV] dose of 20 mg.)"
16180301|NCT01544309|Drug|Rosuvastatin|"Rosuvastatin 5 mg (rosuvastatin 5 mg tablet x1 or rosuvastatin 2.5 mg tablet x 2), orally, once daily for 12 months.
~(When not reach the LDL-C level of target in JAS GL after 3 months, had the rosuvastatin [RSV] dose of 10 mg.)"
16180302|NCT01544296|Drug|KHK6188|
16180303|NCT01544296|Drug|Placebo|
16180304|NCT01544283|Drug|Synera® (lidocaine 70 mg and tetracaine 70 mg) topical patch|Synera consists of a thin, uniform layer of a local anesthetic formulation with an integrated, oxygen-activated heating component that is intended to enhance the delivery of the local anesthetics. The drug formulation is an emulsion in which the oil phase is a eutectic mixture of lidocaine 70 mg and tetracaine 70 mg. The surface area of the entire Synera patch is approximately 50 cm2, 10 cm2 of which is active. The 40 cm2 perimeter is a medical grade adhesive. The Synera patches used in this study are the commercially available form.
16180305|NCT01544283|Drug|Triamcinolone Acetonide|Triamcinolone Acetonide is a synthetic glucocorticoid corticosteroid with marked anti-inflammatory action, in a sterile aqueous suspension suitable for intralesional and intra-articular injection. Each mL of the sterile aqueous suspension provides 40 mg of triamcinolone acetonide, with sodium chloride for isotonicity, 0.9% (w/v) benzyl alcohol as a preservative, 0.75% carboxymethylcellulose sodium, and a 0.04% polysorbate 80; sodium hydroxide or hydrochloric acid may have been added to adjust pH between 5.0 and 7.5. At the time of manufacture, the air in the container is replaced by nitrogen.
16180306|NCT01544270|Dietary Supplement|Yogurt-like snacks|twice a day 120 g for four weeks
16180307|NCT01544257|Other|osteopathic manipulative treatment|Patients from this group received osteopathic treatments twice a week for the entire length of stay in the unit.
16180308|NCT01544257|Procedure|Usual care|Patients from control group received standard care plus osteopathic evaluation only, according to the same schedule as the study group.
16180309|NCT01544244|Procedure|GSC physical therapy|Global Shoulder Concept physical therapy sequence for shoulder tendonitis. The procedures used in this protocol refer to physical therapy sequences, not to devices or drugs.
16180310|NCT01544244|Procedure|Standard physical therapy|Standard physical therapy sequence for shoulder tendonitis. The procedures used in this protocol refer to physical therapy sequences, not to devices or drugs.
16180311|NCT01544231|Biological|Plasma NGAL level|The plasmatic level of Neutrophil Gelatinase Associated Lipocalin is measured in ng/ml/
16180312|NCT01544205|Other|fMRI-based neurofeedback|5 sessions lasting one hour each
16180313|NCT01544192|Drug|Gingko Biloba|2x60 mg Gingko Biloba (Vega Natural, Konya, Turkey)
16180314|NCT01544192|Drug|α-tocopherol|2x300 mg α-tocopherol
16180315|NCT01544192|Drug|Placebo|control group did not receive oral neuroprotective agent
16180316|NCT01544192|Drug|Antioxidant formula|2x1 tablet AOF
16180317|NCT01544179|Drug|Gefitinib|Investigational Drug
16180318|NCT01544179|Drug|Placebo|Matching placebo as comparator
16180319|NCT01544179|Drug|Pemetrexed|Chemotherapy (concomitant therapy)
16180320|NCT01544179|Drug|Cisplatin|Chemotherapy (concomitant therapy)
16180321|NCT01544166|Drug|Gadobutrol (Gadavist, BAY86-4875)|Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants <2 years of age.
16180322|NCT01544153|Behavioral|WEB|Usual services available through www.BecomeAnEX.org, a publicly available, evidence-based smoking cessation website.
16180323|NCT01544153|Behavioral|Social Network|"Proactive communications from established members of the community (Integrators) designed to integrate study participants into the online social network on BecomeAnEX.org."
16180324|NCT01544153|Behavioral|Nicotine Replacement Therapy (NRT)|A free 4-week supply of nicotine replacement therapy (patch, gum, or lozenge), provided as an over-the-counter product, meaning that no additional support or guidance will be provided to parallel the experience subjects would have if they purchased NRT on their own.
16180325|NCT01544140|Drug|Midazolam|Oral syrup 7.5 mg, single dose
16180326|NCT01544140|Drug|vandetanib|Oral tablets, 800 mg, single dose
16180327|NCT01544127|Behavioral|MI-SI+TAU|MI-SI focuses on exploring and resolving ambivalence about living. It consists of 1 or 2 in-person MI-SI sessions (50 mins.) on an inpatient unit, plus a telephone follow-up MI-SI session (30-50 mins)
16180328|NCT01544127|Behavioral|MI-SI-R+TAU|MI-SI-R focuses on resolving ambivalence about living. It consists of 1 or 2 in-person MI-SI sessions (50 mins.) on an inpatient unit, plus a telephone follow-up MI-SI session (30-50 mins)
16180329|NCT01544127|Other|TAU Alone|Inpatient treatment includes medication management, case management, meals and a bed, milieu therapy consisting of creative and social activities, and a safety plan. Some families of veterans also received education to create a supportive home environment. As part of Veterans Health Administration (VHA) suicide prevention policy, the care of suicidal patients is also overseen by a local Suicide Prevention Coordinator and case managers.
16180330|NCT01544114|Drug|VIMOVO 250/20|250 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
16180331|NCT01544114|Drug|VIMOVO 375/20|375 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
16180332|NCT01544114|Drug|VIMOVO 500/20|500 mg naproxen/20 mg esomeprazole magnesium oral tablet administered twice daily for up to 6 months
16180333|NCT01544101|Other|Vegan Diet|Vegan diet, which is devoid of animal products and minimal in fat
16180334|NCT01544101|Dietary Supplement|dietary supplement omega3 fatty acids aand vitamins|mixture of omega3 fatty acids aand vitamins
16180335|NCT01544088|Behavioral|Group Cognitive Behavioral Treatment (GCBT)|GCBT is a 14 week intervention that includes components of exposure (imaginal and in vivo), cognitive restructuring, and relapse prevention.
16180336|NCT01544088|Behavioral|Present Centered Group Treatment|The active comparison treatment is a 14 week treatment that focuses on here and now problems, especially problem solving skills concerning ongoing stressors.
16180337|NCT01544075|Behavioral|Pain neurophysiology education (PNE) and psychologic inoculation (PI)|3 sessions of PNE+PI are given which include education on pain neurophysiology and applying the PI technique for which subjects are asked to refute sentences which are read by the therapist.
16180338|NCT01544075|Behavioral|Neck school (NS)|3 sessions of NS which includes advice on posture, ergonomics and on performing activities.
16180380|NCT01543789|Procedure|Intraperitoneal mesh placement|Mesh placement inside the peritoneal cavity.
16180381|NCT01543789|Procedure|Preperitoneal mesh placement|Mesh placement between peritoneum and muscle layer.
16180339|NCT01544062|Drug|IV acetaminophen|Total of 6 doses of 1,000 mg IV acetaminophen at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.
16180340|NCT01544062|Drug|Placebo|Total of 6 doses of 100 mL of normal saline at the following time points: (1) immediately after anesthesia induction, but prior to the incision, (2) at the end of surgery with (3) four additional doses administered postoperatively in the ICU every 6 hours for the first 24 hours.
16180341|NCT01544036|Drug|perflutren|Contrast Enhanced Ultrasound is performed during continuous intravenous infusion of Definity (drug) to assess changes in renal blood flow during the study
16180342|NCT01544010|Behavioral|Stage-Tailored Manual|Manual with 5 sections for each Stage of change delivered at baseline
16180343|NCT01544010|Behavioral|Stage Tailored Feedback Report|Tailored printed feedback reports based on assessments of stages of change were delivered at baseline, 6 months and 12 months.
16180344|NCT01544010|Behavioral|Moderate TTM-Tailored Feedback Report|Tailored printed feedback report based on assessment of stages of change, Pros, Cons, and Temptations were delivered at baseline, 6 months and 12 months.
16180345|NCT01544010|Behavioral|Full TTM-Tailored Feedback Report|Tailored print feedback report based on assessment of Stages, Pros, Cons, Temptations, 10 Processes of Change were delivered at baseline, 6 months and 12 months.
16180346|NCT01544010|Behavioral|Enhanced TTM+Addiction Tailored Feedback Report|Tailored print feedback report based on assessment of Addiction level (# cigarettes/day),Stages, Pros, Cons, Temptations, 10 Processes of Change were delivered at baseline, 6 months and 12 months.
16180347|NCT01543997|Behavioral|Mind-Body Bridging Program|Bridging aims to reduce the impact of negative thought patterns that contribute to stress in the body.
16180348|NCT01543997|Behavioral|Supportive Education|This intervention will provide educational lectures on disability, sleep hygiene, and current research on depression and nondirective, supportive discussions about these topics.
16180349|NCT01543984|Other|Tailored Physical Activity|Tailored Physical Activity (3*50 min/week in 10 weeks)
16180350|NCT01543984|Behavioral|Health Counselling|Health guidance (1,5h)
16180351|NCT01543971|Drug|TXA127|TXA127 : 300mcg/kg per day for 5 days, injection
16180352|NCT01543971|Drug|Neupogen (filgrastim)|Neupogen : 10mcg/kg per day for 5 days, injection
16180353|NCT01543958|Drug|Sevelamer carbonate|Patients will be administered two 800 mg tablets of Sevelamer carbonate orally three times a day for 8 weeks.
16180354|NCT01543958|Device|Sevelamer carbonate|
16180355|NCT01543945|Drug|Dexamethasone|4 mg iv before induction for high and extremely high risk
16180356|NCT01543945|Drug|Ondansetron|4 mg iv before ended surgery 30 min
16180357|NCT01543945|Drug|Dimenhydrinate|1 mg/kg iv before ended surgery 30 min
16180358|NCT01543932|Drug|Clopidogrel|Patient will be randomized to this intervention will receive in the first time the double dose of clopidogrel and after 15 days and 30 days we will control the responsivness of the study drug.
16180359|NCT01543932|Drug|Prasugrel|Patient will be randomized to this intervention will receive in the first time prasugrel and after 15 days and 30 days we will control the responsivness of the study drug.
16180360|NCT01543932|Drug|Ticagrelor|Patient will be randomized to this intervention will receive in the first time Ticagrelor and after 14 days and 28 days we will change their therapy with the high clopidogrel dose or Prasugrel (dual crossover).
16180361|NCT01543919|Drug|PH-797804|0.25 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
16180362|NCT01543919|Drug|PH-797804|1 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
16180363|NCT01543919|Drug|PH-797804|3 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
16180364|NCT01543919|Drug|PH-797804|6 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
16180365|NCT01543919|Drug|PH-797804|10 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
16180366|NCT01543919|Drug|Placebo|Placebo oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks
16180367|NCT01543906|Drug|QLT091001|oral QLT091001 administered once daily for 7 days
16180368|NCT01543893|Behavioral|Video instruction|"Participants will receive an elastic resistance tubing, an internet link and a poster with instructions to perform four different elastic resistance exercises Participants are encouraged to perform the exercises daily on weekdays during the next two weeks
~Link to exercises: http://www.jobogkrop.dk/Ondt-i-muskler-og-led/Ondt-i-nakke-skulder-og-arm/Elastikoevelser-for-nakke-skulder-og-arm"
16180369|NCT01543893|Behavioral|Personal instruction|"Participants will receive an elastic resistance tubing, an internet link and a poster with instructions to perform four different elastic resistance exercises Participants are encouraged to perform the exercises daily on weekdays during the next two weeks In addition to the video group, this group will also receive personal instruction during the two weeks.
~Link to exercises: http://www.jobogkrop.dk/Ondt-i-muskler-og-led/Ondt-i-nakke-skulder-og-arm/Elastikoevelser-for-nakke-skulder-og-arm"
16180370|NCT01543880|Drug|somatropin|Prescribed at the discretion of the treating physician according to product labelling
16180371|NCT01543867|Drug|somatropin|Prescribed at the discretion of the treating physician according to product labelling
16180372|NCT01543854|Drug|RLX030|Intravenous infusion of RLX030 over 20 hrs
16180373|NCT01543854|Drug|Placebo|Intravenous infusion of placebo over 20 hours
16180374|NCT01543828|Drug|indacaterol|delivered via single-dose dry-powder inhaler
16180375|NCT01543828|Drug|placebo|delivered via single-dose dry-powder inhaler
16180376|NCT01543815|Behavioral|Well-Being Therapy based on Web Mobile Technology|The techniques included in WBT may be used in overcoming impairments in environmental mastery, purpose in life, personal growth, autonomy, self-acceptance and positive relations with others.
16180377|NCT01543815|Behavioral|Cognitive Behavior Therapy|CBT involves several essential features: identifying and correcting inaccurate thoughts associated with depressed feelings (cognitive restructuring); helping patients to engage more often in enjoyable activities (behavioral activation); enhancing problem-solving skills; providing instruction and guidance in specific strategies for solving problems.
16180378|NCT01543815|Other|Standardized Care Management|CM will consist of reviewing the patients' clinical status, and providing the patient with support and advice if necessary.
16180383|NCT01543763|Drug|PZP115891, PCI-24781|"PCI-24781: oral, 30 to 75 mg/m2 b.i.d. Cycle 1, Days -7 to -4 and Cycle 1 and ongoing - Days 1-5, 8-12, 15-19
~PZP115891: oral, 400 - 800 mg qd 28 days per cycle"
16180384|NCT01543750|Drug|4-Aminopyridine|
16180385|NCT01543750|Drug|Placebo|Placebo
16180386|NCT01543737|Device|3ml hyaluronic acid (DUROLANE)|DUROLANE Hyaluronic acid 20mg/ml
16180387|NCT01543737|Device|2ml hyaluronic acid, (HYALGAN)|HYALGAN Hyaluronic acid 10mg/ml
16180388|NCT01543724|Drug|Lithium|10mg/kg/day for 12 weeks
16180389|NCT01543698|Drug|LGX818|
16180390|NCT01543698|Drug|MEK162|
16180391|NCT01543698|Drug|LEE011|
16180392|NCT01543685|Drug|Indomethacin|40 mg TID capsules
16180393|NCT01543685|Drug|Indomethacin|40 mg BID capsules
16180394|NCT01543685|Drug|Indomethacin|20 mg TID capsules
16180395|NCT01543685|Drug|Celecoxib|200 mg capsules
16180396|NCT01543685|Drug|Placebo|Capsules
16180397|NCT01543672|Radiation|Stereotactic Body Radiotherapy (SBRT)|3-5 fractions within 10-14 days
16180398|NCT01543672|Radiation|Stereotactic Body Radiotherapy (SBRT)|3-5 fractions per tumor within one treatment session or sequential within one month
16180399|NCT01543659|Drug|89Zr-DFO-huJ591|The first 10 patients enrolled in the study will undergo serial whole-body scans to allow assessment of 89Zr-DFO-huJ591 biodistribution. There will be no intervening changes in therapy between the scans. The first 10 patients enrolled will also have serial blood samples drawn for PK analysis (2 -3 mL per time point). The remaining 90 patients enrolled (Patients 11-100) will have only 1 whole-body scan, at a time point to be determined based on the results for the first 10 patients. Biopsies are not mandatory, but highly recommended for the scientific purposes of the study. If feasible and the patient consents, all patients will undergo either or both of the following: (a) core biopsy of soft tissue site of disease; (b) core biopsy of bony site of disease. These biopsies will be performed following the last whole-body scan, prior to initiation of a new intervening therapy, and no more than 4 weeks after 89Zr-DFO-huJ591 administration.
16180400|NCT01543633|Drug|Propofol|Propofol will be infused using a computer controlled delivery system running the program STANPUMP. Loss of consciousness will be defined as loss of response to auditory stimulus (button press).
16180401|NCT01543607|Device|Radiofrequency ablation catheter (Habib EndoHBP)|Catheter placement into bile duct
16180402|NCT01543581|Drug|Vismodegib|Oral vismodegib, 150mg per day for 12 weeks.
16180403|NCT01543581|Drug|Placebo|
16180404|NCT01543568|Drug|aflibercept 2.0 mg|Intravitreal aflibercept injection 2.0 mg
16180405|NCT01543555|Drug|Atorvastatin|Atorvastatin 80mg anytime within 18 hours before surgery. A postoperative 40mg atorvastatin dose administered at least 12 hours after the 80mg loading dose. Subsequently, 40mg atorvastatin daily for the next seven days.
16180406|NCT01543555|Drug|Placebo|Matching placebo 80mg anytime within 18 hours before surgery. A postoperative 40mg matching placebo dose administered at least 12 hours after the 80mg loading dose. Subsequently, 40mg placebo daily for the next seven days.
16180407|NCT01543542|Radiation|Whole Brain XRT 30Gy/10 fractions with|30 Gy of whole brain external beam radiation delivered in 10 fractions. Simultaneous in-field boost of brain lesions to 60 Gy.
16180408|NCT01543529|Drug|RO4917838|Single dose of RO4917838
16180409|NCT01543529|Drug|Placebo to RO4917838|Single dose of placebo to RO4917838
16180410|NCT01543529|Other|Alcohol|Standard alcoholic drink
16180411|NCT01543490|Drug|ISV-305|Dexamethasone in DuraSite® 2 twice daily for 2 weeks
16180412|NCT01543490|Other|Vehicle|Vehicle twice daily for 2 weeks
16180413|NCT01543464|Drug|Chemotherapy: Temozolomide|Vaccine: 250 microgram IDO5 peptide + 250 microgram Survivin peptide + 500 microL Montanide every 2nd week Adjuvants: 75 microgram GM-CSF + 1 application Imiquimod every 2nd week
16180414|NCT01543451|Drug|Elsiglutide|24 mg administered s.c. once daily for 4 consecutive days from Day 1 chemotherapy
16180415|NCT01543451|Drug|Placebo|24 mg administered s.c. once daily for 4 consecutive days from Day 1 chemotherapy
16180416|NCT01543438|Other|Video Prescription (additional education)|receives video prescriptions
16180417|NCT01543412|Drug|FOLFIRI|Irinotecan 180 mg/m2 iv on day 1, Leucovorin(l-form) 200 mg/m2 iv on day 1,2 5-FU 400 mg/m2 iv bolus on day 1,2 5-FU 600 mg/m2 iv by ci for 22 hrs on day 1,2 repeated every 2 wks
16180418|NCT01543399|Drug|Tibolone|Experimental group will use 2.5mg of tibolone for 30 days
16180419|NCT01543399|Drug|Placebo|patients of the placebo group will use placebo one a day for 30 days
16180420|NCT01543386|Drug|Curcumin|The aim of this study is to determine if an oral loading-dose of curcumin can improve vascular endothelium reactivity in patients with moderate cardiovascular risk
16180421|NCT01543373|Device|Amphilimus Eluting Stent|Sirolimus formulated coronary eluting stent
16180422|NCT01543373|Device|Bare Metal Stent|Bare metal coronary stent
16180423|NCT01543360|Procedure|Axillary strategy|The first two attempts at central venous catheterization will be performed via the distal approach (axillary vein). The third and fourth attempts at central venous catheterization will be performed by the medial approach (subclavian vein). The same puncture material/devices will be used in both arms of the study.
16180424|NCT01543360|Procedure|Subclavian strategy|The first two attempts at central venous catheterization will be performed by the medial approach (subclavian vein). The third and fourth attempts at central venous catheterization will be performed by the distal approach (axillary vein). The same puncture material/devices will be used in both arms of the study.
16180425|NCT01543347|Drug|Temocillin|Antibiotic treatment
16180426|NCT01543334|Biological|Blood sampling|Blood samples will be harvested in one sequence at any time during the week set for the study. In patients receiving multiple antibiotics, multiple samples can be made (without exceeding the study of three antibiotics, ie a maximum of 6 tubes per patient). Two 3-ml tubes of blood will be collected for beta-lactams and glycopeptides (Sample A taken at half the time of the dosing interval and sample B at 30 minutes before the next dose). When patients receive continuous antibiotic treatment, both samples must be made at least 6 hours apart.
16180427|NCT01543321|Drug|Tetrabenazine|"Treatment with tetrabenazine consists in:
~5-week titration to a maximum dose of 200 mg / day
~5 weeks at stable dose
~2 weeks in wash-out
~The treatment will be blinded for patients and investigators"
16180628|NCT01541826|Dietary Supplement|Chokeberry Extract|Consumption of 2 x 250 mg chokeberry extract capsules daily for 12 weeks.
16180428|NCT01543321|Drug|Placebo|"Treatment with placebo consists in:
~5-week titration to a maximum dose of 200 mg / day
~5 weeks at stable dose
~2 weeks in wash-out
~The treatment will be blinded for patients and investigators"
16180429|NCT01543282|Device|Endosonography guided fine needle aspiration cytology ( Cook Medical, Boston Scientific)|Patients will be randomized either to receive EUS-FNA with a 22 g needle or 25 g needle. EUS-FNA passes will be performed without stylet until sample adequacy or until a maximum of 5 FNA passes in pancreatic lesions or 3 FNA passes in other lesions. In case of inadequate sample after 3 passes, or needle failure, cross over to the other type of needle is allowed.
16180430|NCT01543269|Drug|ZYT1|Oral dose of ZYT1 in fasting condition with 240±10 ml of water at sitting position in ambient temperature.
16180431|NCT01543269|Drug|Placebo tablets|Oral dose of Placebo in fasting condition with 240±10 ml of water at sitting position in ambient temperature.
16180432|NCT01543256|Device|WallFlex™ Biliary RX Fully Covered Stent System RMV|Temporary placement of the WallFlex Biliary RX Fully Covered Stent for treatment of benign biliary strictures secondary to chronic pancreatitis. The stent will be removed after 12 months indwell.
16180433|NCT01543256|Device|Commercially available Plastic Stent Per Investigator preference|Temporary placement/exchange of multiple biliary plastic stents for treatment of benign biliary strictures secondary to chronic pancreatitis. Stents will be removed after cumulative indwell of 12 months.
16180434|NCT01543243|Device|Stochastic resonance whole-body vibration A|"Immediate effects (one minute after intervention): over 5 sets with 6 Hz, Noise 4 and than 1 Hz, Noise 1.
~Long term effect: over four weeks, three times a week with 6 Hz, Noise 4 and than over four weeks three times a week with 1 Hz, Noise 1."
16180435|NCT01543243|Device|Stochastic resonance whole-body vibration B|"Immediate effects (one minute after intervention): over 5 sets with 1 Hz, Noise 1 and than 6 Hz, Noise 4.
~Long term effect: over four weeks, three times a week with 1 Hz, Noise 1 and than four weeks three times a week with 6 Hz, Noise 4."
16180436|NCT01543230|Device|Total hip replacement|Total hip arthroplasty (THA) using CoMplete™ Acetabular Hip System
16180437|NCT01543217|Other|RT management|Patients assigned to the RT management arm will receive a 1-hour educational in-service conducted by a respiratory therapist case manager. The patient education session will include general information about COPD, direct observation of inhaler techniques, a review and adjustment of outpatient COPD medications, smoking cessation counseling, recommendations concerning influenza and pneumococcal vaccinations, encouragement of regular exercise, and instruction in hand hygiene.
16180438|NCT01543217|Other|Ususal care|Routine respiratory care.
16180439|NCT01543204|Drug|Etanercept|Administered by subcutaneous injection
16180440|NCT01543191|Drug|PUR118|low dose and high dose for 3 doses, BID
16180441|NCT01543178|Drug|open-label rifaximin|550 mg three times a day (open-label)
16180442|NCT01543178|Drug|double-blind placebo|3 times a day (double-blind)
16180443|NCT01543178|Drug|double-blind rifaximin|550 mg three times a day (double-blind)
16180444|NCT01543165|Drug|Ketorolac and nefopam balanced analgesia|Sequential intravenous administration of ketorolac and nefopam
16180445|NCT01543165|Drug|Balanced analgesia using ketorolac and morphine|Sequential intravenous administration of ketorolac and morphine
16180446|NCT01543165|Drug|Pain control with single analgesics (ketorolac)|This arm do not use balanced analgesia. Instead, ketorolac IV administration followed by 50cc normal saline administration (for blinding) will be used in this group.
16180447|NCT01543152|Genetic|SB-728-T|Infusion will be 5 to 30 billion ZFN modified CD4+ T cells 1 day following IV cyclophosphamide 200 mg
16180448|NCT01543152|Genetic|SB-728-T|Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 0.5 g/m2
16180449|NCT01543152|Genetic|SB-728-T|Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.0 g/m2
16180450|NCT01543152|Genetic|SB-728-T|Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 2.0 g/m2
16180451|NCT01543152|Genetic|SB-728-T|Infusion will be 5 to 30 billion ZFN modified CD4+ T cells up to 3 days following IV cyclophosphamide 1.5 g/m2
16180452|NCT01543139|Drug|Valproate+Cytidine-+Creatine-|Valproate: Week0-8: 300mg/day, Cytidine-: Week0-8: 2g/day, Creatine-: Week0-1: 3g/day Week1-8: 5g/day
16180453|NCT01543139|Drug|Valproate+Cytidine-|Valproate: Week0-8: 300mg/day, Cytidine-: Week0-8: 2g/day
16180454|NCT01543139|Drug|Valproate|Valproate: Week0-8: 300mg/day
16180455|NCT01543113|Other|sequencing|sequencing
16180456|NCT01543100|Other|blood and bone marrow samples|"Specific tests of the study will be realized from :
~Blood samples: 2 EDTA tubes and 1 tube without anticoagulant per included patient.
~Bone marrow: 3 ml collected during of myelogram punction made for the diagnosis.
~In all cases, no additional sampling will be performed."
16180457|NCT01543087|Procedure|blood sampling|Blood sample collection at different time points
16180458|NCT01543087|Drug|bivalent rLP2086|A booster dose of bivalent rLP2086 at approximately 48 months following the final dose of the 2- or 3-dose primary bivalent rLP2086 vaccination series will be given at Visit 7.
16180459|NCT01543074|Dietary Supplement|BSE placebo|2 pills = 0 micromoles of Sulforaphane/day
16180460|NCT01543074|Dietary Supplement|Garlic oil|1 pill = 30 mg garlic oil/day
16180461|NCT01543074|Drug|BSE|2 pills = 200 micromoles of Sulforaphane/day
16180462|NCT01543074|Dietary Supplement|Garlic Oil Placebo|1 pill = 0 mg garlic oil/day
16180463|NCT01543061|Device|OPTIVEtm Plus|1 drop in each eye four times a day for a period of 30 (± 3) days
16180464|NCT01543061|Procedure|No treatment|One month of contact lens wear with no eye drop use
16180465|NCT01543061|Device|Blink Contacts® Eye Drops|1 drop in each eye four times a day for a period of 30 (± 3) days
16180466|NCT01543048|Other|Study Follow-Up|Colposcopy (+/- biopsies), cytology, and virology tests will be performed at the time of conization and during the follow-up period (6, 12, 24 months). HPV expression will be assessed by centralized validated marketed tests (Hybrid Capture 2, RLA genotyping, PreTect® HPV-Proofer) and by a real time PCR measuring E2, E6 and E7 viral load of HPV 1.
16180467|NCT01543035|Drug|stop statin and switch to an antiretroviral drug with less impact on lipid metabolism|Switch from a boosted PI or efavirenz based ART regimen to etravirine 400 mg/day once daily for patients in need of lipid lowering drugs (statin) after one month wash out of statin
16181064|NCT01538446|Drug|prasugrel / clopidogrel|fixed dose of prasugrel 5 mg
16180468|NCT01543022|Device|Symphony|The Symphony system has been developed for superficial implantation without the need to enter the chest. It allows for complete patient mobility and provides counter pulsation therapy for up to 30 days in hospitalized patients.
16180469|NCT01543022|Procedure|The operative approach is limited to an infraclavicular incision similar to that used for placement of a pacemaker|The vascular graft is surgically attached (anastomosed) to the subclavian artery. The symphony device is implanted into a pocket below the pectoralis muscle on the anterior chest and attached to the graft. The driveline is tunneled out through the skin and attached to the drive console.
16180470|NCT01543009|Other|Emla + Local Warming|In this arm Emla is applied 60 minutes before the procedure and then the site of venepuncture is warmed by an electric heating sand pad at the temperature of 40°C for 5 minutes before performing cannulation
16180471|NCT01542983|Behavioral|Brief behavioral treatment for insomnia and bright light|daily bright light exposure; 2 sessions for insomnia
16180472|NCT01542983|Behavioral|treatment as usual|Standard treatment for fatigue and insomnia
16180473|NCT01542970|Dietary Supplement|Placebo|Olive oil
16180474|NCT01542970|Dietary Supplement|Omega-3 fatty acids|Omega-3 PUFA treatment comprises of maternal supplementation of 3 capsules of Pikasol® (1g capsules containing 640 mg ω-3 PUFA) 2 times daily during pregnancy and lactation.
16180475|NCT01542970|Dietary Supplement|Refined coconut and peanut oil without L. reuteri|2x20 drops daily to the mother from gw 20 and from birth to the child during the first year of life
16180476|NCT01542970|Dietary Supplement|L. reuteri|The L. reuteri supplementation comprises of L. reuteri suspension 109 colony forming units (CFU) in oil (refined coconut and peanut oil) (20 droplets x 2 daily) to the mothers during pregnancy and 108 CFU (5 droplets x 1) to the children during the first years of life
16180477|NCT01542957|Behavioral|Combined Cognitive Behavioral and Dilemma-Focused Therapy|7 2-hour sessions of Group Cognitive Behavioral Therapy for Depression + 8 individual sessions of a Dilemma-Focused Intervention + 1 3-hour final group session. Manualized.
16180478|NCT01542957|Behavioral|Cognitive Behavioral Therapy for Depression|Cognitive Behavioral Therapy for Depression. Format: 7 2-hour sessions in group + 8 individual sessions + 1 3-hour final group session. Manualized.
16180479|NCT01542944|Drug|TevaGastrim|TevaGastrim 10 mg/kg SC will be administered in the evening for 4 days prior to apheresis.
16180480|NCT01542931|Drug|TPF induction chemotherapy|Docetaxel (at a dose of 75mg/m2 of body surface area) was administered as a 2-hour intravenous infusion, followed by intravenous cisplatin (75 mg/m2), administered during a period of 2 to 3 hours. After completion of the cisplatin infusion, 5-Fu (750 mg/m2/day) was administered during a period at least 8 hours for 5 days. Induction chemotherapy was given every 3 weeks for 2 cycles, unless there was disease progression, unacceptable toxic effects, or withdrawal of consent by the patient.
16180481|NCT01542918|Drug|Lenalidomide|"Formulation of Dosage forms: 5 mg, 10 mg, 15 mg and 25 mg capsules.
~Dosage: 10 mg - 30 mg (Treatment 1 and Treatment 2)
~Route of administration: Oral"
16180482|NCT01542918|Drug|Rituximab|"Formulation of Dosage forms: 100 mg/IO mL and 500 mg/50 mL solution in a single-use vial
~Dosage: 375 mg/m2, intravenous (Treatment 2, Cycle 1 only); 25 mg intraventricular injection (Treatment 2, all cycles)
~Route of administration: Intravenous (Treatment 2, Cycle 1 only); Intraventricular injection (Treatment 2, all cycles)"
16180483|NCT01542905|Dietary Supplement|Korean Red Ginseng|Korean Red Ginseng Capsule (1g/day) for 8 Weeks
16180484|NCT01542905|Other|Placebo|Placebo Capsule (1g/day) for 8 Weeks
16180485|NCT01542892|Other|Exercise Intervention|Participants will complete exercise sessions 3 times per week for 6 months. The exercise sessions will involve walking, lower extremity strength exercises, flexibility, and balance training.
16180486|NCT01542892|Dietary Supplement|Supplement Intervention|Participants will be randomly assigned to receive either the nutritional supplement or placebo. The participants will consume on beverage immediately after each exercise session.
16180487|NCT01542879|Procedure|WB-DW-MR scan|WB-DW-MR scans will be obtained on a 3T PET-MR system
16180488|NCT01542879|Procedure|18-F-FDG PET scan|
16180489|NCT01542879|Drug|Ferumoxytol|
16180490|NCT01542879|Procedure|18-F-FDG PET/MR scan|
16180491|NCT01542866|Other|Health Management Tool (HMT)|Mobile computing platform (ie HMT) which allows subjects to perform home monitoring tests
16180492|NCT01542827|Other|Biofreeze|The gel will be applied at 2.5 ml per 500 cm2 to the upper trapezius and neck muscles by a gloved technician
16180493|NCT01542827|Other|Placebo|The gel will be applied at 2.5 ml per 500 cm2 to the upper trapezius and neck muscles by a gloved technician
16180494|NCT01542814|Device|3Dimensional Mammography|The FUJIFILM 3DM examination is a 4-view mammogram which includes CC and MLO views of each breast. For each view, a routine (0-degree) mammogram will be acquired followed immediately in the same compression by a second mammogram offset at 4 degrees.
16180495|NCT01542814|Device|2D FFDM|Standard of care screening mammogram.
16180496|NCT01542801|Drug|Norfloxacin|Norfloxacin 400 mg per day
16180497|NCT01542801|Drug|ciprofloxacin|Ciprofloxacin 750 mg per week
16180498|NCT01542788|Drug|SOF|Sofosbuvir (SOF) 400 mg tablet administered orally once daily
16180499|NCT01542788|Drug|RBV|Ribavirin (RBV) was administered as a tablet orally according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg).
16180500|NCT01542788|Drug|Placebo to match SOF|Placebo to match SOF was administered orally once daily.
16180501|NCT01542788|Drug|Placebo to match RBV|Placebo to match RBV was administered orally twice daily.
16180502|NCT01542775|Behavioral|Aerobic Exercise Group|12 weeks Aerobic exercise
16180503|NCT01542775|Behavioral|Control Group|maintaining usual activities
16180504|NCT01542762|Drug|LMWH|"Each hospital will use a LMWH according to their own preferences.
~Prophylactic dosage of LMWH (for example nadroparin 2850 IE s.c.) once daily for the duration of the immobilization (average 6 weeks). If the patient's weight is more than 100kg a double dose of LMWH will be given (in case of Nadroparin 5700 IE s.c. once daily)."
16180505|NCT01542736|Drug|Carboplatin|Administered concurrently with craniospinal radiation.
16180506|NCT01542736|Drug|Vincristine|Administered concurrently with craniospinal radiation.
16180507|NCT01542736|Radiation|24 Gy|Craniospinal radiation.
16180545|NCT01542450|Drug|insulin detemir|Single dose of 0.3 U/kg administered subcutaneously (s.c. under the skin) in each treatment period separated by a washout period of 4-28 days
16180508|NCT01542723|Drug|LMWH|"Each hospital will use a LMWH according to their own preferences.
~Prophylactic dosage of LMWH (for example nadroparin 2850 IE s.c.) once daily for 8 days. If the patient's weight is more than 100kg a double dose of LMWH will be given (in case of Nadroparin 5700 IE s.c. once daily)."
16180509|NCT01542710|Drug|Ganfort|Bimatoprost/Timolol fixed combination
16180510|NCT01542710|Drug|Duotrav|Fixed combination of Travoprost and Timolol
16180511|NCT01542697|Drug|intraperitoneal nebulisation of magnesium sulphate|intraperitoneal nebulisation of 1.5 gm of magnesium sulphate with 2 ml of normal saline
16180512|NCT01542684|Drug|Azacytidine|Starting dose: 40 mg/m^2 intravenously (IV) or subcutaneously (SQ) daily for 4 days.
16180513|NCT01542684|Drug|GM-CSF|250 mcg/m^2 IV or SQ one day (the next day) after completion of azacytidine treatment, for 3 consecutive days.
16180514|NCT01542671|Behavioral|Intervention|"Lifestyle Counselor meetings at baseline, 6 months, and 12 months
~Structured eating plan
~Tailored nutritional and exercise tips. Weekly: months 1-12, biweekly: months 13-18, and monthly: months 19-24.
~Monthly Motivational phone calls with Lifestyle Counselor for the first year
~4 informational DVDs over the two year period
~Feedback on submitted food and exercise journals"
16180515|NCT01542671|Behavioral|Control|"Lifestyle Counselor meetings at baseline, 6 months, and 12 months
~Structured eating plan
~5 informational NIDDK mailings over the two year period"
16180516|NCT01542645|Drug|Methadone|Methadone (0.3 mg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
16180517|NCT01542645|Drug|Fentanyl|Fentanyl (12 mcg/kg) will be administered intraoperatively, with half of the dose given at induction of anesthesia (over 5 minutes) and the remainder administered as an infusion over the next 2 hours.
16180518|NCT01542632|Biological|Takeda's Tetravalent Dengue Vaccine Candidate (TDV)|TDV subcutaneous injection
16180519|NCT01542632|Biological|TDV New Formulation|TDV New Formulation subcutaneous injection
16180520|NCT01542632|Drug|Placebo|Placebo subcutaneous injection
16180521|NCT01542632|Drug|New Formulation Placebo|New Formulation placebo subcutaneous injection
16180522|NCT01542619|Biological|rVIIa-FP|Recombinant VIIa-FP (rVIIa-FP) is a fusion protein linking coagulation factor VIIa with albumin and will be administered by intravenous infusion in escalating doses up to 1000 mcg/kg. Participants will receive pre-treatment with an oral anticoagulant starting 7 days prior to administration of study product and continuing for 7 days after study product has been administered.
16180523|NCT01542619|Biological|Placebo (0.9% normal saline)|Placebo will be administered by intravenous infusion. Participants will receive pre-treatment with an oral anticoagulant starting 7 days prior to administration of placebo and continuing for 7 days after placebo has been administered.
16180524|NCT01542606|Device|NORMA-SENSE|The NORMA-SENSE gen 3 polymer matrix is stained by blue or green color on a pale yellow background when the pH level of the fluid in contact with it is greater than the cutoff value, and the user can consider any stain of color, which is different from the original background, as a positive result of the test.
16180525|NCT01542593|Device|Ureteral catheterization - Cook Urological Inc. open end ureteral catheter 5FR|"During a planned procedure involving ureteroscopy or ureteral stenting, after retrograde pyelography and insertion of a safety wire, ureteral catheterization will be performed using Cook Urological Inc. open end ureteral catheter 5FR for the purpose of measuring exact ureteral length.
~Measurement results will be compared to measurements performed on CT scan (obtained before surgery)."
16180526|NCT01542580|Device|Vanguard SSK 360 with PS Bearing|non-constrained tibial bearing
16180527|NCT01542580|Device|Vanguard SSK 360 with PSC bearing|constrained tibial bearing
16180528|NCT01542580|Device|Vanguard DA 360|Dual-articulation device, only cleared in EU
16180529|NCT01542580|Device|Vanguard 360 TiNbN Femur with PS bearing|non-constrained tibial bearing, titanium niobium nitride coated Vanguard 360 femur
16180530|NCT01542580|Device|Vanguard 360 TiNbN Femur with PSC bearing|constrained tibial bearing, titanium niobium nitride coated Vanguard 360 femur
16180531|NCT01542567|Drug|Abitren|SUPPOSITORIES 50 Mg 2 SUPPOSITORIES A WEEK
16180532|NCT01542567|Drug|Placebo|Placebo suppositories
16180533|NCT01542554|Other|Low glycaemic index diet|Diabetic subjects will be given dietary advice with emphasis on low glycaemic index diet
16180534|NCT01542554|Other|Usual diabetic diet|Diabetic subjects will be given dietary advice without mention about glycaemic index
16180535|NCT01542541|Drug|Rifaximin|550mg BID for 2 days
16180536|NCT01542528|Behavioral|IBBS|Combination of computer-presented brain exercises with a physical education curriculum designed to enhance sustained attention, inhibitory control and other executive capacities. Groups of 10 students incorporating the Good Behavior Game. Two-hour sessions four days a week: classroom with computers (45-60 mins) plus sports activities in the gymnasium (45-60 mins) extending over a total 15 weeks (60 sessions).
16180537|NCT01542515|Procedure|Meniscal allograft arthroplasty of the carpometacarpal joint of the thumb|"The surgical procedure will involve the use of human meniscal allograft tissue that will be provided by industry. The meniscus will be contoured into a T shape. The T-shaped meniscus allograft is then inserted into the arthritic thumb CMC joint and secured with two suture anchors."
16180538|NCT01542502|Drug|Anakinra|Anakinra 100 mg daily subcutaneous injection
16180539|NCT01542502|Drug|Placebo|Placebo daily subcutaneous injection
16180540|NCT01542489|Drug|insulin detemir|Prescribed by the physician solely as a result of a normal clinical evaluation. The physician determines the starting dose and frequency, as well as later changes to either dose or frequency, if any
16180541|NCT01542489|Drug|insulin aspart|Prescribed by the physician solely as a result of a normal clinical evaluation. The physician determines the starting dose and frequency, as well as later changes to either dose or frequency, if any
16180542|NCT01542489|Drug|human soluble insulin|Prescribed by the physician solely as a result of a normal clinical evaluation. The physician determines the starting dose and frequency, as well as later changes to either dose or frequency, if any
16180543|NCT01542476|Drug|insulin detemir|Prescribed by the physician solely as a result of a normal clinical evaluation. The physician determines the starting dose and frequency, as well as later changes to either dose or frequency, if any
16180544|NCT01542463|Drug|insulin detemir|Prescribed at the discretion of the physician
16181267|NCT01536873|Drug|Dolutegravir|Eligible patients will receive DTG 50 mg given orally BID
16180546|NCT01542450|Drug|insulin NPH|Single dose of 0.3 U/kg administered subcutaneously (s.c. under the skin) in each treatment period separated by a washout period of 4-28 days
16180547|NCT01542437|Drug|BIBW 2992|"All patients will receive: BIBW 2992 40mg every 24 hours orally, where a cycle corresponds to complete this treatment for 28 days; option 30mg/day dose reductions, according to established criteria.
~Not to be compared with any other drug."
16180548|NCT01542424|Drug|biphasic insulin aspart 30|Prescribed at the discretion of the physician
16180549|NCT01542424|Drug|insulin detemir|Prescribed at the discretion of the physician
16180550|NCT01542398|Behavioral|Family-Focused, Community-Based, Resilience-Targetting Psychosocial Intervention|A 12-module manualised intervention focusing on reducing psychological distress, improving family and community functioning and boosting daily functioning of adolescents through the use of Mobile Cinema Screenings and task-based, participatory, group-sessions
16180551|NCT01542385|Procedure|Stent|Percutaneous coronary intervention: reperfusion with a thrombectomy catheter or a small balloon angioplasty catheter, followed by coronary stenting
16180552|NCT01542372|Drug|Medication augmentation|
16180553|NCT01542372|Behavioral|CBT|
16180554|NCT01542359|Other|Yogic practice|breathing, meditation, physical postures
16180555|NCT01542359|Other|Conventional Exercise|Standard physical exercises such as toe touch in standing, curl ups, push ups, leg lifts
16180556|NCT01542346|Procedure|subcutaneous adaption|
16180557|NCT01542333|Genetic|gene expression analysis|
16180558|NCT01542333|Genetic|proteomic profiling|
16180559|NCT01542333|Genetic|reverse transcriptase-polymerase chain reaction|
16180560|NCT01542333|Genetic|western blotting|
16180561|NCT01542333|Other|immunohistochemistry staining method|
16180562|NCT01542333|Other|laboratory biomarker analysis|
16180563|NCT01542333|Procedure|spectroscopy|
16180564|NCT01542320|Dietary Supplement|Lactobacillus reuteri DSM 17938|1 x 10e8 colony forming units in 5 drops (0.17ml)daily from study enrollment to study conclusion. Duration based on rotavirus vaccine administration.
16180565|NCT01542320|Other|Placebo|Solution without active Lactobacillus reuteri
16180566|NCT01542307|Biological|Oxygen|Oxygen is inhaled for 30 minutes during migraine attack
16180567|NCT01542307|Biological|Room air|Placebo
16180568|NCT01542294|Drug|s1|60-90mg/m2/d P.O. day 1-14, repeated every 21 days
16180569|NCT01542294|Drug|Oxaliplatin|130mg/m2 d1 repeated every 21 days
16180570|NCT01542281|Dietary Supplement|Whey protein and dietary supplements|Whey protein and dietary supplements in addition to pre-hab exercise
16180571|NCT01542281|Other|prehab exercise|minimum 4 weeks and maximum 8 weeks; 3 times a week
16180572|NCT01542268|Drug|pentoxifylline|Patients will take 800mg/day, via oral, of pentoxifylline. 400 mg of pentoxifylline each 12 hours (during meals time).Period: 3 months.
16180573|NCT01542268|Drug|pentoxifylline placebo|Patients will take 800mg/day, via oral, of pentoxifylline placebo. 400 mg of pentoxifylline placebo each 12 hours (during meals time).Period: 3 months.
16180574|NCT01542255|Drug|vinblastine|1 mg/m2 vinblastine given three times per week administered intravenously.
16180575|NCT01542255|Drug|Cyclophosphamide|60 mg/m2 cyclophosphamide taken orally every day for 3 weeks with one week rest
16180576|NCT01542255|Drug|dacarbazine|15 mg/m2 dacarbazine given three times per week for 3 weeks with 1 week rest
16180577|NCT01542242|Drug|Liraglutide|Liraglutide 0.6 mg SQ daily for one week, increase to a maximum dose of 1.8 mg SQ daily by 6 weeks, and subsequent continuation for the remainder of a year.
16180578|NCT01542229|Behavioral|Prolonged Exposure for PTSD (PE) + Treatment as Usual (TAU)|12 weekly sessions of Prolonged Exposure in addition to Treatment As Usual
16180579|NCT01542229|Behavioral|Treatment As Usual (TAU)|Treatment as usual (TAU) will receive support services through the VA potentially inclusive of case management, psychotropic medication management, and/or supportive counseling
16180580|NCT01542216|Behavioral|Nutrition and Exercise Group|Patients randomized to this arm will receive nutrition and exercise consultations. Exercise consultations will home- and institution-based.
16180581|NCT01542216|Behavioral|Yoga and Stretching Group|Patients randomized to this arm will receive consultations on yoga and stretching exercises.
16180582|NCT01542190|Drug|Ketorolac Tromethamine|ketorolac tromethamine 0.4%
16180583|NCT01542151|Other|Time of labor induction|Assigned time of labor induction - morning or evening
16180584|NCT01542138|Drug|Desonide|Once-a-day applying on axillar hyperpigmentation for 9 weeks
16180585|NCT01542138|Drug|Niacinamide|Once-a-day applying on axillar hyperpigmentation for 9 weeks
16180586|NCT01542138|Drug|Placebo|Humectant placebo cream
16180587|NCT01542125|Drug|Liposomal Lidocaine|4% Liposomal Lidocaine
16180588|NCT01542125|Drug|Placebo|Tubes were visually identical to the Liposomal Lidocaine tubes.
16180589|NCT01542112|Other|PSactive model|"The model is designed to address the main issues that lie at the core of initiatives to manage patient expectations and improve patient satisfaction. It is a structured interventional set of activities, which gives the clinician an opportunity to meet patient expectations and improve patient satisfaction.
~The interventional model is comprised of teachable-learnable interpersonal communicative steps occurring between the clinician and the patient which are: Gather information on the patient's expectations and perception of the hospitalization, respond, provide relevant information and document the intervention."
16180590|NCT01542112|Other|No treatment|Patients in this arm receive the usual routine in the department.
16180591|NCT01542099|Drug|Remifentanil|"According to previous patient's response, the investigators will allocate the effect site concentration of remifentanil of next patient during double lumen tube intubation. For this allocation of dose of remifentanil the investigators use up-and-down method.
~For the first patient, the dose of remifentanil would be fixed at 6.0 ng/ml which we predict as EC50. And, step size of dose is 0.5ng/ml."
16180592|NCT01542099|Drug|Remifentanil|"According to previous patient's response, the investigators will allocate the effect site concentration of remifentanil of next patient during single lumen tube intubation. For this allocation of dose of remifentanil the investigators use up-and-down method.
~For the first patient, the dose of remifentanil would be fixed at 6.0 ng/ml which we predict as EC50. Step size of dose is 0.5ng/ml."
16180593|NCT01542086|Procedure|Myocardial SPECT|
16180594|NCT01542086|Procedure|64-channel coronary CT angiography (CCTA)|
16180595|NCT01542073|Drug|68Ga-BNOTA-PRGD2|Intravenous injection of one dosage of 111 MBq 68Ga-BNOTA-PRGD2. Tracer doses of 68Ga-BNOTA-PRGD2 will be used to image angiogenesis of myocardial infarction area by positron emission tomography / computed tomography (PET/CT)
16180596|NCT01542060|Drug|biphasic insulin aspart 30|Administered via an insulin injection device. Dosages varied according to individual patients' medical requirement as determined by their attending clinician
16180597|NCT01542047|Drug|Carboplatin|Carboplatin will be administered intravenously over approximately 30 minutes on day 1 of each cycle. The dosage used will be 5 AUC for the first 5 cycles, and will be increased to 6 AUC for the sixth cycle.
16180598|NCT01542047|Drug|Pazopanib|Pazopanib will be administered orally at 200 to 800 mg/kg2. It will be given either on days 1 through 21 of each 3-week cycle, or if needed, it will be given on days 3 through 19.
16180599|NCT01542034|Drug|Deoxycholic acid injection|Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
16180600|NCT01542034|Drug|Placebo|Phosphate buffered saline placebo for injection
16180601|NCT01542021|Drug|degarelix injection|Treatment will consist of a single 240 mg injection of degarelix 4 ± 1 day before radical prostatectomy, depending on treatment arm.
16180602|NCT01542021|Drug|degarelix injection|Treatment will consist of a single 240 mg injection of degarelix 7 ± 1 day before radical prostatectomy, depending on treatment arm.
16180603|NCT01542021|Drug|androgen deprivation therapy|
16180604|NCT01542008|Behavioral|Customized Adherence Enhancement (CAE)|CAE consists of the application of a series of up to four psychosocial treatment modules based upon a baseline evaluation of adherence vulnerabilities/needs. The standardized modules (Psychoeducation, Modified Motivational Enhancement Therapy, Communication with Providers, Medication Routines), are assigned based upon pre-established criteria designed to fit the needs of the patient.
16180605|NCT01542008|Behavioral|broadly-directed, non-individualized education (EDU)|"EDU will consist of 4 core in-person sessions using the patient work-book from the NIMH funded study, Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD), and following the general educational format of the Collaborative Care control intervention in the STEP study. EDU addresses BD treatment broadly, including diagnosis and management, and the sessions will review the materials and allow time for questions as needed."
16180606|NCT01541969|Device|CR Neuromodulation|"Ear level device which delivers patterned sound stimulation.
~The experimental arm will use the device fitted according to audiologist training given by the manufacturer/funder. An individually specified sound stimulation algorithm is hypothesised to interrupt tinnitus generating activity in the brain. For the first 12 weeks participants will be asked to wear the device every day for 6 hours, and in blocks of time not less than 1 hour. After 12 weeks participants will be unblinded and continue with the same experimental intervention. In weeks 13-36 participants will be asked to wear the device every day for 4 hours, in continuous blocks of at least 1 hour."
16180607|NCT01541969|Device|Tinnitus masking|The active comparator uses the same ear level device and also delivers patterned sound but the stimulus will be determined according to an algorithm predicted not to break up tinnitus generating activity in the brain. It may have a masking effect. For the first 12 weeks participants will be asked to wear the device every day for 6 hours, and in blocks of time not less than 1 hour. After 12 weeks, the participants will be unblinded and the device algorithm will be reprogrammed in the same way as the experimental intervention. In weeks 13-24 participants will be asked to wear the device for 6 hours per day, in continuous blocks of at least 1 hour. In weeks 25-36 they will be asked to continue using the device every day for 4 hours, in continuous blocks of at least 1 hour.
16180608|NCT01541956|Drug|Metformin|500 mg twice daily
16180609|NCT01541956|Drug|vildagliptin|Vildagliptin 50 mg twice daily
16180610|NCT01541943|Drug|Atorvastatin|Once daily, administered orally, 8 week
16180611|NCT01541943|Drug|Losartan|Once daily, administered orally, 8 week
16180612|NCT01541943|Drug|Placebo|Once daily, administered orally, 8 week
16180613|NCT01541943|Drug|HL-040XC|Once daily, administered orally, 8 week
16180614|NCT01541930|Drug|GK567|Once or twice daily, for 14 days, up to 30 g per day
16180615|NCT01541917|Behavioral|Web-based coping skills training|This intervention comprises a 12-week interactive, multi-component, multimedia online training that consists of instruction in specific self-management strategies, disease education, and social support. The content is rooted in cognitive-behavioral principles of disease self-management. In addition to the web-based modules, the intervention consists of monthly telephone support for 3 months by a trained bilingual health coach (research nurse) to review material and help enhance motivation.
16180616|NCT01541917|Behavioral|Online disease education|"The online disease education intervention provides access to an online resource center containing links to 12 educational websites about Juvenile Idiopathic Arthritis. Participants will be asked to review one educational website per week over the course of 12 weeks. Participants also will receive three monthly phone calls by a bilingual nurse health coach to discuss the participant's efforts at managing his/her disease."
16180617|NCT01541904|Drug|PRO-118 Ophthalmic Solution 0.015%|PRO-118 Ophthalmic Solution 0.015 % applied qd during 21 days
16180618|NCT01541904|Drug|PRO-118 Ophthalmic Solution 0.015 %|PRO-118 Ophthalmic Solution 0.015 % applied twice to day during 21 days
16180619|NCT01541904|Drug|PRO-118 Ophthalmic Solution 0.020 %|PRO-118 Ophthalmic Solution 0.020 % applied qd during 21 days
16180620|NCT01541904|Drug|PRO-118 Ophthalmic Solution 0.020 %|PRO-118 Ophthalmic Solution 0.020 % applied twice to day during 21 days
16180621|NCT01541904|Drug|Placebo Ophthalmic Solution|Placebo Ophthalmic Solution applied qd during 21 days
16180622|NCT01541891|Drug|PRO-148 Ophthalmic Solution|PRO-148 Ophthalmic Solution applied four times per day (c/6 hours) during 60 days.
16180623|NCT01541891|Drug|Active Comparator: SYSTANE ® Ophthalmic Solution|Sterile solution containing polyethylene glycol 400, propylene glycol, hydroxypropyl-guar, boric acid, calcium chloride, magnesium chloride, potassium chloride, sodium chloride, zinc chloride and polyquad (polidronium chloride) 0,001%. four times per day (c/6 hours) during 60 days.
16180624|NCT01541865|Device|Renal Denervation|percutaneous renal denervation using the Vessix RF balloon catheter
16180625|NCT01541852|Drug|Losmapimod|One tablet of Losmapimod 7.5mg twice daily
16180626|NCT01541852|Drug|Placebo|One tablet twice daily
16180627|NCT01541839|Device|Septal Stapler|This device is a stapler designed to place resorbable implants into the nasal septum. Each device contains 8 staples.
16180629|NCT01541826|Dietary Supplement|Placebo capsule|Color-matched rice powder pill, 2 x 250 mg/day for 12 weeks
16180630|NCT01541826|Dietary Supplement|Chokeberry extract capsule, acute|Chokeberry extract capsule, 2 x 250 mg, one-time dose.
16180631|NCT01541774|Device|Phoenix Atherectomy System|Evaluate the procedural safety and effectiveness of the Phoenix Atherectomy™ System for the treatment of de novo and restenotic atherosclerotic lesions located in native peripheral arteries as assessed through 30 day follow-up. Further evaluations of device performance ensuring no prostenotic response as assessed through six month follow-up.
16180632|NCT01541761|Behavioral|Family groups|The group sessions are designed to facilitate on-going interaction among consistent groups of 6 - 8 parents and other care givers with infants the same age and will be coordinated with scheduled well child care visits. They will be conducted in English and Spanish. The groups will focus on nutrition and, parenting.
16180633|NCT01541748|Other|Axis|Coloplast's Axis™ Allograft Dermis is used for anterior, posterior or combined (anterior and posterior) pelvic organ prolapse repair.
16180634|NCT01541735|Drug|Pantoprazole|The pantoprazole will be administered in capsules of 40mg. The dose will be 1 capsule per day during 45 days.
16180635|NCT01541735|Drug|placebo|Placebo 40 mg dose.
16180636|NCT01541709|Drug|imatinib|The patients will receive 400 mg per day of imatinib for 4 weeks, and then 600mg per day (300 mg po bid) for 4 weeks if tolerable to 400 mg per day, and then 800 mg per day (400 mg po bid)
16180637|NCT01541683|Other|PEG solution (Fortrans®) and Mentholyptus Drops (Halls®)|Patients will be instructed to drink 4 Liters of PEG solution (FORTRANS®) split into 2 days while sucking on sugar-free mentholyptus drops (2 L at 7-9 pm on the day prior to the colonoscopy while continuously sucking on Halls®, and 2 L on the day of the colonoscopy to be completed a minimum of 1.5 hours before the procedure while continuously sucking on Halls®)
16180638|NCT01541683|Other|PEG solution (Fortrans®)|4 liters of PEG solution (FORTRANS®) split into 2 days (2 L at 7-9 pm on the day prior to the colonoscopy, and 2 L on the day of the colonoscopy to be completed a minimum of 1.5 hours before the procedure)
16180639|NCT01541670|Drug|Anti-Macrophage Migration Inhibitory Factor (Anti-MIF) Antibody|Intravenous injection
16180640|NCT01541657|Other|Ankle Joint Mobilization|The posterior ankle mobilization treatment is a manual therapy technique that consists of gently gliding your ankle in the backward direction through a pain free range of motion. This is a common therapy technique used by athletic trainers for the treatment of ankle sprains. The objective of this therapy technique is to glide the ankle into the area which restricts range of motion and gently stretch the restricted area. To begin this treatment, a certified athletic trainer with experience in applying this therapy technique will provide mild traction to the ankle joint to lightly distract the bones of the ankle joint. The athletic trainer will then apply two sets of joint mobilizations which will each last 2 minutes. Each repetition will consist of gently gliding the ankle joint in the backward direction until an area of restriction is reached. The athletic trainer will push into the restriction and then glide the ankle back to the starting position.
16180641|NCT01541657|Other|Foot Massage|The foot massage treatment is a manual therapy technique that consists of gently rubbing the bottom of your feet with both hands like kneading dough. To begin the treatment, you will be asked to lie comfortably on a treatment table you're your feet hanging slightly off the edge. The athletic trainer with experience in applying this therapy will place his hands on the bottom of your foot and begin to massage your feet from your toes down to your heel. The athletic trainer will perform 2 sets of 2 minutes of massage with 1 minute rest in between sets.
16180642|NCT01541657|Other|Calf Stretching|The calf stretching treatment is a technique that is commonly used in sports and rehabilitation. You will be asked to place your foot on a slant board located next to a wall with your heel positioned below your toes on the slant board. You will be asked to lean towards the wall until you feel tension in your calf muscles that feels like a good stretch. You will perform 2 sets of 3 stretches that are held for 30 seconds each. Between each stretch, you will rest for 10 seconds. Between each set, you will rest for 1 minute.
16180643|NCT01541644|Device|Acupuncture|Participants will receive acupuncture treatment twice weekly for 2 weeks, then once per week for 4 weeks, and then biweekly for 4 weeks.
16180644|NCT01541631|Drug|Praziquantel and Albendazole|Praziquantel Tablet - 40mg/kgBWT given once Albendazole Tablet - 400mg once
16180645|NCT01541631|Drug|Praziquantel and Albendazole|Praziquantel- 40mg/kgBWT Albendazole - 400mg once
16180646|NCT01541631|Drug|Praziquantel and Albendazole|Praziquantel- 40MG/KG ONCE Albendazole - 400mg once
16180647|NCT01541618|Other|MSDX Complex-1 Biomarker test|MSDX Complex-1 Biomarker test
16180648|NCT01541605|Drug|methylphenidate|tablets for oral use
16180649|NCT01541605|Drug|Placebo|tablets for oral use
16180650|NCT01541592|Other|Dietary fat|On the study day, each participant will receive 100 grams of a randomly assigned fat via a nasoduodenal tube. The oil will be infused at a rate of ~1 tablespoon per hour so that the total infusion time will be 6 hours.
16180651|NCT01541579|Other|Cx601|120 million cells administered by intralesional injection.
16180652|NCT01541579|Other|Saline solution|24 mL saline solution by intralesional injection
16180653|NCT01541553|Procedure|Cryotherapy|"Cryotherapy of all visible AKs (4-8 lesions, baseline lesions) in the selected treatment area"
16180654|NCT01541553|Drug|Vehicle|Field treatment with vehicle gel once daily for 3 consecutive days.
16180655|NCT01541553|Drug|Ingenol metabute|Field treatment with vehicle gel once daily for 3 consecutive days.
16180656|NCT01541540|Behavioral|e-Counseling plus Usual Care|28 emails will be sent proactively over a 12-month period. Emails will be sent weekly for the first 4 months, biweekly from months 5 to 8, and monthly from months 9 to 12. Each email will contain an e-link to lifestyle counseling activities designed to enhance motivation and skill to initiate and maintain lifestyle change. e-Counseling includes video-based education and counseling as well as e-tools to self-monitor and reinforce adherence to self-management behavior for exercise, diet, prescribed medications and smoke-free living.
16180657|NCT01541540|Behavioral|Control|The control group will receive general educational material on heart healthy living. 28 emails will be sent proactively over a 12-month period. Emails will be sent weekly for the first 4 months, biweekly from months 5 to 8, and monthly from months 9 to 12.
16180658|NCT01541527|Biological|blood test|One blood test entering in the usual follow-up of the patient
16180725|NCT01540877|Procedure|Application of local anesthetics (EMLA plaster)|topical application of EMLA on the volar forearm
16180659|NCT01541501|Device|Pachymetry|Healthy volunteers recruited among subject that underwent a routine ophthalmologic evaluation or among both students and workers at our clinic, will be submitted to CCT measurement through four different instruments: Scheimpflug camera tomography, SD-OCT, anterior chamber SD-OCT, and finally with US pachymeter.
16180660|NCT01541488|Drug|BI 1021958|tablet
16180661|NCT01541488|Drug|BI 1021958|drinking solution / tablet
16180662|NCT01541488|Drug|Placebo to BI 1021958|SRD part: oral administration in fasted state, FE part: oral administration in fasted state and after standard high fat breakfast
16180663|NCT01541475|Drug|Bupropion, Escitalopram|Week 0-1: Escitalopram 10mg, Bupropion 150mg Week 2-3: Escitalopram 10mg, Bupropion 300mg Week 4-8: Escitalopram 20mg, Bupropion 300mg
16180664|NCT01541475|Drug|Escitalopram|Week 0-3: Escitalopram 10mg Week 4-8: Escitalopram 20mg
16180665|NCT01541462|Other|Weaning|Decrease assistance provided by the ventilator
16180666|NCT01541436|Device|Remote Ischemic Preconditioning, Capsaicin, UV-B|The participants will have one disposable tourniquet applied to the left mid thigh by research personnel. The participants will then be randomized to the treatment group or sham group. The treatment group will receive 3 cycles of RIPC to the left lower leg by occluding blood flow at the thigh with a pneumatic cuff. Each cycle will consist of 5 minutes of ischemia by inflating the cuff to 300 mmHg followed by 5 minutes of reperfusion. The sham group will have the cuff inflated to no more than 15mmHg for three cycles as described above. Areas of hypersensitivity and allodynia will be obtained every 40 min for 280 min following the end of capsaicin application.
16180667|NCT01541410|Device|Vascutek Hybrid Graft|Single Group Assignment
16180668|NCT01541397|Drug|Sapropterin|20 mg/kg, orally, daily, 1 year or patient chooses to discontinue therapy
16180669|NCT01541384|Device|Vitality GlowCaps|"The main research instrument is an electronic pill bottle called GlowCaps that has the ability to transmit reminder messages via email, text, and phone to the subject, and adherence data to special servers. The messages will be sent twice a day, if a subject misses a dose of their immunosuppression medication (tacrolimus). Each time the pill bottle is opened (or not opened), a date- and time-stamped wireless signal is sent to the Vitality server via the AT&T cellular network. No extra cellular or wireless service is required from subjects for the GlowCap to function.
~Note: GlowCaps are a Class 1 Medical Device registered with the FDA. Because of this Class 1 designation, they are not subject to FDA testing or approval."
16180670|NCT01541371|Drug|Paliperidone ER|Paliperidone Extended Release (ER) 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral (by mouth) tablets depending on Investigator's discretion once daily for 12 weeks.
16180671|NCT01541358|Radiation|fluorine F 18 sodium fluoride|Undergo fluorine F 18 sodium fluoride PET/CT scan
16180672|NCT01541358|Procedure|positron emission tomography/computed tomography|Undergo fluorine F 18 sodium fluoride PET/CT scan
16180673|NCT01541345|Device|Autogenous bone graft|Bone augmentation will be performed using autogenous bone from the retromolar or chin area followed by a fixation with titanium screws at the recipients site; filled with deproteinized bovine bone mineral (DBBM) particles (Bio-Oss®, Geistlich Pharma AG, Wolhusen, Switzerland) and covered with a collagen membrane (Bio-Gide®, Geistlich Pharma AG, Switzerland)
16180674|NCT01541345|Drug|InductOs|CE-marked medical device Bio-Oss Spongiosa Block® (xenogenic bone) loaded with InductOs® (1.5 mg Dibotermin alfa / ml) covered with Bio-Gide® (collagen membrane). One time application at augmentation surgery.
16180675|NCT01541345|Procedure|Augmentation surgery|CE-marked medical device Bio-Oss Spongiosa Block® (xenogenic bone) loaded with InductOs® (1.5 mg Dibotermin alfa / ml) covered with Bio-Gide® (collagen membrane)
16180676|NCT01541332|Drug|Pomalidomide|Pomalidomide administered to 3 cohorts of subjects at escalating doses of 2 (cohort 1), 3 (cohort 2) and 4 mg/dose (cohort 3) per orem (PO). Doses are to be administered once-a-day, for the first 21 days, as part of a 28-day treatment cycle, followed by a 7-day rest period.
16180677|NCT01541332|Drug|Pegylated Liposomal Doxorubicin (PLD)|"Dexamethasone will be given at a dose of 40 mg/dose IV. Doses are to be administered on days 1, 4, 8, and 11 of the 28-day cycle.
~PLD will be given at a dose of 5.0 mg/m2 as a 60 minute IV infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle."
16180678|NCT01541332|Drug|Dexamethasone|Dexamethasone will be given at a dose of 40 mg/dose IV. Doses are to be administered on days 1, 4, 8, and 11 of the 28-day cycle.
16180679|NCT01541293|Drug|Lidocaine|100mg of liquid lidocaine, single dose, instilled into the uterine cavity via a flexible trans-cervical catheter immediately prior to laminaria insertion.
16180680|NCT01541293|Drug|Normal Saline|5mL of normal saline, instilled into the uterus via a flexible trans-cervical catheter immediately prior to laminaria insertion.
16180681|NCT01541280|Drug|Azacitidine|Azacitidine (AZA) is to be administered every 28 days beginning day +56 to 100 posttransplant for one year provided the patients has a platelet count of >15 x 109/L without transfusion for at least 2 successive days, and an absolute neutrophil count of >1 x 109/L without growth factor for at least 2 successive days, and no acute GVHD greater than grade I and no clinical evidence of life-threatening infection. AZA is given 32 mg /m²/day subcutaneously for 5 days every 28 days (
16180682|NCT01541280|Other|DLI|"Donor lymphocyte infusion (DLI) is to be given from day +126 (week 18) in patients without immunosuppressive therapy for at least one month and following 3 cycles of AZA, and without clinical signs of GVHD, and without uncontrolled infection and without a recent history of >grade 2 acute GVHD. DLI are schedules every 8 weeks. There are 3 DLI scheduled.
~If first cycle of AZA is postponed beyond day 56 (maximum to Day 100), all subsequent cycles and DLI will be post poned too."
16180683|NCT01541267|Drug|aliskiren, eplerenon, telmisartan|aliskiren (Rasilez 300 mg, Novartis Europharm eplerenon (Inspra 50 mg, Pfizer Europe) telmisartan (Micardis 80 mg, Boehringer Ingelheim)
16180684|NCT01541254|Device|Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)|Low profile Visualized Intraluminal Device (LVIS and LVIS Jr.)
16180721|NCT01540916|Other|Decrease minute ventilation|Respiratory rate will be decrease in order to have a 30% decrease of minute ventilation
16180722|NCT01540903|Biological|PfSPZ Challenge|Aseptic, purified, vialed, cryopreserved, fully infectious NF54 Plasmodium falciparum sporozoites (PfSPZ Challenge)
16180723|NCT01540903|Biological|Saline|Saline
16180724|NCT01540877|Procedure|Application of capsaicin 0.6%|topical application of 0.6% capsaicin on the volar forearm
16187756|NCT01488877|Drug|Spironolactone|spironolactone 25 mg once daily
16180685|NCT01541228|Device|Photodynamic therapy with light dose of 70 J/cm2 using a broad-band red light source|"Patients take part in intraindividual (left-right) comparison study when having at least 2 non-hyperkeratotic actinic keratoses (AK) on the left and right sides of the face/scalp.
~Punch biopsies in 3.5 millimetres diameter performed to confirm the diagnosis of AK.
~Patients randomized so that half of them would receive a light dose of 70J/cm2 as their first split face/scalp treatment on the left side. Photodynamic therapy with the light dose of 70 J/cm2 using a broad-band red light source (570-670 nm,Curelight®, PhotoCure, Oslo, Norway) and 20% 5-ALA. Treatment repeated twice with two weeks interval."
16180686|NCT01541228|Procedure|Photodynamic therapy with 100J/cm2 light dose using a broad-band red light source|"Patients take part in intraindividual (left-right) comparison study when having at least 2 non-hyperkeratotic actinic keratoses (AK) on the left and right sides of the face/scalp. Punch biopsies in 3.5 millimetres diameter performed to confirm the diagnosis of AK.
~Patients randomized so that half of them would receive a light dose of 100J/cm2 as their first split face/scalp treatment on the left side. Photodynamic therapy with the light dose of 70 J/cm2 using a broad-band red light source (570-670 nm,Curelight®, PhotoCure, Oslo, Norway) and 20% 5-ALA.Treatment repeated twice with two weeks interval."
16180687|NCT01541215|Drug|liraglutide|Administered subcutaneously (s.c., under the skin) once daily.1.8 mg or maximum tolerated dose (MTD: 0.6 mg, 1.2 mg, 1.8 mg) for 26 weeks. Subjects will continue treatment in a 26 week open-labelled extension. Rescue treatment will be allowed if rescue criteria are met.
16180688|NCT01541215|Drug|placebo|Administered subcutaneously (s.c., under the skin) once daily for 26 weeks. Subjects will discontinue placebo treatment in the open-labelled extension. Rescue treatment will be allowed if rescue criteria are met.
16180689|NCT01541215|Drug|metformin|Tablets administered for 26 weeks. Maximum tolerated dose (MTD) between 1000-2000 mg at the discretion of the investigator. Subjects will continue treatment in a 26 week open-labelled extension.
16180690|NCT01541202|Drug|rhNRG-1|10 hours per day i.v drip for the first 10 days (0.6ug/kg/day), followed by weekly 10 minutes i.v bolus (0.8ug/kg/day), from the 3rd week for 23 weeks
16180691|NCT01541202|Drug|Placebo|10 hours per day i.v drip for the first 10 days (0ug/kg/day), followed by weekly 10 minutes i.v bolus (0ug/kg/day), from the 3rd week for 23 weeks
16180692|NCT01541189|Drug|Valsartan|80 mg/day for 2 weeks, up-titrated to 160 mg/day for further 8 weeks
16180693|NCT01541176|Other|Absence of corticotherapy post-transplantation|No study treatment
16180694|NCT01541176|Drug|Corticotherapy post-transplantation|"Prednisone or prednisolone orally for at least one year post-transplantation with the following minimal doses :
~D1 to D14 : 20 mg/day,
~D15 to M1 : 15 mg/day,
~M1 to M3 : 10 mg/day,
~M3 to M12 : 5 mg/day."
16180695|NCT01541150|Behavioral|neuropsychological questionnaires|Due to this study population (inmates), the investigators have decided to classify the protocol as and interventionnal study.
16180696|NCT01541137|Drug|Diclofenac|oral diclofenac 75 mg, a 44-hour iv-infusion of diclofenac 150 mg/24h, oral diclofenac 75 mg x 2, IV-PCA programmed with morphine boluses of 2-3 mg and a lock-out time of 5-15 minutes
16180697|NCT01541137|Drug|parecoxib/ valdecoxib|oral valdecoxib 40 mg, a 44-hour iv-infusion of parecoxib 80 mg/24h, IV-PCA programmed with morphine boluses of 2-3 mg and a lock-out time of 5-15 minutes
16180698|NCT01541137|Device|patient controlled epidural analgesia|epidural catheter, epidural loading dose of 1 ml/10 kg of 0.15% bupivacaine with fentanyl 6 µg/ml. Thereafter a continuous infusion was started at 1 ml/10 kg/h. In the PACU PCEA-patients could take incremental doses of 3 ml with a 8-15 min lock-out time
16180699|NCT01541124|Drug|Opioid|10 mg/pill, po, each 6h, during 6m
16180700|NCT01541111|Drug|Magnesiun|75mg pills; each 12h; 12wk
16180701|NCT01541098|Biological|Lyophilized Plasma|Licensed plasma that has been lyophilized.
16180702|NCT01541098|Biological|Licensed Plasma|Plasma that has been authorized for transfusion.
16180703|NCT01541085|Drug|Darunavir/Ritonavir (DRV/r)|Darunavir/Ritonavir (DRV/r) + Tenofovir/Emtricitabina regimen
16180704|NCT01541085|Drug|Efavirenz (EFV)|Efavirenz (EFV) + Tenofovir/Emtricitabina regimen
16180705|NCT01541072|Drug|Pegfilgrastim|Pegfilgrastim (Neulasta®, AMGEN Laboratories): single subcutaneous administration of Pegfilgrastim, 6 mg at day 5 (D5) after autologous stem cell transplantation
16180706|NCT01541072|Drug|Filgrastim|Filgrastim (Neupogen®, AMGEN Laboratories): daily subcutaneous administration, 5µg/kg/day from day 5 (D5) after autologous stem cell transplantation until recovery from aplasia (Neutrophils >= 0.5 G/L)
16180707|NCT01541059|Drug|Placebo injection|Injection of saline solution into the vestibular capsule of each tooth to be extracted.
16180708|NCT01541059|Drug|Ropivacaine injection|Ropivacaine is injected into the vestibular capsule of each tooth to be extracted.
16180709|NCT01541046|Biological|Biogaia L. reuteri DSM 17938|Freeze-dried Lactobacillus reuteri DSM 17938 suspended in oil. Brand Name Active Agent: BioGaia™
16180710|NCT01541046|Biological|Probiotic Placebo|Description of Placebo: contains same excipients as Active Agent, without the active ingredient
16180711|NCT01541007|Drug|Cabazitaxel|25 mg/m2 every three weeks
16180712|NCT01541007|Drug|weekly cabazitaxel|10 mg/m2 dag 1,8,15,22. Cycle length is 6 weeks
16180713|NCT01540994|Radiation|radiation therapy|Stereotactic Body Radiation Therapy
16180714|NCT01540981|Device|MIST Therapy|FDA cleared non-contact ultrasound device. Delivers low frequency ultrasound via a fine saline to the wound area.
16180715|NCT01540981|Other|Standard of Care|Standard of Care consists of pressure relief, wound cleansing and dressing as needed
16180716|NCT01540968|Behavioral|Nutrition & physical exercise|Patients will be randomly assigned to intensive individual nutritional counselling including oral nutritional supplements and a specifically designed exercise program combining strength and balance training.
16180717|NCT01540955|Behavioral|Improving Cognition with group intervention|Participants attend 5 weekly group sessions that are 2 hours each, delivered by a trained therapist. Sessions focus on specific aspects of attention, memory, multi-tasking and encoding. Homework assignments are practiced between classes. Goals are set for improved functioning.
16180718|NCT01540942|Dietary Supplement|nutrition treat|intestinal nutrition treat :female：REE（Kcal/d）=655+9.6W+1.7H-4.7A; male：REE（Kcal/d）=66+13.7W+5.0H-6.8A;[W=weight（Kg）；H=height（cm）；A=age（year）]
16180719|NCT01540942|Other|surgery|bowel resection
16180720|NCT01540916|Other|Increase minute ventilation|Respiratory rate will be increase in order to have a 30% increase of minute ventilation
16180726|NCT01540877|Procedure|Application of 1 capsaicin 0.6% and 2. EMLA|topical application of 1. 0.6% capsaicin and 2. EMLA on the volar forearm
16180727|NCT01540877|Procedure|Application of 1. EMLA and 2. capsaicin 0.6%|topical application of 1. EMLA and 2. 0.6% capsaicin on the volar forearm
16180728|NCT01540864|Drug|HPP404|Administered orally once daily for 26 weeks
16180729|NCT01540864|Drug|Placebo|Administered orally once daily for 26 weeks
16180730|NCT01540851|Behavioral|Care Navigator|Subjects assigned to the Care Navigator intervention group will receive 10 calls from a care navigator after discharge from the hospital for 5 months after their total knee replacement.
16180731|NCT01540851|Other|Standard Post-Operative TKA Care|Subjects assigned to the Standard Post-Operative TKA Care group will receive the current standard of care for post-operative care
16180732|NCT01540838|Drug|Infusion with paracetamol|The administration of 250 mg/kg/24 hours cefotaxime during the first 4 days as continuous intravenous infusion, each single infusion lasting for 12 hours (to prevent degradation of the agent), combined with high-dose paracetamol orally; the first dose is 30 mg/kg, then 20 mg/kg every 6 hours for 4 full days.
16180733|NCT01540838|Drug|Bolus without paracetamol|The control intervention consists of 250 mg/kg/24 hours cefotaxime administered traditionally with intermittent i.v. boluses and the place bo of paracetamol orally, both repeated every 6 hours (qid) for 4 days.
16180734|NCT01540825|Drug|BI 113608|Low dose powder for oral solution
16180735|NCT01540825|Drug|BI 113608|High dose powder for oral solution
16180736|NCT01540825|Drug|BI 113608|Medium dose powder for oral solution
16180737|NCT01540825|Drug|BI 113608|Low dose powder for oral solution
16180738|NCT01540825|Drug|Placebo|Powder for oral solution
16180739|NCT01540825|Drug|BI 113608|Low dose powder for oral solution
16180740|NCT01540825|Drug|BI 113608|High dose powder for oral solution
16180741|NCT01540825|Drug|BI 113608|High dose powder for oral solution
16180742|NCT01540825|Drug|BI 113608|Medium dose powder for oral solution
16180743|NCT01540825|Drug|BI 113608|Medium dose powder for oral solution
16180744|NCT01540825|Drug|BI 113608|Low dose powder for oral solution
16180745|NCT01540812|Drug|Vincristine in induction|
16180746|NCT01540812|Drug|Daunorubicin in induction|
16180747|NCT01540812|Drug|Prednisone in induction|
16180748|NCT01540812|Drug|Metotrexato in induction|
16180749|NCT01540812|Drug|Cytarabine in induction|
16180750|NCT01540812|Drug|Hydrocortisone in induction|
16180751|NCT01540812|Drug|Idarubicin in induction-2|
16180752|NCT01540812|Drug|Fludarabine in induction-2|
16180753|NCT01540812|Drug|Ara-C in induction-2|
16180754|NCT01540812|Drug|G-CSF in induction-2|
16180755|NCT01540812|Drug|Dexamethasone in consolidation-1|
16180756|NCT01540812|Drug|Vincristrine in consolidation-1|
16180757|NCT01540812|Drug|Metotrexato in consolidation-1|
16180758|NCT01540812|Drug|PEG-ASP in consolidation-1|
16180759|NCT01540812|Drug|Dexamethasone in consolidation-2|
16180760|NCT01540812|Drug|ARA-C in consolidation-2|
16180761|NCT01540812|Drug|PEG-ASP in consolidation-2|
16180762|NCT01540812|Drug|Dexamethasone in consolidation-3|
16180763|NCT01540812|Drug|Vincristine in consolidation-3|
16180764|NCT01540812|Drug|Metotrexato in consolidation-3|
16180765|NCT01540812|Drug|PEG-ASP in consolidation-3|
16180766|NCT01540812|Procedure|allogeneic HSCT|
16180767|NCT01540812|Procedure|Allo HSCT with reduced-intensity conditioning|
16180768|NCT01540799|Device|ATI Neurostimulation System|ATI Neurostimulator (NS-100) and Remote Controller (RC-200)
16180769|NCT01540786|Procedure|High resolution urodynamic assessment|
16180770|NCT01540786|Procedure|Conventional urodynamic assessment|
16180771|NCT01540773|Drug|Amino acid supplement|An orally administered supplement of the proprietary amino acid derivative
16180772|NCT01540773|Drug|Placebo|A non-active orally administered supplement of the proprietary amino acid derivative
16180773|NCT01540760|Drug|MCAF5352A|Multiple ascending doses
16180774|NCT01540760|Drug|Placebo|Matching MCAF5352A, multiple doses
16180775|NCT01540747|Dietary Supplement|Myo-inositol + folic acid + melatonin|Myo-inositol (2000mg)+ folic acid (200 mcg)+ melatonin(3 mg)
16180776|NCT01540747|Dietary Supplement|Myo-inositol + folic acid|Myo-inositol (2000mg) + folic acid (200 mcg)
16180777|NCT01540734|Drug|Marketed paracetamol|Marketed formulation
16180778|NCT01540734|Drug|Experimental paracetamol formulation|Experimental formulation
16180779|NCT01540721|Drug|Marketed paracetamol|marketed formulation
16180780|NCT01540721|Drug|Experimental paracetamol formulation|Experimental formulation
16180781|NCT01540708|Drug|SERETIDE Rotacaps|The study will be conducted in 3 parts with an adaptive design where pharmacokinetic data analysis follows each part to enable a decision on whether progression to the subsequent parts is required. Thirty six subjects will be enrolled in each part. Part A will test an alternative version of the Rotahaler with a lower airflow resistance. The study will then test one or more of the following options depending on the outcome of part A. If progressed, part B will test modified Rotacap formulations including: (1) modified blend formulation, (2) reduced capsule fill weights, (3) different capsule types. Part B will also test other versions of the Rotahaler with intermediate airflow resistance. Part C will test the lower strength FP/salmeterol (100/50 mcg or lower) and/or a new unit dose DPI device (BUDI). In each arm, subjects will be administered 7 doses (3.5 days bid) with PK sampling following administration of the 7th dose on the morning of Day 4.
16180847|NCT01540188|Behavioral|Family Intervention to Address Drug Use and HIV in Vietnam|"Intervention for IDUs: there are 4 sessions of the intervention with the following titles: My family, my health, my actions, my community.
~Intervention for family members: there are 4 intervention sessions for family members covering the following topics: my family, my responsibility, my support and my community"
16180878|NCT01539824|Radiation|SBRT|The CyberKnife system is normally used for the treatment of cancerous tumours in cases where the type and position of the tumour and the condition of the patient indicate that treatment may be curative. In this study, the CyberKnife is being used in an experimental way to deliver a targeted dose of stereotactic body radiation with extreme accuracy in order to damage a single tumour growth (metastasis) in the liver.
16180782|NCT01540708|Drug|SERETIDE Diskus|The study will be conducted in 3 parts with an adaptive design where pharmacokinetic data analysis follows each part to enable a decision on whether progression to the subsequent parts is required. Thirty six subjects will be enrolled in each part. Part A will test an alternative version of the Rotahaler with a lower airflow resistance. The study will then test one or more of the following options depending on the outcome of part A. If progressed, part B will test modified Rotacap formulations including: (1) modified blend formulation, (2) reduced capsule fill weights, (3) different capsule types. Part B will also test other versions of the Rotahaler with intermediate airflow resistance. Part C will test the lower strength FP/salmeterol (100/50 mcg or lower) and/or a new unit dose DPI device (BUDI). In each arm, subjects will be administered 7 doses (3.5 days bid) with PK sampling following administration of the 7th dose on the morning of Day 4.
16180783|NCT01540682|Drug|MLN8237|Three dose levels of MLN8237 are planned:30, 40 and 50 mg po bid.
16180784|NCT01540682|Drug|Cetuximab|~ 1 week prior to the initiation of radiation therapy and continuing for a grand total of 12 weeks.
16180785|NCT01540682|Radiation|Radiotherapy|Radiotherapy will be administered in 2-Gy fractions, 5 days a week to a total dose of ~70 Gy.
16180786|NCT01540669|Dietary Supplement|Polydextrose, low dose|4g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks
16180787|NCT01540669|Dietary Supplement|Polydextrose, medium dose|8g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks
16180788|NCT01540669|Dietary Supplement|Polydextrose, high dose|12g polydextrose powder will be mixed with beverage and consumed once per day for 2 weeks
16180789|NCT01540669|Dietary Supplement|Placebo powder|Placebo powder will be mixed with beverage and consumed once per day for 2 weeks
16180790|NCT01540656|Device|Transcutaneous mechanical nerve stimulation (TMNS) (FERTI CARE)|"A medical vibrator (FERTI CARE personal, Multicept A/S, Albertslund, Denmark) will be used. The stimulation works through a vibrating disc of hard plastic with a diameter of 3.5 cm. The stimulation point will be the frenulum of the glans penis. The stimulation will be performed with a vibration amplitude of 2 mm and a frequency of 100 Hz.
~A daily stimulation sequence consisting of 10 seconds of stimulation followed by a 10 second pause repeated 10 times will be used through 6 weeks."
16180791|NCT01540643|Device|Iliac Leg Graft|Zenith® Spiral-Z® AAA Iliac Leg Graft
16180792|NCT01540630|Drug|CNV1014802|CNV1014802 150mg tid for 28 days. Dose may be increased to 350mg bid following interim evaluation of efficacy.
16180793|NCT01540630|Drug|Placebo|Double-blind placebo comparator for 28 days.
16180794|NCT01540604|Drug|CRD007|
16180795|NCT01540591|Drug|intralipid|IV infusion of intralipid 20% between day4 and 9 of ovarian stimulation & another dose when got pregnant within the 1st week of positive pregnancy test
16180796|NCT01540591|Drug|Saline|Saline 0.9% IV infusion between day4 and 9 of ovarian stimulation & another dose when got pregnant within the 1st week of positive pregnancy test
16180797|NCT01540578|Other|laboratory biomarker analysis|Correlative studies
16180798|NCT01540565|Other|Laboratory Biomarker Analysis|Correlative studies
16180799|NCT01540565|Drug|Veliparib|Given PO
16180800|NCT01540552|Other|medical chart review|
16180801|NCT01540552|Procedure|computed tomography|
16180802|NCT01540552|Procedure|computer-aided detection/diagnosis|
16180803|NCT01540539|Drug|REGN1154 or placebo|Participants will receive active drug or placebo
16180804|NCT01540526|Drug|axitinib|7 mg PO BID days 1-14 in 21 day cycles.
16180805|NCT01540513|Drug|NM404|"injection of 5.0mCi I-124 NM404 Arms: I124-NM404 brain metastases or GBM imaging
~Other Names:
~PET imaging with I-124 NM404"
16180806|NCT01540513|Drug|NM404|injection of an experimental imaging agent, 5mCi I-124NM404
16180807|NCT01540500|Drug|Tasimelteon|5.66 mg dose on Day 1 and Day 8
16180808|NCT01540500|Drug|Fluvoxamine|50 mg Dose on Days 2-8
16180809|NCT01540487|Drug|linagliptin/metformin(high dose)|patient would take fixed dose combination tablets of linagliptin /metformin (high dose) and single linagliptin and metformin (High dose) tablets single dose in random order, and each dosage will be separated in 42 days interval.
16180810|NCT01540487|Drug|Linagliptin/metformin(low dose)|patient would take fixed dose combination tablets of linagliptin /metformin (low dose) and single linagliptin and metformin (Low dose) tablets single dose in random order, and each dosage will be separated in 42 days interval.
16180811|NCT01540474|Biological|Group 1: 10 ug FMP012 with 2 ug GLA-SE|Biological/vaccine; E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipid A Stable emulsion (GLA-SE), a proprietary adjuvant
16180812|NCT01540474|Biological|Group 2: 10 ug FMP012 with 5 ug GLA-SE|E-coli expressed antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant
16180813|NCT01540474|Biological|50 ug FMP012 with 5 ug GLA-SE or 2 ug GLA-SE|E-coli expressed malaria antigen FMP012 adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant
16180814|NCT01540474|Other|Controlled group-Challenged Only: no vaccination|The control group participated in the primary malaria sporozoite challenge.E-coli expressed antigen FMP012 will be adjuvanted with Glucopyranosyl lipd A stable emulsion (GLA-SE), a proprietary adjuvant
16180815|NCT01540461|Drug|Brivanib|Tablets, Oral, 800 mg, Once daily, Until withdrawal of consent, disease progression or until unmanageable toxicity
16180816|NCT01540448|Procedure|Laparoscopic Right Hemicolectomy|We perform the Right Hemicolectomy (RH) with a 3 trocars technique. The procedure starts with the identification and sectioning of the ileocolic vessels at their origin. Next, is possible to divide the mesentery towards the terminal ileum, which was sectioned by laparoscopic linear stapler. The procedure continues with the incision of the Houston's ligament and the retroperitoneal dissection of the cecum and ascending colon up to the right flexure by pulling the terminal ileum upwards. During this maneuvers and eventually after the incision of the hepato-duodenocolic ligament, is possible to identify and cut the right colic vessels and, if necessary, the middle colic vessels and the Henle's venous branch.With the right colon and proximal transverse completely mobilized, it is possible to section the colon with a linear laparoscopic stapler and to create a 4-6 cm service incision to remove the specimen and perform an extracorporeal ileo-colic isoperistaltic mechanical anastomosis.
16180875|NCT01539837|Drug|Placebo|Feriprox placebo administered orally at the same dosing volume as the 20mg/kg/day feriprox per day
16180876|NCT01539837|Drug|Deferiprone 30mg|30mg/kg/d Deferiprone divided into two equal doses (morning and evening), every day for 6 months
16180817|NCT01540448|Procedure|Laparoscopic Left Hemicolectomy|We routinely perform the Left Hemicolectomy (LH) with a 3 trocars technique eventually placing the 4th trocar in the left flank if needed. The procedure started with the division of the gastro-spleno-colic ligament and the subsequent mobilization of the left colic flexure. Then is possible to identify and section the inferior mesenteric vessels. Performing LH the Inferior Mesenteric Artery (IMA) is usually tied immediately below the origin of the Left Colic Artery (LCA) while in presence of benign disease, to preserve the IMA, the dissection is performed along the course of the vessel, sectioning progressively the sigmoid arterial branches close to the colonic wall. When left colon is completely mobilized from the retroperitoneum along the avascular plane between the mesocolon and perirenal fat is possible to section the distal colon and finally perform a termino-terminal mechanical anastomosis.
16180818|NCT01540448|Procedure|Anterior Rectal Resection|We routinely perform the Anterior Rectal Resection (ARR) with a 3 trocars technique eventually placing the 4th trocar in the left flank if needed. The procedure started with the division of the gastro-spleno-colic ligament and the subsequent mobilization of the left colic flexure. Then is possible to identify and section the inferior mesenteric vessels. Performing ARR the Inferior Mesenteric Artery (IMA) is usually tied at origin but in particular cases it can be tied immediately below the origin of the Left Colic Artery (LCA). When left colon and is completely mobilized from the retroperitoneum along the avascular plane between the mesocolon and perirenal fat is possible to perform a partial or total mesorectal excision. Usually a termino-terminal mechanical anastomosis is performed at the end of the procedure.
16180819|NCT01540435|Drug|Bevacizumab|Bevacizumab at a dose of 5 mg/kg iv over 30 to 90 min (day 1) + FOLFOXIRI in a biweekly schedule, 6 cycles preoperatively, 6 cycles postoperatively
16180820|NCT01540409|Drug|AVI-4658 (Eteplirsen)|Eteplirsen will be administered once weekly via an IV infusion. There are two treatment groups, 30 mg/kg and 50 mg/kg.
16180821|NCT01540396|Behavioral|Dietary modification and medications|Patients diagnosed with gestational diabetes will receive dietary advice and instruction on blood glucose monitoring from their regular prenatal doctors, consistent with standard of care practices. Medications (glyburide, insulin) will be used as needed to assist with blood glucose control.
16180822|NCT01540383|Behavioral|Intensive integrative aphasia therapy|Intensive language therapy (3 weeks, 5 days/week, >=2 hours/day) provided in regular clinical setting and consisting of a combination of language systematic and communicative-pragmatic treatment
16180823|NCT01540383|Behavioral|Waiting list control group|Control group starts intensive language therapy after a 3-week waiting period.
16180824|NCT01540370|Other|No Treatment|No treatment
16180825|NCT01540357|Behavioral|Mindfulness-based therapy|Treatment was performed as group therapy at two training weekends which were separated by an interval of 7 weeks (eleven hours/weekend) and in four further two-hour sessions (week 2, 9, 18 and 22).
16180826|NCT01540357|Behavioral|Treatment after waiting time|Treatment was performed after completion of the active arm.
16180827|NCT01540344|Procedure|CRS|complete macroscopic cytoreduction (CC-0/1)
16180828|NCT01540344|Drug|HIPEC|bidirectional hyperthermic intraperitoneal chemotherapy (HIPEC) with 400 mg/sqm 5-FU + 20 mg/sqm folinic acid IV and 300 mg/sqm oxaliplatin IP
16180829|NCT01540331|Device|"model 1000 PNT vacuum controller (the vacuum device for ocular suction)"|A Pneumatic Trabeculoplasty treatment, composed of 3 single PNT applications at day 0, 7 and 90. Each treatment consist in a ocular pneumatic suction of 500inchHg administered for 60 seconds in perilimbal region through the device (model 1000 PNT vacuum controller). This suction is then repeated after a 5 minutes pause.
16180830|NCT01540318|Procedure|Abdominal Ultrasound (FAST examination)|Use of FAST abdominal ultrasound exam
16180831|NCT01540305|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|rTMS was administered by means of a NEURO-MS (NEUROSOFT LTD®, Russia) with a focal 8-shaped 70 mm coil. Stimulation parameters were 1-Hz, 20-min trains (1200 pulses/day) at 100% of resting MT, once a day, 5 days a week, for 2 weeks.
16180832|NCT01540305|Device|Sham repetitive transcranial magnetic stimulation|The sham treatment was performed using the Neurosoft ® sham coil. A metal plate placed inside this coil prevents the magnetic field from stimulating the cortex. This coil looks and sounds like an active coil.
16180833|NCT01540292|Biological|Mesenchymal Stem Cells (MSC)|MSC (1.5-2 cells/kg BW) IV injection, twice at 4 weeks apart
16180834|NCT01540266|Procedure|Information structuring|Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form
16180835|NCT01540266|Procedure|no information structuring|Students were independently shown one of two videos in which the same physician conveyed the identical 28 items of information to an older patient (played by an actor) in either structured or non-structured form
16180836|NCT01540253|Drug|PI3K inhibitor BKM120|Given PO
16180837|NCT01540253|Drug|docetaxel|Given IV
16180838|NCT01540253|Other|pharmacological study|Correlative studies
16180839|NCT01540253|Other|questionnaire administration|Ancillary studies
16180840|NCT01540253|Other|laboratory biomarker analysis|Correlative studies
16180841|NCT01540240|Drug|Zidovudine|Low dosage AZT arm: AZT 200 mg/3TC 150 mg(zidovudine 100 mg 2 caps/lamivudine 150 mg 1 cap) twice a day. Nevirapine 200 mg 1 cap twice a day.
16180842|NCT01540240|Drug|Zidovudine|Standard AZT arm: AZT 300 mg/3TC 150 mg(Combivir 1 cap) twice a day. Nevirapine 200 mg 1 cap twice a day.
16180843|NCT01540227|Drug|Regular Treatment for Syphilis|"Drug: Benzathine Penicillin G (Bicillin)
~Dose: 2.4 million units
~Mode of Administration: intramuscular injection
~Duration of Treatment: one dose
~Health Canada approved indication: Yes"
16180844|NCT01540214|Other|Pre- and postoperative evaluations|"At baseline before surgery and at 6 and 12 months after surgery: questionnaires, bladder diary, pelvic examination with additional ultrasound (one extra outpatient clinic visit at 6 months compared to standard care).
~At baseline before surgery and at 12 months after surgery: urodynamics with additional urine sampling (one extra outpatient clinic visit at 12 months compared to standard care).
~At time of surgery: additional cystoscopy."
16180845|NCT01540201|Other|Conventional I:E ratio|conventional I:E ratio of 1:2 is applied. Ventilator : Datex-Ohmeda Aestiva/5 ® model
16180846|NCT01540201|Other|I:E = 1:1 ratio|I:E ratio of 1:1 is applied Ventilator : Datex-Ohmeda Aestiva/5 ® model
16180877|NCT01539824|Biological|Mycobacterium obuense|IMM-101 is a suspension of heat-killed whole cell M. obuense in borate-buffered saline.
16180848|NCT01540175|Other|Blood samples obtained|Research participants agree to have blood samples obtained at the time of diagnosis before any chemotherapy, if available, and prior to high dose chemotherapy regimen with autologous HSCT as well as on days 14, 21, 28, week 8 and months 3, 6, 12 and 18 after autologous HSCT. Research participants with high risk neuroblastoma may also agree to have blood samples taken before and twice in the recovery period (days 0, 7 and 15-18) of Induction chemotherapy courses one and four.
16180849|NCT01540136|Drug|Nedaplatin|Nedaplatin 100mg/m2(3 weekly),D1,D22,D43 of RT
16180850|NCT01540136|Drug|Cisplatin|Cisplatin 100mg/m2(3 weekly),D1,D22,D43 of RT
16180851|NCT01540123|Dietary Supplement|Berry drink|Cold pressed berry drink standardised to contain 500mg of berry polyphenols
16180852|NCT01540123|Dietary Supplement|Control|Sugar matched control containing berry flavouring and no phytochemicals
16180853|NCT01540110|Drug|Neoadjuvant Docetaxel and Cyclophosphamide|"5.1.1 Docetaxel Docetaxel at a dose of 75 mg/m2 will be administered by intravenous infusion over 90 minutes (AFTER completion of cyclosphosphamide 600 mg/m2) on D1 every 21 days for 6 cycles using nonpolyvinylchloride tubing.
~Standard premedication with oral dexamethasone 8 mg bd on D-1, D1 and D2 will be administered. Alternatively, intravenous dexamethasone 8 mg before docetaxel followed by oral dexamethasone 8 mg bd on D1 and D2 can be given.
~Routine prevention of chemotherapy induced emesis will be administered (see 5.2.2)
~5.1.2 Cyclophosphamide
~Cyclophosphamide 600 mg/m2 by slow intravenous infusion over 10 minutes (BEFORE docetaxel) will be administered every 21 days for 6 cycles.
~No premedications are required except for routine prevention of chemotherapy induced emesis (see 5.2.2)"
16180854|NCT01540084|Drug|propofol|For induction, 25 mg of meperidine and 2.5 mg of midazolam were administered in both groups. In the cocktail group, one milligram per kilogram body weight of 1% propofol emulsion (Baxter Healthcare Corp., Irvine, CA) was slowly infused by an automated pump (Terufusion syringe pump TE-331, Terumo Corporation, Tokyo, Japan). To maintain conscious level of patient in the conventional group to be at moderate or deep level, 25 mg of meperidine and/or 2.5 mg of midazolam were administered as necessary, whereas patients in the cocktail group were continuously administered with 1% propofol at the rate of 1 mg/kg/hr. An additional 0.5 mg/kg bolus was administered as needed to achieve the designed conscious level.
16180855|NCT01540071|Drug|NRX 194204|NRX 194204 is an oblong, soft, gelatin capsule and will be taken once a day
16180856|NCT01540058|Other|Cancer Type ID test|"CancerTYPE ID is a real-time RT-PCR assay that measures and interprets the differential expression of 92 genes as a molecular correlate for tumor classification. The test classifies 28 main tumor types and 50 subtypes using an algorithm incorporating gene expression data from a reference database of 2,094 tumor specimens. CancerTYPE ID is used, in conjunction with other clinical and diagnostic procedures, to help identify tumor type and histological subtype. The performance characteristics and reproducibility of the test have been published previously (Erlander et al., 2011 ; Kerr et al., 2012).
~CancerTYPE ID is conducted on formalin-fixed paraffin-embedded (FFPE) tumor specimens at bioTheranostics' high complexity laboratory, which is certified by Clinical Laboratory Improvement Amendments (CLIA), accredited by the College of American Pathologists (CAP), and approved by the State of New York."
16180857|NCT01540058|Other|No test Empiric strategy|Empiric strategy
16180858|NCT01540032|Behavioral|Low salicylate diet|Patients will avoid foods from the 'high salicylate' group completely. They can eat foods from the 'low salicylate' group freely and just eat foods from the medium group occasionally, and not in large amounts.
16180859|NCT01540032|Behavioral|Normal diet|Patients will eat their usual diet.
16180860|NCT01540019|Drug|Paullinia cupana|50mg of Paullinia cupana as capsule, twice daily
16180861|NCT01540006|Other|Physical activity|50min of endurance training combined with 45min of calisthenics; 1-3x/week; 6-24 weeks
16180862|NCT01539980|Device|Sericin scaffold|Device: wound dressing containing silk sericin A scaffold from silk sericin-polyvinyl alcohol-glycerin blending are applied on one half of the skin graft donor site Device: fine mesh gauze impregnated with paraffin and 0.5%chlorhexidine acetate (Bactigras, Smith&Nephew, London, UK) are applied on the other half of the skin graft donor site
16180863|NCT01539967|Procedure|Laparoscopic Sleeve Gastrectomy|"the operative technique consists in few steps:
~position of 4 trocars and insertion of a nasogastric tube
~dissection and mobilization of the greater curvature of the stomach
~preparation of the stomach for division
~gastric partition
~extraction of the gastric remnant
~postoperative surveillance"
16180864|NCT01539941|Behavioral|Medication integration protocol|MIP is a 5 session protocol. The first session consists of pretreatment assessment activities using measures administered during routine clinical intake. The following sessions, MIP Sessions 1-4, are meant to be delivered sequentially, commencing sometime after session 2 or 3 of treatment, that is, after completion of initial treatment contracting and engagement interventions that will usually be focused on ASU-related referral problems for this population. The proposed pilot work will shed light on the optimal timing for MIP Sessions 1-4.
16180865|NCT01539928|Other|Dual FDG-PET/CT|Conventional FDG-PET/CT preformed after 1 hour and additional PET/CT 3 hours after injection
16180866|NCT01539915|Drug|BCT194|Topically applied BCT194 cream (0.5%)
16180867|NCT01539902|Biological|Human Umbilical Cord derived MSCs|Human Umbilical Cord derived MSCs treatment for lupus nephritis via infusion
16180868|NCT01539902|Drug|Cyclophosphamide|Cyclophosphamide based immunosuppressive agent for treatment for lupus nephritis
16180869|NCT01539889|Radiation|99mTC-PulmoBind|DFH-12 (PulmoBind) is a peptide derived from human adrenomedullin (hAMI-52). Adrenomedullin (AM) is a 52-amino acid peptide produced by many tissues in the body, including the vascular endothelium. 3 radiolabeled doses of PulmoBind will be used in this study (5mCi, 10mCi and 15mCi) 5 healthy subjects per dose for the 5 mci and the 10 mci groups but 10 subjects will be used for the 15 mci group.
16180870|NCT01539876|Procedure|Fine needle aspiration assessing tumour TNFa levels|Fine Needle aspiration will be done X5: 1 hr pre-treatment, 1hr post treatment,24 hrs post treatment, 48 hrs post treatment, and following last chemotherapy cycle
16180871|NCT01539863|Other|maintenance care|Participants will receive treatment at regular intervals during the study, a maximum of 12 and a minimum of 4 treatments as decided by the treating chiropractor
16180872|NCT01539863|Other|Treatment as needed|Participants may never receive treatment, there is no upper limit
16180873|NCT01539850|Device|OMS102|Subjects will receive implanted OMS102 System.
16180874|NCT01539837|Drug|Deferiprone 20mg|20mg/kg/d Deferiprone divided into two equal doses (morning and evening), every day for 6 months
16180879|NCT01539811|Procedure|Surgical incision and drainage of diabetic foot infection|Incision and drainage of diabetic foot infection with or without amputation of toes or the forefoot, depending on the condition of the foot
16180880|NCT01539811|Drug|Short course antibiotics|Short course (<2 weeks) of antibiotics will be prescribed
16180881|NCT01539811|Drug|Long course antibiotics|Long course (>2 weeks) of antibiotics will be prescribed
16180882|NCT01539798|Other|Oral saline|Ingestion of 2 L of 0.9% saline solution over 1h
16180883|NCT01539798|Other|Intravenous saline|Infusion of 2L of 0.9% saline solution over 1h
16180884|NCT01539785|Procedure|Secondary citoreduction|The eligible patients, after anesthesia preparation will be submitted to a surgical complete cytoreduction attempt that consist in the removal of all macroscopically visible tumor nodules from the visceral and parietal peritoneum. To obtain a complete cytoreduction, different procedures are required, as described by Sugarbaker (30), which may include omentectomy, splenectomy, diaphragmatic, pelvic,parietal peritonectomy and / or visceral, bowel resection, hepatic resection and cholecystectomy.
16180885|NCT01539785|Procedure|Hyperthermic intra-peritoneal chemotherapy (HIPEC)|If the patient is randomized to make chemo-hyperthermia, surgery will be followed by HIPEC with the closed technique, that consist in the perfusion of the abdominal cavity with a solution containing cisplatin (CDDP) 75 mg/m2 in 2L/m2 heated saline. The solution is heated and perfused with two special pumps (Hyperex, Korea or Stoeckert munich). The temperature of inflow and outflow of the solution, will be maintained, respectively, between 41 ° and 42.5 ° C. The intraperitoneal temperature will be maintained at 41.5 ° C and monitored by thermometers inserted into the subphrenic space and into the pelvis. After 60 minutes of perfusion the surgical incision will be open after removal of the entire solution. The global temperature will be measured by thermometer inserted into the esophagus and rectum. A Swan-Ganz catheter will be kept in place during the HIPEC for monitoring cardiovascular function.
16180886|NCT01539759|Device|Immediate Postplacental Placement of an IUD during cesarean delivery|Women randomized to this arm will have an IUD placed during their cesarean delivery, immediately after delivery of the placenta
16180887|NCT01539746|Procedure|TAVI without BAV|Avoidance of balloon valvuloplasty (BAV) of the native aortic valve before valve deployment
16180888|NCT01539746|Procedure|TAVI standard procedure|TAVI standard procedure including BAV before valve deployment
16180889|NCT01539733|Drug|Olanzapine|After randomisation to olanzapine treatment, olanzapine will be started at an initial dose of 2,5 - 5 mg orally or intramuscularly, after 2 hours subsequent titration of dosage will be based on clinical judgement with a maximum of 20 mg per 24 hours divided over a maximum of 3 gifts. Sustenance dose will consist of half of the total titrated dose per 24 hours in one gift.
16180890|NCT01539733|Drug|Haloperidol|After randomisation to haloperidol treatment, haloperidol dosing will be titrated, with repeated dosing of 0,5 - 2mg orally or subcutaneously every 40 minutes until signs of delirium diminish, with a maximum of 20 mg orally or 10 mg subcutaneously per 24 hours. Sustenance dose will consist of half of the total titrated dose per 24 hours in one or two gifts.
16180891|NCT01539720|Drug|Ulipristal acetate|30 mg tablet
16180892|NCT01539720|Device|levonorgestrel IUS|Levonorgestrel IUS, 52mg placed intrauterine
16180893|NCT01539707|Drug|Solifenacin succinate suspension 5 mg|Adolescents and children are given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses are calculated per weight of the participant, targeting to have equivalent dose of 5 mg dose of solifenacin once daily in adults (referred to as PED of 5 mg).
16180894|NCT01539694|Device|LD118033 contact lens|Multifocal contact lens worn on a daily wear basis for 1 week
16180895|NCT01539694|Device|PureVision multifocal contact lens|PureVision multifocal contact lens worn on a daily wear basis for 1 week.
16180896|NCT01539681|Drug|Sorafenib (Nexavar, BAY43-9006)|Subjects should be treated with sorafenib in compliance with the recommendations written in the local product information.However, the decision on the duration and dose of treatment is at the discretion of the prescribing physician.
16180897|NCT01539655|Drug|vandetanib|Oral tablets, 300 mg, single dose
16180898|NCT01539655|Drug|omeprazole|Oral capsules, 40 mg, multiple doses
16180899|NCT01539655|Drug|ranitidine|Oral tables, 150 mg, multiple doses
16180900|NCT01539642|Drug|Sufentanil NanoTab PCA System/15 mcg|15 mcg Sufentanil NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patient may elect to remain in study for up to 72 hours.
16180901|NCT01539642|Drug|Placebo Sufentanil NanoTab PCA System|Placebo NanoTab dosed sublingually every 20 minutes as needed for pain for up to 48 hours. Patient may elect to remain in study for up to 72 hours.
16180902|NCT01539629|Device|Cardiac pacing|Cadiac pacing via a pulse generator and implaned intracardiac leads.
16180903|NCT01539616|Drug|ZYH7|ZYH7 4mg given once orally in the morning before breakfast, for 8 weeks.
16180904|NCT01539616|Drug|ZYH7|ZYH7 8 mg given once orally in the morning before breakfast, for 8 weeks.
16180905|NCT01539616|Drug|ZYH7|ZYH7 16 mg given once orally in the morning before breakfast, for 8 weeks.
16180906|NCT01539616|Drug|Fenofibrate|Fenofibrate 160 mg given once orally in the morning before breakfast, for 8 weeks.
16180907|NCT01539603|Device|Drug eluting balloon + Bare metal stent|PCI using Sequent Please and then Coroflex Blue
16180908|NCT01539603|Device|drug eluting stent (Zotarolimus-eluting stent)|conventional PCI using Endeavor Integrity
16180909|NCT01539590|Drug|BB3|Daily intravenous administration of 2 mg/kg BB3 for four (4) days
16180910|NCT01539590|Drug|Normal saline|Daily intravenous administration for four (4) days. The volume of normal saline will vary by estimated weight.
16180911|NCT01539577|Drug|dexamethasone 700 μg intravitreal implant|dexamethasone 700 μg intravitreal implant administered according to general clinical practice.
16180912|NCT01539564|Drug|Minocycline HCl Microspheres|
16180913|NCT01539551|Other|check BNP and lactate|we will collect patients's blood samples on Day 0, Day1 and Day2
16180914|NCT01539538|Drug|Sufentanil NanoTab PCA System/15 mcg|15 mcg Sufentanil NanoTab dosed sublingually q 20 minutes as needed for pain for at least 48 hours and up to 72 hours
16180915|NCT01539538|Drug|morphine IV PCA|1 mg morphine administered IV q 6 minutes as needed for pain for at least 48 hours and up to 72 hours
16180916|NCT01539525|Behavioral|Motivational Interview|Motivational Interview provided by either a Nurse or Computer
16187757|NCT01488877|Other|placebo|placebo once daily
16180917|NCT01539525|Other|Treatment as Usual|Subjects given a brochure listing relevant recovery resources in the local area.
16180918|NCT01539512|Drug|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily
16180919|NCT01539512|Drug|Rituximab|Rituximab administered intravenously 8 times through Week 20: Day 1: 375 mg/m^2, and 500 mg/m^2 thereafter
16180920|NCT01539512|Drug|Placebo to match idelalisib|Placebo to match idelalisib administered orally twice daily
16180921|NCT01539473|Drug|TR-701 FA with Tyramine|TR-701 FA 200 mg oral and Tyramine
16180922|NCT01539473|Drug|Placebo-controlled withTyramine|Placebo-controlled and Tyramine
16180923|NCT01539460|Procedure|minimally invasive surgery|Subcutaneous fat and apocrine sweat glands were removed by suction under tumescent anesthesia,and the remaining tissue and glands, tightly attached to the epidermis-dermis interface, were completely removed with scissors through the initial small incision.
16180924|NCT01539447|Drug|Naproxen|• Group 1: Naproxen 500 mg twice daily for three weeks following surgery beginning postoperative day #1
16180925|NCT01539447|Drug|placebo|• Group 2: Placebo twice daily for three weeks following surgery beginning postoperative day #1
16180926|NCT01539434|Behavioral|Behavioural intervention|Patients in the behavioural intervention group will get a personal meeting with the physiotherapist and get advice about the value of physical activity and also get recommendations on how to be physically active. The behavioural intervention to support physical activity behaviour includes weekly motivational interviewing telephone calls for the first month, two telephone calls for the following two months and thereafter monthly telephone calls.
16180927|NCT01539434|Behavioral|Usual care group|Patients in the usual care group will get a personal meeting with the physiotherapist and get advice about the value of physical activity and also get recommendations on how to be physically active.
16180928|NCT01539421|Behavioral|Use of Home exercise computer program|After a 30-minute rest period the study patient performed a series of 4 representative exercises from the Wii under direct supervision by an investigator. Five minutes' rest was allotted between each exercise. The patient was instructed to exercise at his/her own pace, with a maximal duration of 5 minutes per exercise. The Oxycon Mobile was worn throughout this exercise, and the metabolic measurements listed above were recorded over the last 30 seconds of each exercise. The exercises included running in place, upper arm movements, stepping in place, and obstacle course.
16180929|NCT01539408|Drug|Misoprostol|single dose of 400 mcg misoprostol administered sublingually
16180930|NCT01539408|Procedure|surgery Manual vacuum aspiration (MVA)|standard surgical treatment
16180931|NCT01539395|Other|MSDx Complex-1 Biomarker Test|A biomarker test for the level of MSDx Complex-1
16180932|NCT01539382|Procedure|Cerebral oxygenation intervention|The protocol for interventions to increase cerebral oxygenation levels above 60% optimizing pH, PaO2, PaCO2, bispectral index, central venous pressure, mean arterial pressure, venous oxygen saturation, and hematocrit. In addition, cerebral perfusion pressure of 70-80 mm Hg and flow >2.0 l/min/m2 will be maintained during cardiopulmonary bypass. In the ICU, temperatures will be maintained below 38 degrees by administering antipyretics or cooling, and dexmedetomidine will be used if the patient is agitated.
16180933|NCT01539369|Other|Healthy eating diet (Diet A) or healthy eating diet combined with advice to increase fibre intake (Diet B) to at least 25g/day|"Participants were randomly assigned to one of two parallel arms:
~Diet A:healthy eating without extra advice to increase fibre intake or Diet B: healthy eating with extra advice to increase fibre intake to a minimum of 25g/d. Healthy eating advice was based on the British Heart Foundation booklet: Food Should Be Fun And Healthy. Participants following Diet A were encouraged to eat breakfast cereals and were provided with complementary cereals and snacks low in fibre. Participants following Diet B were encouraged to eat high fibre breakfast cereals and to incorporate wheat bran fibre in other meals. Complementary high fibre cereals and snacks were provided."
16180934|NCT01539343|Drug|Antimicrobial Solution|Antimicrobial solution, consisting of minocycline in combination with 30mg/ml of a chelator (EDTA) in 25% ethanol solution (HEAL solution), instilled in central venous catheter (CVC) catheter for 2 hours once daily for a minimum of 5 consecutive days. Lock therapy also received once weekly for two additional weeks.
16180935|NCT01539330|Drug|Voriconazole|"At beginning of study visit 1 (0-12 h): 6 mg/kg, IV (in the vein) over a period of 120 min
~at beginning of study visit 2 (12-24 h): 6 mg/kg, IV (in the vein) over a period of 120 min
~at beginning of study visit 3 (24-36 h): 4 mg/kg, IV (in the vein) over a period of 80 min
~at beginning of study visit 4 (36-48 h): 4 mg/kg, IV (in the vein) over a period of 80 min
~at beginning of study visit 5 (48-60 h), 6 (60-72 h) and 7 (72-84 h): 200 mg po"
16180936|NCT01539330|Other|microdialysis|long-term microdialysis over study days 1-4 (visits 1-7)
16180937|NCT01539317|Drug|Topical liquid lidocaine|active intervention drug numbs the hypersensitive mucosa of the vulvar vestibule
16180938|NCT01539317|Drug|Topical saline|saline applied to the vestibule mucosa will not reverse the local tenderness
16180939|NCT01539304|Drug|CITUS Dry Syrup|Pranlukast 10% dry syrup, b.i.d.
16180940|NCT01539304|Drug|Placebo|Placebo dry syrup, b.i.d
16180941|NCT01539291|Drug|Idelalisib|Idelalisib tablet(s) administered orally twice daily
16180942|NCT01539278|Procedure|Adenotonsillectomy|Tonsils and adenoids are surgically removed
16180943|NCT01539278|Other|Observation alone / no intervention|Patients are observed over time, no surgery is done, subjects complete QOL questionnaires at set intervals
16180944|NCT01539265|Drug|silodosin|
16180945|NCT01539265|Drug|silodosin|
16180946|NCT01539265|Drug|placebo|
16180947|NCT01539252|Procedure|Single dialyzer|Hemodialysis treatment using a single Baxter dialyzer - considered standard hemodialysis treatment.
16180948|NCT01539252|Procedure|Two dialyzers|Hemodialysis treatment using a two Baxter dialyzers in parallel.
16180949|NCT01539239|Device|Hydrus Aqueous Implant|The Hydrus Aqueous Implant is a crescent-shaped nitinol device intended to be a permanent implant placed through the trabecular meshwork into Schlemm's Canal, immediately following placement of a monofocal IOL.
16180950|NCT01539239|Procedure|Cataract surgery|A monofocal intraocular lens (IOL) placed during the cataract surgery.
16180951|NCT01539226|Combination Product|Placebo Vaginal Ring|Dapivirine Vaginal Ring containing 0.0 mg of dapivirine
16180952|NCT01539226|Combination Product|Dapivirine Vaginal Ring, 25 mg|Dapivirine Vaginal Ring containing 25 mg of dapivirine
16180953|NCT01539213|Drug|secukinumab (AIN457)|anti-IL-17 antibody
16180954|NCT01539200|Dietary Supplement|ONS+JDR|Oral Nutritional Supplement with Jacques-Delacroze Eurythmic training
16180955|NCT01539200|Dietary Supplement|JDR|Jacques-Delacroze Eurythmic training with placebo ONS
16180956|NCT01539187|Device|VizAblate System|VizAblate enables a minimally invasive procedure to visualize, target, and ablate uterine fibroids using intrauterine ultrasound and radiofrequency (RF) energy
16180957|NCT01539174|Biological|rituximab|Given IV
16180958|NCT01539174|Drug|cyclophosphamide|Given IV
16180959|NCT01539174|Drug|doxorubicin hydrochloride|Given IV
16180960|NCT01539174|Drug|vincristine sulfate|Given IV
16180961|NCT01539174|Drug|prednisone|Given PO
16180962|NCT01539174|Other|laboratory biomarker analysis|Correlative studies
16180963|NCT01539174|Other|pharmacological study|Correlative studies
16180964|NCT01539161|Device|Implantable Cardiac Monitor|9529 Reveal XT Implantable Cardiac Monitor as well as the use of 9539 Reveal XT Patient Assistant.
16180965|NCT01539161|Procedure|Standard of Care|Standard of care arm including exam, ECG and Holter every 6 months, and an Echo, Chest X-Ray and Stress test every 12 months.
16180966|NCT01539135|Drug|Methylene Blue|20 cc methylene blue instilled above the cuff once after intubation for the duration of the surgical procedure
16180967|NCT01539122|Device|Zimmer TM Glenoid|The Zimmer TM glenoid will be used for the glenoid shoulder replacement component.
16180968|NCT01539122|Device|Cemented Glenoid|A cemented glenoid will be used for the glenoid component of the total shoulder replacement.
16180969|NCT01539109|Behavioral|Rehabilitation|Patients will receive training upon tasks of daily living. Patients will perform these exercises in our laboratory under the supervision of qualified personnel.
16180970|NCT01539109|Procedure|Noninvasive brain stimulation: tDCS|TDCS is a method of noninvasive stimulation of the brain. Using electrodes placed in saline-soaked sponges, low level of direct current (2mA) is delivered over the scalp. This intervention is considered safe and noninvasive because it does not involve implantation or injection or any skin penetration. In the present study, tDCS will be delivered to patients in the experimental group for 2 hr each day for 5 days a week for 2 weeks in conjunction with therapy for the affected hand.
16180971|NCT01539109|Procedure|Sham tDCS: placebo noninvasive brain stimulation|Placebo set-up for noninvasive brain stimulation will be similar to that for the active tDCS; sponge electrodes would be placed on the scalp and connected to a batter-operated device. Patients will not receive the effective level of direct current as would delivered in active tDCS intervention. But patients will not be able to decipher whether they are receiving active or placebo tDCS.
16180972|NCT01539096|Procedure|tDCS: noninvasive brain stimulation|TDCS is a method of noninvasive stimulation of the brain. Using electrodes placed in saline-soaked sponges, low level of direct current (1mA) is delivered over the scalp. This intervention is considered safe and noninvasive because it does not involve implantation or injection or any skin penetration. In the present study, tDCS will be delivered for 1 hr each day for 3 days a week for 5 weeks in conjunction with constraint-induced movement therapy for the affected hand.
16180973|NCT01539096|Behavioral|Constraint induced movement therapy (CIMT)|Patients with stroke affecting the hand will receive constraint-induced movement therapy (CIMT) to re-train movements of the affected hand. Training will involve practicing tasks of daily living with qualified personnel. Training will be delivered for 1 hr each day for 3 days a week for 5 weeks. Patients will also be asked to use their affected hand in daily activities at home for 5 hrs a day while wearing a mitt on the unaffected hand.
16180974|NCT01539096|Procedure|Sham tDCS: placebo noninvasive brain stimulation|Placebo set-up for noninvasive brain stimulation will be similar to that for the active tDCS; sponge electrodes would be placed on the scalp and connected to a batter-operated device. Patients will not receive the effective level of direct current as would delivered in active tDCS intervention. But patients will not be able to decipher whether they are receiving active or placebo tDCS.
16180975|NCT01539083|Drug|Thalidomide|Thalidomide 100 mg tablet, orally.
16180976|NCT01539083|Drug|Bortezomib|Bortezomib 1.3 milligram per square meter (mg/m^2) solution for injection subcutaneously (SC).
16180977|NCT01539083|Drug|Cyclophosphamide|Cyclophosphamide 300 mg/m^2 orally.
16180978|NCT01539083|Drug|Dexamethasone|Dexamethasone 20 mg orally.
16180979|NCT01539083|Drug|Prednisolone|Prednisolone 50 mg orally.
16180980|NCT01539070|Behavioral|Eating and physical activity counseling|"The parents of overweight children will be invited to attend a total of 6 group sessions (the group will be comprised of 6 children with their parents) on a weekly basis, in which 5 aspects will be dealt with 1) Dietary culture, risk-benefit practices, 2) The process of feeding (acquisition/preparation/service Eating behaviors), 3) Physical activity habits, 4) Importance of weighing/measuring oneself and its meaning, 5) feedback and evaluations. These aspects and contents will be distributed throughout the 6 sessions.
~There will be two more individual session, at 3 and 6 months respectively, for the reinforcement of recommendations provided for the modification of dietary behaviors and physical activity."
16180981|NCT01539057|Drug|Fibrinogen|"The dose of fibrinogen should be calculated at 1 g of fibrinogen in order to obtain an increase in plasma fibrinogen value of 0.29 g / L to reach a final value of 2.9 g / L.
~Fibrinogen ampoules powder prepared with water dilution and located in a serum at a concentration of 2g/100 ml, which will be administered by intravenous infusion for 10 minutes.
~Administration before surgery starts"
16180982|NCT01539057|Drug|Saline|the same dose in volume of water dilution will be administered. The potential dose of fibrinogen required to obtain a final plasmatic reading of 2.9 g / L. will be computed. A serum will contain the corresponding ml of water dilution. Administered before surgery starts
16180983|NCT01539044|Drug|Neostigmine, atropine|0.05 mg/KG NEOSTIGMINE AND 0.02 MG/ KG ATROPINE at TOF 2
16180984|NCT01539044|Drug|Sugammadex|4 mg/kg sugammadex will be given stat at the end of surgery at PTC 1-2
16180985|NCT01539031|Drug|E2020|"Subjects in the Group-10 mg:
~Week 1 to 4: Once daily donepezil 10 mg and placebo matching donepezil 5 mg, Week 5 to 28: Once daily donepezil 10 mg and placebo matching donepezil 23 mg, Week 29 to 32: Once daily donepezil 5 mg, 10 mg and placebo matching donepezil 23 mg, Week 33 to 52: Once daily donepezil 23 mg"
16180986|NCT01539031|Drug|E2020|"Subjects in the Group-23 mg:
~Week 1 to 4: Once daily donepezil 5 mg and 10 mg, Week 5 to 28: Once daily donepezil 23 mg and placebo matching donepezil 10 mg, Week 29 to 32: Once daily donepezil 23 mg, and placebo matching donepezil 5 mg and 10 mg, Week 33 to 52: Once daily donepezil 23 mg"
16180987|NCT01539018|Drug|Sorafenib|Sorafenib 400 mg p.o. twice daily until progression or intolerable toxicity alone.
16180988|NCT01539018|Drug|sorafenib plus tegafur-uracil|Sorafenib 400 mg p.o. twice daily until progression or intolerable toxicity and TEGAFUR-URACIL 125mg/m2 PO BID For 4 weeks and to be repeated on day 36 till progression or intolerance
16180989|NCT01538992|Device|Standard steerable Marinr RF ablation Catheter (5F or 7F)|Intervention: Device: Standard steerable Mariner Radiofrequency ablation Catheter (5F or 7F)
16180990|NCT01538979|Biological|BM32|Subcutaneous injection of 20 micrograms of each of the protein components of BM32 adsorbed on 0.6 mg of aluminum hydroxide every 4 weeks for a total of 3 injections before each pollen season and one boost injection after pollen season
16180991|NCT01538979|Biological|BM32|Subcutaneous injection of 40 micrograms of each of the protein components of BM32 adsorbed on 1.2 mg of aluminum hydroxide every 4 weeks for a total of 3 injections before each pollen season and one boost injection after pollen season
16180992|NCT01538979|Biological|Placebo|Subcutaneous injection of 1.2 mg of aluminum hydroxide suspension every four weeks before each pollen season and one injection after pollen season for a total of 7 injections
16180993|NCT01538966|Drug|Pegvisomant|
16180994|NCT01538966|Drug|Octreotide LAR|
16180995|NCT01538966|Drug|Lanreotide|
16180996|NCT01538953|Other|handwashing|participants received weekly in-home handwashing promotion and soap as needed
16180997|NCT01538953|Other|flocculent-disinfectant for water treatment|participants received a supply of flocculent-disinfectant product for water treatment and instruction in how to use it
16180998|NCT01538953|Other|water treatment with sodium hypochlorite|participants received a supply of dilute sodium hypochlorite and instruction to treat drinking water with it
16180999|NCT01538940|Biological|Intradermal vaccine|15ug
16181000|NCT01538940|Biological|Intramuscular vaccine|15ug
16181001|NCT01538927|Drug|Fibrin Sealant|Fibrin Sealant 4ml (Baxter Tisseel)
16181002|NCT01538927|Drug|Suture|Black silk 000
16181003|NCT01538914|Procedure|paravertebral block|Postoperative pain is controlled with local analgesics via PVB.
16181004|NCT01538914|Procedure|PCA|Postoperative pain is controlled with intravenous PCA.
16181005|NCT01538901|Other|photodynamic therapy|Methyl-aminolaevulinate 16% cream (Metvix) will be applied on the treated area under occlusion for 3 hours. It follows irradiation with visible red light at a peak wavelength of 630 nm (Actilite CL128) with a single dose of 37 J/cm2.
16181006|NCT01538901|Drug|imiquimod 5% cream|250 mg imiquimod 5% cream will be applied over night for a total of 3 nights in the week, for duration of 4 weeks
16181007|NCT01538888|Procedure|WHOLE BODY VIBRATION|03 MONTHS, TWICE PER WEEK
16181008|NCT01538875|Drug|Hydralazine|Patients with an hypertensive crisis during pregnancy will receive 5mg IV every 15 minutes until high blood pressure is controlled (Maximum number of doses: 3).
16181009|NCT01538875|Drug|Labetalol|Patients with an hypertensive crisis during pregnancy will receive 20 mg of Labetalol IV. After 15 minutes if the crisis continue, 40 mg IV. After 15 minutes if the crisis continue, 80 mg IV. Then, if the crisis continue, 80 mg IV every 15 minutes (maximum dose: 300 mg IV in total).
16181010|NCT01538862|Drug|Granulocyte Colony Stimulating Factor (GCSF)|G-CSF 10mcg/kg/d SQ for 7 days
16181011|NCT01538849|Drug|Esomeprazole 40mg|1 tablet = Esomeprazole 40 mg
16181012|NCT01538849|Drug|YH4808 A mg|1 tablet = YH4808 A mg
16181013|NCT01538849|Drug|YH4808 B mg|1 tablet = YH4808 B mg
16181014|NCT01538849|Drug|YH4808 C mg|YH4808 C mg = 2 x YH4808 B mg
16181015|NCT01538836|Behavioral|Weight loss with normal protein intake|Goal of 8 to 10% weight loss while consuming the recommended daily allowance of protein (i.e, 0.8 grams of protein per kg body weight per day).
16181016|NCT01538836|Behavioral|Weight loss with protein supplementation|Goal of 8 to 10% weight loss while consuming 150% of the recommended daily allowance of protein (i.e., 1.2 grams of protein per kg body weight per day).
16181017|NCT01538797|Drug|YF476|There were 5 treatments: 3 dose levels of YF476 (5, 25 and 100 mg), placebo and ranitidine 150 mg. There were at least 7 days between consecutive Treatment Days.
16181018|NCT01538797|Drug|Ranitidine|There were 5 treatments: 3 dose levels of YF476 (5, 25 and 100mg), placebo and ranitidine 150mg. There were at least 7 days between consecutive Treatment Days.
16181019|NCT01538784|Drug|YF476|"Two groups of six subjects received single rising oral doses of YF476 capsules or matching placebo. Each subject received 2 doses of YF476 and 1 dose of placebo. 4 subjects received active and 2 placebo at each dose level, as follows:
~Group A YF476 0.5, 25 and 100mg by mouth Group B YF476 5.0, 50 and 100mg by mouth
~Groups A & B were dosed alternately, at weekly intervals"
16181020|NCT01538771|Drug|Darbepoetin alfa|Darbepoetin alfa 300ug intracoronary bolus infusion via over-the-wire balloon before the 1st ballooning and conventional treatment
16181021|NCT01538771|Drug|Control Saline|Same volume of saline intracoronary bolus infusion via over-the-wire balloon before the 1st ballooning and conventional treatment
16181022|NCT01538758|Other|Us guided needling|"Us guided needling is a therapeutical technique treating calcifying tendinitis of the shoulder. Calcifications in the rotator cuff tendon are visualised with ultrasound. Under ultrasound guidance a 20 gauge needle is inserted in the calcification. Lidocaine 1% in a 1cc syringe is injected in the calcification and aspirated. The calcification is flushed until the fluid is clear. Sometimes it is not possible to flush the calcification. In this case the calcification will be fragmented.
~After flushing or fragmentation of the calcification, 20 mg triamcinolone with 1cc lidocaine 1% will be injected in de subacromial bursa under us guidance."
16181023|NCT01538758|Other|corticosteroid injection|Us guided subacromial bursa injection with 20 mg triamcinolone with 1cc lidocaine 1%.
16181024|NCT01538745|Drug|Ketamine|0.3 mg/kg ketamine Intravenous push (IVP) over 5 minutes. Total of two possible doses.
16181025|NCT01538745|Drug|Morphine|0.1 mg/kg Morphine IVP over 5 minutes. Total of two possible doses.
16181026|NCT01538732|Drug|alitretinoin|30mg capsules (Alitretinoin)will be taken peroral once daily with a meal. Study treatment will be given for a total duration of up to 24 weeks
16181027|NCT01538719|Drug|Rilonacept|Patients randomized to active study drug will receive Rilonacept 320 mg subcutaneously (SQ) on day 0 and 160 mg SQ each week for 5 additional weeks
16181028|NCT01538719|Other|Placebo|Patients randomized to placebo will receive saline subcutaneously (SQ) on day 0 and each week for 5 additional weeks
16181029|NCT01538706|Other|Hospital-based home care|Low-intensive intravenous antibiotics b) intravenous low-toxic chemotherapy c) blood samples drawn from the central venous catheter or peripheral vein d) subcutaneous injections e) nutrition treatment f) pain management (e.g. controlling an intravenous morphine pump g) supportive care e.g. changing dressings.
16181030|NCT01538693|Drug|escitalopram oxalate|10 mg 4.5 hours prior to testing
16181031|NCT01538693|Drug|Cyproheptadine|8mg 4.5 hours prior to testing
16181032|NCT01538693|Drug|sugar pill|4.5 hour prior to testing
16181033|NCT01538693|Other|Graded intensity exercise|modified bruce protocol for peak oxygen consumption testing
16181034|NCT01538680|Drug|Regorafenib (BAY73-4506)|"Subjects will receive 160 mg regorafenib po every day (qd) for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off). Subjects will continue on treatment until at least one of the following occurs (main criteria):
~Progressive Disease (PD). The subject may continue treatment at the investigator's discretion.
~Death Unacceptable toxicity Subject withdraws consent Treating physician determines discontinuation of treatment is in the subject's best interest Substantial non-compliance with the protocol"
16181035|NCT01538667|Drug|Ciprofloxacin (Cipro Inhale, BAYQ3939)|50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by healthy subjects
16181036|NCT01538667|Drug|Ciprofloxacin (Cipro Inhale, BAYQ3939)|50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by healthy subjects under charcoal block
16181037|NCT01538667|Drug|Ciprofloxacin (Cipro Inhale, BAYQ3939)|50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by COPD patients
16181038|NCT01538667|Drug|Ciprofloxacin (Cipro Inhale, BAYQ3939)|50 mg single powder dose of 99mTc labeled ciprofloxacin PulmoSphere inhalation powder inhaled by bronchiectasis patients
16181039|NCT01538654|Procedure|enteral protein tube feeding in obese|The intervention is represented by a new alternative to treat obese patients by means of a protein sparing modified fast administered by continous 24 h enteral feeding
16181040|NCT01538641|Drug|Rituximab, Gemcitabine, Oxaliplatin|Rituximab:375 mg/m2; on day 1 of each 14 days cycle. Gemcitabine:1,000 mg/m2 on day 2 of each 14 days cycle. Oxaliplatin:100 mg/m2; on day 2 of each 14 days cycle. Total number of cycles: 6 cycles.
16181041|NCT01538628|Device|SpaceOAR System|Fiducial marker placement followed by randomization to treatment group, i.e., 10mL SpaceOAR hydrogel injection, or control group, i.e., no injection of SpaceOAR hydrogel.
16181042|NCT01538615|Behavioral|HOME Plus intervention|The HOME Plus program families will participate in monthly, two-hour group sessions for ten months at local community centers. Each session offers new ideas focusing on family meals, healthy eating, and reducing sedentary behavior. At each session, families prepare and eat a meal together and participate in small group discussions and activities for both parent and child groups to promote healthy behaviors in the home. Topics include planning healthy meals and snacks with your family, having meals with your family more often, and improving the healthfulness of the food available at home. Families also receive periodic supportive phone calls throughout the year using motivational interviewing techniques to promote healthy behaviors to prevent and reduce childhood obesity.
16181043|NCT01538589|Drug|insulin aspart|Prescribed by the physicians as a result of normal clinical practice
16181044|NCT01538576|Drug|insulin aspart|Prescribed by the physicians as a result of normal clinical practice
16181045|NCT01538563|Drug|rigosertib sodium|Patients will receive escalating doses of ON 01910.Na (250 mg/m2 to 4450 mg/m2) intravenously by 24 hour continuous infusion once every week (3 weeks per cycle), until evidence of disease progression, intolerable adverse events, or withdrawal of patient consent.
16181046|NCT01538550|Procedure|Flexible sigmoidoscopy|Flexible sigmoidoscopy screening is offered once only
16181047|NCT01538550|Procedure|iFOBT|Biennial screening with iFOBT
16181048|NCT01538537|Drug|rigosertib sodium|ON 01910.Na will be supplied as a sterile, concentrated solution (75 mg/ml) in labeled, sealed glass vials. ON 01910.Na concentrated solution (75 mg/ml) must be diluted before intravenous administration. The starting dose will be 50 mg/m2 over 24 hour infusion daily for 3 days. A fresh infusion must be prepared for each day of the 3-day continuous infusion. This 3-day continuous treatment followed by 11 days without administration of study drug will constitute 1 Cycle. Cycles can be repeated every 2 weeks. The dosing of ON 01910.Na will be based on body surface area (BSA). In the absence of toxicity that would cause accelerated dose escalation to cease, drug doses are planned to escalate every 3 weeks.
16181049|NCT01538511|Drug|biphasic insulin aspart 70|Administered subcutaneously (s.c., under the skin) three times daily immediately before breakfast, lunch and dinner for 4 weeks. Dose individually adjusted
16181050|NCT01538511|Drug|biphasic insulin aspart 30|Administered subcutaneously (s.c., under the skin) twice daily immediately before breakfast and dinner for 4 weeks. Dose individually adjusted
16181051|NCT01538485|Drug|Cholecalciferol|weekly dose (based on 70IU KG body weight/day)
16181052|NCT01538472|Drug|Y Zevalin|Starting dose: 0.4 mCi/kg by vein after Rituxan infusion on Day -14.
16181053|NCT01538472|Drug|In Zevalin|Imaging dose: 5 mCi by vein following Rituxan infusion on Day -21.
16181054|NCT01538472|Drug|Rituxan|"250 mg/m2 by vein on Day -21 and on Day -14.
~1000 mg/m2 by vein on Days +1 and +8."
16181055|NCT01538472|Drug|BCNU|300 mg/m2 by vein on Day -6.
16181056|NCT01538472|Drug|VP -16|200 mg/m2 by vein every 12 hours on Days -5, -4, -3, and -2.
16181057|NCT01538472|Drug|Ara-C|200 mg/m2 by vein every 12 hours on Days -5, -4, -3,and -2.
16181058|NCT01538472|Drug|Melphalan|140 mg/m2 by vein on Day -1.
16181059|NCT01538472|Procedure|Stem Cell Infusion|Autologous stem cell infusion on Day 0.
16181060|NCT01538472|Drug|G-CSF|5 mg/kg by vein daily starting Day 0 till recovery of granulocytes of 4.0 x 109/L.
16181061|NCT01538459|Drug|Dexamethasone|8mg (2cc 4mg/cc Solution) mixed with 20 cc 0.25% bupivacaine in one syringe resulting in 364 µgm/cc for injection in perineural space. One time dose during nerve block preoperatively.
16181062|NCT01538459|Drug|Bupivacaine|Control Group receives 20 cc 0.25% bupivacaine without any adjuvants
16181063|NCT01538446|Drug|Modification of Prasugrel based on a biological assay|Monitoring with VerifyNow P2Y12, 2 weeks after initiation of 5 mg of maintenance dose of prasugrel, reduction of antiplatelet therapy if there is high on-treatment platelet inhibition (HPI) or increase in dosing if there is high on-treatment platelet reactivity (HPR) Device: VerifyNow point of care assay VerifyNow (ACCUMETRICS San Diego USA)
16181065|NCT01538446|Device|Verify Now|Monitoring with VerifyNow P2Y12, 2 weeks after initiation of 5 mg of maintenance dose of prasugrel, reduction of antiplatelet therapy if there is high on-treatment platelet inhibition (HPI) or increase in dosing if there is high on-treatment platelet reactivity (HPR) Device: VerifyNow point of care assay VerifyNow (ACCUMETRICS San Diego USA)
16181066|NCT01538420|Drug|GLPG0492|Oral solution
16181067|NCT01538420|Drug|Placebo|Placebo oral solution
16181068|NCT01538407|Other|Strength Training|The exercises will be performed in standard strength training equipment. Prior to each of the strengthening exercise sessions, a warm up phase is performed by 5-10 minutes of ergometer cycling at a moderate intensity. Muscle strengthening exercises will be performed according to the standard progressive resistance and overload principle. The exercise programme consists of three exercises performed with three sets of 10 repetitions at 60%-85% of patient's 10RM. Training load will be progressed by means of bi-weekly estimates of muscle strength to ensure a constant load of 60%-85% RM. Exercises are: 1. Leg extension, 2. Leg press, and 3. Forward lunges.
16181069|NCT01538394|Drug|Varenicline|
16181070|NCT01538394|Drug|Nicotine patches|
16181071|NCT01538394|Drug|Placebo (nicotine patches)|
16181072|NCT01538381|Drug|Afatinib|Afatinib for 2 weeks at a dose of 40 mg/day
16181073|NCT01538381|Other|Observation|Observation
16181074|NCT01538355|Other|Prolonged Fasting|Patients enhance their regular diet with an initial 7-day fasting episode.
16181075|NCT01538355|Other|Ketogenic low glycemic load treatment|6 months of ketogenic low glycemic load treatment from the study outset.
16181076|NCT01538355|Other|Control diet|Patients stay on their regular diet.
16181077|NCT01538342|Other|3 Biopsies|3 biopsies: 2 lesional and 1 non-lesional
16181078|NCT01538342|Other|2 biopsies|
16181079|NCT01538342|Other|biopsy|1 biopsy ok healthy skin
16181080|NCT01538329|Drug|Amantadine|200mg / day once daily in the morning and at noon - oral administration -
16181081|NCT01538329|Drug|placebo|200mg / day once daily in the morning and at noon - oral administration -
16181082|NCT01538316|Dietary Supplement|Quercetin supplement|500 mg/d quercetin (+ vitamin C + folic acid + vitamin B3) over a period of six months; crossover design (6 month-periods): followed by genistein and placebo supplement.
16181083|NCT01538316|Dietary Supplement|Genistein supplement|100 mg/d genistein (+ vitamin C + folic acid + vitamin B3) over a period of six months; crossover design (6 month-periods): followed by placebo and quercetin supplement.
16181084|NCT01538316|Dietary Supplement|Placebo|vitamin C + folic acid + vitamin B3 over a period of six months; crossover design (6 month-periods): followed by quercetin and genistein supplement.
16181085|NCT01538277|Procedure|Contact Force during ablation|Radio Frequency Ablation procedure with real-time contact force information known to the operator
16181086|NCT01538277|Other|Standard ablation procedure|Standard ablation procedure
16181087|NCT01538251|Drug|Propionyl-L-Carnitine|Modified release tablets containing 500 mg of propionyl-L-carnitine. one tablet twice a day.
16181088|NCT01538251|Drug|Placebo|Tablets containing 500 mg of propionyl-L-carnitine. one tablet twice a day.
16181089|NCT01538238|Drug|pazopanib|pazopanib 800mg qd until progression or unacceptable toxicity
16181090|NCT01538225|Drug|Sativex®|"THC:CBD 1:1 ratio oromucosal spray. A titration period is required to reach optimal dose. The number and timing of sprays may vary between patients.
~Duration: 2 weeks"
16181091|NCT01538225|Drug|Placebo|"Placebo
~Same frequency and dosage form as Sativex.
~Duration: 2 weeks"
16181092|NCT01538199|Device|Near-infrared radiation via Transcranial LED Therapy|"The subject will lie down comfortably on a exam bed . The sites of application of TLT (left and right forehead) will be inspected for any skin lesions (e.g. laceration or signs of inflammation) which would contraindicate the treatment. The subject will wear protective eyewear in the form of goggles or eye pads.
~The staff administering the TLT will be careful not to shine the light in or near the eyes of the subject. The two OLS devices will be secured in position with the use of a Hair Net. The delivery of the TLT is expected to last 20 min total (simultaneous application on the left and right forehead). The subject will be asked to rest for five minutes after the delivery of TLT. The skin at the sites of the application will be inspected again prior to dismissing the subject."
16181093|NCT01538199|Device|Sham device|The sham device does not emit near-infrared radiation.
16181094|NCT01538173|Drug|250ml HES 6%|Application twice a day 250ml HES 6% for three days postoperatively.
16181095|NCT01538173|Drug|9% NaCl 500ml|Application twice a day 500ml 9% NaCl for three days postoperatively.
16181096|NCT01538160|Drug|recombinant factor VIIa|single dose of 20ug/kg of recombinant factor VIIa along with tranexamic acid of 4 gram a day for 7 days following surgery
16181097|NCT01538108|Device|PTA Balloon catheter with paclitaxel|patients treated by the NMB's PTA Balloon catheter with paclitaxel
16181098|NCT01538108|Procedure|Plain Balloon angioplasty (PBA)|PBA
16181099|NCT01538095|Procedure|Dynamic Contrast-Enhanced Magnetic Resonance Imaging|Correlative studies
16181100|NCT01538095|Other|Laboratory Biomarker Analysis|Correlative studies
16181101|NCT01538095|Other|Pharmacological Study|Correlative studies
16181102|NCT01538095|Biological|Trebananib|Given IV
16181103|NCT01538069|Other|Exercise training|It consisted of three sessions/week, on non-consecutive days. The aerobic protocol consisted of a warm-up (strengthening exercises, 10 minutes), aerobic exercise (30 minutes in the first month and 45 minutes in the last two months) and cool-down (strengthening exercises, 10 minutes). The aerobic exercise intensity was established by heart rate levels that corresponded to anaerobic threshold, 10 heart rates down and 10 heart rates up, assessed by cardiopulmonary exercise testing. The strength training consisted of eight exercises attending the major muscle groups and the intensity was determined by 50-60% of one-repetition maximum (1-RM) and the progression of the training will be monthly: first month (a series of 12 repetitions with 50% 1-RM), second month (1 set of 15 repetitions with 60% 1-RM) and third months (2 sets of 10 repetitions with 60% 1-RM).
16181104|NCT01538069|Other|CPAP group|The CPAP treatment will be according to protocol of the Department of Psychobiology. Titration will be perform after randomization with ventilation device servo-assisted so as to ensure positive pressure within the first 24 hours of treatment. The treatment will be for three months.
16181105|NCT01538069|Other|Exercise and CPAP group|The patients randomized for this group will perform both Exercise protocol and CPAP treatment at the same time for three months.
16181106|NCT01538056|Device|Fenestrated Endovascular Graft|Modified endovascular graft with fenestrations to allow for blood flow to vital visceral vessels such as the renal arteries and SMA (Superior Mesenteric Artery).
16181107|NCT01538043|Other|local mud-pack therapy and balneotherapy|local mud-pack therapy and thermal-mineral bath at Chianciano Terme Spa Center (Siena, Italy) for a total of 12 applications carried out over a period of two weeks
16181108|NCT01538017|Drug|Xiapex|Collagenase Clostridium Histolyticum
16181109|NCT01538017|Procedure|Percutaneous needle fasciotomy|Percutaneous needle fasciotomy ad modum Lermusiaux and Debeyre
16181110|NCT01537991|Radiation|Radiotherapy|All patients will receive radiotherapy to the primary lung tumour and any demonstrated nodal involvement. Patients will be given radiotherapy of a dose between 58 and 65Gy in 20 fractions. Dose will be determined by the patients' group.
16181111|NCT01537978|Other|Video gaming for enhanced function after spinal cord injury.|Spinal cord injured indviduals will play Nintendo Wii sports games for an 8 week period.
16181112|NCT01537965|Device|Fibroscan® of Echosens, Aixplorer® of Supersonic Imagine, Aplio XG of Toshiba, QRS software developed by Pr I.Bricault, Acuson S2000 of Siemens|"Five ultrasounds exams are realised:
~elastography with Fibroscan®
~ultrasound elastography in supersonic mode with Aixplorer®
~ultrasound analysis of the surface liver with QRS software,
~quantification of acoustic structure with Aplio XG,
~elastography ARFI with Acuson S2000."
16181113|NCT01537939|Behavioral|ASUKI Step Worksite Pedometer Intervention|The intervention required participants to accumulate 10,000 steps each day for six months, with a 3-month follow-up period. Steps were recorded onto a study-specific website. Participants completed a website-delivered questionnaire four times to identify socio-demographic, health, psychosocial and environmental correlates of study participation. One person from each team at each university location was randomly selected to complete physical fitness testing to determine their anthropometric and cardiovascular health and to wear an accelerometer for one week.
16181114|NCT01537926|Drug|N-acetylcysteine|NAC 600mg capsule or matching Placebo , 1 twice daily for 90 days, then increase to NAC 1,200mg or matching placebo, 2 capsules twice daily for 270 days.
16181115|NCT01537926|Drug|Placebo|sugar pill manufactured to minic NAC 600mg capsule
16181116|NCT01537900|Drug|Grazoprevir|GZR 100 mg tablet by mouth q.d. for 7 days.
16181117|NCT01537887|Drug|LY2484595|Administered orally once daily for 10 days.
16181118|NCT01537887|Drug|Placebo|Administered orally once daily for 10 days.
16181119|NCT01537887|Drug|Moxifloxacin|Single dose administered orally.
16181120|NCT01537874|Behavioral|Motivational Interview|30 - 45 minutes in-person session to deliver results of nicotine air monitor and discuss home smoking ban using motivational interview techniques
16181121|NCT01537874|Behavioral|Usual best practices|Standard care delivered using informational materials
16181122|NCT01537861|Drug|Filgrastim|
16181123|NCT01537861|Drug|Bortezomib|
16181124|NCT01537861|Drug|Carfilzomib|
16181125|NCT01537861|Drug|Dexamethasone|
16181126|NCT01537861|Drug|Cyclophosphamide|
16181127|NCT01537861|Drug|Thalidomide|
16181128|NCT01537861|Drug|Lenalidomide|
16181129|NCT01537861|Drug|Pomalidomide|
16181130|NCT01537848|Procedure|EUS guided transmural drainage|Puncture of the collection is done under EUS guidance using a linear echoendoscope (FG-3830UT, Pentax or Olympus GF-UCT140/180 or forward viewing scope (Olympus)) with a 19G echoTip needle or a cystotome (Cook Medical Inc.). Then a 0.035 guidewire is inserted in the collection and the hole is enlarged with a cystotome (Cook Medical) or a 6.5F diathermic sleeve (Endoflex) and sometimes if needed a 6-8mm CRE balloon (Boston Scientific) before stenting with one or two double pigtail plastic stents (Cook Endoscopy, Endoflex). A nasocystic drain was also put whenever needed. If only a single stent could be placed in the first attempt, a subsequent procedure is scheduled for insertion of additional stents after dilation of the tract. There isn't any specific drug given during the procedure.
16181131|NCT01537835|Other|Antimicrobial Scrubs|Participants will be randomized to one of three types of scrubs. There will be a control (standard scrubs without antimicrobial properties) and two scrubs with reported antimicrobial properties.
16181132|NCT01537822|Procedure|Hysteroscopic morcellator|Morcellation will be performed with the HM (TRUCLEAR, Smith & Nephew, Andover, USA). The rotary blade is used for polypectomy and removal of residual placental tissue; the reciprocating blade is used for myomectomy. The blade has a window-opening at the end with cutting edges through which tissue is aspirated by means of a vacuum source. The removed tissue is discharged through the device, collected in a pouch and made available for pathology analysis.
16181133|NCT01537822|Procedure|Resectoscope|Resectoscopy will be performed with a rigid 8.5 mm bipolar resectoscope (Karl Storz GmbH, Tuttlingen, Germany), equipped with a 0 or 30 degree optic. Normal saline is used for distension and irrigation of the uterine cavity. Fluid balance is closely monitored using a Hystero pump (Richard Wolf GmbH, Knittlingen, Germany) or Hysteromat pump (Karl Storz GmbH, Tuttlingen, Germany).
16181134|NCT01537809|Dietary Supplement|Vitamin D3|Subjects are told to take vitamin D daily for 6 months.
16181135|NCT01537809|Dietary Supplement|Vitamin D3|Subjects are asked to take vitamin D orally, daily for six months.
16181136|NCT01537796|Behavioral|In-Person weight loss|Participants will attend weekly group intervention meetings. These sessions will address barriers associated with altering physical activity participation and dietary intake. Group discussions will be facilitated by the interventionist and interactive participation will be encouraged. Participants will be provided with written materials at each meeting to supplement group discussions. Paper diaries will be provided each week to assist participants with self-monitoring of calorie and fat consumption, and physical activity minutes and intensity. Participants will return the diary to the intervention staff each week for review and constructive feedback.
16181137|NCT01537796|Behavioral|FIT weight loss|Intervention materials will be provided and mailed weekly to participants. Participants will be provided with the BodyMedia® FIT System that includes a wearable device to monitor physical activity and energy expenditure, a display device to provide feedback on achievement of energy expenditure and physical activity goals, and web-based software to assist with self-monitoring of dietary intake and to provide feedback on goal achievement. Participants will attend one introductory session in which a tutorial of the components of the enhanced FIT System will be provided. Participants will receive a one-hour lesson on basic guidelines of the weight loss intervention. Once per month participants will receive a scheduled 10 minute intervention telephone call with the intervention staff.
16181138|NCT01537796|Behavioral|FIT-BT weight loss|Participants will be provided with intervention materials that are mailed weekly to them. Participants will be provided with the enhanced BodyMedia® FIT System that includes a wearable device with Bluetooth® technology to allow participants to receive real-time feedback on calories expended and physical activity on their smart phone. This also supports self-monitoring of dietary behaviors and body weight. Participants will attend one introductory session in which a tutorial of the components of the enhanced FIT System will be provided. Participants will also receive a one-hour lesson on basic guidelines of the weight loss intervention. Once per month participants will receive a scheduled 10 minute intervention telephone call with the intervention staff.
16181139|NCT01537783|Drug|Chlorhexidine gluconate|Scrubs applied once a day for 5 days
16181140|NCT01537783|Drug|Mupirocin|Nasal mupirocin applied topically to both nostrils twice a day for 5 days
16181141|NCT01537770|Procedure|Percutaneous vertebroplasty|Using fluoroscopic guidance, the practitioner infiltrates the skin and subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae with 1% lidocaine and infiltrates the periosteum of the pedicles with 0.25% bupivacaine (marcaine). 11-gauge or 13-gauge needles are passed into the central aspect of the target vertebra or vertebrae. Bone cement is prepared on the bench and injected under constant fluoroscopy into the vertebral body. Injection is stopped when the PMMA reaches to the posterior aspect of the vertebral body or leaks into an extraosseous space, such as the intervertebral disk or an epidural or paravertebral vein.
16181142|NCT01537770|Procedure|Lidocaine injection|Using fluoroscopic guidance, the practitioner infiltrates the skin and subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae with 1% lidocaine and infiltrates the periosteum of the pedicles with 0.25% bupivacaine (marcaine). 11-gauge or 13-gauge needles are passed into the central aspect of the target vertebra or vertebrae. 2 ml of 1% Lidocaine is injected in each needle. Bone cement is prepared on the bench simulating the vertebroplasty-procedure.
16181143|NCT01537757|Drug|MK-8931|Single dose, administered as oral capsules
16181144|NCT01537744|Drug|oral 5-azacitidine in combination with romidepsin|"DOSING REGIMEN(S):
~Table 1: Dose Escalation Schedule Dose Level Dose and Schedule a, c 5-Azacitidine (PO) Romidepsin (IV)
~Level -1b 100mg daily days 1-14 8mg/m2 days 8 and 15
~Level 1 200mg daily days 1-14 8mg/m2 days 8 and 15
~Level 2 300mg daily days 1-14 8mg/m2 days 8 and 15
~Level 3 300mg daily days 1-21 8mg/m2 days 8 and 15
~Level 4d MTD 8mg/m2 days 8, 15, and 22
~Each cycle will last 28 days.
~Subjects will be enrolled in Level -1 if the MTD is reached in the subjects enrolled in Level 1.
~On days when both agents are administered, oral 5-azacitidine should be administered at the start of the romidepsin infusion.
~Level 4 is optional and decisions whether to initiate this level will be based on discussions between the study investigator and Celgene."
16181145|NCT01537731|Procedure|vaginal or laparoscopic hysterectomy|vaginal hysterectomy or laparoscopic hysterectomy
16181146|NCT01537718|Device|REPLY 200|REPLY 200 pacemaker
16181147|NCT01537705|Drug|Neuron012703 (Medical Food)|2 capsules twice daily for sixty days.
16181148|NCT01537692|Drug|BDP HFA Nasal Aerosol|BDP HFA Nasal 80mcg
16181149|NCT01537692|Drug|BDP HFA Nasal Aerosol|BDP HFA Nasal 320mcg
16181150|NCT01537692|Drug|BDP HFA Inhalation Aerosol (QVAR)|BDP HFA Oral 320mcg
16181151|NCT01537679|Behavioral|Kirtan Kriya meditation|Meditation will be taught to 20 caregivers and supervised by Helen Lavretsky, M.D during their first visit. Meditation Kirtan Kriya will be performed for 12 minutes every day at the same time of the day for 8 weeks. Compliance will be monitored during visits and by daily diaries that will be reviewed at each visit.
16181152|NCT01537679|Behavioral|Relaxation|Participants in the relaxation group will be asked to relax in a quiet place with eyes closed while listening to the music on the relaxation CD for 12 minutes every day at the same time for 8 weeks.
16181153|NCT01537666|Drug|AeroVanc|Vancomycin hydrochloride dry powder for inhalation
16181154|NCT01537666|Drug|IV vancomycin hydrochloride|Vancomycin hydrochloride solution for intravenous administration
16181155|NCT01537653|Drug|SAR231893 (REGN668)|Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection
16181156|NCT01537653|Drug|placebo|Pharmaceutical form:Solution in a vial Route of administration: Subcutaneous injection
16181157|NCT01537640|Biological|SAR231893 (REGN668) DP1|Pharmaceutical form:solution Route of administration: subcutaneous
16181158|NCT01537640|Biological|SAR231893 (REGN668) DP2|Pharmaceutical form:solution Route of administration: subcutaneous
16181159|NCT01537627|Other|Physical training|"Aerobic exercises (treadmill and cycloergometer): Initially, the intensity is targeted at 60% of maximal capacity and it increases weekly until 110% of maximal capacity. Exercises duration: at least, 20 minutes.
~Resistive exercises (multi gym station; muscle groups: biceps, triceps and quadriceps): Initially, the intensity is targeted at 70% of one maximum repetition (1RM) and it increases weekly until 121% of 1RM. Exercises duration: 3 sets of 8 repetitions. Both exercise training are performed 3 times per week during 6 months."
16181160|NCT01537627|Other|Physical training|Callisthenic and breathing exercises are performed during 1 hour, 3 times per week during 6 months. The exercises are divided in 7 different sets and the degree of difficulty of the exercises progresses according to the set.
16181161|NCT01537614|Drug|COLIMYCINE inhalation|2 MILLION UI
16181162|NCT01537614|Drug|COLIMYCINE injectable|2 MILLIONS UI
16181163|NCT01537601|Procedure|Circumcision|Circumcision
16181164|NCT01537601|Other|Antibiotic prophylaxis alone|Antibiotic prophylaxis alone
16181165|NCT01537588|Other|Autograft STG harvest from ACL-deficient leg|Semitendinosus-gracilis graft harvest is undertaken on same limb that is undergoing ACL reconstruction
16181166|NCT01537588|Other|Autograft harvest contralateral to ACL-deficient leg|Semitendinosus-gracilis graft harvest is undertaken on limb contralateral to that undergoing ACL reconstruction
16181167|NCT01537575|Biological|intravenous immunoglobulins|One course of Intravenous Immunoglobulins 0.4 g/kg/die for 5 consecutive days
16181168|NCT01537575|Biological|Saline solution|Placebo
16181169|NCT01537562|Other|Timing of IUC insertion|Patients randomised to early insertion had their IUC inserted on day 5-9 after mifepristone treatment while patients randomised to delayed insertion had the IUC insertion at about 3 to 4 weeks after mifepristone.
16181170|NCT01537549|Drug|alpha-lipoic acid and L-acetyl carnitine|alpha-lipoic acid and L-acetyl carnitine capsules, 600mg/1.5g daily for 6 months
16181268|NCT01536860|Other|Dietary Intervention|300 ml of liquid food product
16181171|NCT01537536|Drug|EndoTAG-1|EndoTAG-1 (22 mg/m2 liposomal paclitaxel) + Paclitaxel (70 mg/m2) Weekly i.v. infusions of EndoTAG-1 and paclitaxel for 12 weeks followed by subsequent treatment with the standard FEC regimen (Fluorouracil 500 mg/m2, Epirubicin 100 mg/m2, Cyclophosphamide 500 mg/m2) once every 3 weeks for 3 cycles of therapy followed by surgery.
16181172|NCT01537523|Procedure|community-care program|community nurse care, physiotherapy
16181173|NCT01537510|Behavioral|STAR - Study of Technology to Accelerate Research|In 14 pediatric practices, to conduct a cluster-randomized controlled trial to examine the extent to which computerized point of care decision alerts to pediatric primary care providers, with or without direct-to-parent communications, will increase adoption of comparative effectiveness research evidence on childhood obesity for children 6 to 12 years of age with a BMI ≥ 95th percentile.
16181174|NCT01537497|Drug|PF-05175157|One single oral dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM.
16181175|NCT01537497|Drug|PF-05175157|One single oral dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM.
16181176|NCT01537497|Drug|PF-05175157|One single oral dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM.
16181177|NCT01537497|Drug|Placebo|One single oral dose of placebo will be administered as a powder-in-capsule in the fasting state in the AM.
16181178|NCT01537484|Procedure|Massage Therapy|Swedish Massage for 1 hour for 8 weeks, Light Touch Bodywork for 1 hours for 8 weeks.
16181179|NCT01537471|Drug|Placebo|Placebo
16181180|NCT01537471|Drug|Meclizine|Meclizine 12.5 mg
16181181|NCT01537471|Drug|Meclizine|Meclizine 25 mg
16181182|NCT01537458|Procedure|follow-up of isolated tricuspid valve repair|follow-up of patients that underwent TV repair in the past.
16181183|NCT01537432|Drug|secukinumab|secukinumab
16181184|NCT01537432|Drug|placebo|placebo comparator
16181185|NCT01537419|Behavioral|Attachment-Based Family Therapy|Although ABFT therapists implement behavior focused and psychoeducational interventions, the model is primarily a process oriented, emotion focused treatment guided by a semi-structured treatment protocol. ABFT aims to improve the family's capacity for problem solving, affect regulation, and organization. This strengthens family cohesion which can buffer against depression, suicidal thinking, and risk behaviors.
16181186|NCT01537419|Behavioral|Family-Enhanced Non-directive Supportive Therapy|Family-Enhanced Non-directive Supportive Therapy (FE-NST) is a 16 week therapy designed to control for the non-specific effects of psychotherapy with suicidal youth. FE-NST aims toward relief or reduction of symptoms without expectation of change in the basic personality structure. We have added a parent component to: a) control for parent involvement and b) improve the generalizability and safety of the FE-NST treatment. This enhancement consists of 5 potential parent sessions beginning with a family safety plan in the initial treatment session that will be monitored regularly throughout the treatment. The remaining 4 parent psycho-education sessions offer parents knowledge, skills and support to improve management of the suicidal teen.
16181187|NCT01537406|Radiation|BREAST IRRADIATION USING INTENSITY-MODULATED RADIATION THERAPY|LONG TERM OUTCOMES OF A MULTICENTRE CONTROLLED CLINICAL TRIAL OF BREAST IRRADIATION USING INTENSITY-MODULATED RADIATION THERAPY
16181188|NCT01537393|Biological|Cornea tissue transplant|Cornea tissue preserved 0 to 7 days
16181189|NCT01537393|Biological|Cornea tissue transplant|Cornea tissue preserved 8 to 14 days.
16181190|NCT01537380|Drug|Cefazoline|Injection of CEFAZOLINE (4 grams) 30-60 min before skin incision. A second injection will performed every 4 hours during the surgery
16181191|NCT01537367|Behavioral|Enhanced contact plus behavioral skills|The enhanced contact plus behavioral skills arm is the longer experimental arm.
16181192|NCT01537367|Behavioral|Enhanced contact only|The enhanced contact only arm is the shorter experimental arm.
16181193|NCT01537367|Behavioral|Standard of Care|The standard of care arm is the comparison group arm that receives only standard clinical services.
16181194|NCT01537354|Drug|Curosurf®|Initial dose is 2.5ml/kg (200 mg/kg phospholipid) administered via endotracheal tube. Subsequent doses if needed are 1.25 mL/kg (100 mg/kg phospholipids).
16181195|NCT01537354|Drug|Survanta®|Initial dose is 4 mL/kg (100 mg/kg phospholipids) administered via endotracheal tube. Subsequent doses if needed are 4 mL/kg (100 mg/kg phospholipids).
16181196|NCT01537341|Behavioral|Traditional Treadmill|Participants will complete the intervention in 12-weeks, 3 times per week sessions.
16181197|NCT01537341|Behavioral|Split-belt|Participants will complete the intervention in 12-weeks, 3 times per week sessions.
16181198|NCT01537328|Other|Total knee replacement rehabilitation|After total knee arthroplasty, patients will be assigned to an outpatient rehabilitation clinic, based upon geography. Patients will be enrolled randomly into one of two rehabilitation programs (PROG or TRAD). Both rehabilitation programs will take place over 12 weeks. Both groups will receive treatment for range of motion, activities of daily living and gait training, as well as a home exercise program.
16181199|NCT01537315|Drug|Hydroxychloroquine|200 mg capsule daily for 10 +/- 4 days, then 200 mg twice daily till end of study (duration approximately 6 months)
16181200|NCT01537315|Other|Matching Placebo|matching placebo capsule 200 mg daily for 10 +/- 4 days and thereafter 200 mg twice a day for duration of study, approximately 6 months
16181201|NCT01537302|Device|CTO crossing in femoropopliteal arteries CONNECT II|CTO crossing in femoropopliteal arteries using the Ocelot System
16181202|NCT01537289|Device|Pigtail catheter insertion (Cook)|insertion of pigtail catheter to decompress pneumothorax
16181203|NCT01537289|Device|chest tube (28-French)|inserting chest tube to decompress pneumothorax
16181204|NCT01537276|Procedure|diagnose under real-time fluoroscopy|radiologists evaluating the tubal patency under fluoroscopy real-timely.Findings of fluoroscopy were blind to the investigators when the static radiographs were re-analyzed by the same team of radiologists.
16181205|NCT01537263|Device|Ultrasound Perfusion Imaging|Sonographic unit Phillips IU 22, 5ml SonoVue ultrasound contrast agent per examination, Duration: 1h
16181206|NCT01537250|Drug|Levofloxacin 500 mg placebol|oral form,,once adily,7~10 days
16181207|NCT01537250|Drug|Levofloxacin 500 mg placebol|oral form,,once adily,7~10 days
16181208|NCT01537250|Drug|Nemonoxacin 3 tablets|oral form,once daily,7~10 days
16181269|NCT01536860|Other|Dietary Intervention|300 ml of liquid food product
16181270|NCT01536860|Other|Dietary Intervention|300 ml of liquid food product
16181209|NCT01537224|Other|Measure of the electrophysiological activity of the subthalamic nucleus|Local field recording of the subthalamic nucleus by mean of externalized electrodes in the immediate postoperative periode.
16181210|NCT01537211|Device|C leg compared to subject's mechanical leg (Otto Bock)|comparison of different prosthetic knees
16181211|NCT01537211|Device|C leg compared to subject's mechanical leg (Otto Bock)|comparison of different prosthetic knees
16181212|NCT01537185|Other|Placebo|3 cohorts of normal saline injection
16181213|NCT01537185|Biological|SPWCV+Alum 100 mcg|3 injections 28 days apart
16181214|NCT01537185|Biological|SPWCV+Alum 600 mcg|3 injections 28 days apart
16181215|NCT01537185|Biological|SPWCV+Alum 300 mcg|3 injections 28 days apart
16181216|NCT01537172|Drug|ONO-4053|Part A: ONO-4053 doses proposed are 10 mg, 30 mg, 100 mg, 300 mg, 600 mg, 900 mg as a single dose administered by mouth once daily, depending on the outcome of the previous dose.
16181217|NCT01537172|Drug|Placebo|Placebo to match ONO-4053 tablets, dosed in a similar manner to ONO-4053
16181218|NCT01537159|Device|3 Tesla (3T) Siemens Total imaging matrix (TIM) Trio whole-body system|Each MR scanning session will include the pre-contrast multi-slice T2-weighted MRI with fat-saturation and T1-weighted MRI which are regularly acquired in clinical protocols. Following these acquisitions, high-spatial and temporal-resolution DCE-MRI will be performed. The total duration of a research MR session is expected to be less than 45 min.
16181219|NCT01537146|Drug|Ropivacaine|Bolus infusion via catheter/6H for 24H
16181220|NCT01537146|Drug|Ropivacaine|Intra operational bolus infusion. Bolus infusion via catheter /6H for 24H
16181221|NCT01537133|Drug|fluticasone|Dry Powder Inhaler: 250 mcg/puff, one puff, twice a day
16181222|NCT01537133|Drug|Placebo|Dry Powder Inhaler: Placebo
16181223|NCT01537120|Drug|Vildagliptin|
16181224|NCT01537120|Drug|Placebo|
16181225|NCT01537107|Drug|vismodegib|Given PO
16181226|NCT01537107|Drug|sirolimus|Given PO
16181227|NCT01537107|Procedure|positron emission tomography|Correlative studies
16181228|NCT01537107|Procedure|computed tomography|Correlative studies
16181229|NCT01537107|Other|pharmacological study|Correlative studies
16181230|NCT01537107|Other|laboratory biomarker analysis|Correlative studies
16181231|NCT01537107|Radiation|fludeoxyglucose F 18|Correlative studies
16181232|NCT01537094|Dietary Supplement|Placebo|
16181233|NCT01537094|Dietary Supplement|Vitamin C 250 mg once daily|
16181234|NCT01537094|Dietary Supplement|Vitamin C 1,000 mg once daily|
16181235|NCT01537081|Drug|Mucinex|Mucinex combines immediate-release (IR) and modified-release guaifenesin in a bilayer tablet. Each tablet was 600 mg of guaifenesin and taken by mouth with a full glass of water.
16181236|NCT01537081|Drug|Immediate-release Guaifenesin|Each tablet was 200 mg of immediate-release (IR) guaifenesin and taken by mouth with a full glass of water.
16181237|NCT01537081|Drug|Placebo|Placebo tablets in two formulations to match either Mucinex or IR guaifenesin taken by mouth with a full glass of water
16181238|NCT01537068|Drug|Desvenlafaxine|Desvenlafaxine oral dose ranging from 50 to 100 mg/day
16181239|NCT01537068|Drug|Placebo|Matching placebo pills
16181240|NCT01537055|Drug|levofloxacin-based sequential therapy|levofloxacin-based sequential therapy for 10 days〔lansoprazole 30mg and amoxicillin 1g for the first 5 days, followed by lansoprazole 30mg, levofloxacin 250mg, and metronidazole 500mg for another 5 days (all given twice daily)〕
16181241|NCT01537055|Drug|levofloxacin-based triple therapy for 10 days|lansoprazole 30mg and amoxicillin 1g, and levofloxacin 250mg for 10 days (all given twice daily)
16181242|NCT01537042|Drug|Rotigotine|"Transdermal patch; Dose: 1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h.
~Subjects start with a Rotigotine dose of 1 mg/24 h for 1 week. The dose can be increased weekly during Up-Titration Period until either the optimal or the maximal dose of 3 mg/24 h has been reached. Subjects will maintain the optimal/maximal dose during the 2-week Maintenance Period. Following the Maintenance Period, subjects will be de-escalated from their optimal dose by decreasing the dose by 1 mg/24 h every other day during Taper Period until complete withdrawal."
16181243|NCT01537042|Drug|Placebo|"Transdermal patch; Patches matching to active treatment patches in size and appearance.
~Up to 3 weeks of Titration,
~2 weeks of Maintenance,
~Up to 4 days of Taper Period."
16181244|NCT01537029|Drug|Doxorubicin|Dosed by the patient's treating physician according to local standard of care.
16181245|NCT01537029|Drug|Cyclophosphamide|dosage form: IV, Dosage, frequency, and duration: According to local standard of care
16181246|NCT01537016|Device|PROMOGRAN|PROMOGRAN® is a protease modulating dressing, formulated as a bioresorbable amorphous open-pored matrix constructed of 45% oxidised regenerated cellulose (ORC) and 55% bovine collagen
16181247|NCT01537016|Device|Tielle|Tielle is a hydropolymer foam dressing that is designed to provide optimal wound healing
16181248|NCT01537003|Device|Promogran|Promogran is a collagen/ORC dressing which modulates the wound environment
16181249|NCT01537003|Device|Coban 2 layer|Compression bandage
16181250|NCT01536977|Other|quality-of-life assessment|Ancillary studies
16181251|NCT01536977|Other|questionnaire administration|Ancillary studies
16181252|NCT01536977|Behavioral|management of therapy complications|Undergo BBT-I
16181253|NCT01536977|Behavioral|cognitive assessment|Ancillary studies
16181254|NCT01536977|Behavioral|educational intervention|Undergo BBT-I
16181255|NCT01536964|Drug|morphine|2.5mg of morphine will be given post Prasugrel administration with a further 2.5mg 5 minutes later
16181256|NCT01536964|Drug|saline|2.5ml of saline will be given post Prasugrel followed by a further 2.5ml as a comparator for the morphine
16181257|NCT01536951|Drug|LY3009104|administered orally
16181258|NCT01536951|Drug|Placebo|Administered orally
16181259|NCT01536951|Drug|moxifloxacin|Administered orally
16181260|NCT01536938|Drug|LEO 90100|
16181261|NCT01536938|Drug|Calcipotriol|
16181262|NCT01536938|Drug|Betamethasone|
16181263|NCT01536886|Drug|LEO 90100|
16181264|NCT01536886|Drug|Betamethasone plus calcipotriol|
16181265|NCT01536886|Drug|Ointment vehicle|
16181266|NCT01536886|Drug|LEO 90100 vehicle|
16188663|NCT01481493|Biological|Placebo|subcutaneous injection of placebo
16181271|NCT01536847|Other|Dietary Intervention|300 ml of liquid food product
16181272|NCT01536847|Other|Dietary Intervention|300 mL of liquid food product
16181273|NCT01536847|Other|Dietary Intervention|300 ml of liquid food product
16181274|NCT01536834|Device|Medical Device|
16181275|NCT01536808|Other|Cardiac RMI|Cardiac RMI
16181276|NCT01536808|Other|Analysis telomere|Analysis telomere
16181277|NCT01536808|Other|Stress test|Stress test
16181278|NCT01536808|Other|echocardiography|echocardiography
16181279|NCT01536795|Drug|WR279,396 with Tegaderm Dressing|Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days with polyurethane dressing
16181280|NCT01536795|Drug|WR 279,396 with Gauze and Tape Dressing|Ointment containing paromomycin sulphate (15%) and gentamicin sulphate (0.5%) - in a base (AQIC)applied for 20 days
16181281|NCT01536782|Procedure|Bolus|"The patients will be randomized into 3 different groups: Bolus, Gravity, and Pump. The randomization process will be based on age and estimated caloric needs (i.e if we have three 60-year-old patients whose estimated kcals needs are ≤ 1900kcals/day, then each patient will be randomized to either of the groups).
~Each patient from each group will be receiving tube feeding education to their by RD. For consistency reasons, the same type of tube feeding formula (1.5 kcal/ml, no fiber) will be used. Patients' weight, tube feeding tolerance, and amount of estimated calories and protein met will be monitored weekly."
16181282|NCT01536782|Procedure|Gravity|"The patients will be randomized into 3 different groups: Bolus, Gravity, and Pump. The randomization process will be based on age and estimated caloric needs (i.e if we have three 60-year-old patients whose estimated kcals needs are ≤ 1900kcals/day, then each patient will be randomized to either of the groups).
~Each patient from each group will be receiving tube feeding education to their by RD. For consistency reasons, the same type of tube feeding formula (1.5 kcal/ml, no fiber) will be used. Patients' weight, tube feeding tolerance, and amount of estimated calories and protein met will be monitored weekly."
16181283|NCT01536782|Device|Pump|"The patients will be randomized into 3 different groups: Bolus, Gravity, and Pump. The randomization process will be based on age and estimated caloric needs (i.e if we have three 60-year-old patients whose estimated kcals needs are ≤ 1900kcals/day, then each patient will be randomized to either of the groups).
~Each patient from each group will be receiving tube feeding education to their by RD. For consistency reasons, the same type of tube feeding formula (1.5 kcal/ml, no fiber) will be used. Patients' weight, tube feeding tolerance, and amount of estimated calories and protein met will be monitored weekly."
16181284|NCT01536756|Other|Exercise Intervention -- Physical Rehabilitation Program|"The intervention group will participate in a Physical Rehabilitation Program which includes a 60-minute training session at a frequency of 3 times a week over a total of 12-week duration. The training session consists of 45 minutes of warm-up stretching and circuit training. This includes 3 stations of aerobic exercises for physical work up of different body parts, and 3 stations of strengthening exercises of major muscles groups at 3 sets of 10 repetitions. The final 15-minute training session will be the cooling down exercise with emphasis on stress management incorporating mindful breathing, stretching and body awareness exercise."
16181285|NCT01536756|Other|Wait List Control Group|The subjects of the control group will be asked to maintain their usual activities while awaiting for the physical rehabilitation program at the 12-week waiting time. They will be allowed to receive any other usual medical services including social services and psychotherapy but not physiotherapy services. At the end of the 3rd month, the control group will be recruited into the Physical Rehabilitation Program. Patients in the control group will then join in as the intervention group and follow the intervention and assessment protocol.
16181286|NCT01536743|Drug|PD0332991|"30 patients with recurrent ovarian epithelial carcinoma demonstrating Rb-proficiency and absent or low expression of p16 will be registered to receive PD0332991 once a day by mouth in the morning on an empty stomach.
~PD0332991 will be administered daily for 3 weeks followed by 1 week off treatment (28 day cycle)."
16181287|NCT01536730|Behavioral|Homework Intervention Strategy|"Participants assigned to intervention will receive a condom ditty bag containing 50 condoms (5 each of 10 types), a variety of 50 lubricants, an instructional DVD, and instructions for the intervention."
16181288|NCT01536717|Drug|Articaine hydrochloride 2% solution|"4 ml/h periosteal wound infusion
~duration of 72 h"
16181289|NCT01536717|Drug|Sodium Chloride|Placebo Sodium chloride 0,9%
16181290|NCT01536704|Drug|Nicotine (2 mg)|2 mg nicotine lozenge in two formulations
16181291|NCT01536704|Drug|Nicotine (4 mg)|4 mg nicotine lozenge in two formulations
16181292|NCT01536691|Drug|ramosetron|ramosetron 0.3 mg iv D1 aprepitant 125 mg po D1, 80 mg po D2, 80 mg po D3 dexamethasone 12 mg po D1, 8 mg po D2-4
16181293|NCT01536691|Drug|ondansetron|ondansetron 16 mg iv D1 aprepitant 125 mg po D1, 80 mg po D2, 80 mg po D3 dexamethasone 12 mg po D1, 8 mg po D2-4
16181294|NCT01536678|Drug|Levothyroxine|Single dose of 600mcg of test formulation of levothyroxine administered in dosing period 1 or 2.
16181295|NCT01536678|Drug|Levothyroxine|Single dose of 600mcg of reference formulation of levothyroxine administered in dosing period 1 or 2.
16181296|NCT01536665|Drug|liraglutide|Administered subcutaneously (s.c., under the skin) once daily for 4 weeks.
16181297|NCT01536665|Drug|placebo|Administered subcutaneously (s.c., under the skin) once daily for 4 weeks.
16181298|NCT01536652|Drug|biphasic insulin aspart 30|Prescription at the discretion of the treating physician
16181299|NCT01536639|Drug|biphasic insulin aspart 30|Administered by subcutaneous injection. The physician determined the starting dose and frequency, as well as later changes to either dose or frequency, if any
16181300|NCT01536626|Drug|biphasic insulin aspart 30|Prescription at the discretion of the treating physician
16181301|NCT01536613|Drug|biphasic insulin aspart 30|The insulin dose and regimen were individualised at the physician's discretion. Insulin was administered by subcutaneous injection using an injection device
16181302|NCT01536600|Drug|biphasic insulin aspart 30|The insulin dose and regimen was individualised at the physician's discretion
16181327|NCT01536418|Drug|GSK1605786A|500 milligrams once daily, orally administered for 12 weeks
16181328|NCT01536418|Drug|GSK1605786A|500 milligrams twice daily, orally adminstered for 12 weeks
16181329|NCT01536405|Biological|MMRV (AMP)|Measles, mumps, rubella, and VZV vaccine made with an alternative manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.
16181303|NCT01536587|Drug|Salmeterol|At visit 1 the sympathetic activity will be registered using microneurographic recordings of efferent muscle sympathetic nerve activity (MSNA) in the peroneal nerve and respiration over 2 hours, after 20 minutes of recording, 1 dose of placebo will be administered and after a further recording period of 45 minutes a dose of salmeterol 50 µg will be administered which will be followed by a further period of data registration. At visit 2 following 4 weeks of inhaled treatment with salmeterol the same procedures will be performed but a placebo inhalation will not be performed.
16181304|NCT01536574|Drug|Requip PR|Eligible patients will be dispensed medication to uptitrate their REQUIP PR dose (2, 4, 6, 8mg respectively) during the first 4 weeks of treatment. During the 24 week treatment phase, the subjects dose will be adjusted according to the recommended schedule to achieve symptomatic control.
16181305|NCT01536561|Biological|Radiolabeled Monoclonal Antibody Anti-B1 for the Treatment of B-Cell Lymphomas (Tositumomab and Iodine I 131 Tositumomab)|131-I anti-B1 is the product of 131-I labeling of the anti-CD20 murine monoclonal antibody and the anti-B1 antibody itself is an intact IgG2a murine monoclonal antibody which has specificity far the CD20 antigen on human B cells. Anti-B1 is a clear, colorless liquid. 131-I labeling of the anti-B1 antibody will be carried out by iodogen technique. Trace labeling of the antibody will involve the labeling of approximately 1 to 3 mg of antibody with 5 mCi of 131-I.
16181306|NCT01536548|Procedure|Skin drawing|Mark direction and angle for cannulation with a pencil on the skin
16181307|NCT01536548|Procedure|No skin drawing|Standard practice; i.e. no marks on skin to help find correct direction and angle for introducing needles
16181308|NCT01536535|Drug|Mesalazine|Mesalazine (Pentasa) comes in 500mg capsules, and doses will need to be rounded to the nearest 500mg increment, with a maximum dose of 76 mg/kg/day. The average dose for the pediatric population will be approximately 70 mg/kg/day. Patients will be allowed to escalate to the final dose over 4 days to minimize side-effects such as headache.
16181309|NCT01536535|Drug|IV Corticosteroid|Treatment with IV Corticosteroid
16181310|NCT01536535|Drug|Oral Corticosteroids|Treatment with oral corticosteroids
16181311|NCT01536535|Other|Additional Therapies|Anti-TNFα, Calcineurin inhibitor, Immunomodulator
16181312|NCT01536535|Procedure|Colectomy|Colectomy
16181313|NCT01536522|Dietary Supplement|Nutritional approach for asthma|participants will be provided a medium chain triglyceride supplement or placebo
16181314|NCT01536522|Dietary Supplement|Low Caloric Shake|participants will be provided a low caloric dietary shake
16181315|NCT01536522|Biological|whole lung allergen challenge|inhalation of allergens by allergic patients with or without asthma, will be used to define mechanisms underlying the development of airway inflammation
16181316|NCT01536509|Behavioral|Telehealth Behavioral Treatment (TBT)|Families in the TBT condition will receive three individually-tailored behavioral intervention sessions in addition to the online education intervention with 1) guided problem-solving and behavior management training tailored to the unique needs and/or barriers of the family, and 2) discussion of the patient's adherence since the previous session. In addition, patients in the TBT condition will be signed up for text message reminder service offered free of charge via www.mymedschedule.com. These are generic reminder text messages are used to assist with adherence in adolescents. Intervention sessions will be conducted via telehealth delivery with trained postdoctoral psychology fellows or masters-level graduates using webcams, supplied by the study, and SkypeTM free software.
16181317|NCT01536509|Behavioral|Education Only (EO)|Families in the EO condition will receive three individual sessions in addition to the online education intervention to review 1) online educational intervention material to answer questions participants have, 2) educational brochures from the Crohn's and Colitis Foundation of America (CCFA), which contain additional information (e.g., Guide for Parents, Living with IBD, Guide for Kids and Teenagers), and 3) general healthy lifestyle recommendations (e.g., sleep, exercise, etc.). Sessions will be conducted via telehealth delivery with trained postdoctoral clinical psychology fellows or masters-level graduates using webcams, supplied by the study, and SkypeTM free software.
16181318|NCT01536496|Biological|Blood product transfusion based on conventional coagulation tests.|Transfusion of blood products.
16181319|NCT01536496|Biological|Blood product transfusion based on rapid thrombelastography (r-TEG) results.|Transfusion of blood products.
16181320|NCT01536483|Drug|Butyrate enemas|"Seven enemas
~Possibility to delay from 24 to 48 hours the procedure in case of clinical poor tolerance(maximum two enemas postponed and delayed at PND12 and PND13)
~The study remains blinded for the investigation team through the intervention of a clinical research nurse
~According to the procedure previously described by Nakaoka et al. (2009), a lubricated Foley catheter Ch 6 will be introduced into the rectum, the balloon will be inflated with 1 ml water for injections. Butyrate solution will be placed in a bag placed 50 cm above the child. Therefore, treatment administration will be performed at a controlled pressure of 50 cm H2O without any manual intervention
~Installation time and retention is setted at 15 minutes
~Treatment units will be directly placed in the incubator 30 min before the procedure to warm the enema to +36°C
~Per-treatment clinical monitoring of the tolerance will be performed by a neonatologist"
16181321|NCT01536470|Other|noradrenaline|The primary objective of the study is to compare two strategies of intraoperative blood pressure management in high-risk surgical patients: 1- Continuous infusion of noradrenaline to maintain arterial blood pressure of no more than 10% below its baseline value; 2- Conventional treatment of hypotension (defined as a blood pressure of below 80 mmHg or a decrease of more than 40% from baseline) using intravenous bolus of Ephedrine chorhydrate.
16181322|NCT01536470|Other|Ephedryne chorydrate|
16181323|NCT01536444|Device|Momelan Technologies Epidermal Graft Harvesting System|The procurement of the epidermal micrograft involves the use of the MoMelan Technologies suction blister system which consists of a control box that creates the vacuum necessary to create the microblisters and a harvester. The device is applied to the subject's thigh to create blisters. The epidermal micrografts are then harvested and transferred to Tegaderm™ and then placed on the surgical wound and the wound is bandaged.
16181324|NCT01536431|Drug|Pro insulin peptide|Patients will receive 10 micro gr of the peptide every 2 weeks (12 doses).
16181325|NCT01536431|Drug|Pro insulin peptide|Patients will receive 10 micro gr of the peptide monthly (ever 4 weeks, 6 doses) and saline injections monthly alternating with the peptide (2 weeks interval between the drug and saline).
16181326|NCT01536431|Drug|Saline|Patients will receive 0 micro gr of peptide, but have saline injections every 2 weeks (controls).
16189280|NCT01477021|Biological|NY-ESO-1-specific T cells|Given IV
16181330|NCT01536405|Biological|MMRV (2006 process)|Measles, mumps, rubella, and VZV vaccine made with the 2006 manufacturing process. Participants will receive two 0.5 mL subcutaneous injections.
16181331|NCT01536392|Drug|Granisetron|34.3 mg of granisetron formulated in a transdermal patch replaced every 7 days. At cycle 1, participants receive granisetron by vein prior to IV cisplatin and prior to administration of transdermal patch.
16181332|NCT01536392|Drug|Ondansetron|8 mg of ondansetron by mouth three times a day starting with cisplatin administration and continued for 72 hours after chemotherapy infusion.
16181333|NCT01536392|Behavioral|Questionnaires|Completion of 3 questionnaires at study visits taking about 5 minutes each time.
16181334|NCT01536392|Behavioral|Study Drug Diary|Study drug diary to record times that study drugs taken, and to record any nausea or vomiting experienced.
16181335|NCT01536379|Drug|Belimumab|Belimumab (10 mg/kg) will be given as an intravenous solution over a 1 hour time period administered every 4 weeks for 24 weeks (with an additional dose at Week 2)
16181336|NCT01536379|Drug|Placebo|Placebo will be given as an intravenous solution over a 1 hour time period administered every 4 weeks for 24 weeks (with an additional dose at Week 2)
16181337|NCT01536366|Drug|BIA 9-1067|25 mg BIA 9-1067 (single-dose)
16181338|NCT01536366|Drug|Repaglinide|0.5 mg repaglinide (single-dose)
16181339|NCT01536353|Drug|AGSAV301|tablet, q.d.
16181340|NCT01536353|Drug|Exforge 10/160|Tablet, q.d.
16181341|NCT01536314|Drug|Memantine EBIXA®|The aim of this study is to evaluate if memantine administered during 4 weeks beginning 2 weeks before surgery induces a decrease of painful intensity 3 months after surgery, compared to placebo group.
16181342|NCT01536314|Drug|Placebo : lactose|The aim of this study is to evaluate if memantine administered during 4 weeks beginning 2 weeks before surgery induces a decrease of painful intensity 3 months after surgery, compared to placebo group.
16181343|NCT01536301|Drug|Standard Care morphine hydrochloride|Post-operative analgesia including morphine (patient controlled analgesia).
16181344|NCT01536301|Drug|Oxycodone|Post-operative analgesia including oxycodone (patient controlled analgesia).
16181345|NCT01536288|Drug|Rhodiola crenulata|Rhodiola crenulata:capsules, 800 mg daily for 7 days before ascent and 2 days during mountaineering
16181346|NCT01536288|Drug|placebo|Placebo:capsules, 800 mg daily for 7 days before ascent and 2 days during mountaineering
16181347|NCT01536275|Other|Late parenteral nutrition|Withholding parenteral nutrition during the first 7 days of ICU stay
16181348|NCT01536262|Drug|Tiotropium + Olodaterol|Tiotropium and Olodaterol FDC once daily inhalation
16181349|NCT01536262|Device|Respimat|Respimat inhaler
16181350|NCT01536262|Drug|Tiotropium + Olodaterol|Tiotropium and Olodaterol FDC once daily inhalation
16181351|NCT01536262|Drug|Olodaterol|Olodaterol once daily inhalation
16181352|NCT01536262|Device|Respimat|Respimat inhaler
16181353|NCT01536262|Device|Respimat|Respimat inhaler
16181354|NCT01536249|Drug|Dexpramipexole|Single Oral Dose
16181355|NCT01536249|Drug|Cimetidine plus Dexpramipexole|Multiple Oral Doses
16181356|NCT01536236|Device|ANS Eon™ Implantable Pulse Generator (Permanent Implant)|Appropriate programming based on subject's preference of programs.
16181357|NCT01536236|Device|Placebo|Placebo
16181358|NCT01536223|Drug|PF (cisplatin and 5-fluorouracil) group|the group the patients using PF(cisplatin and 5-fluorouracil )neoadjuvant chemotherapy 3 cycles of neoadjuvant chemotherapy at day1,22 and 43 with cisplatin 100mg/m2 and 5-fluorouracil 4000mg/m2 civ 120 hours And then chemoradiation using IMRT with 2 cycles of cisplatin concurrent chemotherapy at 80mg/m2.
16181359|NCT01536223|Drug|TPF (docetaxel plus cisplatin and 5-fluorouracil) group|"3 cycles of TPF neoadjuvant chemotherapy at day1,22 and 43 with docetaxel 75mg/m2,cisplatin75mg/m2 and 5-fluorouracil 2400mg/m2 civ 96 hours .
~And then chemoradiation using IMRT with 2 cycles of cisplatin concurrent chemotherapy at 80mg/m2."
16181360|NCT01536210|Drug|YY-162|YY-162(Ginkgo extract 30mg + Ginseng extract 50mg) 1T/Three times a day(Tid) for 8 weeks, PO medication
16181361|NCT01536210|Drug|Placebo|Placebo 1T/ Three times a day (tid) for 8 weeks, PO medication
16181362|NCT01536197|Procedure|Gastric bypass|Roux-en-Y gastric bypass
16181363|NCT01536197|Procedure|Gastric banding|Laparoscopic adjustable gastric banding
16181364|NCT01536197|Procedure|Sleeve gastrectomy|Sleeve gastrectomy surgery
16181365|NCT01536184|Behavioral|Circle of Security (COS)|COS is a community based, visually supported, individualized attachment protocol appropriate for use with preschoolers and children and their parents/caregivers. It is based on attachment theory of John Bowlby and Mary Ainsworth and integrates neuroscientific principles of emotional regulation and attachment. The protocol contains both educational and therapeutic components. The goals of the intervention include increasing caregiver sensitivity and appropriate responsiveness to their child through increasing their capacity to recognize and understand their child's cues, and increasing caregiver self-reflection on their own caregiving behaviour.
16181366|NCT01536171|Other|running with normal running shoes and barefoot|shod condition: normal running shoes barefoot condition: running with no shoewear
16181367|NCT01536158|Drug|Oral paracetamol|Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours for 3 days.
16181368|NCT01536158|Drug|Oral ibuprofen|Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.
16181369|NCT01536145|Drug|CP-751,871|CP-751,871 was given at doses ranging from 0.025 mg/kg up to 20 mg/kg IV every 4 weeks until disease progression or lack of tolerability
16181370|NCT01536132|Drug|Levosimendan|0.2 micrograms/kg/min is administered intravenously without bolus for 6 hours every two weeks.
16181371|NCT01536132|Drug|Placebo|Placebo (same appearance than active drug) is administered with the same dosing regime
16181372|NCT01536119|Behavioral|Coparenting Breastfeeding Support Intervention|The intervention group will receive standard care offered to breastfeeding women in the hospital and community with the addition of a multifaceted coparenting breastfeeding support intervention, which will include an in hospital discussion, a video, workbook, breastfeeding booklet, and access to a secure website. Additionally, two follow-up phone calls will be made at 1 and 4 weeks postpartum. This intervention has been designed with coparenting elements and contains extensive breastfeeding information.
16181416|NCT01535781|Drug|Tranexamic Acid|1 g of tranexamic acid as a bolus immediately before surgery 3 g of tranexamic acid in 24hours postop.
16181373|NCT01536106|Other|Autologous Bone marrow mononuclear cells|Intracoronary administration of concentrated BMMNC on the same day of BM aspiration using point of care technology.
16181374|NCT01536106|Other|Placebo control|Intracoronary infusion of autologous peripheral blood.
16181375|NCT01536093|Other|oropharyngeal administration of own mother's colostrum|application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.
16181376|NCT01536093|Other|oropharyngeal administration of sterile water|application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.
16181377|NCT01536067|Biological|ofatumumab|Given IV
16181378|NCT01536067|Drug|bortezomib|Given SC
16181379|NCT01536067|Other|laboratory biomarker analysis|Correlative studies
16181380|NCT01536054|Biological|ALVAC(2)-NY-ESO-1 (M)/TRICOM vaccine|Given SC
16181381|NCT01536054|Drug|sirolimus|Given PO
16181382|NCT01536054|Other|laboratory biomarker analysis|Correlative studies
16181383|NCT01536054|Biological|sargramostim|Given SC
16181384|NCT01536041|Drug|ONO-6950|200 mg QD, single dose
16181385|NCT01536041|Drug|ONO-6950|20 mg QD, single dose
16181386|NCT01536041|Drug|Montelukast|10 mg Montelukast, QD single dose
16181387|NCT01536041|Drug|Placebo|Placebo to match ONO-6950 tablets or leukotriene receptor antagonist (LTRA) tablets dosed in a similar manner
16181388|NCT01536028|Drug|biphasic insulin aspart 30|A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
16181389|NCT01536028|Drug|biphasic insulin aspart 50|A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
16181390|NCT01536028|Drug|biphasic insulin aspart 70|A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
16181391|NCT01536028|Drug|insulin aspart|A single dose administrated subcutaneously (s.c., under the skin) on four separate dosing visits in random order with a washout of 1-2 weeks in-between
16181392|NCT01536015|Drug|Rotigotine|"Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours
~Dosage and Frequency: One patch every 24 hours
~Duration: 10 weeks"
16181393|NCT01536015|Drug|Placebo|"Frequency: One patch applied every 24 hours
~Duration: 10 weeks"
16181394|NCT01536002|Drug|Propofol|Intravenous infusion over 30 min of Propofol 3-4 mg/kg body weight
16181395|NCT01535989|Drug|Inotuzumab Ozogamicin|starting dose 0.8 mg/m2, d1 administration, q4wks
16181396|NCT01535989|Drug|Temsirolimus|starting dose of 15mg, weekly administration, q4ws
16181397|NCT01535976|Drug|Placebo|"Placebo Comparator: Placebo
~.9 normal saline infusion"
16181398|NCT01535976|Drug|Ketamine|Ketamine infusion .5mg/kg bolus followed by 1.5 mcg/kg/minute until end of case
16181399|NCT01535950|Drug|LFG316|
16181400|NCT01535950|Drug|Placebo|Placebo will be administered as sham injections. Sham injections will involve placement of the syringe hub against the sclera, without use of a needle.
16181401|NCT01535937|Drug|Ketamine|0.5 mg/kg IV over 40 minutes
16181402|NCT01535937|Drug|Midazolam|0.025 mg/kg IV over 40 minutes
16181403|NCT01535924|Drug|gemcitabine hydrochloride|Given IV
16181404|NCT01535924|Drug|bendamustine hydrochloride|Given IV
16181405|NCT01535911|Other|Energy restricted Ketogenic Diet (ERKD) (Metabolic Nutritional Therapy)|Adult subjects with newly diagnosed glioblastoma will be referred to the study. Residual tumor size will be determined using MRI imaging. Subjects will be placed on ERKD while they are being treated with radiation therapy and standard of care chemotherapy. After completion of radiation therapy, tumor size will be determined using MRI. If the tumor has decreased in size or remained the same (stable disease), the subjects will be continued on the ERKD for an additional 6 weeks. Total calories consumed by each subject will be targeted to 20 to 25 kcal/kg/day. If the tumor has decreased in size or the size has remained the same then subjects will be continued on the ERKD for as additional 6 weeks and a repeat MRI will be obtained.
16181406|NCT01535898|Other|MRI scanner with sequence|The intervention for the patients is the additional 10 minutes in the MRI scanner with sequence. The intervention for the volunteers is the scan, which will take a total of 30 minutes. The volunteers will have two more additional studies at 1-2 week intervals. Both the patients and volunteers will also need to fill out a questionnaire.
16181408|NCT01535872|Dietary Supplement|Dehydroepiandrosterone|DHEA in 25mg capsule. 1 capsule taken 3 times daily for up to 5 months.
16181409|NCT01535859|Drug|Cabergoline|Cabergoline in 0.5mg tablet. 1 tablet daily for 8 days.
16181410|NCT01535859|Drug|Placebo|1 tablet daily for 8 days.
16181411|NCT01535846|Behavioral|Conscious food tasting intervention|Six weekly 2-hour workshops
16181412|NCT01535833|Procedure|Device- Robotic sacral colpopexy|To assess robotic sacral colpopexy for female patients with stage 2 pelvic organ prolapse
16181413|NCT01535820|Drug|Treatment A: ORTHO EVRA patch (NGMN + EE) with an adhesive overlay|NGMN: type= exact number, unit= mg, number= 6, form= transdermal patch, route= transdermal use. EE: type= exact number, unit= mg, number= 0.75, form= transdermal patch, route= transdermal use. A single patch is applied to the buttock with an adhesive overlay applied over the transdermal contraceptive system for 7 days.
16181414|NCT01535820|Drug|Treatment B: ORTHO EVRA patch (NGMN + EE) without an overlay|NGMN: type= exact number, unit= mg, number= 6, form= transdermal patch, route= transdermal use. EE: type= exact number, unit= mg, number= 0.75, form= transdermal patch, route= transdermal use. A single patch is applied to the buttock without an overlay for 7 days.
16181415|NCT01535807|Device|CorMatrix extra cellular matrix (ECM)|"Cormatrix ECM group will receive the CorMatrix ECM during surgery for the closure of the pericardium according to the specific recommended surgical technique.
~No Intervention group will not receive the CorMatrix ECM during surgery, leaving the pericardium open according to current standard of care."
16182252|NCT01529528|Drug|Placebo of Anagliptin|Placebo of Anagliptin 100mg, tablet, BID
16181417|NCT01535781|Drug|Placebo|Identical syringe and drip used as in the intervention, to ensure blinding.
16181418|NCT01535768|Drug|Aqueous Suppressant Eye Drops|"Aqueous suppressant eye drops added stepwise to achieve IOP between 7-10mmHg. First, a beta blocker eye drop (timolol 0.25% 1 gtts in study eye BID OR timolol 0.5% 1 gtts in study eye BID).
~Next, a topical carbonic anhydrase inhibitor eye drop. (brinzolamide 1% 1 gtts in study eye TID OR dorzolamide 2% 1 gtts in study eye TID) Next, a topical alpha agonist eye drop. (brimonidine 0.1% 1 gtts in study eye TID OR brimonidine 0.15% 1 gtts in study eye TID).
~Next, a topical prostaglandin analogue eye drop. (latanoprost 0.005% 1 gtts in study eye qhs OR travoprost 0.004% 1 gtts in study eye qhs OR bimatoprost 0.01% 1 gtts in study eye qhs OR bimatoprost 0.03% 1 gtts in study eye qhs) Finally, stop the topical carbonic anhydrase inhibitor eye drop and start oral acetazolamide. (acetazolamide 250mg PO OD)"
16181419|NCT01535755|Device|protocol|In this group, the patients were weaned as the protocol.
16181420|NCT01535755|Other|physician's orders|In this group, the patients were weaned as the clinicians' order.
16181421|NCT01535742|Device|Ambu Aura-i size 1.5|Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed
16181422|NCT01535742|Device|air-Q ILA size 1.5|Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed
16181423|NCT01535742|Device|Ambu Aura-i size 2|Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed
16181424|NCT01535742|Device|air-Q ILA size 2|Device will be placed and fiberoptic tracheal intubation will be performed and timed. Laryngeal grade of view will also be assessed
16181425|NCT01535716|Behavioral|hemodynamic optimization strategy driven by the ECOM|"goal directed hemodynamic therapy is based on the ECOM evaluation of stroke volume variation (SVV) & cardiac index (CI).
~goals:
~SVV < 11%
~IC > 2,2 ml/min/m²
~During the anesthesia"
16181426|NCT01535716|Behavioral|standard management strategy|"goal directed hemodynamic therapy will be set and performed by the attending anesthetist, based on the analysis of further clinical parameters: Standard monitoring : heart rate, saturation index
~Diuresis > 0,5ml/kg/h
~Blood pressure , PAM > 65 mmHg
~Pulse pressure variation
~CVP 8 to 12 cmH20
~Visual aspect of the heart
~Overload signs During the anesthesia"
16181427|NCT01535690|Other|photodynamic therapy and periodontal debridement|At least two teeth (one with PD ≥ 7 mm and another with PS ≥ 5 mm) were randomly assigned (by coin toss) to one of the treatments: with (test group) or without PDT (control group). After random allocation, all patients received full-mouth ultrasonic debridement using an ultrasonic scaler for 1 hour. Specific tips were used. PDT was performed on only one side of the mouth and the initial step was subgingival irrigation with 0.005% methylene blue dye. To avoid contamination of the control sites with the dye, the methylene blue was applied only inside the periodontal pockets and a high-powered suction device controlled the flow. Two minutes after applying the photosensitizer, the low power laser - AsGaAl was applied for 90 seconds.
16181428|NCT01535677|Drug|Dapagliflozin + Glucophage tablet fasted|Single oral doses of 5 mg dapagliflozin and 850 mg Glucophage® tablets administered together in the fasted state
16181429|NCT01535677|Drug|Dapagliflozin/metformin IR FDC tablet fasted|single oral dose of dapagliflozin/metformin (5 mg/850 mg) IR FDC tablet in the fasted state
16181430|NCT01535677|Drug|Dapagliflozin + Glucophage tablet fed|Single oral doses of 5 mg dapagliflozin and 850 mg Glucophage® tablets administered together in the fed state
16181431|NCT01535677|Drug|Dapagliflozin/metformin IR FDC tablet fed|single oral dose of dapagliflozin/metformin (5 mg/850 mg) IR FDC tablet in the fed state
16181432|NCT01535664|Other|Withdrawal of dalfampridine-ER 10mg|"Withdrawal of dalfampridine-ER 10mg (7 days on study drug followed by withdrawal period of 10 days, followed by on study drug until study completion)
~On drug Day-7 (visit 1) through Day 1 (visit 2)
~Off drug Day 5±2 days (visit 3) through Day 11±2 days (visit 4)
~On drug Day 15±2 days (visit 5)"
16181433|NCT01535651|Behavioral|Teen Outreach Program with Media Enhancement (TOP4ME)|Persons participating in TOP will receive text messages weekly in addition to TOP
16181434|NCT01535638|Drug|BI 207127|Medium dose film-coated tablet
16181435|NCT01535638|Drug|BI 207127|Medium dose film-coated tablet
16181436|NCT01535638|Drug|BI 207127|Medium dose film-coated tablet
16181437|NCT01535625|Device|Momo stent|Patients with PCI
16181438|NCT01535612|Device|PaQ™ insulin infusion device|Basal/bolus insulin therapy administered by CSII for 4 weeks. First two weeks is transition period to identify correct basal rate for the patient, second 2 weeks is treatment period to evaluate efficacy of CSII device.
16181439|NCT01535599|Drug|AL-60371, 0.3% Otic Suspension|
16181440|NCT01535599|Other|AL-60371 Vehicle|Inactive ingredients used as a placebo comparator
16181441|NCT01535586|Device|CPAP versus MAD|Cross over design
16181442|NCT01535573|Drug|Citalopram|20 mg once per day for 9 weeks
16181443|NCT01535573|Drug|Citalopram|40 mg per day for 9 weeks
16181444|NCT01535573|Drug|Placebo|0 mg per day for 9 weeks
16181445|NCT01535560|Drug|AL-60371, 0.3% otic suspension|Investigational otic suspension intended for the treatment of acute otitis externa
16181446|NCT01535560|Drug|AL-60371 Vehicle|Inactive ingredients used as placebo
16181447|NCT01535547|Drug|isavuconazole|oral
16181448|NCT01535547|Drug|tacrolimus|oral
16181449|NCT01535521|Device|Sleep Position Trainer (SPT)|
16181450|NCT01535508|Drug|Liquid Vitamin D|300 IU/Kg/day not to exceed 10,000 IU/day.
16181451|NCT01535495|Drug|Propranolol|Propranolol XL 120mg by mouth once daily
16181452|NCT01535482|Behavioral|Cognitive Therapy|Cognitive therapy (CT) will consist of 12 to 16 individual CT sessions on a weekly basis plus 3 booster sessions.
16181453|NCT01535482|Behavioral|Enhanced Usual Care|Enhanced usual care (EUC) will consist of the usual care that individuals receive for suicide prevention in the community, assessment and referral services provided by study staff, and weekly telephone calls lasting 15-30 minutes provided by study therapists to ensure patient safety and to provide some support.
16181454|NCT01535469|Drug|Fluconazole|Fluconazole 800mg orally daily for 2 weeks, then 400mg daily for 8 weeks
16181455|NCT01535456|Procedure|FLT-PET scans|FLT-PET scans prior to treatment, after Cycle 1, after Cycle 4
16181456|NCT01535443|Drug|Bromfenac|Drug: Bromfenac Other names: PRO-155
16182500|NCT01527864|Drug|Placebo and Paclitaxel-Carboplatin|Dosage：10mg/m2
16181457|NCT01535417|Drug|Shinbaro Capsule|Herbal drug (Ledebouriellae Radix, Achyranthis Radix, Acanthopanacis Cortex, Cibotii Rhizoma, Glycine Semen, Eucommiae Cortex)
16181458|NCT01535417|Drug|Celebrex|
16181459|NCT01535404|Device|Implantation procedure for a St-Jude Medical pacemaker system with right ventricular apex pacing|Implantation procedure for a St-Jude Medical pacemaker system with a transvenous ventricular and if applicable a right atrial lead
16181460|NCT01535404|Device|Implantation procedure for a St-Jude Medical pacemaker system with left ventricular apex pacing|Implantation procedure for a St-Jude Medical pacemaker system with a transvenous left ventricular (coronary sinus) and if applicable a right atrial lead
16181461|NCT01535391|Drug|Nilotinib|Administered orally at the dose of 300 mg twice daily (total daily dose 600 mg daily) for 24 months (study core), and indefinitely if it is in the interest of the patient (the drug will be given free-of-charge after 24 months to all those patients achieving the CMR4 at 24 months and in absence of safety concerns). Nilotinib dose is increased to 400 mg BID in case of suboptimal response or failure (with the exception of patients who will fail for progression to ABP: in case of progression to ABP, the patient will not be treated with study drug and the choise of the treatment will be up to the physician).
16181462|NCT01535365|Other|Heat|Application of heat pack to the back or neck sprain.
16181463|NCT01535365|Other|Cold|Application of ice pack to the back or neck sprain.
16181464|NCT01535352|Behavioral|Mom-Net|"The Mom-Net intervention is an internet-facilitated cognitive-behavioral intervention for depression, adapted from the CWDC, and tailored to mothers of young children. Mom-Net has several core components: 1. A guided course for self-regulated learning of CBT skills. 2. A system of professional support in which coaches provide weekly 15-20 min phone check-ins (coach calls) in order to encourage and facilitate progress through the intervention and respond rapidly to participant queries and emergencies. In this regard, coaches benefited from: a) a 'behind the scenes administration page on the website that enabled them to track participants' progress through the intervention and use this information to tailor coaching sessions; and b) an automated system for alerting coaches/supervisors when participants were in crisis. 3. A coach-moderated bulletin board that approximated the social support provided by group administration."
16181465|NCT01535352|Behavioral|Coach-facilitated Treatment as Usual|Participants in the facilitated usual care (FUC) condition will receive assistance in accessing mental health interventions through community providers that serve low-income individuals. In order to control for the supportive attention provided to mothers in the MN condition by the weekly coach calls, mothers in the FUC condition will receive weekly check-in calls from research staff during the intervention period. Participants in both conditions will receive Booster calls during the follow-up period.
16181466|NCT01535326|Procedure|air insufflation|insufflate air during the insertion of colonoscopy
16181467|NCT01535326|Procedure|water immersion|infuse water during insertion, aspirate water during withdrawal
16181468|NCT01535326|Procedure|water exchange|infuse and remove water during insertion phase of colonoscopy
16181469|NCT01535313|Device|OnControl BM-Biopsy system|Bone marrow biopsy at posterior iliac crest
16181470|NCT01535300|Procedure|Ultrasonography of the trachea|Ultrasonographic measurement of the minimal transverse tracheal diameter
16181471|NCT01535287|Drug|Dexmedetomidine|"Active study agent: Dexmedetomidine at 1 microgram/kilogram Intramuscular (IM) Placebo study agent: Same volume as the study drug of placebo (normal saline).
~All blinding, labeling, preparation, storage of agents done by the pharmacist. The drug will be administered into the deltoid muscle by using a TB syringe attached to a 3/4 inch length and 25 Gauge width needle by anesthesia provider after the induction of general anesthesia by the anesthesia provider."
16181472|NCT01535274|Other|Inspired oxygen fraction / end tidal carbon dioxide|"Following induction of anesthesia, FIO2 and minute ventilation will be sequentially adjusted to achieve:
~FIO2 30% (70% nitrogen), PETCO2 30mmHg - supine position.
~FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position.
~FIO2 100%, PETCO2 30mmHg - beach chair position.
~FIO2 100%, PETCO2 45mmHg - beach chair position.
~FIO2 30% (70% nitrogen), PETCO2 30mmHg - beach chair position."
16181473|NCT01535261|Drug|Ranibizumab 0.5 mg/0.05 ml|Patients will receive the first dose at Baseline, as an intravitreal injection with a standard dose of 0.5 mg/0.05 ml. Patients will receive at least 3 study treatments at monthly intervals (Day 1, Month 1 and Month 2). The last mandatory dose during treatment initiation will be administered approximately 60 days after the first study treatment. If there is no improvement in VA over the course of the first 3 injections, continued treatment is not recommended and the patient may receive alternative treatment at the investigator's discretion.
16181474|NCT01535248|Other|Transthoracic Echocardiography|Patients undergoing ERCP will have surveillance with transthoracic echocardiography with exams occurring every 10 mins or more often if needed to evaluate for the presence of intra-cardiac air associated with ERCP insufflation.
16181475|NCT01535235|Drug|Lisinopril|Lisinopril 20mg QD x 24 weeks
16181476|NCT01535235|Drug|Placebo|Placebo QD x24wks
16181477|NCT01535222|Drug|MDCO-2010|MDCO-2010 solution for infusion. Dosage: Pump priming dose; Loading dose infusion over 6 minutes; Maintenance infusion for duration of surgery
16181478|NCT01535222|Drug|Placebo|Commercially available NaCl
16181479|NCT01535209|Radiation|stereotactic body radiotherapy (SBRT)|18Gy in 1 fraction for resection cavity <2cm in maximum diameter, 15Gy in 1 fraction for resection cavity 2.1-3cm in maximum diameter, 15Gy in 1 fraction or 25 Gy in 5 fractions over 5 days for resection cavity 3.1-4cm in maximum diameter, 25 Gy in 5 fractions over 5 days for resection cavity >4cm in maximum diameter
16181480|NCT01535209|Radiation|Whole-Brain Radiotherapy (WBRT)|10 x 3 Gy to whole brain
16181481|NCT01535196|Drug|Vigantol oil and MCT oil|Vigantol oil, 9 ml, 180 000 IU at the 0,1,2,3,6 month (5 times in the study) MCT oil as placebo, 9 ml, 0,1,2,3,6 month (5 times in the study)
16181482|NCT01535183|Drug|Irinotecan combination chemotherapy|"Irrinotecan 300㎎/㎡ d0 IVS mixed with D5W 500mL over 90min with atropine (-30 min)
~VCR 2㎎/㎡ d0 IV push
~Etoposide 100㎎/㎡ d0-d2 IV over 1hr
~Carboplatin 450㎎/㎡ d0 IV over 8hrs
~Cyclophosphamide 1,000㎎/㎡ d1 IVS with mesna"
16181483|NCT01535170|Dietary Supplement|bovine Lactoferrin|Patients will receive either bLF (10 mg/Kg/day) (Westland Co-operative Dairy Company, New Zealand) or placebo (starch) as control. The dosage of bLF is based on the mean hLF intake that very low body weight neonates ingest with mother's fresh milk in the first 2 weeks of life (30-150 mg/d) [16] and bLF 200 mg bid is found to be effective to suppress Helicobacter pylori [17].
16189281|NCT01477021|Other|laboratory biomarker analysis|Correlative studies
16181484|NCT01535157|Drug|Fenretinide/LXS + Ketoconazole|Starting dose is: Fenretinide/LXS 800 mg 4-HPR/m2/day and Ketoconazole 400 mg/day
16181485|NCT01535144|Device|Fracture compressing screw ZfW 102 Königsee Implantate GmbH|Comparison of two metallic implantable fracture compressing screws
16181486|NCT01535144|Device|Fracture compressing screw titanium Königsee Implantate GmbH|Comparison of two metallic implantable fracture compressing screws
16181487|NCT01535131|Procedure|palatoplasty|procedure to close cleft palate
16181488|NCT01535092|Drug|Silibinin|20mg/Kg daily by intravenous infusion, for 14-21 days pre-OLT and for 7 days post-OLT
16181489|NCT01535092|Drug|Placebo|Saline, daily infused for 14-21 days pre-OLT and for 7 days post-OLT
16181490|NCT01535079|Drug|Placebo|Single administration
16181491|NCT01535079|Drug|Ibuprofen 35 mg|Single administration
16181492|NCT01535079|Drug|Ibuprofen 25 mg|Single administration
16181493|NCT01535079|Drug|Ibuprofen 15 mg|Single administration
16181494|NCT01535079|Drug|Strefen|Single administration
16181495|NCT01535066|Procedure|acupuncture therapy|Receive acupuncture
16181496|NCT01535066|Procedure|sham acupuncture|Receive sham acupuncture
16181501|NCT01535040|Drug|memantine hydrochloride|Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks.
16181502|NCT01535040|Drug|placebo|Placebo by mouth through completion of 12 weeks.
16181503|NCT01535027|Drug|teriparatide|teriparatide 20 ug/day, sc.
16181504|NCT01535027|Drug|teriparatide and raloxifene|teriparatide 20 ug/day sc. raloxifene 60mg oral daily
16181505|NCT01535027|Drug|teriparatide and alendronate|teriparatide 20 ug/day sc. alendronate 70mg oral weekly
16181506|NCT01535014|Drug|Dietressa|Comparison of different dosages (frequency) of drug
16181507|NCT01535014|Drug|Placebo|"Placebo either (2 tablets 3 times daily) or
~(1 tablet 6 times daily)"
16181508|NCT01535001|Other|Neuromuscular training (NEMEX-TJR)|60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
16181509|NCT01535001|Behavioral|Information|"Information on knee osteoarthritis, and on what they can do to treat the disorder and prevent it from being worse.
~Information will be given in a leaflet."
16181510|NCT01535001|Drug|Paracetamol|1 g x 4/day
16181511|NCT01535001|Drug|Burana|400 mg x 3/day for three weeks
16181512|NCT01535001|Drug|Pantoprazole|20mg x 1/day for three weeks
16181513|NCT01535001|Behavioral|Dietary counseling|For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet and plans the number of visits according to the individual participant needs.
16181514|NCT01535001|Behavioral|Patient education|"The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA. This aspect of the intervention is based on principles from The Chronic Disease Self-Management Program, Lær at leve med kronisk sygdom (Learn to live with chronic illness) by The National Board of Health, Denmark and Artrosskolan Spenshult in Sweden."
16181515|NCT01535001|Other|Insoles|"The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).
~The participants will be advised to use the insoles in all shoes."
16181516|NCT01534975|Diagnostic Test|contrast agent|we are randomizing patients to different contrast agents.
16181517|NCT01534962|Drug|Ranolazine|Oral administration, BID; for a maximum of 112 days.
16181518|NCT01534962|Drug|Ranolazine|Oral administration, BID; for a maximum of 112 days.
16181519|NCT01534962|Drug|Ranolazine|Oral administration, BID; for a maximum of 112 days.
16181520|NCT01534962|Drug|Placebo|Oral administration, BID; for a maximum of 112 days.
16181521|NCT01534949|Biological|rituximab|375 mg/m2 by intravenous [IV] infusion
16181522|NCT01534923|Behavioral|surveys|The intervention will be the audio-recording of the physician-patient consultation, patient and doctor surveys. These audio recordings will be coded. It will also include follow-up phone calls with patients.
16181523|NCT01534910|Drug|aged garlic extract|2400 mg a day
16181524|NCT01534910|Drug|placebo|placebo
16181525|NCT01534897|Drug|GSK2118436|150mg twice per day orally for 28 days (42 days if Iodine-131 scan on Day 25 shows new uptake)
16181526|NCT01534884|Biological|rituximab|1000 mg by intravenous (IV) infusion. Each patient may receive 2 courses of treatment.
16181527|NCT01534871|Behavioral|Exercise|Subjects will be enrolled in a 12-week community cardiac rehabilitation program. The program consists of two one hour exercise sessions per week and one one hour education session per week. For the exercise sessions the subjects will perform aerobic exercise at 60-80% of heart rate reserve. Education sessions will cover heart healthy eating, setting health-related goals, exercise, nutrition, healthy weight, medication, smoking cessation and stress/coping.
16181528|NCT01534858|Device|Prontosan Wound Gel X|Prontasan Wound Gel X will be applied topically as a thin layer to the entire grafted area immediately after transplant and with each dressing change.
16181529|NCT01534845|Drug|Temozolomide (Temodal)|RT with daily temozolomide (75 mg/m2/day, 7 days/week) from the first to the last day of radiotherapy) and adjuvant TMZ chemotherapy (150-200 mg/m2 po qd for 5 days q 28 days for 6 cycles)
16181530|NCT01534832|Device|Innervision Surgical Smoke Removal System|Smoke removal by electrostatic precipitation
16181531|NCT01534819|Device|EndoAnchor™|Use of the EndoAnchor™ in conjunction with endograft
16181532|NCT01534819|Procedure|endovascular treament|implantation of a device inserted through an artery
16181533|NCT01534806|Drug|Ketorolac|Ketorolac(0.5mg/kg) IV push
16181534|NCT01534806|Drug|Placebo|Sodium Chloride 0.9% - 10 mL IV push
16181568|NCT01534585|Genetic|Epidermal growth factor receptor status|EGFR expression and mutation before treatment.
16181569|NCT01534572|Dietary Supplement|Lactobacillus|Intervention (2 weeks) with a strain of Lactobacillus
16181535|NCT01534793|Procedure|Holmium Laser Enucleation of the Prostate (HoLEP)|Under regional or general anaesthesia Urethroscopy to check the location of the prostatic capsule Enucleation of the prostatic lobes (median if present, then lateral lobes)Hemostasis Morcellation Device : LUMENIS Laser
16181536|NCT01534780|Procedure|laparoscopic ventral herniotomy|Laparoscopy in general anesthesia are performed with placement of Physiomesh intraperitoneally. Fixation of the mesh is performed with 1 of 3 possible devices
16181537|NCT01534780|Device|Protack|fixation of mesh with protack
16181538|NCT01534780|Device|Securestrap|fixation of mesh with Securestrap
16181539|NCT01534780|Device|Glubran|fixation of mesh with Glubran
16181540|NCT01534754|Drug|Mesalazine plus Lactobacillus casei|Active Mesalazine 800 mg, 2 tablets/day and active Lactobacillus casei, 1 sachet/day for 10 days/month for one year.
16181541|NCT01534754|Drug|Mesalazine placebo plus Lactobacillus casei placebo|Mesalazine 800 mg placebo, 2 tablets/day and Lactobacillus casei placebo, 1 sachet/day for 10 days/month for oe year.
16181542|NCT01534754|Drug|Mesalazine 800 mg|Active mesalazine 800 mg, 2 tablets/day and Lactobacillus casei placebo, 1 sachet/day for 10 days/month for one year.
16181543|NCT01534754|Drug|Lactobacillus casei|Mesalazine 800 mg placebo, 2 tablets/day and active Lactobacillus casei, 1 sachet/day for 10 days/month for one year.
16181544|NCT01534741|Other|dialyzer comparison|Each patient will be treated by post-dilution online hemodiafiltration once with each dialyzer type (FX CorDiax 60or FX 60 ) The order of dialyzers used will be randomly assigned to the patient at the time of randomisation by lot. Every subject will be treated one time with each dialyzer. In order to achieve controlled conditions, the mid- or end-week session data will be used, only.
16181545|NCT01534741|Device|Dialyzer|Comparison Dialyzer FX60 versus Cordiax60
16181546|NCT01534715|Drug|IMGN529|
16181547|NCT01534702|Drug|clofarabine, cytarabine, idarubicin|"Treatment is stratified according to patients age (< 60 years vs. ≥ 60 years).
~Medication:
~Patients < 60 years:
~idarubicin 7.5 mg/m2 iv, days 1 + 3
~cytarabine 750 mg/m2 iv, days 1 to 5
~Patients ≥ 60 years:
~idarubicine 6 mg/m2 iv, days 1 + 3
~cytarabine 750 mg/m2 iv, days 1 to 5
~Clofarabine will be given in escalating doses to cohorts of at least three patients:
~Clofarabine:
~level -1: 15 mg/m2 iv, days 1 to 5
~level 1: 20 mg/m2 iv, days 1 to 5
~level 2: 25 mg/m2 iv, days 1 to 5
~level 3: 30 mg/m2 iv, days 1 to 5
~level 4: 35 mg/m2 iv, days 1 to 5
~Patients will be recruited according to a 3+3 design. New cohorts will be initiated depending on toxicity of the previous cohort during the first induction cycle. Enrollment will begin with dose level 1."
16181548|NCT01534689|Device|Erchonia FX-405™ Laser|The Erchonia FX-405™ dual diode laser light is directed at the great toenail at a distance of approximately 6 inches above the toenail. The dual wavelengths of 405 nm and 635 nm are activated simultaneously for 10 minutes of total treatment administration time.
16181549|NCT01534676|Procedure|Transfusion|A routine medical procedure to transfuse packed red blood cells.
16181550|NCT01534676|Biological|Blood|"Processing of RBC for transfusion include the following:
~Fresh
~Stored
~Washed
~Frozen (Cryopreserved)"
16181551|NCT01534676|Procedure|Chelation therapy|(non-experimental) A medical procedure that involves the administration of chelating agents to remove heavy metals from the body.
16181552|NCT01534663|Drug|Glutamine and Fish Oil Supplementation|This is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days.
16181553|NCT01534663|Drug|Placebo|This is a prospective, randomized double-blind, placebo-controlled study design. 38 subjects will be randomized to two groups (19 patients in each group), one taking active fish oil and glutamine supplementation and the other taking placebo for 90 days.
16181554|NCT01534637|Drug|aprepitant|Given PO
16181555|NCT01534637|Drug|gemcitabine hydrochloride|Given IV
16181556|NCT01534637|Drug|capecitabine|Given PO
16181557|NCT01534637|Drug|fluorouracil|Given IV
16181558|NCT01534637|Procedure|radiation therapy|Undergo radiation therapy
16181559|NCT01534637|Other|questionnaire administration|Ancillary studies
16181560|NCT01534637|Procedure|quality-of-life assessment|Ancillary studies
16181561|NCT01534637|Procedure|nausea and vomiting therapy|Receive aprepitant
16181562|NCT01534637|Procedure|management of therapy complications|Receive aprepitant
16181563|NCT01534598|Drug|FdCyd + THU|Intravenous FdCyd with THU has been evaluated in a Phase I clinical trial with some preliminary evidence of activity. This trial will investigate oral administration of the drugs, which was shown be feasible in an expansion cohort of the previous trial.
16181564|NCT01534585|Drug|Icotinib|"Oral Icotinib begins on day 1 and continues until completion of radiotherapy. Phase I:The initial plan is to accrue 6 patients to each dose level (125mg, qd and bid and tid) in each cohort. If one or none of six patients have dose limiting toxicity (DLT), then escalation will proceed. If DLT occurs in two or more patients at a dose level, then escalation will be stopped. The dose level below that at which two of six patients experience a DLT is defined as the maximum-tolerated dose. A minimum of 4 weeks of observation is required after completion of radiation within each Icotinib dose level before accrual to the next level.
~Phase II:According to the maximum tolerated dose, 50 patients will been recruited."
16181565|NCT01534585|Radiation|intensity-modulated radiotherapy|The nasopharyngeal regions and upper neck with IMRT plans will be generated and approved for each patient, whereas the low-neck and supraclavicular regions will be used with a conventional anterior field. A total of 70-76Gy at 2.12-2.3Gy/fraction/d will be given to the GTVnx, the GTVnd will receive 66-70Gy at 2.0-2.12Gy/fraction/d, the CTV1 will receive 60-66Gy at 1.8-2.0Gy/fraction/d, and the CTV2 received 56-60Gy at 1.7-1.8Gy/fraction/d with IMRT. The low-neck and supraclavicular regions will receive 50-60Gy at 2.0Gy/fraction/d with conventional radiotherapy. Target prescription dose and critical structures limit dose are planned according to the RTOG0225 trial.
16181566|NCT01534585|Drug|Paclitaxel and Cisplatin|AC that consisted of two cycles of paclitaxel 135 mg/m2 on day 1 plus cisplatin 30 mg/m2 on days 1-3 will start 4 weeks after the end of CRT.
16181567|NCT01534585|Other|Quality of life|The EORTC QLQ-C30 and H&N35 of the Chinese version, which is obtained from the Quality of Life Unit, EORTC Data Center in Brussels, Belgium, is available and easily completed by our patients are chosen for this study. Patients will complete the questionnaire before treatment and after treatment and one month after treatment and three months after treatment and one year after treatment.
16181570|NCT01534572|Dietary Supplement|Bifidobacterium|Intervention (2 weeks) with a strain of Bifidobacterium
16181571|NCT01534559|Other|Medicines Management Outpatient service|New customised clinical pharmacy service (medicines management clinic and follow-up phone calls)
16181572|NCT01534546|Drug|Oxaliplatin capecitabine|capecitabine：1000 mg/m2 ，bid, d1~14 oxaliplatin：130mg/m2，iv drip for 2h，d1
16181573|NCT01534546|Drug|Oxaliplatin S-1|S-1: 40~60mg bid，po, d1~14 （S-1：BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid） oxaliplatin：130mg/m2，iv drip for 2h，d1
16181574|NCT01534546|Drug|Oxaliplatin S-1|S-1: 40~60mg bid，d1~14 （S-1：BSA <1.25m2, 40mg bid, 1.25m2≤BSA≤1.5m2,50mg bid, BSA>1.5m2, 60mg bid） oxaliplatin：130mg/m2，iv drip for 2h，d1 S-1 monotherapy as the same dose and schedule of the above
16181575|NCT01534533|Dietary Supplement|Placebo|one gelatine capsule containing starch per day, for 12 months
16181576|NCT01534533|Dietary Supplement|Lutein group|one gelatine capsule containing 20mg lutein per day, for 12 months
16181577|NCT01534533|Dietary Supplement|Combination group|one gelatine capsule containing 20mg lutein and 20 mg lycopene per day, for 12 months
16181578|NCT01534533|Dietary Supplement|Normal lutein control group|subjects without early atherosclerosis, treated with one gelatine capsule containing 20mg lutein per day, for 12 months
16181579|NCT01534520|Drug|Lidocaine|Intravaginal insertion of 4mL 2% lidocaine gel
16181580|NCT01534520|Drug|Placebo|KY Jelly
16181581|NCT01534494|Drug|Psilocybin|two doses of 0.3 mg/kg PO and 0.4 mg/kg PO, separated by 4 weeks in combination with 12 weeks of manualized outpatient psychosocial treatment including preparation, debriefing, and motivational enhancement therapy.
16181584|NCT01534468|Biological|Monovalent Influenza Subvirion Vaccine, H7N7|At study entry, all participants will receive one IM injection of approximately 45 micrograms of inactivated Monovalent Influenza Subvirion Vaccine, H7N7.
16181585|NCT01534455|Drug|Lapatinib + 1,23 mg Eribulin|Lapatinib 1000 mg/day + Eribulin 1,23 mg/m2 i.v. on day 1 and 8, q21
16181586|NCT01534455|Drug|Lapatinib + 1,76 mg Eribulin|Lapatinib 1000 mg/day + Eribulin 1,23 mg/m2 i.v. on day 1 and 8, q21
16181587|NCT01534442|Drug|Atropine|1 mg as a bolus and the and infusion of 80 ng/kg/min for either 105 or 145 minuts.
16181588|NCT01534442|Drug|Placebo|
16181589|NCT01534429|Procedure|Quantitative Sensory Testing|Quantitative Sensory Testing and Neurophysiologic Testing to be done Pre-operatively and at 3 and 6 months post-operatively.
16181590|NCT01534416|Drug|Bupivacaine|Subjects are injected paracervically with 10 ml of 0.5% bupivacaine with 1:200000 units epinephrine prior to surgical incision.
16181591|NCT01534416|Drug|Normal Saline|Subjects are injected paracervically with 10 ml of normal saline prior to surgical incision.
16181592|NCT01534403|Biological|Epratuzumab|Epratuzumab 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over eight 12-week treatment cycles (ie, Weeks 0, 1, 2, 3, 12, 13, 14, 15, 24, 25, 26, 27, 36, 37, 38, 39, 48, 49, 50, 51, 60, 61, 62, 63, 72, 73, 74, 75, 84, 85, 86, and 87)
16181593|NCT01534390|Device|In-line microfilter (Supor IV Filter; Pall Corporation, Port Washington, New York)|use of in-line microfilters with a pore size of 0,2 mcm and 1,2 mcm (only if parenteral nutrition is administered) at all intravenous accesses
16181594|NCT01534377|Behavioral|Interpersonal Psychotherapy for Adolescents|Adolescents will receive IPT-A a manualized intervention for depression and prevention of depression that emphasizes current interpersonal relationships, focusing on their immediate social context.
16181595|NCT01534377|Behavioral|Enhanced Care|Adolescents will receive enhanced care which is consistent with care typically provided in community settings to treat and prevent depression.
16181596|NCT01534364|Other|calorie restriction|Calorie Restriction to 60% of the calculated daily energy rate from day -7 until day -1 (included) pre-surgery (day 0 corresponds to day of surgery)
16181597|NCT01534351|Drug|Finasteride|Finasteride 5 mg oral tablet taken once daily.
16181598|NCT01534351|Drug|Tamsulosin|Tamsulosin 0.2 mg oral capsule taken once daily.
16181599|NCT01534351|Drug|Finasteride-matching placebo|Matching placebo to finasteride 5 mg oral tablet taken once daily.
16181600|NCT01534351|Drug|Tamsulosin-matching placebo|Matching placebo to tamsulosin 0.2 mg oral capsule taken once daily.
16181601|NCT01534338|Behavioral|Mindfulness Meditation|Participants will attend weekly 2-hour classes for a total of 6 weeks and participants will monitor their sleep with a daily sleep diary.
16181602|NCT01534338|Behavioral|Sleep Education|Participants will attend weekly 2-hour classes for a total of 6 weeks and participants will monitor their sleep with a daily sleep diary.
16181603|NCT01534325|Device|SD|"The participants in the study receive basic nutrition guidance by MD and clinical dietician and make daily use of the device under study (called SD). During the 13 weeks study period, the participants get to meet clinical dietician/MD once in every 2 weeks for guidance and supervision and for on -going monitoring of physical parameters such as body weight and waist circumference.
~The use of the SD device is done by study participants during the day every day throughout the study period. The device under study can be easily used by the participants themselves in their regular environment and does not require professional assistance.
~The device under study is expected to affects the satiety, energy homeostasis and metabolic control centers in the brain and by that to reduce food intake and lead to weight loss.
~The device under study is a device- not a medication and not a surgical procedure, and it does not involve any of such elements."
16181604|NCT01534325|Device|Control|"The participants in the Control arm of the study receive basic nutrition guidance by MD and clinical dietician and make daily use of the placebo. During the 13 weeks study period, the participants get to meet clinical dietician/MD once in every 2 weeks for guidance and supervision and for on -going monitoring of physical parameters such as body weight and waist circumference.
~The use of the placebo is done by the control study participants during the day every day throughout the study period. The placebo can be easily used by the participants themselves in their regular environment and does not require professional assistance."
16181650|NCT01534026|Other|withdrawal of aspirin|Stopping current dose of aspirin
16181730|NCT01533389|Drug|Silodosin|"Drug: silodosin dosage form : capsule dosage : placebo 4mg*2 (8mg) frequency and duration : QD, 4weeks
~Arms: Placebo"
16181605|NCT01534325|Device|SD|"The participants in the study receive basic nutrition guidance by MD and clinical dietician and make daily use of the device under study (called SD). During the 13 weeks study period, the participants get to meet clinical dietician/MD once in every 2 weeks for guidance and supervision and for on -going monitoring of physical parameters such as body weight and waist circumference.
~The use of the SD device is done by study participants during the day every day throughout the study period. The device under study can be easily used by the participants themselves in their regular environment and does not require professional assistance.
~The device under study is expected to affects the satiety, energy homeostasis and metabolic control centers in the brain and by that to reduce food intake and lead to weight loss.
~The device under study is a device- not a medication and not a surgical procedure, and it does not involve any of such elements."
16181606|NCT01534312|Drug|CGMP protein|Casein glycomacropeptide purified powder dissolved in 300 ML water once daily
16181607|NCT01534312|Drug|Maximal oral 5ASA|4800 grams/day of Mesalazine (Asacol/Mezavant)
16181609|NCT01534286|Drug|Theramine|Theramine 2 capsules 3 times per day
16181610|NCT01534286|Drug|Theramine- like placebo|Theramine-like placebo capsules 2 three times daily
16181611|NCT01534273|Drug|LY2886721|Administered orally.
16181612|NCT01534273|Drug|Placebo|Administered orally.
16181613|NCT01534260|Drug|sorafenib, vorinostat and bortezomib|Escalating dose cohorts of sorafenib, vorinostat and bortezomib. The first cohort will receive sorafenib from day 1 to 14, vorinostat will be given on days 1-4 and 8-12, and bortezomib will be given on days 1 and 8. This will be followed by 7 days of rest. Therefore each cycle will be 21 days.
16181614|NCT01534247|Drug|CAZ-AVI|Infusion
16181615|NCT01534247|Drug|metronidazole|Infusion
16181616|NCT01534247|Drug|CAZ-AVI + metronidazole|Infusion
16181617|NCT01534234|Device|PARADYM RF SONR|SonR CRT Optimization
16181618|NCT01534234|Device|PARADYM RF SONR|Echocardiography Optimization
16181619|NCT01534221|Device|Biomatrix drug eluting stent|Biomatrix drug eluting stent
16181620|NCT01534208|Drug|Androxal|Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated
16181621|NCT01534195|Drug|Prednisolone Sodium Phosphate Ophthalmic Solution 1%|One drop in each eye, four times/day for 8 days.
16181622|NCT01534195|Drug|Tears Naturale II Ophthalmic Solution|one drop in each eye, four times/ day (QID) for 8 days
16181623|NCT01534182|Drug|Fingolimod|0.5 mg orally once a day
16181624|NCT01534182|Drug|Interferon beta - 1a (IFN)|44 mcg subcutaneously three times a week
16181625|NCT01534182|Drug|Glatiramer acetate (GA)|20 mg subcutaneously once a day
16181626|NCT01534169|Drug|Dexamethasone|The course of treatment will be last for 3 months. The intrathyroid injection of dexamethasone will be performed using a 25-gauge (0.25-mm) needle under ultrasound guidance. The injection will be performed in both lobes of the thyroid. The dosage of dexamethasone is 5mg (1.0 ml) in each lobe, twice a week during the first month of the treatment. The treatment strategy will be changed to once a week in the second month and twice a month in the third month; the dosage of dexamethasone is the same as in the first month.
16181627|NCT01534143|Other|pharmacological study|Correlative studies
16181628|NCT01534143|Drug|tacrolimus|Given IV
16181629|NCT01534143|Drug|sirolimus|Given PO
16181630|NCT01534143|Biological|anti-thymocyte globulin|Given IV
16181631|NCT01534143|Drug|fludarabine phosphate|Given IV
16181632|NCT01534143|Drug|busulfan|Given IV
16181633|NCT01534143|Drug|bortezomib|Given IV
16181634|NCT01534143|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo allogeneic HSCT
16181635|NCT01534143|Other|laboratory biomarker analysis|Correlative studies
16181636|NCT01534130|Device|Acupuncture|Participants will receive five sessions of verum acupuncture in the first week after randomization, three sessions in the second and third weeks after randomization, and two sessions in the forth week after randomization.
16181637|NCT01534130|Device|Sham acupuncture|Participants will receive five sessions of sham acupuncture in the first week after randomization, three sessions in the second and third weeks after randomization, and two sessions in the forth week after randomization.
16181638|NCT01534117|Biological|Platelets|1 unit of platelets
16181639|NCT01534117|Drug|DDAVP|Desmopressin 0.3mcg/kg IV x 1
16181640|NCT01534104|Procedure|preoperative fMRI. DTI and DSI with tractography|W/I approx 4-6 weeks of the fMRI, DTI & DSI, neurological/physical testing & brain MRI showing tumor &/or edema located in or near (<2 cm) the motor cortex (precentral gyrus), motor pathway (corticospinal tract), language cortex (Broca's area, Wernicke's area), &/or language pathway (arcuate fasciculus) Preoperative MRI for surgical planning (approximately <48 hours before surgery*) fMRI to localize gray matter DTI, DSI & tractography to localize white matter, DSI & updated fMRI (Optional) Most patients will undergo surgery w/i 48 hrs of their preoperative MRI. For some patients, the MRI results will be used for preoperative counseling. In this subset of patients, we expect that surgery will occur w/i 3-4 months of the MRI. Brain tumor resection as per the treating neurosurgeon Electrical stimulation to localize gray &/or white matter structures if clinically necessary according to the standard of care at MSKCC Postoperative neurological/physical examination (<48 hours after surgery)
16181641|NCT01534091|Behavioral|Pedometer with supervision|
16181642|NCT01534091|Behavioral|Pedometer without supervision|
16181643|NCT01534078|Drug|Brentuximab Vedotin|2 doses administered 14 days apart; followed by combination therapy with AVD for 4-6 cycles; 1.2 mg/kg
16181644|NCT01534078|Drug|Adriamycin, vinblastine, and dacarbazine|Combination therapy with brentuximab for 4-6 cycles; 25 mg/m2 Adriamycin; 6 mg/m2 Vinblastine; 375 mg/m2 Dacarbazine
16181645|NCT01534065|Device|Barricaid|Implanted intra-operatively during discectomy
16181646|NCT01534052|Drug|Enzalutamide|Oral
16181647|NCT01534039|Device|Sur-Fit Natura|ConvaTec Moldable Skin Barrier for ostomy patients
16181648|NCT01534039|Device|FormaFlex|Hollister skin barrier for ostomy patients
16181649|NCT01534026|Drug|Aspirin|Current dose
16181651|NCT01534013|Device|The Imperial College Closed-Loop Insulin Delivery System|The Imperial College closed-loop insulin delivery system comprises 3 main components: the glucose sensor, the control algorithm and the insulin delivery system.
16181652|NCT01534013|Device|Open loop|glucose sensor and pump
16181653|NCT01534000|Procedure|Cardiac computed tomographic angiography (CCTA)|Patients will (on top of the standard clinical evaluation with a functional-based stress-test) be examined with a Cardiac CT scan. In the control group, the Cardiac CT will be blinded for clinical evaluation and only used retrospectively for research purpose.
16181654|NCT01533987|Dietary Supplement|Juice Plus|Juice Plus is the combination of Juice Plus+® Garden Blend, Juice Plus+® Orchard Blend and Juice Plus+® Vineyard Blend.
16181655|NCT01533974|Other|Acceptance & Commitment Therapy (ACT)|We will use a five-session (90 minutes per session) group-delivered adaptation of Dr. Bricker's ACT treatment program.
16181656|NCT01533974|Other|Cognitive Behavioral Therapy (CBT)|The control condition will be the current group-delivered CBT smoking cessation program at GH.
16181657|NCT01533961|Drug|SCYX-7158|
16181658|NCT01533961|Drug|Placebo|
16181659|NCT01533948|Drug|axitinib|Given PO
16181660|NCT01533948|Other|laboratory biomarker analysis|Correlative studies
16181661|NCT01533935|Drug|Placebo|placebo matching tiotropium + olodaterol
16181662|NCT01533935|Drug|Tiotropium + Olodaterol|Tiotropium 2.5 mcg + olodaterol 5 mcg once daily
16181663|NCT01533935|Drug|tiotropium + Olodaterol|tiotropium 5 mcg + olodaterol 5 mcg once daily
16181664|NCT01533935|Drug|Tiotropium|tiotropium
16181665|NCT01533935|Drug|Olodaterol|Olodaterol 5 mcg once daily
16181666|NCT01533935|Device|Respimat|Respimat inhaler
16181667|NCT01533922|Drug|Placebo|placebo matching tiotropium + olodaterol FDC
16181668|NCT01533922|Drug|Tiotropium|Tiotropium 5 mcg once daily
16181669|NCT01533922|Drug|Olodaterol|Olodaterol 5 mcg once daily
16181670|NCT01533922|Drug|tiotropium + olodaterol|tiotropium + olodaterol 5 mcg once daily
16181671|NCT01533922|Drug|Tiotropium + Olodaterol|Tiotropium 2.5 mcg + Olodaterol 5 mcg once daily
16181672|NCT01533922|Device|Respimat|Respimat inhaler
16181673|NCT01533896|Behavioral|Grow Nicely|Grow Nicely is a multimedia educational tool, developed at Vanderbilt University that teaches why and how to help children reach and maintain a healthy weight.
16181674|NCT01533870|Drug|NKTR-118|Oral 25 mg
16181675|NCT01533870|Drug|Rifampin|Oral 600 mg
16181676|NCT01533857|Dietary Supplement|hot water|Hot water and placebo capsule
16181677|NCT01533857|Dietary Supplement|Black tea and phenolic acids|Black tea extract and capsule with phenolic acids
16181678|NCT01533818|Drug|Amoxicillin|"80-100 mg/kg/day in 2 divided doses for 7 days
~For convenience dose divided into six weight bands Table 2: Dose of amoxicillin Weight band Amount per dose Daily dose Lower Limit (mg or units /kg/d) Upper Limit (mg or units /kg/d) Amoxicillin - desired range 75-100 mg/kg/day (25mg/ml (125mg/5ml); twice daily orally)* 1.8-1.9 kg 3.0 ml 150 mg 75.4 100.0 2.0-2.4 kg 4.0 ml 200 mg 80.3 100.0 2.5-2.9 kg 5.0 ml 250 mg 83.6 100.0 3.0-3.9 kg 6.0 ml 300 mg 75.2 100.0 4.0-4.9 kg 8.0 ml 400 mg 80.2 100.0 5.0-5.9 kg 10.0 ml 500 mg 83.5 100.0"
16181679|NCT01533818|Drug|Sugar Syrup|It will be given 2 times/day for 7 days
16181680|NCT01533805|Other|Pilates exercises with stabilization|This group will focus on exercises with core stabilizing muscles. The frequency will be 16 sessions lasting 1 hour.
16181681|NCT01533805|Other|Classic Pilates|This group will make Pilates exercises its focus is on mobilization exercises of the lumbar spine. The frequency will be 16 sessions lasting 1 hour.
16181682|NCT01533792|Procedure|Supra/subgingival scaling using periodontal curette scraping|The experimental group received supra and subgingival therapy with periodontal curettes
16181683|NCT01533792|Procedure|Supra and subgingival scaling|The experimental group received supra and subgingival scaling.
16181684|NCT01533766|Drug|CombiflexOmega|intravenously over 5 days infusion
16181685|NCT01533766|Drug|SmofKabiven|intravenously over 5 days infusion
16181686|NCT01533753|Drug|Gabapentin|Gabapentin will be administered orally at a starting dose of 300mg at bedtime (titration encouraged to desired effect and tolerability per treating physician). Maximum dose allowed will be 300mg three times a day. One cycle is defined as 28 +/- 7 days.
16181687|NCT01533753|Drug|Venlafaxine|Venlafaxine will be administered orally at the starting dose of 37.5mg daily (titration allowed to desired effect and tolerability per treating physician). Maximum dose allowed will be 75mg per day. One cycle is defined as 28 +/- 7 days.
16181688|NCT01533740|Drug|fluorouracil/irinotecan/levo-folinic acid/bevacizumab|standard first line chemotherapy with: bevacizumab 5 mg/kg intravenous (i.v.) infusion on day 1; irinotecan 180 mg/m2 i.v. infusion on day 1, levo-folinic acid 200 mg/m2 i.v. infusion on day 1, 5-fluorouracil 400 mg/m2 i.v. bolus on day 1 and 2,400 mg/m2 i.v. infusion over 46 hours; infusions repeated every 2 weeks
16181689|NCT01533727|Drug|Autologous CIK Transfusion plus Chemotherapy|vinorelbine 25-30mg/m2 d1, d8 q3w; DDP 75mg/m2 d1 q3w; pemetrexed 500mg/m2 d1 q3w; carboplatin AUC 5/6 q3w; CIK infusion D14 q3w
16181690|NCT01533727|Drug|chemotherapy alone|vinorelbine 25-30mg/m2 d1, d8 q3w; DDP 75mg/m2 d1 q3w; pemetrexed 500mg/m2 d1 q3w; carboplatin AUC 5/6 q3w;
16181691|NCT01533714|Biological|Olokizumab|"Solution for injection with a concentration of Olokizumab of 100 mg/mL Subjects will receive CDP6038 at a dose of 120 mg every two weeks.
~This study will continue until approval of the marketing application for the indication of RA in the subject's country or region or until further notice from UCB."
16181692|NCT01533701|Other|Fetal scalp blood scalp, amniotic fluid, maternal blood and umbilical cord sampling|Fetal blood sampling is conducted when a non reassuring cardiotocographic pattern occurs to detect fetal hypoxia during labor. Amniotic fluid, maternal blood is sampled in cases of fetal blood sampling. Umbilical cord blood sampling is conducted at delivery.
16181693|NCT01533688|Drug|Golytely (polyethylene glycol electrolyte lavage solution) and placebo|4 liters of polyethylene glycol electrolyte lavage solution (PEG-ELS-(GoLytely))+ placebo given the evening prior to the colonoscopy
16181694|NCT01533688|Drug|split dose of Golytely (polyethylene glycol electrolyte lavage solution) + placebo|split dose (2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters Golytely + placebo
16181729|NCT01533402|Behavioral|Internet-delivered CBT|Internet-delivered cognitive behavioural therapy with therapist support
16181695|NCT01533688|Drug|split dose of Golytely (polyethylene glycol electrolyte lavage solution) and bisacodyl|split dose ( 2 L taken the evening before and 2 L taken the morning of the colonoscopy) of 4 liters of Golytely + bisacodyl 10 mg
16181696|NCT01533675|Other|Hydrogen peroxide|Once daily topical application of 3% hydrogen peroxide using a cotton-tipped applicator
16181697|NCT01533675|Other|Saline|Once daily topical application of normal saline, using a cotton-tipped applicator
16181698|NCT01533662|Drug|phenylephrine infusion|patients from 60 to 75 years receiving 100micrograms of phenylephrine infusion
16181699|NCT01533662|Drug|patients receiving saline infusion|patients more than 60 years receiving 100micrograms of saline infusion
16181700|NCT01533649|Behavioral|Andrews/Reiter approach to epilepsy|"The Andrews/Reiter approach to epilepsy is a systematic semi-directive, multi-modal counseling intervention that integrates conventional therapies, educational modules, psychological interventions and relaxation techniques in order to assist the individual in improving self-defined life quality. Face-to-face counseling sessions and supervision with telephone calls are based on a standardized workbook (Taking Control of Your Epilepsy) as an on-going step-by-step guideline."
16181701|NCT01533649|Behavioral|Relaxation/Meditation|Subjects who participate in the relaxation control group will attend weekly relaxation sessions that will employ the following relaxation techniques: meditation, progressive muscle relaxation, autogenic training.
16181702|NCT01533623|Device|Mandibular Advancement Device|Nightly wearing time
16181703|NCT01533610|Procedure|Stellate ganglion block|Local anesthesia applied to the stellate ganglion in the neck
16181704|NCT01533597|Drug|Solifenacin|Solifenacin (5mg, qd, oral)
16181705|NCT01533597|Drug|Solifenacin plus Tamsulosin|Solifenacin (5mg, qd, oral) plus Tamsulosin (0.2mg, qd, oral)
16181706|NCT01533571|Procedure|Immediate implant placement with simultaneous bone grafting|"Flapless surgery is used for surgical implant installation.
~Implant is placed in the cingulum position of adjacent teeth incisal edge.
~After placement of optimal implant the remaining gap between the implant and the surrounding bony walls should be at least 2 mm or should be need for GBR of buccal plate outside the socket.
~Two types of bone graft materials will be applied for two groups of patients: Group I - natural bovine bone grafting material + resorbable natural soft tissue membrane; Group II - processed human allograft + resorbable natural soft tissue membrane .
~Crown can be fixed on abutment if there is initial stability under 35 Ncm insertion torque. If insertion torque will be less, crown should be bond to neighboring teeth using composite material."
16181707|NCT01533558|Drug|caspofungin|normal dosage for caspofungin, not adapted for the study
16181708|NCT01533545|Drug|Mepivacaine with epinephrine|Ultrasound-guided infraclavicular brachial plexus block with mepivacaine 400 mg (10 mg/mL) mixed with epinephrine 200 μg (5 μg/mL)
16181709|NCT01533545|Drug|Plain mepivacaine|Ultrasound-guided infraclavicular brachial plexus block with plain mepivacaine 400 mg (10 mg/mL)
16181710|NCT01533532|Drug|KLH-2109|
16181711|NCT01533532|Drug|KLH-2109|
16181712|NCT01533532|Drug|KLH-2109|
16181713|NCT01533532|Drug|placebo|
16181714|NCT01533519|Drug|Neuropeptide Y|Intranasal administration will be administered with a nasal drug delivery device.
16181715|NCT01533506|Drug|stiripentol|Stiripentol up to 30 mg/kg/day to control seizures
16181716|NCT01533493|Drug|Placebo|Memantine-matched placebo will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.
16181717|NCT01533493|Drug|Memantine Hydrochloride|Memantine will be prescribed following approved FDA dosing guidelines for Alzheimer's dementia, beginning at 5mg in AM and increasing in BID doses by 5mg weekly to a maximum dose of 10mg BID.
16181718|NCT01533493|Drug|OROS-Methylphenidate|OROS-Methylphenidate will be openly prescribed, starting with an initial dose of 36mg/day and titrated to optimal response to a maximum daily dose of 1.3mg/kg or 108mg/day, whichever is lower, according to clinician judgment. During titration, dose will be increased on a weekly basis in 36mg/day increments. The dose may be reduced by 18 or 36mg/day increments if adverse effects occur or if the subject discontinues treatment.
16181719|NCT01533480|Drug|Zirgan|0.15% ganciclovir gel(Zirgan)
16181720|NCT01533480|Drug|genteal gel|0.3% Hypromellose gel
16181721|NCT01533467|Device|Perineal protection device|Use of the device during delivery and inspection afterwards to see the tears.
16181722|NCT01533454|Other|Financial Incentives|Incentive arm participants will be able to earn incentives for meeting specified weight loss targets or step goals. They will be offered a choice between traditional (payments with certainty) and behavioral(payments paid via lottery) incentives.
16181723|NCT01533441|Dietary Supplement|Vitamin K2|4 months retrospective period and 4 months dairy product + treatment (vitaminK2 or placebo) intervention
16181724|NCT01533428|Drug|Capsaicin 8%|Capsaicin 8% transdermal delivery system
16181725|NCT01533428|Drug|Placebo|Placebo Patch
16181726|NCT01533415|Device|CES treatment using Alpha-Stim technology|Treatment involves the passage of micro current levels of electrical stimulation across the head via electrodes placed bilaterally on the ears. The current used in this device is no stronger than the current that naturally occurs in the human body. Treatment is delivered using a current equal to 0.5 Hz for a period of 60 mins. Treatment will be self-administered on a daily basis 5-7 days per week.The manufacturer of the device, Electro medical Products, Inc. will provide the devices for the study. They will alter the functional devices to deliver treatment at a therapeutic level of <1 mA. The current cannot be altered by the participant. Participants will be required to log the date, time, and duration of treatment. The logs will be provided by the PI and will be collected weekly. Participants will also be required to complete the Hamilton Anxiety Rating Scale (HAM-A) and the Hamilton Depression Rating Scale 17 (HAM-D17) at baseline and at weeks 1, 3, and 5.
16181727|NCT01533415|Device|Shame CES Treatment|Treatment will be self-administered on a daily basis 5-7 days per week.The manufacturer of the device, Electro medical Products, Inc. will provide the devices for the study. They will alter the devices so they cannot emit an electrical current. The ability for the device to emit a current cannot be altered by the participant. Participants will be required to log the date, time, and duration of treatment. The logs will be provided by the PI and will be collected weekly. Participants will also be required to complete the Hamilton Anxiety Rating Scale (HAM-A) and the Hamilton Depression Rating Scale 17 (HAM-D17) at baseline and at weeks 1, 3, and 5.
16181728|NCT01533402|Behavioral|therapist support|Weekly therapist support without CBT-interventions
16181731|NCT01533389|Drug|Placebo|dosage form : capsule dosage : placebo 4mg*2 (8mg) frequency and duration : QD, 4weeks
16181732|NCT01533376|Drug|Timolol|0.5% timolol maleate ophthalmic gel-forming solution applied once
16181733|NCT01533376|Drug|Preservative free artificial tear gel.|Preservative free artificial tear gel applied topically twice a day.
16181734|NCT01533363|Procedure|Stapled hemorrhoidopexy|
16181735|NCT01533363|Procedure|Milligan Morgan|
16181736|NCT01533337|Procedure|Free dorsal digital flap|The dorsal digital flap, including both dorsal branches of the proper digital nerves, was designed on the dorsum of the donor finger between the distal third of the proximal phalanx and the distal interphalangeal joint.
16181737|NCT01533324|Drug|S-1 combined with Leucovorin|S-1 capsules 80mg/m2/d BID one week on and one week off Leucovorin tablets 50mg/d BID one week on and one week off
16181738|NCT01533298|Drug|CombiflexOmega peri|intravenously over 3 days infusion
16181739|NCT01533298|Drug|SmofKabiven peripheral|intravenously over 3 days infusion
16181740|NCT01533285|Biological|Placebo|Placebo is Treatment A and C. Form=saline solution for intramuscular (IM) injection (Injection of a solution into a muscle), route = IM, Unit = mL, number = 0.5 administered on Day 1 of Period 1 and Period 2.
16181741|NCT01533285|Biological|Salmonella typhi vaccine (Typhim Vi)|Salmonella typhi vaccine (typhoid vaccination) in Treatment B and D; Unit = mg, number = 0.025, form = solution for intramuscularly (IM) injection, route = IM administered on Day 1 of Period 1 and Period 2.
16181742|NCT01533272|Drug|Tenofovir, emtricitabine, maraviroc|experimental drug
16181743|NCT01533272|Drug|Tenofovir, emtricitabine, lopinavir/r|Lopinavir/r 400mg BID
16181744|NCT01533259|Drug|Stribild|Elvitegravir (EVG) 150 mg/cobicistat (COBI) 150 mg/emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen (STR) administered orally once daily with food
16181745|NCT01533246|Drug|linsitinib|Oral Linsitinib 150mg, twice a day, days 1- 28
16181746|NCT01533246|Other|laboratory biomarker analysis|Correlative studies
16181747|NCT01533233|Procedure|thoracoscopic lobectomy and mediastinal lymph node dissection|
16181748|NCT01533220|Drug|naphazoline hydrocloride|02 drops into each nostril, 04 times a day for 03 days
16181749|NCT01533220|Drug|Naphazoline hydrocloride + Pheniramine Maleate + Panthenol|02 drops into each nostril each 12 hours for 03 days
16181750|NCT01533207|Other|Clinical Observation|Patients followed clinically
16181751|NCT01533207|Drug|Docetaxel|Given IV
16181752|NCT01533207|Drug|Doxorubicin Hydrochloride|Given IV
16181753|NCT01533207|Biological|Filgrastim|Given subcutaneously (SC)
16181754|NCT01533207|Drug|Gemcitabine Hydrochloride|Given IV
16181755|NCT01533207|Biological|Pegfilgrastim|Given SC
16181756|NCT01533194|Other|Diagnostic Laboratory Biomarker Analysis|Correlative studies
16181757|NCT01533194|Biological|Wild-type Reovirus|Given IV
16181758|NCT01533181|Other|Laboratory Biomarker Analysis|Correlative studies
16181759|NCT01533181|Drug|Linsitinib|150 mg given orally (PO) twice a day (BID)
16181760|NCT01533181|Other|Pharmacological Study|Correlative studies
16181761|NCT01533181|Drug|Topotecan Hydrochloride|1.5 mg/m^2 intravenously (IV) or 2.3 mg/m^2 orally (PO)
16181762|NCT01533168|Genetic|cytogenetic analysis|
16181763|NCT01533168|Genetic|nucleic acid sequencing|
16181764|NCT01533168|Other|diagnostic laboratory biomarker analysis|
16181765|NCT01533168|Other|laboratory biomarker analysis|
16181766|NCT01533168|Other|medical chart review|
16181767|NCT01533155|Drug|Nektar 118|Oral 25 mg tablet
16181768|NCT01533155|Drug|Quinidine|Oral 200 mg tablet
16181769|NCT01533155|Drug|Quinidine placebo|Oral Tablet
16181770|NCT01533155|Drug|Morphine|10 mg/ml, intravenously
16181771|NCT01533142|Procedure|Bariatric surgery|"Patients will be treated with one of two bariatric procedure::
~sleeve gastrectomy or gastric bypass"
16181772|NCT01533142|Procedure|Bariatric surgery|Surgical methods vary between hospitals: Voss: sleeve gastrectomy, Haugesund: gastric bypass (Roux-en Y),SUS: gastric bypass (Roux-en Y); Førde: biliopancreatic diversion with duodenal switch (BPD / DS) and sleeve gastrectomy
16181773|NCT01533129|Drug|Testogel 50 mg transdermal gel|50mg testosterone gel implementation on every night
16181774|NCT01533129|Drug|Testosterone 250mg injection|The testosterone 250mg ester IM injections performed in three weeks.
16181775|NCT01533116|Drug|BIA 9-1067|
16181776|NCT01533116|Drug|Placebo|
16181777|NCT01533116|Drug|levodopa/carbidopa|
16181778|NCT01533116|Drug|levodopa/benserazide|
16181779|NCT01533090|Drug|polyethylene glycol (PEG)|SELG-ESSE 1000 4 L: 2L THE DAY BEFORE OF COLONOSCOPY AND 2 L THE SAME DAY OF COLONOSCOPY
16181780|NCT01533090|Drug|PEG low volume with bisacodyl|Lovolesse + Lovoldyl 2L of Lovolesse with 2 or 3 tablets of bisacodyl the day before of colonoscopy or 2L of Lovolesse with 2 or 3 tablets of bisacodyl the same day of colonoscopy
16181781|NCT01533077|Drug|BIA 9-1067|50 mg of BIA 9-1067 (single-dose)
16181782|NCT01533077|Drug|Sinemet® 100/25 mg|immediate-release levodopa/carbidopa 100/25 (single-dose).
16181783|NCT01533038|Device|UroLift System|The NeoTract UroLift System is a medical device approved for sale in the European Union, Australia, New Zealand, Canada, Serbia, and Turkey. It was developed for the intended use of soft tissue approximation and for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra.
16181784|NCT01533038|Procedure|Transurethral Resection of the Prostate|Transurethral Resection of the Prostate (TURP) is a surgical procedure which removes prostatic tissue by electrocautery dissection. During the procedure the tissue at the bladder neck and the adjacent adenoma are resected in quadrants. Resection continues into the midportion of the gland and concludes at the apex. Any remaining residual tissue is cleared, leaving a void from verumontanum to bladder neck.
16181785|NCT01533025|Procedure|anterior cruciate ligament reconstruction|single bundle anterior cruciate ligament reconstruction with Achilles allograft
16181786|NCT01533012|Procedure|Pressure difference|Peak inspiratory pressures difference between two lungs
16181787|NCT01532999|Behavioral|Mindfulness Based Stress Reduction|MBSR is a manualized program involving 8 weekly classes and a single 6-hour silent retreat session based on a systematic procedure to develop enhanced non-reactive awareness of the moment-to-moment experience of perceptible mental processes.
16181788|NCT01532999|Behavioral|Present Centered Group Therapy|The comparison control group will be PCGT, which was initially developed for use as a control group in a VA multi-site study that tested the effects of Trauma-Focused Group Therapy. Correspondingly, PCGT serves as a credible control for the nonspecific effects of a group-based intervention (i.e. controls for time, attention, expectation of recovery, and recognition of the illness).
16181789|NCT01532986|Other|Coordinated care management for Parkinson's disease|Nurse care managers will use standardized assessment tools and care coordination protocols to address unmet needs of Veterans with PD, and collaborate with these Veterans and their families, providers, and community partners to manage PD care.
16181790|NCT01532986|Other|Educational handout|"To minimize potential bias from participants' awareness of randomization arm assignment, the investigators will provide to all study participants (intervention arm and usual care arm) on enrollment a brief educational handout on Parkinson's disease that is available in the VA's Healthwise for Life handbook (page 273). This information includes a definition of PD, its symptoms, and several suggestions for managing PD such as medications and regular exercise."
16181791|NCT01532973|Drug|Elbasvir|Elbasvir was administered orally by tablet(s)
16181792|NCT01532973|Drug|Placebo|Dose-matched placebo tablets were administered orally.
16181793|NCT01532960|Biological|poly-ICLC|poly-ICLC
16181794|NCT01532960|Biological|9 Peptides from Her-2/neu, CEA, & CTA|9 synthetic peptides derived from Her-2/neu, CEA & CTA derived breast cancer proteins.
16181795|NCT01532960|Biological|Peptide-tet|A class II MHC-restricted helper peptide derived from tetanus toxoid protein.
16181796|NCT01532947|Procedure|post placement|placement of an endocanalar post
16181797|NCT01532934|Behavioral|motivational enhancement therapy|Four 45-minute MET sessions
16181798|NCT01532934|Other|standard care|
16181799|NCT01532921|Procedure|Tricuspid valve repair|
16181800|NCT01532921|Procedure|Left-sided heart surgery|Tricuspid valve repair was with the study device was only warranted if concomitant left-sided heart surgery was planned
16181801|NCT01532921|Device|Contour 3D Tricuspid Annuloplasty Ring|Contour 3D Tricuspid Annuloplasty procedure was used during the tricuspid valve repair
16181802|NCT01532908|Biological|MBL-HCV1|50 mg/kg MBL-HCV1, intravenous, up to 15 infusions over 56 days; option for extended treatment through 84 days if viral load undetectable at day 56
16181803|NCT01532908|Drug|Telaprevir (Part 1)|Two 375 mg tablets, 3 times a day up to 56 days; option for extended treatment through 84 days if viral load undetectable at day 56
16181804|NCT01532908|Drug|Sofosbuvir (Part 2)|One 400 mg tablet, 1 time per day up to 56 days; option for extended treatment through 84 days if viral load undetectable at day 56
16181805|NCT01532895|Drug|Hydromorphone HCI OROS|type= exact number, unit= mg, number=4, form= tablet, route= oral use. One tablet administered once a day. The dose may be increased if the level of pain increases or if the pain-killing effect is insufficient.
16181806|NCT01532882|Drug|Diosmin|tablet, 600mg, PO, 1 tab per day during 28 days
16181807|NCT01532882|Drug|Placebo|tablet, PO, 1 per day during 28 days
16181808|NCT01532869|Drug|Placebo|Subcutaneously weekly, Weeks 0-48
16181809|NCT01532869|Drug|tocilizumab [RoActemra/Actemra]|162 mg subcutaneously weekly, Weeks 0-48
16181810|NCT01532869|Drug|tocilizumab [RoActemra/Actemra]|162 mg subcutaneously weekly, Week 48-96
16181811|NCT01532856|Drug|Thalidomide, Cyclophosphamide, Dexamethasone|Thalidomide - 200mg per day, orally, during 9 cycles of 28 days each cycle Cyclophosphamide - 50mg per day, orally, during 9 cycles of 28 days each cycle Dexamethasone - 40mg orally(two pulses the first two cycles in days 1-4 and 15-18 and then a single pulse in each other cycle) during 9 cycles of 28 days.
16181812|NCT01532856|Drug|Thalidomide, Dexamethasone|Thalidomide - 200mg per day, orally, during 9 cycles of 28 days each cycle Dexamethasone - 40mg orally, in three pulses (days 1 to 4, 9 to 12 and 17 20) odd cycles and a single pulse treatment in pairs cycles, during 9 cycles of 28 days each cycle
16181813|NCT01532856|Drug|Thalidomide, Melphalan, Prednisone|thalidomide - 200mg per day, orally, during 9 cycles of 28 days each cycle; melphalan - 4 mg/m2, days 1-7, orally, during 9 cycles of 28 days each cycle; prednisone - 40 mg/m2, days 1-7, orally, during 9 cycles of 28 days each cycle
16181814|NCT01532843|Drug|PegIFN alfa-2b|Peginterferon alpha-2b 1.5 μg/kg per week s.c.for 48 weeks
16181815|NCT01532830|Device|n-VNS|
16181816|NCT01532817|Device|AlphaCore|A single 90 second stimulation to the vagus nerve on the right side of the neck
16181817|NCT01532804|Drug|bevacizumab, oxaliplatin and 5FU combination|"Bevacizumab 5 mg/kg administered as an iv infusion for 1h30, then for 1h and for 30 min. at the following cycles, respectively.
~Oxaliplatin 85 mg/m² administered as an iv infusion for 2h Elvorine 200 mg/m² administered as an iv infusion for 2h 5FU 400 mg/m2 bolus then 5FU 2,400 mg/m² iv infusion for 46h D1=D15 (12 cycles)"
16181818|NCT01532804|Drug|Bevacizumab, oxaliplatin and raltitrexed combination|"Bevacizumab 7.5 mg/kg administered as an iv infusion for 1h30, then administered for 1h and 30 min at the following cycles, respectively.
~Oxaliplatin 130 mg/m² administered as an iv infusion for 2h Raltitrexed 3 mg/m² administered as an iv infusion for 15 min"
16181819|NCT01532765|Procedure|Pars plana vitrectomy and epiretinal membrane peel|23 gauge pars plana vitrectomy with diluted intravitreal triamcinolone for visualization
16181820|NCT01532765|Procedure|ILM peel assisted by ICG|Indocyanine green dye is prepared from 25mg powder vial from AKORN INC., 10 mL diluent provided in kit. This is further diluted to final concentration of 0.5mg/mL using 50% sterile dextrose solution
16181821|NCT01532765|Procedure|CE-IOL|Cataract extraction by phacoemulsification and insertion foldable posterior chamber intraocular lens implant
16181854|NCT01532466|Drug|Rocuronium|All patients were given oxygen via a face mask. The patients were then administered with the following medications intravenously: the rocuronium group received rocuronium 0.06 mg kg-1, and the control group received the same volume of normal saline 30 s before the injection of an IV fentanyl bolus (1.5 mcg kg-1, within 2 s).
16181855|NCT01532453|Device|MD-3511356|Every morning MD-3511356 should be applied liberally to those skin areas exposed to direct sunlight before exposing to the sun.
16182533|NCT01527500|Drug|LFG316|LFG316 5 mg/50 μL solution for IVT injection,
16181822|NCT01532739|Behavioral|Cognitive training|The cognitive training consists of 10 weekly 2-hour sessions. It is run with groups of MCI participants and their study partners (who help with reinforcing the strategies in everyday activities). The program provides information about memory and lifestyle factors in the first two weeks, followed by training and practice over the next eight weeks on empirically-supported cognitive strategies known to be effective at supporting day-to-day remembering in MCI. Participants learn to apply a core set of strategies (spaced retrieval, memory book logging) across a variety of common memory problems (e.g., remembering names, appointments, etc). To enhance the likelihood that these strategies will transfer to other settings beyond training, participants are also taught a memory problem solving approach that will cue them to recognize situations in which they need to: (1) stop and remember something, (2) select and apply an appropriate memory strategy, and (3) monitor that it is working.
16181823|NCT01532726|Drug|ESL|ESL 400/800/1200 mg tablets once daily
16181824|NCT01532713|Procedure|oxygen administration|nasal O2 5L/min via nasal cannula
16181825|NCT01532700|Drug|Ofatumumab with GSK2110183|"GSK2110183 125mg OD continuously
~Ofatumumab 300mg IV first dose, 2000mg weekly x 7 doses, then 2000mg monthly x 4 doses"
16181826|NCT01532687|Drug|Gemcitabine|Given IV
16181827|NCT01532687|Drug|Gemcitabine Hydrochloride|Given IV
16181828|NCT01532687|Other|Laboratory Biomarker Analysis|Correlative studies
16181829|NCT01532687|Drug|Pazopanib|Given PO
16181830|NCT01532687|Drug|Pazopanib Hydrochloride|Given PO
16181831|NCT01532687|Other|Placebo Administration|Given PO
16181832|NCT01532674|Device|Antimicrobial photodynamic therapy (Periowave) and scaling and root planing|"ROOT PLANNING PROCEDURE:
~The procedure is the same as in the control group
~APPLICATION PROCEDURES OF THE PHOTOSENSITIZING AGENT :
~The photosensitive agent : Formulation Periowave Treatment Kit-2ml
~Application of the photosensitive using a blunt needle at the bottom of the periodontal pocket with circular movements covering the entire perimeter of the tooth.
~Application of diode laser with a peak of 8.5 cm. long with a curvature of 60 degrees and flexible. Making a move in and out from the apical region to the more coronal region of the periodontal pocket. Each tooth has a working time of 60 seconds.
~All the periodontal pockets will be treated subgingivally
~Elimination of the photosensitive by irrigation"
16181833|NCT01532674|Procedure|scaling and root planing|"ROOT PLANNING PROCEDURE:
~An unique operator ( independent from the explorer) will do the root planing for both the test and control group.
~Every procedure will be done under local anaesthesia: Ultracain with Epinephrine 40/0,01 mg/ml. NORMON. It will be done a first session of root planning in the first and forth quadrant and in a 48 hours the root planning of the second and the third quadrant will be done. Every session wil be done with this material: Ultrasonic: Satelec suprasson p5 with ultrasonic tip H3, manual scalers: HU-FRIEDY 1/2, 7/8, 11/12, 13/14, 13/14 columbia.
~* The session will finish as soon as the operator have removed all the supragingival and subgingival calculus and plaque."
16181834|NCT01532661|Other|observational study|data collected by investigators
16181835|NCT01532648|Drug|Budesonide MMX®|Oral tablet taken daily in the morning after breakfast.
16181836|NCT01532648|Drug|Placebo|Matching budesonide MMX placebo oral tablet taken daily in the morning after breakfast.
16181837|NCT01532648|Drug|5-ASA|"Acceptable oral 5-ASA medications to be received during the study include:
~Asacol®, Asacol® HD, Lialda®, Pentasa® (generic: mesalamine), minimum daily dose ≥2.4 grams (g)
~Azulfidine® (generic: sulfasalazine), minimum daily dose ≥4.0 g
~Dipentum® (generic: olsalazine), minimum daily dose ≥2.0 g
~Colazal®, Colazide® (generic: balsalazide), minimum daily dose ≥6.75 g"
16181838|NCT01532635|Radiation|Total Body Irradiation (TBI)|TBI twice daily for 4 days and occurs 6 to 9 days prior to the transplant. Total radiation dose is 12 Gy.
16181839|NCT01532635|Biological|Donor Lymphocyte Infusion (DLI)|DLI given 6 days prior to transplant (HSCT).
16181840|NCT01532635|Drug|Cyclophosphamide (CY)|Cyclophosphamide given once daily at 60 mg/kg on days 2 and 3 prior to transplant (HSCT).
16181841|NCT01532635|Drug|Tacrolimus|Tacrolimus is started the day before the transplant and stops a few months after transplant.
16181842|NCT01532635|Drug|Mycophenolate Mofetil (MMF)|MMF is started the day before transplant and stops a few weeks after transplant.
16181843|NCT01532635|Biological|Hematopoietic Stem Cell Transplant (HSCT)|"CD34+ selected Hematopoietic Stem Cell Transplant (HSCT) is performed using donor cells from two related donors.
~The CliniMACS® Plus Instrument will be used for the selection of human CD34+ hematopoietic stem cells."
16181844|NCT01532622|Dietary Supplement|Blueberry Powder|Patients will take 30 grams of blueberry powder daily for up to 30 days
16181845|NCT01532622|Other|Placebo Powder|Patients will take 30 grams of placebo powder daily for up to 30 days.
16181846|NCT01532609|Behavioral|MMT CARE|Intervention group service providers received four training sessions (plus reunion sessions) on MMT protocol, reducing stigma and its impact, maintaining positive interactions with clients, and motivational interviewing skills. The participating providers are required to conduct three individual motivational sessions with their clients upon completion of the intervention sessions.
16181847|NCT01532596|Behavioral|Mindfulness-Based Stress Reduction|8-week standardized mindfulness meditation training program
16181848|NCT01532583|Other|Gynaecological examination, a supine stress test, questionnaires|Gynaecological examination, a supine stress test, questionnaires
16181849|NCT01532570|Drug|TA-650|TA-650 will be intravenously infused at a dosage of 5 mg/kg slowly over a period of more than 2 hours at the first administration (weeks 0), 2, and 6, and then every 8 weeks up to week 46. If the criteria for a dosage escalation are met at the evaluation after week 30, TA-650 will be administered at a dosage of 10 mg/kg after week 30.
16181850|NCT01532544|Drug|Ilomedin and Integrilin|Continuous infusion
16181851|NCT01532544|Drug|low molecular weight heparin.|
16181852|NCT01532531|Device|"GEMORE Multi-Function Electrotherapy Stimulator"|"The Collateral Meridian Therapy (CMT) group patients received, according to the CMT protocol described previously (5), CMT at the selected points with the CMT Electrotherapy Stimulator (GEMORE Multi-Function Electrotherapy Stimulator; GM390TE, GEMORE Co Ltd, Taiwan) to treat the affected OA knee. The 6-minute treatment (electrotherapy was set at 40 Hz biphasic and 30 mA) comprises reduction and enhancement procedures on the specific points. Each patient received CMT twice per week for three weeks during the study."
16181853|NCT01532518|Drug|Nepadutant|Nepadutant oral solution
16182009|NCT01531218|Drug|azithromycin|azithromycin, oral use, 500mg per day for 3 days in total. Total dose 1500mg
16181856|NCT01532453|Other|Standard Sun Protection Measures|Self-provided commercially available sunscreen products, corresponding to the dosage recommendations on the product.
16181857|NCT01532414|Drug|Androxal|oral, capsules, taken one time daily, for 3 months
16181858|NCT01532414|Drug|Placebo|Oral capsule taken one time daily for 3 months
16181859|NCT01532401|Other|sodium chloride|sodium chloride 500mg
16181860|NCT01532401|Other|Methylcellulose crystalline|Methylcellulose 37 ml
16181861|NCT01532388|Behavioral|eScreen|Web based self-monitoring of problematic alcohol and drug use.
16181862|NCT01532375|Dietary Supplement|Kochujang|Kochujang (32g/day) for 12weeks.
16181863|NCT01532375|Dietary Supplement|placebo|placebo(32g/day) for 12weeks
16181864|NCT01532362|Drug|Apricoxib|As part of the trial, forty eligible subjects will be randomly assigned to receive Apricoxib 400 mg orally once daily or no drug intervention for a 7 day period (Days 0-6) prior to surgical resection of the lung tumor but between the two surgeries.
16181865|NCT01532349|Drug|Cholecalciferol|Children will be randomly allocated to receive either cholecalciferol supplementation 4000 IU per day 400 IU/day. We are proposing a supplementation dose of 4000 IU/day in children with CKD, which is considered a safe dose by KDOQI standards; vitamin D2 doses as high as 10,000 IU/day have been given to French patients with CKD for > 1 year with no evidence of vitamin D toxicity. Cholecalciferol will be provided in both tablet and liquid form, based on the ability to tolerate and preference of the subject. Participants will be monitored for signs of 25D toxicity (hypercalcemia, hyperphosphatemia, hypercalciuria) during the follow up period of 1 month and 3 months from baseline.
16181866|NCT01532336|Drug|NVC-422 Solution, 0.3%|NVC-422 Ophthalmic Solution dropped onto the eye
16181867|NCT01532336|Drug|NVC-422 Vehicle Solution|NVC-422 Vehicle Ophthalmic Solution dropped onto the eye
16181868|NCT01532323|Other|Taking of saliva before and after gustatory stimulation|Taking of saliva before and after gustatory stimulation (3 drops of citric acid 2.4 g / L)
16181869|NCT01532310|Drug|belimumab|Belimumab is a recombinant, human, IgG1λ monoclonal antibody for the treatment of systemic lupus erythematosus
16181870|NCT01532297|Device|Citrate dialysate (CiDi)|Use during chronic dialysis 3x/week
16181871|NCT01532297|Device|Standard dialysate (StDi)|Use during chronic dialysis 3x/week
16181872|NCT01532284|Other|Polar Body Biopsy|PB biopsy (PBB) will be performed between 9 and 12 hours after ICSI using laser or the mechanical procedure. PB1 and PB2 will be removed simultaneously (both at the same time) and transferred to different tubes for the chromosomal analysis.
16181873|NCT01532258|Behavioral|Go! Foods for You without Weekly MA Support.|"Participants access and utilize an 8-week online program which provides educational materials and weekly activities based on a Mediterranean diet and dietary practices that have been associated with healthy weights.
~Each day participants receive educational materials related to the nutritional science of a Mediterranean diet. Each week (1) a new theme for the daily educational materials is presented and (2) participants are asked to schedule activities on a built in calendar and practice the activity throughout the week."
16181874|NCT01532258|Behavioral|Go! Foods for You with Weekly MA Support.|"Participants access and utilize an 8-week online program which provides educational materials and weekly activities based on a Mediterranean diet and dietary practices that have been associated with healthy weights.
~In addition to the 8-week online program, participants receive weekly support by Medical Assistants (MA) over the phone or by email to establish a relationship and maintain program adherence by discussing the previous week's behavioral goals and setting weekly behavioral goals."
16181875|NCT01532245|Other|two lung ventilation (TLV)|During two-lung ventilation (TLV) and OLV 8 ml•kg-1 tidal volume was used.
16181876|NCT01532245|Other|one lung ventilation (OLV) without PEEP|During OLV, ventilation periods of ten minutes, with and without 5 cmH2O positive end-expiratory pressure (PEEP) were alternated.
16181877|NCT01532245|Other|One lung ventilation (OLV) with positive end-expiratory pressure (PEEP)|During OLV, ventilation periods of ten minutes, with and without 5 cmH2O positive end-expiratory pressure (PEEP) were alternated
16181878|NCT01532232|Drug|placebo|Pts will receive the standard 12-week dosing regimen consisting of 1 mg po of study drug twice daily for 11 weeks,along with smoking cessation counseling, for 11 weeks with an initial dose titration to full strength during the 1st week as follows: 0.5 mg po once daily for 3 days titrated to 0.5mg po twice daily for 4 days. 154 pills will be supplied for the 12 week tx. In order to compensate for any accidentally dropped or lost pills during the study duration, a total of 175 pills will be given to the patient. Along with smoking cessation counseling, for 11 weeks. Pts will receive their medication from the MSK Pharmacy & equivalent dosing & side effect education from our Tobacco Cessation Nurse Practitioner. Tx with the study drug will begin after the initial counseling session. Physicians & tobacco cessation nurses will be blinded regarding pts' assignment to medication or placebo tx arm. Likewise, pts will not be informed as to which medication condition they have been assigned.
16181879|NCT01532232|Drug|varenicline|Pts will receive the standard 12-week dosing regimen consisting of 1 mg po of study drug twice daily for 11 weeks,along with smoking cessation counseling, for 11 weeks with an initial dose titration to full strength during the 1st week as follows: 0.5 mg po once daily for 3 days titrated to 0.5mg po twice daily for 4 days. 154 pills will be supplied for the 12 week tx. In order to compensate for any accidentally dropped or lost pills during the study duration, a total of 175 pills will be given to the patient. Along with smoking cessation counseling, for 11 weeks. Pts will receive their medication from the MSK Pharmacy & equivalent dosing & side effect education from our Tobacco Cessation Nurse Practitioner. Tx with the study drug will begin after the initial counseling session. Physicians & tobacco cessation nurses will be blinded regarding pts' assignment to medication or placebo tx arm. Likewise, pts will not be informed as to which medication condition they have been assigned.
16181880|NCT01532219|Behavioral|Internet-delivered Psychodynamic Treatment|Ten weeks of guided self-help + therapist contact, via the Internet.
16181881|NCT01532219|Behavioral|Internet-delivered structured support|Ten weeks of therapist contact, via the Internet.
16181882|NCT01532206|Other|Blood pressure cuff insufflation|Blood pressure cuff will be inflated to a pressure of 200mmHg for 5 minutes. This will be repeated x 3, separated by 5 minutes.
16181883|NCT01532193|Other|Decreased oxygen concentration|"The oxygen concentration is decreased during the in Vitro embryo culture."
16182010|NCT01531218|Drug|Placebo|
16182501|NCT01527838|Biological|Single FT1050 treated UCB unit|Ex-vivo CXCR4 upregulated hematopoietic progenitor cells, cord blood
16181884|NCT01532180|Device|aura6000 System|The aura6000 device is an implanted hypoglossal nerve stimulator designed to maintain wakeful muscle tone of the tongue during sleep. It is implanted through a short surgical procedure. The implant is programmed to provide the optimal stimulation parameters for the patient. The therapy is controlled by a hand-held remote control allowing the patient to start, stop, and pause the therapy during times of sleep.
16181885|NCT01532154|Drug|Fampridine|As prescribed and taken after the last menstrual period prior to becoming pregnant or anytime during the pregnancy
16181886|NCT01532141|Drug|BIA 9-1067|50 mg BIA 9-1067 (single-dose)
16181887|NCT01532141|Drug|Rasagiline|1 mg rasagiline (single-dose)
16181888|NCT01532128|Drug|rasagiline|1 mg rasagiline (single-dose)
16181889|NCT01532128|Drug|BIA 9-1067|50 mg BIA 9-1067 (single-dose)
16181890|NCT01532115|Drug|BIA 9-1067|50 mg and 800 mg of BIA 9-1067 (single-dose)
16181891|NCT01532115|Drug|Placebo|single-dose
16181892|NCT01532115|Drug|moxifloxacin|400 mg moxifloxacin (single-dose)
16181893|NCT01532102|Drug|AP611074|
16181894|NCT01532102|Drug|Placebo|Placebo gel manufactured to appear identical to AP611074 5% gel
16181895|NCT01532089|Biological|Bevacizumab|Given IV
16181896|NCT01532089|Drug|Erlotinib|Given PO
16181897|NCT01532089|Drug|Erlotinib Hydrochloride|Given PO
16181898|NCT01532089|Other|Laboratory Biomarker Analysis|Correlative studies
16181899|NCT01532076|Procedure|Cellularized composite graft augmentation|liposuction, cell isolation, embedding of SVF cells in fibrin gel, wrapping around hydroxyapatite granules
16181900|NCT01532076|Procedure|Acellular composite graft augmentation|Open reduction and internal fixation using acellular augmentation with fibrin embedded granulated hydroxyapatite
16181901|NCT01532063|Procedure|INTUBATION IN INTENSIVE CARE UNIT|Standard intubation procedure used in Intensive Care Unit
16181902|NCT01532050|Device|Mandibular Advancement Device ( MAD)|
16181903|NCT01532037|Other|Cognitive behavioural therapy based self help|Comparison of cognitive behavioural therapy based pure self help and guided self help (support of a therapist) compared to treatment as usual
16181904|NCT01532037|Other|Treatment as usual|Usual care from healthcare professionals with regard to patients symptoms of fatigue
16181905|NCT01532024|Other|Microdose of NAP|Delivery of NAP at microdose (<100mcg) by direct pulmonary administration followed by fibreoptic confocal microendoscopy
16181906|NCT01532011|Drug|Erlotinib|"Dose escalation group starting dose: 75 mg by mouth daily for a 28 day cycle.
~Dose expansion group starting dose: Maximum tolerated dose (MTD) from dose escalation group."
16181907|NCT01532011|Drug|Pralatrexate|"Dose escalation group starting dose: 15 mg/m2 by vein on days 1, 8, and 15 of a 28 day cycle.
~Dose expansion group starting dose: Maximum tolerated dose (MTD) from dose escalation group."
16181908|NCT01531998|Drug|Lenalidomide|Induction Phase: 25 mg by mouth daily on Days 1-14. Maintenance Phase: at last tolerated dose from Induction Phase day 1-21 every 28 days for up to 12 months and then may be reduced to 10 mg.
16181909|NCT01531998|Drug|Bortezomib|"Induction Phase: 1.3 mg/m2 by vein daily on Days 1, 4, 8 and 11.
~Maintenance Phase: 1.3 mg/m2 by vein or last tolerated dose on Day 1 and Day 8."
16181910|NCT01531998|Drug|Siltuximab|"Induction Phase Starting Dose: 11 mg/kg by vein on Day 1.
~Maintenance Phase: 11 mg/kg intravenous every 21 days, or maximum tolerated dose from induction therapy."
16181911|NCT01531998|Drug|Dexamethasone|"Induction Phase: 20 mg by mouth on Days 1, 2, 4, 5, 8, 9, 11, 12.
~Maintenance Phase: 20 mg by mouth on Days 1, 2, 4, 5, 8, 9, 11, 12. If participant still on Dexamethasone, when entering Maintenance Phase, dose reduced to 20 mg a week."
16181912|NCT01531998|Behavioral|Questionnaires|M. D. Anderson Symptom Inventory Module (MDASI-MM) completed Day 1, Day 8 of Cycle 1 - 8, and on Day 1 of Cycle 9 and beyond.
16181913|NCT01531972|Drug|SEP-228432|40 mg, orally, once daily for 3 days followed by 200 mg orally, once daily for 5 days
16181914|NCT01531972|Drug|SEP-228432|40 mg orally once daily for 3 days followed by ≤ 300mg, orally once daily for 5 days
16181915|NCT01531959|Drug|Midodrine|Patients will be randomized to blinded to 20 mg of midodrine
16181916|NCT01531959|Drug|Placebo|Patients will be randomized to blinded placebo control
16181917|NCT01531946|Procedure|MRI Scan|"Patients will have to spend additional 10min in the scanner.
~Additional scan modalities used:
~Perfusion without contrast: Arterial spin labeling (ASL) with the ability of showing signs of ischemia.
~Diffusion tensor imaging (DTI): Has a higher sensitivity than DWI in displaying local ischemic lesions.
~An overall 20min scan period."
16181918|NCT01531933|Drug|DLBS3233|For the first 4 weeks, subjects should take DLBS3233 at the dose of 50 mg once daily. For the next (or last) 8 weeks, all subjects who do not respond well (poor responders) to the study regimen will receive a titrated dose of 100 mg once daily, while the (good) responders will remain at the previous dose regimen. Good responders are defined as those who achieve 2h-PG level of < 140 mg/dL or a decrease of 2h-PG level of ≥ 10% from baseline; otherwise will be called poor responders. At every study visit, subjects will be provided with an education on lifestyle modification given by the assigned nutritionist.
16181919|NCT01531933|Drug|Placebo of DLBS3233|For the first 4 weeks, subjects should take placebo of DLBS3233 at the dose of 50 mg once daily. For the next (or last) 8 weeks, all subjects who do not respond well (poor responders) to the study regimen will receive a titrated dose of 100 mg once daily, while the (good) responders will remain at the previous dose regimen. Good responders are defined as those who achieve 2h-PG level of < 140 mg/dL or a decrease of 2h-PG level of ≥ 10% from baseline; otherwise will be called poor responders. At every study visit, subjects will be provided with an education on lifestyle modification given by the assigned nutritionist.
16181920|NCT01531920|Drug|alcohol + placebo|Part A alcohol + placebo
16181921|NCT01531920|Drug|alcohol + perampanel|Part A: alcohol + perampanel
16181922|NCT01531920|Drug|perampanel + alcohol|Part B: perampanel + alcohol
16181923|NCT01531920|Drug|placebo + alcohol|Part B: placebo + alcohol
16181924|NCT01531907|Other|Study visit procedures|"Anthropometric measurements to include:
~Weight, height, and BMI.
~Waist and hip circumference
~Triceps skinfold thickness
~Measurement of supine abdominal thickness A baseline blood sample (15ml)is taken before receiving a standard polycal drink (75g glucose load) Three further blood samples (15 ml) will be taken, at the time points 20, 60 and 120 minutes after glucose loading. In 10 subjects (5 lean and 5 obese) we will take an additional blood sample (up to 50 ml) at baseline into heparin to grow osteoclasts in culture. Visit duration - approximately 3-4 hours."
16181925|NCT01531894|Drug|GSK2110183 (afuresertib)|Afuresertib is an oral, low nanomolar pan-AKT kinase inhibitor immediate release (IR) 50 mg or 75 mg tablets was to be taken orally with at least 200 mL of water, with or without food, in the morning.
16181926|NCT01531868|Other|Video|Video of physician
16181927|NCT01531868|Other|Video|Video of physician
16181928|NCT01531868|Other|Video|Video of physician
16181929|NCT01531868|Other|Video|Video of physician
16181930|NCT01531868|Other|Video|Video of physician
16181931|NCT01531868|Other|Video|Video of physician
16181932|NCT01531855|Other|Reducing post-exercise rapid-acting insulin (insulin lispro or aspart) dose|Dosage after exercise
16181933|NCT01531842|Procedure|Conj flora Antibiotic resistance|Patients will either receive a drop of topical antibiotic before and after the intravitral injection or no topical antibiotics (only typical prep with betadine).
16181934|NCT01531829|Drug|Recombinant tissue plasminogen activator (rt-PA)|Low dose (50mg/2h) rt-PA plus LMWH
16181935|NCT01531829|Drug|Low Molecular Weight Heparin|0.1ml/10kg,q12h,5-7 days
16181936|NCT01531816|Device|Early Rehabilitation intervention|"Passive mobility: cycle ergometer
~Active mobility: interactive video-game (X Box 360 Kinect) Each intervention will be applied for a maximum of 2 days respectively. If a participant is unconscious on Day 1 and receives the passive intervention, and thereafter becomes alert and cooperative on day 2, then he/she can receive the active intervention."
16181937|NCT01531803|Drug|Kedbumin 25%|"Albumin (Human) 25% solution for intravenous (IV) infusion in the dosage strength of 250g human albumin /L, supplied in 50 mL type II vial (each vial containing 12.5g human albumin).
~The dose will be 0.5 to 1g/kg body weight (2 to 4 mL/kg of 25% albumin)."
16181938|NCT01531803|Drug|Normal Saline Solution|Normal (0.9%) saline solution administered via IV infusions of 10 to 20 mL/kg as appropriate per standard of care based on the subject's clinical status and response to treatment.
16181939|NCT01531790|Drug|Carboplatin|d1, AUC 5, i.v.
16181940|NCT01531790|Drug|Pemetrexed|d1, 500 mg/m2, i.v.
16181941|NCT01531790|Drug|Endostar|d2-d21, continuous Endostar intravenous infusion, 7.5 mg/m2/d, 15 mg/m2/d or 30 mg/m2/d, etc.
16181942|NCT01531790|Drug|Centrum|1 tablet/day
16181943|NCT01531777|Drug|Apatinib|500 mg,p.o.,qd, until disease progression or intolerable toxicity or patients withdrawal of consent.
16181944|NCT01531777|Drug|apatinib|750 mg,p.o.,qd, until disease progression or intolerable toxicity or patients withdrawal of consent.
16181945|NCT01531764|Drug|BIBW 2992 in combination with vinorelbine|Patients will receive BIBW 2992 and vinorelbine chemotherapy. BIBW 2992: 40 mg oral (tablet) once daily Vinorelbine: 25 mg/m² on days 1 & 8 in a 3-weekly course, intravenous, short infusion of about 10 minutes
16181946|NCT01531751|Device|High Cut-off Hemodialysis|During dialysis the patients will undergo the first cycle of chemotherapy according to the current standard of care for subjects with advanced cardiac AL amyloidosis. Measurements of FLC and cardiac biomarkers will be done before and after each dialysis session. High cutoff HD will be continued during the first chemotherapy cycle. After the first cycle the end-of-treatment evaluation will take place.
16181947|NCT01531751|Drug|Chemotherapy|Chemotherapy will be based on alchilators, proteasome inhibitors, steroids, IMiDs.
16181948|NCT01531725|Device|Percutaneous coronary intervention|Percutaneous coronary intervention
16181949|NCT01531712|Drug|Gemcitabine|1000mg/m2 / / 40mg/m2
16181950|NCT01531712|Radiation|Radiotherapy|50.4 Gy
16181951|NCT01531712|Drug|Tarceva|100mg/day
16181952|NCT01531712|Drug|Oxaliplatin|100mg/m2 (only in QT)
16181953|NCT01531699|Drug|ALT005 Ophthalmic Prep Solution|single application for up to 6 hours
16181954|NCT01531699|Other|saline control|single application for up to 6 hours
16181955|NCT01531699|Drug|Betadine ophthalmic prep solution|single application for up to 6 hours
16181956|NCT01531686|Procedure|Intraosseous delivery of CT contrast dye|Delivery of CT contrast through intraosseous vascular access at the proximal humerus for CT examination.
16181957|NCT01531673|Drug|VX-661|
16181958|NCT01531673|Drug|Ivacaftor|
16181959|NCT01531673|Drug|Placebo matched to VX-661|
16181960|NCT01531673|Drug|Placebo matched to ivacaftor|
16181961|NCT01531660|Behavioral|step-up jogging program|
16181962|NCT01531647|Drug|danoprevir|100 mg q12h Days 8-21
16181963|NCT01531647|Drug|raltegravir|400 mg q12h Days 1-4 and 18-21
16181964|NCT01531647|Drug|ritonavir|100 mg q12h Days 8-21
16181965|NCT01531634|Behavioral|Dynamic Cognitive Intervention Group|Twelve meetings of a Dynamic Cognitive Intervention group.
16181966|NCT01531621|Other|Biomarker sampling|Blood samples every 8-12 weeks
16181967|NCT01531595|Drug|Bevacizumab plus alternating Xelox/Xeliri|3 cycles of XELOX+bevacizumab alternating with 3 cycles XELIRI+bevacizumab until disease progression
16181968|NCT01531582|Drug|minocycline|The participant's parent or guardian will be instructed to administer minocycline caplets by mouth twice daily. Parents or guardians will be instructed to avoid dairy products, antacids, or any vitamin preparation that contains any divalent or trivalent cations (e.g. Aluminum, Calcium, Magnesium, etc.) for one hour prior to, and two hours after study medication administration.
16181969|NCT01531569|Other|BeneFlax - 38% secoisolariciresinol diglucoside (SDG)|0.8g of BeneFlax (contains 300mg SDG) given once by mouth
16181970|NCT01531543|Device|V.A.C.- Vacuum assisted closure laparostomy (KCI)|Primary Vacuum Assisted Closure (V.A.C.)laparostomy was indicated after surgery in patients with severe peritonitis. VAC laparostomy was performed using sandwich technique (semi-permeable foil - intraabdominal foam - dynamic sutura of the fascia - foam inserted subcutaneously - non-permeable foil) and connected to the active suction of 125mmHg.
16181971|NCT01531530|Biological|CVD 1208S, a Shigella flexneri 2a live, oral vaccine|The vaccine is mixed with salt water and given by mouth.
16181972|NCT01531530|Other|Placebo|Corn starch and baking soda are mixed with salt water and given by mouth.
16182011|NCT01531205|Drug|Androgen Ablation|All patients will receive luteinizing hormone-releasing hormone (LHRH) agonist therapy (leuprolide or goserelin acetate) concurrent with Cabazitaxel, before surgery. A course of bicalutamide 50 mg daily orally for 14-21 days is recommended for patients starting LHRH agonist therapy and suspected to be at risk for tumor flare, e.g., significant obstructive urinary symptoms and will be optional in other patients.
16189869|NCT01472835|Drug|Fentanyl|Used for analgesia and as a sedative
16181973|NCT01531517|Drug|Royal Jelly and Panthenol (PedyPhar® Ointment)|"the following will be done to each patient depending on the number of the visit:
~Assessment of the patient for inclusion/exclusion criteria
~Informed consent process
~Medical history of the patient
~Blood withdrawn for investigation
~Drainage of the ulcer if there is a collection
~Revascularization as needed and indicated by APSV done at visit 0.
~Swab from the ulcer for culture and micro-organism count: on detailed visits only.
~Debridement as needed.
~Dressing:
~Inspection and assessment of the ulcer
~Irrigation using 500 ml of saline or as required.
~Drying of the ulcer (leave to dry)
~Spread a layer of 3 - 5 mm of PedyPhar on a dressing and then apply the dressing to the ulcer
~Fix the dressing to the ulcer"
16181974|NCT01531517|Drug|Panthenol Ointment|"the following will be done to each patient depending on the number of the visit:
~Assessment of the patient for inclusion/exclusion criteria
~Informed consent process
~Medical history of the patient
~Blood withdrawn for investigation
~Drainage of the ulcer if there is a collection
~Revascularization as needed and indicated by APSV done at visit 0.
~Swab from the ulcer for culture and micro-organism count: on detailed visits only.
~Debridement as needed.
~Dressing:
~Inspection and assessment of the ulcer
~Irrigation using 500 ml of saline or as required.
~Drying of the ulcer (leave to dry)
~Spread a layer of 3 - 5 mm of Panthenol on a dressing and then apply the dressing to the ulcer
~Fix the dressing to the ulcer"
16181975|NCT01531504|Device|ViKY UP|laparoscopic-assisted hysterectomy procedure
16181976|NCT01531491|Procedure|Rebreathing tube|750 ml rebreathing tube will be connected between the corrugated tube and the tracheal tube of a patient. Target partial pressure of the end-tidal carbon dioxide is 50 mmHg.
16181977|NCT01531491|Procedure|No rebreathing tube (Nothing)|750 ml rebreathing tube will not be connected between the corrugated tube and the tracheal tube of a patient. Target partial pressure of the end-tidal carbon dioxide is 30 mmHg.
16181978|NCT01531478|Other|Unique medical visit of the study|"The visit will be with an oncologist specialized in the long-term follow-up of cured pediatric cancer patients. The examination will consist in weight and height measurements, a clinical examination and a measurement of arterial pressure. The list of drugs taken in the last two years, as well as all health issues encountered since the cancer treatment, will be collected. Success in education, career and, family status will also be discussed.
~After the medical examination, patients will be offered a visit with a psychologist in order to assess their psychopathological outcomes. This questionnaire is a interquestionnaire designed to screen axis I psychopathological conditions. It includes an evaluation of all types of risk-taking behavior (alcohol, drugs, anorexia and bulimia)."
16181979|NCT01531465|Other|Pulmonary Function Testing & esophageal pressure monitoring|Infants who are currently on NCPAP will have pulmonary function testing (PFTs)and esophageal pressure performed while on 2 different settings of NCPAP. These infants will then be transitioned HFNC and will undergo PFTs and esophageal pressure while on different HFNC settings. The infant will then be returned to NCPAP at the same settings they were on prior to any study interventions.
16181980|NCT01531465|Other|Pulmonary function testing and esophageal pressure|Infants who are currently on HFNC will have pulmonary function testing (PFTs) and esophageal pressure performed while on 2 different settings of HFNC. These infants will then be transitioned NCPAP and will undergo PFTs and esophageal pressure while on 2 different NCPAP settings. The infant will then be returned to HFNC at the same settings they were on prior to any study interventions.
16181981|NCT01531452|Drug|Oxaliplatin|130mg/m2 d1,repeated q21d
16181982|NCT01531452|Drug|s1|80mg/m2/d, d1-14,repeated q21d
16181983|NCT01531439|Drug|Naloxone|Naloxone infusion 0.5 mcg/kg/hr
16181984|NCT01531439|Drug|Naloxone|Naloxone infusion 2.5 mcg/kg/hr
16181985|NCT01531426|Device|near infrared spectroscopy (INVOS®, Covidien)|Measurement of regional cerebral oxygen saturation with non-invasive near-infrared INVOS® (In-Vivo Optical Spectroscopy) monitor by Covidien.
16181986|NCT01531413|Other|Oxygen Insufflation|At the end of the case, abdomen will be desufflated with CO2 then insufflated with oxygen
16181987|NCT01531400|Other|self-selected music|Investigators played self-selected background music in the music group
16181988|NCT01531387|Drug|Hydroxyurea|Hydroxyurea will be administered once daily, in either capsule form (300mg, 400mg, or 500mg) or as a liquid formulation (100mg/ml). Dosing will commence at 20 mg/kg/day. Dose escalation will occur in 5 mg/kg/day increments, adjusting every 8 weeks unless hematological toxicity occurs.
16181989|NCT01531374|Device|Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)|
16181990|NCT01531361|Drug|Crizotinib|Given PO
16181991|NCT01531361|Other|Laboratory Biomarker Analysis|Correlative studies
16181992|NCT01531361|Other|Pharmacological Study|Correlative studies
16181993|NCT01531361|Drug|Sorafenib Tosylate|Given PO
16181994|NCT01531361|Drug|Vemurafenib|Given PO
16181995|NCT01531348|Other|BM-MSC|Bone marrow-derived mesenchymal stem cells 1 million cells in balanced salt solution 100 microlitres will be injected into the vitreous cavity.
16181996|NCT01531335|Dietary Supplement|Hypocaloric hyperproteic nutrition|15 kcal per kg of body weight and 1.7 grams of protein per kg.
16181997|NCT01531335|Dietary Supplement|Standard care|25 kcal per kg of body weight
16181998|NCT01531322|Biological|13-valent Pneumococcal Conjugate Vaccine|suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
16181999|NCT01531322|Biological|13-valent Pneumococcal Conjugate Vaccine|suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
16182000|NCT01531322|Biological|13-valent Pneumococcal Conjugate Vaccine|suspension in prefilled syringe for intramuscular injection, 0.5 mL, only one dose
16182001|NCT01531309|Drug|AGO178|AGO178 is administered as a sublingual tablet.
16182002|NCT01531283|Drug|unacylated ghrelin|IV, UAG (4.0 µg/kg/hr), one time, duration of study visit (approximately 5 hours)
16182003|NCT01531283|Drug|acyl ghrelin|IV, AG (1.0 µg/kg/hr), one time, duration of study visit (approximately 5 hours)
16182004|NCT01531283|Drug|combined acyl and desacyl ghrelin|IV, the combination of AG (1 µg/kg/hr) and UAG (4 µg/kg/hr), one time, for the duration of the study visit (approximately 5 hours)
16182005|NCT01531283|Drug|saline|IV, saline, one time, for the duration of the study visit(approximately 5 hours)
16182006|NCT01531244|Biological|dactinomycin|Given via ILI
16182007|NCT01531244|Drug|melphalan|Given via ILI
16182008|NCT01531244|Biological|Conditionally replicative adenovirus 3/5-delta|Given via ILI
16190310|NCT01469416|Drug|Rosuvastatin|Rosuvastatin 20 mg PO x 1
16182012|NCT01531205|Drug|Cabazitaxel|Intravenous treatment with Cabazitaxel 25 mg/m^2 is given on day 1 every 21 days. A cycle of chemotherapy will be defined as 21 days. A total of four cycles of combination therapy are planned for a total duration of 12 weeks (before surgery), starting within 3 weeks of protocol entry, to be given concurrent with hormone therapy.
16182013|NCT01531205|Drug|Salvage Therapy|Patients will undergo 4 cycles of chemotherapy in conjunction with LHRH agonist therapy (before surgery) subsequent to which they will have their serum Prostate-specific antigen (PSA), bone scan, abdominal pelvic computed tomography (CT) or magnetic resonance imaging (MRI) repeated. Patients with a detectable metastatic diseases will be removed from the study. Salvage surgery will be performed within 8 weeks after the completion of Cabazitaxel chemotherapy. For patients who achieved undetectable PSA following surgery, androgen deprivation therapy will be discontinued.
16182014|NCT01531205|Drug|Neoadjuvant Treatment - Hormonal Therapy|All treatment will be given on an outpatient basis. Treatment should start within 3 weeks of protocol entry. All patients will receive androgen ablation with LHRH agonist therapy in conjunction with the 4 cycles of Cabazitaxel for neoadjuvant chemohormonal therapy. Androgen ablative therapy will be discontinued before surgery. A course of bicalutamide 50 mg daily orally for 14-21 days is recommended for patients starting LHRH agonist therapy and suspected to be at risk for tumor flare, e.g., significant obstructive urinary symptoms and will be optional in other patients.
16182015|NCT01531205|Drug|Neoadjuvant Treatment - Cabazitaxel|"All treatment will be given on an outpatient basis and should start within 3 weeks of protocol entry. Intravenous treatment with Cabazitaxel is given on Day 1 every 3 weeks. A cycle of combination therapy will be defined as 3 weeks. A total of 4 cycles of combination therapy are planned before surgery for a total duration of 12 weeks.
~Cabazitaxel will be administered before surgery by one-hourly infusions via central or peripheral intravenous access at a dose of 25 mg/m^2 as a one hour intravenous infusion in combination with oral prednisone 10 mg administered daily throughout Cabazitaxel treatment. It is advised that all patients receiving Cabazitaxel have a reliable form of venous access, e.g., central venous catheter to ensure their ability to receive therapy without undue delay."
16182016|NCT01531192|Dietary Supplement|Lactobacillus reuteri|Lactobacillus reuteri 100 million CFU/day for 3 months
16182017|NCT01531192|Drug|Nystatin|50000 unit/3 times a day, both for orally and by orogastric route
16182018|NCT01531179|Drug|Lactobacillus reuteri|Lactobacillus reuteri 100 million CFU/day for 3 months
16182019|NCT01531179|Drug|Placebo|Placebo for 3 months
16182020|NCT01531166|Drug|pegylated Interferon-alpha 2a|Pegasys 180mcg/PFS/ subcutaneous injection / Once a week
16182021|NCT01531153|Drug|Galantamine|8mg or 16mg
16182022|NCT01531153|Drug|Placebo|Placebo dose.
16182023|NCT01531140|Drug|polyethylene glycol +Bisacodyl|Polyethylene glycol (Fortrans) p.o. 30 ml/kg/2days + Bisacodyl p.o.10-15 mg/day for 2 days
16182024|NCT01531140|Drug|Polyethylene glycol|Polyethylene glycol p.o.: 60 ml/kg/days
16182025|NCT01531140|Drug|Sennosides|Sennosides 1tbl/8kg for 2 days
16182026|NCT01531114|Drug|ticagrelor|Patients will be randomized to this arm to receive loading dose of ticagrelor
16182027|NCT01531114|Drug|prasugrel|Patients will be randomized to this arm to receive loading dose of prasugrel
16182028|NCT01531101|Behavioral|Individual psychodynamic psychotherapy|Individual psychodynamic psychotherapy with or without transference work. I.e. with or without relational therapist interventions focusing on the patient-therapist relationship.
16182029|NCT01531088|Behavioral|Active medication monitoring|Active medication monitoring system providing consultant pharmacists with alerts representing potential adverse drug events.
16182030|NCT01531075|Biological|ENGERIX-B (HBV Vaccine)|ENGERIX-B (Hepatitis B Vaccine) 20 mcg, A series of 3 doses (1 mL each) given on a 0-, 1-, 6-month schedule.
16182031|NCT01531075|Biological|Sci-B-Vac|Sci-B-Vac (Hepatitis B Vaccine) 10 μg/ml, A series of 3 doses (1 mL each) given on a 0-, 1-, 6-month schedule.
16182032|NCT01531062|Drug|Nigella sative|Nigella sativa seed extracts, 300 mg capsule bid, for 56 days
16182033|NCT01531062|Dietary Supplement|black sticky rice|300 mg capsule bid, 56 days
16182034|NCT01531049|Drug|varenicline|days 1.-3 0,5mgx1/day, days 4.-7 0,5mgx2/day, day 8 to the 12weeks 1mgx2 /day
16182035|NCT01531049|Drug|Nicotine cutaneous patch 15mg/16h|One patch for 16hours/day and duration of 8 weeks.
16182036|NCT01531049|Drug|Nicotine cutaneous patch 10mg/16h|One patch 16hours/day and duration of 8 weeks
16182037|NCT01531049|Other|Placebo cutaneous patch|No active medication.O ne patch 16hours and duration for 8 weeks
16182038|NCT01531036|Device|3D Ultrasound elastography by means of shear wave propagation into breast tissue|Aixplorer Supersonic Imagine Ultrasound System with 3D probe for real-time elastography
16182039|NCT01531010|Device|Ventilation protocol delivered by the SLE5000 ventilator|"In pressure-limited ventilation arm, preferentially wean pressure till weaning criteria achieved, then wean rate.
~In volume-targeted ventilation arm, set target volume at 5ml/kg and wean rate. In both arms, aim to keep blood gases within normal limits."
16182040|NCT01530997|Radiation|Intensity Modulated Radiotherapy (IMRT)|All patients will receive IMRT. Dose painting IMRT will be used and all doses will be specified to the planning target volume (PTV). The high risk planning target volume (PTV-HR) and standard risk planning target volume (PTV-SR) will be treated to the following respective total doses: 60 Gy and 54 Gy. The dose per fraction to the PTV-HR and PTV-SR will be 2 Gy per day and 1.8 Gy per day, respectively. The PTV-HR will include the gross tumor and the PTV-SR will include the lymph nodes at risk for harboring micro-metastatic disease (i.e. subclinical disease).
16182041|NCT01530997|Drug|Cisplatin|Cisplatin, 30mg/m2, will be given intravenously over 60 minutes weekly during IMRT; 6 total doses for a total of 180 mg/m2. It is preferred that the doses be administered on days 1, 8, 15, 22, and 29, and 36 of IMRT; however, this is not mandatory.
16182042|NCT01530997|Procedure|Limited surgical evaluation|4 to 14 weeks after completion of CRT, patients will have at least a biopsy of the primary tumor and limited neck surgery to remove those lymph nodes that were involved with cancer prior to CRT.
16182043|NCT01530984|Drug|Ipilimumab|Ipilimumab 3 mg/kg on day 1 of a 28 day cycle for 6 cycles.
16182044|NCT01530984|Drug|GM-CSF|GM-CSF 250 mcg/m2 SQ on days 1-14 for 6 cycles.
16182045|NCT01530971|Drug|Supplemental 3LPM oxygen via canula|Parturients will receive supplemental oxygen (3LPM) via nasal canula
16182248|NCT01529541|Drug|Anagliptin|Anagliptin 100mg, tablet, twice a day (BID)
16182046|NCT01530958|Behavioral|CKD Registry|"Primary care providers (PCPs) will have access to a Chronic Kidney Disease (CKD) registry for patient care. The registry will:
~identify patients with CKD
~notify PCPs of a patients' CKD status
~provide PCP outreach with NKDEP guidelines and patient educational materials"
16182047|NCT01530958|Behavioral|ATSM + Health Coach|Patients with CKD will participate in an Automated Telephone Self Management (ATSM) program, which blends automated phone calls with live targeted call-backs from a health coach. Patients will receive bi-weekly automated calls for 52 weeks in their native language, consisting of pre-recorded queries pertaining to CKD management, preventive services, and lifestyle changes. Patients will interact with the system using a touch-tone keypad; Out-of-range values or invalid responses will prompt a live call-back within 24-48 hours by a health coach.
16182048|NCT01530958|Behavioral|Usual care|"Primary care providers will manage their patients with CKD per usual care.
~Patients will receive usual care."
16182049|NCT01530919|Procedure|Minimally invasive radioguided parathyroidectomy|After the patient is prepared for surgery and under local anesthesia, the initial incision by the surgeon will be 2-3 cm. The surgeon will dissect in the designated quadrant until the parathyroid gland is identified.
16182050|NCT01530906|Procedure|Repetitive transcranial Magnetic Stimulation (rTMS)|10 TMS sessions of 20 trains of 5s with 55s interval cross train, at a frequency of 10 Hz and 110% of motor threshold intensity of the left DLPFC.
16182051|NCT01530906|Procedure|Repetitive transcranial Magnetic Stimulation SHAM|Sham treatment will be performed with a placebo coil. The same coil as coil used for rTMS, but it does not deliver magnetic field.
16182052|NCT01530893|Dietary Supplement|Flavanone - supplement|acute single optimal dose
16182053|NCT01530893|Other|Flavanone - food|acute single dose
16182054|NCT01530893|Other|Flavanone - placebo|acute single dose (flavanone free)
16182055|NCT01530893|Dietary Supplement|Isoflavone - supplement|acute single optimal dose
16182056|NCT01530893|Other|Isoflavone - food|acute single optimal dose
16182057|NCT01530893|Other|Isoflavone - placebo|acute single dose (isoflavone free)
16182058|NCT01530893|Dietary Supplement|Isoflavone - metabolite supplement|acute single optimal dose of commercial product
16182059|NCT01530893|Dietary Supplement|Flavan-3-ol - supplement|acute single optimal dose
16182060|NCT01530893|Other|Flavan-3-ol - food|acute single optimal dose
16182061|NCT01530893|Other|Flavan-3-ol - placebo|acute single dose (flavan-3-ol free)
16182062|NCT01530893|Dietary Supplement|Anthocyanin - supplement|acute single optimal dose
16182063|NCT01530893|Other|Anthocyanin - food|acute single optimal dose
16182064|NCT01530893|Other|Anthocyanin - placebo|acute single dose (anthocyanin free)
16182065|NCT01530880|Drug|Intravenous Ibuprofen|Ibuprofen 400 mg/100 mL intravenous (IV) over 30 minutes, followed by a continuous infusion of 2000 mg/500 mL at 85 mg/hour (21 mL/hour) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first
16182066|NCT01530880|Drug|Acetaminophen (Standard of Care)|Acetaminophen 650 mg via oral/nasogastric tube every 6 hours as needed for T>=38.3 C (100.9 F) for up to post bleed day 14 or discharge from the Neuro ICU, whichever comes first.
16182067|NCT01530841|Device|Nocturnal ventilation|Home ventilation only the mode AVAPS will be used if the patient is randomized in the experimental group.
16182068|NCT01530815|Drug|Bupivicaine Infusion|Investigators and Caregivers will be blinded to either 0.9% Normal Saline or 0.5% Bupivicaine infusion between the mesh and abdominal wall
16182069|NCT01530802|Procedure|clipping of uterine arteries during laparoscopic myomectomy|For laparoscopy standard instruments were used.For vascular clamping we used titan made YASARGIL vessel clips. The patient is put in a 20° Trendelenburg. The surgeon coagulates a 3-4 cm long segment of peritoneum over the ileopsoas muscle. Along the coagulated segment the peritoneum is opened. The surgeon identifies the ureter at its crossing over the common iliac vessels. After medializing the ureter, the pararectal space is opened and the internal iliac artery is identified and dissected till the origin of the uterine artery. The uterine artery is isolated over a distance of about 2 cm. The vascular clip is placed over the uterine artery. Yasargil Clips are applied exclusively in patients of intervention group. Myomectomy is performed in identical fashion in both groups. At the end of myomectomy the vessel clips are removed. The metroplasty is controlled for hemostasis after reopening of the uterine vessels.
16182070|NCT01530776|Behavioral|Healthy Lifestyle Group|Electronically-mediated, behavioral intervention during and after pregnancy encouraging mothers to eat healthy, exercise, and return to their early pregnancy weights by 1 year postpartum
16182071|NCT01530763|Drug|Ceftaroline fosamil|"Treatment Group 1:
~Drug: Ceftaroline fosamil Children ≥ 6 months: IV ceftaroline fosamil 12 mg/kg for subjects weighing ≤ 33 kg or 400 mg for subjects weighing > 33 kg will be infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour)
~Children < 6 months: Ceftaroline fosamil 8 mg/kg over 60 (± 10) minutes q8h (± 1 hour)"
16182072|NCT01530763|Drug|Ceftriaxone|"Treatment group 2:
~75 mg/kg/day up to 4 g/day IV in equally divided doses, each infused over 30 (± 10) minutes q12hr (± 2 hours)"
16182073|NCT01530763|Drug|amoxicillin clavulanate|"Oral Switch for Treatment Groups 1 and 2:
~PO amoxicillin clavulanate 90 mg/kg/day divided q12h in subjects with infections due to susceptible organisms on or after Study Day 4 (a minimum of 7 IV doses required if randomized to ceftaroline.)"
16182074|NCT01530737|Drug|Antithrombin III|Patients randomized to receive Antithrombin concentrate will receive a dose of AT to achieve a target value of 1.2U/ml.
16182075|NCT01530737|Other|Saline Placebo|Patients randomized to the control group will receive a placebo consisting of normal saline in a volume equivalent to the volume of antithrombin the same patient in the treatment group would have received and administered by anesthesia and perfusion in the exact same manner as the AT is administered in the treatment group.
16182076|NCT01530724|Other|Weight-loss diet strategy (+) exercise (PA)|Weight-loss diet strategy with a free gym membership; monthly 60-minute educational workshops; 3 sessions of workout per week of mostly aerobic training
16182077|NCT01530724|Other|weight loss (-) exercise (PA)|Weight-loss diet strategy without exercise
16182078|NCT01530711|Drug|Terlipressin and albumin|"Terlipressin dose: 2mg/24h, it will be modified depending on: Arterial pressure increase < 10 mmHg and the creatinine values decrease <25%, it will be increased every 8 hours until reaching an increase of at least 10mmHg arterial pressure or a creatinine decrease of the 25%.
~Albumin: Initial dose (first day) of 1g/Kg (up to a maximum of 100g) and the following days from 20 to 40 g/day."
16182079|NCT01530698|Biological|autologous dendritic cell vaccine|Autologous monocyte-derived dendritic cells electroporated with mRNA encoding gp100 and tyrosinase (for antigen loading), active TLR4 and CD70 (for activation). Dendritic cells are vaccinated intranodally 3 times with biweekly intervals every 6 months, if no signs of progression, for a total of 9 vaccinations
16182080|NCT01530698|Biological|autologous dendritic cell vaccine|Autologous monocyte-derived dendritic cells electroporated with mRNA encoding gp100 and tyrosinase and matured with either cytokines or TLR ligands. Dendritic cells are vaccinated intranodally 3 times with biweekly intervals every 6 months, if no signs of progression, for a total of 9 vaccinations
16182081|NCT01530685|Dietary Supplement|Glycabiane|2 gelule per day for 4 months
16182082|NCT01530685|Dietary Supplement|placebo|2 gelules per day for 4 months
16182083|NCT01530672|Device|MBIO POC combined HIV syphilis test ( SnapEsi)|Venipuncture for routine ANC screening plus additional for device validation purposes.
16182084|NCT01530659|Drug|NT-501|Study participants will undergo surgery to have an NT-501 Encapsulated Cell Therapy implant placed into the study eye.
16182085|NCT01530659|Procedure|Sham|Non-penetrating sham procedure to mimic implant procedure in the other eye.
16182086|NCT01530646|Behavioral|Weight loss|-750kcal/d
16182087|NCT01530646|Dietary Supplement|Soy|2 x 25g/d SPC
16182088|NCT01530646|Dietary Supplement|Whey|2 x 25g/d WPI
16182089|NCT01530620|Drug|Propiverine hydrochloride ER (extended release)|45 mg capsule (1x1/d)
16182090|NCT01530620|Drug|Propiverine hydrochloride IR (immediate release)|15 mg tablet (3x1/d)
16182091|NCT01530607|Drug|Standard cyclophosphamide|AC (3 mos/4 cycles), CAF (6 mos/cycles), TAC (6 mos/cycles), CEF (6 mos/cycles) AC followed by taxane (6 mos/8 cycles), CMF (6 mos)
16182092|NCT01530607|Drug|Goserelin (Zoladex)|Chemotherapy in Arm 1 plus Goserelin given one week before first chemotherapy dose. Goserelin is given once every 4 weeks during chemo
16182093|NCT01530594|Drug|Lenalidomide/Low dose Dex|Lenalidomide/Low dose Dex (LLD)
16182094|NCT01530594|Drug|Bortezomib/Lenalidomide/ Low dose Dex|Bortezomib/Lenalidomide/ Low dose Dex (BLLD)
16182095|NCT01530594|Drug|Lenalidomide|Lenalidomide/Low dose Dex (LLD
16182096|NCT01530581|Procedure|G-PB Transplant|G-PB Transplant
16182097|NCT01530581|Procedure|G-BM Transplant|G-BM Transplant
16182098|NCT01530568|Other|Xpert|This arm receives the GeneXpert test
16182099|NCT01530568|Other|Smear|This arm receives smear microscopy
16182100|NCT01530555|Drug|Rabbit ATG, Thymoglobuline (Genzyme)|"Rabbit ATG, Thymoglobuline® (Genzyme) 1.5 vials/10kg (3.75mg/kg) daily for 5 days given as an intravenous infusion over 12-18 hours.
~Ciclosporin (CSA) 5mg/kg/day orally from day +1 for a minimum of 6 months"
16182101|NCT01530542|Drug|oxycodone hydrochloride|oxycodone hydrochloride 5 mg tablet under fasted conditions
16182102|NCT01530542|Drug|oxycodone hydrochloride|2 x oxycodone hydrochloride 5 mg tablets under fasted conditions
16182103|NCT01530542|Drug|oxycodone hydrochloride|2 x oxycodone hydrochloride 7.5 mg tablets under fasted conditions
16182104|NCT01530542|Drug|oxycodone hydrochloride|2 x oxycodone hydrochloride 7.5 mg tablets under fed conditions
16182105|NCT01530542|Drug|marketed oxycodone hydrochloride|1 x oxycodone hydrochloride 15 mg tablet under fed conditions
16182106|NCT01530529|Drug|PF-05180999|Single dose of 30 mg of PF-05180999 administered to fasted subjects as an immediate-release powder-in-capsule formulation
16182107|NCT01530529|Drug|PF-05180999|Single dose of 30 mg of PF-05180999 administered to fasted subjects as a modified-release formulation
16182108|NCT01530529|Drug|PF-05180999|Single dose of 120 mg of PF-05180999 administered to fasted subjects as a modified-release formulation
16182109|NCT01530529|Drug|PF-05180999|Single dose of 30 mg of PF-05180999 administered to fed subjects as a modified-release formulation
16182110|NCT01530516|Device|Brackets plus Forsus springs|Full brackets and after completion of level and alignment insertion of Class II correctors (Forsus spring devices).
16182111|NCT01530516|Device|Xbow plus full brackets|Xbow appliance to be inserted first. After anteroposterior changes have been completed full brackets will be bonded and occlusion fine tuned
16182112|NCT01530503|Drug|capecitabine and mitomycin|"oral capecitabine 2000 mg/m2 day 1-14 in two divided doses taken with food plus bolus IV infusion mitomycin C 6 mg/m2 day 1.
~Cycles will be repeated in both arms every 3 weeks till progression, unacceptable toxicity, medical decision or patient's refusal or for a maximum of 6 months"
16182113|NCT01530503|Drug|Capecitabine|"oral capecitabine 2000 mg/m2 day 1-14 in two divided doses taken with food.
~Cycles will be repeated in both arms every 3 weeks till progression, unacceptable toxicity, medical decision or patient's refusal or for a maximum of 6 months"
16182114|NCT01530490|Drug|Cabergoline and Hydroxyethyl Starch|0.5mg
16182115|NCT01530490|Drug|Hydroxyethyl Starch|0.5 mg cabergoline administration 8 days
16182116|NCT01530477|Device|Lunar Prodigy (GEHC)|Lunar Prodigy (GEHC) used to obtain Skeletal, and/or Body Composition measurements
16182117|NCT01530477|Device|Lunar iDXA (GEHC)|Lunar iDXA (GEHC) used to obtain Skeletal, and/or Body Composition measurements
16182118|NCT01530477|Device|Discovery A (Hologic|Discovery A (Hologic) used to obtain Skeletal, and/or Body Composition measurements
16182119|NCT01530464|Drug|Aminophylline|Drug will be administered as a single oral dose of 500mg, followed by a 48h washout period.
16182120|NCT01530464|Drug|Ambrisentan|Drug will be administered as a single dose of 5mg, followed by a 48h washout period
16182121|NCT01530464|Drug|Aminophylline plus ambrisentan|Drugs will be given as single doses of 500mg (aminophylline) and 5mg (ambrisentan), followed by a 48h washout period
16182122|NCT01530451|Drug|Desmopressin|120mg OD
16182123|NCT01530451|Drug|Placebo|one tab OD
16182124|NCT01530438|Other|MRI + 18FDG-PET + neuropsychological assessments ; 18FDG performed especially for the research|"At T0 and T9 or 12 monts, are performed :
~Imaging : fMRI at rest and anatomical MRI
~Neuropsychological assessments : general cognitive functioning, theory of mind, executive functions ..."
16182125|NCT01530412|Other|Pulmonary Rehabilitation|Patients undergo pulmonary rehabilitation for two hours twice a week for seven weeks. The first hour comprises of an individualized exercise programme and the second hour consists of an educational component. Patients are also required to undergo inspiratory muscle training five days a week for thirty minutes and exercise for an additional three days a week for thirty minutes.
16182126|NCT01530399|Drug|MDCO 1|MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 1: load 15 μg/kg; infusion 30 μg/kg/h; CPB prime 0.11 μg/mL priming volume
16182127|NCT01530399|Drug|MDCO 2|MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 2: load 30 μg/kg; infusion 60 μg/kg/h; CPB prime 0.22 μg/mL priming volume
16182128|NCT01530399|Drug|MDCO 3|MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 3: load 60 μg/kg ; infusion 120 μg/kg/h; CPB prime 0.44 μg/mL priming volume
16182129|NCT01530399|Drug|MDCO 4|MDCO-2010 will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with MDCO-2010. MDCO 4: load 90 μg/kg; infusion 180 μg/kg/h; CPB prime 0.65 μg/mL priming volume
16182130|NCT01530399|Drug|Tranexamic Acid|Tranexamic acid will be administered as a loading dose followed by a continuous infusion until sternal closure. In addition, the CPB reservoir will be primed with tranexamic acid. The flow rates will be the same as for MDCO-2010.
16182131|NCT01530399|Drug|Saline|A loading dose of saline will be followed by a continuous infusion of saline until sternal closure. In addition, the CPB reservoir will be primed with saline. The flow rates will be the same as for MDCO-2010.
16182132|NCT01530386|Drug|Lacosamide|Lacosamide will be given orally in 50 mg tablets twice a day for 7 days. The dose will increase weekly by 100 mg per day to a target dose of 300 mg per day. Once the target dose of 300 mg per day has been achieved for 9 days, a 2-day tapering of Lacosamide will occur by 100 mg per day.
16182133|NCT01530373|Drug|solifenacin|oral solifenacin 5.0 mg daily for 3 weeks
16182134|NCT01530373|Drug|Clonidine|oral clonidine 0.1 mg daily for 3 weeks
16182135|NCT01530360|Device|cerebral oximeter|INVOS 5100c + SAFB-SM SOMASENSOR NONIN EQUANOX 7600 + sensor model 8000CA
16182136|NCT01530347|Device|Easy Check|Collection of paired measurements of capillary blood glucose using reference method and data generated by the non invasive study device. Samples will be obtained at specific time points during 4 hours: at fasting, and after consuming standard liquid meal at 60, 120, 180 and 240 minutes.
16182137|NCT01530334|Drug|Gefitinib 250mg|Gefitinib 250mg once daily
16182138|NCT01530321|Other|Spinal Manipulation|5 minutes of high velocity, low amplitude thrust to cervical and upper thoracic spine.
16182139|NCT01530321|Other|Light Massage|5 minutes of light pressure massage to the neck and upper back
16182140|NCT01530308|Drug|Haloperidol|An oral dosage of 1mg twice daily at 12am and 8pm.
16182141|NCT01530308|Drug|Placebo|An oral dosage of 1mg twice-daily at 12am and 8 pm.
16182142|NCT01530295|Drug|DOCETAXEL|75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle. Number of Cycles: 3 times pre-op and 3 times after surgery
16182143|NCT01530282|Other|Invasive method|Esophageal and gastric catheters to measure respiratory mechanics (static and dynamic)
16182144|NCT01530282|Other|Non invasive method|Non_invasive method: airway pressure measured during a 150-200 ms at the beginning of inspiration
16182145|NCT01530269|Drug|C11-Sodium Acetate|PET Imaging with C11-Sodium Acetate
16182146|NCT01530256|Biological|ALD518|160 mg IV q 4 weeks for 4 doses
16182147|NCT01530256|Biological|ALD518|320 mg IV q 4 weeks for 4 doses
16182148|NCT01530256|Biological|ALD518|640 mg IV q 4 weeks for 2 doses
16182149|NCT01530243|Drug|Placebo|same as tolterodine and terazosin dose
16182150|NCT01530243|Drug|Terazosine|2 mg BID
16182151|NCT01530243|Drug|Tolterodine|2 mg daily
16182152|NCT01530243|Drug|Tolterodine + Terazosin|2mg daily and 2mg BID
16182153|NCT01530230|Drug|oxytocin|Intravenous bolus dose given during 1 minute after clamping of the umbilical cord
16182154|NCT01530217|Drug|Ibuprofen.|Ibuprofen Group will be receive a dose of non-steroidal antiinflammatory drug ibuprofen 400 mg. All the participants will be watched to ensure that they took the drugs 1 hour prior to treatment. A second dose of ibuprofen (400 mg), will be administered a every 8 hours after the first dose during 48 hours.
16182155|NCT01530204|Procedure|Physical Therapy for knee OA|8-12 sessions of knee-focused physical therapy and a home-based conditioning program.
16182156|NCT01530204|Behavioral|Cognitive Behavioral Therapy for Pain CBT-P|8-12 session pain-focused Cognitive Behavioral Therapy
16182157|NCT01530204|Other|Enhanced Treatment as Usual|Information about state-of-the-art pharmacotherapy for osteoarthritis is communicated to the primary care physicians of participants.
16182158|NCT01530178|Drug|Sitagliptin|In each intervention arm the participant receives a different dose of sitagliptin.
16182159|NCT01530178|Drug|Placebo Oral Tablet|
16182160|NCT01530165|Behavioral|Life style counseling|The main goals of intervention will focus mainly on: Weight reduction ≥ 5% , moderate intensity physical activity ≥ 30 min daily, dietary fat <30 proportion of total energy, saturated fat <10%, Fiber ≥ 15g/1,000 kcal There will be 9 sessions during the two years course of follow-up
16182161|NCT01530152|Procedure|Truwiev PCD laryngoscope|"The aim of the method evaluation study is a comparing study of Truview PCD™ laryngoscope vs. Macintosh laryngoscope. The result of this study will form a basis for a possible recommendation of the Truview PCD™ laryngoscope in our organisation.
~The laryngoscopes are compared according to their ability to visualize the glottis area measured by the Cormack Lehane (CL) grade and the time used to get the best CL grade. (See figure 1.) A registration of any damage of tissue/teeths caused by the laryngoscopes, and a possible decrease of the saturation will also be made."
16182162|NCT01530139|Behavioral|Level 1|Level 1 - Participants will receive personalised dietary advice based on their dietary intake data alone.
16182163|NCT01530139|Behavioral|Level 2|Level or Group 2: Participants will receive personalised dietary advice taking dietary intake and phenotypic data into account.
16182164|NCT01530139|Behavioral|Level 3|Level or group 3: Participants will receive personalised dietary advice taking dietary intake, phenotypic and genotypic data into account.
16182165|NCT01530139|Behavioral|Level 0|Level 0 - Control group - Investigators will provide non-personalized dietary advice for improved food choice based on standard population healthy eating guidelines.
16182166|NCT01530126|Biological|B-TCP + 0.3 mg/ml rhPDGF-BB in buffer|B-TCP mixed with sodium acetate buffer and 0.3 mg/ml rhPDGF-BB and placed into osseous defect once at baseline visit.
16182167|NCT01530126|Biological|B-TCP + 1.0 mg/ml rhPDGF-BB in buffer|B-TCP mixed with sodium acetate buffer and 1.0 mg/ml rhPDGF-BB and placed into osseous defect once at baseline visit.
16182168|NCT01530126|Biological|B-TCP +buffer|B-TCP mixed with sodium acetate buffer and placed into osseous defect once at baseline visit.
16182169|NCT01530087|Device|CASTLE barrier|Prototype barrier to be used in place of current two piece device
16182170|NCT01530074|Procedure|Temporary blocking of mandibular nerve|IM. Lidocaine 2% 7.2ML
16182171|NCT01530061|Other|Egg Breakfast|Egg, Toast and Jelly
16182172|NCT01530061|Other|Bagel Breakfast|Bagel, Cream Cheese and Yogurt
16182173|NCT01530048|Drug|insulin aspart|A single bolus injection of 0.2 U/kg administered subcutaneously (s.c., under the skin) on two separate dosing visits with a wash-out period 2-15 days in-between
16182174|NCT01530035|Other|physical training|training
16182175|NCT01530022|Drug|Lacosamide (LCM)|"LCM 300 mg:
~LCM 50 mg and LCM 100 mg white, film-coated oral tablets and Carbamazepine Immediate Release (CBZ-IR) matching placebo capsules.
~Two times daily (morning and evening) during the first 2 weeks of each Titration Period and during the Taper Phases.
~Three times daily (morning, mid-day, and evening) during last week of each Titration Period and 3-week Treatment Period"
16182176|NCT01530022|Drug|Carbamazepine Immediate Release (CBZ-IR)|"CBZ-IR 600 mg:
~CBZ-IR 200 mg oral tablets over-encapsulated to double-blind capsules with an overfill.
~LCM matching placebo tablets two times daily (morning and evening) during the first 2 weeks of each Titration Period and during the Taper Phases.
~Three times daily (morning, mid-day, and evening) during last week of each Titration Period and 3-week Treatment Period."
16182177|NCT01530009|Drug|Amoxicillin|A liquid preparation of amoxicillin will be administered via a nasoduodenal catheter as a one time dose of 20 mg/kg.
16182178|NCT01530009|Other|Placebo|A liquid placebo will be administered via nasoduodenal catheter to patients based on random assignment.
16182179|NCT01529996|Procedure|Pulse Dye Laser/YAG laser|This study involves treatments with two types of lasers, Pulsed dye lasers (PDL) and the 1064 nm Nd: YAG. Both lasers are FDA approved to treat vascularities in the skin.
16182180|NCT01529983|Procedure|Laser treatment|The treated sites are both lower eyelids and lateral orbits. Each side will be randomized to receive 1550nm-fractionated laser treatment on one side and the contralateral side will receive micro-focused ultrasound treatment every 6-8 weeks for a total of 2 treatments
16182181|NCT01529957|Drug|Nemonoxacin Malate Sodium Chloride|Nemonoxacin Malate Sodium Chloride,intravenous injection,once daily
16182182|NCT01529944|Drug|somatropin|Results from a genetic testing for the PTPN11 mutation will be collected retrospectively for 24 subjects with Noonan syndrome previously treated with somatropin in accordance with the S/GHD/004/N00 protocol and in the follow-up trial GHNOO-1658.
16182183|NCT01529944|Drug|somatropin|Results from a genetic testing for the PTPN11 mutation will be collected retrospectively for 24 subjects with Noonan syndrome previously treated with somatropin in accordance with the S/GHD/004/N00 protocol and in the follow-up trial GHNOO-1658.
16182184|NCT01529931|Device|Hair2Go|Hair2Go treatment once a month for 6 months
16182185|NCT01529918|Other|CANRISK (Canadian Diabetes Association Assessment)|Self-risk assessment questionnaire for diabetes
16182186|NCT01529892|Drug|A single oral 5 mg of duterium labeled methamphetamine|
16182187|NCT01529879|Device|New Abutment Connection implant|New abutment connection implant
16182188|NCT01529879|Device|Nanotite Certain Tapered implant|Nanotite Certain Tapered (standard abutment connection) implant
16182189|NCT01529866|Device|New Abutment Connection implant|New abutment connection implant
16182190|NCT01529866|Device|Nanotite Certain Tapered implant|Nanotite certain tapered (standard abutment connection) implant
16182191|NCT01529853|Drug|SAR156597|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
16182192|NCT01529853|Drug|Placebo (for SAR156597)|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
16182193|NCT01529840|Drug|somatropin|Retrospective data collection based on data obtained from a prospective, open-label, randomised, parallel-group trial (S/GHD/004/NOO) combined with a present follow-up visit
16182194|NCT01529840|Drug|somatropin|Retrospective data collection based on data obtained from a prospective, open-label, randomised, parallel-group trial (S/GHD/004/NOO) combined with a present follow-up visit
16182195|NCT01529827|Drug|fludarabine phosphate|Given IV
16182196|NCT01529827|Drug|melphalan|Given IV
16182197|NCT01529827|Radiation|total-body irradiation|Undergo TBI
16182198|NCT01529827|Drug|tacrolimus|Given IV or PO
16182199|NCT01529827|Drug|mycophenolate mofetil|Given IV or PO
16182200|NCT01529827|Drug|methotrexate|Given IV
16182201|NCT01529827|Other|laboratory biomarker analysis|Correlative studies
16182202|NCT01529827|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo allogeneic PBSCT
16182203|NCT01529827|Procedure|peripheral blood stem cell transplantation|Undergo PBSCT
16182204|NCT01529814|Device|Implant with new abutment connection|New abutment connection implant system
16182205|NCT01529814|Device|Nanotite Certain Tapered implant|Nanotite Certain Tapered (standard abutment connection) implant
16182206|NCT01529801|Device|Osseotite Certain Tapered Group A|Osseotite Certain Tapered with different surface roughness
16182207|NCT01529801|Device|Osseotite Certain Tapered Group B|Osseotite Certain Tapered with different surface roughness
16182208|NCT01529801|Device|Osseotite Certain Tapered Group C|Osseotite Certain Tapered with different surface roughness
16182209|NCT01529788|Drug|Right lateral orbital injection of Botox Cosmetic or Dysport|Right lateral orbital injection of Botox Cosmetic or Dysport (10 units and 30 units, respectively) divided among 4 injection points (0.05 mL [7.5 units] per injection point) divided among 4 injection points (0.05mL [2.5units]) on Day 0 of the study
16182210|NCT01529788|Drug|Left lateral orbital injection of Botox Cosmetic or Dysport|Left lateral orbital injection of Botox Cosmetic or Dysport (10 units and 30 units, respectively) divided among 4 injection points (0.05 mL [7.5 units] per injection point) divided among 4 injection points (0.05mL [2.5units]) on Day 0 of the study
16182211|NCT01529775|Device|Osseotite Certain Tapered Prevail|Osseotite implant with platform switching feature
16182212|NCT01529775|Device|Osseotite Certain Tapered|Osseotite implant with non-platform switching feature
16182249|NCT01529541|Drug|Sitagliptin|Sitagliptin 100mg, tablet, once a day (QD)
16182213|NCT01529749|Drug|EFV/FTC/TDF + Losartan|EFV/FTC/TDF --> oral, 600/200/245 mg, od Losartan --> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24H in week 12.
16182214|NCT01529749|Drug|EFV/FTC/TDF|600/200/245 mg, od, oral
16182215|NCT01529749|Drug|FTC/TDF + MK-0518|FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral
16182216|NCT01529749|Drug|FTC/TDF+MK-0518+Losartan|FTC/TDF --> 200/245 mg, oral MK-0518 --> 400 mg, oral Losartan --> -> initial dose 50 mg/24h, in patients with good tolerance, dose will be increased to 100 mg/24n in week 12.
16182217|NCT01529736|Procedure|High torque insertion|Osseotite implant placed with high insertion torque forces
16182218|NCT01529736|Procedure|Low torque insertion|Osseotite implant placed with low insertion torque forces
16182219|NCT01529710|Drug|Myrrh|Subjects will be treated by Mirazid as 600 mg oral (Soft Gelatin Capsules) for 6 consecutive days or 40mg/Kg body weight of Praziquantel as a single oral dose. Subjects will be evaluated for success of treatment at 12 weeks of treatment. Evaluation will be done by examining urine or stool samples for Schistosomiasis including egg counts for the positive cases.
16182220|NCT01529697|Behavioral|Active Feedback|The inhaler will be fitted with a device that makes an audio recording of the inhaler use. This audio data will be downloaded to a computer program, analyzed for assessment of whether the steps involved in using the inhaler have been performed correctly. This information will be discussed with the patient.
16182221|NCT01529684|Drug|radio-labeled OSI-906|Part A: oral solution of 14C-OSI-906
16182222|NCT01529684|Drug|OSI-906|Part B: oral tablets OSI-906
16182223|NCT01529671|Drug|PF-05089771|PF-05089771 will be dosed as a suspension twice daily (BID)
16182224|NCT01529671|Drug|PF-05089771|PF-05089771 will be dosed as a suspension twice daily (BID)
16182225|NCT01529671|Drug|PF-05089771|PF-05089771 will be dosed as a suspension twice daily (BID)
16182226|NCT01529671|Drug|PF-05089771|PF-05089771 will be dosed as a suspension twice daily (BID)
16182227|NCT01529671|Drug|PF-05089771|PF-05089771 will be dosed as a suspension BID
16182228|NCT01529658|Procedure|Renal hypothermia|"Within 10 seconds of clamping the renal vessels, the kidney will be encased with saline ice slush for a period of 10 minutes. The slush will be created from sterile saline using an operating room slush machine. The slush is applied by the surgeon and lightly packed around the kidney to ensure complete coverage with at least a 2 cm layer. Slush removal is performed by the surgeon beginning at the 10 minute mark. Enough slush is removed to uncover the tumour area. Surgical incision of the kidney begins as soon as the tumour area is uncovered.
~When reconstruction of the kidney is complete, the slush is completely removed from the surgical field and the clamps are removed from the renal vein and artery."
16182229|NCT01529645|Biological|Acellular pertussis vaccine|Acellular pertussis (aP) vaccine was administered with different antigen doses intramuscularly in the upper deltoid region of the subject's non-dominant arm.
16182230|NCT01529645|Biological|Tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed)|Tetanus, reduced diphtheria, and acellular pertussis (TdaP) vaccine was administered with different antigen doses intramuscularly in the upper deltoid region of the subject's non-dominant arm.
16182231|NCT01529645|Biological|Licensed TdaP booster vaccine|Licenced TdaP booster vaccine was administered intramuscularly in the upper deltoid region of the subject's non-dominant arm.
16182232|NCT01529645|Biological|Diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany)|To ensure all subjects receive a tetanus and diphtheria booster vaccination, an injection was administered on Study Day 30, one month after the administration of the investigational vaccine.
16182233|NCT01529645|Other|Saline solution|Subjects received one injection of saline solution at one month after vaccination.
16182234|NCT01529632|Drug|QVA149|QVA149 110/50 ug supplied as capsules in blister packs for inhalation via SDDPI, once daily
16182235|NCT01529632|Drug|NVA237|NVA237 50 ug supplied as capsules in blister packs for inhalation via SDDPI, once daily
16182236|NCT01529632|Drug|QAB149|QAB149 150 ug supplied as capsules in blister packs for inhalation via SDDPI , once daily
16182237|NCT01529632|Drug|Placebo|Placebo capsules provided in blister packs for inhalation via SDDPI, once daily
16182238|NCT01529619|Drug|Rivastigmine transdermal patch|
16182239|NCT01529606|Other|Composite restoration and tooth cleaning|Standard preventive treatment will be repeated on semi-annual (6-month) recall visits. All composite restorations will be placed according to the manufacturer's instruction.
16182240|NCT01529606|Procedure|Plasma treatment|plasma treatment after preparation and for caries prevention
16182241|NCT01529593|Drug|Temsirolimus|"Starting dose: 25 mg by vein weekly.
~Expansion cohort: Once MTD is determined, or at maximum tolerated dose level explored (Level 5) if MTD is not reached, additional 14 patients enrolled."
16182242|NCT01529593|Drug|Metformin|"Starting dose: 500 mg titrated over first 3 weeks.
~Expansion cohort: Once MTD is determined, or at maximum tolerated dose level explored (Level 5) if MTD is not reached, additional 14 patients enrolled"
16182243|NCT01529580|Behavioral|Non-Verbal School Aged Children with Autism (NVSACA) Intervention|"The intervention has 3 components:
~One-on-one play based intervention: administered by the interventionist at the school for 1 hour, three times a week, each week for the 5 month duration of the intervention.
~Parent training: at the beginning of the 5th month of intervention, parents will receive training once a week for an hour during the remaining four weeks of intervention.
~Teacher training: in month 2 of the intervention, the teacher will receive 2 1.5 hour training sessions along with a weekly in-class coaching given as needed following completion of the second session of training."
16182244|NCT01529567|Behavioral|Cognitive Behavioral Therapy without exposure|10 week internet-delivered cognitive behavioral therapy, including mindfulness training, education about the negative effects of excessive avoidance and control behaviors on IBS symptoms and quality of life, and guided behavioral change aiming to increase quality of life and flexibility.
16182245|NCT01529567|Behavioral|Cognitive Behavioral Therapy with exposure|10 week internet-delivered cognitive behavioral therapy, including mindfulness training, education about the negative effects of excessive avoidance and control behaviors on IBS symptoms and quality of life, guided behavioral change aiming to increase quality of life and flexibility, and systematic exposure to IBS symptoms and aversive situations.
16182246|NCT01529554|Drug|Everolimus|(d0=7.5 mg, d1=7.5 mg. d2=7.5 mg, d3=5 mg, d4=5mg)
16182247|NCT01529554|Drug|Placebo|matched placebo tablets manufactured to be identical to verum tablets except content of everolimus
16182253|NCT01529515|Drug|PP3M 175 mg eq.|Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
16182254|NCT01529515|Drug|PP3M 263 mg eq.|Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
16182255|NCT01529515|Drug|PP3M 350 mg eq.|Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
16182256|NCT01529515|Drug|PP3M 525 mg eq.|Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
16182257|NCT01529515|Drug|Placebo (20% Intralipid emulsion)|Form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
16182258|NCT01529502|Procedure|Red blood Cells auto-transfusion|Withdrawal from 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 3 days storage time. The same 14 subjects will be included in every arm of the study.
16182259|NCT01529502|Procedure|Red blood Cells auto-transfusion|Withdrawal from the same 14 overweight volunteers of one unit of red blood cells and auto-transfusion after 40 days storage time.
16182260|NCT01529502|Drug|Inhaled Nitric Oxide (iNO) administration|Subjects will breath iNO (80ppm) for 10 minutes before, during and for one hour after the autologous old-blood transfusion.
16182261|NCT01529489|Other|Resisted/Aerobic physical training|COPD, aerobic physical training in cicloergometer, resisted physical training in cicloergometer, oxygen uptake kinetic, heart rate kinetic.
16182262|NCT01529489|Other|Interval physical training in elliptical equipament|Control group (healthy individuals), interval physical training, elliptical equipment, oxygen uptake kinetic, heart rate kinetic.
16182263|NCT01529489|Other|Interval physical training in elliptical equipament|COPD, interval physical training, elliptical equipament, oxygen uptake kinetic, heart rate kinetic
16182264|NCT01529489|Other|Resisted/Aerobic physical training|Control group, aerobic physical training in cicloergometer, resisted physical training in leg-press oxygen uptake kinetic heart rate kinetic
16182265|NCT01529476|Drug|Levofloxacin|levofloxacin 500 mg,QD,7~10 days
16182266|NCT01529476|Drug|Nemonoxacin|Nemonoxacin 500mg,QD,7~10 days
16182267|NCT01529450|Drug|LDE225|800-mg (4 200-mg capsules/day) capsule
16182268|NCT01529437|Drug|sublingual immunotherapy|Sublingual immunotherapy is provided in an extract form under IND 13485 and dosed safely through a maintenance dose of 12 months.
16182269|NCT01529437|Drug|placebo sublingual immunotherapy|SLIT placebo will be the same color and consistency of the active drug arm to provide double blinding
16182270|NCT01529424|Drug|ISIS apoC-III Rx|Dose 1
16182271|NCT01529424|Drug|ISIS apoC-III Rx|Dose 2
16182272|NCT01529424|Drug|ISIS apoC-III Rx|Dose 3
16182273|NCT01529424|Drug|Placebo|Dose 1
16182274|NCT01529424|Drug|Placebo|Dose 2
16182275|NCT01529424|Drug|Placebo|Dose 3
16182276|NCT01529411|Drug|Vinflunine|Vinflunine 320 mg/m2 IV infusion in 20 minutes every 21 days (280mg/m2 if PS=1, age ≥ 75 years, previous pelvic radiotherapy or creatinine clearance < 60ml/min).
16182277|NCT01529411|Other|Undefined (standard care)|All the current interventions used by each institution for the study disease.
16182278|NCT01529398|Other|Sensorimotor training (SMT)|The group realized 16 weeks of sensorimotor training, twice a week, with duration of 30 minutes each session. The intervention included agility and coordination exercises, perturbation training and stretching exercises. Also, the participants received orientation about the knee osteoarthritis.
16182279|NCT01529398|Other|Resistance training (RT)|The group realized 16 weeks of resistance training for the quadriceps and hamstring muscles, twice a week, with duration of 30 minutes each session. The intervention included strength leg raises, simple quadriceps and hamstring strengthening with cuff weights realized in 3 sets of ten repetition maximum(10RM) for each muscle group. The group also realized stretching exercises for lower limbs and received orientation about the knee osteoarthritis.
16182280|NCT01529398|Other|Control group (CG)|Patients in this group also received information about knee osteoarthritis and realized the same warm-up and cool-down intervention realized in the interventional groups. During 16 weeks they went to the ambulatory twice a week to perform 5 minutes of stationary bicycle and 5 minutes of stretching exercises for lower limbs.
16182281|NCT01529385|Device|mild compression diabetic sock|A diabetic sock that provides mild compression (18-25mm Hg) is to be worn everyday for four weeks
16182282|NCT01529385|Device|Standard diabetic sock|A diabetic sock that is not designed to provide compression is to be worn everyday for four weeks
16182283|NCT01529372|Device|PARADISE percutaneous renal denervation|Intravascular ultrasound emission
16182284|NCT01529359|Dietary Supplement|Lactibiane Tolerance|Probiotics combination 2 gelules per days during 6 weeks
16182285|NCT01529359|Dietary Supplement|Placebo|Placebo 2 gelules per days for 6 weeks
16182286|NCT01529346|Drug|PF-05089771|A single dose of PF-05089771 1600 mg oral solution administered once to the subject on Day 1 postoperatively
16182287|NCT01529346|Other|Placebo|Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively
16182288|NCT01529346|Drug|PF-05089771|A single dose of PF-05089771 450 mg oral solution administered once to the subject on Day 1 postoperatively
16182289|NCT01529346|Other|Placebo|Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively
16182290|NCT01529346|Drug|PF-05089771|A single dose of PF-05089771 150 mg oral solution administered once to the subject on Day 1 postoperatively
16182291|NCT01529346|Other|Placebo|Placebo tablets for ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively
16182292|NCT01529346|Drug|Ibuprofen|2 X 200 mg tablets of ibuprofen administered orally once to the subject on Day 1 postoperatively
16182293|NCT01529346|Other|Placebo|Placebo solution for PF-05089771: A single dose of Placebo solution administered once to the subject on Day 1 postoperatively
16182294|NCT01529346|Other|Placebo|Placebo solution for PF-05089771:A single dose of Placebo solution administered once to the subject on Day 1 postoperatively
16182295|NCT01529346|Other|Placebo|Placebo tablets for Ibuprofen: 2 X 200 mg placebo tablets administered orally once to the subject on Day 1 postoperatively
16182296|NCT01529333|Device|Middle Ear Implant with MET V Transducer|The MET V System is indicated for use in addressing the amplification needs of adults, 18 years of age and older, who have mixed hearing loss.
16182297|NCT01529320|Drug|Adventan® (methylprednisolone aceponate 0,1%)|Doses: 1/4 FTU (Finger Tip Unit) during 5 days (Day 7-Day 11). Procedure: Patch Test (Nickel sulphate 5%) during 2 days (Day 0- Day 2.
16182298|NCT01529307|Drug|TAS266|TAS266 IV infusions given weekly
16182299|NCT01529294|Drug|Iloperidone|
16182300|NCT01529281|Dietary Supplement|Branch Chain Amino Acid (BCAA)|Supplementation lasted for a total of 12 days; this was based on previous research showing a positive with BCAA supplementation on markers of muscle damage. Participants ingested 10 g, twice per day (morning and evening) of BCAA . The BCAA supplement contained a ratio of 2:1:1 (leucine, isoleucine and valine, respectively). The BCAA was in powder form where each serving was mixed with ~300 ml of water.
16182301|NCT01529281|Dietary Supplement|Placebo - asparmate|Supplementation lasted for a total of 12 days. Participants ingested an equivalent looking volume to 10 g of BCAA, twice per day (morning and evening) of placebo (aspartame based artificial sweetener). The BCAA supplement contained a ratio of 2:1:1 (leucine, isoleucine and valine, respectively). The artificial sweetener was in powder form where each serving was mixed with ~300 ml of water.
16182302|NCT01529268|Drug|DR cysteamine bitartrate capsule|"600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline
~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline
~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
16182303|NCT01529268|Other|DR cysteamine bitartrate placebo|"600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline
~750 mg/day (five 75 mg capsules twice daily) for patients >65 - 80 kg at baseline
~900 mg/day (six 75 mg capsules twice daily) for patients >80 kg at baseline"
16182304|NCT01529255|Drug|telbivudine (ROADMAP)|"Patients will receive oral telbivudine 600mg, daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily
~Stopping rules:
~The participants who achieve HBeAg seroconversion and HBV DNA<300copies/ml with over 12 months consolidation treatment in EFFORT study will discontinue treatment.
~The participants who don't meet the rules above will continue their previous treatment and follow up at the interval of 12 weeks until they finish the 156 weeks therapy or achieve the stopping rules.
~Follow up： The participants who stopped treatment will follow up at the interval of 12 weeks for 52 weeks. Of these patients, if they have confirmed virologic relapse during follow-up period, they will be excluded from the trial."
16182305|NCT01529255|Drug|Telbivudine (Standard of Care)|"Patients will receive oral telbivudine 600mg, daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily
~Stopping rules:
~The participants who achieve HBeAg seroconversion and HBV DNA<300copies/ml with over 12 months consolidation treatment in EFFORT study will discontinue treatment.
~The participants who don't meet the rules above will continue their previous treatment and follow up at the interval of 12 weeks until they finish the 156 weeks therapy or achieve the stopping rules.
~Follow up： The participants who stopped treatment will follow up at the interval of 12 weeks for 52 weeks. Of these patients, if they have confirmed virologic relapse during follow-up period, they will be excluded from the trial."
16182306|NCT01529242|Drug|Desloratadine + Prednisolone|Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day
16182307|NCT01529242|Drug|Dexchlorpheniramine + Betamethasone|Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day
16182308|NCT01529229|Drug|Dexchlorpheniramine + Betamethasone|Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day
16182309|NCT01529229|Drug|Desloratadine + Prednisolone|Children (2 to 5 years): 2.5 ml 3 times a day Children (6 to 12 years): 5.0 ml 3 times a day
16182310|NCT01529216|Device|DIAMOND System|Electrical stimulation to the fundus
16182311|NCT01529203|Drug|Botulinum Toxin Type A (Azzalure)|Powder for solution for injection
16182312|NCT01529203|Device|Restylane ranges|Hyaluronic acid (HA) 20 mg/mL + Lidocaine 0.3% (Restylane® Lidocaine, Restylane® Perlane™ Lidocaine, Restylane® SubQ Lidocaine, Restylane® Lip Volume, Restylane® Lip Refresh)
16182313|NCT01529190|Drug|Pregabalin|Effect of Preoperative Pregabalin on Pain Intensity. 300mg of pregabalin before surgical incision
16182314|NCT01529190|Drug|Placebo|placebo
16182315|NCT01529177|Drug|Metformin / clomid / hCG|Metformin 1000 mg daily for a week then twice daily for 2 weeks then 3 tomes daily for 6 months.
16182316|NCT01529177|Drug|Clomiphene citrate / hCG|Clomiphene citrate 50 mg daily for one month, then twice daily for 2 months then 3 times per day for 3 months.
16182317|NCT01529164|Drug|Endostatins (Endostar)|7.5mg/m2 iv d1-10,repeat every 14 days,until progression or occurrence of untolerated toxicity
16182318|NCT01529164|Drug|Oxaliplatin|85mg/m2 iv d1 ,repeat every 14 days,until progression or occurrence of untolerated toxicity
16182319|NCT01529164|Drug|Leucovorin|200mg/m2 iv d1 ,repeat every 14 days
16182320|NCT01529164|Drug|5-fluorouracil|400mg/m2 iv bolus,then 2400mg/m2 continuous infusion for 46 hours,repeated every 14 days,until progression or occurrence of untolerated toxicity
16182321|NCT01529151|Other|Osteopathic Manipulative Treatment (OMT)|Direct action OMT procedures, including HVLA, involve the application of a force in the direction of restricted joint motion in order to resolve somatic dysfunction. Indirect techniques, including counterstrain, balanced ligamentous tension and myofascial release, entail applying a force away from the restrictive barrier of a joint or soft tissue structure.
16182322|NCT01529151|Other|Vestibular Rehabilitation Therapy (VRT)|Participants categorized as having a peripheral motion hypersensitivity will receive habituation exercises that reproduce the provocative motion, seated and standing balance exercises with gaze stabilization, kinesthetic and proprioceptive retraining. Participants will be given a monthly exercise log at onset and will be asked to report exercise levels at subsequent follow up periods.
16182323|NCT01529138|Drug|Axitinib|Combination treatment with temsirolimus and axitinib
16182324|NCT01529138|Drug|Temsirolimus|Combination treatment with temsirolimus and axitinib
16182325|NCT01529125|Drug|zidovudine, lamivudine, nevirapine|
16182326|NCT01529112|Drug|Lenvatinib|
16182327|NCT01529112|Drug|Lenvatinib matched placebo|
16182328|NCT01529112|Drug|BSC|
16182329|NCT01529099|Device|SIGMA HP PARTIAL KNEE|SIGMA HP PARTIAL KNEE
16182330|NCT01529073|Drug|Nitazoxanide|Nitazoxanide 500 mg bid po for 4 weeks, followed by nitazoxanide 500 mg bid plus pegylated interferon alpha 2b 1.5 mg/kg/week sc plus weight-adjusted ribavirin po for 48 weeks.
16182331|NCT01529060|Drug|Phenylbutyrate|Dosage of phenylbutyrate powder will be 500 mg/kg/day in patients weighing less than 20kg and 10 g/m2/day in larger patients in four divided doses per day, the standard UCD dose studied in our preliminary studies, for 14 days.
16182332|NCT01529060|Drug|Placebo powder|Dosage of inactive placebo powder will be 500 mg/kg/day in patients weighing less than 20kg and 10 g/m2/day in larger patients in four divided doses per day for 14 days. Subjects will receive the same amount of powder for each arm of the study.
16182333|NCT01529047|Behavioral|Personalized Feedback Intervention|Printed or electronic form containing personalized information about health-relevant behaviors
16182334|NCT01529034|Drug|USL261|
16182335|NCT01529008|Drug|Core decompression/PREOB® implantation|All patients will undergo a core decompression under general anesthesia combined with the implantation of PREOB® into the necrotic lesion (single administration).
16182336|NCT01529008|Drug|Core decompression/placebo implantation|All patients will undergo a core decompression under general anesthesia combined with the implantation of placebo into the necrotic lesion (single administration).
16182337|NCT01528995|Device|Medtronic Interstim II-3058|impulse generator
16182338|NCT01528995|Procedure|Anal bulking injection|"Permacol injection:
~four submucosal injections are administered at the 12, 3, 6 and 9 o'clock positions, above the level of the dentate line. The injection produces a bulge in the mucosa"
16182339|NCT01528982|Behavioral|Mindfulness|Subjects receive mindfulness training
16182340|NCT01528982|Behavioral|Cognition|Subject receive cognitive training
16182341|NCT01528969|Dietary Supplement|xylitol|Subjects will chew 2 pieces of xylitol chewing gum (1,5 g/pellet) three times a day in the experimental group for a five-week period.
16182342|NCT01528969|Dietary Supplement|sorbitol|Subjects will chew 2 pieces of sorbitol chewing gum (1,5 g/pellet) three times a day in the control group for a five-week period.
16182343|NCT01528956|Genetic|DNA methylation analysis|
16182344|NCT01528956|Genetic|RNA analysis|
16182345|NCT01528956|Genetic|gene expression analysis|
16182346|NCT01528956|Genetic|nucleic acid sequencing|
16182347|NCT01528956|Genetic|polymorphism analysis|
16182348|NCT01528943|Drug|Prostacycline|Continuous infusion peri -and 6 hours postoperatively of prostacycline 1 ng/kg/min
16182349|NCT01528943|Drug|Isotonic saline|same volume as the group that are allocated to prostacycline
16182350|NCT01528930|Drug|Amikacin|500 mg, once daily for 2 years
16182351|NCT01528891|Drug|Dexmedetomidine|0.5 micrograms/Kilogram one time bolus 5 minutes prior to the end of surgery
16182352|NCT01528891|Other|Placebo|
16182353|NCT01528878|Radiation|Stereotactic Radiosurgery using the CyberKnife System.|"Radiation: Stereotactic Radiosurgery using the CyberKnife System. The CyberKnife system has been cleared by the U.S. Food and Drug Administration (FDA) to treat lesions, tumors and conditions, anywhere in the body when radiation treatment is indicated. To address movement of target lesion during the respiratory cycle, the Synchrony™ option will be used.
~The Synchrony option precisely tracks tumors in or near the target organ as they move, enabling the highly focused beams of radiation to destroy the tumors with minimal injury to adjacent normal tissue. The Synchrony option records the breathing movements of a patient's chest and combines that information with sequential x-ray pictures of tiny markers inserted inside or in the proximity of the tumor to enable precise delivery of radiation during any point in the respiration cycle. The CyberKnife system with the Synchrony option enables reduced normal tissue exposure by using smaller treatment margins and increased accuracy."
16182354|NCT01528865|Drug|Lamivudine|"Creatinine Clearance (mL/min): ≥50, Recommended Dosage of Epivir: 150 mg twice daily or 300 mg once daily.
~Creatinine Clearance (mL/min): 30-49, Recommended Dosage of Epivir: 150 mg once daily.
~Subjects will be taking drug for 16 weeks."
16182355|NCT01528865|Drug|Tenofovir disoproxil fumarate|300 mg once a day p.o. for 16 weeks.
16182356|NCT01528852|Drug|Chlorhexidine 4%|4% liquid solution used for cord cleaning once daily for 10 days
16182357|NCT01528852|Drug|Chlorhexidine 4%|Chlorhexidine 4% liquid solution used for cord cleaning once daily for 10 days
16182358|NCT01528852|Other|Control cord cleaning solution|Mild soapy solution used to clean cord once daily for 10 days
16182359|NCT01528839|Drug|L-Thyroxine|L-Thyroxine as addon to ongoing stable antidepressant and /or mood stabilizing therapy: week 1: 100 mcg; week 2: 200 mcg: week 3 to week 6: 300 mcg
16182360|NCT01528839|Drug|Placebo|
16182361|NCT01528826|Drug|vinorelbine plus oxaliplatin|Vinorelbine 30mg/m2 IVGTT D1 Oxaliplatin 90mg/m2 IVGTT D1; every 2 weeks
16182362|NCT01528813|Device|Er:YAG laser + amorolfine lacquer|To each compromised ungual unit randomly assigned to this group it will be applied a single session of Er:YAG laser to the ungual lamina in the beginning of study. Onwards, amorolfine lacquer will be applied weekly for a period of 06 months.
16182363|NCT01528813|Drug|Amorolfine lacquer|To each compromised ungual unit randomly assigned to this group, it will be applied amorolfine lacquer weekly for a period of 06 months.
16182364|NCT01528800|Drug|Vitamin K1|10mg orally three times a week for 12 months
16182365|NCT01528800|Drug|Microcrystalline Methylcellulose|10mg orally three times a week for 12 months
16182366|NCT01528787|Drug|AR-13324 Ophthalmic Solution 0.01%|Administered to study eye, once daily (QD) in the morning (AM) for 7 days
16182367|NCT01528787|Drug|AR-13324 Ophthalmic Solution 0.02%|Administered to study eye, QD AM for 7 days
16182368|NCT01528787|Drug|AR-13324 Ophthalmic Solution 0.04%|Administered to study eye, QD AM for 7 days
16182369|NCT01528787|Other|AR-13324 Ophthalmic Solution Vehicle|Administered to study eye, QD AM for 7 days
16182370|NCT01528774|Other|Blood Draw|Approximately 40 cc of blood will be drawn from participants at a time when they are having blood drawn for routine or treatment-related purposes. Sequential samples may be obtained in the same manner from selected patients to allow exploration of potential correlation of CTC with response to treatment, progression-free survival and overall survival.
16182397|NCT01528618|Drug|gemcitabine and cisplatin|The GP regimen consists of gemcitabine at a dose of 1,000 mg/m2 by intravenous (i.v.) infusion over 30 min on day 1 and day 8, and cisplatin 80 mg/m2 by i.v. infusion for 4 h on day 1 only
16190741|NCT01466257|Genetic|mutation analysis|
16182371|NCT01528761|Behavioral|Prosocial Behavior Physical Activity (PBPA)|The PBPA condition involves a cognitive-behavioral intervention to teach participants the behavioral skills to engage in independent physical activity. Participants will engage in supervised physical activity delivered two times a week during months 1 to 3 at the William G. White, Jr. Family YMCA in Winston-Salem, NC. During months 4 to 6, supervised sessions will be held once per week, and sessions will be held once per month in months 7 to 9. Participants will engage in completely independent physical activity in months 10 to 12. PBPA participants will also be able to earn boxes of food for donation to the Second Harvest Food Bank (SHFB) of Northwest North Carolina based upon their weekly physical activity. Lowe's Foods, a regional grocery chain, will donate the food. Participants in the PBPA intervention also will receive a 12-month membership to the William G. White, Jr. Family YMCA at no cost.
16182372|NCT01528761|Other|Healthy Aging (HA)|The HA group will receive a health education intervention based on topics from several sources, including the National Institute on Aging's Age Pages, University of Pittsburgh's 10 Keys to Healthy Aging; and Stanford University's Successful Aging program, among other topics . The HA intervention will receive ongoing staff contact, and will provide participants with excellent information on health-related topics. Biweekly 45-minute lectures will be given during months 1 to 6, and once per month during months 7 to 9. After each session, participants will engage in a 15-minute stretching routine. During months 10 to 12, no lectures will be given. After completion of the 12-month assessments, participants will receive a 12-month membership to the YMCA at no cost.
16182373|NCT01528748|Behavioral|Cognitive Behavioral Analysis System of Psychotherapy|Cognitive Behavioral Analysis System of Psychotherapy (CBASP) is a behavioral intervention that addresses the unique behavioral characteristics of chronically depressed individuals, most of which are highly relevant for alcoholics as well. CBASP has a structured, individualized, and collaborative (patient and clinician) design. The intervention emphasizes teaching effective coping strategies and employing motivational, cognitive, behavioral, and interpersonal techniques. Individual therapy (1 hour) sessions occur on a weekly basis for a total of 20 sessions over a period of 21 weeks.
16182374|NCT01528735|Drug|BI 207127 NA|one fix dose
16182375|NCT01528735|Drug|peginterferon|per package insert
16182376|NCT01528735|Drug|Ribavirin|per weight BID
16182377|NCT01528735|Drug|Ribavirin|per weight BID
16182378|NCT01528735|Drug|BI 207127 NA|one fix dose
16182379|NCT01528735|Drug|BI 201335 NA|high dose
16182380|NCT01528735|Drug|BI 201335 NA|low dose
16182381|NCT01528735|Drug|peginterferon|per package insert
16182382|NCT01528722|Drug|Bupivacaine|0.25% 20ml administered intraperitoneal
16182383|NCT01528722|Other|Normal saline|sodium chloride 0.9% solution
16182384|NCT01528709|Drug|Atorvastatin 80 mg daily|Atorvastatin 80 mg daily for 1 year
16182385|NCT01528709|Drug|Atorvastatin 10 mg daily|Atorvastatin 10 mg daily for 1 year
16182386|NCT01528696|Device|Silverlon|"Patients will be randomized to either receive a silver dressing. Patients who receive a silver dressing will have that dressing replaced on postoperative day number 2. This will be left in place until the patient is seen for follow up by the visiting nurse.
~All patient will be evaluated by the visiting nurse on postoperative day 4 or 5 and have their wounds photographed. All patients will be contacted for a brief survey 6 weeks postpartum."
16182387|NCT01528696|Device|Standard Dressing|Standard island dressing. Patients who receive a standard dressing will have that dressing removed on postoperative day 2. This will be left in place until the patient is seen for follow up by the visiting nurse.
16182388|NCT01528683|Radiation|Carbon Ion Radiotherapy|Treatment with carbon ion radiotherapy using the rasterscanning technique
16182389|NCT01528657|Other|Ventricular Pace Suppression (Vps)|Unnecessary ventricular pacing is avoided by promoting intrinsic conduction. In case of intrinsic conduction, the device switches from a DDD mode to an ADI mode.
16182390|NCT01528657|Other|Intrinsic rhythm support (IRSplus)|All parameters of the AV hysteresis functions are set in a way to maintain spontaneous AV conduction of the patient's heart as long as possible.
16182391|NCT01528644|Dietary Supplement|alginate beads containing ferrous gluconate|After insertion of the cannula and collection of baseline blood sample a single dose of approximately 20mg of iron as ferrous gluconate incorporated into alginate beads (approximately 22.2g)and added to cola jelly (200ml) will be given to the volunteer together with 3 placebo capsules (each containing 50mg of dextrose)and cola drink (200ml). Once consumed, further blood samples will be taken at specified time points during 6 hour cannulation time. A minimum of 7 days wash out period will take place prior next intervention.
16182392|NCT01528644|Dietary Supplement|ferrous gluconate in a capsule|After insertion of the cannula and collection of baseline blood sample a single dose of approximately 20mg of iron as ferrous gluconate in a capsule and 2 placebo capsules (each containing 50mg of dextrose) followed by a cola jelly (200ml)and cola drink (200ml) will be given to the volunteer. Once consumed, further blood samples will be taken at specified time points during 6 hour cannulation time. A minimum of 7 days wash out period will take place prior next intervention.
16182393|NCT01528644|Dietary Supplement|ferrous gluconate in a capsule in presence of calcium|After insertion of the cannula and collection of baseline blood sample a single dose of approximately 20mg of iron as ferrous gluconate in a capsule together with 2 calcium capsules (each containing 300mg of calcium phosphate)followed by cola jelly (200ml) and cola drink(200ml)will be given to the volunteer . Once consumed, further blood samples will be taken at specified time points during 6 hour cannulation time. A minimum of 7 days wash out period will take place prior next intervention.
16182394|NCT01528644|Dietary Supplement|alginate beads with ferrous gluconate in presence of calcium|After insertion of the cannula and collection of baseline blood sample a single dose of approximately 20mg of iron as ferrous gluconate incorporated into alginate beads (approximately 22.2g)and added to cola jelly (200ml) will be given to the volunteer together with 2 calcium capsules (each containing 300mg of calcium as calcium phosphate, 1 placebo capsule (containing 50mg of dextrose)and cola drink (200ml). Once consumed, further blood samples will be taken at specified time points during 6 hour cannulation time. A minimum of 7 days wash out period will take place prior next intervention.
16182395|NCT01528631|Other|D-Fagomine|30 mg (initial dose), with 50 grams of sucrose in 200 ml of water.
16182396|NCT01528631|Other|D-Fagomine|0 mg (control) blended with 50 grams of sucrose in 200 ml of water.
16182461|NCT01528163|Drug|Methotrexate|From 40 mg/m2 (first cycle) to 50 mg/m2. Intravenous injections every three weeks.
16182398|NCT01528618|Drug|5-Fluorouracil and cisplatin|The FP regimen consists of 5-Fluorouracil 1,000 mg/m2/day which was administered as a continuous intravenous infusion for 96 hours after completion of the cisplatin on days 1( 80 mg/m2 i.v. infusion for 4 h)
16182399|NCT01528605|Dietary Supplement|placebo|Placebo, one gelatine capsule containing starch per day, for 96 weeks
16182400|NCT01528605|Dietary Supplement|low lutein|one gelatine capsule containing 10mg lutein per day, for 96 weeks
16182401|NCT01528605|Dietary Supplement|high lutein|one gelatine capsule containing 20mg lutein per day, for 96 weeks
16182402|NCT01528605|Dietary Supplement|lutein plus zeaxanthin|one gelatine capsule containing 10mg lutein and 10mg zeaxanthin per day, for 96 weeks
16182403|NCT01528605|Dietary Supplement|high zeaxanthin|one gelatine capsule containing 10mg zeaxanthin per day, for 48 weeks
16182404|NCT01528605|Dietary Supplement|zeaxanthin plus lutein|one gelatine capsule containing 10 mg lutein and 15 mg zeaxanthin per day, for 48 weeks
16182405|NCT01528592|Drug|Carbidopa-Levodopa|Equivalent amount of carbidopa-levodopa will be provide to you
16182406|NCT01528579|Other|Neck Specific Exercises|2 times a week for 3 months followed by encourages to continue on their own
16182407|NCT01528579|Behavioral|Behavioral approach combined with neck specific exercises|Behavioral physiotherapeutic approach combined with neck specific exercises 2 times a week for 3 months. Exercises will be chosen from a well defined and structured frame of exercises.
16182408|NCT01528579|Other|Prescribed Physical activity|Physical activity without neck specific exercises for 3 months
16182409|NCT01528566|Behavioral|Tai Chi|The experimental group received three sessions of Sun Tai Chi (TC) a week for 20 weeks (20-to-40 minute exercise plus a 5-minute rest per session). Sun TC includes 6 basic and 6 advanced forms designed for all ages with arthritis seeking a joint-safe exercise routine.
16182410|NCT01528566|Behavioral|Attention control|The attention control group participated in health education, culture related activities and other activities for a total of 20 weeks. The attention control protocol was standardized in terms of teaching content, materials and duration. The length and frequency of the activities carried out in this group closely matched those in the TC group.
16182411|NCT01528553|Device|8plate|12 mm or 16 mm plate. 24 mm or 36 mm screw
16182412|NCT01528553|Device|Staples (Richards, Smith & Nephew)|Staples (3 on each side)
16182413|NCT01528540|Drug|Placebo|This group will include placebo.
16182414|NCT01528540|Drug|Antioxidant plus Pregabalin|This group will contain combination of antioxidant cocktail and pregabalin
16182415|NCT01528514|Dietary Supplement|Curcuminoids|Curcuminoids in capsule form, 4 capsules four times daily (4 grams/day)
16182416|NCT01528514|Other|Placebo|Placebo in capsule form, 4 capsules 4 times/day
16182417|NCT01528501|Drug|Panobinostat (LBH589)|
16182418|NCT01528488|Other|EVOZAC Calming Skin Spray|EVOZAC Calming Skin Spray should be sprayed to the skin in the total face, three times per day
16182419|NCT01528488|Other|Physiological saline|Physiological saline was used as the placebo of EVOZAC® Calming Skin Spray and should be also sprayed on the total face, three times per day
16182420|NCT01528475|Behavioral|Pre-hospital cooling|Patients in this arm will receive pre-hospital cooling by paramedics. This treatment includes placement of surface ice-pacs on the neck, groin, and axillae; midazolam to prevent shivering; initiation of an intravenous infusion of cold saline; and wrist and ankle bands with text to remind in-hospital clinicians to continue therapeutic hypothermia.
16182421|NCT01528462|Other|Expedited Treatment of Sleep Disorders|Patients in this arm will undergo an expedited polysomnogram (if clinically necessary) and early treatment of any sleep disorders. Sleep-related disorders will be managed with the currently recommended therapies; patients with obstructive sleep apnea will be treated with positional therapy, continuous positive airway pressure (CPAP), etc., and those with restless legs syndrome will be treated with standard treatments such as iron, or dopaminergic agonists. Patients will also be counselled on improving their sleep hygiene and adjusting the timing of their medication administration to optimize efficacy. Furthermore, patients will receive information handouts.
16182422|NCT01528449|Biological|B.microti diagnostic blood tests|the interventions/procedures are investigational diagnostic tests for B.microti (PCR and IFA).
16182423|NCT01528449|Biological|B.microti diagnostic blood tests|the interventions/procedures are investigational diagnostic tests for B.microti (PCR and IFA).
16182424|NCT01528436|Biological|Umbilical Cord Blood Infusion|The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression.
16182425|NCT01528436|Other|Placebo Umbilical Cord Blood|Placebo Umbilical Cord Blood that resembles cord blood in appearance was designed.
16182426|NCT01528436|Other|Active Rehabilitation|All subjects should participate in active rehabilitation. They will receive two physical and occupational therapy sessions per day. Post discharge, each participant should continue to receive rehabilitation therapy at least 3 days per week until the study completion.
16182427|NCT01528423|Procedure|XtremeCT|The scanning protocol for each subject will be as follows: Non-dominant, non-fractured distal radius x 2 with repositioning between scans Non-dominant, non-fractured distal tibia x 2 with repositioning between scans using XtremeCT device and Non-dominant forearm x 2 with repositioning between scans Non-dominant lower leg x 2 with repositioning between scans using standard pQCT device
16182428|NCT01528410|Device|ALFApump removal of ascites|Implanted ALFApump, removing produced ascites according to programmed schedule
16182429|NCT01528410|Procedure|Large volume paracentesis for removal of ascites|Large volume paracentesis - standard of care, removing ascites according to patient need
16182430|NCT01528397|Procedure|pedicled nerve graft|A pedicled nerve graft harvested from the dorsal branch of the PDN can be used for reconstruction of such defects. The graft is based on the second dorsal metacarpal artery.
16182431|NCT01528384|Drug|ADI-PEG 20|4.5, 9 and 18 mg/m2 dosage weekly dosing intramuscular until progressive disease
16182462|NCT01528137|Biological|talactoferrin|Given PO
16182463|NCT01528137|Other|laboratory biomarker analysis|Correlative studies
16182464|NCT01528124|Drug|LY3025876|Given as a subcutaneous injection
16182465|NCT01528124|Drug|Placebo|Given as a subcutaneous injection
16182466|NCT01528111|Drug|LX7101 (0.125%)|Subjects will receive 0.125% LX7101
16182467|NCT01528111|Drug|LX7101 (0.25%)|Subjects will receive 0.25% LX7101
16182432|NCT01528371|Drug|Midazolam|"Investigators select subject from patients for whom the doctor has ordered intravenous sedation. Inclusion criteria is SBP>=140mmHg or DBP>=90mmHg measuring when the patient sits on dental chair and has settled down for 5 minutes. Informed consent is obtained from the patient.
~Patient conducts Japanese version of STAI and VAS about anxiety to dental treatment.
~Investigators take venous line on the upper limb and inject the drug (midazolam at dose of 0.02mg/kg) intravenously. Investigators measure blood pressure, heart rate, and oxygen saturation every 2 minutes until 10 minutes after drug administration.
~10 minutes later, patient conducts Japanese version of STAI and VAS about anxiety to dental procedure again.
~Investigators inject an additional sedative agent and the dental treatment is started."
16182433|NCT01528371|Drug|Normal Saline Solution (NSS)|"Investigators select subject from patients for whom the doctor has ordered intravenous sedation. Inclusion criteria is SBP>=140mmHg or DBP>=90mmHg measuring when the patient sits on dental chair and has settled down for 5 minutes. Informed consent is obtained from the patient.
~Patient conducts Japanese version of STAI and VAS about anxiety to dental treatment.
~Investigators take venous line on the upper limb and inject the drug (saline solution at dose of 0.004ml/kg) intravenously. Investigators measure blood pressure, heart rate, and oxygen saturation every 2 minutes until 10 minutes after drug administration.
~10 minutes later, patient conducts Japanese version of STAI and VAS about anxiety to dental procedure again.
~Investigators inject an additional sedative agent and the dental treatment is started."
16182434|NCT01528345|Drug|Dovitinib|Active Dovitinib (in tablet form) taken orally at a dose of 500 mg (i.e., 5 x 100mg tablets) on a 5 days on/2 days off dosing schedule
16182435|NCT01528345|Drug|Fulvestrant|Fulvestrant (in solution) injected intramuscularly at a dose of 500 mg once on Week 1 Day 1, Week 3 Day 1 and Week 5 Day 1 and subsequently once every 4 weeks on Day 1 of the week.
16182436|NCT01528345|Drug|Dovitinib Placebo|Dovitinib Placebo (in tablet form) taken orally at a dose of 500 mg (i.e., 5 x 100mg tablets) on a 5 days on/2 days off dosing schedule
16182437|NCT01528332|Device|Pain Relief Patch|The Pain Relief Patch is a non CE-marked device that is worn on the painful area of the back, where it shines light (453 ± 7 nm, maximum 42 ± 6 mW/cm2 and average 20 ± 1 mW/cm²). It will be used 5 times over 14 days for 30 minutes each time.
16182438|NCT01528332|Device|Control PRP device|The Control PRP device is also a non CE-marked device. It is similar in appearance to the active Pain Relief Patch, except that it shines light of a different wavelength(531 ± 7 nm, maximum 0.4 ± 0.1 mW/cm² and average 0.2 ± 0.05 mW/cm²) for just 5 seconds before it turns off. Participants in the control arm will be treated with the control PRP device 5 times over 14 days for 30 minutes each time.
16182439|NCT01528319|Device|MG-1|Being embedded in the area of glenohumeral instability by arthroscopic Bankart repair method.
16182440|NCT01528306|Biological|HP802-247|"Wounds up to 12 cm2: 1 spray each component (0.5 x 106 cells per mL allogeneic human keratinocytes and fibroblasts) applied weekly as a topical spray for up to 4 weeks in each of 2 treatment periods
~Larger wounds:
~(>12 cm2 and ≤ 24 cm2) 2 sprays each; (>24 cm2 and ≤ 36 cm2) 3 sprays each; (>36 cm2 and ≤ 48 cm2) 4 sprays each"
16182441|NCT01528306|Other|Placebo|"Wounds up to 12 cm2: 1 spray each component (thrombin solution and fibrinogen solution) applied weekly as a topical spray for up to 4 weeks in each of 2 treatment periods
~Larger wounds:
~(>12 cm2 and ≤ 24 cm2) 2 sprays each; (>24 cm2 and ≤ 36 cm2) 3 sprays each; (>36 cm2 and ≤ 48 cm2) 4 sprays each"
16182442|NCT01528293|Device|ActiVAC System|The ActiV.A.C. System will be applied in a customary manner per manufacturer's recommendations. Acticoat Flex 7™ will be applied as contact layer on the wound surface. Open cell foam is then applied over the top of the Acticoat Flex 7™. Adherent transparent occlusive material will be applied over the open cell foam. The tubing is then attached after cutting a small aperture through the occlusive material. Negative pressure will be set at 125mmHg on continuous suction. Sponge and canister will be replaced 2 time a week.
16182443|NCT01528293|Other|Compression therapy|Compression Therapy Profore™ multi-layered compression bandaging system will be utilized. This includes the application of a contact layer dressing using Acticoat Flex 7™. The compression bandage will be applied per manufacturer's recommendations.
16182444|NCT01528280|Biological|Vaccination against hepatitis A|Vaccination against hepatitis A (2 doses) into the deltoid muscle of the nondominant arm twice, i.e., at 0 and 6 months.
16182445|NCT01528280|Other|No Intervention|No Intervention
16182446|NCT01528267|Other|Autologous blood|50mls of autologous blood injected into each of 3 bronchopulmonary segments.
16182447|NCT01528267|Other|Normal saline|50mls of normal saline injected into each of 3 bronchopulmonary segments.
16182448|NCT01528254|Drug|Placebo of vildagliptin|
16182449|NCT01528254|Drug|vildagliptin|One tablet (50 mg oral) of vildagliptin in the morning and one tablet in the evening with or without food.
16182450|NCT01528254|Drug|Metformin|Twice daily (bid) regimen during or after meals at the same time as vildagliptin.
16182451|NCT01528241|Drug|ABP688|Carbon 11 labeled ABP688 will be administered intravenously as a slow intravenous push.
16182452|NCT01528228|Device|TENS Treatment with functional or disabled unit|TENS treatment will be standardized and will consist of 20 minute sessions three times per day at the manufacturer's recommended settings for both functional and disabled TENS units.
16182453|NCT01528215|Device|OsseoSpeed EV|OsseoSpeed EV implants; Ø 3.6, 4.2, 4.8 mm in lengths of 9,11 and 13 mm
16182454|NCT01528215|Device|OsseoSpeed TX|OsseoSpeed TX implants; Ø 3.5, 4.0 and 5.0 mm in lengths of 9,11 and 13 mm
16182455|NCT01528202|Dietary Supplement|Cherry juice|30 mLs preceding morning meal and 30 mLs preceding evening meal each day for 7 days.
16182456|NCT01528202|Dietary Supplement|Fruit juice cordial|fruit flavoured juice concentrate
16182457|NCT01528189|Other|Hyperinsulinemic normoglycemic clamp|Patients will receive an IV infusion of 2 mU/kg/min (0.12 U/kg/hour) starting in the operating room. Dextrose 20% will be titrated to maintain blood glucose between 4 and 6 mmol/l. At the end of surgery, the insulin infusion will be stopped and the dextrose infusion weaned off in the postanesthesia care unit.
16182458|NCT01528189|Other|Standard glucose management|Blood glucose levels will be treated by a standard insulin sliding scale.
16182459|NCT01528176|Drug|10,000 IU of cholecalciferol for a total of 8 weeks|Subjects were treated with weekly oral administration of 10,000 IU of cholecalciferol for a total of 8 weeks in order to correct the vitamin D deficiency.
16182460|NCT01528163|Drug|Cabazitaxel|from 20 mg/m2 to 25 mg/m2. Intravenous injection every three weeks.
16182469|NCT01528085|Drug|Nilotinib|Nilotinib, p.o Chemotherapy (Dexamethasone, Methotroxate, Cyclophosphamide (optional), Vincristine, Vindesine, Cytarabine, 6-Mercapto-Purine)
16182470|NCT01528072|Device|Dynesys Spinal System|Dynesys Spinal System will be used for all subjects
16182471|NCT01528059|Procedure|Stomach-small intestine reconstruction|Billroth II or Roux en Y reconstruction will be performed after gastric resection in stomach patients co-morbid with type 2 diabetes
16182472|NCT01528046|Drug|Vincristine|Vincristine (VCR) = 1.5 mg/m^2/day (maximum dose 2 mg), days 1 and 8, administered as intravenous (IV) bolus over 1-5 minutes
16182473|NCT01528046|Drug|Irinotecan|Irinotecan (IRN) = 50 mg/m^2/day, days 1-5, IV over 60 minutes
16182474|NCT01528046|Drug|Temozolomide|Temozolomide (TEM) = 50 mg/m^2/day by mouth (PO) Days 1-5
16182475|NCT01528046|Drug|Metformin|Metformin (MET) = dose as per dose escalation, divided twice a day (BID), PO continuously for the 21 day cycle.
16182476|NCT01528033|Device|Vacuum Assisted Closure®|"Vacuum Assisted Closure® (V.A.C.®) Therapy within a maximum study treatment time of 42 days.
~VAC® Therapy Systems used within the trial are ActiV.A.C.®, InfoV.A.C.®, V.A.C. Freedom®, V.A.C. Via® and VAC Ulta®. All used systems are equally eligible for the treatment of subcutaneous abdominal wounds and should be used according to availability and local preferences within the trial site.
~Systems differ regarding user surface and display and processing of data. For the treatment of subcutaneous abdominal wounds the V.A.C.® Granufoam Dressing (size medium and big) is recommended."
16182477|NCT01528033|Other|Standard conventional wound therapy|Standard conventional wound therapy (SCWT) according to institutional clinical standards within a maximum study treatment time of 42 days
16182478|NCT01528020|Behavioral|Dialectical Behavior Therapy|DBT is a cognitive behavioral approach to treatment that synthesizes change based strategies characteristic of behavior therapy and validation strategies consistent with acceptance based treatments through application of dialectical principles and techniques. Based on a combined capability deficit and motivational model which states that 1) adolescents with suicidal behaviors and borderline features lack important interpersonal, self-regulation and distress tolerance skills, and 2) personal and environmental factors often both block and/or inhibit use of behavioral skills that adolescents do have, and at times reinforce dysfunctional behaviors. The primary adaptation for adolescents is the inclusion of family in the DBT skills training portion of therapy as well as a much greater inclusion of parents in the management of high suicide risk.
16182479|NCT01528020|Behavioral|Individual and Group Supportive Therapy|The aim of IGST is relief or reduction of symptoms, the promotion of personal growth including enhancement of adolescents' strengths/coping skills and capacity to use environmental supports and to help suicidal adolescents increase their sense of self-esteem. Treatment aims to reduce suicidal behavior and emotion dysregulation by helping the adolescent learn to trust and validate themselves. The overarching assumption in IGST is that adolescents become suicidal for a variety of reasons, but they often report feeling isolated, misunderstood, unloved and unwanted. IGST Interventions include providing a strong therapeutic alliance where the therapist provides an environment that is completely trusting and validating to counter the experience of the depressed/suicidal youth.
16182480|NCT01528007|Drug|Naltrexone pharmacotherapy|Naltrexone 50mg when graving to gamble.
16182481|NCT01528007|Drug|Placebo|Placebo pill with no active ingredients.
16182482|NCT01527994|Drug|Aprepitant|Aprepitant 125 mg oral tablets
16182483|NCT01527994|Drug|Placebo pill|Placebo oral pill- inactive compound
16182484|NCT01527981|Behavioral|Cognitive behavioral therapy for adherence and depression|Cognitive-behavioral therapy for adherence and depression (CBT-AD) is a weekly, psychosocial treatment focusing on depression and patients' adherence to diabetes self-care. Treatment consists of weekly one-hour sessions for approximately 10 sessions.
16182485|NCT01527968|Drug|Tranexamic Acid|TXA as 10mg/kg x 1 dose in 100mL normal saline over 15 minutes prior to the procedure then an infusion of 1mg/kg/hr during the procedure + placebo (normal saline as the dummy for eACA.)
16182486|NCT01527968|Drug|Epsilon Aminocaproic Acid|eACA as 150mg/kg in 250mL of IV normal saline over 15 minutes prior to the procedure then an infusion of 15mg/kg/hr during the procedure + placebo (normal saline as the dummy for TXA).
16182487|NCT01527968|Drug|Normal Saline|Control Normal Saline x 2 infusions as the double dummy for TXA and eACA.
16182488|NCT01527955|Other|Kelee Meditation|The participants were instructed on how to perform Kelee Meditation (KM) at the initial session. This was followed by a comprehensive review of the Kelee principles and reference points over the subsequent 12 weeks. At the beginning of each weekly session, a group meditation was performed, which was followed by individual introspection and contemplation. Participants recorded their observations and experiences in a KM journal. Each participant had the opportunity to share his own journal entry and to ask questions about his own observations and experiences since starting KM. Participants were encouraged to perform the KM practice 10 minutes twice daily throughout the 12 weeks of the study.
16182489|NCT01527942|Drug|Acetaminophen|Intravenous Acetaminophen 1,000 mg IV
16182490|NCT01527942|Drug|Placebo|Placebo - IV administration 0.9% 100 ml Sodium Chloride (NaCl)
16182491|NCT01527929|Drug|Cabazitaxel XRP6258|Pharmaceutical form: solution for infusion Route of administration: intravenous
16182492|NCT01527916|Drug|placebo|Placebo Comparator
16182493|NCT01527916|Drug|donepezil|Active Comparator
16182494|NCT01527916|Drug|ABT-126|low dose, middle dose, high dose
16182495|NCT01527903|Drug|Propofol infusion|IV propofol 2% at a rate of 1.0 mg kg-1 h-1, increments or decrements of 0.1 mg kg-1 h-1
16182496|NCT01527903|Drug|Midazolam infusion|midazolam at a rate of 0.1 mg kg-1 h-1, increments or decrements of 0.05 mg kg-1 h-1
16182497|NCT01527890|Drug|Fentanyl|intravenous patient-controlled analgesia
16182498|NCT01527877|Drug|BKM120|"Patients will be instructed to take BKM120 orally at a dose of 100 mg with a glass of water once daily, in a fasting state or with a light fat-free meal, and as close as possible to the same time each day. The patient will be dosed on a flat scale of mg/day and not be adjusted to body weight or body surface area. If vomiting occurs no attempt should be made to replace the dose.
~• BKM120 should be taken 1-hour following a light meal. Please note that patients must avoid consumption of Seville orange (and juice), grapefruit or grapefruit juice, grapefruit hybrids, pummelos and exotic citrus fruits from 7 days prior to the first dose of study drug and during the entire study treatment period due to potential CYP3A4 interaction. Regular orange juice is allowed."
16182499|NCT01527864|Drug|pegylated endostatin and Paclitaxel-Carboplatin|Dosage：10mg/m2
16182502|NCT01527825|Biological|Trivalent influenza vaccine (seasonal)|"Single 0.5ml dose of Southern hemisphere 2012 TIV, formulation containing:
~An A/California/7/2009 (H1N1)pdm-like virus
~An A/Perth/16/2009 (H3N2)-like virus*
~A B/Brisbane/60/2008-like virus * A/Wisconsin/15/2009 and A/Victoria/210/2009 are A/Perth/16/2009-like viruses for use in the 2012 Southern Hemisphere winter. This vaccine is the same as the vaccine used for the 2011 Southern hemisphere influenza season."
16182503|NCT01527825|Biological|Normal saline|0.5ml normal saline will be used as 'placebo' vaccine to maintain blinding
16182504|NCT01527812|Procedure|Femoral nerve block|We will perform an ultrasound guided femoral nerve block. For locating the nerve a 5 cm, 6-13 MHz linear probe (Sonosite Turbo M, Bothwell WA, USA) will be used. After the examination of the anatomy of the femoral artery we will fix the probe transversal to the thigh below the inguinal crease and above the ramification of deep femoral artery and make skin marks on this position. A 22 G 50 mm long Stimuplex BBraun needle will be used. 15 ml 2 % lignocaine will be injected.
16182505|NCT01527786|Drug|Desvenlafaxine|50mg-100mg everyday for 12 weeks over 7 study visits
16182506|NCT01527760|Drug|Viscum album ethanolic extract manufactured according to Homoeopathic pharmacopoeia of India (H.P.I.)|Ten drops of Drug in 30 ml of distilled water with a frequency of three times a day for a duration of 12 weeks
16182507|NCT01527747|Drug|Saxagliptin|5 mg daily
16182508|NCT01527734|Drug|Tetrodotoxin|15ug and 30ug once or twice a day for 1 or 2 days.
16182509|NCT01527734|Drug|placebo|1ml once or twice a day for 1 or 2 days.
16182510|NCT01527721|Procedure|Corneal Collagen Cross-Linking (CxL)|The same surgical procedure was applied to all keratoconus patients that included: Instillation of proparacaine hydrochloride 0.5% drops for topical anaesthesia, application of a sponge saturated with 10% alcohol to the central cornea for 30 seconds and subsequent de-epithelialization by means of a hockey knife. Following de-epithelialization, a mixture of 0.1% riboflavin in 20% Dextran solution was instilled to the cornea for 30 minutes (2 drops every 2 minutes) prior to the irradiation, until the stroma was completely penetrated and aqueous was stained yellow. The UVA radiation source was UV-XTM Zurich, . Instillation of riboflavin drops (1 drop every 2 minutes) was continued during irradiation, as well, in order to sustain the necessary concentration of the riboflavin. Moreover, balanced salt solution (BSS) was applied every 6 minutes to moisten the cornea.
16182511|NCT01527721|Procedure|Corneal Collagen Cross-Linking combined with t-PRK|For tCxL group, the topo-guided PRK preceded the CXL. The epithelium was mechanically removed with a hockey knife and ablation was performed in a 9.0 mm zone with a maximal intended ablation depth of 50μm. No adjuvant Mitomycin-C was applied in any case. For the photorefractive ablation we used the Allegretto Wave 200 Hz (1.0071-1-0.81/1.208 software/ WaveLight AG, Erlangen, Germany) with the T-CAT ablation profile.
16182512|NCT01527708|Procedure|Corneal Collagen Cross-linking (CXL)|Instillation of proparacaine hydrochloride 0.5% drops for topical anaesthesia, application of a sponge saturated with 10% alcohol to the central cornea for 20-30 seconds and subsequent de-epithelialization by means of a hockey knife. Following de-epithelialization, a mixture of 0.1% riboflavin in 20% Dextran solution was instilled to the cornea for 30 minutes (2 drops every 2 minutes) prior to the irradiation. In details, an 8.0mm diameter of central cornea was irradiated for 30 minutes by UVA light with a wavelength of 370nm and an irradiance of 3mW/cm2.The UVA radiation source that was used is the UV-XTM (IROC AG, Zurich, Switzerland). Instillation of riboflavin drops (1 drop every 2 minutes) was continued during irradiation, as well.
16182513|NCT01527695|Drug|ER tablet 25 mg AZD3241|2 tablets twice daily for Day 1
16182514|NCT01527695|Drug|ER tablet 100 mg AZD3241|1-6 tablets twice daily from Day 2 until Day 56±3 days
16182515|NCT01527695|Drug|Placebo for AZD3241 25 mg|2 tablets twice daily for Day 1
16182516|NCT01527695|Drug|Placebo for AZD3241 100 mg|1-6 tablets twice daily from Day 2 until Day 56±3 days
16182517|NCT01527682|Drug|Latanoprost, Dorzolamide|"Latanoprost 0.005% ophthalmic solution given once a day at nighttime (9.00 PM)
~Dorzolamide 2% ophthalmic solution given three times a day as a monotherapy, two times a day if in combination with latanoprost"
16182518|NCT01527669|Drug|LipoCol Forte capsules|The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects.
16182519|NCT01527669|Drug|Lovastatin Tablet|The pharmacokinetic study of red yeast rice capsule compared to lovastatin tablet in healthy subjects.
16182520|NCT01527656|Drug|biphasic insulin aspart 70|A single dose administrated subcutaneously (s.c., under the skin) on two separate dosing visits. A wash-out period of 6-12 days will take place between dosing visits
16182521|NCT01527643|Drug|biphasic insulin aspart 50|A single dose administrated subcutaneously (s.c., under the skin) on two separate dosing visits. A wash-out period of 6-12 days will take place between dosing visits
16182522|NCT01527630|Drug|biphasic insulin aspart 50|A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-21days
16182523|NCT01527617|Other|Cranberry|beverage containing cranberry at a dose of 15.2 ounces per day for 56 days.
16182524|NCT01527617|Other|Non-Cranberry beverage|Placebo Comparator - beverage absent cranberry at a dose of 15.2 ounces per day for 56 days.
16182525|NCT01527604|Other|Avenanthramide-enriched oats|avenanthramide-enriched oats, delivered as muffins at a dose of 2 muffins per day for 56 days.
16182526|NCT01527604|Other|Refined flour absent avenanthramides|refined flour absent avenanthramides, delivered as muffins at a dose of 2 muffins per day for 56 days.
16182527|NCT01527591|Biological|Pneumococcal Conjugate Vaccine 13 (PCV13)|A single intramuscular dose of 0.5 mL.
16182528|NCT01527565|Drug|biphasic insulin aspart 70|A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-12 days
16182529|NCT01527552|Drug|biphasic insulin aspart 50|A single dose of each formulation administered subcutaneously (s.c., under the skin) on 2 dosing visits separated by a wash-out period of 6-12 days
16182530|NCT01527539|Drug|biphasic insulin aspart 30|Dose individually adjusted. Injected twice daily immediately before breakfast and dinner. Administrated subcutaneously (s.c., under the skin)
16182531|NCT01527513|Drug|Eslicarbazepine acetate (BIA 2-093)|Eslicarbazepine acetate (ESL) tablets 200 mg and the matching placebo will be supplied. Treatments will be administered by oral route, once-daily, in the evening. The dose will be rounded to the nearest 100 mg unit. Half tablets may be used for dose adjustment if necessary.
16182532|NCT01527513|Drug|Placebo|Treatments will be administered by oral route, once-daily, in the evening.
16182534|NCT01527500|Drug|Sham|Sham injection (akin to intravitreal injection but without intravitreal needle; no investigational drug given)
16182535|NCT01527500|Drug|LFG316 Lower dose|LFG316 5 mg/50 μL solution for IVT Injection
16182536|NCT01527487|Drug|Eribulin|1.4 mg/m2 IV (Days 1 & 8), given short (≤15 minute) IV infusion, per institutional standard
16182537|NCT01527487|Drug|Cyclophosphamide|Cyclophosphamide will be given as an IV infusion (600 mg/m2) on Day 1 of each treatment cycle over approximately 30 minutes, or per institutional standard.
16182538|NCT01527487|Drug|Docetaxel|Patients assigned to Treatment Arm 2 will receive docetaxel 75 mg/m2 IV on Day 1 of each treatment cycle every 3 weeks.
16182539|NCT01527474|Drug|escitalopram|participants will be initiated at a dose of 10mg/day which will be adjusted by the study clinician based on the presences of depressive symptoms and side effects up to a maximum of 20mg/day.
16182540|NCT01527448|Drug|Quetiapine XR (seroquel)|During the study period, subjects will be receiving a treatment with Quetiapine XR. The starting dose of quetiapine that subjects will receive is 50mg. The response to the treatment of quetiapine will determine whether the study doctor will increase the dosage of the subject's quetiapine. If the study doctor increases the quetiapine during the study, the maximum dosage allowable during the study is 300mg.
16182541|NCT01527422|Drug|Cyclophosphamide, Doxorubicin, Vincristine and Prednisone|Rituximab will be administered on day 1 of courses 1-6 at 375 mg/m2 concurrently with CHOP-R.All patients will receive antiemetics priorchemotherapy.Courses will be repeated every 14 days.If blood counts don't allow re-treatment on day 14 the counts will be repeated at least twice per week until recovery allows re-treatment.The aim is to achieve a dose that will be as close as possible to 250 mcg and that will result in grade 0 or grade 1A or 1B toxicity at the most. The dose of PEG-Filgrastim will initially be fixed at 3 mg until dose level +3 is reached (which includes 250 mcg Leukine) at which time the dose of Neulasta will be escalated if necessary. All patients will receive Neulasta as a subcutaneous injection on the day 3.
16182542|NCT01527409|Behavioral|Tailored health partnership program|"When intervention group participate in the tailored program, they can receive various information which is related with three strategic areas (exercise, diet, and posttraumatic growth).
~Three areas are based on the transtheoretical model (TTM), social cognitive theory, PRECEDE-PROCEED model, and Health behavior model.
~Patients will be received tailored manual and workbook for health tele-coaching that help them to lead their healthy life.
~The health tele-coaching will be operated sixteen times for 24 weeks. Intervention group will be provided three contents (exercise, diet, and posttraumatic growth) from health partners. The health partners took a certificate that is related with health, leadership and coaching.
~Also, patients will be provided a workshop for leadership that is dealt with controlling their healthy life. It will be proceeded for four hours. Three hours is for the leadership, and the last one hour is for presentation of their health mission statement."
16182543|NCT01527409|Behavioral|Usual care and health education workshop|"While intervention group participate in the tailored health partnership program, control group can receive various information which is related with ten contents for health management (smoke and drinking, diet, exercise, posttraumatic growth, distress, pain, comorbidity, sleep disturbance, pain, and energy conservation). They will be provided a workshop and booklet for a health education for four hours.
~Twelve month later, they will be provided the tailored health partnership program which is especially dealing with exercise, diet, and posttraumatic growth as same as the intervention group."
16182544|NCT01527383|Biological|V212|V212 viral antigen for HZ
16182545|NCT01527383|Biological|Placebo|Placebo comparator to V212 vaccine
16182546|NCT01527370|Biological|Zoster Vaccine Live|One approximately 0.65 mL injection subcutaneously on Day 1
16182547|NCT01527357|Biological|Fibrocaps|Human fibrinogen and thrombin powder, for topical administration.
16182548|NCT01527357|Biological|Gelatin sponge|Absorbable gelatin sponge for topical administration.
16182549|NCT01527331|Behavioral|video decision aid|cpr video decision aid
16182550|NCT01527318|Drug|Fibrate treatment|Patients will receive a dosage of 400mg Bezafibrate every day during 28 weeks
16182551|NCT01527305|Drug|Paliperidone palmitate|Participants will receive 1 intramuscular (into muscle) injection of 150 milligram (mg) on Day 1 and 1 injection of 100 mg on Day 8. Participants will also receive the last 2 paliperidone intramuscular injections between 50 - 150 mg (based on effectiveness and safety profile), on Day 36 and Day 64.
16182552|NCT01527292|Radiation|Stereotactic Radiation Therapy|SRT only
16182553|NCT01527292|Radiation|SRT with Vertebral Augmentation Procedure|SRT with VAP
16182554|NCT01527279|Drug|antazoline|Patients assigned to antazoline group will be administered antazoline in boluses of 50mg diluted to 10cm3 every 5 minutes up to cumulative dose of 250mg or conversion of AF to SN. Drug administration will also be stopped in case of serious adverse event or conversion of AF to different supraventricular arrhythmia. BP will be measured before every injection.
16182555|NCT01527279|Drug|0.9% saline|Patients assigned to control group will be administered 0.9% saline in boluses of 10cm3 every 5 minutes up to cumulative volume of 50cm3, conversion of AF to SN or in case of serious adverse event or conversion of AF to different supraventricular arrhythmia. BP will be measured before every injection.
16182556|NCT01527266|Dietary Supplement|Carbohydrate drink|sucrose beverage
16182557|NCT01527266|Dietary Supplement|Placebo mouth rinse|placebo; non-caloric sweetened beverage for use as a mouth rinse
16182558|NCT01527253|Other|Synergistic food basket|A low glycemic index diet enriched in dried legumes and wholegrain cereals is compared with a control regime lacking these functional ingredients for their ability to ameliorate different markers associated with the risk for developing cardiometabolic disease
16182559|NCT01527240|Drug|Ciclosprin A|The dose in this study was 2 mg / kg, administered within 15 min after beginning of thrombolysis. The treatment of the study consists of a single bolus injection. This dose was chosen according to the results of tolerance in myocardial infarction and unknown pharmacodynamic and safety data
16182560|NCT01527240|Drug|Injectable Saline Solution.|Saline Solution is administered once 15 min after thrombolysis.
16182561|NCT01527227|Other|questionnaires|The research will examine effects of personal, familial, societal and intergenerational characteristics on parentification, the effects of parentification on the quality of life of the child and what encourages a better quality of life.
16182608|NCT01526928|Drug|Rociletinib|Phase 1: Rociletinib <900 mg BID FB will be administered in escalating dosages in a period of 21-day cycles
16190742|NCT01466257|Other|laboratory biomarker analysis|
16182562|NCT01527214|Radiation|CT scan and education|GPs get direct access to chest CT scans for their patients. The GPs will be offered special training related to the diagnosis of lung cancer in general practice.This will be done by offering training sessions and written material. The training will include risk groups, alarm symptoms, symptom complexes and interpretation of CT scan descriptions.
16182563|NCT01527201|Procedure|Arthroscopic debridement|Surgeon will debride, or remove, worn out cartilage.
16182564|NCT01527188|Biological|100IR|100IR sublingual tablet of
16182565|NCT01527188|Biological|300IR|300IR sublingual tablets of
16182566|NCT01527188|Biological|500IR|500IR sublingual tablet of
16182567|NCT01527188|Other|Placebo|Placebo sublingual tablet of
16182568|NCT01527175|Other|Approach for ultrasound-guided subclavian venous catheterization|Each SCV catheterization was performed under ultrasound-guidance with supraclvicular or infraclavicular approach.
16182569|NCT01527162|Device|SAFO worn|Child wears their prescribed SAFO for 14 days by random assignment
16182570|NCT01527162|Other|SAFO not worn|Child does not wear their prescirbed SAFO for 14 days by random assignment
16182571|NCT01527149|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo autologous HDC-ASCT
16182572|NCT01527149|Drug|Cyclophosphamide|Given IV
16182573|NCT01527149|Drug|Cytarabine|Given IV
16182574|NCT01527149|Drug|Dexamethasone|Given IV or PO
16182575|NCT01527149|Drug|Doxorubicin Hydrochloride|Given IV
16182576|NCT01527149|Other|Laboratory Biomarker Analysis|Correlative studies
16182577|NCT01527149|Drug|Methotrexate|Given IV
16182578|NCT01527149|Biological|Ofatumumab|Given IV
16182579|NCT01527149|Drug|Vincristine Sulfate|Given IV
16182580|NCT01527136|Drug|entolimod|Given IM or SC
16182581|NCT01527136|Other|pharmacological study|Correlative studies
16182582|NCT01527136|Other|laboratory biomarker analysis|Correlative studies
16182583|NCT01527123|Drug|GSK2585823|CLDM1%/BPO3%
16182584|NCT01527110|Drug|Intravenous (IV) zanamivir|Zanamivir aqueous solution 10mg/mL, 600mg of IV zanamivir infusion twice daily for 5 days
16182585|NCT01527097|Drug|Atorvastatin|Drug: Atorvastatin 80 mg for 6 months following by 40 mg for additional 6 months once daily.
16182586|NCT01527097|Drug|Atorvastatin placebo|Atorvastatin 80mg during 6 month and 40mg in additional 6 month period once daily.
16182587|NCT01527084|Procedure|surgical intervention after percutaneous catheter drainage|Patients who are not improving by day 10 after PCD insertion will be included in the present study and are randomized to group A (early surgery i.e. between 10-15days after PCD insertion ) or group B (Extended treatment with PCD with saline irrigation for more than 15days after PCD insertion)
16182588|NCT01527058|Drug|68Ga-BNOTA-PRGD2|"Cancer patients, single intravenous bolus injection of nearly 111 MBq 68Ga-NOTA-PRGD2 on day one of the treatment period, dynamic whole-body PET/CT for determination of effective dose, kinetics of 68Ga-BNOTA-PRGD2 in blood, organs, and tumors
~Healthy volunteers, single intravenous bolus injection of nearly 111 MBq 68Ga-BNOTA-PRGD2 on day one of the treatment period, dynamic whole-body PET/CT for determination of effective dose, kinetics of 68Ga-BNOTA-PRGD2 in blood and organs"
16182589|NCT01527045|Drug|Atorvastatin Calcium|Given PO
16182590|NCT01527045|Drug|Cyclosporine|Given PO
16182591|NCT01527045|Drug|Fludarabine Phosphate|Given IV
16182592|NCT01527045|Other|Laboratory Biomarker Analysis|Correlative studies
16182593|NCT01527045|Drug|Mycophenolate Mofetil|Given PO or IV
16182594|NCT01527045|Procedure|Nonmyeloablative Allogeneic Hematopoietic Stem Cell Transplantation|Undergo nonmyeloablative allogeneic PBSC transplant
16182595|NCT01527045|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo nonmyeloablative allogeneic PBSC transplant
16182596|NCT01527045|Radiation|Total-Body Irradiation|Undergo TBI
16182597|NCT01527032|Drug|melphalan, thalidomide and dexamethasone|
16182598|NCT01527019|Drug|Norfloxacin|Norfloxacin Pills, 400 mg twice daily. Treatment time will range according to sex and age (male and elderly subjects will receive 7 days of treatment, while female subjects who are 18-59 years old will receive 3 days of treatment)
16182599|NCT01527019|Drug|Cephalosporins|Cephalosporins Caps, 400 mg once daily. Treatment time will range according to sex and age (male and elderly subjects will receive 7 days of treatment, while female subjects who are 18-59 years old will receive 3 days of treatment)
16182600|NCT01527019|Drug|Cephalosporins|Cephalosporins Oral Suspension, 400 mg once daily. Treatment time will range according to sex and age (male and elderly subjects will receive 7 days of treatment, while female subjects who are 18-59 years old will receive 3 days of treatment)
16182601|NCT01527006|Drug|perampanel|During the titration period, participants started at a set daily dose of 0.015 mg/kg and had doses up-titrated at 1-week intervals (6 titration steps) to a maximum daily dose of 0.18 mg/kg. During the Maintenance Period, participants continued taking perampanel oral suspension once daily at the dose level they achieved at the end of the Titration Period. During the extension phase, participants continued taking perampanel oral suspension once daily, at the dose level achieved at the end of the treatment phase of the core study to a maximum daily dose of 0.18 mg/kg. The maximum total daily dose a participant was allowed was 12 mg.
16182602|NCT01526980|Drug|biphasic insulin aspart 30|Administrated subcutaneously (s.c., under the skin) once daily before dinner for 30 days in each treatment period
16182603|NCT01526980|Drug|biphasic insulin aspart 70|Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and lunch for 30 days in each treatment period
16182604|NCT01526980|Drug|biphasic human insulin 30|Administrated subcutaneously (s.c., under the skin) twice daily before breakfast and dinner for 30 days in each treatment period
16182605|NCT01526954|Device|TissuGlu Surgical Adhesive|TissuGlu Surgical Adhesive to be used prior to closure of the large tissue flap in abdominoplasty cases.
16182606|NCT01526941|Drug|biphasic insulin aspart 30|Dose individually adjusted. Administered subcutaneously (s.c., under the skin) three times a day for 1 week in each treatment period. A wash-out period of 2-6 weeks will take place between treatment periods
16182607|NCT01526941|Drug|biphasic insulin aspart 70|Dose individually adjusted. Administered subcutaneously (s.c., under the skin) three times a day for 1 week in each treatment period. A wash-out period of 2-6 weeks will take place between treatment periods
16183100|NCT01523379|Drug|Placebo|NaCl i.v. two times a day, two days in an row
16182609|NCT01526928|Drug|Rociletinib|Phase 1: Rociletinib 900 mg BID FB will be administered in escalating dosages in a period of 21-day cycles
16182610|NCT01526928|Drug|Rociletinib|"Phase 1: Rociletinib 500 mg BID HBr will be administered in escalating dosages in a period of 21-day cycles
~Phase 2: Rociletinib 500 mg BID HBr will be administered daily"
16182611|NCT01526928|Drug|Rociletinib|"Phase 1: Rociletinib 625 mg BID HBr will be administered in escalating dosages in a period of 21-day cycles
~Phase 2: Rociletinib 625 mg BID HBr will be administered daily"
16182612|NCT01526928|Drug|Rociletinib|"Phase 1: Rociletinib 750 mg BID HBr will be administered in escalating dosages in a period of 21-day cycles
~Phase 2: Rociletinib 750 mg BID HBr will be administered daily"
16182613|NCT01526928|Drug|Rociletinib|"Phase 1: Rociletinib 1000 mg BID HBr will be administered in escalating dosages in a period of 21-day cycles
~Phase 2: Rociletinib 1000 mg BID HBr will be administered daily"
16182614|NCT01526915|Procedure|Bone curettage + PRF|Bone curettage and PRF insertion
16182615|NCT01526915|Procedure|Bone curettage alone|Bone curettage without PRF insertion
16182616|NCT01526902|Device|omafilcon A / PC 1-D MF|Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses.
16182617|NCT01526902|Device|lotrafilcon B / Air Optix MF|Subjects were randomly assigned into either the omafilcon A/PC 1-D MF lenses with +0.75D over-correction in the non-dominant eye or the lotrafilcon B/Air Optix MF lenses then crossed-over into the alternative pair of study lenses
16182618|NCT01526889|Drug|LFG316|LFG316 administered intravitreally (IVT)
16182619|NCT01526889|Drug|Conventional Therapy|Conventional Therapy administered in accordance with its prescribing info.
16182620|NCT01526876|Drug|clevidipine butyrate|intravenous infusion dose range 1.0 mg/hr - 32 mg/hr titrate to blood pressure effect duration of infusion: 6 hours
16182621|NCT01526863|Dietary Supplement|HA egg|Daily dose of HA egg or placebo for 6 months
16182622|NCT01526850|Biological|Biological: mesenchymal stem cell|Mesenchymal stem cells, 1-2×107, bone marrow injection, once a week for the first four weeks; whether to continue after four weeks depends on patients' symptoms.
16182623|NCT01526850|Drug|Cyclosporine and Glucocorticoid|Calmodulin inhibitors such as cyclosporine, combined with Glucocorticoid 0.5-1mg/kg/d ,to the end of the study.
16182624|NCT01526837|Drug|Avastin|Topical Avastin plus Collagen Sponge placed in surgical cavity after resection of recurrent brain tumor. Dosing range: 0.25 mg/ml - 25 mg/ml.
16182625|NCT01526824|Dietary Supplement|omega-3 polyunsaturated fatty acids (Lovaza)|Lovaza, 1 gram orally daily
16182626|NCT01526811|Device|Endurant Stent graft|Endurant Stent graft implantation
16182627|NCT01526798|Device|Theralite (high cut-off hemodialysis)|Hemodialysis with Theralite dialyzer alternating with standard high-flux dialyzer
16182628|NCT01526798|Device|Conventional high-flux dialyzer|
16182629|NCT01526785|Drug|Alglucosidase alfa|4000 L alglucosidase alfa administered by IV infusion at the same dose and dose regimen used for the patient's routine treatment prior to the study for 52 weeks.
16182630|NCT01526772|Procedure|Endoscopy|Transoral endoscopy versus transoral endoscopy
16182631|NCT01526759|Dietary Supplement|LM pectin (10%)|15 days 1 daily consumption of a drink with 10g pectin added
16182632|NCT01526759|Dietary Supplement|gelatin|15 days 1 daily consumption of a drink with 10g gelatin added
16182633|NCT01526746|Drug|Tasimelteon|20mg capsule, once
16182634|NCT01526746|Drug|Tasimelteon|20mg, once
16182635|NCT01526733|Drug|Sham Injection|
16182636|NCT01526733|Drug|Recombinant human hyaluronidase PH20|
16182637|NCT01526733|Drug|Insulin aspart|
16182638|NCT01526733|Drug|Insulin lispro|
16182639|NCT01526707|Drug|inhaled steroid|inhaled budesonide for 7 days
16182640|NCT01526694|Drug|Bendamustine|Bifunctional alkylating agent consisting of a purine and amino acid antagonist (a benzimidazole ring) and an alkylating nitrogen mustard moiety.
16182641|NCT01526694|Drug|Thalidomide|Thalidomide can directly inhibit the growth and survival of myeloma cells, by oxidative damage to DNA mediated by free radicals. The drug can induce apoptosis even in drug resistant myeloma cells. Thalidomide modulates cell adhesion molecule expression, so it may interfere with the mutually stimulatory interactions between myeloma cells and the bone marrow microenvironment.
16182642|NCT01526694|Drug|Dexamethasone|It's a corticosteroid.
16182643|NCT01526681|Other|Processed Human Nerve Graft|Implantation of appropriate length of processed human nerve graft at the time of surgery
16182644|NCT01526681|Other|Standard Treatment, Autogenous Nerve Graft, Direct Suture, etc.|Historical control from established literature
16182645|NCT01526681|Other|Autogenous Nerve Graft|Nerve gap reconstructions with autogenous nerve graft within the upper extremity
16182646|NCT01526681|Device|Nerve Tube Conduit|Nerve gap reconstructions with nerve tube conduit within the upper extremity
16182647|NCT01526681|Procedure|Autologous Breast Reconstruction with Neurotization|
16182648|NCT01526681|Procedure|Autologous Breast Reconstruction without Neurotization|
16182649|NCT01526668|Behavioral|Follow-up strategy|Comparison of different follow-up strategies
16182650|NCT01526668|Behavioral|No contact after discharge|
16182651|NCT01526655|Procedure|Abdominal total hysterectomy|Abdominal total hysterectomy through a low transverse abdominal wall incision
16182652|NCT01526655|Procedure|Robot assisted laparoscopic hysterectomy|Robot assisted laparoscopic total hysterectomy
16182653|NCT01526642|Device|Non Invasive Ventilation|NIV during night
16182654|NCT01526616|Drug|Metformin|Metformin 850 mg twice a day for six months
16182655|NCT01526616|Drug|Metformin plus Spironolactone|Metformin 850 mg twice a day for six months plus Spironolactone 25 mg day
16182656|NCT01526603|Drug|Carboplatin|Carboplatin intravenously (IV), 425 mg/m2/dose (or if ≤ 12kg, 14.2 mg/kg/dose) once daily x 4 doses on days 7 through 4 pretransplant.
16182657|NCT01526603|Biological|Autologous stem cell infusion|On day 0 the stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines.
16182694|NCT01526408|Drug|Placebo|Patients will be instructed to take 6 250mg pills orally for the first 7 days (Week 1: 2 pills every 8 hours or three times per day) at home. Patients will take a maintenance dose of one 250 mg pill twice a day for 77 days (11 weeks, total 3 months).
16182658|NCT01526603|Biological|Granulocyte colony stimulating factor|Beginning on day 0 after infusion of the PBSC, patients will receive G-CSF subcutaneously (SQ) or IV (SQ preferred) 5 micrograms/kg once daily and continuing once daily until post-nadir absolute neutrophil count (ANC) > 2000/μL for 3 consecutive days.
16182659|NCT01526603|Radiation|Radiation therapy|It is suggested that patients who have a complete surgical resection of the primary tumor receive 21.6 Gy external beam radiation therapy (EBRT) to the post-induction chemotherapy, pre-operative primary tumor volume. It is suggested that patients who have an incomplete surgical resection of the primary tumor (residual soft tissue mass measuring >1 cm3) will receive 21.6 Gy EBRT to the postinduction chemotherapy, pre-operative primary tumor volume and an additional boost of 14.4 Gy EBRT to the gross residual tumor (total dose 36 Gy to gross residual tumor volume). Radiation should be given after stem cell transplantation and should start no sooner than 28 days post transplant.
16182660|NCT01526603|Drug|Isotretinoin (13-cis-retinoic acid)|Post-transplant maintenance therapy with cis-RA daily for 14 days every 28 days repeated for 6 months. This phase of the therapy can be initiated by the BMT team and continued by the referring physician. It is recommended to begin Isotretinoin at day 66 post-transplant and no later than day 100. For patients ≤12 kg, isotretinoin (accutane) should be administered at 5.33 mg/kg/dose divided twice daily. For patients >12 kg isotretinoin (accutane) should be administered at 160 mg/m^2/day divided twice a day. Patients should be considered for monoclonal antibody therapy against GD2, such as ch14.18 if such trials are available.
16182661|NCT01526603|Drug|Melphalan|Melphalan Intravenously (IV), 70 mg/m2/dose (or if ≤ 12 kg, 2.3 mg/kg/dose) once daily x 3 doses on days 7 through 5 pretransplant
16182662|NCT01526603|Drug|Etoposide|Etoposide intravenously (IV), 338 mg/m2/dose (or if ≤ 12kg, 11.3 mg/kg/dose) once daily x 4 doses on days 7 through 4 pretransplant
16182663|NCT01526590|Drug|Definity Contrast|While the patient is still sedated from their EUS and before tissue sampling, the patient will receive a dose of Definity intravenously through their peripheral IV access after being agitated. The dose of Definity will be 10 microliters/kg given in one to two doses, and will not exceed 2cc.
16182664|NCT01526577|Drug|LC23-1306|LC23-1306 10, 30, 100, 200, 400, 600 mg Placebo 10, 30, 100, 200, 400, 600 mg
16182665|NCT01526577|Drug|placebo|LC23-1306 placebo
16182666|NCT01526577|Drug|Ticagrelor|Ticagrelor 90mg
16182667|NCT01526564|Drug|Acetylcarnitine|Administration of enteric-coated tablets with warm water at half an hour after meals, 1g (2 tablets) each time, 3 times a day, and the interval at or >4 hours for 8 weeks
16182668|NCT01526564|Drug|Placebo|3 t.i.d, two plates per time
16182669|NCT01526551|Other|HPV Vaccine and HPV-related Health Education|Increased education of HPV-related diseases and HPV vaccine
16182670|NCT01526551|Other|Reduction of barriers|Eliminate structural and financial barriers to being vaccinated
16182671|NCT01526538|Drug|d-cycloserine|50 mg d-cycloserine
16182672|NCT01526538|Drug|sugar pill|placebo
16182673|NCT01526525|Drug|Tramadol|Tramadol 1.5mg/kg bolus IV 30min before the end of the surgery and co instantaneously the CIV infusion of tramadol 0.15mg/kg/h started with continuous infusion in an adjustable flow disposable pump (paragon®)
16182674|NCT01526525|Drug|Ketamine|ketamine 10mg bolus IV 30min before the end of the surgery and co instantaneously the CIV infusion of ketamine, in subanesthetic doses, 0,15mg/kg/h started with continuous infusion in an adjustable flow disposable pump (paragon®). Ketamine's dose was altered so as not to exceed the 300mg/24h.
16182675|NCT01526525|Drug|Tramadol|If NRS scale was ≥3, PPI scale ≥2 and the algometer count ≤0,5Kg it was assumed as a non acceptable pain treatment. Tramadol 50mg IV bolus was firstly administered to the patients.The aim was that the Tramadol 24h dose would not exceed 600mg
16182676|NCT01526525|Drug|Morphine|If NRS scale was ≥3, PPI scale ≥2 and the algometer count ≤0,5Kg it was assumed as a non acceptable pain treatment. Tramadol 50mg IV bolus was firstly administered to the patients and if the NRS scale was not decreased at least about 2 points after 30 minutes, morphine 2mg IV was then administered and it could be repeated
16182677|NCT01526525|Procedure|sedation|If the patient had sedation score >2 then the analgesic infusion would be stopped, the patient would be assessed again in 1 hour and the infusion would start with the same or decreased flow.
16182678|NCT01526525|Procedure|rescue analgesia|Meanwhile - 45min,2h,6h,12h and 24h- if the patients had acute pain, the physician would call the anesthesiologist and a new assessment would take place with the relative interventions.
16182679|NCT01526525|Drug|Parecoxib|An hour before the end of the surgery all patients were administered with parecoxib 40mg (IV)
16182680|NCT01526525|Drug|paracetamol|30min before the end of the surgery paracetamol 20mg/kg (IV).
16182681|NCT01526512|Drug|metroCX|cyclophosphamide 50mg PO d1-28 capecitabine 1500mg PO d1-28; every 28days
16182682|NCT01526499|Drug|Docetaxel and Cyclophosphamide (TC)|Docetaxel 75mg/m2 IVGTT D1 Cyclophosphamide 50mg PO D1-21;every 21days
16182683|NCT01526499|Drug|Docetaxel (T)|Docetaxel 75mg/m2 IVGTT D1;every 21days
16182684|NCT01526486|Procedure|Videoscopic procedure|Minimally invasive, three port approach, (using a laparoscope to perform a procedure previously performed through open surgery).
16182685|NCT01526486|Procedure|Open, traditional approach|Open surgical procedure, with sartorius muscle transfer.
16182686|NCT01526473|Biological|AVX901|Dosing will consist of AVX901 at 4 x 10E8 IU intramuscularly, given every 2 weeks for a total of three doses.
16182687|NCT01526460|Drug|Atorvastatin|80 mg
16182688|NCT01526460|Drug|Rosuvastatin|40 mg
16182689|NCT01526460|Drug|Placebo|no statin loading dose
16182690|NCT01526447|Procedure|Craniosacral Therapy|Standardized therapy protocol (according to Upledger): Still point technique, diaphragm release, compression-decompression and lift techniques of the cranial bones, facial balancing in the region of shoulder and pelvis and somato-emotional unwinding
16182691|NCT01526447|Procedure|Sham Craniosacral Therapy|Standardized sham protocol: Placing hands on various parts of the clothed body for two minutes each time without therapeutic intention
16182692|NCT01526421|Other|monetary reinforcer|Participants randomized to the reinforcer arm will receive gift cards at the completion of screening procedures.
16182693|NCT01526408|Drug|Famciclovir|Patients will be instructed to take 6 250mg pills orally for the first 7 days (Week 1: 2 pills every 8 hours or three times per day) at home. Patients will take a maintenance dose of one 250 mg pill twice a day for 77 days (11 weeks, total 3 months on drug).
16190743|NCT01466244|Biological|cetuximab|
16182695|NCT01526395|Drug|Propofol|"The major intervention proposed in this study is the introduction of low dose IV propofol for sedation prior to ECT treatment at C.S.M Medical University. The investigators will use a dose of 0.25 to 0.50 mg/kg of IV propofol. The maximum dose of 0.50 mg/kg is not sufficient for anesthesia (i.e., to make unconscious), but should provide a light level of sedation and be amnestic, meaning the patient should have memory loss for the period of time around the ECT procedure itself. The propofol dose will be titrated upwards (from an initial dose of 0.25 mg/kg) with successive treatments in increments of 0.05mg/kg, until it is just sufficient to be lightly sedating. ECT will be administered 30 to 60 seconds after propofol is injected. ECT may be given up to three times per week."
16182696|NCT01526382|Device|PiCCO monitoring (PULSION)|Patients are monitored with PiCCO system.
16182697|NCT01526382|Procedure|central venous catheter|patients in this arm can receive central venous catheter
16182698|NCT01526369|Drug|Trastuzumab|
16182699|NCT01526369|Drug|Paclitaxel|
16182700|NCT01526369|Drug|Lapatinib|
16182701|NCT01526356|Drug|Placebo|Study cream is applied nightly to the affected areas on the face.
16182702|NCT01526356|Drug|Rapamycin|Study cream is applied nightly to the affected areas on the face. Low Dose
16182703|NCT01526356|Drug|Rapamycin|Study cream is applied nightly to the affected areas on the face. High Dose
16182704|NCT01526343|Device|Reveal XT implantation|The implantation of the Reveal XT device will be performed at the time of surgery before the planned median sternotomy or thoracotomy.
16182705|NCT01526330|Drug|YH14618|A mg/disc
16182706|NCT01526330|Drug|YH14618|B mg/disc
16182707|NCT01526330|Drug|YH14618|C mg/disc
16182708|NCT01526330|Drug|Placebo|0mg/disc
16182709|NCT01526317|Drug|Crestor 10mg(Rosuvastatin 10mg), Glucodown OR SR 750mg(Metformin SR 750mg)|For co-administration,Crestor 1 tablet and Glucodown 1 tablet a day for 5 day.(1 period) For separate administration, Crestor 1 tablet a day for 5 day and Glucodown 1 tablet a day for 5 day.
16182710|NCT01526304|Other|no intervention|No intervention, only observational study
16182711|NCT01526278|Drug|Maxmarvil®|Drug : Maxmarvil® 1tablet one time in clinical trial, PO medication
16182712|NCT01526265|Behavioral|Usual Care|Participants will receive reimbursements for completing the surveys that are part of the Way To Quit program and for submitting saliva or urine samples at 14 days, 30 days, 6 months, and 12 months (among those eligible).
16182713|NCT01526265|Behavioral|Individual Rewards|If participants quit smoking by their target quit date, and that is confirmed by cotinine/anabasine tests, they will receive a monetary award from the study investigators.
16182714|NCT01526265|Behavioral|Fixed Deposits|Participants will have to deposit a certain monetary amount of their own money as an incentive to quit smoking. If they quit smoking by their target quit date, and that is confirmed by cotinine/anabasine tests, participants will receive their deposit back. If participants do not quit, their money will be used to support future research studies designed to help people stop smoking. As a motivation to quit smoking, the participant's deposit will be matched by the study investigators in a rate of 3:1.
16182715|NCT01526265|Behavioral|Competitive Deposits (Pari-Mutuel)|"Groups (or cohorts) of 6 smokers each will be formed on a rolling basis, linking individuals with target quit dates (day 0's) near each other. Participants will deposit a certain monetary amount (Y) in an account, which will be matched on a rate of 3:1 by the study investigators (M), and the payout for quitting on this arm will be (Y+M) x 6/Q , where Q is the number of quits in the cohort. Again, success will be confirmed by cotinine or anabasine tests, and if participants do not quit, their money will be used to support future research studies designed to help people stop smoking."
16182716|NCT01526265|Behavioral|Collaborative Rewards|"Groups (or cohorts) of 6 smokers each will be formed on a rolling basis, linking individuals with target quit dates (day 0's) near each other. If participants quit smoking by their target quit date, and that is confirmed by cotinine or anabasine tests, they will receive a monetary award from the study investigators. On top of that, participants will receive an additional monetary amount for each member of their group who also quits smoking. These participants will interact through a chat room, which will help motivate them to quit smoking."
16182717|NCT01526239|Other|Colorectal cancer screening pamphlet|Colorectal cancer screening pamphlet
16182718|NCT01526226|Device|Respiratory support HFNC|In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP
16182719|NCT01526226|Device|Respiratory support NCPAP|In the cross over study 2 types of respiratory support are compared; HFNC versus nCPAP
16182720|NCT01526213|Drug|Fexofenadine|This randomized, open-label, single-dose, 3-way crossover study in healthy volunteers will be conducted in the CTRC. Once subjects are identified as eligible to participate, based on their screening evaluation and according to inclusion/exclusion criteria, they will undergo 3 phases. By randomized crossover design, the subject will receive fexofenadine with water, grapefruit juice, or furanocoumarin-free grapefruit juice.
16182721|NCT01526200|Procedure|Contrast-enhanced intraoperative ultrasound|After entering the abdominal cavity, liver mobilization is achieved by dissecting the round and falciform ligaments. IOUS is carried out with a standard 3-6 MHz convex probe, and a 7.5-10 MHz micro convex probe. Staging was completed by CE-IOUS using the standard 3-6 MHz convex probe and the dedicated 1.88-3.76 MHz harmonic frequency probe. In all patients, 2.4 mL of sulphur-hexafluoride microbubbles (SonoVue®, Bracco, Milan, Italy) are injected through a peripheral vein by the anesthesiologist.
16182722|NCT01526174|Drug|Golimumab|Intratympanic injection 0.3ml First Arm: 1 injection Second Arm: 4 injections
16182723|NCT01526161|Drug|inhaled fluticasone propionate|100 micrograms
16182724|NCT01526161|Drug|salmeterol|50 m
16182725|NCT01526161|Drug|Montelukast|Double blind double dummy
16182726|NCT01526148|Drug|Lithium|Lithium will be initiated at 300 mg per day and titrated in 300 mg increments every 7days as tolerated with blood lithium levels > 0.6mEq/L.
16182727|NCT01526148|Drug|Quetiapine|Quetiapine will be started at 50 mg per day at bedtime and titrated up to 300 mg as tolerated over 1 week.
16182728|NCT01526135|Drug|mFolfirinox|"mFolfirinox every 14 days, 12 cycles, 24 weeks.
~mFolfirinox : Oxaliplatin (Eloxatin®) 85 mg/m² D1 over 2 hours, followed by Irinotecan (Campto®) 150 mg/m² D1 over 90 minutes to begin 30 min. after the Folinic acid infusion is started.
~Folinic acid 400 mg/m² (racemic mixture) (or 200 mg/m² if L-folinic acid is used), IV infusion over 2 hours.
~5-FU 2.4 g/m² IV continuous infusion over 46 hours (1200 mg/m²/ day)"
16190744|NCT01466244|Drug|cisplatin|
16182729|NCT01526135|Drug|Gemcitabine|Gemcitabine 1000 mg/m² IV infusion over 30 minutes, weekly, during 3 weeks + 1 week of rest (= 1 cycle) repeated 6 times (i.e., 6 cycles) during 24 weeks
16182730|NCT01526122|Drug|G0041(75/100mg)|G0041(75/100mg) 2 capsules(Clopidogrel 75mg & Aspirin 100mg in 1 capsule), PO
16182731|NCT01526122|Drug|Clopidogrel & Aspirin|Clopidogrel 75mg 2 tablets & Aspirin 100mg 2 capsules, PO
16182732|NCT01526109|Behavioral|Strength training group|Participants will undergo a training program set for the three functional groups, which lasted ten minutes, followed by thirty minutes of strength training twice a week consists of six exercises for major muscle groups: leg press, bench press, lat pull down, knee extension, knee flexion and Abdominal (3 sets of 10-12 repetitions at 60-80% of 1 RM with 3 min interval between sets and between workouts).
16182733|NCT01526109|Behavioral|Control group|Participants will undergo a training program set for the three functional groups of ten minutes duration, followed by thirty minutes of functional exercises twice a week (2-3 sets of 30 sec. At intervals of 60 s between stimuli) carry out a range of six functional exercises combining squats and isometric or dynamic exercises for the upper limbs and trunk without intensity
16182734|NCT01526109|Behavioral|Whole-body vibration training group|Participants will undergo a training program set for the three functional groups, which lasted ten minutes, followed by thirty minutes of exercise stimuli to whole-body vibration twice a week (2-3 sets of 30 sec. with frequency of stimulation at 30 Hz with 60 s intervals between stimuli), the platform will hold a range of six functional exercises combining squats and isometric or dynamic exercises for the upper limbs and trunk.
16182735|NCT01526096|Drug|G-CSF|G-CSF will be self-administered shot daily for 4 days pre-transplant. Up to 8 doses of G-CSF may be given. G-CSF will also be administered once daily under the skin beginning 5 days after your stem cell infusion until your white blood cell count is high enough
16182736|NCT01526096|Drug|Plerixafor|Plerixafor (self-administered shot)prior to the beginning of the stem cell collection. Up to 4 doses of plerixafor may be given.
16182737|NCT01526096|Procedure|Apheresis|Stem cell collection begins on day 5 and can last up to 3 days depending on the number collected.
16182738|NCT01526096|Drug|Melphalan|Melphalan chemotherapy 100mg/m2 for 2 days after your admission into the hospital for your ASCT procedure.
16182739|NCT01526096|Procedure|Stem cell re-infusion|Stem cells are thawed and reinfused back into the body via a catheter in the vein.
16182740|NCT01526096|Drug|Basiliximab|Basiliximab (20mg) given by IV infusion (through the vein) 20-30 minutes the day after ASCT.
16182741|NCT01526096|Device|CliniMACS CD25 microbeads and cell sorter|The stem cells collected during apheresis will be counted and treated with CD25 microbeads and processed by a special device called a CliniMACs machine which removes the regulatory T cells from you stem cell product.
16182742|NCT01526083|Other|Lacosamide|Strength: 200 mg, Form: Tablet, Frequency: Twice daily, Duration: 9 days
16182743|NCT01526083|Other|Warfarin|"Strength: 5 mg, Form: Tablet, Frequency: 1 single dose in each period
~In total, during the two periods, each healthy volunteer will receive 2 single doses 3 weeks apart.
~Duration: single dose"
16182744|NCT01526070|Drug|Intravitreal injection of Aflibercept|
16182745|NCT01526057|Biological|PF-05280586|1000 mg, IV on days 1 and 15
16182746|NCT01526057|Biological|MabThera|1000 mg, IV on days 1 and 15
16182747|NCT01526057|Biological|Rituxan|1000 mg, IV on days 1 and 15
16182748|NCT01526044|Device|Freestyle Navigator|Continuous glucose monitoring by subcutaneous measurement in the interstitial fluid
16182749|NCT01526031|Procedure|1:10,000 bee venom (BV) acupuncture|"after skin test for hypersensitivity to bee venom (0.05ml of 1:30,000 bee venom, SC at LI11)
~1st visit : SC 0.4ml of 1:10,000 BV at 4 points (0.1ml for each points)
~2nd visit : SC 0.6ml of 1:10,000 BV at 6 points (0.1ml for each points)
~3rd visit : SC 0.8ml of 1:10,000 BV at 8 points (0.1ml for each points)
~4th to 16th visit : SC 1.0ml of 1:10,000 BV at 10 points (0.1ml for each points)"
16182750|NCT01526031|Procedure|1:30,000 bee venom (BV) acupuncture|"after skin test for hypersensitivity to bee venom (0.05ml of 1:30,000 bee venom, SC at LI11)
~1st visit : SC 0.4ml of 1:30,000 BV at 4 points (0.1ml for each points)
~2nd visit : SC 0.6ml of 1:30,000 BV at 6 points (0.1ml for each points)
~3rd visit : SC 0.8ml of 1:30,000 BV at 8 points (0.1ml for each points)
~4th to 16th visit : SC 1.0ml of 1:30,000 BV at 10 points (0.1ml for each points)"
16182751|NCT01526031|Procedure|normal saline injection|"after skin test for hypersensitivity to bee venom (0.05ml of 1:30,000 bee venom, SC at LI11)
~1st visit : SC 0.4ml of normal saline at 4 points (0.1ml for each points)
~2nd visit : SC 0.6ml of normal saline at 6 points (0.1ml for each points)
~3rd visit : SC 0.8ml of normal saline at 8 points (0.1ml for each points)
~4th to 16th visit : SC 1.0ml of normal saline at 10 points (0.1ml for each points)"
16182752|NCT01526031|Procedure|physiotherapy|"Physiotherapy treatment will be provided at each visit after bee venom or saline injection.
~transcutaneous electrical nerve stimulation (TENS) for 15 minutes
~transcutaneous infrared thermotherapy (TDP) for 15 minutes
~manual physical therapy for 15 minutes
~simple home exercise program"
16182753|NCT01526018|Behavioral|Podee bottle|Infants will acclimate to the Podee bottle over the course of several weeks. All infants will consume meals from the Podee and their usual bottles.
16182754|NCT01526005|Drug|Transdermal Nicotine Patch|1 patch per day; dosages of 21 mg/day for 4 weeks, 14 mg/day for 2 weeks, and 7 mg/day for 2 weeks; 8 weeks total
16182755|NCT01526005|Drug|Transdermal Placebo Patch|1 patch per day; 8 weeks total
16182756|NCT01525992|Behavioral|Community pharmacist-led diabetes education program|A trained pharmacist will counsel each patient based on his/her individual needs about medications, life style and self-care. The pharmacist will use a checklist to document the type of education delivered to each patient. A glucometer is provided for each patient in this arm to monitor blood glucose daily. Three to six visits to the community pharmacy are set during the 6-months study period. At each visit, medication related problems and self-care issues are discussed with the patient and the glucometer test strips are provided for the following month. A telephone call will be made to each patient between visits to ensure adherence to drug therapy and resolve any problems .
16182757|NCT01525992|Other|Usual care|The baseline and 6-month follow-up visits to the community pharmacy will be required. If the physician prefers more visits to his office during the study period, it will be granted. The glucometer and a training session about diabetes self-care will be provide at the end of study for control group patients.
16182850|NCT01525407|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo myeloablative allogeneic PBSC transplant
16182758|NCT01525979|Behavioral|Task-related unilateral arm training|The training tasks will involve daily activities with unilateral proximal or distal upper extremity movements for 5 days/week for 1.5 hours/day for 4 consecutive weeks.
16182759|NCT01525979|Behavioral|Task-related bilateral arm training|This intervention emphasizes UE movements (gross or fine motor tasks) involved in daily activities but focus on both UEs moving synchronously. The duration and intensity of treatment will also be 5 days/week for 1.5 hours/day for 4 consecutive weeks.
16182760|NCT01525979|Behavioral|Robot-assisted bilateral arm training|The Bi-Manu-Track used in this project (Reha-Stim Co., Berlin, Germany) enables the symmetric practice of 2 movement patterns: forearm pronation-supination and wrist flexion-extension. Each movement has 3 computer-controlled modes: (1) passive-passive, with both arms being moved by the machine with speed, range of motion, and resistance individually adjustable; (2) active-passive, with the unaffected arm driving the affected arm in a mirror-like fashion; and (3) active-active, with both arms actively moving against resistance.
16182761|NCT01525979|Behavioral|Robot-assisted unilateral arm training|The robot-assisted unilateral arm training group will use mode 1 and 3: (1) passive, affected arm being moved by the machine with speed and range of motion individually adjustable; and (2) active, with the affected arm actively moving. This training program will add an additional mode: active-resistance, with the affected arm/wrist actively moving against resistance.
16182762|NCT01525966|Drug|carboplatin|Given IV
16182763|NCT01525966|Drug|paclitaxel albumin-stabilized nanoparticle formulation|Given IV
16182764|NCT01525966|Other|laboratory biomarker analysis|Correlative studies
16182765|NCT01525953|Drug|Chemotherapy|Chemotherapy according to standard
16182766|NCT01525953|Radiation|Radiotherapy|Radiotherapy according to local standard
16182767|NCT01525940|Device|PillCam Colon Capsule Endoscopy (Given® Diagnostic System)|2nd-generation CCE is 11.6x31.5 mm size, slightly bigger than previous capsule. It has 2 images with an angle of view increased to 172° degrees for each image. CCE-2 captures 35 images/sec. when in motion and 4 images/sec. when virtually stationary. Capsule battery life is at least 10 hours. The Recorder is an external receiving/recording and transmitting unit that receives data transmitted by the capsule. The portable Recorder consists of an antenna array which attaches to the body, a receiver and memory for accumulation of data during the exam. Data transmission is done via high capacity digital link. Workstation is a modified standard personal computer for reviewing videos generated from images acquired by the capsule, interpretation, analysis of acquired data and generating reports.
16182768|NCT01525927|Drug|chemotherapy|Chemotherapy for three cycles prior to radiotherapy
16182769|NCT01525927|Radiation|radiotherapy|Standard radiotherapy for non-responders vs reduced dose radiotherapy for responders.
16182770|NCT01525927|Radiation|Reduced dose radiotherapy|Patients who achieve a response to chemotherapy then go on to receive reduced dose radiotherapy.
16182771|NCT01525914|Drug|Dutasteride|dutasteride 0.5mg daily
16182772|NCT01525901|Drug|Insulin-Like Growth Factor-1 (IGF-1)|IGF-1 and placebo will each be administered for 3 months with a four-week washout period in between. IGF-1 will be administered for 3 months subcutaneously.
16182773|NCT01525901|Drug|Normal saline|Saline solution will be administered for three months subcutaneously.
16182774|NCT01525888|Procedure|stop angiotensin converting enzyme inhibitor or angiotensin receptor blocker (ACE-I/ARB)|stoping for 6 days treatment with angiotensin converting enzyme inhibitor or angiotensin receptor blocker
16182775|NCT01525875|Drug|Magnesium Oxide|"Part 1: 1000 mg elemental magnesium (given as one 800 mg capsule of magnesium oxide two times daily).
~Part 2: 1500 mg elemental magnesium (given as two 500 mg capsules of magnesium oxide in the morning and three 500 mg capsules of magnesium oxide in the evening)."
16182776|NCT01525875|Drug|Placebo|1000 mg (one 500 mg capsule two times daily) of placebo.
16182777|NCT01525862|Device|Balloon sinus dilation|
16182778|NCT01525849|Device|Balloon Sinus Dilation|Balloon sinus dilation using the XprESS Multi-Sinus Dilation Tool or the FinESS SInus Treatment
16182779|NCT01525849|Procedure|Functional Endoscopic Sinus Surgery|Endoscopic sinus surgery, specifically, maxillary antrostomy and uncinectomy with optional anterior ethmoidectomy
16182780|NCT01525836|Drug|rituximab; recombinant human thrombopoietin (rhTPO)|patients in recombination treatment group take Rituximab( intravenously ,100 mg weekly for 4 consecutive weeks); in combination with Rh-TPO( subcutaneously , 300U/kg for 14 consecutive days,followed by flexible treating dosage so as to keep the platelet count above 50×10^9/L until the 29th day)
16182781|NCT01525836|Drug|Rituximab|patients in recombinant treatment group take Rituximab intravenously at 100 mg weekly for 4 consecutive weeks（Day 1,8,15,22)
16182782|NCT01525823|Drug|BMS-754807 (IGR-IR/IR Inhibitor)|Tablets, Oral, 100mg, Once daily, Days 1 - 5 and 15 - 17
16182783|NCT01525823|Drug|Metformin|Tablets, Oral, (1000mg on Days 3 - 9) and (2000mg on Days 10 - 17), Once daily
16182784|NCT01525810|Drug|Peginterferon Lambda-1a (BMS-914143)|Observational study - No Intervention [subjects were previously treated with Peginterferon Lambda-1a (BMS-914143)]
16182785|NCT01525771|Other|Docetaxel|"The study medication will be administered every 3 weeks for a maximum of 8cycles. A study medication will be given to the patients.
~Docetaxel (-1 to 3 level)mg/m2 IV(D1) every 21 days (-1 level: 40, 1 level: 60, 2 level: 80, 3 level: 100)
~Xeloda 937.5 mg/m2/ day PO, twice a day(D1-D14) every 21 days
~Cisplatin 60mg/m2 IV (D1) every 21 days"
16182786|NCT01525758|Drug|SI000413|1 Tablet = 200mg, (400mg, 600mg or 800mg vs. placebo) for 8weeks
16182787|NCT01525758|Drug|microcrystalline cellulose|identical number of tablets to active drug groups
16182788|NCT01525745|Radiation|Radiosurgery/SBRT|1, 3 or 5 SBRT treatments
16182789|NCT01525745|Radiation|External Beam Radiation Therapy|10 consecutive days of standard radiation
16182790|NCT01525732|Procedure|Per Oral Endoscopic Myotomy|
16182791|NCT01525719|Drug|Everolimus|10 mg everolimus
16182846|NCT01525433|Behavioral|DVD|Participants will received a mailed DVD containing culturally appropriate information about the importance of cervical cancer screening
16182847|NCT01525433|Behavioral|Promotora|Participants will receive a home visit from a lay community health educator ('Promotora') and will be shown a DVD containing culturally appropriate information to educate participants about the importance of cervical cancer screening
16182848|NCT01525420|Behavioral|Acceptance Therapy (ACT)|ACT
16182849|NCT01525420|Other|Cognitive Behavioral Therapy (CBT)|CBT
16182792|NCT01525706|Drug|Ethanol and Paclitaxel Injection|Endoscopic ultrasound will be used to locate and assess the pancreatic cyst. The fluid contents will be aspirated using a fine needle and sent for tumor marker analysis and cytology. With the needle maintained in the same position, 99% ethanol will be injected into the cyst. After 3-5 minutes of lavage, the entire volume of fluid will be removed from the cyst. The same volume of paclitaxel minus 1 mL [3mg/ml diluted in normal saline from original concentration of 6mg/mL] will be injected and left in the cyst. The needle is then retracted and the procedure completed. Patients will receive oral prophylactic antibiotics for 5 days after the procedure. Clinical follow up with MRI imaging with be done at 6, 12, 18, and 24 months. For those with a persistent cyst at 12 months, a repeat EUS FNI procedure will be done.
16182793|NCT01525680|Other|Hydrocortisone augmented Prolonged Exposure Therapy|11 sessions of PE. 20 minutes prior to final eight sessions, 30 mg hydrocortisone is administered.
16182794|NCT01525680|Other|Prolonged exposure therapy with placebo administration|11 sessions of PE. 20 minutes prior to final eight sessions, placebo is administered.
16182795|NCT01525667|Biological|150M PLX-PAD|Single course, multiple IM injections
16182796|NCT01525667|Biological|300M PLX-PAD|Single course, multiple IM injections
16182797|NCT01525667|Biological|Placebo|Single course, multiple IM injections
16182798|NCT01525654|Behavioral|Peer Support Program|Partners, are interested in having a support person to talk with while others. Coaches initiate contact, usually via phone but can use email or face to face, with their Partner. During this initial contact, partners determine how often to speak up to a total of 6 months. Peer Support discussions focus on sharing information, education, support related to living with RA.
16182799|NCT01525641|Drug|Mirapex LA|Pramipexole Hydrochloride Hydrate
16182800|NCT01525628|Drug|midazolam|CYP3A probe drug
16182801|NCT01525628|Drug|BI 201335|HCV protease inhibitor
16182802|NCT01525628|Drug|tenofovir|nucleoside analogue
16182803|NCT01525628|Drug|caffeine|CYP1A2 probe drug
16182804|NCT01525628|Drug|tolbutamide|CYP2C9 probe drug
16182805|NCT01525628|Drug|tolbutamide|CYP2C9 probe drug
16182806|NCT01525628|Drug|midazolam|CYP3A probe drug
16182807|NCT01525628|Drug|caffeine|CYP1A2 probe drug
16182808|NCT01525628|Drug|pegylated interferon|HCV treatment
16182809|NCT01525628|Drug|BI 201335|HCV protease inhibitor
16182810|NCT01525628|Drug|BI 201335|HCV protease inhibitor
16182811|NCT01525628|Drug|BI 207127|HCV polymerase inhibitor
16182812|NCT01525628|Drug|BI 207127|HCV polymerase inhibitor
16182813|NCT01525628|Drug|BI 201335|HCV protease inhibitor
16182814|NCT01525628|Drug|BI 207127|HCV polymerase inhibitor
16182815|NCT01525628|Drug|ribavirin|HCV treatment
16182816|NCT01525628|Drug|ribavirin|HCV treatment
16182817|NCT01525628|Drug|ribavirin|HCV treatment
16182818|NCT01525628|Drug|pegylated interferon|HCV treatment
16182819|NCT01525628|Drug|ribavirin|HCV treatment
16182820|NCT01525628|Drug|caffeine|CYP1A2 probe drug
16182821|NCT01525628|Drug|tolbutamide|CYP2C9 probe drug
16182822|NCT01525628|Drug|BI 207127|HCV polymerase inhibitor
16182823|NCT01525628|Drug|midazolam|CYP3A probe drug
16182824|NCT01525628|Drug|BI 201335|HCV protease inhibitor
16182825|NCT01525628|Drug|BI 207127|HCV polymerase inhibitor
16182826|NCT01525628|Drug|ribavirin|HCV treatment
16182827|NCT01525615|Device|Respimat inhaler|Respimat inhaler
16182828|NCT01525615|Drug|tiotropium+olodaterol (low dose)|2.5 µg tiotropium + 5 µg olodaterol
16182829|NCT01525615|Drug|tiotropium + olodaterol (high dose)|5 µg tiotropium + 5 µg olodaterol
16182830|NCT01525615|Device|Respimat inhaler|Respimat inhaler
16182831|NCT01525615|Device|Respimat inhaler|Respimat inhaler
16182832|NCT01525615|Drug|placebo to tiotropium+olodaterol|comparator
16182833|NCT01525602|Drug|PLX3397|PLX3397 tablets, 200mg
16182834|NCT01525602|Drug|Paclitaxel|Paclitaxel IV
16182835|NCT01525589|Drug|PM01183|PM01183 drug product (DP) is presented as a lyophilized powder for concentrate for solution for infusion with two strengths: 1 mg/vial and 4 mg/vial
16182836|NCT01525576|Behavioral|Booster|3 week booster program + 2 additional weeks two months later for follow-up.
16182837|NCT01525550|Drug|sunitinib|Sunitinib capsules will be given orally at continuous daily dosing with a starting dose of 37.5 mg. One cycle is equal to 28 days.
16182838|NCT01525537|Drug|administration of sufentanil|10 microgram sufentanil were given when SPI above 50 for more then 20 sec
16182839|NCT01525537|Drug|sufentanil|sufentanil was given at standard practise
16182840|NCT01525524|Device|Transcranial Direct Current Stimulation|In active stimulation(active Transcranial Direct Current Stimulation), the anode is placed over the left dorsolateral prefrontal cortex and the cathode is placed over the right prefrontal cortex. They are located five centimeters ventrally of the primary motor area, which are located five centimeters laterally of the central point of the scalp (which is located on the intersection of the sagittal and median curves). The device will deliver a charge of 2mA for 30 minutes.
16182841|NCT01525511|Drug|A|"Subject will receive primaquine (PQ) then receive dihydroartemisinin-piperaquine (DHA-PQP)after 1 week washout period and receive PQ together with DHA-PQP for the third regimen after 8 weeks washout period.
~Primaquine:
~1 tablet of primaquine phosphate contains: 26.3 mg (15 mg base)
~Dosage: 2 tablets
~DHA-PQP:
~1 tablet of Eurartesim contains: DHA 40 mg: piperaquine 320 mg
~Dosage: 3 tablets"
16182842|NCT01525511|Drug|B|"Subject will receive primaquine (PQ) then receive PQ together dihydroartemisinin-piperaquine (DHA-PQP) after 1 week washout period and receive DHA-PQP for the third regimen after 8 weeks washout period.
~Primaquine:
~1 tablet of primaquine phosphate contains: 26.3 mg (15 mg base)
~Dosage: 2 tablets
~DHA-PQP:
~1 tablet of Eurartesim contains: DHA 40 mg: piperaquine 320 mg
~Dosage: 3 tablets"
16182843|NCT01525459|Procedure|Glioma resection|Patients will be treated with the standard surgical therapy - glioma resection.
16182844|NCT01525459|Other|Blood sampling|Blood samples used for measuring studied parameters will be taken within 10 days before surgery, one day after surgery and once more within 10 days following the operative procedure.
16182845|NCT01525446|Radiation|SBRT with proton beam radiation|4 consecutive days for the delivery of 48 Gy (tumors 3 cm or less) or 5 consecutive days for the delivery of 60 Gy (tumors of > 3 cm)
16182852|NCT01525407|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo myeloablative allogeneic PBSC transplant
16182853|NCT01525394|Drug|Lenvatinib|32 mg will be administered orally as three 4 mg and two 10 mg capsules as a single dose.
16182854|NCT01525394|Drug|Moxifloxacin 400 mg|Moxifloxacin 400 mg will be administered orally as one 400 mg tablet.
16182855|NCT01525394|Drug|Placebos (matched to 4 mg and 10 mg lenvatinib capsules).|The Placebo dose will consist of three 4 mg and two 10 mg placebo capsules.
16182856|NCT01525368|Behavioral|cognitive intervention|Complex modular cognitive intervention focussing on memory aspects (e.g. internal memory strategies, external memory aids), other cognitive functions (e.g. attention) as well as social interactions.
16182857|NCT01525329|Drug|5-Fluorouracil|All patients will receive one cream, 5-Fluorouracil, and will be instructed to apply the cream according to the randomization schema to AKs on either the right or left side of the face/scalp once a day for 6 days prior to PDT. A baseline measurement of the tumor's ability to produce PpIX will be done by applying methyl-aminolevulinic acid (Metvixia® topical cream) to the selected AKs and using the Aurora© dosimeter. Prior to Metvixia, and again 3 hours after application, surface measurements of the PpIX fluorescence will be taken. Then, the two largest precancer lesions (one on the left side, one on the right side) will be biopsied under local anesthesia, followed by red light PDT (lasting ~8 minutes). The biopsy sites will be shielded from the light with a circular spot bandage.
16182858|NCT01525316|Dietary Supplement|Bovine Lactoferrin|Infants will receive oral bovine lactoferrin (200 mg/Kg/day divided in three dosis) for 8 weeks. Lactoferrin will be dissolved in human milk or infant formula or in a 5% glucose solution. Each dose will be dissolved in a small volume so the maximum lactoferrin concentration will be 25mg/mL.
16182859|NCT01525316|Dietary Supplement|Maltodextrin|Infants will receive oral maltodextrin (200mg/Kg/day in three divided dosis) for 8 weeks. Maltodextrin will be dissolved in human milk or infant formula or in a 5% glucose solution. Each dose will be dissolved in a small volume so the maximum maltodextrin concentration will be 25mg/mL.
16182860|NCT01525303|Behavioral|Behavioral Treatment for Chronic Headache- Exercise Version|This behavioral treatment program consists of behavioral approaches to headache management: progressive muscle relaxation, stress-management training, and biofeedback. Skills for these techniques are presented during the clinic sessions, and supplemented with workbooks and audio CDs. In addition, all participants will receive a graduated exercise prescription of 20-30 minutes of moderate-intensity exercise, five days per week. They will be instructed to assess the intensity of their exercise using the Borg perceived exertion scale. Client contact sessions are as follows: Clinic Session (CS)1; Phone Session (PS) 1 (end of week1), CS 2 (end of week 4); PS 2 (end of week 6); CS 3 (end of week 8).
16182861|NCT01525290|Drug|Alteplase|Intravenous tissue plasminogen activator (Alteplase) 0.9 mg/kg body-weight up to a maximum of 90 mg, 10% as bolus, 90% over 1 hour as infusion
16182862|NCT01525290|Drug|Placebo|lyophilised powder to be reconstituted as solution indistinguishable from the active drug
16182863|NCT01525264|Behavioral|KIM-CHI|The intervention is based on cultural characteristics and context and focuses on changing (1) beliefs about breast cancer and screening, (2) knowledge of breast cancer and screening, (3) self-efficacy of confidence in one's ability to complete all the steps necessary for obtaining a mammogram including requesting a referral for mammogram from a physician. The KIM-CHI program also incorporates strategies for enhancing spousal support (perceived support received from husband). To standardize delivery of culture-relevant health behavior change information related to breast cancer screening to groups of women and their husbands separately, the KIM-CHI program uses a DVD with Korean role models, native Korean language, and male physician authentication as well as inclusion of spouses.
16182864|NCT01525264|Behavioral|Healthy Wife Control Group|Intervention group of couples who received education about importance of Healthy diet
16182865|NCT01525238|Drug|Dapagliflozin|Tablet, Oral, 2.5 mg, Single-dose
16182866|NCT01525238|Drug|Dapagliflozin|Tablet, Oral, 5 mg, Single-dose
16182867|NCT01525238|Drug|Dapagliflozin|Tablet, Oral, 10 mg, Single-dose
16182868|NCT01525225|Drug|Metformin immediate release (IR)|Tablet, Oral, 1000 mg, twice daily, 1 day
16182869|NCT01525225|Drug|Saxagliptin|Tablet, Oral, 5 mg, single-dose, 1 day
16182870|NCT01525225|Drug|Metformin IR|Tablet, Oral, 1000 mg, twice daily, 5 days
16182871|NCT01525225|Drug|Saxagliptin/Metformin XR FDC|Tablet, Oral, 2.5 mg Saxagliptin/1000 mg Metformin extended release (XR), Single-dose of 2 tablets. Fixed dose combination (FDC).
16182872|NCT01525225|Drug|Metformin XR|Tablet, Oral, 500 mg, Single-dose of 4 tablets
16182873|NCT01525212|Drug|BMS-929075|Oral Suspension, ≤ 25 mg, Once daily, 3 days
16182874|NCT01525212|Drug|BMS-929075|Oral Suspension, ≤ 100 mg, Once daily, 3 days
16182875|NCT01525212|Drug|BMS-929075|Oral Suspension, ≤ 400 mg, Once daily, 3 days
16182876|NCT01525212|Drug|BMS-929075|Oral Suspension, (≤ 800 mg, Once daily) OR (≤ 400 mg, Twice daily), 3 days
16182877|NCT01525212|Drug|Placebo matching BMS-929075|Oral Suspension, 0 mg, Once daily, 3 days
16182878|NCT01525212|Drug|Placebo matching BMS-929075|Oral Suspension, 0 mg, (Once daily for ≤ 800 mg group) OR (Twice daily for ≤ 400 mg group), 3 days
16182879|NCT01525173|Drug|0.1% brimonidine tartrate ophthalmic solution|1 drop of 0.1% brimonidine tartrate ophthalmic solution 3 times per day for 12 weeks.
16182880|NCT01525173|Drug|0.01% bimatoprost ophthalmic solution|1 drop of 0.01% bimatoprost ophthalmic solution once per day for 12 weeks.
16182881|NCT01525173|Drug|0.2% hypromellose lubricant eye drops|1 drop of 0.2% hypromellose lubricant eye drops 3 times per day for 12 weeks.
16182882|NCT01525173|Drug|latanoprost 0.005% ophthalmic solution|1 drop of latanoprost 0.005% ophthalmic solution once daily as run-in therapy for 30 days only.
16182883|NCT01525147|Biological|YHB1411-2: Level 2|IV infusion
16182884|NCT01525147|Biological|YHB1411-2: Level 3|IV infusion
16182885|NCT01525147|Biological|YHB1411-2: Level 4|IV infusion
16182886|NCT01525147|Biological|YHB1411-2: Level 5|IV infusion
16182887|NCT01525147|Biological|Placebo|IV infusion
16182888|NCT01525147|Biological|YHB1411-2: level 1|IV infusion
16182889|NCT01525134|Device|"Alere Determine lateral-flow urine lipoarabinomannan assay"|"lateral-flow (point-of-care) urine test to detect the lipoarabinomannan (LAM) component of the M. tuberculosis antigen in the urine of TB suspects, in vitro.
~Manufacturer: Alere"
16183101|NCT01523366|Drug|Ticagrelor|Min - 90mg/Max - 180mg tablets (loading dose)
16182890|NCT01525134|Device|"Alere Clearview ELISA urine LAM assay"|"ELISA-based urine test to detect the lipoarabinomannan component of the M. tuberculosis antigen in the urine of TB suspects, in vitro.
~Manufacturer: Alere."
16182891|NCT01525121|Other|Expiratory Rib Cage Compression|The therapist hands were positioned on the lower ribs, and the force was applied every two breaths only during the expiration, synchronizing the maneuver rate with the patient's respiratory rate. Then, the patients underwent a suctioning procedure, and a hyperinflation maneuver consisting of a 10 minutes period under pressure support ventilation of 35 cmH2O was done. In control intervention instead of the compressive maneuver the patients were kept on normal ventilation.
16182892|NCT01525108|Behavioral|Self monitoring of blood pressure|Electronic blood pressure device is provided for patients and he/she will be trained to measure blood pressure at home once daily(same time each day). A logbook is also provided to document the daily blood pressure level.
16182893|NCT01525108|Other|Usual Care|Four visits to the physician's office at 4th, 12th, 24th week in the study period with usual advice giving practice of the staff. At the end of the trial period, an electronic blood pressure device will be given to each patient in this arm.
16182894|NCT01525082|Drug|Capecitabine|Capecitabine by mouth twice daily on Days 1 to 14
16182895|NCT01525082|Drug|Temozolomide|Temozolomide by mouth daily on Days 10 to 14
16182896|NCT01525082|Biological|Bevacizumab|Bevacizumab IV over 30 to 90 minutes on Days 1 & 15
16182897|NCT01525069|Drug|Floxuridine|
16182898|NCT01525069|Drug|Dexamethasone|
16182899|NCT01525069|Drug|Gemcitabine|
16182900|NCT01525069|Drug|Oxaliplatin|
16182901|NCT01525056|Radiation|ct and mri scans|ct and mri scan preradiation and postradiation
16182902|NCT01525056|Radiation|ct, mri and pet scan|ct, mri and pet scans preradiation and postradiation
16182903|NCT01525056|Radiation|ct, mri and pet scans|single arm with ct, mri and pet scans pre and post radiation
16182904|NCT01525043|Drug|Naproxen|Naproxen 500mg BID for the first 2 weeks
16182905|NCT01525043|Drug|Synera patch twice daily|1 synera patch to cover the treatment area applied for 4 hours, twice daily for the first 2 weeks
16182906|NCT01525043|Drug|Synera patch for 12hrs/day|1 synera patch to cover the treatment area applied for 12 hours, daily for the first 2 weeks
16182907|NCT01525043|Drug|Naproxen|500mg bid
16182908|NCT01525043|Drug|Synera|Topical appication of single patch to elbow for 12hrs/day
16182909|NCT01525043|Drug|Synera|Single patch applied to elbow for 4hrs/twice daily
16182910|NCT01525017|Biological|Combig-DC (allogeneic dendritic cells) Cancer Vaccine|Cryopreserved dendritic cell suspension of 10 million cells per ml in heat-inactivated plasma, supplemented with 10% dimethyl sulfoxide (DMSO).
16182911|NCT01525004|Drug|High-Dose trivalent inactivated influenza vaccine|0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.
16182912|NCT01525004|Drug|Standard dose trivalent inactivated influenza vaccine|0.5 mL standard dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine
16182913|NCT01524991|Drug|Gemcitabine|Gemcitabine 1000 mg/m2 Days 1 & 8 (all cycles)
16182914|NCT01524991|Drug|Cisplatin|Cisplatin 70 mg/m2 Day 1 (all cycles)
16182915|NCT01524991|Drug|Ipilimumab|Ipilimumab 10 mg/kg Day 1 (start cycle 3)
16182916|NCT01524978|Drug|cetuximab|Escalating doses administered on Day 1 and then once weekly by intravenous infusion.
16182917|NCT01524978|Drug|vemurafenib|Escalating doses given orally twice a day starting on Day 2
16182918|NCT01524978|Drug|vemurafenib|960 mg vemurafenib orally twice a day until disease progression, unacceptable toxicity, or withdrawal of consent.
16182919|NCT01524965|Procedure|Immediate mobilisation after locking-plate osteosynthesis|"Immediate passive range of motion exercises are begun postoperatively, after 3 weeks, active unloaded mobilisation begins after three weeks and active, loaded use is allowed 6 weeks postoperatively.
~Surgical procedure is open reduction of the fracture and internal fixation of the fracture using a locking plate using standard deltopectoral approach and AO principles in fracture management."
16182920|NCT01524965|Procedure|Standard mobilisation after locking plate osteosynthesis|"Immediately postoperatively the arm is held in a sling, active mobilisation of healthy joints and pendel exercises are befun. Passive range of motion exercises of the shoulder are begun 3 weeks postoperatively. Active mobilisation begins after six weeks.
~Surgical procedure is open reduction of the fracture and internal fixation of the fracture using a locking plate using standard deltopectoral approach and AO principles in fracture management."
16182921|NCT01524965|Device|Osteosynthesis with a locking plate (Philos)|Standard open reduction and internal fixation using a deltopectoral approach. Fracture fixation is done using a locking plate (Philos, Synthes) following the AO principles of fracture management.
16182922|NCT01524952|Device|combined thermal and electrical muscle stimulation (cTEMS)|cTEMS in three 60-minute sessions per week for 8 weeks
16182923|NCT01524939|Drug|immunoglobulin G|Intravenously administer a single dose of the product (2g/kg) for at least 12 hours
16182924|NCT01524926|Drug|Crizotinib (PF-02341066)|For patients of 15yo and older, Capsules of 200 and 250 mg Daily dose of 500, 400 or 250 mg/day depending on toxicitie; for patients younger than 15yo, 280 mg/m²/dose BID, with reductions allowed to 80% as first reduction and to 60% as second reduction respectively of the initial dose.
16182925|NCT01524913|Drug|Hyaluronic acid|1 cc hyalgan to be injected into superior joint space
16182926|NCT01524913|Drug|Corticosteroid|1cc celestone (6 mg/cc) will be injected into the joint space
16182927|NCT01524913|Drug|Lactated Ringers|1 cc lactated ringers solution will be injected into the joint space
16182928|NCT01524887|Biological|Immune Globulin Intravenous (Human), 10% Solution|Intravenous infusion every 2 weeks over 18 months
16182929|NCT01524887|Biological|Human albumin 0.25%|Intravenous infusion every 2 weeks over 18 months
16182930|NCT01524874|Dietary Supplement|Vitamin D3|10,000 IU per Day for 12 Weeks
16182931|NCT01524874|Dietary Supplement|Vitamin D3|10,000 IU per Day for 12 Weeks
16182932|NCT01524874|Dietary Supplement|Vitamin D3|10,000 IU per Day for 12 Weeks
16182933|NCT01524861|Drug|Placebo|a placebo tablet bis in die for 12 months
16182934|NCT01524861|Drug|alpha-lipoic acid|alpha-lipoic, tablets of acid 400 mg bis in die (800 mg/day), for 12 months
16182935|NCT01524861|Drug|L-acetyl carnitine|L-acetyl carnitine tablets, 500 mg bis in die (1000 mg/day), for 12 months
16182936|NCT01524848|Drug|Pazopanib|Two (2) tablets of 400 mg given once daily continuously
16182937|NCT01524809|Drug|biphasic insulin aspart 30|Dose individually adjusted. Administrated subcutaneously (s.c., under the skin) three times a day for 15 days in each treatment period. A wash-out period of 2-8 weeks will take place between treatment periods.
16182938|NCT01524809|Drug|biphasic insulin aspart 70|Dose individually adjusted. Administrated subcutaneously (s.c., under the skin) three times a day for 15 days in each treatment period. A wash-out period of 2-8 weeks will take place between treatment periods.
16182939|NCT01524796|Other|No intervention. Non-interventional study|No intervention. Non-interventional study
16182940|NCT01524783|Drug|Everolimus|Participants were treated with everolimus 10 mg (two 5 mg tablets) once daily orally taken
16182941|NCT01524783|Drug|Placebo|Participants were treated with two tablets of matching placebo once daily orally taken.
16182942|NCT01524783|Other|Best suportive care (BSC)|Best supportive care includes all care provided to participants deemed necessary by the treating physician, such as but not restricted to anti-diarrheals and analgesics. The optimal care of the patient is based on the treating physician's best medical judgment.
16182943|NCT01524770|Biological|Dulaglutide|Administered by subcutaneous (SC) injection
16182944|NCT01524757|Drug|Pantoprazole|pantoprazole 40mg 1dd1; 12 months
16182945|NCT01524744|Drug|Pimecrolimus ointment|Case group used drugs 3 times a day for 2 months and then didn't eat or drink for 20 minutes after use
16182946|NCT01524744|Drug|Adcortyl|triamcinolone acetonide 0.1% in orabase
16182947|NCT01524731|Drug|Saline|Normal Saline
16182948|NCT01524731|Drug|Dexamethasone|4 mg
16182949|NCT01524731|Drug|Dexamethasone|8 mg
16182950|NCT01524718|Radiation|Imaging with two X-ray image intensifiers|Two fluoroscopy apparatus one in the AP plane and the other as the axial plane.
16182951|NCT01524705|Drug|"GLIPULIN: [insulin glargine, metformin, exenatide (GLP-1-agonist)]"|Glargine-injectable, variable, QD, 6 months Metformin-oral, up to 1000mg, BID, 6 months Exenatide-injectable, 5mcg, BID, 6 months
16182952|NCT01524705|Drug|Insulin glargine, metformin, prandial insulin|Approximately 60 type 2 DM participants will be instructed in AHA/ADA meal plan. Insulin Glargine, metformin and one of 3 prandial insulins will be used as combination strategy to control individual HBA1Cs between 6.7 and 7.3%. Prandial Insulins (aspart, glulisine or lispro)
16182953|NCT01524692|Drug|Dovitinib (TKI258)|500 mg orally on a 5-days on/2-days off schedule each week of a 4-week (28-day) cycle. Treatment will continue until progression as defined by RECIST, unacceptable adverse events, patient refusal to continue on study, or physician's decision to withdraw the patient.
16182954|NCT01524679|Drug|Pegylated interferon alfa-2a plus nucleos(t)ide(s)|Pegylated interferon alfa-2a, s.c. 180 μg 1x/wk in addition to nucleos(t)ide(s)
16182955|NCT01524653|Drug|Rosuvastatin|20 mg po od
16182956|NCT01524653|Drug|Placebo|20 mg po od
16182957|NCT01524640|Biological|Killed Bivalent (O1 and O139) whole cell oral cholera vaccine|1.5 ml single dose oral administration on day 0 and day 14
16182958|NCT01524640|Biological|Placebo|1.5 ml oral administration on day 0 and day 14
16182959|NCT01524627|Drug|Varenicline|Varenicline will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.
16182960|NCT01524627|Drug|Placebo|Placebo will be prescribed to non-abstinent smokers at the same doses as have been demonstrated to be clinically effective for Varenicline: 0.5 mg twice a day for 3 days and then 1mg twice daily for the remainder of the treatment course of 8 weeks.
16182961|NCT01524614|Procedure|nasal mask|nasal mask use instead of face mask
16182962|NCT01524601|Drug|Rosuvastatin|20 mg rosuvastatin for 4 weeks
16182963|NCT01524575|Drug|gemcitabine and oxaliplatin|Excision repair cross-complementation group 1 (ERCC1) protein and mRNA expression predicts response to oxaliplatin - patients whose cancers make small amounts of ERCC1 are much more likely to respond to cisplatin than those whose tumors produce large amounts.
16182964|NCT01524536|Drug|prednisone|Glucocorticoids are considered the first- line therapy for hypereosinophilic syndrome. Although decreased expression of the GC receptor on the surface of eosinophils was implicated in 3 out of 5 patients with GC-resistant HES, the mechanisms of decreased or absent GC response is largely unexplored.
16182965|NCT01524510|Radiation|CT scan|low dose radiation scan without contrast without and with MRA
16182966|NCT01524510|Device|Alice PDx polygraphy|Alice PDx polygraphy (Respironics)
16182967|NCT01524497|Drug|Trazodone|75mg tablet/150 mg tablet
16182968|NCT01524497|Drug|Placebo|Reference drug: trazodone hydrochloride prolonged-release tablet placebo (corresponding dummy drug of 75mg, 150mg active drug)
16182969|NCT01524471|Procedure|Per Oral Endoscopic Myotomy|
16182970|NCT01524458|Procedure|Per-Oral Endoscopic Myotomy|To perform myotomy for lower esophageal sphincter using endoscope through a long submucosal tunnel
16182971|NCT01524445|Other|bortezomib retreatment due to relapse|Patients who received bortezomib-containing chemotherapy as first-line treatment for MM, experienced partial response or better, and were re-treated (second-line) with bortezomib (for at least 3 cycles) due to a relapse of the disease after a treatment free interruption of at least 6 months
16182972|NCT01524432|Drug|Anti-fungal agent (Clotrimazole) loaded microcapsules|Clotrimazole loaded microcapsules padded on socks and the patient should wear the socks every day for 2 weeks
16182973|NCT01524432|Drug|Placebo|No drug loaded microcapsules socks
16182974|NCT01524406|Drug|HPP593|Oral, twice a day.
16182975|NCT01524406|Drug|Placebo|Oral, twice a day.
16182976|NCT01524380|Drug|Ginkgo biloba extract|400mg/day, twice a day, 10 weeks
16182977|NCT01524380|Drug|Placebo|twice a day, 10 weeks
16182978|NCT01524367|Drug|saline|We administrate the normal saline (single bolus, 0.01ml/kg) intravenously at time of oral cavity sealing.
16182979|NCT01524367|Drug|Dexmedetomidine|We administrate the dexmedetomidine (single bolus, 1 ug/ks) intravenously at time of oral cavity sealing.
16182980|NCT01524354|Procedure|maintenance of anesthesia|intraoperative maintenance of anesthesia with propofol under control of cerebral state index at 40-60 points
16190745|NCT01466244|Genetic|gene expression analysis|
16182981|NCT01524354|Procedure|maintenance of anesthesia|intraoperative maintenance of anesthesia with propofol according to recommendations of the manufacturer
16182982|NCT01524341|Drug|KAE609|KAE609 was supplied as capsules for oral use.
16182983|NCT01524315|Drug|Vitamin B1-ratiopharm|300 mg Thiaminchloridhydrochlorid, once, intravenous, preoperative
16182984|NCT01524315|Drug|Placebo|100 ml normal saline, intravenous, preoperative
16182985|NCT01524302|Drug|Ceftaroline|600 mg Q12h
16182986|NCT01524302|Drug|Levofloxacin|750 mg QD
16182987|NCT01524289|Drug|Anacetrapib|One oral tablet, orally once daily for 52 weeks
16182988|NCT01524289|Drug|Placebo|One oral tablet once daily for 52 weeks
16182989|NCT01524250|Drug|corticosteroids|1250mg of oral prednisone daily for 3 days
16182990|NCT01524250|Drug|corticosteroids|1000mg IV methylprednisolone daily for 3 days
16182991|NCT01524237|Drug|LY2979165|Capsules administered orally
16182992|NCT01524237|Drug|LY2140023|Tablets administered orally
16182993|NCT01524237|Other|Placebo|Administered orally
16182994|NCT01524237|Other|Ketamine|Administered intravenously (IV)
16182995|NCT01524224|Drug|LY2495655|administered intravenously
16182996|NCT01524211|Device|Zenith® t-Branch|The t-Branch Endovascular Graft (Zenith® t-Branch) is a tubular graft with four branches and a covered stent at the proximal end that contains barbs for additional fixation of the device. The purpose of the branches is to allow uninterrupted blood flow to visceral vessels of the aorta. The graft is designed to be connected with celiac, superior mesenteric and two renal arteries via self-expanding covered bridging stents. Although the standard Zenith t-Branch has four branches, it is anticipated that a small number of custom-made three branch devices will be included in this study for those patients in whom one of the visceral vessels is chronically thrombosed.
16182997|NCT01524198|Drug|Budesonide|500 mcg budesonide plus Albuterol plus ipratropium bromide (IB) nebulization, 3 doses back to back
16182998|NCT01524198|Drug|Normal saline|0.5 ml to 1.5 ml normal saline (to complete 3 mls total volume), plus albuterol plus ipratropium bromide nebulizations 3 doses back to back
16182999|NCT01524185|Behavioral|FamilyLive|Multi-therapist family mental health treatment for families with a history of intergenerational neglect and trauma
16183000|NCT01524185|Behavioral|Standard Mental Health Treatment|Standard trauma-informed mental health treatment
16183001|NCT01524172|Behavioral|Yoga Based Psychotherapy Group|YBPG promotes self-regulation (attention span and physical and verbal expression/outbursts); self-soothing (breathing and movement techniques that physiologically calm when the child encounters stress or reminders of trauma); competency (successful social interaction, appropriate expression of needs and feelings, healthy coping with stress or crisis); self-awareness (of thoughts and feelings by first increasing awareness of the body and its sensations through yoga); self-esteem (positive self-regard, increase accomplishments and awareness that all individuals have different abilities); and safety and personal boundaries (establishing personal boundaries and respecting others' personal boundaries, differentiate safe and unsafe behaviors and situations).
16183002|NCT01524172|Behavioral|Standard Mental Health Treatment|Trauma and evidence informed therapy
16183003|NCT01524159|Dietary Supplement|bromelain capsule|Bromelain group received bromelain capsule for 12 weeks period. The 1050 mg dosage of bromelain was divided into three capsules and to be taken two (2 x 350 mg) after breakfast and another one (350 mg) after dinner. The capsules should be taken two hours after the meals.
16183004|NCT01524159|Dietary Supplement|placebo (wheat starch)|Placebo group received placebo capsule (wheat starch) for 12 weeks period. The 1050 mg dosage of wheat starch was divided into three capsules and to be taken two (2 x 350 mg) after breakfast and another one (350 mg) after dinner. The capsules should be taken two hours after the meals.
16183005|NCT01524146|Procedure|Photodynamic Therapy|"PDT is a therapeutic approach that specifically targets neoplastic cells.
~• PDT involves three components:
~Photofrin or a similar Photosensitizing agent that would be injected 3 days prior to laser activation of the agent.
~Laser System - For laser energy delivery to activate the photosensitizing agent and induce tumor tissue necrosis
~Optic Fiber - Delivery Fiber used along with the laser system to achieve Photoactivation of the photosensitizing agent.
~Technique:
~Subjects will be injected with Photofrin or similar drug. 3 days post injection, the subject will receive photodynamic therapy during an Endoscopic Retrograde cholangiopancreatography (ERCP) procedure. Subject will undergo stenting as part of standard of care procedure post photodynamic therapy.
~Subject may undergo multiple photodynamic therapy sessions with a gap of at least 3 months."
16183006|NCT01524133|Drug|Sertraline|Initial baseline dose of 25 mg/day. Clinician will attempt to titrate patients to at least 100 mg/day and up to 200 mg/day if tolerated by week 8.
16183007|NCT01524133|Behavioral|Prolonged Exposure Therapy|up to 13 sessions of prolonged exposure
16183008|NCT01524120|Device|Endoscopy (EPK-i, Pentax, Tokyo, Japan)|Patients will undergo white-light endoscopy. Any mucosal lesions will be recorded and findings will be compared to histopathological and clinical results.
16183009|NCT01524120|Device|Endomicroscopy (iCLE, Pentax, Tokyo, Japan)|Patients will undergo endomicroscopy. Data will be recorded and findings will be compared to histopathological and clinical results.
16183010|NCT01524120|Device|Endoscopy (EPK-i, Pentax, Tokyo, Japan)|Patients will undergo white-light endoscopy. Any mucosal lesions will be recorded and findings will be compared to histopathological and clinical results.
16183011|NCT01524120|Device|Endomicroscopy (iCLE, Pentax, Tokyo, Japan)|Patients will undergo endomicroscopy. Data will be recorded and findings will be compared to histopathological and clinical results.
16183012|NCT01524094|Drug|Systemic chemotherapy alone (oxaliplatin, 5-fluorouracil, isovorin)|Oxaliplatin 100 mg/ m2 as a 2 h iv infusion + 5-fluorouracil 400 mg/ m2 iv bolus + Isovorin 100 mg/ m2 as a 2 h infusion followed by 5-fluorouracil 2400 mg/ m2 as a 46 h infusion. Each cycle is given every other week until 12 cycles have been administered.
16183013|NCT01524094|Procedure|Cytoreductive surgery (CRS) plus postoperative intraperitoneal chemotherapy (5-fluorouracil, isovorin)|Cytoreductive surgery has the goal of completely resecting all visible tumor tissue in the abdomen. Sequential postoperative intraperitoneal chemotherapy has the purpose of an adjuvant treatment to eradicate microscopic residual tumor and prevent recurrences in the abdomen. The chemotherapy regimen consisted of intraperitoneal 5-fluorouracil 550 mg/ m2 and intravenous isovorin 30 mg/ m2 day 1-6 med cycles every 4-6 weeks. Six cycles were planned.
16183102|NCT01523366|Drug|Clopidogrel|75mg (once daily)/Max - 600mg tablets (loading dose)
16183014|NCT01524081|Drug|Metronidazole, Cefuroxime|"administration of Cefuroxime 1.5 g and Metronidazole 1g in 2 following intravenous infusions 60 minutes prior the surgery.
~- Cefuroxime in 100ml saline
~- Metronidazole in 500ml saline"
16183015|NCT01524081|Drug|Amoxicillin (+ clavulanic acid) and Fluconazole|"Administration of amoxicillin (+ clavulanic acid) 2.4 g and Fluconazole 800mg in 2 following intravenous infusions 60 minutes prior the surgery.
~- 2x amoxicillin in 100ml saline
~- Fluconazole in 500ml saline"
16183016|NCT01524081|Drug|Placebo|"Administration of saline infusion (Natrii chloridum: 9,0 g/l) 60 minutes prior the surgery
~- 100ml saline solution
~- 500ml saline solution"
16183017|NCT01524081|Drug|Placebo|"Administration of saline infusion (Natrii chloridum: 9,0 g/l) 60 minutes prior the surgery
~- 2x 100ml saline solution
~- 500ml saline solution"
16183018|NCT01524068|Drug|Standard Steroid Treatment|One gm of methylprednisolone i.v., on day 0, followed by 40 mg/day i.v. on days 1-4, and days 6-12 (or the p.o. prednisone equivalent). Methylprednisolone 100 mg i.v. will be administered on days 5 and 13. Steroid doses will then be 20 mg methylprednisolone i.v. (or p.o. prednisone equivalent) from days 14-28, and then reduced thereafter at the discretion of the PI at each site.
16183019|NCT01524068|Drug|The Standard Steroid Treatment, Plasma Exchange and rituximab|The Standard Steroid Treatment and, after insertion of a dialysis/apheresis catheter into a central vein, followed by initiation of the PEX and rituximab regimens.
16183020|NCT01524055|Device|Single-Balloon-Enteroscopy with Air as insufflation gas.|Single-Balloon-Enteroscopy will be performed using Air as insufflation gas to inflate the intestine for complete examination.
16183021|NCT01524055|Device|Single-Balloon-Enteroscopy with CO2 as insufflation gas.|Single-Balloon-Enteroscopy will be performed using CO2 as insufflation gas to inflate the intestine for complete examination.
16183022|NCT01524042|Procedure|Pants for colonoscopy|We divide the patients into group 1 and group 2. The group 1 wear a conventional single pants and group 2 wear a novel double pants.
16183023|NCT01524016|Drug|68Ga-DOTATATE|Intravenous injection of one dosage of 72-185MBq (2-5 mCi) 68Ga-DOTATATE solution. Tracer doses of 68Ga-DOTATATE will be used to image tumors by Positron Emission Tomography / computed tomography (PET/CT)
16183024|NCT01524003|Procedure|cryotherapy|cryotherapy treatment of the uterine cervix
16183025|NCT01524003|Procedure|Colposcopy|Colposcopy, biopsy and LEEP based on the pathology results
16183026|NCT01523990|Drug|TG-2349|Supplied as oral liquid formulation in pre-filled glass syringe. Two dose strengths, 25 mg TG-2349 (25 mg/mL in PEG 400, 1.1 mL fill) and 200 mg TG-2349 (50 mg/mL in PEG 400, 4.1 mL fill), are filled into 5-mL type 1 glass syringes. Required doses during clinical study are to be dispensed using the combination of the two dose units. The entire content of the syringe is to be taken by mouth.
16183027|NCT01523990|Drug|placebo|Available in two different unit doses, 1.1 mL and 4.1 mL PEG 400 in 5-mL type 1 glass syringes. They are identical in appearance and similar in weight to TG-2349 oral liquid syringes.
16183028|NCT01523977|Drug|Everolimus|Orally, daily days 1-32 per assigned dose level
16183029|NCT01523977|Drug|Prednisone|40 mg/m2/day orally 3 x daily days 4-32
16183030|NCT01523977|Drug|Vincristine|1.5 mg/m2 IV daily on days 4, 11, 18, and 25
16183031|NCT01523977|Drug|PEG-Asparaginase|2,500 U/m2 IV 1 x daily on days 5 and 18
16183032|NCT01523977|Drug|Doxorubicin|30 mg/m2 IV on days 4 and 5
16183033|NCT01523977|Drug|Dexrazoxane|300 mg/m2 IV on days 4 and 5
16183034|NCT01523964|Other|Testing with EIM|
16183035|NCT01523938|Behavioral|Hypnotherapy|Pre- (one session) and postoperative (two sessions) Hypnotherapy
16183036|NCT01523925|Behavioral|dCIT|This dCIT group focuses on restriction on movement of the unaffected hand by placement of the hand in a mitt for 6 hours/day and intensive training of the affected upper extremity in functional tasks 1.5 hours/weekday, for 4 weeks. The level of challenge will be adapted based on patient ability and improvement during training. Patients will be encouraged to initiate the designed therapeutic functional activities.
16183037|NCT01523925|Behavioral|BAT|The BAT group concentrates on the simultaneous movements of both the affected and unaffected upper extremity on robot for 1.5 hours/day, 5 days/week for 4 weeks.
16183038|NCT01523925|Behavioral|Control intervention group|The conventional intervention group is designed to control for the duration and intensity of patient-therapist interactions and therapeutic activities (1.5 hours/day, 5 days/week, for 4 weeks). Therapy in the control intervention group will involve training for coordination, balance, and movements of the affected upper extremity, as well as compensatory practice on functional tasks with the unaffected upper extremity or both upper extremities.
16183039|NCT01523925|Behavioral|Functional electrical stimulation|
16183040|NCT01523912|Device|Radiofrequency ablation of dysplastic mucosa (HALO)|Gastric ablation is performed using the HALO Ablation System (BÂRRX Medical Inc., Sunnyvale, CA, USA). A HALO90 ablation catheter, which is mounted on the tip of an endoscope, is used. Radiofrequency energy is delivered at 40 W/cm2 and 15 J/cm2 via a 13 x 20 mm electrode. All patients will have two RFA sessions 8 weeks apart with the same area being ablated in consecutive endoscopies. The precise area to ablated in the second RFA session is determined by referring to careful measurements that utilized gastric landmarks (a typical notation may specify that the lesion extends from 2 to 5 cm proximal of the pylorus in the 5 o'clock position and is 4 cm wide) as well as to digital image recordings that are taken during the first RFA.
16183041|NCT01523899|Device|Xpert MRSA/SA SSTI|Use of Xpert MRSA/SA SSTI assay
16183042|NCT01523899|Diagnostic Test|Standard culture|
16183043|NCT01523886|Drug|Rocuronium|Intravenous use: 0.3 mg/kg before intubation and 0,7 mg after intubation followed by infusion with 0,3-0,4 mg/kg/h
16183044|NCT01523886|Drug|Rocuronium|Intravenous use: 0,3 mg/kg followed by NaCl-infusion
16183045|NCT01523860|Drug|Rituximab, Mitoxantrone, Bendamustine|Rituximab will be supplied as 375 mg/sqm for i.v.administration.Mitoxantrone will be supplied as 8 mg/sqm for i.v.administration.Bendamustine will be supplied as 90 mg/sqm for i.v.administration
16183046|NCT01523847|Drug|MBVD (Myocet+BVD)|"MBVD will be scheduled as follows:
~Myocet 25 mg/mq i.v. day 1 and 15 Bleomycin 10 mg/mq i.v. day 1 and 15 Vinblastine 6 mg/mq i.v. day 1 and 15 Dacarbazine 375 mg/mq i.v. day 1 and 15"
16183103|NCT01523353|Behavioral|Exercise Intervention|4 week personalised exercise program on a static cycle. Supervised in a hospital environment
16183175|NCT01522807|Drug|PF-05190457|100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fasted state
16190746|NCT01466244|Genetic|microarray analysis|
16183047|NCT01523834|Drug|Panobinostat|"Induction Phase: Patients will receive panobinostat for 6 courses (1 course = 28 days). Consolidation phase (courses 7-12). Maintenance phase (course 13-end of therapy).
~Panobinostat should be taken p.o. at the dose of 40 mg/day 3-times every week (QW) as part of a 4 week treatment cycle. The dose of panobinostat may be modified: the 1st dose adjustment consists in the modification of drug administration from 3 times every week (QW) to 3 times every other week (QOW). Levels lower than 30 mg 3 times QOW is not permitted."
16183048|NCT01523821|Drug|Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia]|Alpha 1-Proteinase Inhibitor, Human 1 MG [Glassia] at various levels over different days
16183049|NCT01523808|Drug|GRASPA|Each patient will receive one administration of GRASPA . A stepwise increase of 4 single doses of GRASPA will be administered to cohorts of 3 patients per dose
16183050|NCT01523795|Other|Motion-controlled video gaming|Play of motion-controlled video games for one hour
16183051|NCT01523795|Other|Traditional video gaming|Participants played traditional video games for one hour
16183052|NCT01523795|Other|Television watching|Participants watched television for one hour
16183053|NCT01523782|Drug|GRASPA|Each patient will receive GRASPA at day 3 of the induction 1 phase. If no toxicity related to investigational product is observed and if the patient's state of health allows it, a second injection, at the identical dose, will be administered at Day 6 of Induction 2 phase
16183054|NCT01523769|Procedure|Umbilical Cord Milking|Approximately 10 cm of umbilical cord was milked toward the baby immediately following delivery. (The blood remaining in the umbilical cord after delivery is squeezed in the direction from the placenta (remaining inside the uterus) toward the newborn baby.)
16183055|NCT01523756|Device|test product 1: new ostomy base plate with Coloplast as manufacturer|test product 1 is tested first
16183056|NCT01523756|Device|test product 2: new ostomy base plate with Coloplast as manufacturer|test product 2 is tested first
16183057|NCT01523743|Device|SpeediCath Compact|The SpeediCath Compact intermittent catheter is used for single-use urinary bladder drainage through the urethra.
16183058|NCT01523743|Device|Standard care|The coated intermittent catheter normally used by subject
16183059|NCT01523730|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|Subjects will undergo two testing weeks (active and sham rTMS treatment), washout period ≥ 1 month between the testing weeks. rTMS treatment sessions will take place twice daily on days 1-3 of each test week. Active treatment will be delivered at 90% resting motor threshold intensity. Stimulation will be administered at 20 Hz with 25 stimulation trains of 30 stimuli each with an inter-train interval of 30 sec at equivalent stimulation parameters as those used in our pilot trial. Stimulation Site: Advanced neuronavigation methods will be used to target rTMS to the dorsolateral prefrontal cortex following a T1 weighted MRI scan.
16183060|NCT01523730|Device|Sham Repetitive Transcranial Stimulation (rTMS)|Subjects will undergo two testing weeks (active and sham rTMS treatment) administered in a randomized order, to which both experimenter and participant will be blind. There will be a washout period of at least one month between the testing weeks to ensure that any changes in cortical function induced by rTMS have returned to baseline. rTMS treatment sessions will take place twice daily on days 1-3 of each test week. Sham Condition: A single-wing tilt rTMS coil position producing somatic sensation (contraction of scalp muscles) with minimal direct brain effects will be used (same stimulation parameters and site as active condition).
16183061|NCT01523704|Device|BIOTRONIK Home Monitoring System|Home Monitoring system transfers implantable device's data to the main server via internet.
16183062|NCT01523704|Device|BIOTRONIK Home Monitoring System with In-office Follow-up|
16183063|NCT01523691|Behavioral|Repeated sleep restriction and recovery|Repeated cycles of sleep restriction and sleep recovery
16183064|NCT01523691|Behavioral|Control sleep|Regular amounts of sleep across study protocol
16183065|NCT01523678|Drug|Filgrastim|All subjects will receive standard treatment with paclitaxel followed by carboplatin intravenously during 18 weeks. Filgrastim (Neupogen) will be given prophylactically on day 5. An additional dose will be given on day 6 in case of severe neutropenia during the course of the trial.
16183066|NCT01523678|Drug|Paclitaxel|All subjects will receive standard treatment with paclitaxel followed by carboplatin intravenously during 18 weeks. Filgrastim (Neupogen) will be given prophylactically on day 5. An additional dose will be given on day 6 in case of severe neutropenia during the course of the trial.
16183067|NCT01523678|Drug|Carboplatin|All subjects will receive standard treatment with paclitaxel followed by carboplatin intravenously during 18 weeks. Filgrastim (Neupogen) will be given prophylactically on day 5. An additional dose will be given on day 6 in case of severe neutropenia during the course of the trial.
16183068|NCT01523639|Drug|Metformin/Placebo|"The starting dose of Metformin/Placebo is 500 mg p.o. twice daily for 7 days (daily dose 1000 mg p.o.). Dose will be increased to 1000 mg p.o. twice daily at day 8 (daily dose 2000 mg p.o.) unless no toxicity ≥ 2 due to IMP occurs.
~Duration of treatment: 24 weeks"
16183069|NCT01523626|Other|Total body Computed Tomography.|"The CT protocol for the intervention group consists of a two-step whole-body acquisition (from vertex to pubic symphysis) starting with Head and Neck Non Enhanced CT (NECT) with arms alongside the body.
~The preferred technique for the second complementary scan is a split-bolus intravenous contrast directly after repositioning of the arms alongside the head, and this second scan covers thorax, abdomen and pelvis. Participating centers however are free to choose their own technique as long as intravenous contrast is given for the chest and abdominal part of the TBCT."
16183070|NCT01523626|Other|Conventional imaging and selective CT scanning.|"The control group will be evaluated according to a conventional trauma protocol with X-rays (of the chest and pelvis), ultrasonography (Focused Assessment with Sonography for Trauma (FAST)) and selective CT scanning.
~Indications for the selective CT scanning are pre-defined and based on the combined local protocols of the participating centers."
16183071|NCT01523613|Device|Chemfil ROCK Glassionomer restoration|High-viscous glassionomer restoration of Chemfil ROCK used as posterior dental filling material.
16183072|NCT01523613|Device|Fuji IX GP Extra Glassionomer restoration|High-viscous glassionomer restoration of Fuji IX GP Extra used as posterior dental filling material.
16183104|NCT01523327|Other|measuring protein creatinin ratio,serum uric acid|"A non-deproteinized Jaffe reaction is employed to measure creatinine and urinary protein measured by an automated colorimetric assay using pyrogallol red and sodium molybdate.
~Measuring of serum uric acid by(2,4,6-tribromo-3-hydroxybenzoic acid)TBHBA by uricase method."
16183345|NCT01521559|Drug|Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)|
16183073|NCT01523600|Behavioral|Whole body vibration training|The intervention comprises a 10-week individually supervised, progressive WBV training done twice a week on a side-alternating device with simultaneous body transferring and slight squatting exercises. At the week one, the duration of a single training bout is 1 x 1 min, and the number of 1 min bouts is weekly increased by one until five bouts is reached. During weeks 4 - 10, the training comprises 5 x 1 min bouts with 1 min rest periods between. During weeks 1 to 3, vibration frequencies are 12 and 18 Hz, which are used alternately. Thereafter, also 26 Hz may be used instead of 18 Hz. In addition, the amplitude of vibration is increased progressively according to a specified protocol. A detailed training diary is kept.
16183074|NCT01523600|Behavioral|Wellness group|The intervention comprises a 10-week supervised group training done once a week with the focus on stretching and flexibility exercises done mostly in a sitting position. The duration of a single training session is 45 minutes. A training diary is kept.
16183075|NCT01523587|Drug|afatinib|Afatinib taken once daily, continuously until disease progression or unacceptable toxicity.
16183076|NCT01523587|Drug|erlotinib|erlotinib taken once daily
16183077|NCT01523574|Drug|Vitamin E|Vitamin E 400mg PO orally
16183078|NCT01523574|Drug|Placebo|Placebo, given orally
16183079|NCT01523561|Behavioral|dance group|"The dance intervention took place twice weekly for a period of 1 year under the guidance of two dance class teachers. The duration of the class was 75 min. and the dance training was always carried out to popular music. The dance choreography was adjusted to the level of the participants' skills in order to make them feel successful in their exercise. During the intervention year, the theme of dance styles varied from hip hop, jazz and contemporary dance. African dance was used in the warm up section. The dance class always ended with a relaxation. The dance intervention had a focus on emphasizing the participants' resources and creates a feeling of affinity. Listening to signals from the body, reducing focus on the performance and become part of the movement was encouraged."
16183080|NCT01523548|Drug|Carbon Monoxide|150 ppm x 3 hours once weekly (week 1) 150 ppm x 3 hours twice weekly (week 2) 150 ppm x 3 hours three times a week (week 3-16)
16183081|NCT01523535|Behavioral|repeated cycles of short sleep|- 3 nights of 4 hours of sleep followed by a single recovery night of 8 hours; repeated for 4 cycles
16183082|NCT01523522|Other|Myoblast injection|Autologous myoblast injection in the anal sphincter
16183083|NCT01523522|Procedure|saline solution injection|saline solution injection in anal sphincter
16183084|NCT01523509|Device|Radiographic contrast agent. Sodium Iodide.|Application of Sodium Iodide contrast topically to tooth immediately followed by radiograph.
16183085|NCT01523496|Drug|Vitamin D control dose|18,000 IU per month
16183086|NCT01523496|Drug|Vitamin D supplementation-|60,000 IU per month(medium dose) or 120,000 IU/month(high dose)
16183087|NCT01523483|Drug|Progesterone|Two micronized progesterone capsules (Utrogestan® 200 mg, i.e. 400 mg of micronized progesterone in sunflower oil) placed into the posterior vaginal fornix once daily for up to 36+6 weeks of gestation.
16183088|NCT01523483|Drug|placebo vaginal capsules|Two placebo capsules placed (soy lecithin and sunflower oil) into the posterior vaginal fornix once daily for up to 36+6 weeks of gestation.
16183089|NCT01523470|Device|BIPAP Synchrony|BIPAP Synchrony is a machine for non-invasive ventilation for acute hypercapnic respiratory failure in chronic obstructive airway disease exacerbation. It is a temporary measure. It is proven to be effective and reduce mortality and intubation in COAD exacerbation. However, the method of withdrawal of the machine remained controversial.
16183090|NCT01523457|Drug|Folfirinox|"Oxaliplatin 85 mg/m2 IV infused over two hours, followed by
~Leucovorin 400 mg/m2 IV over two hours
~Irinotecan 135 mg/m2 IV over 90 minutes (concurrent with leucovorin during the last 90 min of the leucovorin infusion)
~5-FU 300mg/m2 IV bolus, then 2400 mg/m2 continuous IV infusion over 46 hours
~FOLFIRINOX is a chemotherapy regimen. It is made up of the following four drugs:
~FOL - folinic acid (leucovorin), a vitamin B derivative that modulates/potentiates/reduces the side effects of fluorouracil; F - fluorouracil (5-FU), a pyrimidine analog and antimetabolite which incorporates into the DNA molecule and stops DNA synthesis; IRIN - irinotecan (Camptosar), a topoisomerase inhibitor, which prevents DNA from uncoiling and duplicating; and OX - oxaliplatin (Eloxatin), a platinum-based antineoplastic agent, which inhibits DNA repair and/or DNA synthesis."
16183091|NCT01523444|Behavioral|computer-assisted Screening & Brief Advice|"The computer-facilitated screening and brief advice (cSBA) intervention is a self-administered, computer-facilitated screening that asks about lifetime and past-12-month use of substances followed by scientific information about how substance use affects health and true-life stories illustrating the health risks of substance use. The cSBA program prints out a Report Form with the screening results, risk level, and talking points designed to prompt a 2 to 3-minute provider/teen conversation about the health effects of substance use, which recommends abstinence."
16183092|NCT01523444|Behavioral|computer-assisted Screening & Brief Advice Plus|The cSBA+ intervention contains cSBA intervention elements plus the delivery of a brief, two-session motivational enhancement therapy (MET) intervention to be delivered a Behavioral Health Counselor (BHC) at the clinic immediately after meeting with the primary care provider. In the first session of this intervention, youth should be encouraged to think about: (1) The role alcohol and drugs play in his/her life; (2) His/her personal goals for changing alcohol and drug use; (3) Strategies for reaching and maintaining goals. The goal at the end of the session is positive movement in the direction of abstinence or change. The aim of the second session is reinforcement of goals set forth in the prior meeting with the BHC.
16183093|NCT01523431|Drug|Irinotecan Injection [Camptosar]|CPT-11 will be administered according to UGT1A1 genotypes. Patients with UGT1A1 *1/*1 or heterozygous UGT1A1*1/*28 or *1/*6 will receive standard dose of CPT-11. Patients with homozygous UGT1A1*28/*28, *6/*6 or *28/*6, will be randomized in a 1:1 ratio to receive standard dose of CPT-11 or 50% reduced dose of CPT-11.
16183094|NCT01523431|Drug|5-fluorouracil|The 5-FU dosage will remain the standard.
16183095|NCT01523431|Drug|Leucovorin|The LV dosage will remain the standard.
16183096|NCT01523418|Drug|Rivaroxaban (Xarelto, BAY59-7939)|The treatment with Xarelto 10mg tablets should comply with the recommendations. Rivaroxaban 10mg OD, 6-10 hours post-op, provided hemostasis has been achieved, for a period of 2 weeks (TKR) & 5 weeks (THR)
16183097|NCT01523392|Drug|Ticagrelor|Min - 90mg/Max - 180mg tablets (loading dose)
16183098|NCT01523392|Drug|Clopidogrel|75mg (once daily)/Max - 600mg tablets (loading dose)
16183099|NCT01523379|Drug|Parecoxib|90mg Parecoxib i.v. two times a day, two days in a row
16183105|NCT01523314|Drug|dexamethasone - Cyclodextrin eye drops|The study eye will receive the dexamethasone NP eye drops 3 times a day for 3 months. The subject will be handed an eye drop bottle at each monthly visit for self administration of the eye drops. Each eye drop container is to be marked with a date when first opened and discarded after 1 week (unless it contains a preservative).
16183106|NCT01523314|Other|intravitreal Avastin injection +/- macular laser|The study eye will receive standard laser and intravitreal injections of Avastin for 3 months. Complete eye examination will be performed prior to drug administration.
16183107|NCT01523301|Drug|Rotigotine|"Transdermal Patch
~Content:
~2 mg /24 h (10 cm^2), 4 mg /24 h (20 cm^2), 6 mg /24 h (30 cm^2), 8 mg /24 h (40 cm^2)
~For early-stage Parkinson's disease, Subjects received Rotigotine patches in escalating weekly dose (starting with daily doses 2 mg/24 h to 8 mg/24 h) for a maximum 4-week Titration Period, then 8 week Maintenance period
~For advanced-stage Parkinson's disease, Subjects received Rotigotine patches in escalating weekly dose (starting with daily doses 4 mg/24 h to 16 mg/24 h) for a maximum 7-week Titration Period, then 8 week Maintenance period"
16183108|NCT01523301|Drug|Placebo|"Transdermal Patch
~Size:
~10 cm^2, 20 cm^2, 30 cm^2, 40 cm^2
~Subjects randomized to placebo received matching placebo patches"
16183109|NCT01523275|Drug|Mitomycin -C|Topical mitomycin-C at a dosage of 0.4mg/ml will be applied to cottonoid pledgets and placed into the radial incisions for 3 minutes.
16183110|NCT01523275|Other|Saline application|Isotonic saline will be applied to cottonoid pledgets and placed into the patient's radial incisions for 3 minutes as the placebo intervention.
16183111|NCT01523262|Procedure|preconditioning|peripheral preconditioning induced by brief, intermittent constriction of blood supply to an arm
16183112|NCT01523262|Procedure|Normal surgery, with sham intervention without inflating arm cuff|
16183113|NCT01523249|Device|Lumbar 3D ultrasound scanning and palpation (Ultrasonix )|Paramedian ultrasound scanning of L2-3 and L3-4 lumbar interspaces to visualize ligamentum flavum. Palpation of the same intervertebral spaces to identify spine midline and needle insertion point.
16183114|NCT01523236|Drug|Mometasone furoate|50 mcg/actuation Nasal Spray
16183115|NCT01523236|Drug|Nasonex®|50 mcg/actuation Nasal Spray
16183116|NCT01523236|Drug|Placebo|Nasal Spray
16183117|NCT01523223|Biological|therapeutic allogeneic lymphocytes|Undergo CD8 memory T-cell infusion
16183118|NCT01523210|Other|physiotherapy|thirty minutes passive flexion and extension of the elbow joint by a physiotherapist
16183119|NCT01523197|Device|BiPAP ventilation, auto-trilevel ventilation|Noninvasive ventilation including fixed BiPAP ventilation and auto-trilevel ventilation. Using the same IPAP, treatment include one night with BiPAP ventilation mode 1, one night with BiPAP ventilation mode 2 and one night with auto-trilevel ventilation mode. Each treatment last 8 hours for each night.
16183120|NCT01523184|Drug|Placebo Capsule|This is the placebo capsule
16183121|NCT01523184|Drug|YKP10811 Drug Product Capsule|The drug product, YKP10811, 10 mg under investigation
16183122|NCT01523184|Drug|YKP10811 Drug Product Capsule|The drug product, YKP10811, 20 mg under investigation
16183123|NCT01523184|Drug|YKP10811 Drug Product Capsule|The drug product, YKP10811, 30 mg under investigation
16183124|NCT01523171|Drug|SAR302503|"Pharmaceutical form:capsule
~Route of administration: oral"
16183125|NCT01523158|Biological|Allergovit grass or birch|subcutaneous injection of immunotherapy once weekly for 7 weeks prior to birch pollen season.
16183126|NCT01523145|Behavioral|Rehabilitation|Integrated Rehabilitation consisting of exercise training (minimum 3 times a week for a total of twelve weeks) and psychoeducational care (4 sessions over 6 months)
16183127|NCT01523145|Other|Control Group|usual follow-up Standard follow-up at the participating heart center
16183128|NCT01523119|Drug|Ondansetron|Orally Disintegrating Tablets 8 mg
16183129|NCT01523106|Drug|L-carnitine|dietary supplement
16183130|NCT01523106|Other|Placebo|Patients will receive placebo, which will be manufactured by the same supplier as L-carnitine and appears identical. Patients will take an equal number of pills (8 pills/day).
16183131|NCT01523093|Drug|Ondansetron|Orally Disintegrating Tablets 8mg
16183132|NCT01523080|Drug|Acetaminophen|Extended release Gel tabs 650 mg
16183133|NCT01523067|Drug|Vasomera (PB1046)|Single dose of Vasomera
16183134|NCT01523067|Drug|0.9% Sodium Chloride|Placebo injection
16183135|NCT01523054|Drug|Metoprolol- Toprol XL|Extended release tablet, 200mg once daily for 4 days
16183136|NCT01523054|Drug|Metoprolol- Lopressor|Immediate release tablet, Day 1 50 mg four times daily, Day 2, 3 and 4 100 mg twice daily
16183137|NCT01523041|Drug|biphasic insulin aspart 70|A single dose administrated subcutaneously (s.c., under the skin)
16183138|NCT01523041|Drug|biphasic insulin aspart 70|A single dose administrated subcutaneously (s.c., under the skin)
16183139|NCT01523041|Drug|biphasic insulin aspart 50|A single dose administrated subcutaneously (s.c., under the skin)
16183140|NCT01523028|Other|Soluble Coffee|"Amounts of chlorogenic acids will be normalized to body weight (3.1 mg CA / kg BW). Coffee will be reconstituted in 200 mL hot water and consumed 3 times in a row (min 1-week interval), alone or with a breakfast:
~200 mL coffee or
~200 mL coffee + 2 bread rolls + honey
~200 mL coffee + 1 bread roll + peanut butter"
16183141|NCT01523015|Other|preoperative chemo- and chemoradiotherapy|2 cycles of triple regimen chemotherapy consisting of docetaxel (75mg/m2 iv infusion), oxaliplatin (130mg/m2 iv infusion) and 5-fluorouracil (750mg/m2 iv infusion followed by fractionated irradiation (total dose 45Gy in 25 fractions of 1,8Gy) combined with chemotherapy consisting of 3 cycles of 1-day chemotherapy with docetaxel (50mg/m2 iv infusion) and oxaliplatin (85mg/m2 iv infusion
16183142|NCT01523015|Procedure|Surgical resection|The extent of surgery will be associated with the topographic type of carcinoma of the esophagogastric junction: type I - subtotal esophagectomy with superior gastric resection, splenectomy and two-field mediastinal lymph node dissection; type II and III - total gastrectomy with distal esophagectomy, splenectomy and D2 with mediastinal inferior lymph node dissection.
16183171|NCT01522820|Other|Pharmacological Study|Correlative studies
16183172|NCT01522820|Drug|Sirolimus|Given PO or PEG
16183173|NCT01522807|Drug|PF-05190457|100 mg single oral dose of PF-05190457 is administered as a suspension in the fasted state
16183174|NCT01522807|Drug|PF-05190457|100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fasted state
16183143|NCT01523002|Drug|Metoprolol and Pyronaridine : artesunate|"On Day 1, subjects will receive a single oral 100 mg dose of metoprolol tartrate. On Day 8 and Day 9, subjects will receive a once daily oral dose of Pyramax as follows:
~55 - < 65 kg: 3 tablets (180:60 mg pyronaridine:artesunate)
~≥ 65 kg: 4 tablets (180:60 mg pyronaridine:artesunate)
~On Day 10, a 100 mg dose of metoprolol will be coadministered with Pyramax at the above dose.
~On Days 98 - 100, subjects will receive Pyramax once daily at the same dose described above."
16183144|NCT01523002|Drug|pyronaridine:artesunate|"In the first period, subjects will receive 3 days of Pyramax as follows:
~55 - < 65 kg: 3 tablets (180:60 mg pyronaridine:artesunate)
~≥ 65 kg: 4 tablets (180:60 mg pyronaridine:artesunate) followed by a 57 day follow-up period. In the second period, subjects will receive 3 days of Pyramax at the dose described above."
16183145|NCT01522989|Drug|PD-0332991|"Stage 1:
~PD-0332991 daily Days 1-7 in escalating doses 5-FU 400 mg/m2 Day 8 Leucovorin 400 mg/M2 Day 8 5-FU continuous Infusion over 46 hours, 2400 mg/M2 Days 8-10
~Stage 2: 3 cohorts of subjects each will be treated with the dose of PD-0332991 determined to be the recommended Phase 2 dose in Stage 1 of the study with 5-FU at the doses above but on different schedules:
~Cohort 1: 5-FU bolus on Day 7 and infusion Days 7-9 Cohort 2: 5-FU bolus Day 9 and infusion Days 9-11 Cohort 3: 5-FU bolus Day 1 and infusion Days 1-3
~In Stage 3, PD-0332991 and 5-FU will be given at the doses and schedule determined in Stages 1 and 2 of this study with the addition of oxaliplatin 85 mg/m2 given on the same day as the 5-FU bolus."
16183146|NCT01522989|Drug|5-FU|"Stage 1:
~PD-0332991 daily Days 1-7 in escalating doses 5-FU 400 mg/m2 Day 8 Leucovorin 400 mg/M2 Day 8 5-FU continuous Infusion over 46 hours, 2400 mg/M2 Days 8-10
~Stage 2: 3 cohorts of subjects each will be treated with the dose of PD-0332991 determined to be the recommended Phase 2 dose in Stage 1 of the study with 5-FU at the doses above but on different schedules:
~Cohort 1: 5-FU bolus on Day 7 and infusion Days 7-9 Cohort 2: 5-FU bolus Day 9 and infusion Days 9-11 Cohort 3: 5-FU bolus Day 1 and infusion Days 1-3
~In Stage 3, PD-0332991 and 5-FU will be given at the doses and schedule determined in Stages 1 and 2 of this study with the addition of oxaliplatin 85 mg/m2 given on the same day as the 5-FU bolus."
16183147|NCT01522989|Drug|Oxaliplatin|"Stage 1:
~PD-0332991 daily Days 1-7 in escalating doses 5-FU 400 mg/m2 Day 8 Leucovorin 400 mg/M2 Day 8 5-FU continuous Infusion over 46 hours, 2400 mg/M2 Days 8-10
~Stage 2: 3 cohorts of subjects each will be treated with the dose of PD-0332991 determined to be the recommended Phase 2 dose in Stage 1 of the study with 5-FU at the doses above but on different schedules:
~Cohort 1: 5-FU bolus on Day 7 and infusion Days 7-9 Cohort 2: 5-FU bolus Day 9 and infusion Days 9-11 Cohort 3: 5-FU bolus Day 1 and infusion Days 1-3
~In Stage 3, PD-0332991 and 5-FU will be given at the doses and schedule determined in Stages 1 and 2 of this study with the addition of oxaliplatin 85 mg/m2 given on the same day as the 5-FU bolus."
16183148|NCT01522976|Drug|Azacitidine|Given SC or IV
16183149|NCT01522976|Other|Laboratory Biomarker Analysis|Correlative studies
16183150|NCT01522976|Drug|Lenalidomide|Given PO
16183151|NCT01522976|Drug|Vorinostat|Given PO
16183152|NCT01522963|Drug|Nicotine lozenge|A single dose of nicotine lozenge will be given at various timepoints relative to completion of a somewhat stressful task
16183153|NCT01522950|Drug|Nebivolol|5 mg daily or 10 mg daily
16183154|NCT01522950|Drug|atenolol|25 mg daily or 50 mg daily
16183155|NCT01522950|Drug|placebo|one tablet daily
16183156|NCT01522937|Radiation|individualized Stereotactic Body Radiation Therapy (SBRT)|The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment.
16183157|NCT01522924|Other|Counseling practice sessions|Dental students will complete the first questionnaire before a tobacco cessation lecture and the second questionnaire after the lecture, counseling practice sessions using standardized patients and a debriefing session.
16183158|NCT01522911|Device|WATCHMAN LAA system (Percutaneous left atrial appendage closure)|The WATCHMAN LAA system (Altritech Inc., Plymouth, MN),Percutaneous occlusion systems have been developed as an alternative to anticoagulation for stroke prevention. Briefly, transseptal puncture is performed to gain access to the left atrial appendage (LAA). Thereafter LAA angiography is performed. After an optimal device size is chosen based on LAA measurements by fluoro and echocardiography the occluder is implanted into the orifice of the left atrial appendage under fluoroscopy and TEE-guidance. The size of the device is chosen to be 10% to 20% larger than diameter of the LAA ostium to have stable positioning of the device. Every procedure is performed under local anaesthesia. Heparin is given during implantation procedure to achieve an activated clotting time of at least 250.
16183159|NCT01522898|Procedure|AV nodal ablation|Percutaneous catheter ablation of the AV node.
16183160|NCT01522898|Drug|Medical Ventricular Rate Control|Ventricular Rate Control with target ventricular rate of 90 beats per minute.
16183161|NCT01522885|Device|KatGuide versus conventional method (forceps)|According to randomization Chest tubes are placed in the pleural cavity by using the KatGuide device.
16183162|NCT01522885|Procedure|Chest tube insertion|The chest tube is placed in the pleural cavity by using a forceps (conventional method) or KatGuide
16183163|NCT01522872|Drug|TH-302|
16183164|NCT01522872|Drug|TH-302 and Dexamethasone|
16183165|NCT01522872|Drug|TH-302 Dose Escalation and Dexamethasone in Combination with Bortezomib|
16183166|NCT01522872|Drug|TH-302 Dose Escalation and Dexamethasone in Combination with Pomalidomide|
16183167|NCT01522859|Device|Telehealth monitoring system (Honni Med)|The system is uploaded with personal information including: monitoring start time; clinical observations (blood pressure, heart rate, oxygen saturations); and questions relating to symptoms. The patient is instructed on use and observed monitoring. The patient is monitored daily for a period of six months. The monitoring session lasts approximately 10 minutes during which the patient attaches a finger probe and blood pressure cuff and responds 'yes' or 'no' to the set questions. Daily data is transmitted via a phone line to a secure server to be downloaded and reviewed by a Telehealth nurse.If one or more of the clinical observations is outside normal limits the appropriate healthcare intervention is utilised.
16183168|NCT01522846|Drug|Heparin|Heparinized flush solution contained heparin concentration of 2 unit/ml and continuous flow of the flush solution was 5 ml/h at 300 mmHg.
16183169|NCT01522820|Biological|DEC-205/NY-ESO-1 Fusion Protein CDX-1401|Given intranodally
16183170|NCT01522820|Other|Laboratory Biomarker Analysis|Correlative studies
16183176|NCT01522807|Drug|PF-05190457|100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fed state
16183177|NCT01522807|Drug|PF-05190457|100 mg single oral dose of PF-05190457 is administered as a suspension in the fasted state
16183178|NCT01522807|Drug|PF-05190457|100 mg single oral dose of PF-05190457 is administered as a short-duration osmotic capsule in the fasted state
16183179|NCT01522807|Drug|PF-05190457|100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fasted state
16183180|NCT01522807|Drug|PF-05190457|100 mg single oral dose of PF-05190457 is administered as a long-duration osmotic capsule in the fed state
16183181|NCT01522794|Drug|NOX-H94|single i.v. infusion
16183182|NCT01522794|Drug|Placebo solution|single i.v. infusion
16183183|NCT01522768|Drug|Afatinib and Paclitaxel|All patients receiving therapy on trial with afatinib and trastuzumab will continue on afatinib and trastuzumab until disease progression or intolerable toxicity. All additional patients will be enrolled on afatinib and paclitaxel. Patients will be treated with afatinib and paclitaxel combination. Patients will receive oral afatinib 40 mg daily plus paclitaxel 80 mg/m^2 intravenously on day 1, 8, and 15 of a 28-day cycle.
16183184|NCT01522755|Device|Pacing system implant with the CapsureFix MRI pacing lead model 5086|Pacing system implant with the CapsureFix MRI pacing lead model 5086
16183185|NCT01522729|Drug|Fentanyl|Single-dose of intrathecal fentanyl [25ug] Duration of fentanyl : 3.5 hours
16183186|NCT01522729|Drug|Placebo comparator|placebo [NaCl]
16183187|NCT01522716|Biological|Mesenchymal stromal cells|Allogenous mesenchymal stromal cells, to be injected intravenously at a dose of 1-2 million/kg at a frequency of once a month (frequency may be changed during the study if deemed appropriate by investigators) for 6-9 months.
16183188|NCT01522703|Drug|Broccoli Sprouts|100g of either broccoli or alfalfa sprouts will be eaten daily in a sandwich or wrap form.
16183189|NCT01522703|Drug|Placebo|Alfalfa Sprouts
16183190|NCT01522690|Other|Different walk tests with an accelerometer device|Subjects will performed three walk tests of 50 meter at different speeds, a six minute walk test, a walking test of 30 seconds then a test to measure the maximum force of extension and knee flexion on each leg. The walk tests will be performed with the accelerometer device (Locometrix) worn in a belt
16183191|NCT01522677|Drug|PDT with 5-ALA radiosensitization|Patients receive neoadjuvant PDT with radiosensitizing 5-ALA 4 days prior to surgery for colon cancer.
16183192|NCT01522664|Drug|DEDN6526A|Multiple ascending doses
16183193|NCT01522651|Drug|Ranolazine|Tablets administered orally twice daily.
16183194|NCT01522651|Drug|Dronedarone|Capsule administered orally twice daily
16183195|NCT01522651|Drug|Ranolazine placebo|Tablets administered orally twice daily.
16183196|NCT01522651|Drug|Dronedarone placebo|Capsules administered orally twice daily
16183197|NCT01522625|Drug|tenofovir disoproxil fumarate 300mg per day|tenofovir disoproxil fumarate 300mg per day for 3 years
16183198|NCT01522625|Drug|Placebo|Placebo, identical to TDF in appearance, once daily for 3years
16183199|NCT01522612|Drug|Cetuximab|500 mg/m2 on day 1, Every 14 days Intravenously
16183200|NCT01522612|Drug|5-fluorouracil|Every 2 weeks, 400 mg/m2 on day 1; 2400 mg/m2 from day 1 to day 3, intravenously
16183201|NCT01522612|Drug|leucovorin|Every 2 weeks, Racemic leucovorin 200 mg/m2 or l-leucovorin 100 mg/m2 on day 1, intravenously
16183202|NCT01522599|Other|ARDS-Net Strategy|Treatment according to the ARDS-Net protocol (The Acute Respiratory Distress Syndrome Network N Engl J Med 2000; 342:1301-1308May 4, 2000)
16183203|NCT01522599|Other|ECCO2-R|Ventilation with Tidal Volume of 4 ml/kg PBW and low flow CO2 removal
16183204|NCT01522586|Drug|DWP09031|DWP09031 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing
16183205|NCT01522586|Drug|Placebo|placebo comparator 50mg/100mg/400mg/200mg/800mg/1200mg/1600mg/2000mg single dosing
16183206|NCT01522573|Procedure|EUS guided ERCP|Endoscopic ultrasound guided (EUS) endoscopic retrograde cholangiopancreatography (ERCP)
16183207|NCT01522560|Other|Feedback group|"Besides the standard evaluation at the end of the rotation, in both groups, residents will receive every week a Multiscore Feedback (MSF) evaluation from the faculty, the patients' parent, and the coworker. Also, for every resident a baseline self assessment will be applied at the beginning and at the end of the rotation.
~This group is going to have a 'coaching meeting' every month with the Chairman of Department of Pediatric Anesthesia to identify strengths and weaknesses and create strategies for improvement, based on the Multiscore Feedback (MSF)."
16183208|NCT01522560|Other|Control group|Besides the standard evaluation at the end of the rotation, in both groups, residents will receive every week a Multiscore Feedback (MSF) evaluation from the faculty, the patients' parent, and the coworker. Also, for every resident a baseline self assessment will be applied at the beginning and at the end of the rotation.
16183209|NCT01522547|Drug|pomalidomide|Pomalidomide orally for 84 days daily in doses ranging from 0.5 mg to 4.0 mg
16183210|NCT01522534|Drug|Mepivacaine|mepivacaine 1% 20 ml corresponding to 200 mg
16183211|NCT01522534|Drug|Morphine|Morphine alone with a placebo nerve block
16183212|NCT01522521|Drug|AK156|zoledronic acid (i.v.)/year + daily calcium and vitamin D for 2 years
16183213|NCT01522521|Drug|Placebo|placebo (i.v.)/year + daily calcium and vitamin D for 2 years
16183214|NCT01522508|Procedure|tetanic stimulation|as test stimulus a painful tetanic stimulation is used
16183215|NCT01522495|Device|SPY Imaging, ICG dye (0.2 - 0.5 mg/kg)|Intravenous(1X) in conjunction with SPY Imaging (1 arm)
16183216|NCT01522495|Device|SPY Imaging|SPY Imaging to assess tissue perfusion
16183217|NCT01522482|Dietary Supplement|High saturated fat meal|Volunteers consumed a single test meal breakfast containing 53 g of fat, of which 50 g was substituted for saturated fats.
16183218|NCT01522482|Dietary Supplement|Saturated fatty acids and fish oil meal|"Volunteers consumed a single test meal breakfast containing 53 g of fat, of which 50 g was substituted for saturated fats and fish oil.
~The dose of fish oils was equivalent to two portions of oily fish."
16183219|NCT01522482|Dietary Supplement|High unsaturated fat meal|Volunteers consumed a single test meal breakfast containing 53 g of fat, of which 50 g was substituted for unsaturated fats. It provided a fatty acid profile representative of a typical UK diet.
16183343|NCT01521572|Drug|Salbutamol sulphate|bronchodilator test, beta2-agonist, short-acting, six hours duration, 400 micrograms.
16183220|NCT01522469|Drug|Crenolanib Besylate (CP-868,596-26)|Subjects will take crenolanib 200mg/m2/day divided in three doses daily (preferably every eight hours), taken orally at least 30 minutes pre or post meal until disease progression, death, or the patient discontinues treatment for adverse events, investigator's judgment, or other reasons. Patients who are able to proceed to allogeneic stem cell transplant will be able to resume crenolanib therapy post-transplant in an attempt to maintain remission.
16183221|NCT01522456|Drug|Epiduo Gel|Once-daily application of fixed dose of adapalene 0.1% and benzoyl peroxide 2.5% in an aqueous based gel.
16183222|NCT01522456|Drug|Retin-A Micro Microsphere 0.1%|Once-daily application of tretinoin gel, 0.1% by weight, in a formulation of porous microspheres in an aqueous gel.
16183223|NCT01522443|Drug|cabozantinib|Tablets taken orally once daily.
16183224|NCT01522443|Drug|mitoxantrone|Given by IV once every 3 weeks.
16183225|NCT01522443|Drug|prednisone|Taken twice a day orally by mouth. Commercially-obtained prednisone tablets will be over-encapsulated in order to blind identity.
16183226|NCT01522430|Procedure|Renal angiography followed by renal sympathetic denervation|Radiofrequency catheter based therapy for renal denervation: Symplicity catheter will be advanced into the renal artery and connected to a radiofrequency generator. As previously described, four-to-six discrete, low-power radio frequency treatments will be applied along the length of both main renal arteries. At least four radiofrequency applications will be delivered in each renal artery, unless this is not feasible for anatomical reasons.
16183227|NCT01522430|Procedure|Renal angiography alone|Procedure will start with a local anesthesia of the femoral site to allow the placement of a 4-Fr sheath in the femoral artery, which allows a minimal risk of bleeding to the patient. Using JR-4 or similar diagnostic catheter, a selective renal angiography will be realized.
16183228|NCT01522417|Drug|Short Tirofiban|25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion during a PCI plus 1 to 2 hours post-PCI.
16183229|NCT01522417|Drug|Eptifibatide|180 mcg/kg bolus followed by a 2.0 mcg/kg/min infusion for 12 to 18 hours, with a second 180 mcg/kg bolus 10 min after the first.
16183230|NCT01522417|Drug|Long Tirofiban|25 mcg/kg i.v. bolus followed by a 0.15 mcg/kg/min i.v. infusion for 12 to 18 hours post-PCI.
16183231|NCT01522404|Drug|Atomoxetine|Subjects in this intervention will receive Atomoxetine up to 29 weeks, crossover, dose escalating (up to a maximum dose of 100 mg per day) of oral atomoxetine
16183232|NCT01522404|Drug|Placebo|Subjects in this intervention will receive inactive compound up to weeks 29 and will cross over to the other group
16183233|NCT01522391|Drug|DPK-060 1% ointment|DPK-060 1% ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2
16183234|NCT01522391|Drug|Placebo for DPK-060 ointment|Placebo for DPK-060 ointment applied to the skin, two applications per day using approximately 3 mg ointment per cm2
16183235|NCT01522378|Drug|123 iodine metaiodobenzylguanidine|10 millicurie (mCi) (370 MBq)
16183236|NCT01522365|Device|Abutment-supported XiVE CAD/CAM bridge|One side will be provided with a XiVE CAD/CAM bridge placed directly on an abutment
16183237|NCT01522365|Device|Implant-supported XiVE CAD/CAM bridge|One side will be provided with a XiVE CAD/CAM bridge fixed directly on the implant
16183238|NCT01522352|Procedure|Aortic valve replacement by bioprosthesis|Comparison of short and mid-term hemodynamic performance between three types of stented pericardial aortic valves: Trifecta aortic valve (St. Jude Medical), Mitroflow aortic valve (Sorin Group), Magna Ease (Edwards Lifesciences)
16183239|NCT01522339|Device|GE OPTIMA MR430s with HDX/GE Electronics|MRI scan(s) for no longer than 60 minutes
16183240|NCT01522326|Drug|Ibuprofen|Ibuprofen 400mg tablet. Take one dose by mouth.
16183241|NCT01522326|Drug|Metoclopramide|Metoclopramide 10mg tablet. Take one tablet by mouth.
16183242|NCT01522300|Other|Evaluation of the Tomosynthesis|An exam by tomosynthesis will be realised at the inclusion of the patient in the study.
16183243|NCT01522300|Other|Avaluation of a medical device: the tomosynthesis|An exam by tomosynthesis will be realised at the inclusion of the patient in the study
16183244|NCT01522287|Behavioral|Computer-Assisted Cognitive Behavior Therapy (BT STEPS)|BT STEPS is a computer-assisted self help treatment for OCD. Clients work through the program at their own pace.
16183245|NCT01522274|Behavioral|Moderate intensity exercise|Brisk walking on a treadmill for 56 minutes 3x per week.
16183246|NCT01522274|Behavioral|Health education|Videos
16183247|NCT01522261|Other|Mechanical Bowel Prep|Patients randomized to MBP will complete procedure per standard instructions.
16183248|NCT01522261|Other|No Mechanical Bowel Prep|Patient randomized to fleets enemas only prior to surgery
16183249|NCT01522248|Biological|Trivalent Inactivated Influenza vaccine|0.5 ml IM once only
16183250|NCT01522235|Drug|Double blinded IVIg|Participants will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment IVIg, at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.
16183251|NCT01522235|Other|Double blinded Placebo|Participants will receive placebo (5% albumin) at 2.0 gm/kg over 2-4 consecutive days. A maintenance treatment with placebo (5% albumin) at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later. All participants will proceed to the single blind Second Observation Period.
16183252|NCT01522235|Other|Single Blinded IVIg|This is the single blind Second Observation Period. All participants will receive study treatment with IVIg, at 2.0 gm/kg over 2-4 consecutive days. A maintenance study treatment at 1.0 gm/kg, over 1-2 consecutive days will occur three weeks later.
16183253|NCT01522222|Procedure|continuous, mechanical ventilatory support|Those in the treatment group will receive ventilation, intermittent positive pressure ventilation, while their heart is arrested. The subjects will have their lungs ventilated six times per minute with a tidal volume equal to 7-10 milliliters per kilogram. This range, when combined with a consistent PEEP of 5cm of water pressure, will allow for the peak inspiratory pressure to be maintained at or below 40cm of water pressure. In addition, the FIO2 will remain consistent at the same level that was needed to maintain the pulse oximetry at 94% as well as the end-tidal CO2 at 35mmHg.
16183254|NCT01522209|Procedure|Liver Surgery|R0 Resection of Liver Metastases after Planning with preoperative imaging data and comparison with intraoperative contrast enhanced ultrasound
16183255|NCT01522209|Device|Contrast Enhanced Ultrasound|The contrast enhanced Ultrasound imaging is performed before and during the operation using Sonovue contrast agent (2.5ml iv preop, 4.5ml iv intraop)
16183256|NCT01522209|Radiation|CT Scan (standard)|A staging CT of the liver/abdomen with the minimal possible dosage for aquiring sufficent triphasic data in a 64-line helical scan
16183257|NCT01522209|Radiation|Primovist MRI (3 Tesla)|an MRI scan of the liver with Primovist contrast agent including late phase as addition to the preop staging according to the protocol
16183258|NCT01522196|Drug|Varespladib|48 hour continuous infusion delivered intravenously (IV)at a rate of 110µg/kg/hr.
16183259|NCT01522196|Other|Placebo (Normal Saline)|48 hour continuous infusion delivered intravenously (IV)at a rate of 110µg/kg/hr.
16183260|NCT01522157|Dietary Supplement|Low-fat Diet|Low-fat Diet is provided for a breakfast and a lunch.
16183261|NCT01522157|Dietary Supplement|Low-carbohydrate Diet|Low-carbohydrate Diet is provided for a breakfast and a lunch.
16183262|NCT01522157|Dietary Supplement|Mediterranean Diet|Mediterranean Diet is provided for a breakfast and a lunch.
16183263|NCT01522144|Behavioral|Computerized Decision support|Using a clustered randomized method, computerized decision support, embedded in the electronic health record, was offered to selected primary care practices and outcomes of asthma care were compared to those practices without the computerized decision support.
16183264|NCT01522131|Procedure|bioresorbable membrane alonewill be used for regeneration of the periodontium(control)|bioresorbable membrane with laser will be used for regeneration of the periodontium(test)
16183265|NCT01522118|Device|ExAblate 2100; InSightec|"Patients with biopsy proven locally non-advanced T2 prostate cancer identified at 3T MR examination including dynamic contrast enhanced (DCE-with time to peak and mean transit time evaluation) and candidate to radical prostatectomy will undergo Magnetic Resonance guided Focused Ultrasound (MRgFUS) ablation. The procedure is carried out either under general anesthesia or spinal block.
~MR images allow correct identification of the target as well as vital structure to avoid during energy delivery. Treatment safety and efficacy is monitored in real time using MR thermometry. Adjustments of energy direction and intensity can be made according to the real time monitoring. Pre- and post-ablative MR examinations will serve to analyze differences of DCE features of the neoplastic tissue; therapy-induced alterations will also be compared to histopathology findings from whole section prostate specimens"
16183266|NCT01522105|Drug|Daptomycin|One dose of daptomycin given at an age appropriate dosage (3-24 months 6mg/kg; 2-6 years 10mg/kg; 7-11 years 8mg/kg; 12-16years 6mg/kg)
16183267|NCT01522092|Drug|escitalopram|5mg-20mg, tablet, od, 12 months
16183268|NCT01522079|Procedure|Air stacking manuever|Electrocardiogram signals were recorded for analyses of heart rate variability during air stacking in supine and sitting position
16183269|NCT01522066|Procedure|Perineural catheter|Patients in the experimental group will receive a single dose of local anesthetic though an indwelling catheter both before and after surgery.
16183270|NCT01522066|Procedure|Single-shot block|Patients in the control group will receive a single shot of local anesthetic, in standard fashion, before surgery.
16183271|NCT01522053|Procedure|Catheter-over-needle|Patients in the experimental group will receive a perineural catheter placed by the catheter-over-needle method.
16183272|NCT01522053|Procedure|Catheter-through-needle|Patients in the control group will receive a perineural catheter placed by the traditional catheter-though-needle method.
16183273|NCT01522040|Drug|Magnesium Sulfate|Continuous magnesium drip, titrated to effect until patient's symptoms improve
16183274|NCT01522040|Drug|Placebo|Simple saline drip, without active drug
16183275|NCT01522027|Procedure|Percutaneous tracheostomy|Twenty ICU patients will receive percutaneous tracheostomy via insertion of a needle/catheter connected to a nerve stimulator.
16183276|NCT01522014|Device|Secure-Fit™ arc-deposited Hydroxylapatite (HA) shell - surface ceramic and an Alumina Bearing Couple (ABC) ceramic insert and Ceramic C-taper head|
16183277|NCT01522014|Device|Secure-Fit™ arc-deposited hydroxylapatite shell, a Crossfire® insert and a Ceramic C-taper head|
16183278|NCT01522001|Behavioral|Shared Care model|"First visit at cardiac ambulatory approximately 14 days after discharge includes physician examination by cardiologist and counseling from nurse specialized in cardiac rehabilitation.
~Dietary counseling with dietician
~Exercise (1 hour, 2 timer pr week for 12 weeks)
~Smoking cessation if smoker with educated smoking cessation instructor
~Patient education and psychosocial support in 2 individual consultations and 8 group based consultations with experienced nurse
~Examination by the patient´s general practitioner 8-12 weeks after discharge."
16183279|NCT01521988|Procedure|Atrial flutter ablation|Radiofrequency ablation of Atrial flutter
16183280|NCT01521988|Procedure|Atrial flutter ablation and pulmonary vein isolation|Radiofrequency ablation of atrial flutter and pulmonary vein isolation using cryoablation
16183281|NCT01521975|Drug|Telbivudine, Adefovir dipivoxil|All patients will take Telbivudine 600 mg PO daily from baseline. Some patients will take Adefovir dipivoxil 10 mg PO daily if they meet the criteria of adding Adefovir dipivoxil.
16183282|NCT01521962|Drug|Alogliptin|Alogliptin tablets
16183283|NCT01521962|Drug|Insulin|Insulin injection
16183284|NCT01521949|Drug|Acai Juice Product|2 ounces of Acai Juice Product twice daily.
16183285|NCT01521936|Dietary Supplement|cholecalciferol|Given PO (lower dose)
16183286|NCT01521936|Other|pharmacological study|Correlative studies
16183287|NCT01521936|Dietary Supplement|cholecalciferol|Given PO (higher dose)
16183288|NCT01521936|Other|laboratory biomarker analysis|Correlative studies
16183289|NCT01521923|Biological|Certolizumab Pegol + Methotrexate (MTX)|"Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at dosage strength of 200 mg/ml.
~On a maintenance dose of 200 mg every 2 Weeks (Q2W) until Week 102. On a maintenance dose of 200 mg every 4 Weeks (Q4W) until Week 102/ Placebo (PBO) 1 syringe every 4 Weeks (Q4W).
~CZP and PBO administration to be staggered 2 Weeks apart to maintain blind.
~The MTX treatment is to remain between 15-25 mg/week."
16183290|NCT01521923|Biological|Placebo + Methotrexate (MTX)|"1 syringe of Placebo every 2 Weeks and MTX.
~The MTX treatment is to remain between 15-25 mg/week."
16183291|NCT01521910|Dietary Supplement|low protein diet|"An iso-caloric low protein diet of 0.6 g/kg/day was prescribed during the whole study duration.
~The same dietician gave nutritional advices at least every three months during the whole study period. Patients were also seen by the same doctor during each visit for the whole study period.
~Supplementation of Calcium of 500mg/day.
~Urine albumin losses >= 2 g/day wre replaced by increasing dietary protein on a gram-for-gram basis, only if the patient was compliant with the prescribed low-protein diet."
16183292|NCT01521910|Dietary Supplement|normal protein diet|"The patients pre-study diet during the whole study period
~Patients were also seen by the same doctor during each visit for the whole study period."
16183293|NCT01521897|Biological|7-valent vaccine injection|For primary immunization, three doses of Prevenar 0.5 mL should be injected subcutaneously with an interval of at least 27 days between each dose. For booster immunization, one dose of Prevenar 0.5 mL should be injected subcutaneously, at least 60 days after the 3rd dose.
16183294|NCT01521884|Other|SC anti-TNF|SC anti-TNF
16183295|NCT01521871|Procedure|Skin wound closure by tissue glue|The glue is used both as closure device and as wound dressing.
16183296|NCT01521871|Procedure|Skin wound closure by conventional suture + dressing|Suture: Intracutaneous skin closure, by running, absorbable suture (Caprosyn 4-0) Dressing: Conventional textile dressing (Mepor)
16183297|NCT01521845|Drug|omega 3|3 gram omega 3 (400mg EPA and 200mg DHA) 12hours before PCI
16183298|NCT01521832|Drug|SEN0014196|5 mg single oral dose
16183299|NCT01521832|Drug|SEN0014196|25 mg single oral dose
16183300|NCT01521832|Drug|SEN0014196|75 mg single oral dose
16183301|NCT01521832|Drug|SEN0014196|150 mg single oral dose
16183302|NCT01521832|Drug|SEN0014196|300 mg single oral dose
16183303|NCT01521832|Drug|SEN0014196|600 mg single oral dose
16183304|NCT01521832|Drug|SEN0014196|300 mg single oral dose (females)
16183305|NCT01521832|Drug|SEN0014196|100 mg multiple oral dose
16183306|NCT01521832|Drug|SEN0014196|300 mg multiple oral dose
16183307|NCT01521832|Drug|SEN0014196|100 mg BID multiple oral dose
16183308|NCT01521832|Drug|SEN0014196|100 mg BID multiple oral dose (females)
16183309|NCT01521819|Radiation|Iray|The Oraya IRay stereotactic radiotherapy device will be used to deliver a 16 Gy dose of radiation to the macula. The radiotherapy will be delivered in a single session utilizing three sequential beams, each depositing 5.3 Gy at the macula through calculated scleral entry points, crossing the pars plana region of the eye, and overlapping at the same region of the macula.
16183310|NCT01521819|Drug|Lucentis|Intravitreal injection of Lucentis as needed.
16183311|NCT01521806|Dietary Supplement|Dietary Fiber|Dietary fiber will be added to snack foods
16183312|NCT01521793|Drug|QLT091001|oral QLT091001 administered once daily for 7 days
16183313|NCT01521780|Procedure|MRI|Participants undergo volumetric & diffusion weighted (DW) MRI. Participants are scanned twice, with an intervening fifteen minute walk between the scans.
16183314|NCT01521780|Procedure|Pathology|Participants who are undergoing surgical resection of HCC per their standard of care treatment, will submit tumor samples for biomarker analysis.
16183315|NCT01521780|Procedure|Blood Samples|Blood is collected from participants during screening Visit 1 - 24.5 ml. During Visit 3, blood samples totaling 22 ml, are collected at least 6-18 hours post-resection, and every other day up to a week until discharge. At follow up Visit 4, 5.5 ml of blood is collected.
16183316|NCT01521780|Procedure|Blood Samples|Blood is collected from participants during screening Visit 1 - 24.5 ml, and follow up Visit 4 - 5.5 ml.
16183317|NCT01521767|Drug|tolterodine tartrate|4 mg single dose of extended release capsules
16183318|NCT01521767|Drug|tolterodine tartrate|4 mg single dose of microspheres in powder blend
16183319|NCT01521767|Drug|tolterodine tartrate|4 mg single dose of microspheres in powder blend
16183320|NCT01521767|Drug|tolterodine tartrate|4 mg single dose of microspheres in powder blend
16183321|NCT01521767|Drug|tolterodine tartrate|4 mg single dose of microspheres in powder blend
16183322|NCT01521741|Other|Breast Cancer-Related Lymphedema Screening|All patients enrolled in the trial will receive prospective BCRL screening from their pre-operative baseline throughout their breast cancer treatment process. All participants will be measured with perometry, bioimpedance spectroscopy, and patient-reported outcome measures.
16183323|NCT01521728|Other|Resistance Exercise|Resistance will be administered using a series of adjustable cuff weights for the upper limbs and hip flexion. Knee flexion and extension will be administered with a weight bench using a leg exercise attachment and free weights.
16183324|NCT01521728|Other|Endurance Exercise|Endurance will be administered using a minicycle. It can be used from a sitting position (chair or wheelchair) for lower limb exercise and then placed on a tabletop for upper limb use.
16183325|NCT01521728|Other|Stretching/Range-of-Motion|"Stretching and range of motion exercise is widely accepted as a standard of care for ALS management."
16183326|NCT01521715|Drug|Pazopanib|800 mg (2x400mg) pazopanib per day should be taken orally without food at least one hour before or two hours after a meal until progression or occurrence of intolerable toxicity.
16183327|NCT01521702|Drug|Neoadjuvant chemotherapy|four bi-weekly cycles of gemcitabine (intravenous infusion of 1000mg/m2 over 30 minutes) and oxaliplatin (intravenous infusion of 100mg/m2 over 2 hours,
16183328|NCT01521702|Procedure|surgery and Adjuvant chemotherapy|surgery and Adjuvant chemotherapy must be started within eight weeks after surgery and is based on the standard regimen using six cycles of gemcitabine (Gem 1000mg/m2 over 30 minutes) on days 1, 8, 15 every 4 weeks.
16183329|NCT01521689|Drug|Rituximab|Low doses of sub cutaneaous rituximab
16183330|NCT01521676|Genetic|molecular alteration|research of molecular alteration
16183331|NCT01521663|Drug|IPX159|
16183332|NCT01521663|Drug|Placebo|
16183333|NCT01521650|Dietary Supplement|Probiotics|Patients will gurgle and swallow a mixture of probiotic bacteria
16183334|NCT01521637|Procedure|Neuromuscular Electrical Stimulation of m. quadriceps femoris|Neuromuscular Electrical Stimulation of m. quadriceps femoris by using a commercially available muscle stimulator
16183335|NCT01521637|Procedure|Sham-treatment: no NMES|Sham comparator
16183336|NCT01521624|Drug|Metformin|Metformin 1000 mg Daily in two divided doses plus advice for lifestyle modification
16183337|NCT01521611|Radiation|Targeted radiotherapy|Yttrium-90 labelled anti-CD66 monoclonal antibody.
16183338|NCT01521598|Drug|SKL11197|SKL11197 drug product contains 150 mg of active ingredient. Dosing will be three times per day.
16183339|NCT01521598|Drug|Placebo|This is the placebo. Patients will be randomized the placebo.
16183340|NCT01521585|Drug|SEN0014196|50 mg oral once daily tablet
16183341|NCT01521585|Drug|SEN0014196|200 mg oral once daily tablet
16183342|NCT01521585|Drug|Placebo|oral once daily tablet
16183346|NCT01521546|Drug|eplerenone|25mg tablet, once daily by mouth for 12 months
16183347|NCT01521546|Drug|placebo|one tablet by mouth daily for 12 months
16183348|NCT01521533|Drug|NOX-A12|"Pilot Group (NOX A12 single agent, and combined with VD):
~3 cohorts of 3 patients will receive treatment with NOX A12 alone at a single dose of 1, 2 or 4 mg/kg i.v. 2 weeks before the combination treatment of NOX A12 and VD will start. The combination of NOX A12 and VD will follow a dose titration design beginning at 1 mg/kg NOX A12 (cycle 1) proceeding to dose levels of 2 mg/kg (cycle 2) and 4 mg/kg (cycle 3) NOX A12 in combination with VD. This is followed by consolidation in cycles 4-8 when NOX-A12 will be kept at the highest individually titrated dose.
~Expansion Group (NOX A12 in combination with VD):
~Expansion patients will not receive single agent NOX-A12, but will receive combination treatment as for the pilot group."
16183349|NCT01521520|Drug|ferumoxytol|Ferumoxytol at a dose of between 1 and 6 mg iron/kg body weight (maximum 510 mg/injection) will be administered via intravenous injection. Ferumoxytol will be administered with each series of MRIs.
16183350|NCT01521507|Device|LipiFlow System|In-office device treatment for meibomian gland dysfunction by a physician
16183351|NCT01521507|Device|Warm Compress Therapy + Lid Scrub|At-home daily warm compress therapy and lid hygiene
16183352|NCT01521494|Drug|PA21|
16183353|NCT01521494|Drug|PA21|
16183354|NCT01521494|Drug|PA21|
16183355|NCT01521494|Drug|PA21|
16183356|NCT01521494|Drug|Placebo|
16183357|NCT01521481|Other|Triple inguinal nerve block.|Ultrasound-guided genitofemoral, iliohypogastric and ilioinguinal nerve block with ropivacaine 5 mg/ml, 150 mg.
16183358|NCT01521481|Other|Unilateral subarachnoid anesthesia|Subarachnoid anesthesia with hyperbaric bupivacaine 10 mg/ml, 12 mg, homolateral to inguinal hernia.
16183359|NCT01521455|Drug|HCP0910|250/50, BID for 2 weeks
16183360|NCT01521455|Drug|Seretide Diskus|250/50, BID for 2 weeks
16183361|NCT01521442|Behavioral|Mindful Yoga Therapy|Veterans will participate in twice weekly Mindful Yoga Therapy, which includes meditation, breathing practices, mindful movement, and guided rest (yoga nidra), as well as daily home practice.
16183362|NCT01521442|Behavioral|Wait-list Control|Participants will receive Mindful Yoga Therapy intervention after 12 weeks from being enrolled. Veterans will participate in twice weekly Mindful Yoga Therapy, which includes meditation, breathing practices, mindful movement, and guided rest (yoga nidra), as well as daily home practice.
16183363|NCT01521416|Other|Data collection|"Data of patients diagnosed with acute respiratory illness is extracted from General Practice Research Database (GPRD), Hospital Episode Statistics (HES), the Health Protection Agency (HPA), Office of National Statistics (ONS), and National Health Service (NHS) Reference Costs, during the period January 21st 2001 and March 31st 2009 inclusive.
~All analyses of primary care data (GPRD) and separately for secondary care (HES) data will be repeated for all eligible patients, and the subset of patients with a linkage to additional data (HES, ONS). All analysis including secondary care data will be restricted to the subset of patients with linked HES data. Estimates of average burden per patient and total burden in the UK will be performed. Burden is defined as both resource use and cost. Annual incidence and burden will be calculated."
16183364|NCT01521403|Drug|Metronidazole|3x500 mg/day for 10 days
16183365|NCT01521403|Drug|Placebo|3x1 tablet per day for 10 days
16183366|NCT01521390|Drug|GSK573719 62.5 mcg (one strip)|GSK573719 62.5 mcg delivered by 1 strip configuration of novel dry powder inhaler
16183367|NCT01521390|Drug|GSK573719 62.5 mcg(two strips)|GSK573719 62.5 mcg delivered by 2 strip configuration of novel dry powder inhaler
16183368|NCT01521390|Drug|GSK573719 125 mcg (one strip)|GSK573719 125 mcg delivered by 1 strip configuration of novel dry powder inhaler
16183369|NCT01521390|Drug|GSK573719 125 mcg(two strips)|GSK573719 125 mcg delivered by 2 strip configuration of novel dry powder inhaler
16183370|NCT01521390|Drug|Placebo|Placebo, no active ingredient
16183371|NCT01521377|Drug|Placebo Moxifloxacin|Single dose placebo oral tablet Moxifloxacin
16183372|NCT01521377|Drug|Moxifloxacin|Single oral dose tablet Moxifloxacin (400mg)
16183373|NCT01521377|Drug|GSK573719/Vilanterol 125/25mcg|Single inhalation from GSK573719/Vilanterol 125/25mcg DPI once daily
16183374|NCT01521377|Drug|GSK573719|Single inhalation from GSK573719 500mcg DPI once daily
16183375|NCT01521377|Drug|GSK573719/Vilanterol 500/100mcg|Single inhalation from GSK573719/Vilanterol 500/100mcg DPI once daily
16183376|NCT01521377|Drug|Placebo DPI|Single Inhalation from matching Placebo DPI once daily
16183377|NCT01521364|Drug|Addition of different doses of clarithromycin.|"At week 1, 250mg clarithromycin once a day will be added to linezolid therapy during two weeks.
~At week 3, 500mg clarithromycin once a day will be added to linezolid therapy during to weeks."
16183378|NCT01521325|Drug|Amatuximab|Subjects will receive one infusion of radiolabeled amatuximab.
16183379|NCT01521312|Drug|saxagliptin|5mg a day for 11-14 weeks
16183380|NCT01521312|Other|placebo pill|one tablet a day for 11-14 weeks
16183381|NCT01521299|Drug|Hydroxyurea|oral hydroxyurea on days 1,8 and 15
16183382|NCT01521286|Other|Data collection|HZ and PHN booklet questionnaire and zoster brief pain inventory (ZBPI) questionnaire.
16183383|NCT01521273|Other|Bean varieties|10 x 50 g/ arm
16183384|NCT01521260|Procedure|placebo|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of rinsing with a placebo solution (saline with appearance of chlorhexidine + CPC) and 1 minute of saline rinsing.
16183385|NCT01521260|Procedure|Chlorhexidine|Implants with peri-implantitis lesions will be surgically exposed, followed by a mechanical cleansing using curettes and gauzes and cotton pellets soaked in saline, 1 minute of chemical cleansing using 0,12% chlorhexidine + cetylpyridinium chloride (CPC) without alcohol (Perio-aid®) and 1 minute of saline rinsing.
16183386|NCT01521247|Other|Asthma Transition Program|Asthma Education.
16183387|NCT01521234|Behavioral|Feedback of daily walking activity|Participants will wear accelerometers every weekday during in-patient rehabilitation to monitor walking activity. Feedback of daily walking activity will be provided to the patients' treating physiotherapists to assist with goal-planning around walking.
16183388|NCT01521221|Other|Hand grip maneuver|Hand grip on blood pressue cuff slightly inflated at 50-70% of maximal force for 1 minute
16183455|NCT01520688|Drug|Beclomethasone, Budesonide, Fluticasone|Beclomethasone 80mcg BID Budesonide 180 mcg BID Fluticasone 100mcg BID
16183389|NCT01521208|Device|LUCAS (Lund University Cardiac Assist Sysrem)|LUCAS device will be placed on patients suffering a cardiac arrest and continuous chest compressions will be performed, even while defibrillation is being applied
16183390|NCT01521208|Other|Manual chest compressions|Manual CPR according to 2010 ERC guidelines will be performed
16183391|NCT01521195|Device|Extracorporeal blood flow via ECMO machine|"Extracorporeal Membrane Oxygenation (ECMO) machine can provide complete support of heart and lung function.
~Extracorporeal blood flow will be given at baseline rate, increased by 25% and decreased by 25%"
16183392|NCT01521182|Other|1-Fermented Dairy Product (test)|1 = Intervention 1 (test product)
16183393|NCT01521182|Other|2-Milk-based non-fermented dairy product (control)|2 = Intervention 2 (control product)
16183394|NCT01521169|Other|1 - low-fat dairy fermented product (drinkable) enriched with plant sterols (0,8g /day equivalent as free sterols).|1 = Intervention with test product 1 (0,8g of plant sterol/day)
16183395|NCT01521169|Other|2 - low-fat dairy fermented product (drinkable) enriched with plant sterols (1,6g /day equivalent as free sterols).|2 = Intervention with test product 2 (1,6g of plant sterol/day)
16183396|NCT01521169|Other|3 - low-fat dairy fermented product (drinkable) without plant sterols.|3 = Intervention 3 (1 control product/day)
16183397|NCT01521156|Other|1- low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).|1 = Intervention 1 (1 test product/day)
16183398|NCT01521156|Other|2- low-fat dairy fermented product (drinkable) enriched with experimental plant sterols-esters (1,6g /day equivalent as free sterols).|2 = Intervention 2 (1 test product/day)
16183399|NCT01521143|Biological|Cvac|Injections were done at 4 anatomical sites, 1 injection in each of the upper portions of both arms and both thighs.
16183400|NCT01521143|Biological|Placebo|"Injections were done at 4 anatomical sites, 1 injection in each of the upper portions of both arms and both thighs.
~Placebo consisted of the Cvac formulation buffer (5% HSA, 10% DMSO) with 0.9% simethicone provided in 1 mL vials that had been cryopreserved and stored at the manufacturing facility."
16183401|NCT01521130|Drug|Levetiracetam|Medication doses are defined on a mg/kg basis. Dosage form, frequency and titration schedule is based on accepted clinical practice.
16183402|NCT01521117|Drug|Donepezil|Use 1 capsule (5 mg) of donepezil once per day for first 21 days than donepezil 10mg qday for 21 days.
16183403|NCT01521117|Drug|Placebo|Use 1 capsule (5 mg) once per day for first 21 days than 10mg qday for 21 days.
16183404|NCT01521078|Behavioral|Check Your Drinking University version|The CYDU is an internet-based intervention that provides a personalized feedback summary which compares the participant's drinking to that of other university students. The CYDU is a modified version of the Check Your Drinking screener which has been validated in four separate randomized controlled trials. The primary modification of the CYDU is that the population norms used for comparison are those of university students (in the USA or Canada).
16183405|NCT01521065|Device|IRay|Approved dose of Anti-VEGF injection given at Day 0 followed by treatment with 16 Gy dose of IRay up to 14 days later.
16183406|NCT01521052|Device|dTMS treatment (H1 Coil)|All subjects will receive prefrontal deep rTMS of H1 Coil (42 trains of 2 seconds, 10 Hz, with 20 seconds inter-train intervals, up to 120% of motor threshold), for 4 weeks, 5 days a week, overall 20 sessions.
16183407|NCT01521039|Procedure|Blood samples|2-3 tablespoons of blood weekly for the first 100 days (about 14 weeks) following allogeneic transplant. In addition a blood sample will be obtained before starting the chemotherapy or radiation regimen for the transplant, in the day of the transplant and if your doctor suspects that you have acute graft-versus-host disease.
16183408|NCT01521026|Behavioral|Cognitive Training|12-week compensatory cognitive training in group format
16183409|NCT01521013|Behavioral|Supported self-care|"Subjects will receive a package of depression self-care materials, to include the Antidepressant Skills Workbook, a mood monitoring tool, an informational video on depression, information for family members, and information on additional resources (reading materials, internet sites, community groups).
~Subjects will be contacted (by telephone) by their coach, initially at weekly intervals. The frequency of calls will thereafter be mutually determined by subject and coach, but will not exceed weekly calls during the first 3 months, or monthly calls from months 3 to 6. Calls will last an average of 10 minutes. The coach will follow a script to educate/ motivate/guide the subject in the use of the Workbook."
16183410|NCT01521013|Behavioral|Unsupported self-care|Subjects will receive a package of depression self-care materials, to include the Antidepressant Skills Workbook, a mood monitoring tool, an informational video on depression, information for family members, and information on additional resources (reading materials, internet sites, community groups).
16183411|NCT01521000|Device|Garment Sleeve|compression sleeve (20 to 30 mm of Hg)
16183412|NCT01520987|Drug|BIA 9-1067|5 mg, 25 mg, and 50 mg of BIA 9-1067 (once-daily).
16183413|NCT01520987|Drug|Placebo|once-daily
16183414|NCT01520974|Other|ProBiora3 mints|Probiotic mint tablet taken once daily for 12 weeks containing ProBiora3, a combination of three known healthy bacteria
16183415|NCT01520974|Other|Placebo tablet|Mint tablet taken once daily for 12 weeks without the ProBiora3 combination of three known healthy bacteria
16183416|NCT01520948|Behavioral|Exercise-based behavioral therapy|Pelvic floor muscle exercise training, bladder training, fluid management, constipation management
16183417|NCT01520948|Behavioral|Behavioral control|Mirrored star drawing
16183418|NCT01520935|Other|Data collection|"The study, will use four primary data sources: the General Practice Research Database (GPRD, for mild outcomes), the Hospital Episode Statistics database (HES, for hospitalizations), the Office of National Statistics mortality database (ONS, for mortality), and weekly virology data from the Health Protection Agency (HPA).
~Weekly time series of the rates of various influenza-related health outcomes in the various databases, such as office visits for acute otitis media and hospitalizations for pneumonia will be constructed. Statistical models, guided by weekly numbers of cases of laboratory-confirmed influenza and respiratory syncytial virus (RSV) contained in the HPA virology data, to estimate the portions of the various outcomes that can be attributed to influenza will be constructed. Finally, the seasonal impact of influenza by risk status, vaccination status, and seasons in which a well-matched versus mismatched influenza vaccine was used, will be assessed."
16183456|NCT01520675|Procedure|surgery|Drainage procedure
16183457|NCT01520675|Procedure|Endoscopic therapy|pancreatic sphincterotomy, removal of calculi, stenting, ESWL
16183419|NCT01520922|Biological|Ofatumumab|Ofatumumab (ARZERRA™) is an immunoglobulin G1κ (IgG1κ) human monoclonal antibody that specifically recognises a distinct epitope encompassing both large and small extracellular loops on the human CD20 molecule expressed on B cells and binds to this site with high affinity with a dissociation half-life of approximately 3 hours. Ofatumumab induces more efficient complement-dependent cytotoxicity (CDC) mediated cell lysis in vitro, compared to rituximab, especially in low CD20 density cells.
16183420|NCT01520922|Drug|Bendamustine|Bendamustine is a cytostatic drug which structurally combines a purine-like benzamidazol nucleus and a bifunctional alkylating nitrogen mustard group.
16183421|NCT01520909|Drug|Eltrombopag|Thrombopoietin receptor agonist
16183422|NCT01520909|Drug|Placebo|Placebo with no active pharmaceutical ingredient
16183423|NCT01520896|Drug|NKTR-118|Oral 25 mg
16183424|NCT01520896|Drug|Ketoconazole|Oral 400 mg
16183425|NCT01520870|Drug|PF-299804 (Dacomitinib)|Dacomitinib will be administered orally at a dose of 45 mg/day, until disease progression, unacceptable adverse side effects or study end.
16183426|NCT01520857|Procedure|Transabdominal Preperitoneal repair of inguinal hernia|Transabdominal Preperitoneal (TAPP) repair of inguinal hernia using CO2 pneumoperitoneum under spinal anesthesia
16183427|NCT01520857|Procedure|Transabdominal Preperitoneal repair of inguinal hernia|Transabdominal Preperitoneal (TAPP) repair of inguinal hernia using CO2 pneumoperitoneum under general anesthesia
16183428|NCT01520844|Biological|blood sampling|blood sampling
16183429|NCT01520831|Drug|biphasic insulin aspart 30|One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
16183430|NCT01520831|Drug|biphasic insulin aspart 50|One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
16183431|NCT01520831|Drug|biphasic insulin aspart 70|One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
16183432|NCT01520831|Drug|insulin aspart|One single dose of 0.3 U/kg body weight administered subcutaneously (s.c., under the skin) at one of four study days
16183433|NCT01520818|Drug|biphasic insulin aspart 50|Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner. Randomised subjects being obese with a body mass index (BMI) exceeding 30 kg/m^2 will receive BIAsp 50
16183434|NCT01520818|Drug|biphasic insulin aspart 70|Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner. Randomised subjects being lean and overweight with a body mass index (BMI) of maximum 30 kg/m^2 will receive BIAsp 70
16183435|NCT01520818|Drug|biphasic human insulin 30|Administered subcutaneously (s.c., under the skin), twice a day
16183436|NCT01520805|Drug|CPI-613|CPI-613 drug product, provided in concentrated form at 50 mg/mL, must be diluted with D5W prior to administration. CPI-613 is to be infused intravenously (IV) via a central venous catheter. The dose of CPI-613 will be either the Maximum Tolerated Dose (MTD) or the highest No-Significant- Adverse-Effects-Dose-Level (NOAEL), as determined from the nearly completed Phase 1 dose-escalation clinical trial in patients with hematologic malignancies (i.e., Cornerstone Study# CL-CPI-613-009 or Wake Forest Study# CCCWFU 29109, under IND 107,800).
16183437|NCT01520792|Drug|Paracetamol (drug)|Randomized, single-center, placebo-controlled, double-blind, cross-over in 100 healthy volunteers meeting the inclusion criteria and receiving 2g of paracetamol orally or placebo on two study periods separated by one week.
16183438|NCT01520766|Device|prefabricated titanium post|posts: diameter of 1.4 mm; length of 13 mm adhesively luted within the root canal using self-adhesive resin cement and direct composite cores using an etch-and-rinse adhesive were built up crown preparation was performed, while the finishing line for the final restoration was set at least 2 mm apical the composite build-up in dentin to ensure a proper dentin ferrule design
16183439|NCT01520766|Device|prefabricated glass fiber reinforced composite post|posts: diameter of 1.4 mm; length of 13 mm adhesively luted within the root canal using self-adhesive resin cement and direct composite cores using an etch-and-rinse adhesive were built up crown preparation was performed, while the finishing line for the final restoration was set at least 2 mm apical the composite build-up in dentin to ensure a proper dentin ferrule design
16183440|NCT01520753|Drug|biphasic insulin aspart 70|Administered subcutaneously (s.c., under the skin) at breakfast, lunch and dinner
16183441|NCT01520753|Drug|biphasic insulin aspart 70|Administered subcutaneously (s.c., under the skin) at breakfast and lunch
16183442|NCT01520753|Drug|biphasic insulin aspart 50|Administered subcutaneously (s.c., under the skin) at dinner
16183443|NCT01520740|Device|Emphysematous Lung Sealant|4 Subsegments treated - 2 each bilaterally
16183444|NCT01520740|Device|Emphysematous Lung Sealant|4 Subsegments treated - 2 each bilaterally
16183445|NCT01520727|Drug|BIA 9-1067|single ascending doses in up to 8 sequential groups of 8 healthy young male subjects
16183446|NCT01520727|Drug|Placebo|single-dose
16183447|NCT01520714|Device|Medtronic 4195 active fixation LV lead and Medtronic passive fixation LV lead|1:1 randomization between Medtronic active fixation 4195 LV lead and another FDA approved passive fixation Medtronic LV lead. Fluoroscopic images will be taken at implant in a supine position and again at 3 month follow-up in different postural positions with capture thresholds of the LV lead taken at each postural position.
16183448|NCT01520701|Device|bandage skin Hydrotac®|Patients randomized to the arm with bandage skin will benefit from the application of the bandage skin hydrogel (Hydrotac®) at least 5 hours per day for the duration of treatment (the first day last day of radiotherapy).
16183449|NCT01520701|Drug|Ialuset®|Patients randomized to receive reference of the application of cervical Ialuset® on skin throughout the treatment period (the first day to last day of radiotherapy).
16183450|NCT01520688|Drug|Fluticasone, Budesonide, Beclomethasone|Fluticasone 100 mcg bid Budesonide 180 mcg bid Beclomethasone 80 mcg bid
16183451|NCT01520688|Drug|Fluticasone, Beclomethasone, Budesonide|Fluticasone 100mcg BID Beclomethasone 80 mcg BID Budesonide 180 mcg BID
16183452|NCT01520688|Drug|Budesonide, Fluticasone, Beclomethasone|Budesonide180 mcg BID Fluticasone 100 mcg Beclomethasone 80 mcg BID
16183453|NCT01520688|Drug|Budesonide, Beclomethasone, Fluticasone|Budesonide 180 mcg BID Beclomethasone 80mcg BID Fluticasone 100mcg BID
16183454|NCT01520688|Drug|Beclomethasone, Fluticasone, Budesonide|Beclomethasone 80 mcg BID Fluticasone 100mcg BID Budesonide 180 mcg BID
16183618|NCT01519336|Drug|danoprevir|100 mg q12h
16183619|NCT01519336|Drug|darunavir|600 mg q12h
16183458|NCT01520662|Other|Implementation of a secure web-based patient Wellness Portal|Patients in intervention practices will review and update their wellness records, risk factor information, allergy and contraindication profile, and personal preferences through the Wellness Portal before they visit their primary care provider.
16183459|NCT01520649|Drug|NSI-189 Phosphate|The first cohort will be administered 40 mg once daily (q.d). The second cohort will be administered 40 mg twice daily (b.i.d). The third cohort will be administered 40 mg three times daily (t.i.d).
16183460|NCT01520649|Drug|microcrystalline cellulose capsules|The first cohort will be administered 40 mg once daily (q.d). The second cohort will be administered 40 mg twice daily (b.i.d). The third cohort will be administered 40 mg three times daily (t.i.d).
16183461|NCT01520636|Procedure|standard physiotherapy|daily physiotherapy aiming at preventing complications, going with the patient progress capacities, passive mobilisation, sitting as soon as possible, walking when possible, respiratory physiotherapy. 15-20 minutes total per day
16183462|NCT01520636|Procedure|experimental physiotherapy|physiotherapy as described above added to verticalisation as soon as possible; active, intense and repeated motor exercises for limbs and trunk with all the available techniques. 60 minutes total per day.
16183463|NCT01520623|Other|Serum concentration /Serum inflammatory|Allografted patients with myeloablative conditioning for an haematological malignancy. Patients will be followed for at least 12 months after transplantation and blood samples drawn before conditioning and once a week for 12 weeks after transplantation to analyze the serum concentration of Complement factors (C3, C4, B factor), Complement regulatory proteins (C1-inhibitor, I and H Factors) and analysis of the surface expression of Complement regulatory molecules such as CD46, CD55 and CD59 and the serum inflammatory cytokine levels
16183464|NCT01520584|Dietary Supplement|Vitamale|men will receive the vitamale dietary supplement compared to a sham pill
16183465|NCT01520571|Procedure|Non-Computer Assistance TKA|Non-Computer Assistance Total Knee Arthroplasty
16183466|NCT01520571|Procedure|Computer Assistance TKA|Computer Assistance Total Knee Arthroplasty
16183467|NCT01520558|Biological|CNDO-109-AANK Cells|Single dose, infusion
16183468|NCT01520545|Drug|Gablofen® 3 mg/mL (baclofen injection)|This is a prospective twelve-month Phase IIIb clinical safety trial followed by a 2-year, Phase IV study that will be conducted at clinical trial sites that are experienced with the use of intrathecal baclofen. Patients will be followed for the duration of their treatment with Gablofen® (baclofen injection) 3 mg/mL using the SynchroMed® II Programmable Pump or until the study is terminated.
16183469|NCT01520545|Device|SynchroMed® II Programmable Pump|Intrathecal programmable pump
16183470|NCT01520532|Other|Magnetic Resonance Imaging (MRI)|MRI's will be performed on all subjects at Enrollment and Pre-Discharge (Post Ablation). Subjects with a positive MRI (cerebral lesion) at the Pre-Discharge will undergo an MRI at the 1 month follow-up visit.
16183471|NCT01520519|Drug|Rituximab|375 mg/m2 intravenously on Day 1, Day 8, Day 15, and Day 22, then continued once every 4 weeks only on Days 1 during cycles 2 - 6.
16183472|NCT01520519|Drug|PCI-32765|420 mg (3 * 140-mg capsules) orally started on Day 2 of cycle 1 once daily and will be continued daily.
16183473|NCT01520506|Device|Covidien OneShot™ System|Placed percutaneously, the OneShot™ balloon catheter is advanced into the renal artery using a routine femoral approach in a cardiac catheterization laboratory setting. RF is applied with pre-programmed time and intensity in each of the renal arteries.
16183474|NCT01520493|Other|Submaximal exercises|Consists of a 3-min unloaded exercise, followed by a progressive RAMP protocol (10 watts/min) up to 70% of peak workload followed by 3 min. of cycling at constant workload (70% peak workload) (total exercise duration of 25 min.).
16183475|NCT01520467|Drug|Anastrozole|Anastrozole (1mg/day), administered orally for 18 months
16183476|NCT01520467|Drug|Placebo|1 placebo tablet /day administered orally for 18 months.
16183477|NCT01520454|Drug|Saline|IV saline at 0.83 mL/kg/hr for six hours
16183478|NCT01520454|Drug|Intralipid|Intralipid in either low-dose or high dose (10% vs. 20%) at 0.83 mL/kr/hr for six hours
16183479|NCT01520454|Dietary Supplement|Water|Water by mouth
16183480|NCT01520454|Dietary Supplement|oral fat|Soybean oil by mouth at 1.25 g/kg x 2 doses
16183481|NCT01520454|Drug|Heparin|Heparin bolus of 1000 units followed by 800 u/hr, adjust per partial thromboplastin time (PTT), for 5.5 hours
16183482|NCT01520441|Drug|BOTOX|A total of 200 units of BoNT-A diluted in 4ml of preservative free saline will be injected into the right prostate lobe (i.e. transition and peripheral zones). A similar injection template with 1.0ml volume injections of saline will be injected into the left prostate lobe (2 injections in transition zone, 2 injections in peripheral zone for total volume of 4ml).
16183483|NCT01520428|Behavioral|Motivational Interviewing, CBT and E-mail support|Motivational Interviewing, elements of Cognitive Behaviour Therapy and E-mail support
16183484|NCT01520415|Drug|Bupivacaine|2ml per injection up to a maximum of 8ml (4 identified trigger points) per visit
16183485|NCT01520415|Drug|Saline|2ml per injection up to a maximum of 8ml (4 identified trigger points) per visit
16183486|NCT01520402|Drug|Warfarin|Enrolled subjects on a fixed vitamin K diet followed a standard warfarin dosing algorithm with daily point-of-care INR checks to goal INR ≥ 2 for two consecutive days, then to baseline INR≤1.2 off warfarin. Genotyping for common and rare polymorphisms in CYP2C9, VKORC1, and CYP4F2 performed at study entry and unblinded at completion. Plasma Vitamin K and S-warfarin levels are obtained at goal INR ≥ 2 and study exit (INR ≤1.2 off warfarin).
16183487|NCT01520389|Drug|MM-151|MM-151
16183488|NCT01520389|Drug|MM-151 + irinotecan|MM-151 + irinotecan
16183489|NCT01520376|Behavioral|Counselling|Visit by a psychiatrist at day-30 and day-180 after discarge
16183490|NCT01520363|Drug|dextromethorphan|The DM group will take 5mg/kg/day orally in 2 divided doses 12 hours apart for the 3 month period of the study. The pharmacists will dispense the DM to the study participants.
16183491|NCT01520363|Drug|placebo|The placebo will be dispensed to equal the volume of DM of 5mg/kg/day. It is taken orally in 2 divided doses 12 hours apart during the study period of 3 months. The Research pharmacist will dispense the placebo to the participants.
16183492|NCT01520350|Drug|Low dose Adjunctive Aripiprazole|low-dose 2-5mg/d for 8 weeks
16183493|NCT01520350|Drug|placebo|Placebo
16183494|NCT01520337|Device|oral tablet dye for detection of polyps during colonoscopy|oral tablet dye for improved detection of
16183620|NCT01519336|Drug|ritonavir|100 mg q12h
16183495|NCT01520324|Device|oral delivery mucosal stain|200mg methylene blue MMX tablet taken prior to colonoscopy
16183496|NCT01520311|Device|eSVS Mesh|Patients with multi-vessel coronary artery disease who require SVG CABG of the Right Coronary Artery and the Circumflex Artery due to atherosclerotic Coronary Artery Disease will serve as their own control. They will be randomized to either an SVG+eSVS Mesh to the RCA and an SVG to the Cx or an SVG to the RCA and an SVG+eSVS Mesh to the Cx.
16183497|NCT01520298|Drug|Placebo|For the control group, a total of 100 mLs of 0.9% sodium chloride will be transferred to a Hospira LifeCare container and infused over 15 minutes (6.7 mL/min). A beyond use expiration of 6 hours will be placed on the container. All admixture manipulations will be completed by the pharmaceutical staff according to the chapter 797 guidelines in the U.S. Pharmacopoeia. The treatment period will begin after admission and randomization, and will continue until surgical intervention.
16183498|NCT01520298|Drug|Acetaminophen IV|For the treatment group, a total of 100 milliliters (mLs) of acetaminophen (1000 mg) will be transferred to a Hospira LifeCare container and infused over 15 minutes (6.7 mLs/min). A beyond use expiration of 6 hours at room temperature will place on the container, as recommended by the manufacturer. All admixture manipulations will be completed by the pharmaceutical staff according to the chapter 797 guidelines in the U.S. Pharmacopoeia. The treatment period will begin after admission and randomization, and will continue until surgical intervention.
16183499|NCT01520285|Drug|Zanidip|Lercanidipine hydrochloride (10mg/tablet)once per day
16183500|NCT01520285|Drug|Felodipine sustained-release tablet|Felodipine sustained-release tablet (5mg/tablet)
16183501|NCT01520246|Genetic|gene expression analysis|
16183502|NCT01520246|Other|laboratory biomarker analysis|
16183503|NCT01520233|Genetic|RNA analysis|
16183504|NCT01520233|Genetic|gene expression analysis|
16183505|NCT01520233|Other|laboratory biomarker analysis|
16183506|NCT01520220|Drug|LY2784544|LY2784544 will be taken by mouth per a specified schedule. Each cycle is 28 days.
16183507|NCT01520207|Drug|Mannitol (20%)|0.25g/kg/hour (maximum rate 25g/hour; maximum 75g per session; maximum volume 375mLs per session)
16183508|NCT01520207|Drug|0.9% saline|1.25mL/kg/hour; maximum 125mLs/hour; maximum total volume 375mLs per treatment
16183509|NCT01520194|Other|women attending reproductive health clinics|women visiting BEMFAM´s clinics from January 2012 until Narch 2013 filled a self-administered questionnaire based on psychometric scale developes by Zhu TC et al
16183510|NCT01520194|Other|medical records|medical chart review of patients assisted January 2009 to December 2010
16183511|NCT01520181|Drug|Beta-lactam oral challenge|Oral daily dose, according to patient's weight, of amoxicillin or other suspected beta-lactam will be administered for 5 consecutive days
16183512|NCT01520142|Drug|JNJ-26528398|In Study Part 1, the participant will receive an oral solution of JNJ-26528398 3 mg once daily for 7 days. The same dosing regimen is planned for Part 2, but may be adjusted (lower dose and/or fewer dosing days) based on the data from Part 1.
16183513|NCT01520142|Drug|Placebo|In both Study Part 1 and Part 2, the participant will receive an oral solution of matching placebo once daily for up to 7 days.
16183514|NCT01520129|Other|Interpersonal and social rhythm therapy|IPSRT Subjects will receive weekly 45 minute sessions of IPSRT for 20 weeks. IPSRT sessions focus on reducing symptoms by teaching patients to: a) increase regularity of social rhythms and regulate sleep-wake cycles; b) resolve interpersonal problems that contribute to mood symptoms (role dispute, role transition, grief, or interpersonal deficits); and c) recognize and accept the symptoms of subthreshold BP disorder (psychoeducation). Although we train therapists in techniques that are specific to each component, in practice, these strategies are administered flexibly and fluidly, without distinct boundaries between modalities. During the course of a session, therapists move seamlessly among the techniques, according to patients' needs.
16183515|NCT01520116|Drug|Stage 1 - ATS907 - Dose 1|QD and/or BID dosing for 28 days
16183516|NCT01520116|Drug|Stage 1 - ATS907 - Dose 2|QD and/or BID dosing for 28 days
16183517|NCT01520116|Drug|Stage 1 - ATS907 - Dose 3|QD and/or BID dosing for 28 days
16183518|NCT01520116|Drug|Stage 1 - ATS907 - Dose 4|QD and/or BID dosing for 28 days
16183519|NCT01520116|Drug|Stage 1 - Vehicle|QD and/or BID dosing for 28 days
16183520|NCT01520116|Drug|Stage 2 - ATS907 - Dose A - to be selected based on Stage 1|QD and/or BID dosing for 4 days
16183521|NCT01520116|Drug|Stage 2 - ATS907 - Dose B - to be selected based on Stage 1|QD and/or BID dosing for 4 days
16183522|NCT01520116|Drug|Timoptic|0.5%
16183523|NCT01520103|Drug|Vinorebine, Everolimus|Vinorelbin: i.v. 25 mg/ m² d1, d8, d15 3qw Everolimus: oral 5 mg/d d1-21 3qw until progress
16183524|NCT01520103|Drug|Vinorelbine|Vinorelbin: i.v. 25 mg/ m² d1, d8, d15 3qw until progress
16183525|NCT01520077|Drug|vytorin|Patient will take once per day by mouth Vytorin 10/40mg. Will take it for 24 weeks and then continue or discontinue treatment at that time and be monitored for 24 more weeks. Should there be no improvement by the initial 24 weeks then they will no longer be in the study.
16183526|NCT01520051|Drug|Mepolizumab|3 monthly intravenous infusions of 750 mg
16183527|NCT01520051|Drug|Placebo|3 monthly intravenous infusions with saline
16183528|NCT01520038|Radiation|Proton therapy|
16183529|NCT01520038|Radiation|IMRT|
16183530|NCT01520025|Radiation|PET MPI imaging with 18F-Fluorodeoxyglucose|"Exercise Stress Testing. All patients will undergo a symptom-limited exercise treadmill test using the Bruce protocol after a 24 hour high fat, low carbohydrate diet and an overnight fast. Persantine Stress Testing: Subjects who have undergone Persantine stress protocol for the PET or SPECT will follow the same protocol. A high fat, low carbohydrate diet for 24 hours and a 12 hour overnight fast will precede the study stress scan. Anti-anginal medications will be withheld on the morning of the exercise test.
~18FDG (370 mBq) will be injected at either peak exercise or within 1 hour of peak.
~Patients will be imaged 60 minutes after radiotracer injection in the supine position in a Discovery 690/VCTLYSO PET system (GE Healthcare, Milwaukee, Wisconsin)"
16183531|NCT01520012|Drug|YH4808 100 mg|Period1: YH4808 100 mg bid fasting condition for 7days Period2: YH4808 100 mg bid fed condition for 7days
16183532|NCT01520012|Drug|YH4808 100 mg|Period1: YH4808 100 mg bid fed condition for 7days Period2: YH4808 100 mg bid fasting condition for 7days
16183533|NCT01520012|Drug|YH4808 300 mg|Period1: YH4808 300 mg fasting condition Period2: YH4808 300 mg fed condition(standard meal) Period3: YH4808 300 mg fed condition(high fat meal)
16183534|NCT01520012|Drug|YH4808 300 mg|Period1: YH4808 300 mg fed condition(high fat meal) Period2: YH4808 300 mg fasting condition Period3: YH4808 300 mg fed condition(standard meal)
16183535|NCT01520012|Drug|YH4808 300 mg|Period1: YH4808 300 mg fed condition(standard meal) Period2: YH4808 300 mg fed condition(high fat meal) Period3: YH4808 300 mg fasting condition
16183536|NCT01519999|Behavioral|Shared Decision Making for Colorectal Cancer Screening|Age-eligible adults in the intervention communities will be exposed to the shared decision-making intervention when they are seen in the primary care clinics (N=all patients 50-75 years seen during the study period who are non-adherent to CRCS recommendation). Additionally, among patients with primary care visits scheduled one week or more before the visit, they will be randomized to receive either a mailed decision aid booklet or an informational flyer on shared decision making and CRCS prior to the visit. Patients with primary care visits scheduled less than one week prior to the visit will not be mailed materials in advance. The effect of the pre-visit materials on referral to SDM session and CRCS adherence between these groups will be compared. They will also be exposed to shared decision-making tools and resources available through the community-wide intervention activities.
16183537|NCT01519986|Dietary Supplement|Vitamin D3|Supplement of vitamin D3
16183538|NCT01519986|Dietary Supplement|Placebo|Placebo
16183539|NCT01519973|Radiation|SPECT/CT processed with Evolution for CardiacTM software|SPECT/CT to be compared with PET/CT
16183540|NCT01519960|Drug|peginterferon alfa-2a [Pegasys]|Body surface area adapted doses of 45-180 mcg subcutaneously weekly for 48 weeks, Weeks 1- 48
16183541|NCT01519960|Drug|peginterferon alfa-2a [Pegasys]|Body surface area adapted doses of 45-180 mcg subcutaneously weekly for 48 weeks, after Week 48 for Group B patients who have not experienced HBeAg seroconversion
16183542|NCT01519947|Drug|Methoxy polyethylene glycol-epoetin beta|Participants received 50-250 mcg SC according to local label
16183543|NCT01519921|Drug|peginterferon alfa-2a [Pegasys]|Peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once a week for 48 weeks
16183544|NCT01519908|Device|CRT-D (Medtronic)|Biventricular implantable cardioverter defibrillator, post marketing release
16183545|NCT01519895|Behavioral|Telephone intervention|counseling and education support
16183546|NCT01519882|Other|Placebo|"Placebo patches size equivalent to 4, 6 & 8 mg/24 h. Daily application of Placebo patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
~Optimal or maximal dose will be maintained for 4 Weeks followed by a de-escalation by 2 mg/24 h every other day."
16183547|NCT01519882|Other|Rotigotine|"Rotigotine patches of 4,6 & 8 mg/24 h. Daily application of Rotigotine patches starting at 4 mg/24 h. Dose will be up-titrated weekly by increments of 2 mg/24 h until optimal or maximal dose is reached. Maximal dose is 16 mg/24 h.
~Optimal or maximal dose will be maintained for 4 weeks followed by a de-escalation by 2 mg/24 h every other day."
16183548|NCT01519869|Drug|neoadjuvant chemotherapy|platinum-based neoadjuvant chemotherapy followed by interval surgical debulking with platinum-based adjuvant chemotherapy
16183549|NCT01519856|Drug|piribedil (Clarium)|oral tablets, 50 mg
16183550|NCT01519843|Device|transcranial direct current stimulation tDCS|tdcs (ELDITH, Neuroconn, Ilmenau, Germany)
16183551|NCT01519843|Device|transcranial magnetic stimulation TMS|TMS (The Magstim Company Ltd, UK) Magstim 200² with a figure-of-eight coil was used to determine the hot spot eliciting consistent movements in the contralateral hand
16183552|NCT01519830|Drug|Iron carboxymaltose (Ferinject)|Intravenous iron
16183553|NCT01519830|Drug|Placebo|0.9% NaCl solution
16183554|NCT01519817|Biological|GI-6301 (Yeast Brachyury Vaccine)|GI-6301 is a heat-killed, recombinant yeast-based vaccine engineered to express the transcription factor, Brachyury. The Brachyury gene is used to transfect the parental yeast strain (S. cerevisiae W303 - a haploid strain with known mutations from wildtype yeast) to produce the final recombinant vaccine product.
16183555|NCT01519804|Drug|Placebo|Matching onartuzumab (MetMAb) placebo iv, Day 1 of each 21-day cycle
16183556|NCT01519804|Drug|cisplatin/carboplatin|standard dose iv, Day 1 of each 21-day cycle, 4 cycles
16183557|NCT01519804|Drug|onartuzumab|15 mg/kg iv, Day 1 of each 21-day cycle
16183558|NCT01519804|Drug|paclitaxel|200 mg/m2 iv, Day 1 of each 21-day cycle, 4 cycles
16183559|NCT01519791|Biological|Certolizumab Pegol|"Prefilled syringes containing an injectable volume of 1 ml of solution for injection CZP for single use at a dosage strength of 200 mg/ml.
~Injections will be given subcutaneously. CZP 400 mg at Baseline, Week 2 and Week 4, followed by a maintenance dose of 200 mg every 2 Weeks until Week 50."
16183560|NCT01519791|Other|Placebo|2 syringes Placebo at Baseline, Week 2 and Week 4, followed by 1 syringe Placebo every 2 Weeks.
16183561|NCT01519791|Biological|Methotrexate|The MTX treatment is to be initiated at a dose of 10 mg per Week (oral tablets at the strength of 2.5 mg/tablet). The MTX dosage should be escalated by 5 mg every 2 Weeks such that the maximum dosage of 25 mg per Week is achieved by Week 6 to Week 8. Patients who could not tolerate ≥ 15 mg/week MTX by Week 8 were withdrawn while the maximum tolerated dose per patient (optimized dose) was maintained to Week 52.
16183562|NCT01519778|Drug|TR701 FA|1 tablet 200 mg once daily
16183563|NCT01519765|Drug|Buccal Misoprostol|Buccal rather than Vaginal misoprostol for induction of labor
16183564|NCT01519765|Drug|Vaginal misoprostol|Vaginal rather than buccal misoprostol for induction of labor
16183565|NCT01519752|Drug|Oxiconazole Nitrate Cream 1%|Oxiconazole Nitrate Cream 1% applied to affected area once a day for 28 days
16183566|NCT01519752|Drug|Oxiconazole Nitrate Cream 1% (Oxistat®)|Oxiconazole Nitrate Cream 1%(Oxistat®)applied to affected area once a day for 28 days
16183567|NCT01519752|Drug|Placebo|Placebo applied to affected area once a day for 28 days
16183568|NCT01519739|Device|MediGuide™|MediGuide™ system will be used to guide CRT implants
16183569|NCT01519726|Drug|Midazolam|
16183570|NCT01519713|Biological|Meningococcal polysaccharide diphtheria toxoid conjugate|0.5 mL, Intramuscular
16183571|NCT01519700|Drug|EP2006|Eligible patients will be teated with EP2006
16183572|NCT01519700|Drug|Filgrastim|Eligible patients will be teated with Filgrastim
16183573|NCT01519687|Drug|levotofisopam|50 mg on Day 1, 50 mg TID on Days 2 through 6, and a single dose of 50 mg on Day 7
16183574|NCT01519674|Drug|biphasic insulin aspart 30|BIAsp 30 will be injected subcutaneously (under the skin) twice daily. Individually adjusted dose.
16183575|NCT01519674|Drug|biphasic insulin aspart 30|BIAsp 30 will be injected subcutaneously (under the skin) once daily. Individually adjusted dose.
16183576|NCT01519674|Drug|sitagliptin|Subjects will continue on their pre-trial sitagliptin treatment.
16183577|NCT01519674|Drug|metformin|Subjects will continue on their pre-trial metformin treatment.
16183578|NCT01519661|Drug|TBM100|Tobramycin inhalation powder was assigned as four capsules at 28mg dosage strength. It was inhaled b.i.d in the morning and in the evening via the T-326 Inhaler.
16183579|NCT01519635|Drug|Aliskiren|Drug therapy will be started with an initial 2 weeks on Aliskiren 150 mg followed by a titration to 300 mg Aliskiren if the treatment is well tolerated. A first baseline measurements will be performed before initiating therapy and a second after 8 weeks of treatment (24h after last drug intake) to assess the chronic effect.
16183580|NCT01519635|Drug|Hydrochlorothiazide|Drug therapy will be started with an initial 2 weeks HCTZ 12.5 mg followed by a titration to 25 mg HCTZ if the treatment is well tolerated. A first baseline measurements will be performed before initiating therapy and a second after 8 weeks of treatment (24h after last drug intake) to assess the chronic effect.
16183581|NCT01519622|Other|Questionnaire|Questionnaire to be distributed among sick elderly in the community
16183582|NCT01519609|Drug|bowel prep before endoscopy|bowel prep before colonoscopy
16183583|NCT01519596|Procedure|quality-of-life assessment|Ancillary studies
16183584|NCT01519596|Other|counseling intervention|Receive lifestyle-related counseling
16183585|NCT01519596|Behavioral|exercise intervention|Undergo physical activity intervention
16183586|NCT01519596|Other|educational intervention|Receive educational materials
16183587|NCT01519596|Procedure|standard follow-up care|Undergo usual care
16183588|NCT01519583|Behavioral|Basic Intervention|Participants will have the goal of obtaining 10,000 steps/day. In addition, participants will attend a meeting once a week with study staff, during which pedometers will be checked, and staff will provide a behavioral intervention to improve physical activity levels
16183589|NCT01519583|Behavioral|Enhanced Pedometry|Intensity Enhanced Pedometry: Participants will have the goal of obtaining 10,000 steps/day at least 30 minutes in moderate intensity (i.e., at a cadence of at least 100 steps/min). In addition, participants will attend a meeting once a week with study staff, during which pedometers will be checked, and the staff will provide a behavioral intervention to improve physical activity levels.
16183590|NCT01519583|Behavioral|Control Group|Maintain usual physical activity, and return for follow-up measures.
16183591|NCT01519570|Other|An informational packet regarding shingles and the HZV was sent to patients identified by the EMR|The EMR generated a list of patients aged 60 or older without HZV documentation. Patients were categorized into two subgroups based on activated electronic patient portal (EPP) status. Randomized patients from each subgroup received an informational packet regarding shingles and the HZV by either the EMR or USPS mail, depending on EPP status. A pharmacist reviewed the medical chart of interested patients to assess if the HZV was clinically indicated; eligible patients were mailed a HZV prescription.
16183592|NCT01519557|Drug|DAR-100A|15mg or 0.5mg of DAR-100A intravenously over 30 minutes for 5 days, 9 days off then again for 5 more days
16183593|NCT01519557|Drug|Placebo|Placebo
16183594|NCT01519544|Drug|Temazepam|Temazepam 7.5mg capsule to be taken by mouth at bedtime for one night only.
16183595|NCT01519544|Drug|Acetazolamide|Take Acetazolamide 125mg tablet by mouth at bedtime for one night only.
16183596|NCT01519531|Drug|Placebo|Oral, daily-dosing for 14 days; matching number of placebo capsule(s) with active arm
16183597|NCT01519531|Drug|VIA-3196|Oral, daily dosing for 14 days
16183598|NCT01519518|Drug|unfractionated heparin|70 units/kg body weight intravenous
16183599|NCT01519518|Drug|Bivalirudin|intravenous bolus of 0.75 mg/kg followed by infusion of 1.75 mg/kg per hour
16183600|NCT01519505|Behavioral|Lifestyle intervention|INDIVIDUAL INTERVENTIONS They were programmed to come the nurse office three times (1 ½ -2 hours each). Individual intervention efforts outside of weight control and other intervention groups were also supported. In fact, this kind of intervention was similar to the group intervention but one-by-one participant subject. GROUP INTERVENTIONS Six-hour educational programme structured in 2 to 4 sessions with 5 to 15 participants. We called all participants to remind them their group schedule (date/hour). The methods used in the group intervention were variable depending on the experience of the manager, group member' s needs and skills available (empowerment). Results were based on motivation, support from the other members, peer support and positive feedback.
16183601|NCT01519492|Drug|AFN-12520000|Two tablets taken in both the morning and evening on an empty stomach for a total daily dose 400 mg
16183602|NCT01519479|Other|Palliative Care Consultation|Intervention patient would receive an inpatient palliative care consultation to focus on comprehensive symptom assessment, create goals of care/treatment plan which include recommendations and referrals.
16183603|NCT01519479|Other|Control|The control group would receive usual care and could receive a palliative consult if ordered by the treating provider
16183604|NCT01519466|Device|FreeStyle InsuLinx|FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature.
16183605|NCT01519466|Device|FreeStyle Freedom Lite|FreeStyle Freedom Lite is a blood glucose meter
16183606|NCT01519453|Behavioral|Home Based Asthma Education|4 home based and 3 phone based sessions with community asthma outreach worker to provide families with asthma education
16183607|NCT01519427|Drug|Akt inhibitor MK2206|Given PO
16183608|NCT01519427|Drug|selumetinib|Given PO
16183609|NCT01519427|Other|laboratory biomarker analysis|Correlative studies
16183610|NCT01519414|Other|Laboratory Biomarker Analysis|Optional correlative studies
16183611|NCT01519414|Other|Placebo|Given PO
16183612|NCT01519414|Drug|Tivantinib|Given PO
16183613|NCT01519401|Drug|3 mg drospirenone and 20 µg ethinyl-estradiol|
16183614|NCT01519401|Drug|3 mg drospirenone and 30 µg ethinyl-estradiol|
16183615|NCT01519388|Other|Spontaneous breathing|study of the swallowing of boluses of water and yogurt under spontaneous breathing
16183616|NCT01519388|Device|Elysée 150®|Study of the swallowing of boluses of water and yogurt while under mechanical ventilation
16183617|NCT01519349|Biological|rAAV1.CMV.huFollistatin344|"First cohort - Low Dose: 2E11 vg/kg with single leg injection (n=3 sIBM)
~Second cohort: 3E11 vg/kg per quad (n=3 sIBM; 3 BMD)
~Third cohort: 6E11 vg/kg per quad (n=3 sIBM; 3 BMD)"
16183621|NCT01519323|Drug|vemurafenib|Cohort 1 (participants >=45 kg): starting dose level 720mg; next dose level 960 mg Cohort 2 (participants <45 kg): starting dose 480 mg
16183622|NCT01519310|Other|Antibiotic (metronidazole and ciprofloxacin)/probiotic|"Antibiotic cocktail/yogurt as follows:
~Group 1: antibiotics for 1 week, followed by probiotics for 3 weeks; Group 2: antibiotics for 1 week, followed by no probiotics for 3 weeks. Group 3: no antibiotics for 1 week, followed by probiotics for 3 weeks."
16183623|NCT01519297|Drug|Irbesartan|150mg orally for one dose
16183624|NCT01519284|Drug|BIA 9-1067 5 mg|BIA 9-1067 OPC, Opicapone 5 mg
16183625|NCT01519284|Drug|Entacapone|Entacapone 200 mg
16183626|NCT01519284|Drug|Placebo|placebo (four times a day)
16183627|NCT01519284|Drug|levodopa/carbidopa|standard release levodopa/carbidopa 100/25 mg (single-dose)
16183628|NCT01519284|Drug|BIA 9-1067 15 mg|BIA 9-1067 OPC, Opicapone 15 mg
16183629|NCT01519284|Drug|BIA 9-1067 30 mg|BIA 9-1067 OPC, Opicapone 30 mg
16183630|NCT01519271|Drug|Exelon Patch (rivastigmine transdermal system)|"The Exelon Patch (rivastigmine transdermal system) is a Cholinesterase Inhibitor approved by the FDA to treat Alzheimer's and Parkinson's Disease Dementia.
~5-10cm2 (4.6-9.5 mg of rivastigmine/24 hours )"
16183631|NCT01519271|Drug|Placebo Patches|The placebo patches will appear identical to the medication patches however they will be inactive (they will not contain rivastigmine).
16183632|NCT01519258|Other|Pressure Support ventilation|Patients will receive usual care during the period of ventilation on the Pressure Support. The same ventilator, the Servoi (maquet, Sweden) will be used.
16183633|NCT01519258|Device|NAVA|Patients will be ventilated with NAVA for 15 minutes. Back up settings in pressure support mode will be set in case the esophageal catheter is misplaced, and back up settings in pressure control ventilation will be set in case no inspiratory efforts are detected for longer than 15 seconds
16183634|NCT01519245|Drug|Tranexamic Acid|Solution containing 2 grams (20mL) tranexamic acid + normal saline (50mL), for a total volume of 70mL poured over the heart as a 'cardiac bath' prior to sternotomy closure near the end of surgery. Total duration of immersion is approximately 10 minutes, until mediastinal chest tubes are connected to suction.
16183635|NCT01519245|Drug|normal saline|A total volume of 70mL of normal saline poured over the heart as a 'cardiac bath' prior to sternotomy closure near the end of surgery. Total duration of immersion is approximately 10 minutes, until mediastinal chest tubes are connected to suction. Identical in appearance to the trial drug, and is visually indistinguishable.
16183636|NCT01519232|Radiation|Liver Irradiation|Patients already scheduled to undergo radiation treatment
16183637|NCT01519219|Radiation|Hepatic Irradiation|Patients who take part in this study are required to be scheduled for hepatic irradiation. For the purposes of this research, they will undergo IC-GREEN testing within 2 weeks prior to the start of radiation therapy
16183638|NCT01519206|Device|Ulthera System Treatment|Focused ultrasound energy delivered below the surface of the skin.
16183639|NCT01519193|Behavioral|Narrative Exposure Therapy for violent offenders (NETvo)|During NETvo the client, with the assistance of the therapist, constructs a chronological narrative of his whole life with a focus on exposure to traumatic stress and also on perpetrated violent acts. Empathic understanding, active listening, congruency and unconditional positive regard are key components of the therapist's behavior who asks in detail for emotions, cognitions, sensory information, and physiological reactions, linking them to an autobiographical context. Positive emotions and cognitions reported for violent acts are linked to the respective past. During four sessions the most important traumatic experiences and perpetrated violent acts are processed. In the fifth session plans and ideas for the future are developed to assist the children to reintegrate themselves into society.
16183640|NCT01519167|Drug|Dexmedetomidine|0.1 - 1.0 mcg/kg/hr IV
16183641|NCT01519167|Drug|Midazolam|0.025 - 2 mg/kg IV
16183642|NCT01519167|Drug|Fentanyl|0.5 - 3 mcg/kg IV
16183643|NCT01519154|Drug|Propofol|Only Propofol titrated for induction, followed by Propofol 10 mg/h as maintenance infusion
16183644|NCT01519154|Drug|Ketamine-Propofol|Propofol titrated plus additional Ketamine 1 mg/kg at induction, followed by Propofol 10 mg/h as maintenance infusion
16183645|NCT01519128|Drug|Treatment A: Digoxin|Type=exact number, unit=mg, number=0.5, form=tablet, route=oral. Digoxin administered on Day 1.
16183646|NCT01519128|Drug|Treatment B: TMC278|Type=exact number, unit=mg, number=25, form=tablet, route=oral. TMC278 administered for 16 days, with digoxin administered in the morning on Day 11.
16183647|NCT01519115|Other|early physical therapy intervention|instruction in home care program to be followed for first six weeks after ACF surgery
16183648|NCT01519115|Other|usual care|one physical therapy visit in hospital following ACF surgery
16183649|NCT01519102|Device|Dual Hormone closed-loop system|The closed-loop system is composed of three components: continuous glucose system, insulin infusion pumps that infuses insulin and glucagon and a control algorithm that decides on the infusion rates based on sensor readings.
16183650|NCT01519089|Drug|CP-690,550|10 mg BID, continuous treatment for 16 weeks under blinding, 10 mg BID, continuous treatment for 4 weeks and variable dose (5 mg or 10 mg), continuous treatment for 32 weeks.
16183651|NCT01519089|Drug|CP-690, 550|5 mg BID, continuous treatment for 16 weeks under blinding, 10 mg BID, continuous treatment for 4 weeks and variable dose (5 mg or 10 mg), continuous treatment for 32 weeks.
16183652|NCT01519076|Device|Pulse Therapeutics (PTI) Magnetically-Enhanced Diffusion (MED)|The PTI MED System is a magnetic-controlled infusion system which uses external energy (magnetic energy) to drive an agent (tPA) to the desired target (blood clot).
16183653|NCT01519063|Drug|Naltrexone and memantine first|Naltrexone 50mg memantine 20mg
16183654|NCT01519063|Drug|Naltrexone and Placebo first|Naltrexone 50 mg Placebo
16183655|NCT01519050|Behavioral|mitral valve repair|Mitral valve repair in patients with degenerative mitral regurgitation
16183656|NCT01519037|Drug|Cinacalcet 60 MG|one dose of oral cinacalcet, 60mg
16183657|NCT01519037|Drug|Placebo oral tablet|one tablet of placebo
16183658|NCT01519011|Drug|oral azacitidine|oral azacitidine 300-mg once daily for 3 total doses with two 150-mg tablets (fasted and fed) or three 100-mg tablets (fasted).
16183659|NCT01519011|Drug|oral azacitidine|300-mg (three 100-mg tablets) once daily for 21 days of a 28-day cycle.
16183701|NCT01518699|Drug|Ha44 Placebo|Ha44 Vehicle Gel without Abametapir
16183702|NCT01518699|Drug|Moxifloxacin Placebo|Moxifloxacin Placebo
16183660|NCT01518998|Drug|Fimasartan , Amlodipine, Placebo|Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination
16183661|NCT01518985|Drug|Bendavia|Bendavia for infusion Intravenous infusion (0.25mg/kg/hr) for 4 hours
16183662|NCT01518985|Drug|Sterile saline (0.9%)|Sterile saline for infusion (0.9%) Intravenous infusion for 4 hours
16183663|NCT01518985|Other|Cigarette smoking|One unfiltered cigarette will be smoked at approximately 30 minutes post-study-drug administration start.
16183664|NCT01518972|Drug|Prazosin|"Form: Prazosin will be taken orally, in the form of pills.
~Dosing: 9 AM, 3 PM, 9 PM
~Days 1-2: 0 mg, 0 mg, 1 mg
~Days 3-4: 1 mg, 1 mg, 1 mg
~Days 5-7: 2 mg, 2 mg, 2 mg
~Day 8-10: 2 mg, 2 mg, 6 mg
~Day 11-14: 4 mg, 4 mg, 6 mg
~Day 15-84: 4 mg, 4 mg, 8 mg"
16183665|NCT01518972|Drug|Placebo medication|"Form: Placebo will be taken orally, in the form of pills.
~Dosing: 9 AM, 3 PM, 9 PM
~Days 1-2: 0 mg, 0 mg, 1 mg
~Days 3-4: 1 mg, 1 mg, 1 mg
~Days 5-7: 2 mg, 2 mg, 2 mg
~Day 8-10: 2 mg, 2 mg, 6 mg
~Day 11-14: 4 mg, 4 mg, 6 mg
~Day 15-84: 4 mg, 4 mg, 8 mg"
16183666|NCT01518959|Drug|Cholecalciferol|180.000 IU monthly
16183667|NCT01518959|Drug|oleum neutralicum|Placebo comparator, 9 ml monthly
16183668|NCT01518946|Drug|Midodrine HCl|dose at the subject's current dose level
16183669|NCT01518946|Drug|Placebo|single dose of matching placebo
16183670|NCT01518933|Drug|Silibinin (Legalon-SIL)|20 mg/kg Silibinin (Legalon SIL), as per randomization schedule, will be administered daily as a 2-h infusion for 14 days.
16183671|NCT01518933|Drug|Saline|Placebo
16183672|NCT01518920|Drug|PF-04958242|PF-04958242 0.35 mg oral solution
16183673|NCT01518920|Drug|PF-04958242|PF-04958242 0.27 mg oral solution
16183674|NCT01518920|Drug|Placebo|Placebo oral solution
16183675|NCT01518907|Biological|COLLAGENASE CLOSTRIDIUM HISTOLYTICUM|Subdermal dose
16183676|NCT01518894|Drug|PF-04958242|PF-04958242 0.10 mg oral solution Q24 hours for 14 days
16183677|NCT01518894|Drug|PF-04958242|PF-04958242 0.20 mg oral solution Q24 hours for 14 days
16183678|NCT01518894|Drug|PF-04958242|PF-04958242 oral solution Q24 hours for 14 days (dose to be determined)
16183679|NCT01518894|Drug|Placebo|Placebo oral solution Q24 hours for 14 days
16183680|NCT01518881|Drug|TKM-100201|IV Infusion
16183681|NCT01518881|Drug|Placebo|IV infusion
16183682|NCT01518868|Device|Investigational contact lens|Worn on a daily wear basis for one week.
16183683|NCT01518868|Device|PureVision contact lens|Worn on a daily wear basis for one week
16183684|NCT01518855|Drug|Nifedipine (Adalat, BAYA1040)|
16183685|NCT01518855|Drug|Amlodipine (Norvasc)|
16183686|NCT01518855|Drug|Diovan|
16183687|NCT01518842|Biological|Intravitreal Bone Marrow Stem Cells|One intravitreal injection of a 0.1-ml cell suspension containing around 10x106 bone marrow mononuclear stem cells(BMMSC). All treatments were performed by a single retinal specialist using topical proparacaine drops under sterile conditions (eyelid speculum and povidone-iodine). Autologous BMMSC were injected into the vitreous cavity using a 27 gauge needle inserted through the inferotemporal pars plana 3.0 - 3.5 mm posterior to the limbus. After the injection, central retinal artery perfusion was confirmed with indirect ophthalmoscopy. Patients were instructed to instill one drop of 0.3% ciprofloxacin into the injected eye four times daily for 1 week after the procedure.
16183688|NCT01518803|Dietary Supplement|Mediterranean-style breakfast|"The experimental meal will be administered early in the morning as breakfast, Cardioliva olive oil, bread (2 slices), tomatoes (half piece), fruit juice (200 mL), skim milk (150 mL). The amount of fat administered will be the equivalent to 0.75 g per kg of body weight."
16183689|NCT01518803|Dietary Supplement|Western-style breakfast|The experimental meal will be administered early in the morning as breakfast, containing butter, bread 82 slices), chocolate milk (200 mL). The amount of fat administered will be the equivalent to 0.75 g per kg of body weight.
16183690|NCT01518790|Drug|polyethylene glycol 3350|PEG 3350 (238 grams) mixed with 1.9 L (64 oz) of Gatorade, given in 8 oz increments every 15-30 minutes until complete starting at 18:00 on day prior to colonoscopy (max time to completion 6 hours).
16183691|NCT01518777|Other|Half-dose isotope for NuclearStressTest|Half-dose of tracer or radioisotope will be used for Nuclear stress test of the heart. This is imaging test of the heart to see the function of arteries of the heart.
16183692|NCT01518764|Dietary Supplement|Red Wine Polyphenols 600mg/day|
16183693|NCT01518764|Dietary Supplement|placebo|
16183694|NCT01518738|Behavioral|breath attention training|4 week training
16183695|NCT01518738|Behavioral|working memory attention training|4 week training
16183696|NCT01518725|Dietary Supplement|Vitamin D|The vitamin D supplementation will consist of a capsule of 100 mcg of vitamin D/d, to be taken throughout the day. Participants will achieve 100 mcg by taking 2 x 25 mcg capsules per day. One will be taken at each time point (i.e., morning and evening) throughout the day. They will take the vitamin D supplement for the 6 month intervention period
16183697|NCT01518725|Dietary Supplement|Placebo|Participants in the placebo group will receive a capsule containing the inactive ingredients that include cellulose and silica to create a gel-like substance
16183698|NCT01518712|Drug|A (canagliflozin and metformin IR individual tablets) / B (canagliflozin/metformin IR FDC tablets)|Treatment A: Canagliflozin: Type = 1, unit = mg, number = 300, form = tablet, route = oral use + metformin IR: Type = 2, unit = mg, number = 850, form = tablet, route = oral use. One canagliflozin tablet and 2 metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 1 followed 10-15 days later by Treatment B (canagliflozin/metformin IR FDC): Type = 2, unit = mg, number = 150/850, form = tablet, route = oral use. Two canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 2
16183699|NCT01518712|Drug|B (canagliflozin/metformin IR FDC tablets / A (canagliflozin and metformin IR individual tablets)|Treatment B (canagliflozin/metformin IR FDC): Type = 2, unit = mg, number = 150/850, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 1 followed 10-15 days later by Treatment A: Canagliflozin: Type = 1, unit = mg, number = 300, form = tablet, route = oral use + Metformin IR: Type = 2, unit = mg, number = 850, form = tablet, route = oral use. One canagliflozin tablet and 2 metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 2.
16183700|NCT01518699|Drug|Ha44|Abametapir Lotion 0.74%
16183704|NCT01518686|Device|Octopus 900 perimeter (Haag Streit AG, Koeniz, Switzerland)|"We used the following six combinations of Goldmann8,1 stimulus size, stimulus luminance and angular velocity: V4e (64mm², 103', 320cd/m²) at 5°/s, III4e (4mm², 25.7', 320cd/m²) at 5°/s, I4e (0.25mm², 6.45', 320cd/m²) at 2°/s (for the assessment of the blind spot), I3e (0.25mm², 6.45', 100cd/m²) at 5°/s, I2e (0.25mm², 6.45', 32cd/m²) at 3°/s, I1e (0.25mm², 6.45', 10cd/m²) at 3°/s, I1a (0.25mm², 6.45', 4cd/m²) at 2°/s .
~The peripheral five isopters, consisting of 24 vectors (every 15° meridian), were presented in random order, while the innermost isopter (I1a) consisted of 12 vectors (every 30° meridian)"
16183705|NCT01518673|Procedure|Blood test|Analysing X-ray induced genetic effects in pediatric patients directly after a computer tomography scan.
16183706|NCT01518660|Behavioral|Training|Bi-weekly progressive resistance training
16183707|NCT01518647|Behavioral|Acceptance and Commitment Therapy|Acceptance and Commitment Therapy is a new third wawe cognitive therapy with the key treatment elements: acceptance, personal values and goals
16183708|NCT01518634|Drug|Imipramine treatment|Two-week of wash-out, one week of 10 mg study drug, 10 weeks of 25-75 mg study drug, four weeks of phasing-out and finaly two weeks after ther last dose of study drug to monito adverse events.
16183709|NCT01518634|Drug|Placebo|Two-week of wash-out, one week of 10 mg study drug, 10 weeks of 25-75 mg study drug, four weeks of phasing-out and finaly two weeks after ther last dose of study drug to monito adverse events.
16183710|NCT01518621|Radiation|Radiation|Whole brain radiation
16183711|NCT01518621|Drug|Radiation plus erlotinib|Radiation 3Gy x10 plus erlotinib 150 mg q d, from the day before radiation start, through last day of irradiation
16183712|NCT01518608|Drug|Alfentanil 0.5mg/ml (Rapifen , Janssen-Cilag)|"Induction dose(0µg/kg,10µg/kg,20µg/kg,30µg/kg,40µg/kg,50µg/Kg,and 60µg/kg) 12 patients in each dose group.
~Pentothal 4mg/kg Rocuronium 0.6 mg/kg"
16183713|NCT01518595|Drug|bosentan|pts. will receive bosentan for 3 months
16183714|NCT01518595|Drug|Placebo|pts. will receive placebo for 3 months
16183715|NCT01518582|Device|Cervical arthroplasty surgery with Granvia-C|Discectomy and Cervical arthroplasty according to standard practice of the surgeon
16183716|NCT01518569|Drug|ulinastatin|ulinastatin 5000 unit/kg iv before the initiation of CPB
16183717|NCT01518569|Drug|placebo|placebo (the same amount of normal saline) iv before the initiation of CPB
16183718|NCT01518556|Drug|Idarubicin|"In the phase I study, idarubicin dose is increased step by step as follows: 12 mg/m2/day for 3 days IV in the 1st step; 15 mg/m2/day for 3 days IV in the 2nd step; 18 mg/m2/day for 3 days IV in the 3rd step.
~In the phase II study, idarubicin dose is the maximum tolerated dose that is determined from the phase I study or 18 mg/m2/day for 3 days ."
16183719|NCT01518530|Device|Occiflex Robotic Intervention System|Occiflex is a robotic system which is comprised of a cradle moved in a three dimension space with six degrees of freedom. It allows the therapist to tailor a personalized course of 3-D mobilization of the head and neck.
16183720|NCT01518517|Drug|GRASPA|one injection of GRASPA 150 IU/kg at each cycle of chemotherapy
16183721|NCT01518517|Drug|L-asparaginase|3 to 4 Injections of Native E.coli asparaginase 10000IU/m² (every 3 days) at each cycle of chemotherapy
16183722|NCT01518504|Other|Thoracic Mobilization|The subject will be in a prone position and the physical therapist will first identify the upper thoracic spine region. The physical therapist will then cross his or her hands and place them on opposite sides of the spinous processes using the pisiforms as the contact area. The subject will be asked to exhale and upon exhalation the physical therapist will apply a small amplitude, quick thrust at end of range.
16183723|NCT01518504|Other|Sham|The subject will be in a prone position and the physical therapist will first identify the upper thoracic spine region. The physical therapist will then cross his or her hands and place them on opposite sides of the spinous processes using the pisiforms as the contact area. The subject will be asked to exhale and upon exhalation the physical therapist will not apply any other force than light hand contact.
16183724|NCT01518491|Drug|NanoDOX Hydrogel|NanoDOX Hydrogel will be applied three time weekly to the wound for eight weeks along with VAC therapy
16183725|NCT01518491|Other|VAC Alone|Patients will receive VAC therapy three time weekly for eight weeks
16183726|NCT01518478|Drug|Fluzone® Intradermal (Sanofi Pasteur Inc.)|"Fluzone® Intradermal trivalent vaccine is a clear-to-slightly opalescent, preservative-free suspension containing formaldehyde-inactivated split influenza viruses for intradermal delivery of 0.1 mL via an ultra-fine micro-needle. The vaccine is supplied as a single-dose, in a latex-free, pre-filled microinjection system. The active substance is prepared from influenza viruses propagated in embryonated chicken eggs.
~Fluzone® Intradermal is standardized according to United States Public Health Service (US PHS) requirements and is formulated to contain HA of each of the following three influenza strains recommended for the 2011-2012 influenza season: A/California/07/2009 X-179A (H1N1)-like virus, A/Perth/16/2009 (H3N2)-like virus, and B/Brisbane/60/2008-like virus."
16183727|NCT01518465|Drug|dalteparin|Given SC
16183728|NCT01518465|Drug|lenalidomide|Given PO
16183729|NCT01518465|Drug|dexamethasone|Given PO
16183730|NCT01518465|Other|laboratory biomarker analysis|Correlative studies
16183731|NCT01518452|Behavioral|Cogmed JM working memory training|daily training for 5 weeks on a computerized program for training working memory; a total of 25 training sessions. Program: Cogmed JM - preschool version of program: 15-20 minutes training per day
16183732|NCT01518452|Behavioral|Cogmed JM working memory training after waiting|Waiting after baseline testing for 8 weeks. Daily training on a computerized program for training working memory for 5 weeks. 25 training sessions in total. Program: Cogmed JM - preschool version of program: 15-20 minutes training per day
16183733|NCT01518439|Device|Alpha 200®|inspiratory capacity is increased with the use of constant pressure device: Alpha 200®
16183734|NCT01518439|Device|Alpha 200® + physiotherapist|inspiratory capacity is increased with the use of constant pressure device (Alpha 200®) combined with the manual pressures techniques to increase cough by the physiotherapist
16183735|NCT01518439|Device|Cough Assist®|increased inspiratory capacity and mechanical exsufflation with the use of insufflation-exsufflation device (Cough Assist®)
16183736|NCT01518439|Device|Cough Assist® + physiotherapist|increased inspiratory capacity and mechanical exsufflation with the use of insufflation-exsufflation device (Cough Assist®) combined with the manual pressures techniques to increase cough by the physiotherapist
16190747|NCT01466244|Other|immunohistochemistry staining method|
16183737|NCT01518439|Other|physiotherapist|manual pressures techniques to increase cough applied by the physiotherapist
16183738|NCT01518426|Device|EEG Recording (Emotiv)|"Record EEG during auditory oddball paradigms:
~with Emotiv EEG headset EMOTIV CAP (see http://www.emotiv.com)
~with 3 electrodes : 3 different types of electrodes at the time (needle, cupule 5mm, cupule 10mm)"
16183739|NCT01518413|Drug|sorafenib|sorafenib (50 and 200 mg tablets) orally twice daily, on a continuous schedule at a starting dose of 150mg/m2/dose.
16183740|NCT01518413|Drug|irinotecan|irinotecan (70 mg/m2/dose) orally, concurrently, once daily,starting at the beginning of the 21 day cycle,repeated every 21 days
16183741|NCT01518387|Drug|Lanthanum Carbonate (BAY77-1931)|
16183742|NCT01518374|Drug|Florbetapir F 18|370 MBq (10 mCi)
16183743|NCT01518348|Biological|Patch Test|Patch Tested with Gold sodium thiosulfate, 0.075 mg/cm2 in hydroxypropylcellulose · Hydrocortisone-17-butyrate, 0.020 mg/cm2 in polyvinylpyrrolidone· Methyldibromoglutaronitrile, 0.0053 mg/cm2 in polyvinylpyrrolidone·Bacitracin, 0.60 mg/cm2 in hydroxypropylcellulose· Parthenolide, 0.0030 mg/cm2 in polyvinylpyrrolidone· Disperse blue 106, 0.050 mg/cm2 in polyvinylpyrrolidone· Bronopol, 0.25 mg/cm2 in polyvinylpyrrolidone
16183744|NCT01518335|Procedure|Platelet rich plasma injection|50ml of blood drawn into a 60cc with 10cc of anticoagulant is processed using MAGELLAN® Autologous Platelet (Arteriocyte Medical Systems, Cleveland Ohio)to separate out approximately 3-6 cc of platelet rich plasma, which is mixed with 1 cc of 1 % Lidocaine (xylocaine) and 1 cc of 0.25 % Marcaine (bupivacaine) and injected into the site of injury under USG guidance.
16183745|NCT01518335|Procedure|Placebo Comparator: Placebo/Standard of Care|50ml of blood is drawn into a 60cc with 10cc of anticoagulant and is then discarded. 4 cc of saline solution is mixed with 1 cc of 1 % Lidocaine (xylocaine) and 1 cc of 0.25 % Marcaine (bupivacaine) and injected into the site of injury under USG guidance.
16183746|NCT01518322|Device|NIOX MINO®|Fractional Exhaled Nitric Oxide (FeNO) will be measured with the NIOX MINO®
16183747|NCT01518309|Drug|pimavanserin tartrate (ACP-103)|Tablets taken once daily by mouth at 20, 40, or 60 mg doses
16183748|NCT01518296|Device|Medtronic-Dantec Urodynamic System|Urodynamic test is test performed in order to assess whether there is a urinary incontinence and underlying cause. During this test the woman is asked to empty her bladder and then two transducers are inserted, one into the bladder and the other into the rectum, then the bladder is filled with physiological solution and the patient is asked to urinate. During bladder emptying urinary flow velocity is measured and the pressures in the abdomen and bladder are recorded for later evaluation
16183749|NCT01518283|Drug|Cabazitaxel 10 mg/m2|Cabazitaxel 10 mg/m2 in a 1-hour infusion on days 1, 8, 15 and 22 of 5-week cycles.
16183750|NCT01518270|Other|No treatment|No treatment will be provided
16183751|NCT01518257|Biological|botulinum toxin Type A|A single 200U (2 mL) dose of botulinum toxin Type A injected into the intra-articular space of the study knee on Day 1.
16183752|NCT01518257|Drug|Normal Saline|A single 2 mL dose of Normal Saline (placebo) injected into the intra-articular space of the study knee on Day 1.
16183753|NCT01518244|Drug|Brinzolamide/timolol maleate fixed combination|
16183754|NCT01518231|Procedure|autologous hematopoiesis stem cell transplantation|Every participant will be transplanted with about 4 million autologous peripheral blood stem cell(CD34+) through cerebral artery.
16183755|NCT01518231|Drug|Aspirin|aspirin 100mg,qd,po(patients with no fibrillation atrial)
16183756|NCT01518231|Drug|Warfarin|warfarin 2~6mg,qd,po(patients with fibrillation atrial);
16183757|NCT01518231|Drug|Atorvastatin|atorvastatin 20mg,qd,po
16183758|NCT01518231|Drug|Edaravone|edaravone 30mg,bid,ivgtt.
16183759|NCT01518231|Drug|Aspirin|aspirin 100mg,qd,po(patients with no fibrillation atrial)
16183760|NCT01518231|Drug|Warfarin|warfarin 2~6mg,qd,po(patients with fibrillation atrial)
16183761|NCT01518231|Drug|Atorvastatin|atorvastatin 20mg,qd,po
16183762|NCT01518231|Drug|Edaravone|edaravone 30mg,bid,ivgtt
16183763|NCT01518218|Behavioral|laying-on-of-hands|The intervention group received laying-on-of-hands every weekday for 1 year along with conventional medicine. The control group did not undergo any alternatives to OPT.
16183764|NCT01518205|Device|LDL-apheresis|"The patient of the Arm LDL-apheresis in addition to standard therapy, will undergo a cycle of LDL-apheresis.
~LDL-apheresis will be performed with B.Braun Avitum H.E.L.P. System. Apheretic treatment scheme: 10 apheretic sessions carried out as follows: the first 2 with a 3 day distance (i.e. 2 treatments in one week), successively 1 session per week (every 7 days).
~To perform the treatment, the forearm surface veins will be punctured by means of 17 Ga needles, as an alternative a two-ways CVC will be used."
16183765|NCT01518192|Drug|doxycycline|100 mg bid; 15 days
16183766|NCT01518192|Drug|cefuroxime axetil|500 mg bid; 15 days
16183767|NCT01518179|Device|Made-to-Measure Compression Gloves|Made-to-Measure Compression Gloves in addition to routine follow up and treatment.
16183768|NCT01518179|Other|Routine follow up and treatment|Control
16183769|NCT01518166|Drug|liraglutide|Administered as a subcutaneous injection. Initial dose 0.6 mg daily, adjusted to 1.2 mg daily in week 2 and escalated to 1.8 mg daily in week 3
16183770|NCT01518166|Drug|placebo|Administered as a subcutaneous injection. Given as daily volume of 100 mcl, 200 mcl and 300 mcl respectively
16183771|NCT01518166|Drug|atorvastatin|One single dose of 40 mg. Tablet
16183772|NCT01518166|Drug|lisinopril|One single dose of 20 mg. Tablet
16183773|NCT01518166|Drug|griseofulvin|One single dose of 500 mg. Tablet
16183774|NCT01518166|Drug|digoxin|One single dose of 1 mg. Tablet
16183775|NCT01518153|Drug|Fludarabine|40 mg/m^2 by vein on Day -6 to -3.
16183776|NCT01518153|Drug|Melphalan|140 mg/m^2 by vein on Day -2.
16183777|NCT01518153|Drug|Alemtuzumab|50 mg by vein on Day -1.
16183778|NCT01518153|Procedure|Stem Cell Infusion|Reduced intensity stem cell transplant on Day 0.
16183779|NCT01518153|Drug|Tacrolimus|0.015 mg/kg by vein as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml (target is 10 ng/ml). Tacrolimus is changed to oral dosing when tolerated. Tapering should start on approximately Day +24 with intention to be completely off drug by approximately Day +35.
16183780|NCT01518153|Drug|Methotrexate|5 mg/m2 dosed based on actual body surface area and administered intravenously on days +1, +3, +6.
16183832|NCT01517763|Device|Conventional CPAP Therapy|HC244 devices without Thermosmart or SensAwake
16183781|NCT01518153|Drug|G-CSF|5 mcg/kg/day subcutaneously beginning on Day +7, and continuing until absolute neutrophil count (ANC) is > 500 * 10/L for 3 consecutive days.
16183782|NCT01518153|Procedure|Low Dose Donor T-Cells|Planned Donor Lymphocyte Infusion CD3+ cells: 3 * 106 CD3+ cells/kg between Day +56 and +64.
16183783|NCT01518153|Procedure|High Dose Donor T-Cells|Planned Donor Lymphocyte Infusion CD3+ cells: 1 * 107 CD3+ cells/kg between Day +56 and +64.
16183784|NCT01518140|Device|Oxygen Delivery Devices|"Participants receive air through VapoTherm for 1 hour, and then on an as needed basis for up to 4 hours. Participants then receive air through bilevel positive airway pressure (BiPAP) for up to 30 minutes, followed by 30 minutes using non-rebreather mask."
16183785|NCT01518140|Behavioral|Questionnaires|2 Questionnaires completed at baseline taking about 10 minutes to complete. At end of visit, questionnaire completion taking about 5 minutes to complete.
16183786|NCT01518127|Other|intravitreal injection of autologous bone marrow stem cells|intravitreal injection of autologous bone marrow stem cells
16183787|NCT01518114|Behavioral|Exercise Training|Exercise will be performed under continuous telemetry monitoring and medical supervision. Each session will include 5-10 worm-up, 30 min of aerobic activity on treadmill or bicycle ergometer followed by 10-15 min of stretch and relaxation exercise. Blood pressure will be obtained before the onset and at the end of each session. Participants will be requested to rest and observed 15-30 min before going home. The exercise intensity will be monitored and adjusted, per protocol, according to RPE using the Borg scale.
16183788|NCT01518101|Drug|Vildagliptin/ Metformin|Single pill combination of Vildagliptin/ Metformin (50/1000 mg).
16183789|NCT01518101|Drug|Liraglutide|1.2 mg once daily by commercially available injection pens
16183790|NCT01518101|Drug|Metformin|1000 mg tablets twice daily
16183791|NCT01518088|Dietary Supplement|Dietary Fiber|Dietary fiber will be added to study foods
16183792|NCT01518075|Other|Spontaneous Breathing|"Evaluation of breathing - swallowing interaction without non invasive mechanical ventilation. Patient breath spontaneously.
~Measurements of respiratory and swallowing parameters were monitored using respiratory inductive plethysmography. Swallowing was monitored noninvasively. Two bolus sizes were used, (5, 10 ml), in random order. Five sets of two boluses were studied, taking care not to use the same bolus size twice consecutively. The study participants were blinded to bolus size."
16183793|NCT01518075|Other|Non Invasive Mechanical Ventilation|Evaluation of breathing - swallowing interaction with non invasive mechanical ventilation. Patient breath under non invasive mechanical ventilation. Measurements of respiratory and swallowing parameters were monitored using respiratory inductive plethysmography. Swallowing was monitored noninvasively. Two bolus sizes were used, (5, 10 ml), in random order. Five sets of two boluses were studied, taking care not to use the same bolus size twice consecutively. The study participants were blinded to bolus size.
16183794|NCT01518062|Drug|somatropin|4 IU/m^2 body surface for 4 years (main period). In extension period subjects continue the reached dose until final height. Administered as once daily subcutaneous injection
16183795|NCT01518062|Drug|somatropin|Initial dose 4 IU/m^2 body surface the first year, then 6 IU/m^2 body surface for 3 years (main period). In extension period subjects continue the reached dose until final height. Administered as once daily subcutaneous injection
16183796|NCT01518062|Drug|somatropin|Initial dose 4 IU/m^2 body surface the first year, then 6 IU/m^2 body surface, the second year and finally 8 IU/m^2 body surface for 2 years (main period). In extension period subjects continue the reached dose until final height. Administered as once daily subcutaneous injection
16183797|NCT01518062|Drug|oestrogen|Treatment with oestrogen was administered if spontaneous puberty had not occurred by age 12 years and was initiated in the extension period after at least four years of somatropin treatment
16183798|NCT01518036|Drug|somatropin|2.9 IU/m^2/day. Administered as once daily subcutaneous injection until final height is reached
16183799|NCT01518036|Drug|somatropin|4.3 IU/m^2/day. Administered as once daily subcutaneous injection until final height is reached
16183800|NCT01518023|Other|Interview, questionnaire, updated biochemical tests|Patients will be interviewed and questioned about nutritional status, diet, drugs and diagnosis/clinical course of diabetes. Routine biochemical tests will be searched and if necessary updated.
16183801|NCT01518010|Behavioral|Play game|Participants engage in non-game activity (establish baseline) 7 * 1 hr weekly; play single-player game 7 * 1 hr weekly; play multi-player game 7 * 1 hr weekly.
16183802|NCT01517997|Procedure|Paclitaxel coated balloon angioplasty.|Infrapopliteal angioplasty using a paclitaxel coated balloon.
16183803|NCT01517997|Procedure|Infrapopliteal Primary Drug Eluting Stenting|Infrapopliteal primary stenting using drug-eluting stent(s)
16183804|NCT01517984|Drug|Tacrolimus (CNI) Withdrawal|"Recipients of living-donor kidney allografts are given induction therapy with rabbit antithymocyte globulin (RATG, Thymoglobulin®) and treated with a regimen of mycophenolate mofetil (MMF), prednisone and tacrolimus.
~Subjects without any clinical acute rejection (AR) in the first 6 months, without borderline or acute rejection on the 6 month biopsy, and without donor-specific antibody (DSA) at anytime, including the 6 month test will be randomized (2:1) to tacrolimus (CNI) withdrawal."
16183805|NCT01517984|Drug|Standard Immunosuppressive Therapy|Recipients of living-donor kidney allografts are given induction therapy with rabbit antithymocyte globulin (RATG, Thymoglobulin®) and treated with a regimen of mycophenolate mofetil (MMF), prednisone and tacrolimus.
16183806|NCT01517971|Other|laboratory biomarker analysis|Correlative studies
16183807|NCT01517958|Other|Respiratory Distress Group|Diagnostic lung ultrasound.
16183808|NCT01517958|Other|Control Group|Lung ultrasound
16183809|NCT01517945|Behavioral|AIM materials and assessments|Phase 1 - dev of AIM materials and assessments that target fear of cancer recurrence via feedback from BCS (n = 10). Phase 2 - randomized, single-blind, placebo-controlled, proof-of-concept pilot trial. Phase 3 - 3 parts. Part 1 of Phase 3, clickable prototype of the iThrive app will be created. Part 2, usability testing of the app by observing timing and navigation with BCS in a laboratory setting will be completed. Part 3, acceptability of the iThrive app will be assessed by conducting a small RCT (n=30). Phase 4 - 3 parts. Part 1 of Phase 4, clickable prototype of the iThrive app will be created. In Part 2, usability testing of the app will be completed by observing timing and navigation with RCS either in person or remotely. In Part 3, acceptability of the iThrive app will be assessed by conducting a small RCT (n=90).
16183877|NCT01517399|Drug|digoxin|One oral 0.25 mg tablet once alone and once again with tivantinib
16183810|NCT01517932|Drug|dexmedetomidine|"In this arm,midazolam(0.03-0.05mg/kg), propofol(1.5-2.5mg/kg),sufentanil(0.6-0.82μg/kg )and rocuronium(0.8-1.0mg/kg) were used in anesthesia induction.
~Anaesthesia was maintained with propofol（4-6mg kg-1h-1），remifentanil (0.1-0.2 μg kg-1 min-1）and sevoflurane（1%).Propofol was titrated to maintain intraoperative Narcotrend values between 20 and 46.
~Patients in this arm received dexmedetomidine 0.2μg/kg i.v. during 10 minutes 1 hour before the end of surgery"
16183811|NCT01517932|Drug|saline placebo|"In this arm,midazolam(0.03-0.05mg/kg), propofol(1.5-2.5mg/kg),sufentanil(0.6-0.82μg/kg )and rocuronium(0.8-1.0mg/kg) were used in anesthesia induction.
~Anaesthesia was maintained with propofol（4-6mg kg-1h-1），remifentanil (0.1-0.2 μg kg-1 min-1）and sevoflurane（1%).Propofol was titrated to maintain intraoperative Narcotrend values between 20 and 46.
~Patients in this arm received saline placebo of the same volume i.v. during 10 minutes 1 hour before the end of surgery"
16183812|NCT01517919|Behavioral|Peer-Led Self-Management|"The PLSM intervention is designed to improve and sustain participants' self-management and health-related gains associated with type 2 diabetes. The role of peer leaders is to provide support for (1) ongoing self-management efforts (including the 5-step action-planning process), (2) psychosocial and emotional adjustment, and (3) linkage to needed health care resources.
~PLSM intervention will consist of three main components provided by the Peer Leaders: weekly self-management support sessions; outreach telephone contacts and inbound telephone call from participants."
16183813|NCT01517906|Behavioral|Identity Intervention Program|Cognitive behavioral strategies will be used by trained nurse-therapists to facilitate the participant's: a) identification of a small collection of personally meaningful and feasible desired possible selves, b) prioritization of the desired possible selves as short and long-term goals, c) identification, elaboration, implementation and evaluation of cognitive and behavioral strategies to achieve the desired possible self selected as the goal, and d) identification of internal and external barriers that interfere with achieving the possible self goal and utilization of active problem solving strategies to overcome the barriers.
16183814|NCT01517906|Behavioral|Supportive Psychotherapy for the Eating Disorders|SPI is a 20-week program with a one-hour individual psychotherapy session scheduled each week. The SPI is organized in three stages: 1) Stage 1 (Sessions 1-8) including assessment of the current and past ED history, collection of personal and family history, and identification of problems contributing to the ED; 2) Stage 2 (Sessions 9-16) aims include exploration of underlying emotional problems, increased self-disclosure and expression of feelings, and fostering independence; and 3) Stage 3 (Sessions 17-20) includes continued exploration of underlying problems and implications for future behaviors and termination.
16183815|NCT01517893|Drug|Simvastatin|Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated
16183816|NCT01517893|Drug|Placebo|Sig: 40 mg PO daily for 1 month, increased to 80 mg PO daily for 5 months if low dose tolerated
16183817|NCT01517880|Drug|Sialic Acid Extended Release (SA-ER)|SA-ER will be administered in doses of 3000mg per day or 6000mg per day
16183818|NCT01517880|Drug|Placebo|Subjects will be randomized to the placebo arm for the first 24 weeks of the study. Then, subjects in this arm will be re-randomized into either the 3,000 mg per day or 6,000 mg per day arm for the remaining 24 weeks of the study (total study duration 48 weeks).
16183819|NCT01517867|Behavioral|Chicago Parent Program|The Chicago Parent Program is a 12-session group-based parenting skills intervention for parents of young children with behavior problems
16183820|NCT01517867|Behavioral|Parent-Child Interaction Therapy|Parent-Child Interaction Therapy is an individually-tailored coaching intervention for parents and young children with behavior problems
16183821|NCT01517854|Drug|Sildenafil|20 mg Revatio (sildenafil citrate) three times a day
16183822|NCT01517854|Drug|Placebo|Placebo identical to Revatio (sildenafil citrate) three times a day
16183823|NCT01517828|Drug|Sedation by ketamine|"Kétamine (50mg/5ml, Panpharma): for a posology of 2 mg/kg: dose of 0.2 ml/kg Intranasal administration with a 1 ml syringe. Kétamine is a derivated of phencyclidine with a sedative, anesthesic, analgesic and amnesiant activity. Ketamine keeps also a protective reflex of upper respiratory tracts.
~One injection will be done and if after 7 minutes, newborn is not correctly sedated another dose of same product will be done."
16183824|NCT01517828|Drug|Sedation with Midazolam|"Midazolam (phyal of 5mg/5ml, Mylan S.A.S.) for a posology of 0.2 mg/kg: dose of 0.2 ml/kg Instillation in intranasal with a syringe of 1 ml. Midazolam is an imidazobenzodiazépine, witj a sedative and hypnotic activity,anxiolytic, anti convulsive and muscle relaxant proprieties.
~One injection will be done and if after 7 minutes, newborn is not correctly sedated another dose of same product will be done."
16183825|NCT01517815|Drug|Doripenem or Piperacillin/Tazobactam|"This arm is composed of 26 no overweight patients, Antibiotic (Doripenem or Piperacillin/Tazobactam) is chosen by the intensivist in charge of the case:
~in 13 no overweight patients, Pipéracilline/tazobactam will be administered in 4g IV (1h) and then 16g/24h IV continuously. Piperacillin/Tazobactam plasma dosage: after the first dose and then every 12h.
~in 13 patients no overweight: doripénème will be administered in 1g/8h with a 4h IV infusion. Doripenem plasma dosage: after the first dose and then twice a day, at peak and residual value."
16183826|NCT01517815|Drug|Doripenem or Piperacillin/Tazobactam|"This arm is composed of 26 overweight patients, Antibiotic (Doripenem or Piperacillin/Tazobactam) is chosen by the intensivist in charge of the case:
~in 13 overweight patients, Pipéracilline/tazobactam will be administered in 4g IV (1h) and then 16g/24h IV continuously. Piperacillin/Tazobactam plasma dosage: after the first dose and then every 12h.
~in 13 patients overweight: doripénème will be administered in 1g/8h with a 4h IV infusion. Doripenem plasma dosage: after the first dose and then twice a day, at peak and residual value."
16183827|NCT01517802|Drug|Abiraterone acetate|Type=exact number, unit=mg, number=1000, form=tablet, route=oral, abiraterone acetate once daily
16183828|NCT01517802|Drug|Prednisone|Type=exact number, unit=mg, number=5, form=tablet, route=oral, prednisone or prednisolone twice daily
16183829|NCT01517789|Device|Visual evoked potentials monitoring during neurosurgery - Vision monitor MonOpera®|"Visual assessment (visual field, visual acuity, pattern visual evoked potential) are realised before and after surgery.
~Flash and steady state visual evoked potential are measured during the surgical procedure at different times."
16183830|NCT01517776|Drug|Cilengitide|Cilengitide 1800 mg/m² i.v. twice weekly with a mandatory platelet-count dependent dose adaptation rule
16183831|NCT01517776|Drug|Temozolomide|Temozolomide 75 mg/m²/d p.o. for 6 weeks, followed by 1 week rest with a mandatory platelet-count dependent dose adaptation rule
16183833|NCT01517763|Device|Fixed pressure ICON™ without ThermoSmart™|Fixed pressure CPAP therapy using ICON™ without ThermoSmart™ or SensAwake™
16183834|NCT01517763|Device|Auto ICON™ with SensAwake™ and ThermoSmart™|APAP therapy using Auto ICON™ with SensAwake™ and ThermoSmart™
16183835|NCT01517750|Device|ICON Auto CPAP™ with Thermosmart heated tube|ICON Auto CPAP™ with heated humidification and the use of a heated tube
16183836|NCT01517750|Device|ICON Auto CPAP™ without Thermosmart heated tube|ICON Auto CPAP™ without heated humidification or the use of a heated tube.
16183837|NCT01517724|Drug|Bortezomib|1.3mg/sq m, subcutaneous injection, days 1, 8, 15 and 22 of 28 day cycle; maximum of 8 cycles
16183838|NCT01517711|Drug|Tramadol|Tramadol hydrochloride Extended Release(ER) will be supplied as tablets of Ultram® ER 100mg. Tramadol ER (100-300mg) or matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).
16183839|NCT01517711|Drug|Placebo|Matching placebo will be self-administered by oral route every morning (with or without food) for 6 weeks. Patients will be instructed to take it the same way (either with food or without food) each time they take their dose. Each patient will be provided with 1 week supply of Tramadol ER or matching placebo on visits 2 (week 0) and 3 (week 1) and 2 weeks supply on visits 4 (week 2) and 5 (week 4).
16183840|NCT01517698|Drug|Placebo|placebo to RO4917523 orally once a day for 12 weeks
16183841|NCT01517698|Drug|RO4917523 0.5 mg|0.5 mg orally once a day for 12 weeks
16183842|NCT01517698|Drug|RO4917523 1.5 mg|1.5 mg orally once a day for 12 weeks
16183843|NCT01517685|Dietary Supplement|Organic flax seed oil|2 tablespoons of organic flax seed oil are eaten daily for 8 weeks.
16183844|NCT01517685|Dietary Supplement|fish oil|5 grams (1 tsp.) of fish oil is eaten per day for 8 weeks.
16183845|NCT01517672|Behavioral|Cognitive Trauma Therapy for Battered Women (CTT-BW)|10 individual sessions of this form of cognitive therapy, with a trained therapist.
16183846|NCT01517659|Device|The Zeltiq CoolSculpting System|Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
16183847|NCT01517646|Device|The Zeltiq System|Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
16183848|NCT01517633|Device|BirthSign|When leakage from the vagina occurs, the woman will wet the indicator lines of the device with the body fluids.
16183849|NCT01517620|Drug|Total Glucosides Paeony Capsules|Total Glucosides Paeony Capsules, oral, 0.3 gram per capsule, 3 capsules tid, 24 weeks
16183850|NCT01517607|Other|Mesalazine|Patient's treated with oral Mesalazine
16183851|NCT01517568|Drug|liraglutide [3H]|A single dose of 0.75 mg will be given as a subcutaneous injection
16183852|NCT01517555|Drug|liraglutide|Administered as a subcutaneous injection. Initial dose 0.6 mg daily, adjusted to 1.2 mg daily in week 2 and escalated to 1.8 mg daily in week 3
16183853|NCT01517555|Drug|placebo|Administered as a subcutaneous injection. Given as daily volume of 100 mcl, 200 mcl and 300 mcl respectively
16183854|NCT01517555|Drug|paracetamol|One single dose of 1 g. Tablet
16183855|NCT01517542|Other|Nutritional Counseling|2 groups: 1 with nutritional counseling and other with usual diet without nutritional counseling
16183856|NCT01517503|Behavioral|Cognitive Therapy|This interventions will target: (a) behavioral dysfunction, (b) situation-specific negative thinking and cognitive distortions, and (c) underlying dysfunctional beliefs or cognitions assumed to be related to the patient's current depression and risk of future depression. A maximum of 20 45-55 minute sessions will be provided, with sessions generally held weekly for the first 8 sessions and once every two weeks for the next 8 sessions.
16183857|NCT01517503|Behavioral|Acceptance and Commitment Therapy|This interventions will use (a) acceptance, (b) commitment, (c) mindfulness, and (d) behavior change processes to produce reduction of depressive symptoms. A maximum of 20 45-55 minute sessions will be provided, with sessions generally held weekly for the first 8 sessions and once every two weeks for the next 8 sessions.
16183858|NCT01517490|Other|Insulin pump|Insulin pump therapy
16183859|NCT01517490|Other|Multiple daily insulin injections|Multiple daily insulin injections
16183860|NCT01517490|Procedure|Bariatric surgery|Pre-operative weight loss and bariatric surgery.
16183861|NCT01517490|Other|Medical therapy for type 2 diabetes|Medical glucose-lowering therapy and non-surgical weight-lowering interventions.
16183862|NCT01517477|Device|iStent|Implantation of One iStent through a small temporal clear corneal incision.
16183863|NCT01517477|Device|iStent|Implantation of Two iStents through a small temporal clear corneal incision
16183864|NCT01517477|Device|iStent|Implantation of Three iStents through a small temporal clear corneal incision
16183865|NCT01517464|Genetic|SGT-94|SGT-94 will be given at doses of 0.6, 1.2, 2.4, 3.6 and 4.8 mgDNA/infusion(Doses 0-5, respectively)twice weekly for 3 weeks out of 4 in dose levels 0 to 4, and for 5 weeks out of 6 for dose level 5 (also 4.8mg DNA). Intravenous infusion will occur over 1 to 2.5 hours in 5% dextrose,with a final volume of SGT-94 and dextrose of 100 mL to 250 mL, depending on dose level.
16183866|NCT01517451|Radiation|Radiation Therapy|7.25 Gy every other day fractions to a total dose of 36.25 Gy (total of 5 fractions)
16183867|NCT01517451|Drug|Androgen Deprivation Therapy (ADT)|Androgen deprivation therapy (ADT) for 4 months total, greater than or equal to 1 month prior to SBRT.
16183868|NCT01517438|Behavioral|agitation|agitation score after desflurane anesthesia
16183869|NCT01517412|Drug|Lixisenatide (AVE0010)|Pharmaceutical form: Solution for injection; Route of administration: Subcutaneous
16183870|NCT01517412|Device|Self-injector pen device (OptiClik®)|
16183871|NCT01517412|Drug|Metformin|To be kept at stable dose (≥1.5 g/day) throughout the study.
16183872|NCT01517399|Drug|tivantinib|three oral 120 mg tablets administered twice a day
16183873|NCT01517399|Drug|omeprazole|One 40 mg oral capsule once alone and once again with tivantinib
16183874|NCT01517399|Drug|s-warfarin|One 10 mg oral tablet once alone and once again with tivantinib
16183875|NCT01517399|Drug|caffeine|One 200 mg oral tablet once alone and once again with tivantinib
16183876|NCT01517399|Dietary Supplement|vitamin K|One oral 5 mg tablet on multiple days when and around warfarin administration
16183878|NCT01517399|Drug|midazolam|Intravenous 1.5 mg dose once alone and once again with tivantinib
16183879|NCT01517386|Procedure|thoracic surgery|unilateral thoracic surgery under paravertebral block and general anesthesia
16183880|NCT01517373|Drug|Placebo|Combination of tablets and capsules, a total of 3 pills/dose, administered once daily for 84-days
16183881|NCT01517373|Drug|PF-04937319 10 mg|Combination of tablets and capsules, dose of 10 mg, a total of 3 pills/dose, administered once daily for 84-days
16183882|NCT01517373|Drug|PF-04937319 50 mg|Combination of tablets and capsules, dose of 50 mg, a total of 3 pills/dose, administered once daily for 84-days
16183883|NCT01517373|Drug|PF-04937319 100 mg|Combination of tablets and capsules, dose of 100 mg, a total of 3 pills/dose, administered once daily for 84-days
16183884|NCT01517373|Drug|Glimepiride|Combination of tablets and capsules, dose of up to 6 mg, a total of 3 pills/dose, administered once daily for 84-days
16183885|NCT01517360|Drug|Oxytocin|Oxytocin 40 IU, intranasal inhalation
16183886|NCT01517360|Other|Placebo|Placebo, matched to Oxytocin, intranasal inhalation
16183887|NCT01517360|Behavioral|Social Cognitive Skills Training|The training utilizes skill building techniques that are commonly used in psychiatric rehabilitation. These include breaking down complex social cognitive processes into their components and automating these skills through repetition and practice. The training programs will include 12 sessions and will be administered in a small group format (6-8 participants per group) twice a week for 6 weeks. Each training session will last for about 90 minutes (1 hour training and 30 minutes between drug administration and start of training).
16183888|NCT01517347|Drug|Interleukin-2|Patients receive low dose interleukin-2(Daily 1×106 IU per square meter of body-surface area) on days 60 after unmanipulated blood and marrow transplantation. Interleukin-2 treatment repeats every 14 days for 6 courses in the absence of disease progression or unacceptable toxicity.
16183889|NCT01517334|Drug|Minocycline HCl Microspheres|
16183890|NCT01517321|Drug|MK-0431/ONO-5435|Double-blind period (12 wk); 50 mg QD. The double-blind period will be followed by a 40 week open label extension period where MK-0431/ONO-5435 could be titrated from 50 mg to 100 mg QD.
16183891|NCT01517321|Drug|Placebo, MK-0431/ONO-5435|Double-blind period (12 wks); placebo QD. The double-blind period will be followed by a 40 wk open label extension period where MK-0431/ONO-5435 could be titrated from 50 mg to 100 mg QD.
16183892|NCT01517308|Drug|pegylated interferon alpha 2a + ribavirin|Comparison of different duration of drugs (48 weeks vs. 24 weeks)
16183893|NCT01517295|Drug|Hydrocodone|Dose: Standard prescribed dose Frequency: Once Duration: Once
16183894|NCT01517282|Biological|MOR103|Anti-GM-CSF monoclonal antibody
16183895|NCT01517282|Other|Placebo|Placebo to anti-GM-CSF monoclonal antibody
16183896|NCT01517269|Behavioral|Parent education with human patient simulator|After child is newly diagnosed with Type 1 diabetes, parents will receive 3 teaching sessions over 12 weeks, after baseline data collected, at 1 month, and at 3 months, covering hypoglycemia, hyperglycemia and pattern management using teaching vignettes and practice with human patient simulator
16183897|NCT01517269|Behavioral|Standard care|After child is newly diagnosed with Type 1 diabetes, parents will receive 3 teaching sessions over 12 weeks, after baseline data collected, at 1 month, and at 3 months, covering hypoglycemia, hyperglycemia and pattern management without the use of a simulator
16183898|NCT01517256|Behavioral|Living Everyday Above-and-beyond Pain (LEAP)|8-week multidisciplinary group therapy aiming consisting of education about the nature of chronic pain, pacing and goal setting, mindfulness medication techniques, cognitive reflections on beliefs, impulses and obsessions, physical activation, and medication management.
16183899|NCT01517256|Other|Wait-listed|Patients are wait-listed while awaiting participation to the LEAP program.
16183900|NCT01517243|Drug|Sunitinib|Sunitinib 50mg by mouth daily for 4 weeks followed by a two week rest
16183901|NCT01517243|Drug|Temsirolimus|Temsirolimus 25mg IV weekly for 4 weeks followed by a two week rest
16183902|NCT01517230|Behavioral|Local radio campaign to reduce under-five child mortality|"The media campaign is designed by Development Media International. It includes short spots and long format programs broadcast by rural community radios. Major topics to be addressed include: diarrhoea, water and sanitation, acute respiratory infections, fever/malaria, antenatal consultations, delivery in health facilities, breastfeeding, and child nutrition. The intervention is planned to start in March 2012 after completion of fieldwork for the baseline survey and will continue for 2.5 years."
16183903|NCT01517217|Procedure|No girdle|No girdle is used for the first five postoperative days
16183904|NCT01517217|Procedure|Girdle|Girdle the first five postoperative days
16183905|NCT01517204|Device|Direct laryngoscope (Macintoish laryngoscope)|Direct laryngoscope was used to facilitate the intubation of left-sided DLT.
16183906|NCT01517204|Device|Trachway(R) intubating stylet|Trachway(R) intubating stylet was used to facilitate the intubation of left-sided DLT.
16183907|NCT01517178|Device|New ostomy base plate (SS)|The base plate is applied to the skin around the stoma and an ostomy bag is clicked onto the base plate.
16183908|NCT01517178|Device|Standard Care base plate|The base plate is applied to the skin around the stoma and an ostomy bag is clicked onto the base plate.
16183909|NCT01517165|Drug|Pioglitazone|
16183910|NCT01517165|Drug|Placebo|
16183915|NCT01517074|Drug|Sirolimus|Subconjunctival injection
16183916|NCT01517035|Procedure|Stem Cell Transplantation|Myeloablative conditioning (Flu/Cy/TBI) followed by CD3/19/34 selected stem cell graft.
16183917|NCT01517022|Drug|nicotine replacement therapy|nicotine replacement therapy 2mg for patients cessation arm for period of 6 weeks
16183918|NCT01517009|Drug|Docetaxel|60 mg/m2, 1 gift every 3 weeks, in total 4 gifts
16183919|NCT01517009|Drug|cisplatin|60 mg/m2, one gift every three weeks, in total 4 gift
16183920|NCT01517009|Drug|Capecitabine|1875 mg/m2 in two equally divided doses day 1-14, repeated every three weeks, in total 4 cycles
16183921|NCT01517009|Procedure|D1extra-resection|An extended lymphadenectomy compared to a D1 resection for gastric cancer
16183922|NCT01516996|Drug|docetaxel and cisplatin|"The neoadjuvant consists of docetaxel 75mg/m2 day 1 and cisplatin 75mg/m2 days 1 to 3, repeat every 3 weeks, for 2 cycles.
~CCRT: cisplatin 75mg/m2 is administered on day 1 of week 7,10 and 13 on current with RT"
16183923|NCT01516996|Radiation|IMRT|"IMRT is administered with chemotherapy from week 7 to week 13
~GTV（primary tumor）：68-70Gy/35~38 F，once a day, 5 times per week
~CTV（Clinical target）：56-66Gy/30~36f，once a day, 5 times per week
~GTV-ln（positive neck region）：66-70Gy/33~36 F，once a day, 5 times per week
~CTV-ln（negative neck region）：50-54Gy/28~30F, once a day, 5 times"
16183924|NCT01516996|Biological|Nimotuzumab|Nimotuzumab was administered 200 mg IV over 1 hour on day 1,once a week, for 13~14 weeks
16183925|NCT01516983|Drug|icotinib|"Level 1: Standard whole brain radiation therapy plus icotinib 125 mg Tid (375 mg per day) from day1 until disease progression or intolerable toxicity.
~Level 2: Standard whole brain radiation therapy plus icotinib 250 mg Tid (750 mg per day) from day1 until disease progression or intolerable toxicity.
~Level 3: Standard whole brain radiation therapy plus icotinib 375 mg Tid (1125 mg per day) from day1 until disease progression or intolerable toxicity.
~Level 4:Standard whole brain radiation therapy plus icotinib 500 mg Tid (1500 mg per day) from day1 until disease progression or intolerable toxicity."
16183926|NCT01516983|Radiation|Whole brain radiotherapy|Whole Brain Radiation Therapy (WBRT) for total dose of 37.5Gy in 15 daily fractions beginning after Day 7.
16183927|NCT01516970|Drug|Darunavir/Ritonavir (DRV/r)|Darunavir (DRV) type=exact number, unit=mg, number=800, form=tablet, route=oral use. Tablet is taken once a day, for 28 days; Ritonavir (r) type=exact number, unit=mg, number=100, form=tablet, route=oral use. Tablet is taken once a day, for at least 28 days and a maximum of 30 days.
16183928|NCT01516970|Drug|Lopinavir in fixed combination with Ritonavir|type=exact number, unit=mg, number=400/100, form=tablet, route=oral use. Tablet is taken once or twice a day, for at least 28 days and a maximum of 30 days.
16183929|NCT01516970|Drug|Zidovudine|type=exact number, unit=mg, number=250, form=tablet, route=oral use. Tablet is taken twice a day, for at least 28 days and a maximum of 30 days.
16183930|NCT01516970|Drug|NRTIs|The NRTIs (including tenofovir/emtricitabine [Truvada], lamivudine/zidovudine [Combivir]) will be administered as per the individual Summary of Product Characteristics (SmPCs) at the discretion of either the treating physician or Investigator.
16183931|NCT01516970|Drug|Efavirenz|type=exact number, unit=mg, number=600, form=tablet, route=oral use. Tablet is taken once a day, for at least 28 days and a maximum of 30 days.
16183932|NCT01516957|Drug|AMG 827 140|140 mg AMG 827 SC (subcutaneous)
16183933|NCT01516957|Drug|Placebo|Placebo SC (subcutaneous)
16183934|NCT01516957|Drug|AMG 827 280|280 mg AMG 827 SC (subcutaneous)
16183935|NCT01516957|Drug|AMG 827 210|210 mg AMG 827 SC (subcutaneous)
16183936|NCT01516944|Drug|Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin|Tegafur，Gimeracil and Oteracil Potassium Capsules 80 mg/m2 D1-D14 q3wk and Oxaliplatin 130 mg/m2 D1 q3wk for six cycles postoperation
16183937|NCT01516944|Drug|Tegafur, Gimeracil and Oteracil Potassium Capsules；Oxaliplatin|Tegafur，Gimeracil and Oteracil Potassium Capsules 80mg/㎡ ,D1-D14 q3wk and Oxaliplatin,130 mg/㎡ D1 q3wk for two cycles preoperation, Tegafur，Gimeracil and Oteracil Potassium Capsules ,80 mg/㎡ D1-D14 q3wk and Oxaliplatin,130 mg/㎡ D1 q3wk for six cycles postoperation
16183938|NCT01516944|Drug|Oxaliplatin; Capecitabine|Capecitabine,2000 mg/㎡ D1-D14 q3wk and Oxaliplatin,130 mg/㎡ D1 q3wk for two cycle pre-operation, Capecitabine,2000 mg/㎡ D1-D14 q3wk and Oxaliplatin,130 mg/m2 D1 q3wk for six cycles postoperation
16183939|NCT01516931|Procedure|repetitive Transcranial Magnetic Stimulation (rTMS)|1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.5 sessions per week for 4-6 weeks
16183940|NCT01516931|Behavioral|counseling|Placebo monthly by general counseling for 12 months.
16183941|NCT01516918|Drug|VX-222|tablet, 400-mg twice daily
16183942|NCT01516918|Drug|telaprevir|tablet, 1125-mg twice daily
16183943|NCT01516918|Drug|ribavirin|tablet, 1000-mg per day for subjects weighing <75 kg and 1200 mg per day for subjects weighing ≥75 kg, twice daily
16183944|NCT01516918|Biological|peginterferon-alfa-2a|subcutaneous injection, 180-mcg, once weekly
16183945|NCT01516905|Drug|NM404|injection of either 2.0mCi or 5.0mCi I-124 NM404
16183946|NCT01516892|Biological|onabotulinumtoxinA|Participants received 155 U of onabotulinumtoxinA approximately every 12 weeks for 108 weeks. OnabotulinumtoxinA was administered as 31 intramuscular injections in 7 head/neck muscle areas.
16183947|NCT01516879|Biological|Evolocumab|Administered by subcutaneous injection once a month
16183948|NCT01516879|Biological|Placebo|Administered by subcutaneous injection once a month
16183949|NCT01516879|Drug|Atorvastatin|Background lipid lowering therapy: 10 mg or 80 mg atorvastatin orally once daily.
16183950|NCT01516879|Drug|Ezetimibe|Background lipid lowering therapy: ezetimibe 10 mg orally once a day
16183951|NCT01516879|Other|Diet Only|Diet only, no lipid lowering background drug given
16183952|NCT01516866|Procedure|Sodium Fluoride (NaF) Positron Emission Tomography/Computed Tomography (PET/CT) imaging|Subjects who will be enrolled will be those who will be starting treatment (as part of standard of care or as part of another trial) with either a microtubule directed chemotherapy regimen (cohort A), or AR-directed therapy (cohort B). All subjects will have a baseline NaF PET/CT scan (baseline #1), performed within days prior to starting either chemotherapy or AR-directed therapy. A subset of subjects (up to 20 subjects per site, 60 total) will undergo a second NaF PET/CT scan (baseline #2) within 1-8 days of the initial scan to determine repeatability of NaF PET/CT scanning. Subjects in cohort A will undergo another NaF PET/CT scan at week 8 (+/- 1 week). Subjects in cohort B will undergo two additional NaF PET/CT scans at weeks 6 and 12 (+/- 1 week).
16183953|NCT01516853|Device|Non-contrast MRI|Non-contrast MRI will be performed on each subject, at both 1.5T and 3.0T. Different MRI sequences (spin-echo and gradient-echo) will be used, with varying acquisition parameters (e.g., echo times, spatial resolution).
16183954|NCT01516840|Drug|Rivaroxaban (Xarelto, BAY59-7939)|10 mg twice daily for 21 days, followed by 15 mg once daily
16183955|NCT01516840|Drug|Rivaroxaban (Xarelto, BAY59-7939)|15 mg twice daily for 21 days, followed by 15 mg once daily
16183956|NCT01516840|Drug|Unfractionated heparin|To be adjusted to maintain the activated partial thromboplastin time (aPTT) prolongation (1.5 to 2.5 times the control)
16183957|NCT01516840|Drug|Warfarin|To be adjusted on the basis of prothrombin time-international normalized ratio (PT-INR) values target range (1.5 to 2.5)
16183958|NCT01516827|Behavioral|Trauma-Focused Cognitive Behavioral Therapy (TF-CBT)|TF-CBT (see also HThttp://tfcbt.musc.eduTH) is a manualised intervention for traumatized children and adolescents 7 to 16 years old and their parent/caregiver. The primary components are summarized by the acronym PRACTICE: Parenting skills, Psychoeducation, Relaxation, Affect modulation, Cognitive processing, Trauma narrative, In vivo mastery of trauma reminders, Conjoint child-parent session, and Enhancing safety and future development. We will use the manual as provided by Cohen et al. and available in German. The treatment program will comprise 12 sessions with children and parents (partly separated, partly conjoined sessions) of 90 minutes each. The 12 sessions will be distributed over a duration of 16 weeks.
16183959|NCT01516814|Drug|Rivaroxaban (Xarelto, BAY59-7939)|15 mg twice daily for 21 days, followed by 15 mg once daily
16183960|NCT01516814|Drug|Unfractionated heparin|To be adjusted to maintain the activated partial thromboplastin time (aPTT) prolongation (1.5 to 2.5 times the control)
16183961|NCT01516814|Drug|Warfarin|To be adjusted on the basis of prothrombin time-international normalized ratio (PT-INR) values target range (1.5 to 2.5)
16183962|NCT01516801|Other|PSA flyer|A mailed low-literacy informational patient flyer about the PSA test
16183963|NCT01516788|Other|Phototesting|Single MED dose on Day 2
16183964|NCT01516775|Other|clear fluid ingestion|drinking of clear fluid in preoperative period
16183965|NCT01516762|Drug|Radium-223 dichloride (BAY88-8223)|One injection to be administered every 4 weeks up to 6 injections. The dose per injection is 50 kBq/kg body weight.
16183966|NCT01516749|Drug|anakinra|Anakinra is supplied in individual pre-filled glass syringes 100mg/0.67mL each. It will be injected subcutaneously once daily for 8 continuous weeks.
16183967|NCT01516736|Drug|LA-EP2006|Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle LA-EP2006 is injected s.c. post chemotherapy application.
16183968|NCT01516736|Drug|Neulasta®|Eligible patients are scheduled to receive six cycles of chemotherapy every three weeks. During each chemotherapy cycle Neulasta® is injected s.c. post chemotherapy application.
16183969|NCT01516723|Device|Hybrid sirolimus- and everolimus-eluting stents (ORSIRO, XIENCE PRIME)|Recanalization of totally occluded coronary arteries
16183970|NCT01516710|Procedure|Open liver resection|Patients will be operated with open liver resection for colorectal metastasis
16183971|NCT01516710|Procedure|Laparoscopic liver resection|Patients will be operated with laparoscopic liver resection
16183972|NCT01516697|Procedure|experimental|Non-invasive cardiac output monitoring using thoracic electric bioimpedance analysis via ICON® in addition of the standard monitoring during cesarean section.
16183973|NCT01516697|Procedure|Control|Data obtained from the non-invasive cardiac output monitor,ICON®, are not available for the anesthesia care providers.
16183974|NCT01516684|Drug|placebo administration|Given topically
16183975|NCT01516684|Drug|EMLA|Given topically
16183976|NCT01516684|Drug|propofol|Given IV
16183977|NCT01516684|Drug|fentanyl citrate|Given IV
16183978|NCT01516658|Device|Hydrogel coil|at least one Hydrogel coil have to use for embolization
16183979|NCT01516658|Device|Bare platinum coil|only bare platinum coil have to use for embolization
16183980|NCT01516645|Drug|KHK2898|injection
16183981|NCT01516632|Behavioral|SMS USA|Intervention participants receive text messages daily pre-and post-quit. Everyone receives messages 14 days prior to the Quit day, and through the day after Quit. Then, participants are 'pathed' to particular messages based upon their self-reported smoking status at Day 2 and Day 7 post quit, respectively. Those who are successful at quitting receive messages aimed at relapse prevention whereas those who have slipped receive messages aimed at getting the person to recommit to quitting and trying again.
16183982|NCT01516619|Drug|Romiplostim|"Romiplostim will be administered subcutaneously at a dose of 250 μg on the 1st, 3rd and 5th days after the last day of chemotherapy delivery and, then, every two days until the achievement of 75.000 plt/μL.
~In the case of unsuccessful use of romiplostim after the second chemotherapy course, dose escalation to 500 μg/day, with the same above-mentioned schedule, will be indicated after the third course and for all the further courses, with a maximum of 8."
16183983|NCT01516606|Drug|clarithromycin, oral, high dose|2 g/day clarithromycin (once a day) for 14 days followed by 7 days interval to be repeated for 4 cycles in total
16183984|NCT01516593|Drug|Induction Phase|"dd -2 to 1: Methylprednisolone
~dd 0-1, Cyclophosphamide, associated on day 0 with Vincristine
~dd 2, Rituximab
~dd 7, Methotrexate
~dd 14, Rituximab
~dd 15, Etoposide
~dd 21, Methotrexate
~dd 29, Rituximab and Doxorubicin
~dd 36, Rituximab and VCR
~At the end of this induction phase, subsequent treatment will be performed according to the objective response:
~pts in CR: consolidation phase followed by bulky site irradiation
~pts in PR: consolidation phase followed by BEAM conditioning regimen supported by ASCT and bulky irradiation
~pts with SD after induction or PD during or after induction: intensification phase followed by BEAM conditioning regimen supported by ASCT and bulky irradiation"
16183985|NCT01516593|Drug|Consolidation Phase (on day +50)|"dd 1-2: cytarabine twice a day
~dd 3 and 11: rituximab
~dd 11-13: leukapheresis for PBPC collection."
16183986|NCT01516593|Drug|Intensification phase|"One or two courses of R-IVAC or R-ICE chemoimmunotherapy regimen, every three weeks as debulking.
~CTX (dd 1) associated with rituximab on dd 3 and 10, followed by PBPC collection (dd 11-13);
~AraC every 12 hours for four days (dd -5 to -2) supported by reinfusion of CD34+ cells (dd 0), rituximab infusion (dd -1 and +11) and second in-vivo purged PBPC collection (if needed)."
16183987|NCT01516593|Drug|BEAM conditioning|BCNU on dd 1; VP-16 every 12 hours on dd 2-5 and araC every 12 hours on dd 2-5; melphalan on dd 6, followed by the reinfusion of CD34+ cells
16183988|NCT01516593|Radiation|Consolidation radiotherapy|At the end of the whole program, patients will be evaluated for involved-field irradiation with 6-10 MeV photons and a dose of 36 Gy (2 Gy/d, five fractions a week). Three subgroups of patients will be considered for radiotherapy
16183989|NCT01516580|Drug|Vincristine, cyclophosphamide, methotrexate, doxorubicin, cytarabine, ara-C|"Prephase (COP) for all groups followed by:
~in group B: 4 courses: 2 COPADM + 2 CYM, with MTX 3g/m² in group C: 6 courses: 2 COPADM + 2 CYVE + 2 maintenance courses, with MTX 8g/m², in 4h in C1, in 24h in C3 (except the 1st course) and CNS positive patients receive additional IT before each CYVE courses and HDMTX between CYVE courses."
16184032|NCT01516307|Biological|OPT-822/OPT-821(30 μg/100 μg)|Subcutaneously on week 1, 2, 3, 5, 9, 13, 17, 25, and 37. OPT-822 and OPT-821 are combined at time of injection.
16183990|NCT01516580|Drug|Rituximab, Vincristine, cyclophosphamide, methotrexate, doxorubicin, cytarabine, ara-C|LMB chemo as in the comparator arm Rituximab 375 mg/m² i.v.: 6 injections: two doses at 48h interval are given at D-2 and D1 of the 2 first courses (COPADM) and one dose at the beginning of the 2 following courses (CYM or CYVE).
16183991|NCT01516567|Drug|Etoposide, Doxorubicin, Vincristine, Cyclophosphamide, Rituximab|6 courses of Dose Adjusted-EPOCH-Rituximab Rituximab 375 mg/m² i.v.: one injection at each of the 6 courses of EPOCH.
16183992|NCT01516554|Drug|Testosterone undecanoate|40 mg twice daily
16183993|NCT01516554|Drug|placebo|twice daily
16183994|NCT01516541|Other|Background care|Guidelines-based medical care
16183995|NCT01516541|Drug|Placebo|Matching dalcetrapib placebo orally daily
16183996|NCT01516541|Drug|dalcetrapib|600 mg orally daily
16183997|NCT01516528|Procedure|Spirometry|Assessment of lung function by spirometry
16183998|NCT01516515|Drug|Vehicle gel|placebo
16183999|NCT01516515|Drug|SR-T100 with 2.3% of SM|2.3% of SM in Solanum undatum plant extract
16184000|NCT01516502|Other|low-level laser therapy|An infrared (the low-level laser, class IIIb) gallium aluminum arsenide (Ga-Al-As) diode laser device (MediUm-TECH Medizingeräte GmbH, Germany) with a wavelength of 810nm and a maximum power output of 150mW in the continuous wave mode
16184001|NCT01516489|Behavioral|Stage 1|Patients who are prescribed an FOBT kit in one of the PVAMC Primary Care clinics (i.e., Module B or C) will be randomly assigned by day to one of 4 study arms. All FOBT kits will include a card with a description of the arm that the patient has been randomized to.
16184002|NCT01516489|Behavioral|Stage 2|Patients who are prescribed an FOBT kit in one of the PVAMC Primary Care clinics (i.e., Module B or C) will be randomly assigned by day to one of 4 study arms. All FOBT kits will include a card with a description of the arm that the patient has been randomized to. The exact dollar amounts for the Voucher-Based Incentive, Lottery-Based Incentive, and Raffle-Based Incentive arms will be based on the results of Stage 1.
16184003|NCT01516476|Drug|Placebo|Placebo for 12 weeks
16184004|NCT01516476|Drug|RO6807952|multiple doses for 12 weeks
16184005|NCT01516476|Drug|RO6807952|multiple doses for 12 weeks
16184006|NCT01516476|Drug|liraglutide|liraglutide for 12 weeks
16184007|NCT01516463|Drug|Collagenase Santyl|Applied topically (2 mm thickness once daily)
16184008|NCT01516463|Biological|Bacitracin|Applied topically (2 mm thickness) once daily
16184009|NCT01516450|Drug|GSK1550188 IV|Single IV dose of belimumab 200 mg
16184010|NCT01516450|Drug|GSK1550188 SC|Single SC dose of belimumab 200mg
16184011|NCT01516437|Procedure|Blood collection|Blood collection at Day 0 (all subjects) and at Month 6 (COPD subjects) for the analysis of serology, cell-mediated immune response.
16184012|NCT01516437|Procedure|Swab collection|Nasopharyngeal and oropharyngeal swabs collection at Day 0 (All subjects) and at exacerbation visits (COPD subjects).
16184013|NCT01516437|Procedure|Sputum collection|Sputum collection at Day 0 and at exacerbation visits (COPD subjects)
16184014|NCT01516424|Drug|Blonanserin|Blonanserin tablets: 8 - 24mg/day; twice daily after breakfast and dinner; in the meantime, the placebo and positive drug were taken in whole tablets. When the morning and evening doses could not be administered equally, the evening dose should be greater than the morning dose. The interval between 2 dose escalations should not be shorter than 3 days.
16184015|NCT01516424|Drug|Risperidone|Risperidone tablets: 2 - 6mg/day; twice daily after breakfast and dinner; in the meantime, the placebo and positive drug were taken in whole tablets. When the morning and evening doses could not be administered equally, the evening dose should be greater than the morning dose. The interval between 2 dose escalations should not be shorter than 3 days.
16184016|NCT01516411|Behavioral|Mobile Intervention for Lifestyle Eating/Exercise @ Stanford|Participants are randomized to one of 4 groups, each of which uses a different Smartphone app to promote health behavior change
16184017|NCT01516372|Drug|GEn 1200mg|1200 mg of Gen administered as a single dose
16184018|NCT01516372|Drug|Gen 6000 mg|6000 mg of Gen administered as a single dose
16184019|NCT01516372|Drug|GEn Placebo|Placebo to match GEn Tablets
16184020|NCT01516372|Drug|Moxifloxacin Placebo|Placebo to match Moxifloxacin
16184021|NCT01516372|Drug|Moxifloxacin|400 mg Moxifloxacin administered as a single dose
16184022|NCT01516346|Drug|Isosorbide Dinitrate|Enrolled subjects will be randomized in a blinded fashion to 1 isosorbide dinitrate capsule TID + 1 placebo capsule TID. In addition, all subjects will receive a single in-lab dose of 0.4 mg of sublingual nitroglycerine (open label) before randomization to the blinded study drugs. Subjects receiving isosorbide dinitrate will be given 20mg PO q8am, 2pm, and 8pm and will be titrated up to 40mg PO q8am, 2pm, and 8pm.
16184023|NCT01516346|Drug|Isosorbide Dinitrate + Hydralazine|Enrolled subjects will be randomized in a blinded fashion to 1 isosorbide dinitrate capsule TID + 1 hydralazine capsule TID. In addition, all subjects will receive a single in-lab dose of 0.4 mg of sublingual nitroglycerine (open label) before randomization to the blinded study drugs. Subjects receiving isosorbide dinitrate will be given 20mg PO q8am, 2pm, and 8pm and will be titrated up to 40mg PO q8am, 2pm, and 8pm. Subjects receiving hydralazine will be given 37.5mg PO q8am, 2pm, and 8pm and will be titrated up to 75mg PO q8am, 2pm, and 8pm.
16184024|NCT01516346|Drug|Placebo|Enrolled subjects will be randomized in a blinded fashion to 2 placebo capsules TID. In addition, all subjects will receive a single in-lab dose of 0.4 mg of sublingual nitroglycerine (open label) before randomization to the blinded study drugs.
16184025|NCT01516333|Other|High GL 107|Three meals a day
16184026|NCT01516333|Other|Medium GL 76|Three meals a day
16184027|NCT01516333|Other|Medium GL 68|Three meals a day
16184028|NCT01516333|Other|Low GL 48|Three meals a day
16184029|NCT01516320|Procedure|Roux-en-Y Gastric Bypass|A surgical technique in which the stomach is stapled into a smaller pouch and then attached directly to the small intestine, bypassing the rest of the original stomach. The goal of the surgery is weight loss.
16184030|NCT01516320|Procedure|Laparoscopic adjustable gastric banding|A surgical technique in which an inflatable silicone device placed around the top portion of the stomach, creating a smaller gastric pouch. The goal of the surgery is weight loss.
16184031|NCT01516320|Procedure|Vertical Sleeve Gastrectomy|A surgical technique in which a large portion of the stomach is removed, leaving only a smaller gastric pouch. The goal of the surgery is weight loss.
16184033|NCT01516307|Biological|Phosphate Buffer Saline (PBS)|Subcutaneously on week 1, 2, 3, 5, 9, 13, 17, 25, and 37.
16184034|NCT01516307|Drug|Cyclophosphamide|Subcutaneously on week 1, 2, 3, 5, 9, 13, 17, 25, and 37.
16184035|NCT01516294|Radiation|Iray|The Oraya IRay stereotactic radiotherapy device will be used to deliver a 16 Gy dose of radiation to the macula. The radiotherapy will be delivered in a single session utilizing three sequential beams, each depositing 5.3 Gy at the macula through calculated scleral entry points, crossing the pars plana region of the eye, and overlapping at the same region of the macula.
16184036|NCT01516268|Drug|Sufentanyl|"As intervention 1cc sufentanyl is added to bupivacain in case group for TAP block.
~As comparator 1cc normal saline is added to bupivacain in control group for Tap block."
16184037|NCT01516255|Drug|liraglutide|0.6 mg daily for 7 days followed by 1.2 mg daily for 7 days followed by 1.8 mg daily for 7 days. Injected subcutaneously. Subjects are randomly allocated to two treatment sequences
16184038|NCT01516255|Drug|placebo|Injected subcutaneously. Subjects are randomly allocated to two treatment sequences
16184039|NCT01516255|Drug|moxifloxacin|Following the double-blinded period and a wash-out period of 7 days, subjects are re-randomised to an open-label, parallel period where a single dose of 400 mg moxifloxacin (tablets) is administered as positive control
16184040|NCT01516255|Drug|placebo|Following the double-blinded period and a wash-out period of 7 days, subjects are re-randomised to an open-label, parallel period where single dose of oral placebo is administered
16184041|NCT01516255|Procedure|electrocardiogram (ECG)|24 hours serial ECG is collected before initial dose of 0.6 mg liraglutide, on the last dosing day of 1.2 mg liraglutide and on the last dosing day of 1.8 mg liraglutide
16184042|NCT01516255|Procedure|electrocardiogram (ECG)|Six hours after moxifloxacin or placebo single dose, 1 hour serial ECG is collected
16184043|NCT01516242|Other|No treatment given|Collection of data about patients with type 1 diabetes or type 2 diabetes treated with insulin changing their insulin administration from syringe to a insulin delivery system based on completion of questionaire
16184044|NCT01516229|Drug|somatropin|Prescription of somatropin at the discretion of the physician
16184045|NCT01516216|Drug|FOLFOX + bevacizumab|Given intravenously on Day 1 of every cycle
16184046|NCT01516216|Dietary Supplement|Vitamin D|Standard Dose (400 IU once daily)
16184047|NCT01516216|Dietary Supplement|Vitamin D|Higher Dose (8000 IU once daily for 2 weeks, followed by 4000 IU once daily)
16184048|NCT01516203|Drug|AZD5847|Eligible subjects will be randomly assigned to receive monotherapy with one of four doses of oral AZD5847 for 14 days: 500 mg orally once daily, 500 mg orally twice daily, 1200 mg orally once daily, or 800 mg orally twice daily.
16184049|NCT01516203|Drug|Ethambutol, isoniazid, pyrazinamide, rifampin|Eligible subjects will be randomly assigned to receive treatment with standard 4 drug anti-tuberculosis regimen: Rifafour e-275 mg tablets (75 mg isoniazid/150 mg Rifampin/275 mg Ethambutol/400 mg Pyrazinamide) orally, dosed by body weight for 14 days.
16184050|NCT01516190|Behavioral|Exercise|Supervised exercise sessions and independent exercise
16184051|NCT01516190|Behavioral|Surgical preparation program|Book, tapes, CD
16184052|NCT01516164|Device|Laryngoscopy|After establishing full monitoring, inducing general anaesthesia and ensuring paralysis laryngoscopy is performed and the patient's trachea intubated.
16184053|NCT01516151|Dietary Supplement|CaPre™|1 capsule of 0.5g total CaPre™ for 4 weeks followed by one 1.0g capsule per day for an additional 4 weeks
16184054|NCT01516151|Dietary Supplement|CaPre™|1 capsule of 1.0g total CaPre™ for 4 weeks followed by two 1.0g capsules per day for an additional 4 weeks
16184055|NCT01516151|Dietary Supplement|CaPre™|2 capsules of 1.0g total CaPre™ for 4 weeks followed by 4 capsules of 1.0g total per day for an additional 4 weeks.
16184056|NCT01516151|Drug|Lipid Lowering Medication|Patient will be treated as per the Standard of care.
16184057|NCT01516151|Dietary Supplement|CaPre™|4 capsules of 1 g total per day for 8 weeks.
16184058|NCT01516138|Drug|GIK|Intravenous solution was started at about 10 minutes before general anesthesia, running at a rate of 1 mL/kg/h for 12.5 hours.
16184059|NCT01516138|Drug|Control|Intravenous solution was started at about 10 minutes before general anesthesia, running at a rate of 1 mL/kg/h for 12.5 hours.
16184060|NCT01516099|Other|General Practitioners|The general practitioner can refer his patients to a physical activity counselor for an individual coaching (intake session with development of program and pretesting, follow up by e-mail or phone (max 4x), personal contact moments (max 3x) and exit session with evaluation and posttesting).
16184061|NCT01516099|Other|Social-cultural organizations|In the social-cultural organization, members can sign in for group sessions led by the physical activity counselor (intake session with development of program and pretesting, follow up by email or letters (max 4x), personal contact moments (max 4x) and exit session with evaluation and posttesting).
16184062|NCT01516086|Drug|Fluticasone Propionate (FP)|FP Inhalation BID
16184063|NCT01516073|Drug|Fluticasone Propionate|FP BID for 12 weeks
16184064|NCT01516060|Drug|Efavirenz|400mg qd; 2 x 200mg
16184065|NCT01516060|Drug|Efavirenz|600mg qd; 3 x 200mg qd
16184066|NCT01516047|Drug|Cohort 1|125 mg to 2000 mg abiraterone acetate suspension on Day 1
16184067|NCT01516047|Drug|Cohort 2|2000 mg abiraterone acetate suspension on Day 1
16184068|NCT01516034|Device|Cupola Tattoo Removal device|Up to 6 treatments with the device every 2-3 weeks to the tattoo area.
16184069|NCT01516021|Dietary Supplement|intake of high or low fat yoghurt|intake of 500 ml of a high fat yoghurt on one day and intake of 500 ml of a low fat yoghurt on the other day
16184070|NCT01516008|Drug|Tapentadol IR 50 mg|Type= exact number, unit= mg, number= 50, form= tablet, route= oral use. Tapentadol IR will be administered as a single oral dose once every 4 to 6 hours (patients may take their next dose as early as 4 hours, but no later than 6 hours, after the previous dose), for a period of 72 hours.
16184071|NCT01516008|Drug|Tapentadol IR 75 mg|Type= exact number, unit= mg, number= 75, form= tablet, route= oral use. Tapentadol IR will be administered as a single oral dose once every 4 to 6 hours (patients may take their next dose as early as 4 hours, but no later than 6 hours, after the previous dose), for a period of 72 hours.
16184072|NCT01516008|Drug|Placebo|Form= tablet, route= oral use. Placebo tablets will be administered as a single oral dose every 4 to 6 hours, for a period of 72 hours.
16184222|NCT01514929|Drug|ACHN-490 Injection|15mg/kg IV 30 minute infusion given once
16184073|NCT01515995|Drug|Nebulized magnesium sulfate|"15 mg albuterol in 22 ml of magnesium sulfate solution (880 mg) via nebulizer over one hour
~Versus
~15 mg albuterol in 22 ml of normal saline via nebulizer over one hour"
16184074|NCT01515982|Behavioral|Aerobic Exercise|The training exercise intensity is established at 60% of VO2máx. This intensity was determined using exercise prescription guidelines established by the American College of Sports Medicine (ACSM). Each aerobic session began with a 10-minute warm-up period (40%VO2máx), followed by 20 minutes of continuous treadmill walking at an intensity established by 60% of VO2máx. The exercise session will be concluded with a 5 minutes of cool down. Heart hate (Polar® Sport Tester, Finland) and perceived exertion (Borg Scale) will be monitored and recorded at each five minutes during each exercise session by physical education instructors.
16184075|NCT01515982|Behavioral|Control Group|All participants were asked not to commence any new exercise regimen.
16184076|NCT01515969|Drug|Erlotinib hydrochloride|Given PO
16184077|NCT01515969|Drug|Dovitinib lactate|Given PO
16184078|NCT01515956|Drug|BMN 110|Patients will receive intravenous (IV) infusions of study drug at a dose of 2.0 mg/kg/wk over a period of approximately 4 hours every week for up to 208 weeks.
16184079|NCT01515943|Other|Active home-based computer vergence/accommodative therapy|At enrollment, subjects will be prescribed 15 minutes/day of active home-based computer therapy for 5 days/week during the 12 week treatment phase. Active home-based computer therapy will be provided the Home Therapy System (HTS) computer software and will include both fusional vergence and accommodative therapy. Subjects will perform the computer therapy while wearing red/blue glasses and accommodative therapy will be performed using the HTS accommodative flippers. Please refer to the procedures manual for further details.
16184080|NCT01515943|Procedure|Near target push-ups|At enrollment, subjects will be prescribed 15 minutes/day (3 sessions of 5 minutes each) of near target push-ups (NTP) for 5 days/week during the 12-week treatment phase. An alphabet pencil will be used as the target and an index card placed in the background will provide physiological diplopia control. With the pencil positioned at arm's length directly between the subject's eyes, the subject will slowly bring the pencil toward his/her nose while focusing on the small letter on the pencil. When the subject is no longer able to maintain a single image of the pencil, he/she will slowly move the target away from the nose until the pencil becomes single again. This procedure will be repeated several times. Please refer to the procedures manual for further details.
16184081|NCT01515943|Other|Placebo home-based computer vergence/accommodative therapy|At enrollment, subjects will be prescribed either 5 minutes/day (NTP group) or 15 minutes/day (Placebo group) of placebo home-based computer therapy for 5 days/week during the 12 week treatment phase. Placebo computer-based therapy will be provided by the Home Therapy System (HTS) computer software. The vergence procedures are similar to the active version, however, the tasks will be modified to ensure no demand on the vergence system and no accommodative therapy is included in the placebo version. Please refer to the procedures manual for further details.
16184082|NCT01515943|Procedure|Placebo yoked prism flippers|"Subjects will be prescribed 5 minutes/day of placebo yoked prism flipper therapy for 5 days/week during the 12 week treatment phase. This procedure utilizes a 4 pd base right/4 pd base left prism flipper and Accommodative Hopping Cards. Subjects view the text on the card through the prisms at 40 cm, perform the appropriate task and then flip the prism flipper to the other side after each word before proceeding to the next line. Please refer to the procedures manual for further details. The task remains constant, but the nature of the procedure changes with time:
~Weeks 1-4: View the target through prism flippers
~Weeks 5-8: Wear red-blue filter glasses while viewing the text through prism flippers
~Weeks 9-12: Wear polaroid glasses while viewing the text through prism flippers"
16184083|NCT01515930|Behavioral|Parent Computer-Delivered Motivational Intervention|Motivational Interviewing (MI) is a client-centered, directive method for enhancing intrinsic motivation to change by exploring & resolving ambivalence, with a strong evidence for improving adolescent & adult health behaviors. Three motivational sessions will be provided by an animated character who delivers the intervention with high fidelity to MI principles. Small amounts of psychoeducation about potential improvements illness management that can result from parental monitoring of diabetes care will be integrated with more purely motivational elements. Mailings will be sent to participants to remind them of the reasons they gave as motivation & goals they set regarding monitoring diabetes care.
16184084|NCT01515930|Behavioral|Parent & Child Computer-Delivered Motivational Intervention|Motivational Interviewing (MI) is a client-centered, directive method for enhancing intrinsic motivation to change by exploring & resolving ambivalence, with a strong evidence for improving adolescent & adult health behaviors. Three motivational sessions will be provided by an animated character who delivers the intervention with high fidelity to MI principles. Small amounts of psychoeducation about potential improvements illness management that can result from monitoring/completing diabetes care will be integrated with more purely motivational elements. Mailings will be sent to participants to remind them of the reasons they gave as motivation & goals they set regarding diabetes care.
16184085|NCT01515930|Behavioral|Computer-Delivered Information|Computer-Delivered Information about issues related to living with diabetes that do not directly impact completing diabetes care.
16184086|NCT01515917|Drug|Citicoline|Participants randomly assigned to the experimental group, who, in addition to the research staff will be blind to such assignment, will be instructed to orally administer 1000 mg daily citicoline. These participants will receive a 14-day supply of citicoline at visit 1 and again at visit 2, making for a 28-day administration period.
16184087|NCT01515917|Drug|Omega-3|Participants randomly assigned to the experimental group, who, in addition to the research staff will be blind to such assignment, will be instructed to orally administer 2000 mg daily omega-3. These participants will receive a 14-day supply of omega-3 at visit 1 and again at visit 2, making for a 28-day administration period.
16184088|NCT01515917|Other|Rice bran oil|Rice bran oil will be one of two placebos administered to participants randomly assigned to the placebo arm. Rice bran oil will serve as the placebo for omega-3 fatty acids and will be orally administered daily in 500 mg doses.
16184089|NCT01515917|Other|Microcrystalline Cellulose|Microcrystalline Cellulose will be one of two placebos administered to participants randomly assigned to the placebo arm. Microcrystalline Cellulose will serve as the placebo for Citicoline and will be orally administered daily in 470 mg doses.
16184128|NCT01515592|Drug|liraglutide|One daily subcutaneous dose for 5 weeks. 5 mcg/kg the first week, then 10 mcg the second week followed by 15 mcg the third week, and finally 20 mcg for 2 weeks
16184090|NCT01515904|Behavioral|STOMP Clinic|"A new interdisciplinary clinic (STOMP) was created to provide care for children and adolescents with severe 'complex' obesity. As part of the program, a subset of adolescents undergo bariatric surgery. The core elements include an interdisciplinary team, frequent visits, individualized care plans for medically-complex adolescents) and building on other aspects, such as increased psychosocial intervention; involvement of a key worker (nurse practitioner) to support families; provision of continuity of care with other health providers in all settings, community services and schools; a more diverse patient population; and group support sessions."
16184091|NCT01515891|Drug|BIA 9-1067|90 µCi (3.33 MBq) [14C]-labeled of 100 mg BIA 9-1067 (single-dose).
16184092|NCT01515878|Device|Hemocontrol|Blood Volume Tracking system using biofeedback
16184093|NCT01515865|Drug|Midodrine HCl|dose at subject's current dose level
16184094|NCT01515865|Drug|Placebo|single dose of matching placebo
16184095|NCT01515852|Procedure|general anesthesia in stereotactic biopsy|stereotactic biopsy
16184096|NCT01515852|Procedure|local anesthesia in stereotactic biopsy|stereotactic biopsy
16184097|NCT01515839|Dietary Supplement|Multivitamin Supplement intervention|"We recommend the following protocol:
~2 tablets of a high quality multivitamin BID
~2 capsules of omega 3 fish oil BID for a total of 3 grams daily
~3 capsules of a brain and memory formula BID which contains Acetyl-L-Carnitine (HCL) 1000 mg, Ginkgo Biloba Extract 120 mg, Alpha-Lipoic Acid (ALA) 300 mg, Huperzine A (Huperzia serrata)150 mcg, N-Acetyl-L-Cysteine (NAC) 600mg, Phosphatidyl Serine (soy) 100 mg, Vinpocetine 15mg
~Weight loss"
16184098|NCT01515826|Drug|Moxifloxacin 0.5%/Dexamethasone Phosphate 0.075% Ophthalmic Gel (VIGADEXA Gel)|One ribbon (approximately 1-1.5 cm) administered topically in the conjunctival sac of the study eye three times daily (TID), starting the day before surgery (Day -1) and continuing on the day of surgery and for 15 days following surgery.
16184099|NCT01515826|Drug|Moxifloxacin 0.5%/Dexamethasone Phosphate 0.1% Ophthalmic Solution (VIGADEXA Solution)|One drop administered topically in the conjunctival sac of the study eye four times daily (QID), starting the day before surgery (Day -1) and continuing on the day of surgery and for 15 days following surgery.
16184100|NCT01515813|Drug|Pravastatin sodium|One 40 mg tablet of Pravastatin sodium taken orally once daily.
16184101|NCT01515813|Drug|Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate|Participant will be administered one tablet of Efavirenz/Emtricitabine/Tenofovir Disoproxil Fumarate (EFV/FTC/TDF)600 mg/200 mg/300 mg taken orally once daily
16184102|NCT01515813|Drug|Pravastatin sodium|Two 40mg tablets (80 mg total) of Pravastatin sodium taken orally once daily.
16184103|NCT01515800|Behavioral|Text message reminder|Receive text message
16184108|NCT01515774|Drug|Mirapex ER|Change Requip or Mirapex to Mirapex ER
16184109|NCT01515761|Procedure|Postero-lateral|A device implant procedure will be performed under the standard of care technique with the right ventricular lead at the right ventricular apex and the left ventricular lead targeting or postero-lateral area of the LV based on pre-procedure randomization.
16184110|NCT01515761|Procedure|Antero-Lateral|A device implant procedure will be performed under the standard of care technique with the right ventricular lead at the right ventricular apex and the left ventricular lead targeting or antero-lateral area of the LV based on pre-procedure randomization.
16184114|NCT01515722|Behavioral|Health education intervention (HEI)|"<Part 1> Understanding OAB
~<Part 2> Behavioral/lifestyle modification
~<Part 3> Bladder training
~<Part 4> Understanding antimuscarinics"
16184115|NCT01515696|Drug|Gastrografin|Patients will receive 3ml Gastrografin + 6ml sterile water/kg as a single dose via a nasogastric tube during the first 24 hours of life.
16184116|NCT01515696|Drug|Sterile water|Patients will receive 9ml/kg sterile water as a single dose via a nasogastric tube during the first 24 hours of life.
16184117|NCT01515683|Behavioral|Only support from an anaesthetic nurse on the surgery ward|Additional staff are only present if required by law.
16184118|NCT01515683|Behavioral|Support: a theatre nurse + an anaesthetic nurse|Theatre nurse stay with the patient, follow her to the operating table and stays with her until she is anaesthetized
16184119|NCT01515683|Behavioral|Support: a nurse from the ward + an anaesthetic nurse|A nurse from the ward follows the patient to the operating table and stays with her until she is anaesthetized.
16184120|NCT01515683|Behavioral|Optional relative supports|Optional relative follows the patient to the operating table and stays with her until she is anaesthetized
16184121|NCT01515657|Drug|PL2200 Aspirin Capsules|325 mg aspirin; once per day for 3 days
16184122|NCT01515657|Drug|Immediate-Release Aspirin Tablets|325 mg aspirin; once per day for 3 days
16184123|NCT01515657|Drug|Enteric-coated aspirin caplets|325 mg aspirin; once per day for 3 days
16184124|NCT01515644|Other|Powder based infant formula|Powder based infant formula with Inulin I
16184125|NCT01515644|Other|Powder based infant formula|Powder based infant formula with Inulin II
16184126|NCT01515644|Other|Powder based infant formula|Powder based infant formula without Inulin
16184127|NCT01515592|Drug|liraglutide|One daily subcutaneous dose for 5 weeks. Dose is weekly incremented with 5 mcg/kg
16184129|NCT01515592|Drug|liraglutide|One daily subcutaneous dose for 5 weeks. 5 mcg/kg the first week, then 10 mcg the second week followed by 15 mcg for 3 weeks
16184130|NCT01515592|Drug|placebo|Liraglutide placebo administered to subjects randomised at each dose level in the ratio of 3:1
16184131|NCT01515579|Drug|liraglutide|One single dose of 6.25 mg/mL administered subcutaneously
16184132|NCT01515579|Drug|liraglutide|One single dose of 6.0 mg/mL administered subcutaneously
16184133|NCT01515566|Drug|Fentanyl|Fentanyl SQ dose equivalent to 15-25% of the morphine equivalent daily dose (MEDD) 15 minutes before 6 minute walk test.
16184134|NCT01515566|Other|Placebo|Normal saline 0.9% preservative free SQ 15 minutes before walk test.
16184135|NCT01515566|Other|Walking Tests|6 minute walk test at baseline and 15 minutes after Fentanyl or Placebo.
16184136|NCT01515566|Behavioral|Questionnaires|Questionnaires completed at baseline (two) and after study visit (one) taking about 5 ot 10 minutes to complete.
16184137|NCT01515553|Drug|liraglutide|Two single doses of 0.72 mg liraglutide administered subcutaneously on two different dosing occasions separated by a wash-out period
16184138|NCT01515540|Drug|lidocaine|5% lidoderm patch
16184139|NCT01515540|Drug|placebo|placebo
16184140|NCT01515527|Drug|Cladribine|"Induction cycle: 5 mg/m2 by vein on days 1 - 5 for up to 2, 28 day cycles.
~Consolidation cycle: 5 mg/m2 by vein on days 1 - 3 of cycles 2, 5, 6, 9, 10, 13, 14, 17, and 18."
16184141|NCT01515527|Drug|Cytarabine|"Induction cycle: 20 mg subcutaneously twice daily on days 1-10 for up to 2, 28 day cycles.
~Consolidation cycle: 20 mg subcutaneously twice daily on days 1 - 10 of cycles 2, 5, 6, 9, 10, 13, 14, 17, and 18."
16184142|NCT01515527|Drug|Decitabine|Consolidation cycle: 20 mg/m2 by vein over 1 to 2 hours on days 1-5 of cycles 3, 4, 7, 8, 11, 12, 15, and 16.
16184143|NCT01515501|Procedure|Endoscopic mucosal resection (EMR)|EMR uses an endoscope to take a tissue sample from the rectum. It is the same type of instrument used in a routine colonoscopy. It is hoped that this procedure will help diagnose Hirschsprung's Disease more often than by recal suction biopsy alone, which can often be unclear and result in more invasive surgery for diagnosis.
16184144|NCT01515488|Other|Nurse-initiated triage|Nurse-assisted triage for obtaining medical history and presenting problem(s)
16184145|NCT01515488|Other|Self-triage kiosk|Audio-assisted self-triage kiosk for obtaining medical history and presenting problem(s)
16184146|NCT01515475|Procedure|Glasses|Glasses will be prescribed at enrollment with the sphere cut symmetrically by 1.00D and full cylinder correction.
16184147|NCT01515462|Genetic|OTL-103|OTL-103 is an autologous CD34+ cells collected from bone marrow and/or peripheral blood and transduced with a lentiviral vector encoding Wiskott-Aldrich syndrome (WAS) protein
16184148|NCT01515436|Other|Mozart alternating with Beethoven|Study participants will listen to Mozart's Sonata for Two Pianos in D Major, K. 448 alternating with Beethoven's Fur Elise.
16184149|NCT01515436|Other|Beethoven alternating with Mozart|Study participants will listen to Beethoven's Fur Elise alternating with Mozart's Sonata for Two Pianos in D Major, K. 448.
16184150|NCT01515423|Drug|PP3M 175 mg eq.|Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use. One injection every third month for 48 weeks.
16184151|NCT01515423|Drug|PP3M 263 mg eq.|Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use. One injection every third month for 48 weeks.
16184152|NCT01515423|Drug|PP3M 350 mg eq.|Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use. One injection every third month for 48 weeks.
16184153|NCT01515423|Drug|PP3M 525 mg eq.|Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use. One injection every third month for 48 weeks.
16184154|NCT01515423|Drug|Placebo (20% Intralipid)|Form= injection, route= intramuscular use. One injection monthly when not receiving active medication for 48 weeks.
16184155|NCT01515423|Drug|PP1M 50 mg eq.|Type= exact number, unit= mg eq., number= 50, form= injection, route= intramuscular use. One injection every month for 48 weeks.
16184156|NCT01515423|Drug|PP1M 75 mg eq.|Type= exact number, unit= mg eq., number= 75, form= injection, route= intramuscular use. One injection every month for 48 weeks.
16184157|NCT01515423|Drug|PP1M 100 mg eq.|Type= exact number, unit= mg eq., number= 100, form= injection, route= intramuscular use. One injection every month for 48 weeks.
16184158|NCT01515423|Drug|PP1M 150 mg eq.|Type= exact number, unit= mg eq., number= 150, form= injection, route= intramuscular use. One injection every month for 48 weeks.
16184159|NCT01515410|Drug|DM-1992|72.5mg carbidopa/230mg levodopa
16184160|NCT01515410|Drug|Sinemet IR|Immediate-release tablet containing 25mg carbidopa and 100mg levodopa
16184161|NCT01515397|Drug|Gelofusine balanced|Gelofusine balanced combined with Sterofundin ISO
16184162|NCT01515397|Drug|Gelofusine 4%|Gelofusine 4% combined with NaCl 0.9%
16184163|NCT01515384|Drug|18F-AV-133|IV injection, 7.6 mCi (281.2 MBq)
16184164|NCT01515371|Drug|IncobotulinumtoxinA|"Subject to receive one injection of either 2.5U, 5U or 7.4U of IncobotulinumtoxinA.
~For three dose stages: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), reconstitution volume 8 ml, 4 ml and 2.7 ml per 50U vial, respectively, resulting in a concentration of 6.25 U/ml, 12.5 U/ml and 18.5 U/ml. Injection volume is 0.4 ml for all three dose stages. Mode of administration: unilateral soft palate injection."
16184165|NCT01515371|Drug|Placebo Comparator|For three dose stages: solution prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), reconstitution volume 8 ml, 4 ml and 2.7 ml per vial, respectively. Injection volume is 0.4 ml for all three dose stages. Mode of administration: unilateral soft palate injection.
16184166|NCT01515358|Drug|Placebo|Administered orally
16184167|NCT01515358|Drug|LY3000328|Administered orally
16184168|NCT01515345|Drug|prasugrel or ticagrelor|prasugrel 10mg od for 12 month ticagrelor 90mg td for 12 month
16184169|NCT01515345|Drug|Clopidogrel|clopidogrel 75mg od for 12 month
16184170|NCT01515319|Drug|Y242|Single ascending dose: subcutaneous injection of 2, 7.5, 15, 30, 60 and 90 mg Y242 (Part A); Multiple ascending dose: Y242 single subcutaneous dose, administered once a week for 5 weeks (Part B)
16184171|NCT01515319|Drug|0.9% saline|Identical volume to that of Y242
16184172|NCT01515306|Biological|ramucirumab (IMC-1121B)|ramucirumab (IMC-1121B) 8 milligrams/kilogram (mg/kg) intravenous infusion, administered on Day 1and Day 15 of each 4-week cycle, unless otherwise specified.
16184221|NCT01514929|Drug|ACHN-490 Injection|20mg/kg IV 30 minute infusion given once
16184173|NCT01515306|Drug|paclitaxel|paclitaxel 80 milligrams/square meter (mg/m²) intravenous infusion, administered on Days 1, 8 and 15 of each 4-week cycle, unless otherwise specified.
16184174|NCT01515293|Procedure|Single Incision Laparoscopic Appendectomy|
16184175|NCT01515293|Procedure|Conventional appendectomy|
16184176|NCT01515254|Behavioral|lifestyle counseling, parental feeding|Intervention group subjects will undergo a Feeding Dynamic Intervention (FDI). The intervention will be delivered in a closed group setting and will consist of 6 intervention sessions lasting 90 minutes each. Visits to physicians, WIC offices, nutrition program etc will be tracked. The subjects will undergo the energy regulation tests at baseline and 3 months. They will complete surveys and have their weight taken.
16184177|NCT01515241|Drug|CER-001|Weekly injection
16184178|NCT01515228|Device|Xience Prime|everolimus-eluting stent implantation
16184179|NCT01515228|Device|Cilotax stent|paclitaxel with cilostazol dual drug eluting stent implantation
16184180|NCT01515215|Device|Repetitive Transcranial Magnetic Stimulation|Magnetic pulses to specific brain regions. (MagPro X100)
16184181|NCT01515202|Drug|BMS-823778|Capsules, Oral, 2 mg, Once daily, 14 days
16184182|NCT01515202|Drug|BMS-823778|Capsules, Oral, 12 mg, Once daily, 14 days
16184183|NCT01515202|Drug|BMS-823778|Capsules, Oral, 25 mg, Once daily, 14 days
16184184|NCT01515202|Drug|BMS-823778|Capsules, Oral, 15 mg, Once daily, 14 days
16184185|NCT01515202|Drug|Placebo matching with BMS-823778|Capsules, Oral, 0 mg, Once daily, 14 days
16184186|NCT01515189|Biological|Ipilimumab|
16184187|NCT01515176|Drug|Dinaciclib|Given IV
16184188|NCT01515176|Other|Laboratory Biomarker Analysis|Correlative studies
16184189|NCT01515176|Biological|Ofatumumab|Given IV
16184190|NCT01515176|Other|Pharmacological Study|Correlative studies
16184191|NCT01515163|Behavioral|Exercise training|Aerobic exercise training, two times a week
16184192|NCT01515137|Drug|Erlotinib|Erlotinib (150 mg PO QD) plus sulindac (150 mg PO BID) (Arm A), Erlotinib (150 mg PO QD) (Arm B) or placebo (for Erlotinib) QD (Arm C).
16184193|NCT01515137|Drug|Erlotinib plus sulindac|Erlotinib (150 mg PO QD) plus sulindac (150 mg PO BID) (Arm A), Erlotinib (150 mg PO QD) (Arm B) or placebo (for Erlotinib) QD (Arm C).
16184194|NCT01515137|Drug|Placebo|Erlotinib (150 mg PO QD) plus sulindac (150 mg PO BID) (Arm A), Erlotinib (150 mg PO QD) (Arm B) or placebo (for Erlotinib) QD (Arm C).
16184195|NCT01515124|Behavioral|Exercise Intervention|The Exercise Intervention combines the twice-weekly weight-lifting intervention from PAL with the 180 minutes of weekly aerobic exercise from the recently completed WISER trial and the ongoing WISER Sister Trial. Women will be trained by certified fitness professionals in both the PAL weight-lifting intervention and in safely increasing their aerobic exercise activity over 6 weekly sessions, and then monitored through phone contact, and monthly in-person sessions.
16184196|NCT01515124|Behavioral|Weight Loss Intervention|The Weight Loss Intervention begins with a 24 week intensive phase that includes weekly meetings and provision of all meals and snacks from a commercial manufacturer (NutriSystem, Inc., Fort Washington, PA). Daily caloric intake will be strictly controlled during this first 24 weeks at 1200-1500 calories per day.
16184197|NCT01515098|Dietary Supplement|Freeze-dried blueberries|Wild blueberries, freeze-dried and pulverized
16184198|NCT01515098|Dietary Supplement|Dextrose Placebo|Placebo developed to closely match blueberry powder.
16184199|NCT01515085|Procedure|laser interstitial thermal therapy|residual gliomas either after debulking or biopsy evaluated for intervention with laser ablation prior to onset of adjuvant therapy
16184200|NCT01515072|Other|RIPC (Remote Ischemic Preconditioning)|Remote Ischemic Preconditioning (RIPC) by Inflation of Pneumatic Tourniquet. The intervention will consist of tourniquet inflation on the mid-thigh for 5 minutes, followed by a deflation period of 5 minutes for a total of 4 cycles. The intervention will take place at two time points: First, after determination of brain death and consent for organ donation and again upon incision for organ recovery. The second intervention will occur in a manner identical to the first intervention but in the opposite limb.
16184201|NCT01515046|Drug|Gemcitabine with escalating ascorbic acid|"Gemcitabine 1000 mg/m2 weekly for 3 weeks with one week off (this is 1 cycle)
~Ascorbate dose is targeted to achieve plasma level of 350 mg/dL. Infusions are given twice weekly, each week of a cycle (4 weeks to a cycle)"
16184202|NCT01515033|Other|aerobic exercise training|"The continuous exercise training was performed on a treadmill with a 50-minutes duration and intensity at ventilatory anaerobic threshold.
~The interval exercise training consisted of 7 sets of 3 minutes at respiratory compensation point and 7 sets of 3 minutes of exercise at moderate intensity corresponding to the ventilatory anaerobic threshold totaling 42 minutes"
16184203|NCT01515020|Drug|vancomycin monotherapy|intravenous therapy by vancomycin
16184204|NCT01515020|Drug|daptomycin monotherapy|intravenous therapy by daptomycin
16184205|NCT01515007|Drug|Ciprofloxacin dispersion for inhalation|
16184206|NCT01515007|Drug|Placebo|
16184207|NCT01514994|Device|AngioScore's Valvuloplasty Scoring Balloon|All patients will receive treatment for their aortic valve stenosis with the Valvuloplasty Scoring Balloon Catheter.
16184208|NCT01514981|Drug|AMG 761|Single dose of AMG 761 on study day 1.
16184209|NCT01514981|Drug|Placebo|Single dose of placebo on study day 1.
16184210|NCT01514968|Drug|cyclosporine|Single oral dose
16184211|NCT01514968|Drug|danoprevir|Single oral dose
16184212|NCT01514968|Drug|ritonavir|Single oral dose
16184213|NCT01514955|Radiation|Gold seeds insertion to detect movements at pelvis|
16184214|NCT01514955|Radiation|Image guided MRI based RT (IMRT+Brachytherapy)|
16184215|NCT01514942|Dietary Supplement|Myo-inositol + Folic acid|Myo-inositol (2g) Folic acid (200mcg) (2 per day)
16184216|NCT01514942|Dietary Supplement|Myo-inositol + Folic acid|Myo-inositol (2g) Folic acid (200mcg) (2 per day)
16184217|NCT01514942|Dietary Supplement|D-chiro-inositol, manganese, folic acid, vit B12|D-Chiro-inositol (500 mg), manganese (1 mg), folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)
16184218|NCT01514942|Dietary Supplement|D-chiro-inositol, manganese, folic acid, vit B12|D-chiro-inositol (500 mg), manganese (1 mg), folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)
16184219|NCT01514942|Drug|Folic acid, vit B12|Folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)
16184220|NCT01514942|Drug|Folic acid, vit B12|Folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)
16184225|NCT01514916|Device|mechanical anastomosis without suture|The Vascular Join device is intended to be used to create sutureless end-to-end anastomosis between an artery and a venous or synthetic graft conduit. Any type of e-PTFE and Dacron conduits can be used.
16184226|NCT01514903|Drug|HIP0908|SINGLE DOSE , CROSS OVER
16184227|NCT01514903|Drug|viagra|single dose, cross over
16184228|NCT01514877|Drug|Icotinib|Patients will receive whole brain radiotherapy therapy 30Gy over 10 fractions and icotinib will be administered at the beginning of whole brain radiotherapy in doses of 125 mg thrice per day until disease progression or undue toxicity.
16184229|NCT01514864|Drug|Dasatinib|Tablet, oral, 140 mg, once daily until unacceptable toxicity or disease progression
16184230|NCT01514851|Drug|Lanthanum carbonate (BAY77-1931)|
16184231|NCT01514851|Drug|Calcium carbonate|
16184232|NCT01514838|Drug|ASP1941|oral
16184233|NCT01514838|Drug|acarbose|oral
16184234|NCT01514838|Drug|Placebo|oral, used only during placebo run-in period
16184235|NCT01514825|Drug|YM150|oral
16184236|NCT01514825|Drug|Placebo|oral
16184237|NCT01514812|Drug|YM150|oral - modified release formulation of YM150
16184238|NCT01514812|Drug|placebo|oral
16184239|NCT01514812|Drug|digoxin|oral
16184240|NCT01514799|Procedure|gastric bypass|two techniques of gastric bypass for studying the effects of making a long BP-limb
16184241|NCT01514786|Behavioral|Colorectal Web|The intervention arm will allow participants on Colorectal Web to manipulate their preferences for CRCS
16184242|NCT01514760|Other|Mobile-based Asthma Action Plan|"The participant will be distributed a mobile phone (iPhone or Android) at the time of consent. The mobile-based Asthma Action Plan application will be provided on the mobile device. The mobile phone based application features will include ambulatory peak flow and asthma symptoms diary, individualized treatment plan for routine care and during episodes of acute asthma symptoms, and education components to reinforce asthma self-management concepts. Participants will receive 3 daily messages from the Asthma Action Plan mobile application. A fourth rotating message will be sent twice weekly."
16184243|NCT01514734|Drug|Brinzolamide/timolol maleate fixed combination|Commercially marketed topical ocular agent for the treatment of open-angle glaucoma (OAG) or ocular hypertension.
16184244|NCT01514721|Drug|Travoprost/Timolol Maleate BAK-Free Fixed Combination|Commercially marketed Travoprost/Timolol BAK-free ophthalmic solution indicated for the treatment of patients with open angle glaucoma (OAG) or ocular hypertension (OH).
16184245|NCT01514708|Biological|AdimFlu-S Influenza Vaccine|Suspension for injection
16184246|NCT01514695|Drug|Midazolam|Starting with 1mg intravenously in all patients. More can be added at the discretion of the physician as needed for sedation.
16184247|NCT01514695|Drug|Fentanyl|100mcg intravenously given in 2mL syringe at start of procedure
16184248|NCT01514695|Other|Placebo|One dose of saline (2ml)
16184249|NCT01514682|Drug|Anti-inflammatory Combination Therapy|"salsalate: target dose 4 gm/day, administered in two divided doses of 2 gm in the morning and 2 gm in the evening
~fluvastatin: target dose 40 mg/day, administered in a single evening dose
~combined omega-3-fatty acid preparation of EPA and DHA; target dose EPA 2 gm/day and DHA 2 gm/day administered in a single evening dose"
16184250|NCT01514682|Drug|Placebo|Non-medication pills; To be taken in morning and evening intervals.
16184251|NCT01514656|Other|CPR Training using the Family and Friends CPR Anytime Video Self Instruction|Subjects will be trained using the American Heart Association's Family and Friends CPR Anytime Program. The subject's will undergo training in-hospital then they will be encouraged to take the training materials home with them to practice CPR with their family members and friends.
16184252|NCT01514656|Other|Implementation of a Hospital-based CPR Training Model|Nurses and Volunteers will be trained in the hospital-based CPR Training Model, and be encouraged to implement the training program in their respective hospitals.
16184253|NCT01514656|Other|Follow-up prompting to encourage skill retention|Subjects will be contacted every two months and encouraged to practice the skills that they have learned. Means of contact include: a) email b) text blasts c) phone calls d) social media e) mail
16184254|NCT01514630|Drug|Creatine monohydrate|Five grams of creatine monohydrate will be administered for eight weeks.
16184255|NCT01514617|Procedure|Diffusion -and perfusion weighted MRI including iv contrast agent injection|"MRI is a technique based on magnetic fields and does not require the use of ionizing radiation. Although there are no known side effects associated with MRI, a few precautions should be taken because of the 3T magnetic field. This implicates that all metal and magnetized objects must be removed from the patients before entering the MRI room. Patients with a pacemaker, a cardiac defibrillator or other implanted conductors/prostheses are for reason not eligible for the study.
~During the MRI examination, an intravenous contrast agent will be administered. In most cases, patients do not experience any discomfort and the use of this contrast agent is part of the clinical routine."
16184256|NCT01514578|Drug|TRV130A|Intravenous infusion of 1 hour duration
16184257|NCT01514578|Drug|Dextrose in Water|Intravenous infusion of 1 hour duration
16184258|NCT01514552|Other|Strawberry gummy|Randomized to consume 2 gummies (6 gram gummies each, total 12 grams/dose)four times daily for 7 days. Subjects will be randomized to either start with this strawberry intervention during intervention days 0 to 7 or during the crossover intervention on days 21 to 28.
16184259|NCT01514552|Other|Placebo control gummy|Randomized to consume 2 gummies (6 gram gummies each, total 12 grams/dose)four times daily for 7 days. Subjects will be randomized to either start with this a placebo gummy intervention during intervention days 0 to 7 or during the crossover intervention on days 21 to 28.
16184260|NCT01514539|Other|cross-sectional|"Monitoring two recently discovered appetite hormones called ghrelin and neuropeptide YY (PYY). This study evaluated whether fasting or postprandial ghrelin or PYY is different btween lactating and nonlactating postpartum women matched for age, body weight, and adiposity."
16184261|NCT01514526|Drug|Dovitinib|"Dovitinib (TKI-258), gelatin capsule of 100mg, developed and supplied by Novartis Inc. The study regimen consists of the administration of 500 mg / day (5 x 100mg) once daily, taken orally with a large amount of water, preferably one hour prior to a meal or at least two hours following a meal. This dose will be taken once daily according to 5 days on/2 days off schedule.
~The patient will continue on treatment until disease progression,unacceptable toxicity, death or premature withdrawal."
16184796|NCT01510574|Drug|placebo|3 x placebo tablets resembling misoprostol taken orally
16184262|NCT01514513|Drug|Licefreee Spray|Liquid applied to hair and left on for at least one hour once on day 1 and once on day 8 if live lice are present.
16184263|NCT01514513|Drug|1% permethrin creme rinse|Creme rinse applied to hair and rinsed off after 10 minutes once on day 1 and once on day 8 if live lice are present.
16184264|NCT01514500|Drug|somapacitan|Administered s.c. (subcutaneously, under the skin)
16184265|NCT01514500|Drug|placebo (somapacitan)|Single or multiple placebo doses administered s.c. (subcutaneously, under the skin)
16184266|NCT01514487|Drug|liraglutide|One single dose of 0.75 mg administered on three different dosing occasions with a 14-day wash-out period between each dosing. Injected subtaneously
16184267|NCT01514461|Drug|LCQ908|LCQ908 10 mg, LCQ908 20 mg, LCQ908 40 mg
16184268|NCT01514461|Drug|Placebo|LCQ908 10 mg, LCQ908 20 mg, LCQ908 40 mg
16184269|NCT01514448|Drug|Everolimus (RAD001)|Everolimus was used as commercially available formulated tablets of 10 mg strength
16184270|NCT01514435|Device|Electroconvulsive therapy|treatment for major depression
16184271|NCT01514435|Device|18-Fluoro-desoxy-glucose positron emission tomography|"intravenous injection of 18-FDG, after 30 min PET-Scan of the brain for aprox. 40 min.
~It´s a neuroimaging technique."
16184272|NCT01514422|Drug|Minocycline|Minocycline 100 to 300mg per day for 8 weeks
16184273|NCT01514409|Dietary Supplement|5-Hydroxytryptophan|"Thirty-three participants were randomly allocated in a double-blind manner to receive either 3x50mg capsules of 5-HTP or placebo (silica) for 14 days.
~5-HTP is produced commercially by extraction from the seeds of the African plant griffonia simplicifolia."
16184274|NCT01514409|Dietary Supplement|Pharmaceutical grade silica|Pharmaceutical grade silica was utilized as placebo
16184275|NCT01514396|Device|Surgiseal|surgical glue
16184276|NCT01514383|Device|Cyanoacrylate (Octylseal )|surgical adhesive
16184277|NCT01514370|Drug|IFN beta 1a 44 mcg TIW|Subjects received IFN beta 1a 44 microgram (mcg) subcutaneously TIW for 24 months.
16184278|NCT01514370|Drug|Curcumin|Subjects received 500 milligram (mg) curcumin orally twice a day for 24 months.
16184279|NCT01514370|Drug|Placebo|Subjects received placebo matched to curcumin orally twice a day for 24 months.
16184280|NCT01514357|Drug|Nesiritide (BNP)|NATRECOR® (nesiritide) is a sterile, purified preparation of human B-type natriuretic peptide (hBNP), and is manufactured from E. coli using recombinant DNA technology. Each 1.5 mg vial contains a white- to off-white lyophilized powder for intravenous (IV) administration after reconstitution.
16184281|NCT01514357|Drug|Placebo|Placebo will be administered subcutaneously instead of active drug (nesiritide) in a blind fashion in the second arm of the study.
16184282|NCT01514344|Drug|intralesional rituximab|10-20 mg (1-2 ml) rituximab once a week for 4 weeks; followed by 10-20 mg (1-2 ml) rituximab monthly per six months
16184283|NCT01514344|Biological|supplemental autologous serum|patients in PD or SD during or after administration of 6 doses monthly rituximab will be administered the same dose of intralesional rituximab supplemented by autologous serum
16184284|NCT01514331|Other|SIMV+VG mode of ventilation (synchronized intermittent mandatory ventilation+volume guarantee)|Neonates who need mechanical ventilation will be ventilated with SIMV+VG mode
16184285|NCT01514331|Other|PSV+VG (pressure support ventilation+volume guarantee)|Neonates who need mechanical ventilation will be ventilated with PSV+VG
16184286|NCT01514318|Device|Revelation Hip Stem (Revelation)|Subjects who received the Revelation Hip Stem prior to 2002 and still maintain the original device.
16184287|NCT01514292|Device|Continuous Glucose Monitoring of glucose levels (Dexcom)|Manipulation of glucose levels during multiple clinic days. Achieved through diet, exercise and insulin regimen defined in protocol.Evaluation of CGM performance characteristics in reference to a laboratory standard.
16184288|NCT01514279|Behavioral|HealthyCHANGE|"Cognitive behavioral strategies to address diet, physical activity, sedentary behavior and sleep for children.
~It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls."
16184289|NCT01514279|Behavioral|SystemCHANGE|"Intervention (based on systems improvement and choice architecture theories) System improvement and choice architecture theories seek to teach a set of skills using family self-designed experiments to redesign daily routines regarding eating, activity and sleep.
~It involves an intensive series of group sessions, followed by rotating monthly face-to-face meetings or phone calls."
16184290|NCT01514266|Drug|Curcumin+Bioprine|The intervention arm is Curcumin+Bioprine at escalating doses of 1 gram of Curcumin and 5 mg of Bioprine bid for one month, then 1.5 grams of Curcumin and 5 mg of bioprine bid for one month, and finally 2 grams of curcumin with 5 mg of bioprine bid for additional one month.
16184291|NCT01514266|Drug|Placebo|
16184292|NCT01514253|Drug|Glucose 25%|1 ml glucose 25%, once
16184293|NCT01514253|Dietary Supplement|Materna RTF Stage 1|1ml Materna RTF Phase 1, 2-3 minutes prior red-reflex examination.
16184294|NCT01514253|Other|Water for Injection|1 ml Water for Injection (WFI), 2-3 minutes prior red-reflex examination
16184295|NCT01514240|Drug|D9421-C capsule 3 mg|Patients randomised to D9421-C 9 mg will take 3 capsules of D9421-C capsule 3 mg once daily before breakfast and 4 tablets of Mesalazine tablets placebo three times a day after each meal for 8 weeks.
16184296|NCT01514240|Drug|Mesalazine tablets|Patients randomised to Mesalazine 3 g will take 3 capsules of D9421-C capsule placebo once daily before breakfast and 4 tablets of Mesalazine tablets 250 mg three times a day after each meal for 8 weeks.
16184297|NCT01514227|Drug|Aspirin or thienopyridine|Subjects randomized 6 month DAPT will be prescribed either aspirin or thienopyridine (clopidogrel or ticlopidine) following 6 months DAPT for the duration of study, which is left on the physician's discretion.
16184298|NCT01514227|Drug|Aspirin and thienopyridine|Subjects randomized 18 month DAPT will be prescribed both aspirin and thienopyridine (clopidogrel or ticlopidine) for 18 month after stenting.
16184299|NCT01514214|Device|WInged perimeter biliary stent insertion (Viaduct)|Insertion of a winged perimeter stent. Size to be determined during the ERCP based on findings.
16184300|NCT01514214|Device|traditional polyethylene stent insertion (Cotton Huibregtse)|insertion of a traditional polyethylene stent during ERCP, size to be determined depending on findings during ERCP
16184301|NCT01514201|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo 3D-CRT
16184302|NCT01514201|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16184303|NCT01514201|Other|Laboratory Biomarker Analysis|Optional correlative studies
16184307|NCT01514188|Drug|INNO-206|INNO-206 administered at 350 mg/m2 (260 mg/m2 doxorubicin equivalent) intravenously (IV) on Day 1 every 21 days for up to 6 consecutive cycles
16184308|NCT01514188|Drug|Doxorubicin|Doxorubicin administered at 75 mg/m2 for up to 6 consecutive cycles.
16184309|NCT01514175|Drug|IV Ibuprofen|Patients will be randomized to receive 800 mg intravenous ibuprofen or 30 mg ketorolac; each of the two treatment groups will consist of 25 patients.
16184310|NCT01514175|Drug|IV Ketorolac|Patients will be randomized to receive 800 mg intravenous ibuprofen or 30 mg ketorolac; each of the two treatment groups will consist of 25 patients.
16184311|NCT01514162|Device|Trifecta valve|surgical replacement of aortic valve
16184312|NCT01514149|Drug|CJC-1134-PC Injection|CJC-1134-PC administered weekly by subcutaneous injection
16184313|NCT01514149|Drug|Weekly placebo for CJC-1134-PC Injection|Weekly placebo for CJC-1134-PC administered weekly by subcutaneous injection
16184314|NCT01514136|Device|Ostomy appliance: convex 1-piece drainable|8 variations of an ostomy devices are tested
16184315|NCT01514123|Drug|VGX-100|VGX-100 will be administered by IV infusion once every week
16184316|NCT01514123|Drug|Bevacizumab|Bevacizumab will be administered by IV infusion once every 2 weeks
16184317|NCT01514110|Drug|RAD001|Pharmacology of RAD001 as a combination partner for conventional agents.
16184318|NCT01514071|Behavioral|Pop-up picture|"An animated picture depicting the key elements of the PECARN CT scan head injury rules will be explained. The picture will pop-up when a provider selects the order set for a CT scan due to head injury. Providers will need to select a box stating the patient either meets criteria or does not meet criteria in order to close the animated picture window."
16184319|NCT01514058|Procedure|EUS-FNA first, followed by CRCP with bilinary stenting|EUS-FNA first, followed by CRCP with bilinary stenting (using a plastic stent)
16184320|NCT01514058|Procedure|ERCP with stent placement, followed by EUS-FNA|ERCP with stent placement, followed by EUS-FNA
16184321|NCT01514032|Procedure|Extracorporal shockwave lithotripsy|Extracorporal shockwave lithotripsy
16184322|NCT01514032|Procedure|Retrograde intrarenal surgery|Retrograde intrarenal surgery
16184323|NCT01514019|Drug|Acebutolol|Acebutolol
16184324|NCT01514019|Drug|Placebo|Placebo capsule(Capsules filled up with lactose)
16184325|NCT01513993|Procedure|Telemonitoring for patients with Congestive Heart Failure|"Patients are equipped with a telemonitoring kit composed by a portable wrist-clinic device and digital weight scale for clinical parameters measuring and a gateway device for data transmission.
~The patient can monitor a complete set of clinical parameters, such as pulse-oxymetry, heart rate, blood pressure, ECG and body weight, with a frequency set by the clinician in the personalised treatment plan. Data are transmitted to a regional eHealth centre where a group of operators keeps these information under control and alerts the reference clinician in case of worsening of symptoms."
16184326|NCT01513980|Procedure|self-monitoring for patients with severe COPD|"Patients are equipped with a telemonitoring kit composed by a portable wrist-clinic device for clinical parameters measuring and a gateway device for data transmission.
~The patient can monitor pulse-oxymetry and heart rate with a frequency set by the clinician in the personalised treatment plan. Data are transmitted to a regional eHealth centre where a group of operators keeps these information under control and alert the reference clinician in case of worsening of symptoms. CAT questionnaire is monthly administrated by phone to the patients"
16184327|NCT01513980|Procedure|nurse-monitoring for patients with severe COPD|A nurse is in charge of data collection during home visits with a frequency set by the lung specialist depending to the patient clinical conditions. The nurse uses portable biomedical devices to measure pulse-oxymetry, heart rate, spirometry and if scheduled an arterial blood gas test. Data are transmitted to the clinician who checks them on his laptop in the hospital and completes the visit with the medical report.
16184328|NCT01513967|Drug|RPh201, botanical drug product|SC administration at varying doses
16184329|NCT01513967|Drug|Placebo|SC administration at varying doses
16184330|NCT01513941|Drug|Telaprevir|Type=exact number, unit=mg, number=750 or 1125, form=tablet, route=oral. the patients will receive 2 oral tablets every 8 hours for 12 weeks except for patients on efavirenz who will receive 1125mg (3 oral tablets) every 8 hours for 12 weeks.
16184331|NCT01513941|Drug|Ribavirin|Type=exact number, unit=mg, number=400, form=tablet, route=oral. The patients will receive 2 oral ribavirin tablets twice daily for 24 or 48 weeks, based on the response guided therapy.
16184332|NCT01513941|Drug|Pegylated-Interferon-alfa-2a|Type=exact number, unit=microgram, number=180, form=injection, route=subcutaneous The patients will receive Peg-IFN-alfa-2a 180 microgram once a week for 24 or 48 weeks; based on the response guided therapy.
16184333|NCT01513928|Drug|Pf-04937319|Formulation A) Pf-04937319 50 mg - administered as tablet
16184334|NCT01513928|Drug|Pf-04937319|Formulation B) Pf-04937319 50 mg - administered as capsule
16184335|NCT01513928|Drug|Pf-04937319|Formulation C) Pf-04937319 50 mg - administered as capsule
16184336|NCT01513915|Other|Group cognitive behavioral intervention|A Group cognitive behavioral intervention _based on parent training component of FRIENDS program_ was performed.The program protocol was translated to Persian, using the back translation method.The intervention was delivered in 6 two-hour weekly sessions. Two intervention groups ran, each group included 10 parents.The therapy was provided by an attending board certified child and adolescent psychiatrist and co lead by a fellow of child and adolescent psychiatry who distributed psychometric procedures and completed treatment adherence ratings.
16184337|NCT01513902|Drug|CP-690,550|CP-690,550 will be administered orally twice daily according to the dosing regimen provided below. Oral solution will be used for children weighing <40 kg. Oral tablets will be used for children weighing ≥40 kg. Children aged 12 to less than 18 years who are unable to swallow tablets will have the option of taking oral solution. Body Weight (kg) Dose (mg) Volume (mL) 5-11 1 1; 12-18 1.5 1.5; 19-24 2 2; 25-31 2.5 2.5; 32-39 3 3; ≥40 5 5
16184338|NCT01513902|Drug|CP-690,550|CP-690,550 will be administered orally twice daily according to the dosing regimen provided below. Oral solution will be used for children weighing <40 kg. Oral tablets will be used for children weighing ≥40 kg. Children less than 12 years of age with a body weight of ≥40 kg will have the option of taking oral solution or tablets. Body Weight (kg) Dose (mg) Volume (mL) 5-11 1 1; 12-18 1.5 1.5; 19-24 2 2; 25-31 2.5 2.5; 32-39 3 3; ≥40 5 5
16184475|NCT01512810|Procedure|Lymphadenectomy|Lymphadenectomy recommended, including: obturator, iliac (internal, external, common) and aortic lymph nodes
16184339|NCT01513902|Drug|CP-690,550|CP-690,550 will be administered orally twice daily according to the dosing regimen provided below. Children with a body weight ≥30 kg will have the option of taking oral solution or tablets, and children weighing <30 kg will be dosed with the oral solution. Body Weight (kg) Dose (mg) Volume (mL) 5-6 1 1; 7-9 1.5 1.5; 10-12 2 2; 21-15 2.5 2.5; 16-19 3 3; 20-22 3.5 3.5; 23-26 4 4; 27-29 4.5 4.5; ≥30 5 5
16184340|NCT01513863|Drug|Metronidazole Topical Gel 1%|Metronidazole Topical Gel 1% applied to affected area once a day for 70 days
16184341|NCT01513863|Drug|Metronidazole Topical Gel 1% (Metrogel)|Metronidazole Topical Gel 1% applied to affected area once a day for 70 days
16184342|NCT01513863|Drug|Placebo|Placebo applied to affected area once a day for 70 days
16184343|NCT01513850|Drug|Hepabulin IV|I.V.
16184344|NCT01513824|Behavioral|pressure pain sensitivity measure followed bu acupressure|twice daily measure of pressure pain sensitivity on the chest bone followed by stress management of which acupressure is mandatory.
16184345|NCT01513811|Drug|Polyethylene glycol electrolyte solutions|Patients received 2 packets of polyethylene glycol electrolyte solutions(PEG-E) without itopride.PEG-E was dissolved in 2 L of water. Patients were instructed to drink PEG solution 200ml every 10 min consumed the total 2 L solution in 2 hours.6 hours later, the colonoscopy was performed.
16184346|NCT01513811|Drug|Itopride and Polyethylene glycol electrolyte solutions|Patients were assigned to itopride 150mg, then 30 min later they were given 2 packets of polyethylene glycol electrolyte solutions(PEG-E). PEG-E was dissolved in 2 L of water. Patients were instructed to drink PEG solution 200ml every 10 min consumed the total 2 L solution in 2 hours. 6 hours later, the colonoscopy was performed.
16184347|NCT01513811|Drug|itopride and polyethylene glycol electrolyte solutions|Patients received itopride 150mg t.i.d(7am、12am、8pm) 24 hours before the examination day and another 150mg 30min before administration of polyethylene glycol electrolyte solutions(PEG-E).Two packets of PEG-E were dissolved in 2 L of water. Patients were instructed to drink PEG solution 200ml every 10 min and consumed the total 2 L solution in 2 hours. 6 hours later, the colonoscopies were performed.
16184348|NCT01513798|Behavioral|Modified paleolithic diet and exercise under observation|Modified paleolithic diet and exercise 3 session/week under observation
16184349|NCT01513798|Behavioral|Modified paleolithic diet and general advice on exercise|Modified paleolithic diet and general advice on exercise
16184350|NCT01513785|Drug|Rabeprazole and Amoxicillin|Amoxicillin (Zhuhai United Laboratories Co., Zhuhai, China) 1g t.i.d and Rabeprazole (Misato Plant of Eisai Co., Ltd. Japan) 10 mg b.i.d.for 14 days.
16184351|NCT01513785|Drug|Amoxicillin and Rabeprazole|Amoxicillin (Zhuhai United Laboratories Co., Zhuhai, China) 1 g t.i.d and Rabeprazole (Misato Plant of Eisai Co., Ltd. Japan) 20 mg b.i.d. for 14 days
16184352|NCT01513772|Drug|Dexmedetomidine|Dexmedetomidine(4㎍/mL) : 0.4㎍/kg/hr infusion until extubation
16184353|NCT01513772|Drug|Normal saline 0.9%|Normal saline(guess as 4㎍/mL) : 0.4㎍/kg/hr infusion until extubation
16184354|NCT01513759|Drug|recombinant tissue plasminogen activator|Participants will receive 24 mg of r-tPA delivered via the EkoSonic Endovascular Device.
16184355|NCT01513759|Device|EKOS EkoSonic Endovascular System|24 mg of r-tPA will be delivered through the EkoSonic Endovascular System.
16184356|NCT01513733|Drug|tasquinimod|tasquinimod 0.25 mg continuously
16184357|NCT01513733|Drug|tasquinimod 0.25 mg; 0.5 mg|tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg continuously, if tolerated
16184358|NCT01513733|Drug|tasquinimod 0.25 mg; 0.5 mg; 1.0 mg|tasquinimod 0.25 mg for 3 weeks followed by 0.5 mg for 3 weeks followed by 1.0 mg continuously, if tolerated
16184359|NCT01513720|Drug|Lamotrigine|Lamotrigine Tablets 200 mg
16184360|NCT01513720|Drug|Lamictal®|Lamictal® 200 mg Tablets
16184361|NCT01513694|Procedure|Instrumented posterolateral arthrodesis|"Cell suspension of mesenchymal stem cells (MSCs) obtained from bone marrow aspirate from the patient and expanded in vitro in a specific medium enriched with platelet lysate without addition of animal products.
~They used a minimum dose of 0.5 x106 CSM / kg and a maximum of 1, 5x106 CSM / kg of patient weight.
~Dosage Form: Suspension cell support hydroxyapatite and calcium phosphate Route of administration: placement in the fusion bed during surgery."
16184362|NCT01513681|Drug|Lamotrigine|Lamotrigine Tablets 200 mg
16184363|NCT01513681|Drug|Lamictal®|Lamictal® 200 mg Tablets
16184364|NCT01513668|Drug|Acetaminophen|Extended release Gel tabs 650 mg
16184365|NCT01513655|Device|LTNIV|LTNIV with the ventilator and the settings and pressures which reversed the respiratory failure and the hypercapnic acidosis. We know the patients are able to tolerate these settings. The ventilators are Philips A30. The patients must use the ventilator for a minimum of six hours a night.
16184366|NCT01513642|Behavioral|Breath Stacking|To perform the BS maneuver, a silicone mask containing a one-way valve was attached to the patient's face. Once the mask was adjusted to allow only inspiration (the expiratory branch remained occluded), the patient was asked to make successive inspiratory efforts during 20 seconds.
16184367|NCT01513616|Other|Pulmonary rehabilitation|8-week program, 3 supervised session per week
16184368|NCT01513616|Other|Usual care|An 8-week control period (includes optimization of respiratory medications, instructions on how best to manage COPD, standard access to treatment in the event of an exacerbation, self-management education)
16184369|NCT01513603|Drug|CLAG-M|IV times 5 days
16184370|NCT01513603|Drug|CLAG-M|Chemotherapy
16184371|NCT01513590|Drug|insulin degludec/insulin aspart|Administered s.c. (under the skin) twice daily. Dose individually adjusted. Pre-trial metformin treatment to be continued.
16184372|NCT01513577|Other|Pedicle screws|The control group received posterior fixation with pedicle screws through a midline approach. Through the approach bone was harvested from the right posterior iliac crest. Before closure of the posterior approach an epidural catheter and a drain was placed.
16184373|NCT01513577|Other|Percutaneous stab incisions|The intervention group received posterior fixation through 6 percutaneous stab incisions with the use of the sextant system. Through a separate 3-4 cm long incision, bone was harvested from the right posterior iliac crest. After decorticating the transverse processes through the stab wounds, the bone graft was placed with a 10 ml cut syringe. An epidural catheter was placed at the end of the posterior procedure.
16184374|NCT01513564|Drug|Postoperative epidural morphine|The control group received postoperative epidural morphine 0.4 mg/ml four times a day, epidural bupivacaine 2.5 mg/ml, 3-4 ml on request for 75 hours and a 7 day rehabilitation program.
16184375|NCT01513564|Drug|Local anaesthesia|Preemptively and posteruptively, the intervention group received local anaesthesia with bupivacaine 2.5 mg/ml, 10 + 10 ml posteriorly and 10 + 10 anteriorly; preemptive epidural analgesia with 3 ml lidocaine 20 mg/ml, 3 ml, 10 ml morphine 0.4 mg/ml plus 5 ml bupivacaine; postoperative continuous epidural analgesia for 72 hours with 250 ml with bupivacaine 1 mg/ml + morphine 50 ug/ml, and 0.5 ml epinephrine 1 mg/ml, 4 ml/hour, and after wound closure ketorolac 30 mg intravenously.
16184376|NCT01513551|Biological|Pneumococcal Conjugate Vaccine (V114)|15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), serotype 6B (4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.
16184377|NCT01513551|Biological|PNEUMOVAX® 23|23-valent pneumococcal polysaccharide vaccine with serotypes 1, 2, 3, 4, 5, 6B, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F (25 mcg each) in each 0.5 mL dose.
16184378|NCT01513551|Biological|PREVNAR 13®|13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F, serotype 6B (4.4 mcg each) and aluminum phosphate adjuvant (125 mcg) in each 0.5. mL dose.
16184379|NCT01513538|Device|TherapyGuide|Use of TherapyGuide function to help programming the device
16184380|NCT01513525|Drug|liraglutide|Single dose of 0.60 mg administered subcutaneously in three different injection sites on three separate dosing visits
16184381|NCT01513499|Drug|Oxytocin|Intranasal oxytocin 24 IU single-dose administration
16184382|NCT01513499|Drug|Placebo|Intranasal Placebo single-dose administration
16184383|NCT01513486|Behavioral|immobilization|
16184384|NCT01513473|Drug|insulin degludec|Injected subcutaneously (under the skin) once daily. Dose individually adjusted.
16184385|NCT01513473|Drug|insulin detemir|Injected subcutaneously (under the skin) once or twice daily. Dose individually adjusted.
16184386|NCT01513473|Drug|insulin aspart|Injected subcutaneously (under the skin) as mealtime bolus insulin. Dose individually adjusted.
16184387|NCT01513460|Drug|NVA237 50µg once daily|NVA237 50 μg o.d., delivered via single-dose dry-powder inhaler (SDDPI)
16184388|NCT01513460|Drug|Tiotropium 18µg once daily|Tiotropium 18 μg o.d. delivered via a proprietary inhalation device
16184389|NCT01513460|Drug|Flu/Sal|Flu/Sal 500/50 μg b.i.d. delivered via a proprietary inhalation device
16184390|NCT01513460|Drug|NVA237 placebo + Tiotropium placebo.|Tiotropium 18 μg o.d. delivered via a proprietary inhalation device
16184391|NCT01513447|Drug|Intracutaneous injections|Four intracutaneous injections: two sites lateral to the lumbosacral spine and two sites 2-3 centimeters below and 1- 2 centimeters medial to the original two injections sites. 0.1 millimeters of the study drug is injected between the dermal layers at each of the four sites. The injections are administered sequentially, with the series of four injections, performed two at a time, completed in 20-30 seconds.
16184392|NCT01513434|Procedure|transtibial technique|Femoral tunnel was made via tibial tunnel in anterior cruciate ligament reconstruction.
16184393|NCT01513434|Procedure|Transportal technique|Femoral tunnel was made via anteromedial portal in anterior cruciate ligament reconstruction.
16184394|NCT01513434|Procedure|anterior cruciate ligament reconstruction|femoral and tibial tunneling graft fixation on the femoral side with endobutton and on the tibial side with post-tie and interference screw
16184395|NCT01513421|Procedure|Percutaneous drainage of intra-abdominal collection|"Percutaneous drainage of infected intra-abdominal collection Under computed tomography or ultrasound guidance.
~Procedures perform by a board certified interventional radiologist"
16184396|NCT01513408|Other|immunohistochemical detection of lymphocytes T CD8+/Foxp3 ratio|For each patients included the study, a tumour block from the initial biopsy, as well as a representative block of residual tumour (area of complete tumoral regression, area of partial tumoral regression or area of unmodified residual tumour) will be chosen by the initial pathologist in each investigating centre. Once the pathologist has verified the concordance between the images observed on the blocks sent from the investigating centres, and the associated pathology reports, immunohistochemical analysis will be performed on the slides prepared from each block.
16184397|NCT01513395|Behavioral|Interval bladder emptying|"Participants randomized to the Interval arm (cervical assessment 15 minutes or more after voiding) will be notified of their allocation and asked to immediately use the rest room and attempt to void completely. A synchronized clock will be located in this restroom, and each participant will be asked to note the time that she completes voiding. This will be confirmed by the research staff by noting the time the participant enters and exits the restroom. The participant will return to the waiting room or ultrasound room. Any indicated trans-abdominal ultrasound imaging will be performed, and preparations will be made for the vaginal ultrasound. The participant will be asked not to void prior to the vaginal ultrasound. Cervical assessment will take place at a minimum of 15 minutes from voiding time."
16184398|NCT01513382|Procedure|Pilonidal sinus excision|The dyed portion of the excised pilonidal sinus and non-dyed cavity excision specimen will be studied histopathologically to detect any remnant of pilonidal sinus.
16184399|NCT01513369|Drug|ferric carboxymaltose|Dose:according to SmPC Duration: 12 weeks; Frequency: at week 1 and again at week 5 (if again indicated according to principal inclusion criteria); Application: intravenous
16184400|NCT01513369|Drug|NaCl (0,9%)|Duration: 12 weeks; Frequency: at week 1 and again at week 5 (if again indicated according to principal inclusion criteria); Application: intravenous
16184401|NCT01513356|Drug|BKM120|BKM120 will be administered on a continuous once daily dosing schedule at a dose of 100 mg (p.o.)until progression of disease or unacceptable toxicity or a maximum of 4 weeks.
16184402|NCT01513343|Behavioral|Parent and child groups focused on self-regulation of eating|
16184403|NCT01513330|Device|SenSura Mio|Ostomy product - 1 piece closed bag
16184404|NCT01513330|Device|Standard Care|Ostomy product 1 piece closed bags. Either SenSura, Nova 1, Moderna/Moderna Flex, Esteem or Flexima/Softima.
16184405|NCT01513317|Drug|Siltuximab|15 mg/kg administered as a 1-hour intravenous infusion every 4 weeks
16184406|NCT01513317|Drug|Placebo|Administered as a 1-hour intravenous infusion every 4 weeks
16184407|NCT01513317|Drug|Best supportive care (BSC)|Best supportive care according to local standards and guidelines
16184408|NCT01513304|Procedure|Manual therapy|
16184409|NCT01513291|Drug|MK-6096|MK-6096, two 5 mg tablets (total 10 mg dose), orally, once daily
16184410|NCT01513291|Drug|Placebo|Placebo, 2 tablets, orally, once daily
16184411|NCT01513278|Drug|APN201|"All patients receive APN201 and placebo at the same time. The irradiated region is divided vertically into two symmetric areas (left and right). One area is treated with APN201 (recombinant human superoxide dismutase (rhSOD) encapsulated in liposomal vesicles formulated as a hydrophilic gel; 1.6 mg rhSOD per mL), the other area is treated with placebo (empty liposomes formulated as a hydrophilic gel) in a double-blind fashion.
~Study treatment (APN201 and placebo) starts on the day of initiation of radiation therapy and continues until the end of radiation therapy to the whole breast (25 or 28 daily fractions to a total dose of 50.0 Gy or 50.4 Gy, respectively). Study treatment is applied as a thin film on the irradiated area ≥10 minutes each day before radiation therapy (approximately 1 mL APN201 per 100 cm2 of the radiation field size and approximately 1 ml placebo per 100 cm2 of the radiation field size)."
16184412|NCT01513278|Drug|Placebo|"All patients receive APN201 and placebo at the same time. The irradiated region is divided vertically into two symmetric areas (left and right). One area is treated with APN201 (recombinant human superoxide dismutase (rhSOD) encapsulated in liposomal vesicles formulated as a hydrophilic gel; 1.6 mg rhSOD per mL), the other area is treated with placebo (empty liposomes formulated as a hydrophilic gel) in a double-blind fashion.
~Study treatment (APN201 and placebo) starts on the day of initiation of radiation therapy and continues until the end of radiation therapy to the whole breast (25 or 28 daily fractions to a total dose of 50.0 Gy or 50.4 Gy, respectively). Study treatment is applied as a thin film on the irradiated area ≥10 minutes each day before radiation therapy (approximately 1 mL APN201 per 100 cm2 of the radiation field size and approximately 1 ml placebo per 100 cm2 of the radiation field size)."
16184413|NCT01513265|Other|Pharmaceutical care plan, mostly based on the RASP|Drug use of subjects enrolled in this arm will be systematically evaluated by a clinical pharmacist, using the RASP list. Potentially inappropriate drug use will be pointed out to the treating physician. The pharmaceutical advice is not limited to the RASP list. Any actual change in drug prescription will be decided by the treating physician based upon comprehensive medical evaluations in each individual patient.
16184414|NCT01513252|Behavioral|Gröber and Buschke test|spontaneous delayed recall score after a 5 years follow-up
16184415|NCT01513239|Biological|MK-6072|Single IV infusion of MK-6072 (10 mg/kg of monoclonal antibody to C. difficile Toxin B)
16184416|NCT01513239|Biological|MK-3415A|Single IV infusion of MK-3415A (10 mg/kg of monoclonal antibody to C. difficile Toxin A and 10 mg/kg of monoclonal antibody to C. difficile Toxin B)
16184417|NCT01513239|Biological|Placebo|Single IV infusion of normal saline (0.9% sodium chloride)
16184418|NCT01513239|Drug|SOC|SOC for CDI will be prescribed for 10 to 14 days and can begin on the day of study drug infusion; but the first dose must have been administered prior to or within a few hours following study drug infusion. SOC is defined as the receipt of oral metronidazole, oral vancomycin, IV metronidazole concurrent with oral vancomycin, oral fidaxomicin, or oral fidaxomicin concurrent with IV metronidazole.
16184419|NCT01513226|Other|Cycled light|lights on at daytime, lights off at nighttime
16184420|NCT01513200|Drug|Unfractionated heparin (UFH)|UFH solution for infusion Initially 60U/kg bolus followed by intravenous infusion (12U/kg/hr) for approximately 11 hours
16184421|NCT01513200|Drug|Bendavia|Bendavia for infusion Constant intravenous infusion (Bendavia 0.25mg/kg/hr) for 4 hours
16184422|NCT01513200|Drug|Saline (0.9%, sterile, for infusion)|Saline (placebo) Constant IV infusion for 4 hours
16184423|NCT01513187|Drug|Pazopanib + interferon alpha 2A|"Five levels of pazopanib in different doses: 400, 600 and 800 mg / day and interferon alfa 2-A 3, 6 and 9 MIU three times a week, in cycles of 28 days.
~Treatment will continue until disease progression, unacceptable toxicity, non-compliance or withdrawal of consent by the patient"
16184424|NCT01513174|Drug|Gefitinib|Gefitinib 250 mg once a day, continuously, in 28-day cycles, until progression
16184425|NCT01513174|Drug|Gefitinib plus olaparib|Gefitinib 250 mg once a day, in combination with olaparib (at the recommended dose in the previous Phase Ib study) twice a day, continuously, in 28-day cycles.
16184426|NCT01513161|Drug|nalfurafine hydrochloride (TRK-820)|Soft capsule containing 2.5ug nalfurafine hydrochloride. Start with 2.5ug of oral administraion once daily, and can be increased up to 5ug if necessary.
16184427|NCT01513161|Drug|Placebo|
16184428|NCT01513148|Device|Superluminous light diode|900W, 880nm, 1.6 J/cm2 for 30sec
16184429|NCT01513135|Biological|Tat|Recombinant biologically active Tat 30 mcg in Phosphate saline buffer, pH 7.4, 1% sucrose, 1% Human Serum Albumin
16184430|NCT01513135|Biological|Placebo|Phosphate saline buffer, pH 7.4, 1% sucrose, 1% Human Serum Albumin
16184431|NCT01513122|Drug|Lopinavir / ritonavir|LPV/r 200mg/50mg 4 tabs once daily or 2 tabs twice daily
16184432|NCT01513122|Drug|2-3N(t)RTI|
16184433|NCT01513122|Drug|raltegravir|raltegravir 400mg 1 tablet twice daily.
16184434|NCT01513109|Biological|Recombinant WT1 Antigen-Specific Cancer Immunotherapeutic (ASCI)|i.m. administration
16184435|NCT01513096|Drug|itopride|itopride, 10mg, twice per day, for 1 day
16184436|NCT01513083|Drug|trastuzumab emtansine|Multiple intravenous doses
16184437|NCT01513070|Drug|Quick-Acting Heart Reliever|Quick-Acting Heart Reliever，200mg，tid，po. for six months
16184438|NCT01513070|Drug|Isosorbide Dinitrate|Isosorbide Dinitrate，10mg，tid，po. for six months
16184439|NCT01513070|Drug|Placebo of Isosorbide Dinitrate|Placebo of Isosorbide Dinitrate，10mg，tid，po. for six months
16184440|NCT01513070|Drug|Aspirin Enteric-coated Tablets|Aspirin Enteric-coated Tablets，100mg，qd，po. for six months
16184441|NCT01513070|Drug|Placebo of Quick-Acting Heart Reliever|Placebo of Quick-Acting Heart Reliever，200mg，tid，po. for six months
16184442|NCT01513070|Drug|Aspirin Enteric-coated Tablets|Aspirin Enteric-coated Tablets，100mg，qd，po. for six months
16184443|NCT01513057|Drug|Mycophenolate Mofetil|Mycophenolate Mofetil 250 mg capsules of Dr. Reddy's Laboratories Limited
16184444|NCT01513057|Drug|Mycophenolate Mofetil|250 mg capsules of Roche Laboratories Inc.
16184445|NCT01513044|Drug|Mycophenolate Mofetil|Mycophenolate Mofetil 250 mg capsules of Dr. Reddy's Laboratories Limited
16184446|NCT01513044|Drug|Mycophenolate Mofetil|250 mg capsules of Roche Laboratories Inc.
16184447|NCT01513031|Other|Education and telephone follow-up|Education related to anti-arrhythmic therapy and monthly telephone follow-up to assess adherence to medication.
16184476|NCT01512797|Drug|Sitagliptin phosphate|100 mg/day orally
16184477|NCT01512797|Other|Placebo|1 Placebo Pill per day
16184448|NCT01513018|Other|high tidal volumes|"One-lung ventilation was started at skin incision using a volume-controlled square-wave flow pattern. Patients were randomly assigned to 30 minutes of ventilation with a tidal volume of 10 ml/kg tidal volume without external PEEP and respiratory rate of 10 breaths/minute (n=50) or to a tidal volume of 5 ml/kg with 5 cmH2O PEEP and a respiratory rate of 20 breaths/minute (n=50). Minute volume was thus kept constant during each experimental condition.
~Randomization was based on computer-generated codes that were maintained in sequentially numbered sealed opaque envelopes until after induction of anesthesia. During the subsequent 30 minutes of one-lung ventilation, the alternative ventilatory management was used."
16184449|NCT01513018|Other|low tidal volume|"One-lung ventilation was started at skin incision using a volume-controlled square-wave flow pattern. Patients were randomly assigned to 30 minutes of ventilation with a tidal volume of 10 ml/kg tidal volume without external PEEP and respiratory rate of 10 breaths/minute (n=50) or to a tidal volume of 5 ml/kg with 5 cmH2O PEEP and a respiratory rate of 20 breaths/minute (n=50). Minute volume was thus kept constant during each experimental condition.
~Randomization was based on computer-generated codes that were maintained in sequentially numbered sealed opaque envelopes until after induction of anesthesia. During the subsequent 30 minutes of one-lung ventilation, the alternative ventilatory management was used."
16184450|NCT01513005|Procedure|Laparoscopic Sleeve Gastrectomy|"the operative technique consists in few steps:
~position of 4 trocars and insertion of a nasogastric tube
~dissection and mobilization of the greater curvature of the stomach
~preparation of the stomach for division
~gastric partition
~extraction of the gastric remnant
~postoperative surveillance"
16184451|NCT01512992|Procedure|Home telehealth|"Patients receive tailored intervention according to their clinical complexity.
~All patients in the intervention group receive:
~Personalised care plan
~Education on self-management
~Access to a personalized online health folder
~Access to Call center
~Access to primary care and hospital specialists; follow-up visits for evaluation of clinical recovery and care plan adjustments (if needed).
~Patients with LOW complexity additionally receive:
~Daily videoconferences for the 1st week after discharge
~Remote monitoring for respiratory parameters. Sensors are selected on an individual basis by the medical specialists.
~Patients with HIGH complexity additionally receive:
~Videoconferences for at least 1 month after discharge, scheduled on an individual basis.
~Remote monitoring for respiratory parameters.
~One monthly phone call from the call centre to promote and assess patient self-management."
16184452|NCT01512979|Drug|metformin|1000 mg to 2000 mg per day
16184453|NCT01512979|Drug|linagliptin|5 mg daily
16184454|NCT01512979|Drug|metformin placebo|0 to 2 tablets daily
16184455|NCT01512979|Drug|metformin placebo|4 tablets daily
16184456|NCT01512966|Biological|VEGF Trap-Eye (BAY86-5321)|Subjects in the VEGF Trap-Eye group will receive intravitreal injections every 8 weeks following a loading phase with injections given every 4 weeks. The overall treatment period is 48 weeks.
16184457|NCT01512953|Drug|Lansoprazole|Lansoprazole 30 mg once a day
16184458|NCT01512940|Procedure|Laparoscopic Greater Curvature Plication|"The greater curvature of the stomach is separated from the greater omentum. At least two rows of at least five continuous stitches will be placed about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure. The two tissue bites of an individual stitch will be centered about the intended fold line.
~Subsequent stitches will be uniformly spaced distally along the length of the fold. The second row of sutures will be placed across the fold line created by the previous row of sutures in the same fashion as the first row. Up to 2 additional rows may be added as required to achieve this result (for a total of up to 4 rows). Upon completion of the procedure, the section of the stomach infolded by the sutures will be inspected using the endoscope."
16184459|NCT01512914|Drug|Ropivacaine 30 mg|preoperative instillation of saline 20 ml, nebulization of ropivacaine 1% 3 ml (30 mg) before surgery and nebulization of saline 3 ml after surgery
16184460|NCT01512914|Drug|Ropivacaine 30 mg|preoperative instillation of saline 20 ml, preoperative nebulization of saline 3 ml and nebulization of ropivacaine 1% 3 ml (30 mg) after surgery
16184461|NCT01512914|Drug|Ropivacaine 100 mg|preoperative instillation of ropivacaine 0,5% 20 ml (100 mg) and nebulization of saline 3 ml before and after surgery
16184462|NCT01512914|Drug|saline|preoperative instillation of saline 20 ml and nebulization of saline before and after surgery
16184463|NCT01512901|Drug|Betamethasone Microsphere (DE-102） Low Dose|
16184464|NCT01512901|Drug|Betamethasone Microsphere (DE-102） High Dose|
16184465|NCT01512901|Drug|Sham|
16184466|NCT01512888|Genetic|CL20-i4-EF1α-hγc-OPT|Participants will undergo infusion with autologous CD34+ bone marrow cells transduced with a lentiviral vector that contains a normal copy of the human γc gene.
16184467|NCT01512888|Drug|Busulfan|Given intravenously (IV).
16184468|NCT01512888|Device|CliniMacs|Isolation and purification of CD34+ stem cells will be done after the unmodified frozen backup is obtained and in accordance with our FDA IND and in accordance with the CliniMacs manual of operations.
16184469|NCT01512862|Drug|Calcitriol|Dosage of 0.25 mcg administered orally once daily for 6 weeks and dose escalated to 0.5 mcg orally once daily up to 6 months
16184470|NCT01512862|Drug|Placebo|Dosage of 0.25 mcg administered orally once daily for 6 weeks and dose escalated to 0.5 mcg orally once daily up to 6 months
16184471|NCT01512849|Drug|TA-7284 Low|Low
16184472|NCT01512849|Drug|TA-7284 High|High
16184473|NCT01512836|Behavioral|Case Management|"Patients, who are randomized to the intervention group, will receive case management from a trained and experienced nurse. The case manager will carry out following tasks:
~Formulation and implementation of care plans together with the patient
~Monitoring of individual status and care plan effectuation
~Overall coordination between health care providers
~Support to the patient and their caregivers during times of transition related to health status and environmental changes (e.g. hospital to home)
~Regular telephone consultations and home visits
~Promote disease-self management through coaching"
16184474|NCT01512823|Behavioral|Education|"Interactive educational intervention:
~4 hour education session (with notes and 'evidence packs'); presentations, small group discussion tasks and practice of particular skills - 2 hour session (1 week later)
~Emailed notes from second session
~Telephonic/email follow-up (reminders)
~Didactic educational intervention:
~- 4 hour education session (with notes and 'evidence packs'; questions answered but no discussion or application of skills"
16184638|NCT01511640|Drug|Placebo|placebo 2x daily for duration of study
16184478|NCT01512784|Biological|Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ®)|"Human Papillomavirus vaccine (types 6, 11, 16 and 18) (Recombinant, adsorbed).
~Each dose of Gardasil suspension for injection contains 0,5 ml. The shot is usually given in the arm muscle, 3 shots are given on the following schedule:
~First dose: at chosen date. Second dose: 2 months after dose 1. Third dose: 6 months after dose 1.
~Ingredients: highly purified non-infectious protein for each of the Human Papillomavirus types (6, 11, 16 and 18). Each dose (0,5ml) contains approximately:
~Human Papillomavirus type 6 L1 protein 20 micrograms. Human Papillomavirus type 11 L1 protein 40 micrograms. Human Papillomavirus type 16 L1 protein 40 micrograms. Human Papillomavirus type 18 L1 protein 20 micrograms."
16184479|NCT01512784|Biological|Quadrivalent Human Papillomavirus (6, 11, 16 and 18) vaccine (Gardasil ®)|"Human Papillomavirus vaccine (types 6, 11, 16 and 18) (Recombinant, adsorbed).
~Each dose of Gardasil suspension for injection contains 0,5 ml. The shot is usually given in the arm muscle, 3 shots are given on the following schedule:
~first dose: at chosen date. Second dose: 2 months after dose 1. Third dose: 6 months after dose 1.
~Ingredients: highly purified non-infectious protein for each of the Human Papillomavirus types (6, 11, 16 and 18). Each dose (0,5ml) contains approximately:
~Human Papillomavirus type 6 L1 protein 20 micrograms. Human Papillomavirus type 11 L1 protein 40 micrograms. Human Papillomavirus type 16 L1 protein 40 micrograms. Human Papillomavirus type 18 L1 protein 20 micrograms."
16184480|NCT01512771|Other|CPAP|6 weeks of CPAP
16184481|NCT01512758|Drug|Alisertib|Alisertib enteric-coated tablets
16184482|NCT01512745|Drug|apatinib|apatinib 850 mg qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
16184483|NCT01512745|Drug|placebo|placebo qd p.o. until disease progression or intolerable toxicity or patients withdrawal of consent
16184484|NCT01512719|Procedure|POEM|Per Oral Endoscopic Myotomy for achalasia
16184485|NCT01512706|Biological|160Eu/0.5ml in infants (6-11 months old)|inactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 60 infants aged 6-11 months old on day 0, 28
16184486|NCT01512706|Biological|320Eu/0.5ml in infants (6-11 months old)|inactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 60 infants aged 6-11 months old on day 0, 28
16184487|NCT01512706|Biological|640Eu/0.5ml in infants (6-11 months old)|inactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 40 infants aged 6-11 months old on day 0, 28
16184488|NCT01512706|Biological|1280Eu/0.5ml (without adjuvant) in infants (6-11 months old)|inactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml (without adjuvant) in 40 infants aged 6-11 months old on day 0, 28
16184489|NCT01512706|Biological|0Eu/0.5ml in infants (6-11 months old)|0Eu/0.5ml placebo in 80 infants aged 6-11 months old on day 0, 28
16184490|NCT01512706|Biological|160Eu/0.5ml in infants (12-23 months old)|inactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 30 infants aged 12-23 months old on day 0, 28
16184491|NCT01512706|Biological|320Eu/0.5ml in infants (12-23 months old)|inactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 30 infants aged 12-23 months old on day 0, 28
16184492|NCT01512706|Biological|640Eu/0.5ml in infants (12-23 months old)|inactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 40 infants aged 12-23 months old on day 0, 28
16184493|NCT01512706|Biological|1280Eu/0.5ml (without adjuvant) in infants (12-23 months old)|inactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml (without adjuvant) in 40 infants aged 12-23 months old on day 0, 28
16184494|NCT01512706|Biological|0Eu/0.5ml in infants (12-23 months old)|0Eu/0.5ml placebo in 50 infants aged 12-23 months old on day 0, 28
16184495|NCT01512706|Biological|160Eu/0.5ml in children (24 months-5 years old)|inactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 30 children aged 24 months-5 years months old on day 0, 28
16184496|NCT01512706|Biological|320Eu/0.5ml in children (24 months-5 years old)|inactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 30 children aged 24 months-5 years months old on day 0, 28
16184497|NCT01512706|Biological|640Eu/0.5ml in children (24 months-5 years old)|inactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 40 children aged 24 months-5 years months old on day 0, 28
16184498|NCT01512706|Biological|1280Eu/0.5ml (without adjuvant) in children (24 months-5 years old)|inactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml in 40 children aged 24 months-5 years months old on day 0, 28
16184499|NCT01512706|Biological|0Eu/0.5ml in children (24 months-5 years old)|0Eu/0.5ml placebo in 50 children aged 24 months-5 years old on day 0, 28
16184500|NCT01512693|Drug|MK-0822|A single oral dose (50 mg tablet) of MK 0822 will be administered on Day 1 after an overnight fast.
16184501|NCT01512680|Behavioral|Education to Functional Insulin Therapy|"Intake of Continuous Glucose Monitor for 5 to 7 days
~Functional Insulinotherapy training during 3 days, blood sampling, autoevaluation and QOL questionnary.
~1 month after the training: Follow-up consultation, clinical exam, vital signs and data on diabetes
~3 months after the training: Blood sampling, vital signs and data on diabetes
~6 months after the training: 2 sessions of training, blood sampling, autoevaluation and QOL questionnary, vital signs and data on diabetes, Intake of Continuous Glucose Monitor for 5 to 7 days
~9 months after the training: Blood sampling, vital signs and data on diabetes
~1 to 3 weeks before last visit: Intake of Continuous Glucose Monitor for 5 to 7 days
~12 months after the training: Follow-up consultation, clinical exam, vital signs and data on diabetes, autoevaluation and QOL questionnary"
16184502|NCT01512667|Drug|MK-0822|A single oral dose (50 mg tablet) of MK-0822 will be administered on Day 1 after an overnight fast.
16184505|NCT01512641|Other|Primary stage|Kiddie-Schedule for Affective Disorders and Schizophrenia
16184677|NCT01511419|Biological|placebo|2 doses of placebo
16184506|NCT01512641|Other|Secondary stage|children who are positive to the kiddie-SADS (primary stage), will take the tests: PANSS, Scale for the Assessment of Negative Symptoms (SANS), ADI-R, scale TLC and WISC IV
16184507|NCT01512628|Drug|Pentaspan, voluven, volulyte|Different colloids are administered during operation for replacement of blood loss before the transfusion of blood.
16184508|NCT01512615|Other|Complex Cardiac rehabilitation|Complex Cardiac Rehabilitation consisting of exercise training (minimum 3 times a week for a total of twelve weeks) and psychoeducational care (5 sessions over 6 months)
16184509|NCT01512615|Other|Control group|Usual care, clinical control as provided by treating heart centre
16184510|NCT01512602|Behavioral|DBT|16 weeks DBT treatment
16184511|NCT01512602|Behavioral|CAMS|CAMS-informed psychotherapy
16184515|NCT01512576|Other|acupuncture|one 30-minute treatment session using sterile 1-time-use needles (Euro-acupuncture needles) were used, but the therapist was allowed to chose the needle length and diameter
16184516|NCT01512576|Behavioral|relaxation|1 treatment session of 30 minutes
16184517|NCT01512563|Device|Biliary stent|palliative treatment for malignant patients
16184518|NCT01512550|Procedure|GF hip guide|Using GF hip guide to measure and control the peroperative positioning of the hip stem
16184519|NCT01512550|Procedure|Stryker Navigation System|Using Orthomap Modular Hip Software to navigate the operation
16184520|NCT01512550|Device|ABG II modular femoral component|A hip prosthesis made by Stryker. It has the same basic shape as the ABG II femoral component but has a modular neck system allowing it to better follow the patient specific hip anatomy regarding offset, varus-valgus angle and rotation in the anteroposterior plane.
16184521|NCT01512537|Radiation|Narrowband UVB|UVB 3 times a week
16184522|NCT01512537|Dietary Supplement|Vitamin D and calcium|1 daily tablet of 1600 IU vitamin D3 and 1000 mg calcium
16184523|NCT01512524|Other|MRI scan and endocrinology analysis|Endocrinology analysis including statique and dynamic exams, neuropsychologic evaluations and IRM scan.
16184524|NCT01512511|Procedure|nitrous oxide use for pneumoperitoneum creation|use nitrous oxide for create pneumoperitoneum in laparoscopic cholecystectomy
16184525|NCT01512485|Drug|Clopidogrel|Clopidogrel Tablets 75 mg
16184526|NCT01512472|Drug|degarelix|Starting dose of 240 mg (40 mg/mL; injection volume 2 x 3 mL; s.c.) degarelix one-month depot will be administered sc on Day 0, followed by a maintenance dose of 80 mg (20 mg/mL; injection volume 1 x 4 mL; s.c.) sc degarelix one-month depot will be administered into the anterior abdominal wall on Month 1, 2, 3, 4, 5, 6, 7, 8 and 9 for the 10 month arm and month 1, 2 and 3 for the 4 month arm.
16184527|NCT01512459|Drug|Venlafaxine|Venlafaxine MR Capsules 150 mg
16184528|NCT01512446|Drug|Alendronate|70 mg per week
16184529|NCT01512446|Drug|Placebo|1 pill per week
16184530|NCT01512433|Procedure|Ture acupuncture|Ture acupuncture included shenmen point in the ear cartilage ridge area without electrical stimulation and Hegu (LI 4) and Zusanli (ST 36) on both hands and legs with electrical stimulation. The frequency of stimulation alternated between 20 and 100 Hz (dense and disperse, DD) at automatic 2-second intervals. The intensities of the stimulations were increased in 1 mA increments to maximal tolerable intensity.
16184531|NCT01512433|Procedure|Sham acupuncture|"The needles on the bilateral Hegu (LI 4) and Zusanli (ST 36) were then connected to the electro-acupuncture machine with zero frequencies and amplitude.DeQiwas avoided during needling."
16184532|NCT01512407|Procedure|Transarterial chemoembolisation using cisplatin-lipiodol mixture|Cisplatin-lipiodol mixture was infused through catheter placed at hepatic artery followed by gelfoam embolisation. This is performed 4 to 6 weeks after surgery
16184533|NCT01512394|Procedure|standard bowel prep|standard bowel prep
16184534|NCT01512394|Procedure|no bowel prep|no bowel prep
16184535|NCT01512381|Device|Implantation of CRT device|RV lead of CRT system is implanted into the middle part of interventricular septum
16184536|NCT01512381|Device|Implantation of conventional VVI(R) pacemaker|RV lead is implanted into the middle part of interventricular septum
16184537|NCT01512368|Other|Supervised Exercising|A treadmill exercise test (following the Bruce's protocol) was done five times per week (from Monday to Friday) for two weeks.
16184538|NCT01512355|Drug|Dexmedetomidine|After, induction of general anesthesia, dexmedetomidine 0.2 mcg/kg/hr continuous intravenous infused during the surgery
16184539|NCT01512355|Drug|placebo group|normal saline_02mcg/kg/hr
16184540|NCT01512342|Behavioral|Pacing|3 one-on-one sessions weekly for 3 consecutive weeks
16184541|NCT01512342|Behavioral|relaxation therapy|3 one-on-one sessions weekly for 3 consecutive weeks
16184542|NCT01512329|Behavioral|pacing|3 one-on-one sessions weekly for 3 consecutive weeks
16184543|NCT01512329|Behavioral|relaxation|3 one-on-one sessions weekly for 3 consecutive weeks
16184544|NCT01512316|Drug|d-Cycloserine|250mg, one dose, 2hrs prior to fMRI
16184545|NCT01512316|Drug|Lactose pill|one dose, 2hrs prior to fmri
16184546|NCT01512316|Genetic|Saliva sample|Buccal cell material will be sampled from all participants on day3
16184547|NCT01512316|Other|Functional neuroimaging (fMRI)|
16184548|NCT01512303|Behavioral|Sudarshan Kriya Yoga|SKY incorporates yoga, discussion periods and several types of breathing exercises for relaxation.
16184549|NCT01512303|Behavioral|Mindfulness-Based Stress Reduction|MBSR incorporates yoga, discussion periods, and several types of meditation, all involving attention to the present moment and acceptance of any feelings, sensations or thoughts
16184550|NCT01512290|Other|Theta Burst Transcranial Magnetic Stimulation|This rTMS paradigm consists of 5 pulses at 50Hz repeated at 5Hz for 60 seconds with a total of 900 pulses per treatment
16184551|NCT01512277|Biological|rSh28GST|subcutaneous route at Day 0, Day 28, and Day 150 for the third administration of 100µg for Arm 1
16184552|NCT01512264|Device|Magstim SuperRapid|This design will allow systematic evaluation of the efficacy of nerTMS and its most optimal dose for language recovery.
16184553|NCT01512251|Drug|BKM120 Combined with Vemurafenib (PLX4032)|"Phase I is 3+3 dose escalation study to identify the recommended phase 2 dose (RP2D)
~Dose Level -1: BKM120 60 mg daily, Vemurafenib 480 mg bid
~Dose Level 1: BKM120 60 mg daily, Vemurafenib 720 mg bid
~Dose Level 2: BKM120 80 mg daiy, Vemurafenib 720 mg bid
~Dose Level 3: BKM120 100 mg daiy, Vemurafenib 720 mg bid
~Dose Level 4: BKM120 100 mg daiy, Vemurafenib 960 mg bid
~Phase II is a single-stage, single arm prospective trial: patients will receive BKM120 and vemurafenib at the RP2D"
16184554|NCT01512238|Other|Pharmaceutical care|Information about medicine, sideeffect, adherence
16184555|NCT01512225|Drug|Domperidone maleate|domperidone maleate tablet 10 mg orally three times daily for 28 days
16184556|NCT01512225|Drug|Placebo Tablet|placebo tablet 10 mg orally three times daily for 14 days
16184557|NCT01512225|Drug|Domperidone maleate|domperidone maleate tablet 10 mg orally three times daily for 14 days
16184558|NCT01512212|Procedure|biopsy|fnab
16184559|NCT01512199|Drug|U3-1287|U3-1287: 18 mg/kg administered intravenously once every three weeks
16184560|NCT01512199|Drug|Trastuzumab|Trastuzumab: 6 mg/kg up to 8 mg/kg administered intravenously once every three weeks
16184561|NCT01512199|Drug|Paclitaxel|Paclitaxel: 175 mg/m^2 administered intravenously once every three weeks
16184562|NCT01512199|Drug|U3-1287|The maximum tolerated dose as determined in Phase 1b portion (between 9 mg/kg and 18 mg/kg) administered intravenously once every three weeks
16184563|NCT01512199|Drug|Trastuzumab|Trastuzumab: 6 mg/kg up to 8 mg/kg administered intravenously once every three weeks
16184564|NCT01512199|Drug|Paclitaxel|Paclitaxel: 175 mg/m^2 administered intravenously once every three weeks
16184565|NCT01512199|Drug|Placebo|Placebo: Dose corresponding to U3-1287 administered intravenously once every three weeks
16184566|NCT01512173|Drug|propranolol gel|Topical administration twice daily
16184567|NCT01512173|Drug|Placebo|Topical administration twice daily
16184568|NCT01512160|Drug|PF-04531083|2000 mg oral solution
16184569|NCT01512160|Other|Placebo|Placebo tablets for Ibuprofen
16184570|NCT01512160|Drug|PF-04531083|1000 mg oral solution
16184571|NCT01512160|Other|Placebo|Placebo tablets for Ibuprofen
16184572|NCT01512160|Drug|Ibuprofen|2 x 200 mg tablets
16184573|NCT01512160|Other|Placebo|Placebo solution for PF-04531083
16184574|NCT01512160|Other|Placebo|Placebo solution for PF-04531083
16184575|NCT01512160|Other|Placebo|Placebo tablets for Ibuprofen
16184576|NCT01512147|Other|Isoflurane, Propofol, Dexmedetomidine|"We will include following general anesthesia techniques:
~Fentanyl 1 - 2 mcg/kg/hr, Propofol 150 - 250 mcg/kg/min, Isoflurane 0.6% expiratory With this general anesthesia technique we will do our first SSEP/MEP measurements after 30 minutes.
~After 30 minutes we will stop isoflurane and will wash out the inhalational anesthetic with high flow air/oxygen and provide:
~Fentanyl 1 - 2 mcg/kg/hr, Propofol 150 - 250mcg/kg/min. This technique will be held for 30 minutes. SSEP/ MEP measurements will be done after 30 minutes.
~After the measurements dexmedetomidine will be added with a loading dose of 0.5 mcg/kg over 10 minutes and continuous infusion of 0.5 mcg/kg/hr for 30 minutes.
~Fentanyl 1 -2 mcg/kg/hr, Propofol 100 - 250mcg/kg/min, Dexmedetomidine 0.5 mcg/kg/hr."
16184577|NCT01512134|Device|Deep Brain Stimulation Device|Deep brain stimulation surgery
16184578|NCT01512108|Drug|liraglutide|0.9 mg/day liraglutide was injected once daily subcutaneously (s.c., under the skin).
16184579|NCT01512108|Drug|oral anti-diabetic drug|An additional oral anti-diabetic drug (OAD) with a different mechanism of action than the pre-trial OAD. The type and dosage of the additional OAD should be chosen by the investigator within the Japanese labelled dose.
16184580|NCT01512095|Drug|somatropin|A single dose administered subcutaneously (under the skin) on 2 separate dosing visits (treatment periods) separated by a wash-out period
16184581|NCT01512095|Drug|somatropin|A single dose administered subcutaneously (under the skin) on 2 separate dosing visits (treatment periods) separated by a wash-out period
16184582|NCT01512082|Device|Pulsed electromagnetic field devices|Every person received two active devices. The devices emitted 2-ms bursts of 27.12 MHz sinusoidal waves repeating at 2 bursts/s. Peak magnetic field intensity was 0.05 G which induced an average electric field of 10 mV in the tissue with an effect of 7.3 mW/cm3.
16184583|NCT01512082|Device|Pulsed electromagnetic field devices|Every persons received two sham pulsed electromagnetic field devices.
16184584|NCT01512069|Behavioral|Web-based Health Planner on diet and exercise|"URL is closed
~The program is 12-week program, provides tailored information on the exercise and diet based on the stage of motivational readiness of TTM. The program is designed to allow to plan a regular exercise of 12.5 MET per week and to recommend to eat number of portions from six food groups for balanced diet tailored to individual's BMI, ideal body weight, and calories needed per day. The program provide the feedback based on the achievement of goals of the behaviors."
16184585|NCT01512069|Behavioral|Non-tailored booklet on exercise and diet|The active control group is provided non-tailored booklet on exercise and diet, whose information is same as web-based program except stage-matching.
16184586|NCT01512056|Drug|AdimFlu-S|All enrolled participants will be divided into 3 groups: participants refused to receive vaccination, those receive either one (week 0) or one more booster vaccination (week 0 and week 3). Each dose of vaccine contains 15μg antigen of each virus strain suggested by WHO (A/California/7/2009 (H1N1);A/Perth/16/2009 (H3N2);B/Brisbane/60/2008).
16184587|NCT01512043|Behavioral|Breathing control|Practice of device guided breathing control twice a day for four weeks.
16184588|NCT01512017|Device|Crystalline cellulose simple occlusive dressing|A natural biological film of vegetable origin. It is classified as skin semi occlusive dressing, as a temporary skin substitute in case of skin lesions or loss.
16184589|NCT01512017|Device|Vaseline|External use
16184590|NCT01512004|Drug|Propiverine Hydrochloride|drug of oral capsule
16184591|NCT01512004|Drug|Tolterodine Extended-release Tablet|4mg/tablet; oral; once per day
16184592|NCT01511991|Drug|Sevoflurane dosage titration|comparisons of the effect of the 10 min-inhalation of each concentration of sevoflurane, 1.0 inspired vol%, 2.0 inspired vol% and 3.0 inspired vol% (T1, T2 and T3)
16184593|NCT01511978|Drug|Continuous 3,4-DAP|Subjects were maintained on their usual personal dose and schedule of 3,4-DAP base
16184594|NCT01511978|Drug|Taper 3,4-DAP to Placebo|Subjects were tapered over 3 days from their usual regimen of 3,4-DAP base to placebo with up to an additional 16 hours of placebo before resuming their usual pre-study regimen of 3,4-DAP base
16184595|NCT01511965|Other|autologous (cellular therapy)|The skin sample, the preparation and implementation of the epidermal cells, are conducted on one day. A review of selected lesions is performed and a photograph. Second, are performed successively in a single day the collection of thin skin, preparing the cell suspension, a desepidermisation laser Erbium: YAG lesions of vitiligo to be grafted, and applicated.
16184596|NCT01511952|Other|Music Intervention|Applied by randomization-live at bassinet in the AM or PM Gato Box, Ocean Disc or parent-selected lullabies
16184597|NCT01511952|Other|Music|Remo Ocean disc Gato box Music therapist's or Parent's preferred lullaby or 'Twinkle'
16184598|NCT01511939|Drug|Pennsaid|Administered 10 drops x 4 until 40 drops applied topically to index knee (and also non-index knee if osteoarthritis pain is present bilaterally) 4 times a day for a 4 week active treatment period.
16184599|NCT01511913|Other|Non-Interventional|Non-Interventional
16184600|NCT01511900|Drug|CAT 1004|Multiple dose oral administration once daily for 14 days of CAT 1004 at dose level 1-9 subjects will be treated with CAT-1004
16184601|NCT01511900|Drug|Placebo|Multiple dose oral administration of placebo daily for 14 days-3 subjects will be treated with placebo per cohort
16184602|NCT01511900|Drug|CAT 1004|Multiple dose oral administration once daily for 14 days of CAT 1004 at dose level 2 -9 subjects will be treated with CAT-1004
16184603|NCT01511900|Drug|CAT 1004|Multiple dose oral administration BID for 14 days of CAT 1004 at dose level 3-9 subjects will be treated with CAT-1004
16184604|NCT01511900|Drug|CAT 1004|Multiple dose oral administration BID for 14 days of CAT 1004 at dose level 4-9 subjects will be treated with CAT-1004
16184605|NCT01511900|Drug|CAT 1004|Multiple dose oral administration daily for 14 days of CAT 1004 at dose level TBD-9 subjects will be treated with CAT-1004
16184606|NCT01511887|Drug|Oral Ibuprofen|10mg/kg oral ibuprofen followed by two 5mg/kg in 12 hours intervals. If there was no improvement after first cycle of treatment this treatment was repeated.
16184607|NCT01511874|Drug|ELIGARD 22.5mg|a subcutaneous injection of ELIGARD 22.5mg at 0 and 12weeks
16184608|NCT01511848|Drug|DFP (ferriprox) and deferasirox (ICL 670)|"Drug: Ferriprox It will be given orally in the morning Other Name: DFP Initial dose 25/mg/kg 3 times/d (better tolerated if started and then built up over 4 weeks).
~Dose may be increased up to 100mg/kg/day guided by serum ferritin. Agranulocytosis risk 1-2%. Monitor TLC and granulocytic count / 2weeks. Patients need to be continually educated about this risk, know that they must stop DFP if they have a fever or infection.
~Drug: Deferasirox will be orally administered at a dose of 20 mg/kg once daily at evening for 5 days.
~Other Name: ICL670"
16184609|NCT01511848|Drug|DFP, DFO|"Drug: Deferoxamine It will be administered subcutaneously over 8 hours for 5 days at a dose of 40 mg/kg.
~Other Name: Desferal, DFO Drug: DFP DFP: will be orally administered at a dose of 75mg/kg orally in 3 divided doses for 7 days"
16184610|NCT01511835|Dietary Supplement|inositol + folic acid|2000 mg of inositol+200mcg of folic acid; 2 per diem
16184611|NCT01511835|Dietary Supplement|inositol + folic acid|600 mg of inositol + 200mcg of folic acid; 2 cp per diem
16184612|NCT01511835|Drug|Folic Acid|Folic Acid 400mcg; 1 cp/die
16184613|NCT01511822|Drug|Drospirenone Ethinyl estradiol|Drospirenone 3mg/die Ethinyl estradiol 30 mg/die (21 days/month for 6 months)
16184614|NCT01511822|Drug|Drospirenone Ethinyl estradiol Myo-inositol|Drospirenone 3mg/die Ethinyl estradiol 30 mg/die (21 days/months for 6 months) + Myo-inositol 6g /die for 6 months
16184615|NCT01511822|Drug|placebo|
16184616|NCT01511809|Drug|Atazanavir/ritonavir monotherapy|Monotherapy Simplification Strategy with Atazanavir/ritonavir 300/100 mg once daily for 96 weeks.
16184617|NCT01511796|Other|upper limb rehabiliation|3 months upper rehabilation (twice a week) and then 3 more months upper limb rehabitation ( twice a week)
16184618|NCT01511783|Drug|E2609|E2609 to be administered for 14 days, concurrently with placebo controls. Doses will be 25, 50, and 200 mg once daily by the oral route, each dose administered to a separate cohort (group) of subjects. After each dose has been administered to all subjects in a given cohort, safety and tolerability findings will be evaluated and a decision made by the sponsor and investigators as to whether or not to proceed to the next higher dose.
16184619|NCT01511783|Drug|Placebo|E2609 to be administered for 14 days, concurrently with placebo controls. Doses will be 25, 50, and 200 mg once daily by the oral route, each dose administered to a separate cohort (group) of subjects. After each dose has been administered to all subjects in a given cohort, safety and tolerability findings will be evaluated and a decision made by the sponsor and investigators as to whether or not to proceed to the next higher dose.
16184620|NCT01511770|Drug|Fluconazole|Fluconazole Tablets, 200 mg
16184621|NCT01511770|Drug|Fluconazole|Fluconazole 200 mg tablets
16184622|NCT01511757|Drug|Fluconazole|Fluconazole Tablets, 200 mg
16184623|NCT01511757|Drug|Fluconazole|fluconazole 200 mg
16184624|NCT01511744|Biological|Inactivated influenza split vaccine|3000 participants (750 of above 60,750 of age 19-60, 750 of age 13-18 and 750 of age 3-12) to receive influenza split vaccine of 15 μg HA; one dose regime
16184625|NCT01511731|Drug|Famotidine|Famotidine Tablets 40 mg
16184626|NCT01511731|Drug|Pepcid|40mg tablets
16184627|NCT01511718|Drug|Ondansetron Hydrochloride|Ondansetron Hydrochloride Tablets 8 mg
16184628|NCT01511718|Drug|Ondansetron Hydrochloride|Zofran Tablets 8 mg
16184629|NCT01511705|Drug|Ondansetron Hydrochloride|Ondansetron Hydrochloride Tablets 8 mg
16184630|NCT01511705|Drug|Ondansetron Hydrochloride|Zofran Tablets 8 mg
16184631|NCT01511692|Drug|liraglutide|1.8 mg/day injected subcutaneously for 4 weeks
16184632|NCT01511692|Drug|placebo|Liraglutide placebo, injected subcutaneously for 4 weeks
16184633|NCT01511692|Drug|placebo|Glimepiride placebo, dose individually adjusted, administered orally for 4 weeks
16184634|NCT01511692|Drug|glimepiride|Dose individually adjusted, administered orally for 4 weeks
16184635|NCT01511666|Device|Prehospital mechanical compressions, intraarrest cooling and in hospital ECLS|ECLS states for extracorporeal life support.
16184636|NCT01511666|Other|Standard care|Standard care as per recent guidelines will be provided.
16184637|NCT01511640|Drug|Pregabalin|pregabalin 2x daily for duration of study
16184639|NCT01511627|Drug|General Anesthesia + Spinal anesthesia combined|"All patients will receive a preoperative multimodal analgesic regime:
~Tylenol® 975mg per os
~Naproxen® 500 mg per os
~Patients will receive a spinal anesthetic with:
~Bupivacaine 0.5% 10 mg
~Fentanyl 10ug
~Epidural Morphine 150ug
~After the spinal, a general anesthetic will be induced using:
~Midazolam 1 - 2 mg intravenously
~Fentanyl 1 - 2 ug/kg intravenously
~Propofol 1-3 mg/kg intravenously
~Rocuronium 0.3 - 0.9mg/kg intravenously
~followed by endotracheal intubation. Maintenance of anesthesia with sevoflurane, oxygen and air.
~Intraoperative Morphine 0 - 0.3mg/kg or Fentanyl 0 - 7.5ug/kg to maintain MAP and heart rate within 20% of baseline.
~Phenylephrine and Ephedrine can be used to support blood pressure and heart rate within 20% of baseline.
~Dexamethasone 4mg and Ondansetron 4mg intravenously
~Neostigmine 3mg and Glycopyrrolate 0.6mg intravenously Patients will receive a Morphine PCA to be initiated in the Post Anesthetic Care Unit (PACU)."
16184640|NCT01511627|Drug|General Anesthesia (control group)|"All patients will receive a preoperative multimodal analgesic regime:
~Tylenol® 975mg per os
~Naproxen® 500 mg per os
~Group I (General anesthetic) patients will receive a general anesthetic :
~Midazolam 1 - 2 mg intravenously
~Fentanyl 1 - 2 ug/kg intravenously
~Propofol 1-3 mg/kg intravenously
~Rocuronium 0.3 - 0.9mg/kg intravenously
~followed by endotracheal intubation. Maintenance of anesthesia with sevoflurane, oxygen and air.
~Intraoperative Morphine 0 - 0.3mg/kg or Fentanyl 0 - 7.5ug/kg. to maintain MAP and heart rate within 20% of baseline.
~Phenylephrine and Ephedrine can be used to support blood pressure and heart rate within 20% of baseline.
~Dexamethasone 4mg and Ondansetron 4mg intravenously
~Neostigmine 3mg and Glycopyrrolate 0.6mg intravenously
~Patients will receive a Morphine PCA as per protocol that will be initiated in the Post Anesthetic Care Unit (PACU)."
16184641|NCT01511614|Device|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation (tDCS), a type of Non-invasive Brain Stimulation (NIBS), has the potential to modify neuronal circuits by application of a subthreshold conductive current through the scalp. Two potential targets for tDCS as a smoking cessation aid are the dorsolateral prefrontal cortex (dlPFC), a node of the ECN, and the ventromedial prefrontal cortex (vmPFC), a node of the DMN. tDCS can potentially strengthen the control of the ECN through excitatory stimulation of the dlPFC, and weaken the influence of the DMN by inhibitory stimulation of the vmPFC. The tDCS model we will use is the neuroConn DCStimulator MR (neuroCare Group GmbH, Munchen, Germany).
16184642|NCT01511614|Device|Sham|Sham Comparator
16184643|NCT01511575|Genetic|RNA analysis|
16184644|NCT01511575|Genetic|reverse transcriptase-polymerase chain reaction|
16184645|NCT01511575|Other|laboratory biomarker analysis|
16184646|NCT01511562|Drug|carmustine|Given IV
16184647|NCT01511562|Drug|cytarabine|Given IV
16184648|NCT01511562|Drug|etoposide|Given IV
16184649|NCT01511562|Drug|thiotepa|Given IV
16184650|NCT01511562|Procedure|stem cell transplant|
16184651|NCT01511562|Drug|G-CSF|
16184652|NCT01511549|Drug|placebo|"Pharmaceutical form:injection
~Route of administration: intra-articular"
16184653|NCT01511549|Drug|SAR113945|"Pharmaceutical form:injection
~Route of administration: intra-articular"
16184654|NCT01511536|Drug|Cabazitaxel XRP6258|Pharmaceutical form:solution Route of administration: injection
16184655|NCT01511536|Drug|Abiraterone acetate|Pharmaceutical form:tablets Route of administration: oral
16184656|NCT01511536|Drug|Prednisone 5 mg|Route of administration: oral
16184657|NCT01511523|Dietary Supplement|RGMA001|3 capsules administered BID once a day.
16184658|NCT01511523|Dietary Supplement|Sugar Pill|Placebo
16184659|NCT01511510|Drug|PF-04958242|PF-04958242 0.05 mg oral solution Q24 hours for 14 days
16184660|NCT01511510|Drug|PF-04958242|PF-04958242 0.10 mg oral solution Q24 hours for 14 days
16184661|NCT01511510|Drug|PF-04958242|PF-04958242 0.15 mg oral solution Q24 hours for 14 days
16184662|NCT01511510|Drug|PF-04958242|PF-04958242 0.25 mg oral solution Q24 hours for 14 days
16184663|NCT01511510|Drug|Placebo|Placebo oral solution Q24 hours for 14 days
16184664|NCT01511497|Biological|PF-04427429|Intravenous, single dose given over 1 hour with experimental dose. Subjects can receive one of four potential doses - 300, 1000, 1500 or 2000 mg.
16184665|NCT01511497|Other|Normal saline|Intravenous, normal saline
16184666|NCT01511484|Behavioral|Information-only|"Selected pages from the British National Health Service (NHS) information booklets [5 A Day, Just Eat More (fruit & veg); pages i, ii, 12-15, 20 & 21] and [5 A Day, Just Eat More (fruit & veg): What's it all about?; pages i-ii)] were provided to all participants on completion of baseline questionnaires. The pages provided information on recommended portion sizes, meal planning, health benefits and answered frequently asked diet-related questions"
16184667|NCT01511484|Behavioral|Generic appearance intervention|"Participants in the generic appearance intervention group received images to illustrate the impact of fruit and vegetable consumption on skin appearance. Participants in this group were presented with gender congruent stimuli, constructed by averaging the facial shape and colour of four male/female faces.
~Participants viewed the gender-congruent set of the resulting stimuli in two forms. Firstly, after completion of baseline questionnaires, images were displayed on a computer monitor. Participants were instructed to select what they perceived as the healthiest face colour, which was recorded by the computer program over two trials.
~Participants in this group also received a take-home photo quality leaflet to further illustrate the effect of fruit and vegetable consumption on skin colour."
16184668|NCT01511484|Behavioral|Personalised appearance intervention|Participants in this group received stimuli manipulated in identical ways to that received by the generic appearance-intervention group, except the illustrations were performed upon images of the participant's own face.
16184669|NCT01511471|Drug|Ticagrelor|Ticagrelor 90mg twice a day for 15 days
16184670|NCT01511445|Device|Anterior cervical discectomy and fusion (ACDF) with PEEK Cage|Anterior cervical discectomy and fusion with the use of a PEEK plastic interbody spacer
16184671|NCT01511445|Device|Anterior cervical discectomy and fusion (ACDF) with a Valeo CSC Cage|Anterior cervical discectomy and fusion with a Valeo ceramic cage interbody spacer.
16184672|NCT01511432|Drug|telaprevir formulation A|A single 1125-mg dose administered orally
16184673|NCT01511432|Drug|telaprevir Formulation B|A single 1125-mg dose administered orally
16184674|NCT01511432|Drug|telaprevir Formulation C|A single 1125-mg dose administered orally
16184675|NCT01511432|Drug|telaprevir Formulation D|A single 1125-mg dose administered orally
16184676|NCT01511419|Biological|LAIV H7N3|2 doses of vaccine
16184678|NCT01511406|Behavioral|cognitive behavioral therapy|Patients allocated to the treatment arm will receive up to 26 sessions of cognitive behavioral therapy
16184679|NCT01511393|Other|No treatment given|None. Non-interventional study.
16184680|NCT01511380|Behavioral|Risk Reduction Therapy for Adolescents|This project integrates CM and a family systems intervention for sexual risk with evidence-based family engagement strategies, and tests this intervention in a juvenile drug court setting. Due to the individualized nature of the proposed intervention, the specific course of treatment will vary by youth and family. Based on our experience with clinic-based treatment models it is anticipated that most families will remain in active treatment for 4-6 months and that, during this time, they will attend approximately 1-2 sessions per week, for 1-2 hours per session.
16184681|NCT01511380|Behavioral|Usual services|In addition to the standard juvenile drug court requirements, youth randomly assigned to the usual services condition are also ordered to receive treatment services from the local state or privately-funded alcohol and drug treatment provider agencies. The service delivery model for agencies typically includes intensive outpatient, traditional outpatient, and home-based services, depending upon assessment of youth and family needs. Groups focus on risk reduction, peer influence, conflict resolution, and anger management. Additionally, youth might receive treatment pertaining to drug selling behavior, individual sessions and/or family group therapy. The theoretical orientations of the provider agencies are cognitive-behavioral and systems theory. Interventions are not usually manual driven, and selection of material is typically left to the therapists' discretion.
16184682|NCT01511367|Drug|Flutiform|50/5ug (fluticasone/formoterol) 2 puffs twice daily
16184683|NCT01511367|Drug|Seretide|50/25 ug (fluticasone/salmeterol) 2 puffs twice daily
16184684|NCT01511367|Drug|Flixotide|50ug 2 puffs twice daily
16184685|NCT01511341|Behavioral|Telenursing|The nurse-led intervention will consist of providing a monthly telephone call by a qualified and experienced nurse specialist in paediatric rheumatology and TN to ensure follow-up of the children and their family. The intervention will focus on providing affective support, health information, and aid to making decision.
16184686|NCT01511328|Other|HPV testing|Testing for Human Papilloma Virus
16184687|NCT01511315|Drug|Ustekinumab|Biologic agent: sub-cutaneous injection at Weeks 0, 4, and then every 12 weeks thereafter.
16184688|NCT01511302|Drug|RNS60|RNS60, 2ml, nebulized twice daily.
16184689|NCT01511302|Drug|Normal Saline|Normal Saline placebo, 2 ml, nebulized twice daily.
16184690|NCT01511302|Drug|Budesonide|Budesonide, in either 0.25 mg or 0.5 mg per 2 ml concentration in liquid suspension, nebulized once per day in combination with RNS60 or NS.
16184691|NCT01511289|Drug|Imatinib|400mg/Tab, QD
16184692|NCT01511289|Drug|Radotinib|100mg or 200mg/Capsule, 300mg or 400mg BID
16184693|NCT01511276|Behavioral|Diet|Energy restricted diet, according the national guidelines for healthy nutrition, creating a mean energy deficit of 500 kCal/day.
16184694|NCT01511276|Behavioral|Mainly exercise induced weight loss|"Exercise programme of 2 hours per week fitness containing endurance and resistance training. And 2 hours of Nordic Walking. Equivalent to an energy expenditure of 350 kCal/day.
~Next to the exercise programme participants will follow an energy restricted diet according to the national guidelines of healthy nutrition creating an extra energy deficit of 250 kCal/day."
16184695|NCT01511263|Drug|Diuretics (plus antiarrhythmic drugs, i.e. amiodarone, in case of complex ventricular arrhithmias)|Antiarrhythmic drugs (i.e. amiodarone), angiotensins which transform inhibitor enzymes, and/or beta-blockers if tolerated.
16184696|NCT01511263|Drug|Diuretics (plus antiarrhythmic drugs, i.e. amiodarone, in case of complex ventricular arrhythmias) plus EGCG|"Antiarrhythmic drugs (i.e. amiodarone), angiotensins which transform inhibitor enzymes, and/or beta-blockers if tolerated.
~EGCG, 675 mg/day, oral, for one year."
16184697|NCT01511250|Biological|TDV|TDV 0.5 mL, injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose). TDV comprised of 4 recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4 containing 2*10^4 PFU, 5*10^4 PFU, 1*10^5 PFU, and 3*10^5 PFU respectively, total virus per dose: 4.7*10^5 PFU.
16184698|NCT01511250|Biological|Placebo|TDV placebo-matching 0.5 mL injection, subcutaneously, once on Day 0 (first dose) and Day 90 (second dose).
16184700|NCT01511211|Drug|Dexamethasone|2 cc of 4 mg/cc dexamethasone will be added to 38 cc of 0.5% ropivacaine solution. Of this combination, 15 cc will be used for a femoral nerve block, 20 cc for the popliteal nerve block, and 5 cc for the obturator nerve block. In addition, 2 cc of normal saline will be added to the patient's IV to maintain blinding.
16184701|NCT01511211|Drug|Ropivacaine|2 cc of normal saline will be added to 38 cc of 0.5% ropivacaine solution. Of this combination, 15 cc will be used for the femoral nerve block, 20 cc for the popliteal nerve block, and 5 cc for the obturator nerve block. In addition, 2 cc of 4 mg/cc dexamethasone will be added to the patient's IV.
16184702|NCT01511198|Drug|liraglutide|Injected subcutaneously once daily
16184703|NCT01511198|Drug|metformin|1000 mg twice daily, administered orally
16184704|NCT01511185|Drug|liraglutide|A single dose of 7.5 mcg/kg administered subcutaneously in random order
16184705|NCT01511185|Drug|placebo|A single dose administered subcutaneously in random order
16184706|NCT01511172|Drug|liraglutide|Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously
16184707|NCT01511172|Drug|metformin|1000 mg daily, administered orally
16184708|NCT01511172|Drug|placebo|Metformin placebo administered orally. 1000 mg daily
16184709|NCT01511172|Drug|placebo|NNC 90-1170 placebo. Individually adjusted dose, maximum 2.0 mg. Injected subcutaneously
16184710|NCT01511172|Drug|glimepiride|Individually adjusted dose, administered orally
16184711|NCT01511159|Drug|liraglutide|Single dose of 6 mcg/kg by inhalation. Progression to open-label trial part will be based on safety data
16184712|NCT01511159|Drug|placebo|Single dose by inhalation. Progression to open-label trial part will be based on safety data
16184713|NCT01511159|Drug|liraglutide|Single dose of 12 mcg/kg by inhalation. Subjects receive treatment in random order
16184714|NCT01511159|Drug|liraglutide|Single dose 6 mcg/kg injected subcutaneously. Subjects receive treatment in random order
16184715|NCT01511159|Drug|insulin human|Single dose 0.4 IU/kg by inhalation. Subjects receive treatment in random order
16184716|NCT01511159|Drug|insulin human|Single dose 0.08 IU/kg injected subcutaneously. Subjects receive treatment in random order
16184717|NCT01511159|Drug|liraglutide|24 mcg/kg by inhalation. Progression to dose level will be based on safety evaluation
16184718|NCT01511146|Drug|Oxaliplatin|oxaliplatin 85 mg/m2 in 10 minutes
16184719|NCT01511146|Drug|Mitomycin + Gemcitabine|Mitomycin 5 mg/m2 Gemcitabine 1000 mg/m2
16184720|NCT01511133|Procedure|Stool sample|Stool samples collected at pre-determined time points in previous studies will be analysed to detect the presence of PCV-1 DNA and pattern of detection.
16184721|NCT01511133|Procedure|Serum sample|Serum samples collected at pre and post vaccination time points in previous studies will be assessed for Anti-PCV-1 antibody.
16184722|NCT01511120|Drug|Tetraspan|
16184723|NCT01511120|Drug|acetated Ringer's solution|
16184724|NCT01511107|Drug|Amoxicillin-Clavulanate, 10 days|Amoxicillin-clavulanate (90/6.4mg/kg/day in 2 divided doses) Days 1-10
16184725|NCT01511107|Drug|Amoxicillin-Clavulanate, 5 days|"Amoxicillin-clavulanate (90/6.4mg/kg/day in 2 divided doses) Days 1-5
~Plus
~Placebo Days 6-10"
16184726|NCT01511094|Procedure|Goniocurettage|Ab interno surgery consisting on scraped away the trabecular tissue from the angle (goniocurettage) removing segments of pathologically altered trabecular meshwork from the scleral sulcus
16184727|NCT01511081|Radiation|SBRT (stereotactic body radiotherapy)|50 Gy (RBE) in 4 daily treatments of stereotactic body radiotherapy (SBRT). Each treatment taking about 30-45 minutes per day.
16184728|NCT01511081|Radiation|SBPT (stereotactic body proton therapy)|50 Gy (RBE) in 4 daily treatments of stereotactic body proton therapy (SBPT). Each treatment taking about 30-45 minutes per day.
16184729|NCT01511068|Drug|Leukine|Participants will receive inhaled rhGM-CSF (Sargramostim, Leukine) at the dose of 250 mcg one time per week for 12 weeks. Following an interim safety evaluation, participants may be entered into a second 12 week treatment period where participants will receive either 250 mcg or 500 mcg once weekly. At the end of any treatment period, participants will be followed for 12 additional weeks in the absence of inhaled rhGM-CSF to evaluate safety and efficacy.
16184730|NCT01511055|Drug|EC-17|One-time dose of Folate-FITC (EC-17), 0.1mg/kg IV 2-3 hours prior to surgery.
16184731|NCT01511042|Drug|Para-aminohippuric Acid|"Aminohippurate sodium is an agent to measure effective renal plasma flow (ERPF). It is the sodium salt of para-aminohippuric acid, commonly abbreviated PAH."
16184732|NCT01511042|Drug|Angiotensin II|Angiotensin II (Ang II) is a naturally occurring hormone whose primary purpose is to regulate the body's internal volume. It accomplishes this task by influencing the function of a variety of organs and tissues. It increases aldosterone secretion from the adrenal gland. It causes blood vessels to contract, particularly renal blood vessels, and it modifies the way the heart works.
16184733|NCT01511042|Drug|Norepinephrine|A hormone that is normally present in your body, which regulates your blood pressure.
16184734|NCT01511029|Drug|Dexpramipexole|300 mg - Oral Tablets
16184735|NCT01511029|Drug|Dexpramipexole|600 mg Oral Tablets
16184736|NCT01511029|Drug|Dexpramipexole Placebo|Placebo - Oral Tablet
16184737|NCT01511029|Drug|Moxifloxacin|400 mg - Oral Tablet
16184738|NCT01511016|Drug|"Human recombinant leptin (metreleptin)"|Metreleptin was administered at a dose of 0.02 mg / kg body weight for two months, followed by a dose of 0.04 mg / kg for two more months.
16184739|NCT01511016|Drug|Placebo|Placebo was administered at a dose of 0.02 mg / kg body weight daily by subcutaneous injection for two months, followed by 0.04 mg / kg for two more months.
16184740|NCT01511003|Drug|Tacrolimus|oral
16184741|NCT01510990|Drug|Gefitinib|gefitinib 250mg/day daily
16184742|NCT01510977|Drug|polyethylene glycol, Bisacodyl|After failure of first colonoscopy, bowel preparation with polyethylene glycol and bisacodyl one week after
16184743|NCT01510977|Drug|polyethylene glycol|Immediately after first colonoscopy failure, polyethylene glycol 2L addition
16184744|NCT01510964|Behavioral|prompt-sheet|"Prompt sheet is a form on which to write the reply to the following request: Please indicate the arguments which you want to discuss today with your oncologist and a written list of possible questions the patient (companion) would like to ask to the oncology."
16184745|NCT01510964|Behavioral|control group|"Patients and companions of the control group receive a form on which to write their reply to the following request: Please indicate the arguments which you want to discuss today with your oncologist"
16184746|NCT01510951|Drug|AMG 811 or Placebo|Single dose subcutaneous administration of AMG 811 or placebo to adult subjects with psoriasis.
16184747|NCT01510938|Dietary Supplement|L. acidophilus DDS-1, B. lactis UABLA-12|1 g of probiotic will be reconstituted in 25-50 ml tepid water, juice or age specific baby food and immediately fed once a day (5 billion CFU/daily) for 2-weeks trial period or to the end of acute respiratory infection depending on whatever is longer.
16184748|NCT01510938|Dietary Supplement|Placebo|1 g in 25-50 ml of tepid water or juice fed once a day for 2-weeks trial period or to the end of acute respiratory infection depending on whatever is longer.
16184749|NCT01510912|Drug|Diclofenac|35 mg bid or tid Capsules
16184750|NCT01510899|Drug|RO4917838|Single dose of RO4917838
16184751|NCT01510899|Drug|RO4917838|Single dose of RO4917838
16184752|NCT01510873|Other|HRQOL evaluation|"Patients will be asked to complete a Questionnaire (i.e. HRQOL Survey Packet) that will cover a number of issues. These will include socio-demographic aspects, HRQOL information, symptom burden, clinical decision-making, social support and psychological wellbeing. Most of these information will be collected through well known psychometrically sound questionnaires. The copyright for using standardized questionnaires will be obtained, from the appropriate copyright holders, for the purpose of this research.
~The Questionnaire properly formatted will be distributed to all participating Centers prior to study start."
16184753|NCT01510860|Drug|UDCA (Ursodeoxycholic acid)|250 mg
16184754|NCT01510860|Drug|UDCA (Ursodeoxycholic acid)|500 mg
16184755|NCT01510847|Drug|Andriol Testocaps|Oral, 40mg, Twice a day, 30days
16184756|NCT01510834|Behavioral|Multibehavioral, Computerized Tailored Intervention STR2IVE|All participants were provided with the same multibehavioral CTI system and chose two or three behavior programs to complete (smoking cessation, stress management, and/or depression prevention)monthly. They were asked to complete an assessments at baseline, 30-days, and 90-days. They were allowed to access the system workbook anytime but they must wait a minimum of 25 days between assessments and programs at time points 1 and 2, and 55 days between time points 2 and 3.
16184757|NCT01510821|Other|Use of Maquet Vasoshield Pressure-limiting syringe on SVG|Use of Maquet Vasoshield Pressure-limiting syringe on SVG
16184758|NCT01510821|Other|Use of non-regulated syringe on SVG|Use of non-regulated syringe on SVG
16184759|NCT01510808|Procedure|orthodontic treatment|Patients with Aggressive Periodontitis which are in the maintenance phase, had been treated for malocclusion.
16184760|NCT01510795|Drug|spironolactone|Spironolactone initiated at 3 months posttransplant at 25 mg qd and up-titrated to 50 mg qd after 14 days. Spironolactone therapy will be maintained for 9 months.
16184761|NCT01510782|Drug|Placebo to BI 655064|intravenous infusion of escalating doses
16184762|NCT01510782|Drug|Placebo to BI 655064|subcutaneous injection of escalating doses
16184763|NCT01510782|Drug|BI 655064|intravenous infusion of escalating doses
16184764|NCT01510782|Drug|BI 655064|subcutaneous injection of escalating doses
16184765|NCT01510769|Drug|Lesinurad|Tablets, 400 mg once daily (QD)
16184766|NCT01510769|Drug|Lesinurad|Tablets, 200 mg QD
16184767|NCT01510769|Drug|Placebo|Tablets, Placebo QD
16184768|NCT01510769|Drug|Febuxostat|80 mg
16184769|NCT01510756|Drug|Sorafenib|Sorafenib 400mg orally twice daily will be administered for three cycles (1 cycle = 28 days). Subjects without significant toxicity or progressive disease may elect to continue treatment for a total of twelve cycles.
16184770|NCT01510743|Procedure|Catheterization of subclavian vein|Catheterization of subclavian vein
16184771|NCT01510743|Procedure|Catheterization of internal jugular vein|Catheterization of internal jugular vein
16184772|NCT01510730|Drug|eradication treatment of Helicobacter pylori infection|Eradication group receive Omeprazole sodium 20mg, amoxicillin 1g, clarithromycin 500mg orally at the same time twice daily for 7 days.
16184773|NCT01510717|Device|AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0]|Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient
16184774|NCT01510717|Device|AcrySof® IQ Monofocal IOL Model SN60WF|Monofocal IOL implanted for long-term use over the lifetime of the cataract patient
16184775|NCT01510704|Drug|APD421|IV
16184776|NCT01510704|Drug|Placebo|IV
16184777|NCT01510678|Behavioral|Increase Fruits and Vegetables|Children will be encouraged to consume 1 cup/day and 1.5 cups/day of whole fruit, and 1.5 cups/day and 2 cups/day of vegetables for children aged 6 to 8 years and 9 to 12 years, respectively. Children will gradually work towards these goals. Parents will also work towards F&V goals, with 2 cups/day of whole fruit and 2.5 cups/day of vegetables. Both parent and child will self-monitor these behaviors. As one barrier to consuming F&Vs is perceived cost of these foods, information regarding lower-cost options for F&Vs will be included in the manual.
16184778|NCT01510678|Behavioral|Decrease Snack Foods|This condition will reduce intake of SFs (i.e., candy, cookies, cakes, ice cream, chips, nuts) to < 3 servings/week (for children aged 6 to 12 years, the solid fats and added sugar energy limit is 840 kcals/week and the DECREASE goal will help with meeting this limit). Children and parents will gradually work towards meeting these goals and self-monitor these behaviors.
16184779|NCT01510678|Behavioral|Increase Fruits and Vegetables and Decrease Snack Foods|Will combine the goals of the increase and decrease conditions.
16184780|NCT01510665|Dietary Supplement|Magnesium citrate|Magnesium citrate tablets 950 mg, two pills once daily (Total daily dose of 300 mg elemental magnesium)
16184781|NCT01510665|Dietary Supplement|Placebo|Identical appearing placebo with inactive ingredients, two pills once daily.
16184782|NCT01510665|Behavioral|Dietary modification|Nutritionist counseling session and advice on following a magnesium rich diet
16184783|NCT01510652|Procedure|BiP Group|Implantation of standard Left Ventricular (LV) lead
16184784|NCT01510652|Device|Quad Group|Implantation of quadripolar Left ventricular (LV) lead Quartet
16184785|NCT01510639|Biological|Platelet Rich Plasma|The application of autologous thrombocyte concentrate (PRP). This is a concentrate with a high amount of thrombocytes (containing growth factors), obtained by centrifuging the patient's own blood. The concentrate is applied into the subacromial space after closure.
16184786|NCT01510626|Dietary Supplement|Food proteins|Food proteins
16184787|NCT01510626|Drug|Omalizumab|Drug
16184788|NCT01510613|Drug|Pomalidomide and Dexamethasone|Pomalidomide: 2-4mg/day, every day in cycles of 28 days until progression or unacceptable toxicity Dexamethasone: 20-40mg/week, on days 1, 8, 15, 22 in cycles of 28 days until progression or unacceptable toxicity
16184789|NCT01510600|Genetic|DNA analysis|
16184790|NCT01510600|Genetic|polymerase chain reaction|
16184791|NCT01510600|Other|laboratory biomarker analysis|
16184792|NCT01510600|Other|medical chart review|
16184793|NCT01510587|Behavioral|4-Health Educational curriculum|During the intervention, parents meet about every 3 weeks (90 min/session) in small groups with facilitators. During meetings classroom activities aim to integrate 3 areas: 1) parents' knowledge about healthy diets, physical activity and improved body image; 2) parents' understanding, skills and potential roles as positive change-agents (i.e., parenting and behavior management); and 3) parents' learning and practicing cognitive-behavioral exercises that encourage specific skills within the family/home setting. Between monthly meetings, participants explore a suggested online websites or facilitator-assigned questions and provide feedback. The majority of outside time/assignments for parents is spent doing take-home activities with their preteen child and family.
16184794|NCT01510587|Behavioral|Healthy Living Information|During the Healthy Living Information intervention, participants receive packets delivered to their homes by mail at intervals similar to the meeting intervals for the educational curriculum intervention. (10 total packets.) Approximately every three weeks between late September 2011 and April 2012, corresponding approximately to the meeting times for the 4-Health Educational Program, participants in the Healthy Living Information control group receive mailed packets of information.
16184795|NCT01510574|Drug|Misoprostol|3 x 200mcg tablets of oral misoprostol
16184797|NCT01510561|Drug|90Y-hPAM4|90Y-hPAM4 will be administered weekly for 3 weeks in conjunction with gemcitabine which will be administered weekly x 4.
16184798|NCT01510561|Drug|90Y-hPAM4|
16184799|NCT01510561|Drug|90Y-hPAM4 + gemcitabine|
16184800|NCT01510548|Biological|Adalimumab injections for acute disc prolapse patients|see the study protocol. Three arms, which two of them included active medication and one will be placebo( NaCl solution) in controlled double blind setting.
16184801|NCT01510535|Drug|Placebo|First 2 weeks Placebo(2ml) once weekly in experimental group
16184802|NCT01510535|Drug|Hyruan Plus|Hyruan Plus Inj. (2ml)once weekly for 3 weeks in control group
16184803|NCT01510535|Drug|LBSA0103|at third week LBSA0103(60mg) once in experimental group
16184804|NCT01510522|Drug|Glucophage|Glucophage Powder for oral solution in sachets (metformin hydrochloride in 850mg strengths) Dosing schedule: > 1.700mg/day for 6 month
16184805|NCT01510522|Drug|Glucophage|"Glucophage tablets (metformin hydrochloride in 850mg strengths)
~Dosing schedule: > 1.700mg/day for 6 month"
16184806|NCT01510509|Device|Titanium bare metal stent (Titan2®)|Titan2®, Hexacath, Paris, France
16184807|NCT01510509|Device|Everolimus Drug Eluting Stent (Xience-V®)|Xience-V®, Abbott Vascular, Santa Clara, California, USA
16184808|NCT01510496|Procedure|Inguinal herniorraphy.|Inguinal herniorraphy (non laparoscopic).
16184809|NCT01510496|Procedure|Hysterectomy.|Hysterectomy: Vaginal and abdominal.
16184810|NCT01510496|Procedure|Thoracotomy .|Thoracotomy (non laparoscopic).
16184811|NCT01510483|Behavioral|Obesity Prevention|Those in the experimental, obesity prevention, condition will be exposed to the office-wide intervention for diet and activity. The intervention will consist of training of orthodontists and office staff to provide appropriate social prompts, reinforcement and counseling, and modification of the offices to provide supportive physical and social resources for their patients and parents.
16184812|NCT01510483|Behavioral|Tobacco Prevention|Those in the control, tobacco prevention, condition will be exposed to the office-wide intervention for avoidance of tobacco and second hand smoke. The intervention will consist of training of orthodontists and office staff to provide appropriate social prompts, reinforcement and counseling, and modification of the offices to provide supportive physical and social resources for their patients and parents.
16184813|NCT01510457|Drug|Milnacipran|Total target dose of 200 mg/day. Subjects will titrate-up according to the following schedule: 25 mg/d (2 pills, 2 days), 50mg mg/d (4 pills, 2 days), 100mg/d (2 pills, 3 days), 150 mg/d (3 pills, 4 days), and steady state is reached once the study participant ingests 200 mg/d(4 pills). The steady state is maintained for 44 days (approx. 6 weeks). If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 100 mg/day at the discretion of the PI. Subjects unable to tolerate 100 mg/day will be discontinued from the study. A 2-week down-titration will be used.
16184814|NCT01510457|Drug|Placebo|Subjects will receive identical placebo pills and dosing schedule as that of participants receiving active study medication.
16184815|NCT01510431|Drug|PROCHYMAL (remestemcel-L)|intravenous administration of 200 million cells on days 0, 3, 7, and 14, and then, at investigator discretion, periodically thereafter
16184816|NCT01510405|Other|Tissue Collection|Tissue sample collection
16184817|NCT01510392|Device|OCT imaging, the FDA Cleared iVue|The OCT system scans a beam of light across the eye to take a picture. OCT imaging does not touch the eye. This is a test that is performed using an FDA approved system, and is regularly used to take pictures of the back of the eye.
16184818|NCT01510379|Device|Reletex|Neurostimulation device for prevention/treatment of post-operative nausea and vomiting, Reletex arm.
16184819|NCT01510379|Drug|IV ondansetron 4 mg q 6 hours for a total of 4 doses|
16184820|NCT01510379|Drug|IV promethazine 25 mg q 6 hours prn|
16184821|NCT01510379|Drug|Elixir promethazine 25 mg q 6 hours prn after discharge|
16184822|NCT01510366|Biological|Inactivated Poliomyelitis Vaccine (Sabin strains)|Inactivated Poliomyelitis Vaccine (Sabin strains) 3 x 0.5ml intramuscular injections, one month apart.
16184823|NCT01510366|Biological|Inactivated Poliomyelitis Vaccine (Salk strains)|Inactivated Poliomyelitis Vaccine (Salk strains)3 x 0.5ml intramuscular injections, one month apart.
16184824|NCT01510353|Device|Radiation monitoring device|Radiation monitoring device (Bleeper Sv, Vertec Scientific Ltd, Berkshire, UK) that provides real-time auditory feedback on radiation exposure during cardiac catheterization
16184825|NCT01510340|Behavioral|VIH-TAVIE|The tailored virtual intervention is composed of four interactive computer sessions hosted by a virtual nurse who engages the PLHIV in a medication-intake self-management skills-learning process.
16184826|NCT01510327|Device|PROMUS Element Everolimus-Eluting Coronary Stent System|PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
16184827|NCT01510327|Drug|Aspirin|Patients are required to take aspirin indefinitely after stent implant. It is recommended that aspirin 162-325 mg daily be given for at least 6 months after stent placement and that aspirin 75-162 mg daily be given indefinitely thereafter.
16184828|NCT01510327|Drug|Thienopyridine|Patients must be treated with one of the following thienopyridines for at least 6 months following the index procedure: clopidogrel 75 mg daily; or ticlopidine 250 mg twice daily; or prasugrel (outside the United States and if approved at the time of the procedure). If used, the prescribed dose should be in accordance with approved country-specific labeling. In patients not at high risk of bleeding, thienopyridine treatment should continue for at least 12 months after stent implant.
16184829|NCT01510314|Biological|C-reactive protein and procalcitonin dosages|
16184830|NCT01510301|Device|Mobile phone-based self-report system, electronic Patient-Reported Outcomes Measure (e-PROM)|"To test an electronic Patient-Reported Outcomes Measure (e-PROM) intended to assess patients' daily perceptions of symptoms and wellbeing, as well as self-measured blood pressure, treatment side-effects and medicine intake;
~Explore patient interactions (learning and understanding) with an internet-reporting system providing structured feedback of e-PROM results to examine if such feedback is useful in improving adherence;
~Explore patient-physician/nurse interactions to examine if structured feedback of e-PROM results serves as a useful complement to support consultations regarding treatment monitoring and adherence."
16184847|NCT01510158|Drug|Allopurinol|Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)
16184831|NCT01510288|Drug|GVAX and ipilimumab|All patients receive a 500 million cell priming dose of granulocyte-macrophage colony-stimulating factor-transduced allogeneic prostate cancer cells (GVAX) intradermally on day 1 followed by bi-weekly intradermal injections of 300 million cells for a 24 week period. The vaccinations are combined with monthly intravenous administrations of ipilimumab. The dose-escalation part of this study will be performed using the standard 3+3 phase-I trial design. Patients will be enrolled in cohorts of three; each cohort will receive an escalating dose of ipilimumab at 0•3, 1•0, 3•0 or 5•0 mg/kg. Sixteen patients will be treated in an expansion cohort with GVAX and 3•0 mg/kg ipilimumab.
16184832|NCT01510275|Device|Combined use of RESPIVOL® and RESPILIFT®|Active devices (combined) for 14 consecutive session, bid, for 15 minutes.
16184833|NCT01510275|Device|Combined use of RESPIVOL® and RESPILIFT®|Sham devices (combined) (without resistive load)for 14 consecutive session, bid, for 15 minutes.
16184834|NCT01510262|Behavioral|Tailored Socio-Contextual Intervention|"Develop strengths based case management intervention using input from interviews with repeat STI patients, consultants, & piloting.
~Recruit/enroll in the intervention 500 subjects (50% women; African American focus).
~After subjects receive STI diagnosis, treatment,& partner notification services, randomly assign subjects to:
~A. The STI strengths-based prevention case management, or B. Standard care.
~Assess participants' risk behavior, determinants of behavior & quality of life. Investigators will assess the incidence of new STI & test the efficacy of the intervention relative to control.
~Conduct a qualitative evaluation. Investigators will sample repeaters and non-repeaters from the experimental group.
~Conduct cost effectiveness analyses of intervention compared to the standard."
16184835|NCT01510262|Behavioral|Standard of Care|Currently, the total time spent in an STI exam w/men is 30 minutes & 60 w/women. More time is devoted to patients with sexual assault hx. Reason for the visit, symptoms, STI hx, contraception, condom use, number/gender of partners & number/type of sexual activities are assessed. The nurse takes a health hx and asks about typical HIV risks behavior. Due to time the risk assessment is 5 minutes. A risk reduction kit including condoms is issued. Information includes symptoms/treatment of STI, location of sexual health clinics, location of free condoms & testing/treatment resources. Referral information is provided when needed & more involved w/sexual assault survivors. Partner notification is conducted w/syphilis and HIV. This didactic process follows the medical model.
16184836|NCT01510236|Behavioral|Self-help program|The program is available via an internet platform (www.carebase.se) and consists of two steps: interactive support (Step 1) and cognitive behavioral therapy (CBT) delivered via internet (2). Step 1 provides information about the cancer experience and psychoeducation about frequent reactions and distress and how to manage this. The information and education is provided via texts, audio files, and video-interviews with persons who have survived cancer during adolescence. Step 1 also capitalizes on interaction between participants via chat and forum. There is also a possibility to ask questions to an expert via the website. Twenty-eight weeks after start of Step 1 participants are offered access to Step 2 which lasts ten weeks and consists of a self-help CBT material consisting of modules and weekly contact with a psychologist. Each module is focused on one problem area, e.g. worry or depressive symptoms. Step 1 is available during Step 2. The whole program lasts for 34 weeks.
16184837|NCT01510223|Dietary Supplement|Olive oil|"Each volunteer will complete three test trials. The first (CONTROL) and second test trials (HF) were separated by 28 days. The third trial (LF) takes place on the 6th day following the second trial (5 days apart).
~The CON and LF milkshake supplements are identical (272 kcal; 6 g fat). The basic control (CON) or LF milkshake (that the oil was added to) was: 275 g semi skimmed milk, 25 g chocolate milkshake mix, 15 g dried skimmed milk, 1 g xanthan gum. This was made up to 580 ml with still water.
~High-fat milkshake supplements were consumed daily for five days before a test trial. 90 g olive oil added to the supplement for the purpose of the HF intervention phase."
16184838|NCT01510223|Dietary Supplement|Olive oil and fish powder|"Each volunteer will complete three test trials. The first (CONTROL) and second test trials (HF) were separated by 28 days. The third trial (LF) takes place on the 6th day following the second trial (5 days apart).
~The CON and LF milkshake supplements are identical (272 kcal; 6 g fat). The basic control (CON) or LF milkshake (that the oil was added to) was: 275 g semi skimmed milk, 25 g chocolate milkshake mix, 15 g dried skimmed milk, 1 g xanthan gum. This was made up to 580 ml with still water.
~High-fat milkshake supplements were consumed daily for five days before a test trial. 86.67 g olive oil and 3.3 g of n-3 fish powder (500 mg EPA+DHA)added to the supplement for the purpose of the HF intervention phase."
16184839|NCT01510223|Dietary Supplement|Olive oil and macadamia oil|"Each volunteer will complete three test trials. The first (CONTROL) and second test trials (HF) were separated by 28 days. The third trial (LF) takes place on the 6th day following the second trial (5 days apart).
~The CON and LF milkshake supplements are identical (272 kcal; 6 g fat). The basic control (CON) or LF milkshake (that the oil was added to) was: 275 g semi skimmed milk, 25 g chocolate milkshake mix, 15 g dried skimmed milk, 1 g xanthan gum. This was made up to 580 ml with still water.
~High-fat milkshake supplements were consumed daily for five days before a test trial. 74.82 g olive oil and 15.18 g macadamia nut oil added to the supplement for the purpose of the HF intervention phase."
16184840|NCT01510223|Dietary Supplement|Deadaptation|A period of 5 days supplementation with the low-fat milkshake represents a de-adaptation period from high-fat intervention.
16184841|NCT01510184|Drug|Zevalin (ibritumomab tiuxetan)|Day 1: Rituximab 250 mg/m2 intravenous infusion Days 7-9:Rituximab 250 mg/m2 intravenous infusion followed by Y-90-Zevalin 14.8 MBq/kg. In centers where biodistribution imaging is performed Day 1: Rituximab 250 mg/m2 intravenous infusion followed by In-111-Zevalin 185 MBq (5mCi), Days 3-4: Biodistribution imaging Days 7-9: Rituximab 250 mg/m2 intravenous infusion followed by Y-90-Zevalin 14.8 MBq/kg
16184842|NCT01510171|Drug|Prasugrel|25 patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed ) will be enrolled to receive 60 mg Prasugrel loading dose before PPCI. The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In the case of vomit in the 2 hours after drug loading dose a new loading dose will be administered.
16184843|NCT01510171|Drug|Ticagrelor|25 patients with STEMI undergoing PPCI with bivalirudin (GP IIb/IIIa not allowed ) will be enrolled to receive 180 Ticagrelor loading dose before PPCI. The loading dose will be performed as soon as possible in the Emergency Room or in the Cath Lab. In the case of vomit in the 2 hours after drug loading dose a new loading dose will be administered.
16184844|NCT01510158|Drug|Lesinurad|Tablets, 200 mg once daily (qd)
16184845|NCT01510158|Drug|Lesinurad|Tablets, 400 mg qd
16184846|NCT01510158|Drug|Placebo|Tablets, Placebo qd
16184848|NCT01510158|Drug|Allopurinol|Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)
16184849|NCT01510158|Drug|Allopurinol|Tablets, ≥ 300 mg QD (≥ 200 mg qd for subjects with moderate renal impairment)
16184850|NCT01510145|Drug|Travoprost 0.004% BAK-free|Containing Polyquad (PQ) preservative
16184851|NCT01510132|Drug|Travoprost/timolol fixed combination (Travacom)|Commercially-marketed drug for the treatment of open-angle glaucoma or ocular hypertension
16184852|NCT01510119|Drug|Hydroxychloroquine|
16184853|NCT01510119|Drug|RAD001|
16184854|NCT01510093|Drug|Insulin Aspart 100 IE/ml|1.5 IE/hour/subject/visit. Each vist takes 10 hours
16184855|NCT01510080|Behavioral|Computer-assisted live supervision|8 BITE sessions, 4 video-based sessions (each 50 minutes) during treatment of 2 patients
16184856|NCT01510080|Behavioral|Delayed video-based supervision|12 video-based sessions (each 50 minutes) during treatment of 2 patients
16184857|NCT01510041|Other|Inspiratory muscle training|A group will be associated with inspiratory muscle training (GTMI). The inspiratory muscle strength training will be done in the POWERbreathe ®, and the patient will breathe for two minutes, seven times with one minute rest between them, with 15% MIP, the first week, then, increased 5-10% to reach 60% of the initial MIP after four weeks. After the first month, every fifteen days the charge will be adjusted to 60% of the new value of MIP. The breathing pattern will remain free
16184858|NCT01510041|Other|Respiratory exercise|Specific exercise program for mobility and biomechanics of the rib cage, as exercises of the trunk and upper limbs, and stretching of large muscle groups of the trunk.
16184859|NCT01510028|Biological|Recombinant human arylsulfatase A|6 patients treated with HGT-1110 EOW by IT injection
16184860|NCT01510015|Drug|Risperidone|variable dose
16184861|NCT01510002|Procedure|Total thyroidectomy|Extracapsular total thyroidectomy
16184862|NCT01510002|Procedure|Total thyroidectomy + prophylactic central neck dissection|Extracapsular total thyroidectomy plus prophylactic central neck dissection
16184863|NCT01509976|Other|triclosan/triclocarban-containing personal care products|Subjects will be randomly assigned to one of two arms with either triclosan/triclocarban-containing personal care products or products without triclosan/triclocarban. After 5 months, each subject will cross over to the other arm.
16184864|NCT01509963|Other|no intervention : measure of score|To provide probability of non sentinel lymph node metastasis in case of metastatic lymph node according to MSKCC nomogram and Tenon score.
16184865|NCT01509950|Procedure|Staples|Staples for closure of cesarean section skin incision
16184866|NCT01509950|Procedure|Prolene non-absorbable sutures|Prolene non-absorbable sutures for closure of cesarean skin incision
16184867|NCT01509950|Procedure|Absorbable Sutures|Absorbable sutures for closure of cesarean skin incision
16184868|NCT01509937|Device|body bioimpedance spectroscopy device|Name of the device is BCM from Fresenius Medical Care D GmbH
16184869|NCT01509937|Device|Device|participants in control arm will not receive BCM measurement.
16184870|NCT01509924|Other|Physical activation on Prescription|The advice on physical activity is patient oriented and based on FYSS (FYSS is a information bank that summarizes the up-to-date scientific knowledge on how to prevent and treat various diseases and conditions using physical activity). An individual prescription on physical activity is issued. The prescription form reminds of an ordinary drug prescription and provides specified types of physical activities including intensity, frequency and duration of the respective activities. The prescribed physical activity could be either self-monitored or organized by public physical activity organizations.
16184871|NCT01509911|Drug|TL-118|TL-118 investigational product is supplied as an oral liquid for daily administration at a specific dosing regimen. Treatment protocol includes weekly therapy cycles.
16184872|NCT01509911|Drug|Gemcitabine|Monthly cycles of 3 weekly treatments a month and one week off of treatment
16184873|NCT01509898|Device|Water jet|use of water jet for a month
16184874|NCT01509872|Behavioral|Trauma Focused Cognitive Behavioral Therapy|9 sessions of manualised, culturally modified, group-based trauma-focused cognitive behavioral therapy
16184875|NCT01509872|Behavioral|Child Friendly Space|9 sessions of a manualised, culturally appropriate, non trauma-focused psychosocial intervention
16184876|NCT01509859|Device|PFNA proximal femur nail device (Synthes)|"synthes PFNA proximal femur nail device"
16184877|NCT01509859|Device|INTERTAN proximal femur nail device (Smith&Nephew)|"Smith&Nephew INTERTAN proximal femur nail device"
16184878|NCT01509846|Biological|Vaccine: 2.6±0.8 x 10^8 vp/mL, 1 dose|Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^8 vp/mL administered on Day 0
16184879|NCT01509846|Biological|Vaccine: 2.6±0.8 x 10^9 vp/mL, 3 doses|Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^9 vp/mL administered on Days 0, 28, and 56
16184880|NCT01509846|Biological|Vaccine: 2.6±0.8 x 10^10 vp/mL, 3 doses|Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^10 vp/mL administered on Days 0, 28, and 56
16184881|NCT01509846|Biological|Vaccine: 2.6±0.8 x 10^11 vp/mL, 3 doses|Shigella flexneri 2a whole cell killed vaccine (Sf2aWC): 2.6±0.8 x 10^11 vp/mL administered on Days 0, 28, and 56
16184882|NCT01509846|Biological|Placebo: 1-3 doses|Placebo administered on Day 0 (if 1 dose) or Day 0, 28, and 56 (3 doses)
16184883|NCT01509833|Drug|rFSH|Administration of rFSH for ovarian stimulation.
16184884|NCT01509833|Drug|hCG|Administration of late follicular low dose hCG(100IU) for ovarian stimulation.
16184885|NCT01509833|Drug|hCG|Administration of late follicular low dose hCG(200IU) for ovarian stimulation.
16184886|NCT01509807|Drug|IV morphine sulfate or Sponsor-approved equivalent|Patients enrolled in this group will receive IV morphine sulfate or Sponsor-approved equivalent via a patient-controlled analgesia (PCA) pump, as needed.
16184887|NCT01509807|Drug|EXPAREL|Patients enrolled in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
16184947|NCT01509313|Device|hysteroscopic morcellator (TruClear)|It can be used to treat uterine pathology with a mechanical cutting edge
16184948|NCT01509313|Device|Bipolar Electrical resectoscope (Versapoint)|It can be used to treat uterine pathology with an electrical cutting edge
16184888|NCT01509794|Other|Low Valence|Participants in the low valence condition will participate in two photo-based simulations: first, an orientation to become familiar with the interface, and then a clinical simulation. Afterward, they will complete a written debriefing followed by an verbal debriefing with a study investigator. They will complete all activities while having their heart rate and galvanic skin response monitored using non-invasive methods.
16184889|NCT01509794|Other|High Valence|Participants in the low valence condition will participate in two video-based simulations: first, an orientation to become familiar with the interface, and then a clinical simulation. Afterward, they will complete a written debriefing followed by an verbal debriefing with a study investigator. They will complete all activities while having their heart rate and galvanic skin response monitored using non-invasive methods.
16184890|NCT01509781|Procedure|Insertion of suction drain(s) following mastectomy|One suction drain (16 Ch Redon drain) following simple mastectomy and two following modified radical mastectomy.
16184891|NCT01509781|Procedure|Adaptive skin sutures.|Subcutis of skin flaps of the axilla and the wound edges are adapted to the chest wall and pectoralis major muscle by 8 to 24 stitches (depending on the wound surface of the breast and axilla) using 3.0 absorbable sutures, in a distance of 4-5 cm from each other in a chessboard pattern. The wound is then closed with 3.0 running subcutaneous sutures and 4.0 intracutaneous stitches. Compressive dressing is applied on the chest in the first 12-24 hours after surgery.
16184892|NCT01509755|Drug|placebo|Once daily injection, under the skin (s.c.) for 12 weeks
16184893|NCT01509755|Drug|liraglutide|Once daily injection, under the skin (s.c.) for 12 weeks
16184894|NCT01509755|Drug|glimepiride|Tablets administered orally according to current treatment guidelines. Dose adjusted according to the glycaemic response
16184895|NCT01509742|Drug|liraglutide|Single dose of 7.5 mcg/kg, injected subcutaneously followed by a hypoglycaemic clamp by concentration measurement
16184896|NCT01509742|Drug|placebo|Single dose injected subcutaneously followed by a hypoglycaemic clamp by concentration measurement
16184897|NCT01509729|Procedure|Sham operation|A randomized group of patients received a placebo patch. As a supplement, each patient was given a dose of morphine, as required.
16184898|NCT01509729|Procedure|Knee arthroscopic surgery|A randomized group of patients was given small patches with active 5% lidocaine.
16184899|NCT01509703|Procedure|High flow therapy|Each patient is treated with nasal high flow at different flow rates (15, 30, 45L/min). The order of flow rates is randomized. Each flow rate will be used for 15 minutes. A wash out time of ten minutes is planned after each phase, during which the patient uses his his individual oxygen flow.
16184900|NCT01509690|Other|Multidisciplinary, intensive and collaborative care|"No specific study drugs, devices or procedures are involved.
~Subjects will be seen in a multidisciplinary, intensive management clinic involving a renal physician, a clinical pharmacist trained in renal pharmacotherapy and a renal coordinator. The main aim of this clinic is to provide multidisciplinary, intensive and consistent care in the first 3 to 4 months after HD initiation to streamline the management of the patients. Specific objectives of this clinic include providing patients with educational materials and information to enable a better understanding of their disease process, providing uniform anemia and renal bone disease management, increasing permanent HD access [arteriovenous (AV) fistula or graft] placement, increasing transplant referrals, providing suitable vaccinations to all patients, as well as reducing hospitalizations for fluid overload, uncontrolled hypertension and anemia-related complications."
16184901|NCT01509677|Drug|Roflumilast|500 μg tablet, once daily, oral administration in the morning after breakfast
16184902|NCT01509677|Drug|Placebo|tablet, once daily, oral administration in the morning after breakfast
16184903|NCT01509664|Behavioral|Discount intervention|50% discount on selected fruits and vegetables at participating supermarket
16184904|NCT01509651|Drug|Sugammadex|After the induction of anaesthesia, monitoring neuromuscular function is initiated and performed continuously using the TOF-Watch SX (Organon Ireland Ltd, Ireland) at the thumb. Repetitive train-of four (TOF) stimulation is applied every 15 s at the ulnar nerve until the end of anaesthesia, at least until recovery of the TOF ratio to 0.9 after administration of sugammadex. Each patient receives a single IV bolus dose of rocuronium 0.6 mg kg-1, after which tracheal intubation is performed. Maintenance doses of rocuronium 0.1 mg kg-1, are permitted as required and administered at the reappearance of the second twitch in the TOF. On reappearance of the second twitch at the end of surgery, patients receive a single IV bolus dose of sugammadex, 2.0 mg kg-1, for reversal.
16184905|NCT01509638|Drug|Group 1 Standard of Care|Patients in this group will receive IV morphine sulfate or Sponsor-approved equivalent via PCA pump, as needed.
16184906|NCT01509638|Drug|Group 2 EXPAREL|Patients in this group will receive 266 mg EXPAREL diluted with preservative-free 0.9% normal saline to a total volume of 30cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
16184907|NCT01509625|Drug|Fulvestrant|It is an observacional retrospective study to asses the results of the administration of fulvestrant in the routine clinical practice.
16184908|NCT01509612|Drug|Additive classical homeopathy|Homeopathic remedies every 2 to 3 months
16184909|NCT01509612|Drug|Homeopathic Placebo globules|Homeopathic placebo globules every 2 to 3 months
16184910|NCT01509599|Procedure|Cryotherapy: Cooling gel wrap|Patients will wear compression stockings (provided), elevate legs on an elevator pillow (provided) and apply the sham cyrotherapy: cooling gel wrap during the home-based intervention
16184911|NCT01509599|Procedure|Usual care|Patients will wear compression stockings (provided), elevate legs on an elevator pillow (provided) and apply the sham cyrotherapy wrap (sham) during the home-based intervention
16184912|NCT01509586|Drug|Potentially Reduced Exposure Product (PREP): a smokeless, spit-free tobacco product|The PREP Group will be given a sample supply of a PREP product that is already on the market. It is unclear if it is safer than cigarettes, and that is why it is classified as a Potentially Reduced Exposure Product. It provides both nicotine and tobacco in the form of a pouch that can be thrown away after used. Unlike chewing tobacco, there is no need for spitting with this product. There are multiple flavors and participants will have his/her choice of preferred flavor. This group will be asked to sample the product and use it in several ways, but whether a participant uses the product or not is up him/her.
16184949|NCT01509300|Biological|anti-thymocyte globulin|On days -10 to -9
16184913|NCT01509573|Behavioral|Family Strengthening Intervention in Rwanda (FSI-R)|"Core components of the FSI-R are derived from the FBPI theoretical framework, and were chosen to address key risk factors identified in qualitative data. The FSI-R holds separate preliminary meetings with caregivers and children to prepare for a larger family meeting. In these modules, the interventionist helps caregivers and children prioritize concerns or key messages that they most want to share with the other party. Role play and discussions are used to impart improved parenting and communication skills. In the family meetings, children and caregivers share their concerns with one another and develop a shared family narrative, which integrates past events into a singular story with shared goals and a future orientation. These family modules also discuss the services and supports (formal and non-formal resources) that the family can engage with in order to achieve their shared goals.
~8-12 weeks for 1-2 hours per week, depending on each family's pace and coverage of the material."
16184914|NCT01509560|Drug|Everolimus|"Start therapy: 2x 0.75 mg/day (morning and evening) to receive a serum trough level of 3 - 5 ng/ml. First evaluation of Everolimus serum level 3-7 days after start of therapy, second 7 days later, subsequently on study weeks 4, 6, 9, 12 and 16. Dose has to be adapted if trough level exceeds 5 ng/ml. As soon as Everolimus trough level exceeds 3 ng/ml after start of therapy, calineurine inhibitors (e.g. cyclosporine) will be reduced: halve of the dose for the 3 consecutive days, withdrawal on day 4.
~Prednisone will be reduced accordingly (a 22 weeks scheme is recommended) Everolimus will be used for 98 days or 14 weeks, as described above Everolimus therapy might be extended (independently of the study) if the patient suffering from milde chronic GvHD (according to NIH criteria) or milde PTOLD and lung function score is not reduced more than 25% since begin of Everolimus therapy Everolimus will be reduced to 50% of the dosage for 2 weeks before withdraw (normally weeks 15 and 16"
16184915|NCT01509547|Drug|Varenicline|participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.
16184916|NCT01509547|Drug|placebo|participants >55 kg will take varenicline/placebo 0.5 mg once daily for 3 days, titrated to 0.5 mg twice daily for 4 days, titrated to 1 mg twice daily thereafter. Participants ≤55 kg will take varenicline/placebo 0.5 mg once daily for 7 days, titrated to 0.5 mg twice daily thereafter.
16184917|NCT01509521|Drug|Ephedrine|An infusion with a maximum of 3 mg/minute for maximum 60 minutes or if sideeffects develope.
16184918|NCT01509521|Drug|Phenylephrine|An infusion of maximum 4 mg/hour for maximum 60 minutes.
16184919|NCT01509508|Drug|Immediate ARV treatment initiation with TDF/FTC/EFV|"All HIV-infected adults will be offered ART regardless of their immunological and clinical staging.
~The first line regimen proposed will be Atripla (R), a fixed dose combination containing tenofovir disoproxil (245 mg)/emtricitabine (200 mg)/efavirenz (600 mg)(FTC/TDF/EFV). The dosing will be 1 tablet OD."
16184920|NCT01509508|Other|South African recommendation guided ARV (TDF/FTC/EFV) initiation|"HIV-infected adult participants will be eligible for ART as per the South African guidelines (August 2011) if:
~CD4 count ≤ 350 cells/mm3 irrespective of clinical symptoms
~WHO clinical stage 3 or 4 irrespective of CD4 count
~MDR or XDR TB The first line regimen proposed will be Atripla (R), a fixes dose combination containing tenofovir disoproxil (245 mg)/emtricitabine (200 mg)/efavirenz (600 mg)(TDF/FTC/EFV). The dosing will be 1 tablet OD."
16184921|NCT01509495|Device|Akern BIA101 and Custom Device|Impedance Measurement every 4 hours
16184922|NCT01509482|Other|blood samples|blood samples to test for primary and secondary outcome measures
16184923|NCT01509482|Other|Blood samples|IR Cholesterol HDL LDL Fasting Glucose Triglycerides
16184924|NCT01509469|Dietary Supplement|Casein|Ileal infusion of low dose casein (5 gram)
16184925|NCT01509469|Dietary Supplement|Casein|Ileal infusion of high dose casein (15 gram)
16184926|NCT01509469|Dietary Supplement|Sucrose|Ileal infusion of low dose sucrose (4.3 gram)
16184927|NCT01509469|Dietary Supplement|Sucrose|Ileal infusion of high dose sucrose (12.9 gram)
16184928|NCT01509469|Other|Saline|Ileal infusion with saline (180mL in total)
16184929|NCT01509469|Dietary Supplement|Safflower oil|Ileal infusion with safflower oil (6gr safflower oil in water)
16184930|NCT01509456|Dietary Supplement|Potassium Bicarbonate|90 mmol daily, effervescent tablets 30 mmol diluted in 200 ml tab water supplemented three times a day together with the main meals for 21 days of HDT- bedrest
16184931|NCT01509443|Other|Exercise|Participants will perform 2-4 sessions of the prescribed exercise every day (One session: deep breathing 5-10 times; upper body stretching 5-10 times).
16184932|NCT01509430|Other|Progressive Resistance Exercise Training|12 weeks of Progressive Resistance Exercise Training followed by 12 weeks of self chosen training
16184933|NCT01509430|Other|Progressive Resistance Exercise Training|12 weeks of self chosen training followed by 12 weeks of progressive resistance exercise training
16184934|NCT01509417|Other|ad lib feedings after pyloromyotomy|ad lib feedings after pyloromyotomy
16184935|NCT01509417|Other|FLAP diet after pyloromyotomy|FLAP diet after pyloromyotomy
16184936|NCT01509404|Drug|Valganciclovir|Valcyte per package insert guidelines for 200 days post transplant
16184937|NCT01509404|Biological|CMV hyperimmune globulin|100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant
16184938|NCT01509404|Drug|Valganciclovir|valganciclovir per package insert guidelines for prophylaxis against CMV infection for 200 days post-transplant
16184939|NCT01509391|Drug|keyhole-limpet hemocyanin|Subcutaneous administration keyhole-limpet hemocyanin
16184940|NCT01509365|Drug|clopidogrel|2 tablets of 75 mg clopidogrel for one month followed by standard 75 mg clopidogrel for 3 months to one year.
16184941|NCT01509365|Drug|clopidogrel|1 tablet of 75 mg clopidogrel for one month followed by standard 75 mg clopidogrel for 3 months to one year.
16184942|NCT01509352|Procedure|esophageal stitches during fundoplication|placement of esophageal stitches with fundoplication
16184943|NCT01509352|Procedure|no esophageal stitches placed during fundoplication|no esophageal stitches are placed during the fundoplication procedure
16184944|NCT01509339|Drug|Vancomycin|250 mg vancomycin in 5cc sterile water will be inhaled once. Patients will use a Pari Sprint nebulizer and Pari Vios compressor as the delivery system.
16184945|NCT01509326|Other|chiropractic treatment|12 sessions over 4 weeks
16184946|NCT01509326|Device|Dr. Zaxx pillow|Daily use of an acupressure pillow
16184950|NCT01509300|Biological|filgrastim|Beginning on day 4 and continuing until blood counts recover
16184951|NCT01509300|Radiation|Total body irradiation|2Gy D-6 to D-4
16184952|NCT01509300|Drug|Fludarabine|30mg/M2 once daily IV on days -8 to -4
16184953|NCT01509300|Drug|cyclophosphamide|60 mg/kg IV on day-3 and -2
16184954|NCT01509300|Drug|Tacrolimus|begin on 0
16184955|NCT01509300|Drug|Mycophenolate mofetil|begin on 0
16184956|NCT01509300|Drug|Rituximab|375mg/m2 on day +21
16184957|NCT01509274|Biological|Plasma|3 ml plasma injected once into the plantar fascia
16184958|NCT01509274|Biological|Saline|3 ml of saline injected once into the plantar fascia
16184959|NCT01509274|Other|Physiotherapy + heel cap|Physiotherapy three times a day for 8 weeks. Heel caps until symptoms are gone
16184960|NCT01509261|Drug|Ilaprazole|20mg/Tap, QD
16184961|NCT01509261|Drug|Lansoprazole|30mg/Tap, QD
16184962|NCT01509235|Procedure|Chest physiotherapy|The whole exercise session consisted of three short period of exercise of 5 minutes each entirely done under the physiotherapists' supervision (FA).
16184963|NCT01509222|Behavioral|Personalized nutrition counseling|
16184964|NCT01509209|Drug|Pseudoephedrine / Levocetirizine|tablet, BID everyday
16184965|NCT01509196|Drug|HIP0901 / Lipidilsupra|HIP0901 capsule(Fenofibric acid, 135mg) / Lipidilsupra tablet(Fenofibrate, 160mg)
16184966|NCT01509183|Device|Propeller Health System (formerly Asthmapolis System)|The Propeller (formerly Asthmapolis) system works through the provision of information to patients and their providers. With the Propeller (formerly Asthmapolis) device in place, each actuation of a patient's rescue inhaler is recorded with an automatic time stamp; in many circumstances, the location at which the device is actuated is also captured and recorded. Actuation data are then securely transmitted to Propeller (formerly Asthmapolis) where events and an assessment of asthma control can be viewed in secure online interfaces. The information is also compiled into individual reports that are returned to the patient and his or her provider. Patients also receive customized suggestions for asthma management based on their actuation history.
16184967|NCT01509157|Device|MDRS System (Remote & Safety diabetes management system)|Participants will be using the MDRS system combined with their regular Continuous Glucose Monitoring during nightime for 2 weeks. The MDRS will allow the supervising personal to get real time remote data of glucose level and to alarm the patients and intervene in cases such as pending hypoglycemia, long standing hyperglycemia or technical faults
16184968|NCT01509157|Procedure|Continuous Glucose Monitoring|Participants will be using their regular Continuous Glucose Monitoring during nightime for 2 weeks, without using the MDRS remote control system
16184969|NCT01509144|Biological|EN41-FPA2 HIV vaccine|Group 1 Nasal vaccine - Low-dose (20 µg in 40 µL) IM vaccine (200 µg in 400 µL)
16184970|NCT01509144|Biological|EN41-FPA2 HIV vaccine|Group 2 Nasal vaccine - Mid-dose (100 µg in 200 µL) IM vaccine (200 µg in 400 µL)
16184971|NCT01509144|Biological|EN41-FPA2 HIV vaccine|Group 3 Nasal vaccine - Full-dose (200 µg in 400 µL) IM vaccine (200 µg in 400 µL)
16184972|NCT01509144|Biological|EN41-FPA2 HIV vaccine|Group 4 Nasal Placebo - 400 µL IM vaccine (200 µg in 400 µL)
16184973|NCT01509144|Biological|Na Cl Placebo vaccine|Group 5 Nasal placebo - 40 µL in Cohort 1 / 200 µL in Cohort 2 IM placebo (400 µL)
16184974|NCT01509131|Drug|2L PEG-CS plus bisacodyl|Patients will be asked to take 2L of Lovolesse and bisacodyl (10-20 mg according to patient bowel habit)
16184975|NCT01509131|Drug|2L PEG-ASC|Patients will asked to take PEG-ASC according to labeling instructions
16184976|NCT01509105|Biological|13-valent pneumococcal vaccine|0.5mL IM (Intramuscular administration) as per recommended schedule
16184977|NCT01509092|Procedure|vitrectomy surgery|"pars plana vitrectomy +internal limiting membrane peeling done immediately after the identification of the macular hole"
16184978|NCT01509079|Drug|Vitamin D3|Cholecalciferol capsule, 4000IU, daily for 6 months
16184979|NCT01509079|Drug|Vitamin D3|cholecalciferol capsule, 600 IU, daily for 6 months
16184980|NCT01509066|Other|Diet|Dietary approaches for PCOS
16184981|NCT01509053|Drug|Aripiprazole (Abilify®) IM Depot Injection|"400 mg IM depot injection every 26-30 days. Dosage may be adjusted at the investigator's discretion to 300 mg.
~Number of injections: 6. Participants have the option of entering the extension phase of the study and continuing with injections every 26-30 days until the drug is either commercially available, or December 2014."
16184982|NCT01509053|Drug|Oral aripiprazole|Oral aripiprazole tablets 10-15 mg/day (up to 30 mg/day).
16184983|NCT01509040|Other|Standard Care|"Triple-lumen central venous catheter inserted for pressure monitoring. All patients to receive 500-mL bolus of intravenous crystalloid every 30 minutes to achieve central venous pressure of 8 to 12 mm Hg; vasopressors if mean arterial pressure less than 65 mm Hg; and vasodilators if mean arterial pressure is 90 mm Hg or above.
~Initiation and maintenance of therapeutic hypothermia, target core temperature of below 34°C via standard external cooling techniques.
~Percutaneous coronary intervention performed as soon as feasible in patients with ST elevation or left bundle branch block on initial ECG.
~Serum biochemistry (including sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate) monitored every 6 hours."
16184984|NCT01509040|Device|Low Volume Hemofiltration|"Patients will receive isovolemic HF at a blood flow rate of 250 mL/min and ultrafiltration rate of 45 mL/kg/h for 48 hours. Initial replacement solution will be Prismasol BGK4/2.5. 3.1mg/dL phosphate (1.0 mmol/L) added to each bag. Replacement fluid adjusted as required based on chemistry values for sodium, potassium, bicarbonate, glucose, calcium, phosphate, magnesium and lactate.
~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution used. HF 1400 (i.e. polysulfone -based membrane) filters used throughout study. Hemofilter changed every 6 h after initiation of HF, and as required."
16185032|NCT01508767|Other|Removal of urethral catheter|All participants are to have a urethral catheter placed following successful placement of an epidural catheter for analgesia prior to undergoing colorectal resection. Following urethral catheter placement participants will be randomly assigned to either the experimental arm or the control arm. Participants assigned to the experimental arm will have their urethral catheters removed at 48 hours following surgery. Participants assigned to the control group will have their urethral catheters removed within 12 hours of withdrawal of the epidural infusion, as is standard practice in our institution.
16184985|NCT01509040|Device|High Volume Hemofiltration|"Patients allocated to high volume HF will receive HF at 250 mL/h blood flow rate and 90 mL/kg/h ultrafiltration rate for 48 hours. All other care will be identical to that provided in the low volume HF group.
~Vascular access for HF will be via an 11.5-F, double-lumen venous catheter in a central vein. The hemofiltrate will be replaced by fluid infused into the bloodstream before (i.e. predilution) and after (i.e. postdilution) the filter. A fixed ratio of 80:20 predilution:postdilution will be used. HF 1400 (i.e. polysulfone -based membrane) filters will be used throughout the study. The hemofilter will be changed every 6 h after initiation of HF, and otherwise as required."
16184986|NCT01509027|Behavioral|education by DVD|Information on detrimental conseqences of hyperphosphatemia is presented on DVD
16184987|NCT01509027|Behavioral|Standard care|standard care
16184988|NCT01509027|Behavioral|Education by DVD and dietician|Information on detrimental conseqences of hyperphosphatemia is presented on DVD and individual dietary counseling is given by dieticican
16184989|NCT01509014|Behavioral|CPATCH intervention to support statin adherence|Routine identification of new statin users (first year of therapy), consistent assessment of barriers to adherence at every dispensation for these patients, reassurance about efficacy and safety, and proactive response to identified adherence barriers.
16184990|NCT01509001|Drug|Metformin|750 to 2500 mg/day, two times a day during 4 months
16184991|NCT01509001|Drug|Glimepiride|1 to 8 mg/day , two times a dya, during 4 months.
16184992|NCT01508988|Drug|ONO-9054|Eye drops 0.3 µg/mL both eyes on Day one
16184993|NCT01508988|Drug|ONO-9054|Eye drops 1 µg/mL both eyes on Day one
16184994|NCT01508988|Drug|ONO-9054|Eye drops 3 µg/mL both eyes on Day one
16184995|NCT01508988|Drug|ONO-9054|Eye drops 10 µg/mL both eyes on Day one
16184996|NCT01508988|Drug|ONO-9054|Eye drops 20 µg/mL both eyes on Day one
16184997|NCT01508988|Drug|ONO-9054|Eye drops 30 µg/mL both eyes on Day one
16184998|NCT01508988|Drug|ONO-9054|Matched-placebo eye drops dosed in the same manner as ONO-9054 in both eyes on Day one
16184999|NCT01508975|Other|White Rice, Brown Rice, Glucose|white rice, brown rice, glucose
16185000|NCT01508949|Drug|liraglutide|Once daily dosing of 0.6 mg for 8 weeks, injected subcutaneously
16185001|NCT01508949|Drug|placebo|Once daily dosing of 0.6 mg for 8 weeks, injected subcutaneously
16185002|NCT01508936|Drug|Reslizumab|Reslizumab administered at a dosage of 3.0 mg/kg by intravenous (iv) infusion by qualified study personnel every 4 weeks for 16 weeks (for a total of 4 doses).
16185003|NCT01508936|Drug|Placebo|Matching placebo administered by intravenous (iv) infusion by qualified study personnel every 4 weeks for 16 weeks (for a total of 4 doses).
16185004|NCT01508923|Drug|liraglutide|6 mcg/kg injected subcutaneously daily in each treatment period in random order. In total, subjects are treated 9-10 days
16185005|NCT01508923|Drug|placebo|6 mcg/kg injected subcutaneously daily in each treatment period in random order. In total, subjects are treated 9-10 days
16185006|NCT01508910|Biological|Auto-CD34+ cells|10 intramyocardial injections of 0.2 mL per injection site of Auto-CD34+ cells
16185007|NCT01508910|Biological|Placebo: Diluent used to suspend Auto-CD34+ cells|10 intramyocardial injections of 0.2 mL per injection site of placebo
16185008|NCT01508910|Other|Standard of care|Standard of care for refractory angina
16185009|NCT01508897|Drug|liraglutide|Single dose administered as subcutaneous injection
16185010|NCT01508897|Drug|liraglutide|Single dose administered as subcutaneous injection
16185011|NCT01508884|Biological|influenza vaccine|single dose of intradermal 15 mcg non-adjuvanted 2011/2012 trivalent influenza vaccine
16185012|NCT01508884|Drug|Imiquimod|pretreatment with topical imiquimod cream to the injection site before vaccination
16185013|NCT01508884|Biological|influenza vaccine|single dose of intradermal 15mcg non-adjuvanted 2011/2012 trivalent influenza vaccine
16185014|NCT01508884|Drug|Aqueous cream|pretreatment with topical aqueous cream to the injection site before vaccination
16185015|NCT01508884|Biological|influenza vaccine|single dose of intramuscular 15mcg non-adjuvanted 2011/2012 trivalent influenza vaccine
16185016|NCT01508884|Drug|Aqueous cream|pretreatment with topical aqueous cream to the injection site before vaccination
16185017|NCT01508871|Other|Observational study, no intervention|No intervention
16185018|NCT01508858|Drug|liraglutide|Administered with daily subcutaneous injections for approximately 3 weeks in each treatment period in random order
16185019|NCT01508858|Drug|placebo|Administered with daily subcutaneous injections for approximately 3 weeks in each treatment period in random order
16185020|NCT01508858|Drug|levonorgestrel / ethinylestradiol|One single oral tablet after the liraglutide or placebo dose administration at the end of each treatment period
16185021|NCT01508845|Dietary Supplement|cholecalciferol|800 IU vitamin D3, 1 dose; 800 IU deuterated vitamin D3, 1 dose
16185022|NCT01508845|Dietary Supplement|cholecalciferol|50,000 IU vitamin D3, 1 dose; 800 IU deuterated vitamin D3, 1 dose
16185023|NCT01508845|Dietary Supplement|cholecalciferol|50,000 IU vitamin D3, 1 dose; 800 IU vitamin D3, 1 dose
16185024|NCT01508845|Dietary Supplement|cholecalciferol|50,000 IU vitamin D3, 1 dose; 800 IU deuterated vitamin D3, 1 dose
16185025|NCT01508832|Drug|Lidocaine Digital Nerve Block|Lidocaine 1% Digital Nerve Block (2 cc
16185026|NCT01508832|Drug|Bupivacaine Digital Block|Bupivacaine 0.25% Digital Block (2 cc)
16185027|NCT01508819|Other|recommendations to admit to ICU all the patients included|recommendations to emergency and ICU physicians to admit to ICU all the patients included in the trial
16185028|NCT01508806|Drug|liraglutide|Single dose of 0.75 mg, administered as a subcutaneous injection
16185029|NCT01508793|Behavioral|Optimize Sleep|Children are asked to increase their sleep by approximately 1 1/2 hours/night for the duration of the two month intervention
16185030|NCT01508780|Device|St Jude Medical C7 Dragonfly Optical Coherence Tomography (OCT)|All subjects will have OCT and IVUS imaging during their right heart catheterization.
16185031|NCT01508780|Device|Boston Scientific Intravascular Ultrasound|All subjects will have OCT and IVUS imaging during their right heart catheterization.
16185033|NCT01508754|Procedure|Continuous positive airway pressure treatment|Treatment with CPAP for 6 months, pressure will be titrated during a second polysomnography.
16185034|NCT01508741|Dietary Supplement|5-Aminolevulinic Acid (5-ALA)|5-ALA 50 mg. p.o. daily capsules taken over 6 weeks.
16185035|NCT01508741|Dietary Supplement|Placebo|Daily p.o. capsule of similar shape and color to active ingredient 5-ALA capsule taken over 6 weeks.
16185036|NCT01508728|Device|ORTHOSENS orthosis|with active vibration
16185037|NCT01508728|Device|ORTHOSENS orthosis|with placebo vibration
16185038|NCT01508715|Other|Shoulder resistive exercise|"Both groups will perform the seated full can, sidelying internal rotation (IR), sidelying external rotation (ER) with towel roll, supine protraction at 120° of flexion, sidelying horizontal abduction, sidelying abduction, and seated pulley extension using resistance weights in the participant's pain-free shoulder motion. One group will complete only the eccentric portion of the exercise actively, the other will complete only the concentric portion actively. The treating physical therapist will reposition the weights to avoid active resistance occuring in the opposite direction of the desired intervention. Both groups will use 70% of their predicted one repetition maximum (1RM), progressing to 80% with 1RM reassessed and training weight adjusted every two weeks."
16185039|NCT01508702|Drug|lesinurad|Tablets, 400 mg QD
16185040|NCT01508702|Drug|Placebo|Tablets, Placebo QD
16185041|NCT01508689|Behavioral|Receive Kellogg's Nutri-Grain® cereal bars first|First three weeks of study: consume perceived usual diet; Second three weeks of study: Receive 42 Kellogg's Nutri-Grain® cereal bars per person, consume 2 bars per day; Third three weeks of study: consume perceived usual diet
16185042|NCT01508689|Behavioral|Receive Kellogg's Nutri-Grain® cereal bars second|First six weeks of study: consume perceived usual diet; Last three weeks of study: Receive 42 Kellogg's Nutri-Grain® cereal bars per person, consume 2 bars per day
16185043|NCT01508676|Drug|Pennsaid|
16185044|NCT01508676|Drug|Placebo (2.3% DMSO solution)|
16185045|NCT01508663|Device|Everolimus Eluting Stent or Zotalolimus Eluting Stent|Everolimus Eluting Stent(Xience V, Xience prime) Zotalolimus Eluting Stent(Endeavor-resolute, Resolute Integrity)
16185046|NCT01508663|Drug|ARB, CCB, ACE-inhibitor, statin, Nitrate, Antiplate etc.|one or two anti-platelet agents, beta-blockers, calcium channel blockers, nitrates, angiotensin converting enzyme inhibitors (ACEIs) or angiotensin receptor blockers (ARBs), and statin
16185047|NCT01508650|Behavioral|Usual care|Usual care control group
16185048|NCT01508650|Behavioral|Rehabilitation intervention|Multi-domain rehabilitation intervention
16185049|NCT01508637|Other|Diesel Exhaust|Freshly generated diesel exhaust, diluted to 300 micrograms/cubic meter. Exposures are two hours in duration.
16185050|NCT01508637|Other|Filtered Air|Sham exposure, identical to conditions of diesel exhaust exposure, but with only air filtered of particles and volatile organic compound gases
16185051|NCT01508637|Drug|Terazosin|2 mg by mouth, 90 minutes prior to exposure initiation
16185052|NCT01508637|Drug|placebo|capsule, identical in appearance to terazosin capsule, by mouth, 30 minutes prior to exposure initiation
16185053|NCT01508624|Other|Interaction|Participants in this condition will interact with nurses during their surgery. The nurses will not touch the patient's hand during treatment as this intervention looks at interaction with another person, in the absence of tactile stimuli.
16185054|NCT01508624|Other|Music|Participants will be offered a choice of music to listen to from a selection at the clinic, they will also have the opportunity of bringing or selecting their own music which can be streamed from the internet. They will listen to the music through headphones
16185055|NCT01508624|Behavioral|Touch - stress balls|Participants will be provided with two stress balls which they will be encouraged to squeeze during their surgery and administration of the local anaesthetic
16185056|NCT01508624|Behavioral|DVD|participants will be given a choice of DVDs to watch during their procedure. A wall mounted screen will be positioned so that participants can comfortably view the screen during their procedure. they will listen to the accompanying audio through wireless headphones.
16185057|NCT01508611|Other|30% silver diammine fluoride|"The 30% silver diamine fluoride (Cariestop, Biodinamica) will be applied with a disposable microbrush for 3m. Then the surface will be washed for 30s.
~Anteroposterior toothbrushing technique will be explained to the children."
16185058|NCT01508611|Behavioral|Oral hygiene|With the patient's own brush, supervised brushing the erupting molar with fluoridated toothpaste will be guided using the cross-toothbrushing technique
16185059|NCT01508585|Behavioral|Telephone Based Cognitive Behavioral Therapy|6 sessions of Cognitive Behavioral Therapy (CBT), lasting approximately 60 minutes each.
16185060|NCT01508572|Drug|bevacizumab-IRDye800CW|In this two stage, non-randomized, non-blinded, prospective, multicenter feasibility study, bevacizumab-IRDye800CW will be administered to a total of 20 patients with proven breast cancer.
16185061|NCT01508546|Procedure|axillary dissection|Conservative breast surgery with or without axillary dissection
16185062|NCT01508494|Drug|Galantamine|16 mg galantamine daily P/O
16185063|NCT01508494|Drug|placebo|placebo
16185066|NCT01508455|Drug|Dexmedetomidine|
16185067|NCT01508455|Drug|Midazolam|
16185068|NCT01508455|Drug|Fentanyl|
16185069|NCT01508455|Drug|Morphine|
16185070|NCT01508429|Other|placebo|4 placebo tablets (resembling misoprostol) administered sublingually
16185071|NCT01508429|Drug|Misoprostol|800mcg misoprostol (4 200mcg tablets administered sublingually)
16185072|NCT01508390|Radiation|CyberKnife Boost|21 Gy in 7 Gy per day, 3 fractions, Every other day
16185093|NCT01508260|Procedure|Aquapheresis|Participant connected to aquapheresis pump through an intravenous (IV) catheter placed in forearm. Average treatment is about 24 hours but can extend up to 7 days.
16185094|NCT01508260|Drug|Furosemide|20-40 mg by vein every 8 hours as indicated for optimal diuresis to achieve negative fluid balance or 0.5 to 5 mg per hour by continuous infusion.
16185095|NCT01508247|Biological|inactivated vaccine (Vero Cell) against EV71|inactivated vaccine (vero cell) against EV71, 320U /0.5ml, two doses, on day0, 28
16185096|NCT01508247|Biological|0/0.5ml placebo|0/0.5ml placebo, two doses, on day0, 28
16186006|NCT01501591|Drug|Hydroxizine|25 mg orally, one time on two different days, 72 hours apart
16185073|NCT01508377|Behavioral|Exposure for PTSD with cognitive restructuring|"The treatment lasts five weeks. During that time-frame, participants write ten texts for 45 minutes, twice a week. Each time after having received two texts, the therapists provide feedback and further instructions, which are based upon the manual (Lange et al., 2003)
~The long version of the PTSD treatment (including cognitive restructuring) can be divided into three phases.
~First phase - self-confrontation (4 essays) At the beginning the participants receive psychoeducation about the mechanisms of exposure before writing four essays about their emotionally most painful memories.
~Second phase - cognitive restructuring (4 essays) Again the participants write four texts, however, this time they go beyond mere descriptions and use their experiences to write a supportive letter to an imaginary friend who had been through the same experience.
~Third phase - parting (2 essays) In the third phase, two texts are written in the form of a letter to document the past in a worthy document."
16185074|NCT01508377|Behavioral|Exposure for PTSD without cognitive restructuring|"The treatment lasts five weeks. During that time-frame, participants write ten texts for approximately 45 minutes, twice a week. Each time after having received two texts, the therapists provide feedback and further instructions, which are based upon the manual (Lange et al., 2003).
~The short version of the PTSD treatment can be divided into only two phases. Compared to the long version the phase dealing with cognitive restructuring is excluded.
~First phase - self-confrontation (4 essays) At the beginning the participants receive psychoeducation about the mechanisms of exposure before writing four essays about their emotionally most painful memories.
~Third phase - parting (2 essays) In the third phase, two texts are written in the form of a letter to document the past in a worthy document."
16185075|NCT01508364|Drug|Sorafenib (Nexavar, BAY 43-9006)|Dosage according to label or at discretion of the attending physician
16185076|NCT01508338|Dietary Supplement|Placebo|An oral placebo capsule will be taken each morning and three dosages of a placebo gel containing polydextrose will be taken 3 times daily for 12 weeks.
16185077|NCT01508338|Dietary Supplement|HMB|A placebo capsule will be taken each morning and three dosages of HMB gel, each providing 1 g of HMB, will be taken daily for a total of 3 g HMB per day for 12 weeks.
16185078|NCT01508338|Dietary Supplement|Peak ATP and HMB|One capsule containing 400 mg of Peak ATP will be taken in the morning and three dosages of HMB gel, each providing 1 g of HMB, will be taken daily for a total of 3 g HMB per day for 12 weeks.
16185079|NCT01508338|Dietary Supplement|ATP|One capsule containing 400 mg of Peak ATP will be taken daily in the morning and three dosages of a placebo gel containing polydextrose will be taken 3 times daily for 12 weeks.
16185080|NCT01508325|Drug|Bisoprolol|Subjects will receive bisoprolol fumarate (Concor®) at a dose of 5 milligram (mg) once daily orally as sustained release (SR) tablets for a period of 4 weeks. The dose of bisoprolol will be escalated to 7.5 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 10 mg orally once daily for the next 4 weeks (Weeks 8 to 12), if clinic systolic blood pressure (SBP) was greater than or equal to (>=) 140 millimeters of mercury (mmHg) and/or diastolic blood pressure (DBP) was >=90 mmHg measured every 4 weeks.
16185081|NCT01508325|Drug|Metoprolol|Subjects will receive metoprolol succinate (Betaloc SR) at a dose of 47.5 mg once daily orally as SR tablets for a period of 4 weeks. The dose of metoprolol will be escalated to 71.25 mg orally once daily for next 4 weeks (Weeks 4 to 8) and to 95 mg orally once daily for the next 4 weeks (Weeks 8 to 12) if clinic SBP was >=140 mmHg and/or DBP was >=90 mmHg measured every 4 weeks.
16185082|NCT01508312|Drug|brentuximab vedotin (SGN-35)|Patients will receive 2 cycles of weekly brentuximab vedotin, 1.2mg/kg on days 1, 8, and 15 of each 28 day cycle. Patients with pre-treatment positive bone marrow biopsies will have repeat bone marrow biopsies if the PET scan is negative. FDG-PET/CT will be repeated after 2 cycles of treatment within 1 week of the last dose of cycle 2. Patients with persistent abnormalities on FDG-PET/CT following 2 cycles of brentuximab vedotin will receive 2 cycles of augmented ICE. The first cycle of augmented ICE will be initiated 7-14 days after the last dose of SGN-35. FDG-PET/CT will be repeated within 7-14 days following the second cycle of augmented ICE. Stem cell mobilization can be performed following the first or second cycle of augmented ICE.
16185083|NCT01508312|Drug|Brentuximab Vedotin (SGN-35)|Patients will receive 2 cycles of weekly brentuximab vedotin, 1.2mg/kg on days 1, 8, and 15 of each 28 day cycle. FDG-PET/CT will be repeated after 2 cycles of treatment within 1 week of the last dose of cycle 2. Patients with pre-treatment positive bone marrow biopsies will have repeat bone marrow biopsies if the PET scan is negative. Patients with normalization of FDG-PET/CT and negative bone marrow biopsies following 2 cycles of brentuximab vedotin will undergo stem cell mobilization in preparation for ASCT.
16185084|NCT01508299|Procedure|skin test|skin test with the Suspected raw food
16185085|NCT01508286|Drug|Telaprevir + peginterferon alfa + ribavirin|During the first 12 weeks of the early access program, all eligible patients will receive telaprevir 750 mg every 8 hours in combination with peginterferon-alfa and ribavirin.
16185086|NCT01508286|Drug|peginterferon alfa + ribavirin|Patients with severe fibrosis who are treatment naïve or prior treatment relapsers will subsequently be treated with peginterferon-alfa and ribavirin alone for either an additional 12 or 36 weeks.
16185087|NCT01508286|Drug|peginterferon alfa + ribavirin|Previously treated patients with prior partial or null response, or who had viral breakthrough, with severe fibrosis and all subjects with cirrhosis will subsequently be treated with peginterferon-alfa and ribavirin alone for an additional 36 weeks.
16185088|NCT01508273|Behavioral|Exercise Program|Resistance training bands, guidebook, and pedometer given at baseline visit. Internet-based curriculum access given to teach goal-setting, overcoming barriers to physical activity, self-management strategies, and time-management skills. Access given website that will allow participant to track exercise behavior and help set goals.
16185089|NCT01508273|Behavioral|Website|Website access given that allows participant to track exercise behavior and help to set goals.
16185090|NCT01508273|Behavioral|Exercise DVD|Participants receive chair-based exercise DVD. Participants in this chair-based exercise program for a total of 8 weeks.
16185091|NCT01508273|Behavioral|Survey|"Exercise Intervention Program Group : Survey completion monthly about attitudes and beliefs about physical activity.
~Sedentary Behavior and Dietary Intervention Group: Survey completion monthly attitudes and beliefs about sedentary behavior and dietary intake."
16185092|NCT01508273|Behavioral|Self-Report Assessments|Self-report assessments given about quality of life and physical assessments of balance and coordination.
16185097|NCT01508221|Drug|Trental|400 mg tid starting first day after last radiosurgery treatment and continuing for 6 months
16185098|NCT01508221|Dietary Supplement|Vitamin E|400IU twice daily starting the first day after last radiosurgery treatment and continuing for 6 months
16185099|NCT01508208|Other|Hypertensive disorder of pregnancy|Collection of a random sample of urine for a spot test and a 24 hour urine collection for a 24 hour urine protein.
16185100|NCT01508195|Drug|Canagliflozin tablets|Type = exact number, unit = mg, number = 100, form = tablet, route = oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period 1.
16185101|NCT01508195|Drug|Metformin IR tablets|Type = exact number, unit = mg, number = 500, form = tablet, route = oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 1.
16185102|NCT01508195|Drug|Canagliflozin/metformin IR FDC tablets|Type = exact number, unit = mg, number = 50/500, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 2.
16185103|NCT01508195|Drug|Canagliflozin/metformin IR FDC tablets|Type = exact number, unit = mg, number = 50/500, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 1.
16185104|NCT01508195|Drug|Canagliflozin tablets|Type = exact number, unit = mg, number = 100, form = tablet, route = oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period 2.
16185105|NCT01508195|Drug|Metformin IR tablets|Type = exact number, unit = mg, number = 500, form = tablet, route = oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 2.
16185106|NCT01508182|Drug|Canagliflozin tablets|Type = exact number, unit = mg, number = 300, form = tablet, route = oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period 1.
16185107|NCT01508182|Drug|Metformin IR tablets|Type = exact number, unit = mg, number = 500, form = tablet, route = oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 1.
16185108|NCT01508182|Drug|Canagliflozin/metformin IR FDC tablets|Type = exact number, unit = mg, number = 50/500, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 2.
16185109|NCT01508182|Drug|Canagliflozin tablets|Type = exact number, unit = mg, number = 300, form = tablet, route = oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period 2.
16185110|NCT01508182|Drug|Metformin IR tablets|Type = exact number, unit = mg, number = 500, form = tablet, route = oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 2.
16185111|NCT01508182|Drug|Canagliflozin/metformin IR FDC tablets|Type = 2, unit = mg, number = 50/500, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 1.
16185112|NCT01508169|Device|Foot orthosis (Orthotics Unit of the Clinical Hospital of UNICAMP)|Custom foot orthoses made of ethylene-vinyl acetate (EVA) with medial arch supports and metatarsal pads (supporting the diaphysis of the second to fourth metatarsals) that were manufactured by the Orthotics and Prostheses Unit of the Clinical Hospital of UNICAMP.
16185113|NCT01508156|Drug|IDX719|IDX719 liquid suspension (1 - 100 mg) taken by mouth.
16185114|NCT01508156|Drug|Placebo|Placebo liquid suspension matching IDX719 taken by mouth.
16185115|NCT01508143|Drug|Misoprostol 400 micrograms|Misoprostol 400 micrograms each 6 hours for 8 dose
16185116|NCT01508143|Drug|Misoprostol 800 micrograms|Misoprostol 800 micrograms each 12 hours for 4 doses
16185117|NCT01508117|Drug|Axitinib|5 mg twice daily starting 21 days after resection and continuing until progression or unacceptable toxicity
16185118|NCT01508117|Radiation|Radiation Therapy|45 Gy in 15 fractions starting after 28 days of Axitinib monotherapy
16185119|NCT01508104|Drug|BEZ235|dose escalation 400mg- 1000mg per day
16185120|NCT01508104|Drug|Everolimus|dose escalation 2.5 to 5 mg per day
16185121|NCT01508091|Behavioral|energy restricted mediterranean-type diet|Prescription of diet 25 % lower than actual total energy expenditure in overweight or moderately obese premenopausal women
16185122|NCT01508091|Behavioral|25 % calorie restriction|25 % calorie restriction respect total energy expenditure
16185123|NCT01508065|Device|Glucometer CGM-305|The study procedure consists of three days trial. After each experimental day the results of blood glucose level reading from the non-invasive Glucometer CGM-305 will be compared to the reading from several devices, as following: Abbott Freestyle Libre, the hexokinase assay (YSI 2300 STAT Plus) from the venous and the laboratory blood measurements. First day of trial consists of 8-10 hours and is used to calibrate the non-invasive Glucometer CGM-305 for the specific patient. During the second and third days a fasting experiment is performed and consists of 4-6 hours.
16185124|NCT01508052|Device|sequential compression device|applying sequential compression device during the surgery
16185125|NCT01508052|Device|elastic stockings|applying elastic stockings during the surgery
16185126|NCT01508039|Other|Chitin Micro Particle|"The total spray volume for each application is 0.4 ml equivalent to a total single-dose for chitin of 2 mg (0.5 mg per 0.1 ml spray).
~A total single-dose for LPS, of 2 mg of endotoxin from Enterobacter agglomerans (0.5 mg per 0.1 ml spray)"
16185127|NCT01508026|Drug|Nebivolol and Valsartan 1|Fixed Dose Combination Nebivolol 5 mg and Valsartan 80 mg, oral administration, then dose doubled at Week 11 to Fixed Dose Combination Nebivolol 10 mg and Valsartan 160 mg, oral administration
16185128|NCT01508026|Drug|Nebivolol and Valsartan 2|Fixed Dose Combination Nebivolol 5 mg and Valsartan 160 mg, oral administration then dose doubled at Week 11 to Fixed Dose Combination Nebivolol 10 mg and Valsartan 320 mg, oral administration
16185129|NCT01508026|Drug|Nebivolol and Valsartan 3|Fixed Dose Combination Nebivolol 10 mg and Valsartan 160 mg, oral administration then dose doubled at Week 11 to Fixed Dose Combination Nebivolol 20 mg and Valsartan 320 mg, oral administration
16185130|NCT01508026|Drug|Nebivolol 1|Nebivolol Monotherapy 5 mg, oral administration, then dose doubled to at Week 11 to Nebivolol Monotherapy 10 mg, oral administration
16185131|NCT01508026|Drug|Nebivolol 2|Nebivolol Monotherapy 20 mg, oral administration, then dose doubled to at Week 11 to Nebivolol Monotherapy 40mg, oral administration
16185132|NCT01508026|Drug|Valsartan 1|Valsartan Monotherapy 80 mg, oral administration, then dose doubled to at Week 11 to Valsartan Monotherapy, 160 mg, oral administration
16185133|NCT01508026|Drug|Valsartan 2|Valsartan Monotherapy 160 mg, oral administration, then dose doubled to at Week 11 to Valsartan Monotherapy, 320 mg, oral administration
16185134|NCT01508026|Drug|Placebo|Dose matched placebo, oral administration
16190748|NCT01466244|Other|laboratory biomarker analysis|
16185135|NCT01508013|Behavioral|Appearance-Focused Website Intervention|The intervention is a teen-friendly website with information concerning the health and appearance effects of indoor tanning.
16185136|NCT01508013|Behavioral|Control Website|The control website contains information about alcohol and drug abuse which is oriented for a teen audience.
16185137|NCT01508000|Drug|FOLFOX6|5-FU, folinic acid, oxaliplatin
16185138|NCT01508000|Biological|Bevacizumab|Targeted therapy
16185139|NCT01508000|Biological|Panitumumab|Targeted therapy
16185140|NCT01508000|Procedure|Surgery|
16185141|NCT01507987|Device|Implanted with one or more of the following SJM leads: Riata leads, RiataST leads, Durata leads, and QuickSite/QuickFlex leads|"Riata leads implanted between 2002-2009 Riata ST leads implanted between 2006-2009 Quicksite or QuickFlex leads implanted between 2006-2010 Durata leads implanted between 2008-2010
~Subjects were followed for three years and cinefluoroscopy imaging was done annually to determine prevalence of externalized conductors or other visual lead anomalies"
16185142|NCT01507974|Drug|Preventive antibiotic treatment- NITROFURANTOIN|P.O NITROFURANTOIN 100 mg per day for 6 weeks
16185143|NCT01507974|Drug|Preventive antibiotic treatment- CEPHALEXIN|P.O CEPHALEXIN 500 MG PER DAY FOR 6 WEEKS
16185144|NCT01507974|Drug|PREVENTIVE TREATMENT- AMOXICILLIN|P.O AMOXICILLIN 250 MG PER DAY FOR 6 WEEKS
16185145|NCT01507974|Drug|PREVENTIVE TREATMENT- AMOXICILLIN AND CLAVULANATE POTASSIUM|P.O AMOXICILLIN AND CLAVULANATE POTASSIUM, 875 MG PER DAY FOR 6 WEEKS
16185146|NCT01507974|Drug|PREVENTIVE TREATMENT- CEFUROXIME|P.O CEFUROXIME 250 MG PER DAY FOR 6 WEEKS
16185147|NCT01507974|Drug|PREVENTIVE TREATMENT SULFAMETHOXAZOLE AND TRIMETHOPRIM|P.O SULFAMETHOXAZOLE AND TRIMETHOPRIM 1 TAB PER DAY FOR 6 WEEKS
16185148|NCT01507948|Behavioral|Prolonged exposure|PE will be delivered in 9-12 90-minute sessions. Therapy will be delivered by PhD-level therapists at Stanford and Palo Alto VA. PE consists of four components: psychoeducation about PTSD symptoms and the behavioral or cognitive factors maintaining it, a brief breathing retraining that can be used as a stress management tool, prolonged imaginal exposure to the trauma memory both within-session and repeated as homework, and prolonged in vivo exposure to avoided scenarios in patients' day-to-day lives.
16185149|NCT01507935|Other|Regular non-hydrolysed cow's milk|Regular non-hydrolysed cow's milk with added prebiotic oligosaccharides mixture I
16185150|NCT01507935|Other|Regular non-hydrolysed cow's milk|Regular non-hydrolysed cow's milk with added prebiotic oligosaccharides mixture II
16185151|NCT01507935|Other|Regular non-hydrolysed cow's milk|Regular non-hydrolysed cow's milk with the same composition as the Investigational Formulas but without supplementation of prebiotic oligosaccharides
16185152|NCT01507922|Drug|Fenoverine|Fenoverine 100mg three times a day for 8 weeks
16185153|NCT01507922|Drug|Timebutine|Timebutine maleate 150mg three times a day for 8 weeks
16185154|NCT01507896|Biological|Recombinant factor IX|Following a loading dose with BAX326, participants will receive BAX326 as a bolus infusion. The treatment regimen will be determined by the intensity and duration of the hemostatic challenge and the institution´s standard of care. The dose will be tailored to raise FIX concentration to at least 80%-100% of normal for major surgeries and to at least 30%-60% of normal for minor surgeries.
16185155|NCT01507870|Procedure|onlay mesh placement|prophylactic onlay mesh in patients with median laparotomy
16185156|NCT01507857|Biological|400U /0.5ml EV71 vaccine|inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
16185157|NCT01507857|Biological|0/0.5ml placebo|0/0.5ml placebo, two doses, 28 days interval
16185158|NCT01507844|Device|positive ventilation|10 minutes of increased 4,7,12 positive pressure ventilation
16185159|NCT01507831|Drug|Placebo (for alirocumab)|Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe.
16185160|NCT01507831|Drug|Alirocumab|Solution for injection, one subcutaneous injection in the abdomen, thigh, or outer area of upper arm with a pre-filled syringe.
16185161|NCT01507831|Drug|Lipid-Modifying Therapy (LMT)|Statin (rosuvastatin, simvastatin or atorvastatin) at stable dose with or without other LMT as clinically indicated.
16185162|NCT01507818|Device|Ivivi Torino II|Emits a PRF generated specific electromagnetic signal consisting of a 27.12 MHz radio frequency carrier pulse-modulated with a burst duration of 3 milliseconds repeating at 2 times per second (2Hza0>
16185163|NCT01507818|Device|Inactive Sham device|The inactive control device (Sham) identical to the Active device with the exception that a PRF signal is not delivered.
16185164|NCT01507805|Device|EA preconditioning|EA preconditioning group was treated at bilateral Neiguan(PC 6)，Lieque(LU 7)and Yunmen(LU 2)with electrical stimulation(5-30 Hz，2．34-6．24 mA，30 min)for 5 consecutive days before surgery
16185165|NCT01507805|Device|sham EA preconditioning|Patients in Sham EA preconditioning group was treated at bilateral Neiguan(PC 6)，Lieque(LU 7)and Yunmen(LU 2)without electrical stimulation(5-30 Hz，2．34-6．24 mA，30 min)for 5 consecutive days before surgery
16185166|NCT01507792|Drug|iron sulphate|1 or 2 330 mg/daily iron sulphate oral tablets
16185167|NCT01507792|Drug|antiH1-histamine, proton pump inhibitor|This is not an intervention of interest, but it is a selection criterion to define unexplained cough, as suggested by cough guidelines.
16185168|NCT01507779|Biological|IVACFLU|IVACFLU is a whole virus vaccine, collected in a linear sucrose density gradient solution using a continuous flow centrifuge Alfpa Wassmann and inactivated with formaldehyde. It was formulated to contain 15 mcg hemagglutinin (HA) of influenza A/California/07/2009(H1N1)-like virus per 0.5 mL dose and filled in single dose vials.
16185169|NCT01507779|Other|Placebo|Phosphate buffered saline (PBS), pH 7.2, in 0.5 ml single-dose vials.
16185170|NCT01507766|Drug|early enteral nutrition|The enteral nutrition was started within 48h after admission
16185171|NCT01507766|Drug|Delayed enteral nutrition|The enteral nutrition was started at the 8th day after admission
16185172|NCT01507753|Drug|Omega-3 Supplementation|The Ω3 group will receive 1000 mg Ω3 (two 500 mg capsules, each containing 350 mg EPA: 50 mg DHA; 100 other Ω3) two times daily for a total daily dose of 2000 mg Ω3 (1400 mg EPA: 200 mg DHA; 400 other Ω3). The placebo group will receive two capsules two times daily matched for odor and appearance with the active intervention.
16185451|NCT01505647|Biological|Zoster Vaccine, Live|One approximately 0.65-mL injection subcutaneously on Day 1
16185173|NCT01507753|Behavioral|Psychoeducational Psychotherapy (PEP)|Therapy sessions occur twice a week for up to 24 sessions of manualized treatment. The importance of separating symptoms from the individual is emphasized. The family is offered support, validation, and recognition for their own difficult experiences in living with the child's mood disorder. Family members are taught that patients are particularly vulnerable to stress and tension; thus, therapists work with families to reduce the level of stress and tension in their homes. Improvement of communication, problem solving and coping strategies can lead to restoration of hope for recovery and decrease family dysfunction. Goals include strengthening the parent-child bond and helping children and parents feel competent to manage depression now and in future recurrences.
16185174|NCT01507753|Other|Placebo|The placebo group will receive active monitoring (no IF-PEP) and two capsules two times daily matched for odor and appearance with the active intervention.
16185175|NCT01507740|Drug|Avastin|Dosage, duration, indications and contraindications of treatment rely on the sole responsibility of the treating physician and are not subject of the present study
16185176|NCT01507740|Drug|Suntent|Dosage, duration, indications and contraindications of treatment rely on the sole responsibility of the treating physician and are not subject of the present study
16185177|NCT01507740|Drug|Nexavar|Dosage, duration, indications and contraindications of treatment rely on the sole responsibility of the treating physician and are not subject of the present study
16185178|NCT01507727|Drug|Tolvaptan|Tablet;15mg/tab; 30mg/tab; 15/30/60mg/day for 7 days Plus conventional therapy according to each patient's underlying disease, such as CHF, hepatic cirrhosis and SIADH or others.
16185179|NCT01507727|Drug|Placebo|placebo plus conventional therapy according to each patient's underlying disease, such as CHF, hepatic cirrhosis and SIADH or others.
16185180|NCT01507714|Procedure|Preventive transobturator tension free vaginal tape|during the vaginal wall repair surgery, a TVT-O procedure will be done
16185181|NCT01507701|Drug|Clonidine|50 micrograms twice a day for 14 days; thereafter 25 microgram clonidine twice a day for 7 days; thereafter discontinuation.
16185182|NCT01507688|Behavioral|Stroke Self-Management|Stroke self-management program- Participants randomized to this program will receive 6 bi-weekly telephone sessions during the first 3 months followed by 3 monthly reinforcement telephone sessions coupled with 3 monthly group sessions during months 4-6.
16185183|NCT01507662|Behavioral|Bone Mineral Density Result Letter and Bone Health Brochure|Letter mailed to patient to include - Date of DXA, T-score, impression, 10 year major fracture risk with visual depiction of risk, basic bone health guidelines, instructions to follow-up with their healthcare provider. The brochure will include information on osteoporosis, calcium, vitamin D, medicines, exercise, tobacco and alcohol cessation and where to find more information.
16185184|NCT01507649|Behavioral|telephone-based cognitive-behavioral intervention|The intervention is based on the cognitive-behavioral approach. It consists of five, 30-minutes sessions delivered weekly from postpartum week one to week five via telephone.
16185185|NCT01507636|Other|Occupational Therapy|Occupational therapy using a special arm function training.
16185186|NCT01507636|Other|Physical therapy|Physical therapy for arm force training.
16185187|NCT01507623|Device|Capnography (Phillips MP20 monitor)|"In the intervention group the NAPS nurse observed possible hypoxia and changes in capnography curves/values during the procedure and was instructed to decrease propofol and take actions against insufficient ventilation* if etCO2 ≥ 7kPa or ≤ 2 kPa for ≥ 1 minute, if respiratory frequency ≤ 8 or a loss of curve shape was registered.
~*Suction, increase oxygen supply, tongue holder or nasal airway, bag-mask ventilation,paged anaesthesia Discontinued procedures"
16185188|NCT01507610|Drug|Sumatriptan|To compare the single-dose pharmacokinetics (PK) and relative bioavailability of intranasal administration of 20 mg OPTINOSE SUMATRIPTAN with 20 mg IMITREX® (sumatriptan) Nasal Spray, 100 mg IMITREX® (sumatriptan) Oral Tablet, and 6 mg IMITREX® (sumatriptan) Subcutaneous Injection, in healthy subjects.
16185189|NCT01507597|Drug|Native human Glucagon-like Peptide-1 ( GLP-1(7-36))|"Continuous iv. infusion of the native gut hormone GLP-1 (0.2 pmol/kg/min) for 210 minutes.
~Combined with a step wise glucose clamp using 20% w/w glucose iv. infusion reaching plasma glucose value of 15 mM starting at fasting plasma glucose (30 min per step)"
16185190|NCT01507597|Drug|NaCl|Continuous iv. saline infusion (NaCl Isotonic) for 210 minutes. Combined with a step wise glucose clamp using 20% w/w glucose iv. infusion reaching plasma glucose value of 15 mM starting at fasting plasma glucose (30 min per step)
16185191|NCT01507597|Drug|Native human Glucagon-like Peptide-1 ( GLP-1(7-36))|"Continuous iv. infusion of the native gut hormone GLP-1 (0.4 pmol/kg/min) for 210 minutes.
~Combined with a step wise glucose clamp using 20% w/w glucose iv. infusion reaching plasma glucose value of 15 mM starting at fasting plasma glucose (30 min per step)"
16185192|NCT01507597|Drug|Native human Glucagon-like Peptide-1 ( GLP-1(7-36))|"Continuous iv. infusion of the native gut hormone GLP-1 (0.8 pmol/kg/min) for 210 minutes.
~Combined with a step wise glucose clamp using 20% w/w glucose iv. infusion reaching plasma glucose value of 15 mM starting at fasting plasma glucose (30 min per step)"
16185193|NCT01507584|Device|SENSIMED Triggerfish|Comparison of fluctuation of Intraocular pressures with different class of drugs
16185194|NCT01507571|Other|Dignity Therapy|"Dignity Therapy is a brief psychotherapeutic intervention consisting of:
~a tape-recorded session with the patient using the DT question protocol
~Transcription of the interview, which is then edited
~A session where the edited transcript is returned to the patient who can give it to family members or friends.
~If needed, one or more sessions are added. Dt allows the patient to give voice to the matters of importance concerning himself and his loved ones. Its purpose is to enhance sense of meaning, purpose and worth. It also gives the opportunity to leave something behind to be remembered by."
16185195|NCT01507558|Procedure|Administration of dexamethasone to SFA/popliteal adventitia|Following a balloon angioplasty or atherectomy of a stenotic TASC II A, B, or C lesion in the superficial femoral or popliteal artery, a Bullfrog Micro-Infusion Catheter will be used to infuse 0.96 mg dexamethasone per cm arterial lesion.
16185196|NCT01507545|Drug|MORAb-004|MORAb-004 8mg IV per kg once a week
16185197|NCT01507545|Drug|Placebo|Placebo - normal saline IV once a week
16185198|NCT01507532|Other|pharmacokinetic monitoring|pharmacokinetic monitoring
16185199|NCT01507519|Device|Sirolimus Eluting Coronary Stent System (Biomime)|Coronary Artey PTCA
16185630|NCT01504373|Device|Neurally Adjusted Ventilatory Assist (NAVA)|Subjects will be placed in the NAVA mode of ventilation.
16185200|NCT01507506|Radiation|Radiotherapy|"Conventional arm: 3D conformational radiotherapy (arm A): 60 Gy per fractions of 2 Gy in 30 sessions on the PTV1 (contrast enhancement + 2 cm) with a linear accelerator equipped with a portal imaging.
~+
~Chemotherapy (Drug) :treatment should be combined with temozolomide during and after radiotherapy in a conventional treatment Stupp (Stupp et al. 2005), ie :
~during radiotherapy : Temozolomide 75 mg/m2/day by oral route every day,
~post radiotherapy : 6 cycles of Temozolomide oral route : 150 mg/m2/day from D1 to D5 for the 1st cycle followed by 200 mg/m2/day from D28 to D32."
16185201|NCT01507506|Radiation|Experimental arm|"Conformational radiotherapy with simultaneous integrated boost by intensity modulation (Arm B): 60 Gy per fraction of 2 Gy in 30 sessions on the PTV1 (contrast enhancement + 2 cm) with concomitant daily superimposed boost on spectroscopic active region (PTV2) corresponding to the ratio Cho / NAA> 2 + 0.7 mm + contrast enhancement + 3mm. The PTV2 will receive a daily dose of 2.4 Gy for a cumulative dose of 72 Gy Only irradiation with simultaneous integrated boost are allowed
~+
~Chemotherapy (Drug) :treatment should be combined with temozolomide during and after radiotherapy in a conventional treatment Stupp (Stupp et al. 2005), ie :
~during radiotherapy : Temozolomide 75 mg/m2/day by oral route every day,
~post radiotherapy : 6 cycles of Temozolomide oral route : 150 mg/m2/day from D1 to D5 for the 1st cycle followed by 200 mg/m2/day from D28 to D32."
16185203|NCT01507467|Radiation|Accl. RT|Accelerated Radiotherapy: Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week
16185204|NCT01507467|Radiation|Accl. radiotherapy + Nimorazole|Radiation: Radiotherapy 66-70 Gy, 2Gy/fx, 6fx/week plus Nimorazole (tablets or powder) 1.2 g/m2 body surface in connection with the first daily radiation treatments
16185205|NCT01507454|Drug|estradiol, 25 mcg|Vaginal tablets for 6-12 weeks according to product labelling
16185206|NCT01507441|Genetic|gene mapping|
16185207|NCT01507441|Genetic|microarray analysis|
16185208|NCT01507441|Genetic|mutation analysis|
16185209|NCT01507441|Genetic|nucleic acid sequencing|
16185210|NCT01507441|Other|laboratory biomarker analysis|
16185211|NCT01507428|Drug|18F-Fluoromisonidazole|Undergo FMISO PET/CT (Correlative studies)
16185212|NCT01507428|Drug|Carboplatin|Given IV
16185213|NCT01507428|Procedure|Computed Tomography|Undergo FDG PET/CT
16185214|NCT01507428|Procedure|Computed Tomography|Undergo FMISO PET/CT (Correlative studies)
16185215|NCT01507428|Radiation|External Beam Radiation Therapy|Undergo radiotherapy
16185216|NCT01507428|Drug|Fludeoxyglucose F-18|Undergo FDG PET/CT
16185217|NCT01507428|Radiation|Image-Guided Adaptive Radiation Therapy|Undergo individualized adaptive radiotherapy
16185218|NCT01507428|Other|Laboratory Biomarker Analysis|Correlative studies
16185219|NCT01507428|Drug|Paclitaxel|Given IV
16185220|NCT01507428|Procedure|Positron Emission Tomography|Undergo FDG PET/CT
16185221|NCT01507428|Procedure|Positron Emission Tomography|Undergo FMISO PET/CT (Correlative studies)
16185222|NCT01507402|Drug|REGN1033(SAR391786)|Administration method A
16185223|NCT01507402|Drug|REGN1033(SAR391786)|Administration method B
16185224|NCT01507402|Drug|Placebo|(inactive substance)
16185225|NCT01507389|Drug|liraglutide|Single dose of 0.75 mg injected subcutaneously (under the skin)
16185226|NCT01507376|Drug|recombinant hCG|recombinant hCG(250 µg Ovitrell)
16185227|NCT01507376|Drug|recombinant hCG|recombinant hCG(500 µg Ovitrell)
16185228|NCT01507376|Drug|urinary hCG|10,000 IU urinary hCG
16185229|NCT01507363|Drug|Gabapentin|Tables with Gabapentin (1300 mg/ day) for 7 days, starting on the day of surgery
16185230|NCT01507363|Drug|Gabapentin|Tables with Gabapentin (900 mg/day) for 7 days, starting on the day of surgery
16185231|NCT01507363|Drug|Placebo|Placebo tablets for 7 days, starting on the day of surgery
16185232|NCT01507337|Drug|liraglutide|A single dose of 1 mg administered subcutaneously (under the skin)
16185233|NCT01507311|Drug|liraglutide|A single dose injected subcutaneously (under the skin)
16185234|NCT01507311|Drug|placebo|A single dose injected subcutaneously (under the skin)
16185235|NCT01507285|Drug|liraglutide|Initial single dose followed by subsequent multiple s.c. (under the skin) doses on several dose levels (1.25, 5, 7.5, 10 and 12.5 mcg/kg). Each subject will be allocated to one dose level only
16185236|NCT01507285|Drug|placebo|Initial single dose followed by subsequent multiple s.c. (under the skin) doses
16185237|NCT01507272|Drug|liraglutide|Administered as 5 single s.c. (under the skin) doses - 1.25, 2.5, 5, 10 and 20 mcg/kg once daily - in ascending order
16185238|NCT01507272|Drug|liraglutide|Subjects receiving the dose level 5 mcg/kg s.c. will in addition receive, after a wash-out of at least 7 days, a single i.v. (into the vein) dose of 5 mcg/kg
16185239|NCT01507272|Drug|placebo|Administered s.c. After a wash-out of at least 7 days, a single i.v. (into the vein) dose is administered
16185240|NCT01507272|Drug|placebo|Administered as 5 single s.c. (under the skin) doses - 1.25, 2.5, 5, 10 and 20 mcg/kg once daily - in ascending order
16185241|NCT01507259|Other|cocoa|70% versus 34%
16185242|NCT01507246|Drug|IV morphine sulfate|Patients in this group will receive IV morphine sulfate via PCA pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the PACU or immediately upon transfer to the floor if the stay in the PACU is less than one hour.
16185243|NCT01507246|Drug|EXPAREL (bupivacaine liposome injectable suspension)|"Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
~All patients will be offered rescue analgesia, as needed."
16185244|NCT01507233|Drug|IV morphine sulfate|Patients in this group will receive IV morphine sulfate via patient-controlled analgesia (PCA) pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to the floor if the stay in the PACU is less than 1 hour.
16186007|NCT01501591|Other|Placebo|Matching placebo once on two different days, 72 hours apart.
16185245|NCT01507233|Drug|EXPAREL (bupivacaine liposome injectable suspension)|"Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac, a non-steroidal anti-inflammatory drug (NSAID), may be substituted per the site's standard of care.
~All patients will be offered rescue analgesia, as needed."
16185246|NCT01507220|Drug|morphine sulfate|Patients in this group will receive IV morphine sulfate (or Sponsor-approved equivalent) via patient-controlled analgesia (PCA) pump, as needed. The PCA pump will be set up postsurgically as soon as possible and prior to the patient leaving the post-anesthesia care unit (PACU) or immediately upon transfer to the floor if the stay in the PACU is less than 1 hour. All morphine sulfate (Group 1) patients will receive the same opioid in their PCA pump.
16185247|NCT01507220|Drug|bupivacaine liposome extended-release injectable suspension|"Patients in this group will receive 266 mg EXPAREL diluted with preservative free 0.9% normal saline to a total volume of 30 cc and administered via wound infiltration prior to wound closure. When not contraindicated, 30 mg IV ketorolac will be given at the end of surgery. If not indicated, an IV non-steroidal anti-inflammatory drug (NSAID) may be substituted per the site's standard of care.
~All patients will be offered rescue analgesia, as needed."
16185248|NCT01507207|Procedure|Injection laryngoplasty|Patients will undergo a direct microlaryngoscopy in the operating room for diagnostic purposes. In patients in whom laryngeal cleft is diagnosed, injection laryngoplasty will be carried out using sodium carboxymethylcellulose aqueous gel (commercial name Radiesse) injection material.
16185249|NCT01507194|Drug|Ondansetron|Single IV dose
16185250|NCT01507194|Drug|Vestipitant|Single IV dose
16185251|NCT01507181|Drug|Ketamine|single dose IV ketamine, .5mg/kg infused over 40 minutes
16185252|NCT01507181|Drug|Midazolam|single dose IV midazolam, .45mg/kg infused over 40 minutes
16185253|NCT01507168|Drug|Placebo|iv Days 1 and 8, and every 2 weeks thereafter
16185254|NCT01507168|Drug|GC33|1600 mg iv Day 1 and 8, and every 2 weeks thereafter
16185255|NCT01507155|Device|Genecept Assay|Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders
16185256|NCT01507116|Other|No treatment given|Three separate survey questionnaires, one for each of the three diabetes groups. Each questionnaire is composed of multiple items including pre-coded (multiple choice) questions, dichotomous (yes/no) questions and rating scales.
16185257|NCT01507103|Biological|Tecemotide (L-BLP25)|Subjects will receive 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8, which will be administered concomitantly with the chemoradiotherapy, followed by a 9th subcutaneous injection 7 to 11 days prior to surgery.
16185258|NCT01507103|Drug|cyclophosphamide (CPA)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of CPA will be given 3 days before the first tecemotide (L-BLP25) administration.
16185259|NCT01507103|Other|Chemoradiotherapy|Radiotherapy of 45-52 grays (Gy) will be applied 5 times per week, over a minimum period of 5 weeks. Capecitabine at a dose of 825 mg/m^2, twice daily or equivalent dose of 5-fluorouracil (5-FU) will be given orally, starting at the first day of radiotherapy and given 5 to 7 days per week during the time of radiotherapy.
16185260|NCT01507090|Device|Mercy TAPE|2D Mercy TAPE and 3D Mercy TAPE
16185261|NCT01507077|Drug|ZGN-440|Subjects will receive ZGN-440 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.
16185262|NCT01507077|Drug|ZGN-440 sterile diluent|Subjects will receive placebo twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.
16185263|NCT01507064|Drug|Sorafenib|tablets 200mg dosage: 400mg bid duration: 4 weeks
16185264|NCT01507064|Procedure|laser ablation (LA)|"For LA, we use a commercially available system (Echolaser XVG system, Esaote El.En., Florence, Italy) and four optical fibers,inserted into the tumor through four 21-gauge needles. The tips of the needles will be positioned at a distance of 15mm from each other.
~When, after LA treatments, CT or MRI findings show a residual nodule activity of 10% or less, percutaneous ethanol injection may be done. If the residual activity is of 50% or more transarterial chemoembolization may be used."
16185265|NCT01507051|Drug|Warfarin (Coumadin)|Days -6 and -5: 10 mg warfarin (Coumadin) once daily, dosage lower if the INR is already high on day -5; Days -4 to -1 (could be prolonged by two days): 2.5, 5, 10, 12.5 or 15 mg warfarin (Coumadin) once daily, dosage depending on INR
16185266|NCT01507051|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Days 0 to 3: 20 mg rivaroxaban once daily
16185267|NCT01507051|Drug|Placebo|Days 0 to 3: 1 tablet placebo, identical to active tablet
16185268|NCT01507051|Drug|Vitamin K (Konakion)|Day 5: 10 mg vitamin K (Konakion) once daily
16185269|NCT01507038|Drug|YH14617|1mg once weekly
16185270|NCT01507038|Drug|YH14617|1.6mg once weekly
16185271|NCT01507038|Drug|YH14617|2mg once biweekly
16185272|NCT01507038|Drug|Placebo|Once weekly
16185273|NCT01507012|Dietary Supplement|Berry Polyphenols|
16185274|NCT01507012|Dietary Supplement|Placebo|Placebo control containing sugar and artificial flavouring.
16185275|NCT01506999|Biological|MULTIGENE SCREENING FOR SINGLE SNPS|DNA will be genotyped employing a multicolour assay system for SNPs based on TaqMan MGB (Minor Groove Binder) probes.
16185276|NCT01506986|Drug|Lansoprazole 30mg, Clarithromycin 500mg, Metronidazole 400mg|All three medications will be taken orally, twice daily, for seven days.
16185277|NCT01506986|Drug|Placebo lansoprazole 30mg, clarithromycin 500mg, metronidazole 400mg|Medication to be taken orally, twice a day, for seven days.
16185278|NCT01506973|Drug|Hydroxychloroquine (HCQ)|
16185279|NCT01506973|Drug|Gemcitabine|
16185280|NCT01506973|Drug|Abraxane|
16185281|NCT01506960|Device|InfraReDx Lipiscan IVUS|Near Infrared Spectroscopy/Intravascular Ultrasound will be performed following OCT imaging.
16185282|NCT01506947|Drug|Paricalcitol|"Paricalcitol was administered by intravenous bolus. The initial dose was calculated according to the following formula:
~[Paricalcitol (µg) = iPTH (pg/mL) / 80]. Subsequent doses were determined based on iPTH, calcium and phosphorus levels."
16185283|NCT01506947|Drug|Darbepoetin alfa|Routine darbepoetin alfa use was allowed when transferrin saturation (TSAT) was ≥ 20% and ferritin ≥ 200 μg/L, and hemoglobin level < 11.5 g/dL. The initial dose was 0.25 to 0.75 µg/kg/week, and the maintenance dose was 0.13 to 0.35 µg/kg/week. Target hemoglobin level was between 10 to 11.5 g/dL.
16185284|NCT01506934|Drug|linifanib|"Single Dose on Day 1 of Periods 1, 2 and 3 (Bioavailability Portion)
~Single Dose on Day 1 of Periods 1 and 2 (Food Effect Portion)"
16185285|NCT01506921|Drug|Racemic ketamine|0.6 mg/kg
16185286|NCT01506921|Drug|S-ketamine|0.3 mg/kg
16185287|NCT01506908|Drug|oral nicotine|oral nicotine replacement product
16185288|NCT01506908|Drug|Placebo|no active
16185289|NCT01506895|Drug|darapladib|Experimental compound 160 mg dose
16185290|NCT01506895|Drug|placebo|Placebo to match
16185291|NCT01506882|Drug|Levetiracetam (LEV)|"Active Substance: Levetiracetam
~Pharmaceutical Form: Film-coated tablet
~Concentration: LEV 250 mg, LEV 500 mg
~Frequency: Twice daily
~Route of Administration: Oral use"
16185292|NCT01506856|Drug|Paclitaxel(intravenous) + Carboplatin(intravenous)|Paclitaxel(intravenous) + Carboplatin(intravenous) Paclitaxel : 80mg/m2, IV infusion, Day1, 8, and 15 Carboplatin: AUC=6.0, IV infusion, Day1 A total of 6 to 8 cycles will be repeated.
16185293|NCT01506856|Drug|Paclitaxel(intravenous) + Carboplatin(intraperitoneal)|Paclitaxel(intravenous) + Carboplatin(intraperitoneal) Paclitaxel : 80mg/m2, IV infusion, Day1, 8, and 15 Carboplatin: AUC=6.0, IP injection, Day1 A total of 6 to 8 cycles will be repeated.
16185294|NCT01506843|Biological|Mite, Mite and Bacterial or Placebo|All treatments were given by sublingual route according to schedule of EAACI, with some modification. Patients received up-dosing sublingual drops once a day, reaching in approximately 3 months a monthly maintenance dose of 36 μg of Der p 1 given three times a week in alternate days for mite, mite and bacterial allergen extract, and no Der p 1 and no bacterial components in the placebo group. Doses were delivered by using vials equipped with a metered-dose dropper, and subjects were instructed to hold the solution under the tongue for 2 min and not to eat or drink for 60 min after the dose. Subjects self-administered the treatment at home. Adjustments in the schedule were made on an individual basis according to standard guidelines for specific immunotherapy
16185295|NCT01506830|Procedure|Relative isolation with cotton rolls|Cotton roll group: Moisture control was provided using a labial retractor, cotton rolls and gingival retraction cord placed into the gingival sulcus
16185296|NCT01506830|Procedure|Absolute isolation with rubber dam|Rubber dam group: Moisture control was provided by a rubber dam and a gingival retraction clamp placed in the cervical area of the tooth.
16185297|NCT01506817|Procedure|Dynamic contrast-enhanced MRI of the hands|The hand and wrist will be examined in a 3T Siemens Verio® MR scanner with the patients and normal controls supine and the hand along the side of the body (3T Verio) using a semiflex 15 channel body coil. Total imaging time varies between 30-35 minutes.
16185298|NCT01506804|Other|methylprednisolone|Steroid injection X 2 and 10 weeks exercise program of painful shoulder vs exercise program of contralateral shoulder
16185299|NCT01506791|Drug|Desloratadine and pseudoephedrine|Desloratadine and pseudoephedrine 5/240 mg
16185300|NCT01506778|Device|Tenaculum|Single tooth tenaculum are use to the cervix for steady the cervix, straighten the cervicouterine angle and provide countertraction. Most of gynecological office procedure such as endometrial sampling procedure, hysterosalpingography, hysteroscopy, insertion of contraceptive intrauterine device, difficult intrauterine insemination or embryo transfer procedures often require the application of a tenaculum.
16185301|NCT01506765|Drug|N-Acetyl-Cysteine (NAC)|Once included, the patients will be randomly placed in two groups: one group (1) will receive 2 g/day of NAC (2caps of 0.5g twice a day) and the other group (2) a placebo, for a duration of 8 weeks. At the end of the 8 weeks, group (2) will receive NAC and (1) the placebo for another 8 weeks
16185302|NCT01506752|Drug|Donepezil Hydrochloride|improved orally disintegrating E2020 10 mg tablet without water.
16185303|NCT01506752|Drug|Donepezil Hydrochloride|current orally disintegrating E2020 10 mg tablet without water.
16185304|NCT01506752|Drug|Donepezil Hydrochloride|improved orally disintegrating E2020 10 mg tablet with water.
16185305|NCT01506752|Drug|Donepezil Hydrochloride|current orally disintegrating E2020 10 mg tablet with water
16185306|NCT01506739|Drug|Donepezil Hydrochloride|Drug E2020 film-coated tablet: E2020 film-coated tablet (5mg) orally administered in a single dose with 200 mL water.
16185307|NCT01506739|Drug|Donepezil Hydrochloride|Drug E2020 dry syrup 1% form (suspended): E2020 dry syrup 1% (0.5 g) will be orally administered in a single dose after suspended in 20 ml water.
16185308|NCT01506739|Drug|Donepezil Hydrochloride|Drug E2020 dry syrup 1% form: E2020 dry syrup 1% (0.5 g) will be orally administered in a single dose with 200 mL water.
16185309|NCT01506726|Drug|Salsalate|Salsalate 750mg tablet 1 pill bid for one month followed by Salsalate 750mg tablets 2 pills (1500mg) twice a day for a further 5 months (total duration of treatment will be 6 months)
16185310|NCT01506726|Drug|Placebo|Placebo tablet - one pill twice daily for one month, followed by 2 pills twice daily for a further 5 months. Total duration of treatment is 6 months
16185311|NCT01506713|Drug|Clopidogrel|Clopidogrel Tablets 75 mg
16185312|NCT01506700|Device|Optical Coherence Tomography|Optical coherence tomography will be used to image tissue structure on excised and in vivo specimens.
16185313|NCT01506687|Behavioral|Health counselling by nurse navigator|Information on colorectal cancer and screening, assistance in selection of screening option and obtaining kit or colonoscopy referral
16185314|NCT01506687|Behavioral|Usual primary care counselling|Usual care health counselling on colorectal cancer and screening options
16185315|NCT01506661|Drug|Zostavax (varicella zoster virus) vaccine|Standard vaccination protocol for Zostavax will be utilized. 0.65 ml (19,400 plaque forming units) Zostavax will be administered subcutaneously once at the baseline visit
16185316|NCT01506635|Drug|Timolol|
16185317|NCT01506635|Drug|Placebo|artificial tear twice a day
16185318|NCT01506622|Drug|Administration of propofol|Propofol 1 mg/kg will be administered to propofol group at the end of anesthesia.
16185319|NCT01506622|Drug|Administration of fentanyl|Fentanyl 1 mcg/kg will be administered to fentanyl group at the end of anesthesia.
16185320|NCT01506622|Drug|Administration of saline|Saline will be administered to control group at the end of anesthesia.
16185326|NCT01506596|Drug|pazopanib|Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle. Study treatment may continue until disease progression or unacceptable toxicity.
16185327|NCT01506570|Biological|TetraVax-DV Vaccine - Admixture TV003|One SC injection at Day 0 and Day 180 of the TetraVax-DV Vaccine, Admixture TV003 (10^3 plaque-forming unit [PFU] of rDEN1Δ30, 10^3 PFU of rDEN2/4Δ30[ME], 10^3 PFU of rDEN3Δ30/31-7164, and 10^3 PFU of rDEN4Δ30)
16185328|NCT01506570|Biological|TetraVax-DV Vaccine - Admixture TV005|One SC injection at Day 0 and Day 180 of the TetraVax-DV Vaccine, Admixture TV005 (10^3 PFU of rDEN1Δ30, 10^4 PFU of rDEN2/4Δ30[ME], 10^3 PFU of rDEN3Δ30/31-7164, and 10^3 PFU of rDEN4Δ30)
16185329|NCT01506570|Biological|Placebo|One SC injection at Day 0 and Day 180 of placebo
16185330|NCT01506557|Dietary Supplement|cholecalciferol|dose 800 IU/day for 6 month
16185331|NCT01506557|Dietary Supplement|placebo|oil capsules
16185332|NCT01506544|Drug|Hydroxyurea|20mg/kg of Hydroxyurea or the patient's standard daily dose
16185333|NCT01506531|Procedure|silo for gastroschisis|silo placed around abdominal contents in gastroschisis patients
16185334|NCT01506531|Procedure|Primary closure of gastroschisis|Primary closure of gastroschisis, if possible
16185335|NCT01506505|Drug|Cardiovascular Agents|Acetylsalicylic acid 75mg, simvastatin 40mg, lisinopril 10mg, hydrochlorthiazide 12.5mg in individual agents or a combination pill
16185336|NCT01506492|Behavioral|CALM|Patients assigned to the intervention arm will receive 3-6 CALM therapy sessions over 3-6 months delivered by a trained therapist at our center.
16185337|NCT01506479|Behavioral|Moderate Exercise|Endurance exercise at 60 - 65% heart rate (HR) max,4x/wk for 6 months.
16185338|NCT01506479|Behavioral|Vigorous Exercise|Endurance exercise at 80-85% HR max, 4x/wk for 6 months.
16185339|NCT01506479|Behavioral|No Intervention|No-exercise control (i.e., usual care);
16185340|NCT01506466|Other|blood test/ additional measurement|blood test (hormonal, inflammatory, lipid and growth factors); body composition measurements; energy balance evaluation
16185341|NCT01506453|Drug|gabapentin|Participants randomized to the active treatment arm will receive gabapentin 20mg/kg/day PO divided into 3 doses and rounded to the nearest 100 mg for capsules and 10 mg for liquid preparation.
16185342|NCT01506453|Drug|placebo|Participants randomized to the placebo treatment arm will receive look-alike capsules or liquid in a respective capsule size or liquid measure equivalent to the active treatment arm, but which contain no active treatment.
16185343|NCT01506440|Procedure|cognitive assessment|Given cognitive assessments
16185344|NCT01506440|Procedure|quality-of-life assessment|Ancillary studies
16185345|NCT01506427|Radiation|[F-18] HX4|A single dose of 10 mCi, injected intravenously.
16185346|NCT01506414|Drug|rhTPO in combination with Rituximab|Rituximab was given intravenously at a dose of 100 mg weekly for 4 consecutive weeks (Day 1, 8, 15, 22). Rh-TPO (TPIAOTM, a product of Sunshine Pharmaceutical Co Ltd, China, approved by China State Food and Drug Administration) was given subcutaneously at a dose of 1.0 μg/kg（300u/kg）for 14 days (Day 1-14).
16185347|NCT01506401|Device|SensorMedics 3100B High Frequency Oscillatory Ventilator|High Frequency Oscillation
16185348|NCT01506401|Procedure|Lung Protective Ventilation|Tidal Volume 6ml/kg; plateau pressure < or = 35cmH20; Prescribed PEEP/FiO2 chart
16185349|NCT01506388|Device|foley catheter|foley 14 catheter intracervical plus vaginal IMN 40 mg evry 6 hours
16185350|NCT01506388|Drug|Misoprostol|misoprostol 50 Ug , vaginally every 4-6 hours
16185351|NCT01506388|Drug|Vaginal IMN|IMN vaginal 40 mg every 4-6 hours
16185352|NCT01506375|Biological|gpASIT+TM|1 subcutaneous injection every 7 days during 29 days
16185353|NCT01506375|Biological|gpASIT+TM + adjuvant|1 subcutaneous injection every 7 days during 29 days
16185354|NCT01506362|Drug|BL-7040|"BL-7040 is an orally available new chemical entity for the treatment of IBD. BL-7040 is a synthetic oligonucleotide with dual activity on both the nervous and immune systems.
~Study duration can last up to 8 weeks, including up to 9 days in the screening period, up to 5 weeks of treatment with BL-7040, and up to 2 weeks for follow up.
~BL-7040 12 mg QD for 19-21 days followed by BL-7040 40 mg QD for 14 days."
16185355|NCT01506349|Dietary Supplement|gluten|4 grams of gluten.
16185356|NCT01506349|Dietary Supplement|Placebo|
16185357|NCT01506336|Drug|masitinib|masitinib 12 mg/kg/day
16185358|NCT01506336|Drug|sunitinib|sunitinib 50 mg/day
16185359|NCT01506323|Behavioral|Mantram Repetition Program (MRP)|The MRP teaches three portable, mindfulness strategies to train attention and manage symptoms: 1) Mantram (sacred word) Repetition, 2) Slowing Down, and 3) One-Pointed Attention. These tools are presented as working together synergistically and cumulatively, over time, to interrupt negative thoughts, behaviors, and emotional states such as anger, rage, irritability and impatience. Participants choose their own words or phrases and are encouraged to practice repeating a mantram at any time or place. In this study, MRP is delivered individually in eight weekly, 1-hour sessions, using a standardized manual, instructor guide, and homework assignments for experiential learning.
16185360|NCT01506323|Behavioral|Present Centered Therapy (PCT)|The PCT is a form of individual therapy that is problem-oriented to improve current coping. It avoids details of traumatic experiences. In this study, it is delivered individually in 8 weekly, 1 hour sessions to serve as an active, attention control arm. Sessions are unstructured and managed so that there is some engagement of the participant's emotional concerns with an emphasis on strengths and process encouragement rather than skills training. Three components of PCT include 1) developing a therapeutic relationship for social support, 2) focusing on current problems and problem solving, 3) and setting goals.
16185361|NCT01506310|Behavioral|Behavioral therapy|General written dietary recommendations (about cooking, lowering sugar intake, reducing salt intake, reducing beverages and food with added sugars) and written options for dining out. A brief written guide on behavior change.
16185362|NCT01506310|Other|Exercise|The exercise groups will be advised to walk at least 20-minute a day.
16185363|NCT01506310|Other|Behavioral therapy and exercise|"General written dietary recommendations (about cooking, lowering fat intake, reducing salt intake, reducing beverages and food with added sugars) and written options for dining out.
~Written recommendations for physical activity A brief written guide on behavior change"
16185796|NCT01503164|Behavioral|LifeStyle Counseling|Subjects randomized to the lifestyle (and nutritional) counseling arm will be given advice on a balanced dietary and exercise plan.
16185364|NCT01506284|Procedure|Forced oscillatory technique (FOT) and laser interferometry (LIR).|"FOT: The stimulating signal is generated by an A/D-D/A board and amplified by a power amplifier that drives a loudspeaker the output of which is connected to inspiratory line of the ventilator. Pressure and flow are measured at the inlet of the endotracheal tube by a piezoresistive pressure transducer and a mesh-type heated pneumotachograph coupled with a differential pressure transducer.
~LIR: The scanner unit is made by three laser interferometers, the beams of which are deflected on the chest wall surface by a mirror moved by a stepper motor triggered on the respiratory pattern of patient."
16185365|NCT01506271|Drug|Relebactam 250 mg|Relebactam 250 mg IV every 6 hours for a minimum of 96 hours
16185366|NCT01506271|Drug|Relebactam 125 mg|Relebactam 125 mg IV every 6 hours for a minimum of 96 hours
16185367|NCT01506271|Drug|Imipenem/cilastatin|A 500 mg dose of imipenem/cilastatin will be administered IV in an open-label fashion once every 6 hours with each dose infused over a 30-minute interval.
16185368|NCT01506271|Drug|Matching placebo to relebactam|Placebo-matching infusion of IV normal saline (0.9%) once every 6 hours.
16185369|NCT01506258|Procedure|Application of Stem Cells|IV infusion of autologous stem cells within the first 48 hours after birth.
16185370|NCT01506258|Procedure|Observation|Control group of patients that meet the inclusion criteria but that do not wish to have the intervention.
16185371|NCT01506245|Behavioral|Family-based behavioral therapy|The intervention consist of a 6-month family-based behavioural therapy either in group (1 session/week, with a dietician and a psychologist) or in individual setting (with a paediatrician or a dietician in alternance 1x/month). Both therapies include exercise training twice per week (60 minutes each). Parents, or at at least the mother, must participate to the behavioral treatment.
16185372|NCT01506219|Procedure|Geriatrician-performed CGC|Individual disease management and coping was provided using the holistic approach during the face-to-face counselling, where the actual problems, expectations and aims were defined in dialogue with the patient and/or relatives. Afterwards, targeted problem solving with focus on the potentially reversible causes of functional deterioration was established. Finally, medication adjustment was carried out with particular attention to drugs which may lead to iatrogenic functional deterioration, delirium, falls, and malnutrition. Furthermore, the intervention included intravenous antibiotics or blood transfusions (if indicated) conducted by the geriatrician at the rehabilitation units.
16185373|NCT01506193|Biological|PriorixTetra™|One dose administered subcutaneously
16185374|NCT01506193|Biological|Meningitec|One dose administered intramuscularly
16185375|NCT01506167|Drug|Bevacizumab|Bevacizumab was administered as part of standard first-line treatment
16185376|NCT01506167|Drug|Capecitabine/Oxaliplatin|Capecitabine/oxaliplatin were administered along with bevacizumab as part of standard first-line treatment
16185377|NCT01506167|Drug|Fluorouracil/Folinic Acid/Oxaliplatin|Fluorouracil/folinic acid/oxaliplatin were administered along with bevacizumab as part of standard first-line treatment
16185378|NCT01506167|Drug|Capecitabine|Capecitabine was administered along with bevacizumab as part of standard first-line treatment
16185379|NCT01506167|Drug|Fluorouracil/Folinic Acid/Irinotecan|Fluorouracil/folinic acid/irinotecan were administered along with bevacizumab as part of standard first-line treatment
16185380|NCT01506167|Drug|Fluorouracil +/- Folinic Acid|Fluorouracil +/- folinic acid were administered along with bevacizumab as part of standard first-line treatment
16185381|NCT01506154|Drug|MRX-7EAT|Once daily application of a patch for 14 days
16185382|NCT01506141|Drug|Idursulfase-IT|Participants will receive Idursulfase-IT once monthly at the dose used in study HGT-HIT-045 via intrathecal drug delivery device (IDDD).
16185383|NCT01506141|Drug|Elaprase|Participants will receive weekly IV infusions of commercially available Elaprase.
16185384|NCT01506128|Other|Collecting a Pad used at the first menstrual period after enrollment|Collecting a Pad used at the first menstrual period after enrollment
16185385|NCT01506115|Drug|Photofrin|Photodynamic therapy: Intravenous Photofrin at a dose of 2 mg/kg body weight, 48 hours before photoactivation by intraluminal light illumination
16185386|NCT01506102|Device|Thromboelastography|Thromboelastography during labor and after delivery
16185387|NCT01506089|Other|36 degrees Celsius|Embryos in this group will be cultured in incubators set to 36 degrees Celsius.
16185388|NCT01506076|Drug|Levocetirizine DiHCl|Levocetirizine DiHCl Tablets 5 mg
16185389|NCT01506063|Drug|Levocetirizine DiHCl|Levocetirizine DiHCl Tablets 5 mg
16185390|NCT01506050|Drug|Desloratadine|Desloratadine ODT 5 mg
16185391|NCT01506037|Drug|Desloratadine|Desloratadine ODT 5 mg
16185392|NCT01506024|Procedure|Total hip arthroplasty direct lateral approach|
16185393|NCT01506024|Procedure|Total hip arthroplasty posterior approach|
16185394|NCT01506024|Procedure|Total hip arthroplasty, anterior approach|
16185395|NCT01506011|Drug|Amlodipine Besylate/Benazepril HCl|Amlodipine Besylate/Benazepril HCl 10 mg/40 mg capsules
16185396|NCT01505998|Drug|Amlodipine Besylate/Benazepril HCl|Amlodipine Besylate/Benazepril HCl 10 mg/40 mg capsules
16185397|NCT01505985|Dietary Supplement|Oral nutritional Supplement|Specialized nutritional supplement for seniors
16185398|NCT01505985|Dietary Supplement|Placebo|placebo product with no specific nutrients
16185399|NCT01505972|Other|Six and three time schedule|Invitation letter sent 6 weeks and reminder 3 weeks before a pre-specified screening colonoscopy appointment date.
16185400|NCT01505972|Other|Four and two time schedule|Invitation letter and reminder sent 4 and 2 weeks before pre-specified screening colonoscopy appointment date.
16185401|NCT01505959|Device|CPAP treatment|Usual CPAP treatment
16185402|NCT01505959|Device|CPAP treatment|CPAP treatment with telemedicine system
16185403|NCT01505946|Other|TGA (Thrombin generation Assay)|"TGA will be performed on plasma in order to evaluate differences in the ability to stimulate the thrombin generation among the different class of FVIII concentrates and possibly identify the most effective. The TGA will be quarterly repeated in order to verify if it is also adequate to check the therapy effectiveness during the study period"
16185452|NCT01505634|Drug|Relebactam 250 mg|Participants randomized to receive relebactam 250 mg will be administered a 250 mg dose of relebactam IV in a blinded fashion once every 6 hours with each dose infused over a 30-minute interval.
16186008|NCT01501591|Drug|hydroxyzine/placebo|25 mg hydroxyzine or placebo once on two different days, 72 hours apart
16185404|NCT01505933|Drug|Dexmedetomidine|"Administer dexmedetomidine at 1mcg/kg over 10min followed by an infusion of dexmedetomidine at 1mcg/kg/hr and image the upper airway.
~After the initial set of images is obtained, the depth of anesthesia will be increased by administering a bolus dose of dexmedetomidine 2mcg/kg followed by increase in the infusion rate to 3mcg/kg/hr. Upper airway images will be repeated 5mins after increasing infusion Image acquisitions will be repeated approximately 5 min after the increase in infusion rate."
16185405|NCT01505933|Drug|propofol|"Administer propofol bolus at 2mg/kg,followed by an infusion of propofol at 100 mcg/kg/min. Upper airway images will be obtained 5 mins after the patient is stable on this infusion.
~After the initial set of images is obtained, the depth of anesthesia will be increased by administering a bolus dose of 1mg/kg propofol and infusion increased to 240mcg/kg/min.
~Image acquisitions will be repeated approximately 5 min after the increase in infusion rate."
16185406|NCT01505920|Procedure|Lidocaine spray|10% lidocaine spray 40 mg applied directly to the cervix, 3 minutes before starting cervical excision
16185407|NCT01505920|Procedure|Lidocaine submucosal injection|2% lidocaine with 1:100,000 adrenaline 2 ml injected submucosally into the four quadrant of the cervix, 3 minutes before starting cervical excision
16185408|NCT01505907|Drug|CXB909|CXB909
16185409|NCT01505894|Drug|BI 409306|High dose film-coated tablet
16185410|NCT01505894|Drug|BI 409306|High dose film-coated tablet
16185411|NCT01505894|Drug|BI 409306 Placebo|Placebo film-coated tablet
16185412|NCT01505894|Drug|BI 409306|Low dose film-coated tablet
16185413|NCT01505894|Drug|BI 409306|Medium dose film-coated tablet
16185414|NCT01505881|Drug|dabigatran etexilate low dose|active treatment (low)
16185415|NCT01505881|Drug|warfarin 5mg|comparator warfarin
16185416|NCT01505881|Drug|dabigatran etexilate intermediate dose|active treatment (medium)
16185417|NCT01505881|Drug|warfarin 1mg|comparator warfarin
16185418|NCT01505881|Drug|dabigatran etexilate high dose|active treatment (high)
16185419|NCT01505881|Drug|warfarin 3mg|comparator warfarin
16185420|NCT01505868|Drug|Cabazitaxel|Given IV
16185421|NCT01505868|Drug|Carboplatin|Given IV
16185422|NCT01505868|Other|Laboratory Biomarker Analysis|Correlative studies
16185423|NCT01505855|Drug|23-valent polysaccharide pneumococcal vaccine|23-valent polysaccharide pneumococcal vaccine (PSV-23 vaccine) 0.5mL single intramuscular injection
16185424|NCT01505842|Procedure|Colonoscopy with Indigo-Carmine chromoendoscopy|Colonoscopy with chromoendoscopy using 0.2-0.5% Indigo-Carmine solution sprayed in the whole colon and rectum plus 32 random biopsies plus biopsies from suspicious areas
16185425|NCT01505842|Procedure|Conventional white-light colonoscopy|White light colonoscopy plus 32 random biopsies plus biopsies from suspicious areas
16185426|NCT01505816|Device|Multifocal Intraocular Lens (RAYNER M-FLEX T TORIC IOL)|Multifocal IOL implantation
16185427|NCT01505803|Dietary Supplement|Zinc supplements|Participants will receive 40 mg of zinc each day for 12 weeks.
16185428|NCT01505803|Dietary Supplement|Omega 3 supplements|Participants will receive 2 g of omega 3 fatty acids each day for 12 weeks.
16185429|NCT01505803|Dietary Supplement|Placebo supplements|Participants will receive placebo supplements each day for 12 weeks.
16185430|NCT01505790|Drug|PRASUGREL|60 mg the first day then 10 mg per day during one month
16185431|NCT01505790|Drug|Clopidogrel|"600 mg clopidogrel will be administered during the first 6 to 12 hours then a measure of platelets reactivity will be done. An additional administration of clopidogrel (600 mg) could be done every 6 hours until to obtain a VASP <50%. No more than 3 * 600mg of clopidogrel will be authorized in this protocol.
~Then for patient which have received more than one dose of clopidogrel 600mg , 150 mg per day of clopidogrel will be administrated, for which who have received only one dose of 600mg of clopidogrel , 75 mg per day will be administrated during one month at least."
16185432|NCT01505777|Drug|Probiotics (Medirac)|10/mosapride 10mg three times a day, P.O. 4week
16185433|NCT01505777|Drug|Probiotics (Medirac)|15/mosapride 10mg three times a day, P.O. 4week
16185434|NCT01505777|Drug|Probiotics (Medirac)|15/mosapride 15mg three times a day, P.O. 4week
16185435|NCT01505777|Drug|Probiotics (Medirac)|30/mosapride 15mg three times a day, P.O. 4week
16185436|NCT01505777|Drug|Probiotics (Medirac) placebo/mosapride placebo|three times a day, P.O. 4week
16185437|NCT01505764|Drug|Anamorelin HCl|100 mg tablets; oral administration every day for 84 days, at least 1 hour before the first meal of the day.
16185438|NCT01505764|Drug|Placebo|Placebo tablets identical in appearance to active tablets; oral administration once a day for 84 days, at least 1 hour before the first meal of the day.
16185439|NCT01505738|Other|bacterial samples|bacterial samples taken
16185440|NCT01505712|Genetic|gene expression analysis|
16185441|NCT01505712|Other|laboratory biomarker analysis|
16185442|NCT01505699|Genetic|RNA analysis|
16185443|NCT01505699|Genetic|cytogenetic analysis|
16185444|NCT01505699|Genetic|microarray analysis|
16185445|NCT01505699|Other|laboratory biomarker analysis|
16185446|NCT01505686|Procedure|MRI scan|MRI scan with a 1,5 T MRI scanner
16185447|NCT01505673|Drug|Liraglutide|Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months
16185448|NCT01505673|Drug|Saline|Placebo injection of 1.8mg saline once daily for 6-months
16185449|NCT01505660|Behavioral|Care management|The intervention will include healthcare delivery team notification of patient reported outcomes (PROs) including medication adherence and adherence barriers such as depression symptoms along with intervention recommendations and targeted care management using a stepped care approach. Patients will receive structured calls from their care manager 2 and 6 weeks after enrollment. An assessment including depression, adherence, and substance use will be completed at the beginning of each call. After the 2nd call, a stepped care approach will be used where patients with a greater need based on adherence and depression will receive more intensive interventions based on the PEARL intervention. The components include: a) problem solving treatment, b) social and physical activation, c) pleasant events scheduling, d) patient support and education regarding medication use, and e) medical and psychiatric consultation. Patients will also receive follow-up calls at ~9 and 12 months after enrollment.
16185450|NCT01505647|Biological|Zoster Vaccine, Live (AMP)|One approximately 0.65-mL injection subcutaneously on Day 1
16185453|NCT01505634|Drug|Relebactam 125 mg|Participants randomized to receive relebactam 125 mg will be administered a 125 mg dose of relebactam IV in a blinded-treatment fashion once every 6 hours with each dose infused over a 30-minute interval.
16185454|NCT01505634|Drug|imipenem/cilastatin 500 mg|A 500 mg dose of imipenem/cilastatin will be administered IV in an open-label fashion once every 6 hours with each dose infused over a 30-minute interval.
16185455|NCT01505634|Drug|Placebo to relebactam|Participants randomized to receive imipenem/cilastatin alone will receive a placebo-matching infusion of IV normal saline (0.9%) once every 6 hours.
16185456|NCT01505634|Drug|Ciprofloxacin|After at least 96 hours of IV treatment, participants may be switched, at the discretion of the investigator, to 500 mg ciprofloxacin, administered orally, twice daily
16185457|NCT01505621|Other|L[ring-13C6]phenylalanine|Oral drink composed of essential amino acids including L[ring-13C6]phenylalanine
16185458|NCT01505608|Drug|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 28-day cycle.
16185459|NCT01505608|Drug|Temozolomide|Oral (PO) Temozolomide at a dose of 100mg/m2 on days 1-5 of each 28 day cycle
16185460|NCT01505608|Drug|Irinotecan|Intravenous (IV) Irinotecan at a dose of 10mg/m2 on days 1-5 and 8-12 of each 28 day cycle.
16185461|NCT01505595|Other|Proprioceptive training|12 weeks
16185462|NCT01505595|Other|Sham proprioceptive training|Three times daily inspiratory muscle training (2x30 breaths) at an intensity of 10% Pi,max
16185463|NCT01505582|Other|Inspiratory muscle training|Three times daily inspiratory muscle training (2x30 breaths) at an intensity of 60% Pi,max
16185464|NCT01505582|Other|Sham inspiratory muscle training|Three times daily inspiratory muscle training (2x30 breaths) at an intensity of 10% Pi,max
16185465|NCT01505569|Drug|Ifosfamide|"Arms A&B: 1.8 g/m^2/day intravenously (IV) over 1 hour; given in a window of 30-100 days before transplant for 5 days before conditioning regimen
~Arm C: 2000 mg/m^2 IV daily on Days 1-3 every 14 days for 2 cycles"
16185466|NCT01505569|Drug|Etoposide|"Arms A&B: 100 mg/m^2/day intravenously (IV) over 1 hour; given in a window of 30-100 days before transplant for 5 days prior to conditioning regimen.
~Arm C: 400 mg/m^2 daily on days -4, -3, and -2 every 21 days
~Arm D: Etoposide 8.3 mg/kg (or 250mg/m² if age >36 mos.) approx. hour 75 on days -5, -4, and -3"
16185467|NCT01505569|Drug|Mesna|"Arms A&B: 1.8 g/m^2/day divided in every 6 hrs dosing; given in a window of 30-100 days before transplant for 5 days prior to conditioning regimen.
~Arm C: 2000 mg/m^2 IV daily on Days 1-3 every 14 days for 2 cycles"
16185468|NCT01505569|Biological|G-CSF|"Arms A&B: Beginning 24 hours after treatment with ifosfamide, etoposide and mesna, administer 10 mcg/kg/day subcutaneously (SQ) or intravenously (IV) until absolute neutrophil count (ANC) is greater than (>) 1,000/mm^2. Starting that day, increase dose to 15 mcg/kg/day SQ or IV given as a single injection for 3 doses. G-CSF, 5 ug/kg/day IV as a bolus injection each evening beginning on day 0 until the ANC is >2500 x 10^9/L for 2 consecutive days. G-CSF will subsequently be restarted at 5 ug/kg/day SC or IV if the ANC falls below 1000/mm^3
~Arm C: 10 μg/kg SQ daily beginning 6 hours after ifosfamide on day 3 until adequate CD34+ cell collection or day 15, whichever occurs first.
~Arm D: Beginning day +1 following hematopoietic cell reinfusion, patients receive filgrastim at a dose of 5mcg/kg SQ once daily (or 5mcg/Kg IV either daily or twice daily, per institutional preference)
~Arm E: 5 micrograms/kg/dose beginning on Day 0 and continue per institutional preference"
16185469|NCT01505569|Drug|Busulfan|Arm A: 1.1 mg/kg IV every 6 hours on days -8 through -6 Arm E: first dose of busulfan is dosed by mg/kg as appropriate for age and weight. Once the results of pharmacokinetic (PK) studies are known, subsequent daily doses are based upon those results,
16185470|NCT01505569|Drug|Melphalan|Arm A: 50 mg/m^2 intravenously (IV) over 30 min on Days -4 and -5 Arm E:140 mg/m2 AT LEAST 24 hrs after last busulfan dose. Day: -1
16185471|NCT01505569|Drug|Thiotepa|Arm A: 250 mg/m^2 intravenously (IV) over 2 hrs on days -2 and -3 Arm B: 10 mg/kg/day or 300 mg/m^2 IV on days -3 and -2 Arm D: Thiotepa 10 mg/kg (or 300mg/m² if age >36 mos.) approx. hour 72 on days -5, -4, and -3
16185472|NCT01505569|Biological|Autologous stem cell infusion|"Arms A, B & C: On Day 0, stem cells will be infused immediately after thawing over 15-60 minutes per institutional guidelines.
~Arm D: On day 0, peripheral blood hematopoietic progenitor cells (PHPCs) or bone marrow cells will be thawed and re-infused about 72 hours following completion of the last dose of chemotherapy.
~Arm E: stem cells will be infused on Day 0 of Consolidation. Where the DMSO volume in the stem cell product would exceed accepted level for infusion within a 24 hour period, stem cell products may be infused over 2 days to meet this standard."
16185473|NCT01505569|Radiation|Radiation|"Arm A: If a patient is considered for post-transplant irradiation, a disease appropriate full tumor restaging should be done prior to starting.
~Whole lung irradiation (1500cGy in 10 fractions) may be given in patients with prior lung metastasis. Areas of known metastatic disease or PET areas may receive spot irradiation using a dose and method determined to be tolerable by radiation oncology staff. Additional radiation will be given if primary disease has not been irradiated to maximum tolerated dose."
16185474|NCT01505569|Drug|Carboplatin|Arm B: depending on age and GFR 17mg/kg/day IV over 4 hours or 510 mg/m^2/day IV over 4 hours Arm C: AUC=8 daily on days -4, -3, and -2 every 21 days Arm D: as calculated from AUC of 7 approx. hour 0 on days -8, -7, and -6
16185475|NCT01505569|Drug|Paclitaxel|Arm C: 200 mg/m2 IV over 3 hours on Day 1 every 14 days for 2 cycles
16185476|NCT01505569|Procedure|Leukapheresis|Arm C: Blood will be taken by a needle placed in one arm and processed through a machine, which spins the blood so that the white blood cells will be separated out in the machine for purposes of this research and the rest of the blood will be returned through a needle in the other arm.
16185477|NCT01505569|Drug|Anti-seizure prophylaxis|"Arm E: Lorazepam OR Levetaracetam
~Lorazepam should be given 0.02-0.05 mg/kg/dose, given 30 minutes prior to each busulfan dose and then continuing every 6 hours, maximum dose: 2 mg.
~Levetiracetam should be given 10 mg/kg/dose PO, administered BID, staring 12 hours prior to busulfan, maximum single dose: 1000mg."
16185478|NCT01505569|Drug|Ursodiol|Arm E: 150 mg/m2/dose PO, administered BID, beginning on Day -7 and continuing a minimum of 28 days post-transplant, or until the end of Consolidation.
16185479|NCT01505530|Drug|LY2495655|Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops.
16185480|NCT01505530|Drug|Placebo|Intravenous (IV) treatment every 14 days while on study. Number of Cycles: until treatment options are exhausted or unacceptable toxicity develops.
16185481|NCT01505530|Drug|Standard of Care Chemotherapy|Standard of care, gemcitabine-based regimen (single-agent gemcitabine or gemcitabine plus erlotinib) or FOLFIRINOX (combination chemotherapy regimen including 5-fluorouracil, leucovorin, oxaliplatin, and irinotecan). The choice of gemcitabine-based regimen or FOLFIRINOX will be determined by the investigator (based on the standard of care used at the treating institution or as directed by local regulatory authorities).
16185482|NCT01505504|Drug|mirtazapine|30 mg at bedtime
16185483|NCT01505491|Drug|adalimumab|40mg adalimumab single s.c. injection
16185484|NCT01505491|Drug|BI695501|BI 695501 single s.c injection
16185485|NCT01505491|Drug|adalimumab|40mg adalimumab single s.c. injection
16185486|NCT01505465|Drug|Melatonin|5mg of melatonin will be taken by the subject for 3 nights prior and continuing 3 nights after surgery as tolerated.
16185487|NCT01505465|Drug|Placebo|5mg of placebo will be taken by the subject 3 nights prior to surgery and continuing 3 nights after surgery
16185488|NCT01505439|Drug|solifenacin|oral
16185489|NCT01505426|Drug|ASP1941|oral
16185490|NCT01505426|Drug|metformin|oral, concomitant use
16185491|NCT01505426|Drug|Placebo|oral
16185492|NCT01505413|Drug|Erlotinib|Erlotinib 100 mg po qd daily
16185493|NCT01505413|Drug|Gemcitabine|Gemcitabine 1000 mg/m² with 150mL of normal saline intravenously infusion over 100min on Day 1
16185494|NCT01505413|Drug|Oxaliplatin|Oxaliplatin 100 mg/m2 with 500mL of 5DW intravenously a 2-hour infusion on D2
16185495|NCT01505387|Dietary Supplement|Litramine|Fibre complex of plant origin in tablet form 2 tablets 3 times daily (oral consumption, after meal)
16185496|NCT01505387|Dietary Supplement|Placebo|Identical to Litramine tablets 2 tablets 3 times daily (oral consumption, after meal)
16185497|NCT01505374|Procedure|Study Technique|One leg will receive the saphenous nerve block, at the level of the adductor canal (study technique). The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
16185498|NCT01505374|Procedure|Control Technique|The other leg will receive the femoral nerve block (control technique). The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivacaine. All study patients, regardless of study arm will receive combined spinal epidural, with 3 ml of 0.5% bupivacaine as the spinal agent. Epidural local anesthetic, if needed, will consist of 2% lidocaine.
16185499|NCT01505361|Biological|Lactobacillus salivarius PS2|9 log10 (colony-forming units), freeze-dried powder, daily for 30 week of pregnancy until birth
16185500|NCT01505361|Biological|Excipient (milk powder)|100 mg/once a day from 30 week of pregnancy until birth
16185501|NCT01505348|Other|Overnight fast|Overnight fast from 21:00 h
16185502|NCT01505335|Device|US depth measurements|Measurement of the distance between the apex of the drilled implant site and the IAC
16185503|NCT01505309|Device|Stent Graft (Medtronic, Microport, Ankura)|Medtronic Stent Graft（Medtronic Medtronic, Inc., US） Microport Stent Graft（Microport Co.,LTD.，Shanghai, China） Ankura Stent Graft（Lifetech Scientific Co.,LTD.，Shenzhen, China）
16185504|NCT01505296|Drug|Antiarrhythmic drug|propafenone, flecainide, sotalol, dofetilide
16185505|NCT01505296|Procedure|Catheter ablation|Complete PVI
16185506|NCT01505283|Drug|NaCl 0.9%|epidural administration of 6 ml of NaCl 0.9%
16185507|NCT01505283|Drug|Sufentanil|epidural administration of sufentanil 10 µg
16185508|NCT01505283|Drug|lidocaine|epidural administration of lidocaine 50 mg
16185509|NCT01505270|Other|Retrospective case study|Retrospective case study
16185510|NCT01505257|Behavioral|END-DSD|Multi-component intervention including 1) Nursing education regarding detection and management of delirium superimposed on dementia; 2) Computerized decision support and EHR; 3) A unit champion nurse for promotion of delirium assessment and management; 4) Feedback to nursing staff
16185511|NCT01505244|Behavioral|Before-School Physical Activity|3 days/week of before-school moderate to vigorous physical activity
16185512|NCT01505231|Drug|Vasopressin|Blinded Vasopressin will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement.
16185513|NCT01505231|Drug|Norepinephrine|Blinded Norepinephrine will be started if there is persistent hypotension, characterized by mean arterial pressure <65 mmHg after fluid replacement
16185514|NCT01505218|Drug|Propofol sedation by nurse anaesthestist|"Propofol (10 mg/ml) is a short-acting, intravenously administered hypnotic agent used for light-moderate-deep sedation.
~Patient-controlled sedation: self-administration of propofol boluses of 5 mg with zero lock-out time. Administration time for the pump was 12 sec, equivalent to maximum delivery of 25 mg of propofol per minute.
~Propofol sedation by nurse anaesthetists:"
16185515|NCT01505218|Drug|Patient-controlled propofol sedation|"Propofol (10 mg/ml) is a short-acting, intravenously administered hypnotic agent used for light-moderate-deep sedation.
~Self-administration of propofol via patient-controlled sedation pump (CME T-34L PCA). No programmed lock-out period, no dose limit or background infusion. 5 mg propofol/effectuated demand from the patients. Capacity of the pump was 6 possible doses per minute.
~Before start of ERCP the patients were allowed to sedate themselves to a sense of heavy tiredness."
16185516|NCT01505192|Device|continuous Hb monitor|Pre and post partum non invasive continuous Hb monitor
16185517|NCT01505179|Drug|Ranolazine|Patients with be given 500 mg by mouth twice a day for three days, and then the dose will be increased to 1000 mg by mouth twice daily thereafter. (patients who concurrently take moderate CYP3A inhibitors including diltiazem, verapamil, aprepitant, erythromycin, and fluconazole will continue to 500 mg by mouth twice a day for the entire dosing period)
16185518|NCT01505179|Drug|Placebo|Patients will be given 1 tab twice a day for 3 days, then increasing to 2 tabs twice a day thereafter (patients who concurrently take moderate CYP3A inhibitors, will be given 1 tab twice daily for the entire dosing period)
16185519|NCT01505166|Biological|Vigil™ Vaccine|Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks).
16185520|NCT01505166|Drug|Placebo|Patients will receive 1 x 10^7 cells (Group A) or placebo (Group B) via intradermal injection for a minimum of 5 doses and a maximum of 12 doses starting post-surgery Week 4-8 (C1W1D1) and continuing C1W3D1, C2W3D1, then every 28 days. Starting C1W4D1, all patients will receive modified FOLFOX6 (oxaliplatin 85 mg/m2 D1, l-leucovorin 200 mg/m2 D1, fluorouracil 400 mg/m2 IV bolus (or short infusion) D1, fluorouracil 2400 mg/m2 46 hours continuous infusion every 14 days x 6 cycles (1 cycle = 4 weeks).
16185521|NCT01505153|Biological|pbi-shRNA STMN1 LP|This is a Phase I safety trial of bifunctional shRNA-STMN1 (pbi-shRNA™STMN1) BIV (bilamellar invaginated vesicle) lipoplex (LP), pbi-shRNA™ STMN1 LP administered by a single intratumoral (IT) injection. Patients will accrue in 4-patient escalation cohorts using a modified Fibronacci escalation schema at a starting intratumoral dose of 0.010 mg/kg of DNA through a dose of 0.053 mg/kg DNA intratumoral / single dose.
16185522|NCT01505140|Other|Whole walnuts|75 gm whole walnuts per day will be consumed with usual Western style diet
16185523|NCT01505127|Drug|TAK-438|
16185524|NCT01505127|Drug|Lansoprazole|
16185525|NCT01505127|Drug|Amoxicillin|
16185526|NCT01505127|Drug|Clarithromycin|
16185527|NCT01505114|Drug|Maraviroc|300-mg tablet, once daily, from Week 0 through Week 48
16185528|NCT01505114|Drug|Emtricitabine|200-mg capsule, once daily, from Week 0 through Week 48
16185529|NCT01505114|Drug|Tenofovir disoproxil fumarate|300-mg tablet, once daily, from Week 0 through Week 48
16185530|NCT01505114|Other|Maraviroc placebo|Once daily from Week 0 through Week 48
16185531|NCT01505114|Other|Emtricitabine placebo|Once daily from Week 0 through Week 48
16185532|NCT01505114|Other|Tenofovir disoproxil fumarate placebo|Once daily from Week 0 through Week 48
16185533|NCT01505101|Behavioral|Mindfulness-Oriented Recovery Enhancement|MORE is a multimodal, dual-process group intervention involving mindfulness training, cognitive restructuring, and positive emotion induction. MORE consists of eight, weekly, two-hour group sessions led by a trained therapist.
16185534|NCT01505101|Behavioral|Conventional Support Group (SG)|The control arm will participate in a time-matched, conventional SG led by a Master's level therapist, discussing topics pertinent to chronic pain and opioid misuse. The SG format is adapted from the support group detailed in the evidence-based, Matrix Intensive Outpatient Treatment manual. The SG consists of eight, weekly, two-hour sessions.
16185535|NCT01505088|Drug|40 mg/mL Dexamethasone phosphate ophthalmic solution|Transscleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis)
16185536|NCT01505088|Drug|Prednisolone Acetate (1%) Eyedrops|Prednisolone acetate (1%) eyedrops
16185537|NCT01505088|Drug|100 mM sodium citrate buffer solution|Transscleral iontophoresis delivery of 100 mM Sodium citrate buffer solution
16185538|NCT01505088|Drug|Placebo Eyedrops|Placebo Eyedrops
16185539|NCT01505075|Radiation|Hypofractionated radiation|40 Gy in 5 fractions to prostate, 30 Gy in 5 fractions to seminal vesicles; total treatment duration 29 days
16185540|NCT01505062|Drug|SAR421869|"Formulation: Sterile suspension for intraocular injection, 100 microliters (μL) aliquots in 0.3 milliliter (mL) type I borosilicate glass 'V' vials with a butyl stopper and aluminum crimp seal.
~Route of administration: subretinal injection"
16185541|NCT01505049|Drug|quadrivalent HPV vaccine|For the group who have received two prior doses of vaccine, the third and final dose of vaccine will be given. For the unvaccinated cohort, women will receive all three doses of the vaccine. The second dose of the vaccine will be given two months after the first dose. The third and final dose of the vaccine will be given six months after the first dose.
16185542|NCT01505036|Other|SMARTCARE service|U-Healthcare service
16185543|NCT01505023|Dietary Supplement|Partial meal replacement|The PMR was designed to contain sufficient amounts of all vitamins and minerals. Women were instructed to consume 2 servings per day at breakfast and dinner, each consisting of 33 g of powder dissolved in 250 ml of skim milk.
16185544|NCT01505023|Dietary Supplement|Partial meal replacement with inulin|The PMR was designed to contain sufficient amounts of all vitamins and minerals plus inulin. Women were instructed to consume 2 servings per day at breakfast and dinner, each consisting of 33 g of powder dissolved in 250 ml of skim milk.
16185545|NCT01505023|Dietary Supplement|Inulin|Women were asked to consume one 5g serving of inulin mixed with any drink at breakfast and same amount at dinner (10 g of inulin/d).
16185546|NCT01505010|Procedure|Renal denervation|Renal denervation in the intervention group
16185547|NCT01504997|Device|Robot assisted distal gastrectomy (DaVinci)|patients who received robot assisted distal gastrectomy
16185548|NCT01504984|Drug|SYO-1126|Imatinib 400mg/tablet, PO, 1 tablet once daily for I&II D1(crossover)
16185549|NCT01504984|Drug|Glivec film coated tab 4T(400mg)|Imatinib 100mg/tablet, PO, 4 tablets once daily for period I&II D1(crossover)
16185550|NCT01504971|Other|symptom questionaire|GerdQ questionaire
16185551|NCT01504971|Procedure|pH monitoring|24-hour pH monitoring
16185552|NCT01504971|Procedure|Tri-modal imaging endoscopy|To investigate WLI,NBI and AFI
16185553|NCT01504971|Drug|rabeprazole|10mg, bid, p.o.
16185554|NCT01504958|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|"Each subject will receive up to 1800 pulses of up to 20Hz per day to all simulated brain regions together. Treated brain areas will be alternated each day (only 3 a day).
~Sham participants will receive the same study procedures as patients receiving active rTMS."
16185555|NCT01504958|Behavioral|NICE Cognitive Training|"12 levels of difficulty in tasks designed to relate to the region of the brain being stimulated (left and right parietal cortex, left and right DLPFC, left superior temporal gyrus, left inferior frontal gyrus).
~A particular cognitive exercise will start 200msec after the termination of each TMS train.
~Sham participants receive sham cognitive training that follows the same procedures as the active group."
16185556|NCT01504945|Other|RBC transfusion|1 bag of packed red blood cells
16185557|NCT01504945|Other|Normal saline infusion|500 mL of normal saline infusion
16185558|NCT01504932|Dietary Supplement|BRB Lozenge|ARM I: Patients will be instructed to begin BRB administration and continue daily for up to 6 months.
16185559|NCT01504932|Other|Survey Administration|Patients will complete a baseline survey documenting any family history of cancer. Patients will then provide a history of tobacco, alcohol and mouthwash use, complete the Head and Neck Cancer Inventory Survey (HNCI), the Insomnia Severity Index (ISI) Survey, and the Brief Fatigue Inventory (BFI) Survey. Patients will receive a trial-specific logbook to record their usages.
16185560|NCT01504932|Other|Laboratory Biomarker Analysis|Patients will provide blood, urine, saliva, and cheek scrape samples. These biological samples will be evaluated for the presence of BRB components (as a measure of compliance) and assessed for BRB-responsive gene expression, respectively.
16185561|NCT01504932|Other|pharmacological study|Correlative studies
16185562|NCT01504919|Behavioral|Health Education|Brief counseling at baseline, at 6 months and again at 12 months, and self-help materials addressing smoking cessation, diet, physical activity, referrals to available resources, and a home-based exercise kit (e.g., pedometer, exercise ball, strength training cables).
16185563|NCT01504919|Behavioral|Questionnaires|Computer-based questionnaires completed at baseline, then every 6 months taking 60-90 minutes to complete.
16185564|NCT01504919|Behavioral|Telephone Counseling Sessions|9 proactive, telephone counseling sessions over 18 months. Each of these phone calls should last about 20-30 minutes.
16185565|NCT01504919|Drug|Nicotine Patches|6-week supply of nicotine patches given to participants ready to quit smoking.
16185566|NCT01504906|Drug|cyclosporine|Oral tablets, 600 mg , single dose
16185567|NCT01504906|Drug|ticagrelor|Oral tablets, 180 mg, single dose
16185568|NCT01504893|Procedure|protective ventilation|Low tidal volume, PEEP and recruitment maneuver
16185569|NCT01504867|Drug|Aspirin|325mg loading dose once on study day 1, followed by 81mg dose once daily on study days 2-7. Administered by mouth or down nasal gastric tube.
16185570|NCT01504867|Drug|Lactose powder|Matching lactose powder filled capsules will be administered on days 1-7.
16185571|NCT01504854|Drug|Resveratrol|The dosage will begin at 500 mg taken once daily and increase at 13 week intervals to 1 gram taken by mouth twice daily, supplied as 500 mg capsules (two capsules twice daily).
16185572|NCT01504854|Drug|Placebo|The matching placebo will begin at a capsule taken once daily and increase at 13 week intervals to two capsules twice daily.
16185573|NCT01504841|Drug|Etravirine (ETR)|ETR was administered as 25-mg scored tablets and/or 100-mg tablets swallowed whole or dispersed in an appropriate liquid vehicle following a meal. Children took the specified dose orally twice daily within 30 minutes following a meal. Dose was decided according to dosing tables in protocol.
16185574|NCT01504828|Drug|Ramipril|Ramipril in one dose to reduce vascular stiffness to determine effects of this on left ventricular function and energetics
16185575|NCT01504815|Drug|cisplatinum|i.v. 100 mg/m2 on days 1, 22 and 43 of radiotherapy
16185576|NCT01504815|Radiation|Conventional radiotherapy|conventional radiotherapy, 70Gy in 7 weeks
16185577|NCT01504815|Radiation|Adaptive radiotherapy|adaptive high dose radiotherapy up to 84 Gy max on 50% uptake GTV in 7 weeks
16185578|NCT01504789|Behavioral|Baseline Fitness Test|Complete fitness tests to measure strength, flexibility, balance, and aerobic capacity. All of the baseline fitness tests will be repeated at the end of the program (at about the 16th week) during a follow-up visit.
16185579|NCT01504789|Behavioral|Questionnaires|At the baseline visit, complete questionnaires about demographic information taking about 35 minutes to complete. At 6 months after the follow-up visit, a packet of follow-up questionnaires about physical activity and quality of life will be mailed or given over the phone. It should take about 10 minutes to complete these questionnaires. Patients also be asked to fill out a questionnaire every week that asks about level of physical activity. The questionnaire should take about 5 minutes to complete.
16185580|NCT01504789|Behavioral|Individualized Exercise Program|The exercise programs will be individualized based on results from baseline fitness assessments and individual medical history using ACSM guidelines. For resistance and flexibility exercises each patient will receive an exercise prescription and instructional session prior to beginning the program. Invitation extended to attend monthly Group Exercise sessions with a family member. Resistance tubes, pedometer, exercise book, and video issued for use at home.
16185581|NCT01504789|Behavioral|Written Materials|Either culturally adapted AI materials or non-culturally intervention materials will be mailed to patients every 2 weeks. The 7 themed sessions are: Getting Started;Goal Setting;Effective Energy Balance;Getting Confident;Uncovering Barriers;Lapsing, Relapsing, Collapsing;and Continuing to be Active.
16185582|NCT01504776|Drug|Panobinostat|Dose escalation study of oral panobinostat administered Monday-Wednesday-Friday (MWF) weekly x 4 weeks, utilizing 3+3 dosing scheme (15, 20, 25 mg) in combination with a fixed dose of bortezomib 1.3 mg/m2 administered as a short intravenous (IV)infusion of 3-5 seconds every week x 4 weeks, representing one cycle. Each week, bortezomib will be administered IV prior to the oral dose of panobinostat
16185583|NCT01504776|Drug|Bortezomib|
16185584|NCT01504763|Procedure|Chair massage|Chair massage for 15 minutes once a week for 10 weeks.
16185585|NCT01504750|Procedure|dynamic daylight and atmosphere lighting|In the ceiling, luminaires are installed that offer the basic lighting in the patient room that will automatically and gradually change in light level (100-300 lux) and color temperature (3000-4000 K). This so called daily rhythm light meets the EN12464-1 standard for patient rooms in hospitals. The system offers a light boost by bringing the illuminance to a level of maximal 2000 lux and 7000 K, during a period of two hours in the morning. Besides, a low intensity color cove as well as some white LED spots are added to create a pleasant ambience in the patient room. The illuminance is between 50 and 60 lux and, depending on the color choice, the color temperature is 2300 K (relax) or 3800 K (active). The lighting solution used is HealWell of Philips Lighting.
16185586|NCT01504737|Other|Aerobic Exercise Training|12 weeks of endurance training, 40 minutes, 3 times per week on ergometer bicycle.
16185587|NCT01504737|Other|Physical Activity Recommendations|Written and verbal information on minimal level of physical activity recommended.
16185588|NCT01504724|Drug|bevacizumab|intravitreal bevacizumab injection (1.25 mg/0.05 mL) was done 4.0 mm posterior to the corneal limbus using a 30-gauge needle after topical anesthesia
16185589|NCT01504711|Drug|fosaprepitant dimeglumine|Given IV
16185590|NCT01504698|Procedure|Advice and exercise-based treatment plus joint manipulation|The treatment can consist of advice, activation and exercise and/or manual soft-tissue treatment plus joint manipulation.The areas and frequency of manipulative treatment will be determined by the chiropractor and will consist of high-velocity, low-amplitude manipulation and/or mobilization to the spine and/or the extremities.
16185591|NCT01504698|Procedure|Advice and exercise-based treatment|The treatment can consist of advice, activation and exercise and/or manual soft-tissue treatment. However, assisted stretching is not allowed as this will approach mobilization.
16185592|NCT01504685|Procedure|Banded Laparoscopic Roux-en-Y gastric bypass|"A 6.5-cm polypropylene Marlex mesh was placed immediately cephalad to the gastrojejunostomy. The gastrojejunostomy was hand-sewn in 2 layers using 3-0 Polyglactin for the internal and 3-0 silk for the external layer.
~The length of alimentary and biliopancreatic limbs was approximately 150 cm and 50 cm, respectively."
16185593|NCT01504685|Procedure|Unbanded Laparoscopic Roux- en-Y gastric bypass|"A hand-sewn gastrojejunostomy in 2 layers using 3-0 Polyglactin for the internal and 3-0 silk for the external layer.
~To ensure a diameter of 1-1.5 cm,a 32F bougie was used to calibrate the gastro jejunum anastomosis. The length of alimentary and biliopancreatic limbs was approximately 150 cm and 50 cm, respectively."
16185594|NCT01504672|Other|Medication review|"In the intervention, the pharmacist will evaluate:
~Is there an indication for the drug?
~Has the drug desired effect?
~Is the dose correct and dosing scheme correct?
~Side effects, contraindications, inappropriate drugs
~Interactions
~Treatment time
~Cost effectiveness
~Adherence to recommendation list
~Problems with handling the drugs (for example crushing of the tablets)
~Untreated indication
~Double medications
~Administration of drugs"
16185595|NCT01504659|Drug|Ketamine hydrochloride injection|Separate dosing regimens will be applied depending on the weight of the child. Group A with minimum-maximum weight of 20 kg-40 kg will receive a fixed initial dose of 10 mg ketamine(0.25-0.5mg/kg)and will not exceed a maximum dose of 40 mg ketamine. Group B with minimum - maximum weight of 40.01kg-100kg will get a fixed initial dose of 20 mg ketamine(0.20-0.5mg/kg) and will not exceed a maximum dose of 120mg. ketamine. There will be 4 administrations of the drug at three day intervals. Titration upward will depend upon degree of side effects, improvement from baseline on primary measures, subjective opinion. Doses will be held constant as long as a therapuetic response, as measure of 80% improvement on YBOCS and YMRS, is reached.
16185596|NCT01504659|Drug|Flat tonic water (e.g., Canada Dry Tonic Water)|Separate dosing regimens will be applied depending on the weight of the child. Group A with minimum-maximum weight of 20 kg-40 kg will receive a fixed initial dose of 0.1cc placebo and not exceed a maximum dose of 0.4cc placebo. Group B with minimum - maximum weight of 40.01kg-100kg will get a fixed initial dose of 0.2cc placebo and will not exceed a maximum dose of 1.2cc. placebo. There will be 4 administrations of the placebo at three day intervals. Titration upward will depend upon degree of side effects, improvement from baseline on primary measures, and subjective opinion. Doses will be held constant as long as a therapuetic response, as a measure of 80% improvement on YBOCS and YMRS, is reached.
16185597|NCT01504646|Dietary Supplement|Lyprinol|8 capsules (1 capsule=50mg n-PUFA, 100mg olive oil) per day for 3 weeks
16185598|NCT01504646|Dietary Supplement|Placebo (Olive Oil)|8 capsules (1 capsule = 100mg olive oil) per day for 3 weeks
16185599|NCT01504633|Dietary Supplement|DHA/EPA and iron supplementation|24-week supplementation consisting of daily dosage of DHA/EPA or placebo capsule and iron/placebo syrup Capsule: DHA/EPA (100mg DHA + 20mg per day) or placebo Syrup: Fe syrup (16mg elemental iron per day) or placebo
16185600|NCT01504620|Other|Sugar infusion|Infusion of glucose to achieve high blood glucose levels
16185601|NCT01504620|Drug|insulin infusion|i.v. infusion of insulin
16185602|NCT01504607|Procedure|Congenital Cataract Surgery|Congenital cataract surgery with IOL implantation
16185603|NCT01504594|Procedure|Intracoronary autologous stem cell infusion|Under sedation and under sterile conditions in a fluoroscopy operation room, cardiac catheterization will be performed through the femoral artery to infuse the stem cells directly into the heart´s coronary arteries.
16185604|NCT01504581|Biological|HM10660A|Single dose of HM10660A 1.5, 2.25, 3.0, or 4.0 ug/kg
16185605|NCT01504581|Biological|HM10660A placebo|Single dose of HM10660A Placebo
16185606|NCT01504581|Biological|Pegasys|Single dose of Pegasys 180ug
16185607|NCT01504568|Other|Treatment|Adults: ≥40 kg:250mg every eight hours Children: <40kg: 20mg/kg/day divided in three doses (up to 250mg) every eight hours Suspension form 250mg/ml
16185608|NCT01504542|Biological|HS110 vaccine|0.5ml to be administered twice weekly for 18 weeks (36 doses)
16185609|NCT01504542|Biological|Placebo|0.5ml buffered saline placebo to be administered twice weekly for 18 weeks (36 doses)
16185610|NCT01504542|Biological|HS110 vaccine|0.5 mls to be dosed twice weekly for 18 weeks (36 doses)
16185611|NCT01504516|Drug|Donepezil Hydrochloride|Donepezil Hydrochloride Tablets 10 mg
16185612|NCT01504516|Drug|Aricept|Aricept 10 mg Tablets
16185613|NCT01504503|Drug|Donepezil Hydrochloride|Donepezil Hydrochloride Tablets 10 mg
16185614|NCT01504503|Drug|Aricept|Aricept 10 mg Tablets
16185615|NCT01504490|Drug|CS-7017 and Bexarotene|"CS-7017 will be administered orally, twice daily for 28 days of each 28-day cycle in escalating doses depending on cohort patient is assigned to.
~Bexarotene will be administered orally once daily for 28 days of each 28-day cycle. The dose a patient receives will depend on which cohort the patient is assigned to."
16185616|NCT01504477|Drug|Panitumumab and bortezomib|"Panitumumab 6 mg/kg IV over 60 minutes on Day -14 (first cycle only), then Day 1 and 15 of each 28-day cycle.
~Bortezomib will be administered in escalating doses until the maximum tolerated dose is determined and then at the maximum tolerated dose as an IV bolus injection over 3-5 seconds on Day 1, 8, and 15 of each 28-day cycle."
16185617|NCT01504464|Biological|mesenchymal stem cell|intra articular injection of mesenchymal stem cell
16185618|NCT01504464|Biological|Placebo|Patients with knee joint osteoarthritis who underwent intra articular placebo injection
16185619|NCT01504451|Device|ILR insertion|Insertion of implantable loop recorder
16185620|NCT01504451|Procedure|AF ablation|AF ablation
16185621|NCT01504438|Device|Salto-Talaris Total Ankle Replacement|Salto-Talaris Total ankle replacement surgery
16185622|NCT01504438|Device|STAR Total Ankle Replacement|STAR Total Ankle Replacement
16185623|NCT01504412|Drug|DS-5565|Oral tablets administered twice daily
16185624|NCT01504412|Drug|DS-5565|Oral tablets administered twice daily
16185625|NCT01504412|Drug|DS-5565|Oral tablets administered twice daily
16185626|NCT01504412|Drug|Placebo|DS-5565 placebo oral tablets and pregabalin placebo oral capsules administered 2 times per day
16185627|NCT01504412|Drug|Pregabalin capsules|Pregabalin oral capsules 150 mg administered twice a day
16185628|NCT01504386|Procedure|TAP block|Bilateral UL-guided TAP block with 20 ml of ropivacaine 0.5 %
16185629|NCT01504386|Procedure|Placebo TAP block|Bilateral placement of 20 ml of saline 0.9 % in the transversus abdominis plane
16185631|NCT01504360|Genetic|tumor genetic predisposition to develop sarcoma assessment|data concerning initial radiation and localisation of the sarcoma secondary developed will be collected. 2 blood samples (2 x 5 ml)will be collected. One sample of 5 mm will be dedicated to study radiation induced apoptosis assessed by flow cytometry. The second sample will be used to study the polymorphism of the genes involved in reparation of DNA by using chip screening of single nucleotide polymorphisms (SNP). DNA will be extracted and controlled by flow cytometrical separation.
16185632|NCT01504360|Genetic|tumor genetic predisposition to develop sarcoma assessment|data concerning initial radiation and data demonstrating the lack of secondary sarcoma will be collected . 2 blood samples (2 x 5 ml)will be collected. One sample of 5 mm will be dedicated to study radiation induced apoptosis assessed by flow cytometry. The second sample will be used to study the polymorphism of the genes involved in reparation of DNA by using chip screening of single nucleotide polymorphisms (SNP). DNA will be extracted and controlled by flow cytometrical separation.
16185633|NCT01504347|Biological|Multivalent recombinant OspA Lyme Borreliosis Vaccine|Primary vaccination (6 study arms of 50 subjects each): 3 intramuscular injections containing either dose A, B or C in an adjuvanted or non-adjuvanted formulation (6 different formulations) given in monthly intervals (recruited in 3 sequential cohorts)
16185634|NCT01504347|Biological|Multivalent recombinant OspA Lyme Borreliosis Vaccine|Booster vaccination 9-12 months after first vaccination in Section 1 subjects
16185635|NCT01504347|Biological|Multivalent recombinant OspA Lyme Borreliosis Vaccine|3 intramuscular injections at monthly intervals (using 2 formulations selected from Section 1) in seronegative and seropositive subjects (N=350) and a booster vaccination at 6 months or at 9-12 months (Cohorts 4: seronegatives; Cohort 5: seropositives)
16185636|NCT01504334|Drug|Pirfenidone|Pirfenidone（200mg）tablets will be taken 3 times a day during the whole study process. For the first week, 1 tablet will be taken each time. For the second week, 2 tablets will be taken each time. From the third week to the 48th week, 3 tablets will be taken each time. Base drug Acetyl Cysteine Tablets（600mg）will be taken once a day, 1 tablet each time from the first to the 48th week.
16185637|NCT01504334|Drug|Placebo|Placebo（without active ingredient） tablets will be taken 3 times a day during the whole study process. For the first week, 1 tablet will be taken each time. For the second week, 2 tablets will be taken each time. From the third week to the 48th week, 3 tablets will be taken each time. Base drug Acetyl Cysteine Tablets（600mg）will be taken once a day, 1 tablet each time from the first to the 48th week for both groups.
16185638|NCT01504321|Drug|Moxonidine|0.2 mg/day moxonidine for 2 weeks 0.4 mg/day moxonidine for 3 months
16185639|NCT01504321|Drug|Placebo|Encapsulated lactose powder
16185640|NCT01504308|Device|MR-HIFU treatment|A treatment session with the Philips Sonalleve MR-HIFU device for thermal ablation of uterine fibroids with high-intensity focused ultrasound.
16185641|NCT01504308|Device|Sham treatment|A pretend treatment session with the Philips Sonalleve MR-HIFU system in which no therapeutic ultrasound doses are delivered.
16185642|NCT01504295|Drug|Metadoxine|Improve Liver Function and Reduce ALcohol Use
16185643|NCT01504282|Drug|mitomycin-C|
16185644|NCT01504282|Drug|Placebo|balanced salt solution (BSS)
16185645|NCT01504256|Drug|catumaxomab, Fluorouracil, leucovorin, oxaliplatin, docetaxel|"Catumaxomab: 4 intraperitoneal infusions of catumaxomab at an escalating dose of 10µg (d0), 20µg (d3), 50µg (d7), and 150µg (d10)
~and 7 days after the last catumaxomab infusion
~FLOT; 6 cycles q2w: Fluorouracil 2600 mg/m² as 24h infusion (d1) , leucovorin 200mg/m² (d1), oxaliplatin 85 mg{m² (d1), docetaxel 50 mg/m² (d1)"
16185646|NCT01504256|Drug|Fluorouracil, leucovorin, oxaliplatin, docetaxel|"FLOT; 6 cycles q2w:
~Fluorouracil 2600 mg/m² as 24h infusion (d1) leucovorin 200mg/m² (d1) oxaliplatin 85 mg{m² (d1) docetaxel 50 mg/m² (d1)"
16185647|NCT01504204|Drug|Adapalene + benzoyl peroxide samples|A sample size tube of the study medication, combination adapalene 0.1% plus benzoyl peroxide 2.5% gel, will be provided with instruction on proper application, including demonstration, at the first visit.
16185648|NCT01504204|Drug|Adapalene + benzoyl peroxide from standard tube|Subjects are instructed to apply the combination adapalene 0.1% plus benzoyl peroxide 2.5% gel once daily to all affected areas.
16185649|NCT01504191|Behavioral|Internet-based CBT|"The participants read texts and do weekly homework assignments instructed from an Internet page. Additional resources like discussion forum, pictures, animations, videos and sounds will be a part of the treatment program.
~A psychologist will communicate with the participants through internal text-messages. The therapist will devote about 10 minutes to each participant each week via the Internet. The content of the intervention will be standard components from CBT, for example relaxation training, behavioral activation, exposure for fear related stimuli, cognitive restructuring, behavioral sleep treatment etc."
16185650|NCT01504178|Drug|duloxetine|administration during 28 days
16185651|NCT01504178|Drug|placebo of duloxetine|administration during 28 days
16185652|NCT01504178|Drug|injection of apomorphine|injection performed at D28
16185653|NCT01504178|Drug|injection of placebo of apomorphine|performed at D28
16185654|NCT01504178|Drug|L-Dopa|performed at D28
16185655|NCT01504178|Drug|injection of placebo of L-Dopa|performed at D28
16185656|NCT01504165|Drug|cilengitide 2000mg|A single dose of cilengitide 2000mg (250mL) will be administered as 1-hour i.v. infusion on Day 1
16185657|NCT01504165|Drug|cilengitide 2000mg|A single dose of cilengitide 2000mg (250mL) will be administered as 1-hour i.v. infusion on Day 1
16185658|NCT01504165|Drug|cilengitide 2000mg|A single dose of cilengitide 2000mg (250mL) will be administered as 1-hour i.v. infusion on Day 1
16185659|NCT01504165|Drug|cilengitide 1000mg|A single dose of cilengitide 1000mg (125mL) will be administered as 1-hour i.v. infusion on Day 1
16185660|NCT01504165|Drug|cilengitide > 1000mg and up to 2000mg|A single dose of cilengitide > 1000mg and up to 2000mg will be administered as 1-hour i.v. infusion on Day 1 if applicable, based on Safety Monitoring Committee decision
16185661|NCT01504152|Behavioral|questionnaire|The intervention is a self-administered questionnaire that is voluntarily completed by the subject. This questionnaire has been previously validated and demonstrated to be reproducible in English speaking travelers. The final version of the survey questionnaire consists of 49 questions.Patients who never traveled after HSCT will answer only eighteen questions related to their medical and HSCT history in addition to their demographics.
16186411|NCT01498770|Drug|Lurasidone|Lurasidone prescribed as recorded in the CPRD in the UK
16185662|NCT01504139|Drug|hCG(r-hCG, Ovitrelle, Merck-Serono, Hellerup, Denmark) in the late follicular phase + luteal phase|when the follicles are over 12 mm FSH(r-hFSH; Gonal-F, Merck-Serono, Hellerup, Denmark) is replaced by hCG (r-hCG, Ovitrelle,Merck-Serono, Hellerup,Denmark).
16185663|NCT01504139|Drug|hCG(r-hCG, Ovitrelle,Merck-Serono, Hellerup, Denmark) in the follicular phase + luteal phase|hCG(r-hCG,Ovitrelle,Merck-Serono, Hellerup, Denmark) is given together with FSH(r-hFSH; Gonal-F, Merck-Serono, Hellerup, Denmark) from the beginning of the FSH(r-hFSH; Gonal-F, Merck-Serono, Hellerup, Denmark)stimulation.
16185664|NCT01504139|Drug|LH(r-LH,Luveris, Merck-Serono, Hellerup, Denmark) in the luteal phase|LH(r-LH, Luveris, Merck-Serono, Hellerup, Denmark) replaces progesterone and estradiol in the luteal phase.
16185665|NCT01504139|Drug|vaginal progesterone(Crinone; Merck-Serono, Hellerup, Denmark) and estradiol(Estrofem; Novo Nordisk, Copenhagen, Denmark) in the luteal phase|The usual dose of vaginal progesterone(Crinone; Merck-Serono, Hellerup, Denmark) and estradiol (Estrofem; Novo Nordisk, Copenhagen, Denmark) is given in the luteal phase-
16185666|NCT01504126|Drug|Chemotherapy|Undergo standard chemotherapy
16185667|NCT01504126|Drug|Propranolol Hydrochloride|Given PO
16185668|NCT01504126|Other|Quality-of-Life Assessment|Ancillary studies
16185669|NCT01504126|Procedure|Therapeutic Conventional Surgery|Undergo surgical resection
16185670|NCT01504074|Behavioral|if needed (decided individually) either Acular eye drops, Ultracortenol eye drop or intravitreal triamcinolone injection|if prescribed: Ultracortenol/ Acular eye drops 3-4 times a day, if prescribed: singular intravitreal triamcinolone injection
16185671|NCT01504061|Other|Mederma N&I|Topical gel applied three times a day for eight weeks.
16185672|NCT01504061|Other|Mederma Ultra Gel|Topical gel applied once daily for eight weeks.
16185673|NCT01504048|Procedure|Colonoscopy with Indigo-Carmine Chromoendoscopy|Colonoscopy with chromoendoscopy using 0.2-0.5% Indigo-Carmine solution sprayed in five areas of the large intestine: Cecum, ascending colon, transverse colon, descending colon and rectum. Pictures are taken before and after dye-spraying and biopsies are collected from all segments of the large intestine and rectum.
16185674|NCT01504035|Device|Orthostat-L|Application of nx2g Lidocaine loaded hemostatic putty, i.e. Orthostat-L at the iliac crest bone graft harvest site
16185675|NCT01504035|Device|Orthostat|Application of nx2g hemostatic putty, i.e. Orthostat at the iliac crest bone graft harvest site
16185676|NCT01504022|Other|Telecare, selfmonitoring, lifestyl behaviour|Patients measure their own bloodpressure and the results are shown at a secured website after USB connection of the monitor to the computer. Patients receive medication adjustments and lifestyle advices via this secured website.
16185677|NCT01504009|Other|Muscle training|12 weeks of strength training 2-3 times/week
16185678|NCT01503996|Behavioral|alter drinking habits|if dehydration is apparent, more fluid intake is recommended
16185679|NCT01503983|Drug|Trastuzumab|Trastuzumab: 8 mg/kg day 1 followed by 6 mg/kg every 3 weeks (i.v.)
16185680|NCT01503983|Drug|Capecitabine|Capecitabine: 1000 mg/m2/12h/days 1 - 14 every 3 weeks (v.o.)
16185681|NCT01503983|Drug|Oxaliplatin|Oxaliplatin: 130 mg/m2 in 2 h, day 1 / (i.v.) /every 3 weeks
16185682|NCT01503970|Device|Arthroscopic matrix encapsulated chondrocyte implantation|Each implant of collagen scaffold contains approximately 6,000,000 autologous chondrocytes. This constructs of 10 mm diameter are implanted arthroscopically at the defect.
16185683|NCT01503957|Device|Nasya|Thixotropic nasal spray suspension, 2 sprays in each nostril
16185684|NCT01503957|Device|Saline solution|Nasal spray, 2 sprays in each nostril
16185685|NCT01503944|Drug|18F-AV-133|185 MBq
16185686|NCT01503944|Drug|18F-AV-45|185-370 MBq
16185687|NCT01503918|Drug|Valaciclovir/Aciclovir|2g valaciclovir, four times a day, enterally for 28 days, or until discharge from the critical care unit, but for a minimum of 14 days unless discharged from hospital. Those unable to receive enteral drugs will receive intravenous aciclovir 10mg/kg three times a day. Dosing modified in the presence of renal dysfunction.
16185688|NCT01503918|Drug|Valganciclovir/Ganciclovir|450mg valganciclovir, once a day, by enteral route. Treatment will continue for 28 days, or until discharge from the critical care unit, but for a minimum of 14 days unless discharged from hospital. Intravenous ganciclovir 2.5mg/kg once a day will be used if drugs cannot be given enterally. Treatment dosing will be modified for renal dysfunction
16185689|NCT01503905|Drug|Docetaxel|75mg/m2, iv injection, day1, every 21 days
16185690|NCT01503905|Drug|epirubicin|80mg/ m2, iv injection, day1, every 21 days
16185691|NCT01503905|Drug|cyclophosphamide|500 mg/m2, iv injection, day1, every 21 days
16185692|NCT01503905|Procedure|Modified radical mastectomy or breast-conserving Surgery|Two weeks after four cycles of neoadjuvant chemotherapy
16185693|NCT01503905|Drug|Docetaxel (post-operative)|Two weeks after surgery,75mg/m2, iv injection, day1, every 21 days, 4 cycles totally.
16185694|NCT01503905|Drug|Epirubicin (post-operative)|Two weeks after surgery, 80mg/m2,iv injection, day1, every 21 days, 4 cycles totally
16185695|NCT01503905|Drug|Cyclophosphamide (post-operative)|Two weeks after surgery, 500mg/m2, iv injection, day1, every 21 days, 4 cycles totally.
16185696|NCT01503905|Radiation|Radiation therapy|Two weeks after post-operative chemotherapy, perform radiation therapy based on 2011 NCCN guideline.
16185697|NCT01503905|Drug|Herceptin （post-operative)|Perform herceptin therapy (one year) based on 2011 NCCN guideline if the pathological test of the operative tumor sample showed HER2 positive.
16185698|NCT01503905|Drug|Tamoxifen (post-operative)|After radiation therapy, totally five years. Perform hormone therapy based on 2011 NCCN guideline if the tumor is ER/PR positive.
16185699|NCT01503892|Dietary Supplement|Metanx|Metanx- one tablet twice daily for twelve months
16185700|NCT01503892|Drug|Placebo|Placebo- one tablet twice daily for twelve months.
16185701|NCT01503866|Drug|bardoxolone methyl|oral, single dose
16185702|NCT01503840|Drug|sugammadex|sugammadex 10 mg/ml diluted solution dosage: 1mg/kg i.v. (0,1 ml/kg)
16185703|NCT01503840|Drug|Sodium chloride solution|Sodium chloride solution 0,9% dosage: 0,1 ml/kg i.v.
16185704|NCT01503827|Radiation|WBRT|A minimum of 30 Gy in 10 fractions given as one fraction per day within 4 weeks of randomisation
16185795|NCT01503164|Device|Positive Pressure Therapy (PAP)|Positive pressure therapy is the standard of care for managing obstructive sleep apnea. It entails wearing a mask that is connected to the PAP device which deliver pressure to the upper airway during sleep.
16185705|NCT01503814|Other|Simplified cardiovascular disease management|"This study is a complex pragmatic trial.The intervention includes a package of 4 main established measures for cardiovascular prevention and management:
~2 therapeutic lifestyle recommendations- smoking cessation (if applicable) and reduced salt consumption
~2 drug therapies (if applicable)- hydrochlorothiazide, 25mg tab, 1/2 tab daily (12.5mg/day) and aspirin, 25mg tab, 3 tabs daily (75mg/day)"
16185706|NCT01503801|Drug|Nitric Oxide|The infants in experimental group will receive inhale nitric oxide initiated at 5 ppm for 24 h followed by 2 ppm for 6 days or until weaning off
16185707|NCT01503801|Device|respiratory support|Routine respiratory support.
16185708|NCT01503788|Drug|Midazolam|participants will be given Midazolam IV 10-5 minutes prior to diagnostic lumbar puncture
16185709|NCT01503762|Other|Mirror therapy|mirror therapy
16185710|NCT01503762|Other|Classical rehabilitation techniques|splinting, tendon gliding, active range of motion, activities of daliy living
16185711|NCT01503749|Drug|G-colony stimulating factor|G-colony stimulating factor (5ug/kg/day)will be administered subcutaneously to three patients with liver cirrhosis of this arm.
16185712|NCT01503749|Other|Infusion of the mobilized monocyte cells|G-colony stimulating factor (5ug/kg/day)will be administered twice subcutaneously for 3 days to three patients with liver cirrhosis of this arm. On the day 4th, leukapheresis will be done to collect peripheral blood mononucleated cells. And then we are going to infuse the collected peripheral blood mononucleated cells of their own through the portal vein of each patients under ultrasonographic guidance.
16185713|NCT01503736|Drug|ferric citrate|0g/day ferric citrate capsule, TID for 56 days
16185714|NCT01503736|Drug|ferric citrate|4g/day ferric citrate capsule, TID for 56 days
16185715|NCT01503736|Drug|ferric citrate|6 g/day ferric citrate capsule, TID for 56 days
16185716|NCT01503723|Other|Determined by intended physician|We perform a prospective observational study. All the treatment for the patients are determined by intended physicians.
16185717|NCT01503684|Other|Determined by intended physician|We perform a prospective observational study. All the treatment for the patients are determined by intended physicians.
16185718|NCT01503671|Drug|Atorvastatin|Atorvastatin 40 mg/day
16185719|NCT01503658|Drug|Clopidogrel+Aspirin|Clopidogrel 75 mg, Aspirin 100 mg
16185720|NCT01503632|Behavioral|Behavioral Intervention|Receive intervention program
16185721|NCT01503632|Behavioral|Compliance Monitoring|Correlative studies
16185722|NCT01503632|Other|Laboratory Biomarker Analysis|Correlative studies
16185723|NCT01503632|Drug|Mercaptopurine|Given orally
16185724|NCT01503632|Other|Questionnaire Administration|Ancillary studies
16185725|NCT01503632|Procedure|Standard Follow-Up Care|Receive usual standard of care
16185726|NCT01503619|Other|laboratory biomarker analysis|Correlative studies
16185727|NCT01503606|Drug|Cefazolin|Cefazolin 1.0gm IVs q 12 hours after randomization for one week
16185728|NCT01503606|Drug|Clarithromycin|clarithromycin 500mg po bid after randomization for one week
16185729|NCT01503606|Drug|Cefazolin|Cefazolin 1.0gm IVs q 12 hours after randomization until delivery
16185730|NCT01503606|Drug|Clarithromycin|clarithromycin 500mg po bid after randomization until delivery
16185731|NCT01503593|Device|Calcium Phosphate, Calcium Sulphate|1cc of Calcium Phosphate and 1cc of Calcium Sulphate
16185732|NCT01503580|Drug|tolterodine, solifenacin|The enrolled women before March 2009 were treated with tolterodine 4 mg slow-release, and after March 2009 were treated with solifenacin 5 mg once a day for 12 weeks.
16185733|NCT01503567|Other|No treatment given|Subject will only fill out a questionaire
16185734|NCT01503554|Behavioral|Combined Social Worker and Pharmacist Program|"Physician or nurse performs a med rec during hospital stay Clinical pharmacist completes an additional med rec of home meds, assesses med-related risks, and provides education After discharge, a Master's prepared social worker contacts the patient and conducts an assessment from a psychosocial perspective to identify any unmet needs.
~Pharmacist will be available to patients should they have any medication-related questions post-discharge"
16185735|NCT01503554|Behavioral|No Intervention: Usual Care|Patient receives usual care upon discharge from the hospital.
16185736|NCT01503541|Genetic|DNA analysis|
16185737|NCT01503541|Genetic|RNA analysis|
16185738|NCT01503541|Genetic|gene expression analysis|
16185739|NCT01503541|Genetic|mutation analysis|
16185740|NCT01503541|Genetic|polymerase chain reaction|
16185741|NCT01503541|Other|laboratory biomarker analysis|
16185742|NCT01503528|Procedure|Motor Sparing Nerve Block|Continuous Motor sparing knee block (60mL of 0.5% ropivacaine with 10 mg Morphine, 30 mg Ketorolac and 150 mcg of epinephrine as the initial bolus) initiated in the preoperative period in the block room as per the standard practice and continued until discharge. Patients will be connected to an Ambit infusion pump in the postoperative period set to deliver ropivacaine 0.2% at a basal infusion rate of 7 mL/Hr with patient controlled boluses of 5mL every hour for breakthrough pain.
16185743|NCT01503528|Procedure|Peri-articular Catheters|3 peri-articular catheters inserted at the end of surgery followed by periarticular infiltration with ropivacaine 0.2% and wound infusions will be continued until discharge using elastomeric devices.
16185744|NCT01503515|Drug|Caspofungin Acetate|Given IV
16185745|NCT01503515|Drug|Fluconazole|Given IV or PO
16185746|NCT01503515|Other|Laboratory Biomarker Analysis|Optional correlative studies
16185747|NCT01503515|Drug|Voriconazole|Given IV or PO
16185748|NCT01503502|Drug|flumatinib|Flumatinib was supplied as 100 and 200 mg film-coated tablets for oral administration. Storage condition: 25°C, light proof, sealed.
16185749|NCT01503502|Drug|imatinib|Imatinib was supplied as 100 mg film-coated tablets. Storage condition: 25°C (77°F). Protected from moisture.
16185750|NCT01503489|Drug|Selective Serotonin Reuptake Inhibitors (SSRI), Serotonin-Norepinephrine Reuptake Inhibitor( SNRI), and Tricyclics.|Risk for antidepressant-associated switch from depression to hypomania, mania, or mixed episode during the 8 weeks after the introduction of an antidepressant or after increasing the dosage of baseline antidepressant.
16185751|NCT01503476|Device|Bravo® pH Monitoring System|Bravo pH monitoring
16185752|NCT01503476|Device|Bravo® pH Monitoring System|Bravo pH monitoring
16186218|NCT01500174|Device|ultraviolet therapy UV254|three times per week until wound closure or patient discharge from hospital
16185753|NCT01503463|Procedure|Home telemonitoring of patients with CHF|"Patients in the intervention group receive a personal 1-lead or 12-lead ECG recorder, a blood pressure monitor, a digital weight scale and appropriate education regarding the use of these devices. ThA trained nurse visits the patients weekly during the first month, and monthly thereafter, to confirm the appropriate use of the devices and services, to monitor symptoms, adherence to pharmacological and non-pharmacological treatment, and to complete the case record forms when necessary.
~If there is deterioration in the monitored vital signs, or if symptoms are reported, the allocated cardiologist is informed via the telehealth platform and has to decide whether the patient has to visit the hospital as in- or outpatient and whether the therapy has to be modified."
16185754|NCT01503450|Drug|Olanzapine OD Tablets 5 mg|Olanzapine OD Tablets 5 mg of Dr. Reddy's Laboratories Limited
16185755|NCT01503437|Drug|Olanzapine OD Tablets 5 mg|Olanzapine OD Tablets 5 mg of Dr. Reddy's Laboratories Limited
16185756|NCT01503424|Drug|Olanzapine|Olanzapine Tablets, 5 mg
16185757|NCT01503398|Drug|Olanzapine|Olanzapine Tablets, 5 mg
16185758|NCT01503385|Drug|Celecoxib|400 mg by mouth twice daily for for 5-7 days before beginning radiation therapy; continued 7 days per week throughout radiation treatment (about 6 weeks).
16185759|NCT01503372|Drug|Pazopanib|Adding Pazopanib to a standard chemotherapy consisting of FLO. 800 mg (2x400mg or 4x200mg) Pazopanib per day should be taken orally without food at least one hour before or two hours after a meal. Pazopanib will be given d1-14 each cycle (2 weeks cycles) with 12 cycles of chemotherapy FLO (d 1, each cycle). After 12 cycles chemotherapy FLO will be discontinued and Pazopanib will be given alone until disease progression
16185760|NCT01503372|Drug|5-FU, Oxaliplatin, Leukovorin (FLO)|Oxaliplatin 85 mg/m2 2h iv Leucovorin 200mg/m2 2h - iv FU 2600mg/m2 24h iv q2w for 12 cycles
16185761|NCT01503359|Dietary Supplement|Sarcosine|"Sarcosine group patients will receive 2 grams of sarcosine once a day in the morning for 6 months.
~Placebo group patients will receive 2 grams of placebo once a day in the morning for 6 months."
16185762|NCT01503346|Drug|DaHuang GanTsao Tang|"Intervention group
~2 grams of DaHuang abstract powder and 0.5 grams GanTsao abstract powder are mixed and separated into four packages;
~each package was given to each patient four times a day (three time after meal and one time before sleep);
~each patient received the usual medication of the hospice ward at the same time;
~record the patients' score of pre-test, mid-test and after-test of QIPCTP at the 1st day, the 3rd day and the 6th day;
~record the patients' score of EORTC QLQ-C30 V3.0 and ECOG (Eastern Cooperative Oncology Group Performance Status) at the 1st day and the 6th day."
16185763|NCT01503333|Behavioral|Physical activity intervention|Receiving individual counseling with the school nurse, tailored feedback from computer program, and after-school physical activity club.
16185764|NCT01503320|Dietary Supplement|Enteral glutamine|Dosage of glutamine: 0.57g/kg, ~ 30g/day= 3sachets
16185765|NCT01503320|Dietary Supplement|Placebo|Similar appearing nutritional supplement without glutamine.
16185766|NCT01503281|Other|Circuit training|Aerobic and resistance training exercises + Mediterranean diet
16185767|NCT01503268|Device|Implantation of implantable loop recorder|An implantable loop recorder (ILR) will be used to assess atrial fibrillation(AF) before and after DCCV or ablation, unless there is a pre-existing ILR or permanent pacemaker capable of continuous monitoring for occurrence of AF.
16185768|NCT01503268|Procedure|Percutaneous ablation of atrial fibrillation|Catheter-based percutaneous ablation of atrial fibrillation
16185769|NCT01503268|Procedure|Surgical ablation of atrial fibrillation|Minimally-invasive thoracoscopic surgical ablation of atrial fibrillation
16185770|NCT01503255|Behavioral|cognitive behavioral group therapy|6 weekly 90-minute group sessions
16185771|NCT01503255|Behavioral|health education group|6 weekly 90-minute group sessions
16185772|NCT01503242|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic peripheral blood stem cell transplantation
16185773|NCT01503242|Drug|Cyclosporine|Given PO
16185774|NCT01503242|Drug|Fludarabine Phosphate|Given IV
16185775|NCT01503242|Drug|Mycophenolate Mofetil|Given IV or PO
16185776|NCT01503242|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo allogeneic peripheral blood stem cell transplantation
16185777|NCT01503242|Radiation|Total-Body Irradiation|Undergo TBI
16185778|NCT01503242|Radiation|Yttrium Y 90 Anti-CD45 Monoclonal Antibody BC8|Given IV
16185779|NCT01503229|Drug|Abiraterone Acetate|Given by mouth
16185780|NCT01503229|Other|Laboratory Biomarker Analysis|Correlative studies
16185781|NCT01503229|Other|Pharmacological Study|Correlative studies
16185782|NCT01503229|Drug|Prednisone|Given PO
16185783|NCT01503216|Dietary Supplement|cholecalciferol|cholecalciferol, 2000 IU per day, 8 weeks
16185784|NCT01503216|Dietary Supplement|ergocalciferol|vitamin d2, 2000 IU per day for 8 weeks
16185785|NCT01503216|Dietary Supplement|Placebo|Placebo
16185786|NCT01503203|Other|Strength Training|It will be does three times per week. The exercises are: squat, single leg squat, leg extension, leg curl, chair adductor, chair abductor and double plantar flexion.
16185787|NCT01503203|Other|Core training|Exercises for trunk stabilization. Will be lateral, front and back bridges. It will be does three times per week with three sets between fifteen and third seconds.
16185788|NCT01503203|Other|Physical Virtual Training|The video game (Nintendo Wii and Wii Balance Board) will used for intervention. After strength and core training will be applied the physical virtual training during thirty minutes. Tho total time session for the Wii Group will be 110 minutes.
16185789|NCT01503203|Other|Strength Training|It will be does three times per week. The exercises are: squat, single leg squat, leg extension, leg curl, chair adductor, chair abductor and double plantar flexion.
16185790|NCT01503203|Other|Core Training|Exercises for trunk stabilization. Will be lateral, front and back bridges. It will be does three times per week with three sets between fifteen and third seconds.
16185791|NCT01503177|Biological|oncolytic measles virus encoding thyroidal sodium iodide symporter|Given intrapleurally
16185792|NCT01503177|Other|laboratory biomarker analysis|Correlative studies
16185793|NCT01503177|Procedure|single photon emission computed tomography|Correlative studies
16185794|NCT01503177|Procedure|computed tomography|Correlative studies
16186176|NCT01500421|Device|TH - Endovascular alone (Alsius®, Zoll, USA)|Patients are cooled with an endovascular (Alsius®, Zoll, USA) groin catether (9,3 french).
16185797|NCT01503151|Behavioral|Attention Bias Modification Treatment (ABMT)|Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns.
16185798|NCT01503151|Behavioral|Interpretation Bias Modification (IBM)|Interpretive Bias Modification Treatment (IBMT) using a computerized task modified to facilitate a more benign interpretation bias.
16185799|NCT01503151|Behavioral|Control Condition|Attention and interpretation training using a computerized tasks not intended to alter threat-related biases patterns.
16185800|NCT01503151|Behavioral|Attention and Interpretive biases modification (CBM)|Attention and interpretation training via computerized tasks intended to direct attention away from threat stimuli and to facilitate a more benign interpretation bias.
16185801|NCT01503138|Behavioral|Purpose-built intervention|A purpose-built intervention consists of: (i) Empowerment; (ii) Parenting workshops; and (iii) Telephone social support and Peer support.
16185802|NCT01503112|Other|No intervention, observational study|
16185808|NCT01503073|Device|tdcs (ELDITH, Neuroconn, Ilmenau, Germany)|transcranial direct current stimulation
16185809|NCT01503060|Behavioral|Educational video - Active|The active video will instruct parents in techniques related to optimal infant soothing.
16185810|NCT01503060|Behavioral|Educational Video - Sham|The sham video will provide general information about immunization immunization pain management.
16185811|NCT01503060|Drug|Sucrose Placebo (water)|Infants will receive 2mL of liquid on the tongue 2 minutes prior to vaccination
16185812|NCT01503060|Drug|Sucrose|Infants will receive 2mL of liquid on the tongue 2 minutes prior to vaccination
16185813|NCT01503060|Drug|Lidocaine Placebo|Infants will receive 1 g of cream to one or both injection site(s), as required, for 20-30 minutes prior to vaccination
16185814|NCT01503060|Drug|Lidocaine|Infants will receive 1 g of cream to one or both injection site(s), as required, for 20-30 minutes prior to vaccination
16185815|NCT01503047|Dietary Supplement|Tonalin®|Treatment consisted of exchanging the normal milk product consumed at breakfast for 200 ml of a skimmed milk with a lipid composition of 0.42 g saturated fatty acids (SFAs) and 0.72 g oleic acid, enriched with 3 g of a 1:1 mix of c9-t11 and t10-c12 (Tonalin®) (CLA group)
16185816|NCT01503047|Dietary Supplement|Placebo|Treatment consisted of exchanging the normal milk product consumed at breakfast for 200 ml of a skimmed milk with a lipid composition of 0.42 g saturated fatty acids (SFAs) and 0.72 g oleic acid, enriched with 3 g oleic acid (placebo)
16185817|NCT01503021|Drug|SFP|Dialysis with SFP administered via the liquid bicarbonate concentrate at a concentration of 2 µmoles (110 µg) iron/L of dialysate
16185818|NCT01503021|Other|Placebo|Dialysis with standard liquid bicarbonate concentrate without iron
16185819|NCT01503008|Device|Proteus Sustained Behavior Change system|The SBC system uses ingestible and wearable sensing devices and mobile phones to reinforce positive behaviors around medication usage, exercise and rest. Subjects will be taking their regularly prescribed oral hypoglycemics (metformin, sulfonylureas, thiazolidinediones, DPP-IV inhibitors, alpha-glucosidase inhibitors); glucometer
16185820|NCT01503008|Drug|Regularly prescribed diabetes medicines (metformin, sulfonylureas, thiazolidinediones, DPP-IV inhibitors, alpha-glucosidase inhibitors)|Oral hypoglycemics (metformin, sulfonylureas, thiazolidinediones, DPP-IV inhibitors, alpha-glucosidase inhibitors) at subjects' regularly prescribed doses; glucometer
16185821|NCT01502995|Device|Laser light (U-Step Walking Stabilizer with laser light)|Use of a laser light on a rolling walker during episodes of freezing of gait.
16185822|NCT01502982|Drug|R-CHOEP14x6+HD-AraC+HD-Mtx|rituximab 375 mg/m2 day 1 cyclophosphamide 750 mg/m2 day 1 doxorubicin 50 mg/m2 day 1 vincristine 1.4 mg/m2 day 1 etoposide 100mg/m2 days 1,2,3 Prednison 100 mg days 1,2,3,4,5 cycle repeated six times every two weeks followed by HD-AraC 3g/m2x4 and HD-mtx 3 g/m2 HD-AraC 3g/m2x4 times every 12 h
16185823|NCT01502969|Biological|Rotavin-M1|liquid, 10e6ffu/dose, 2 doses, 2 month interval
16185824|NCT01502969|Biological|cell culture medium in absence of virus|Placebo
16185825|NCT01502956|Device|InterStim® device|Eligible subjects will complete baseline assessments, be randomized and scheduled for first stage lead placement (FSLP) InterStim®. The criterion for an initial clinical response to InterStim® therapy will be defined as a ≥50% improvement in the mean number of UUIE/day on a minimum 3 day bladder diary, completed during the 7-14 days following the first stage lead placement (FSLP). Subjects with a ≥ 50% improvement mean number of UUIE/day will be eligible to proceed with implantation of the implantable pulse generator (IPG). Subjects will then be followed monthly to determine the response to therapy.
16185826|NCT01502956|Drug|Botox® injection|Eligible subjects will complete baseline assessments, be randomized and scheduled for Botox A® injection visit. Subjects who received a Botox A® injection will be assessed for a clinical response, at 1 month from injection, using the same clinical criterion (≥50% improvement in the mean number of UUIE/day on a 3 day bladder diary completed prior to the 1 month visit). Those subjects that experience a clinical response, at one month, will be eligible for a repeat Botox A® injection after 6 months, if they experience degradation of clinical effect, using the PGSC.
16185827|NCT01502943|Drug|Louxiangdan Tongxin granules|"TCM treatment:
~Decoction: Louxiangdan Tongxin granules Herbs:Danshen 10g、Chenxiang 1g、Gualou10g、Xiebai 10g、Banxia6g、Chuanxiong 6g 、Dangshen 10g、Zhiqiao 6g、Taoren 10g、Guizhi 6g Therapeutic Principle:Invigorating Spleen to Remove Phlegm and activating blood and dissolving stasis, at least 6 kinds of TCM herbs can be chosen and their dosages be adjusted according to Syndrome Differentiation.
~Usage:Once 100ml, twice per day after breakfast and supper."
16185828|NCT01502943|Drug|TCM granules placebo|Chinese medicine granules placebo: once 100ml, twice per day after breakfast and supper.
16185883|NCT01502605|Drug|5-Aminolevulinic Acid|A one time, single-dose administration of ALA is planned 4 hours pre-operatively the day of surgery. ALA will be mixed in the minimum volume of sterile water or juice immediately before use and given as a single oral bolus. Once ALA has been administered, patients will be kept in subdued lighting away from sunlight.
16186217|NCT01500187|Device|Pediagel|1.23% Acidulated Phosphate Fluoride Gel
16185829|NCT01502943|Drug|Chixiangshen Tongxin granules|"TCM treatment:
~Decoction: Chixiangshen Tongxin granules Herbs: Chishao 10g, Chenxiang 1g, Danggui 10g, Jupi 10g, Yanhusuo 6g, Chuanxiong 6g, Dangshen 10g, Huangqi 6g, Taoren 10g, Honghua 10g Therapeutic Principle:Invigorating Spleen to Replenish Qi and activating blood and dissolving stasis, at least 6 kinds of TCM herbs can be chosen and their dosages be adjusted according to Syndrome Differentiation.
~Usage:Once 100ml, twice per day after breakfast and supper."
16185830|NCT01502943|Drug|TCM granule placebo plus western basis treatment|Chinese medicine granules placebo: once 100ml, twice per day after breakfast and supper.
16185831|NCT01502943|Drug|Western basis treatment|Aspirin: 100mg pd. P.O.( patients who have Aspirin resistance or Allergy can replaced with Piece clopidogrel 75mg pd. P.O.) Atorvastatin calcium (Lipitor): 10mg pd. P.O.( patients who have Atorvastatin calcium resistance or Allergy can replaced with Additive amount of pravastatin equal to 10mg Lipitor) Nitroglycerin: sublingual necessary.
16185832|NCT01502930|Behavioral|IRT|Internet-based IRT with therapist support during 6 weeks
16185833|NCT01502930|Behavioral|Stress Reduction|Internet-based stress reduction with therapist support during 6 weeks
16185834|NCT01502917|Drug|Radioactive iodine-labeled monoclonal antibody omburtamab|Prior to treatment children will be pre-medicated with super-saturated potassium iodide & liothyronine to prevent thyroid uptake of the therapeutic radioisotopes. The proposed intervention is a surgical procedure using interstitial infusion of the radiolabeled monoclonal antibody 124I-omburtamab into the brain stem tumor. This will be performed by stereotactic placement of a small caliber infusion cannula into the tumor followed by a slow infusion (CED) of 124I-omburtamab. Following treatment, these children will be monitored during inpatient hospitalization with clinical evaluations & PET/CT or PET/MRI scans of the brain & other organs. Clinical observations, intensive care unit monitoring, routine blood & interval imaging studies (MRI & PET/CT or PET/MRI scans) will be performed at predetermined time points. If the PET/CT scan happens to fall on a weekend or holiday, the scan may be done before or after at the discretion of the Study PI. This will not affect dosimetry interpretation.
16185835|NCT01502917|Radiation|External Beam Radiotherapy|Standard radiation therapy is given 4-6 weeks prior to study entry.
16185836|NCT01502904|Device|Sirolimus-eluting stent|2x2 randomization by the treatment of dyslipidemia and hypertension(In patients of dyslipidemia: pitavastatin 2mg/day vs. pravastatin 20mg/day, in patients of hypertension: eporsartan 600mg/day vs. Non-ARB) and the types of the implanted DES, SES vs BES.
16185837|NCT01502904|Device|Biolimus-eluting stents|2x2 randomization by the treatment of dyslipidemia and hypertension(In patients of dyslipidemia: pitavastatin 2mg/day vs. pravastatin 20mg/day, in patients of hypertension: eporsartan 600mg/day vs. Non-ARB) and the types of the implanted DES, SES vs BES.
16185838|NCT01502904|Drug|pravastatin 20mg/day after DES implantation|2x2 randomization by the treatment of dyslipidemia and hypertension(In patients of dyslipidemia: pitavastatin 2mg/day vs. pravastatin 20mg/day, in patients of hypertension: eporsartan 600mg/day vs. Non-ARB) and the types of the implanted DES, SES vs BES.
16185839|NCT01502904|Drug|pitavastatin 2mg/day after DES implantation|2x2 randomization by the treatment of dyslipidemia and hypertension(In patients of dyslipidemia: pitavastatin 2mg/day vs. pravastatin 20mg/day, in patients of hypertension: eporsartan 600mg/day vs. Non-ARB) and the types of the implanted DES, SES vs BES.
16185840|NCT01502904|Drug|Non-ARB /day after DES implantation|2x2 randomization by the treatment of dyslipidemia and hypertension(In patients of dyslipidemia: pitavastatin 2mg/day vs. pravastatin 20mg/day, in patients of hypertension: eporsartan 600mg/day vs. Non-ARB) and the types of the implanted DES, SES vs BES.
16185841|NCT01502904|Drug|Eposartan 600mg/day after DES implantation|2x2 randomization by the treatment of dyslipidemia and hypertension(In patients of dyslipidemia: pitavastatin 2mg/day vs. pravastatin 20mg/day, in patients of hypertension: eporsartan 600mg/day vs. Non-ARB) and the types of the implanted DES, SES vs BES.
16185842|NCT01502891|Other|Decision Aid|The decision aid, Depression Medication Choice, uses plain language and is designed to enhance patient understanding and satisfy the International Patient Decision Aid Standards (IPDAS) requirements for a safe and unbiased decision aid.
16185843|NCT01502878|Dietary Supplement|Nut challenge|Nut powder made from non-roasted nuts and roasted banana mixed with oats yoghurt or chocolate pudding
16185844|NCT01502878|Dietary Supplement|Nut challenge: Placebo|Dried banana mixed with oat yoghurt or chocolate pudding
16185845|NCT01502878|Dietary Supplement|Nut oral desensitization|Roasted peanut powder mixed with milk- and soy-free margarine
16185846|NCT01502839|Other|No Intervention|This retrospective data analysis will rely on data obtained from chart review.
16185847|NCT01502826|Dietary Supplement|standardized mixed meal|All participants will undergo a mixed meal test (300 kcal/m2 of body surface area, 53.8% carbohydrates, 29.5% lipids, 16.7% proteins) and will be monitored for 300 minutes thereafter.
16185848|NCT01502813|Drug|Citicoline, Omega-3 Fatty Acids and Creatine|Citicoline: 500 mg/day for 28 days Omega-3 Fatty Acids: 2 g/day for 28 days Creatine: 5 g/day for 28 days
16185849|NCT01502800|Drug|ARQ 761|ARQ 761 will be administered intravenously at a starting dose of 195 mg/m2 IV once weekly. Depending on toxicities observed, up to seven treatment cohorts will be enrolled with dose escalation occurring by doubling (first escalation) and 40% increments thereafter. If dosing is tolerated at all levels and pharmacokinetic data suggest continued escalation is warranted, additional dose levels will
16185850|NCT01502800|Drug|ARQ 761 Weekly Administration|"If you decide to participate in this study ARQ 761 (beta lapachone) will be given to you through your vein once a week via a Portacath or Hickman line (a device that will make it easier to access your central vein that will be placed under your skin in your upper chest)
~You will receive the same dose of ARQ761 each week for 8 weeks. The total infusion time will be determined by your physician, it may be either 2 or 3 hours.
~The beginning dose level will be 390 mg/m2."
16185851|NCT01502800|Drug|Bi-Weekly Administration of ARQ 761|"If you decide to participate in this study ARQ 761 (beta lapachone) will be given to you through your vein bi-weekly via a Portacath or Hickman line (a device that will make it easier to access your central vein that will be placed under your skin in your upper chest)
~You will receive the same dose of ARQ761 bi-weekly for 8 weeks. The total infusion time will be determined by your physician, it may be either 2 or 3 hours.
~The beginning dose level will be 390 mg/m2."
16185884|NCT01502592|Procedure|Cryoablation|"OncCore Biopsy (+ Cryo) Date*
~Pre- and post- cryo MRI
~Core biopsy x ≥3
~Cryoablation Optional pre-surgery MRI day prior or day of Mastectomy Date* Safety assessment 30 (+/-10) days after surgery research bloods 30 (+/-10) days after surgery.*"
16185852|NCT01502800|Drug|Two Consecutive Weeks Administration of ARQ 761 with one week of rest|"If you decide to participate in this study ARQ 761 (beta lapachone) will be given to you through your vein once a week via a Portacath or Hickman line (a device that will make it easier to access your central vein that will be placed under your skin in your upper chest)
~You will receive the same dose of ARQ761 for 2 consecutive weeks followed by one week of rest for 6 weeks. The total infusion time will be determined by your physician, it may be either 2 or 3 hours.
~The beginning dose level will be 390 mg/m2."
16185853|NCT01502787|Drug|Metoprolol succinate|The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.
16185854|NCT01502787|Drug|Nebivolol|The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.
16185855|NCT01502787|Procedure|Forearm blood flow|Using high-resolution ultrasound, investigators will measure skeletal muscle blood flow in the forearm at rest, following handgrip exercise (described below), and following Angiotensin II infusion (described below).
16185856|NCT01502787|Procedure|Microneurography|Investigators will measure sympathetic nerve activity from the peroneal nerve by inserting a tiny needle directly into the nerve in the leg. Investigators will localize the nerve by electrical stimulation over the skin using a blunt probe. With this stimulation, subject will notice either involuntary twitching or a tingling sensation, which may be annoying but not painful. Investigators will then introduce a tiny, sterile wire needle (an electrode) through the skin at the same location. When the tip of the needle enters the nerve, subjects may again notice involuntary muscle twitches or tingling in the leg. Investigators will then turn the electrical stimulator off and make minor adjustments in the position of the needle until investigators begin to record the nerve signals. The recording needle will remain in position throughout the study.
16185857|NCT01502787|Procedure|Rhythmic handgrip exercise|Subjects will perform a rhythmic handgrip exercise at 30% of maximal voluntary contraction for 3 minutes. Investigators will measure cardiac output (non-invasive impedance plethysmography), blood pressure, and sympathetic nerve activity (SNA) at baseline and following this handgrip exercise.
16185858|NCT01502787|Procedure|Lower body negative pressure|Lower body negative pressure increases sympathetic nerve activity. Therefore, investigators will measure cardiac output (non-invasive impedance plethysmography), blood pressure and sympathetic nerve activity at baseline and after rhythmic handgrip exercise plus lower body negative pressure (LBNP) for 2 minutes.
16185859|NCT01502787|Drug|Angiotensin II|Investigators will measure cardiac output (non-invasive impedance plethysmography), blood pressure and sympathetic nerve activity at baseline and during intravenous infusion of Angiotensin II at the dose of 1, 2, and 3 ng/kg/min for 15 minutes at each dose.
16185860|NCT01502774|Drug|Injection of Cyclosporin|one single intravenous bolus injection of 2.5 mg/Kg
16185861|NCT01502774|Drug|Placebo|One single intravenous bolus injection of Placebo
16185862|NCT01502774|Procedure|Echocardiography|1 year after AMI
16185863|NCT01502761|Drug|Magnesium Sulfate|Intra-arterial
16185864|NCT01502748|Other|endovascular sampling|Paired sampling from the distal arterial(endovascular catheter) and peripheral venous (femoral sheath) locations: withdrawal of 3ml of blood from vasculature distal to the occlusive thrombus
16185865|NCT01502735|Biological|DENV-1 PIV, 2.5 µg|2.5 µg Purified Inactivated Virus (PIV) in a volume of 0.5 mL administered via intramuscular injection on Study Days 0, and 28 (±4 days)
16185866|NCT01502735|Biological|DENV-1 PIV, 5 µg|5 µg Purified Inactivated Virus (PIV) in a volume of 0.5 mL administered via intramuscular injection on Study Days 0, and 28 (±4 days)
16185867|NCT01502722|Behavioral|Effect of ingestion sugary and sweetened drinks on thirst|The participants will drink Water (control group), Decarbonized Pineapple Soda (11% sugar)and Decarbonized Pineapple Diet Soda (1% Sugar and Sucralose). The beverages will be presented chilled but without ice in 500 ml portions in opaque plastic containers and participants will be asked to consume the entire amount within 15 min. The beverages will be tested previously in laboratory in order to obtain their pH and osmolality.
16185868|NCT01502709|Device|Caloric Vestibular Neurostimulation|1 treatments of caloric vestibular neurostimulation for 7.5 minutes in the right ear
16185869|NCT01502709|Device|placebo|Matching placebo device
16185870|NCT01502696|Biological|PEG IFN alfa-2b|3µg/kg weekly injections
16185871|NCT01502683|Procedure|No aortic clamping|No aortic clamp used in this group. The aortic clamp is a standard cardiac surgical instrument used during cardiac operations, not a specific device used for this study.
16185872|NCT01502683|Procedure|partial occluding clamp|The partial-occluding clamp is a standardized instrument used during coronary artery bypass surgery, it is not a specific device for this study.
16185873|NCT01502683|Procedure|single cross clamp|The proximal anastomoses performed under single clamp is an alternative method during coronary artery bypass surgery. The single clamp essentially means that whole operation is done using the cross clamp, which is a standard instrument during cardiac operations, not a specific device for this study.
16185874|NCT01502683|Procedure|cross clamp and partial occluding clamp|Both an aortic cross clamp and partial occluding clamp are used in this arm. Neither the cross clamp nor the partial clamp are specific devices for this study but are standard cardiac surgical instruments used during coronary artery bypass surgery and cardiac surgery.
16185875|NCT01502670|Drug|18F-FACBC Radiotracer|Test radiotracer uptake in lung nodule
16185876|NCT01502657|Device|Ultrasonography (EnVisor Philips Medical Systems)|Percutaneous tracheostomy is performed using the dilatational method with ultrasonography guidance;
16185877|NCT01502644|Drug|Oxycodone|Daily dosage up to 120 mg
16185878|NCT01502644|Drug|Morphine|Daily dosage up to 90 mg immediate release or 180 mg extended release
16185879|NCT01502644|Drug|Placebo|Placebo-matching oxycodone, placebo-matching morphine
16185880|NCT01502631|Drug|SUN13837 injection|SUN13837 injection, injection 1 x daily for 28 doses
16185881|NCT01502631|Drug|Placebo|Matching placebo, volume equivalent to injection 1 x daily for 28 doses
16185882|NCT01502618|Behavioral|Focus Group|N/A. Protocol is the focus group
16186288|NCT01499641|Drug|Methylprednisolone|Epidural methylprednisolone 40 mg or none
16185885|NCT01502592|Biological|Ipilimumab|"Ipilimumab Appt. with Med Onc Ipilimumab administered Core Biopsy Date*
~MRI
~Core biopsy x ≥3 Optional pre-surgery MRI biopsy prior or day of Mastectomy Date* Safety assessment 2-3 weeks post-mastectomy (co-ordinated with off-study surgery follow-up appt if feasible) and then every 2-3 weeks thereafter until at least 12 weeks post ipilimumab date. # Research bloods 30 (+/-10) days after surgery."
16185886|NCT01502566|Behavioral|Education Intervention|Children/mothers allocated to this arm will receive an pamphlet with key information on dental caries prevention, together with oral instructions about how to avoid dental caries.
16185887|NCT01502553|Device|Comparison Test to Yuyue Medical BP Meter, YYBP-212|DUT: Transtek Blood Pressure Monitor, LS-802. Reference Device: Yuyue Medical Blood Pressure Meter, YYBP-212, accuracy: ±1mmHg and range: 0-300mmHg.
16185888|NCT01502527|Dietary Supplement|Femarelle|Twice daily oral treatment with Femarelle
16185889|NCT01502514|Procedure|Fat Harvesting and Implantation of Adipose Derived Stem Cells|Local Liposuction will be performed to harvest the fat. The Adipose Derived Stem Cells will be implanted via intramyocardial injection and intravenously.
16185890|NCT01502501|Procedure|Harvesting and Implantation of Adipose-Derived Stem Cells (ASCs)|Local liposuction procedure to harvest the fat tissue. Adipose Derived Stem Cells are then implanted via intramyocardial and intravenous injection.
16185891|NCT01502488|Procedure|Fat Harvesting and Stem Cell Injection|Cells will be harvested through a local liposuction and injected via IV delivery
16185892|NCT01502449|Behavioral|DESTRESS-T|Usual primary care PTSD treatment, plus a telephone care management program that includes: four outreach calls, feedback to the treating primary care provider, and care coordination
16185893|NCT01502449|Other|Optimized Usual Care (OUC)|Optimized Usual Care is usual primary care PTSD treatment, plus a telephone care management program that includes: four outreach calls, feedback to the treating primary care provider (PCP), and care coordination.
16185894|NCT01502423|Biological|Adalimumab|Subcutaneously 40 mg every other week (eow) or every week (ew) (as dosing requires)
16185895|NCT01502410|Drug|sorafenib tosylate|Given PO dosage 200 mg/m2/dose (max dose:400 mg/dose) given every 12 hours on days 1-28
16185896|NCT01502410|Other|pharmacological study|Optional correlative studies
16185897|NCT01502410|Other|laboratory biomarker analysis|Optional correlative studies
16185898|NCT01502384|Other|neurological examination|motor and cognitive functions
16185899|NCT01502371|Drug|Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 25 mcg|MF MDI 25 mcg (per inhalation), 2 puffs BID for 12 weeks
16185900|NCT01502371|Drug|Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 50 mcg|MF MDI 50 mcg (per inhalation), 2 puffs BID for 12 weeks
16185901|NCT01502371|Drug|Mometasone Furoate (MF) Metered Dose Inhaler (MDI), 100 mcg|MF MDI 100 mcg (per inhalation), 2 puffs BID for 12 weeks
16185902|NCT01502371|Drug|Mometasone Furoate (MF) Dry Powder Inhaler (DPI), 100 mcg|MF DPI 100 mcg (per inhalation), 1 puff QD for 12 weeks
16185903|NCT01502371|Drug|Placebo Metered Dose Inhaler (MDI)|Placebo MDI, 2 puffs BID for 12 weeks
16185904|NCT01502371|Drug|Placebo Dry Powder Inhaler (DPI)|Placebo DPI, 1 puff QD for 12 weeks
16185905|NCT01502358|Biological|Tetravalent Dengue Vaccine (TVDV)|Low dose delivered intramuscularly on Study Days 0, 30 and 90
16185906|NCT01502358|Biological|Tetravalent Dengue Vaccine (TVDV) with Vaxfectin® (low-dose)|Low dose: TVDV formulated with Vaxfectin®; 1.0 mL volume delivered intramuscularly on Study Days 0, 30 and 90
16185907|NCT01502358|Biological|Tetravalent Dengue Vaccine TVDV with Vaxfectin® (High Dose)|High dose: TVDV formulated with Vaxfectin®; 1.0 mL volume delivered intramuscularly on Study Days 0, 30 and 90
16185908|NCT01502345|Biological|Vaccine/device combination for prevention of HFRS|PUUV DNA Vaccine, 2.0mg/ml TDS-IM injection HTNV DNA Vaccine, 2.0 mg/ml TDS-IM injection HTNV + PUUV Vaccine mixture, 1.0mg/mL + 1.0mg/ml TDS-IM injection
16185909|NCT01502332|Other|Intensive Alveolar Recruitment|Recruitment with opening pressures of 45 cmH2O in the airways, followed by ventilation with PEEP = 13 cmH2O, during 4 hours of protective mechanical ventilation with tidal volume (VT) = 6 mL/kg/pbw.
16185910|NCT01502332|Other|Moderate Alveolar Recruitment|Recruitment with opening pressures of 20 cmH2O in the airways, followed by ventilation with PEEP = 8 cmH2O, during 4 hours of protective mechanical ventilation with VT = 6 mL/kg/pbw.
16185911|NCT01502319|Behavioral|Cognitive therapy|Interventional studies conducted by the consortium focus on a range of cognitive and cognitive-behavioral techniques including cognitive therapy.
16185912|NCT01502306|Behavioral|Telephone counseling|Telephone counseling is conducted in the appropriate language (Spanish and English) by counselors at the California Smokers' Helpline. Counselors use a structured protocol and there is a record for each call. Quantitative information that will be available for analysis include: timing, length, and frequency of counseling calls.
16185913|NCT01502306|Drug|Nicotine patches|Clients will be screened for contraindications to nicotine patch use, and a doctor's approval will be necessary before patches are sent if a contraindication exists.
16185914|NCT01502306|Behavioral|Incentive|They will be given their choice of gift cards from one of 4 major business chains: Wal-Mart, Target, Vons/Safeway, or Ralph's/Kroger card.
16185915|NCT01502293|Biological|Tavokinogene Telseplasmid (tavo)|Patients received intratumoral injection(s) of tavo.
16185916|NCT01502293|Device|OncoSec Medical System (OMS)|Electroporation via OMS was performed immediately following intratumoral injection of tavo. A sterile applicator containing 6 stainless steel electrodes arranged in a circle were placed around the tumor. The applicator was connected to the OMS power supply and six pulses were administered to each tumor lesion at the approximate point of tavo injection.
16185917|NCT01502280|Drug|5-Aminolevulinic acid (ALA)|Following informed consent, within 3 hours prior to surgery, patient will orally ingest [or be given via Nasogastric (NG), Orogastric (OG), or Gastric tube (G-tube)] either (1) 5-ALA/Gliolan® mixed with sterile water (20mg/kg)
16185918|NCT01502280|Drug|Placebo - ascorbic acid|Within 3 hours prior to surgery, patient will orally ingest [or be given via Nasogastric (NG), Orogastric (OG), or Gastric tube (G-tube)] 1.5 Gm. placebo - ascorbic acid in 50 ml sterile water.
16185919|NCT01502267|Drug|High dose IVIG and B cell depleting agents|"IVIG(2g/kg two times on day 1, 30)
~Rituximab(375mg/m2 on day 3)
~Bortezomib(1.3mg/m2 four times on day 31, 34, 38, 41)"
16185976|NCT01501877|Behavioral|Standard smoking cessation intervention|Standard smoking cessation intervention based on clinical practice guidelines.
16185920|NCT01502254|Other|audio recorded information|Access to the audio recorded information about the clinical trial the patient was information about and asked to consider. A copy of the audio recording is given to the patients directly after the clinical visit.
16185921|NCT01502241|Drug|Temozolomide|100 mg/m2 per day on seven out of fourteen days.
16185922|NCT01502241|Radiation|Radiotherapy of the partial brain.|60 Gy in 30 fractions à 2 Gy.
16185923|NCT01502228|Drug|150-Water|Patients will be imaged immediately before, and between 14-28 days after initiation of Sunitinib therapy, in the single bed position using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 15O-water at 50 mCi/dose, IV.
16185924|NCT01502228|Drug|62Cu-ethylglyoxal bis|Imaging with 62Cu-ETS will be done immediately following imaging with 150-water. Patients will be imaged immediately before, and between 14-28 days after, initiation of Sunitinib therapy using the Siemens Biograph 64 TruePoint system located in the clinical facilities of the I.U. Cancer Center. Administer 62Cu-ETS in the range of 20-25 mCi/Dose, IV.
16185925|NCT01502228|Procedure|Positron Emission Tomography|PET Scan
16185926|NCT01502228|Drug|Sunitinib|
16185927|NCT01502215|Other|Red blood cell transfusion|Red blood cell (RBC) transfusion will be given when hemoglobin fall below 9 g/dL since ICU admission until the discharge of intensive care unit. Following administration of the 1 RBC unit, a repeat hemoglobin levels is performed;if a patient's hemoglobin is 9 g/dL or higher, no additional transfusion is necessary.
16185928|NCT01502215|Other|Red blood cell transfusion|Red blood cell (RBC) transfusion will be only given when hemoglobin fall below 7 g/dL since ICU admission until the discharge of intensive care unit. Following administration of the 1 RBC unit, a repeat hematocrit is performed;if a patient's hemoglobin 7 g/dL or higher, no additional transfusion is necessary
16185929|NCT01502202|Drug|Gefitinib|Gefitinib 250mg, per PO. daily, D 5-18 (during 14 days)
16185930|NCT01502202|Drug|Placebo|Placebo 1 tablet, per PO, Daily on D 5-18 (during 14 days)
16185931|NCT01502202|Drug|Pemetrexed plusCIsplatin|Pemetrexed 500mg/m2 on D1 plus Cisplatin 75mg/m2 on D1 every 3 weeks maximum 9 cycles
16185932|NCT01502189|Other|Representational approach|The Representational approach as described in the detailed description. Each participating parent receives three rounds that consist of two meetings. Each round starts with a meeting where the parent identifies an area where he/she needs more information. The nurse and the parent jointly survey the parent's representation of the area and discusses consequences of knowledge gaps or misunderstandings. Then, new information is introduced and benefits from the new information is discussed. After some days, a follow-up meeting takes place.
16185933|NCT01502163|Device|Thermoflect [TM] passive insulation|passive insulation in the preoperative phase, befor induction of anesthesia
16185934|NCT01502163|Device|Active prewarming (Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL)|Prewarming Thermoflect™/Mistral Air™, TSCI, Amersfoort, NL before induction of anesthesia
16185935|NCT01502150|Other|Data Collection|Information collected from follow-up visits post proton radiation therapy yearly or more often, and test results for at least 10-15 years.
16185936|NCT01502150|Other|Dose Distribution Data Collection|Data collection of complete plan information, including dose distribution, beam configuration and images, computed tomography (CT) images acquired on multiple days and 4D CT's for respiratory correlated imaging.
16185937|NCT01502137|Drug|somatropin|Injected subcutaneously, 50 mcg/kg/day (up to a maximum of 4 mg/day) once daily. Additional dose administered during dialysis. In total, patients will receive 8 doses.
16185938|NCT01502137|Drug|somatropin|Injected subcutaneously, 50 mcg/kg/day (up to a maximum of 4 mg/day) once daily. Additional dose administered during dialysis. In total, subjects will receive 7 doses.
16185939|NCT01502124|Drug|somatropin|Injected subcutaneously 7 times per week after reconstitution with liquid buffer prior to use. Dose level of 0.024-0.050 mg/kg at the discretion of the practicing paediatric endocrinologists
16185940|NCT01502124|Drug|somatropin|Injected subcutaneously 7 times per week. Dose level of 0.024-0.050 mg/kg at the discretion of the practicing paediatric endocrinologists
16185941|NCT01502098|Procedure|Postoperative early passive motion|Shoulder exercises starting on the first postoperative day
16185942|NCT01502098|Other|Sling|Sling for 4 weeks
16185943|NCT01502085|Drug|Vorinostat, Lenalinomide and Dexamethasone|"Vorinostat: 400 mg po days 1-7 and 15-21 Lenalidomide: 25 mg po days 1-21
~* Lenalidomide dose for patients with renal impairment (CrCL<50ml/min) has be dose adjusted according to package insert
~Dexamethasone: 40mg po days 1, 8, 15 and 22 for patients aged less than 75 years, 20mg for those aged 75 years and above"
16185944|NCT01502072|Drug|Ribavirin|Modified schedule of 60 milligrams/milliliter for 3-hour period 3 times/day for at least 5 days by aerosolization via a SPAG-2 generator via a face mask.
16185945|NCT01502072|Drug|Ribavirin|One time loading dose of 10 mg/kg oral dose then 20 mg/kg orally (rounded to the nearest 200 mg dose) divided into three doses per day (max 1800 mg/day).
16185946|NCT01502059|Other|Pilates|Pilates training - twice a week (one hour per class) during 90 days
16185947|NCT01502046|Drug|delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)|Sativex 2.7 mg delta-9-tetrahydrocannabinol/2.5 mg cannabidiol Oromucosal Spray. One spray per day, up to a maximum of 12 sprays per day.
16185948|NCT01502046|Drug|Placebo|Placebo, One spray per day, up to a maximum of 12 sprays per day.
16185949|NCT01502033|Device|Transcranial Magnetic Stimulation|30 daily treatments of (over 6-8 weeks) of 10 Hz rTMS at 120% motor threshold, applied to the left dorsolateral prefrontal cortex with 3,000 stimulations per treatment
16185950|NCT01502020|Drug|imiquimod cream, 3.75%|Dosage form: Topical Cream Dosage: 3.75% Frequency: The assigned test article was to be applied once daily for two 2-week treatment cycles separated by a 2-week no treatment interval Duration of Treatment: Two 2-week treatment cycles separated by a 2-week no-treatment period and an 8-week follow-up period.
16185951|NCT01502020|Drug|Vehicle Cream|Dosage form: Topical Cream Dosage: Placebo Frequency: The assigned test article was to be applied once daily for two 2-week treatment cycles separated by a 2-week no treatment interval Duration of Treatment: Two 2-week treatment cycles separated by a 2-week no-treatment period and an 8-week follow-up period.
16185952|NCT01502020|Drug|imiquimod cream, 3.75%|Dosage form: Topical Cream Dosage: 3.75% Frequency: The assigned test article was to be applied once daily for two 2-week treatment cycles separated by a 2-week no treatment interval Duration of Treatment: Two 2-week treatment cycles separated by a 2-week no-treatment period and an 8-week follow-up period.
16185953|NCT01502007|Other|Accelerometer feedback and lifestyle counseling|Subjects will meet with the exercise counselor who will use accelerometer data to provide feedback and counseling to help the user increase their activity by at least 20% each day. In subjects who achieve an increase of 20%, the counseling will focus either on maintaining activity levels or increasing activity further depending on the desire of the subject. Counseling will be provided once weekly by phone and in person at least once a month. Following the 26th week the experimental subjects will continue to wear the Fitbit and receive feedback about their activity levels for an additional 24 weeks, but they will no longer receive counseling. The control group will receive no counseling for the first 26 weeks of the study and will then crossover to get accelerometry feedback and counseling for the last 24 weeks of the study.
16185954|NCT01502007|Other|Accelerometer without Feedback|The accelerometer, Fitbit, will be worn continuously. Fitbit can provide feedback to subjects about their physical activity. Subjects will wear the Fitbit for two weeks (without feedback) to obtain baseline activity data. The experimental group will then be instructed on use of the fitbit. This group will receive feedback from the accelerometer for the remainder of the study. The control group will wear the Fitbit but receive no feedback for the first 26 weeks of the study. For the last 24 weeks they will crossover and receive feedback from the Fitbit accelerometer.
16185955|NCT01501994|Other|GRUVE accelerometer (MUVE, inc.)|Physicians in the experimental group will be given an accelerometer for 2 weeks (without feedback) prior to starting the study and will continue to have their activity monitored for the duration of the study. The accelerometer monitors movement and accurately estimates physical activity energy expenditure. They will receive feedback about their activity for the remainder of the trial. Physicians in the control group will wear the accelerometer but not receive feedback for the first 14 weeks of the trial. They will receive feedback for the last 12 weeks of the trial as they crossover to the experimental group.
16185956|NCT01501994|Other|walking workstation|The physicians in the experimental group will be provided with a walking workstation. The walking workstation has a computer keyboard, computer monitor and telephone attached to an exercise treadmill (assembled by the investigators). This allows the user to walk at 1 mile per hour while dictating, typing, responding to e-mail, etc. The treadmill can be placed in an examining room if the physician wishes to use it while dictating notes or it can be placed in a separate office. For the last 12 weeks of the study the experimental group will not use the walking workstation while the control grop will use the workstation (crossover).
16185957|NCT01501994|Procedure|exercise counseling|After the first two weeks of baseline data collection, the experimental group will receive exercise counseling for the next 12 weeks. They will be advised to make use of the accelerometer and the walking workstation as well as how to increase their activity in other ways. This group will not receive exercise counseling for the last 12 weeks of the study while the control group will cross over and receive exercise counseling for the last 12 weeks of the study (the control group will not receive exercise counseling for the first 14 weeks of the study).
16185958|NCT01501968|Drug|Colistin|Colistimethate sodium 2.5-5mg/kg iv per day
16185959|NCT01501968|Drug|Colistin + Ascorbic acid|Colistimethate sodium 2.5-5mg/kg iv per day and ascorbic acid 2 grams iv q 12 hours
16185960|NCT01501955|Device|Metaphyseal Hip Prosthesis|Metaphyseal Hip Prosthesis (MHP) hip replacement
16185961|NCT01501955|Device|Stanmore|Stanmore hip prosthesis
16185962|NCT01501942|Drug|AIM-102, D-cyclohexylalanine-D-glutamic-glycine tripeptide|AIM-102 is supplied as an oral solution. Dose is 15 mg of AIM-102 per kg of patient weight measured on Treatment Day 1 of each treatment phase The study drug will be administered for 4 consecutive days with at least a 2 week wash-out period prior to crossing over to the alternative treatment for 4 days.
16185963|NCT01501942|Drug|Buffered Saline|The matching placebo is an oral solution of phosphate buffered saline
16185964|NCT01501929|Drug|Metoprolol succinate|The subject will be started on metoprolol succinate (Toprol XL) 100-300mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.
16185965|NCT01501929|Drug|Nebivolol|The subject will be started on nebivolol (Bystolic) 5-20mg daily, which he or she will continue for a period of 12 weeks. Following the 12-week treatment period, the procedures listed below will be performed. After completion of the study procedures, the medication will be discontinued.
16185966|NCT01501929|Procedure|Non-invasive measurement of Cardiac Output (CO)|Cardiac Output (CO) will be measured non-invasively at rest and during exercise by thoracic electrical bioimpedance. Stroke volume will be derived from change in impedance/time measured during electrical systole. Cardiac output will be determined as the product of stroke volume and heart rate.
16185967|NCT01501929|Procedure|Endothelial cell collection|We will collect endothelial cells from a superficial vein, usually in the arm. Following insertion of a peripheral intravenous (IV) catheter, we will collect cells from the inner lining of the vein using a thin, flexible J-tipped wire. The wire will be inserted through the IV into the vein and then removed, along with a sampling of endothelial cells. The cells collected will be processed and stained for several proteins involved in endothelial cell function, using immunofluorescent technique.
16185968|NCT01501929|Procedure|Microvascular perfusion assessment using Definity|Using high-resolution ultrasound, we will measure skeletal muscle blood flow during infusion of a solution containing the octafluoropropane microbubble contrast agent, Definity. The solution will be a dilution of 1 vial of Definity to 30 cc of normal saline. The ultrasound probe will be placed over the forearm to obtain images while octafluoropropane microbubbles (Definity) are infused intravenously at the rate of 0.20 to 0.27 ml/min, not to exceed a maximum dose of 2 vials per study subject per day or visit. The microvascular perfusion assessment using Definity be performed at rest as well as during slow and fast handgrip exercises.
16185969|NCT01501916|Dietary Supplement|Vitamin D3|daily dosage of 50 µg Vitamin D3 for 8 weeks
16185970|NCT01501916|Dietary Supplement|Placebo|daily intake of placebo
16185971|NCT01501903|Procedure|Standard|FNA in a single plane
16185972|NCT01501903|Procedure|Fanning|FNA in multiple planes
16185973|NCT01501890|Drug|dihydroxyprogesterone caproate|250mg once a week by intramuscular administration
16185974|NCT01501890|Drug|Placebo|0.9% NaCl
16185975|NCT01501877|Behavioral|Acceptance and Commitment Therapy|The intervention is based on Acceptance and Commitment Therapy and will be tailored to smokers with Type 2 diabetes.
16186005|NCT01501604|Drug|BKM120|100 MG PO QD in cycles of 28 days
16185977|NCT01501864|Behavioral|School Support Intervention|Comprehensive school support is provided that includes payment of school fees, school uniform, and a nurse researcher who monitors attendance and addresses problems that may lead to school absence and dropout.
16185978|NCT01501825|Device|5 channels Multiway deep Transcranial Magnetic Stimulator|During the single channel treatment trial period the patients will receive the following dose of rTMS: 10 Hz - left DLPFC ( 10 Hz, at 120% MT, 3 sec pulse train, 20 second inter-train interval, 55 trains, i.e. a total of 1650 pulses per session, a total of 20 sessions in the study and a cumulative exposure (total number of pulses) of 33,000pulses in 4 weeks)
16185979|NCT01501825|Device|five channels Multiway deep Transcranial Magnetic Stimulation|"During the four channels treatment trial period the patients will receive the following dose of rTMS: 10 Hz- left DLPFC, 1Hz - right DLPFC together, and than 10 Hz- left parietal cortex, 1Hz - right parietal cortex together.
~10 Hz protocol: ( 10 Hz, at 120% MT, 3 sec pulse train, 20 second inter-train interval, 55 trains, i.e. a total of 1650 pulses per session, a total of 20 sessions in the study and a cumulative exposure (total number of pulses) of 33,000pulses in 4 weeks)
~1 Hz protocol:
~1 Hz, at 120% MT, 5 min pulse train, 1 min inter-train interval, 6 trains, i.e. a total of 1800 pulses per session, a total of 20 sessions in the study and a cumulative exposure (total number of pulses) of 36,000 pulses in 4 weeks)"
16185980|NCT01501812|Behavioral|Generalization pattern|"During evaluation a conditioning of a tone (conditioning stimulus) and aversive sound (metal scratch) will conduct (another tone which will be un-conditioning stimulus for control). Generalization patterns will be evaluated, by measuring the differentiation capability between different tones (neutral and aversive) before and after the conditioning, and after extinction phase. The generalization will also be measured by the generalization curve that plotted from displaying tones, different from the original tones, and asked the subject whether the current tone is original or new"
16185981|NCT01501799|Drug|adapalene 0.1% and benzoyl peroxide 2.5% topical gel|Dosage form: topical gel Dosage: A pea-sized amount was applied to each affected area of the face Frequency: once daily in the evening Duration: 12 weeks
16185982|NCT01501799|Drug|EPIDUO|EPIDUO (adapalene 0.1% and benzoyl peroxide 2.5%) Gel
16185983|NCT01501799|Drug|Placebo (Vehicle Gel)|Vehicle Gel
16185984|NCT01501786|Drug|control|propofol 8mg/kg/h saline 0.24 ml/kg/h
16185985|NCT01501786|Drug|Ket10|propofol 6.4 mg/kg/h ketamine 10 microg/kg/min
16185986|NCT01501786|Drug|Ket20|propofol 4.8 mg/kg/h ketamine 20 microg/kg/min
16185987|NCT01501773|Biological|Autologous bone marrow stem cell|Autologous bone marrow stem cell have bone marrow aspiration and receive 30-500 million bone marrow mononuclear cells intravenously on the day of randomization.
16185988|NCT01501760|Drug|bevacizumab|Three subconjunctival injections of 0.5 ml of bevacizumab at: inclusion, 1 month, 2 month
16185989|NCT01501760|Drug|NaCl|Three subconjunctival injections 0.5 ml placebo (Balanced salt) solution at inclusion, 1 month, 2month
16185990|NCT01501747|Drug|Caffeine, paracetamol, cephalexin, or ibuprofen|The study has 4 sub-parts (one for each of 4 drugs), each sub-part has a crossover design. In this arm, the volunteer will be given one oral dose of 300 mg caffeine, 500 mg paracetamol, 500 mg cephalexin, or 400 mg ibuprofen and will be told that they are receiving the active drug.
16185991|NCT01501747|Drug|Placebo (caffeine, paracetamol, cephalexin, or ibuprofen)|The study has 4 sub-parts (one for each of 4 drugs), each sub-part has a crossover design. In this arm, the volunteer will be given one oral dose of 300 mg caffeine, 500 mg paracetamol, 500 mg cephalexin, or 400 mg ibuprofen and will be told that they are receiving a placebo.
16185992|NCT01501734|Device|watch-pat|"The Watch-PAT is a home sleep testing (HST) device. The Watch-PAT is a patient-worn, self-contained, non-invasive device used in the patient's home.
~The Watch-PAT diagnoses obstructive sleep apnea (OSA) by measuring the PAT signal, heart rate, oxygen saturation, and actigraphy. The PAT signal is a validated surrogate measure of sympathetic activation that is associated with apneic events and respiratory effort related arousals (RERA). The Watch-PAT provides measures of all the OSA indices, i.e., Apnea Hypopnea Index (AHI), Respiratory Disturbances Index (RDI), and Oxygen Desaturation Index (ODI), which enable accurate assessment of the presence and severity of OSA and its effect on sleep architecture, sleep quality.
~Based on the PAT and actigraphy signals, Watch-PAT differentiates between sleep and wake and detects sleep stages (light, deep, and REM) providing, the effect on additional specific conditions such as REM related apnea."
16185993|NCT01501721|Behavioral|Exercise|Home-based exercise program
16185994|NCT01501721|Behavioral|Diet|Nutritional counseling aiming to reduce suggar intake
16185995|NCT01501708|Drug|Caspofugin based combination therapy|"Caspofungin: 70 mg on the ﬁrst day of therapy, followed by 50 mg q.d.
~All patients received azoles as prophylaxis (fluconazole as prophylaxis and itraconazole or voriconazole as secondary prophylaxis), combination with liposomal amphotericin B at a dosage 3mg/kg q.d will be given.
~In case of renal function damage, combination with voriconazole 6mg/kg followed by 4 mg/kg b.i.d. will be given."
16185996|NCT01501695|Drug|5LGr|Dosage form:Granule Strength:5 gram/sack Dosage:1 sack for patients less than 12 yrs 1.5 sacks for patients 13-18 yrs. Frequency: three times per day. Duration: 8 weeks.
16185997|NCT01501695|Drug|tiapride|"dosage form: tablet Strength:100 mg Dosage: For patients 5-12 yrs: 50mg bid for first 2 weeks, then 100 mg, bid for next 6 weeks; for patients 13-18 yrs:100mg bid for first 2 weeks, then 200 mg bid for next 6 weeks.
~Total duration:8 weeks."
16185998|NCT01501695|Drug|placebo|mimetic granule: same with 5LGr mimetic tablet: same with tiapride
16185999|NCT01501669|Drug|Irinotecan, Capecitabine|"Irinotecan 80 mg/m2, day 1 and 8, every 3 weeks
~+ capecitabine 1000 mg/m2, BID, day 1-14, every 3 weeks"
16186000|NCT01501643|Device|Non invasive positive pressure ventilation|At least one hour every four hour but may be maintained more if the patient chooses to or is asleep with the machine on.
16186001|NCT01501643|Device|Spirometry|Every two hours during the day with 10 maximum inspirations and at night if the patient is awake
16186002|NCT01501630|Device|performance of PET/CT and whole-body MRI|For PET/CT radiopharmaceuticals, both registered in France:Fluoride (18F)FLUOROCHOLINE (18F)No contrast agent scheduled for MRI in the study RadiopharmaceuticalsSingle use, 2-4 MBq/kg body weight, IV infusion
16186003|NCT01501617|Biological|Hair Stimulating Complex (HSC)|Study preparation (experimental) of 0.8 mL will be injected intradermally at Baseline and Week 6.
16186004|NCT01501617|Device|Dulbecco's Modified Eagle Medium, DMEM|Study preparation (placebo comparator) of 0.8 mL will be injected intradermally at Baseline and Week 6.
16186009|NCT01501565|Procedure|Postoperative transverse abdominal plain (TAP) blockade|Bupivacaine 0.25%. Maximum 150 mg. A maximum of 75 mg bupivacaine is administered in each side (posterior and subcostal TAP) in a single puncture.
16186010|NCT01501552|Other|Training and support (T&S)|Two face-to-face educational meetings of at least one hour and a maximum of 2 hours, and one telephone support call of at least ten minutes and a maximum of 30 minutes. The telephone call will be offered to one of the GPs ('leader'). Depending on the needs of the PHCU, one additional face to face training (1 to 2 hours) may be offered. The time interval between meetings will be on average 2 weeks. The training sessions will address improving knowledge, skills, attitudes, and perceived barriers and facilitators by combining theory and practice-based training.
16186011|NCT01501552|Other|Financial incentive|Groups will receive a financial incentive depending on their screening and brief intervention activities. They will be paid for the performance, with the country dependent system of pay (fee for item or fee for achieving set rates) and based on normal practices and financial rates for financial incentives for clinical preventive activities.
16186012|NCT01501552|Other|E-SBI (online screening and brief intervention)|Referring identified at-risk patients to an approved e-SBI programme, which will be either country specific (where these exist) or based on the WHO e-SBI programme (Poland).
16186013|NCT01501539|Procedure|Standard Hydrocolloid Dressing|Treatment placed over insertion site.
16186014|NCT01501539|Procedure|Silver Hydrocolloid Dressing|Place dressing against skin under gastrostomy tube
16186015|NCT01501513|Drug|PEG-3350 based bowel preparation|solution for oral administration prior to colonoscopy
16186016|NCT01501513|Drug|BLI800 approved preparation regimen|solution for oral administration prior to colonoscopy
16186017|NCT01501513|Drug|BLI800 investigational preparation regimen|solution for oral administration prior to colonoscopy
16186018|NCT01501500|Drug|BOTOX|once injection of BTA 3oU into hallux oblique and transverse heads each
16186019|NCT01501500|Drug|Normal Saline (0.9% NaCl)|Normal saline 0.3ml to oblique and transverse heads each
16186020|NCT01501487|Drug|TAC chemotherapy|Docetaxel 75 mg/m2 IV day 1, Doxorubicin 50 mg/m2 IV day 1, Cyclophosphamide 500 mg/m2 IV day 1; Cycled every 21 days for 6 cycles
16186021|NCT01501487|Drug|TC chemotherapy|Docetaxel 75 mg/m2 IV day 1, Cyclophosphamide 600 mg/m2 IV day 1; Cycled every 21 days for 6 cycles
16186022|NCT01501487|Drug|Dose Dense AC or FEC100 followed by paclitaxel or docetaxel chemotherapy|Doxorubicin 60 mg/m2 IV day 1, Cyclophosphamide 600 mg/m2 IV day 1, Cycled every 14 days for 4 cycles, OR 5-Fluorouracil 500 mg/m2 IV day 1, Epirubicin 100 mg/m2 IV day 1, Cyclophosphamide 500 mg/m2 IV day 1; Cycled every 21 days for 3 cycles Followed by Paclitaxel 80 mg/m2 by 1 h IV infusion weekly for 12 weeks, OR Docetaxel 100mg/m2 IV day 1 cycled every 21 days for 3 or 4 cycles
16186023|NCT01501487|Drug|TCH chemotherapy|Docetaxel 75 mg/m2 IV day 1, followed by Carboplatin AUC 6 IV day 1; Cycled every 21 days for 6 cycles Trastuzumab initial dose of 4 mg/kg over 90 minute IV infusion, then 2 mg/kg over 30 minute IV infusion weekly for 52 weeks, OR initial dose of 8 mg/kg over 90 minutes IV infusion, then 6 mg/kg over 30-90 minutes IV infusion every three weeks for 52 weeks.
16186024|NCT01501487|Drug|T + trastuzumab followed by CEF + trastuzumab|"Trastuzumab 4 mg/kg IV for one dose beginning just prior to first dose of paclitaxel.
~Followed by trastuzumab 2 mk/kg IV weekly for 23 weeks Paclitaxel 80 mg/m2 by 1 h IV infusion weekly for 12 wks Followed by 5-Fluorouracil 500 mg/m2 IV on days 1 and 4 Epirubicin 75 mg/m2 IV on day 1 Cyclophosphamide 500 mg/m2 IV on day 1 cycled every 21 days for 4 cycles Trastuzumab 6mg/kg IV every 21 days for 9 cycles to complete 1yr"
16186025|NCT01501487|Drug|Dose dense AC followed by T + trastuzumab|"Doxorubicin 60 mg/m2 IV day 1 Cyclophosphamide 600 mg/m2 IV day 1 (cycled every 14 days for 4 cycles) Followed by paclitaxel 80 mg/m2 by 1 h IV infusion weekly for 12 wks All cycles are with filgrastim support with trastuzumab 2 mg/kg (4 mg/kg loading dose).
~Following chemotherapy , trastuzumab to continue every 3 weeks at 6 mg/kg for the duration of 1 week."
16186026|NCT01501487|Drug|Dose dense AC followed by T + trastuzumab + pertuzumab|Doxorubicin 60 mg/m2 IV day 1 Cyclophosphamide 600 mg/m2 IV day 1 Cycled every 14 days for 4 cycles Followed by docetaxel 75-100 mg/m2 by 1 h IV infusion weekly for 12 wks All cycles are with filgrastim support with trastuzumab 6 mg/kg (8 mg/kg loading dose with C1) Pertuzumab 420 mg (840 mg loading dose with C1). Following chemotherapy, trastuzumab to continue every 3 weeks at 6 mg/kg for the duration of 1 week.
16186027|NCT01501487|Drug|PTH followed by dose dense AC of FEC|"Docetaxel 75-100 mg/m2 by 1 h IV infusion Cycled every 21 days for 4 cycles With Trastuzumab 6 mg/kg IV (8 mg/kg IV loading dose) q3W And Pertuzumab 420 mg IV (840 mg IV loading dose) q 3w +/- pegfilgrastim 6 mg sq on day 2-3,
~Followed by 4 cycles of AC or FEC:
~AC Doxorubicin 60 mg/m2 IV day 1 Cyclophosphamide 600 mg/m2 IV day 1 Cycled every 14 days for 4 cycles with pegfilgrastim 6 mg sq on day 2 FEC 5-Fluorouracil 500 mg/m2 IV on days 1 and 4 Epirubicin 75 mg/m2 IV on day 1 Cyclophosphamide 500 mg/m2 IV on day 1 cycled every 21 days for 4 cycles
~In all of the above mentioned regimens docetaxel might be substituted with paclitaxel as paclitaxel is better tolerated but is expected to have the same efficacy as docetaxel."
16186028|NCT01501461|Procedure|Harvesting and implantation of stem cells|The adipose tissue specimen will be collected from the patient's abdomen or applicable area using tumescent syringe liposuction. The adipose tissue is transferred to the laboratory for separation of the adipose tissue-derived stem cells, which are then transferred for injection intravenously.
16186029|NCT01501448|Drug|Levonorgestrel and ethinylestradiol|30 microgram of ethinylestradiol plus levonorgestrel daily for 12 to 16 days
16186030|NCT01501448|Drug|Estradiol valerate|4mg estradiol valerate from cycle day 20 till the day before the initiation of the cycle
16186031|NCT01501435|Drug|CJ-30039|single dose
16186032|NCT01501435|Drug|fenofibric acid|single dose
16186033|NCT01501422|Drug|Estrogen patch|50 microgram estrogen patch weekly
16186034|NCT01501422|Drug|Placebo|Placebo patch for 8 weeks
16186035|NCT01501409|Other|sodium lauryl sulfate|The subjects were divided into three groups, each of which comprised 30 randomly assigned subjects: group I used SLS-free(a commercially available SLS-free dentifrice(Wiconi® dentifrice) and SLS-A (a dentifrice containing 1.5%; Wiconi® dentifrice + 1.5% SLS). The subjects used one of the two assigned dentifrices for 8 weeks, and then the other for the following 8 weeks. The order of the dentifrices used was selected at random, and there was a 2-week washout period between the two phases, during which the subject used the same dentifrice as they used before participating in this study. The subjects were asked to brush their teeth using their usual toothbrushing method with the dentifrice and toothbrush supplied.
16186036|NCT01501409|Other|sodium lauryl sulfate|The subjects were divided into three groups, each of which comprised 30 randomly assigned subjects: group II used SLS-A (a dentifrice containing 1.5%; Wiconi® dentifrice + 1.5% SLS) and SLS-B (a commercially available 1.5% SLS-containing dentifrice). The subjects used one of the two assigned dentifrices for 8 weeks, and then the other for the following 8 weeks. The order of the dentifrices used was selected at random, and there was a 2-week washout period between the two phases, during which the subject used the same dentifrice as they used before participating in this study. The subjects were asked to brush their teeth using their usual toothbrushing method with the dentifrice and toothbrush supplied.
16186037|NCT01501409|Other|sodium lauryl sulfate|The subjects were divided into three groups, each of which comprised 30 randomly assigned subjects: group III used SLS-free (a commercially available SLS-free dentifrice (Wiconi® dentifrice), and SLS-B (a commercially available 1.5% SLS-containing dentifrice). The subjects used one of the two assigned dentifrices for 8 weeks, and then the other for the following 8 weeks. The order of the dentifrices used was selected at random, and there was a 2-week washout period between the two phases, during which the subject used the same dentifrice as they used before participating in this study. The subjects were asked to brush their teeth using their usual toothbrushing method with the dentifrice and toothbrush supplied.
16186038|NCT01501396|Drug|Megestrol Acetate|
16186039|NCT01501396|Drug|Mirtazapine|
16186040|NCT01501383|Drug|VX-765 Part A|Tablets of VX-765 given at different doses based on treatment group in Part A
16186041|NCT01501383|Drug|Placebo|Matching placebo
16186042|NCT01501383|Drug|VX-765 Part B|Tablets of VX-765 given at different doses based on patients who meet the study eligibility criteria for Part B
16186043|NCT01501370|Drug|Vorinostat|Vorinostat orally at the dose of 400 mg/day on days 1-7 and 15- 21 on a 28-day cycle
16186044|NCT01501370|Drug|Lenalidomide|Lenalidomide orally at the dose of 25 mg/day for 21 days every 28 days
16186045|NCT01501370|Drug|Dexamethasone|Dexamethasone orally at the dose of 40 mg day 1,8, 15, 22 every 28 days.
16186046|NCT01501370|Drug|Lenalidomide|Lenalidomide orally at the dose of 25 mg/day for 21 days every 28 days
16186047|NCT01501370|Drug|Dexamethasone|Dexamethasone orally at the dose of 40 mg day 1,8, 15, 22 every 28 days.
16186048|NCT01501357|Behavioral|modified toothbrush with multilevel filaments|After the allocation of patients in this group they were instructed to brush their first molars erupt with the brushing technique anteroposterior.
16186049|NCT01501357|Behavioral|cross toothbrushing|Children allocated to the group multi-bristled brush will be modified compared to the results of the group cross toothbrushing technique
16186050|NCT01501344|Dietary Supplement|200 g yogurt with fortified calcium content and MBP 80 mg|Intake of one container of vanilla or strawberry yogurt in the morning on a daily basis during 12 weeks.
16186051|NCT01501331|Device|CRTD or ICD (Energen)|RRT measurement by cardiac resynchronization therapy devices and implantable cardioverter defibrillators
16186052|NCT01501318|Behavioral|Personalized feedback report|Participants receive the personalized feedback report but no additional education.
16186053|NCT01501318|Behavioral|Personalized feedback report plus education|Participants receive the personalized feedback report plus education. This is the currently implemented service approach.
16186054|NCT01501305|Dietary Supplement|Mineral solution|Rehydration mineral solution
16186055|NCT01501305|Dietary Supplement|Carob powder with probiotics|7 1/2 grams of carob powder and probiotic twice daily for one week or until diarrhea is gone
16186056|NCT01501292|Other|Fixation and staining|Fixation and staining by MitiTracker Green FM
16186057|NCT01501292|Other|Observation by laser microscopy|Observation with Laser scanning confocal microscopy
16186058|NCT01501279|Procedure|Pudendal nerve block|the pudendal nerve block is going to be performed to the medial of ischial tuberosity with USG guidance in lithotomy position
16186059|NCT01501253|Drug|CKD-828 2.5/40mg|fixed dose combination of S-Amlodipine 2.5mg and Telmisartan 40mg
16186060|NCT01501253|Drug|CKD-828 2.5/80mg|Fixed dose combination of S-Amlodipine 2.5 and Telmisartan 80mg
16186061|NCT01501253|Drug|S-Amlodipine 2.5mg|S-Amlodipine 2.5mg monotherapy
16186062|NCT01501227|Device|Taper Guard Endotracheal Tube|comparison of two different endotracheal tubes
16186063|NCT01501227|Other|Conventional endotracheal tube|Sham Comparator
16186064|NCT01501214|Drug|Atosiban|Patients in the atosiban group will receive intravenous atosiban 30 min before the transfer with a bolus dose of 6.75 mg, and the infusion will be continued with an infusion rate of 18 mg/h. After performing ET, the dose of atosiban will be reduced to 6 mg/h and the infusion will be continued for 2 hours (total administered dose: 37.5 mg). Those in the placebo group will receive normal saline only.
16186065|NCT01501214|Drug|Normal saline|Normal saline given
16186066|NCT01501201|Procedure|Gastric By-Pass|Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGBP)
16186067|NCT01501201|Drug|optimized medical management|group receiving an optimized medical management, among patients with obesity and poorly controlled type 2 diabetes
16186068|NCT01501188|Other|Kinesio Taping|The participants were randomly assigned to an experimental group, to received Kinesio Taping application for gastrocnemius muscle enhancement and functional correction of the ankle.The treatment was performed three times a week during a 4-week period.
16186069|NCT01501188|Other|Placebo kinesio taping|Placebo-control group received treatment with a sham Kinesio Taping protocol to enhance gastrocnemius muscle function and dorsal ankle flexion.The strips used in this group did not follow the principles of tension and anatomic distribution of Kinesio technique.The treatment was performed three times a week during a 4-week period
16186070|NCT01501175|Other|consultation with a vascular physician|As in usual practice, patient with suspected SVT will consult a vascular physician to diagnose SVT and eventually DVP/PE associated. Vascular physician will collect risk factors of SVT.
16186071|NCT01501162|Drug|hepatitis, alcohol, probiotics|7 days of probiotics (1500 mg/day)
16186072|NCT01501162|Drug|alcohol, hepatitis, Placebo|Placebos of the same shape and size were manufactured at Pharmaceutical Corporation.
16186073|NCT01501149|Drug|DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase)|DDP 20 mg/m2,ivgtt（intravenously guttae）,d1-4;DEX 15mg/m2,ivgtt,d1-5;GEM 800mg/m2,ivgtt,30min,d1,8;Pegasparaginase,im,2500IU/m2 d1.Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles.
16186408|NCT01498770|Drug|Ziprasidone|Ziprasidone prescribed as recorded in the CPRD in the UK
16186074|NCT01501149|Drug|Modified SMILE （MTX，DEX，IFO，L-ASP，Etoposide，Mesna）|MTX,2g/m2 (20% ivgtt（intravenously guttae）,2h;80% ivgtt,4h), d1;DEX,40mg,ivgtt,d2-4;IFO,1.5g/m2,ivgtt,d2-4;L-ASP,6000U/m2,ivgtt,d3-9;VP-16,100mg/m2,ivgtt,d2-4; Mesna,0、4、8h after IFO, 240mg/m2,iv,d2-4.Every 21 days for one cycle and three cycles are required. Efficacy was evaluated every two cycles.
16186075|NCT01501136|Other|DDGP(cisplatin,dexamethasone,gemcitabine,pegaspargase)|DDP 20 mg/m2,ivgtt（intravenously guttae）, d1-4;DEX 15mg/m2,ivgtt,d1-5;GEM 800mg/m2,ivgtt,30min,d1,8;Pegasparaginase,im,2500IU/m2 d1.Every 21 days for one cycle and three cycles are required. Completion of chemotherapy is followed by radiotherapy 50Gy.Efficacy was evaluated every two cycles.
16186076|NCT01501136|Other|VIPD（cisplatin，Etoposide，Ifosfamide， dexamethasone，Mesna）|DDP,33mg/m2,ivgtt（intravenously guttae）,d1-3；VP-16,100mg/m2,ivgtt,d1-3；IFO,1.2g/m2,ivgtt,d1-3；DEX,40mg,ivgtt,d1-4；Mesna,0、4、8h after IFO,240mg/m2,iv,d1-3.Every 21 days for one cycle and three cycles are required. Completion of chemotherapy is followed by radiotherapy 50Gy.Efficacy was evaluated every two cycles.
16186077|NCT01501136|Other|gemcitabine,pegaspargase,cisplatin,dexamethasone|Radiotherapy 50Gy is followed by chemotherapy(DDP 20 mg/m2,ivgtt（intravenously guttae）,d1-4;DEX 15mg/m2,ivgtt,d1-5;GEM 800mg/m2,ivgtt,30min,d1,8;Pegasparaginase,im,2500IU/m2 d1.Every 21 days for one cycle and three cycles are required ).Efficacy was evaluated every two cycles.
16186078|NCT01501136|Other|cisplatin,Etoposide,Ifosfamide,dexamethasone,Mesna|Radiotherapy 50Gy is followed by chemotherapy(DDP,33mg/m2,ivgtt（intravenously guttae）,d1-3；VP-16,100mg/m2,ivgtt,d1-3；IFO,1.2g/m2,ivgtt,d1-3；DEX,40mg,ivgtt,d1-4；Mesna,0、4、8h after IFO,240mg/m2,iv,d1-3.Every 21 days for one cycle and three cycles are required ).Efficacy was evaluated every two cycles.
16186079|NCT01501136|Radiation|Radiotherapy|Suitable type intensity-modulated radiation therapy(IMRT)50Gy
16186080|NCT01501123|Drug|Haloperidol|5mg IM
16186081|NCT01501123|Drug|Midazolam|IM midazolam
16186082|NCT01501110|Drug|N-acetylcysteine|in infusion of 1200 mg of n-acetylcysteine twice a day for 48 hours
16186083|NCT01501097|Procedure|Continuous Renal Replacement Therapy|Patients will be randomized to either arm :early HV-crrt(50ml/kg/h) or Control group
16186084|NCT01501084|Drug|Exenatide|10mcg sc (subcutaneous) injection once at one of the 2 MRI visits
16186085|NCT01501084|Drug|Normal saline .2cc subcutaneous injection|sterile saline injection
16186086|NCT01501071|Device|Esophageal calibration tube|An orogastric calibration tube is inserted during laparoscopic Nissen fundoplication in order to secure a certain esophageal lumen for reducing postoperative dysphagia
16186087|NCT01501058|Behavioral|parent-assisted social skills training program for adolescents with autism spectrum disorder|The subjects will participate in the treatment program weekly for a total of 14 weeks. The final visit will be made at the point three months after the completion of treatment to see mid- and long-term effects.
16186088|NCT01501058|Behavioral|Delayed intervention|Intervention is provided to Waitlist Control Group after waiting for 14 weeks
16186089|NCT01501045|Device|TMS system MagPro x100, Tonica Elektronik A/S, Denmark|repeated TMS (rTMS)
16186090|NCT01501045|Device|TMS system MagPro x100, Tonica Elektronik A/S, Denmark|repeated TMS
16186091|NCT01501032|Device|MD-logic artificial pancreas system|The MD-logic artificial pancreas system is a closed loop control system using continuous glucose monitoring (CGM)and subcutaneous insulin pump infusion to mange glucose control in individuals with type 1 diabetes
16186092|NCT01501019|Other|Exercise training|"Sjöegren arm: 30-60 minutes of combined aerobic and strength exercises, twice a week, moderate intensity.
~Myositis arm: 30 minutes of resistance training combined partial blood flow restriction, twice a week, low intensity.
~Takayasu's arteritis arm: 30-50 minutes of aerobic, twice a week, moderate intensity."
16186093|NCT01500993|Drug|Capecitabine|Capecitabine standard therapy (i.e. 2,500 mg/sqm) x 5 cycles plus 1 cycle of capecitabine based chemoradiotherapy (1.650 mg/sqm)
16186094|NCT01500993|Drug|5-FU|4 cycles of bolus 5-FU (500 mg/sqm) and 1 cycle of 5-FU based chemoradiotherapy (either 1,000 mg/sqm/day infusional 5-Fu days 1-5 and 29-33 or 225 mg/sqm/day infusional 5-Fu throughout the time of chemoradiotherapy)
16186095|NCT01500980|Biological|P. falciparum infection|P. falciparum (NF54 strain) infection delivered by the bites of 12 - 15 infected A. stephensi mosquitos
16186096|NCT01500980|Drug|Chloroquine|Weekly chloroquine dosing (600 mg loading dose, 300 mg thereafter)
16186097|NCT01500980|Drug|Primaquine|Primaquine (45 mg) on day 2 or 3 post ITV infection
16186098|NCT01500980|Drug|Primaquine|Primaquine (45 mg) on day 2 or 3 (pending results of pilot study) post ITV infection
16186099|NCT01500967|Other|Shi-style cervical manipulations|Shi-style cervical manipulation is a spinal manipulation for cervical radiculopathy.It is a kind of traditional chinese massage and can dredge the meridian.Patients are treated every day for 30 minutes.Seven times at one course and totally there are two courses.3 times a week, once the other day（except the weekends）,30 minutes, 2 weeks.
16186100|NCT01500967|Other|Cervical Traction control|6kg to 10kg, 3 times a week, once the other day（except the weekends）,20 minutes, 2 weeks.
16186101|NCT01500941|Dietary Supplement|probiotics|a mixture of Lactobacillus LS01 DSM 2275 and Bifidobacterium BR03 DSM 16604 at a dose of 1 x 109 colony forming units (CFU)/g each in maltodextrin
16186102|NCT01500941|Other|maltodextrin|sachets
16186103|NCT01500928|Device|SOLO insulin pump|Use of the SOLO insulin pump for treatment of type 1 diabetes.
16186104|NCT01500915|Drug|Ranibizumab|0,5mg intravitreal ranibizumab
16186105|NCT01500902|Other|EndoPAT testing (non invasive device)|Using the EndoPAT device, we will assess endothelial function.
16186106|NCT01500902|Other|WatchPAT testing (non-invasive device)|Using the WATCHPAT device we will assess sleep apnea.
16186107|NCT01500889|Procedure|Group I: Conventional Lateral internal sphincterotomy:|LIS was performed in the lithotomy position by a standard open technique, briefly; a 5-mm incision was made into the perianal skin along the intersphinteric groove. The internal anal sphincter was then dissected and a segment withdrawn with a pair of artery forces and divided with diathermy to the level of the dentate line. Figures 5, 6, 7 and 8 illustrate the procedure.
16186147|NCT01500629|Device|C-1266-7|Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Investigational Nasal Spray (C-1266-7) in each nostril, for a total of 200 uL per treatment.
16186148|NCT01500629|Device|C-1266-6 (placebo)|Each subject will receive two sprays (50 uL per spray for a total of 100 uL) of Sham Nasal Spray (C-1266-6, placebo) in each nostril, for a total of 200 uL per treatment.
16186108|NCT01500889|Procedure|GroupII: V-Y advancement flap|"GroupII: V-Y advancement flap:
~The V-Y advancement flap was performed by making a V-shaped incision from the edges of the fissure extending about 4 cm from the anal verge and away from the midline. The V-shaped flap formed of skin and subcutaneous fat was mobilized sufficiently to allow advancement into the anal canal to cover the fissure defect. Care was taken to preserve enough pedicles to ensure adequate blood supply. The base of flap was sutured to the lower anal mucosa with interrupted 000 Vicryl Rapide."
16186109|NCT01500889|Procedure|GroupIII: Tailored LIS with V-Y advancement flap|Tailored lateral sphincterotomy was performed in the lithotomy position by a standard open technique, briefly; a 5-mm incision was made into the perianal skin along the intersphinteric groove. The internal anal sphincter was then dissected and a segment withdrawn with a pair of artery forces and divided with diathermy, the extent of sphincterotomy was done to be more or less equal to the length of the fissure. Then the V-Y advancement flap was performed.
16186110|NCT01500876|Radiation|4D-CT pre-treatment scan|Undergo pre-treatment 4D-CT study for treatment planning External Beam Radiation: standard fractionation (2Gy per day) or stereotactic body radiation therapy Evaluation: Repeat 4D-CT study at 3 months and 6 months post-treatment
16186111|NCT01500863|Drug|hCG|single shot of 6500 IU hCG s.c. at the time of triggering
16186112|NCT01500863|Drug|triptorelin|single shot of 0.2mg triptorelin s.c. at the time of triggering
16186113|NCT01500863|Drug|Triptorelin, estradiol valerate, micronized vaginal progesterone|4mg of estradiol valerate per os plus 400mg micronized vaginal progesterone daily starting the day after OPU
16186114|NCT01500863|Drug|triptorelin, hCG|single shot of 1500 IU hCG s.c. the day of OPU plus 4mg of estradiol valerate per os plus 400mg micronized vaginal progesterone daily starting the day after OPU
16186115|NCT01500863|Drug|triptorelin, hCG|Multiple doses of 500 IU hCG (OPU, +4 and +7) and 4mg of estradiol valerate per os plus 400mg micronized vaginal progesterone daily starting the day after OPU
16186116|NCT01500863|Drug|triptorelin, recombinant LH|300 IU recombinant LH every 48h and 4mg of estradiol valerate per os plus 400mg micronized vaginal progesterone daily starting the day after OPU
16186117|NCT01500850|Drug|nph insulin|Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL.
16186118|NCT01500850|Drug|human insulin|"Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL.
~human insulin: bolus injections before each main meal"
16186119|NCT01500850|Drug|Insulin Glargine|Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL.
16186120|NCT01500850|Drug|Insulin glulisine|"Dosage will be pro re nata. Patients should aim an blood glucose level of ≤ 100 mg/dL.
~Insulin glulisine: bolus injections before each main meal"
16186121|NCT01500837|Drug|association of RIFAMPIN + CLINDAMYCIN|association of RIFAMPIN + CLINDAMYCIN
16186122|NCT01500837|Drug|association of LEVOFLOXACIN+ CLINDAMYCIN|association of LEVOFLOXACIN+ CLINDAMYCIN
16186123|NCT01500824|Drug|Crizotinib|Crizotinib, 250 mg BID, will be administered orally at approximately the same time each day on a continuous daily dosing schedule
16186124|NCT01500811|Biological|cell injection|Intra articular injection of chondrocyte
16186125|NCT01500798|Drug|20 mg bardoxolone methyl|20 mg, oral, once daily
16186126|NCT01500798|Drug|Placebo|Oral, once daily
16186127|NCT01500785|Drug|levosimendan|infusion; levosimendan (12 μg/kg) The study drug will be administered together with the induction of cardioplegia solution during five minutes (=once for each patient)
16186128|NCT01500785|Drug|Vitamin B 12|Infusion made of Glucos B.Braun 50 mg/ml infusion together with vitamin B12 which is used to colour the glucose infusion to look identical to Simdax infusion The placebo will be administered together with the induction of cardioplegia solution during five minutes (=once for each patient).
16186129|NCT01500772|Drug|Alisporivir|ALV 200 mg soft gel capsules administered orally
16186130|NCT01500772|Drug|Peginterferon alfa-2a|PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
16186131|NCT01500772|Drug|Ribavirin|RBV 200 mg tablets (weight-based dose: < 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose
16186132|NCT01500746|Procedure|Pulse lavage treatment|A pulse lavage machine will be used to irrigate the wound with a total of 4 liters of water, twice daily, for a total of 4 days (8 treatments).
16186133|NCT01500746|Other|Dressing changes|Wounds will be treated with moist gauze dressing changes twice daily for a total of 4 days (8 treatments).
16186134|NCT01500733|Drug|PCI 32765|420 mg daily
16186135|NCT01500720|Drug|Cabazitaxel|Cabazitaxel 25 milligram per square meter (mg/m^2) intravenously (IV) on Day 1 every 3 weeks (21-day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
16186136|NCT01500720|Drug|Topotecan|Topotecan 1.5 mg/m^2 IV on Day 1 to Day 5 every 3 weeks (21-Day cycle) until unacceptable toxicity, disease progression or withdrawal consent.
16186137|NCT01500707|Drug|SCH 900800|SCH 900800, one 20 mg tablet, orally
16186138|NCT01500694|Drug|Extended-release Guanfacine HCl (Intuniv, SPD503)|Subjects will be dosed orally once-daily in the AM at 1, 2, 3, 4, 5, 6, or 7 mg according to subjects weight and age
16186139|NCT01500681|Procedure|Plasma exchange (PLEX)|Regular maintenance PLEX courses, typically 3 procedures monthly
16186140|NCT01500668|Drug|Botox|Injection of 200 units of Botulinum Toxin A (BOTOX) to a treated limb. Each limb will be divided to two levels - arterial arch and digital arteries (near MCP/MTP) levels. In each level 100 units of Botox will be injected in 6 injection points in the proximity of the arteries.
16186141|NCT01500668|Drug|Placebo|Injection of 0.5cc of normal saline (0.9% NaCl) to each injection site as in the Active drug arm.
16186142|NCT01500655|Procedure|Regional nerve block|a block of the lateral femoral cutaneous nerve is performed under ultrasound guidance. For LFCN block, ropivacaine 0.2% will be used. Dose will be 20 ml, unless patient weighs less than 20 kg, in which case volume will be equal to patient's weight in kilograms.
16186143|NCT01500655|Procedure|Catheter|After an ultrasound guided nerve block is performed a catheter is placed under the fascia iliaca and an infusion of ropivacaine 0.2% running at 0.15 ml/kg/hour is administered for 48 hours.
16186144|NCT01500642|Biological|Slit One|slit one sublingual immunotherapy 200 stu
16186145|NCT01500642|Biological|Slit One|slit one vestibular immunotherapy 200 stu
16186146|NCT01500642|Biological|Slit One ragweed|slit one 400 stu dose ragweed (sublingual doubled immunotherapy)
16186149|NCT01500616|Drug|Telaprevir|type = exact number, unit = mg, number = 750, form = tablet, route = oral use, every 8 hours for 12 weeks in combination with pegylated interferon alfa (Peg-IFN alfa) and ribavirin (RBV) during 48 weeks for eligible non treated HIV patients and for patients whose highly active antiretroviral therapy (HAART) regimen is the combination of ritonavir-boosted atazanavir, plus either TDF or abacavir, plus either emtricitabine or lamivudine, or the combination of raltegravir, plus either TDF or abacavir, plus either emtricitabine or lamivudine, or etravirine, TDF, plus either emtricitabine or lamivudine, or etravirine, abacavir, plus either emtricitabine or lamivudine, or rilpivirine, TDF, plus either emtricitabine or lamivudine, or rilpivirine, abacavir, plus either emtricitabine or lamivudine.
16186150|NCT01500616|Drug|Telaprevir|type = exact number, unit = mg, number = 1125, form = tablet, route = oral use, every 8 hours for 12 weeks in combination with Peg-IFN alfa and RBV during 48 weeks when patient's HAART regimen is the combination of efavirenz, plus either TDF or abacavir, plus either emtricitabine or lamivudine, or etravirine, TDF, plus either emtricitabine or lamivudine, or etravirine, abacavir, plus either emtricitabine or lamivudine, or rilpivirine, TDF, plus either emtricitabine or lamivudine, or rilpivirine, abacavir, plus either emtricitabine or lamivudine.
16186151|NCT01500603|Device|AdvanceXP Male sling device|Patients will receive AdvanceXP retrourethral male sling (polypropylene mesh) implantation under general or loco-regional anaesthesia, by perineal approach. The sling is placed via transobturator route.
16186152|NCT01500603|Device|Pro-ACT balloon device|Patients will receive Pro-ACT balloons implantation under general or loco-regional anaesthesia, by perineal approach. The balloons are placed under X-ray control laterally to the urethra, under the bladder neck. The extremity of the device (titanium port), linked to the balloon, is located subcutaneously in the scrotum. During post-operative visits, readjustments of the volume of the balloons will be made under local anaesthesia. The volume will be increased or decreased according to the patients symptoms.
16186153|NCT01500590|Drug|Renin-angiotensin system blockers|ramipril 2.5mg to 10mg once daily if patient experience cough, we will use irbesartan 150 mg to 300mg once daily
16186154|NCT01500590|Drug|non-renin angiotensin system blockers|amlodipine 2.5 to 10 mg once daily nifedipine retard 20mg to 40mg twice daily indapamide 2.5mg once daily metoprolol 25mg to 100mg daily methyldopa 125 mg to 500mg twice daily
16186155|NCT01500577|Drug|nimesulide|Nimesulide 100 mg (capsules). 100mg/die every day for 1 year. Oral administration
16186156|NCT01500577|Drug|Simvastatin|Simvastatin 20 mg (capsules). 20mg/die every day for 1 year. Oral administration
16186157|NCT01500577|Other|Placebo|Placebo (capsules). 1 cps/die every day for 1 year. Oral administration
16186158|NCT01500564|Device|anodal tDCS (device) Eldith DC-Stimulator|tDCS applied to the motor cortex every day of two consecutive weeks (10 sessions) at 1 mA during 20 minutes. Conductive rubber covered by sponges soaked in saline will be used, held in place by a band. The current will be gradually increased over 100 seconds.
16186159|NCT01500564|Device|Sham tDCS|Participants will receive sham tDCS over the primary motor cortex of the ipsilesional hemisphere during 20 minutes of motor training (10 consecutive sessions Monday-Friday during two weeks).
16186160|NCT01500551|Drug|Tofacitinib|"Tofacitinib will be administered orally BID (twice daily) approximately 12 hours (±2 hours) apart, once in the morning and once in the evening, based on body weight for all subjects for all three index studies (A3921103, A3921104, and A3921165)
~5 mg BID Dose Level:
~Body Weight (Dose in tablet [mg BID] or solution [ml BID]) 5 - < 7 kg (2 mg or 2 ml) 7 - < 10 kg (2.5 mg or 2.5 ml) 10 - <15 kg (3 mg or 3 ml) 15 - <25 kg (3.5 mg or 3.5 ml) 25 - <40 kg (4 mg or 4 ml) >=40 kg (5 mg or 5 ml)
~Oral solution (1 mg/mL concentration) will be used for subjects weighing <40 kg. Oral tablets (5 mg) will be used for subjects weighing >=40 kg; subjects who are unable to swallow tablets will have the option of taking oral solution.
~Subjects will swallow study tablets whole and will not manipulate or chew tablets prior to swallowing."
16186161|NCT01500551|Drug|Tofacitinib|For subjects rolling over from study A3921103 and actively participating in this study at the time of Protocol Amendment 6 and receiving a dosage of tofacitinib in accordance with the dosing scheme specified in Protocol Amendment 5, investigators will have the option of maintaining the subject's current dosage regimen from index study A3921103 (if the desired clinical response has been attained with no safety concern) or adjusting the dosage regimen in accordance with the dosing scheme specified in this section.
16186162|NCT01500538|Drug|Eltrombopag and Vorinostat|4 week mono-therapy eltrombopag, commencing at 50mg/day, increasing to 200mg. Daily intake of 400mg vorinostat for minimum of 6 cycles, each cycle of 4 weeks, possibly in combination with daily intake eltrombopag commencing at 50mg/day at a maximum dose of 200md/day (150mg/day for subjects of East-Asian ancestry)
16186163|NCT01500512|Other|Clinical Observation|Undergo observation
16186164|NCT01500499|Genetic|gene expression analysis|
16186165|NCT01500499|Genetic|gene rearrangement analysis|
16186166|NCT01500499|Genetic|polymerase chain reaction|
16186167|NCT01500499|Genetic|protein analysis|
16186168|NCT01500499|Genetic|western blotting|
16186169|NCT01500499|Other|laboratory biomarker analysis|
16186170|NCT01500499|Other|mass spectrometry|
16186171|NCT01500486|Device|NordiFlex PenMate™|Subjects whom will be offered growth hormone (Norditropin NordiFlex®) on prescription as part of normal clinical practice will be asked to evaluate the NordiFlex PenMate™ device.
16186172|NCT01500473|Drug|Desogestrel|Reclipsen oral contraceptive pill with 0.03mg ethinyl estradiol and 0.15mg desogestrel
16186173|NCT01500434|Device|PROMUS Element Coronary Stent System|PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
16186174|NCT01500434|Drug|Aspirin|Patients are required to take aspirin indefinitely after stent implant. It is recommended that aspirin 162-325 mg daily be given for at least 6 months after stent placement and that aspirin 75-162 mg daily be given indefinitely thereafter.
16186175|NCT01500434|Drug|Thienopyridine|Patients must be treated with one of the following thienopyridines for at least 6 months following the index procedure: clopidogrel 75 mg daily; or ticlopidine 250 mg twice daily; or prasugrel (outside the United States and if approved at the time of the procedure). If used, the prescribed dose should be in accordance with approved country-specific labeling. In patients not at high risk of bleeding, thienopyridine treatment should continue for at least 12 months after stent implant.
16186409|NCT01498770|Drug|Iloperidone|Iloperidone prescribed as recorded in the CPRD in the UK
16186177|NCT01500421|Device|TH - Endovascular + nasopharyngeal induction (Alsius®, Zoll, USA) (Rhinochill®, Benechill, USA)|Patient are cooled with a groin endovascular catheter (Alsius®, Zoll, USA) + a nasopharyngeal induction catheter (Rhinochill®, Benechill, USA) in the nostrils. The nasopharyngeal induction is designed to give a more quick and localised brain cooling.
16186178|NCT01500421|Device|Intravenous cold saline and surface cooling (Arctic Sun, Medivance, USA)|Infusion of ice cold saline of 4°C (25 mL/kg body weight)followed by surface cooling
16186179|NCT01500408|Drug|Interferon beta-1a (current approved manufacturing process invloving FBS)|Single dose of 60 mcg given Intramuscularly (IM)
16186180|NCT01500408|Drug|Interferon beta-1a (new process, manufactured without FBS)|Single dose of 60 mcg given Intramuscularly (IM)
16186181|NCT01500395|Procedure|Hybrid operation|Hybrid Operations including debranching technique+Thoracic Endovascular Aortic Repair (TEVAR), Frozen elephant trunk technique, aortic arch replacement with concommitant TEVAR, et al. Devices include Medtronic Stent Graft（Medtronic Medtronic, Inc., US） Microport Stent Graft（Microport Co.,LTD.，Shanghai, China） Ankura Stent Graft（Lifetech Scientific Co.,LTD.，Shenzhen, China）.
16186182|NCT01500382|Drug|Vibegron|Tablet, 50 or 100 mg, once daily, for up to 10 days based on treatment assignments and treatment period.
16186183|NCT01500382|Drug|Tolterodine ER|Capsule, 4 mg, once daily, for up to 10 days based on treatment assignment and treatment period.
16186184|NCT01500382|Other|Placebo (vibegron)|Inactive agent in tablet form, oral administration, once daily, up to 5 weeks, based on treatment assignment in each treatment period.
16186185|NCT01500382|Other|Placebo (tolterodine ER)|Inactive agent in capsule form, oral administration, once daily, up to 5 weeks, based on treatment assignment in each treatment period.
16186186|NCT01500382|Drug|Prophylactic Antibiotic|A pre-procedural prophylactic antibiotic (ie, levofloxacin 250 mg, cephalexin) administered orally, 30 minutes prior to each scheduled urodynamic study intervention. It is up to the discretion of the Investigator, based on study protocol recommendations, as to which type of antibiotic may be administered.
16186187|NCT01500369|Other|sphygmomanometer cuff inflations|": Patients in the treatment group will receive three sequential sphygmomanometer cuff inflations on their right upper arm after induction of anesthesia in the operating room. The cuff will be inflated by the OR nurse up to 200 mmHg for five minutes each occasion, with five minutes deflation in between inflations. Following this pre-conditioning phase, routine anesthesia procedures will be implemented. The entire pre-conditioning phase will last 30 minutes."
16186188|NCT01500369|Other|standard of care|Placebo Comparator
16186189|NCT01500356|Behavioral|Behavioral weight loss intervention|Weight loss intervention that focuses on reducing energy intake.
16186190|NCT01500356|Behavioral|Diet Plus Moderate Exercise|Weight loss intervention that involve an energy restricted diet (identical to the Diet Alone arm) plus the inclusion of 150 minutes per week of moderate-intensity exercise.
16186191|NCT01500356|Behavioral|Diet Plus High Exercise|Weight loss intervention that involve an energy restricted diet (identical to the Diet Alone arm) plus the inclusion of 250-300 minutes per week of moderate-intensity exercise.
16186192|NCT01500343|Drug|Saccharomyces boulardii|1 gram per day, during 3 months
16186193|NCT01500330|Procedure|cupping massage|the upper back is covered in massage oil the cupping glass is drawn along the back muscles
16186194|NCT01500330|Procedure|Progressive muscle relaxation|standardized programme on muscle relaxation according to Jacobson
16186195|NCT01500317|Drug|Tapentadol|Subjects received tapentadol immediate release formulation, 75 mg three times per day (tid) for 48 hours.
16186196|NCT01500317|Drug|Oxycodone|Subjects received oxycodone immediate release formulation, 5 mg three times per day (tid) for 48 hours.
16186197|NCT01500317|Drug|Placebo|Subjects received placebo three times per day (tid) for 48 hours.
16186198|NCT01500304|Procedure|Minimally invasive inguinal lymph node dissection|Operative intervention will be a minimally invasive inguinal lymphadenectomy, which is a three trocar technique to the inguinal dissection, that respects the same anatomic boundaries as the conventional open procedure
16186199|NCT01500291|Other|2 courseware databases.|All participant voluntarily response all items in the SST and SAST courseware database.
16186200|NCT01500278|Biological|Certolizumab Pegol (CZP)|"Active substance: an injectable volume of 1 ml solution for injection CZP
~Pharmaceutical form: prefilled syringes CZP
~Concentration: 200 mg/ml CZP
~Route of Administration: injections will be given subcutaneously: loading dose of CZP 400 mg at Baseline, and Weeks 2 and 4, followed by a maintenance dose of 200 mg every 2 weeks through Week 102 or withdrawal."
16186201|NCT01500278|Biological|Adalimumab (ADA)|"Active substance: an injectable volume of 0.8 ml solution for injection ADA
~Pharmaceutical form: prefilled syringes ADA
~Concentration: 40 mg/0.8 ml ADA
~Route of Administration: injections will be given subcutaneously. ADA 40 mg plus an injection with Placebo (to preserve blind) at Baseline, and Weeks 2 and 4, followed by ADA 40 mg every 2 weeks through Week 102 or withdrawal."
16186202|NCT01500278|Drug|Methotrexate (MTX)|"Active substance: Methotrexate
~Pharmaceutical form: oral tablet
~Concentration: 15-25 mg/week
~Route of Administration: MTX orally"
16186203|NCT01500265|Biological|plasma and urine samples, sample with ADN|plasma and urine samples every three months Sample with ADN at baseline
16186204|NCT01500252|Device|Patellar Replacement Prosthesis|The Profix™ Total Knee System, a posterior cruciate retaining prosthesis manufactured by Smith and Nephew, Inc. was utilized in all subjects. Subjects randomized to the Resurfaced group received an all polyethylene patellar implant
16186205|NCT01500252|Device|Profix TKR with Patellar Retention|All subjects received a Profix TKR. Subjects in the Patellar Retention group retained their native patellar surface.
16186206|NCT01500226|Drug|Rolapitant|(4 X 50 mg capsule) 200 mg PO
16186207|NCT01500226|Drug|Granisetron|2 mg PO
16186208|NCT01500226|Drug|Dexamethasone|20 mg PO
16186209|NCT01500226|Drug|Placebo|(4 X 0 mg capsules) 0 mg PO
16186210|NCT01500213|Drug|Rolapitant|200 mg PO
16186211|NCT01500213|Drug|Granisetron|10 mcg/kg IV
16186212|NCT01500213|Drug|Dexamethasone|20 mg PO and 8 mg PO
16186213|NCT01500213|Drug|Placebo|(4 X 0 mg capsules) o mg PO
16186214|NCT01500200|Drug|ALKS 5461|Two active tablets, given daily
16186215|NCT01500200|Drug|Placebo|Two placebo tablets, given daily
16186216|NCT01500187|Device|Vanish Varnish|5% sodium fluoride varnish with tricalcium phosphate
16186219|NCT01500174|Device|Placebo ultraviolet therapy UV254|Three times per week irradiation of wound base and periwound skin
16186220|NCT01500161|Drug|Busulfan|Busulfan 3.2 mg/kg/day intravenously on days -7, -6, -5 and -4(for non-NHL patients patients who get Clofarabine regimen)
16186221|NCT01500161|Drug|Clofarabine|Clofarabine intravenously 40 mg/m2/day on days -7, -6, -5, -4 and -3(for non-NHL patients patients who get Busulfan regimen)
16186222|NCT01500161|Drug|Fludarabine|Fludarabine 30 mg/kg/day intravenously on days -7, -6, -5, -4 and -3 (for non-NHL patients who receive Melphalan containing regimen)
16186223|NCT01500161|Drug|Melphalan|Melphalan intravenously 140 mg/m2/day on day -3 (only for non-NHL patients who receive Fludarabine OR for all NHL regimens)
16186224|NCT01500161|Drug|Carmustine|BCNU(Carmustine)300 mg/m2 intravenously on day -7 (for NHL patients only)
16186225|NCT01500161|Drug|Etoposide|Etoposide 300 mg/m2/day intravenously on days -6, -5, -4 and -3 (for NHL patients only)
16186226|NCT01500161|Drug|Cytarabine|ARA-C(Cytarabine) 100 mg/m2/day on days -6, -5, -4 and -3 (for NHL patients only)
16186227|NCT01500148|Device|PMVr procedure (SJM Percutaneous Mitral Valve Repair (PMVr)|A maximum of ten (10) subjects will receive a percutaneous mitral valve clip procedure.
16186228|NCT01500135|Drug|TachoSil®|TachoSil® is a sterile, ready-to-use, absorbable patch for intra-operative topical application. It consists of an equine collagen patch coated with fibrin glue components: human fibrinogen and human thrombin.
16186229|NCT01500135|Drug|Surgicel® Original|Surgicel® Original is an absorbable hemostat (oxidized regenerated cellulose)
16186230|NCT01500122|Drug|RhuDex|"Part 1:
~Regimen A: Rhudex Formulation in Labrafac/ Gelucire Regimen B: Rhudex Formulation in Labrafac/ Aerosil single dose
~The formulation platform (A or B) that shows the best potential to achieve the target PK profile and shows acceptable safety and tolerability will be progressed into part 2 of the study. The purpose of part 2 is to optimize the selected formulation platform. This will be achieved by administrating up to four different formulation compositions."
16186231|NCT01500109|Drug|Oral acetaminophen|Oral acetaminophen administered as a cherry flavored elixir will be dosed preoperatively 15 mg/kg and redosed every 6 hours for 24 hours. Placebo oral acetaminophen will be administered to the other two arms of the study according to the same timetable. Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed.
16186232|NCT01500109|Drug|Ofirmev®|Intravenous acetaminophen is initiated after intravenous access is obtained intraoperatively and before surgical incision. Dosing is age based as follows: 5 months-2 years 12.5 mg/kg, 2-5 years 15 mg/kg. Redosing will be every 6 hours for 24 hours. The two other arms will receive a placebo in the form of normal saline given intravenously. Intraoperative opioids will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed.
16186233|NCT01500109|Drug|Opioid only|Intraoperative opioids (Fentanyl or Morphine) will be administered as deemed necessary by anesthesia care team. in the PACU, fentanyl 0.5-1 mcg/kg will be administered for moderate-severe pain. Once discharged from PACU, morphine 0.05 mg/kg will be given every 3 hours as needed.
16186234|NCT01500096|Drug|American ginseng|American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the intervention arms for this study. Participants will be randomized to American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.
16186235|NCT01500096|Dietary Supplement|Placebo for American ginseng|"Placebo for American ginseng 1000 mg/day and 3000 mg/day will be evaluated in the control arms for this study. Participants will be randomized to placebo for American ginseng 1000 or 3000 mg/day capsules taken daily for four weeks.
~Arms: Placebo for American ginseng 1000 mg/day, Placebo for American ginseng 3000 mg/day"
16186236|NCT01500083|Drug|Bendamustine at a dose of 100 mg/m2|Bendamustine will be administered intravenously over 30 minutes.
16186237|NCT01500083|Drug|Bendamustine at a dose of 120 mg/m2|Bendamustine will be administered intravenous (i.v.) over 60 minutes.
16186238|NCT01500070|Device|Everolimus-Eluting Stent (PROMUS ELEMENT)|PROMUS ELEMENT Everolimus-Eluting Stent System (Boston Scientific) or PROMUS ELEMENT PLUS Everolimus-Eluting Stent System (Boston Scientific).
16186239|NCT01500057|Device|Greenlight XPS Laser|Treatment of BPH with Greenlight XPS laser
16186240|NCT01500057|Device|BiVAP Saline Vaporization of the prostate|treatment of BPH with BiVAP Saline Vaporization
16186241|NCT01500044|Procedure|Program targeting the opening of foramen|Rehabilitation intervention that specifically targets the opening of the intervertebral foramen
16186242|NCT01500044|Procedure|Conventional Rehabilitation Program|Program used in previous randomized clinical trials in this population
16186243|NCT01500031|Device|OffRoad Re-entry Catheter System|Facilitate the placement and positioning of guidewires within the peripheral vasculature.
16186244|NCT01500018|Drug|TC-5214|Single oral dose of 2 mg
16186245|NCT01500018|Drug|TC-5214 Placebo|Single oral dose
16186246|NCT01500018|Drug|Ketamine|Single oral dose of 100 mg
16186247|NCT01500018|Drug|Phentermine|Single oral dose of 45 mg
16186248|NCT01500018|Drug|TC-5214|Single oral dose of 8 mg
16186249|NCT01500018|Drug|TC-5214|Single oral dose of 16 mg
16186250|NCT01500018|Drug|Phentermine|Single oral dose of 90 mg
16186251|NCT01500005|Drug|Baby D3 drops|2000-4000 iu per day
16186252|NCT01499992|Procedure|Standard physical therapy program PLUS aquatic physical therapy|2. Standard physical therapy program PLUS aquatic physical therapy: The above PLUS a aquatic physical therapy program which will be conducted twice weekly for 10 weeks and will include a 40-50 minute hydrotherapy session emphasizing range of motion and light resistive exercises of the arm, primarily focusing on the shoulder. The program will start with general mobility of the other upper limb joints to allow time for preconditioning of the painful shoulder. Shoulder exercises will emphasize flexion, rotation and abduction and a slow transition from pain-free range to the restricted range of motion to maximize the effectiveness of the heat and buoyancy.
16186253|NCT01499992|Other|standard care|Total of 12 weeks; each exercise session will be 20 -30 minutes of direct contact and additional supervised exercise as defined by assignment and stage.
16186254|NCT01499979|Procedure|In situ hypothermic perfusion|In situ perfusion of the future remnant liver with chilled lactated Ringer's solution during liver resection.
16186255|NCT01499966|Procedure|Plaster of Paris/ Tubigrip|"After informed consent was obtained the patients were randomized such that each patient was allocated to use either a Tubigrip (Group A) or Plaster of Paris (Group B). The standardized treatment in the form of RICE (Rest, Ice, Compression and Elevation) protocol was given to all patients. The Patients were randomized using the Block randomization. One hundred and twenty six white papers were taken and TG for Tubigrip and POP for Plaster of Paris were written and the patients were allowed to pick the envelope of their choice. The authors were blinded till the opening of the envelope by the patients. Patient's usage of analgesia in form of Paracetamol was specifically noted. The patients in TG group receive the Tubigrip treatment and the patients in POP group were given a below knee plaster cast. Patients were instructed to follow up at 2 weeks and then at 6 weeks"
16186256|NCT01499953|Drug|Rivaroxaban|Dose: 10 mg Duration: 45 (±5) days Frequency: once daily Application: oral
16186257|NCT01499953|Drug|Fondaparinux|Fondaparinux Dose: 2.5 mg Duration: 45 (±5) days Frequency: once daily Application: subcutaneous
16186258|NCT01499940|Drug|Vitamin D3|Vitamin D3 will be administered at a dose of 2000 IU orally daily starting on day 1 of the first cycle of oxaliplatin. The vitamin will be continued at this dose and schedule for approximately 6 months if the patient is receiving oxaliplatin in the adjuvant setting and neither dosage nor interval has been modified for neurological toxicity. The duration of therapy if oxaliplatin is given for metastatic disease will vary. Nonetheless, the study vitamin will be continued using the same criteria as in the adjuvant setting.
16186259|NCT01499927|Other|electronic reminders|Behavioral: Early switching from intravenous to oral antiinfective agents due to electronic reminders
16186260|NCT01499914|Biological|influenza vaccination|Influenza vaccination in patients with cystic fibrosis
16186261|NCT01499901|Procedure|bilateral cochlear Implantation in sequential|bilateral cochlear Implantation in sequential
16186262|NCT01499901|Procedure|bilateral cochlear Implantation in simultaneous|bilateral cochlear Implantation in simultaneous
16186263|NCT01499888|Procedure|Allogeneic Non-Myeloablative Stem Cell Transplantation|"Alemtuzumab-based non-myeloablative allogeneic hematopoietic stem cell transplantation using immune-suppressive agents and low-dose total body irradiation (TBI) without standard chemotherapy.
~Transplant regimen Day -7 to -3: Alemtuzumab (1mg/kg, total dose) divided over the 5 days, IVPB over 2 hours daily Day -3 until 100% chimerism obtained: Sirolimus dosed for target trough level of 10-15 ng/mL Day -2: Total body irradiation with 300cGy Day 0: Stem cell infusion"
16186264|NCT01499888|Drug|Alemtuzumab|In this protocol, patients will be given alemtuzumab 1mg/kg divided equally over five days with the maximum dose of 20mg per day.
16186265|NCT01499888|Drug|Sirolimus|On day -1, patients will receive a loading dose of 12 mg followed by 4 mg per day. Subsequent dosing will be based on clinical toxicity, GVHD concurrent medications, medical conditions, prior drug levels, drug-drug interactions, and blood levels with target of 3 to 12 ng/mL.
16186266|NCT01499875|Drug|Phenoxymethylpenicillin|mixture, 25 or 50 mg/kg taken once.
16186267|NCT01499862|Device|Tibion Bionic Leg|A programmable, carbon-fiber robotic leg orthosis (Tibion Bionic Leg, Tibion Corporation, Sunnyvale, CA) was used during therapy to actively supplement concentric and eccentric quadriceps function on the participant's impaired side. The device uses internal sensors at the foot and knee joint to detect intention of movement and, once a variable force threshold is passed, the devices provides appropriate assistive and resistive adjustments.
16186268|NCT01499849|Drug|Rolapitant|(4 X 50 mg capsules) 200 mg PO
16186269|NCT01499849|Drug|Granisetron|10 mcg/kg IV
16186270|NCT01499849|Drug|dexamethasone|20 mg PO and 8 mg PO
16186271|NCT01499849|Drug|Placebo|(4 X 0 mg capsules) 0 mg PO
16186272|NCT01499836|Other|PVB|paravertebral block
16186274|NCT01499797|Other|The CareWell programme|"The CareWell programme contains the following components:
~multidisciplinary primary care teams
~working with proactive care plans integrating cure, care and welfare
~advanced care planning (e.g. recording limitations of treatment, non-resuscitation decisions)
~medication review
~case-management
~guidelines for consultation of in-hospital geriatric experts
~guidelines for transfers from primary care to home-based facilities and hospital and back
~practice guidelines for management of common geriatric conditions"
16186275|NCT01499784|Behavioral|pelvic floor muscle training|behavioral modification and pelvic floor muscle training
16186276|NCT01499771|Drug|Atorvastatin|80 Mg tablets
16186277|NCT01499758|Drug|Atorvastatin|80 Mg tablets
16186278|NCT01499745|Behavioral|Pulmonary Rehabilitation|"Exercise Training in Pulmonary Rehabilitation Program:
~12 weeks of 60 min exercise bout, twice a week at pulmonary rehabilitation"
16186279|NCT01499719|Behavioral|Checklist introduction / Pause|Operating room staff will be introduced to a new checklist specifically designed to address concerns around protocols for endoscopic sinus surgery to raise awareness and attention to 11 specific areas of interest.
16186280|NCT01499706|Behavioral|1-session of telephone-administered motivational interviewing|Participants will receive a single session of telephone-delivered motivational interviewing to reduce sexual risk behavior.
16186281|NCT01499706|Behavioral|4-session telephone-administered motivational interviewing|Participants will receive four weekly sessions of telephone-delivered motivational interviewing to reduce sexual risk behavior.
16186282|NCT01499693|Drug|Magnesium Pantoprazole 20 mg|oral dose, twice a day
16186283|NCT01499693|Drug|Magnesium Pantoprazole 40 mg|oral dose, once a day (morning)
16186284|NCT01499693|Drug|Placebo|"oral dose, once a day (night)
~Placebo will be administered at night in the group with 40mg magnesium pantoprazole to keep the blinding (so treatment administration is comparable w/the 20mg group)."
16186285|NCT01499667|Drug|Fingolimod|Fingolimod 0.5 mg capsules for oral administration once daily
16186286|NCT01499667|Drug|Placebo|Matching placebo in capsules for oral administration once daily.
16186287|NCT01499654|Drug|Half-dose of the Tc99-m sestamibi (Cardiolite)|Researchers will administer half of the radiotracer (Cardiolite), obtain resting images, administer the remainder of the radiotracer and obtain a second set of resting images. Subjects will be given the same amount of radioactive material that would normally be given for this test; however, it will be administered in two ½ doses.
16186289|NCT01499628|Behavioral|Supervised Reading|Participant attends once a week for three weeks for a 45 minute appointment of supervised reading using appropriate spectacles and/or glasses
16186290|NCT01499628|Behavioral|EVT at the PRL|Eccentric viewing training at the Preferred Retinal Locus (PRL), using reading/target cards. Three 45 minute sessions completed over three weeks.
16186291|NCT01499628|Behavioral|EVT at the TRL|Participant attends once a week for three weeks for a 45 minute appointment of TRL training using the MAIA microperimeter and then further reading using magnifiers and/or spectacles.
16186292|NCT01499615|Device|cardiac monitor|All children receive the same intervention which is the application of the 4 ekg electrodes
16186293|NCT01499602|Drug|LNG-IUS; Mirena; Bayer Schering Pharma Oy, Finland|Initial release rate of 20µg Levonorgestrel per day for one year follow up.
16186294|NCT01499602|Drug|Norethisterone Acetate tablets|Norethisterone Acetate tablets at a dose of 5 mg three times daily (15mg/day) for 3 weeks over three months.With persistence of endometrial hyperplasia, the treatment is repeated for another 3 months
16186295|NCT01499589|Procedure|regional anesthesia|regional anesthesia procedure
16186296|NCT01499576|Procedure|Acetic acid chromoendoscopy|Acetic acid chromoendoscopy Spraying 1.5% acetic acid(or vinegar), during screening gastroduodenoscopy
16186297|NCT01499563|Drug|ITI-007|Capsules containing ITI-007 for 28 days
16186298|NCT01499563|Drug|Placebo|Capsules containing inactive placebo for 28 days
16186299|NCT01499563|Drug|Risperidone|Capsules containing risperidone for 28 days
16186300|NCT01499550|Device|humidified transnasal insufflation (TNI20oxy)|The alternative breathing support with TNI supplies COPD patients with 20L/min of warm humidified air. This method may be applicable to wash out the dead space between glottis and nasal opening. Pre-investigations have shown that 45 minutes of TNI during daytime reduced PCO2 and respiratory rate compared to application of oxygen alone.Transcutaneous PCO2 is measured over night. A capillary blood gas analysis (BGA) is carried out at beginning and end of each measurement night.
16186301|NCT01499550|Other|overnight oxygen treatment with individual flow rate|The patient is treated with his individual oxygene flow rate. Transcutaneous PCO2 is measured over night. A capillary blood gas analysis (BGA) is carried out at beginning and end of each measurement night.
16186302|NCT01499537|Device|biliary drainage|percutaneous transhepatic biliary drainage (PTBD)
16186303|NCT01499537|Device|EUS guided biliary drainage|endoscopic ultrasonography guided biliary drainage through the duodenal or the gastric wall
16186304|NCT01499498|Drug|Sildenafil and Boceprevir|25mg once/800mg three times a day
16186305|NCT01499485|Drug|Acetazolamide|"Daily morning ABGA:
~If actual bicarbonate > 26 mmol/L and pH > 7.35: administration of enteral capsule of acetazolamide 500 mg .
~If actual bicarbonate > 26 mmol/L and pH <= 7.35, increase minute ventilation to reach pH > 7.35 and then administer enteral capsule of acetazolamide 500 mg.
~If actual bicarbonate <= 26 mmol/L: omit treatment that day."
16186306|NCT01499485|Drug|Placebo|"Daily morning ABGA:
~If actual bicarbonate > 26 mmol/L and pH > 7.35: administration of enteral capsule of placebo.
~If actual bicarbonate > 26 mmol/L and pH <= 7.35, increase minute ventilation to reach pH > 7.35 and then administer enteral capsule of placebo.
~If actual bicarbonate <= 26 mmol/L: omit treatment that day."
16186307|NCT01499472|Device|shock wave therapy|shock wave therapy given in accordance to wound assessment every 2 weeks for 4 treatments.
16186308|NCT01499472|Device|dermagold shockwave|shock wave therapy given in accordance to wound assessment every 2 weeks for 4 treatments.
16186309|NCT01499472|Procedure|standard of care|regular care including debridement and bandaging.
16186310|NCT01499459|Genetic|autologous mesenchymal stem cell transplantation|Every patient is given 1x106 MSCs per kg infused via peripheral vein.
16186311|NCT01499446|Drug|GW685698X (fluticasone furoate) 100mcg Morning|GW685698X inhaled once daily in the morning plus placebo in the evening for 28 days
16186312|NCT01499446|Drug|GW685698X (fluticasone furoate) 100mcg Evening|GW685698X inhaled once daily in the evening fplus placebo in the morning for 28 days
16186313|NCT01499446|Drug|GW685698X (fluticasone furoate) 250mcg Evening|GW685698X inhaled once daily in the evening plus placebo in the morning for 28 days
16186314|NCT01499446|Drug|Placebo|Placebo inhaled twice daily (morning and evening) for 28 days
16186315|NCT01499433|Drug|caspofungin|Caspofungin injection, intravenously administered, loading dose at 70mg qd for the first 24hrs, maintenance dose at 50mg qd for the following 20 days
16186316|NCT01499420|Biological|CSL112 (reconstituted high density lipoprotein)|Single escalating intravenous doses of CSL112
16186317|NCT01499420|Biological|Placebo|Single intravenous doses of normal saline (0.9%)
16186318|NCT01499407|Device|ClearWay RX catheter|
16186319|NCT01499407|Drug|Abciximab|
16186320|NCT01499368|Drug|Lafutidine|Lafutidine 20mg/day
16186321|NCT01499368|Drug|Famotidine|Famotidine 40mg/day
16186322|NCT01499368|Drug|Omeprazole|Omeprazole 20mg/day
16186323|NCT01499355|Biological|BIIB023|
16186324|NCT01499355|Biological|Placebo|
16186325|NCT01499355|Drug|mycophenolate mofetil|titrated to a target daily dose of 2 g (1 g twice daily)
16186326|NCT01499355|Drug|oral corticosteroids|oral corticosteroids (prednisone or equivalent) at a target prednisone dose of 10 mg/day
16186327|NCT01499316|Procedure|High Flow oxygen|10 minute shigh flow oxygen
16186328|NCT01499316|Procedure|Room Air|Room air breathing
16186329|NCT01499303|Drug|Fostamatinib|Phase II Trial to evaluate the efficacy of 200mg fostamatinib
16186330|NCT01499290|Drug|CAZ-AVI|Ceftazidime 2000 mg and 500 mg of avibactam
16186331|NCT01499290|Drug|Metronidazole|500 mg of Metronidazole
16186332|NCT01499290|Drug|Meropenem|1 gram of Meropenem
16186333|NCT01499277|Drug|Ceftaroline fosamil|IV ceftaroline 600mg every 8 hours
16186334|NCT01499277|Drug|Vancomycin|IV vancomycin 15mg/kg every 12 hours
16186335|NCT01499277|Drug|Aztreonam|IV aztreonam 1 g every 8 hours
16186336|NCT01499264|Device|MySkin patch|Hydrogel and polyurethane film
16186337|NCT01499264|Device|Traditional Dressing|Gauze and Patch
16186338|NCT01499251|Drug|Phase 1 Dose Escalation|Macitentan 30, 60, 90 mg or higher in 30 mg dose increments, given orally, up to 150 mg, then 225 mg, 300 mg and 375 mg, unless otherwise decided by the Safety Monitoring Committee. Dose-dense temozolomide 150 mg/m2 body surface area alternating 1 week on 1 week off.
16186339|NCT01499251|Drug|Phase 1b|Macitentan given orally and daily at doses/schedule determined from the dose escalation period. Dose-dense temozolomide 150mg/m2 body surface area alternating 1 week on 1 week off.
16186340|NCT01499251|Drug|Ancillary Study|Macitentan dosed initially for 8-14 days prior to craniotomy, then treatment interrupted from time of craniotomy until 7 days before start of dose dense temozolomide therapy. dose-dense temozolomide 150 mg/m2 body surface area alternating 1 week on 1 week off.
16186341|NCT01499238|Device|Nasal SIMV|rate: 30-50/min, PIP: 16-20, PEEP: 4-6, FİO2: 40%
16186342|NCT01499238|Device|nasal CPAP|PEEP: 4-6 mmHg, FİO2: 40%
16186343|NCT01499225|Drug|YH14642 500mg Tab|YH14642 500mg per day(once a day)
16186344|NCT01499225|Drug|YH14642 500mg Tab|YH14642 1000mg per day(twice a day)
16186345|NCT01499225|Drug|YH14642 500mg Tab|YH14642 2000mg per day(three times a day)
16186346|NCT01499225|Drug|INSADOL[Zea mays L. extract] 35mg Tab|"[Initiation dose : 4weeks after administraion] INSADOL[Zea mays L. extract] 210mg TAB per day
~[Maintain dose : Between 4weeks and 8weeks after administraion] INSADOL[Zea mays L. extract] 105mg TAB per day
~[Maintain dose : Between 8weeks and 12weeks after administraion] INSADOL[Zea mays L. extract] 105mg TAB per day"
16186347|NCT01499225|Drug|DENTISTA[Doxycycline hyclate] 20mg Cap|DENTISTA[Doxycycline hyclate] Cap 40mg per day
16186348|NCT01499225|Drug|Placebo|Placebo
16186349|NCT01499212|Procedure|I:E ratio|I:E ratio 1:1 Volume controlled ventilation TV:8ml/kg EtCO2:35-40mmHg
16186350|NCT01499199|Drug|Dolutegravir|50mg Once Daily
16186351|NCT01499186|Other|Local Vibration|The subjects of the vibration group will be subjected to local vibration training by the use of custom-made cylindrical vibrators which will be placed on the hip and thigh. The subjects will apply the vibrations by themselves and they will learn how to follow the pre-programmed training program. Training sessions take place 5 times a week, during one year. The physiotherapist and the research assistant will attend the training session 1x/week. Training parameters will vary during the year to create a variable stimulus (frequency 40-80Hz and G-force 0.5-5g). The intervention group will perform all measurements.
16186352|NCT01499173|Behavioral|Stroke Preparedness Intervention|A faith-based, scientific theory-driven, peer-led behavioral intervention performed in a group setting in African American churches.
16186353|NCT01499160|Drug|letrozole|Drug is are to be taken orally. 2.5 mg once daily
16186354|NCT01499160|Drug|lapatinib|Drug is to be taken orally. 1,500 mg once daily in the first part of the study and then 1,250 mg once daily in the second part of the study (after initial progression)
16186355|NCT01499160|Drug|everolimus|Drug is to be taken orally. 5 mg once daily.
16186356|NCT01499147|Drug|fludarabine/busulfan|All patients below age 55, should receive fludarabine/busulfan, and ATG in case of unrelated or mismatched donor, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl) and/or specific medical conditions such as preventing a standard myeloablative treatment, as per discussion with the PI.
16186357|NCT01499147|Drug|fludarabine/ melphalan|All patients above age 55 or below age 65, should receive fludarabine/melphalan, and ATG, unless there is significant pulmonary, hepatic or cardiac damage: (E.g FEV1 <40%, DLCO<50%, LVEF<40, Serum bilirubin >1.5 mg% or serum transaminases > 2x nl).
16186358|NCT01499147|Drug|ATG|Patients receiving a transplant from a matched unrelated or mismatched related/unrelated donor would receive ATG in the conditioning regimen.
16186359|NCT01499134|Drug|nebivolol|Study medication will initially be dispensed as one capsule daily and the dose will be titrated at the study visits. Nebivolol is approved for hypertension treatment at a dose of 5-40 mg daily. Based on the study titration schedule, the maximum doses used will be 20 mg of nebivolol (each maximum dose being contained in 4 capsules for daily dosing).
16186360|NCT01499134|Drug|Metoprolol succinate|Study medication will initially be dispensed as one capsule daily and the dose will be titrated at study visits. Metoprolol succinate at 25-400 mg daily. Based on the study titration schedule, the maximum dose used will be 200 mg of metoprolol succinate (each maximum dose being contained in 4 capsules for daily dosing).
16186361|NCT01499121|Drug|Sunitinib|The starting dose will be 50 mg Sunitinib on the 28/14 schedule. In patients that develop ≥ grade-2 toxicity after 2 weeks, therapy will be held for 7 days or resolution before continuing therapy according to the 1st dose/schedule change. In patients that do not develop ≥ grade-2 toxicity, therapy will continue for 1-2 weeks or until ≥ grade-2 toxicity. In patients that develop > grade-2 toxicity after less than 4 weeks, therapy will be held for 7 days or before continued according to the 1st dose/schedule change. Patients that do develop grade-2 toxicity (but no more) on the 50 mg 28/14 schedule, will remain on schedule but the time off therapy will be reduced to 7 days if toxicity has resolved after a 7-day break. Patients that develop ≤ grade-1 toxicity on the 50 mg 28/14 schedule, will be dose escalated according to protocol.
16186362|NCT01499108|Drug|liraglutide|Subcutaneous injection of liraglutide at doses of 0.6, 1.2, and 1.8 mg once daily during the 49 days duration of the study
16186363|NCT01499095|Drug|Lantus (Insulin glargine)|Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months in combination with oral antidiabetic drug(s). Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).
16186364|NCT01499095|Drug|HOE901-U300 (new formulation of insulin glargine)|HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily (evening) for 12 months in combination with oral antidiabetic drug(s). Dose titration seeking fasting plasma glucose 4.4 - 5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter [mg/dL]). After 6 months participants were proposed to participate to the administration substudy and to receive either HOE901-U300 once daily at intervals of 24 +/- 3 hours (adaptable dosing intervals) or to continue once daily injections of HOE901-U300 every 24 hours (fixed dosing intervals) up to Month 9.
16186365|NCT01499082|Drug|HOE901-U300 (new formulation of insulin glargine)|HOE901-U300 (new insulin glargine 300 units per milliliter [U/mL]) subcutaneous (SC) injection once daily (evening) for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 millimole per liter (mmol/L) (80 - 100 milligram per deciliter [mg/dL]). After 6 months participants were proposed to participate to the administration substudy and to receive either HOE901-U300 once daily at intervals of 24 +/- 3 hours (adaptable dosing intervals) or to continue once daily injections of HOE901-U300 every 24 hours (fixed dosing intervals) up to Month 9.
16186410|NCT01498770|Drug|Paliperidone|Paliperidone prescribed as recorded in the CPRD in the UK
16186366|NCT01499082|Drug|Lantus (insulin glargine)|Lantus (HOE901-U100, insulin glargine 100 U/mL) SC injection once daily (evening) for 12 months on top of mealtime insulin analogue. Dose titration seeking fasting plasma glucose 4.4-5.6 mmol/L (80 - 100 mg/dL).
16186367|NCT01499069|Drug|Oxybutinin, Fesoterodine, Solifenacin, Propiverin, Trospium|"Dosage and frequency can be adjusted according to the patients' symptoms based on the instruction for administration .
~Duration; 3 or 6 months"
16186368|NCT01499056|Biological|stem cell injection|intra articular inection of mesenchymal stem cell
16186369|NCT01499043|Drug|PLX3397|Capsules administered twice daily, continuous dosing. Subjects will take PLX3397 at 1000 mg/day.
16186370|NCT01499017|Drug|PF-06291874 or placebo|PF-06291874 will be administered as an extemporaneously prepared suspension for all doses within the initially planned range of 3 mg to 100 mg. Correspondingly, placebo doses will be administered as suspension.
16186371|NCT01499017|Drug|PF-06291874 or Placebo|PF-06291874 will be administered as an extemporaneously prepared suspension for all doses within the initially planned range of 300 mg to 650 mg. Correspondingly, placebo doses will be administered as suspension.
16186372|NCT01499004|Drug|tofacitinib (CP-690,550) modified-release formulation A|A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered with food.
16186373|NCT01499004|Drug|tofacitinib (CP-690,550) modified-release formulation B1|A single dose of 22 mg tofacitinib (CP-690,550) MR-B1 formulation administered with food
16186374|NCT01499004|Drug|tofacitinib (CP-690,550) modified-release formulation A|A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation A administered without food
16186375|NCT01499004|Drug|tofacitinib (CP-690,550) modified-release formulation B1|A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B1 administered without food
16186376|NCT01499004|Drug|tofacitinib (CP-690,550) modified-release formulation B2|A single dose of 22 mg tofacitinib (CP-690,550) modified-release formulation B2 administered without food
16186377|NCT01499004|Drug|tofacitinib (CP-690,550) immediate-release formulation|A single dose of 10 mg tofacitinib (CP-690,550) immediate-release formulation administered without food
16186378|NCT01498991|Device|AMES Treatment|The AMES device rotates the ankle over a range of 30 degrees while vibrators stimulate the tendons attached to muscles that move the leg. Each participant will receive treatment of both lower extremities. Treatment of the 2 legs will be scheduled to run in the same session. The subject's task is to assist the motion of the device. The AMES treatment device couples assisted movement and tendon vibration (enhanced sensation) in 30 treatments which will each run approximately 40 minutes (20 minutes on the right leg and 20 minutes on the left leg).
16186379|NCT01498978|Biological|ipilimumab|Given IV
16186380|NCT01498978|Other|laboratory biomarker analysis|Correlative studies
16186381|NCT01498952|Drug|MEDI-573 (1 of 3 doses)|MEDI-573, a human immunoglobulin G2 lambda (IgG2λ) monoclonal antibody (MAb), is a dual-targeting human antibody that neutralizes insulin-like growth factor (IGF)-I and IGF-II ligands
16186382|NCT01498952|Drug|Sorafenib|Sorafenib is a tyrosine kinase inhibitor, anti-angiogenic, VEGF inhibitor
16186383|NCT01498939|Drug|insulin detemir|Each subject will be randomly allocated to an insulin detemir dosing sequence. Three doses of insulin detemir (0.2, 0.4 or 0.8 U/kg) will be administered on three inconsecutive days with a wash-out period between each dosing. Injected subcutaneously (s.c., under the skin)
16186384|NCT01498926|Drug|insulin detemir|Single dose containing mannitol as isotonic agent. Administered subcutaneously (s.c., under the skin)
16186385|NCT01498926|Drug|insulin detemir|Single dose containing glycerol as isotonic agent. Administered subcutaneously (s.c., under the skin)
16186386|NCT01498913|Drug|repaglinide|Prescription with NovoNorm® 0.5mg, 1mg or 2mg tablets according to product labelling in daily clinical practice at the discretion of the physician
16186387|NCT01498900|Drug|repaglinide|Prescription according to the product labelling at the physicians' discretion
16186388|NCT01498887|Drug|Fingolimod (FTY720)|Hard gelatin capsules containing 0.5 mg of fingolimod.
16186389|NCT01498874|Drug|Placebo|Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56
16186390|NCT01498874|Drug|gevokizumab|Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56
16186391|NCT01498874|Drug|gevokizumab|Sterile solution administered subcutaneously on Day 0, Day 28, and Day 56
16186392|NCT01498861|Drug|Ortho-Cyclen|Ortho-cyclen is an oral contraceptive.
16186393|NCT01498861|Drug|Dolutegravir|Dolutegravir is an experimental HIV drug
16186394|NCT01498861|Drug|Placebo|Placebo is a tablet with no drug in it
16186395|NCT01498848|Dietary Supplement|Cooking oils|Families were randomized to receive either soybean or sunflower oil for cooking during 4 weeks
16186396|NCT01498835|Drug|Sunitinib|"Patients will receive Sunitinib daily for 2 weeks prior to and then concurrently with irradiation as neoadjuvant treatment. Radiotherapy will be given as intensity modulated radiation therapy with a total dose of 50.4Gy in 28 fractions to each patient (5 1/2 weeks).
~Sunitinib will be given in two dose levels. The first dose level will be 25mg Sunitinib per os daily. The second dose level will be 37.5mg sunitinib per os daily. A dose modification schedule according to a 3+3 design will be applied for patient accrual."
16186397|NCT01498822|Drug|Levetiracetam|250 mg and 500 mg Levetiracetam tablet, 1000 mg-3000 mg/day, maximum 50 weeks including initial up titration of 500 mg/day for 2 weeks
16186398|NCT01498822|Drug|Oxcarbazepine|150 mg and 300 mg Oxcarbazepine tablet, 900 mg-2400 mg/day, maximum 50 weeks including 2 weeks of up titration (300 mg/day 1week then 600 mg/day 1 week)
16186399|NCT01498809|Drug|Midodrine|Single 10 mg dose
16186400|NCT01498796|Drug|Ketorolac|
16186401|NCT01498796|Drug|Normal Saline|
16186402|NCT01498783|Drug|5-fluorouracil|5-fluorouracil, bolus dose of 500 mg/m^2 given weekly for 4 weeks followed by a two week rest period equals one cycle (6 weeks). Therapy may continue for up to 16 cycles (about 2 years).
16186403|NCT01498770|Drug|Asenapine|Asenapine prescribed as recorded in the CPRD in the UK
16186404|NCT01498770|Drug|Aripiprazole|Aripiprazole prescribed as recorded in the CPRD in the UK
16186405|NCT01498770|Drug|Quetiapine|Quetiapine prescribed as recorded in the CPRD in the UK
16186406|NCT01498770|Drug|Risperidone|Risperidone prescribed as recorded in the CPRD in the UK
16186407|NCT01498770|Drug|Olanzapine|Olanzapine prescribed as recorded in the CPRD in the UK
16190987|NCT01464502|Procedure|Standard CRT Implant|
16186412|NCT01498770|Drug|Clozapine|Clozapine prescribed as recorded in the CPRD in the UK
16186413|NCT01498770|Drug|Amisulpride|Amisulpride prescribed as recorded in the CPRD in the UK
16186414|NCT01498770|Drug|Sertindole|Sertindole prescribed as recorded in the CPRD in the UK
16186415|NCT01498770|Drug|Zotepine|Zotepine prescribed as recorded in the CPRD in the UK
16186416|NCT01498744|Drug|Oral Clindamycin|Based on our preliminary susceptibility data, oral clindamycin (10mg/kg up to 300 mg, every 8 hours) is the first line of antibiotic. Patients allergic or intolerant to clindamycin will receive oral trimethoprim-sulfamethoxazole [bactrim] (5mg/kg trimethoprim up to 160 mg, every 12 hours).
16186417|NCT01498731|Behavioral|Discharge home|Patients who test negative for Copeptin at admission will be considered low-risk and will be discharged home. To secure the patients safety they will be transferred into our co-operating network of resident cardiologists preferably the next day (but latest within the next three days). In case of any findings suggestive of acute coronary syndrome or worsening of the patient's condition, the patient will immediately be re-admitted to our Emergency Room.
16186418|NCT01498718|Biological|DNA vaccine|VRC-FLUDNA061-00-VP is composed of 3 closed-circular DNA plasmids that encode for the hemagglutinin (HA) from the following 3 strains: A/California/04/2009 (H1N1); A/Perth/16/2009 (H3N2), and B/Brisbane/60/2008. DNA vaccine vials will be supplied at 4 mg/mL and each dose will be 1 mL.
16186419|NCT01498718|Biological|TIV|2012/13 Seasonal Influenza Trivalent Inactivated Vaccine (TIV)
16186420|NCT01498705|Other|Procalcitonin level|PCT level upon admission and on days 1, 3, and 5 following baseline level
16186421|NCT01498692|Device|PROMUS Element Coronary Stent System|PROMUS Element is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating)
16186422|NCT01498679|Drug|GW685698/GW642444 (fluticasone furoate/vilanterol trifenatate)|ICS/LABA combination (100/25mcg) administered once daily in the evening via a Novel Dry Powder Inhaler (NDPI)
16186423|NCT01498679|Drug|Placebo|Placebo administered once daily in the evening via a NDPI
16186424|NCT01498666|Dietary Supplement|L. reuteri protectis|1 tablet once daily for 4 weeks
16186425|NCT01498666|Dietary Supplement|Placebo tablet|1 tablet once daily for 4 weeks
16186426|NCT01498653|Drug|GW685698/GW642444|ICS/LABA
16186427|NCT01498653|Drug|CCI18781|ICS
16186428|NCT01498640|Biological|Collagenase clostridium histolyticum|up to three 0.58 mg injections
16186429|NCT01498627|Biological|Cervarix|3 doses over a period of 6 months (Month 0 and ideally Month 1 and Month 6, with 1 month minimum between any two doses).
16186430|NCT01498627|Other|Data collection|PGRx information system
16186431|NCT01498614|Behavioral|Affect School and Basal body awareness|Affect School is an educational method based on SS Tomkins affect theory and Basal Body Awareness therapy is an educational stress reducing method
16186432|NCT01498601|Other|Enhanced oral care protocol|"Changing mouth suction equipment every 24 hours
~Mouth assessment every 2-4 hours
~Cleansing mouth with toothbrush every 12 hours
~Cleansing oral mucosa with oral rinse solution every 2-4 hours
~Moisturize mouth/lips with swab and standard mouth moisturizer every 4 hours
~Suction mouth and throat as needed
~Head of the bed elevated to a minimum of 30° during oral care"
16186433|NCT01498588|Drug|Eribulin|Patients will receive 4 cycles of neoadjuvant eribulin followed by 4 cycles of dose-dense doxorubicin and cyclophosphamide (AC).
16186434|NCT01498588|Drug|Doxorubicin|Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide
16186435|NCT01498588|Drug|Cyclophosphamide|Neoadjuvant eribulin followed by dose-dense doxorubicin and cyclophosphamide
16186436|NCT01498588|Drug|Pegfilgrastim|Growth factor support (pegfilgrastim) can be given at the discretion of the investigator. Administration of pegfilgrastim is required 24 to 48 hours following administration of dose-dense doxorubicin and cyclophosphamide.
16186437|NCT01498575|Behavioral|Teen driving plan|Web-based intervention designed to facilitate parent supervised practice driving with novice teen driver.
16186438|NCT01498562|Drug|Gefitinib and Nimotuzumab|Combination therapy group: Gefitinib(250mg daily) + Nimotuzumab (200mg weekly)
16186439|NCT01498562|Drug|Gefitinib|Mono-therapy group: Gefitinib(250mg daily)
16186440|NCT01498549|Drug|Atomoxetine|Atomoxetine 40mg and 80mg compared to the sugar pill
16186441|NCT01498549|Drug|Sugar Pill|Sugar pill compared to Atomoxetine 40mg and 80mg.
16186442|NCT01498536|Behavioral|aerobic exercise|3 times per week for 12-weeks
16186443|NCT01498523|Other|Camel milk|600ml of raw camel milk will be consumed in 10 minutes. the blood glucose concentrations will be measured at 0, 15, 30, 45, 60 ,90 and 120 minutes by finger-prick blood samples. Also, blood insulin and amino acids concentration will be measured at 0, 30 and 75 minutes.
16186444|NCT01498523|Other|camel milk powder solution|72g camel milk powder will be dissolved in 540ml water to make 600ml camel milk powder solution. This will be consumed in 10 minutes. the blood glucose concentrations will be measured at 0, 15, 30, 45, 60 ,90 and 120 minutes by finger-prick blood samples. Also, blood insulin and amino acids concentration will be measured at 0, 30 and 75 minutes.
16186445|NCT01498523|Other|raw cow milk|50ml water will be added to 550ml raw cow milk to make 600ml cow milk. This will be consumed in 10 minutes. the blood glucose concentrations will be measured at 0, 15, 30, 45, 60 ,90 and 120 minutes by finger-prick blood samples. Also, blood insulin and amino acids concentration will be measured at 0, 30 and 75 minutes.
16186446|NCT01498523|Other|Glucose solution|25g glucose will be dissolved in 600ml water, and this will be consumed in 10 minutes. the blood glucose concentrations will be measured at 0, 15, 30, 45, 60 ,90 and 120 minutes by finger-prick blood samples. Also, blood insulin and amino acids concentration will be measured at 0, 30 and 75 minutes.
16186447|NCT01498510|Behavioral|Web-based CBT for chronic pain|An interactive, web-based intervention, based on principles of cognitive behavior therapy (CBT), that is designed to train chronic pain patients in self-management skills to reduce pain and aberrant behavior and improve functioning
16186448|NCT01498497|Drug|EUR-1100|
16186449|NCT01498497|Drug|Placebo|
16186450|NCT01498484|Biological|EBV-specific T cells (EBV-CTLs)|EBV-CTLs are cytotoxic T lymphocytes that specifically kill cells presenting EBV protein antigens including EBV-transformed B lymphocytes responsible for EBV-associated lymphomas and lymphoproliferative disorders.
16186483|NCT01498211|Procedure|Biopsy|3 mm punch biopsy of the skin at the distal leg.
16186451|NCT01498458|Drug|Pazopanib plus capecitabine|"Patients will receive pazopanib tablets once daily at a dose according to the allocated dose level:
~dose level I: 400 mg
~dose level II: 600 mg
~dose level III: 800 mg
~In addition patients receive capecitabine at the same oral dose for all dose levels with 1600 mg/m2 on days 1 to 14 every 3 weeks.
~Treatment will be given until disease progression or unacceptable toxicity of the study drug, or withdrawal of consent of the patient.
~Six patients will be recruited in each dose level. If less than 2 out of 6 patients experience a DLT within the first 2 cycles (weeks 1 to 6), the next dose level is started. Once the MTD is established, additional 6 patients will be included into this dose level to further characterise the safety of the dose regimen.
~If it is reported, that two patients had a DLT, all patients are informed about it and the dose level immediately reduced by one dose level."
16186452|NCT01498445|Drug|Dasatinib|Starting Dose: 100 mg by mouth once daily of a 28 day cycle.
16186453|NCT01498445|Drug|Decitabine|Starting Dose (less intensive group) Schedule A: 10 mg/m2 by vein daily for 10 days of a 28 day cycle.
16186454|NCT01498445|Drug|Decitabine|Starting Dose (more intensive group) Schedule B: 20 mg/m2 by vein daily for 10 days of a 28 day cycle.
16186455|NCT01498432|Drug|Heliox21|For Heliox21 the percentage of O2 will match the percentage of O2 prior to extubation, and Helium will make up the remainder (e.g. Helium 65% + O2 35%), and the O2 concentration will be titrated as their clinical condition indicates (as O2 increases Helium will decrease and vice versa).
16186456|NCT01498432|Drug|Air O2|For Air-O2 the percentage of O2 delivered will match the patient's percentage of O2 prior to extubation, and will be titrated as their clinical condition indicates.
16186457|NCT01498419|Drug|Moxifloxacin (M)|
16186458|NCT01498419|Drug|Pretomid (Pa)|
16186459|NCT01498419|Drug|Pyrazinamide (Z)|
16186460|NCT01498419|Drug|Rifafour|Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: 2 tablets, 38-54 kg: 3 tablets, 55-70 kg: 4 tablets: 71 kg and over: 5 tablets
16186461|NCT01498406|Dietary Supplement|vitamin D|The investigators will carry out a two-armed prospective pilot study of the influence of vitD on cutaneous lupus (CLE) disease severity. Patients with CLE will be eligible for an observational or interventional arm based on their 25(OH)D levels and consent. Subjects with low vitD status (<30 ng/mL) will be eligible for the investigational arm involving participation in a randomized controlled trial of daily high dose (4000 IU) vs. low dose (400 IU) vitD supplementation for 8 months. Subjects who have sufficient vitD status (>30ng/mL) or those with low vitD who choose not to participate in the RCT are eligible for continued participation in the observational arm of the study. All subjects will be followed at 4, 8, and 12 months.
16186462|NCT01498393|Device|Laser treatment|Laser treatment to Improve the Appearance of Onychomycosis
16186463|NCT01498380|Drug|Dexmedetomidine|The bolus dose of dexmedetomidine given will range from 0.25-2.0 mcg/kg and will be based on the up-and-down method, such that subject 1 will receive 0.5 mcg/kg and if no significant hemodynamic changes occur (heart rate decrease < 20% or blood pressure decrease/increase < 20%) the does will be increased by 0.25 mcg/kg for the subsequent subject. If significant hemodynamic changes occur (HR decrease >/= 20% or SBP/DBP/MAP decrease or increase >/= 20%) the dose will be decreased by 0.25 mcg/kg for the subsequent subject. Each subject will be observed for 10 minutes following the dexmedetomidine bolus.
16186464|NCT01498367|Procedure|Telemonitoring of patients with diabetes type 2|Telemonitoring of the patients's blood glucose level measurements using a the tele-glucose meter
16186465|NCT01498354|Procedure|2-D high definition vision systems, transanal endoscopic operation (TEO)|Transanal endoscopic operation (TEO). Through its 2-D vision system using a rectoscope, this procedure allows access to rectal tumors located up to 20 cm from the anal verge
16186466|NCT01498354|Procedure|Transanal endoscopic microsurgery (TEM)|Transanal endoscopic microsurgery (TEM). 3-D vision system using a rectoscope, allowing access to rectal tumors located up to 20 cm from the anal verge
16186467|NCT01498328|Drug|Bevacizumab|A vascular endothelial growth factor (VEGF)-specific humanized monoclonal antibody angiogenesis inhibitor. Infusions of 10 mg/kg of bevacizumab will begin on day 1 and will be administered every two weeks until progression of disease or intolerance during the treatment period.
16186468|NCT01498328|Drug|Rindopepimut (CDX-110) with GM-CSF|Rindopepimut/GM-CSF will initially be given three times, two weeks apart, followed by monthly injections until tumor progression or intolerance. Each dose will be 0.8 mL containing approximately 500 mcg CDX-110 and 150 mcg GM-CSF.
16186469|NCT01498328|Drug|KLH|KLH will initially be given three times, two weeks apart, followed by monthly injections until tumor progression or intolerance. Each dose will be 0.8 mL containing approximately 100 mcg of KLH.
16186470|NCT01498315|Other|Ultrasound examination|Ultrasound examination following hysterectomy
16186471|NCT01498302|Other|diagnostic laboratory biomarker analysis|
16186472|NCT01498302|Other|flow cytometry|
16186473|NCT01498289|Drug|FOLFOX regimen|Given IV. Fluorouracil, oxaliplatin, & leucovorin calcium.
16186474|NCT01498289|Drug|docetaxel|30 mg/m^2, IV over 30 minutes on Day 1,8 of each 21 day cycle.
16186475|NCT01498289|Drug|fluorouracil|400 mg/m^2, IV bolus on Day 1 of each 14 day cycle; 2400 mg/m^2 IV over 46-48 hours on Days 1-2 of each 14 day cycle.
16186476|NCT01498289|Drug|irinotecan hydrochloride|65 mg/m^2, IV over 90 minutes on Days 1 & 8 of every 21 day cycle.
16186477|NCT01498289|Drug|leucovorin calcium|400 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.
16186478|NCT01498289|Drug|oxaliplatin|85 mg/m^2, IV over 2 hours on Day 1 of every 14 day cycle.
16186479|NCT01498237|Device|Photoacoustic endoprobe|The PAE assessment will be performed in the operating room following strict sterile technique. PAE is performed immediately prior to the planned surgery. Participants are prepped following standard protocol. Length of the endometrial cavity is determined by a uterine sound. Endocervix is dilated as needed to allow passage of the PAE probe. The PAE probe will be advanced to the uterine fundus. Images will be obtained during withdrawal of the PAE probe from fundus to the os. Recorded images will allow computer assisted image analysis and functional measurements to be performed. Duration and difficulty of the procedure will be recorded. Comments and complications will be specifically noted.
16186480|NCT01498237|Procedure|Photoacoustic endoscopy|Photoacoustic endoscopy probe will be inserted into the endometrial canal to the uterine fundus and images will be obtained during the withdrawal of the probe from the fundus to the endocervical os.
16186481|NCT01498224|Device|ReSure Sealant|Comparison of ReSure Sealant to suture(s)
16186482|NCT01498224|Procedure|Sutures|
16186484|NCT01498198|Procedure|Rotator Cuff Repair Surgery|Participants will have surgery within 3 months. They will be followed up at 6 weeks, 12 weeks, 6 months and 12 months pos operatively.
16186485|NCT01498198|Other|Non Operative Treatment|Participants will undergo a 6 week assessment, and if they are improving they will continue undergoing non operative care up until 12 months. If at any assessment point (6 weeks, 12 weeks, 6 months, 12 months) they are deemed to not be making any more progression, they will be referred back to the surgeon.
16186486|NCT01498185|Drug|Dapagliflozin|Tablets, Oral, 1 mg, Once daily, 14 days
16186487|NCT01498185|Drug|Placebo matching Dapagliflozin|Tablets, Oral, 0 mg, Once daily, 14 days
16186488|NCT01498172|Biological|MAGE-A3 ASCI|5 doses every 3 weeks
16186489|NCT01498172|Biological|BCG|1 intravesical dose /week for 6 weeks
16186490|NCT01498159|Behavioral|Pharmacist disease/medication management|
16186491|NCT01498159|Behavioral|Pharmacist-patient encounters|
16186492|NCT01498159|Behavioral|Pharmacist medication intensification and adherence support|
16186493|NCT01498159|Behavioral|Pharmacist communication with primary care physicians|
16186494|NCT01498159|Behavioral|Pharmacist documentation in electronic medical record|
16186495|NCT01498159|Behavioral|Health promoter-patient encounters in-person or by phone|
16186496|NCT01498159|Behavioral|Health promoter medication and lifestyle support|
16186497|NCT01498159|Behavioral|Health promoter communication with pharmacists|
16186498|NCT01498133|Procedure|skin-to skin contact|Skin-to-skin contact consisted of placing the infant slightly worn (only diapers) in prone decubitus, upright against the mother's breast. The infant was restrained in position by a track that involved him with his/her mother. The mother sat in a chair positioned beside the infants' bed. A team member that accompanied the intervention monitored infants' temperature, heart rate and oxygen saturation.
16186499|NCT01498120|Drug|Rotigotine|"Optimal dose after titration period
~0.5 mg/24 h (2.5 cm^2)- 1 mg/24 h (5 cm^2)- 2 mg/24 h (10 cm^2)- 3 mg/24 h (15 cm^2)
~1 patch /day"
16186500|NCT01498107|Behavioral|SilverCloud Platform|The SilverCloud online intervention will be provided as an alternative choice to paper manuals to support guided self-help for depression in a primary care mental health service. Participants will receive up to eight progress reviews on a weekly or fortnightly basis as agreed with their therapist with the intervention running not more than three months.
16186501|NCT01498094|Procedure|High Flow Nasal Cannula Oxygen Therapy|Warm humidified oxygen will be delivered at 8 liters/minute via nasal cannulae, at a concentration that maintains saturations greater than 92%.
16186502|NCT01498094|Other|Standard low flow oxygen|Standard low flow oxygen will be given to patients to maintain saturations greater than 92%.
16186503|NCT01498081|Drug|AZD2115|AZD2115 administered via inhalation
16186504|NCT01498081|Drug|Placebo|Placebo administered via inhalation
16186505|NCT01498081|Drug|Indacaterol|Indacaterol administered via inhalation
16186506|NCT01498081|Drug|Indacaterol + Tiotropium|Indacaterol + Tiotropium administered inhalation
16186507|NCT01498068|Drug|Telaprevir|Telaprevir Type = exact number, unit = mg, number = 750, form = tablet, route = oral. Telaprevir 750 mg (2 oral tablets) is taken every 8 hours for 12 weeks
16186508|NCT01498068|Drug|Pegylated-interferon-alfa-2a|Pegylated-interferon-alfa-2a type = exact number, unit = microgram, number = 180, form = injection, route = subcutaneous. 180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks
16186509|NCT01498068|Drug|Ribavirin|Ribavirin Type = exact, number = 1000 or 1200, unit = mg, form = tablet, route = oral. 1000mg (if participant's weight is < 75kg) or 1200mg (if participant's weight is >= 75kg) per day for 24 or 48 weeks.
16186510|NCT01498029|Procedure|Microfracture|The microfracture procedure is a standard method for treatment of cartilage damage in which the surgeon will clean the site of your cartilage damage and then will make several small holes in your bone to stimulate your bone marrow with the intention to repair the damaged area with new cartilage tissue
16186511|NCT01498029|Device|Cartilage Autograft Implantation System (CAIS)|The Cartilage Autograft Implantation System (CAIS) is a kit of devices that utilizes morselized autologous hyaline cartilage harvested arthroscopically, affixed onto a synthetic, resorbable implant using a fibrin sealant and implanted in a single surgical procedure. The system is designed as a surgical treatment of damaged knee cartilage using the subject's own healthy cartilage obtained from a non-weight or low weight-bearing region.
16186512|NCT01498016|Drug|Busulfan|Iv busulfan 1.6mg/kg q12h D1- D4
16186513|NCT01498003|Drug|tirofiban|10μg/kg bolus followed by 0.15μg/kg/min maintenance infusion for 12h
16186514|NCT01498003|Drug|normal saline solution|same use as tirofiban
16186515|NCT01497990|Drug|Ertapenem|The patient received two injections of ertapenem, at a dose of 1g.j-1 by intravenous injection of 30 minutes, separated by 24 h.
16186516|NCT01497977|Drug|phytoestrogens|The red clover capsule consisted of 4 isoflavones: biokain A (23mg), daidzein (1mg), formononetin (15mg) and genistein (1mg).
16186517|NCT01497977|Drug|phytoestrogens|The soya daily dose contained 2 isoflavones: genistein (39mg) and daidzein (1mg).
16186518|NCT01497964|Drug|cabazitaxel XRP6258|Pharmaceutical form: solution for infusion Route of administration: intravenous
16186519|NCT01497951|Other|Aminolaevulinic acid|Photodynamic therapy
16186520|NCT01497951|Other|Methylcellulose Placebo|Methylcellulose
16186521|NCT01497938|Device|Medtronic MMT-754 Veo Insulin pump testing Low Glucose Suspend (LGS) feature|Automatic suspension of insulin delivery when glucose is low.
16186522|NCT01497938|Device|Medtronic (NO LGS FEATURE ) using Paradigm® Revel™2.0 Pump|No Automatic suspension of insulin delivery when glucose is low.
16186523|NCT01497925|Drug|ADI-PEG 20|Dosage: 4.5, 9, 18 and 36 mg/m2. Frequency: weekly.
16186524|NCT01497912|Drug|Atorvastatin|Atorvastatin 80mg once daily for 8 weeks
16186525|NCT01497912|Drug|Placebo|Placebo tablet once daily for 8 weeks
16186526|NCT01497899|Drug|E/C/F/TDF|150/150/200/300 mg FDC tablet administered orally once daily
16186527|NCT01497899|Drug|E/C/F/TAF Placebo|Tablet administered orally once daily
16186528|NCT01497899|Drug|E/C/F/TAF|150/150/200/10 mg FDC tablet administered orally once daily
16186529|NCT01497899|Drug|E/C/F/TDF Placebo|Tablet administered orally once daily
16186530|NCT01497886|Behavioral|Hip Hop Stroke educational program|Three one-hour sessions, conducted over three consecutive days
16186531|NCT01497886|Behavioral|Nutrition Education program|"The investigators will use what they will refer to as a usual care control. For this purpose the investigators have selected nutrition, physical activity, and obesity education. A trained facilitator will conduct the control program in the school auditorium. The investigators will use this control method to control for attention, i.e., having a facilitator come to the classroom for the same amount of time as in the intervention that is, 1-hour sessions on three consecutive days. The facilitator will provide focused lectures on relevant topics, and show two short, 4-minute animated films on nutrition, and physical activity. The investigator will conduct parallel pretests and post-tests on the children (same as intervention testing sequence)."
16186532|NCT01497873|Drug|Topotecan|1.5 mg/m^2 IV days 1, 2, 3, 4, 5 of each 21-day cycle until 6 cycle or more
16186533|NCT01497873|Drug|Belotecan|0.5 mg/m^2 IV days 1, 2, 3, 4, 5 of each 21-day cycle until 6 cycle or more
16186534|NCT01497860|Drug|Vinorelbine|IV Vinorelbine (6mg/m2) provided once a week for 6 weeks followed by a 2 week rest (6 of every 8 weeks) for one year. Progression free survival will be monitored for 60 months.
16186535|NCT01497834|Drug|BMS-790052 (Daclatasvir)|Tablets, Oral, 60mg, Once daily, 24 weeks
16186536|NCT01497834|Drug|BMS-650032 (Asunaprevir)|Capsules, Oral, 100mg, Twice daily, 24 weeks
16186537|NCT01497821|Drug|AMG 172|AMG 172 is an antibody drug conjugate
16186538|NCT01497808|Drug|Ipilimumab|
16186539|NCT01497808|Radiation|Stereotactic Body Radiation Therapy|
16186540|NCT01497782|Other|Instructor feedback|Intervention group who receives up to three sessions of instructor feedback during completion of a predefined proficiency level on a laparoscopic virtual reality simulator.
16186541|NCT01497769|Biological|Aerosol inhaled MVA85A|Aerosol inhaled MVA85A 1 x 10^7 pfu and intradermal saline placebo
16186542|NCT01497769|Biological|Intradermal MVA85A|Intradermal MVA85A 1 x 10^7 pfu and inhaled aerosol saline placebo
16186543|NCT01497756|Device|CAPP use|Any abdominal pelvic pressure
16186544|NCT01497743|Drug|Lactobacillus|All randomized subjects will receive probiotic or matching placebo: 1 capsule orally twice daily, with meals) for the first 4 weeks. There will be a 6-week washout period, followed by 4 weeks of the alternate treatment. The subject will not be on study medication during this washout period.
16186545|NCT01497730|Device|Total Knee Replacement|"Subjects will receive one of the following total knee implants:
~PFC Sigma Fixed Bearing (FB) cruciate retaining (CR), posterior stabilized (PS) or Rotating Platform CR or PS devices. LCS Rotating platform or PS devices. Triathlon CR, PS or mobile bearing devices. NexGen CR, LPS, LPS Flex FB PS, LPS Flex Mobile bearing, or LPS Mobile bearing devices."
16186546|NCT01497717|Drug|Adalimumab (Humira)|"Open label pilot trial.
~The study includes 3 phases :
~Open label treatment period of 24 weeks.
~Extension follow -up (3 years): Patients who responded well to study drug and their disease relapsed within the first 12 weeks following study drug interruption will be eligible to receive the study drug for 3 years in order to comply with the Israeli Ministry of Health requirements.
~Safety follow-up: For patients who withdraw from either the open label treatment period or extension period, for another 24 weeks."
16186547|NCT01497704|Drug|YN968D1|Daily dosing of YN968D1 for treatment of solid tumors
16186548|NCT01497691|Device|NIPPV (PALMtop PTV)|PALMtop PTV Models 8/10 aka CareFusion EnVe The primary study device is the PALMtop PTV. It is the NIPPV/BiPAP device used in this study. It is FDA approved for use in children who weigh 5 kilograms or greater (#K070594).
16186549|NCT01497691|Device|Volumetric CO2 (NM3)|The NM3 is FDA approved (#K091459) for spirometric and carbon dioxide monitoring as well as continuous, non-invasive monitoring of arterial oxygen saturations and pulse rates in neonatal and pediatric patients in the emergency department.
16186550|NCT01497691|Device|USCOM|The USCOM a non-invasive ultrasonic device that is FDA approved for monitor beat-to-beat cardiac hemodynamics in adult and pediatric patients (#K043139). It will be used in an attempt to better understand the underlying physiology of NIPPV use.
16186551|NCT01497678|Device|Extracellular Matrix|Extracellular Matrix
16186552|NCT01497665|Drug|GRN1005|650 mg/m2 IV every 3 weeks
16186553|NCT01497652|Drug|Rasagiline/Placebo|Will receive placebo pills each day for the entire 14 weeks.
16186554|NCT01497652|Drug|Rasagiline|0.5 mg for two weeks, then 1 mg for 12 weeks.
16186555|NCT01497639|Device|Interleaving stimulation mode (Medtronic)|Interleaving stimulation mode with constant frequency (125 Hz) and pulse-width (120us)parameters 'Interleavingr stimulation mode (Medtronic)'
16186556|NCT01497639|Device|Double monopolar stimulation mode (Medtronic)|Double monopolar stimulation mode with constant frequency (125 Hz) and pulse-width (120us)parameters 'Double monopolar stimulation mode (Medtronic)'
16186557|NCT01497626|Drug|Lapatinib and bortezomib|"Lapatinib will be taken orally continuously for 28 days of each 28-day cycle, including a run-in of lapatinib alone day -7 to day 1 of cycle 1.
~Bortezomib will be administered IV on days 1, 8, and 15 of each cycle. The exact doses of both drugs will be dependent on which cohort the subject is in and adverse events observed in previous cohorts."
16186558|NCT01497613|Behavioral|PRISM C: Computer Condition|A specialized computer system designed to support social connectivity and access to resources; knowledge and prospective memory
16186559|NCT01497613|Behavioral|PRISM B: Notebook Condition|Telephone check-in calls and a notebook that contains information about community resources, games; topics of interests to seniors; a calendar and contact list.
16186560|NCT01497600|Drug|insulin detemir|Each subject will be randomly allocated to three doses: 0.3, 0.6, and 1.2 U/kg. Administrated subcutaneously (s.c., under the skin)
16186561|NCT01497600|Drug|insulin NPH|Each subject will be randomly allocated to three doses: 0.3, 0.6, and 1.2 U/kg. Administrated subcutaneously (s.c., under the skin)
16186562|NCT01497587|Drug|insulin detemir|Single dose, 0.5 U/kg, administered s.c. (under the skin)
16186563|NCT01497574|Drug|insulin detemir|On two dosing visits, 0.4 U/kg insulin detemir will be administered followed by 0.4 U/kg insulin glargine after a 24 hours' interval and repeated in opposite order at next dosing visit. Administrated subcutaneously (s.c., under the skin)
16186564|NCT01497574|Drug|insulin glargine|On two dosing visits, 0.4 U/kg insulin glargine will be administered followed by 0.4 U/kg insulin detemir after a 24 hours' interval and repeated in opposite order at next dosing visit. Administrated subcutaneously (s.c., under the skin)
16186565|NCT01497561|Drug|insulin detemir|Each subject will be randomly allocated to two dose administrations out of four possible doses. Administrated subcutaneously (s.c., under the skin)
16186566|NCT01497561|Drug|insulin NPH|Each subject will be randomly allocated to two dose administrations out of four possible doses. Administrated subcutaneously (s.c., under the skin)
16186567|NCT01497548|Drug|Methylphenidate|Methylphenidate started at 5mg on morning (0800) and noon (1200) on day 1. Dose increased to 10mg on morning (0800) and noon (1200) on day 3; 15mg on morning and noon on day 6 depending on the clinical response. Similarly, the dose can be reduced to 5mg/day if patients are not able to tolerate a higher dose. The treatment continues until day 28.
16186568|NCT01497548|Drug|Placebo|Placebo given on morning (0800) and noon (1200)daily
16186569|NCT01497535|Drug|insulin detemir|On four different dosing days where subjects enter a 24-hour euglycaemic glucose clamp procedure, the subject will be allocated to one single dose of either 0.4 U/kg insulin detemir or 0.4 U/kg insulin glargine administered subcutaneously (s.c., under the skin)
16186570|NCT01497535|Drug|insulin glargine|On four different dosing days where subjects enter a 24-hour euglycaemic glucose clamp procedure, the subject will be allocated to one single dose of either 0.4 U/kg insulin detemir or 0.4 U/kg insulin glargine administered subcutaneously (s.c., under the skin)
16186571|NCT01497522|Drug|Vildagliptin|vildagliptin 50 mg twice daily
16186572|NCT01497522|Drug|Placebo|Matching Placebo of vildagliptin 50 mg twice daily
16186573|NCT01497509|Drug|Bolus 10mL 0.25% bupivacaine/ep 1:600,000; infusion 10mL/hour 0.25% bupivacaine and epi 1:800,000|
16186574|NCT01497509|Drug|Bolus 10mL 0.25% bupivacaine/ epinephrine 1:600,000;infusion 10mL/hour 0.25% bupivacaine, 2 mcg/mL fentanyl, and epinephrine 1:800,000|
16186575|NCT01497509|Drug|Bolus 10mL 0.25% bupivacaine, 10mcg/mL fentanyl, and epi 1:600,000; infusion 10mL/hour 0.25% bupivacaine, 2.5 mcg/mL fentanyl, and epi 1:800,000|
16186576|NCT01497509|Drug|Bolus 10mL 0.25% bupivacaine, 5 mcg/mL fentanyl, and epi 1:600,000; infusion 10mL/hour 0.25% bupivacaine, 3.5 mcg/mL fentanyl, and epi 1:800,000|
16186577|NCT01497509|Drug|No epidural fentanyl or bupivacaine|
16186578|NCT01497496|Drug|High Dose Methylprednisolone (HDMP)|1000 mg/m^2 on Cycle 1: Day 1, 8, 15, 22; Cycle 2: Day 1, 15; Cycle 3: Day 1, 15
16186579|NCT01497496|Drug|Ofatumumab|Ofatumumab infusion will be administered immediately after HDMP. 300 mg on Cycle 1 Day 1. 2000 mg on Cycle 1: Day 8, 15, 22; Cycle 2: Day 1, 15; Cycle 3: Day 1, 15; Cycle 6: Day 1; Cycle 8: Day 1; Cycle 10: Day 1: Cycle 12: Day 1
16186580|NCT01497496|Drug|Lenalidomide|The lenalidomide treatment will start with cycle 4. 5-10 mg pd Days 1-28 as per Creatinine Clearance (CrCl)
16186581|NCT01497483|Drug|Pravastatin alone|Pravastatin 40 mg with placebo.
16186582|NCT01497483|Drug|Pravastatin and Cyclosporine|Pravastatin 40 mg co-administered with 200 mg of cyclosporine.
16186583|NCT01497470|Drug|Custirsen, paclitaxel and carboplatin|Custirsen (640 mg IV over 2 hours) will be administered weekly on Days 1, 8, and 15 of each 21 day cycle. Paclitaxel (200 mg/m2 IV over 3 hours) and carboplatin (AUC 6.0 mg/mL/min IV over 30 minutes) will be administered on Day 1 of each 21 day cycle
16186584|NCT01497457|Procedure|MR saline peritoneography|Ultrasound-guided Intraperitoneal injection of 250cc of steril saline solution with a 22G needle, followed by rectal MR imaging
16186585|NCT01497444|Drug|hypoxia-activated prodrug TH-302|
16186586|NCT01497444|Drug|sorafenib tosylate|
16186587|NCT01497431|Dietary Supplement|Selenium|Given PO
16186588|NCT01497431|Other|Placebo|Given PO
16186589|NCT01497431|Other|Laboratory Biomarker Analysis|Correlative studies
16186590|NCT01497431|Other|Pharmacological Study|Correlative studies
16186591|NCT01497431|Drug|Methylselenocysteine|Given PO
16186592|NCT01497405|Behavioral|Test, Treat, Retain(TTR) + Women's Health CoOp (WHC)|TTR +WHC: Participants in this group will be screened for HIV. HIV positive women, will be given post-test counseling and referrals for prompt medical evaluation and assessment.Both HIV negative and positive participants in this group will participate in 2 individual behavioral counseling sessions focusing on reducing HIV risk behaviours, alcohol and other drug use, and risk of violent victimization. It also adds case management to increase follow through with referrals and risk reduction plans and activities.This will also include case management sessions. This intervention is an adaptation of the evidence-based Women's CoOp (PI: Dr. Wendee M. Wechsberg).
16186593|NCT01497405|Biological|Test, Treat, Retain(TTR) only|TTR +only: Participants in this group will be screened for HIV. HIV positive women will be given post-test counseling and referrals for prompt medical evaluation.
16186594|NCT01497392|Drug|dovitinib lactate|Given PO
16186595|NCT01497392|Drug|gemcitabine hydrochloride|Given IV
16186596|NCT01497392|Drug|capecitabine|Given PO
16186597|NCT01497392|Other|laboratory biomarker analysis|Correlative studies
16186598|NCT01497392|Other|enzyme-linked immunosorbent assay|Correlative studies
16186599|NCT01497392|Other|pharmacological study|Correlative studies
16186600|NCT01497379|Procedure|surgical implantation of subretinal device|surgical implantation of subretinal device
16186601|NCT01497379|Procedure|surgical implantation of subretinal device|intra-individual implant OFF
16186602|NCT01497366|Drug|Sofosbuvir|Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
16186603|NCT01497366|Drug|PEG|Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
16186604|NCT01497366|Drug|RBV|"Ribavirin (RBV) administered as 200 mg tablets up to 1200 mg in a divided daily dose
~Dose of sofosbuvir+RBV group based on baseline weight: < 75kg = 1000 mg and ≥ 75 kg = 1200 mg
~Dose of PEG+RBV group: 800 mg"
16186605|NCT01497353|Procedure|Position at introitus level|After birth: Weigh at 10 + 2 sec then Held the baby at the level of introitus and Cord clamping will be performed at 120 sec then another Weigh will be obtained after clamping
16186606|NCT01497353|Procedure|position at Maternal Abdomen|After birth: Weight at 10 + 2 sec then the baby will be placed at maternal abdomen and Cord clamping will be performed at 120 sec and new Weigh will be obtained after clamping
16186607|NCT01497340|Other|Position at introitus level|After birth: Weight at 10 + 2 sec then Held the baby at the level of introitus and Cord clamping will be performed at 120 sec Weight after clamping
16186608|NCT01497340|Other|Position at Maternal Abdomen|Newborns weight's difference between having them weighed immediately after birth and when cord is clamped in both positions(introitus and abdomen).
16186609|NCT01497327|Drug|PSI-352938|PSI-352938 300mg once daily (QD) for seven days
16186610|NCT01497327|Drug|PSI-7977|PSI-7977 400mg QD for seven days
16186611|NCT01497314|Other|Low Lactose Infant Formula|Low Lactose Infant Formula
16186612|NCT01497301|Behavioral|Group Visits|"During group visits, there will be discussions regarding the basic pathophysiology of diabetes, the ABCs to Better Diabetic Care as defined by the ACP Diabetes Care Guide, setting goals, nutrition, exercise, diabetic medications, and complications of diabetes. Patients will have blood drawn to measure hemoglobin A1C and lipids. They will be educated on self glucose monitoring so they will undergo finger sticks to measure their own glucose. BP measurements, monofilament foot exams, and urine collection for microalbumin will also occur during the study. They may also receive immunizations. A consent form for participation in the group visits, including undergoing the above procedures will be reviewed at our first group visit and signed by all participants."
16186613|NCT01497288|Drug|INFS (Intranasal Fentanyl Spray)|Intranasal Fentanyl Spray
16186614|NCT01497275|Drug|Rituximab, Bortezomib,Y90 ibritumomab tiuxetan|Rituximab 250mg/m2 will be given on day 1 and on day 8. Bortezomib 1.5mg/m2 will be given on Days 1, 4, 8, and 11. Y90 ibritumomab tiuxetan will be given on Day 8. Dosage will be based on the platelet count obtained at the time of study enrollment. The dose will be 0.4mCi/kg unless the enrollee's platelets are between 100,000 and 150,000 in which case a dose of 0.3mCi/Kg will be used. Patients who weigh over 80 Kg will receive a maximum dose of 32mCi.
16186615|NCT01497262|Drug|Fingolimod|Fingolimod will be supplied as 0.5mg capsules in bottles of 35.
16186616|NCT01497249|Dietary Supplement|A dietary fiber (FCHO)|15 g twice per day in beverage
16186617|NCT01497249|Dietary Supplement|Placebo|Placebo drink
16186618|NCT01497236|Dietary Supplement|Dietary Supplement: Nutrition supplement with RUTF or MNP|"14 days nutritional supplementation with either
~a fortified high quality food(RUTF), 1 sachet/day, 500 kcal and multi micronutrients
~a multi micronutrient powder (MNP), 2 sachets per day, no calories, twice recommended daily intake
~a placebo (to MNP), 2 sachets per day , no calories, no micronutrients, containing micronutrient carrier"
16186619|NCT01497223|Drug|MGCD290|1 Oral Dose Administration
16186620|NCT01497210|Device|EASH dressing|Apply study dressing for 4 weeks changing at least every 7 days followed by Aquacel for four weeks.
16186621|NCT01497197|Drug|GONAL-f®|GONAL f® 300 international units [IU] per day as subcutaneous injection using liquid pen.
16186622|NCT01497197|Drug|Luveris®|Luveris® 150 IU per day lyophilized powder for subcutaneous injection.
16186623|NCT01497197|Biological|Recombinant human chorionic gonadotropin (r-hCG)|A single injection of r-hCG (Ovidrel®/Ovitrelle®) 250 mcg to induce final oocyte maturation.
16186624|NCT01497184|Procedure|HSCT|Hematopoietic stem-cell transplant using cells from a matched family donor (matched related allogeneic HSCT) using a non-T cell depleted graft under standard of care procedures
16186625|NCT01497184|Genetic|DLI|Allogeneic donor lymphocyte infusion (DLI) starting dose not to exceed 10^6/m^2 intravenously between 6 weeks and 12 weeks following allogeneic HSCT.
16186626|NCT01497171|Procedure|Elevate Mesh|Transvaginal mesh repair of anterior vaginal prolapse
16186627|NCT01497171|Procedure|Anterior Colporrhaphy|Traditional suture repair of anterior vaginal prolapse
16186628|NCT01497158|Other|Self-help brochure|Self help brochure given at baseline visit.
16186629|NCT01497158|Other|Biomarker feedback|Biomarker feedback from urine of adult non-smoker in the home.
16186630|NCT01497145|Drug|KRN321|
16186631|NCT01497132|Drug|Vitamin D3|Oral drops 30000 IU weekly
16186632|NCT01497132|Drug|Placebo|Matching placebo
16186633|NCT01497119|Drug|JNJ-39758979, 300 mg|Type=exact number, unit=mg, number=300, form=tablet, route=oral use, once daily for 6 weeks.
16186634|NCT01497119|Drug|JNJ-39758979, 100 mg|Type=exact number, unit=mg, number=100, form=tablet, route=oral use, once daily for 6 weeks.
16186635|NCT01497119|Drug|Placebo|Form=tablet, route=oral use, once daily for 6 weeks.
16186636|NCT01497106|Behavioral|Calorie Restriction|Participants will work with the CRU dietetics staff to plan a diet that will result in their losing 1-2 pounds per week over 16 weeks. They will wear an accelerometer to track there activity during these weeks.
16186637|NCT01497106|Behavioral|Control (normal living)|Participants will continue their normal living for entire time of the study. They will be asked to wear an accelerometer for the next 16 weeks and check in weekly at the CRU to exchange accelerometers.
16186638|NCT01497093|Drug|Pomalidomide|Pomalidomide 1, 2, 3, or 4 mg will be taken orally on Days 1-14 of a 21-day cycle
16186639|NCT01497093|Drug|Bortezomib|Bortezomib 1 or 1.3 mg/m2 will be administered intravenously or subcutaneously on Days 1, 4, 8 and 11 of 21 days for cycles 1 -8 and on days 1, 8 of 21 days for cycle 9 and onward until disease progression
16186640|NCT01497093|Drug|Dexamethasone|Dexamethasone 20 mg/day [≤ 75 years old] or 10 mg/day [> 75 years old] will be taken orally on days 1, 2, 4, 5, 8, 9, 11, 12 of 21 days for cycles 1-8 and on days 1, 2, 8, 9 of 21 days for cycles 9 and onward until disease progression
16186641|NCT01497067|Device|ACRYSOF CACHET Phakic Lens (L-series)|Intraocular lens for the treatment of moderate to high myopia
16186642|NCT01497041|Drug|Docetaxel|Docetaxel (diluted in 250 ml of 5% dextrose solution, over 60 minutes) 35 mg/m2 IV (D1, D8) every 3 weeks
16186643|NCT01497041|Drug|Oxaliplatin|Oxaliplatin (diluted in 500 ml of 5% dextrose solution, over 120 minutes) 60 mg/m2 IV D1 every 3 weeks
16186644|NCT01497028|Procedure|PLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial.|PLAGB will be studied and compared to the standard LAGB procedure through a dual center, prospective clinical trial.
16186645|NCT01497015|Behavioral|memory training|10 1-hour sessions over 6-8 weeks
16186646|NCT01497015|Behavioral|speed of processing training|10 1-hour sessions delivered over 6-8 weeks
16186647|NCT01497015|Behavioral|waitlist control|Breast cancer survivors will receive the speed of processing training compact disc in the mail after study completion.
16186648|NCT01497002|Drug|Cytarabine|Induction chemotherapy (1 or 2 courses): AraC 100 mg/m²/day i.v. 24h-infusion day 1-7 and Daunorubicin 60 mg/m² day 3+4+5. Consolidation chemotherapy (2 courses): AraC 1 g/m² i.v. 3h-infusion a 12h day 1+3+5.
16186732|NCT01496326|Drug|Ibuprofen|10% ibuprofen cream formulation at a dose of 200mg
16186733|NCT01496326|Drug|placebo|2 grams of placebo cream for 14 days
16186772|NCT01495988|Drug|Bevacizumab|Patients assigned to the combination arm will also receive bevacizumab at 15mg/kg, intravenously, every 3 weeks.
16187452|NCT01490866|Drug|5-Fluorouracil|2400 mg/m2 over 46-48 hours Days 1 and 15; Continuous Intravenous
16186649|NCT01497002|Biological|human stem cells|Induction chemotherapy (1 or 2 courses): AraC 1 g/m² i.v. 3h-infusion a 12h day 1+3+5+7, Mitoxantrone 10 mg/m² day 1-3 and Pegfilgrastim 6 mg s.c. day 10. Consolidation chemotherapy (1 course): AraC 500 mg/m² i.v. 1h-infusion a 12h day 1+3+5, Mitoxantrone 10 mg/m² day 1+2 and Pegfilgrastim 6 mg s.c. day 8. Allogeneic stem cell transplantation using reduced intensity conditioning: Fludarabine 30 mg/m² day -4 - -2, TBI 200 cGy day 0; GvHD prophylaxis: cyclosporine A and mofetil mycofenolate
16186650|NCT01496989|Biological|HIV-MAG (3,000mcg)|Delivered intramuscularly by in vivo electroporation
16186651|NCT01496989|Biological|GENEVAX® IL-12 (100mcg)|Co-administered with HIV-MAG, delivered intramuscularly by in vivo electroporation
16186652|NCT01496989|Biological|GENEVAX® IL-12 (1000mcg)|Co-administered with HIV-MAG, delivered intramuscular by in vivo electroporation
16186653|NCT01496989|Biological|Ad35-GRIN/ENV|(2x10^10vp) Delivered intramuscularly by standard needle injection
16186654|NCT01496976|Drug|High Dose Methylprednisolone (HDMP)|HDMP will be administered at 1 gm/m^2 IV over 90 minutes daily with ofatumumab infusions 1-8.
16186655|NCT01496976|Drug|Ofatumumab|Ofatumumab infusion will be administered immediately after HDMP.
16186656|NCT01496976|Drug|Lenalidomide|The Lenalidomide Starting Dose (Cycle 4) Based on Renal Function Prior to Cycle 4 of Treatment.
16186657|NCT01496963|Other|Physician standard-of-care according to ESC/ERS Guidelines|Physician standard-of-care
16186658|NCT01496950|Device|10Hz active rTMS|10Hz active rTMS delivered to the left dorsolateral prefrontal cortex
16186659|NCT01496950|Device|Placebo|10Hz placebo rTMS delivered to the vertex
16186660|NCT01496937|Drug|GLPG0974|
16186661|NCT01496937|Drug|GLPG0974|
16186662|NCT01496924|Other|speech therapy|A single oral-motor technique will be used in a 10-times series intercalated with rest. Swallowing training techniques comprised indirect therapy (swallowing of saliva) and direct therapy (swallowing of food).
16186663|NCT01496911|Drug|Levocetirizine|a single oral dose of 5 mg
16186664|NCT01496911|Drug|Hydroxyzine|a single oral dose of 50 mg
16186665|NCT01496911|Drug|Placebo|a single oral dose
16186666|NCT01496885|Other|Observational study|This was an observational study and no study drug was administered.
16186667|NCT01496859|Device|Placement and use of Baska mask|use of a supraglottic airway device as a standard part of a general anaesthetic
16186668|NCT01496846|Drug|IANB Articaine|IANB anesthesia given with 1.7cc of 4% articaine, 1:100,000 epinephrine.
16186669|NCT01496846|Drug|SUP Articaine|After unsuccessful IANB with articaine, proceed to give 1.7cc of 4% articaine with 1:100,000 epinephrine in buccal mucosa as a supplemental infiltration injection (SUP).
16186670|NCT01496846|Drug|SUP Lidocaine|After unsuccessful IANB with articaine, proceed to give 1.7cc of 2% lidocaine with 1:100,000 epinephrine in buccal mucosa as a supplemental infiltration injection (SUP).
16186671|NCT01496833|Device|Ankura Branched/Fenestrated Stent Graft|Ankura Branched/Fenestrated Stent Graft（Lifetech Scientific Co.,LTD.，Shenzhen, China）
16186672|NCT01496820|Dietary Supplement|GO2KA1|GO2KA1(chitosan oligosaccharide)1500mg/day for 12weeks
16186673|NCT01496820|Dietary Supplement|Placebo|placebo 1500mg/day for 12weeks
16186674|NCT01496807|Drug|Sylatron|Sylatron - Once per week for 12 weeks, given as an injection under the skin.
16186675|NCT01496807|Drug|Yervoy|Yervoy - Once every 3 weeks for 12 weeks (4 times total), given over a 90-minute intravenous infusion (through the vein).
16186676|NCT01496781|Procedure|Hemoclip|Hemoclip application is a standard treatment option after endoscopic mucosal resection of colonic lesion to stop and prevent post-procedure bleeding.
16186677|NCT01496781|Procedure|EndoClot|EndoClot hemostat is applied immediately after EMR to achieve hemostasis.
16186678|NCT01496768|Dietary Supplement|Leucine|7,2 g/day during 3 months
16186679|NCT01496768|Dietary Supplement|Alanine|7,2 g/day during 3 months
16186680|NCT01496755|Drug|Placebo|Single/multiple doses
16186681|NCT01496755|Drug|RG7667|Single/multiple ascending doses
16186682|NCT01496742|Drug|Placebo|Matching RO5490258 (MetMAb) placebo iv, Day 1 of each 21-day cycle
16186683|NCT01496742|Drug|RO5490258|15 mg/kg iv, Day 1 of each 21-day cycle
16186684|NCT01496742|Drug|bevacizumab [Avastin]|15 mg/kg iv, Day 1 of each 21-day cycle
16186685|NCT01496742|Drug|cisplatin/carboplatin|standard dose iv, Day 1 of each 21-day cycle, 4 cycles
16186686|NCT01496742|Drug|paclitaxel|200 mg/m2 iv, Day 1 of each 21-day cycle, 4 cycles
16186687|NCT01496742|Drug|pemetrexed|500 mg/m2, Day 1 of each 21-day cycle
16186688|NCT01496729|Procedure|Transversus abdominis plane (TAP) block|A Transversus abdominis plane (TAP) block with ropivacaine, a local anesthetic, will be performed at the end of the surgical procedure.
16186689|NCT01496729|Procedure|Sham TAP block with normal saline|A sham TAP block with normal saline will be performed at the end of the surgical procedure.
16186690|NCT01496716|Procedure|Hip arthroplasty|The purpose of hip arthroplasties is to reduce pain and increase mobility.
16186691|NCT01496703|Other|no intervention, this is an observational retrospective trial|no intervention, this is an observational retrospective trial
16186692|NCT01496690|Drug|Pregabalin|Subjects are randomized 1:1 to either pregabalin treatment or placebo. The intervention period is 8 weeks. The daily pregabalin dose is 75 mg. during the first week followed by 7 weeks of flexible daily dosing (150, 300, 450 or 600 mg.) depending on tolerability and response. Doses above 150 mg. should be divided in two daily dosages.
16186693|NCT01496690|Drug|Pregabalin Placebo Capsules|Parallel to Active Comparator
16186694|NCT01496677|Drug|TR-701 FA 200 mg|Single oral tablet of TR-701 FA to elderly subjects
16186695|NCT01496677|Drug|TR-701 FA 200 mg|Single oral tablet of TR-701 FA to younger group (18-45 years old)
16186696|NCT01496664|Procedure|Combined CABG and PCI|Coronary artery bypass grafting Percutaneous coronary intervention
16186734|NCT01496313|Drug|300mg vandetanib|"Oral blinded tablets taken once daily.
~At objective disease progression or 14 months (whichever is earlier), patient may be unblinded to treatment
~Dosing with unblinded study treatment can continue until 24 months after patient was randomised.
~At any time dosing may be interrupted for up to 6 weeks due to toxicity. Dosing may restart at a reduced dose (200mg/day). Once reduced, dose increases are not permitted and dosing must stop if further toxicities occur."
16186808|NCT01495728|Procedure|Sham Manipulation|Mid and Upper Thoracic Spine
16186697|NCT01496651|Procedure|Percutaneous coronary intervention|"PCI will be performed by the femoral or the transradial approach. In complex distal lesion anatomies, the use of 7-8F guiding catheters and the transfemoral approach may be recommended. Ostial and mid-shaft lesions will be treated with a single stent. For the treatment of distal bifurcation lesions crush, culotte, T-stenting, V-stenting or a single stent strategy may be used according the lesion morphology and the experience of the operator. However, based on the Nordic Bifurcation Studies the culotte technique seems to be associated with especially favorable angiographic and long-term clinical results in these large vessel size bifurcation lesions.
~There should be a low threshold for the use of high pressure post dilatation balloons. Generally, final kissing balloon dilatations are encouraged and mandatory when two-stent techniques are used. Intravascular ultrasound (IVUS) in mandatory pre and post stent placement."
16186698|NCT01496651|Procedure|Coronary artery bypass graft operation|Patients randomized to the CABG group for the treatment of LMCA stenosis are treated according to current clinical practice. Both off-pump and on-pump techniques can be used and the selection between the used methods is operator dependent. The left internal mammary artery will be used for the revascularization of the left anterior descending coronary artery, whenever feasible. For other lesion location, saphenous venous grafts, free arterial grafts or the right internal mammary artery may be used.
16186699|NCT01496638|Procedure|Implantation of coronary stent in bifurcation lesion|Implantation of coronary stent in bifurcation lesion with no side branch treatment
16186700|NCT01496638|Procedure|Implantation of coronary stent in bifurcation lesion|Implantation of coronary stent in bifurcation lesion with stenting of main vessel and side branch
16186701|NCT01496612|Drug|Buspirone|
16186702|NCT01496612|Drug|Placebo|
16186703|NCT01496573|Other|laboratory biomarker analysis|Correlative studies
16186704|NCT01496547|Drug|intensive chemo - RIC preparation|The intensive chemotherapy is composed of fludarabine 35mg/m2 + high-dose cytarabine 2g/m2 D1-5 + idarubicin (12mg/m2) D5-7. The reduced intensity preparation regimen will start 7 days after the chemotherapy with fludarabine 35mg/m2 for 5 days + iv busulfan 3.2mg/kg/day for 3 days followed by stem cell infusion 2 days later.
16186705|NCT01496534|Drug|Cisplatin|Gemcitabine 1000 mg/m2 IV on days 1 + 8 Cisplatin 70 mg/m2 IV day 1 Dovitinib given orally on days 1-5, 8-12 and 15-19. Treatment will be recycled every 21-days. The dose of dovitinib will be escalated in successive cohorts
16186706|NCT01496534|Drug|Carboplatin|Gemcitabine 1000 mg/m2 IV on days 1 + 8 Carboplatin AUC 5 IV day 1 Dovitinib given orally on days 1-5, 8-12 and 15-19. Treatment will be recycled every 21-days. The dose of dovitinib will be escalated in successive cohorts
16186707|NCT01496521|Drug|Aspirin|100mg qd for 6 months.
16186708|NCT01496521|Dietary Supplement|Tea Polyphenols|300mg bid for 6 months.
16186709|NCT01496508|Device|mechanical ventilation (SLE 5000, Servo-i-Maquet)|Ventilation strategies for both groups were to emphasize lung recruitment and avoid atelectasis and over distention. The optimum lung volume was determined as expansion to 8 to 9.5 ribs for most infants, and 7 to 8 ribs for infants with air leak. HFOV setting were as follows: initial frequency was set between 11 and 15Hz; pressure amplitude of oscillation was initially adjusted to provide adequate chest wall movement and was subsequently titrated to maintain the PaCO2 between 40 and 55 mmHg; The initial mean airway pressure (MAP) was set at 8-10 cmH2O. MAP and FIO2 were set to maintain arterial oxygen saturation between 88 to 95%, an arterial pH of at least 7.25. Extubation was considered when MAP was ≤7 cmH2O and the pressure amplitude of oscillation reach 10 to 15 cmH2O.
16186710|NCT01496495|Drug|ARRY-614, p38/Tie2 inhibitor; oral|Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule
16186711|NCT01496482|Other|Only measurements done on subjects in both groups.|As study compared specific diagnostic procedures, no intervention was done or compared.
16186712|NCT01496469|Drug|Febuxostat|Febuxostat 80 mg, tablets, orally, once daily for up to 6 weeks
16186713|NCT01496469|Drug|Placebo|Febuxostat placebo-matching tablets, orally, once daily for up to 6 weeks.
16186714|NCT01496456|Device|Resin infiltration|Split-mouth design (at least two lesions per patient): Treatment of one caries lesion with resin infiltration therapy
16186715|NCT01496456|Behavioral|Caries management|Split-mouth design (at least two lesions per patient). Baseline preventative caries management: dietary and behavioral modification, and over-the-counter fluoride supplements
16186716|NCT01496443|Drug|TAK-875 and Glimepiride|
16186717|NCT01496430|Drug|Placebo|
16186718|NCT01496430|Drug|Azilsartan medoxomil|
16186719|NCT01496430|Drug|Azilsartan medoxomil|
16186720|NCT01496417|Drug|Belatacept|Belatacept infusion intravenous at 10 mg/kg on post-operative days 1, 5, and weeks 2, 4, 8, 12; 5mg/kg intravenous dose at weeks 16, 20, 24, 28, 32, 36, 40, 44, and 48.
16186721|NCT01496404|Procedure|Electrocautery|Electrocautery using cutting mode of epidermis and dermis of skin.
16186722|NCT01496404|Procedure|Scalpel|Incising skin (epidermis and dermis) with scalpel.
16186723|NCT01496378|Behavioral|Problem-Solving Skills Training|Parents will receive 8, 1-hour sessions of individual problem-solving therapy over 8 weeks. Caregivers will complete the first training session and at least 3 subsequent sessions in person. Remaining sessions will be completed via telephone. In session 1, parents will be introduced to the PSST program and a rationale and explanation for problem solving strategies will be provided. During sessions 2-8, parents will identify a problem that they wish to work on. The therapist will use the primary cognitive-behavioral strategies of modeling, behavioral rehearsal, performance feedback, and generalization of skills in the process of teaching problem solving skills to parents. Parents will complete homework assignments to practice using the problem-solving skills in real-life situations
16186724|NCT01496365|Drug|DS-5565 tablet|5mg and 10mg tablets
16186725|NCT01496365|Drug|pregabalin capsule|75mg and 150mg over-encapsulated
16186726|NCT01496365|Drug|Placebo tablet|
16186727|NCT01496365|Drug|placebo capsule|
16186728|NCT01496352|Drug|DFA-02|Modified release product containing gentamicin and vancomycin for application at the conclusion of surgery after closure of the fascia and prior to skin closure
16186729|NCT01496352|Drug|Placebo|DFA-02 placebo
16186730|NCT01496339|Biological|MenSCs transplantation|1×10^6/kg MenSCs are infused through pancreatic artery or intravenous infusion once a week by the 4 consecutive therapies.
16186731|NCT01496339|Drug|exogenous indulin injection daily|traditional therapy, such as insulin injection daily, monitoring random and postprandial blood glucose.
16186735|NCT01496313|Drug|150mg vandetanib|"Oral blinded tablets taken once daily.
~At objective disease progression or 14 months (whichever is earlier), patient may be unblinded to treatment. Patients who have not dose reduced at the time of unblinding may have their dose increased to 300mg
~Dosing with unblinded study treatment can continue until 24 months after patient was randomised
~At any time dosing may be interrupted for up to 6 weeks due to toxicity. Dosing may restart at a reduced dose (100mg/day) [OR 300 reduced to 200mg/day if dose was increased at unblinding.] Once reduced, dose increases are not permitted and dosing must stop if further toxicities occur."
16186736|NCT01496300|Procedure|Manual Intervention|Implantation of acetabular component without the use of the navigation system information
16186737|NCT01496300|Procedure|Navigated Intervention|Navigated implantation of acetabular component using OrthoPilot image free navigation system
16186738|NCT01496287|Device|Tube Delivery System (TDS)|Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting
16186739|NCT01496274|Biological|rIX-FP|Recombinant IX-FP (rIX-FP) is a fusion protein linking coagulation factor IX with albumin, and will be administered by intravenous administration
16186740|NCT01496261|Drug|Clopidogrel and Aspirin|Clopidogrel and Aspirin seperate combination, single dose
16186741|NCT01496261|Drug|Fixed dose combination of clopidogrel/aspirin|Fixed dose combination of clopidogrel/aspirin
16186742|NCT01496248|Dietary Supplement|Korean Red Ginseng|100% of the past psychiatric medication dose will be maintained during 8 week study period. Korean Red ginseng will be started with 2g/day and then maintained using flexible dosing of 2-3g/day during the study period.
16186743|NCT01496235|Dietary Supplement|Dark chocolate|Each chocolate bar provided 210 calories represented in 25 grams of carbohydrates, 3 g of proteins, 18 g of total fat and the presence of 70% cocoa solids
16186744|NCT01496235|Dietary Supplement|White chocolate|Each chocolate bar provided 230 calories represented in 28 grams of carbohydrates, 3 g of proteins, 18 g of total fat, without the presence of 70% cocoa solids
16186745|NCT01496209|Biological|Endomyocardial injections of allogeneic Human CSps|NOGA electromechanical mapping and endomyocardial injections at 15 peri-infarct sites, via NOGA MYOSTAR catheter, of Allogeneic Human CSps.
16186746|NCT01496209|Biological|Endomyocardial injections of vehicle only.|NOGA electromechanical mapping and endomyocardial injections at 15 peri-infarct sites, via NOGA MYOSTAR catheter, of placebo.
16186747|NCT01496196|Drug|tranexamic acid|500 mg/5 ml 3-4 times a day
16186748|NCT01496196|Drug|tranexamic acid|500 mg/5 ml 3-4 times a day
16186749|NCT01496183|Drug|Olanzapine|Olanzapine 5mg capsule administered orally at bedtime for 7 days followed by Olanzapine 10 mg capsule administered orally at bedtime for 7 days.
16186750|NCT01496183|Drug|Placebo|Placebo capsule administered orally at bedtime for 14 days
16186751|NCT01496170|Drug|MK-8931|MK-8931, capsules, at a dose of 12 or 40 mg, orally, once per day for 7 days
16186752|NCT01496170|Drug|Placebo|Placebo capsules, orally, once per day for 7 days
16186753|NCT01496157|Drug|18F-DCFBC|A bolus of 10 mCi (370 MBq) [9-11 mCi (333-407 MBq)] of 18F-DCFBC will be injected into the IV line by slow IV push.
16186754|NCT01496144|Procedure|Manual therapy and active exercises|"Spinal manipulation/mobilisation (5-10 minutes), consisting of passive accessory intervertebral movements, muscle-energy techniques and high velocity, low amplitude dynamic thrust.
~Active exercises (20 minutes), consisting of mobility, stretching, strengthening and motor control exercises"
16186755|NCT01496144|Procedure|Detuned ultrasound and active exercises|Electrotherapy device inactivated and ineffective. Active exercises, consisting of mobility, stretching, strengthening and motor control exercises
16186756|NCT01496131|Radiation|Radiation therapy|Radiation therapy will be administered at a daily dose of 180 centigrays (cGy) 5 days a week for approximately 6 to 8 weeks.
16186757|NCT01496131|Drug|Goserelin|ADT (Goserelin) will be administered at a dose of 10.8 milligrams (mg) subcutaneously every 3 months for 24 months for the high risk group and for 6 months in the intermediate risk group, starting 2-3 months prior to radiation therapy.
16186758|NCT01496131|Drug|Cyclophosphamide|Cyclophosphamide will be administered at a single dose of 300 milligrams per square meter (mg/m^2) to a maximum of 600 mg, as an intravenous injection 3 days prior to the first administration of tecemotide (L-BLP25).
16186759|NCT01496131|Drug|Tecemotide (L-BLP25)|Tecemotide (L-BLP25) will be administered at a dose of 918 microgram (mcg) as subcutaneous injection every 2 weeks for 5 doses followed by every 6 weeks for an additional 4 doses, starting 2-3 months prior to radiation therapy and on the same day that ADT began.
16186760|NCT01496118|Drug|carfilzomib and panobinostat|"Cohort 1 (Dose Level 4): Carfilzomib Cycle 1: 20 mg/m2 IV D1, 2 / 45 mg/m2 IV D8, 9, 15, 16; Carfilzomib Cycle 2 to progression: 45 mg/m2 IV D 1, 2, 8, 9, 15, 16;
~Panobinostat cycle 1: 30 mg D 1, 3, 5, 15, 17, 19; Panobinostat cycle 2 to progression: 30 mg D 1, 3, 5, 15, 17, 19
~Cohort 2 (Dose Level 6): Carfilzomib Cycle 1: 20 mg/m2 IV D1, 2 / 56 mg/m2 IV D8, 9, 15, 16; Carfilzomib Cycle 2: 56 mg/m2 IV D 1, 2, 8, 9, 15, 16;
~Panobinostat all cycles: 20 mg D 1, 3, 5, 15, 17, 19."
16186761|NCT01496105|Drug|Lidocaine|
16186762|NCT01496105|Drug|saline|
16186763|NCT01496092|Drug|Keto Acid|12 tablets per day
16186764|NCT01496066|Device|LAL (Light Adjustable Lens) and Light Deliver Device (LDD)|LAL implanted and adjusted with LDD
16186765|NCT01496066|Device|Monofocal control IOL|Commercially available monofocal intraocular lens (IOL)
16186766|NCT01496053|Dietary Supplement|AndoSan|AndoSan 30 ml x 2 for 21 days
16186767|NCT01496053|Dietary Supplement|Sugar Extract|Sham comparator
16186768|NCT01496040|Drug|rAAV2/4.hRPE65|"One injection in on eye
~Cohorte 1 : 3 patients will receive one injection of up to 400 microliters of the IMP
~Cohorte 2 : 3 patients will receive one injection of up to 800 microliters of the IMP.
~Cohorte 3 : 3 patients under age of eighteen will receive one injection up to 400 or 800 microliters of the IMP."
16186769|NCT01496001|Procedure|Lumpectomy, axillary block dissection, breast conserving surgery|Wide excision of primary tumor (using 1 cm surgical margins). Minimally invasive biopsy of the sentinel lymph node.
16186770|NCT01496001|Other|Radiotherapy|Adjuvant radiotherapy carried out by institutional protocols.
16186771|NCT01495988|Drug|Vemurafenib|Vemurafenib will be given at a dose of 960 mg, orally, 2X a day to all patients until disease progression, intolerable toxicity, patient request for discontinuation, or study termination by the sponsor.
16186809|NCT01495715|Drug|Idebenone|
16186773|NCT01495988|Drug|Cobimetinib|Cobimetinib will be given at a dose of 60mg, orally, 1X a day to all patients for 21 days, then 7 days off, in a 28 day treatment cycle.
16186774|NCT01495975|Other|Diabetes Transitions Tool Kit|Access to a remote glucose monitoring and a web-based patient-provider communication portal, the Diabetes Transitions Toolkit (DTTK), for the month after discharge.
16186775|NCT01495962|Drug|Botulinum Toxin Type A|Six 25 cc injection of Botulinum Toxin A
16186776|NCT01495962|Drug|Placebo|Placebo (Normal Saline)
16186777|NCT01495949|Drug|etomidate|During induction, after 3 mcg/kg of fentanyl and 0.05 mg/kg of midazolam given, small doses 2-4 mg (1-2 ml) of etomidate will be given by titration (the syringe pump and extension and three way stopcock are covered to blind the study drug) until the patients are unconscious.
16186778|NCT01495949|Drug|thiopentone|During induction, after 3 mcg/kg of fentanyl and 0.05 mg/kg of midazolam given, small doses 25-50 mg (1-2 ml) of thiopentone will be given by titration (the syringe pump and extension and three way stopcock are covered to blind the study drug) until the patients are unconscious
16186779|NCT01495936|Procedure|RM + Positive End Expiratory Pressure|A recruitment maneuver (RM) will be applied to the ventilated lung by performing a valsalva maneuver for 5 seconds (holding the inspiratory pressure at 25cmH2O). Immediately after the RM, Positive End Expiratory Pressure (PEEP) will be applied to the ventilated lung at a pressure of 5cmH2O for 20 minutes. Both the RM and PEEP will be performed using the operating room ventilator.
16186780|NCT01495936|Procedure|Continuous Positive Airway Pressure|Continuous positive airway pressure, at a pressure of 5cmH2O will applied to the non-ventilated lung for 20 minutes by the Mallinckrodt Bronchocath Disposable CPAP system (a recognised anesthetic breathing system design for CPAP)
16186781|NCT01495923|Procedure|epidural steroid injection|Injection of steroids and local anesthetic into the epidural space
16186782|NCT01495923|Procedure|Sham epidural steroid injection|Injection of saline into the back muscles
16186783|NCT01495923|Drug|Gabapentin|Titration of gabapentin to effect
16186784|NCT01495923|Drug|Placebo gabapentin|Titration of placebo gabapentin
16186785|NCT01495910|Drug|Abiraterone acetate|Abiraterone acetate oral suspension administered daily from study Day 1 to study Day 6 of each treatment period: the first dose level is 100 mg with escalating doses of 250 mg and 500 mg in subsequent treatment periods.
16186786|NCT01495897|Device|Tracking eye movement|Device: studying Saccadic eye movements with a video eye tracker: The subjects are seated in darkness facing a screen located 60 cm before their eyes, their chin on a chin strap and their forehead placed against a frontal support. Eye position is sampled at 500 Hz with a video-based monocular eye tracker (SMI, Germany). Each recording session start with a calibration test in which the subjects looked at nine consecutive targets covering the entire visual field, as used during the oculomotor paradigms: four experimental conditions: a visually guided saccade task, a pre-test, a backward adaptation task, and a post-test. The pre-test and post-test (40 trials each) are performed before and immediately after the backward adaptation task, in the same conditions, except that the target was extinguished when the velocity threshold (150°/s for 10 ms) is reached, instead of jumping to a new location.
16186787|NCT01495897|Device|Tracking eye movement under deep brain stimulation|Device: studying Saccadic eye movements with a video eye tracker. If the patient has deep brain stimulation, recording will be made in the morning, before the usual morning start of the deep brain stimulation.
16186788|NCT01495884|Drug|non-pegylated liposomal doxorubicon (Myocet™)|
16186789|NCT01495884|Drug|Lapatinib (Tyverb™)|
16186790|NCT01495871|Dietary Supplement|Amino Acids|15 grams amino acids two times per day for 6 weeks
16186791|NCT01495871|Dietary Supplement|Placebo of inert compounds|Placebo two times per day for 6 weeks
16186792|NCT01495871|Dietary Supplement|Valine|2.5 grams valine supplementation two times a day for 6 weeks
16186793|NCT01495858|Drug|Naproxen Sodium 440 mg / DPH 25 mg (BAY98-7111)|Participants received one tablet of Naproxen Sodium 220 mg / Diphenhydramine hydrochloride (DPH) 25 mg and one tablet of Naproxen Sodium 220 mg, single dose, orally.
16186794|NCT01495858|Drug|Naproxen Sodium 440 mg (BAYH6689)|Participants received two tablets of Naproxen Sodium 220 mg, single dose, orally.
16186795|NCT01495858|Drug|DPH 50 mg|Participants received two tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
16186796|NCT01495845|Other|Pharmacogenomics testing for clopidogrel responsiveness|Patients must come to the pharmacy for all visits. At the 1st visit, the patient will provide consent, a complete list of medications, a complete pre-study questionnaire, a copy of their insurance card, and a buccal swab (collected by the pharmacist). The swab will be sent to the testing facility for genotypic testing of CYP2C19. Upon receipt of the results of the results, the pharmacist will propose an intervention to the prescriber based on the patient's indication for clopidogrel and the identification of certain genetic variations atCYP2C19. All patients will be asked to return to the pharmacy for explanation of the results and implementation of any changes approved by the prescriber and to complete a follow-up questionnaire. After the visit to explain the results of testing, the patient's insurance will be billed electronically for a medication therapy management visit; patients without insurance will not be billed. Patients may opt out of billing to insurance at any time.
16186797|NCT01495832|Other|Pulse Group|The pulse group will consume pulse-enriched foods designed to deliver ½ cup of pulses per day for 12 weeks.
16186798|NCT01495832|Other|Control Group|The control group will consume comparator foods for 12 weeks.
16186799|NCT01495819|Drug|Saline|5cc's of saline give at least once.
16186800|NCT01495819|Drug|Nicotine|(0.0125, 0.025, 0.0.5, 0.1 and 0.2 mg/70 kg or about 0.18, 0.36, 0.7, 1.4 and 2.8 µg/kg).
16186801|NCT01495806|Drug|Glucomannan|2 x 5g
16186802|NCT01495806|Drug|placebo|glucose 5 g
16186803|NCT01495793|Drug|Rotigotine|"Rotigotine transdermal patch:
~Dose (size): 0.5 mg/24 h (2.5 cm^2)- 1 mg/24 h (5 cm^2)- 2 mg/24 h (10 cm^2)- 3 mg/24 h (15 cm^2) The patch has to be applied continuously for 24h. After 24h, the patch has to be removed and a new one applied."
16186804|NCT01495780|Behavioral|Remote Health Monitoring|1 year of remote health monitoring of symptoms, medication use, breathing tests, physical activity, and healthcare utilization.
16186805|NCT01495767|Other|Filling in a psychometric questionnaire|Juvenile patients attending the uveitis are asked to fill in a psychometric questionnaire
16186806|NCT01495754|Other|coffee|Comparison of different amounts of coffee
16186807|NCT01495728|Procedure|Thrust Manipulation - Thoracic Spine|Mid and Upper Thoracic Spine
16186811|NCT01495702|Drug|NNRTI|NNRTI agents administered according to prescribing information; allowed NNRTIs include efavirenz (EFV), nevirapine, or rilpivirine.
16186812|NCT01495702|Drug|FTC/TDF|FTC/TDF (200/300 mg) administered according to prescribing information
16186813|NCT01495702|Drug|Stribild|Stribild® (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate; E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food
16186814|NCT01495689|Behavioral|Ottawa Model with SmartCard|On-site counseling for Smoking Cessation along with the IVR automated telephone call follow-up and SmartCard worth $110 towards purchase of smoking cessation aids
16186815|NCT01495689|Behavioral|Usual care|Usual care or control arm will receive strong physician advice, brief counseling from clinic nurse +/- a prescription for smoking cessation aid if requested and willing
16186816|NCT01495676|Other|Radiation + cisplatin|"RT will encompass bilateral internal and external iliac lymph nodes at a dose of 45 Gy and the bladder up to 63 Gy. Fractionation will be 1.8 Gy per fraction.
~Cisplatin: 20 mg/m2/day through continuous iv perfusion for 4 consecutive days, from D2 to D5 and from D23 to D26 for the first part of the treatment, then from D2 to D5 if an additional treatment is decided.
~A cystoscopy with a transurethral resection will be performed 3 weeks after the last day of the first part of radio-chemotherapy.
~In the absence of tumor cells, the 2nd part will start on the 4th week or at latest on the 5th week after the last day of the 1st part of radio-chemotherapy.
~In case of a microscopic tumor residue or of a local tumor progression, operability will be re-evaluated in view of a radical cystectomy and the patient will exit the study."
16186817|NCT01495676|Other|Radiation + cisplatin + gemcitabine|"Radiotherapy will encompass bilateral internal and external iliac lymph nodes at a dose of 45 Gy and the bladder up to 63 Gy. Fractionation will be 1.8 Gy per fraction.
~Cisplatin: 20 mg/m2/day through continuous iv perfusion for 4 consecutive days, from D2 to D5 and from D23 to D26 for the first part of the treatment, then from D2 to D5 for the second part of the treatment if an additional treatment is decided.
~Gemcitabine: iv injection for 30 minutes, twice a week at a dose of 25 mg/m2 on days 2, 5, 9, 12, 16, 19, 23, 26, 30, and 33 for the 1st part of treatment, then on days 2, 5, 9, and 12 for the 2nd part of treatment if an additional treatment is decided (cystoscopy with a transurethral resection). RT will be delivered between 2 and 6 hours after completion of the gemcitabine injection."
16186818|NCT01495663|Drug|I-131-CLR1404|"Description:
~Dosimetry: IV, 5 mCi, single dose, 6-day duration
~Therapy: IV, starting dose level of 12.5 mCi/m2, single dose, 56-day duration with follow up to one year"
16186819|NCT01495650|Behavioral|Tailored program of PA and nutritional counseling|Patients receive tailored program of physical exercises and nutritional counseling during the course of adjuvant treatments (CT followed by RT, 27 weeks).
16186820|NCT01495637|Drug|GM-CSF|GM-CSF is to be administered IV at one of four possible dosing regimens (three days at a dose of 30, 62, or 125 mcg/m2 per day, or an extended dosing regimen of 125 mcg/m2/day through post-trauma 6) if severe innate immune suppression is identified on post-trauma days 1, 2, or 3.
16186821|NCT01495624|Other|ropivacaine plus dexamethasone anesthetic|Subjects will receive interscalen block comprised of 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic with 2 ml normal saline given intravenously (systemic placebo);
16186822|NCT01495624|Other|ropivacaine plus saline plus dexamethasone anesthetic|Subjects will receive interscalen block with 30 ml 0.5% ropivacaine for interscalene block mixed with 2 ml normal saline (perineural placebo) plus dexamethasone 8 mg (2 ml) administered systemically.
16186823|NCT01495598|Drug|Pomalidomide|5 mg p.o. for 21 of 28 days
16186824|NCT01495585|Drug|Lonafarnib|Commercially approved products used to test the research hypothesis
16186825|NCT01495585|Other|Placebo|Placebo control
16186826|NCT01495572|Drug|Fludarabine|25 mg/m^2 IV (in the vein) for 5 days (day -5 to -1)
16186827|NCT01495572|Drug|Cyclophosphamide|60 mg/kg IV (in the vein) for days -7 and -6
16186828|NCT01495572|Drug|Aldesleukin|Only given to patients assigned to high dose (HD) Arm - 720,000 IU/kg intravenous (IV) over 15 minutes, every 8 hrs (+/- 1 hr) for up to 5 days (max 15 doses).-6
16186829|NCT01495572|Drug|MART-1 Reactive CD8+ PBL|Intravenous (IV) over 30 minutes on day 0
16186830|NCT01495546|Other|Early loading|Patients stepping down immediately after THA
16186831|NCT01495546|Other|Late loading|Patients stepping down after three weeks of HTA
16186832|NCT01495533|Device|uncoated AngioSculpt(R)|Predilatation of coronary BMS-ISR with POBA followed by a AngioSculpt(R) scoring balloon (no drug coating)
16186833|NCT01495533|Device|Drug coated AngioSculpt(R)|Predilatation of coronary BMS-ISR with POBA followed by a drug coated AngioSculpt(R) scoring balloon (paclitaxel 3.0 µg/mm²)
16186834|NCT01495520|Drug|Ranolazine|os, pill, 750 mg, b.i.d., 30 days
16186835|NCT01495520|Drug|Placebo|os, pill, b.i.d., 30 days
16186836|NCT01495507|Procedure|MPFL- Reconstruction|
16186837|NCT01495494|Device|Marketed Nasal Strip|Breathe Right Nasal Strips - Clear small/medium strip
16186838|NCT01495494|Device|Prototype Nasal Dilator|Prototype Nasal Dilator AB2R11
16186839|NCT01495481|Drug|Dexmedetomidine|Dexmedetomidine 2 mcg/kg, Intravenous push
16186840|NCT01495481|Drug|Adenosine|Stepwise incremental approach of adenosine starting at 0.2 mg/kg (max 6 mg) followed by 0.3 mg/kg (max 12 mg) if initial dose was unsuccessful
16186841|NCT01495468|Biological|PEG-somatropin|drug:pegylated somatropin 0.2mg/(kg.w), once per week for 6 months drug: Jintropin AQ, 0.25mg/(kg.w), once per day for 6 months
16186842|NCT01495442|Device|modified Handihaler DPI|subjects randomized to receive 1 inhaled dose on 2 separate days, each dose delivered 2-3 days apart. The radiolabeled albuterol drug powder will be dispersed from either the DET bead-HandiHaler prototype or via the established HandiHaler device standard with the lactose-albuterol formulation provided to us by the sponsor.
16186843|NCT01495442|Device|standard Handihaler DPI|subjects randomized to receive 1 inhaled dose on 2 separate days, each dose delivered 2-3 days apart. The radiolabeled albuterol drug powder will be dispersed from either the DET bead-HandiHaler prototype or via the established HandiHaler device standard with the lactose-albuterol formulation provided to us by the sponsor.
16186844|NCT01495429|Procedure|Central venous catheter|Placement of a peripherally inserted central venous catheter
16186845|NCT01495429|Procedure|Central venous catheter|Placement of a centrally inserted central venous catheter
16186846|NCT01495403|Drug|Hydroxychloroquine|daily dosing
16187453|NCT01490866|Drug|Leucovorin|400 mg/m2 Days 1 and 15; IV
16186847|NCT01495377|Drug|Remifentanil|Powder for injection/ infusion fluid solution, 1 mg Infusion TCI 3 ng/ml 60 min ( 0,15 ug/kg/min)
16186848|NCT01495377|Drug|Placebo|Infusion fluid, solution 9 mg/ml ( hydrogenic solution )
16186849|NCT01495377|Drug|Technetium|37-40 MBq( effective dose 0,7 mSv) 99Tc albumin colloid in a volume of 6 ml, infusion velocity 0,1 ml/min via a transnasal catheter
16186850|NCT01495377|Device|Dynamometer (Jamar)|portable hydraulic hand dynamometer to assess grip strength.
16186851|NCT01495364|Biological|NBS10|dosage = 10 or more million CD34+ cells via intracoronary infusion
16186852|NCT01495364|Other|placebo|matching placebo
16186853|NCT01495351|Drug|ABT-888/Bortezomib|ABT-888 is given orally (PO) twice daily (every 12 hours) for 14 days in a 21 days cycle. First dose to be given within 1 hour of Bortezomib on day 1. Planned starting dose is 20 mg PO every 12 hours. Starting dose escalation is planned until an MTD is reached.
16186854|NCT01495338|Drug|AC-170 0.17%|1 drop in one eye at one timepoint
16186855|NCT01495338|Drug|AC-170 0.24% (Formulation 1)|1 drop in one eye at one timepoint
16186856|NCT01495338|Drug|AC-170 0.24% (Formulation 2)|1 drop in one eye at one timepoint
16186857|NCT01495338|Drug|Olopatadine hydrochloride 0.2%/Tears Naturale II|1 drop in one eye at one timepoint
16186858|NCT01495325|Procedure|Forearm Vascular Study|Forearm venous occlusion plethysmography to measure forearm blood flow during intra-arterial infusion of the vasodilators Verapamil (10-100 µg/min), bradykinin (100-1000 pmol/min), sodium nitroprusside (2-8 µg/min) and Acetylcholine (5-20 µg/min).
16186859|NCT01495325|Procedure|Badimon Chamber|Ex-vivo assessment of thrombus formation using the Badimon Chamber
16186860|NCT01495312|Device|SLT (selective laser trabeculoplasty ) SENSIMED Triggerfish|SLT (single session; 180 to 360 degrees of angle will be treated)
16186861|NCT01495299|Device|Phacoemulsification with implantation of intraocular lens (CE-IOL) SENSIMED Triggerfish|Phacoemulsification (standard cataract extraction surgery)
16186862|NCT01495286|Device|EMPI Select Transcutaneous Electrical Nerve Stimulation|Experimental: EMPI Select TENS unit For analgesia, StimCare electrodes will be placed on the baby's legs at specific acupuncture points and electrical stimulation will be administered via a standard EMPI Select TENS unit. For the main study, a low continuous current will be provided with voltage of 3.5 mA. The frequency will be delivered using a stimulation of 10 Hz for 10±1 minutes prior to the heelstick, with continued stimulation during and for 5±1 min after the heel stick. Two sub studies will precede the main safety study, with 6 infants in each, using electrical stimulation intensities that are a fraction of the planned intensity. Infants in sub study 1 will receive electrical stimulation at 1 mA and 2 Hz. Infants in sub study 2 will receive electrical stimulation at 2 mA and 10 Hz.
16186863|NCT01495273|Procedure|Transtracheal injection|Experimental group will undergo transtracheal injection using needle connected to a nerve stimulator device.
16186864|NCT01495273|Procedure|Transtracheal injection|Control group will undergo transtracheal injection with a standard needle/syringe assembly.
16186865|NCT01495260|Drug|N-acetylcysteine|N-acetylcysteine, 800-2400 mg daily for 2 months
16186866|NCT01495260|Drug|lipoic acid|lipoic acid, 300-600 mg daily for 2 months
16186867|NCT01495260|Drug|vitamin E|vitamin E, 150-300 mg daily for 2 months
16186868|NCT01495247|Drug|BEZ235|Doses of oral BEZ235 (BID), supplied as 50mg, 200mg, 300mg or 400mg in SDS sachets, together with standard weekly paclitaxel at a fixed dose (80mg/m²) during 1h by i.v. in infusion.
16186869|NCT01495247|Drug|Paclitaxel|"The paclitaxel infusion will be given in the morning and directly thereafter the BEZ235 dose will be given.
~BEZ235 doses will be escalated in cohorts of 3 to 6 patients guided by an adaptive Bayesian logistic regression model with overdose control until MTD/RP2D has been established. The initial dose level for the first cohort will be 200mg (BID), and then based on the Bayesian model the dose may be escalated to 300mg, 400mg, 500mg or 600mg for the next cohorts."
16186870|NCT01495234|Device|rhBMP-2/BCP device|The rhBMP-2/BCP device consists of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) and the biphasic calcium phosphate (BCP) carrier.
16186871|NCT01495234|Device|rhBMP-2/BCP device|The rhBMP-2/BCP device consists of recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) and the biphasic calcium phosphate (BCP) carrier.
16186872|NCT01495221|Drug|Alfilbercept|All patients will receive 2.0 mg intravitreal aflibercept injection.
16186873|NCT01495208|Drug|Aflibercept|intravitreal aflibercept injection 2mg
16186874|NCT01495195|Drug|High-dose donepezil|Donepezil titrated to 22.5 mg daily
16186875|NCT01495195|Drug|Low-dose donepezil|Donepezil titrated to 10 mg daily
16186876|NCT01495195|Drug|Selegiline|Transdermal selegiline, 6 mg daily
16186877|NCT01495195|Drug|Placebo|microcrystalline cellulose
16186878|NCT01495182|Other|Dietary fiber|A proprietary fiber will be given to subjects
16186879|NCT01495169|Drug|iloperidone (oral tablet)|iloperidone 12 to 24 mg/day followed by 26 weeks of flexible dosing (6 to 24 mg/day)
16186880|NCT01495156|Drug|Lithium treatment in combination with a SGA (Second Generation Antipsychotic)|"All patients will be treated with aripiprazole with a target dose of 10 mg/day and a max daily dose of 30 mg. If aripiprazole is ineffective or not tolerated, it will be tapered and risperidone treatment will be started. If patient had an adequate aripiprazole trial in the past as described above, risperidone will be the initial treatment. Risperidone dosing will begin with 0.5 mg/day on day 1 with a target dose of 2.5 mg/day and a max daily dose of 6mg.
~Subjects in the lithium /adjunctive SGA group will be started at 900 mg/day lithium in thrice daily dosing. The lithium dose will be increased to 1200mg/day on day 4 if lithium has been well-tolerated and symptoms of mania remain, as determined by a phone assessment done by a blinded study physician. The target serum level of lithium will be 1.2 mEq/L (range 0.8 to 1.4 mEq/L)."
16186881|NCT01495156|Drug|Placebo/Adjunctive SGA treatment|"All patients will be treated with aripiprazole with a target dose of 10 mg/day and a max daily dose of 30 mg. If aripiprazole is ineffective or not tolerated, it will be tapered and risperidone treatment will be started. If patient had an adequate aripiprazole trial in the past as described above, risperidone will be the initial treatment. Risperidone dosing will begin with 0.5 mg/day on day 1 with a target dose of 2.5 mg/day and a max daily dose of 6mg.
~Subjects in the placebo /adjunctive SGA group will receive placebo for the entire trial in addition to the adjunctive SGA."
16186882|NCT01495143|Procedure|Posterolateral lumbar fusion surgery|Two MD catheters with 1% lidocaine 1-2 ml are placed in the paraspinal muscle.
16186883|NCT01495130|Procedure|ultrasound imaging|Undergo transrectal ultrasound
16186884|NCT01495130|Procedure|robot-assisted laparoscopic surgery|Undergo robotic-assisted laparoscopic prostatectomy
16186885|NCT01495117|Drug|Povidone-Iodine|7.5% povidone iodine soaping 10% povidone iodine painting
16186886|NCT01495117|Drug|Chlorhexidine gluconate|4% chlorhexidine gluconate soaping 2% chlorhexidine gluconate painting
16186887|NCT01495104|Drug|RO4917838|Multiple doses
16186888|NCT01495104|Drug|valproate|Multiple doses
16186889|NCT01495078|Procedure|Telemonitoring|"Is a computer system designed jointly by engineers and clinical personal of Parc Salut Mar) to be able daily automated selfreported symptom and weight, blood pressure and heart rate monitoring . The system allow weekly follow up throught videoconferences.
~Information from the telemonitoring system is automatically downloaded to a secure Internet site for review by clinicians and nurses."
16186890|NCT01495065|Drug|GSK2251052 750 mg|Treatment A: 750 mg IV GSK2251052 single dose
16186891|NCT01495065|Drug|GSK2251052 1500 mg|Treatment B: 1500 mg IV GSK2251052 single dose
16186892|NCT01495065|Drug|GSK2251052 1500 mg BID|Treatment C: 1500 mg IV GSK2251052 BID or placebo for 12 days
16186893|NCT01495065|Drug|GSK2251052 2250 mg|Treatment D: On Day 1 a single dose of GSK2251052 2250 mg IV administered over 60 minutes; Days 4 - 12 BID doses of GSK2251052 2250 mg IV (for 9 days), fasted
16186894|NCT01495065|Drug|GSK2251052 3000 mg|Treatment E: On Day 1 a single dose of GSK2251052 3000 mg IV administered over 60 minutes; Days 4 - 12 BID doses of GSK2251052 3000mg IV (for 9 days), fasted
16186895|NCT01495065|Drug|GSK2251052 0.9% saline|Treatment P: On Day 1 a single dose of 0.9% saline IV administered over 60 minutes; On Days 4 - 12 BID doses of 0.9% saline (for 9 days), fasted
16186896|NCT01495052|Dietary Supplement|organic naked oat with whole germ (ONOG)|The experimental product was ONOG (Inner Mongolia Sanzhuliang Natural Oats Industry Corporation), which was produced in the northwest part of China, applying with the organic standards. Participants in the 50g and 100g-ONOG plus diet groups were asked to replace their customarily used staple food with oat porridge containing 50g or 100g ONOG.
16186897|NCT01495039|Drug|Nystatin|Systematic nystatin prophylaxis (2 x 106 U per day administered three times daily in the naso-gastric tube)
16186898|NCT01495026|Drug|Dutasteride (0.5mg, fasted state)|Open-label, randomized, single dose, multi-stage, cross-over study
16186899|NCT01495026|Drug|Dutasteride (0.5mg, fed state)|Commercial formulation of Dutasteride 0.5mg
16186900|NCT01495026|Drug|Fixed dose combination capsule containing dutasteride 0.5mg and tamsulosin 0.2mg (fasted state)|FDC with 85%, 65% and 0% of the dose as enteric-coated pellets and with X and/or Y% of the dose as enteric-coated pellets (X and Y to be determined from PK results from Stage 1)
16186901|NCT01495026|Drug|Fixed dose combination capsule containing dutasteride 0.5mg and tamsulosin 0.2mg (fasted state)|FDC containing faster-release enteric-coated pellets
16186902|NCT01495026|Drug|Fixed dose combination capsule containing dutasteride 0.5mg and tamsulosin 0.2mg (fasted state)|FDC bioequivalent to Harnal-D tablets
16186903|NCT01495026|Drug|Fixed dose combination capsule containing dutasteride 0.5mg and tamsulosin 0.2mg (fed state)|FDC bioequivalent to Harnal-D tablets
16186904|NCT01495026|Drug|Harnal-D Tablets with water (fasted state)|Commercial formulation of Harnal-D Tablets
16186905|NCT01495026|Drug|Harnal-D Tablets with water (fed state)|Commercial formulation of Harnal-D Tablets
16186906|NCT01495026|Drug|Harnal-D tablets without water (fasted state)|Commercial formulation of Harnal-D Tablets
16186907|NCT01495013|Drug|1mg Glimepiride/10mg Atorvastatin FDC|1 tablet by mouth once a day
16186908|NCT01495013|Drug|2mg Glimepiride/10mg Atorvastatin FDC|1 tablet by mouth once a day
16186909|NCT01495013|Drug|3mg Glimepiride/10mg Atorvastatin FDC|1 tablet by mouth once a day
16186910|NCT01495013|Drug|4mg Glimepiride/10mg Atorvastatin FDC|1 tablet by mouth once a day
16186911|NCT01495013|Drug|1mg Glimepiride/20mg Atorvastatin FDC|1 tablet by mouth once a day
16186912|NCT01495013|Drug|2mg Glimepiride/20mg Atorvastatin FDC|1 tablet by mouth once a day
16186913|NCT01495013|Drug|3mg Glimepiride/20mg Atorvastatin FDC|1 tablet by mouth once a day
16186914|NCT01495013|Drug|4mg Glimepiride/20mg Atorvastatin FDC|1 tablet by mouth once a day
16186915|NCT01495013|Drug|1mg Glimepiride|1 tablet of Glimepiride and 1 tablet of Atorvastatin co-administered once daily
16186916|NCT01495013|Drug|2mg Glimepiride|1 tablet of Glimepiride and 1 tablet of Atorvastatin co-administered once daily
16186917|NCT01495013|Drug|3mg Glimepiride|1 tablet of Glimepiride and 1 tablet of Atorvastatin co-administered once daily
16186918|NCT01495013|Drug|4mg Glimepiride|1 tablet of Glimepiride and 1 tablet of Atorvastatin co-administered once daily
16186919|NCT01495013|Drug|10mg Atorvastatin|1 tablet of Atorvastatin and 1 tablet of Glimepiride co-administered once daily
16186920|NCT01495013|Drug|20mg Atorvastatin|1 tablet of Atorvastatin and 1 tablet of Glimepiride co-administered once daily
16186921|NCT01495000|Drug|denosumab|60mg subcutaneous injection, single dose
16186922|NCT01495000|Drug|placebo|placebo subcutaneous injection, single dose
16186923|NCT01494987|Drug|Ranolazine|Ranolazine tablet(s) administered orally
16186924|NCT01494987|Drug|Placebo|Placebo to match ranolazine for the duration of the study
16186925|NCT01494987|Drug|Glimepiride|Glimepiride tablets (2 mg or 4 mg) administered orally once daily with the morning dose of study drug or placebo. The target dosing regimen for glimepiride is 4 mg once daily.
16186926|NCT01494987|Behavioral|Diet|Participants are instructed to continue the diet regimen prescribed by their physician.
16186927|NCT01494987|Behavioral|Exercise|Participants are instructed to continue the exercise regimen prescribed by their physician.
16186928|NCT01494974|Device|FP7 Ahmed Glaucoma Drainage Implant|Ahmed Glaucoma Valve model FP7
16186929|NCT01494974|Device|FP8 Glaucoma Drainage Implant|Ahmed Glaucoma Valve model FP8
16186974|NCT01494636|Drug|GSK2339345 (solution)|3, 6, 15, 30, 60 and 120 micrograms (proposed doses). 2 alternating cohorts of 6 subjects. Each subject to receive 3 ascending doses with washout of at least 48 hours between doses. Rinse, Gargle and Spit.
16186975|NCT01494636|Drug|GSK2339345 (nebulised)|25, 100, 250, 1000 and 2000 micrograms (proposed doses). Subjects randomised to receive three ascending doses (with each dose given on two consecutive days). Washout of at least 6 days between treatment periods. Nebulised.
16186976|NCT01494636|Drug|Placebo (0.9% sodium chloride solution)|Administered on Day 1 of one of the treatment periods in part B. Randomised. Nebulised.
16186930|NCT01494961|Behavioral|Couple-oriented post-test HIV counseling|COC is an individual behavioural intervention, strengthening standard post-test HIV counselling delivered to pregnant women after prenatal HIV testing. COC was based on the assumption that developing women's communication skills and self-efficacy during HIV counselling would enable them to discuss HIV and sexual issues with their partners, and yield tangible effects on partner HIV testing. The structure of the COC intervention was adapted from a WHO PMTCT counselling manual and was described in a COC manual, which was used to train the COC counsellors and could also be used during the counselling session. Tested during the pilot phase of the trial, COC was shown to be feasible and acceptable in the four study sites.
16186931|NCT01494948|Other|allergen challenge|nasal challenges with antigen to which they are sensitive to
16186932|NCT01494935|Behavioral|High Glycemic Diet|NORMAL FAT AND GLYCEMIC DIET CONSUMED High FAT AND Glycemic Diet consumed
16186933|NCT01494935|Behavioral|Control diet|Normal fat, normal fat diet
16186934|NCT01494922|Drug|EXC 001 (currently called PF-06473871)|Single dose administered by injection at four different times
16186935|NCT01494909|Dietary Supplement|Ensure plus|Ensure plus sip feeds every 20 min during 6 hours. After 2 hour pancreatic enzyme intake in CF
16186936|NCT01494883|Behavioral|Mindfulness Based Stress Reduction|A weekly training of eight sessions lasting two and a half hours.
16186937|NCT01494870|Procedure|PCI|urgent PCI on admission
16186938|NCT01494857|Drug|Adalimumab|Adalimumab 40 mg from 4 to 1 injection once in two weeks. Total Treatment period - 10 weeks.
16186939|NCT01494844|Device|Respiratory monitor patient interface.|Wear each interface for 20 minutes
16186940|NCT01494831|Behavioral|TF-CBT|15 sessions of group-based, trauma-focused cognitive behavioral therapy
16186941|NCT01494818|Device|Hydrogen peroxide-based contact lens care system|
16186942|NCT01494818|Device|PHMB-containing contact lens solution|
16186943|NCT01494818|Device|Soft contact lenses|Contact lenses identical to habitual prescription worn per usual replacement regimen
16186944|NCT01494805|Biological|rAAV.sFlt-1|1 x 10^10 vector genomes (vg) rAAV.sFlt-1, delivered by subretinal injection
16186945|NCT01494805|Biological|rAAV.sFlt-1|1 x 10^11 vector genomes (vg) rAAV.sFlt-1, delivered by subretinal injection
16186946|NCT01494805|Other|Control (ranibizumab alone)|Patients will not receive rAAV.sFlt-1, but will be eligible for retreatment with ranibizumab (Lucentis).
16186947|NCT01494792|Device|In Vitro Diagnositc aid for diagnosis|
16186948|NCT01494779|Drug|Somatropin|single subcutaneous dose of 5mg
16186949|NCT01494779|Drug|Somatropin|single subcutaneous dose of 5mg
16186950|NCT01494766|Dietary Supplement|L-Tyrosine|L-Tyrosine 750 mg PO every day for 7 days, then increase to 1500 mg PO every day for 7 days, then increase to 2250 mg PO every day for 7 days, then increase to 3000 mg PO every day for remainder of the study.
16186951|NCT01494753|Drug|T2345|One drop at 8.00pm.
16186952|NCT01494753|Drug|Prostaglandin|One drop at 8.00pm.
16186953|NCT01494740|Biological|split-virion, non-adjuvanted vaccine of 7.5 μg|120 infants were assigned to receive 2 dose of 7.5μg split-virion, non-adjuvanted H1N1 vaccine.
16186954|NCT01494740|Biological|split-virion, non-adjuvanted H1N1 vaccine of 15 μg|120 infants were assigned to receive 2 dose of 15μg split-virion, non-adjuvanted H1N1 vaccine.
16186955|NCT01494740|Biological|split-virion, non-adjuvanted vaccine of seasonal influenza|120 infants were assigned to receive 2 dose of split-virion, non-adjuvanted seasonal influenza vaccine.
16186956|NCT01494727|Drug|CJ Amlodipine/Valsartan 10/160mg|single dose
16186957|NCT01494727|Drug|Novartis Exforge 10/160mg|single dose
16186958|NCT01494714|Drug|JNJ 10229570-AAA 1.2% cream|A patch containing the cream will be applied on the back and left for 48 hours on the left side, and 24 hours on the right side.
16186959|NCT01494714|Drug|JNJ 10229570-AAA 2.4% cream|A patch containing the cream will be applied on the back and left for 48 hours on the left side, and 24 hours on the right side.
16186960|NCT01494714|Drug|JNJ 10229570-AAA 3.6% cream|A patch containing the cream will be applied on the back and left for 48 hours on the left side, and 24 hours on the right side.
16186961|NCT01494714|Drug|Color-matched vehicle in a cream formulation containing 0 mg of JNJ 10229570-AAA|A patch containing the cream will be applied on the back and left for 48 hours on the left side, and 24 hours on the right side.
16186962|NCT01494714|Drug|Petroleum jelly|A patch containing the petroleum jelly will be applied on the back and left for 48 hours on the left side, and 24 hours on the right side.
16186963|NCT01494701|Drug|nusinersen|Administered by intrathecal (IT) injection
16186964|NCT01494688|Drug|Paclitaxel|Paclitaxel, at a dose of 80 mg/m^2 will be administered QW for up to 12 weeks.
16186965|NCT01494688|Drug|RO5509554|RO5509554 will be administered Q2W, Q3W or initial biweekly followed by monthly maintenance as intravenous (IV) infusion until disease progression, unacceptable toxicity, death or participant refusal, whichever occurs first.
16186966|NCT01494675|Other|procalcitonin measurement|"The patients assigned to the procalcitonin group had procalcitonin and C reactive protein levels measured at day 0 (bacteremia), 5 or 7 (if positive blood culture) and then every 48 hours until hosptital discharge, death or until the antibiotics were stopped. A predefined procalcitonin protocol was used together with the clinical outcome, to guide the physician´s decision to discontinue antibiotics.
~The procalcitonin protocol encouraged the physician to discontinue the antibiotics when: 1)procalcitonin dropped more than 90% from the baseline peak level or 2)an absolute value below 0,5ng/mL was reached. Cases in which the antibiotic treatment was continued against what the PCT values indicated were categorized as  antibiotic discontinuation overruling"
16186967|NCT01494662|Drug|HKI-272|240 mg orally, once daily
16186968|NCT01494662|Procedure|Surgical Resection|Neratinib concentrations from craniotomy specimen, CSF, plasma Neratinib.
16186969|NCT01494662|Drug|Capecitabine|750 mg/m2 orally, twice daily (1,500 mg/m2 daily) for 14 days followed by 7 days off
16186970|NCT01494662|Drug|HKI-272|160 mg orally, once daily
16186971|NCT01494662|Drug|Ado-Trastuzumab Emtansine|3.6 mg/kg IV every 3 weeks
16186972|NCT01494649|Drug|Test Toothpaste|0.454% stannous fluoride toothpaste
16186973|NCT01494649|Drug|Negative Control Toothpaste|0.76% sodium monofluorophosphate toothpaste
16186977|NCT01494636|Drug|Lidocaine|40mg dose. Administered on Day 2 of one of the treatment periods in part B. Randomised. Nebulised.
16187454|NCT01490866|Drug|Oxaliplatin|85 mg/m2 Days 1 and 15; IV
16186978|NCT01494623|Device|repetitive Transcranial Magnetic Stimulation|Magnetic pulses to specified brain regions.
16186979|NCT01494610|Drug|SERETIDE Rotacaps|The study consists of four treatment periods of 10 +/- 1 days each in a cross-over fashion. Each patient will be administered SERETIDE delivered via a capsule-based inhaler (Rotacaps) twice for two treatment periods and a placebo delivered via a capsule-based inhaler (Rotacaps) twice for two treatment periods in a randomised, double-blind, double-dummy fashion. Dosing is twice daily in the morning and evening over the duration of each treatment period.
16186980|NCT01494610|Drug|SERETIDE Diskus|The study consists of four treatment periods of 10 +/- 1 days each in a cross-over fashion. Each patient will be administered SERETIDE delivered via a multi-dose dry powder inhaler (Diskus) twice for two treatment periods and a placebo delivered via a multi-dose dry powder inhaler (Diskus) twice for two treatment periods in a randomised, double-blind, double-dummy fashion. Dosing is twice daily in the morning and evening over the duration of each treatment period.
16186981|NCT01494597|Drug|isavuconazole|oral
16186982|NCT01494597|Drug|cyclosporine|oral
16186983|NCT01494584|Drug|ezogabine/retigabine|ezogabine dose escalation
16186984|NCT01494558|Other|Chemoradiotherapy Regimen between PC and PE|etoposide 50mg/m2 d1-5, 29-33 and cisplatin 50mg/m2 d1,8,29 and 36 29-33 during radiotherapy paclitaxel 45mg/m2 weekly and carbplatin AUC =2mg/mL/min weekly during radiotherapy
16186985|NCT01494545|Device|Delefilcon A contact lens|Silicone hydrogel contact lens CE-marked for single use, daily disposable wear
16186986|NCT01494532|Drug|ropinirole/L-dopa|Ropinirole as adjunctive therapy with L-dopa
16186987|NCT01494532|Drug|placebo/L-dopa|Placebo as adjunctive therapy with L-dopa
16186988|NCT01494519|Procedure|Surgery with an external ring fixator|Modern ring external fixator is defined as any fixator that has at least 1 ring proximal and 1 ring distal to the fracture site. The rings may be connected to the tibia using any combination of external fixation pins or wires at the surgeon's discretion. There must be at least two pins or wires connected to each ring, and typically there will be at least three pins or wires. Any FDA approved ring fixator meeting this definition from any manufacturer is allowed.
16186989|NCT01494519|Procedure|Definitive fixation with a locked IM nail or plate|"Eligible patients with tibial diaphyseal fractures will typically receive a standard locked IM Nail. The nail must use at least one static interlock proximal to and one static interlock distal to the fracture site. The nail may be placed with either a reamed or unreamed technique.
~Methaphyseal fractures, especially those with fracture lines extending into the joint may be more commonly treated with plate fixation. The plate may be applied in an open or percutaneous fashion. Any combination of locked and/or non-locked screws may be used."
16186990|NCT01494506|Drug|MM-398|"Arm A: MM-398 120 mg/m2 IV Q3W
~Arm C: MM-398 80mg/m2 IV Q2W"
16186991|NCT01494506|Drug|5 Fluorouracil|"Arm B: 5 Fluorouracil 2000 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks
~Arm C: 5 Fluorouracil 2400 mg/m2 IV every 2 weeks"
16186992|NCT01494506|Drug|Leucovorin|"Arm B: Leucovorin 200 mg/m2 IV for 4 weeks followed by 2 weeks of rest every 6 weeks
~Arm C: Leucovorin 400 mg/m2 IV every 2 weeks"
16186993|NCT01494493|Device|rhBMP-2/ACS/allograft bone dowel|The rhBMP-2/ACS used in conjunction with an allograft bone dowel.
16186994|NCT01494493|Procedure|Autogenous bone/allograft bone dowel|An allograft bone dowel containing autogenous bone taken from the patient's iliac crest.
16186995|NCT01494480|Procedure|stem cell transplantation|after stem cell prepared, the patients accepted 4 times stem cell transplantations through lumbar puncture, the time is 3-5days between two treatments. The patient would have to be in the bed at least 6 hours and removed the pillow.
16186996|NCT01494467|Drug|CD5024|CD5024 1% Cream, once daily
16186997|NCT01494467|Drug|Azelaic acid 15% Gel|Topical Gel applied twice daily
16186998|NCT01494454|Device|rhBMP-2/BCP/TSRH® or rhBMP-2/BCP/CD HORIZON® Spinal System|rhBMP-2/BCP device will be used in conjunction with the posterior spinal fixation system, either the TSRH® Spinal System or CD HORIZON® Spinal System.
16186999|NCT01494454|Device|Autograft/TSRH® or autograft/CD HORIZON® Spinal System.|Either the TSRH® Spinal System or the CD HORIZON® Spinal System with autogenous bone taken from the patient's iliac crest.
16187000|NCT01494441|Procedure|rhBMP-2/BCP|The rhBMP-2/BCP device component consists of recombinant human Bone Morphogenetic Protein-2 ( rhBMP-2) and the biphasic calcium phosphate (BCP) carrier.
16187001|NCT01494441|Device|rhBMP-2/BCP/TSRH® Spinal System|rhBMP-2/BCP device will be used in conjunction with the posterior spinal fixation system, the TSRH® Spinal System.
16187002|NCT01494441|Device|Autograft/TSRH® Spinal System|The control device will be autogenous bone from the iliac crest of the patient used in conjunction with the TSRH® spinal System.
16187003|NCT01494428|Device|rhBMP-2/ACS/allograft bone dowel|The rhBMP-2/ACS will be used in conjunction with an allograft bone dowel.
16187004|NCT01494428|Device|Autogenous bone/allograft bone dowel|An allograft bone dowel contains autogenous bone taken from the patient's iliac crest.
16187005|NCT01494415|Drug|Paclitaxel for Injection（Albumin Bound）|concurrent: 60 mg/m2, IV, weekly; consolidation: 260 mg/m2, IV, every 3 weeks
16187006|NCT01494415|Drug|carboplatin|concurrent: AUC 2, IV, weekly; consolidation: AUC 6, IV, every 3 weeks
16187007|NCT01494415|Radiation|thoracic radiation therapy|66 Gy in 33 fractions,both three-dimensional conformal and intensity modulated radiation therapy are allowed
16187008|NCT01494402|Drug|D961S|Oral gelatine capsule
16187009|NCT01494402|Drug|Esomeprazole|Oral HPMC capsule
16187010|NCT01494402|Drug|Buffered acetylsalicylic acid|Tablet
16187011|NCT01494363|Drug|Fluorouracil|5-fluorouracil 2400 mg/m2 (diluted in 1000 ml of 5% dextrose solution) administered as a continuous intravenous infusion over 48 hours every 2 weeks
16187012|NCT01494363|Drug|Leucovorin|Leucovorin 400 mg/m2 (diluted in 250 ml of 5% dextrose solution) as a 2-hour intravenous infusion every 2 weeks
16187013|NCT01494363|Drug|Oxaliplatin|Oxaliplatin 85 mg/m2 (diluted in 250 ml of 5% dextrose solution) given as a 2-hour intravenous infusion every 2 weeks
16187014|NCT01494363|Drug|Irinotecan|Irinotecan 150 mg/m2 (diluted in 250 ml of 0.9% normal saline solution) given as a 90-minute intravenous infusion every 2 weeks
16187015|NCT01494350|Drug|WR 279,396 topical cream|WR 279,396 is a topical antibiotic cream containing paromomycin and gentamicin that will be applied to each lesion once a day for 20 days and covered with a sterile gauze and tape dressing.
16187016|NCT01494337|Procedure|HOLEP|USING HOLMIUM LASER, the prostate adenoma will be enucleated and removed into small pieces
16187017|NCT01494337|Procedure|PVEP-XPS|Greenlight laser will be used with high power setting for selective vaporization of the prostate adenoma, using 180 watt XPS laser machine
16187018|NCT01494324|Other|CT guided percutaneous ablation|Depending on tumor size and location, we will direct a core biopsy needle in the ablated tumor using post-ablation dynamic Liver CT guidance, preferably including liver triphasic examination. The obtained tissue will be detached, collected and submitted to our molecular cytology laboratory. All specimens will be submitted fresh to our molecular cytology laboratory for immediate analysis in order to classify them as viable tumor (V) or apoptotic cells/coagulation necrosis (CN). CT will be performed within 24 hours of the ablation to demonstrate the ablation defect, representing the area of coagulation necrosis. This CT will be used for targeting the ablated tumor for biopsy. All patients will undergo CT again, approximately within 4-8 weeks (+/- 2 weeks) of percutaneous ablation to evaluate for CN in the target tumor or any sign of residual tissue enhancement, representing incomplete treatment.
16187019|NCT01494311|Drug|Lidocaine/tetracaine patch|The lidocaine/tetracaine patch topical anesthetic patch contains 70 mg each of lidocaine and tetracaine. The central area of each patch consists of a Controlled Heat Assisted Drug Delivery pod which is designed to warm the skin to 26-34°C, theoretically enhancing drug absorption and allowing application just 20 minutes before percutaneous procedures. A active or placebo patch was placed on each patient's wrist in the region of the maximum radial artery pulsation. After 20 minutes, the patch was removed.
16187020|NCT01494311|Drug|Placebo Patch|A placebo patch was placed on each patient's wrist in the region of the maximum radial artery pulsation. After 20 minutes, the patch was removed.
16187021|NCT01494311|Drug|Subcutaneous injection of 0.5 ml Lidocain 1%|After removing the patch, a blinded investigator injected 0.5 ml of 1% lidocaine solution. Three minutes after injection, an attempt was made to cannulate the radial artery with a 20-gauge catheter.
16187022|NCT01494311|Drug|Subcutaneous injection of saline|After removing the patch, a blinded investigator injected 0.5 ml saline solution. Three minutes after injection, an attempt was made to cannulate the radial artery with a 20-gauge catheter.
16187023|NCT01494285|Drug|ARK-E021 5%|Topically applied once daily at bedtime
16187024|NCT01494285|Drug|ARK-E021 10%|Topically applied once daily at bedtime
16187025|NCT01494285|Drug|Placebo|Topically applied once daily at bedtime
16187026|NCT01494259|Drug|Bupivacaine|Up to 300cc of 0.5% bupivacaine administered to the mastectomy site via 2 catheters connected to the Symbios GOPump at a rate of 2 cc per hour per catheter over 3 days.
16187027|NCT01494259|Drug|Saline|Up to 300cc of normal saline administered to the mastectomy site via 2 catheters connected to the Symbios GOPump at a rate of 2 cc per hour per catheter over 3 days.
16187028|NCT01494246|Other|electronic mail|Some e-mail will be sent to participants who will be in the intervention group in order to intensify the brief advise received for stop smoking.
16187029|NCT01494233|Drug|250 mg LX1033 tablets|250 mg LX1033 tablets administered orally
16187030|NCT01494233|Drug|Placebo tablet|Matching placebo tablet administered orally
16187031|NCT01494220|Device|Bispectral index monitoring (BIS)|BIS recording electrodes (Aspect Medical Systems. Inc., One Upland Road, Norwood, MA 02062 USA) were applied to the forehead of each patient according to the manufacturer recommendations. The BIS monitor was masked with opaque sheet and BIS data was recorded prior to induction of general anesthesia then continued throughout the procedure. All information obtained from the BIS monitor was continuously downloaded to a computer for offline analysis. The patient's management was not guided by the changes in BIS readings.
16187032|NCT01494207|Behavioral|Wellness counseling|Each participant will receive up to six counseling sessions where the counselor will employ motivational interviewing techniques. The first and last session will be face-to-face with the remaining four sessions being telephonic.
16187033|NCT01494194|Other|Air Structuring Protein|A novel food protein preparation
16187034|NCT01494194|Other|Placebo sorbet|Placebo sorbet for double blind placebo controlled food challenge
16187035|NCT01494168|Procedure|Bariatric surgery (Roux-en-y bypass or sleeve gastrectomy)|Bariatric surgery
16187036|NCT01494155|Drug|Capecitabine|825 mg/m2 BID orally for a total of 10 days (M-F of weeks 2 and 3)
16187037|NCT01494155|Drug|Hydroxychloroquine|400 mg BID from study day 1 until surgery. Dosing resumed upon discharge from hospital
16187038|NCT01494155|Radiation|Proton or Photon Radiation Therapy|Daily, beginning Week 2 for 5 consecutive days
16187039|NCT01494116|Other|900 mL of 0.9% Normal Saline|"The intervention consists of the administration of 900 mL of Normal Saline to the model using the Disconnection- Reconnection method of manual fluid resuscitation. All syringes (syringe size based on study arm) will be prepared by research staff following subject randomization. Each subject will take the prepared syringes, and sequentially administer them to the model by 1. Selecting and connecting a fluid-filled syringe to the catheter extension set to permit fluid administration 2. Manually administering the fluid to the model by depressing the syringe plunger 3. Disconnecting and discarding the empty syringe 4. Repeating steps 1-3 as fast as possible until all 900 mL has been administered."
16187040|NCT01494103|Biological|iCaspase9-transduced T cells|Patients will receive the T cells between 30 and 90 days following transplantation. The T cells will be infused through a catheter line.
16187041|NCT01494103|Drug|AP1903|"AP1903 will be administered if there is development of Grade 1 or greater GvHD.
~Dose: 0.4 mg/kg by IV over 2 hours.
~Up to 3 additional doses may be administered if the GvHD does not respond or gets worse."
16187042|NCT01494090|Drug|Rosuvastatin|5 or 20 mg per day during 6 months
16187043|NCT01494090|Drug|Placebo|5 or 20 mg per day during 6 months
16187044|NCT01494077|Other|Laboratory processing for results|There is no intervention. Extra fluid that is normally discarded will be processed.
16187045|NCT01494051|Behavioral|Diet counseling|Subjects counseled how to follow either the high carbohydrate diet or the high protein diet for 4 months at home.
16187046|NCT01494038|Drug|Isoniazid (INH)|300-mg tablet once daily by mouth, either from entry through Week 28 antepartum (Arm A) or from Week 12 postpartum through Week 40 postpartum (Arm B)
16187047|NCT01494038|Drug|Placebo for isoniazid (INH)|Placebo tablet once daily by mouth, either from Week 28 visit through Week 40 postpartum (Arm A) or from entry until Week 12 postpartum visit (Arm B)
16187147|NCT01493336|Drug|capecitabine [Xeloda]|standard treatment
16187148|NCT01493323|Behavioral|Assessment of personality traits|suicide behaviour , psychic pain, social exclusion, decision making...
16187048|NCT01494025|Behavioral|Diet and Exercise|Subjects underwent a diet regimen targeted to elicit a 10% weight loss. Diets were designed based on the US Dietary Guidelines with caloric deficits individualized for each subject. Aerobic exercise was monitored over approximately 14 weeks, several times per week, to elicit significantly increased VO2max.
16187049|NCT01494012|Radiation|stereotactic body radiation therapy|Undergo SBRT
16187050|NCT01494012|Procedure|positron emission tomography|Undergo FDG-PET/CT
16187051|NCT01494012|Procedure|computed tomography|Undergo FDG-PET/CT
16187052|NCT01494012|Other|questionnaire administration|Ancillary studies
16187053|NCT01494012|Drug|fludeoxyglucose F 18|Undergo FDG-PET/CT
16187054|NCT01493999|Drug|Clopidogrel reloading|Up to three times 600 mg clopidogrel
16187055|NCT01493999|Drug|Prasugrel|60 mg prasugrel in patients with HPR
16187056|NCT01493986|Drug|Ropivacaine|Dosage. Onset time
16187057|NCT01493973|Drug|Epoetin alfa|Epoetin alfa will be administered s.c. at 1200 IU/Kg every 12 weeks
16187058|NCT01493973|Drug|Placebo|Placebo
16187059|NCT01493960|Drug|Cobitolimod|30 mg rectal dose at week 0 and 4
16187060|NCT01493960|Drug|Placebo|Rectal dose at week 0 and 4
16187061|NCT01493947|Drug|Ivermectin 1% cream|Ivermectin 1% cream applied once daily on the face during 16-week plus 36-week extension period.
16187062|NCT01493947|Drug|Metronidazole 0.75% cream|Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.
16187063|NCT01493934|Drug|injection of 6-DIG|Unique injection dose of 92.5 MBq
16187064|NCT01493921|Drug|SR-T100 gel|Patient will be instructed to self-apply approximately 0.3~0.5g of SR-T100 gel on 25 cm squared treatment area (avoiding the periocular areas, lips, and nares) once daily with an occlusive dressing for 16 weeks treatment period.
16187065|NCT01493921|Drug|Vehicle gel|Patient wil be instructed to self-apply approximately 0.3~0.5g of vehicle gel (without active ingredient)per total of 25 cm squared treatment area (avoiding the periocular areas, lips, and nares) once daily with an occlusive dressing for 16 weeks treatment period.
16187066|NCT01493908|Drug|High price|Acetaminophen label as high price
16187067|NCT01493908|Drug|Low price|Acetaminophen label as low price
16187068|NCT01493908|Drug|Low price participants aware paying part|Acetaminophen label as low price; participants aware they are paying part of the full price
16187069|NCT01493908|Drug|No price|acetaminophen. No price - price issue not introduced to participants.
16187070|NCT01493908|Drug|Free of charge|Acetaminophen. participants aware the product is free of charge
16187071|NCT01493895|Device|standard hoem treatment|"All treatments will be carried out by trained study caregivers that will give standard treatment to all the participants under their care.
~Every treatment will consist of the following steps:
~A thorough rinse with an antiseptic soap (Septal scrub) with a stream of warm water.
~Drying of the foot with an absorbable disposable paper towel. Using clean latex gloves the caregiver will beam the ulcer with LLLT 808, B-cure laser machine in the following method."
16187072|NCT01493895|Device|LLLT-808 B-cure laser machine|"From the day of entering the study, ulcers will be treated twice daily regardless of the treatment that was used until then.
~All treatments will be carried out by trained study caregivers that will give standard treatment to all the participants under their care.
~Every treatment will consist of the following steps:
~A thorough rinse with an antiseptic soap (Septal scrub) with a stream of warm water.
~Drying of the foot with an absorbable disposable paper towel. Using clean latex gloves the caregiver will beam the ulcer with LLLT 808, B-cure laser machine in the following method.
~The part of the laser machine from which the laser beam is radiating - the beam guard, will be cleaned with a disposable swab of 70% alcohol. The cleaning will be performed while the machine is pointing downwards."
16187073|NCT01493882|Drug|Placebo|Form = tablet, route = oral administration, once daily from Week 0 to Week 24 for Part 1 and Part 2
16187074|NCT01493882|Drug|JNJ-39758979 30 mg/d|Unit = mg, number = 30, form = tablet, route = oral administration, once daily from Week 0 to Week 24 only for Part 2
16187075|NCT01493882|Drug|JNJ-39758979 100 mg/d|Unit = mg, number = 100, form = tablet, route = oral administration, once daily from Week 0 to Week 24 only for Part 2
16187076|NCT01493882|Drug|JNJ-39758979 300 mg/d|Unit = mg, number = 300, form = tablet, route = oral administration, once daily from Week 0 to Week 24 for Part 1 and Part 2
16187077|NCT01493869|Drug|cabozantinib|3 25-mg strength capsules (75-mg dose) administered as a single oral dose on Day 1 of study participation
16187078|NCT01493856|Drug|Cresto|tablet, rosuvastatin 20mg
16187079|NCT01493856|Drug|Olmetec|tablet, olmesartan medoxomil(CS-866) 40mg
16187080|NCT01493856|Drug|DWJ1276|tablet, Rosuvastatin 20mg and olmesartan medoxomil 40mg
16187081|NCT01493843|Drug|pictilisib|Pictilisib, 260 milligrams (mg) or 340 mg, will be taken orally once daily on Days 1-14 of a 21-day cycle for four cycles. Starting with Cycle 5, pictilisib will be taken once daily continuously.
16187082|NCT01493843|Drug|Placebo|Placebo corresponding to 260 mg or 340 mg pictilisib will be taken orally once daily on Days 1-14 of a 21-day cycle for four cycles. Starting with Cycle 5, placebo will be taken once daily continuously.
16187083|NCT01493843|Drug|bevacizumab|Bevacizumab, 15 milligrams per kilogram (mg/kg) will be administered intravenously (IV) at Day 1 of each 21-day cycle for a maximum of 34 cycles.
16187084|NCT01493843|Drug|carboplatin|Carboplatin will be administered IV to achieve an initial target area under the concentration curve (AUC) of 6 milligrams per milliliter per minute (mg/mL per min) on Day 1 of each 21-day cycle for a maximum of four cycles.
16187085|NCT01493843|Drug|paclitaxel|Paclitaxel will be administered at 200 milligrams per square meter (mg/m^2) IV on Day 1 of each 21-day cycle for a maximum of four cycles.
16187086|NCT01493830|Genetic|fluorescence in situ hybridization|
16187087|NCT01493830|Genetic|gene expression analysis|
16187088|NCT01493830|Genetic|microarray analysis|
16187089|NCT01493830|Genetic|mutation analysis|
16187090|NCT01493830|Genetic|protein analysis|
16187091|NCT01493830|Other|immunohistochemistry staining method|
16187092|NCT01493830|Other|laboratory biomarker analysis|
16187093|NCT01493830|Other|microscopy|
16187094|NCT01493817|Other|laboratory biomarker analysis|Correlative studies
16187095|NCT01493791|Drug|CDB-2914|
16187455|NCT01490853|Drug|Interpheron alpha|Long term outcom after interferon alpha discontinuation or not
16187096|NCT01493778|Drug|turoctocog alfa|Patients will be scheduled to receive treatment with turoctocog alfa for at least 100 exposure days. In most cases, treatment will be given at home with intravenous (i.v., into the vein) self-injection by the parent/caregiver/support person.
16187097|NCT01493765|Other|Simulator training with expert scoring|Residents will be trained using surgical simulation
16187098|NCT01493752|Dietary Supplement|beetroot juice|250mls daily beetroot juice
16187099|NCT01493726|Drug|ALKS 9072, Low dose|IM injection, given monthly
16187100|NCT01493726|Drug|ALKS 9072, Med dose|IM injection, given monthly
16187101|NCT01493726|Drug|ALKS 9072, High dose|IM injection, given monthly
16187102|NCT01493726|Drug|Placebo|Dosed matched placebo IM injection, given monthly
16187103|NCT01493713|Other|Evaluate the correlation of overall different objective response.|Evaluate the correlation of overall different objectives response. Chemotherapeutic agents: XELOX scheme (Xeloda; Oxaliplatin) Device: MDCT (MultiDetector Computed Tomography)
16187104|NCT01493700|Procedure|heated circuit|use electrically heated respiratory circuit (set at 37oC)during mechanical ventilation of anesthetic machine during shoulder arthroscopy
16187105|NCT01493700|Procedure|control|use routine respiratory circuit during mechanical ventilation of anesthetic machine during shoulder arthroscopy
16187106|NCT01493687|Drug|CD5024|CD5024 1% Cream, once daily
16187107|NCT01493687|Drug|Azelaic acid 15% Gel|Topical Gel applied twice daily
16187108|NCT01493674|Dietary Supplement|folic acid|two 5-mg tablets of folic acid
16187109|NCT01493661|Other|Chronic Sleep Restriction|All volunteers will undergo 25% of sleep restriction of their total sleep time at the beginning sleep for five consecutive days. The nights will be monitored by polysomnography.
16187110|NCT01493648|Drug|Vitamin D|Participants will receive weekly doses of 30,000 IU of vitamin D for 3 months.
16187111|NCT01493648|Drug|Placebo|Participants will receive placebo (lactose 100 mg) for 3 months.
16187112|NCT01493635|Other|analgesic ladder|Patients will be managed according to the standard 3 Step approach of the WHO analgesic ladder (Step 1 - Step 2 - Step 3).
16187113|NCT01493635|Other|analgesic ladder|Patients managed according to the WHO analgesic ladder bypassing Step 2, i.e. patients will move from Step 1 of the WHO analgesic ladder to Step 3.
16187114|NCT01493622|Drug|minocycline|variable dose SGA and minocycline,100mg per capsule po（take orally） bid，16 weeks；
16187115|NCT01493622|Drug|placebo|variable dose SGA and 100mg per capsule po（take orally） bid，16 weeks；
16187116|NCT01493609|Behavioral|Click-East app|Computer game, delivered as an iPad app, designed to provide an environment to practice basic social skills.
16187117|NCT01493596|Drug|CPP-115|Appropriate amount of drug substance will be dissolved in juice within 3 hours of dosing.
16187118|NCT01493596|Drug|Placebo|An equal volume of water mixed with juice will be administered.
16187119|NCT01493570|Drug|BI 409306|High dose film-coated tablet
16187120|NCT01493570|Drug|BI 409306|Low dose film-coated tablet
16187121|NCT01493570|Drug|BI 409306|Low dose film-coated tablet
16187122|NCT01493570|Drug|BI 409306 Placebo|Film-coated tablet
16187123|NCT01493570|Drug|BI 409306|Medium dose film-coated tablet
16187124|NCT01493557|Drug|pantoprazole|40 mg q.a.m, p.o.
16187125|NCT01493557|Drug|Pradaxa (dabigatran etexilate)|150 mg or 75 mg b.i.d. (150 mg or 110 mg b.i.d. in Canada)
16187126|NCT01493557|Drug|Pradaxa, within 30 minutes after a meal|Patients randomized to this intervention would be instructed to take their dabigatran 30 minutes after a meal
16187127|NCT01493557|Drug|Pradaxa (dabigatran etexilate)|150 mg or 75 mg b.i.d. (150 mg or 110 mg b.i.d. in Canada)
16187128|NCT01493531|Drug|Lesinurad|Tablets, 200 mg QD
16187129|NCT01493531|Drug|Lesinurad|Tablets, 400 mg QD
16187130|NCT01493531|Drug|Placebo|Tablets, Placebo QD
16187131|NCT01493531|Drug|Allopurinol|Tablets
16187132|NCT01493518|Drug|AMG 557 or PLACEBO|Multiple subcutaneous doses of AMG 557 or Placebo on Days 1, 8, 15, 29, 43, 57 and 71.
16187133|NCT01493505|Drug|AMG 386|AMG 386 15mg/kg IV QW (until progression or unacceptable toxicity develops)
16187134|NCT01493505|Drug|Paclitaxel|Paclitaxel 175 mg/m2 3 hour IV Q3W (6 cycles)
16187135|NCT01493505|Drug|AMG 386 Placebo|AMG 386 Placebo IV QW (until progression or unacceptable toxicity develops)
16187136|NCT01493505|Drug|Carboplatin|Carboplatin AUC 5 or 6 IV Q3W (6 cycles)
16187137|NCT01493479|Drug|90Y Ibritumomab tiuxetan|2 x iv infusions of 11.1 MBq/kg. 1st infusion at week 1, 2nd during weeks 9-13. 2nd infusion may be reduced to 7.4MBq/kg in the case of grade 3 haematological toxicity following the 1st infusion.
16187138|NCT01493479|Drug|Rituximab|"All patients receive 2 x iv infusions of 250 mg/m2 Rituximab given 7-8 days apart prior to each zevalin infusion. The 2nd rituximab infusion is given immediately prior to Zevalin.
~In addition patients with greater than 20% bone marrow involvement at screening receive rituximab pretreatment prior to entering the main treatment phase of the trial, consisting of 4 x weekly iv doses of rituximab(375 mg/m2). This is followed by a repeat bone marrow biopsy, bone marrow involvement must have fallen to <= 20% to enter the main treatment phase of the trial."
16187139|NCT01493453|Genetic|aCD19z cells, IL2, pre conditioning Cyclophosphamide & Fludarabine|aCD19z T cells IV Day 1. The dose of aCD19z T cells will be determined by dose escalation scheme, starting at 10*9 IL2 given as 15 minute IV infusion every eight hours for up to 12 doses Cyclophosphamide (C) 15mg/kg day -7 and day -6, Fludarabine (F) 25mg/m2 day -5 to day -1.
16187140|NCT01493440|Drug|atosiban|Atosiban was administered as a 6.75mg IV bolus dose 30 minutes prior to embryo transfer followed by a 1-hour IV infusion at dose of 18 mg/h then a 2-hour IV infusion at 6 mg/h.
16187141|NCT01493427|Drug|Travoprost 0.004%|Travoprost 0.004% without benzalkonium chloride (BAK), containing Polyquad (PQ) preservative
16187142|NCT01493414|Drug|INC424|All patients enrolled into the study will receive INC424 (ruxolitinib). Starting dose is based on baseline platelet counts, with doses ranging from 5 to 20 mg twice a day. No INC424 dose will exceed 25 mg BID orally.
16187143|NCT01493401|Procedure|Midurethral slings (MUS)|Retropubic, Transobturator, and Single incision MUS can be used.
16187144|NCT01493388|Drug|insulin|Patients will be treated according to routine clinical practice at the discretion of the treating physician.
16187145|NCT01493336|Drug|capecitabine RTD|single oral dose
16187146|NCT01493336|Drug|capecitabine [Xeloda]|single oral dose
16187149|NCT01493323|Behavioral|Assessment of suicidal act|suicide behaviour , psychic pain, social exclusion, decision making...
16187150|NCT01493323|Behavioral|Assessment of depression|suicide behaviour , psychic pain, social exclusion, decision making...
16187151|NCT01493323|Procedure|Cyber ball game|functional neuroimaging
16187152|NCT01493323|Procedure|Iowa Gambling Task|functional neuroimaging
16187153|NCT01493323|Procedure|Microcomputer|functional neuroimaging
16187154|NCT01493323|Procedure|blood sample|blood sample
16187155|NCT01493310|Drug|mifepristone|"Given orally (by mouth)
~Up to 4 doses of mifepristone will be studied (300 mg, 600 mg, 900 mg, 1200 mg)"
16187156|NCT01493310|Drug|placebo|Given orally
16187157|NCT01493310|Drug|nab-paclitaxel|"Given by intravenous infusion (IV)
~Dose of 80 mg/m2"
16187158|NCT01493297|Other|Labeled iron solutions|Labeled iron as FeSO4 (4 mg/test meal)
16187159|NCT01493284|Device|Transcatheter Aortic Valve Implantation|Placement of the SJM Portico aortic valve with a transfemoral delivery system
16187160|NCT01493271|Drug|Placebo|Placebo to RO5093151
16187161|NCT01493271|Drug|RO5093151|oral doses twice daily for up to 28 days
16187162|NCT01493258|Other|iCOPE Intervention group|The study participants in the intervention group will use iCOPE platform providing adapted CERSG content in an interactive and tailored way. The intervention provided by the iCOPE platform will be implemented with the understanding that it should be user-friendly and not time consuming. Initially, all participants will be asked to complete the computer-mediated interactive CERSG module via touch screen tablet PC provided at hospital, in a primary care office, and in senior centers. The total time to complete the curriculum is about 30 min, however the patients will be able to distribute this time throughout a day at their convenience. Once the educational curriculum is completed, the intervention subjects will receive access to other components of the iCOPE platform.
16187163|NCT01493245|Drug|JNS020QD|During weeks 1-3, initial doses of 0.84 mg, 1.7 mg, 3.4 mg, or 5 mg can be increased until individual optimal dose (up to maximum 20.1 mg) is determined. The optimal dose will be administered during the maintenance period (1 week), followed by a long-term treatment (48 weeks) period, where the dose will be adjusted (escalated or reduced) in consideration of the efficacy of the study, and the condition of adverse events. The patches are applied on the skin and exchanged daily (every 24 hours) for consecutive 52 weeks.
16187164|NCT01493232|Other|buccalized occlusion|Making a set of complete denture with new Buccalized Occlusion that is different from current occlusion in my country. In this type just buccal casps of mandibular teeth will be connect to the central fossa of maxillary teeth and lingual casps have not contact.
16187165|NCT01493206|Radiation|intraoperative radiotherapy|intraoperative radiotherapy
16187166|NCT01493193|Other|Endurance training with constant work load|Endurance training with constant work load(n=15): 31min at 65-75% HRmax
16187167|NCT01493193|Other|Pyramid-Training|Pyramid-Training (n=15): One Pyramid consists of 8 one-minute blocks. Those are grouped starting with one block of 70-75% HRmax, followed by one block at 75-80% HRmax and another one at 80-85% HRmax. The top of the pyramid are 2 blocks of 85-90% HRmax. Intensity is lowered afterwards with one block at 80-85% HRmax, followed by one block at 75-80% HRmax and last one at 70-75% HRmax. Two more pyramids follow, each divided by 2min of active recovery at 65-70% HRmax, making it a total of 28min.
16187168|NCT01493193|Other|High-intensity interval training|HIT (n=15): 4x4min intervals at 85-95% HRmax divided by 3x3min of active recovery at 60-70% HRmax, making it a total of 25min
16187169|NCT01493180|Drug|OPC-12759 ophthalmic suspension|OPC-12759 ophthalmic suspension 2%
16187170|NCT01493180|Drug|Sodium hyaluronate ophthalmic solution|Sodium hyaluronate ophthalmic solution 0.1%
16187171|NCT01493167|Other|limb casting/splinting|ankle and arm cast
16187172|NCT01493154|Biological|DNA Vaccine|Patients will receive intramuscular needle injections of pNGVL4a-CRT/E7 (detox) DNA vaccine using the TDS-IM device on Day 1, 22, and 43 for a total of three vaccinations per patient. One day prior to each DNA vaccination, the patient will receive a single low dose of 200 mg/m2 of cyclophosphamide intravenously. The DNA vaccine will be administered in a dose-escalating manner.
16187173|NCT01493154|Drug|Cyclophosphamide|A single low dose of 200 mg/m2 of cyclophosphamide (CTX) will be administered intravenously up to 24 hours (Day 0) prior to each DNA vaccination.
16187174|NCT01493115|Drug|Insulin glargine HOE901|Pharmaceutical form:solution for injection Route of administration: subcutaneous
16187175|NCT01493115|Drug|Insulin glargine - New formulation HOE901|Pharmaceutical form:solution for injection Route of administration: subcutaneous
16187176|NCT01493102|Drug|Vasopressin|Vasopressin will be reduced first (0.01 U/hour)
16187177|NCT01493102|Drug|Norepinephrine|Norepinephrine will be reduced first (0.1 microgram/kg/hour)
16187178|NCT01493089|Drug|Zegerid|20 mg Zegerid suspension to be taken when heartburn occurs. Maximum one dose per day on 3 out of 14 days.
16187179|NCT01493089|Drug|Losec|20 mg Losec capsule to be taken when heartburn occurs. Maximum one dose per day on 3 out of 14 days.
16187180|NCT01493076|Device|Primary cannulation/precut sphincterotomie with the Baby-S|"At the papilla the ankle for cannulation was optimized due to changes of the position of the sphincterotome, its lay in the working channel and the tension of the Albaran-lever and the cutting wire. After successful cannulation, the catheter with the sphincterotome inside was slightly pushed into the duct. If necessary, the baby-sphincterotome was replaced with a guide wire and than conventional endoscopic sphincterotomie was completed with a standard traction-type sphincterotome."
16187181|NCT01493063|Other|Physiopathology|Samples of breastmilk and infant serum and questionnaires.
16187182|NCT01493050|Drug|Sevelamer Carbonate|1600 mg (two 800 mg in the form of tablets or powder to be diluted in water) TID with meals for 26 weeks
16187183|NCT01493050|Drug|calcium carbonate|1200 mg of calcium carbonate TID with meals for 26 weeks
16187184|NCT01493037|Device|PICSO (Pressure-controlled Intermittent Coronary Occlusion|The PICSO catheter has a balloon which is placed in the coronary sinus via the femoral vein. The balloon is inflated and deflated at intervals calculated by an algorithm and adjusted according to the patient's own coronary sinus pressure plateau.
16187185|NCT01493024|Drug|Zirconium silicate (ZS)|Randomized escalating doses (0.3g, 3g and 10g) of ZS (fractionated, protonated microporous Zirconium Silicate, an oral sorbent) administered 3 times daily (tid) with meals.
16187186|NCT01493024|Drug|Placebo|Randomized to mimic escalating doses of experimental drug administered 3 times daily (tid) with meals.
16187187|NCT01493011|Device|chemotherapy & WBH|standard first-line chemotherapy combined with whole-body hyperthemia to treat stage Ⅲb/Ⅳ NSCLC
16187188|NCT01492998|Other|guggulsterone, a natural FXR antagonist.|Gugulipid®, natural extract from Commiphora mukul tree, containing 2.5% guggulsterone
16187189|NCT01492985|Biological|Placebos of GTU-multiHIV B and LIPO-5 vaccines|Placebos corresponds respectively to 1X PBS pH = 7.2 and glucose 5%
16187190|NCT01492985|Biological|GTU-multHIV B vaccine and LIPO-5 vaccine|Vaccines are respectively an HIV-DNA plasmid and a mixture of 5 HIV-lipopeptides.
16187191|NCT01492972|Radiation|Radiation|"Consists of:
~Conformal Proton Radiation Dose: 2.5 Gy (RBE) five days a week in 28 treatments over 5.5-6.5 weeks (total dose: 70 Gy (RBE))
~High Dose Radiation with IMRT alone: 1.8 Gy five days a week in 45 treatments over 9-10 weeks (total dose: 81 Gy)
~Intraoperative LDR Brachytherapy and IMRT: 100Gy Pad103 implant and IMRT 1.8 Gy five days a week in 25 treatments over 5-6 weeks (total dose: 45 Gy)"
16187192|NCT01492972|Drug|Androgen Suppression Therapy|Androgen suppression will begin 8 - 10 weeks prior to the start of RT for a total of 6 (+/- 2) months. Luteinizing Hormone-Releasing Hormone (LHRH) agonist therapy will consist of analogs approved by the FDA (or by Health Canada for Canadian institutions)
16187193|NCT01492959|Drug|insulin human|Insulin human delivered with the InnoLet® device was prescribed according to product labelling to subjects in need of insulin treatment
16187194|NCT01492920|Dietary Supplement|Acetyl-L-Carnitine Hydrochloride|Given orally
16187195|NCT01492920|Other|Placebo|Given orally
16187196|NCT01492920|Other|Questionnaire Administration|Ancillary studies
16187197|NCT01492920|Other|Quality-of-Life Assessment|Ancillary studies
16187198|NCT01492907|Radiation|MeIQx|On the day of administration, the subject will swallow a capsule with a dietary relevant dose of MeIQx, 21 µg, labeled with a very low level of 14-carbon. The radioactive dose for MeIQx, 0.002 mSv (4.3 µCi), or less than an average dental x-ray.
16187199|NCT01492907|Procedure|Pancreatectomy|Patients with operable pancreatic cancer scheduled for a pancreatectomy at the University of Minnesota Medical Center.
16187200|NCT01492894|Drug|Cyclosporins/Tacrolimus|Decrease the dose of calcineurin inhibitor by 1/2 and the drug level will be followed and adjusted to the target level of 50% of the previous levels
16187201|NCT01492894|Drug|Sirolimus|Change from current calcineurin inhibitor to Sirolumus
16187202|NCT01492881|Drug|Vorinostat|Oral, 400mg, taken days 4 through 11 of each cycle.
16187203|NCT01492881|Drug|Bortezomib|subcutaneous injection, 1.3mg/m2, Days 1, 4, 8, and 11 every cycle
16187204|NCT01492881|Drug|pegylated liposomal doxorubicin|Intravenous, 30mg/m2, Day 4
16187205|NCT01492855|Procedure|Arthroscopy|Arthroscopy is offered for the patients who do not benefit from conservative treatment.
16187206|NCT01492855|Behavioral|Non-invasive treatment|All patients will receive information and supervised exercises by a physiotherapist.
16187207|NCT01492829|Behavioral|individual and group-based, community health worker delivered|Pre-test will be individual, tablet-based; participants will receive correct information for incorrect HIV/STI knowledge responses and will watch a brief HIV/STI educational video. This will be followed by participants attending 6 weeks of group educational sessions focused on: HIV, STI, interpersonal relationships, communication and decision-making, mental health and coping, creating social change
16187208|NCT01492816|Behavioral|Community Mobilization|The proposed study seeks to continue C2P community mobilization efforts that have developed coalitions that plan for and bring about structural changes for purposes of reducing Human Immunodeficiency Virus (HIV) incidence and prevalence among youth in targeted communities at nine sites. Earlier phases of C2P have been outlined in ATN Protocols 016a, 016b, 040/040b. The C2P community mobilization model entails: determining a geographic area and population of focus for the coalitions to prioritize their planning and action (accomplished in an earlier phase of C2P); coalitions establishing a shared vision and mission; development of a strategic plan focused on structural changes to reduce risks associated with HIV; process documentation; and feedback as technical assistance to the coalitions.
16187209|NCT01492803|Dietary Supplement|Probiotics|"Probiotic is a live microorganism that when administered in adequate amounts confer a health benefit on the host. It is classified by the FDA as generally recognized as safe (GRAS)"
16187210|NCT01492803|Dietary Supplement|Placebo|The placebo sticks will contain approximately 1 g maltodextrin
16187211|NCT01492790|Procedure|Emergency cholecystectomy first|The intervention is an emergency cholecystectomy without prior common bile duct imaging
16187212|NCT01492790|Procedure|Sequential common bile duct imaging/cholecystectomy|This intervention is a common bile duct imaging modality and, if needed, ERCP first followed in the same hospital stay by a cholecystectomy
16187213|NCT01492751|Behavioral|Quality of life assessment and Clinical evaluation|"quality of life assessed by the Expanded Prostate Cancer Index Composite (EPIC), the Medical Outcomes Study 36-Item Short Form (SF-36) version 2, the Functional Assessment of cancer Therapy, General and Prostate specific (FACT-G and FACT-P, respectively), the International Prostate Symptom Score (IPSS), and the International Index of Erectile Function (IIES). Quality of Life questionnaires are administered centrally by telephone interview before treatment and during follow-up at 1, 3, 6, and 12 months after treatment the first year, then annually until 10 years, and every 5 years thereafter.
~Demographic and clinical characteristics at baseline are recorded at clinical sites and include age, Prostate Specific Antigen (PSA), Gleason grading, prostate volume, risk group and use of neoadjuvant hormonal treatment. According tho the national health guidelines participants are visited every 6-12 months after treatment."
16187214|NCT01492751|Procedure|Radical retropubic prostatectomy surgery|The surgery group underwent radical retropubic prostatectomy. The surgery is performed by a technique based on a modification of the radical retropubic prostatectomy described by Walsh. The prostatectomy is performed in retrograde way, preserving the neurovascular bundles if feasible, controlling the vessels with titanium clips, and avoiding any kind of coagulation to decrease the risk of neurovascular bundle damage. The bladder neck may be preserved on surgeon criteria. Lymph node dissection is rarely performed due to the extremely low risk of metastatic involvement in this subset of patients. The operative time is about 2 to 3 hours and required hospital stay. The patient has a urinary catheter placed for 1 to 3 weeks to facilitate bladder emptying.
16187328|NCT01491880|Behavioral|Therapist-Assisted by Telephone|Parents will receive educational workbooks and ongoing support over the phone from a child anxiety specialist to learn how to use cognitive behavioral therapy skills to manage their children's fears and worries.
16187215|NCT01492751|Radiation|External beam radiotherapy|External beam radiation is carried out with the 3D conformal technique. Patients are treated in a supine position by immobilizing feet and legs. Data from a computed tomography (CT) scan performed with the patient in the treatment position were entered into a 3D treatment-planning system to outline prostate, bladder, and rectum on each slice. Seminal vesicles and regional lymphatics are also contoured if a high risk of involvement was suspected. Applied margins are used to calculate prostate planning target volume (PTV). Custom blocking with Cerrobend blocks or multileaf collimators are designed using beam's eye view, and additional margins were adjusted to provide a minimum dose of 95% to the prostate PTV. Treatment is delivered in 1.8 to 2.0 Gy daily fractions, 5 days per week. Off-line setup control is assessed weekly by comparing orthogonal portal images with the corresponding digitally reconstructed radiographs.
16187216|NCT01492751|Radiation|Prostate Brachytherapy|Brachytherapy is performed by pre-planned procedure. Under epidural anaesthesia, the patient is placed in the lithotomy position (forced lithotomy position larger prostate volumes) and, after probing the patient, the best prostate spatial location is searched, proceeding then to prepare the sterile field and bladder catheterization. A prostate volumetry with a three-dimensional reconstruction is performed and automatically transferred to the scheduler, which processes the images and outlines the prostate, urethra and rectum in each of the sections. In LDR prostate brachytherapy, the prostate gland corresponds to the PTV. The standard dose for 100% isodose is 145 Gy according to the TG-T43 for I-125 sources. Dosimetry calculation of the automatically prescribed dosage is then estimated, with a final manual optimization.
16187217|NCT01492738|Procedure|Acupuncture|After completing questionnaires and anxiety survey, a licensed acupuncturist will insert needles according to Clean Needle Technique into specific acupuncture points. Procedure will last 20 minutes.Following acupuncture treatment, participants will complete anxiety survey and memory test.
16187218|NCT01492725|Device|Intra-arterial Clot Retrieval with Solitaire device|Intra-arterial mechanical clot retrieval with the Solitaire device after patients have received standard therapy with intravenous tissue plasminogen activator (tPA). Clot retrieval involves cerebral angiography and takes approximately 2 hours.
16187219|NCT01492725|Genetic|intravenous tissue plasminogen activator (tPA)|Standard care IV tPA therapy administered as per registered product information
16187220|NCT01492712|Drug|Propofol|Patients in the low-high-low group will receive an infusion of propofol with an initial blood target concentration of 2 mcg/ml. After 15 minutes the target will be increased to 5 mcg/ml and after a further 15 minutes the target will be reduced back to 2 mcg/ml for a further 15 to 30 minutes.
16187221|NCT01492712|Drug|Propofol|Patients in the high-low-high group will receive an infusion of propofol with an initial blood target concentration of 5 mcg/ml. After 15 minutes the target will be reduced to 2 mcg/ml and after a further 15 minutes the target will be increased back to 5 mcg/ml for a further 15 to 30 minutes.
16187222|NCT01492699|Drug|PRX-03140|50 mg PRX-03140 capsules once daily for 2 weeks. After 2 weeks, the dose will increase to 100mg PRX-03140 once daily for 10 weeks.
16187223|NCT01492686|Drug|MCI-186|Two ampoules (60 mg) of MCI-186 injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). The following treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).
16187224|NCT01492686|Drug|Placebo|Two ampoules of placebo injection are intravenously administered once a day, for successive 14 days, followed by 14 days observation period (first cycle). The following treatment (10 days' administration during 14 days) - observation (14 days) cycle is repeated five times (2nd-6th cycles).
16187225|NCT01492686|Drug|MCI-186 in open label phase|All patients after the double blind phase may receive MCI-186 in 7th until 12th treatment - observation cycles at the patients' will.
16187226|NCT01492673|Drug|Cyclophosphamide, Topotecan, and Bevacizumab|The treatment schedule for this study will consist of a 21-day cycle. Dose modification will only occur with administration of the investigational agent, bevacizumab. The schedule of administration is summarized as follows. Administration of bevacizumab will precede the administration of the cyclophosphamide and topotecan by 3 days (Day - 3) to allow for vascular stabilization prior to initiation of chemotherapy. The chemotherapy backbone will consist of cyclophosphamide and topotecan administered as follows: cyclophosphamide 250 mg/m2/day IV over 30 minutes ± 5 minutes on Days 0-4 followed by topotecan 0.75 mg/m2/day IV over 30 minutes ± 5 minutes on Day 0-4 of every cycle. The dosing of cyclophosphamide and topotecan will be fixed.
16187227|NCT01492660|Device|echogenic needle and catheter|Visibility of needle shaft and tip with engraved markers. Ultrasonographic Visibility of catheter tip
16187228|NCT01492660|Device|Neurostimulation to position needle and catheter|The non echogenic needle will be positioned using ultrasonography and neurostimulation and the catheter will be positioned using neurostimulation with plantar or dorsiflexion with 0.6-1.5mA current. 20mL of 2% mepivacaine will be injected via the catheter. Sensory motor block will be evaluated every 5 minutes for 30 mins
16187229|NCT01492647|Drug|JNJ 10229570-AAA 1.2%|One single application of 2.5 mL of the cream will be applied to the face, neck, shoulders, chest and to the upper back areas.
16187230|NCT01492647|Drug|JNJ 10229570-AAA 3.6%|One single application of 2.5 mL of the cream will be applied to the face, neck, shoulders, chest and to the upper back areas.
16187231|NCT01492647|Drug|Color-matched vehicle containing 0 mg of JNJ 10229570-AAA|One single application of 2.5 mL of the color-matched vehicle will be applied to the face, neck, shoulders, chest and to the upper back areas.
16187232|NCT01492634|Other|Prescription of post-dialytic weight based on BCM device|"Prescription of post-dialytic weight target: On a weekly base, the patients are pre-dialytically measured by BCM (body composition monitor).
~The time average fluid overload (TAFO) determines the target range. TAFO is defined as the mean value of pre- and post-dialytic overhydration (TAFO = (OHpre+OHpost)/2). The target range is set asymmetrically around a TAFO of 0.8, from -1.0 L to +0.5, i.e. the TAFO target range will be from -0.2 L to 1.3 L.
~Prescription steps will be calculated weekly for all study patients. TAFO < -0.2 L: Increase post-dialytic weight by Cw x 0.5 kg/week, TAFO between -0.2 to 1.3 L: No action, TAFO between 1.3 to 2.8 L Decrease post-dialytic weight by Cw x 0.5 kg/week, TAFO > 2.8 L: Decrease post-dialytic weight by Cw x 1.0 kg/week."
16187233|NCT01492621|Drug|Desvenlafaxine|Desvenlafaxine 50mg from week 1-8. At week 8 optional increase to 100mg if remission has not been attained.
16187360|NCT01491581|Dietary Supplement|food bar|milk based food bar enriched with micronutrients
16187361|NCT01491568|Device|rhBMP-2/CRM/CD HORIZON® Spinal System|rhBMP-2/CRM with the CD HORIZON® SpinalSystem
16187234|NCT01492608|Drug|Magnesium sulphate|Magnesium sulphate will be given as a loading dose of 5 g infused for 20-30 minutes, followed by a maintenance dose of 1 g per hour. Placebo will be given in identical appearing doses. The maintenance infusion will be continued until delivery appears, or for 24 hours if delivery does not occur or no longer is considered imminent. The infusion will be resumed when delivery is considered imminent again. Another loading dose of 5 g will be given if at least 6 hours has passed after infusion was stopped. The doses that are used in this project are similar to those used for prevention of eclampsia among women with severe preeclampsia.
16187239|NCT01492569|Procedure|electroacupuncture therapy|Undergo TAPS at sham point
16187240|NCT01492569|Other|questionnaire administration|Ancillary studies
16187241|NCT01492569|Procedure|electroacupuncture therapy|Undergo TAPS
16187242|NCT01492556|Drug|Etoposide|Lastet (Etoposide Capsules, 25mg*40 capsules/box), manufactured by Nippon Kayaku Co., Ltd.
16187243|NCT01492543|Drug|Tegafur Gimeracil Oteracil Potassium Capsule|Aiyi® (Tegafur Gimeracil Oteracil Potassium Capsule; T25mg,G7.25mg,O24.5mg*42 capsules/box), manufactured by Jiangsu Hengrui Medicine Co., Ltd.,
16187244|NCT01492530|Behavioral|Men of African American Legacy Empowering Self|Small group intervention. 6 main sessions + 2 booster sessions. Each session lasts 2 hours. Main sessions held over 3 weeks.
16187245|NCT01492530|Behavioral|Standard HIV Education & Risk Reduction|Single, individual counseling and education session. Lasting 20-30 minutes.
16187246|NCT01492517|Other|Ozone exposure|Exposure to 0.3ppm ozone for 2 hours
16187247|NCT01492517|Other|Diesel exhaust|Diesel exhaust generated from a diesel generator delivered to the exposure at a target concentration of 300 μg/m3
16187248|NCT01492517|Other|Ozone18|Exposure to ozone generated using the heavy non-radioactive isotope of oxygen (18O).
16187249|NCT01492517|Other|Clean Air|Exposure to air which has been scrubbed to remove air pollutants including ozone and particles.
16187250|NCT01492504|Drug|Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)|Observational study - No Intervention [(subjects were previously treated with Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052)]
16187251|NCT01492491|Device|SUPRA-HFR|usual dialytic prescription for duration, frequency, acid buffer and anticoagulation regimen.
16187252|NCT01492465|Drug|AMG 876|Ascending single doses of study drug administered SC, with one cohort administered IV
16187253|NCT01492452|Other|standardized guidelines for nursing|Information was provided regarding the preoperative preparation of the child, the same conditions and in the postoperative period, as well as information relating to housing and food for the parents. The conventional orientation took about 15 minutes.
16187254|NCT01492439|Behavioral|Cognitive Remediation|The George Brown College Redirection Through Education (RTE) is a supported education program, offered at no fee to students, that facilitates entry into formal education and employment for persons with mental illness. In addition to the supports available to all RTE students, this group will receive a total of twenty 45 minute computer-based cognitive exercise sessions held twice a week using COGPACK (Ver 6.0,www.cogpack.de). This program facilitates practice across a range of cognitive functions, including attention,psychomotor speed,memory, and executive functions. Participants will also take part in 10 weekly group discussion sessions,approximately 60 minutes in duration, focusing on strategies for management of symptoms and other cognitive deficits in an academic setting.
16187255|NCT01492439|Behavioral|Supported Education|Students enroll in credit courses, such as communications, computer skills, and the psychology of human relations which can lead to eligibility for post-secondary programs. Remedial skills in English, supervised study skills classes and other non-credit courses are included. Vocational testing is offered to help students determine their interests and aptitudes and students try out possible careers as well as their readiness to return to work by engaging in volunteer and work placements. Counsellors are also available to assist students in areas such as learning difficulties and coping with the stresses of school. The overarching goal of this program is to help students explore valued non-illness identities, build confidence, and re-engage with their communities.
16187256|NCT01492426|Drug|Daclatasvir|Film-coated tablet, oral, 60 mg, once daily, 24 weeks
16187257|NCT01492426|Drug|Telaprevir|Film-coated tablet, oral, 750 mg, 3 times daily
16187258|NCT01492426|Drug|Peginterferon alfa-2a|Solution for injection, subcutaneous injection, 180 μg, weekly
16187259|NCT01492426|Drug|Ribavirin|Film-coated tablet, oral, in a body weight stratified dose range of 1000-1200 mg per day
16187260|NCT01492413|Behavioral|online lifestyle counseling and a fortified diet beverage|The fortified diet beverage contains green tea extract (total catechin 167 mg), soluble dextrin fiber (10 g), and caffeine (100 mg).
16187261|NCT01492400|Drug|dexamethasone Intravitreal Implant|Injection of 700 ug dexamethasone intravitreal implant into the study eye on Day 1, Month 5, and Month 10.
16187262|NCT01492400|Drug|ranibizumab|Injection of ranibizumab 0.5 mg into the study eye on Day 1. Patients may receive additional injections on a monthly basis, as needed, for disease progression.
16187263|NCT01492387|Other|Discontinuation of antibiotic therapy|Patients randomized in the Individualized Arm will be treated according to clinical response: antibiotic therapy will be discontinued 48 hours after the day that the patient reaches clinical stability, with at least 5 days of total antibiotic treatment.
16187264|NCT01492374|Drug|BMS-241027|Intravenous (IV), 0.003 mg/kg, Once Weekly, 9 weeks
16187265|NCT01492374|Drug|BMS-241027|Intravenous (IV), 0.01 mg/kg, Once Weekly, 9 weeks
16187266|NCT01492374|Drug|BMS-241027|Intravenous (IV), 0.03 mg/kg, Once Weekly, 9 weeks
16187267|NCT01492374|Drug|Placebo matching BMS-241027|Intravenous (IV), 0.0 mg/kg, Once Weekly, 9 weeks
16187268|NCT01492361|Drug|AMR101|Parallel Assignment
16187269|NCT01492361|Drug|Placebo|Parallel Assignment
16187299|NCT01492114|Dietary Supplement|Resveratrol|"Subjects in the group resvetarol first will be submitted to: 30 days of treatment with Transmax (resveratrol, 500 mg, Biotivia Bioceuticals LLC), one tablet/day in the morning at fasting; then to 30 days of wash-out (no supplementation), and then to 30 days of treatment with placebo (one tablet/day in the morning at fasting)."
16187270|NCT01492348|Behavioral|STEPS UP|"The STEPS UP intervention enhances RESPECT-Mil in several ways:
~Adds care manager training in motivational enhancement, problem solving, and behavioral activation strategies to improve patient engagement.
~Adds preference-based stepped care (i.e., order of steps determined by symptom severity, patient preference, & primary care recommendation) to existing options of pharmacotherapy that includes web-based self-management programs; flexible, modularized telephone-delivered CBT; and individual face to face psychotherapy by specialist.
~Adds option for centralized, telephone-based care management to improve fidelity of intervention delivery, continuity of care, and access to care during off-hours.
~Adds a centralized care team using an electronic symptom registry to provide staffing to care managers, track patients longitudinally, develop stepped-based treatment recommendations, and monitor intervention components."
16187271|NCT01492348|Behavioral|OUC|"Service members randomized to Optimized Usual Care (OUC) will get usual treatment at the site. OUC is RESPECT-Mil, a voluntary, primary care-based implementation program based on the three-component model where, with the assistance and collaboration of a psychiatrist and an on-site nurse-level care manager, service members with symptoms of PTSD and depression are screened, tracked, and treated within the primary care system. Components of the RESPECT-Mil program include (1) equipping and training primary care clinics to screen each visit and use symptom severity tools for diagnosis and assessment; (2) using nurse care managers to assist patients and primary care clinicians; and (3) increasing access to a mental health specialist, often using a clinic specialist."
16187272|NCT01492335|Behavioral|Cognitive Report|Physicians in the Cognitive Report group receive the results of their patients cognitive assessment which includes a clinical diagnosis (Normal, Mild Cognitive Impairment, Dementia) and treatment recommendations
16187273|NCT01492335|Behavioral|Treatment As Usual|Physicians in the Treatment As Usual group do not receive the results of their patients cognitive assessments, they are not given treatment recommendations nor are they told of the patients clinical diagnosis (Normal, Mild Cognitive Impairment, Dementia).
16187274|NCT01492322|Radiation|TRODAT|Smoker will receive a TRODAT injection
16187275|NCT01492309|Device|Active Transcranial Magnetic Simulation|Subjects will be given active TMS 5 days per week for 4 weeks for a total of 20 sessions. Each session will last approximately 10 minutes.
16187276|NCT01492309|Device|Sham Transcranial Magnetic Stimulation|Subjects will be given sham TMS 5 days per week for 4 weeks for a total of 20 sessions. The sham coil contains a shielding mechanism which diverts the magnetic field away from the patient. The sham treatment will last approximately 10 minutes.
16187277|NCT01492296|Procedure|endoscopy after short fasting|patients were evaluated with endoscopy after fasting for two hours
16187278|NCT01492296|Procedure|conventional fasting|patients were evaluated after fasting for 8 hours
16187279|NCT01492283|Other|OGTT|50g waterfree glucose dissolved in 300 ml water consumed over 5 min.
16187280|NCT01492283|Other|IIGI|iso glycemic intravenous (iv) glucose infusion (IIGI) with 20% glucose
16187281|NCT01492270|Procedure|Prostate HistoScanning|Advanced Ultrasound assessment of the prostate
16187282|NCT01492270|Procedure|Multi-parametric MRI|Multi-sequence Magnetic resonance imaging of the prostate
16187283|NCT01492270|Procedure|Transperineal prostate mapping biopsy|Needle biopsy of the perineum via the transperineal route at 5mm intervals guided by the use of ultrasound.
16187284|NCT01492270|Procedure|Image guided biopsies|Biopsies targeted to lesions seen at a) Prostate HistoScanning and b) mp-MRI. In men with an MRI lesion further MRI/US registration biopsies will be obtained
16187285|NCT01492257|Other|Shared Decision Making Intervention|Digital video discs and booklets produced by the Foundation for Informed Medical Decision Making and Health Dialog; a question-prompting phone call with a trained health coach; audio-recordings of the patient-surgeon consultation; and a copy of the surgeon's dictated note.
16187286|NCT01492218|Drug|biphasic human insulin 30|Administered via the NovoLet® device and according to the instructions in the product insert or as instructed by the physician. Individually adjusted dosage as instructed by the physician.
16187287|NCT01492205|Drug|insulin human|All subjects were treated with human insulin administered either by using the NovoLet® pre-filled insulin system or the conventional vial and syringe method. Doctors and nurses must personally administer at least 10 insulin doses to each patient under their individual clinical supervision for assessment of the NovoLet® pre-filled insulin system
16187288|NCT01492192|Drug|18F-RGD-PET-CT and perfusion CT scans on 3 occasions|"Fluciclatide (GE Healthcare) (AH111585) is a small cyclic peptide containing the RGD tripeptide (figure 1), which preferentially binds with high affinity to α¬vβ3 integrins that are up-regulated in angiogenesis.
~The IMP is supplied as a solution for injection, 400 MBq at the reference date and time. Participants will receive one injection of the imaging agent at this dose on 3 occasions"
16187289|NCT01492179|Drug|Normal saline|Normal saline would be administered intravenously and intra-abdominally.
16187290|NCT01492179|Drug|Intravenous Lidocaine|Standardized infusion of lidocaine during 24 h. 100 mg bolus and 50 mg/h during 24 h would be administered.
16187291|NCT01492179|Drug|Intra-abdominal Lidocaine|Lidocaine 5 mg/ml; 100 mg would be administered intraoperatively intra-abdominally and subsequently 50 mg/h as intermittent injection intra-abdominally during 24 h
16187292|NCT01492166|Drug|biphasic human insulin 30|Dose and timing of dose for each subject was at the discretion of the attending physicians based on current clinical practice guidelines
16187293|NCT01492153|Drug|biphasic human insulin|NovoLet® device delivering human insulin. Selection of drug and timing of dose for each patient was at the discretion of the investigator
16187294|NCT01492153|Drug|isophane human insulin|NovoLet® device delivering human insulin. Selection of drug and timing of dose for each patient was at the discretion of the investigator
16187295|NCT01492153|Drug|human soluble insulin|NovoLet® device delivering human insulin. Selection of drug and timing of dose for each patient was at the discretion of the investigator
16187296|NCT01492140|Procedure|Subdermal Injection|Injection of dermal filler
16187297|NCT01492140|Device|Artiste Assisted Injection System|The Artiste™ Assisted Injection System is an air-powered device used to assist clinicians in injecting fluids into the body. The Artiste System was designed specifically to assist in the delivery of dermal fillers for the aesthetic correction of facial wrinkles, folds, and scars.
16187298|NCT01492127|Biological|Blood test|Blood test
16187450|NCT01490866|Drug|Bevacizumab|5 mg/kg Days 1 and 15; IV
16187300|NCT01492114|Dietary Supplement|resveratrol|"Subjects in the group Placebo first will be submitted to: 30 days of treatment with placebo, one tablet/day in the morning at fasting; than to 30 days of wash-out (no supplementation), and then to 30 days of treatment with Transmax (resveratrol, 500 mg) (one tablet/day in the morning at fasting)."
16187301|NCT01492101|Drug|NKTR-102|145 mg/m2 NKTR-102 will be delivered q21day as a 90-minute intravenous (IV) infusion on day 1 of each treatment cycle.
16187302|NCT01492101|Drug|Treatment of Physician's Choice (TPC)|"One of the following Treatment of Physician Choice will be administered per standard of care:
~eribulin, ixabepilone, vinorelbine, gemcitabine, paclitaxel, docetaxel, or nab-paclitaxel"
16187303|NCT01492088|Drug|Brentuximab vedotin|Brentuximab vedotin IV infusion
16187304|NCT01492075|Drug|PCRA (Intermittent injection)|Intermittent injection of LA intraabdominally
16187305|NCT01492062|Device|Multiple Model Predictive Controller|Use of closed loop algorithm in an inpatient environment while closely monitoring blood glucose levels.
16187306|NCT01492049|Behavioral|CRCS patient decision aid (PtDA) video|Participant views PtDA program video in same room as research assistant who offers instruction as needed.
16187307|NCT01492049|Behavioral|Questionnaires|Up to 3 questionnaires (baseline demographics, post-intervention evaluation, and follow up) taking from 5 to 25 minutes to complete each.
16187308|NCT01492049|Behavioral|Essential Hypertension video|Participant views Essential Hypertension video in same room as research assistant who offers instruction as needed.
16187309|NCT01492036|Other|Blood Tests|If participant received retroviral gene therapy, blood test performed to check for a type of infection called the replication-competent retrovirus (RCR). Blood (up to 4 tablespoons each time) drawn every 3 months for first year after gene transfer therapy and once a year after that.
16187310|NCT01492036|Behavioral|Questionnaires|"Once a year during Years 1-5, questionnaire completions that asks about medical history (general health, the status of any medical conditions, and any illnesses or hospitalizations that may have occurred). It should take about 15-30 minutes to complete.
~Once a year during Years 6-15, completion of mailed questionnaire. Participant will be asked about medical history (including if participant has had any children since the infusion) and whether there have been any changes in contact information. The questionnaires should take about 15-30 minutes each time."
16187311|NCT01492023|Behavioral|neuropsychological rehabilitation|attention retraining and teaching compensatory strategies as well as offering psychological support to better cope with cognitive impairments (13 times 60 minutes, once per week during 13 weeks)
16187312|NCT01492010|Dietary Supplement|whey protein|25 g whey protein
16187313|NCT01492010|Dietary Supplement|whey protein supplemented with leucine|6.25 g whey protein supplemented with free form leucine
16187314|NCT01492010|Dietary Supplement|whey protein supplemented with essential amino acids|6.25 g whey protein supplemented with essential amino acids devoid of leucine
16187315|NCT01491997|Behavioral|Mind/Body Medicine Course 1|The subject of the course is Mind/Body medicine. This course is learning about the mind and the body through experiences. The course will meet once every week, for a total of 8 weeks, for roughly 2 hours per class. You will be provided with a schedule of the weekly classes, which will occur on the same day every week, at the same time. Weekly sessions will be run by a teacher and will include other participants in the class. You will also be given homework assignments that are intended to reinforce what you learn in the program. The assignments will require up to 45 minutes, 6 days/week. Following the 6th class, and before the 7th class, there is a voluntary all day Saturday program. Participation in this program is optional. You are expected to continue to incorporate what you learned in the class in your daily routine after you are done with the classes.
16187316|NCT01491997|Behavioral|Mind/Body Medicine Course 2|The subject of the course is Mind/Body medicine. This course is learning about the mind and the body through lectures. The course will meet once every week, for a total of 8 weeks, for roughly 2 hours per class. You will be provided with a schedule of the weekly classes, which will occur on the same day every week, at the same time. Weekly sessions will be run by a teacher and will include other participants in the class. You will also be given homework assignments that are intended to reinforce what you learn in the program. The assignments will require up to 45 minutes, 6 days/week. Following the 6th class, and before the 7th class, there is a voluntary all day Saturday program. Participation in this program is optional. You are expected to continue to incorporate what you learned in the class in your daily routine after you are done with the classes.
16187317|NCT01491984|Device|Laryngoscopy order: 1) MAC, 2) Levitan|Laryngoscopy with MAC, then Levitan
16187318|NCT01491984|Device|Laryngoscopy order: 1) Levitan, 2) MAC|Laryngoscopy with Levitan, then MAC
16187319|NCT01491971|Drug|Degarelix|
16187320|NCT01491958|Drug|atorvastatin|"donors-will receive atorvastatin 40 mg/day orally at least 14 days before anticipated first day of stem cell leukapheresis (LP) until successful completion of leukapheresis according to institutional guidelines.
~Patients-will receive atorvastatin 40 mg starting at least 7 days before initiation of transplant conditioning regimen, to permit a 1 week observation period to rule out any atorvastatin-induced side effects before initiation of transplant conditioning. Patients will continue on atorvastatin with standard GVHD prophylaxis with tacrolimus and methotrexate until end of GVHD prophylaxis according to institutional standard guidelines, or until development of endpoint, which ever should occur first."
16187321|NCT01491958|Drug|Tacrolimus|beginning on Day -2 through approximately Day +180 (that is, approximately 6 months after Day 0)
16187322|NCT01491958|Drug|methotrexate|Day +1, +3, and +6 and +11
16187323|NCT01491945|Device|Ventana Fenestrated Stent Graft System|"The Ventana Fenestrated Stent Graft System consists of the following:
~bifurcated stent graft, Ventana fenestrated proximal extension stent graft, and Xpand renal stent grafts"
16187324|NCT01491932|Drug|AFQ056|AFQ056 will be supplied as oral capsules.
16187325|NCT01491919|Drug|Lisinopril|Subjects will be randomized to Low, Medium, or High dose of Lisinopril
16187326|NCT01491906|Behavioral|Text Messaging and Behavior Counseling|"Participants randomized to the intervention arm will receive a series of components, delivered over 6 months: personalized behavior change goals to be self-monitored via text messaging, group starter counseling sessions, and personalized individual counseling. Each participant will also receive a pedometer to facilitate self-monitoring."
16187451|NCT01490866|Drug|5-Fluorouracil|400 mg/m2 Days 1 and 15; IV
16187329|NCT01491880|Behavioral|Self-Help|Parents will receive educational workbooks to learn how to use cognitive behavioral therapy skills to manage their children's fears and worries independently. Parents will have the option to access support over the phone from a child anxiety specialist.
16187330|NCT01491867|Drug|travoprost 0.003%|Instillation of travoprost 0.003% 1/die in both eyes for 3 months
16187331|NCT01491854|Other|Bloodsampling|Bloodsampling
16187332|NCT01491841|Drug|Bendamustine + Rituximab + Pixantrone|Dose escalation of pixantrone (55mg/m2, 85mg/m2 and 115mg/m2) in combination with static dose bendamustine (120mg/m2 on Day 1 of each 21 day) and rituximab (375mg/m2 on Day 1 of each 21 day cycle).
16187333|NCT01491841|Drug|Pegfilgrastim|6mg administered on Day 2 of each 21 day cycle
16187334|NCT01491828|Device|Kai Strap|Medical device component that vibrates on a subject's neck.
16187335|NCT01491815|Drug|Non-biological DMARD's|Methotrexate: 25mg/week. SSZ: 2 g/day. HCQ: 35 mg/kg/week (Finland and Denmark) Methotrexate: 25mg/week. Prednisolone 20 mg/day tapered in 9 weeks to 5 mg/day, discontinued after 9 months. (Sweden, Norway, Iceland, and the Netherlands)
16187336|NCT01491815|Biological|Cimzia|Certolizumab-pegol: 200 mg s.c. every other week. Methotrexate: 25mg/week
16187337|NCT01491815|Biological|Orencia|Abatacept: 125 mg s.c. every week. Methotrexate: 25mg/week
16187338|NCT01491815|Biological|RoActemra|"Tocilizumab is given as 4-weekly infusions at dosage 8 mg/kg or 162 mg in solution s.c. every week.
~Methotrexate: 25mg/week"
16187339|NCT01491802|Drug|LAMA/LABA|GSK573719/GW642444 inhalation powder used in the Novel Dry Powder Inhaler (DPI): a long-acting beta2-agonist (GSK642444, 25mcg) with a long-acting muscarinic antagonist (GSK573719, 125mcg) combination therapy will be taken once daily for 4 weeks.
16187340|NCT01491802|Drug|LAMA|GSK573719 (125mcg) inhalation powder is a long-acting muscarinic antagonist that will be taken once daily for 4 weeks
16187341|NCT01491789|Device|The VSail-Access simulator|You will be transferred to the VSail cockpit and secured. Following the trainer's instruction, you will sail the simulator around virtual courses displayed on a computer screen, using a joystick to control the rudder angle and a mainsheet to control the set of the sail. You will do this for 1 hour.
16187342|NCT01491763|Drug|Imatinib|600 mg p.o. from day 1 until consolidation
16187343|NCT01491750|Behavioral|GUIDED IMAGERY|DAILY LISTENING TO A GUIDED IMAGERY CD FOR 2 WEEKS BEFORE AND 3 WEEKS AFTER SURGERY
16187344|NCT01491750|Behavioral|PLACEBO|DAILY LISTENING TO AN AUDIO BOOK SEGMENT FOR 2 WEEKS BEFORE AND 3 WEEKS AFTER SURGERY
16187345|NCT01491737|Drug|Pertuzumab|Participants will receive a loading dose of 840 milligrams (mg) as an intravenous infusion on Day 1 of first treatment cycle, followed by 420 mg on Day 1 or Day 2 of each subsequent 3-week cycle until disease progression or unacceptable toxicity.
16187346|NCT01491737|Drug|Trastuzumab|Participants will receive a loading dose of 8 milligrams per kilogram (mg/kg) as an intravenous infusion on Day 1 or 2 of first treatment cycle, followed by 6 mg/kg on Day 1 or Day 2 of each subsequent treatment 3-week cycles until disease progression or unacceptable toxicity.
16187347|NCT01491737|Drug|Aromatase Inhibitor|Participants will receive 1 mg anastrozole or 2.5 mg letrozole orally once daily.
16187348|NCT01491737|Drug|Induction Chemotherapy|Participants receiving induction chemotherapy up to the first 18-24 weeks of the treatment period will receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective pertuzumab and/or trastuzumab infusions at the investigator's discretion.
16187349|NCT01491711|Drug|Methylaminolevulinate PDT in 2 sessions|The methylaminolevulinate creme is applied to the tumour with a margin of 1 cm, ± 1-2 mm thick. Tegaderm®, a gauze and tinfoil is placed over the area to prevent contact with UV light. After 4 hours the area is illuminated with Aktilite (632 nm, 570-670 nm, 75 J/cm2). The light intensity at the lesion surface should not exceed 200 mW/cm2. During illumination a fan is used to cool the treatment site. After the first treatment the skin area is covered to prevent exposure to daylight during 48 hours. After one week (on day 8), the same procedure is repeated. After the treatment the skin area is covered to prevent exposure to daylight during 48 hours. A side-effect of the treatment is a burning pain during illumination and slight erythema afterwards lasting a few days. Sometimes blistering occurs.
16187350|NCT01491711|Drug|Fractionated 5-aminolevulinic acid hydrochloride 20% gel PDT|The 5-ALA HCl 20% gel is applied to the tumour with a margin of 1 cm, ± 1-2 mm thick. Tegaderm®, a gauze and tinfoil is placed over the area to prevent contact with UV light. After 4 hours the area is illuminated with Aktilite (632 nm). During illumination a fan is used to cool the treatment site. The treatment site is covered again with Tegaderm for 2 hours after first treatment, whereupon a second illumination with the same light takes place. A side-effect of the treatment is a burning pain during illumination and slight erythema afterwards lasting a few days. Sometimes blistering occurs. Patients are advised to avoid direct sunlight two days after treatment.
16187351|NCT01491698|Procedure|Roux-en-Y pouch reconstruction (RYP)|Patients will be consented to the study and complete pre-surgical questionnaires. Final randomization will occur once the surgeon in the operating room has confirmed eligibility intraoperatively. The envelope will be opened, and the patient randomized to either receive RYP or RYC. There are no restrictions on how surgeons may create the RYC or RYP reconstruction, except that the pouch must be a minimum of 15 cm in length (from esophago-jejunal anastomosis to end of jejuno-jejunal anastomosis).
16187352|NCT01491698|Procedure|conventional Roux-en-Y reconstruction (RYC)|Patients will be consented to the study and complete pre-surgical questionnaires. Final randomization will occur once the surgeon in the operating room has confirmed eligibility intraoperatively. The envelope will be opened, and the patient randomized to either receive RYP or RYC. There are no restrictions on how surgeons may create the RYC or RYP reconstruction, except that the pouch must be a minimum of 15 cm in length (from esophago-jejunal anastomosis to end of jejuno-jejunal anastomosis).
16187353|NCT01491672|Drug|RAD001|Study drug was supplied as 5 mg tablets in blister packs.
16187354|NCT01491659|Dietary Supplement|Idoform Plus|orally once daily
16187355|NCT01491659|Dietary Supplement|Placebo|orally once daily
16187356|NCT01491633|Drug|Dasatinib|140 mg orally, daily in 28 day cycles
16187357|NCT01491620|Device|532 nm KTP laser|Two laser treatment sessions, 6 weeks apart.
16187358|NCT01491607|Biological|BioThrax|BioThrax, 0.5 mL administered subcutaneously on days 0, 14, and 28.
16187359|NCT01491594|Drug|Eltrombopag|Eltrombopag is taken by mouth daily beginning 5 days before the start of each chemotherapy cycle for 10 days. In the phase 1 part of the study the dose will be 100, 150, 225, or 300 mg.
16187362|NCT01491542|Device|INFUSE® Bone Graft/MASTERGRAFT® Granules/CD HORIZON®|The INFUSE® Bone Graft component of the investigational device consists of recombinant human Bone Morphogenetic Protein-2(rhBMP-2) and an absorbable collagen sponge (ACS)carrier. The MASTERGRAFT® Granules will be used as a type of bulking agent to provide compression resistance.
16187363|NCT01491542|Device|Autogenous Bone / CD HORIZON® Spinal System|The control will be autogenous bone taken from the iliac crest of the patient and placed bilaterally across two adjacent transverse processes and used in conjunction with the CD HORIZON® Spinal System.
16187364|NCT01491529|Drug|AFQ056|"AFQ056 will be supplied as oral modified release tablets in 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg.
~Patients will be randomized in two groups by amantadine status.
~Group 1: Patients are not permitted to take amantadine within 2 weeks prior to the BL1 visit.
~Group 2: Patients must be on a stable and well tolerated dose of amantadine for at least 4 weeks prior to BL1 and must maintain the stable dose of amantadine during the remainder of the study.)"
16187365|NCT01491529|Drug|Placebo|Placebo for AFQ056 will be supplied as oral tablets.
16187366|NCT01491516|Device|TELAMON P™ /INFUSE® Bone Graft/CD HORIZON® Spinal System|The TELAMON P™/INFUSE™ Bone Graft Implant in conjunction with the CD HORIZON® Spinal System for single level lumbar fusion from L1 to S1
16187367|NCT01491503|Drug|Levocetirizine|Levocetirizine dihydrochloride 5mg. PO. Single dose.
16187368|NCT01491503|Drug|montelukast sodium|Montelukast sodium 10mg. PO. Single dose.
16187369|NCT01491503|Drug|Montelukast & levocetirizine|Montelukast sodium 10mg & levocetirizine dihydrochloride 5mg PO. Single dose.
16187370|NCT01491490|Drug|GWP42003 : GWP42004 (40:1)|Capsules taken once a day for 6 weeks
16187371|NCT01491490|Drug|Placebo|Capsules taken once a day for 6 weeks
16187372|NCT01491477|Device|INFUSE™ Bone Graft/CORNERSTONE-SR™ /ATLANTIS™|Cornerstone-SR™ allograft bone containing recombinant human Bone Morphogenetic Protein (rhBMP-2) soaked into an absorbable collagen sponge (ACS) used in conjunction with ATLANTIS™ anterior cervical plate system.
16187373|NCT01491477|Device|Autogenous bone/CORNERSTONE-SR™ /ATLANTIS™|Cornerstone-SR™ allograft bone packed with autogenous iliac crest bone graft used in conjunction with ATLANTIS™ anterior cervical plate system.
16187374|NCT01491464|Device|rhBMP-2/ACS/INTER FIX™|The INTER FIX™ device containing recombinant human Bone Morphogenetic Protein (rhBMP-2) soaked into an absorbable collagen sponge (ACS).
16187375|NCT01491464|Device|Autogenous bone/INTER FIX™|The INTER FIX™ device containing autogenous bone taken from the patient's iliac crest.
16187376|NCT01491451|Device|rhBMP-2/ACS/INTERFIX™|INTERFIX™ device containing recombinant human Bone Morphogenetic Protein-2 (rhBMP-2) and the absorbable collagen sponge (ACS) carrier.
16187377|NCT01491451|Device|Autogenous bone/INTERFIX™|INTERFIX™ device containing autogenous bone taken from the patient's iliac crest.
16187378|NCT01491438|Procedure|PRGF+ Cleaning, debridement of the wound, application of the corresponding dressing and using of antibiotics if necessary|"PRGF once a week (day 1) and conventional treatment twice a week (days 1 and 4)during 12 weeks.
~Types of dressing: enzyme cutting dressing (collagenase), hydrogel, polymeric foam, alginate dressing, hydrocolloid hydrofiber dressing, silver dressing, coal and silver dressing, argentum sulfadiazine dressing, polyurethane or caster hydrocolloid dressing"
16187379|NCT01491438|Procedure|Cleaning, debridement of the wound, application of the corresponding dressing and using of antibiotics if necessary|Twice a week (days 1 and 4) during 12 weeks
16187380|NCT01491425|Device|rhBMP-2/ACS//LT-CAGE® Device|LT-CAGE® device with recombinant human bone morphogenetic protein-2 ( rhBMP-2) and the absorbable collagen sponge (ACS).
16187381|NCT01491425|Device|Autogenous Bone//LT-CAGE® Device|LT-CAGE® device with autogenous bone taken from the iliac crest.
16187382|NCT01491399|Device|INFUSE™ Bone Graft/CORNERSTONE-SR™ /ATLANTIS™|Cornerstone-SR™ allograft bone containing recombinant human Bone Morphogenetic Protein (rhBMP-2) soaked into an absorbable collagen sponge (ACS) used in conjunction with ATLANTIS™ anterior cervical plate system.
16187383|NCT01491399|Device|Autogenous bone/CORNERSTONE-SR™ /ATLANTIS™|Cornerstone-SR™ allograft bone packed with autogenous iliac crest bone graft used in conjunction with ATLANTIS™ anterior cervical plate system.
16187384|NCT01491386|Device|rhBMP-2/ACS/LT-CAGE® Device|LT-CAGE® device with recombinant human bone morphogenetic protein-2 ( rhBMP-2) and the absorbable collagen sponge (ACS).
16187385|NCT01491386|Device|Autogenous Bone/LT-CAGE® Device|LT-CAGE® device with autogenous bone taken from the iliac crest.
16187386|NCT01491373|Device|rhBMP-2/ACS/LT-CAGE® Device|rhBMP-2/ACS inserted into Sofamor Danek's LT-CAGE® device.
16187387|NCT01491373|Device|Autograft/LT-CAGE® Device|LT-CAGE® device filled with autogenous bone taken from the patient's iliac crest
16187389|NCT01491321|Procedure|Bee Venom Acupuncture Therapy|"Bee Venom 1:20,000 under BVA Increment Protocol
~Increment Protocol as
~1st week : SC 0.2cc/day, 2days/week
~2nd week : SC 0.4cc/day, 2days/week
~3rd week : SC 0.8cc/day, 2days/week"
16187390|NCT01491321|Drug|Loxoprofen|60 mg/Tab, pers os 1Tab tid, for 3 weeks
16187391|NCT01491321|Procedure|Placebo|"Normal Saline (0.9% NaCl) under NS Increment Protocol
~Increment Protocol as
~1st week : SC 0.2cc/day, 2days/week
~2nd week : SC 0.4cc/day, 2days/week
~3rd week : SC 0.8cc/day, 2days/week"
16187392|NCT01491308|Other|Red blood cells transfusion|This transfusion policy holds to any time from the start of surgery until discharge. The physicians caring for the patient will be instructed to administer transfusion, one unit at a time, and to measure the patient's hemoglobin concentration after each unit is transfused. In both groups, no further units will be given if the goal hemoglobin was obtained (7.5 g per deciliter for the restrictive arm and 10.0 g per deciliter for the liberal one). All other management decisions are left to the discretion of the patients' physicians. Attending physicians can administer RBC transfusions outside the rules of the protocol (i.e more than 1 unit at a time, without determining pre-transfusion hemoglobin) if severe acute bleeding occurs or other forms of circulatory shock.
16187393|NCT01491295|Drug|Tenofovir disoproxil fumarate|Tenofovir disoproxil fumarate 300mg QD for 36 months (adjust dosage according to renal function)
16187394|NCT01491295|Drug|Lamivudine plus adefovir|Lamivudine 100mg QD for 36 months (adjust dosage according to renal function) Adefovir 10mg QD for 36 months (adjust dosage according to renal function)
16187395|NCT01491282|Other|Enabling and disabling VNS|No intervention
16187396|NCT01491269|Behavioral|Guided Internet-based cognitive behavioural treatment|Eight weeks internet-based cognitive behavioural treatment. Treatment consisted of education, cognitive skills acquisition, behavioural rehearsal, generalization and maintenance.
16187397|NCT01491256|Drug|Pre-procedural High dose atorvastatin loading|Atorvastatin 80 mg loading within 24 hours plus 40mg busting within 2 hours before percutaneous coronary intervention
16187398|NCT01491256|Drug|No pre-procedural high-dose atorvastatin loading|atorvastatin 10mg administration within 24 hours before percutaneous coronary intervention
16187399|NCT01491243|Drug|Intensive treatment with sodium bicarbonate|i.v., sodium bicarbonate (3 ml/kg/h for 1 hour, then 1 ml/kg/h for 7 h) followed by i.v. saline for 48 h in case of abnormal NGAL findings
16187400|NCT01491243|Drug|Standard treatment with saline infusion|i.v. 1 ml/kg/h saline infusion for 48 h in case of abnormal NGAL findings
16187401|NCT01491217|Drug|Paclitaxel|HM30181AK 15 mg tablet + Paclitaxel 10mg, 30mg capsules
16187402|NCT01491204|Drug|Paclitaxel+HM30181|oral, 3times for 4weeks
16187403|NCT01491191|Dietary Supplement|Palmitoylethanolamide|Before surgery: 600 mg cp twice a day After surgery: 600 mg microgranules twice a day for 10 days then 600 mg cps once a day for 20 days
16187404|NCT01491191|Dietary Supplement|Placebo|Before surgery: 1 sugar pill twice a day for 8 days After surgery: 1 sugar microgranules twice a day for 10 days then 1 sugar pill once a day for 20 days
16187405|NCT01491178|Drug|Prazaxa|Dabigatran etexilate
16187406|NCT01491165|Procedure|stem cell transplantation through interventional procedures|one time interventional procedures
16187407|NCT01491152|Device|Galileo® tilt table for children|Two weeks of introduction and 12 weeks of training with side-alternating whole body vibration (WBV) (Galileo® tilt table)
16187408|NCT01491139|Drug|olaparib|Given twice daily. Exposure will escalate by daily dose and duration.
16187409|NCT01491139|Drug|cisplatin|Dose will be 35mg/m2 i.v. once weekly.
16187410|NCT01491139|Radiation|Intensity Modulated Radiotherapy|Total dose will be 70Gy in 35 fractions over 7 weeks.
16187411|NCT01491113|Drug|Levetiracetam 250 mg|Tablet containing Levetiracetam 250 mg
16187412|NCT01491113|Drug|Levetiracetam 500 mg|Tablet containing Levetiracetam 500 mg
16187413|NCT01491100|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|Patients treated with regular dose subcutaneously administered, according to the label and to clinical routine practice.
16187414|NCT01491087|Biological|DTacP IPV//PRP~T combined vaccine: PENTAXIM®|0.5 mL, Intramuscular
16187415|NCT01491074|Drug|Tocilizumab 280 mg|Intravenous administration of 280 mg Tocilizumab (14 ml), mixed with 86 ml 0.9% NaCl
16187416|NCT01491074|Drug|NaCl 0.9% 100 ml|Placebo
16187417|NCT01491061|Drug|Ranolazine|os, 1,000 mg twice 12 hours apart prior to PCI
16187418|NCT01491061|Drug|Placebo|os, two doses 12 hours apart prior to PCI
16187419|NCT01491048|Procedure|THA Physiotherapy|Patients will be randomized into two groups. The control group will receive care from the team of the THA Assistance Protocol already used by the HSG of HCPA without the intervention of physiotherapy. During hospitalization, the group of cases will be submitted to physical therapy associated with the intervention of the team of the THA Assistance Protocol.
16187420|NCT01491048|Procedure|No physiotherapy after THA|No physiotherapy after THA
16187421|NCT01491035|Drug|Vortioxetine|5 mg tablets for 14 days; orally; once daily
16187422|NCT01491035|Drug|Vortioxetine|10 mg tablets for 14 days (initial up-titration with 5 mg/day for 2 days); orally; once daily
16187423|NCT01491035|Drug|Vortioxetine|15 mg tablets for 14 days (initial up-titration with 5 and 10 mg/day for a total of 4 days); orally; once daily
16187424|NCT01491035|Drug|Vortioxetine|20 mg tablets for 14 days (initial up-titration with 5, 10, and 15 mg/day for a total of 6 days); orally; once daily
16187425|NCT01491022|Drug|Ampyra first, then Placebo|10 mg po bid for 4 weeks followed by placebo 4 weeks.
16187426|NCT01491022|Drug|placebo first, then Ampyra|placebo
16187427|NCT01491009|Drug|Remifentanil|IV infusion
16187428|NCT01491009|Drug|Midazolam|IV infusion
16187429|NCT01490996|Drug|Oral complex C3 curcumin + chemotherapy|Daily oral capsule(s)
16187430|NCT01490996|Drug|Chemotherapy only|Standard care chemotherapy
16187431|NCT01490983|Behavioral|no access to eMedonline|patients will be followed for 3 months but will not use eMedonline
16187432|NCT01490983|Behavioral|eMedonline access|patients will be given access to eMedonline use for 3 months
16187433|NCT01490970|Other|Database|Database
16187434|NCT01490957|Other|Database|Database
16187435|NCT01490944|Drug|Iron, Folic acid and Cyanocobalamin|"Total duration= 6 months Iron=100 mg, Folic acid= 500 mcg, Cyanocobalamin 500 mcg weekly supplementation in the form of capsule for 6 weeks
~Iron=100 mg, Folic acid= 500 mcg, Cyanocobalamin 15 mcg weekly supplementation in the form of capsule for next 20 weeks"
16187436|NCT01490944|Drug|Iron and Folic Acid|Iron= 100 mg, Folic acid= 500 mcg weekly supplementation in the form of capsule for 6 months
16187437|NCT01490931|Drug|Ketorolac Nasal Spray|15.75 mg nasal spray delivery to each nostril no more than every six hours
16187438|NCT01490918|Drug|Acarbose|Acarbose 50mg b.i.d at first, at the 2nd week 50mg t.i.d and the 4th week, 100mg tid.
16187439|NCT01490918|Drug|Placebo acarbose|acarbose placebo
16187440|NCT01490918|Drug|placebo metformin|metformin placebo
16187441|NCT01490905|Other|Theramine (A medical food)|Theramine two capsules twice daily for 28 days.
16187442|NCT01490905|Drug|Theraprofen|Theramine two capsules twice daily and ibuprofen 400mg once daily for 28 days.
16187443|NCT01490905|Drug|Ibuprofen|Ibuprofen 400mg once daily for 28 days.
16187444|NCT01490892|Drug|3D HI and SHI of UCA|Perflutren injection, suspension (IV)0.25 ml followed by 3D Harmonic imaging (HI) then (IV) 20 micro-l/kg followed by 3D subharmonic imaging (SHI)
16187445|NCT01490879|Drug|Nexagon® Low Dose|Twice weekly, topical application of Nexagon® low dose in addition to a Removable Cast Walker
16187446|NCT01490879|Drug|Nexagon® Medium Dose|Twice weekly, topical application of Nexagon® medium dose in addition to a Removable Cast Walker
16187447|NCT01490879|Drug|Nexagon® High Dose|Twice weekly, topical application of Nexagon® high dose in addition to a Removable Cast Walker
16187448|NCT01490879|Drug|Nexagon® vehicle|Twice weekly, topical application of Nexagon® vehicle in addition to a Removable Cast Walker
16187449|NCT01490866|Drug|Axitinib|5-mg tablets PO BID
16187456|NCT01490840|Other|Physical exercise|Strength training exercises are performed against own body weight or with training aids like elastic rubber bands or gym balls. All exercises are home-based. To increase balance and core stability, a subset of exercises is performed on shaky ground and/or one-legged. Exercise intensity, duration and frequency are individually assigned by a sports therapist. For each muscle group, a set of exercises of increasing difficulty allows for individual and progressive training adaption. Therapists can choose from an exercise database of approximately 150 different strength exercises with different graduation.
16187457|NCT01490814|Procedure|Electrical isolation of the pulmonary veins|Device: ArcticFront® Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or ArcticFront® Advance Cardiac CryoAblation Catheter System with the FlexCath Steerable Sheath or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
16187458|NCT01490814|Procedure|Electrical isolation of pulmonary veins|Device:NaviStar® ThermoCool® Irrigated Tip Ablation Catheter in combination with 3D mapping system CARTO or any future development generations of this product line, provided they are CE marked and the centre has the experience of at least 10 procedures before including a patient into the study.
16187459|NCT01490801|Genetic|DNA analysis|
16187460|NCT01490801|Genetic|RNA analysis|
16187461|NCT01490801|Genetic|cytogenetic analysis|
16187462|NCT01490801|Genetic|in situ hybridization|
16187463|NCT01490801|Genetic|mutation analysis|
16187464|NCT01490801|Genetic|polymerase chain reaction|
16187465|NCT01490801|Genetic|western blotting|
16187466|NCT01490801|Other|flow cytometry|
16187467|NCT01490801|Other|immunohistochemistry staining method|
16187468|NCT01490801|Other|medical chart review|
16187469|NCT01490788|Drug|Treatment A|TNX-102 2.4 mg - 1 gelcap once under fasting conditions.
16187470|NCT01490788|Drug|Treatment B|Cyclobenzaprine 5 mg, 1 tablet once under fasting conditions
16187471|NCT01490788|Drug|Treatment C|TNX-102 2.4 mg, 1 gelcap once given under fed conditions.
16187472|NCT01490775|Behavioral|no access to eMedonline|patients will be followed for 3 months but will not use eMedonline
16187473|NCT01490775|Behavioral|eMedonline access|patients will be given access to eMedonline use for 3 months
16187474|NCT01490762|Drug|Technosphere Insulin Inhalation Powder using the Gen2C inhaler|Inhalation Powder
16187475|NCT01490762|Drug|Regular Human Insulin|Subcutaneous injection
16187476|NCT01490749|Drug|RAD001|Dose escalation for Phase I; dose for Phase II to be determined after Phase I is completed.
16187477|NCT01490749|Drug|XELOX|Patients will receive two cycles of XELOX.
16187478|NCT01490749|Drug|Carboplatin|Given on a 3 weeks on and 1 week off schedule.
16187479|NCT01490749|Radiation|Radiation|1.8 Gy to 36 Gy; 3 fields or laterals to 50.4 Gy.
16187480|NCT01490736|Drug|Lemuteporfin|lemuteporfin topical solution, 1%
16187481|NCT01490723|Drug|Rituximab|250 mg/m2 by vein preceding 111In Ibritumomab and (90Y) ibritumomab tiuxetan administration, respectively on Days -22 and -14.
16187482|NCT01490723|Drug|111In Ibritumomab|(5.0 mCi +/- 10% of 111In) by vein immediately following the infusion of rituximab on Day -22.
16187483|NCT01490723|Procedure|Planar Scintigraphy Imaging|Day -22, -21 to -16: Planar scintigraphy whole-body imaging started on Day -22 post 111In Ibritumomab infusion prior to voiding, and repeated 3-6 hours later (including Single Photon Emission-Computed Tomography/Computed Tomography (SPECT/CT) scan of the abdomen). Whole-body planar scintigraphy imaging will be repeated between 22-26 hours, then between 70-74 hours, and later between 142-146 hours post 111In Ibritumomab injection.
16187484|NCT01490723|Drug|90Y IbritumomabTiuxetan|Calculated to deliver not below 10 Gy to normal organs (liver, lungs, kidneys) by vein post rituximab on Day -14.
16187485|NCT01490723|Drug|Fludarabine|30 mg/m2 intravenously on Days -5, -4, and -3.
16187486|NCT01490723|Drug|Bendamustine|130 mg/m2 intravenously on D-5, -4 and -3.
16187487|NCT01490723|Drug|Thymoglobulin|1 mg/kg (based on actual body weight) on Days -2 and -1 will be administrated to patients receiving a cord blood (CB) and a matched unrelated donor (MUD).
16187488|NCT01490723|Drug|Tacrolimus|"Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Tacrolimus is changed to oral dosing when tolerated and can be tapered off after day +90 if no Graft versus Host Disease (GVHD) is present.
~For patients receiving cord blood (CB) graft, the Graft versus Host Disease (GvHD) prophylaxis will be with Tacrolimus. Tacrolimus will start on D-2 administrated at starting dose 0.03 mg/kg or 0.015 mg/kg (ideal body weight) by vein starting on D -2 and will be tapered around Day +180 if no GvHD is present."
16187489|NCT01490723|Drug|Methotrexate|5 mg/m2 by vein on Day +1, +3 and +6. Patients receiving an unrelated graft will also be given methotrexate on Day +11 after the transplant.
16187490|NCT01490723|Drug|Mycophenolate|15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or by mouth administered from Days -3 to +45 and then tapered to end by day 100 if there is no Graft versus Host Disease (GVHD).
16187491|NCT01490723|Drug|G-CSF|5 mcg/kg/day subcutaneously beginning Day +7 for patients receiving related and matched unrelated donor (MUD) grafts and on Day 0 for patients receiving a cord blood (CB). G-CSF will continue until the absolute neutrophil count (ANC) is > 500 * 10/L for 3 consecutive days.
16187492|NCT01490723|Procedure|Stem Cell Transplantation|Stem Cell Transplantation on Day 0
16187493|NCT01490710|Other|collection of clinical and biological parameters|Investigation focal lies in hemodynamic monitoring during the last 10 minutes (Cardiac Index Assessment and clinico-biological parameters as: ventilatory and respiratory parameters, NIRS, GDS, Omega Score, heart rate, blood pressure, lactate, BNP, perfusion coefficient…)
16187494|NCT01490710|Other|assign optimal ventilatory mode|End of study: At the end of the second session, clinician will assign optimal ventilatory mode regarding patient clinical response.
16187495|NCT01490697|Drug|Mifepristone|1800 mg tablet, single dose 90 minutes prior to script preparation on Day 7.
16187496|NCT01490697|Drug|d-Cycloserine|100 mg capsule, single dose, taken 4 hours prior to to mifepristone on Day 7.
16187497|NCT01490697|Drug|Placebo-matching Mifepristone|Placebo-matching mifepristone tablets
16187498|NCT01490697|Drug|Placebo-matching d-Cycloserine (DCS)|Placebo-matching DCS capsules
16191246|NCT01462630|Other|laboratory biomarker analysis|Correlative studies
16187499|NCT01490671|Drug|1% tenofovir gel|One applicator of 1% tenofovir gel will be inserted by the participant into the vagina once each day for 28 days or until delivery, whichever comes first
16187500|NCT01490671|Drug|Placebo gel|One applicator of placebo gel will be inserted by the participant into the vagina once each day for 28 days or until delivery, whichever comes first
16187501|NCT01490658|Drug|repaglinide|Single dose of 2 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with metformin as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
16187502|NCT01490658|Drug|metformin|Single dose of 500 mg tablets administered immediately prior to a standard high fat breakfast concomitantly with repaglinide as separate tablets. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
16187503|NCT01490658|Drug|repaglinide and metformin combination tablet|Single dose of 2 mg repaglinide/500 mg metformin (NN4440 2/500) or 1 mg repaglinide/500 mg metformin (NN4440 1/500)administered immediately prior to a standard high fat breakfast. Subjects will be randomised to receive trial drug on 3 separate dosing visits in varying order out of 6 possible treatment periods
16187504|NCT01490632|Drug|Placebo|Administered orally
16187505|NCT01490632|Drug|Baricitinib|Administered orally
16187506|NCT01490619|Behavioral|Healthy Thinking In Teens|9 sessions. Manualized and group based program. Each session lasts 90 minutes. Sessions occur approximately every other week.
16187507|NCT01490619|Other|Advanced Diabetes Education.|9 sessions. Manualized and group based program. Each session lasts 90 minutes. Sessions occur approximately every other week.
16187508|NCT01490606|Other|knee OA project|"physical therapy in OA Knee project, total of 12 sessions, 6 group therapies amd 6 one on one therapy."
16187509|NCT01490606|Other|conventional PT|12 SESSIONS OF CONVENTIONAL PHYSICAL THERAPY
16187510|NCT01490593|Behavioral|Public Health strategies|It is hoped that by recording of the data (i.e. locations and mechanisms of eye injuries), we may be able to develop public health strategies to prevent further injuries. For example, encouraging more visor wear in hockey games if we notice increased prevalence of hockey eye injuries with no visor.
16187511|NCT01490580|Drug|atropine+ propofol|Atropine bolus: 20 µg/kg Propofol injected over 60 seconds: 1 mg/kg for infants < 1000g - Renewable once 2.5 mg/kg for infants > 1000G - Possible additional dose of 1 mg/kg
16187512|NCT01490580|Drug|atropine + atracurium + sufentanil|Atropine bolus: 20 µg/kg Atracurium: 0.3 mg/kg- Possible additional dose of 0.1 mg/kg Sufentanil: 0.1 µg/kg for infants < 1000g 0.2 µg/kg for infants > 1000g
16187513|NCT01490567|Drug|Donepezil|5 mg/day
16187514|NCT01490567|Drug|placebo|placebo 5mg/d
16187515|NCT01490554|Procedure|autologous fibroblasts grafts|Autologous cultured fibroblasts will be grafted in facial skin
16187516|NCT01490515|Procedure|non-invasive metabolomic profiling|non-invasive metabolomic profiling of IVF human embryos
16187517|NCT01490515|Other|morphological evaluation|Simple microscopic observation of embryos and evaluation of morphological characteristics
16187518|NCT01490502|Drug|Vitamin D3|Patients will be assigned to low dose (600 IU/day) versus high-dose (5000 IU/day) of vitamin D3 as an add-on therapy to glatiramer acetate (Copaxone).
16187519|NCT01490489|Other|blood sample and doppler Ultrasound of uterine arteries|"36 ml of blood samples (serum and plasma) will be collected
~After a bed rest supine for 15 minutes, ultrasound Doppler from each of the uterine arteries will be performed to search for Notch"
16187520|NCT01490476|Drug|RAD001|10 mg per os / day or 05mg per os / day with 12 month
16187521|NCT01490450|Biological|Placebo matching BMS-945429|Injection, Subcutaneous, 0 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label
16187522|NCT01490450|Biological|BMS-945429|Injection, Subcutaneous, 25 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label
16187523|NCT01490450|Biological|BMS-945429|Injection, Subcutaneous, 100 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label
16187524|NCT01490450|Biological|BMS-945429|Injection, Subcutaneous, 200 mg, every 4 weeks, Short term:24 weeks, Long term: After 24 Wk, selected dose, open-label
16187525|NCT01490437|Drug|Pemetrexed|Pemetrexed 500 mg/m2 IV over 10 minutes on D1 every 3 weeks
16187526|NCT01490437|Drug|Cisplatin|Cisplatin 70 mg/m2 IV over 60 minutes on D1 every 21 days
16187527|NCT01490437|Drug|Dexamethasone|Dexamethasone 4 mg bid PO from D-1 to D2 every 3 weeks
16187528|NCT01490437|Drug|Vitamins|Folic acid 350 ug - 600 ug daily from D-7 daily vitamin B12 1,000 ug every 9 weeks from D-7
16187529|NCT01490411|Drug|Placebo|The drug tested in this study (rBet v1-FV) was given as a subcutaneous (just under the skin) injection. Patients received at least 10 injections of Placebo or rBet v1-FV, administered in increasing doses weekly for 10 weeks, up to one of the maximum concentrations.
16187530|NCT01490411|Biological|rBet v1-FV|The drug tested in this study (rBet v1-FV) was given as a subcutaneous (just under the skin) injection. Patients received at least 10 injections of Placebo or rBet v1-FV, administered in increasing doses weekly for 10 weeks, up to one of the maximum concentrations.
16187531|NCT01490411|Biological|rBet v1-FV|The drug tested in this study (rBet v1-FV) was given as a subcutaneous (just under the skin) injection. Patients received at least 10 injections of Placebo or rBet v1-FV, administered in increasing doses weekly for 10 weeks, up to one of the maximum concentrations.
16187532|NCT01490411|Biological|rBet v1-FV|The drug tested in this study (rBet v1-FV) was given as a subcutaneous (just under the skin) injection. Patients received at least 10 injections of Placebo or rBet v1-FV, administered in increasing doses weekly for 10 weeks, up to one of the maximum concentrations.
16187533|NCT01490411|Biological|rBet v1-FV|The drug tested in this study (rBet v1-FV) was given as a subcutaneous (just under the skin) injection. Patients received at least 10 injections of Placebo or rBet v1-FV, administered in increasing doses weekly for 10 weeks, up to one of the maximum concentrations.
16187534|NCT01490398|Drug|Rosuvastatin|After baseline assessment, the starting dose of rosuvastatin 10 mg will be given to study patients. If tolerated and LDL-C is > 100mg/dL after 2-4 weeks, the dose will be increased to 20 mg. Rosuvastatin treatment is scheduled to continue for 1 year without no further dose titration, and each patient will be followed at 2 months, 6 months and 1 year.
16187535|NCT01490385|Device|LED Phototherapy|
16191841|NCT01458197|Drug|Tarafenacin 0.2 mg|Capsule, qd, 12 weeks
16187536|NCT01490359|Behavioral|Men Making a Difference HIV/STD Risk Reduction Intervention|Developed based on social cognitive theory and extensive formative research, Men Together Making a Difference HIV/STD risk-reduction intervention consists of 6 75-minute modules designed to increase beliefs that support condom use; skill and self-efficacy to use condoms; and HIV/STD risk-reduction knowledge. Two modules are implemented in each of 3 weekly sessions. It is highly structured and implemented in small groups of 9 to 15 men led by a male, isiXhosa-speaking facilitators using standardized intervention manuals. It includes interactive exercises, games, brainstorming, role-playing, take-home assignments, group discussions, and videos, produced specifically for the interventions, shot in authentic township settings, including a shebeen (i.e., an informal alcohol outlet).
16187537|NCT01490359|Behavioral|Health Promotion Control|The health-promotion intervention was designed to control for non-specific features including group interaction and special attention. It was structurally similar to the HIV/STD risk-reduction intervention in that it contained activities similar to the HIV/STD risk-reduction intervention but focused on behaviors linked to the risk of heart disease, hypertension, stroke, diabetes, and certain cancers-leading causes of morbidity and mortality among South Africans. It also consisted of 6 75-minute modules implemented 2 modules per week during 3 weekly sessions led by isiXhosa speaking male facilitators. It was designed to increase fruit and vegetable consumption and physical activity and decrease excessive alcohol consumption.
16187538|NCT01490346|Drug|Initiation of anti-retroviral therapy|Subjects begin taking a preferred initial anti-retroviral regimens as determined by their primary care provider. Intracellular levels of those medications are measured.
16187539|NCT01490333|Dietary Supplement|Vitamin D3|The vitamin D3 will be taken daily.
16187540|NCT01490320|Behavioral|AAP Handout entitled, Pulling the Plug on Violence.|This handout is two pages and is part of the Connected Kids Program, American Academy of Pediatrics
16187541|NCT01490320|Behavioral|Play Nicely Program|Multimedia program available at www.playnicely.org.
16187542|NCT01490320|Other|Control Group|Standard care in primary care clinic.
16187543|NCT01490307|Behavioral|Family Check-Up|The Family Check-Up starts with a rapport-building session that allows therapists to gauge parents' concerns and motivation for change. This is followed by a thorough assessment of individual family strengths and weaknesses, utilizing parent and child questionnaires and family video observations. Parents then receive feedback on the results of the assessment using motivational interviewing techniques. Attention is focused on parents' and children's readiness to change, as well as the delineation of specific change options. Families may continued to receive tailored intervention services using the Everyday Parenting Curriculum.
16187544|NCT01490294|Drug|Gadobutrol (Gadavist,Gadovist, BAY86-4875)|0.01 mmol/kg BW (0.01 mL/kg) for stress MRI and 0.01 mmol/kg BW (0.01 mL/kg) for rest MRI (total dose 0.02 mmol/kg)
16187545|NCT01490294|Drug|Gadobutrol (Gadavist,Gadovist, BAY86-4875)|0.025 mmol/kg BW (0.025 mL/kg) for stress MRI and 0.025 mmol/kg BW (0.025 mL/kg) for rest MRI (total dose 0.05 mmol/kg)
16187546|NCT01490294|Drug|Gadobutrol (Gadavist,Gadovist, BAY86-4875)|0.05 mmol/kg BW (0.05 mL/kg) for stress MRI and 0.05 mmol/kg BW (0.05 mL/kg) for rest MRI (total dose 0.1 mmol/kg)
16187547|NCT01490294|Drug|Gadobutrol (Gadavist,Gadovist, BAY86-4875)|0.1 mmol/kg BW (0.1 mL/kg) for stress MRI and 0.1 mmol/kg BW (0.1 mL/kg) for rest MRI (total dose 0.2 mmol/kg)
16187548|NCT01490281|Behavioral|water-based exercise|Interventions will consist of aerobic, muscular strength and flexibility exercises in the water
16187549|NCT01490281|Behavioral|land-based exercise intervention|Interventions will consist of aerobic, muscular strength and flexibility exercises in the land
16187550|NCT01490268|Drug|Sufentanil, Hydromorphone|Intraoperatively: Target controlled infusion with 0.4 ng/ml Sufentanil, Postoperatively: Patient-controlled analgesia with target-controlled infusion of Hydromorphone
16187551|NCT01490268|Drug|Sufentanil, Hydromorphone|Intraoperatively: Target controlled infusion with 0.8 ng/ml Sufentanil, Postoperatively: Patient-controlled analgesia with target-controlled infusion of Hydromorphone
16187552|NCT01490255|Drug|Ranolazine|os, 750 mg, twice per day, for 15 days
16187553|NCT01490255|Drug|Amlodipine|os, 10 mg, once daily, 15 days
16187554|NCT01490229|Drug|Ezetimibe|os, 10 mg, once daily, 1 year
16187555|NCT01490229|Drug|Nutraceuticals|os, 1 pill containing red yeast rice 200 mg, policosanol 10 mg, and berberine 500 mg, once daily, 1 year
16187556|NCT01490216|Drug|lisdexamfetamine|20mg q.d. to 70mg b.i.d
16187557|NCT01490203|Drug|Gd-EOB-DTPA|"Gd-EOB-DTPA enhanced MRI will be obtained within 1 week before, and within 3 to 5 days after surgical resection of the liver.
~Gd-EOB-DTPA will be administered intravenously with an amount of 0.1mL/kg, 1mL/sec injection rate, followed by saline infusion."
16187558|NCT01490203|Drug|Gd-EOB-DTPA|"Gd-EOB-DTPA enhanced MRI will be performed within 3 days of obtaining ICG R15 test.
~Gd-EOB-DTPA will be administered intravenously with an amount of 0.1mL/kg, 1mL/sec injection rate, followed by saline infusion."
16187559|NCT01490203|Procedure|MRI|"Gd-EOB-DTPA enhanced MRI will be obtained within 1 week before, and within 3 to 5 days after surgical resection of the liver.
~Multiphasic MRI including dynamic hepatocyte specific phase will be performed for evaluation of hepatic extraction fraction, with 25 phase dynamic MRI obtained until 30 minutes after contrast injection."
16187560|NCT01490203|Procedure|MRI|"Gd-EOB-DTPA enhanced MRI will be performed within 3 days of obtaining ICG R15 test.
~Multiphasic MRI including dynamic hepatocyte specific phase will be performed for evaluation of hepatic extraction fraction, with 25 phase dynamic MRI obtained until 30 minutes after contrast injection."
16187561|NCT01490190|Drug|Ethinylestradiol + Etonogestrel Vaginal Ring (NuvaRing)|Three cycles of NuvaRing use, each cycle consisting of etonogestrel 0.120 mg and ethinylestradiol 0.015 mg over a period of 21 days followed by 7 ring-free days.
16187562|NCT01490177|Drug|Food proteins|Oral ingestion of Food proteins
16187563|NCT01490151|Device|TTR controller (Medtronic)|Subjects will arrive in the morning and the TTR controller (Medtronic) will be initialized, and then they will give their usual premeal insulin bolus for breakfast. At lunch, they will either have a low glycemic index meal or a high glycemic index meal and the meal bolus will be omitted. The device will be turned off before dinner, they will have their usual insulin bolus for dinner, eat dinner, and then be discharged to home. On another admission, they will receive an insulin dose before lunch which will be 120% of their usual insulin bolus.
16187564|NCT01490125|Drug|QVA149|QVA149 110/50 μg hard non-gelatin capsule, inhalation/blister once a day via SDDPI
16188030|NCT01486550|Drug|Sodium Chloride 9mg/ml|7,5 ml/kg in the first hour and then 5 ml/kg
16187565|NCT01490125|Drug|Tiotropium|Tiotropium 18 ug hard gelatin capsule, inhalation/ blister once a day via HandiHaler® device
16187566|NCT01490125|Drug|Placebo to QVA149|Placebo 0 mg hard non-gelatin capsule, inhalation/ blister once a day via SDDPI
16187567|NCT01490125|Drug|Placebo to tiotropium|Placebo 0 mg hard gelatin capsule, inhalation/ blister once a day via HandiHaler® device
16187568|NCT01490125|Drug|Salbutamol/albuterol|salbutamol/albuterol (containing CFC-free propellant -HFA 134a) inhaler used as rescue medication when needed.
16187569|NCT01490112|Drug|insulin aspart|Subjects who had a first drug date on NovoRapid® were prescribed to inject insulin aspart using vial, FlexPen, NovoLet or Penfill devices. Injected subcutaneously (s.c., under the skin) immediately before meals for 24 weeks
16187570|NCT01490099|Drug|insulin detemir|One single dose of insulin detemir produced by current process and the NN729 process injected subcutaneously on two separate dosing visits in varying order
16187571|NCT01490086|Drug|RP5063|daily
16187572|NCT01490086|Drug|placebo|daily
16187573|NCT01490086|Drug|RP5063|daily
16187574|NCT01490086|Drug|RP5063|daily
16187575|NCT01490086|Drug|aripiprazole|daily
16187576|NCT01490073|Drug|Insertion of nitroglycerin ointment|Nitroglycerin ointment inserted into the vagina 30-45 minutes prior to IUD insertion
16187577|NCT01490073|Drug|Insertion of placebo ointment|Placebo ointment inserted into the vagina 30-45 minutes prior to IUD insertion
16187578|NCT01490060|Drug|Fosaprepitant|150 mg administered intravenously, delivered in either single dose or two doses, on Day 1 for single dose and on Days 1 and 4 for two doses, varying between Cycle 1 or Cycle 2 depending upon randomization to arm.
16187579|NCT01490060|Drug|Dexamethasone|Intravenous push (IVPB) daily for 5 days (12 mg on day 1, and 8 mg on days 2-5)
16187580|NCT01490060|Drug|5HT3 receptor antagonist|5HT3 receptor antagonist as standard of care 30 minutes prior to chemotherapy
16187581|NCT01490060|Drug|Ifosfamide-based chemotherapy (AI)|Doxorubicin + Mesna + + Ifosfamide + Vincristine, chemotherapy cycles repeated every 3-4 weeks for up to 6 cycles. Chemotherapy drugs listed separately, individual dosages, etc.
16187582|NCT01490060|Drug|Doxorubicin|25 mg/m^2/day IV continuous infusion for 72 hours on days 1, 2, and 3, completing infusion on day 4 (total dose: 75 mg/m^2) as part of AI Chemotherapy.
16187583|NCT01490060|Drug|Mesna|Prior to ifosfamide (Day 1) - 500 mg/m^2 (20% of ifosfamide dose) given simultaneously with ifosfamide and then daily continuous infusion (Days 1-4 completing infusion on day 4) - 1,500 mg/m^2/day (60% of daily ifosfamide dose) for a total of 6 gm/m^2. The mesna infusion complete 24 hours after last dose of ifosfamide.
16187584|NCT01490060|Drug|Ifosfamide|2.5 g/m^2 IV bolus over 3 hours on days 1, 2, 3, 4 (total dose: 10 g/m^2).
16187585|NCT01490060|Drug|Vincristine|2 mg IV by rapid infusion (Day 1) may be given to participants with sarcomas of small cell histology.
16187586|NCT01490047|Drug|Recombinant human TNF-α|Infusion will be done over 60 minutes, preferably via central venous catheter. Will immediately follow the infusion of Liposomal doxorubicin.
16187587|NCT01490047|Drug|Liposomal doxorubicin|Infusion over 60 minutes
16187588|NCT01490047|Drug|Caelyx|Administration of Caelyx® will be done first, as infusion in 250 ml D5W, followed immediately by infusion of rhTNF-α.
16187589|NCT01490047|Drug|Recombinant human TNF-α|Recombinant human TNF-α (Beromun) will be diluted in 250 mL of normal saline with albumin (2 mg/mL) to prevent adherence of the protein to the delivery apparatus. Infusion will be done over 60 minutes, preferably via central venous catheter, including PICC lines.
16187590|NCT01490034|Behavioral|Metabolic effects of consuming energy dense beverages|Consumption of energy dense beverages for 2 weeks and monitoring physiological responses
16187591|NCT01490034|Behavioral|energy dense solid food|Effects of consuming energy dense solid food for two weeks on physiological responses
16187592|NCT01490034|Behavioral|Energy dilute beverages|Effects of consuming energy dilute beverages for two weeks on physiological responses.
16187593|NCT01490034|Behavioral|Energy dilute solid food|Effects of consuming energy dilute solid food for two weeks on physiological responses
16187594|NCT01490021|Procedure|rTMS/Active TBS|A continuous Theta-Burst Stimulation (TBS) protocol will be applied over the left dorsolateral prefrontal cortex. Three stimuli at 50Hz, 80% of individual Motor Threshold will be repeated every 200ms for 40sec (Galea et al., 2010; Oberman and Pascual-Leone, 2009).
16187595|NCT01490021|Procedure|rTMS/Placebo TBS|rTMS/Placebo TBS
16187596|NCT01490008|Drug|Veregen|Patients in treatment arm 1 will apply Veregen® 15% ointment (approved commercial source in US) in a total of 750 mg/day for one week, corresponding to application of maximal about 106,9 mg catechins/d, thereof maximal 81 mg ECGg per day). Patients will be instructed to apply fix portions of 250 mg three times daily on the defined anogenital administration area.
16187597|NCT01490008|Other|Green Tea|"Healthy volunteers in treatment arm 2 will drink Lipton® Green Limone in a total of 1500 mL/d for one week, in portions of 500 mL three times daily after the meals"
16187598|NCT01489995|Drug|A (migalastat)|150 mg migalastat HCl in the fasting state (reference arm)
16187599|NCT01489995|Drug|B (migalastat)|150 mg migalastat HCl with simultaneous consumption of a glucose drink
16187600|NCT01489995|Drug|C (migalastat)|150 mg migalastat HCl 1 hour before consumption of a high fat meal
16187601|NCT01489995|Drug|D (migalastat)|150 mg migalastat HCl 1 hour before consumption of a light meal
16187602|NCT01489995|Drug|E (migalastat)|150 mg migalastat HCl 1 hour after consumption of a light meal
16187603|NCT01489982|Device|Light box (Litebook company)|Light therapy will be administered daily for a duration of 30 minutes, starting two hours (+/- 1 hour) prior to usual bedtime
16187604|NCT01489982|Behavioral|CBT and sleep hygiene|6 weekly sessions totalling 90 minutes
16187605|NCT01489982|Drug|Doxepin and Zopiclone|Zopiclone 3.75 mg at h.s., increasing to 7.5 mg after one week if insufficient clinical effects ( and no troublesome side effects) or Doxepin 5 mg at h.s. followed by increase up to 10 mg after the first week if insufficient clinical effect (and no troublesome side effects)
16187606|NCT01489982|Device|Light box ( Litebook company)|The intervention will be 30 minutes of light therapy, using red light below the threshold required to entrain light cycles
16187607|NCT01489969|Drug|Neu-P11|1 tablet daily 1-2 before bed time for 28 days of double blind treatment
16187608|NCT01489956|Biological|Immucothel Alone (Part A)|100 ug at day 0 (priming dose) and day 9(booster dose)
16187609|NCT01489956|Biological|Immucothel+Montanide (Part A)|100 ug SQ Immucothel plus Montanide at day 0 (priming dose) and day 9 (booster dose)
16187610|NCT01489956|Biological|Immucothel Alone or Immucothel+Montanide (Part B)|50 mg of native KLH on days 0-4 and 10-14 (total of 500 mg). Immunization on days 26 and 35.
16187611|NCT01489943|Drug|GSK1605786 500 mg|Subjects will receive 500 milligram (mg) (2 doses of 250 mg) GSK1605786 hard gelatin capsules twice daily orally on Days 5 to 14. GSK1605786 will be administered with 240 milliliter (mL) of water.
16187612|NCT01489943|Drug|Midazolam 3 mg|Subjects will receive 3 mg oral syrup of Midazolam once daily on Day 1 and Day 11. Midazolam will be administered with 240 mL of water.
16187613|NCT01489943|Drug|Pioglitazone 15 mg|Subjects will receive 15 mg tablet of pioglitazone orally once daily on Day 2 and Day 12. Pioglitazone will be administered with 240 mL of water.
16187614|NCT01489943|Drug|Omeprazole 40 mg|Subjects will receive 40 mg hard gelatin capsules of Omeprazole once daily on Days 3 and 13. Omeprazole will be administered with 240 mL of water.
16187615|NCT01489943|Drug|Rosuvastatin 10 mg|Subjects will receive 10 mg tablet of Rosuvastatin orally once daily on Days 4 and 14. Rosuvastatin will be administered with 240 mL of water.
16187616|NCT01489930|Behavioral|Endurance exercise|Participants will perform 8-weeks of endurance exercise training. Participants will train 5 days per week for 60 min at 65% of VO2 peak.
16187617|NCT01489930|Behavioral|Resistance exercise|Participants will perform 8-weeks of resistance exercise training. Participants will train 4 days per week for ~60 min. Two days will focus on lower body resistance training and two days will focus on upper body.
16187618|NCT01489930|Behavioral|Control/Combined training|Participants will perform 8-weeks of no exercise (control), followed by 8-weeks of combined endurance and resistance training. Participants will endurance train 5 days per week for 30 min at 65% of VO2 peak and resistance train 4 days per week for 30 min.
16187619|NCT01489917|Other|Patent hemostasis and heparin|Radial artery patency is verified. If not maintained, then a bolus of heparin 50 U/kg or a maximum of 5000 units is administered and the compression (TR band) is left in place for 2 hours.
16187620|NCT01489904|Biological|BOTULINUM NEUROTOXIN TYPE-A|Botulinum toxin type A / First infiltration: 25U in each salivary gland=100 U in Parotid and submandibular glands. 24 weeks after first infiltration is a Second infiltration with 50U Botulinum toxin type -A 25 U in each salivary gland only in parotid glands.
16187621|NCT01489891|Drug|Lidocaine|Applying of 5 puff controlled released (50 mg) transoral spray of lidocaine (10 mg=1 puff).
16187622|NCT01489891|Drug|Placebo|Applying of 5 puff controlled released (50 mg) transoral spray of placebo (excipients of trade mark of lidocaine ensuring the patient masking).
16187623|NCT01489865|Drug|ABT-888 and mFOLFOX-6|ABT-888 in escalating doses twice a day for Days 1-7 of each 14-day cycle Oxaliplatin 85 mg/M2 IV on Day 1 Leucovorin 400 mg/m2 IV on Day 1 5-FU 400 mg/m2 IV bolus followed by 2400 mg/m2 IV continuous infusion over 46 hours Days 1-3
16187624|NCT01489852|Drug|17beta-estradiol|Pretreatment with 17beta-estradiol (Provames®, Aventis, Paris, France) was administered daily (2 mg twice a day) during the cycle preceding the IVF/ICSI cycle, starting 7 days before the predicted onset of menses and administered up until to the following Thursday after the occurrence of menses.
16187625|NCT01489839|Other|Periodontal therapy|All subjects will have professional dental prophylaxis and periodontal therapy withheld for 12 months during the disease progression and monitoring phase. After 12 months, subjects with periodontal disease will receive periodontal therapy to consist of scaling and root planing, and periodontally healthy subjects will receive professional dental prophylaxis. Subjects with periodontal disease will also receive Supportive Periodontal Therapy at the 3- and 6-month post-therapy visits. Subjects showing periodontal disease progression greater than a predetermined threshold during the monitoring or maintenance phases of the study will be given rescue therapy consisting of placement of a local antibiotic at the site of disease progression.
16187626|NCT01489826|Drug|Dexanabinol|Patients will (initially) be given a slow intravenous (i.v.) infusion of Dexanabinol over 3 hours on Days 1, 8 and 15 of a three weekly (21 day) cycle.
16187627|NCT01489826|Other|Cremophor|Drug vehicle.
16187628|NCT01489813|Drug|Genistein|30 mg of genistein supplement by mouth three times daily (PO TID).
16187629|NCT01489813|Drug|Sugar pill|Sugar pills will be taken by mouth three times daily (PO TID).
16187630|NCT01489800|Behavioral|Clear liquid diet|clear liquid diet, the same for each arm, will be given 24 hours after extubation as the intervention in the experimental arm.
16187631|NCT01489787|Procedure|HIFU|"The shootings will concern the healthy liver to remove, distant to the important vascular structures and metastases. Two HIFU shootings will be made on each patient:
~One hurt on the surface starting from the Glisson capsule and extending to subjacent hepatic parenchyma.
~One hurt at given depth, at least 10 mm deeper than the hurt done on the surface NB: The shooting depth will determined for each patient at the beginning of the operation, considering preoperative exams (scans, etc.), size and location of the liver part to be resected and physical structure of the patient."
16187632|NCT01489787|Procedure|HIFU|The shootings will concern healthy liver to be resected, distant (step 1) then close (step 2) to the important vascular structures of the liver. Several shootings HIFU will be made on each patient (ideally 4 hurts, minimum 2 hurts)
16187633|NCT01489787|Procedure|HIFU|"Shootings will concern small metastases (≤ 20 mm) and peri lesional healthy liver. They will be juxtaposed on multiple plans in order to generate a large hurt containing the metastasis targeted and guaranteeing a sufficient safety margin in healthy liver.
~Several metastases can be treated in the same patient"
16187634|NCT01489774|Drug|Placebo|single and multiple dose
16187635|NCT01489774|Drug|CJ-12406|single and multiple dose
16187636|NCT01489761|Device|percutaneous coronary intervention|drug eluting stent implantation
16187637|NCT01489722|Drug|AZD1208|Daily oral doses of AZD1208 for 28 day cycles until progression or unacceptable toxicity develops. Starting dose will be 120 mg and will be escalated in successive cohorts until an MTD is established.
16187638|NCT01489709|Drug|Vesicare|oral
16187639|NCT01489696|Drug|mirabegron|oral
16187640|NCT01489696|Drug|tamsulosin|oral
16187641|NCT01489683|Drug|lidocaine|3 ml of 4% lidocaine was instilled to larynx and trachea
16187642|NCT01489683|Drug|normal saline|3 ml of normal saline was instilled to larynx and trachea before endotracheal intubation
16187750|NCT01488890|Biological|Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus|0.5 mL, Subcutaneous
16187643|NCT01489670|Drug|bimatoprost 0.01% ophthalmic solution|Patients with primary open-angle glaucoma or ocular hypertension treated with Lumigan® 0.01% in clinical practice.
16187644|NCT01489644|Drug|repaglinide|Subjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order
16187645|NCT01489644|Drug|metformin|Subjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order
16187646|NCT01489644|Drug|repaglinide and metformin combination tablet|Subjects will receive 850 mg metformin alone on a fasting state, 2 mg repaglinide alone on a fasting state, 2 mg repaglinide/850 mg metformin (NN4440 2/850) in the fasting state or 2 mg repaglinide/850 mg metformin (NN4440 2/850) immediately prior to a standardised high fat meal on 4 separate dosing visits in varying order
16187647|NCT01489631|Drug|naropin|ropivacaine 0,2%, 3x 50 ml during surgery
16187648|NCT01489631|Drug|marcaine|bupivacaine 0,125%
16187649|NCT01489631|Drug|sufentanil|sufentanil 1mcg/ml
16187650|NCT01489631|Drug|neurontin|gabapentin 600 mg pre-operative 3 dd 300 mg
16187651|NCT01489618|Biological|PPS|POLYSACCHARIDE ANTI- PNEUMOCOCCAL VACCINE
16187652|NCT01489618|Biological|PnCJ PPS|PRIMEBOOST CONJUGATED ANTI- PNEUMOCOCCAL VACCINE (Week 0) POLYSACCHARIDE ANTI- PNEUMOCOCCAL VACCINE (Week 4)
16187653|NCT01489605|Device|GlideScope Groove|Patients will be intubated using the GlideScope Groove device. (Verathon)
16187654|NCT01489605|Device|Control: Standard GlideScope|Patients will be intubated using the standard GlideScope. (Verathon)
16187655|NCT01489592|Drug|curcuma longa|oral administration of 6 grams of curcumin
16187656|NCT01489579|Behavioral|Telephone Counseling for Tobacco Cessation|"The patients in the Brief, Structured, Telephone (BST) counseling group will receive tobacco cessation counseling by a trained CPCRS pharmacist as part of their routine CPCRS care. The counseling will not be scripted, but must contain three key components (recommendation to quit, discussion/recommendation of tobacco cessation medications, and discussion/recommendation of tobacco cessation methods/strategies (Appendix C). These are the same items measured by the National Committee for Quality Assurance (NCQA) for Healthcare Effectiveness and Data Information Set (HEDIS) reporting. A standard KPCO document will be mailed to the patients following the BST counseling containing information about available resources (Ready to quit patient handout)"
16187657|NCT01489579|Behavioral|Usual Care|Pharmacists randomized to Usual Care will continue to provide interventions/procedures they normally would according to usual care practices. These interventions include any of the following: no action, mailed information on the resources available to help aid tobacco cessation, telephone counseling, and/or assistance in getting tobacco cessation medications. Pharmacists who are randomized to Usual Care will be asked to continue their current approach for tobacco cessation recommendations
16187658|NCT01489566|Drug|Tyroserleutide for injection ,chemotherapy(mitomycin, and Fluorouracil )|mitomycin(10mg)+Fluorouracil(1.0g),through the chemoradiative pump,every cycle,5-30 minites; Tyroserleutide for injection(30mg) ,through the micro infusion pump,every cycle,3-5 days
16187659|NCT01489566|Drug|the placebo ,chemotherapy(mitomycin, and Fluorouracil )|mitomycin(10mg)+Fluorouracil(1.0g),through the chemoradiative pump,every cycle,5-30 minites; the placebo(30mg) ,through the micro infusion pump,every cycle,3-5 days
16187660|NCT01489540|Device|laser Doppler imager (Moor)|The laser Doppler imager measures the blood flow of the skin/burn
16187661|NCT01489527|Biological|Gardasil Vaccine|The study vaccine was blindly administered as supplied on Day 1, Month 2, and Month 6. All vaccines were injected intramuscularly into the deltoid muscle by a member of the clinical staff.
16187662|NCT01489527|Other|Placebo|The study vaccine was blindly administered as supplied on Day 1, Month 2, and Month 6. All vaccines were injected intramuscularly into the deltoid muscle by a member of the clinical staff.
16187663|NCT01489514|Other|Epicutaneous skin prick testing|"Epicutaneous skin prick testing will be performed utilizing the following extracts:
~Histamine control purchased from Greer.
~Saline control purchased from Greer.
~Standard Peanut Extract purchased from Greer.
~Sterile extract prepared from Trypsin and Chymotrypsin treated peanuts. This is prepared by North Carolina A & T.
~Sterile extract prepared from roasted & blanched but untreated peanuts. This is prepared by North Carolina A & T.
~Sterile extract prepared from peanuts (no blanching, no enzyme). This is prepared by North Carolina A & T. This is not classified as a drug and is
~Sterile extract containing peanuts treated with 0.2% inactivated a-chymotrypsin and trypsin as an enzyme negative control.
~Sterile extracts containing peanuts that have been treated with alcalase"
16187664|NCT01489501|Procedure|Surgical transplantation of CAOMECS to the ocular surface|Surgical transplantation of oral mucosa derived CAOMECS sheet onto eye cornea.
16187665|NCT01489488|Drug|Riociguat (BAY63-2521)|Single oral dose of 2.4 milligram (mg) riociguat (BAY63-2521) as pediatric high-concentration suspension (0.15 mg per milliliter [mg/mL], i.e. 16 mL) under fasting conditions
16187666|NCT01489488|Drug|Riociguat (BAY63-2521)|Single oral dose of 2.4 mg riociguat as pediatric high-concentration suspension (0.15 mg/mL, i.e. 16 mL) under fed conditions
16187667|NCT01489488|Drug|Riociguat (BAY63-2521)|Single oral dose of 0.3 mg riociguat as pediatric high-concentration suspension (0.15 mg/mL, i.e. 2 mL) under fasting conditions
16187668|NCT01489488|Drug|Riociguat (BAY63-2521)|Single oral dose of 0.15 mg riociguat as pediatric low-concentration suspension (0.03 mg/mL, i.e. 5 mL) under fasting conditions
16187669|NCT01489488|Drug|Riociguat (BAY63-2521)|Single oral dose of riociguat immediate release (IR) tablet 1 mg under fasting conditions
16187670|NCT01489462|Behavioral|High Intensity Strength Training|The strength-training intervention will consist of 5-min warm-up, 40-min training, and 15-min cool-down. The 60-min sessions will be conducted 3 times/wk for 18 months. Every 2 weeks the load lifted will be adjusted so that the participants in this group are lifting 3 sets of each exercise at 75-90% of 1RM.
16187671|NCT01489462|Behavioral|Low Intensity Strength Training|The strength-training intervention will consist of 5-min warm-up, 40-min training, and 15-min cool-down. The 60-min sessions will be conducted 3 times/wk for 18 months. Every 2 weeks the load lifted will be adjusted so that the participants are lifting 3 sets of 15 repetitions at 30-40% of 1RM.
16187672|NCT01489462|Behavioral|Attention Control|Participants in the control group will attend 60-min organized workshops 2 times/month for the first 6 months and then 1 time/month for months 7-18. Over the 18 months interactive presentations will cover such topics as foot care, nutrition, managing medication, and sleep practices, and experts will give wide-ranging lectures.
16187673|NCT01489449|Device|Stent|bare metal stent implantation, any bare metal stent is allowed from different companies
16187674|NCT01489449|Device|SeQuent(R) Please coated balloon|Angioplasty with Drug coated balloon (DCB)
16187675|NCT01489436|Procedure|Single-port cholecystectomy|In brief, a flexible, multi-sleeve 15-mm trocar designed specifically for single-port cholecystectomy will be inserted at the umbilicus via a 15-mm single incision. This trocar permits simultaneous introduction of multiple instruments, including a 5-mm flexible-tip laparoscope. Standard 5-mm instruments will be used for retraction and dissection. An additional 2-mm grasping device may be introduced in the right upper quadrant for retraction if necessary. A 5-mm laparoscopic clip applier will be introduced through the periumbilical trocar to ligate the cystic artery and the cystic duct. The gallbladder will be removed through the umbilical port.
16187676|NCT01489436|Procedure|Four-port laparoscopic cholecystectomy|The control procedure for the research practicum is a four-trocar laparoscopic cholecystectomy, the current gold-standard operation. This approach utilizes a 10-mm trocar placed at the umbilicus via a 15-mm incision and three separate subcostal 5-mm trocars placed via separate 5-mm incisions. The gallbladder will be removed through the umbilical trocar site. On occasion, this incision needs to be enlarged to accommodate removal of the gallbladder.
16187677|NCT01489423|Genetic|RNA analysis|
16187678|NCT01489423|Genetic|in situ hybridization|
16187679|NCT01489423|Genetic|polymerase chain reaction|
16187680|NCT01489423|Other|enzyme-linked immunosorbent assay|
16187681|NCT01489423|Other|flow cytometry|
16187682|NCT01489423|Other|immunohistochemistry staining method|
16187683|NCT01489423|Other|laboratory biomarker analysis|
16187684|NCT01489410|Drug|Drug-Eluting Beads (DEB) with Doxorubicin|One treatment of Drug-Eluting Beads (DEB) with Doxorubicin administered to the liver through a groin puncture site and delivered through the vessels that feed the liver (per standard of care).
16187685|NCT01489410|Drug|Lipiodol Ethanol Mixture|One treatment of Lipiodol Ethanol Mixture (LEM) is administered to the liver through a groin puncture site and delivered through the vessels that feed the liver (per standard of care).
16187686|NCT01489397|Device|Confocol laser endomicroscopy|Confocal laser endomicroscopy was applied at suspected lesion and normal mucosa followed by biopsy for pathology.
16187687|NCT01489371|Other|Laboratory Biomarker Analysis|Correlative studies
16187688|NCT01489371|Biological|PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1|Given IP
16187689|NCT01489371|Drug|Pegylated Liposomal Doxorubicin Hydrochloride|Given IV
16187690|NCT01489358|Biological|VRC-CHKVLP059-00-VP|VRC-CHKVLP059-00-VP is a VLP vaccine that consists of the E1, E2 and capsid proteins of the Chikungunya Virus
16187691|NCT01489345|Drug|ONO-2952|30 mg to 100 mg QD at a multiple dose, and 21 days duration
16187692|NCT01489345|Drug|ONO-2952 Matching Placebo|30 mg to 100 mg QD at a multiple dose, and 21 days duration
16187693|NCT01489332|Drug|intensified preoperative chemotherapy|"capecitabine 1250 mg/m² p.o. twice daily for 14 consecutive days, 7 days rest for one cycle; radiotherapy: 50.4 Gy to the pelvis (25x 1.8 Gy on days 1-33, excluding weekends) plus 5.4 Gy on days 36-38 as a boost to the primary tumour (3 fractions of 1.8 Gy).Three- dimensional CT planing and a four field box technique with high energy photons (15 MV) will be used. capecitabine 825 mg/m² p.o. twice daily on days 1-38 (including weekends), One week after completion of radiochemotherapy patients receive 2 cycles of capecitabine based chemotherapy (1250 mg/m² p.o. twice daily for 14 consecutive days every three weeks).
~Radical surgery (TME): to be undertaken 8 weeks following completion of chemoradiation Postoperative treatment:capecitabine 1250 mg/m² p.o. twice daily for 14 consecutive days every three weeks; 3 cycles (R0 beginning 6-8 weeks after surgery"
16187694|NCT01489319|Drug|Salsalate|4 out of 10 subjects will receive salsalate 2.0 gm twice a day for 12 weeks; 4 out of 10 subjects will receive PCE 200 mg containing 20% resveratrol twice a day for 12 weeks.
16187695|NCT01489319|Drug|Salsalate|4 out of the 10 subjects will receive salsalate 2.0 gm twice a day for 12 weeks; 4 out of 10 subjects will receive PCE 200 mg containing 20% resveratrol twice a day for 12 weeks.
16187696|NCT01489306|Drug|MDT-637|Inhaled doses of MDT-637 over a 10 day period
16187697|NCT01489306|Drug|MDT-637|Inhaled doses of MDT-637 over a 10 day period
16187698|NCT01489267|Other|stem cell transplantation|The patients accepted 4 times stem cell transplantations through lumbar puncture, the time is 3-5days between two treatments and the dose is about 2 ml(including 1×10'7 cells).
16187699|NCT01489254|Drug|Glatiramer Acetate (GTR)|Glatiramer Acetate (GTR) 20 mg daily, for 9 months (Part 1) followed by additional 15 month treatment period (Part 2)
16187700|NCT01489254|Drug|Glatiramer Acetate (Copaxone®)|Glatiramer Acetate (Copaxone), 20 mg daily, for 9 months followed by additional 15 month GTR 20 mg daily treatment period (Part 2)
16187701|NCT01489254|Drug|Placebo|Placebo (daily) for 9 months followed by additional 15 month GTR 20 mg daily treatment period (Part 2)
16187702|NCT01489241|Procedure|Telemonitoring|Within 24 hours after patient's discharge, the telemedicine equipment is installed at the patient's home and patients are trained in the use of the equipment. Patients are followed by a dedicated telehealth centre. Patients at home are asked to fill out each morning the CAT questionnaire and to record extra use of COPD relief medications. Patients in stable conditions perform telespirometry and teleoximetry at 4 and 12 weeks. When a clinical worsening is detected (increase in CAT score by 5 points or higher on two consecutive days) the patient is contacted and asked to perform ad hoc telespirometry and teleoximetry and to send the data to the telehealth centre.
16187703|NCT01489228|Drug|E1224|100 mg tablets
16187704|NCT01489228|Drug|Benznidazole|100mg tablets
16187705|NCT01489228|Drug|Placebo|tablets
16187706|NCT01489215|Behavioral|"presence"|"constant presence of the parent in the child's room throughout the night during the first week of the intervention. In addition to sleeping near the child's crib, the parents repeat the same routines as in the checking method if the child is actively protesting or crying."
16187751|NCT01488890|Biological|Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus|0.5 mL, Subcutaneous
16187752|NCT01488890|Biological|Yellow Fever|0.5 mL, Subcutaneous
16187707|NCT01489215|Behavioral|"checking"|putting the child into the crib at bedtime and leaving the room with repeated quick visits every 5 minutes if the child is actively protesting or crying, providing brief reassurance, helping the child to resume a sleeping position.
16187708|NCT01489202|Device|platinum chromium everolimus-eluting stent|An everolimus-eluting stent with a platinum chromium platform
16187709|NCT01489202|Device|cobalt chromium everolimus-eluting stent|An everolimus-eluting stent with cobalt chromium platform
16187713|NCT01489176|Drug|Regadenoson; Optison|A one-time intravenous bolus of Regadenoson 400 mcg; continuous intravenous infusion of Optison of 2-4 mL/minute.
16187714|NCT01489163|Behavioral|Lifestyle Counseling|The Phase I intervention will be delivered through 1 individual in-person session and 3 individual telephone counseling contacts. The Phase II intervention begins at 6-week postpartum and will be delivered through 3 individual in-person sessions and 13 telephone counseling contacts over a period of 6 months. The maintenance phase (Phase III) will begin at 8 months postpartum.
16187715|NCT01489137|Drug|remifentanil|"According to previous patient's response, the investigators will allocate the effect site concentration of remifentanil of next patient during head fixation. And, For this allocation of dose of remifentanil the investigators use biased coin design up-and-down method.
~For the first patient, the dose of remifentanil would be fixed at 5.5ng/ml which we predict as EC90. And, step size of dose is 0.5ng/ml."
16187716|NCT01489124|Drug|Imipenem|0.5 g of imipenem every 6 hrs administrated by 0.5-hr infusion for 3 days
16187717|NCT01489124|Drug|Imipenem|0.5 g of imipenem every 6 hrs administrated by 2-hr infusion for 3 days
16187718|NCT01489124|Drug|Imipenem|1 g of imipenem every 6 hrs administrated by 2-hr infusion for 3 days
16187719|NCT01489111|Drug|turoctocog alfa pegol|Bleeding preventive treatment administered i.v. before, during and after surgery. Individually adjusted doses.
16187720|NCT01489072|Drug|Remifentanil|Bolus dose of intravenous remifentanil 0.25 mcg/kg given once before emergence of general anesthesia
16187721|NCT01489072|Drug|Remifentanil|Bolus dose of intravenous remifentanil 0.5 mcg/kg given once before emergence of general anesthesia
16187722|NCT01489059|Biological|BMS-982470 (recombinant interleukin-21)|Solution, Intravenous, 10,30,50 μg/kg, daily for 5 days every 3 weeks (daily x 5), 16-20 weeks depending on response
16187723|NCT01489059|Biological|BMS-982470 (recombinant interleukin-21)|Solution, Intravenous, 30,100,150 μg/kg, weekly, 16-20 weeks depending on response
16187724|NCT01489059|Biological|BMS-982470 (recombinant interleukin-21)|Solution, Intravenous, Maximum tolerated dose from Part 1, daily for 5 days every 3 weeks (daily x 5), 12-16 weeks depending on response
16187725|NCT01489059|Biological|BMS-982470 (recombinant interleukin-21)|Solution, Intravenous, Maximum tolerated dose from Part 1, Weekly, 12-16 weeks depending on response
16187726|NCT01489059|Biological|Ipilimumab|Solution, Intravenous, 1,3,10 mg/kg, every 3 weeks, 16-20 weeks depending on response
16187727|NCT01489059|Biological|Ipilimumab|Solution, Intravenous, Maximum tolerated dose from Part 1, every 3 weeks, 12-16 weeks depending on response
16187728|NCT01489059|Biological|Ipilimumab|Solution, Intravenous, 3mg/kg, Every 3 weeks, 12-16 weeks depending on response
16187729|NCT01489046|Drug|BMS-986001|Capsules, Oral, 100 mg, Once daily, At least 48 weeks
16187730|NCT01489046|Drug|BMS-986001|Capsules, Oral, 200 mg, Once daily, At least 48 weeks
16187731|NCT01489046|Drug|BMS-986001|Capsules, Oral, 400 mg, Once daily, At least 48 weeks
16187732|NCT01489046|Drug|Placebo matching with BMS-986001|Capsules, Oral, 0 mg, Once daily, At least 48 weeks
16187733|NCT01489046|Drug|Efavirenz|Tablets, Oral, 600 mg, Once daily, Entire Treatment Phase
16187734|NCT01489046|Drug|Lamivudine|Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
16187735|NCT01489046|Drug|Tenofovir|Tablets, Oral, 300 mg, Once daily, Entire Treatment Phase
16187736|NCT01489033|Biological|Subcutaneous immunotherapy with Phleum pratense pollen extract|Increasing doses up to a maximum dose of 500 TSU
16187737|NCT01489020|Biological|subcutaneous immunotherapy with DPT extract|Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)
16187738|NCT01489020|Biological|Subcutaneous depot placebo|Increasing doses of subcutaneous depot placebo in three different scales
16187739|NCT01488994|Biological|BAX326|All participants underwent a pharmacokinetic evaluation with BAX326 (recombinant Factor IX) followed by twice weekly prophylactic treatment for 6 months or for at least 50 exposure days, whichever occurred last.
16187740|NCT01488981|Other|Upper Extremity Therapy without stimulation|Two 12 week phases of occupational therapy without electrical stimulation.
16187741|NCT01488981|Device|Upper Extremity Therapy with stimulation from the Radiofrequency Microstimulator (RFM) System (Alfred Mann Foundation, Santa Clarita, CA)|Two 12 week phases of occupational therapy that incorporates electrical stimulation from the RFM System.
16187742|NCT01488968|Radiation|Standard Radiation Treatment|39 radiation treatments
16187743|NCT01488968|Radiation|Hypofractionated radiation treatment|25 radiation treatments
16187744|NCT01488955|Drug|Ibuprofen|400 mg oral once a day from day 0 for 3 days
16187745|NCT01488955|Drug|Fosfomycin-Trometamol|8 g granulate with 3 g Fosfomycin-Trometamol oral once at day 0, placebo to Ibuprofen once a day oral from day 0 for 3 days
16187746|NCT01488942|Other|monetary reinforcer|The protocol will follow an escalating schedule of reinforcements tied to clinic visit attendance for the first 24 weeks, after which the reinforcers will take the form of an escalating variable reinforcement schedule in the form of fishbowl prize draws linked to maintenance of suppressed viral load for the remainder of the 52-week study period. In addition, a reset function will be incorporated by which the reinforcer will be rolled back to an initial lower value if clinic visits or viral load targets are not met. This will be rapidly scaled up again once targets are met.
16187747|NCT01488929|Drug|TC-5619|
16187748|NCT01488929|Drug|Placebo|
16187749|NCT01488890|Biological|Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus|0.5 mL, Subcutaneous
16187758|NCT01488864|Behavioral|Applied Relaxation (AR)|"AR is a technique influenced on cognitive behavioral therapy using coping mechanism and conditioning. AR focuses on muscle relaxation, where breathing is used for the conditioning of the relaxation. AR implies participation in 10 group sessions during a period of 12 weeks. A therapist will see the women assigned to AR in a group consisted of 6-8 women. The weekly sessions will last for 60 minutes each and are based on a scheme from Öst. The women will be told to practice each component daily.
~During the first session a lecture about menopause and about theories of the mechanisms behind hot flashes will be given.
~The aim of applying AR in view of coping with vasomotor symptoms will be discussed. The group is given a rationale of applying AR as a coping technique for handling sudden unanticipated symptoms by quick calming down, and thus gaining control over the situation."
16187759|NCT01488838|Drug|Cisplatin: 40 mg/m2 weekly during radiation|Cisplatin: 40 mg/m2 weekly during radiation for 7 doses
16187760|NCT01488838|Radiation|Radiation: 60-66 Gy in 2 Gy daily fractions|Radiation: 60-66 Gy in 2 Gy daily fractions
16187761|NCT01488825|Behavioral|Yoga Therapy|Therapeutically oriented style of yoga originated from Pancha Kosha philosophy of Vedanta was used throughout the trial. All the sessions emphasized on postures, breathing practices with the specific focus on relaxation, combination of chants and meditation. Once a week, Kunjal and Jalaneti (cleansing practices) were practiced in guidance of therapist. They all were instructed to eat light and rest on Kriya days.
16187762|NCT01488799|Behavioral|Motivational Interviewing and Cognitive Behavioural Therapy|Participants with a diagnosis of severe Generalized Anxiety Disorder will be randomly assigned to receive either 4 weekly sessions of MI followed by 11 weekly sessions of CBT (MI-CBT arm) or 15 weekly sessions of CBT (CBT alone arm). Both groups will also receive 2 follow-up CBT treatment sessions at 1 and 3 months post-treatment. In order to increase generalizability to clinical practice, in the CBT phase for the MI-CBT arm, therapists will shift to MI in the presence of empirically derived markers of resistance and shift back to CBT when resistance has diminished. In the CBT alone arm therapists will respond to resistance using manualized recommendations derived from leading CBT theorists for the management of resistance.
16187763|NCT01488786|Device|BrainPort Vision Device|2-3 days of training (10 hours) followed by minimum in-home use 300 minutes per month for 12 months.
16187764|NCT01488773|Drug|first prescription of montelukast|The index event (intervention) was defined as the first prescription for montekuast (leukotriene receptor antagonist) occurring in patient's medical history that established a 12-month pre-index and three consecutive 12-month post-index periods.
16187765|NCT01488773|Drug|first prescription of salmeterol|The index event (intervention) was defined as the first prescription for salmeterol (long-acting β2-agonist) occurring in patient's medical history that established a 12-month pre-index and three consecutive 12-month post-index periods.
16187766|NCT01488747|Dietary Supplement|Coromega Omega-3 Squeeze|660 mg EPA, 434 mg DHA
16187767|NCT01488747|Dietary Supplement|Coromega Nectar|660 mg EPA, 436 mg DHA
16187768|NCT01488747|Dietary Supplement|Barleans Swirl|660 mg EPA, 660 mg DHA
16187769|NCT01488747|Dietary Supplement|Nordic Omega-3 Softgel|660 mg EPA, 440 mg DHA
16187770|NCT01488734|Dietary Supplement|Mushroom with 600 IU vitamin D2|Subjects in this group will eat daily meals containing mushrooms fortified with 600 IU of Vitamin D2. These subjects will also take one placebo tablet per day.
16187771|NCT01488734|Dietary Supplement|Mushroom with 4000 IU Vitamin D2|Subjects in this group will eat daily meals containing mushrooms fortified with 4000 IU of Vitamin D2. These subjects will also take one placebo tablet per day.
16187772|NCT01488734|Dietary Supplement|600 IU Vitamin D3 and untreated mushroom|Subjects in this group will take one commercially available tablet of 600 IU of Vitamin D3. These subjects will also eat one meal per day with untreated (inactive) mushrooms.
16187773|NCT01488734|Dietary Supplement|4000 IU Vitamin D3 and untreated mushroom|Subjects in this group will take one commercially available tablet of 4000 IU of Vitamin D3. These subjects will also eat one meal per day with untreated (inactive) mushrooms.
16187774|NCT01488734|Drug|Placebo|Placebo for the fortified mushroom arms
16187775|NCT01488708|Drug|LY2127399|120 mg LY2127399 administered via subcutaneous (SC) injection for 216 weeks Participants randomized to active treatment in the core studies will remain on the same active dose. In order to ensure that the original randomization arm from the preceding core studies is not unblinded, the first dose in BCDX will be blinded, with all participants receiving 2 injections of blinded study drug.
16187776|NCT01488708|Drug|Placebo|Placebo administered via SC injection at first dose to maintain blinding of previous study treatment.
16187777|NCT01488695|Device|GlideScope Groove|GlideScope Groove
16187778|NCT01488695|Device|Control: Macintosh blade|Control: Patients will be intubated using the Macintosh blade
16187779|NCT01488682|Procedure|Neck dissection with Harmonic scalpel|The Harmonic Focus® Curved Shears (Ethicon Endo-Surgery, Cincinnati, OH) was used for vascular control of the surgery regardless of vessel diameter, except when hand-tied or suture ligation was needed for IJV ligation or in case bleeding was not controlled with electrocoagulation
16187780|NCT01488682|Procedure|neck dissection with conventional hand-tie ligation|electrocautery was used to control the small vessels and conventional hand-tied ligation was used for large sized arterial, venous, or lymphatic vessels
16187781|NCT01488669|Procedure|robot assisted neck dissection via retroauricular approach|A modified face lift or retroauricular incision is made and subplatysmal skin flap is elevated.The marginal mandibular branch of the facial nerve and spinal accessory nerve is identified and lateral part of level II and III is dissected under direct vision using conventional technique. Then, the robotic arms are inserted and the remaining fibrofatty tissue of level I,II,III are dissected under 3D vision.
16187782|NCT01488669|Procedure|Conventional neck dissection|A transverse skin incision from the mastoid tip to the midline 2 finger below the mandible is made and subplatysmal skin flap is elevated. The fibrofatty tissue of level I,II,III is dissected while preserving the marginal branch of the facial nerve and the spinal accessory nerve. The vessels are ligated using the conventional tie technique and the Harmonic scalpel.
16187783|NCT01488656|Dietary Supplement|Placebo|7-pill placebo dietary packed visually identical to active dietary supplement
16187814|NCT01488383|Drug|Sodium saccharin|Volunteers will take one capsule of saccharin 250mg (one day) and then, corresponding measurements will be performed
16187815|NCT01488370|Device|Endotracheal intubation|Endotracheal intubation
16191842|NCT01458197|Drug|Placebo|Capsule, qd, 12 weeks
16187784|NCT01488656|Dietary Supplement|Antioxidant, anti-inflammatory dietary supplement|A combination of dietary supplements including: β-carotene, vitamin C, vitamin D3, vitamin E, vitamin K, thiamin, riboflavin, niacin, vitamin B6, folate, vitamin B12, biotin, pantothenic acid, calcium, iodine, magnesium, zinc, selenium, copper, manganese, chromium, molybdenum, boron, silicon, vanadium, eicosapentaenoic acid, docosahexaenoic acid, olive extract, mixed tocopherols, bioflavonoids, inositol, choline, N-acetyl L-cysteine, bromelain, coenzyme Q10, turmeric extract, lutein, lycopene, broccoli concentrate, grape seed extract
16187785|NCT01488630|Other|STaRS|The intervention entails testing an automated substance abuse treatment referral system (STaRS) to be implemented in primary care practices through electronic health record systems to improve 1) referral rates to specialty care providers, 2) patient treatment initiation with the specialty care providers, and 3) revenues to the practices.
16187786|NCT01488604|Device|Polymeric Nasal Spray|Experimental nasal spray
16187787|NCT01488604|Device|Sham Nasal Spray|Sham nasal spray
16187788|NCT01488578|Drug|Tolterodine tartrate|Detrusitol Capsule 2mg and 4mg, depending on the Investigator prescription.Frequency and duration are according to Package Insert as follows.
16187789|NCT01488565|Drug|Azacitidine and eltrombopag|Standard: azacitidine D1-5, 8&9, until loss of clinical benefit. Experimental: eltrombopag at a dose ranging from 50-300mg for 6 months, continuing only in those deriving clinical benefit.
16187790|NCT01488552|Drug|Gemcitabine|1000 mg/m2 weekly on days 1,8, and 15 in a 28 day cycle. Part A: nab-paclitaxel/Gem for 6 cycles, followed by FOLFIRINOX for 6 cycles (31 patients); Part B: Alternate nab-paclitaxel/Gem with mFOLFIRI every 2 months for up to 1 year or 6 cycles of each regimen (30 patients).
16187791|NCT01488552|Drug|nab-paclitaxel|125 mg/m2 on days 1,8, and 15 of a 28 day cycle Part A: nab-paclitaxel/Gem for 6 cycles, followed by FOLFIRINOX for 6 cycles (31 patients); Part B: Alternate nab-paclitaxel/Gem with mFOLFIRI every 2 months for up to 1 year or 6 cycles of each regimen (30 patients).
16187792|NCT01488552|Drug|FOLFIRINOX|"The combination below will be given on days 1 and 15 of a 28 day cycle; 5-Fluorouracil 2400 mg/m2 with a 46-hour continuous IV infusion; Leucovorin 400 mg/m2 over a 2 hour IV infusion;
~Oxaliplatin 85 mg/m2 as a 2 hour IV infusion; Irinotecan 180 mg/m2 over a 90 minute IV infusion Part A: nab-paclitaxel/Gem for 6 cycles, followed by FOLFIRINOX for 6 cycles (31 patients); Part B: Alternate nab-paclitaxel/Gem with mFOLFIRI every 2 months for up to 1 year or 6 cycles of each regimen (30 patients)."
16187793|NCT01488552|Genetic|Immunohistochemistry (IHC) Analysis|Immunohistochemistry (IHC) Analysis will be performed on a fresh tissue biopsy of the tumor after chemotherapy has been administered. A targeted-based regimen will be determined from the results of the IHC analysis for the next therapy given to the patient in the maintenance phase of the study.
16187794|NCT01488552|Drug|Metformin|Metformin 500 mg daily as a 24 hour extended release tablet will also be given as part of the maintenance phase of this study.
16187795|NCT01488552|Drug|mFOLFIRI|5-FU IV infusion, 2400 mg/m2 46h continuous infusion (no bolus 5-FU) treatments per month equaling 1 cycle Leucovorin 400 mg/m2 dl (over a 2 hour IV infusion) Irinotecan 180 mg/m2 dl (over a 90 minute IV infusion) Part A: nab-paclitaxel/Gem for 6 cycles, followed by FOLFIRINOX for 6 cycles (31 patients); Part B: Alternate nab-paclitaxel/Gem with mFOLFIRI every 2 months for up to 1 year or 6 cycles of each regimen (30 patients).
16187796|NCT01488539|Behavioral|STAIR/NT treatment|STAIR/NT is a two module, sequential treatment in which the first module emphasizes present-focused skills training in affective an interpersonal regulation (STAIR) for day-to-day life difficulties and the second module incorporates past-focused work on the processing of the trauma, using narrative therapy (NT). STAIR/NT is a cognitive behavioral treatment that can be flexibly applied allowing treatment tailored to the needs of the individual patient; may be as brief as 16 sessions and as long as 24.
16187797|NCT01488539|Behavioral|Treatment as Usual (TAU)|The Treatment as Usual intervention content varies from site to site and involve some combination of psychotherapy and pharmacotherapy. Treatment duration varies across sites and ranges from 30 to 45 sessions.
16187798|NCT01488526|Drug|TDF treatment|About 100 mothers treated with tenofovir from 30-32 weeks of pregnancy to the week 4 of postpartum, then observed to the end of the study at post-partum week 28, paired infants received standard HBV prophylaxis.
16187799|NCT01488513|Drug|sphingosine kinase-2 inhibitor ABC294640|Given PO Starting dose of ABC294640 250 mg once on day on Days 1-28 of each 28-day cycle. Subsequent cohort doses (if reached) are as follows: 250 BID, 500 BID, 750 BID, 1,000 BID, 1,500 BID, 2,000 BID, 2,500 BID
16187800|NCT01488500|Other|Bronchoscopy|24 hours after exposure, a bronchoscopy will be performed to allow analysis of cells and inflammatory markers in bronchial wash, bronchioalveolar lavage and lung biopsies.
16187801|NCT01488487|Drug|Everolimus|Everolimus 7.5 mg administered daily for 28 days per cycle until disease progression or unacceptable toxicity.
16187802|NCT01488487|Drug|Pasireotide|Monthly (every 28 days) intramuscular injection of long-acting pasireotide (pasireotide LAR 60 mg) repeated on day 1 of every 28 day cycle until disease progression or unacceptable toxicity.
16187803|NCT01488474|Procedure|peripheral nerve stimulation|defining the minimal current threshold for distal motor response
16187804|NCT01488461|Genetic|blood sample|Blood sample will be analysed in order to check presence or not of mutation in ABC7, SLC9A6, GPR56, ATCAY.
16187805|NCT01488448|Drug|3% sodium chloride|4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge
16187806|NCT01488448|Drug|0.9% sodium chloride|4 milliliters delivered via nebulizer with 5 Liters O2 flow every 4 hours until discharge
16187807|NCT01488435|Dietary Supplement|Cow's milk|Powdered whole cow's milk
16187808|NCT01488435|Dietary Supplement|Follow-On Formula|Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide
16187809|NCT01488422|Behavioral|Stress Reduction|We are comparing 2 well-studied approaches to stress reduction. All participants will receive stress reduction instructions that have already been proven to effectively reduce stress. Our goal is to compare the neural mechanisms associated with both approaches.
16187810|NCT01488409|Drug|Acipimox|250 mg by mouth (PO) three times daily
16187811|NCT01488409|Drug|Placebo|0 mg by mouth (PO) three times daily
16187812|NCT01488396|Drug|0.05%cyclosporin eye drop|use twice daily for 6 months
16187813|NCT01488383|Drug|Purified extract of Rebaudina Stevia-Stevioside|volunteers will take only one capsule of stevioside (one day), and then corresponding measurements will be performed.
16191843|NCT01458197|Drug|Tarafenacin 0.4 mg|Capsule, qd, 12 weeks
16187816|NCT01488344|Drug|triple kinase inhibitor BIBF1120|triple kinase inhibitor BIBF1120 is given in addition to low-dose cytarabine
16187817|NCT01488318|Drug|Cetuximab|Cetuximab 250 mg/m2 IV weekly after loading dose 400 mg/m2 on cycle 1, day 1
16187818|NCT01488318|Drug|Dasatinib|Dasatinib 150 mg po
16187819|NCT01488305|Dietary Supplement|MNP (micro-nutrient powders)|MNP is added to explore the additional value of MNP in existing AAMA program
16187820|NCT01488305|Other|AAMA project activities (HFP and IYCF BCC)|This is the existing AAMA program
16187821|NCT01488292|Behavioral|RECAP social skills and reading program|weekly individual and group sessions
16187822|NCT01488279|Drug|Dexamethasone 2.5 mg and Sitagliptin 100 mg|Participants received Dexamethasone 2.5mg plus Sitaliptin 100mg daily for 8 days
16187823|NCT01488279|Drug|Dexamethasone 2.5 mg and placebo tablet|Participants rececived Dexamethasone 2.5 mg plus placebo tablet daily for 8 days
16187824|NCT01488266|Drug|Aripiprazole|patients who are randomly assigned to adjunctive aripiprazole are treated with a starting dose of 2.5 (or 5) mg/day of aripiprazole, which can be increased weekly in 2.5~5mg/day increments to a maximum dose of 15 mg/day based on assessment of tolerability and clinical response. Doses can be decreased at any visit, based on tolerability; They continue to receive the same fixed-dose of the previously used antidepressant throughout the study period when patient is assigned to aripiprazole augmentation group.
16187825|NCT01488266|Drug|switching to different class of antidepressant|Patients randomly assigned to switching to different antidepressant have to discontinue the previously used antidepressant and receive different antidepressant within flexible therapeutic doses as indication label information (as based on clinicians' preference and experience). Dose increase is permitted until the first 2 weeks of the study.
16187826|NCT01488253|Drug|Sirolimus|Sirolimus will be administered as a 6-mg oral loading dose beginning on day -1, followed by 3 mg per day orally in a single morning dose with a target trough level of 5-12 ng/mL. Trough levels will be measured once a week. Sirolimus will be gradually tapered beginning at day +100, and eliminated by day +180, unless the patient required continued treatment for GVHD or experienced toxicity related to drugs.
16187827|NCT01488253|Drug|Tacrolimus|Tacrolimus will be administered beginning on day -1 at 0.05 mg/kg intravenously by continuous infusion every 24 hours, with a target serum level of 5 to 10 ng/mL. Tacrolimus dosing is converted to oral capsules prior to discharge. Trough levels will be measured once a week. Tacrolimus will be gradually tapered beginning at day +100, and eliminated by day +180, unless the patient required continued treatment for GVHD or experienced toxicity related to drugs.
16187828|NCT01488240|Procedure|pulsed dye laser|laser energy
16187829|NCT01488227|Dietary Supplement|Vitamin D|4000 IU of Vitamin D daily for 6 months
16187830|NCT01488227|Dietary Supplement|Placebo|Acts as a control for the Vitamin D intervention
16187831|NCT01488214|Other|Magnetic resonance Imaging|Magnetic resonance Imaging Assessment
16187832|NCT01488201|Drug|Placebo|
16187833|NCT01488201|Drug|KHK4827|
16187834|NCT01488188|Biological|Influenza vaccine|Administration of 1 dose (0.2 ml) by nasal route
16187835|NCT01488188|Biological|Influenza vaccine|Administration of 1 dose (0.2 ml) by sublingual route
16187836|NCT01488175|Procedure|tourniquet|a tourniquet around the thigh is used during insertion of the TKA to achieve a bloodless environment
16187837|NCT01488175|Procedure|no tourniquet|a tourniquet around the thigh is not used during insertion of the TKA
16187838|NCT01488136|Drug|Diazoxide|Diazoxide 7mg/kg, given 2 hours before the start of the clamp study
16187839|NCT01488136|Drug|Placebo|Lactose Ph capsules (Placebo)
16187840|NCT01488123|Behavioral|Individualized manualized Ayurvedic intervention|The manualized intervention will begin with an initial clinic visit (approximately 90 minutes) with the Ayurvedic practitioner in which the patient's diagnosis will be determined, an overview of Ayurveda will be given, and the initial treatment will be recommended based on the Ayurvedic diagnosis. Follow-up visits will range between 30 and 60 minutes in duration. The treatment modalities employed in the study will include nutrition, lifestyle, yoga, and marma (a treatment similar to acupressure).
16187841|NCT01488110|Device|In-house prototype invented by Jan-Erik Juto|30 minutes treatment with an active nasal probe.
16187842|NCT01488110|Device|In-house prototype invented by Jan-Erik Juto|30 minutes treatment with an inactive nasal probe.
16187843|NCT01488097|Drug|sebelipase alfa|Sebelipase alfa is a recombinant human lysosomal acid lipase.
16187844|NCT01488084|Procedure|Coronary Artery Bypass Graft Surgery|Comparison of two techniques of saphenous vein graft harvesting for coronary artery bypass graft surgery
16187845|NCT01488084|Procedure|Conventional open SVG harvesting|SVG harvested using conventional open technique and manually distended with crystalloid solution
16187846|NCT01488071|Drug|Vortioxetine (Lu AA21004)|encapsulated tablets, daily, orally
16187847|NCT01488071|Drug|Agomelatine|encapsulated tablets, daily, orally
16187848|NCT01488058|Other|OxIGen + iCBT|OxIGen is an Internet-based intervention taking place over 1 week followed by iCBT, an Internet-based treatment for depression taking place over 10 weeks.
16187849|NCT01488058|Other|Waitlist Control|Waitlist will receive iCBT at week 11
16187850|NCT01488045|Drug|Fentanyl|Fentanyl will be administered IV according to standard procedure for colonoscopy. Initial dose will consist of no more than 50µg of Fentanyl. Patient response will be monitored for 30-60 seconds of observation before deciding to administer more Fentanyl in no more than 50µg increments. increments.
16187851|NCT01488045|Drug|Propofol|Propofol will be administered IV according to standard procedure for colonoscopy. The initial bolus of propofol will be up to 60 mg IV. Patient response will be monitored for 30-60 seconds of observation before deciding to administer more sedation in 10-20 mg boluses.
16187852|NCT01488045|Drug|Midazolam|Midazolam will be administered IV according to standard procedure for colonoscopy. Initial dose will consist of no more than 2 mg of Midazolam. Patient response will be monitored for 30-60 seconds of observation before deciding to administer more Midazolam in no more than 2 mg increments.
16187853|NCT01488019|Drug|Perforomist-Placebo|Placebo vehicle, 2mL, twice daily for 52 weeks
16187854|NCT01488019|Drug|Perforomist, nebulization, COPD|Perforomist, 20 mcg/2 mL, twice daily for 52 weeks
16187855|NCT01488006|Device|Bigliani/Flatow Shoulder System|Primary Total Shoulder Arthroplasty with the Bigliani/Flatow prosthesis
16188029|NCT01486550|Drug|Voluven (Hydroxyethyl starch 130/0,4)|7,5 ml/kg in the first hour and then 5 ml/kg minimum
16187856|NCT01487993|Drug|Metformin|Oral administration, 500 mg daily at week 1. Every week metformin dosage increases with 500 mg, to a maximum dose of 1000 mg bid. This maximum dose will be administered till the end of the study.
16187857|NCT01487993|Behavioral|Lifestyle intervention|Lifestyle intervention: 18 months physical therapy and dietary advice
16187858|NCT01487980|Procedure|Cord clamping|Early vs Delayed
16187859|NCT01487967|Other|Preference and Goal Instrument|Families in the intervention arm will receive culturally appropriate educational material, complete the Preference and Goal Instrument at the study start, use the results to inform decision making about ADHD treatment, have their preferences/goals tracked in the electronic health record, and have their progress toward their goals assessed at 3 months and 6 months (approximately).
16187860|NCT01487954|Dietary Supplement|alkaline water|Patients drink 8 ounces of alkaline water within 30 minutes immediately prior to and after undergoing radiation therapy.
16187861|NCT01487954|Dietary Supplement|distilled water|Patients also drink 8 ounces of distilled water within 30 minutes immediately prior to and after undergoing radiation therapy.
16187862|NCT01487954|Radiation|external beam radiation therapy (EBRT)|Patients undergo external beam radiation therapy QD, 5 days a week for 6 weeks.
16187863|NCT01487928|Dietary Supplement|Human Milk Cream|If the caloric level of human milk (mother's own or donor) falls below 20 kcal/oz, then an appropriate amount of human milk cream will be added to the milk to bring the content as close as possible to 20 kcal/oz. For example, if the human milk is 19 kcal/oz, 2 mL of human milk cream will be added to 100mL of human milk.
16187864|NCT01487915|Drug|GCb|Gemcitabine 1000 mg/㎡ D1, D8 plus Carboplatin AUC=4.5 D1 every 3 weeks
16187865|NCT01487915|Drug|GemOx|Gemcitabine 1000 mg/㎡ D1 plus Oxaliplatin 100 mg/㎡ D1 every 2 weeks
16187866|NCT01487902|Drug|ADT|Luprolide 11.25 mg long-acting depo (Lucrin Depot PDS inj®) every 12 weeks SC wit Docetaxel-prednisolone (TAX327 regimen)
16187867|NCT01487902|Drug|No ADT|Docetaxel-prednisolone (TAX327 regimen) alone
16187868|NCT01487889|Other|Fatty acid composition of complementary food|Groups receive commercial vegetable-potato-meat-meals as part of complementary food which differs in the fatty acid composition
16187869|NCT01487876|Biological|HBV DNA vaccine|HBV DNA vaccine means that each volunteer received 4 injections of 4 mg DNA vaccine scheduled by a prime and 3 boosts at intervals of 4, 8, 12 weeks.
16187870|NCT01487876|Other|Placebo|Placebo means the arm in which each volunteer received 4 injections of 4 mg placebo scheduled by a prime and 3 boosts at intervals of 4, 8, 12 weeks.
16187871|NCT01487863|Biological|sipuleucel-T|Sipuleucel-T is an autologous cell product consisting of antigen presenting cells (APCs) loaded with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
16187872|NCT01487863|Drug|abiraterone acetate|Abiraterone acetate (1000 mg po QD) was administered in combination with prednisone (5 mg po BID) for a total of 26 weeks.
16187873|NCT01487850|Biological|blood sample|blood sample in each musician to search for specific antibodies against molds isolated from instruments
16187874|NCT01487837|Drug|Human fibrinogen concentrate|Administration of human fibrinogen concentrate (30 mg / kg bw) over 15 min Repetition if hourly intraoperative ROTEM measurements revealed hypofibrinogenemia according to treatment group definition
16187875|NCT01487811|Drug|biphasic insulin aspart 30|Single dose administrated subcutaneously (s.c., under the skin)
16187876|NCT01487798|Drug|biphasic human insulin 30|Administrated s.c. (subcutaneously, under the skin) for 16 weeks in treatment period 1 followed by 16 weeks in treatment period 2
16187877|NCT01487798|Drug|biphasic insulin aspart 30|Administrated s.c. (subcutaneously, under the skin) for 16 weeks in treatment period 1 followed by 16 weeks in treatment period 2
16187878|NCT01487785|Drug|LDE225+gemcitabine|Patients will receive increasing doses of LDE225 (from 400 mg), depending on the cohort they are assigned to, orally once daily and standard doses of gemcitabine (1000 mg/m2) on days 1, 8 and 15 of every 28-day cycle. Patients will receive the study treatment until they progressed, experience unacceptable toxicity, withdraw from the study, or the investigator decides it is in their best interest to discontinue the study treatment.
16187879|NCT01487759|Dietary Supplement|Oligofructose enriched inulin|
16187880|NCT01487759|Dietary Supplement|Maltodextrin|
16187881|NCT01487733|Genetic|gene expression analysis|
16187882|NCT01487733|Genetic|in situ hybridization|
16187883|NCT01487733|Other|immunohistochemistry staining method|
16187884|NCT01487733|Other|laboratory biomarker analysis|
16187885|NCT01487720|Drug|GEMOX|Gemcitabine 1000 mg/m2 IV on day 1 every 2 weeks (fixed-dose rate 10 mg/m2/min) Oxaliplatin 100 mg/m2 IV on day 1 every 2 weeks Prednisolone 5 mg twice a day orally daily
16187886|NCT01487707|Behavioral|Voluntary Health Worker (VHW) Program|Voluntary Health Workers will conduct door-to-door campaigns on maternal and child health, and will visit pregnant women regularly to to educate and to encourage use of antenatal care and facility-based deliveries.
16187887|NCT01487707|Behavioral|Safe Birth Kit|A safe birth kit, containing sterile materials to diminish infection risk will be given to pregnant women.
16187888|NCT01487707|Behavioral|Community Folk Media Campaigns|Community-wide media activities, including dramas, intended to address community norms regarding maternal and child health.
16187889|NCT01487694|Drug|cimicifuga racemosa|Cimicifuga racemosa (black cohosh) rhizome and root extract 40 mg once daily for 12 weeks (equivalent to triterpene glycosides 12.3 mg)
16187890|NCT01487694|Drug|placebo|matching placebo without active ingredient 1 tab daily for 12 weeks
16187891|NCT01487668|Behavioral|Life Goals Collaborative Care|LGCC consists of 1) 10 self-management sessions that cover personal goal-setting and mental health symptom management reinforced through healthy lifestyles; 2) medical care management that includes identification of patient medical risk factors, monitoring of patient symptoms and medical needs via a registry over time; and 3) support for provider guidelines and community linkages.
16187892|NCT01487642|Device|Standard 15-minute telephone counselling|Subjects in arm 1 will benefit from a standard 15-minute telephone counselling session with a professional adviser which resembles a normal call to the national Quit-line. The telephone counselling will be reactive, thus the smoker initiates the call to a designated number to receive advice and information based on the needs and wishes of this particular smoker. Participants can receive self-help materials and information on other smoking cessation services if they wish.
16187893|NCT01487642|Device|Proactive telephone counselling|subjects in arm 2 will benefit from of five 15-minute calls from a professional adviser. Similar to the standard reactive telephone counselling, the proactive counselling will be a personal discussion and advice based on the needs and wishes of the particular participant. Together, the participant and adviser will determine a cessation date and schedule one call 3-7 days before the cessation date, one call immediately after the cessation date and three additional calls on days 3, 10 and 24, respectively, post-cessation.
16187894|NCT01487642|Device|Interactive web-based smoking cessation programme|Subjects in arm 3 will benefit from a tailored and interactive web-based smoking cessation programme. Besides interactive and personalised information generated on the webpage, the participant will receive by e-mail and SMS tailored feedback messages based on the particular profile of the participant on particular dates as well as topics during the cessation period depending on how well the cessation is proceeding.
16187895|NCT01487642|Device|Self-help material|Participants receives self-help materials and on request information on other smoking cessation services if they wish.
16187896|NCT01487629|Drug|Bevacizumab|Bevacizumab, 1.5 mg, intravitreal, throughout the study
16187897|NCT01487629|Drug|Ranibizumab|Ranibizumab, 0.5 mg, intravitreal, throughout the study
16187898|NCT01487590|Other|Acupuncture moxibustion|Six interventions with acupuncture moxibustion, stimulating point BL67, during 20 minutes each, 48 hours apart.
16187899|NCT01487590|Other|Placebo|Six interventions with placebo (inactivated laser), stimulating point BL67, during 20 minutes each, 48 hours apart
16187900|NCT01487577|Drug|Mycophenolate mofetil|Based on individual pharmacokinetics data, mycophenolate mofetil will be administered by continuous infusion to target a desired AUC exposure
16187901|NCT01487564|Drug|Hydromorphone 16 mg|type= exact number, unit= mg, number= 16, format= tablet, route= oral use. One tablet of hydromorphone 16 mg.
16187902|NCT01487551|Drug|paquinimod|Hard gelatine capsules 3.0 mg/day for 8 weeks
16187903|NCT01487538|Behavioral|Videos|Provide information on physical activity, diet, calorie tracking to support weight maintenance in rural women.
16187904|NCT01487538|Behavioral|Action Plans|Online action plans will be used by subjects to set and evaluate physical activity goals
16187905|NCT01487538|Behavioral|Discussion Boards|forum to exchange information and experiences
16187906|NCT01487538|Behavioral|Health behavior tracking|online tracking of weight for both intervention and standard advice group. In addition, the intervention group will also track their calories in and out and their pedometer steps
16187907|NCT01487525|Device|Double leg press with partial blood flow restriction|double isotonic and isokinetic leg press extension with application of partial blood flow restriction to the upper leg
16187908|NCT01487525|Other|Double leg press without partial blood flow restriction|double isotonic and isokinetic leg press extension without application of partial blood flow restriction to the upper leg
16187909|NCT01487512|Drug|Treatment A: Hydromorphone 8 mg|type= exact number, unit= mg, number= 8, form= tablet, route= oral use. One tablet of Hydromorphone 8 mg in each of 4 treatment sequences.
16187910|NCT01487512|Drug|Treatment B: Hydromorphone 16 mg|type= exact number, unit= mg, number= 16, form= tablet, route= oral use. One tablet of Hydromorphone 16 mg in each of 4 treatment sequences.
16187911|NCT01487512|Drug|Treatment C: Hydromorphone 32 mg|type= exact number, unit= mg, number= 32, form= tablet, route= oral use. One tablet of Hydromorphone 32 mg in each of 4 treatment sequences.
16187912|NCT01487512|Drug|Treatment D: Hydromorphone 64 mg|type= exact number, unit= mg, number= 64, form= tablet, route= oral use. One tablet of Hydromorphone 64 mg in each of 4 treatment sequences.
16187913|NCT01487499|Drug|Cisplatin|40 mg in 40 mL of normal saline for each of 4 bronchoscopies
16187914|NCT01487486|Drug|IVF Antagonist Protocol|"Ovulation Induction: Achieved with recombinant FSH (Follistim®) with or without HMG (Menopur®) at total doses of 75-450 IU/day subcutaneous (SC) for 9-14 days.
~Ovulation Suppression: GnRH Antagonist (Ganirelix® - 250microgram 0.5ml) will be initiated following ovulation induction when lead follicle >14mm diameter on ultrasound and continued through the day of hCG (Novirel® or Ovidrel ®) injection
~hCG Injection: Once patient has met criteria for oocyte retrieval, she will inject either Novarel® (5,000-10,000 units Intramuscular) or Ovidrel® (250microgram - 500microgram SC) 35 hours prior to oocyte retrieval."
16187915|NCT01487473|Behavioral|Mindfulness-Based Stress Reduction|An 8-week structured group program that was developed to improve psychological and physical symptoms associated with pain. It incorporates a variety of mindfulness meditation exercises including mindful yoga, sitting meditation, and body scan to facilitate attention, acceptance, and awareness of one's experiences.
16187916|NCT01487460|Drug|TAP311|
16187917|NCT01487447|Other|Customized sound|treatment with customized sound therapy
16187918|NCT01487447|Other|Regular Masker|treatment with white noise
16187919|NCT01487434|Behavioral|Check & Connect|Structured mentoring and case management
16187920|NCT01487421|Drug|insulin aspart|Subjects were observed over a time period of 12 weeks after initiation of a supplementary insulin therapy regimen (SIT) with insulin aspart at mealtimes. Administrated subcutaneously (s.c., under the skin)
16187921|NCT01487421|Drug|insulin detemir|Insulin detemir were added to insulin aspart in the evening or at bedtime, if needed. Administrated subcutaneously (s.c., under the skin)
16187922|NCT01487408|Drug|insulin aspart|Adminstered subcutaneously (s.c., under the skin). Prescribed by physician as a results of normal clinical practice
16187923|NCT01487395|Drug|Donepezil .|Donepezil will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days.
16187924|NCT01487395|Drug|Placebo|the placebo will be administered OS as of 5 mg- Orally Disintegrating Tablets one per day in the morning over 15 days.
16187925|NCT01487382|Drug|insulin aspart|Injected subcutaneously (s.c., under the skin). Prescribed by physician as a result of normal clinical practice
16187926|NCT01487369|Drug|insulin aspart|Injected subcutaneously (s.c., under the skin). Prescribed by physician as a result of normal clinical practice.
16187927|NCT01487356|Other|No intervention|Colonoscopies were conducted as per the endoscopist's usual practice. No change in protocol was expected.
16187964|NCT01487031|Other|Music Therapy|Patients randomized to receive music therapy will receive 2 sessions of live music therapy, at least 48 hours apart, from a Music Therapist-Board Certified (MT-BC, certified through the Certification Board for Music Therapists) in their room
16187928|NCT01487343|Behavioral|questionnaire and interview|Interviews will be conducted with the first 10 participants who agree to be interviewed (or until data saturation is reached). Self-report questionnaires assessing adherence, beliefs about medications, side effect experience, self-efficacy, and satisfaction with patient education; the qualitative portion is an interview guided by two open-ended questions. Data will be collected approximately 2 weeks - 6 months (2 - 24 weeks) after being prescribed capecitabine.
16187929|NCT01487330|Device|Transcatheter Aortic Valve Implantation (TAVI)|Placement of the SJM TAVI aortic valve with a transfemoral delivery system.
16187930|NCT01487317|Drug|Rivastigmine transdermal patch|One transdermal patch of Rivastigmine (equivalent to 4.6 mg/24h per os) per day from randomization to day 14 before day 14: end od treatment, if DRS R-98 severity < 10 during 2 consecutive days At day 14, if DRS R-98 severity ≥ 10: one transdermal patch of Rivastigmine 9.5 mg/24h per day from day 14 to day 30 if DRS R-98 severity < 10, the active treatment will be stopped
16187931|NCT01487317|Drug|placebo patch|One transdermal patch of placebo per day from randomization to day 14 Before day 14: end of treatment if DRS R-98 severity < 10 during 2 consecutive days, At day 14 if DRS R-98 severity ≥ 10: One transdermal patch of placebo per day from day 14 to day 30 if DRS R-98 severity < 10, the placebo treatment will be stopped
16187932|NCT01487304|Drug|Marketed low dose hormone replacement therapy|A low dose of marketed HRT products prescribed at the discretion of the treating physician
16187933|NCT01487278|Drug|misprostol|600 mcg misoprostol oral
16187934|NCT01487278|Device|UnijectTM|10 IU oxytocin delivered intramuscularly with UnijectTM
16187935|NCT01487265|Drug|BKM120 and Erlotinib|BKM120 and Erlotinib will be given once daily. Erlotinib 100 mg PO will be administered. During Cycle 1-Week 1 all patients will receive 80 mg PO daily BKM120. After the first week of Cycle 1, the dose of BKM120 will escalate to 100 mg PO daily and treatment will continue as long as there are no unexpected or prohibitive toxicities, or disease progression.
16187936|NCT01487252|Behavioral|At home saliva sampling|Saliva samples taken every half an hour in evening before bedtime.
16187937|NCT01487239|Drug|[14C]-GDC-0980|100 uCi of [14C]-GDC-0980 in total dose of 10 mg GDC-0980
16187938|NCT01487226|Drug|paclitaxel|Paclitaxel 175 mg/m2 over 3 hr Repeat every 3 weeks * 6 cycles
16187939|NCT01487226|Drug|Cisplatin 50mg/m2|"Cisplatin 50mg/m2
~Repeat every 3 weeks * 6 cycles"
16187940|NCT01487213|Other|Home self assessment of complete medical abortion|Self assessment of complete abortion using a home semiquantitative U-hCG test. Follow-up out patient review two-three weeks later by qualified practitioner to evaluate success of procedure using the clinic's standard routine. The patient charts will be reviewed after three months in order to control for possible extra visits related to abortion-related complications.
16187941|NCT01487200|Drug|FX006 10 mg|single 3 mL IA injection
16187942|NCT01487200|Drug|FX006 40 mg|single 3 mL IA injection
16187943|NCT01487200|Drug|FX006 60 mg|single 3 mL IA injection
16187944|NCT01487200|Drug|TCA IR 40|single 1 mL IA injection
16187945|NCT01487187|Procedure|Milking the umbilical cord at birth|Infants in the cord-milked group will be placed at or below the level of the placenta, and about 20 cm of the umbilical cord (or the length of cord that is accessible if less than 20 cm) will be vigorously milked towards the umbilicus three times before clamping the cord
16187946|NCT01487187|Procedure|immediate umbilical cord clamping|immediate cord clamping without milking as per standard practice
16187947|NCT01487174|Drug|KD019|KD019 will be administered orally once daily at a dose of 300 mg. One dose reduction to 200 mg will be permitted.
16187948|NCT01487174|Drug|Erlotinib|Erlotinib will be administered orally once daily at a dose of 150 mg. One dose reduction to 100 mg daily will be permitted.
16187949|NCT01487161|Drug|FX006|Single 3 mL intra-articular injection
16187950|NCT01487161|Drug|TCA IR|Single 1 mL intra-articular injection
16187951|NCT01487135|Drug|EVP-6124|A single oral low dose of EVP-6124 in cranberry juice (180 mL) administered on Day 1 and a high dose of EVP-6124 in cranberry juice (180 mL) administered on Day 2.
16187952|NCT01487135|Drug|Placebo|Cranberry juice only (180 mL) administered orally on both Day 1 and Day 2.
16187953|NCT01487135|Drug|Moxifloxacin|A moxifloxacin 400 mg tablet administered orally on Day 1
16187954|NCT01487122|Radiation|Continuous microwave|Continuous microwave through a great circular electrode, 15 cm from the neck, 20 minutes, 80 watts, 15 sessions in 3 weeks
16187955|NCT01487122|Radiation|Pulsed microwaves|Pulsed microwaves through a great circular electrode, 15 cm away from the neck, 20 minutes, 80 watts, 15 sessions in 3 weeks
16187956|NCT01487122|Procedure|Sham microwaves|Unplugged microwave generator, great circular electrode, 15 cm away from the neck, 20 minutes, 15 sessions in 3 weeks
16187957|NCT01487109|Drug|CTP-499|600 mg tablet twice daily
16187958|NCT01487109|Drug|Placebo|Matching placebo tablet
16187959|NCT01487096|Drug|Teriflunomide|"film-coated tablet
~oral administration"
16187960|NCT01487096|Drug|Placebo (placebo for teriflunomide)|"film-coated tablet
~oral administration"
16187961|NCT01487083|Drug|Pomaglumetad methionil|Administered orally
16187962|NCT01487070|Drug|Macugen (Pegaptanib Sodium)|"Pegaptanib sodium drug substance is a pegylated (40 kDa branched PEG molecule consisting of two 20 kDa PEG arms) anti-VEGF aptamer. It is formulated in phosphate buffered saline at pH 6-7. Sodium hydroxide or hydrochloric acid may be added for pH adjustment.
~Pegaptanib sodium is formulated at 0.3mg/90µl and presented in a USP Type I glass barrel syringe sealed with a bromobutyl rubber stopper. A 30-guage needle is fixed to the end of the syringe after removal of the rubber stopper. The syringe comes in a sealed foil pouch, and the 30-gauge needle is added to the sterile injection field separately. The drug product is preservative-free and intended for single use by intravitreous injection only."
16187963|NCT01487044|Drug|Macugen (Pegaptanib Sodium)|"Pegaptanib sodium drug substance is a pegylated (40 kDa branched PEG molecule consisting of two 20 kDa PEG arms) anti-VEGF aptamer. It is formulated in phosphate buffered saline at pH 6-7. Sodium hydroxide or hydrochloric acid may be added for pH adjustment.
~Pegaptanib sodium is formulated at 0.3mg/90µl and presented in USP Type I glass barrel syringes sealed with a bromobutyl rubber plunger stopper. The syringe has a needle attachment at allows for a 30-guage need to be fixed to the syringe prior to injection. The stoppered syringe is packaged in a foil pouch. The drug product is preservative-free and intended for single use by intravitreous injection only."
16188027|NCT01486563|Drug|Voluven (Hydroxyethyl starch 130/0,4)|7,5 ml/kg in the first hour and then 5 ml/kg
16187965|NCT01487031|Other|No music therapy|Those patients randomized to standard therapy (no music therapy) are allowed to listen to music; however they will not receive interactive music therapy from a certified therapist.
16187966|NCT01487018|Procedure|Navigation Surgery|To evaluate the feasibility and accuracy of a new method for planning and realizing zygomatic osteotomies in cases of established post-traumatic deformities using computer assisted navigation.
16187967|NCT01487018|Procedure|Traditional Surgery|To compare with the experamental group.
16187968|NCT01486992|Drug|mFOLFIRI+Nimotuzumab|irinotecan 180mg/m2，iv ，d1，LV 200 mg/m2 ，2h，d1，5-FU 400 mg/m2， iv，d1 5-FU 2400mg/m2，CIV，46h，q2w Nimotuzumab 200mg，iv，qw
16187969|NCT01486979|Drug|estradiol, 10 mcg|One vaginal tablet once daily in the morning during the first two weeks of treatment followed by one vaginal tablet twice weekly in the morning for 10 weeks
16187970|NCT01486979|Drug|estradiol, 25 mcg|One vaginal tablet once daily in the morning during the first two weeks of treatment followed by one vaginal tablet twice weekly in the morning for 10 weeks
16187971|NCT01486966|Drug|insulin detemir|Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) once daily using NovoPen®4
16187972|NCT01486966|Drug|insulin aspart|Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) three times a day before a meal using NovoPen®4
16187973|NCT01486966|Drug|insulin NPH|Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) once daily using NovoPen®4
16187974|NCT01486966|Drug|human soluble insulin|Dose individually adjusted. Administered subcutaneously/s.c. (under the skin) three times a day before a meal using NovoPen®4
16187975|NCT01486966|Drug|metformin|For subjects previously treated with metformin, the dosage and frequency will be kept unchanged
16187976|NCT01486953|Drug|Desflurane|Using random numbers, patients were divided into two groups to receive either sevoflurane or desflurane. After induction of anesthesia and intubation, the patient's lungs were ventilated in constant-flow VCV mode by an anesthetic Ventilator (Datex-Ohmeda, GE healthcare, Finland). Ventilator settings were tidal volume 10 ml/kg, inspiratory:expiratory (I:E) ratio 1:1.5, inspired oxygen concentration (FiO2) 0.5 with air, and 3 L/min of inspiratory fresh gas flow. End-inspiratory pause was set 20% of total breathing cycle. Positive end-expiratory pressure (PEEP) was not used. Respiratory rate was adjusted to maintain an end-tidal CO2 pressure of 33-35 mmHg. Patients received desflurane 6-7% for maintenance of anesthesia.
16187977|NCT01486953|Drug|Sevoflurane|Using random numbers, patients were divided into two groups to receive either sevoflurane or desflurane. After induction of anesthesia and intubation, the patient's lungs were ventilated in constant-flow VCV mode by an anesthetic Ventilator (Datex-Ohmeda, GE healthcare, Finland). Ventilator settings were tidal volume 10 ml/kg, inspiratory:expiratory (I:E) ratio 1:1.5, inspired oxygen concentration (FiO2) 0.5 with air, and 3 L/min of inspiratory fresh gas flow. End-inspiratory pause was set 20% of total breathing cycle. Positive end-expiratory pressure (PEEP) was not used. Respiratory rate was adjusted to maintain an end-tidal CO2 pressure of 33-35 mmHg. Patients received sevoflurane 2-2.5% for maintenance of anesthesia.
16187978|NCT01486940|Drug|insulin detemir|Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily
16187979|NCT01486940|Drug|insulin aspart|Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals
16187980|NCT01486940|Drug|insulin NPH|Individually adjusted dose administered subcutaneously (s.c., under the skin) twice daily
16187981|NCT01486940|Drug|human soluble insulin|Individually adjusted dose administered subcutaneously (s.c., under the skin) prior to meals
16187982|NCT01486927|Biological|rVIII-SingleChain|In Part 1 of the study, subjects received a single intravenous infusion of 50 IU/kg recombinant, single-chain coagulation factor VIII (rVIII-SingleChain) preceded by a 4-day washout period. In Parts 2 and 3 of the study, subjects received repeat injections of rVIII-SingleChain either as an on-demand or prophylaxis regimen at a dose and frequency determined by their study doctor. Subjects participating in the Part 3 PK analyses received a single infusion of 50 IU/kg rVIII-SingleChain and a repeat dose of the same strength of rVIII-SingleChain after 3 to 6 months. Subjects from Parts 2 and 3 participating in the surgical substudy received an individualized dose regimen of rVIII-SingleChain, based on the type of surgery and the clinical status of the subject.
16187983|NCT01486927|Biological|Octocog alfa|In Part 1 of the study, subjects received a single intravenous infusion of 50 IU/kg of octocog alfa preceded by a 4-day washout period. Octocog alfa is the international nonproprietary name (INN) for recombinant human coagulation factor VIII.
16187984|NCT01486914|Drug|insulin aspart|Single dose of each formulation administrated subcutaneously (s.c., under the skin) at two separate dosing visits
16187985|NCT01486901|Drug|isophane human insulin|Single dose of each formulation, administered subcutaneously (s.c., under the skin) on two separate dosing visits
16187986|NCT01486888|Drug|biphasic human insulin 30|Single dose of each formulation, administered subcutaneously (s.c., under the skin) on two separate dosing visits
16187987|NCT01486875|Drug|biphasic insulin aspart 30|Dose individually adjusted, and administered subcutaneously (under the skin) once or twice daily
16187988|NCT01486862|Drug|biphasic insulin aspart 30|Dose individually adjusted. Administered once daily for 16 weeks. If HbA1c after 16 weeks of treatment is above 7.0%, insulin is administered twice daily for additional 16 weeks.
16187989|NCT01486849|Drug|CK-2017357|Total daily oral dose of 250 mg (125 mg BID) of CK-2017357 for 7 days followed by total daily oral dose of 375 mg (125 mg AM and 250 mg PM) for 7 days followed by total daily oral dose of 500 mg (250 mg BID) of CK-2017357 for 7 days
16187990|NCT01486849|Drug|Placebo|Matching placebo tablets BID for 21 days
16187991|NCT01486849|Drug|Riluzole 50 MG|
16187992|NCT01486823|Drug|MLDL1278A|Single intravenous dose of 360 mg MLDL1278A followed by a single subcutaneous dose of 360 mg MLDL1278A.
16187993|NCT01486823|Drug|MLDL1278A|Single subcutaneous dose of 360 mg MLDL1278A.
16187994|NCT01486810|Drug|Lisdexamfetamine|Patients will be titrated to the tolerated dose over a two week period, with a maximum of 140mg daily, and then maintained on the highest tolerated dose for four weeks
16187995|NCT01486810|Behavioral|medication management|All participants will receive medication management counseling and individual therapy using a structured compliance enhancement manual designed for pharmacotherapy trials in subjects with substance use disorders.
16188028|NCT01486563|Drug|Sodium Chloride 9 mg/ml|7,5 ml/kg in the first hour and then 5 ml/kg
16192771|NCT01451203|Drug|methotrexate (MTX)|oral
16187996|NCT01486797|Drug|NOX-A12|"Pilot Group (NOX-A12 single agent, and combined with BR):
~3 cohorts of 3 patients will receive treatment with NOX-A12 alone at a single dose of 1, 2 or 4 mg/kg i.v. 2 weeks before the combination treatment of NOX-A12 and BR begins.The combination of NOX-A12 and BR will follow a dose titration design beginning at 1 mg/kg NOX-A12 (cycle 1), proceeding to dose levels of 2 mg/kg (cycle 2) and 4 mg/kg (cycle 3) NOX-A12 in combination with BR. This is followed by consolidation in cycles 4-6 when NOX-A12 will be kept at the highest individually titrated dose.
~Expansion Group (NOX-A12 in combination with BR):
~Expansion patients will not receive single agent NOX-A12, but will receive combination treatment as for the pilot group."
16187997|NCT01486784|Drug|Birinapant|IV formulation to be given weekly 3 weeks out of 4 week cycle or 4 weeks our of a 4 week cycle as a 30 minute infusion
16187998|NCT01486771|Drug|Macugen ® (pegaptanib sodium)|"Patients assigned to either IV Mac Q6Arm will receive a total of 3 intravitreal pegaptanib sodium injections administered at 6-week intervals beginning on Day 0 and ending at Week 12. The group will then receive an intravitreal injection every 12 weeks.
~Patients assigned to IV Mac Q6Arm will receive a total of 3 intravitreal pegaptanib sodium injections administered at 6-week intervals beginning on Day 0 and ending at Week 12. After the third injection subjects in this group will receive Selective Laser Photocoagulation at Week 18.
~Patients assigned to Panretinal Photocoagulation will act as the control group. Subjects in this group will receive standard Panretinal Photocoagulation using a modified ETDRS protocol.
~All intravitreal study injections will consist of 0.3 milligrams (mg) of pegaptanib sodium delivered by intravitreal injection."
16187999|NCT01486758|Drug|Azithromycin|Oral azithromycin 10 mg/kg once daily for 7 days followed by 5mg/kg once daily for additional 7 days.
16188000|NCT01486758|Drug|Placebo|
16188001|NCT01486732|Biological|Umbilical Cord Blood Infusion|The subjects will be undertaken allogeneic umbilical cord blood infusion intravenously or intraarterially under non-myeloablative immunosuppression.
16188002|NCT01486732|Other|Active Rehabilitation|All subjects should participate in active rehabilitation. They will receive two physical and occupational therapy sessions per day. Post discharge, each participant continued to receive rehabilitation therapy at least 3 days per week for additional 2.5 months.
16188003|NCT01486732|Other|Placebo Umbilical Cord Blood|Placebo Umbilical Cord Blood that resembles cord blood in appearance was designed : 1.5 to 3 ml of the subject's own blood was collected and mixed with 15 to 20 ml of albumin
16188004|NCT01486719|Procedure|Sensate Dorsal Digital Island Flap|This article reports repair of the finger pulp defect using the dorsal digital island flap. Both dorsal branches of the proper digital nerves (PDNs) were used for maximal sensory restoration.
16188005|NCT01486706|Drug|Gabapentin|100mg/capsule initially one capsule once a day then titrate according to the symptoms of the patient upto maximum dose of 1500mg/day
16188006|NCT01486706|Drug|Solifenacin Succinate|5mg/tablet initially 1 tablet once a day then titrate up to maximum dose of 10mg/tab
16188007|NCT01486706|Drug|Placebo drugs|will titrate medications similar to the active drug group
16188008|NCT01486680|Procedure|Laparoscopic Silastic Ring Roux-en-Y Gastric Bypass|An isolated lesser curve-based gastric pouch will be created, with an antecolic antegastric Roux limb fashioned measuring 100 cm in length. The biliopancreatic limb will measure 50cm for all patients. A 6.5cm silastic ring will be placed above the gastrojejunostomy to prevent long term stomal dilatation.
16188009|NCT01486680|Procedure|Laparoscopic Sleeve gastrectomy|Resection of the greater curvature of the stomach from the distal antrum (2cm proximal to pylorus) to the angle of His, using a laparoscopic stapling device over a 36Fr bougie, will be performed to create a lesser curve gastric sleeve
16188010|NCT01486667|Drug|levothyroxine|Eligible patients will be randomized and be given 25 mcg of levothyroxine or identical placebo tablet at the beginning of the enrollment. The dosage of levothyroxine will subsequently be individualized for each patients according to Serum levels of TSH and FT4 which will be checked initially and then every 6 weeks until the end of the study. The investigators will attempt to maintain TSH levels between (0.25-2.5) mU/l which is the lower half of normal range by adding or reducing the dose of levothyroxine. Advice given to patient regarding whether to increase or decrease the dose of medications will be based on patient TSH level according to study protocol.
16188011|NCT01486667|Drug|sugar pill|Eligible patients will be randomized and be given 25 mcg of levothyroxine or identical placebo tablet at the beginning of the enrollment. The dosage of drug will subsequently be individualized for each patients according to Serum levels of TSH and FT4 which will be checked initially and then every 6 weeks until the end of the study. The investigators will attempt to maintain TSH levels between (0.25-2.5) mU/l which is the lower half of normal range by adding or reducing the dose of medication. Advice given to patient regarding whether to increase or decrease the dose of medications will be based on patient TSH level according to study protocol.
16188012|NCT01486654|Device|Transcranial Direct Current Stimulation - Cathodal stimulation|Cathodal transcranial direct stimulation (tDCS) to the left hemisphere, 1.0 mA for 13 minutes, is received five days a week, for six weeks, during the initial 13 minutes of 90 minutes of speech-language treatment.
16188013|NCT01486654|Device|Transcranial Direct Current Stimulation - Anodal stimulation|Anodal transcranial direct stimulation (tDCS) to the left hemisphere, 1.0 mA for 13 minutes, is received five days a week, for six weeks, during the initial 13 minutes of 90 minutes of speech-language treatment.
16188014|NCT01486654|Device|Transcranial Direct Current Stimulation - Sham stimulation|Sham stimulation provided together with 90 minutes of speech language therapy, 5 days a week, for 6 weeks.
16188015|NCT01486641|Procedure|Anterolateral approach|Anterolateral approach acording to Gammer for hip arthroplasty.
16188016|NCT01486628|Drug|ND0612|levodopa and carbidopa solution for subcutaneous administration
16188017|NCT01486628|Drug|Placebo|Saline solution for SC continuous administration
16188018|NCT01486615|Drug|meloset (melatonin)|3 mg melatonin tablet 1-2 hour prior surgery
16188019|NCT01486615|Drug|stresnil ( melatonin and alprazolam)|3 mg melatonin and 0.5 mg alprazolam 1-2 hr before anesthesia
16188020|NCT01486615|Drug|(alprax) alprazolam|0.5 mg alprazolam
16188021|NCT01486615|Drug|placebo|similar looking placebo tablet
16188022|NCT01486602|Drug|carboplatin|IV
16188023|NCT01486602|Drug|paclitaxel|IV
16188024|NCT01486602|Radiation|radiation therapy|Defined per the protocol
16188025|NCT01486576|Drug|Voluven (Hydroxyethyl starch 130/0,4)|7,5 ml/kg in the first hour and then 5 ml/kg
16188026|NCT01486576|Drug|Sodium Chloride 9 mg/ml|7,5 ml/kg in the first hour and then 5 ml/kg
16188031|NCT01486511|Procedure|Liver resection|Hepatectomy including both minor and major.
16188032|NCT01486511|Radiation|Computed Tomography|Computed Tomography +/- pulmonary angiography
16188033|NCT01486485|Drug|heparinized saline priming group|
16188034|NCT01486485|Drug|nafamostat infusion after heparinized saline priming|
16188035|NCT01486472|Drug|S-1|Adjuvant S-1 chemotherapy will be performed to GC patients receiving curative D2 gastric surgery
16188036|NCT01486459|Drug|Lithium|250 mg daily for 6 weeks, increased 250 - 500 mg depending on plasma levels.
16188037|NCT01486446|Drug|XPF-002|XEN402 8% w/w ointment for topical application, applied to the skin twice daily for 14 or 21 days
16188038|NCT01486446|Drug|Placebo|XEN402 0% w/w ointment for topical application. Identical content and appearance to the XPF-002 ointment but without the active medicine. Applied to the skin twice daily for 14 or 21 days.
16188039|NCT01486433|Drug|Simvastatin|40 mg (1 tablet) simvastatin once a day
16188040|NCT01486433|Drug|acetylsalicylic acid (ASA)|81 mg aspirin (1 tablet), once a day, co-administered with simvastatin
16188041|NCT01486433|Drug|omefas|4 g (4 capsules) Epanova once a day, co-administered with simvastatin and aspirin
16188042|NCT01486420|Procedure|Corticosteroid injections|Corticosteroid injections in and around A1-pulley.
16188043|NCT01486420|Procedure|Open surgery|Open A1-pulley release
16188044|NCT01486394|Other|Focused Sonography of the heart, lungs and deep veins|The patient is randomised to either a control group where usual treatment and diagnostic work-up is performed or to an intervention group where usual treatment and diagnostic workup are supplemented by a sonographic examination of the heart, lungs and deep veins are performed within one hour after the primary evaluation. The primary evaluation is defined as the first evaluation of the patient by a physician in the Acute Medical Admission Department.
16188045|NCT01486381|Drug|biphasic insulin aspart 30|Administered subcutaneously (s.c., under the skin)
16188046|NCT01486368|Drug|PF-03446962|PF-03446962 will be administered by IV infusion every 2 weeks (q2w). A cycle will be 2 weeks in duration and include one administration of PF-03446962.
16188047|NCT01486355|Biological|Measles vaccine|Edmonston-Zagreb measles vaccine
16188048|NCT01486342|Radiation|PET-CT scan|"PET-CT imaging with [18F]FDG will be performed within 24 hours of admission to the ICU. All patients imaged will be those remaining on mechanical ventilation at the time of PET imaging.
~A low-dose CT scan (50 effective mAs) will be obtained with placement of the participant such that the lungs are centered within the field of view. After completing the transmission scan, 10 mCi of [18F]FDG will be injected intravenously at the start of a 60-minute dynamic scan acquisition and the intravenous (IV) catheter flushed with 10 ml saline. Imaging will be obtained with the following framing schedule: 24 5-sec, 6 3-minute and 8 5-minute frames."
16188049|NCT01486329|Biological|VXM01|Live anti-angiogenic cancer vaccine drink solution, escalating dose
16188050|NCT01486329|Biological|Placebo|Drink solution
16188051|NCT01486316|Device|Reveal XT® Insertable Cardiac Monitor|If not previously implanted, a non-experimental insertable cardiac monitor will be implanted to collect information on the patients' heart condition as inputs into the heart failure risk status algorithm (during guided follow-up only, Guided arm: 6-18 months, Control arm: 12-18 months).
16188052|NCT01486316|Other|Heart Failure Risk Status Diagnostic|"The experimental IDENTIFY-HF Risk Status developed for this study will be used to change standard device data to a heart failure risk status. The risk status and standard device trend data are provided to study doctors for remote management of their patients' heart failure using study specific protocols. The risk status inputs are: night heart rate, heart rate variability, atrial fibrillation burden, ventricular rate during atrial fibrillation, patient activity.
~Based on pre-defined thresholds for each of the above inputs, as well as data trends, a heart failure score is derived. The heart failure score is then classified as: Low, Medium, High, or Very High."
16188053|NCT01486303|Procedure|Facial Cosmetic Acupuncture|Patients received five treatment sessions during 3 weeks. Facial cosmetic acupuncture was applied at muscles and acupoints on the face, head and neck
16188054|NCT01486290|Behavioral|Behavioral|the intervention included developing strategies to help patients cope with their barriers to self care. The intervention were implemented by an office based educator over a six month by phone calls. From six months to twelve months subjects did not have any contact with study staff.
16188055|NCT01486277|Drug|Quisinostat, 12 mg|Participants will receive quisinostat 12 mg capsule orally (by mouth) on Days 1, 3, and 5 of each week in a 21-day treatment cycle, until a reason for discontinuation is met (ie, disease progression, toxicity, availability of other effective medications that the participant may receive, or treating physician advice).
16188056|NCT01486264|Biological|Xeomin®|Xeomin is botulinum toxin type A produced from fermentation of Hall strain Clostridium botulinum serotype A
16188057|NCT01486251|Drug|axitinib|"Axitinib will be given BID orally. The 3 dose levels tested will be: 1st cycle: 5 mg BID; 2nd cycle: 7 mg BID; 3rd cycle: 10 mg BID.
~One cycle is defined as a 14-day period (7 days ON / 7 days OFF). Patients will receive a first cycle of single agent axitinib at the starting dose with DCE-US assessment. If no study treatment-related adverse event (AE) of grade > 1 is observed during this cycle, intrapatient dose escalation will be performed for the second cycle. The same dose escalation method wil apply between the 2d and 3d cycles."
16188058|NCT01486238|Drug|Macugen® pegaptanib sodium|"Patients assigned to either arm (IVMac q4 and IVMac q6) will receive 0.3 milligrams (mg) of pegaptanib sodium delivered by intravitreal injection administered.
~Patients assigned to IVMac q4 will receive a total of 6 intravitreal Macugen® injections administered at 4 week intervals beginning on Day 0 and ending at Week 20. Patients assigned to IVMac q6 will receive a total of 4 intravitreal Macugen® injections administered at 6 week intervals beginning on Day 0 and ending at Week 18. Each Macugen® injection will be administered as described in the package insert."
16188059|NCT01486225|Device|Innothera's brand Stockings|15 patients having used Innothera branded Stocking
16188060|NCT01486225|Other|Stockings other than Innothera's brand|15 patients having used any other brand than Innothera's brand stockings
16188061|NCT01486199|Other|Absorptive clearance scan|Subjects will inhale a nebulized mixture of the radiopharmaceuticals Indium 111-DTPA and Technetium 99m-sulfur colloid.
16188062|NCT01486186|Drug|Traditional Chinese Medicine|A herbal extract twice daily for 52 weeks for lower dosage, There are 3 Recipe for the 3 traditional Chinese syndrome, they are syndrome of lung-qi deficiency, syndrome of deficiency of pulmonosplenic qi, syndrome of insufficiency of QI of the lung and kidney.
16188063|NCT01486186|Drug|placebo chinese medicine|There are 3 placebo Recipe for the 3 traditional Chinese syndrome.
16188064|NCT01486147|Behavioral|Visual nutrient profiling tool|Shown color coded fiber and protein 2x2 plot, selected fiber and protein ratings from boxes on the plot.
16188065|NCT01486147|Behavioral|Nutrient ratings table|Showed nutrition information and had to match to fiber and protein ratings from a table.
16188066|NCT01486134|Procedure|Multipolar Radiofrequency ablation|Percutaneous multipolar radiofrequency ablation.
16188067|NCT01486121|Other|Therapy strategy|Sedation & mechanical ventilation
16188068|NCT01486108|Procedure|dorsal column stimulator|test different settings of stimulation
16188069|NCT01486095|Device|AXXESS + Biomatrix Biolimus Eluting stent|NAP
16188070|NCT01486095|Device|Culotte technique with Xience V or Xience Prime stents|NAP
16188071|NCT01486082|Other|OCA 10|A group will be treated with omeprazole (20 mg / 12 h), amoxicillin (1 g/ 12 h)and clarithromycin (500 mg/12 h) for 10 days (as following current guides) without having a previous antibiogram, and the other group will be treated after antibiotic susceptibility.
16188072|NCT01486043|Drug|Metformin|All subjects will be started on metformin 500 mg orally twice daily. The dose will be increased by 500 mg weekly as tolerated until subjects' blood glucoses are well controlled or until the patient reaches metformin 1000 mg PO BID.
16188073|NCT01486030|Diagnostic Test|Corus CAD (ASGES)|Age/Sex/Gene Expression Score - ASGES
16188074|NCT01486017|Drug|ASP015K|oral
16188075|NCT01486004|Drug|TMC435|Type = exact number, unit = mg, number = 150, form = capsule, route = oral use. Capsule is taken once daily for 10 days (Day12 till and including Day21) in 2nd OC cycle.
16188076|NCT01486004|Drug|Ovysmen|Type = exact number, unit = mg, number = 35µg/1mg, form = tablet, route = oral use. 35 µg ethinylestradiol and 1 mg norethindrone once daily for first 21 days in each OC cycle (2 OC cycles in total)
16188077|NCT01485991|Drug|TMC435|TMC435 Type=exact number, unit=mg, number=150, form=capsule, route=oral use. TVR placebo Form=tablet, route=oral use. TMC435 capsule is taken once daily in addition to 2 TVR placebo tablets 3 times a day for 12 weeks, and peginterferon alfa-2a and ribavirin for 48 weeks.
16188078|NCT01485991|Drug|TVR|TVR Type=exact number, unit=mg, number=375, form=tablet, route=oral use. TMC435 placebo Form=capsule, route=oral use. 2 TVR tablets are taken 3 times a day together with 150 mg TMC435 placebo capsule once daily for 12 weeks, in addition to peginterferon alfa-2a and ribavirin for 48 weeks
16188079|NCT01485978|Drug|Ramipril|Ramipril (Delix) tablets containing 2.5 mg ramipril, oral application with 1 to 6 mg per body surface area ramipril once daily for 3 years.
16188080|NCT01485978|Drug|placebo to ramipril|Oral application of placebo to ramipril, once daily with 1 to 6 mg per body surface area for 3 years or until disease progression.
16188081|NCT01485978|Drug|Ramipril|Oral treatment with 1 to 6 mg per body surface area ramipril once daily for 3 years as per protocol.
16188082|NCT01485965|Drug|SEN0014196|100 mg, immediate release tablets, once daily administration
16188083|NCT01485952|Drug|SEN0014196 (Low Dose)|10 mg once daily administration (immediate release capsule)
16188084|NCT01485952|Drug|SEN0014196 (High Dose)|100 mg once daily administration (immediate release capsule)
16188085|NCT01485952|Drug|Placebo|Once daily administration (immediate release capsule)
16188086|NCT01485939|Other|placebo patch applied|Patients in this group would applied the placebo patch after laparoscopic cholecystectomy.
16188087|NCT01485939|Other|5% lidocaine patch|Patients in this group would applied the 5% lidocaine patch after laparoscopic cholecystectomy.
16188088|NCT01485926|Drug|Docetaxel, Carboplatin and Trastuzumab|6 cycles q3weekly Docetaxel (75mg/m²) + Carboplatin (AUC 6) + Trastuzumab 8 mg/kg on day 1 (loading dose) and 6mg/kg for subsequent cycles, q3weekly thereafter. Patients will be scheduled for surgery and will continue to receive Trastuzumab post-operatively 6 mg/kg for one year from 1st dose of Trastuzumab.
16188089|NCT01485926|Drug|Docetaxel, Carboplatin, Trastuzumab and Lapatinib|6 cycles q3weekly Docetaxel (75mg/m²) + Carboplatin (AUC 6) + Trastuzumab (8 mg/kg on day 1 (loading dose) and 6mg/kg for subsequent cycles, q3weekly thereafter.) + Lapatinib (1000mg daily) until 1 week prior to surgery. Patients will be scheduled for surgery and will continue to receive Trastuzumab post-operatively 6 mg/kg for one year from 1st dose of Trastuzumab.
16188090|NCT01485913|Other|intensive education intervention using a network of involved diabetic patients (peer educators)|the purpose of this methodology is to set up coordinated training and education activities targeting populations with diabetes based on a pragmatic approach (the learning nests methodology) of appropriation and construction of knowledge that takes into account the individual, social, economic, cultural context. This work is being implemented on the basis of group modules specifically designed in their running: are studied the concrete elements of knowledge to mobilize, patients' actions, the role of health the educator, indicators of progress and monitoring during sessions and on the long term. Each patient is gotten to consider the elements involved in his/her disease, and the actions that can be achieved taking into account the feasibility in his/her own context. The education monitoring is envisaged through a data compendium present in the individual booklets that are given to patients at the end of each education session.
16188091|NCT01485900|Drug|SAR407899A|"Pharmaceutical form:capsule
~Route of administration: oral"
16188092|NCT01485887|Drug|Venlafaxine ER|Treatment phase: 10 months (75-225 mg/day), oral administration Tapering phase: 1-3 weeks (stepwise dose reduction: 150-37.5 mg/day), oral administration
16188093|NCT01485874|Drug|Doxil (Pegylated Liposomal Doxorubicin)|Phases I and II: 40 mg/m2 IV over 60 min (+/- 15 min) on day 1 of 28-day cycle
16188094|NCT01485874|Drug|BIBF 1120|"Phase I: Escalating cohorts days -2 through +2, orally 100mg bid, 150mg bid, 200mg bid
~Phase II: MTD orally, bid, day 2 of 28-day cycle"
16188095|NCT01485861|Drug|Abiraterone|Orally once daily
16188096|NCT01485861|Drug|Apitolisib|Orally once daily
16188097|NCT01485861|Drug|Ipatasertib|Orally once daily
16188098|NCT01485861|Drug|Placebo|Orally once daily
16188099|NCT01485861|Drug|Prednisone|Orally bid
16188100|NCT01485861|Drug|Prednisolone|Orally bid
16188101|NCT01485848|Drug|EP-100|Pharmaceutical form:Solution Route of administration: Intravenous
16188102|NCT01485848|Drug|Paclitaxel|Pharmaceutical form:Solution Route of administration: Intravenous
16188174|NCT01485341|Dietary Supplement|rice starch|rice starch is administered once a day at 10 g/day for 15 days
16188103|NCT01485835|Drug|Ganetespib|Standard 3+3 design to determine the maximum tolerated dose (MTD) of ganetespib when given in combination with bortezomib and dexamethasone.
16188104|NCT01485835|Drug|Bortezomib|Standard 3+3 design to determine the maximum tolerated dose (MTD) of ganetespib when given in combination with bortezomib and dexamethasone.
16188105|NCT01485835|Drug|Dexamethasone|Standard 3+3 design to determine the maximum tolerated dose (MTD) of ganetespib when given in combination with bortezomib and dexamethasone.
16188106|NCT01485822|Procedure|Trabecular Meshwork Tissue Collection|A minimum of two punches were used to remove tissue to form a sclerostomy. Tissue removed by the punch was collected for analysis. Alternatively, the tissue was collected by block excision of the meshwork with scissors at the time of sclerostomy.
16188107|NCT01485822|Drug|Travoprost 0.004% ophthalmic solution|
16188108|NCT01485809|Drug|Gefitinib|Gefitinib 250mg/day, oral daily q every 4 weeks
16188109|NCT01485796|Biological|Immune Globulin Infusion (Human), 10%|Subcutaneous administration will be used in Study Epochs 1 and 2.
16188110|NCT01485796|Biological|Recombinant human hyaluronidase|rHuPH20 will be administered subcutaneously (SC) immediately before each SC IGI, 10% infusion, through the same needle, at a rate of 1 to 2 mL/min.
16188111|NCT01485770|Drug|ADX-N05|150 mg once a day for seven days followed by 300 mg once a day for seven days
16188112|NCT01485770|Drug|Placebo|Placebo to match ADX-N05 once a day for 2 consecutive weeks
16188113|NCT01485757|Drug|L-arginine|All study subjects will be treated with a 12 week (11-13 week) course of oral L-arginine at a dose of 6 g per day, divided into morning and evening doses of 3 g (3 1000 mg capsules or caplets).
16188114|NCT01485744|Drug|LDE225; Fluorouracil; Leucovorin; Oxaliplatin; Irinotecan|LDE225 200-800 mg daily orally. Fluorouracil 2400 mg IV every other week. Irinotecan 180 mg/m2 IV every other week. Oxaliplatin 85 mg/m2 IV every other week. Leucovorin 400 mg/m2 IV every other week.
16188115|NCT01485731|Drug|Nelfinavir|Nelfinavir (NFV) will be prescribed orally twice daily for 7 days prior to initiation of cisplatin and pelvic radiation at the starting dose level, 875 mg BID
16188116|NCT01485731|Drug|Cisplatin|Cisplatin at 40 mg/m2 (maximum total dose of 70 mg per week), will be infused intravenously once per week on either Day 1, 2, 3, 4, or 5 of weeks 2 to 6, preferably approximately four hours prior to radiation therapy. One additional cycle of cisplatin will be given either week 7 or 8 for a total of 6 cycles of cisplatin. Patients are not to be dosed more than 70 mg/week.
16188117|NCT01485731|Radiation|Pelvic External Beam Radiation Therapy|Pelvic external beam radiation therapy (PEBRT) will be delivered in combination with weekly IV cisplatin (40mg/mg2) and twice daily oral NFV.PEBRT should be delivered once each day during the business week (Monday to Friday) according to the acceptable standards of care as prescribed by the treating radiation oncologist(s). The radiation therapy should consist of whole pelvic external beam radiation therapy (WPEBRT) with or without a parametrial boost (PB). PEBRT will be interdigitated with one administration of intrauterine brachytherapy (BT) given on any business day of week 7 or 8.
16188118|NCT01485731|Radiation|Brachytherapy|PEBRT will be interdigitated with one administration of intrauterine brachytherapy (BT) given on any business day of week 7 or 8.
16188119|NCT01485731|Procedure|Pharmacokinetic Sampling|Serum levels of Nelfinavir will be assayed at the following 3 time points: 5-8 days after initiation of NFV single agent (on Day 5, 6, or 7 of week 1 or day 1 of week 2), 1 week after combined NFV and cisplatin pelvic radiation (on day 15, 16, or 17 if start on Monday) for measurement of steady state, and at the completion of treatment (within the last 3 days of radiation in week 6). Blood samples will be taken before drug administration on the day of the sample to make sure the concentrations are actually at a minimum and before tumor biopsies.
16188120|NCT01485731|Procedure|Cervical Biopsy|Three punch biopsies of cervical tumor will be obtained during office visit at each time point (for PCR, IHC, and banked for future research). NFV serum levels will be obtained once NFV has been started (day 5-8 pre chemoradiation and at completion of chemoradiation) before each cervical biopsy
16188121|NCT01485731|Procedure|Pelvic Examination|Pre-Treatment, at the end of treatment +/- 1 week, every 3 months +/- 2 weeks after therapy (x 1 year)
16188122|NCT01485731|Procedure|Pap Smear|Recommended. Every 3 months +/- 2 weeks after therapy (x 1 year)
16188123|NCT01485731|Procedure|Audiogram|Required in patients with history of hearing loss; 28 days within starting treatment and every other cycle.
16188124|NCT01485731|Procedure|Proctoscopy|Optional. Pre-Treatment
16188125|NCT01485731|Procedure|Cytoscopy|Optional. Pre-Treatment
16188126|NCT01485731|Procedure|Renal Ultrasound|Optional. Pre-Treatment
16188127|NCT01485731|Procedure|CT Scan|CT Scan of Chest/Abdomen/Pelvis, pre-treatment,Immediately at end of trial +/- 1 week, Every 3 months +/- 2 weeks after therapy (x 1 year)
16188128|NCT01485731|Procedure|Whole Body PET/CT Scan|In lieu of CT Scan, pre-treatment,Immediately at end of trial +/- 1 week, Every 3 months +/- 2 weeks after therapy (x 1 year)
16188129|NCT01485718|Dietary Supplement|Glucomannan|Participants in the glucomannan arm will receive glucomannan 2 capsules 30 minutes before the three largest meals of the day for 12 weeks
16188130|NCT01485718|Dietary Supplement|Placebo|Participants in the placebo arm will receive placebo 2 capsules 30 minutes before the three largest meals of the day.
16188131|NCT01485705|Other|Retrospective examination by experts whether care given fo child admitted at the ICU for suspicion of bacterial infection (not nosocomial) was optimal or not|"When child is admitted at Intensive Care Unit (ICU) for suspicion of bacterial infection that is not nosocomial, data on child's infection and cares received, is completed on an electronic Case Report Form (e-CRF) by Doctor of ICU. Characteristic optimal or not of initial medical care is then determined by the independent experts blinded from issue of the care."
16188132|NCT01485692|Drug|haloperidol+promethazine|haloperidol, 2,5mg plus promethazine,25mg, intramuscular injection after baseline measures of agitation, could be repeated twice, if necessary, in the 90 minutes period of observation
16188133|NCT01485692|Drug|haloperidol + midazolam|haloperidol, 2,5mg plus midazolam, 7,5 mg, intramuscular injection after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes period of observation
16188134|NCT01485692|Drug|olanzapine|olanzapine, 10mg, intramuscular injection, after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes of observation
16188175|NCT01485328|Drug|AMARGOL®|per oral solution, 40 mL single dose
16192925|NCT01450020|Other|survey administration|Ancillary studies
16188135|NCT01485692|Drug|Ziprasidone|ziprasidone, 10 mg, intramuscular injection after baseline measures of agitation, could be repeated twice, if necessary, between the 90 minutes period of observation
16188136|NCT01485679|Other|18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography|18 fluoro-deoxy-glucose positrons emission tomography combined with computed tomography
16188137|NCT01485666|Other|Percutaneous Lead Management Kit|A kit of commercially available components to be used for HeartMate II driveline exit site cleaning, dressing and stabilization
16188138|NCT01485653|Drug|Mepivacaine|Group 1) 20mL 1.5% mepivacaine, one dose Group 2) 30mL 1.5% mepivacaine, one dose
16188139|NCT01485640|Drug|Lurasidone|Lurasidone flexibly dosed; doses of 20, 40, 60 or 80 mg/day will be taken orally with food
16188140|NCT01485627|Behavioral|Communication training and coaching|Oncologists will receive communication training. Patients will be coached to make the most of the oncologist visit.
16188141|NCT01485614|Drug|Sitagliptin|Sitagliptin 100 mg tablet administered orally once daily
16188142|NCT01485614|Drug|Metformin|Metformin 500 mg tablets administered orally starting at 500 mg/day and uptitrated by 500 mg every week to a final dose of 1000 mg twice daily
16188143|NCT01485614|Drug|Placebo to sitagliptin|Matching placebo to sitagliptin 100 mg tablet administered orally once daily
16188144|NCT01485614|Drug|Placebo to metformin|Matching placebo to metformin 500 mg tablets, 2 tablets administered orally twice daily
16188145|NCT01485614|Drug|Glycemic Rescue 1|Participants in the sitagliptin arm who require glycemic rescue will receive metformin during Weeks 0-20 and Weeks 20-54. Participants in the placebo arm who require glycemic rescue will receive metformin during Weeks 0-20. Participants in the placebo arm who have switched to metformin during Weeks 20-54 and require glycemic rescue will receive sitagliptin.
16188146|NCT01485614|Biological|Glycemic Rescue 2|Participants who require glycemic rescue after Glycemic Rescue 1 will receive open-label insulin. Participants on background insulin therapy will have the dose of their background insulin up-titrated.
16188147|NCT01485601|Biological|MT10109|Single dose intramuscular injection MT10109 vs Botox®
16188148|NCT01485588|Drug|hI-con1™ 60µl|Phase 1: 60µl, 150µl, or 300µl per injection (in the eye) on Day 1 only
16188149|NCT01485588|Drug|hI-con1™ 150µl|Phase 1: 60µl, 150µl, or 300µl per injection (in the eye) on Day 1 only
16188150|NCT01485588|Drug|hI-con1™ 300µl|Phase 1: 60µl, 150µl, or 300µl per injection (in the eye) on Day 1 only
16188151|NCT01485575|Procedure|Use of intraoperative filters in vitrectomy|During vitrectomy with xenon endoillumination, an orange, green and a yellow filter are applied sequentially to determine which one produces the best contrast behavior of vital dyes
16188152|NCT01485562|Drug|Misoprostol|4 tablets of 200 mcg misoprostol administered sublingually if the woman experiences a PPH after child birth
16188153|NCT01485562|Other|placebo|4 tablets, administered sublingually if the woman experiences a PPH
16188154|NCT01485536|Drug|AUY922|Starting Dose: 70 mg/m2 by vein on days 1, 8, 15, and 22 days of a 28 day cycle.
16188155|NCT01485523|Other|Nasal provocation test|"TPNC to dust mite has an interest in the diagnosis of allergic rhinitis to dust mites when there remains a doubt due to the poly sensitization of the patient, or the lack of specific symptoms and / or the variability of the allergic symptoms during the year. However, this test has not completely validated with a study including a significant number of patients. That's why we plan a prospective single-center comparative open study with the main objective is to determine the sensitivity and specificity of conventional nasal provocation test (TPNC) in 120 patients of 18 to 65 years old with allergic rhinitis sensitized to dust mites and patients with allergic rhinitis not sensitized to dust mites. Our secondary objective is to compare the TPNC a faster TPN-called minute (60 minutes) and which allow a wider use. If we demonstrate the validity of TPN then it would become the gold standard needed to decide on a desensitisation to mites."
16188156|NCT01485510|Behavioral|GIFT|An attachment-based assessment, then a tailored intervention aimed at maximising the chances of a maltreated child returning to the birth family.
16188157|NCT01485510|Behavioral|FACS|A social work assessment of family functioning that makes recommendations regarding future placement of a maltreated child.
16188158|NCT01485497|Device|3D endoscopic Fourier Domain OCT|Evaluation of Obstructive Sleep Apnea
16188159|NCT01485484|Device|Optic imaging use near-infrared trans-illumination methods|Optic imaging use near-infrared trans-illumination methods
16188160|NCT01485471|Device|Diffuse optical spectroscopy imaging|ear exam imaging
16188161|NCT01485458|Procedure|Early surgery|Surgery within 24 hours after admission
16188162|NCT01485458|Procedure|Delayed surgery|Surgery more than 2 weeks after injury
16188163|NCT01485445|Drug|Fluticasone Furoate (200mcg unit strength)|inhalation powder
16188164|NCT01485445|Drug|Fluticasone Furoate/Vilanterol (200/25mcg unit strength)|inhalation powder
16188165|NCT01485432|Device|PiCCO® Monitoring|Fluid and vasopressor management according to PiCCO measurements
16188166|NCT01485406|Biological|Pneumococcal vaccine GSK2830930A|1 dose administered intramuscularly
16188167|NCT01485406|Biological|Synflorix™|1 dose administered intramuscularly
16188168|NCT01485393|Drug|Dexmedetomidine|A dose of dexmedetomidine will be administered at 1mcg/kg over 10 minutes. Subjects will never receive active drugs (Zolpidem or dexmedetomidine concurrently).
16188169|NCT01485393|Drug|Zolpidem|12.5 mg of oral Ambien CR. Subjects will never receive active drugs (Zolpidem/Ambien or dexmedetomidine concurrently).
16188170|NCT01485380|Drug|dexmedetomidine|The dexmedetomidine infusion will be individualized to each study participant by a target plasma concentration where loss of consciousness is initially observed. Loss of consciousness will be assayed by specific auditory and verbal stimuli.
16188171|NCT01485367|Drug|adapalene gel 0.3%|A pea size drop of Adapalene gel 0.3% will be applied to the odd numbered subjects on the left dorsal hand & extensor forearm. A pea size drop of Adapalene gel 0.3% will be applied to the even numbered subjects on the right dorsal hand & extensor forearm. The randomized area will be cleansed with Cetaphil Gentle Cleanser before applying the study medication. All subjects will apply sunscreen with zinc oxide in the morning to both the right & left forearms.
16188172|NCT01485354|Device|Armeo Spring training|Upper-limb training using the Armeo system for a period of 6 weeks
16188173|NCT01485341|Dietary Supplement|gluten|gluten is administered once a day at 10g/day for 15 days
16188176|NCT01485315|Biological|SAGM (Saline-Adenine-Glucose-Mannitol) blood transfusion|One unit prestorage, leuko-depleted SAGM blood at haemoglobin at 9.0 g/dl (5.6 mM) or less at point-of-care testing
16188177|NCT01485315|Biological|SAGM (Saline-Adenine-Glucose-Mannitol) blood transfusion|One unit prestorage, leuko-depleted SAGM blood at haemoglobin 7.0 g/dl (4.3 mM) or less at point-of-care testing
16188178|NCT01485302|Drug|SAR228810|"Pharmaceutical form:solution
~Route of administration: intravenous"
16188179|NCT01485302|Drug|SAR228810|"Pharmaceutical form:solution
~Route of administration: subcutaneous"
16188180|NCT01485276|Procedure|DBS Surgery|
16188181|NCT01485237|Other|We will compare the resources used by both groups|The main purpose of this study is to review the resource utilization. Secondary objectives include, comparison of resource utilization to other similar disorders (viral pneumonia, bacterial pneumonia, septic shock, ARDS). We will also look at the percentage of patients that required ICU care as compared to those who could be cared for on medical wards. We will determine the resources used by both groups and compare. Finally we will record the frequency of chronic comorbidities in hospitalized adult H1N1 patients.
16188182|NCT01485224|Drug|Thalidomide|"Eligible patients will receive thalidomide at a starting dose of 50 mg/day by mouth at bedtime for 4 weeks. In the event of unsatisfactory/no response, thalidomide dosage will be progressively increased by 50 mg/day every 4 weeks until complete or partial response, to a maximum dose of 200 mg/day.
~Treatment will be continued until one of the following criteria is met:
~8 additional weeks of treatment after the achievement of complete response
~16 additional weeks of treatment after the achievement of partial response
~24 weeks of treatment completed without response
~unacceptable toxicity. Then, patients will be followed off of thalidomide for 24 weeks."
16188183|NCT01485211|Drug|cross-linking with hypo-osmolar riboflavin|Hipo-osmolar riboflavin was applied every 20 seconds until the TCT reached 400µm. UVA irradiation was performed for 30 min. Pachymetry was recorded at the thinnest point of the cornea preoperatively, after epithelial removal, after iso-osmolar riboflavin, after hypo-osmolar riboflavin, after UVA irradiation, and at 1, 6 and 12 months.
16188184|NCT01485198|Procedure|Bone Marrow Autologous Stem Cells Infusion|Extraction and knee infusion of Bone Marrow Autologous Stem Cells
16188185|NCT01485198|Drug|Acetaminophen|Acetaminophen (750mg orally TID) administration
16188186|NCT01485185|Drug|Gabapentin lower dose|Repeat, oral dose
16188187|NCT01485185|Drug|Donepezil|Repeat, oral dose
16188188|NCT01485185|Other|Placebo (Dop)|Placebo to donepezil, Repeat, oral dose
16188189|NCT01485185|Other|Placebo (Gaba)|Placebo to gabapentin, Repeat, oral dose
16188190|NCT01485185|Drug|Gabapentin higher dose|Repeat, oral dose
16188191|NCT01485172|Drug|ropinirole monotherapy|ropinirole as monotherapy in Parkinson's disease
16188192|NCT01485172|Drug|placebo monotherapy|placebo as monotherapy in Parkinson's disease
16188193|NCT01485159|Procedure|Spirometry|assessment of lung function by spirometry
16188194|NCT01485146|Drug|ETC-1002|escalating doses
16188195|NCT01485120|Device|BP monitoring using two methods|BP readings from participant using invasive radial arterial line, Non-invasive cuff with SuperSTAT NIBP algorithm, and Non-invasive cuff with Classic NIBP algorithm.
16188196|NCT01485107|Device|Ulthera® System|Focused ultrasound energy delivered below the surface of the skin.
16188197|NCT01485094|Drug|GRT6010|Oral solution given once daily.
16188198|NCT01485094|Drug|Pregabalin|Over-encapsulated pregabalin capsules 75mg twice daily on Days 1 to 3, and 150mg twice daily on Days 4 to 7.
16188199|NCT01485094|Drug|Matching Placebo|"Matching Placebo capsules to the over-encapsulated Pregabalin capsules and Matching Placebo oral solution to the GRT6010 solution.
~Capsules twice daily on Days 1 to 7. Solution once daily."
16188200|NCT01485081|Device|Danubio paclitaxel-eluting balloon|Inflation of the Danubio Paclitaxel Eluting Balloon in the side branch of a de novo bifurcation lesion.
16188201|NCT01485068|Device|Danubio paclitaxel-eluting balloon|Inflation of the Danubio Paclitaxel Eluting Balloon in in-stent restenosis lesions.
16188202|NCT01485055|Drug|Infliximab and Basiliximab|"Participants in this research study will receive combination therapy (2 drugs: Infliximab and Basiliximab)once a week for four weeks. Both drugs will be given through the participant's broviac, port or through a vein in the arm. It will take about 4-5 hours to complete the 2-drug combination therapy each week. Participants will be given pre-medications to help prevent reactions to the study drugs.
~Infliximab will be given at a dose of 10mg per Kg per dose. Basiliximab will be given in 10mg doses to patients who weigh less than 35kg. Patients who weigh weigh more than 35kg will receive 20mg doses. Patients will receive both drugs weekly on days 1,8,15 and 22. Each drug will be given 4 times."
16188203|NCT01485042|Drug|Pazopanib and TH-302|Pazopanib 800 mg daily TH-302 IV on Days 1, 8, 15 at MTD Subjects will receive this regimen until disease progression.
16188204|NCT01485029|Procedure|Nasopharyngeal (NP) aspirate|Nasopharyngeal (NP) aspirate with a small flexible canule to obtain NP swabs
16188205|NCT01485003|Biological|natalizumab|Natalizumab will not be provided as a part of this study. Participants will receive natalizumab as prescribed by their treating physician.
16188206|NCT01484990|Drug|Levodopa-Carbidopa|Intestinal Gel
16188207|NCT01484977|Drug|Lacosamide|"50 mg and 100 mg lacosamide tablets will be combined and taken in two equal doses per day to provide the required total daily dosage of 100 - 600 mg/day. Subjects were titrated to a minimum of 200 mg/ day during the Treatment Period.
~Maximum duration of study drug administration is approximately 23 weeks."
16188208|NCT01484964|Drug|ASP015K|oral
16188209|NCT01484951|Drug|Brinzolamide 1% and timolol 0.5% fixed combination eye drops|
16188210|NCT01484938|Device|OPTI-FREE PureMoist|Commercially marketed multi-purpose contact lens solution for cleaning, rinsing, disinfecting/storing, and reinserting contact lenses
16188211|NCT01484912|Drug|STA-2|"After 1 week of screening and washout, patients who met the entry criteria were randomly assigned either to the treatment or control group. The regimen of STA-2 was:
~STA-2 250 mg capsule, each containing 100 mg green tea polyphenols, 2 capsules t.i.d. (three times a day) for 6 weeks, to be administered in a non-fasting state."
16188212|NCT01484912|Drug|Placebo|"After 1 week of screening and washout, patients who met the entry criteria were randomly assigned either to the treatment or control group. The regimen of Placebo was:
~Placebo 250 mg capsule, 2 capsules t.i.d. (three times a day) for 6 weeks, to be administered in a non-fasting state."
16188213|NCT01484886|Other|Red blood cell transfusion|10cc/kg weight RBC transfusion as needed according to hemoglobin level
16188214|NCT01484886|Other|Red blood cell transfusion|10cc/kg body weight RBC will be transfused for hemoglobin under 9.5 for biventricular repairs and under 12 for single ventricle palliations.
16188215|NCT01484873|Drug|Exenatide|Treatment with exenatide 5 mcg twice daily for 4 weeks, then 10 mcg twice daily for 46 weeks.
16188216|NCT01484860|Drug|AUY922|AUY922 is a solution for intravenous administration Dose: 70 mg/m2 over 1 hour, weekly
16188217|NCT01484847|Drug|PF-00299804|Tablet, single dose of 45 mg via gastrojejunostomy tube (G-Tube) on an empty stomach
16188218|NCT01484834|Behavioral|Exercise and Education|"Exercise were prescribed three times a week with duration of fifteen minutes for three months.
~Educational Intervention were composed by a quality of life computer software and poster with tips on health behaviors"
16188219|NCT01484834|Behavioral|Exercise|Exercise were prescribed three times a week with duration of fifteen minutes for three months.
16188220|NCT01484834|Behavioral|Educational Intervention|This company received a quality of life software and poster intervention with tips on health lifestyle. The posters were printed in A3 paper and eight of them were put up per month in different parts of the companies (near water fountains, rest places, cafeterias, near the restrooms and change rooms). The used messages, both by the posters and the software were basedon scientific evidence related to quality of life and health
16188221|NCT01484834|Other|Control Company|No intervention was applied for the participants of this group
16188222|NCT01484821|Device|ARFI|Muscle sonoelastography using ARFI(Acoustic Radiation Force Impulse) imaging
16188223|NCT01484795|Device|BILEVEL (Respironics)|Bilevel was delivered by a Bipap® ventilator (Respironics Inc, Murrysville, PA), applied via facial mask, with inspiratory positive pressure (IPAP) of 20 cmH2O and expiratory positive airway pressure (EPAP) of 10 cmH2O.
16188224|NCT01484795|Device|Continuos positive airway pressure (Respironics)|CPAP was delivered by a ventilator (Respironics Inc, Murrysville, PA), applied via a facial mask, with expiratory positive airway pressure of 10 cmH2O.
16188225|NCT01484782|Behavioral|Interactive Voice Response (IVR) automated calls|Interactive Voice Response (IVR) is a type of automated telephone call. Weekly automated telephone assessment and behavior change calls focused on blood pressure management will be sent to the experimental group. They will receive a weekly 10-minute automated phone call to their telephone for disease assessment and self-care support for 6 weeks. In-home blood pressure cuffs were provided for measurement of blood pressure throughout the study.
16188226|NCT01484756|Dietary Supplement|daily multi micronutrient supplement|Multi micro-nutrient supplement tablet containing 40 mg elemental zinc (as gluconate, 120 mg ascorbic acid, 6 mg beta-carotene, 15 mg alpha-tocopherol (as d-alpha-tocopheryl acid succinate, 400 micrograms folic acid in experimental group given daily for six months
16188227|NCT01484756|Dietary Supplement|Placebo|calcium carbonate 500 mg
16188228|NCT01484743|Procedure|differences in surgical techniques|follow the risk for morbidity after incisional hernia repair
16188229|NCT01484730|Device|Multi-Spectral & Laser Speckle Imaging|Changes in skin tissue and blood flow.
16188230|NCT01484717|Behavioral|contingency management for smoking abstinence|Participants earn the chance to win prizes for breath samples that test negative for cigarette smoking.
16188231|NCT01484717|Drug|transdermal nicotine|Participants receive an 8 week supply of transdermal nicotine [21 mg patches (4 wks), 14 mg (2 wks), 7 mg (2 wks)].
16188232|NCT01484717|Behavioral|Telephone counseling|Participants receive brief twice weekly telephone counseling.
16188233|NCT01484691|Drug|Budesonide|Inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks
16188234|NCT01484665|Other|PROCASE Decision-Aid|"VA health services researchers have developed a patient education pamphlet for prostate cancer screening. The pamphlet, titled The PSA test for prostate cancer: Is it Right for ME was created by members of the PROstate CAncer Screening Education (PROCASE) study team. A modified version of the PROCASE decision aid will be utilized in this study."
16188235|NCT01484652|Drug|COV795|2 tablets taken every 12 hours
16188236|NCT01484652|Drug|Placebo|2 tablets taken every 12 hours
16188237|NCT01484639|Other|Liberal transfusion triggers|"Patients allocated to a liberal transfusion strategy will receive red cell transfusion if their hemoglobin concentration is 95 g/L or less intraoperatively and postoperatively in the intensive care unit, and less than 85 g/L on the ward."
16188238|NCT01484639|Other|Restrictive transfusion triggers|"Patients allocated to a restrictive transfusion group will receive a red cell transfusion if their hemoglobin is 75 g/L or less intraoperatively and postoperatively."
16188239|NCT01484626|Drug|Bendamustine|The first group of three patients to enter the study will receive a 25 mg/m^2 dose of bendamustine. If this dose is found to be safe, the next three patients will receive 50 mg/m^2. Using a modified Fibonacci dose-escalation design, the dose will continue to increase at a rate of 25 mg/m^2 until the highest safe dose of bendamustine is found. The maximum dose will be 125 mg/m^2. Bendamustine and bortezomib will be given through a catheter twice a week every 21 days. Dexamethasone and lenalidomide will be given orally. In general, a cycle of chemotherapy will last 21 days.
16188240|NCT01484613|Device|quadripolar LV lead (Quartet)|All participants will receive CRT-D system with a quadripolar lead. This lead offers 10 LV lead vectors to choose from
16188241|NCT01484600|Drug|REGN668: Injection Rate 1|Subjects will receive REGN668 via SC injection
16188242|NCT01484600|Drug|REGN668: Injection Rate 2|Subjects will receive study drug via alternate delivery (if necessary)
16188243|NCT01484587|Drug|CNTO 1959|CNTO 1959: type=range, unit=mg, number=10, 30, 100, 300, form=solution for injection, route=subcutaneous use, ascending dosing for 24 weeks
16188244|NCT01484587|Drug|Placebo|Placebo: form=solution for injection, route=subcutaneous use, ascending dosing for 24 weeks
16188245|NCT01484574|Biological|Allogeneic Mesenchymal Stem Cells|Single intramuscular administration of low dose of stem cells
16188246|NCT01484574|Biological|Allogeneic Mesenchymal Stem Cells|Single intramuscular administration of intermediate dose of stem cells
16188247|NCT01484561|Drug|CP-690,550 or Placebo|CP-690,550 10 mg twice a day (BID) orally or placebo BID orally, approximately 72 days
16188248|NCT01484561|Drug|Placebo|Placebo BID orally, approximately 72 days
16188249|NCT01484548|Biological|LEISH-F3 + GLA-SE|20 ug of LEISH-F3 and 2 ug of GLA-SE adjuvant. 3 injections at Days 0, 28, and 56.
16188250|NCT01484548|Biological|LEISH-F3 + GLA-SE|20 ug of LEISH-F3 and 5 ug of GLA-SE adjuvant. 3 injections at Days 0, 28, and 56.
16188251|NCT01484548|Biological|LEISH-F3 alone|20 ug of LEISH-F3 antigen alone. 3 injections at Days 0, 28, and 56.
16188252|NCT01484535|Procedure|Ankle Aspiration|Ankle aspiration will be performed through either a standard anterolateral or anteromedial approach, depending on the conditions of the soft tissue. The anterolateral approach will be the preferred method due to the higher reproducibility of intra-articular needle placement. The anteromedial approach will be reserved for patients whose soft tissues over the anterolateral portal are compromised. Sterile preparation of the limb will be achieved with the use of chlorhexidine or Betadine. An 18 gauge needle will be introduced into the ankle joint and a syringe will be used to aspirate the ankle until no more hemarthrosis is able to be removed. The amount of hemarthrosis aspirated will be recorded. Following the procedure, care will continue as per standard of care.
16188253|NCT01484535|Procedure|Ankle aspiration Standard Anterolateral|Placebo ankle aspiration will be performed through a standard anterolateral. Sterile preparation of the limb will be achieved with the use of chlorhexidine or Betadine. An 18-gauge needle will be introduced into the skin. The needle will be held in the skin for 5-10 seconds in an effort to simulate the pain and time-lag experienced with aspiration. The needle will not pass the fascia or ankle joint capsule. Following the procedure, care will continue as per standard of care.
16188254|NCT01484522|Biological|FluMist|Administered at the manufacture's recommended dose
16188255|NCT01484522|Biological|Fluvirin|Vaccine administered at the manufacturer's recommended dose.
16188256|NCT01484522|Biological|Fluzone|Vaccine administered at manufacturer's recommended dose
16188257|NCT01484496|Biological|Placebo|Placebo
16188258|NCT01484496|Biological|Belimumab 200 mg SC|Belimumab 200 mg SC
16188259|NCT01484496|Drug|Standard therapy|Standard therapy comprises any of the following (alone or in combination): corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and immunosuppressives; biologics and intravenous cyclophosphamide are not permitted.
16188260|NCT01484470|Biological|StemEx|"For patients allocated to StemEx® arm:
~Day -20: Start small (or equal) portion expansion at processing site. (II) Conditioning Phase
~Day -6 to -1: Subject receives a RIC regimen containing Fludarabine, Cyclophosphamide and Total Body Irradiation (TBI) (III) Transplantation and Follow-up Phase
~Day 0: CBU unmanipulated portion transplantation (for StemEx® arm) or unmanipulated CBU transplantation.
~Day 1: StemEx® transplantation.
~Day 2 to 3 years: Post transplant follow-up."
16188261|NCT01484457|Device|Closed-loop session|"Subjects will arrive fasting at 7am unless needed for hypoglycemia (glucose < 70 mg/dL) and no extra bolus insulin after 3am. An IV catheter will be inserted for blood samples and for IV administration of glucose if necessary. Blood samples will be analyzed for glucose by YSI 2300Stat every 30 minutes.
~Breakfast consisting of 25g of CHO will be eaten at 7:30 am and the subject will bolus for this amount of CHO. The controller is switched on on the down slope of the meal response, and the subject is brought to a basal steady-state by the controller. Target blood glucose is 110 ± 30-mg/dL.
~After approximately 3 hours a small lunch will be eaten consisting of 25g of CHO (unannounced meal challenge). The subject will be monitored until blood glucose returns to euglycemia."
16188262|NCT01484431|Drug|Tadalafil- Tablet or Oral suspension|Tadalafil Tablets administered orally. Tadalafil Oral suspension: An aqueous, ready-to-use suspension for oral administration.
16188263|NCT01484418|Behavioral|Exposure in vivo|5-10 sessions based on an individualized fear hierarchy
16188264|NCT01484418|Behavioral|Cognitive Behavioural Psychotherapy|graded activity, relaxation techniques and cognitive interventions
16188265|NCT01484405|Procedure|posterior approach|Surgical approach for Total Hip Arthroplasty
16188266|NCT01484405|Procedure|anterolateral approach|anterolateral surgical approach
16188267|NCT01484379|Procedure|unilateral neck exploration|All elderly patients with primary hyperparathyroidism suspected to have a single gland disease will have a unilateral neck exploration following the index gland identification.
16188268|NCT01484366|Procedure|intramedullary nailing and plating|Surgical intramedullary nailing of the ulna and plating of the radius
16188269|NCT01484366|Procedure|plating|Surgical plating of both bonforearm fractures
16188270|NCT01484353|Behavioral|Coronary Health Improvement Project Program|The Coronary Health Improvement Project' (CHIP; an intensive, community-based, lifestyle change program including a low saturated fat diet rich in whole, grown foods) has been shown to improve the health of diabetics through an intensive education taught over a 12 week period, but has not been studied in terms of its effect on HBAIC. Kaiser Permanente places significant resources into preventive medicine but does not have programs with the level of intensity of CHIP. This study aims to determine if Kaiser members with uncontrolled type 2 diabetes can achieve a significant improvement in their HBAIC after 12 weeks of participation in the CHIP program.
16188271|NCT01484340|Drug|Nicotine|"The nicotine patch be given in three phases:
~2 weeks of patches at enrollment
~6 weeks of patches at two-week follow-up visit
~2 weeks of patches at two-month follow-up visit
~This schedule will cover the entire 10-week course of therapy as per label instructions: 6 weeks at 21mg; 2 weeks at 14mg; and 2 weeks at 7mg."
16188272|NCT01484340|Behavioral|Intensive Counseling|"The advice to quit smoking message will follow NCI's 5A's model for smoking cessation counseling. This is a simple smoking cessation counseling strategy with 5 discrete components: (1) Ask about smoking at every opportunity; (2) Advise the patient to quit smoking; (3) Assess readiness to quit; (4) Assist the patient in quitting; and (5) Arrange follow-up.
~Visit schedule:
~Baseline
~2-week follow-up (Quit Day)
~1-month follow-up
~2-month follow-up
~3-month follow-up
~6-month follow-up
~Participants abstinent at 6-month follow-up will be next seen at 12-month follow-up.
~Participants still smoking at 6-month follow-up will be offered group-assigned intervention again."
16188273|NCT01484327|Drug|Carvedilol|Minimum dosage 3.125 mg Χ 2, Maximum dosage 50 mg
16188274|NCT01484314|Drug|Eltrombopag|100mg (patients of East Asian descent will receive a dose of 50mg) orally dosed once daily starting 6 days prior to initiation of chemotherapy for a total of 11 days of treatment during two consecutive cycles of chemotherapy
16188275|NCT01484288|Device|Barostim Neo System|Baroreflex Activation Therapy using the Barostim Neo System
16188276|NCT01484275|Drug|Siltuximab|Type=exact, unit=mg/kg, number=15, form=intravenous infusion, route=intravenous use, every 4 weeks until progression to symptomatic multiple myeloma, unacceptable toxicity, withdrawal of consent, or the end of the study.
16188277|NCT01484275|Drug|Placebo|Form=intravenous infusion, route=intravenous use route=intravenous, use every 4 weeks until progression to symptomatic multiple myeloma, unacceptable toxicity, withdrawal of consent, or the end of the study.
16188278|NCT01484262|Drug|liraglutide|Patients will be treated according to routine clinical practice at the discretion of the treating physician according to current labelling.
16188279|NCT01484262|Drug|insulin|Any insulin in any device available on the market may be used by patients as part of routine clinical practice according to current labelling.
16188280|NCT01484249|Device|CE Pro System|The CE Pro System consists of a delivery catheter with an integrated proximal filter intended to be deployed in the brachiocephalic artery. In addition, the device has an articulating distal tip and a through lumen to allow a commercial intravascular filter to be back-loaded into the CE Pro System and be deployed into and retrieved from the left carotid artery.
16188281|NCT01484223|Behavioral|Cognitive Behavioral Therapy|Four Cognitive behavioral group sessions. Each session will last two hours a week
16188282|NCT01484210|Drug|Elpenhaler active - Diskus placebo|randomized, double-blind, double-dummy, 2-way crossover, single dose study, comparing the efficacy and safety of the Fluticasone/Salmeterol (500/50 μg) combination administered with Elpenhaler® (Rolenium®) versus the innovative one (Seretide Diskus®) in patients with asthma.
16188283|NCT01484197|Drug|75 µg indacaterol maleate (LB)|75 µg indacaterol maleate lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
16188284|NCT01484197|Drug|75 µg indacaterol maleate (PoS)|75 µg indacaterol maleate PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.
16188285|NCT01484197|Drug|37.5 µg indacaterol maleate (PoS)|37.5 µg indacaterol maleate PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.
16188286|NCT01484197|Drug|placebo to indacaterol (LB)|Placebo to indacaterol lactose blend (LB) delivered via the Concept1 device once daily in the morning for 7 days.
16188287|NCT01484197|Drug|placebo to indacaterol (PoS)|Placebo to indacaterol PulmoSphereTM (PoS) delivered via the Concept1 device once daily in the morning for 7 days.
16188288|NCT01484184|Drug|SPINALON (buspirone + levodopa + cardidopa)|The proposed study is a combination of 1 and 2-arm designs. First, a 2-arm design will be used, the first arm being composed of 3 subjects receiving the lowest dose of the study drug, and the second arm being composed of 1 subject receiving a placebo. This 2-arm design will be repeated consecutively (not simultaneously) with increasing doses of SPINALON, as long as the dose is well tolerated. Six (6) groups are expected to be tested with this 2-arm design.This will be followed by a 2-arm composed of 1 group with 1 subject receiving placebo and 1 larger group (10 subjects) who will receive SPINALON at MTD as identified in the previous 2-arm groups.
16188289|NCT01484171|Drug|idarubicin|idarubicin 10-12 mg/m2 for three days
16188290|NCT01484171|Biological|microtransplantation|idarubicin 10-12mg/m2 for four days. After chemotherapy infusion granulocyte colony-stimulating factor-mobilized HLA-mismatched donor peripheral blood stem cells following each of three cycles of high dose cytarabine chemotherapy
16188291|NCT01484145|Drug|Terbinafine HCl|4% w/w terbinafine HCL gel, single dose,
16188292|NCT01484132|Procedure|Restoration of dental caries with dental composite|Dental Restoration (bisphenol A diglycidyl ether methacrylate based composite)
16188293|NCT01484119|Drug|ACT-129968|daily tablets
16188294|NCT01484119|Drug|Placebo|matching placebo tablets and capsules
16188295|NCT01484119|Drug|Cetirizine|daily capsules
16188296|NCT01484106|Other|Fluid Resuscitation|"In the Treatment group, this information will be used in a specific 4-hour treatment algorithm to guide fluid administration that is summarized in Figure 1. The information provided by the NICOM in response to the fluid bolus will be used to assess whether the subject is fluid responsive (FR)."
16188297|NCT01484106|Other|Standard of Care|Standard of Care
16188298|NCT01484093|Other|R-CHOP-14R-HIDAC,followed by RIT/HDT/ASCR.|INDUCTION: R-CHOP-14 CHEMOTHERAPY: 4 cycles every 2 weeks ± 1 day All patients in the study in both phases will undergo induction and consolidation with R-CHOP 14R-HIDAC, followed by RIT/HDT/ASCR. Patients will undergo restaging scans 12 to 14 days following completion of R-CHOP 14, with CT, and FDG-PET. Patients demonstrating at least a PR may proceed to consolidation with R-HIDAC. CONSOLIDATION: R- HIDAC CHEMOTHERAPY: 2 cycles every 3 weeks ± 2 days After R-HIDAC, restaging will occur 17-21 days post cycle 2 with CT scan (or FDG-PET, if this was positive following R-CHOP-14). Radioimmunotherapy Dosimetric dose is given approximately 4-5 weeks after completing cycle 2 of R-HIDAC. This is to be preferred 1 week post restaging scans 17-21 days post cycle 2 of RHIDAC, and up to 2 weeks post-scans will be acceptable only if required by 131 I Tositumomab availability.
16188299|NCT01484080|Drug|BIBF + Paclitaxel|"Priming Period:
~Oral BIBF 1120 will be administered during 2 weeks at the dose determined during the phase-I part that can be combined safely with weekly paclitaxel, on a continuous schedule for 14 days.
~One week washout is planned before starting the treatment phase.
~Treatment Phase:
~Paclitaxel 80 mg/m2 iv on days 1, 8 and 15 + BIBF 1120 recommended dose bid po days 1-21 q 21 days. (BIBF 1120 morning dose is skipped on the paclitaxel administration days)."
16188300|NCT01484080|Drug|Paclitaxel|Paclitaxel 80 mg/m2 iv on days 1, 8 and 15 q 21 days. A total of 4 cycles will be administered in both arms.
16188301|NCT01484067|Device|Patch ( Compeed© Total CareTM Cold Sore Patch)|A cold sore patch containing zinc sulfate
16188302|NCT01484054|Device|etafilcon A with print and PVP for dark eyes (EAPVPDE)|A daily disposable contact lens
16188303|NCT01484054|Device|etafilcon A control lens (EADE)|A marketed daily disposable contact lens
16188304|NCT01484041|Drug|Dovitinib|Dovitinib at the recommended Phase 2 dose for 5 consecutive days followed by a 2-day rest
16188305|NCT01484041|Drug|Aromatase Inhibitors|Patients will receive one of the aromatase inhibitors either anastrozole 1 mg po daily, letrozole 2.5 mg po daily, or exemestane 25 mg po daily
16188306|NCT01484028|Device|etafilcon A control lens (1DM)|A marketed daily disposable contact lens
16188307|NCT01484028|Device|etafilcon A with print and PVP for light eyes (EALE)|A daily disposable contact lens
16188308|NCT01484028|Device|etafilcon A with print and PVP for dark eyes (EADE)|A daily disposable contact lens
16188309|NCT01484015|Drug|cefepime hydrochloride|Given IV
16188310|NCT01484002|Device|Total hip arthroplasty|Replacement of a patient's native hip with an artificial implant featuring a metal-on-polyethylene articulation
16188311|NCT01483989|Other|SYSTANE® Gel Drop lubricant eye gel|SYSTANE Gel Drops Lubricant Eye gel dosed (bilaterally) 3 times per day for the 28 day period.
16188312|NCT01483976|Other|Oral medical nutritional supplement|orally over a three hour period
16192926|NCT01450020|Procedure|quality-of-life assessment|Ancillary studies
16188313|NCT01483976|Other|Experimental oral medical nutritional supplement with AN777|orally over a three hour period
16188314|NCT01483963|Biological|AA4500 0.29 mg/1 mL|treatment of adhesive capsulitis
16188315|NCT01483963|Biological|AA4500 0.58 mg/2 mL|treatment of adhesive capsulitis
16188316|NCT01483963|Biological|AA4500 0.58 mg/1 mL|treatment of adhesive capsulitis
16188317|NCT01483963|Biological|AA4500 0.58 mg/0.5 mL|treatment of adhesive capsulitis
16188318|NCT01483963|Other|Shoulder exercises|Home shoulder exercises, minimum of 3 times per day
16188319|NCT01483937|Device|Usual care physical therapy plus SEMD|Patients will receive usual care physical therapy while wearing SEMD. SEMD protocols will also be provided to device subjects.
16188320|NCT01483937|Other|Usual care physical therapy only|Subjects will receive usual care physical therapy from vestibular and balance specialists.
16188321|NCT01483924|Drug|Apo805K1|Sequential parallel dose escalation.
16188322|NCT01483911|Biological|ALX-0171|Single or multiple ascending doses (2.1-210 mg), administered via pulmonary inhalation. Multiple dosing will consist of twice daily dosing on 5 consecutive days.
16188323|NCT01483911|Biological|Placebo|Single or multiple doses, administered via pulmonary inhalation. Multiple dosing will consist of twice daily dosing on 5 consecutive days.
16188324|NCT01483898|Biological|Ixmyelocel-T|On Day 14, 20 intramuscular injections of ixmyelocel-T on pre-identified index leg.
16188325|NCT01483898|Other|Placebo|On Day 14, 20 intramuscular injections of vehicle control on pre-identified index leg.
16188326|NCT01483885|Device|Transcutaneous Electric Nerve Stimulation|Tens at 4Hz and 100 Hz will be delivered using TENS stimulator (Ibramed/Neurodyn-São Paulo, Brazil)
16188327|NCT01483885|Device|Interferential Current|Interferential Current (IC) at 4Hz and 100 Hz will be delivered using IC stimulator (Ibramed/Neurodyn-São Paulo, Brazil)
16188328|NCT01483885|Procedure|Manual Acupuncture|Manual acupuncture will be delivered with sterile needles for each subject in the acupoint TA5 and CS6 localized in the dominant forearm.
16188329|NCT01483872|Drug|NAC/Tigecycline/Heparin combination lock solution|
16188330|NCT01483872|Drug|Standard anticoagulant (Heparin or Citrate)|
16188331|NCT01483859|Other|preoperative liver stiffness measurement|Liver stiffness measurement (LSM) using Fibroscan is a newly introduced noninvasive tool that generates an elastic wave using a vibrator applied to the thoracic wall at the level of the right lobe of the liver and measures the prolongation velocity of the wave, which is directly associated with liver stiffness (LS).
16188332|NCT01483846|Drug|AV-101|Placebo or AV-101 at 360 mg, 1080 mg, or 1440 mg will be dosed once daily for 14 consecutive days.
16188333|NCT01483846|Drug|Placebo|Placebo or AV-101 at 360 mg, 1080 mg, or 1440 mg will be dosed once daily for 14 consecutive days.
16188334|NCT01483833|Drug|Iferanserin|Iferanserin 0.5% ointment applied intra-anally twice daily for 14 days
16188335|NCT01483833|Drug|Placebo|Placebo ointment applied intra-anally twice daily for 14 days
16188336|NCT01483820|Drug|TPI 287|Subjects will receive six cycles of intravenous (IV) TPI 287 at a dose of 125 mg/m2 on Days 1, 8 and 15 of a 21-day cycle.
16188337|NCT01483807|Behavioral|Sound Production Treatment - Blocked|Sound Production Treatment is a treatment for acquired apraxia of speech. Combines therapist modeling, simultaneous production, articulatory instruction, feedback and repeated practice. SPT-Blocked entailed practicing all treatment targets blocked by target. SPT-Random entailed practicing all treatment targets in a non predictable, random order.
16188338|NCT01483807|Behavioral|Sound Production Treatment - Random|A treatment for acquired apraxia of speech. Combines therapist modeling, simultaneous production, articulatory instruction, feedback and repeated practice. SPT-Random entailed practicing treatment targets in a non predictable order. SPT-Blocked entailed practicing treatment targets blocked by target.
16188339|NCT01483781|Drug|Canagliflozin|Type = exact number, unit = mg, number = 300, form = capsule, route = oral use. One encapsulated tablet once daily for up to approximately 85 days (approximately 12 weeks)
16188340|NCT01483781|Drug|Placebo|Form = capsules, route = oral use. One capsule once daily for up to approximately 85 days (approximately 12 weeks)
16188341|NCT01483768|Procedure|Sleeve gastrectomy for morbid obesity|Sleeve gastrectomy or longitudinal gastrectomy for morbid obesity: is a partial gastrectomy without interruption of the gastric continuity. This procedure includes the resection of the great curvature of the stomach, the fundus , except the lesser curvature and the antrum.
16188342|NCT01483755|Procedure|Postconditioning|Postconditioning consists of four cycles of one minute balloon inflation followed by one minute of balloon deflation, with the initial inflation being started within the first minute after reopening of the culprit coronary artery.
16188343|NCT01483755|Procedure|Percutaneaous intervention|Conventional primary percutaneaous intervention
16188344|NCT01483742|Drug|RO5024048|1000 mg orally bid, 24 weeks
16188345|NCT01483742|Drug|danoprevir|100 mg orally bid, 24 weeks
16188346|NCT01483742|Drug|peginterferon alfa-2a [Pegasys]|180 mcg weekly, 24 weeks
16188347|NCT01483742|Drug|ribavirin|1000-1200 mg/kg/day orally in two divided doses, 24 weeks
16188348|NCT01483742|Drug|ritonavir|100 mg orally bid, 24 weeks
16188349|NCT01483729|Drug|danoprevir|Phase 3 Tablet Formulation 1, single oral dose
16188350|NCT01483729|Drug|danoprevir|Phase 3 Tablet Formulation 2, single oral dose
16188351|NCT01483729|Drug|danoprevir|Reference Phase 2 Tablet Formulation, single oral dose
16188352|NCT01483729|Drug|ritonavir|Test Formulation 1, single oral dose
16188353|NCT01483729|Drug|ritonavir|Test Formulation 2, single oral dose
16188354|NCT01483729|Drug|ritonavir|Reference Formulation, single oral dose
16188355|NCT01483716|Behavioral|Rehabilitation|
16188356|NCT01483703|Device|Laser Speckle Imaging|Laser Speckle Imaging of Critical Care Neonates
16188357|NCT01483690|Drug|Decitabine|10 mg/m2/day given IV over 1 hour on days 1 through 5 and days 15 through 19.
16188358|NCT01483690|Drug|Vorinostat|180 mg/m2/day (Max dose=400mg daily) given orally on days 2 through 7 and days 16 through 21.
16188359|NCT01483690|Drug|Vincristine|1.5 mg/m2/day (Max dose 2 mg) given IV push on days 10, 17, 24 and 31.
16188360|NCT01483690|Drug|Dexamethasone|20 mg/m2/day divided BID given orally on days 8 through 12 and 22 through 26.
16188361|NCT01483690|Drug|Mitoxantrone|10 mg/m2/day given on days 8 and 9 as a short IV infusion over 5-15 minutes; do not infuse over less than 3 minutes
16188362|NCT01483690|Drug|Pegaspargase|2500 international units/m2/day IM or IV on days 10 and 24.
16188363|NCT01483690|Drug|Methotrexate|"Given intrathecally to all patients the dose defined by age below.
~8 mg for patients age 1-1.99
~10 mg for patients age 2-2.99
~12 mg for patients 3-8.99 years of age
~15 mg for patients >9 years of age
~CNS 1 or 2 patients get doses on day 8, 22 and 35 and CNS 3 patients should get doses on day 8, 15, 22, 29 and 35"
16188364|NCT01483677|Other|Nintendo Wii|Subjects played the game Boomblox for 30 continuous minutes on the Nintendo Wii.
16188365|NCT01483677|Other|Playstation 2|Subjects played the game Time Crisis2 on the Playstation2 for 30 continuous minutes.
16188366|NCT01483651|Drug|Glucagon|The first dose of glucagon will be delivered approximately one hour after infusion of IV insulin has started. The subsequent three doses will be delivered every two hours. The dosage will depend on the IV insulin infusion (50 units regular insulin in 499.5 mL 0.9% saline): Study 1) insulin 0.01 units/kg/hour and glucagon doses (ug): 10,25,45,70; Study 2) insulin 0.02 units/kg/hr and glucagon doses (ug): 25,45,70,100; Study 3) insulin 0.04 units/kg/hr and glucagon doses (ug): 45,70,100,135; Study 4) insulin 0.08 units/kg/hr and glucagon doses (ug): 70,100,135,175. Insulin levels and glucagon doses will be randomized. Glucagon will be reconstituted with 10 mL of sterile water and administered subcutaneously.
16188367|NCT01483651|Drug|Insulin|Insulin was administered at a low, medium or high infusion rate. The intervention sequence was randomly pre-determined for all participants.
16188368|NCT01483638|Drug|axitinib|5 mg BID taken orally with food continuously on Day 1 of the study. One cycle corresponds to 28 days.
16188369|NCT01483638|Drug|placebo|will be administered orally with the same schedule of axitinib
16188370|NCT01483625|Drug|tiotropium|18mcg
16188371|NCT01483625|Drug|Placebo|placebo
16188372|NCT01483612|Behavioral|Interdisciplinary lifestyle intervention|"Individual meetings with a dietitian and a kinesiologist at 0, 3, 6 weeks and then every 6 weeks for 18 months or until delivery. A reminder phone call/email will also take place once between each meeting.
~The program also includes 12 group sessions discussing subjects about nutrition, psychology and demonstration of physical activity."
16188373|NCT01483599|Drug|CNTO 1959 (5 mg)|Subcutaneous (SC) injections
16188374|NCT01483599|Drug|CNTO 1959 (15 mg)|SC injections
16188375|NCT01483599|Drug|CNTO 1959 (50 mg)|SC injections
16188376|NCT01483599|Drug|CNTO 1959 (100 mg)|SC injections
16188377|NCT01483599|Drug|CNTO 1959 (200 mg)|SC injections
16188378|NCT01483599|Drug|Adalimumab|SC injections
16188379|NCT01483599|Drug|Placebo|SC injections
16188380|NCT01483586|Drug|kanglaite gelcap|3 KLTc gelcap capsules four times a day throughout the study (12 months). Each gelcap contains .45g KLT per capsule
16188381|NCT01483586|Drug|Kanglaite gelcap|6 KLTc gelcaps taken four times a day throughout the study (12 months). Each gelcap contains .45g KLT
16188382|NCT01483573|Other|neural mobilization|stretch the nerve
16188383|NCT01483573|Other|straight leg raise|stretch the hamstring
16188384|NCT01483560|Drug|Metformin|3 years treatment duration
16188385|NCT01483560|Drug|Placebo|3 years duration
16188386|NCT01483547|Device|Bispectral Index (BIS Vista, Covidien)|BIS values at LOC, PI, ROC.
16188387|NCT01483534|Device|TLD Therapy (IPS SystemTM)|Targeted Lung Denervation Therapy will be achieved bronchoscopically. As this is a single-arm, non-randomized study, it is anticipated that all patients who provide written informed consent and meet the protocol entry criteria will undergo treatment.
16188388|NCT01483521|Other|Clinical home visitation|Clinical Home visitation consisted of once a month visits to families on the experimental group. During those visits home visitors facilitated developmentally appropriate play guidance and co-construction tasks for the dyad.
16188389|NCT01483508|Other|Flavanol- and procyanidins-containing drink|Single oral intake of a cocoa-based dairy drink containing flavanols [monomer] and procyanidins [dimers to decamers]
16188390|NCT01483508|Other|Procyanidins-containing drink|Single oral intake of a ocoa-based dairy drink containing procyanidins [dimers to decamers]
16188391|NCT01483508|Other|Flavanol-containing drink|Single oral intake of a cocoa-based dairy drink containing flavanols [monomers]
16188392|NCT01483495|Device|Diffuse optical spectroscopy|Diffuse Optical Spectroscopy Imaging Cerebrovascular Reactivity
16188393|NCT01483482|Procedure|Conservative Treatment|Simple Sling
16188394|NCT01483482|Procedure|Surgical treatment|Superior Locking plate
16188395|NCT01483469|Drug|RO4917523|orally daily, 14 days
16188396|NCT01483469|Drug|RO5011232|[11C]-RO5011232 intravenously
16188397|NCT01483456|Other|"The multidisciplinary prevention program called IPR (in French Identifier, Prévenir, Relever)"|"The intervention is a multidisciplinary program of fall prevention including 3 complementary interventions which focus on several stages of elderly inpatient management:
~Identification of patient's fall risk,
~Multifactorial fall prevention program (integrated actions targeted on risk factors, exercise programs and review of the hospital environment),
~Get up workshop and morbidity and mortality conferences related to fall cases"
16188398|NCT01483443|Procedure|Oophrectomy|Both oophrectomy
16188399|NCT01483430|Drug|Ginseol Kg1 (low dose)|1 capsule/day (100mg of Ginseol Kg1), Duration: 8 weeks
16188400|NCT01483430|Drug|Ginseol Kg1(high dose)|1 capsule/day (300mg of Ginseol Kg1), Duration: 8 weeks
16188401|NCT01483430|Drug|Placebo|1 capsule/day (starch), Duration: 8 weeks
16188402|NCT01483417|Procedure|Single incision Laparoscopic hysterectomy|SILS port
16188403|NCT01483417|Procedure|Conventional laparoscopic hysterectomy|3-4 conventional ports
16188404|NCT01483404|Procedure|Measurement with O2c|Intra-surgery measurement of the microcirculation with the O2c device
16188405|NCT01483391|Behavioral|Enhanced Care|The 3 family sessions involve the youth and all family members. These sessions will help the child and family members with mood charting and developing a mood management plan. Families will rehearse mood regulation strategies for current family, social or academic problems. Clinicians then meet with the child individually every month for the next 3 mos. to provide support, assist with problem-solving, and troubleshoot use of the mood management plan.
16188474|NCT01482858|Dietary Supplement|Gastrolith|Gelatin capsules, each containing 500 mg of GASP (comprised of 125 ±5 mg elemental calcium) for oral use.
16188475|NCT01482858|Other|Placebo|Gelatin capsules, each containing 500 mg [comprised of 312.5 mg calcium carbonate (125 ±5 mg elemental calcium) and 187.5 mg of sucrose] for oral use as placebo
16188406|NCT01483391|Behavioral|Family-Focused Treatment|12 therapy sessions involving the at-risk child or adolescent, parents, and available siblings. Therapy will include psychoeducation about mood disorders, communication enhancement training, and problem-solving skills training. The goal of this intervention is to improve the child's ability to regulate moods and to reduce tension and conflict in the family.
16188407|NCT01483378|Other|Choosing to receive the vaccine|
16188408|NCT01483365|Drug|Vaginal tablet Endometrin twice a day|Endometrin 100 mg twice a day
16188409|NCT01483352|Device|Accu-Chek DiaPort|
16188410|NCT01483339|Behavioral|Metacognitive Therapy|Metacognitive Therapy for OCD according to Wells (1997)
16188411|NCT01483339|Behavioral|Exposure and Response Prevention|Exposure and Response Prevention for OCD according to Kozak & Foa (1997)
16188412|NCT01483300|Drug|lobaplatin|Gemcitabine 1000 mg/m2 d1, 8; Lobaplatin 30mg/m2 d1 q 3 weeks
16188413|NCT01483300|Drug|cisplatin|Gemcitabine 1000 mg/m2 d1, 8; Cisplatin 25 mg/m2 d1-3 q 3 weeks
16188414|NCT01483287|Dietary Supplement|Alpha-Galactosidase|"The study is conducted during a total of two days at two different occasions. Visit 1: The patients will be served breakfast and lunch at the gastro unit and dinner will be enclosed when the patient leave for home. At each meal (breakfast, lunch, and dinner) the participants will ingest three capsules with a total content of 1200 GaIU alpha-galactosidase-randomized to be either the enzyme (α-Galactosidase) or a non-active substance (placebo). Visit 2: The procedure from visit 1 will recur after at least two weeks has passed - except that the content of the capsules will be opposite from the first visit.
~No other food or beverage are ingested from 1800 hours the evening before the intervention day until breakfast the day after intervention (no exact time)."
16188415|NCT01483274|Biological|Vaccine|Decitabine followed by donor lymphocyte infusing and Dendritic cells pulsed with MAGE-A1, MAGE-A3, and NEY-ESO-1 vaccine
16188416|NCT01483261|Behavioral|Trauma-Focused Cognitive Behavioral Therapy|15 sessions of manualised, culturally modified trauma-focused cognitive behavior therapy
16188417|NCT01483248|Biological|conventional therapy plus MenSC transplantation|"patients will receive conventional treatment,such as antiviral drugs, lowering aminotransferase and jaundice medicine.
~MenSCs transplantation: taken i.v., twice per week, at a dose of 1*10E6 MSC/kg body for 2 weeks."
16188418|NCT01483248|Drug|Conventional therapy plus placebo treatment|25 of the enrolled patients were assigned to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.
16188419|NCT01483235|Behavioral|Reduced cardiac rehabilitation group intervention (rCRP).|The rCRP is a comprehensive intervention that will keep the same nature of therapies as the standard cardiac rehabilitation group (sCRP). The difference with the sCRP resides in the number of hospital based exercise sessions; instead of 32 sessions there will be 10 sessions spread throughout the 4 months of intervention (hence, not a shorter program). The rCRP intervention works within the sCRP. Hence, those randomized to the rCRP will be supervised in the same facility and by the same clinical staff as those in the sCRP. Patients from rCRP will receive individual exercise guidelines, an educational package with questions of the week and a diary to record their exercise sessions (logbook), that will serve as a self-monitoring system.
16188420|NCT01483235|Behavioral|Standard cardiac rehabilitation intervention|The standard cardiac rehabilitation is a multidisciplinary four-month intervention to modify ischemic heart disease risk factors and lifestyle behaviours. These programs aim to reduce morbidity and mortality by improving adherence to regular physical activity, a healthy diet and smoking cessation, as well as risk factor modification. Patients receive an initial intake evaluation by a cardiologist, nurse,exercise specialist and dietitian before starting the program. The program consists of 32, twice weekly in-hospital exercise sessions, educational sessions, nutritional counselling, medical care, psychological screening and smoking cessation if needed.
16188421|NCT01483222|Device|QUIKDRAW Pro, Aspen Medical Products|Wearing an inelastic lumbar support (QUIKDRAW Pro, Aspen Medical Products) for 6 months
16188422|NCT01483222|Device|MUELLER 4581, Mueller Sports Medicine|Wearing an elastic lumbar support (MUELLER 4581, Mueller Sports Medicine) for 6 months
16188423|NCT01483209|Drug|Injection of botulinum toxin A|One-time injection of 100 units of botulinum toxin into hand to perform full chemical digital sympathectomy
16188424|NCT01483196|Procedure|ultrasound imaging|Undergo TCD
16188425|NCT01483196|Other|questionnaire administration|Complete neurocognitive questionnaires
16188426|NCT01483196|Procedure|assessment of therapy complications|Undergo TCD
16188427|NCT01483196|Procedure|quality-of-life assessment|Ancillary studies
16188428|NCT01483196|Procedure|magnetic resonance imaging|Undergo MRI
16188429|NCT01483183|Drug|OPC-108459|"Part 1: single dose OPC-108459, 10-minute constant rate IV infusion to achieve specified Cmax target
~Part 2: single dose OPC-108459, 10-minute constant rate IV infusion to achieve Cmax target concentration from Part 1; if failure to convert to sinus rhythm, second dose OPC-108459 administered, 10-minute constant rate IV infusion to achieve target concentration from Part 1"
16188430|NCT01483183|Drug|Placebo|Placebo dose, 10-minute constant rate IV infusion
16188431|NCT01483170|Drug|Tablets Fexinidazole|Administration of 3 or 4 tablets of 600mg per day during 4 days (loading dose) then administration of 2 tablets of 600mg for 6 days Dosing in fed condition.
16188432|NCT01483170|Drug|Placebo|Placebo fexinidazole
16188433|NCT01483157|Other|vascular occlusion with exercise trainig|twelve weeks of resistance training with vascular occlusion twice a week
16188434|NCT01483157|Other|high intensity resistance training|twelve weeks of resistance training twice a week
16188435|NCT01483144|Drug|Eflornithine|Eflornithine [250 mg tablet, three tablets (750 mg) orally once a day]
16188436|NCT01483144|Drug|Eflornithine Placebo|Eflornithine placebo [three tablets orally once a day]
16188437|NCT01483144|Drug|Sulindac 150 MG|Sulindac [one tablet orally once a day]
16188438|NCT01483144|Drug|Sulindac placebo|Sulindac placebo [one tablet orally once a day]
16188439|NCT01483131|Other|Exercise training|12 weeks of resistance training twice a week.
16188440|NCT01483131|Other|Resistance training with vascular occlusion|12 weeks of resistance training with vascular occlusion twice a week
16188441|NCT01483118|Drug|Cinnamon Extract|Purified aqueous abstract of cinnamon in 125mg capsules, which would be taken orally before each meal, for a total of 1,500mg/day for 6 months.
16188442|NCT01483118|Dietary Supplement|Placebo|Placebo capsules containing ground cereal.
16188443|NCT01483105|Behavioral|DVD Self-Hypnosis Training Program|The DVD training program contains instructional materials developed by an experienced psychiatrist and psychologist at the Department of Psychiatry at Stanford University School of Medicine. Parents will be instructed to review these materials, watch the DVD, and practice the self-hypnosis exercises every day for a week with their child prior to the upcoming procedure. Parents are encouraged to practice self-hypnosis during their child's VCUG procedure.
16188444|NCT01483092|Dietary Supplement|inulin|20g/day for 4 weeks
16188445|NCT01483092|Dietary Supplement|maltodextrin|20g/day for 4 weeks
16188446|NCT01483066|Device|ShapeMatch Technology|ShapeMatch Technology places a plastic cutting guide on the end of the femur and tibia, so that cuts that do not automatically default to the mechanical axis, but rather attempt to recreate the patient's anatomic alignment.
16188447|NCT01483053|Drug|Agomelatine|Participants who are randomly assigned to the agomelatine group will be treated with agomelatine oral tablets for twelve weeks. Participants will begin their agomelatine treatment at 25mg/day dosage, increasing to 50mg/day as clinically indicated.
16188448|NCT01483053|Drug|Escitalopram|Participants who are randomly assigned to the escitalopram group will be treated with escitalopram oral tablets for twelve weeks. Participants will begin their escitalopram treatment at 10mg/day dosage, increasing to 20mg/day as clinically indicated.
16188449|NCT01483040|Device|colonoscopy system (PeerScope B System™)|Cancer of the colon and rectum is second only to lung cancer as the leading cause of cancer-related deaths in the United States.Each year, about 1.23 million new cases of bowel cancer are diagnosed worldwide, 333,000 in Europe alone. Colorectal cancer almost always starts in a benign growth called a polyp. Polyps originate in the inner lining of the colon, where they may be visible in a screening test known as colonoscopy. Recent research has shown that appropriate screening and treatment can alleviate much of the suffering associated with colorectal cancer and reduce the number of deaths caused by this malignancy
16188450|NCT01483027|Device|TheraSphere|yttrium 90 microspheres
16188451|NCT01483014|Drug|imatinib mesylate|
16188452|NCT01483001|Drug|Cancer Stem Cells Sensitivity Assay|To test in vitro sensitivity of cancer stem cells to several antineoplastic drugs in order to personalize treatment
16188453|NCT01482975|Other|Tailored computer based intervention|Best practices for TTM tailored communication with two types of feedback: normative - compared to peer and ipsative - self compared to previous assessment.
16188454|NCT01482975|Other|Tailored computer intervention|Best practices for TTM tailored communication with two types of feedback: normative - compared to peer and ipsative - self compared to previous assessment
16188455|NCT01482962|Drug|Alisertib|Alisertib enteric coated tablets
16188456|NCT01482962|Drug|Pralatrexate|Pralatrexate IV infusion
16188457|NCT01482962|Drug|Gemcitabine|Gemcitabine IV infusion
16188458|NCT01482962|Drug|Romidepsin|Romidepsin IV infusion
16188459|NCT01482949|Drug|AGS-003|Autologous Dendritic Cell Immunotherapy
16188460|NCT01482936|Drug|Oxycodone (OxyNorm®) Injection|The subjects will be randomized to receive a single dose of OxyNorm® 2.5, 5, and 10mg.The plasma concentration will be analyzed to determine the following pharmacokinetic parameters:AUC0-t:ug•hr/L-Area under the plasma concentration-time curve frame: predose,0,2min,5min,10min,15min,30min,45min,1hr,1.5hr,2hr,3hr,4hr,6hr,8hr,12hr, 24hr post-dose.AUC0-inf:ug•hr/L-Area under the plasma concentration-time curve extrapolated to infinity. Cmax: ug/L-Maximum observed plasma concentration of oxycodone and noroxycodone.Tmax: hrs-time at which Cmax is first observed. t½: Apparent half life of oxycodone elimination.
16188461|NCT01482923|Behavioral|Treatment as usual|Participants in the Treatment as Usual study arm will be provided with the following: 1) brief smoking cessation counseling as recommended in the Public Health Service treatment guidelines; 2) direct referral to the NY/NJ State Quitline; 3) a brochure that describes the Quitline services and provides contact information via telephone or internet; 4) a NY State brochure on HIV and smoking that identifies the specific risks of smoking for PLWHA; and 5) referral assistance to participants who present with untreated co-morbid conditions.
16188462|NCT01482923|Behavioral|AIR (Aspirations, Inspiration, Respiration)|Participants in the Aspirations, Inspiration, and Respiration study arm will receive all of the components of Treatment as Usual along with these additional components: 1) a lung age test to determine the ability and functioning of their lungs; 2) a personal lung health report with their lung age, the CO level of their breath, and a summary of their respiratory symptom assessment; 3) a review of this personal lung health report with a study counselor, 4) motivational interviewing techniques guided by Self-Determination Theory concepts to explicitly elicit at least one life aspiration of the patient and encourage discussion of such aspirations using an autonomy-supportive approach.
16188463|NCT01482910|Biological|Aflibercept (Eylea, VEGF Trap-Eye, BAY86-5321)|Participants in the VEGF Trap-Eye group received intravitreal injections every 8 weeks following a loading phase with injections given every 4 weeks for an overall treatment period of 48 weeks. Additionally, sham PDT treatments was administered as needed.
16188464|NCT01482910|Drug|Visudyne|Participants in the PDT group (Visudyne group) received Visudyne as needed. Additionally, sham IVT injections was administered until week 28. Thereafter, subjects in the PDT group received active (= no sham) VEGF Trap-Eye treatment until week 48.
16188465|NCT01482897|Drug|Prednisolone acetate|anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with corticoid (125mg in.5 ml)
16188466|NCT01482897|Drug|sham procedure|feigning of peridural infiltration : anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with placement of empty syringe in peridural.
16188467|NCT01482897|Drug|comparator : physiological solution|anesthetic bloc (10 ml of xylocaïne 1%) immediately followed with physiological solution (20 ml)
16188468|NCT01482884|Drug|tralokinumab|2 sc injections of every 2 weeks for 12 weeks.
16188469|NCT01482884|Drug|placebo|2 sc injections of every 2 weeks for 12 weeks.
16188470|NCT01482871|Drug|ALG-1001|1.5 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops
16188471|NCT01482871|Drug|ALG-1001|2.5 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops
16188472|NCT01482871|Drug|ALG-1001|5.0 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops
16188473|NCT01482871|Drug|ALG-1001|7.5 mg per 100ul injected in the eye on day 0, day 30 and day 60 and followed for 180 days until unacceptable toxicity develops
16188476|NCT01482845|Drug|ABT-126|Dose 1 is given to 8 subjects in Group 1. Dose 2 is given to 8 subjects in Group 2. All doses will be administered once daily in the morning for 10 days.
16188477|NCT01482845|Drug|Placebo|Placebo is given to 2 subjects each in Group 1 and Group 2. All doses will be administered once daily in the morning for 10 days.
16188478|NCT01482832|Behavioral|Interpersonal therapy-based treatment|Interpersonal therapy-based treatment Participants assigned to receive interpersonal therapy-based treatment will focus on the psychological aspects of pregnancy and factors that may play a role in the development of postpartum depression in teenage mothers, such as poor social support, role transitions, and life stressors. (5 weekly sessions with a booster session postpartum)
16188479|NCT01482819|Device|galyfilcon A|contact lenses worn bilaterally for 8-12 hours
16188480|NCT01482819|Device|galyfilcon A plus|contact lenses worn bilaterally for 8-12 hours
16188481|NCT01482819|Device|lotrafilcon A|contact lenses worn bilaterally for 8-12 hours
16188482|NCT01482819|Device|polymacon|contact lenses worn bilaterally for 8-12 hours
16188483|NCT01482819|Other|spectacles|habitual spectacles owned by subject, non-specific manufacturer
16188484|NCT01482806|Behavioral|CCBT+ISG/Collaborative Care|"Guided patient access to the Beating the Blues CCBT program plus access to a moderated ISG where patients will be able to communicate confidentially to receive and provide advice and peer-support from other study participants
~These interventions will be delivered as part of a collaborative care intervention provided in concert with their usual source of primary care.
~Patients will also have the option of pharmacotherapy for their mood and/or anxiety disorder and referral to a community mental health specialist per their preference."
16188485|NCT01482806|Behavioral|CCBT/Collaborative Care|"Guided patient access to the Beating the Blues CCBT program.
~This interventions will be provided as part of a collaborative care intervention provided in concert with their usual source of primary care.
~Patients will also have the option of pharmacotherapy for their mood and/or anxiety disorder and referral to a community mental health specialist per their preference."
16188486|NCT01482793|Procedure|Vertebroplasty|AVAmax radiopaque bone cement is injected into the vertebral body using a 13 G or 11 G vertebroplasty needle.
16188487|NCT01482780|Device|PICSO|PICSO (pressure controlled intermittent coronary sinus occlusion) will be used in the pre ECC period. The procedure of PICSO will be performed in analogy to retrograde cardioplegia.
16188488|NCT01482767|Drug|Pegylated-Interferon Alfa 2b (PEG-IFN)|1.5 mcg/kg subcutaneously (SC) once a week (based on participant's weight at entry) for up to 48 weeks depending on cirrhosis status and, in Group A, Week 8 HCV viral response.
16188489|NCT01482767|Drug|Ribavirin (RBV)|800-1400 mg orally per day with food (based on participant's weight at entry) for up to 48 weeks depending on cirrhosis status and, in Group A, Week 8 HCV viral response.
16188490|NCT01482767|Drug|Boceprevir (BOC)|800 mg orally every 8 hours with food from Week 5 to up to Week 48 depending on cirrhosis status and, in Group A, Week 8 HCV viral response
16188491|NCT01482754|Drug|Rituximab (Mabthera®, Roche Pty Ltd, Basel, Switzerland)|Recommended and approved dosage of Rituximab is 375mg/m2. The recommended guideline for Rituximab infusion for first cycle is commencing at an infusion rate of 50mg/hr for the first 30 minutes. If tolerated well, the subsequent increments will step up to 50mg/hr every 30 minutes to a maximum dose of 400mg/hr. For second and subsequent infusions, the infusion rate commences at 100mg/hr with 30 minute increments of 100mg/hr to a maximum dose of 400mg/hr. The first and subsequent infusion generally completes between 5-6 and 3-4 hours respectively.
16188492|NCT01482741|Behavioral|Focus Group Sessions|Participants will complete a pre-focus group demographic questionnaire. Focus group participants will be asked to report the following: current age; gender; race/ethnicity; income; highest education attained; occupation; and cancer stage if participant has a cancer history. Participants who are parents of pediatric patients will also report their child's current age, gender, and cancer stage. Ten questions will be developed by the investigators and posed to each group by the moderator to solicit the desired information. The objective for the focus groups will be to systematically explore three domains: 1) what participants know about radiation as it relates to medical imaging; 2) how what they know or believe about radiation shapes their attitudes about it; 3) and participant perceptions regarding the availability and adequacy of their sources, including risk-benefit communication with health care providers
16188493|NCT01482741|Behavioral|Focus Group Sessions|Participants will complete a pre-focus group demographic questionnaire. Focus group participants will be asked to report the following: current age; gender; race/ethnicity; income; highest education attained; occupation; and cancer stage if participant has a cancer history. Participants who are parents of pediatric patients will also report their child's current age, gender, and cancer stage. Ten questions will be developed by the investigators and posed to each group by the moderator to solicit the desired information. The objective for the focus groups will be to systematically explore three domains: 1) what participants know about radiation as it relates to medical imaging; 2) how what they know or believe about radiation shapes their attitudes about it; 3) and participant perceptions regarding the availability and adequacy of their sources, including risk-benefit communication with health care providers
16188494|NCT01482741|Behavioral|Focus Group Sessions|Participants will complete a pre-focus group demographic questionnaire. Focus group participants will be asked to report the following: current age; gender; race/ethnicity; income; highest education attained; occupation; and cancer stage if participant has a cancer history. Participants who are parents of pediatric patients will also report their child's current age, gender, and cancer stage. Ten questions will be developed by the investigators and posed to each group by the moderator to solicit the desired information. The objective for the focus groups will be to systematically explore three domains: 1) what participants know about radiation as it relates to medical imaging; 2) how what they know or believe about radiation shapes their attitudes about it; 3) and participant perceptions regarding the availability and adequacy of their sources, including risk-benefit communication with health care providers
16188519|NCT01482598|Device|Remote Care Follow up|Patient device is checked daily through remote transmitter (Merlin@Home) and every 6 month a complete transmission with all device data is performed
16188520|NCT01482585|Other|CT, PET, copy number alteration|Duel-energy CT, PET, copy number alteration
16188521|NCT01482572|Procedure|biopsy|percutaneous lung biopsy and aspiration
16188522|NCT01482559|Drug|Dopamine hydrochloride|Active drug substance 1.5 mg in 1 mL IV Infusion Minimum dose = 5mcg/kg/min Maximum dose = 20mcg/kg/min
16192927|NCT01450007|Drug|Ropivacaine|25 ml ropivacaine 0.5%
16188495|NCT01482741|Behavioral|Focus Group Sessions|Participants will complete a pre-focus group demographic questionnaire. Focus group participants will be asked to report the following: current age; gender; race/ethnicity; income; highest education attained; occupation; and cancer stage if participant has a cancer history. Participants who are parents of pediatric patients will also report their child's current age, gender, and cancer stage. Ten questions will be developed by the investigators and posed to each group by the moderator to solicit the desired information. The objective for the focus groups will be to systematically explore three domains: 1) what participants know about radiation as it relates to medical imaging; 2) how what they know or believe about radiation shapes their attitudes about it; 3) and participant perceptions regarding the availability and adequacy of their sources, including risk-benefit communication with health care providers
16188496|NCT01482741|Behavioral|Focus Group Sessions|Participants will complete a pre-focus group demographic questionnaire. Focus group participants will be asked to report the following: current age; gender; race/ethnicity; income; highest education attained; occupation; and cancer stage if participant has a cancer history. Participants who are parents of pediatric patients will also report their child's current age, gender, and cancer stage. Ten questions will be developed by the investigators and posed to each group by the moderator to solicit the desired information. The objective for the focus groups will be to systematically explore three domains: 1) what participants know about radiation as it relates to medical imaging; 2) how what they know or believe about radiation shapes their attitudes about it; 3) and participant perceptions regarding the availability and adequacy of their sources, including risk-benefit communication with health care providers
16188497|NCT01482741|Behavioral|Focus Group Sessions|Participants will complete a pre-focus group demographic questionnaire. Focus group participants will be asked to report the following: current age; gender; race/ethnicity; income; highest education attained; occupation; and cancer stage if participant has a cancer history. Participants who are parents of pediatric patients will also report their child's current age, gender, and cancer stage. Ten questions will be developed by the investigators and posed to each group by the moderator to solicit the desired information. The objective for the focus groups will be to systematically explore three domains: 1) what participants know about radiation as it relates to medical imaging; 2) how what they know or believe about radiation shapes their attitudes about it; 3) and participant perceptions regarding the availability and adequacy of their sources, including risk-benefit communication with health care providers
16188498|NCT01482728|Drug|Dasatinib|100 mg dasatinib, the day before surgery and the day of surgery
16188499|NCT01482728|Drug|Dasatinib|200 mg dasatinib the day before surgery and the day of surgery
16188500|NCT01482715|Drug|Rucaparib|Oral tablets administered daily with 8 oz (240 mL) of water on an empty stomach or with food; 21-day cycles of treatment. In Part 1, the initial dose level is 40 mg/day (once a day); doses and dosing frequency(e.g. twice a day or three times a day) will be adjusted until Maximum Tolerated Dose (MTD) and the Recommended Phase 2 Dose (RP2D) are established. Patients enrolled in Part 2 and Part 3 will receive the RP2D for continuous 21-day treatment cycles until disease progression.
16188501|NCT01482702|Behavioral|weight loss intervention|Behavioral weight loss intervention
16188502|NCT01482702|Behavioral|Weight Loss|Behavioral weight loss intervention
16188503|NCT01482702|Behavioral|Weight Loss|Behavioral weight loss intervention
16188504|NCT01482689|Dietary Supplement|Fish oil capsule (specially manufactured for the study)|One capsule per day for 4 weeks (28 days). The fish oil group receives a daily supplement of one fish oil capsule, specially manufactured for the present study by Peter Möller (now Möller's, Nydalen, Norway). The fish oil capsules are aimed to contain a dose of cholecalciferol identical to the dose already found in the multivitamin tablets by analysis in an independent laboratory (AS Vitas, Oslo, Norway), and similar doses of vitamin A. In addition, the fish oil capsule contains vitamin E and n-3 fatty acids.
16188505|NCT01482689|Dietary Supplement|Multivitamin tablet of type: Vitaplex ABCD|One tablet per day for 4 weeks (28 days). The multivitamin group receives a daily supplement of one multivitamin tablet of type Vitaplex ABCD (Cederroth AS, Revetal, Norway), a common vitamin supplement sold in grocery stores in Norway. In addition to 10 micrograms (400 IU) of cholecalciferol,the multivitamin tablet contains vitamin A and the water-soluble vitamins: B1, B2, B6, Niacin, pantothenic acid, and vitamin C.
16188506|NCT01482663|Behavioral|Healthy Skin Clinic|"The intervention is founded upon three concurrent elements. Firstly, a SKIN-profile generated by data from a baseline questionnaire (S=Susceptibility, K=Competencies, I=Individual characteristics, N=Necessary precautions).
~Secondly, a patient self-management book which includes a patient's log and is offered in both an online and a physical form. Also support to self-management is offered through possible asynchronous communication and networking.
~Finally, a counselling consultation with a nurse, trained within dermatology."
16188507|NCT01482650|Device|supraglottic airway placement and use|The investigators will place the device (Baska mask or LMA) according to a pre-defined protocol and monitor its performance intra and postoperatively.
16188508|NCT01482637|Other|CAS|All clients will be asked to complete the CAS instrument.
16188509|NCT01482624|Device|Hyaluronan (0.5%, 5 mg/10 ml)|Standard arthroscopic meniscal surgery and add-on treatment with VISCOSEAL® SYRINGE. Single injection of Hyaluronan directly after arthroscopic procedure.
16188510|NCT01482624|Procedure|Standard arthroscopic meniscal surgery|Standard arthroscopic meniscal surgery without add-on treatment.
16188511|NCT01482611|Drug|JNJ-47910382|Type = exact number, unit = mg, number = 10, 75, 300, form = suspension, route = oral use.
16188512|NCT01482611|Drug|JNJ-47910382|Type = exact number, unit = mg, number = 30, 150, 600, form = suspension, route = oral use.
16188513|NCT01482611|Drug|JNJ-47910382|Type = exact number, unit = mg, number = To be determined, form = suspension, route = oral use.
16188514|NCT01482611|Drug|JNJ-47910382|Type = exact number, unit = mg, number = To be determined, form = suspension, route = oral use.
16188515|NCT01482611|Drug|Placebo|Type = exact number, unit = mg, number = equivalent of 10, 75, 300, form = suspension, route = oral use.
16188516|NCT01482611|Drug|Placebo|Type = exact number, unit = mg, number = equivalent of 30, 150, 600, form = suspension, route = oral use
16188517|NCT01482611|Drug|Placebo|Type = exact number, unit = mg, number = equivalent dose to be determined, form = suspension, route = oral use.
16188518|NCT01482611|Drug|Placebo|Type = exact number, unit = mg, number = equivalent dose to be determined, form = suspension, route = oral use
16188523|NCT01482559|Drug|Dextrose 5%|IV Infusion Minimum dose = 5mcg/kg/min Maximum dose = 20mcg/kg/min
16188524|NCT01482468|Drug|continuous infusion of palonosetron added to prophylactic single injection of palonosetron|continuous infusion of palonosetron 0.00075 mg/hour after single injection of palonosetron 0.075mg
16188525|NCT01482468|Drug|continuous infusion of normal saline added to prophylactic single injection of palonosetron|continuous infusion of normal saline after single injection of palonosetron 0.075mg
16188526|NCT01482455|Other|Elevation of FFA during OGTT|"0-240 min: Intralipid® 20%, Pharmacia AB, Stockholm, Sweden, 90 ml/hr; Heparin Immuno®, Immuno AG, Vienna, Austria, bolus: 200IU, continuous infusion: 0.2 IU.kg-1.min-1"
16188527|NCT01482455|Other|Elevation of FFA during Clamp|"0-240 min: Intralipid® 20%, Pharmacia AB, Stockholm, Sweden, 90 ml/hr; Heparin Immuno®, Immuno AG, Vienna, Austria, bolus: 200IU, continuous infusion: 0.2 IU.kg-1.min-1."
16188528|NCT01482442|Drug|sorafenib|Patients will receive continuous oral treatment with 800 mg of sorafenib daily (Nexavar, Bayer HealthCare Pharmaceuticals-Onyx Pharmaceuticals). Treatment interruptions and dose reductions (to 400 mg once daily) will be permitted for drug-related adverse effects. At the discretion of the investigator, the dose may be re-escalated to after the resolution of the adverse event.
16188529|NCT01482442|Drug|SIR-Sphere|The first step will check patient eligibility and prepare conditioning by performing selective mesenteric and hepatic angiography (to document the arterial tumor supply and to occlude extrahepatic vessels) and 99mTc-macroaggregated albumin scintigraphy. The second step is RADIOEMBOLIZATION therapy. One to two weeks after patient eligibility and conditioning, treatment is performed with SIR-Sphere (SIRTEX Medical Ltd.,Lane Cove,Australia).
16188530|NCT01482429|Other|Multidisciplinary weaning-ventilator protocol|We implemented a multidisciplinary protocol for weaning from mechanical ventilation.This consist of a daily screening for readiness, performing a spontaneous breathing test, evaluation of signs of intolerance and decision on extubation.
16188531|NCT01482416|Drug|Estrogens, Conjugated (USP)|Experimental group will use 0.625mg/day during 30 days
16188532|NCT01482416|Drug|Placebo|Placebo group will use placebo once/day during 30 days
16188533|NCT01482403|Drug|Copegus|total daily dose of 1000 mg or 1200 mg for 24 weeks
16188534|NCT01482403|Drug|Copegus|total daily dose of 1000 mg or 1200 mg for 48 weeks
16188535|NCT01482403|Drug|Pegasys|180 microgram subcutaneous once a week for 24 weeks
16188536|NCT01482403|Drug|Pegasys|180 microgram subcutaneous once a week for 48 weeks
16188537|NCT01482403|Drug|boceprevir|800 mg three times a day for 24 weeks
16188538|NCT01482403|Drug|boceprevir|800 mg three times a day for 48 weeks
16188539|NCT01482403|Drug|mericitabine|1000 mg twice daily for 24 weeks
16188540|NCT01482403|Drug|mericitabine placebo|mericitabine placebo
16188541|NCT01482403|Drug|boceprevir placebo|boceprevir placebo
16188542|NCT01482403|Drug|boceprevir|800 mg three times a day for 44 weeks
16188543|NCT01482390|Drug|Ribavirin|Participants will receive a total daily dose of 1000 milligrams (mg) (for participants weighing less than [<] 75 kg) or 1200 mg (for participants weighing greater than or equal to [>=] 75 kg) orally for 24 or 48 weeks.
16188544|NCT01482390|Drug|Mericitabine|Participants will receive mericitabine 1000 mg orally twice daily.
16188545|NCT01482390|Drug|Peginterferon Alfa-2a|Participants will receive 180 micrograms (mcg) subcutaneous injection once weekly.
16188546|NCT01482390|Drug|Placebo|Participants will receive placebo matching to mericitabine orally twice daily.
16188547|NCT01482390|Drug|Telaprevir|Participants will receive telaprevir 750 mg orally three times daily.
16188548|NCT01482377|Drug|RO5479599|RO5479599 will be administered Q2W or Q3W (other regimen could be explored based on observations during dose escalation part).
16188549|NCT01482377|Drug|Cetuximab|Cetuximab will be administered via intravenous (IV) infusion at a starting dose of 400 mg/m^2 for the first infusion, followed by doses of 250 mg/m^2 for subsequent infusions.
16188550|NCT01482377|Drug|Erlotinib|Erlotinib, at a dose of 150 mg will be administered.
16188551|NCT01482377|Drug|zirconium-89-labeled RO5479599|Single dose of radiolabeled drug will be administered.
16188552|NCT01482364|Device|Integrated hemodynamic management (IHM) - HOTMAN System|Therapeutic approach according to HOTMAN System measurement(ICG)results .
16188553|NCT01482364|Device|Non Integrated Hemodynamic Management (Non-IHM) - HOTMAN System|Therapeutic approach according to 2007 ESH Guidelines, regardeless HOTMAN results.
16188554|NCT01482351|Behavioral|CPAP adherence intervention|Critical factors were (1) OSA education, treatment expectations, and ways to minimize barriers and facilitate CPAP use; (2) promotion of a positive initial CPAP experience; (3) motivational interviewing to reinforce participants' health-related goals and CPAP self-efficacy; (4) anticipatory guidance and follow-up of common CPAP problems; and (5) social support by a study partner. Trained project staff provided the intervention by phone and face to face for a total of 12-14 hours over the 1 year project.
16188555|NCT01482351|Behavioral|Attention control intervention|This intervention, provided by phone and face to face by project staff, provided equal time and attention. Critical factors were (1) education about OSA and risks, (2) education about memory, and other health topics of interest to the participants; (3) motivational interviewing to reinforce participants' health-related goals; (4) building rapport, and (5) social support by a study partner.
16188556|NCT01482338|Drug|EE 20 microgram with desogestrel 150 mg|Comparison of 2 different low-dose oral contraceptive pill which one consists of 20 microgram ethinyl estradiol and 150 mg desogestrel and the other consists of 20 microgram ethinyl estradiol and 3 mg drospirenone. Both were taken orally by participants every day beginning Day1 to Day 3 of the first menstrual cycle until complete 24 days and continued with free-hormone pills for 4 days. The next cycle has to continue in the same way until complete 6 cycles.
16188557|NCT01482338|Drug|EE 20 microgram with drospirenone 3 mg|Comparison of 2 different low-dose oral contraceptive pill which one consists of 20 microgram ethinyl estradiol and 150 mg desogestrel and the other consists of 20 microgram ethinyl estradiol and 3 mg drospirenone. Both were taken orally by participants every day beginning Day1 to Day 3 of the first menstrual cycle until complete 24 days and continued with free-hormone pills for 4 days. The next cycle has to continue in the same way until complete 6 cycles.
16188558|NCT01482325|Device|Blood pressure monitoring with GE Healthcare DASH2500 Patient Monitor|10-20 Non-Invasive Blood Pressure readings on investigational software in the DASH2500 Patient Monitor
16188624|NCT01481766|Dietary Supplement|Placebo|0.4 ml/kg/day in 2 or 3 divided doses (at the discretion of prescribing study doctor) for four months plus dietary counseling
16188559|NCT01482312|Device|lotrafilcon A contact lenses|Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
16188560|NCT01482312|Device|comfilcon A contact lenses|Commercially marketed, silicone hydrogel, single-vision, soft contact lenses FDA-approved for daily and extended (overnight) wear for up to 30 nights of continuous wear.
16188561|NCT01482312|Other|Glasses|Glasses per habitual prescription
16188562|NCT01482299|Drug|RAD001|"RAD001 (everolimus) 10 mg daily, orally without interruption.
~1 cycle is equal to 4-week treatment. Treatment will be continued unless disease progression or intolerability."
16188563|NCT01482286|Drug|Metformin|Subjects randomized to the metformin treatment group will receive 1000 mg extended release metformin hydrochloride tablets (Bristol Myers Squibb) twice per day with food approximately 8 hours apart.
16188564|NCT01482286|Behavioral|Dietary Restriction|Subjects randomized to the dietary restriction group will reduce their energy intake by 25% of their weight maintenance energy intake determined at baseline. Total energy expenditure as measured by a 14-day doubly labeled water (DLW) study will be used to determine the baseline energy intake of each subject. There will be no gradual ramping of dietary restriction. The 25% energy reduction goal will apply from the first day of the intervention for a period of 24 weeks. Subjects will be asked to not modify their normal level of physical activity.
16188565|NCT01482286|Behavioral|Exercise Training|"For the aerobic training component, subjects are required to meet a weekly energy expenditure target of 10 kcal per kg of body weight per week (KKW).
~The resistance training program will be performed 2 days a week. The resistance program includes 9 exercises. The 9 primary exercises are seated chest press, seated row, shoulder press, lat pull down, double leg press, leg extension, leg curl, back extension and abdominal crunch."
16188566|NCT01482273|Procedure|CDT+US group|CDT using the EkoSonic Endovascular System with intravascular high-frequency, low-power ultrasound for 15 hours.
16188567|NCT01482273|Procedure|CDT-US group|CDT using the EkoSonic Endovascular System without intravascular high-frequency, low-power ultrasound for 15 hours.
16188568|NCT01482260|Procedure|Biopsy|Biopsy
16188569|NCT01482247|Dietary Supplement|L-Arginine|Dietary Supplement
16188570|NCT01482247|Dietary Supplement|Placebo Supplement|Dietary Supplement
16188571|NCT01482234|Behavioral|TXT Me|text messages, physical activity, self determination theory, extrinsic motivation, intrinsic motivation, pedometers, walking, prompts
16188572|NCT01482221|Drug|AZD6765 iv|50 mg (AZD6765 Solution for Infusion, 0.5 mg/mL) by iv infusion.
16188573|NCT01482221|Drug|AZD6765 iv|100 mg (AZD6765 Solution for Infusion, 1.0 mg/mL) by iv infusion.
16188574|NCT01482221|Drug|Placebo|0.9 sodium chloride [normal saline] solution for injection by iv infusion
16188575|NCT01482195|Biological|Subretinal administration of rAAV2-VMD2-hMERTKRecombinant Adeno-Associated Virus|The study is an open-label, dose-escalation, phase I clinical trial of subretinal administration of rAAV2-VMD2-hMERTK in patients with retinitis pigmentosa due to MERTK mutation.
16188576|NCT01482169|Drug|FFR Measurement with IV Adenoscan® then with Regadenoson|Testing will be completed during a Left Heart Catheterization (LHC). The first 48 eligible patients enrolled will receive an initial infusion of IV Adenoscan® through a peripheral vein at 140 mcg/kg/min. FFR measurements will be obtained utilizing a coronary pressure guide wire once peak hyperemia has been achieved. It takes about 84 seconds to reach peak hyperemia with Adenoscan®. Subsequently, these subjects will receive a dose of regadenoson at 0.4 mg through the same peripheral access site. FFR measurements will be obtained once peak hyperemia is achieved, which takes less than 30 seconds with regadenoson. Patients who react to either medication will be supported conservatively under close scrutiny.
16188577|NCT01482156|Drug|RAD001 + BEZ235|RAD001 is formulated as tablets of 2.5 mg and 5 mg strength, blistered in units of 10 tablets (for oral use) each. Blisters should be opened only at the time of dministration as the drug is both hygroscopic and light-sensitive. RAD001 should be administered immediately after a meal with a large glass of water. BEZ235 is supplied as 50-mg, 200-mg, 300-mg and 400-mg sachets (for oral use). BEZ235 is packaged in aluminum foil bags. Bags are packaged in a box. Patients will receive RAD001 in combination with BEZ235.
16188578|NCT01482143|Drug|AFQ056|
16188579|NCT01482130|Behavioral|Heavy, explosive strength training|All participants of the training group will pursue a 12 weeks of heavy, explosive strength training, 3 sessions a week for a total of 36 sessions. The training session will include one squat exercise only, which allows muscle contraction of the quadriceps from a 90° bend at the knees to straight legs.
16188580|NCT01482130|Behavioral|recommendations|"The control group will be encouraged to follow a training program according to recommended exercise guidelines:
~Weight bearing activities (walking, jogging or strength training)
~30 - 60 minutes, 3 - 5 times each week
~A total of 2 - 3 hours each week should be achieved"
16188581|NCT01482117|Drug|Clopidogrel|single oral administration of 300mg of clopidogrel
16188582|NCT01482117|Drug|Cilostazol|single oral administration of 100mg cilostazol
16188583|NCT01482117|Drug|Clopidogrel/Cilostazol|single oral administration of 300mg clopidogrel and 100mg cilostazol
16188584|NCT01482104|Drug|MAL-PDT re-treatment|a schedule of 1 single treatment of Metvix(R)-Photodynamic therapy with re-treatment of non-complete responders by 3 months
16188585|NCT01482104|Drug|usual MAL-PDT|schedule of 2 standard Metvix(R)- Photodynamic therapy treatment sessions 1 week apart.
16188586|NCT01482091|Drug|Fentanyl Citrate|A single dose of fentanyl citrate (2 mcg/kg; max 100mcg) administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device
16188587|NCT01482091|Drug|Normal Saline|A single dose of equivalent volume of 0.9% Normal Saline will be administered intranasally. Half of the volume will be administered in each nare. The medication will be administered using a mucosal atomization device.
16188588|NCT01482065|Device|CPAP (ResMed S9 autoset CPAP)|A ResMed S9 autoset CPAP device will be utilized throughout the study. Throughout the study intervention period, subjects (for AHI> 15) will be instructed to utilize their CPAP and adherence will be monitored using an automatic meter that is built into the CPAP device.
16188589|NCT01482052|Biological|meningococcal meningitis conjugate vaccine, quadrivalent|NmVac4-A/C/Y/W-135-DT™conjugate is a vaccine in liquid form composed of purified polysaccharides (PS) conjugated to diphtheria toxoid. Single intramuscular 0.5 mL dose contains 4 µg each Serogroup A, C, W-135, Y PS conjugated to approximately 16 µg total diphtheria toxoid.
16188590|NCT01482052|Biological|meningococcal meningitis conjugate vaccine, quadrivalent|Meningococcal (Groups A,C,Y and W-135-DT) Polysaccharide Conjugate Vaccine 0.5 mL dose, intramuscular. Single dose contains 4 µg each Serogroup A, C, W-135, Y PS conjugated to approximately 48 µg total diphtheria toxoid.
16188591|NCT01482039|Procedure|Sequential ultrasound|Abdominal ultrasound first; obtain 3 adequate measurements. If 3 adequate views not obtained or if measurement less than 3 cm, perform transvaginal ultrasound for measurement.
16188592|NCT01482039|Procedure|Transvaginal ultrasound|Obtain 3 transvaginal ultrasound cervical length measurements
16188593|NCT01482026|Other|ADHD Rating Scale-IV|ADHD Rating Scale-IV test
16188594|NCT01482026|Other|ADHD Rating Scale-IV|ADHD Rating Scale-IV test
16188595|NCT01482013|Drug|HPP854|Oral, once a day for 28 days.
16188596|NCT01482013|Drug|Placebo|Oral, once a day for 28 days.
16188597|NCT01482000|Other|Pulmonary daoyin therapy of China|The intervention group will perform a 3 months pulmonary daoyin of China therapy program which consists of training and patient education. They will be evaluated with some tests for the study.
16188598|NCT01482000|Other|usual care|The control group will get the usual care with some additional tests for the study.
16188599|NCT01481987|Procedure|Epiretinal Membrane Surgical treatment|epiretinal membrane peeling
16188600|NCT01481974|Drug|Treprostinil|"The Treatment Phase will begin at the initiation of Treprostinil after induction of anesthesia for the transplant surgery and continues throughout the surgery and for approximately a total of 120 hours.
~Treatment phase activities include:
~• Initiation of Treprostinil after the patient is hemodynamically stable following transplant surgery. (Treprostinil dosing will follow a standard 3 + 3 phase 1 design."
16188601|NCT01481961|Procedure|repetitive Transcranial Magnetic Stimulation (rTMS)|After locating the left DLPFC, treatment with active rTMS will be directed by 20-minute session during which pulse trains of 5 seconds of 10 Hz spaced 25 seconds (2 trains of pulses per minute or 40 pulse trains per session). Treatment will occur 2 sessions per day during 5 days per week. Subjects will be monitored during rTMS for any side effects or adverse events.
16188602|NCT01481948|Behavioral|Food, Fun, & Fitness Internet Program for Girls|This is an 8 episode intervention, delivered entirely over the internet. Each episode, girls will view an interactive story in which 6 8-10 year old African American characters attempt to solve a mystery about their town. The online program will include information about healthy nutrition (i.e., consuming more fruit, vegetables, water) and physical activity. There will be two groups; one group (the experimental group) will view the interactive story and participate in key behavior change procedures, such as personal goal setting, problem solving, and self monitoring activities. The second group (the active comparator group) will view the online stories but will not engage in key behavior change procedures.
16188603|NCT01481935|Other|Enhanced cleaning of surfaces in ICU rooms|Using a paper towel pre-soaked with a commercially-available quaternary ammonium cleaning solution (Virex WetTask wipes, Kimberly-Clark, Irving, Texas), the following surfaces will be wiped clean by a study investigator if present: bed rail top bar, bed electronic control surfaces, moveable tray table top and control surfaces desktop and sides, IV poles, infusion pump control surfaces, nurse call button, patient telephone/remote control, sink console top, light switches and plates, supply cart top and drawer handles, ventilator control surfaces and desk, vital signs monitor control surfaces. Cleaning will occur once on the day of enrollment and follow-up.
16188604|NCT01481935|Other|Sham enhanced cleaning of surfaces in ICU rooms|While holding a paper towel pre-soaked with a commercially-available quaternary ammonium cleaning solution (Virex WetTask wipes, Kimberly-Clark, Irving, Texas), a study investigator will mime the action of wiping the following surfaces in the room clean if present: bed rail top bar, bed electronic control surfaces, moveable tray table top and control surfaces desktop and sides, IV poles, infusion pump control surfaces, nurse call button, patient telephone/remote control, sink console top, light switches and plates, supply cart top and drawer handles, ventilator control surfaces and desk, vital signs monitor control surfaces. The sham cleaning will occur once on the day of enrollment and follow-up.
16188605|NCT01481922|Device|whitacre 24 gauge|Whitacre 24 gauge spinal needle 3 inches 1/2. Manufactured by Becton Dickinson
16188606|NCT01481922|Device|whitacre 22 gauge|Whitacre 22 gauge spinal needle 3 inches 1/2 manufactured by Becton Dickinson
16188607|NCT01481909|Drug|Rupatadin|20 mg, 28 days over 60 days
16188608|NCT01481896|Device|Metal-on-metal primary total hip arthroplasty (DePuy )|Replacement of a patient's native hip with an artificial implant featuring a metal-on-metal articulation
16188609|NCT01481883|Drug|Raloxifene Hydrochloride|120mg daily - 1 capsule daily for 12 week trial
16188610|NCT01481883|Drug|Placebo|1 capsule daily for 12 week trial
16188611|NCT01481870|Drug|Sorafenib-sunitinib|sorafenib 400mg b.i.d. followed by sunitinib treatment when progression is observed
16188612|NCT01481870|Drug|Sunitinib-sorafenib|sunitinib 50mg q.d. 4 weeks on two weeks off followed by sorafenib treatment when progression is observed
16188613|NCT01481857|Other|Segmental trunk exercise associated with proprioception|Proprioceptive exercise
16188614|NCT01481857|Other|Segmental trunk exercise|Segmental trunk exercise
16188615|NCT01481844|Drug|Lansoprazole , Tab Amoxycillin , Tab Clarithromycin ,Tab Tinidazole|use of Sequential therapy as second line treatment for eradication H pylori currently Sequential therapy is indicated as first line treatment for H pylori eradication
16188616|NCT01481844|Drug|Lansoprazole, Bismuth Subsalicylate, Metronidazole, Tetracycline|this combination is standard of care as H pylori second line treatment
16188617|NCT01481831|Drug|Palonosetron Hydrochloride|0.25 mg IV*1 dose on day 1, 30 minutes prior to the administration of the major chemotherapeutic agent.
16188618|NCT01481831|Drug|Palonosetron Hydrochloride|0.25mg IV*3 doses on days 1,3 and 5,30 minutes prior to the administration of the major chemotherapeutic agent.
16188619|NCT01481818|Drug|EGCG|Apply about 0.05ml/cm2 EGCG with different concentration topically for 3 times a day during radiotherapy
16188620|NCT01481779|Drug|Glargine|Administered by SC injection via a pen device.
16188621|NCT01481779|Drug|LY2605541|Administered by SC injection with a pen device.
16188622|NCT01481779|Drug|Insulin Lispro|Administered by SC injection with a pen device.
16188623|NCT01481766|Dietary Supplement|Ferrous Sulfate|6 mg elemental iron/kg/day (0.4 ml/kg/day) in 2 or 3 divided doses (at the discretion of prescribing study doctor) for four months plus dietary counseling
16188662|NCT01481493|Biological|BT061|subcutaneous administration of the monoclonal antibody BT061
16188625|NCT01481766|Behavioral|Dietary counseling|Dietary counseling will include written recommendations regarding maximum daily cow's milk intake, varied solid food intake including high iron containing foods, and avoidance of foods which reduce iron absorption.
16188626|NCT01481753|Procedure|pancreaticoduodenectomy without Braun enteroenterostomy|no Braun enteroenterostomy has been added to standard pancreaticoduodenectomy; pancreaticoduodenectomy without Braun enteroenterostomy
16188627|NCT01481753|Procedure|Braun enteroenterostomy|addition of Braun enteroenterostomy (side-to-side anastomosis between the afferent and efferent loops of the gastrojejunostomy) to standard PD reconstruction can decrease the rates of POPF and/or DGE, improving the perioperative outcome of patients undergoing PD.
16188628|NCT01481740|Drug|Phenylephrine bolus|10 ml of 100mcg/ml phenylephrine and placebo infusion
16188629|NCT01481740|Drug|phenylephrine infusion|60ml infusion of 100mcg/ml phenylephrine and placebo bolus
16188630|NCT01481727|Device|BiPAP Pro 2, Phillips Respironics|mechanical ventilation type bilevel at high intensity (>18mmHg) for at least six hours, nocturnal ventilation.
16188631|NCT01481727|Device|CPAP sham|CPAP sham maneuver (IPAP less or equal to 4cmH2O)
16188632|NCT01481714|Drug|Sodium picosulphate, magnesium oxid and citric acid|"A sachet mixed with 250 mL of water at 18:00 pm
~A sachet mixed with 250 mL of water at 21:00 pm
~A minimum of 4 litres of fluid were recommended throughout the preparation"
16188633|NCT01481714|Drug|Sodium picosulphate/magnesium oxide and citric acid|"The day before the procedure:
~- A sachet mixed with 250 mL of water at 18:00 pm, followed by 2 litres of clear liquids
~The day of the procedure:
~A sachet administered at 5:45 am, followed by 1,5 litres of fluid intake up to 7 am for colonoscopies scheduled from 9 to 11 am.
~A sachet administered at 6:45 am, followed by 1,5 litres of fluid intake up to 8 for colonoscopies scheduled after 11 am."
16188634|NCT01481701|Drug|Oxaliplatin|85 mg/m² / 14days
16188635|NCT01481701|Drug|oxaliplatin|oxaliplatin
16188636|NCT01481688|Other|Exercise|Exercise During Dialysis Patients will be asked to carry out cycling exercise for 60 minutes during the third quarter of their routine haemodialysis session. Exercise can be carried out in ten minute bouts with several minutes rest between bouts.
16188637|NCT01481688|Other|Extra time|An extra 30 minutes will be added to the currently prescribed treatment time of each patient.
16188638|NCT01481662|Device|Diffusion tensor magnetic resonance imaging of the brain|Diffusion tensor magnetic resonance imaging of the brain will be obtained to more carefully study the cerebral microvasculopathy of the disease.
16188639|NCT01481623|Other|Constitution of a biological bank|Blood samples for the constitution of a biobank (DNA, RNA, serum)
16188640|NCT01481623|Other|Metabolic studies|oral glucose tolerance test (OGTT) intravenous glucose tolerance test (IVGTT) hyperglycemic clamp staged glucose perfusion arginine test measure of body composition (BIPHOTONIC absorptiometry, DEXA)
16188641|NCT01481610|Drug|Lumiracoxib|Patients in this group will receive a standard fixed dose of lumiracoxib PO (200 mg/day), for a period no longer than 10 days, but no shorter than 7 days.
16188642|NCT01481610|Drug|Diclofenac|Patients in this group will receive a standard fixed dose of diclofenac PO (100 mg/day) for a period no longer than 10 days but no shorter than 7 days.
16188643|NCT01481597|Drug|deuteporfin|deuteporfin 1 mg/kg IV as a single dose
16188644|NCT01481597|Drug|deuteporfin|deuteporfin 2.5 mg/kg IV as a single dose
16188645|NCT01481597|Drug|deuteporfin|deuteporfin 5 mg/kg IV as a single dose
16188646|NCT01481597|Drug|deuteporfin|deuteporfin 7.5 mg/kg IV as a single dose
16188647|NCT01481597|Drug|placebo|Placebo for 2.5 mg/kg, 5 mg/kg and 7.5mg/kg of deuteporfin (single dose)
16188648|NCT01481584|Dietary Supplement|Protein drink - protein isolate|The subjects consumed 500 mL of a protein drink (tomato juice) containing 30 g protein (canola protein isolate or reference protein) after overnight fasting. After run-in period, each volunteer have to pass both protein-intervention days in different order with a four-week wash out period in between.
16188649|NCT01481584|Dietary Supplement|Protein drink - protein hydrolyzate|The subjects consumed 500 mL of a protein drink (tomato juice) containing 30 g protein (canola protein hydrolyzate or reference protein) after overnight fasting. After run-in period, each volunteer have to pass both protein-intervention days in different order with a four-week wash out period in between.
16188650|NCT01481571|Device|Vitrification medium oocyte, warming medium oocyte and Rapid-i|Media and device for vitrification of human oocytes
16188651|NCT01481558|Device|Transcranial direct current stimulation|tDCS 2 mA, dorsolateral pre-frontal cortex
16188652|NCT01481545|Radiation|Radiation therapy|Radiation therapy will be administered at the total dose of 45 Gy, given with five weekly fractions over a period of 5 weeks. The daily fraction dose will be 1.8 Gy
16188653|NCT01481545|Drug|Oxaliplatin|100 mg/m2 on day 1 every 2 weeks for 3 cycles (for patients with resectable organ metastases (M1), an additional 2 cycles of chemotherapy will be given after radiation therapy)
16188654|NCT01481545|Drug|Raltitrexed|2.5 mg/m2 on day 1 every 2 weeks for 3 cycles (for patients with resectable organ metastases (M1) , an additional 2 cycles of chemotherapy will be given after radiation therapy)
16188655|NCT01481545|Drug|levofolinic acid|250 mg/m2 on day 2 every 2 weeks for 3 cycles (for patients with resectable organ metastases (M1), an additional 2 cycles of chemotherapy will be given after radiation therapy)
16188656|NCT01481545|Drug|5-fluorouracil|800 mg/m2 on day 2 every 2 weeks for 3 cycles (for patients with resectable organ metastases (M1), an additional 2 cycles of chemotherapy will be given after radiation therapy)
16188657|NCT01481545|Drug|Bevacizumab|will be given by intravenous infusion at the dose of 5 mg/kg concurrent with chemotherapy and radiotherapy every 2 weeks for 4 cycles from -14 days to start chemo-radiotherapy (classical schedule) or 4 days before the concurrent administration of chemotherapy and radiation therapy for 2 cycles if the number of TRG1 was not reached in the first stage (statistical design) with the classical schedule (for patients with resectable organ metastases (M1), one additional administration of bevacizumab will be given after radiation therapy)
16188658|NCT01481532|Drug|Crotoxin|Intra patient dose escalation
16188659|NCT01481519|Drug|dexamethasone 0.1%/povidone-iodine 0.4%|dexamethasone 0.1%/povidone-iodine 0.4%
16188660|NCT01481519|Drug|Artificial Tears|artificial tears 1 drop, 4 times per day
16188661|NCT01481506|Procedure|Telemonitoring|Use of wearable sensors for heart rate, haemoglobin oxygen saturation, physical activity, respiratory rate with automatic transmission to the monitoring central.
16188664|NCT01481480|Procedure|Latissimus dorsi tendon transfer|Latissimus dorsi tendon transfer
16188665|NCT01481480|Procedure|Arthroscopic repair|Arthroscopic repair
16188666|NCT01481467|Behavioral|Influenza vaccination implementation strategy|A multi-faceted influenza vaccination implementation strategy
16188667|NCT01481454|Biological|Quadrivalent Influenza Vaccine (split virion, inactivated)|0.5 mL, Intramuscular
16188668|NCT01481454|Biological|Quadrivalent Influenza Vaccine (split virion, inactivated)|0.5 mL, Intramuscular
16188669|NCT01481454|Biological|Quadrivalent Influenza Vaccine (split virion, inactivated)|0.5 mL, Intramuscular
16188670|NCT01481454|Biological|2011 to 2012 Trivalent Influenza Vaccine|0.5 mL, Intramuscular
16188671|NCT01481441|Drug|SonoVue|2.4 ml Bolus Injection by intravenous canule. Multi-repeatable (up to 4 bolus) if necessary.
16188672|NCT01481428|Behavioral|Computer-facilitated HIV intervention|Individuals assigned to the experimental condition will complete the self-directed CARE HIV intervention during each of their first three sessions. The 20 minute intervention sessions involve several components including a brief risk assessment, review of identified risks, structured skill building videos, and the development of a risk prevention action plan. Because of the adaptive nature of the CARE program, the content of each session will be tailored to address the current risks of the participant. While the main focus of the intervention is on risk, individuals who report being HIV infected will receive a referral to treatment if they are not currently receiving medical care and their session will address, among other things, adherence to HIV care.
16188673|NCT01481428|Behavioral|Attention Control|Life skills training DVDs that match the duration of the anticipated experimental condition. The DVDs address topics such as positive listening skills, anger management, and stress reduction.
16188674|NCT01481402|Drug|Liothyronine|Liothyronine 40 microgram per day
16188675|NCT01481402|Drug|Liothyronine|3 months of placebo followed by 3 months of Liothyronine 40 microgram per day (oral)
16188676|NCT01481389|Dietary Supplement|Theobromine|200 ml drink with added theobromine (no cocoa added)
16188677|NCT01481389|Dietary Supplement|Cocoa|200 ml drink with cocoa (no theobromine added)
16188678|NCT01481389|Dietary Supplement|Cocoa and theobromine|200 ml drink with added cocoa and theobromine
16188679|NCT01481389|Dietary Supplement|Placebo|200 ml drink (no added theobromine or cocoa)
16188680|NCT01481363|Behavioral|The Talking Sense manual|Talking Sense is a recently written therapy manual for professionals to use with carers of people with dementia. It is intended to be used one to one with carers and is individualisable according to their relatives degree of communication difficulty or the extent to which the carer experiences difficulty with communication. The approach addresses the carers knowledge, skills, thinking and behaviour in a series of interdependent steps. In this study it will be delivered to carers during 3 home visits and up to a total of 4.5 hours.
16188681|NCT01481363|Behavioral|Treatment as usual - communication information and advice|Carers will receive the existing model of support provided by the speech and language therapy service. This is based on a one hour visit during which questions will be answered and specific advice given. No leaflets or manual will be used.
16188682|NCT01481350|Drug|sildenafil|The patients will receive a dose of 10 mg every 8 hours, for a maximum time of 72 hours.
16188683|NCT01481337|Procedure|Colonic polypectomy or endoscopic mucosal resection (EMR)|Resection of colonic polyps using polypectomy tehnique (with electrocoagulation) or mucosal resection (EMR or mucosectomy) with injection of physiological serum thus resection with electrocoagulation.
16188684|NCT01481311|Device|medical Body Composition Analyzer seca 514/515|Current of 100 µA
16188685|NCT01481311|Procedure|Deuterium and Sodium Bromide dilution methods|Orally administered to the subject in a solution with 100 ml tap water.
16188686|NCT01481272|Drug|Ofatumumab|1000 IV, according to detailed instruction included in the protocol, on day 1 of each 21-day cycle, maximum 6 cycles
16188687|NCT01481272|Drug|Etoposide|60mg/m2 IV, daily over 1 hour, on days 1-5 of 21-day cycle, maximum 6 cycles
16188688|NCT01481272|Drug|Ifosfamid|1500mg/m2 or 1000mg/m2 (patients >/=60 years), IV, daily over 1 hour, on 1-5 days of each 21-day cycle, maximum 6 cycles
16188689|NCT01481272|Drug|Mesna|300mg/m2 or 200mg/m2 (patients >/=60 years), IV, over 1 hour, mixed with ifosfamid then 900mg/m2 or 600mg/m2 (patients >/=60 years)over 12 hour or by local practice, on 1-5 days of each 21 day cycle, maximum 6 cycles
16188690|NCT01481272|Drug|Cytarabine|2g/m2 or 0,5-1g/m2 (patients >/= 60 years), IV, over 3 hours, 12 hourly (total of 4 doses), on days 1-2 of each 21 day cycle, maximum 6 cycles
16188691|NCT01481272|Drug|Methotrexate|12mg, it, on day 5 of each 21 days cycle, maximum 6 cycles
16188692|NCT01481272|Drug|Leukovorin|15mg, po 24 hours after methotrexate it
16188693|NCT01481272|Drug|Granulocyte-Colony Stimulating Factor|5 microgram/kg or 263 microgram ampoule, sc, daily, starting on day 7 of each 21 day cycle, until ANC>1.0x109/l
16188694|NCT01481259|Biological|Autologous cytokine-induced killer cell|Subjects receive autologous cytokine-induced killer cell infusion every 21 days in the absence of disease progression or unacceptable toxicity.
16188695|NCT01481259|Other|Pemetrexed|Subjects receive pemetrexed infusion at a dose of 500mg/m2 every 21 days in the absence of disease progression or unacceptable toxicity.
16188696|NCT01481246|Behavioral|Categorization training|Behavioral intervention consisting of cognitive training exercises to improve categorization performance
16188697|NCT01481246|Behavioral|Psychosocial and Psychoeducational Group training|Group treatment with a focus on psychosocial and psychoeducational intervention in healthy adults and in adults with cognitive decline. Ten week cycle, 2 hours per week group intervention study.
16188698|NCT01481233|Drug|Colchicine|Colchicine 0.6 mg bid to a maximum of 1.2 mg bid
16188699|NCT01481220|Drug|Eltrombopag|In this study 4 different doses of oral eltrombopag (50mg, 100mg, 200mg and 300mg) will be tested. A modified 3+3 patient cohorts design will be used so no new patients are accepted to start on a higher dose without prior tolerance at the previous dose. Patients will be given eltrombopag once daily starting one week before the start of azacitidine treatment and then continue throughout the study, which duration will be approximately 3 months (three Azacytidine cycles). Patients will be evaluated continuously by clinical and laboratory assessments as well as bone marrow examinations during the treatment period until 4 weeks after discontinuation of Eltrombopag. Response, AEs/SAEs and DLTs will be monitored throughout the study.
16188700|NCT01481194|Drug|Doxorubicin|50 mg/m2 IV on day 1 of a 21-day cycle
16188701|NCT01481194|Drug|Bortezomib|1.3 mg/m2 IV push on days 2 and 9 of a 21-day cycle
16188702|NCT01481194|Drug|Lenalidomide|15 mg orally on days 1-14 of a 21-day cycle
16188703|NCT01481194|Drug|Dexamethasone|20 mg orally on days 2, 3, 9, and 10 of a 21-day cycle
16188704|NCT01481194|Drug|Cyclophosphamide|750 mg/m2 IV on day 1 of a 21-day cycle
16188705|NCT01481181|Dietary Supplement|Zinc enriched water|3mg zinc/L of purified water from a filter installed in the households
16188706|NCT01481168|Device|Pacemaker implantation (Medtronic)|DDD+/-R pacing
16188707|NCT01481168|Device|Pacemaker implantation (Medtronic)|ODO pacing
16188708|NCT01481168|Device|Implantable Loop Recorder (Medtronic)|Loop recorder implantation
16188709|NCT01481155|Procedure|ablative CO2 laser therapy|CO2 laser therapy
16188710|NCT01481155|Procedure|photodynamic therapy|Treatment with 5-ALA cream, application time at least 4 h, red light radiation with 76 J/cm²
16188711|NCT01481142|Device|(GMA) Adsorptive Apheresis|Patients will be treated with once-weekly Adacolumn® apheresis over 5 consecutive weeks; treatment can be extended to up to 10 treatments administered once weekly over 10 weeks.
16188712|NCT01481129|Drug|Akt Inhibitor MK2206|Given PO
16188713|NCT01481129|Other|Laboratory Biomarker Analysis|Correlative studies
16188714|NCT01481129|Other|Pharmacological Study|Correlative studies
16188715|NCT01481116|Drug|TAK-875|TAK-875 25 mg, tablets, orally, once daily and metformin ≥1500 mg or Maximum Tolerated Dose (MTD) for up to 104 weeks.
16188716|NCT01481116|Drug|TAK-875|TAK-875 50 mg, tablets, orally, once daily and metformin ≥1500 mg or MTD for up to 104 weeks.
16188717|NCT01481116|Drug|Glimepiride|Glimepiride 1 mg, tablets, orally, once daily (up-titrated to 2 mg after 1 week of treatment. Up-titrated to a maximum of 6 mg in 2 mg increments/down titrated if recurrent (or severe) hypoglycemia occurs) and metformin ≥1500 mg or MTD for up to 104 weeks.
16188718|NCT01481103|Procedure|Acupuncture|participants will receive 8 weekly acupuncture sessions. Acupuncture will be performed by a licensed acupuncturist. Each session will last approximately 25 minutes.
16188719|NCT01481090|Procedure|Acupuncture, Electro-Acupuncture|Participants will receive 4 Electro-acupuncture stimulation applied to acupoints SP-6, Zi-Gong, CV-3 and CV-4acupuncture treatments during hormone treatment.
16188720|NCT01481077|Drug|Latanoprost-PPDS|Sustained release for 12 weeks
16188721|NCT01481064|Behavioral|Multifaceted approach|Audit and feedback, educational outreach visits, and patient-mediated interventions.
16188722|NCT01481051|Drug|Latanoprost-PPDS|Sustained delivery for 12 weeks
16188723|NCT01481025|Drug|Cimicifuga + Hiperico|"1 tablet, 80+450mg/tablet, twice a day for 1-3 months
~1 tablet, 80+450mg/tablet, once a day for 3-6 months"
16188724|NCT01481025|Drug|Cimicifuga Herbarium|"2 caps, 80mg/caps, once a day for 1-3 months
~1 caps, 80mg/caps, once a day for 3-6 months"
16188725|NCT01481025|Drug|Aplause®|4 tablets, 20mg/tablet, twice a day for 1-3 months 2 tablets, 20mg/tablet, twice a day for 3-6 months
16188726|NCT01480986|Drug|Irinotecan combined with cisplatin, octreotide lar|Phase 1 irinotecan 180mg/m^2，ivgtt，90min，D1 Cisplatin 50 mg/m^2，ivgtt，120min，D1（with hydration） Phase 2 Octreotide 0.1mg，ih，q8h，D1-14 Octreotide lar 20mg，deep i.m，D8，
16188727|NCT01480973|Radiation|Stereotactic Body Radiation Therapy|SBRT involves highly precise delivery of very high dose Radiotherapy (RT) over a very few fractions (hypofractionation) to accurately delineated, size-restricted malignant targets in which motion has been accounted for during the delivery process. SBRT administration achieves avoidance of normal tissue exposure to radiation during the planning process, by providing for sharp fall-off dose gradients outside the target.
16188728|NCT01480960|Other|Pulmonary rehabilitation + whole body vibration training|standard inpatient rehabilitation program including endurance and strength plus squats on a vibration plate for 4x2 minutes, 3 times per week
16188729|NCT01480947|Drug|Bio-three|oral Bio-three three times daily for 7 days, Bio-three dosage plan: 1) patients aged 6 years old, 1 tablet t.i.d.; 2) patients aged between 6 and 12 years old, 2 tablets t.i.d.; 3) patients aged 12 years old, 3 tablets t.i.d.
16188730|NCT01480921|Behavioral|Home-based exercise training|"Participants in the home-based group will be advised to exercise, a minimum of 3 times per week, but will be encouraged to exercise a total of 5-7 days per week as per CACR and ACSM guidelines. Prescriptions will include the same elements of those for the hospital group:
~5-10 min warm-up
~30 min aerobic interval training (walking or stationary bicycle)
~10 min cool-down
~Home-based participants will be asked to record their exercise in an exercise log book and will receive bi-weekly telephone calls from exercise personnel to monitor progress, assess and document adherence, revise the exercise prescription if necessary and provide support and education. Patient safety will be monitored during each call and serious health concerns will be relayed, with the patient's permission, to their primary health provider. Patients in this group will be encouraged to call the exercise specialist or kinesiologist with concerns or questions throughout the study."
16188731|NCT01480921|Behavioral|Supervised hospital-based exercise training|"Patients in the hospital-based group will participate in supervised, on-site, group exercise sessions 3 times per week, but will be encouraged to exercise a total of 5-7 days per week as per CACR and ACSM guidelines. Trained exercise personnel (kinesiologists and exercise specialists) will supervise these sessions. Exercise sessions will include:
~5-10 min of warm-up
~30 min of aerobic interval training using stationary cycles, treadmills and arm ergometers
~10 min of cool down
~Exercise will be tracked by the participant in exercise log books."
16188732|NCT01480908|Procedure|Echocardiography at rest|Dimensions of all 4 chambers, inspiratory collapse, and gradient over the tricuspid valve is measured. Tricuspid Annulus Plane Systolic Excursion(TAPSE) and Tricuspid Annular peak Systolic Motion(TASM) is measured as well.
16188733|NCT01480908|Procedure|Echocardiography during exercise|TASM is measured during exercise along with pulse measurements to evaluate the force-frequency-relation.
16188734|NCT01480908|Procedure|MRI at rest|Dimensions of all 4 chambers are measured at end-systole and end-diastole. Blood flow measurements through the aortic and the pulmonary valve are made as well. No use of contrast.
16188735|NCT01480908|Procedure|Exercise testing|Maximal oxygen consumption is measured during on a bicycle. Prior to the test a spirometry is performed to rull out potential differences in pulmonary function between the cohorts. During the test pulse, blood pressure, saturation, and EKG are monitored. Ventilatory volume, oxygen consumption and carbon dioxide excretion are measured. Anaerobic threshold is calculated at the end of the test.
16188736|NCT01480895|Behavioral|Lifestyle instruction for Jews and Bedouin GDM women.|Every several months the women had instructions and checkups.
16188737|NCT01480882|Procedure|Conventional Chest Physiotherapy (CCPT)|Conventional chest percussion will be applied for a duration of 15 minutes.
16188738|NCT01480882|Device|Mechanical percussion (LEGA)|Mechanical chest percussion will be delivered by a device for 15 minutes.
16188739|NCT01480869|Drug|calcium and cholecalciferol|Tablet to suck: calcium 500 mg bid, cholecalciferol 200 IU bid
16188740|NCT01480869|Drug|calcium and cholecalciferol|"Tablet: calcium 500 mg bid + 2 ml drinkable solution cholecalciferol 100 000 IU whose schedule of administration depends on vitamin deficiency level:
~100 000 IU of vitamin D3 at D1, D15, D28 and D43 if 25-OHD level < 10 ng/mL
~100 000 IU of vitamin D3 at D1, D15, D28 if 10 ng/mL ≤ 25-OHD level < 20 ng/mL
~100 000 IU of vitamin D3 at D1 if 20 ng/mL ≤ 25-OHD level < 30 ng/mL"
16188741|NCT01480856|Procedure|Cobedding|Newborn twins are settled in a singe bed: this is cobedding
16188742|NCT01480856|Procedure|Single-bedding|Newborn twins are settled in two single beds : this is single-bedding
16188743|NCT01480843|Drug|Glargine|Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults
16188744|NCT01480830|Device|Magnetic Endoscopic Imaging (MEI) colonoscopy|Colonoscopy using the Scope Guide system (Olympus Canada Inc.) by
16188745|NCT01480817|Drug|Sorafenib|Sorafenib 400mg po bid
16188746|NCT01480817|Procedure|TACE for HCC with portal vein invasion|The volume of iodized oil ranged from 2 to 12 mL, and the amount of doxorubicin ranged from 10 to 60 mg. Gelatin sponge particles were mixed with mitomycin and contrast material.Cisplatin was infused at the tumor feeder vessels as a solution with a concentration of 0.5 mg/mL at a rate of 5-10 mL/min. The total amount of cisplatin used ranged from 50 to 100 mg depending on the patient's body weight and the level of infusion.
16188747|NCT01480804|Other|Intervention for age specific barriers to self care|The intervention included developing strategies to help patients cope with their barriers to self care. The intervention were implemented by care manager over 6 month period in person and by phone calls. During the six to twelve month period subjects did not have any contact with study staff or care manager.
16188748|NCT01480791|Drug|Aliskiren vs. hydrochlorothiazide|Aliskiren will be used at increasing doses from 150 to 300 mg per day for 6-12 months.
16188749|NCT01480791|Drug|Hydrochlorothiazide|Hydrochlorothiazide will be used at increasing doses from 12.5 to 25 mg per day for 6-12 months.
16188750|NCT01480778|Drug|LNG+EE2|Administration of one pill contained 0.15 mg of levonosgestrel and 0.03 mg of ethynil estradiol per day over 21 days.
16188751|NCT01480778|Drug|Nordette|Administration of one pill contained 0.15 mg of levonosgestrel and 0.03 mg of ethynil estradiol per day over 21 days.
16188752|NCT01480765|Drug|Pregabalin|150mg (2hrs) pre operatively and twice daily post operatively for 10 days, followed by dose reduction to 75mg twice daily for 2 days and finally to 50 mg twice daily for 2 days
16188753|NCT01480765|Drug|Ketamine infusion|0.1mg/kg/hr for 48 hours post operatively
16188754|NCT01480765|Drug|Placebo capsules|Single capsule (2hrs) pre operatively and twice daily post operatively for 10 days, followed by dose reduction to single capsule twice daily for 2 days and finally to single capsule twice daily for 2 days
16188755|NCT01480765|Drug|Placebo infusion|Normal saline placebo intravenous infusion for 48 hours
16188756|NCT01480752|Drug|Lornoxicam|PDL injection of 0/2 ml of lornoxicam (4mg/ml),before the root therapy and after the inferior alveolar injection
16188757|NCT01480752|Drug|normal saline|PDl injection of 0/2 ml normal saline before the root therapy and after inferior alveolar injection
16188758|NCT01480752|Drug|no injection|inject nothing after inferior alveolar injection and before root canal therapy
16188759|NCT01480739|Drug|100 mg (50 mg x 2) AZD5069|Twice daily for 7 days
16188760|NCT01480739|Drug|100 mg Placebo|Twice daily for 7 days
16188761|NCT01480726|Procedure|Surgery|
16188762|NCT01480713|Drug|Isentress® (Raltegravir, 400 mg every 12 hours)|Lopinavir/r 200/50 mg every 12 hours + Raltegravir 400 mg every 12 hours
16188763|NCT01480713|Drug|Isentress® (Raltegravir, 400 every 12 hours)|Darunavir/rit 800/100 mg every 24 hours + Raltegravir 400 mg every 12 hours
16188764|NCT01480700|Other|Nutritional study|subjects consume 2 eggs per day during 4 months
16188765|NCT01480687|Dietary Supplement|DHA-EPA|1800 mg/day
16188766|NCT01480687|Drug|Ciprofibrate|100 mg/day
16188767|NCT01480674|Drug|Trastuzumab|
16188768|NCT01480661|Drug|Roflumilast|Roflumilast 500 µg, once a day in the morning during 6 months
16188769|NCT01480661|Drug|Placebo of Roflumilast|Placebo 500 µg, once a day in the morning during 6 months
16188770|NCT01480661|Radiation|Functional Respiratory Imaging|CT scan of thorax, at baseline and after 6 months
16188771|NCT01480648|Drug|BI 144807 Placebo|Placebo that represents BI drug
16188772|NCT01480648|Drug|BI 144807|single dose (low to high dose)
16188773|NCT01480622|Drug|TDF tablets|"White, almond-shaped, film-coated tablets, one side with the markings GILEAD and 4331"
16188774|NCT01480609|Drug|Retigabine / Ezogabine|Retigabine / Ezogabine will be available as immediate release tablets of 50 milligrams strength. Subjects will be administered the tablet will 250 milliliters of water
16188775|NCT01480596|Biological|Belimumab|10mg/kg IV infusion
16188776|NCT01480596|Other|Placebo|placebo IV infusion
16188777|NCT01480583|Drug|GRN1005|550 mg/m2 IV every 3 weeks
16188778|NCT01480583|Drug|Trastuzumab|2 mg/kg IV every week or 6 mg/kg IV every 3 weeks per investigator choice
16188779|NCT01480583|Drug|18F-FLT|5 mCi of 18F-FLT IV during Screening and during Cycle 1
16188780|NCT01480557|Procedure|liquefaction|Cataract extraction surgery type
16188781|NCT01480557|Procedure|Torsional ip|A type cataract surgery using torsional ip technology
16188782|NCT01480544|Other|Experimental: Treatment 1|Physicians will receive financial incentives for improving the quality of obstetric and neonatal care provided to mothers and newborns as reported by mothers during household interviews.
16188783|NCT01480544|Other|Experimental: Treatment 2|Physicians will receive financial incentives for improving maternal and neonatal health outcomes as reported by mothers during household interviews.
16188827|NCT01480271|Drug|4000ng GSK2445053|4000ng GSK2445053 administered intranasally
16188828|NCT01480271|Drug|Placebo|Placebo administered intranasally
16188784|NCT01480531|Drug|Clevidipine|"Clevidipine administration begins in the ER or ICU
~Clevidipine is again administered post op when blood pressure control is required.
~Clevidipine will be administered by an infusion pump via either a central line or a peripheral IV as follows:
~Clevidipine will be initiated at an infusion rate of 0.4 μg•kg-1•min-1 and will be titrated as tolerated in doubling increments every 90 s up to 3.2 μg•kg-1•min-1.
~Infusion rates above 3.2 μg•kg-1•min-1 will be guided by the patient's response and permitted in serial increments of 1.5 μg•kg-1•min-1.
~Infusion rates between 4.4 and 8.0 μg•kg-1•min-1 will be administered for no longer than 2 h.
~As blood pressure approaches goal, increase dose by less than double and lengthen time between does adjustments to every 5-10 minutes (a 1-2 mg/hr increase will generally result in a 2-4 mm Hg reduction in SBP)"
16188785|NCT01480518|Genetic|DNA analysis|
16188786|NCT01480518|Genetic|comparative genomic hybridization|
16188787|NCT01480518|Genetic|gene expression analysis|
16188788|NCT01480518|Genetic|mutation analysis|
16188789|NCT01480518|Genetic|polymerase chain reaction|
16188790|NCT01480518|Genetic|polymorphic microsatellite marker analysis|
16188791|NCT01480518|Other|laboratory biomarker analysis|
16188792|NCT01480505|Procedure|Pars plana vitrectomy with gas tamponade|"A standard three-port 20 Gauge vitrectomy under a wide-angle-viewing contact lens was performed. Peripheral vitreous shaving was completed under slit-lamp illumination without contact lens by gentle scleral indentation. Posterior hyaloid detachment was checked and completed if necessary without dye. The epiretinal membrane removal or internal limiting membrane (ILM) peeling was performed if necessary. In general this latter procedure was not conducted for RD secondary to peripheral retinal tears without any sign of PVR or ERM but was done in almost all cases related to posterior break.
~Subretinal fluid was aspirated through the retinal tear, the MH, the PVT or through a retinotomy to obtain a complete peroperative retinal reattachment."
16188793|NCT01480492|Drug|Telbivudine|600mg,1/d,one year
16188794|NCT01480479|Drug|Rindopepimut (CDX-110) with GM-CSF|"Two intradermal injections two weeks apart, followed by monthly injections until tumor progression or intolerance.
~Each dose will be 0.8 mL containing approximately 500 mcg CDX-110 and 150 mcg GM CSF."
16188795|NCT01480479|Drug|Temozolomide|150 to 200 mg/m2 for 5 days during each 28-day cycle for a minimum of six cycles or a maximum of 12 cycles, or until intolerance or progression.
16188796|NCT01480479|Drug|KLH|Two intradermal injections two weeks apart, followed by monthly injections until tumor progression or intolerance. Each dose will be 0.8mL containing approximately 100mcg of KLH.
16188797|NCT01480466|Other|Obesity tools in the electronic health record|The intervention is a set of new tools within the Partners electronic health record that are designed to assist primary care clinicians with the assessment and management of overweight and obesity in their patients.
16188798|NCT01480453|Device|Trabecular Metal Humeral Stem|Trabecular Metal Humeral Stem used in primary, total or hemi shoulder arthroplasty
16188799|NCT01480440|Device|Trabecular Metal Reverse Shoulder System|Trabecular Metal Reverse Shoulder System used in primary or revision total shoulder arthroplasty
16188800|NCT01480414|Biological|4times injection|bone marrow derived mono nuclear stem cell
16188801|NCT01480414|Biological|stem cell transplantation|Mono nuclear stem cell transplantation by intra muscular injection to the ischemic lower limb
16188802|NCT01480401|Other|low-sodium diet (1500 mg daily)|
16188803|NCT01480388|Drug|Placebo/JNJ-39758979 (300 mg/d)|Form = tablet, route = oral adminstration placebo once daily from Week 0 to Week 24 followed by JNJ-39758979 300 mg once daily from Week 24 to Week 48.
16188804|NCT01480388|Drug|JNJ-39758979 (10 mg)|Form = tablet, route = oral adminstration once daily up to 48 weeks
16188805|NCT01480388|Drug|JNJ-39758979 (30 mg)|Form = tablet, route = oral adminstration once daily up to 48 weeks
16188806|NCT01480388|Drug|JNJ-39758979 (100 mg)|Form = tablet, route = oral adminstration once daily up to 48 weeks
16188807|NCT01480388|Drug|JNJ-39758979 (300 mg)|Form = tablet, route = oral adminstration once daily for 48 weeks
16188808|NCT01480375|Device|Smartbx™ system.|The SmartBx™ system semi-automated downloads the biopsy cores from the biopsy needle onto a designated cassette which integrates into the routine pathology lab processing. The core is downloaded in an oriented and straightened fashion while preserving core fragments in its original locations relative to the needle notch.
16188809|NCT01480362|Device|Negative Pressure Wound Therapy|"Used therapy systems:
~KCI. V.A.C. Freedom; Acti V.A.C.; INFO V.A.C. to be used with the V.A.C. Granufoam (black), V.A.C. Granufoam Silver and V.A.C. WhiteFoam Smith & Nephew: Renasys GO and Renasys EZ Plus to be used with the Renassys-F/P and Renassys-G Use of the medical devices and applicable consumption items according to manufacturers guidelines and FDA regulations."
16188810|NCT01480362|Other|Standard Wound Therapy|Standard wound therapy according to current evidence-based guideline(basic and advanced methods of wound treatment)
16188811|NCT01480336|Drug|Amiodarone Plus Ranolazine|Ranolazine 500mg by mouth twice daily
16188812|NCT01480336|Drug|Amiodarone with Placebo|stabel dose of amiodarone as prescribed by cardiologist
16188813|NCT01480323|Drug|Interleukin-2|intratumoral injections of 9 MIU/day on days 1, 4, 8, 11, 15, 18, 22 and 25. The administered dose will be distributed between all injectable soft-tissue metastases
16188814|NCT01480323|Drug|Ipilimumab|IV infusion, 3 mg/kg, day 2, 23, 44, 65
16188815|NCT01480310|Drug|MCAF5352A|may receive up to 3 subcutaneous doses of MCAF5352A
16188816|NCT01480310|Drug|Placebo|may receive up to 3 subcutaneous doses of placebo
16188817|NCT01480297|Drug|Salsalate|Salsalate 3 grams daily (1 gram TID with meals)
16188818|NCT01480284|Drug|GSK548470 300 mg tablet|Blue tablets, each tablet containing 300 mg of tenofovir disoproxil fumarate
16188819|NCT01480284|Drug|ETV 0.5 mg capsule|Brown capsules, each capsule containing 0.53 mg of entecavir hydrate
16188820|NCT01480271|Drug|2 ng GSK2445053|2ng GSK2445053 administered intranasally
16188821|NCT01480271|Drug|20ng GSK2445053|20ng GSK2445053 administered intranasally
16188822|NCT01480271|Drug|100ng GSK2445053|100ng GSK2445053 administered intranasally
16188823|NCT01480271|Drug|200ng GSK2445053|200ng GSK2445053 administered intranasally
16188824|NCT01480271|Drug|400ng GSK2445053|400ng GSK2445053 administered intranasally
16188825|NCT01480271|Drug|1000ng GSK2445053|1000ng GSK2445053 administered intranasally
16188826|NCT01480271|Drug|2000ng GSK2445053|2000ng GSK2445053 administered intranasally
16188829|NCT01480258|Biological|PR5I|DTaP-HB-IPV-Hib (Diphtheria, tetanus, pertussis [acellular, component], hepatitis B [recombinant DNA], polio virus [inactivated], and Haemophilus influenza type b conjugate vaccine [adsorbed]) Vaccine 0.5 mL intramuscular injection at 2, 4, and 11 to 12 months of age. Injection is to be administered in the upper anterolateral thigh, separate limb from the concomitant vaccine. PR5I is a liquid suspension hexavalent vaccine.
16188830|NCT01480258|Biological|Rotavirus vaccine|Rotarix™ 1.5 mL oral dose at 2 and 4 months of age (subset 1, Italy and Sweden) or RotaTeq™ 2 mL oral dose at 2, 4 and 5 months of age (subset 2, Finland)
16188831|NCT01480258|Biological|Prevenar 13™|Prevenar 13™ 0.5 mL intramuscular injection at 2, 4, and 11 to 12 months of age. Injection is to be administered in the upper anterolateral thigh, separate limb from the concomitant vaccine.
16188832|NCT01480258|Biological|INFANRIX™ hexa|Combined Diphtheria-Tetanus-acellular Pertussis [DTaP], Hepatitis B [HepB], Poliovirus [IPV] and Haemophilus influenzae type b [Hib] Vaccine 0.5 mL intramuscular injection at 2, 4 and 11 to 12 months of age. Injection is to be administered in the upper anterolateral thigh, separate limb from the concomitant vaccine. INFANRIX™ hexa is provided as 2 components (lyophilized Hib and liquid DTaP, IPV, and HepB). Prior to administration, the vaccine must be reconstituted by adding the liquid DTaP-HepB-IPV component to the vial containing the Hib pellet.
16188833|NCT01480245|Drug|GSK2402968|6mg/kg/week
16188834|NCT01480232|Drug|EVP-6124|One EVP-6124 capsule ingested orally daily for 12 weeks (84 days)
16188835|NCT01480232|Drug|Placebo Capsule|One placebo capsule ingested orally daily for 12 weeks (84 days)
16188836|NCT01480232|Drug|NicoDerm Patch (Active)|One NicoDerm patch once daily for first 6 weeks (42 days). Dosage will taper from 21 mg (Weeks 1-3) to 14 mg (Weeks 4-5) to 7 mg (Week 6).
16188837|NCT01480232|Drug|NRT Patch (Placebo)|One NRT patch (Placebo) daily for first 6 weeks (42 days).
16188838|NCT01480232|Behavioral|Brief Supportive and Behavioral Treatment|Brief, standard, manualized individual cognitive behavioral therapy intervention will be based on the Freedom from Smoking curriculum from the American Lung Association.
16188839|NCT01480219|Drug|voriconazole (Vfend)|Voriconazole utilization was identified as any vs. none for the period 180 days before and 180 days after the date of transplant.
16188840|NCT01480219|Other|no voriconazole (Vfend)|Voriconazole utilization was identified as any vs. none for the period 180 days before and 180 days after the date of transplant.
16188841|NCT01480206|Other|Endovascular Aortic Repair (EVAR)|Use of 3D interventional imaging tools in endovascular procedures in the surgical environment
16188842|NCT01480193|Other|Sound Based and Educational Therapies|The SBE program will consist of two hour-long individual counseling and sound therapy sessions based on the Department of Veterans Affairs Progressive Audiologic Tinnitus Management approach. SBE treatment incorporates the use of education, counseling, increased relaxation and decreased stress, along with the integration of sound therapy to better manage the impact of tinnitus.
16188843|NCT01480193|Other|Integrative Medicine Therapies and Sound Based Education Therapies|3 Cognitive Based Therapy Sessions, 9 Telephonic Health Coaching Sessions, 5 Acupuncture Sessions, and Group-Based 8 week Mindfulness Based Stress Reduction Provided synergistically through an integrative medicine paradigm
16188844|NCT01480180|Drug|turoctocog alfa pegol|Administered i.v.
16188845|NCT01480167|Device|Vertebral Augmentation (STABILIT)|Vertebral Augmentation with the STABILIT Vertebral Augmentation System
16188846|NCT01480167|Other|Non-operative Management|Conservative Care
16188847|NCT01480154|Drug|Akt Inhibitor MK2206|Given PO
16188848|NCT01480154|Drug|Hydroxychloroquine|Given PO
16188849|NCT01480141|Drug|BIBW 2992 (Afatinib)|Patients will receive treatment with afatinib 40mg orally daily for a minimum of 2 weeks
16188850|NCT01480128|Procedure|Single-port|Single-port laparoscopic colon resection
16188851|NCT01480128|Procedure|Multi-port|Multi-port laparoscopic colon resection
16188852|NCT01480115|Other|ultrasound examination for AFC evaluation|Ultrasound examination three times during the menstrual cycle to measure the AFC.
16188853|NCT01480102|Drug|Group A-Paravertebral block|Bupivicaine 0.5% without epinephrine (100mg)20cc will be injected into the T10 paravertebral space. Active Group
16188854|NCT01480102|Other|Group B- No block|direct pressure for 5 minutes will be held at the site of the where the local anesthetic was applied to mimic the application of the block.
16188855|NCT01480089|Drug|Intraperitoneal Ropivacaine (AIR)|Ropivacaine 2 mg/kg per lean body mass up to no more than 200mg total dose will be atomized and delivered into the peritoneal cavity at the completion of surgery.
16188856|NCT01480089|Drug|Atomized Intraperitoneal Saline (AIS)|Atomized saline will be administered to the peritoneal cavity at the completion of surgery.
16188857|NCT01480076|Drug|Fampridine|Supplied as a 10 mg twice daily tablet and taken twice daily. Doses must be spaced at least 12 hours apart.
16188858|NCT01480063|Drug|Fampridine|Fampridine administered as prescribed in routine clinical practice. Biogen is not supplying drug for this study.
16188859|NCT01480050|Drug|temozolomide|standard of care drug
16188860|NCT01480050|Other|3'-deoxy-3'-[18F]fluorothymidine|tracer used for FLT PET CT
16188861|NCT01480050|Other|pharmacological study|
16188862|NCT01480050|Drug|Mibefradil|
16188863|NCT01480011|Drug|lactobacillus CD2 lozenges|The study drug contains not less than 2x109 (2 billion) viable cells of Lactobacillus CD2 as active ingredient
16188864|NCT01479998|Other|standard care|standard care plus nicotine replacement therapy
16188865|NCT01479998|Other|standard care plus contingency management|standard care is 4 counseling sessions and nicotine replacement therapy plus 3 weekly meetings with positive reinforcers
16188866|NCT01479985|Other|CDM Tool|Participants will be required to complete the CDM tool and receive a tailored print out of their contraceptive options based on survey answers
16188867|NCT01479972|Biological|VPM1002|Tuberculosis vaccine
16188868|NCT01479972|Biological|BCG|commercially available live vaccine BCG
16188869|NCT01479959|Device|Eole 3 ventilator - Resmed|positive end expiratory pressure is added to the ventilation mode and it is activated by a switch under patient's control
16188870|NCT01479946|Drug|Electrochemotherapy|bleomycin together with electroporation
16188871|NCT01479933|Dietary Supplement|Vitamin D3|Vitamin D3 40 micrograms (1600 IU) per day
16188872|NCT01479933|Dietary Supplement|Placebo|Inactive placebo
16188873|NCT01479933|Dietary Supplement|Vitamin D 80|Vitamin D3 80 micrograms (3200 IU) per day
16188874|NCT01479920|Drug|Fluoxetine|Subjects of both study arms received orally administered SSRIs for 4 weeks in an open manner. For those who were currently under antidepressant treatment, they would continue the existing treatment regimens. For those who were not medicated at the time of trial, fluoxetine (FLX) was given at an initiate dose of 10 mg/day and escalated to an optimal dose within one week, based on individual response, but the maximum dose was set at 40 mg/day.
16188875|NCT01479920|Procedure|DCEAS (Hwato®/ Dongbang®)|"Six pairs of cranial acupoints are used: Baihui (Du-20) and Yintang (EX-HN3), left Sishencong (EX-HN1) and Toulinqi (GB15), right Sishencong (EX-HN1) and Toulinqi (GB15), bilateral Shuaigu (GB8), bilateral Taiyang (EX-HN5), and bilateral Touwei (ST8). All these acupoints are located on the forehead.
~Disposable acupuncture needles (Hwato®/ Dongbang®, 0.30 mm in diameter and 25-40 mm in length) are inserted at a depth of 10-30 mm obliquely into acupoints, on which low- and high-frequency alternating electrical stimulation with continuous waves is conducted for 30 min. The intensity is adjusted to a level at which patients feel comfortable."
16188876|NCT01479920|Procedure|n-CEA (Strietberger®)|Streitberger's acupuncture needles will be applied on the same acupoints, with the same electrical stimulation parameters, except that the needles only adhere to the skin instead of insertion.
16188877|NCT01479907|Dietary Supplement|Synbiotics|12 gr in 250 cc of water once daily X 15 days
16188878|NCT01479907|Dietary Supplement|Placebo|12 gr in 250 cc of water once daily X 15 days
16188879|NCT01479881|Drug|tacrolimus|a single 2-mg dose of tacrolimus (on Day 1 in treatment C and on Day 7 in treatment D).
16188880|NCT01479881|Drug|TMC435|TMC435, 150 mg daily for 12 days (Days 1 to 12 in treatment D).
16188881|NCT01479881|Drug|cyclosporine|A single 100-mg dose of cyclosporine (on Day 1 of treatment A and on Day 7 of treatment B).
16188882|NCT01479881|Drug|TMC435|TMC435, 150 mg daily for 10 days (Day 1 - 10 in treatment B).
16188883|NCT01479868|Drug|TMC435|TMC435 150 mg will be administered once daily for 12 weeks along with peginterferon alpha-2a and ribavirin.
16188884|NCT01479868|Drug|Pegylated interferon alpha-2a|Pegylated interferon alpha-2a 180 microgram will be administered as subcutaneous injection of 0.5 mL until 24 to 48 weeks.
16188885|NCT01479868|Drug|Ribavirin|Ribavirin 1000 or 1200 mg twice daily will be administered each day until 24 to 48 weeks.
16188886|NCT01479842|Drug|BTK inhibitor PCI-32765|Given PO
16188887|NCT01479842|Biological|rituximab|Given IV
16188888|NCT01479842|Drug|bendamustine hydrochloride|Given IV
16188889|NCT01479842|Other|pharmacogenomic studies|Correlative studies
16188890|NCT01479842|Other|pharmacological study|Correlative studies
16188891|NCT01479842|Other|laboratory biomarker analysis|Correlative studies
16188892|NCT01479829|Drug|ESC + CBX|Escitalopram (ESC) 10 mg twice day given orally twice a day plus Celecoxib (CBX) 200 mg twice daily.
16188893|NCT01479829|Drug|ESC + PBO.|• Escitalopram (ESC) 10 mg twice per day plus Placebo (PBO)administered twice daily.
16188894|NCT01479829|Drug|ESC+CBX|• Escitalopram 10 mg given twice day plus Celecoxib 200 mg twice daily.
16188895|NCT01479803|Procedure|Puncture with fine needle aspiration under endoscopic ultrasonographic control|Puncture of the pancreatic solid mass with fine needle aspiration under endoscopic ultrasonographic control Passage in the same pancreatic mass of first EchoTip HD Procore then EchoTip 22 Gauge or vice versa according to the randomization
16188896|NCT01479790|Device|EyeGiene|The eye mask with a temperature of not more than 40 deg C (confirmed by thermometer) will be worn by the volunteer for 5 minutes.
16188897|NCT01479777|Device|FES Stepping (RT600 from Restorative Therapies, INC.)|You will be transferred to the RT600 device and secured in a support harness. We will place your legs onto the RT600 device and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs, buttock, stomach, and back. The pads will be connected to a stimulator box through a wire. We will then start the stepping motor and stimulate your muscles with electric current. This will cause your legs to step. You will do this for 1 hour.
16188898|NCT01479764|Drug|Sugammadex|sugammadex, intravenous (IV) bolus, 2 or 4 mg/kg depending on level of neuromuscular recovery
16188899|NCT01479764|Drug|Neostigmine|neostigmine, per usual practice
16188900|NCT01479764|Drug|Glycopyrrolate|glycopyrrolate per usual practice
16188901|NCT01479751|Drug|Magnesium Sulfate|Patients receive MgSO4 50 mg/kg for 10 min before injection of Roc 0.6 mg/kg.
16188902|NCT01479751|Drug|Ketamine|patients receive ketamine 0.5 mg/kg 2 min before Roc injection.
16188903|NCT01479751|Drug|rocuronium|Patients receive Roc 0.06 mg/ kg as a priming dose 3 min before injection of Roc 0.54 mg/kg.
16188904|NCT01479738|Procedure|Capitate bone grafting|Capitate bone graft transfer for PIP joint reconstruction
16188905|NCT01479725|Procedure|HBOT|HBOT
16188906|NCT01479712|Procedure|Normal Saline Irrigation|Irrigation with warm normal saline into the abdominal cavity. Approximately 500-1000cc.
16188907|NCT01479699|Dietary Supplement|Olive leaf extract capsules|Four capsules taken at baseline each containing 4mg oleuropein
16188910|NCT01479673|Dietary Supplement|Indirect Calorimetry measurement of Resting Energy Expenditure .|Patients in this group will receive enteral nutrition/parenteral nutrition or combination of enteral and parenteral nutrition according to the individual energy requirements calculated by Indirect Calorimetry.
16188911|NCT01479660|Other|Control|Placebo will be orally administered daily for a period of 12 weeks in high dose and low dose
16188912|NCT01479660|Drug|Probiotic|Probiotic Capsules (450 billion CFU) will be orally administered daily for a period of 12 weeks and Probiotic in higher dose of (3600 billion CFU) will be administered daily for a period of 12 weeks
16188913|NCT01479647|Drug|PH-797804|Tablet, 1 mg, single dose
16188914|NCT01479647|Drug|PH-797804|Tablet, 1 mg, single dose
16188915|NCT01479647|Drug|PH-797804|Tablet, 10 mg, single dose
16188916|NCT01479647|Drug|PH-797804|Tablet, 10 mg, single dose
16188917|NCT01479647|Drug|PH-797804|Tablet, 24 mg, single dose
16188918|NCT01479634|Drug|Standard ART|Standard Ugandan 3-drug antiretroviral therapy regimen consistent with current practices
16188919|NCT01479634|Drug|Study-Provided ART|"Study provided drugs:
~Truvada® (one tablet PO daily of fixed dose combination consisting of tenofovir disoproxyl fumarate [TDF] and emtricitabine [FTC]) PLUS
~Efavirenz [EFV]"
16188920|NCT01479621|Drug|Fp MDPI|"Fp MDPI is an inhalation-driven multidose dry powder inhaler (MDPI) containing fluticasone propionate (Fp) dispersed in a lactose monohydrate excipient and contained within a reservoir. A metered dose of drug is delivered to a dose cup via an air pulse activated when the cap is opened.
~During the treatment period, participants were randomized to 12.5, 25, 50 or 100 mcg of Fp one inhalation twice a day for a total daily dose of 25, 50, 100 or 200 mcg. Study drug was administered in the morning and in the evening"
16188921|NCT01479621|Drug|Flovent Diskus|Flovent Diskus contains the active ingredient fluticasone propionate (Fp). Flovent Diskus 100 mcg was used twice a day, once in the morning and evening, for a total daily dose of 200 mcg of Fp. This therapy was not blinded as the inhaler device was different than the MDPI used in the other treatment arms.
16188922|NCT01479621|Drug|albuterol/salbutamol|A short-acting β2-adrenergic agonists (SABA), albuterol/salbutamol hydrofluoroalkane (HFA) metered dose inhaler (MDI), was provided to be used as needed for the relief of asthma symptoms during both the run-in and treatment periods (to replace the subject's current rescue medication).
16188923|NCT01479621|Drug|Placebo MDPI|Placebo multidose dry powder inhaler in the morning and evening. Placebo MDPI was provided in devices identical in appearance to Fp MDPI.
16188924|NCT01479608|Procedure|Liver transplantation and liver resection|
16188925|NCT01479595|Drug|QBX258|QBX258 infusion, a combination of VAK694 and QAX576, was supplied to the Investigator as open label bulk medication. The planned dose of VAK694 (lyophilisate in vial, 150 mg/vial), was 3 mg/kg. The planned dose of QAX576 (lyophilisate in vial, 150 mg/vial), was 6 mg/kg.
16188926|NCT01479595|Drug|Placebo|The placebo infusion was an equal volume of 5% dextrose for infusion and was provided by the clinical site.
16188927|NCT01479582|Drug|Access to unlicensed cord blood units|
16188928|NCT01479569|Procedure|Pericardiocentesis|
16188929|NCT01479556|Drug|Pregabalin|Pregabalin Alpha2-delta calcium channel blocker. 150mg BID p.o.
16188930|NCT01479556|Drug|Placebo|150mg BID p.o.
16188931|NCT01479543|Other|Probiotic CNCM I-4034|Probiotic CNCM I-4034 in a concentration of 9x10E9 cfu (colony forming unit) per day during 28 days.
16188932|NCT01479543|Other|Probiotic CNCM I-4035|9x10E9 cfu (colony forming unit) per day during 28 days.
16188933|NCT01479543|Other|Probiotic CNCM I-4036|9x10E9 cfu (colony forming unit) per day during 28 days.
16188934|NCT01479543|Other|Probiotics CNCM I-4035 and CNCM I-4036|9x10E9 cfu (colony forming unit) per day during 28 days.
16188935|NCT01479543|Other|Placebo|Placebo capsule for 28 days.
16188936|NCT01479530|Drug|Placebo|Once daily; tablet; orally; 16 weeks
16188937|NCT01479530|Drug|Azilect®|1 mg daily; tablet; orally; 16 weeks
16188938|NCT01479517|Drug|Kovacaine Mist 0.1 mL x 4 sprays|Dose = 4 intranasal sprays of study drug delivered at 4-minute intervals.
16188939|NCT01479517|Drug|Kovacaine Mist 0.2 mL x 2 sprays|Dose = 2 intranasal sprays of study drug delivered at 4-minute intervals.
16188940|NCT01479517|Drug|Kovacaine Mist 0.2 mL x 1 spray|Dose = 1 intranasal spray of study drug
16188941|NCT01479504|Drug|nedaplatin and docetaxel|"neoadjuvant chemotherapy: nedaplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy
~concurrent chemotherapy: nedaplatin 40mg/m2,weekly,for 6 cycles during radiotherapy"
16188942|NCT01479504|Drug|cisplatin and docetaxel|"neoadjuvant chemotherapy: cisplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy
~concurrent chemotherapy: cisplatin 40mg/m2,weekly,for 6 cycles during radiotherapy"
16188943|NCT01479504|Drug|nedaplatin and docetaxel|"neoadjuvant chemotherapy: nedaplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy
~concurrent chemotherapy: nedaplatin 40mg/m2,weekly,for 6 cycles during radiotherapy"
16188944|NCT01479504|Drug|cisplatin and docetaxel|"neoadjuvant chemotherapy: cisplatin 80mg/m2+docetaxel 65 mg/m2/day,every 21 days for 2 cycles before radiotherapy
~concurrent chemotherapy: cisplatin 40mg/m2,weekly,for 6 cycles during radiotherapy"
16188945|NCT01479491|Other|Data collection|Data source will be the Japan Medical Data Centre Company Limited (JMDC) - JMDC Medical Data Bank (JMDC-MDB) database. Aggregated data (age in months and years and gender) for all subjects recorded in the database and subject-level data for IS cases will be extracted from the database. This database will be reviewed to extract data for the period between January 2005 and April 2011. Cases of IS will be identified using the International Classification of Diseases-10 (ICD-10) diagnostic codes, examination codes and procedural codes.
16188946|NCT01479478|Drug|Placebo|One placebo capsule daily.
16188947|NCT01479478|Dietary Supplement|Probiotic dietary supplement|Dietary Supplement: Lactobacillus rhamnosus GR-1, Lactobacillus reuteri RC -14
16188948|NCT01479465|Biological|Simtuzumab|SIM administered via intravenous infusion over 30 minutes
16188949|NCT01479465|Drug|Placebo to match SIM|Placebo to match SIM administered via intravenous infusion over 30 minutes
16188950|NCT01479465|Drug|Leucovorin|l-Leucovorin 200 mg/m^2 or dl-leucovorin 400 mg/m^2 administered via intravenous infusion over 2 hours
16188951|NCT01479465|Drug|Irinotecan|Irinotecan 180 mg/m^2 administered via intravenous infusion over 90 minutes
16188952|NCT01479465|Drug|Fluorouracil|Fluorouracil 400 mg/m^2 administered via intravenous bolus and 2400 mg/m^2 via intravenous infusion over 46 hours
16188953|NCT01479452|Procedure|Bariatric surgery|Gastric banding, vertical banded gastroplasty, gastric bypass
16188954|NCT01479452|Other|Usual care|Non-surgical obesity treatment
16188955|NCT01479439|Drug|Losartan|Form: suspension, tablet. Dosage & frequency: age 6-16 = 0.7mg/kg once daily; age >16 = 50mg once daily. Duration: 6 months
16188956|NCT01479426|Dietary Supplement|EFLA400|EFLA400(960mg/day)for 12 weeks
16188957|NCT01479426|Dietary Supplement|Placebo|Placebo(960mg/day) for 12 weeks
16188958|NCT01479387|Drug|[111]In-ibritumomab tiuxetan (Zevalin, BAY86-5128)|Patients who have received In-111 Zevalin.
16188959|NCT01479374|Drug|AL-4943A ophthalmic solution|
16188960|NCT01479374|Drug|AL-4943A vehicle|Inactive ingredients used as placebo
16188961|NCT01479374|Drug|Olopatadine hydrochloride ophthalmic solution, 0.2%|
16188962|NCT01479361|Drug|Atovaquone 750 mg twice daily|
16188963|NCT01479361|Drug|Atovaquone 1500 mg twice daily|
16188964|NCT01479348|Drug|[F-18]-5-FLUORO-2'-DEOXYCYTIDINE|18FdCyd radiotracer
16188965|NCT01479348|Drug|Tetrahydrouridine intravenous (IV)|Total dose of THU = 350 mg/m^2, IV
16188966|NCT01479348|Drug|Tetrahydrouridine (oral)|Total dose of THU is 3000 mg, oral
16188967|NCT01479348|Diagnostic Test|Positron emission tomography (PET)/Computed tomography (CT)|One prior CT and 3 sequential whole body PET
16188968|NCT01479296|Biological|VRC rAd5 vaccine (rAd5 gag-pol/env A/B/C)|Given intramuscularly
16188969|NCT01479296|Biological|rAd5 env A|Given intramuscularly
16188970|NCT01479296|Biological|rAd5 env B|Given intramuscularly
16188971|NCT01479296|Biological|rAd5 env C|Given intramuscularly
16188972|NCT01479296|Biological|rAd5 gag-pol|Given intramuscularly
16188973|NCT01479296|Biological|Placebo Vaccine|Given intramuscularly
16188974|NCT01479283|Drug|24-Hour Prophylactic Cefazolin* Antibiotic Regimen|"Pre-Operative Antibiotic Regimen: Patients will receive 2g (or a weight-based dose based on 100mg/kg/day with a maximum single dose of 2g if < 18 years old) of IV cefazolin within 60 minutes prior to the procedure. No other pre-operative antibiotics will be administered.
~Intra-Operative Antibiotic Regimen: Patients will receive 2g (or a weight-based dose based on 100mg/kg/day with a maximum single dose of 2g if < 18 years old) of IV cefazolin every 3-4 hours. No other intra-operative antibiotics will be administered.
~Post-Operative Antibiotic Regimen: Patients will receive 2g (or a weight-based dose based on 100mg/kg/day with a maximum single dose of 2g if < 18 years old) of IV cefazolin every 8 hours for 24 hours followed by IV saline for 4 days. No other post-operative antibiotics will be administered."
16188975|NCT01479283|Drug|5-Days Prophylactic Cefazolin* Antibiotic Regimen|"Pre-Operative Antibiotic Regimen: Patients will receive 2g (or a weight-based dose based on 100mg/kg/day with a maximum single dose of 2g if < 18 years old) of IV cefazolin within 60 minutes prior to the procedure. No other pre-operative antibiotics will be administered.
~Intra-Operative Antibiotic Regimen: Patients will receive 2g (or a weight-based dose based on 100mg/kg/day with a maximum single dose of 2g if < 18 years old) of IV cefazolin every 3-4 hours. No other intra-operative antibiotics will be administered.
~Post-Operative Antibiotic Regimen: Patients will receive 2g (or a weight-based dose based on 100mg/kg/day with a maximum single dose of 2g if < 18 years old) of IV cefazolin every 8 hours for 5 days. No other post-operative antibiotics will be administered."
16188976|NCT01479270|Drug|TAP Block|Bilateral transversus abdominal plane injection under ultrasound guidance, done at conclusion of hysterectomy procedure, prior to emergence from general anesthesia
16188977|NCT01479257|Behavioral|Questionnaires|36 questionnaires at the first visit (a total of 474 questions) and 25 questionnaires at the second visit (a total of 278 questions), taking about 60 to 90 minutes to complete each visit.
16188978|NCT01479257|Device|Accelerometer|Small device worn on the hip for 7 consecutive days that measures physical activity.
16188979|NCT01479257|Device|Smart Phone|Questions on smart phone up to 5 times a day for 7 days taking about 5-7 minutes to complete each time.
16188980|NCT01479244|Biological|NeuVax™ vaccine|E75 peptide acetate (HER2/neu p366-379) in WFI (1.5 mg/mL) mixed with 250 micrograms Leukine® (sargramostim, GM-CSF), will be administered in intradermal injections, in four divided doses (4 sites on upper thigh) once a month, for six consecutive months. At the end of the six months, NeuVax™ vaccine boosters will be given the same way once every six months for the next five times (totaling 36 months).
16188981|NCT01479244|Biological|Leukine® (sargramostim, GM-CSF) and water for injection|Leukine® 250 micrograms in water for injection, will be administered in intradermal injections, in four divided doses (4 sites on upper thigh) once a month, for six consecutive months. At the end of the six months, boosters inoculations will be given the same way once every six months for the next five times (totaling 36 months).
16188982|NCT01479231|Drug|dexlansoprazole|Dexlansoprazole 60 mg daily for 6 weeks
16188983|NCT01479218|Device|Occlutech PDA occluder|Four different sizes of Occluders will be evaluated based on pre-assessment of PDA size.
16188984|NCT01479192|Drug|Fenretinide|100mg (2cps/day) for 5 years
16188985|NCT01479192|Other|Placebo|2 cpr/day of matched placebo for 5 years
16188986|NCT01479179|Drug|AMG 479|"Phase I Starting Dose: 18 mg/kg by vein on Day 1 of a 21 day cycle.
~Phase II Starting Dose: Maximum tolerated dose from Phase I."
16188987|NCT01479179|Drug|Trastuzumab|"Phase I and II Starting Dose: 8 mg/kg by vein on Day 1 of a 21 day cycle.
~Phase I and II Maintenance Dose: 6 mg/kg by vein on Day 1 of a 21 day cycle."
16188988|NCT01479153|Procedure|Randomization of the site for catheterization|Ultra-sound guided insertion strongly recommended
16188989|NCT01479127|Drug|ABT-SLV187|
16188990|NCT01479127|Drug|Oral Levodopa/Carbidopa|Tablet; contains 100 mg levodopa and 10 mg carbidopa
16188991|NCT01479127|Device|Infusion Pump: CADD-Legacy® 1400 Pump|General infusion pump, manufactured by Smiths Medical (US)
16188992|NCT01479127|Device|NJ-Tube: Silicon ED Tube|Device used to deliver nutrition/drug to stomach/intestine or to aspirate stomach fluid, manufactured by Create Medic Co., Ltd. (Japan)
16188993|NCT01479127|Device|Adaptor: Hakko Adaptor|Accessory set for fluid infusion set, consisting of caps, connectors and adapters, etc, manufactured by Hakko Medical (Japan)
16188994|NCT01479114|Drug|rh-GCSF|10 ug/kg/day intravenously for 3 days
16188995|NCT01479101|Other|MammaPrint 70-gene expression profile|
16188996|NCT01479101|Other|BluePrint 80 gene expression profile|
16188997|NCT01479088|Drug|Cinacalcet HCl|The 6-month pre-treatment period will be followed by a run-in period with a baseline evaluation prior to the drug administration, followed by a 6-month cinacalcet dose titration period, during which the dose will be increased on monthly basis by 0.5 mg/kg or by 30 mg OD up to the achievement of target iPTH value <180 pg/mL as tolerated by the patient
16188998|NCT01479075|Drug|intransal insulin|4x 40mU intranasal insulin
16188999|NCT01479075|Drug|Placebo|
16189000|NCT01479075|Device|taVNS|
16189001|NCT01479075|Device|sham stimulation|
16189002|NCT01479062|Behavioral|Alive-PD|Weekly email/web goal-setting intervention to improve physical activity, diet and weight loss for pre-diabetics, with additional phone support
16189003|NCT01479062|Behavioral|Usual Care|Placebo Control
16189004|NCT01479049|Drug|MP (moderate potassium) group|Hearts were arrested with cold blood cardioplegia with moderate potassium concentration (K+, 10mmol/L)during cardiac operation
16189040|NCT01478776|Dietary Supplement|placebo|patient with type 2 diabetes who receive 4 cap placebo/day for 10 weeks
16189005|NCT01479049|Drug|HP (High potassium) group|Hearts are arrested with cold blood cardioplegia with high potassium concentration (K+, 20mmol/L)during cardiac operation.
16189006|NCT01479036|Drug|docetaxel and epirubicin|docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, totally 3 cycles
16189007|NCT01479036|Drug|docetaxel and epirubicin plus endostatin|docetaxel 75mg/m2, IV (in the vein) on day 1 of each 21 day cycle; epirubicin 75 mg/m2, IV (in the vein) on day 1 of each 21 day cycle; endostatin 7.5mg/m2, IV (in the vein) on 1st to 14th days of each 21 day cycle; every 3 weeks, totally 3 cycles
16189008|NCT01479023|Drug|64Cu-DOTA-U3-1287|
16189009|NCT01479023|Drug|U3-1287 (unlabeled)|
16189010|NCT01479010|Drug|Anakinra 100 mg subcutaneously daily|Anakinra 100 mg subcutaneously daily
16189011|NCT01478997|Dietary Supplement|Flexsure Capsules|Flexsure - 3 capsules once a day in the absence of meals (at least 30 min prior to meals) for 56 days
16189012|NCT01478997|Dietary Supplement|Placebo Capsules|Carboxy Methyl Cellulose
16189013|NCT01478984|Procedure|One-Stage group|Patients randomized to One-Stage group were completely revascularizated in one time PCI,
16189014|NCT01478984|Procedure|Multi-Staged group|patients randomized to Multi-Staged group were completely revascularizated in more time PCI, during the same hospitalization
16189015|NCT01478971|Drug|Epoetin|Commercially available epoetin alfa administered weekly, twice weekly, or thrice weekly at an initial starting dose, frequency of administration, and mode of administration (intravenous [IV] or subcutaneous [SC]) individually determined for each participant using the site's usual standard of care. Subsequent dose adjustments or dose holds may have been made in order to maintain a hemoglobin concentration of <11 g/dL.
16189016|NCT01478971|Drug|Peginesatide|Administered as a once monthly intravenous (IV) or subcutaneous (SC) injection. The initial dose of peginesatide injection was based on the final weekly dose of epoetin administered in the SCP; subsequent doses may have been adjusted in order to maintain hemoglobin concentrations at <11 g/dL.
16189017|NCT01478958|Dietary Supplement|SFA diet|Volunteers are following a high saturated fat diet for a 4-month period
16189018|NCT01478958|Dietary Supplement|MUFA diet|Volunteers are following a high monounsaturated fat diet for a 4-month period
16189019|NCT01478958|Dietary Supplement|n-6 PUFA diet|Volunteers are following a high n-6 polyunsaturated fat diet for a 4-month period
16189020|NCT01478945|Device|311 nm NB-UVB light|"Narrowband UVB is now the most common form of phototherapy used to treat skin diseases. Narrow-band refers to a specific wavelength of ultraviolet (UV) radiation, 311 to 312 nm. Hospital NB-UVB usually involves whole body cabinets suitable for extensive, generalised vitiligo i.e. large or multiple lesions. Usually the whole body is exposed to the UVB for a short time (seconds to minutes). NB-UVB is also used in the treatment of many other skin conditions including psoriasis and eczema.
~Hand held phototherapy units use the same lamp as the whole body units (TLO1) but only suitable for the treatment of smaller areas of skin i.e. early and focal lesions of vitiligo.
~Early reports showed that these units are also safe and effective for the treatment of psoriasis of the scalp."
16189021|NCT01478932|Behavioral|diaphragmatic breathing retraining|Experimental group participates in an 8-week breathing retraining intervention that requires 30 minutes a day. Control group receives an 8-week health promotion attention control condition.
16189022|NCT01478893|Biological|SEL-068|Sub-cutaneous injection, multiple dose
16189023|NCT01478893|Biological|Saline|Sub-cutaneous injection, multiple dose
16189024|NCT01478880|Procedure|continuous theta burst stimulation (cTBS)|bilateral continuous theta burst stimulation (bursts of 3 stimuli, 50Hz every 200ms for 40s, 80% active motor threshold) to the temporoparietal cortex (EEG 10/20: halfway T3/P3 and T4/P4)
16189025|NCT01478880|Procedure|sham cTBS|bilateral continuous theta burst stimulation (bursts of 3 stimuli, 50Hz every 200ms for 40s, 80% active motor threshold) to the temporoparietal cortex (EEG 10/20: halfway T3/P3 and T4/P4) with the stimulation coil tilted 45°
16189026|NCT01478867|Other|Detection of gluten in feces|Detection of Gluten in Feces
16189027|NCT01478854|Radiation|Radiation|Patients will be treated to a total dose of 60 Gy with a once daily fractionation schedule of 2 Gy per fraction, administered five days per week. All patients will undergo CT simulation with intravenous contrast. In addition they will undergo MRI simulation with both T1 with gadolinium as well as FLAIR sequences. They will be treated in a supine position using an aquaplast mask system for immobilization. CT image data will be reconstructed in approximately 3 mm slice thickness and manually coregistered with T1 post-gadolinium and FLAIR sequence MRI.
16189028|NCT01478854|Drug|Chemotherapy|Temozolomide
16189029|NCT01478841|Drug|polyphenol|2 capsules of 0.5 gram to be taken at the beginning of breakfast and dinner (2g/day) fructose : dose of 3 g/kg/day from D57 to D62 in the form of a 20% solution taken during the three main meals
16189030|NCT01478841|Drug|placebo|2 capsules of 0.5 gram to be taken at the beginning of breakfast and dinner (2g/day) fructose : dose of 3 g/kg/day from D57 to D62 in the form of a 20% solution taken during the three main meals
16189031|NCT01478828|Drug|Lovastatin|oral qd varying dose escalations/de-escalations
16189032|NCT01478815|Behavioral|contingency management|Participants will receive the opportunity to win prizes for submitting cocaine negative urine samples.
16189033|NCT01478815|Other|Standard Care|Standard Care
16189034|NCT01478802|Device|Lung protective CMV|Low tidal volume-high positive end-expiratory pressure conventional mechanical ventilation (CMV) and recruitment maneuvers, as specified in detail in the Detailed Description Section.
16189035|NCT01478802|Device|HFO-RMs|Initial, 96-hour-lasting session (session duration modifiable according to oxygenation criteria) of High-frequency oscillation (HFO) combined with recruitment Maneuvers (RMs), followed by additional HFO-RMs sessions (if required according to the study protocol oxygenation criteria)during days 1-10. During the rest of the intervention period, patients will be treated with the same lung protective CMV strategy of the CMV arm. Additional details are provided in the Detailed Description Section.
16189036|NCT01478789|Dietary Supplement|WD-PS intervention phase|2g/d of free plant sterol in 100g yogurt
16189037|NCT01478789|Dietary Supplement|PS-Ester intervention phase|2g/d of free plant sterol in 100g yogurt
16189038|NCT01478789|Dietary Supplement|placebo|100g/d yogurt with no added plant sterol
16189039|NCT01478776|Dietary Supplement|omega-3|4 cap 1 gr omega-3 per day for 10 weeks
16189278|NCT01477034|Dietary Supplement|Vitamin D3|2,000 or 4,000 IU/day vitamin D3 for 3 or 6 months.
16189041|NCT01478750|Dietary Supplement|administration of fat (sunflower oil), emulsified|40 ml sunflower oil, in the presence of the emulsifier tween-80.
16189042|NCT01478750|Procedure|Insertion of nasoduodenal tube|A nasoduodenal tube is inserted to enable collection of gastric and duodenal aspirates of 2 mL each, to determine gastrointestinal digestion of fat
16189043|NCT01478737|Drug|Intravitreal dexamethasone implant|Intravitreal Ozurdex after vitrectomy
16189044|NCT01478737|Procedure|Vitrectomy|Vitrectomy only
16189045|NCT01478724|Dietary Supplement|Milk proteins fraction|capsules, one per day, 24 months
16189046|NCT01478711|Other|Clinical Decision Support Tool|A clinical decision support tool embedded within Epic will appear for children with a history of prematurity at the intervention sites.
16189047|NCT01478698|Drug|Tissue Plasminogen Activator (tPA)|tPA 10mg per dose intraperitoneal
16189048|NCT01478698|Drug|recombinant deoxyribonuclease (DNase)|DNase 5mg per dose given intraperitoneally.
16189049|NCT01478685|Drug|CC-486|CC-486 will be administered orally at doses between 100-300 mg daily for either 14 or 21 days depending on tolerability
16189050|NCT01478685|Drug|Carboplatin|Carboplatin will be given by intravenous (IV) infusion once every 21 Days at a dosage of AUC x 4.
16189051|NCT01478685|Drug|ABI-007|ABI-007 will be administered by intravenous (IV) infusion on two of every three weeks at a dosage of 100 mg/m^2
16189052|NCT01478672|Procedure|Health Coaching and Life-long Monitoring|Participants receive tablet PCs with software that collects and transmit diagnostic measurements. Measurements are performed by the participants following indications of the health coaching team. Equipment used by all participants: • blood pressure meter, • pedometer • pulse watch• 2-channel electrocardiograph. Measured values are entered manually by the participants, unrealistic values are refused and values are provided with a time-stamp. Measurements is reviewed in a graphical display. Measured values are accessed by the health coaching team that develops an individualized measurement and medication scheme. Reminders are provided by the software and can be exported to personal calendars or mobile phones. Secure authentication of users is be provided
16189053|NCT01478659|Dietary Supplement|Control study food with no added fiber|Adults consuming their usual diet modified by incorporating yogurt and snack bars without added fiber.
16189054|NCT01478659|Dietary Supplement|Study food with added fiber|Adults consuming their usual diet modified by incorporating yogurt and snack bars containing 16 g of chicory root fiber (Frutalose®).
16189055|NCT01478646|Other|conventional breathing therapy|duration: 60 minutes.
16189056|NCT01478646|Other|reflectory breathing therapy|duration: 60 minutes.
16189057|NCT01478633|Drug|Galantamine|8 mg/day (4 mg twice daily) for 4 weeks, followed by 16 mg/day (8 mg twice daily) for an additional 4 weeks, followed by dose at 16 mg or increased to 24 mg (with the option of decreasing back to 16 mg) for the remainder of the study (to week 24)
16189058|NCT01478620|Drug|Canephron® N|3x 2 coated tablets/day for 7 days p.o.
16189059|NCT01478607|Drug|QUTENZA|A Qutenza (8% capsaicin) patch will be applied to identified painful areas for 30 minutes (Arm 1) or 60 minutes (Arm 2).
16189060|NCT01478594|Drug|Tivozanib|Capsules for oral administration
16189061|NCT01478594|Drug|Bevacizumab|Solution for intravenous infusion
16189062|NCT01478594|Drug|mFOLFOX6|mFOLFOX6 regimen is a combination therapy of oxaliplatin 85 mg/m^2 administered as an intravenous bolus over 2 hours on Days 1 and 15, leucovorin calcium 400 mg/m^2 administered as an intravenous bolus over 2 hours on Days 1 and 15, fluorouracil 400 mg/m^2 administered as an intravenous bolus over 5 to 15 minutes on Days 1 and 15, then 2400 mg/m^2 continuous intravenous infusion over 46 hours on Days 1 to 3 and 15 to 17.
16189063|NCT01478581|Drug|PCI-32765|
16189064|NCT01478581|Drug|Dexamethasone|
16189065|NCT01478568|Drug|mirabegron|oral
16189066|NCT01478568|Drug|desipramine|oral
16189067|NCT01478555|Drug|ISV 101|Bromfenac in DuraSite
16189068|NCT01478542|Drug|Conventional Vincristine|
16189069|NCT01478542|Drug|Liposomal Vincristine|
16189070|NCT01478542|Drug|Ricover-scheme rituximab|
16189071|NCT01478542|Drug|optimised rituximab-schedule|
16189072|NCT01478529|Drug|mirabegron OCAS|oral administration
16189073|NCT01478529|Drug|mirabegron|iv administration
16189074|NCT01478516|Procedure|Intravitreal injection|autologous plasmin was prepared in the operation department. Samples (3.5 mL) of autologous whole blood, collected by sterile vacuum blood collection tubes, were obtained from a peripheral vein. The blood was centrifuged at 4,000 rounds per minute for 15 minutes to obtain complete sedimentation of the cells; 1.5 mL of the plasma was aspirated and transferred under sterile conditions in a vial of urokinase(10,000 IU) that had been incubated for 15 minutes at 37°C. By gently moving the vial for 5 minutes, the solution was incubated for 15 minutes at 37°C; 0.2 mL of the obtained solution was used for intravitreal injection.
16189075|NCT01478503|Drug|mirabegron OCAS|oral
16189076|NCT01478503|Drug|Placebo|oral
16189077|NCT01478490|Drug|mirabegron|oral
16189078|NCT01478490|Drug|metoprolol|oral
16189079|NCT01478477|Dietary Supplement|omega-3 fatty acid supplement|6 capsules per day (4.3 g)x 6 months
16189080|NCT01478477|Other|Placebo|6 capsules per day (4.3 g)x 6 months. Supplement should be taken with food once per day. No specific food requirements are needed.
16189081|NCT01478477|Other|Clinical assessments|All three instruments will be administered at baseline, at 3 months, 6 months and at additional time intervals when there is a significant change in therapy (discontinuation/switch, pain medication administration) during routine medical oncology visits.
16189082|NCT01478477|Other|Assessment of therapy complications|Severity/grade of reaction according to the NCI Common Terminology Criteria for Adverse Events v4.0 (CTCAE).
16189083|NCT01478477|Procedure|Magnetic Resonance Imaging|Optional bilateral hand and wrist MRI imaging will be obtained at baseline and at 6 months to eligible patients who have no contraindications to MRI imaging.
16189084|NCT01478477|Procedure|Correlative/special studies|Plasma, RBC, and serum samples from the baseline blood draw will also be stored at -70C for fatty acid and biomarker analyses and repeated at 3 month and 6 month intervals. Samples will be analyzed in batches every 6 months.
16189085|NCT01478464|Other|Massage|"The hamstring muscle will be massaged with a massage roller for ten minutes."
16189086|NCT01478451|Behavioral|Exercise|Exercise will be performed for 10 minutes at the left or right trapezius (randomized)
16189087|NCT01478451|Other|Massage|massage will be provided for 10 minutes at the left or right trapezius (randomized)
16189088|NCT01478438|Device|Novilase Interstitial Laser Therapy|Image guided Interstitial Laser Ablation of breast tumors
16189089|NCT01478425|Device|Lipidic Microemulsion|Topical nasal, twice a day
16189090|NCT01478425|Device|Saline|Topical Nasal, twice a day
16189091|NCT01478412|Other|Polymer based fiducial placement|Fiducial marker placement with rectal ultrasound imaging.
16189092|NCT01478399|Drug|PB1023 Injection|90 mg Dose
16189093|NCT01478386|Other|Orthovisc|Subjects will receive a series of three Orthovisc injections into their affected knee
16189094|NCT01478386|Device|DonJoy HA lite knee brace|Subjects will be fitted and educated on using the DonJoy HA lite knee brace to treat their affected knee
16189095|NCT01478386|Device|Orthovisc injections and DonJoy HA lite knee brace|Subjects will receive a series of three Orthovisc injections and be fitted and educated on using a DonJoy HA lite knee brace
16189096|NCT01478373|Drug|Dovitinib (TKI258)|Oral Dovitinib (TKI258) as a gelatin capsule of 100 mg strength and dosed on a flat scale of 500 mg on a 5 days on /2 days off dosing schedule.
16189097|NCT01478360|Drug|AIN457 (secukinumab)|Secukinumab intravenous injection
16189098|NCT01478360|Drug|Placebo|Placebo intravenous injection
16189099|NCT01478347|Biological|Recombinant meningococcal B + OMV NZ|2 injections 2 months apart
16189100|NCT01478334|Behavioral|high intensity interval training|"First 10 week of high intensity interval training, twice a week. The interval training session consists of 10 minutes warm up at 70 percent of maximal heart rate and continues with 4 times 4 minutes of high intensity intervals at 90 to 95 percent of maximal heart rate separated by 3 minutes of active brakes in between at 70 percent of maximal heart rate. Training will be performed by cycling. Training intensity will be supervised through the use of polar puls monitors and the BORG scale of subjective perceived exhaustion.
~Second 10 weeks participants are instructed not to change their dietary patterns or physical activity levels during the study period."
16189101|NCT01478334|Behavioral|Control|"First 10 weeks participants are instructed not to change their dietary patterns or physical activity levels, and to continue their habitually lifestyle.
~Second 10 week of high intensity interval training, twice a week. The interval training session consists of 10 minutes warm up at 70 percent of maximal heart rate and continues with 4 times 4 minutes of high intensity intervals at 90 to 95 percent of maximal heart rate separated by 3 minutes of active brakes in between at 70 percent of maximal heart rate. Training will be performed by cycling. Training intensity will be supervised through the use of polar puls monitors and the BORG scale of subjective perceived exhaustion."
16189102|NCT01478321|Drug|Temozolomide|Given PO
16189103|NCT01478321|Radiation|hypofractionated radiation therapy|Undergo hypofractionated radiation therapy
16189104|NCT01478321|Biological|bevacizumab|Given IV
16189105|NCT01478321|Other|questionnaire administration|Ancillary studies
16189106|NCT01478308|Drug|Metformin hydrochloride|Metformin is administered orally, with food. Metformin tablets contain 500mg, 850mg, or 1000mg of metformin hydrochloride. Tablets contain inactive ingredients including pofidone and magnesium stearate. The coating for 500mg and 850mg tablets contains hypromellose. Metformin is an antihyperglycemic agent which decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization.In this study, Metformin will be given 850 mg orally, with food, once daily for 1 week starting the week before first docetaxel infusion, and thereafter 850 mg twice daily.
16189107|NCT01478308|Drug|Docetaxel|Docetaxel will be administered 75 mg/m2 as one hour infusion on day 1 every 21 days.
16189108|NCT01478308|Drug|Prednisone|Prednisone will be given 5mg orally twice daily which is the standard regimen with docetaxel
16189109|NCT01478295|Behavioral|CuidaCare Intervention|Nursing intervention address to Caregiver Standardized care plan (PCE) Coping strategies promoting social support and empowerment through health education
16189110|NCT01478295|Other|Control Group/Usual Care:|"Control Group/Usual Care:
~Standardized care plan (PCE) Coping strategies promoting social support and empowerment through health education"
16189111|NCT01478282|Drug|Rivaroxaban|20 mg/day, oral administration maintained for 5 days
16189112|NCT01478282|Drug|Dabigatran|150 mg/12 hours, administered orally, treatment maintained for 5 days
16189113|NCT01478256|Drug|Erythromycin|Topical erythromycin ointment twice a day
16189114|NCT01478256|Drug|Besifloxocin|Topical Besifloxocin twice a day
16189115|NCT01478230|Drug|Nicotine|Nicotine 5 mg Inhaler
16189116|NCT01478230|Drug|Nicotine|Nicotine 10 mg Inhaler
16189117|NCT01478178|Drug|VAL-083 (Dianhydrogalactitol)|VAL-083 given by intravenous infusion with a starting dose of 1.5 mg/m2 IV. Escalating doses to be administered in sequential dose cohorts.
16189118|NCT01478165|Drug|Total intravenous anesthesia|Total intravenous anesthesia plus normal saline 1.5 ml immediately before induction of anesthesia
16189119|NCT01478165|Drug|Total intravenous anesthesia plus palonosetron|Total intravenous anesthesia plus palonosetron 0.075 mg(1.5 ml)immediately before induction of anesthesia
16189120|NCT01478152|Other|Drug-like Medical Device: Ectoin Inhalation Solution|"After baseline visit subjects will receive 0.9% saline inhalation solution for placebo. Patients will be instructed to inhale once daily with the AKITA2® APIXNEB® inhalation system for 5 - 7 days.
~The treatment phase with low dose of Ectoin® will follow subsequently without any washout phase. This treatment phase will be repeated for medium and a high Ectoin® dose. All doses of Ectoin® inhalation solution will be administered for 5 - 7 days without any washout phase. To minimize circadian variations Methacholine challenge tests will be performed always at the approximately same time. Sputum inductions will be conducted on the last but one day of placebo treatment phase and on the last but one day of treatment phase with the highest Ectoin® dose."
16189121|NCT01478139|Procedure|LIFT-plug|Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track and plug (LIFT-plug) procedure
16189122|NCT01478139|Procedure|LIFT|Subjects randomized to this arm will receive the ligation of the intersphincteric fistula track (LIFT) procedure
16189123|NCT01478126|Drug|N(2)-L-Alanine L-Glutamine dipeptide|Intravenous infusion of glutamine in total dose of 2 g/kg/day (rate=2*weight/24 ml/h). Infusion starts in operating room and ends next day after the surgery.
16189124|NCT01478126|Drug|Placebo|Intravenous infusion of 0,9% solution of NaCl, rate=2*weight/24. Infusion starts in operating room and ends next day after the surgery.
16189125|NCT01478113|Drug|Amphetamine/dextroamphetamine|The amphetamine/dextroamphetamine will be in a pill formulation. The dosage of the amphetamine/dextroamphetamine will be flexibly adjusted up or down by a study clinician based on the participant's response. Dose ranges will be 1-3 pills (placebo or 5 mg amphetamine) in the morning and 1-3 pills (placebo or 5 mg amphetamine) at noon.
16189126|NCT01478113|Drug|Placebo|The placebo will match the dextroamphetamine in form, dosage, frequency, and duration.
16189127|NCT01478113|Behavioral|Well-being therapy|Therapy sessions will last between 30-50 minutes. The sessions will take place at every visit after the screening visit.
16189128|NCT01478087|Device|Mysorba|Subjects will undergo one cycle of five immunoadsorption (IA) treatment sessions over two weeks.
16189129|NCT01478074|Drug|G-CSF|5 mcg/kg daily from day -7 until post-nadir ANC > 1000
16189130|NCT01478074|Drug|Cytarabine|2 g/m2 daily from day -6 through -2
16189131|NCT01478074|Drug|Fludarabine|30 mg/m2 daily from day -6 through -2
16189132|NCT01478074|Biological|Donor Natural Killer (NK) cells|Infused once on day 0. Four cohorts of escalating doses receiving 0, 1, 10, or 20 x 10^6 cells/Kg
16189133|NCT01478074|Biological|ALT-801|0.04 mg/kg IV thrice weekly for 8 doses beginning day +2
16189134|NCT01478061|Device|Anastomosis (C-Port® )|creation of anastomoses in blood vessels and grafts, including use in coronary artery bypass grafting procedures
16189135|NCT01478048|Biological|Elotuzumab|Solution; Intravenous (IV); 10 mg/kg; (Cycles 1 & 2: Days 1, 8 & 15; Cycles 3-8: Days 1 & 11; Cycle 9+: Days 1 & 15); Until subject meets criteria for discontinuation of study drug
16189136|NCT01478048|Drug|Bortezomib|Solution; IV; 1.3 mg/m2; (Cycles 1 - 8: Days 1, 4, 8, 11; Cycles 9+: Days 1, 8, 15); Until subject meets criteria for discontinuation of study drug
16189137|NCT01478048|Drug|Dexamethasone|Tablets; Oral; 20 mg; (Cycles 1& 2: once daily on Days 2, 4, 5, 8, 9, 11; Cycles 3-8: once daily on Days 2, 4, 5, 9, 12; Cycles 9+: once daily on Days 2, 8, 9, 16); Until subject meets criteria for discontinuation of study drug
16189138|NCT01478048|Drug|Dexamethasone|Tablets; Oral; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until subject meets criteria for discontinuation of study drug
16189139|NCT01478048|Drug|Dexamethasone|Solution; IV; 8 mg; (Cycles 1& 2: Days 1, 8, 15; Cycles 3-8: Days 1 &11; Cycles 9+; Days 1 & 15); Until subject meets criteria for discontinuation of study drug
16189140|NCT01478048|Drug|Dexamethasone|Tablets; Oral; 20 mg; (Cycles 1-8 once daily on Days 1, 2, 4, 5, 8, 9, 11, 12; Cycles 9+ once daily on Days 1, 2, 8, 9, 15, 16); Until subject meets criteria for discontinuation of study drug
16189141|NCT01478035|Drug|Phenytoin|Phenytoin 18 mg /Kg/day iv as loading dose. 24 hours later phenytoin 6 mg/Kg/d in 3 divided doses iv shifting to oral route at the same dose when the patient is able to use oral route.
16189142|NCT01478035|Drug|placebo|Placebo 18 mg /Kg/day iv as loading dose. 24 hours later placebo 6 mg/Kg/d in 3 divided doses iv shifting to oral route at the same dose when the patient is able to use oral route.
16189143|NCT01478022|Drug|Isosorbide Dinitrate|Isosorbide Dinitrate 10 mgx2, daily, capsules
16189144|NCT01478022|Drug|Ibuprofen|Ibuprofen 200 mg daily, capsules
16189145|NCT01478022|Other|Ibuprofen and Isosorbide Dinitrate combination|Ibuprofen 200 mg and Isosorbide Dinitrate 20 mg combination daily dose
16189146|NCT01478009|Dietary Supplement|Korean red ginseng|Korean red ginseng(3.0g/day) for 12 weeks
16189147|NCT01478009|Dietary Supplement|Placebo|Placebo (3.0g/day) for 12 weeks
16189148|NCT01477996|Procedure|27-gauge|27-gauge needle for IVT
16189149|NCT01477996|Procedure|30-gauge|30-gauge needle for IVT
16189150|NCT01477983|Procedure|ATP guide additional ablation.|Following successful PV isolation, intravenous ATP of 0.4 mg/body-weight-kg is rapidly is injected, and dormant LA-PV conduction is evaluated. If dormant LA-PV conduction is unmasked, then additional radiofrequency energy applications are delivered to the conduction gaps until disappearance of dormant LA-PV conduction.
16189151|NCT01477983|Drug|Antiarrhythmic drug (AAD)|Following successful ablation, AAD (Vaughan Williams class I or III) is administered for 90 days. The recommended drugs are flecainide, propafenone, sotalol and amiodarone, but the final choice of drug and dosage is left to the discretion of the attending physician.
16189152|NCT01477983|Procedure|ATP guide additional ablation.|Following successful PV isolation, intravenous ATP of 0.4 mg/body-weight-kg is rapidly is injected, and dormant LA-PV conduction is evaluated. If dormant LA-PV conduction is unmasked, then additional radiofrequency energy applications are delivered to the conduction gaps until disappearance of dormant LA-PV conduction.
16189153|NCT01477983|Drug|Control|Following successful ablation, AAD (Vaughan Williams class I or III) including flecainide, propafenone, sotalol and amiodarone is not used during the period of 0 - 90 days.
16189154|NCT01477983|Procedure|Control|Following successful PV isolation, intravenous ATP is not administered.
16189155|NCT01477983|Drug|Antiarrhythmic drug (AAD)|Following successful ablation, AAD (Vaughan Williams class I or III) is administered for 90 days. The recommended drugs are flecainide, propafenone, sotalol and amiodarone, but the final choice of drug and dosage is left to the discretion of the attending physician.
16189156|NCT01477983|Procedure|Control|Following successful PV isolation, intravenous ATP is not administered.
16189157|NCT01477983|Drug|Control|Following successful ablation, AAD (Vaughan Williams class I or III) including flecainide, propafenone, sotalol and amiodarone is not used during the period of 0 - 90 days.
16189158|NCT01477957|Procedure|surgery|biliopancreatic diversion, gastric banding, gastric sleeve resection
16189159|NCT01477931|Drug|Bupropion extended release|300mg once a daily, PO, 8weeks
16189160|NCT01477905|Device|Remi50 with prime|for using experimental TCIs, targeting an effect-site concentration (Ceff) of 4.0 ng/ml, was performed using 50 μg/ml (Remi50) of remifentanil, with PRIMING
16189161|NCT01477905|Device|Remi20 with prime|For using experimental TCIs, targeting an effect-site concentration (Ceff) of 4.0 ng/ml, was 20 μg/ml (Remi20) of remifentanil, and with PRIMING
16189162|NCT01477892|Drug|low dose remifentanil|non-inferiority test for low dose remifentanil 0.1mcg/kg/min compared with high dose remifentanil 0.25mcg/kg/min in pain control
16189163|NCT01477879|Other|Versabase gel with sarracenia purpurea 20% liquid extract|Topical application of gel/plant mix to lesions
16189164|NCT01477879|Other|placebo (versabase gel only)|versabase gel only
16189269|NCT01477112|Dietary Supplement|Betacarotene|6 mg betacarotene in caplets for 45 days (daily)and reevaluate parameters 30 days after finishing supplementation
16189165|NCT01477866|Dietary Supplement|citogenex|CITOGENEX is a dietary supplement of insoluble polysaccharides, of Lactobacillus Casei (specific type) and of Bifidobacterium Lactis (specific type).
16189166|NCT01477866|Other|conventional therapy|conventional therapy for colon-rectal cancer
16189167|NCT01477853|Drug|Sitagliptin|Sitagliptin 100 mg tablet orally daily
16189168|NCT01477853|Drug|Atorvastatin|Atorvastatin 80 mg tablet orally daily
16189169|NCT01477853|Other|Placebo to sitagliptin|Placebo to sitagliptin tablet orally daily
16189170|NCT01477853|Other|Placebo to atorvastatin|Placebo to atorvastatin tablet orally daily.
16189171|NCT01477853|Drug|Metformin (open-label)|Participant will remain on prestudy dose of metformin tablets (at least 1500 mg daily) throughout entire study.
16189172|NCT01477853|Drug|Glimepiride (open-label)|Phase A: Glimepiride 1 or 2 mg tablet once daily with breakfast or the first main meal of the day (titrated up to 6 mg/day) for 16 weeks as rescue therapy for randomized participants not meeting specific glycemic goals.
16189173|NCT01477853|Drug|Glimepiride (double-blind)|Phase B: glimepiride up to 6 mg daily for participants not rescued with open-label glimepiride during Phase A.
16189174|NCT01477853|Drug|Placebo to glimepiride|Phase B: placebo to glimepiride tablet orally daily.
16189175|NCT01477840|Drug|Misoprostol|Sublingual Misoprostol 200 Micrograms After Spinal Anesthesia
16189176|NCT01477827|Other|None - observational study|
16189177|NCT01477814|Behavioral|Physician chart reminder|Subjects randomized to this intervention will have paper or electronic chart reminders placed on their medical records alerting their physicians to the need for colorectal cancer screening
16189178|NCT01477814|Behavioral|chart reminder, educational mat'ls, FIT|Subjects randomized to this group will have a physician chart reminder, mailed educational packet which includes the CDC Screen for Life materials, a FIT with return envelope, a magnet to remind the subject about CRC screening and a CRC screening preference sheet
16189179|NCT01477814|Behavioral|CR,ed mat'ls, FIT, phone call|Subjects randomized to this group will have a physician chart reminder, mailed educational packet which includes the CDC Screen for Life materials, a FIT with return envelope, a magnet to remind the subject about CRC screening and a CRC screening preference sheet. Subjects will also receive a telephone call from project staff to assess barriers to screening and to encourage CRC screening
16189180|NCT01477801|Drug|CHOLECALCIFEROL|"Standard guideline based therapy plus cholecalciferol:
~Loading dose 300.000 U then 50.000 U every month for six months"
16189181|NCT01477801|Drug|PLACEBO|Standard guideline based therapy plus placebo
16189182|NCT01477775|Drug|Oral P2Y12 receptor blocker|Free choice among clopidogrel, prasugrel or ticagrelor
16189183|NCT01477775|Drug|Customized choice for the oral P2Y12 receptor blocker|one drug among clopidogrel, prasugrel or ticagrelor based on an algorithm integrating phenotype information.
16189184|NCT01477762|Drug|Dexamethasone|One tablet of 0.5 mg dexamethasone will be taken ten hours prior to completing study assessments.
16189185|NCT01477762|Drug|Placebo|One placebo tablet will be taken ten hours prior to completing study assessments.
16189186|NCT01477749|Biological|sipuleucel-T|Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
16189187|NCT01477736|Drug|Oxybutynin|5 mg of immediate-release oxybutynin orally 3 times daily
16189188|NCT01477736|Drug|Botulinum toxin A|300 U intradetrusor injection
16189189|NCT01477723|Other|Experimental Oral Nutritional Supplement|Experimental ONS orally Two 8 fl oz servings/day
16189190|NCT01477710|Procedure|Hold mask|The clinician will connect a SAVe ventilator to a face mask and hold the mask in place on the mannequin with two hands while maintaining the airway on the correct position for 10 minutes.
16189191|NCT01477710|Procedure|Strap Mask|The clinician will attach the face mask to the mannequin using the mask and mask strap included in the ventilator kit for 10 minutes
16189192|NCT01477710|Procedure|Airway|The clinician will blindly insert a supralaryngeal airway (the King lT) and connect the SAVe ventilator to the connector and provide ventilation for 10 minutes.
16189193|NCT01477697|Dietary Supplement|Omega-3|50 mg/kg per day of omega-3 fatty acids
16189194|NCT01477697|Dietary Supplement|Placebo|50 mg/kg per day of placebo equivalent
16189195|NCT01477632|Drug|0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)|A single oral dose of 2 tablets under fasting conditions
16189196|NCT01477632|Drug|0.5 mg estradiol / 0.25 mg norethisterone acetate (NETA)|A single oral dose of 2 tablets under fasting conditions
16189197|NCT01477632|Drug|1.0 mg estradiol / 0.5 mg norethisterone acetate (NETA)|A single oral dose of 1 tablet under fasting conditions
16189198|NCT01477619|Drug|Tasimelteon|20mg single dose on Day 1
16189199|NCT01477606|Drug|Midostaurin|"Induction therapy: 50 mg, oral, twice daily, starting on day 8, thereafter continuous dosing until 48h before start of subsequent chemotherapy cycle.
~Consolidation therapy: 50 mg, oral twice daily, starting on day 6, thereafter continuous dosing until 48h before start of conditioning therapy for allogeneic HSCT or 48h before start of subsequent consolidation chemotherapy.
~Maintenance therapy:
~50 mg oral twice daily over one year."
16189200|NCT01477606|Drug|Cytarabine|"Induction therapy:
~200 mg/m2/day by continuous i.v. infusion on days 1-7 (total dose 1400 mg/m²)
~Consolidation therapy:
~Younger adult patients (18 to 65 yrs): 3 g/m2 by i.v infusion over 3 hours every 12 hours on days 1, 3, and 5 (total dose 18 g/m2).
~Older patients (>65 yrs): 1 g/m2 by i.v. infusion over 3 hours every 12 hours on days 1, 3, and 5 (total dose 6 g/m2)."
16189201|NCT01477606|Drug|Daunorubicin|"Induction therapy:
~60 mg/m², by 1-hour i.v. infusion, day 1-3 (total dose 180 mg/m²)"
16189202|NCT01477593|Procedure|circumcision with Shenghuan in Yan's method|The foreskin is first separated from the glans.Then the inner ring is placed between them and over the glans. After adjusting the position of inner ring to retain 0.5cm inner foreskin, the operator install the outer ring over the foreskin and combine them together. Removal of excess foreskin is then performed upon the device.
16189270|NCT01477112|Dietary Supplement|Controls. No treatment|Evaluate at time 0, 45 days and 75 days, but without receiving betacarotene supplements
16189271|NCT01477099|Device|Toothbrushing with a manual brush|Toothbrushing with a manual brush
16189272|NCT01477073|Drug|FSH-GEX™|
16189273|NCT01477073|Drug|recombinant FSH|
16189274|NCT01477073|Drug|urinary FSH|
16189275|NCT01477073|Drug|Placebo|
16189203|NCT01477593|Procedure|circumcision with Shenghuan in Peng's method|The foreskin is first separated from the glans. Then the inner ring is placed on the outer layer of foreskin. Next, the rim of the foreskin is clamped with blood vessel forceps at the 3, 6, 9 and 12 o'clock points. An urologist and an assistant each hold two clamps to widen the opening of the foreskin, and pull it over the inner ring. After the inner and outer layers of the foreskin and the frenulum are symmetrically positioned, the assistant install the outer ring over the foreskin and gently combine it together. Removal of excess foreskin is then performed below the device.
16189204|NCT01477593|Procedure|conventional method with incision|The procedure of conventional circumcision involve transection of the excess foreskin with reservation of 0.5cm inner foreskin, haemostasis by electrocautery and suture of skin edges with 4-0 absorption sutures.
16189205|NCT01477580|Biological|Low-dose V180 with low-dose ISCOMATRIX™ adjuvant|Three 0.5-mL intramuscular doses of low-dose V180 containing low-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
16189206|NCT01477580|Biological|Low-dose V180 with medium-dose ISCOMATRIX™ adjuvant|Three 0.5-mL intramuscular doses of low-dose V180 containing medium-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
16189207|NCT01477580|Biological|Medium-dose V180 (non-adjuvanted)|Three 0.5-mL intramuscular doses of medium-dose V180 with no adjuvant at Months 0, 1, and 2
16189208|NCT01477580|Biological|Medium-dose V180 with low-dose ISCOMATRIX™ adjuvant|Three 0.5-mL intramuscular doses of medium-dose V180 containing low-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
16189209|NCT01477580|Biological|Medium-dose V180 with medium-dose ISCOMATRIX™ adjuvant|Three 0.5-mL intramuscular doses of medium-dose V180 containing medium-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
16189210|NCT01477580|Biological|Medium-dose V180 with Alhydrogel™ adjuvant|Three 0.5-mL intramuscular doses of medium-dose V180 containing Alhydrogel™ adjuvant at Months 0, 1, and 2
16189211|NCT01477580|Biological|High-dose V180 (non-adjuvanted)|Three 0.5-mL intramuscular doses of high-dose V180 with no adjuvant at Months 0, 1, and 2
16189212|NCT01477580|Biological|High-dose V180 with low-dose ISCOMATRIX™ adjuvant|Three 0.5-mL intramuscular doses of high-dose V180 containing low-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
16189213|NCT01477580|Biological|High-dose V180 with medium-dose ISCOMATRIX™ adjuvant|Three 0.5-mL intramuscular doses of high-dose V180 containing medium-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
16189214|NCT01477580|Biological|Low-dose V180 with high-dose ISCOMATRIX™ adjuvant|Three 0.5-mL intramuscular doses of low-dose V180 containing high-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
16189215|NCT01477580|Biological|Medium-dose V180 with high-dose ISCOMATRIX™ adjuvant|Three 0.5-mL intramuscular doses of medium-dose V180 containing high-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
16189216|NCT01477580|Biological|High-dose V180 with high-dose ISCOMATRIX™ adjuvant|Three 0.5-mL intramuscular doses of high-dose V180 containing high-dose ISCOMATRIX™ adjuvant at Months 0, 1, and 2
16189217|NCT01477580|Biological|Placebo|Three 0.5-mL intramuscular doses of phosphate-buffered saline at Months 0, 1, and 2
16189218|NCT01477567|Drug|LY3009385|
16189219|NCT01477567|Drug|Placebo|
16189220|NCT01477554|Other|PRONTO training|PRONTO is an intervention consisting of two training modules for medical professionals. Module 1 is delivered over 2-3 days, takes place in the hospital, and consists of high-fidelity, low-tech simulations. The curriculum employs elements of the Team STEPPS program to strengthen teamwork and leadership skills, and the use of effective communication techniques. The activities and simulations have clear objectives and use evidenced-based medical concepts. Module 2, the follow-up training, uses the same teaching methodology as Module 1 to reinforce teamwork, communication, and emergency response skills, and incorporates new topics such as preeclampsia /eclampsia, shoulder dystocia and pelvic presentation.
16189221|NCT01477541|Other|PM/ON integration|Professional midwives or obstetric nurses are integrated into clinic staff and delivering services.
16189222|NCT01477502|Other|individual homeopathic treatment|participants are diagnosed by a trained homeopath and receive individualized homeopathic treatment in addition to standard UTI prophylaxis
16189223|NCT01477502|Other|standard treatment without homeopathy|participants receive standard UTI prophylaxis
16189224|NCT01477489|Drug|Veliparib|Starting dose of veliparib will be 50 mg taken twice daily and will escalate up to a possible 200 mg twice daily.
16189225|NCT01477489|Radiation|Standard radiation treatment|Limited to 60 Gy.
16189226|NCT01477476|Drug|Anakinra|Anakinra treatment will be given I.V. as a bolus of 2 mg/kg infused intravenously over 30 minutes followed by infusion of 2 mg/kg/hour for 4 hours.
16189227|NCT01477476|Other|Placebo Comparator|A placebo will be given to 7 subjects.
16189228|NCT01477463|Drug|Vitamin D3|4,000 IU oral vitamin D3
16189229|NCT01477463|Drug|placebo and vitamin D|
16189230|NCT01477450|Device|Pulse-dose oxygen|Pulsed-dose oxygen delivery from an oxygen concentrator
16189231|NCT01477450|Device|Cylinder oxygen delivery|Oxygen delivery from an oxygen cylinder
16189232|NCT01477437|Other|Teens Taking Charge: Managing Hemophilia Online- Online self-management intervention|"The content will be delivered on a password-protected website, as part of the About Kids Health interface developed and maintained at the Hospital for Sick Children, Toronto, Canada. The website has been developed as eight discrete educational modules for adolescents. Each module takes approximately 30 to 45 minutes to complete. Content has been written and reviewed by experts from comprehensive hemophilia care clinics across Canada (physicians, nurses, physiotherapists and social workers) and edited by a medical writer to ensure that it is written at the suggested grade 6 reading level for patient education materials. Content has been written in English and will be translated into French prior to program launch. The format is geared towards adolescents and includes narratives with video components and interactive illustrations. In addition, each module will have quiz questions with real-time feedback to promote interactivity and knowledge retention."
16189233|NCT01477424|Drug|PA21|The maximum dose of PA21 will be 15.0 g/day.
16189234|NCT01477424|Drug|Warfarin|The maximum dosage of Warfarin will be 10 mg/day
16189235|NCT01477411|Drug|PA21|The maximum dose of PA21 will be 15.0 g/day.
16189236|NCT01477411|Drug|Digoxin|The maximum dosage of Digoxin will be 0.5 mg/day
16189237|NCT01477398|Device|QED-100|Use of the QED-100 results in mild hypercapnia during emergence
16189276|NCT01477060|Drug|Lapatinib|1250 mg/ die, os
16189277|NCT01477060|Drug|Metformin|1500 mg/die, os
16189238|NCT01477385|Procedure|Resin Infiltration|After cleaning the proximal surface with caries lesion, it will be performed the local infiltration anesthesia and adaptation of the rubber dam. The adjacent tooth will be protected by plastic or metal strip. Hydrochloric acid 15% will be applied on the lesion, which will be washed and dried. The surface should be dried by applying 95% ethanol and air-way syringe. The resin infiltration (Icon, DMG) will be applied on the lesion. The resin will be polymerized and applied again and polymerized.
16189239|NCT01477385|Procedure|30% Silver Diammine Fluoride|It will be cleaned like group I. Soft tissues will be protected with petroleum jelly. The 30% silver diamine fluoride (Cariestop, Biodinamica) will be applied with a disposable microbrush for 3m. Then the surface will be washed for 30s.
16189240|NCT01477385|Procedure|Dental Flossing|In this group, the patient will perform only mechanical removal of biofilm to floss daily.
16189241|NCT01477385|Procedure|Resin Infiltration Placebo|In this group, the patient will be held only inserting the rubber dam and applied sterile water as a substitute for acid, ethanol and resin infiltration.
16189242|NCT01477385|Procedure|30% Silver Diammine Fluoride Placebo|Soft tissues will be protected with petroleum jelly. The patient will receive sterile water application with a disposable microbrush for 3m. Then the surface will be washed for 30s.
16189243|NCT01477372|Behavioral|Supervised exercise program|Intervention group participated in Blooming Exercise Program as from week 10-12 of gestation. At least 56 sessions through 22 weeks. 3 sessions per week
16189244|NCT01477346|Other|Nurse intervention|Complex package of care involving patient information and advice concerning lifestyle modification and recommended drug therapy.
16189245|NCT01477346|Other|Standard care|Continuing standard General Practitioner led care.
16189246|NCT01477333|Drug|UT-15C SR|Initiated at 0.125 mg BID, titrated as clinically indicated.
16189247|NCT01477333|Drug|Tyvaso Inhalation Solution|Administered as at least 9 breaths 4 times daily for at least 4 weeks prior to Baseline
16189248|NCT01477320|Drug|Pantoprazole 40 mg IV daily and tube feed.|"Patients randomized to the control group active Comparator will receive tube feed plus an Pantoprazole 40 mg IV daily."
16189249|NCT01477320|Other|Placebo and tube feed|"Patients randomized to Placebo group placebo Comparator will receive tube feed plus an Placebo."
16189250|NCT01477307|Other|Hypocaloric diet|Eurodiet,standardized hypo-caloric diet, during 3 weeks
16189251|NCT01477294|Drug|Caffeine|5 mg/ kg of body weight (capsules), twice a day (morning and afternoon), during 4 days.
16189252|NCT01477294|Drug|Placebo|Malt dextrin (5 mg/kg body mass) twice a day during 4 days
16189253|NCT01477281|Drug|Daflon|Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).
16189254|NCT01477281|Drug|Venaflon (Diosmin and Hesperidin)|Administer one tablet 2 times daily (oral), the main meals (lunch and dinner).
16189255|NCT01477268|Drug|Zoloft (antidepressant)|Zoloft 50-200 mg po od x 12 weeks
16189256|NCT01477255|Behavioral|iPad|The proposed investigation is a prospective case-control pilot study. The major goal of this pilot study is to assess the feasibility of a daily diary methodology for monitoring the experiences of recently diagnosed pediatric cancer patients and healthy-matched peers. The investigation will also examine the relationships among individual and contextual factors that influence the daily psychosocial functioning of youth with cancer in comparison to youth without cancer.
16189257|NCT01477242|Drug|Ondansetron|2mg (5mL) in < 15 kg and 4mg (10mL) in 15kg to 30kg
16189258|NCT01477216|Other|ELSA 1-9|Measuring GI and II values for Finnish foods
16189259|NCT01477203|Drug|Escitalopram|2-4 weeks, 5-10mg, max 20mg
16189260|NCT01477190|Drug|Spinal analgesia|isobaric bupivacaine 0.5% 10 mg together with preservative-free morphine was injected. The dose of morphine was based on patient's age, with 200 μg in patients aged ≤ 75 years and 150 μg in patients aged > 75 years.
16189261|NCT01477190|Drug|Patient Control Analgesia (PCA) Morphine|PCA Morphine is set to the patient for 48 hours postoperative. 2 mg. of morphine is given to a patient as much as patient requires, maximum at every 7 minutes.
16189262|NCT01477177|Device|Polar Wand carbon dioxide cryotherapy|Patients with Barrett's esophagus dysplasia will be treated with the Polar Wand device at 0 month, 2 and 4 months,6 months (with four quadrant surveillance biopsies), 8 and 10 months (treatment as necessary), and, at 12 months for final surveillance with biopsies throughout entire initial Barrett's segment length.
16189263|NCT01477164|Behavioral|High intensity aerobic exercise|Participants will perform 12-weeks of high intensity aerobic training. Training will be 5-days per week. Three days (e.g. Monday, Wednesday and Friday) will include repeated bouts of cycling for 4-minutes at ~90% maximal effort followed by 3 minutes of active rest. The other two days (e.g. Tuesday and Thursday) will be treadmill exercise for 45 minutes at 70% of maximal effort.
16189264|NCT01477164|Behavioral|Resistance exercise training|Participants will perform 12-weeks of resistance exercise training. Training will be 5-days per week of daily sessions of 60 minutes that include resistance exercise for all major muscle groups.
16189265|NCT01477164|Behavioral|Combined|The combined group will be assessed before and after 12 weeks of no exercise training, then again following 12 weeks of combined aerobic and resistance exercise training.
16189266|NCT01477151|Drug|Volatile anesthetic|"The intervention in this trial is randomization to either maintenance of anesthesia with sevoflurane or maintenance of anesthesia with isoflurane. The designated volatile anesthetic will be given at a strict minimal amount throughout the entire cardiac surgery (including cardiopulmonary bypass). This regimen (administration throughout the entire operation) has proved to have the greatest efficacy. Apart from this intervention, the anesthetic for patients participating in this trial will not be substantially different from normal practice, as the intention is to allow normal practice (with the exception of the choice of volatile anesthetic agent) to maximize the applicability and external validity of the trial. The management of anticoagulation, cardiac surgical techniques, and other aspects of the procedure will be managed in an unaltered fashion.
~No IV drug infusions will be permitted until after protamine administration."
16189267|NCT01477138|Procedure|pacemaker implantation, AAI(R)-DDD(R) versus DDD(R)|Indication for pacemaker implantation: sick sinus syndrome in conformity with the current guidelines. Only market-released CE certified 2-chamber cardiac pacemakers and electrodes are used. The implantation is done according to the applicable standards. Active RV-lead is positioned on the right ventricular septum.
16189268|NCT01477125|Behavioral|Flex working memory training|30-40 minutes of working memory training, 5 days a week for 5 weeks
16189279|NCT01477021|Drug|cyclophosphamide|Given IV
16189282|NCT01477008|Device|BiPhasic Cartilage Repair Implant|1 or 2 BiCRI devices, depending on lesion size
16189283|NCT01477008|Procedure|Marrow Stimulation|Microfracture or Subchondral Drilling
16189284|NCT01476982|Device|ClearView Scan|Assessment with ClearView device
16189285|NCT01476969|Device|Remote ischemic postconditioning|the treatment group consisted of three 4-minute cycles left lower limb ischemia,induced by inflating a blood pressure cuff on the lower limb to 600 mmHg with an intervening 4 minutes of reperfusion ,during which time the cuff was deflate;the control group consisted of placing an uninflated cuff on the left lower limb for 24 minutes.The postconditioning protocol was applied after the aortic cross-clamping.
16189287|NCT01476930|Procedure|cupping and serkangabin syrup|wet cupping serkangabin syrup
16189288|NCT01476930|Drug|conventional migraine drug treatment|nortriptyline ,propranolol ,ergotamine , sumatriptan tablets
16189289|NCT01476917|Device|Attune Sleep Apnea System|Observation of Attune Sleep Apnea System for use during sleep.
16189290|NCT01476904|Drug|Placebo|0 mcg/inhalation, 2 inhalations QID
16189291|NCT01476904|Drug|Primatene Mist|220 mcg/inhalation, 2 inhalations QID
16189292|NCT01476904|Drug|Epinephrine inhalation|125 mcg/inhalation, 2 inhalations QID
16189293|NCT01476891|Other|Immediate MBSR|Immediate Online MBSR Group. Participation in a standardized manual-based 8-week online MBSR program.
16189294|NCT01476891|Other|Wait-list Control Group.|Wait-list Control Group. The control group will receive the next available online MBSR program.
16189295|NCT01476878|Device|Frameless Stereotactic Radiosurgery with radiation mask|Linac-based radiosurgery using a thermoplastic mask (single treatment)
16189296|NCT01476839|Biological|basiliximab|Given IV
16189297|NCT01476839|Drug|carmustine|Given IV
16189298|NCT01476839|Drug|etoposide|Given IV
16189299|NCT01476839|Drug|cytarabine|Given IV
16189300|NCT01476839|Drug|melphalan|Given IV
16189301|NCT01476839|Other|pharmacological study|Correlative studies
16189302|NCT01476839|Other|laboratory biomarker analysis|Correlative studies
16189303|NCT01476839|Procedure|autologous hematopoietic stem cell transplantation|Undergo autologous hematopoietic progenitor cell infusion
16189304|NCT01476839|Biological|yttrium Y 90-labeled basiliximab|Given IV
16189309|NCT01476800|Drug|YM178 OCAS|oral
16189310|NCT01476800|Drug|Ketoconazole|oral
16189311|NCT01476787|Drug|Rituximab|375 mg/m2 on days 1, 8, 15 and 22 of cycle 1, day 1 of cycles 2 to 6; 8 weeks later responding patients continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.
16189312|NCT01476787|Drug|Lenalidomide|20-mg on days 2-22 every 28 days x 6 cycles, if CR then 10-mg on days 2-22 every 28 days for 12 cycles. PR after 6 cycles, continue 20 mg for 3~6 cycles and then 10 mg on days 2-22 every 28-day cycles for upto 18 cycles
16189313|NCT01476787|Drug|Rituximab-CHOP|7 to 8 weeks later responding patients will continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.
16189314|NCT01476787|Drug|Rituximab-CVP|7 to 8 weeks later responding patients will continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.
16189315|NCT01476787|Drug|Rituximab-Bendamustine|7 to 8 weeks later responding patients will continue with 375 mg/m2 rituximab every 8 weeks for 12 cycles.
16189316|NCT01476774|Drug|Buprenorphine Transdermal System|"Titration period（21 days）:BTDS 5 mg or oral tramadol CR 100 mg bid, and will then be titrated, if necessary, a maximum of BTDS 20 mg or oral tramadol CR 200 mg bid will be given.
~maintenance period(5 week):Patients will continue at a dosage level that provided acceptable pain control ."
16189317|NCT01476774|Drug|Buprenorphine Transdermal System|"Titration period（21 days）:BTDS 5 mg or oral tramadol CR 100 mg bid, and will then be titrated, if necessary, a maximum of BTDS 20 mg or oral tramadol CR 200 mg bid will be given.
~maintenance period(5 week):Patients will continue at a dosage level that provided acceptable pain control ."
16189318|NCT01476761|Device|Microcutter XPRESS and Microcutter XCHANGE|Surgical stapling devices
16189319|NCT01476748|Device|LaproStop|One of the subject's trocars will be randomized to be used with a LaproStop device.
16189320|NCT01476735|Other|individual preparation for colonoscopy|The volume of polyethylene glycol solution depends on risk factors presented in each patient. Time of administration of second dose will be confirmed according to the time of colonoscopy. In case of constipation an enema before colonoscopy will be administered. All patients will give educational booklet of preparation before colonoscopy
16189321|NCT01476722|Device|OPTI-FREE PureMoist multipurpose disinfecting solution|FDA-approved, multipurpose disinfecting solution used as indicated for cleaning, rinsing, reconditioning, disinfecting, and storing silicone hydrogel and soft contact lenses on a daily wear basis for 30 days
16189322|NCT01476696|Drug|Prasugrel|Administered orally
16189323|NCT01476683|Drug|Racecadotril|Film-coated tablet
16189324|NCT01476683|Drug|Racecadotril|Racecadotril Powder Blend
16189325|NCT01476683|Drug|Racecadotril|Marketed Capsule
16189326|NCT01476683|Drug|Racecadotril|Marketed Film-coated Tablet
16189327|NCT01476670|Other|Monitoring|Transcranial Doppler will be used to assess the cerebral autoregulation and carbon dioxide reactivity of patients with posterior fossa tumor
16189328|NCT01476657|Drug|IPI-145 (duvelisib)|Oral Twice A Day (BID) Dosing
16189329|NCT01476644|Other|Clinical evaluation|Biomicroscopy (look at front of eye), ophthalmoscopy (look at back of eye), visual acuity, visual fields, intraocular pressure, spectral domain optical coherence tomography, Pelli-Robson and the Spaeth-Richman Contrast Sensitivity tests
16189330|NCT01476644|Other|Performance based measures|Compressed Assessment of Ability Related to Vision (CAARV) items include: 1) computerized motion detection; 2) recognizing facial expressions; 3) reading street signs; and 4) finding objects in a room
16189365|NCT01476410|Genetic|polymorphism analysis|Optional correlative studies
16189366|NCT01476397|Other|Control infant formula|partially hydrolyzed whey infant formula consumed ad libitum throughout study
16192928|NCT01450007|Drug|Dexamethasone|8 mg dexamethasone (perineural)
16189331|NCT01476644|Other|Subjective measures of vision-related quality of life|National Eye Institute Visual Functioning Questionnaire 25 (NEI-VFQ-25) includes a series of questions pertaining to vision or feelings about a vision condition and the Modified Glaucoma Symptom Scale (MGSS) includes a series of questions pertaining to eye comfort.
16189332|NCT01476631|Behavioral|Walking|"7 days prior to baseline participants must wear a blinded pedometer
~At baseline information on the blinded pedometer will downloaded to the computer for analysis as well as number of days worn and hours of wear. Sociodemographic, cancer risk factors, height/weight, fast blood draw to check levels on insulin, C-peptide, IL-6 and PEG-2 and questionnaires PPAQ, Exercise Confident Survey and Sallis Social Support Scale, Day/night; Home/Work, neighborhood safety, HINTS, IPAPS, CES-D, Brief COPE, Urban and Life Stress Scale."
16189333|NCT01476618|Other|No Intervention|No Intervention
16189334|NCT01476605|Procedure|Dextrose prolotherapy|PrT-D solution is 4 mL 50% dextrose, 3 mL normal saline, and 2 mL 2% lidocaine
16189335|NCT01476605|Procedure|PrT-DMS|PrT-DMS. 1.0 mL 5% morrhuate sodium + 1.5 mL 50% dextrose, 1 mL 2% lidocaine and 3.5 mL normal saline.
16189336|NCT01476605|Procedure|Platelet Rich Plasma injection|Platelet rich plasma injection therapy (PRP) uses components of autologous blood to promote healing in chronically diseased joint tissues.
16189337|NCT01476592|Dietary Supplement|Resveratrol|5 gm/day of resveratrol orally, in two divided doses of 2.5 gm each without a break in therapy for a total of three cycles.
16189338|NCT01476579|Device|Cardiac Computer Tomography|Compare Cardiac CT with reference standard wich is conventional invasive coronary angiography.
16189339|NCT01476566|Behavioral|Educational intervention|Peer continuous medical education (CME) groups in general practice will be recruited to a cluster randomised educational intervention study. Participating groups will be randomised either to an intervention- or a control group. A multifaceted intervention has been tailored where key components are educational outreach visits (EOV) to the CME-groups, audit, and feedback. Trained GPs will conduct the EOVs during which evidence-based recommendations for diagnosis and treatment of HF will be presented. A software will be handed out for installation on participants' practice computers, enabling collection of diagnosis- and prescription-data. The captured data will subsequently be linked to corresponding data from the Norwegian Prescription Database (NorPD).
16189340|NCT01476553|Procedure|Extensive Intraperitoneal Lavage (EIPL)|"EIPL is performed after completing resection and lymphadenectomy: the abdominal cavity has to be washed ten times with one liter Ringer's solution. Each liter has to be well dispersed manually in the abdominal cavity, and removed and disposed completely. 100 ml of the last liter of lavage fluid will be harvested and sent for analysis.
~Contrary to the Japanese trial, Ringer's solution will be used instead of normal saline solution because of a presumed higher likelihood of peritoneal adhesions when employing the latter (7). Ringer's solution is the standard used for all intraperitoneal lavage procedures at the study centre. To avoid hypothermia, the lavage fluid will be warmed to body temperature (37° Celsius)."
16189341|NCT01476540|Device|Deep Brain Stimulation|Deep Brain Stimulation (DBS) is a neurosurgical procedure involving the implantation of deep brain electrodes, connected via a subcutaneous extension wire, to an implantable pulse generator (IPG, or 'battery') that is implanted below the collarbone.
16189342|NCT01476527|Procedure|Deep Brain Stimulation|Deep Brain Stimulation (DBS) is a neurosurgical procedure involving the implantation of deep brain electrodes, connected via a subcutaneous extension wire, to an implantable pulse generator (IPG, or 'battery') that is implanted below the collarbone
16189343|NCT01476514|Other|No intervention|The testing will be the same for healthy volunteers and patients with a mutations in the glycine channel.
16189344|NCT01476501|Drug|Vitamin D3|Randomized into 1 of 2 oral vitamin D3 softgel capsule supplementation strategies: 1) 2,000 IU/day (2 x 1,000IU/capsule each day) or 2) 40,000 IU/month (4 x 10,000IU/capsule last day of each month), for 6 months each.
16189345|NCT01476488|Drug|tacrolimus|
16189346|NCT01476475|Drug|Insulin glargine /lixisenatide Fixed Ratio Combination|FRC was self-administered by subcutaneous (SC) injection within 1 hour before breakfast using pen-type injector (Tactipen®): 100 U/ml insulin glargine and 50 mcg Lixisenatide (ratio of 2 U/1 mcg). The initial dose was 10 U/5 mcg and then dose was adjusted weekly to reach and maintain fasting self-monitored plasma glucose (SMPG) of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L.
16189347|NCT01476475|Drug|Insulin glargine|Insulin glargine (100 U/ml) was self-administered by SC injection before breakfast using pen-type injector (Lantus® Solostar®). The initial daily dose of insulin glargine was 10 U and then dose was adjusted weekly to reach and maintain fasting SMPG of 80 mg/dL to 100 mg/dL (4.4 mmol/L to 5.6 mmol/L).
16189348|NCT01476475|Drug|Metformin (Background drug)|Pharmaceutical form: Tablet; Route of administration: oral administration. To be kept at stable dose (≥1.5 g/day) throughout the study.
16189349|NCT01476449|Drug|Ranibizumab|Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
16189350|NCT01476449|Drug|Ranibizumab|Pars plana injection of ranibizumab 0.5mg into the vitreous cavity.
16189351|NCT01476436|Other|Low carbohydrate dietary advice|Dietary advice
16189352|NCT01476436|Other|Continue usual diet|Dietary advice
16189353|NCT01476423|Drug|activated recombinant human factor VII|A prospective, observational multi-national registry collecting data and evaluating the efficacy and safety of rFVIIa in patients with GT with past or present refractoriness to platelet transfusions. The registry will also collect data from a broader range of GT patients treated with systemic haemostatic treatment (with or without antifibrinolytic drugs or other agents) used in the clinics. Data collection will continue for a maximum of six years. Baseline data as well as data obtained during either bleeding episodes or invasive procedures/surgeries will be recorded in the registry.
16189354|NCT01476410|Drug|brentuximab vedotin|Given IV
16189355|NCT01476410|Drug|doxorubicin hydrochloride|Given IV
16189356|NCT01476410|Drug|vinblastine|Given IV
16189357|NCT01476410|Drug|dacarbazine|Given IV
16189358|NCT01476410|Procedure|quality-of-life assessment|Ancillary studies
16189359|NCT01476410|Genetic|DNA analysis|Optional correlative studies
16189360|NCT01476410|Genetic|RNA analysis|Optional correlative studies
16189361|NCT01476410|Radiation|fludeoxyglucose F 18|Correlative studies
16189362|NCT01476410|Procedure|positron emission tomography|Correlative studies
16189363|NCT01476410|Other|laboratory biomarker analysis|Optional correlative studies
16189364|NCT01476410|Other|immunohistochemistry staining method|Optional correlative studies
16189367|NCT01476397|Other|Test infant formula|partially hydrolyzed whey formula with probiotic
16189368|NCT01476384|Dietary Supplement|Glucose|Glucose drink: 75 gram dextrose monohydrate, dissolved in 250 ml water
16189369|NCT01476384|Dietary Supplement|Placebo|250 ml water
16189370|NCT01476371|Behavioral|Mindfulness-based group treatment|An 8-week course of mindfulness-based group treatment (one 2-hour session per week; 10 patients per group). Each group session will be led by two mindfulness instructors, who will lead the patients through the Here & Now mindfulness program. Between sessions, patients will perform additional mindfulness practice at home via the Internet.
16189371|NCT01476358|Dietary Supplement|Vitamin A (retinyl palmitate).|"Active Comparator (Vitamin A): 1 capsule containing oil carrier and 50,000IU Vitamin A, within 48hs of birth
~Placebo Comparator: 1 capsule containing oil carrier and 0IU Vitamin A, within 48hs of birth"
16189372|NCT01476345|Drug|LY2963016|Administered subcutaneously
16189373|NCT01476345|Drug|Lantus|Administered subcutaneously
16189374|NCT01476332|Drug|cis-urocanic acid 0,5% eye drops|one drop three times a day, applied on one eye at Part 1 and on both eyes at Part 2
16189375|NCT01476332|Drug|cis-urocanic acid 2.5% eye drops|one drop three times a day, applied on one eye at Part 1 and on both eyes at Part 2
16189376|NCT01476332|Drug|Placebo for cis-UCA, eye drops|one drop three times a day, applied on one eye at Part 1 and on both eyes at Part 2
16189377|NCT01476319|Other|video|The intervention group includes patients who obtain information about percutaneous cholecystostomy from a video will view at their bedside on a laptop.
16189378|NCT01476306|Other|Telemedicine|Patient will receive care using HIPAA-compliant web-based videoconferencing rather than their usual in-patient care.
16189379|NCT01476306|Other|Usual care|Patients in this group will receive care as they usually do with the physician.
16189380|NCT01476280|Drug|palonosetron|0.075mg immediately before induction of anesthesia
16189381|NCT01476280|Drug|Ramosetron|0.3mg immediately before induction of anesthesia
16189382|NCT01476267|Drug|dalcetrapib|Single oral radiolabeled dose
16189383|NCT01476241|Procedure|PEG tube placement|Percutaneous endoscopic gastrostomy
16189384|NCT01476228|Device|EEG recording|EEG recording
16189385|NCT01476215|Drug|Paracetamol fast dissolution suspension|
16189386|NCT01476215|Drug|Paracetamol medium dissolution suspension|
16189387|NCT01476215|Drug|Paracetamol slow dissolution suspension|
16189388|NCT01476215|Drug|Paracetamol|
16189389|NCT01476202|Drug|nicotine|nicotine in the form of a mouth strip, lozenge and gum
16189390|NCT01476189|Drug|Experimental paracetamol formulation|experimental
16189391|NCT01476189|Drug|Marketed paracetamol|Marketed paracetamol
16189392|NCT01476189|Drug|Higher dose marketed paracetamol|Higher dose marketed paracetamol
16189393|NCT01476176|Drug|Experimental paracetamol|experimental paracetamol with caffeine
16189394|NCT01476176|Drug|Paracetamol marketed formulation|marketed formulation containing caffeine
16189395|NCT01476163|Drug|migalastat HCl|150 mg capsule taken every other day by mouth. An inactive reminder capsule may be provided to take on the days in between migalastat HCl
16189396|NCT01476137|Drug|GSK1120212|MEK inhibitor
16189397|NCT01476137|Drug|GSK2110183|AKT inhibitor
16189398|NCT01476124|Drug|morphine Placebo|Morphine Placebo
16189399|NCT01476124|Drug|GEn 600 mg|Gabapentin enacarbil 600 mg
16189400|NCT01476124|Drug|Morphine|morphine extended release 60 mg
16189401|NCT01476124|Drug|GEn Placebo|Gabapentin enacarbil placebo
16189402|NCT01476098|Drug|Placebo|SB-705498 placebo
16189403|NCT01476098|Drug|SB-705498|400 or 600mg oral SB-705498
16189404|NCT01476085|Radiation|ML10|[18F]ML10 radioligand apoptosis biomarker
16189405|NCT01476072|Other|MRI scan|MRI scan only, methodology study with no other intervention
16189406|NCT01476059|Other|Telephone follow-up|Asthmatic children being treated, who will be given medical guidance and therapeutic guidance through telephone calls at every fifteen days to the parents or guardians, performed by trained professionals.
16189407|NCT01476059|Other|No telephone follow-up|Asthmatic children being treated, who will be given medical guidance without telephone follow-up calls to parents or guardians.
16189408|NCT01476046|Drug|GSK1995057 single dose|Single intravenous dose
16189409|NCT01476046|Drug|Placebo|Single intravenous dose
16189410|NCT01476033|Dietary Supplement|nutraceutical group|6 capsules of supplement or placebo for 8wk
16189411|NCT01476007|Drug|oral Cobalamin (vitamin B12)|Intervention group: oral Optovite® B12 1000 gammas.
16189412|NCT01476007|Drug|intramuscular Cobalamin (vitamin B12)|Control group: intramuscular Optovite® B12 1000 gammas.
16189413|NCT01475994|Other|Grass pollen : Dactylis glomerata|The subjects will be challenged for 4 hours on two consecutive days (Day 1 and Day 2) with either 4000 pollen grains/m3 of dactylis glomerata pollen.
16189414|NCT01475994|Other|Challenge with clean air|The subjects will be challenged for 4 hours on two consecutive days (Day 1 and Day 2) with clean air.
16189415|NCT01475981|Drug|JTK-853 or Placebo|Tablets, single dose, fasted, fed or high-fat fed condition
16189416|NCT01475968|Other|Ultrafine Air Pollution Particulate Matter|Ultrafine (particle diameter less than 2.5 microns) Air Pollution Particulate Matter, concentrated from the ambient air outside of the Chapel Hill EPA Human Studies Facility
16189417|NCT01475968|Other|Filtered Air|Filtered Air
16189418|NCT01475955|Drug|Broad Area ALA 1-hour incubation|20% ALA, broad area, 1 hour incubation
16189419|NCT01475955|Drug|Broad Area ALA 2 hour incubation|20% ALA broad area 2-hour incubation
16189420|NCT01475955|Drug|broad area ALA 3-hour incubation|20% ALA broad area 3 hour incubation
16189421|NCT01475955|Drug|Spot ALA 2 hour incubation|20% ALA spot 2 hour incubation
16189422|NCT01475955|Drug|Vehicle PDT|Levulan Kerastick containing vehicle ingredients only.VEH group will be randomized (1:1:1:1) to be balanced for the four active groups; broad area application for 1, 2 or 3 hours or spot application for 2 hours prior to BLUE light treatment. Subjects receiving VEH will be considered a single treatment group.
16189423|NCT01475955|Device|Blue Light Treatment|10 J/cm2 blue light delivered at 10 mW/cm2
16189424|NCT01475942|Dietary Supplement|Probiotic|4 month probiotic intervention with 1 month run-in and 1 month wash-out. Probiotic given once a day.
16189425|NCT01475929|Dietary Supplement|Probiotic supplement|A single strain probiotic supplement given at two doses
16189426|NCT01475916|Behavioral|Educational program: consultation with paediatric pulmonologist|Longitudinal prospective study
16189427|NCT01475903|Procedure|Longitudinal sleeve gastrectomy|The main objective of this study is to assess during a 2-year prospective follow-up, the prevalence of nutrient deficiencies in patients undergoing a longitudinal sleeve gastrectomy for morbid obesity
16189428|NCT01475890|Dietary Supplement|Vitamin D3|7000IU per day of vitamin D3 for 12 months.
16189429|NCT01475890|Dietary Supplement|Placebo|Once a day for 12 months.
16189430|NCT01475877|Drug|Bromfenac|Bromfenac 0.09% 1 drop in study eyes q day
16189431|NCT01475864|Procedure|ERCP with metal stent|ERCP will be used so that a metal stent can be placed to facilitate the removal of the biliary stone
16189432|NCT01475851|Drug|GSK548470 300 mg tablet|Blue tablets containing 300 mg of tenofovir disoproxil fumarate
16189433|NCT01475838|Drug|PI|PI administered according to prescribing information; allowed PIs include atazanavir (ATV), darunavir (DRV), fosamprenavir (FPV), lopinavir (LPV), or saquinavir (SQV)
16189434|NCT01475838|Drug|RTV|RTV administered according to prescribing information FTC/TDF administered according to prescribing information
16189435|NCT01475838|Drug|FTC/TDF|FTC/TDF (200/300 mg) administered according to prescribing information
16189436|NCT01475838|Drug|Stribild|Stribild (E/C/F/TDF) (150/150/200/300 mg) STR administered orally once daily with food
16189437|NCT01475825|Drug|mipomersen sodium 200 mg|Subcutaneous mipomersen 200 mg once weekly
16189438|NCT01475825|Drug|Placebo|Placebo vehicle for subcutaneous injection.
16189439|NCT01475825|Drug|mipomersen sodium 70 mg|Subcutaneous mipomersen 70 mg thrice weekly
16189440|NCT01475812|Other|Hyperinflation and ADL|Assessment of dynamic pulmonary hyperinflation during activities of daily living in COPD patients.
16189441|NCT01475799|Device|Replacement of the Aortic Stenotic Valve|Treatment for patients with Severe Aortic Stenosis.
16189442|NCT01475786|Biological|Low Dose: 16 mg VM202|"Subjects in the Low Dose Group (8mg VM202 / leg) will receive the following intramuscular injections in each calf:
~Day 0 - 32 injections / calf:
~• 16 injections of 0.5mL of VM202 / calf - (4 mg of VM202 / calf)
~Day 14 - 32 injections / calf:
~• 16 injections of 0.5mL of VM202 / calf - (4 mg of VM202 / calf)"
16189443|NCT01475786|Biological|High Dose: 32 mg VM202|"Subjects in the High Dose Group (16 mg VM202 / leg) will receive the following intramuscular injections in each calf:
~Day 0
~• 32 injections of 0.5mL of VM202 / calf (8 mg of VM202 / calf)
~Day 14
~• 32 injections of 0.5mL of VM202 / calf (8 mg of VM202 / calf)"
16189444|NCT01475786|Other|Control- Placebo (normal saline)|subjects will receive thirty-two (32) 0.5 mL injections of normal saline on Day 0 and Day 14.
16189445|NCT01475760|Other|K2CG chewing gum (20mg chitosan)|All participating subjects will chew gum TID for 14 days beginning on Day 1 through Day 14
16189446|NCT01475760|Other|K2CG chewing gum (60mg chitosan)|"Subjects will be randomized in a 1:1 fashion to either chew gum or continue with Standard of Care (no intervention)if they have a change in serum phosphorus of greater than or equal to -0.2 mg/dL from:
~Baseline (defined as the mean of values from Visit 2, 3, and 4) to the end of active treatment (defined as the mean of Visit 6 and 7) AND/OR Baseline (defined as the mean of values from Visit 2, 3, and 4) and end of wash out (defined as Visit 7 (Day 22).
~If randomized: Chew gum TID for 14 days beginning on Day 29 through Day 42"
16189447|NCT01475734|Biological|albiglutide|subcutaneous injection
16189448|NCT01475734|Biological|placebo|subcutaneous injection
16189449|NCT01475721|Drug|ADVAIR 100/50mcg|fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months
16189450|NCT01475721|Drug|ADVAIR 250/50mcg|fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months
16189451|NCT01475721|Drug|ADVAIR 500/50mcg|fluticasone propionate/salmeterol combination (500/50mcg) twice daily (AM and PM) for 6 months
16189452|NCT01475721|Drug|FLOVENT 100mcg|fluticasone propionate (100) twice daily (AM and PM) for 6 months
16189453|NCT01475721|Drug|FLOVENT 250mcg|fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months
16189454|NCT01475721|Drug|FLOVENT 500mcg|fluticasone propionate (500mcg) twice daily (AM and PM) for 6 months
16189455|NCT01475708|Drug|Doxycycline|100 mg PO bid, 14 days
16189456|NCT01475695|Drug|14C GSK2251052|1500 mg iv dose GSK2251052
16189457|NCT01475669|Biological|Fibrinogen Concentrate (Human) (FCH)|Single dose infused intravenously within 5 minutes of the completion of the measurement of the 5-minute bleeding mass; the dose is determined individually based on the measured maximum clot firmness (MCF) and subject body weight
16189458|NCT01475669|Biological|Placebo|Single dose of sodium chloride solution infused intravenously within 5 minutes at a volume equivalent to that needed for FCH
16189459|NCT01475656|Drug|levetiracetam|Infants in the both groups will receive 50 mg/kg IV levetiracetam after (continued) seizures are EEG confirmed.
16189460|NCT01475643|Drug|Loteprednol etabonate|1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days.
16189461|NCT01475643|Drug|Prednisolones acetate|1-2 Ophthalmic drops administered to study eye four times daily (QID) for 14 days post surgery. Tapered to twice daily (BID) for 7 days. Then once daily (QD) for 7 days.
16189462|NCT01475630|Procedure|physical therapy|mobilisation of the jaw, exercises, boostering information on avoiding parafunctions
16189463|NCT01475630|Procedure|control|relaxation
16189464|NCT01475617|Dietary Supplement|AquaVanta Chewable Tablet|AquaVanta Chewable Tablet (proprietary formulation of vitamin and minerals) 2 times a day for 6 months
16189465|NCT01475617|Dietary Supplement|Flinstones Complete|Flinstones Complete Multivitamin 2 times a day for 6 months
16189466|NCT01475617|Dietary Supplement|Nature Made Calcium Softgels|Nature Made Calcium Softgels (Calcium Carbonate 600 mg and Vitamin D 200 mg) three times a day for 6 months
16189467|NCT01475617|Dietary Supplement|Nature Made Calcium Softgels|Nature Made Calcium Softgels (Calcium Carbonate 600 mg and Vitamin D 200 mg) three times a day for 6 months
16189468|NCT01475617|Dietary Supplement|Twin Labs Iron Caps|Twin Labs Iron Caps (Ferrous Fumarate) 18 mg per day for menstruating women for 6 months
16189469|NCT01475617|Dietary Supplement|Rexall Vitamin B12 Tablet|Rexall Vitamin B12 Tablet (Cyanocobalamin 500 mcg)per day for 6 months
16189470|NCT01475604|Device|Ivivi Torino II|Targeted pulsed electromagnetic field treatment for 4 weeks post-surgery
16189471|NCT01475604|Device|Ivivi Torino II|Sham treatment for 4 weeks post-surgery
16189472|NCT01475591|Behavioral|Web-based multimodal rehabilitation based on cognitive based principles|The patient will be randomized to either the interventions group (multimodal pain rehabilitation with an added web-based multimodal rehabilitation with CBT-influences) or a control group (multimodal pain rehabilitation).
16189473|NCT01475578|Drug|STA-1|STA-1 capsule (manufactured by Sinphar Tian-Li (Hangzhou) Pharm. Co., Ltd.; Batch number: 020121), 2 capsules/time, 3 times/day, orally
16189474|NCT01475578|Drug|Ergoloid Mesylates tablet|Ergoloid Mesylates tablet (manufactured by Tianjin Huajin Pharmaceutical Factory; Batch number: 011230), 2 tablets/time, 3 times/day, orally before meal
16189475|NCT01475552|Drug|Abciximab|Patients, who showed PRU >270 unit and were randomized to abciximab group,were treated with abciximab in addition to conventional antiplatelet treatment (aspirin+clopidogrel).
16189476|NCT01475552|Drug|control|"Patients,who showed PRU >270 unit and were randomized to control group,were treated with conventional antiplatelet therapy (aspirin+clopidogrel) during PCI and follow up periods.
~Aspirin : D-1 300mg, D0-30 100mg qd Clopidogrel : D-1 300mg, D0-30 75mg qd"
16189477|NCT01475539|Biological|Injectable inactivated types 1, 2 and 3 poliovirus + Live oral Polio|0.5 mL, Intramuscular + 1g dragee candy oral dose
16189478|NCT01475539|Biological|Injectable inactivated types 1, 2 and 3 poliovirus + Live oral Polio|0.5 mL, Intramuscular + 1g dragee candy oral dose
16189479|NCT01475539|Biological|Live oral poliovirus type 1, 2 and 3|1g dragee candy, oral
16189480|NCT01475526|Other|El Valor de Nuestra Salud Store Intervention|Changes to physical and social environment of grocery stores through implementation of the El Valor de Nuestra Salud intervention.
16189481|NCT01475513|Drug|Ortho Cyclen®|Ethinyl estradiol 35 mcg and norgestimate 0.25 mg (oral) will be taken as one tablet daily for 21 days per month followed by a 7-day pill-free period per cycle. Duration of the study is for 6 cycles of this birth control pill.
16189482|NCT01475500|Procedure|Sputum sample|This is a collection of sputum (mucous) you cough up. Three morning samples will be collected at one time. Sputum will be collected at baseline, year 1, year 2 and year 5.
16189483|NCT01475500|Procedure|Pulmonary function tests|A series of different breathing tests designed to measure lung function and to determine the presence or absence of chronic obstructive pulmonary disease will be performed at baseline.
16189484|NCT01475500|Radiation|Computerized tomography (CT) scan of the chest|A CT scan uses x-rays to take detailed pictures of the chest. Performed at baseline, year 2 and year 5. If nodules are present, CT scans will be performed every 3 months for the first year of the study.
16189485|NCT01475500|Other|Buccal epithelium collection|Collect cells from the inside of the cheek. Samples will be collected at baseline and yearly to year 5.
16189486|NCT01475500|Procedure|Nasal brushings|A cytobrush is used to remove cells on the surface of the inside of the nose. Samples will be collected at baseline and yearly to year 5.
16189487|NCT01475500|Procedure|Bronchoscopy|A flexible tube with a light and a camera will be inserted through the nose or mouth, and into the lungs to look at the airway. Bronchial tissue will be obtained.
16189488|NCT01475500|Procedure|Bronchoalveolar lavage|During a bronchoscopy, a flexible tube with a light and a camera is passed through the mouth or nose into the lungs and fluid is squirted into a small part of the lung and collected for examination. Bronchoscopies will be performed at baseline and at year 5.
16189489|NCT01475500|Procedure|Blood sample collection|A venous blood sample will be collected for testing of biomarkers and other relevant tests. Blood will be taken at baseline and yearly to year 5.
16189490|NCT01475500|Procedure|Urine sample|Urine will be collected for routine urine tests at baseline and yearly to year 5.
16189491|NCT01475500|Procedure|Questionnaire-data collection|A questionnaire about the patient's health, medical, and smoking history. Administered at baseline and yearly to year 5. Data will be taken from patient interviews and from the medical record.
16189492|NCT01475487|Procedure|Utrasound guided cricothyrotomy|Utrasound guided cricothyrotomy
16189493|NCT01475474|Device|Renew Insert|The Renew Insert is indicated for the management of accidental bowel leakage due to bowel incontinence. The Renew Insert is designed for self-insertion to seal and help prevent the involuntary leakage of stool from the rectum.
16189494|NCT01475461|Drug|Placebo|double-dummy placebo tablets administered once-daily for 84-days
16189495|NCT01475461|Drug|PF-04937319 - 3mg|PF-04937319 3mg administered as tablets once-daily for 84-days
16189496|NCT01475461|Drug|PF-04937319 - 20mg|PF-04937319 20mg administered as tablets once-daily for 84-days
16189497|NCT01475461|Drug|PF-04937319 - 50mg|PF-04937319 50mg administered as tablets once-daily for 84-days
16189498|NCT01475461|Drug|PF-04937319 - 100mg|PF-04937319 100mg administered as tablets once-daily for 84-days
16189499|NCT01475461|Drug|Sitagliptin - 100mg|Sitagliptin 100mg administered as tablets once-daily for 84-days
16189500|NCT01475448|Other|Long distance training|Long distance training during four months, 3 times per week
16189501|NCT01475448|Other|Walking training|Walking training during four months, three times per week
16189502|NCT01475435|Procedure|non- surgical periodontal treatment|scaling and root planning
16189503|NCT01475435|Procedure|Prophylaxis|Periodontally healthy patients will receive oral hygiene instructions and prophylaxis.
16189504|NCT01475422|Behavioral|Conversation Maps Diabetes Education|The Conversation Maps program is a set of innovative, interactive diabetes education tools developed by the Healthy Interactions, and endorsed by the American Diabetes Association. It consists of four conversation maps covering: 1) how the body and diabetes works, 2) healthy eating and physical activity, 3) treatment with medication and monitoring blood glucose, and 4) reaching the targets with insulin (a fifth map covering gestational diabetes will not be used in this study), and a program manual to help educators successfully implement the program. Participants will be followed for an expected average of 12 weeks.
16189505|NCT01475422|Behavioral|Usual Care|Patients are followed in the medical appointments for evaluation and treatment of diabetes mellitus, according to service routine. Participants will be followed for an expected average of 12 weeks.
16189575|NCT01474915|Drug|Aprepitant|Subject will receive 40 mg of Aprepitant versus placebo PO before anesthesia induction
16189870|NCT01472822|Dietary Supplement|Omija extract.|Omija extract 1.2g/day for 12weeks
16189506|NCT01475409|Biological|QuantiFERON-TB Gold In-Tube (QFT-GIT)|Patients were randomized to undergo, on the same day, TST and QFT-GIT by means of a randomization list to generate the order by which the 2 tests had to be executed. QFT-GIT was repeated after 3 and 6 months since TNF antagonist onset
16189507|NCT01475396|Behavioral|exercise|
16189508|NCT01475383|Drug|PF-03654746|20-day dose titration phase: all dosages in capsules starting at 0.25 mg qd x 5 d, then 0.5 mg qd x 5 d, then 1.0 mg qd x 5 d, then 2.0 mg qd x 5 d. If a subject has intolerable, severe, or serious AEs after taking 2 mg qd for 1 to 5 days of dosing, the dose will be decreased by the investigator to 1 mg qd. If, in the investigator's opinion, the subject is determined to be unlikely to tolerate continued dosing at a dose of 1 mg qd, the subject should be discontinued from the study. Subjects remaining in the study will proceed to the 3-week Stable Dosing Phase; doses will be 2 mg daily x 21 days or 1 mg daily x 21 days.
16189509|NCT01475383|Drug|Placebo|once daily dosing of placebo capsules following the dosing scheme described in 1.1.
16189510|NCT01475383|Drug|Placebo|once daily dosing of placebo capsules following the dosing scheme described in 1.1
16189511|NCT01475383|Drug|PF-03654746|20-day dose titration phase: all dosages in capsules starting at 0.25 mg qd x 5 d, then 0.5 mg qd x 5 d, then 1.0 mg qd x 5 d, then 2.0 mg qd x 5 d. If a subject has intolerable, severe, or serious AEs after taking 2 mg qd for 1 to 5 days of dosing, the dose will be decreased by the investigator to 1 mg qd. If, in the investigator's opinion, the subject is determined to be unlikely to tolerate continued dosing at a dose of 1 mg qd, the subject should be discontinued from the study. Subjects remaining in the study will proceed to the 3-week Stable Dosing Phase; doses will be 2 mg daily x 21 days or 1 mg daily x 21 days.
16189512|NCT01475370|Drug|OCV-501|"Before the recommended dose will be decided OCV-501 will be subcutaneously administered once a week at the dose in the study 311-10-001.
~After the recommended dose will be decided OCV-501 will be subcutaneously administered once a week at the recommended dose."
16189513|NCT01475357|Other|Arm 1: NPO by mouth pre-operative|Current treatment for infants born with cardiac defects awaiting surgery is to keep them NPO pre-operatively. Arm 1 will make no changes to this current policy.
16189514|NCT01475357|Other|Arm 2: Fresh Breast Milk pre-operative|Infants randomized to Arm 2 of the study will receive their mother's own breast milk pre-operatively.
16189515|NCT01475344|Drug|Human Fibrinogen Concentrate|"intravenous infusion over 5 min/vial:
~Body Weight: < 30 kg / 30-60 kg / 60 - 90 kg / > 90 kg
~No. of vials: 1 vial (100 ml) / 2 vials (200 ml) / 3 vials (300 ml) / 4 vials (400 ml)
~Fibrinogen Concentrate: 1.5 g / 3 g / 4.5 g / 6 g
~Immediately after admission to hospital, the patient's parameters including blood collection (see below) will be measured for the second time (T2), if applicable, after the end of administration of the study drug. Additional measurements will be made 3 hours (T3), 9 hours (T4), and 24 hours (T5), 48 hours (T6) and one week after admission (T7). 30 days after inclusion in the study, a final investigation is planned (T8)."
16189516|NCT01475344|Drug|Placebo|"intravenous infusion over 5 min/vial:
~Body Weight: < 30 kg / 30-60 kg / 60 - 90 kg / > 90 kg
~No. of vials: 1 vial (100 ml) / 2 vials (200 ml) / 3 vials (300 ml) / 4 vials (400 ml)
~Placebo: 1.5 g / 3 g / 4.5 g / 6 g
~Immediately after admission to hospital, the patient's parameters including blood collection (see below) will be measured for the second time (T2), if applicable, after the end of administration of the study drug. Additional measurements will be made 3 hours (T3), 9 hours (T4), and 24 hours (T5), 48 hours (T6) and one week after admission (T7). 30 days after inclusion in the study, a final investigation is planned (T8)."
16189517|NCT01475331|Drug|Ethanol|Cysts will be lavaged for 3-5 minutes with 80% EtOH
16189518|NCT01475331|Drug|Normal Saline|Cysts will be lavaged for 3-5 minutes with normal saline
16189519|NCT01475331|Drug|Chemotherapy|Following lavage with either 80% ethanol (control group) or normal saline (study group), cysts will be injected with a cocktail of 3mg/ml paclitaxel and 19mg/ml gemcitabine.
16189520|NCT01475318|Drug|mifepristone|200 mg mifepristone on day 1
16189521|NCT01475318|Drug|Letrozole|Letrozole 10mg PO on day 1, day 2, and day 3
16189522|NCT01475318|Drug|Misoprostol|misoprostol 800mcg PV on day 3
16189523|NCT01475305|Drug|Placebo|Participants received single intravenous (IV) dose of placebo matched to MEDI-557 on Day 1 and were inoculated with respiratory syncytial virus (RSV-A) (Memphis-37 strain) as intranasal drops on Day 3.
16189524|NCT01475305|Drug|MEDI-557|Participants received single IV dose of 30 milligram per kilogram (mg/kg) MEDI-557 on Day 1 and were inoculated with RSV-A (Memphis-37 strain) as intranasal drops on Day 3.
16189525|NCT01475292|Drug|RV568|RV568 50 ug administered via a nebuliser once daily for 14 days
16189526|NCT01475292|Drug|RV568|RV568 100 ug administered via a nebuliser once daily for 14 days
16189527|NCT01475292|Drug|Placebo|Placebo administered via a nebuliser once daily for 14 days
16189528|NCT01475279|Drug|Warfarin; Dantonic|Individual warfarin dose during the study; 225mg Dantonic b.i.d for one week
16189529|NCT01475266|Drug|EO9 (Apaziquone)|4 mg/40 mL, Intravesical instillation, Single dose within 6 hours after TURBT
16189530|NCT01475266|Drug|Placebo|40 mL, Intravesical instillation, Single dose within 6 hours after TURBT
16189531|NCT01475253|Drug|Lidocaine Releasing Intravesical System - LiRIS®|Lidocaine Releasing Intravesical System (LiRIS®) is inserted into the bladder via cystoscopy on Study Day 0 and removed on Study Day 14. LiRIS releases lidocaine gradually during the 14 day indwelling period.
16189532|NCT01475253|Other|LiRIS Placebo|LiRIS Placebo contains inactive substance only; LiRIS Placebo is inserted into the bladder via cystoscopy on study Day 0 and removed via cystoscopy on study Day 14.
16189533|NCT01475253|Procedure|Sham Cystoscopy Procedure|Cystoscopy procedure only; no investigational product is inserted/removed from the bladder.
16189534|NCT01475227|Drug|1 Solvazinc tablet, day 2 to day 15|Zinc sulphate 125mg, day 2 to day 15
16189535|NCT01475227|Drug|1 Solvazinc tablet, day 15 to day 28|Zinc sulphate 125mg, day 15 to day 28
16189536|NCT01475214|Dietary Supplement|potassium bicarbonate|potassium bicarbonate in dose of 1.0 mmol/kg per day, given in three even daily doses after meals with a full glass of water
16189537|NCT01475214|Dietary Supplement|potassium bicarbonate|potassium bicarbonate in dose of 1.5 mmol/kg per day, given in three even daily doses after meals with a full glass of water
16189538|NCT01475214|Other|Inactive placebo capsule|microcrystalline cellulose
16189576|NCT01474915|Drug|Ondansetron|Subject will receive 4 mg of Ondansetron IV versus placebo around anesthesia induction
16189871|NCT01472822|Dietary Supplement|Placebo|Placebo 1.2g/day for 12weeks
16189539|NCT01475201|Behavioral|Step count prescription|Treating physicians will provide a pedometer, pedometer log, and step count prescription. The aim is a net increase of at least 3,000 steps/day over one year. The time frame for this increase will be 10 months for sedentary participants (<5,000 steps/day), 7 months for low active participants (5,000-7,499 steps/day), and 5 months for somewhat active participants (7,500-9,999 steps/day). If goals are not met, the doctor and participant will review barriers and facilitators, and a more individualized prescription will be formulated (e.g. lower incremental step count targets or slower rate of dose escalation). For participants who meet goals, the doctor and participant will together decide whether to aim for a further increase.
16189540|NCT01475201|Behavioral|Usual care|The control trial arm will receive usual care alone, over a one-year period (i.e. no step count prescription but, in accordance with guidelines, including advice to engage in 30-60 minutes of activity on most days of the week).
16189541|NCT01475188|Drug|Allergovit|commercially available grass pollen allergoid (100%), concentration A (1000 TU/ml, therapeutic units/ml)concentration B (10000 TU/ml).Patients were given subcutaneous injections with initial dose of 0.1 ml (concentration A) was increased once a 7 (+7) days until the highest tolerated dose (0.6, concentration B) was reached and SIT was continued with injections once every 4 - 6 weeks up to two years.
16189542|NCT01475188|Other|placebo|placebo administered with the same scheme and doses as specific subcutaneous immunotherapy
16189543|NCT01475175|Device|CRT pacing at rest and during exercise|CRT pacing with aCRT settings and BiV pacing with nominal programming at rest and during submaximal exercise
16189544|NCT01475162|Drug|Tocilizumab|Tocilizumab will be administered intravenously at a dose of 8 mg/kg once every three weeks for three doses. After Day 56 doses may be decreased to 4mg/kg once every three weeks depending on GVHD response.
16189545|NCT01475149|Other|Phlebotomy|Subjects will have blood drawn at each of the 3 study visits.
16189546|NCT01475136|Drug|LY2140023|
16189547|NCT01475123|Drug|Nicorandil|15mg per day
16189548|NCT01475110|Drug|Imatinib|Observation of Imatinib resistant patients treated with Nilotinib.
16189549|NCT01475097|Drug|Iodixanol|Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
16189550|NCT01475097|Drug|Iopamidol|Iodixanol 320 mg I/mL given by intra-arterial administration. Comparator agent Isovue (iopamidol) 370 mg I/mL given as intra-arterial administration.
16189551|NCT01475084|Device|cryobiopsy (Autoclavable cryoprobe 20416-032 (ERBE, Germany) Flexible FB-55CD-1 Olympus forceps|"The tip of the cryoprobe will be attached to suspicious part of parietal pleura and activated by footswitch for 3 seconds. The frozen tissue is going to be extracted by gently pulling of the probe. The probe with the attached biopsy sample is going to be removed together with the thoracoscope through trocar. The biopsy sample will be released from the probe by thawing in the saline.
~Forceps biopsy will be performed on usual way."
16189552|NCT01475071|Drug|Metvix and natural daylight PDT|Methyl aminolevulinate, cream 160mg/g.One session at baseline and a second session administration at week 12 for lesions showing non-complete response and new lesions on target area.
16189553|NCT01475071|Drug|Metvix and conventional PDT|Methyl aminolevulinate, cream, 160mg/g. One session at baseline and a second session administration at week 12 for lesions showing non-complete response and new lesions on target area.
16189554|NCT01475058|Biological|allogeneic cytomegalovirus-specific cytotoxic T lymphocytes|Allogeneic CD19-specific chimeric antigen receptor-modified CD8+ central memory derived virus-specific T cells. Allogeneic CD19CAR-TCM cells given IV
16189555|NCT01475032|Drug|CHF 1535|CHF 1535 (BDP/FF) for 12 weeks
16189556|NCT01475032|Drug|Beclomethasone (BDP)|Beclomethasone (BDP) for 12 weeks
16189557|NCT01475032|Drug|Beclomethasone (BDP) + Formoterol Fumarate (FF)|free combo Beclomethasone (BDP) + FF for 12 weeks
16189558|NCT01475019|Drug|Orlistat|Tablet, 120 mg, three times daily, for six months
16189559|NCT01475019|Drug|Sibutramine|Tablet, 10 mg, once daily, for six months
16189560|NCT01475019|Behavioral|Diet and physical exercise|Hypocaloric diet and regular physical exercise
16189561|NCT01475006|Drug|AMG 595|AMG 595 is an antibody drug conjugate that binds to EGFRvIII.
16189562|NCT01474993|Drug|Sulforaphane-rich Broccoli Sprout Extract|"30 subjects will be randomly selected to receive sulforaphane-rich Broccoli Sprout Extract. The medication will be supplied and dispensed as No.1 size gelcaps (each gelcap containing ~ 250 mg sulforaphane rich Broccoli Sprout Extract, equivalent to ~ 50 µmol of sulforaphane). The dosage of sulforaphane will depend on subject's body weight:
~Subjects with body weight less than 101 lbs will receive ~ 50 micromol sulforaphane per day (1 gelcap to be taken once a day)
~Subjects with body weight 101 lbs to 199 lbs will receive ~ 100 micromol sulforaphane per day (2 gelcaps to be taken once a day)
~Subjects with bidy weight > 199 lbs will receive ~ 150 micromol sulforaphane per day (3 gelcaps to be taken once a day)"
16189563|NCT01474993|Drug|Placebo|15 subjects will be randomly selected to receive inactive placebo (Gelcaps identical in appearance to that of active medication and containing microcrystalline cellulose)
16189564|NCT01474967|Drug|Metformin|500 mg metformin daily with breakfast for 1 week 500 mg metformin per 12 hours with breakfast and dinner for 1 week 500 mg metformin with breakfast and 1000 mg with dinner for 22 weeks
16189565|NCT01474967|Drug|Metformin|500 mg metfomin daily with breakfast for 1 week 500 mg metformin per 12 hours with breakfast and dinner for 23 weeks
16189566|NCT01474941|Drug|PF-04620110 or Placebo|Multiple oral doses of 5 mg PF-04620110 as a modified-release formulation or placebo once daily for 2 weeks
16189567|NCT01474941|Drug|PF-04620110 or Placebo|Multiple oral doses of 5 mg PF-04620110 as a modified-release formulation or placebo twice daily for 2 weeks
16189568|NCT01474941|Drug|PF-04620110 or Placebo|Repeat Arm 1 or Arm 2
16189569|NCT01474928|Behavioral|patient role played community video|Group two viewed the patient role played community video
16189570|NCT01474928|Behavioral|both videos group|Group three viewed both the knowledge and community videos
16189571|NCT01474928|Behavioral|Pamphlet group|Group four read an educational pamphlet only
16189572|NCT01474928|Behavioral|physician-led knowledge video|Group one viewed a physician-led knowledge video
16189573|NCT01474928|Behavioral|Community video group|Group two viewed the patient role played community video
16189574|NCT01474928|Behavioral|knowledge video|Group one viewed a physician-led knowledge video
16189672|NCT01474187|Radiation|Radiotherapy|50Gy for whole pelvis
16189577|NCT01474915|Drug|Promethazine|Subject will receive 25 mg of Promethazine IV around anesthesia induction
16189578|NCT01474915|Drug|Dexamethasone|Subject will receive 10 mg of Dexamethasone IV around anesthesia induction
16189579|NCT01474902|Drug|Enoxaparin|Lovenox- Enoxaparin; Sanofi-Aventis Canada Inc.
16189580|NCT01474889|Device|RT-CGM|Each device is approximately the size of a pager and transmits with a subcutaneously placed sensor consisting of a 21 - 26 gauge needle 5 - 12 mm in length. Sensors are placed using sterile precautions and changed every 3 - 7 days depending on the manufacturers' instructions. All devices are approved as adjunctive tools to blood glucose monitoring that will be continued at least 4 times daily, before each meal and at bedtime.
16189581|NCT01474863|Drug|High Dose Citrulline|Initial intravenous bolus of 20mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 9mg/kg (max 700mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days
16189582|NCT01474863|Drug|Placebo|D5W IV fluids at isovolumetric rate (about 15ml/hr)
16189583|NCT01474863|Drug|Low Dose Citrulline|Initial intravenous bolus of 10mg/kg (to a maximum of 1500mg) L-citrulline over 10 minutes. Immediately after the initial bolus, a continuous intravenous infusion of L-citrulline at 4.5mg/kg (max 350mg) per hour will be administered through a dedicated intravenous line or port of a multilumen catheter for 4 days.
16189584|NCT01474850|Procedure|lung recruitment maneuver|RM: peak inspiratory pressure 30 cmH2O, PEEP 15 cm H20 FiO2 0,4 (from end of surgery till extubation)
16189585|NCT01474837|Behavioral|Intervention: Exercise and motivational interviewing|12 sessions of exercise with MI
16189586|NCT01474798|Drug|RA-18C3|"For subjects weighing 27-53 kg: 100 mg (1 ml) administered every three weeks by subcutaneous injection.
~For subjects weighing > 53 kg: 200 mg (2 ml) administered every three weeks by subcutaneous injection."
16189587|NCT01474785|Drug|human ghrelin|0.5-1 pmol/kg.min of human ghrelin administered by IV two times
16189588|NCT01474785|Other|very low calorie diet|standard very low calorie diet that is prescribed for all RYGB patients after their operation
16189589|NCT01474785|Procedure|Hyperinsulinemic/Euglycemic Clamp|Insulin and glucose infusions to measure glucose kinetics.
16189590|NCT01474772|Drug|Pregabalin|150-300 mg/day given in 3 divided doses as capsules
16189591|NCT01474772|Other|placebo|matching placebo capsules given in 3 divided doses
16189592|NCT01474759|Behavioral|Advice on diet, physical activity, and behavior change|Individuals will participate in individual sessions with Registered Dietitians providing basic instruction in principles of weight loss. The program will instruct individuals on the principles of healthy eating and nutrition during calorie restriction. These materials include one module with general information on the importance of limiting portion sizes. The program will also include instruction on physical activity and behavioral strategies for weight loss.
16189593|NCT01474759|Behavioral|Instruction in food portion size|Individuals assigned to this program will participate in individual instructional sessions with specialized materials and tools that address food selection and choosing appropriate portion sizes of various foods.
16189594|NCT01474759|Other|Provision of pre-portioned foods|Individuals assigned to this program will be provided with commercially available pre-portioned foods and will be taught effective ways to incorporate them into their daily diet.
16189595|NCT01474759|Behavioral|Advice on healthy eating for weight loss|Individuals assigned to this program will participate in individual instructional sessions that address principles of healthy eating while on a calorie-restricted diet.
16189596|NCT01474746|Drug|Sertraline|Liquid sertraline (20 mg/mL) will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid sertraline once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid sertraline once per day for a period of six months.
16189597|NCT01474746|Drug|Placebo|The placebo will be dosed in an age-dependent manner. Participants aged 2-3 years of age will be given 2.5 mg (0.125 mL) of liquid placebo once per day for a period of six months. Participants aged 4 years to 5 years 8 months will be given 5 mg (0.25 mL) of liquid placebo once per day for a period of six months.
16189598|NCT01474733|Other|educational intervention|series of lectures and workshops on health literacy
16189599|NCT01474720|Drug|Zostavax vaccine|Commercially available Zostavax vaccine will be administered subcutaneously according to package insert guidelines. Each 0.65-mL dose contains a minimum of 19,400 PFU (plaque-forming units) of Oka/Merck strain of VZV.
16189600|NCT01474707|Behavioral|Group one|Group 1 will view the knowledge-based video only
16189601|NCT01474707|Behavioral|Group two|Group two will view the motivational video only
16189602|NCT01474707|Behavioral|Group three|Group three will view both knowledge-based and motivational videos
16189603|NCT01474707|Behavioral|Group four|Group four will view the printed educational pamphlet and will not view either video
16189604|NCT01474694|Other|Abdominal surgery|The patient is placed in a supine position and standard laparotomy (either via subcostal, midline or inverted hockey-stick incision) is performed. After mobilization of the liver, surgical swabs are packed around the organ to prevent unnecessary movement of the liver during the acquisition of the landmarks and the subsequent surgical procedure
16189605|NCT01474681|Biological|HSC835|
16189606|NCT01474668|Drug|GDC-0941|Single oral dose\n \n\n\n\n
16189607|NCT01474655|Procedure|Pars plana vitrectomy and removal of epiretinal membrane|A three-port standard pars plana vitrectomy was performed by a single surgeon using a 23-gauge vitrectomy system, either Associate®(Dutch Ophthalmic Research Center. Inc., Zuidland, The Netherlands) or Accurus®(Alcon Laboratories Inc., Fort Worth, USA), with one step scleral tunnel incision. Visualization of the fundus was achieved using a wide-angle viewing system. After core vitrectomy, induction of a posterior vitreous detachment was conducted using a 23-gauge angulated dissecting needle in cases without presence of a posterior vitreous detachment. The epiretinal membrane and internal limiting membrane was removed in all eyes. In most cases, internal limiting membrane was removed without the assistance of staining dye. Indocyanine green dye was used to facilitate the removal of internal limiting membrane in some of the cases.
16189608|NCT01474642|Drug|Capecitabine/Cisplatin(XP)|Capecitabine/Cisplatin(XP) D1-D14 Capecitabine 2000mg/m2 D#2 PO D1 Cisplatin 75mg/m2 iv q 3 weeks
16189609|NCT01474642|Drug|Capecitabine/Paditaxel(XG)|Capecitabine/Paditaxel(XG) D1-D14 Capecitabine 2000mg/m2 D#2 PO D1,D8 Paditaxel(genexol) 80mg/m2 iv q 3 weeks
16189610|NCT01474629|Dietary Supplement|probiotic-based dietary supplement|24 trained men receive a probiotic-based dietary supplement for 16 weeks. Dosage 3x 10-9 per day
16189611|NCT01474629|Dietary Supplement|placebo|24 trained men receive a placebo for 16 weeks with same dosage compared to active group
16189612|NCT01474616|Other|Sit-to-Stand Activity|Health care aides will be expected to prompt residents to repeatedly stand up and sit down on four occasions throughout the day (twice on each of the day and evening shifts). The number of repetitions on each occasion will vary according to residents' ability and fatigue. The sit-to-stand activity is to be integrated into usual care routines such as when entering the dining room at mealtimes, while toileting, and on other occasions of regular activity. The timing and location will be at the discretion of the health care aide.
16189613|NCT01474603|Dietary Supplement|n-3 PUFA in protein-enriched low-GI diet|3 g per day n-3 polyunsaturated fatty acids in a protein-enriched low-GI diet
16189614|NCT01474590|Drug|Epiduo/Tactuo|topical to the face, once daily in the evening
16189615|NCT01474590|Other|vehicle gel|topical to the face, once daily in the evening
16189616|NCT01474590|Drug|doxycycline 200mg|oral, 2 capsules once daily in the morning with aglass of water and with food
16189617|NCT01474590|Drug|Isotretinoin|oral, 0.5mg/kg/day for a period of four weeks, adjusted to 1 mg/kg/day for the four following months.
16189618|NCT01474577|Other|questionnaire|Patients will complete one questionnaire over the phone. We will ask patients to describe their cardiac history since Rb-82 PET (chest pain, shortness of breath, cardiac catheterization, and heart attack). This information will be correlated to the scan results and other relevant information in the patient's medical record.
16189619|NCT01474564|Other|Blood draw|Patients with pancreatic adenocarcinoma will be enrolled. Venous blood is collected in a standard 10 ml heparin blood collection tube. We may ask for blood samples at different times during the course of the study, specifically, before you start treatment and when your treatment changes. During the one year of the study, the physician anticipates blood samples will be collected a minimum of one and a maximum of four times. The amount of blood collected at any of these times will be 10 mL, about 1 tablespoon.
16189620|NCT01474551|Drug|vemurafenib|All patients would be treated with vemurafenib given orally at 960 mg twice a day, which was the phase III dose. One cycle is 4 weeks long.
16189621|NCT01474538|Drug|Insulin Lispro|Insulin lispro (100 U/mL) administered by CSII pump
16189622|NCT01474538|Drug|Insulin Aspart|Insulin aspart (100 U/mL) administered by CSII pump
16189623|NCT01474525|Device|Home Blood Glucose Telemonitoring System|"The system is designed to send the measured blood glucose values directly to a hospital server. Values recorded by the glucometer are sent to the Blackberry® cell phone. A special removable Bluetooth® adapter unit is required for data transmission from the glucometer to the Blackberry®. The patient must then select on the Blackberry® the meal period the last measurement corresponds. The cellular phone serves as the platform for data-transmission to the central server. The threshold number of readings can be set for each patient individually through the web-interface. The system can be accessed by both the patients and the care providers through a secure web-interface.
~Apart from collecting values the system generates automated adherence reminders to patients and high/low blood glucose alert messages to both patients and their care providers."
16189624|NCT01474512|Drug|80 mg Ixekizumab Dosing Regimens 1, 2, and 3|Administered SC
16189625|NCT01474512|Drug|Placebo|Administered SC
16189626|NCT01474499|Drug|Glycerine|
16189627|NCT01474499|Drug|Docusate sodium and sorbitol rectal solution|
16189628|NCT01474486|Drug|Micronutrients|Thiamin one tablet daily provides 50 milligrams(mg) of thiamin, Vitamin B-50 one tablet daily: provides an additional 50 mg of thiamin, riboflavin, niacin, pantothenic acid and pyridoxine, 100 microgram(mcg folic acid, and 50 mcg cyanocobalamin (B12) and biotin; Vitamin D one 50,000 International Units(IU) tablet of ergocalciferol per week for two months followed by one tablet every other week for four months, and Zinc Sulfate (Zn SO4) one tablet daily at bedtime which provides 50 mg elemental zinc (220 mg Zn SO4)
16189629|NCT01474473|Device|CACIPLIQ20 and Nonremovable, Windowed, Fiberglass Cast Boot|"The Nonremovable, Windowed, Fiberglass Cast Boot is implemented before the beginning of CACIPLIQ20 treatment and is maintained during the treatment.
~CACIPLIQ20 is applied on the wound for 10 minutes every 3 to 4 days"
16189630|NCT01474473|Device|Placebo and Nonremovable, Windowed, Fiberglass Cast Boot|"The Nonremovable, Windowed, Fiberglass Cast Boot is implemented before the beginning of placebo treatment and is maintained during the treatment.
~Placebo is applied on the wound for 10 minutes every 3 to 4 days"
16189631|NCT01474460|Dietary Supplement|phytonadione|Phytonadione 200mcg PO daily for 6 months + normal dose of warfarin and standard of care treatment
16189632|NCT01474447|Behavioral|Grinberg Method|The GM is a methodology of attention that teaches through expanding and focusing body attention to create a change and an improvement in pain and in quality of life. The method focuses on the way in which we experience pain, and offers an approach that trains people to use their attention and will in order to turn an unwanted experience that causes suffering, into a controlled experience in which they can take responsibility on the way they react to an existing pain. The method uses attention in order to learn the fixed ways in which we respond to pain in our body: where we focus our attention, what is the level of tension in our muscles, how we breathe and relax and more. It gives simple and effective tools to control all these, in order to create optimal conditions in the body to utilize its natural potential to recover and recuperate
16189633|NCT01474434|Drug|pradigastat (LCQ908)|pradigastat tablets were supplied to the investigators at dose strengths of 10 mg and 20 mg as individual patient packs.
16189634|NCT01474434|Drug|Placebo|matching placebo tablets
16189635|NCT01474421|Drug|AQW051|Patients will receive AQW051 in a high dose once daily orally for 28 days.
16189636|NCT01474421|Drug|AQW051|Patients will receive AQW051 in a low dose once daily orally for 28 days.
16189637|NCT01474421|Drug|Placebo|Patients will receive placebo once daily orally for 28 days.
16189638|NCT01474408|Behavioral|interval training day 1|
16189639|NCT01474408|Behavioral|Moderate exercise day 2|
16189640|NCT01474408|Behavioral|Control day 3|
16189673|NCT01474174|Biological|trivalent influenza vaccine|Given IM
16189674|NCT01474174|Other|laboratory biomarker analysis|Correlative studies
16189675|NCT01474161|Drug|GFT505 120mg - old formulation|hard gelatin capsules dosed at 60mg, one single oral administration (Study part I), 6 capsules with 250mL of water.
16189641|NCT01474395|Drug|D-serine|Subjects will then undergo three treatment visits. Each visit will begin with a pre treatment MMN/visual motion paradigm. Subjects will then receive DSR (60 mg/kg) or placebo and begin a one-hour SBR intervention. SBR will begin approximately 30 minutes after drug administration, to coincide with peak serum DSR level. Finally, to evaluate the effects of SBR and NMDA treatment on neurophysiology, subjects will complete a post treatment ERP paradigm. Treatment days will be separated by 1 week to reduce carryover effect. To increase power, each subject will undergo two DSR treatment days and 1 placebo day, with the placebo day selected randomly from among the three treatment days, in counter balanced order. Treatment assignment (drug and SBR) will be double blinded. Follow-up cognitive and safety measures will also be completed on the final treatment day.
16189642|NCT01474395|Drug|placebo|Subjects will then undergo three treatment visits. Each visit will begin with a pre treatment MMN/visual motion paradigm. Subjects will then receive DSR (60 mg/kg) or placebo and begin a one-hour SBR intervention. SBR will begin approximately 30 minutes after drug administration, to coincide with peak serum DSR level. Finally, to evaluate the effects of SBR and NMDA treatment on neurophysiology, subjects will complete a post treatment ERP paradigm. Treatment days will be separated by 1 week to reduce carryover effect. To increase power, each subject will undergo two DSR treatment days and 1 placebo day, with the placebo day selected randomly from among the three treatment days, in counter balanced order. Treatment assignment (drug and SBR) will be double blinded. Follow-up cognitive and safety measures will also be completed on the final treatment day.
16189643|NCT01474395|Behavioral|Sensory Based remediation paradigm|Every subject will receive sensory based remediation on each treatment visit: Three 80-tone pair blocks will be used per session (~1 hour with breaks). To minimize practice effects, we will use a different base tone for each treatment day (e.g. 500, 1000, and 2000 Hz), also in a randomized counter-balanced order. To assess the improvement over a treatment day, we will record the ratio of the frequencies in all tone pairs. To correct this non-normal distribution we take the natural log of each of these ratios to determine the tone matching threshold.
16189644|NCT01474382|Drug|OraVerse|1.8mL dental cartridge delivered in doses of either 1/4, 1/2 or 1 cartridge depending on subject weight
16189645|NCT01474382|Other|Sham injection|No drug administered, simulation of injection used in same manner as drug
16189646|NCT01474369|Drug|TAK-438|TAK-438 10 mg, tablets, orally, once daily for 4 weeks. Thereafter, TAK-438 placebo tablets, orally, once daily for 1 week.
16189647|NCT01474369|Drug|TAK-438|TAK-438 20 mg, tablets, orally, once daily for 4 weeks. Thereafter, TAK-438 placebo tablets, orally, once daily for 1 week.
16189648|NCT01474369|Drug|Placebo|TAK-438 placebo-matching tablets, orally, once daily for 5 weeks.
16189649|NCT01474356|Other|hyperthermia|45 minutes of interstitial heating 42.5-49°C during the interstitial brachytherapy
16189650|NCT01474343|Genetic|SAF-301|The treatment plan consists on a direct injection of the investigational medicinal product SAF-301 to both sides of the brain through 6 image-guided tracks, with 2 deposits per track, in a single neurosurgical session.
16189651|NCT01474330|Drug|Pomalidomide|0.5-mg, 1-mg, or 2-mg capsule administered once daily for 5 days under fasted conditions
16189652|NCT01474330|Drug|Placebo|Placebo capsule
16189653|NCT01474317|Device|G3 Investigational Blood Glucose Monitoring System|Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and AST of the palm using the G3 meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects utilize some additional features of the meter using the User Guide and provide feedback.
16189654|NCT01474304|Drug|Acetaminophen|1000 mg dose intravenous acetaminophen before craniotomy incision and a second 1000 mg dose intravenous acetaminophen 6 hours after surgery
16189655|NCT01474291|Biological|Tocilizumab|Tocilizumab administered according to prescribing information and normal clinical practice.
16189656|NCT01474278|Drug|Placebo|Single dose
16189657|NCT01474278|Drug|RO5028442|Single dose
16189658|NCT01474265|Drug|Varenicline|0.5-2 mg per day, oral use
16189659|NCT01474265|Drug|Placebo|1-2 tablets per day, oral use
16189660|NCT01474265|Drug|Nicorette TX|10-15 mg per day, transdermal use (patches)
16189661|NCT01474252|Drug|RSI|"All medications are administered only one dose before intubation
~Anesthetics:
~Propofol 2-2.5 mg/kg Thiopental 3-5mg/kg Etomidate 1-2mg/kg
~Neuromuscular blocking agents:
~Succinylcholine 1-1.5mg/kg Rocuronium 0.9mg/kg
~Opioid:
~Fentanyl 1-2ug/kg"
16189662|NCT01474239|Drug|bevacizumab [Avastin]|10 mg/kg every 2 weeks intravenously until disease progression or unacceptable toxicity
16189663|NCT01474239|Drug|fotemustine|75 mg/m2 intravenously on days 1, 8 and 15 followed by, after a 5 weeks interval, 100 mg/m2 on day 1 of a 3-weeks cycle. Until disease progression or unacceptable toxicity
16189664|NCT01474226|Dietary Supplement|Amino Acid Crystalline Lysine Amino Acid Mix|crystalline lysine from AA MIX (20, 40, and 60% of the mean lysine requirement of 35 mg/kg/d) Lysine will be given in the form of L-Lysine-HCl, Sigma-Aldrich Brand.
16189665|NCT01474226|Dietary Supplement|Cooked Rice containing Lysine|Lysine (20,40 and 60 % of the mean lysine requirement) from Cooked Rice
16189666|NCT01474213|Drug|dexmedetomidine group|1-1.5cmg/kg dexmedetomidine infusion within 10 minutes, while followed by maintainly infusing 0.7cmg/kg/min dexmedetomidine
16189667|NCT01474213|Drug|remifentanil group|target controlled 3.5-4ng/ml remifentanil infused(blood plasma concentration)
16189668|NCT01474200|Device|Isolated veno-venous ultrafiltration (AQ)|Aquapheresis treatment (isolated veno-venous ultrafiltration) using the Aquadex FlexFlow System during index hospitalization until the patient's signs and symptoms of fluid overload have improved to the satisfaction of the treating physician. Ultrafiltration rates, duration and frequency of treatment are dependent on the amount of patient fluid excess and on the rate of fluid movement from the interstitial spaces into the vascular compartment during Aquapheresis (Plasma Refill Rate, or PRR)
16189669|NCT01474200|Drug|IV Loop Diuretics (LD)|"IV Loop Diuretics treatment using only FDA approved IV loop diuretics indicated for the treatment of patients with fluid overload. This includes furosemide or other IV loop diuretics administered at equivalent doses to furosemide. Patients will receive either a twice daily IV bolus or continuous IV LD infusions according to the high dose protocol of theDiuretic strategies in patients wth acute decompensated heart failure (DOSE) trial."
16189670|NCT01474187|Drug|Irinotecan|initial from 50mg/m2/week and increased by 15mg/m2/week
16189671|NCT01474187|Drug|Capecitabine|625mg/m2,bid,d1-5,qw
16189676|NCT01474161|Drug|GFT505 120mg - new formulation|hard gelatin capsules dosed at 60mg, one single oral administration (Study Part I) or multiple dose administration from Day 1 to Day 14 (Study Part III and IV), 2 capsules with 250mL of water.
16189677|NCT01474161|Drug|GFT505 180mg - new formulation|hard gelatin capsules dosed at 60mg, one single oral administration (Study Part II) or multiple dose administration from Day 1 to Day 14 (Study Part III and IV), 3 capsules with 250mL of water.
16189678|NCT01474161|Drug|GFT505 240mg - new formulation|hard gelatin capsules dosed at 60mg, one single oral administration (Study Part II) or multiple dose administration from Day 1 to Day 14 (Study Part III), 4 capsules with 250mL of water.
16189679|NCT01474161|Drug|GFT505 300mg - new formulation|hard gelatin capsules dosed at 60mg, one single oral administration (Study Part II), 5 capsules with 250mL of water.
16189680|NCT01474161|Drug|Placebo|hard gelatin capsules, one single oral administration (3 to 5 capsules with 250mL of water for Study Part II) or multiple dose administration from Day 1 to Day 14 (2 to 4 capsules with 250mL of water for Study Part III).
16189681|NCT01474148|Device|IRS-8 (8-Channel implanted stimulator-telemeter)|Surgical implantation of the 8-channel neuroprosthesis
16189682|NCT01474135|Drug|0.25% AR-12286 / 0.004% travoprost|
16189683|NCT01474135|Drug|0.5% AR-12286, 0.004% travoprost|
16189684|NCT01474135|Drug|0.004% Travoprost|
16189685|NCT01474122|Drug|Macitentan 3 mg|Macitentan 3-mg tablet once daily
16189686|NCT01474122|Drug|Macitentan 10 mg|Macitentan 10-mg tablet once daily
16189687|NCT01474122|Drug|Placebo|Placebo tablet matching macitentan tablet, once daily
16189688|NCT01474109|Drug|macitentan 3mg|macitentan 3mg tablet once daily
16189689|NCT01474109|Drug|macitentan 10mg|macitentan 10mg tablet once daily
16189690|NCT01474109|Drug|placebo|matching placebo once daily
16189691|NCT01474096|Other|implementation strategy of Breastfeeding|implementation strategy (including training session, information distribution, an opinion leader) of Breastfeeding
16189692|NCT01474083|Drug|GK1-399 (formerly TTP399)|Treatment A: GK1-399 200 mg. Oral administration, twice per day.
16189693|NCT01474083|Drug|GK1-399 (formerly TTP399)|Treatment B: GK1-399 800 mg. Oral administration, once per day.
16189694|NCT01474083|Drug|GK1-399 (formerly TTP399)|Treatment C: GK1-399 800 mg. Oral administration, twice per day.
16189695|NCT01474083|Drug|Placebo|Dose-matched placebo. Oral administration.
16189696|NCT01474070|Device|Intraocular Pressure Measurement|Intraocular pressure is measured with GAT and with DCT
16189697|NCT01474057|Behavioral|DESTRESS-PC|"An online nurse-assisted, self-management intervention designed for primary care treatment of war-related PTSD, this intervention will consist of 3 weekly logins to a secure website for a period of 6 weeks. A DESTRESS Nurse will train the participant to use the website and will monitor their progress and report key information back to the primary care physician."
16189698|NCT01474057|Other|Optimized Usual Primary Care PTSD treatment|Participants receive usual Primary Care treatment that is administered by the primary care physician; the DESTRESS Nurse monitors the participants' progress throughout the study.
16189699|NCT01474044|Drug|Gastropylor Complex Capsules|3 pills, three times a day, after meal
16189700|NCT01474044|Other|Placebo Comparator|Placebo that is same as gastropyloric complex capsules
16189701|NCT01474031|Other|Biomechanics|"Time interval: pre-op - 3m - 6m - 12m
~Assessment of all subjects:
~XR
~Gait analysis with surface EMG and trunk markers:
~Unipodal standing: 3 trials Right and 3 trials Left on FP
~Level walking: 3 trials Right and 3 trials Left on FP
~Chair rise: 3 trials, both legs on FP
~Stair ascent: 3 trials Right and 3 trials Left on first FP
~Stair descent: 3 trials Right and 3 trials Left on first FP
~Squat: 3 trials, both legs on FP
~Bipodal squat: 3 trials Right and 3 trials Left on FP
~Functional scores (HHS, UCLA, HOOS, SF-36)"
16189702|NCT01474018|Drug|QR-bromocriptine|The study drug is added-on to patients on existing type 2 diabetes treatment with insulin +metformin+exercise/nutritional counseling. The study drug is titrated up starting at one 0.8mg tab daily for 1 week, then 2 (0.8mg) tablets for week 2, then 3 tablets for week 3, then 4 tablets for week 4, then 5 tablets for week 5, then six tablets for week 6 (total 4.8). The limiting factor is nausea at which point the patients will back down the highest tolerated dose and continue on that dose for the remainder of the 6 months of the study.
16189703|NCT01474005|Device|PROTIP MEDICAL ( Artificial larynx prosthesis)|establishment of an artificial larynx prosthesis
16189704|NCT01473992|Device|Otto Bock C-Leg|Amputees' preferred prosthetic knee.
16189705|NCT01473992|Device|Otto Bock Genium|Study knee.
16189706|NCT01473979|Procedure|Surgical closure of the poststernotomy wound infection|"Arm A) Secondary closure with the vacuum-assisted system (VAC); The initial surgical revision is done within 24 hours. The first revision with second look and debridement is usually made in 72 hours Subsequently in the following days the wound is stepwise revised during VAC changes.The patients are obtained 5 to 7 times to the surgical procedures in time intervals of 72 hours. Subsequently when the last three bacteriology samples are negative a delayed primary closure or rectus abdominal muscle flap may be done.
~Arm B) Surgical procedure by delayed primary closure; The patients will receive treatment delivered through the VAC system in the first 48 hours following the first surgical intervention, subsequently the wound is closed. after the sternum is closed by using metallic wires, pectoral muscle on both chest parts is mobilized and closed directly over the bone."
16189707|NCT01473966|Dietary Supplement|coffee|patients will receive a cup of coffee at room temperature orally twice daily
16189708|NCT01473966|Dietary Supplement|coffee rectally|patients receive an enema of two cups of coffee at room temperature once daily
16189709|NCT01473953|Drug|liraglutide-depot|Subjects will be randomised to receive a single dose of liraglutide-depot, at increasing dose levels, injected s.c./subcutaneously (under the skin). Progression to next dose level (max. 8) will be based on safety evaluation.
16189710|NCT01473953|Drug|placebo|Subjects will be randomised to receive a single dose of liraglutide-depot placebo, at increasing dose levels, injected s.c./subcutaneously (under the skin).
16189711|NCT01473940|Biological|ipilimumab|Given IV
16189712|NCT01473940|Drug|gemcitabine hydrochloride|Given IV
16189713|NCT01473940|Other|laboratory biomarker analysis|Correlative studies
16189814|NCT01473238|Other|Evaluation form|A validated user experience evaluation questionnaire will be completed by each participant in the beginning, at the interim period, and at the end of the trial
16193663|NCT01444248|Drug|Glimepiride/ Metformin|4/1000mg once daily
16189714|NCT01473927|Other|Endoscopy|Only patients undergoing endoscopy for clinical reasons will be included in the study, i.e. no endoscopies will be performed solely for study reasons. For the purposes of our study, endoscopy serves to determine the degree of inflammation and no additional biopsies are taken. Blood for CRP and ficolin-2 analysis will be taken through the Venflon® installed for endoscopy.
16189715|NCT01473927|Other|Endoscopy|Only patients undergoing endoscopy for clinical reasons will be included in the study, i.e. no endoscopies will be performed solely for study reasons. For the purposes of our study, endoscopy serves to determine the degree of inflammation and no additional biopsies are taken. Blood for CRP and ficolin-2 analysis will be taken through the Venflon® installed for endoscopy.
16189716|NCT01473914|Dietary Supplement|Low dose: supplemental zinc, selenium and vitamin E|"ZINC 25mg (AS ZINC SULFATE)
~SELENIUM 50 mcg (AS SODIUM SELENITE)
~VITAMIN E (D-ALPHA-TOCOPHEROL) (AS SUCCINATE) 250 IU"
16189717|NCT01473914|Dietary Supplement|Standard renal vitamin: B and C renal vitamin|"BIOTIN 300 MCG
~D-PANTOTHENIC ACID (CALCIUM D-PANTOTHENATE) 10 MG
~FOLIC ACID 1 MG
~NIACINAMIDE 20 MG
~VITAMIN B1 (THIAMINE MONONITRATE) 1.5 MG
~VITAMIN B12(CYANOCOBALAMIN) 6 MCG
~VITAMIN B2 (RIBOFLAVIN) 1.7 MG
~VITAMIN B6 (PYRIDOXINE HYDROCHLORIDE) 10 MG
~VITAMIN C (ASCORBIC ACID) 100 MG
~INERT FILLER (CORNSTARCH)"
16189718|NCT01473914|Dietary Supplement|Medium dose: supplemental zinc, selenium and vitamin E|"ZINC 50 mg (AS ZINC SULFATE)
~SELENIUM 75 mcg (AS SODIUM SELENITE)
~VITAMIN E (D-ALPHA-TOCOPHEROL) (AS SUCCINATE) 250 IU"
16189719|NCT01473901|Drug|BKM120 + temozolomide|The investigational drug, BKM120, will be supplied as 10-mg and 50-mg hard gelatin capsules. BKM120 will be administered on a once daily dosing schedule at a dose of 40 mg, or 60 mg, or 80 mg, or 100 mg (p.o.), in combination with the approved dosing of temozolomide and SoC delivery of cranial irradiation for GBM. The patient will be dosed with BKM120 on a flat scale of mg/day and the dose of BKM120 will not be adjusted to body weight or body surface area. Patients should not eat for 2 hours after the administration of BKM120. Temozolomide in 5 mg, 20 mg, 100 mg, 140 mg, 180 mg or 250 mg capsules will be administered in combination with the investigational drug BKM120.
16189720|NCT01473901|Drug|BKM120 +temozolomide with/without radiotherapy|The investigational drug, BKM120, will be supplied as 10-mg and 50-mg hard gelatin capsules. BKM120 will be administered on a continuous once daily dosing schedule at a dose of 40 mg, or 60 mg, or 80 mg, or 100 mg (p.o.), in combination with the approved dosing of temozolomide and SoC delivery of cranial irradiation for GBM. The patient will be dosed with BKM120 on a flat scale of mg/day and the dose of BKM120 will not be adjusted to body weight or body surface area. Patients should not eat for 2 hours after the administration of BKM120. Temozolomide in 5 mg, 20 mg, 100 mg, 140 mg, 180 mg or 250 mg capsules will be administered in combination with the investigational drug BKM120.
16189721|NCT01473888|Drug|T89(Dantonic)|capsule, 225mg B.I.D.
16189722|NCT01473836|Drug|Metronidazole|Metronidazole will be administered at a dose of 500 mg TID (or QID for refractory or severe infection) for 3 to 14 days, in principle. Treatment duration can be prolonged up to 21 days based on subject's condition.
16189723|NCT01473836|Drug|Ceftriaxone sodium|Ceftriaxone sodium will be administered at a daily dose of 2 g (strength) when metronidazole is administered TID or at a daily dose of 4 g (strength) when metronidazole is administered QID.
16189724|NCT01473823|Dietary Supplement|Omega-3 LCPUFA|Dosage is 5 ml daily until age 3 years.
16189725|NCT01473810|Biological|Vacc-4x low dose|80 µg Vacc-4x (20 µg pr. peptide) in 300 µl Endocine divided into two administrations, one for each nose cavity, administrated once weekly for four weeks
16189726|NCT01473810|Biological|Vacc-4x medium dose|400 µg Vacc-4x (100 µg pr. peptide) in 300 µl Endocine divided into two administrations, one for each nose cavity, administrated once weekly for four weeks
16189727|NCT01473810|Biological|Vacc-4x high dose|1200 µg Vacc-4x (300 µg pr. peptide) in 300 µl Endocine divided into two administrations, one for each nose cavity, administrated once weekly for four weeks
16189728|NCT01473810|Biological|Zero dose|300 µl Endocine divided into two administrations, one for each nose cavity, administrated once weekly for four weeks
16189729|NCT01473797|Drug|Cladribine|Subcutaneous injections, 0,1 mg/kg/day for 5 days, one course per month for 4 months
16189730|NCT01473784|Procedure|transoral robotic surgery|Undergo TORS using the Da Vinci Robotic Surgical System
16189731|NCT01473784|Procedure|quality of life assessment|After surgery regular clinical assessments will be scheduled to see how the patient is doing. Patients will be asked to answer a quality of life assessment as part of the study. If patients are unable to come to the Ohio State University Medical Center for a physician appointment they will be contacted via phone or mailed a questionnaire to complete.
16189732|NCT01473771|Behavioral|Caring Letter (email)|"Participants will be emailed letters for two years. The first letter will be sent one week afer discharge from the inpatient psychiatric unit. There will be four subsequent email letters sent every month starting from the day of discharge, then another four every two months. The last four email letters will be sent every three months for the remainder of the two year period."
16189733|NCT01473758|Drug|Roflumilast|500 µg tablet, od, oral administration in the morning after breakfast
16189734|NCT01473758|Drug|Placebo|tablet, od, oral administration in the morning after breakfast
16189735|NCT01473745|Procedure|conventional alar base cinch|The conventional suture began from the bilateral alar part of the nasalis muscle and passed through a hole drilled on the anterior nasal spine.
16189736|NCT01473745|Procedure|modified alar base cinch|The modified suture began from the bilateral alar part of the nasalis muscle and dermis tissue over the alar base, and then passed through a hole drilled on the anterior nasal spine.
16189737|NCT01473732|Drug|Everolimus|Starting dose 1.5 mg bid, target trough level 6-10 ng/ml.
16189738|NCT01473732|Drug|Tacrolimus|Target trough level of Tacrolimus 3-5 ng/ml.
16189739|NCT01473732|Drug|Mycophenolic acid|Myfortic Min. dose 360 mg bid and Max dose 720 mg bid. Used in both arms. Used for one year.
16189740|NCT01473719|Behavioral|motivational intervention|7-session individual motivationally-based intervention
16189741|NCT01473719|Behavioral|health education|7 individual sessions focusing on health education
16189742|NCT01473706|Other|Consumer Mini Nutritional Assessment|A 11 question, self administered nutrition screening tool. The consumer and their caregiver will complete the consumer version of the Mini Nutritional Assessment. A healthcare professional will then meet with the consumer and complete a nutrition screening with utilizing a validated nutrition screening tool.
16193664|NCT01444248|Drug|Glimepiride/ Metformin|4/1000mg bid
16189743|NCT01473693|Other|MRI Screening Form, MRI, Demographic / Medical Data form|"MRI Screening Form: MRI screening form will be administered twice at baseline and follow up visits. Administration time: 5 minutes. MRI data: at both time points (pre- and post-treatment only) Administration time: 30 minutes.
~Demographic / Medical Data: Administration time: 5 minutes."
16189744|NCT01473693|Other|MRI Screening Form, MRI. Demographic / Medical Data|"MRI Screening Form: MRI screening form will be administered twice at baseline and follow up visits Administration time: 5 minutes.
~MRI data: at both time points (pre- and post-treatment only) Administration time: 30 minutes.
~Demographic / Medical Data: Administration time: 5 minutes"
16189745|NCT01473680|Other|EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical Questionnaire|Participants will complete a medical/psychiatric history questionnaire, and a standardized battery of neuropsychological (NP) tests and psychological instruments. EEG recording will be made as participants engage in tasks of basic perceptual or pre-attentive processes and selective attention. Following chemotherapy (and a matched interval for the no-chemotherapy and healthy control groups), the standardized battery of NP tests, psychological instruments, and EEG will be repeated.
16189746|NCT01473680|Other|EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical Questionnaire|Participants will complete a medical/psychiatric history questionnaire, and a standardized battery of neuropsychological (NP) tests and psychological instruments. EEG recording will be made as participants engage in tasks of basic perceptual or pre-attentive processes and selective attention. Following chemotherapy (and a matched interval for the no-chemotherapy and healthy control groups), the standardized battery of NP tests, psychological instruments, and EEG will be repeated.
16189747|NCT01473680|Other|EEG, Neuropsychological Evaluation, Psychological Questionnaires, Medical Questionnaire|Participants will complete a medical/psychiatric history questionnaire, and a standardized battery of neuropsychological (NP) tests and psychological instruments. EEG recording will be made as participants engage in tasks of basic perceptual or pre-attentive processes and selective attention. Following chemotherapy (and a matched interval for the no-chemotherapy and healthy control groups), the standardized battery of NP tests, psychological instruments, and EEG will be repeated.
16189748|NCT01473667|Procedure|Superficial Cervical Plexus Block (SCP) block|SCP block using 10-15ml of 1% Ropivacaine
16189749|NCT01473667|Procedure|Local site infiltration|Local site infiltration using 2% lidocaine
16189750|NCT01473654|Behavioral|ADAPT tool|Use of ADAPT shared goal setting tool in EMR
16189751|NCT01473628|Other|Clinical Observation|Undergo observation
16189752|NCT01473628|Radiation|Radiation Therapy|Undergo radiation therapy
16189753|NCT01473628|Biological|Rituximab|Given IV
16189754|NCT01473615|Behavioral|Mindfulness Based Cognitive Therapy|A manualized 8-week MBCT group skills program with weekly sessions that each last 2 hours. The MBCT sessions combine elements of cognitive therapy with a mindful approach to thoughts and feelings, including a significant meditation component. The program is specifically tailored to a population that suffers from active depressive symptoms and chronic pain. The program also includes daily homework exercises.
16189755|NCT01473602|Drug|Teriparatide|Administered by SC injection
16189756|NCT01473602|Drug|Placebo|Administered by SC injection
16189757|NCT01473602|Dietary Supplement|Calcium supplementation|Administered orally
16189758|NCT01473602|Dietary Supplement|Vitamin D supplementation|Administered orally
16189759|NCT01473589|Drug|Teriparatide|Administered by SC injection
16189760|NCT01473589|Drug|Placebo|Administered by SC injection
16189761|NCT01473589|Dietary Supplement|Calcium supplementation|Administered orally
16189762|NCT01473589|Dietary Supplement|Vitamin D supplementation|Administered orally
16189763|NCT01473576|Dietary Supplement|Nitrate|0.15 mmol/kg body weight sodium nitrate (dissolved in 250 mL water)
16189764|NCT01473576|Dietary Supplement|Sodium chloride|0.15 mmol sodium chloride dissolved in 250 mL water.
16189765|NCT01473563|Drug|Pemetrexed|Administered intravenously
16189766|NCT01473550|Behavioral|Access to TELUS Health Space and Smart Phone|Participants will be given their own TELUS Health Space and Smart Phone in order to have access to their personal health records. Specific procedures using the smart phone will depend on the individual care plan for each participant. Prompts and assessments will vary depending on participant needs.
16189767|NCT01473537|Drug|calcium lactate solution|Calcium lactate solution 75 mM, 150 mM, 175 mM and placebo
16189768|NCT01473524|Drug|Obeticholic Acid (OCA)|OCA was administered orally once daily and provided in tablet form in 2 strengths: 5 mg and 10 mg.
16189769|NCT01473524|Drug|Placebo|Matching placebo tablets were administered orally once daily.
16189770|NCT01473511|Behavioral|Strongest Families Intervention (formerly Family Help)|Distance HEALTH education intervention focussed on skill learning for parents
16189771|NCT01473498|Other|Haemodynamic management|"Patients will be treated with fluid and norepinephrine to achieve and maintain a mean arterial pressure of 65 mm Hg. Then they will be randomized in two groups.
~In the first group (study group, n=30), mean arterial pressure will be increased to 85 mm Hg for 72 hours by increasing the dose of norepinephrine in patients."
16189772|NCT01473498|Other|Haemodynamic management|"Patients will be treated with fluid and norepinephrine to achieve and maintain a mean arterial pressure of 65 mm Hg. Then they will be randomized in two groups.
~In this group (control group, n=30), mean arterial pressure will be maintained at 65 mm Hg."
16189773|NCT01473485|Device|ExAblate Transcranial System|MR Guided Focused Ultrasound
16189774|NCT01473472|Drug|Truvada|2 tablets of truvada within 24 hours before first sexual relations, then 1 tablet of Truvada during the period of sexual activity including the last sexual intercourse, finally, a last dose of 1 tablet of Truvada approximately 24 hours later
16189775|NCT01473472|Drug|Placebo|2 tablets of placebo within 24 hours before first sexual relations, then 1 tablet of placebo every 24 hours during the period of sexual activity including the last sexual intercourse, finally, a last dose of 1 tablet of placebo approximatively 24 hours later
16189776|NCT01473459|Procedure|IVM (In Vitro Maturation) Treatment|There will be no gonadotropin stimulation. There will be ovum pickup from antral follicles of immature oocyte which will be matured in the lab and fertilized by intracytoplasmic sperm injection (ICSI). Embryo transfer will take place on days 2 or 3.
16189815|NCT01473225|Other|Calorie information|Nutrition label featuring calorie information will be provided.
16189816|NCT01473225|Other|No calorie information|No nutrition label will be provided in this condition.
16189777|NCT01473459|Procedure|IVF (In Vitro Fertilization) Antagonist Protocol|The first stage of the treatment will be stimulation with gonadotropins. Next GNRH Antagonist will be added. Ovulation induction will be performed with GNRH agonist. After ovulation there will be ovum pickup and fertilization in the lab. Embryo transfer will take place on days 2 or 3.
16189778|NCT01473446|Procedure|Goal directed fluid therapy guided by LiDCOrapid|"Standard monitoring. The patient is connected to the LiDCOrapid monitor via an arterial line placed in a.radialis. A bolus of 500 ml Ringer acetate is given before anesthesia. If the stroke volume (SV) increases more than 10%, repeat the procedure until the SV is not increasing. After that, induction of anesthesia.
~Maintenance fluid is given as Ringer acetate 2ml/kg/t. Continuous monitoring of stroke volume variation (SVV). If SVV> 10%, give a fluid bolus 6ml/kg Ringer acetate. Repeat until SVV <10%. Bleeding is being replaced 1:1 with hydroxyethyl starch. SAG by bleeding >1000ml. By fall in blood pressure and SVV <10%, start vasoactive treatment with epinephrine. Postoperative is given Glucose 5% 80ml/h."
16189779|NCT01473433|Procedure|Pericardial adipose pedicle (adiFLAP) transposition.|Patients with a established transmural necrosis, candidates for revascularization of other myocardial areas, will be enrolled. The non-revascularizable area will be covered by the adiFLAP and the revascularizable area will be treated with the normal procedure. A non-revascularizable area will be considered whenever a transmural necrosis is detected by means of gadolinium contrast using MRI.
16189780|NCT01473433|Other|Control|Patients with a established transmural necrosis, candidates for revascularization of other myocardial areas, will be enrolled. The non-revascularizable area will be left untouched and the revascularizable area will be treated normally (by-pass).
16189781|NCT01473420|Biological|Epoetin Hospira|Variable dose
16189782|NCT01473420|Biological|Epogen Amgen|Variable dose
16189783|NCT01473407|Biological|Epoetin Hospira|Variable dose
16189784|NCT01473407|Biological|Epogen (Amgen)|Variable dose
16189785|NCT01473394|Drug|Dose-matched placebo|Dose-matched placebo was supplied as tablets.
16189786|NCT01473394|Drug|Vilazodone|Vilazodone was supplied as tablets.
16189787|NCT01473381|Drug|Vilazodone|Vilazodone was supplied as film-coated tablets.
16189788|NCT01473381|Drug|Placebo to citalopram|Placebo to citalopram was supplied as a capsule.
16189789|NCT01473381|Drug|Placebo to vilazodone|Placebo to vilazodone was supplied as film-coated tablets.
16189790|NCT01473381|Drug|Citalopram|Citalopram was supplied as encapsulated tablets.
16189791|NCT01473368|Dietary Supplement|Saccharomyces boulardii|500 mg, 2 times daily for 14 days
16189792|NCT01473368|Drug|Amoxicillin Clavulanate|875/125 mg 2 times daily at least 1 hour before meals for 7 days
16189793|NCT01473355|Device|OsseoSpeed™ TX|OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm
16189794|NCT01473342|Behavioral|Mila Blooms|Behavioral intervention will be administered to 30 adolescent childhood cancer survivors & their parents (3 blocks of 10 survivor-parent(s) groups) who serve as their own controls. The intervention phase begins at Week 9 (immediately following the 8-week control phase) and runs for 9 weeks (Weeks 9 - 17). Adolescents are assigned a smartphone installed with the Mila Blooms app to use for the first 8 weeks (Weeks 9 - 16) of the intervention. The app integrates (1) tools for tracking health behaviors (e.g., diet, physical activity, etc.); (2) an avatar system to provide virtual rewards, and (3) a social network of users for support. As part of the intervention, adolescents will also receive weekly coaching phone calls from study staff to discuss areas of concern and to encourage goal-setting & participation. During the 9th week (Week 17), participants complete one final survey & accelerometer wear.
16189795|NCT01473329|Other|Structured Diabetes Education|The intervention group received a structured DSME course adapted from 15. The course was composed by weekly 2 hour meetings for five weeks total hours group of 10 patient and reinforcement meetings every 4 months, for one year
16189796|NCT01473316|Drug|GDC-0980|Single oral dose
16189797|NCT01473316|Drug|Ketoconazole|Repeating Oral Dose
16189798|NCT01473303|Biological|ganitumab|Given IV
16189799|NCT01473303|Drug|fluorouracil|Given IV
16189800|NCT01473303|Drug|irinotecan hydrochloride|Given IV
16189801|NCT01473303|Drug|leucovorin calcium|Given IV
16189802|NCT01473303|Drug|oxaliplatin|Given IV
16189803|NCT01473303|Other|placebo|Given IV
16189804|NCT01473303|Other|questionnaire administration|Completed on paper
16189805|NCT01473290|Dietary Supplement|live freeze-dried lactic acid bacteria probiotic|Given orally (PO)
16189806|NCT01473290|Other|placebo|Given PO
16189807|NCT01473277|Drug|BT-A (Dysport 500U), Triamcinolone acetonide|"All patients will be randomize to receive an intra-articular injection of BT-A (Dysport 500U) or triamcinolone acetonide (40 mg). Both drugs will be reconstituted with 2.0 ml of saline. Both drugs will be injected in the glenohumeral joint with a standard posterior approach. The time of the intra-articular injection od BT-A or steroid will be considered the time zero for each patient. The primary and secondary efficacy variables will be evaluated in all patients at 1 week, 2 weeks, 4 weeks, 3 months and 6 months after the treatment."
16189808|NCT01473264|Drug|recombinant human CC10 (rhCC10)|5 mg/kg rhCC10, single dose delivered intratracheally (IT). Treatment was delivered within four hours after surfactant treatment. Dose was delivered IT in two (2) equal aliquots via a premeasured feeding tube placed in the distal third of the endotracheal tube with the patient in the right and then left lateral decubitus position and 30 degrees of Trendelenburg.
16189809|NCT01473264|Drug|recombinant human CC10 (rhCC10)|1.5 mg/kg rhCC10, single dose delivered intratracheally (IT). Treatment was delivered within four hours after surfactant treatment. Dose was delivered IT in two (2) equal aliquots via a premeasured feeding tube placed in the distal third of the endotracheal tube with the patient in the right and then left lateral decubitus position and 30 degrees of Trendelenburg
16189810|NCT01473264|Drug|placebo|Half normal saline solution; single dose delivered intratracheally (IT). Treatment was delivered within four hours after surfactant treatment. Dose was delivered IT in two (2) equal aliquots via a premeasured feeding tube placed in the distal third of the endotracheal tube with the patient in the right and then left lateral decubitus position and 30 degrees of Trendelenburg.
16189811|NCT01473251|Drug|Avastin|1.25 mg monthly for 4 months
16189812|NCT01473251|Drug|Avastin|1.25 mg monthly for 4 months
16189813|NCT01473251|Drug|Lucentis|0.5 mg monthly for 4 months
16189868|NCT01472835|Drug|Midazolam|Used for anxiolysis
16189817|NCT01473199|Device|BioPoly RS Partial Resurfacing Knee Implant|A long term, surgically invasive device for replacement of focal osteochondral defects in the weight bearing region of the femoral condyles.
16189818|NCT01473173|Drug|CJ-12420|
16189819|NCT01473173|Drug|Esomeprazole 40mg|
16189820|NCT01473160|Device|delefilcon A contact lens|CE-marked, silicone hydrogel, single vision, soft contact lens for daily disposable wear
16189821|NCT01473160|Device|narafilcon A contact lens|Commercially marketed, silicone hydrogel, single vision, soft contact lens for daily disposable wear.
16189822|NCT01473147|Drug|Exenatide|Exenatide 5 microgram bid sc.
16189823|NCT01473147|Drug|Normal saline|Normal saline 2 u bid sc.
16189824|NCT01473121|Other|No Intervention|All treatment options (inc. surgery, TACE, drugs) will be registered.
16189825|NCT01473108|Drug|Finerenone (BAY 94-8862) PEG solution|2.5, 5, 10, 20 mg polyethylene glycol (PEG) solution of BAY 94-8862
16189826|NCT01473108|Drug|Finerenone (BAY 94-8862) immediate release tablet|20 mg BAY 94-8862 administered as 2 x 10 mg IR tablets
16189827|NCT01473108|Drug|Eplerenone (Inspra®)|Single oral dose of 50 mg eplerenone
16189828|NCT01473108|Drug|Placebo|Matching placebo (solution/tablet) corresponding to BAY 94-8862 dose in respective dose step
16189829|NCT01473095|Drug|ARQ 092|Subjects in this study will receive ARQ 092 orally at dose levels specified for their respective dose cohorts. Dosing will begin at 10 mg every other day (QOD) and will escalate until the MTD or RP2D is determined. Cycles will be repeated in four-week (28 day) intervals until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, dose adjustment will be permitted.
16189830|NCT01473082|Device|PFNA Augmentation (Synthes)|Proximal Femoral Nail Antirotation (PFNA) Augmentation (with Traumacem V+)
16189831|NCT01473082|Device|PFNA (Synthes)|Proximal Femoral Nail Antirotation (PFNA)
16189832|NCT01473069|Drug|JTK-853, ketoconazole|JTK-853 Tablets or Placebo, twice a day for 14 days, JTK-853 and ketoconazole Tablets, 1 each on Day 15
16189833|NCT01473069|Drug|JTK-853 or Placebo|JTK-853 Tablets or Placebo, twice a day for 14 days
16189834|NCT01473056|Drug|JTK-853|Tablets, twice a day for 3 days
16189835|NCT01473056|Drug|Dose 2 JTK-853|Tablets, twice a day for 3 days
16189836|NCT01473056|Drug|Dose 3 JTK-853|Tablets, three times a day for 3 days
16189837|NCT01473056|Drug|Dose 4 JTK-853|Tablets, twice a day for 3 days
16189838|NCT01473056|Drug|Placebo|Tablets, twice a day or three times a day for 3 days
16189839|NCT01473043|Drug|Axitinib|5mg twice daily [BD] daily dosing until progression or prohibitive toxicity Dose titration by 2 levels upwards (7mg and 10mg) and downwards (3mg and 2mg) allowed per protocol
16189840|NCT01473017|Behavioral|CBT-based Guided Self-Help|CBT-based booklet tailored to anxiety and/or depression in Type 2 Diabetes to enhance mood and Diabetes self-care
16189841|NCT01473004|Device|Sir-Spheres®|Sir-Spheres® Yttrium-90 microspheres given intra-hepatic; once for each lobe involved separated by 4 weeks.
16189842|NCT01472991|Drug|TC-5619-238 5mg|TC-5619-238 5mg capsule taken once daily for 4 weeks
16189843|NCT01472991|Drug|TC-5619-238 25mg|TC-5619-238 25mg capsules taken once daily for 4 weeks
16189844|NCT01472991|Drug|Placebo|Placebo capsules will be taken once daily for 4 weeks
16189845|NCT01472978|Drug|metronidazole|Metronidazole, 500 mg three times a for 10 days
16189846|NCT01472965|Drug|ethanol|70% ethanol catheter lock therapy
16189847|NCT01472965|Drug|heparin-saline placebo|heparin-saline placebo catheter lock therapy
16189848|NCT01472939|Drug|SSP-002358 (0.1 mg) + PPI|0.1 mg tablet three times daily (t.i.d.) taken in addition to a PPI
16189849|NCT01472939|Drug|SSP-002358 (0.5 mg) + PPI|0.5 mg tablet t.i.d. taken in addition to a PPI
16189850|NCT01472939|Drug|SSP-002358 (2.0 mg) + PPI|2.0 mg tablet t.i.d. taken in addition to a PPI
16189851|NCT01472939|Drug|Placebo + PPI|Placebo t.i.d. taken in addition to a PPI
16189852|NCT01472926|Drug|Tenecteplase|Intravenous (IV) tenecteplase 0.25 mg/kg (single bolus; maximum dose 25 mg)
16189853|NCT01472926|Drug|alteplase|Intravenous alteplase 0.9mg/kg to maximum of 90mg, given as 10% bolus and 90% of dose over 1 hour infusion
16189854|NCT01472913|Drug|Fibrin sealant|Fibrin sealant is applied on the surfaces of bone and soft tissue of surgery after placement of the prothesis due to the randomised knee.
16189855|NCT01472913|Drug|Saline water|Same procedure to the opposite knee (the same patient) performed with sprayed saline water (placebo).
16189856|NCT01472900|Device|2940 nm Er:YAG laser (DualisXS M002-2A, Fotona®, Fotona d.d, Ljubljana, Slovenia)|2 passes of 2940nm Er:YAG laser
16189857|NCT01472900|Drug|Benzoyl Peroxide gel|2.5% benzoyl peroxide gel apply twice daily on inflammatory acne on the control side of face
16189858|NCT01472887|Drug|SAR3419|"Pharmaceutical form:concentrate for solution for infusion
~Route of administration: intravenous"
16189859|NCT01472874|Drug|Once a day Trientine|Trientine at a dosage of ~15 mg/kg rounded upwards to the nearest 250 or 300 mg in a single daily dosage. The entire daily dosage will be taken at once in the AM an hour before any meal. Duration of the study is 1 year.
16189860|NCT01472861|Procedure|AECC (Autologous endometrial coculture)|endometrial biopsy with autologous endometrial coculture
16189861|NCT01472861|Other|no endometrial biopsy or Autologous endometrial coculture (AECC) performed|routine procedures with out biopsy
16189862|NCT01472848|Drug|PF 05212389 or placebo|QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses ranging from low to high dose.
16189863|NCT01472848|Drug|PF 05212389 or placebo|QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses ranging from low to high dose.
16189864|NCT01472848|Drug|PF 05212389 or placebo|QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses to be determined from the results of previous cohorts
16189865|NCT01472848|Drug|PF 05212389 or placebo|QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses to be determined from the results of previous cohorts
16189866|NCT01472848|Drug|PF 05212389 or placebo|QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses to be determined from the results of previous cohorts
16189867|NCT01472848|Drug|PF 05212389 or placebo|QD SC administration of PF 05212389 (12 subjects) or matching placebo (3 subjects); doses to be determined from the results of previous cohorts
16189872|NCT01472809|Drug|ZYGK1|"ZYGK1 Tablets: 0.125, 0.25, 0.5, 1, 2, .... mg.
~Dose escalation will continue till single AE occurs in any block of 3 volunteers on ZYGK1 or pharmacokinetic (dose linearity) saturation is reached or desired PK/PD effect is achieved"
16189873|NCT01472809|Drug|Placebo|Placebo Tablets: 0.125, 0.25, 0.5, 1, 2, ... mg
16189874|NCT01472796|Dietary Supplement|Vitamin D (cholecalciferol)|Tekturna (Aliskirin) 300 mg per day supplemented with 50,000 IU Vitamin D every other week x 8 weeks
16189875|NCT01472796|Drug|Tekturna(Aliskiren) plus placebo|Aliskiren 300 mg per day supplemented with placebo
16189876|NCT01472783|Drug|Veliparib|Veliparib (tablet) 300 mg twice daily on days 1-28 of 28 days cycles until progression, unacceptable toxicity or patient refusal.
16189877|NCT01472770|Drug|Gemcitabine + Capecitabine|Gemcitabine: 1000 mg/m2 intravenously over 30 min. on day 1 in 2-weeks cycles. Capecitabine: Peroral tablet 2000 mg/m2 daily on days 1-7 in 2-weeks cycles.
16189878|NCT01472757|Drug|VR506|VR506 inhalation powder delivered via a new dry powder inhaler
16189879|NCT01472757|Drug|Placebo|Placebo delivered via a new dry powder inhaler
16189880|NCT01472744|Behavioral|Dance Group|Participants will be instructed and learn various forms of dance (i.e. English country, folk, ballroom) and will be led by trained dance instructors and exercise specialists. Participants will for one-hour sessions and meet three times per week for six months.
16189881|NCT01472744|Behavioral|Strength, Stretching, Stability|Exercises focusing on strength, flexibility and balance will be performed at one-hour sessions held three times per week for six months. Classes are led by trained exercise specialists.
16189882|NCT01472744|Behavioral|Walking|Participants in this moderate aerobic conditioning exercise program will be instructed in a walking program that focuses on having them walk within their target heart rate. They will be provided with heart rate monitors and pedometers for accurate record keeping. They will meet three times per week for one hour for six months. Warm up and cool down stretches will be a part of each walking session and sessions will be monitored and led by trained exercise specialists.
16189883|NCT01472744|Behavioral|Walking + Nutrition|Participants in this moderate aerobic conditioning exercise program will be instructed in a walking program that focuses on having them walk within their target heart rate. They will be provided with heart rate monitors and pedometers for accurate record keeping. They will meet three times per week for one hour for six months. Warm up and cool down stretches will be a part of each walking session and sessions will be monitored and led by trained exercise specialists. These participants will also be provided with a daily nutritionally balanced liquid, milk-based supplement formula.
16189884|NCT01472731|Other|89Zr-GC1008|radioactive labeled GC1008, intravenous use, 37 MBq total
16189885|NCT01472731|Drug|GC1008|5 mg/kg intravenous use
16189886|NCT01472718|Device|coronary thrombectomy|coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration)
16189887|NCT01472718|Device|standard primary PCI (with stenting, as required)|standard primary PCI (usually with stenting) for STEMI, without use of thrombectomy or distal protection devices
16189888|NCT01472692|Drug|Febuxostat|80mg PO daily for 8 weeks
16189889|NCT01472666|Dietary Supplement|High content of MC-SFA|12 weeks dietary intervention
16189890|NCT01472666|Dietary Supplement|Whey|12 weeks dietary intervention
16189891|NCT01472666|Dietary Supplement|Low content of MC-SFA|12 weeks dietary intervention
16189892|NCT01472666|Dietary Supplement|Casein|12 weeks dietary intervention
16189893|NCT01472653|Drug|cisplatin|cisplatin 30 mg/m2/week I.V. during radiotherapy
16189894|NCT01472653|Radiation|radiotherapy|3-dimensional conformal radiotherapy planning and delivery, 35x2 Gy/day over 7 weeks
16189895|NCT01472653|Drug|cetuximab|cetuximab 400 mg/m2 I.V. 1 week before the start of radiotherapy, cetuximab 250 mg2/week I.V. during radiotherapy
16189896|NCT01472640|Drug|liraglutide|1.8 mg sc QOD
16189897|NCT01472640|Drug|placebo|1 U sc QOD
16189898|NCT01472627|Procedure|Blood draws|Blood draws
16189899|NCT01472614|Drug|DLBS3233|Study treatment will be DLBS3233 at a dose of 100 mg once daily (for 12 weeks) in addition to current anti-diabetic treatment used by respective study subjects and treatment intensification (lifestyle modification)
16189900|NCT01472588|Behavioral|DPP lifestyle intervention-Community Health Coach (CHWs)|Lifestyle counseling. During a 16 month period, the behavioral weight loss program (n=24 sessions of the DPP lifestyle intervention) is delivered by CHWs in group format in community settings.
16189901|NCT01472588|Behavioral|DPP Lifestyle intervention--health professionals/(PHCs)|Lifestyle counseling. During a 16 month period, the behavioral weight loss program (n=24 sessions of the DPP lifestyle intervention) is delivered by PHCs in group format in community settings.
16189902|NCT01472588|Other|Self Help|Public education/information booklet on weight management.
16189903|NCT01472562|Drug|lenalidomide|"Induction phase: 20 mg/day for days 1-21 of a 28-day cycle for 12 cycles. If no excess toxicity is observed the dose will be increased to 25 mg/day.
~Maintenance phase: Lenalidomide will be given at 15 mg/day for days 1-21 of a 28-day cycle."
16189904|NCT01472562|Biological|rituximab|"Induction phase: Rituximab will be administered at 375 mg/m2 per dose for a total of 9 doses. The first 4 doses will be administered weekly starting on day 1 of lenalidomide (e.g. days 1, 8, 15 and 22). Subsequent rituximab doses will be administered for one dose each at weeks 12, 20, 28, 36 and 44.
~Maintenance phase: Rituximab at 375 mg/m2 per dose will be administered for one dose every 8 weeks, starting at week 52."
16189905|NCT01472549|Drug|Iodine-alcohol|Skin preparation with 8.3% povidone-iodine with 72.5% alcohol (Prevail-FX, Cardinal Health) preoperative skin preparation.
16189906|NCT01472549|Drug|Chlorhexidine-alcohol|Skin preparation with 2% chlorhexidine gluconate with 70% alcohol (ChloraPrep, Cardinal Health) preoperative skin preparation
16189907|NCT01472536|Behavioral|Sequestration|Students will be sequestered within their residence hall room for 3 days following influenza like illness symptoms.
16189908|NCT01472510|Drug|Ranibizumab|A 0.5mg intravitreal injection of Ranibizumab will be administered to subjects. Subjects will receive 6 monthly consecutive ranibizumab injections. Study visits will be scheduled to occur every 28 days relative to the date of the first injection
16189909|NCT01472510|Drug|Ranibizumab|A 0.5mg intravitreal injection of Ranibizumab will be administered to subjects. Subjects will receive 12 monthly consecutive ranibizumab injections. Study visits will be scheduled to occur every 28 days relative to the date of the first injection
16189910|NCT01472497|Drug|Pioglitazone|pioglitazone (15mg) once a day for 24 weeks
16189911|NCT01472484|Other|586/8x87 white|2 x 50 g
16189912|NCT01472484|Other|586/8x87 brown|2 x 50 g
16189913|NCT01472484|Other|BAT 881|2 x 50 g
16189914|NCT01472484|Other|586/8|2 x 50 g
16189915|NCT01472458|Behavioral|Quality improvement|The primary intervention in this project will be a multi-faceted quality improvement plan targeting improved predictions of neurological outcome and survival after cardiac arrest.
16189916|NCT01472445|Drug|Vitamin D|
16189917|NCT01472432|Drug|Placebo|Placebo is added to the standard good medical practice. Plus Metformin and/or Sulfonylurea
16189918|NCT01472432|Drug|vildagliptin|50 mg per os b.i.d. for 4 months of treatment, added to the standard good medical practice.Plus Metformin and/or Sulfonylurea
16189919|NCT01472406|Device|Sansum Closed-Loop Artificial Pancreas|The Sansum Closed-loop Artificial Pancreas Device is the infrastructure that allows communication between the insulin pump, the CGM, the zone-MPC, and the HMS.
16189920|NCT01472406|Device|Insulin infusion pump|The insulin pump, which has received 510k clearance (K080639), delivers insulin subcutaneously through an infusion set.
16189921|NCT01472406|Device|Continuous Glucose Monitor|The CGM, which is an approved device (P050012), measures interstitial glucose.
16189922|NCT01472406|Device|zone-Model Predictive Control algorithm|The zone-MPC predicts future glucose values, based on CGM data, to regulate blood glucose level by increasing, decreasing, or stopping insulin infusion via an insulin infusion pump.
16189923|NCT01472406|Device|Safety Health Monitoring System|The HMS predicts future glucose values, based on CGM data, to warn the Sansum Closed-loop Artificial Pancreas Device of values below 70 mg/dL.
16189924|NCT01472393|Dietary Supplement|Creatine supplementation|The CR group will receive either 1g or 3g of Cr monohydrate (Creapure®) per day throughout the trial. The dose of creatine will be formulated in a tablet.
16189925|NCT01472393|Dietary Supplement|dextrose (placebo)|The placebo group will be given the same dose of dextrose formulated in a tablet to be consumed under the same conditions. The two types of tablets will not be distinguishable from each other having the same appearance, taste and smell.
16189926|NCT01472380|Drug|efavirenz|600 mg
16189927|NCT01472380|Drug|fenofibric acid 105 mg|fenofibric acid 105 mg
16189928|NCT01472354|Behavioral|Leap-c group intervention|4-week group intervention to help HIV/HCV co-infected patients reframe negative appraisals associated with hCV treatment, increase HCV knowledge, increase skills related to working with health care providers
16189929|NCT01472328|Procedure|HBO therapy|Effect of 2 hrs HBO therapy on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus
16189930|NCT01472328|Procedure|Hyperbaric room air|Effect of 2 hrs hyperbaric room air on muscular insulin sensitivity and resistance in obesity and type 2 diabetes mellitus
16189931|NCT01472315|Drug|medroxyprogesterone acetate|MPA hormone therapy 30mg two hours before bedtime and 30mg right before going to bed every night for two weeks period
16189932|NCT01472315|Drug|Placebo|Placebo pills were taken in same way as active comparator
16189933|NCT01472302|Device|Adaptive Support Ventilation|Ventilation protocol according to the patients ideal body weight
16189934|NCT01472302|Device|Pressure Controlled Ventilation|Ventilation protocol (6-8 ml/kg tidal volume) according to our ICU
16189935|NCT01472289|Other|Autologous Bone Marrow Mononuclear cells (BMMNCs)|Multiple intramuscular injections of concentrated bone marrow derived mononuclear cells (0.5 cc/injection) into the ischemic muscle of the affected limb.
16189936|NCT01472276|Behavioral|Web-based program|Provided with the web-based program
16189937|NCT01472263|Drug|Pentoxifylline|Pentoxifylline 400mg 3 times a day on a total dose o 1200mg, oral capsules
16189938|NCT01472263|Drug|Placebo|Placebo capsules 3 times a day. The capsules have the same shape, color and form as the treatment group, and are identified by envelope numbers.
16189939|NCT01472250|Drug|Clinical chemo-drugs|"Clinical drugs will be selected by the investigator according to recommendations in Chinese and foreign guidelines and depending on clinical experience and the patient's individual conditions, including but not limited to the drugs listed below:
~Platinum products: oxaliplatin, cisplatin Fluorouracil products: 5-fluorouracil, capecitabine, TS-1 Taxanes: paclitaxel, docetaxel"
16189940|NCT01472237|Other|Nutritional intervention|Modification of diet
16189941|NCT01472211|Device|zinc enriching filter (LifeStrawFamily)|filter purifies water and enriches it with zinc at 1-4 mg/l.
16189942|NCT01472211|Device|placebo filter|filter purifies water
16189943|NCT01472211|Other|disinfection tablets|government promoted tablets disinfect water
16189944|NCT01472198|Drug|Simtuzumab|Simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15)
16189945|NCT01472198|Drug|Gemcitabine|Gemcitabine 1000 mg/m^2 administered intravenously on Days 1, 8, and 15 of each 28-day cycle
16189946|NCT01472198|Drug|Placebo to match simtuzumab|Placebo to match simtuzumab administered intravenously every 2 weeks for a total of 2 infusions (Days 1 and 15)
16189947|NCT01472185|Drug|Ranolazine|Ranolazine tablets administered orally twice daily.
16189948|NCT01472185|Drug|Placebo|Placebo to match ranolazine administered orally twice daily.
16189949|NCT01472185|Behavioral|Diet|Participants are instructed to continue the diet regimen prescribed by their physician.
16189950|NCT01472185|Behavioral|Exercise|Participants are instructed to continue the exercise regimen prescribed by their physician.
16189951|NCT01472172|Device|Cryobiopsy (Autoclavable cryoprobe 20416-032)|The tip of the cryoprobe will be attached to suspicious part of parietal pleura and activated by footswitch for 3 seconds. The frozen tissue is going to be extracted by gently pulling of the probe. The probe with the attached biopsy sample is going to be removed together with the thoracoscope through trocar. The biopsy sample will be released from the probe by thawing in the saline.
16189952|NCT01472159|Behavioral|CGM Family Teamwork Intervention|The family-focused behavioral intervention targets barriers associated with sustained CGM use in youth with type 1 diabetes. During months 1-18, families in the intervention group will participate in the intervention at each study visit for about an additional 30 minutes.
16190062|NCT01471496|Procedure|prophylactic injection therapy|Standard application of endoscopic injection therapy as it is used for actively bleeding ulcers, 10 ml of serum saline with 1/10000 epinephrine is submucosally injected to the four quadrants of the ulcer margins.
16189953|NCT01472146|Drug|Zo-Nantax|"Experimental:
~AC,Docetaxel,Trastuzumab,Zolendronate
~Drug: AC Adriamycin 60mg/m2 IV plus cyclophosphamide 600mg/m2 every 21 days for 4 cycles
~Drug: Docetaxel
~Docetaxel 100 mg/m2 every 21 days for 4 cycles.
~Drug: Trastuzumab
~Trastuzumab 8mg/kg [loading dose] once then 6mg/kg IV every 21 days for 3 cycles plus docetaxel.
~Drug: zolendronic acid
~Zolendronic acid 4mg IV every 21 days for 8 cycles combine with chemotherapy"
16189954|NCT01472133|Other|Recording of 12 lead ECG|Recording of 12 lead ECG
16189955|NCT01472133|Other|Recording of lying and standing blood pressure|Recording of lying and standing blood pressure
16189956|NCT01472133|Other|Recording of chest wall movement|Recording of chest wall movement
16189957|NCT01472133|Other|Recording of heart rate variability|Done during deep breathing and a valsalva manoeuvre
16189958|NCT01472133|Other|Recording of ECG and Pulse oximeter waveform at rest|For 10 mins
16189959|NCT01472133|Other|Recording of ECG and Pulse oximeter waveform during exercise|Recording of ECG and Pulse oximeter waveform during exercise
16189960|NCT01472081|Biological|Nivolumab|
16189961|NCT01472081|Biological|Pazopanib|
16189962|NCT01472081|Drug|Sunitinib|
16189963|NCT01472081|Biological|Ipilimumab|
16189964|NCT01472068|Device|Inko RS Device|30 minute pre-programmed treatment for 5 days out of 7. Treatment to be carried out while standing.
16189965|NCT01472055|Drug|Fludarabine|"Fludarabine 40 mg/m^2 once a day intravenous administration over 30 min
~Development of sampling-minimized analysis method through individualized pharmacokinetics Sampling time: 0hr (pre-dose), 30 min (post-dose), 1hr, 3hr, 5hr, 8hr, 24hr
~Population pharmacokinetics analysis
~Comparative analysis of population pharmacokinetics in pediatric and adult patients
~Analysis of population pharmacokinetics, toxicity, engraftment rate, survival rate"
16189966|NCT01472042|Other|Banyan Biomarkers|Biomarkers to detect specific proteins.
16189967|NCT01472029|Drug|5-FU, leucovorin, docetaxel, oxaliplatin (FLOT), trastuzumab|"Pre-operative treatment 4 cycles and post-operative treatment 4 cycles:
~Trastuzumab 4 mg/kg BW (6 mg loading dose at 1st administration), iv over 1 h on day 1 of each 14 day cycle
~Docetaxel 50 mg/m², iv over 2 h on day 1 of each 14 day cycle
~Oxaliplatin 85 mg/m² in 500 ml G5%, iv over 2h on day 1 of each 14 day cycle
~Leucovorin 200 mg/m² in 250 ml NaCl 0,9%, iv over 1 h on day 1 of each cycle
~5-FU 2600 mg/m², iv over 24 h on day 1 of each 14 day cycle"
16189968|NCT01472029|Drug|Post-operative treatment trastuzumab mono therapy|"Trastuzumab mono therapy for 9 cycles:
~Trastuzumab 6 mg/kg BW, iv over 1 h on day 1 of each 21 day cycle"
16189969|NCT01472016|Drug|ABT-700|ABT-700 will be administered by intravenous infusion at escalating dose levels on day 1 in 21-day dosing cycles. Additional subjects will be enrolled in an dose expansion cohort that will further evaluate ABT-700.
16189970|NCT01472016|Drug|docetaxel|Docetaxel will be administered by intravenous infusion on Day 1 in 21-day dosing cycles.
16189971|NCT01472016|Drug|FOLFIRI|5-fluorouracil, Folinic acid and Irinotecan will be administered by intravenous infusion on Day 1 and 15 in 28-day dosing cycles.
16189972|NCT01472016|Drug|cetuximab|Cetuximab will be administered by intravenous infusion weekly.
16189973|NCT01472016|Drug|erlotinib|Erlotinib will be taken orally daily.
16189974|NCT01472016|Drug|ABT-700|ABT-700 will be administered by intravenous infusion on Day 1 and Day 15 in 28-day dosing cycles.
16189975|NCT01472003|Drug|ABT-806|ABT-806 will be administered by intravenous infusion.
16189976|NCT01472003|Drug|ABT-806i|ABT-806i will be administered by intravenous infusion.
16189977|NCT01471990|Drug|Pituitary Adenylate Cyclase-Activating Polypeptide-38|10 pmol/kg/min over 20 mins
16189978|NCT01471990|Drug|Vasoactive Intestinal Peptide|8 pmol/kg/min over 20 mins
16189979|NCT01471977|Other|education,counseling, default tracers,quality of care|these interventions were administered along with standard treatment i.e. DOTS at the time of standard follow up of patients at clinic
16189980|NCT01471964|Drug|MLN8237 and Erlotinib|Erlotinib pills once every day and MLN8237 pills twice every day, day 1-7 of every 21 days
16189981|NCT01471951|Other|Single embryo transfer in women at risk of multiple pregnancies|Prospective study of single embryo transfers in selected women with good reproductive prognosis and high risk of multiple pregnancies in an IVF-ICSI program.. The day of the embryo transfer, the patients will be randomized by a computer application for morphological and morphometric embryo selection.
16189982|NCT01471925|Drug|Nexium®|
16189983|NCT01471925|Drug|Esomeprazol (40mg) + Sdium Bicarbonate (721mg)|
16189984|NCT01471912|Procedure|pars plana vitrectomy and fluid gas exchange|A three-port standard pars plana vitrectomy was performed by a single surgeon using a 23-gauge vitrectomy system, either Associate®(Dutch Ophthalmic Research Center. Inc., Zuidland, The Netherlands) or Accurus®(Alcon Laboratories Inc., Fort Worth, USA), with one step scleral tunnel incision. In all cases, the peeling of the internal limiting membrane, approximately 1 disc diameter area from center of MH was conducted without assistance of dyes followed by complete fluid-gas exchange using 25% sulfur hexafluoride gas. Combined cataract surgery was performed in patients with visually significant cataracts or with incipient cataract in the subjects older than 60 years. All patients were instructed to maintain a face-down position for at least 7 days postoperatively.
16189985|NCT01471899|Drug|Ketorolac Tromethamine|10 drops each 8 hours for 4 days.
16189986|NCT01471899|Drug|Naproxen|2 tablets every 8 hours for 4 days
16189987|NCT01471886|Drug|Ketorolac Tromethamine|Every 8 hours for 4 days.
16189988|NCT01471886|Drug|Naproxen|Every 8 hours for 4 days.
16189989|NCT01471873|Procedure|Corneal Collagen Cross-linking (CXL)|"The same surgical procedure was applied to all CXLG patients that included:
~Instillation of proparacaine hydrochloride 0.5% drops for topical anaesthesia, application of a sponge saturated with 10% alcohol to the central cornea for 20-30 seconds and subsequent de-epithelialization by means of a hockey knife. Following de-epithelialization, a mixture of 0.1% riboflavin in 20% Dextran solution was instilled to the cornea for 30 minutes (2 drops every 2 minutes) prior to the irradiation. In details, an 8.0mm diameter of central cornea was irradiated for 30 minutes by UVA light with a wavelength of 370nm and an irradiance of 3mW/cm2.The UVA radiation source that was used is the UV-XTM (IROC AG, Zurich, Switzerland). Instillation of riboflavin drops (1 drop every 2 minutes) was continued during irradiation, as well."
16189990|NCT01471860|Device|BAROSTIM NEO System|
16189991|NCT01471860|Drug|Medical Management|
16190311|NCT01469416|Drug|Clopidogrel|Clopidogrel 300 mg PO x 1 (30 minutes prior to rosuvastatin dose); Clopidogrel 75 mg PO x 1 (24 hours post-rosuvastatin dose)
16189992|NCT01471847|Drug|BEZ235 + Trastuzumab Phase l/Phase ll)|"Phase l: Patients will receive increasing doses of oral BEZ235 (BID) together with standard weekly trastuzumab at a fixed dose. BEZ235 doses will be escalated in cohorts of 3 to 6 patients guided by an adaptive Bayesian logistic regression model with overdose control until MTD/RP2D has been established.
~Phase ll: If randomized to the trastuzumab + BEZ235 arm, patients will receive standard weekly trastuzumab in combination with oral BEZ235 (BID) at the MTD or RP2D and will continue on study treatment until PD, unacceptable toxicity or until other pre-defined discontinuation criteria are met. They will have regular safety assessments and will be evaluated for response to treatment according to RECIST every 2 cycles for the first 36 weeks then every 12 weeks until disease progression (or start of new anti-neoplastic therapy)."
16189993|NCT01471847|Drug|Lapatinib + Capecitabine (Phase II)|"If randomized to the lapatinib + capecitabine treatment arm, patients will receive standard lapatinib plus capecitabine until PD, unacceptable toxicity or until other pre-defined discontinuation criteria are met.
~Patients will have regular safety assessments and will be evaluated for response to treatment according to RECIST every 2 cycles for the first 36 weeks then every 12 weeks until disease progression (or start of new anti-neoplastic therapy). After progression, survival f-up will continue.
~All patients participating in the Phase II part of the study will be required to have available archival or fresh tumor tissue for biomarker analysis prior to treatment start"
16189994|NCT01471834|Device|BAROSTIM NEO System|
16189995|NCT01471834|Drug|Medical Management|
16189996|NCT01471821|Drug|antiretroviral treatment|antiretroviral treatment
16189997|NCT01471808|Drug|CSII|continuous subcutaneous insulin infusion for 2~4 weeks
16189998|NCT01471808|Drug|CSII, Metformin, Pioglitazone|CSII for 2~4 weeks combined with metformin 1.5g/d and pioglitazone 30mg/d for 3 months.
16189999|NCT01471808|Drug|CSII, Sitagliptin|CSII for 2~4 weeks combined with sitagliptin 100mg/d for 3 months
16190000|NCT01471782|Biological|Blinatumomab|Administered by continuous intravenous infusion
16190001|NCT01471769|Behavioral|Pain management video|6-minute video
16190002|NCT01471769|Behavioral|Falls Prevention Video|6-minute video
16190003|NCT01471756|Procedure|Standard of Care Procedure as described in ARM|Standard of Care Procedure as described in ARM
16190004|NCT01471743|Dietary Supplement|Impact Advance Recovery (R)|
16190005|NCT01471743|Dietary Supplement|Ensure Plus (R)|
16190006|NCT01471730|Drug|Fibrinogen|All the patients randomized and not withdrawn will be tested 20 minutes before removal of aortic cross clamping with a Thromboelastometric fibrinogen test FIBTEM (Rotem) . They will all receive either human fibrinogen concentrate (according to the formula: (22 [mm] - MCF [mm]) * body weight [kg] / 140 [m] = whole g fibrinogen to be dosed as HFC) (treatment group) or placebo (control group). Study drug or placebo has to be administered after protamine.
16190007|NCT01471730|Drug|Saline solution|Normal saline will be administered to control patients.
16190008|NCT01471730|Drug|Prothrombin complex|After 15min from study drug administration and in presence of ongoing microvascular bleeding, we run a CT EXTEM. In case of prolonged CT time at EXTEM as long as 80 seconds [M1] , they will receive coagulation factors concentrates (Confidex) at a weight-based dose of 7 U/kg b.w. (treatment group) or placebo.
16190009|NCT01471717|Drug|INX-08189 50 mg QD X 5 days|Cohort 1: Subjects will begin administration of INX-08189 50 mg QD on Study Day 0. Dosing will occur each morning for 5 days after a fast of at least 8 hours prior to each dose on Study Days 0 through 4. INX-08189 will be administered with water, and subjects will remain fasting for 2 hours following each dose.
16190010|NCT01471717|Drug|INX-08189 / Victrelis 800 mg TID X three days|Cohort 1: INX-08189 50 mg QD will be administered concurrently with Victrelis 800 mg TID for 3 additional days (Study Days 5 through 7)
16190011|NCT01471717|Drug|Victrelis 800 mg TID x 3 days|In Cohort 2, subjects will begin administration of Victrelis 800 mg TID on the morning of Study Day 0. Victrelis will be administered with water and food with doses at least 7 hours apart. Victrelis 800 mg TID will be administered for a total of 3 days (Study Days 0 through 2).
16190012|NCT01471717|Drug|Victrelis 800 mg TID with INX-08189 50 mg QD|Victrelis 800 mg TID will be administered concurrently with INX-08189 50 mg QD for 5 additional days (Study Days 3 through 7).
16190013|NCT01471717|Drug|Placebo with Victrelis 800 mg|During combination dosing with INX-08189 and Victrelis, each morning dose will start with INX-08189 or placebo after at least an 8 hour fast, followed by a 2 hour fast with the first Victrelis dose of the day then administered with food.
16190014|NCT01471717|Drug|Cohort 2: Victrelis 800 mg with Placebo|During combination dosing with INX-08189 and Victrelis, each morning dose will start with INX-08189 or placebo after at least an 8 hour fast, followed by a 2 hour fast with the first Victrelis dose of the day then administered with food.
16190015|NCT01471704|Drug|INX-08189 50 mg|Study Day 0: Single 50 mg dose of INX-08189 in the morning
16190016|NCT01471704|Drug|240 mg verapamil HCL ER|Study Days 6 to 11: 240 mg verapamil HCL ER once daily (QD) in the morning
16190017|NCT01471704|Drug|50 mg dose of INX-08189 and 240 mg verapamil HCL ER|Study Day 12: Co-administration of single 50 mg dose of INX-08189 and 240 mg verapamil HCL ER in the morning
16190018|NCT01471691|Drug|ranibizumab 0.5mg|Standard dose
16190019|NCT01471691|Drug|ranibizumab 1.0mg|High dose
16190020|NCT01471678|Drug|Dutasteride (0.5mg)|This study is an open-label, randomized, single dose, four-period cross-over study.
16190021|NCT01471678|Drug|FDC product of dutasteride (0.5mg) and tamsulosin HCl (0.2mg)|FDC (with 10% enteric coated tamsulosin pellets); (2): FDC (with 15% enteric coated tamsulosin pellets);
16190022|NCT01471678|Drug|Harnal D Tablets and Harnal Capsules (both comprising 0.2 mg tamsulosin HCl)|a commercial formulation of dutasteride plus tamsulosin HCl (Harnal-D Tablet); (4): a commercial formulation of dutasteride plus tamsulosin HCl(Harnal Capsule). Each dosing session will be separated by a wash-out period of 5 to 10 days
16190023|NCT01471665|Drug|GSK2190915 100mg|GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor. Dosing will occur once daily for up to 16 days.
16190024|NCT01471665|Drug|Placebo|Placebo will be administered once daily for up to 16 days.
16190025|NCT01471548|Drug|TKI258|
16190098|NCT01471119|Biological|Dermatophagoides Farinae Drops Group 1|Dermatophagoides Farinae Drops Group 1 is the group with maintenance dose of 2 drops of grade 5 Dermatophagoides Farinae and 1 drop of placebo.
16190358|NCT01469052|Drug|AG-013736|Axitinib continuous oral dosing (15 mg once a day) in the fed state
16190026|NCT01471431|Other|spontaneous breathing trial|"The SBT is performed daily on rounds if an infant is on conventional ventilation and meets all predetermined ventilator criteria (set ventilator rate ≤30, peak inspiratory pressure (PIP) delivered on mandatory breaths ≤20 cm H2O, pressure support (PS) ≤8 cm H2O, positive end-expiratory pressure (PEEP) ≤6 cm H2O, inspired fractional oxygen (FiO2) ≤0.40).
~During the SBT, the ventilator rate and pressure support are set to zero, and the infant is maintained on continuous positive airway pressure (CPAP) alone via the endotracheal tube. The trial duration is 3 minutes, unless an infant fails before the trial is complete. Failure is defined as bradycardia <100 for >15 seconds or oxygen saturation by pulse oximetry <85% despite a 15% increase in FiO2. If an infant passes the SBT, they are extubated within 3 hours. If an infant fails the SBT, they remain intubated and the daily application of the SBT continues as long as the minimum ventilator criteria are met."
16190027|NCT01471418|Drug|PET/CT with 18-FDG|FDG uptake
16190028|NCT01471379|Drug|Milnacipran|50mg Milnacipran PO, BID, for 6 weeks.
16190029|NCT01471379|Drug|Milnacipran|Milnacipran, 100mg PO, BID, for six weeks
16190030|NCT01471379|Drug|Milnacipran|Milnacipran, 50mg PO BID for 12 weeks
16190031|NCT01471379|Drug|Placebo|Inactive pill, identical in shape, size, and appearance to active drug, PO, BID.
16190032|NCT01471366|Dietary Supplement|Frozen capsule|Two frozen fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of water without food or dairy products.
16190033|NCT01471366|Dietary Supplement|Capsule with food|Two room temperature fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of water with food but no dairy products
16190034|NCT01471366|Dietary Supplement|Capsule without food|Two room temperature fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of water with no food or dairy products
16190035|NCT01471366|Dietary Supplement|Capsule with milk|Two room temperature fish oil capsules (300 mg EPA/DHA per capsule) by mouth three times daily with 8 ounces of milk with no food or additional dairy products
16190036|NCT01471353|Drug|Sorafenib Plus Capecitabine (SorCape)|Sorafenib 200-400 mg PO twice daily on days 1-21 (dose escalation schema) plus Capecitabine 1000 mg/m2 PO twice daily on days 1-14 repeated every 21 days
16190037|NCT01471340|Drug|Mometasone Furoate/Formoterol MDI 100/5 mcg|two inhalations BID
16190038|NCT01471340|Drug|Mometasone Furoate/Formoterol MDI 200/5 mcg|two inhalations BID
16190039|NCT01471340|Drug|Mometasone Furoate MDI 100 mcg|two inhalations BID
16190040|NCT01471340|Drug|Mometasone Furoate MDI 200 mcg|two inhalations BID
16190041|NCT01471340|Drug|Albuterol 90 mcg /salbutamol 100 mcg HFA MDI|use as needed for asthma symptoms
16190042|NCT01471340|Drug|Prednisone/prednisolone|Oral prednisone/prednisolone used only as an emergency rescue medication at the discretion of the investigator
16190043|NCT01471652|Drug|Nutraceutical supplements|"CoEnzyme Q10: oral gel capsule bid
~Acetyl L-carnitine: oral capsule bid
~Alpha Lipoic Acid: oral tablet qd
~Docosahexaenoic acid: oral gel capsule bid"
16190044|NCT01471652|Drug|Placebo|"Capsule form to imitate the following nutraceuticals:
~Placebo 1: oral gel capsule bid
~Placebo 2: oral capsule bid
~Placebo 3: oral tablet qd
~Placebo 4: oral gel capsule bid"
16190045|NCT01471639|Drug|intranasal ketorolac|15 mg
16190046|NCT01471626|Device|polysomnograph Dream and Sleep Box|Portable polysomnograph will be placed at home around 7:00PM. The Sleep Box (wireless monitoring device) will be left near the patient, to allow real-time GPRS transmission of recorded sleep parameters to the sleep lab.
16190047|NCT01471613|Procedure|Conventional Treatment|Conventional treatment includes surgeries such as laminectomy, spinal decompression etc. and the medicine generally adapted to treat spinal cord injury
16190048|NCT01471613|Drug|Lithium Carbonate Tablet|250mg/tablet, administrated orally for 6 weeks.
16190049|NCT01471613|Biological|Cord Blood Cell|Cord blood mononuclear cell, 6.4 million viable cells, are transplanted into spinal cord at upper and lower edges of the injured site
16190050|NCT01471613|Other|Placebo|Placebo tablet, orally administration of placebo for 6 weeks
16190051|NCT01471600|Procedure|group drink|group glucose drink : 200 ml of fruit juice without pulp, ± 200ml coffee or tea, 2 at 4 hours before induction of anaesthesia
16190052|NCT01471574|Drug|Daclatasvir|Tablets; oral; 30, 60, or 90 mg; once daily; up to 24 weeks
16190053|NCT01471574|Drug|Ribavirin|Tablets; oral; for patients weighing <75 kg, the total dose is 1000 mg per day (2 200-mg tablets in the morning and 3 200-mg tablets in the evening); for patients weighing >75 kg, the total dose is 1200 mg per day (3 200-mg tablets in morning and 3 200-mg tablets in evening); twice daily with food; 24 or 48 weeks depending on response
16190054|NCT01471574|Drug|PEG-Interferon alfa 2a|Syringe, subcutaneous injection, 180 μg, once weekly, 24 or 48 weeks depending on response
16190055|NCT01471535|Drug|Pegylated interferon alfa-2a|patients were given peginterferon alfa-2a (40KD) (Pegasys®; Roche, Basel, Switzerland)180 µg by subcutaneous injection once weekly for 120 weeks
16190056|NCT01471522|Procedure|cardiac catheterization|Narrowed blood vessels can be opened without surgery using stents or can be bypassed with surgery. To determine which is the best approach for you the doctor needs to look at your blood vessels to see where the narrowings are and how much narrowing there is. This is done by a procedure known as a cardiac catheterization.
16190057|NCT01471522|Procedure|coronary artery bypass graft surgery|"Artery narrowing is bypassed during surgery with a healthy artery or vein from another part of the body. This is known as coronary artery bypass grafting, or CABG (said, cabbage). The surgery creates new routes around narrowed and blocked heart arteries. This allows more blood flow to the heart."
16190058|NCT01471522|Procedure|percutaneous coronary intervention|Percutaneous coronary intervention may be done as part of the cardiac catheterization procedure. With this procedure a small, hollow, mesh tube (stent) is inserted into the narrowed part of the artery. The stent pushes the plaque against the artery wall, and opens the vessel to allow better blood flow.
16190059|NCT01471522|Behavioral|Lifestyle|diet, physical activity, smoking cessation
16190060|NCT01471522|Drug|Medication|antiplatelet, statin, other lipid lowering, antihypertensive, and anti-ischemic medical therapies
16190061|NCT01471509|Other|water, glucose with or without amino acid|240 ml water, 50 g glucose ± 1 mmol amino acid/kg lean body mass
16190099|NCT01471119|Biological|Dermatophagoides Farinae Drops Group 2|Dermatophagoides Farinae Drops Group 2 is the group with maintenance dose of one drop of grade 5 Dermatophagoides Farinae and 2 drop of placebo.
16190063|NCT01471483|Behavioral|geriatric assessment and telephone call from nurse|The geriatric assessment will be completed at four time points: 1) on the day the patient receives a new chemotherapy regimen or within 30 days prior, 2) within 30 days of completion of the chemotherapy regimen (or at 12 months from study entry +/-30 days if the chemotherapy regimen is still being continued), 3) within 30 days prior to surgical debulking, and 4) 30 days after surgical debulking. The patient will receive a phone call once a week by a nurse who is an expert in caring for older patients. He/she will be asking questions about symptoms, medications and support at home. Each call is designed to last less than 30 minutes.
16190064|NCT01471483|Other|geriatric assessment and no call from nurse|The geriatric assessment will be completed at four time points: 1) on the day the patient receives a new chemotherapy regimen or within 30 days prior, 2) within 30 days of completion of the chemotherapy regimen (or at 12 months from study entry +/-30 days if the chemotherapy regimen is still being continued), 3) within 30 days prior to surgical debulking, and 4) 30 days after surgical debulking. They will not receive the phone calls, questions and symptoms will be addressed directly by the doctors and nurses on the medical and surgical teams.
16190065|NCT01471470|Drug|Docetaxel, Capecitabine, Cisplatin, Bevacizumab|Bevacizumab 7.5mg/kg IV (D1) Docetaxel 60 mg/m2 IV (D1) Cisplatin 60 mg/m2 IV (D1) Xeloda 1,875 mg/m2/day/bid PO (D1-D14)
16190066|NCT01471457|Drug|Trimo-San gel|Pessary wearers are instructed to apply one fingertip (approx 1 tablespoon) of Trimo-San gel inside the vagina or to the pessary (for women removing and cleaning pessary before reinsertion after cleaning) once nightly
16190067|NCT01471444|Drug|Fludarabine|"Flu + Bu Group: 40 mg/m2 by vein on Days -6 through -3.
~Flu +Clo + Bu Group: 10 mg/m2 by vein on Days -6 through -3."
16190068|NCT01471444|Drug|Clofarabine|30 mg/m2 diluted in normal saline to produce a final concentration of 0.4 mg/mL, and infused on Days -6 through -3.
16190069|NCT01471444|Drug|Busulfan|Busulfan systemic exposure dose of 6000 µMol-min in normal saline over three (3) hours by vein every twenty-four (24) hours for four (4) consecutive days (days -6 to -3), starting immediately after the completion of Clofarabine. The dose on day -6 to -3 based on pharmacokinetic analysis of target AUC of 4,000 µMol-min ± 5% for 61-70 years of age (without Pharmacokinetics alternate dose 130 mg/m2).
16190070|NCT01471444|Drug|Thymoglobulin|"Both groups who receive a graft from an unrelated donor:
~0.5 mg/kg on day -3, 1.5 mg/kg on day -2 and 2.0 mg/kg on day -1. On day -3, administered after the chemotherapy is complete."
16190071|NCT01471444|Procedure|Stem Cell Infusion|Cryopreserved bone marrow or peripheral blood progenitor cells infused on day 0.
16190072|NCT01471444|Drug|Tacrolimus|Starting dose: 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml. Changed to oral dosing when tolerated and can be tapered off after day +90 if no graft versus host disease (GVHD) present.
16190073|NCT01471444|Drug|Methotrexate|5 mg/m2 by vein on Days 1, 3, 6 and 11 post transplant.
16190074|NCT01471392|Device|STD Diagnostic Kit (Identigene)|The Identigene STD Test Collection Kit is an at-home kit that allows individuals to utilize the Gen-Probe technology to test for CT and NG in privacy and in a more convenient manner. The primary technology is the approved Gen-Probe APTIMA Combo 2 assay, which is repackaged into the Identigene kit for use by consumers. As such, the laboratory technology and testing method is identical to that of the Gen-Probe APTIMA Combo 2 assay, which has been cleared for in vitro diagnostic use.
16190075|NCT01471327|Biological|SB-240563|10mg, 75mg, 250mg and 750mg IV, single dose on Day 1
16190076|NCT01471327|Other|Placebo|Saline IV, single dose at Day 1
16190077|NCT01471314|Behavioral|Headache day versus non-headache day|
16190078|NCT01471288|Drug|Carum Cravi|40mg/kg of body weight
16190079|NCT01471288|Drug|Placebo|Placebo
16190080|NCT01471275|Drug|Metformin|250 mg or 500mg three times a day
16190081|NCT01471275|Drug|Jiangtangtiaozhi decoction|15 grams each time, twice a day, with boiled water
16190082|NCT01471262|Procedure|Right hepatectomy|Right liver resection
16190083|NCT01471262|Procedure|Extended right hepatectomy|Right hepatectomy involving 5 or more segments
16190084|NCT01471236|Device|Agili-C Bi-phasic Implant|"The implantation site should be created in perpendicular manner to the articular cartilage. The surrounding tissue will be cleaned and scraped to prepare a clean site. The implant will be placed in the correct orientation (drilled channels pointing towards the joint side and chamfer towards the bone).
~The implant will be inserted gently in a pressed fit manner."
16190085|NCT01471236|Procedure|mini-arthrotomy|"The procedure will be conducted according to hospital practice. The implants will be positioned via open incision, depending on lesion location, and Investigator's final decision. Related treatments during the procedure should be recorded.
~Device positioning details medications and adverse events during the procedure will be recorded. MOCART (off-site), X-ray evaluation (off-site), ICRS Cartilage injury mapping system, Articular cartilage injury Classification and the Osteochondritis Dissecans classification will be recorded."
16190086|NCT01471210|Drug|Urelumab (BMS-663513)|
16190087|NCT01471197|Biological|Ipilimumab|Intravenous (IV) solution, IV, 10mg/kg, Once every 3 weeks for 4 doses, then once every 12 weeks during Treatment Phase, 90 minute infusion
16190088|NCT01471197|Biological|Pemetrexed|IV solution, IV, 500 mg/m2, Once every 3 weeks during Treatment Phase, 10 minute infusion.
16190089|NCT01471184|Device|Ectoin® Allergy Nasal Spray and Ectoin® Allergy Eye Drops|
16190090|NCT01471184|Device|Placebo|Placebo Eye Drops/Nasal Spray
16190091|NCT01471171|Drug|Aclidinium Bromide|1 puff of 400 micro grams in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)
16190092|NCT01471171|Drug|Placebo|1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h)
16190093|NCT01471158|Drug|Brinzolamide/Timolol Maleate Fixed Combination (AZARGA)|Brinzolamide/timolol maleate fixed combination, one drop instilled in one eye at baseline, followed by one drop instilled in each eye once in either first intervention period or second intervention period.
16190094|NCT01471158|Drug|Dorzolamide/timolol Maleate Fixed Combination (COSOPT)|Dorzolamide/timolol maleate fixed combination, one drop instilled in one eye at baseline, followed by one drop instilled in each eye once in either first intervention period or second intervention period.
16190095|NCT01471145|Drug|Naltrexone|naltrexone for extended-release injectable suspension, 380 mg/vial, every 4 weeks or once a month
16190096|NCT01471132|Drug|Oxaliplatin|Oxaliplatin 345mg/m2,43℃，30mins
16190097|NCT01471132|Drug|Paclitaxel|Paclitaxel 260mg/m2,43℃，30mins
16190100|NCT01471119|Biological|Dermatophagoides Farinae Drops Group 3|Dermatophagoides Farinae Drops Group 3 is the group with maintenance dose of 3 drops of grade 4 Dermatophagoides Farinae.
16190101|NCT01471119|Biological|Placebo|Placebo Group is the group with maintenance dose of 3 drops of placebo.
16190103|NCT01471093|Drug|OPC-12759 Ophthalmic solution|2％ OPC-12759 Ophthalmic solution
16190104|NCT01471093|Drug|OPC-12759 Ophthalmic suspension|2％ OPC-12759 Ophthalmic suspension
16190105|NCT01471080|Procedure|RFA|using RFA to treat cavernous hemangiomas
16190106|NCT01471080|Procedure|hepatectomy|using hepatectomy to treat cavernous hemangiomas
16190107|NCT01471067|Drug|Melphalan|140 mg/m2 by vein on Day -2 only for Fludarabine + Melphalan group.
16190108|NCT01471067|Drug|Fludarabine|10 mg/m2 by vein on Days -7 to -4 for Melphalan + Thiotepa + Fludarabine group, or 40 mg on Days -5 to -2 for Fludarabine + Melphalan group.
16190109|NCT01471067|Drug|Mycophenolate mofetil|15 mg/kg (actual body weight with a maximum dose of 1 gram twice daily) by vein or by mouth twice a day from Days -3 to +100 in the absence of Graft vs Host Disease (GvHD).
16190110|NCT01471067|Drug|Tacrolimus|Starting dose 0.03 mg/kg or 0.015 mg/kg (ideal body weight) by vein starting on Day -2 and tapered around Day +180 if no Graft vs Host Disease (GvHD) is present.
16190111|NCT01471067|Procedure|Cord Blood Infusion|Cord blood infusion on Day 0. Each participant will receive cells from one unexpanded cord blood sample plus cells from a second cord blood sample that has undergone fucosylation.
16190112|NCT01471067|Drug|Rituximab|375 mg/m^2 by vein on Day -10 for B cell malignancy.
16190113|NCT01471067|Drug|ATG|"1.25 mg/Kg by vein on Day -4.
~1.75 mg/Kg by vein on Day -3."
16190114|NCT01471067|Drug|Busulfan|Busulfan per standard of care, test dose either as an outpatient prior to admission or as an inpatient on Day -9. Busulfan pharmacokinetics performed with test dose and the first dose on Day -7 per standard of care. Doses of Days -5 and -4 subsequently adjusted to target an AUC of 4,000 microMol.min-1.
16190115|NCT01471067|Drug|Clofarabine|30 mg/m^2 IV Day -7 to Day -4;
16190116|NCT01471067|Radiation|Total Body Irradiation (TBI)|2 Gy in AM of Day -3.
16190117|NCT01471054|Drug|Ozurdex|"Eyes in the Ozurdex group can have a maximum total of three Ozurdex insertions in the first 12 months after enrolling into the study. The criteria for retreatment with Ozurdex are:
~i.The study eye must have shown initial favorable response to prior Ozurdex implant (>10% decrease in central macular thickness with maintenance [change in BCVA of <=1 line] or improvement of visual acuity [increase of BCVA of >1 line]) ii. Interval since last Ozurdex implant should be > 4 and < 12 months. iii. The study eye must show definite evidence of recurrence of macular edema."
16190118|NCT01471054|Drug|Bevacizumab|Eyes in the Bevacizumab group can have a maximum total of twelve bevacizumab injections in the first year after enrolling into the study. All patients will receive 6 monthly injections after entering the study. After the sixth injection (at month 5) the interval between injections will be extended to 6 weeks if the study eye has shown initial favorable response to prior intravitreal bevacizumab.
16190119|NCT01471041|Device|Venous Window Needle Guide|Subcutaneous, extravascular needle guide made of medical-grade titanium
16190120|NCT01471028|Biological|ELAD treatment|ELAD treatment consists of treatment with an extracorporeal liver assist system.
16190121|NCT01471028|Other|Standard of care (Control)|Control receives standard medical treatment.
16190122|NCT01471015|Drug|Darbepoetin alfa|10 mcg/kg/dose x2, with the first dose given as IV within 12 hours of delivery and the second dose given as IV or SQ at 7 days old.
16190123|NCT01471015|Drug|Darbepoetin alfa|2 mcg/kg/dose x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old.
16190124|NCT01471015|Drug|Placebo|Placebo given x2, with the first dose given IV within 12 hours of delivery and the second dose given IV or SQ at 7 days old
16190125|NCT01471002|Device|Galil Medical patented 17G Cryoablation Needles|
16190126|NCT01470989|Drug|ACZ885|canakinumab 150 mg s.c., given on demand upon new flares
16190127|NCT01470989|Drug|Triamcinolone acetonide 40 mg|Participants received 40 mg intramuscular (IM)
16190128|NCT01470976|Other|Goal-directed Resuscitation Therapy (GDT)|"A target value of a cardiac index (CI) greater than 3.0 L/min/m2 will be sought.
~The first step will be fluid resuscitation with 250ml aliquots of Lactated Ringer's solution whenever the CI is lower than 3,0 L/min/m2 and systolic volume index (SVI) is lower than 35ml/m2. The fluid challenge will be stopped if the CVP rises by more than 4 mmHg during the infusion period.
~When the CI is lower than or equal to 3,0L/min/m2 and SVI higher than or equal to 35 ml/m2, dobutamine will be initiated with increasing doses up to 20mcg/kg/min.
~The final step will be red blood transfusion to reach a hematocrit higher than 28%."
16190129|NCT01470976|Other|Standard protocol|The control group will be managed by the anesthetic team in the operative room and by the surgical ICU staff in the postoperative period according to institutional protocol of hemodynamic monitoring.
16190130|NCT01470963|Other|Implementation of referral template|Implementation of referral template at the GP office
16190131|NCT01470950|Procedure|Motionmaker|3 times per week, FES Training on the Motionmaker device, for 6 months
16190132|NCT01470937|Drug|Acarbose|acarbose 100 mg PO once daily
16190133|NCT01470937|Drug|Placebo|acarbose placebo
16190134|NCT01470911|Drug|SB010|"Six ascending dose groups (DG) are planned, with a total of 48 subjects. DG 1 and 2 will consist of n=6 subjects (n=3 receiving SB010, n=3 placebo). The following DG will consist of n=9 subjects (n=6 receiving SB010, n=3 placebo). The number of subjects to be exposed to active compound will be limited on a particular study day. Subjects of a particular DG will be divided into subgroups and exposed to the drug on different days. In DG 1 and 2, the time interval between the two administrations of the first subgroup will be at least 2 hours. In DG 3-6, the time interval between two subsequent administrations will be at least 1 hour.
~Dose level (DL) 1: 0.4 mg hgd40/2 mL; DL 2: 2 mg hgd40/2 mL; DL 3: 5 mg hgd40/2 mL; DL 4: 10 mg hgd40/2 mL; DL 5: 20 mg hgd40/2 mL; DL 6: 40 mg hgd40/2 mL."
16190200|NCT01470365|Procedure|quality-of-life assessment|Ancillary studies
16190201|NCT01470365|Radiation|intensity-modulated radiation therapy|Undergo IMRT
16190202|NCT01470365|Radiation|3-dimensional conformal radiation therapy|Undergo 3-dimensional CRT
16190203|NCT01470352|Drug|Doluxetine|30 mg/d
16190204|NCT01470352|Drug|Placebo|suger pill 30mg/d
16190135|NCT01470911|Drug|Placebo|Six ascending dose groups (DG) are planned, with a total of 48 subjects. DG 1 and 2 will consist of n=6 subjects (n=3 receiving SB010, n=3 placebo). The following DG will consist of n=9 subjects (n=6 receiving SB010, n=3 placebo). The number of subjects to be exposed to active compound will be limited on a particular study day. Subjects of a particular DG will be divided into subgroups and exposed to the drug on different days. In DG 1 and 2, the time interval between the two administrations of the first subgroup will be at least 2 hours. In DG 3-6, the time interval between two subsequent administrations will be at least 1 hour.
16190136|NCT01470898|Device|bispectral index monitoring|A BIS sensor was applied to patient's forehead before induction of anesthesia and connected to A-2000 BIS monitor (Aspect Medical Systems, Newton, MA, USA). It records the electroencephalogram from 4 electrodes and after processing it with mathematic algorithms it generates a number from 0 to 100. When the BIS value is lower than 40, the patient is in deep anesthesia state, when the value is over 80, the patient is under light sedation.At the induction of anesthesia, and every 15 minutes during operation following parameters were recorded: heart rate (HR), systolic blood pressure (BP), end-tidal CO2 (etCO2) and BIS level. Also, operation time and extubation time were recorded. Finally, all patients were visited on the first postoperative day and interviewed about intraoperative recall.
16190137|NCT01470859|Drug|pramipexole|tablets, 0.375mg-4.5mg/day divided by 3 times according to the optimal improvement of motor dysfunction in PD patients. duration is 1 year.
16190138|NCT01470859|Drug|Sinemet CR|tablet of Sinemet CR, dosage of levodopa ranging from 200mg-600mg/day divided by 2 or 3 times, Duration is 1 year
16190139|NCT01470846|Procedure|epidural analgesia|thoracic position (T8-T9 or T11-T12) depending on the site of surgery
16190140|NCT01470846|Procedure|PCA|Morphine 2 mg / 10 min (no max dose) + droperidol 2.5 mg / 50 mL.
16190141|NCT01470833|Procedure|Early weight-bearing|"The group allowed early weight-bearing is instructed as follows:
~Week 1 to 2 Weight-bearing is allowed with in pain limit. Crutches are recommended.
~Week 3 to 4 Full weight-bearing is allowed. Week 5 to 8 Full weight-bearing is allowed. Crutches should be avoided.
~Dynamic rehabilitation From day 15 patients of both groups must do ankle exercises. Minimum 5 times a day the patient must take of the orthosis. Sitting at a table with the leg hanging freely over the edge a series of 25 active dorsal flexion and passive plantar flexion exercises must be made."
16190142|NCT01470820|Other|Phototherapy with blue light|The infants were placed in a bassinet with the phototherapy device placed above them. All infants were exposed naked (apart from eye pads and diaper) to continuously phototherapy for 24 hours, interrupted only for feeding and nursing for 30 minutes every three hours. TsB was determined before phototherapy and after 24 hours of treatment. The phototherapy apparatus used was neoBLUE LED phototherapy device (Natus Medical Inc., San Carlos, CA, USA) emitting blue light with an emission peak at 460 nm and a bandwidth of 450-470 nm. The irradiance was measured by use of the neoBLUE LED phototherapy radiometer (Natus Medical Inc.) every 8th hour at the infants head, trunk and knees and the average was calculated. The radiometer measures spectral irradiance in the range 420-500 nm with maximum sensitivity in the spectrum 440-480 nm.
16190143|NCT01470807|Device|portable artificial pancreas system with CTR algorithms|The investigators will test the new portable CTR system in CRC conditions for 10h followed by 18h of CTR in a hotel.
16190144|NCT01470794|Biological|Toca 511 vector|All patients will receive Toca 511, a retroviral replicating vector that expresses the cytosine deaminase (CD) gene. CD converts the antifungal 5-FC to the anti-cancer drug 5-FU in cells that have been infected by the Toca 511 vector. Beginning approximately 6 weeks after administration of Toca 511, patients will begin courses of oral Toca FC at pre-specified intervals, depending on cohort, during the approximately 30 week study.
16190145|NCT01470794|Drug|Toca FC|
16190146|NCT01470781|Behavioral|BrainWorks|"13 programs targeting cognition in 4 separate domains: Auditory processing, visual processing, social cognition, and executive functioning. Games are imbedded in a format that is engaging and interactive. Animated characters serve as directors for each program, explaining the tasks in both verbal and written formats and providing feedback on each trial and overall after each activity. Users move systematically through the programs and can track their progress as the go. Each session includes activities from several different games to maintain interest and train a variety of skills; however, games are presented in the order of domains listed above (i.e. auditory, then visual, then social, and finally executive) to avoid stimulus interference during the training."
16190147|NCT01470781|Behavioral|Computer Control|"Sessions will involve generic computer games administered via the game interface Sporcle. Sporcle is a game site that offers a collection of quiz-type activities available on line. The activities include typing, basic timed arithmetic (e.g. simple addition); picture identification (e.g. name the corporate logo; name the sitcom), and subject-based quizzes in areas like history (e.g. name the US presidents), geography (e.g. name the state capitals), and literature (e.g. book title fill-in-the-blank). An administrator can track the activity of subjects including when they logged in, which games they played and for how long, and what their accuracy was on each game. We will use a pre-developed game schedule that includes a mix of each type of game in each session, and ensures that subjects are playing the same games in the same order. This format was developed to mirror the treatment condition, as subjects are given a variety of specific games to play at each session."
16190148|NCT01470768|Other|Amino Acid-based Formula with high DHA and ARA|
16190149|NCT01470768|Other|Amino Acid-based Formula with lower DHA and ARA|
16190150|NCT01470755|Drug|salbutamol|Metered dose inhaler, 100µg+300µg per puff, administered one day
16190151|NCT01470755|Drug|Salbutamol - dose2|Metered dose inhaler, 100µg+500µg per puff, administered one day
16190152|NCT01470755|Drug|Salbutamol -dose3|Metered dose inhaler, 200µg+600µg per puff, administered one day
16190153|NCT01470755|Drug|salbutamol -dose4|Metered dose inhaler, 200µg+200µg per puff, administered one day
16190154|NCT01470742|Drug|XELOX|D1-14 Capecitabine 1000mg/m2 bid D1 Oxaliplatin 110mg/m2 + D5W 250ml over 2hr every 3weeks
16190155|NCT01470742|Drug|XELODA|Capecitabine 1000mg/m2 bid D1-14 every 3weeks
16190156|NCT01470729|Other|metabolic and imaging biomarkers in SCA1,2,3 and 7 patients|MRI, a bone mineral density and a resting metabolic rate assessments, as well as donating fasted blood samples
16190157|NCT01470716|Drug|Erlotinib|Neo-adjuvant Erlotinib treatment during maximum 8 weeks.
16190205|NCT01470339|Drug|duloxetine|duloxetine 60mg once a day for 5 weeks
16190206|NCT01470326|Drug|Bazedoxifene|For adults, take 1 tablet (20 mg of the active ingredient) at a time, once a day.
16190158|NCT01470703|Device|ECMO (Quadrox®, Jostra®, Maquet®)|ECMO will be initiated as rapidly as possible by venovenous access. The material to be used consists of pre-heparinized cannulae and tubing, a centrifuge pump (CardioHelp®) and a heparinized membrane oxygenator (Quadrox®, Jostra®, Maquet®). To minimize the trauma induced by mechanical ventilation, the following ventilator settings will be used: volume-assist control mode, FiO2 30-60%, PEEP ≥10 cm H2O, VT lowered to obtain a plateau pressure <25 cm H2O, respiration rate (RR) 10-30/minute or APRV mode with high pressure level <25 cm H2O and low pressure level ≥10 cm H2O
16190159|NCT01470703|Other|conventional care|Standard management of ARDS, according to the modalities applied by the 'maximal pulmonary recruitment' group in the EXPRESS trial (1): assist-controlled ventilatory mode, VT set at 6 ml/kg of ideal body weight and PEEP set so as not to exceed a plateau pressure of 28-30 cm H2O. In the case of refractory hypoxemia, the usual adjunctive therapeutics can be used: NO, prone position, HFO ventilation, almitrine infusion. A cross-over option to ECMO will be possible in the case of refractory hypoxemia defined as blood arterial saturation SaO2 <80% for >6 hours, despite mandatory use of recruitment maneuvers, and inhaled NO/prostacyclin and if technically possible a test of prone position, and only if the patient has no irreversible multiple organ failure and if the physician in charge of the patient believes that this could actually change the outcome
16190160|NCT01470690|Drug|boceprevir|Boceprevir 800 mg TID for 4 consecutive days + a single dose of 800 mg on Day 5
16190161|NCT01470690|Drug|Omeprazole|Omeprazole 40 mg QD for 5 consecutive days
16190162|NCT01470677|Drug|Tachosil fibrin patch|A Tachosil® patch of 4.8x4.8cm will be attached to the obturator fossa and a Tachosil® patch of 4.8x4.8cm will be attached to the femoral canal of each side of surgery in the intervention group. In the control group, no Tachosil® patch will be used. No specific drainage of the retroperitoneum will be performed.
16190163|NCT01470664|Drug|FST-100|0.1% dexamethasone and 0.6% polyvinylpyrrolidone iodine (PVP-Iodine)
16190164|NCT01470664|Drug|FST-100 (Component #1)|0.6% PVP-Iodine ophthalmic solution alone
16190165|NCT01470664|Drug|FST-100 Vehicle|FST-100 Vehicle
16190166|NCT01470651|Drug|Armodafinil|50mg - 250mg pills, taken each morning, for 14 weeks
16190167|NCT01470651|Drug|Sugar Pill|Inactive pill, matched to look like active medication
16190168|NCT01470625|Other|LCP Program|The LCP Program is continuous quality improvement program of end-of-life care implemented in hospice
16190169|NCT01470612|Drug|CP-690,550|5 mg tablets, BID, for at least 12 months
16190170|NCT01470612|Drug|CP-690,550|10 mg tablets, BID, for at least 12 months
16190171|NCT01470599|Drug|CP-690,550|ORAL TABLET, TWICE DAILY
16190172|NCT01470599|Drug|CP-690,550|ORAL TABLETS, TWICE DAILY
16190173|NCT01470586|Procedure|Surgery for colorectal cancer|Surgical resection of colorectal cancer
16190174|NCT01470573|Procedure|biological replacement corneal surface|the expanded tissue will be applied to patient to replace the damaged ocular surface
16190175|NCT01470560|Behavioral|Mindfulness-Based Stress Reduction (MBSR)|Mindfulness-Based Stress Reduction (MBSR) was developed by Jon Kabat-Zinn in 1979. MBSR is a group-based intervention, typically provided to up to 30 participants, in a class-based format of eight weekly two hour sessions.
16190176|NCT01470560|Behavioral|Sham Yoga Group|Emphasis will be placed on healthy alignment and ways to pace and adjust poses to make them safe and productive for the body.
16190177|NCT01470534|Dietary Supplement|carbohydrate drink|carbohydrate drink
16190178|NCT01470534|Procedure|Muscle biopsy|Open muscle biopsy
16190179|NCT01470534|Procedure|Blood sampling|Venopuncture
16190180|NCT01470534|Dietary Supplement|Placebo|
16190181|NCT01470521|Biological|Hookworm larvae|Hookworm larvae solution is pipetted onto a plaster dressing which is then placed on the upper forearm for 24 hours. This is administered only once.
16190182|NCT01470521|Biological|Placebo|Pharmacopoeial grade water is pipetted onto a plaster dressing which is then placed on the upper forearm for 24 hours. This is administered only once.
16190183|NCT01470508|Behavioral|Cognitive Behavioral Therapy|Individuals meet with a therapist once a week for 25 sessions, 50 minutes in length, for a period of 27 weeks for therapy. Cognitive Behavioral Therapy is manualized and is the standard form of care at the UNC Eating Disorders Program.
16190184|NCT01470508|Behavioral|Cognitive Behavioral Therapy with Family Enhancement|Individuals will meet with a therapist once a week for 25 sessions, 50 minutes in length, for a period of 27 weeks for therapy. Cognitive Behavioral Therapy with Family Enhancement is manualized and will involve the participation of family members during six (6) weeks of treatment.
16190185|NCT01470495|Other|RFA + Sorafenib|combined RFA and Sorafenib to treat recurrent HCC
16190186|NCT01470495|Other|RFA|treat Recurrent HCC with RFA
16190187|NCT01470482|Procedure|No use of tourniquet|Tourniquet is not applied i 25 pts
16190188|NCT01470482|Procedure|Tourniquet|Use of tourniquet
16190189|NCT01470469|Drug|SPD503 (extended-release Guanfacine hydrochloride)|Once-daily oral dosing of SPD503 in the evening ranging from 1-6 mg for 12 weeks (6 week dose optimization and 6 week dose maintenance).
16190190|NCT01470469|Drug|Placebo|Once-daily oral dosing in the evening for 12 weeks.
16190191|NCT01470456|Drug|SAR3419|Pharmaceutical form:solution for infusion Route of administration: Intravenous
16190192|NCT01470456|Drug|rituximab|Pharmaceutical form:solution for infusion Route of administration: intravenous
16190193|NCT01470443|Drug|Oxaliplatin|Oxaliplatin 130mg/㎡, day 1, every 3 weeks
16190194|NCT01470443|Drug|Oxaliplatin|Oxaliplatin 100 mg/㎡, day 1, every 3 weeks
16190195|NCT01470417|Drug|Chemotherapy|Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with low risk disease will have an additional two cycles of therapy (4 total cycles) prior to resection.
16190196|NCT01470417|Drug|Chemotherapy + ChemoRadiotherapy|Nab-paclitaxel 100 mg/m2 IV over 30 minutes on days 1, 8, and 15 along with gemcitabine 1000 mg/m2 IV over 30 minutes on days 1, 8, and 15 in an every 28 day cycle for two cycles. Subjects with high-risk or borderline resectable disease will receive additional chemotherapy with radiation therapy prior to resection.
16190197|NCT01470391|Procedure|Adductor-Canal-Blockade|US-guided Adductor-Canal-Blockade with Ropivacaine
16190198|NCT01470391|Procedure|Femoral Nerve Block|US-guided Femoral Nerve Block with Ropivacaine
16190199|NCT01470378|Procedure|Thigh Surgery|Circumferential thigh surgery post bariatric surgery
16190207|NCT01470313|Drug|PD-0360324|Subjects will receive PD-0360324 intravenously in 3 different cohorts. The cohorts will be evaluated in ascending fashion. The doses planned are 100 mg every other week for 3 months, 150 mg every other week for 3 months, and 200 mg every 4 weeks for 3 months.
16190208|NCT01470313|Drug|Placebo|Placebo is normal saline. The timing of placebo administration will depend of the dosing frequency of the cohort (either every other week for 3 months or every 4 weeks for 3 months).
16190209|NCT01470300|Other|Energy density feeding study|In a crossover design, adults are served breakfast, lunch, and dinner, 1 day a week for 4 weeks. Meal entrees will vary in energy density (100% and 80%) and the method used to reduce the energy density (added fruit & vegetables, decreased fat, added plain water).
16190210|NCT01470287|Biological|DTwP-HepB-Hib Vaccine|Open label, Single arm study to evaluate immunogenicity, safety and tolerability of a fully liquid pentavalent (DTwP-HepB-Hib) vaccine in infants of 6-8 weeks of age.
16190211|NCT01470248|Drug|Arsenic Trioxide|Drug will be given as a loading dose of 0.32mg/kg/day for 4 days in Week 1, followed by 0.25mg/kg/day twice per week for 5 weeks, followed by 2 weeks of rest, at which time response assessment will be performed. Patients will be restaged prior to the beginning of a new cycle, every 2 months on average. Maximum of 6 cycles of therapy will be administered in the absence of tumor progression or excessive side effects
16190212|NCT01470222|Other|Weight loss intervention|Menu-based recommendations to consume a high fiber, low glycemic load diet with education on nutrition and behavior change.
16190213|NCT01470209|Drug|BKM120|BKM120 (20mg to 100mg) will be self-administered (by the patients themselves). The investigator will instruct the patient to take the study drug exactly as specified in the protocol. BKM120 will be administered on a continuous once daily dosing schedule. Patients should be instructed to take the dose of BKM120 daily in the morning, one hour after a light breakfast (morning meal) at approximately the same time each day. BKM120 should be taken with a glass of water and consumed over as short a time as possible. Patients should swallow the capsules as a whole and not chew them. Patients should continue to fast for 2 hours after the administration of each BKM120 dose.
16190214|NCT01470209|Drug|Everolimus|RAD001 will be self-administered (by the patients themselves). The investigator will instruct the patient to take the study drug exactly as specified in the protocol. RAD001 will be administered orally as once daily dose of 5mg or 10 mg (based on the dose cohort) continuously from study day 1 until progression of disease or unacceptable toxicity. Patients will be instructed to take RAD001 in the morning, at the same time each day.
16190215|NCT01470196|Drug|Dexamethasone|20 mg IV on Days 1, 2, 8, 9, of 21 day cycle for cycles 1-6 20 mg IV on Days 1, 2 of 21 day cycles q 2 months for cycles 1-8
16190216|NCT01470196|Drug|Carfilzomib|20 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycle 1 36 mg/m2 IV on Days 1, 2, 8, 9 of 21 day cycles for Cycles 2-6 36 mg/m2 IV on Days 1, 2 of 21 day cycles q 2 months for Cycles 1-8
16190217|NCT01470196|Drug|Rituximab|375 mg/m2 IV on Days 2, 9 of 21 day cycles for Cycles 1-6 375 mg/m2 IV on Day 2 of 21 day cycles q 2 months for Cycles 1-8
16190218|NCT01470170|Drug|Alfentanil|Give Alfentanil before TCI Propofol sedative bronchoscope
16190219|NCT01470170|Drug|Normal saline|Normal Saline (placebo comparator) was given in equivalent amount of alfentanil dosage in each arm, for double blinded purpose.
16190220|NCT01470170|Device|Targeted controlled infusion|The Propofol dosage was according to the effect site concentration to reach OAAS-3 ( loss of conscious), using Schneider model
16190221|NCT01470170|Drug|Propofol|The Propofol dosage is according to the effect site concentration to reach OAAS-3 ( loss of conscious), using TCI Schneider model during the whole procedure of bronchoscope
16190222|NCT01470157|Drug|Ketamine|5mg/kg as oral suspension
16190223|NCT01470157|Drug|Normal Saline|Normal Saline (placebo) in addition to Midazolam 0.5mg/kg as oral suspension
16190224|NCT01470144|Drug|Epoprostenol|Administered by continuous intravenous infusion via a central venous catheter; using an ambulatory infusion pump. The dose and infusion rate of EFI may be adjusted throughout the study in order to balance tolerability and maximum clinical benefit
16190225|NCT01470131|Drug|Masitinib|Masitinib 6 mg/kg/day
16190226|NCT01470131|Drug|Placebo|Matching placebo
16190227|NCT01470131|Drug|Bortezomib|Standard therapy (cycles of bortezomib)
16190228|NCT01470131|Drug|Dexamethasone|Standard therapy (cycles of dexamethasone)
16190229|NCT01470118|Drug|alcaftadine 0.25% ophthalmic solution|One drop of alcaftadine 0.25% ophthalmic solution instilled in each eye at Day 0 and Day 14.
16190230|NCT01470118|Drug|olopatadine 0.2% ophthalmic solution|One drop of olopatadine 0.2% ophthalmic solution instilled in each eye at Day 0 and Day 14.
16190231|NCT01470118|Drug|dextran 70 0.1%/hydroxypropyl methylcellulose 0.3%|One drop of placebo instilled in each eye at Day 0 and Day 14.
16190232|NCT01470105|Other|blood sampling, the SF-36 questionnaire|"The patient be asked to fill out a questionnaire. The questionnaire asks about their quality of life and will take approximately 15 minutes to complete. It will be completed at a regularly scheduled clinic visit.
~At the scheduled pre-operative testing, an extra sample of your blood (equal to about 4 teaspoons) will be collected for research tests. The research tests will measure levels of inflammation in your body. These tests are not part of routine care. A physical examination of the operative site will be done by the Orthopaedic Surgeon. The patient will complete the same questionnaire at the regularly scheduled three and six month follow-up visit"
16190233|NCT01470092|Drug|Tibolone|Subjects will take 2.5mg of oral Tibolone daily for the duration of the 12 week trial either alone or in adjunct to currently prescribed antidepressant medication.
16190234|NCT01470053|Drug|mometasone furoate plus azelastine HCl|
16190235|NCT01470053|Drug|mometasone furoate|
16190236|NCT01470053|Drug|azelastine HCl|
16190237|NCT01470040|Drug|discontinuation of aspirin therapy|discontinuation of aspirin therapy
16190238|NCT01470040|Drug|continuation of aspirin therapy|continuation of pre-injury low dose aspirin therapy as per previous medical indication
16190239|NCT01470027|Drug|N-acetylcysteine|900mg NAC effervescent tablets
16190240|NCT01470027|Drug|Placebo|effervescent tablets
16190241|NCT01470001|Drug|solifenacin|patient will receive solifenacin 5mg daily or placebo daily
16190242|NCT01469988|Drug|Testosterone|Patients will be dosed accordingly: Female: 0.3g once daily (or matching placebo) gel;Males: 5g once daily (or matching placebo) gel.
16190308|NCT01469429|Drug|chemoprevention|Receive LBR Saliva Substitute PO
16190309|NCT01469429|Other|placebo|Receive Saliva Substitute placebo PO
16190243|NCT01469975|Drug|OTSA101-DTPA-90Y level 1|Part 2 of the study 1.5 mg of OTSA101-DTPA radiolabelled with 370MBq of 90Y will be administered IV as a single injection on Day 0.
16190244|NCT01469975|Drug|OTSA101-DTPA-90Y level 2|Part 2 of the study 1.5 mg of OTSA101-DTPA radiolabelled with 1110 MBq of 90Y will be administered IV as a single injection on Day 0.
16190245|NCT01469975|Drug|OTSA101-DTPA-90Y level 3|"Part 2 of the study 3 mg of OTSA101-DTPA radiolabelled with 2220 MBq of 90Y will be administered IV as a single injection on Day 0.
~This third dose level evaluation will be based on safety and preliminary efficacy data."
16190246|NCT01469949|Other|Watching or imagining movement|Mental imagery are administered in two forms : kinesthetic when subjects imagine the movement of flexion and extension of the lumbar spine and Visual when subjects watch a video of a third person doing the flexion and extension movement
16190247|NCT01469936|Dietary Supplement|PERMEAPROTECT|"Composition : glutamine, curcuma, zinc, chitosan, beta carotene, Green Tea polyphenols, thiamine and folic acid.
~Duration : 5 weeks +/- 1 week.
~Dosage :
~First Week of intervention : 1/2 stick per day
~Second to 5th Week : 1 stick per day"
16190248|NCT01469936|Dietary Supplement|PLACEBO|"Duration : 5 weeks +/- 1 week.
~Dosage:
~First Week : 1/2 stick per day
~Second to 5th Week : 1 stick per day"
16190249|NCT01469923|Drug|AZD2820|Ascending subcutaneous injections of AZD2820 once daily for 14 days in the abdomen
16190250|NCT01469923|Drug|Placebo|Ascending subcutaneous injections of placebo for AZD2820 once daily for 14 days in the abdomen
16190251|NCT01469910|Drug|Simotinib Hydrochloride|Single ascending doses: 25 mg、50 mg、100 mg、150 mg、225 mg、300 mg、400 mg、500 mg、600 mg、750 mg
16190252|NCT01469910|Drug|Placebo|Single ascending doses: 150 mg、225 mg、300 mg、400 mg、500 mg、600 mg、750 mg
16190253|NCT01469884|Drug|Everolimus|The conversion will be performed abruptly for all patients. Calcineurin inhibitor will be discontinued one day before the day of conversion (Day 1). Everolimus will be introduced on day 1 at dose of 3 mg/d (1,5mg bid), and then everolimus trough levels will be adjusted to achieve 6-10 ng/ml.
16190254|NCT01469884|Drug|Cyclosporine|Trough level should be between 100 and 200ng/ml.
16190255|NCT01469884|Drug|Tacrolimus|Trough level should be between 5 and 10ng/ml.
16190256|NCT01469871|Device|Dressing of wound|The wound will be dressed using the Hypafix Transparent dressing after hip surgery.
16190257|NCT01469871|Device|Dressing of wound|The wound will be dressed using the Mepore Pro dressing after hip surgery.
16190258|NCT01469871|Device|Dressing of wound|The wound will be dressed using the Mepilex Border dressing after hip surgery.
16190259|NCT01469858|Device|Siemens magnetom avanto1.5 Tesla, Siemens magnetom trio A Tim system 3 Tesla|functional magnetic resonance imaging
16190260|NCT01469845|Device|3% hypertonic saline|4 ml dose to be administered every 6 hours
16190261|NCT01469832|Biological|MA09-hRPE|"Cohort 1 50,000 cells
~Cohort 2 100,000 cells
~Cohort 2a Better Vision 100,000 cells
~Cohort 3 150,000 cells
~Cohort 4 200,000 cells"
16190262|NCT01469819|Drug|Lubiprostone|24 mcg twice a day (BID) for 2 weeks.
16190263|NCT01469806|Device|Zimmer Gender Solutions PFJ Knee Prosthesis|Partial knee arthroplasty of the patello-femoral joint
16190264|NCT01469793|Drug|DMOT4039A|DMOT4093A will be administered by intravenous infusion on either a Q3W or a Q1W dosing schedule, in 21-day cycles.
16190265|NCT01469767|Drug|Fluocinonide cream|Fluocinonide cream 0.1% applied twice daily for 5 days.
16190266|NCT01469741|Behavioral|Prospective Memory Strategy|Prospective memory is central to performance in everyday life as it serves to bind together goal-directed actions and enables people to carry out their plans and wishes meaningfully and appropriately. Everyday prospective memory tasks include remembering to run errands, keep appointments, and turn off the stove after using it.
16190267|NCT01469728|Procedure|Non-awake VATS talc pleurodesis|Thoracoscopic talc pleurodesis performed through sole general anesthesia and one-lung ventilation
16190268|NCT01469728|Procedure|Awake VATS talc pleurodesis|Thoracoscopic talc pleurodesis performed in awake patients through sole thoracic epidural anesthesia.
16190269|NCT01469715|Device|GBP CGM|Visit 1: Screening visit to determine if subject qualifies for the study. Visit 2: Inpatient admission requiring a 25.5-hour hospital stay. Each subject will wear one active & one mock device simultaneously during hyperglycemic & hypoglycemic challenge conditions to observe a wide range of glucose values. Visit 3 & 4: Subjects will return to the research center approximately 24 & 48 hours after sensor removal, respectively, for evaluation of the postimplantation sensor site. Visit 5: Subjects will return to the research center approximately 28 days post inpatient admission. Blood samples for future testing of GBP and polyethylene Glycol neutralizing antibodies will be taken at Visit 1 & 5.
16190270|NCT01469702|Drug|prednison and azithromycin|Patients with typical cat-scratch disease will be treated with a 5-day course of prednison and azithromycin.
16190271|NCT01469702|Drug|prednison, azithromycin|Cap Azithromycin 500 mg qd (first day), then 250 mg qd for 4 days and Tab prednison 1 mg/kg/day, not exceeding 60 mg/day, qd, for 5 days.
16190272|NCT01469702|Drug|prednison, Azenil|Cap Azenil 500 mg qd (first day), then 250 mg qd for 4 days and Tab prednison 1 mg/kg/day, not exceeding 60 mg/day qd, for 5 days.
16190273|NCT01469689|Other|Google Adwords|The investigators will display Google Adwords advertising the investigators' website offering online help for depression
16190274|NCT01469689|Other|Local organisation websites|The investigators will place adverts on local organization websites with links to the investigators' project website offering online help for depression
16190275|NCT01469676|Device|Filtering group LG-6, Pall Biomedical Products|In Filtering group, a Leukocyte filter (LG-6, Pall Biomedical Products) was placed on the CPB arterial line circuit, trying to filter the white blood cells.
16190276|NCT01469650|Dietary Supplement|cholecalciferal|400 IU/day
16190277|NCT01469650|Dietary Supplement|cholecalciferol|800 IU/day D3
16190278|NCT01469637|Drug|sulfamethoxazole + MMX placebo|800 mg sulfamethoxazole/160 mg trimethoprim twice daily (BID) + MMX Mesalazine/mesalamine placebo once daily (QD) orally for 3 days, then a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + single does of MMX Mesalazine/mesalamine placebo orally on Day 4.
16190279|NCT01469637|Drug|Sulfamethoxazole + MMX Mesalazine/mesalamine|800 mg sulfamethoxazole/160 mg trimethoprim BID + 4.8 g MMX Mesalazine/mesalamine QD for 3 days, then a single dose of 800 mg sulfamethoxazole/160 mg trimethoprim + a single dose of 4.8 g MMX Mesalazine/mesalamine on Day 4
16190280|NCT01469624|Drug|Pentoxifylline|pentoxifylline 400 mg PO three times a day for 24 hours before and 24 hours after PCI
16190281|NCT01469611|Biological|JX-594|Infusion Procedure:JX-594 will be administered on the designated treatment days at a dose of either 1 x 106, 1 x 107 or 3 x 107 pfu per kg. Virus infusion should occur over 60 minutes (+/- 5 minutes). The final infusion volume of virus plus diluent will be approximately 250 mL.
16190282|NCT01469598|Drug|Gemcitabine/Docetaxel|Gemcitabine 1000 mg/m2 IV over 10 mg/m2/min Docetaxel 35 mg/m2 IV over 1hr every 21 days
16190283|NCT01469585|Drug|Doxycycline|40 mg orally at the start of cycle 3 (study day 57) for 28 days.
16190284|NCT01469572|Drug|Pasireotide|Pasireotide is given as an injection.
16190285|NCT01469572|Procedure|Sir-sphere Radioembolization|A catheter will be placed in a branch of the hepatic artery (liver) that supplies the tumor with blood. Radioactive beads will be injected into the tumor through the catheter.
16190286|NCT01469572|Drug|Everolimus|Given orally every day for the duration of the study
16190287|NCT01469559|Drug|Novolin Toronto insulin|Subjects randomized to active drug are provided with 20 IU BID of Novolin Toronto at randomization (week 5). The dosing is prescribed to be taken 30 minutes after the morning meal (breakfast) and 30 minutes after the evening meal (supper). Subjects are asked to consume their meals and take their doses of study treatment within the same time frame each day. Dose escalations occur every 2 weeks with the insulin increasing to 40 IU BID at week 7, then 80 IU BID at week 9. The study completes at week 11. The total treatment period is 6 weeks. The insulin is diluted with an amount of normal saline to provide a total volume in the study treatment vial to equal 1.1 milliliters.
16190288|NCT01469559|Drug|Normal saline|Subjects randomized to placebo are provided with 1.1 milliliters of normal saline at randomization (week 5). The study completes at week 11. The total treatment period is 6 weeks. The dosing is prescribed to be taken 30 minutes after the morning meal (breakfast)and 30 minutes after the evening meal (supper). Subjects are asked to consume their meals and take their doses of study treatment within the same time frame each day. The amount of normal saline in the study treatment vial (1.1 milliliters) is identical in volume to the active insulin being used in the study .
16190289|NCT01469546|Drug|Axitinib (AG-013736)|The subjects will be started on treatment with 5 mg of Axitinib twice a day continuously, with subsequent dose escalation to 7 mg and then 10 mg twice a day in the absence of grade 2 or worse toxicities. This will be followed by clinical and/or radiologic response assessment after 8 weeks and subsequently every 2 months until disease progression (defined per RECIST [Response Evaluation Criteria In Solid Tumors] criteria, or obvious progression on clinical or laryngoscopic/endoscopic exam) or intolerable toxicity (defined as below). During treatment on this protocol, all patients will be evaluated for safety. Correlative biomarker analysis will also be conducted.
16190290|NCT01469533|Other|Spinal mechanical manipulation intervention|Subjects in experimental group are assessed through use of the Activator Methods (AM) assessment protocol. Spinal adjustment of the indicated pelvis, sacrum and lumbar spine is performed through the use of spinal mechanical manipulation. In this study leg length analysis only uses Position #1 and Position #2. Mechanical manipulation is delivered with the Activator Ⅳ Adjusting Instrument (AAI Ⅳ; Activator Methods International, Ltd, Phoenix, AZ) set in the maximal force setting 4, as it is used in routine clinical practice. The Activator Ⅳ delivers a very short duration (<5 ms) force-time impulse with a peak force magnitude of approximately 176N.
16190291|NCT01469533|Other|Sham manipulation intervention|Subjects in the control group receive a protocol identical to that described above, with the following exception: a sham mechanical thrust is delivered during the AM protocol. The sham procedure is accomplished by setting the expansion control knob on the Activator Ⅱ to the zero (off) position. The expansion control is used to adjust the spring compression and thus the amount of excursion of the instruments' stylus. In the zero position, no excursion of the stylus occurs, although the same clicking sound that the instrument produces during normal use is heard after manual activation of the mechanical trigger.
16190292|NCT01469520|Drug|Epivir®, Retrovir® and Viramune®|12 mL of Epivir® (lamivudine) 10 mg/mL solution plus 24 ml of Retrovir® (zidovudine) 10 mg/mL syrup plus and 20 mL of Viramune® (nevirapine) of 10 mg/mL
16190293|NCT01469520|Drug|Lamivudine, Zidovudine and nevirapine|20 mL of reconstituted granules for suspension containing lamivudine 30mg/zidovudine 60 mg/nevirapine 50 mg per 5 mL of suspension
16190294|NCT01469520|Drug|Lamivudine, zidovudine, nevirapine|Lamivudine 30mg/zidovudine 60 mg/nevirapine 50 mg per tablet.
16190295|NCT01469507|Device|Chondroitin sulfate and sodium hyaluronate|3 weekly injections
16190296|NCT01469507|Drug|Hyaluronan|3 weekly injections
16190297|NCT01469494|Procedure|DIEP flap breast reconstruction|DIEP stands for deep inferior epigastric perforator. This is the name of the main blood vessel that runs through the abdominal tissue that will be used to reconstruct the breast. In DIEP flap reconstruction, only skin, fat, and blood vessels are removed from the lower belly (the abdomen between the waist and hips). No muscle is removed.
16190298|NCT01469494|Procedure|SIEA flap breast reconstruction|"The SIEA flap is very similar to the DIEP flap procedure. Both techniques use the lower abdominal skin and fatty tissue to reconstruct a natural, soft breast following mastectomy.
~The main difference between the SIEA flap and the DIEP flap is the artery used to supply blood flow to the new breast. The SIEA blood vessels are found in the fatty tissue just below skin whereas the DIEP blood vessels run below and within the abdominal muscle (making the surgery more technically challenging). While the surgical preparation is slightly different, both procedures spare the abdominal muscle and only use the patient's skin and fat to reconstruct the breast."
16190299|NCT01469481|Drug|PF-04991532|a single oral dose of [14C]PF-04991532 (450 mg/100 uCi suspension)
16190300|NCT01469468|Drug|Simvastatin|Day 1: Single dose of simvastatin 20 mg Day 8: single dose of simvastatin 20 mg (with PF-05175157)
16190301|NCT01469468|Drug|PF-05175157|Days 2-9 inclusive: daily dosing of PF-05175157 200 mg
16190302|NCT01469455|Drug|DT01|"DT01 starting dose will be 16 mg and it is planned to be increased to 32, 48 mg and 64 mg, or higher.
~DT01 will be administered 3 times a week (e.g., Mondays, Wednesdays and Fridays) over 2 weeks (6 administrations of DT01 in total) at least 3 hours prior to the radiotherapy sessions."
16190303|NCT01469442|Procedure|External Biliary duct stent in the bile duct by cystic way|The size of the external biliary duct stent depending of cystic duct size
16190304|NCT01469429|Other|placebo|Receive lozenge placebo PO
16190305|NCT01469429|Other|laboratory biomarker analysis|Correlative studies
16190306|NCT01469429|Other|questionnaire administration|Ancillary studies
16190307|NCT01469429|Drug|chemoprevention|Receive LBR lozenge PO
16190312|NCT01469403|Behavioral|8 weeks weight loss program, Cambridge.|Fast weight losses improve the prognosis for the sustained weight loss. During the first week a dietitian will tutor the participants in formula food diet (The Cambridge Health and Weight plan UK.), followed by seven weeks with control guidance and instruction in healthy eating habits once a week. The guidance by the dietitian will be carried out both on an individual basis and in groups. The goal of the intervention is to achieve a preoperative weight loss of at least 5 to 10% of the patient's body weight, thus improving patient's health before surgery.
16190313|NCT01469377|Drug|Placebo|Placebo was supplied in capsules
16190314|NCT01469377|Drug|Cariprazine|Cariprazine was supplied in capsules.
16190315|NCT01469364|Drug|Aztreonam Lysine for Inhalation (AZLI)|The intervention will involve open label treatment with AZLI inhaled 75mg TID self-administered intermittently for 28 days on study drug and 28 days off study drug over a study period of 5 consecutive months (on/off/on/off/on AZLI)
16190316|NCT01469364|Procedure|Status Post Lung Transplant|Bronchoscopy, pulmonary function testing, and laboratory testing will be performed on a regular basis during study enrollment consistent with each center's usual standard clinical care.
16190317|NCT01469351|Drug|Liraglutide|"Liraglutide (Victoza ®), human GLP-1 analog produced using recombinant DNA technology in saccharomyces cerevisiae. Victoza ® is registered and approved for the treatment of type 2 diabetes.
~Victoza ® stimulates glucose-dependent insulin secretion from β-cells and inhibits glucagon secretion, slows ventricle emptying and reduces body weight and body fat mass by affecting appetite regulation.
~Form of administration: Liraglutide is a clear injection fluid, which comes in a prefilled disposable pen.
~1 ml contains 6 mg of liraglutide in sterile water. There is added disodium phosphate and propylene glycol and the preservative phenol. A filled pen contains 18mg liraglutide in 3ml. NovoFine® needles are used."
16190318|NCT01469351|Drug|non-active study drug|placebo
16190319|NCT01469338|Drug|cabazitaxel|Given IV
16190320|NCT01469338|Drug|prednisone|Given PO
16190321|NCT01469338|Drug|octreotide pamoate|Given IM
16190322|NCT01469338|Other|questionnaire administration|Ancillary studies
16190323|NCT01469338|Drug|octreotide acetate|Given SC
16190324|NCT01469325|Other|Repetitive Transcranial Magnetic Stimulation|We deliver rTMS to the left prefrontal cortex at 120% motor threshold (10 Hz, 4-second train duration, and 26-second intertrain interval) for 37.5 minutes (3000 pulses per session) using a figure-eight solid-core coil
16190325|NCT01469325|Other|Sham rTMS|Sham rTMS using a similar coil with a metal insert blocking the magnetic field and scalp electrodes that delivered matched somatosensory sensations.
16190326|NCT01469312|Other|modified pasta|50 grams carbohydrate as a single breakfast meal
16190327|NCT01469286|Device|TEA|Electroacupuncture at ST36
16190328|NCT01469286|Device|Sham-TEA|Electroacupuncture at sham-points
16190329|NCT01469273|Drug|Mutaflor® Suspension|Application of Mutaflor-Suspension on 10 consecutive days.
16190330|NCT01469260|Other|Pedometer|Pedometer provided, counseling on pedometer use and step recommendations of 10,000 steps per day, handouts given every 4 weeks to encourage exercise
16190331|NCT01469247|Radiation|Radiation Therapy|Starting Dose 24 Gy in 2 Gy fractions.
16190332|NCT01469234|Drug|loratadine|loratadine, one 10 mg tablet, orally
16190333|NCT01469234|Drug|fexofenadine|fexofenadine, one 180 mg tablet, orally
16190334|NCT01469234|Drug|placebo to loratadine|one tablet, orally
16190335|NCT01469234|Drug|placebo to fexofenadine|one tablet, orally
16190336|NCT01469221|Drug|Apaziquone|6 weekly multi-instillation of Apaziquone 4 mg in 40 mL
16190337|NCT01469221|Drug|Placebo|6 weekly multi-instillation of matching placebo in 40mL
16190338|NCT01469182|Biological|SCH 39641|Rapidly dissolving tablet sublingually once daily
16190339|NCT01469182|Drug|Placebo for SCH 39641|Rapidly dissolving tablet sublingually once daily
16190340|NCT01469169|Drug|Iloprost (Ventavis inhaled, BAYQ6256)|2.5 μg or 5.0 μg BAYQ6256 per inhalation session (Inhalation session is to be conducted 6 to 9 times per day with dosing intervals of at least 2 hours.)
16190341|NCT01469156|Drug|ranibizumab 0.5 or 2.0 mg/0.05 cc|ranibizumab (3:1 ratio of 2mg:0.5 mg ranibizumab) administered in three initial monthly doses followed by a 9 month period of criteria-based, as-needed retreatment and 12 month off drug safety follow up.
16190342|NCT01469143|Drug|Faster-acting insulin aspart|Each subject will randomly be allocated to a treatment sequence consisting of 9 dosing visits during which the subject will receive 8 single doses of different formulations. For all investigational medicinal products the dose levels will be 0.2 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin).
16190343|NCT01469143|Drug|insulin aspart|At one of the scheduled visits, the subject will receive a single dose of insulin aspart. The dose level will be 0.2 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin).
16190344|NCT01469130|Drug|MEK162|MEK162 in an oral formulation. It is a film-coated capsule-shape tablets (i.e. caplets).
16190345|NCT01469117|Other|enteral formula|Complete feeding of study enteral formula, route and regimen prescribed by the physician
16190346|NCT01469104|Other|3 day fast|Subjects will fast for 72 hours
16190347|NCT01469104|Other|3 day CHO-free diet|Subjects will receive a carbohydrate-free diet for 72 hours
16190348|NCT01469091|Behavioral|Smoking intervention.|Nicotine replacement therapy and meetings with nurse specialized in smoking intervention.
16190349|NCT01469078|Drug|Monofer®|Single Bolus Injections
16190350|NCT01469065|Drug|PF-04991532|Oral administration of PF-04991532; 25 mg given twice a day (BID) for 14 days
16190351|NCT01469065|Drug|PF-04991532|Oral administration of PF-04991532; 75 mg given twice a day (BID) for 14 days
16190352|NCT01469065|Drug|PF-04991532|Oral administration of PF-04991532; 150 mg given twice a day (BID) for 14 days
16190353|NCT01469065|Drug|PF-0499132|Oral administration of PF-04991532; 300 mg given twice a day (BID) for 14 days
16190354|NCT01469065|Drug|Placebo|Oral administration of PF-04991532 Matching Placebo; given twice a day (BID) for 14 days
16190355|NCT01469052|Drug|AG-013736|Axitinib continuous oral dosing (10 mg once a day, 10 mg twice a day, 20 mg twice a day or 30 mg twice day) in the fed state
16190356|NCT01469052|Drug|AG-013736|Axitinib continuous oral dosing (20 mg twice a day) in the fed state
16190357|NCT01469052|Drug|AG-013736|Axitinib continuous oral dosing (5 mg twice a day) in the fed state
16190359|NCT01469052|Drug|AG-013736|Axitinib continuous oral dosing (5 mg twice a day) in the fasted state
16190360|NCT01469052|Drug|AG-013736|Axitinib continuous oral dosing (2 mg twice a day on the first day of dosing, followed by 5 mg twice a day) in the fasted state
16190361|NCT01469039|Drug|ALKS 9072|Intramuscular (IM) injection, 441 mg or 882 mg given monthly
16190362|NCT01469039|Drug|Placebo|Placebo for IM injection, given monthly
16190363|NCT01469026|Radiation|PET/CT or Conventional diagnostics including CT|"Radiation:
~PET/CT. 4 MBq/kg (max. 400 MBq) 18F-flour-deoxyglucosegiven iv. 60 min. before PET/CT scan.
~CT. iv.contrast medium (Ultravist 370 mg I/ml)."
16190364|NCT01469013|Drug|Placebo|
16190365|NCT01469013|Drug|Baricitinib|
16190366|NCT01469013|Drug|Baricitinib|
16190367|NCT01469013|Drug|Baricitinib|
16190368|NCT01469013|Drug|Methotrexate|Administered orally as background therapy
16190369|NCT01469000|Drug|Gefitinib|250 mg orally once per day. Number of cycles until disease progression or unacceptable toxicity develops.
16190370|NCT01469000|Drug|Pemetrexed|500 mg/m² IV on day 1 of each 21 day cycle. Number of cycles until disease progression or unacceptable toxicity develops.
16190371|NCT01468987|Drug|LY2605541|
16190372|NCT01468987|Drug|Insulin Glargine|
16190373|NCT01468987|Drug|Insulin Lispro|
16190374|NCT01468974|Device|ESPRIT BVS|Subjects receiving ESPRIT BVS for the treatment of symptomatic claudication from occlusive vascular disease of the superficial femoral (SFA) or common or external iliac arteries
16190375|NCT01468961|Behavioral|Internet-based CBT|10 weeks of internet-based CBT with online therapist contact
16190376|NCT01468948|Drug|Octanoic Acid|
16190377|NCT01468922|Drug|Pazopanib|VEGFR inhibitor
16190378|NCT01468922|Drug|ARQ 197|MET inhibitor
16190379|NCT01468909|Other|Laboratory Biomarker Analysis|Correlative studies
16190380|NCT01468909|Drug|Paclitaxel|Given IV
16190381|NCT01468909|Drug|Pazopanib Hydrochloride|Given PO
16190382|NCT01468909|Other|Placebo|Given PO
16190383|NCT01468896|Biological|Cetuximab|Given IV
16190384|NCT01468896|Biological|Edodekin alfa|Given SC
16190385|NCT01468896|Other|Laboratory Biomarker Analysis|Correlative studies
16190386|NCT01468883|Procedure|M|Modified radical mastectomy
16190387|NCT01468883|Radiation|X|Excisional biopsy plus radiation
16190388|NCT01468844|Drug|Minocycline|100 mg pink opaque capsule
16190389|NCT01468844|Drug|Placebo|Placebo
16190390|NCT01468844|Drug|Bevacizumab|1.25 mg bevacizumab injection
16190391|NCT01468831|Drug|Minocycline|100 mg pink opaque capsule
16190392|NCT01468831|Other|Placebo|Pill with inactive ingredients in a pink opaque capsule
16190393|NCT01468818|Drug|Cyclophosphamide|Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg/day X 2 days over 1 hr.
16190394|NCT01468818|Drug|Fludarabine|Fludarabine 25 mg/m2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
16190395|NCT01468818|Biological|Young Tumor Infiltrating Lymphocytes (TIL)|Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of young TIL. On day 0, cells (1x10e9 to 2x10e11) will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes (between one and four days after the last dose of fludarabine).
16190396|NCT01468805|Procedure|Cockroach mitigation/extermination|
16190397|NCT01468779|Dietary Supplement|Probiotics|The probiotics pills are given orally in the amount of two pills twice a day as early as two days before surgery until ten days after surgery.
16190398|NCT01468779|Dietary Supplement|Sugar pill|
16190399|NCT01468766|Other|Supervised progressive resistance training|2x60 minutes per week for 12 weeks
16190400|NCT01468766|Other|Supervised progressive muscle relaxation training (Jacobson method)|2x60 minutes per week for 12 weeks
16190401|NCT01468753|Procedure|Vaginal Insemination|Women will perform vaginal insemination during the fertile period with semen within one hour of collection. Vaginal insemination will occur within one hour of collection 2 days prior to ovulation, on the day of ovulation and 2 days after ovulation for up to 6 months or until conception occurs. For example, if ovulation were on day 14 of a 28 day menstrual cycle, vaginal insemination will occur on days 12, 14 and 16 of the cycle.
16190402|NCT01468740|Drug|Doxorubicin|"The four-drug ABVD chemotherapy regimen and the seven-drug BEACOPP-baseline chemotherapy regimen contain doxorubicin.
~Early stage favorable Hodgkin Lymphoma: 2 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) + 30 Gy involved field (IF) radiation
~Early stage unfavorable Hodgkin Lymphoma: 4 cycles of ABVD + 30 Gy involved field (IF) radiation or 4 cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP)-baseline + 30 Gy IF radiation
~Advanced Hodgkin Lymphoma: 8 cycles of BEACOPP-baseline. After the completion of chemotherapy sites of initial bulky disease (those at least 5 cm in diameter) and residual tumor larger than 2.5 cm in diameter receive 30 Gy of irradiation."
16190403|NCT01468740|Drug|Bleomycin|"The four-drug ABVD chemotherapy regimen and the seven-drug BEACOPP-baseline chemotherapy regimen contain bleomycin.
~Early stage favorable Hodgkin Lymphoma: 2 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) + 30 Gy involved field (IF) radiation
~Early stage unfavorable Hodgkin Lymphoma: 4 cycles of ABVD + 30 Gy involved field (IF) radiation or 4 cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP)-baseline + 30 Gy IF radiation
~Advanced Hodgkin Lymphoma: 8 cycles of BEACOPP-baseline. After the completion of chemotherapy sites of initial bulky disease (those at least 5 cm in diameter) and residual tumor larger than 2.5 cm in diameter receive 30 Gy of irradiation."
16190404|NCT01468740|Drug|Vinblastine|"The four-drug ABVD chemotherapy regimen contains vinblastine
~Early stage favorable Hodgkin Lymphoma: 2 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) + 30 Gy involved field (IF) radiation
~Early stage unfavorable Hodgkin Lymphoma: 4 cycles of ABVD + 30 Gy involved field (IF) radiation"
16190405|NCT01468740|Drug|Dacarbazine|"The four-drug ABVD chemotherapy regimen contains dacarbazine
~Early stage favorable Hodgkin Lymphoma: 2 cycles of doxorubicin, bleomycin, vinblastine, and dacarbazine (ABVD) + 30 Gy involved field (IF) radiation
~Early stage unfavorable Hodgkin Lymphoma: 4 cycles of ABVD + 30 Gy involved field (IF) radiation"
16190791|NCT01465880|Other|Part A|Smoking abstinence, smoking 2 and 4 cigarettes
16190406|NCT01468740|Drug|Etoposide|"The seven-drug BEACOPP-baseline chemotherapy regimen contains etoposide.
~Early stage unfavorable Hodgkin Lymphoma: 4 cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP)-baseline + 30 Gy IF radiation
~Advanced Hodgkin Lymphoma: 8 cycles of BEACOPP-baseline. After the completion of chemotherapy sites of initial bulky disease (those at least 5 cm in diameter) and residual tumor larger than 2.5 cm in diameter receive 30 Gy of irradiation."
16190407|NCT01468740|Drug|Cyclophosphamide|"The seven-drug BEACOPP-baseline chemotherapy regimen contains cyclophosphamide.
~Early stage unfavorable Hodgkin Lymphoma: 4 cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP)-baseline + 30 Gy IF radiation
~Advanced Hodgkin Lymphoma: 8 cycles of BEACOPP-baseline. After the completion of chemotherapy sites of initial bulky disease (those at least 5 cm in diameter) and residual tumor larger than 2.5 cm in diameter receive 30 Gy of irradiation."
16190408|NCT01468740|Drug|Vincristine|"The seven-drug BEACOPP-baseline chemotherapy regimen contains vincristine.
~Early stage unfavorable Hodgkin Lymphoma: 4 cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP)-baseline + 30 Gy IF radiation
~Advanced Hodgkin Lymphoma: 8 cycles of BEACOPP-baseline. After the completion of chemotherapy sites of initial bulky disease (those at least 5 cm in diameter) and residual tumor larger than 2.5 cm in diameter receive 30 Gy of irradiation."
16190409|NCT01468740|Drug|Procarbazine|"The seven-drug BEACOPP-baseline chemotherapy regimen contains procarbazine.
~Early stage unfavorable Hodgkin Lymphoma: 4 cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP)-baseline + 30 Gy IF radiation
~Advanced Hodgkin Lymphoma: 8 cycles of BEACOPP-baseline. After the completion of chemotherapy sites of initial bulky disease (those at least 5 cm in diameter) and residual tumor larger than 2.5 cm in diameter receive 30 Gy of irradiation."
16190410|NCT01468740|Drug|Prednisone|"The seven-drug BEACOPP-baseline chemotherapy regimen contains prednisone.
~Early stage unfavorable Hodgkin Lymphoma: 4 cycles of bleomycin, etoposide, doxorubicin, cyclophosphamide, vincristine, procarbazine, and prednisone (BEACOPP)-baseline + 30 Gy IF radiation
~Advanced Hodgkin Lymphoma: 8 cycles of BEACOPP-baseline. After the completion of chemotherapy sites of initial bulky disease (those at least 5 cm in diameter) and residual tumor larger than 2.5 cm in diameter receive 30 Gy of irradiation."
16190411|NCT01468727|Dietary Supplement|xylitol wipe|Parents were instructed to wipe their infants' teeth and gums three times per day with two wipes each time after feeding in addition to their daily tooth brushing.
16190412|NCT01468727|Dietary Supplement|placebo wipe|Parents were instructed to wipe their infants' teeth and gums three times per day with two wipes each time after feeding in addition to their daily tooth brushing.
16190413|NCT01468714|Drug|PF-04937319 / ketoconazole|Single 20 mg dose of PF-04937319 on day 1, multiple dose of ketoconazole 200 mg twice daily from day 3 to 7, single 20 mg dose of PF-04937319 on day 6
16190414|NCT01468688|Drug|STI571|
16190415|NCT01468688|Drug|BKM120|BKM120 combination therapy
16190416|NCT01468675|Other|Intervention|risk assessment survey; decision support for providers for prevention based on risk
16190417|NCT01468649|Device|NIR Imaging with FLARE and Mini-FLARE Imaging System|A custom-designed imaging platform that utilizes NIR fluorescence optics will be employed to identify the injected dye and its path through the lymphatic track, and its eventual highlighting of the SLN. Both color images and NIR images will be merged to give the operating surgeon a clear picture of the ICG track superimposed over anatomical landmarks. This technique will identify the SLN and provide an accurate video image of its location.
16190418|NCT01468636|Drug|Oral Zinc|200 mg BID of oral zinc gluconate x 8 weeks
16190419|NCT01468636|Drug|Placebo|200mg BID x 8 weeks
16190420|NCT01468623|Other|Pharmacokinetic 5-FU dose adjustment using OnDose® assay|OnDose is a commercially available assay to measure concentration of 5-FU exposure.
16190421|NCT01468623|Other|Standard of care|Patients' dose of 5-FU will be based on Body Surface Area (BSA).
16190422|NCT01468610|Drug|desvenlafaxine|50-100 mg daily for 8 weeks
16190423|NCT01468584|Drug|MP-424 (generic name:Telaprevir)|750mg q8h for 12 weeks
16190424|NCT01468584|Drug|Ribavirin|400 - 1000 mg/day based on body weight for 24 weeks
16190425|NCT01468584|Drug|Peginterferon alfa-2b|1.5mcg/kg/week for 24 weeks
16190426|NCT01468571|Drug|Spironolactone|50 mg po daily of spironolactone for 8 weeks. A cross-over study where each subject will receive spironolactone or placebo in a random order for 8 weeks each.
16190427|NCT01468571|Drug|Placebo|"Each subject will receive placebo or spironolactone for 8 weeks. At the end of week 8, treatment arm for each subject will be blindly switched.
~So if a study patient received placebo for the first 8 weeks then he/she will be switched to receive active drug (spironolactone) for the next 8 weeks."
16190428|NCT01468558|Drug|MAP0004|MAP0004 1.0mg via inhalation on Day 1 and Day 6 of Visit 2
16190429|NCT01468558|Drug|IV DHE|IV DHE (Intravenous Dihydroergotamine Mesylate) administered at Visit 3
16190430|NCT01468558|Drug|Ketoconazole|Ketoconazole 400 mg administered once a day on days 3-6 of Visit 2
16190431|NCT01468545|Other|Iloprost (Ventavis inhaled, BAYQ6256)|An extra educational reinforcement at baseline and at 6 months will be given to a group of patients
16190432|NCT01468545|Other|Iloprost (Ventavis inhaled, BAYQ6256)|No extra educational reinforcement.
16190433|NCT01468532|Drug|docetaxel|Given IV
16190434|NCT01468532|Drug|pasireotide|Given IM
16190435|NCT01468532|Drug|prednisone|Given PO
16190436|NCT01468519|Drug|Insulin|Insulin via continuous subcutaneous insulin infusion
16190437|NCT01468519|Drug|Insulin|insulin via multiple daily injections
16190438|NCT01468480|Drug|Pro Root MTA|application of MTA in second group and 24 hour interval before restoration
16190439|NCT01468480|Drug|Pro Root MTA- single visit|application of MTA in third group and 15 minute interval before restoration
16190440|NCT01468480|Drug|MultiCal|application of Multical in forth group as a pulp dressing agent
16190441|NCT01468480|Drug|Dycal|application of Dycal in first group as a pulp dressing agent
16190442|NCT01468467|Drug|AC220|Oral Liquid
16190443|NCT01468454|Drug|18 F-DOPA|1 time injection of 0.08 - 0.16 mCi/kg of 18F-DOPA
16190444|NCT01468441|Drug|Triptorelin|Triptorelin (0.1 mg, Gonapeptyl® Daily; Ferring, Kiel, Germany) in alternate-days from Day 1 of the menstrual cycle until the day of hCG administration.
16193780|NCT01443182|Behavioral|MPE|Modified prolonged exposure (MPE)
16190445|NCT01468441|Drug|Cetrorelix|When patients presented at least two follicles ≥ 14mm upon scan on days 7- 9, GnRH antagonist (cetrorelix, 0.25 mg/day, Cetrotide®; EMD Serono, Inc, Rockland, MA, USA) administration is started and continued until hCG administration.
16190446|NCT01468415|Drug|phenol|1 cc of 8% phenol dissolved in water or 20cc of 8o mg Methylprednisolone diluted in 0.25% marcaine.
16190447|NCT01468402|Procedure|Magnetic Resonance Image|The leiomyomas were evaluated individually. MR was used to evaluate morphology: the radiological dimension(s) of the leiomyoma and uterus and the volume. The number of leiomyoma fibroids was determined, and their location in the myometrium. Perfusion and the characterization of the T2 signal were also evaluated.
16190448|NCT01468389|Drug|Capecitabine|900-1000mg/m2 bid, days 1-14, every 3 weeks
16190449|NCT01468389|Drug|capecitabine|Dosing schedule: 900-1000mg/m2 bid, days 1-14, every 3 weeks Maintenance dosing schedule: 1000-1250mg/m2 bid, days 1-14, every 3 weeks
16190450|NCT01468376|Dietary Supplement|GLU-01|14 day dosing
16190451|NCT01468376|Dietary Supplement|GLU-02|14 day dosing
16190452|NCT01468376|Dietary Supplement|GLU-03|14 day dosing
16190453|NCT01468376|Dietary Supplement|GLU-04|14 day dosing
16190454|NCT01468376|Dietary Supplement|GLU-05|14 day dosing
16190455|NCT01468376|Dietary Supplement|GLU-06|14 day dosing
16190456|NCT01468363|Device|Dry weight adjustment|Dry weight adjustment according to BCM results
16190457|NCT01468350|Drug|dalfampridine-ER 10mg|
16190458|NCT01468350|Other|Placebo|
16190459|NCT01468337|Drug|Interferon gamma-1b|"Participant 1: 2 drops of topical interferon gamma-1b three times daily in the study eye for a daily dose of 42 μg
~Participant 2: 3 drops 3 times daily in the study eye for a daily dose of 63 μg, if the 1st participant's dose is deemed well-tolerated by the investigator at Weeks 1, 2 and 4.
~Participant 3: 3 drops 4 times daily in the study eye for a daily dose of 84 μg, if the 2nd tolerates the daily dose of 63 μg at Weeks 1, 2 and 4.
~Participants 4 and 5: 4 drops 4 times daily in the study eye for a daily dose of 112 μg, if the 3rd tolerates the daily dose of 84 μg at Weeks 1, 2 and 4.
~If the 63, 84 or 112 μg doses are not well-tolerated, subsequent participants will be enrolled at the prior dose level (42, 63 or 84 μg). Well-tolerated is defined as no corneal irritation (e.g., punctuate epithelial keratitis), no coexisting conjunctival erythema and edema, and no signs of more serious toxicities (e.g., intraocular inflammation or lens changes)."
16190460|NCT01468324|Drug|AZD7451|Depending on dose level, AZD7451 will be given once daily for 28 day cycles.
16190461|NCT01468311|Procedure|Auto stem cell transplant|Auto stem cell transplant (ASCT) is given after 90Y-daclizumab
16190462|NCT01468311|Drug|BEAM|BCNU, etoposide, cytarabine and melphalan (BEAM) chemotherapy are given after 90Y-daclizumab
16190463|NCT01468311|Radiation|111In-daclizumab|111In-daclizumab will be administered to patients with each therapeutic infusion of 90Y-daclizumab in order to define the distribution of radiolabeled daclizumab, and to allow visualization by scans.
16190464|NCT01468311|Radiation|90Y-daclizumab|90Y-daclizumab administered with a fixed dose of pentetate calcium trisodium (Ca-DTPA) followed by BEAM Chemo and Auto stem cell transplant
16190465|NCT01468298|Other|Isostretching|All of patients were accompanied by an individual treatment program composed by 12 sessions of 45 minutes, twice a week. The Isostretching method includes therapeutic different postures, lying, sitting or standing, and the positions were selected according to the postural changes of each patient, identified in the assessment. The Isostretching protocol involves nine positions held for a period of nine breaths, and every three cycles, the patient should rest for a period. The physical therapist used verbal commands to emphasize pursed lip breathing, self growth, curvatures correction and isometric of abdominal, paravertebral, quadriceps and gluteal muscles with the aim of optimizing the stretching and discouraging compensatory movements.
16190466|NCT01468298|Other|Global Posture Reeducation|All patients were accompanied by an individual treatment program composed by 12 sessions of 45 minutes, twice a week, involving a series of active gentle movements and postures aimed at realigning joints, stretching shortened muscles and enhancing the contraction of antagonist muscles, thus avoiding postural asymmetry. The positions were selected according to the postural changes of each patient, identified in the assessment and these therapeutic postures imply an active involvement of the patient. The protocol includes three therapeutic postures, lying, sitting or standing, to be held for 15 minutes each. The physical therapist used verbal commands and manual contact to maintain the alignment and make the necessary postural corrections, with the aim of discouraging compensatory movements.
16190467|NCT01468285|Drug|betahistine dihydrochloride|betahistine dihydrochloride 24 mg tablet b.i.d. six weeks treatment
16190468|NCT01468285|Other|placebo|placebo tablets b.i.d., six weeks treatment
16190469|NCT01468272|Drug|free comb. beclomethasone DPI and formoterol DPI|free combination of beclomethasone dipropionate 100 ug/unit DPI (two inhalations, total dose 200 ug), and formoterol fumarate 6 ug/unit DPI (four inhalations, total dose 24 ug).
16190470|NCT01468272|Drug|CHF 1535 50/6 NEXT DPI|four inhalations of CHF 1535 50/6 NEXT DPI, a fixed combination of beclomethasone dipropionate 50 ug plus formoterol fumarate 6 ug (TOTAL DOSE:BDP/FF 200/24 ug)
16190471|NCT01468259|Drug|Droxidopa|The dose to be used is a single 600 mg dose (2 x 300 mg capsules) of droxidopa.
16190472|NCT01468233|Biological|adalimumab|Adalimumab pre-filled syringe, administered by subcutaneous injection
16190473|NCT01468233|Biological|placebo|Placebo pre-filled syringe, administered by subcutaneous injection
16190474|NCT01468220|Other|Endurance training|Endurance training three times per week over six weeks
16190475|NCT01468207|Biological|adalimumab|Adalimumab pre-filled syringe, administered by subcutaneous injection
16190476|NCT01468207|Biological|placebo|Placebo pre-filled syringe, administered by subcutaneous injection
16190477|NCT01468194|Other|Breathing procedure 1|inhalation during one step, exhalation during the next step
16190478|NCT01468194|Other|Breathing procedure 2|inhalation and exhalation during one step
16190479|NCT01468181|Drug|LY2189265|
16190480|NCT01468181|Drug|Sulfonylureas (SU)|SU is a pre-study prescribed dose and is not being provided as part of the trial.
16190481|NCT01468181|Drug|Biguanides (BG)|Biguanides is a pre-study prescribed dose and is not being provided as part of the trial.
16190482|NCT01468181|Drug|alpha-glucosidase inhibitor (a-GI)|a-GI is a pre-study prescribed dose and is not being provided as part of the trial.
16190483|NCT01468181|Drug|Thiazolidinedione (TZD)|TZD is a pre-study prescribed dose and is not being provided as part of the trial.
16190484|NCT01468181|Drug|Glinides|Glinides is a pre-study prescribed dose and is not being provided as part of the trial.
16190485|NCT01468168|Drug|DE-101 Ophthalmic Suspension|Ophthalmic suspension; QID
16190486|NCT01468168|Drug|DE-101 Ophthalmic Suspension|Ophthalmic suspension; QID
16190487|NCT01468168|Drug|DE-101 Ophthalmic Suspension Vehicle|Ophthalmic suspension vehicle; QID
16190488|NCT01468155|Drug|dabigatran|30 days pre ablation and 90 days post ablation
16190489|NCT01468129|Other|Cell Saver|
16190490|NCT01468103|Procedure|Surgical Iridectomy|Surgical Iridectomy is now widely used in our clinical.
16190491|NCT01468103|Procedure|Laser Iridotomy|alternative choice to surgical iridectomy
16190492|NCT01468077|Drug|Tocilizumab|8 mg/kg infusion
16190493|NCT01468064|Genetic|Autologous BMSCs transplantation|"The first transplantation: 2.5 million cells per kg autologous BMSCs suspended in 100 ml saline plus 5% autologous serum are infused intravenously approximately 4 weeks after bone marrow aspiration.
~The second transplantation: the same amount of cells are again transplanted approximately 1 weeks after initial boosting."
16190494|NCT01468064|Genetic|Autologous EPCs transplantation|"The first transplantation: 2.5 million cells per kg autologous EPCs suspended in 100 ml saline plus 5% autologous serum are infused intravenously approximately 4 weeks after bone marrow aspiration.
~The second transplantation: the same amount of cells are again transplanted approximately 1 weeks after initial boosting."
16190495|NCT01468064|Genetic|IV infusion of placebo|IV infusion of saline plus 5% autologous serum.
16190496|NCT01468051|Biological|four doses of Euvax B vaccine|40 μg (2 ml) four doses of Euvax B vaccine
16190497|NCT01468051|Biological|20 μg (1 ml) three doses of Euvax B vaccine|20 μg (1 ml) three doses of Euvax B vaccine (recombinant hepatitis B surface antigen adsorbed on aluminium hydroxide adjuvant- LG Chem, Korea)
16190498|NCT01468038|Drug|Trazodone|active trazodone and sentra pm-like placebo
16190499|NCT01468038|Other|Sentra PM|Active Sentra PM and trazodone-like placebo
16190500|NCT01468038|Drug|Sentra PM and Trazodone (CoPack Kit Trazamine)|A CoPack Kit - Trazamine, consisting of the co-administration of Sentra PM and trazodone.
16190501|NCT01468038|Drug|Placebo trazodone and placebo Sentra PM|Trazodone-like placebo and Sentra PM-like placebo co-administered as placebo of Trazamine CoPack Kit.
16190502|NCT01468025|Drug|Active Theramine and Active Naproxen|Co-administration of Theramine and Naproxen, CoPack Kit Theraproxen
16190503|NCT01468025|Other|Theramine and naproxen-like placebo|Theramine, a medical food, co-administered with naproxen-like placebo
16190504|NCT01468025|Drug|Naproxen and Theramine-like placebo|naproxen co-administered with Theramine-like placebo.
16190505|NCT01468012|Drug|levodopa carbidopa and entacapone (LCE)|400mg/100mg/200mg, twice daily
16190506|NCT01468012|Drug|Placebo|matched placebo for LCE condition dosed twice daily
16190507|NCT01467999|Drug|Guanfacine|Guanfacine, 4mg given once daily
16190508|NCT01467986|Drug|Dasatinib|Pharmacotherapeutic Group: protein kinase inhibitor ATC-Code: L01XE06 Excipients: Tablet core: Lactose monohydrate, Cellulose, microcrystalline, Croscarmellose sodium, Hydroxypropyl cellulose, Magnesium stearate. Film-coating: Hypromellose, Titanium dioxide, Macrogol 400 Formulation: film coated tablet Route of Administration: orally. Patients should be instructed to swallow the tablets as a whole and not to split, chew, or crush them.
16190509|NCT01467986|Drug|Rapamycin|Pharmacotherapeutic Group: Immunosuppressive agents - mTOR Inhibitors ATC-Code: L04A A10 Excipients: Polysorbat 80, Phosal 50 PG ((3-sn-Phosphatidyl)cholin from Soy beans, Propylenglycol, lipid acid mono- and -diglyzeride from Soy oil, Ethanol (1,5% bis 2,5%), Soy liid acid and Palmitoyl ascorbic acid) Formulation: Oral solution Route of Administration:orally
16190510|NCT01467986|Drug|Irinotecan|Pharmacotherapeutic Group: cytostatic topoisomerase-I-inhibitor ATC-Code: L01XX19 Excipients: Sorbitol (E420), lactic acid, sodium hydroxid (to adjust the pH to 3.5), water for injection Formulation: concentrate for solution for infusion Route of Administration: intravenously
16190511|NCT01467986|Drug|Temozolomide|"Pharmacotherapeutic Group: Antineoplastic agents - Other alkylating agents, ATC-Code: L01A X03 Excipients: Capsule content: Anhydrous lactose, Sodium starch glycolate Type A, Colloida anhydrous silica, Tartaric acid, Stearic acid. Capsule shell: Gelatine, Titanium dioxide (E171).
~Printing ink: Shellac Propylene glycol, Titanium dioxide (E171), Sunset yellow FCF Aluminium Lake (E110) Formulation: capsule, hard Route of Administration: orally; Temomedac hard capsules should be administered in the fasting state. The capsules must be swallowed whole with a glass of water and must not be opened or chewed"
16190512|NCT01467986|Drug|Irinotecan|Pharmacotherapeutic Group: cytostatic topoisomerase-I-inhibitor ATC-Code: L01XX19 Excipients: Sorbitol (E420), lactic acid, sodium hydroxid (to adjust the pH to 3.5), water for injection Formulation: concentrate for solution for infusion Route of Administration: intravenously
16190513|NCT01467986|Drug|Temozolomide|"Pharmacotherapeutic Group: Antineoplastic agents - Other alkylating agents, ATC-Code: L01A X03 Excipients: Capsule content: Anhydrous lactose, Sodium starch glycolate Type A, Colloida anhydrous silica, Tartaric acid, Stearic acid. Capsule shell: Gelatine, Titanium dioxide (E171).
~Printing ink: Shellac Propylene glycol, Titanium dioxide (E171), Sunset yellow FCF Aluminium Lake (E110) Formulation: capsule, hard Route of Administration: orally; Temomedac hard capsules should be administered in the fasting state. The capsules must be swallowed whole with a glass of water and must not be opened or chewed"
16190514|NCT01467947|Biological|Berinert, lyophilizate for IV application containing 500 IU C1-INH to be reconstituted with 10 mL water for injection|Individual treatment duration per subject is 9 months, irrespective of the number of treated attacks. Each attack that occurs in this time frame will be treated with 20 IU Berinert/kg body weight.
16190515|NCT01467921|Drug|oxaliplatin|oxaliplatin 85 mg/m2 will be given intravenously on day 1 for over 2 h
16190516|NCT01467908|Device|Navigated transcranial magnetic brain stimulation|Standard NBS motor mapping using the Eximia TMS stimulator, Nexstim Ltd., Finland.
16190517|NCT01467882|Drug|Triptorelin|Powder and solution for solution for injection
16190556|NCT01467518|Drug|Dolutegravir|Dolutegravir is an experimental drug in the integrase inhibitor class for the treatment of HIV. Dose of 50mg every 12 hours for 5 days.
16190557|NCT01467518|Drug|Methadone|Methadone is a synthetic opioid used in the treatment of opioid dependence. Subjects will be on individualize stabe dose for 8 days.
16190558|NCT01467505|Drug|Telaprevir|Tablet
16190559|NCT01467505|Drug|Ribavirin|Tablet
16190560|NCT01467505|Drug|Pegylated Interferon Alfa-2a|Subcutaneous Injection
16190518|NCT01467856|Procedure|PAP Device Procedure|"Following titration, subjects will be issued a PAP machine programmed at this optimum pressure and instructed to use the device nightly for the ensuing three months. Compliance checks will be conducted at months 1 and 3 by having the subjects present the PAP Smartcard for download and interpretation.
~Daily compliance will be reported as the total number of hours of PAP use per 24 hour period. Patients who use PAP > 4 hours/ night for more than 50% of the nights at one month and 3 month follow-up will be classified as 'compliant' with PAP. Non-compliance will be addressed by a clinical problem-solving approach normally utilized by sleep laboratory personnel in the UM PAP clinic."
16190519|NCT01467843|Behavioral|Cognitive Behavioral Therapy|The Cognitive Behavioral Therapy Intervention will be delivered during 8 weekly classes each lasting 2 hours. The classes will be held at a conveniently located Group Health Facility.
16190520|NCT01467843|Behavioral|Mindfulness Based Stress Reduction|The Mindfulness Based Stress Reduction Classes will be delivered in 8 weekly classes each lasting 2 hours.
16190521|NCT01467830|Procedure|Open Inguinal Hernia Repair With Mesh,the Use of Absorbable Versus Non Absorbable Fixation Sutures|use of absorbable sutures to fixate mesh inguinal hernia repair.
16190522|NCT01467817|Behavioral|Lifestyle Intervention|The intervention incorporates 6 months of active structured lifestyle intervention containing participant education, exercise, dietary intervention, and behavioral support
16190523|NCT01467817|Behavioral|Exercise Control|The control group intervention will test benefits of exercise alone while controlling for investigator contact.
16190524|NCT01467804|Drug|Sertraline plus placebo of JWXYJN|oral sertraline (start with 50 mg/day for one week then continue with 100 mg/day plus placebo of JWXYJN
16190525|NCT01467804|Drug|JWXYJN plus placebo of Sertraline|JWXYJN 3.6g/d plus placebo of sertraline
16190526|NCT01467791|Other|Observation|Observe patients
16190527|NCT01467778|Device|ELAPR|ELAPR implant product is under development for mid to deep dermal implantation for the treatment of the symptoms of skin aging including the correction of moderate to sever facial wrinkles and folds, such as nasolabial folds and skin abnormalities such as scars.
16190528|NCT01467778|Device|ELAPR|Implant area of the medial aspect of the upper arm along the posterior line of the bicep is to be selected where there are no pigmentations or moles. Injections will be marked with a tattoo and placed at 2 cm intervals. The order is to be from proximal to distal control, ELAPR001, ELAPR002, ELAPR003
16190529|NCT01467765|Other|Elental|200Kcal/200mL of liquid nutrient for 15 min at 7:30 am is administered in PEG patients
16190530|NCT01467752|Procedure|MCP joint|reconstruction of metacarpophalangeal (MCP) joint using a bone graft
16190531|NCT01467739|Device|Ambu ® aScope®|
16190532|NCT01467739|Device|a conventional reusable fiberscope|
16190533|NCT01467726|Drug|Velusetrag|Capsules
16190534|NCT01467726|Drug|Velusetrag|Capsules
16190535|NCT01467726|Drug|Placebo|Capsules
16190536|NCT01467713|Drug|Ramelteon SL|Ramelteon sublingual (SL) tablets
16190537|NCT01467713|Drug|Placebo|Ramelteon sublingual (SL) placebo-matching tablets
16190538|NCT01467700|Drug|Ramelteon SL|Ramelteon SL tablets
16190539|NCT01467700|Drug|Placebo|Ramelteon placebo-matching tablets
16190540|NCT01467687|Drug|verapamil controlled release|verapamil 300 mg controlled release capsule as a single dose
16190541|NCT01467661|Drug|SPD422 (anagrelide hydrochloride)|Subjects will be continued on the dose of anagrelide that controlled their platelet levels in Study 308 and titrated if necessary.
16190542|NCT01467648|Drug|Doripenem|"(i) 0.5 g in 100 ml of normal saline solution and administered via an infusion pump at a constant flow rate over 1 h every 8 h.
~Blood samples (approximately 2 ml)will be obtained by direct venepuncture at the following time: 0, 0.5, 1, 2, 3, 4, 4.5, 5, 6, 7 and 8 h after 7th dose of doripenem."
16190543|NCT01467648|Drug|Doripenem|"(ii) 0.5 g in 100 ml of normal saline solution and administered via an infusion pump at a constant flow rate over 1 h every 8 h.
~Blood samples (approximately 2 ml) will be obtained by direct venepuncture at the following time: 1, 1.5, 2, 4, 5, 6, 7 and 8 h after 7th dose of doripenem."
16190544|NCT01467635|Device|Endobronchial ultrasound guided lymph node sampling|Patients with enlarged mediastinal or hilar lymph nodes have these sampled under endobronchial ultrasound guidance using either the EBUS-TBNA needle or the EBUS-TBNB biopsy forceps.
16190545|NCT01467622|Procedure|Chest tube removal|Chest tube removal on the basis of local recommendations for postoperative chest tube management
16190546|NCT01467596|Device|Elderly population, Middle aged population|The study method is a step-up/step-down sequence model where the dose of local anesthetic for the following patient is determined by the outcome of the preceding block. The starting dose of 50:50 mixture of 0.5% levobupivacaine and 2% lidocaine is 30 mL. In the case of block failure, the dose will be increased by 5 mL. Conversely, block success will result in a reduction in dose by 5 mL. A blinded assistant will assess sensory and motor blockade in each nerve territory ( the median, radial, ulnar and musculocutaneous) at 5-min intervals up to 30 min after completion of US-SCB. Effective US-SCB will be defined as complete sensory blockade in the distribution of the radial, ulnar, median and musculocutaneous nerve.
16190547|NCT01467583|Drug|Fondaparinux|2.5 mg every 48 hours
16190548|NCT01467570|Dietary Supplement|oral rehydration solution Hipp ORS Apple 200|"Volume of the solution calculated by weight:
~fast oral rehydration in 3-4 hours by mouth
~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
16190549|NCT01467570|Dietary Supplement|ESPGHAN ORS|"Volume of the solution calculated by weight:
~fast oral rehydration in 3-4 hours by mouth
~ORS given for ongoing losses until diarrhea stops (maintenance phase)"
16190550|NCT01467557|Device|narafilcon B daily disposable soft contact lenses|daily disposable soft contact lenses
16190551|NCT01467557|Device|etafilcon A daily disposable soft contact lenses|daily disposable soft contact lenses
16190552|NCT01467544|Other|Tai Chi class|The 8-week tai chi group intervention will be lead by Project PI. A focused short form of tai chi involving 12 movements will be used in this project. Each of 8 weekly 60-minute sessions will begin with a 10-minute guided meditation session. Movements learned the previous week will be reviewed prior to introducing new movements. Training DVDs will be produced and provided to participants for weekly and ongoing practice of the techniques.
16190553|NCT01467531|Drug|Dolutegravir|50mg q 24h
16190554|NCT01467531|Drug|Rlipivirine|25mg q24h
16190555|NCT01467531|Drug|GSK1265744|30mg q24h
16190651|NCT01466829|Drug|Parathyroid hormone|100 microgram daily. S.c
16190561|NCT01467505|Drug|Immunosuppressant Regimen|Cyclosporine (CsA) based immunosuppressant regimen or Tacrolimus (TAC) based immunosuppressant regimen, as per standard practice. Immunosuppressant regimen were not considered study drugs.
16190562|NCT01467492|Drug|Telaprevir|Tablet
16190563|NCT01467492|Drug|Ribavirin|Tablet
16190564|NCT01467492|Biological|Pegylated Interferon Alfa-2a|Subcutaneous Injection
16190565|NCT01467479|Drug|Telaprevir|Tablet
16190566|NCT01467479|Drug|Ribavirin|Tablet
16190567|NCT01467479|Biological|Pegylated Interferon Alfa-2a|Subcutaneous Injection
16190568|NCT01467479|Drug|Highly Active Antiretroviral Therapy (HAART)|Atazanavir/ritonavir (ATV/r) based HAART, Efavirenz (EFV) based HAART, or Raltegravir (RAL) based HAART, as per standard practice. HAART medications were not considered study drugs.
16190569|NCT01467466|Drug|IV isotonic saline|The investigators will administer 3 ml/kg of isotonic saline over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic saline over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic saline (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure.
16190570|NCT01467466|Drug|IV isotonic bicarbonate|The investigators will administer 3 ml/kg of isotonic bicarbonate over 1 hour at an infusion rate of not less than 1 mL/kg per hour and not more than 3 mL/kg per hour prior to the angiographic procedure, 1-1.5ml/kg per hour during angiography, and 6 ml/kg of isotonic bicarbonate over 4 hours following the procedure at an infusion rate of not less than 1 mL/kg per hour and not more than 1.5 mL/kg per hour. Providers will retain discretion to administer larger volumes of isotonic bicarbonate (up to a maximum of 12 mL/kg) over durations of up to 12 hours pre and 12 hours post-procedure.
16190571|NCT01467466|Drug|N-acetylcysteine|NAC will be administered at a dose of 1200mg orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.
16190572|NCT01467466|Drug|Placebo|A placebo study drug capsule will be administered orally 1 hour prior to angiography, 1 hour following the procedure, and then twice daily for the next 4 days.
16190573|NCT01467453|Device|Triggerfish|The Triggerfish is a contact lens with an embedded sensor to track changes in intraocular pressure during a period of 24 hours.
16190574|NCT01467440|Device|Selective Laser Trabeculoplasty|trabeculoplasty with an SLT-Laser to reduce intraocular pressure
16190575|NCT01467427|Drug|nonacog beta pegol|A single dose of 40 U/kg will be administered intravenously, i.v. (into the vein) once weekly.
16190576|NCT01467414|Drug|insulin degludec|Injected s.c. (under the skin) once daily for 6 days
16190577|NCT01467401|Drug|biphasic insulin aspart|Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily
16190578|NCT01467401|Drug|biphasic human insulin|Individually adjusted dose. Injected subcutaneously (s.c., under the skin) twice daily
16190579|NCT01467388|Procedure|selective laser trabeculoplasty (SLT)|trabeculoplasty with an SLT-Laser to reduce intraocular pressure
16190580|NCT01467375|Drug|biphasic insulin aspart|Individually adjusted dose, injected s.c. (under the skin) before breakfast and dinner
16190581|NCT01467362|Drug|V0034CR01B|Cream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 91 days
16190582|NCT01467362|Drug|Vehicle cream|Cream Out of flares: 1 application bid (morning and evening) During flares: 1 application once a day (in the morning) Maximum 28 days
16190583|NCT01467362|Drug|desonide 0.1% cream|cream, once a day (in the evening) during flares
16190584|NCT01467362|Other|Foaming gel|for the washing and cleaning
16190585|NCT01467336|Procedure|Arthroscopic rotator cuff repair|Arthroscopic rotator cuff repair for all groups
16190586|NCT01467323|Drug|biphasic insulin aspart|Injected subcutaneously (under the skin) twice daily
16190587|NCT01467323|Drug|biphasic human insulin|Injected subcutaneously (under the skin) twice daily
16190588|NCT01467310|Drug|GSK1120212|1.5 to 2.0 mg taken orally every day for seven days.
16190589|NCT01467297|Drug|ceftidoren|ceftidoren 200 mg bid for 5 days
16190590|NCT01467297|Drug|levofloxacin|levofloxacin 500 mg once daily for 7 days
16190591|NCT01467284|Behavioral|Step Ahead|Promotion of weight gain prevention among teachers and staff in public high schools through Step Ahead, a comprehensive intervention targeting three levels suggested by the ecological framework health behavior change: organizational school level, interpersonal level, and individual level.
16190592|NCT01467284|Behavioral|Basic Intervention|Promotion of weight gain prevention among teachers and staff in public high schools through receipt of the workbook print materials and access to website similar to the enhanced intervention.
16190593|NCT01467258|Drug|Amantadine|Single dose
16190594|NCT01467245|Procedure|Hypercapnia during thoracoscopy|keyhole surgery through the chest for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates
16190595|NCT01467245|Procedure|Open surgery|open surgery for repair of oesophageal atresia with tracheo-oesophageal fistula or congenital diaphragmatic hernia in neonates
16190596|NCT01467232|Biological|Injection of autologous CD133+ stem cells at the time of coronary artery bypass grafting|Following completion of the distal coronary artery bypasses, autologous CD133+ stem cells, or placebo (saline solution containing autologous plasma without CD133+) will be injected into the myocardium.
16190597|NCT01467232|Biological|Injection of autologous CD133+ stem cells at the time of coronary artery bypass grafting|Following completion of the distal coronary artery bypasses, autologous CD133+ stem cells, or placebo (saline solution containing autologous plasma without CD133+) will be injected into the myocardium
16190598|NCT01467219|Procedure|lymphadenectomy|bilateral pelvic and para-aortic lymph node dissection
16190599|NCT01467219|Procedure|therapeutic conventional therapy|hysterectomy, bilateral salpingo-oophorectomy,bilateral pelvic and para-aortic lymph node dissection +/- omentectomy via laparotomy, laparoscopy or robotic-assisted
16190600|NCT01467219|Procedure|Positron Emission Tomography/ Computed Tomography|Pre-operative PET/CT scan
16190601|NCT01467219|Radiation|fludeoxyglucose F 18|5 MBq/kg body weight of FDG (up to 550 MBq)
16190652|NCT01466829|Drug|Placebo|Placebo; saline injection.
16193900|NCT01442506|Other|biopsies|taking biopsies
16190602|NCT01467206|Behavioral|Long term follow up by a coordinating physiotherapist|Monthly meetings with an coordinating physiotherapist who motivate and encourage the patient to do 60 minutes of weekly exercise and 30 minutes of daily physical activity
16190603|NCT01467206|Behavioral|Standard care|Standard care as it is given to all stoke patients after stroke
16190604|NCT01467193|Dietary Supplement|Fat diet|Instructions for a high fat diet will be given at the end of visit 2. This consists of the usual food intake with a supplementary fat intake of 0.75g fat/kg BW, administered as 3 additional snacks. These snacks will be distributed in pre-packed bags. A food diary will be kept. All arms will receive this diet during the 3 days preceding the clamp.
16190605|NCT01467193|Other|2h standardized aerobic exercise|Aerobic (50-60% of Vo2 max) standardized exercise on a bicycle during 2 hours
16190606|NCT01467180|Device|septeX|continuous veno-venose hemodialysis (CVVHD) with dialysate flow rate (Qd)of 35ml/kg/h for 48h
16190607|NCT01467180|Device|HF CVVH|continuous veno-venose hemofiltration (CVVH) with 35ml/kg/h UF-rate for 48h
16190608|NCT01467141|Drug|insulin aspart|Injected s.c. (under the skin) three times a day
16190609|NCT01467141|Drug|human insulin|Injected s.c. (under the skin) 30 minutes before the meals
16190610|NCT01467141|Drug|isophane human insulin|May be administered s.c. (under the skin) in both treatment groups thrice daily
16190611|NCT01467128|Other|Structured expert pharmacist review|The researcher will apply the pharmacist intervention to the cases randomised to this arm of the study. This consists of an expert pharmacist review of the patients prescribed medications at the time of recruitment into the study. Recommendations following the intervention will be communicated both verbally and in writing to the medical team with primary responsibility for the patient. Recommendations arising from the intervention will be printed out and inserted into the patients' notes, in addition to the relevant registrar being informed in person or via the telephone.
16190612|NCT01467128|Other|No Intervention|Normal hospital pharmaceutical care
16190613|NCT01467115|Radiation|Radiotherapy|3D conformal radiation therapy or Intensity-Modulated Radiation Therapy (IMRT) with or without Image Guided Radiation Therapy (IGRT) will be used for all patients. Radiotherapy will be delivered in 1.8 to 2.25 Gy fractions daily, five days per week excluding holidays, for a total of 66-72 Gy delivered to the Gross Tumor Volume (GTV, defined below) plus appropriate margin and 44-59.4 Gy to at-risk lymph nodes as determined by primary tumor characteristics. Alternative fractionation and dosing schema may be used as deemed appropriate for an individual case. For IMRT, the minimum Planning Target Volume (PTV) dose should be 90% of the prescription dose and a minimum of 95% of the PTV should receive the prescribed dose.
16190614|NCT01467115|Drug|Leucovorin|5FU is given after, or at the midpoint, of the leucovorin infusion. Leucovorin is usually administered by I.V. bolus injection or short (10-120 minutes) I.V. infusion but oral formulation may be substituted should supply warrant.
16190615|NCT01467115|Biological|Cetuximab|Cetuximab will be given for the duration of radiotherapy. A loading dose of intravenous cetuximab at 400mg per square meter body-surface area will be given over two hours up to seven days prior to initiation of radiation treatments or on the day of the first treatment (drug information detailed below). Thereafter, cetuximab will be given weekly over 60 minutes at a dose of 250 mg per meter squared. Intravenous diphenhydramine (50 mg) will be given as premedication.
16190616|NCT01467115|Drug|Filgrastim|Neupogen®: 300 mcg/mL (1 mL, 1.6 mL). May be administered undiluted by SubQ injection. May also be administered by I.V. bolus over 15-30 minutes in D5W, or by continuous SubQ or I.V. infusion. Do not administer earlier than 24 hours after or in the 24 hours prior to cytotoxic chemotherapy.
16190617|NCT01467115|Drug|Erythropoetin|Subcutaneous or intravenous
16190618|NCT01467115|Drug|Cisplatin|One cycle of induction chemotherapy will be comprised of docetaxel on day 1 and cisplatin and 5-fluorouracil given days 1, 8, and 15. Intravenous docetaxel will be administered over one hour at a dose of 75 mg per square meter of body-surface area, followed by intravenous cisplatin at 35 mg per square meter, administered during a period of 0.5 to 3 hours weekly. After completion of the cisplatin infusion, intravenous fluorouracil will be given as a bolus at 1000 mg per square meter, followed by leucovorin at the dose of 350mg/m2. There will be total 4 cycles of chemotherapy of which 2 cycles will be prior to radiation therapy and 2 cycles will be post-radiation.
16190619|NCT01467115|Drug|Fluorouracil|One cycle of induction chemotherapy will be comprised of docetaxel on day 1 and cisplatin and 5-fluorouracil given days 1, 8, and 15. Intravenous docetaxel will be administered over one hour at a dose of 75 mg per square meter of body-surface area, followed by intravenous cisplatin at 35 mg per square meter, administered during a period of 0.5 to 3 hours weekly. After completion of the cisplatin infusion, intravenous fluorouracil will be given as a bolus at 1000 mg per square meter, followed by leucovorin at the dose of 350mg/m2. There will be total 4 cycles of chemotherapy of which 2 cycles will be prior to radiation therapy and 2 cycles will be post-radiation.
16190620|NCT01467115|Drug|Docetaxel|One cycle of induction chemotherapy will be comprised of docetaxel on day 1 and cisplatin and 5-fluorouracil given days 1, 8, and 15. Intravenous docetaxel will be administered over one hour at a dose of 75 mg per square meter of body-surface area, followed by intravenous cisplatin at 35 mg per square meter, administered during a period of 0.5 to 3 hours weekly. After completion of the cisplatin infusion, intravenous fluorouracil will be given as a bolus at 1000 mg per square meter, followed by leucovorin at the dose of 350mg/m2. There will be total 4 cycles of chemotherapy of which 2 cycles will be prior to radiation therapy and 2 cycles will be post-radiation.
16190621|NCT01467089|Other|Two way video assessment|Participants will be assessed extrapyramidal symptoms and tardive dyskinesia
16190622|NCT01467076|Drug|Aerosolized Normal Saline|Two initial doses of IPGE1 will be tested - 150 and 300 ng/kg/min. Thus, there will be three arms to the study - IPGE1 [150], IPGE1 [300], and placebo (normal saline). This design will allow comparison of the two doses of IPGE1 with each other and controls; and also allow comparison of any IPGE1 with controls. Placebo will be administered over a maximum duration of 72 hours.
16190623|NCT01467076|Drug|Inhaled PGE1|Two initial doses of IPGE1 will be tested - 150 and 300 ng/kg/min. Thus, there will be three arms to the study - IPGE1 [150], IPGE1 [300], and placebo (normal saline). This design will allow comparison of the two doses of IPGE1 with each other and controls; and also allow comparison of any IPGE1 with controls. In this Pilot RCT, two doses of IPGE1 (300 and 150 ng/kg/min) will be administered over a maximum duration of 72 hours to determine the optimal dose and duration of therapy.
16190731|NCT01466283|Genetic|fluorescence in situ hybridization|
16190732|NCT01466283|Genetic|gene expression analysis|
16190624|NCT01467063|Dietary Supplement|Glutamine|Participants will keep a diary of food intake and activity as well as wear an accelerometer (to measure overall movement) for 2-3 days prior to the admission. Subject will come to the Clinical Research Center for approximately 24 hours. They will receive a drink containing Glutamine (0.25 g/kg/dose). Afterwards they will have an afternoon exercise session consisting of 15-min bouts of exercise, interspersed with 5-min rest periods in between for a total of 75min. Blood glucose will be checked during rest intervals. They will be served a controlled dinner. Before bedtime another dose of the same drink will be given. Overnight blood glucose will be monitored closely. In the morning, another dose of the same drink will be given. Subjects will have two isotope infusions (non-radioactive) running concomitantly and a hyperinsulinemic-euglycemic clamp will be performed. Afterwards lunch will be served and subject discharged home.
16190625|NCT01467063|Dietary Supplement|Placebo|Participants will keep a diary of food intake and activity as well as wear an accelerometer (to measure overall movement) for 2-3 days prior to the admission. Subject will come to the Clinical Research Center for approximately 24 hours. They will receive a PLACEBO drink. Afterwards they will have an afternoon exercise session consisting of 15-min bouts of exercise, interspersed with 5-min rest periods in between for a total of 75min. Blood glucose will be checked during rest intervals. They will be served a controlled dinner. Before bedtime another dose of the same drink will be given. Overnight blood glucose will be monitored closely. In the morning, another dose of the same drink will be given. Subjects will have two isotope infusions (non-radioactive) running concomitantly and a hyperinsulinemic-euglycemic clamp will be performed. Afterwards lunch will be served and subject discharged home.
16190626|NCT01467050|Other|Application of STOPP/START criteria|"The researcher will apply the STOPP/START criteria to the cases randomised to this intervention. This will occur at the point of recruitment into the study and consists of applying STOPP/START criteria to the list of prescribed medications the patient is taking at that time point.
~Where potentially inappropriate medications (PIM's) are identified using the intervention, these are highlighted to the medical team with primary responsibility for the patient both verbally and in writing. The relevant registrar will be contacted in person or via telephone by the researcher and informed of the PIM's in addition to a standard medication advice form inserted into the patients' notes also highlighting the PIM's."
16190627|NCT01467050|Other|Normal pharmaceutical care|The normal process of medication prescription and review by the attending medical team.
16190628|NCT01467037|Other|No intervention done|Not applicable because no intervention was done.
16190629|NCT01467024|Other|CDPHL Algorithm|Supplemental testing algorithm performed by the CDPHL.
16190630|NCT01467011|Drug|Enteric-coated Mycophenolate Sodium|1440mg/day for 6 months posttransplant
16190631|NCT01466998|Other|Paced Respiration|Practice paced respiration 15 minutes per day for a total of 12 weeks.
16190632|NCT01466998|Other|Music Therapy|Practice music therapy for 15 minutes per day for a total of 12 weeks.
16190633|NCT01466985|Drug|Doravirine|Doravirine tablets, orally, once daily for 7 days at a dose of 25 mg in Panel A and 200 mg in Panel B; dose in Panel C to be determined (≤200 mg).
16190634|NCT01466985|Drug|Placebo|Placebo tablets once daily for 7 days.
16190635|NCT01466972|Drug|Pazopanib|Oral, 800mg tablet daily per cycle
16190636|NCT01466959|Other|citrate dialysate (CD)|Citrasate (CD) is substituted as the dialysate during the patients regular dialysis run 4hours three times weekly for a period of 2 weeks. The only difference between citrasate and the regular dialysate is the lack of acetic acid.
16190637|NCT01466959|Other|acetic-acid based dialysate (AD)|Acetate based dialysate; AD is the standard dialysate used in hemodialysis runs 4 hours three times weekly. For the study it will be used for a period of 2 weeks and compared to the CD study time period.
16190638|NCT01466946|Behavioral|semi-structured interviews|Use semi-structured interview methods to gather narrative data from research participants, as more open-ended interviews allow participants to share information that is most relevant to their own experiences (Patton, 2002; Rubin & Rubin, 2005; Kvale, 1996). Semi-structured interviewing can generate a rich understanding of a participant's life routines, experiences, and attitudes related to a topic of inquiry, and can yield a nuanced and thorough description of a research participant's life story and belief systems.
16190639|NCT01466933|Behavioral|Responsive parenting|On a monthly basis, mothers meet with the peer educator to learn about ways to provide a hygienic environment (hand-washing), proper diverse diet (family foods, breast milk), play materials and conversation to stimulation their child's cognitive and language development. Mothers practice with their child and are coached by the peer educator.
16190640|NCT01466933|Behavioral|Child Development|On a monthly basis, mothers meet with the government worker to learn about ways to provide a hygienic environment (hand-washing), proper diverse diet (family foods, breast milk), play materials and conversation to stimulation their child's cognitive and language development.
16190641|NCT01466907|Other|Secondary prevention, supportive counselling|Patients' self-reports on Mobility, Self Care, Usual activities, Pain/Discomfort, Anxiety/Depression, Health Outcome were registered. Health problems were assessed. Secondary prevention was controlled by measuring blood pressure, Cholesterol levels, HbA1c, Weight to estimate nutritional status. Functional status was assessed. Supportive counselling was provided. Referral was sent to physician if medical interventions were needed.
16190642|NCT01466907|Other|Standard care until one year follow-up|No intervention three months after stroke. Assessment one year after stroke and comparison with the intervention group.
16190643|NCT01466894|Biological|IMM 124-E|Tablets orally twice a day for 24 weeks
16190644|NCT01466894|Biological|Placebo|Tablets orally twice daily for 24 weeks
16190645|NCT01466881|Drug|Alisertib|Given PO
16190646|NCT01466881|Other|Laboratory Biomarker Analysis|Correlative studies
16190647|NCT01466881|Other|Pharmacological Study|Correlative studies
16190648|NCT01466868|Drug|MK2206|"Treatment will be administered orally once weekly, 2 hours before or after a meal, at day 1, 8, 15, 22 over a 28 day cycle period.
~The starting dose level is 200 mg. 2 dose reduction are allowed (135 mg and 90 mg)in case of documented toxicity according to the specific algorithms."
16190649|NCT01466855|Drug|Intra-Ophthalmic Artery Topotecan Infusion|Topotecan via intra-ophthalmic artery delivery infused over 30 minutes on Day 1 of every 21-day cycle.
16190650|NCT01466842|Procedure|Catheter ablation using cryothermia|Three months before the catheter ablation procedure, a subcutaneous loop recorder will be implanted. The ablation procedure will be performed using cryothermia.
16193901|NCT01442506|Other|biopsy|biopsy
16190653|NCT01466816|Dietary Supplement|test meals with various fatty acid compositions|Three different milkshakes with a U13C palmitate tracer added
16190654|NCT01466803|Drug|Placebo|The subjects will be given placebo twice a day for 5 days prior to the study
16190655|NCT01466803|Drug|Vorikonazole|The subject will be given vorikonazole twice a day for 5 days prior to the study. The dose will be 400 mg twice a day on day one ans 200 mg twice a day on days 2-5.
16190656|NCT01466790|Drug|TMC435|TMC435 will be administered as one oral capsule of 150 mg once a day.
16190657|NCT01466790|Drug|PSI-7977 (GS7977)|PSI-7977 (GS7977) will be administered as oral tablets (2 tablets of 200 mg for Cohort 1 and 1 tablet of 400 mg for Cohort 2) once a day.
16190658|NCT01466790|Drug|Ribavirin|Ribavirin will be administered according to body weight. For patients with body weight less than 75 kg daily dose (1000 mg) will be administered as 400 mg (2 oral tablets of 200 mg) in the morning and 600 mg (3 oral tablets of 200 mg) in the evening. Body weight more than or equal to 75 kg daily dose (1200 mg) will be administered as 600 mg twice a day (3 tablets of 200 mg per intake, morning and evening).
16190659|NCT01466777|Procedure|Traditional surgery type|Traditional laparoscopic surgery for endometrial cancer
16190660|NCT01466777|Procedure|Robotic assisted laparoscopic surgery|Robotic assisted laparoscopic surgery for endometrial cancer
16190661|NCT01466764|Drug|Anakinra|An injection of 100 mg Anakinra was administered 1 hour prior to surgery and again 24 hours following surgery.
16190662|NCT01466764|Other|Normal Saline|An injection of normal saline was administered 1 hour prior to surgery and again 24 hours following surgery.
16190663|NCT01466751|Behavioral|Computerized Neurobehavioral Intervention|Targeted, computerized interventions completed from the participants' own home on a computer.
16190664|NCT01466738|Biological|HRV-16 (100 TCID50)|Each volunteer will receive a single administration of 100 TCID50 of HRV-16 in a total volume of approximately 1.0 mL administered via 4 intranasal instillations.
16190665|NCT01466738|Biological|HRV-16 (1000 TCID50)|Each volunteer will receive a single administration of 1000 TCID50 of HRV-16 in a total volume of approximately 1.0 mL administered via 4 intranasal instillations.
16190666|NCT01466725|Drug|CC-930|
16190667|NCT01466725|Drug|Placebo|Placebo
16190668|NCT01466712|Drug|Tiotropium + formoterol/beclometasone|Tiotropium 18 µg/dose once daily (handihaler device) + formoterol, fumarate 6µg + beclometasone, dipropionate 100µg / dose (Pressurised inhaler): 2 puffs bid, for one month.
16190669|NCT01466712|Drug|tiotropium + placebo|Tiotropium 18 µg/dose once daily (handihaler device) + placebo (Pressurised inhaler): 2 puffs bid, for one month.
16190670|NCT01466686|Radiation|Low Dose Fractionated Radiation Therapy (LDFRT)|All patients will receive 0.5 Gy of radiation therapy twice daily. This study will include a safety run-in component. If > 33% of patients in the initial cohort of 6 experience grade 3 or greater hematologic toxicity according to the NCI Common Toxicity Criteria version 4, then a dose reduction will occur following the schedule listed below. Otherwise, following a 1 month waiting period after the first cycle of adjuvant LDFRT plus temozolomide for the first cohort of patients, the phase 2 study will open for full accrual. Patients will receive radiation with the first six 28-day cycles of temozolomide.
16190671|NCT01466686|Drug|Temozolomide|All patients will receive temozolomide (150 to 200 mg per square meter for 5 days during each 28 day cycle) for a total of 1 year or until the time of disease progression.
16190672|NCT01466673|Drug|Ethinyl estradiol/Norgestimate (EE/NGM)|Ethinyl estradiol/Norgestimate encapsulated oral tablet will be administered once daily at bed time as 0.035/0.18 milligram (mg) for Days 1-7, 0.035/0.215 mg for Days 8-14, and 0.035/0.250 mg for Days 15-21 of EE/NGM, respectively up to 6 consecutive menstrual cycles consisting of 21 days each.
16190673|NCT01466673|Drug|Ethinyl estradiol/Desogestrel (EE/DSG)|Ethinyl estradiol/Desogestrel oral formulation will be administered once daily at bed time as 0.040/0.025 mg for Days 1-7, 0.030/0.125 mg for Days 8-22 of EE/DSG, respectively up to 6 consecutive menstrual cycles consisting of 22 days each.
16190674|NCT01466660|Drug|Afatinib|afatinib once daily
16190675|NCT01466660|Drug|gefitinib|Gefitinib once daily
16190676|NCT01466647|Drug|AXL1717|A repeated BID treatment for 14 days, followed by a 7 day observation period for two treatment periods
16190677|NCT01466634|Procedure|percutaneous coronary intervention with stent|patients with coronary artery disease treated by percutaneous coronary intervention with BP-DES are compared with patients with coronary artery disease treated by percutaneous coronary intervention with PP-DES
16190678|NCT01466608|Drug|Rosuvastatin|Oral administration of rosuvastatin 20 mg once daily for 21 days.
16190679|NCT01466595|Drug|Rifaximin|Participant were administered one 550 mg tablet of rifaximin to be taken orally two times a day for 4 weeks.
16190680|NCT01466569|Drug|AbGn-7|Phase 1a: dose escalation; Drug: AbGn-7 weekly iv infusion Duration: 6 weeks
16190681|NCT01466569|Drug|AbGn-7|Phase 1b: two doses (one dose below MTD/MAD and MTD/MAD as determined in phase 1a) Drug: AbGn-7 weekly iv infusion combined with FOLFOX7 Duration: 6 weeks
16190682|NCT01466556|Other|Routine laboratory tests|Laboratory tests to determine metabolic syndrome
16190683|NCT01466543|Drug|Zydena (Udenafil)|Zydena (Udenafil) 100 mg, one time
16190684|NCT01466543|Drug|Placebo|Placebo
16190685|NCT01466530|Drug|Placebo|received sublingual two moistened white coated placebo tablets which looked identical in size, colour, and packing to misoprostol tablet.
16190686|NCT01466530|Drug|Misoprostol|sublingual misoprostol was given by putting two moistened tablets of misoprostol (400 µg) under the tongue and allowing them to dissolve (Misotac®, Sigma Pharmaceutical Industries, Egypt) (200 µg/tablet).
16190687|NCT01466517|Drug|Alivium®|400mg of Ibuprofen equivalent to 8mL (50mg/mL) oral suspension of the Reference Drug
16190688|NCT01466517|Drug|Ibuprofen|400mg of Ibuprofen equivalent to 10mL (40mg/mL) oral suspension of the Test Drug
16190689|NCT01466504|Procedure|skin punch biopsy|Skin biopsy prior to sorafenib or regorafenib treatment and when rash appears or 12 weeks into treatment.
16190733|NCT01466283|Genetic|reverse transcriptase-polymerase chain reaction|
16190734|NCT01466283|Other|laboratory biomarker analysis|
16190737|NCT01466257|Biological|cetuximab|
16190738|NCT01466257|Drug|cisplatin|
16190739|NCT01466257|Genetic|DNA analysis|
16190740|NCT01466257|Genetic|gene expression analysis|
16190690|NCT01466491|Drug|Paracervical block technique with lidocaine|The PCB will consist of a total of 20 mL local anesthetic (18 mL of 1% lidocaine buffered with 2 mL sodium bicarbonate) injected with the following technique: 2 mL are injected at the tenaculum site, 12 o'clock, superficially into the cervix. The tenaculum is placed at 12 o'clock. The remaining 18 mL are injected paracervically (vaginal fornices) over sixty seconds. The injection, occurring in either two or four sites, is continuous from superficial to deep (3 cm) to superficial (injecting with insertion and withdrawal). It will be followed with either no wait or a three-minute wait period.
16190691|NCT01466478|Drug|Ointment A: LEO 29102 2.5 mg/g plus calcipotriol 50 µg/g ointment|once daily application, 4 weeks
16190692|NCT01466478|Drug|Ointment B: LEO 29102 2.5 mg/g ointment|once daily application, 4 weeks
16190693|NCT01466478|Drug|Ointment C: Calcipotriol 50 µg/g ointment|once daily application, 4 weeks
16190694|NCT01466478|Drug|Ointment D: LEO 29102 2.5 mg/g plus calcipotriol 50 µg/g ointment|once daily application, 4 weeks
16190695|NCT01466478|Drug|Ointment G: LEO 29102 2.5 mg/g plus calcipotriol 50 µg/g ointment|once daily application, 4 weeks
16190696|NCT01466478|Drug|Daivonex® ointment|once daily application, 4 weeks
16190697|NCT01466478|Drug|Diprosone® ointment|once daily application, 4 weeks
16190698|NCT01466465|Drug|Cholecalciferol|given orally, once daily, before grass pollen season
16190699|NCT01466465|Other|middle-chain fatty acids (carrier)|given orally, once daily, before grass pollen season
16190700|NCT01466452|Drug|Aspirin|single-dose aspirin in 100 mg 1 tablet every 24 hours
16190701|NCT01466452|Drug|Aspirin|single-dose aspirin 200 mg 1 tablet every 24 hours
16190702|NCT01466452|Drug|Aspirin|double-dose aspirin 100 mg 1 tablet every 12 hours
16190703|NCT01466439|Procedure|high-frequency of repetitive transcranial magnetic stimulation (rTMS)|frequency of stimulation of 20 Hz
16190704|NCT01466439|Procedure|low frequency of repetitive transcranial magnetic stimulation (rTMS)|frequency of stimulation of 1 Hz
16190705|NCT01466413|Device|Tropoelastin|"Multiple intradermal implants comprising of three treatments, 3 weeks apart, each consisting of 16 injections in total, each 10mm apart in a grid formation over a 3cm x 3cm area of the mid to deep dermis of the medial aspect of the upper arm. Each injection will consist of 20-30ul of product delivered using a 30Gx¼ needle. Each subject will also receive Restylane® Vital Light (control) to the opposite arm following the same treatment regimen and using the same technique. The treatment will be administered on Day 1, 22 and 43."
16190706|NCT01466387|Biological|Typhoid Vi Polysaccharide Vaccine|One dose of typhoid Vi polysaccharide vaccine.
16190707|NCT01466387|Biological|Yellow Fever Vaccine|One dose of yellow fever vaccine.
16190708|NCT01466387|Biological|Japanese Encephalitis Vaccine|Two doses of Japanese Encephalitis Vaccine.
16190709|NCT01466387|Biological|Rabies Vaccine|Three doses of Rabies vaccine.
16190710|NCT01466387|Biological|MenACWY-CRM Vaccine|One dose of MenACWY-CRM vaccine.
16190711|NCT01466374|Drug|Placebo|Normal Saline, Intravenous (IV), 0 mg, Once a week for the first week and every other week thereafter, 11 weeks
16190712|NCT01466374|Drug|Placebo|Normal Saline, Intravenous, 0 mg, Every other week, Up to 337days
16190713|NCT01466374|Drug|BMS-936557 (Anti-IP-10 Antibody)|Solution for IV administration, Intravenous, 10 mg/kg, Once a week for the first week and every other week thereafter, 11 weeks
16190714|NCT01466374|Drug|BMS-936557 (Anti-IP-10 Antibody)|Solution for IV administration, Intravenous, 20 mg/kg, Once a week for the first week and every other week thereafter, 11 weeks
16190715|NCT01466374|Drug|BMS-936557 (Anti-IP-10 Antibody)|Solution for IV administration, Intravenous, 7.5 mg/kg, Every other week, Up to 337 days
16190716|NCT01466374|Drug|BMS-936557 (Anti-IP-10 Antibody)|Solution for IV administration, Intravenous, 15 mg/kg, Every other week, Up to 337 days
16190717|NCT01466374|Drug|BMS-936557 (Anti-IP-10 Antibody)|Solution for IV administration, Intravenous, 15 mg/kg or optimal dose, Every other week, Open
16190718|NCT01466361|Drug|Nicotine lower dose|lower dose nicotine lozenge
16190719|NCT01466361|Drug|Nicotine higher dose|higher dose nicotine lozenge
16190720|NCT01466361|Drug|Placebo|placebo
16190721|NCT01466348|Drug|Paracetamol and Caffeine|Paracetamol 1000 mg and caffeine 130 mg
16190722|NCT01466348|Drug|Paracetamol|Paracetamol 1000 mg
16190723|NCT01466335|Drug|Ronacaleret (100mg tablet)|100mg tablet
16190724|NCT01466335|Drug|Placebo|matching placebo tablet
16190725|NCT01466322|Drug|GSK2018682 CD2 Capsule; GSK2018682 CD3 non-micronised Tablet; GSK2018682 CD3 micronised Tablet; GSK2018682 CD3 non-micronised Tablet in fed state|Four single dosing sessions where each regimen A,B C or D will be administered orally in a randomised, cross-over manner. At each dosing session, pharmacokinetic sampling time-points will be the same.
16190726|NCT01466309|Device|Somnoguard oral appliances|wearing somnogaurd daily at bedtime
16190727|NCT01466296|Device|Chaotic Perturbation|"Each subject will undergo 36 intervention sessions, 3 times per week over 12 weeks. Each session will last up to 45 minuets, depending on the subject's endurance. During each session the subject will perform basic stretching and muscle strengthening, then wear the random shoes and perform a set of exercises following specific verbal tasks, e.g., Walk 5 strides forward, or, Walk to the right side until I ask you to stop. During this stage of walking the device will impose perturbations in the range tolerated by the subject. The therapist will make a written report of each session."
16190728|NCT01466296|Device|Dummy not active shoes|"Each subject will undergo 36 intervention sessions, 3 times per week over 12 weeks. Each session will last up to 45 minuets, depending on the subject's endurance. During each session the subject will perform basic stretching and muscle strengthening, then wear the dummy shoes and perform a set of exercises following specific verbal tasks, e.g., Walk 5 strides forward, or, Walk to the right side until I ask you to stop. During this stage of walking the device will not impose perturbations. The therapist will make a written report of each session."
16190729|NCT01466296|Device|Treadmill training|Each subject will undergo 36 intervention sessions, 3 times per week over 12 weeks. Each session will last up to 45 minuets, depending on the subject's endurance. During each session the subject will exercise basic stretching and muscle strengthening, then walk on the treadmill. A physiotherapist according the subject's rate of improvement will determine the increase in treadmill velocity and slope. The therapist will make a written report after each session.
16190730|NCT01466283|Genetic|DNA methylation analysis|
16190749|NCT01466231|Drug|Everolimus|Tablets p.o. 10 mg daily until progression, unacceptable toxicity, complete response or inability of the subject to comply with study requirements.
16190750|NCT01466205|Drug|DAR-0100A|DAR-0100A will be administered intravenously in a dose of 15mg in 150mls of saline over 30 minutes at approximately 11:00AM on each of three consecutive days of administration. Additional saline will be co-administered to ensure hydration.
16190751|NCT01466205|Drug|Placebo|150mls of saline is administered over 30 minutes at approximately 11:00AM on each of three consecutive days of administration. Additional saline will be co-administered to ensure hydration.
16190752|NCT01466192|Drug|MP-424 (generic name:Telaprevir)|750mg q8h for 12 weeks
16190753|NCT01466192|Drug|Ribavirin|400 - 1000 mg/day based on body weight for 24 weeks
16190754|NCT01466192|Drug|Peginterferon alfa-2b|1.5mcg/kg/week for 24 weeks
16190755|NCT01466179|Biological|Blinatumomab|Continuous intravenous infusion over four weeks per treatment cycle
16190756|NCT01466166|Biological|Pegloticase|Pegloticase 8 mg intravenous every 2 weeks
16190757|NCT01466153|Drug|Rituximab|Rituximab was administered by IV infusion as a dose of 375 mg/m^2 on Day 2 of Cycle 1 and then at 500 mg/m^2 on Day 1 of up to 5 subsequent 28-day cycles
16190758|NCT01466153|Drug|Bendamustine|Bendamustine was administered by IV infusion as a dose of 70 mg/m^2 on Day 1 and Day 2 of each 5 subsequent 28-day cycle.
16190759|NCT01466153|Drug|MEDI-551|MEDI-551 was administered at 2 mg/kg or 4 mg/kg by IV infusion on Days 2 and 8 of Cycle 1 and then on Day 1 of up to 5 subsequent 28-day cycles.
16190760|NCT01466140|Other|Writing down request for help|Patients in the intervention group could write down their request for help on a request card (with a maximum of 2 questions).
16190761|NCT01466127|Drug|Oxytocin|Liquid metered-dose nasal spray, 30 IUs, administered once.
16190762|NCT01466127|Drug|Placebo|Matched nasal spray placebo
16190763|NCT01466114|Drug|estriol|4 capsules of 2 mg (total of 8 mg) PO QD
16190764|NCT01466114|Other|Placebo|4 capsules PO QD
16190765|NCT01466114|Drug|Norethindrone|Starting at month 6, and at Months 9 and 12: subjects who are on estriol (Group A) take 0.7 mg PO QD for 2 weeks.
16190766|NCT01466114|Other|Progestin Placebo|Starting at Month 6 and at Months 9 and 12: subjects who are on placebo (Group B) take a second progestin placebo pill PO QD for 2 weeks.
16190767|NCT01466101|Drug|Placebo administration|Administration of placebo
16190768|NCT01466101|Drug|Pregabalin administration|Administration of pregabalin
16190769|NCT01466088|Drug|Donepezil|Subjects taking donepezil will take 1-2 capsules of 5 mg donepezil and a placebo for AZD3480 (to maintain blind) orally once a day.
16190770|NCT01466088|Drug|AZD3480|Subjects taking 30 mg AZD3480 will take one capsule of AZD3480 and two capsules of placebo for donepezil (to maintain blind) orally once a day.
16190771|NCT01466075|Device|Apollo Evolution Investigational BG Monitoring System|Untrained subjects with diabetes perform self Blood Glucose (BG) tests with capillary fingerstick blood and Alternative Site Testing (AST) of the palm using the Apollo Evolution meter and an investigational sensor. Study staff test subject venous blood and all BG results are compared to a reference laboratory glucose method. Untrained subjects complete basic tasks using the User Guide and provide feedback.
16190772|NCT01466062|Drug|Palivizumab|
16190773|NCT01466036|Drug|Cabozantinib|60 mg QD orally in cycles of 28 days
16190774|NCT01466010|Procedure|surgical removal of osteoid osteoma|surgery for osteoid osteoma: this may include curettage or en-bloc resection of the lesion
16190775|NCT01465997|Drug|Lacosamide|50 and 100 mg tablets of Lacosamide given as 100 mg/day, 200 mg/day, 300 mg/day, 400 mg/day, 500 mg/day or 600 mg/day throughout the Treatment Period (Maximum 3.5 Years)
16190776|NCT01465997|Drug|Carbamazepine-Controlled Release (CBZ-CR)|200 mg tablets of Carbamazepine-CR given as 200 mg/day, 400 mg/day, 600 mg/day, 800 mg/day, 1000 mg/day or 1200 mg/day throughout the Treatment Period (Maximum 3.5 Years)
16190777|NCT01465984|Drug|Paracetamol|paracetamol , 1 gram Iv infusion Morphine Sulfate0.1 Mg/Kg Iv
16190778|NCT01465958|Biological|GAMUNEX-C|GAMUNEX-C Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Intravenous Administration: 200-600 mg/kg per intravenous infusion every 3-4 weeks
16190779|NCT01465958|Biological|GAMUNEX-C|GAMUNEX-C Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified, Subcutaneous Administration: weekly subcutaneous infusion at a mg/kg dose based on subject's intravenous dose and dosing interval x 1.37 conversion factor
16190780|NCT01465945|Procedure|Defect Unsutured|The defect is not sutured after the rectal tumor is removed by TEM.
16190781|NCT01465945|Procedure|Defect Sutured|Defect is sutured after the rectal tumor has been removed by TEM.
16190782|NCT01465932|Other|Control, no Proprioception|The period of data collection period was from June 2010 to August 2011. All subjects who met the inclusion criteria, were randomly allocated to group 1 (control) or group 2 (experimental). Both groups consisted of 12 physical therapy sessions, taking place 2 times a week for 6 weeks. After randomization, subjects were allocated to group 1 (control group) underwent cervical stretching exercises, strengthening the scapular muscles and rotator cuff and cryotherapy.
16190783|NCT01465932|Other|Experimental, Proprioceptive exercises|The period of data collection period was from June 2010 to August 2011. All subjects who met the inclusion criteria, were randomly allocated to group 1 (control) or group 2 (experimental). Both groups consisted of 12 physical therapy sessions, taking place 2 times a week for 6 weeks. After randomization, subjects were allocated to group 2 (experimental group) underwent cervical stretching exercises, strengthening the scapular muscles and rotator cuff exercises and cryotherapy as well as proprioceptive sensory-motor
16190784|NCT01465919|Drug|Mirtazapine|Mirtazapine will be administered at baseline, 1-week, 2-week, 4-week, 6-week, and 8-week, dosing between 7.5mg/day and 45mg/day, in patients with interferon induced depression.
16190785|NCT01465919|Other|Supportive psychotherapy|Supportive psychotherapy will be administered at baseline, 1-week, 2-week, 4-week, 6-week, and 8-week in patients with interferon induced depression.
16190786|NCT01465906|Drug|tulobuterol|patch, 2mg, qN, 3 months
16190787|NCT01465906|Drug|Tiotropium Bromide|18ug, inhale, qD, 3 months
16190788|NCT01465906|Drug|tiotropium bromide|18ug, inhale, qD, 3 months
16190789|NCT01465893|Drug|Vitamin D|vitamin D ,50000 unit /week
16190790|NCT01465893|Drug|Vitamin D withheld|do not receive anything
16190792|NCT01465867|Dietary Supplement|Selenium|83 micrograms of selenium (in the form of selenium methionine) in tablet form taken orally daily for all the length of pregnancy and for 3-6th month after labour
16190793|NCT01465867|Other|Sugar Pill Placebo|Placebo supplements in the same capsule as selenium. 1 tablet daily for all the length of pregnancy and for 3-6th month after labour.
16190794|NCT01465867|Other|Selenium + L-Thyroxine (LT4)|"83 micrograms of selenium (in the form of selenium methionine) in tablet form taken orally daily for all the length of pregnancy and for 3-6th month after labour
~+ LT4 taken orally daily according to the dose required(in women already receiving it or needing of start it)"
16190795|NCT01465867|Other|Sugar Pill Placebo + L-Thyroxine (LT4)|"Placebo supplements in the same capsule as selenium. 1 tablet daily for all the length of pregnancy and for 3-6th month after labour
~+ LT4 taken orally daily according to the dose required(in women already receiving it or needing of start it)"
16190796|NCT01465841|Device|PC 400 coils (Penumbra )|The Penumbra Embolization Coil is indicated for the endovascular embolization of aneurysms. The Embolization Coil functions to selectively embolize aneurysms by packing a sufficient quantity of soft platinum coils to achieve occlusion. The Coil Implant is constructed of 92% Platinum and 8% Tungsten round wire with a diameter approximately 0.0015in ± 0.0001in. The maximum primary diameter is 0.022in and the coil implant will have a semi-spherical atraumatic distal tip.
16190797|NCT01465828|Drug|Clopidogrel|Patient will be randomized to this intervention will receive in the first time the high clopidogrel dose and after 14 days we will change their therapy with standard dose of prasugrel (crossover).
16190798|NCT01465828|Drug|prasugrel|Patient will be randomized to this intervention will receive in the first time the standard dose of prasugrel and after 14 days we will change their therapy with high dose of clopidogrel (crossover).
16190799|NCT01465815|Drug|erlotinib hydrochloride|Given PO
16190800|NCT01465815|Drug|linsitinib|Given PO
16190801|NCT01465815|Drug|placebo|Given PO
16190802|NCT01465815|Radiation|radiation therapy|Undergo radiation therapy
16190803|NCT01465815|Procedure|therapeutic conventional surgery|Undergo planned surgery
16190804|NCT01465815|Other|laboratory biomarker analysis|Correlative studies
16190805|NCT01465802|Drug|Dacomitinib|Dacomitinib 45 mg orally daily on a continuous schedule until disease progression, toxicity, death or withdrawal of consent
16190806|NCT01465802|Drug|Dacomitinib|Dacomitinib 45 mg orally daily on a continuous schedule for the first 10 days in Cycle 1, followed by 4 days off treatment, followed by continuous daily dosing until disease progression, toxicity, death or withdrawal of consent
16190807|NCT01465802|Drug|Doxycycline|Doxycycline or Doxycycline placebo BID for 4 weeks
16190808|NCT01465802|Drug|Probiotic|VSL#3 probiotic 4 capsules orally daily or 1 sachet orally daily for up to 5 weeks (starting between Day minus 7 to Day minus 4 and continuing through Day 28)
16190809|NCT01465802|Drug|Alclometasone cream|Topical alclometasone diproprionate cream 0.05% applied to face, hands, feet, neck, back and chest at bedtime for 4 weeks
16190810|NCT01465776|Other|laboratory biomarker analysis|Correlative studies
16190811|NCT01465776|Other|preventative dietary intervention|lyophilized black raspberries(LBR) administration: 3 LBR troche lozenges (dissolved in mouth), 4 times/day beginning at minimum of 24 hrs following biopsy until night before surgery
16190812|NCT01465763|Drug|tofacitinib|10 mg oral BID
16190813|NCT01465763|Drug|Placebo|Plabebo oral BID
16190814|NCT01465737|Other|Histologic types|evaluate survival among different histologic types
16190815|NCT01465724|Procedure|Renal denervation|percutaneous selective renal sympathetic denervation with the use of the Symplicity Catheter system.
16190816|NCT01465711|Procedure|All abdominal surgical procedures|Laparotomy, Laparoscopy
16190817|NCT01465711|Procedure|Intubation|Ventilatory support
16190818|NCT01465711|Radiation|Imaging|Abdominal ultrasound Computer Tomography Magnetic Resonance Imaging
16190819|NCT01465698|Behavioral|Exercise|"The main target for exercise intervention is to restore impairments in movement control. First, the participants need to learn the proper technique of each exercise, second to achieve movement control of lumbar neutral zone in each exercise, and finally to increase the challenge of exercises for balance, coordination, muscular endurance and strength. Target dose for exercise is twice a week, 60 minutes per session for six months.
~The neuromuscular exercise program is progressive including three different performance levels. During the first eight weeks, the supervised exercise sessions will take place twice a week. The next 16 weeks the participants have one instructed weekly session, and they exercise once a week at home with help of a DVD or booklet produced for the study"
16190820|NCT01465698|Behavioral|Counseling|Counseling is conducted according cognitive-behavioral principles. Fear-avoidance model is implemented using problem based learning. The objective is to change participants' understanding of LBP towards less fearful and negative beliefs, and to provide encouragement for usual daily activities, including physical activity. Advice on nursing tasks that are strenuous for low back is aimed to improve awareness of injury risk and provide examples of proper postures and movements. The target is that participants in counseling groups attend 10 sessions each lasting 45 minutes. During the first four weeks the groups meet every second week, and after that once a month up to six months. Participants will receive workbooks to enhance problem-based learning.
16190821|NCT01465698|Behavioral|Exercise and counseling|Participants take part in both exercise and counseling as described in the separate interventions.
16190822|NCT01465698|Other|Control group|Participants in the control group take part only in measurements of NURSE-RCT.
16190823|NCT01465685|Drug|3,4-Methylenedioxymethamphetamine|125 mg per os, single dose
16190824|NCT01465685|Drug|Methylphenidate|1 hour before MDMA/placebo 60 mg methylphenidate per os, single dose
16190825|NCT01465685|Drug|Placebo|capsules identical to MDMA or methylphenidate
16190826|NCT01465659|Drug|temozolomide|Given PO
16190827|NCT01465659|Drug|pazopanib hydrochloride|Given PO
16190828|NCT01465646|Drug|levothyroxine|
16190829|NCT01465646|Drug|levothyroxine|
16190830|NCT01465633|Drug|levothyroxine|
16190831|NCT01465633|Drug|levothyroxine|
16190832|NCT01465620|Behavioral|hygienic-dietetic measures|Therapeutic education about hygienic-dietetic measures followed by a 5 minutes phone call per week during 3 months
16190984|NCT01464528|Drug|Hyaluronan|single use of 10 mL of the hyalobarrier gel intrauterine immediately following hysteroscopic surgery
16190833|NCT01465620|Behavioral|hygienic-dietetic measures|Therapeutic education about hygienic-dietetic measures followed by only one phone call
16190834|NCT01465607|Behavioral|Mujer Segura|Brief (35-minute) counseling intervention using techniques from Motivational Interviewing and principles of social cognitive theory (SCT) and theory of reasoned action (TRA).
16190835|NCT01465607|Behavioral|CENSIDA counseling program|Didactic HIV and STI counseling involving some personal risk assessment and presenting appropriate information on methods of transmission and for avoiding or reducing the risk of infection. Based on a counseling manual disseminated by CENSIDA, Mexico's federal HIV-AIDS prevention agency.
16190836|NCT01465594|Procedure|transurethral catheter after EERPE/ RALP|transurethral catheter after EERPE/ RALP
16190837|NCT01465594|Procedure|suprapubic catheter after EERPE /RALP|suprapubic catheter after EERPE /RALP
16190838|NCT01465581|Procedure|Division of the filum terminal|Division of the filum is performed through a 6cm incision over the lumbosacral junction that can be oriented either longitudinally or transversely - to be hidden beneath underclothes or swim wear. A single level laminectomy provides sufficient exposure. The dural opening can be as short as 1cm. Under the microscope the filum is identified visually and separated from lower sacral rootlets with the aid of microelectrode stimulation. When a segment of the filum has been excised and sent for laboratory examination, the dura is closed and reinforced with fibrin glue. The wound is closed in layers, and the patient is kept at bed rest horizontal for 2 nights to discourage CSF fistulization of the wound.
16190839|NCT01465568|Drug|Denosumab|60mg subcutaneous injection 6 monthly for 2 doses
16190840|NCT01465568|Drug|bisphosphonates|continue present bisphosphonate treatment
16190841|NCT01465555|Behavioral|Cognitive Behavioral Intervention|Counselors in this condition will work with the modified RecoveryTrack tested in the pilot study which has been altered to provide automated Clinical Alerts at either the intake, Month 1, or Month 2 CRM interview for High Risk patients. In addition, High Risk patients will be flagged in the counselor's caseload for discussion with clinical supervisors. Counselors in this condition will receive the Clinical Alert + Cognitive Behavioral Intervention (CBI) training, as well as monthly feedback from the Principal Investigator on their delivery of the CBI Months 1-3, with a booster session at Month 6.
16190842|NCT01465529|Drug|OligoG CF-5/20|6% OligoG CF-5/20 in water
16190843|NCT01465529|Drug|Saline|0.9% NaCl in water
16190844|NCT01465516|Drug|Boceprevir|"Baseline assessments must be obtained on the day of or prior to enrollment and prior to administration of the first dose of any study drug (BOC, PEG-IFN alfa-2b, or ribavirin).
~Using the RGT guidelines in patients who are previously untreated: all patients will receive a lead-in treatment of PR for 4 weeks, then BOC will be added to PR for 4 weeks; based on patient's week 8 HCV RNA results"
16190845|NCT01465503|Drug|Bivalirudin|Patients randomized to Bivalirudin group will be treated by bivalirudin before and during the procedure. Bivalirudin will be given as bolus of 0.75 mg/kg prior to the start of the intervention, followed by infusion of 1.75 mg/kg per hour for the duration of the procedure.The infusion will be lowered to 1.0 mg/kg per hour in patients with eGFR <30 ml/min/1.73 m2.
16190846|NCT01465503|Drug|Unfractionated Heparin|Patients randomized to the Control group will receive unfractionated heparn (UFH) before and during the procedure. UFH bolus will be of 70 UI/kg. If the activated clotting time measured 5 minutes after the study drug administration is lower than 270 seconds, an additional bolus of the randomised drug (UFH 20 U/kg) will be given.
16190847|NCT01465490|Behavioral|Monitoring and Feedback Intervention|Clients participate in standard treatment and complete the MMI weekly with their counselors at the beginning of each individual counseling session. Counselors have been trained to administer the MMI and will have access to the data to use during sessions.
16190848|NCT01465477|Biological|Inactivated split virion Influenza vaccine|WHO recommended 2011 Influenza vaccine
16190849|NCT01465477|Biological|WHO recommended 2011 Influenza vacccine|WHO recommended 2011 Influenza vacccine
16190850|NCT01465464|Drug|Orantinib (TSU-68)|200 mg (1 tablet) of Orantinib was administered orally twice per day after meals, morning and evening.
16190851|NCT01465464|Drug|Placebo|1 tablet was administered orally twice per day after meals, morning and evening.
16190852|NCT01465451|Procedure|curative resection for colorectal cancer|right hemicolectomy for right colon cancer, transverse colectomy for transverse colon cancer, left hemicolectomy for left colon cancer, sigmoid colectomy for sigmoid colon cancer, and anterior resection or abdominal-perineal resection for rectal cancer.
16190853|NCT01465451|Drug|intra-operative 5-FU chemotherapy|"5-FU, 1000 mg/m2, injection into bowel lumen at the beginning of resection 5-FU, 200 mg/m2, injection into portal vein via mesentery vein at the end of tumor removal and bowel reconstruction.
~5-FU, 300 mg/m2, left in abdominal cavity before incision closure. surgical procedures will be the same as described in ARM A."
16190854|NCT01465438|Drug|Adalimumab|Adalimumab 40 mg every other week
16190855|NCT01465412|Drug|Preladenant|After at least an 8 hours overnight fast, one 5-mg preladenant tablet, is administered orally, on Day 1.
16190856|NCT01465399|Biological|Plasma Rich in Growth Factors PRGF-Endoret|
16190857|NCT01465399|Procedure|Conventional closure of the lesion|
16190858|NCT01465386|Drug|bortezomib|Given SC
16190859|NCT01465373|Drug|Endometrin|100 mg per vagina TID
16190860|NCT01465373|Drug|Progesterone in Oil|50 mg IM injection daily
16190861|NCT01465347|Drug|Trans Sodium Crocetinate (TSC)|TSC administered intravenously as a bolus injection prior to radiation therapy sessions during 6 weeks of radiotherapy.
16190862|NCT01465334|Drug|Ofatumumab|
16190863|NCT01465334|Drug|High-Dose Methylprednisolone|
16190864|NCT01465334|Drug|Alemtuzumab|
16190865|NCT01465308|Dietary Supplement|Honey mouthwash|The patients in the intervention group will receive honey mouthwash 15 minutes before the radiotherapy session, 15 minutes after and 6 hours after the radiotherapy session
16190866|NCT01465308|Other|Normal Saline|Saline rinses 15 minutes before radiotherapy, 15 minutes after, and 6 hours after radiotherapy
16190867|NCT01465295|Device|Mechanical hemiepiphysiodesis using the HemiBridge System|Surgical application of mechanical hemiepiphysiodesis using the HemiBridge device.
16190868|NCT01465282|Drug|CT327 0.05%|0.05% CT327 (w/w) ointment
16190869|NCT01465282|Drug|CT327 0.1%|0.1% CT327 (w/w) ointment
16190870|NCT01465282|Drug|CT327 0.5%|0.5% CT327 (w/w) ointment
16190871|NCT01465282|Drug|Placebo|Placebo
16190872|NCT01465269|Behavioral|Group Interactive Structured Treatment|GIST groups consist of 8 group participants and two group therapists. Group members receive the workbook and are asked to bring it to each session. During each of the 13, 1.5 hour sessions, key concepts from the previous session are reviewed, a new topic is discussed, strategies and skills are practiced interactively, and real-life social problems are addressed. Previously covered topics are integrated into each session through discussion and problem solving to provide repetition and reinforcement of information.
16190873|NCT01465269|Behavioral|Alternative Intervention|Participants in the alternative treatment will attend 13 weekly classroom sessions, where they will view video presentations of the same curriculum topics covered in the GIST workbook. The group therapists will serve as moderators and will meet with participants individually. Group interaction will not be encouraged. Homework exercises will be offered but participants will not be asked to return their homework and will not receive any feedback.
16190874|NCT01465256|Drug|Aspirin|Aspirin hold for a certain period of time in the patients who take aspirin for the primary prevention of vascular disease,
16190875|NCT01465243|Drug|Icotinib|125 mg Tid (375 mg per day) 250 mg Tid (750 mg per day)
16190876|NCT01465230|Drug|Maintenance lenalidomide|Daily maintenance treatment, oral lenalidomide
16190877|NCT01465217|Behavioral|text message medication reminders|daily medication reminders for one month
16190878|NCT01465204|Behavioral|Total Sanitation and Sanitation Marketing|"Total Sanitation and Sanitation Marketing (TSSM) program is designed to promote demand for and supply of improved sanitation. On the demand side, it includes Community-Led Total Sanitation (CLTS). On the supply side, TSSM incorporates sanitation marketing interventions. Both CLTS and sanitation marketing draw heavily on the behavior-change communication and social marketing approaches that have been well developed in other sectors. The basic TSSM approach also builds sustainability and scalability through the strengthening of the national level sanitation sector enabling environment."
16190879|NCT01465204|Behavioral|Scaling Up Handwashing Behavior Change|The Handwashing with soap (HWWS) behavior change program expands and improves existing hygiene behavior change efforts with new and innovative promotional approaches in order to generate widespread and sustained improvement in handwashing with soap practices. These approaches include social marketing to deliver handwashing messages; broad and inclusive partnerships with government, private commercial marketing channels, and concerned consumer groups and NGOs.
16190880|NCT01465191|Drug|Morphine|Morphine will be given via spinal injection at doses of 50, 100, 150 micrograms as part of a spinal anesthetic for cesarean section
16190881|NCT01465178|Dietary Supplement|cholecalciferol|2000 IU cholecalciferol gelcaps by mouth daily
16190882|NCT01465178|Dietary Supplement|Placebo|matching placebo
16190883|NCT01465152|Drug|metformin|Adminstered orally during the three main meals for 24 weeks
16190884|NCT01465152|Drug|repaglinide|Administered orally before the three main meals for 24 weeks
16190885|NCT01465139|Drug|CDX-301|"CDX-301, administered in multiple dosages and frequencies depending on arm:
~n=3-6 at between 1-75 μg/kg over 5 days
~n=3-6 at 25 μg/kg over 7 days
~n=3-6 at 25 μg/kg over 10 days"
16190886|NCT01465113|Drug|Omeprazole|28-day run-in phase during which subjects are treated with a proton pump inhibitor (omeprazole 20 mg po q day or an equivalent dose of another proton pump inhibitor).
16190887|NCT01465113|Drug|Vitamin D3|These patients (indefinite for dysplasia, LGD, or no dysplasia) will take vitamin D3 50,000 IU once a week for 12 weeks following the upper endoscopy.
16190888|NCT01465113|Drug|Vitamin D3|Due to the risk of progression, subjects with Barrett's esophagus with high grade dysplasia will take vitamin D3 50,000 IU once a week for 2 weeks.
16190889|NCT01465113|Procedure|upper endoscopy|After the run-in phase subjects will undergo an upper endoscopy for Barrett's surveillance or Barrett's mapping as part of routine clinical care. At the time of endoscopy, in addition to large cup forceps biopsies obtained for surveillance or mapping as part of standard care, research biopsies will be obtained for the study. Following vitamin D3 supplementation, all subjects will undergo a repeat upper endoscopy for additional large cup forceps biopsies for measurement of post-treatment mucosal levels.
16190890|NCT01465113|Drug|Metformin|500mg for the first week, 1000mg during the second week, 1500mg during the third week, maximum dose of 2000mg in the fourth week
16190891|NCT01465100|Radiation|Preparative Radiation Therapy|Subjects will undergo CT-based simulation and treatment planning for radiation therapy. Once a suitable hepatocyte donor is found and the cell count and viability is acceptable for transplantation, patients will receive Intensity-Modulated Radiation Therapy (IMRT) in one fraction(10 Gy)to the right lobe of the liver (but not exceeding 50% of the liver mass).
16190892|NCT01465100|Procedure|Hepatocyte Transplant|"Transplantation of hepatocytes into the liver will be through the portal vein, either accessed transhepatically, or by umbilical vein. After cell transplantation, measures will be taken to provide chronic access to the portal venous circulation system. If chronic access is achieved, patients will be seen in the PCTRC once a week to assess the site.
~Hepatocytes from more than one donor may be required to provide sufficient numbers of cells for transplantation to correct the disease process and to optimize Phe tolerance. Hepatocytes will be infused until the goal number of hepatocytes is infused. If viable hepatocytes remain after the goal number has been infused, the remaining cells will also be infused, as tolerated by the patient."
16190893|NCT01465100|Drug|Immunosuppression|Following transplantation, patients will be treated with conventional immune suppression, as is used following whole organ liver transplantation. Patients will be followed as routinely performed following organ transplantation and also followed as would normally be performed for their PKU.
16190894|NCT01465100|Other|Liver Evaluation|Prior to the hepatocyte transplant subjects will undergo a liver evaluation which is standard for all patients who have whole organ transplants at Children's Hospital of Pittsburgh of UPMC. The evaluation includes immunosuppression medication education, psychological assessment, bloodwork to assess blood count, blood and tissue type, blood chemistries, immune system function and certain infectious diseases, EKG, chest x-ray, and abdominal ultrasound to assess blood flow to the blood vessels in the liver. A liver biopsy may be performed if, in the clinical judgment of the investigators, the subject shows clinical signs of liver failure, or is at increased risk for liver fibrosis.
16190895|NCT01465100|Behavioral|Neuro-psychological Assessment|Subjects will undergo a repeat neuropsychological assessment at 6, 12 and 24 months post-transplant (Visits 4 and 6 and the End of Study Visit) which will be compared to results obtained pre-transplant to determine whether an improvement in assessment scoring is associated with the transplant procedure.
16190896|NCT01465100|Diagnostic Test|Whole body Phe oxidation testing|Patient will again be asked to not eat or drink for at least four hours prior to testing. Isotopic monitoring of whole body Phe oxidation will be performed pre-transplant and at every follow-up visit following the final hepatocyte infusion. An additional Phe oxidation test may also be completed in the event of suspected graft rejection.
16190897|NCT01465100|Procedure|Liver Biopsy|Liver biopsies will be performed at 3 and 12 months post-transplant to assess for the presence of donor hepatocytes, and may be completed in the event of suspected graft rejection.
16190898|NCT01465087|Other|NA-NOSE artificial olfactory system|NA-NOSE is an artificial olfactory system that is based on nanomaterials and connected with machine learning. NA-NOSE can diagnosis diseases or disorders based on volatile biomarkers that are emitted from exhaled breath, blood, or from clinical tissue.
16190899|NCT01465074|Drug|Nicotine polacrilex|4 mg
16190900|NCT01465074|Drug|Regular chewing gum; Dentyne Ice, Wrigely´s Mint Gum|30 min chewing, one dose
16190901|NCT01465061|Behavioral|Online support group|Joining online support group
16190902|NCT01465048|Biological|Plasmodium falciparum sporozoites 2sites|Aseptic, purified, cryopreserved Plasmodium falciparum sporozoites, 2,500 sporozoites, 50ulx2, 2 intradermal injection sites
16190903|NCT01465048|Biological|Plasmodium falciparum sporozoites 1 site|Aseptic, purified, cryopreserved Plasmodium falciparum sporozoites, 2,500 sporozoites, 50ulx2, 2 intramuscular injection sites
16190904|NCT01465048|Biological|Plasmodium falciparum sporozoites 1site|Aseptic, purified, cryopreserved Plasmodium falciparum sporozoites, 25,000 sporozoites, 50ulx2, 2 intramuscular injection sites
16190905|NCT01465035|Biological|TIV and MVA-NP+M1|1.5 x 108 pfu MVA-NP+M1, intramuscular injection into the thigh. Inactivated Influenza Vaccine (Split Virion) 0.5ml (containing 15 micrograms of haemagglutinin, intramuscular injection into the thigh
16190906|NCT01465035|Biological|Saline placebo and seasonal influenza vaccine TIV|Saline placebo, intramuscular injection into the thigh. Inactivated Influenza Vaccine (Split Virion) 0.5ml (containing 15 micrograms of haemagglutinin, intramuscular injection into the thigh
16190907|NCT01465022|Drug|Combined estrogen-progestin pill|1 mg norethindrone and .035 mg ethinyl estradiol orally for 21 days followed by 7 days of placebo
16190908|NCT01465022|Drug|Progestin-only pill|.35 mg norethindrone once a day orally
16190909|NCT01465009|Drug|Acetylsalicylic acid (Aspirin, BAYE4465)|Single Administration of 2 tablets Acetylsalicylic acid (500 mg each); in addition, 2 tablets matching placebo to Paracetamol
16190910|NCT01465009|Drug|Paracetamol|Single Administration of 2 tablets Paracetamol (500 mg each); in addition, 2 tablets matching placebo to Acetylsalicylic Acid
16190911|NCT01465009|Drug|Placebo|Single Administration of 2 tablets matching Placebo to Acetylsalicylic Acid together with 2 tablets matching placebo to Paracetamol
16190912|NCT01464996|Procedure|Adhesive: OptiBond XTR; Composite: Herculite Ultra|The intervention in Arm 1 (Adhesive: OptiBond XTR; Composite: Herculite Ultra) is a 2-step, self-etching adhesive.
16190913|NCT01464996|Procedure|Adhesive: OptiBond FL; Composite: Herculite Ultra|Arm 2 (Adhesive: OptiBond FL; Composite: Herculite Ultra) is a 3-step, etch-and-rinse adhesive.
16190914|NCT01464983|Drug|Acetylsalicylic acid (Aspirin, BAYE4465)|Acetylsalicylic acid 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Acetylsalicylic acid, and 2 Placebo tablets of Ibuprofen
16190915|NCT01464983|Drug|Acetylsalicylic acid (Aspirin, BAYE4465)|Acetylsalicylic acid 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Ibuprofen
16190916|NCT01464983|Drug|Ibuprofen|Ibuprofen 200 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Ibuprofen, and 2 Placebo tablets of Acetylsalicylic Acid
16190917|NCT01464983|Drug|Ibuprofen|Ibuprofen 2 x 200 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Acetylsalicylic Acid
16190918|NCT01464983|Drug|Placebo|2 Placebo tablets of Acetylsalicylic Acid, and 2 Placebo tablets of Ibuprofen, orally, single dose
16190919|NCT01464970|Procedure|Both Superficial Inferior Artery and Vein Clamped|Perfusion assessed in Zone IV of the DIEP flap whilst both the contralateral Superficial Inferior Epigastric Artery and Vein are clamped
16190920|NCT01464970|Procedure|Superficial Inferior Epigastric Vessels both unclamped|Perfusion assessed in Zone IV of the DIEP flap whilst both the contralateral Superficial Inferior Epigastric Artery and Vein are unclamped
16190921|NCT01464970|Procedure|SIE Artery Unclamped, Vein Clamped|Perfusion assessed in Zone IV of the DIEP flap whilst the contralateral Superficial Inferior Epigastric Artery is unclamped and the Vein is clamped
16190922|NCT01464970|Procedure|SIE Artery clamped, Vein unclamped|Perfusion assessed in Zone IV of the DIEP flap whilst the contralateral Superficial Inferior Epigastric Artery is clamped and the Vein is unclamped
16190923|NCT01464957|Behavioral|Semi-tailored newsletter|Delivered over 3 consecutive years, in the spring
16190924|NCT01464944|Drug|Acetylsalicylic acid (Aspirin, BAYE4465)|Acetylsalicylic acid 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Acetylsalicylic acid, and 2 Placebo tablets of Paracetamol
16190925|NCT01464944|Drug|Acetylsalicylic acid (Aspirin, BAYE4465)|Acetylsalicylic acid 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Paracetamol
16190926|NCT01464944|Drug|Paracetamol|Paracetamol 500 mg orally, single dose, 1 tablet; in addition, 1 Placebo tablet of Paracetamol, and 2 Placebo tablets of Acetylsalicylic Acid
16190927|NCT01464944|Drug|Paracetamol|Paracetamol 2 x 500 mg orally, single dose, 2 tablets; in addition, 2 Placebo tablets of Acetylsalicylic Acid
16190928|NCT01464944|Drug|Placebo|2 Placebo tablets of Acetylsalicylic Acid, and 2 Placebo tablets of Paracetamol, orally, single dose
16190929|NCT01464931|Drug|Denosumab|Adminstered by subcutaneous injection
16190930|NCT01464918|Device|Endoscopic submucosal dissection (ESD) using device, MASTER|Performing endoscopic submucosal dissection (ESD)of the gastric/colon cancer using the device, MASTER
16190931|NCT01464905|Biological|NU100|0.25 mg SQ, every other day for 12 months
16190932|NCT01464905|Biological|Placebo|1 mL SQ, every other day for 4 months
16190933|NCT01464905|Biological|rhIFN beta-1b|0.25 mg SQ, every other day for 12 months
16190934|NCT01464892|Behavioral|Imagery Rescripting and Reprocessing Therapy|This intervention is comprised of 16 sessions (twice a week) of trauma-focused imagery rescripting
16190985|NCT01464515|Device|H-Coil Deep TMS|this group will receive high frequency treatment of deep TMS with 10Hz
16193977|NCT01441947|Drug|Fulvestrant|part of combination arm
16190935|NCT01464892|Behavioral|STAIR + Imagery Rescripting|A two-phased treatment. Phase 1 is comprised of 8 (weekly) sessions of Skills Training in Affective and Interpersonal Skills (STAIR). Phase 2 consists of 16 sessions (twice weekly) of trauma-focused imagery rescripting.
16190936|NCT01464879|Drug|Testosterone Gel (FE 999303)|
16190937|NCT01464866|Other|Nutritional Supplement|Liquid, pediatric nutritional supplement. 1-2 bottles/day for up to 28 days.
16190938|NCT01464866|Other|Hospital food|Typical hospital food given daily at meals
16190939|NCT01464853|Other|Enteral nutrition with fatty acids|Enteral Feeding to provide 25 kcal/Kg/day
16190940|NCT01464853|Other|Standard Enteral Nutrition|Enteral Feeding to provide 25 kcal/Kg/day
16190941|NCT01464840|Drug|Azithromycin|500 mg intravenous infused over 1 hour
16190942|NCT01464827|Drug|ABT-450|ABT-450 tablets
16190943|NCT01464827|Drug|ABT-333|ABT-333 tablets
16190944|NCT01464827|Drug|ABT-267|ABT-267 tablets
16190945|NCT01464827|Drug|Ribavirin|Ribavirin tablets administered at a weight-based dose, between 1,000 to 1,200 mg daily (divided).
16190946|NCT01464827|Drug|Ritonavir|Ritonavir capsules
16190947|NCT01464814|Dietary Supplement|probiotic plus fish oil capsule|Lactobacillus casei (4B CFU) plus fish oil capsule, T.I.D., for seven (7) days.
16190948|NCT01464814|Dietary Supplement|Fish oil capsule|Fish oil capsule, T.I.D., for seven (7) days
16190949|NCT01464801|Dietary Supplement|Resveratrol|Tablet Resveratrol 500 mg 3 times daily for 6 months
16190950|NCT01464801|Dietary Supplement|Placebo|Tablet Placebo 3 times daily for 6 months
16190951|NCT01464788|Drug|Low Dose Argatroban|100 micrograms/kilogram bolus, followed by 1 microgram/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
16190952|NCT01464788|Drug|High Dose Argatroban|100 micrograms/kilogram bolus, followed by 3 micrograms/kilogram/minute IV infusion for 48 hours and rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
16190953|NCT01464788|Drug|rt-PA (alteplase)|rt-PA (alteplase) 0.9mg/kg (max dose 90mg) - 10% bolus, then 90% over 1-hour
16190954|NCT01464775|Other|Narrow Band Imaging (NBI)|Women will be randomized to white light/NBI versus white light/white light laparoscopic surgery
16190955|NCT01464775|Other|Standard White Light Laparoscopy|Women will be randomized to white light/NBI versus white light/white light laparoscopic surgery
16190956|NCT01464762|Drug|TMC207|400mg once daily by mouth for 2 weeks followed by 200mg by mouth three times per week for 22 weeks + individualized background of antibacterial drugs
16190957|NCT01464749|Behavioral|Task-oriented circuit class training|5 sessions/week over 2 weeks (10 sessions) 120 minutes/each
16190958|NCT01464749|Behavioral|usual care|no specific rehabilitation
16190959|NCT01464736|Other|physical training|For both groups, the approximately hour-long sessions occurred three times a week on alternate days for six consecutive weeks (18 sessions). Each session began with five minutes of stretching that included the cervical muscles and the upper and lower limbs, which was followed by five minutes of warm-up on a treadmill at 2Km/h and 30 minutes of aerobic physical training at a constant 3% incline.
16190960|NCT01464723|Drug|Ranibizumab|Intravitreal injections of 0.5 mg ranibizumab administered monthly for the first 4 months, and then as needed for a total duration of 12 months.
16190961|NCT01464697|Drug|Oral micronized progesterone|300 mg as 3-100 mg capsules taken orally at bedtime daily for 12 weeks
16190962|NCT01464697|Drug|placebo|placebo comparator, taken as 3 round capsules at bedtime daily for 12 weeks
16190963|NCT01464671|Drug|Bivalirudin|Anticoagulation during percutaneous coronary intervention
16190964|NCT01464671|Drug|Heparin|Anticoagulation during percutaneous coronary intervention
16190965|NCT01464658|Procedure|panniculectomy|surgery
16190966|NCT01464645|Device|Modular Revision Hip System|Hip System that is indicated for patients whose bone stock is of poor quality or inadequate for other reconstruction techniques as indicated by deficiencies of the femoral head, neck or portions of the proximal femur.
16190967|NCT01464632|Device|EPIK™ uni-compartmental knee|This device is intended for partial replacement of the articulating surfaces of the knee when only one side of the joint is affected due to compartmental primary degenerative or post-traumatic degenerative disease, previous tibial condyle or plateau fractures, deformity, or revision of previous arthroplasty.
16190968|NCT01464619|Other|The Incredible Years Parenting Intervention|The Incredible Years Parents, Babies, and Toddlers Program is a validated group parenting education program, which has been adapted for use with depressed caregivers by inclusion of psychoeducational depression materials.
16190969|NCT01464619|Other|Delayed Intervention|Caregivers assigned to delayed intervention will be assigned to the Incredible Years parenting intervention 3-4 months after enrollment.
16190970|NCT01464606|Drug|Vincristine|≥ 3 years: 1.5 mg/m2 IV x 1 (maximum dose 2 mg)
16190971|NCT01464606|Drug|Dactinomycin|≥ 3 years: 0.045 mg/kg (maximum dose 2.5 mg) IV X 1
16190972|NCT01464606|Drug|Cyclophosphamide|≥ 3 year: 1.2 gm/m2/dose IV as 1 hr infusion with IV fluids
16190973|NCT01464606|Drug|Ifosfamide|≥ 3 years: 3 g/m2/dose IV over 3 hours on Days 1, 2, (6 g/m2/cycle)
16190974|NCT01464606|Drug|Doxorubicin|≥ 3 years: 30 mg/m2/dose IV over 30 min, Days 1, 2 (60 mg/m2/cycle)
16190975|NCT01464593|Drug|Lyso-Thermosensitive Liposomal Doxorubicin|Thermally sensitive liposomal doxorubicin 50 mg/m2 single 30 minute intravenous infusion.
16190976|NCT01464593|Other|5% Dextrose Solution|Single 30 minute intravenous infusion
16190977|NCT01464593|Drug|ThermoDox|ThermoDox is a Lyso-thermosensitive Liposomal Doxorubicin designed to be used in conjunction with thermal ablation.
16190978|NCT01464567|Procedure|"T Tube Spontaneous Breathing Trial"|"T Tube ventilation for 30 minutes"
16190979|NCT01464567|Procedure|Pressure Support Ventilation|Pressure-Support Ventilation for 30 minutes
16190980|NCT01464554|Behavioral|Usual care|alcohol and drug education
16190981|NCT01464554|Behavioral|Project Free Talk|motivational interviewing alcohol and drug program
16190982|NCT01464541|Procedure|operative fracture size vs CT fracture size|comparing actual intraoperative fracture size to the CT fracture size
16190983|NCT01464541|Procedure|orbital fracture intraoperative measurement|comparing intraoperative fracture size to the CT orbital fracture size
16190986|NCT01464515|Device|SHAM Coil TMS|this group will receive SHAM treatment of deep TMS
16190988|NCT01464502|Procedure|Pressure-wire guided CRT implant|A pressure wire will be sited in the left ventricle to measure dP/dT max. The LV lead position that gives the highest dP/dT max will be the final position used.
16190989|NCT01464489|Drug|Atropine|"Anaesthesia was induced with alfentanil 10 μg.kg-1, propofol 2.5 mg.kg-1 and rocuronium 0.3 mg.kg-1.
~Atropine(atropine sulphate) 10 μg.kg-1, intravenous injection during induction After 120 sec of atropine injection, record intubating condition"
16190990|NCT01464489|Drug|Normal saline|Anaesthesia was induced with alfentanil 10 μg.kg-1, propofol 2.5 mg.kg-1 and rocuronium 0.3 mg.kg-1 Normal saline intravenous injection during anesthetic induction After 120 sec of normal saline injection, record intubating condition
16190991|NCT01464476|Drug|Azimilide Dihydrochloride|Azimilide 75 mg. Once daily, oral administration
16190992|NCT01464476|Drug|Placebo|Dose-matched placebo. Once daily, oral administration
16190993|NCT01464463|Behavioral|CBT - active|Patients get CBT treatment combined with moderate physical exercise (4x40min/week for 4 weeks, week 5, 6, 7 and 8).
16190994|NCT01464463|Behavioral|CBT - euthymic|Patients get the same common CBT treatment as group I, but instead of physical exercise they receive an enjoyment training Patients get CBT treatment combined with euthymic exercise (4x40min/week for 4 weeks, week 5, 6, 7 and 8).
16190995|NCT01464463|Behavioral|CBASP|"Cognitive Behavioral Analysis System of Psychotherapy integrates behavioral, cognitive, psychodynamic and interpersonal strategies.
~Foci of the CBASP-therapy are situation analysis and subsequent behavioral trainings as well as interpersonal strategies to create a therapeutic relationship."
16190996|NCT01464450|Drug|Rivaroxaban|Single 20 mg-dose
16190997|NCT01464437|Drug|AMG 151|Drug: AMG 151 50 mg BID
16190998|NCT01464437|Drug|Placebo|Placebo
16190999|NCT01464437|Drug|Metformin|Subjects will remain on their metformin regimen throughout the study. The metformin dose must be ≥ 850 mg/day for at least 2 months immediately prior to randomization.
16191000|NCT01464437|Drug|AMG 151|Drug: AMG 151 100 mg BID
16191001|NCT01464437|Drug|AMG 151|Drug: AMG 151 200 mg BID
16191002|NCT01464437|Drug|AMG 151|Drug: AMG 151 100 mg QD
16191003|NCT01464437|Drug|AMG 151|Drug: AMG 151 200 mg QD
16191004|NCT01464437|Drug|AMG 151|Drug: AMG 151 400 mg QD
16191005|NCT01464424|Drug|Travoprost 0.004% ophthalmic solution|
16191006|NCT01464424|Drug|Bimatoprost 0.01% ophthalmic solution|
16191007|NCT01464398|Behavioral|Stress reduction|8 weekly sessions
16191008|NCT01464398|Behavioral|Stress reduction with Health education|8 weekly sessions
16191009|NCT01464385|Other|Nutritional Beverage|Nutritional Beverage Oral 237mL
16191010|NCT01464385|Other|Nutritional Beverage|Nutritional Beverage Oral 237 mL
16191011|NCT01464385|Other|Nutritional Beverage|Nutritional Beverage Oral 237mL
16191012|NCT01464372|Device|Electrical Field Stimulation Device|Treatment with Electrical Field Stimulation Device
16191013|NCT01464372|Device|Sham Nerve Stimulation Device|Use of the sham device
16191014|NCT01464359|Drug|Allopurinol|On Day 8 pre-transplant, start hydration with allopurinol per standard of care.
16191015|NCT01464359|Drug|Fludarabine|On Days 7, 6 and 5 pre-transplant, 25 mg/m^2 intravenously over 1 hour.
16191016|NCT01464359|Radiation|Total body irradiation|On Days 5, 4, 3, and 2 pre-transplant, 165 cGy times 2 (330 cGy daily, 1320 total dose) according to the University Of Minnesota Blood and Marrow Transplant Program total body irradiation (TBI) guidelines.
16191017|NCT01464359|Drug|Cyclophosphamide|"On Days 7 and 6 pre-transplant, 60 mg/kg intravenously (IV) over 2 hours with a high volume fluid flush and mesna per institutional guidelines.
~Alternate Preparative Therapy For Patients Not Able To Receive TBI: Days 5, 4, 3 and 2 pre-transplant; 50 mg/kg/day IV over 2 hours."
16191018|NCT01464359|Drug|Levetiracetam|Alternate Preparative Therapy for Patients Not Able to Receive Total Body Irradiation (TBI): Hydration therapy on Day 10 pre-transplant.
16191019|NCT01464359|Drug|Busulfan|Alternate Preparative Therapy For Patients Not Able To Receive TBI: Days 9, 8, 7 and 6 pre-transplant; 0.8 mg/kg (1.1 mg/kg if <12 kg) intravenously every 6 hours
16191020|NCT01464359|Biological|Umbilical Cord Blood Transplantation|Day 0: Two UCB units will compose the graft. The infusion of the first UCB unit should begin within 15 minutes, and no later than 30 minutes after arrival on the Unit. The UCB unit without IL-2 activation will be infused first, followed by the IL-2 activated unit. Both cords will be infused within 30-60 minutes of each other as deemed clinically safe by the BMT attending.
16191021|NCT01464359|Biological|Interleukin-2|"First Course of IL-2 (begin day +3) post-transplant: For patients ≥ 45 kg, IL-2 will be given at 9 million units every other day for a total of 6 doses subcutaneously. Patients weighing less than 45 kilograms, the IL-2 will be dosed at 5 million units/m^2 every other day for a total of 6 doses.
~Second Course of IL-2 (day +60):
~Patients will receive a second course of IL-2 beginning on Day +60 post transplant to expand and educate the NK cells derived from the UCB graft source."
16191022|NCT01464346|Device|Enlite Sensor|This is the Enlite sensor (all subjects)
16191023|NCT01464320|Drug|ABT-614|Active
16191024|NCT01464320|Drug|Placebo Comparator|Placebo
16191025|NCT01464307|Drug|IncobotulinumtoxinA (400 Units)|Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection.
16191026|NCT01464307|Drug|Placebo Comparator|Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection
16191027|NCT01464294|Device|Milled ceramic restorations|Restoration of back teeth with milled ceramic crowns or onlays
16191028|NCT01464294|Device|Milled nano-composite restorations|Restoration of back teeth with milled crowns or onlays
16191029|NCT01464281|Drug|Peginterferon alfa 2a|Group 1 : 48-week standard treatment by Peginterferon alfa 2a 180µg/week Group 2 : 96-week prolonged treatment by Peginterferon alfa 2a 180µg/week.
16191030|NCT01464268|Drug|Riboflavin|Administration of riboflavin every 2 minutes for the duration of UV exposure.
16191031|NCT01464268|Drug|Riboflavin|Administration of riboflavin every 1 minute for the duration of UV exposure.
16191032|NCT01464255|Device|ocufilcon D|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
16194319|NCT01439373|Drug|Ribavirin|Standard of Care drug
16191033|NCT01464255|Device|ocufilcon B|Participants wear a first pair of lenses for one week and then crossover and wear an alternate second pair of lenses for one week.
16191034|NCT01464242|Drug|Meglumine antimonate|Glucantime® 20mg/kg/day IM daily for 20 days
16191035|NCT01464242|Drug|Placebo|Placebo 400mg orally 3 times a day for 20 days
16191036|NCT01464242|Drug|Pentoxifylline|Pentoxifylline 400mg orally 3 times a day for 20 days
16191037|NCT01464229|Drug|Iloperidone|Iloperidone 1-8 mg for 4 weeks
16191038|NCT01464229|Drug|Placebo|Placebo
16191039|NCT01464203|Other|CT coronary angiography|"CT coronary angiography:
~This allows two distinct assessments of the coronary arteries to be made:
~coronary calcium scan, which is a 30 second, low-radiation scan that allows reproducible quantification of the amount of calcium in the coronary arteries to be made.
~contrast enhanced CT coronary angiogram. This is a quick, non-invasive scan to assess the patency of coronary arteries."
16191040|NCT01464203|Other|Standard of Care|The management of patients in this group is according to the NHS protocol and is not altered by their participation in the trial. The choice of diagnostic investigation for CAD is determined by the patient's clinical scenario and the availability of different diagnostic modalities in the recruiting hospital.
16191041|NCT01464190|Drug|PA21 (2.5 g tablet containing 500 mg iron)|Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
16191042|NCT01464190|Drug|Sevelamer carbonate|Film coated, compressed tablets. Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day).
16191043|NCT01464177|Radiation|Stereotactic hypofractionated RT 5x5Gy|"Stereotactic hypofractionated radiation therapy delivered as follows:
~Gross tumor volume (GTV) equals enhancement area in T1 contrast enhanced MRI.
~Planning tumor volume (PTV) equals GTV plus 3mm margin.
~The dose of radiation will be 25Gy delivered in 5 fractions.1 fraction per day, non consecutive days in a maximum period of 10 working days.
~RT to begin in a maximum of 2 weeks after randomization"
16191044|NCT01464177|Radiation|Stereotactic hypofractionated RT 5x7Gy|"Stereotactic hypofractionated radiation therapy delivered as follows:
~Gross tumor volume (GTV) equals enhancement area in T1 contrast enhanced MRI.
~Planning tumor volume (PTV) equals GTV plus 3mm margin.
~The dose of radiation will be 35Gy delivered in 5 fractions.1 fraction per day, non consecutive days in a maximum period of 10 working days.
~RT to begin in a maximum of 2 weeks after randomization."
16191045|NCT01464164|Drug|Sotatercept|"Cohort 4a: 3 patients on Sotatercept 0.75 mg/kg every 3 weeks. If the patients have no untoward events in the Patients in Dose Level 4 by the end of 3 of the 6 doses, then additional patients (Dose Level 5) will be enrolled at the next dose level:
~Cohort 5a: 3 patients on Sotatercept 1 mg/kg every 3 weeks"
16191046|NCT01464164|Drug|Sotatercept with prednisone boost|"Cohort 4b: 3 patients on Sotatercept 0.75 mg/kg every 3 weeks with a three week prednisone boost of 1 mg/kg/day (max 60 mg). If the patients have no untoward events in the Patients in Dose Level 4 by the end of 3 of the 6 doses, then additional patients (Dose Level 5) will be enrolled at the next dose level:
~Cohort 5b: 3 patients on Sotatercept 1 mg/kg every 3 weeks with a 3 week prednisone boost of 1 mg/kg/day (max 60 mg)."
16191047|NCT01464138|Drug|Fosmidomycin and Clindamycin co-administration|Fosmidomycin sodium syrup at a concentration of 250mg/5ml and clindamycin hydrochloride syrup at a concentration of 75mg/5ml. Administered in doses of fosmidomycin 30mg/kg/dose + clindamycin 10mg/kg/dose twice daily for three days (total daily dose fosmidomycin 60mg/kg, clindamycin 20mg/kg)
16191048|NCT01464125|Drug|Fosmidomycin|Fosmidomycin sodium capsules 450 mg x 4 twelve-hourly for three days
16191049|NCT01464125|Drug|Azithromycin|Azithromycin capsules 250 mg x 3 twelve-hourly for three days
16191050|NCT01464112|Drug|JNJ-2641585 / VELCADE / Dexamethasone|JNJ-26481585: type=range, unit=mg, number=6 to 12, form=capsules, route=oral use, on Days 1, 3, and 5 of each week. VELCADE: type=exact, unit=mg/m2, number=1.3, form=powder for solution for injection, route=subcutaneous use, on Days 1, 4, 8, and 11 of each 21-day cycle (Cycles 1 to 8) and on Days 1, 8, 15, and 22 of each 35-day cycle (Cycles 9-11). Dexamethasone: type=exact, unit=mg, number=20, form=tablets, route=oral use, on the day of and after VELCADE.
16191051|NCT01464099|Drug|insulin aspart|An initial priming dose of insulin aspart is administered, then a continuous subcutaneous insulin aspart infusion followed by a bolus of insulin aspart on top of the continuous insulin aspart infusion
16191052|NCT01464099|Drug|insulin aspart|An initial priming dose of insulin aspart is administered, then a continuous subcutaneous insulin aspart infusion followed by a bolus of insulin aspart on top of the continuous insulin aspart infusion
16191053|NCT01464086|Other|whole body MRI|whole body MRI at inclusion, one and two years
16191054|NCT01464073|Behavioral|LIPOXmax|Arm 1: LIPOXmax arm. Subjects will perform a physical activity 4x1 hour per week at the optimal intensity for fat oxidation (LIPOXmax) measured by indirect calorimeter.
16191055|NCT01464073|Behavioral|60% VO2peak|Arm 2: physical activity standard arm (60% of VO2max measured by cardio respiratory exercise test). Subjects will realize 4 sessions per week and duration of sessions will be adjusted so that arms 1 and 2 have the same total energy expenditure by session.
16191056|NCT01464073|Behavioral|Good Medical Practices|"Arm 3: The subjects initially receive the recommendations of good medical practice for physical activity (achieving at least 30min per day of moderate exercise)."
16191057|NCT01464073|Dietary Supplement|supplementation in fruits and vegetables|all groups will be supplemented in fruits and vegetables (5 per day) during all the study
16191058|NCT01464060|Drug|PPI, amoxicillin, metronidazole and clarithromycin|Dual therapy for 7 days: 40 mg omeprazole and 1g amoxicillin every 12h. After dual therapy continue with a quadruple therapy for 7 days: 40 mg omeprazole, 1g amoxicillin, 500 mg metronidazole and 500 mg clarithromycin every 12h.
16191059|NCT01464060|Drug|PPI, amoxicillin, metronidazole and clarithromycin|Quadruple therapy for 14 days: 40 mg omeprazole, 1g amoxicillin, 500 mg metronidazole and 500 mg clarithromycin every 12h
16191060|NCT01464034|Drug|Carfilzomib|IV over 30 minutes on Days 1,2,8,9,15, and 16 every 28 days
16191061|NCT01464034|Drug|Pomalidomide|PO daily on Days 1-21, every 28 Days
16191062|NCT01464034|Drug|Dexamethasone|40 mg weekly PO or IV on Days 1, 8, 15, and 22, every 28 days.
16191063|NCT01464008|Drug|Pegylated interferon alfa-2a and ribavirin|all patients were given peginterferon alfa-2a (40KD) (Pegasys®; Roche, Basel, Switzerland) 135 or 180 µg by subcutaneous injection once weekly, and received twice daily oral ribavirin at a target total daily dose of 13 mg/kg/day. .
16191244|NCT01462643|Drug|LAS41004|once daily, topical ointment, 100 microgram per day
16191245|NCT01462630|Drug|pazopanib hydrochloride|Given PO
16191064|NCT01463982|Drug|Oratecan and Capecitabine|"Oratecan in combination with Capecitabine
~Irinotecan HCl Tablet - Initial dose 10 mg/m2 (may be increased up to 20 mg/m2), Day1~Day5
~HM30181AK Tablet - Fixed dose 15 mg, Day1~Day5
~Capecitabine Tablet - Initial dose 800 mg/m2 (may be increased up to 1000 mg/m2), Day1~Day14"
16191065|NCT01463956|Drug|Boceprevir|Boceprevir 200 mg capsules at 2400mg/day (800mg 3 times a day) from week 4 until week 48 or until liver transplant (can be performed from week 16)
16191066|NCT01463956|Biological|Peg-Interferon α-2b or Peg-Interferon α-2a|Peg-Interferon α-2b by subcutaneous injection, 1.5µg/kg/week, from day 0 until week 48 or until liver transplantation, or Peg-Interferon α-2a by subcutaneous injection, 180 µg, once weekly, from day 0 until week 48 or until liver transplantation
16191067|NCT01463956|Drug|Ribavirin|Ribavirin: capsules 200 mg (weight-based daily dose: <65kg, 800 mg; 65-80kg, 1000mg; 81-105kg: 1200mg; >105kg: 1400mg), from day 0 until week 48 or until liver transplantation or, Ribavirin: Tablet Oral, weight-based dose, 1000 mg for subjects weighing below 75 kg or 1200 mg for subjects weighing equal or over75 kg, once daily, from day 0 until week 48 or until liver transplantation
16191068|NCT01463943|Other|Probiotic|
16191069|NCT01463943|Other|Probiotic|
16191070|NCT01463943|Other|Probiotic|
16191071|NCT01463930|Behavioral|Educational audiovisual videodisc and medical verbal information|General and specific medical verbal information and ten-minute DVD where the process from admission to the surgical intervention, recovery room, immediate postoperative care, and outpatient care at two, six, and twelve months after surgery was shown. The video included experiences of patients with respect to pain and function and examples of functionality during daily life activities such as stairs, kneeling or squatting. The video also demonstrated the facilities and rehabilitation techniques employed in the Physical Medicine and Rehabilitation Service.
16191072|NCT01463930|Behavioral|Medical verbal information|General and specific verbal information provided by both the surgeon and a specialized nurse including basics of surgical technique, potential complications, and rehabilitation.
16191073|NCT01463917|Drug|Hypertonic solution|Use of Hypertonic solution 4 ml/Kg during left marginal branch CABG surgery.
16191074|NCT01463917|Drug|Isotonic|Use of Isotonic solution 4 ml/Kg during left marginal branch CABG surgery.
16191075|NCT01463904|Procedure|SADI-S 250|Single-Anastomosis Duodeno-Ileal bypass with Sleeve gastrectomy
16191076|NCT01463891|Drug|Eribulin Mesylate|The usual adult dose of eribulin mesylate is 1.4 mg/m^2 (body surface area) administered intravenously over 2 to 5 minutes, once daily once a week. Treatment shall be continued for 2 consecutive weeks followed by a third week of drug cessation. With each cycle lasting 3 weeks, the treatment shall be repeated. The dose may be reduced, depending on the condition of the individual patient.
16191077|NCT01463878|Dietary Supplement|Glycerna|Diabetes specific formula
16191078|NCT01463878|Dietary Supplement|Jevity - Control Diet|Control Diet
16191079|NCT01463865|Drug|ropivacaine|Single shot nerve block with ropivacaine 10-20 ml; 7,5 mg/ml
16191080|NCT01463865|Drug|Sodium chloride|Single shot nerve block with isotonic sodiumchloride 10-20 ml; 0.9%
16191081|NCT01463852|Drug|vincristine|Vincristine 2mg will be administered one time to participants. Blood samples will be collected pre and post dose.
16191082|NCT01463813|Dietary Supplement|Vitamin D3|Vitamin D3 40 micrograms (1600 IU) per day
16191083|NCT01463813|Dietary Supplement|Vitamin D3|Vitamin D3 80 micrograms (3200 IU) per day
16191084|NCT01463813|Dietary Supplement|Placebo|Inactive placebo
16191085|NCT01463800|Behavioral|Structured exercise training|12 weeks low level ambulatory structured exercise training
16191086|NCT01463787|Procedure|microsurgical varicocelectomy in inguinal approach|In inguinal approach, the incision, which was about 3cm, was made two fingers up the pubic symphysis, from external inguinal rings parallel to the inguinal ligament.
16191087|NCT01463787|Procedure|microsurgical varicocelectomy in subinguinal approach|In subinguinal approach, the incision was about 3 cm horizontal and 1 cm below the external inguinal ring.
16191088|NCT01463774|Drug|Treatment A: Canagliflozin tablet|Type=exact number, unit=mg, number=100, form=tablet, route=oral use. One canagliflozin tablet taken orally (by mouth) on Day 1 of Treatment Period A.
16191089|NCT01463774|Drug|Treatment A: Metformin IR tablets|Type=exact number, unit=mg, number=850, form=tablet, route=oral use. Two metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period A.
16191090|NCT01463774|Drug|Treatment B: Canagliflozin/metformin fixed dose combination tablets|Type=exact number, unit=mg, number=50/850, form=tablet, route=oral use. Two canagliflozin/metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period B.
16191091|NCT01463761|Device|ANS activity|This ANS activity is measured by nocturnal heart rates records with Holter ECG.
16191092|NCT01463748|Other|Graptopetalum paraguayense E. Walther|Graptopetalum paraguayense E. Walther
16191093|NCT01463748|Other|Placebo|starch
16191094|NCT01463735|Dietary Supplement|Vitamin E supplement (tocofersolan)|700 mg per day per os (i.e. 350 mg twice a day with meals)
16191095|NCT01463722|Other|Amniotic fluid Lamellar Body Counting|fluid samples were obtained by amniocentesis during normal delivery or before rupturing the membrane in cesarean. The samples were sent to the lab as soon as possible and after centrifuging with 500 round per minute for 3 minutes, they were placed in the cell counter machine (STKR coulter).
16191096|NCT01463709|Device|PulseCure pulse generator and Derm-pulse electrode|"PulseCure 100 ns pulse generator: generates 30 kV/cm electric pulses 100 ns long to trigger apoptosis in cells between the electrodes.
~NanoBlate: Delivery device to treat 5 mm wide skin lesions with 100 ns pulses from PulseCure"
16191097|NCT01463696|Drug|MK-8242|10 mg, 100 mg and 150 mg capsules
16191098|NCT01463683|Biological|2XP HEPTAVAX™-II SC|
16191099|NCT01463683|Biological|1XP HEPTAVAX™-II SC|
16191100|NCT01463683|Biological|2XP HEPTAVAX™-II IM|
16191121|NCT01463501|Other|Adjuvant chemoradiotherapy|Surgery followed by paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f), consolidate paclitaxel/carboplatin 2 cycles.
16191122|NCT01463488|Drug|SAR113945|"Pharmaceutical form:Injection
~Route of administration: Intra-articular"
16191123|NCT01463488|Drug|placebo|"Pharmaceutical form:Injection
~Route of administration: Intra-articular"
16191124|NCT01463475|Procedure|Bone marrow aspirate|A single bone marrow aspirate procedure is planned.
16191125|NCT01463449|Procedure|gastric bypass|Low grade inflammation in adipose tissue before and after gastric bypass
16191101|NCT01463670|Drug|lenalidomide|patients will begin therapy with lenalidomide 25 mg daily, 21 days out of a 28 day schedule. All patients will be evaluated monthly after every cycle. The dose will be adjusted downward in response to side effects and according to specific guidelines. Symptomatic POD occurring at any time during the study will result in removal of the patient from the study. After 2 cycles of lenalidomide, patients with at least stable disease (SD) will continue lenalidomide indefinitely until asymptomatic POD, at which time dexamethasone will be added at a dose of 40mg weekly. On the other hand, patient with asymptomatic POD after 2 cycles of lenalidomide will have dexamethasone added at a dose of 40 mg weekly. Patients with any type of POD after any cycle that includes dexamethasone will be taken off study. Patients can remain on study on lenalidomide or lenalidomide/dexamethasone indefinitely as long as they do not have POD as stated above and they tolerate the treatment.
16191102|NCT01463657|Device|Juvéderm® Ultra Plus|Patients will receive either ELAPR002b or ELAPR002d for the treatment of one NLF, and Juvéderm® Ultra Plus for the treatment of the second, opposite NLF. Treatments will be provided on Day 1 and repeated on Day 29 (if required at the discretion of the investigator) Day 57 (if required at the discretion of the investigator)to achieve OCR.
16191103|NCT01463657|Device|ELAPR002|Each treatment will consist of up 15 injections in total, each consisting of up to 0.1 ml of product, delivered to the mid to deep dermis of the skin of each NLF using a 27G needle. The needle will be inserted at an approximate angle of 30o parallel to the skin, and the product may be injected by a retrograde injection or by deposition of a bolus. ELAPR and the control may be implanted parallel or perpendicular to the NLF. Exactly the same technique will be used for the treatment of both NLFs for each patient.
16191104|NCT01463644|Drug|Mepolizumab|This is an anti IL-5 which is given once a month intravenously at the dose of 750 mg.
16191105|NCT01463644|Drug|placebo|The placebo will consist of 100 mL normal saline solution (0.9%, 154 mmol/L sodium chloride).
16191106|NCT01463631|Drug|LY3007113|Administered orally
16191107|NCT01463605|Drug|Nimotuzumab|Nimotuzumab 200mg,once per week,for 5 to 6 weeks
16191108|NCT01463592|Biological|RENESSANS , INTERFERON ALPHA 2b, Ribavirin|ORAL RENESSANS 5gm. Twice Daily +INTERFERON ALPHA 2b 3 Million Units s/c +RIBAVIRIN 15mg/kg
16191109|NCT01463592|Drug|Interferon Alfa-2b AND RIBAVIRIN|INTERFERON ALPHA 2b 3 Million Units s/c +RIBAVIRIN 15mg/kg
16191110|NCT01463592|Biological|RENESSANS|ORAL RENESSANS 5gm. Thrice Daily{active iodine 300mg} for 6months
16191111|NCT01463579|Other|Exercise Programme|"Patients will complete three exercise sessions per week (2 supervised and 1 unsupervised) for 6 weeks. They will receive a written exercise manual which facilitates completion of their exercise programme. The exercise programme will consist of a warm-up, an exercise circuit, a period of aerobic exercise, and a cool down. The programme will be tailored to each patient's ability and needs.
~At the end of the 6 weeks patients will receive a short consultation to set goals relating to continuing exercise at home."
16191112|NCT01463579|Other|Standard Care|Following ICU admission patients are discharged to hospital wards to the care of a consultant, and the patients are no longer under the care of the ICU team. They are provided with appropriate medical and nursing care, and with referral to other disciplines as necessary. One mobile and able to return home to a carer or another facility they are discharged from hospital. There is usually no support to address potential problems specific to critical illness for patients after ICU discharge.
16191113|NCT01463566|Device|Zimmer Gender(R) Solutions(TM) Natural-Knee(R) Flex System|Gender Solutions Natural Knee Flex System in total knee arthroplasty
16191114|NCT01463553|Procedure|VATS pleurodesis|Based on the findings, establish selection standards for the timing of surgery to treat PSP by VATS and establish technical specifications for performing operations on different types of lung bullae. The goal is to improve the diagnosis and treatment of PSP so as to reduce the recurrence rate of pneumothorax, reduce the trauma of operation, shorten hospital stays and postoperative recovery time, and provide better services for returning to everyday life and improving the quality of life for patients.
16191115|NCT01463540|Device|A 20 Fr gastrostomy tube, placed using push/pull techniques.|In this group a 20 Fr gastrostomy tube will be placed, of the type in use at each centre, using the push or the pull method. Positioning of the gastrostomy tube will be carried out endoscopically in sedated patients, after antibiotic prophylaxis. Single dose ampicillin/sulbactam 1g/500 mg will be infused intravenously 30 minutes before positioning. In patients just receiving antibiotic therapy, as treatment of concomitant disease, the current therapy will be continued and antibiotic prophylaxis with ampicillin/sulbactam will be not given.
16191116|NCT01463540|Device|A 20 Fr balloon type tube, placed after gastropexy.|In this group a 20 Fr balloon type gastrostomy tube will be placed endoscopically, after gastropexy performed using the Kimberly Clarke MIC Introducer kit, according to the instructions suggested by the manufacturer. The kit includes 4 T-fasteners (only 3 are usually placed in clinical use) and a serial 24 Fr dilator with a pell-away sheath. All commercially available brands of balloon type gastrostomy tubes will be allowed for use in the study. Positioning of the gastrostomy tube will be carried out in sedated patients, after antibiotic prophylaxis (Single dose ampicillin/sulbactam 1g/500 mg ev.). In patients just receiving antibiotic therapy, as treatment of concomitant disease, the current therapy will be continued and antibiotic prophylaxis will be not given.
16191117|NCT01463527|Device|Nellcor NPB-70 Capnograph|Use of capnography as an additional monitor during sedation to detect hypoventilation and apnea prior to declines in pulse oximetry and clinical examination findings
16191118|NCT01463514|Procedure|Right heart catheterization|Oxygenation and hemodynamic parameters will be assessed during RHC according to standard procedures. All measurements will be noted as usual for PH assessment including: at rest breathing room air, during an oxygen challenge, under vasodilator testing with NO and/or during exercise. Room air, supplemental oxygen and NO will be applied over common breathing mask while patient is in a supine position. Oxygen will be taken as usual from the common adjustable hospital wall access, NO will be taken according to usual clinical practice during RHC from a gas cylinder connected to a reservoir, where adequate ppm concentration can be regulated. A dose of 40 ppm NO will be used according to common practise. Oxygen delivery to maintain the peripheral oxygen saturation between 88% and 90% will be adjusted over a 3 minute period of time.
16191119|NCT01463514|Procedure|Near-infrared spectroscopy|For study purpose, patients will have additional non-invasive NIRS assessment. The measurement will take place during right heart catheterization.
16191120|NCT01463501|Other|Neoadjuvant chemoradiotherapy|Paclitaxel/carboplatin and concurrent radiation (50.4Gy/28f) followed by surgery, consolidate paclitaxel/carboplatin 2 cycles.
16191126|NCT01463436|Dietary Supplement|soy isoflavone|100 mg soy isoflavone tablet containing genistein 55%, daidzein 39% and glycitein 6% and calcium carbonate 500 mg in the experimental group for 6 months and 12 months
16191127|NCT01463436|Dietary Supplement|control group|the control group receiving tablet contain calcium carbonate 500 mg/day for 6 months and 12 months
16191128|NCT01463423|Radiation|Individualized Stereotactic Ablative Radiotherapy (iSABR)|Individualized stereotactic ablative radiotherapy (iSABR) is a radiotherapy procedure.
16191129|NCT01463397|Drug|SAR292833|"Pharmaceutical form: capsule
~Route of administration: oral"
16191130|NCT01463397|Drug|placebo|"Pharmaceutical form:capsule
~Route of administration: oral"
16191131|NCT01463384|Drug|Minocycline|50mg, twice daily for 6 months.
16191132|NCT01463371|Drug|Azithromycin|250 mg three times a week during three months
16191133|NCT01463358|Device|DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)|pacing in DDD60 is supposed to prevent events of syncope, presyncope of cardioinhibitory origin and symptom associated to av block
16191134|NCT01463358|Device|DDD60 (INSIGNIA® pacing systems Guidant (Boston Scientific)|pacing in DDDI30 is supposed to act as a safety backup upfront to episodes of syncope, presyncope or AV block, but not supposed to reduce symptoms.
16191135|NCT01463345|Other|Blood transfusion|Conservative transfusion arm: Subjects randomized to the conservative transfusion arm will receive transfusions of PRBCs post-surgery only when their Hgb level measures < 7.5 g/dl. Blood products should be given to maintain Hgb levels >7.5 g/dl.
16191136|NCT01463345|Other|Blood transfusion|Liberal transfusion arm: Subjects randomized to the liberal transfusion arm will receive transfusions of PRBCs post-surgery only when their Hgb level measures < 9.0 g/dl. Blood products should be given to maintain Hgb levels > 9.0 g/dl.
16191137|NCT01463332|Drug|I.V injection of 10 ml normal saline|Patients were randomly assigned in to three groups of 50 each using a computer-generated table of random numbers. Patients Group NS were injected intravenously with 10 ml of normal saline before injection of propofol.
16191138|NCT01463332|Drug|I.V injection with 0.25mic/kg of dexmedetomidine|Patients were randomly assigned in to three groups of 50 each using a computer-generated table of random numbers. Patients Group D25 were injected intravenously with 0.25mic/kg of dexmedetomidine diluted with normal saline into 10ml before injection of propofol.
16191139|NCT01463332|Drug|I.V injection of 0.50mic/kg of dexmedetomidine|Patients were randomly assigned in to three groups of 50 each using a computer-generated table of random numbers. Patients Group D50 were injected intravenously with 0.50mic/kg of dexmedetomidine diluted with normal saline into 10ml before injection of propofol.
16191140|NCT01463319|Other|air insufflation|air insufflation during insertion phase colonoscopy
16191141|NCT01463319|Other|warm water irrigation|warm water irrigation during insertion phase colonoscopy
16191142|NCT01463306|Drug|Pregabalin|Pregabalin administered as either capsule or liquid oral formulations. Subjects <4 years of age at Visit 1 will receive study medication 3 times daily (TID) in equally divided doses. Subjects who are ≥4 years of age at Visit 1 will receive study medication twice daily (BID) in equally divided doses. Children less than 17 years of age will receive from 2.5 mg/kg/day to 10.0 mg/kg/day (maximum 600 mg/day. Adults 17 and older will receive from 150 mg/day to 600 mg/day.
16191143|NCT01463293|Dietary Supplement|B. lactis HN019|Capsule containing 10 billion cfu B. lactis HN019 once a day
16191144|NCT01463293|Dietary Supplement|B. lactis HN019|Capsule containing 1 billion cfu B. lactis HN019 once a day
16191145|NCT01463293|Dietary Supplement|Placebo|Capsule containing no probiotic once a day
16191146|NCT01463280|Drug|tumescent lidocaine infiltration|Tumescent local anesthesia containing dilute lidocaine is infiltrated into subcutaneous tissue prior to liposuction
16191147|NCT01463267|Device|iPhone or pillbox|People will be reminded to take their medications by a device that alerts the patient to the need to take a medication.
16191148|NCT01463267|Behavioral|Non-reminding|As a comparison, the devices will collect medication taking information without providing reminders.
16191149|NCT01463241|Behavioral|Behavioral and Affective Skills in Coping (BASIC)|The investigator's seek to develop a treatment protocol that integrates five core intervention principles that are common to evidence-based treatments for youth depression, anxiety, and disruptive behavior problems. The protocol will be designed for implementation in everyday community practice settings by practitioners. The BASIC protocol will include (a) a therapist manual guiding the use of five BASIC skills [Belief Repair, Action, Solving Problems, Incentives, and Calming]; (b) child and parent materials to facilitate learning skills, practicing them in-session, and using them outside sessions; and (c) a decision tree to guide judgments about which skills to use and when to switch skills or treatment focus.
16191150|NCT01463228|Drug|A (canagliflozin and metformin IR individual tablets) / B (canagliflozin/metformin IR FDC tablets)|Treatment A: Canagliflozin: Type = 1, unit = mg, number = 300, form = tablet, route = oral use + metformin IR: Type = 2, unit = mg, number = 1000, form = tablet, route = oral use. One canagliflozin tablet and 2 metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 1 followed 10-15 days later by Treatment B (canagliflozin/metformin IR FDC): Type = 2, unit = mg, number = 150/1000, form = tablet, route = oral use. Two canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 2
16191151|NCT01463228|Drug|B (canagliflozin/metformin IR FDC tablets / A (canagliflozin and metformin IR individual tablets)|Treatment B (canagliflozin/metformin IR FDC): Type = 2, unit = mg, number = 150/1000, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 1 followed 10-15 days later by Treatment A: Canagliflozin: Type = 1, unit = mg, number = 300, form = tablet, route = oral use + Metformin IR: Type = 2, unit = mg, number = 1000, form = tablet, route = oral use. One canagliflozin tablet and 2 metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 2.
16191152|NCT01463215|Drug|Ambroxol|Ambroxol at a dose level of 187.5 or 225 mg/day will be given once daily by mouth for 2 months.
16191153|NCT01463202|Drug|Depot medroxyprogesterone acetate|Postpartum administration of DMPA (prior to hospital discharge)
16191154|NCT01463202|Drug|Depot medroxyprogesterone acetate|Delayed administration of DMPA (4-6 weeks postpartum)
16191155|NCT01463189|Behavioral|painACTION: Arthritis|"Participants will be asked to complete eight 20-minute sessions on the site over a four-week intervention period (two site visits per week), and complete five 20-minute booster sessions (one site visit per month) during the follow up period. Each session will have a minimum set of requirements. Specific details about the requirements for each session will be provided in the session logs."
16191156|NCT01463176|Behavioral|Music Therapy|Live music therapy is interactive and incorporates behavioral cues for coping techniques during the procedure, using patient-preferred music.
16191157|NCT01463163|Drug|Prasugrel|Prasugrel 60mg LD followed by 10mg x1 MD starting post 24 hours
16191158|NCT01463163|Drug|Ticagrelor|Ticagrelor 180mg LD followed by 90mg x2 MD starting after 12±6 hours
16191159|NCT01463150|Drug|Clopidogrel|Clopidogrel 150mg per day for 15 days
16191160|NCT01463150|Drug|Prasugrel|Prasugrel 5mg per day for 15 days
16191161|NCT01463137|Behavioral|Attention bias modification|All arms will consist of 10 minutes of training in front of a computer screen (192 trials) once a day for 14 days.
16191162|NCT01463124|Behavioral|Lookin' Good Feelin' Good|Six 30-minute individual student-centered counseling sessions delivered by school nurses during the first two months followed by weekly weigh-ins and monthly visits over the subsequent 6 months, plus an exercise program in the school 3 times a week for the full eight months of the intervention.
16191163|NCT01463124|Behavioral|Information attention-control|Six individual sessions with school nurse over the first two months followed by monthly visits over the remaining 6 months to check weight and behavior changes and provide a series of pamphlets on weight and weight management.
16191164|NCT01463111|Drug|Lithium|Open label treatment per standard of care for bipolar disorder for six weeks.
16191165|NCT01463111|Drug|Valproate|Open label treatment per standard of care for bipolar disorder for six weeks.
16191166|NCT01463111|Drug|Lamotrigine|Open label treatment per standard of care for bipolar disorder for six weeks.
16191167|NCT01463098|Drug|E2006 1.0 mg|E2006 1.0 mg capsule.
16191168|NCT01463098|Drug|E2006 2.5 mg|E2006 2.5 mg capsule.
16191169|NCT01463098|Drug|E2006 5.0 mg|E2006 5.0 mg (2 capsules of 2.5 mg each).
16191170|NCT01463098|Drug|E2006 10.0 mg|E2006 10.0 mg capsule.
16191171|NCT01463098|Drug|E2006 25.0 mg|E2006 25.0 mg (2 capsules of 10 mg each and 2 capsules of 2.5 mg each).
16191172|NCT01463098|Drug|E2006 50.0 mg|E2006 50.0 mg capsule.
16191173|NCT01463098|Drug|E2006 100 mg|E2006 100 mg (2 capsules of 50 mg each).
16191174|NCT01463098|Drug|E2006 200 mg|E2006 200 mg (4 capsules of 50 mg each).
16191175|NCT01463098|Drug|Zolpidem 10 mg|Zolpidem 10 mg immediate release tablet.
16191176|NCT01463098|Drug|E2006 Matched Placebo or Zolpidem Matched Placebo|E2006-matched placebo capsules or zolpidem-matched placebo tablets.
16191177|NCT01463098|Drug|E2006 Matched Placebo|E2006-matched placebo capsule.
16191178|NCT01463085|Other|Low-fat dairy|Dietary Intervention of 3 servings per day of low-fat dairy
16191179|NCT01463072|Other|Laboratory Biomarker Analysis|Correlative studies
16191180|NCT01463072|Drug|Nab-paclitaxel|Given IV
16191181|NCT01463072|Other|Questionnaire Administration|Ancillary studies
16191182|NCT01463059|Biological|Placebo|Placebo solution for injection, administered as subcutaneous injections
16191183|NCT01463059|Biological|Olokizumab 60 mg|Olokizumab 60 mg solution for injection, administered as subcutaneous injections
16191184|NCT01463059|Biological|Olokizumab 120 mg|Olokizumab 120 mg solution for injection, administered as subcutaneous injections
16191185|NCT01463059|Biological|Olokizumab 240 mg|Olokizumab 240 mg solution for injection, administered as subcutaneous injections
16191186|NCT01463046|Drug|Panobinostat|"Induction - 20-60 mg (1-3 20 mg capsules) PO on days 1,3,5 and 8
~Second induction - 20-60 mg (1-3 20 mg capsules) PO days 1,3 and 5
~Consolidation - 20-60 mg (1-3 20 mg capsules) PO on days 1,3,5 and 8"
16191187|NCT01463046|Drug|Cytarabine|"Induction - 100 mg/m2 continuous IV daily for 7 doses on day 3-9.
~Second induction - 100 mg/m2 continuous IV daily for 7 doses on day 3-7.
~Dosing for consolidation - 100 mg/m2 continuous IV daily for 7 doses on day 3-9."
16191188|NCT01463046|Drug|Daunorubicin|"Induction - 60 mg/m2 IV over 15-30 minutes daily for 3 doses on day 3-5.
~Second induction - 60 mg/m2 IV over 15-30 minutes daily for 2 doses on day 3 and 4.
~Dosing for consolidation - 60 mg/m2 IV over 15-30 minutes daily for 3 doses on day 3-5."
16191189|NCT01463033|Drug|Levetiracetam|55 mg/kg/day given in 2 divided doses 12 hours apart
16191190|NCT01463020|Behavioral|Smartphone delivered BA|A 8 week behavioural activation therapy delivered through smartphone
16191191|NCT01463020|Other|Smartphone delivered mindfulness|A 8 week mindfulness intervention delivered through smartphone
16191192|NCT01463007|Radiation|Accelerated partial breast irradiation|Accuboost APBI 34.0 Gy in 10 fractions
16191193|NCT01463007|Other|Extended Follow up|This arm extends follow up at the Rhode Island Hospital location to 5 years. Annual mammograms and additional documentation is required to be submitted only if completed.
16191194|NCT01462994|Other|Blood will be withdrawn at baseline and in intervals of 3 months for a total period of 2 years|
16191195|NCT01462968|Device|Activated clotting time versus blood-heparin concentration|Activated clotting time used for heparinization strategy during cardiag surgery versus blood-heparin concentration
16191196|NCT01462942|Drug|Aclidinium Bromide/Formoterol Fumarate|Inhaled Aclidinium/formoterol Fixed Dose Combination (FDC) low dose (400/6 μg), twice per day
16191197|NCT01462942|Drug|Aclidinium Bromide/Formoterol Fumarate|Inhaled Aclidinium/formoterol FDC high dose (400/12 μg), twice per day
16191198|NCT01462942|Drug|Aclidinium Bromide|Inhaled Aclidinium 400 μg, twice per day
16191199|NCT01462942|Drug|Placebo|Inhaled dose-matched placebo, twice per day
16191200|NCT01462942|Drug|Formoterol Fumarate|Inhaled Formoterol 12 μg, twice per day
16191201|NCT01462929|Drug|Aclidinium bromide|Dosage form: Dry powder. Route of administration: Oral inhalation by Genuair multidose dry powder inhaler Dose and regimen: 1 puff of 400 micrograms in the morning (09:00 ± 1h) and in the evening (21:00 ± 1h)
16191202|NCT01462929|Drug|Tiotropium|Dosage form: Dry powder hard gelatin capsule. Route of administration: Oral inhalation by HandiHaler single-dose dry powder inhaler Dose and regimen: 1 capsule (18 μg) in the morning (09:00 ± 1h)
16191203|NCT01462929|Drug|Placebo|Dosage form: Dry powder Route of administration: Oral inhalation by Genuair multidose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h) and 1 puff in the evening (21:00 ± 1h) AND Oral inhalation by HandiHaler single-dose dry powder inhaler. 1 puff of placebo in the morning (09:00 ± 1h).
16191242|NCT01462656|Drug|Non-EZG AED monotherapy|AED monotherapy without EZG
16191243|NCT01462656|Drug|EZG AED monotherapy|Any off-label use of EZG as monotherapy
16191204|NCT01462916|Dietary Supplement|honey|A crossover design (two 12-weeks intervention periods) will be used to measure treatment effects. The subjects will be randomized into two groups (intervention to control [I/C] and control to intervention [C/I] groups). Each study group will have 15 subjects. The subjects in the I/C group will consume 2 ml honey/kg/dose (maximum 50 ml/dose), twice weekly in the first 12-week period (period 1) while the subjects in the C/I group will not receive honey as a Control in period 1. After period 1 the subjects of each group will exchange their protocol for the following 12-week period (period 2).
16191205|NCT01462903|Biological|tumor infiltrating lymphocytes, IL-2|Biological: Infusion of Tumor Infiltrating Lymphocytes (10e9-10e10 cells) by iv in 30 Minutes. Followed by daily sc injections of 2 MIE Interleukin-2 for two weeks.
16191206|NCT01462890|Biological|Bevacizumab|15 mg/kg, iv on day 1 every 3 weeks up to and including cycle 22 vs cycle 44
16191207|NCT01462890|Drug|Paclitaxel|175 mg/m², iv on day 1 every 3 weeks for 6 cycles
16191208|NCT01462890|Drug|Carboplatin|AUC 5, iv on day 1 every 3 weeks for 6 cycles
16191209|NCT01462890|Other|specialized pathology review (Germany only)|before randomization
16191210|NCT01462877|Drug|fenofibrate|Fenofibrate Capsule 200mg qd orally
16191211|NCT01462864|Behavioral|Structured Lifestyle Education|A 3-4 hours group education delivered in a patient group composed of 4-8 patients and delivered by two healthcare professionals.
16191212|NCT01462851|Drug|PF-05297909 25 mg|Single oral (PO) dose, PF-05297909 25 mg
16191213|NCT01462851|Drug|PF-05297909 100 mg|Single oral (PO) dose, PF-05297909 100 mg
16191214|NCT01462851|Drug|PF-05297909 250 mg|Single oral (PO) dose, PF-05297909 250 mg
16191215|NCT01462851|Drug|PF-05297909 525 mg|Single oral (PO) dose, PF-05297909 525 mg
16191216|NCT01462851|Drug|PF-05297909 525 mg|Single oral (PO) dose, 525 mg
16191217|NCT01462838|Biological|P16_37-63|100 ug per application subcutaneously, mixed with 0.3 ml Montanide ISA-51 VG; once a week for four weeks, followed by a 4 week rest period (1 cycle), up to 3 cycles
16191218|NCT01462825|Dietary Supplement|tomato ketchup meal|A single intake of 200 g tomato ketchup together with 200 g white cooked rice.
16191219|NCT01462825|Dietary Supplement|Placebo meal|Self-prepared vinaigrette matching the qualitative and quantitative macronutrient composition of the tomato ketchup together with 200 g cooked rice resulting in a meal that is isocaloric to the tomato-ketchup meal
16191220|NCT01462812|Drug|Sumatriptan|Sumatriptan 20mg
16191221|NCT01462812|Drug|Placebo|Matching placebo
16191222|NCT01462799|Behavioral|PBL in patient education|The experiment group will enter a PBL patient education that is characterised by autonomous learning. The patients work together in small groups. Focus is on lifestyle changes. Starting point of learning is the patient's individual life style goals. Thirteen meetings during 1 year for 2 hours; weekly for the first month, every second week next two months and the last meetings 16, 20 and 26, 39 and 52 weeks after start. The programme shall be completed 1 year after start. The patients work with starting triggers such as pictures, texts, or concrete materials. Nurses work as tutors (after completion of a tutorial education) during the meetings using a problem based model to support patients formulate issues and goals to work with during the year. When the patients do not solve question the possibility of inviting e.g. a GP, dietician, pharmacist or physiotherapist is possible.
16191223|NCT01462799|Behavioral|Mailed patient information|During the study year patients in this control group will receive mailed patient information about life style changes.
16191224|NCT01462786|Drug|ATX-101|2 mg/cm2 ATX-101
16191225|NCT01462773|Drug|Bortezomib|VELCADE (1.0 mg/m2, 1.3 mg/m2, or 1.6 mg/m2 IV based on patient cohort). After three patients have received 5 weeks of therapy (1 cycle) at the initial dose of VELCADE (1.0 mg/m2, Cohort 1) with no dose limiting toxicity, the dose will be raised to 1.3 mg/m2 for the next cohort of three patients. If this dose level is well-tolerated in three consecutive patients, the dose of VELCADE will be raised to 1.6 mg/m2.
16191226|NCT01462773|Drug|Interferon Alfa-2b|I = IFN-α-2b (INTRON A): 5 million units (MU)/m2 SC. INTRON A (5MU/m2) will be administered subcutaneously on Days 1, 3 and 5 of Week 0. During Cycle I, INTRON A will be administered on Days 1, 3 and 5 of Weeks 1-3 of and on Days 1 and 3 of Week 4 to allow for surgical biopsy on Day 5. During Cycles II-V, IFN-α will be administered on Days 1, 3 and 5 of Weeks 1-4. To assess the toxicity profile of IFN-α-2b alone, no VELCADE will be administered during Week 0.
16191227|NCT01462760|Device|Assessment with inclinometer|joint assessment with inclinometer. The inclinometer used in this trial is Baseline® Bubble Inclinometer
16191228|NCT01462760|Device|Assessment with actigraph|joint assessment with actigraph The actigraph used in this trial is the Motion Pod. It's an analysis and reeducation systems by biofeedback. The manufacturer is Movea.
16191229|NCT01462747|Device|KULIST|Twice daily dosing for 8 weeks
16191230|NCT01462734|Procedure|human vitreous and blood serum sampling, PCR|1ml of human vitreous and 3ml of human blood serum
16191231|NCT01462721|Device|eSVS® Mesh|Patients with multi-vessel coronary artery disease who require saphenous vein graft (SVG) coronary artery bypass graft (CABG) surgery of the Right coronary Artery (RCA) and the Circumflex Artery (Cx) due to atherosclerotic coronary artery disease will serve as their own control. They will be randomized to either an SVG+eSVS Mesh to the RCA and an SVG to the Cx or an SVG to the RCA and an SVG+eSVS Mesh to the Cx.
16191232|NCT01462708|Drug|[18F]MK-9470|Subjects will be injected with 10 mCi, and not to exceed 11 mCi (not >10% of 10 mCi limit)of [18F]MK-9470, followed by PET imaging.
16191233|NCT01462695|Other|Diagnostic Laboratory Biomarker Analysis|Correlative studies
16191234|NCT01462695|Other|Pharmacological Study|Correlative studies
16191235|NCT01462695|Drug|Sunitinib Malate|Given PO
16191236|NCT01462669|Drug|50mg Ezogabine/retigabine|A single 50mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state
16191237|NCT01462669|Drug|100mg Ezogabine/retigabine|A single 100mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state
16191238|NCT01462669|Drug|200mg Ezogabine/retigabine|A single 200mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state
16191239|NCT01462669|Drug|400mg Ezogabine/retigabine|A single 400mg ezogabine/retigabine tablet will be administered orally with the subject in the fasted state
16191240|NCT01462656|Drug|Non-EZG containing AED polytherapy|AED polytherapy without EZG
16191241|NCT01462656|Drug|EZG containing AED polytherapy|AED polytherapy including EZG
16191247|NCT01462630|Procedure|positron emission tomography|Correlative studies
16191248|NCT01462630|Procedure|computed tomography|Correlative studies
16191249|NCT01462630|Radiation|fludeoxyglucose F 18|Correlative studies
16191250|NCT01462617|Drug|GSK2269557|Study Drug
16191251|NCT01462617|Drug|GSK2269557 matching placebo|Study Drug
16191252|NCT01462604|Other|non-drug intervention educational programme|educational programme
16191253|NCT01462591|Dietary Supplement|L-citrulline|2 weeks of L-citrulline supplementation (100mg/kg of body weight).
16191254|NCT01462578|Drug|Azacitidine|Azacytidine injection: 75 mg/m²/d, subcutaneous; initial minimum 6 cycles; another 6 or 12 cycles according to MRD niveau; maximum 24 cycles
16191255|NCT01462565|Drug|current marketed FLOLAN (epoprostenol sodium)|continuous intravenous infusion
16191256|NCT01462565|Drug|new thermo stable formulation of epoprostenol sodium|continuous intravenous infusion
16191257|NCT01462552|Drug|Lapatanib|Prescription of lapatinib (Tykerb)
16191258|NCT01462513|Biological|L-BLP25|Treatment: 930µg per treatment once weekly for 8 weeks, then at 6-week intervals during years 1 and 2.
16191259|NCT01462513|Biological|Placebo|Treatment: Placebo 930µg per treatment, once weekly for 8 weeks, then at 6-week intervals during years 1 and 2.
16191260|NCT01462500|Drug|Miltefosine|Children (2-12 years of age) and adults (18-60 years of age) will receive Miltefosine PO at a dose of 1.8-2.5 mg/kg/day for 28 days.
16191261|NCT01462487|Drug|Treatment with zanamivir|Subjects treated with zanamivir
16191262|NCT01462474|Drug|Famitinib|Either at 12.5 mg, 16.5 mg、20 mg or 25 mg qd p.o., 2 weeks before concurrent chemoradiotherapy and D1-D49, exception D1, D22, and D43.
16191263|NCT01462474|Drug|Cisplatin|100 mg/m2, D1, D22, and D43(q3w)
16191264|NCT01462474|Radiation|radiation（IMRT）|IMRT (Intensity-Modulated Radiation Therapy). Radiation is delivered to GTV at 70 Gy in 32-33 fractions, CTV1 at 60 Gy in 32-33 fractions and CTV2 at 54 Gy in 32-33 fractions
16191265|NCT01462448|Procedure|Blood Draw|Single blood draw of 30 ml
16191266|NCT01462435|Drug|Diclofenac Test (lower dose)|Capsules
16191267|NCT01462435|Drug|Diclofenac Test (upper dose)|Capsules
16191268|NCT01462435|Drug|Celecoxib|200 mg Capsules
16191269|NCT01462435|Drug|Placebo|Capsules
16191270|NCT01462422|Drug|Misoprostol|Selective administration of 800 mcg sublingual misoprostol to women with at least 350 mL blood loss within 1 hour following delivery
16191271|NCT01462422|Drug|Misoprostol|Universal administration of 600 mcg oral misoprostol given to all women within 5 minutes of delivery of the baby
16191272|NCT01462409|Device|RESMed S9 with humidifier H5i and heated tube Climate Line|At stable ambient room temperature and different CPAP pressure levels, 8 and 12 cmH2O, with and without additional leakage, humidity and temperature is measured inside of a patients nasal mask. Controlled heated humidification with heated tubing (Climate Line).
16191273|NCT01462409|Device|CPAP without humidification|At stable ambient room temperature and different CPAP pressure levels, 8 and 12 cmH2O, with and without additional leakage, humidity and temperature is measured inside of a patients nasal mask. Without any humidification.
16191274|NCT01462409|Device|CPAP with heated humidification|At stable ambient room temperature and different CPAP pressure levels, 8 and 12 cmH2O, with and without additional leakage, humidity and temperature is measured inside of a patients nasal mask. With controlled heated humidification and standard tubing.
16191275|NCT01462396|Device|CD34+ cells selected with the Miltenyi Clinimacs machine|Haploidentical allogeneic stem cell transplant following sub-myeloablative conditioning and cell selection using the Miltenyi Clinimacs device
16191276|NCT01462370|Drug|Etoricoxib|Etoricoxib 120 mg tablet given orally for one dose.
16191277|NCT01462370|Drug|Ibuprofen|Ibuprofen 600 mg (three 200-mg capsules) given orally up to four times a day as needed, for a maximum of 2400 mg/day.
16191278|NCT01462370|Drug|Placebo to etoricoxib|Placebo to etoricoxib, one tablet.
16191279|NCT01462370|Drug|Placebo to ibuprofen|Placebo to ibuprofen, up to four 3-capsule doses.
16191280|NCT01462370|Drug|Acetaminophen 250 mg, isopropylantipyrine 150 mg and anhydrous caffeine 50 mg|Provided to participants as rescue medication. Participants may take 2 tablets at a time and up to 3 doses within 24 hours for rescue purposes.
16191281|NCT01462357|Biological|Cervarix|2 doses of 0.5 mL supplied as a liquid in individual pre-filled syringes to be administered intramuscularly in the deltoid muscle of the non-dominant arm at Day 0 and Month 6.
16191282|NCT01462357|Biological|Gardasil|2 or 3 doses of 0.5 mL supplied as a liquid in individual pre-filled syringes or vials to be administered intramuscularly in the deltoid muscle of the non-dominant arm at Day 0 and Month 6 (Gardasil 2 dose Group) or at Day 0, Month 2 and Month 6 (Gardasil 3 dose Group), respectively.
16191283|NCT01462357|Drug|Placebo|2 doses of 0.5 mL supplied as a liquid in individual pre-filled syringes to be administered intramuscularly in the deltoid muscle of the non-dominant arm at Month 2 to maintain blinding.
16191284|NCT01462344|Drug|ADVAIR 100/50mcg|fluticasone propionate/salmeterol combination (100/50mcg) twice daily (AM and PM) for 6 months
16191285|NCT01462344|Drug|ADVAIR 250/50mcg|fluticasone propionate/salmeterol combination (250/50mcg) twice daily (AM and PM) for 6 months
16191286|NCT01462344|Drug|FLOVENT 100mcg|fluticasone propionate (100) twice daily (AM and PM) for 6 months
16191287|NCT01462344|Drug|FLOVENT 250mcg|fluticasone propionate (250mcg) twice daily (AM and PM) for 6 months
16191288|NCT01462331|Other|Isomaltooligosaccharide (digestion-resistant carbohydrates)|12g/dose; three times a day
16191289|NCT01462331|Other|Isomaltooligosaccharide (digestion-resistant carbohydrates)|18g/dose, three times a day
16191290|NCT01462331|Other|Sucrose|12g/dose, three times a day
16191291|NCT01462318|Drug|Midazolam|5 mg
16191292|NCT01462318|Other|Caffeine|200 mg
16191293|NCT01462318|Drug|S-warfarin|10 mg
16191294|NCT01462318|Other|Vitamin K|10 mg
16191295|NCT01462318|Drug|Omeprazole|40 mg
16191296|NCT01462318|Drug|Dextromethorphan|30 mg
16191297|NCT01462318|Biological|BIIB019 (Daclizumab)|150 mg in 1 ml PFS
16191298|NCT01462305|Device|goLITE|goLITE at 30 minutes per day, within 30 minutes of waking in the morning
16191299|NCT01462305|Device|Control|light therapy using 580nm LED source within 30 minutes of waking in the morning every day for 6 weeks
16191300|NCT01462292|Drug|GSK2402968 3mg/kg/week|Comparison of 2 doses of GSK2402968
16191301|NCT01462292|Drug|GSK2402968 6 mg/kg/week|Comparison of 2 doses of GSK2402968
16191302|NCT01462292|Drug|Placebo to match GSK2402968 3 mg/kg/week|Matched placebo
16191303|NCT01462292|Drug|Placebo to match GSK2402968 6 mg/kg/week|Matched Placebo
16191304|NCT01462279|Drug|Thiamine|200mg of intravenous thiamine in 50ml of D5W will be infused over 30 minutes once
16191305|NCT01462266|Drug|Sitagliptin|Sitagliptin 100 mg tablet once daily for 24 weeks
16191306|NCT01462266|Drug|Comparator: Placebo|Placebo to sitagliptin once daily for 24 weeks
16191307|NCT01462266|Biological|Insulin Glargine|Participants on insulin glargine or another insulin regimen for at least 10 weeks prior to screening will continue or switch to open-label insulin glargine once-daily in the evening for the duration of the study.
16191308|NCT01462266|Drug|Metformin|Participants on metformin oral tablet(s) at a dose of at least 1500 mg/day for at least 10 weeks prior to screening will continue receiving metformin at their current dose for the duration of the study.
16191309|NCT01462253|Drug|Clofarabine, Cyclophosphamide|The proposed treatment schedule consists of a combination of Clofarabine plus Cyclophosphamide administered over 5 consecutive days (Treatment scheme).
16191310|NCT01462240|Device|LPS Flex Porous Femoral Components|Porous femoral components in total knee arthroplasty
16191311|NCT01462227|Drug|Naltrexone High Dose|Naltrexone 100mg for two administrations.
16191312|NCT01462227|Drug|Naltrexone Low Dose|Naltrexone 50mg for two administrations.
16191313|NCT01462214|Drug|Everolimus|Patients will be treated with low-dose oral cyclophosphamide (8 different dose levels and schedules) in combination with fixed dose (10 mg) everolimus in patients with mRCC.
16191314|NCT01462201|Device|Non Invasive Ultrasound|Each treatment session is estimated to take approximately 60 minutes and will be performed on a bi-weekly basis.
16191315|NCT01462188|Procedure|Immediate stenting|Primary coronary stenting
16191316|NCT01462188|Procedure|Delayed stenting|Coronary stenting 3 to 7 days after having reopened the vessel in the acute phase
16191317|NCT01462175|Drug|RO5503781|
16191318|NCT01462162|Drug|Tocilizumab|
16191319|NCT01462149|Drug|Neoadjuvant chemotherapy|Docetaxel 75mg/m2BAS, q 3 weeks, 3 cycles
16191320|NCT01462149|Drug|Carboplatin|Carboplatin AUC 5, q 3 weeks, 3 cycles
16191321|NCT01462136|Drug|ACHN-490 Injection|7.5 mg/kg single dose administered intravenously over 30 minutes
16191322|NCT01462123|Other|endoscopic assessment of colonic polyps|
16191323|NCT01462110|Device|19416-154-1|0.15% ethyl lauroyl arginate HCl-containing mouthrinse
16191324|NCT01462110|Device|W002194-0221P|5% hydroalcohol mouthrinse
16191325|NCT01462097|Behavioral|Aerobic exercise training|12 months of aerobic exercise
16191326|NCT01462097|Behavioral|Health Education|12 months of health education sessions
16191327|NCT01462084|Device|Adaptive servo-ventilation (ASV)|Adaptive servo-ventilation (ASV) is a form of positive airway pressure (PAP) that is delivered based on the needs of the individual.
16191328|NCT01462084|Device|Bi-Level PAP|Bi-Level PAP delivers therapy at 2 pressures IPAP and EPAP that are fixed.
16191329|NCT01462058|Dietary Supplement|Vitamin D3|70µg Vitamin D3, daily, 12 weeks
16191330|NCT01462058|Drug|Placebo|Placebo, daily, 12 weeks
16191331|NCT01462045|Behavioral|Mindfulness-based exercise|8-week program of mindfulness-based stretching and breathing exercises
16191332|NCT01462032|Behavioral|Training Executive, Attention and Motor Skills (TEAMS)|Children will be taught games targeting these skills and parents will be encouraged to play these games with children at home
16191333|NCT01462032|Behavioral|Parent support and education|Parents will participate in groups designed to provide information about ADHD and support for working with their child.
16191334|NCT01462019|Device|Photobiomodulation|"the participants of this group will receive, in addition to guidance on the breast care and proper techniques for feeding, phototherapy applications through photobiomodulador a device developed specifically for the treatment of nipple injuries. The parameters for applications are: continuous mode of emission, power output 10 mW, wavelength infrared (scanning from 880 to 904 nm) fluence of 4 J / cm ² and total application time of 10 minutes.
~The application of the device will be three times per week on alternate days for seven consecutive weeks, totaling 21 sessions."
16191335|NCT01462006|Drug|sirolimus|randomized to drug or placebo, followed by washout, followed by crossover
16191336|NCT01462006|Other|Placebo|randomized to drug or placebo, followed by washout, followed by crossover
16191337|NCT01461993|Biological|rLP2086 and Gardasil|Gardasil vaccine and rLP2086 injection will be given to the subject concomitantly in Group 1 at Months 0, 2 and 6.
16191338|NCT01461993|Biological|rLP2086|Injections of rLP2086 and saline will be given to the subject concomitantly in Group 2 at Months 0, 2 and 6.
16191339|NCT01461993|Biological|Gardasil|Injections of saline and Gardasil vaccine will be given to the subject concomitantly in Group 3 at Months 0, 2 and 6.
16191340|NCT01461980|Biological|rLP2086 + MCV4 + Tdap|At visit 1, group 1 will receive MCV4 + Tdap vaccines concomitantly with an injection of rLP2086. At visits 3 and 5 (Months 2 and 6), group 1 will receive an injection of rLP2086.
16191341|NCT01461980|Biological|MCV4 + Tdap + saline|At visit 1, group 2 will receive MCV4 + Tdap vaccines concomitantly with an injection of saline. At visits 3 and 5 (months 2 and 6), this group will receive a saline injection only.
16191342|NCT01461980|Biological|rLP2086 + saline|At visit 1, group 3 will receive 2 injections of saline concomitantly with an injection of rLP2086. At visits 3 and 5 (Months 2 and 6), group 3 will receive an injection of rLP2086. Subjects randomized to this group will receive MCV4 and Tdap following their final visit blood draw (Visit 6).
16191343|NCT01461967|Drug|Placebo|Single ascending doses
16191344|NCT01461967|Drug|RO5508887|Single ascending doses
16191345|NCT01461967|Drug|RO5508887|Single doses
16191346|NCT01461954|Drug|FST-100|FST-100
16191347|NCT01461954|Drug|FST-100 Vehicle|FST-100 Vehicle
16191348|NCT01461941|Drug|E6005|0.0% E6005 ointment applied twice daily for 4 weeks (vehicle-controlled phase), and then, following 8-week is extension phase which all subjects receive 0.2% E6005 ointment twice daily. Subjects are randomized to either 0.2% E6005 ointment group or vehicle group at a ratio of 2:1.
16191422|NCT01461486|Device|Oral Appliance (BRD)|The device increases the volume of the airway by mandibular traction.
16191349|NCT01461941|Drug|E6005 ointment (vehicle)|0.2% E6005 ointment applied twice daily for 4 weeks (vehicle-controlled phase), and then, following 8-week is extension phase which all subjects receive 0.2% E6005 ointment twice daily. Subjects are randomized to either 0.2% E6005 ointment group or vehicle group at a ratio of 2:1.
16191350|NCT01461928|Drug|Chemotherapy (Induction Period)|Participants will receive standard combination chemotherapy every 3-4 weeks for 6 to 8 months. The chemotherapy regimen will be selected at Investigator's discretion, for individual participant. Study protocol does not enforce any particular chemotherapy regimen.
16191351|NCT01461928|Drug|Rituximab|Participants will receive rituximab according to the regimen specified in individual arm.
16191352|NCT01461915|Drug|Abraxane ( Nab-paclitaxel)|Nab-paclitaxel 125 mg/m2 administered IV over 30 minutes. Given weekly for 3 weeks followed by one week of rest.
16191353|NCT01461915|Drug|Abraxane ( Nab-paclitaxel)|Nab-paclitaxel 125 mg/m2 administered IV over 30 minutes. Nab-paclitaxel to be given weekly for 3 weeks followed by one week of rest.
16191354|NCT01461915|Drug|Gemcitabine|Gemcitabine at 1000 mg/m2 over 30 minutes to be administered after the completion of Abraxane administration. Gemcitabine will be given weekly for 3 weeks followed by one week of rest.
16191355|NCT01461915|Drug|Gemcitabine|Gemcitabine at 1000 mg/m2 administered IV over 30 minutes (after the nab-paclitaxel IV administration is complete). Gemcitabine to be administered weekly for 3 weeks followed by one week of rest.
16191356|NCT01461915|Drug|ODSH ( 2-O, 3-O Desulfated Heparin)|"ODSH IV bolus at 4 mg/kg to be administered in 5 minutes immediately after completion of gemcitabine administration.
~ODSH 48-h IV continuous infusion at 0.375 mg/kg/h should be started immediately after the ODSH IV bolus has been administered."
16191357|NCT01461915|Drug|ODSH ( 2-O, 3-O Desulfated Heparin)|"ODSH IV bolus at 4 mg/kg will be administered in 5 minutes immediately after completion of gemcitabine administration.
~ODSH 48-h IV continuous infusion at 0.375 mg/kg/h should be started immediately after the ODSH IV bolus has been administered."
16191358|NCT01461915|Drug|Abraxane ( nab-paclitaxel)|Nab-paclitaxel 125 mg/m2 administered IV over 30 minutes will be given weekly for 3 weeks followed by one week of rest.
16191359|NCT01461915|Drug|Gemcitabine|Gemcitabine to be administered IV at 1000 mg/m2 over 30 minutes given weekly for 3 weeks followed by one week of rest
16191360|NCT01461889|Other|Transfuse plasma to High INR target|Using a dosing algorithm we will bolus plasma to reach an INR target (2.5) while patient is actively bleeding or 48 hours whichever comes first
16191361|NCT01461889|Other|Transfuse plasma to Low INR target|Using a dosing algorithm we will bolus plasma to reach an INR target (1.8) while patient is actively bleeding or 48 hours whichever comes first
16191362|NCT01461876|Drug|antiretroviral therapy|Standard of care antiretroviral therapy
16191363|NCT01461863|Dietary Supplement|Porridge protein calorie supplement|250 gm of fortified flour to make porridge containing 1062 kcal and 42 gm protein
16191364|NCT01461863|Dietary Supplement|multivitamin|Standard multivitamin
16191365|NCT01461850|Drug|Neoadjuvant chemotherapy + Interval Debulking Surgery|Patients with suspected advanced ovarian cancer (FIGO stage IIIC) will undergo only to diagnostic laparoscopy. Omental cake, diaphragmatic or peritoneal extensive carcinomatosis, tumor diffusion to the small and large curvature of the stomach, large and/or small bowel mesentery disease, spleen and/or liver metastases will be investigated in order to obtain a laparoscopic score. After neoadjuvant chemotherapy interval debulking surgery will be performed: total hysterectomy, bilateral salpingo-oophorectomy, radical omentectomy, appendectomy, pelvic and paraaortic lymphadenectomy, eventual bowel resection, eventual bladder resection, eventual splenectomy, eventual parietal and diaphragmatic peritonectomy, eventual gastric resection, eventual hepatic resection, eventual pancreas resection, eventual cholecystectomy.
16191366|NCT01461850|Procedure|Primary Debulking Surgery + Adjuvant Chemotherapy|Patients with suspected advanced ovarian cancer (FIGO stage IIIC) will undergo to diagnostic laparoscopy. Omental cake, diaphragmatic or peritoneal extensive carcinomatosis, tumor diffusion to the small and large curvature of the stomach, large and/or small bowel mesentery disease, spleen and/or liver metastases will be investigated in order to obtain a laparoscopic score. Then, an attempt of laparotomic cytoreduction will be performed: total hysterectomy, bilateral salpingo-oophorectomy, radical omentectomy, appendectomy, pelvic and paraaortic lymphadenectomy, eventual bowel resection, eventual bladder resection, eventual splenectomy, eventual parietal and diaphragmatic peritonectomy, eventual gastric resection, eventual hepatic resection, eventual pancreas resection, eventual cholecystectomy.
16191367|NCT01461837|Drug|CD34 selected T-cell depleted allogeneic SCT|Hydroxyurea (60 mg/kg/day) and azathioprine (3 mg/kg/day) day -59 to day -11; fludarabine (30 mg/m2) Days -17, -16, -15, -14, -13; busulfan (3.2 mg/kg/day) Days -12, -11, -10, -9; thiotepa (10 mg/kg IV) day -8; cyclophosphamide (50 mg/kg) Days -7, -6, -5, -4; TLI on day -3; rabbit ATG (2.0 mg/kg/day) day -5,-4,-3, and -2; Stem Cell infusion day 0
16191368|NCT01461824|Drug|Depot medroxyprogesterone acetate (DMPA)|75mg, 104mg and 150mg DMPA, IM, every 12 weeks for 12 months
16191369|NCT01461811|Device|Nelfilcon A toric contact lenses (with comfort additives)|
16191370|NCT01461811|Device|Nelfilcon A toric contact lenses|
16191371|NCT01461798|Dietary Supplement|assessment of efficacy of Benecol yogurt|Benecol Yogurt and Yogurt placebo for 4 weeks each, at a dose of 100 ml (200 ml in total) of yogurt twice a day with main meals
16191372|NCT01461798|Dietary Supplement|Placebo Yogurt|Yogurt without the active principle
16191373|NCT01461798|Dietary Supplement|yogurt|yogurt without plant stanols
16191374|NCT01461785|Biological|Addition of PRP ( platelet rich plasma) to the lipograft|"27 ml blood will be drawn from the patient. The blood will be prepared according to the GPS System instructions (Biomet Biologics, LLC, Warsaw, Indiana USA). This desktop-size centrifuge has disposable cylinders to separate the different blood components (platelet rich plasma, PRP, platelet poor plasma, PPP, and red blood cells). The PRP is activated by adding calcium (15-volume % Ca2+ Sandoz®). creating activated Platelet Rich Plasma (aPRP).
~The lipograft of Group A will be enriched with 3ml of autologous PRP"
16191420|NCT01461499|Drug|any angiotensin receptor blockers|The patient will start taking one a standard dose of an ARB in Japan. In case blood pressure doesn't reach the target (SBP/DBP < 130/80 mmHg), higher dose of the ARB will be given. In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (DRI, another ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.
16191421|NCT01461486|Device|Continuous Positive Airway Pressure (CPAP)|The device is a flow generator used to open the airway during sleep.
16191375|NCT01461785|Procedure|Lipofilling of the midface|The Coleman technique for fat harvesting and injection is employed but refined by utilizing a smaller, custom-made cannula for harvesting (inner diameter, 1.3 mm). The abdomen and upper legs are donor sites. Approximately two to three times more fat is harvested than the estimated amount required for the procedure. Fat is centrifuged for three minutes at the maximum speed of 3000 revolutions per minute after which the oil layer (top) and serum/infiltrate layer (bottom) are drained away, preserving the preadipocyte-rich pellet. Fat injection is performed in 1-mm aliquots with a short, curved Coleman cannula. Between 13 and 23 mL of fat is injected into the deep subcutaneous plane of each side of the face, except for the lower lid/tear trough region (where the injection is performed in the supraperiosteal/submuscular plane) and the temporal area (where the level of injection was above the superficial fascia of the temporal muscle).
16191376|NCT01461772|Radiation|Radiation therapy|pelvic radiation therapy (Extended filed radiation therapy and addition of brachytherapy is allowed)
16191377|NCT01461772|Drug|Carboplatin|carboplatin 130mg/m2BSA on day 1,8,15,22,29,and 36
16191378|NCT01461772|Drug|Cisplatin|Cisplatin 40mg/m2BSA on day 1,8,15,22,29,and 36
16191379|NCT01461759|Drug|Doctaxel|Docetaxel 70mg/m2BSA, q 3 weeks, 8 cycles
16191380|NCT01461759|Drug|Cisplatin|Cisplatin 60mg/m2BAS, q 3 weeks, 8 cycles
16191381|NCT01461746|Drug|Docetaxel|Docetaxel 70mg/m2BSA, q 3 weeks, 3 cycles
16191382|NCT01461746|Drug|Cisplatin|Cisplatin 60mg/m2BSA, q 3 weeks, 3 cycles
16191383|NCT01461746|Radiation|Radiation therapy|Pelvic radiation therapy (Extended filed radiation therapy and addition of brachytherapy is allowed)
16191384|NCT01461733|Drug|amiodarone|standard dose amiodarone
16191385|NCT01461733|Drug|Placebo|placebo delivered blinded
16191386|NCT01461720|Other|Standard medical care|Standard medical care includes treatment to prevent recurrence, optimal control of risk factors and post stroke follow-up rehabilitative treatment.
16191387|NCT01461720|Biological|Autologous bone marrow-derived mesenchymal stem cells|Single intravenous infusion of autologous bone marrow-derived mesenchymal stem cells concurrently with standard medical care.
16191388|NCT01461707|Behavioral|Mobile phone-based physical activity|Participants will receive the mobile phone-based physical activity program using the trial app.
16191389|NCT01461707|Behavioral|Activity monitor|Participants will receive an activity monitor
16191390|NCT01461694|Device|Intense Pulsed Light (IPL)|Half Face Treated with IPL
16191391|NCT01461694|Device|Alexandrite Laser|Half face treated with Alexandrite Laser
16191392|NCT01461681|Procedure|Symptom Management Service for Heart failure|The symptom management service for heart failure (SMS-HF) will begin in the hospital where the patient will be seen daily until discharge and continue with at least 6 contacts over the next 6 months with the first outpatient contact occurring in person in the HF clinic within a month of discharge. Of the subsequent 5 monthly contacts, at least 2 will be in person with the remainder by telephone. Additional contacts between the SMS-HF team and patient will be scheduled as needed. Patients discharged to a site other than home will have monthly contacts by telephone until they are able to attend the clinic. We will assess changes in depression, pain, dyspnea, and quality of life from baseline to 6 month follow-up.
16191393|NCT01461668|Drug|Retapamulin|Two times a day for 5 days
16191394|NCT01461668|Drug|Placebo|Two times a day for 5 days
16191395|NCT01461655|Drug|marketed topical retinoid|once daily application, 4 weeks
16191396|NCT01461655|Drug|marketed topical NSAID|once daily application, 4 weeks
16191397|NCT01461655|Drug|vehicle gel|once daily application, 4 weeks
16191398|NCT01461655|Drug|marketed topical retinoid|once daily application, 4 weeks
16191399|NCT01461642|Other|Self management asthma plan indorsment.|Subjects adherence to asthma self management plan will be monitored through web-based support.
16191400|NCT01461616|Drug|NPH|equal doses of NPH insulin, insulin Detemir and insulin glargine injection
16191401|NCT01461616|Drug|Detemir|equal doses of NPH insulin, insulin Detemir and insulin glargine injection
16191402|NCT01461616|Drug|Glargine|equal doses of NPH insulin, insulin Detemir and insulin glargine injection
16191403|NCT01461603|Dietary Supplement|Vamin (Fresenius Kabi)|Vamin 18gN 1ml/min infusion in 6 hours
16191404|NCT01461603|Dietary Supplement|3hydroxybutyrate|Goldbio, FFA-3OHB, dry powder mixed with sterile water at Aarhus University hospital pharmacy.
16191405|NCT01461590|Other|Whole blood|30mls/kg transfused over fours hours
16191406|NCT01461590|Other|Whole blood|20mls/kg transfused over four hours
16191407|NCT01461577|Drug|INSULIN GLARGINE HOE 901|Pharmaceutical form:solution Route of administration: subcutaneous
16191408|NCT01461564|Procedure|Colonoscopy|Screening colonoscopy
16191409|NCT01461551|Drug|Sevoflurane|anesthesia was maintained with sevoflurane (end-tidal concentration 1.0-1.5 minimum alveolar concentration)
16191410|NCT01461551|Drug|Propofol|anesthesia was maintained with propofol (2-4 μg/ml via target-controlled infusion)
16191411|NCT01461551|Drug|combine of sevoflurane and propofol|anesthesia was maintained with a combine of propofol (1 μg/ml via target-controlled infusion) and sevoflurane (end-tidal concentration 0.7-1.0 minimum alveolar concentration)
16191412|NCT01461538|Drug|brentuximab vedotin|1.8 mg/kg every 3 weeks by intravenous (IV) infusion
16191413|NCT01461538|Drug|brentuximab vedotin|2.4 mg/kg every 3 weeks by intravenous (IV) infusion
16191414|NCT01461538|Drug|brentuximab vedotin|1.2 mg/kg weekly, 3 out of 4 weeks, by intravenous (IV) infusion
16191415|NCT01461525|Procedure|Abdominoperineal resection|After high ligation of IMA, TME with autonomic nerve preservation, proctectomy with sphincter sacrifice and permanent colostomy.
16191416|NCT01461525|Procedure|Sphincter preservation surgery|After high ligation of IMA, TME with autonomic nerve preservation, sphincter preservation and proctectomy with distal margin of more than 0.5cm in length and temporary ileostomy
16191417|NCT01461512|Drug|heme arginate administration|heme arginate 1 mg/kg body weight 24 hours prior to ischemia
16191418|NCT01461512|Drug|Placebo administration|NaCl isotonic
16191419|NCT01461499|Drug|Aliskiren|The patient will start taking one a daily 150 mg/day of aliskiren. In case blood pressure doesn't reach the target (SBP/DBP < 130/80 mmHg), higher dose of aliskiren will be given.In case the blood pressure doesn't achieve the target, another anti-hypertensive drug other than RAS inhibitors (ARB or ACE-inhibitor) or potassium-retaining diuretics will be added from the minimum effective dose.
16191423|NCT01461473|Device|Positive Airway Pressure (PAP)|Participants randomized to the Positive Airway Pressure treatment group received adequate Positive Airway Pressure (PAP) pressure therapy by a PAP titration study and used the device for 6 months.
16191424|NCT01461473|Device|Oral Appliance (OA)|Participants randomized to the Oral Appliance treatment group received a dental evaluation to determine the optimal setting for the Oral Appliance (OA), and used the appliance for 6 months.
16191425|NCT01461460|Drug|TR-701 FA 1200 mg|6 tablet of T-701 FA
16191426|NCT01461460|Drug|Moxifloxacin 400 mg|1 tablet 400 mg Moxifloxacin
16191427|NCT01461460|Drug|TR-701 FA 200 mg plus Placebo|1 tablet of TR-701 FA with 5 tablet placebo
16191428|NCT01461460|Drug|Placebo|6 placebo tablets
16191429|NCT01461447|Biological|Modified Vaccinia Ankara|Healthy volunteers will receive intramuscularly 1 injection of MVA-CMDR 1ml (Total 10 power 8 pfu) boost injection in the left deltoid muscle.
16191430|NCT01461434|Device|Medtronic Reveal XT implantable loop recorder|subcutaneous implantation
16191431|NCT01461421|Behavioral|Nutrition Education|Participants are taught about energy balance, caloric intake, the nutrition content of foods, and diet.
16191432|NCT01461421|Behavioral|Behavioral Weight Loss Strategies|Participants are taught self-monitoring and goal setting techniques.
16191433|NCT01461421|Behavioral|Standard Cognitive Techniques|Participants are taught how to modify, get rid of, or distract from thoughts and also how to regulate emotions.
16191434|NCT01461421|Behavioral|Acceptance Based Techniques|Participants are taught how to accept and change their perception of their thoughts and emotions.
16191435|NCT01461408|Behavioral|Health Education Session|"The educational messages during the education session will engage individual women, their peer group, their family members and community influencers in a way that is authentic and share-able. Involving women in give-and-take discussions with people they trust and respect-their hairdressers-will be essential to increasing the number of them who consider the HPV vaccine for themselves and for those they care about.
~The investigators plan to recruit eight (8) predominantly African American beauty salons in Philadelphia and train multiple stylists in each salon to act as in-salon educators and facilitators for client recruitment to sexual health education sessions. These education sessions will be run by trained health educators (also African American females) and take place during down times in each of the salons, on a rotating basis. There will be two types of sessions offered, one for mothers of females ages 9-18 and one for females ages 18-26."
16191436|NCT01461382|Other|Treadmill Desks|Treadmill Desk were installed in subjects personal workspace.
16191437|NCT01461382|Other|Treadmill Desks|Treadmill desks were installed in subjects personal workspace six months after phase I started.
16191438|NCT01461369|Drug|Diclofenac|35 mg bid Capsules
16191439|NCT01461369|Drug|Diclofenac|35 mg tid Capsules
16191440|NCT01461369|Drug|Placebo|Capsules
16191441|NCT01461356|Procedure|Minimally invasive total knee replacement|A cemented tricompartmental total knee replacement will be performed using a minimally invasive surgical approach.
16191442|NCT01461356|Procedure|Standard approach total knee replacement|A cemented tricompartmental total knee replacement will be performed using a traditional medial parapatellar surgical approach.
16191443|NCT01461343|Other|CT imaging, functional PET imaging|Physiology study using CT and functional PET imaging with 13NN and 11CO as radiotracers; images obtained before and after administration of inhaled nitric oxide and balance 80% oxygen as pulmonary vasodilators
16191444|NCT01461330|Other|DASH diet plus exercise|"DASH diet adapted to the usual diet of Brazilian type 2 diabetic patients = prescription of a normocaloric diet including fruits, vegetables, grain products, low fat dairy foods, legumes, without sugar, and with limited fat
~Exercises: the recommended physical activity will consist of using a pedometer during the experimental period."
16191445|NCT01461330|Other|ADA diet|Adoption of ADA diet.
16191446|NCT01461317|Drug|Etrolizumab|Participants will receive etrolizumab at a dose of 100 mg.
16191447|NCT01461304|Drug|triheptanoin|subjects will receive a modified diet containing triheptanoin (up to 2 grams/kg/24 hours; subjects who experience cardiomyopathy may receive doses up to 4 grams/kg/24 hours), or continued on their previously established triheptanoin dose; not to exceed RDA for fat, substituted for their MCT oil and/or natural fat. Study subjects will continue the triheptanoin-supplemented diet for a period of 12 months and then be able to continue into an indefinite extension phase in this compassionate use study. Laboratory evaluations will take place at two, six, and twelve months as well as every 12 months in the extension phase.
16191448|NCT01461291|Device|iStent inject|Implantation of two GTS400 stents using G2-M-IS iStent inject
16191449|NCT01461291|Procedure|Cataract surgery|Cataract surgery alone
16191450|NCT01461278|Device|iStent supra|Cataract surgery and implantation of one iStent supra
16191451|NCT01461278|Procedure|Cataract surgery|Cataract surgery alone
16191452|NCT01461265|Procedure|Cryoablation|For cryoablation in the palliation of painful bone metastases, subject preparation, anesthesia, intra-operative monitoring, and postoperative management are identical to those of standard cryoablation routinely performed at all clinical centers participating in this study and are at the discretion of the investigator.
16191453|NCT01461252|Procedure|Cryoablation|For cryoablation in the palliation of painful bone metastases, subject preparation, anesthesia, intra-operative monitoring, and postoperative management are identical to those of standard cryoablation routinely performed at all clinical centers participating in this study and are at the discretion of the investigator.
16191454|NCT01461252|Procedure|Radiation|Radiation therapy is usually performed with 6-18 Megavolt photons from a linear accelerator. The proposed dose and frequency of radiation for this protocol are: 8 Gray in 1 fraction, 30 Gray in 10 fractions, or 37.5 Gray in 15 fractions. These proposed doses or other doses will be prescribed at the discretion of the investigator. It is anticipated that subjects will begin the radiation therapy approximately within one to three weeks after the cryoablation procedure. The doses and frequency of the radiation treatment will be collected as well as toxicities.
16191455|NCT01461239|Procedure|fiber post and resin core - self-adhesive cement|pre-fabricated glass fiber posts, cemented with self-adhesive resinous cement
16191456|NCT01461239|Procedure|cast post and core|Ni-Cr alloy cast post and core luted with self-adhesive resin cement
16191457|NCT01461239|Procedure|fiber post luted with conventional resin cement|fiber post luted with conventional etch-and-rinse adhesive system and conventional resin cement, followed by core construction with composite resin
16191458|NCT01461226|Behavioral|Exercise training|Individualized and progressively increased supervised aerobic exercise program on a daily base (3-4hours per day, hypocaloric diet and psychological guidance
16191459|NCT01461226|Behavioral|Usual care|Nutritional assessment and dietary advice by general practitioner, promotion of sports activities
16191460|NCT01461213|Drug|rAAV2.REP1|Single subretinal injection of rAAV2.REP1 vector suspension containing 10e12 genome particles per ml. Dose 1 = dose containing approximately 10e10 rAAV2.REP1 genome particles. Dose 2 = dose containing approximately 10e11 rAAV2.REP1 genome particles.
16191461|NCT01461200|Other|Swab of vestibule and middle meatus of nose|Swabs of vestibule and middle meatus of nose will be taken prior to and during the grass/tree allergy season
16191462|NCT01461187|Other|exercise during pregnancy|supervised aerobic physical exercises twice a week.
16191463|NCT01461174|Drug|Modafinil|200 mg tablet, single dose
16191464|NCT01461174|Drug|Donepezil|Donepezil or placebo, 5 mg tablet one per day, 15 days
16191465|NCT01461174|Drug|Memantine|Memantine or placebo, 10 mg tablet one per day, 15 days
16191466|NCT01461161|Drug|bardoxolone methyl|oral, single dose
16191467|NCT01461148|Biological|FSP peptides|100 ug of each FSP (TAF1B(-1), HT001(-1) and AIM2(-1), weekly for 4 consecutive weeks and repeated every four weeks up to a total of 3 cycles.
16191468|NCT01461109|Drug|[18F] CFPyPB|Each subject will receive a bolus injection targeted to be 5 mCi and not to exceed 5.5 mCi (not >10% of 5 mCi limit) of [18F]CFPyPB or 5 μg of CFPyPB (whichever is greatest).
16191469|NCT01461096|Biological|Quadrivalent HPV Vaccine|Participants were prescribed one intramuscular (IM) injection of the quadrivalent HPV vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.
16191470|NCT01461096|Biological|Placebo Vaccine for Male Participants Only|Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.
16191471|NCT01461096|Biological|Placebo Vaccine for Female Participants Only|Participants were prescribed one IM injection of the placebo vaccine in the upper arm or thigh at baseline and Weeks 8 and 24.
16191472|NCT01461083|Drug|[18F]MPPF|Subjects will be dosed by intravenous bolus injection of [18F]MPPF targeted to be 5.0 mCi, and not to exceed 5.5 mCi (not >10% of 5.0 mCi limit) and not to exceed 5 µg of MPPF
16191473|NCT01461057|Drug|Capecitabine|1000 mg/m2 twice daily, from the evening of Day 1 to the morning of Day 15 of each cycle
16191474|NCT01461057|Drug|Cisplatin|80 mg/m2 on Day 1 of each cycle
16191475|NCT01461057|Drug|Pertuzumab|loading dose of 840 mg, then 420 mg once every three weeks
16191476|NCT01461057|Drug|Pertuzumab|840 mg once every three weeks
16191477|NCT01461057|Drug|Trastuzumab|loading dose of 8 mg/kg for Cycle 1 and a dose of 6 mg/kg for subsequent cycles
16191478|NCT01461031|Drug|nefopam|nefopam infusion for postoperative 24 hours
16191479|NCT01461031|Drug|normal saline (control)|normal saline infusion for postoperative 24 hours
16191480|NCT01461018|Biological|Immune globulin subcutaneous (Human)|IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use.
16191481|NCT01461005|Device|Dynamic Stabilization System (DSS)|Dynamic Stabilization System
16191482|NCT01460992|Procedure|Evia/Entovis pacemaker system under Magnetic Resonance Imaging (MRI) conditions|patients will undergo an MRI scan for 30 minutes.
16191483|NCT01460979|Drug|Temsirolimus|25mg weekly intravenous until progression
16191484|NCT01460966|Procedure|Filtrap™ + Thrombus aspiration catheter|Combination of distal protection device (Filtrap™ )and thrombus aspiration catheter
16191485|NCT01460966|Procedure|Thrombus aspiration catheter|Thrombus aspiration catheter only
16191486|NCT01460953|Behavioral|health literacy training video|participants will watch a training video
16191487|NCT01460940|Drug|panobinostat|Administered orally Monday, Wednesday, Friday of every week for 4 weeks. A cycle is define as 28 days.
16191488|NCT01460940|Drug|lenalidomide|Lenalidomide will be administered orally daily on days 1-21. Lenalidomide will not be given on days 22-28. A cycle is define as 28 days.
16191489|NCT01460927|Device|TriActive+ RF|"Radio frequency handpiece uses a multi-polar technology with a particular electrical frequency of 1MHz. The handpiece has a special skin contact identification system which delivers energy only when electrodes are adherent to the skin surface in order to avoid the prickling sensation when the treatment starts."
16191490|NCT01460901|Biological|GD2 CAR modified Tri-virus specific cytotoxic t-cells|This is a feasibility study to assess safety of an infusion of chimeric-antigen receptor gene modified allogeneic virus specific T lymphocytes after reduced intensity allogeneic stem cell transplant. Three patients were treated and safety was evaluated. Patients received a single infusion of 2x10e6/m2 donor derived, GD2 CAR modified, tri-virus specific CTL performed 30-120 days after allogeneic stem cell transplantation
16191491|NCT01460888|Drug|Olaparib|25mg tablets, oral. Commenced 3 days prior to radiotherapy and continuing until the last day of radiotherapy (36 days in total).
16191492|NCT01460888|Radiation|Radical external beam radiotherapy, 50Gy in 25 fractions|Radiotherapy to the oesophageal carcinoma. For patients receiving olaparib this is delivered as 50Gy in 25 daily fractions for 5 weeks (Monday-Friday only). For patients in the comparator arm (RT only) other total doses/ fractionation are permitted, according to local policy/ best standard care.
16191493|NCT01460875|Biological|recombinant interferon alfa-2b|Given SC
16191494|NCT01460875|Other|laboratory biomarker analysis|Blood for use in correlative studies approximately 30 ml 30 x 106 peripheral blood mononuclear cell (PBMCs) will be drawn on day 1 every other week during the first 12 weeks just prior to treatment and at 1 and 4 hours post therapy.
16191495|NCT01460836|Drug|Tobramycin solution for inhalation|
16191496|NCT01460836|Drug|Aztreonam lysine for inhalation|
16191497|NCT01460823|Procedure|Percutaneous Cochlear Implantation using image guided surgical techniques|Percutaneous Cochlear Implantation using image guided surgical techniques.
16191498|NCT01460810|Other|1000CsK Silicon Oil Tamponade|Details covered in arm description
16191499|NCT01460797|Other|Glycemic Index Diets and Metformin hydrochloride|1g of Metformin hydrochloride a day in High Glycemic Index Diet
16191500|NCT01460771|Device|TDCS (Transcranial Direct-current Stimulation)|active TDCS
16191501|NCT01460771|Device|sham TDCS (Transcranial Direct-current Stimulation)|TDCS at 0mA
16191541|NCT01460420|Drug|Bz (Bortezomib)|Bz 1.3 mg/m2 on days +1, +4 and +7. Maintenance therapy and dose reduction pre-specified.
16191502|NCT01460758|Device|Medial Frontal rTMS Double-Cone-Coil|High frequency rTMS ( Alpine Biomed Mag Pro Option) applied over medial superior frontal cortex (supplementary motor cortex) (Brodmann area 6/8),Double-Cone-water-cooled-Coil (2000 Stimuli of 10 Hz each session), 110% motor threshold.
16191503|NCT01460758|Device|Left DLPFC Butterfly Coil|High frequency rTMS ( Alpine Biomed Mag Pro Option): 2000 stimuli of 10 Hz over the left DLPFC (each session), Butterfly-water-cooled-Coil, 110% motor threshold.
16191504|NCT01460758|Device|Placebo Stimulation|Sham Stimulation (conventional butterfly-coil, angled 45°): left DLPFC continuous rTMS, 10 Hz, 2000 Stimuli each session, 110% motor threshold
16191505|NCT01460732|Device|Blood Pressure Monitoring|Home Blood pressure Monitoring Nocturnal-Home Blood Pressure Monitoring Ambulatory Blood Pressure Monitoring
16191506|NCT01460719|Biological|V212|V212 viral antigen for HZ
16191507|NCT01460706|Drug|[68Ga]DOTATOC|120MBq 68Ga-DOTATOC intravenously and PET/CT imaging. Performed once to a patient before the surgery.
16191508|NCT01460693|Drug|Imatinib|Oral Imatinib 100mg daily
16191509|NCT01460693|Drug|Dasatinib|Oral Dasatinib 100mg daily
16191510|NCT01460667|Drug|IV acetaminophen|IV acetaminophen 1000 mg (100 mL) every 6 hours over 30 hours
16191511|NCT01460667|Drug|IV normal saline|0.9% normal saline IV, every 6 hours over 30 hours.
16191512|NCT01460654|Drug|Testosterone|Testosterone Gel (Fortesta) 40mg daily.
16191513|NCT01460654|Drug|Alendronate|Alendronate (Fosamax) 70mg every week.
16191514|NCT01460654|Drug|Placebo Alendronate|A placebo alendronate tablet will be taken every week by subjects in the Testosterone and Placebo Alendronate Group.
16191515|NCT01460654|Drug|Placebo Testosterone|Placebo testosterone gel will be applied daily by subjects in the Alendronate and Placebo Testosterone group.
16191516|NCT01460628|Drug|Armodafinil|Women who are eligible will receive 4 weeks of treatment with armodafinil. Armodafinil will be titrated from 50-mg/day up to 150-mg/day. For exploratory reasons only, at the end of the 4-week treatment period, participants will enter a discontinuation phase in which they will be randomized to double-blind treatment with armodafinil 150-mg/day or matching placebo for 2 weeks in a 1-to-1 ratio. No primary outcomes were studied in the discontinuation phase.
16191517|NCT01460615|Drug|Hydrocortisone|
16191518|NCT01460602|Drug|MTD of Velcade, Nipent and Rituxan established in Part 1|"One of the following dose levels will be chosen and used in Part 2:
~(VAN1) VA= 1.3 mg/m2 IV Days 1, 4, 8, 11 N1= 2 mg/mg2 IV Days 1, 8 375 mg/m2 IV Day 1
~(VAN2) VA= 1.3 mg/m2 IV Days 1, 4, 8, 11 N1= 4 mg/mg2 IV Days 1, 8 375 mg/m2 IV Day 1
~(VBN1) VA= 1.5 mg/m2 IV Days 1, 4, 8, 11 N1= 2 mg/mg2 IV Days 1, 8 375 mg/m2 IV Day 1
~(VBN2) VA= 1.5 mg/m2 IV Days 1, 4, 8, 11 N1= 4 mg/mg2 IV Days 1, 8 375 mg/m2 IV Day 1"
16191519|NCT01460589|Procedure|timing to initiate the adjuvant chemotherapy|Chemotherapy regimen: FOLFOX-6, every 2weeks, total 12 cycles treatment day1: Oxaliplatin 85mg/m2 day1: Leucovorin 200mg/m2 day1: 5-FU 400mg/m2 IV bolus and 2,400mg/m2 over 46 hours
16191520|NCT01460563|Drug|Magnesium Sulfate|MgSO4 infusion: 50mg/kg bolus followed by continuous infusion
16191521|NCT01460563|Drug|0.9% saline|0.9% saline as same dose as MgSO4 as placebo
16191522|NCT01460563|Drug|0.9% saline|0.9% saline as same dose as MgSO4 as placebo
16191523|NCT01460550|Procedure|Retrocolic gastro- or duodeno- jejunostomy in hte pancreaticoduodenectomy|The duodenojejunostomy or gastrojejunostomy was constructed in two layers or single layer. For the retrocolic reconstruction, the jejunal loop was anastomosed to the duodenum or stomach through a separate mesocolic window on the left of the middle colic vessels.
16191524|NCT01460550|Procedure|Antecolic gastro- or duodeno- jejunostomy in the pancreaticoduodenectomy|The duodenojejunostomy or gastrojejunostomy was constructed in two layers or single layer. For the antecolic reconstruction, the jejunal loop about 30 cm distal to the hepaticojejunostomy, was brought up anterior to the transverse colon and anastomosed to the duodenum or stomach.
16191525|NCT01460537|Drug|Gemcitabine|Gemcitabine 1000mg/m2 as 30-minutes IV infusion
16191526|NCT01460537|Drug|BAY80-6946|Escalated dose starting from 0.6 mg/kg in 100 mL of 0.9% NaCl as 60-minutes IV infusion
16191527|NCT01460537|Drug|Cisplatin|1 liter of 0.9% NaCl including 25 mg/m2 cisplatin, 20 mmol of potassium chloride, and 8 nmol of magnesium sulfate over 60 minutes
16191528|NCT01460537|Drug|NaCl|Infusion of 500 ml of 0.9% NaCl over 30-minutes
16191529|NCT01460537|Drug|BAY80-6964 fixed dose|BAY80-6946 IV infusion at the maximum tolerated dose determined in Treatment A over 60 min. [If Treatment A MTD is not tolerable, further subject enrollment will begin at one BAY80-6946 Dose Level lower with the cisplatin-gemcitabine doses remaining constant.]
16191530|NCT01460511|Drug|E004 (Epinephrine Inhalation Aerosol) HFA-MDI|E004 (Epinephrine Inhalation Aerosol) HFA-MDI, 125 mcg/inhalation, 2 inhalations QID
16191531|NCT01460511|Drug|Placebo-HFA|Placebo-HFA, 0 mcg/inhalation, 2 inhalations QID
16191532|NCT01460498|Drug|Azacitidine (AZA)|Starting Dose 50 mg/m2 by subcutaneous or by vein for 3 days of a 28 day cycle.
16191533|NCT01460498|Drug|Tyrosine kinase inhibitor (TKI)|Continuation of dose already receiving during previous 6 months.
16191534|NCT01460498|Drug|Azacitidine|75 mg/m2 daily for 3 days, unless MTD defined at lower dose level in Phase I then that would become dose used for Phase II.
16191535|NCT01460472|Biological|Racotumomab|Patients will receive best support treatment and vaccination with racotumomab. The vaccination schedule is as follows: 5 doses (1mg/mL each), intradermally, every 2 weeks (induction period) followed by monthly vaccinations until any criteria for discontinuation are met. If disease progression occurs and further onco-specific therapy is indicated, the patient will be able to continue in the study and vaccination will not be interrupted unless criteria for vaccine discontinuation are met.
16191536|NCT01460472|Other|Best Support Treatment|Patients will receive best support treatment for advanced NSCLC as per each institution's standards, including onco-specific therapies when disease progresses.
16191537|NCT01460459|Behavioral|a specific frequency of SMBG|"Patients are instructed to measure their blood glucose concentrations 4 times per day (pre-prandial and before bedtime:
~high frequency: one day weekly middle frequency:one day per two weeks low frequency:one day monthly"
16191538|NCT01460446|Device|Aviva Expert blood glucose meter|
16191539|NCT01460446|Device|Aviva Nano blood glucose meter|
16191540|NCT01460433|Procedure|Genital and rectal swabbing|Subjects swabs their genitals and rectum daily. The amount of HSV shed over the previous 24 hours is measured and the daily HSV shed rate is calculated.
16195716|NCT01428622|Drug|BI54903|ethanolic solution
16191542|NCT01460420|Drug|Len (lenalidomide)|"Len at a dose of 6 mg po on day -5 and then 4 mg per day in order to maintain serum levels in the range of 6-12 ng /mL.
~Maintenance therapy and dose reduction pre-specified."
16191543|NCT01460407|Drug|LY2216684|Administered orally
16191544|NCT01460407|Drug|Clarithromycin|Administered orally
16191545|NCT01460381|Drug|LY2216684|
16191546|NCT01460381|Drug|Quinidine|
16191547|NCT01460368|Drug|LY2409021|Administered orally
16191548|NCT01460368|Drug|Placebo|Administered orally
16191549|NCT01460368|Drug|Moxifloxacin|Administered orally
16191550|NCT01460355|Drug|Botulinum Toxin Type A|injection of 5U in 0.1ml of saline solution will be given to the recessed muscle
16191551|NCT01460355|Drug|saline solution|injection of 0,1ml of saline solution will be given to the recessed muscle
16191552|NCT01460342|Drug|Tadalafil|5 mg (2 x 2.5-mg tablets), given once daily as oral tablet
16191553|NCT01460342|Drug|Placebo|2 tablets (identical to 2.5-mg tadalafil tablets) given orally once daily.
16191554|NCT01460329|Device|Ultrasonic Cardiac Output Monitor (USCOM).|This device is FDA approved and based on the principles of ECHO using continuous-wave Doppler ultrasound to measure cardiac output.
16191555|NCT01460316|Biological|Bood sampling for biochemicals and genetic analysis|There will be one blood sampling for the nutritionnal, metabolic and genetic parameters studied in the protocol
16191556|NCT01460303|Device|Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag|"OPTION-vf patient controlled catheter (transurethral catheter with external drainage valve to provide on-demand drainage of urine stored directly from the bladder), worn maximum of 30 days post-op until bladder challenge is passed. Bladder challenge is considered passed when a patient is able to void adequately and spontaneously (without the assistance of a catheter)."
16191557|NCT01460303|Device|Transurethral catheter with leg bag|"Transurethral catheter w/leg bag urine storage, worn maximum of 30 days post-up until bladder challenge is passed. Bladder challenge is considered passed when a patient is able to void adequately and spontaneously (without the assistance of a catheter)."
16191558|NCT01460290|Drug|Asenapine|Asenapine will be administered open-label in pill form. Asenapine will be initiated at 5 mg twice a day and increased as tolerated to a maximum of 20 mg/day. It is anticipated that maximum stable dosing will be achieved by 4 weeks of treatment, although dosage may be reduced due to tolerability concerns at the discretion of the treating research psychiatrist.
16191559|NCT01460277|Procedure|Hydrokinesiotherapy Intervention|The hydrotherapy exercise intervention consisted of 5 minutes of warm-up, 10 minutes of lower-extremity stretching exercises, 10 minutes of lower-extremity strengthening exercises, 20 minutes balance and gait training (water walking, running, side stepping), 5 minutes of a light cool down (marching on the spot), and 10 minutes of gentle stretching in the water.
16191560|NCT01460277|Procedure|Land-based exercise intervention|The conventional exercise intervention used no water-based exercises but land-based exercises. The exercise program consisted of 5 minutes of warm-up, 10 minutes of lower-extremity stretching exercises, 10 minutes of lower-extremity strengthening exercises, 20 minutes balance and gait training (walking, side stepping), 5 minutes of a light cool down, and 10 minutes of gentle stretching out of the water.
16191561|NCT01460251|Drug|DiaPep277|1.0 mg DiaPep277® administered every 3 months.For patients who just completed the 2-year 901 study, a 3-year extended treatment will be offered with 13 administrations; patients who completed the 2-year 910 extension study will be offered a 3rd year of treatment with 5 additional administrations.
16191562|NCT01460225|Drug|lubiprostone|24 micrograms twice daily for 1 week
16191563|NCT01460212|Drug|SSRI antidepressants|SSRI antidepressants are Selective serotonin reuptake inhibitors. They include fluoxetine (Prozac); sertraline (Zoloft); paroxetine (Paxil); citalopram (Celexa) ;escitalopram (Lexapro) and fluvoxamine (Luvox). It will be chosen according to special condition of every patient.
16191564|NCT01460212|Behavioral|Cognitive-Behavior Therapy|The essence of CBT is a learning process through which an appropriate pattern in cognitive and behavioral could be learn and stored as memory
16191565|NCT01460199|Drug|CTP-499|"3 X 200 mg tablets (QD for 2 weeks)
~3 x 200 mg tablets (BID for 2 weeks)"
16191566|NCT01460199|Drug|placebo|tablets
16191567|NCT01460186|Other|Blood sample for genetic analysis (Identification of germ line genetic factors that influence the risk of metastatic breast cancer)|Blood samples will be collected in one 6 ml EDTA and one 6 ml ACD tube after informed consent and inclusion in the study.
16191568|NCT01460173|Other|Divided Attention Steering Simulator (DASS)|Half-hour divided attention test with steering wheel after 5 to 10 minutes of practice. Completion of three questionnaires (ESS, Young, Berlin Questionnaire).
16191569|NCT01460160|Drug|Dasatinib|Tablets, Oral, 60 mg/m2, Once daily, 2 years or until unacceptable toxicity
16191570|NCT01460147|Other|DXA scan + MRI|This is a non-drug study. Subjects will receive a dual-energy X-ray absorptiometry (DXA) scan (in the main osteoporosis study) and will undergo magnetic resonance imaging (in the MRI substudy).
16191571|NCT01460134|Drug|CDX-1127|"Patients will initially receive a single dose of CDX-1127, followed by a 28-day observation period and a Multi-Dose Phase (one cycle of 4 weekly doses of CDX-1127). All patients with stable disease who do not experience a DLT or start alternate anti-cancer treatments may then be eligible for a Retreatment Phase (up to 4 additional cycles). Patients with confirmed partial response or complete response will be followed for response duration and may be eligible for additional cycles of treatment at the time of relapse/progression.
~The dose of CDX-1127 given for the Dose Escalation phase will depend on the cohort each patient is assigned to, and will range between 0.1 and 10.0 mg/kg of CDX-1127."
16191572|NCT01460134|Drug|CDX-1127|"Patients will receive 4 weekly doses of CDX-1127 followed by an observation period. All patients with stable disease who do not experience a DLT or start alternate anti-cancer treatments may then be eligible for a Retreatment Phase (up to 4 additional cycles). Patients with confirmed partial response or complete response will be followed for response duration and may be eligible for additional cycles of treatment at the time of relapse/progression."
16191573|NCT01460134|Drug|CDX-1127|"Patients will receive four doses of CDX-1127 administered every three weeks followed by an observation period. All patients with stable disease who do not experience a DLT or start alternate anti-cancer treatments may then be eligible for a Retreatment Phase (up to 4 additional cycles). Patients with confirmed partial response or complete response will be followed for response duration and may be eligible for additional cycles of treatment at the time of relapse/progression."
16191574|NCT01460121|Device|SpotOn's corrective elements for dizziness|Eyeglasses with dizziness correction elements (real SpotOn eyeglasses) or eyeglasses with placebo (sham eyeglasses) elements will be worn during the whole four weeks study period.
16191575|NCT01460121|Device|Placebo|
16191576|NCT01460108|Device|AeriSeal System|20 mL
16191577|NCT01460095|Other|HbA1c measurement and education|three-monthly point of care measurement of HbA1c with immediate feedback to patients and provision of interpretation and targeted one-to-one education
16191578|NCT01460069|Drug|liraglutide|Victoza® is supplied in pens for injection containing 18 mg of the GLP-1 agonist liraglutide in 3 mL sterile water with disodiumphosphate and propylenglycol, and phenol for conservation (pH 8.15). Commercial pens will be used and the information given in the packaging will be applicable. The initial daily dose will be 0.6 mg for one week, 1.2 mg the following week and then 1.8 mg for the remaining treatment period. The injection is administered once daily in the morning. The maximal plasma concentration is reached 8-12 hours after subcutaneous injection. The half-life in plasma is approximately 13 hours. The duration of effect is 24 hours.
16191579|NCT01460069|Drug|Placebo|The placebo pens contain saline and are administered in the same way and volume as (liraglutide) Victoza. The placebo pens are specially prepared for this study and will be used in the study only.
16191580|NCT01460043|Drug|Homeopathy|Each homeopathic medication was given as 1 g dose of homeopathic preparation in 30c potency. The dose is prepared as lactose globules on which the homeopathic preparation.
16191581|NCT01460043|Drug|placebo|corresponding placebo was identical in appearance of homeopathic globule prepared in alcohol.
16191582|NCT01460030|Drug|Cinacalcet HCl|Oral administration
16191583|NCT01460017|Procedure|Deep Sclerectomy|Non penetrating glaucoma surgery is a new procedure in adults that has less post operative complications with good results, it is to be applied in children.
16191584|NCT01460017|Procedure|Combined Trab|Combined trabeculectomy and trabeculotomy is a standard surgery for congenital glaucoma, however, it has its known complications.
16191585|NCT01460004|Device|patella knee strap|infra patella strap 100% cotton pressure is exerted immediately under the patella
16191586|NCT01459991|Other|Walnut|Participants will consume 1 ounce walnuts daily and follow a Mediterranean style diet.
16191587|NCT01459991|Other|MyPyramid|Participants will follow a USDA MyPyramid style diet for lactating moms.
16191588|NCT01459978|Other|CUmulative SUM (CUSUM) Chart|"Intervention is described as follows:
~Step 1: Implementation of the CUmulative SUM (CUSUM)control chart using available medical data Step 2: Submission of monthly results to the coordinator of each participating center (if CUmulative SUM (CUSUM) results period).
~Step 3: When an alarm is generated, the steering committee will meet with maternity staff to find the causes of these alerts and propose"
16191589|NCT01459965|Procedure|ERCP with 10 French biliary plastic stent placement|Stent placement of a 10 French biliary plastic stent
16191590|NCT01459965|Procedure|ERCP with 11.5 French biliary plastic stent|biliary plastic stent placement
16191591|NCT01459952|Dietary Supplement|Rose hip Liquid|Rose hip Liquid, 20 ml BID
16191592|NCT01459939|Dietary Supplement|Rose-hip powder capsules|5 x 0,5 g rose-hip powder capsules BID the first 3 weeks and decreasing to 5 x 0,5 g QD the following 9 weeks
16191593|NCT01459939|Dietary Supplement|Placebo|5 x 0,5 g placebo powder capsules BID the first 3 weeks and decreasing to 5 x 0,5 g QD the following 9 weeks
16191594|NCT01459926|Drug|TD-1211|once daily
16191595|NCT01459926|Drug|TD-1211|Once daily
16191596|NCT01459926|Drug|TD-1211|Once daily
16191597|NCT01459926|Drug|Placebo|Once daily
16191598|NCT01459913|Drug|Telaprevir|Tablet
16191599|NCT01459913|Drug|Pegylated Interferon Alfa-2a|Subcutaneous Injection
16191600|NCT01459913|Drug|Ribavirin|Tablet
16191601|NCT01459900|Procedure|Renal artery ablation|Catheter based renal denervation by applying low power radiofrequency to the renal artery using the Ardian Medtronic Simplicity Catheter, introduced by femoral artery access.
16191602|NCT01459900|Procedure|Renal angiography|Renal angiography by femoral access.
16191603|NCT01459887|Drug|CHOP combined with CMAB304|Patients treated with CHOP-304 undergo 1 cycle every 3 weeks, received CMAB304 at a dose of 375 mg/m2 on day 1 and CHOP on day 2 of each of the 6 cycles.
16191604|NCT01459887|Drug|CHOP, CMAB304|First standard CHOP, then sequential CMAB304 in patients who reached a complete response or undocumented complete response at the end of treatment of 6 cycles.
16191605|NCT01459874|Behavioral|Organizational model for remote monitoring|An organizational model defining roles and behaviors of subjects involved in the remote monitoring of pacemaker and defibrillator recipients
16191606|NCT01459861|Procedure|Canal Block and Capsular Injection|Continuous Adductor canal block with 15ml of ropivacaine 0.2% with epinephrine 1:400,000 followed by an infusion of ropivacaine 0.2% at 6ml per hour for 2 days post operatively. This is combined with ultrasound guided posterior capsular knee injection with 30ml ropivacaine 0.2% with epinephrine 1:400,000.
16191607|NCT01459861|Procedure|Femoral Nerve Block with Tibial Nerve Block|Continuous femoral nerve block with 15ml of ropivacaine 0.2% followed by an infusion of ropivacaine 0.2% at 6ml per hour for 2 days after surgery combined with tibial nerve block in the popliteal fossa with ropivacaine 0.5% up to 15ml.
16191608|NCT01459848|Behavioral|block play|30 minutes of block play
16191609|NCT01459848|Behavioral|baby dvd|30 minutes of dvd viewing
16191610|NCT01459835|Behavioral|media diet|advice and tips and tools for healthy non violent TV viewing
16191611|NCT01459835|Behavioral|nutritional intervention|advice on healthy eating
16191612|NCT01459809|Drug|GLIMEPIRIDE|"Pharmaceutical form: oral
~Route of administration: oral"
16191613|NCT01459809|Drug|METFORMIN|"Pharmaceutical form: oral
~Route of administration: oral"
16191614|NCT01459796|Drug|Rilonacept|Rilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 52 weeks.
16191615|NCT01459796|Drug|Placebo|Placebo loading dose followed by placebo injections (2 mL) qw for 52 weeks.
16191616|NCT01459796|Drug|Allopurinol|Allopurinol 50 or 100 mg, orally daily for 52 weeks as background treatment.
16191654|NCT01459523|Procedure|Distal placement|Subjects assigned to this group will have their perineural catheter placed in a distal position (further down in the arm or leg) with ultrasound guidance. The onset time of sensory anesthesia will be measured following local anesthetic bolus via the catheter.
16195717|NCT01428622|Drug|BI54903|ethanolic solution
16191617|NCT01459783|Behavioral|Dementia care management|Care management is initiated via a structured assessment, to identify prevalent caregiving problems: unmet need for assistance, lack of social support, educational needs, difficulty with managing behavioral issues and safety concerns, need for respite, establishing advance care planning, depression of the person with dementia as well as the caregiver, management of other chronic medical issues, and need for diagnostic information and assistance with acute medical issues. Collaboration between the caregiver and the care manager results in problem prioritization and subsequent counseling, education, referrals as needed, and proactive follow-up to achieve resolution of these problems. An electronic tracking tool and resource manual guide delivery of the care management protocols.
16191618|NCT01459770|Other|Medication Information Transfer Intervention|A pharmacist will visit participants randomized to the intervention group in their homes within 5 days of hospital discharge to administer the 5As Medication Self-Management intervention: Assessment, Advise, Agreement, Assistance, Arrangements.
16191619|NCT01459770|Other|Usual care for hospital discharge|Patients will receive medication information according to standard practice for discharge of hospitalized patients.
16191620|NCT01459757|Other|non-interventional|Non-interventional; Mutational status data analyzed previously but not collected in the A6181036 study, will be correlated wth A6181036 clinical outcomes data collected during the A6181036 study.
16191621|NCT01459744|Behavioral|Communication training for cardiologists.|"Communication training: a 90 minute workshop to discuss ways to improve communication in patients with serious illness.
~Reminders to Cardiologists. Cardiologists will receive reminders to prompt them to have conversations relating to ICD management with patients enrolled in the study.
~Audit and feedback. Cardiologists will receive feedback on their rates of conversation as well as data on patient/family satisfaction with their communication skills."
16191622|NCT01459744|Other|Control arm|Cardiology grand rounds will be held at usual care sites on the importance of advance care planning.
16191623|NCT01459718|Drug|Deferasirox|20-40 mg/kg/day orally, once daily
16191624|NCT01459718|Drug|Deferoxamine (DFO)|40 mg/kg/day subcutaneous (sc) infusion, 3-4 days per week
16191625|NCT01459705|Behavioral|Prolonged Exposure Therapy (PE)|Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.
16191626|NCT01459705|Behavioral|Virtual Reality Exposure Therapy (VRET)|Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments.
16191627|NCT01459705|Behavioral|Waitlist|This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation
16191628|NCT01459692|Other|Music Exposure|Twenty-seven subjects were randomly assigned to receive nightly exposure to music at periodic intervals between the hours of 9:00 PM and 8:00 AM.
16191629|NCT01459679|Device|KXL System (15 mW/cm2)|UVA irradiation for 8 minutes at 15 mW/cm2
16191630|NCT01459679|Device|KXL System (30 mW/cm2)|UVA irradiation for 4 minutes at 30 mW/cm2
16191631|NCT01459679|Device|KXL System (45 mW/cm2)|UVA irradiation for 2 minutes 40 seconds at 45 mW/cm2
16191632|NCT01459679|Drug|riboflavin ophthalmic solution|Drops of riboflavin ophthalmic solution will be applied in the eye every two minutes for 20 minutes
16191633|NCT01459666|Drug|Dysport (abobotulinumtoxinA)|Intramuscular injection effects lasting up to 3 months
16191634|NCT01459666|Drug|Bacteriostatic 0.9% Sodium Chloride (vehicle)|Intramuscular injection
16191635|NCT01459640|Drug|Hyaluronic Acid|Intra-articular injection; 30mg/2ml; three-weekly injection regimen
16191636|NCT01459640|Biological|Autologous bone marrow-derived mesenchymal stem cells|"Single intra-articular implantation of autologous bone marrow-derived mesenchymal stem cells in hyaluronic acid Orthovisc (3rd injection in a three-weekly injection regimen)"
16191637|NCT01459627|Other|6 months DAPT|Dual antiplatelet therapy will be stopped at randomisation to the 6 months DAPT group. Patients will be treated from 6 months onwards only with ASA.
16191638|NCT01459627|Other|12 months DAPT|Dual antiplatelet therapy will be continued till 12 months after enrollment in the study
16191639|NCT01459614|Drug|Gemcitabine|IV on Days 4 and 11
16191640|NCT01459614|Drug|Taxotere|IV on Days 4 and 11
16191641|NCT01459614|Drug|Xeloda|orally, twice a day Days 1-14
16191642|NCT01459614|Drug|Cisplatin|IV Days 4 and 11
16191643|NCT01459601|Drug|Cabergoline|0,5mg per week
16191644|NCT01459588|Drug|Carboxymethylcellulose Based Eye Drop Formulation A|Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
16191645|NCT01459588|Drug|Carboxymethylcellulose Based Eye Drop Formulation B|Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
16191646|NCT01459588|Drug|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops|Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.
16191647|NCT01459588|Drug|Carboxymethylcellulose Based Lubricant Eye Drops|Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.
16191648|NCT01459562|Drug|NI-0501|
16191649|NCT01459562|Drug|Placebo|
16191650|NCT01459549|Procedure|Roux-en-Y choledochojejunostomy|Roux-en-Y choledochojejunostomy must be operated
16191651|NCT01459523|Procedure|Proximal placement|Subjects assigned to this group will have their perineural catheter placed in a proximal position (higher up in the arm or leg) with ultrasound guidance. The onset time of sensory anesthesia will be measured following local anesthetic bolus via the catheter.
16191652|NCT01459523|Procedure|Short axis ultrasound|Subjects assigned to this group will have the target nerve or plexus identified in short axis (cross-section) using ultrasound. Perineural catheter insertion will be performed in-plane. The onset time of sensory anesthesia will be measured following local anesthetic bolus via the catheter.
16191653|NCT01459523|Procedure|Long axis|Subjects assigned to this group will have the target nerve or plexus identified in long axis (longitudinal) using ultrasound. Perineural catheter insertion will be performed in-plane. The onset time of sensory anesthesia will be measured following local anesthetic bolus via the catheter.
16191655|NCT01459510|Behavioral|Play Nicely Program|Multi media educational intervention
16191656|NCT01459497|Radiation|Radiation Therapy|Image-Guided Radiation Therapy (IGRT)60 Gy in 15 fractions in 3 weeks
16191657|NCT01459497|Radiation|Conventional radiation|Conventional radiation 60-66 Gy in 30-33 fractions in 6-7 weeks
16191658|NCT01459484|Drug|Mifamurtide arm|"PRE SUGERY TREATMENT:
~Methotrexate: 12g/m2 (3 cycles) Cisplatinum: 120mg/m2 (3 cycles) Doxorubicin: ADM 75mg/m2 (3 cycles)
~POST SURGERY TREATMENT for good responder patients with positive P-GLYCOPROTEIN
~Methotrexate 12g/m2 (10 Cycles) Cisplatinum 120mg/m2; Doxorubicin 90mg/m2 MEPACT 2 mg/m2 twice a week for the first 3 months the weekly for the next 6 months (total lenght treatment 44 weeks)
~POST SURGERY TREATMENT for poor responder patients with positive P-GLYCOPROTEIN
~Methotrexate 12g/m2; Cisplatinum 120mg/m2; Doxorubicin 90mg/m2 ifosfamide 15g/m2 MEPACT 2 mg/m2 twice a week for the first 3 months the weekly for the next 6 months (total lenght treatment 44 weeks)
~All the product are used as commercial formulation"
16191659|NCT01459484|Other|3 drugs arm|"High grade osteosarcoma who do not over express ABCB1/P-glycoprotein will be treated with a standard 3-drugs regimen
~PRE-SUGERY TREATMENT:
~Methotrexate: 12g/m2 (3 cycles) Cisplatinum: 120mg/m2 (3 cycles) Doxorubicin: ADM 75mg/m2 (3 cycles)
~POST SURGERY TREATMENT:
~Methotrexate 12g/m2 (10 cycles) Cisplatinum 120mg/m2; Doxorubicin 90mg/m2
~Total lenght 34 weeks
~All the product are used as commercial formulation"
16191660|NCT01459471|Procedure|Bariatric surgery|Staple line reinforcement during sleeve gastrectomy
16191661|NCT01459458|Behavioral|Family Planning-based Partner Violence Intervention|"The intervention includes three major components:
~Enhanced Screening and Education: scripted questions to assess for reproductive coercion and pregnancy risk combined with intimate partner violence (IPV) assessment and education regarding how IPV may affect women's reproductive health with the assistance of a safety/educational card created for this intervention.
~Harm Reduction Counseling: assisting clients in identifying and planning strategies to reduce their risk for future unintended pregnancies and IPV.
~Supported Referral: educating all clients regarding local resources for victims of IPV and problem-solving regarding barriers to acquisition of these resources as needed."
16191662|NCT01459445|Drug|Metformin, Ethinylestradiol 30µg-Drospirenone|Metformin: 1700 mg /day (twice per day)-6 months; EE30µg-drospirenone: 1 tb/day, 21 days/month, 6 months
16191663|NCT01459432|Other|Venepuncture and blood sample collection.|Venepuncture and blood sample collection.
16191664|NCT01459419|Drug|anti-CD3 monoclonal antibody|Oral anti-CD3 MAb will be administered at a dosage level of 0.2 or 1.0 or 5.0 mg per day for 30 days. One 20mg tablet of Omeprazole (a proton pump inhibitor) will be taken concomitantly orally
16191665|NCT01459419|Drug|Sodium Chloride placebo|Sodium chloride will be administered orally every day for 30 days. Up to 9 subjects will be treated at each dosage level. One 20mg tablet of Omeprazole (a proton pump inhibitor) will be taken concomitantly orally
16191666|NCT01459406|Dietary Supplement|Glucose|500 ml water drink containing 40g glucose
16191667|NCT01459406|Dietary Supplement|Fructose|500 ml water drink containing 40g fructose
16191668|NCT01459406|Dietary Supplement|Fructan|500 ml water drink containing 40g fructan
16191669|NCT01459406|Dietary Supplement|Fructose and glucose|500 ml water drink containing 40g fructose and 40g glucose
16191670|NCT01459393|Drug|5-ALA Photodynamic Therapy|
16191671|NCT01459393|Drug|Cryotherapy with liquid nitrogen|Topical application of liquid nitrogen spray (500ml Cry-ac ® bottle) over the actinic keratosis lesion and over a 0,5 cm margin around it during sufficient time to freeze both the lesion and margin.
16191672|NCT01459380|Biological|Bevacizumab|Given IV
16191673|NCT01459380|Drug|Carboplatin|Given IV
16191674|NCT01459380|Other|Laboratory Biomarker Analysis|Correlative studies
16191675|NCT01459380|Drug|Pegylated Liposomal Doxorubicin Hydrochloride|Given IV
16191676|NCT01459380|Drug|Veliparib|Given PO
16191677|NCT01459367|Drug|TAK-438|"In the treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.
~In the maintenance treatment period, the participants will receive treatment of TAK-438 10 mg, tablets, orally, once daily and lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks."
16191678|NCT01459367|Drug|TAK-438|"In the treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.
~In the maintenance treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily and lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks."
16191679|NCT01459367|Drug|Lansoprazole|"In the treatment period, the participants will receive treatment of TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.
~In the maintenance treatment period, the participants will receive treatment of TAK-438 placebo-matching tablets, orally, once daily and lansoprazole 15 mg, capsules, orally, once daily for up to 24 weeks."
16191680|NCT01459328|Radiation|Radiotherapy|"Short course radiotherapy: 25Gy in 5 daily fractions over 1 week Chemotherapy: - Bolus 5 Fluorouracil 450 mg/m2/day
~Injected Leucovorin 20 mg/m2/day for 5 days"
16191681|NCT01459328|Radiation|Radiotherapy|"Conventional long course chemo-radiation:
~Radiation 50Gy in 25 daily fractions over 5 weeks
~Bolus 5 Fluorouracil 350mg/m2/d for 5 days
~Injected Leucovorin 20mg in both the first and last (5th) week of radiation
~Oral Capecitabine (CAPE) 825mg/m2 b.i.d. during the entire radiotherapy course over 5 weeks."
16191682|NCT01459315|Drug|dolutegravir|Subjects will take a GSK1349572 (dolutegravir) 50mg tablet by mouth once daily for 8 days. GSK1349572 concentrations will be measured in blood plasma, seminal fluid, rectal fluid, and rectal tissue over 24 hours after a single dose and over two 24 hour periods once steady state is reached. Blood plasma will be collected pre-dose and 1, 2, 3, 4, 5, 6, 8, 12, 18, and 24 hours after dosing. Each subject will also provide a total of 9 seminal and rectal fluid samples and have 2 rectal tissue biopsies performed pre-dose or at 1, 3, 6, 12, 18, or 24 hours after receiving single or multiple doses.
16191683|NCT01459289|Other|leaflet|
16191684|NCT01459289|Other|counseling and leaflet|
16191685|NCT01459276|Biological|Vaccination with FAB-6011|One 0.5 mL injection of FAB-6011 trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.
16191686|NCT01459276|Biological|Vaccination with FluvalAB|One 0.5 mL injection of FLUVAL AB trivalent influenza vaccine containing 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.
16191687|NCT01459263|Device|ClariVein|Using the ClariVein device, the GSV will be occluded.
16191688|NCT01459250|Drug|AGO178C|
16191689|NCT01459237|Drug|Acthrel|Ovine Corticorelin
16195718|NCT01428622|Drug|BI54903|ethanolic solution
16191690|NCT01459211|Drug|Lenalidomide & Dexamethasone|"Subjects with relapsed or refractory CLL will receive twelve 28-day cycles of treatment. Each cycle will consist of:
~Oral Dexamethasone (20mg daily, days 1-4),
~Oral Lenalidomide on days 1-28 of each cycle, starting at 5mg per day in cycle 1 in patients with creatinine clearance ≥ 60ml/min calculated by Cockcroft-Gault. The dose will be increased to 10mg per day with cycles 2-12 unless there is evidence of disease progression or unacceptable drug toxicity"
16191691|NCT01459198|Biological|RSV MEDI ΔM2-2 vaccine|Given intranasally once at a baseline study visit, at a dose of 10^5 or 10^6 plaque-forming units (PFU), depending on study arm.
16191692|NCT01459198|Biological|Placebo vaccine|Given intranasally once at a baseline study visit
16191693|NCT01459185|Drug|S-1|Chemotherapy comprised eight courses (4-week administration, 2-week withdrawal; total 1 year) of S-1 at 80-120 mg/body/day according to body surface area (BSA)
16191694|NCT01459172|Other|limonene containing massage oil|daily massage application to the breast for 4 weeks
16191695|NCT01459159|Drug|ezatiostat hydrochloride (Telintra®)|Three weeks of treatment with ezatiostat at 2000 mg per day in divided doses followed by a one week rest period in four-week treatment cycles.
16191696|NCT01459146|Drug|Artemether-lumefantrine combination plus albendazole|AL: 20mg/120mg 12-hourly orally for 3 days ABZ: 400mg oral stat
16191697|NCT01459146|Drug|Artemether-lumefantrine plus Praziquantel plus Albendazole|Artemether-lumefantrine 20mg/120mg 12 hourly for 3 days, plus praziquantel 40mg/kg stat, plus albendazole 400mg stat oral
16191698|NCT01459146|Drug|Albendazole plus Praziquantel|Albendazole 400mg stat plus Praziquantel 40mg/kg stat oral
16191699|NCT01459133|Drug|Technosphere® Insulin Inhalation System|Single Site, Single Subject use of Technosphere® Insulin Inhalation System
16191700|NCT01459120|Other|Door-to-door|Health workers propose the integrated service package including VCT at the peoples' homes (home-based testing).
16191701|NCT01459120|Other|Pitso|"Health care workers propose the integrated service package including VCT through community gatherings (Pitso)."
16191702|NCT01459107|Procedure|Deceased donor hand transplantation|Deceased donor hand is surgically attached to recipient arm's stump.
16191703|NCT01459107|Drug|Bone marrow cell-based therapy & single-drug immunosuppression.|This protocol uses a novel bone marrow cell-based therapy for composite tissue allotransplantation (CTA) rather than conventional triple-drug immunosuppression to facilitate long-term graft survival of deceased donor human upper extremities under low-dose maintenance immunosuppression. Initial T-cell depletion with alemtuzumab is followed by upper extremity transplantation and tacrolimus maintenance therapy. Donor bone marrow cells are infused on Day 10 (±4 days) post-transplantation to elicit a host alloimmune response triggering exhaustion and deletion of the respective host (anti-donor) lymphocyte clones. Subsequently, tacrolimus therapy is given for at least 6 months before spaced weaning is considered in stable recipients.
16191704|NCT01459094|Drug|A (CANA/MET IR FDC tablet - fasting state) / B (CANA/MET IR FDC tablet - fed state)|Treatment A: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally (by mouth) in a fasting state on Day 1 of Treatment Period 1 followed 10-14 days later by Treatment B: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally in a fed state on Day 1 of Treatment Period 2.
16191705|NCT01459094|Drug|B (CANA/MET IR FDC tablet - fed state) / A (CANA/MET IR FDC tablet - fasting state)|Treatment B: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally in a fed state on Day 1 of Treatment Period 1 followed 10-14 days later by Treatment B: Type = 1, unit = mg, number = 150/1000, form = tablet, route = oral use. One CANA/MET IR FDC tablet taken orally in a fasting state on Day 1 of Treatment Period 2.
16191706|NCT01459081|Drug|Zanamivir|10 mg inhaled by mouth, twice daily, for 5 days
16191707|NCT01459081|Drug|Placebo|inhaled by mouth, twice daily, for 5 days
16191708|NCT01459068|Behavioral|Common Elements Treatment Approach|"CETA components include:
~Engagement (encouraging participation)
~Psychoeducation (introduction)
~Anxiety Management Strategies (relaxation)
~Behavioral Activation (getting active)
~Cognitive Coping/Restructuring (thinking in a different way, part I and part II)
~Imaginal Gradual Exposure (talking about difficult memories)
~In Vivo Exposure (Live exposure)
~Suicide/Homicide/Danger Assessment and Planning (safety)
~Screening and Brief Intervention for Alcohol (alcohol intervention)"
16191709|NCT01459029|Drug|D-serine|Adjuvant treatment with D-serine up to 6000 mg/day vs. placebo
16191710|NCT01459016|Other|PET scan using florbetapir|A single intravenous microdose of 260 MBq (7 mCi) 18F-AV-45 (florbetapir F 18) will be administered.
16191711|NCT01459016|Other|MRI Scan|Three different measurements will be taken: volumetric MRI (vMRI), diffusion tensor imaging (DTI), and resting state functional MRI (rsfMRI). In addition, radiological MRI scans will be taken to monitor vasogenic edema and microhemorrhages.
16191712|NCT01459003|Other|beauty care|beauty care performed before each chemo cycle
16191713|NCT01458990|Drug|Omeprazole|20mg PO BID for 20 days
16191714|NCT01458977|Drug|Truvada® (300 mg tenofovir disoproxil fumarato/200 mg emtricitabine)|TDF/FTC 300/200mg daily during 3 months + Placebo during 6 months
16191715|NCT01458977|Drug|Placebo|Placebo during 3 months + TDF/FTC 300/200mg daily during 3 months + Placebo during 3 months
16191716|NCT01458964|Drug|Quetiapine|100 mg (peach colored oblong tablet) and 200 mg (yellow colored oblong tablet)
16191717|NCT01458951|Drug|tofacitinib|10 mg oral BID
16191718|NCT01458951|Drug|Placebo|Placebo oral BID
16191719|NCT01458938|Other|treatment plan|Data Collection Study
16191720|NCT01458925|Device|The P1 Check-Cap capsule|The P1 Check-Cap capsule will be ingested by all participants. After the Capsule test, they will be referred for optical colonoscopy as part of the study
16191721|NCT01458912|Drug|Placebo matching Respimat|2 puffs a.m. via Respimat inhaler
16191722|NCT01458912|Drug|Placebo matching Respimat|2 puffs a.m. via Respimat inhaler
16191723|NCT01458912|Drug|BI 54903 MD|2 puffs MD b.i.d. via Respimat inhaler
16191724|NCT01458912|Drug|BI 54903 HD|2 puffs HD p.m. via Respimat inhaler
16191725|NCT01458899|Drug|TC-5214|Oral tablets, single 4mg dose
16191726|NCT01458886|Drug|BI 54903 MD|2 puffs b.i.d. via Respimat inhaler
16191727|NCT01458886|Drug|Placebo matching Respimat|2 puffs a.m. via Respimat inhaler
16191728|NCT01458886|Drug|Placebo matching Respimat|2 puffs a.m. via Respimat inhaler
16191729|NCT01458886|Drug|BI 54903|2 puffs LD b.i.d. via Respimat inhaler
16191730|NCT01458873|Drug|sodium bicarbonate 4.2%|diluted sodium bicarbonate 50 ml
16191731|NCT01458873|Drug|diluted sodium bicarbonate 2.1%|50ml
16191732|NCT01458873|Drug|normal saline|50ml
16191733|NCT01458847|Drug|cis-UCA solution|Cohort I: 2% cis-UCA solution (50 ml); min 3, max 12 patients
16191734|NCT01458847|Drug|cis-UCA solution|Cohort II: 4% cis-UCA solution (50 ml); min 0, max 12 patients
16191735|NCT01458847|Drug|cis-UCA solution|Cohort III: 6% cis-UCA solution (50 ml); min 0, max 12 patients
16191736|NCT01458834|Behavioral|Attention bias modification task|Participants will complete a computerized probe-discrimination task from their home computer or handheld electronic device 3 times per day for one week. Each training session will consist of 160 trials. In each trial, two pictures (smoking-related or neutral) will appear on the screen simultaneously and then disappear. An arrow will appear in the location of one of the pictures (< or >). Participants are asked to quickly identify the direction of the arrow by pressing a button. In the active training task, the arrow will replace the neutral pictures 80% of the time.
16191737|NCT01458834|Behavioral|Control Condition|Participants will complete a computerized probe-discrimination task from their home computer or handheld electronic device 3 times per day for one week. Each training session will consist of 160 trials. In each trial, two pictures (smoking-related or neutral) will appear on the screen simultaneously and then disappear. An arrow will appear in the location of one of the pictures (< or >). Participants are asked to quickly identify the direction of the arrow by pressing a button. In the control training task, the arrow will replace the neutral and smoking-related pictures with equal frequency.
16191738|NCT01458821|Behavioral|Brain Fitness Program - Tinnitus|Brain Fitness Program-Tinnitus was developed to improve cognitive function by engaging the brain's neuroplasticity; the program is novel, non-invasive, and inexpensive.
16191739|NCT01458808|Other|Dietary sodium restriction|Restriction of 2 grams on daily sodium diet intake.
16191740|NCT01458808|Other|Dialysate sodium concentration reduction|Reduction of dialysate sodium concentration from 138 to 135 mEq/L
16191741|NCT01458795|Procedure|Endovenous laser ablation|
16191742|NCT01458782|Procedure|Treatment of cartilage defects in the knee|Two groups, either ACI or AMIC. ACI includes an arthroscopy for harvesting of cartilage 3-4 weeks prior to the open cartilage surgery. AMIC includes only open surgery at one setting.
16191743|NCT01458769|Drug|C-10276|C-10276 200 mg, C-10276 400 mg, Reyataz 400 mg oral, single dose
16191744|NCT01458769|Drug|C-10276|C-10276 300 mg, CTP-518 100 mg with C-10276 300 mg, C-10276 400 mg oral, single dose
16191745|NCT01458769|Drug|C-10297|C-10297 200 mg, oral, single dose
16191746|NCT01458769|Drug|C-10299|C-10299 200 mg, oral, single dose
16191747|NCT01458769|Drug|C-10297|C-10297 400 mg, Reyataz 400 mg, C-10297 600 mg, oral, single dose
16191748|NCT01458769|Drug|C-10299|C-10299 400 mg, Reyataz 400 mg, C-10299 600 mg, oral, single dose
16191749|NCT01458769|Drug|C-10276|C-10276 600 mg, Reyataz 400 mg, Reyataz 600 mg, oral, single dose
16191750|NCT01458769|Drug|Reyataz®|Reyataz 400 mg, oral, single dose Reyataz 600 mg, oral, single dose
16191751|NCT01458743|Drug|Ceftaroline|60-minute single intravenous dose of 600 mg of Ceftaroline on Days 1 and 8; 60-minute intravenous dose of 600 mg of Ceftaroline twice per day on Days 3-7.
16191752|NCT01458743|Drug|Ceftaroline|Single intravenous dose on Days 1 and 9. Intravenous three times per day on Days 2-8.
16191753|NCT01458730|Drug|Immunochemotherapy|Rituximab, HD-MTX, HD-Ara C, Cyclophosphamide, Iphosphamide, Vincristin, Vindesin, Temozolomide, Depocyte
16191754|NCT01458717|Drug|Neoadjuvant chemoradiation|"Neoadjuvant chemoradiation; 45Gy/25fx + 9Gy/5fx of radiation over 6 weeks with Gemcitabine 400mg/㎡
~4 weeks rest, re-evaluation for resectability
~operation
~start maintenance chemotherapy within 4~6 weeks after operation with Gemcitabine 1000mg/㎡ (D1, 8, 15) every 4 weeks, for 4 cycle"
16191755|NCT01458717|Procedure|Upfront surgery|"Operation at time of diagnosis
~Adjuvant chemoradiation; 45Gy/25fx + 9Gy/5fx of radiation over 6 weeks with Gemcitabine 400mg/㎡
~start maintenance chemotherapy within 4~6 weeks after completion of adjuvant chemoradiation with Gemcitabine 1000mg/㎡ (D1, 8, 15) every 4 weeks, for 4 cycle"
16191756|NCT01458704|Other|next generation sequencing|next generation sequencing (including targeted gene sequencing, exome sequencing, transcriptome sequenicing)
16191757|NCT01458691|Procedure|Steroid injection into the glenohumeral joint|"Group: Steroid
~Total volume of injection drugs: 4ml(1ml of triamcinolone acetonide 40mg/ml + 3ml of 2% lidocaine)
~The number of injections : only once during the study period
~Injection site : glenohumeral joint
~Material : 25-gauze spinal needle
~The intra-articular injections were performed using ultrasonographic guidance."
16191758|NCT01458691|Procedure|Allogeneic PRP injection into the glenohumeral joint|"Group: Allogeneic PRP
~Total volume of injection drugs: 4ml
~The number of injections : only once during the study period
~Injection site : glenohumeral joint
~Material : 25-gauze spinal needle
~The intra-articular injections were performed using ultrasonographic guidance."
16191759|NCT01458678|Other|Volume of colloid infusion|Colloid infusion is primarily given as hydroxyethyl starch 60 mg/ml. If more than 30 ml/kg hydroxyethyl starch 60 mg/ml is given, colloid solution is changed to albumin 4% or plasma.
16191760|NCT01458678|Other|Volume of colloid infusion|Colloid infusion is given primarily as hydroxyethyl starch 60 mg/ml. If more than 30 ml/kg hydroxyethyl starch 60 mg/ml is given, colloid solution is changed to albumin 4% or plasma.
16191761|NCT01458665|Procedure|Conventional arthroscopic rotator cuff repair|"Under general anesthesia, the patient was placed in the lazy lateral decubitus position on the operating table.
~The surgical area was prepared and draped with Betadine.
~Small stab incisions were made in the creation of 4-5 portals as needed.
~A scope was explored via the arthroscopic portal into the GH joint & subacromial space.
~Repair of full thickness rotator cuff tear was done with suture anchors.
~The skin was closed with Nylon or medical staples.
~Sterile dressing was applied on surgical wound."
16191762|NCT01458665|Procedure|Arthroscopic rotator cuff repair with PRP|"Under general anesthesia, the patient was placed in the lazy lateral decubitus position on the operating table.
~The surgical area was prepared and draped with Betadine.
~Small stab incisions were made in the creation of 4-5 portals as needed.
~A scope was explored via the arthroscopic portal into the GH joint & subacromial space.
~Repair of full thickness rotator cuff tear was done with suture anchors.
~After tying sutures of the medial row, PRP gels were applied on the repair site.
~The lateral row was secured using suture anchors.
~The skin was closed with Nylon or medical staples.
~Sterile dressing was applied on surgical wound."
16191763|NCT01458652|Drug|Kremezin|Kremezin is an oral adsorbent, 9g/day in treatment arm
16191764|NCT01458639|Drug|Technegas V SPECT imaging|Technegas V SPECT imaging and Technetium 99m MAA Perfusion imaging for the diagnosis pf pulmonary embolism.
16191765|NCT01458639|Drug|Xenon-133 Ventilation Planar imaging|Xenon-133 Ventilation Planar imaging and Technetium 99m MAA Perfusion imaging for the diagnosis pf pulmonary embolism.
16191766|NCT01458626|Drug|mirtazapine|mirtazapine 30mg QD
16191767|NCT01458626|Drug|paroxetine 20mg QD|paroxetine 20mg QD
16191768|NCT01458600|Drug|Diclofenac|T Diclofenac 50 mg twice daily for 12 months
16191769|NCT01458600|Drug|Methimazole|T Methimazole 5 mg 3x2 for 18 months
16191770|NCT01458600|Drug|L-thyroxin|L-thyroxin approximately 100 to 200 micrograms/day. The dose is adjusted to reach euthyroidism during concomitant treatment with methimazole for 18 months
16191771|NCT01458600|Drug|Propranolol|T Propronalol 40mg 1x1-3 during during 1-3 weeks until the patient has responded to thyrostatics
16191772|NCT01458600|Drug|Metoprolol|T Metoprolol 50 mg 1x3 for 1-3 weeks until the patient has responded to thyrostatics
16191773|NCT01458587|Drug|Aminolevulinic Acid PDT (ALA)|20% ALA applied to upper extremities for 3 hours prior to 10 J/cm2 blue light
16191774|NCT01458587|Drug|Vehicle PDT (VEH)|Levulan Kerastick containing vehicle ingredients only. Vehicle solution applied to upper extremities 3 hours prior to 10 J/cm2 blue light
16191775|NCT01458574|Drug|Placebo|Placebo 10 mg orally (PO) twice a day (BID)
16191776|NCT01458574|Drug|CP690,550|CP-690,550 5 mg orally (PO) twice a day (BID)
16191777|NCT01458574|Drug|CP-690,550|CP-690,550 10 mg orally (PO) twice a day (BID)
16191778|NCT01458561|Device|BioFoam Surgical Matrix|Surgical adjunct to control bleeding in open liver surgery
16191779|NCT01458561|Device|Gelfoam Plus|Surgical adjunct in control of bleeding in open liver surgery
16191780|NCT01458548|Drug|Rituximab|Rituximab 375 mg/m2 IV on days 1, 8, 15 and 22.
16191781|NCT01458548|Drug|CHOP|Cyclophosphamide 750 mg/m2 IV, adriamycine 50 mg/m2 IV, vincristine 1.4mg/m2 IV, and prednisone 50mg/m2 PO every 3 weeks at days 50, 72, 94 and 116.
16191782|NCT01458535|Drug|ABT-450|tablets
16191783|NCT01458535|Drug|ABT-267|tablets
16191784|NCT01458535|Drug|ribavirin|tablets
16191785|NCT01458535|Drug|ritonavir|capsules
16191786|NCT01458522|Drug|fPHT|"If after initial treatment with fPHT any of the following occurs, the subject will have reached the end of the first treatment arm and will cross over and begin receiving the other drug, ie, the one not originally administered: the subject subsequently has another seizure within 24 hours following the 2-hour post-rebolus observation-only period; the subject does not receive a rebolus but has a seizure within 24 hours following the 2 hour post-bolus observation-only period; the subject experiences an AE that precludes further use of the first study drug.
~If crossover occurs, the subject will start over with the second drug, going through the same observation-only period, rebolusing (if necessary), and study assessments with the second drug, beginning with the Baseline assessments."
16191787|NCT01458522|Drug|LCM|"If after initial treatment with LCM any of the following occurs, the subject will have reached the end of the first treatment arm and will cross over and begin receiving the other drug, ie, the one not originally administered: the subject subsequently has another seizure within 24 hours following the 2-hour post-rebolus observation-only period; the subject does not receive a rebolus but has a seizure within 24 hours following the 2 hour post-bolus observation-only period; the subject experiences an AE that precludes further use of the first study drug.
~If crossover occurs, the subject will start over with the second drug, going through the same observation-only period, rebolusing (if necessary), and study assessments with the second drug, beginning with the Baseline assessments."
16191788|NCT01458509|Behavioral|surveys|IVRS: An interactive voice response system (IVRS) is an automated telephone platform. The IVRS system will allow the participant to complete the survey when they receive the call and/or to call the system within the survey window to complete the survey. In each group, administration of a survey including the BFI, PRO-CTCAE sexual function items, and QOL LASA and in each group, the survey will be conducted once a month over a six-month period. The intervention will be an email alert to study personnel (EASP). Patients randomized to EASP will receive a phone call if their bowel function by the clinical office nurse if the study personnel determine that the patient's BFI, as reported on the monthly survey, is less than 53 (lowest quartile scores). Interventions that may occur include dietary and/or medication advice at the discretion of the office staff.
16191789|NCT01458509|Behavioral|surveys|Web: Study participants will be sent an email containing a link to the web survey. The participants will click on the link and complete the survey. Study participants may also login to the web survey independent of the link received via email. In each group, administration of a survey including the BFI, PRO-CTCAE sexual function items, and QOL LASA and in each group, the survey will be conducted once a month over a six-month period. Patients randomized to EASP will receive a phone call if their bowel function by the clinical office nurse if the study personnel determine that the patient's BFI, as reported on the monthly survey, is less than 53 (lowest quartile scores). Interventions that may occur include dietary and/or medication advice at the discretion of the office staff.
16191790|NCT01458509|Behavioral|surveys|IVRS: An interactive voice response system (IVRS) is an automated telephone platform. The IVRS system will allow the participant to complete the survey when they receive the call and/or to call the system within the survey window to complete the survey. In each group, administration of a survey including the BFI, PRO-CTCAE sexual function items, and QOL LASA and in each group, the survey will be conducted once a month over a six-month period. This group will not get a phone call.
16191791|NCT01458509|Behavioral|Surveys|Web: Study participants will be sent an email containing a link to the web survey. The participants will click on the link and complete the survey. Study participants may also login to the web survey independent of the link received via email. In each group, administration of a survey including the BFI, PRO-CTCAE sexual function items, and QOL LASA and in each group, the survey will be conducted once a month over a six-month period. This group will not receive a phone call.
16191836|NCT01458236|Drug|Placebo|Placebo tablets, which are identical in size and appearance to those containing BPS-314d-MR and are for oral, BID administration, will be utilized in subjects assigned to the placebo study drug treatment group
16191837|NCT01458223|Drug|Antibiotic|Ancef or Vancomycin
16191838|NCT01458223|Drug|Antibiotic|Ancef or Vancomycin
16191839|NCT01458210|Drug|Ortho-Cyclen|Administered orally
16191792|NCT01458496|Behavioral|Health Coaching|The intervention will take approximately six months to complete. A combination of group and individual face-to-face meetings will be used. Participants will be divided into groups of 20 for group meetings. Groups will be brought together for a group coaching session at the beginning and the end of the coaching process (i.e., intervention). Each participant will also receive four individual coaching sessions with the health coach and will be able to avail of three one-hour telephone coaching sessions during the six month intervention. Participants will be encouraged to utilize telephone coaching for key support periods.
16191793|NCT01458483|Device|Baroreceptor Stimulation|The stimulation catheter may be placed in different locations within the IJV at the level of the cervical spine vertebrae. Stimulation amplitudes will be varied from 0.1 mA to 20 mA.
16191794|NCT01458470|Drug|Memantine|oral tablet, 1 BID, 24 weeks
16191795|NCT01458470|Other|Placebo|oral tablet, 1 BID, 24 weeks
16191796|NCT01458457|Other|Individualized complementary medicine treatment|An individual treatment plan will be made for each patient that includes one to all of the following treatments: acupuncture, traditional Chinese herbal medicine, enzyme therapy, nutrition advise, Healing Touch, homoeopathy, hyperthermia treatment, infusions, laser therapy, lymphatic drainage, manual therapy, mistel therapy, neural therapy, orthomolecular therapy, osteopathy, phytotherapy, shiatsu
16191797|NCT01458457|Other|Individualized usual care|Patients get usual care from their general practitioners/specialized physicians
16191798|NCT01458444|Device|Non invasive ventilation (VNI)|BIPAP® vision
16191799|NCT01458444|Device|Non invasive ventilation|OPTIFLOW system
16191800|NCT01458431|Drug|Levobupivacaine|continuous levobupivacaine subfascial infusion
16191801|NCT01458431|Drug|NaCl|continuous NaCl subfascial infusion
16191802|NCT01458418|Drug|Montelukast|Those in Montelukast 10mg/day group will receive two 5mg tablets of Montelukast.
16191803|NCT01458418|Other|placebo|Those in the placebo group will receive 2 placebo tablets per day. Those in the Montelukast 5mg/day will receive 1 placebo tablet per day.
16191804|NCT01458418|Drug|5 mg Montelukast|Subject will receive one 5mg tablet of Montelukast and one placebo tablet per day.
16191805|NCT01458405|Biological|CAP-1002 Allogeneic Cardiosphere-Derived Cells|Single dose, blinded, intracoronary infusion of 25 Million cardiosphere-derived cells
16191806|NCT01458405|Drug|Placebo|Single, blinded, intracoronary infusion of a placebo solution
16191807|NCT01458392|Biological|Dalantercept|Subcutaneous dose of dalantercept once every 3 weeks.
16191808|NCT01458366|Drug|Bendamustine|"Phase 1: Given via IV at the following dose levels:
~Level 1: 70 mg/m2
~Level -1: 50 mg/m2
~Level 2: 90 mg/m2
~Level 3: 120 mg/m2
~Phase II: Given via IV on Days 1 and 2 of each cycle at the maximum-tolerated dose level found in the Phase I portion of the study."
16191809|NCT01458366|Drug|Ofatumumab|"Phase II
~Cycle 1: 300 mg via IV on Day 1 and 1000 mg via IV on Day 3
~Cycles 2 and 3: 1000 mg via IV on Day 1"
16191810|NCT01458366|Drug|Carboplatin|Phase II: AUC 5 via IV on Day 2 of each cycle
16191811|NCT01458366|Drug|Etoposide|Phase II: 100 mg/m2 via IV on Days 1, 2, and 3 of each cycle
16191812|NCT01458366|Procedure|CT Scan|CT Scan to assess disease after Cycle 2 (approximately 25 days) and 3-8 weeks post-treatment
16191813|NCT01458366|Procedure|PET Scan|PET Scan to assess disease after Cycle 2 (approximately 25 days) and 3-8 weeks post-treatment
16191814|NCT01458366|Genetic|Stem Cell Transplant (STC)|"For potential transplant candidates:
~Autologous STC: after 2 cycles of BOCE upon discretion of Thomas Jefferson University hematopoietic stem cell transplant group and in agreement with the study PI or her designee
~Allogeneic STC: after 2 cycles of BOCE upon discretion of Thomas Jefferson University hematopoietic stem cell transplant group and in agreement with the study PI or her designee"
16191815|NCT01458353|Procedure|Stapled anastomosis|Stapled anastomosis after ileocolonic resection
16191816|NCT01458353|Procedure|Handsewn anastomosis|Handsewn anastomosis after ileocolonic resection
16191817|NCT01458340|Drug|TD-9855|Once daily
16191818|NCT01458340|Drug|TD-9855|Once daily
16191819|NCT01458340|Drug|Placebo|Once daily
16191820|NCT01458327|Drug|3,4-methylenedioxymethamphetmine (MDMA)|125 mg MDMA followed by 62.5 mg 1.5 to 2.5 hours later
16191821|NCT01458327|Behavioral|Psychotherapy|Psychotherapy in combination with MDMA
16191822|NCT01458314|Other|Daily NIV during rehabilitation|Addition of non invasive mechanical ventilation (NIV) during daily rehabilitation in patients using nocturnal NIV
16191823|NCT01458314|Other|Rehabilitation without NIV|Training in patients without NIV adoption
16191824|NCT01458301|Drug|Placebo|TAK-385 placebo-matching tablets, orally, once daily and Leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
16191825|NCT01458301|Drug|TAK-385|TAK-385 10 mg, tablets, orally, once daily and Leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks
16191826|NCT01458301|Drug|TAK-385|TAK-385 20 mg, tablets, orally, once daily and Leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks
16191827|NCT01458301|Drug|TAK-385|TAK-385 40 mg, tablets, orally, once daily and Leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks
16191828|NCT01458301|Drug|Leuprorelin acetate|TAK-385 placebo-matching tablets, orally, once daily and Leuprorelin acetate injection, subcutaneously, once every 4 weeks for up to 12 weeks
16191829|NCT01458288|Drug|TG-0054|3.14 mg/kg TG-0054 administrated via 15-min IV infusion(allow a maximum of four leukapheresis sessions)
16191830|NCT01458275|Drug|Ciclesonide nasal aerosol 37 mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37 mcg
16191831|NCT01458275|Drug|ciclesonide nasal aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
16191832|NCT01458275|Drug|Placebo|Placebo - one actuation per nostril
16191833|NCT01458262|Other|systemic and cerebral oxymetry|oxymetry measurement using near infrared spectroscopy
16191834|NCT01458249|Drug|eribulin mesylate|Administration of eribulin mesylate at a dose of 1.4 mg/m^2 as an IV bolus infusion over 2-5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days.
16191835|NCT01458236|Drug|Beraprost Sodium 314d Modified Release Tablets|Available as 15 μg and 60 μg tablets for oral, twice daily (BID) administration
16191840|NCT01458210|Biological|Dulaglutide|Administered subcutaneously
16191844|NCT01458184|Behavioral|PhoneCare system|"The aim of this study is to assess the effectiveness of Telephone-Linked Care for Complex Patients (TLC-C) in the care of patients with complex health care needs. TLC-C uses conversational computer telephony to monitor patients' multiple diseases between their ambulatory care visits. The system monitors patients through virtual visits and detects and notifies clinicians about important clinical problems to attend to. It also promotes patient self-care (e.g., medication adherence and appointment preparation)."
16191845|NCT01458171|Biological|Immune globulin subcutaneous (Human)|IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human immunoglobulin for subcutaneous (SC) use. Subjects will receive weekly infusions of IgPro20 for a total of 24 weeks at a dose based on the subject's IgPro20 dose in the pivotal study ZLB06_002CR (NCT01199705).
16191846|NCT01458145|Behavioral|Minding the Baby Home Visiting Program|Weekly home visits for one year followed by bi-weekly home visits until child is 24 months of age provided to young at risk families by a team of nurse practitioner and social worker home visitors
16191847|NCT01458119|Drug|migalastat hydrochloride|Oral capsule QOD
16191848|NCT01458106|Drug|BIIB031 (rFVIIIFc)|Vials of rFVIIIFc were combined as needed, based on the actual labeled potency to achieve the participant's calculated dose. Partial vial use was allowed, in order to achieve the calculated dose.
16191849|NCT01458106|Drug|FVIII (PK subgroup only)|Baseline prestudy FVIII dosing in participants who enter the PK subgroup. Vials of prestudy FVIII were combined as needed, based on the nominal labeled potency (e.g., 250 IU, 500 IU, and 1000 IU), to achieve the participant's calculated dose.
16191850|NCT01458093|Other|colonoscopy|evaluation of surveillance timing adequacy as compared to the guidelines
16191851|NCT01458080|Drug|eltrombopag|eltrombopag
16191852|NCT01458067|Drug|GSK2636771|Oral capsules
16191853|NCT01458054|Drug|Cohort 1 (GSK2336805 60mg x 1 dose, Omeprazole 40 mg q24h x 4 days, GSK2336805 60 mg x 1 dose and Omeprazole 40 mg x 1 dose)|GSK2336805 and Omeprazole
16191854|NCT01458054|Drug|Cohort 2 (GSK2336805 30mg x 1 dose, Ritonavir 100mg q12h x 4 days, and Ritonavir 100mg q12h x 1 dose)|GSK2336805 and Ritonavir
16191855|NCT01458041|Drug|Iloprost (Ilomedin, BAYQ6256)|Prescription and treatment of Iloprost will be decided by physicians
16191856|NCT01458028|Drug|BAY85-3934|Single doses of 20 mg BAY85-3934 as tablet
16191857|NCT01458028|Drug|Placebo|Single dose of placebo tablet matching the 20 mg BAY85-3934 tablet
16191858|NCT01458015|Drug|tapentadol, oxycodone|tapentadol pr 100-500 mg oxycodone cr 20-120mg
16191859|NCT01458002|Other|Tailored Internet Communication with Relational Agent|"The Tailored Internet Intervention will include a relational agent component, which is an animated conversational agent that builds a working relationship with subjects over time and uses this alliance to boost intervention effectiveness and retention to the Tailored Internet Communications web site."
16191860|NCT01458002|Other|Tailored Internet Communications|Best practices for TTM tailored communications with two types of feedback: normative - compared to peers and ipsative - self compared to previous assessment.
16191861|NCT01457989|Drug|retigabine/ezogabine|dose range up to 1200 mg/day
16191862|NCT01457950|Drug|denosumab|double-blind phase: 60mg subcutaneous injection, single dose
16191863|NCT01457950|Drug|placebo|double-blind phase: placebo subcutaneous injection, single dose
16191864|NCT01457950|Drug|open-label denosumab|open-label phase: 60mg subcutaneous injection, single dose
16191865|NCT01457937|Drug|Pegylated Interferon, Ribavirin, Boceprevir|"PEG IFN alfa 2b 1,5 ug/kg once weekly; Ribavirin (800-1400 mg / day)
~or
~PEG IFN alfa 2b 1,5 ug/kg once weekly; Ribavirin (800-1400 mg / day); Boceprevir (1.5 mcg / kg QW)"
16191866|NCT01457924|Drug|Ofatumumab 3mg|3mg of investigational product
16191867|NCT01457924|Drug|Ofatumumab 30mg|30mg of investigational product
16191868|NCT01457924|Drug|Ofatumumab 60mg|60mg of investigational product
16191869|NCT01457924|Drug|Placebo|Placebo
16191870|NCT01457911|Drug|Glimepiride and Metformin hydrochloride combination (HOE490)|Pharmaceutical form:tablet Route of administration: oral
16191871|NCT01457911|Drug|Glimepiride (HOE490)|Pharmaceutical form:tablet Route of administration: oral
16191872|NCT01457898|Device|VPAP II®|VPAP group:inspiratory pressure to generate 6ml/kg of weight and expiratory pressure of 7cmH2O plus oxygen therapy (FIO2=40%) during three hours.
16191873|NCT01457885|Drug|Clofarabine/Busulfan x 4|"Clofarabine IV dose level: 40 mg/m2/day x 5 days
~Busulfan IV dose level: 3.2 mg/kg daily x 4 days"
16191874|NCT01457885|Procedure|Peripheral blood stem cell transplant|Peripheral blood stem cell transplant, after pre-conditioning drug treatment
16191875|NCT01457872|Behavioral|Strength-based case management|Strength-based case management
16191876|NCT01457872|Behavioral|Control condition - referral only|Referral only
16191877|NCT01457859|Drug|Triclosan|Triclosan coated surgical sewing threads (VICRYL+ and MONOCRYL+) applied for leg wound closure after CABG
16191878|NCT01457859|Other|Conventional non-coated surgical sutures|Conventional non-coated surgical sewing threads (POLYSORB and BIOSYN) will be applied after CABG for leg wound closure
16191879|NCT01457846|Drug|AZD4547|Tablets taken, oral, twice daily, commencing with a 2 week on AZD4547, 1 week off AZD4547 schedule.
16191880|NCT01457846|Drug|paclitaxel|Infusion administered once a week, 3 weeks on and 1 week off
16191881|NCT01457833|Device|EBV implantation|In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. The most advanced technique is the implantation of valves. The one-way mechanism of these valves allows air to be expelled during exspiration without any influx of air during inspiration.
16191935|NCT01457482|Other|Art Therapy and therapeutic conversations|Treatment consists of five sessions of Art Therapy given by an authorised Art Therapist and therapeutic conversations with specialist midwives. Number of conversations is determined by the participant.
16191936|NCT01457482|Other|Therapeutic conversations|Therapeutic conversations with specialist midwives. Number of conversations is determined by the participant.
16191937|NCT01457469|Other|questionnaire administration|Ancillary studies
16191938|NCT01457469|Procedure|quality-of-life assessment|Ancillary studies
16191882|NCT01457833|Device|IBV implantation|In severe cases of COPD even optimum treatment involving bronchodilatation with drugs, physical training and possibly oxygen therapy is unable to influence exercise capacity and the perception of dyspnoea to a sufficient extent. Given the assumption that the elastic recoil of the small airways can be improved by a reduction in lung volume and pulmonary function overall by more ergonomic breathing mechanics and diaphragm function, various endoscopic procedures for lung volume reduction are available. The most advanced technique is the implantation of valves. The one-way mechanism of these valves allows air to be expelled during exspiration without any influx of air during inspiration.
16191883|NCT01457820|Drug|Allopurinol|Stat dose Allopurinol 800mg, then 400mg BD for 5 days
16191884|NCT01457820|Drug|Allopurinol|Stat dose Allopurinol 400mg, then 300mg BD for 5 days
16191885|NCT01457820|Drug|Placebo|Matched placebo, stat dose, then 5 days of matched placebo BD.
16191886|NCT01457807|Drug|AZD3241 ER formulation 1|Oral tablets, 100mg bd on Day 1 to Day 2, 200mg bd on Day3, 300mg bd on Day 4 to Day7 and 300mg Once daily on Day 8 with High Fat Breakfast
16191887|NCT01457807|Drug|Placebo|Placebo will be administered with the same intervention scheme as intervention 1 and 2
16191888|NCT01457807|Drug|AZD3241 Alternative titration scheme with formulation 1 or 2|50 mg oral dose bd on Day 1, 100 mg oral dose bd on Day 2 and 3, 200 mg oral dose bd on Day 4, 300 mg oral dose bd on Day 5 to 7 and 300 mg once in the morning on Day 8
16191889|NCT01457794|Other|School meals based on the principles of the New Nordic Diet|The study participants are provided with three daily school meals for 3 month
16191890|NCT01457781|Drug|Nitric Oxide|0.025 mg/kg IBW/hr for up to 24 hours/day x 16 weeks (3.0 mg/L [2440 ppm] NO mini-cylinder; change q 24 hours)
16191891|NCT01457781|Other|Placebo|Placebo 0.075 mg/kg IBW/hr for up to 24 hours/day x 16 weeks (Nitrogen N2, 99.999%)
16191892|NCT01457781|Drug|Nitric Oxide|Cohort 2: 0.075 mg/kg IBW/hr for up to 24 hours/day x 16 weeks (3.0 mg/L [2440 ppm] NO mini-cylinder; change q 24 hours)
16191893|NCT01457742|Device|Ivivi SofPulse|15 minute Pulsed Radio Frequency (PRF) treatment twice per day
16191894|NCT01457742|Device|Ivivi SofPulse|15 minute simulated treatment using Sham Device twice per day
16191895|NCT01457729|Behavioral|Motivation by Telephone Call|Telephone call not exceeding 10 minutes according to a protocol
16191896|NCT01457716|Drug|Budesonide|Single inhalation
16191897|NCT01457716|Drug|Formoterol|Single inhalation
16191898|NCT01457716|Device|Easyhaler|Inhaler device
16191899|NCT01457716|Device|Turbohaler Forte|Inhaler device
16191900|NCT01457703|Drug|Cetrorelix|Abolishes pituitary sensitivity to GnRH.
16191901|NCT01457703|Drug|Gonadorelin-GnRH|GnRH is used to stimulate the pituitary gland to produce LH and FSH.
16191902|NCT01457703|Drug|Recombinant LH|Used to stimulate ovarian function in women.
16191903|NCT01457703|Drug|Letrozole|An aromatase inhibitor.
16191904|NCT01457690|Drug|Tocofersolan|Administration of a daily dose of vitamin E for 4 months:50 IU/kg
16191905|NCT01457690|Drug|tocopherol alpha|Administration of a daily dose of vitamin E for 4 months:50 IU/kg
16191906|NCT01457690|Drug|Tocofersolan and tocopherol alpha|Administration of a single dose of vitamin E (Vitamin E water-soluble then Vitamin E conventional fat-soluble form)
16191907|NCT01457677|Drug|Placebo|matching placebo to RO4995819 oral once daily for 6 weeks
16191908|NCT01457677|Drug|RO4995819|5 mg oral once daily for 6 weeks
16191909|NCT01457677|Drug|RO4995819|15 mg oral once daily for 6 weeks
16191910|NCT01457677|Drug|RO4995819|30 mg oral once daily for 6 weeks
16191911|NCT01457664|Drug|Placebo|Placebo to RO4995819 once daily for 14 days
16191912|NCT01457664|Drug|RO4995819|RO4995819 doses once daily for 14 days
16191913|NCT01457651|Procedure|Alveolar recruitment|"Four approaches:
~CPAP 40 cm H2O
~Peak pressure 40 cm H2O
~PEEP 15 cm H2O for 300 sec
~no intervention (controls)"
16191914|NCT01457638|Procedure|Inferior turbinate surgery|During rhinoseptoplasty inferior turbinate submucosal cauterization is performed.
16191915|NCT01457638|Procedure|No iInferior turbinate surgery|During rhinoseptoplasty no intervention is done in inferior turbinates
16191916|NCT01457612|Dietary Supplement|Strawberry|20g twice per day (BID) in beverage
16191917|NCT01457612|Dietary Supplement|Placebo1|Placebo Beverage 1 without fiber
16191918|NCT01457612|Dietary Supplement|Placebo2|Placebo Beverage 2 with Fiber
16191919|NCT01457599|Procedure|Computertomography-guided marking of colorectal liver metastases|Computertomography-guided marking of colorectal liver metastases
16191920|NCT01457586|Biological|Blood transfusion|Blood transfusion in perioperative period.
16191921|NCT01457586|Biological|No blood transfusion|No transfusion in the perioperative period.
16191922|NCT01457573|Drug|Tamsulosin|Alpha blocker used to in the treatment of urinary difficulties related to enlarged prostate or symptomatic benign prostatic hypertrophy. All men will receive Tamsulosin (Flomax®) 0.4 mg, 1 tab, per morning with Solifenacin (Vesicare®).
16191923|NCT01457573|Drug|Solifenacin|Antispasmodic/anticholinergic used to treat overactive bladder. All men will receive Solifenacin (Vesicare®) 5 mg, 1 tab, per morning with Tamsulosin.
16191924|NCT01457560|Biological|DTPa-HBV-IPV/Hib (Infanrix hexa™)|Three doses administered intramuscularly
16191925|NCT01457560|Biological|OPV|One dose administered orally
16191926|NCT01457547|Biological|DTPa-HBV-IPV/Hib Vaccine (INFANRIX™ HEXA)|Three doses administered intramuscularly
16191927|NCT01457547|Biological|DTPa-HBV-IPV-Hib vaccine (HEXAVAC™)|Three doses administered intramuscularly
16191928|NCT01457521|Drug|Ibuprofen|Ibuprofen
16191929|NCT01457508|Biological|DTPa-HBV-IPV/Hib (Infanrix hexa™)|Three doses administered intramuscularly
16191930|NCT01457508|Biological|DTPa-HBV-IPV (Infanrix penta™)|Three doses administered intramuscularly
16191931|NCT01457508|Biological|Hib (Hiberix™)|Three doses administered intramuscularly
16191932|NCT01457495|Biological|DTPa-HBV-IPV/Hib (Infanrix-hexa™)|3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8
16191933|NCT01457495|Biological|DTPa-IPV/Hib (Infanrix-IPV/Hib™)|3 doses administered intramuscularly into the right thigh at study month 0, 2 and 8
16191934|NCT01457495|Biological|HBV (Engerix™-B)|3 doses administered intramuscularly into the left thigh at study month 0, 2 and 8
16191939|NCT01457469|Other|counseling intervention|Undergo counseling session
16191940|NCT01457469|Other|internet-based intervention|Receive enhanced quitline intervention
16191941|NCT01457469|Behavioral|telephone-based intervention|Receive enhanced quitline intervention
16191942|NCT01457469|Other|educational intervention|Receive usual care plus
16191943|NCT01457469|Drug|nicotine replacement therapy|Receive nicotine replacement patches
16191944|NCT01457469|Other|educational intervention|Receive enhanced quitline intervention
16191945|NCT01457430|Drug|Icatibant|30 mg subcutaneous dose of Icatibant
16191946|NCT01457417|Drug|DKN-01|DKN-01 will be administered intravenously (IV) once a week over 30 minutes (min) and 2 hours (max) for 75, 150 and 300 mg. At 600 mg, DKN-01 will be administered by IV on days 1 and 15 of each cycle. PART A - Dose Escalation: 3 participants will be treated with a 28 day cycle of DKN-01 at an assigned dose level until disease progression. Dose escalation will occur sequentially over the doses of 75, 150, 300, and 600 mg until the criteria for reaching maximum tolerated dose (MTD) are met (or highest planned dose study group is completed). Cycle 1 will define the dose limiting toxicity (DLT) that governs dose escalation. PART B - Dose Confirmation: Once the MTD is established (or the highest planned dose level), 300 mg of DKN-01 will be administered IV on days 1 and 15 of every 28 day cycle.
16191947|NCT01457404|Behavioral|Integrated Cognitive Behavioral Therapy|Individual or group ICBT, approx. 12 sessions, one session per week
16191948|NCT01457404|Behavioral|Treatment-as-usual|Individual or group therapy as usual within the SATP or PTSD clinics at the PVAMC
16191949|NCT01457391|Behavioral|Cognitive Behavioral Therapy|Individual CBT, approx. 12 sessions, one session per week
16191950|NCT01457391|Behavioral|Individual Addiction Counseling|Individual therapy, approx. 12 sessions, one session per week
16191951|NCT01457391|Behavioral|Treatment-as-usual|Individual or group therapy, approx. 9-12 hours per week, multiple times a week for 2 months
16191952|NCT01457352|Drug|SPARC0921|
16191953|NCT01457352|Drug|Placebo0921|
16191954|NCT01457339|Drug|SPD489 (Lisdexamfetamine dimesylate)|SPD489 administered orally in ascending doses (50mg, 70mg, 100mg, 150mg, 200mg, 250mg). Each of these doses will be administered once daily for 5 days. Total number of days dosed is 30 days.
16191955|NCT01457339|Drug|Placebo|Placebo Capsule(s) for oral use taken once daily for 30 days
16191956|NCT01457300|Other|Rehabilitation|Model 1: Regular Assessment of Rehabilitation Goal, Rehabilitation Plan, Weekly Multi-Disciplinary Evaluation and Adjustment of Plan, Regular use of Measurement Scales, Regular Dialog between Personnel, Patient and Relatives. Model 2: More Occasional use of the Listed Activities. Model 1 and Model 2: Physical Training and Functional ADL Training, in Groups, One by One or Self-Training.
16191957|NCT01457274|Other|Sedation depth|"The intervention is the depth of sedation targeted in this study.
~Patients enrolled in this study will be sedated with the same medications (fentanyl bolus and propofol target controlled infusion), and at the same starting doses, in each study arm. However, the depth of sedation targeted will differ between the arms, and this depth will be guided by the BIS monitor.
~It is expected that those patients randomised to deep sedation will require a higher dose of sedative medication to achieve their target BIS value (<60) than those in the light sedation group (BIS 70-80)."
16191958|NCT01457261|Drug|Salbutamol|Radiolabelled salbutamol to be administered as a monodisperse particle via a spinning top aerosol generator or else as a polydisperse mist via a nebuliser or metered dose inhaler.
16191959|NCT01457248|Device|Endotracheal tube TaperGuard|Patients are intubated by endotracheal tube with taper-shaped cuff (TaperGuard, Mallinckrodt)
16191960|NCT01457248|Device|Endotracheal tube Hi-Contour Brandt|Patients are intubated by endotracheal tube with cylindrical-shaped cuff (Hi-Contour Brandt, Mallinckrodt)
16191961|NCT01457235|Other|Cognitive Remediation|All subjects will complete an MR brain scan, blood test, saliva test, and a neuropsychological battery of manual and computerised tests at baseline, at week 12 (end of active treatment) and week 26 (follow-up). Subjects randomly allocated to an active group will participate in a 12-week group-based cognitive remediation programme once a week for two hours. The waiting list group continues treatment as usual.
16191962|NCT01457222|Behavioral|Mindfulness intervention|Web-based guided mindfulness meditation 10 minutes daily
16191963|NCT01457222|Behavioral|Music relaxation|Music relaxation 10 minutes daily
16191964|NCT01457209|Other|Acupuncture|"Needle placement in abdominal muscles, in m. vastus lateralis, lower leg and hands.
~Stimulation: Manual rotation of the needles and electrical stimulation of the needles in the abdominal muscles and m. vastus lateralis will be stimulated electrically with low burst frequency Duration: 30 min Treatment: 3 times/wk during 5 weeks."
16191965|NCT01457196|Diagnostic Test|Tumor Genetic Sequencing|This study will look at genetic material from a sample of the subjects tumor, look at certain changes in the genetic material, and see if these changes are related to the subjects cancer.
16191966|NCT01457183|Device|Pulsed lavage (Stryker Pulsavac Plus)|Healthy subjects with intact skin will be lavaged through the device for 1 minute on 3 different sites. The stryker pulsavac plus will be used for the lavage.
16191967|NCT01457170|Drug|Apelin|During right heart catheterisation, Apelin will be infused at 30, 100 and 300 nanomol/min for 5 minutes. Apelin will then be infused at 300 nanomol/min for a further 15 minutes while the subject exercises using a supine ergometer.
16191968|NCT01457170|Drug|Saline (Placebo)|During right heart catheterisation, saline will be infused for 15 minutes while the subject rest and for a further 15 minutes while the subject exercises using a supine ergometer.
16191969|NCT01457170|Drug|Saline (Placebo)|During right heart catheterisation, saline will be infused for 15 minutes while the subject rest and for a further 15 minutes while the subject exercises using a supine ergometer.
16191970|NCT01457170|Drug|Apelin|During right heart catheterisation, Apelin will be infused at 30, 100 and 300 nanomol/min for 5 minutes. Apelin will then be infused at 300 nanomol/min for a further 15 minutes while the subject exercises using a supine ergometer.
16191971|NCT01457144|Drug|RiBVD|"Every cycle:
~Rituximab intravenous infusion dosage 375 mg/m² day 1 Bendamustine direct intervenous 90 mg/m² day 1 and day 2 Velcade®subcutaneous 1,3 mg/m² day 1,4, 8 and 11 dexamethasone 40 mg IVD on day 2"
16191972|NCT01457131|Drug|Fludarabine|50 mg/m2, IV(in the vein)on day 5 of each 25 day cycle
16191973|NCT01457131|Drug|Cyclophosphamide|60 mg/kg/day X 2 days IV in 250 ml D5W with mesna 15 mg/kg/day X 2 days
16191974|NCT01457131|Other|IL-12 &amp; Anti-NY ESO1 TCR PBL|10(7) cells to 3 X 10(10) cells
16192187|NCT01455467|Device|One iStent|Implantation of one iStent in conjunction with cataract surgery
16191975|NCT01457118|Drug|NKTR-102 145 mg/m2|A 90 minute IV infusion of 145 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.
16191976|NCT01457118|Drug|NKTR-102 120 mg/m2|A 90 minute IV infusion of 120 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.
16191977|NCT01457118|Drug|NKTR-102 95 mg/m2|A 90 minute IV infusion of 95 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.
16191978|NCT01457118|Drug|NKTR-102 50 mg/m2|A 90 minute IV infusion of 50 mg/m2 or less of NKTR-102 on Day 1 of each 21-day treatment cycle.
16191979|NCT01457105|Device|Endoscopic retrograde cholangiography (ERC) (ComVi biliary stent)|Metal stents placement in the main biliary duct during ERC
16191980|NCT01457092|Device|FC Nitinol SEMS (Niti-S, TaeWoong Medical Co., Korea)|Placement of self-expandable metal stents
16191981|NCT01457066|Behavioral|Peer Navigator Intervention|Peer navigators will teach HIV retention and linkage skills and knowledge using group-based as well as one-on-one, peer-based learning approaches.
16191982|NCT01457053|Drug|Loop diuretics (furosemide, torsemide, bumetanide)|"Patients with ADHF and hypervolemia will be enrolled in a prospective, randomized fashion.
~Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization for the management of fluid overload.
~Patients randomized to diuretic therapy will be treated with intravenous loop diuretics (e.g. furosemide, bumetanide, torsemide). The selection of diuretic, dose and frequency of diuretic administration will be determined by the treating physicians based upon clinical assessment of volume status, response to medication, and perceived safety."
16191983|NCT01457053|Other|Ultrafiltration|"Subjects will be randomized with a computer generated random number function to either ultrafiltration or diuretic therapy within 24 hours of hospitalization or outpatient heart failure clinic for the management of fluid overload. If randomized to the ultrafiltration arm, on admission to the hospital patients will be initiated on ultrafiltration therapy for 2-5 days.
~Patients randomized to UF will be treated using the Aquadex System 100 ultrafiltration device (CHF Solutions, Minneapolis, MN). The selection of ultrafiltration rate (fluid removal rate)will be determined by the treating physicians based upon clinical assessment of volume status and perceived safety."
16191984|NCT01457040|Drug|TBI+CY+VP-16|CR Cohort will receive conditioning regimen of TBI+CY+VP-16: TBI: 4.5Gy/d, -5d, -4d; CY: 60mg/kg/d, -3d, -2d; VP-16: 15mg/kg/d, -3d, -2d
16191985|NCT01457040|Drug|FA+TBI+CY+VP-16|NR Cohort will receive conditioning regimen of FA+TBI+CY+VP-16: Flu: 35mg/m2/d: -10~-6d; AraC: 1g/m2/d, -10d~-6d; TBI: 4.5Gy/d, -5d,-4d; CY:60mg/kg/d, -3d, -2d; VP-16: 15mg/kg, -3d, -2d
16191986|NCT01457027|Biological|Inflexal V|"Inflexal V influenza vaccine, formulated for the WHO requirements ofr the 2011-2012 season, containing per 0.5 mL dose:
~15 µg hemagglutinin (HA) antigen of A/California/7/2009 (H1N1)-like virus
~15 µg HA antigen of A/Perth/16/2009 (H3N2)-like virus
~15 µg HA antigen of B/Brisbane/60/2008-like virus
~Dose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Day 1"
16191987|NCT01457014|Device|servo ventilation auto|Expiratory pressure automatically adjusted to stabilize the upper airway. Inspiratory pressure automatically adjusted to deliver consistent peak flow.
16191988|NCT01457014|Device|Continuous positive airway pressure|continuous positive airway pressure
16191989|NCT01457014|Device|servo ventilation manual|servo ventilation titrated in manual mode
16191990|NCT01457001|Drug|25-OH-D vitamin|
16191991|NCT01456975|Procedure|Aortic valve reimplantation using Valsalva prosthesis|Aortic valve reimplantation (David procedure)using Valsalva prosthesis
16191992|NCT01456949|Device|Medtronic Arctic Front® Cardiac CryoAblation System|Cardiac cryoablation to isolate the pulmonary veins using the Arctic Front® CryoAblation System, with point ablation using the Freezor® Max as needed.
16191993|NCT01456936|Drug|Placebo|Triple dummy placebo for each treatment arm
16191994|NCT01456936|Drug|varenicline tartrate|Subjects will be titrated to the full dose during the first week in the following manner: 0.5 mg (tablet form) once a day for 3 days, 0.5 mg twice a day for 4 days, then 1 mg twice a day for 11 weeks
16191995|NCT01456936|Drug|bupropion hydrochloride|Subjects will receive 150 mg (tablet form) once a day for 3 days and then will take 150 mg twice a day for the remainder of the treatment period (11 weeks and 4 days).
16191996|NCT01456936|Drug|Nicotine Replacement Therapy Patch|Subjects will start active dosing the morning of the Week 1 visit and will receive a 21 mg transdermal patch per day x 7 weeks, followed by a 14 mg transdermal patch per day x 2 weeks, and then a 7 mg transdermal patch x 2 weeks for a total of 11 weeks of treatment.
16191997|NCT01456923|Other|Treatment with chemotherapy|
16191998|NCT01456923|Other|Only chemotherapy treatment for study cohort|Control patients were treated both with surgery and chemotherapy. Study patients were treated only with chemotherapy
16191999|NCT01456923|Procedure|surgery|
16192000|NCT01456910|Behavioral|Resistance Training Program|Frequency, volume, repetitions, load, interval
16192001|NCT01456897|Drug|OPC-34712|orally administered once daily
16192002|NCT01456884|Behavioral|Live guitar and vocal music therapy|Live guitar and vocal music therapy. Subject is passive recipient for 30 minutes.
16192003|NCT01456884|Behavioral|Vibroacoustic Music Therapy|30 minutes using vibroacoustic mat.
16192004|NCT01456871|Procedure|Guided insertion of electrodes|Fine-wire needle electrodes (30mm x 27gauge needle with a pairs of 0.051mm, insulated, hooked wires, Motion Lab Systems, Baton Rouge, LA) guided by sonographic evaluation of the pulley system using a Philips iU22 Ultrasound Machine (Philips Ultrasound Systems, Bothell, WA), a 17-5 MHz linear array transducer, and standard ultrasound gel.
16192005|NCT01456871|Procedure|Electromyographic (EMG) recording|EMG signal recording, performed with an MA 300 EMG system (Motion Lab Systems, Baton Rouge, LA).
16192006|NCT01456858|Other|Insecticide Treated Polyethylene Sheeting|Insecticide Treated Polyethylene Sheeting is based on the standard polyethylene sheeting that is issued routinely as temporary shelter for people affected by emergencies. During manufacture the pyrethroid insecticide, deltamethrin, is extruded with the polyethylene into three-ply laminated sheets, comprising an inner low-density laminate and two, outer high-density laminates. The insecticide release characteristics enable the deltamethrin to diffuse slowly to the outer surfaces and to become available for pick-up by any insect that lands on the surface.
16192007|NCT01456858|Other|Untreated Plastic Sheeting|Standard polyethylene sheeting that is issued routinely as temporary shelter for people affected by emergencies. Standard untreated plastic sheeting is Identical to ITPS but without the incorporation of insecticide.
16192008|NCT01456819|Biological|Mononuclear and mesenchymal stem cells|Intramuscular administration into the ischemic limb
16192009|NCT01456819|Biological|Mononuclear cells|Intramuscular administration into the ischemic limb
16192010|NCT01456806|Other|Education|Structured group education programmes were delivered to provider and/or people with type 2 diabetes by trained professionals; identical system interventions were applied to all four groups.
16192011|NCT01456793|Behavioral|Teen Options to Prevent Pregnancy (T.O.P.P.)|Telephone-based care coordination and mobile contraceptive services
16192012|NCT01456780|Drug|Loteprednol/tobramycin|Zylet (loteprednol/tobramycin) drops, 1 drop twice a day for 4 weeks.
16192013|NCT01456780|Drug|Loteprednol|Eye drops, 1 drop twice a day for 4 weeks
16192014|NCT01456780|Drug|B+L Advanced Eye Relief Lubricant Drop|Bausch + Lomb (B+L) Advanced Eye Relief Lubricant Drop (Artificial Tears), 1 drop twice a day for 4 weeks.
16192015|NCT01456767|Dietary Supplement|Probiotics|"Bacterial supplements (Lactobacillus plantarum WCFS1, Lactobacillus plantarum CIP104448, and Lactobacillus plantarum CIP104450) will be prepared in the food-grade pilot plant of NIZO food research. Exactly 1x10^11 life bacteria are consumed by each participant.
~Consumption of this amount of life bacteria is in line with earlier human studies and routinely reached by the consumption of dairy. As a placebo, the same drink will be used without addition of bacterial cells."
16192016|NCT01456754|Dietary Supplement|low feeding frequency (3x)|3 meals a day
16192017|NCT01456754|Dietary Supplement|High feeding frequency (14x)|14 meals a day
16192018|NCT01456741|Procedure|EBNA with ROSE|"The patients in this arm will undergo:
~A) bronchoscopy, endobronchial needle aspiration (EBNA) with a cytologic needle (21 gauge), at least three forceps biopsies, bronchial brushing and bronchial washing in this procedural sequence with rapid on-site evaluation
~B) if A will be negative transthoracic needle aspiration or surgical biopsy will be performed
~C) if A and B will be negative follow-up with computed tomography or positron emission tomography and computed tomography"
16192019|NCT01456741|Procedure|standard EBNA|"The patients in this arm will undergo:
~A) bronchoscopy, endobronchial needle aspiration (EBNA) with a cytologic needle (21 gauge), at least three forceps biopsies, bronchial brushing and bronchial washing in this procedural sequence.
~B)if A will be negative transthoracic needle aspiration or surgical biopsy will be performed
~C) if A and B will be negative follow-up with computed tomography or positron emission tomography and computed tomography"
16192020|NCT01456728|Dietary Supplement|Progastria|"All subjects will receive 2 x 20 mg omeprazole per day for 28 days.
~L. reuteri ProGastria will be delivered at a dose of 1x108 CFU of 2 strains of L. reuteri giving a final dose of L. reuteri of 2x108 CFU. One chewable tablet is to be taken once per day giving a dose of L. reuteri of 2x108 CFU/day. This dose of L. reuteri has been shown to be effective in a series of conditions earlier, including inhibition of H. pylori in humans, and is considered the optimal dose. The study products will be taken daily for 28 consecutive days."
16192021|NCT01456728|Dietary Supplement|Placebo|The placebo will have identical in appearance and taste with the active study product only lacking the bacteria. It will be prescribed the same way as ProGastria: omeprazole 2x20mg and Placebo 1 tablet per day for 28 consecutive days
16192022|NCT01456715|Biological|Gardasil vaccine, Immunogenicity, Booster dose.|Gardasil vaccine given according to the 0,6 months schedule and a booster dose of Gardasil given 42 months later.
16192023|NCT01456715|Biological|Cervarix Vaccine, Immunogenicity, Booster Dose.|Gardasil vaccine given according to the 0,6 months schedule and a booster dose of Cervarix given 42 months later.
16192024|NCT01456702|Procedure|risk stratification group|goal-directed volume therapy due to svv measurement or volume therapy via standard operated procedures in dependence of cardiac risk factores
16192025|NCT01456689|Drug|LGH447|
16192026|NCT01456689|Drug|midazolam|
16192027|NCT01456676|Drug|Nilotinib + LDE225|Nilotinib is an aminopyrimidine ATP-competitive inhibitor of the protein tyrosine kinaseactivity of BCR-ABL.
16192028|NCT01456663|Drug|AFQ056|
16192029|NCT01456650|Drug|Glyburide|"Patients in which the fasting glucose persisted above the treatment goal ( fasting plasma glucose above 126 mg/dl) will receive glyburide. The dose of the medication will be adjusted based on the result of blood glucose using the following table:
~Fasting glucose 126 to 140 mg/dl: 2.5 mg/day (half tablet in the morning) 141 to 180 mg/dl: 5 mg/day (a tablet in the morning) 181 220 mg/dl: 7.5 mg/day (a tablet in the morning and half tablet per night) 221 to 250 mg/dl: 10 mg/day (a tablet in the morning) and a tablet in the evening."
16192030|NCT01456637|Behavioral|CBT for insomnia|The techniques used throughout the self-help manual are all effective in reducing insomnia: 1) Stimulus control: patients should only go to bed when sleepy, use the bed and bedroom for sleep (and sex) only, maintain a regular rising time, avoid daytime naps and get out of bed and go into another room when unable to fall asleep within 15-20 minutes (return only when sleepy). 2) progressive muscle relaxation. 3) sleep hygiene education (improving health and environmental factors that affect sleep). 3). Sleep restriction, whereby participants will stay only the time in bed that they sleep. 4) cognitive therapy to challenge and dispute incorrect and unhelpful thoughts about sleep (e.g. I must sleep at least 8 hours, otherwise I'll be a wreck tomorrow).
16192031|NCT01456624|Drug|Megace|800mg
16192032|NCT01456624|Drug|DW-ES(B)|625mg
16192033|NCT01456611|Drug|Diclofenac|Diclofenac Sodium Gel 1%
16192034|NCT01456611|Drug|Placebo|Placebo Topical Gel
16192035|NCT01456598|Procedure|Laparoscopic gastrectomy|"After laparoscopic observation, the possibility of surgery can be considered by examining inside of abdomen.
~The surgeon undergoes laparoscopic subtotal gastrectomy and D2 lymph node dissection
~After lymph node dissection, it is possible to undergo gastrectomy on appropriate part and reconstruction under small incision or laparoscopic view.
~As the reconstruction, one of the techniques like Billroth I, Billroth II and Roux en Y and so on is applied and there is no limitation on use of appliance."
16192036|NCT01456598|Procedure|Open gastrectomy|"After laparotomy, the possibility of surgery can be considered by examining inside of abdomen.
~The surgeon undergoes open subtotal gastrectomy and D2 lymph node dissection
~After lymph node dissection, one of the techniques likes Billroth I, Billroth II and Roux en Y and so on is applied and there is no limitation on use of appliance."
16192037|NCT01456585|Other|Gemcitabine|
16192038|NCT01456585|Drug|CP-870,893|
16192039|NCT01456572|Dietary Supplement|ensure plus|17 % protein, 30 % fat and 53 % carbohydrate; 1 kcal/mL
16192188|NCT01455467|Device|Two iStent|Implantation of two iStent in conjunction with cataract surgery
16192040|NCT01456572|Dietary Supplement|standardized test meal|scrambled eggs, two slices of whole wheat bread, 200 mL of milk and labeled with 13C-octanoic acid
16192041|NCT01456559|Other|Lower body negative pressure (LBNP)|"The purpose with the planned study is to study pleth variability index (PVI) as a non invasive indicator for mild hypovolemia during spontaneous breathing in healthy subjects. Lower body negative pressure (LBNP), a well established technique, is used to create defined levels of hypovolemia.
~Baseline data are recorded with the subjects in the supine position breathing with normal tidal volume without PEEP and without LBNP applied. Data are then recorded with LBNP applied in two steps (40 and 15 mmHg). Recordings are continued 5 minutes after releasing the negative pressure. Data are collected in total in four different series; normal tidal volume without PEEP; normal tidal volume with PEEP 5cm H2O; three doubled tidal volume without PEEP; three doubled tidal volume with PEEP 5 cm H20."
16192042|NCT01456546|Drug|Proguanil|2x350 mg Malarone followed by 3 days of blood- and urine sampling
16192043|NCT01456546|Drug|Clopidogrel|2x300 mg Plavix followed by 7 hours days of blood sampling
16192044|NCT01456520|Drug|Vycavert|single dose Vycavert containing 10 mg hydrocodone bitartrate/325 mg acetaminophen
16192045|NCT01456520|Drug|Norco|single dose Norco containing 10 mg hydrocodone bitartrate/325 mg acetaminophen
16192046|NCT01456507|Drug|ALO-02 (Oxycodone Naltrexone)|single dose of ALO-02 capsule under fasting condition
16192047|NCT01456507|Drug|ALO-02 (Oxycodone Naltrexone)|single dose of ALO-02 capsule under fed condition
16192048|NCT01456507|Drug|ALO-02 (Oxycodone Naltrexone)|ALO-02 with the ALO-02 pellets sprinkled on applesauce, and administered under fasting conditions.
16192049|NCT01456494|Other|Brief Intervention|A brief educational strategy that employs verbal and written instructions, without demonstration or repeated rounds of instruction, to teach patients how to use their inhalers.
16192050|NCT01456494|Other|Teach-to-Goal Education|Teach-to-goal (TTG) is a method of patient instruction that employs repeated rounds of teaching (demonstration, verbal, written instructions) and assessments (teach-back) of patient comprehension.
16192051|NCT01456481|Drug|midodrine hydrochloride|Target dose is midodrine hydrochloride or placebo pills 10 mg three times a day for 12 months. The starting dose is 5mg q4h x3, and if tolerated a forced titration up to 10mg/dose. If there is an intolerance, then the dose can be reduced to 2.5mg/dose.
16192052|NCT01456481|Drug|matching placebo|The target dose in this study is 10mg q4h x3 for 12 months. The starting dose is 5mg q4h x3, and if tolerated a forced titration up to 10mg/dose. If there is an intolerance, then the dose can be reduced to 2.5mg/dose.
16192053|NCT01456468|Drug|Oral all-trans retinoic acid (ATRA)|"The subjects will continue to take their current dose of UDCA (15 mg/kg/day), as per ongoing clinical care, and need to be on a stable dose of UDCA for at least six months prior to enrollment.
~The specific intervention is the addition of daily oral ATRA (45 mg/m^2) divided into 2 doses. To increase adherence to the dosing regimen, the drug will be compounded by the Research Pharmacies of Yale and Mayo into 2 formulations (30 mg and 40 mg capsules), and an Investigational New Drug (IND) permit was obtained for this process."
16192054|NCT01456442|Device|anorectal manometry|High-resolution anorectal manometry is done under standard clinical conditions with a 10 cm catheter inserted into the rectum loaded with pressure transducers at a distance of 6 mm in the sphincter area and an attached latex balloon at the catheter tip. It will measure the length of the anal sphincter, the static pressure and the clamping pressure during at least 3 over 40 seconds sustained maneuvers according to a standardized protocol. Mean and maximum pressure increase over the resting pressure during the first 30 seconds of the squeeze and the maximum possible squeeze time will be documented. Moreover, the initial anorectal perception threshold, the perception of urge to defecate and maximum tolerable volume balloon will be documented.
16192055|NCT01456442|Device|barostat|For the barostat study a balloon will be attached to the catheter. Instead of a barostat machine a 60ml syringe and a sphygmomanometer will be connected to the catheter and the catheter will be positioned in the rectum. The balloon is then dilated gradually to assess perception, urge and discomfort threshold in relation to rectal volume.
16192056|NCT01456429|Procedure|Thoracic endosonography|Endobronchial-ultrasound controlled transbronchial needle aspiration (EBUS-TBNA) in combination with a transoesophageal-ultrasound controlled needle aspiration of mediastinal lymph nodes
16192057|NCT01456403|Other|Histological validation|3D ultrasound, PET/CT, MRI, contrast ultrasound
16192058|NCT01456390|Device|iStent and iStent supra|Implantation of two iStent devices and one iStent supra device
16192059|NCT01456377|Drug|predinose oral|1 mg for kg for 3 wekees
16192060|NCT01456377|Drug|placebo group|use a oral placebo
16192061|NCT01456364|Drug|Ticagrelor|A loading dose of 180 mg of ticagrelor is administered followed by 90 mg maintenance doses twice daily
16192062|NCT01456364|Drug|Prasugrel|A prasugrel loading dose of 60 mg is administered followed by a 10 mg per day maintenance dose for patients < 75 years or a 5 mg maintenance dose per day for patients >= 75 years
16192063|NCT01456351|Drug|Bendamustine plus Rituximab|Bendamustine 90 mg/m² d 1+2 + Rituximab 375 mg/m² d 1 q4w for maximum 6 cycles
16192064|NCT01456351|Drug|Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w|Fludarabine 25 mg/m² d 1-3 + Rituximab 375 mg/m² d 1 q4w for maximum 6 cycles
16192065|NCT01456338|Behavioral|Cognitive Behavioral Therapy for PTSD|Individual CBT, approx. 12 sessions, one session per week
16192066|NCT01456338|Behavioral|Individual Addiction Counseling|Individual therapy, approx. 12 sessions, one session per week
16192067|NCT01456325|Drug|Erlotinib|Participants will receive erlotinib 150 mg tablet orally once daily from Day 1, Cycle 1.
16192068|NCT01456325|Drug|Onartuzumab (MetMab)|Participants will receive onartuzumab 15 mg/kg IV infusion on Day 1 of every 3-week cycle.
16192069|NCT01456325|Drug|Placebo|Participants will receive onartuzumab matching placebo on Day 1 of every 3-week cycle.
16192070|NCT01456312|Drug|Peginterferon alfa-2a|Duration and combination
16192071|NCT01456312|Drug|Entecavir|combination
16192072|NCT01456299|Drug|Remifentanil 1|"Remifentanil 1: The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml."
16192073|NCT01456299|Drug|Control|The control group, which received an infusion of normal saline
16192074|NCT01456299|Drug|Remifentanil 2|"Remifentanil 2: The R2group, which received a target effect-site remifentanil concentration of 2 ng/ml."
16192075|NCT01456286|Drug|sapropterin|two weeks of treatment: 5 mg/kg per day during first week 10 mg/kg per day during second week
16192076|NCT01456273|Procedure|Traditional Medical Consultation|Group A will be divided into 2 subgroups : A1- Traditional medical consultation + placebo, and A2- traditional medical consultation plus omeprazole
16192077|NCT01456273|Procedure|Therapeutic Encounter|"Group B (who receive care Therapeutic Encounter) will be divided in subgroup B1, which will receive the Drug Therapy Classic and 2 in group B who received placebo."
16192078|NCT01456260|Drug|TAK-438|TAK-438 10 mg tablets, orally, once daily for 28-80 weeks.
16192079|NCT01456260|Drug|Placebo|Lansoprazole placebo matching capsules, orally, once daily for 28-80 weeks.
16192080|NCT01456260|Drug|TAK-438|TAK-438 20 mg tablets, orally, once daily for 28-80 weeks.
16192081|NCT01456260|Drug|Placebo|Lansoprazole placebo-matching capsules, orally, once daily for 28-80 weeks.
16192082|NCT01456260|Drug|Lansoprazole|Lansoprazole 15 mg capsules, orally, once daily for 28-80 weeks.
16192083|NCT01456260|Drug|Placebo|TAK-438 placebo-matching tablets, orally, once daily for 28-80 weeks.
16192084|NCT01456247|Drug|TAK-438|TAK-438 10 mg tablets, orally, once daily for 28-80 weeks.
16192085|NCT01456247|Drug|Placebo|Lansoprazole placebo-matching capsules, orally, once daily for 28-80 weeks.
16192086|NCT01456247|Drug|TAK-438|TAK-438 20 mg tablets, orally, once daily for 28-80 weeks.
16192087|NCT01456247|Drug|Placebo|Lansoprazole placebo-matching capsules, orally, once daily for 28-80 weeks.
16192088|NCT01456247|Drug|Lansoprazole|Lansoprazole 15 mg capsules, orally, once daily for 28-80 weeks.
16192089|NCT01456247|Drug|Placebo|TAK-438 placebo-matching tablets, orally, once daily for 28-80 weeks.
16192090|NCT01456234|Drug|Oseltamivir|Oseltamivir 75 mg BID
16192091|NCT01456221|Dietary Supplement|Omega3 and an hypocaloric diet.|Thirty caps with the supplement will be provided every mo during three mo. Supplement will be administered as gel caps containing 1.1 g of DHA and EPA (®MaxEpa, Merck Laboratory) Hypocaloric diet will start at admission and will continue during the six months of follow-up. It will consist in providing a personalized diet including: a) reduction of 700 Kcal from the usual diet considering lipids and carbohydrates, b) increasing fruits and vegetables intake up to six portions daily each, and c) incrementing the intake of fiber to 30 g a day through the inclusion of whole grains.
16192092|NCT01456221|Dietary Supplement|Sunflower oil with an hypocaloric diet.|Thirty caps with the placebo will be provided every mo during three mo. Placebo will be administered as gel caps containing 1g of sunflower oil, which is omega-3 free, and is not expected to produce anti-inflammatory or insulin sensitivity effects. Hypocaloric diet will start at admission and will continue during the six months of follow-up. It will consist in providing a personalized diet including: a) reduction of 700 Kcal from the usual diet considering lipids and carbohydrates, b) increasing fruits and vegetables intake up to six portions daily each, and c) incrementing the intake of fiber to 30 g a day through the inclusion of whole grains.
16192093|NCT01456208|Drug|Para-aminohippuric Acid|"Aminohippurate sodium is an agent to measure effective renal plasma flow (ERPF). It is the sodium salt of para-aminohippuric acid, commonly abbreviated PAH."
16192094|NCT01456208|Drug|Angiotensin II|Angiotensin II (Ang II) is a naturally occurring hormone whose primary purpose is to regulate the body's internal volume. It accomplishes this task by influencing the function of a variety of organs and tissues. It increases aldosterone secretion from the adrenal gland. It causes blood vessels to contract, particularly renal blood vessels, and it modifies the way the heart works.
16192095|NCT01456208|Drug|Norepinephrine|A hormone that is normally present in your body, which regulates your blood pressure.
16192096|NCT01456195|Drug|Placebo|Fasiglifam placebo-matching tablets
16192097|NCT01456195|Drug|Fasiglifam|Fasiglifam tablets
16192098|NCT01456182|Drug|AFX-2|Dose level 1
16192099|NCT01456182|Drug|AFX-2|Dose level 2
16192100|NCT01456182|Drug|AFX-2|Dose level 3
16192101|NCT01456182|Drug|AFX-2|Dose level 4
16192102|NCT01456182|Drug|AFX-2|Dose level 5
16192103|NCT01456169|Drug|Azilsartan medoxomil/placebo|Azilsartan medoxomil and placebo to chlorthalidone combination tablets
16192104|NCT01456169|Drug|Azilsartan medoxomil - chlorthalidone|Azilsartan medoxomil and chlorthalidone fixed dose combination tablets
16192105|NCT01456156|Radiation|postoperative radiotherapy|IMRT or 3DCRT, 50-60Gy to the tumor bed
16192106|NCT01456143|Device|High Resolution Microendoscopy (HRME)|High Resolution Microendoscopy imaging device that operates as a fluorescence microscope with a fiber optic imaging probe. The probe is placed against the mucosa to obtain images relayed to a tablet computer.
16192107|NCT01456143|Other|Proflavine hemisulfate|0.01% Proflavine hemisulfate used as a fluorescent contrast agent applied topically to mucosa
16192108|NCT01456130|Drug|Alogliptin|Alogliptin tablets
16192109|NCT01456130|Drug|Rapid-acting insulin secretagogue|Either of the following commercially available rapid-acting insulin secretagogues as prescribed by the Investigator: (i) Nateglinide: Dose: 30 mg tablet or 90 mg tablet (ii) Mitiglinide calcium hydrate: Dose: 5 mg tablet or 10 mg tablet
16192110|NCT01456117|Drug|Pioglitazone|Pioglitazone once daily for up to 14 days.
16192111|NCT01456117|Drug|Pioglitazone|Pioglitazone once daily for up to 14 days.
16192112|NCT01456117|Drug|Pioglitazone|Pioglitazone once daily for up to 14 days.
16192113|NCT01456117|Drug|Placebo|Pioglitazone matching placebo once daily for up to 14 days.
16192114|NCT01456104|Biological|Langerhans-type dendritic cells (a.k.a. Langerhans cells or LCs)|Patients will receive a total of 5 vaccinations, comprising a primary immunization followed by four boosters at 3 week intervals with a window of ± 4 days. Vaccines will be dosed at 10x106 LCs per vaccine x 5.
16192115|NCT01456091|Behavioral|AIM 4 Teen Moms|The AIM (Adult Identity Mentoring) 4 Teen Moms program is a combination of individual and small group sessions intervention that encourages parenting young women ages 15-19 years old to delay rapid repeat pregnancies for 24 months or later.
16192116|NCT01456078|Drug|177Lu-DOTA-TATE|"177Lu-DOTA-TATE given as intravenous infusion given during 3-5 treatments. Evaluation is performed after every single cycle. Further more, evaluation is made after last cycle, and delivered cumulative dose to kidneys should be 27 Gy.
~Patients with stable disease or partial response, and without pronounced toxicity will continue treatment to a step 2, where additional 3-5 treatment cycles are given, with a cumulative dose to kidneys to 40 Gy."
16192189|NCT01455441|Other|Training and liraglutide|
16192190|NCT01455441|Other|Training and placebo|
16195719|NCT01428622|Drug|BI54903|ethanolic solution
16192117|NCT01456065|Biological|Procure|The IMP (Investigational Medical Product) consists of 1.3*107 autologous, fully mature DCs, double loaded with TERT-mRNA and Survivin-peptide, diluted in 0.5 mL of a standard freezing solution, made up of 10% DMSO (Dimethyl sulfoxide), solved in a physiologic water solution of 5% glucose; provided in a 2 mL cryovial. 8 vial will be injected on weekly administration basis to the patient.
16192118|NCT01456065|Biological|Procure|The IMP consists of 1.3*107 autologous, fully mature DCs, double loaded with TERT-mRNA and Survivin-peptide, diluted in 0.5 mL of a standard freezing solution, made up of 10% DMSO, solved in a physiologic water solution of 5% glucose; provided in a 2 mL cryovial, 8 vials will be injected into the patient on biweekly basis.
16192119|NCT01456052|Drug|Telotristat Etiprate|500 mg telotristat etiprate (LX1606) administered orally.
16192120|NCT01456052|Drug|Placebo|Matching placebo administered orally.
16192121|NCT01456039|Drug|Romidepsin|Intravenous dosing for 4 hours on Days 1, 8, and 15 of each 28-day cycle
16192122|NCT01456026|Dietary Supplement|Glycated beta-lactoglobulins.|oral, 20 g, single administration
16192123|NCT01456026|Dietary Supplement|Non-glycated beta-lactoglobulins|20 g, oral, single administration,
16192124|NCT01456013|Device|RenalGuard Therapy|Induced Diuresis with matched replacement
16192125|NCT01456013|Drug|Standard Therapy|Standard of care for patients at risk of CIN
16192126|NCT01456000|Device|EAS-AC (HeartLight)|Pulmonary vien isolation
16192127|NCT01456000|Procedure|Control Arm Ablation|Treatment with standard ablation.
16192128|NCT01455974|Other|Decreasing dialysate sodium from 138 mmol/L to 136 mmol/L|After 1-month period of dialysis with standard dialysate sodium concentration 138mmol/L, patients were followed up over a 1-year period with dialysate sodium set at 136mmol/L, without changes in instructions to patients about dietary sodium.
16192129|NCT01455948|Device|Relieva Balloon Sinuplasty™ System|Catheter-based devices used to dilate blocked paranasal sinus ostia (openings).
16192130|NCT01455948|Procedure|Functional Endoscopic Sinus Surgery|Specialized probes are used to cannulate closed ostia (openings), and small forceps are used to resect periostial bone and tissue to enlarge the sinus ostia.
16192131|NCT01455935|Drug|Anti-platelets and statin|
16192132|NCT01455935|Drug|alteplase|"Full dose Intravenous thrombolysis
~0.9 mg/kg
~Maximum dose is 90 mg
~10% of the dose will be given over one minute
~90% of the dose will be infused over 1 hour
~Admission to Neuro Intensive Care Unit(NICU) for 24 hours if no complications
~Neuro checks every 5 minutes during the infusion
~Neuro checks every hour after the infusion for 24 hours"
16192133|NCT01455935|Procedure|intra arterial intervention|"Intra arterial Activase (Maximum dose of 22 mg)
~MERCI device (Maximum of 3 tries per device, no standard time frame for how long the procedure takes)
~PENUMBRA device (no standard time frame for how long the procedure takes)"
16192134|NCT01455922|Drug|ITCA 650|ITCA 650 is exenatide in DUROS
16192135|NCT01455922|Drug|glimepiride|glimepiride will be up-titrated to 8 mg/day over first 13 weeks
16192136|NCT01455909|Drug|ITCA 650 60 mcg/day|exenatide in DUROS
16192137|NCT01455909|Drug|sitagliptin|sitagliptin oral 100 mg/day
16192138|NCT01455896|Drug|ITCA 650|ITCA 650
16192139|NCT01455896|Other|ITCA placebo|ITCA placebo
16192140|NCT01455883|Drug|ITCA 650 60 mcg/day|exenatide in DUROS
16192141|NCT01455883|Drug|glimepiride|oral glimepiride does-escalated,if tolerated, to 8 mg/day
16192142|NCT01455870|Drug|ITCA 650 60 mcg/day|exenatide in DUROS
16192143|NCT01455870|Drug|sitagliptin|oral sitagliptin 100 mg/day
16192144|NCT01455857|Drug|ITCA 650|ITCA 650 is exenatide in DUROS
16192145|NCT01455857|Other|ITCA placebo|Formulation in DUROS (no exenatide)
16192146|NCT01455844|Drug|CaPre (TM)|CaPre™ 1.0g + Placebo 1.0g daily for 12 weeks.
16192147|NCT01455844|Other|Placebo|2.0g Placebo (Microcrystalline cellulose) daily for 12 weeks
16192148|NCT01455844|Drug|CaPre (TM)|CaPre™ 2.0g daily for 12 weeks
16192149|NCT01455831|Drug|Tinzaparin|The experimental arm will receive a subcutaneous injection of 4,500 IU of tinzaparin daily beginning at randomization and continued for 56 days following resection. There will be a minimum of one dose of pre-operative LMWH since it is not reasonable to delay surgery for the purpose of administering LMWH. The maximum duration of pre-operative LMWH will be 6 weeks.
16192150|NCT01455831|Drug|Tinzaparin|The control arm will receive a daily subcutaneous injection of 4,500 IU of tinzaparin beginning with the first post-operative dose and continued for the duration of hospitalization.
16192151|NCT01455805|Device|Minuteman Fusion Implant|The Minuteman™ interspinous interlaminar fusion device consists of a central threaded portion that has a two-part wing plate hinged near its proximal end, with spikes on the extended distal end of the wing plate, and a multi-spiked end cap plate that is located at the distal end of the device and is retained and tightened in place with a locking hex nut. Compression between the spiked wing plate and the spiked end cap plate serves to fix the spinous processes in place and to facilitate fusion, together with bone graft fusion material placed within the device. The threaded external body has been designed to provide ease of distraction and insertion via a minimally invasive surgical procedure.
16192152|NCT01455805|Procedure|surgical decompression|Surgical decompression refers to the following operations Laminectomy, Foraminotomy, Discectomy or any other surgical procedure that the clinician feels is relevant for the decompression of lumbar spinal stenosis
16192153|NCT01455792|Procedure|Biopsies using image fusion|MRI and soft image fusion guided biopsy
16192154|NCT01455792|Procedure|Gold standard biopsy|Gold standard TRUS biopsy
16192155|NCT01455779|Device|Lyrette|"The Verathon Transurethral RF System (Lyrette® System) is indicated for the treatment of female urinary stress incontinence (SUI) due to hypermobility in women who have failed conservative treatment and who are not candidates for surgical therapy.
~The treatment is a 9 minute non-surgical procedure completed using local anesthesia during a single office visit. Women are discharged home with no incisions, dressings, or catheters immediately following treatment."
16192156|NCT01455753|Other|Functional Proximity|Using each employee's building entry/exit swipe card data, we test whether functional proximity-the likelihood that the employee walks by the clinic for reasons other than vaccination-predicts whether the employee gets vaccinated at the clinic.
16192157|NCT01455753|Other|Base Proximity|We also test whether base proximity-the inverse of walking distance from the employee's desk to the clinic-predicts vaccination probability.
16192158|NCT01455740|Behavioral|Provider Visit Incentive (PVI)|"All participants received the standard of care (SOC), which included not only medical care but also a wide range of social services. In addition, participants in the PVI arm received financial incentives designed to motivate health-improving behaviors. After the initial study enrollment visit, participants in the PVI arm received a $30 payment each time they showed up as scheduled for one of their next four HIV primary care visits.
~Participants in the PVI arm were also asked to return for a sixth, unanticipated study visit approximately three months after the last of the four study visits to which the incentive scheme applied. To reduce attrition, participants were offered $100 for showing up to the fifth and sixth study visits."
16192159|NCT01455740|Behavioral|Incentive Choice (IC)|"All participants received the SOC. In addition, participants in the IC arm received financial incentives designed to motivate health-improving behaviors. At the initial study enrollment visit, participants in the IC arm chose between either the incentive scheme assigned to the PVI arm or an incentive scheme that tied payments to clinic attendance and ART medication adherence. Participants who selected the 2nd option received a $30 payment at each of their next 4 HIV primary care visits if the (i) showed up as scheduled and (ii) presented a dose-recording pill bottle cap indicating that they correctly took at least 90% of doses of a sentinal medication since the previous study visit.
~Participants in the IC arm were also asked to return for a 6th, unanticipated study visit approximately three months after the last of the 4 study visits to which the incentive scheme applied. To reduce attrition, participants were offered $100 for showing up to the 5th and 6th study visits."
16192160|NCT01455727|Other|Pharmaceutical care|The Pharmacist provided Pharmaceutical care on the ambulatory elderly Diabetes patients, provided recommendation to the physician and reffered the patients to other diabetes-care-team members, including the CDEs and dietitians.
16192161|NCT01455727|Other|Usual care|Control patients received usual care directed by their physician.
16192162|NCT01455701|Drug|Tocilizumab|Tocilizumab will be administered as indicated in the arm description.
16192163|NCT01455688|Drug|early HAART|Initiation of HAART within 5 days of ICU admission
16192164|NCT01455688|Drug|Late HAART|Initiation of HAART after ICU discharge
16192165|NCT01455675|Drug|IgY|Avian polyclonal anti-pseudomonas antibodies (IgY)
16192166|NCT01455675|Drug|Placebo|Placebo, 70 ml gargling solution, once daily
16192167|NCT01455649|Drug|Everolimus|Group will switch calcineurin inhibitor to everolimus within 1 day (overnight).
16192168|NCT01455649|Drug|calcineurin inhibitor|Group will maintain their initial immunosuppression therapy with calcineurin inhibitor
16192169|NCT01455636|Other|Hand Sanitizer|The water-based hand sanitizer to be used in the current project will be produced in India by Hexagon Inc. It will be dispensed via a foam dispenser, since it has been established that foam is preferable to gel because of the natural tendency to rub foam more thoroughly into one's hands.
16192170|NCT01455636|Dietary Supplement|Improved Micronutrient Powder|A modified and improved formulation of MNPs will be used. The composition is specially designed to enhance appetite and growth with 17 essential micronutrients; including calcium and magnesium, as well as an increased amount of zinc (10 mg). Previously MNP formulations (including the UNICEF formulation) contained only 5 mg of zinc and did not contain magnesium and calcium, which are essential nutrients for bone formation.
16192171|NCT01455636|Other|No hand sanitizer|"All family members will receive hand-hygiene education with Information, Education and Communication (IEC) materials including pictorial messages describing critical points for hand-hygiene.
~No placebo for the hand sanitizers will be provided to families in Groups 3 and 4 because it would be unethical if families were to use an inactive hand-hygiene product as a substitute for routine hand-washing. Nevertheless, all groups will be instructed"
16192172|NCT01455636|Dietary Supplement|No Micronutrient Powder|I-MNP and placebo will be procured from a local pharmaceutical company in Dhaka, Bangladesh (Renata Pharma Ltd.). The outer-packaging of the sachets of 'I-MNP' and 'placebo-MNP' will be identical except for a different numeric code for each.
16192173|NCT01455597|Drug|Estradiol Vaginal Gel|Estradiol vaginal gel containing 0.017 mg estradiol per gram, 3X weekly for 40 weeks
16192174|NCT01455584|Drug|HM781-36B tablets|Q1X28D/4W for HM781-36B tablets
16192175|NCT01455571|Drug|HM781-36B|Q1DX14/2W for 3W HM781-36B
16192176|NCT01455558|Drug|Pletaal|"Part 1: a single dose of the SR (200mg x 1 tablet, QD) and IR (100mg x 2 tablets, BID) formulation of cilostazol orally 7 days apart in a fasted state
~Part 2: a single dose of the SR (200mg x 1 tablet, QD) formulation of cilostazol 7 days apart in a fasted and a fed state
~Part 3: multiple doses of the two formulations for eight consecutive days 21 days apart"
16192177|NCT01455532|Drug|Iniparib (SAR240550-BSI-201)|"Pharmaceutical form:Solution for infusion
~Route of administration: Intravenous"
16192178|NCT01455532|Drug|Gemcitabine|"Pharmaceutical form:Solution for infusion
~Route of administration: Intravenous"
16192179|NCT01455532|Drug|Carboplatin|"Pharmaceutical form:Solution for infusion
~Route of administration: Intravenous"
16192180|NCT01455532|Drug|Placlitaxel|"Pharmaceutical form:Solution for infusion
~Route of administration: Intravenous"
16192181|NCT01455532|Drug|Pegylated liposomal doxorubicin|"Pharmaceutical form:Solution for infusion
~Route of administration: Intravenous"
16192182|NCT01455519|Drug|Hydromorphone ER|Total target dose of 32 mg/day. All subjects will have a lead in for 2 weeks; then begin a 'forced' 2-week up-titration schedule as follows: 8mg/d (1 pill, 5 days), 16mg mg/d (2 pills, 5 days), and 24mg/d (3 pills, 5 days) then finally 32 mg/d (4 pills a day) for the 'stable dose' phase of the study, or identical placebo pills. If intolerable side effects occur, the dose may be reduced to last tolerable does, a minimum of 8 mg/day (or one pill a day), at the discretion of the PI. Subjects unable to tolerate 8 mg/day will be discontinued from the study. A 2-week down-titration will be used.
16192183|NCT01455519|Drug|Sugar pill|Sugar pill
16192184|NCT01455506|Drug|Decitabine plus Fludarabine and Busulfan|"Decitabine will be administered at a dose of 60 mg/m2 IV daily based on adjusted body weight for patient >20% above ideal body weight
~Fludarabine will be administered at a dose of 30/mg/m2 IV daily for 5 days starting on transplant day -7.
~Busulfan will be administered at a dose of 130 mg/m2 IV daily for 2 days on transplant days -4 and -3.
~Patients will also receive rabbit antithymocyte globulin (Thymoglobulin) at a dose of 2 mg/kg IV daily for 3 days on transplant days -4, -3, and -2.
~Hematopoietic cells will be infused on day 0."
16192185|NCT01455493|Drug|GDC-0980|Oral daily dose
16192186|NCT01455480|Drug|RPh201, botanical drug product|topical
16192191|NCT01455428|Drug|Lyrica (pregabalin)|Capsule, 300 mg/d, BID, 8 weeks treatment
16192192|NCT01455428|Drug|Placebo|Capsule, 300 mg/d, BID, 8 weeks treatment
16192193|NCT01455415|Drug|pregabalin|150 - 300 mg/day in divided dose (3 time a day) for 6 weeks
16192194|NCT01455415|Drug|placebo|matching placebo 3 time a day
16192195|NCT01455389|Drug|DOTAP:Chol-TUSC2|Starting Dose 0.045 mg/kg by vein on day 1 of each 21 day cycle; Phase II is Maximum Tolerated Dose from Phase I.
16192196|NCT01455389|Drug|Erlotinib|Starting Dose 100 mg by mouth each day of a 21 day cycle (except for first week of Cycle 1, if enrolled in Phase II delayed-schedule group). Phase II is Maximum Tolerated Dose from Phase I.
16192197|NCT01455389|Drug|Dexamethasone|8 mg orally 24 and 12 hours and 20 mg by vein 30 minutes before DOTAP:Chol-TUSC2 treatment followed by 8 mg orally at 12, 24 and 36 hours after treatment (total number doses = 5).
16192198|NCT01455389|Drug|Diphenhydramine|50 mg by mouth or by vein 30 minutes prior to treatment with DOTAP:Chol TUSC2
16192199|NCT01455376|Drug|hyperosmolar sodium lactate|Patients in this group received intravenous infusion of hyperosmolar sodium lactate at 1.5 ml.KgBW-1 within 15 minutes before neurosurgery
16192200|NCT01455363|Procedure|BCC surgery|This clinical trial will use skin flap model for trunk and facial BCC, with respect the classical excision margin of BCC surgery (3-4mm): after local anesthesia, a little random pattern skin flap will be raised around the BCC, then the cutaneous pedicle will be clamped with surgical clamp for 3 minutes and clamp released.
16192201|NCT01455363|Other|Tourniquet ischemia|In case of limb BCC, limb tourniquet will be used, and occluded during 3 minutes upstream to the BCC location.
16192202|NCT01455363|Other|Laser speckle imaging|During all steps of experimentation, laser speckle imaging will be used to measure continuously the peri-tumoral and tumoral perfusion, start from tumor excision, up to10 minutes after tumor pedicle clamp or tourniquet release.
16192203|NCT01455350|Procedure|Multimodal physiotherapy|10 weeks of weekly physiotherapy treatments including relaxation techniques, stretching and pelvic floor muscle control exercises.
16192204|NCT01455350|Drug|lidocaine|10 weeks of daily topical 5% lidocaine application
16192205|NCT01455337|Drug|pentoxifylline|400mg tid
16192206|NCT01455337|Drug|Prednisolone|40mg qd
16192207|NCT01455324|Device|Novel conformable woven inner socket|Prosthetic socket liner fabricated from novel materials to allow passive conformability for the user
16192208|NCT01455311|Procedure|EUS Guided Fine Needle Aspiration|EUS-guided fine needle aspiration of the cyst fluid
16192209|NCT01455311|Procedure|EUS Guided EchoBrush Sampling|EUS-guided brushing of the cyst wall
16192210|NCT01455298|Other|Transient Elastography and fibrotest|a Transient Elastography and an ultrasound are performed.
16192211|NCT01455285|Device|transcutaneous electrical nerve stimulation|
16192212|NCT01455272|Procedure|prophylactic GPBPCI|A G-CSF-primed PBPCI was planned within day 60 post-transplantation before hematologic relapse was diagnosed
16192213|NCT01455259|Biological|AdCD40L|Adenoviral serotype 5 vector, E1/E3 deleted. Human CD40L gene insert driven by RSV promoter. Vector diluted in infusion solution, 500uL solution containing 2.5x10e11 VP is intratumorally injected/treatment.
16192214|NCT01455246|Drug|Daptomycin + Meropenem|Daptomycin will be administered at the dose of 6 mg/kg every 24 hours and 6 mg/kg every 48 hours for an estimated creatinine clearance (CKD-EPI) of > 30 ml/min and < 30 ml/min respectively. Meropenem will be administered at the dose of 1 g t.i.d., 1 g b.i.d., 0.5 g every 24 hours for an estimated creatinine clearance of >50 ml/min, 10-50 ml/min, and < 10 ml/min respectively. The treatment will go on for 7 days. In the patients without response to treatment after 48 hours will be added a rescue therapy with fluconazole. In patients in which cultures shown a bacterial species resistant to therapy, daptomycin and meropenem will be discontinued and replaced by a therapy based on antibiotic susceptibility of isolated species.
16192215|NCT01455246|Drug|Ceftazidime|Ceftazidime will be administered at the dose of 2 g t.i.d, 2 g b.i.d and 2 g at every 24 hours by intravenous infusion for an estimated creatinine clearance (CKD-EPI) of >50 ml/min, 10-50 ml/min, and < 10 ml/min respectively. The treatment will go on for 7 days. In the patients without response to treatment after 48 hours, or in which cultures shown a bacterial species resistant to therapy, ceftazidime will be discontinued and replaced by a rescue therapy with meropenem and daptomycin as provided for the experimental arm
16192216|NCT01455233|Drug|besivance|topical ocular antibiotic, 1 drop in study eye QID starting 3 days prior and for 7 days following cataract surgery
16192217|NCT01455233|Drug|vigamox|topical ocular antibiotic, 1 drop in study eye QID for 3 days prior and for 7 days following cataract surgery
16192218|NCT01455220|Drug|Tysabri ® (Natalizumab)|IV, monthly
16192219|NCT01455207|Behavioral|Neuropsychological testing|assessment of memory, executive functions and ataxia
16192220|NCT01455207|Biological|blood draw|hepatic markers, red blood markers and vitamin markers
16192221|NCT01455207|Genetic|genetic testing|genes coding for thiamine enzymes (α-ketoglutarate dehydrogenase complex, transketolase et pyruvate dehydrogenase)
16192222|NCT01455207|Other|Brain imaging examination|MRI, DTI and PET examinations
16192223|NCT01455194|Drug|Ciclesonide|During the treatment period subjects will inhale two puffs of either 40, 80 or 160 μg ciclesonide in the morning and the evening (corresponding to a total daily dose of 160, 320 or 640 μg)
16192224|NCT01455181|Drug|NPSP558|50, 75, 100 μg
16192225|NCT01455155|Other|Creative therapy (art and music therapy)|Creative therapy composed of groups of activities relating to music and art sciences 8 sessions (2 sessions per week for 4 weeks) These activities emphasized on stimulating of cognition, physical, emotion, communication, social relationship, and spiritual domains.
16192226|NCT01455155|Other|Physical therapy|Physical therapy composed of a series of physical therapy program including types of exercises and gait training if possible (5 times/week).
16192227|NCT01455142|Drug|insulin degludec/insulin aspart|Single injection of each formulation. The dose level will be 0.5 U/kg body weight (BW). The trial products will be administered subcutaneously (under the skin).
16192228|NCT01455129|Drug|Tiotropium|18 mcg tiotropium capsule, once daily, inhaled by HandiHaler, for 24 months
16192229|NCT01455129|Drug|placebo|placebo, once daily, inhaled by HandiHaler
16192230|NCT01455116|Procedure|Mild Induced Hypothermia|Induction of hypothermia to a target temperature of 32 - 34 degrees Celsius (90 - 93 degrees Fahrenheit
16195720|NCT01428622|Drug|BI54903|ethanolic solution
16192231|NCT01455103|Biological|BMS-936559 (Anti-PD-L1)|Solution, Intravenous infusion, 1 mg/kg, Every 2 weeks, Up to 2 years, depending on response
16192232|NCT01455103|Biological|BMS-936559 (Anti-PD-L1)|Solution, Intravenous infusion, 3 mg/kg, Every 2 weeks, Up to 2 years, depending on response
16192233|NCT01455103|Biological|BMS-936559 (Anti-PD-L1)|Solution, Intravenous infusion, 10 mg/kg, Every 2 weeks, Up to 2 years, depending on response
16192234|NCT01455090|Drug|BMS-650032|
16192235|NCT01455090|Drug|BMS-790052|
16192236|NCT01455090|Drug|BMS-791325|
16192237|NCT01455090|Drug|Ribavirin|
16192238|NCT01455064|Device|FreeStyle Navigator II Continuous Glucose Monitoring System|This is not an interventional study. Subjects must maintain their own diabetes treatment regimen throughout the study duration
16192239|NCT01455051|Drug|Ofatumumab|We plan to add five doses of ofatumumab to the standard conditioning regimen (fludarabine + melphalan). Ofatumumab will be administered on days -20 (300 mg), -13 (2000 mg), -6 (2000 mg), +1 (1000 mg) and +8 (1000 mg) of the transplantation (day 0 being the day of the hematopoietic cell infusion). If the patient requires donor lymphocyte infusions within 3 years after the procedure, these infusions will also include one administration of 300 mg of ofatumumab, followed by a 1000 mg dose, 7 days later).
16192240|NCT01455025|Drug|Plerixafor granulocyte-colony stimulating factor|"Induction phase Plerixafor IV from D1 to D3 and from D8 to D10, granulocyte-colony stimulating factor IV 5 μg/kg/day from D1 to D10, Intravenous daunorubicin 60 mg/m2/day from D1 to D3 Cytarabine 500 mg/m2/day continuous infusion over 24h from D1 to D3 followed by cytarabine 2-hour bolus of 1000 mg/m2/12h from D8 to D10.
~Consolidation phase Plerixafor at D1, D3 and D5, granulocyte-colony stimulating factor IV 5 μg/kg/day from D1 to D5, Cytarabine continuous infusion of 3-h bolus of 3000 mg/m2/12h D1, D3 and D5"
16192241|NCT01455012|Drug|Rotigotine|Rotigotine 1 mg/24 h, 2 mg/24 h, and 3 mg/24 h. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.
16192242|NCT01455012|Drug|Placebo|Matching Placebo. Subjects will be titrated to their optimal/maximal dose in weekly increments of 1 mg/24 h during a Titration Period. During Maintenance Period the subjects will continue on their optimal/maximal dose for 28 days. Following the Maintenance Period, subjects will be de-escalated over 7 days, depending on their optimal/maximal dose.
16192243|NCT01454999|Behavioral|CTI|Web-based computerized, tailored intervention (CTI) for smoking cessation, based on the transtheoretical model of change.
16192244|NCT01454986|Drug|ALXN1007|Single dose, IV
16192245|NCT01454986|Other|Placebo|Single dose, IV
16192246|NCT01454960|Behavioral|Clinical Decision Support: Accountable Justification|Accountable Justification is triggered by discordant prescriptions that populate the EHR note with provider's rationale for guideline exceptions (AJ).
16192247|NCT01454960|Behavioral|Audit and Feedback: Peer Comparison|Performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparison).
16192248|NCT01454960|Behavioral|CDS Order Sets: Suggested Alternatives|Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives).
16192249|NCT01454947|Behavioral|Clinical Decision Support (CDS): Accountable Justifications|Accountable Justifications triggered by discordant prescriptions that populate the electronic health record (EHR) note with provider's rationale for guideline exceptions (AJ).
16192250|NCT01454947|Behavioral|Audit and Feedback: Peer Comparison|Performance feedback that benchmarks providers' own performance to that of their peers (PC, for Peer Comparison).
16192251|NCT01454947|Behavioral|CDS Order Sets: Suggested Alternatives|Order Sets that are triggered by EHR workflow containing exclusively guideline concordant choices (SA, for Suggested Alternatives).
16192252|NCT01454934|Drug|Eribulin|Administration of eribulin mesylate at a dose of 1.4 mg/m2 i.v. over 2 to 5 minutes on Days 1 and Day 8 of every cycle, where the duration of each cycle is 21 days.
16192253|NCT01454934|Drug|TPC -Vinorelbine,Gemcitabine,Docetaxel, and Pemetrexed|"Vinorelbine 30 mg/m2 i.v. on Day 1, every 7 days
~Gemcitabine 1250 mg/m2 i.v. on Days 1 and 8, every 21 days
~Docetaxel 75 mg/m2 i.v. on Day 1 every 21 days
~Pemetrexed 500 mg/m2 i.v. on Day 1 every 21 days (nonsquamous histology only)."
16192254|NCT01454921|Behavioral|Evolution: Young Women Taking Charge and Growing Stronger|The intervention aims to address the following concerns: 1) reducing the risk of young women infected with HIV transmitting the virus to their sexual partners, and 2) preventing young women infected with HIV from re-infection with a new viral strain or co-infection with another sexually transmitted disease (STD).
16192255|NCT01454908|Device|Oxford Partial Knee|The Oxford partial knee contains tibial and medial components and a mobile meniscal bearing.
16192256|NCT01454895|Behavioral|Sampler of hearing protection devices|In a pilot study, hearing protection devices were mailed to farmers, resulting in a significant increase in use. These results suggested that overall, HPDs were acceptable to farmers, and that access to HPDs may be an important contributor to frequency of use. The study will build on this earlier work by providing an assortment of hearing protection devices to a sub-sample of each group of farmers receiving the Interactive and Static Web Interventions. The assortment includes the most commonly used types of devices (i.e., muffs, foam plugs, pre-molded plugs, and semi-aurals). The sampler is delivered, together with manufacturers' standard written instructions for use, via mail at the designated time according study design.
16192257|NCT01454895|Behavioral|Static Web-based information|The standard information promoting HPD use delivered via Internet will be based on an informational brochure previously developed for use by farmers (i.e., Have You Heard? and They're Your Ears Protect Them). These brochures, including color graphics and text, are available on the Internet (as PDF files). Although they have been printed and distributed by NIOSH, most farmers will not have been exposed to copies. There are important differences between the SWI and IWI interventions, including interactivity, animation, explication of farmer-generated tips and techniques for addressing common barriers to hearing protector use, use of color, audio, and video, hotlinks, and farmer testimonials.
16192332|NCT01454245|Drug|JNJ-39439335|"Part 1:Type=1, unit=mg, number=25, form=capsule, route=oral use. One capsule (25 mg/day) taken once on Day 1 in 3 treatment periods.
~or Part 1:Type=2, unit=mg, number=12.5, form=capsule, route=oral use. Two capsules (25 mg/day) taken once on Day 1 in 3 treatment periods."
16192333|NCT01454232|Other|stools sampling|stools sampling at baseline, 1, 3 and 12 months
16192258|NCT01454895|Behavioral|Interactive Web-based information|This intervention includes a number of features/techniques designed to promote behavior change. Messages focus on farmer-friendly techniques for adopting use of HPDs. The factors found to be significant predictors of HPD use (Barriers to Use and Situational Factors Influencing HPD Use) are particularly relevant to farmers' learning needs, and are especially emphasized in this model-based intervention to increase hearing protector use among farmers. Participants will select the sequence of features they visit, as well as the time spent in each feature and number of visits to the site. Their patterns of use will be tracked by the enrollment and data collection systems and used in analysis.
16192259|NCT01454882|Behavioral|Effects of Clothing|There will be two temperature conditions; warm temperature [WT, 75°F (24°C)] and cool temperature [CT, 60°F (16°C)]. During each condition, subjects will vary the amount of clothing they are wearing at specified times
16192260|NCT01454882|Behavioral|Effects of Temperature|There will be two temperature conditions; warm temperature [WT, 75°F (24°C)] and cool temperature [CT, 60°F (16°C)]. During each condition, subjects will vary the amount of clothing they are wearing at specified times
16192261|NCT01454882|Behavioral|Low Physical Activity|This will be a randomized study with two within subject conditions (high and low physical activity levels)
16192262|NCT01454882|Behavioral|High Physical Activity|This will be a randomized study with two within subject conditions (high and low physical activity levels)
16192263|NCT01454882|Behavioral|Direct calorimetry and doubly labeled water|TDEE will be measured simultaneously for 14 days using direct calorimetry and doubly labeled water. A heterogeneous sample of adult men and women in stable health will be studied.
16192264|NCT01454869|Drug|standard care|Standard care treatment consist of chest physiotherapy ,early ambulation, airway suctioning, bronchial hygiene therapy , salbutamol nebulization(100-200 µgQ4h)/N-acetyl cysteine20% nebulization(3cc Q4h) and if needed mechanical ventilation support.
16192265|NCT01454869|Drug|Heparin|Study group would consist of 85 burn patients with documented smoke inhalation injury who will be randomized to receive standard care plus heparin nebulization(5000U every 4 hours for 7 days) in combination with intravenously administrated fresh frozen plasma(10 cc/Kg daily for 7 days).
16192266|NCT01454843|Procedure|Wavefront-guided LASIK - Allegretto|Wavefront-guided LASIK using the Allegretto excimer laser for myopia.
16192267|NCT01454843|Procedure|Wavefront-guided LASIK - AMO|Wavefront-guided LASIK using the AMO CustomVue excimer laser for myopia.
16192268|NCT01454830|Behavioral|Tailored|Individualized on critical indicator (Self-efficacy measure in Sleep Apnea) measured at each intervention delivery period (pre-diagnosis, immediately post-diagnosis, post-CPAP titration, and during week 1 of home CPAP treatment. Intervention components include patient education, preparatory skills training, modification of inaccurate/unrealistic cognitive perceptions of risk, outcome expectations, and treatment self-efficacy
16192269|NCT01454830|Other|Usual care|Usual care comparison group will proceed from initial clinical evaluation for OSA, diagnosis by polysomnography, CPAP titration polysomnography, and home CPAP treatment initiation as per current standard of care
16192270|NCT01454817|Behavioral|Quality of life|Improving Quality of Life
16192271|NCT01454804|Drug|Pazopanib|Starting dose: 200 mg by mouth every other day starting on day 1 for 28 days.
16192272|NCT01454804|Drug|Lapatinib|Starting dose 500 mg by mouth every day for 28 days.
16192273|NCT01454804|Drug|Trastuzumab (Herceptin®)|"4 mg/kg loading dose as a 90 minute infusion by vein on day 1 of cycle 1.
~Maintenance dose of 2 mg/kg every week as 30 minute infusion by vein.
~Dose Expansion Phase: Maximum tolerated dose (MTD) from Dose Escalation Phase"
16192274|NCT01454804|Drug|Pazopanib|Starting dose 200 mg by mouth every day for 28 days.
16192275|NCT01454791|Drug|diclofenac sodium topical gel|diclofenac sodium topical gel 1% applied 1-4 times per day for two weeks either preceded by or followed by two weeks of placebo
16192276|NCT01454791|Other|Placebo|a placebo gel is applied 1-4 times per day for two weeks.
16192277|NCT01454778|Drug|Paclitaxel|"Paclitaxel in addition to angioplasty, stenting or atherectomy Dosing will be based on the lesion surface area, and will be calculated using the following formula: dose= 22/7 X diameter (mm) X length (mm) X 3 micrograms/mm^3
~Paclitaxel Dosage:
~Superficial Femoral/Common Femoral: 2.4 mg/inflation of balloon* Popliteal: 1.8 mg/inflation of balloon* Tibial: 1.4 mg/inflation of balloon*
~not to exceed 10mg total dose"
16192278|NCT01454765|Other|generation of stem cells|Collected germ cells will be cultured in medium. The germ cell cultures will be infected with reprograming factors. Rare colonies with characteristic stem cell morphologies will be expanded.
16192279|NCT01454752|Drug|Intermittent parasite clearance|Sulphadoxine-pyrimethamine (500/25mg) according to age, given on day 1; Amodiaquine (200mg) according to age, given daily for 3 days
16192280|NCT01454752|Other|Placebo|Placebo tablets, similar in appearance and taste to active treatment, given daily over 3 days
16192281|NCT01454739|Drug|rFVIIIFc|Administered as specified in the treatment arm.
16192282|NCT01454726|Other|Diaoshi Jifa therapy plus the Western medical treatment.|Diaoshi Jifa treatment
16192283|NCT01454726|Other|drug|the Western medical treatment alone.
16192284|NCT01454700|Device|Insulin pump therapy (CSII) plus continuous glucose monitoring (CGM)|Randomization to 12 months with CSII plus CGM
16192285|NCT01454700|Other|Multiple daily insulin injections (MDI)|Randomization12 months therapy with MDI
16192286|NCT01454687|Procedure|Grafting of Autologous Cultured Revertant Keratinocytes|Grafting of two to four epidermal sheets 40cm2 - 50cm2 onto wounded areas
16192287|NCT01454674|Other|2, 5 & 10 Vegetable doses|2,5 & 10 serving dose/day combination of fresh lettuce mix, baby carrots, red bell peppers & tomatoes consumed for 3 week intervals
16192288|NCT01454661|Dietary Supplement|LGG|Lactobacillus rhamnosus GG 10E9 cfu / day
16192289|NCT01454661|Dietary Supplement|LGG+Bb-12|A combination of the probiotics Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb-12 administered 10E9 cfu / day each.
16192290|NCT01454661|Dietary Supplement|Placebo|Microcrystalline cellulose is used as placebo.
16192291|NCT01454635|Drug|Sertraline|dosage,frequency and duration
16192334|NCT01454232|Other|adipose tissue biopsy|surgical adipose tissue biopsy during surgery, 1, 3 and 12 months
16192335|NCT01454219|Other|Bakery and confectionary products|Control product: Glucose solution, Test products: 11 bakery and confectionary products
16192666|NCT01451931|Other|Radiology CT|Computed tomography of abdomen completed in the radiology department at time 0.
16192292|NCT01454622|Drug|A (canagliflozin and metformin IR individual tablets) / B (canagliflozin/metformin IR FDC tablets)|Treatment A: Canagliflozin: Type = 1, unit = mg, number = 100, form = tablet, route = oral use + metformin IR: Type = 2, unit = mg, number = 1000, form = tablet, route = oral use. One canagliflozin tablet and 2 metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 1 followed 10-15 days later by Treatment B (canagliflozin/metformin IR FDC): Type = 2, unit = mg, number = 50/1000, form = tablet, route = oral use. Two canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 2
16192293|NCT01454622|Drug|B (canagliflozin/metformin IR FDC tablets / A (canagliflozin and metformin IR individual tablets)|Treatment B (canagliflozin/metformin IR FDC): Type = 2, unit = mg, number = 50/1000, form = tablet, route = oral use. Two Canagliflozin/metformin IR FDC tablets taken orally on Day 1 of Treatment Period 1 followed 10-15 days later by Treatment A: Canagliflozin: Type = 1, unit = mg, number = 100, form = tablet, route = oral use + Metformin IR: Type = 2, unit = mg, number = 1000, form = tablet, route = oral use. One canagliflozin tablet and 2 metformin IR tablets taken orally (by mouth) on Day 1 of Treatment Period 2.
16192294|NCT01454609|Drug|0.9% Normal saline|Saline
16192295|NCT01454609|Drug|Bupivacaine|Bupivacaine - amide local anesthetic, maximum recommended dose is 2 mg/kg duration 2 - 4 hours of sensory anesthesia up to 24 hours
16192296|NCT01454609|Device|Bupivacaine with clonidine (combination)|"Bupivacaine - amide local anesthetic, maximum recommended dose is 2 mg/kg duration 2 - 4 hours of sensory anesthesia up to 24 hours
~Clonidine - 0.5 - 1 microgram/ kg"
16192297|NCT01454596|Biological|Epidermal growth factor receptor(EGFRv)III Chimeric antigen receptor (CAR) transduced PBL|Day 0: Cells will be infused intravenously over 20-30 minutes. Patients will receive two cell doses, 2 hours apart.
16192298|NCT01454596|Drug|Aldesleukin|Aldeskeukin 72,000 IU /kg intravenous (IV) or 720,000 IU /kg IV (based on total body weight) over 15 minutes every eight hours (+/- 1 hour) beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses).
16192299|NCT01454596|Drug|Fludarabine|Days -7 to -3: Fludarabine 25 mg /m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
16192300|NCT01454596|Drug|Cyclophosphamide|Days -7 and -6: Cyclophosphamide 60 mg/kg/day X 2 days IV in 250 ml dextrose 5% in water (D5W) with Mesna 15 mg/kg /day X 2 days over 1 hr.
16192301|NCT01454583|Drug|Aliskiren|Aliskiren (Rasilez®, Novartis) is the first clinically available substance with direct renin inhibition (DRI) which effectively lowers blood pressure.
16192302|NCT01454583|Drug|ACE-I/ARB|
16192303|NCT01454583|Drug|No RAS-inhibition|
16192304|NCT01454570|Device|powered exoskeleton|
16192305|NCT01454557|Other|Auditory Stimuli|Auditory Stimuli during rest and during physical activity
16192306|NCT01454544|Biological|AIT Tablet|1 tablet per day in 12 months
16192307|NCT01454531|Drug|AVANZ Phleum pratense|AVANZ Phleum pratense up-dosing phase (300, 600, 3000, 6000 and 15,000 SQ+) + one 15,000 SQ+ maintenance injection
16192308|NCT01454518|Procedure|Infiltration of local anesthetic|30 ml of ropivacaine 0.5% infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance.
16192309|NCT01454518|Procedure|Normal Saline Injection|injection of 30ml normal saline infiltrated around lateral anterior and medial aspect of hip joint with ultrasound guidance.
16192310|NCT01454505|Drug|AL-53817 nasal spray solution|Active ingredients administered in 1 of 3 concentrations during Stage A to determine maximum tolerated dose (MTD), and administered at maximum tolerated dose during Stage B.
16192311|NCT01454505|Other|Vehicle nasal spray|Inactive ingredients used as placebo comparator during Stage A and Stage B.
16192312|NCT01454479|Drug|Lapatinib and ixempra|Ixabepilone 40 mg/m2 Lapatinib 250 mg
16192313|NCT01454466|Procedure|Partial posterior hyaloidectomy (a modified procedure of vitrectomy)|The core vitrectomy entails more extensive removal of vitreous gel, in contrast to the conventional core vitrectomy. IPVD was conducted by engaging the attached posterior cortical vitreous with a 23-gauge needle with angulated tip in the area adjacent to the optic disc followed by gently moving the tip to approximately 3 disc diameters away from the margin of the optic disc. After then, slightly elevating the tip in a posteroanterior direction with slowly proceeding it to the extent that we planned. With IPVD, the surgeon was able to visualize a floating Weiss ring in all of the cases. Active suction to initiate IPVD was not used in any of the cases. In the temporal direction, the extension of a PVD was restricted to approximately 2 disc diameters distance beyond the margin of temporal major vascular arcade
16192314|NCT01454453|Drug|Patients- dose titration|dose titration (patients) - 4-10 weeks
16192315|NCT01454440|Drug|Eptifibatide|Intravenous eptifibatide (double bolus [180 microg/kg] followed by infusion [2 microg/kg per minute] for 18 to 24 hours after the procedure) vs placebo.
16192316|NCT01454414|Other|Permethrin Impregnated Uniforms|Uniforms treated with permethrin according to proprietary process used by Insect Shield, Inc.
16192317|NCT01454401|Device|LeucoPatch treatment|weekly
16192318|NCT01454388|Other|breakfast|
16192319|NCT01454375|Behavioral|Referral to QuitNow Services|QuitNow Services is a telephone counseling program supported by the Ministry of Health Living and Sport that counsels individuals to stop smoking
16192320|NCT01454362|Drug|Nicotine|Inhalation of nicotine.
16192321|NCT01454349|Drug|PRX302|Single intraprostatic injection with an ascending dose per cohort of 0.75, 1.5, 3.0, and 6.0 µg/mL
16192322|NCT01454349|Drug|Placebo|Single intraprostatic injection of matching placebo
16192323|NCT01454336|Biological|Cell injection|MSCs introduced into portal vein
16192324|NCT01454323|Other|Bone marrow mononuclear cells|Intracoronary infusion of autologous bone marrow-derived mononuclear cells
16192325|NCT01454310|Device|Wound coverage by acellular skin substitute|Burn wounds are covered by an acellular skin substitute and remains 10-14 days that peals away in line with re-epithelialisation
16192326|NCT01454310|Device|Autologous skin|Matched burn wound is covered by autologous skin after tangential excision.
16192327|NCT01454284|Drug|Glargine|
16192328|NCT01454284|Drug|LY2605541|
16192329|NCT01454284|Drug|Insulin Lispro|
16192330|NCT01454271|Procedure|Total Hip Arthroplasty Replacement|Total Hip Arthroplasty Replacement
16192331|NCT01454245|Drug|JNJ-39439335|Part 2:Type=2, unit=mg, number=12.5, form=capsule, route=oral use. Two capsules taken (25 mg/day) once on Day 1 in 2 treatment periods.
16192446|NCT01453530|Other|Placebo|Placebo
16195721|NCT01428622|Drug|BI54903|ethanolic solution
16192336|NCT01454206|Behavioral|iSBIRT|"Participants will be screened for substance use, view information about the health effects of substance use on the computer, and receive advice from the primary care provider regarding the health effects of substance use. Those found to be at high risk will complete an internet-based program encouraging them to change their substance use."
16192337|NCT01454180|Drug|gemcitabine, or gemcitabine and capecitabine, or gemcitabine and erlotinib, or FOLFIRINOX, or FOLFOX, or FOLFIRI.|"Gemcitabine 1000 mg/m2 weekly for 7 weeks, then weekly regimen of 3 weeks every 4 weeks.
~Gemcitabine - Capecitabine (GEM-CAP):Gemcitabine 1000 mg/m2 weekly for 3 weeks, Capecitabine 830 mg/m2 orally every 12 hours daily for 3 weeks; every 4 weeks.
~Gemcitabine-Erlotinib: Gemcitabine 1000 mg/m2 weekly for 7 weeks, then weekly regimen of 3 weeks every 4 weeks, Erlotinib 100 mg orally daily
~FOLFOXIRI: Oxaliplatin 85 mg/m2,irinotecan 180 mg/m2, folinic acid 400 mg/m2, 5'Fluouracilo 400 mg / m2, 5 'fluorouracil 2400 mg/m2 continuous intravenous infusion of 46 hours. Repeated every 14 days.
~FOLFOX: Oxaliplatin 85 mg/m2, folinic acid 400 mg/m2, 400 mg/m2 5'Fluouracilo, 2400 mg/m2 5'Fluouracilo continuous intravenous infusion of 46 hours. Repeated every 14 days.
~FOLFIRI: Irinotecan 180 mg/m2, folinic acid 400 mg/m2, 400 mg/m2 5'Fluouracilo intravenous bolus, 5'Fluouracilo 2400 mg / m2 continuous intravenous infusion for 46 hours. Repeated every 14 days."
16192338|NCT01454180|Drug|Gemcitabine, Gemcitabine-Capecitabine, Gemcitabine-Erlotinib, FOLFOXIRI, FOLFOX, FOLFIRI|"Gemcitabine 1000 mg/m2 weekly for 7 weeks, then weekly regimen of 3 weeks every 4 weeks.
~Gemcitabine - Capecitabine (GEM-CAP):Gemcitabine 1000 mg/m2 weekly for 3 weeks, Capecitabine 830 mg/m2 orally every 12 hours daily for 3 weeks; every 4 weeks.
~Gemcitabine-Erlotinib: Gemcitabine 1000 mg/m2 weekly for 7 weeks, then weekly regimen of 3 weeks every 4 weeks, Erlotinib 100 mg orally daily
~FOLFOXIRI: Oxaliplatin 85 mg/m2,irinotecan 180 mg/m2, folinic acid 400 mg/m2, 5'Fluouracilo 400 mg / m2, 5 'fluorouracil 2400 mg/m2 continuous intravenous infusion of 46 hours. Repeated every 14 days.
~FOLFOX: Oxaliplatin 85 mg/m2, folinic acid 400 mg/m2, 400 mg/m2 5'Fluouracilo, 2400 mg/m2 5'Fluouracilo continuous intravenous infusion of 46 hours. Repeated every 14 days.
~FOLFIRI: Irinotecan 180 mg/m2, folinic acid 400 mg/m2, 400 mg/m2 5'Fluouracilo intravenous bolus, 5'Fluouracilo 2400 mg / m2 continuous intravenous infusion for 46 hours. Repeated every 14 days."
16192339|NCT01454154|Drug|Glyburide|Administered as specified in the Treatment Arm.
16192340|NCT01454154|Drug|Placebo|Administered as specified in the Treatment Arm.
16192341|NCT01454141|Other|Cognitive Control Training|Three sessions of CCT.
16192342|NCT01454141|Other|Peripheral Vision Task|Three sessions of PVT.
16192343|NCT01454128|Behavioral|exercise|36 session supervised exercise intervention
16192344|NCT01454115|Drug|BMS-708163 (Gamma-Secretase Inhibitor)|Oral Solution, Oral, 0.3 mg, Once daily, once
16192345|NCT01454115|Drug|BMS-708163 (Gamma-Secretase Inhibitor)|Oral Solution, Oral, 1.5 mg, Once daily, once
16192346|NCT01454115|Drug|BMS-708163 (Gamma-Secretase Inhibitor)|Oral Solution, Oral, 5.0 mg, Once daily, once
16192347|NCT01454115|Drug|BMS-708163 (Gamma-Secretase Inhibitor)|Oral Solution, Oral, 15.0 mg, Once daily, once
16192348|NCT01454115|Drug|BMS-708163 (Gamma-Secretase Inhibitor)|Oral Solution, Oral, 50 mg, Once daily, once
16192349|NCT01454115|Drug|BMS-708163 (Gamma-Secretase Inhibitor)|Oral Solution, Oral, 100 mg, Once daily, once
16192350|NCT01454115|Drug|BMS-708163 (Gamma-Secretase Inhibitor)|Oral Solution, Oral, 200 mg, Once daily, once
16192351|NCT01454115|Drug|BMS-708163 (Gamma-Secretase Inhibitor)|Oral Solution, Oral, 400 mg, Once daily, once
16192352|NCT01454115|Drug|BMS-708163 (Gamma-Secretase Inhibitor)|Capsule, Oral, 50 mg, Once daily, once
16192353|NCT01454115|Drug|BMS-708163 (Gamma-Secretase Inhibitor)|Oral Solution, Oral, 800 mg, Once daily, once
16192354|NCT01454115|Drug|Placebo matching BMS-708163|Oral Solution, Oral, 0 mg, Once daily, once
16192355|NCT01454115|Drug|Placebo matching BMS-708163|Capsule, Oral, 0 mg, Once daily, once
16192356|NCT01454102|Biological|Nivolumab|
16192357|NCT01454102|Drug|Gemcitabine|
16192358|NCT01454102|Drug|Cisplatin|
16192359|NCT01454102|Drug|Pemetrexed|
16192360|NCT01454102|Drug|Paclitaxel|
16192361|NCT01454102|Drug|Carboplatin|
16192362|NCT01454102|Drug|Bevacizumab|
16192363|NCT01454102|Drug|Erlotinib|
16192364|NCT01454102|Biological|Ipilimumab|
16192365|NCT01454089|Drug|OGX-427 600 mg|Patients will receive three loading doses of 600 mg Study Drug within a 9-day period. Following the loading dose period, patients will receive weekly Study Drug infusions (600 mg IV) on Days 1, 8 and 15 of each 21-day cycle.
16192366|NCT01454089|Drug|OGX-427 1000 mg|Patients will receive three loading doses of 600 mg Study Drug within a 9-day period. Following the loading dose period, patients will receive weekly Study Drug infusions (1000 mg IV) on Days 1, 8 and 15 of each 21-day cycle.
16192367|NCT01454089|Drug|Placebo|Patients will receive three loading doses of placebo within a 9-day period. Following the loading dose period, patients will receive weekly placebo infusions (IV) on Days 1, 8 and 15 of each 21-day cycle.
16192368|NCT01454089|Drug|Gemcitabine|Patients will receive gemcitabine (1000 mg/m^2) for up to 6 cycles administered IV on Days 1 and 8 of each 21-day cycle following Study Drug infusion. The Cycle 1, Day 1 administration of chemotherapy must occur within 5 days of the third loading dose of Study Drug.
16192369|NCT01454089|Drug|Cisplatin|Following the administration of gemcitabine on Day 1, cisplatin (70 mg/m^2) will be administered IV for up to 6 cycles. The Cycle 1, Day 1 administration of chemotherapy must occur within 5 days of the third loading dose of Study Drug.
16192370|NCT01454089|Drug|Carboplatin|Following the administration of gemcitabine on Day 1, cisplatin (70 mg/m^2) is to be administered IV for up to 6 cycles; however, carboplatin could be substituted for cisplatin for some unacceptable toxicities. The Cycle 1, Day 1 administration of chemotherapy must occur within 5 days of the third loading dose of Study Drug.
16192371|NCT01454076|Drug|Ixazomib 2.5 mg|Ixazomib 2.5 mg Capsule B (Cycle 1 only)
16192372|NCT01454076|Drug|Ixazomib 4 mg Capsule A|Ixazomib 4 mg Capsule A (Cycle 1 only)
16192373|NCT01454076|Drug|Ixazomib 4 mg Capsule B|Ixazomib 4 mg Capsule B (Cycle 2 and beyond )
16192374|NCT01454076|Drug|Ketoconazole|Ketoconazole 400 mg tablets (Cycle 1 only)
16192375|NCT01454076|Drug|Rifampin|Rifampin 600 mg capsule (Cycle 1 only)
16192376|NCT01454076|Drug|Clarithromycin|Clarithromycin 500 mg tablets (Cycle 1 only)
16192377|NCT01454076|Drug|Ixazomib 4 mg Capsule B|Ixazomib 4 mg Capsule B (Cycle 1 and beyond)
16192378|NCT01454063|Drug|OMS302|OMS302 drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL solution containing 60.75 millimolar (mM) phenylephrine hydrochloride (HCl) and 11.25 mM ketorolac tromethamine formulated in a 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available balanced salt solution (BSS) through a syringe filter. This will achieve 4.0 mL of the drug product in a 500 mL bottle of BSS.
16192379|NCT01454063|Drug|Placebo|Placebo drug product will be supplied as a sterile, clear colorless liquid, free from particulates of foreign matter. Each vial contains a nominal 4.5 mL solution containing 20 mM sodium citrate buffer (pH 6.3 +/- 0.5). For administration to patients, 4.4 mL of the drug product is added to a 500 mL bottle of commercially available BSS through a syringe filter. This will achieve 4.0 mL of the drug product in a 500 mL bottle of BSS.
16192380|NCT01454037|Procedure|Prostate cryotherapy|cryoablate the prostate
16192381|NCT01454037|Procedure|Radical prostatectomy|Remove prostate
16192382|NCT01454037|Procedure|Radiation|Radiate prostate
16192383|NCT01454024|Device|FlexPen®|Prescribed insulin treatment delivered by FlexPen® as part of routine clinical practice
16192384|NCT01454024|Device|NovoPen® 3|Prescribed insulin treatment delivered by NovoPen® 3 as part of routine clinical practice
16192385|NCT01454011|Drug|Testosteron 250mg injection|The combination of 4 different testosterone esthers (30 mg testosterone propionate, 60 mg testosterone phenylpropionate, 60 mg testosterone isocaproate and 100 mg testosterone decanoate) injected in 3 weeks intervals.
16192386|NCT01454011|Drug|Testosterone 50mg transdermal application|Application of testosterone 50mg transdermal gel in every night
16192387|NCT01453998|Biological|Infanrix hexa|Single dose, licensed formulation, intramuscular into right thigh
16192388|NCT01453998|Biological|Prevenar 13|Single co-administered dose, intramuscular into left thigh
16192389|NCT01453998|Biological|GSK217744|Single dose, investigational formulation A or B, intramuscular into right thigh
16192390|NCT01453985|Procedure|Full-Thickness-Gastroplication|
16192391|NCT01453972|Behavioral|Long distanse moderate training|Moderate exercise
16192392|NCT01453972|Behavioral|Long interval training|High-intensity exercise, long duration
16192393|NCT01453972|Behavioral|Short interval training|High intensity exercise, short duration
16192394|NCT01453959|Drug|Fludrocortisone|Fludrocortisone in a dose of 0.4 mg/day for 7 days
16192395|NCT01453959|Other|Diet cycles|Two cycle of diets: low salt diet(40mEq Sodium/day by 7 days) and high salt diet (240mEq Sodium/day by 7 days)
16192396|NCT01453946|Drug|Entocort|Entocort capsules, taken orally, 6 mg daily.
16192397|NCT01453933|Drug|raltegravir|Switch of lopinavir/ritonavir to raltegravir 400 mg BID (duration 8 weeks)
16192398|NCT01453920|Drug|Ranibizumab|Intravitreal Ranibizumab 0.05cc (10mg/ml)
16192399|NCT01453920|Drug|Ranibizumab|Intravitreal Ranibizumab 0.05cc (10mg/ml)
16192400|NCT01453907|Drug|"ETI-204, Anthim"|intravenously, single dose
16192401|NCT01453907|Drug|placebo|intravenously, single dose
16192402|NCT01453894|Behavioral|Reminder and Outreach Intervention|This intervention includes (1) phone calls and text messages to remind participants that they are due for colorectal cancer (CRC) screening (2) mailed fecal occult blood test (FOBT) to participants so they can perform the test conveniently at home and mail them to the clinic, avoiding the need for a visit (3) plain language information and instructions to support understanding of CRC and FOBT use (4) a CRC screening coordinator to contact those still failing to complete testing by telephone or text (5) a feedback loop to patients regarding test results.
16192403|NCT01453881|Device|Spacer|Beclomethasone/Formoterol 100/6mcg pMDI 2 puffs two times/day with the aid of a Valved Holding Chamber - VORTEX
16192404|NCT01453881|Device|Comparator|Beclomethasone/Formoterol 100/6mcg pMDI 2 puffs two times/day without the aid of a Valved Holding Chamber - VORTEX
16192405|NCT01453868|Other|Non Impact Aerobics|a 12 week, twice a week class in non impact aerobics
16192406|NCT01453868|Other|Passive : lecture series|a 12 week, once a week for one hour lecture series with no exercise. Topics will cover symptom management in Multiple Sclerosis
16192407|NCT01453855|Drug|Travoprost ophthalmic solution, 0.003%|
16192408|NCT01453855|Drug|Travoprost ophthalmic solution, 0.004%|
16192409|NCT01453842|Dietary Supplement|Diet oil|Carrot and diet oil (containing 2-OG) and 1½ g of paracetamol
16192410|NCT01453842|Dietary Supplement|Olive oil|Carrot and olive oil and 1½ g of paracetamol
16192411|NCT01453842|Dietary Supplement|Carrot|Carrot and 1½ g of paracetamol
16192412|NCT01453829|Procedure|Harvesting and Isolation of Stem Cells|This will be an open-label, non-randomized multi-center patient sponsored study of ASC implantation using a catheter delivery system. ASCs will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The cells will be implanted into the Internal Carotid Artery and intravenously.
16192413|NCT01453816|Procedure|Harvesting and Isolation of Stem cells|Adipose-Derived Stem Cells (ASCs) will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The cells will be delivered via catheter into the renal artery and intravenously.
16192414|NCT01453803|Procedure|Harvesting and Implantation of Adipose-Derived Stem Cells|The adipose tissue specimen will be collected from the patient's abdomen or applicable region using a liposuction cannula. The adipose tissue is transferred to the laboratory for separation of the adipose tissue-derived stem cells, which are then transferred for catheter injection.
16192415|NCT01453790|Behavioral|Parent-Specific Depression Education and Motivation|Parent-specific written and verbal depression messages garnered from previous research were consolidated into a pamphlet and script, respectively. These are dispensed after randomization in the pediatric office. At two days, mothers in the experimental group receive a motivational telephone call.
16192416|NCT01453790|Behavioral|General Depression Education-Motivation|General depression education messages were compiled and are delivered verbally (scripted) and written (JAMA Depression Patient Page) after randomization in the pediatric office. At 2 days, mothers in the comparison group receive an attention control telephone call.
16192417|NCT01453777|Procedure|harvesting and implantation of adipose derived stem cells|Adipose-Derived Stem cells will be derived from the patient's fat tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells. The cells will be delivered via catheter into the internal carotid artery and intravenously.
16192418|NCT01453764|Procedure|Harvesting and Implantation of SVF|The cell therapy in this study is composed of stem cells derived from a patient's own adipose tissue that are harvested by liposuction using tumescent technique and isolated in the laboratory. The Adipose SVF will be delivered via intravenous injection.
16192419|NCT01453751|Procedure|Harvesting and Implantation of Adipose-Derived Stromal Vascular Fraction (AD-SVF)|ASCs will be derived from the patient's adipose-derived tissue. Liposuction using local anesthesia and syringe collection will be performed to collect the adipose tissue specimen for subsequent processing to isolate the stem cells.
16192420|NCT01453738|Biological|Ex- vivo cultured adult allogeneic MSCs|Single intraarticular dose of allogeneic MSCs suspended in 2ml Plasmalyte followed by 2ml of Hyaluronan
16192421|NCT01453738|Biological|Plasmalyte-A|Single intraarticular dose of 2ml Plasmalyte followed by 2ml Hyaluronan
16192422|NCT01453725|Biological|Golimumab|Golimumab 50 mg SC injection every 4 weeks
16192423|NCT01453725|Biological|Placebo|Placebo SC injection every 4 weeks
16192424|NCT01453712|Radiation|Control group|Conventional coronary CT angiography using standard reconstruction technique (filtered back projection).
16192425|NCT01453712|Radiation|Intervention group|Using the new scan protocol with 30 % less tube current and iterative image reconstruction algorithm.
16192426|NCT01453686|Drug|Hydrocortisone 1%|Topical cream, used twice daily for 6 weeks on affected area, followed by 6 weeks of no treatment, followed by an additional 6 weeks of the same intervention.
16192427|NCT01453686|Drug|Clobetasol Propionate 0.05%|Topical cream, used twice daily for 6 weeks on affected area, followed by 6 weeks of no treatment, followed by an additional 6 weeks of the same intervention.
16192428|NCT01453660|Other|Endo-PAT2000 testing|Endo-PAT2000 testing is done six times during the study. Baseline Assessment Time 1 Cycle 1, Day 1 (Pre-chemotherapy)Time 2 Cycle 1, Day 1 (After 1st dose of cisplatin), Time 3 Cycle 1, Day 2 (Before second cisplatin dose of cycle 1), Time 4 Cycle 1, Day 5 (After last cisplatin dose of cycle 1), End-of-Study Assessment Time 5 (14-34 weeks from Time 1; e.g., 1-12 weeks following completion of the last cycle of first-line chemotherapy) Long-Term Follow Up Assessment Time 6 (24-30 months from Time 1)
16192429|NCT01453660|Other|Endo-PAT2000 testing|Time 1: A baseline assessment will be performed in the fasting state including Endo-PAT2000, vital signs, waist circumference, fasting blood draw, & urine sample. This will be considered Day 1 of the study for this group of patients. Time 2 (2-5 hours from Time 1): Two to five hours after Time 1, patients will undergo assessment of blood pressure & heart rate, including orthostatics & Endo-PAT2000 testing. Time 5 -- End of Study visit (14-34 weeks from Time 1): At a time point 14 to 34 weeks later than Time 1 patients will undergo study testing in the fasting state. This includes Endo-PAT2000 testing, vital signs including orthostatics, waist circumference, fasting blood draw, & urine sample. The Surgery-Only Group will not have any assessment at Time 3 (Day 2) or Time 4 (Day 5) due to logistical concerns. Long-Term Follow Up Assessment Time 6 (24-30 months following Time 1)
16192430|NCT01453647|Other|Guided Imagery|The intervention consists of three audio-recorded guided imagery scripts formatted as three separate tracks on one CD. Each track is 30 minutes in length and is to be used in a recommended order for the first 6 weeks of the intervention and then used in any order for the follow-up weeks, 7 through 10. Project participants will be instructed to use each CD track, as prescribed, a minimum of once daily. CD Track 1 is a basic relaxation entrainment script; CD track 2 is a pleasant scene imagery script; CD track 3 is a well body imagery script.
16192431|NCT01453634|Drug|Lunacalcipol 180|4 subjects are planned to receive a total of 11 doses of the study drug given three times per week (tiw) over 24 days (day 1 to day 24), administered not more often than every other day.
16192432|NCT01453634|Drug|Lunicalcipol 270|8 subjects are planned to receive a total of 11 doses of the study drug given three times per week (tiw) over 24 days (day 1 to day 24), administered not more often than every other day.
16192433|NCT01453621|Other|Computerized clinical decision support|Intervention sites will receive decision support regarding whether patient meets very low risk criteria for clinically-important traumatic brain injury based on the PECARN prediction rules.
16192434|NCT01453608|Drug|Ferinject (ferric carboxymaltose)|Subjects will receive Ferinject (ferric carboxymaltose) intravenously on Day 0
16192435|NCT01453608|Drug|Placebo (saline)|Subjects will receive Placebo (saline) intravenously on Day 0
16192436|NCT01453595|Drug|BEZ235|"BEZ235 will be taken orally twice daily starting on Day 1, Cycle 1, self-administration will continue twice daily on a continuous schedule with cycle length defined as 28 days. Increasing dosing levels of BEZ235 will be studied sequentially (beginning with Dose Level 1, BEZ235 400mg by mouth twice daily) as per the treatment noted below.
~Cohort-1a BEZ235 300 mg by mouth twice daily Cohort 1 BEZ235 400 mg by mouth twice daily Cohort 2 BEZ235 600 mg by mouth twice daily Cohort 3 BEZ235 800 mg by mouth twice daily"
16192437|NCT01453582|Drug|Total Flavonoids of Propolis dropping pill|One pack contains 30 pills, weight 33g. One pack each time, three times a day, 14 days a course.
16192438|NCT01453582|Drug|total Flavonoids of Propolis dropping pill|One pack contains 30 pills, weight 33g. One pack each time, three times a day, 14 days a course.
16192439|NCT01453569|Drug|Sodium oligo-mannurarate 600mg|sodium oligo-mannurarate capsule 600mg twice a day for 24 weeks
16192440|NCT01453569|Drug|Sodium oligo-mannurarate 900mg|sodium oligo-mannurarate capsule 900mg twice a day for 24 weeks
16192441|NCT01453569|Drug|Placebo|simulant of sodium oligo-mannurarate capsule
16192442|NCT01453556|Procedure|Laparoscopic right colectomy|Laparoscopic right colectomy with mechanical ileo-colon anastomosis L-L
16192443|NCT01453543|Other|deep transverse friction massage|For the application of the deep transverse friction massage, the participants were positioned supine with the ankle in 90 ° of dorsiflexion, in order to bring some tension on the tendon. The treating clinician stabilized the subject's foot with one hand while applying the DTF with the other hand. The deep friction massage is a pinching technique with thumb and index finger, reinforced by the middle finger.
16192444|NCT01453530|Drug|Sugammadex|A single dose of sugammadex 2 mg/kg iv
16192445|NCT01453530|Drug|Neostigmine/Glycopyrrolate|A single dose of neostigmine 0.04 mg/kg iv plus glycopyrrolate 0.01 mg/kg iv
16192447|NCT01453517|Behavioral|Behavioral intervention for regain after bariatric surgery|6 week intervention targeting dietary behavioral adherence, stress management, and distress tolerance skills to prevent weight regain
16192448|NCT01453504|Drug|DHAP|Dexamethasone, Cytarabine, Cisplatin
16192449|NCT01453504|Drug|Everolimus|
16192450|NCT01453491|Drug|SRT2104|SRT2104 drug substance is a new chemical entity which is supplied as a fine, yellowish/amber powder. The SRT2104 investigational product is prepared by packing 25mg or 250 mg of micronized SRT2104 powder with no additional additives into a size 00 opaque, hard gelatin capsule. All subjects will be provided with one dosing bottle per day that contains two 25 mg or 250 mg SRT2104 capsules for oral ingestion.
16192451|NCT01453478|Drug|GSK1325756|CXCR2 antagonist
16192452|NCT01453465|Other|Laboratory Biomarker Analysis|Correlative studies
16192453|NCT01453452|Behavioral|behavioral dietary intervention|Reduce caloric intake by 500 kcal/day, increase fruit and vegetable intake to 5 or more servings per day, and limit daily calories from fat to be < 30%. Diet will be measured using 3 repeated 24-hr diet recalls. Participants will receive information on the recommended dietary modifications via mailed materials and telephone counseling sessions.
16192454|NCT01453452|Behavioral|exercise intervention|150 min/wk of moderate exercise through use of the Curves® centers, engage in physical activity outside of Curves®, and use pedometers to track activity.
16192455|NCT01453452|Other|counseling intervention|14 40-min behavioral counseling sessions via telephone with the goal of increasing intervention adherence and increasing participant retention.
16192456|NCT01453452|Procedure|quality-of-life assessment|PROMIS-43 - online questionnaire to assess quality of life.
16192457|NCT01453439|Behavioral|Cognitive Behavioral Therapy|Participants will receive a total of 22 sessions (over 24 weeks) of individual, manual-based CBT. During the sessions, participants will receive education about BDD and CBT, learn to develop more helpful thoughts and beliefs, gradually enter anxiety provoking situations while reducing compulsions (repetitive behaviors), and learn relapse prevention techniques.
16192458|NCT01453439|Behavioral|Supportive Psychotherapy|Participants will receive a total of 22 sessions (over 24 weeks) of individual, manual-based SPT. During the sessions, participants will receive education about BDD and SPT, learn about factors that may affect their symptoms (for example, relationships, work, stress), and learn to cope with challenges in their life by improving self-esteem and positive coping skills.
16192459|NCT01453426|Drug|BG00012 Dose 1|
16192460|NCT01453426|Drug|BG00012 Dose 2|
16192461|NCT01453413|Other|Blood Glucose meter|Staff tested subject Blood Glucose using a Blood Glucose meter.
16192462|NCT01453400|Drug|Acetylsalicylic Acid (Aspirin, BAY1019036) + placebo|Single dose, 2 x 500 mg fast release aspirin tablets (1000 mg) + 2 x placebo acetaminophen caplets
16192463|NCT01453400|Drug|Acetaminophen + placebo|Single dose, 2 x 500 mg Acetaminophen caplets (1000 mg) + 2 x placebo fast release Aspirin tablets
16192464|NCT01453400|Drug|Placebo|Single dose, 2 x placebo Acetaminophen caplets + 2 x placebo fast release Aspirin tablets
16192465|NCT01453387|Drug|MSC2015103B|Schedule 1: MSC2015103B will be administered orally once weekly on Days 1, 8, and 15 of a 21-day cycle until MTD establishment. Starting dose will be 150 microgram (mcg), which will be escalated to 200 mcg, 300 mcg, 450 mcg, 650 mcg, 1000 mcg and 1500 mcg subsequently.
16192466|NCT01453387|Drug|MSC2015103B|Schedule 2: MSC2015103B will be administered orally thrice weekly on Days 1, 3, 5, 8, 10, 12, 15, 17 and 19 of a 21-day cycle until MTD was established. Starting dose will be 150 mcg, and will be escalated to 200 mcg subsequently.
16192467|NCT01453374|Drug|VIVITROL 380mg|380 mg IM injection given once monthly
16192468|NCT01453361|Biological|Vigil™ Vaccine|
16192469|NCT01453348|Biological|MenACWY-CRM|Novartis meningococcal ACWY conjugate vaccine will be administered intramuscularly (IM) on day 1.
16192470|NCT01453348|Biological|Combined inactivated hepatitis A & recombinant hepatitis B|Combined inactivated hepatitis A and recombinant hepatitis B vaccine will be administered by IM on days 1, 8 & 29 for subjects unprimed with hepatitis A and B; and a single booster injection on day 1 for primed subjects.
16192471|NCT01453348|Biological|Recombinant hepatitis B vaccine|Recombinant hepatitis B vaccine will be administered intramuscularly on days 8 and 29
16192472|NCT01453348|Biological|Inactivated hepatitis A vaccine|Inactivated hepatitis A will be administered intramuscularly on days 8 and 29.
16192473|NCT01453309|Procedure|Cell Saver|Cell Savers are used intraoperatively to decrease the risk of transfusion due to surgical blood loss. Blood collected from the operative field is anticoagulated, filtered, and stored in a reservoir. Once a set volume of blood has been collected in the reservoir, the blood is separated into its red blood cell and plasma components by use of a centrifuge. Red blood cells are washed with a crystalloid solution and then reinfused into the patient.
16192474|NCT01453309|Procedure|No Cell Saver|Cell Saver will not be available during surgery
16192475|NCT01453296|Drug|GW642444|GW642444 25 μg; Novel dry powder inhaler
16192476|NCT01453296|Drug|Placebo|Matching placebo; Novel dry powder inhaler
16192477|NCT01453283|Drug|Trabectedin (ecteinascidin-743, ET-743, YONDELIS [R])|
16192478|NCT01453270|Device|NICOM|Assessment of fluid responsiveness will be done using the non-invasive cardiac output monitor (NICOM) and passive leg-raising (PLR) maneuver to target mean arterial pressure of between 65mmHg and 90mmHg; and change in stroke volume index (SVI) less than 10%, prior to administration of fluid boluses.
16192479|NCT01453270|Other|Usual care|Usual care is given at the clinician's discretion in accordance with current best practice. Standard treatment may involve treatment with intravenous fluids, and medications to support the blood pressure and heart.
16192480|NCT01453257|Drug|Tailored Chemotherapy|"Patients will be treated with Folfox, Folfiri, Xelox or Xeliri and Cetuximab or Bevacizumab at usual doses tailored by:
~K-ras native: Cetuximab. K-ras mutated: Bevacizumab Topoisomera 1 positive ( Topo-1): Irinotecan Topo-1 positive and ERCC-1 negative: oxaliplatin Topo-1 1 negative and ERCC-1 positive: investigator option Thimidylate synthase (TS) positive: No Fluoropyrimidines (FLP) TS negative: FLP Thimidylate phosphorylasa (TP) positive: Capecitabine TP negative: 5-FU"
16192481|NCT01453231|Procedure|thighplasty|Plastic surgery of thigh
16192482|NCT01453218|Drug|ATeGe-Fresenius|Administered at 1 , 3, 5 and 7 day post-transplant at 2-3mg/kg with dose adjustment according to CD2/CD3 levels
16192503|NCT01453114|Behavioral|Cognitive Behavioral Therapy|CBT is administered for 12 sessions over the period of 16 weeks, followed by optional monthly sessions.
16192483|NCT01453205|Drug|MEDI-551 2 mg/kg|MEDI-551 at the assigned dose will be administered via Intravenous (IV) infusion. Subjects will receive 3 cycles of M-ICE or M-DHAP unless CR is achieved at the end of Cycle 2, disease progression is noted at the end of Cycle 2, or a significant/serious drug related toxicity occurs (as per the opinion of the investigator).
16192484|NCT01453205|Drug|Rituximab|Rituximab at 375 mg/m2 will be administered via IV infusion 2 days before the start of Cycle 1 and on Day 1 of each cycle. The infusion time for rituximab will be 50 400 mg/hr, depending on subject's tolerance. Subjects will receive 3 cycles of Rituximab with Ice (R ICE) or Rituximab with DHAP (R-DHAP) unless CR is achieved at the end of Cycle 2, disease progression is noted at the end of Cycle 2, or a significant/serious drug related toxicity occurs (as per the opinion of the investigator).
16192485|NCT01453205|Drug|ICE|ICE will be administered via IV infusion as follows: ifosfamide 5 g/m2 continuously for 24 hours with mesna on Days 2 and 3; carboplatin AUC=5 mg/mL x min [800 mg maximum) on Day 2; etoposide 100 mg/m2 on Days 1, 2, and 3) in 21-day cycles.
16192486|NCT01453205|Drug|DHAP|DHAP will be administered via IV infusion as follows: dexamethasone 40 mg on Days 1, 2, 3, and 4; cisplatin 100 mg/m2 continuously for 24 hours on Day 1 of dosing cycle; cytarabine 2 g/m2 in 3-hour infusion repeated after 12 hours (2 doses) on Day 2 in 21-day cycles.
16192487|NCT01453205|Procedure|Autologous Stem Cell Transplant (ASCT)|Subjects who achieve CR or PR will undergo stem cell harvest and autologous stem cell transplantation (ASCT) following standard institutional protocols.
16192488|NCT01453205|Drug|MEDI-551 4 mg/kg|MEDI-551 at the assigned dose will be administered via Intravenous (IV) infusion. Subjects will receive 3 cycles of M-ICE or M-DHAP unless CR is achieved at the end of Cycle 2, disease progression is noted at the end of Cycle 2, or a significant/serious drug related toxicity occurs (as per the opinion of the investigator).
16192489|NCT01453192|Drug|Raltegravir|Introduction of Raltegravir 2 days after renal transplantation within an antiretroviral regimen without ritonavir boosted antiprotease
16192490|NCT01453179|Drug|Imiquimod|One course of treatment (COT) consisting of an overnight application of IMIQ (1 sachet for up to 50 cm2), applied 3 nights per week (e.g. Monday, Wednesday, Friday) for 4 weeks followed by a 4 weeks treatment pause. If necessary, this may be followed by a second COT.
16192491|NCT01453179|Drug|Diclofenac|Solaraze® is applied locally to the skin 2 times daily and smoothed into the skin gently. The amount needed depends on the size of the lesion. Normally 0.5 grams (the size of a pea) of the gel is used on a 25 cm2 lesion site. The duration of therapy is 12 weeks.
16192492|NCT01453166|Other|Brazilian heart-prevent meal|Nutrient profile of the diets used was based on the Brazilian guidelines to cardiovascular disease treatment.The main difference between this group involves a Brazilian version of accessible and energy density concept dietary therapy to cardiovascular diseases. Furthermore, it explores a set of tools and educational materials that help the patient understand and follow the principles of balanced and healthy diet weekly session with the dietitians which could be in person, by phone or in a gourmet shop. During attendances at the gourmet shop, patients received tips for eating in restaurants, instruction on label reading and a list of typical foods. The menus were based on typical foods consumed in Brazil, all foods included in the menu were low-cost and widely available at local markets
16192493|NCT01453166|Other|Heart prevent control meal weekly|received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts). The difference between groups B and C was the number of sessions with the dietician. Group B received weekly sessions, which could be in person or by phone, and group C had monthly in person sessions
16192494|NCT01453166|Other|Heart prevent control Meal monthly|received the usual dietary therapy to patients with cardiovascular diseases, which had the same nutrient profile as presented in Group A and B, but customized by the integration of mediterranean typical foods (e.g. olive oil and nuts) at the same of group B. The difference of group C was the number of sessions with the dietician. That happen monthly in person sessions.
16192495|NCT01453153|Drug|Gemcitabine|1000 mg/m2 given IV one time a week (Cycle 1: 7 weeks on treatment, 1 week off treatment; Cycle 2+: 3 Weeks on treatment, 1 week off treatment)
16192496|NCT01453153|Drug|PEGPH20|(Cycle 1: 7 weeks on treatment/1 week off treatment; Cycle 2+: 3 Weeks on treatment/1 week off treatment). Doses start at 1.0 mcg/kg and modified until recommended Phase 2 dose is determined. Treatment continues until occurrence of significant treatment-related toxicity, progressive disease, or discontinuation criteria are met
16192497|NCT01453153|Drug|Placebo|(Cycle 1: 7 weeks on treatment/1 week off treatment; Cycle 2+: 3 Weeks on treatment/1 week off treatment).
16192498|NCT01453140|Drug|Cyclophospahmide and Sirolimus|"On the first day of treatment, cyclophosphamide will be administered at a dose of 4g/m2 IV x 1 dose. Patients who are >40% above ideal weight will be dosed based on adjusted weight and adjusted BSA.
~One day after the administration of cyclophosphamide, patients will receive sirolimus 6 mg PO x 1 and on the following day will start sirolimus at a dose of 2 mg PO daily."
16192499|NCT01453140|Drug|Low dose IL-2, Cyclophosphamide and Sirolimus|"Patients in treatment arm B will be receiving low-dose IL-2 in conjunction with the cyclophosphamide and sirolimus.
~IL-2 will be administered at a dose of 0.5E6 IU/m2 SQ daily x 8 weeks followed by 4 weeks off, starting 14 days after the cyclophosphamide."
16192500|NCT01453140|Drug|Low dose IL-2, low dose Vidaza, cyclophosphamide & Sirolimus|"Patients in treatment arm C will be receiving low-dose azacitidine (Vidaza). The Vidaza will be initiated between day 27 and 32 following the cyclophosphamide.
~The dose administered will be 10 mg SQ daily for 5 days followed by 3 weeks off."
16192501|NCT01453127|Drug|I-123 Ioflupane solution injection prior to SPECT scan (DaTscan)|I-123 Ioflupane solution for injection into a living test subject. The iodine introduced during manufacture is a radioactive isotope, I-123, and it is the properties of this isotope that makes the solution visible to a gamma camera on SPECT imaging. I-123 has a half-life of approximately 13 hours and a gamma photon energy of 159 keV making it an good radionuclide for medical imaging. DaTscan is administered by intravenous cannula. The scan is carried out 3-6 hours post injection.
16192502|NCT01453127|Device|Single photon emission computed tomography (SPECT) scan|Single-photon emission computed tomography(SPECT)is a nuclear medicine tomographic imaging technique using gamma rays. It is very similar to conventional nuclear medicine planar imaging using a gamma camera. However, it is able to provide true 3D information. This information is typically presented as cross-sectional slices through the patient, but can be freely reformatted or manipulated as required.
16196192|NCT01424982|Drug|Vincristine|Given IV
16192504|NCT01453101|Drug|Fludarabine monophosphate, melphalan, Bortezomib|"Fludarabine will be administered at a dose of 30/mg/m2 IV daily for 4 days starting on transplant day -5.
~Melphalan will be administered at a dose of 140 mg/m2 on transplant day-2
~Bortezomib will be administered by rapid IV push at a dose of 1.6mg/m2 on days-4 and -1. The bortezomib should be given at least 20 hours after the melphalan."
16192505|NCT01453088|Drug|Melphalan|"Melphalan is administered at a dose of 200mg/m2 by rapid intravenous infusion via a central or peripheral vein over 30 minutes to one hour.
~Melphalan will be given as a single dose (not split over 2 or more days) and given on day-1.
~Dosing will be based on body surface area calculated using actual body weight
~Stem cell infusion:
~Stem cell infusion will occur on day 0 and will be at least 20 hours after the infusion of melphalan. The infusion of peripheral blood stem cells will be done in accordance with the Blood and Marrow Transplant program standard operating procedures.
~Filgrastim will be administered at a dose of 5 mcg/kg (rounded to vial size) every other day starting on day+3 then daily starting on day 9 until engraftment (at least)."
16192506|NCT01453088|Drug|Bortezomib|"Bortezomib:
~Bortezomib is administered by rapid I.V. push (over 3-5 seconds) via a central or peripheral vein into a flowing saline line. Bortezomib will be administered any time on day -4 and at least 20 hrs after the start of the melphalan infusion on day -1."
16192507|NCT01453075|Drug|Valacyclovir|Valacyclovir 1.5 mg po bid
16192508|NCT01453075|Drug|Placebo|Matching placebo twice daily
16192509|NCT01453062|Drug|Arzerra|Treatment with Arzerra
16192510|NCT01453049|Drug|rosiglitazone/glimepiride fix dose combination|oral, once daily, dosage is titrated according to FPG and hypoglycemia events
16192511|NCT01453049|Drug|glimepiride|oral, once daily, dosage is titrated according to FPG and hypoglycemia
16192512|NCT01453036|Procedure|23S rRNA point mutation test of Helicobacter pylori|mutation test group>> Helicobacter pylori polymerase chain reaction kit by dual-priming oligonucleotide-based multiplex polymerase chain reaction system before eradication of Helicobacter pylori at mutation test groupConventional Conventional AOC group, Conventional AOM group >> no intervention
16192513|NCT01453036|Procedure|UBT test & Gastroenterology with biopsy c silver stain|UBT test & Gastroenterology with biopsy c silver stain due to indentify H. pylori infection Conventional AOM group, Conventional AOC group, Mutation test group >> intervention
16192514|NCT01453023|Drug|Fluticasone Furoate|100mcg delivered via a novel dry powder inhaler on days 1-14 of one study treatment period.
16192515|NCT01453023|Drug|Fluticasone Furoate/Vilanterol|100/25 mcg delivered via a novel dry powder inhaler on days 1-14 of one study treatment period.
16192516|NCT01453010|Other|Self-directed Upper Limb SaeboFlex Training|"Participants undergo a 12 week self directed upper limb training programme with the SaeboFlex upper limb orthosis. Training consists of a maximum of 3 x 45 minute sessions a day.
~Participants are closely monitored at least once a week by a saebo-trained therapist."
16192517|NCT01452997|Drug|NSAI treatment|Ibuprofen 5% gel
16192518|NCT01452997|Drug|Steroid treatment|Steroid intervention with 0.05% w/w clobetasone butyrate.
16192519|NCT01452958|Biological|TNF-alpha|Study protocol 1: 6 ng/kg/h intraarterial Study protocol 2: 18 ng/kg/h intravenous
16192520|NCT01452958|Biological|Endotoxin|Study protocol 2:0,075 ng/kg/h intravenous
16192521|NCT01452932|Other|Physiotherapy|"The physiotherapeutic intervention was based on the Kabat (PNF) technique. Thirty-three sessions were planed. Each session lasted between thirty and fifty minutes.
~The experimental group was guided by a physiotherapist or a physiotherapy student and each session took place in a hospital auditorium provided with oxygen cylinders, chairs and water.
~Each session consisted of a warm up and stretch period, a period of resistance training of the upper limbs with their rest periods in which diaphragmatic breathing exercises and finally a cooling period.
~The instructions and instruments given to each participant such as weights and elastic bands were the same for all of them."
16192522|NCT01452932|Other|Yoga|"The intervention for the other group was the Yoga technique. Thirty-six sessions were planed. Each session was based on breathing, relaxation, and stretching exercises. Each session lasted between thirthy and forty minutes.
~The group was led by a Yoga Instructor and each sessions took place in a hospital auditorium provided by oxygen cylinders, chairs and water.
~No instruments were needed for this intervention."
16192523|NCT01452919|Drug|LY2140023|Administered orally
16192524|NCT01452919|Drug|Placebo|Administered orally
16192525|NCT01452906|Drug|PA21 and Omeprazole with food|The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Omeprazole will be 40 mg/day
16192526|NCT01452906|Drug|No PA21; Omeprazole with food|The maximum dosage of Omeprazole will be 40 mg/day
16192527|NCT01452906|Drug|PA21 with food, Omeprazole 2hrs later|The maximum dose of PA21 will be 15 g/day. The maximum dose of Omeprazole will be 40 mg/day
16192528|NCT01452893|Procedure|Spiroergometry|"At visit 1 determination of the individual VO2max (maximal oxygen uptake) by spiroergometry after first testing of cognitive function.
~At visit 2: Spiroergometry with 3 min warm up followed by 5 min 50% VO2max and 15 min at the individual respiratory compensation point (RCP)."
16192529|NCT01452880|Drug|Remifentanil|Remifentanil is an ultra-short-acting oppioid, which is quickly metabolized by unspecific blood and tissue esterases
16192530|NCT01452880|Drug|Remifentanil|GROUP A (N = 114): patients assigned to this group received Remifentanil at infusion rate of 0.05 mcg / kg / min I.V. ; GROUP B (N = 114): in this group Remifentanil was administered at infusion rate of 0,1 mcg / kg / min I.V. Remifentanil was administered intravenously throughout ESWL procedure.
16192531|NCT01452867|Device|Bag-Valve-Mask-Ventilation (Ambu Facemask)|Bag-Valve Mask-Ventilation
16192532|NCT01452867|Device|Laryngeal Mask (Laryngeal Mask Airway Supreme)|Ventilation
16192533|NCT01452867|Device|Laryngeal Tube (Laryngeal Tube LT-S-D (VBM))|Ventilation
16192534|NCT01452841|Other|Grapefruit|1.5 Rio Red Grapefruit consumed daily for 6 weeks
16192535|NCT01452841|Other|Control|Participants followed a diet low in bioactive rich fruits and vegetables and avoided citrus for six weeks
16192536|NCT01452828|Drug|TR-701 FA single infusion|Single IV infusion, 200 mg daily for 7 days
16192537|NCT01452828|Drug|TR-701 FA|Two separate infusions of 200 mg
16192538|NCT01452828|Drug|TR-701 FA|Single IV infusion, 200 mg daily for 7 days
16192539|NCT01452815|Drug|Placebo|Two #2 oval shaped,opaque-white, hard gelatin shell capsules containing inactive ingredients taken orally once daily for 12 weeks.
16192714|NCT01451619|Drug|Placebo for Laropiprant|One tablet orally once daily for 4 weeks
16192540|NCT01452815|Drug|10mg TZP-102|One 10mg #2 oval shaped, opaque-white, hard gelatin shell capsule containing active ingredients and one placebo capsule each taken orally once daily for 12 Weeks
16192541|NCT01452815|Drug|20mg TZP-102|Two 10mg #2 oval shaped, opaque-white, hard gelatin shell capsules containing active ingredients
16192542|NCT01452802|Device|HM II (HeartMate II LVAD)|The HM II pump contains a single moving component, the rotor. The pump is implanted just below the left hemidiaphragm with the inflow attached to the apex of the left ventricle and the outflow graft anastomosed to the ascending aorta. Blood is pumped continuously throughout the cardiac cycle from the left ventricle to the aorta.
16192543|NCT01452802|Drug|OMM (Optimal Medical Management)|Optimal medical management per established heart failure guidelines for this subject population including ACE inhibitors, beta blockers and aldosterone antagonists 45 out of the last 60 days or an inability to tolerate neurohormonal antagonists.
16192544|NCT01452789|Drug|sublingual buprenorphine|Initial daily dose: 15.9 mcg/kg/day; Initial unit dose: 5.3 mcg/kg q8 hours; Maximum daily dose: 60 mcg/kg/day; Up-titration rate: 25%; Weaning rate: 10%; Cessation Dose: Within 10 or 20% of starting dose
16192545|NCT01452789|Drug|oral morphine|Initial daily dose: 0.4 mg/kg/day; Initial unit dose: 0.07 mg/kg q 4 hours; Maximum daily dose: 1.25 mg/kg/day; Up-titration rate: 20%; Weaning rate: 10%; Cessation Dose: 0.025 mg/kg q 4 hours
16192546|NCT01452776|Drug|TAK-438|TAK-438 10 mg, tablets, orally, once daily for up to 52 weeks.
16192547|NCT01452776|Drug|TAK-438|TAK-438 20 mg, tablets, orally, once daily for up to 52 weeks.
16192548|NCT01452763|Drug|TAK-438|TAK-438 10 mg tablets, orally, once daily for up to 24 weeks.
16192549|NCT01452763|Drug|Placebo|Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
16192550|NCT01452763|Drug|TAK-438|TAK-438 20 mg tablets, orally, once daily for up to 24 weeks.
16192551|NCT01452763|Drug|Placebo|Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
16192552|NCT01452763|Drug|Lansoprazole|Lansoprazole 15 mg capsules, orally, once daily for up to 24 weeks.
16192553|NCT01452763|Drug|Placebo|TAK-438 placebo-matching tablets, orally, once daily for up to 24 weeks.
16192554|NCT01452750|Drug|TAK-438|TAK-438 10 mg tablets, orally, once daily for up to 24 weeks.
16192555|NCT01452750|Drug|Placebo|Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
16192556|NCT01452750|Drug|TAK-438|TAK-438 20 mg tablets, orally, once daily for up to 24 weeks.
16192557|NCT01452750|Drug|Placebo|Lansoprazole placebo-matching capsules, orally, once daily for up to 24 weeks.
16192558|NCT01452750|Drug|Lansoprazole|Lansoprazole 15 mg capsules, orally, once daily for up to 24 weeks.
16192559|NCT01452750|Drug|Placebo|TAK-438 placebo-matching tablets, orally, once daily for up to 24 weeks.
16192560|NCT01452737|Drug|Standard Bowel Prep|Subjects will be asked to take 4L of Golytely the day prior to procedure.
16192561|NCT01452737|Drug|2L Golytely/bisacodyl|Subjects will be asked to take 2L Golytely and 15mg bisacodyl the day prior to procedure.
16192562|NCT01452724|Drug|TAK-438|TAK-438 20 mg, tablets, orally, once daily for up to 6 weeks.
16192563|NCT01452724|Drug|Placebo|Lansoprazole placebo-matching capsules, orally, once daily for up to 6 weeks.
16192564|NCT01452724|Drug|Lansoprazole|Lansoprazole 30 mg, capsules, orally, once daily for up to 6 weeks.
16192565|NCT01452724|Drug|Placebo|TAK-438 placebo-matching tablets, orally, once daily for up to 6 weeks.
16192566|NCT01452711|Drug|TAK-438|TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.
16192567|NCT01452711|Drug|Placebo|Lansoprazole placebo-matching capsules, orally, once daily for up to 8 weeks.
16192568|NCT01452711|Drug|Lansoprazole|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
16192569|NCT01452711|Drug|Placebo|TAK-438 placebo-matching tablets, orally, once daily for up to 8 weeks.
16192570|NCT01452698|Drug|TAK-438|TAK-438 20 mg, tablets, orally, once daily for up to 8 weeks.
16192571|NCT01452698|Drug|Placebo|"Lansoprazole placebo-matching capsules, orally, once daily for up to 8 weeks.
~For participants whose EE is not endoscopically healed at Week 8, the participants will receive additional treatment of TAK-438 40 mg, tablets, orally, once daily for up to an additional 8 weeks."
16192572|NCT01452698|Drug|Lansoprazole|"Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
~For participants whose EE is not endoscopically healed at Week 8, the participants will receive additional treatment of TAK-438 40 mg, tablets, orally, once daily for up to an additional 8 weeks."
16192573|NCT01452698|Drug|Placebo|TAK-438 placebo-matching tablets, orally, once daily for up to 8 weeks.
16192574|NCT01452685|Drug|Placebo|TAK-385 placebo-matching tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
16192575|NCT01452685|Drug|TAK-385|TAK-385 10 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
16192576|NCT01452685|Drug|TAK-385|TAK-385 20 mg, tablets orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
16192577|NCT01452685|Drug|TAK-385|TAK-385 40 mg, tablets, orally, once daily and leuprorelin acetate placebo injection, subcutaneously, once every 4 weeks for up to 12 weeks.
16192578|NCT01452685|Drug|Leuprorelin acetate|TAK-385 placebo-matching tablets, orally, once daily and leuprorelin acetate 3.75 mg injection, subcutaneously, once every 4 weeks for up to 12 weeks
16192579|NCT01452672|Radiation|Radiotherapy|RT 40 Gy in 15 fractions
16192580|NCT01452672|Radiation|Irradiation of the chest-wall and supraclavicular fossa|RT 40Gy in 15 fractions
16192581|NCT01452659|Drug|TAK-385|TAK-385 10 mg, tablets, orally, once daily for up to 12 weeks.
16192582|NCT01452659|Drug|TAK-385|TAK-385 20 mg, tablets, orally, once daily for up to 12 weeks.
16192583|NCT01452659|Drug|TAK-385|TAK-385 40 mg, tablets, orally, once daily for up to 12 weeks.
16192584|NCT01452659|Drug|Placebo|TAK-385 placebo-matching tablets, orally, once daily for up to 12 weeks.
16192633|NCT01452295|Drug|ELAD (Extracorporeal Liver Assist System)|ELAD (Extracorporeal Liver Assist System)
16192667|NCT01451918|Drug|Resveratrol|500mg bid for one week followed by 1 gram bid for one week prior to lipoprotein study.
16192715|NCT01451606|Drug|Duloxetine|30 mg dose once daily, administered orally for 1 week, 60 mg dose once daily, administered orally for 5 weeks, 30 mg dose once daily, administered orally for 1 week
16192585|NCT01452646|Other|Risk-adapted, MRD-directed therapy|The general objective of this study is that of setting up a multicentre, risk-adapted study that relies on pre-treatment cytogenetic/genetic features and post-consolidation assessment of MRD to establish the final risk assignment and treatment of younger (≤ 60 years) patients with AML. Aim of this clinical trial is to verify whether the delivery of a post remission therapy whose intensity is risk-driven will improve the outcome in terms of both increased anti-leukemic efficacy and reduced therapy-related toxicity.
16192586|NCT01452633|Drug|0.25% bupivicaine will be injected at the study port site prior to incision|Injection will precede the incision
16192587|NCT01452633|Drug|Saline will be injected at the study port site prior to incision|Injection will precede incision
16192588|NCT01452633|Drug|Saline will be in injected into the port site prior to closure|Saline will be injected into the port site prior to the closure without any preincisional intervention
16192589|NCT01452633|Drug|0.25% bupivicaine will be injected into the port site prior to closure|0.25% bupivicaine will be injected into the port site at closure without any preincisional intervention
16192590|NCT01452607|Drug|SPI-1005|200 mg Ebselen oral capsules (SPI-1005), single dose
16192591|NCT01452607|Drug|Placebo|0 mg Ebselen oral capsules (SPI-1000), single dose
16192592|NCT01452594|Drug|Diphenylcyclopropenone|Topical administration
16192593|NCT01452594|Drug|Placebo|Placebo
16192594|NCT01452581|Other|Red blood cell transfusion|Maximal 2 units of packed red blood cells given one at a time on the first postoperative day. Evaluation of primary outcome is done after administration of each unit.
16192595|NCT01452581|Drug|Voluven|Infusion of up to 2 x 280 ml colloid (6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride). 280 ml at a time. Evaluation of primary outcome after each intervention.
16192596|NCT01452568|Drug|Aspirin|150mg/daily for three months, starting day after surgery
16192597|NCT01452568|Drug|Warfarin|Warfarin daily dosage to obtain an INR in between 2,0 to 3,0. Started the day after surgery and continued for three months.
16192598|NCT01452555|Behavioral|Video or In-Person Presentation|Participants will be randomly assigned to an in person counseling session or will watch a HIV and HIV testing video
16192599|NCT01452542|Drug|Eliglustat, common blend proposed commercial formulation|All participants will receive a single oral 150-mg dose of the common blend proposed commercial formulation of eliglustat, administered as one 150-mg strength capsule (Treatment T), on 2 separate dosing occasions.
16192600|NCT01452542|Drug|Eliglustat, Phase 3 capsule formulation|All participants will receive a single oral 150-mg dose of the Phase 3 capsule formulation of eliglustat, administered as three 50-mg strength capsules (Treatment R), on 2 separate dosing occasions.
16192601|NCT01452529|Drug|Hydrocodone bitartrate q24h film-coated tablets|Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily
16192602|NCT01452529|Drug|Placebo to match hydrocodone bitartrate q24h tablets|Placebo to match hydrocodone bitartrate q24h film coated tablets 20 - 120 mg once daily
16192603|NCT01452516|Device|nanOss Bioactive Bone void filler|Instrumented posterolateral gutter fusions using nanOss Bioactive bone void filler
16192604|NCT01452516|Device|Interbody FCage|Lumbar fusion using interbody cages with autograft. This will be done in conjunction with the posterolatreal gutter fusion
16192605|NCT01452503|Device|Path Women's Condom|comparison between 3 types of female condoms
16192606|NCT01452503|Device|FC2 female condom|comparison between 3 types of female condoms
16192607|NCT01452503|Device|Reddy 6 female condom (V-Amour)|comparison between 3 types of female condoms
16192608|NCT01452490|Device|Diode Laser Treatment|Laser treatment once every 6 weeks, for a total of 4 treatment sessions
16192609|NCT01452477|Drug|tanshinone|tanshinone 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.
16192610|NCT01452477|Drug|tanshinone placebo|placebo 1.0g / time, 3 times / day orally, continuous treatment for 12 weeks.
16192611|NCT01452464|Biological|MenACWY-CRM|MenACYW-CRM vaccination received as part of routine clinical care and as registered in the vaccine records.
16192612|NCT01452451|Drug|HM11260C|1, 2, and 4 mg for 8 weekly subcutaneous injections for cohorts W1, W2 and W3. 8, 12 and 16 mg for 3 monthly subcutaneous injections for cohorts M1, M2 and M3
16192613|NCT01452451|Drug|Placebo|Placebo for 8 weekly subcutaneous injections for cohorts W1, W2 and W3. Placebo for 3 monthly subcutaneous injections for for cohorts M1, M2 and M3
16192614|NCT01452438|Biological|MenACWY-CRM|MenACYW-CRM vaccination received as part of routine clinical care and as registered in the vaccine records.
16192615|NCT01452425|Device|Tourniquet|Inflation of a tourniquet (pressure equal to the mean arterial pressure) obtaining a model of slight venous congestion and arterial hypoperfusion
16192616|NCT01452425|Device|INVOS assessment|Near Infraread spectroscopy, non invasive
16192617|NCT01452425|Device|EMG assessment|Electromyography, non invasive
16192618|NCT01452412|Drug|Sodium bicarbonate|0.4 mEq/kg/day ideal body weight to be taken once a day
16192619|NCT01452412|Drug|Placebo|To be taken on the same schedule as the active arm
16192620|NCT01452399|Procedure|Shave margins|Partial mastectomy with shave margins.
16192621|NCT01452399|Procedure|No Shave Margins|Partial mastectomy without shave margins.
16192622|NCT01452373|Drug|Placebo|Placebo DHEA capsules (2) + placebo acolbifene capsule (1); daily oral dosing for 12 weeks.
16192623|NCT01452373|Drug|DHEA and Acolbifene|DHEA capsules (2 x 50 mg) + acolbifene capsule (1 x 20 mg); daily oral dosing for 12 weeks.
16192624|NCT01452347|Drug|warfarin 1mg|comparator warfarin
16192625|NCT01452347|Drug|dabigatran etexilate intermediate dose|active treatment (medium)
16192626|NCT01452347|Drug|dabigatran etexilate low dose|active treatment (low)
16192627|NCT01452347|Drug|warfarin 5mg|comparator warfarin
16192628|NCT01452347|Drug|dabigatran etexilate high dose|active treatment (high)
16192629|NCT01452347|Drug|warfarin 3mg|comparator warfarin
16192630|NCT01452334|Biological|BMS-936559 (Anti PD-L1)|Injection for infusion, Intravenous (IV), 1, 3 or 10 mg/kg, Every 2 weeks, 48-96 weeks depending on response
16192631|NCT01452321|Procedure|repetitive transcranial magnetic stimulation (rTMS)|"20 daily sessions: each with 25 trains of 10 seconds at 5Hz, with a 20 second inter-train interval, at an intensity of 120% of motor threshold.
~Site: Left Dorsolateral Prefrontal Cortex"
16192632|NCT01452308|Biological|Simtuzumab|
16192770|NCT01451203|Drug|CZP|SC
16192634|NCT01452269|Behavioral|Deaf Weight Wise program|"Groups will consist of approximately 13 subjects who meet for 2 hours a week for 16 weeks. Group sessions will be offered at a variety of times and days of the week. A trained, deaf, ASL-fluent counselor will lead the sessions.
~Subjects will be asked to complete a food and physical activity diary. Each intervention session will include a weigh-in, group sharing/problem solving, discussion of a weight management topic, and goal setting/action planning for the next week. Periodically, each subject will receive a Personal Feedback Report. Subjects will be able to earn points for complying with various aspects of the program. Points can be redeemed for small prizes (i.e. water bottles).
~The maintenance phase consists of two meetings at the beginning of the 6-month maintenance period and three months later. This will consist of a weigh-in, review of self-monitored diet and physical activity, problem solving and goal setting/action planning for their long-term program."
16192635|NCT01452256|Drug|Desflurane|4-6 Vol %
16192636|NCT01452256|Drug|Propofol|TIVA to achieve BIS value of 40-60
16192637|NCT01452243|Drug|Vitamin D and calcium suplementation|The pharmacological intervention will be the daily administration of chewable tablets containing 800 IU of vitamin D and 1200 mg of calcium. They will be administered over 2 years during the months of November to April in order to avoid the influence of sunlight.
16192638|NCT01452230|Behavioral|Supervised physical activity|Supervised physical activity
16192639|NCT01452217|Drug|Secretin|Secretin 1 IU/kg over 3 min
16192640|NCT01452204|Other|Pulsed Electromagnetical Field and Exercise|G1: MT, three times per week lasting 30' each session. G2: placebo MT, 3 X week lasting 30'each session. After 3 weeks of application of MT, will begin a program of exercises.
16192641|NCT01452191|Behavioral|Injury Prevention Briefing Plus facilitation|Injury Prevention Briefing (IPB) to provide best evidence on what works to reduce house fire injuries, and activities to get the evidence into practice. This arm will receive facilitation to support the implementation of the information in the IPB
16192642|NCT01452191|Behavioral|Injury Prevention Briefing|Children's centres will receive the Injury Prevention Briefing only.
16192643|NCT01452152|Drug|clopidogrel|clopidogrel 75 mg/day plus aspirin 81-162 mg/day for one year
16192644|NCT01452152|Drug|prasugrel|Prasugrel 5-10 mg/day plus aspirin 81-162 mg/day for one year
16192645|NCT01452139|Genetic|Point-of-Care Genetic Testing|Point-of-Care Genetic Testing for Genetic Variants Linked to Adverse Outcomes with Clopidogrel (CYP2C19*2 & ABCB1 3435 TT)
16192646|NCT01452139|Drug|Prasugrel|Treatment of STEMI patients carrying at least one high risk genetic variant with prasugrel 10mg daily.
16192647|NCT01452126|Drug|Ropivacaine concentration|Single shot preoperative perineural injection of ropivacaine to achieve surgical anesthesia. The concentration of ropivacaine is lowered by 0.05% after every successful surgical anesthesia specific to that block and raised by 0.05% after every unsuccessful surgical anesthesia specific to that block
16192648|NCT01452113|Drug|Vildagliptin|one 50 mg tablet per os
16192649|NCT01452100|Drug|prednisone|Patients enrolled into the study will be treated with prednisone, 20 mg/day (if body weight <70 kg ; or 25mg/d if body weight >70 kg) for 1 month, then tapered to 12.5 mg/d (month 2) and 7.5 mg/d (month 3) and stop. In both groups, patients will be treated according to expert advice including use of statins (according to French Health Agency recommendation), a RAS inhibitor and supportive treatment (including nutrition, treatment of heart failure, and dialysis).
16192650|NCT01452100|Other|placebo|• Patients enrolled into the study will be treated with placebo, 20 mg/day (if body weight <70 kg ; or 25mg/d if body weight >70 kg) for 1 month, then tapered to 12.5 mg/d (month 2) and 7.5 mg/d (month 3) and stop. In both groups, patients will be treated according to expert advice including use of statins (according to French Health Agency recommendation), a RAS inhibitor and supportive treatment (including nutrition, treatment of heart failure, and dialysis).
16192651|NCT01452087|Other|Exercise|Subjects will exercise on a treadmill for 1 hour at moderate intensity (i.e., 90% of the exercise intensity found to elicit their ventilatory threshold during the preliminary testing, which is equivalent to approximately 60% of their maximal predicted heart rate).
16192652|NCT01452074|Other|Exercise Training|During the first 12 weeks of the study, subjects will adhere to an exercise training program while maintaining their original body weight. The exercise training program will entail the following: 40min/session, ~50% of their maximal aerobic capacity (approximately 100-110 beats per min), 5-6 days/week
16192653|NCT01452074|Other|Weight Loss with continued Exercise Training|After the first 12 weeks in the study, subjects will continue with the same exercise program, but then they will be placed on a reduced calorie diet until they lose exactly 10% of their original body weight
16192654|NCT01452035|Other|Exercise|single session of exercise
16192655|NCT01452022|Device|Inductigraft|Synthetic bone graft
16192656|NCT01452009|Drug|Travoprost Ophthalmic Solution, 0.004% (New Formulation)|Travoprost Ophthalmic Solution, 0.004% given one drop once daily
16192657|NCT01452009|Drug|TRAVATAN®|TRAVATAN® administered one drop once daily
16192658|NCT01451996|Drug|Claritin|Subject will be given 10mg Claritin tablet.
16192659|NCT01451970|Other|High Fat Diet|Subjects will adhere to their specific diet for four weeks. For both diet treatments, the diet will be a weight-maintaining diet, and the target nutrient composition for diets will be 55% carbohydrate, 30% fat, 15% protein. For the monounsaturated fat treatment (M diet) approximately 10% of all lipids ingested will be saturated. For the saturated fat treatment (S diet) approximately 40% of all lipids ingested will be saturated.
16192660|NCT01451957|Other|Exercise - caloric balance|90 min exercise on Day 1 with meals afterward resulting in caloric balance for the day (i.e.; extra kcals provided to account for energy expended during exercise)]
16192661|NCT01451957|Other|No Exercise - hyper-caloric diet|Subjects remain sedentary on Day 1 and they ingest meals that are identical to those ingested on the day they performed exercise (i.e.; more calories ingested than expended because no exercise performed).
16192662|NCT01451957|Other|No exercise - caloric balance|Subjects remain sedentary on Day 1 and they ingest a similar proportion of macronutrients however, the total calories ingested will be lower than the other two trials, resulting in caloric balance for the day.
16192663|NCT01451944|Behavioral|education|home asthma case management and education
16192664|NCT01451931|Other|Point-of-care Ultrasound|Perform ultrasonography in the ED (physician).
16192665|NCT01451931|Radiation|Radiology Ultrasound|Diagnostic ultrasound completed in the radiology department at time 0.
16192668|NCT01451905|Drug|Liraglutide|Victoza® is supplied in pens for injection containing 18 mg of the GLP-1 agonist liraglutide in 3 mL sterile water with disodiumphosphate and propylene glycol, and phenol for conservation (pH 8.15). Commercial pens will be used and the information given in the packaging will be applicable. The initial daily dose will be 0.6 mg for one week, 1.2 mg the following week and then 1.8 mg for the remaining treatment period. The injection is administered once daily in the morning. The maximal plasma concentration is reached 8-12 hours after subcutaneous injection. The half-life in plasma is approximately 13 hours. The duration of effect is 24 hours.
16192669|NCT01451905|Drug|Placebo|The placebo pens contain saline and are administered in the same way and volume as Victoza. The placebo pens are specially prepared for this study and will be used in the study only
16192670|NCT01451892|Other|Dance Therapy|overweight individuals participating in a patient education program for obese people combined with specific dance-therapy
16192671|NCT01451892|Other|patient education|overweight individuals participating in a patient education program
16192672|NCT01451879|Drug|Rituximab|Clinically prescribed immune modulation regimen dosage determined by local medical provider.
16192673|NCT01451879|Drug|Miglustat|Clinically prescribed immune modulation regimen dosage determined by local medical provider.
16192674|NCT01451866|Other|resistance training|hypertrophic resistance training
16192675|NCT01451866|Other|complex resistance training|complex resistance training with speed, excentric and power-endurance elements
16192676|NCT01451853|Drug|SPI-1005 Low Dose|"Oral capsules, 200 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
~Arms: Low Dose
~Other Names:
~200 mg Ebselen"
16192677|NCT01451853|Drug|SPI-1005 Middle Dose|Oral capsules, 400 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
16192678|NCT01451853|Drug|SPI-1005 High Dose|Oral capsules, 600 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
16192679|NCT01451853|Drug|Placebo|Oral capsules, 0 mg ebselen, twice daily, 3 days for each cycle of chemotherapy
16192680|NCT01451840|Drug|Remifentanil|Bolus dose of intravenous remifentanil 0.25 mcg/kg given once before emergence of general anesthesia
16192681|NCT01451840|Drug|Alkalinized lidocaine|Administration of alkalinized lidocaine in the endotracheal tube cuff
16192682|NCT01451827|Drug|Tolvaptan MR|50/80 mg capsules
16192683|NCT01451827|Drug|Tolvaptan IR|60/30 mg capsules
16192684|NCT01451827|Drug|Placebo|tablet
16192685|NCT01451814|Behavioral|Positive Psychotherapy for smoking cessation|6 sessions of individual behavioral smoking cessation counseling that incorporates techniques from Positive Psychotherapy to increase positive affect and reduce negative affect prior to and after quitting smoking. Intervention includes 8 weeks of transdermal nicotine patch.
16192686|NCT01451814|Drug|Nicotine polacrilex|8 weeks of nicotine patch
16192687|NCT01451814|Behavioral|Relaxation training|Instructions in progressive muscle relaxation
16192688|NCT01451814|Behavioral|Behavioral smoking cessation treatment|Counseling on techniques to manage triggers and avoid smoking
16192689|NCT01451801|Biological|Twinrix|"A total of 400 healthy volunteers receive a standard course of immunization with a combined hepatitis A and B vaccine (Twinrix®) at 0, 1, and 6 months.
~Twinrix ® Adult suspension for injection. 1 ml contains 720 ELISA units of hepatitis A virus antigen adsorbed to aluminum hydroxide and 20 micrograms hepatitis B surface antigen (HBsAg) adsorbed to aluminum phosphate in sterile water. Excipient: sodium chloride. Contains traces of neomycin."
16192690|NCT01451788|Device|Gelatin matrix with human derived thrombin (Floseal, Baxter)|Floseal will be used to stop cancellous bone bleeding, pedicle channel bleeding or epidural space bleeding by injecting suitable amount of this matrix and irrigating it away after few minutes.
16192691|NCT01451775|Drug|Empagliflozin|high dose of empagliflozin after overnight fasting for at least 10 h
16192692|NCT01451775|Drug|Empagliflozin|low dose empagliflozin after overnight fasting for at least 10 h
16192693|NCT01451775|Drug|Empagliflozin|high dose of empagliflozin after a standardised high fat breakfast
16192694|NCT01451762|Drug|.9 normal saline|.9 normal saline administered before surgery.
16192695|NCT01451762|Drug|25 mg diphenhydramine IV|25 mg diphenhydramine IV administered before surgery
16192696|NCT01451762|Drug|50 mg diphenhydramine IV|50 mg diphenhydramine administered IV before surgery
16192697|NCT01451749|Drug|Shenwu Capsule|"1 shenwu capsule contains 451 mg extract from herbs.5 capsules/time, 3 times/day for 6 months.
~Placebo identified to donepezil: 1 tablet per time, 1 time per day for 6 months."
16192698|NCT01451749|Drug|Donepezil|"This active drug is donepezil 5 mg tablet. 1 tablet/time, 1 time/day for 6 months.
~Placebo identical to shenwu capsules,5 capsules/time,3times/day for 6months."
16192701|NCT01451723|Drug|Polyphenon E|Polyphenon E is a standardized green tea extract. For this study we will use capsules of Polyphenon E containing 200 mg of EGCG per capsule. Subjects will take two capsules twice a day with food.
16192702|NCT01451723|Other|Placebo|Matching placebo capsules
16192703|NCT01451710|Drug|Prednisone or Prednisolone|daily single dose of 1mg/kg (maximum 80mg) or alternate day single dose of 2mg/kg (maximum 120mg),maintained for a minimum period of 6 weeks and maximum period of 12 weeks. After achieving complete remission., corticosteroids should be tapered slowly, 10mg every two weeks tapered to reach 0.15mg/kg/d, then 2.5mg every two to four weeks tapered to reach the minimum dosage 10mg/ alternate day
16192704|NCT01451697|Behavioral|Cognitive Remediation|A computerized cognitive remediation program focused on attentional training will be used.
16192705|NCT01451697|Behavioral|Control (Placebo)|The control condition will involve relaxation training.
16192706|NCT01451658|Drug|propranolol|Starting from 20 mg daily, titrated weekly to decrease heart rate more than 25 % of baseline, administrated during the whole study period
16192707|NCT01451645|Drug|Colchicine (Colcrys®)|daily 0.6 mg colchicine dosing for 16 weeks
16192708|NCT01451645|Drug|placebo|daily placebo dosing for 16 weeks
16192709|NCT01451645|Drug|allopurinol|background therapy
16192710|NCT01451632|Drug|MM-121|escalating doses MM-121 IV QW
16192711|NCT01451632|Drug|Irinotecan|180 mg/m2 IV Q2W
16192712|NCT01451632|Drug|Cetuximab|escalating doses cetuximab IV QW
16192713|NCT01451619|Drug|Laropiprant|One 100-mg tablet orally once daily for 4 weeks
16192716|NCT01451606|Drug|Placebo|To serve as placebo for duloxetine. Administration schedule same as for active drug.
16192717|NCT01451593|Drug|Phenytoin|Phenytoin will be loaded using at total dose of 15mg/kg (rounded to the nearest 100mg) divided into three equal doses given once daily for 3 days.This will be followed by a daily maintenance dose of 4mg/kg once a day (rounded up to the nearest 50mg, with a maximum dose of 300mg)for 13 weeks.Phenytoin levels will be taken at 1 and 3 months.
16192718|NCT01451593|Drug|Placebo|placebo identical in appearance to active IMP (phenytoin)
16192719|NCT01451580|Drug|Lipo-Dox|
16192720|NCT01451567|Behavioral|Ergonomic plan|participants in the intervention group were evaluated by the REBA and received an overall coaching that stretched over four meetings Each session paid special attention to, and included explanations about, the anatomy and physiology of body regions
16192721|NCT01451554|Behavioral|portion control plate|Individuals are provided with a portion control plate to use while eating and dietary counseling by dietician
16192722|NCT01451554|Behavioral|Usual Care|self-help booklets
16192723|NCT01451541|Drug|Ciclesonide nasal aerosol 37 mcg|ciclesonide nasal aerosol 37mcg - the dose is administered as 1 actuation per nostril to give a total dose of 37
16192724|NCT01451541|Drug|ciclesonide nasal aerosol 74 mcg|ciclesonide nasal aerosol 74 mcg - the dose is administered as 1 actuation per nostril to give a total dose of 74 mcg
16192725|NCT01451541|Drug|Placebo|Placebo - one dose per nostril
16192726|NCT01451528|Biological|Allogeneic Umbilical Cord Blood|Allogeneic Umbilical Cord Blood Transplantation via Intravenous or Intraarterial route
16192727|NCT01451515|Drug|Prednisone|Given orally (PO).
16192728|NCT01451515|Drug|Vincristine|Given intravenously (IV).
16192729|NCT01451515|Drug|Daunorubicin|Given IV.
16192730|NCT01451515|Drug|PEG-asparaginase|Given intramuscularly (IM) or IV.
16192731|NCT01451515|Drug|Erwinia asparaginase|Given IM or IV if allergy occurs with the first or second PEG-asparaginase dose.
16192732|NCT01451515|Drug|Doxorubicin|Given IV.
16192733|NCT01451515|Drug|Cyclophosphamide|Given IV.
16192734|NCT01451515|Drug|Cytarabine|Given IV or IT.
16192735|NCT01451515|Drug|Thioguanine|Given PO.
16192736|NCT01451515|Drug|Clofarabine|Given IV.
16192737|NCT01451515|Drug|Methotrexate|Given IV, IM or IT.
16192738|NCT01451515|Drug|Mercaptopurine|Given PO.
16192739|NCT01451515|Drug|Dexamethasone|Given PO or IV.
16192740|NCT01451515|Drug|Hydrocortisone|Given IT.
16192741|NCT01451515|Drug|Etoposide|Given IV.
16192742|NCT01451502|Biological|Umbilical Cord Blood (UCB)|Infusion of Minimally Manipulated UCB Units - the UCB unit will be infused through a central line according to institutional guidelines.
16192743|NCT01451489|Drug|FK506|FK506:0.05-0.1mg/kg/d
16192744|NCT01451489|Drug|Cyclophosphamide|CTX 750mg/m2 per month in the induction phase,then 750mg/m2 every 2 month for 3 times,then 750mg/m2 every 3 months.
16192745|NCT01451450|Drug|QGE031|QGE031 liquid for subcutaneous injection.
16192746|NCT01451450|Drug|Placebo|Placebo liquid for subcutaneous injection.
16192747|NCT01451437|Drug|MK-8242|MK-8242 capsules, orally, once per day on Days 1-7 and Days 15-21 of each 28-day cycle (except Cycle 1 Day 7) up to a maximum of 12 cycles. Starting dose will be 30 mg and will be escalated in successive cohorts until maximum tolerated dose (MTD) is established. Beginning at a dose level of ≥120 mg total daily dose (TDD), the dosing regimen will switch to twice daily (BID). Amendment 4 added a 21-day dosing cycle in which MK-8242 would be given BID on Days 1-7 of each cycle, at the assigned dose level.
16192748|NCT01451424|Drug|Proellex|vaginal suppository, daily, for 12 weeks
16192749|NCT01451411|Drug|Conivaptan hydrochloride|Intravenous
16192750|NCT01451411|Drug|Placebo|Intravenous
16192751|NCT01451398|Drug|Technosphere® Insulin|Technosphere® Insulin Inhalation Powder
16192752|NCT01451398|Drug|Technosphere Powder|Placebo Comparator
16192753|NCT01451385|Drug|COV795|COV795 is a multilayer extended-release tablet for oral administration of oxycodone hydrochloride (15 mg) and acetaminophen (650 mg)
16192754|NCT01451359|Device|EndoBronchial Valve|The implantable IBV™ device is a one-way valve, designed for placement in selected regions of the bronchial tree using a flexible bronchoscope.
16192755|NCT01451346|Dietary Supplement|B. Infantis 35624|One sachet daily for 12 weeks
16192756|NCT01451333|Drug|Efavirenz|600mg qd; 3 x 200mg qd
16192757|NCT01451333|Drug|Efavirenz|400mg qd; 2 x 200mg
16192758|NCT01451320|Drug|Streptokinase|3-hour infusion of 1.5 million units of streptokinase (16 patients, 16 episodes), repeat once 24 hours later if needed (maximum total dose 3 million units)
16192759|NCT01451320|Drug|Streptokinase|24-hour infusion of 1.5 million units of streptokinase (41 patients, 41 episodes), repeat once 24 hours later if needed (maximum total dose 3 million units).
16192760|NCT01451320|Drug|Tissue plasminogen activator|5-hour infusion of 90 mg t-PA (Tissue plasminogen activator) after 10 mg bolus (10 patients, 12 episodes), repeat once 24 hours later if needed (maximum total dose 200 mg)
16192761|NCT01451320|Drug|Tissue Plasminogen Activator|6-hour infusion of 50 mg t-PA (Tissue plasminogen activator) without bolus (27 patients, 27 episodes), repeat once 24 hours later up to 3 times if needed (maximum total dose 150 mg).
16192762|NCT01451320|Drug|Tissue Plasminogen Activator|6-hour infusion of 25 mg t-PA (Tissue plasminogen activator) without bolus (108 patients, 124 episodes), repeat once 24 hours later up to 6 times if needed (maximum total dose 150 mg).
16192763|NCT01451294|Drug|Administration of phenylephrine|Phenylephrine: 50-100µg
16192764|NCT01451294|Drug|Administration of ephedrine|Ephedrine: 5- 10 mg
16192765|NCT01451268|Drug|Panobinostat|10mg upto 40mg Panobinostat dose escalation in consequent cohorts; frequency: three times a week, every week; duration: one year
16192766|NCT01451268|Drug|Panobinostat|Start of Arm B after completion of Arm A; initial dose-level: one level below MTD of Arm A; 10mg upto 60mg Panobinostat dose escalation in consequent cohorts; frequency: three times a week, every other week; duration: one year
16192767|NCT01451242|Other|no intervention is made|no intervention is made
16192768|NCT01451229|Drug|higenamine|infused intravenously with higenamine at the escalating doses from 0.5 ug/kg/min through 1.0 ug/kg/min and 2.0 ug/kg/min to 4.0 ug/kg/min, each dose being given for 3 minutes
16192769|NCT01451203|Drug|Placebo|Subcutaneous (SC)
16192772|NCT01451190|Biological|Autologous cultured dermal and epidermal cells|A piece of occipital scalp is taken from the subject. A mixed population of dermal cells from this tissue are expanded in culture. The cells are then harvested. These cells are then injected into the balding area of the scalp of the original subject.
16192773|NCT01451177|Biological|Autologous cultured dermal and epidermal cells|A piece of occipital scalp, plucked of hairs prior to excision, is taken from the subject. The epidermal and dermal cells from this tissue are expanded in culture. The cells are then harvested and, for certain types of product, combined. The cells are then injected into the balding area of the scalp of the original subject.
16192774|NCT01451164|Drug|OPC-34712|orally administered once daily
16192775|NCT01451164|Drug|OPC-34712|orally administered once daily
16192776|NCT01451164|Drug|OPC-34712|orally administered once daily
16192777|NCT01451164|Drug|Placebo|orally administered once daily
16192778|NCT01451151|Biological|Autologous cultured dermal and epidermal cells|A piece of occipital scalp is taken from the subject. A mixed population of dermal cells from this tissue are expanded in culture. The cells are then harvested. These cells are then injected into the balding area of the scalp of the original subject.
16192779|NCT01451138|Biological|Autologous cultured dermal and epidermal cells|A piece of occipital scalp is taken from the subject. The epidermal and dermal cells from this tissue are expanded in culture. The cells are then harvested and, for certain types of product, combined. These cells are then injected into the balding area of the scalp of the original subject.
16192780|NCT01451125|Biological|Autologous cultured dermal and epidermal cells|A piece of occipital scalp is taken from the subject. The epidermal and dermal cells from this tissue are expanded in culture. The cells are then harvested and, for certain types of product, combined. These cells are then injected into the balding area of the scalp of the original subject.
16192781|NCT01451112|Biological|Autologous cultured dermal and epidermal cells|A piece of occipital scalp is taken from the subject. The epidermal and dermal cells from this tissue are expanded in culture. The cells are then harvested and, for certain types of product, combined. These cells are then injected into the balding area of the scalp of the original subject.
16192782|NCT01451099|Biological|Autologous cultured dermal cells|A piece of occipital scalp is taken from the subject. The dermal cells from this tissue are expanded in culture. The cells are then harvested. These cells are then injected into the balding area of the scalp of the original subject.
16192783|NCT01451086|Biological|vaccine made by Beijing Minhai Biotechnology Co., Ltd|Subjects receive 0.5 mL/dose of 23-valent pneumococcal polysaccharide vaccine by intramuscular (deltoid) injection on Day 0.
16192784|NCT01451086|Biological|vaccine made by Chengdu Institute of Biological Products|Subjects receive 0.5 mL/dose of 23-valent pneumococcal polysaccharide vaccine by intramuscular (deltoid) injection on Day 0.
16192785|NCT01451073|Biological|Autologous cultured dermal and epidermal cells|Two pieces of occipital scalp are taken from the subject, three weeks apart. The dermal and epidermal cells from these tissues are expanded in culture. The cells are then harvested and, for certain types of product, combined. On the day the cells are harvested after manufacture, they are then injected into the balding area of the scalp of the original subject within a certain time period.
16192786|NCT01451060|Drug|Metaraminol|It will be used a dose of 0.5 mg to any fall in blood pressure of the fetus until birth
16192787|NCT01451060|Drug|Ephedrine|It will be used at any one dose de1mg fall in blood pressure of the fetus until birth
16192788|NCT01451047|Biological|Autologous cultured dermal and epidermal cells|A piece of occipital scalp is taken from the subject. The epidermal and dermal cells from this tissue are expanded in culture. The cells are then harvested and, for certain types of product, combined. These cells are then injected into the balding area of the scalp of the original subject.
16192789|NCT01451034|Procedure|WHYX cancer group|WHYX cancer diagnosed by pathologic report
16192790|NCT01451021|Biological|Autologous cultured dermal and epidermal cells|A piece of occipital scalp is taken from the subject. The epidermal and dermal cells from this tissue are expanded in culture. The cells are then harvested and, for certain types of product, combined. These cells are then injected into the balding area of the scalp of the original subject.
16192791|NCT01451008|Device|Compression anastomotic ring-locking procedure (CARP)|The Compression anastomotic ring-locking procedure (CARP) device is based on a set of rings to make a compression anastomosis between the intestinal ends.
16192792|NCT01450995|Drug|Treximet|Tablet form, one tablet dose, one tablet at migraine onset with second tablet for persistent or recurring migraine two hours after first dose.
16192793|NCT01450995|Drug|Imitrex and two Aleve|Imitrex tablet, one tablet dose, Aleve tablets, 2 220 mg tablet dose. Three tablets taken concurrently with migraine onset. Second dose of tablets may be taken if migraine persists for two hours
16192794|NCT01450982|Drug|JNJ-38518168 / MTX|Day 1: MTX: Route=oral use, single dose of participant's weekly MTX dose
16192795|NCT01450956|Drug|Sevoflurane|Sevoflurane will be given at a concentration of 2% through oxygenator during CPB
16192796|NCT01450956|Other|Control|Patients will receive only oxygen and air through oxygenator
16192797|NCT01450943|Device|SECONDARY dressing gauze and tape|SECONDARY dressing gauze and tape
16192798|NCT01450943|Procedure|debridement, irrigation|debridement, irrigation
16192799|NCT01450943|Device|Dermagraft|Dermagraft per company protocol
16192800|NCT01450943|Device|Oasis|Oasis per company protocol
16192801|NCT01450930|Drug|Hydrocortisone intramuscular first|Hydrocortisone intramuscular first
16192802|NCT01450930|Drug|Hydrocortisone subcutaneously first|Hydrocortisone subcutaneously first
16192803|NCT01450904|Procedure|Quadriceps incision < 2 cm|MIS-TKA was performed with less than 2 cm Quadriceps incision length
16192804|NCT01450904|Procedure|Quadriceps incision 2-4 cm|MIS-TKA was performed with 2 to 4 cm Quadriceps incision length
16192805|NCT01450904|Procedure|Quadriceps incision > 4 cm|MIS-TKA was performed with more than 4 cm Quadriceps incision length
16192806|NCT01450878|Drug|beta-epoietin|100 000UI beta-epoietin injection one hour before organ retrieval
16192807|NCT01450865|Drug|flupirtine|Potassium channel opener (SNEPCO)
16192808|NCT01450852|Behavioral|Strength Training|Each Member of this group completed 12 weeks of progressive, periodized resistance training for 3d/wk.
16192882|NCT01450280|Biological|ChAd63, MVA CS|ChAd63 CS 5x10^10 vp intra-muscularly Day 0; MVA CS 2x10^8 pfu intra-muscularly Day 56
16192809|NCT01450839|Drug|E2022|The treatment period consists of 2 periods, Period I and Period II. In Period I, one 5 mg E2020 tablet will be administered in a single dose. In Period II, the tape containing 16 mg E2022 (which corresponds to one 5 mg E2020 tablet) will be applied repeatedly for 17 days. A washout period of at least 8 days will be allowed between the day of single dose administration in Period I and the first day of repeated application in Period II. A post-treatment examination will be performed at least 21 days after the last removal of the investigational product in Period II.
16192810|NCT01450839|Drug|Placebo|Matching Placebo tablets and tape
16192811|NCT01450826|Drug|aprepitant|On day 1, eligible patients will receive a single oral dose of Aprepitant 125 mg p.o, 1 hour before first dose of the 5-day oral temozolomide regimen. This will be followed by Aprepitant 80 mg p.o. on days 2 -5 (1 hour prior to temozolomide).
16192812|NCT01450826|Drug|ondansetron|On Days 1-5, eligible patients will receive a single oral dose of Ondansetron, 30 minutes before first dose of the 5 -day oral temozolomide regimen.
16192813|NCT01450813|Drug|Saline 0.06 ml/kg|IV Infusion x1 prior to laryngoscopy
16192814|NCT01450813|Drug|Rocuronium 0.2 mg/kg|IV Infusion x1 prior to laryngoscopy
16192815|NCT01450813|Drug|Rocuronium 0.4 mg/kg|IV Infusion x1 prior to laryngoscopy
16192816|NCT01450813|Drug|Rocuronium 0.6 mg/kg|IV Infusion x1 prior to laryngoscopy
16192817|NCT01450800|Drug|Nitrofurantoin|Nitrofurantoin 100mg po daily to be taken every day the patient uses a catheter for up to one week post-operatively
16192818|NCT01450800|Drug|Placebo|Participants randomized to placebo will be instructed to take placebo one tablet by mouth daily starting on postoperative day 1 for up to 7 days during catheterization
16192819|NCT01450774|Drug|CHF 1535 50/6µg|fixed combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg
16192820|NCT01450774|Drug|beclomethasone dipropionate 50µg + formoterol fumarate 6µg|free combination of beclomethasone dipropionate 50µg + formoterol fumarate 6µg
16192821|NCT01450761|Biological|Ipilimumab|
16192822|NCT01450761|Biological|Placebo matching Ipilimumab|
16192823|NCT01450761|Drug|Etoposide|
16192824|NCT01450761|Drug|Cisplatin|
16192825|NCT01450761|Drug|Carboplatin|
16192826|NCT01450748|Drug|Sodium alginate|oral suspension, 50 mg/ml, 20 ml three times daily, 8 weeks
16192827|NCT01450748|Drug|Placebo|matching placebo oral suspension, 50 mg/ml, 20 ml three times daily, 8 weeks
16192828|NCT01450735|Device|MANOS CTR™|The MANOS device is a carpal tunnel blade used to release the transverse carpal ligament in order to provide relief for Carpal Tunnel Syndrome.
16192829|NCT01450722|Procedure|bypass surgery, stent placement|bypass surgery, stent placement
16192830|NCT01450722|Procedure|stent placement|placement of paclitaxel eluting stent in long superficial femoral artery obstruction
16192831|NCT01450709|Dietary Supplement|Kibow Biotics|6 month, double-blind, cross-over, wash-out, placebo controlled study in an outpatient setting. Each patient takes two capsules, three times a day (180 CFU/day).
16192832|NCT01450696|Drug|Capecitabine|Capecitabine will be administered at a dose of 800 mg/m^2 orally twice daily for 14 days q3w for up to 6 cycles (Cycles 1 to 6).
16192833|NCT01450696|Drug|Cisplatin|Cisplatin will be administered at a dose of 80 mg/m^2 intravenously q3w on Day 1 of each 3-week cycle for up to 6 cycles (Cycles 1 to 6).
16192834|NCT01450696|Drug|Herceptin|Herceptin will be administered at a loading dose of 8 mg/kg on Day 1 of Cycle 1 followed by 6 or 10 mg/kg (depending upon treatment assignment) q3w from Day 1 of Cycle 2 until disease progression, occurrence of unacceptable toxicity, or withdrawal from the study for another reason.
16192835|NCT01450683|Drug|Itraconazole|"600 mg/day oral (PO)
~IUPAC name: (2R,4S)-rel-1-(Butan-2-yl)-4-{4-[4-(4-{[(2R,4S)-2-(2,4-dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy}phenyl)piperazin-1-yl]phenyl}-4,5-dihydro-1H-1,2,4-triazol-5-one"
16192836|NCT01450670|Dietary Supplement|Kibow Biotics|Month 1, one capsule three times daily (90 Colony forming units); Month 2, two capsules three times daily (180 CFU's); Month 3, three capsules three times daily (270 CFU's). Continued on tolerated maintenance dosage for an additional 6 months. Once tolerated dosage is identified the patient will be continued on that maintenance dosage for an additional 6 months. All medical, physical, clinical, QOL and other parameters will be monitored as well.
16192837|NCT01450657|Dietary Supplement|Kibow Biotics/Renadyl|Month 1, one capsule three times daily (90 colony forming units); Month 2, two capsules three times daily (180 CFU's); Month 3 & 4, three capsules three times daily (270 CFU's). Months 5 & 6 are washout periods, in which the patient receives no product. All parameters are still monitored by the study site during months 5 & 6. All medical, physical, clinical, QOL and other parameters will be monitored as well.
16192838|NCT01450644|Other|The Hospital2Home Service|This intervention is a new multiprofessional, patient case conference that is organised for people nearing the end-of-life. Evidenced based guidelines for the management of the physical, psychological, spiritual and end of life-planning needs for these patients will be used in the H2H case conference. A case conference will be organised in their home (or place of their choice). The patient, informal caregiver, H2H CNS, GP, district nurse, social worker and community palliative care nurse are invited to attend. Current and anticipated care needs are discussed, and an action plan is agreed allocating a responsible health care professional for each item. During the case conference, individualised care plans will be made. This is then communicated with local services, primary and specialist teams resulting in streamlining of transfer of data and codifying responsibility for the patient, hospital and community care professionals.
16192839|NCT01450631|Device|Prevena™ Incision Management System (PIMS)|PIMS is a non-significant-risk, FDA Class II, medical device commercially available in the USA, Canada and Europe. The prospective, post-marketing clinical study described in this protocol will assess the effectiveness and functional performance of the system. The PIMS unit is a single patient use, battery-powered, disposable unit that can provide continuous -125 mmHg negative pressure over a 7-day therapy period. It is an easy to use device that also provides audible and visual alerts for low battery, maximum canister volume, and leak conditions. Additional alerts include system error and device life-cycle expiration (8 days). It is contained in a water-resistant housing, which allows the Subject to lightly shower with the device. Wound fluids are contained within the 45 mL canister.
16192883|NCT01450267|Drug|Inhaled Reduced Glutathione|10 mg/kg, twice daily, 12 months
16192884|NCT01450267|Drug|Physiological solution|0,13 ml/kg body weight, twice daily, 12 months
16196193|NCT01424982|Drug|Vincristine Sulfate|Given IV
16192840|NCT01450631|Device|Standard-of-care Dressing|The standard-of-care is consistent with the national standard for dressing Cesarean section incisions and includes, but not limited to, coverage of the sutured incision with sterile gauze and non-penetrable barrier (e.g., Tegaderm™). The non-penetrable barrier may be left in place for a minimum of 1 day and no longer than 2 days (± 4 hours) to promote epithelialization of the surgical incision edges. After the dressing is removed, the surgical site is left exposed to air to promote further healing. Other therapies include traditional gauze dressings with or without advanced therapies such as hydrocolloids, growth factors, and Negative Pressure Wound Therapy.
16192841|NCT01450605|Drug|No Intervention|Patients are previously on Reyataz® treatment or initiated Reyataz® for the first time
16192842|NCT01450592|Other|No drug|Diabetic Population
16192843|NCT01450592|Other|No drug|Non-Diabetic Population
16192844|NCT01450579|Biological|ASP7373|Intermuscular administration
16192845|NCT01450579|Biological|Placebo|Intramuscular administration
16192846|NCT01450566|Drug|Lidocaine|Use of lidocaine
16192847|NCT01450566|Drug|Saline|Saline
16192848|NCT01450540|Device|REMstar Auto A-Flex|Standard CPAP
16192849|NCT01450540|Device|modified REMstar Auto A-Flex with AGPAP|Modified device -Software upgrade to GP 12
16192850|NCT01450514|Drug|Pipamperone|15 mg PIP once daily per os on top of continued stable treatment with RIS or PAL
16192851|NCT01450514|Drug|Placebo|matching placebo sugar pill once daily per os on top of continued stable treatment with RIS or PAL
16192852|NCT01450488|Drug|masitinib|masitinib 3 mg/kg/day
16192853|NCT01450488|Drug|masitinib|masitinib 6 mg/kg/day
16192854|NCT01450475|Procedure|Remote ischemic postconditioning|At the time of reperfusion, remote ischaemic postconditioning will be induced by inflating a cuff around leg to 100 mmHg for 5 mins followed by 5 mins of reperfusion. This cycle will be repeated 3 times.
16192855|NCT01450462|Dietary Supplement|Vitamin D3 (cholecalciferol)|Women in the vitamin D arm take 50,000 international units (IU) of vitamin D3 (cholecalciferol) weekly for four weeks (end of week 1, week 2, week 3 and week 4), then every 4 weeks through 24 weeks of follow-up (end of week 8, week 12, week 16, week 20 and week 24) for a total of 9 treatments
16192856|NCT01450462|Dietary Supplement|Placebo|Women in the placebo arm will take their matching supplement weekly for four weeks (end of week 1, week 2, week 3 and week 4), then every 4 weeks through 24 weeks of follow-up (end of week 8, week 12, week 16, week 20 and week 24) for a total of 9 treatments
16192857|NCT01450449|Radiation|Radiotherapy|25 Gy in 5 daily fractions over 1 week
16192858|NCT01450449|Radiation|Radiotherapy|40 Gy in 15 daily fractions over 3 weeks
16192859|NCT01450436|Other|Peapod assessment|"EPIPOD consists in a Non-Interventional Research according to French regulations. Actually, Peapod examination at discharge takes part of current clinical practice and patient management in Nantes Neonatal Intensive Care Unit since 2008.
~After checking inclusion and non-inclusion criteria and obtaining oral informed consent from newborn legal authority or parents, PEAPOD assessment was leaded in the last week of hospitalization. Consisting in 2 repeated measurement, body composition estimation was completed by clinical and demographic data as neonatal nutrition (Parenteral nutrition pattern at Day 5, 10 and 21, and ASQ/BLR Neurodevelopmental assessment at 2 years old)."
16192860|NCT01450423|Behavioral|Physical activity|Participation in a 10-week supervised cardio exercise program two-three times a week. Each training session consists of 10 minutes of warm-up, 20 minutes treadmill run/walk and 30 minutes cycling. Heart rate (HR) is monitored during each session. Week 1-5: at least 15 minutes above 75% of HRmax in each session. Week 6-10: at least one session above 75% HRmax.
16192861|NCT01450410|Drug|Nicotinic acid|Nicotinic acid / laropiprant (Tredaptive 1000 mg/20 mg modified-release tablets). Patients treated with nicotinic acid 1g/day receive one dose of one month and 2 g / day thereafter. Nicotinic acid treatment will last for 12 weeks.
16192862|NCT01450410|Drug|Placebo|Placebo treatment will last for 12 weeks.
16192863|NCT01450397|Biological|XIAFLEX|One Injection of 0.58 mg of Xiaflex into the affected area of the hand.
16192864|NCT01450384|Drug|sorafenib tosylate|Given PO
16192865|NCT01450384|Drug|pemetrexed disodium|Given IV
16192866|NCT01450384|Other|laboratory biomarker analysis|Correlative studies
16192867|NCT01450384|Procedure|biopsy|Optional correlative studies
16192868|NCT01450371|Device|Interferential|The individuals are treated acutely with IES during 30 min, providing a continuous flow of symmetrical rectangular interferential current biphasic pulses using bipolar electrodes with two channels and a slope of 1/5/1. The fixed current is adjusted to 4000 Hz, with the current AMF at 100 Hz and an AMF variation of 25 Hz (25% of AMF).
16192869|NCT01450371|Device|Interferential Placebo|The same instructions and electrode positions were provided to the placebo, although the equipment did not provide any stimulation current
16192870|NCT01450358|Other|Antibiotic regimen|The medical researcher will change the antibiotic regimen (De-escalation) immediately as a result of Multiplex PCR (6-12 h).
16192871|NCT01450345|Drug|Pregabalin|The patient under Group P will be serving with 150 mg of oral Pregabalin 1 to 2 hours prior to induction.
16192872|NCT01450332|Device|Knee-T-Nol|The ACL prosthesis is intended for the treatment of ruptured ACL. It will be used as an implant to replace the native, torn ACL. Implantation will be done using arthroscopy
16192873|NCT01450319|Drug|Cetuximab|Cetuximab will be administered intravenously at a dose of 500 milligram per square meter (mg/m^2) every 2 weeks until disease progression, death, or consent withdrawal.
16192874|NCT01450306|Drug|D-cycloserine|50 mg d-cycloserine, oral, 1 dose
16192875|NCT01450306|Behavioral|Exposure therapy|Single session graded in vivo exposure therapy, 60-180 minutes
16192876|NCT01450306|Drug|Placebo|Single capsule of oral placebo, administered once 1 hr prior to exposure therapy
16192877|NCT01450293|Biological|AdCh63 ME-TRAP, MVA ME-TRAP|1x10^10 vp AdCH63 ME-TRAP followed by 1x10^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.
16192878|NCT01450293|Biological|AdCH63 ME-TRAP, MVA ME-TRAP|5x10^10 vp AdCH63 ME-TRAP followed by 1x10^8 pfu MVA ME-TRAP 8 weeks later. Intramuscular needle injection into the anterolateral thigh.
16192879|NCT01450280|Biological|ChAd63 CS|ChAd63 CS 5x10^9 vp intra-muscularly Day 0
16192880|NCT01450280|Biological|ChAd63 CS, MVA CS|ChAd63 CS 5x10^9 vp intra-muscularly Day 0; MVA CS 2x10^8 pfu intra-muscularly Day 56
16192881|NCT01450280|Biological|ChAd63 CS|ChAd63 CS 5x10^10 vp intra-muscularly Day 0
16192885|NCT01450254|Device|AposTherapy Biomechanical System|The system is a rehabilitation program implementing a device comprised of four adjustable modular elements attached to foot-worn platforms that are capable of manipulating the foot's center of pressure and applying perturbation training throughout the gait cycle. The device allows for neuromuscular training during dynamic loading.
16192886|NCT01450254|Other|Control|No intervention will be prescribed to the control group during participation in the study.
16192887|NCT01450241|Other|Early antibiotic discontinuation|Antibiotic treatment for unexplained febrile neutropenia stopped after 72 hours, regardless of fever
16192888|NCT01450241|Other|Usual practice|Continued antibiotic treatment as accepted by guidelines for febrile neutropenia
16192889|NCT01450228|Drug|KI1001|Prolonged release melatonin 2mg
16192890|NCT01450228|Drug|Placebo KI1001|Placebo KI1001 tablets
16192891|NCT01450215|Drug|Revlimid|Group R:25 mg lenalidomide 21 of 28 days will be given orally as maintenance .
16192892|NCT01450202|Other|bowel insufflation gas|air insufflation, during colonoscopy and esophagogastroduodenoscopy
16192893|NCT01450202|Other|bowel insufflation gas|CO2 insufflation, during colonoscopy and esophagogastroduodenoscopy
16192894|NCT01450189|Behavioral|Standard HIV prevention messages|A single session of standard HIV prevention messages during HIV post-test counseling with supplemental information regarding the acute stage of their infection.
16192895|NCT01450189|Behavioral|BI: Information-Motivation-Behavioral Skills Model|The behavioral intervention consists of five counselor-delivered sessions based on the Information-Motivation-Behavioral Skills (IMB) Model. The sessions are designed to provide participants with the information, motivation, and skills needed to abstain or practice protected sex during the brief acute HIV period, as well as plan for long-term behavioral risk reduction.
16192896|NCT01450189|Drug|Raltegravir|raltegravir (400 mg) administered orally twice daily for 12 weeks
16192897|NCT01450189|Drug|emtricitabine/tenofovir disoproxil fumarate|emtricitabine/tenofovir (200/300 mg daily) in a fixed dose combination administered orally for 12 weeks
16192898|NCT01450176|Drug|Olopatadine hydrochloride 0.2%|1 drop in each eye once daily for 2 weeks
16192899|NCT01450176|Drug|Bepotastine besilate ophthalmic solution 1.5%|1 drop in each eye twice daily for 2 weeks
16192900|NCT01450163|Drug|Pregabalin, Oxaliplatin|Oxaliplatin will be infused according to the FLOX treatment strategy, as a regular six-month-long adjuvant treatment to colorectal cancer. Pregabalin will be administered P.O. three days before and three days after each of the nine Ox infusions. The dose will be titrated during the first Ox infusion to the highest level tolerated by the patient. The dose used in this first session will be used in the eight following sessions.
16192901|NCT01450163|Drug|Placebo , Oxaliplatin|Oxaliplatin will be infused according to the FLOX treatment strategy, as a regular six-month-long adjuvant treatment to colorectal cancer. Placebo will be administered P.O. three days before and three days after each of the nine Ox infusions. The dose will be titrated during the first Ox infusion to the highest level tolerated by the patient. The dose used in this first session will be used in the eight following sessions.
16192902|NCT01450150|Device|Transcranial Direct Current Stimulation|20-minute daily sessions of 2 mA tDCS for 15 days (Monday to Friday on three consecutive weeks)
16192903|NCT01450150|Device|Transcranial Direct Current Stimulation|The tDCS stimulator will be turned on for 30 seconds only, after which it will be gradually decreased and then turned off for the remainder of the 20-minute daily sessions for 15 days (Monday to Friday on three consecutive weeks).
16192904|NCT01450137|Drug|Tocilizumab + Glucocorticoids (GCs)|Tocilizumab 8mg/kg every 4 weeks until week 52.
16192905|NCT01450137|Drug|Placebo + Glucocorticoids (GCs)|Placebo every 4 weeks until week 52.
16192906|NCT01450124|Drug|Boswellic acids (BOSWELAN)|8 months of treatment at a t.i.d. (Ter In Die (Latin: Three Times A Day) dose of between 400-1600 mg Boswelan
16192907|NCT01450111|Drug|Lacosamide|Lacosamide 50 mg, tablet, once in the morning on Day 1
16192908|NCT01450111|Drug|Lacosamide|Lacosamide 100 mg, tablet, once in the morning on Day 1 Lacosamide 100 mg, tablet, twice daily Day 5 to Day 8 and once in the morning on Day 9
16192909|NCT01450111|Drug|Lacosamide|Lacosamide 200 mg, tablet, once in the morning on Day 1 Lacosamide 200 mg, tablet, twice daily Day 5 to Day 8 and once in the morning on Day 9
16192910|NCT01450111|Other|Placebo|Placebo matched with Lacosamide 50 mg tablet once in the morning on day 1.
16192911|NCT01450111|Other|Placebo|Placebo matched with Lacosamide 100 mg, tablet, once in the morning on Day 1 Placebo matched with Lacosamode 100 mg, tablet, twice daily Day 5 to Day 8 and once in the morning on Day 9
16192912|NCT01450111|Other|Placebo|Placebo matched with Lacosamide 200 mg, tablet, once in the morning on Day 1 Placebo matched with Lacosamide 200 mg, tablet, twice daily Day 5 to Day 8 and once in the morning on Day 9
16192913|NCT01450098|Drug|LY2484595 Reference Formulation (RF)|Administered orally
16192914|NCT01450098|Drug|LY2484595 spray-dried solid dispersion-propyl gallate (SDSD-PG)|Administered orally
16192915|NCT01450085|Other|GeneXpert|Point of care GeneXpert
16192916|NCT01450085|Other|LED Microscopy|Point of care LED Microscopy
16192917|NCT01450072|Device|Selective Venography followed by therapeutic balloon angioplasty|Venography followed by therapeutic balloon angioplasty
16192918|NCT01450072|Other|Control arm|Venography and sham angioplasty
16192919|NCT01450046|Drug|Vitamin E δ-Tocotrienol|Vitamin E δ-Tocotrienol will be administered orally as a single agent twice daily for 14 consecutive days. Vitamin E δ-Tocotrienol is supplied as 100-mg, 200-mg, and 400-mg capsules. The first cohort will be dosed with δ-tocotrienol at 100 mg twice daily for 14 consecutive days. A minimum of 3 subjects is planned for each dosing cohort with Vitamin E δ-Tocotrienol dose escalation dependent on safety and available PK data from prior cohorts. At the MTD or MAD, 18 subjects will be enrolled.
16192920|NCT01450033|Behavioral|Peer Mentoring|Subjects will be assigned a peer mentor who will provide social support primarily via e-communication. They will also meet in-person at study entry, 6 months and 1-year.
16192921|NCT01450033|Behavioral|e-Communication with mentor|Subjects will interact on a mutually agreeable basis via their choice of text messaging, Facebook, phone calls, emails, and other formats
16192922|NCT01450020|Other|educational intervention|Receive ACS material
16192923|NCT01450020|Other|questionnaire administration|Ancillary studies
16192924|NCT01450020|Other|counseling intervention|Undergo PN session
16192929|NCT01450007|Drug|Dexamethasone|8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml (intravenous)
16192930|NCT01450007|Drug|Normal saline|5 ml normal saline (intravenous)
16192931|NCT01450007|Drug|Normal saline|0.8 ml normal saline (perineural)
16192932|NCT01449994|Device|Activator IV (Activator Methods Int. Phoenix, Arizona)|Instruments gives a defined impulse on specified areas of the body
16192933|NCT01449981|Behavioral|Integrated Twelve-Step Facilitation|The iTSF condition will include review of treatment goals and overall review of progress, coping skills, real life practices, emotions/mood management, how to make changes in one's social network and discussions about how 12-step meetings can be helpful in one's recovery efforts. In addition, speakers from 12-step fellowships such as Alcoholics Anonymous (AA) and Narcotics Anonymous (NA) will be invited to share their experiences and discuss myths and facts related to attendance at 12-step meetings as well as answer any questions participants have about these fellowships.
16192934|NCT01449981|Behavioral|Cognitive Behavioral Therapy|The CBT condition will include review of progress, coping skills, group exercises, real life practice, and emotions/mood management.
16192935|NCT01449968|Other|home visit|home visit of UMG
16192936|NCT01449968|Other|telephone management|telephone management of the situation reported by the patient's GP
16192937|NCT01449955|Drug|Rapamycin|"Sirolimus is an FDA approved immunosuppressant drug used to prevent rejection in organ transplantation, and is especially useful in kidney transplants. It is non-toxic to kidneys, unlike other immunosuppressants. In this study, the medication will be administered once to see if it interferes with emotional memory reconsolidation. This is based on the fact that it inhibits the mammalian target of Rapamycin (mTOR) through directly binding the mTOR Complex1 (mTORC1). mTOR is a serine/threonine protein kinase that regulates cell growth, cell proliferation, cell motility, cell survival, protein synthesis and transcription.
~a single dosage of 15mg will be administered during this study."
16192938|NCT01449955|Drug|Placebo|Inactive
16192939|NCT01449942|Biological|DNAzyme targeting EBV-LMP1 (DZ1)|"DZ1 in saline is administrated by intratumoral injection two hours prior to radiation therapy from week 1 to week 7 on Monday and Thursday. Dosage for each injection is 12 mg in 0.1 mL (200 micrograms per kilogram body weight.
~The radical radiotherapy is given to patients 5 times per week with 2 Gy of each treatment. The entire procedure lasts seven weeks."
16192940|NCT01449942|Other|Saline|"0.1 mL of saline is administrated by intratumoral injection two hours prior to radiation therapy from week 1 to week 7 on Monday and Thursday.
~The radical radiotherapy is given to patients 5 times per week with 2 Gy of each treatment. The entire procedure lasts seven weeks."
16192941|NCT01449929|Drug|dolutegravir 50 mg OAD|1 x 50 mg tablet OAD
16192942|NCT01449929|Drug|darunavir 800mg OAD|2 x 400mg tablets OAD
16192943|NCT01449929|Drug|ritonavir 100mg OAD|1 x 100mg tablet OAD
16192944|NCT01449916|Other|Simplified Severe Sepsis Protocol|Early fluid protocol, early blood cultures and antibiotics; blood cultures and titrated dopamine in selected patients; monitoring based on vital signs and physical examination
16192945|NCT01449890|Behavioral|E-mail follow up care|After having terminated inpatient CBT patients receive follow up care by email for 12 weeks (on average one contact per week). The follow up care aims at supporting the patients in continuing exercises in order to cope with depression.
16192946|NCT01449877|Drug|Trimethoprim-Sulfamethoxazole|Sulfamethoxazole 800mg + Trimethoprim 160mg / tablet. In treatment of acute phase, 1 tablet 12/12h 45 days. After acute phase, 1 tablet every other day, morning, 311 days. Placebo tablet - Composition: starch. After acute phase, 1 tablet every other day, morning, 311 days.
16192947|NCT01449864|Radiation|Proton therapy|The goal of radiation therapy is to deposit the majority of the radiation dose to the target while minimizing the dose to the surrounding normal tissues.
16192948|NCT01449838|Drug|Colistimethate sodium|active
16192949|NCT01449838|Drug|Saline|placebo
16192950|NCT01449825|Drug|Pazopanib use|Treatment with pazopanib
16192951|NCT01449825|Drug|Use of sunitinib, bevacizumab, or sorafenib|Treatment with any of the three other marketed anti-VEGF drugs: sunitinib, bevacizumab, and sorafenib
16192952|NCT01449812|Biological|Infanrix+Hib™|Intramuscular, one dose
16192953|NCT01449812|Biological|Poliorix™|Intramuscular, one dose
16192954|NCT01449799|Drug|GSK961081 800 microgram dose|To be provided via a combination of 4 inhalers - one 400 micrograms GSK961081 Diskus inhalation, a second 400 microgram GSK961081 Diskus inhalation and one inhalation each from two separate placebo Diskus inhalers
16192955|NCT01449799|Drug|Fluticasone Propionate 500 microgram dose|To be provided via a combination of 4 inhalers - one 250 microgram fluticasone propionate Diskus inhalation, a second 250 microgram fluticasone proopionate Diskus inhalation, and one inhalation each from two separate placebo Diskus inhalers
16192956|NCT01449799|Drug|GSK961081 800 microgram and Fluticasone Propionate 500 microgram separately|To be provided via a combination of 4 inhalers - one 400 microgram GSK961081 Diskus inhalation, a second 400 microgram GSK961081 Diskus inhalation, one 250 microgram fluticasone propionate Diskus inhalation, and a second fluticasone propionate 250 microgram Diskus inhalation
16192957|NCT01449799|Drug|GSK961081 800 microgram Fluticasone Propionate 500 microgram in a blend|To be provided via a combination of 4 inhalers - one inhalation of a Diskus inhaler containing a blend of 400 microgram of GSK961081 and 250 microgram of fluticasone propionate per inhalation, a second inhalation of a Diskus inhaler containing a blend of 400 microgram of GSK961081 and 250 microgram of fluticasone propionate per inhalation, and one inhalation each from two separate placebo inhalers
16192958|NCT01449786|Drug|rMal d 1|25 µg daily as sublingually administered drops, 16 weeks
16192959|NCT01449786|Drug|rBet v 1|25 µg daily administered sublingually as drops over 16 weeks
16192960|NCT01449786|Other|placebo drops|25 µg of placebo Drops daily administered sublingually over 16 weeks
16192961|NCT01449773|Dietary Supplement|n-3 PUFAs|5 capsules/day in order to provide 3 g/day of n-3 PUFAs.
16192962|NCT01449773|Dietary Supplement|Placebo|5 capsules/day containing corn and soybean oil
16192963|NCT01449760|Other|Physical Therapy|These patients have a standardized conventional therapy (i.e. 9 sessions of physical therapy over 6 weeks)
16192964|NCT01449760|Other|Wii Balance Board|These patients get an instruction about how to install and use the Wii Balance Board ®. After the instruction they get the equipment for 6 weeks.
16192965|NCT01449747|Drug|Sitagliptin|Sitagliptin (100mg, per oral) once a day.
16192966|NCT01449721|Drug|Intravenous fluid|0.9% Sodium chloride intravenous fluid
16192967|NCT01449708|Drug|TIVA NoNarc|"patients in both groups receive antiemetic prophylaxis
~patients in the TIVA NoNarc group will receive propofol, dexmedetomidine, ketamine, ketorolac and acetaminophen intraoperatively
~postop management in both groups is similar in both groups"
16192968|NCT01449695|Behavioral|Life style counseling|A nurse-based intervention with face-to-face contacts based on motivational interviewing techniques and influence on behavioral determinants. Well-trained nurses in our hospital will apply these behavioral change interventions. An individual contact will take about twenty minutes.
16192969|NCT01449695|Behavioral|an individualized web portal|This website shows patient's lab results, life style issues, blood pressure and weight in various risk monitors. These lab results and lifestyle changes will be visualized in risk monitors and provide structural feedback to the patient. The results of the screening and the two additional visits can be seen by the patient.
16192970|NCT01449695|Behavioral|individual and group consultations|group consultations with peers and a nurse individual consultation with a nurse
16192971|NCT01449682|Drug|Ozurdex|0.7 mg intravitreal DEX implant on first visit, then PRN if evidence of macular edema on OCT studies
16192972|NCT01449682|Drug|Ozurdex|0.7 mg intravitreal DEX implant on first visit then every 16 weeks
16192973|NCT01449656|Device|LMA Proseal: control device|LMA Proseal will be placed in children weighing 10-20kg based on a computer generated randomization
16192974|NCT01449656|Device|LMA Supreme: comparison device|LMA Supreme will be placed in children weighing 10-20kg based on a computer generated randomization
16192975|NCT01449643|Device|Threshold|
16192976|NCT01449643|Device|Sham Threshold|
16192977|NCT01449630|Drug|LY3031207|Administered orally
16192978|NCT01449630|Drug|Placebo|Administered orally
16192979|NCT01449630|Drug|Celecoxib|Administered orally
16192980|NCT01449617|Drug|Aspirin plus clopidogrel|"Clopidogrel, will be started 48 hours before the procedure with a loading dose of of 300mg and continued at 75mg/day.
~Aspirin will be given at the dose of 100-325mg/day."
16192981|NCT01449604|Radiation|stereotactic radiotherapy|Stereotactic radiotherapy, hypofraction using 18 Gray in 3 fractions
16192982|NCT01449604|Radiation|stereotactic radiosurgery|Radio surgery 12 Gy
16192983|NCT01449591|Drug|BFH772 1% ointment|
16192984|NCT01449591|Drug|Vehicle ointment|
16192985|NCT01449591|Drug|Noritate® 1% cream|
16192986|NCT01449578|Drug|Dexpramipexole|Oral Tablet at varying doses
16192987|NCT01449578|Drug|Dexpramipexole Placebo|Oral tablet at varying doses
16192988|NCT01449565|Drug|Naltrexone|3 monthly intramuscular injections of naltrexone 380 mg (extended release)
16192989|NCT01449565|Drug|Placebo|3 monthly intramuscular injections of placebo, matched to naltrexone 380 mg (extended release)
16192990|NCT01449552|Drug|Tranexamic acid|the drain was not clamped and the patient received tranexamic acid 10mg/kg intravenous 10 minutes before inflating the tourniquet and 10mg/kg intravenous three hours post-operative, and then tranexamic acid 250mg/capsule 2X3 orally for five days.
16192991|NCT01449552|Procedure|Drain clamping|the drain was clamped for three hours, released for three hours, then clamped for another three hours, and then released free for 48 hours. The patient received placebo (saline 10 minutes before surgery and three hours post-operative, and then an oral form of placebo 2X3 capsules for five days).
16192992|NCT01449552|Other|Drain clamping and tranexamic acid|the drain was clamped for three hours, released for three hours, then clamped for another three hours, and then released free for 48 hours. the patient received tranexamic acid 10mg/kg intravenous 10 minutes before inflating the tourniquet and 10mg/kg intravenous three hours post-operative, and then tranexamic acid 250mg/capsule 2X3 orally for five days.
16192993|NCT01449552|Other|No clamp and placebo|The drain was not clamped. The patient received placebo (saline 10 minutes before surgery and three hours post-operative, and then an oral form of placebo 2X3 capsules for five days).
16192994|NCT01449539|Drug|Hyperbaric Oxygen Therapy|Treatment Monday through Friday in a monoplace hyoerbaric chamber 100% oxygen at 2.0 atmospheres (14.7 PSI or the equivalent of being under 33 feet of sea water) for 90 minutes at pressure. Treatment lasts 2 hours as time is allowed for gradual pressurization and depressurization. Each subject will be treated for two weeks for a total of 10 HBOT treatments
16192995|NCT01449526|Device|B&L Investigational Contact Lens|Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.
16192996|NCT01449526|Device|B&L PureVision Contact Lens|Lenses will be worn on a daily wear basis for 3 months, new lenses dispensed monthly.
16192997|NCT01449513|Drug|Ingenol mebutate|0.05% Ingenol mebutate Gel once daily for 2 consecutive days
16192998|NCT01449513|Drug|Placebo Gel|Gel vehicle of PEP005
16192999|NCT01449500|Dietary Supplement|L. reuteri|Chewable tablet, one tablet/day for 28 days
16193000|NCT01449500|Dietary Supplement|Placebo|Chewable tablet, one tablet per day for 28 days
16193001|NCT01449487|Drug|PPC-5650|Solution for administration in the rectum Single dose of 25µg/ml at a volume of 50ml
16193002|NCT01449487|Drug|Placebo|Solution for administration in the rectum Identical tp active solution but without active drug
16193003|NCT01449474|Device|Patient matched instruments|The patients undergo TKA with using patient matched instruments
16193004|NCT01449474|Device|Jig based instruments|The patients undergo TKA with using jig based instruments
16193005|NCT01449461|Drug|Brigatinib|Brigatinib tablets and capsules.
16193006|NCT01449448|Drug|Ketorolac|Subacromial injection
16193007|NCT01449448|Drug|Triamcinolone|Subacromial Injection
16193008|NCT01449435|Other|Methacholine challenge testing|Nebulized methacholine administered at the following doses: 0,1 mg/0,4 mg/0,8 mg/1,6 mg
16193009|NCT01449422|Device|Dressing|the dressing should be changed on average every 1 to 2 days, then as often as required (up to 7 days) depending on the exudate volume and the clinical condition of the wound (evaluated by the investigating doctor).
16193010|NCT01449422|Device|Dressing|the hydrofibre dressing should be changed when it is saturated, or depending on the clinical appreciation of the situation. The dressing can remain in place for up to 7 days.
16193094|NCT01448811|Procedure|Ramsay Sedation Scale|During bronchoscopy, nurses adjusted propofol dose according to Ramsay Sedation Scale.
16193097|NCT01448785|Device|abiliti system implant|Subjects will receive implanted abiliti System.
16193011|NCT01449409|Other|Real-time asthma care outreach|Real-time asthma care identification of uncontrolled asthma and real-time notification of patients and their physicians of uncontrolled asthma and directions to improve care. Patients without an asthma specialist visit in the prior 3 years are offered an expedited allergy department referral.
16193012|NCT01449396|Other|Bed Rest|Bed rest during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer
16193013|NCT01449396|Procedure|Acupuncture|Sham acupuncture during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer
16193014|NCT01449396|Procedure|Acupuncture|Acupuncture during 25 minutes on day 1, 4 and 6 of ovarian stimulation, before and after embryo transfer
16193015|NCT01449383|Dietary Supplement|low meat high fibre|less than 30g red meat and at least 40g dietary fibre per day
16193016|NCT01449383|Dietary Supplement|high meat low fibre|at least 200g red meat (pork, beef or other mammals) and not more than 20g dietary fibre per day
16193017|NCT01449370|Drug|TAK-117|oral administration of TAK-117, daily and intermittent schedules.
16193018|NCT01449357|Drug|zalutumumab|IV infusion, 16mg/kg on weekly basis until DP
16193019|NCT01449344|Drug|Rituximab|Rituximab 375mg/m² IV , day 1
16193020|NCT01449344|Drug|High dose Ara-C|Ara-C 2000 mg/m² (patients >65 years or s/p myeloablative treatment: 1000 mg/m²) IV, d 2 and 3
16193021|NCT01449344|Drug|Dexamethasone|Dexamethasone 40 mg PO, day 1-4
16193022|NCT01449344|Drug|Bortezomib|Bortezomib 1.5 mg/m² IV, day 1 and 4
16193023|NCT01449318|Device|Thermal Sensory Analyzer (Senselab)|"Thermal stimuli will be administered to the ventral surface of the dominant forearm and then to the lower abdomen (surgical site)using the Thermal Sensory Analyser. Each thermal testing trial will be separated by approximately 2 min and at a separate site.
~To measure the thermal pain threshold temperature, The thermode will be applied to the ventral surface of the dominant forearm and the temperature will be increased at 1°C/s from 35 to 50°C.
~To measure the Suprathreshold Thermal Pain Intensity and unpleasantness, Stimulus responses for noxious heat stimuli will be performed by applying phasic heat stimuli at 8 different temperatures (35, 43, 44, 45, 46, 47, 48, and 49°C)."
16193024|NCT01449305|Device|Nanoone Woman Underwear|Chen Yi Enterprise, Co., Ltd. design a kind of negative ion materials can supply delocalized electron, and add fiber inside, make clothes to wear in the body, no external power or battery, only depend on infrared body photon hit of thermoelectric effect or heart compression pulse, blood flow of piezoelectric, therefore can sustained sufficient amount of effective negative ion, to eliminate positive ions in vivo, or make oxygen free radical to obtain the lack electrons. Decrease active free radical and get non toxic effect in short time.
16193025|NCT01449292|Device|Treatment plus Optimal Medical Therapy|Patients will be treated with the AeriSeal System in 2 subsegments in the upper lobes of each lung (4 subsegments total). 20mL of foam sealant will be injected via catheter into each subsegment selected for treatment. Patients will also receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema have been published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary).
16193026|NCT01449292|Other|Optimal Medical Therapy|Patients will receive Optimal Medical Therapy. Guidelines for prescribing medical treatment for emphysema have been published by the American Thoracic Society (ATS) and the National Heart Lung and Blood Institute/World Health Organization (NHLBI/WHO GOLD workshop summary).
16193027|NCT01449279|Drug|Ipilimumab|Ipilimumab will be administered as a single agent standard of care with base dose of 3 mg/kg iv over approximately 90 minutes every 3 weeks for a total of 4 treatments.
16193028|NCT01449279|Radiation|Radiation Therapy|Standard of care palliative radiation therapy will start within 5 days of the first ipilimumab dose. Dose is dependent upon lesion size and is determined by the radiation oncologist.
16193029|NCT01449266|Drug|Dotarem® IV injection at 0.1 mmol/kg|Dotarem® was IV administered at a dose of 0.1 mmoL/kg (0.2 mL/kg).
16193030|NCT01449253|Drug|Sildenafil|20 mg initially and then increased to 20 mg TDS if there is no fall in BP
16193031|NCT01449253|Drug|Bosentan|Bosentan 62.5 mg BD initially for 1 month and then increased to 125 mg BD
16193032|NCT01449240|Other|No treatment|
16193033|NCT01449214|Procedure|Ultrasound|Ultrasound-guided technique
16193034|NCT01449214|Procedure|Landmarking|Landmark-guided technique
16193035|NCT01449201|Drug|PF-00299804|45 mg P.O. Daily (28-day treatment as one treatment cycle)
16193036|NCT01449188|Drug|ondansetron|FDA approved drug used to treat nausea and vomiting
16193037|NCT01449188|Drug|moxifloxacin|FDA approved antibiotic commonly used as a positive control in thorough QT studies
16193038|NCT01449188|Other|saline|USP saline IV solution used as placebo for ondansetron IV.
16193039|NCT01449162|Drug|Masitinib|6 mg/kg/day
16193040|NCT01449162|Drug|Placebo|
16193041|NCT01449149|Radiation|Proton Therapy|
16193042|NCT01449136|Other|Antibacterial cement|Glass ionomer cement containing 1% each of metronidazole, ciprofloxacin, and cefaclor
16193043|NCT01449123|Drug|Mannitol challenge test & reversibility test|"Patients perform an asthma control test (ACT) to establish if they are well controlled or symptomatic. All patients will perform then perform the mannitol challenge test. Aridol™ is an indirect osmotic bronchial challenge test which can be used to identify bronchial hyperresponsiveness"
16193044|NCT01449110|Dietary Supplement|Placebo in primary cardiovascular prevention (PP)|"12 months follow-up:
~capsule/day of placebo (350 mg maltodextrin) for 6 months
~capsules/day of placebo (350 mg + 350 mg maltodextrin) for 6 months"
16193045|NCT01449110|Dietary Supplement|Placebo in secondary prevention|"12 months follow-up:
~capsule/day (350 mg maltodextrin) for 6 months
~capsules/day (350 mg + 350 mg maltodextrin) for 6 months"
16193046|NCT01449110|Dietary Supplement|Grape extract in primary prevention (PP)|"12 months follow-up:
~capsule/day (350 mg grape extract) for 6 months
~capsules/day (350 mg + 350 mg grape extract) for 6 months"
16193047|NCT01449110|Dietary Supplement|Grape extract in SP|"12 months follow-up:
~capsule/day (350 mg grape extract) for 6 months
~capsules/day (350 mg + 350 mg grape extract) for 6 months"
16193095|NCT01448798|Procedure|Application of a hemostatic gelatin-thrombin matrix|Hemostatic gelatin-thrombin matrix is used for hemostasis during nerve-sparing dissection of the prostate.
16193096|NCT01448798|Procedure|Use of mono- and bipolar electrocautery and surgical clips|Mono- and bipolar electrocautery and surgical clips are used for hemostasis during nerve-sparing dissection of the prostate.
16193048|NCT01449110|Dietary Supplement|Resveratrol-enriched grape extract in PP|"Resveratrol-enriched grape extract (Stilvid) is obtained from grapes treated with UVC illumination. Similar polyphenolic content to conventional grape extract used in the arms 'Grape extract in PP' and 'Grape extract in SP' but containing 8 mg resveratrol.
~12 months follow-up:
~capsule/day (350 mg resveratrol-enriched grape extract) for 6 months
~capsules/day (350 mg + 350 mg resveratrol-enriched grape extract) for 6 months"
16193049|NCT01449110|Dietary Supplement|Resveratrol-enriched grape extract in SP|"Resveratrol-enriched grape extract (Stilvid) is obtained from grapes treated with UVC illumination. Similar polyphenolic content to conventional grape extract used in the arms 'Grape extract in PP' and 'Grape extract in SP' but containing 8 mg resveratrol.
~12 months follow-up:
~capsule/day (350 mg resveratrol-enriched grape extract) for 6 months
~capsules/day (350 mg + 350 mg resveratrol-enriched grape extract) for 6 months"
16193050|NCT01449097|Procedure|Adductor-Canal-Blockade|US-guided Adductor-Canal-blockade with Ropivacaine
16193051|NCT01449097|Procedure|The femoral nerve block|US-guided femoral nerve block with ropivacaine
16193052|NCT01449097|Procedure|Placebo|US-guided Adductor-Canal-Blockade/femoral nerve block with saline
16193053|NCT01449084|Procedure|immediate stent removal|"The stent used was a 5-Fr polyethylene duodenal pigtail pancreatic stent without an inner flange. The stent length was 4 or 5 cm (Zimmon stent, Cook Endoscopy, Winston-Salem, NC, USA): selection was based on the degree of flexion and the length of the Wirsung duct in the head of the pancreas.
~THE STENT WAS REMOVED AT THE END OF THE ERCP PROCEDURE"
16193054|NCT01449084|Other|Leaving the stent in place|"The stent used was a 5-Fr polyethylene duodenal pigtail pancreatic stent without an inner flange. The stent length was 4 or 5 cm (Zimmon stent, Cook Endoscopy, Winston-Salem, NC, USA): selection was based on the degree of flexion and the length of the Wirsung duct in the head of the pancreas.
~THE STENT WAS LEFT IN PLACE AT THE END OF THE ERCP PROCEDURE"
16193055|NCT01449071|Biological|Placebo|Placebo infusions at study weeks 0, 1, 2, and 3.
16193056|NCT01449071|Biological|Epratuzumab 400 mg|Epratuzumab 400 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.
16193057|NCT01449071|Biological|Epratuzumab 1200 mg|Epratuzumab 1200 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.
16193058|NCT01449071|Biological|Epratuzumab 100 mg|Epratuzumab 100 mg infusions at study weeks 0, and 2, and placebo infusion at study weeks 1 and 3.
16193059|NCT01449071|Biological|Epratuzumab 600 mg|Epratuzumab 600 mg infusions at study weeks 0, 1, 2, and 3.
16193060|NCT01449058|Drug|BYL719|taken orally
16193061|NCT01449058|Drug|MEK162|taken orally
16193062|NCT01449045|Drug|IPTc+CCM|Monthly administration of sulfadoxine-pyrimethamine plus amodiaquine, combined with community case management
16193063|NCT01449045|Drug|Community Case Management with artemether-lumefantrine (AL)|Malaria diagnosis with Rapid Diagnostic Test and treatment with AL if the test is positive
16193064|NCT01449032|Biological|MSC|No of cells after culture expansion
16193065|NCT01449032|Biological|Saline|3 cc saline
16193066|NCT01449019|Drug|exendin(9-39)amide|intravenous infusion of exendin(9-39)
16193067|NCT01449019|Drug|saline|intravenous infusion of saline
16193068|NCT01449019|Other|duodenal meal|duodenal perfusion of a meal
16193069|NCT01449019|Other|duodenal saline|duodenal perfusion of saline
16193070|NCT01449006|Drug|Maraviroc|Maraviroc oral tablet. Dosage: 150 mg twice daily, 300 mg twice daily, or 600 mg twice daily. Dosing will be dependent on the participant's background HAART therapy, and will be in accordance with the product information sheet.
16193071|NCT01448993|Drug|Azithromycin|Taking 250mg azithromycin 3 times per week in alternate days.
16193072|NCT01448993|Drug|Placebo|
16193073|NCT01448980|Procedure|Thai Traditional Massage (TTM)|Thai Traditional Massage will receive massage 2 time per week for 6 weeks
16193074|NCT01448980|Procedure|Physical therapy program|Physical therapy program 2 times per week for 6 weeks.
16193075|NCT01448954|Drug|ADC3680B oral|Once daily for 28 days
16193076|NCT01448954|Drug|Placebo oral|Once daily for 28 days
16193077|NCT01448941|Procedure|Temporary extraarticular plate fixation|Arm 1: Primary arthrodesis TMT 1 Arm 2: Temporary extraarticular plate fixation TMT 1
16193078|NCT01448941|Procedure|Primary arthrodesis|Primary arthrodesis
16193079|NCT01448941|Procedure|Primary arthrodesis TMT 2 and 3|Primary arthrodesis TMT 2 and 3 when instability is present
16193080|NCT01448928|Drug|[90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)|Patients who have received Zevalin for relapsed or refractory, CD20+, low grade B-cell non-Hodgkin's lymphoma and Mantle cell lymphoma.
16193081|NCT01448902|Drug|OC000459|OC000459 200mg bid for 8 days
16193082|NCT01448902|Drug|Placebo|Placebo bid for 8 days
16193083|NCT01448889|Drug|100% oxigen|patients will recive 100% oxigen in a mask with reservoir from the begginind of the procedure to 4 hours after its termination
16193084|NCT01448889|Drug|placebo|patients will recive 21% oxigen (room air) in a mask with reservoir from the begginind of the procedure to 4 hours after its termination
16193085|NCT01448863|Other|Culture medium metabolomic analysis|"During the embryo transfer at day 3, the investigators keep and freeze a small drop of the culture medium of each embryo transferred. Each drop of culture medium will have a volume of 40-50 microliters, before freezing is spun at 10.000 rps to avoid any possible contamination.
~The frozen media culture is analyzed for the metabolomic profile."
16193086|NCT01448850|Biological|MEDI8968 600 mg IV, 300 mg SC|MEDI8968 600 mg as IV infusion on Day 1 followed by 300 mg injection SC every 4 weeks up to Week 53.
16193087|NCT01448850|Other|Placebo|Placebo matched to MEDI8968 as IV infusion on Day 1 followed by SC injection every 4 weeks up to Week 53.
16193088|NCT01448837|Drug|Bimatoprost/Timolol, 24-hour intraocular pressure monitoring|Administered once in the evening
16193089|NCT01448837|Drug|Latanoprost, 24-hour intraocular pressure monitoring|assessment of 24-hour efficacy for the two drugs after 3 months of chronic dosing
16193090|NCT01448824|Drug|LY2484595|Administered orally
16193091|NCT01448824|Drug|Placebo|Administered orally
16193092|NCT01448824|Drug|Ketoconazole|Administered orally
16193093|NCT01448811|Device|AEP monitor|In AEP monitoring group, nurses adjusted propofol dose according to AAI values. If AAI>40, titrate up propofol dosage, AAI<25, titrated down propofol dosage.
16196271|NCT01424384|Drug|Citalopram|Neurophysiological testing.
16193098|NCT01448785|Device|Laparoscopic adjustable gastric band (Allergan Lap Band)|Subjects will receive an implanted laparoscopic adjustable gastric band. Specific brand is at the investigator's discretion.
16193099|NCT01448772|Drug|Dronabinol Capsules, 5 mg|Comparison of different routes of administration of a drug using the approved Abbott 5 mg capsule product under fasting conditions; two treatment periods with a washout period separating the study periods
16193100|NCT01448772|Drug|Dronabinol Oral Solution|Comparison of different routes of administration of a drug using a proposed oral solution formulation under fasting conditions; two treatment periods with a washout period separating the study periods
16193101|NCT01448759|Other|blood sampling|Other: Blood sampling 10mL of peripherical blood will be collected specially for the study. It's an additional blood sampling compare to the normal follow up of the patient.
16193102|NCT01448746|Drug|low molecular weight heparin|40mg 12 hours before surgery and 12 hours later surgery
16193103|NCT01448733|Drug|Benzoyl peroxide 2.5%/clindamycin phosphate 1.2% in the morning with with tretinoin 0.05% gel in the evening|Green pea sized amount of Benzoyl peroxide 2.5%/clindamycin phosphate 1.2% in the morning in combination with a green pea sized amount of tretinoin 0.05% gel in the evening
16193104|NCT01448720|Drug|Paliperidone palmitate|Type=exact number, unit=mg, number=150, 100, 75 mg equivalent (eq), form=suspension for injection, route=intramuscular use. One IM injection of 150 mq on Day 1, 100 mg eq. on Day 8 (+/- 4 days), and 75 mg eq. is recommended on Days 36, 64, and 92.
16193105|NCT01448707|Drug|Darunavir|Darunavir (DRV): type = exact number, unit = mg, number = 800, form = tablet, route = oral use
16193106|NCT01448707|Drug|Ritonavir|ritonavir (rtv): type = exact number, unit = mg, number = 100, form = tablet, route = oral use
16193107|NCT01448694|Other|No treatment|No treatment, only collecting observational data.
16193108|NCT01448681|Other|No Interventions|
16193109|NCT01448642|Drug|Atorvastatin|Atorvastatin loading dose of 80mg before PCI, reloading dose of 80mg 24 hours after PCI, and atorvastatin 40mg for 30 days
16193110|NCT01448642|Drug|Placebo|Matching placebo before PCI and 24 hours after PCI. Atorvastatin 40mg for 30 days
16193111|NCT01448629|Device|Standard Care|"Participants are using their own product and this procedure is called Standard Care.
~Standard Care are the participants own products and may consist of several manufacturer and brand names."
16193112|NCT01448629|Device|River|River is a new developed product with Coloplast as manufacturer
16193113|NCT01448616|Drug|TDF|Oral tenofovir will be administered as tablets. TDF (Viread®) tablets contain 300 mg of tenofovir disoproxil fumarate, which is equivalent to 245 mg of tenofovir disoproxil. Study participants are instructed to take the one tablet, by mouth, once each day without regard to meals.
16193114|NCT01448616|Drug|Placebo Vaginal Gel|"Study participants are instructed to insert one dose (the entire contents of one applicator) of product into the vagina once each day. They are instructed to insert their gel as close to the same time each day as possible.
~The placebo gel (known as the 'universal' placebo gel) is formulated to minimize any possible effects - negative or positive - on study endpoints."
16193115|NCT01448616|Drug|Vaginal TFV Gel|Tenofovir 1% gel (w/w) is a gel formulation of tenofovir. Study participants are instructed to insert one dose (the entire contents of one applicator) of product into the vagina once each day. They are instructed to insert their gel as close to the same time each day as possible.
16193116|NCT01448616|Drug|Placebo Tablets|TDF placebo tablets are film-coated and contain denatonium benzoate, a bittering agent, in addition to other inactive ingredients. Study participants are instructed to take the one tablet, by mouth, once each day without regard to meals.
16193117|NCT01448603|Biological|Placebo|No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.
16193118|NCT01448603|Biological|ToleroMune Ragweed|No further medication to be administered in this study. Intervention refers to treatment received in Study TR002.
16193119|NCT01448564|Other|Laser therapy|The therapeutic effects of low intensity lasers are: (i) analgesic and anti-inflammatory, (ii) regeneration, (iii) tissue healing and (vi) recovery from muscle fatigue.
16193120|NCT01448564|Other|Placebo laser therapy|The application of laser therapy will be a low intensity laser.
16193121|NCT01448551|Behavioral|Tailored Mobile Messages to Enhance Weight Loss for Teens|For this trial adolescents will be allowed to use their own phone (with reimbursement for any study-related costs), or will be provided with a mobile phone, if requested. Participants will receive messages delivered daily over the course of 20 weeks. The content of the messages will be tailored on participants' responses to the MPOWER enrollment survey and the initial tailoring questionnaire. On school days, all messages will be sent after 3 pm (which is after school hours for most Michigan middle and high schools). Therefore, patients will not need to carry cell phones to school. The tailored messages will utilize various degrees of personalization, adaptation and feedback - including momentary assessments with feedback requiring a text reply from the adolescents.
16193122|NCT01448538|Drug|Anti-VEGF injections|All Anti-VEGF injections approved for the German market, dosages as defined by doctors
16193123|NCT01448525|Drug|bimatoprost ophthalmic solution 0.03%|One drop of bimatoprost ophthalmic solution 0.03% applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
16193124|NCT01448525|Drug|bimatoprost vehicle solution|One drop of bimatoprost vehicle solution applied to the upper eyelid margin of both eyes once daily in the evenings for 16 weeks.
16193125|NCT01448512|Behavioral|PartnerPlus Intervention|The intervention employs a closed, structured, group intervention limited to 10 participants (women or men). Four weekly, 11/2-2 hour sessions are led by a trained gender-congruent counselor and a peer facilitator and emphasize group participation, cognitive-behavioral skill building, sexual negotiation and experimentation with products.
16193126|NCT01448512|Other|Usual Care|4 time matched sessions focused on health education
16193127|NCT01448499|Drug|Clozapine|escalating dose of clozapine up to 900 mg/day
16193128|NCT01448499|Drug|Amisulpride|escalating dose of amisulpride up to 800 mg/day
16193129|NCT01448499|Drug|Clozapine+Amisulpride|augmentation of clozapine with amisulpride
16193130|NCT01448486|Drug|Raltegravir|Oral raltegravir, 400 mg tablet, twice daily for one year.
16193131|NCT01448473|Other|4-views series|The 4-film series will include the following views: anterior-posterior; one lateral; Waters, and Townes views.
16193132|NCT01448473|Other|2-views serie|The 2-film series will include the following views: anterior-posterior and one lateral.
16193133|NCT01448447|Device|Mammosite ML|34 Gy / 10 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 5 consecutive working days
16193134|NCT01448447|Device|Mammosite ML|5-10.2 Gy / 2-3 fractions (3.4 Gy per fraction) 2 fractions / day (separated by at least 6 hours) Delivered in 1-2 days Followed by whole breast radiation (25-28 daily tx)
16193135|NCT01448434|Biological|Ex- vivo cultured adult allogeneic MSCs|Single intraarticular dose of allogeneic MSCs suspended in 2ml Plasmalyte followed by 2ml of Hyaluronan
16193136|NCT01448434|Biological|Plasmalyte-A|Single intraarticular dose of 2ml Plasmalyte followed by 2ml Hyaluronan
16193137|NCT01448421|Device|Keystone Heart Embolic Deflection Device|The Keystone Heart Embolic Deflection Device is used in the aortic arch to deflect and to reduce embolic material (debris/thrombus) to the cerebral/carotid arteries during endovascular procedures.
16193138|NCT01448395|Drug|[14C]NXL104|500mg/100mL intravenous solution
16193139|NCT01448382|Device|PillCam® capsule with Given PillCam® Platform|capsule endoscopy
16193140|NCT01448369|Device|Blephasteam|10 minute treatment twice daily
16193141|NCT01448369|Device|EyeGiene|10 minute treatment, twice daily
16193142|NCT01448369|Device|Hot compresses|10 minute treatment, twice daily
16193143|NCT01448356|Procedure|temperature and humidity|"The volunteer is exposed to a controlled environment with a chamber setting of:
~25°C and 45% humidity;
~25°C and 65% humidity;
~30°C and 45% humidity;
~30°C and 65% humidity
~After an adaptation period of at least 20 minutes, participants underwent measurements of tear evaporation and tear film break up time. After collection of data, the chamber settings were adjusted to the next condition."
16193144|NCT01448343|Device|Fluid management system 2000 (FMS)|The FMS has an integrated large volume (about 3000 ml) reservoir and delivers a blood mixture (4 unit RBC, 4 unit FFP and 800 ml normal saline) put in the reservoir at a maximum rate of 750 ml/min.
16193145|NCT01448330|Drug|HCP0911 / clopidogrel, aspirin|combination tablet vs coadministration
16193146|NCT01448317|Drug|Alirocumab (Solution)|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
16193147|NCT01448317|Drug|Alirocumab (Lyophilized formulation)|"Pharmaceutical form: lyophilized formulation
~Route of administration: subcutaneous"
16193148|NCT01448317|Drug|Placebo (Solution)|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
16193149|NCT01448317|Drug|Placebo (Lyophilized formulation)|"Pharmaceutical form: lyophilized formulation
~Route of administration: Subcutaneous"
16193150|NCT01448304|Drug|alirocumab SAR236553 (REGN727)|Pharmaceutical form:Solution Route of administration: Subcutaneous
16193151|NCT01448291|Drug|Etonogestrel /Ethinyl Estradiol Contraceptive Vaginal Ring|Etonogestrel 0.12mg/Ethinyl Estradiol 0.015mg Vaginal Ring (NuvaRing®) for 3 months
16193152|NCT01448278|Procedure|"All-inside"|"The All-inside technique is a new minimally invasive procedure for anterior cruciate ligament reconstruction (ACL). It consists of incomplete bone tunnels drilling and cortical fixation."
16193153|NCT01448278|Procedure|Classical technique|The Classical technique is a usual procedure for anterior cruciate ligament reconstruction (ACL). The fixation is achieved with interference screws.
16193154|NCT01448265|Procedure|Cryoballoon ablation.|Cryoballoon ablation using a novel circular mapping catheter.
16193155|NCT01448252|Biological|multiple (4 autologous subcutaneous T cell vaccinations with T cell lines reactive to nine myelin peptides)|multiple (4 autologous subcutaneous T cell vaccinations with T cell lines reactive to nine myelin peptides at days 1, 30,90,180
16193156|NCT01448252|Biological|T cell vaccination|Multiple injections of autologous T cell lines reactive to 9 myelin peptides.
16193157|NCT01448239|Drug|alirocumab SAR236553 (REGN727)|Pharmaceutical form:Solution Route of administration: Subcutaneous
16193158|NCT01448239|Drug|alirocumab SAR236553 (REGN727)|Pharmaceutical form:Solution Route of administration: Subcutaneous
16193159|NCT01448213|Drug|Prednisolone acetate|Subjects assigned to Treatment Regimen A will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for 3 months, then 3 times a day for one month, then twice a day for one month, then once a day until the subject exits the study.
16193160|NCT01448213|Drug|Fluorometholone|Subjects assigned to Treatment Regimen B will instill 1 drop of prednisolone acetate 1% four times a day in the transplant eye for one month. Then they will instill one drop of fluorometholone four times a day in the transplant eye for 2 months, then 3 times a day for 1 month, then twice a day for 1 month, then once a day until the subject exits the study.
16193161|NCT01448200|Drug|PPI-668|capsules
16193162|NCT01448200|Drug|Placebo|capsules
16193163|NCT01448174|Drug|Atorvastatin|"Atorvastatin (10 - 80 mg/day) will be administered orally in the one evening dose in the case of strict indications for such a treatment. Before starting atorvastatin, serum lipid profile will be examined two times, and when both results are abnormal the treatment is started. Duration of administration:
~atorvastatin 12 weeks, 6 weeks washout, placebo 12 weeks or
~placebo 12 weeks,6 weeks washout,atorvastatin 12 weeks."
16193164|NCT01448148|Other|Cognitive intervention|Different strategies will be included to improve episodic memory. Training on imagery will be provided prior to episodic training.Particular attention will be paid to memory self-efficacy and the negative perception that elderly individuals entertain about memory tasks. The issue of generalization is of major importance in cognitive therapy.
16193165|NCT01448148|Other|Psychosocial intervention|Based on a cognitive-behavioural approach, the psychosocial intervention will aim at improving general psychological well-being or preventing psychological distress in persons with MCI.
16193166|NCT01448135|Other|VITAL AF|Semi-elemental, high protein, and high omega-3 fish oil enteral formula
16193167|NCT01448135|Other|Osmolite 1.2|High protein enteral formula
16193168|NCT01448122|Other|Avene Compact Honey SPF 50|Patients will have part of their back covered with 2 mg/mL of Avene Compact Honey SPF 50.
16193169|NCT01448109|Drug|Hydrocortisone|Hydrocortisone 100mg vial (blinded) is reconstituted with 2ml of water for Injection, agitated for 20 seconds, rested for 3 minutes, contents of vial aspirated and added to 100ml bag of normal saline or 5% dextrose and given intravenously as a continuous infusion at rate of 200mg/per day for 7 days.
16193170|NCT01448109|Drug|Sterile air filled vial|"the sterile air filled vial (blinded) is reconstituted with 2ml of water for Injection, agitated for 20 seconds, rested for 3 minutes, contents of vial aspirated and added to 100ml bag of normal saline or 5% dextrose and given intravenously as a continuous infusion. 2 sterile air filled vials per day for 7 days"
16193171|NCT01448096|Drug|Rituximab|R-CHOP21 consist of rituximab (375 mg/m2), cyclophosphamide (750 mg/m2), doxorubicin (50 mg/m2), and vincristine (1.4 mg/m2, a maximum of 2mg), administered intravenously on day 1 and 100 mg oral prednisone on days 1 through 5.
16193172|NCT01448096|Procedure|Prophylactic intrathecal chemotherapy|Prophylactic intrathecal chemotherapy using methotrexate (12mg total dose) will be performed
16193173|NCT01448083|Other|Standard of care diagnostic MIBG scan for neuroendocrine tumor diagnosis.|Each subject will receive a 370 MBq (10 mCi ) (±10%) injection of I- 123 MIBG. Myocardial I-123 MIBG uptake will be quantitatively measured over time via planar imaging acquired at 15 minutes, one, two, four, and at 24 hours (the standard of care time point for NET patient imaging) post I-123MIBG injection.
16193174|NCT01448070|Drug|human insulin|Single dose of 0.2 IU/kg, administered subcutaneously (under the skin)
16193175|NCT01448057|Drug|Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets|Paracetamol (500 mg)/dimethindene maleate (1 mg)/ phenylephrine hydrochloride (10 mg) tablets
16193176|NCT01448057|Drug|Paracetamol (500 mg) tablets|Paracetamol (500 mg) tablets
16193177|NCT01448044|Drug|BMS-790052 (NS5A Replication Complex Inhibitor)|
16193178|NCT01448044|Drug|Placebo matching BMS-790052|
16193179|NCT01448044|Drug|Pegylated-interferon alfa 2a|
16193180|NCT01448044|Drug|Ribavirin|
16193181|NCT01448031|Drug|Capsule ASA 81mg/esomeprazole 20mg|Multiple doses administered on Day 1 to 5
16193182|NCT01448031|Drug|Acetylsalicylzuur Apotex Cardio|Multiple doses administered on Day 1 to 5
16193183|NCT01448018|Drug|ranibizumab|3 monthly intravitreous injection as soon as possible after the inclusion
16193184|NCT01448018|Procedure|hemodilution|hemodilution using erythrocytapheresis - target hematocrit: 35% - as soon as possible after the inclusion
16193185|NCT01448005|Device|wearable defibrillator (LifeVest)|A wearable defibrillator automatically detects and treats ventricular tachycardia and ventricular fibrillation without the need for bystander intervention.
16193186|NCT01447992|Device|Portable artificial pancreas system with Control-To-Range|We will test the new portable Control-To-Range system in clinical research center conditions for 10 hours followed by 18 hours of Control-To-Range in a hotel.
16193187|NCT01447979|Device|portable artificial pancreas system with Control-To-Range algorithms|The investigators will test the new portable CTR system in CRC conditions for 10h followed by 18h of CTR in a hotel.
16193188|NCT01447966|Behavioral|Cognitive Behavioral Therapy|Family based cognitive behavioral therapy with exposure and response prevention. Twice weekly for 45-60 minute visits.
16193189|NCT01447953|Other|Activity targeted pain rehabilitation|An activity and life-role targeting rehabilitation programme (ALAR) provided by one of the care givers in the multi-professional rehabilitation teams at each of the eight participating primary health care centres, by ten weekly 1-hour treatment sessions.
16193190|NCT01447953|Other|Treatment as usual|Usual treatment with type of treatment modalities, number, frequency and duration of visits according to the judgement of the muli-professional teams at each primary health care centre.
16193191|NCT01447940|Device|Meos ePortal use|Patients will use Meos ePortal + 2 standard visits (inclusion and 12 months) + additional visits if necessary + HbA1c measure at 6 months
16193192|NCT01447927|Drug|metformin hydrochloride|Given PO QD and BID
16193193|NCT01447927|Other|placebo|Given PO QD and BID
16193194|NCT01447914|Drug|Tivantinib|Given at a dose of 360 mg oral (PO) twice daily continuously for each day of every 4-week treatment cycle, which will be taken as three tablets of 120 mg each.
16193195|NCT01447914|Other|Diagnostic laboratory biomarker analysis|Correlative studies
16193196|NCT01447914|Other|Questionnaire administration|Ancillary studies
16193197|NCT01447914|Procedure|Quality-of-life assessment|Ancillary studies
16193198|NCT01447888|Drug|150% Oral Morphine Equivalent (OME)|Patients will receive 150% of their oral morphine equivalent (OME) utilizing the drugs Dilaudid and Fentanyl.
16193199|NCT01447888|Other|Clinical Judgment|This method of perioperative parenteral opioid dosing has been used on spine surgery patients, based on clinical decision of the anesthesiologist.
16193200|NCT01447875|Other|Passive Leg Raising|elevation of both legs to a 45 degrees for about 1-2 minute before sedation
16193201|NCT01447875|Drug|propofol or mexmedetomidine|
16193202|NCT01447862|Drug|Brinavess (Vernakalant)|3mg/kg Brinavess (Vernakalant) in 100ml normal saline over 10min. If atrial fibrillation continues after another 15 minutes of observation, patients will receive a second infusion of 2mg/kg Brinavess (Vernakalant) over 10 minutes
16193203|NCT01447862|Drug|Corvert (Ibutilide)|Patients will be given 1mg of Corvert (Ibutilide) in 100ml normal saline intravenously over 10min. If atrial fibrillation continues after another 10 minutes of observation, patients will receive a second infusion of 1mg ibutilide over 10min.
16193204|NCT01447849|Drug|lubiprostone|24mcg twice a day (BID) 1 week
16193205|NCT01447849|Drug|placebo|Placebo pills twice a day for one week.
16193206|NCT01447810|Other|Focused rigidity bi-valve long arm cast|Two focused rigidity bi-valve long arm (upper arm to finger tips) casts will be fabricated for each participant on day one of the constraint-induced therapy (CIT) program. Focused rigidity casting materials are water proof and latex/fiberglass free. Focused rigidity casting does not require use of a cast saw for removal thus decreasing potential for anxiety during the casting process. Casts will be fabricated by therapist trained in the casting technique.
16193207|NCT01447797|Drug|HCP0912 / Irbesartan and Atorvastatin|Irbesartan and Atorvastatin combination tablet / coadministration of Irbesartan and Atorvastatin
16193208|NCT01447784|Biological|ToleroMune HDM|Intradermal injection 1 x 11 administrations 4 weeks apart
16193209|NCT01447784|Biological|Placebo|Intradermal injection 1 x 11 administrations 4 weeks apart
16193210|NCT01447771|Behavioral|Decision control preference scale|At time 1, participants in the intervention group will be asked to complete the Decision Control Preference Scale.The range of decision control is measured by the Decision Control Preference (DCP) Scale. The scale is used to measure the preferred or actual role in decision making using five response statements: two represent an active or patient-controlled role, one a shared or collaborative role, and two represent a passive or provider-controlled role. The preferred level of decision making control will be known by the participant in the intervention group and the information given to the oncologist prior to the consultation regarding adjuvant therapy
16193211|NCT01447758|Drug|LEO 29102|Cream, 1,7mg/cm2 BSA, BID, 7 days In Cohort I, II and III, 6 weeks in Cohort IV
16193212|NCT01447758|Drug|LEO 29102 Cream Vehicle|Cream, 1,7mg/cm2 BSA, BID, 7 days in Cohort I and II, 6 weeks in Cohort IV
16193213|NCT01447732|Drug|CEP-37250/KHK2804|"Part 1 is based on the CEP-37250/KHK2804 tolerability and safety data from three subjects enrolled in a cohort, enrollment at the next dose level or additional subjects into the ongoing cohort will occur based upon the number subjects with DLT at a given dose level. Dose depends on subject's body weight. Part 1 includes intervention of CEP-37250/KHK2804.
~Part 2 will receive CEP-37250/KHK2804 at a dose to be determined following completion of Part 1."
16193214|NCT01447719|Drug|florbetapir F 18|No study drug administered in this trial. Study subjects previously dosed with 18F-AV-45 in study 18F-AV-45-A07 (NCT00857415) are followed to autopsy in this extension study.
16193215|NCT01447706|Drug|MM-121|MM-121 (SAR256212) (IV)
16193216|NCT01447706|Drug|Paclitaxel|Standard dosing Paclitaxel (IV)
16193217|NCT01447693|Procedure|application of ointment (olive-omega 3 ointment)|
16193218|NCT01447667|Procedure|Magnetic resonance elastography|Magnetic resonance elastography before RFA and Liver biopsy of 2 HCC tissue and 2 non tumor liver parenchyma tissue
16193219|NCT01447654|Drug|Losartan|100 mg for 12 months.
16193220|NCT01447654|Drug|Placebo|100 mg for 12 months.
16193221|NCT01447641|Other|Polysomnography|Overnight physiological recording of sleep
16193222|NCT01447641|Other|Actigraphy|Wristwatch activity to measure basic rest activity cycle and sleep efficiency
16193223|NCT01447628|Drug|Saline|intravenous, no active drug
16193224|NCT01447628|Drug|Ferinject or CosmoFer|Intravenous, 1000 mg iron
16193225|NCT01447615|Behavioral|Bridges|Each child participant in the Bridges Arm will receive the usual care in addition to a Child Development Account (CDA) to be used for secondary education by the AIDS-orphaned child. The CDA will be a matched savings account held in the child's name in a financial institution registered by the Central Bank (Bank of Uganda). The account will be matched with money from the program at a match rate of 1:1. Additionally, participants will receive: 1) twelve 1-2 hour workshops focused on asset building, future planning, and protection from risks; 2) mentorship sessions to reinforce learning and build optimism; and 3) a family income-generating /micro-enterprise promotion component for children enrolled in Bridges and their families.
16193226|NCT01447615|Behavioral|Bridges PLUS|Each child participant in the Bridges PLUS Arm will receive the usual care in addition to a Child Development Account (CDA) to be used for secondary education by the AIDS-orphaned child. The CDA will be a matched savings account held in the child's name in a financial institution registered by the Central Bank (Bank of Uganda). The account will be matched with money from the program at a match rate of 2:1. Additionally, participants will receive: 1) twelve 1-2 hour workshops focused on asset building, future planning, and protection from risks; 2) mentorship sessions to reinforce learning and build optimism; and 3) a family income-generating /micro-enterprise promotion component for children enrolled in Bridges PLUS and their families.
16193227|NCT01447615|Other|Usual Care|Participants in the usual care condition will receive usual care for AIDS-orphaned children in the study area. This includes: counseling, school lunches, and scholastic materials (textbooks and notebooks). Counseling will be provided by priests in the community (as is currently done).
16193228|NCT01447602|Behavioral|IPT-A|Interpersonal Psychotherapy for adolescents (IPT-A) is a guideline based treatment with established efficacy as an intervention for adolescent depression
16193229|NCT01447589|Drug|nelfinavir|Nelfinavir tablets BD 7 days per week from D-7 of starting radiotherapy until completion of radiotherapy on D47. 3 dose levels: 750 mg bd; 1000 mg bd; and 1250 mg bd.
16193230|NCT01447589|Radiation|Radical Radiotherapy|Total dose of 66 Gy delivered in 33 fractions (2.0 Gy/fraction) to the primary tumour plus a margin.
16193231|NCT01447576|Drug|ADT|Once daily dosing during the duration of the study.
16193232|NCT01447576|Drug|OPC-34712|OPC-34712, Oral Tablets, 0.25 - 3 mg
16193233|NCT01447563|Drug|Clopidogrel bisulfate|subjects received a single 75 mg tablet of the reference formulation, given with 250 mL water
16193234|NCT01447563|Drug|Clopidogrel|subjects received a single 75 mg tablet of the test formulation, given with 250 mL water
16193235|NCT01447550|Drug|Bosentan|Bosentan therapy consisted of a month's treatment with 62.5 mg bid orally administered. Dose doubled to 125 mg bid after the first month. The full-dose regimen (125 mg/12h) was maintained for the following months or until total healing fo the ulcers.
16193236|NCT01447537|Other|Exercise + relaxation|Exercise + relaxation
16193237|NCT01447537|Other|Relaxation|Relaxation without exercise Patients will receive only relaxation for 3 months
16193238|NCT01447524|Behavioral|Very Low Calorie Diet|Very Low Calorie Diet consisted of a 400 kcal/day diet, with percentage distribution of lipids, proteins and carbohydrates, according to Italian Standards of Care.
16193239|NCT01447511|Drug|Control - Warfarin only|A single 10 mg warfarin dose taken at the start of the study period. No other medications taken during this study period.
16193240|NCT01447511|Drug|Fluconazole - Warfarin|A single 10 mg warfarin dose taken at the start of the study period. 400 mg fluconazole taken every morning starting a week before the start of the study period and continuing throughout the study period.
16193241|NCT01447511|Drug|Rifampin - Warfarin|A single 10 mg warfarin dose taken at the start of the study period. 300 mg rifampin taken every morning starting a week before the start of the study period and continuing throughout the study period.
16193242|NCT01447498|Other|Screening for risk factors for ulcer bleeding|"Following PCI the patients fill out a questionnaire to assess the risk factors for ulcer bleeding.We randomise between:
~screening and risk assessment
~control group
~All screened patients, who fulfil the criteria for having a moderate to high risk of ulcer bleeding will be sent written information about risk factors and the purpose of the PPI prophylaxis. They will be recommended PPI prophylaxis (Pantoprazole), as long as they are being treated with low-dose aspirin and clopidogrel.
~Patients in the screening group, who are already on PPI treatment is recommended to change to Pantoprazole.
~Definition of risk of ulcer bleeding: The table below will be used for screening. Patients scoring ≥ 2 points will receive PPI prophylaxis.
~points: Age: < 60: 0; 60-69: 1; 70-79: 2; >=80: 3 ___ Dyspepsia: 1 ___ Uncomplicated ulcer: 2 ___ Complicated ulcer 3 ___ NSAID 2 ___ Steroids 2 ___ SSRI 2 ___ Anticoagulant Tx 2 ___"
16193243|NCT01447485|Drug|Valsartan (VAL489)|
16193244|NCT01447472|Drug|MDMA|One single dose of MDMA ( 1.5 mg/kg; range: 75-100 mg)
16193245|NCT01447459|Behavioral|Reinforced Asthma Education|"Before beginning the actual study, a board-certified Asthma Educator (AE) will prepare and administer an asthma education training session for the study personnel, including the PI, the co-investigators, and the study coordinator. The AE will also make herself available via pager for assistance with questions from the study personnel regarding asthma education.
~At the end of the administration of the phone surveys (i.e. at 2 weeks, 1 month and 3 months following enrollment), the study coordinator will provide reinforced asthma education to the caregiver via telephone for the subjects enrolled in Group A (the intervention group). The reinforced asthma education will be consistent with the asthma education training session delivered by the AE before the beginning of the study."
16193246|NCT01447446|Drug|Peg-IFN Alfa-2a|Peg-IFN Alfa-2a according to standard of care and in line with local labeling.
16193247|NCT01447446|Drug|Peg-IFN Alfa-2b|Peg-IFN Alfa-2b according to standard of care and in line with local labeling.
16193248|NCT01447446|Drug|Ribavirin|Ribavirin according to standard of care and in line with local labeling.
16193249|NCT01447446|Drug|Boceprevir|Boceprevir according to standard of care and in line with local labeling.
16193250|NCT01447446|Drug|Telaprevir|Telaprevir according to standard of care and in line with local labeling.
16193251|NCT01447433|Drug|Calcium Carbonate|tablet, 600mg elemental calcium and 125IU vitamin D, once daily, for 12 weeks
16193252|NCT01447433|Behavioral|Energy restriction|A balanced diet contains 500kcal of caloric deficit based on daily energy expenditure.
16193253|NCT01447420|Drug|peginterferon alfa-2a|180 mcg sc weekly, 48 weeks
16193254|NCT01447420|Drug|ribavirin [Copegus]|1'000 or 1'200 mg orally daily, 48 weeks
16193255|NCT01447407|Biological|NDV-3 vaccine with alum IM|One dose administered IM
16193256|NCT01447407|Biological|NDV-3 vaccine without alum IM|One dose administered IM
16193257|NCT01447407|Biological|Placebo with alum IM|One dose administered ID
16193258|NCT01447407|Biological|NDV-3 vaccine without alum ID|One dose administered ID
16193259|NCT01447394|Biological|Pegylated Interferon Lambda|Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks
16193260|NCT01447394|Biological|Pegylated Interferon Alfa-2a|Syringe, Subcutaneous, 180 μg, Once weekly, 48 weeks
16193261|NCT01447394|Drug|Ribavirin|Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks
16193262|NCT01447368|Drug|Cinacalcet|oral cinacalcet 25mg once daily as a start and up titrated by 25mg daily according to response in lowering PTH and maximum oral dose allowed is 100mg daily
16193263|NCT01447368|Procedure|Surgical total parathyroidectomy with forearm autografting|Surgical total parathyroidectomy with forearm autografting will be performed
16193264|NCT01447355|Drug|cholecalciferol|Given PO
16193265|NCT01447342|Device|Cryo-Touch II|Percutaneous treatment with the device
16193266|NCT01447329|Other|Ear Acupuncture|Ear acupuncture utilizes up to 10 needles. The ear Acupuncture points on the right ear include Cingulate gyrus, thalamus, omega 2, shen-men, point zero. The ear Acupuncture points on the left ear include Cingulate gyrus, thalamus, omega 2, shen-men, point zero. The subject will receive five needles intra-operatively on each ear.
16193267|NCT01447329|Drug|Standard Treatment|
16193268|NCT01447316|Other|Subject outcomes following bariatric surgery|Subject outcomes (body composition, gait analysis, lower extremity joint pain and perceived quality of life) measured at per-op, 2, 4 weeks and 3 months.
16193269|NCT01447303|Other|Subject outcomes following viscosupplementation of the knee|The study subject outcomes (WOMAC, VAS, SF-36, Chair rise, Stair climb, Six minute walk and Gait analysis) measured at 1, 3, 6 and 12 months following viscosupplementation of the knee
16193270|NCT01447277|Procedure|Sciatic Block|Performing a sciatic block in addition to a femoral block preoperatively
16193271|NCT01447277|Procedure|Femoral Block only|Performing a preoperative sciatic nerve block only
16193272|NCT01447264|Procedure|Land exercises|3 times a week. 50 minutes in every session. Performed by educational professor
16193273|NCT01447264|Procedure|Water exercises|3 times a week. 50 minutes in every session. Performed by educational professor
16193274|NCT01447251|Behavioral|PreDx Diabetes Risk Score|The PreDx DRS measures 7 predictive biomarkers -Adiponectin, C-reactive protein (CRP), Ferritin, Glucose, Insulin, IL-2 and HbA1c, using a proprietary algorithm a risk score in order to calculate a risk score. There are three risk strata, with low risk defined as PreDx DRS <4.5, moderate risk as PreDx DRS ≥4.5 and <8.0, and high risk as PreDx DRS ≥8.0.
16193275|NCT01447238|Device|Direct visualization and needle based confocal laser-induced endomicroscopy miniprobe|"Patients will undergo the EUS-FNA procedure, as per standard of care, plus an additional direct visualization (fiber optic probe) and nCLE procedure with the prototype probes, which will add 10 minutes maximum to the EUS-FNA procedure.
~The probes will be positioned against the lining of the pancreatic cyst, and images will be acquired. After imaging, fine needle aspiration of the lesion will be performed, as usual."
16193276|NCT01447225|Drug|MM-121|MM-121 administered at 20 mg/kg IV loading dose followed by12mg/kg/week IV or 40 mg/kg IV loading dose followed by 20mg/kg/week IV
16193277|NCT01447225|Drug|Carboplatin|administered at AUC 6
16193278|NCT01447225|Drug|Pemetrexed|administered IV at 500 mg/m2
16193279|NCT01447225|Drug|Cabazitaxel|administered IV at 20 mg/m2 or 25 mg/m2
16193280|NCT01447225|Drug|Gemcitabine|administered IV at 1000 mg/m2 or 1250 mg/m2
16193281|NCT01447212|Drug|Hydromorphone, Injectable|Phase I: 3x daily, up to 500mg per day, for 6 months. Phase II: At 6 months, participants are randomized to either: 1) stay on injectable hydromorphone; 2) switch to oral hydromorphone, for another 6 months.
16193282|NCT01447212|Drug|Diacetylmorphine, injectable|Phase I: 3x daily, up to 1,000mg per day, for 6 months. Phase II: At 6 months, participants are randomized to either: 1) stay on injectable diacetylmorphine; 2) switch to oral diacetylmorphine, for another 6 months.
16193283|NCT01447212|Drug|Hydromorphone, liquid oral|Study Phase II: After 6 months of receiving Hydromorphone injectable , participants will be randomized to stay on injectable hydromorphone or switch to oral hydromorphone, for another six months. Oral = experimental; injectable = active comparator
16193284|NCT01447212|Drug|Diacetylmorphine, liquid oral|Study Phase II: After 6 months of receiving Diacetylmorphine injectable, participants will be randomized to stay on injectable Diacetylmorphine or switch to oral Diacetylmorphine, for another six months. Oral = experimental; injectable = active comparator
16196272|NCT01424384|Drug|GSK424887|Neurophysiological testing
16193285|NCT01447199|Behavioral|Health and Diet Questionnaire|Mailed questionnaires asking about foods eaten, cooking methods as well as overall health, and vitamin/medication use, taking several hours to complete.
16193286|NCT01447186|Behavioral|Post-Test Questionnaire|Questionnaire following Demographic questionnaire, Pre-Test Knowledge Questionnaire and slide set review.
16193287|NCT01447186|Behavioral|Interviews|Using draft slide set, participants engage in think-aloud exercises, where each slide is reviewed and described.
16193288|NCT01447186|Behavioral|Focus Groups|Up to 40 subjects will participate in the formative focus groups. Each group will be scheduled with 6 to 10 participants to explore Hispanic men's beliefs and concerns about prostate cancer and early detection.
16193289|NCT01447173|Drug|Vitamin D|Vitamin D 2000 IU daily pill Vitamin D 400 IU daily pill
16193290|NCT01447160|Drug|Cortisone|intraarticular infiltration with 1ml of triamcinolone hexacetonide versus intramuscular injection with 1 ml of triamcinolone acetonide
16193291|NCT01447147|Drug|Placebo|Placebo capsules once daily
16193292|NCT01447147|Drug|CCX140-B|CCX140-B capsules once daily (Group B)
16193293|NCT01447147|Drug|CCX140-B|CCX140-B capsules once daily (Group C)
16193294|NCT01447121|Device|Tatsu/Tradewind Investigational BG Monitoring System|Tradewind is a Bayer investigational meter that used an investigational sensor.
16193295|NCT01447108|Device|Low Intensity Low Frequency Surface Acoustic Wave Ultrasound (PainShield™)|"All subjects will be treated four weeks with a placebo PainShield™ while continuing with their current pharmaco- analgesic regimen. Aferterwards all subjects will be crossed over to active Painshield™ therapy for the next four weeks.
~The Painshield™ device is a patch, which will be applied to their forehead for six-eight hours during night while sleeping."
16193296|NCT01447095|Drug|Prostacyclin 1 ng/kg/min|Continuous i.v. infusion of epoprostenol 1 ng/kg/min day 5-10 after SAH
16193297|NCT01447095|Drug|Prostacyclin 2 ng/kg/min|Continuous i.v. infusion of epoprostenol 2 ng/kg/min day 5-10 after SAH
16193298|NCT01447095|Drug|Placebo|Continuous i.v. infusion with placebo day 5-10 after SAH
16193299|NCT01447069|Drug|Salbutamol|The initial dose will be 0.5mg bid, with acceleration of the dose every two weeks by 1mg, up to a maximal dose of 2mg bid or an increase in heart rate by 50% above the baseline heart rate, as long as it remains <100 bpm
16193300|NCT01447056|Biological|LMP specific T cells|"Three dose levels will be evaluated:
~Dose Level 1: 2×10^7 cells/m2; Dose Level 2: 1×10^8 cells/m2; Dose Level 3: 2×10^8 cells/m2
~If patients have a partial response or have stable disease they will be eligible to receive up to 5 further doses of CTLs, each of which will consist of the same number as their first injection."
16193301|NCT01447043|Drug|Ranibizumab|Patients with wet AMD treated with ranibizumab as prescribed by physician
16193302|NCT01447017|Drug|DPK-060|DPK-060 2% ear drops were administered as 3 applications per day into the outer ear by use of a single-dose pipette (0.3 mL/pipette) for 7 days. In case clinical symptoms remained after 7 days of treatment, the treatment period was extended by another 3 days with 3 applications per day.
16193303|NCT01447017|Drug|Placebo for DPK-060 ear drops|Placebo for DPK-060 ear drops were administered as 3 applications per day into the outer ear by use of a single-dose pipette (0.3 mL/pipette) for 7 days. In case clinical symptoms remained after 7 days of treatment, the treatment period was extended by another 3 days with 3 applications per day.
16193304|NCT01446991|Drug|Degarelix|240 mg loading dose followed by monthly 80 mg maintenance dose for 2-3 months
16193305|NCT01446991|Drug|Degarelix|240 mg loading dose of Degarelix followed by 80 mg maintenance doses every month for a total duration of 6 months.
16193306|NCT01446978|Biological|hepatitis A vaccine|3 doses of hepatitis A vaccine, given at 0+1+6 months
16193307|NCT01446978|Biological|hepatitis A vaccine|Two doses of hepatitis A vaccine given at day 0, one in each M deltoids. An additional dose will be given at 6 months later
16193308|NCT01446965|Device|wearable defibrillator|LifeVest wearable defibrillator
16193309|NCT01446952|Drug|Vitamin E δ-Tocotrienol|The first cohort will be dosed with δ-tocotrienol at 200 mg. A minimum of 3 participants is planned for each dosing cohort with Vitamin E δ-Tocotrienol dose escalation dependent on safety from prior cohorts.
16193310|NCT01446926|Biological|Pneumococcal Vaccine High Dose (Formulation 1)|0.5 mL, Intramuscular
16193311|NCT01446926|Biological|Tris buffered saline (Placebo)|0.5 mL, Intramuscular
16193312|NCT01446926|Biological|Pneumococcal Vaccine High Dose (Formulation 1)|0.5 mL, Intramuscular
16193313|NCT01446926|Biological|Tris buffered saline (Placebo)|0.5 mL, Intramuscular
16193314|NCT01446926|Biological|Pneumococcal Vaccine Low Dose (Formulation 2)|0.5 mL, Intramuscular
16193315|NCT01446926|Biological|Tris buffered saline (Placebo)|0.5 mL, Intramuscular
16193316|NCT01446926|Biological|Pneumococcal Vaccine Middle Dose (Formulation 3)|0.5 mL, Intramuscular
16193317|NCT01446926|Biological|Pneumococcal Vaccine Middle Dose (Formulation 4)|0.5 mL, Intramuscular
16193318|NCT01446926|Biological|Tris buffered saline (Placebo)|0.5 mL, Intramuscular
16193319|NCT01446926|Biological|Pneumococcal Vaccine High Dose (Formulation 1)|0.5 mL, Intramuscular
16193320|NCT01446926|Biological|Tris buffered saline (Placebo)|0.5 mL, Intramuscular
16193321|NCT01446913|Device|Standard CPAP Intervention|
16193322|NCT01446913|Behavioral|Enhanced CPAP Intervention|
16193323|NCT01446900|Drug|Rituximab|375mg/mq, IV on day 1 of each 28 day cycle for 4 cycles. 375 mg/mq IV every 2 months for a total of 8 administrations as additional infusions for patients, who achieve a partial response or complete response after the therapy with R- 2-CdA.
16193324|NCT01446900|Drug|Cladribine|0,1 mg/Kg, SC from day 1 to day 5 of each 28 day cycle for 4 cycles.
16193325|NCT01446887|Other|prophylactic anticoagulation|prophylactic anticoagulation by rivaroxaban
16193326|NCT01446874|Drug|0.12% chlorhexidine solution|Toothbrushing 3 times/day for at least 5 days preoperatively using a 0.12% chlorhexidine solution and for the duration of the hospitalization or 5 days postoperatively.
16193327|NCT01446848|Dietary Supplement|iron supplement|325 mg tablets by mouth once a day for 1 week, then twice a day for 1 week, then three times daily for the remainder of the 3-month study period.
16193328|NCT01446835|Device|nelfilcon A contact lens with print|Investigational spherical contact lens
16193329|NCT01446835|Device|etafilcon A contact lens with print|Commercially marketed (Singapore) spherical contact lens
16193486|NCT01445691|Drug|5-ALA (Gliolan)|20 mg/kg administered once 3-5 hours prior to surgery
16193330|NCT01446822|Device|Bipolar transurethral resection of the urinary bladder (PlasmaKinetic, Gyrus, Fresenius)|Lateral wall urinary bladder tumors are resected transurethrally without obturator nerve block or relaxation under general anesthesia. If resection not possible because of adductor muscle contraction, patients undergo relaxation.
16193331|NCT01446822|Device|Monopolar transurethral resection of the urinary bladder (Storz GmbH &Co., Erbotom, Purisole)|Lateral wall urinary bladder tumors are resected transurethrally without obturator nerve block or relaxation under general anesthesia. If resection is not possible because of adductor muscle contraction, patients are treated by bipolar resection. If this is still not possible, they undergo relaxation.
16193332|NCT01446809|Drug|Doxorubicin Hydrochloride|Given IV
16193333|NCT01446809|Radiation|External Beam Radiation Therapy|Undergo external beam radiation therapy
16193334|NCT01446809|Drug|Ifosfamide|Given IV
16193335|NCT01446809|Other|Laboratory Biomarker Analysis|Correlative studies
16193336|NCT01446809|Drug|Pazopanib Hydrochloride|Given PO
16193337|NCT01446809|Other|Pharmacological Study|Correlative studies
16193338|NCT01446809|Other|Placebo|Given PO
16193339|NCT01446809|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16193340|NCT01446796|Device|Implantable Cardioverter-Defibrillator (subject's pre-existing ICD)|Pacing parameters set to AAI 90
16193341|NCT01446796|Device|Implantable Cardioverter-Defibrillator (subject's pre-existing ICD)|Pacing parameters set to DDD 90-100
16193342|NCT01446783|Drug|mecasermin|0,1 ml mecasermin (10 mg/ml) is injected intratendinous into the patella tendon with ultrasound guidance.
16193343|NCT01446783|Drug|Saline|0,1 ml saline is injected intratendinous into the patella tendon with ultrasound guidance.
16193344|NCT01446770|Device|Hydrogel scaffold (MF-4181)|Following surgical removal of the ear keloid, the incision will be treated with MF-4181.
16193345|NCT01446757|Procedure|The intervention group|Medical assessment (co-morbid condition, physical and neurological examination, medication review, nutrition, and blood-tests to identify anaemia, diabetes, metabolism and liver- and kidney function); assessment of functioning (ADL/IADL, fall risk), psychological assessment (cognitive decline and depression) and assessment of social and environmental conditions. The care plan is based on the CGA and will be individualised and carried out in discussion with the patient and his/her caregivers. The care will be carried out by an inter-professional Geriatric Team with employees from both the county council and the municipality. The team consists of a core team (including geriatrician and nurse) and a support team (including a social worker, occupational therapist, dietician, pharmacist, physiotherapist, and dental hygienist). The care will involve treatment for unstable medical conditions and support of patients and their caregivers. The team will have regular team conferences.
16193346|NCT01446757|Procedure|control group|No intervention
16193347|NCT01446744|Radiation|Stereotactic ablative radiotherapy|Total dose and number of fractions will depend on the site of disease. Treatment will be given daily, or every other day, over 1 -3 weeks.
16193348|NCT01446744|Radiation|palliative radiotherapy|"Investigators should follow the principles of palliative radiotherapy as per the individual institution. Treatment recommendations are as follows:
~Brain: Whole brain radiotherapy i.e. 20 Gy in 5 fractions, 30 Gy in 10 fractions
~Lung: Palliative radiotherapy as per 2011 consensus guidelines.15 i.e. 8 Gy in 1 fraction, 20 Gy in 5 fractions, 30 Gy in 10 fractions
~Bone: Palliative radiotherapy as per 2011 consensus guidelines.16 i.e. 8 Gy in 1 fraction (most common), 20 Gy in 5 fractions, 30 Gy in 10 fractions
~Liver: 20 Gy in 5 fractions if standard institutional practice"
16193349|NCT01446731|Biological|mRNA transfected dendritic cell|"Autologues monocytes are matured into dendritic cells which are then transfected with mRNA from PSA, PAP, survivin and hTERT.
~5x 10e6 DCs are given as intradermal injections in the groin Day 8 and Day 15 in a 3 week period repeated 4 times and thereafter Day 8 in a 3 week period until progression (no maximum duration)."
16193350|NCT01446731|Drug|Docetaxel|Docetaxel 75 mg/m2 is given as an intravenous injection Day 1 every three weeks in a maximum of 12 cycles (1 cycle = 3 weeks).
16193351|NCT01446718|Biological|Gardasil vaccine|0.5ml of intramuscular vaccine in three doses
16193352|NCT01446705|Other|Active Health Information Exchange|Patients selected to share data between the VA & external healthcare agencies.
16193353|NCT01446705|Other|Non-Active Health Information exchange|Patients not selecting to share data
16193354|NCT01446679|Drug|atrovastatin|oral
16193355|NCT01446653|Behavioral|Motivational Interviewing plus feedback|Provides an MI + feedback intervention supplemented with video and brochures-based information
16193356|NCT01446653|Behavioral|Video|Video arm will provide information via documentary video
16193357|NCT01446653|Behavioral|Informational Brochure|Informational Brochures are given to participants following baseline assessment.
16193358|NCT01446640|Biological|bone marrow derived mesenchymal stem cells|Intravenous administration of up to 1x10^6 MSCs per kg; intrathecal administration of up to 1x10^6 MSCs per kg.
16193359|NCT01446627|Other|There is no intervention for this study|None, no intervention made.
16193360|NCT01446614|Biological|bone marrow derived mesenchymal stem cells|Intravenous administration of up to 6x10^5 MSCs per kg,qw,for 4 weeks
16193361|NCT01446601|Device|Hypoglossal Nerve Stimulation (HGNS) System (Apnex Medical )|The HGNS System in an investigational device that includes three implantable components: a neurostimulator, a stimulation lead, and a respiration sensing lead. The HGNS System is designed to activate the muscles in the upper airway to help keep the airway open during sleep. The HGNS System is intended for the treatment of moderate to severe OSA in individuals that have failed or do not tolerate positive airway pressure (PAP) therapy.
16193362|NCT01446588|Behavioral|Yoga Intervention|Three yoga classes per week for 8 weeks.
16193363|NCT01446562|Biological|Y90 Ibritumomab Tiuxetan RIT|40 mCi/kg
16193364|NCT01446549|Other|High intensive antigravity locomotor exercise|High intensive antigravity locomotor exercise, 3 sessions/week, for 8 weeks.
16193365|NCT01446549|Procedure|Deep Brain Stimulation|Deep Brain Stimulation implantation
16193366|NCT01446536|Other|Checklist cohort|CHF discharge checklist was used arbitrarily by their treating physicians in addition to the standard therapy
16193367|NCT01446523|Drug|placebo|Syrup, 30 ml BD for 3 months in Gr. NL
16193368|NCT01446523|Drug|Lactulose|Syrup 30 ml BD for 12 weeks
16193521|NCT01445392|Biological|Multicycle SS1P|Assigned dose level of SS1(dsFv)PE38 on days 1, 3 &amp; 5 of a 21 day cycle for 2 cycles
16193369|NCT01446510|Other|Application of VTE Risk Assessment|Use of a method to assess a patient's risk of VTE, and then appropriate prophylaxis for the assigned level of risk
16193370|NCT01446497|Drug|Brimonidine/Timolol mixed combination|Twice per day, 1 drop at each time
16193371|NCT01446497|Drug|Timolol|Twice per day, 1 drop at each time
16193372|NCT01446484|Biological|CD4+CD25+CD127lowFoxP3+ T regulatory cells injection|Blood samples from patients in the experimental group will be collected twice with weekly interval in the amount of 70 ml/1,73 m2. T cells CD4+ will be separated from blood samples and frozen in liquid nitrogen. At day 30 after transplantation patients will undergo subcutaneous injection of approximately 2x 10^8 autologous T regs, expanded from previously frozen CD4+ T cells. Levels of T reg cells in patient's blood will be estimated by flow cytometry in a week after injection. That cell injection procedure will be repeated at 6 months after transplantation
16193373|NCT01446484|Drug|Alemtuzumab|Immunosuppressant; 2 doses of drug by intravenous infusion on Days 14 - 21 before Tx and on Day 0 after Tx
16193374|NCT01446484|Drug|Mycophenolate mofetil|Immunosuppressant; oral daily dose starting Day 2-3 until withdrawal or end of the study
16193375|NCT01446484|Drug|Sirolimus|Immunosuppressant; oral daily dose starting no earlier then after Month 1 post-transplant until withdrawal or end of the study
16193376|NCT01446484|Drug|Tacrolimus|Immunosuppressant; daily dose starting Day 0 until withdrawal or end of the study
16193377|NCT01446484|Drug|Cyclosporine|Immunosuppressant; daily dose starting Day 0 until withdrawal or end of the study
16193378|NCT01446484|Drug|Everolimus|Immunosuppressant; oral daily dose starting no earlier then after Month 1 post-transplant until withdrawal or end of the study
16193379|NCT01446484|Procedure|Kidney transplantation|Living related kidney transplantation
16193380|NCT01446458|Drug|Modified FOLFIRINOX|Patients receive modified FOLFIRINOX Chemotherapy for 4 cycles (1 cycle = 15 days). Modified FOLFIRINOX: Oxaliplatin 85 mg/m2 intravenous infusion on day 1; Irinotecan 180 mg/m2 intravenous infusion on day 1; 5-Fluorouracil 2400 mg/m2 continuous intravenous infusion on days 1 to 3; pegylated filgrastim (neulasta) 6 mg subcutaneous injection on day 3.
16193381|NCT01446458|Radiation|Stereotactic Body Radiotherapy (SBRT)|Patients will receive Stereotactic Body Radiotherapy (SBRT) to pancreas tumor 2 weeks following chemotherapy. SBRT is given in 3 daily fractions at designated doses per treatment cohort. Starting dose level-Dose level 1: 10 Gy SBRT to primary tumor volume (PTV) / 2 Gy SBRT to the retroperitoneal margin daily for a total Gy to Gross tumor volume (GTV) of 36 Gy. There are weekly toxicity assessments for 4 weeks. This is a standard 3 + 3 design with 4 dose levels.
16193382|NCT01446445|Drug|Ganciclovir/ Valganciclovir according to SPC|Doses according to Summaries of Product Characteristics (SPC)
16193383|NCT01446445|Drug|Ganciclovir/ Valganciclovir according to PK model|Doses according to population pharmacokinetic model
16193384|NCT01446419|Device|Intracept Treatment|Percutaneous transpedicular RF ablation of an intraosseous nerve within the lumbar vertebral body to treat chronic axial low back.
16193385|NCT01446419|Device|Sham Treatment|Percutaneous transpedicular access to the lumbar vertebra, no RF ablation delivered.
16193386|NCT01446406|Device|MONARCA|Monitoring affective symptoms entered by the patient every day.
16193387|NCT01446406|Device|NON-MONARCA|A mobile phone for communication purposes only. No application has been installed.
16193388|NCT01446341|Procedure|Below knee plaster casting|Subjects will be randomly assigned to either immobilization of their lateral ankle sprain with a below knee cast or to enter a functional rehabilitation program
16193389|NCT01446341|Procedure|Functional rehabilitation|Subjects will be randomly assigned to either immobilization of their lateral ankle sprain with a below knee cast or to enter a functional rehabilitation program
16193390|NCT01446328|Drug|Amisulpride|Tablets, dose range 50-1200 mg/ day
16193391|NCT01446328|Drug|Aripiprazole|Tablets, dose range 5-30 mg/ day
16193392|NCT01446328|Drug|Olanzapine|Tablets, dose range 2.5-20 mg/ day
16193393|NCT01446315|Behavioral|Use of Asthma APGAR system and tools|Practices will use the Asthma APGAR control questionnaire and the care algorithm.
16193394|NCT01446315|Behavioral|Asthma APGAR tools|Usual care
16193395|NCT01446302|Dietary Supplement|Double meal|A standardized meal is served 1 h after start of HD and 1 h after end of HD.
16193396|NCT01446289|Biological|Group B Streptococcus Trivalent Vaccine|Pregnant women who received one injection of Group B Streptococcus Trivalent Vaccine administered intramuscularly.
16193397|NCT01446289|Biological|Placebo|Pregnant women who received one injection of saline solution administered intramuscularly.
16193398|NCT01446276|Dietary Supplement|Resveratrol|500 mg 3 times daily for six month
16193399|NCT01446276|Other|Placebo|1 placebo tablet 3 times daily for six month
16193400|NCT01446263|Procedure|Radial access versus femoral access for coronary angiography and intervention|Radial access or femoral access for coronary angiography and intervention in patients with prior coronary artery bypass grafts
16193401|NCT01446250|Drug|Alisporivir|ALV 200 mg soft gel capsules administered orally
16193402|NCT01446250|Drug|Boceprevir|BOC 800 mg (4 x 200 mg soft gel capsules) administered orally
16193403|NCT01446250|Drug|Peginterferon alfa-2a|PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
16193404|NCT01446250|Drug|Ribavirin|RBV 200 mg tablets (weight-based dose: < 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose
16193405|NCT01446237|Other|acne system - benzoyl peroxide 2.5%, Salicyclic Acid 0.5%|over the counter acne system
16193406|NCT01446224|Drug|Pazopanib|Patients treated with pazopanib
16193407|NCT01446224|Drug|Other anti-VEGFs|Patients treated with other anti-VEGFs including Bevacizumab, Sorafenib, and Sunitinib
16193408|NCT01446211|Drug|Gusperimus + glucocorticoids|Both severity subgroups will be treated with gusperimus + glucocorticoids up to 12 months.
16193409|NCT01446211|Drug|cyclophosphamide followed by methotrexate (azathioprine) + glucocorticoids or methotrexate (azathioprine) + glucocorticoids|"Severe subgroup: will receive intravenous cyclophosphamide pulses for at least 13 weeks and 22 weeks at maximum, followed by methotrexate + glucocorticoids after achieving a response with BVAS ≤ 2. Patients intolerant to methotrexate and patients with impaired renal function will receive azathioprine + glucocorticoids .
~Non-severe subgroup: will receive methotrexate + glucocorticoids (or azathioprine + glucocorticoids for those previously intolerant to methotrexate or with impaired renal function)."
16193410|NCT01446185|Device|Oncotype DX breast cancer test|The Oncotype DX breast cancer test measures the expression of 21 genes of an individual tumor to generate an Recurrence Score result that quantifies the magnitude of chemotherapy benefit and the likelihood of recurrence for early-stage breast cancer patients.
16193411|NCT01446159|Drug|MEDI-573|Intravenous infusion of MEDI-573 (10 or 30 or 45 mg/kg) will be administered on Day 1 of each 21-day cycle until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
16193412|NCT01446159|Drug|Aromatase Inhibitor|Aromatase inhibitor of the investigator's choice (letrozole, anastrozole, or exemestane) will be provided orally once daily until unacceptable toxicity, documentation of disease progression, or withdrawal for other reasons.
16193413|NCT01446146|Behavioral|Informed decision making|40 minute session with a clinician. Participants will learn about the available PTSD treatment options and will be given a decision aid with more information.
16193414|NCT01446146|Behavioral|Placebo session|Participant will complete clinician-administered measures in a 40-minute session.
16193415|NCT01446133|Drug|Rituximab|375 mg/m2 by vein on Day 1, Day 8, Day 15 and Day 22 and then continued once every 4 weeks during cycles 3-12 (+ 7 days). Rituximab will not be given in Cycle 2.
16193416|NCT01446133|Drug|Lenalidomide|10 mg/day by mouth daily beginning on Day 9 of cycle 1.
16193417|NCT01446120|Drug|NPH-Insulin Injection|
16193418|NCT01446120|Drug|Insulin loaded Orally Dissolved Films (insulin-ODF|
16193419|NCT01446107|Other|placement of fissure sealant|placement of resin-based fissure sealant at baseline without replacement
16193420|NCT01446107|Other|fluoride varnish|topical applications of a 5% sodium fluoride (NaF) varnish onto tooth surface every 6 months
16193421|NCT01446107|Other|silver fluoride|topical applications of a 38% silver diamine fluoride (SDF) solution onto tooth surface every year
16193422|NCT01446107|Other|placebo control|application of water onto tooth surface every year
16193423|NCT01446094|Drug|regadenoson|Intravenous administration of 0.4 mg dose of Regadenoson using per routine CMR, as indicated in the package insert.
16193424|NCT01446081|Behavioral|Exercise|Patients will receive an individualized, supervised mixed-modality exercise program created by a CSEP-Certified Exercise Physiologist (CEP). They will perform 30 minutes of light to moderate intensity exercise 4-5 times/week tailored to ability. Aerobic exercise will primarily consist of walking and/or stationary cycling. Resistance exercises will target large muscle groups using dumbbells, resistance bands, and stability balls. The CEP will monitor and document details of each exercise session as well as patient tolerance and symptoms, and make appropriate adaptations to ensure program safety and progression. Exercise intensity and duration will vary based on patient tolerance, symptoms and blood parameters. Exercise equipment will be carefully sanitized between each use.
16193425|NCT01446068|Dietary Supplement|High-fat meal|Three caloric doses of high-fat meal (500, 1000, 1500 kcal)
16193426|NCT01446055|Device|ResQ processed bone marrow sample|Autologous bone marrow is processed with ResQ at point of care, prior to the transplantation
16193427|NCT01446055|Device|Ficoll conventional cell processing method|Comparison of different cell processing methods
16193428|NCT01446042|Drug|Testosterone|Intranasal testosterone
16193429|NCT01446042|Drug|Testosterone|Intranasal testosterone
16193430|NCT01446029|Device|Video Telemonitoring Device with Clinical Care Modules|Telemonitoring of vital signs; videoconferencing, remote titration of diabetes, blood pressure, and lipid medications using evidence based treatment algorithm, and cooperative goal setting using education modules to enhance lifestyle changes
16193431|NCT01446016|Drug|Taxane|Chloroquine 250mg po daily together with Paclitaxel (Taxane) 175 mg/m2 three hours infusion every three weeks.
16193432|NCT01446016|Drug|Docetaxel|Chloroquine 250mg po daily together with docetaxel 75 mg/m2 administered intravenously over one hour every three weeks
16193433|NCT01446016|Drug|Abraxane|Chloroquine 250mg po daily together with Abraxane 260 mg/m2 administered intravenously over 30 minutes every three weeks.
16193434|NCT01446016|Drug|Ixabepilone|Chloroquine 250mg po daily together with Ixabepilone is 40 mg/m2 administered intravenously over three hours every three weeks.
16193435|NCT01446003|Drug|MK-8457|10 x 10-mg capsule BID for 10 days
16193436|NCT01446003|Drug|Placebo for MK-8457|10 x 10-mg capsule BID for 10 days
16193437|NCT01445990|Device|Lactate-meter: LactatePro (ARKRAY Inc)|Capillary glucose and lactate measurement. Every hours for the first 24 hours, and every 4 hours for the next 4 days.
16193438|NCT01445964|Drug|Atenolol|Atenolol oral administration
16193439|NCT01445964|Drug|Atenolol with apple juice 1200 mL|Atenolol oral administration with apple juice 1200 mL
16193440|NCT01445964|Drug|Atenolol with apple juice 600 mL|Atenolol oral administration with apple juice 600 mL
16193441|NCT01445951|Drug|Technosphere® Insulin with MedTone C Inhaler|Inhalation Powder and injectable insulin
16193442|NCT01445951|Drug|Technosphere ®Insulin with Gen2 Inhaler|Inhalation Powder and injectable insulin
16193443|NCT01445951|Drug|Insulin Aspart in combination with a basal insulin|Injectable insulin
16193444|NCT01445938|Drug|SAR97276A|"Pharmaceutical form:solution for injection
~Route of administration: intramuscular"
16193445|NCT01445938|Drug|arthemeter + lumefantrine (ACTs)|"Pharmaceutical form:tablet
~Route of administration: oral"
16193446|NCT01445925|Procedure|Pulmonary vein isolation (PVI)|Using a 4mm irrigated tip radiofrequency ablation catheter a series of lesions >2 mm outside pulmonary vein (PV) ostia will be made to encircle and electrically isolate the pulmonary veins in two ipsilateral pairs (wide area circumferential ablation, WACA). A 20-pole PV mapping catheter will be used to confirm electrical isolation. If the patient is in atrial fibrillation at this stage, sinus rhythm would be restored with electrical cardioversion and PVI would be confirmed in sinus rhythm
16193482|NCT01445743|Biological|Biological/Vaccine: Tdap Vaccine|Biological: Tdap Intervention comprises 104 randomly assigned pregnant women who will receive a blinded dose of Tdap vaccine (ADACEL) containing 2.5 ug of detoxified pertussis toxin (PT), filamentous haemagglutinin 5 ug, 3 ug Pertactina; 5 ug Fimbriae type 2 and 3, (in addition to Tetanus Toxoid (5 Lf) and diphtheria toxoid (2Lf) as a single 0.5 mL intramuscular injection into the deltoid.
16193483|NCT01445730|Dietary Supplement|Fructose|3 month fructose diet 75 g/day
16193485|NCT01445704|Dietary Supplement|Placebo|The placebo supplementation is identical-looking to the capsule of the probiotic supplementation.
16193662|NCT01444261|Other|control|No dietary supplements
16193447|NCT01445925|Procedure|Pulmonary vein isolation + linear lesions|Using a 4mm irrigated tip radiofrequency ablation catheter a series of lesions >2 mm outside PV ostia will be made to encircle and electrically isolate the pulmonary veins in two ipsilateral pairs (wide area circumferential ablation, WACA)34. A 20-pole PV mapping catheter will be used to confirm electrical isolation. Once PVI has been achieved, patients will go onto to receive additional linear ablation lesions. These will include a left atrial roof line, mitral isthmus line, (including ablation inside the coronary sinus if necessary), and ablation on the cavotricuspid isthmus. If the patient is in atrial fibrillation at this stage, the acute end-point would be signal obliteration at the ablated area. Once sinus rhythm is restored with electrical cardioversion, PVI would be confirmed in sinus rhythm and conduction block across the LA roof line, Mitral line and CTI will then be verified with appropriate pacing manoeuvres.
16193448|NCT01445925|Drug|Pharmacological Substrate modification|at least 6 weeks therapy with oral amiodarone prior to the ablation procedure and 6 weeks post.
16193449|NCT01445899|Drug|PF-04523655 (Stratum I)|PF-04523655 (a small interfering RNA) - a single IVT injection
16193450|NCT01445899|Drug|ranibizumab|6 monthly IVT injections of ranibizumab (Stratum II)
16193451|NCT01445899|Drug|PF-04523655 (Stratum II)|6 monthly IVT injections of PF-04523655 (a small interfering RNA)
16193452|NCT01445886|Drug|Indigo Naturalis Extract in Oil|The participants applied indigo naturalis extract in oil topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.
16193453|NCT01445886|Drug|Calcipotriol Solution|The participants applied calcipotriol solution topically to one of two bilaterally symmetrical psoriatic finger nails twice daily for 24 weeks.
16193454|NCT01445873|Drug|Sitaxentan sodium|Sitaxentan sodium 100 mg / day
16193455|NCT01445860|Drug|Simvastatin/PF-03882845|Single dose 20 mg simvastatin on Day 1, 30 mg PF-03882845 once daily from Days 2 to 13, the single dose 20 mg simvastatin on Day 12.
16193456|NCT01445847|Drug|Lidocaine|1 mg/kg or 1 mL/10 kg prior to extubation period. Injection of Lidocaine will be immediately when inhalational agent (Desflurane) is discontinued.
16193457|NCT01445847|Other|Placebo|1 mL/10 kg prior to extubation period. Injection of placebo will be immediately when inhalational agent (Desflurane) is discontinued.
16193458|NCT01445821|Biological|Peripheral Blood Stem Cells|Mobilized leukapheresis product
16193459|NCT01445821|Drug|Cyclophosphamide|An alkylating agent which causes prevention of cell division by forming adducts with DNA
16193460|NCT01445821|Drug|Mesna|Medication used to decrease the risk of hemorrhagic cystitis prophylaxis
16193461|NCT01445821|Drug|rATG|A predominantly lymphocyte-specific immunosuppressive agent which contains antibodies specific to the antigens commonly found on the surface of T cells
16193462|NCT01445821|Drug|Methylprednisolone|Steroid
16193463|NCT01445821|Drug|Filgrastim|Granulocyte-colony stimulating factor (G-CSF); a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream
16193464|NCT01445821|Drug|Fludarabine|Purine analog which inhibits DNA synthesis or repair
16193465|NCT01445808|Behavioral|Psychodynamic Motivation and Training Program (PMT)|The Psychodynamic Motivation and Training Program (PMT) is a psychodynamic stepped care approach. Depending on the individual needs PMT consists of 3 to 8 sessions of individual psychodynamic psychotherapy. If appropriate session 4 - 8 may be conducted by a nurse. PMT targets the mental and external barriers to improve physical activity by focusing on affects, interpersonal relations and maladaptive self- and other representations. PMT will be offered in addition to +Ex.
16193466|NCT01445808|Behavioral|Advice in Exercise Training (+Ex)|Advice in Exercise Training consists of one individual session of advice in exercise training based on the results of the spiroergometry.
16193467|NCT01445808|Other|Treatment as usual (TAU)|Usual care by family doctor, cardiologist
16193468|NCT01445795|Drug|200 mg INX-08189 Fasted|200 mg capsule INX-08189 fasted x7 days
16193469|NCT01445795|Drug|Placebo QD Fasted|Placebo capsule QD fasted x7 days
16193470|NCT01445795|Drug|100 mg INX-08189 QD|100 mg INX-08189 capsule QD x 7 days
16193471|NCT01445795|Drug|Placebo QD|Placebo capsule Placebo QD dosed with ribavirin x7 days (ribavirin will be dosed in a weight-based fashion as labeled BID)
16193472|NCT01445795|Drug|100 mg INX-08189 with low-fat meal|INX-08189 100 mg capsule, with low-fat meal QD for seven days
16193473|NCT01445795|Drug|Placebo with low-fat meal|Placebo capsule administered with a low-fat meal QD for seven days
16193474|NCT01445795|Drug|100 mg INX-08189 BID Fasted|100 mg INX-08189 BID fasted x7 days
16193475|NCT01445795|Drug|Placebo BID Fasted|Placebo BID fasted x7 days
16193476|NCT01445795|Drug|ribavirin|
16193477|NCT01445782|Drug|AZD2115|Multiple dose, oral inhalation (nebuliser solution)
16193478|NCT01445782|Drug|Placebo|Multiple dose, oral inhalation (nebuliser solution)
16193479|NCT01445769|Drug|Ruxolitinib|Ruxolitinib was provided as 5 mg tablets. Dose increases were only permitted at wks 12 & 18 for lack of efficacy. Increases were restricted to patients who didn't meet criteria for a dose hold over the prior 6 wks, had a platelet count ≥ 100 x 10^9/L at wk 12 or ≥ 150 x 10^9/L at wk 18, and had a self-reported PGIC score of 3 (minimally improved) to 7 (very much worse) OR the subject's palpable spleen length below the costal margin was reduced by less than 40% relative to Baseline. Dose increases were elective and not required. Subjects were permitted a dose increase of 5 mg BID to 15 mg BID at wk 12 and to a maximum of 20 mg BID at wk 18. The protocol required dose decreases for thrombocytopenia (platelets <100 x 10^9/L) or protocol-defined anemia (decline in hemoglobin of at least 2 g/dL to a level < 8 g/dL, development of transfusion dependence, or a 50% increase in transfusion requirements for transfusion dependent subjects).
16193480|NCT01445756|Drug|Lidocaine|During the procedure (placement of the IUD), 1ml of gel will be applied to the anterior lip of the cervix. After 1 minute of waiting, a tenaculum will be placed to steady the cervix. The catheter will be introduced into the cervical canal, past the external os and 1-1.5ml of gel will be placed into the canal. After another minute, the IUD will be placed in the standard fashion.
16193481|NCT01445756|Drug|Placebo|Placebo; no topical lidocaine administered
16193484|NCT01445704|Dietary Supplement|Probiotics|"The probiotic supplementation will use lactic acid bacteria in the ProbioMax DF™ supplement from Xymogen, Inc. This preparation consists of a four-strain probiotic with 100 billion CFU per vegetable capsule. The strains included are Lactobacillus acidophilus La-14, Bifidobacterium lactis HN019, Lactobacillus planarum Lp-115, and Bifidobacterium longum B1-05."
16193487|NCT01445678|Drug|CXA-201 and metronidazole|CXA-201 IV infusion (1500mg q8h) and metronidazole IV infusion (500mg q 8h) for 4-14 days
16193488|NCT01445678|Drug|Meropenem|Meropenem IV infusion (1000mg q8h) for 4-14 days
16193489|NCT01445652|Device|nelfilcon A contact lens|Commercially marketed, single vision, soft contact lens for daily disposable wear
16193490|NCT01445652|Other|Spectacles|Spectacles per current prescription
16193491|NCT01445639|Drug|Dexmedetomidine|Intravenous infusion at rate of 0.4μg/kg/h, during the first 24 hours postoperatively
16193492|NCT01445639|Drug|Normal saline|as placebo
16193493|NCT01445626|Drug|dexamethasone intravitreal implant 0.7 mg|Dexamethasone intravitreal implant 0.7 mg was dosed previously according to general clinical practice.
16193494|NCT01445613|Device|RX Acculink Carotid Stent System (RX Acculink)|Those patients receiving the RX Acculink used with an Embolic Protection System (EPS) approved for use with RX Acculink.
16193495|NCT01445600|Drug|ALTARGO(retapamulin)|Basically there is no treatment allocation. Subjects who would be administered of ALTARGO(retapamulin) at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.
16193496|NCT01445587|Drug|Part 1; Cohort 1|On Cycle 0, Day -3, three subjects will be enrolled to receive a single oral dose of 125mg GSK2110183. After the 72 hour PK sampling is completed, the subjects will continue the 125mg GSK2110183 dose daily for 21 day cycles. If none of the 3 subjects experience one of the DLTs listed in the protocol during Cycle 1, the dose will be escalated to 150mg GSK2110183 for the subject enrolled to Cohort 2. Alternately, if 1 subject reports a DLT, then 3 more subjects will be enrolled at the same dose. If 2 of 6 subjects report a DLT, then the MTD has been exceeded. Subjects will remain on study until they meet one of the Treatment Discontinuation Criteria.
16193497|NCT01445587|Drug|Part 1; Cohort 2|For Cohort 2, on Cycle 0, Day -3, three subjects will be enrolled to receive a single oral dose of 150mg GSK2110183. After the 72 hour PK sampling is completed, the subjects will continue the 150mg GSK2110183 dose daily for 21 day cycles. If none of the 3 subjects experience one of the DLTs listed in the protocol during Cycle 1, the MTD will be determined unless the PK and Pharmacodynamic data indicates another dose level should be evaluated. Alternately, if 1 subject reports a DLT, then 3 more subjects will be enrolled at the same dose. If 2 of 6 subjects report a DLT, then the MTD has been exceeded. Subjects will remain on study until they meet one of the Treatment Discontinuation Criteria.
16193498|NCT01445587|Drug|Part 2; Stage 1|Following the completion of PK sampling and the determination of a Recommended Phase 2 Dose (RP2D) of GSK2110183 in Cohorts 1 and 2, subjects will be enrolled into Part 2, Stage 1 of the study. Twenty subjects will be enrolled in Stage 1. If no subject responds, the study will be stopped; otherwise, the study will continue enrollment of Stage 2.
16193499|NCT01445587|Drug|Part 2, Stage 2|Twenty subjects will be enrolled in Part 2, Stage 2. If 4 or fewer of the 40 subjects (Stages 1 and 2) respond, the study will not be deemed as a success for GSK2110183 monotherapy. However, those subjects meeting the criteria for progression (as defined by IMWC Panel 1) who also meet the additional eligibility criteria for salvage therapy may proceed to GSK2110183 + bortezomib salvage therapy. GSK2110183 + bortezomib salvage therapy will be continued until one of the Treatment Discontinuation Criteria is met
16193500|NCT01445561|Drug|Interleukin-2 (100,00 IU/m(2) SQ)|100,000 International Units/m2 SQ daily for 5 days
16193501|NCT01445548|Drug|Sirolimus|
16193502|NCT01445535|Biological|Rituximab|Rituximab will be given with siplizumab and etoposide, prednisone, vincristine, cyclophosphamide, and doxorubicin every 21 days
16193503|NCT01445535|Drug|Etoposide|Etoposide will be given with siplizumab and prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab every 21 days
16193504|NCT01445535|Biological|Siplizumab|Siplizumab will be given with etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin and rituximab every 21 days
16193505|NCT01445535|Drug|Prednisone|Prednisone will be given with siplizumab and etoposide, vincristine, cyclophosphamide, doxorubicin and rituximab every 21 days
16193506|NCT01445535|Drug|Vincristine|Vincristine will be given with siplizumab and etoposide, prednisone, cyclophosphamide, doxorubicin and rituximab every 21 days
16193507|NCT01445535|Drug|Cyclophosphamide|Cyclophosphamide will be given with siplizumab and etoposide, prednisone, vincristine, doxorubicin and rituximab every 21 days
16193508|NCT01445535|Drug|Doxorubicin|Doxorubicin will be given with siplizumab and etoposide, prednisone, cyclophosphamide and rituximab every 21 days
16193509|NCT01445522|Drug|ABT-888|
16193510|NCT01445522|Drug|Cyclophosphamide|
16193513|NCT01445444|Behavioral|Habit Reversal Training|"8 weekly therapy sessions lasting 50 minutes based on the protocol outlined by Woods (2001).
~The overall focus of treatment is to provide patients with tools to help them manage and reduce hair-pulling.
~components:
~Session 1. (a) to develop an understanding of the subject's hair-pulling through an initial interview; and (b) to establish a protocol for ongoing assessment.
~Session 2. implement habit reversal, including awareness training, competing response training, and social support.
~Sessions 3-8. For subjects with a single hair-pulling site, Session 3 will review and practice HRT procedures and name solutions to problems that may have arisen. For those with multiple hair-pulling sites, treatment will be reviewed for the first site in the hierarchy."
16193514|NCT01445431|Other|Virgin Coconut Oil|Virgin coconut oil applied to the test site twice daily for four weeks
16193515|NCT01445431|Other|Mineral Oil|Mineral oil applied to the test site twice daily for four weeks
16193516|NCT01445418|Drug|AZ2281 + Carboplatin|Cohort 1: Dose escalation: AZD2281 po bid qd + IV carboplatin D8 of each 21-day cycle.; Cohort 2: Expanded cohort treated at the MTD of the combination identified in Cohort 1.
16193517|NCT01445405|Drug|Bortezomib (Velcade, PS-341)|
16193518|NCT01445405|Drug|Cetuximab|
16193519|NCT01445405|Drug|Cisplatin|
16193520|NCT01445405|Procedure|Radiation Therapy|
16193522|NCT01445392|Drug|Pemetrexed|500 mg/m^2 on day 1 of each 21 day cycle until disease progression
16193523|NCT01445392|Drug|Cisplatin|75 mg/m^2 on day 1 of each 21 day cycle until disease progression
16193524|NCT01445392|Biological|Single cycle SS1P|Patients 1 - 3 of single cycle cohort. 45 mcg/kg of SS1(dsFv)PE38 on 4 or 5 days (depending on dose level) of cycle 1 only.
16193525|NCT01445379|Drug|Ipilimumab|Dose Level Escalation: 1mg/kg, 3mg/kg, 5mg/kg, 10mg/kg
16193526|NCT01445366|Device|High volume post dilution hemodiafiltration|The midweek dialysis sessions of the patients is changed once to a 4 hours high volume post dilution hemodiafiltration (HDF) session, and once to an 8 hours high flux hemodialysis (HD) session.
16193527|NCT01445366|Device|high flux hemodialysis|The midweek dialysis sessions of the patients is changed once to a 4 hours high volume post dilution hemodiafiltration (HDF) session, and once to an 8 hours high flux hemodialysis (HD) session.
16193528|NCT01445340|Drug|Romidepsin (FR901228)|
16193529|NCT01445301|Drug|GSK2585823(CLDM 1%-BPO 3% gel)|Topical gel in 1 g containing clindamycin 10 mg and benzoyl peroxide 30 mg
16193530|NCT01445301|Drug|CLDM 1% gel twice daily|Topical gel containing clindamycin 10 mg/1 g gel
16193531|NCT01445275|Procedure|Evaluation of Cancer Risk Factors|Ancillary studies
16193532|NCT01445275|Other|Medical Chart Review|Ancillary study
16193533|NCT01445275|Other|Study of Socioeconomic and Demographic Variables|Ancillary studies
16193534|NCT01445262|Drug|Levocetirizine|
16193535|NCT01445249|Procedure|Landmark guided ankle block.|25-30mls 0.5% levobupivacaine will be infiltrated to provide a landmark guided ankle block.
16193536|NCT01445249|Procedure|PNS guided block.|This group will have 25-30mls of 0.5% levobupivacaine infiltrated as directed by peripheral nerve stimulation.
16193537|NCT01445236|Other|Immunosuppresion withdrawal|Gradual discontinuation of all immunosuppressive drugs.
16193538|NCT01445223|Drug|Lopinavir ritonavir|400mg BD 100mg BD
16193539|NCT01445223|Drug|Atazanavir ritonavir|300mg QD 100mg QD
16193540|NCT01445223|Drug|Efavirenz|600mg QD
16193541|NCT01445210|Procedure|Continuous saphenous nerve block|0,2% Ropivacaine by elastomeric infusion pump at 5 ml/h for 48 postoperative hours
16193542|NCT01445210|Procedure|Placebo|Isoton saline by elastomeric infusion pump at 5 ml/h for 48 postoperative hours
16193543|NCT01445197|Biological|Biostate|200 IU/kg administered daily
16193544|NCT01445171|Device|Aortic Valve Replacement with EDWARDS INTUITY Valve System|Aortic Valve bioprosthesis
16193545|NCT01445132|Drug|Allogeneic Cell Therapy w/ Tumor-derived Lypho|
16193546|NCT01445119|Drug|Enzastaurin (LY317615)|
16193547|NCT01445119|Drug|Carboplatin|
16193548|NCT01445106|Drug|Nelfinavir|
16193549|NCT01445106|Drug|Nelfinavir Mesylate|
16193550|NCT01445080|Other|Laboratory Biomarker Analysis|Correlative studies
16193551|NCT01445080|Other|Pharmacological Study|Correlative studies
16193552|NCT01445080|Drug|Sorafenib Tosylate|Given orally
16193553|NCT01445067|Drug|BMS-927711 (CGRP Antagonist)|Capsule, Oral, 300 mg, Once, One day
16193554|NCT01445067|Drug|BMS-927711 (CGRP Antagonist)|Capsule, Oral, 600 mg, Once, One day
16193555|NCT01445054|Drug|111Indium CHX-A|111Indium CHX-A will be administered intravenously over a 10-15 minute period using an intravenous catheter
16193556|NCT01445041|Biological|Autologous Umbilical Cord Blood|Infants who meet study enrollment criteria for hypoplastic left heart syndrome in the neonatal period will receive 1 infusion of their own volume reduced cord blood cells. The dose for each infusion is 5x10e7 cells/kg.
16193557|NCT01445041|Biological|Autologous Umbilical Cord Blood|Infants who meet study enrollment criteria for hypoplastic left heart syndrome in the neonatal period will receive 3 infusions of their own volume reduced cord blood cells. The first infusion will be a fresh, volume-reduced infusion and the subsequent infusions will be thawed and washed infusions. The dose for each infusion is 5x10e7 cells/kg.
16193558|NCT01445028|Drug|Isotretinoin|Isotretinoin 20mg daily for 12 weeks
16193559|NCT01445015|Behavioral|Stress management program|10 session intervention utilizing a cognitive behavorial program with a goal of stress reduction
16193560|NCT01445015|Other|Peer viewed movies|PG rated movies to be viewed over 10 sessions in peer setting
16193561|NCT01445002|Biological|BM32|Subcutaneous injection of 10 micrograms each of the BM32 components adsorbed on 0.3 mg of aluminum hydroxide every 4 week for a total of 3 injections
16193562|NCT01445002|Biological|BM32|Subcutaneous injection of 20 micrograms of each of the BM32 components adsorbed on 0.6 mg of aluminum hydroxide every 4 weeks for a total of 3 injections
16193563|NCT01445002|Biological|BM32|Subcutaneous injection of 40 micrograms of each of the BM32 components adsorbed on 1.2 mg of aluminum hydroxide every 4 weeks until a total of 3 injections
16193564|NCT01445002|Biological|Placebo|Subcutaneous injection of 1.2 mg of aluminum hydroxide suspension every 4 weeks until 3 injections
16193565|NCT01444989|Other|AKRQ questionnaire|The AKRQ is an experimental instrument composed of 10 questions that assess quality of life and risk factors
16193566|NCT01444989|Other|Skindex-16, DLQI, Skin Health Calculator|These are all previously validated questionnaires
16193567|NCT01444976|Drug|local anesthesia|patients will receive only topical anesthesia with 1% lidocaine
16193568|NCT01444976|Behavioral|hypnosis|Hypnosis will be performed by the same anesthesiologist according to indirect Erickson's method
16193569|NCT01444976|Drug|Midazolam|Before insertion of the probe, the patients will be sedated with midazolam at a dose of 0,.05 mg/kg iv (to achieve a Ramsay Sedation Score of 2-3). If needed, additional iv doses (0.005 mg/kg) were given during the procedure.
16193570|NCT01444924|Drug|Bupivicaine|The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis
16193571|NCT01444924|Drug|Placebo|The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline.
16193572|NCT01444911|Device|Vaginal Renewal Program|The Vaginal Renewal™ Program (VRP) consists of instructions on the use of a vibrating vaginal wand along with a particular water based lubricant.
16193573|NCT01444911|Device|Vaginal Dilator|Still vaginal dilator with lubricant.
16193574|NCT01444898|Drug|Exenatide|The investigators will give patients naive to GLP-1 agonists exenatide per manufacturer dosing recommendations for 6 months. The investigators will begin by giving 5 mcg subcutaneously twice a day for 1 month and then increase the dose to 10 mcg subcutaneously twice a day for the remainder of the study (5 months).
16193575|NCT01444885|Drug|Placebo|2 weeks treatment of Cilostazol 100mg, or placebo oral tablets bid after 2 weeks treatment of Cilostazol 50mg, or placebo oral tablets bid (Total 4 weeks)
16193576|NCT01444872|Drug|TRV120027|IV infusion
16193577|NCT01444872|Drug|Normal Saline|IV infusion
16193578|NCT01444859|Dietary Supplement|Trenev Trio®/Healthy Trinity®|Trenev Trio®/Healthy Trinity® (1 capsule, 2x/day for 10 weeks), which offers a daily dose of: a) Lactobacillus acidophilus NAS strain (10 billion CFU), b) Bifidobacterium bifidum Malyoth strain (40 billion CFU), and c) Lactobacillus delbrueckii subspecies bulgaricus LB-51 strain (10 billion CFU)
16193579|NCT01444859|Dietary Supplement|Placebo|Daily placebo for 10 weeks
16193580|NCT01444846|Drug|SPI-1005 Low dose|Oral capsules, 200 mg ebselen, twice daily, 4 days
16193581|NCT01444846|Drug|SPI-1005 Middle dose|Oral capsules, 400 mg ebselen, twice daily, 4 days
16193582|NCT01444846|Drug|SPI-1005 High dose|Oral capsules, 600 mg ebselen, twice daily, 4 days
16193583|NCT01444846|Drug|Placebo|Oral capsules, 0 mg ebselen, twice daily, 4 days
16193584|NCT01444833|Drug|Candesartan|32 mg per day duration 6 months
16193585|NCT01444820|Radiation|hypofractionation|Centres using IMRT will use the dose painting technique to treat the prostate + proximal 1-cm SV to 6800 cGy in 25 fractions while the pelvic lymph nodes will receive 4500 cGy in 25 fractions. For patients with T3b, the whole SV is to be treated to 6800 cGy. Institutions using 3D-CRT will deliver the required dose to the pelvic volume (including pelvic lymph nodes and boost volume) - 4500 cGy - and a concomitant boost to the prostate and proximal 1-cm (or the whole SV if involved) SV to 6800 cGy.
16193586|NCT01444820|Radiation|conventional|"The first phase: whole pelvis including the prostate and regional lymph nodes treated with 4400 cGy in 22 fractions.
~The second phase: prostate + proximal 1-cm SV treated with 3200 cGy in 16 fractions.
~For patients with T3b, the whole SV is to be treated to 7600 cGy."
16193587|NCT01444807|Drug|sorafenib|sorafenib 400 mg bid
16193588|NCT01444781|Biological|DTaP-IPV-Hep B-PRP~T combined vaccine + Pneumococcal polysaccharide|0.5 mL, Intramuscular each into the right and left deltoid muscle
16193589|NCT01444781|Biological|DTaP-Hep B-IPV // Hib Vaccine + Pneumococcal polysaccharide|0.5 mL, Intramuscular each into the right and left deltoid muscle
16193590|NCT01444781|Biological|DTaP-IPV-Hep B-PRP~T + Pneumococcal polysaccharide vaccine|0.5 mL (each), Intramuscular each into the right and left deltoid muscle
16193591|NCT01444768|Other|Computerized Physician Order Entry|Computer ordering system allowing emergency department physicians to order medications, laboratory tests, radiology studies, and nursing interventions
16193592|NCT01444742|Drug|Clofarabine|"Induction:
~10 mg/m2 by vein over 1-2 hours daily for 5 days (days 1-5)
~Consolidation:
~10 mg/m2 by vein over 1-2 hours daily for 3 days (days 1-3)"
16193593|NCT01444742|Drug|Cytarabine|"Induction:
~20 mg subcutaneously twice daily for 7 days (days 1-7)
~Consolidation:
~20 mg subcutaneously twice daily for 5 days (days 1-5)"
16193594|NCT01444729|Drug|Xiapex|Xiapex administration will follow SMPC
16193595|NCT01444729|Procedure|surgery|Non-pharmacological treatment
16193596|NCT01444716|Biological|Ofatumumab|Given IV
16193597|NCT01444703|Other|licorice solution|licorice (0.5 g)
16193598|NCT01444703|Other|sugar solution|sugar (5 g).
16193599|NCT01444690|Drug|Dimiracetam|Capsules for oral administration twice daily
16193600|NCT01444690|Drug|Dimiracetam 25 mg|Inactive dose level in capsules administered orally twice daily
16193601|NCT01444677|Drug|MB12066|MB12066 300mg
16193602|NCT01444677|Drug|MB12066|MB12066 400mg
16193603|NCT01444677|Drug|MB12066|MB12066 100mg
16193604|NCT01444677|Drug|MB12066|MB12066 200mg
16193605|NCT01444677|Drug|Placebo|Placebo 300mg (single dose), 400mg (single dose), 100mg (multiple dose), 200mg (multiple dose)
16193606|NCT01444664|Procedure|Surgical Clipping of Aneurysm|Surgical clipping of intracranial aneurysm
16193607|NCT01444651|Drug|Tadalafil|20 mg Tadalafil taken once a day for 3 months
16193608|NCT01444651|Drug|Placebo|Placebo tablet taken by mouth once a day for 3 months
16193609|NCT01444638|Device|Ultrasound examination|Trainees will receive pre-procedure U/S guided examination of the parturient's back.
16193610|NCT01444625|Other|Flavanol-rich chocolate|High-flavanol chocolate, 12 weeks.
16193611|NCT01444625|Other|Flavanol-free chocolate|Flavanol-free chocolate, 12 weeks
16193612|NCT01444612|Drug|dalteparin|An injectable anticoagulant medication for the prevention of VTE related to cancer surgery. Patients received dalteparin during one day prior to or two days after cancer-related surgery during the hospitalization.
16193613|NCT01444612|Drug|enoxaparin|An injectable anticoagulant medication for the prevention of VTE related to cancer surgery. Patients received enoxaparin during one day prior to or two days after cancer-related surgery during the hospitalization.
16193614|NCT01444612|Drug|fondaparinux|An injectable anticoagulant medication for the prevention of VTE related to cancer surgery. Patients received fondaparinux during one day prior to or two days after cancer-related surgery during the hospitalization.
16193615|NCT01444612|Drug|unfractionated heparin|An injectable anticoagulant medication for the prevention of VTE related to cancer surgery. Patients unfractionated heparin received during one day prior to or two days after cancer-related surgery during the hospitalization.
16193616|NCT01444586|Drug|Rivaroxaban (Xarelto, BAY59-7939)|The patients will be treated according to the routine practice. All the patients meeting the criteria of inclusion and exclusion to whom administration of Xarelto is indicated are fit for participation in this non-interventional study.
16193617|NCT01444573|Device|implantable continuous monitor|The Reveal XT was implanted in the parasternal area of the chest. The requirement for defining the exact final position was an R-wave amplitude ≥0.4 mV assessed through the Vector Check.
16193618|NCT01444547|Drug|paclitaxel and cisplatin|"Paclitaxel 150 mg/m2 will be administered as an intravenous (IV) infusion over 3 hour on Days 1; Cisplatin 50 mg/m2 will be administered as an intravenous (IV) infusion on Days 2, and to take enough hydration in the day and the next day.
~14 days as a cycle, up to 8 cycles."
16193619|NCT01444534|Device|Dbees; diabetes mobile phone application|Participants randomized to the intervention group (G2) were asked to stop using their paper logbook and start using an electronic logbook on their computer and mobile phone using an application of Dbees. The Dbees software enables the mobile phone to be used as a small computer to record the blood glucose values, dose of insulin injection, daily carbohydrate intake, amount of physical activity, and blood pressure.
16193620|NCT01444534|Device|control group|Participants in the control group (G1) continued using their paper logbook (usual care) and had no electronic logbook. Patients in the control group were requested not to use another mobile phone application instead of or besides their paper logbook.
16193621|NCT01444521|Drug|irinotecan and cisplatin|"irinotecan 125 mg/m2 will be administered as an intravenous (IV) infusion over half a hour on Days 1; Cisplatin 60 mg/m2 will be administered as an intravenous (IV) infusion on Days 2, and to take enough hydration in the day and the next day.
~14 days as a cycle, up to 8 cycles."
16193622|NCT01444508|Drug|"Ringer-lactate SAD"|Lactated Ringer's is administrated intravenously in the dosis of max. 35 ml/kg during the operation after securing normovolaemia with Nexfin Monitor at induction of the anaesthesia: if bolus infusion of 200 ml increases stroke volume more than 10 % the patient is not assumed normovolaemic and bolus infusions are repeated until normovolaemic status is achieved.
16193623|NCT01444508|Drug|HES 130/04|"Voluven is administered intravenously in the doses of max. 35 ml/kg during the operation. Normovolaemia is achieved in the same way as described in intervention by Ringer-lactate SAD."
16193624|NCT01444495|Radiation|Preoperative radiotherapy|Preoperative radiotherapy 5x5 Gy (total dose of 25 Gy)
16193625|NCT01444495|Procedure|Surgery|Total mesorectal excision of rectal cancer
16193626|NCT01444482|Biological|Matrix M|1 human dose of seasonal influenza vaccine formulated with 50 µg Matrix M, total dosage volume 0.55 mL injected intramuscularly in the upper arm once at day 0.
16193627|NCT01444482|Biological|Seasonal influenza vaccine|1 human dose of seasonal influenza vaccine
16193628|NCT01444469|Drug|Zithromax|250mg * 2 capsules once daily for three days
16193629|NCT01444469|Drug|Placebo|Lactose powder
16193630|NCT01444443|Device|Closed-loop control|Blood glucose controlled by algorithm
16193631|NCT01444443|Other|Open-loop control|Blood glucose controlled by patient
16193632|NCT01444430|Drug|Symbicort pMDI|Patients were randomized to Symbicort and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): Symbicort pMDI 80/4.5 μg x 2 actuations bid (morning and evening) or Symbicort pMDI 160/4.5 μg x 2 actuations bid (morning and evening), for oral inhalation.
16193633|NCT01444430|Drug|budesonide pMDI|Patients were randomized to budesonide and assigned to one of the following treatments (based upon ACQ at baseline and prior asthma therapy): budesonide pMDI 80 μg x 2 actuations bid (morning and evening) or budesonide pMDI 160 μg x 2 actuations bid (morning and evening), for oral inhalation.
16193634|NCT01444417|Drug|Romiplostim|The starting dose of romiplostim is 1 µg/kg administered weekly by subcutaneous injection. Participants will return to the clinic weekly to provide platelet counts and undergo dose titrations under the supervision of the treating physician. Weekly dose increases will continue in increments of 1 µg/kg up to a maximum dose of 10 µg/kg in an attempt to reach a target platelet count of ≥ 50 x 10^9/L. Dose adjustment will be allowed during the treatment period to maintain a platelet count between ≥ 50 x 10^9/L and ≤ 200 x 10^9/L.
16193635|NCT01444417|Drug|Placebo|Matching placebo administered by subcutaneous injection
16193636|NCT01444404|Drug|AMG 820|AMG 820 is a fully human IgG2 c-fms antagonistic antibody and will be given every two weeks until progression or unacceptable toxicity develops.
16193637|NCT01444391|Device|Tympanostomy tube placement (Acclarent iontophoresis device)|Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
16193638|NCT01444378|Device|Stenting using Absolute Pro® and Pro LL® Peripheral Stent Systems|Stenting of the Superficial Femoral Artery (SFA) and/or proximal popliteal artery using either of these devices.
16193639|NCT01444365|Drug|ABT-652 NSAID|ABT-652 capsules - 2 ABT-652 capsules twice daily (add-on) NSAID- as prescribed
16193640|NCT01444365|Drug|Placebo NSAID|Placebo - 2 placebo capsules twice daily NSAID- as prescribed
16193641|NCT01444352|Biological|Pneumococcal vaccine Formulation 1|0.5 mL, Intramuscular (Low dose)
16193642|NCT01444352|Biological|Pneumococcal vaccine Formulation 2|0.5 mL, Intramuscular (Middle dose)
16193643|NCT01444352|Biological|Pneumococcal vaccine Formulation 3|0.5 mL, Intramuscular (High dose)
16193644|NCT01444352|Biological|Placebo|0.5 mL, Intramuscular
16193645|NCT01444339|Biological|Pneumococcal Vaccine Formulation 1|0.5 mL, intramuscular (1 middle dose)
16193646|NCT01444339|Biological|Pneumococcal Vaccine Formulation 2|0.5 mL, intramuscular (2 low doses)
16193647|NCT01444339|Biological|Pneumococcal Vaccine Formulation 3|0.5 mL, intramuscular (2 middle doses)
16193648|NCT01444339|Biological|Pneumococcal Vaccine Formulation 4|0.5 mL, intramuscular (2 middle doses)
16193649|NCT01444339|Biological|Pneumococcal Vaccine Formulation 5|0.5 mL, intramuscular (2 high doses)
16193650|NCT01444339|Biological|Placebo|0.5 mL, intramuscular
16193651|NCT01444326|Other|Dairy|"During the DAIRY diet, subjects will be asked to incorporate 3 servings of dairy (375 ml of milk, 175 g of yogurt, 30 g of cheese) into their every day diet.
~During the CONTROL arm of the study, participants will be asked to consume energy equivalent replacement products (375 ml of fruit juice, 1 homemade cookie, 20 g of cashew)."
16193652|NCT01444313|Device|narafilcon A contact lens|Soft contact lenses with UV protection
16193653|NCT01444313|Device|nelfilcon A soft contact lenses|Soft contact lenses without UV protection
16193654|NCT01444300|Drug|Dalfampridine|10mg, bid, pill taken by mouth for 12 weeks
16193655|NCT01444300|Drug|Placebo|placebo pill, bid for 12 weeks
16193656|NCT01444287|Device|narafilcon B|test product
16193657|NCT01444287|Device|Polymacon|marketed product
16193658|NCT01444287|Device|Lotrafilcon A|marketed product
16193659|NCT01444287|Other|Spectacles|None - subject used own spectacles
16193660|NCT01444274|Device|Obalon Gastric Balloon(s)|One or two balloons administered per patient
16193661|NCT01444261|Dietary Supplement|Fer-in-Sol|Fer-in-Sol drops providing 7.5 mg iron in 0.3 ml per day given from 84 to 168 d of age and iron-fortified cereal
16193665|NCT01444235|Drug|Custodiol-N|Route of administration: by infusion Dosage: will be infused antegrade into the root of the aorta until 1500-2000 mL of solution have been infused Duration: infusion technique will be continued for seven minutes
16193666|NCT01444235|Drug|Custodiol|Route of administration: by infusion duration: infusion technique will be continued for seven minutes dosage: until 1500-2000 mL of solution have been infused
16193667|NCT01444209|Radiation|Iodine Implants|Interstitial Radioactive Iodine Implants
16193668|NCT01444196|Drug|Desloratadine|Every day,per mouth,in the evening, for 14 +- 2 days.
16193669|NCT01444183|Behavioral|Progressive muscle relaxation|"Subjects practice a progressive muscle relaxation exercise for 15 minutes every AM and 5 minutes every PM
~Both groups will practice twice daily, one 15 minute practice in the AM and a 5 minute practice in the PM. An additional 5 minute mid-day practice will occur only when e-diary entries from experience sampling meet specific predetermined criteria."
16193670|NCT01444183|Behavioral|Sham exercise|"The focused attention practices will consist of one or more of the following components: movement of body parts, breathing exercises, and writing exercises.
~Both groups will practice twice daily, one 15 minute practice in the AM and a 5 minute practice in the PM. An additional 5 minute mid-day practice will occur only when e-diary entries from experience sampling meet specific predetermined criteria."
16193671|NCT01444170|Dietary Supplement|dicreatinol sulfate|nutritional supplement
16193672|NCT01444170|Drug|placebo sugar pill|
16193673|NCT01444157|Other|Palliative homecare nursing|The nurse helps the family assess the identified problems. Written coping strategies according to each problem is produced including actions of the patient, family member, nurse or others. At the same time the nurse keeps attention to the family members specific needs of knowledge and support when handling direct or indirect care, understanding and coping with the disease, treatment, physical, psychosocial and economical problems and the family members own physical and mental health. The nurse provides knowledge to the family on how to prevent and/or cope with problems that may occur or re-occur and/or accepts or adapt to unsolvable problems.
16193674|NCT01444144|Other|Fracture union|Retrospective records review post-operatively until fracture resolved.
16193675|NCT01444131|Drug|Varenicline, Nicotine Patch|active nicotine patches added to varenicline.
16193676|NCT01444131|Drug|Varenicline and Placebo Patch|placebo nicotine patches added to varenicline.
16193677|NCT01444118|Biological|Therapeutic EGF Vaccine (Cyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51 vaccine)|Patients in this arm will receive a low dose of Cyclophosphamide and the recombinant human rEGF-P64K/Montanide ISA 51 vaccine in addition to Best Supportive Care.
16193678|NCT01444105|Device|iStent|Implantation of two iStent devices
16193679|NCT01444105|Other|SLT|Laser treatment
16193680|NCT01444092|Drug|Entocort|Entocort capsules, oral
16193681|NCT01444066|Procedure|Dilation of the esophagus|Esophagus will be dilated with a Savory dilator.
16193682|NCT01444053|Device|No Intervention|No Intervention
16193683|NCT01444040|Device|iStent inject|Implantation of two iStent inject devices
16193684|NCT01444040|Drug|Travoprost|Travoprost drops
16193685|NCT01444027|Behavioral|Problem Solving Therapy|Problem-solving therapy (PST) focuses on behavioral change principles derived from this theoretical framework. PST addresses four skills: 1) problem definition and formulation, which involves gathering data and information, articulating the issue in clear terms, identifying the challenge, and setting realistic goals; 2) generation of alternative strategies; 3) decision making; and 4) solution implementation. The intervention is delivered in a series of interactions with the interventionist.
16193686|NCT01444014|Drug|YF476|50 mg once daily for 12 weeks, with the option to increase to 75 mg or 100 mg once daily after 6 weeks, or decrease to 25 mg once daily, depending on response.
16193687|NCT01444001|Biological|Pneumococcal Vaccine|0.5 mL, intramuscular
16193688|NCT01444001|Biological|Pneumococcal Vaccine|0.5 mL, intramuscular
16193689|NCT01444001|Biological|Pneumococcal Vaccine|0.5 mL, intramuscular
16193690|NCT01443988|Device|iStent|Implantation of two iStent devices
16193691|NCT01443988|Drug|Travoprost|Travoprost drops
16193692|NCT01443975|Procedure|x-pander|Measurement of the size and quality of the bony acetabulum before mounting the artificial hip socket.
16193693|NCT01443962|Other|PEEP|applying PEEP 0 cmH2O during pneumoperitoneum continuously
16193694|NCT01443962|Other|ZEEP|applying PEEP 10 cmH2O during pneumoperitoneum continuously
16193695|NCT01443936|Biological|Ad4-H5-VTN vaccination-tonsillar route|
16193696|NCT01443936|Biological|Ad4-H5-vaccination-oral route|
16193697|NCT01443923|Drug|Boceprevir|
16193698|NCT01443923|Drug|Peg-Interferon-alfa 2B|
16193699|NCT01443923|Drug|Ribavirin|
16193700|NCT01443897|Dietary Supplement|1,000 IU vitamin D2|capsule containing 1,000 IU vitamin D2
16193701|NCT01443897|Dietary Supplement|placebo capsule|0 IU vitamin D2
16193702|NCT01443897|Other|mushrooms|untreated button mushrooms, obtained from Monterey Mushrooms, Monterey, CA
16193703|NCT01443897|Other|UVB-treated mushrooms, 400 IU vitamin D2|UVB-treated button mushrooms, 400 IU vitamin D2 per 1/2 cup serving, obtained from Monterey Mushrooms, Monterey, CA
16193704|NCT01443897|Other|UVB-treated mushrooms, 1,000 IU vitamin D2|UVB-treated button mushrooms, 1,000 IU vitamin D2 per 1/c serving, obtained from Monterey Mushrooms, Monterey, CA
16193705|NCT01443884|Dietary Supplement|Grape powder, followed by placebo powder|For three weeks, twice per day, volunteers will consume one packet of freeze-dried grape powder containing the equivalent of approximately 2 servings of fresh grapes (46 grams of powder) stirred into water. Following a two week washout, volunteers will consume one packet of placebo powder twice per day for three weeks.
16193706|NCT01443884|Dietary Supplement|Placebo powder followed by grape powder|For three weeks, twice per day, volunteers will consume one packet of placebo powder stirred into water. Following a two week washout, volunteers will consume one packet of freeze-dried grape powder containing the equivalent of approximately 2 servings of fresh grapes (46 grams of powder) twice per day for three weeks.
16193707|NCT01443871|Other|Aromatherapy|Subject will assigned inhale aromatherapy
16193708|NCT01443871|Other|Pure water|Subject will assigned inhale Pure water
16193748|NCT01443520|Drug|Venlafaxine|The subjects will be given orally venlafaxine 37,5mg twice a day for 8 days prior to the study.
16193709|NCT01443858|Drug|Meclizine|Pre-Quit Period: In this group, participants will take meclizine daily during the three week pre-quit period. The meclizine will be taken in two doses daily, one capsule with breakfast and one with dinner.
16193710|NCT01443858|Drug|Nicotine Patch|"Pre-Quit Period: During weeks two and three, participants will apply active 21mg/24h nicotine patches daily.
~Post-Quit Period: Following the quit-day these participants will apply active nicotine patches daily using the following dose schedule: 21mg/24h for four weeks, 14mg/24h for one week, and 7mg/24h for one week."
16193711|NCT01443858|Drug|Placebo|Pre-Quit Period: In this group, participants will take placebo capsules daily during the three week pre-quit period. The placebo will be taken in two doses daily, one capsule with breakfast and one with dinner.
16193712|NCT01443845|Drug|Roflumilast|Roflumilast 500 µg, oral administration, once per day
16193713|NCT01443845|Drug|Placebo|Dose-matched placebo, oral administration, once per day.
16193714|NCT01443832|Dietary Supplement|Fe57 and Fe58-FeSO4 stable isotopes|[57Fe] and [58Fe]- FeSO4 prepared from isotopically enriched 57Fe and 58Fe respectively, by dilution of each compound in 0.1 mol H2SO4/L.
16193715|NCT01443819|Other|Lumbar Transforaminal Epidural Corticosteroid Injection|"Injection: Anesthetic/corticosteroid (per randomization); repeat 1-3 times if clinically indicated.
~The following drugs will be used for this procedure: 80mg Depo-Medrol and 1% lidocaine. These drugs used for the epidural injections are local anesthetic numbing medicines and cortisone/steroid anti-inflammatory medicines."
16193716|NCT01443819|Other|Physical Therapy|"Physical therapy carried out per protocol; 2-3 times per week for a total of 12 treatment sessions (excluding initial evaluation, including exit evaluation, minimum attendance 8/12) to be completed by 6 weeks from initiation of care (within study).
~Please note: There will be another PT evaluation at the end of 6 weeks."
16193717|NCT01443819|Other|Observation|If subject declines then inquire about enrolment in the observational cohort. Participants in this group (Cohort) will chose their treatment (per-protocol physical therapy, injections, or both) after consulting with their physicians.
16193718|NCT01443806|Drug|Oseltamivir|75 mg, one time
16193719|NCT01443780|Dietary Supplement|Selenium and ubiquinon (Q10) combined|A combination of 200 mg/day of coenzyme Q10 (Bio-Quinon 100 mg B.I.D, Pharma Nord, Vejle, Denmark) and 200 µg/day of organic selenium (SelenoPrecise 200 µg, Pharma Nord), or placebo
16193720|NCT01443754|Procedure|LIMA-LAD surgical revascularization|"Off-pump coronary artery bypass (OPCAB) in which coronary revascularization is performed on the beating heart will be followed, the choice of the technical solutions being left at the discretion of the cardiac surgeon:
~use of a left anterior small thoracotomy (LAST), LIMA harvesting using thoracoscopic methods and manual anastomosis of the LIMA-LAD using a stabilization device;
~minimally invasive direct coronary bypass surgery (MIDCAB). The procedures can be performed alone or in combination with one another."
16193721|NCT01443754|Procedure|PCI|"State of the art drug eluting stent (DES)-based percutaneous coronary intervention will be used by each participating site, according to current international guidelines.
~Zotarolimus, everolimus or sirolimus drug-eluting stents will be used in all sites."
16193722|NCT01443741|Other|Therapeutic education|Specific program for FIT Therapy and specific program for traditional way
16193723|NCT01443728|Drug|Experimental: Vitamin D3 100,000 IU|Oral vitamin D3, 100,000 IU [2.5 mg] given once a month
16193724|NCT01443728|Drug|Active Comparator: Vitamin D3 12,000 IU|Standard dose oral vitamin D3 12,000 IU [0.3 mg] given once a month
16193725|NCT01443715|Behavioral|Stepped Care IPT-A (SCIPT-A)|Interpersonal Psychotherapy for adolescents (IPT-A) is a guideline based treatment with established efficacy focusing on reducing depression symptoms and current interpersonal problems associated with depression.
16193726|NCT01443715|Behavioral|Treatment as Usual|Standard treatment in the community
16193727|NCT01443702|Drug|Lapis Judaicus|2 g capsule per day.
16193728|NCT01443702|Drug|Placebo|2 g capsule per day.
16193729|NCT01443689|Biological|human umbilical cord mesenchymal stem cells|Participants will be given conventional therapy plus hUCMSCs transplantation.
16193730|NCT01443689|Biological|human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells|Participants will be given conventional therapy plus and hCBMNCs and hUCMSCs transplantation.
16193731|NCT01443689|Drug|Conventional therapy|Participants will be given conventional therapy only.
16193732|NCT01443676|Drug|Bevacizumab|Bevacizumab will be added to radiotherapy
16193733|NCT01443676|Radiation|Radiation therapy|Radiation therapy
16193734|NCT01443663|Biological|H5N1 Vaccine|Vaccine will be administered intramuscularly (IM) in the deltoid muscle at baseline for participants in Groups 1-4 and at baseline and Day 28 for participants in Group 5.
16193735|NCT01443650|Drug|alirocumab SAR236553 (REGN727)|Pharmaceutical form:solution Route of administration: subcutaneous
16193736|NCT01443624|Drug|critical care patients venofer|100mg IV in one hour (in critically ill patients the injection could be repeated on day 2 (200mg) and 4 (100mg) depending on treatment
16193737|NCT01443585|Device|Progressive Addition Lens (Shamir PrimeIITM) Spectacles|A pair of progressive addition lenses manufactured according to the subject's personal prescription.
16193738|NCT01443572|Drug|desflurane anesthetics|40 patients are randomly allocated into two groups : desflurane group (n=20) and sevoflurane group (n=20). And anesthesia is maintained with desflurane (desflurane group) or sevoflurane (sevoflurane group).
16193739|NCT01443572|Drug|sevoflurane anesthetics|40 patients are randomly allocated into two groups : desflurane group (n=20) and sevoflurane group (n=20). And anesthesia is maintained with desflurane (desflurane group) or sevoflurane (sevoflurane group).
16193740|NCT01443559|Genetic|Xenogenic cornea|lamellar acellular xenogenic corneas were sterilised by radiation
16193741|NCT01443559|Genetic|homogenic cornea|homogenic corneas were sterilised by radiation
16193742|NCT01443546|Drug|HCG|hCG Trigger
16193743|NCT01443546|Drug|Lupron Trigger|leuprolide acetate 2 mg SQ
16193744|NCT01443546|Drug|Dual Trigger|a combination of the two drugs in low dosage (leuprolide acetate 2 mg and hCG 1500 IU).
16193745|NCT01443533|Behavioral|LARC Script|The LARC Script is a one-minute educational script that describes long-acting reversible contraceptive methods.
16193746|NCT01443520|Drug|Placebo|The subjects will be given orally placebo twice a day for 8 days prior to the study.
16193747|NCT01443520|Drug|Duloxetine|The subjects will be given orally duloxetine 30mg twice a day for 8 days prior to the study.
16193749|NCT01443507|Other|endurance exercise of different duration and intensity|Two interventions are compared with aerobic capacity as the main outcome. one group exercise at 70% of maximal heart rate for 90 minutes 3 times per week. group two exercise performe10 minutes warm up at 70% of maximal heart rate 4 x 4 minutes intervals at 90-95% of maximal heart rate with 3 minutes active pause at 70% of maximal heart rate in between, and finally 5 minutes cooling down at 70 % of maximal heart rate.
16193750|NCT01443494|Other|NE|norepinephine
16193751|NCT01443481|Drug|Dovitinib|Starting dose to be determined based on the study outcome of the mild and moderate hepatic impairment groups
16193752|NCT01443455|Behavioral|videodance|Using a commercially available product called Dance Dance Revolution (DDR) this video-game based dancing system uses a game player, force sensing pad and software. The step sequences are set to a wide range of music and become more complex and frequent as the dancer gains skill. Participants are oriented over 2 weeks. For the rest of the first 3 months, the participant attends at least one supervised session per week. Participants may use the center for additional, unsupervised sessions and/or they can take a dance system home. They also receive brief behavioral intervention sessions for safety orientation, exercise education and adherence promotion. For the following 3 months, the participant enters the transition phase in which she is encouraged to continue to exercise but no formal supervision is provided.
16193753|NCT01443455|Behavioral|Brisk Walking|The overall goal is to increase the duration and speed of walking, using structure and supervision for the first three months, followed by reduced support in the second three months. For the first two weeks, each participant comes to the center at least twice a week to walk.They are encouraged to gradually increase effort and duration to a target of 150 minutes per week of brisk walking.Participants are taught to use Borg's ratings of perceived exertion and self-monitored heart rate to target their level of activity. The next 10 weeks include once weekly supervised sessions and additional sessions either at the center or in preferred community settings. The recommended goal is a minimum of 150 minutes per week of exercise in sessions of at least 10 -15 minutes duration.Participants are given pedometers in order to help them monitor their progress. After 12 weeks, the participant enters a transition phase for a further 3 months.
16193754|NCT01443455|Behavioral|delayed entry control|"Participants who are randomized to the delayed entry non-exercise control group receive the American Heart Association pamphlet, but no direct support for exercise implementation. After they have completed six months of follow up, they are invited to select any combination of dancing and walking that they prefer and then receive support and instruction according to the protocols described above.
~--------------------------------------------------------------------------------"
16193755|NCT01443442|Drug|bepotastine besilate, 1.5%|Topical ocular aqueous formulation, oen drop per instillation, twice per day for 14 days
16193756|NCT01443442|Drug|Loteprednol etabonate|Topical ocular aqueous formulation, one drop per instillation, four times per day for 14 days
16193757|NCT01443429|Drug|beraprost sodium(BPS)|
16193758|NCT01443416|Biological|13-valent pneumococcal conjugate vaccine|The vaccine will be given to 12 month old children who have had 2 doses of Prevenar at 2 and 4 months of age
16193759|NCT01443416|Biological|10-valent pneumococcal conjugate vaccine|The vaccine will be given to 12 month old children who have had 2 doses of Prevenar at 2 and 4 months of age.
16193760|NCT01443403|Drug|Placebo|Matching placebo tablets administered orally once a day.
16193761|NCT01443403|Drug|Naldemedine|Naldemedine tablets administered orally once a day.
16193762|NCT01443377|Biological|Panitumumab|Intravenous (IV), Panitumumab 6 mg/kg BW q2w d1-d57 (5 times total); begin on day 1 (run-in-phase) and subsequent application on days 15, 29 43 and 57.
16193763|NCT01443364|Biological|Certolizumab pegol|Prefilled syringes containing an injectable volume of 1ml of liquid Certolizumab Pegol (CZP) for single use at a dosage strength of 200 mg/ml. Injections will be given subcutaneously. CZP 400 mg at Week 0, 2 and 4, then continued as maintenance dose of 200 mg every 2 weeks until Week 50.
16193764|NCT01443338|Drug|Triptergium Wilfordii|Tablet,10mg/Tab,20mg Tid,No more than 8 Weeks
16193765|NCT01443338|Drug|Acitretin|Capsule,10mg/Cap,30mg Qd,no more than 8 weeks
16193766|NCT01443325|Drug|lidocaine patch|1 patch for 12 hours within each 24 hours period
16193767|NCT01443312|Genetic|Laboratory analysis.|The blood transfusions given to the patients are in accord to physician decision and not related to the study
16193768|NCT01443273|Other|Medical Records study|No interventions will be done related to the study besides summary of the Medical Files.
16193769|NCT01443260|Biological|GL-ONC1|A genetically-engineered vaccinia virus administered via intraperitoneal infusion through an indwelling catheter every 4 weeks for 4 cycles.
16193770|NCT01443247|Drug|anti-d|intervention group received injection anti-d in dose of 50 µg/kg (250IU/kg) along with platelet concentrate while control ( non intervention ) group received platelet support only
16193771|NCT01443234|Other|OxIGen|Internet-based intervention with 12 sessions over 4 weeks
16193772|NCT01443234|Other|OxIGen: control version|A control version of the OxIGen internet-based intervention (i.e. identical but with putative active components removed)
16193773|NCT01443221|Drug|mitiglinide and metformin|Free combination of Mitiglinide 10mg and Metformin 500mg
16193774|NCT01443221|Drug|mitiglinide and metformin|Fixed-dose combination of Mitiglinide 10mg and Metformin 500mg
16193775|NCT01443208|Drug|desvenlafaxine|one 50 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days
16193776|NCT01443208|Drug|desvenlafaxine|one 100 mg desvenlafaxine succinate sustained-release tablet or matching placebo, single dose and once daily dose for 5 days
16193777|NCT01443208|Drug|desvenlafaxine|two 100 mg desvenlafaxine succinate sustained-release tablets or matching placebo, single dose and once daily dose for 5 days
16193778|NCT01443195|Drug|Iron preparation|"Iron supplementation with IPC in a dose of 4 mg/kg/day of elemental iron started not before 4 weeks of age and as soon as 120 ml/kg/day of enteral feedings is tolerated given together with the first morning meal. Serum samples will be obtained at 3 different times:
~Before starting iron supplementation (maximum one week before).
~At the beginning of iron supplementation in order to assess early signs of erythropoiesis, iron overload or free iron (day 4 - 7 days of supplementation).
~Before discharge from hospitalization in order to asses the iron metabolism and sings of iron deficiency (At least more than 2 weeks of supplementation)."
16193779|NCT01443182|Behavioral|STAIR|Skills Training in Affective and Interpersonal Regulation
16193781|NCT01443182|Behavioral|EMDR|Eye movement desensitization and reprocessing
16193782|NCT01443169|Drug|Sequence 1 - Treatment A: Controlled Release Pregabalin|330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.
16193783|NCT01443169|Drug|Sequence 1 - Treatment B: Controlled Release Pregabalin|330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
16193784|NCT01443169|Drug|Sequence 1 - Treatment C:Controlled Release Pregabalin|330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
16193785|NCT01443169|Drug|Sequence 1 - Treatment D: Controlled Release Pregabalin|330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.
16193786|NCT01443169|Drug|Sequence 1 - Treatment E: Immediate Release Pregabalin|300 mg IR capsule administered in the evening in the fasted state.
16193787|NCT01443169|Drug|Sequence 2 - Treatment B: Controlled Release Pregabalin|330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
16193788|NCT01443169|Drug|Sequence 2 - Treatment D: Controlled Release Pregabalin|330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.
16193789|NCT01443169|Drug|Sequence 2 - Treatment A: Controlled Release Pregabalin|330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.
16193790|NCT01443169|Drug|Sequence 2 - Treatment C: Controlled Release Pregabalin|330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
16193791|NCT01443169|Drug|Sequence 2 - Treatment E: Immediate Release Pregabalin|300 mg IR capsule administered in the evening in the fasted state.
16193792|NCT01443169|Drug|Sequence 3 - Treatment C: Controlled Release Pregabalin|330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
16193793|NCT01443169|Drug|Sequence 3 - Treatment A: Controlled Release Pregabalin|330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.
16193794|NCT01443169|Drug|Sequence 3 - Treatment D: Controlled Release Pregabalin|330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.
16193795|NCT01443169|Drug|Sequence 3 - Treatment B: Controlled Release Pregabalin|330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
16193796|NCT01443169|Drug|Sequence 3 - Treatment E: Immediate Release Pregabalin|300 mg IR capsule administered in the evening in the fasted state.
16193797|NCT01443169|Drug|Sequence 4 - Treatment D: Controlled Release Pregabalin|330 mg CR reference tablet administered after a 600 to 750 calorie medium-fat evening meal.
16193798|NCT01443169|Drug|Sequence 4 - Treatment C: Controlled Release Pregabalin|330 mg CR tablet (slow dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
16193799|NCT01443169|Drug|Sequence 4 - Treatment B: Controlled Release Pregabalin|330 mg CR tablet (fast dissolution, lighter tablet) administered after a 600 to 750 calorie medium-fat evening meal.
16193800|NCT01443169|Drug|Sequence 4 - Treatment A: Controlled Release Pregabalin|330 mg CR tablet (fast dissolution, heavier tablet) administered after a 600 to 750 calorie medium-fat evening meal.
16193801|NCT01443169|Drug|Sequence 4 - Treatment E: Immediate Release Pregabalin|300 mg IR capsule administered in the evening in the fasted state.
16193802|NCT01443143|Other|Portion-controlled diet|During this diet period, participants will consume portion-controlled products from the Nutrisystem-D program for three entrees and one (women) or two (men) snacks per day. These pre-packaged portion-controlled items will be supplemented with grocery additions (fruits, vegetables, and low-fat dairy items) to provide approximately 1300 (women) to 1500 (men) calories per day. The Nutrisystem-D program (i.e., provided foods plus grocery additions) provides approximately 53% of calories from carbohydrate, 22% of calories from fat (6% from saturated fat and 0% from trans fat), and 25% of calories from protein. Women and men on the program consume approximately 1800 and 2000 mg/d, respectively, of sodium, and 31 and 35 g/d, respectively, of fiber.
16193803|NCT01443143|Dietary Supplement|Usual Diet|"During the usual diet period, participants will not be given any specific instructions about what they should or should not consume. Instead, they will be told to Eat how you would normally eat if you were not in this study."
16193804|NCT01443130|Drug|Chloroquine|Chloroquine tablets contain 300 mg chloroquine base per tablet. Dosages: Chloroquine 1,500 mg base over 3 days twice during pregnancy or Chloroquine 600 mg loading dose followed by 300 mg orally once per week. Intermittant preventative treatment in pregnancy (IPTp) doses will be administered between weeks 20-28 and weeks 28-34 gestation, 4 weeks apart. Participants randomized to IPTp with chloroquine will require their second and third doses of chloroquine after the initial dose given in the clinic and those assigned to chloroquine chemoprophylaxis will require weekly doses.
16193805|NCT01443130|Drug|Sulfadoxine-pyrimethamine|Sulfadoxine-pyrimethamine 3 tablets (1,500 mg sulfadoxine and 75 mg pyrimethamine) twice during pregnancy. Intermittant preventive treatment in pregnancy (IPTp) doses will be administered between weeks 20-28 and weeks 28-34, 4 weeks apart.
16193806|NCT01443117|Biological|PPV-23 Vaccine|Administered as a 0.5 mL IM dose
16193807|NCT01443117|Biological|PCV-13 Vaccine|Administered as a 0.5 mL IM dose
16193808|NCT01443117|Biological|Placebo Vaccine|Administered as a 0.5 mL IM dose
16193809|NCT01443104|Device|Sirolimus-eluting stent with a bioresorbable polymer (Orsiro)|Percutaneous coronary intervention with implantation of a sirolimus-eluting stent with a bioresorbable polymer for coronary artery disease
16193810|NCT01443104|Device|Everolimus-eluting stent with a durable polymer|Percutaneous coronary intervention with implantation of an everolimus-eluting stent with a durable polymer for coronary artery disease
16193811|NCT01443091|Other|application of mother's own colostrum|application of 0.2mL of mother's own colostrum to the infant's oropharyngeal mucosa every 3 hours for 5 days (day of life 2 until day of life 7)
16193812|NCT01443091|Other|application of sterile water|application of 0.2mL sterile water to the infant's oropharyngeal mucosa every 3 hours for 5 days (from day of life 2 until day of life 7)
16193813|NCT01443078|Drug|pemetrexed|
16193814|NCT01443078|Drug|cisplatin|
16193815|NCT01443078|Drug|Carboplatin|
16193816|NCT01443078|Drug|Gemcitabine Hydrochloride|
16193817|NCT01443078|Drug|Vinorelbine Tartrate|
16193818|NCT01443078|Drug|Docetaxel|
16193819|NCT01443065|Drug|Oxaliplatin|85mg/m² over 120 mn every 2 weeks up to progression or toxicity
16193820|NCT01443065|Drug|Folinic Acid|400mg/m² over 120 mn every 2 weeks up to progression or toxicity
16193821|NCT01443065|Drug|5-fluoro-uracil|400mg/m² in bolus, then 2400mg/m² over 46 h every 2 weeks up to progression or toxicity
16193822|NCT01443065|Drug|panitumumab|6mg/kg over 60-90 mn every 2 weeks up to progression or toxicity
16193823|NCT01443065|Drug|AMG102|10mg/kg over 60 mn every 2 weeks up to progression or toxicity
16193824|NCT01443052|Other|Gait analysis|walking on an electronic walkway GAITRite® at self-selected speed
16193825|NCT01443039|Drug|phenotypical approach|each visit : CAFEINE : (solution orale) 2 ampoules de 2 ml = 100 mg de CAFEINE DEXTROMETHORPHANE : 15 ml de sirop contains 20 mg =>22,5 ml = 30mg Midazolam : (solution injectable, ampoule 1 ml = 1 mg) : deux ampoules = 2 mg Digoxine nativelle (solution injectable, ampoule de 0.5mg) : 1 ampoule per os = 0.5 mg Losartan 50 mg : 1cp de 50mg
16193826|NCT01443026|Drug|Lycopene 30mg|Lycopene 30 mg.
16193827|NCT01443026|Drug|Placebo|Placebo
16193828|NCT01443013|Other|Renal Transplant|urinary sample at month 3, 6 and 12
16193829|NCT01442987|Drug|Irbesartan/Atorvastatin A|once daily, P.O. 8week
16193830|NCT01442987|Drug|Irbesartan|once daily, P.O. 8week
16193831|NCT01442987|Drug|Atorvastatin A|once daily, P.O. 8week
16193832|NCT01442987|Drug|Placebo|once daily, P.O. 8week
16193833|NCT01442987|Drug|Irbesartan/Atorvastatin B|once daily, P.O. 8week
16193834|NCT01442987|Drug|Atorvastatin B|once daily, P.O. 8week
16193835|NCT01442974|Drug|Gemcitabine plus nab-paclitaxel|Gemcitabine 1000mg/mq on d1,8,15 over 28 days of cycle nab-paclitaxel 125mg/mq on d1,8,15 over 28 days cycle Treatment will be administered for two cycles
16193836|NCT01442961|Procedure|laparoscopy, laparoscopic hysterectomy|laparoscopic hysterectomy
16193837|NCT01442961|Procedure|vaginal : vaginal hysterectomy|Vaginal hysterectomy
16193838|NCT01442935|Drug|Oxaliplatin|85mg/m² over 120 mn every 2 weeks up to progression or toxicity
16193839|NCT01442935|Drug|Folinic Acid|400mg/m² over 120 mn every 2 weeks up to progression or toxicity
16193840|NCT01442935|Drug|5-FU|400mg/m² in bolus, then 2400mg/m² over 46 h every 2 weeks up to progression or toxicity
16193841|NCT01442935|Drug|Irinotecan|180mg/m² over 90 mn every 2 weeks up to progression or toxicity
16193842|NCT01442935|Drug|Irinotecan|150mg/m² over 30-90 mn every 2 weeks up to progression or toxicity
16193843|NCT01442935|Drug|Bevacizumab|5mg/kg over 90 mn every 2 weeks up to progression or toxicity
16193844|NCT01442935|Drug|Cetuximab|500mg/m² over 90 mn every 2 weeks up to progression or toxicity
16193845|NCT01442922|Other|completion of the (VAS) for level of back pain|Patients will complete the (VAS) pre-operatively and post-operatively at 6 wks, and 3, 6, 12, and 24 mos.
16193846|NCT01442922|Other|completion of the (OLBPQ) for assessment of function|Patients will complete the (OLBPQ) pre-operatively and post-operatively at 6 wks, and 3, 6, 12, and 24 mos.
16193847|NCT01442909|Drug|Docetaxel and pemetrexed|docetaxel 60mg/m2 every 3 weeks for 4 cycles followed by pemetrexed 500mg/m2 every 3 weeks for 4 cycles; or in reverse sequence.
16193848|NCT01442883|Device|Simplicity Catheter|percutaneous selective renal sympathetic nerve ablation with the use of the Simplicity Catheter system
16193849|NCT01442870|Drug|Metformin|Metformin
16193850|NCT01442857|Radiation|MRI|High resolution MRI of the brachial plexus
16193851|NCT01442844|Device|Micrografting|Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile dressing that will be placed on the surgical wound.
16193852|NCT01442831|Drug|Human ADME|Oral single dose
16193853|NCT01442818|Drug|Dilaudid PCA|PCA setting of 0.3mg demand dose, 8 minute lock out interval, and 5mg 4-hour limit.
16193854|NCT01442818|Drug|Dilaudid IV Scheduled|Nurse administered IV Dilaudid 0.5mg every 2 hours.
16193855|NCT01442805|Behavioral|Virtual Reality Exposure Therapy|Participants are exposed to the feared situation (flying) through the virtual reality technology
16193856|NCT01442805|Behavioral|Exposure Therapy through Imagination|Participants are exposed to the feared situation (flying) through exposure technique of imagination.
16193857|NCT01442792|Drug|UFH|Unfractionated Heparin: 70-100 IU/Kg bolus and adjusted upon activated coagulation time (ACT) 250 300 seconds
16193858|NCT01442792|Drug|Rivaroxaban (Xarelto, BAY59-7939)|10 mg single dose Rivaroxaban (per os)
16193859|NCT01442792|Drug|Rivaroxaban (Xarelto, BAY59-7939)|20 mg single dose Rivaroxaban (per os)
16193860|NCT01442792|Drug|Rivaroxaban (Xarelto, BAY59-7939) and UFH|10 mg single dose Rivaroxaban (per os) followed by bolus 50 IU/Kg unfractionated heparin (UFH)
16193861|NCT01442779|Drug|Interferon alpha oral lozenge|dose form - oral lozenge dose - 150 International Units (IU) frequency - 3 times a day duration - at least 1 year
16193862|NCT01442766|Drug|Donepezil|5mg for 4 weeks, 10mg for 8 weeks if tolerated, or lower dose to continue
16193863|NCT01442766|Drug|Placebo|Inert pill that appears identical to donepezil pill. 1 pill for first 4 weeks, followed by 2 pills until end of study.
16193864|NCT01442753|Behavioral|Family-Skills Training|Sessions will be divided between self-reflection, didactics, and skill-building exercises all aimed at developing strong parenting practices and facilitating relationship building between parents and youth.
16193865|NCT01442740|Procedure|Reverse Trendelenburg Position|Patients will be placed on the operating table in a head up, feet down, tilt position (15 degree tilt to the horizontal). This is in contrast to the standard of care, 0-degree supine position.
16193866|NCT01442727|Drug|sodium selenite|200 micrograms (µg) of selenium in the form of sodium selenite; capsule form consumed once daily with breakfast.
16193867|NCT01442727|Drug|placebo|dicalcium phosphate capsule matching the selenium capsule in appearance; consumed once daily with breakfast
16193868|NCT01442714|Drug|Azacitidine|Azacitidine is a chemical analogue of the cytosine nucleoside used in DNA and RNA. Azacitidine is thought to induce antineoplastic activity via two mechanisms; inhibition of DNA methyltransferase at low doses, causing hypomethylation of DNA, and direct cytotoxicity in abnormal hematopoietic cells in the bone marrow through its incorporation into DNA and RNA at high doses, resulting in cell death
16194166|NCT01440582|Behavioral|Symptom Questionnaire|Completed on day 1 of each cycle.
16193869|NCT01442714|Drug|Lenalidomide|Lenalidomide has been used to successfully treat both inflammatory disorders and cancers. In vitro, lenalidomide has three main activities: direct anti-tumor effect, inhibition of angiogenesis, and immunomodulatory role. In vivo, lenalidomide induces tumor cell apoptosis directly and indirectly by inhibition of bone marrow stromal cell support, by anti-angiogenic and anti-osteoclastogenic effects, and by immunomodulatory activity.
16193870|NCT01442701|Other|Removal of triclosan-containing cleaning products from household.|An intervention is nested within the observational cohort study as a secondary outcome. Commercially available household and personal cleaning products that either do not contain triclosan or that may contain triclosan will be delivered to the household every 4 months for the duration of the study. All cleaning products will be formulated, packaged and labeled by the original manufacturer with no modification for this study. Use of these products will be as per each individual product's label and at the discretion of the participant.
16193871|NCT01442688|Drug|Amoxicillin + MMX placebo|MMX placebo administered once a day (QD) orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX placebo on Day 4.
16193872|NCT01442688|Drug|Amoxicillin + MMX mesalazine/mesalamine|MMX mesalazine/mesalamine (4.8 g) administered QD orally on Days 1-3, then a single oral dose of Amoxicillin (500 mg) + MMX mesalazine/mesalamine (4.8 g) on Day 4.
16193873|NCT01442675|Biological|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra®|0.5 mL, Intramuscular
16193874|NCT01442662|Drug|pazopanib + gemcitabine|pazopanib tablets (200mg) per os, 800mg/day continuously gemcitabine IV, 2 injection per cycle
16193875|NCT01442649|Drug|Oxaliplatin|85mg/m² over 120 mn on D1 every 2 weeks up to progression or toxicity
16193876|NCT01442649|Drug|Folinic Acid|400 mg/m² (racemic) (or 200 mg/m² if L-folinic acid) over 2 h IV on D1 (in the same time that oxaliplatin or irinotecan) every 2 weeks up to progression or toxicity
16193877|NCT01442649|Drug|5-fluoro-uracil|400mg/m² in bolus on D1, then 2400mg/m² over 46 h every 2 weeks up to progression or toxicity
16193878|NCT01442649|Drug|Irinotecan|180 mg/m2 over 90 mn IV on D1 every 2 weeks up to progression or toxicity
16193879|NCT01442649|Drug|Bevacizumab|5 mg/kg IV over 90 mn on D1 every 2 weeks up to progression or toxicity
16193880|NCT01442649|Drug|Cetuximab|500mg/m² on D1 every 2 weeks up to progression or toxicity
16193881|NCT01442636|Device|stent|Implantation of one or more Everolimus-eluting XIENCE PRIME™ Everolimus Eluting Coronary Stent Systems.
16193882|NCT01442623|Other|Vestibular Rehabilitation|"The patients in the Nintendo Wii Vestibular Rehabilitation group will undergo a standardised 6 week program of vestibular rehabilitation using the Nintendo Wii Fit Plus at home 5 times a week. They will perform a series of exercises and games on the Wii Fit Plus that are designed to challenge and retrain balance. They will be seen once a week by a physiotherapist for review and progression of exercises.
~Patients in the Conventional Vestibular Rehabilitation group will undergo a standardised program of conventional vestibular rehabilitation using conventional balance exercises (Herdman 2007) 5 times a week. They will be seen once a week by a physiotherapist to progress exercises and will receive a standardised home exercise program."
16193883|NCT01442610|Drug|Rasagiline|Rasagiline tablets 1mg once daily for 8 weeks
16193884|NCT01442610|Drug|Placebo|Placebo 1tablet once daily for 8 weeks
16193885|NCT01442597|Behavioral|Standard Treatment As Usual (TAU)|Treatment normally offered at this clinic which could include individual or group drug counseling sessions one time per week last one hour each time.
16193886|NCT01442597|Behavioral|Individual clinician-provided CBT|Individual drug counseling sessions with trained clinicians using CBT one time per week last one hour per session.
16193887|NCT01442597|Behavioral|CBT4CBT|Subjects work with a computerized program that teaches skills for stopping drug use and increasing coping skills. Computerized sessions are one time per week and last about one hour per session.
16193888|NCT01442584|Procedure|ovarian transplantation|ovarian transplantation
16193889|NCT01442571|Device|Hyaluronic Acid Injection|
16193890|NCT01442571|Drug|Saline Injection|
16193891|NCT01442558|Drug|Bupivacaine|Bupivacaine 5 mg/cc with adrenaline 5 mcg/cc will be injected with complete spread of the drug around nerves.
16193892|NCT01442545|Drug|JNJ-39758979 / MTX|Day 1: MTX: Route=oral use, single dose of participant's weekly MTX dose; Days 3-15: MTX: Route=oral use, single dose of participant's weekly MTX dose and JNJ 39758979: Type=exact, unit=mg, number=300, form=tablet, route=oral use, administered daily.
16193893|NCT01442532|Drug|JNJ-38518168 (30 mg)|Type=range, unit=mg, number=30, form=tablet, route=oral use, in single and multiple doses for 14 days
16193894|NCT01442532|Drug|JNJ-38518168 (10 mg)|Type=range, unit=mg, number=10, form=tablet, route=oral use, in single and multiple doses for 14 days
16193895|NCT01442532|Drug|JNJ-38518168 (3 mg)|Type=range, unit=mg, number=3, form=tablet, route=oral use, in single and multiple doses for 14 days
16193896|NCT01442532|Drug|Placebo|Form=tablet, route=oral use, for 14 days
16193897|NCT01442532|Drug|Midazolam and JNJ-38518168|Midazolam: Type=exact, unit=mg, number=2.5, form=oral solution; route=oral use, on Days 1 and 15; JNJ-38518168: Type=exact, unit=mg, number=30, form=tablet, route=oral use, once daily from Day 2 through Day 15
16193898|NCT01442519|Biological|bacillus Calmette-Guerin|The BCG instillation consisted of 81 mg wet weight (10•2±9•0_108 colony-forming units) BCG Connaught substrain (ImmuCyst®, Alfa Wassermann SpA, Bologna, Italy). Lyophilised (ie, freeze-dried) BCG is suspended in 50 mL bacteriostatic-free solution of 0•9% sodium chloride. After draining of the bladder, the suspension is infused intravesically through a Foley catheter. The solution is retained in the bladder for 120 min, followed by emptying of the bladder and removal of the catheter. The BCG-alone group is assigned one course of intravesical treatment per week for 6 weeks. Patients in the BCG-alone group who are disease-free 3 months after treatment are scheduled to receive monthly infusions of BCG for 10 months
16193899|NCT01442519|Drug|electromotive mitomycin|BCG instillation of 81 mg BCG Connaught-substrain, suspended in 50 mL bacteriostatic-free saline solution, retained for 120 min. Electromotive instillation: 40 mg mitomycin in 100 mL water infused intravesically and retained in the bladder for 30 min, while 20 mA for 30 min pulsed electric current is given externally. Patients assigned sequential BCG and EMDA MMC are assigned 1 course of treatment/week for 9 weeks: one cycle consisted of two BCG infusions and one mitomycin infusion (three cycles in total). Patients in the BCG-and-mitomycin group who are disease-free 3 months after treatment are scheduled to receive one infusion a month for 9 months: three cycles of mitomycin, mitomycin, and BCG (ie, six infusions of MMC and three of BCG).
16193902|NCT01442493|Other|Patient-Centered Methadone Treatment|Unlike in treatment as usual, counseling will be encouraged but not required and counselors will be responsible for enforcing the clinic's rules. The rules will be enforced by the Clinical Director. Clinic rules will be modified such that involuntary discharge from treatment will be a rare event.
16193903|NCT01442493|Other|Methadone Treatment as usual|Counseling will be required and counselors will enforce the usual clinic rules. Involuntary discharge may occur for ongoing drug use or rule infractions as usually occurs in the clinic.
16193904|NCT01442480|Dietary Supplement|Fish oil|Subjects (ages 50 to 75 years), were randomly assigned to receive 3 g/d of fish oil (1.2 g eicosapentaenoic acid and 0.82 g docosahexaenoic acid) for 28 d.
16193905|NCT01442480|Dietary Supplement|Olive oil|Subjects (ages 50 to 75 years) were randomly assigned to receive 3 g/d of olive oil for 28 d.
16193906|NCT01442454|Other|chronic pancreatitis|No intervention, subjects followed through surgery
16193907|NCT01442428|Drug|Dexamethasone|Dexamethasone: 4 mg 3x daily for 2 weeks, then 2x daily for 1 week, then once daily for 1 week
16193908|NCT01442428|Drug|Atorvastatin|Atorvastatin: 80 mg once daily (equivalent to 30mg ± 10mg with rifamycin co-administration in this TB population)
16193909|NCT01442428|Drug|Naproxen|Naproxen: 250 mg 3x daily for 2 weeks, then 2x daily for 1 week, then once daily for 1 week
16193910|NCT01442428|Drug|Placebo|Atorvastatin placebo
16193911|NCT01442415|Behavioral|Lifestyle modification|Weekly lifestyle modification sessions including dietary counseling and physical activity
16193912|NCT01442376|Drug|Palonosetron|Single dose Palonosetron IV 10 mcg/kg up to a maximum total dose of 0.75 mg
16193913|NCT01442376|Drug|Palonosetron|Single dose Palonosetron IV 20 mcg/kg up to a maximum total dose of 1.5 mg
16193914|NCT01442376|Drug|Ondansetron|Single three (every 4 hours) Ondansetron IV doses 0.15 mg/kg up to a maximum total dose of 32 mg
16193915|NCT01442376|Drug|Placebo to Ondansetron|
16193916|NCT01442376|Drug|Placebo to Ondansetron|
16193917|NCT01442376|Drug|Placebo to Palonosetron|
16193918|NCT01442363|Drug|BLI-1300 low dose|topical ointment
16193919|NCT01442363|Drug|BLI-1300 high dose|topical ointment
16193920|NCT01442363|Drug|placebo|topical ointment
16193921|NCT01442337|Drug|ASP8597|one time IV dose
16193922|NCT01442337|Drug|Placebo|one time IV dose
16193923|NCT01442324|Procedure|Irreversible electroporation (IRE)|Needle-like electrodes are inserted through the liver and in the lesion without exceeding its deepest margin, at which point the IRE NanoKnife™ System (AngioDynamics) is started.
16193924|NCT01442311|Other|enhanced DOT (both pegylated interferon alfa-2a and ribavirin)|Subjects randomized to the PEG/RBV-DOT arm receive weekly provider-administered pegylated interferon alfa-2a injections plus modified directly observed ribavirin therapy. We describe this as modified because ribavirin ingestion is observed at the methadone window three to six days per week based on the participants' methadone pick-up schedule, and only one of two daily doses is observed.
16193925|NCT01442311|Other|standard DOT (PEG-DOT control arm)|Subjects randomized to the Peg-DOT arm receive standard on-site treatment (weekly provider-administered pegylated interferon alfa-2a injections) and self-administered twice-daily oral ribavirin. Subjects in the PEG-DOT arm are dispensed monthly medication bottles of ribavirin, and ingest the ribavirin at home.
16193926|NCT01442298|Procedure|Limb occlusion pressure (LOP)|The tourniquet cuff pressure were decided by measurement of limb occlusion pressure (LOP) using an automated photo plethysmographic sensor connected to a ATS 3000 tourniquet apparatus (Zimmer Sweden Inc®).
16193927|NCT01442298|Procedure|conventional measurement method|Standard method at our department, the tourniquet cuff pressure was based on the patient's systolic blood pressure and a margin that were decided by the surgeon.
16193928|NCT01442285|Behavioral|personalized, motivational messages|A Healthcare Provider Report will be printed after each assessment and reviewed by the subject's oncologist. If any mental health functioning scale scores fall in the elevated or high range, a treatment plan will be constructed. Subjects will receive a personalized Patient Feedback Report after each assessment which will include motivationally tailored messages and suggestions for action.
16193929|NCT01442272|Drug|Hidroferol®|Hidroferol® drinkable ampoule in oral solution, 266 mcg (1 drinkable ampoule) each 15 days during 12 months
16193930|NCT01442272|Drug|Paricalcitol: Zemplar®|Paricalcitol (Zemplar®) oral capsule , 1 mcg (1 capsule)each 24 hours during 12 months
16193931|NCT01442272|Drug|Habitual medication|Habitual medication
16193932|NCT01442259|Drug|AFQ056|
16193933|NCT01442246|Drug|Leuprorelin Acetate|Leuprorelin Acetate 45 mg, one injection every 6 months for 24 months
16193934|NCT01442233|Procedure|plasma exchange|6 plasma exchange each 48 hours during 2 weeks after randomization
16193935|NCT01442233|Procedure|sham exchanges procedure|6 sham exchanges each 48 hours during 2 weeks after randomization
16193936|NCT01442207|Procedure|Placement of a Cervical Cerclage|Surgical placement of a cervical cerclage
16193937|NCT01442207|Procedure|Standard Expectant Management|"Participants assigned to the expectant management group will be followed by their doctor and managed per standard management which includes:
~Standard management for placenta previa.
~Hospital admission for vaginal bleeding/hemorrhage
~Antenatal corticosteroids > 24w0d of gestation
~Tocolytic therapy per physician's discretion
~Magnesium sulfate for neuroprotection
~Fetal Heart Rate Monitoring
~Avoidance of digital examinations of the cervix
~Elective delivery no earlier than 36w0d gestation unless indicated (uncontrolled hemorrhage, imminent delivery, PROM > 34 wks, worsening maternal or fetal condition )
~Fetal Fibronectin (fFN) test collected at the time of transvaginal Ultrasound."
16193938|NCT01442194|Drug|other disease-modifying therapy|
16193939|NCT01442194|Drug|Fingolimod|
16193940|NCT01442181|Procedure|Minimally Invasive Surgery|Small thumb sized incisions are made on each side of the chest wall where instruments are inserted for the purpose of completing the surgery.
16193941|NCT01442181|Other|Medical therapy|Patients are treated with rhythm and rate control medications.
16193942|NCT01442168|Drug|Sevuparin sodium + atovaquone/proquanil|Sevuparin 4 times per day and malanil according to label
16193943|NCT01442168|Drug|atovaquone/proquanil|malanil according to label
16193944|NCT01442155|Drug|Capecitabine|Administered according to the Summary of Product Characteristics.
16193945|NCT01442155|Biological|Oxaliplatin|Administered according to the Summary of Product Characteristics.
16193946|NCT01442142|Behavioral|CAAT: Appetite Awareness|"Participants in this Children's Appetite Awareness Training (CAAT) group learn to get in touch with the internal cues of hunger - aka the hunger meter - and practice skills to get back in touch with these internal cues of true hunger and fullness. Sessions occur once a week for 8 weeks."
16193947|NCT01442142|Behavioral|CRST: Volcravo|"Participants in this Cue Reactivity and Sensitivity Training (CRST) group learn about how external cues can affect when and how much we eat (aka volcravo - the craving volcano). Over 8 weekly sessions, they practice skills to ride out the cravings external cues can cause."
16193948|NCT01442142|Behavioral|Combined CAAT and CRST program|Participants meet weekly for 14 weeks to learn about both Children's Appetite Awareness Training (CAAT) and Cue Reactivity and Sensitivity Training (CRST) - i.e. appetite awareness and external cues that affect food intake.
16193949|NCT01442129|Biological|MPC Intramyocardial injection|Intramyocardial injection of 25 million mesenchymal precursor cells at the time of LVAD implantation
16193950|NCT01442129|Biological|Control Solution|Injection of control solution during the LVAD implantation.
16193951|NCT01442116|Procedure|stress echocardiography|safety and efficacy of stress echocardiography
16193952|NCT01442103|Device|Normlgel Ag|Normlgel Ag dressing will be changed together with planned investigation visits. Dressing changes between visits will be performed at home on Day 3 or 4 of each week by subject or caregiver and documented in a dressing log.
16193953|NCT01442090|Drug|Everolimus|Everolimus will be administered orally at a 10 mg daily dose.
16193954|NCT01442090|Drug|GDC-0980|GDC-0980 will be administered orally at a 40 mg daily dose.
16193955|NCT01442077|Device|Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)|Series of 12 treatments, in which the subject will be treated twice a week for 3 weeks (6 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for 3 weeks (6 treatments).
16193956|NCT01442077|Device|Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)|Series of 12 treatments, in which the subject will be treated twice a week for 6 consecutive weeks, without intermission.
16193957|NCT01442077|Device|Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)|Series of 8 treatments, in which the subject will be treated twice a week for two weeks (4 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated twice a week for two weeks (4 treatments).
16193958|NCT01442077|Device|Extracorporeal Shockwave Therapy Generator (Omnispec ED1000)|Series of 6 treatments, in which the subject will be treated once a week for 3 weeks (3 treatments), then would be discontinuation of the study for 3 weeks, and at the end of this period will be treated once a week for 3 weeks (3 treatments).
16193959|NCT01442064|Drug|Ranibizumab 0.5 mg|Ranibizumab intravitreal injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year).
16193960|NCT01442051|Procedure|Acute Normovolemic Hemodilution|A predetermined volume of whole blood will be removed from these patients based on an established protocol. Crystalloid and colloid will then be infused to replace intravascular volume based on this protocol. Patients will be closely monitored intraoperatively with serum arterial hemoglobin (HgB) levels drawn hourly. Patients will be transfused with autologous blood if HgB < 7.0 g/dL. If the volume of autologous blood has not been transfused within eight hours or by the completion of the procedure, the remainder will be transfused at that time. If the volume of autologous blood has been transfused and the patients require additional blood transfusions (HgB <7g.dL), allogenic blood will be transfused thereafter. These transfusion triggers are based on common intraoperative practice patterns. Patients may also be transfused intraoperatively at any time for a HgB ≥ 7.0 g/dL based on the judgment of the attending anesthesiologist or surgeon but the reason will be recorded.
16193961|NCT01442038|Drug|Ranolazine|"Subjects will receive ranolazine 500 milligrams (mg) twice daily for 7 days, followed by 1000 mg administered orally twice daily for the duration of the study.
~Subjects receiving a moderate CYP3A4 inhibitor will receive ranolazine 500 mg or placebo administered orally twice a day for the duration of the concomitant therapy."
16193962|NCT01442038|Drug|Placebo|"Subjects will receive one tablet of matching placebo twice daily for 7 days, followed by two tablets of matching placebo twice daily for the duration of the study.
~Subjects receiving a moderate CYP3A4 inhibitor will receive ranolazine 500 mg or placebo administered orally twice a day for the duration of the concomitant therapy."
16193963|NCT01442025|Drug|Infliximab|Perfusion of IFX 5mg/kg to be increased to 10 mg/kg based on clinical symptoms
16193964|NCT01442025|Drug|Infliximab|Perfusion of IFX 5mg/kg or 10 mg/kg if dose increase criteria are met (biological)
16193965|NCT01442025|Drug|Infliximab|Perfusion of IFX 5mg/kg or 7,5 mg/kg if dose increase criteria are met (biological)and 10mg/kg if dose increase criteria are met for a second time
16193966|NCT01442012|Other|Ear seeds|The investigators will use ear seeds to stimulate acupuncture points. The seeds will be applied when the patients are in the preoperative room. After the patients have been discharged, they will need to stimulate these points every eight hours for five minutes, and every time they have nausea and/or vomiting during the first three postoperative days.
16193967|NCT01441999|Device|Less rigid rod|Titanium rod with semi rigid end
16193968|NCT01441999|Device|Rigid Rod|Rigid Titanium rods
16193969|NCT01441986|Drug|Dextromethorphan hydrobromide|Dextromethorphan hydrobromide•1 H2O; 30 mg; hard capsules; single, oral dose.
16193970|NCT01441986|Drug|Amantadine|Amantadine hydrochloride 100 mg; tablets; single, oral dose.
16193971|NCT01441986|Drug|Pacebo 1 (placebo for Amantadine)|Talets for oral use; single dose.
16193972|NCT01441986|Drug|Placebo 2 (fo Dextromethorphan)|Capsles for oral administration; single dose.
16193973|NCT01441973|Biological|Elotuzumab (BMS-901608; HuLuc63)|
16193974|NCT01441960|Drug|Succinylcholine|Succinylcholine will be given during the series of ECT treatments. The initial dose will be defined by the anesthesiologist in charge for clinical care. The Dixon's up and down method will be used in consecutive treatments. The investigators will switch to the second compound as soon as the patient has received one neuromuscular blocking agent dose that resulted in 'acceptable muscle relaxation', and another dose that resulted in 'unacceptable' conditions'.
16193975|NCT01441960|Drug|Rocuronium|Rocuronium will be given during the series of ECT treatments. The initial dose will be defined by the anesthesiologist in charge for clinical care. The Dixon's up and down method will be used in consecutive treatments.
16193976|NCT01441947|Drug|Cabozantinib|Part of combination arm
16193978|NCT01441934|Drug|Sildenafil citrate|sildenafil 20 mg t.i.d. compared to placebo 20 mg t.i.d - 16 weeks treatment
16193979|NCT01441934|Drug|Sugar pills|placebo t.i.d.
16193980|NCT01441921|Dietary Supplement|Pistachios|"Participants are randomised crossover clinical trial of 4-months trials separated by a 2-week washout period.
~Total duration of intervention and follow-up is nine months."
16193981|NCT01441921|Other|control diet|"Participants are randomised crossover clinical trial of 4-months trials separated by a 2-week washout period.
~Total duration of intervention and follow-up is nine months."
16193982|NCT01441908|Drug|Pravastatin|40mg or 80mg dose 28 days for 6 month period
16193983|NCT01441882|Drug|Dasatinib|Given PO
16193984|NCT01441882|Other|Laboratory Biomarker Analysis|Correlative studies
16193985|NCT01441882|Other|Pharmacological Study|Correlative studies
16193986|NCT01441869|Drug|Onglyza (saxagliptin)|Oral tablets, 5 mg , single dose
16193987|NCT01441869|Drug|Diabex|Extended release oral tablets, 1000 mg, single dose
16193988|NCT01441869|Drug|5-mg saxagliptin/1000 mg metformin|Extended release fixed dose combination tablet, single dose
16193989|NCT01441869|Drug|Diabex|Extended release oral tablets, 500 mg, single dose
16193990|NCT01441869|Drug|5-mg saxagliptin/500 mg metformin|Extended release fixed dose combination tablet, single dose
16193991|NCT01441856|Procedure|Open or Laparoscopic left hemihepatectomy|Patients in this arm will undergo a left hemihepatectomy within an Enhanced Recovery After Surgery Program.
16193992|NCT01441856|Procedure|Open or Laparoscopic right hemihepatectomy|Patients in this arm will undergo a right hemihepatectomy within an Enhanced Recovery After Surgery Program.
16193993|NCT01441843|Drug|Lorazepam|Once 1mg <75kg body weight, 1.5mg 75kg and >75kg body weight, IV, before surgery
16193994|NCT01441843|Drug|NaCl 0.9% (Sodium Chloride)|Once 1ml <75kg body weight, 1.5ml 75kg or >75kg body weight, IV, before surgery
16193995|NCT01441830|Device|Radial extracorporeal shock wave therapy|The shockwave treatment will be administered once a week for four weeks on one to three specific points (supraspinatus, infraspinatus or subscapular tendon)and with a pressure between 1,5-3 Bar
16193996|NCT01441817|Procedure|Internal fixation|Internal fixation of the medial malleolus following open reduction and internal fixation of the lateral and, if required, posterior malleolus.
16193997|NCT01441804|Drug|Peginterferon alfa2a|patients receive a dose of 180 µg of PEGASYS once a week for 24 weeks
16193998|NCT01441804|Drug|Ribavirin|patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 24 weeks
16193999|NCT01441804|Drug|Peginterferon alfa2a|patients receive a dose of 180 µg of PEGASYS once a week for 48 weeks
16194000|NCT01441804|Drug|Ribavirin|patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks
16194001|NCT01441791|Procedure|Lung protective strategy ventilation|Patients are randomized and intra-operatively ventilated with a lung protective strategy (PEEP at 12 cmH2O with recruitment maneuvers)
16194002|NCT01441778|Drug|NSS nasal irrigation salt|nasal irrigation twice daily for 4 weeks period
16194003|NCT01441778|Drug|BHS nasal irrigation salt|nasal irrigation twice daily for 4 weeks period
16194004|NCT01441765|Drug|CT-011|CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks
16194005|NCT01441765|Biological|DC/RCC fusion vaccine|Vaccination once per cycle on Day 8 of treatment cycles 2-4
16194006|NCT01441752|Drug|TCM|three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe.
16194007|NCT01441752|Drug|placebo|three types with functions such as benefiting Qi recipe, benefiting Yin recipe and detoxication and resolving masses recipe，with the same color, smell ，taste weight and package
16194008|NCT01441700|Procedure|Prone and Supine emergence from anaesthesia|Aims: The aim of this study was to compare haemodynamic changes and to evaluate the incidence of coughing, laryngospasm, loss of monitoring in patients undergoing lumbar disc surgery extubated in prone position and supine position. Settings and design: This open-level prospective randomized study was carried out in 50 patients who were admitted for elective lumbar surgery. Methods: The patients were randomly allocated to one of the two groups of 25 each at conclusion of surgery. First group was extubated in prone position and second in supine position at conclusion of surgery. Supine group patients were rolled back and prone group patients were left undisturbed. Extubation was done after complete reversal of neuromuscular block. Heart rates, Mean Arterial Pressure were noted at various points of time. Coughing, laryngospasm, vomiting, monitor disconnection if any were also noted. Statistical methods: Data was analyzed using
16194009|NCT01441687|Other|laboratory biomarker analysis|Correlative studies
16194010|NCT01441687|Procedure|transrectal prostate biopsy|Undergo prostate biopsy
16194011|NCT01441674|Behavioral|Animal Assisted Therapy|There will be a therapy dog and dog trainer present working with the patient for the AAT arm.
16194012|NCT01441648|Other|contact lens wear|tinted contact lens wear
16194013|NCT01441635|Drug|Elagolix|Elagolix tablets
16194014|NCT01441635|Drug|Placebo|Matching placebo tablets
16194015|NCT01441635|Drug|Estradiol/Norethindrone acetate (E2/NETA)|A continuous once-daily oral tablet containing estrogen and progestin; the low-dose strength contains estradiol 0.5 mg and norethindrone acetate 0.1 mg.
16194016|NCT01441635|Drug|Estradiol|1.0 mg micronized estradiol tablets administered once a day
16194017|NCT01441635|Drug|Progesterone|Progesterone 200 mg administered during the last 12 days of the 28-day menstrual cycle
16194018|NCT01441622|Device|AL539 (SRETT)|recording data with AL539 (SRETT)
16194019|NCT01441596|Drug|Vinorelbine|Vinorelbine 25 mg/mÂ² on days 1, 8, 15 in a 3-weekly course
16194020|NCT01441596|Drug|Investigator's choice of treatment|Patients will receive, at the investigator's discretion, the most appropriate medical treatment consisting of single agent or combination regimen approved for the treatment of metastatic breast cancer, and according to patient status and local guidelines.
16194021|NCT01441596|Drug|afatinib|Afatinib monotherapy:once daily, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
16194022|NCT01441596|Drug|afatinib|Afatinib monotherapy:once daily, continuous treatment in a 3-weekly course. If well tolerated, the dose may be escalated to 50 mg.
16194023|NCT01441583|Device|RAAT|For Pacemaker and CRT-P: Right Atrial Automatic Threshold (RAAT)
16194167|NCT01440569|Drug|COBI|150 mg tablet administered orally with food once daily
16194024|NCT01441583|Device|RYTHMIQ|For pacemakers only: RYTHMIQ RYTHMIQ randomized to on at pre-discharge or at 1-month, depending on assignment
16194025|NCT01441570|Drug|Nebivolol|Subject will take nebivolol daily for 12 weeks.
16194026|NCT01441570|Drug|Metoprolol succinate|Subject will take metoprolol succinate daily for 12 weeks.
16194027|NCT01441557|Drug|3,4-diaminopyridine|test dose 10 mg then 20 mg, then depending on tolerance and efficacy full-dose administration(from 10mg /8h to 20 mg /8h)
16194028|NCT01441544|Behavioral|Variety of Active Videogames|Thirty men and women, aged 18- to 35- years, recruited from the local area, with a normal body mass index (BMI) between 18.5 and 29.9 kg/m, will participate in two experimental sessions, VARIETY (playing the same active video game over 4 sessions) and NON-VARIETY (playing 4 different active video games over 4 sessions), with order of experimental sessions counterbalanced across participants.
16194029|NCT01441531|Drug|gabapentin 600 mg po|Given one hour before surgery
16194030|NCT01441531|Drug|Placebo pill given one hour before surgery|Placebo pill given
16194031|NCT01441518|Other|Home care|"Home care, sometimes called ambulatory care or outpatient, was defined as the blood-glucose self-monitored by the pregnant women at home. This project will provide glucometers to all those who are randomized to home care. The women will receive training for glucose control in pre-defined days, with the glucometer to obtain the mean glucose. According to blood-glucose levels in glycemic profile, insulin dose will be maintained or altered both in gestational diabetes as in mild gestational hyperglycemia ."
16194032|NCT01441518|Other|Hospital care|"Hospital care, sometimes called acute care, was defined as control of maternal diabetes made at hospitals by admission to hospital. The blood-glucose and metabolic control are done in gestational diabetes and mild gestational hyperglycemia treated conventionally.
~The hospitalized patients will have their glycemic control done in the hospital. . According to blood-glucose levels in glycemic profile , insulin dose will be maintained or altered both in gestational diabetes as in mild gestational hyperglycemia.
~All the women of the study will be accompanied by a team of obstetricians specializing in high-risk pregnancies; residents; dietitians; nurses and neonatologists."
16194033|NCT01441505|Drug|Ketamine|Ketamine IV, IM, or SC will be administered in Phase I and II
16194034|NCT01441505|Drug|Saline or Midazolam (active placebo)|Saline, or midazolam 0.01mg/kg will be administered in Phase I
16194035|NCT01441492|Procedure|No Drains|A closed-suction drain will not be placed near the transection margin at the time of surgery in the experimental group.
16194036|NCT01441492|Procedure|Drains|A drain will be placed near the pancreatic transection margin at the time of surgery (standard of care).
16194037|NCT01441479|Device|In Vitro Diagnostic Device aid in diagnosing|
16194038|NCT01441466|Other|Isolation|Patients in this arm are nursed together (in the same room) independent of viral agent
16194039|NCT01441453|Procedure|FibroScan (Transient Elastography measurement)|Preoperative evaluation of liver stiffness through FibroScan
16194040|NCT01441440|Drug|venlafaxine ER 75 mg/day (fixed dose)|Treatment phase: 8 weeks (37.5 mg/day for 1st week and 75 mg/day for 7 weeks), oral administration Tapering phase: 2 weeks (37.5 mg/day for the 1st week and placebo for the 2nd week), oral administration
16194041|NCT01441440|Drug|venlafaxine ER 75 mg/day to 225 mg/day (flexible dose)|Treatment phase: 8 weeks (37.5 mg/day for the 1st week, 75 mg/day for the 2nd weeks, 75-150 mg for the 3rd week, 75-225 mg/day for the rest of 5 weeks), oral administration Tapering phase: 2 weeks (75/37.5 mg/day for the 1st week and 37.5 mg/day/placebo for the 2nd week), oral administration
16194042|NCT01441440|Drug|Placebo|Treatment phase: 8 weeks (placebo), oral administration Tapering phase: 2 weeks (placebo), oral administration
16194043|NCT01441427|Drug|recombinant human G-CSF, and rhEPO|G-CSF 4.5 microgram /kg/day enteral EPO 88 mIU/kg/day enteral
16194044|NCT01441427|Drug|rh G-CSF|Dosage: 4.5 µg/ kg (diluted into 1 ml distilled water) administered once daily by an orogastric tube till the enteral intake reached 100 mL/kg of milk, or after a maximum of seven days.
16194045|NCT01441427|Drug|rh EPO|Dosage: 88 IU/ kg once daily (diluted into 1 ml distilled water) administered by an orogastric tube till the enteral intake reached 100 mL/kg of milk, or after a maximum of seven days.
16194046|NCT01441427|Drug|rh G-GSF and rh EPO together|EPO dosage: 88 IU/ kg once daily i.e 88000 mU/kg/day (diluted into 1 ml distilled water) administered by an orogastric tube till the enteral intake reached 100 mL/kg of milk, or after a maximum of seven days.G-CSF dosage: 4.5 µg/ kg (diluted into 1 ml distilled water) administered once daily by an orogastric tube till the enteral intake reached 100 mL/kg of milk, or after a maximum of seven days.
16194047|NCT01441427|Drug|Placebo|distilled water :1 ml distilled water administered by an orogastric tube till the enteral intake reached 100 mL/kg of milk, or after a maximum of seven days.
16194048|NCT01441414|Biological|PF-04856884|15 mg/kg/week intravenously [IV] until toxicity or disease progression
16194049|NCT01441414|Drug|Axitinib (AG-013736)|5 mg PO BID
16194050|NCT01441414|Drug|Axitinib (AG-013736)|5 mg PO BID
16194051|NCT01441401|Drug|gabapentin|According to Japanese Package Insert: For infants and children aged 3 to 12 years, a daily dosage of 10 mg/kg of gabapentin should be administered orally in 3 divided doses on the first day of treatment, and an effective dosage of 20 mg/kg should be administered to them in 3 divided doses on day 2. From day 3 on, infants aged 3 to 4 years should be maintained on the dosage of 40 mg/kg, and children aged 5 to 12 years on the dosage of 25 to 35 mg/kg administered orally in 3 divided doses, respectively (the maximum daily dosage: 1800 mg). Though the maintenance dosage may be adjusted depending on the patient's condition, the maximum daily dosage should be 50 mg/kg. At any time point, dosage should not exceed that the dosage for adults and children aged 13 years.As for children aged 13 years or over is as same as administration for adult.
16194052|NCT01441388|Drug|Crizotinib plus VEGF inhibitor combinations|Three combinations will be prioritized, namely crizotinib plus axitinib, crizotinib plus sunitinib and crizotinib plus bevacizumab, with a fourth combination, crizotinib plus sorafenib to be tested only if crizotinib does not combine with either axitinib and/or sunitinib. All study drugs are tablets or capsules except for bevacizumab which is parenteral (intravenous). Dosage, frequency and duration to be determined.
16194053|NCT01441388|Drug|Crizotinib plus axitinib|Study drugs are tablets or capsules; dosage, frequency and duration to be determined.
16194054|NCT01441388|Drug|Crizotinib plus sunitinib|Study drugs are tablets or capsules; dosage, frequency and duration to be determined.
16194055|NCT01441388|Drug|Crizotinib plus axitinib|Study drugs are tablets or capsules; dosage, frequency and duration to be determined.
16194056|NCT01441388|Drug|Crizotinib plus sunitinib|Study drugs are tablets or capsules; dosage, frequency and duration to be determined.
16194057|NCT01441388|Drug|Crizotinib plus bevacizumab|Study drugs are tablets or capsules except for bevacizumab which is parenteral (intravenous). Dosage, frequency and duration to be determined.
16194058|NCT01441388|Drug|Crizotinib plus sorafenib|Study drugs are tablets or capsules; dosage, frequency and duration to be determined.
16194059|NCT01441362|Procedure|90 degrees rotation|Double-lumen tube intubation with 90 degrees rotation
16194060|NCT01441362|Procedure|180 degrees rotation|Double-lumen tube intubation with 180 degrees rotation
16194061|NCT01441349|Drug|IP chemotherapy|"Irinotecan/cisplatin (IP) chemotherapy
~Cisplatin(30 mg/m2) diluted into 150 ml of 0.9% NS for IV over 30 min on day 1 &8.
~Irinotecan(65mg/m2) diluted into 200ml of 5DW IV over 90 min on day 1 & 8
~Every 21 days"
16194062|NCT01441349|Drug|IP chemotherapy plus simvastatin|"Cisplatin(30mg/m2)diluted into 150 ml of 0.9% NS for IV over 30 min on day 1 &8
~Irinotecan( 65 mg/m2) diluted into 200ml of 5DW IV over 90 min on day 1& 8.
~Every 21days.
~Simvastatin 40 mg per day orally D1of cycle 1"
16194063|NCT01441336|Procedure|Laparoscopic gastrectomy|Operative procedure: laparoscopic gastrectomy(D2 lymphadenectomy according to JGCA guideline and total omentectomy for tumor with serosa exposure)
16194064|NCT01441323|Behavioral|Nutrition|Nutrition classes for 1 hour & 30 minutes once a week for 16 weeks + motivational interviewing (4 individual sessions)
16194065|NCT01441323|Behavioral|Strength Training & Nutrition|Strength Training twice a week for 1 hour a day for 16 weeks + Nutrition once a week for 1 hour & 30 minutes for 16 weeks + motivational interviewing (4 individual & 4 group sessions)
16194066|NCT01441310|Procedure|Laparoscopic sentinel node navigation surgery|Laparoscopic SNNS using simultaneous indocyanine green (ICG) and 99mTc-antimony sulfur colloid (ASC) injections
16194067|NCT01441297|Drug|BIBF 1120|BIBF 1120 200mg bid, PO, daily until PD
16194068|NCT01441284|Drug|pramipexole|pramipexole extended release, 2.1 mg pramipexole base (3.0mg pramipexole salt) once daily
16194069|NCT01441284|Drug|placebo|placebo
16194070|NCT01441271|Procedure|Ileal diversion and lavage|The surgical approach involves an attempted laparoscopic creation of a loop ileostomy after visually assessing the colon to assure viability. If the loop is unable to be safely performed laparoscopically an open loop ileostomy will be performed. Intraoperatively, 8 liters of warmed polyethylene glycol 3350/electrolyte solution [GoLytely®; Braintree Laboratories] will be infused into the colon via the ileostomy and collected via a rectal drainage tube. Post-operatively, the patients will receive antegrade vancomycin flushes [500 mg in 500 ml of Lactated Ringers; q8 hours for duration of 10 days] via a Malecot catheter [24 French] left in the efferent limb of the ileostomy (Figure 1). Additionally patients will be continued on intravenous metronidazole [500mg q8 hours] for 10 days.
16194071|NCT01441271|Procedure|total abdominal colectomy|The surgical approach of the colon in a total abdominal colectomy involves a midline incision. The complete colon in the abdomen (from ileum to rectum) will be removed and an end ileostomy is performed.
16194072|NCT01441258|Behavioral|Dialectical Behavior Therapy Skills (DBT-S) Groups|The intervention will be delivered within an 18-week, once-weekly, one-and-half-hour skill group (8 participants per group) comprised of the same four modules administered in standard DBT skills training groups: (1) mindfulness, (2) interpersonal effectiveness, (3) emotion regulation, and (4) distress tolerance. There will be four sessions for each module totaling 16 sessions. There will be two booster sessions reviewing mindfulness and the concept of dialectics in-between each of the modules (i.e., between modules 2 and 3 and 3 and 4).
16194073|NCT01441258|Behavioral|Wait List-Treatment as Usual|Participants will be seen by their standard treaters for 18 weeks as usual.
16194074|NCT01441258|Behavioral|No intervention-treatment as usual|Participants will receive the intervention after 18 weeks in the treatment as usual group.
16194075|NCT01441245|Drug|furosemide infusion|Patients were randomized in a 1:1 ratio to receive furosemide dose divided into twice-daily bolus injection (group 0) or continuous infusion (group 1)(mixed as a 1:1 ratio in 5% dextrose in water) for a time period ranging from 72 to 120 hours. The mean daily diuretic dosage was similar in the two groups. The median time from presentation to randomization was 16 hours, and the median duration of study-drug administration was 112± 24 hours
16194076|NCT01441232|Drug|LX4211|400 mg of LX4211 administered as two 200 mg tablets
16194077|NCT01441232|Drug|Januvia®|100 mg Januvia® (sitagliptin) administered as one 100 mg sitagliptin tablet
16194078|NCT01441219|Device|Colon 2|Ingest one colon 2 capsule
16194079|NCT01441206|Drug|rifampin|"Infants who will be receiving up to 4 doses of rifampin per protocol(Cohort 1)
~Cohort 1:
~Dosing will be as follows:
~GA at birth < 32 weeks - PNA < 14 days: 10 mg/kg QD GA at birth < 32 weeks - PNA ≥ 14 days: 15 mg/kg QD GA at birth ≥ 32 weeks - PNA < 14 days: 15 mg/kg QD GA at birth ≥ 32 weeks - PNA ≥ 14 days: 20 mg/kg QD"
16194080|NCT01441193|Biological|HIV-1 Tat/delta-V2 Env combined vaccine|
16194081|NCT01441193|Biological|HIV-1 delta-V2 Env vaccine|
16194082|NCT01441193|Biological|HIV-1 Tat vaccine 7.5 microg|
16194083|NCT01441193|Biological|HIV-1 Tat vaccine 30 microg|
16194084|NCT01441180|Drug|GS7977|drug intervention
16194085|NCT01441180|Drug|RBV|drug intervention
16194086|NCT01441167|Biological|PfSPZ|
16194087|NCT01441128|Drug|PF-02341066/PF-00299804|Combined PF-02341066 and PF-00299804
16194088|NCT01441128|Drug|PF-02341066/PF-00299804|Single Agent PF-00299804 followed by Combined PF-02341066 and PF-00299804
16194089|NCT01441115|Procedure|Radiation Therapy|
16194090|NCT01441115|Drug|ECI301|
16194091|NCT01441102|Drug|Dextromethorphan hydrobromide|Participants instructed to take 60 mg dextromethorphan capsules orally two times a day for 24 months.
16194092|NCT01441076|Drug|Anakinra|Anakinra/Kineret[registered] is a recombinant, non-glycosylated form of the human interleukin-1 receptor antagonist (IL-1Ra)
16194093|NCT01441063|Drug|Zidovudine|Zidovudine (AZT) 600 mg orally q6 hours (every 6 hours)
16194094|NCT01441063|Drug|Tocilizumab|Tocilizumab 8mg/kg every 2 weeks
16194095|NCT01441063|Drug|Valganciclovir (VGC)|Valganciclovir (VGC) 900 mg orally q12 hours (every 12 hours) on days 1-5 of a 14-day cycle.
16194096|NCT01441037|Drug|Danazol|Danazol, 800 mg daily by mouth for 2 years
16194097|NCT01441024|Drug|DAS181|20 mg per day of DAS181-FO3 for 5 days
16194098|NCT01441024|Other|Placebo|20 mg per day of Lactose for 5 days
16194099|NCT01441011|Behavioral|Group phone counseling|Bi-weekly phone counseling sessions from 6 - 18 months
16194100|NCT01441011|Behavioral|Newsletter|Bi-weekly newsletter mailings from 6 - 18 months
16194101|NCT01440998|Drug|Carboplatin|Given IV
16194102|NCT01440998|Drug|Dasatinib|Given PO
16194103|NCT01440998|Other|Laboratory Biomarker Analysis|Correlative studies
16194104|NCT01440998|Drug|Paclitaxel|Given IV
16194105|NCT01440985|Drug|Nicotine|Nicotine Gum 2 mg, Lot number GD922A
16194106|NCT01440985|Drug|Nicotine|Nicotine gum 4 mg, Lot number GC962A
16194107|NCT01440985|Drug|Nicotine|Nicotine Microtab 2 mg, Lot number GB196G
16194108|NCT01440972|Other|partial blood flow restriction (PBFR)|low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.
16194109|NCT01440972|Other|low intensity resistance training|low intensity resistance training without partial blood flow restriction
16194110|NCT01440959|Drug|dovitinib|TKI258 at 500 mg/day on a 5 days on/2 days off dosing schedule
16194111|NCT01440946|Drug|rFIXFc|Vials of rFIXFc were combined as needed, based on the actual labeled potency to achieve the participant's calculated dose. Partial vial use was allowed, in order to achieve the calculated dose.
16194112|NCT01440946|Drug|FIX|Vials of prestudy FIX (provided by the participants) were combined as needed, based on the nominal labeled potency (e.g., 250 IU, 500 IU, and 1000 IU), to achieve the participant's calculated dose.
16194113|NCT01440933|Drug|Magnesium Sulfate|1ml/kg of the study solution containing 60 mg/ml of magnesium sulphate are given intravenously over 15 minutes in the conscious patient. After anaesthesia induction and calibration of neuromuscular monitoring (TOF Watch SX - acceleromyography) 0,6 mg/kg of rocuronium is given intravenously. After recovery of the neuromuscular block to a posttetanic count of 2 (deep neuromuscular block) (PTC 2) or reappearance of 2 twitches of the Train of four (superficial neuromuscular block) 4 mg/kg (deep neuromuscular block) or 2 mg/kg (superficial neuromuscular block) of Sugammadex are given intravenously.
16194114|NCT01440933|Drug|Placebo comparator|1ml/kg of the study solution containing physiologic saline are given intravenously over 15 minutes in the conscious patient. After anaesthesia induction and calibration of neuromuscular monitoring (TOF Watch SX - acceleromyography) 0,6 mg/kg of rocuronium is given intravenously. After recovery of the neuromuscular block to a posttetanic count of 2 (deep neuromuscular block) (PTC 2) or reappearance of 2 twitches of the Train of four (superficial neuromuscular block) 4 mg/kg (deep neuromuscular block) or 2 mg/kg (superficial neuromuscular block) of Sugammadex are given intravenously.
16194115|NCT01440920|Drug|OCV-501|subcutaneously administered once a week, 4 times at the dose of 0.3 mg
16194116|NCT01440920|Drug|OCV-501|subcutaneously administered once a week, 4 times at the dose of 1 mg
16194117|NCT01440920|Drug|OCV-501|subcutaneously administered once a week, 4 times at the dose of 3 mg
16194118|NCT01440907|Other|Care Coordination Program|The Care Coordination Program includes: (1) access to a secure online personal health record (PHR) that people can logon and manage their health information, as well as receive alerts and reminders about action items for them to take on their healthcare; and (2) depending on the patient's health care needs, nursing support (either in-person or by phone).
16194119|NCT01440894|Device|Comparison test|"Reference Device: Transtek Glass Body Analyzer, GBF-950, accuracy: ±0.1kg and range: 0-180kg.
~DUT(Device Under Test): Transtek Glass Body Fat Analyzer, Model: GBF-733-W1, GBF-1012, BF-1039, BF-1041-A, and GBF-950-D."
16194120|NCT01440881|Drug|Nesiritide|infuses at 0.01MCG/KG/min for 48 hours
16194121|NCT01440881|Drug|Placebo|infuses at 0.01MCG/KG/min for 48 hours
16194122|NCT01440868|Procedure|Sustained lung inflation|Sustained lung inflation (SLI) will be performed with mask using a pressure control system (Neopuff, Fisher & Paykel, Inc). Peak inflation pressure (PIP) of 25 cm H2O will be delivered for 15 seconds and then reduced to a PEEP of 5 cm H2O. A second SLI manoeuvre will be repeated in case of persistent hearth failure (HR <100 bpm ).
16194123|NCT01440855|Other|CIS (Cancer Information Service) Information Sheet|CIS Fact Sheet, available on the Cancer Information Service website. Used to control for attention. 5-page document provides information about the CIS:What is it, How can CIS information specialists help me, How can I use CIS's services. Also includes definitions of glossary terms and a table of email and website addresses.
16194124|NCT01440855|Other|Facing Forward booklet|NCI's (NCI: National Cancer Institute) Facing Forward 61-page booklet, which describes common feelings and reactions that cancer survivors experience during the re-entry phase and offers behavioral recommendations to help them through this period, i.e., ways of dealing with common problems and guidelines for managing physical, social, and emotional health. Booklet sections: Congratulations on Finishing Your Cancer Treatment, Getting Follow-up Medical Care, Ways to Manage Physical Changes, Body Changes and Intimacy, Your Feelings, Social and Work Relationships, Reflection, 6-page Appendix, which provides information on Financial and Legal Matters, and Resource Organizations.
16194125|NCT01440842|Other|Closed-loop insulin delivery|Intravenous infusion delivery of Actrapid insulin and dextrose, dose calculated by Model Predictive Control (MPC) algorithm, based on continuous glucose sensor readings.
16194126|NCT01440842|Other|Standard IV insulin infusion sliding scale|Standard intravenous insulin infusion sliding scale as per intensive care unit protocol.
16194127|NCT01440829|Drug|L-ornithine-L-aspartate|The patients will be treated with LOLA (30g per day) for a week after TIPS procedure.
16194128|NCT01440816|Biological|Tavokinogene Telseplasmid (tavo)|Patients received intratumoral injection(s) of tavo.
16194129|NCT01440816|Device|OncoSec Medical System (OMS)|Electroporation via OMS was performed immediately following intratumoral injection of tavo. A sterile applicator containing 6 stainless steel electrodes arranged in a circle were placed around the tumor. The applicator was connected to the OMS power supply and six pulses were administered to each tumor lesion at the approximate point of tavo injection.
16194130|NCT01440803|Drug|Teriparatide|Daily injection of 20 mcg teriparatide for the treatment of idiopathic osteoporosis for 24 months.
16194131|NCT01440803|Drug|Saline Placebo|Daily injection of saline placebo for 6 months, followed by teriparatide treatment for 24 months.
16194132|NCT01440790|Dietary Supplement|glucose bolus|50g anhydrous glucose dissolved in 300ml water consumed within 10min followed by a lunch (cheese sandwich, fruit and milk) at 4h.
16194133|NCT01440790|Dietary Supplement|Glucose sipping|50g anhydrous glucose dissolved in 300ml water consumed at rate of 25ml per 15min followed by a lunch (cheese sandwich, fruit and milk) at 4h.
16194134|NCT01440790|Dietary Supplement|Glucose bolus plus 1g vitamin C|50g anhydrous glucose dissolved in 300ml water consumed within 10min with 1g vitamin C followed by a lunch (cheese sandwich, fruit and milk) at 4h.
16194135|NCT01440790|Dietary Supplement|Glucose sipping plus 1g vitamin C|50g anhydrous glucose dissolved in 300ml water consumed at rate of 25ml per 15min. 1g vitamin C taken with first 25ml. Followed by a lunch (cheese sandwich, fruit and milk) at 4h.
16194136|NCT01440777|Behavioral|Go! to Sleep|"The online program provides various tools for the delivery of the intervention including:
~Daily articles
~Daily activities to help get the sleep you need
~Daily sleep improvement recommendations
~Audio recorded relaxation exercises
~Daily e-mails from your program coach
~Personal progress charts
~An online sleep log and daily sleep score"
16194137|NCT01440764|Drug|Furosemide|
16194138|NCT01440764|Drug|Saline|
16194139|NCT01440751|Device|Use of ologen Collagen Matrix in trabeculectomy (ologen)|Place ologen CM on the top of the loosely-sutured scleral flap under conjunctiva before suturing. It is recommended to suture the scleral flap with 1 or 2 stiches loosely for the convenience of future suture lysis and to coordinate with the tamponading effect of ologen CM to create a fluctuating scleral flap that prevents bleb wound adhesion and modulates aqueous humor outflow for ideal IOP control without leakage.
16194140|NCT01440751|Drug|Use of Mitomycin-C (MMC) in trabeculectomy|After outlining and creating a superficial scleral flap, a cellulose sponge soaked with MMC(0.4mg/mL) is applied for up to 3 mins according to physician's routine method of application. The area treated is copiously irrigated with balanced isotonic solution. Alternatively, 15mcg of MMC may be injected intra-Tenon's at the end of the procedure. Patients receiving mitomycin will be billed as per operating room practice.
16194141|NCT01440738|Behavioral|health workshops|health workshops in relation to: Increase knowledge of healthy habits (physical activity, diet), incorporate and maintain a balanced diet. Incorporate and maintain regular physical activity
16194142|NCT01440725|Biological|Autologous Platelet-rich plasma (PRP)|4-8cc, a single dose
16194143|NCT01440725|Procedure|Evacuation of haematoma|Evacuation of the haematoma, a single procedure
16194144|NCT01440712|Drug|Gastrografin|Administration of 100 ml of gastrografin by the nasogastric tube, only once.
16194145|NCT01440712|Drug|physiological serum|Administration of 100 ml of physiological serum 0,9% by the nasogastric tube, only once.
16194146|NCT01440699|Biological|Allogenic human adipose-derived stem cells|ALLO-ASC 1xE7 cells/mL is injected once along the fistula. If there is no safety issue for 4 weeks, 3 more people could be enrolled who are subject to ALLO-ASC 3xE7 cells/mL.
16194147|NCT01440686|Drug|Somatropin|A single dose 5.0mg administered subcutaneously(under the skin) via Genotropin
16194148|NCT01440686|Drug|Placebo|Tablets, oral administrations
16194149|NCT01440673|Drug|Aprepitant|Aprepitant 80 mg, Aprepitant 125 mg
16194150|NCT01440647|Procedure|Extubation to NIPPV|After extubation infants were placed on NIPPV as soon as all the extubation criteria were met
16194151|NCT01440647|Procedure|Extubation to CPAP|After extubation infants were placed on CPAP
16194152|NCT01440634|Other|Supervised exercise Program|Supervised exercise Program consist of six months of supervised, intermittent track walking. Walking duration will begin at 20 - 30 minutes per session for the first month of the program, and increased by 5 minutes per session per month until a total of 45 minutes of walking per session is reached by the third month. During each exercise session, individuals will be encouraged to walk at a speed of approximately 2 mph until they achieve leg pain or discomfort on walking of moderate severity.Individuals are then allowed to have a brief period of standing or sitting rest to permit symptoms to resolve before they resume exercise.
16194153|NCT01440621|Drug|Modafinil|Tablet Modafinil 100mg (Generic) to be given in 100mg once a day dose, at 8AM daily in the morning, and to be given from Day 1 of Radiation Therapy till the first post treatment follow-up
16194154|NCT01440621|Drug|Pyridoxine|Tablet Pyridoxine 10mg once a day at 8AM daily, from Day one of RT till first post-treatment followup. Tab Pyridoxine 10mg has been chosen as placebo as it resembles Tab Modafinil 100mg in physical appearance, size and shape. Tab Pyridoxine is unlikely to affect Cancer Related Fatigue on its own as all patients on RT are already on multivitamin supplements as per our institutional guidelines.
16194155|NCT01440608|Drug|Albendazole|Pill form, to be given once, 200 mg dosage for children 1-2 years of age, 400 mg dosage for children 2-3 years of age
16194156|NCT01440608|Drug|Placebo|Pill form, 400 mg dose to be given once per day for 14 days in Placebo arm and 13 days in Albendazole arm following one dose of Albendazole.
16194157|NCT01440608|Dietary Supplement|High-dose Zinc|Pill form, equivalent to 20 mg elemental zinc, to be given once per day for 14 days
16194158|NCT01440595|Drug|Grazoprevir|Grazoprevir 100 mg tablets once daily for 12 weeks.
16194159|NCT01440595|Drug|Placebo to Grazoprevir|Placebo to Grazoprevir once daily for 12 weeks
16194160|NCT01440595|Drug|Peginterferon alfa-2b (Peg-IFN)|Peg-IFN weekly subcutaneous injection at 1.5 mcg/kg/week for 12 or 24 weeks
16194161|NCT01440595|Drug|Ribavirin (RBV)|Ribavirin 200 mg capsules twice daily at a dose of 600 mg to 1400 mg based on weight for 12 or 24 weeks
16194162|NCT01440582|Drug|Panobinostat|"Induction Therapy (Part A, 21-day cycles): 10 mg by mouth on Days 1, 3, 5, 8, 10, and 12 for 2 weeks with 1 week of rest at the end of each cycle.
~Induction Therapy (Part B, 28-day cycles): 10 mg by mouth on Days 1, 3, 5, 15, 17, and 19 of every cycle.
~Maintenance dose (Part A, 28-day cycles): Maximum tolerated dose (MTD) from Induction phase on Days 1, 3, 5, 8, 10, and 12 of each cycle.
~Maintenance dose (Part B, 28-day cycles): Maximum tolerated dose (MTD) from Induction phase on Days 1, 3, 5, 15, 17, 19 of each cycle."
16194163|NCT01440582|Drug|Bortezomib|"Induction Therapy (Part A, 21-day cycles): 1.3 mg/m^2 by vein daily on days 1, 4, 8 and 11 of Cycles 1 - 8.
~Induction Therapy (Part B, 28-day cycles): 1.3 mg/m^2 by vein daily on days 1, 8 and 15 of Cycles 1 - 8."
16194164|NCT01440582|Drug|Lenalidomide|"Induction Therapy (Part A, 21-day cycles): 25 mg by mouth daily on days 1-14 of every cycle.
~Induction Therapy (Part B, 28-day cycles): 25 mg by mouth daily on days 1-21 of every cycle.
~Maintenance dose (Parts A and B, 28-day cycles): Last tolerated dose from Induction Phase on Days 1 - 21 of each cycle."
16194165|NCT01440582|Drug|Dexamethasone|"Induction Therapy (Part A, 21-day cycles): 20 mg by mouth daily on Days 1, 2, 4, 5, 8, 9, 11 and 12 of Cycles 1 - 8.
~Induction Therapy (Part B, 28-day cycles): 20 mg by mouth daily on Days 1, 2, 8, 9, 15 and 16 of Cycles 1-8.
~Maintenance dose (Parts A and B, 28-day cycles): Last tolerated dose from Induction Phase on Days 1, 8, 15, 21 of each cycle."
16194168|NCT01440569|Drug|DRV|800 mg (2 x 400 mg tablets) administered orally with food once daily
16194169|NCT01440569|Drug|NRTIs|Participants will receive 2 nucleoside analogue reverse transcriptase inhibitors (NRTIs) selected by the investigator after resistance testing at screening and administered according to prescribing information. NRTIs may include emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF), zidovudine+FTC/TDF, abacavir (ABC)+TDF, ABC+FTC/TDF, ABC+lamivudine (3TC), or didanosine (DDI)+FTC.
16194170|NCT01440543|Procedure|Water immersion insertion AND CO2 insufflation|"room temperature water infused by water pump into the colon just to facilitate scope insertion
~CO2 insufflation by CO2 insufflation system during colonoscope withdrawal and mucosal inspection"
16194171|NCT01440543|Procedure|Water immersion insertion|"room temperature water infused by water pump into the colon just to facilitate scope insertion
~standard room air insufflation during colonoscope withdrawal and mucosal inspection"
16194172|NCT01440543|Procedure|CO2 insufflation|- CO2 insufflation by CO2 insufflation system during both colonoscope insertion and withdrawal
16194173|NCT01440530|Behavioral|Educational Intervention|Following randomization to TIDES (N=117) or usual care (N=49), TIDES group was oriented to the multimedia online intervention including a dosed sequence of learning via email, video, slideshows, food solutions, expert questions and answers, and quizzes.
16194174|NCT01440530|Other|Usual Care|Following randomization to TIDES (N=117) or usual care (N=49), TIDES group was oriented to the multimedia online intervention including a dosed sequence of learning via email, video, slideshows, food solutions, expert questions and answers, and quizzes.
16194175|NCT01440517|Drug|Tc99m-Maraciclatide|Freeze-dried powder Kit for the preparation of Maraciclatide (99mTc) Injection
16194176|NCT01440504|Other|culture ex vivo with exposure to different therapeutic agents alone or in combination.|When tumor resection, tumor specimens of ovarian cancer will be made towards a culture ex vivo with exposure to different therapeutic agents alone or in combination.
16194177|NCT01440491|Other|Physiotherapy exercise|once a day, during 15 minutes, for 12 weeks
16194178|NCT01440478|Drug|LY2140023|Administered orally
16194179|NCT01440478|Drug|Ammonium chloride|Administered orally
16194180|NCT01440478|Drug|Sodium bicarbonate|Administered orally
16194181|NCT01440452|Device|FES Cycling|You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.
16194182|NCT01440452|Device|Cycling without FES|You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. The cycle is configured to work without FES. We will then start the cycle motor. This will cause your legs to cycle. You will do this for 1 hour.
16194183|NCT01440452|Procedure|Lumbar puncture|The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).
16194184|NCT01440452|Behavioral|Mood assessment|"If you do not already have an account, you will be signed up with Mood24/7 (http://www.mood247.com). This is a free service that texts your mobile phone daily asking you to rate your mood on a scale of 1 (low) through 10 (high). We will not monitor your entries during the study but only at the final visit when we will get a printout of the course of your mood during the study. After completion of the study we will assist you in removing us from your Mood24/7 account and we will no longer have access to your mood reports outside of the study period."
16194185|NCT01440439|Drug|Insulin glargine|Use of insulin glargine as basal insulin for treatment of Type 1 Diabetes Mellitus
16194186|NCT01440439|Drug|Insulin detemir|Use of insulin detemir as basal insulin for treatment of Type 1 Diabetes Mellitus
16194187|NCT01440426|Procedure|Autologous connective tissue graft with rotated papilla flap|Subepithelial connective tissue graft harvested from hard palate
16194188|NCT01440426|Device|Collagen matrix construct (Mucograft)|Mucograft Collagen Matrix combined with rotated papilla flap
16194189|NCT01440413|Biological|Blood and tumor sample|"Blood samples will be collected on the first day of the first cycle of chemotherapy (before injection of chemotherapy), on the first day of the third cycle (before injection of chemotherapy), on day of surgery and 6 months after surgery and in case of relapse.
~Tumor samples will be collected on diagnosis, on surgery and on the first day of the third chemotherapy course (optional)."
16194190|NCT01440400|Procedure|Ultrasound guided spinal anesthesia|Using the ultrasound to identify the spinal puncture level, mid-line and the depth of the dura.
16194191|NCT01440387|Biological|FLULAVAL® QUADRIVALENT|Intramuscular injection, 1 dose each in FLULAVAL QUADRIVALENT Adults and FLULAVAL QUADRIVALENT Elderly Groups
16194192|NCT01440374|Drug|eltrombopag|100 mg daily (50 mg for subjects of East Asian heritage), intra-subject dose escalations to a maximum dose of 300 mg (150 mg for subjects of East Asian heritage)
16194193|NCT01440374|Drug|placebo|100 mg matching placebo daily (50 mg for subjects of East Asian heritage), intra-subject dose escalations to a maximum dose of 300 mg matching placebo (150 mg for subjects of East Asian heritage)
16194194|NCT01440361|Drug|Belimumab|10 mg /kg given as an intravenous infusion every 4 weeks for 24 weeks (with an additional dose at Week 2)
16194195|NCT01440361|Drug|Normal saline placebo|Placebo given as an intravenous infusion every 4 weeks for 24 weeks (with an additional dose at Week 2)
16194196|NCT01440348|Procedure|cruciate ligament reconstruction|Multiple cruciate ligament reconstructions with a single Achilles allograft with was divided into two or three strips according to the thickness and length of the allograft.
16194197|NCT01440335|Drug|Oral R,R'-Fenoterol|
16194198|NCT01440335|Drug|Oral Racemic Fenoterol|
16194199|NCT01440322|Device|Lotrafilcon B contact lens with color|Silicone hydrogel contact lens with color
16194200|NCT01440322|Device|Lotrafilcon B contact lens|Silicone hydrogel contact lens
16194201|NCT01440309|Biological|Biological: mesenchymal stem cell|Mesenchymal stem cells,5-50 million/kg, Intravenous infusion, One dosage，whether to give another dosage depending on patients' condition
16194202|NCT01440309|Drug|ursodeoxycholic acid|13-15 mg/kg/day, to the end of the study
16194316|NCT01439386|Procedure|Catheter ablation|CTI ablation only
16194203|NCT01440283|Radiation|Intensity Modulated Radiation Therapy (IMRT)|IMRT delivery will follow current conventional volume-targeting guidelines, however, appropriate application within the abdomen will be determined by ascertaining intra-abdominal organ motion and the potential for reducing normal tissue dose, while simultaneously increasing dose delivered to target tissues, particularly when dose escalation for gross residual disease is required. Concurrent neuro-hormonal tests, cytokine analyses, functional and morphologic imaging will generate novel data describing the acute and chronic effects of radiotherapy within the abdomen.
16194204|NCT01440270|Drug|Neo-adjuvant Erbitux-based chemotherapy|"Name/Substance: Erbitux Formulation: 2 mg/ml or 5 mg/ml Dose: 400 mg/m^2 initial, and then 250 mg/m^2 weekly Route: Intravenous infusion Frequency & treatment mode: Weekly Duration: 6 weeks
~Name/Substance: Docetaxel Formulation: Liquid (20 mg/2 ml) Dose: 75 mg/m^2 Route: Intravenous infusion Frequency & treatment mode: Day 1, every 3 weeks Duration: 2 cycles (6 weeks)
~Name/Substance: Cisplatin Formulation: Powder (30 mg) Dose: 75 mg/m^2 Route: Intravenous infusion Frequency & treatment mode: Day 1, every 3 weeks Duration: 2 cycles (6 weeks)
~Arms: Neo-adjuvant Erbitux-based chemotherapy"
16194205|NCT01440257|Drug|Placebo|Placebo capsules once daily
16194206|NCT01440257|Drug|CCX140-B|CCX140-B capsules once daily (Group B)
16194207|NCT01440244|Procedure|Cervical mediastinoscopy|minimally invasive technique to perform pleural evaluation, pleural biopsy and pleurodesis
16194208|NCT01440231|Drug|Placebo|Matching placebo administered by subcutaneous injection, once weekly
16194209|NCT01440231|Drug|Atacicept|Atacicept 5 mg administered by subcutaneous injection, once weekly
16194210|NCT01440231|Drug|Atacicept|Atacicept 25 mg administered by subcutaneous injection, once weekly
16194211|NCT01440231|Drug|Atacicept|Atacicept 75 mg administered by subcutaneous injection, once weekly
16194212|NCT01440231|Drug|Atacicept|Atacicept 115 mg administered by subcutaneous injection, once weekly
16194213|NCT01440205|Behavioral|Easy list of healthy habits|"The recipient will be prompted to check off yes or no to healthy habits that most people will find fairly easy."
16194214|NCT01440205|Behavioral|Challenging list of healthy habits|"The recipient will be prompted to check off yes or no to healthy habits that most people will find fairly difficult."
16194215|NCT01440205|Behavioral|Control|No check box element
16194216|NCT01440192|Biological|PDA001 (cenplacel-L)|1 unit PDA001 (approximately 200 x 106 cells) IV on Days 1 & 8
16194217|NCT01440179|Drug|SAR3419|Pharmaceutical form: concentrate solution for infusion Route of administration: intravenous
16194218|NCT01440166|Drug|Drug|Single dose oral administration of CAT1004 or placebo-6 to 8 subjects will be treated with CAT-1004 per cohort.
16194219|NCT01440166|Other|Placebo|Single dose oral administration of CAT1004 or placebo- 2 subjects treated with placebo per cohort.
16194220|NCT01440153|Other|Exercise Intervention|Participants from group A receive an active program aiming at improving their cardiovascular endurance, muscular strength and motor control. The level for cardiovascular training is based on the results of the maximal exercise test performed during baseline assessment. The level of training is determined at a level of 70% of the predicted maximal heart rate and was increased every 6 weeks with 5%, ending at 85%. Heart rate will be monitored during the training.
16194221|NCT01440153|Other|Passive Intervention|Participants from group B will receive an alternative program, in which all active parts are replaced by passive interventions. Several education sessions will be given regarding different topics, such as stress management, nutrition, injuries, etc. In addition, also practical sessions well be held to practice massage, passive stretching, taping.
16194222|NCT01440140|Other|Closed-loop|Subcutaneous delivery of Novorapid insulin, dose calculated by control algorithm, based on continuous glucose sensor readings.
16194223|NCT01440140|Other|Conventional insulin pump delivery|Subcutaneous delivery of Novorapid insulin according to usual pump regime
16194224|NCT01440127|Drug|Metformin|Pills will be taken for one week prior to the scheduled surgery or biopsy procedure.
16194225|NCT01440114|Drug|fentanyl|In intervention group patient received fentanyl 1 mcg/kg intravenous 15 minutes before the end of surgery.
16194226|NCT01440114|Drug|NSS|Patient in this group received NSS (0.1ml/kg)intravenous route 15 minutes before the end of surgery.
16194227|NCT01440101|Drug|Natalizumab (BG00002)|
16194228|NCT01440101|Drug|Placebo|
16194229|NCT01440088|Drug|TH-302 in Combination with Doxorubicin|"300 mg/m2 of TH-302 will be administered by IV infusion over 30-60 minutes on Days 1 and 8 of a 21-day cycle.
~Doxorubicin may be delivered as a bolus administration or as a continuous infusion administration; administration schedule must be specified prior to enrollment.
~Doxorubicin bolus administration: 75 mg/m2 administered by bolus injection starting on Day 1 of a 21-day cycle.
~Doxorubicin continuous administration: 75 mg/m2 administered by continuous IV infusion over 48-96 hours starting on Day 1 of a 21-day cycle.
~Doxorubicin administration will start between 2 to 4 hours after completion of the TH-302 infusion when used in combination with TH-302."
16194230|NCT01440088|Drug|Doxorubicin|"Doxorubicin may be delivered as a bolus administration or as a continuous infusion administration; administration schedule must be specified prior to enrollment.
~Doxorubicin bolus administration: 75 mg/m2 administered by bolus injection starting on Day 1 of a 21-day cycle.
~Doxorubicin continuous administration: 75 mg/m2 administered by continuous IV infusion over 48-96 hours starting on Day 1 of a 21-day cycle."
16194231|NCT01440075|Other|Cardiac evaluation|"complete cardiac evaluation with :
~Electrocardiogram Echodoppler Echodoppler with dobutamine stress Carotid Echodoppler Coronary scan Positron emission tomography with adenosine stress Blood test (search for early atherosclerosis marker Genotyping"
16194232|NCT01440062|Drug|Verum arm receiving Vitamin D oil|oil: 20000 IU/g tablet: 400 IU/g every second day
16194233|NCT01440062|Drug|low dose arm receiving neutral oil and 400 IU/g of Vitamin D every second day|neutral oil and a low dose of vitamin D
16194234|NCT01440049|Other|Prospective Observational|this is an observational study non interventional
16194235|NCT01440036|Procedure|Carotid endarterectomy|The removal of atherosclerotic plaque from the carotid artery, by surgery
16194236|NCT01440023|Behavioral|Comprehensive Behavioral Intervention for Tics (CBIT)|CBIT is an 8 session treatment protocol held over 10 weeks. Its core components are implemented across the various therapy sessions. These core components include habit reversal training (HRT), functional assessment/function-based interventions, and a behavioral reward program for the child.
16194317|NCT01439373|Drug|GSK2336805|Active Investigational Drug
16194237|NCT01440023|Behavioral|Computerized Response Inhibition Training|Twice-weekly 45 minute computerized sessions for cognitive training focused on enhancing response inhibition capabilities.
16194238|NCT01440023|Behavioral|Computerized Placebo Cognitive Training|Twice-weekly 45 minute computerized sessions for placebo cognitive training, which has been designed to be irrelevant for response inhibition capabilities.
16194239|NCT01440010|Radiation|IORT with 50 kV x-rays, 20 Gy|Intraoperative radiotherapy with the INTRABEAM System with 20 Gy
16194240|NCT01439997|Drug|Desmopressin|Administration of minirin melt 60 µg: desmopressin (acetate) 60 µg oral lyophilisate.
16194241|NCT01439984|Drug|Clomipramine|Clomipramine 15 mg tablet or placebo tablet on demand for 12 weeks
16194242|NCT01439971|Biological|PF-05280602|0.5 micrograms per kilogram of PF-05280602, IV infusion, single dose
16194243|NCT01439971|Biological|PF-05280602|4.5 micrograms per kilogram of PF-05280602, IV infusion, single dose
16194244|NCT01439971|Biological|PF-05280602|9.0 micrograms per kilogram of PF-05280602, IV infusion, single dose
16194245|NCT01439971|Biological|PF-05280602|18.0 micrograms per kilogram of PF-05280602, IV infusion, single dose
16194246|NCT01439971|Biological|PF-05280602|30.0 micrograms per kilogram of PF-05280602, IV infusion, single dose
16194247|NCT01439958|Drug|Inhalation|Twice daily inhalation for a maximum of three years.
16194248|NCT01439945|Drug|magnesium oxide|Given PO
16194249|NCT01439945|Other|placebo|Given PO
16194250|NCT01439932|Device|algometer|"Pressure algometer (Algometry) - This is an instrument that measures pain threshold (the minimum pressure required to produce pain). The instrument consists of a flat disk size centimeter square attached to pressure transducer and measuring electrodes. The disk is placed vertically on the point of pain and therapist increases the intensity of the pressure until initial pain appears (when sense of pressure becomes sense of pain.) Score is determined by average of three repeated measurements with 30 seconds break between each.
~The algometer allows an objective assessment of pain in addition to LEFS score which is a subjective tool. The algometer test was found to be valid and reliable in repeated measurements (interrater, intrarater) by Andrew A. Fischerin 1987 with healthy people [Andrew 1987]. In another study high reliability was found for averaging between three repeated tests: ICC = 0.91 (CI 0.82; 0.97 95%). [Linda et al 2007]"
16194251|NCT01439919|Drug|SSR411298|"Form: tablet
~Route: oral administration with food"
16194252|NCT01439919|Drug|Placebo (for SSR411298)|"Form: tablet
~Route: oral administration with food"
16194253|NCT01439906|Procedure|Surgical correction of the deformity|"Three different surgical techniques are used:
~lumbar fusion vs thoraco-lumbar fusion
~iliac fixation vs fixation to the sacrum
~posterior + interbody fusion vs posterior interbody fusion"
16194254|NCT01439893|Drug|rhNRG-1|day1~day10:0.6ug/kg/day,10hours per day for vein infusion
16194255|NCT01439893|Drug|Placebo|day1~day10:0.6ug/kg/day,10hours per day for vein infusion
16194256|NCT01439880|Biological|Evolocumab|Administered by subcutaneous injection
16194257|NCT01439880|Other|Standard of care|Standard of care therapy as per local practices. This could include prescribed therapies and/or dietary/exercise regimes
16194258|NCT01439867|Drug|Cinacalcet hydrochloride|Cinacalcet was provided as 5 mg capsules that were opened, and the contents were either sprinkled on soft food or suspended into a sucrose syrup to create a liquid suspension for administration. All doses were administered with food or shortly after a meal at the same time daily.
16194259|NCT01439867|Drug|Standard of Care|Standard of care may have included vitamin D sterols (25 OH vitamin D and/or 1-25 OH vitamin D and its analogs) at the discretion of the investigator.
16194260|NCT01439854|Drug|Dapagliflozin|Treatment arm, 10 mg per day for 2 weeks
16194261|NCT01439854|Drug|Placebo|Patients are treated with placebo
16194262|NCT01439841|Dietary Supplement|Multi-strain probiotic|The product consists of Lactobacillus rhamnosus GG, Lactobacillus acidophilus La-5 and Bifidobacterium animalis subsp. lactis Bb-12 added to fermented skimmed milk
16194263|NCT01439841|Dietary Supplement|Placebo|Fermented and subsequently heat-treated, sterile skimmed milk
16194264|NCT01439828|Drug|N-acetylcystein|Visit 1: Consent signed. Blood and urine analysis. Questionnaires assessing cannabis and tobacco's craving.N-acetylcystein and placebo doses will be increased if craving decreases <25% compared to previous visit.The doses start at 200 mg x 4/24h to 800 mg x 4/24h.Visit 2 to 5: Medication safety and cannabis craving and withdrawal assessment during 4 weeks.
16194265|NCT01439815|Drug|Fluticasone Propionate Nasal Spray|two sprays in each nostril once daily
16194266|NCT01439815|Drug|Saline Nasal Spray|two sprays in each nostril once daily
16194267|NCT01439802|Device|Copper IUD placement at time Cesarean Delivery (Copper T 380A)|Placement of Paragard IUD at time of Cesarean Delivery
16194268|NCT01439789|Drug|rhNRG-1|day1~day10:0.6ug/kg/day,10hours per day for vein infusion
16194269|NCT01439789|Drug|Placebo|day1~day10:0.6ug/kg/day,10hours per day for vein infusion
16194270|NCT01439776|Dietary Supplement|Vit D|800IU/day
16194271|NCT01439750|Drug|Rituximab|375 mg/m2 on day 5, 12, 19, 26 of Cycle1; and day 5 of Cycles 2-6; then every 2 months as maintenenace dose
16194272|NCT01439750|Drug|bortezomib|1.6 mg/m2 day 12, 19, 26 for 3 cycles (28 days). Then beginning with Cycle 4, 1.6/mg/m2 every two weeks (Days 5 and 19; maintenance every other week until toxicity or proression of disease).
16194273|NCT01439750|Drug|Cladribine|Phase I will use 3 dose levels Level 1: caldribine (2-CdA) 3mg/m2 days 1-5; Level 2 caldribine 4mg/m2 days 1-5; Level 3: cladribine 5mg/m2 days 1-5
16194274|NCT01439724|Device|Low Level Laser Therapy- (DMC, São Paulo, Brazil)|Diode laser (DMC,São Paulo, Brazil) InGaAlP (indium phosphide, gallium and aluminum), with 100 mW, 4J/cm ², with an area of 0.24 cm ². The laser was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.
16194275|NCT01439724|Device|Placebo (DMC, São Paulo, Brazil)|The placebo (DMC, São Paulo, Brazil) was daily applied by a dentist and touched the mucosa of the lips, right and left buccal mucosa, left and right lateral tongue border, buccal floor and ventral tongue, totaling nine points per region.Patients in the placebo group received the same treatment during the same time, but in this case the laser tip produced no light.
16194276|NCT01439711|Drug|letrozole|
16194277|NCT01439711|Procedure|MRI|
16194278|NCT01439711|Procedure|conventional surgery|
16194318|NCT01439373|Drug|Pegylated interferon alfa-2a|Standard of Care drug
16194279|NCT01439698|Device|Radio Frequency ablation Probe|Any probe that can conduct radiofrequency ablation within biliary ducts.
16194280|NCT01439672|Dietary Supplement|Mixed meal and insulin challenge|The subject will undergo a mixed meal and insulin challenge as follows: an insulin bolus will be administered and a mixed meal nutrition drink will be consumed over 1-5 minutes. The mixed meal nutrition drink will be selected for that individual to be most likely to raise the glucose levels by 100mg/dl and then return to baseline within a four-hour time period. The nutrition drink will selected from the following types of product lines: Boost products (Nestle Nutrition), Ensure products (Abbott Nutrition), Carnation Instant Breakfast (Nestle Nutrition) or Glucerna (Abbott Nutrition).The pre-meal insulin bolus will be calculated to bring the subject to ~100mg/dl at 1100.
16194281|NCT01439659|Behavioral|Nutritional Counseling|Initial interview and subsequent telephone contact once per week for two months, once every other week for the following two months, and once per month for the remaining two months.
16194282|NCT01439659|Dietary Supplement|Daily Supplements|Two capsules daily in the morning and two capsules daily in the evening of Juice Plus+ in addition to regular meal. Also a beverage, Juice Plus+ Complete (a powder mixture to be added to one cup of fluid) daily in the evening.
16194283|NCT01439646|Other|it is a retrospective study, hence no active intervention|since it is an observational restrospective study hence no active intervention is planned
16194284|NCT01439633|Device|MGH OFDI marking|Imaging of esophagus with OFDI system
16194285|NCT01439620|Device|MGH Optical Frequency Domain Imaging (OFDI)|Imaging of biliary tract with OFDI system using MGH Optical Frequency Domain Imaging (OFDI) System
16194286|NCT01439607|Other|Bone marrow and blood sampling|Bone marrow and blood sampling
16194287|NCT01439594|Device|MGH OFDI Imaging|Imaging of Esophagus with OFDI system
16194288|NCT01439581|Device|Mapping System|Pressure Sensing coverlet on ICU bed and provides real time feedback to assist in effective patient repositioning
16194289|NCT01439581|Device|Non-Mapping System|Standard ICU bed with no mapping system
16194290|NCT01439568|Drug|LY2510924|Administered subcutaneous injection
16194291|NCT01439568|Drug|Carboplatin|Administered intravenously
16194292|NCT01439568|Drug|Etoposide|Administered intravenously
16194293|NCT01439555|Drug|Simvastatin|Simvastatin, 40 mg per day orally
16194294|NCT01439555|Drug|L-Arginine|L-Arginine, 2 Gm four times per day orally;
16194295|NCT01439555|Drug|Tetrahydrobiopterin|Tetrahydrobiopterin 20 mg/kg/day orally
16194296|NCT01439542|Radiation|Stereotactic Body Radiation|"Clinical Target Volume 1 (CTV1): 25 Gy to nodes in 5 fractions, 1 fraction per week
~Clinical Target Volume 2 (CTV2): 40 Gy to prostate and seminal vesicles in 5 fractions, 1 fraction per week"
16194297|NCT01439542|Drug|Luteinizing Hormone Releasing Hormone (LHRH) Agonist|12 months (2x6 month depot) of androgen suppression with LHRH agonist
16194298|NCT01439529|Other|Device programming: nominal|CRT device is programmed to nominal values
16194299|NCT01439529|Other|Programming optimization by QRS|CRT device is programmed by QRS optimization
16194300|NCT01439516|Behavioral|Information|Receipt of PREPARED educational book and video about treatments for end stage renal disease (ESRD)
16194301|NCT01439503|Behavioral|Intervention|"The intervention will consist of an education program. The education program includes providing the ability to enjoy condom use through improved skills related to finding the right fit and feel of condoms, using lubricants that are compatible with latex, negotiating condom use, negotiating sex, and talking with new and existing sex partners about ways to sexualize condoms."
16194302|NCT01439490|Other|FES-PET|Patients undergo FES-PET prior to obtaining histology
16194303|NCT01439464|Device|4 CIS one-touch titanium cage|4 CIS one-touch titanium cage(Solco Biomedical Co. Ltd)
16194304|NCT01439464|Device|Bonglass-SS SSLPB|Bonglass-SS SSLPB(BioAlpha Inc.)
16194305|NCT01439451|Procedure|perturbation training|The experimental and control groups will participate in 3 month training program twice a week 20 minutes each training session
16194306|NCT01439438|Drug|Topiramate coated tablet|Test formulation
16194307|NCT01439438|Drug|Topamax® coated tablet|Reference formulation
16194308|NCT01439425|Behavioral|Weight Loss|The low-calorie diet was designed to achieve a loss of 5-10% of initial body weight. The caloric restriction was 500 kcal below the resting energy expenditure, as evaluated by the Harris-Benedict equation. Intervention group patients received a balanced diet scheme, based on a caloric intake reduction related to BMI and sex (range: 1200-1500 kcal/d for women, 1300-1600 kcal/d for men).
16194309|NCT01439412|Procedure|Acupuncture and standard treatment|"This group will get standard treatment in general practice in accordance with national guidelines, i.e. general advice about activity, prescription of pain relievers (paracetamol, eventually ibuprofen and eventually tramadol), and eventually sick leave.
~In addition they also will receive one treatment of standardized acupuncture procedure during the consultation.
~The acupuncture treatment starts with distal points in the right hand: Lumbar Pain Points (Yaotongxue), strong stimulation for one minute. With the needles still positioned, the patient is instructed to make cautious back and hip movements in 2 minutes. Then the patient lies down on a bench to treat the local points Huatuojiaji (Jiaji) bilaterally in the segments of the L2-L4 for 5 minutes."
16194310|NCT01439412|Other|Standard treatment in general practice|This group will get standard treatment in general practice in accordance with national guidelines, i.e. general advice about activity, prescription of pain relievers (paracetamol, eventually ibuprofen and eventually tramadol), and eventually sick leave.
16194311|NCT01439399|Drug|Lidocaine,|Lidocaine group received an IV bolus of 1.5 mg.kg-1 followed by a continuous infusion of 2 mg.kg-1.h-1 intraoperative and 1.33 mg.kg-1.h-1 for 48 h postoperative.
16194312|NCT01439399|Drug|Ketamine|Ketamine group received a bolus of 0.5 mg.kg-1, then 0.25 mg.kg-1.h-1 followed by 0.1 mg.kg-1.h-1 for the first 24 h, then 0.05 mg.kg-1.h-1 for the next 24 h.
16194313|NCT01439399|Drug|association ketamine-lidocaine|Ketamine-lidocaine group received a bolus of 1.5 mg.kg-1 of lidocaine and 0.5 mg.kg-1 of ketamine, a continuous infusion of 1.3 mg.kg-1.h-1 of lidocaine and 0.17 mg.kg-1.h-1 of ketamine was delivered followed by 0.9 mg.kg-1 of lidocaine with 0.08 mg.kg-1.h-1 of ketamine during 48 h, the dose of ketamine being reduced to 0.04 mg.kg-1.h-1 after the first 24 hours.
16194314|NCT01439399|Drug|Placebo|The control group (C) received an equal volume of saline 0.9 % during 48 h.
16194315|NCT01439386|Procedure|Catheter ablation|PVAI with or without CTI ablation
16194320|NCT01439373|Drug|GSK2336805 Matching Placebo|Placebo of Investigational Drug
16194321|NCT01439360|Biological|Quadrivalent seasonal influenza vaccine(Flu D-QIV) GSK2321138A|Intramuscular injection
16194322|NCT01439360|Biological|Havrix Junior|Intramuscular injection administered to subjects aged 12 months or older
16194323|NCT01439360|Biological|Prevenar 13|Intramuscular injection administered to subjects less than 12 months of age
16194324|NCT01439360|Biological|Varivax/ProVarivax|Intramuscular injection administered to subjects more than 12 months of age
16194325|NCT01439360|Biological|Varilrix|Subcutaneous injection administered to subjects more than 12 months of age
16194326|NCT01439347|Drug|Vincristine Sulfate Liposomes Injection (VSLI)|2.25 mg/m^2 (without any dose cap) as an IV infusion over 60 minutes.
16194327|NCT01439347|Drug|Vincristine Sulfate Injection (VSI)|1.4 mg/m^2 with a 2 mg dose cap as an IV infusion over 10 minutes.
16194328|NCT01439334|Behavioral|MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Online Program Brief|Online prevention program using positive images
16194329|NCT01439334|Behavioral|MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Online Program Extended Length|Online Program Extended Length
16194330|NCT01439334|Behavioral|MB-SBIRT (multiple behavior screening, brief intervention and referral to treatment) Control|Control
16194331|NCT01439321|Biological|Eltrombopag|Switched to Eltrombopag
16194332|NCT01439321|Biological|Romiplostim|Switched to Romiplostim
16194333|NCT01439308|Drug|Placebo|SB-705498 placebo
16194334|NCT01439308|Drug|SB-705498|12mg intranasal SB-705498
16194335|NCT01439282|Drug|eribulin mesylate|Cohort I & II: eribulin mesylate (E7389) 1.4 mg/m2 intravenously over 2 - 5 minutes on Day 1 and Day 8 for 4 cycles
16194336|NCT01439282|Drug|capecitabine|Cohort 1: capecitabine 900 mg/m2 orally twice daily on Days 1 - 14 of a 21-day cycle for 4 cycles Cohort II: fixed dose of 1500 mg oral capecitabine twice daily, 7 days on then 7 days off for 4 cycles
16194337|NCT01439269|Behavioral|Family Nurture Intervention|Family Nurture Intervention is facilitated by specially trained Nurture Specialists. The intervention involves calming interactions between mother and infant in the isolette via odor exchange, firm sustained touch and vocal soothing, through calming interactions during holding and feeding via the Calming Cycle and through family sessions designed to engage the help and support of family members for the mother.
16194338|NCT01439256|Behavioral|Computer Controlled Telephone Counseling|The subjects in the intervention arm receive medication adherence counseling through a computer controlled telephone counseling program
16194339|NCT01439256|Other|Physician information and management recommendations|Treating physicians for those subjects in the intervention arm receive through the medical record system a summary of blood pressure values and adherence data and recommendations.
16194340|NCT01439243|Drug|Donepezil|10 mg Tablet
16194341|NCT01439243|Drug|Aricept®|10 mg Tablet
16194342|NCT01439230|Drug|Donepezil|10 mg Tablet
16194343|NCT01439230|Drug|Aricept®|10 mg Tablet
16194344|NCT01439204|Biological|Abatacept (BMS-188667)|Solution for injection, Intravenous, 750 mg, Single dose, 1 day,
16194345|NCT01439191|Drug|humanized anti-HER2 antibody|Initial dose of 4 mg/kg as an intravenous infusion over 90 minutes then at 2 mg/kg as an intravenous infusion over 30 minutes weekly for 12 weeks. For single agent group, patients with complete response, partial response or stable disease could be treated for 24 weeks.
16194346|NCT01439191|Drug|Vinorelbine|Vinorelbine was administered weekly at a dose of 25 mg/m2 on day 1, 8 and 21 every 4 weeks
16194347|NCT01439178|Drug|Intravitreal Avastin injection|Bevacizumab (1.25 mg in 0.05 ml) (Avastin; Genentech Inc., San Francisco, CA, USA) will be injected through the pars plana at 3.5 mm from the limbus, using 30 gauge needle.
16194348|NCT01439165|Biological|Tetanus Toxoid, Diphtheria Toxoid and Pertussis Vaccine|0.5 mL, Intramuscular
16194349|NCT01439165|Biological|Tetanus and Diphtheria Toxoids Adsorbed For Adult Use|0.5 mL, Intramuscular
16194350|NCT01439152|Drug|BAY94-9343|BAY94-9343 was administered intravenously in this study. The starting dose for this first-in-man study was 0.15 mg/kg administered as a 1 hour infusion every 21 days.
16194351|NCT01439152|Drug|BAY94-9343 (Expansion)|BAY94-9343 was administered intravenously in this study. The dose for this expansion cohort was 5.5mg/kg administered as a 1 hour infusion every 21 days.
16194352|NCT01439152|Drug|BAY94-9343 (1.8 mg/kg)|BAY94-9343 was administered intravenously in this study. The dose for this cohort was 1.8 mg/kg administered as a 1 hour infusion every week for 3 weeks.
16194353|NCT01439152|Drug|BAY94-9343 (2.2 mg/kg)|BAY94-9343 was administered intravenously in this study. The dose for this cohort was 2.2 mg/kg administered as a 1 hour infusion every week for 3 weeks.
16194354|NCT01439126|Drug|clonidine hydrochloride|KAPVAY™ (clonidine hydrochloride) 0.1 mg, 0.2 mg, 0.3 mg, or 0.4 mg from Weeks 11-36
16194355|NCT01439126|Drug|Placebo|KAPVAY™ (clonidine hydrochloride) 0.1 mg, 0.2 mg, or 0.3 mg at Week 11; KAPVAY™ 0.1 mg, KAPVAY™ 0.2 mg, or placebo at Week 12; KAPVAY™ 0.1 mg or placebo at Week 13; placebo from Weeks 14-36
16194356|NCT01439113|Procedure|Ultrasound guided IV placement|The nurse will use the emergency department's ultrasound machine to locate peripheral veins and then cannulate the vessel under ultrasound guidance.
16194357|NCT01439100|Drug|Oxycodone/Naloxone Prolonged Release tablets|
16194358|NCT01439100|Drug|Placebo|Dummy tablet
16194359|NCT01439087|Device|MGH Optical Frequency Domain Imaging (OFDI) System|Imaging of Colonic Polyps with OFDI system
16194360|NCT01439074|Device|Mepilex Ag|Dressing
16194361|NCT01439074|Drug|Silver Sulphadiazine Ag cream|A cream used on burnt areas.
16194362|NCT01439061|Device|Device: easypod™|Saizen (Somatotropin) as per Summary of Product Characteristics administered by easypod™
16194363|NCT01439035|Device|MGH OFDI Imaging|Imaging of Duodenum with OFDI system
16194364|NCT01439022|Behavioral|Exercise Programme|6 months 2 x a week aerobic and anaerobic exercise delivered in community facilities by an exercise professional and supported by a physiotherapist
16194365|NCT01439022|Behavioral|Hand Writing programme|6 months 2 x a week hand writing practice. Performed in the home supported by a physiotherapist (5 support sessions)
16194366|NCT01439009|Drug|Tolvaptan|Once-daily oral administration of one tolvaptan 15 mg tablet in the morning
16196273|NCT01424384|Drug|Plactebo To Match|Neurophysiological testing
16194367|NCT01439009|Drug|Placebo of tolvaptan|Once-daily oral administration of one placebo tablet in the morning
16194368|NCT01438996|Biological|NVGH Vi-CRM197|Vi-CRM197 glycoconjugated vaccine
16194369|NCT01438970|Device|ALFApump system|The device described above will be implanted using general anaesthesia. The device will be programmed according to each patient's individual requirements, setting the daily loss of ascitic fluid needed to maintain a stable body weight.
16194370|NCT01438957|Drug|Dexmedetomidine hydrochloride|Dexmedetomidine 0.2 to 0.7 mcg/kg/hr
16194371|NCT01438957|Drug|Placebo|
16194372|NCT01438944|Drug|Nicabate 21mg transdermal NRT|Nicabate 21mg Transdermal NRT Patch applied daily for 14 days Testing at Baseline, Day 4, Day 14 and 14 days post.
16194373|NCT01438931|Drug|DA-9501|Dexmedetomidine hydrochloride variable dose
16194374|NCT01438931|Drug|placebo|
16194375|NCT01438918|Drug|SD-6010|200 mg tablets once a day for 2 years
16194376|NCT01438918|Drug|SD-6010|50 mg tablets once a day for 2 years
16194377|NCT01438918|Drug|Placebo|Placebo tablets once a day for 2 years
16194378|NCT01438905|Other|Small amplitude (Grade IV) mobilization|The subject will be in a seated position and the therapist will stabilize the distal tibia with one hand and make contact the anterior talus with the opposite hand. Three 60-second anterior to posterior joint mobilizations of the talus (small amplitude at end range; Grade IV) will be applied by the therapist with one minute rest in between sets.
16194379|NCT01438905|Other|High velocity, low amplitude (Grade V) mobilization|The subject will be in a seated position and the therapist will grasp the dorsum of the foot with their fingers. The ankle will be dorsiflexed until the restrictive barrier is reached. A small amplitude, quick thrust at end of range (High velocity, low amplitude; Grade V mobilization/manipulation) will be applied. If joint cavitation is not felt or heard by the therapist or subject the technique will be repeated one additional time.
16194380|NCT01438892|Drug|tDMARDs|Traditional DMARDs for RA
16194381|NCT01438892|Drug|biodmards|Biologic DMARDs
16194382|NCT01438866|Other|Fissure sealant|Preventing dental caries in primary molars by applying fissure sealants and fluoride varnish, and comparing caries preventive effect of sealants with fluoride varnish.
16194383|NCT01438866|Other|Fissure sealants and fluoride varnish|Comparing preventive effect of fissure sealants and fluoride varnish on occlusal surfaces of primary molars
16194384|NCT01438853|Biological|TNX-832|Single intravenous dose of TNX-832 at 0.06, 0.08 or 0.10 mg/kg
16194385|NCT01438853|Drug|Placebo|Single intravenous dose of saline control
16194386|NCT01438840|Drug|Avatrombopag|
16194387|NCT01438840|Drug|Placebo|
16194388|NCT01438840|Drug|Standard of care|"Permitted ITP concomitant background therapies are as follows:
~Corticosteroids and/or azathioprine taken at a stable dose for 4 weeks before randomization;
~Mycophenolate mofetil (MMF) or danazol taken at a stable dose for at least 12 weeks before randomization;
~Cyclosporine A (CsA) (due to the fact that it is a P-glycoprotein-mediated transport [P-gp] inhibitor) is to be avoided unless deemed medically necessary; CsA taken at a stable dose for at least 12 weeks before randomization.
~At the discretion of the investigator, participants will be allowed to use aspirin, other salicylates, or approved adenosine diphosphate (ADP) receptor antagonists, (eg, clopidogrel, prasugrel) during the study once their platelet count had risen.
~Participants treated with proton pump inhibitors (PPIs) and H2 antagonist therapy will receive a stable dose for at least 6 weeks prior to randomization. Treatment with these therapies must have been completed at least 2 weeks prior to randomization."
16194389|NCT01438827|Drug|Avanz Phleum pratense|Suspension for Injection, Every 6 weeks for one year
16194390|NCT01438827|Drug|Placebo|Suspension for Injection, Every 6 weeks for one year
16194391|NCT01438814|Drug|metformin placebo|metformin placebo tablets 500mg
16194392|NCT01438814|Drug|linagliptin placebo|linagliptin placebo tablets 5mg
16194393|NCT01438814|Drug|metformin|metformin tablets 500mg
16194394|NCT01438814|Drug|metformin|metformin tablets 500 mg
16194395|NCT01438814|Drug|linagliptin|linagliptin tablets 5mg
16194396|NCT01438801|Drug|Nutropin [Somatropin (rDNA origin) for injection]|Doses in the diagnostic protocol are 0.7 and 1.4 mg/m2/day, injected by subcutaneous injection at bedtime for 2 weeks, divided by washout periods of preferably 4 weeks (accepted range 4-6 weeks). An additional period of 2 weeks on 2.8 mg/m2/day (after a washout period of 4-6 weeks) will be added if the IGF-I response on either dosage is insufficient (serum IGF-I SDS <0).
16194397|NCT01438788|Other|Low protein diet|Patients will receive a diet with 0.6-0.8 grams of protein/kilogram body weight/day for one year. Bread, biscuits and pasta will be in part substituted with aproteic food.
16194398|NCT01438775|Drug|NX-1207|2.5 mg NX-1207 in 10 mL saline vehicle
16194399|NCT01438762|Behavioral|Patient information and education|All subjects will receive one-to-one patient education delivered by a physiotherapist. The information will be standardized and cover the topics of: why does it hurt: pain management; information of how to reduce physical activity if necessary; how to return slowly to sports; how to cope with knee pain and information of how to increase knee alignment during walking and stair walking. The patients will also receive this information in written form. This information is expected to take approximately 45minutes per patient.
16194400|NCT01438762|Other|Information, education and physiotherapy|"Patients will receive one-to-one patient education delivered by a physiotherapist. The information will be standardized and cover the topics of: why does it hurt: pain management; information of how to reduce physical activity if necessary; how to return slowly to sports; how to cope with knee pain and information of how to increase knee alignment during walking and stair walking. The patients will also receive this information in written form.
~In addition the patients will receive supervised multimodal physiotherapy carried out by a physiotherapist with previous experience in treating adolescents and PFPS and has more than two years of practical experience in these areas. The multimodal physiotherapy intervention will be carried out at school premises right after the end of class."
16194401|NCT01438749|Drug|Placebo|Single dose
16194402|NCT01438749|Drug|RO4917838|Single doses (3 dose levels)
16194403|NCT01438749|Drug|diazepam|Single dose
16194404|NCT01438736|Drug|Desogestrel 75 micrograms POP (Cerazette), Etonogestrel 68 mg implant (Nexplanon)|Desogestrel 75 micrograms POP daily for 3 monts, followed by etonogestrel 68 mg subdermal implant for following 6 months
16194405|NCT01438736|Drug|Etonogestrel 68 mg subdermal implant|Etonogestrel 68 mg subdermal implant for 6 months
16194406|NCT01438723|Drug|Metformin|prior to CAGB surgery 3 day treatment with metformin 500 mg three times a day
16194407|NCT01438723|Drug|Placebo|prior to CABG surgery 3 day treatment with placebo capsules three times a day
16194408|NCT01438710|Drug|Prograf|Oral Prograf or generic tacrolimus doses will be taken b,i,d, consistently in 2 divided doses, once in the morning and once in the evening, to maintain trough level in the range of 3 to 12 ng/mL. Target trough level for the subject will be determined per clinical practice.
16194409|NCT01438710|Drug|LCP-Tacro|LCP-Tacro will be administered orally q.d. in the morning based on a conversion factor from Prograf or generic tacrolimus to LCP-Tacro of 0.7 for non-African American subjects and 0.85 for African American subjects to maintain target trough level of 3 to 12 ng/mL.
16194410|NCT01438697|Behavioral|Internet Intervention|Participants will spend 1-2 hours each week for 9 weeks using the Internet intervention. Users will complete daily sleep diaries as well as interactive tutorials covering the topics of sleep behaviors, sleep thoughts, sleep education, and relapse prevention. As users progress through the program they will receive tailored instructions for how to improve their sleep.
16194411|NCT01438697|Behavioral|Patient Education Website|Participants will be given access to a relevant patient education website. It will contain material addressing the behaviors and symptoms of insomnia.
16194412|NCT01438684|Drug|RPh201|400 microliter s.c. twice a week for 3 months
16194413|NCT01438684|Drug|Saline|400 microliter Saline solution s.c. twice a week for 3 months
16194414|NCT01438671|Procedure|Nintendo Wii Fit|The Nintendo Wii Fit is an accessory for the Nintendo Wii video game system that utilizes a balance board peripheral. The subject stands on the balance board and engages in video games that require weight shifting and balancing in order to interact with the game. This intervention will be administered for 30 minutes, 3 to 5 times per week (as tolerated by subject), for a two week period.
16194415|NCT01438671|Procedure|Traditional balance training|This physical therapy intervention involves gait training, balance education on various surfaces, activities involving limited and changing bases of support, and dynamic interaction with the subject's environment. This intervention will be administered 30 minutes per day, 3 to 5 days per week (by subject's tolerance), for a two week period.
16194416|NCT01438645|Device|Olympus ScopeGuide|ScopeGuide-assisted colonoscopy using Olympus CF-H180DL variable-stiffness colonoscopes equipped with ScopeGuide capabilities. ScopeGuide will provide the endoscopist with a 3-dimensional image on the monitor depicting the shape of the colonoscope inside the patient's body as it moves through the colon.
16194417|NCT01438632|Device|jet injection device|Rapid-acting insulin analogue aspart (Novorapid®) administration by means of a jet injector or a conventional insulin pen in the subcutaneous tissue. Dosage of insulin will be determined by the normal dosage of insulin used by the patient before breakfast.
16194418|NCT01438606|Biological|VSV-Indiana HIV gag vaccine|Administered IM in both deltoids at baseline and Week 8. Dose will vary depending on which group the participant is enrolled in.
16194419|NCT01438606|Biological|Placebo injection (normal saline)|Administered IM in both deltoids at baseline and Week 8.
16194420|NCT01438593|Procedure|Intercerebral implantation of allogenic CD34+ stem cell|Each patient will receive brain implant of approximately 5 million allogenic Umbilical cord blood CD34+ Stem Cell
16194421|NCT01438580|Drug|Warfarin|Patients randomised to receive warfarin were initiated on treatment at the baseline dose of 1.25mg daily and then gradually increase the amount to the target INR range.
16194422|NCT01438580|Drug|aspirin|100mg aspirin was administrated every day
16194423|NCT01438567|Drug|oxycodone/naloxone prolonged release (OXN PR) tablets|Drug: Oxycodone/naloxone prolonged release tablets Arms: OXN PR Dosage: 2x50/25mg daily or 2x60/30mg daily or 2x70/35mg daily or 2x80/40mg daily
16194424|NCT01438567|Drug|oxycodone prolonged release (OxyPR) tablets|Drug: Oxycodone prolonged release tablets Arms: OxyPR Dosage: 2x50mg daily or 2x60mg daily or 2x70mg daily or 2x80mg daily
16194425|NCT01438554|Drug|Pazopanib|
16194426|NCT01438554|Drug|GSK1120212|
16194427|NCT01438541|Device|Window|Dressing
16194428|NCT01438528|Device|easypod ™|Saizen (Somatotropin) as per Summary of Product Characteristics administered by easypod™
16194429|NCT01438515|Drug|Rifampin|600mg po once daily x 7 days
16194430|NCT01438515|Drug|Doxycycline|100mg po twice daily x 7 days
16194431|NCT01438515|Other|2% mupirocin ointment|~ 1cm applied to the anterior nares twice daily for 7 days
16194432|NCT01438515|Other|4% chlorhexidine gluconate|Daily full body wash (including hair) for 7 days
16194433|NCT01438502|Drug|HyperHAES® (hypertonic saline/HES)|After arrival to the operating theatre both study groups will receive an infusion of acetated Ringers solution 4 ml/kg/hour. Additionally both groups for 4 hours will receive 1 ml/kg/hour of a blinded solution. This solution will be either acetated Ringers solution or HyperHAES® (7.2 % NaCl/ 6 % hydroxyethyl-starch (200/0.5)).
16194434|NCT01438489|Biological|Anifrolumab 300 mg|Participants will receive 300 milligram (mg) anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
16194435|NCT01438489|Biological|Anifrolumab 1000 mg|Participants will receive 1000 mg anifrolumab as an intravenous infusion every 4 weeks for 48 weeks.
16194436|NCT01438489|Other|Placebo|Participants will receive placebo matched to anifrolumab intravenous (IV) infusion every 4 weeks for 48 weeks.
16194437|NCT01438476|Procedure|Intravenous Patient-Controlled Analgesia (IVPCA)|Intravenous analgesia delivered prior to surgery, then patient-controlled following surgical procedures.
16194438|NCT01438476|Procedure|Thoracic Epidural Analgesia (TEA)|Thoracic epidurals (needle inserted into the space between the covering of spinal cord and the cord itself) placed preoperatively in either the holding area or in the operating room.
16194439|NCT01438476|Behavioral|Questionnaires|Questions measure how quickly participant recovers from sedation Day 1 through Day 5 after surgery; approximately 20-40 minutes.
16194440|NCT01438476|Behavioral|Pain Assessment|Hourly post surgery rating level of pain on a scale of 0-10.
16194441|NCT01438463|Biological|Placebo|Increasing volumes of placebo, will be administered by subcutaneous injection (starting with 0.05 ml) at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of placebo, are given at 4-weekly intervals.
16194471|NCT01438242|Device|Genecept Assay|Genetic test which analyzes seven pharmacodynamic and three pharmacokinetic genes important in psychiatric disorders
16195473|NCT01430520|Drug|Placebo|Placebo tablets, 1 tablet a day for 7 days, starting on the day of surgery
16194442|NCT01438463|Biological|PURETHAL Mites 6,667 AU/ml|Increasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals.
16194443|NCT01438463|Biological|PURETHAL Mites 20,000 AU/ml|Increasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals.
16194444|NCT01438463|Biological|PURETHAL Mites 50,000 AU/ml|Increasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals.
16194445|NCT01438463|Biological|PURETHAL Mites 100,000 AU/ml|Increasing dosages, corresponding to increasing volumes of drug solution (starting with 0.05 ml), will be administered by subcutaneous injection at weekly intervals till the maintenance dose (0.5 ml) is reached. Subsequently, maintenance dosages, corresponding to 0.5 ml of drug solution, are given at 4-weekly intervals.
16194446|NCT01438450|Drug|Oral|"Capecitabine : 500 mg OD x 1 week 500 mg BD x 1 week 500 mg (2 morning, 1 evening) x 1 week After attaining the max dose of 1500 mg, a cycle of Capecitabine 1500mg every day for 2 weeks and 1 week off to be maintained.
~Thalidomide: 50 mg OD x 1 week 100 mg OD x 1 week 200 mg OD x 1 week, 300 mg OD x 1 week"
16194447|NCT01438450|Other|Supportive|No specific therapy will be given
16194448|NCT01438437|Procedure|PAI|Under local anaesthesia, taking proper aseptic precautions, 40% acetic acid (total dose not exceeding 3 times the diameter of the mass, (not more than 2ml in one sitting), will be injected into the mass through the percutaneous route
16194449|NCT01438437|Procedure|RFA|Under aseptic conditions and local anesthesia, the needle electrode would be introduced percutaneously into the tumor under ultrasound guidance.
16194450|NCT01438424|Drug|Entecavir|Tablets, Oral, 1.0 mg, once daily
16194451|NCT01438424|Drug|Lamivudine|Oral, 100 mg, daily
16194452|NCT01438411|Drug|Cholic Acid|10-15 mg/kg body weight/day supplied in 50 or 250 mg Cholic Acid Capsules
16194453|NCT01438398|Procedure|Submucosal endoscopic myotomy with mucosal flap technique|Submucosal Endoscopy with Mucosal Flap (SEMF) technique involves the following: (1) injecting 0.9 % normal saline solution to create a submucosal cushion, (2) tiny cut is made into the cushion, (3) Balloon will be used to dilate the opening and allow passage of endoscope in the submucosal space, (4) Upon direct visualization of the muscle fibers, the doctor will cut the circular layers of the diseased muscles, and (5) Tiny clips will be used to close the tiny cut made earlier.
16194454|NCT01438398|Procedure|Submucosal Endoscopic Mucosal Flap (SEMF) technique|
16194455|NCT01438385|Procedure|Interventional Endoscopy|Advanced imaging endoscopic or therapeutic endoscopy
16194456|NCT01438372|Drug|Intravenous iron sucrose|Intravenous iron sucrose will be administered on days 1, 7, 14, and 21 using the formula: Total dose: (normal Hb for age - initial Hb)/100 x blood volume (ml) x 3.4 x 1.5. First dose will be infused over 30 minutes, with subsequent doses administered over 15 minutes if no reactions encountered.
16194457|NCT01438372|Drug|Oral ferrous sulfate|Oral ferrous sulfate will be administered at 3 mg/kg/day divided into 2 doses for 28 days. A tablet form of ferrous sulfate (325 mg with 65 mg of elemental iron per tablet) will be used.
16194458|NCT01438359|Drug|PA21 and Furosemide with food|The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Furosemide will be 40 mg/day
16194459|NCT01438359|Drug|No PA21; Furosemide with food|The maximum dosage of Furosemide will be 40 mg/day
16194460|NCT01438359|Drug|PA21 with food and Furosemide 2hrs later|The maximum dose of PA21 will be 15 g/day. The maximum dose of Furosemide will be 40 mg/day
16194461|NCT01438346|Behavioral|Substance Abuse Education|10 weeks of usual care for substance abuse.
16194462|NCT01438346|Behavioral|Mind-body Bridging|Two sessions per week for 10 weeks, besides usual care treatment for substance abuse.
16194463|NCT01438333|Dietary Supplement|lactobacillus brevis tablets|5 tablets a day for 6 weeks
16194464|NCT01438333|Dietary Supplement|PLACEBO|5 tablets a day for 6 weeks
16194465|NCT01438320|Dietary Supplement|Quercetin|Bioflavonoid
16194466|NCT01438307|Drug|Cabazitaxel-XRP6258 (3-week cycle)|Subjects in Schedule A will begin with an initial dose of 20 mg/m2 every 3 weeks as a 1 hour IV infusion. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 25 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual decision from the investigator.
16194467|NCT01438307|Drug|Cabazitaxel-XRP6258 (5-week cycle)|Subjects in Schedule B will begin with an initial dose of 8.4 mg/m2 as a 1 hour IV infusion on days 1, 8, 15, and 22 of a 5-week cycle. If no dose limiting toxicities are experienced after cycle 1, then the dose will be escalated to 10 mg/m2. Treatment with Cabazitaxel-XRP6258 will continue for a total of 6 cycles unless there is evidence of disease progression, intolerable toxicity or withdrawal of consent. Further treatment after 6 cycles of treatment in patients who achieved an objective response or stable disease, and no significant toxicity will be an individual decision from the investigator.
16194468|NCT01438294|Other|Video game group|The training with video game will be done with heart rate monitors with intensity required to achieve 70% of maximum heart rate reached the maximum test for thirty minutes.Will be used Kinect games ( adventure- reflex ridge).
16194469|NCT01438294|Other|Aerobic exercise group|A 10 minutes warm up period was performed on a treadmill at 2 km/h prior to each session. After that, exercise training was performed during 30 minutes beginning at 70% of the maximum effort determined in the maximal exercise testing. Before and after each session, 3 measures of the peak flow were performed in the standing position (AssessTM, USA). There was progression in the training intensity throughout the study: if the patient maintained 2 consecutive exercise sessions without symptoms, exercise intensity was increased by 5% of cardiac frequency by using either treadmill speed or grade as previously described (Mendes et al.2011).
16194470|NCT01438281|Drug|SYL1001|SYL1001 eye drops. topical administration
16194516|NCT01437852|Biological|StrataGraft Skin Tissue|
16194472|NCT01438229|Device|St. Jude Medical renal artery ablation system: RF ablation generator (IBI 1500T11.5) and Renal artery ablation catheter (DS3D001, DS3D002)|Catheter-based RF ablation in renal artery
16194473|NCT01438203|Procedure|Thrust manipulation|Thrust manipulation is a passive procedure which involves a high velocity low amplitude thrust to the spinal region
16194474|NCT01438203|Procedure|Non-thrust manipulation|Non-thrust manipulation involves a low amplitude, low speed mobilization to the targeted region while adjusting the procedure based on patient feedback
16194475|NCT01438190|Drug|Metformin, gonadotropins in step-down regimen|Metformin 850 mg cps, two cps daily for 12 weeks. gonadotropins 75IU f, step-down regimen, starting dose of 225 IU daily.
16194476|NCT01438190|Drug|Placebo, gonadotropins in step-up regimen|Placebo cps, two cps daily. Gonadotropins 75IU f, step-up regimen, starting dose of 75 IU daily.
16194477|NCT01438177|Drug|Velcade|
16194478|NCT01438177|Drug|Cyclophosphamide|
16194479|NCT01438177|Drug|Chloroquine|
16194480|NCT01438151|Drug|Remicade|The first potential for dose augmentation will be at infusion #3 (visit 1 and 2 patients will receive 5 mg/kg). Patients will be assessed at each infusion visit for response defined as a reduction in HBI score by 2 or more points from prior visit (unless in remission; HBI score of 4 or less). Patients with a response will be maintained at the dose where response was achieved. If there is no response to treatment, or flare at any visit (beginning at visit #3), infliximab dose or dosing frequency will be increased in a gradual fashion, up to a maximum of 15 mg/kg every 6 weeks, until response is achieved.
16194481|NCT01438138|Other|diagnostic laboratory biomarker analysis|Correlative studies
16194482|NCT01438125|Other|MF-4181|Surgical procedure will be performed as per the standard of care. Scar halves randomized to treatment with device (MF-4181), opposite side treated per standard of care.
16194483|NCT01438125|Other|Standard surgical wound closure|Surgical procedure will be performed as per the standard of care. Scar halves randomized to treatment with device (MF-4181), opposite side treated per standard of care.
16194484|NCT01438112|Biological|CG0070 Adenovirus Vector|CG0070 adenoviral vector with GM-CSF expression given intravesically 1x10e12 viral particles for each instillations, weekly times six
16194485|NCT01438112|Other|Control Arm: Quadruple Choice|Quadruple Choice Treatment Options: (same as listed above)
16194486|NCT01438086|Drug|mecasermin|Intracoronary bolus
16194487|NCT01438086|Drug|mecasermin|Intracoronary bolus
16194488|NCT01438086|Drug|0.9% sodium chloride injection|Intracoronary bolus
16194489|NCT01438073|Drug|kisspeptin 112-121|24-h continuous intravenous infusion of kisspeptin 112-121 (12.5-40 mcg/kg/h), single intravenous dose of kisspeptin 112-121 (0.313-13.19 mcg/kg)
16194490|NCT01438073|Drug|GnRH|Single intravenous dose of GnRH (2.5-250 ng/kg)
16194491|NCT01438060|Drug|Aripiprazole (BMS-337039)|"Acute Phase: Oral, Tablets (1 and 5 mg), Week 1-2: 2 mg, Week 3-4: 2 - 5 mg, Week 5-6: 2 - 10 mg, Weeks 7-10: 2 - 15 mg, Once daily, 10 weeks
~Extension Phase: Oral, Tablets (1 and 5 mg), Week 11: 2 mg, Weeks 12-13: 2 - 5 mg, Weeks 14-15: 2 - 10 mg, Weeks 16-140: 2 - 15 mg, Once daily, 130 weeks"
16194492|NCT01438060|Drug|Placebo|Acute Phase: Oral, Tablets, 0 mg, Once daily, 10 Weeks
16194493|NCT01438034|Drug|kisspeptin 112-121|0.24 nmol/kg
16194494|NCT01438034|Drug|GnRH|75 ng/kg
16194495|NCT01438021|Other|pharmacological study|Correlative studies
16194496|NCT01438021|Drug|methotrexate|Given intraventricularly
16194497|NCT01438008|Drug|24% sucrose po solution|"CHEO pharmacy department will provide syringes labeled NICU Pain Relief Study containing a maximum of 1 ml dose of a 24% sucrose solution. The maximum amount of the study solution will be administered according to the infant's gestational age and according to the hospital's Sucrose policy. The total amount of the study solution will be divided into a maximum of 5 aliquots and administered throughout the procedure at two minutes prior to the heel lance, immediately prior to the heel lance, and two-minutely intervals until completion of the procedure."
16194498|NCT01438008|Drug|Placebo po|"CHEO pharmacy department will provide syringes labeled NICU Pain Relief Study containing a maximum of 1 ml dose of water (almost identical in color, consistency and odor placebo to the sucrose solution in identical packaging) The total amount of the study solution will be divided into 5 aliquots and administered throughout the procedure at two minutes prior to the heel lance, immediately prior to the heel lance, and two-minutely intervals until completion of the procedure"
16194499|NCT01437995|Drug|Fluticasone/Salmeterol Diskus|Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
16194500|NCT01437995|Drug|Fluticasone/Salmeterol Diskus|Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
16194501|NCT01437995|Drug|Fluticasone Diskus|Fluticasone Diskus alone 250 ug twice daily without Salmeterol
16194502|NCT01437982|Drug|Loteprednol Etabonate|Ocular administration of study drug. at least once within any indication of the label.
16194503|NCT01437982|Drug|Prednisolone Acetate 1% Oph Susp|Ocular administration of study drug. at least once within any indication of the label.
16194504|NCT01437969|Genetic|genotyping and/or sequencing|genotyping and/or sequencing DNA for IL28
16194505|NCT01437943|Drug|Aliskiren|Take 1 tablet (150 mg) by mouth daily for 180 days
16194506|NCT01437943|Drug|Placebo|Take 1 tablet (0 mg) daily for 180 days.
16194507|NCT01437930|Dietary Supplement|n-3 PUFA|"products (sausage, bread rolls, milk beverage, wafers) enriched with Intervention a-c): n-3 rich plant oils/powder
~linseed oil (20g/d)(PPM, Magdeburg)
~echium oil (20g/d) (HARKE Nutrition)
~microalgae powder(12g/d)(HARKE Nutrition)"
16194508|NCT01437917|Other|20% amylose bread|20% amylose bread
16194509|NCT01437917|Dietary Supplement|10% amylose bread|10% amylose bread
16194510|NCT01437917|Dietary Supplement|Carbohydrates|50g of carbohydrates ingested with 400 ml of water
16194511|NCT01437904|Procedure|Outpatient Recovery|Patients go home following Percutaneous nephrolithotomy
16194512|NCT01437904|Procedure|In hospital recovery|Patients are hospitalized following Percutaneous nephrolithotomy
16194513|NCT01437878|Drug|Iloprost|5ug dose of inhaled iloprost (20ug/mL solution) administered 6 to 9 times per day for 4 weeks
16194514|NCT01437878|Drug|Placebo|matching placebo
16194515|NCT01437865|Drug|Gadofosveset contrast agent enhanced MRI Axilla|A MRI of the Axilla will be performed before and after administration of a single IV bolus injection of gadofosveset of an equivalent of 0.03 mmol Gd/kg body weight at an injection speed of 1.5 mL/sec., followed by a saline flush of 25 mL at an injection speed of 1.5 mL/sec.
16194517|NCT01437839|Drug|Apixaban|Period I: 1 x 5 mg Commercial Image Tablet in fasting state(single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period), Period II: 1 x 5 mg Commercial Image Tablet in fed state (single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period)
16194518|NCT01437839|Drug|Apixaban|Period I: 1 x 5 mg Commercial Image Tablet in fed state(single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period), Period II: 1 x 5 mg Commercial Image Tablet in fasting state (single dose on Day 1 only of each Period; subjects stay in clinic for a total of 4 days for each period)
16194519|NCT01437826|Drug|antioxidants|tablets composed of 200 mcg selenium [as l-selenomethionine], 30 mg zinc, 2 mg vitamin A [retinol], 180 mg vitamin C [ascorbic acid] and 30 mg vitamin E [D-α-tocopherol acetate]
16194520|NCT01437826|Drug|placebo|placebo had an identical appearance as intervention
16194521|NCT01437813|Drug|Glimepiride/ Extended release Metformin|One tablet of Glimepiride/metformin extended release (4/850 mg) was administered as a single oral dose. Patients received a high fat diet 30 min before administration.
16194522|NCT01437800|Drug|Glimepiride / Extended release Metformin (4/850 mg).|One tablet of Glimepiride/metformin extended release (4/850 mg) was administered as a single oral dose, to all patient in fasting.
16194523|NCT01437787|Drug|SAR302503|"Pharmaceutical form:capsule
~Route of administration: oral"
16194524|NCT01437787|Drug|Placebo|"Pharmaceutical form:capsule
~Route of administration: oral"
16194525|NCT01437774|Device|thrombectomy (ReStore or Merci)|Each arm will use either ReStore or Merci as the primary thrombectomy device
16194526|NCT01437761|Device|2008 Sorbent System|2008 Sorbent System with dialysate flow rates (Qd) of 400 and 500 ml/min while maintaining a constant blood flow rate (Qb) and constant dialyzer (KoA).
16194527|NCT01437748|Drug|Indacaterol maleate|Dry powder, 300 mcg, only one inhalation with 24 hours duration
16194528|NCT01437748|Drug|Tiotropium bromide|Dry powder, 18 mcg, only one inhalation with 24 hours duration
16194529|NCT01437735|Drug|QAW039|QAW039 po
16194530|NCT01437735|Drug|Montelukast|Montelukast 10 mg po
16194531|NCT01437735|Drug|Placebo|Placebo
16194532|NCT01437722|Drug|1% SPL7013 Gel|vaginal gel
16194533|NCT01437722|Drug|3% SPL7013 Gel|vaginal gel
16194534|NCT01437722|Drug|placebo gel|vaginal gel
16194535|NCT01437709|Biological|Ofatumumab (This arm is closed)|Ofatumumab Day 1 Week 1: 1000 mg, Day 2 week 1: 1000mg. Patients who exhibit a baseline leukocytosis ≥ 20,000 will receive 300 mg of ofatumumab on day 1, week 1. Thereafter, they can receive the 1000 mg dose Ofatumumab Day 1, Weeks 2-4: 1000 mg Will reassess 8-10 weeks after conclusion of treatment with CT CAP, and following this q 12 wks for 2 yrs, then q 6mo until POD or for a maximum of 5 years
16194536|NCT01437709|Other|Ofatumumab + Bendamustine|Ofatumumab day 1 + Bendamustine 90 mg/m2 days 1 & 2 x 6 cycles q 28 days Cycle 1, day 1: Ofatumumab 1000 mg followed by Bendamustine 90 mg/m2. Patients who exhibit a leukocytosis ≥ 20,000 will receive 300 mg of ofatumumab on day 1, week 1. Thereafter, they can receive the 1000 mg dose. Cycle 1, day 2: Ofatumumab 1000mg followed by Bendamustine 90 mg/m2 Cycles 2-6: Ofatumumab 1000 mg day 1, Bendamustine 90 mg/m2 days 1 and 2 Will reassess 4-6 weeks after conclusion of treatment with CT CAP, and following this q 12 wks for 2 yrs, then q 6mo until POD or for a maximum of 5 years
16194537|NCT01437696|Dietary Supplement|Vitamin D|A liquid cholecalciferol at a dosage of 500IU will be added to a specific food and provided to the participants once a day for 24 weeks.
16194538|NCT01437696|Dietary Supplement|Vitamin D|A liquid cholecalciferol at a dosage of 1000IU will be added to a specific food and provided to the participants once a day for 24 weeks.
16194539|NCT01437696|Other|placebo|No liquid cholecalciferol will be added to the food.
16194540|NCT01437670|Drug|solifenacin 5mg, 10mg|solifenacin 5mg, 10mg
16194541|NCT01437657|Drug|Placebo|Matching RO4917523 placebo orally daily, 6 weeks
16194542|NCT01437657|Drug|RO4917523 0.5 mg|0.5 mg orally daily, 6 weeks
16194543|NCT01437657|Drug|RO4917523 1.5 mg|1.5 mg orally daily, 6 weeks
16194544|NCT01437644|Drug|botulinum toxin intramuscular injection|"A single dose of active drug or placebo will be administered immediately prior to surgery.
~The injections will be given to the anaesthetised child before the surgical procedure begins. The surgeon will perform the injections at three muscle groups around each hip: the adductors, hamstrings and iliopsoas muscles. Two units per kilogram will be given at each site. The maximum dose will be 12 units per kilogram or 500 units in total (whichever is the lesser), divided equally between six or three sites. Each active drug vial will contain 100 iu of the Botox preparation. The volume injected will be dependent on the weight of the child. Injections of normal saline will be administered in those children randomised to the placebo."
16194545|NCT01437631|Procedure|prophylactic clip application|prophylactic clip application after colonoscopic polypectomy
16194546|NCT01437618|Drug|FOLFOXIRI plus bevacizumab|"BEVACIZUMAB 5 mg/Kg i.v. over 30', day 1 followed by
~IRINOTECAN 165 mg/sqm i.v. over 1-h, day 1 followed by
~OXALIPLATIN 85 mg/sqm i.v. over 2-h, day 1 concomitantly with
~l-LV 200 mg/sqm i.v. over 2-h, day 1 followed by
~5-FLUOROURACIL 3200 mg/sqm i.v. 48-h continuous infusion, starting on day 1 Cycles repeated every 2 weeks"
16194547|NCT01437605|Drug|MAGE-A3 ASCI injections without Poly IC:LC|MAGE-A3 ASCI injections without Poly IC:LC as outlined in Detailed Description
16194548|NCT01437605|Drug|MAGE-A3 ASCI injections with Poly IC:LC|MAGE-A3 ASCI injections with Poly IC:LC as outlined in Detailed Description
16194549|NCT01437592|Drug|insulin degludec|For each subject, a single dose of NN1250 will be administered subcutaneously (under the skin)
16194550|NCT01437579|Procedure|intratrigonal injection of botulinum toxin|Bladder intratrigonal injection of botulinum toxin during cystoscopy under general anesthesia
16194551|NCT01437579|Procedure|cystoscopy|cystoscopy under general anesthesia
16194552|NCT01437566|Drug|Fulvestrant|Participants will receive fulvestrant 500 mg as 2 IM injections of 250 mg on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent cycle, each cycle of 28 days until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
16194553|NCT01437566|Drug|GDC-0941|Participants will receive GDC-0941 260 mg (Part II) or 340 mg (Part I) QD orally from Day 1 or Day 15 of Cycle 1 until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
16195474|NCT01430507|Drug|Revamilast|Tablet, Low dose, Once daily for 12 weeks
16194554|NCT01437566|Drug|GDC-0941 Matching Placebo|Participants will receive GDC-0941 matching placebo QD orally from Day 1 or Day 15 of Cycle 1 until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
16194555|NCT01437566|Drug|GDC-0980|Participants will receive GDC-0980 30 mg (Part I) QD orally from Day 15 of Cycle 1 until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
16194556|NCT01437566|Drug|GDC-0980 Matching Placebo|Participants will receive GDC-0980 matching placebo QD orally from Day 15 of Cycle 1 until disease progression, intolerable toxicity, elective withdrawal from the study, study completion or termination.
16194557|NCT01437553|Device|iMAP|IVUS and iMAP analysis for acute coronary syndromes
16194558|NCT01437540|Drug|Aclidinium Bromide/Formoterol Fumarate|Inhaled aclidinium bromide 400 μg/formoterol fumarate 12 μg, high dose twice per day
16194559|NCT01437540|Drug|Formoterol Fumarate|Inhaled formoterol fumarate 12 μg, twice per day
16194560|NCT01437527|Behavioral|Anamorphic Micro software|Body image therapy with Anamorphic Micro software
16194561|NCT01437527|Behavioral|therapy as usual|Body image therapy as usual
16194562|NCT01437514|Radiation|preoperative short-course radiotherapy|preoperative RT received a total dose of 25 Gy in five fractions during five consecutive days. The clinical target volume included the primary tumor and the mesentery with vascular supply containing the perirectal, presacral, and internal iliac nodes(up to the S1/S2 junction).The recommended upper border was at the level of the promontory. Radiation treatment was delivered with a three-portal technique.
16194563|NCT01437501|Drug|Broccoli Sprout Extract Beverage|Broccoli Sprout Extract Beverage: 600 micromole glucoraphanin and 40 micromole sulforaphane dissolved in 100 mL dilute pineapple and lime juice daily for 84 days.
16194564|NCT01437501|Drug|placebo beverage|100 mL of dilute pineapple and lime juice daily for 84 days.
16194565|NCT01437488|Drug|Cabazitaxel|"Cycle 1: 20 mg/m2 in 250cc NS via IV on Day 1 every 21 days
~Following cycles: 20 mg/m2 or escalated to 25 mg/m2 or reduced by 5 mg/m2 in 250cc NS via IV on Day 1 every 21 days at investigator's discretion
~Treatment continues until disease progression, intercurrent illness preventing further treatment, unacceptable adverse event(s), patient withdraws from the study, or changes in the patient's condition which render further treatment unacceptable in the judgment of the investigator"
16194566|NCT01437488|Drug|Neulasta|6 mg via SQ on Day 2 (24-48 hours post-cabazitaxel) every 21 days
16194567|NCT01437488|Procedure|CT Scan|CT scan of chest, abdomen, and pelvis to assess disease following every 3rd cycle of treatment (approximately every 9 weeks)
16194568|NCT01437488|Biological|Blood Draw|Approximately 2 tablespoons of blood will be taken to test complete blood count, glucose, hematology, electrolytes, liver function, creatinine clearance, and a chemistry profile. This week be done weekly during the first cycle of treatment
16194569|NCT01437475|Biological|Sci-B-Vac|10 microgram/ml hepatitis B surface antigen, 1 ml given intramuscularly
16194570|NCT01437462|Drug|Sevoflurane|Sevoflurane inhalation anesthesia, sufficient amount to maintain adequate general anesthesia for surgery
16194571|NCT01437462|Drug|Propofol|Propofol intravenous anesthesia, sufficient amount to maintain adequate anesthesia during surgery
16194572|NCT01437449|Drug|Docetaxel|30 mg/m² by intravenous (IV) administration
16194573|NCT01437449|Drug|Cisplatin|30 mg/m² by intravenous (IV) administration
16194574|NCT01437449|Drug|Cetuximab|400 mg/m² by intravenous (IV) administration, thereafter 250 IV
16194575|NCT01437449|Drug|Carboplatin|Area under the free carboplatin plasma concentration versus time curve (AUC)=2 by intravenous (IV) administration
16194576|NCT01437436|Procedure|ventilation tube|ventilation tube insertion
16194577|NCT01437423|Biological|TETRAXIM™: Combined adsorbed diphtheria, tetanus, acellular pertussis and enhanced inactivated polio|0.5 mL, Intramuscular at 2, 4, 6 months (Primary) or at 4 to 6 years (Booster) vaccination
16194578|NCT01437410|Procedure|EUS-FNA|tissue samples were harvested from 116 patients undergoing EUS-FNA of solid masses for cytologic smear and histological analysis.
16194579|NCT01437397|Drug|Aclidinium Bromide/Formoterol Fumarate|Inhaled Aclidinium/formoterol FDC 400/12μg, twice per day
16194580|NCT01437397|Drug|Aclidinium Bromide/Formoterol Fumarate|Inhaled Aclidinium/formoterol FDC 400/6μg, twice per day
16194581|NCT01437397|Drug|Aclidinium Bromide|Inhaled Aclidinium 400 μg, twice per day
16194582|NCT01437397|Drug|Formoterol Fumarate|Inhaled Formoterol 12 μg, twice per day
16194583|NCT01437397|Drug|Placebo|Inhaled dose-matched placebo, twice per day
16194584|NCT01437384|Drug|E5501|20 mg oral dose of E5501; 240 mg once daily oral dose of sustained release verapamil; 400 mg oral dose of cyclosporine
16194585|NCT01437371|Drug|- Angiotensin conversing enzyme inhibitors: enalapril, captopril, lisinopril, ramipril, trandolapril.|The purpose of this study is to determine if there is an interest to optimize HF management in patients over 80 years old. The primary objective is to assess the effect of HF optimized management (guidelines of the European society of Cardiology (ESC) on QOL in aged over 80 year's old at 6 months
16194586|NCT01437358|Other|Epidural analgesia|The purpose of this observational prospective study is to describe the safety and feasibility of this analgesia technique in ICU patients
16194587|NCT01437319|Device|lotrafilcon A|To be used during run-in phase only.
16194588|NCT01437319|Device|comfilcon A|To be assigned at randomization at phase 2 only.
16194589|NCT01437319|Device|balafilcon A|To be assigned at randomization during phase 2 only.
16194590|NCT01437319|Other|etafilcon A|Assigned to Neophytes during Phase I for a 2-week period
16194591|NCT01437306|Drug|Lofexidine HCl|400 mcg (2 x 200 mcg tablets) administered orally as a single dose
16194592|NCT01437293|Drug|L-dopa / carbidopa / entacapone (LCE)|For this trial we propose a target dosage of L-dopa / carbidopa / entacapone of 400 mg L-dopa / 100mg carbidopa / 200 mg entacapone, twice daily.
16194664|NCT01436643|Drug|Fingolimod|Dosage of 0.5 mg per capsule (hard gelatin capsules) was taken p.o. once daily. Fingolimod was supplied in bottles containing 35 capsules each.
16194705|NCT01436370|Biological|Trivalent inactivated influenza vaccine|Inactivated trivalent influenza virus vaccine (Sanofi Pasteur Fluzone® High Dose [60 mcg x 3 strains]), as a single intramuscular dose. 80 and up to 100 subjects. Subjects enrolling between October 2011 and February 2012 will receive the 2011-2012 vaccine and subjects enrolling after July 2012 will receive the 2012-2013 vaccine.
16194593|NCT01437280|Biological|CGTG-102|"VP=virus particle
~Dose Level 1: 3x10^10 VP/injection
~Dose Level 2: 1x10^11 VP/injection
~Dose Level 3: 3x10^11 VP/injection
~Patients will receive 4 administrations of CGTG-102 (on days 1, 4, 8, 15).
~Escalation to the next dose level will occur when the safety of all 4 administrations has been evaluated at day 43 on all patients in the preceding dose level.
~The total dose will be injected into up to 10 tumors injectable by either direct visualization/palpitation and/or ultrasound. Typically, the largest safely injectable tumors are chosen.
~Injections will be performed by a radiologist or other trained physician. Injections will be planned based on the baseline PET-CT: only PET-positive tumors or tumor regions should be injected. Injection needles designed for percutaneous insertion into tissues will be used."
16194594|NCT01437267|Biological|Vi-CRM197 vaccine|
16194595|NCT01437267|Biological|Pneumococcal conjugate vaccine|
16194596|NCT01437267|Biological|Vi Polysaccharide (PS) vaccine|
16194597|NCT01437254|Drug|CPERT|Single 340 MBq CPERT scan in first 10 subjects
16194598|NCT01437254|Drug|GPERT|Single 340 MBq GPERT scan in up to 20 case-matched controls
16194599|NCT01437228|Drug|povidone- iodine solution.|%10 Polivinilpirolidon iyot (Polividon- iyot
16194600|NCT01437228|Drug|placebo|NO İNTERVENTİON
16194601|NCT01437215|Device|Ventana Fenestrated Stent Graft System|Endovascular repair of juxtarenal or pararenal aortic aneurysm
16194602|NCT01437189|Drug|Sertraline|Starting dose 25mg/day for 1 week, then increasing to 50mg/day, add on 50mg each time when the depressive symptoms are not improved, at 2-week intervals. Maximum: 200mg/day. Maintenance: lowest effective dose.
16194603|NCT01437176|Device|new type of intramedullary nail|This is a new fixation treat for intertrochanteric fracture.
16194604|NCT01437176|Device|The intramedullary nail of PFNA|It was used very common in treat with intertrochanteric fracture.
16194605|NCT01437163|Device|TopHat 655 rejuvenation system|TopHat 655 system is to be applied every other day for 16 weeks for a pre-programmed time period
16194606|NCT01437163|Device|Laser and/or Light Hair Rejuvenation System|A red incandescent light source replaces all lasers and light emitting diodes.
16194607|NCT01437150|Device|Anatomical locking plate|This is a new fixation treat for acetabular posterior wall fracture.
16194608|NCT01437150|Procedure|The Reconstructive Plate|Reconstructive plate was used very common in treatment of acetabular fracture.
16194609|NCT01437137|Device|classic-laryngeal mask airway (c-LMA)|Insertion of c-LMA
16194610|NCT01437137|Device|i-gel™|Insertion of I-gel
16194611|NCT01437111|Drug|MK-217A/Alendronate Sodium 70-mg/Vitamin D3 5600 IU Combination Tablet|One combination tablet orally once a week
16194612|NCT01437098|Device|MDT-2111 CoreValve for TAVI|CoreValve Transcatheter Aortic Valve Implantation (TAVI) using the MDT-2111 system.
16194613|NCT01437072|Other|No treatment given|The screening test includes a combination of a risk assessment questionnaire and biochemical tests.
16194614|NCT01437059|Drug|ALN-PCS02|Dose levels between 15 and 400 μg/kg by intravenous (IV) infusion
16194615|NCT01437059|Drug|Sterile Normal Saline (0.9% NaCl)|Calculated volume to match active comparator
16194616|NCT01437046|Drug|Doxazosin|Doxazosin 16mg/day
16194617|NCT01437046|Drug|Placebo|
16194618|NCT01437020|Drug|SCH708980 Anti-IL-10 monoclonal|Participants in Part 1 of the study will receive varying doses (0.3 mg/kg, 1.0 mg/kg, 3.0 mg/kg, or 10.0 mg/kg) of a single IV infusion of SCH708980. Participants in Part 2 of the study will receive a single IV infusion of SCH708980 on Day 1.
16194619|NCT01437020|Drug|AmBisome|Participants in Part 1 of the study will receive a single IV infusion of AmBisome (10 mg/kg) 7 days after they receive SCH708980. Participants in Part 2 of the study will receive varying doses (3.75 mg/kg, 5 mg/kg, or 10 mg/kg) of a single IV infusion of AmBisome on Day 8.
16194620|NCT01437007|Drug|TKM-080301|
16194621|NCT01436994|Procedure|Block and Replace|The primary objective of treatment is to maintain a euthyroid state with TSH and thyroid hormone levels in the local laboratory normal range. Carbimazole is commenced in a dose of 0.75 mg/kg/day (propylthiouracil - for dose see below) with the aim being to completely preventing endogenous thyroxine production. Thyroxine is then added in a low replacement dose as the thyroid hormone levels fall into the lower half of the laboratory normal range. The principle measure of control during the first 6 months will be thyroid hormone levels rather than TSH. Carbimazole is the preferred treatment because of the increased risk of hepatotoxicity with propylthiouracil but patients who are treated with propylthiouracil can also be recruited and randomised. 1mg of carbimazole is approximately equivalent to 10 mg of propylthiouracil.
16194622|NCT01436994|Procedure|Dose Titration|"The primary objective of treatment is to maintain a euthyroid state with TSH and thyroid hormone levels in the local laboratory normal range.
~Carbimazole is commenced in a dose of 0.75 mg/kg/day until thyroid hormone levels fall into the local laboratory normal range. The dose is then reduced to 0.25 mg/kg/day with the intention of maintaining a euthyroid state as reflected by a free thyroxine and TSH within the normal range.
~Most paediatricians in the UK commence thyrotoxic children on carbimazole rather than propylthiouracil. Carbimazole is the preferred treatment because of the increased risk of hepatotoxicity with propylthiouracil but patients who are treated with propylthiouracil can also be recruited and randomised. The guidelines detailed above can be used in the knowledge that 1mg of carbimazole is approximately equivalent to 10 mg of propylthiouracil."
16194623|NCT01436994|Drug|carbimazole|Carbimazole 5mg and 20 mg tablets Administered as a once or twice daily regimen with total daily dose adjusted according to prevailing biochemistry
16194624|NCT01436994|Drug|propylthiouracil|50 mg tablets administered once daily with the dose adjusted according to the prevailing biochemistry
16194625|NCT01436994|Drug|thyroxine|25mcg, 50mcg and 100mcg tabletes administered once daily with the dose adjusted according to the prevailing biochemistry
16194626|NCT01436981|Procedure|CABG|Preparation of artery mammaria interna
16194700|NCT01436396|Biological|Measles, mumps, and rubella vaccine|0.5 mL, subcutaneous at age 13 to 14 months
16194701|NCT01436396|Biological|Pneumococcal Conjugated Vaccine|0.5 mL, intramuscular at age 13 to 14 months
16194702|NCT01436396|Biological|Diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae vaccine|0.5 mL, intramuscular at age 19 to 20 months
16194703|NCT01436396|Biological|Hepatitis A Pediatric Vaccine|0.5 mL, intramuscular at age 13 to 14 months and 25 to 26 months
16194704|NCT01436383|Other|Hypoxic exposure|Hypoxic exposure
16197510|NCT01414595|Other|medical chart review|
16194627|NCT01436968|Biological|Aglatimagene besadenovec + valacyclovir|"Patients will receive three courses of ProstAtak® each consisting of aglatimagene besadenovec injection + oral valacyclovir. AdV-tk injection will be delivered to the prostate via trans-rectal ultrasound guided injection as follows:
~The first injection will be given at least 15 days and not more than 8 weeks before starting radiation.
~The second injection will be 0-3 days before initiation of radiation therapy.
~The third injection will be 15-22 days after the 2nd injection.
~The prodrug, valacyclovir, will be administered at a fixed dose for 14 days after each AdV-tk injection.
~Standard external beam radiation therapy will be delivered to the prostate. Short-term androgen deprivation therapy (maximum of 6 months) is optional but must be decided before enrollment to allow for stratification."
16194628|NCT01436968|Biological|Placebo + valacyclovir|"Patients will receive three courses each consisting of placebo injection + oral valacyclovir. Placebo injection will be delivered to the prostate via trans-rectal ultrasound guided injection as follows:
~The first injection will be given at least 15 days and not more than 8 weeks before starting radiation.
~The second injection will be 0-3 days before initiation of radiation therapy.
~The third injection will be 15-22 days after the 2nd injection.
~The prodrug, valacyclovir, will be administered at a fixed dose for 14 days after each placebo injection.
~Standard external beam radiation therapy will be delivered to the prostate. Short-term androgen deprivation therapy (maximum of 6 months) is optional but must be decided before enrollment to allow for stratification."
16194629|NCT01436955|Drug|Placebo|multiple oral doses
16194630|NCT01436955|Drug|RG1662|Cohorts receiving multiple oral doses
16194631|NCT01436942|Behavioral|Exercise|"The exercise intervention will be carried out at a fitness center with supervision from a physiotherapist.
~A cardiorespiratory and muscle strengthening exercise program following the American College of Sports Medicine (ACSM) recommendations for maintenance and improvement of physical fitness. Cardiorespiratory fitness: two interval sessions (4 x 4 min), one continuous moderate exercise session (40 min) on a treadmill. The muscle strength exercises will consist of: 15-20 repetitions, large muscle groups as thighs, back and abdomen.
~Dose: 12 weeks. Three times a week, 60 minutes."
16194632|NCT01436929|Drug|Silymarin|Silymarin 140mg 1tab bid for 8 weeks
16194633|NCT01436929|Drug|Placebo|Placebo 1tab bid
16194634|NCT01436916|Drug|oral cholecalciferol + life style counselling|oral cholecalciferol 600000 units loading then 60000 units fortnightly for 6months
16194635|NCT01436916|Drug|placebo + life style counselling|Will provide placebo 10 sachets loading and then single sachet fortnightly for 6 months
16194636|NCT01436903|Device|Thermal Balloon Endometrial Ablation|Thermal Balloon Endometrial Ablation for 10 minutes after curettage
16194637|NCT01436890|Drug|Revamilast|Tablet. Low dose, Once daily for 12 weeks
16194638|NCT01436890|Drug|Revamilast|Medium dose, Once daily for 12 weeks
16194639|NCT01436890|Drug|Revamilast|High dose, Once daily for 12 weeks
16194640|NCT01436890|Drug|Placebo|Placebo tablet in triple dummy format, Once daily for 12 weeks
16194641|NCT01436877|Device|Insertion of Temporary Implantable Nitinol Device (TIND)|Subjects will be inserted with the Temporary Implantable Nitinol Device (TIND) to the bladder neck and urethral prostate for 5 days and thereafter the TIND will be withdrawn in the doctor office.
16194642|NCT01436864|Biological|Recombinant Human VEGF Receptor-Fc Fusion Protein|Intravitreal injection of KH902 once per month
16194643|NCT01436851|Biological|Storage mite allergen extracts|Nasal provocation with increasing doses of storage mite allergen extracts
16194644|NCT01436838|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|All patients will be prescribed with Betaseron and be instructed on treatment by their phisicians
16194645|NCT01436825|Drug|Recombinant Factor VIII (Kogenate FS, BAY14-2222)|Prophylactic treatment : 20-40 UI /Kg administered all 2 in 3 days .
16194646|NCT01436812|Procedure|zero end-expiratory pressure|positive end expiratory pressure 0 cm H2O during peumoperitoneum
16194647|NCT01436812|Procedure|positive end expiratory pressure|PEEP 0 cmH2O
16194648|NCT01436799|Drug|propofol|anaesthesia was induced with the effect-site concentration of propofol 5.0 μg ml-1 mainly.
16194649|NCT01436799|Drug|Desflurane|anaesthesia was maintained by desflurane 4-7vol%
16194650|NCT01436799|Drug|alfentanil|administration of alfentanil 10 μg kg-1 for anesthetic induction
16194651|NCT01436799|Drug|Rocuronium|administration of rocuronium 0.6 mg kg-1 for anesthetic induction
16194652|NCT01436786|Other|Guided Imagery|The 12 week intervention consists of a set of 4 GI compact discs (CDs), each 20 minutes in length. Participants will be instructed to listen to the CD once a day in a recommended order for weeks 1-4 and used in any order for weeks 5-12.
16194653|NCT01436747|Drug|Paricalcitol|2 micrograms daily, peroral, 24 weeks
16194654|NCT01436747|Drug|Placebo|2 micrograms daily, peroral, 24 weeks
16194655|NCT01436734|Other|Fasting glycemia|no intervention
16194656|NCT01436734|Other|Hypoglycemia|Insulin induced hypoglycemia
16194657|NCT01436721|Device|Surgicel® absorbable Haemostat|The raw cut surface was covered with Surgicel® absorbable Haemostat or none but was dried by using fine sutures and an argon beam to achieve complete haemostasis.
16194658|NCT01436695|Device|Epicall|The Epicall system is intended for early detection of seizure by monitoring pre-seizure biomarkers.
16194659|NCT01436669|Device|Home Telemonitoring System (The Zodiac, Philips Health care)|Full blood count (FBC) home tele-monitoring system which will allow cancer patients receiving chemotherapy to test their blood count at home (haemoglobin, haematocrit, white cell count and neutrophil count).
16194660|NCT01436656|Drug|LGX818|
16194661|NCT01436643|Drug|Venlafaxine|Venlafaxine starting dose was 75 mg and given once daily for at least 7 days and a maximum of 28 days. Dosage was increased afterwards to the individual final dose given once daily, i.e. after at least 7 days and a maximum of 28 days, patients were titrated to their maximum dose of 150 Mg
16194662|NCT01436643|Drug|Fluoxetine|Fluoxetine starting dose was 20 mg and given once daily for at least 7 days and a maximum of 28 days. Dosage was increased afterwards to the individual final dose given once daily, i.e. after at least 7 days and a maximum of 28 days, patients were titrated to their maximum dose of 40 Mg
16194663|NCT01436643|Drug|Citalopram|Citalopram starting dose was 20 mg and given once daily for at least 7 days and a maximum of 28 days. Dosage was increased afterwards to the individual final dose given once daily, i.e. after at least 7 days and a maximum of 28 days, patients were titrated to their maximum dose of 40 Mg
16199302|NCT01400477|Other|Placebo|Placebo Comparator
16194665|NCT01436630|Other|Step Test and Six Minute Walk.|The 6 Minute Walk Test (6MWT) was conducted in a level corridor 30 meters long and 5 meters wide. Before and after testing were measured O2 saturation (SatO2) and heart rate (HR), respiratory rate (RR), blood pressure (BP), the Double Product (DP), a measure of myocardial oxygen consumption, was calculated as the product of HR and systolic BP, and the sensation of dyspnea and fatigue of the lower limbs using the Borg scale, and performing the record turns traveled, each 30 meters is considered a covered back. To calculate the predicted distance, the investigators use the formula described by American Thoracic Society (ATS) knowing the weight, age and height of participants. The Step Test (ST) was conducted in six minutes for it to be compared to the 6MWT.
16194666|NCT01436617|Other|blood sample|The IgE anti cetuximab test will then be conducted by an ELISA test
16194667|NCT01436604|Other|Cardiac MRI|"The examinations will be conducted on an MRI with a dedicated antenna heart, by a physician with expertise in cardiac MRI.
~After establishing a good quality ECG synchronization, the following sequences are carried out successively:
~Sequences locating anatomical
~T2 black blood (such as ESF)
~rapid sequence of cine-MRI (such as balanced FFE) vertical and horizontal long axis and short axis of the base to the apex
~T1-weighted sequence with inversion recovery for the assessment of possible consequences of cell damage."
16194668|NCT01436578|Drug|Posaconazole oral suspension 40 mg/mL|Posaconazole oral suspension prescribed according to the current local label
16194669|NCT01436565|Drug|MM-121 (SAR256212)|"Pharmaceutical form:solution
~Route of administration: Intravenous"
16194670|NCT01436565|Drug|SAR245408|"Pharmaceutical form:tablet
~Route of administration: oral"
16194671|NCT01436539|Drug|Adefovir Dipivoxil and polyene phosphatidylcholine|Adefovir Dipivoxil 10 mg once daily for 48 weeks plus Polyene phosphatidylcholine (PPC) 456 mg three times per day for 48 weeks
16194672|NCT01436539|Drug|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg once daily for 48 weeks
16194673|NCT01436526|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Single oral dose of rivaroxaban administered under fasting conditions 2*5 mg tablet in first intervention period and 1*10 mg tablet in second intervention period (after washout period)
16194674|NCT01436526|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Single oral dose of rivaroxaban administered under fasting conditions 1*10 mg tablet in first intervention period and 2*5 mg tablet in second intervention period (after washout period)
16194675|NCT01436513|Drug|Premarin reference tablet (fasted)|Premarin reference tablet, single dose, fasted conditions
16194676|NCT01436513|Drug|Premarin new tablet (fasted)|Premarin new tablet, single dose, fasted conditions
16194677|NCT01436513|Drug|Premarin reference tablet (fed)|Premarin reference tablet, single dose, fed conditions
16194678|NCT01436513|Drug|Premarin new tablet (fed)|Premarin new tablet, single dose, fed conditions
16194679|NCT01436500|Drug|Ifetroban Injection|Ifetroban sodium injectable, diluted in sterile water with 5% dextrose
16194680|NCT01436500|Drug|Placebo|Sterile water with 5% Dextrose
16194681|NCT01436487|Biological|MultiStem|single infusion 1-2 days following ischemic stroke
16194682|NCT01436487|Biological|Placebo|single infusion 1-2 days following ischemic stroke
16194683|NCT01436474|Drug|Varenicline|Patients will be randomly assigned to receive either varenicline or placebo for 45 days. Patients assigned to varenicline and are current smokers will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study. Patients assigned to varenicline and are non-smokers will receive 0.5mg by the oral route once a day for 6 days, followed by 0.5mg twice a day for 6 days. After the first 12 days the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline.
16194684|NCT01436474|Drug|Placebo|Patients will be randomly assigned to receive either varenicline or placebo for 45 days. Patients assigned to varenicline and are current smokers will receive 0.5mg by the oral route once a day for 3 days, followed by 0.5mg twice a day for 4 days. After the first week the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study. Patients assigned to varenicline and are non-smokers will receive 0.5mg by the oral route once a day for 6 days, followed by 0.5mg twice a day for 6 days. After the first 12 days the dose will be increased to 1mg twice daily for the remainder of the active treatment period of the study. Patients assigned to placebo will receive identical looking capsules in a dosage schedule similar to varenicline.
16194685|NCT01436448|Drug|Probiotics Lactobacillus Rhamnosus|Probiotics Lactobacillus Rhamnosus (1010 Colony forming Units (CFU)/day)
16194686|NCT01436435|Device|Jetstream Atherectomy System|Atherectomy
16194687|NCT01436422|Biological|TetraVax-DV Vaccine - Admixture TV003|One subcutaneous injection at Day 0 and Day 180 of a live attenuated recombinant TetraVax-DV vaccine, Admixture TV003 (10^3 PFU of rDEN1Δ30, 10^3 PFU of rDEN2/4Δ30(ME), 10^3 PFU of rDEN3Δ30/31-7164, and 10^3 PFU of rDEN4Δ30)
16194688|NCT01436422|Biological|TetraVax-DV Vaccine - Admixture TV005|One subcutaneous injection at Day 0 and Day 180 of a live attenuated recombinant TetraVax-DV vaccine, Admixture TV005 (10^3 PFU of rDEN1Δ30, 10^4 PFU of rDEN2/4Δ30(ME), 10^3 PFU of rDEN3Δ30/31-7164, and 10^3 PFU of rDEN4Δ30)
16194689|NCT01436422|Biological|Placebo|One subcutaneous injection at Day 0 and Day 180 of placebo
16194690|NCT01436409|Other|echography|echography during labor
16194691|NCT01436396|Biological|Live, attenuated dengue serotype 1, 2, 3, and 4 virus|0.5 mL, subcutaneous at age 12, 18, and 24 months
16194692|NCT01436396|Biological|Yellow fever vaccine|0.5 mL subcutaneous in the deltoid at age 12 to 13 months.
16194693|NCT01436396|Biological|Measles, mumps, and rubella (MMR) vaccine|0.5 mL, subcutaneous at age 12 to 13 months.
16194694|NCT01436396|Biological|Pneumococcal Conjugated Vaccine|0.5 mL, intramuscular at age 13 to 14 months
16194695|NCT01436396|Biological|Hepatitis A Pediatric Vaccine|0.5 mL, intramuscular at age 13 to 14 months and 25 to 26 months
16194696|NCT01436396|Biological|Diphtheria, tetanus, pertussis, polio, and Haemophilus influenzae vaccine|0.5 mL, intramuscular at age 19 to 20 months
16194697|NCT01436396|Biological|Live, attenuated dengue serotype 1, 2, 3, and 4 virus|0.5 mL, subcutaneous at age 18 to 19 and 24 to 25 months
16194698|NCT01436396|Biological|Yellow Fever Vaccine|0.5 mL, subcutaneous at age 12 to 13 months
16194699|NCT01436396|Biological|Placebo (NaCl)|0.5 mL, subcutaneous at age 12 to 13 months
16194706|NCT01436370|Biological|Trivalent inactivated influenza vaccine|Inactivated trivalent influenza virus vaccine (Sanofi Pasteur Fluzone® [15 mcg x 3 strains]), as a single intramuscular dose. 80 and up to 100 subjects. Subjects enrolling between October 2011 and February 2012 will receive the 2011-2012 vaccine and subjects enrolling after July 2012 will receive the 2012-2013 vaccine.
16194707|NCT01436357|Biological|AdCh3NSmut1|Stages I and II: Receive AdCh3NSmut1 at 2.5 x 10^10 total virus particles (vp)/dose, intramuscularly on day 0.
16194708|NCT01436357|Biological|MVA-NSmut|Stages I and II: 1 dose of MVA-NSmut at the dosage 1.8 x10^8 plaque forming units (pfu) intramuscularly on day 56.
16194709|NCT01436357|Other|Placebo|Stages I and II: Two doses of placebo intramuscularly, 1 at day 0 and 1 at day 56.
16194710|NCT01436331|Other|Treatment As Usual (TAU)|Services participating in the trial are routine public Community Mental Health Centres (CMHCs), which operate within the Italian National Health Service. Multi-disciplinary teams operating these CMHCs provide a wide range of integrated programmes, including inpatient care, day care, rehabilitation, outpatient care, home visits, 24-hour emergency services, and residential facilities. Standard care for FEP patients generally consists of personalized outpatient psychopharmacological treatment, combined with non-specific supportive clinical management at the CMHC level. Family interventions generally consist of non-specific informal support/educational sessions. Both specialized individual psychotherapeutic interventions for patients (included CBT) and specialized psycho-educational or cognitive-oriented family interventions are usually not provided, due to lack of trained professionals.
16194711|NCT01436331|Behavioral|TAU+CBT for pts+Family Intervention+CM.|The experimental treatment package is administered by the CMHC staff, after training and with ongoing supervision by experts. Cognitive-behavioural therapy (CBT) is based on the model developed by Kuipers in 1998 and Garety in 2008. A total of 20-30 CBT sessions per patient will be delivered, with weekly sessions during months 1-3 and fortnightly over the following 6 months. Family Intervention is based on the model proposed by Leff in 1982 and further developed by Kuipers in 2002. It includes a total of 10-15 sessions with each individual family: 6 in months 1-3, and at least 1 session/month in the 6 months afterwards. Every patient/family will have a dedicated Case Manager, who will coordinate all planned interventions. Specific training programs have been developed, with assessment of the staff competence. Detailed Manuals based on international standards have been developed and will be used. Fidelity will be measured at the end of the trial.
16194712|NCT01436305|Drug|Alemtuzumab|Induction therapy. Group 1 and 2 study therapy regimens include induction with alemtuzumab, administered as a single intravenous dose intra-operatively over a period of 2 hours.
16194713|NCT01436305|Drug|MMF|"All treatment groups (e.g., Group 1, 2 and 3): Administered at a target dose of 1000 mg by mouth twice daily beginning on the day of surgery or post operative day 1 and adjusted as clinically warranted.
~Note: Myfortic® (mycophenolate sodium) may be used as a replacement for MMF, at a dose of 720 mg taken by mouth twice daily."
16194714|NCT01436305|Biological|Basiliximab|Induction therapy. Group 3 study therapy regimen includes induction with basiliximab, administered in two doses: 1 dose administered within 2 hours prior to transplantation surgery and the 2nd dose 4 days after transplantation (unless held due to contraindication[s])
16194715|NCT01436305|Drug|Short-term Tac|Short-term (3 months)
16194716|NCT01436305|Drug|tacrolimus|maintenance
16194717|NCT01436305|Biological|Belatacept|maintenance
16194718|NCT01436305|Drug|methylprednisolone|All study treatment groups: administration started on the day of transplant and tapered over a 4 day course.
16194719|NCT01436292|Drug|5% human albumin solution (HAS)|"Patient will receive 5% HAS daily for the first 7 days of stay in ICU according to their albumin level:
~≥ 30 gr/L: albumin will not be administered; 25 - 29.9 gr/L: 25 g of 5% HAS; 20 - 24.9 gr/L: 50 g 5% HAS; 15 - 19.9 gr/L: 75 g of 5% HAS; 10 - 14.9 gr/L: 100 g of 5% HAS; < 10 gr/L: 150 g of 5% HAS."
16194720|NCT01436279|Drug|Mifepristone|200 mg po 20-24 hours prior to the procedure
16194721|NCT01436279|Device|osmotic dilators|osmotic dilators placed in the cervix 20-24 hours prior to the procedure
16194722|NCT01436266|Drug|Misoprostol|400 mcg buccally 2 hours prior to procedure
16194723|NCT01436266|Other|Folic acid|2mg buccally 2 hours prior to procedure
16194724|NCT01436253|Behavioral|Lifestyle Changes|Diet, increased physical activity, and weight reduction as per European Guidelines on the Management of Hypercholesterolemia accepted by the Croatian Society of Cardiology were encouraged in addition to pharmacological measures at the discretion of the treating physician.
16194725|NCT01436253|Drug|Hypolipemics|Pharmacological measures at the discretion of the treating physician and in accordance with the respective authorized label and European Guidelines on the Management of Hypercholesterolemia accepted by the Croatian Society of Cardiology.
16194726|NCT01436240|Behavioral|questionnaire administration followed by cognitive interviews|Each cognitive interviewing procedure will include two parts. Participants will first be asked to independently complete a series of PRO-CTCAE symptom items in a Patient Questionnaire. Following completion by the participant of the Patient Questionnaire containing PRO-CTCAE items, the bilingual interviewer will query participants regarding item comprehension, relevance, inclusiveness, cultural appropriateness, and cognitive processes used to generate responses, via a semi-scripted cognitive debriefing interview developed to assure consistency across interviews.
16194729|NCT01436214|Drug|APC-100|Daily oral, dose escalation, 28-day cycle(s)
16194730|NCT01436201|Drug|Digoxin|Administered orally
16194731|NCT01436201|Biological|Dulaglutide|Administered as subcutaneous injection
16194732|NCT01436188|Procedure|Standard CSR sampling procedure|standard frequent CSF sampling procedure for 36 hours
16194733|NCT01436188|Procedure|Alternate frequency CSR sampling procedure|an alternative frequency of CSF sampling procedure for 36 hours
16194734|NCT01436188|Procedure|Standard frequent CSR sampling procedure with 800 mg ibuprofen|standard frequent CSF sampling procedure on Day 1 for 36 hours with 800 mg Ibuprofen administered on Day 1
16194735|NCT01436188|Procedure|Standard CSR sampling procedure|standard frequent CSF sampling procedure for 36 hours.
16194736|NCT01436188|Procedure|Alternative lower frequency CSR sampling procedure|an alternative lower frequency of CSF sampling procedure in comparison to Cohort 1 for 36 hours
16194860|NCT01435265|Behavioral|Standard nurse education|Standard-of-care education from a dermatology nurse on the proper use of adalimumab
16194737|NCT01436175|Drug|SPD489 (Lisdexamfetamine dimesylate) + Antidepressant|SPD489 20mg, 30mg, 50mg, or 70mg + Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily for 52 weeks
16194738|NCT01436162|Drug|Antidepressant + SPD489 (Lisdexamfetamine dimesylate )|Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + SPD489 (oral, 20, 30, 50 or 70 mg, once daily) for 8 weeks
16194739|NCT01436162|Drug|Antidepressant + Placebo|Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks
16194740|NCT01436149|Drug|SPD489 (Lisdexamfetamine dimesylate )|Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + SPD489 (oral, 20, 30, 50 or 70 mg, once daily) for 8 weeks
16194741|NCT01436149|Drug|Placebo|Antidepressant (either escitalopram oxalate, sertraline hydrochloride, venlafaxine hydrochloride extended release or duloxetine hydrochloride) oral, once daily + Placebo (oral, once daily) for 8 weeks
16194742|NCT01436136|Other|Control|GPs managing matched control patients allocated usual care will be unaware of the details of the intervention arm and asked to apply their usual pattern of patient visits and treatment strategies to achieve optimal reduction of CVD risk.
16194743|NCT01436136|Other|Intervention Group|Patients randomised to the intervention group will follow an intensive 52 week period using a clinical protocol aimed to manage CVD risk in HIV individuals with the use of regular visits to a nurse led CVD risk management clinic, within a multi disciplinary approach to care with the involvement of treating physicians, nurses, dieticians, smoking cessation advisors and an exercise physiologist or personal trainer with the aim to reach their individualised CVD risk target.
16194744|NCT01436123|Other|Stenting and micro-infusion of NP|Step 1 - IVUS, OCT-guided put in everolimus-eluting (drug-eluting-DES) stent + intravascular ultrasound (IVUS) mapping + harvesting stem cells with mesenchymal phenotype; Step 2 - culturing of stem cells in medium by gold nanoparticles with silica-iron oxide shells; Step 3 - micro-infusion of stem cells bearing NP into the lesion; Step 4 - detonation of nanoshells after migration of stem cells with NPs inside (until 7-10 days after transplantation). We expect 'melting' and 'burning' effects of PPTT, beneficial effects of bioactive products of stem cells lysis + benefits from further migration of stem cells from patch into the plaque
16194745|NCT01436123|Device|Implantation of everolimus-eluting stent|Put stent in ischemia-related coronary artery by indications for PCI
16194746|NCT01436110|Drug|Fluticasone furoate 50mcg|Once daily inhalation powder via Novel Dry Powder Inhaler
16194747|NCT01436110|Drug|Fluticasone propionate 100mcg|Twice daily inhalation powder via DISKUS/ACCUHALER
16194748|NCT01436110|Drug|Placebo|Inhalation powder via Novel Dry Powder Inhaler and DISKUS?ACCUHALER
16194749|NCT01436097|Behavioral|Information provision intervention|Participant will have access to weekly data showing how much produce they are purchasing. No incentives will be given under this arm. They will also receiving information on weekly purchases, online resources, and weekly reminders on eating healthy.
16194750|NCT01436097|Behavioral|information provision + flat incentive|Participants will earn back 15% of what they spent on groceries for the week if they spend at least 15% of their total grocery budget on fresh produce in addition to receiving the same treatment as the IP arm. They will also receiving information on weekly purchases, online resources, and weekly reminders on eating healthy.
16194751|NCT01436097|Behavioral|Information provision + tiered incentive|In addition to receiving information on weekly purchases, online resources, and weekly reminders on eating healthy the participants assigned to the IP + tiered incentive group would earn back increasing percentages of their grocery spending for meeting increasing targets of produce consumption.
16194752|NCT01436097|Behavioral|Usual Care|Participants will have access through the Way to Health portal to web-based educational materials and recipes related to healthy eating. They will be informed they will receive up to $50 in reimbursements for completing the surveys that are part of the Way To Eat program as follows: $20 for completing the intake questionnaire and weigh-in and $30 reimbursements for completing the exit questionnaire and weigh-in.
16194753|NCT01436084|Drug|SB1518|400 mg taken orally, once daily without regard of food, 28 day cycle.
16194754|NCT01436071|Drug|Fluticasone furoate 50mcg|Inhalation powder delivered by Novel Dry Powder Inhaler
16194755|NCT01436071|Drug|Placebo|Inhalation powder delivered by Novel Dry Powder Inhaler
16194756|NCT01436058|Biological|mesenchymal stem cell|intraarticular injection of mesenchymal stem cell in patients with ankle joint osteoarthritis
16194757|NCT01436045|Drug|Insulin glulisine|Single treatment, 20 IU/Intranasal (.1ml/10 units Intranasally in each nostril)
16194758|NCT01436045|Drug|Saline|Single treatment,(saline) 20 IU/Intranasal (.1ml/10units intranasally in each nostril)
16194759|NCT01436032|Drug|N1539|IV
16194760|NCT01436032|Drug|N1539|IV
16194761|NCT01436032|Drug|N1539|IV
16194762|NCT01436032|Drug|Ketorolac Tromethamine|IV
16194763|NCT01436032|Drug|Placebo|IV
16194764|NCT01435993|Drug|GSK1223249|Intravenous infusion
16194765|NCT01435993|Other|Saline placebo|placebo intravenous infusion
16194766|NCT01435980|Procedure|Gastric Bypass|basal treatment and Gastric Bypass
16194767|NCT01435980|Drug|Exenatide|basal treatment and Exenatide
16194768|NCT01435967|Other|Data collection|Data collected when only the lyophilised formulation of Rotarix was in use (which is considered as baseline) will be specifically compared to data collected post the introduction of the liquid formulation. The results will also be compared to available vaccine coverage data for those rotavirus vaccines being used in Belgium.
16194769|NCT01435954|Drug|Early combination therapy|If index drug was an alpha-blocker (AB) (alfuzosin, doxazosin, tamsulosin, or terazosin), a pharmacy claims for a 5-alpha reductase inhibitor (5ARI) (dutasteride, finasteride) on or within 30 days after the index date or if index drug was 5ARI, fill for an AB on or within 30 days after the index date
16194770|NCT01435954|Drug|Delayed combination therapy|If index drug was an AB (alfuzosin, doxazosin, tamsulosin, or terazosin), a pharmacy claim for a 5ARI (dutasteride, finasteride) more than 30 days but less than or equal to 180 days of the index date
16194898|NCT01435044|Drug|GS-0938|GS-0938 300 mg (3 × 100 mg tablets) administered orally once daily
16194771|NCT01435941|Drug|Non-steroidal anti-inflammatory drug (NSAID)|Participants who self-report that they have treated headaches with any drug in the non-steroidal anti-inflammatory drug (NSAID) class
16194772|NCT01435941|Drug|Triptan|Participants who self-report that they have treated headaches with any drug in the NSAID class and any drug in the triptan class including naratriptan, sumatriptan, rizatriptan, frovatriptan, almotriptan, eletriptan, and zolmitriptan
16194773|NCT01435928|Drug|Lurasidone|Lurasidone 40 and 80 mg, once daily in the evening with a meal or 30 minutes after eating
16194774|NCT01435928|Drug|Matching Placebo|Matching placebo once daily in the evening with a meal or 30 minutes after eating
16194775|NCT01435915|Drug|Ropinirole|"Ropinirole 2 milligrams once daily prolonged release tablet will be given at 24-hour intervals in the morning.
~Single and repeat dose treatment periods will be separated by 7 days of washout period."
16194776|NCT01435902|Drug|Fluticasone Furoate/Vilanterol Inhalation Powder|Fluticasone furoate/Vilanterol inhalation powder inhaled orally once daily for 4 weeks
16194777|NCT01435902|Drug|Fluticasone Propionate Inhalation Powder|Fluticasone propionate inhalation powder inhaled orally twice daily for 4 weeks
16194778|NCT01435876|Procedure|Post exercise Surgery|ORTHOPTICS/MINUS LENS THERAPY
16194779|NCT01435876|Procedure|Orthoptics|MINUS LENS THERAPY/ ORTHOPTICS
16194780|NCT01435876|Procedure|Postop orthoptics|ORTHOPTICS/MINUS LENS THERAPY
16194781|NCT01435876|Procedure|Post exercises surgery|UNIOCULAR/BINOCULAR RECESSION/RESECTION
16194782|NCT01435863|Drug|SP-02L (darinaparsin for injection)|Cohort 1: Darinaparsin 200 mg/m2 for 5 consecutive days every 28 days (5 days therapy, 23 days no therapy is one cycle). Subjects may start from Cycle 1 and continue to a maximum of 4 cycles of treatment.
16194783|NCT01435863|Drug|SP-02L (darinaparsin for injection)|Cohort 2: Darinaparsin 300 mg/m2 for 5 consecutive days every 28 days (5 days therapy, 23 days no therapy is one cycle). Subjects may start from Cycle 1 and continue to a maximum of 4 cycles of treatment.
16194784|NCT01435863|Drug|SP-02L (darinaparsin for injection)|Cohort 3: Darinaparsin 300 mg/m2 for 5 consecutive days every 21 days (5 days therapy, 16 days no therapy is one cycle). Subjects may start from Cycle 1 and continue to a maximum of 4 cycles of treatment.
16194785|NCT01435850|Procedure|primary total hip arthroplasty|All patients eligible to the study criteria will be included. A total hip arthroplasty unilateral will be performed.
16194786|NCT01435837|Drug|C2 (200mg of caffeine; 1/2 L of water)|200mg of caffeine (tablet); 1/2 of water
16194787|NCT01435837|Drug|C3(200mg of caffeine; 1 L of water)|Ingestion of 200 mg of caffeine and 1 Liter of water after between pretest and posttest.
16194788|NCT01435837|Drug|C1 (200mg of caffeine, no water)|Ingestion of 200mg of caffeine (tablet); no water ingestion.
16194789|NCT01435837|Drug|Placebo (no caffeine, no water).|No ingestion of caffeine; no ingestion of water between pretest and posttest.
16194790|NCT01435824|Drug|Human milk-dissolved amoxicillin|An amoxicillin suspension bottle containing 5 grams of amoxicillin (powder) will be resuspended in 60 ml of breast milk to have 100mL of a 50mg/mL suspension.
16194791|NCT01435824|Drug|Water-dissolved amoxicillin|An amoxicillin suspension bottle containing 5 grams of amoxicillin (powder) will be resuspended in 60 ml of water to have 100mL of a 50mg/mL suspension.
16194792|NCT01435811|Biological|Norovirus challenge pool (GII.4, CIN-1)|Norovirus challenge pool (GII.4, CIN-1)
16194793|NCT01435798|Drug|Dextromethorphan|0, 25, 50 and 100% of maximum tolerated dose, each administered over a 4 week period
16194794|NCT01435772|Biological|BMN 701|GILT-tagged recombinant human GAA
16194795|NCT01435759|Drug|Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 10 mg|Antidepressant + SPD489 oral, 10 mg, once daily for 8 weeks
16194796|NCT01435759|Drug|Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 30 mg|Antidepressant + SPD489 oral, 30 mg, once daily for 8 weeks
16194797|NCT01435759|Drug|Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 50 mg|Antidepressant + SPD489 oral, 50 mg, once daily for 8 weeks
16194798|NCT01435759|Drug|Antidepressant + SPD489 (Lisdexamfetamine dimesylate) 70 mg|Antidepressant + SPD489 oral, 70 mg, once daily for 8 weeks
16194799|NCT01435759|Drug|Antidepressant + Placebo|oral, once daily for 8 weeks
16194800|NCT01435746|Behavioral|Red blood cell transfusion|The intervention of this trial is the regime of red blood cell transfusion. The control group will receive red blood cell transfusions according to a conservative regime, whereas the experimental group will receive red blood cell transfusion according to a liberal transfusion regime.
16194801|NCT01435720|Biological|SNS01-T|0.05 mg/kg twice weekly x 6 weeks
16194802|NCT01435720|Biological|SNS01-T|0.2 mg/kg twice weekly x 6 weeks
16194803|NCT01435720|Biological|SNS01-T|0.375 mg/kg twice weekly x 6 weeks
16194804|NCT01435720|Biological|SNS01-T|0.0125 mg/kg twice weekly x 6 weeks
16194805|NCT01435707|Other|epidural steroid injection with Triamcinolone 40mg|epidural steroid injection with Triamcinolone 40mg
16194806|NCT01435707|Other|Selective transforaminal epidural block with triamcinolone 20 mg|Selective transforaminal epidural block with triamcinolone 20 mg
16194807|NCT01435707|Other|caudal epidural steroid injection with Triamcinolone 20mg|caudal epidural steroid injection with Triamcinolone 20mg
16194808|NCT01435707|Other|Selective transforaminal epidural block with triamcinolone 40 mg|Selective transforaminal epidural block with triamcinolone 40 mg
16194809|NCT01435694|Behavioral|Lokomat (Hocoma, Switzerland)|
16194810|NCT01435694|Behavioral|Conventional Therapy|
16194811|NCT01435668|Behavioral|Brief Motivational Intervention (BMI)|Patients receive an information leaflet plus a referral to a psychologiste. BMI is provided by the psychologist. BMI consists in a first face-to-face interview (35-45 minutes) plus a telephone interview, at 1 and 2 months. Minors' parents are also invited to attend the BMI session.
16194812|NCT01435668|Behavioral|Simple written advice|Patients receive an information leaflet.
16194813|NCT01435655|Drug|tafamidis|tafamidis meglumine 20 mg QD
16194814|NCT01435642|Other|No treatment given|Subject will fill out a questionnaire when entering the non-interventional study
16194815|NCT01435629|Drug|somatropin|Dosage and administration to be prescribed by the physician as a result of a normal clinical practice.
16194816|NCT01435616|Drug|Glargine|
16194817|NCT01435616|Drug|LY2605541|
16195087|NCT01433575|Drug|RO4917838|10 mg single oral dose
16195088|NCT01433575|Drug|RO4917838|20 mg single oral dose
16194818|NCT01435603|Behavioral|Standard Lifestyle Advice|Standard clinical education is offered routinely by the participant's usual primary care team. Primary care teams receive educational outreach visits and are provided with clinical recommendations for lifestyle and cardiovascular risk factor management. Brief lifestyle advice is delivered by a study Research Assistant at baseline, 6, 12, and 24 months.
16194819|NCT01435603|Behavioral|Advice Plus Lifestyle Intervention|Standard clinical education offered routinely by the participant's usual primary care team. Primary care teams receive educational outreach visits for lifestyle and cardiovascular risk factor management. Brief lifestyle advice delivered by a study research assistant at baseline, 6, 12, and 24 months. AND, participant offered free of charge access to an intensive lifestyle intervention offered in a community setting. Lifestyle interventions are delivered in community settings by lay instructors from community organizations who are centrally trained by the study team.
16194820|NCT01435590|Procedure|Curette v/s endocervical brush|
16194821|NCT01435577|Drug|Tapentadol|30 mg per administration, maximum 12 administrations over 48 hours
16194822|NCT01435577|Drug|Matching Placebo|Maximum 12 administrations over 48 hours
16194823|NCT01435564|Behavioral|Mobile phone|Participants in this group will receive both the pedometer and the mobile-phone based physical activity intervention fot three months.
16194824|NCT01435564|Behavioral|pedometer only|Participants in this group will receive only a pedometer.
16194825|NCT01435551|Other|Hypnotherapy|1 year study,1 hour session per month for 9 months, 3 remaining months evaluation
16194826|NCT01435538|Behavioral|Care pathway.|The intervention group will implement a care pathway for PFF or COPD containing three active components: a formative evaluation of the actual teams' performance, a set of evidence based key interventions and a training in pathway-development.
16194827|NCT01435512|Behavioral|PTSD-Focused CBT for Partner Violence|PTSD-Focused CBT (PFCBT) will consist of 12 2-hour weekly sessions,led by two project therapists. In each session, group members will discuss materials and do assignments to practice skills.
16194828|NCT01435499|Biological|melanoma GVAX|Melanoma GVAX is given as intradermal injections every 28 days x 4 doses. Cohort A will receive 5E7 cells/dose; cohorts B and C will receive 2E8 cells/dose.
16194829|NCT01435499|Drug|Cyclophosphamide|200mg/m2 given as a single dose, intravenously, one day prior to each of the 4 vaccinations to patients in cohort C only
16194830|NCT01435486|Drug|Caffeine citrate|Single stat dose (25 mg per kilogram of body weight) of intravenous caffeine citrate (25mg caffeine citrate equal to 12.5mg caffeine base).
16194831|NCT01435486|Drug|Normal saline|Placebo with an equivalent volume of normal saline.
16194832|NCT01435473|Procedure|Cardiac Surgery|
16194833|NCT01435460|Drug|Loteprednol etabonate 0.2%|1 drop of Alrex 4 times daily (QID) in both eyes at approximately 4 hour intervals for 2 weeks.
16194834|NCT01435460|Drug|Olopatadine 0.1%|1 drop of Patanol 2 times daily (BID)at intervals of 6-8 hours or more for 2 weeks.
16194835|NCT01435447|Drug|FLu-Bu-Cy|Fludarabine at 30mg/m2 daily followed by iv-Busulfan at 3.2mg/kg daily for a total of 4 days from Day-6 to -3 and cyclophosphamide as 60mg/kg daily for 2 days on Day +3 and +4, CSA 3mg/kg starting after D+5.
16194836|NCT01435434|Device|the Sepax is a tool to standardize adult stem cell. Ignite ®ICS injectable scaffold manufactured by Wright Medical Technology.|
16194837|NCT01435408|Other|Conventional primary PCI|Conventional primary PCI in STEMI with implantation of DES.
16194838|NCT01435408|Other|Ischemic postconditioning.|Primary PCI in STEMI with implantation of DES. Following re-opening of the culprit artery mechanical postconditioning with 4 cycles of 30/30 sec. reperfusion/re-occlusion i performed.
16194839|NCT01435408|Other|Deferred stenting in primary PCI.|In STEMI re-opening of the artery with guidewire/thrombectomy/small size balloon inflation DES stenting is postponed for 48 hours.
16194840|NCT01435395|Drug|Temozolomide, bevacizumab and bortezomib|Escalating temozolomide with standard dose bevacizumab and bortezomib
16194841|NCT01435382|Biological|PF-04950615 (RN316)|Dose A - single-dose intravenous infusion
16194842|NCT01435382|Biological|PF-04950615 (RN316)|Dose B - single-dose subcutaneous injection
16194843|NCT01435382|Biological|PF-04950615 (RN316)|Dose C - single-dose subcutaneous injection
16194844|NCT01435382|Biological|PF-04950615 (RN316)|Dose D - single-dose subcutaneous injection
16194845|NCT01435369|Drug|CT-011|The monoclonal antibody, CT-011 is administered intravenously at 2 dosage levels, 1.5mg/kg and 6.0 mg/kg to patients with metastatic melanoma. The study drug will be given every other week for a total of up to 27 study drug infusions for about 12 months.
16194846|NCT01435356|Biological|recMAGE-A3 + AS15 ASCI|5 doses were administered (intramuscular) at 3-week intervals followed by 8 doses administered at 3-month intervals for a total maximum duration of study treatment administration of 27 months
16194847|NCT01435356|Biological|Placebo|5 doses were administered (intramuscular) at 3-week intervals followed by 8 doses administered at 3-month intervals for a total maximum duration of study treatment administration of 27 months
16194848|NCT01435343|Drug|fludarabine|30 mg/m2/day intravenously on days 1 to 4
16194849|NCT01435343|Drug|Idarubicin|10 mg/m2/day intravenously on days 1 to 3
16194850|NCT01435343|Drug|cytarabine|2 g/m2/day intravenously on days 1 to 4
16194851|NCT01435343|Drug|G-CSF|5 μg/kg/day subcutaneously from days 1 to 4
16194852|NCT01435343|Drug|plerixafor|intravenously from days 1 to 4
16194853|NCT01435330|Drug|BVS857|
16194854|NCT01435330|Drug|Placebo|
16194855|NCT01435317|Device|ANM T30 CR®-System|Stimulation for 4-6h/day for a time of 1 year
16194856|NCT01435304|Device|method of returning residual CPB blood ( Hemobag®)|The Hemobag® is a collection reservoir used to facilitate ultrafiltration of the CPB circuit after the patient has been disconnected from CPB).
16194857|NCT01435291|Drug|Advagraf Capsule|"Other Names:
~FK506E
~MR4
~tacrolimus modified/prolonged release Drug: MPA Solution for infusion and per os Other Name: Mycophenolate Mofetil or Mycophenolic Acid Drug: Basiliximab IV infusion Other Name: Simulect Drug: Corticosteroids per os Other Name: Methylprednisolone or equivalent"
16194858|NCT01435291|Drug|Prograf Capsule|"Other Names:
~FK506E
~MR4
~tacrolimus Drug: MPA Solution for infusion and per os Other Name: Mycophenolate Mofetil or Mycophenolic Acid Drug: Basiliximab IV infusion Other Name: Simulect Drug: Corticosteroids per os Other Name: Methylprednisolone or equivalent"
16194859|NCT01435278|Device|Glucosanol|2 tablets taken 3 times a day.
16194861|NCT01435265|Behavioral|Additional nurse education|Additional education from a nurse on the use of adalimumab. This will include discussion of the pre-study evaluation with the subject, design of an Individual Educational Plan based on the pre-study evaluation, and a 30-60 minute educational session with the nurse educator at each study visit. Additional information concerning the benefits of the local support group and National Psoriasis Foundation will be provided. Additional education on self-injection and the opportunity to practice self-injection under the supervision of a nurse will also be provided. Subjects will also receive reminder phone calls to take each scheduled dose.
16194862|NCT01435252|Drug|Cetuximab|Arm A: chemoradiation in combination with concurrent cetuximab Arm B: chemoradiation in combination with concurrent and consolidation cetuximab
16194863|NCT01435239|Device|The cuff inflation by the resting volume|80 patients are randomly allocated into two groups : resting volume group (n=40), half the maximum volume group (n=40). In the resting volume group, the pilot balloon valve is connected to syringe without piston for keeping the valve open to the atmosphere and allowing the pressure within the cuff of LMA to equalize with atmospheric pressure. In the half the maximum volume group, the cuff of LMA is completely emptied and then the cuff is filled with the half the maximum volume.
16194864|NCT01435239|Device|The cuff inflation by the maximum volume|80 patients are randomly allocated into two groups : resting volume group (n=40), half the maximum volume group (n=40). In the resting volume group, the pilot balloon valve is connected to syringe without piston for keeping the valve open to the atmosphere and allowing the pressure within the cuff of LMA to equalize with atmospheric pressure. In the half the maximum volume group, the cuff of LMA is completely emptied and then the cuff is filled with the half the maximum volume.
16194865|NCT01435226|Drug|GS-5885|"Drug: GS-5885 tablet
~GS-5885 tablet, 90 mg, QD"
16194866|NCT01435226|Drug|GS-9451|"Drug: GS-9451 tablet
~GS-9451 tablet, 200 mg QD"
16194867|NCT01435226|Drug|tegobuvir|tegobuvir 30 mg BID
16194868|NCT01435226|Drug|placebo to match tegobuvir|tegobuvir placebo BID
16194869|NCT01435226|Drug|placebo to match RBV|Ribovirin placebo BID
16194870|NCT01435226|Drug|Ribavirin|Ribavirin (Copegus®) BID (1000 mg for subjects weighing < 75 kg and 1200 mg for subjects weighing ≥ 75 kg) divided BID
16194871|NCT01435213|Drug|Atipamezole|Administration of a single dose of 5-150 micrograms of atipamezole as an intravenous infusion
16194872|NCT01435213|Drug|Atomoxetine|A single dose of 1.2 mg/kg of atomoxetine administered orally
16194873|NCT01435213|Drug|Ketamine|A single dose of ketamine (approximately 60 mg) administered as an intravenous infusion
16194874|NCT01435213|Other|Cold pressor test|30-45 min cold pressor test of the foot
16194875|NCT01435213|Drug|Insulin|Insulin administered as an intravenous infusion to induce hypoglycemia
16194876|NCT01435213|Drug|Placebo|A single dose of placebo (capsules) administered orally
16194877|NCT01435200|Drug|Intravenous iron|Intravenous iron 200 mg add in 0.9% Normal saline 100 ml infused within 15 minutes after every cycles of chemotherapy
16194878|NCT01435174|Drug|Ranolazine|A single dose of two oral ranolazine extended release 500 mg tablets
16194879|NCT01435174|Procedure|Pharmacokinetic Blood and Dialysate Sampling|Blood samples collected to assess ranolazine plasma and dialysate concentrations.
16194880|NCT01435174|Procedure|QT Interval|Calculation of a QT interval will be performed throughout subject participation.
16194881|NCT01435161|Drug|Nifedipine,|Nifedipine 30-60mg/day
16194882|NCT01435161|Drug|Telmisartan|Telmisartan 80-160mg/day
16194883|NCT01435148|Procedure|Deep Brain Stimulation, implanted|Deep brain stimulator implanted during neurosurgery. Specific stimulation parameters programmed after surgery as required. After blinded study arms open stimulation of either or both targets.
16194884|NCT01435135|Biological|ALVAC-HIV|1 mL per injection containing 10^6 CCID50/dose administered
16194885|NCT01435135|Biological|AIDSVAX B/E|1 mL per injection (300 ug dose/antigen for a total of 600ug/dose administered)
16194886|NCT01435135|Biological|ALVAC-HIV Placebo|1 ml per injection
16194887|NCT01435135|Biological|AIDSVAX B/E Placebo|1 ml per injection
16194888|NCT01435122|Drug|Axitinib|Axitinib Administration as outlined in Arm description
16194889|NCT01435109|Behavioral|Patient Behavioral Intervention for OA|Patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.
16194890|NCT01435109|Behavioral|Provider Intervention for OA|Primary care providers receive patient-specific osteoarthritis information and treatment recommendations at the point of clinical care.
16194891|NCT01435109|Behavioral|Combined Patient and Provider Interventions for OA|Patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management; primary care providers receive patient-specific osteoarthritis information and treatment recommendations at the point of clinical care.
16194892|NCT01435096|Drug|BN80927|Administered over 30 minutes in the vein with a fixed infusion rate once every 3 weeks. Each patient could participate in a maximum of 10 continuous cycles, equivalent to 30 weeks treatment.
16194893|NCT01435083|Drug|Desmopressin|120 µg, oral lyophilisate, sublingual use
16194894|NCT01435070|Procedure|Kirschner wire fixation|"The wires are passed through the skin over the dorsal aspect of the distal radius and into the bone in order to hold the fracture in the correct (anatomical) position. The size and number of wires, the insertion technique and the configuration of wires will be left entirely to the discretion of the surgeon.
~A plaster cast will be applied at the end of the procedure to supplement the wire fixation as per standard surgical practice. This cast holds the wrist still and is left on until the wires are removed at the follow-up appointment."
16194895|NCT01435070|Procedure|Volar Locking Plate fixation|The locking-plate is applied through an incision over the volar (palm) aspect of the wrist. The surgical approach, the type of plate and the number and configuration of screws will be left to the discretion of the surgeon. The screws in the distal portion of the bone will be fixed-angle, i.e. screwed into the plate, but this is standard technique for use of these plates. The type of proximal screw will be left to the discretion of the surgeon; these may be locking or non-locking screws. The use of a cast will left to the discretion of the surgeon.
16194896|NCT01435057|Procedure|exercise training|comparison of strength versus endurance training (two or three times a week, 60 minutes per training session) over 24 months
16194897|NCT01435044|Drug|Sofosbuvir|Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
16194899|NCT01435044|Drug|RBV|Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
16194900|NCT01435044|Drug|Placebo to match sofosbuvir|Placebo to match sofosbuvir administered orally once daily
16194901|NCT01435044|Drug|Placebo to match GS-0938|Placebo to match GS-0938 administered orally once daily
16194902|NCT01435031|Device|CTO Treatment Device|"Subjects receiving at least 1 of the following for the treatment of CTO:
~XIENCE V® and/or XIENCE nano™ and/or XIENCE PRIME™ LL Everolimus Eluting Coronary Stent
~HT PROGRESS and/or HT PILOT guide wires in recanalization
~MINI-TREK Coronary Dilatation Catheter in predilatation"
16194907|NCT01435005|Other|Moderate Volume|Moderate volume (150 minutes per week) aerobic exercise
16194908|NCT01435005|Other|High Volume|Participate in one-year high volume (300 minutes per week)aerobic exercise.
16194909|NCT01434966|Other|Lumbopelvic Manipulation|The lumbopelvic joint manipulation (Grade V mobilization) will be performed on the ipsilateral side of the test limb. The participant will be passively side-bent towards and rotated away from the selected lumbopelvic region which is followed by the delivery of a posterior/inferior force through the opposite anterior superior iliac spine. If a cavitation is not heard or felt by the patient or clinician, the technique will be repeated. If the second attempt does not produce cavitation the procedure will be repeated on the contralateral side using similar methods. If cavitation is not heard or felt by the participant or clinician following the second attempt on the contralateral side, the participant will proceed with the assessment of quadriceps strength and activation as usual.
16194910|NCT01434966|Other|TENS- Spine|The TENS electrodes will be applied lateral to L1 and L2 and lateral to S5 and S1. The TENS unit will be set to deliver a continuous TENS biphasic pulsatile current at 150 Hz, with a phase duration of 150 microseconds. The TENS unit will be worn during all exercise testing and for the first 30 minutes of quadriceps force output and activation testing. After the 30 minute post-intervention measures (Post30) are obtained, the TENS unit will be turned off.
16194911|NCT01434966|Other|TENS- Knee|The TENS electrodes will be applied on the medial and lateral superior, as well as the medial and lateral inferior, borders of the patella. Care will be taken not to place TENS electrodes on the quadriceps muscles or muscles of the anterior leg. The TENS unit will be set to deliver a continuous TENS biphasic pulsatile current at 150 Hz, with a phase duration of 150 microseconds. The TENS unit will be worn during all exercise testing and for the first 30 minutes of quadriceps force output and activation testing. After the 30 minute post-intervention measures (Post30) are obtained, the TENS unit will be turned off.
16194912|NCT01434953|Behavioral|Labeled prehypertension|A study physician informs subjects of their blood pressure level. Subjects are told they have prehypertension and are informed of the associated health risks.
16194913|NCT01434953|Behavioral|Unlabeled prehypertension|"A study physician informs subjects of their blood pressure level. The term prehypertension is not used and associated health risks are not discussed."
16194914|NCT01434940|Other|Eye movements will be recorded using video-oculography techniques based on both the corneal reflection principle and an infra-red light beam|. The system named H6-HSCN by Applied Science Laboratories (ASL®) helps keep the patient's head fixed on a support, important for the elderly population. This system allows to capture data with good temporal resolution (sampling at 360Hz) and good spatial resolution (accuracy of 0.1° of visual angle) at a distance of about 70 cm from the screen test with a visual angle of 32.6°. Results will be processed with ASL Result Software.
16194915|NCT01434927|Procedure|Unsedated colonoscopy|Patients were offered to undergo colonoscopy without routine premedication
16194916|NCT01434927|Procedure|Unsedated colonoscopy|Patients were offered to undergo unsedated procedure. Their demographics and clinical data were recorded
16194917|NCT01434914|Drug|octenisept®|Cutaneous solution
16194918|NCT01434914|Drug|Placebo|Cutaneous use
16194919|NCT01434901|Drug|Placebo|A placebo will be taken by mouth 1 hour before ingestion of a mixed meal.
16194920|NCT01434901|Drug|Bethanechol (25 mg)|25 mg of Bethanechol will be taken by mouth 1 hour before ingestion of a mixed meal
16194921|NCT01434901|Drug|Bethanechol (50 mg)|50 mg of Bethanechol will be taken by mouth 1 hour before ingestion of a mixed meal
16194922|NCT01434901|Drug|Bethanechol (100 mg)|100 mg of Bethanechol will be taken by mouth 1 hour before ingestion of a mixed meal
16195475|NCT01430507|Drug|Revamilast|Tablet, Medium dose, Once daily for 12 weeks
16194923|NCT01434888|Drug|Preservative free tafluprost 0.0015% eye drops|Preservative free tafluprost eye drops will be administered once daily at 09:00 into both eyes for seven days. For masking purposes vehicle eye drops will be administered in the evening at 21:00.
16194924|NCT01434888|Drug|Preservative free timolol 0.5% eye drops|Preservative free timolol eye drops will be administered into both eyes twice daily at 9:00 and 21:00 for seven days
16194925|NCT01434888|Drug|Preservative free FDC of tafluprost 0.0015% and timolol 0.5% eye drops|Preservative free fixed-dose combination eye drops will be administered into both eyes once daily at 9:00 for seven days. For masking purposes vehicle eye drops will be administered in the evening at 21:00.
16194926|NCT01434862|Drug|Closed loop with pramlintide|Dose of pramlintide will be titrated based on subject's current prescribed dose. The target dose is 60 mcq three times daily.
16194927|NCT01434862|Device|Closed loop without pramlintide|This visit will assess how well the closed loop system works without the pramlintide.
16194928|NCT01434862|Drug|Open loop with pramlintide|Dose of pramlintide will be titrated based on subject's current prescribed dose. The target dose is 60 mcq three times daily.
16194929|NCT01434849|Drug|topical 0.5% Timolol maleate|topical 0.5% Timolol aqueous solution, 1-2 drops to cover the hemangioma, twice daily
16194930|NCT01434849|Drug|Control (placebo) group|Aqueous placebo, 1-2 drops to cover the hemangioma, twice daily
16194931|NCT01434836|Other|active tDCS and working memory training|This group will receive 2.0 mA anodal DC stimulation over the left DLPFC and cathodal stimulation over the right DLPFC. During the stimulation, this group will be trained on working memory processes. Sessions will be scheduled daily for two consecutive weeks.
16194932|NCT01434836|Other|sham tDCS and working memory training|This group will receive sham stimulation (e.g., identical stimulation set-up but no electric current is sent through the electrodes). Patients however receive the real working memory training, daily, for two weeks.
16194933|NCT01434823|Other|Nocturnal coverage|"The investigators will randomize, by week, nocturnal coverage. During the intervention weeks, intensivists will be in the MICU from 7pm until 7am.
~For the Intensivist Sleep and Work sub-study:
~Measurements of Daytime Intensivist work hours, sleep, and attention will be measured with actigraphy, PVT, Sleep and Work Diaries, and Surveys. Results will be compared between periods with standard staffing to periods with overnight intensivist coverage."
16194934|NCT01434810|Device|Filtered-sunlight phototherapy|Infants will receive six hours per day of filtered-sunlight phototherapy for 1 to 10 days. The filtering will be done using window tinting film. Window tinting films by Solutia, Inc., and V-KOOL, Inc.
16194935|NCT01434810|Device|Conventional phototherapy|Infants will receive six hours per day of conventional phototherapy for 1 to 10 days.
16194936|NCT01434745|Drug|Simvastatin|Simvastatin will be administered as a powder mixed with lactose at the dose of 0.5 mg/kg/day
16194937|NCT01434745|Dietary Supplement|Lactose|Lactose will be administered in a capsule formula.
16194938|NCT01434732|Procedure|Umbilical Cord Milking|UCM will be performed by the obstetric team by having the delivering obstetrician hold the infant below the mother's introitus at vaginal delivery or below the level of the incision at cesarean section and having the assistant (the second obstetrician) milk about 20 cm of umbilical cord over 2 seconds and repeating two additional times.
16194939|NCT01434732|Procedure|Immediate Cord Clamping|The umbilical cord will be clamped soon after birth without any milking of the umbilical cord.
16194940|NCT01434706|Other|Nucleic Acid Amplification Testing|The Gen-Probe Transcription-Mediated Amplification (TMA) technology exponentially amplifies captured HIV-1 and HCV RNA in blood samples. The Gen-Probe system is available in two commercially available FDA approved products; 1) the Procleix assay is a multiplex system that is used to screen the blood supply for HIV and HCV. This assay will allow the simultaneous detection of all known HIV-1 subtypes with sensitivities designed to reduce the window period of false negative results from standard HIV antibody testing (EIA), while maintaining the ability to discriminate positive from negative specimens, even at very low copy numbers (Giachetti, Linnen et al., 2002).
16194941|NCT01434693|Biological|Trichuris suis ova|single dose
16194942|NCT01434693|Other|Placebo|
16194943|NCT01434680|Biological|MenC-CRM LIQ|One dose of MenC-CRM vaccine, liquid formulation
16194944|NCT01434680|Biological|MenC-CRM ROS|One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
16194945|NCT01434680|Biological|MenC-CRM EMV|One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
16194946|NCT01434667|Behavioral|APOE genotype and Alzheimer's disease risk disclosure|Subjects with MCI will learn their own APOE genotype and a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.
16194947|NCT01434667|Behavioral|Alzheimer's disease risk disclosure|Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.
16194948|NCT01434641|Other|low-dose stress MPI SPECT|novel low-dose rest/high-dose Tc-99m sestamibi SPECT protocol with wide beam reconstruction SPECT processing
16194949|NCT01434628|Device|PrePex™ device|PrePex™ device for adult male circumcision. The PrePex™ device facilitates adult male circumcision that is bloodless with no anesthesia and no sutures
16194950|NCT01434615|Device|CRT|Patients who meet CRT device implantation guidelines (i.e., meet CRT indication and on optimal medical therapy) and receive CRT-P or CRT-D device
16194951|NCT01434615|Other|No-CRT|Patients who meet CRT device implantation guidelines (i.e., meet CRT indication and on optimal medical therapy) but who do not get a CRT-P or CRT-D device implanted
16194952|NCT01434602|Drug|everolimus|Patients will be treated with daily everolimus (days 1-28) in combination with sorafenib; There is not a defined set maximum number of cycles that a patient may have; dose escalation from 5mg to 10 mg daily
16194953|NCT01434602|Drug|sorafenib|Patients will be treated with daily everolimus (days 1-28) in combination with sorafenib; There is not a defined set maximum number of cycles that a patient may have; dose escalation from 400 mg bid, 7 days on and 7 days off to 800 mg bid
16194954|NCT01434589|Behavioral|STICA Intervention|Manualized Short-term Treatment for Internet and Computer game Addiction (STICA) based on cognitive behavior-therapy (combining individual and group therapy)
16194955|NCT01434576|Biological|HGS1025|2 mg/kg of HGS1025 administered by IV infusion on Day 0, 14, 28 and 56, and then every 28 days thereafter if patient achieves clinical response
16194956|NCT01434576|Biological|HGS1025|10 mg/kg of HGS1025 administered by IV infusion on Day 0, 14, 28 and 56, and then every 28 days thereafter if patient achieves clinical response
16194957|NCT01434576|Drug|Placebo|Placebo administered by IV infusion on Day 0, 14, 28 and 56. Subjects receiving placebo during the first 8 weeks of treatment will be given the option to receive HGS1025 10 mg/kg in the continuation phase of the study.
16194958|NCT01434550|Radiation|Stereotactic Body Radiation Therapy (SBRT)|Everyone who takes part in this study will receive SBRT. After making an individual radiation plan for each participant, they will receive 5 days of radiation to the pancreas. Participants will have follow-up visits with blood tests one month after the end of SBRT and then every 3 months for 3 years. They will also have CT scans (chest and pancreas) and FDG PET/CT (body) at 1 month and then at 3, 6, 9 and 12 months.
16194959|NCT01434550|Radiation|Tissue, Blood, Research Imaging (TBRI)|"Post-SBRT procedures (day 1, 3, 5 of SBRT, and 4 weeks after) A) Endoscopic or CT guided biopsy of treated pancreatic cancer to assess
~Necrosis/apoptosis
~Lymphocyte infiltrate and antigen presenting cells B) Imaging to evaluate cell death (day 1, 3, 5 of SBRT, and 4 weeks after)
~1. Aposense-PET imaging"
16194960|NCT01434524|Drug|LIVACT|LIVACT contains 13.0 g of free amino acids
16194961|NCT01434511|Biological|OBI-1|intravenous infusion, up to every 2-3 hours for the first 24 hours of treatment
16194962|NCT01434498|Drug|GS-5885 tablet|GS-5885 tablet, 90 mg, QD
16194963|NCT01434498|Drug|GS-9451 tablet|GS-9451 tablet, 200 mg QD
16194964|NCT01434498|Drug|tegobuvir capsule|tegobuvir capsule, 30 mg BID
16194965|NCT01434498|Drug|ribavirin tablet|ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
16194966|NCT01434498|Drug|placebo matching ribavirin tablet|placebo matching ribavirin tablet, BID
16194967|NCT01434498|Device|placebo matching tegobuvir capsule|placebo matching tegobuvir capsule, BID
16194968|NCT01434472|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic PBSCT (infusion of donor stem cells via central catheter)
16194969|NCT01434472|Drug|Cyclosporine|Given PO
16194970|NCT01434472|Drug|Fludarabine Phosphate|Given IV
16194971|NCT01434472|Radiation|Indium In-111 Ibritumomab Tiuxetan|Given IV
16194972|NCT01434472|Drug|Mycophenolate Mofetil|Given PO
16194973|NCT01434472|Other|Pharmacological Study|Correlative studies
16194974|NCT01434472|Biological|Rituximab|Given IV prior to yttrium Y 90 ibritumomab tiuxetan
16194975|NCT01434472|Radiation|Total-Body Irradiation|Undergo TBI
16194976|NCT01434472|Radiation|Yttrium Y-90 Ibritumomab Tiuxetan|Given IV
16194977|NCT01434472|Drug|Fludarabine|Given IV
16194978|NCT01434459|Drug|Gemcitabine with TheraSphere|Gemcitabine dose will be escalated and combined with therasphere.
16194979|NCT01434446|Behavioral|Sound stimulation|Listening to sound stimuli at the lowest audible level.
16194980|NCT01434420|Genetic|BRCA1 BRCA2 PTEN PALB2 mutation|detection of BRCA1 BRCA2 PTEN PALB2 mutation
16194981|NCT01434407|Other|Dietary meal intervention|Test meals with different AGE content made by different cooking methods
16194982|NCT01434394|Drug|Neo-adjuvant Erbitux-based chemotherapy|"Name/Substance: Erbitux Formulation: 2 mg/ml or 5 mg/ml Dose: 400 mg/m^2 initial, and then 250 mg/m^2 weekly Route: Intravenous infusion Frequency & treatment mode: Weekly Duration: 6 weeks
~Name/Substance: Docetaxel Formulation: Liquid (20 mg/2 ml) Dose: 75 mg/m^2 Route: Intravenous infusion Frequency & treatment mode: Day 1, every 3 weeks Duration: 2 cycles (6 weeks)
~Name/Substance: Cisplatin Formulation: Powder (30 mg) Dose: 75 mg/m^2 Route: Intravenous infusion Frequency & treatment mode: Day 1, every 3 weeks Duration: 2 cycles (6 weeks)"
16194983|NCT01434381|Biological|Pfs25-EPA/Alhydrogel|
16194984|NCT01434355|Other|Laboratory Biomarker Analysis|Correlative studies
16194985|NCT01434355|Other|Questionnaire Administration|Ancillary studies
16194986|NCT01434342|Drug|Nicotine Replacement Patch|Study participants will receive a baseline assessment after they consent to participate and before randomization. The intervention period will last 12 weeks (approximately 1 week for the in-office intervention and 12 weeks for all components of the Quitline intervention- telephone counseling and habitrol patches). Follow-up assessments will be administered at 3, 6, 12, & 24 weeks after the date of the in-person intervention (for Quitline Intervention group) or the provision of the physician letter (for the Usual Care Plus group).
16194987|NCT01434329|Genetic|DNA methylation analysis|
16194988|NCT01434329|Genetic|gene expression analysis|
16194989|NCT01434329|Genetic|microarray analysis|
16194990|NCT01434329|Other|laboratory biomarker analysis|
16194991|NCT01434329|Other|medical chart review|
16194992|NCT01434316|Drug|Dinaciclib|Given IV
16194993|NCT01434316|Drug|Veliparib|Given PO
16194994|NCT01434303|Drug|Entinostat|Given PO
16194995|NCT01434303|Other|Laboratory Biomarker Analysis|Correlative studies
16194996|NCT01434303|Drug|Lapatinib Ditosylate|Given PO
16194997|NCT01434303|Biological|Trastuzumab|Given IV
16194998|NCT01434290|Radiation|36.25 Gy IMRT|36.25 Gy in 5 fractions of 7.5 Gy twice a week over 15-17 days. A minimum of 72 hours and a maximum of 96 hours will separate each treatment. IMRT or similar techniques that use inverse treatment planning or protons are required.
16194999|NCT01434290|Radiation|51.6 Gy IMRT|51.6 Gy in 12 fractions of 4.3 Gy 5 days a week over 16-18 days. IMRT or similar techniques that use inverse treatment planning or protons are required.
16195000|NCT01434277|Other|Eye Drops with Experimental Preservative|Glycerin, Hypromellose, Polyethylene glycol 400 with experimental preservative PQ-42
16195001|NCT01434264|Procedure|Energy healing|"Healer-Ringen, a Danish national association of healers, selects healers with an educational background as required by the Registry of Alternative Practitioners (RAB) and have rooms reserved for the healing practice. The treatment takes place in the clinic of the healer and is not restricted in respect to what form of energy healing that shall be used, provided that it is based on the idea of the healer providing some kind of energy by the hands to the participant. Conversation as usual is accepted, but no other form of therapy may be provided. The intervention consists of four sessions over a period of two months, distributed as decided by each participant-healer pair."
16195002|NCT01434251|Other|Anti-hypotensive treatment|Hypotension is managed using a variety of treatment options. Options include: fluid bolus(es), dopamine, dobutamine, hydrocortisone and epinephrine.
16195003|NCT01434238|Other|Counseling and nutrition supplement|24-week intervention that includes a) a daily ration of fortified lipid-based nutrient supplement and b) nutrition counseling delivered through biweekly group and individualized sessions. Dietary supplement is a locally- produced lipid-based nutrient spread (Meds and Foods for Kid, Cap Haitian, Haiti) that in a 65g daily ration provides 345 kcal energy and single allowance of key micronutrients for the 6-12 month age group.
16195004|NCT01434225|Drug|Bumetanide|Bumetanide - Standard Phenobarbital plus either 0.05 mg/kg,0.1 mg/kg, 0.2 mg/kg, or 0.3 mg/kg of bumetanide as determined by the the dose escalation design Maximum dose allowed is 0.3mg/kg given up to 4 times at 12 hourly intervals (total of 1.2mg/kg).
16195005|NCT01434212|Drug|Interferon Alfa-2b, Ribavirin|"Interferon:dosage,5 million units/person;frequency,every other day (qod);duration,48 weeks;Subcutaneous injection.
~Ribavirin: dosage,15mg/kg/day;frequency,three times a day (t.i.d);duration,48 weeks;take orally."
16195006|NCT01434199|Procedure|UPD guidance|A real time, three-dimensional image and position of the colonoscope would be provided to the endoscopist during the procedure.
16195007|NCT01434186|Drug|Placebo matching with Saxagliptin|Tablet, Oral, 0.0 mg, Daily, Day 1 through week 52
16195008|NCT01434186|Drug|Metformin IR|Tablet, Oral, 1000 mg -2000 mg, Daily , Day 1 through week 52
16195009|NCT01434186|Drug|Metformin XR|Tablet, Oral, 1000 mg -2000 mg, Daily, Day 1 through week 52
16195010|NCT01434186|Drug|Saxagliptin|Saxagliptin Tablet, 2.5 mg, or Saxagliptin Tablet, 5 mg, (based on subject's weight)
16195011|NCT01434173|Drug|Moxifloxacin (Avelox, BAY12-8039)|Eligible patients who are new users of moxifloxacin during the study period. A new user is defined as a person who has a first recorded dispensing of moxifloxacin during the study period and who has not had a previous recorded dispensing for any of the study antimicrobials during the previous 180 days
16195012|NCT01434173|Drug|Amoxicillin, Amoxicillin plus clavulanic acid, Cefuroxime, Clarithromycin, Doxycycline, Levofloxacin, Telithromycin|Eligible patients who are new users of one of the other study antimicrobials (amoxicillin, amoxicillin plus clavulanic acid, cefuroxime, clarithromycin, doxycycline, levofloxacin, or telithromycin) during the study period. A new user is defined as a person who has a first recorded dispensing of a study a study antimicrobial during the study period and who has not had a previous recorded dispensing for any of the study antimicrobials during the previous 180 days.
16195013|NCT01434160|Drug|Skyla (Levonorgestrel, BAY86-5028)|Levonorgestrel intrauterine contraceptive system (LCS12) insertion into the uterus at insertion visit 2 with the study treatment of 12 months. An optional follow up phase up to 3 years will be offered for all subjects completing 12 month treatment time.
16195014|NCT01434147|Drug|preoperative induction chemotherapy in combination with bevacizumab followed by combined radiochemotherapy with capecitabine|Therapy start: Capecitabine 1000mg/ m² bid during 14 days(d1-14), oxaliplatin 130mg/m² and Bevacizumab 7.5mg/kg body weight d1, repetition day 22 and 43 (3 cycles) Radiotherapy: Followed by 5 x 5 days 1.8 Gy after 1 week of concluded 3rd cycle of induction chemotherapy Chemotherapy: Capecitabine 825 mg/m2 bid (on each therapy day of first 4 therapy weeks)
16195015|NCT01434134|Drug|Metoprolol|Tablet, target dose 100 mg once daily
16195016|NCT01434134|Drug|Placebo|Tablet, target dose 100 mg once daily
16195017|NCT01434134|Drug|Candesartan|Tablet, target dose 32 mg once daily
16195018|NCT01434134|Drug|Placebo|Tablet, 32 mg once daily
16195019|NCT01434121|Drug|Ascorbic Acid|The infusion of either a high dose of ascorbic acid, low dose ascorbic acid, or placebo
16195020|NCT01434121|Drug|Placebo|
16195021|NCT01434108|Drug|Ornithine-phenylacetate|"Phase A: Open-label scalating dose of OP. Treatment will be initiated at 1/3 of the final dose and will be scalated every 12 hours up to the full dose, except if there are problems of tolerance. Duration of the infusion 5 days.
~Phase B: Comparative study of experimental drug vs placebo for 5 days OP (OCR-002) at a dose of 10 g diluted in 150 ml of water for injection administered as a continuous i.v. infusion for 24 hours (8.3 ml/h)during 5 days."
16195022|NCT01434095|Procedure|half-dose photodynamic therapy|photodynamic therapy (PDT) was performed using 3 mg/m2 body surface area of verteporfin (Visudyne, Novartis AG, Bülach, Switzerland) which is one-half the conventional dose of verteporfin. The verteporfin was infused over a 10 minute period followed by the delivery of 50 J/cm2 from a 689-nm laser system (Carl Zeiss, Dublin, CA) over an 83-second exposure time.
16195023|NCT01434082|Behavioral|comparison of types of sleep disordered breathing|comparison of types of sleep disordered breathing (primary snoring, upper airway resistance syndrome, obstructive sleep apnea) in children with and without arthritis.
16195024|NCT01434069|Drug|SOM230C LAR|Participants will be given one LAR dose injected into the muscle of the buttocks by a study nurse about once every 28 days until unacceptable toxicity or progression of the disease.
16195025|NCT01434069|Drug|FOLFIRI Infusion|Standard therapy of FOLFIRI
16195026|NCT01434030|Behavioral|Focus Group|Focus group methodology was chosen to obtain qualitative and quantitative data on participants' desire to use glucose advisory systems to manage their diabetes, their concerns about and desired features and functions of these systems, and their perceived confidence with behavioral event recording. At the outset of each interview, the personalized glucose advisory system (PGASystem) was described to participants as a system composed of a continuous glucose monitor (CGM) device and insulin pump, into which they would input daily information about their insulin, food, and physical activity. The system would then use their data to create personalized algorithms and advice about various aspects of their diabetes management, such as suggestions regarding bolus and basal rate dosing. The interview consisted of open-ended, multiple choice, and dichotomous questions.
16195027|NCT01434017|Drug|Dexamethasone|Patients will receive dexamethasone 250 mcg/kg just after induction of anesthesia.
16195028|NCT01434017|Drug|Dexamethasone and droperidol|Patients will receive dexamethasone 250 mcg/kg + droperidol 10 mcg/kg just after induction of anesthesia.
16195029|NCT01434017|Drug|Dexamethasone and Ondansetron|Patients will receive dexamethasone 250 mcg/kg + ondansetron 150 mcg/kg just after induction of anesthesia.
16195030|NCT01434004|Behavioral|Lifestyle counseling|"Diet component: focus on increasing intake of whole grains, soybeans, soybean products, other beans, and vegetables.
~Physical Activity: encourage completion of morning exercise sessions. Mindfulness Stress Reduction: training in mindfulness meditation, including dealing with intensive physical symptoms and difficult emotional situations."
16195031|NCT01433991|Drug|Golvatinib|Participants will receive E7050 50 mg and/or 100 mg tablets. E7050 will be administered orally once daily, in 28-day cycles.
16195032|NCT01433991|Drug|Lenvatinib|Participants will receive lenvatinib 1 mg and/or 4 mg and/or 10 mg capsules. Lenvatinib will be administered orally once daily, in 28-day cycles.
16195033|NCT01433991|Drug|Lenvatinib|Participants will receive lenvatinib 24 mg (1*4 mg capsule + 2*10 mg capsule) capsules. Lenvatinib will be administered orally once daily, in 28-day cycles.
16195034|NCT01433978|Drug|Eltrombopag|
16195035|NCT01433978|Drug|Avatrombopag|
16195036|NCT01433978|Drug|Standard of care|"Permitted ITP concomitant background therapies are as follows:
~Corticosteroids and/or azathioprine taken at a stable dose for 4 weeks before randomization;
~Mycophenolate mofetil (MMF) or danazol taken at a stable dose for at least 12 weeks before randomization;
~Cyclosporine A (CsA) (due to the fact that it is a P-glycoprotein-mediated transport [P-gp] inhibitor) is to be avoided unless deemed medically necessary; CsA taken at a stable dose for at least 12 weeks before randomization.
~At the discretion of the investigator, participants will be allowed to use aspirin, other salicylates, or approved adenosine diphosphate (ADP) receptor antagonists, (eg, clopidogrel, prasugrel) during the study once their platelet count had risen.
~Participants treated with proton pump inhibitors (PPIs) and H2 antagonist therapy will receive a stable dose for at least 6 weeks prior to randomization. Treatment with these therapies must have been completed at least 2 weeks prior to randomization."
16195037|NCT01433965|Drug|Lenalidomide|Lenalidomide will be taken orally once a day for 21 days continuously in 28 day cycles. The dose of the lenalidomide administered to each patient will be based on the group that the patient is enrolled. The dose cycles will be 21 days of a 28 day cycle.
16195038|NCT01433952|Dietary Supplement|Thiamine|Vitamin B1
16195039|NCT01433952|Dietary Supplement|Placebo|Placebo
16195040|NCT01433913|Drug|metformin hydrochloride|Given PO
16195041|NCT01433913|Other|placebo|Given PO
16195042|NCT01433913|Other|laboratory biomarker analysis|Correlative studies
16195043|NCT01433900|Drug|Tafluprost|1 drop of tafluprost to eligible eye(s) once daily (at 9 pm)
16195044|NCT01433900|Drug|Latanoprost|1 drop of tafluprost to eligible eye(s) once daily (at 9 pm)
16195045|NCT01433887|Drug|48-weeks course|patients receive a dose of 180 µg of PEGASYS once a week for 48 weeks
16195046|NCT01433887|Drug|Ribavirin|patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks
16195047|NCT01433887|Drug|Peginterferon alfa2a|patients receive a dose of 180 µg of PEGASYS once a week for 24 weeks
16195048|NCT01433887|Drug|Ribavirin|patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 24 weeks
16195049|NCT01433874|Procedure|Pulmonary recruitment maneuver|A pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure of 60 cmH2O. The anesthesiologist held the fifth positive pressure inflation for approximately 5 seconds.
16195050|NCT01433874|Procedure|Intraperitoneal normal saline infusion|The upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500cc. We will leave the fluid in the abdominal cavity
16195051|NCT01433874|Procedure|combined group|The upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500cc. Later, a pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure oof 60 cmH2O.
16195052|NCT01433874|Procedure|Control group|Co2 was removed by passive exsufflation through the port site.
16195053|NCT01433861|Procedure|Laparoscopy-assisted gastrectomy|Laparoscopy-assisted proximal gastrectomy versus Laparoscopy-assisted total gastrectomy
16195054|NCT01433835|Drug|MBX-400|Capsule(s) for oral administration as a single dose. Planned doses include: 35, 100, 350, 700, 1000 and 1350 mg.
16195055|NCT01433835|Other|Placebo|Capsule(s) for oral administration as a single dose. Planned doses include: 35, 100, 350, 700, 1000 and 1350 mg.
16195056|NCT01433770|Drug|Amevive|Alefacept 15mg subcutaneous; once a week for 12 weeks
16195057|NCT01433757|Drug|Ampicillin|Ampicillin will be given in capsule form. Dosage will be 2 mg daily for adults and 1 mg daily for children. One capsule will be taken each day for 28 consecutive days. After the first 28 days, there will be a 7 day 'washout' period during which no capsules are taken. Following the 'washout' period, another 28-day supply of Ampicillin will be given to the patient, to be taken in the same manner as described above.
16195058|NCT01433757|Drug|Sugar pill|The sugar pill will be given in capsule form. Dosage will be 2 mg daily for adults and 1 mg daily for children. One capsule will be taken each day for 28 consecutive days. After the first 28 days, there will be a 7 day 'washout' period during which no capsules are taken. Following the 'washout' period, another 28-day supply of the sugar pill will be given to the patient, to be taken in the same manner as described above.
16195059|NCT01433744|Procedure|Non-surgical periodontal treatment|Patients included in the test group were submitted to a non-surgical periodontal treatment protocol, which consisted of oral hygiene orientation and motivation followed by mechanical plaque control involving scaling and root planning using Gracey curets (Hu-Friedy Manufacturing, Chicago, IL, USA) and ultrasonic instrumentation (Cavitron Ultrasonics, Long Island City, NY, USA), under local anesthesia (Mepivacaine 2% with epinephrine 1:100000). The treatment was performed in one or two sessions depending on the extension of the patient's periodontal condition. Patients that presented teeth unreasonable to treat due to advanced periodontitis, or any other condition were extracted under local anesthesia.
16195060|NCT01433731|Drug|placebo for SHAPE (SHP-141)|topical gelled solution
16195061|NCT01433731|Drug|SHAPE (SHP-141) 0.1% BID|topical gelled solution
16195062|NCT01433731|Drug|SHAPE (SHP-141) 0.5% BID|topical gelled solution
16195063|NCT01433731|Drug|SHAPE (SHP-141) 1.0% BID|topical gelled solution
16195064|NCT01433718|Procedure|Neuromuscular and Resistance Training|1 hour/session, 3 sessions/week, 6 weeks
16195065|NCT01433705|Other|Rb-82 Pet scans|Intravenous administration of Rb-82. Images will be taken according to standard clinical imaging protocol and reviewed. Patient will be connected to an EKG machine to monitor the heart. Blood pressure will be monitored as well. For Rb-82 images, 40 mCi (millicuries are a measurement of radioactivity) will be used. Acquisition time for both rest and stress studies should take about 30 min.
16195089|NCT01433562|Drug|DLBS1425|DLBS1425 capsule 150 mg thrice daily for 3 cycles @ 21 days. CAF (Cyclophosphamide (500 mg/m2 iv), Doxorubicin 50 mg/m2 iv, Fluorouracil 500 mg/m2 iv) or CEF (Cyclophosphamide 500 mg/m2 iv, Epirubicin 70 mg/m2 iv, Fluorouracil 500 mg/m2 iv) regimens on Day-1 of every cycle for the total of 3 cycles.
16195066|NCT01433705|Other|F-18 FDG Pet scans|"Volunteers undergoing the F-18 FDG protocols will undergo: (1) glucose loading protocol for viability protocol imaging with the hyperinsulinemic euglycemic clamp according to standard procedures in our laboratory, and (2) inflammation protocol imaging using a high fat preparatory diet and three sub-therapeutic heparin doses (10 units / kg each) according to standard laboratory procedure. When metabolically prepared with the viability protocol and the inflammation protocol (two separate days), 10 mCi (millicuries) of F-18 FDG will be administered IV per FDG protocols, via heparin lock. 40-60 minutes after FDG injections PET imaging will be performed according to standard clinical imaging protocol."
16195067|NCT01433705|Other|N-13 ammonia Pet scans|Intravenous administration of N-13. Images will be taken according to standard clinical imaging protocol and reviewed. Patient will be connected to an EKG machine to monitor the heart. Blood pressure will be monitored as well. For N-13 ammonia images, 20 mCi (millicuries) will be used. Acquisition time for both rest and stress studies should take about 30 min.
16195068|NCT01433705|Drug|Regadenoson|Regadenoson is used as a stressor; but not to study its effects.
16195069|NCT01433692|Behavioral|Brief Intervention|CANABIC is a quantitative study to validate use of BI with cannabis users: a randomized controlled trial, clustered study, comparing an intervention group (IG) and a control group (CG). The intervention is the achievement of the IB during a specific consultation. The outcome is the consumption of cannabic (Number of joints / month).
16195070|NCT01433679|Behavioral|Zamzee Intervention|The Zamzee intervention is designed to motivate middle school-aged children to increase their rates of moderate to vigorous physical activity (MVPA) by providing rewards based on amount and duration of physical activity. Rewards include gift cards to retail stores, donations to charity, small tangible goods, and customization of their cartoon-like avatars on the website.
16195071|NCT01433666|Drug|roflumilast (EU: Daxas, USA: Daliresp)|Acute intervention: 1 time each dose on different days. Capsulated
16195072|NCT01433666|Drug|Placebo|Acute intervention: single administration, capsulated form.
16195073|NCT01433666|Drug|roflumilast|Acute intervention: 1 time each dose (100ug, 300ug, 1000ug, placebo). Capsulated.
16195074|NCT01433653|Behavioral|Cognitive Behavioral Therapy for Complicated Grief|Manualized CBT with 25 sessions, once a week. Key elements are exposition and cognitive restructuring.
16195075|NCT01433627|Other|trans-radial and short-term bivalirudin|trans-radial intervention followed by Bivalirudin given immediately upon enrolment as bolus of 0.75 mg/kg followed immediately by an infusion of 1.75 mg/kg/h. This infusion should be run continuously until completion of PCI at which time the infusion should be stopped.
16195076|NCT01433627|Other|trans-radial and long-term bivalirudin infusion|"Trans-radial intervention: will be performed according to institutional guidelines and established local practice.
~Bivalirudin: given immediately upon enrolment as bolus of 0.75 mg/kg followed immediately by an infusion of 1.75 mg/kg/h. This infusion should be run continuously until completion of PCI at which time the infusion should be reduced to a dose of 0.25 mg/kg/h for at least 6 hours. An optional higher-dose infusion of 1.75 mg/kg/h is also permitted for up to 4 hours in the prolonged infusion arm but prohibited in the short bivalirudin group."
16195077|NCT01433627|Other|trans-radial and standard of care pharmacology|Unfractionated heparin (UFH) (100 IU/kg with no glycoprotein IIb/IIIa inhibitor (GPI) and 60 IU/kg with a GPI); +/- routine or bail out eptifibatide (two 180 μg /kg boluses with a 10 minute interval followed by an infusion of 2.0 μg /kg/min for 72-96 hours) or tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18 to 24 hours) or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours (maximum dose, 10 μg/min).
16195078|NCT01433627|Other|Trans-femoral and Short-term bivalirudin|"Trans-femoral intervention: will be performed according to institutional guidelines and established local practice. Access closure devices are allowed as per local practice.
~Bivalirudin will be given immediately upon enrolment as bolus of 0.75 mg/kg followed immediately by an infusion of 1.75 mg/kg/h. This infusion should be run continuously until completion of PCI."
16195079|NCT01433627|Other|trans-femoral and long-term bivalirudin infusion|"Trans-femoral intervention: will be performed according to institutional guidelines and established local practice. Access closure devices are allowed as per local practice.
~Bivalirudin will be given immediately upon enrolment as bolus of 0.75 mg/kg followed immediately by an infusion of 1.75 mg/kg/h. This infusion should be run continuously until completion of PCI at which time the infusion should be reduced to a dose of 0.25 mg/kg/h for at least 6 hours. An optional higher-dose infusion of 1.75 mg/kg/h is also permitted for up to 4 hours in the prolonged infusion arm but prohibited in the short bivalirudin group."
16195080|NCT01433627|Other|trans-femoral and standard of care pharmacology|Trans-femoral intervention: will be performed according to institutional guidelines and established local practice. Access closure devices are allowed as per local practice. Unfractionated heparin (UFH) (100 IU/kg with no glycoprotein IIb/IIIa inhibitor (GPI) and 60 IU/kg with a GPI); +/- routine or bail out eptifibatide (two 180 μg /kg boluses with a 10 minute interval followed by an infusion of 2.0 μg /kg/min for 72-96 hours) or tirofiban (25 μg/kg followed by an infusion of 0.15 μg/kg/min for 18 to 24 hours) or abciximab (bolus of 0.25 mg/kg followed by an infusion of 0.125 μg/kg/min for 12-24 hours (maximum dose, 10 μg/min).
16195081|NCT01433614|Drug|Epirubicin|75 mg/m2 i.v. every 3 weeks, both study arms
16195082|NCT01433614|Drug|Paclitaxel|175 mg/m2 i.v., every 3 weeks study arm A 155 mg/m2 i.v., every 3 weeks study arm B
16195083|NCT01433614|Drug|Capecitabine|1650 mg/m2 p.o. days 1-14 every 3 weeks study arm B
16195084|NCT01433601|Behavioral|Enhanced Treatment Support (ETS)|"An internal supporter - family member or other person trusted by the patient is trained to fill in a checklist whether the drugs has been taken and if this was observed. Anexternal supporter - a peer selected PLWHA visit the patient twice weekly the first two months. The external supporter follows a checklist and ask about general well being, psychological problems or adverse drugs reactions as well as go through the adherence since last visit, using the internal supporter checklist. If the adherence is good, the number of visits are decreased to once weekly after two months, if not, the number of visits are intensified. If there are any symptoms of opportunistic infections, immunological reconstruction syndrome or adverse drug reactions the patient are refered for medical checkup."
16195085|NCT01433588|Device|The Calmer|This platform, called the Calmer, interacts with the infant to help reduce stress to help promote better outcomes. Infants can be placed on it for care to mimic Kangaroo Care, maternal skin to skin.
16195086|NCT01433588|Other|Standard of Care|Infant would receive the standard of care for bloodwork, provided a soother and facilitated tucking.
16195090|NCT01433562|Drug|Placebo DLBS1425|Placebo DLBS1425 capsule thrice daily for 3 cycles @ 21 days. CAF (Cyclophosphamide (500 mg/m2 iv), Doxorubicin 50 mg/m2 iv, Fluorouracil 500 mg/m2 iv) or CEF (Cyclophosphamide 500 mg/m2 iv, Epirubicin 70 mg/m2 iv, Fluorouracil 500 mg/m2 iv) regimens on Day-1 of every cycle for the total of 3 cycles.
16195091|NCT01433549|Device|Lotrafilcon B|Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.
16195092|NCT01433549|Device|Senofilcon A|Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily wear and extended (overnight) wear up to 6 nights.
16195093|NCT01433523|Drug|ALK HDM AIT Placebo|Oral lyophilisate, Placebo, to be administered sublingually once daily
16195094|NCT01433523|Drug|ALK HDM AIT 6 DU|Oral lyophilisate, 6 DU, to be administered sublingually once daily for 14-18 months.
16195095|NCT01433523|Drug|ALK HDM AIT 12 DU|Oral lyophilisate, 12 DU, to be administered sublingually once daily for 14-18 months.
16195096|NCT01433510|Drug|Grazax|1 tablet/day - pre and co-seasonal
16195097|NCT01433497|Drug|Masitinib|
16195098|NCT01433497|Drug|Placebo|
16195099|NCT01433484|Behavioral|Maintenance of Weight Loss--Control|As the maintenance of weight loss randomized trial does not begin until a year after the start of this study, the intervention and control conditions are not yet specified. This will occur before randomization and this section will be updated before the first participant is randomized.
16195100|NCT01433484|Behavioral|Maintenance of Weight Loss--Experimental|
16195101|NCT01433471|Drug|Trichuris suis ova|2,500 eggs by mouth every two weeks for 12 weeks
16195102|NCT01433458|Drug|RLX030A|RLX030 is administered as a continuous 24 hour infusion
16195103|NCT01433445|Drug|panobinostat|Given 3 times a week, every other week in 28-day cycles.
16195104|NCT01433445|Drug|ruxolitinib|Given twice daily in 28-day cycles.
16195105|NCT01433432|Drug|80 mg DR-6MP|All subjects from the original study, Protocol C2/13/DR-6MP-02, whether they received test drug for 12 weeks or Purinethol for 12 weeks, will now receive an additional 12 weeks of 80 mg DR-6MP drug to be administered as 2 x 40 mg DR-6MP test tablets, once nightly, before bedtime.
16195106|NCT01433419|Drug|TAK-875|
16195107|NCT01433419|Drug|TAK-875|
16195108|NCT01433406|Drug|TAK-875|
16195109|NCT01433406|Drug|TAK-875|
16195110|NCT01433393|Drug|TAK-875|
16195111|NCT01433393|Drug|TAK-875|
16195112|NCT01433393|Drug|Placebo|
16195113|NCT01433380|Drug|PF-05175157|One single dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM.
16195114|NCT01433380|Drug|Placebo|One single dose of placebo will be administered as a powder-in-capsule in the fasting state in the AM.
16195115|NCT01433367|Device|CerPass® Total Disc Replacement|Single level cervical disc disease
16195116|NCT01433354|Drug|AFQ056|The investigational drug, AFQ056, will be provided as hard gelatin capsules. Two different oral dosage strengths,25mg and 100 mg, identical in appearance, will be used.
16195117|NCT01433328|Drug|Lidocaine|Lidocaine
16195118|NCT01433328|Drug|Placebo|Placebo
16195119|NCT01433315|Behavioral|sleep restriction|restricted sleep
16195120|NCT01433302|Procedure|Punch Biopsy|5 mm punch biopsy specimens from the affected, lymphedematous limb will be obtained just prior to lymphatico-venular bypass and six (6) months after lymphatico-venular bypass. Punch biopsies will be obtained from the radial (lateral) aspect of the upper arm approximately 10cm above the olecranon process. Biopsy specimens will be collected from the contralateral (normal) arm at the exact same location.
16195121|NCT01433289|Drug|Polyphenon E|There will be three treatment arms, each consisting of 8 participants. Two participants in each study arm will be randomized to receive placebo. Dosing will be escalated sequentially contingent on the safety profile of previous doses. Safety data from all participants receiving Polyphenon® E in the preceding arm will be evaluated and considered acceptable prior to escalation to the next higher dose. PK analyses will be also performed as each arm is completed. It is necessary to confirm EGCG pharmacokinetics in the event that the primary outcome measure of virologic response is not observed for each arm. For each PK visit on Study Days 1 and 14, a total of 10 blood samples will be obtained per subject.
16195122|NCT01433276|Drug|Hyperosmolar sodium lactate|1st loading : Upto 2 liters of Ringer's lactate, followed by Totilac which was given 5 mL/kgBW/15 minutes, followed by maintenance 2 mL/kgBW/hour for 3 hours
16195123|NCT01433276|Drug|Ringer's lactate|1st loading : Upto 2 litres of Ringer's lactate, followed by 5 mL/kgBW/15 minutes,followed by maintenance : 2 mL/kgBW/hour for 3 hours
16195124|NCT01433263|Drug|BYM338 active drug|
16195125|NCT01433263|Drug|Placebo|
16195126|NCT01433250|Drug|AIN457|(10mg/kg i.v.).
16195127|NCT01433250|Drug|AIN457|(10mg/kg i.v.).
16195128|NCT01433237|Genetic|RNA analysis|
16195129|NCT01433237|Genetic|gene expression analysis|
16195130|NCT01433237|Other|laboratory biomarker analysis|
16195131|NCT01433224|Genetic|DNA methylation analysis|
16195132|NCT01433224|Genetic|RNA analysis|
16195133|NCT01433224|Genetic|mutation analysis|
16195134|NCT01433224|Genetic|nucleic acid sequencing|
16195135|NCT01433224|Genetic|polymerase chain reaction|
16195136|NCT01433224|Genetic|polymorphism analysis|
16195137|NCT01433224|Other|laboratory biomarker analysis|
16195138|NCT01433224|Other|medical chart review|
16195139|NCT01433198|Other|Aquatic training|Aquatic training during a 6 weeks program (15 to 18 sessions of 1 hour)
16195140|NCT01433185|Other|Text message|Text messages sent to women before and after delivery
16195141|NCT01433172|Biological|Phase I - GM.CD40L.CCL21 Vaccinations|"This is a dual-agent, Phase I study with an expansion of each group at the recommended Phase II dose. Participants are entered in cohorts of 3 at the first dose level. Doses are not escalated over the course of treatment of an individual patient.
~Phase I: Participants receive the GM.CD40L.CCL21 vaccine in a standard 3+3 design."
16195196|NCT01432665|Drug|Placebo|Solid Oral Dosage. Maximum every other day (on an as needed basis)
16195197|NCT01432665|Drug|Sildenafil|Solid Oral Dosage. Maximum every other day (on an as needed basis)
16195198|NCT01432665|Drug|Testosterone|Solid Oral Dosage. Maximum every other day (on an as needed basis)
16199525|NCT01398475|Drug|LY3009104|Administered orally
16195142|NCT01433172|Biological|Phase II - GM.CD40L cells Vaccinations|Patients randomized to Arm A will receive vaccinations on 3 occasions, at 2 week intervals. 7.5 X 10^6 irradiated H1944 tumor cells, 7.5 X 10^6 irradiated H2122 cells, and containing 15 X 10^6 GM.CD40L cells (1.1 mL) will be injected intradermally into 4 separate sites (0.25 ml injected at each site), in bilateral proximal upper and lower extremities (in the regions of the axillary and inguinal nodal basins). Patients will be restaged approximately 2 weeks after vaccine 3. If patients show no sign of disease progression, patients will then be vaccinated at 4-week intervals.
16195143|NCT01433172|Biological|Phase II - GM.CD40L.CCL21 Vaccinations|"This is a dual-agent, Phase I study with an expansion of each group at the recommended Phase II dose. Participants are entered in cohorts of 3 at the first dose level. Doses are not escalated over the course of treatment of an individual patient.
~Phase II: Participants are randomized to one of the 2 arms (ratio 1:1): GM.CD40L versus GM.CD40L.CCL21. Patients in Arm B will receive vaccines at the same dose and schedule as described for patients in Arm A. In addition, their vaccine will include H1944 cells expressing CCL21. Note for patients on Arms A and B: the use of steroid medication is to be avoided for 4 weeks before to the initiation of vaccine therapy and during the vaccine treatment period."
16195144|NCT01433159|Drug|HP011-101 (Xenaderm Ointment)|The test article will be applied at approximately the thickness of a dime twice daily, or more often if removed incidental to cleansing for 14 days treatment with HP011 101.
16195145|NCT01433159|Drug|Standard Care|No restrictions are placed on the nature of this care, except that it conform to the typical practices in place during the prior 3 months and that the regimen does not include the use of a BCT ointment (ointments containing Balsam Peru, castor oil and trypsin).
16195146|NCT01433133|Biological|implantation|subcutaneous implantation of autologous dermis implant treated ex vivo with genetic vector carrying the gene for interferon alfa 2b
16195147|NCT01433120|Dietary Supplement|Lactobacillus paracasei ssp paracasei F19|10^10 CFU of Lactobacillus paracasei F19 (dissolved in a glass of water once per day)
16195148|NCT01433120|Dietary Supplement|Flax seed fibres|10 grams of flax seed fibres per day (baked into two breakfast buns)
16195149|NCT01433120|Dietary Supplement|Maltodextrin (Placebo)|Maltodextrin is dissolved in a glas of water once per day
16195150|NCT01433107|Drug|Terbinafine|1% single application
16195151|NCT01433107|Drug|Terbinafine Placebo|single application
16195152|NCT01433094|Behavioral|Falloon et al. Psychoeducation Program|The intervention aims to improve communication and problem-solving abilities in patients and their families by sessions focused on: assessment of the individual's and the family's strengths, weaknesses, and goals; education about schizophrenia and treatment; communication skills training; problem-solving training; and special problems (Falloon et al. 1985). Treatment sessions are provided on a weekly basis for months (1 hour for each session) (groups of about 8-9 persons - patients and caregivers).
16195153|NCT01433094|Behavioral|Generic Treatment|The comparator is a treatment with generic informative prospect on the disorders and with the same frequencies as the Intervention. Treatment sessions are provided on a weekly basis for 6 months (1 hour for each session) (groups of about 8-9 persons - patients and caregivers).
16195154|NCT01433081|Drug|Placebo infusion of .9 normal saline|administration of .9 normal saline
16195155|NCT01433081|Drug|administration of magnesium sulfate|administration of magnesium sulfate
16195156|NCT01433068|Device|NBTXR3|One intratumor implantation by injection
16195157|NCT01433055|Drug|Minocycline|"Minocycline Dosing:
~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day (minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
16195158|NCT01433055|Drug|Placebo|"Placebo Dosing:
~Minocycline (Dynacin® or generic) will be available in 50, 75 and 100 mg capsules. There will be matched placebo-minocycline capsules for each minocycline capsule strength. During the first week subjects will receive one 50 mg capsule twice per day(minocycline 100 mg total or matching placebo) and during weeks 2-10 subjects will receive 2- 50 mg capsules twice per day If a subject should complain of any side effect, then the blind psychiatrist will be allowed to omit the next dose of study medication and then continue the subject on the optimal treatment dose. If, despite this intervention, the subject is still unable to tolerate the 200 mg/day dose, then the dose may be lowered to 150 mg to alleviate side effects and minimize attrition."
16195159|NCT01433042|Device|capsule endoscopy|capsule endoscopy procedure
16195160|NCT01433029|Other|Surgical Video Assessments|Rate performance of the surgeon/trainee in each CAB video performance (5 recorded procedures) using two rating scales, a checklist and the Global Rating Scale. Up to 38 different recorded procedures rated while on the study, each procedure lasting about 15 minutes.
16195161|NCT01433029|Other|Video Recording of CAB|Each video begins when dissection of a coronary artery has begun and ends when all manipulation of anastomosis is complete. At least 6 separate anastomoses will be recorded, or at least 2-3 procedures. A ProXennon Surgical Headlight Camera System (a small camera that is mounted in place directly over a high-intensity light that is worn on the head) records the performance of the coronary artery bypass (CAB) procedures.
16195162|NCT01433016|Drug|13C Sodium Octanoate|13C labeled Sodium Octanoate Substrate is provided in powder form in doses of 100mg for single breath test, and is dissolved in 150cc of tap water before ingestion. Duration of the observation after the drug ingestion is one hour.
16195163|NCT01433003|Procedure|Plasma Exchange|Plasma exchange is a blood purification technique that removes plasma from the blood and replaces it with donor plasma.
16195164|NCT01432990|Device|Robot gait training|Robotic gait training for 20 minute include preparing and rest time for 10 minute plus conventional physical therapy program for 30 minute, totally 60 minute per day for 5 working day per week.
16195165|NCT01432990|Other|control|Conventional physical therapy program for 60 minute per day for 5 working day per week.
16195166|NCT01432977|Drug|paracetamol /droperidol|
16195167|NCT01432977|Drug|paracetamol / ondansetron|
16195476|NCT01430507|Drug|Revamilast|Tablet, High dose, Once daily for 12 weeks
16195168|NCT01432964|Procedure|Orbital revision surgery|Surgical revisions were performed under general anaesthesia. The orbital floor was routinely exposed via a transconjunctival incision. In patients with involvement of the medial wall, a combined transconjunctival-transcaruncular approach was used. Herniated or incarcerated tissue was then complete repositioned. Stable borders around the bony defect in the orbital floor were exposed. The aluminium template was pre-bend and controlled in situ. Type and size of mesh were chosen and adjustments performed, as needed. Following the bending of the titanium mesh according to the template, it was inserted and fixed with 1.5mm screws. Alternatively the mesh could be preformed, using a sterilized skull model to shape and contour it to a normal orbit. Finally the eye bulb mobility was controlled using fine forceps (forced duction test) and the wound closed (Vicryl 5/0 rapid; optional).
16195169|NCT01432951|Drug|Enzastaurin|Administered orally
16195170|NCT01432938|Biological|dulaglutide|Administered subcutaneously
16195171|NCT01432938|Drug|Warfarin|Administered orally
16195172|NCT01432925|Procedure|surgical intervention on Buruli ulcer|Can the need for surgical intervention be avoided by delay of the decision on surgical intervention, comparing the need on surgical intervention from time points of week 8 and week 14 (number of weeks after start of antibiotic treatment with streptomycin/rifampicin).
16195173|NCT01432912|Behavioral|Physician Educational Seminar|Participating Physicians will attend an hour long seminar on smoking cessation counselling.
16195174|NCT01432886|Drug|E7389|Eribulin mesylate (iv) will be administered on Day 1 and Day 8 of each cycle (3 weeks as 1 cycle). Trastuzumab (iv) will be administered as weekly use or tri-weekly use. Trastuzumab will be administered immediately after eribulin mesylate administration when used concomitantly.
16195175|NCT01432873|Drug|Oral selenium|Drug: selenium tablet Oral selenium 1 Tab bid from day -6/-7 until discharge
16195176|NCT01432873|Drug|Oral placebo|Drug: Placebo Oral placebo 1 Tab bid from day -6/-7 until discharge
16195177|NCT01432860|Behavioral|In-person counseling|The design is a 3 [in-person training of patients and partners (PARTNER) vs. workbook training of patients and partners (WORKBOOK) vs. an assessment only group that receives education and treatment as usual care] X 7 [baseline, 4, 8, 12, 16, 20, and 24 month follow-up] study. Standard education of melanoma patients, which are to be performed with the study partner, includes a recommendation to check moles and mark ones to remember on a body map. All participants receive the same measures and will be recruited using the same procedures, thus, yielding equivalence across conditions. Pairs will observe how to use their skin check tools and be asked to demonstrate their competence in using them.
16195178|NCT01432860|Behavioral|Workbook|Participants will read a workbook and perform skills training exercises.
16195179|NCT01432860|Behavioral|Tablet Computer-Based Education|Participants will receive their education from an interactive app designed for a tablet computer.
16195180|NCT01432834|Other|Laser in situ keratomileusis (LASIK)|"During LASIK treatments the Carriazo-Pendular microkeratome (SCHWIND eye-tech-solutions GmbH & Co.KG, Kleinostheim, Germany) with 130μm cutting head was used for the creation of the flap. The normal value of the negative pressure of the suction ring was between 600-620 mmHg and the velocity of the head movement was constant (3mm/sec). The hinge was created at the 12 o'clock position. The Allegretto Wave excimer laser (software version: 2.020 / WaveLight AG, Erlangen, Germany) was used for all ablations. Attempted ablations were modified according to the S001 Wellington nomogram for the wavefront optimised protocol."
16195181|NCT01432834|Other|Photorefractive keratectomy (PRK)|"The same surgical procedure was applied to all PG participants that included: Instillation of proparacaine hydrochloride 0.5% drops for topical anaesthesia, application of a sponge saturated with 10% alcohol to the central cornea for 20-30 seconds and subsequent de-epithelialization by means of a hockey knife.The Allegretto Wave excimer laser (software version: 2.020 / WaveLight AG, Erlangen, Germany) was used for all ablations. Attempted ablations were modified according to the S001 Wellington nomogram for the wavefront optimised protocol. A soft therapeutic lens was applied until complete re-epithelialization of the cornea was detected."
16195182|NCT01432821|Other|Apomorphine (Experimental product)|"Dosage Form: Injection Dosage: 1 or 5 mg / kg
~Route of administration: Subcutaneous
~Duration of treatment: two injections of apomorphine followed by two injections of a placebo one week after or vice versa.
~Two injections will be made by visiting during visits 2 and 3.
~The study was conducted cross-over with two visits EEG recording, the order will be randomized injections:
~Sequence A during visit 2 followed by sequence B during visit 3
~or sequence B during visit 2"
16195183|NCT01432795|Device|Gliding aids for medical compression stockings|"Each subject tests devices:
~3 gliding aids for stockings with closed tips
~3 gliding aids for stockings with open tips
~2 stocking butlers using
~3 medical compression stockings with open tip, compression class 3 (36-46mmHg)
~3 medical compression stockings w. closed tip, compression class 3 (36-46mmHg)
~2 superimposed compression stockings class 1 (18 - 21 mmHg)"
16195184|NCT01432782|Drug|Placebo|Saline 4 ml
16195185|NCT01432782|Drug|Botulinum Toxin Type A|per-endoscopic injection of 100 U of botulinum toxin dissolved in 4 ml of saline
16195186|NCT01432769|Dietary Supplement|dietary supplement high in energy and protein|"patients in the standardized diet will receive extra 500 kcal from the dietary supplement"
16195187|NCT01432756|Behavioral|Let's Talk Worksite Parenting Program|The Let's Talk Worksite Parenting Program is designed for Xhosa-speaking and Afrikaans speaking parents (separate sessions) with 11- to 15-year-old children. The 5-session program meets weekly for 2 hours. The program will include instruction on parenting skills and will cover topics relevant to promoting adolescent sexual health, such as; parental involvement; adolescent sexual behavior; HIV; violence; and alcohol/substance use. Parent participants will receive weekly exercises to help them practice their new skills at home with their child.
16195188|NCT01432743|Procedure|NavX Fusion|Using NavX Fusion to guide catheter ablation
16195189|NCT01432743|Procedure|Cartomerge|Guidance of catheter ablation using Cartomerge guidance
16195190|NCT01432730|Drug|Gefapixant|Oral tablets, BID
16195191|NCT01432730|Drug|Placebo|Oral tablets, BID
16195192|NCT01432717|Biological|ACE-536|Subjects receive a total of 2 subcutaneous doses of ACE-536 on Day 1 and Day 15.
16195193|NCT01432717|Other|Placebo|Subjects receive a total of 2 subcutaneous doses of placebo on Day 1 and Day 15.
16195194|NCT01432704|Drug|colecalciferol|Once weekly peroral colecalciferol capsules (Dekristol®, Swiss-Caps, Switzerland) that contain 20 mg of colecalciferol corresponding to 20000 IU or 0.5 mg of vitamin D3 for a duration of 12 months
16195195|NCT01432691|Procedure|Hemi (hemialloplastik)|THA vs hemi
16195199|NCT01432639|Other|Exercise-based cardiac rehabilitation program|The intervention consists of usual medical care (i.e., medicine prescription and counseling of lifestyle modifications) and an supervised outpatient aerobic exercise training, which will be performed 3 days per week for 8 weeks. Each exercise session include 10 min of warm up, 35 min of aerobic exercise (i.e., cycloergometer or treadmill) and 10 min of cool down. The exercise intensity will be calculated as 65- 75% of maximal heart rate achieved in the treadmill exercise testing. Individualized exercise prescription will be periodically adjusted. A perceived exertion scale will be used as an adjunctive intensity modulator. In addition, each patient will be encouraged to daily exercise outside the formal exercise program.
16195200|NCT01432626|Drug|I-123 radiolabeled metaiodobenzylguanidine cardiac imaging|All subjects will receive an intravenous injection of 10 mCi (370 MBq) of 123I-mIBG. A ±10% tolerance of the nominal dose will be allowed, thus yielding an acceptable dose range of 9 to 11 mCi (333 to 407 MBq). The investigational medicinal product will be administered in a volume of 5 mL (diluted using 0.9% sodium chloride as needed) and injected over 1 to 2 minutes. The patient will have planar and SPECT imaging performed after the dose is administered. This dosing and imaging procedure will be performed during the acute phase and after the patient has recovered cardiac function, approximately 6 weeks later. This means that each study subject will receive a total of 2 doses of I123-mIBG at 2 different time points.
16195201|NCT01432613|Procedure|MRI-oriented muscle biopsy|Orientation of muscle biopsy according to the MRI results
16195202|NCT01432600|Drug|Pomalidomide|Pomalidomide at 4 mg by mouth (PO) as outlined in the treatment arms.
16195203|NCT01432600|Drug|Dexamethasone|Dexamethasone at 40 mg (20 mg) PO as outlined in the treatment arms.
16195204|NCT01432600|Drug|Cyclophosphamide|"The dose escalation uses a standard 3x3 design: Ex: If none of the first 3 participants have a DLT, enter 3 participants at the next higher dose level. Once the maximum tolerated dose (MTD) of oral weekly cyclophosphamide in combination with pomalidomide and dexamethasone was determined, investigators proceeded with the second phase of the trial, a randomized phase II study comparing pomalidomide and dexamethasone with pomalidomide, dexamethasone and oral weekly cyclophosphamide delivered at the MTD determined in the phase I study."
16195205|NCT01432587|Drug|Diflunisal|Film-coated tablet, 250 mg twice daily, orally for approximately 2 years
16195206|NCT01432574|Biological|Gardasil|The First Shot: Given on the day participants joined the study (Visit 1). The Second Shot: Given about 2 months later (Visit 2). The Third Shot: Given about 6 months after the first (Visit 3).
16195207|NCT01432561|Drug|Cysteamine bitartrate|500 mg total, single dose taken orally on visits 2, 3 & 4 which must occur within a 14 day period.
16195208|NCT01432548|Procedure|ischemic preconditioning|Surgery with ischemic preconditioning in liver resection
16195209|NCT01432535|Drug|PegIFN-2b (Sylatron®)|Single 4.5 μg/kg dose
16195210|NCT01432522|Drug|Epinephrine|"Intranasal epinephrine 5 mg /spray
~Intramuscular epinephrine 0.3 mg
~Intranasal saline spray"
16195211|NCT01432509|Other|Prediabetes screening and prospective follow-up over 5 years|"The study period per patient is 5 years. The planned schedule of the study is as follows :
~Enrollment at visit V0 of subjects at high metabolic risk, based on a biological value (within the past 2 months) of moderate fasting hyperglycaemia (blood glucose ≥ 1,10 g/l and < 1,26 g/l) or fasting blood glucose ≥ 1 g/l and < 1,10 g/l with HbA1c ≥ 6,5%.
~First biological sample (B0) within 1 month following V0 (measuring fasting blood glucose + glycated hemoglobin HbA1c + lipid profile + creatinemia + liver function; and establishment of a biological sample collection to identify biomarkers).
~Annual follow-up for five years consisting in one blood sample (B1 to B5) measuring the same parameters as V0 + biological sample collection, and questionnaire on major health events or health events related to study procedures.
~End of study phone call"
16195212|NCT01432496|Drug|Ropivacaine 150 mg|Nebulization of Ropivacaine 150 mg in the peritoneal cavity
16195213|NCT01432496|Drug|saline 15 ml|Nebulization of saline 15 ml in the peritoneal cavity
16195214|NCT01432483|Drug|Denileukin diftitox (ONTAK)|Given at a dose of 9 or 18mcg/kg/day by intravenous infusion over 30 to 60 minutes for 5 consecutive days every 21 days for 8 cycles.
16195215|NCT01432470|Drug|Oxytocin|Gel for intravaginal use, 600 IU once per day for 2 weeks followed by 600 IU twice a week for ten weeks
16195216|NCT01432470|Drug|Placebo|Gel for intravaginal use of identical appearance as active substance, once per day for two weeks followed by twice a week for ten weeks
16195217|NCT01432457|Drug|desvenlafaxine succinate sustained-release 50 mg/day|50 mg tablets of DVS SR taken orally once daily for 8 weeks; 1 week of placebo taper
16195218|NCT01432457|Drug|desvenlafaxine succinate sustained-release 100 mg/day|100 mg tablets of DVS SR taken orally once daily for 8 weeks (which includes 1 week of titration at 50 mg/day); 1 week of taper at 50 mg/day
16195219|NCT01432457|Drug|placebo|50 mg and 100 mg placebo matching tablets taken orally once daily for 8 weeks; 1 week of placebo taper
16195220|NCT01432444|Drug|Aripiprazole (Abilify®) IM Depot Injection|"400 mg IM depot injection every 26-30 days. Dosage may be adjusted at the investigator's discretion to 300 mg.
~Number of injections: 6. Subjects have the option of entering the extension phase of the study and continuing with injections every 26-30 days until the drug is either commercially available, or December 2013."
16195221|NCT01432431|Procedure|spiritual therapy|Undergo palliative spiritual care
16195222|NCT01432431|Other|questionnaire administration|Ancillary studies
16195223|NCT01432431|Other|survey administration|Ancillary studies
16195224|NCT01432431|Other|counseling intervention|Undergo palliative spiritual care
16195225|NCT01432431|Other|psychosocial support for caregiver|Undergo palliative spiritual care
16195226|NCT01432431|Procedure|psychosocial assessment and care|Undergo palliative spiritual care
16195227|NCT01432418|Other|Wheelchair skills training program|A training program that uses methods based on the rehabilitation, wheelchair, and motor skills literature to teach wheelchair skills.
16195228|NCT01432405|Drug|Exenatide|Type 2 diabetic subjects will be randomized to receive exenatide 10 micrograms injected subcutaneously twice daily for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period.
16199526|NCT01398462|Drug|CWP232291|IV Infusion
16195229|NCT01432405|Drug|Pioglitazone|Type 2 diabetic subjects will be randomized to receive pioglitazone 45 mg daily orally for 12 months. Prior to randomization, all subjects will receive baseline measurements of fasting plasma glucose, plasma adipocytokines, Free Fatty Acids, insulin, plasma lipids, and HbA1c as well as measurement of liver fat content with magnetic resonance spectroscopy. All subjects will undergo repeat measurements of fasting plasma glucose, Free Fatty Acids, insulin and adipocytokines as well as hepatic fat content determination at the end of the 12 month treatment period.
16195230|NCT01432379|Biological|botulinum toxin Type A|155-195 U of botulinum toxin Type A administered intramuscularly in the face, head, and neck areas as directed by physician (approximately every 12 weeks) for 1 year.
16195231|NCT01432366|Other|SC anti-TNF|Subcutaneous (SC) anti-TNF
16195232|NCT01432353|Drug|DFRF4539A|multiple ascending doses
16195233|NCT01432340|Biological|Seasonal influenza vaccine|annual recommended Southern Hemisphere vaccine
16195234|NCT01432327|Device|SenseWear display|"Participants use the self-monitoring device (display) to aid behavior change via real-time lifestyle feedback targeting physical activity.
~The display has a versatile design that allows it to be clipped to a shirt, bag or belt loop. The Display can help participants stay in sync with their daily goals."
16195235|NCT01432327|Device|Pedometer|Participants receive a pedometer to determine their daily amount of steps. Every day they write down their amount of steps in a step diary.
16195236|NCT01432327|Device|SenseWear Armband|Participants wear the SenseWear Armband for 4 weeks
16195237|NCT01432327|Behavioral|Personal Coaching|A weekly meeting with a Personal Coach to evaluate the physical activity patterns in daily life
16195238|NCT01432314|Other|Radiation therapy|"A. Started 1 week after entry. B. Equipment: linear accelerator using 6-15 MV photons (external beam equipment). Computerized treatment planning system will be used to determine the radiation fields and 3D dose distribution.
~C. Target volume: include only the portal vein tumor thrombus and 2 cm margin into the contiguous HCC. Respiratory movement will be tracked (4D-CT).
~D. Dose:
~i) Dose for fraction: 3 Gy, at 5 fractions/week ii) Total dose: 45 Gy E. Criteria for stopping RT i) Development of grade 3 or 4 hepatotoxicity or gastrointestinal complications, as defined by CTCAE ver 4.0. Restart of RT should be within 2 weeks after stopping RT."
16195239|NCT01432314|Other|Transarterial chemoembolization|"A. Start at 2 weeks after completion of RT. B. TACE procedure: cisplatin 2 mg/kg infusion with 5-20 mL of lipiodol emulsion through the target artery of HCC. Gelfoam embolization will be used until to no tumor staining on re-angiography.
~C. At an interval of 8 weeks twice, and then every 3 months until contraindications or complete response develop."
16195240|NCT01432301|Drug|uridine triacetate|uridine triacetate granules, 10gms, q6H x 20 doses
16195241|NCT01432275|Device|ADC blood glucose meter|Subjects used the FreeStyle InsuLinx with the insulin calculator not activated. Subjects had not previously used the FreeStyle InsuLinx meter.
16195242|NCT01432275|Device|Comparator blood glucose meter|Subjects were randomly assigned one of the comparator meters. Subjects had not previously used the assigned comparator meter.
16195243|NCT01432275|Device|ADC blood glucose meter with insulin calculator active|Subjects used the FreeStyle InsuLinx with the insulin calculator activated.
16195244|NCT01432262|Biological|vaccine-13vPnC|Single dose of 0.5 ml of 13vPnC administered in deltoid muscle of arm at visit 1 (day 1)
16195245|NCT01432262|Biological|vaccine-13vPnC|Single dose of 0.5 ml of 13vPnC administered in deltoid muscle of arm at visit 1 (day 1)
16195246|NCT01432249|Drug|Enbrel group|will be decided by treating physicians
16195247|NCT01432236|Drug|Pregabalin|Pregabalin 300 or 450 mg/day dosed BID ( twice a day) for 14 weeks; 150 mg/day starting dose
16195248|NCT01432236|Drug|placebo|placebo capsules twice a day for 14 weeks
16195249|NCT01432223|Drug|Nab-paclitaxel|Nab-paclitaxel 260mg/m2 q3w
16195250|NCT01432210|Other|Post-prandial Feeding Study|
16195251|NCT01432197|Other|ADL intervention|1) ADL training, 2) home modifications, 3) delivery and supervision in adaptive equipments, and 4) instruction in self-training programs.
16195252|NCT01432184|Procedure|strategies to reverse decrease in rSO2|an alarm threshold at a value of 90% of the resting baseline cerebral saturation value (baseline - 10%) will be established. To minimize the probability of patients reaching significant decreases rSO2 values, interventions to improve cerebral oxygenation will be initiated according to the strategies described in the algorithm. The success and failure of these interventions will be noted. As in the Control group, the screen will remain blinded in the ICU and the intensivist will not see the values.
16195253|NCT01432171|Drug|Lacosamide|Given PO
16195254|NCT01432171|Other|Placebo|Given PO
16195255|NCT01432158|Biological|Prevenar 13|This vaccine will be given to healthy adults without prior pneumococcal vaccination.
16195256|NCT01432158|Biological|Pneumovax II|This vaccine will be given to healthy adults without prior pneumococcal vaccination.
16195257|NCT01432145|Drug|6-Mercaptopurine|6-Mercaptopurine (6MP) 55mg/m2 body surface area, administered orally (PO) once a day (od) in the morning 1 hour after eating, on a continuous schedule. One cycle is 28 days. Treatment is given continuously until disease progression.
16195258|NCT01432145|Drug|Methotrexate|Methotrexate (MTX) 15 mg/m2 taken orally, once a week, in the morning. One cycle is 28 days. Treatment is given continuously until disease progression.
16195259|NCT01432132|Behavioral|Interview|Face-to-face audio recorded interview. It should take about 1 hour to complete.
16195260|NCT01432132|Behavioral|Questionnaire|Questionnaire about demographic information such as age and ethnicity.
16195261|NCT01432119|Device|SIR-Spheres|100% full dose SIR-Spheres on Day 1 of Cycle 1. SIR-Spheres with yttrium-90 microspheres will be given through a catheter in a vein in the groin.
16195262|NCT01432119|Drug|Cetuximab|Starting Dose: 200 mg/m2 by vein weekly. During Cycle 1, patients will receive cetuximab during Weeks 2-4. In Cycles 2 and beyond, patients will receive cetuximab weekly.
16195263|NCT01432119|Drug|Erlotinib|Starting dose: 100 mg by mouth daily. Erlotinib will be given starting with Cycle 2 at 100 mg by mouth daily. If tolerated, the dose will be increased to 150 mg by mouth daily in Cycle 3.
16195264|NCT01432119|Procedure|Break-Through Scan|"Nuclear medicine break-through scan performed within 29 days before receiving SIR-Spheres. The results of this test will be used to determine if a full or partial dose of SIR-Spheres with yttrium-90 microspheres will be delivered."
16195345|NCT01431508|Drug|Losartan 50 mg / HCTZ 12.5 mg|Losartan 50 mg / HCTZ 12.5 mg tablet once daily for 12 weeks
16195265|NCT01432106|Drug|Aliskerin/Valsartan and Rampiril|"Patients will start on low dose Ramipril 10 mg or Valturna 150/160 at visit 2, and up-titrate to target dose of Ramipril 20 mg or Valturna 300/320 at visit 3. At visit 5, the addition of Hydrochlorothiazide (HCTZ) or amlodipine will be allowed to achieve the SBP target of < 140 mmHg. High dose will then be maintained throughout the remainder of the study. In case of symptoms of low blood pressures, the study medication may be decreased to the low dose.
~(However, all non-study medication will be manipulated, initially.)"
16195266|NCT01432093|Other|Intensive glycemic management|Intravenous insulin infusion, strict dietary intervention, carbohydrate matched subcutaneous insulin therapy. This is a multifaceted approach to achieve strict glucose goals of 90 to 120 mg/dL in the ICU and hospital wards.
16195267|NCT01432093|Other|Conventional management|Conventional treatment to control hyperglycemia with a target glucose goal of 120 to 150 mg/dL in the ICU and 140 to 180 mg/dL on the hospital floors.
16195272|NCT01432067|Other|Adapted physical activity|Physical activity advices according to a program adapted to physical status of the patient.
16195273|NCT01432067|Other|Classic physical activities|Daily physical activities based on a standard guide
16195274|NCT01432041|Behavioral|tailored health education|Health Information via a computer kiosk in the pediatric emergency department
16195275|NCT01432028|Drug|Estradiol and Progesterone|3 mg/day intranasal estradiol daily or 1,5 mg/day transdermal estradiol and 200 mg/day vaginal micronized progesterone for 14 days/month
16195276|NCT01432028|Drug|Estradiol and Drospirenone|oral estradiol 1mg and drospirenone 2 mg/day
16195277|NCT01432015|Drug|fosaprepitant|Fosaprepitant for Injection 150 mg is administered intravenously on Day 1 only as an infusion over 20-30 minutes initiated approximately 30 minutes prior to chemotherapy. Patient will receive standard pre-medications
16195278|NCT01432015|Drug|aprepitant|Aprepitant 125 mg orally 1 hour prior to chemotherapy treatment (Day 1) and 80 mg orally once daily in the morning on Days 2 and 3. patient will receive standard pre-medications
16195279|NCT01432015|Other|Oral Placebo|One pill administered on days 1-3 in conjunction with Fosaprepitant.
16195280|NCT01432015|Other|IV placebo|100 cc of IV placebo administered on day in conjunction with Aprepitant
16195281|NCT01431989|Drug|Amoxicillin powder for oral suspension (Clamoxyl®) 500mg/5mL|Test formulation
16195282|NCT01431989|Drug|Amoxil® 500mg/5mL powder for oral suspension|Reference formulation
16195283|NCT01431976|Drug|Lamictal|No comparison
16195284|NCT01431963|Drug|Lamictal|No comparison.
16195285|NCT01431950|Drug|fluticasone furoate|Inhaled corticosteroid
16195286|NCT01431950|Drug|albuterol/salbutamol|Provided as rescue relief of asthma symptoms
16195287|NCT01431937|Drug|GSK2018682|Active Drug
16195288|NCT01431937|Drug|Placebo|Placebo
16195289|NCT01431924|Drug|Higher-dose inhaled corticosteroids|fluticasone propionate 110 or 220 mcg
16195290|NCT01431924|Drug|Low-dose fixed dose fluticasone propionate/salmeterol xinafoate combination|Low dose inhaled corticosteroids/salmeterol xinafoate (100mcg/50mcg or 250 mcg/50mcg)
16195291|NCT01431911|Drug|Early maintenance treatment|Various classes of COPD maintenance treatment initiated within 30 days post index COPD exacerbation (hospitalization/ED visit)
16195292|NCT01431911|Drug|Delayed Maintenance treatment|Various classes of COPD maintenance treatment initiated after 30 days post index COPD exacerbation (hospitalization/ED visit)
16195293|NCT01431898|Drug|GS-9669 tablets|
16195294|NCT01431898|Drug|Placebo to Match GS-9669 tablet|
16195295|NCT01431885|Procedure|Diagnosis by cervical length and fibronectin|Diagnosis will be made by MOD Algorithm B
16195296|NCT01431885|Procedure|Cervical change|Diagnosis will be made by digital examination of cervical change
16195297|NCT01431859|Biological|Allergovit Birch pollen|Birch pollen specific immunotherapy. Once weekly injection for 7 weeks prior to birch pollen season for 2 consecutive seasons
16195298|NCT01431859|Other|Placebo|Placebo injection to be given subcutaneously once weekly for 7 weeks prior to birch pollen season for 2 consecutive years.
16195299|NCT01431846|Behavioral|Intervention|Informed by the interviews and best practices from the literature, pilot test the transitions of care intervention that targets patients and providers to evaluate the feasibility of the intervention to improve process of care measures, including: 1) PCP follow-up within 2-4 weeks of hospital discharge; 2) medications reconciled between pre and post-hospital discharge; 3) discharge summary available to PCP at time of visit; and 4) patient awareness of symptoms that require medical attention
16195300|NCT01431833|Drug|TR-701 FA|Oral single dose 200 mg
16195301|NCT01431820|Drug|Luliconazole Solution, 10%|Topical
16195302|NCT01431820|Drug|Vehicle Solution|Topical
16195303|NCT01431807|Drug|SYR-472|oral, for up to 52 weeks.
16195304|NCT01431794|Drug|LDE225-600mg|"Phase I: oral LDE225 (Sonidegib), 600mg daily.
~Phase II Arm A: LDE225 at the recommended phase 2 dose on Days 1, 8 and 15. Cycles repeated every 28 days."
16195305|NCT01431794|Drug|Gemcitabine|Four cycles of Gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 28 days.
16195306|NCT01431794|Drug|nab-paclitaxel|Four cycles of nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days.
16195307|NCT01431794|Drug|LDE225-400mg|Phase I: oral LDE225 (Sonidegib), 400mg daily.
16195308|NCT01431794|Drug|LDE225-800mg|Phase I: oral LDE225 (Sonidegib), 800mg daily.
16195309|NCT01431781|Drug|Stilamin+common daily treatment|"dose:250 micrograms bolus intravenous in 3 minutes when ERCP starts and continuous infusion for 11 hours after ERCP.
~Common daily treatment: fasted for 6h after ERCP, Fluid replacement, Gastric acid inhibition, Antiinflammatory."
16195310|NCT01431781|Other|Common daily practice|Fasted for 6h after ERCP, Fluid replacement, Gastric acid inhibition, Antiinflammatory
16195346|NCT01431495|Drug|Pidogrel|Pidogrel(R)75 mg/day for period ranging from 1 to 6 months.
16195347|NCT01431495|Drug|Plavix|Plavix(R) 75 mg/day for period ranging from 1 to 6 months.
16195348|NCT01431469|Dietary Supplement|Cow's milk|Powdered Whole Cow's Milk
16195311|NCT01431768|Device|Respirio Flu Test|The Respirio Flu Test (RFT) is a rapid test for identifying whether a patient is infected with the Influenza A or B virus. The test separates the Influenza virus from the patient's nose blow sample and utilizes the same underlying technology as a pregnancy test (lateral flow/immuno-chromatography) to deliver a positive or negative result in less than 10 minutes. The RFT is easy to use, designed with a 3 step process similar to that of the home pregnancy test. Results are presented to the patient as a combination of different coloured lines, depending on whether the patient has Influenza A or B.
16195312|NCT01431755|Device|Restylane SubQ|Treatment with up to 2 ml of the product
16195313|NCT01431755|Device|Restylane SubQ Lidocaine|Treatment with up to 2 ml of the product
16195314|NCT01431742|Drug|BEMA Buprenorphine|buccal soluble film; applied to the buccal mucosa twice daily
16195315|NCT01431729|Other|honey, hope,mucositis|Eligible patients were randomly allocated by a computer-generated list of random numbers to be assigned into one of three treatment groups; Group (1) received an empirical dose of 15 gm honey applied topically to the affected oral mucosa three times daily until healing or for 10 days, which ever comes first. Group (2) received an empirical dose of 5 gm of a 4:2:1 mixture of honey, olive oil-propolis extract and beeswax (HOPE) applied topically to the oral mucosa three times daily until healing or for 10 days, which ever comes first. Group (3) served as controls and received benzocaine 7.5% gel applied topically to areas of ulcers three times daily.
16195316|NCT01431716|Drug|EFI/ACT-385781A|
16195317|NCT01431690|Drug|warfarin|A single 25 mg dose of warfarin
16195318|NCT01431690|Drug|omefas|4 x 1 g capsule dose of Epanova®
16195319|NCT01431690|Drug|omega-3-acid ethyl esters|4 x 1 g capsule dose of Lovaza®
16195320|NCT01431677|Procedure|Muscle Biopsy|
16195321|NCT01431664|Drug|multikinase inhibitor AT9283|
16195322|NCT01431664|Other|laboratory biomarker analysis|
16195323|NCT01431664|Other|pharmacological study|
16195324|NCT01431651|Dietary Supplement|probiotics,digestive enzyme|patients was randomized into 3 groups: clostridium butyricum MIYAIRI group (80 mg daily) bifidobacterium Longum BB536 group (2 packs daily) biotase:4 tables per day
16195325|NCT01431638|Drug|Canakinumab 150mg in prefilled syringe|Canakinumab 150mg in prefilled syringe will be given in a single dose subcutaneously upon demand for gouty arthritis flares
16195326|NCT01431625|Other|Combined Training (endurance and strength exercises)|"All patients underwent a training program to be held for 12 weeks in sessions of 60 minutes:
~.- 20 minutes of bicycle ergometer with an initial load level of about 70% of baseline peak oxygen consumption, increasing the load every two weeks as tolerated.
~- Weightlifting in 2 sets of 6 reps of 5 simple exercises. These are held at a station multigimnastyc (CLASSIC Fitness Center, KETTLER) and are as follows: pulls Chest, Shoulder press, Butterfly, Leg extension and Leg curls. The resistance will be increased gradually from 70% of the maximum weight you can lift the patient in a single maneuver (Test 1RM). Every two weeks the maximum weight is re-evaluated to adjust the training load in each patient."
16195327|NCT01431612|Drug|Esmolol administration|50 µg/kg/min of the ß1-receptor-blocker esmolol was infused intravenous over 3 hours
16195328|NCT01431612|Drug|Phenylephrine infusion|0.01 µg/kg/min of the alpha-1-adrenergic receptor agonist phenylephrine
16195329|NCT01431612|Drug|Lactated Ringer´s solution|Intravenous Infusion of 10 ml/h lactated Ringer's solution that contained no drug
16195330|NCT01431599|Radiation|short-course radiation|33Gy/10 fractions
16195331|NCT01431586|Drug|JDtic|"The planned JDTic dose levels to be evaluated are 1 mg, 3 mg, and 10 mg; however, the actual dose levels evaluated may be different, and/or additional dose levels may be added by protocol amendment, depending on the safety and PK results of the lower doses.
~Subjects will be admitted to the clinic the day before dosing and will be confined to the clinic for 6 nights, with safety and PK evaluations and assessments lasting approximately 125 hours following administration of study drug."
16195332|NCT01431573|Behavioral|Wake Therapy|Maintaining wakefulness on alternating nights over 7 days, with continued sleep deprivation the next day.
16195333|NCT01431573|Device|light box|use of a lightbox titrated between 15-60 minutes (typically 30 minutes), timed according to chronotype score on the Morningness-Eveningness Questionnaire
16195334|NCT01431573|Drug|Lithium|For patients not already taking lithium, dose will start at 600 mg daily (all in the evening) and be adjusted in 300 mg/d increments according to weekly blood levels (i.e., lithium dose may be changed once a week if most recent blood level is too low; if too high, it will be decreased or temporarily discontinued as clinically indicated; 150 mg increments will be utilized if multiples of 300 mg result in intolerance or blood levels outside the target range (0.6 - 1.0 mEq/L)
16195335|NCT01431560|Device|fixation of the ankle fracture (Solco )|fixation with metallic implant
16195336|NCT01431560|Device|fixation of the ankle fracture (Freedom)|fixation with biodegradable implant
16195337|NCT01431547|Drug|dalotuzumab|For Part 1: dalotuzumab, intravenously (IV) over 60 minutes every three weeks, dose based on participant body surface area (BSA), starting dose of 900 mg/m^2, and escalated for successive cohorts of participants until MTD is found
16195338|NCT01431547|Drug|dalotuzumab|For Part 2: dalotuzumab IV over 60 minutes every three weeks, dose based on participant BSA, starting at the lowest tolerated dose that met PK target levels in Part 1. For Part 3: dalotuzumab IV over 60 minutes every three weeks, dose based on participant BSA, at the dose level identified for combination therapy in Part 2
16195339|NCT01431547|Drug|ridaforolimus|For Part 2: ridaforolimus 10 mg enteric coated tablets, orally, on 5 consecutive days each week, dose based on participant BSA, at 1 dose level lower than the MTD or highest dose level used in the companion study MK-8669-056. For Part 3:ridaforolimus 10 mg enteric coated tablets, orally, on 5 consecutive days each week, dose based on participant BSA, at the dose level identified for combination therapy in Part 2
16195340|NCT01431534|Drug|Ridaforolimus|Oral administration of 10 mg enteric-coated tablets at doses of 22 mg/m^2, 28 mg/m^2, or 33 mg/m^2 based on body surface area (BSA), once daily for 5 consecutive days each week in consecutive 28-day cycles.
16195341|NCT01431521|Drug|MK-4074 200 mg|2 x 100-mg capsules, orally, twice-daily (BID) for 4 weeks
16195342|NCT01431521|Drug|Placebo for MK-4074|2 x 100-mg capsules, orally, BID for 4 weeks.
16195343|NCT01431521|Drug|Pioglitazone hydrochloride 30 mg|1 x 30-mg tablet, orally, once daily for 4 weeks
16195344|NCT01431521|Drug|Placebo for pioglitazone hydrochloride|1 x 30-mg tablet, orally, once daily for 4 weeks
16195469|NCT01430533|Drug|azelaic acid pre foam formulation|
16195349|NCT01431469|Dietary Supplement|Follow-On Formula|Powdered Follow-On Formula with added long-chain Polyunsaturated fatty acid, prebiotics, and polysaccharide
16195350|NCT01431456|Drug|Dabigatran|Dabigatran
16195351|NCT01431456|Drug|Rivaroxaban|Rivaroxaban
16195352|NCT01431456|Drug|Nadroparin|Nadroparin
16195353|NCT01431443|Other|Flavanol-rich chocolate|The aim of this study is to evaluate the beneficial effect of dark chocolate consumption through the activity of flavanols on the endothelial function and blood pressure regulation, in acute (after 3 hours) and chronic effect (12 weeks), among pregnant women at high risk for preeclampsia.
16195354|NCT01431443|Other|Placebo Chocolate|Placebo intervention
16195355|NCT01431430|Drug|Cholecalciferol 100 000 UI|Cholecalciferol 100 000 UI FORTHIGHTLY for 2 months then monthly for 22 months
16195356|NCT01431430|Drug|Cholecalciferol 12 000 UI|Cholecalciferol 12 000 UI FORTHIGHTLY for 2 months then monthly for 22 months.
16195357|NCT01431404|Biological|Etanercept (Enbrel)|prefilled syringe, SC
16195358|NCT01431404|Biological|HD203|HD203, prefilled syringe, SC injection
16195359|NCT01431391|Biological|sipuleucel-T|Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
16195360|NCT01431391|Drug|leuprolide acetate|45.0 mg depot injection, 2 doses 6 months apart
16195361|NCT01431365|Behavioral|Moderate Exercise Group|Participants will be required to walk briskly (equivalent to moderate intensity) on a treadmill for 10 minutes.
16195362|NCT01431365|Behavioral|Passive Sitting Group|Participants will be required to sit passively for 10 minutes on a chair.
16195363|NCT01431352|Drug|Letrozole|2.5 mg letrozole daily from day 5 of the menses for 5 days for month 1 to 3, 5.0 mg letrozole daily from day 5 of the menses for 5 days for month 4 to 6.
16195364|NCT01431352|Drug|Chinese herbal medicine granules or Chinese herbal medicine granules placebo|twice a day for 6 month
16195365|NCT01431339|Drug|IV Dalbavancin|IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
16195366|NCT01431339|Drug|Vancomycin/Linezolid|IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg every 12 hours). Total duration of therapy is 10-14 days
16195367|NCT01431326|Drug|The POPS study is collecting PK data on children prescribed the following drugs of interest per standard of care:|
16195368|NCT01431313|Drug|Inhaled Nitrite|Each patient will receive a starting dose of 45 mg of inhaled nitrite, with one planned subsequent planned dose of 90 mg of inhaled nitrite
16195369|NCT01431300|Drug|gadofosveset|Intravenous administration of the specified dosage of gadolinium contrast agent
16195370|NCT01431287|Drug|tiotropium + olodaterol|fixed dose combination
16195371|NCT01431287|Drug|tiotropium + olodaterol|fixed dose combination
16195372|NCT01431287|Drug|tiotropium|low dose or high dose
16195373|NCT01431287|Drug|tiotropium|low dose or high dose
16195374|NCT01431287|Drug|olodaterol|one dose only
16195375|NCT01431287|Device|Respimat|Respimat inhaler
16195376|NCT01431274|Drug|tiotropium + olodaterol|fixed dose combination
16195377|NCT01431274|Drug|tiotropium|low dose
16195378|NCT01431274|Drug|olodaterol|one dose only
16195379|NCT01431274|Drug|tiotropium|high dose
16195380|NCT01431274|Drug|tiotropium + olodaterol|fixed dose combination
16195381|NCT01431274|Device|Respimat|Respimat inhaler
16195382|NCT01431261|Other|Education and training|Educational sessions in pain management 4 times and treatment sessions including instructions in training and specific exercises 8 times
16195383|NCT01431261|Behavioral|Pain management|Educational sessions in pain management 4 times
16195384|NCT01431235|Behavioral|cognitive behavioral therapy for treating ADHD symptoms|5 sessions of one hour CBT for treating ADHD symptoms by a trained health care worker
16195385|NCT01431222|Device|percutaneous treatment by implanting a Mitra Clip device|With a minimal-invasive, percutaneous catheter-based technique and trans-septal approach under transesophageal echocardiographic and fluoroscopic guidance, the MitraClip device grasps and approximates the mitral leaflets thus creating a double-orifice mitral valve with a permanent leaflet coaptation and a reduction or even abrogation of mitral regurgitation.
16195386|NCT01431209|Other|Laboratory Biomarker Analysis|Correlative studies
16195387|NCT01431209|Drug|Ruxolitinib Phosphate|Given PO
16195388|NCT01431196|Biological|Autologous dendritic cell vaccination|Autologous dendritic cell vaccination. Dendritic cells are pulsed with their own tumor antigens
16195389|NCT01431183|Behavioral|Mailed influenza vaccination reminder notice|Influenza vaccination reminder sent by postal mail
16195390|NCT01431170|Drug|Besivance Treatment Group|Subjects Receive Besivance™ ophthalmic suspension, 0.6% one drop in the study eye three times daily (TID) for 10 days.
16195391|NCT01431170|Drug|Polytrim Treatment Group|Subjects receive Polytrim ophthalmic solution one drop in the study eye three times daily (TID) for 10 days.
16195392|NCT01431157|Procedure|Nocturnal nasal oxygen|Nasal oxygen at 2 l/min will be given at night
16195393|NCT01431157|Other|No nasal oxygen|Patients will have no intervention for sleep apnea
16195394|NCT01431144|Procedure|connective tissue autograft|A connective tissue autograft is harvested from the palate and grafted at the site of implant placement on the facial surface.
16195395|NCT01431144|Procedure|connective tissue allograft|An acellular dermal matrix allograft (Alloderm, BioHorizons, Inc, Birmingham, AL, USA) is grafted at the site of implant placement on the facial surface.
16195396|NCT01431131|Procedure|Intrasocket graft|Intrasocket mineralized cancellous allograft
16195397|NCT01431131|Procedure|Intrasocket plus facial overlay graft|Intrasocket mineralized cancellous allograft plus a facial overlay graft of bovine xenograft
16195398|NCT01431118|Other|specific dragon boating training intervention|male athletes of the german national dragon boat team performing three specific training units at one day
16195399|NCT01431118|Other|specific dragon boat intervention|women athletes of the german national dragon boat team performing two specific training units and one weight lifting test at one day
16195400|NCT01431105|Drug|Atorvastatin|Atorvastatin dose titration to maximum tolerated dose (once daily for 6 weeks)
16195470|NCT01430533|Drug|Vehicle pre foam formulation|
16195471|NCT01430533|Drug|Water|
16195401|NCT01431092|Drug|Placebo|Both Circadin and placebo are encapsulated in lactose containing gelatin capsules to optimize the blinding.
16195402|NCT01431092|Drug|Melatonin|Prolonged-release melatonin (Circadin®) 2 mg, once daily, 1-2 hours before bedtime.
16195403|NCT01431079|Behavioral|HPV vaccine acceptability|One arm will receive health belief model based educational intervention and other arm will receive knowledge-based educational intervention.
16195404|NCT01431066|Device|Sham pulsed radio-frequency electromagnetic device|Disabled PRFE device
16195405|NCT01431066|Device|ActiPatch PRFE Device|Actipatch PRFE device
16195406|NCT01431053|Drug|aspirin|Aspirin 50mg po daily
16195407|NCT01431053|Drug|Exemestane|Exemestane 25mg po daily
16195408|NCT01431040|Other|No bowel prep|Participants in this group will have a regular diet and no bowel prep the day prior surgery up until midnight.
16195409|NCT01431040|Other|Clear liquid diet and 2 Fleet's enemas|Participants in this group will receive a clear liquid diet and 2 Fleets enemas in the late afternoon prior to surgery.
16195410|NCT01431014|Drug|"Dexamethasonelow-dose"|5mg
16195411|NCT01431014|Drug|"Dexamethasonehigh-dose"|15 mg
16195412|NCT01431001|Device|Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator (DSF-rTMS)|The Cervel Neurotech Deep Shaped-Field repetitive transcranial magnetic stimulator is an investigational rTMS device
16195413|NCT01430975|Drug|CardioGen-82|CardioGen-82 was not administered as part of this trial but the patients enrolled had to have received CardioGen-82 previously
16195414|NCT01430975|Drug|CardioGen-82|Patients do not received CardioGen-82 as part of this study. To be in the study they would have had to receive CardioGen-82 previously.
16195415|NCT01430949|Procedure|Catheter Ablation of Paroxysmal Atrial Fibrillation|Catheter ablation for the treatment of paroxysmal atrial fibrillation. A pulmonary vein isolation procedure will be performed using the OTW MAS and radiofrequency ablation.
16195416|NCT01430923|Drug|refrigeration free latanoprost|latanoprost Eye drops 0.005% once daily, 3 months
16195417|NCT01430923|Drug|latanoprost eye drops|latanoprost eye drops 0.005% w/v, once daily, 3 months
16195418|NCT01430910|Drug|CAZ104|IV infusion
16195419|NCT01430910|Drug|Avibactam|IV infusion
16195420|NCT01430910|Drug|Ceftazidime|IV infusion
16195421|NCT01430884|Other|Aspirated Coronary Blood|Coronary arterial blood is taken distal to the lesion before stent implantation and serve as control and coronary aspirate blood is obtained during stent implantation.
16195422|NCT01430858|Device|Strain Gauge|The study participants will each undergo sterile surgical implantation of a tibial bone strain gauge in the right leg (dominance will recorded and determined by handedness). A single stacked, 45°, rosette strain gauge (FRA-2-11 Tokyo Sokki Kenkyujo Co., Japan) will be unilaterally bonded to the medial tibial cortex and carefully aligned with the long axis of the tibia. The gauge will be attached at the mid-shaft region, to determine the transmission of the vibrations through the bone and quantification of the microstructural effect.
16195423|NCT01430858|Other|Vibration therapy|"Galileo 900 platform. Study subjects will be asked to stand on the device for a series of 36 tests, with vibrations applied at various frequencies and amplitudes. A 20-second duration of videomotion & strain gauge readings will be captured.
~Juvent 1000 platform The volunteers will stand on the platform for one minute during which a 20-second duration of videomotion & strain gauge readings will be captured.
~Power Plate Pro5 Two amplitude settings will be tested, described as low & high. The subject will stand on each platform test for up to 1 minute, during which a 20-second duration of videomotion & strain gauge readings will be captured."
16195424|NCT01430819|Biological|Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation|0.5 mL, Intramuscular
16195425|NCT01430819|Biological|Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation|0.5 mL, Intramuscular
16195426|NCT01430806|Drug|Dronedarone arm|PO Dronedarone 400 mg BID
16195427|NCT01430806|Drug|Dronedarone|Dronedarone PO 400 MG BID
16195428|NCT01430793|Drug|Vitamin D3 600,000 units IM|Vitamin D3 600,000 units will be given by Intramuscular injection and then will be repeated every 2 monthly for 2 times if vitamin D levels remain < 30 ng/ml
16195429|NCT01430793|Drug|Vitamin D3 600,000 Orally|Vitamin D3 600,000 units will be given orally and then will be repeated every 2 monthly for 2 times if vitamin D levels remain < 30 ng/ml
16195430|NCT01430793|Drug|Vitamin D3 200,000 units IM|Vitamin D3 200,000 units will be given by Intramuscular injection and then will be repeated every 2 monthly for 2 times if level of vitamin D remain < 30 ng/ml
16195431|NCT01430793|Drug|Vitamin D3 200,000 Orally|Vitamin D3 200,000 units will be given by orally and then will be repeated every 2 monthly for 2 times if level of vitamin D remain < 30 ng/ml
16195432|NCT01430780|Drug|nitrate group|Isosorbide Mononitrate orally 20mg twice per day.
16195433|NCT01430780|Drug|control group|placebo
16195434|NCT01430754|Drug|tasimelteon|20 mg tasimelteon capsules, daily
16195435|NCT01430754|Drug|Placebo|Placebo capsules, daily
16195436|NCT01430741|Behavioral|Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition)|MISSION-Vet has been developed to target mental health, substance abuse and related issues facing homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources
16195437|NCT01430741|Other|Getting To Outcomes|"GTO strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. GTO consists of a series of steps practitioners should follow in order to obtain positive results and then provides them with the guidance necessary to complete those steps with quality. According to GTO, carrying out an evidence based program includes a series of steps corresponding to three general areas: (1) planning - e.g., developing goals and performance targets, ensuring staff are trained in the evidence based program; (2) implementation - e.g., monitoring program activities, maintaining adherence to an evidence based program model, supervision; and (3) self-evaluation - e.g., tracking patient outcomes, using data to improve program operations."
16195438|NCT01430741|Behavioral|Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition)|MISSION-Vet has been developed to target mental health, substance abuse and related issues facing homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources
16195472|NCT01430520|Drug|Escitalopram|Tables with Escitalopram (10 mg), 1 tablet a day for 7 days, starting on the day of surgery
16195439|NCT01430741|Other|Getting To Outcomes|"GTO strengthens the knowledge, attitudes, and skills practitioners need to carry out evidence based programs. GTO consists of a series of steps practitioners should follow in order to obtain positive results and then provides them with the guidance necessary to complete those steps with quality. According to GTO, carrying out an evidence based program includes a series of steps corresponding to three general areas: (1) planning - e.g., developing goals and performance targets, ensuring staff are trained in the evidence based program; (2) implementation - e.g., monitoring program activities, maintaining adherence to an evidence based program model, supervision; and (3) self-evaluation - e.g., tracking patient outcomes, using data to improve program operations."
16195440|NCT01430741|Behavioral|Maintaining Independence and Sobriety Through Systems Integration, Outreach, and Networking (Veterans Edition)|MISSION-Vet has been developed to target mental health, substance abuse and related issues facing homeless Veterans through assertive outreach, psychoeducation, and linkages to community-based resources
16195441|NCT01430715|Other|Active vido games and outdoor play|Fifteen children, aged 5- to 8- years, attending a nearby preschool, with a normal body mass index (BMI)-for-age percentile between, > 5th % to < 85th %.BMI, will participate in unstructured, outdoor play and one AVGs in a randomized order. Activity type, duration and intensity will be measured via accelerometery and direct observation. The energy expenditure (EE) will be calculated from Metabolic Equivalent (MET) values and the percent of time each activity meets MVPA intensity will be calculated. A MET is the energy cost of the activity expressed as kilocalories expended per kilogram of body weight per hour of activity. If EE and intensity in AVG play is similar to EE and intensity in outdoor play, then AVG play could be a great supplement to efforts aimed at increasing PA in children.
16195442|NCT01430702|Device|Computerized medication delivery unit (Electronic Medication Management Assistant (EMMA)|The patient's prescriptions and refills are packaged in standard-sized blister cards and loaded into EMMA units. The EMMMA identifies each medication automatically - no patient input is required. When activated by the patient, the medications are selected from the blister cards and released into the delivery tray. The EMMA will remain in the patient's home for a period of 30-days immediately following hospitalization. After 30 days, the EMMA MDU will become available for the next eligible patient. This maximizes the number of patients that can benefit from the MDU, while addressing the transition period when medication-reconciliation problems are most common.
16195443|NCT01430689|Biological|Inactivated Influenza Vaccine Trivalent Types A and B|"Pregnant Woman: Randomization to receive IM injection of Vaxigrip Influenza Vaccine once
~Household and Woman/Infant surveillance
~Home visits weekly until the infant is born and reaches 6 months of age
~If the woman, her infant or other household contact has signs and symptoms consistent with Influenza Like Illness (ILI)a nasal and oropharyngeal swab will be obtained"
16195444|NCT01430689|Biological|Meningococcal Polysaccharide-Diphtheria Toxoid Conjugate Vaccine|"Pregnant Women - Randomized to receive IM injection of Menactra once
~Household and Woman/Infant surveillance
~Home visits weekly until the infant is born and reaches 6 months of age
~If the woman, her infant or other household contact has signs and symptoms consistent with Influenza Like Illness (ILI)a nasal and oropharyngeal swab will be obtained"
16195445|NCT01430676|Procedure|differences in surgical techniques|follow the risk for morbidity after incisional hernia repair
16195446|NCT01430650|Drug|Oral strogen|2 mg of estradiol every day beginning the second day of the cycle until day 7. 4 mg of estradiol every day beginning 8th day of the cycle until day 10. 6 mg of estradiol every day beginning 11th day of the cycle until day 16.
16195447|NCT01430650|Drug|Transdermal strogen|One patch of 75 mcg of estradiol hemimydrate every 48 h from 2 to day 6. Two patches of 75 mcg of estradiol hemimydrate every 48 h from 6 to day 12. Three patches of 75 mcg of estradiol hemimydrate every 48 h from 12 to day 16.
16195448|NCT01430637|Genetic|DNA analysis|
16195449|NCT01430637|Genetic|RNA analysis|
16195450|NCT01430637|Genetic|gene expression analysis|
16195451|NCT01430637|Genetic|mutation analysis|
16195452|NCT01430637|Genetic|nucleic acid sequencing|
16195453|NCT01430637|Genetic|polymerase chain reaction|
16195454|NCT01430637|Other|laboratory biomarker analysis|
16195455|NCT01430637|Other|pharmacogenomic studies|
16195456|NCT01430624|Behavioral|PPRS|Video including information psychoeducation and modeling of adaptive behavioral coping strategies for use post-assault. Shown at time of post assault medical exam.
16195457|NCT01430624|Behavioral|PIRI|Video containing pleasant imagery and relaxation instruction information. Shown at time of post assault medical exam.
16195458|NCT01430611|Biological|Meningococcal (Groups A and C) Polysaccharide Vaccine|0.5 mL, Subcutaneous
16195459|NCT01430611|Biological|Meningococcal (Groups A and C) Polysaccharide Vaccine|0.5 mL, Subcutaneous
16195460|NCT01430598|Procedure|Rotator Cuff Repair and Subacromial Decompression|Arthroscopic decompression and rotator cuff repair will be completed during the same surgical date.
16195461|NCT01430598|Other|Questionnaire|Patients will be asked to complete two separate questionnaires prior to the surgical intervention. Patients will be asked to complete the same two questionnaires at 12 weeks post surgery.
16195462|NCT01430585|Drug|PF-04691502|PF-04691502 administered as single agent for 2 weeks. After this period, patients in this arm will take PF-04691502 in combination with Letrozole until Week 6. Beyond Week 6, if considered appropriate, patients can be treated with the combination for up to 10 additional weeks until breast surgery.
16195463|NCT01430585|Drug|PF-04691502 in combination with Letrozole|PF-04691502 in combination with Letrozole will be administered for 6 weeks. Beyond Week 6, if considered appropriate, patients can be treated for up to 10 additional weeks until breast surgery.
16195464|NCT01430585|Drug|Letrozole|Letrozole will be administered for 6 weeks. Beyond Week 6, if considered appropriate, patients can be treated for up to 10 additional weeks until breast surgery.
16195465|NCT01430572|Drug|Pazopanib|Starting Dose: 200 mg by mouth on Days 1 - 5 of Cycle 1 only. On Day 6 and every cycle-day with an even number, only pazopanib administered.
16195466|NCT01430572|Drug|Everolimus|"Starting dose: 5.0 mg by mouth on Days 1 - 5 of Cycle 1. On Day 7 and every cycle-day with an odd number, only everolimus will be administered.
~Dose Expansion Phase: Maximum tolerated dose (MTD) from lead in phase."
16195467|NCT01430559|Drug|Meloxicam|7.5mg x2 once a day for 12 weeks
16195468|NCT01430559|Drug|Placebo|Study subjects will be randomized to two treatment groups: one with Meloxicam 7.5 mgx2 once a day and another one with placebo. The duration of the interventional treatment is 12 weeks.
16195477|NCT01430507|Drug|Placebo Comparator|Matching Placebo in triple dummy format, Tablet, Once daily for 12 weeks
16195478|NCT01430481|Dietary Supplement|Rosehip powder|The trial is a patient and physician blinded, 12-week, randomized controlled trial (1:1:1). Participants will be randomized into one of 3 groups: 'Standard rosehip powder' (A), 'New rosehip formulation' (B), or 'New rosehip formulation in half dose' (C). Personnel responsible for data collection will be blinded to group assignment. The patients will report on their symptoms every four weeks.
16195479|NCT01430468|Procedure|Glenoid Positioning System|Design and fabrication of patient specific instrument for placement of a guide pin to be used to aid in bone preparation for placement of a metaglene and its fixation screws or anatomic glenoid component
16195480|NCT01430455|Drug|Tranylcypromine|Tranylcypromine, between 10 mg/day and 120 mg/day throughout 16 week study
16195481|NCT01430442|Drug|Rimegepant|Rimegepant capsules
16195482|NCT01430442|Drug|Placebo|Rimegepant placebo-matching capsules
16195483|NCT01430442|Drug|Sumatriptan|Rimegepant matching sumatriptan and Rimegepant matching placebo capsules
16195484|NCT01430429|Drug|NI-0801|
16195485|NCT01430416|Drug|AEB071|
16195486|NCT01430403|Biological|Omalizumab|Participants received active omalizumab (Xolair(R)) injections and a placebo inhaler. Each participant received omalizumab (Xolair(R)) subcutaneous injections at minimum dose of 0.016 mg/kg/IgE (immunoglobulin E) [IU/mL] every 2 or 4 weeks during the 4-5 months treatment period. All participants received standardized specialist asthma care.
16195487|NCT01430403|Drug|Inhaled Corticosteroid Boost Therapy (ICS)|Self-administered fluticasone (Flovent ® Diskus®) inhalers sufficient to deliver the required 200 mcg or 500 mcg daily boost of fluticasone. All participants will receive standardized specialist asthma care.
16195488|NCT01430403|Biological|Placebo omalizumab|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 4 to 5 months. Doses (mg) and dosing frequency were determined by serum total immunoglobulin E (IgE) level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP, 2007) guidelines, under the management of an asthma specialist health care provider.
16195489|NCT01430403|Biological|Placebo fluticasone|Self-administered placebo fluticasone (placebo Flovent ® Diskus®) inhalers identical in dose and guidance as active fluticasone. All participants will receive standardized specialist asthma care.
16195490|NCT01430390|Biological|Biological/Genetically Modified T cells|Following completion of the chemotherapy, genetically modified T cells will be given intravenously at one of 3 dose levels. After the infusion patients will be monitored clinically and with serial blood and marrow evaluations to assess toxicity, therapeutic effects, and the in-vivo survival of the genetically modified T-cells. A fixed CAR EBV-CTL dose (3x106 EBV-CTLs/kg) which has been demonstrated to be the ideal manufacturing dose allowing for multiple infusions and potential for multiple patient treatments per cell line generated will be used for all patients on this trial. Cohorts will be determined separately but cohort 3 will not begin to accrue until cohort 2 has treated three (3) patients without a DLT. Each patient is eligible for up to three (3) infusions.
16195491|NCT01430390|Drug|Cyclophosphamide-based chemotherapy|Cyclophosphamide-based chemotherapy regimen will be the preferred conditioning chemotherapy prior to CAR T cell infusion for patients with CD19+ malignancy in cohort 1. Recommended chemotherapy regimen consists of single agent Cyclophosphamide at a dose of 3000 mg/m2/dose IV over 1 hour or 1500mg/m2/dose x 2 doses given daily over 1 hour given for 2 days (patients may received reduced dose of cyclophosphamide based on the clinical status of the patient at discretion of the treating physician and with written approval by the MSKCC PI of this study). Alternative cyclophosphamide or non-cyclophosphamide-based regimens based on the clinical status of the patient, disease burden, and likely-hood of response may be used at the discretion of the treating physician with written approval by MSKCC PI of the study. Conditioning chemotherapy will not be given prior to infusions # 2 and #3.
16195492|NCT01430377|Procedure|SB predilatation|Initial SB [predilatation.
16195493|NCT01430377|Procedure|No SB predilatation|Without SB predilatation
16195494|NCT01430364|Device|BIOSS LIM implantation|BIOSS LIM is a dedicated bifurcation stent system with sirolymus elution.
16195495|NCT01430364|Device|BIOSS Lim|
16195496|NCT01430364|Device|CarloS|
16195497|NCT01430351|Drug|Mefloquine|Given PO
16195498|NCT01430351|Drug|Memantine Hydrochloride|Given PO
16195499|NCT01430351|Drug|Metformin Hydrochloride|Given PO
16195500|NCT01430351|Drug|Temozolomide|Given PO
16195501|NCT01430325|Drug|Hyperbaric Oxygen (1.5 atm abs)|Hyperbaric oxygen (100% oxygen) delivered at a chamber pressure of 1.5 atm abs.
16195502|NCT01430325|Drug|Sham Chamber Session|Sham control chamber session: regular air delivered at a chamber pressure of 1.2 atm abs
16195503|NCT01430312|Drug|azelaic acid pre-foam formulation|
16195504|NCT01430312|Drug|Vehicle pre-foam formulation|
16195505|NCT01430312|Drug|Water|
16195506|NCT01430312|Drug|Sodium lauryl sulfate|
16195507|NCT01430299|Device|Demineralized Bone Matrix|Accell Evo3 in posteriolateral fusion (prospective cohort)
16195508|NCT01430299|Device|rh-BMP2|rh-BMP2 in posterolateral fusion (retrospective cohort)
16195509|NCT01430286|Behavioral|psycho-social intervention based on a web-based psycho-educational program, called Diapason.|This group will be trained for a 3 month period by a web-based psycho-educational program, Lifestyle Counseling, etc.
16195510|NCT01430286|Behavioral|Consultation in memory clinic|This group will receive treatment as usual (consultation in memory clinic every 6 months)
16195511|NCT01430260|Drug|Ciclesonide|200 ㎍ once daily
16195512|NCT01430260|Drug|Levocetirizine|5mg once daily
16195513|NCT01430260|Drug|Ciclesonide & Levocetirizine|"Omnaris (ciclesonide) 200 ㎍ once daily
~Levocetirizine 5mg once daily"
16195514|NCT01430247|Other|Amblyopia screening|Monocular vision testing at near (40cm) and distance (3m)
16195515|NCT01430234|Drug|Panzytrat 25.000 FIP-E units of Lipase|patients will experiment with Panzytrat (containing 25.000 units of lipase) to a maximum of 16 capsules a day according to general guidelines.
16195516|NCT01430221|Behavioral|Mindfulness-based Personalized Health Planning|
16195517|NCT01430221|Other|Structured & Guided Education|
16195518|NCT01430208|Procedure|resectoscopy|hysteroscopy for myomas G0 and/or polyps
16195595|NCT01429480|Procedure|Preoperative Ultrasound Guided Posterior TAP Block|
16195519|NCT01430195|Drug|Afamelanotide|NB-UVB phototherapy with or without subcutaneous, bioresorbable Afamelanotide 16 mg implants, contained in a poly(D,L-lactide-co-glycolide) implant core released over 7-10 days following implantation Other Name: CUV1647
16195520|NCT01430195|Procedure|Narrow-Band UVB Light Treatment|To be administered 3 times/week for 6 months. 72 treatments in total.
16195521|NCT01430182|Drug|Methadone|0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete.
16195522|NCT01430182|Drug|Morphine|0.2 mg*kg-1 by actual body weight, administered over 10 minutes, once induction of anesthesia and endotracheal intubation are complete.
16195523|NCT01430169|Biological|AA4500|Two injections of AA4500 0.58 mg 24 hours apart
16195524|NCT01430156|Drug|Heme arginate (Normosang)|3mg/kg as a single IV infusion prior to transplant over 30 mins and same dose repeated on day 2 post-transplantation. Each drug infusion will be followed by 100ml saline IV to flush the line.
16195525|NCT01430156|Drug|0.9% sodium chloride|Solution for infusion, this will be given prior to transplantation and again on day 2; the same as active drug.
16195526|NCT01430143|Behavioral|Exercise|Daily exercise for 12 weeks.
16195527|NCT01430130|Device|embrace device|Adhesive bandage/dressing intended to minimize scar formation.
16195528|NCT01430117|Biological|Four different concentrations of Poa pratensis allergen extract, positive control and negative control|Four concentrations of Poa pratensis allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.
16195529|NCT01430104|Drug|Teriparatide|Administered subcutaneously during the Treatment Period
16195530|NCT01430104|Drug|Aspara-CA 600 mg|Administered orally throughout the study
16195531|NCT01430104|Drug|Alfarol 1.0 µg|Administered orally throughout the study
16195532|NCT01430091|Drug|Prasugrel (clinical formulation)|Administered orally
16195533|NCT01430091|Drug|Prasugrel (Orally Disintegrating Tablet [ODT])|Administered orally
16195534|NCT01430078|Drug|ASP015K|oral tablet
16195535|NCT01430078|Drug|ASP015K|solution via oral capsule
16195536|NCT01430065|Drug|ASP015K|oral
16195537|NCT01430065|Drug|Tacrolimus|oral
16195538|NCT01430052|Drug|Drug: gemcitabine, S-1|Gemcitabine 1,000mg/㎡ is administered with 30 min intravenous infusion on day 1 and 8 every 3 weeks. S-1 60mg/㎡/day is administered orally for 2 consecutive weeks every 3 weeks.
16195539|NCT01430052|Drug|gemcitabine, S-1, radiotherapy|Gemcitabine 600mg/㎡ is administered with 30 min intravenous infusion on day 1 and 8 every 3 weeks. S-1 60mg/㎡/day is administered orally for 2 consecutive weeks every 3 weeks. Concurrent radiotherapy (a total dose of 50.4Gy) was delivered in 28 fractions.
16195540|NCT01430039|Procedure|blood sample|Blood sample from a peripheral vein, 10ml total for blood count, total serum : protein, albumin, LDH, C-reactive protein,syndecan-1
16195541|NCT01430039|Procedure|Blood sample - venous blood 10 ml.|venous blood sample from a peripheral vein, 10ml total for blood count, total serum : protein, albumin, LDH, C-reactive protein,syndecan-1
16195542|NCT01430013|Drug|Endostar and CHOPT|Endostar 7.5mg/m2, for iv for continuous 14 days cyclophosphamide, pirarubicin, vincristine, teniposide, prednisone
16195543|NCT01430000|Biological|Subcutan implantation of autologus skin graft after ex-vivo treatment|Subcutan implantation of autologus skin graft after ex-vivo treatment
16195544|NCT01429987|Drug|plecanatide|Subjects receive experimental study drug for 12 weeks.
16195545|NCT01429987|Other|Placebo|Subjects receive experimental study drug for 12 weeks.
16195546|NCT01429974|Other|amniometer model po1|"The detection of Meconium, is based on recognizing a characteristic fluoroscopic spectral pattern emitted by Meconium under light excitation at a specific wavelength.
~The diagnostic test does not require penetration into the amniotic sac and is safe, painless and simple to perform."
16195547|NCT01429961|Drug|SOX|TS-1, Oxaliplatin regimen (3week) Oxaliplatin 130 mg/m2 IV Day 1 S-1 40 mg/m2 b.i.d. Day1~14
16195548|NCT01429935|Drug|Ginger powder|capsules contain 500mg Ginger powder,every 6hours,for 5 days
16195549|NCT01429935|Drug|Ibuprofen|capsules of Ibuprofen 400 mg, every 6 hours for 5 days
16195550|NCT01429935|Other|placebo|capsules contain starch
16195551|NCT01429909|Device|MAGNETOM Avanto (MRI device)|The primary purpose is to optimize the fMRI by a quantitative measurement of the T2* in the cortex and the basal ganglia using MRI. The secondary purpose is to study the effect of age and Parkinson's disease on T2*.
16195552|NCT01429896|Other|Food challenge|Double blind placebo controlled peanut challenge. Each challenge given with or without extrinsic factors exercise or sleep restriction.
16195553|NCT01429870|Drug|Steroid active treatment|Triamcinolone in unguentum leniens 0.1%
16195554|NCT01429844|Drug|Tacrolimus|Tacrolimus therapy was started immediately after transplantation with a continuous intravenous infusion of 0.01-0.03 mg/kg/d. After extubation, the mode of delivery was switched to oral administration (b.i.d.) with doses of 0.05-0.3 mg/kg/d. Tacrolimus doses were adjusted to trough levels. Target C0 (trough) levels were 10-15 ng/ml for the first 3 months after transplantation and 8-12 ng/ml thereafter with dose adjustments according to patient outcome.
16195555|NCT01429844|Drug|Cyclosporine|Cyclosporine therapy was started immediately after transplantation with a continuous intravenous infusion of 1-3 mg/kg/d. After extubation the mode of delivery was switched to oral administration (b.i.d. or t.i.d.) with doses of 4-18 mg/kg/d. Cyclosporine doses were adjusted to C0 or C2 levels according to local practice. Target trough levels were 200 - 300 ng/ml for the first 3 months after transplantation and 150 - 200 ng/ml thereafter.
16195556|NCT01429831|Drug|Aripiprazole|starting aripiprazole dose from 2-5mg/day, dose adjustment by every week, and maximum dose can up to 15mg/day. The duration is 6 weeks.
16195557|NCT01429818|Drug|Glimepiride/metformin|4/1000 mg tablets once a day foe eight weeks
16195558|NCT01429818|Drug|Metformin|1000 mg tablets once daily for eight weeks
16195559|NCT01429805|Device|HipJack Balloon Spacer|Use of the HipJack Kit to maintain distraction of the joint during hip arthroscopy.
16195560|NCT01429792|Drug|peginterferon alfa-2a [Pegasys]|standard treatment, subcutaneously weekly
16195561|NCT01429792|Drug|ribavirin [Copegus]|standard treatment, orally daily
16195596|NCT01429480|Drug|Patient controlled analgesia|
16195896|NCT01427270|Drug|Placebo|Placebo tablets to match OXN or OXY taken orally every 12 hours
16195562|NCT01429779|Drug|Movicol|Movicol® in sachets of 13,81 gram each. One sachet consists of 13,125 gr Macrogol 3350, 178,5 mg Sodium bicarbonate, 350,7 mg Sodium chloride and 46,6 mg Potassium chloride. Administration of 1 sachet of Movicol® daily during one week preoperatively and 2 sachets of Movicol® daily postoperatively.
16195563|NCT01429766|Other|Respiratory Training|"All patients shall be sent for respiratory training to the physiotherapy department. Patients shall be counseled about respiratory training by trained staff in their own vernacular. Whenever possible, patients shall be provided one Spiroball device and taught how to use the device. In addition/alternatively patients will be taught to do pranayam(breath exercises). Patients provided with spiroball shall be instructed to use the spiroball by the prescribed technique. The following visit schedule shall be observed
~st visit Within one day of the date of simulation
~nd visit Date of Radiotherapy start Subsequently 2 visits per week during radiotherapy course shall be conducted (Tuesdays, Thursdays)"
16195564|NCT01429753|Other|Advanced Imaging Guided LV lead placement|Use of MRI to identify scar and latest activating LV segment as well as CS anatomy. This will be used to guide LV lead placement real-time.
16195565|NCT01429753|Device|Standard LV lead placement|Standard LV lead placement not guided by advanced imaging
16195566|NCT01429740|Drug|PF-05180999|Ascending single oral doses of 0.1, 0.3, 1.0, 3, 10, 30, 100, and 250 mg oral solution or capsules
16195567|NCT01429740|Drug|Placebo|Placebo oral solution or capsules
16195568|NCT01429714|Device|Individually tailored duration of elastic compression therapy|Individually tailored duration of elastic compression therapy,based on signs and symptoms according to the Villalta scale, following an initial therapeutic period of 6 months
16195569|NCT01429714|Device|Elastic compression therapy with a standard duration of 24 months|Elastic compression therapy with a standard duration of 24 months
16195570|NCT01429701|Drug|polymyxin B sulphate + prednisolone + benzocaine + clioquinol|applied 3 times / day at lesion
16195571|NCT01429701|Drug|betamethasone + gentamicin + tolnaftato + cleoquinol|applied 3 times / day at lesion
16195572|NCT01429688|Drug|Anplag|Sarpogrelate HCl 300mg once a day or 100mg three times a day for 3 days
16195573|NCT01429675|Drug|bonviva|150mg Ibandronate once a month
16195574|NCT01429662|Behavioral|Modified Relaxation (MR)|Modified Relaxation (MR) This technique intend to train participants in a group of 8-10 in only 1 session that lasts 60 minutes. After completing the training, participants will be given a hand-out on MR. They will be asked to practice MR at home once a day for 15-20 minutes during their leisure times, for at least 5 days a week during the whole 16 weeks of the study period.
16195575|NCT01429662|Behavioral|Lifestyle Education (LE)|Participants in this group will receive conventional care and lifestyle education on dietary choice and exercise.
16195576|NCT01429649|Procedure|cryotherapy or radiofrequency ablation|Cryoablation or Radiofrequency ablation is performed under CT image guidance.
16195577|NCT01429636|Behavioral|Modified Relaxation (MR)|The MR technique is modified from the AR technique that will require participants to attend only 1 session, lasting 60 minutes. After the training session, participants will be given a hand-out on MR. They will continue to practice MR at home once a day for 15-20 minutes during their leisure times, at least 5 days a week for the whole 12 weeks of the follow-up period.
16195578|NCT01429636|Behavioral|Applied Relaxation (AR)|Participants will receive 12 sessions AR training. After that they will asked to practice at home once a day for 15-20 minutes during their leisure times, at least 5 days a week for the whole 12 weeks of the follow-up period.
16195579|NCT01429623|Drug|ladostigil hemitartrate|10mg ladostigil base administered once daily as hard gelatin capsule
16195580|NCT01429623|Drug|Placebo|Placebo comparator
16195581|NCT01429610|Drug|Rituximab+mVPDL|"Induction:
~Dauno 90 mg/m2/d by civ (d1-3)
~Vinc 2 mg iv (d1, 8)
~Pred 60 mg/m2/d po (d1-14)
~for Ph(-): L-asp 4,000 units/m2/day im/sc (d17-28) for Ph(+): Imatinib 600mg/d po qd (d8-continue till the end of maintenance or just before alloHCT)
~Rituximab 375mg/m2/d (d8)
~Consolidation A (cycle1)
~D 45 mg/m2/day by continuous iv (d1, 2)
~V 2 mg iv (d1, 8)
~P 60 mg/m2/day po (d1-14)
~for Ph(-): L-asp (d1-14) for Ph(+): Imatinib
~Rituximab 375mg/m2/d (d8)
~Consolidation B (cycles2&4)
~Cyt 2,000 mg/m2/d iv over 2 hr (d1-4)
~Eto 150 mg/m2/d iv over 3 hr (d1-4)
~Rituximab 375mg/m2/d d8
~Consolidation C (cycles 3&5)
~Methotrexate 220 mg/m2 iv bolus, then 60mg/m2/h for 36 hr (d1-2, 15-16)
~Leucovorin 50 mg/m2 iv every 6hr for 3 doses,
~Rituximab 375mg/m2/d (d8&22)
~Maintenance (for 2 years)
~- for Ph(-): 6- Mercaptopurine 60 mg/m2 po qd Methotrexate 20 mg/m2 po qw for Ph(+): imatinib 600mg/d po qd
~Consider alloHCT"
16195582|NCT01429584|Drug|interscalene nerve block with 0.25% bupivacaine|interscalene nerve block performed with 20 ml of 0.25% bupivacaine
16195583|NCT01429584|Drug|interscalene block with 0.125% bupivacaine|interscalene block with 20 ml of 0.125% bupivacaine
16195584|NCT01429571|Other|No intervention|No intervention
16195585|NCT01429545|Drug|Atosiban|Atosiban was given as a bolus (6.7 mg. IV) over 1 min then an infusion of 18 mg/hr for 3 hrs followed by 6 mg/hr for 48 hrs.
16195586|NCT01429545|Drug|Atosiban and nifedipine|This group were given simultaneously as follows:Atosiban was given as a bolus (6.7 mg. IV) over 1 min then an infusion of 18 mg/hr for 3 hrs followed by 6 mg/hr for 48 hrs.Nifedipine was given in the dose of 10 mg orally every 15 min till uterine quiescence was achieved (<4 contractions/hr). Maximum dose was 40 mg in the first hour then maintenance dose of 10 mg every 4-6 h for 48 hrs was given.
16195587|NCT01429532|Procedure|phacoemulsification|Cataract surgery performed with three incision-size-dependent phacoemulsification systems (1.8, 2.2 and 3.0 mm)
16195588|NCT01429519|Drug|RPh201, botanical drug product|topical, three times per week for a period of 4 consecutive weeks, followed by a single follow up visit 3 months post end of the last treatment day
16195589|NCT01429506|Procedure|Sleeve gastrectomy|Sleeve gastrectomy
16195590|NCT01429506|Drug|Intensive medical management|Exenatide 10 mcg BD, Metformin 2-3 gm/day, 800 Kcal diet
16195591|NCT01429493|Radiation|Conventional Radiotherapy|Conventional radiotherapy will be used (8 Gy/ 1 fraction).
16195592|NCT01429493|Radiation|Biological image-guided radiotherapy with conventional dose.|Biological image-guided radiotherapy on the positron emitting tomography (PET) positive lesion with conventional dose (8Gy/ 1 fraction) will be used.
16195593|NCT01429493|Radiation|Biological image-guided SBRT with dose-escalation.|Biological image-guided stereotactic body radiotherapy (SBRT) with dose-escalation on the PET positive lesion will be used.
16195594|NCT01429480|Procedure|Preoperative Ultrasound Guided Ilioinguinal/Iliohypogastric Block|
16195597|NCT01429467|Device|Continuous Glucose Monitor (CGM) and Telemedicine (Enlite Guardian real-time system Medtronic®)|Phase 2 patients will receive 6 weeks of CGM (Enlite Guardian real-time system- Medtronic®). Optimisation of glycaemic control will be through a telemedicine system to deliver a standardised protocol to instruct changes in pump settings and insulin delivery rate. This has been devised in our department and used successfully in a clinical trial comparing MDI v. CSII in young people, sponsored by Diabetes UK. 2008-2010). Subjects will be contacted at 1, 3 and 5 weeks after starting the CGM
16195598|NCT01429454|Drug|Omega-3 Long Chain Fatty Acid|: The Omega-3FA compound will be manufactured by Ocean Nutrition Canada and contain an 2:1 proportion of EPA to DHA in which each capsule includes 370 mg EPA and 200 mg DHA as well as 2 mg/g Tocopherol. The dose will be two capsules per day for a total of 740 mg of EPA and 400 mg of DHA.
16195599|NCT01429454|Drug|Placebo|The placebo is a soybean/corn blend. Both the Omega-3FA and placebo are colored with carob (so shell is brown) and flavored with natural lemon-lime, to mask them. The dose will be 2 capsules per day.
16195600|NCT01429441|Drug|Ocriplasmin|0.125 mg single intravitreal injection
16195601|NCT01429441|Other|Sham injection|Sham injection
16195602|NCT01429428|Other|Far-IR compression stockings|The far-IR side of compression stocking will be used by subjects, during the day, for six hours a day, during 90 days.
16195603|NCT01429428|Other|No far-IR compression stockings|This side of compression stocking without far-IR radiation will be used by subjects, during the day, for six hours a day, during 90 days.
16195604|NCT01429415|Drug|Magnesium Sulfate Sandoz|Each treatment will utilize 600 mg (1.2 mL) of Magnesium Sulfate Sandoz
16195605|NCT01429415|Drug|Sodium Chloride , USP PPC|Intervention: The control group will receive Sodium Chloride , USP PPC (1.2 mL hypertonic 5.5% saline with 5 mg Salbutamol - GlaxoSmithKline/Pharmascience
16195606|NCT01429402|Drug|Botulinum Toxin Type A|1-2U/kg, at 25U/mL, into the bilateral aberrant oriented orbicularis ocuris muscle via 4 superficial injection site; only once after surgery. No additional injection is needed
16195607|NCT01429402|Drug|Botulinum Type A|b. Study group II: For revision lip surgery, immediately after revision lip surgery 3 injection of 2.5U of botulinum toxin with a distance of 0.5 cm from each injection and operative wound are injected over both sides of upper lip in a adult on the operation room just after surgery. (total dosage injected 15U)
16195608|NCT01429402|Drug|Normal Saline|Similar amount (in C.C.) of normal saline as group I will be injected after primary lip surgery at 3 months of age.
16195609|NCT01429402|Drug|Normal Saline|Similar amount (in C.C.) of normal saline as study group II will be injected after revision lip surgery (secondary cleft lip repair).
16195610|NCT01429376|Other|Pulmonary function tests|Patients underwent several pulmonary function tests (spirometry, diffusion measurement, body plethysmography) according to the study protocol 1 month after the first blood sample. COPD was diagnosed post-bronchodilation according to GOLD guidelines. Patients with newly diagnosed COPD received standard treatment for COPD. Spirometry was repeated after 3 months of standard treatment for COPD in patients with newly diagnosed COPD to confirm persistent airway obstruction (COPD) and thus exclude asthma.
16195611|NCT01429376|Other|Blood tests|"First blood sample (day 1): NT-pro-BNP, sodium, potassium, urea, creatinin, glomerular filtration rate (GFR).
~Second blood sample (after 1 month): NT-pro-BNP, sodium, potassium, urea, creatinin, GFR, haemoglobin, and arterial blood gas analysis in patients with GOLD III COPD. For systemic inflammation substudy also high sensitivity CRP, leukocytes, and platelets.
~Third blood sample (after 3 months from second blood sample): NT-pro-BNP, sodium, potassium, urea, creatinin, and GFR."
16195612|NCT01429376|Other|Questionnaires|"Minnesota Living with Heart Failure Questionnaire (MLHFQ), modified Medical Research Council (MRC) dyspnoea scale, 10-point Borg dyspnoea score.
~All questionnaires were completed on the day of initial pulmonary function tests and three months later."
16195613|NCT01429376|Other|Chest radiograph|Standard posteroanterior and lateral chest radiographs were performed and evaluated on the presence or absence of congestion and other conditions that belonged to the exclusion criteria.
16195614|NCT01429363|Procedure|Targeted disc decompression|The Targeted disc catheter is connected to Neurotherm TDD unit and heating protocol is started.In this heating protocol temperature gradually increases from 65C to 90C during a time period of 12 minutes;
16195615|NCT01429350|Drug|intravenous (IV) recombinant human tissue plasminogen activator (rtPA)|0.9mg/kg to a maximum of 90mg
16195616|NCT01429350|Device|Penumbra System|The Penumbra System is an aspiration based mechanical thrombectomy device
16195617|NCT01429337|Drug|Midostaurin|Midostaurin 25 mg soft gelatin capsules (2 capsules). The midostaurin capsules will be administered orally with 240 mL of non-carbonated water in the morning (between 8-10 AM), and in the evening (after a 12 hour break) from Day 1 to Day 6. On Day 7, midostaurin will be administered in the morning only (between 8-10 AM).
16195618|NCT01429337|Drug|Midostaurin|Midostaurin 25 mg soft gelatin capsules (2 capsules). The midostaurin capsules will be administered orally with 240 mL of non-carbonated water in the morning (between 8-10 AM) on Day 1 only.
16195619|NCT01429298|Drug|Hydromorphone|2 mg IV hydromorphone over to 2-3 minutes
16195620|NCT01429298|Drug|Usual care|Attending administers IV opioid of his choosing
16195621|NCT01429285|Drug|Hydromorphone|0.5 mg IV hydromorphone followed by an optional 0.5 mg IV dose
16195622|NCT01429285|Drug|Usual care|Attending administers any IV opioid in any dose he chooses
16195623|NCT01429272|Drug|Minocycline|100 mg po bid for 6 weeks
16195624|NCT01429272|Drug|Aspirin|81 mg po bid for 6 weeks
16195625|NCT01429272|Drug|placebo|placebo for minocycline and/or aspirin
16195626|NCT01429259|Drug|meropenem|meropenem 40mg/kg total body weight will be administered every 8 hours. Each infusion will be infused as a 3 hour infusion.
16195627|NCT01429246|Dietary Supplement|Regular Salt|Estimated Household Individual Consumption of 30 grams per day
16195628|NCT01429246|Dietary Supplement|Salt Substitute|Estimated 30 grams per day per household member
16195629|NCT01429194|Procedure|ACE Stapler|The ACE Stapler is used endoscopically, and incorporates a unique tissue capture mechanism to produce large, permanent serosa to serosa plications in a completely trans-oral approach.
16195630|NCT01429181|Drug|Non-racemic mixture of methadone HCl|Non-racemic mixture of methadone HCl capsules, 5 mg
16195631|NCT01429168|Drug|Etoricoxib|One 60-mg tablet orally daily
16195632|NCT01429168|Drug|Placebo for etoricoxib|One 60-mg tablet orally daily
16195633|NCT01429155|Genetic|Interleukin 28B genotype|Interleukin 28B genotype will be obtained from a tissue block of the liver explant (liver transplanted patients) Interleukin 28B genotype will be obtained from a blood sample drawn (liver donors)
16195634|NCT01429142|Behavioral|Treatment as usual|In this multi-center trial, the content of usual adherence care is not known prior to the study, but it is part of our data collection to examine the content and variability between clinics and professionals afterwards.
16195635|NCT01429142|Behavioral|AIMS intervention|"The AIMS-intervention is counseling intervention, using MEMS-data printed in simple plots. The following intervention steps will be followed:
~-Discussion of practical, tailored information about adherence -Identification of desired adherence level and motivations -Print of patients' MEMS-report and comparison with desired level -ID causes of non-adherence and how to deal with problems -Designing a tailored action plan. -Follow-up: evaluation of accomplishments, remaining problems and solutions, until desired level of adherence has been accomplished. -Formulation of goals for behavioral maintenance.
~Among patients starting treatment, the same elements will be delivered but MEMS-feedback can only be incorporated in the second session (after medication has been used). Moreover, a readiness element is added at treatment initiation, where patients discuss the necessity and concerns of initiating medication and are offered the possibility to practice intake for 2 weeks with placebo."
16195636|NCT01429129|Drug|Nicotine replacement therapy|Nicotine transdermal patches as per product monograph
16195637|NCT01429116|Drug|tasimelteon|20 mg tasimelteon capsules, PO daily for 24 months + 12 month optional extension
16195638|NCT01429090|Procedure|blood sampling|blood sampling before and 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 8, 10, 12, 16 hours after administration of study medication
16195639|NCT01429090|Drug|Vagantin®|administration of 2 coated tablets Vagantin® (coated tablets of 50 mg methantheline bromide)
16195640|NCT01429090|Drug|methantheline solution|administration 100 ml methantheline solution (100 mg methantheline bromide)
16195641|NCT01429090|Procedure|Measurement of salivation|"Volume of salivary gland secretion was measured by chewing a 5 x 5 cm piece of PARAFILM M® (American Can Company, UK) for 5 min. Saliva was collected in glass tubes and the amount of the stimulated saliva was measured by weighing"
16195642|NCT01429090|Procedure|Measurement of accommodation|Accommodation was measured with the optometer according to Schober (Velhagen 1972)
16195643|NCT01429090|Procedure|Pupillometry|Pupil function was assessed with the pupillograph (Compact Integrated Pupillograph, AMTech, Weinheim, Germany). The following data were obtained: pupil diameter, response to defined flash stimuli
16195644|NCT01429077|Drug|levodopa/carbidopa|The study drug (100 mg levodopa / 25 mg carbidopa), is received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks.
16195645|NCT01429077|Drug|Placebo comparator|The placebo comparator (inactive pill) is received orally 30-45 minutes before 1 hour of speech-language treatment, five days a week, for six weeks.
16195646|NCT01429064|Drug|ODM-201|ODM-201 administered orally daily
16195647|NCT01429051|Drug|Intranasal Fentanyl Spray (INFS)|Applied as 1 puff (= 1 dose) in one nostril, or applied as two puffs (= 2 doses, 1 in each nostril) with ten minutes apart.
16195648|NCT01429051|Drug|Placebo|Matching intranasal placebo spray
16195649|NCT01429038|Biological|Mesenchymal Stem Cells|Third party MSC 1,5-3,010E6/kg. No HLA matching between MSC donor and the recipient or the liver/kidney donor. One infusion at day 3+/-2.
16195650|NCT01429025|Biological|rituximab|IV
16195651|NCT01429025|Drug|bendamustine|IV
16195652|NCT01429025|Drug|lenalidomide|PO
16195653|NCT01429012|Biological|Mesenchymal Stem Cells|Mesenchymal Stem Cells. Dose= 40 X 10E6 in 2 ml. Frequency = one injection. If no evidence of a callus after 6 months a second injection can be proposed.
16195654|NCT01429012|Other|Culture medium without MSC.|2 ml of culture medium.
16195655|NCT01428999|Dietary Supplement|probiotics|probiotics 1 pack (2g) bid for three weeks
16195656|NCT01428986|Drug|Maraviroc|Maraviroc, 300mg BID for 72 weeks, except for cases with Efavirenz or Etravirine, 600mg BID for 72 weeks
16195657|NCT01428973|Drug|Mycophenolate mofetil|Tablets. For HLA-identical sibling donors:15 mg/kg t.i.d from day 0 to day 28. For alternative donor: 15 mg/kg, from day 0 to day 42.
16195658|NCT01428973|Drug|Sirolimus|Tablets. 6 mg loading dose on day -3, followed by (1)-2 mg daily to a target trough level of 5 to 10 ng/mL. Full doses will be given until day 100 (sibling recipients) or 180 (alternative donor recipients). Doses will then be progressively tapered to be definitely discontinued by day 180 (sibling donors) or 365 (alternative donor recipients) in the absence of GVHD.
16195659|NCT01428960|Dietary Supplement|Palm Mid Fraction, Shea Butter, High Oleic Sunflower Oil|Acute effect of sn-1 and sn-3 palmitic acid-rich or stearic acid-rich fats on postprandial lipemia, haemostatic and inflammatory markers, gut hormone concentrations, satiety, and insulinemic response in human volunteers ; 6 wk each with 2 week wash out in between
16195660|NCT01428947|Procedure|Arterial approach|Randomization to right radial or femoral approach
16195661|NCT01428921|Behavioral|Theory based education and brief motivation interview|"Standard education programme as described above,
~Plus
~Face-to-face session (Part 1: Knowledge Enhancement Session, Part 2: Brief Motivation Interview Session) after the morning of CPAP titration
~Follow-up phone call would be arranged within 1 week after using CPAP.
~Video, slides and booklets would be used as education media."
16195662|NCT01428908|Biological|A+C+hib Conjugate Vaccine|The group A, C polysaccharide meningococcal and type b haemophilus influenzal conjugate vaccine (Wuxi Royal Biological Co., LTD, 20110101) will be administered intramuscularly on one arm, per 0.5ml dose
16195663|NCT01428908|Biological|Placebo|Placebo will be administered intramuscularly on the other arm, per 0.5ml dose
16195664|NCT01428908|Biological|A+C Vaccine|The group A, C polysaccharide meningococcal vaccine (Wuxi Royal Biological Co., LTD, 20101202) will be administered intramuscularly on one arm, per 0.5ml dose
16195665|NCT01428908|Biological|Hib vaccine|The type b haemophilus influenzal vaccine (Sanofi Pasteur Limited) will be administered intramuscularly on the other arm, per 0.5ml dose
16195666|NCT01428895|Procedure|Surgery Alone|Although we are looking at two groups, this intervention is not protocol specific but is part of the patient's standard management plan. The protocol specific part of the study is completely observational. This involves data being recorded by the attending physician during assessment and patient accounts recorded in the form of questionnaires.
16195715|NCT01428622|Drug|BI54903|ethanolic solution
16195667|NCT01428895|Other|Combined Surgery and Radiation therapy|Although we are looking at two groups, this intervention is not protocol specific but is part of the patient's standard management plan. The protocol specific part of the study is completely observational. This involves data being recorded by the attending physician during assessment and patient accounts recorded in the form of questionnaires.
16195668|NCT01428882|Drug|Midazolam|Midazolam (5 mg/5 mL) 2 mg before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level
16195669|NCT01428882|Drug|Propofol|Placebo (normal saline 2 ml) before standard propofol induction (0.5-1.5 mg/Kg) and boluses-based sedation during colonoscopy, targeted to a moderate sedation level
16195670|NCT01428843|Drug|FERRISAT|A single infusion of 50 mg/ml of Ferrisat during inclusion visit.
16195671|NCT01428843|Drug|PLACEBO|A single infusion of Glucose 5% solution during inclusion visit
16195672|NCT01428830|Procedure|7-day catheterization following fistula repair surgery|This group will have an indwelling urethral catheter for 7 days following fistula repair surgery.
16195673|NCT01428830|Procedure|14 day catheterization|This group will have an indwelling urethral catheter for 14 days following fistula repair surgery.
16195674|NCT01428817|Drug|Carbetocin|20mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
16195675|NCT01428817|Drug|Carbetocin|40mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
16195676|NCT01428817|Drug|Carbetocin|60mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
16195677|NCT01428817|Drug|Carbetocin|80mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
16195678|NCT01428817|Drug|Carbetocin|100mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
16195679|NCT01428804|Device|transcranial Direct Current Stimulation (tDCS)|Device: Eldith DC-Stimulator real or sham tDCS for 20 minutes at 2mA intensity over the left DLPFC (F3 according to the 10-20 system) Other Name: Eldith DC - Stimulator (neuroConn GmbH, Ilmenau, Germany)
16195680|NCT01428791|Behavioral|Generations older adult membership program|"Rush Generations is a membership program for older adults emphasizing chronic disease prevention and management through a wide range of health and aging-related programs. Participants assigned to the Generations intervention are actively encouraged to participate in activities, including:
~• RUSH-based lectures by experts in the fields of health and aging providing practical information and resources on physical and mental health, functional status, and social support. • Individual and family consultations with social work staff. • Health fairs with a variety of assessment services and information about community-based social service and health agencies. • Assistance with referral to community programs such as physical activity, driver safety events, and mind-body connection workshops."
16195681|NCT01428791|Behavioral|BRIGHTEN Heart Virtual Team intervention|"BRIGHTEN Heart provides an interdisciplinary team evaluation of physical and mental health and on-going support for mental health & health behavior change for 6 - 12 months, including:
~• Comprehensive health risk assessment by a licensed social worker, including physical, mental, and functional status. • Virtual team case review and recommendations by interdisciplinary team including psychologist, social worker, occupational therapist, pharmacist, chaplain, dietitian, geriatric psychiatrist, and patient's primary care physician. • Development of Patient Centered Action Plan, in which the social worker assists the patient in prioritizing recommendations. • Monthly telephone calls by the social worker to support implementation of Action Plan and Case Management. • Evidence Based Psychotherapy, as needed, delivered by supervised geriatric psychology and social work fellows."
16195682|NCT01428739|Device|MRS|Procedure
16195683|NCT01428726|Drug|NT-KO-003|NT-KO-003 is a coated tablet, administered once a day
16195684|NCT01428713|Drug|Oral tranexamic acid|Group A received oral tranexamic acid at 1300 mg (two 650mg tablets), three times each day on days 1 to 5 of menstrual cycle for 3 cycles.
16195685|NCT01428713|Drug|Oral Contraceptive Pills|Group B received combined oral contraceptive pills with 3 weeks of hormonal pills and 1 week of placebo for 3 cycles.
16195686|NCT01428687|Behavioral|Sleep Duration|Subjects are taught sleep hygiene strategies to increase their sleep; they record their sleep in a diary and wear an actigraph and call in their sleep to the office each day.
16195687|NCT01428687|Behavioral|No change in sleep|This group is taught to maintain their current sleep habits.
16195688|NCT01428674|Other|Interpersonal Mindful Compassion with Touch|A practitioner lightly touches the participant on the hands, arms, shoulders, lower legs and feet while extending loving kindness to the participant.
16195689|NCT01428674|Other|Reading while extending loving kindness|The practitioner sits in a room with the participant, pretending to read, while extending loving kindness to the participant.
16195690|NCT01428661|Drug|tasimelteon|20 mg once daily
16195691|NCT01428661|Drug|placebo|once daily
16195692|NCT01428648|Behavioral|Ballroom Dancing Classes|bi-weekly, 12-Week ballroom dance classes
16195693|NCT01428635|Drug|Eltrombopag Olamine|Given PO
16195694|NCT01428622|Device|Respimat|aqueous and ethanolic solution
16195695|NCT01428622|Device|Respimat|aqueous and ethanolic solution
16195696|NCT01428622|Device|Respimat|aqueous and ethanolic solution
16195697|NCT01428622|Device|Respimat|aqueous and ethanolic solution
16195698|NCT01428622|Device|Respimat|aqueous and ethanolic solution
16195699|NCT01428622|Device|Respimat|aqueous and ethanolic solution
16195700|NCT01428622|Device|Respimat|aqueous and ethanolic solution
16195701|NCT01428622|Drug|Olodaterol|aqueous solution
16195702|NCT01428622|Drug|Olodaterol|aqueous solution
16195703|NCT01428622|Drug|Olodaterol|aqueous solution
16195704|NCT01428622|Drug|Olodaterol|aqueous solution
16195705|NCT01428622|Drug|Olodaterol|aqueous solution
16195706|NCT01428622|Drug|Olodaterol|aqueous solution
16195707|NCT01428622|Drug|Olodaterol|aqueous solution
16195708|NCT01428622|Drug|Olodaterol & BI54903|ethanolic solution
16195709|NCT01428622|Drug|Olodaterol & BI54903|ethanolic solution
16195710|NCT01428622|Drug|Olodaterol & BI54903|ethanolic solution
16195711|NCT01428622|Drug|Olodaterol & BI54903|ethanolic solution
16195712|NCT01428622|Drug|Olodaterol & BI54903|ethanolic solution
16195713|NCT01428622|Drug|Olodaterol & BI54903|ethanolic solution
16195714|NCT01428622|Drug|Olodaterol & BI54903|ethanolic solution
16195722|NCT01428609|Procedure|Amalgam|In all surgical intervention a zinc free amalgam (Tytin. Kerr Sybron Crop., Romulus, MI) was used in the root end prepared spaces as root end filling material. Blood samples were collected in three period of time immediately before and immediately after each surgery and also one week later.
16195723|NCT01428596|Biological|HIVAX|Vaccine 1.0 ml SQ lower dose (10^8 TU) at weeks 0, 8 and 16.
16195724|NCT01428596|Biological|saline solution|Saline solution 1.0 ml SQ at weeks 0, 8 and 16.
16195725|NCT01428596|Biological|HIVAX|Vaccine 1.0 ml SQ higher dose (10^9 TU) at weeks 0, 8 and 16.
16195726|NCT01428583|Drug|oxycodone HCl and naltrexone HCl extended-release capsules|Daily dose range of 20 mg to 160 mg of the oxycodone component in a 24 hour time interval, administered twice daily approximately 12 hours apart (At the discretion of the Investigator, oxycodone HCl and naltrexone HCl extended-release capsules may be administered once daily, at 24 hour intervals.)
16195727|NCT01428570|Device|Pentax-AWS (AWS; Pentax Corporation, Tokyo, Japan)|Each group of patients will be intubated using the Macintosh laryngoscope or Pentax-AWS.
16195728|NCT01428544|Drug|Fondaparinux sodium|For patients whose body weight is 100 kg or more, fondaparinux is injected 10 mg subcutaneously once daily for treatment of acute pulmonary thromboembolism or acute deep venous thrombosis.
16195729|NCT01428531|Drug|Fondaparinux Sodium|
16195730|NCT01428518|Drug|Lamotrigine tablets|Administered according to the prescribing information in the locally approved label by the authorities.
16195731|NCT01428505|Radiation|[18F]PBR111|radioligand to assess binding to TSPO
16195732|NCT01428492|Drug|GSK2110183|The oral, once daily dose of GSK2110183 will be dependent on the cohort to which a subject is assigned. Subjects enrolled in Cohort 1 will receive 75 mg GSK2110183 once daily. Dose escalation in Schedule A and Schedule B will follow 25 mg increments in a 3+3 dose escalation procedure up to a maximum of 150mg daily or until MTD is reached, whichever comes first, for each schedule. GSK2110183 will continue at daily dosing until treatment discontinuation criteria is met.
16195733|NCT01428492|Drug|Bortezomib|Bortezomib (1.0 mg/m2) will be administered on days 1, 4, 8, and 11 of each 21-day cycle for cohort 1 for up to 8 cycles. Bortezomib (1.3 mg/m2) will be administered on days 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Bortezomib (1.5 mg/m2) will be administered on days 1, 8, and 15 of each 21-day cycle for up to 8 cycles.
16195734|NCT01428492|Drug|Dexamethasone|Dexamethasone will be given orally at a fixed dose of 20 mg only on days of bortezomib dosing in both Schedule A and Schedule B.
16195735|NCT01428479|Drug|GR121167 Solution|GR121167 solution will be administered intravenously. For 100 mg subject will receive 10 milliliter (mL) of solution, 30 mL for 300 mg and 60 mL for 600 mg
16195736|NCT01428479|Drug|Placebo|Placebo solution will be administered intravenously.
16195737|NCT01428466|Drug|GSK2585823|CLDM1%/BPO3%
16195738|NCT01428466|Drug|Benzoyl peroxide 3%|Benzoyl peroxide 3%
16195739|NCT01428466|Drug|Benzoyl peroxide 5%|Benzoyl peroxide 5%
16195740|NCT01428466|Other|Vehicle|placebo
16195741|NCT01428453|Drug|250mg rilapladib|Experimental Drug
16195742|NCT01428453|Drug|placebo|Placebo comparator
16195743|NCT01428440|Radiation|18FML10|apoptosis imaging radio ligand
16195744|NCT01428427|Drug|GSK1120212|Continuous daily oral dosing while on study or disease progression (cycle = 28 days).
16195745|NCT01428427|Drug|Gemcitabine|Dosing once weekly for 3 weeks in a 28 day cycle until disease progression.
16195746|NCT01428414|Drug|Trastuzumab|2 mg/kg, iv, d1,8,15(loading dose 4mg/kg wk1), qw
16195747|NCT01428414|Drug|Paclitaxel|75mg/m2, iv d1, 8,15. qw; 4-6 cycles
16195748|NCT01428414|Drug|Epirubicin|75mg/m2, iv d1, q3w, 4-6 cycles
16195749|NCT01428414|Drug|Carboplatin|AUC 2, qw, iv d1, 8,15. 4-6 cycles
16195750|NCT01428401|Drug|Chinese Herb Astragalus membranaceus|Astragalus membranaceus ( AM) at a rate of 3 g three times per day
16195751|NCT01428401|Other|Placebo|at a rate of 3 g three times per day
16195752|NCT01428388|Drug|Intravitreal injection of bevacizumab|1.25 mg per dose, delivered monthly by intravitreal injection for six months
16195753|NCT01428388|Drug|Intravitreal injection of ranibizumab (0.5 mg per dose)|0.5 mg per dose, delivered monthly by intravitreal injection for six months
16195754|NCT01428375|Drug|(1) Paracetamol injection|Drugs: (1) Bottle containing 1000 mg Paracetamol in 100 ml solution for intravenous infusion
16195755|NCT01428375|Other|Sterile water|Drugs: (2) Bottle containing 100 ml sterile water for intravenous infusion
16195756|NCT01428362|Drug|VI-1121|
16195757|NCT01428362|Drug|Placebo|
16195758|NCT01428349|Other|Cognitive Remediation|Computer training on 3 tasks that targets the attention to context deficits associated with psychopathic offenders. Participants complete 6 training sessions, that include the tasks, feedback and real-world translational examples.
16195759|NCT01428349|Other|Cognitive Remediation|Computer training on 3 tasks that targets the affective cognitive control deficits associated with externalizing offenders. Participants complete 6 training sessions, that include the tasks, feedback and real-world translational examples.
16195760|NCT01428336|Procedure|1 ug ACTH stimulation test|1 ug cortrosyn dose
16195761|NCT01428336|Procedure|250 ug ACTH stimulation test|ACTH stimulation test will be done using 250 ug cortrosyn dose
16195762|NCT01428336|Procedure|25 ug Cortrosyn stimulation test|ACTH stimulation test using a 25 ug cortrosyn dose
16195763|NCT01428336|Procedure|Insulin tolerance test|subjects will undergo an insulin tolerance test
16195764|NCT01428323|Device|Vented and Unvented Jet Nebulizer|Nebulizers used with 500mg aminoglycosides in 4ml until One minute after the sputerring point.
16195765|NCT01428310|Dietary Supplement|Anatabloc(TM)|one dissolvable bit, one time, after a period of abstinence from smoking
16195766|NCT01428310|Dietary Supplement|CigRx(R)|one dissolvable bit, one time, after a period of abstinence from smoking
16195767|NCT01428297|Drug|BPR277 ointment (controlled application)|
16195768|NCT01428297|Drug|Placebo (Vehicle)|
16195769|NCT01428297|Drug|BPR277 ointment|
16195770|NCT01428297|Drug|Placebo (Vehicle)|
16195771|NCT01428297|Drug|BPR277|
16195772|NCT01428297|Drug|Placebo (Vehicle)|
16195849|NCT01427660|Behavioral|Community Health Worker Diabetes Education: Print media|Providing information to patients about potential benefits, harms, costs, and burdens of medications and discussing patients' treatment preferences.
16195773|NCT01428284|Drug|Canagliflozin/Probenecid|Canagliflozin: Type = 1, unit = mg, number = 300, form = tablet, route = oral use. Probenicid: Type = 1, unit = mg, number = 500, form = tablet, route = oral use. One 300-mg canagliflozin tablet taken orally once daily on Days 1 to 14 (administration of canagliflozin alone) and on Days 15 to 17 (administration of canagliflozin + twice-daily administration of probenecid).
16195774|NCT01428271|Other|Ultrasonography|The confirmation of the real site of the sacral hiatus by ultrasonography
16195775|NCT01428258|Other|GMP Diet/GMP Medical Foods|The intervention consists of a low-phenylalanine (Phe) diet in combination with medical foods made with the peptide GMP supplemented with limiting indispensable amino acids, as provided by Cambrooke Therapeutics, LLC. The diet is formulated to replace the protein equivalents provided by AA medical foods with GMP medical foods, keeping other dietary components constant. The GMP dietary treatment period consists of all subjects following the GMP diet for 3-wks at home. The GMP diet intervention is administered in differing orders, GMP Diet/AA Diet or AA diet/GMP Diet.
16195776|NCT01428258|Other|AA Diet/AA Medical Foods|The intervention consists of a low-Phe diet in combination with commercial AA medical foods as consumed in each subject's usual diet. A total of 15 different commercial AA medical foods were consumed by subjects in the study. The diet is formulated to provide each subject with their typical daily intake of protein equivalents from AA medical foods. The AA dietary treatment period consists of all subjects following the AA diet for 3-wks at home. The AA Diet comparator intervention is administered in differing orders, GMP Diet/AA Diet or AA diet/GMP Diet.
16195777|NCT01428245|Drug|Progesterone|oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days
16195778|NCT01428245|Drug|Estrace (estrogen)|oral estrace, 0.5-1 mg once a day for seven days
16195779|NCT01428232|Other|implementation of the Baby-Friendly Hospital Initiative|Implementation of BFHI steps 1-9 in maternities
16195780|NCT01428232|Other|BFHI steps 1-9 +well-child clinic|Implementation of BFHI steps 1-9 in maternities and provision of breastfeeding support including culturally appropriate educational messages and metaphors as the ongoing aspect of step 10 in well-child clinic
16195781|NCT01428219|Drug|Cabozantinib|Cabozantinib is available in capsule form. The dose is 60 mg daily by mouth. Subjects with disease progression at 6 weeks who do not have significant toxicities may remain on therapy for an additional six weeks until a progression is confirmed. Further study drug administration beyond 12 weeks will be at the discretion of the investigator provided that the subject does not have disease progression, does not have unacceptable side effects, does not withdraw from study, or does not have a medical condition or illness that renders the subject unacceptable to receive further study drug.
16195782|NCT01428206|Other|Liverpool care pathway|Liverpool care pathway is started tha last day in life for elderly at nursing homes
16195783|NCT01428193|Drug|Flutamide|Subjects weighing > 50 kg will receive 250 mg orally twice a day, and subjects weighing < 50 kg will receive 125 mg orally twice a day.
16195784|NCT01428193|Drug|Progesterone|oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days
16195785|NCT01428193|Drug|estrace|0.5-1 mg once a day for seven days
16195786|NCT01428180|Drug|Indomethacin|3 doses of 0,2mg/kg every 12h (first week of life) or every 8h (after first week of life)
16195787|NCT01428180|Procedure|Surgical Ligation|In nonresponders to medical treatment with persistent hemodynamically relevant patent ductus arteriosus surgical ligation is performed.
16195788|NCT01428180|Drug|Ibuprofen|3 doses every 24h; first dose 10mg/kg, second and third dose 5mg/kg
16195789|NCT01428154|Drug|Darbepoetin alfa|A single 1.5 μg/kg subcutaneous (SC) dose administration on day 1
16195790|NCT01428141|Drug|E7050|Drug: E7050 The starting dose of E7050 will be 400 mg given orally, once-daily, in patients with advanced tumor that have progressed following effective therapy. The study consists of 2 parts: a Tolerability Confirmation Component to confirm the tolerable dose in subjects with solid tumor and an Expansion Component to confirm the safety and to preliminarily assess the anti-tumor activity in subjects with gastric cancer.
16195791|NCT01428128|Drug|Arsenic Trioxide|IV; 0.005mg/kg. Infusion on Days -3, -2 and -1 of Chemo Cycles 2, 4, and 6 (if more than 4 cycles received).
16195792|NCT01428089|Drug|Progesterone|Subjects will take 5-25 mg oral micronized P (based on body weight, to achieve mean plasma P 1-2 ng/ml) or placebo at 1100, 1500, and 1900 h.
16195793|NCT01428089|Drug|Placebo|Placebo
16195794|NCT01428076|Drug|Polidocanol Endovenous Microfoam (PEM)|Pharmacokinetic comparison of different doses of drug
16195795|NCT01428063|Drug|Daclatasvir|
16195796|NCT01428063|Drug|Asunaprevir|
16195797|NCT01428063|Drug|Pegylated interferon alfa-2a|
16195798|NCT01428063|Drug|Ribavirin|
16195799|NCT01428050|Drug|3% NaCl Solution|1cc/kg/hr of 3%NaCl + 9cc/kg/hr of lactated ringers solution
16195800|NCT01428050|Drug|Lactated Ringers Solution|15cc/kg/hr for intraoperative fluids
16195801|NCT01428037|Drug|Placebo|One tablet vaginal inserted at 4 hrly interval with maximum of three doses
16195802|NCT01428037|Drug|Misoprostol vaginal Tablet 25 mcg|One tablet vaginal insert at 4 hrly interval with maximum of three doses
16195803|NCT01428024|Device|Restylane Lip Volume|Treatment of up to 1,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12.
16195804|NCT01428024|Device|Restylane Lip Refresh|Treatment of up to 0,5 ml product for upper and lower lip, respectively at week 0 and optional at week 12.
16195805|NCT01427998|Dietary Supplement|olive leaf extract|olive leaf extract, 1 pill daily, 500 mg, for a duration of 14 wks
16195806|NCT01427998|Other|placebo|placebo
16195807|NCT01427985|Drug|Atropine, Fentanyl, Mivacurium|"Atropin 10µg/kg
~Mivacurium 200µg/kg immediately followed by
~Fentanyl 2µg/kg"
16195808|NCT01427985|Drug|Atropine, Fentanyl, Mivacurium|"Atropin 10µg/kg
~Fentanyl 2µg/kg, repeat max. two times
~Mivacurium 200µg/kg"
16195809|NCT01427972|Drug|LY2623091|Administered orally
16195810|NCT01427972|Drug|Eplerenone|Administered orally
16195811|NCT01427946|Drug|IPI-504|
16195812|NCT01427946|Drug|Everolimus|
16195813|NCT01427933|Biological|Ramucirumab (IMC-1121B)|Administered intravenously
16195814|NCT01427933|Drug|Eribulin|Administered intravenously
16195894|NCT01427270|Drug|Oxycodone/Naloxone controlled-release|Oxycodone/Naloxone controlled-release tablets (10/5 - 40/20 mg) taken orally every 12 hours
16195815|NCT01427920|Drug|biphasic insulin aspart 30|Administered subcutaneously (under the skin) using FlexPen® twice daily for 20 weeks. Directions for use were given to each subject at each dispensing visit. Subjects continued on their pre-trial metformin dose. Any previous basal insulin analogue and OAD (oral anti-diabetes drug) treatments (except for metformin) were discontinued.
16195816|NCT01427907|Drug|Calcium acetate oral solution (COS)|Each subject will undergo two separate treatment periods. Subjects will ingest either COS or sevelamer for 28 days (Treatment Period 1) and then switch to the other binder for 28 days (Treatment Period 2).
16195817|NCT01427907|Drug|Sevelamer carbonate|Each subject will undergo two separate treatment periods. Subjects will ingest either COS or sevelamer for 28 days (Treatment Period 1) and then switch to the other binder for 28 days (Treatment Period 2).
16195818|NCT01427894|Other|Maternal singing with Kangaroo Care|Maternal singing with Kangaroo Care
16195819|NCT01427881|Drug|cyclophosphamide|Given IV
16195820|NCT01427881|Drug|cyclosporine|Given IV
16195821|NCT01427881|Procedure|peripheral blood stem cell transplantation|Undergo allogeneic PBSCT
16195822|NCT01427881|Radiation|total-body irradiation|Undergo TBI
16195823|NCT01427881|Drug|fludarabine phosphate|Given IV
16195824|NCT01427881|Drug|busulfan|Given IV
16195825|NCT01427881|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo allogeneic PBSCT
16195826|NCT01427868|Drug|LB80380 maleate salt|183 mg (150 mg as a free base)
16195827|NCT01427868|Drug|LB80380 free base|150 mg
16195828|NCT01427855|Other|High saturated fat red meat diet|4 weeks of a high saturated fat red meat diet (38% carbohydrate; 25% protein (12% kcal from red meat protein); 37% fat (15% kcal from saturated fat))
16195829|NCT01427855|Other|High saturated fat non-meat diet|4 weeks of a high saturated fat non-meat diet (38% carbohydrate; 25% protein (16% kcal from non-meat protein); 37% fat (15% kcal from saturated fat))
16195830|NCT01427855|Other|High saturated fat white meat diet|4 weeks of a high saturated fat white meat diet (38% carbohydrate; 25% protein (12% kcal from white meat protein); 37% fat (15% kcal from saturated fat))
16195831|NCT01427855|Other|Low saturated fat red meat diet|4 weeks of a low saturated fat red meat diet (38% carbohydrate; 25% protein (12% kcal from red meat protein); 37% fat (7% kcal from saturated fat))
16195832|NCT01427855|Other|Low saturated fat white meat diet|4 weeks of a low saturated fat white meat diet (38% carbohydrate; 25% protein (12% kcal from white meat protein); 37% fat (7% kcal from saturated fat))
16195833|NCT01427855|Other|Low saturated fat non meat diet|4 weeks of a low saturated fat non-meat diet (38% carbohydrate; 25% protein (16% kcal from non-meat protein); 37% fat (7% kcal from saturated fat))
16195834|NCT01427842|Drug|DEVINE vancomycin regimen|The dosing regimen varies by weight and height and by initial or ongoing dose prescribed. The loading dose is based on actual volume of distribution of vancomycin whilst the ongoing doses are based on creatinine clearance.
16195835|NCT01427829|Behavioral|Computer-assisted Psychosocial Risk Assessment (CaPRA)|The study intervention was a touch-screen self-assessment survey which eligible patients completed on a touch-screen iPad in Dari/Farsi language while waiting to see their medical practitioner. The Computer-assisted Psychosocial Risk Assessment (CaPRA) survey had questions on psychosocial risks (e.g., alcohol, tobacco and street drug use, sexual health, personal violence, post-traumatic stress disorder, depression, and food insecurity), cardiovascular risks (e.g., physical activity, weight, diabetes, and hypertension), road and home safety, stress buffers (e.g., coping and social support) and sociodemographics. The tool generated two tailored print-outs at the point of care. The recommendation sheet for patients summarized their disclosed risks in simple Dari/Farsi language along with contacts of relevant services. The risk-report for medical practitioner summarized patients' risks with possible referrals. This was attached to the medical chart prior to the consult.
16195836|NCT01427816|Drug|KCT-0809|
16195837|NCT01427816|Drug|KCT-0809|
16195838|NCT01427816|Drug|Placebo|
16195839|NCT01427803|Drug|Naproxen Sodium ER (BAYH6689)|BAYH6689; oral tablet used as needed upon incidence of pain
16195840|NCT01427764|Device|manual and ultrasonic instruments|"The individuals were instructed regarding causes and consequences of periodontal disease as well as prevention techniques, including the sulcular brushing technique and flossing. The retention factors of plaque (caries cavities, excess supragingival restorations and calculus) were removed during the initial visits. Clinical parameters were initially assessed 30 days after initial therapy.
~The quadrants were randomly assigned and a total of 28 teeth were examined and treated. One side was treated with Gracey curettes (Hu-Friedy™ - Chicago, IL, USA) - control group and the other side with ultrasonic instruments (Profi II Ceramic™, Dabi Atlante - Ribeirão Preto, São Paulo, Brazil) - the test group, using the tip for subgingival instrumentation Perio Sub (Dabi Atlante ®)."
16195841|NCT01427751|Drug|dexamethasone intravitreal implant|Injection of Ozurdex® (dexamethasone intravitreal implant) into the study eye on Day 1 and Month 5. Patients may receive up to one additional treatment, thereafter.
16195842|NCT01427751|Biological|ranibizumab|Injection of Lucentis® (ranibizumab) into the study eye on Day 1 and monthly for five months. Patients will receive additional treatment thereafter based on re-treatment criteria.
16195843|NCT01427738|Drug|Gentian Violet|Participants were administered topical Gentian violet solution, orally, twice daily for 14 days.
16195844|NCT01427738|Drug|Nystatin oral suspension|Participants were administered Nystatin oral suspension 4 times a day for 14 days.
16195845|NCT01427699|Drug|T2-18C3 therapeutic antibody|1.25 mg/kg Intravenous infusion every 2 weeks for a total of 4 doses.
16195846|NCT01427686|Drug|Dobutamine|Start Dobutamine with 5µg/kg/min. Increase as needed until mean arterial pressure is in normal range (defined by responsible neonatologist, usually between gestational age in weeks and 10mmHg above this threshold) or until a maximum dose of 15µg/kg/min is reached. Only in the latter case switch to Dopamine.
16195847|NCT01427686|Drug|Dopamine|Start Dopamine with 5µg/kg/min. Increase as needed until mean arterial pressure is in normal range (defined by responsible neonatologist, usually between gestational age in weeks and 10mmHg above this threshold) or until a maximum dose of 15µg/kg/min is reached. Only in the latter case switch to Dobutamine.
16195848|NCT01427673|Procedure|Bipap procedure|Overlap patients randomized to Bipap titrated per AASM guidleines with an IPAP to EPAP diffrence of at least 8 cm H2O.
16195895|NCT01427270|Drug|Oxycodone HCl controlled-release|Oxycodone HCl controlled-release tablets (10 - 40 mg) taken orally every 12 hours
16195850|NCT01427660|Behavioral|CHW Diabetes Education: tailored web site|Providing tailored and interactive information to patients about potential benefits, harms, costs, and burdens of medications and discussing patients' treatment preferences.
16195851|NCT01427647|Procedure|Laparoscopic technique and thoracic epidural anesthesia|We have compared colorectal cancer surgery under two types of surgical(laparoscopic versus open) and anesthesia (thoracic epidural versus general) techniques
16195852|NCT01427634|Behavioral|Palliative Care|Receive ongoing counseling and symptom assessment as well as clarification and documentation of goals of care, starting before implantation and continuing throughout the course of the study. Intervention patients will also be followed by the inpatient palliative care consultation service when hospitalized for their initial VAD implantation and during any subsequent hospitalizations as needed
16195853|NCT01427634|Other|Usual Care|Receive usual care as provided by the VAD clinical team.
16195854|NCT01427621|Procedure|remote ischemic pre and postconditioning (RIPC)|RIPCcom group: combined intervention of remote ischemic pre- and postconditioning consisted of three 10-minute cycles of right lower limb ischemia, which was induced with an automated cuff-inflator placed on the right upper leg and inflated to 250 mmHg, with an intervening 10 minute of reperfusion during which the cuff was deflated. This intervention were performed at 10 minutes after induction of anesthesia and then 10 min after weaning from CPB.
16195855|NCT01427608|Drug|Sertraline + Olanzapine|Olanzapine 15mg/day. Adjustment of dose to 5mg/day to a maximum of 20mg/day will be permitted if necessitated by significant side-effects or clinical worsening
16195856|NCT01427608|Drug|Sertraline + Placebo|Taper from current dose of olanzapine to placebo over 4 weeks. Continue placebo for remainder of 36 week study.
16195857|NCT01427595|Drug|Metformin|500-2000 mg PO BID (X12 weeks)
16195858|NCT01427595|Drug|Progesterone|oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days (X2)
16195859|NCT01427595|Drug|estrace|oral estrogen (estrace, 0.5-1 mg once a day for seven days)- X2
16195860|NCT01427582|Drug|Trabectedin|Trabectedin i.v. formulation at a dose of 1.5 mg/m2 i.v. over 24 hours on Day 1 every 21 days
16195861|NCT01427569|Drug|IZN-6D4 Gel|Standard wound therapy plus twice weekly topical application of hydrogel containing botanical extracts.
16195862|NCT01427569|Other|Placebo hydrogel|Standard wound therapy plus twice weekly topical application of color-matched placebo hydrogel
16195863|NCT01427543|Behavioral|MILE intervention|Participants will be asked to attend 6 - 2 hour group sessions over the course of 3 weeks. The intervention aims to reduce HIV risk taking related to sex risk and alcohol and drug use.
16195864|NCT01427530|Device|Deep Brain Stimulation|Deep Brain Stimulation
16195865|NCT01427517|Drug|N-acetylcysteine|Single, intravenous administration of N-acetylcysteine
16195866|NCT01427504|Drug|boceprevir; etravirine|boceprevir tablets 800 mg, every 8 hours x 11-14 days. etravirine tablets 200 mg, every 12 hours x 11-14 days.
16195867|NCT01427491|Device|Aquacel® Ag|Dressing will be changed during the clinic visit on day 3, 7 and 14. In between the clinic visits the dressing should be changed when needed depending on the clinical condition of the wound and the volume of exudate.
16195868|NCT01427491|Device|Mepilex® Border Ag|Dressing will be changed during the clinic visit on day 3, 7 and 14. In between the clinic visits the dressing should be changed when needed depending on the clinical condition of the wound and the volume of exudate.
16195869|NCT01427478|Drug|AFATINIB|AFATINIBat the dose of 40 mg/during the 1st month and then 50 mg/d during the 11 following months
16195870|NCT01427478|Drug|Placebo of AFATINIB|placebo of Afatinib at the dose of 40 mg/during the 1st month and then 50 mg/d during the 11 following months
16195871|NCT01427465|Behavioral|Brief Prevention Program Using Positive Image|Consult
16195872|NCT01427465|Behavioral|Brief Prevention Program Using Positive Image|Control - Standard of Care
16195873|NCT01427465|Behavioral|Brief Prevention Program Using Positive Image|Newsletter
16195874|NCT01427465|Behavioral|Brief Prevention Program Using Positive Image|Parent Letter
16195875|NCT01427426|Dietary Supplement|All Greens|All Greens is a mixture of organic alfalfa powder, barley, wheat grass juice powder, lycopene, cranberry juice extract, rosehips, grapeseed phytosomes, soya extract, Acidophilus, bromelain, apple pectin, and other ingredients. All Greens is approved by Health Canada and available to the public for purchase.
16195876|NCT01427426|Other|Control Formulation|The Control Formulation is a rice-flour based product that has been designed to mimic the All Greens in appearance and taste.
16195877|NCT01427400|Drug|Botulinum Toxin-A|100 Units diluted in 25cc saline
16195878|NCT01427400|Drug|Saline|Dispensed in a 25cc syringe
16195879|NCT01427387|Drug|ASP0456|oral
16195880|NCT01427387|Drug|Placebo|oral
16195881|NCT01427348|Procedure|with assistant|head extension by an assistant during direct laryngoscopy
16195882|NCT01427348|Procedure|without assistant|without head extension by an assistant during direct laryngoscopy
16195883|NCT01427335|Drug|calcium|"intravenous infusion of 10 % calcium gluconate 10 mL in 200 mL of physiologic saline on the day of ovum pickup, day 1,day 2, and day 3 after ovum pickup were administered in study group.
~Intravenous infusion was performed within 30 minutes"
16195884|NCT01427335|Drug|0.9 % saline|0.9 % saline intravenous infusion
16195885|NCT01427322|Drug|Lapatinib|given orally 2-4 hours before first fraction of radiation therapy
16195886|NCT01427322|Radiation|Radiation therapy|Standard radiation therapy
16195887|NCT01427309|Biological|High Dose Trivalent Inactivated Influenza Vaccine|0.5 mL Intramuscular
16195888|NCT01427309|Biological|Trivalent Inactivated Influenza Vaccine|0.5 mL, Intramuscular
16195889|NCT01427296|Drug|Polyethylene glycol|HalfLytely and Bisacodyl Tablet Bowel Prep Kit, administered as 1 bisacodyl tablet followed by HalfLytely oral solution in a total liquid volume of approximately 2 L
16195890|NCT01427296|Drug|Oral sodium phosphate solution|OsmoPrep tablets (48 g), administered as 32 total tablets in a total liquid volume of approximately 2 L
16195891|NCT01427283|Drug|Oxycodone/Naloxone controlled-release|Oxycodone/Naloxone controlled-release tablets (10/5 - 40/20 mg) taken orally every 12 hours
16195892|NCT01427283|Drug|Oxycodone HCl controlled-release|Oxycodone HCl controlled-release tablets (10 - 40 mg) taken orally every 12 hours
16195893|NCT01427283|Drug|Placebo|Placebo tablets to match OXN or OXY taken orally every 12 hours
16195897|NCT01427257|Drug|Single Dose PB1023|Single Dose PB1023 Formulation A
16195898|NCT01427257|Drug|Single Dose PB1023|Single Dose PB1023 Formulation B
16195899|NCT01427257|Drug|Single Dose PB1023|Single Dose PB1023 Formulation B
16195900|NCT01427244|Drug|trastuzumab|monoclonal antibody
16195901|NCT01427231|Dietary Supplement|glucose|The effect of a glucose solution on cognitive performance will be measured.
16195902|NCT01427231|Dietary Supplement|sacharose|The effect of a sacharose solution on cognitive performance will be measured.
16195903|NCT01427231|Dietary Supplement|Placebo|The effect of a placebo drink with sweeteners on cognitive performance will be measured.
16195904|NCT01427218|Other|Titration of medications|Titration of medications for cholesterol, blood pressure, heart failure, and angina will occur. Cholesterol medications will be titrated according to labs at intervals nor more frequently than every 6 weeks until target LDL reached. Blood pressure (BP) medications will be titrated no more frequently than every 1-2 weeks until target BP reached. Heart failure medications will be titrated no more frequently than every 1-2 weeks until target doses reached or clinical status goals achieved. Anginal (chest pain) medications will be titrated no more frequently than every 1-2 weeks until control of chest pain occurs. Some patients will require more titrations than other patients (titration is patient specific).
16195905|NCT01427218|Behavioral|Lifestyle Counseling|The pharmacist will provide counseling on diet modification, smoking cessation, and physical activity
16195906|NCT01427218|Behavioral|Medication Counseling|The pharmacist will counsel the patient on adherence aids and medication safety and efficacy self and clinical monitoring.
16195907|NCT01427218|Other|Usual Care with Medication Reconciliation|A medication history and assessment of adherence will be completed by the pharmacist.
16195908|NCT01427205|Drug|Cetuximab|Loading dose 400 mg/m2 by vein once followed by 250 mg/m2 weekly (+/- 7 days).
16195909|NCT01427205|Drug|OSI-906|150 mg by mouth twice a day.
16195910|NCT01427205|Other|Placebo|Placebo taken by mouth twice daily.
16195911|NCT01427192|Drug|acetazolamide|250 mg bid
16195912|NCT01427192|Other|Supplemental oxygen|Oxygen deliverded by nasal cannula
16195913|NCT01427192|Procedure|Non-invasive ventilation|Bi-level non-invasive ventilation via nasal mask
16195914|NCT01427192|Other|Room air|Room air applied via sham oxygen concentrator
16195915|NCT01427192|Drug|Placebo tablet|Placebo tablet (Mannitol) similar to acetazolamide
16195916|NCT01427166|Other|Non invasive venous ultrasound|Subjects will undergo a venous duplex ultrasound, on a General Electric LOGIQ-9 unit with a Phillips-IU-22 probe
16195917|NCT01427153|Procedure|Orthopaedic manual physical therapy|OMPT consists of joint and soft-tissue mobilizations and the exercises that reinforce the manual techniques.
16195918|NCT01427153|Procedure|Corticosteroid Injection|Corticosteroid injection to the tibiofemoral joint
16195919|NCT01427140|Other|Polyunsaturated fatty acid group|Addition of polyunsaturated fatty acids to the diet in the form of pastries
16195920|NCT01427140|Other|Saturated fatty acid group|Addition of saturated fatty acids to the diet in the form of pastries
16195921|NCT01427127|Drug|Ramosetron|Patients received intravenous ramosetron 0.3 mg at end of surgery and 24hr after surgery.
16195922|NCT01427114|Drug|rituximab, cyclophosphamide, vincristine, and prednisolone|6 cycles of R-CVP followed by 2 cycles of rituximab
16195923|NCT01427088|Device|CR Technology, TAMAS for repetitive TMS|repetitive TMS, lef DLPFC, 20Hz, 100% of MEP, 2weeks
16195924|NCT01427075|Procedure|LATERAL PHARYNGOPLASTY|tonsilectomy and lateral pharyngoplasty
16195925|NCT01427062|Other|experimental|Subjects in the experimental group were trained the speed and amplitude of anticipatory postural adjustment during fall-prone activities and postural response to perturbation during walking. Training was provided with preparatory cues, computerized machines and treadmill.
16195926|NCT01427062|Other|control|Subjects in control group were provided with strength training of leg muscles using machines and during functional activities.
16195927|NCT01427049|Device|renal denervation|percutaneous selective renal sympathetic denervation with the use of the Symplicity Catheter system
16195928|NCT01427036|Procedure|MISS|"Installation of the patient in the operating room (same technique for MISS and PHS) operated supine on a fracture table, a fluoroscope (C Arm) authorizing a control AP and lateral.
~Reduction of the fracture before incision (same technique for MISS and PHS): it is essential for minimally invasive surgery and inclusion in the study. One checked on the AP and the lateral view the absence of a fracture gap greater than the thickness of the the cortical.
~skin incision 6 to 8 cm in the axis of the proximal femur, beginning a little above trochanteric crest in, then incised longitudinally extensive externe1 cm under the sub trochanteric crest, on a length of 3 cm. Passage of the raspatory along thefemoral shaft under the muscle on the entire length of the plate."
16195929|NCT01427036|Procedure|PHS|"Installation of the patient in the operating room (same technique for MISS and PHS) operated supine on a fracture table, a fluoroscope (C Arm) authorizing a control AP and lateral.
~Reduction of the fracture before incision (same technique for MISS and PHS): it is essential for minimally invasive surgery and inclusion in the study. One checked on the AP and the lateral view the absence of a fracture gap greater than the thickness of the the cortical.
~Surgical approach for PHS : Longitudinal external starting on trochanteric crest, long 15-20 cm depending on morphotype of the patient. Incision of the fascia latta like a  L  detaching the vastus lateralis to expose the external surface of the femur on the length of the plate."
16195930|NCT01427023|Device|APTIMA Trichomonas vaginalis (ATV) Assay|APTIMA Trichomonas vaginalis (ATV) Assay
16195931|NCT01427010|Radiation|[18F]FDG-PET-voxel intensity-based IMRT|Non-controlled, non-randomized, prospective study on 18F-Fluorodeoxyglucose-Positron Emission Tomography ([18F]FDG-PET)-voxel intensity-based intensity-modulated radiotherapy (IMRT) (dose painting) adapted to the anatomical and biological changes as detected by per-treatment FDG-PET/Computertomography (CT) acquired at the end of the 2nd and the 4th week of treatment.
16195932|NCT01426984|Drug|methylphenidate|a capsule containing 20 mg
16195933|NCT01426971|Drug|IBUPROFEN + CAFFEINE|Pharmaceutical form: capsule Route of administration: oral
16195934|NCT01426971|Drug|IBUPROFEN|Pharmaceutical form: capsule Route of administration: oral
16195935|NCT01426958|Drug|afatinib|standard therapeutic dose
16195936|NCT01426958|Drug|ritonavir + afatinib|simultaneous intake of ritonavir and afatinib on second treatment day
16195937|NCT01426958|Drug|ritonavir + afatinib|on the second treatment day the first ritonavir tablet will be taken 6 hours after the afatinib tablet
16195938|NCT01426945|Genetic|protein expression analysis|
16195939|NCT01426945|Other|immunohistochemistry staining method|
16195940|NCT01426945|Other|laboratory biomarker analysis|
16195941|NCT01426932|Other|Video recording of Head Impulse Test|Video recording of Head Impulse Test
16195942|NCT01426919|Other|Head CT scan and blood draw within 12 hours of injury|
16195943|NCT01426906|Drug|Ketoconazole|Period 1 : LC15-0444 Period 2 : LC15-0444 with ketoconazole
16195944|NCT01426906|Drug|rifampicin|Period 1 : LC15-0444 Period 2 : LC15-0444 with rifampicin
16195945|NCT01426880|Drug|Carboplatin|Carboplatin, AUC, 2 min/mL weekly, infusion
16195946|NCT01426880|Drug|background treatment|"background treatment according to standards fpr triple negative and Her2pos breast cancer patients Paclitaxel: 80 mg/m² i.v. given weekly on day 1 q day 8 for 18 weeks. NPLD (Myocet®): 20 mg/m² weekly on day 1 q day 8 for 18 weeks Trastuzumab (only for HER2-positive patients): Loading dose: 8 mg/kg, Maintenance dose: 6 mg/kg, day 1 q day 22 for 6 cycles. Post-surgery: up to a total duration of 1 year according to current AGO guidelines Lapatinib 750 mg/day p.o. continuously for 18 weeks; in case of good tolerability (no CTC grade II toxicity except alopecia and nausea/vomiting) during the first cycle the dose may be escalated to 1000 mg.
~Bevacizumab: 15 mg/kg i.v., day 1 q day 22 for 6 cycles (only in TNBC patients)."
16195947|NCT01426867|Drug|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension|
16195948|NCT01426867|Drug|Brinzolamide ophthalmic suspension, 1%|
16195949|NCT01426867|Drug|Brimonidine tartrate ophthalmic solution, 0.2%|
16195950|NCT01426854|Drug|Nepafenac Ophthalmic Suspension, 0.1%|Topical ocular administration
16195951|NCT01426854|Other|Nepafenac Vehicle Ophthalmic Solution|Inactive ingredients used as placebo; topical ocular administration
16195952|NCT01426841|Radiation|Adaptive Radiation|Thoracic Radiotherapy which is adapted or adjusted during its course to account for tumor volume shrinkage which occurs during treatment
16195953|NCT01426828|Biological|CD3/CD28|CD3/CD28 activated autologous lymphocytes intravenously
16195954|NCT01426815|Drug|Placebo|The prefilled syringe with placebo will be administrated subcutaneously every 4 weeks during a study period of 24 weeks.
16195955|NCT01426815|Drug|Golimumab|The prefilled syringe with golimumab 50mg (Simponi ®) will be administrated subcutaneously every 4 weeks during a study period of 48 weeks.
16195956|NCT01426802|Drug|vildagliptin|Drug 50mg vildagliptin bid
16195957|NCT01426789|Drug|Placebo|Matching placebo to secukinumab I.V.
16195958|NCT01426789|Drug|Secukinumab|In part 1 (blinded period), participants randomized to secukinumab received 10 mg/kg I.V.. Participants, enrolled in part 2 (open label), received secukinumab 300 mg subcutaneous.
16195959|NCT01426776|Procedure|heart valve replacement|The patients with heart valve disease and CSR will be received heart valve replacement
16195960|NCT01426763|Biological|CINRYZE with rHuPH20|
16195961|NCT01426750|Dietary Supplement|industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren|The oral and tube supplement offered was Nutren Jr® (for patients aged 1 - 9 years) or Nutren 1.0- Nestlé Clinical Nutrition-Brazil (for those aged 10 years or over). This supplement was a whole powder formulation that presented a macro composition of 52% carbohydrates, 12% proteins and 36% lipids. Its vitamins were A, D, E, K, B complex, biotin and choline; its trace elements were iron, copper, zinc, manganese, selenium, chromium and molybdenum; its macroelements were potassium, calcium, sodium, chlorine, iodine, magnesium and phosphorus; and it contained taurine and L-carnitine presenting 1.0 kcal/ml.
16195962|NCT01426737|Drug|Vildagliptin|Vildagliptin 50mg twice/d as add-on to metformin alone over 18 months compared to an add-on therapy with gliclazide 30mg max 4x/d(metformin - gliclazide).
16195963|NCT01426724|Drug|Contrast Enhanced Ultrasonography|Definity microbubbles will be infused intravenously at a rate of 2mL/min. contrast enhanced images of the kidneys will be obtained during the infusion and following the destruction of microbubbles within the kidney tissue with ultrasound to measure renal blood flow two times within a 90 day (plus or minus 10 day) window
16195964|NCT01426698|Procedure|delayed cord clamping|at birth, the obstetrical provider delays the cord clamping for 45 seconds while lowering the infant. At 45 seconds the cord is milked once and then clamped and cut.
16195965|NCT01426672|Other|Monovision Correction (with the help of glasses or contact lenses)|
16195966|NCT01426659|Behavioral|parental stimulation according to protocol|"verbal stimulation every day image of the Protocol Dire et Faire"
16195967|NCT01426646|Drug|S-1|S-1 was administered at 40mg/m2 orally twice daily (days 1-28) every 42 days. Patients received a maximum of eight cycles.
16195968|NCT01426646|Drug|S-1 plus cisplatin|"S-1 plus cisplatin every 3 weeks, a total of eight cycles
~S-1: 40mg/m2 orally twice daily (days 1-14)
~Cisplatin: 60mg/m2 IV on day 1"
16195969|NCT01426633|Drug|Gemcitabine + Trabectedin|Combination therapy of gemcitabine and trabectedin
16195970|NCT01426620|Dietary Supplement|Blueberry powder|The intervention consists of 2-3 packages (15 grams per package) of lyophilized blueberry powder, taken daily after mixing with natural yogurt, milk, water, or juice in combination with set dosage of docetaxel (35 milligrams per meter squared) administered intravenously every week for 4 cycles, 21-day cycles.
16195971|NCT01426607|Device|AMO|
16195972|NCT01426581|Behavioral|Teach-To-Goal|"Participants observe a demonstration on the use of each inhaler, with corresponding verbal step-by-step instructions (demonstration, verbal instruction), then participants 'teachback or re-demonstrate the steps; cycles are repeated are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions)"
16195973|NCT01426581|Behavioral|Brief Intervention|Participants are read step-by-step instructions (verbal instructions) for each respective inhaler (Metered Dose Inhaler +/- Diskus), and receive a copy of these instructions with images depicting the steps (written instructions)
16195974|NCT01426568|Behavioral|Multi-Convergent Therapy|Cognitive Behavioural Therapy Relaxation Techniques Meditation Stress Management
16195975|NCT01426555|Other|FES-Rowing|FES- Rowing Exercise
16195976|NCT01426555|Drug|Zoledronic acid|5 mg IV single dose
16195977|NCT01426542|Drug|Topiramate|Topiramate 5 mg/kg by mouth (or by feeding tube) once a day for one week before and one week after heart surgery.
16195978|NCT01426542|Other|No medication, but routine heart surgery|No medication, but routine heart surgery
16195979|NCT01426529|Drug|Para-aminohippuric Acid|"Aminohippurate sodium is an agent to measure effective renal plasma flow (ERPF). It is the sodium salt of para-aminohippuric acid, commonly abbreviated PAH."
16195980|NCT01426529|Drug|Angiotensin II|Angiotensin II (Ang II) is a naturally occurring hormone whose primary purpose is to regulate the body's internal volume. It accomplishes this task by influencing the function of a variety of organs and tissues. It increases aldosterone secretion from the adrenal gland. It causes blood vessels to contract, particularly renal blood vessels, and it modifies the way the heart works.
16195981|NCT01426529|Drug|Norepinephrine|A hormone that is normally present in your body, which regulates your blood pressure.
16195982|NCT01426516|Device|Genecept Assay|Genetic test which analyzes five pharmacodynamic and two pharmacokinetic genes important in psychiatric disorders
16195983|NCT01426490|Dietary Supplement|Vitamin C|Vitamin C, 100 mg/d
16195984|NCT01426490|Dietary Supplement|Vitamin B6|Vitamin B6, 50mg/d
16195985|NCT01426490|Dietary Supplement|Folic acid|Folic acid 400 microgram/d
16195986|NCT01426490|Dietary Supplement|Vitamin B6 plus folic acid|Vitamin B6, 50 mg; folic acid, 400 microgram
16195987|NCT01426464|Drug|0.005% Latanoprost dosed once.|0.005% Latanoprost dosed once. Placebo lotion dosed once.
16195988|NCT01426451|Other|Group tutoring program|Academic in-class intervention that focuses on differentiated academic instruction and improved overall academic adjustment. In each classroom assigned to the tutorship intervention, two academic resource assistants will provide weekly in-class support to students for the same length of time than the drama workshop (75 minutes, once a week), with the teacher present in the classroom.
16195989|NCT01426451|Other|Theatre workshops|The theatre expression workshops will run for 12 weeks, with one 75-minute workshop per week. They will be incorporated into the regular class timetable and will be run by the two members of the intervention team who have training in theatre and psychology, and the homeroom teacher, whose level of direct involvement will increase gradually as he or she becomes familiar with the workshops.
16195990|NCT01426438|Drug|Niacin|Extended-release niacin will be given with aspirin 325 mg by mouth in the evening and dose-escalated as follows: 500 mg once daily for 4 weeks, 1000 mg once daily for 4 weeks, then 1500 mg once daily for 16 weeks (through week 24)
16195991|NCT01426438|Drug|Aspirin|Aspirin 325 mg will be given by mouth in the evening with extended-release niacin through week 24.
16195992|NCT01426438|Drug|Fenofibrate|Fenofibrate will be administered as 200 mg by mouth once daily for 24 weeks.
16195993|NCT01426425|Device|Freezor Xtra Cryoablation Catheter|Freezor® Xtra Cardiac CryoAblation applied for cryoablation of the conducting tissues of the heart in the treatment of patients with atrioventricular nodal reentrant tachycardia using an endocardial approach.
16195994|NCT01426412|Drug|LY3015014 IV|Administered IV over 30-90 minutes
16195995|NCT01426412|Drug|Placebo IV|Administered IV only over 30-90 minutes
16195996|NCT01426412|Drug|LY3015014 SC|Administered SC
16195997|NCT01426412|Drug|Placebo SC|Administered SC
16195998|NCT01426399|Drug|LC15-0444|LC15-0444 50mg qd (8 days once daily)
16195999|NCT01426399|Drug|Metformin|Metformin 1000 mg bid (8 days twice daily)
16196000|NCT01426399|Drug|LC15-0444+Metformin|LC15-0444 50mg qd (8 days once daily) + Metformin 1000 mg bid (8 days twice daily)
16196001|NCT01426386|Drug|FE 999049|
16196002|NCT01426386|Drug|Gonal - F|
16196003|NCT01426373|Drug|Deoxycholic acid injection|Formulated as an injectable solution containing deoxycholic acid at a concentration of 10 mg/mL.
16196004|NCT01426360|Other|control dentifrice|use the dentifrice to brush teeth twice a day for one minute for 3 days
16196005|NCT01426360|Other|strontium chloride/potassium nitrate dentifrice|use the dentifrice to brush teeth twice daily for 3 days
16196006|NCT01426347|Drug|Placebo sugar pill|Intervention includes 1 sugar pill once a week for 16 weeks dispensed as a capsule.
16196007|NCT01426347|Drug|Ergocalciferol|Ergocalciferol 50,000 IU per week for 16 weeks
16196008|NCT01426334|Drug|dasatinib|Given PO
16196009|NCT01426334|Other|diagnostic laboratory biomarker analysis|Correlative studies
16196010|NCT01426334|Other|pharmacological study|Correlative studies
16196011|NCT01426334|Drug|cyclosporine|Given PO
16196012|NCT01426321|Other|Imaging guided LV lead positioning|"LV lead positioning guided by echocardiography (mechanical strain evaluation by speckle tracking) in combination with cardiac CT. A viable segment with the latest mechanical activation is targeted, and an appropriate optimal cardiac vein segment is then chosen using the CT images."
16196013|NCT01426295|Device|Caphosol|"The Caphosol ™ is a recently launched medical in France (2009). (source: laboratory EUSA Pharma ®)
~The product is an aqueous solution for mouthwash that comes in the form of a hyper-saturated mixture of calcium phosphate at neutral pH to reconstitute immediately before use.
~Each patient randomized to the treatment arms in the study will receive daily at least 4 (maximum 10) mouthwash Caphosol ™.
~The treatments are to begin preventive J1 to chemotherapy and continued until out of aplasia (ANC> 500/mm3), and / or mucositis grade 0."
16196014|NCT01426295|Drug|Bicarbonate de sodium|"Treatment of the early start on the day of conditioning and stop when the ANC> 500/mm3 and / or mucositis grade zero, provisional date of bone exceeded.
~Versylène: Method of administration: gargle made with a minute from 15 to 30 mL, 2-5 times a day, alternating with PAROEX ®."
16196015|NCT01426282|Other|no intervention|no intervention
16196016|NCT01426282|Other|health education|"15 minutes health education given by nurse according to  The Chinese Resident Meals Guide  , National Revision Committee of the Guidelines of Hypertension Prevention and Control in 2005 ,  Guidelines on Prevention and Treatment of Blood Lipid Abnormality in Chinese Adults  ,  Guideline for diagnosis and treatment of patients with chronic stable angina , Guideline for prevention and treatment overweight and obesity in chinese adults "
16196017|NCT01426269|Drug|Doxycycline|During phase 1 (baseline - week 12): Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads)), oral, one capsule daily in the morning During phase 1 (baseline - week 12) and phase 2 (week 12 - week 52): Oracea (doxycycline 40 mg USP (30 mg immediate release & 10 mg delayed release beads), oral, one capsule daily in the morning
16196018|NCT01426269|Drug|Metronidazole|During Phase 1: MetroGel 1% (metronidazole 1% gel), topical, apply a thin layer once daily to the affected area
16196019|NCT01426269|Drug|Placebo|During phase 2 (week 12 - week 52): placebo, oral, one capsule daily in the morning
16196020|NCT01426256|Dietary Supplement|Cholecalciferol|Bolus dose of 250,000 IU during hospitalization + maintenance dose of 50,000 IU vitamin D every other week to be initiated 3 months after bolus dose
16196021|NCT01426243|Biological|Yellow fever vaccination (STAMARIL)|Yellow fever vaccination (STAMARIL)
16196022|NCT01426243|Biological|Yellow fever vaccination (STAMARIL)|Yellow fever vaccination (STAMARIL)
16196023|NCT01426217|Device|Passive Bundle PSI (Problem Solving Innovations) Medical HubScrub, PSI Medical DocIt|Implementation of passive bundle which includes HubScrub and DocIt device into the operating room environment.
16196024|NCT01426191|Drug|xinzhijun|"durg:Cefotaxime sodium and sulbactam sodium for injection(2:1)
~1.5-3.0g,iv,bid or tid for 5-12 days;
~Serious infections:1.0-1.5g,iv,tid or qid for 5-12 days"
16196025|NCT01426178|Device|Neurally Adjusted Ventilatory Assist in Non Invasive Ventilation (Device)|"After written information and consent, patients are randomised in two groups: NAVA first or PSV first.
~They receive a NAVA catheter, which has exactly the same appearance as a standard naso-gastric catheter."
16196026|NCT01426165|Drug|Magnesium Sulfate|8 grams over 4 or 8 hours depending on randomization
16196027|NCT01426139|Device|Percutaneous Coronary Intervention Biotronik Orsiro DES|Stenting
16196028|NCT01426126|Drug|Genexol PM|Genexol-PM at a dose of 240 mg/㎡ was diluted in 500 ml of 5% dextrose solution and infused i.v. for 3 hours on day 1. Specialized i.v. infusion sets or in-line filter was not required for the administration. The dose of Genexol-PM was escalated to 300 mg/㎡ from the second cycle when pre-specified criteria were fulfilled (nadir ANC ≥ 1,000/ mm3, nadir platelet count ≥ 100,000/ mm3, and no grade 2 or worse non-hematologic toxicities with the exception of alopecia)
16196029|NCT01426113|Drug|bimatoprost ophthalmic solution formulation A|1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the evening for 6 weeks, followed by 1 drop of bimatoprost ophthalmic solution formulation A in the affected eye(s) in the morning for 6 weeks.
16196030|NCT01426113|Drug|timolol ophthalmic solution|1 drop timolol ophthalmic solution in the affected eye(s) in the morning and evening for 12 weeks.
16196031|NCT01426113|Drug|bimatoprost vehicle|1 drop of bimatoprost vehicle in the affected eye(s) in the morning for 6 weeks, followed by 1 drop of bimatoprost vehicle in the affected eye(s) in the evening for 6 weeks.
16196032|NCT01426100|Drug|CKD-828 40/2.5mg|Fixed dose combination of Telmisartan 40mg and S-Amlodipine 2.5mg
16196033|NCT01426100|Drug|CKD-828 40/5mg|Fixed dose combination of Telmisartan 40mg and S-Amlidioine 5mg
16196034|NCT01426100|Drug|Telmisartan 80mg|Telmisartan 80mg monotherapy
16196035|NCT01426087|Drug|Somatostatin|giving stilamin 250ug/h after endoscopic therapy for 5 days
16196036|NCT01426087|Procedure|endoscopic therapy|gastroscope plus EIS/EVL/HI
16196037|NCT01426074|Drug|Bevacizumab 5 mg/kg|Intravenously every two weeks
16196038|NCT01426061|Other|Reflexology plus conventional treatment|Patients in the reflexology group received reflexology treatment in addition to usual care of asthma.Patients received treatments weekly for four to six weeks, followed by two treatments for one month. Treatments were then given monthly until the end of the study.
16196039|NCT01426061|Other|Homeopathy plus conventional treatment|Patients in the homeopathy group received homeopathic treatment in addition to usual care of asthma.Homeopathic treatment was decided on an individual basis by the homeopath and prescribed as an oral treatment. Patients received homeopathic product with potency between C30 (dilution by a factor 10030 =1060) and M10 (dilution by a factor 100010 =1030). The number of homeopathy sessions attended was six to twelve during one year.
16196040|NCT01426061|Other|Conventional treatment|Patients in the conventional treatment group received usual care of asthma. This treatment was monitored and adjusted as usual by the patient's general practitioner.
16196041|NCT01426048|Other|Gynaecological examination and a supine stress test, questionnaires|Gynaecological examination and a supine stress test, questionnaires
16196042|NCT01426035|Drug|TOPIC MUCOPOLYSACCHARIDE POLYSULFATE CREAM 5MG/G|APLIED 4 TIMES/DAY AT LESION
16196043|NCT01426022|Other|Nutrition|Moderate alcohol consumption with dinner (3 glasses of sparkling white wine, containing ca. 30 g alcohol)
16196044|NCT01426022|Behavioral|mood manipulation|Mood will be manipulated by changing the ambiance in either a pleasant or unpleasant way.
16196045|NCT01426009|Drug|EP-101 via nebulizer (eFlow®) 25 ug|EP-101 (25 ug ) Dose 1 administered once daily for 7 days
16196046|NCT01426009|Drug|EP-101 via nebulizer (eFlow®) 50 ug|EP-101 (50 ug ) administered once daily for 7 days
16196047|NCT01426009|Drug|EP-101 via nebulizer (eFlow®) 100 ug|EP-101 (100ug) administered once daily for 7 days
16196048|NCT01426009|Drug|Placebo EP-101|Placebo EP-101 administered once daily for 7 days
16196049|NCT01426009|Drug|Tiotropium bromide via (Spiriva® Handihaler®)|Tiotropium 18 µg administered once daily for 7 days using Handihaler® DPI
16196050|NCT01426009|Drug|Ipratropium bromide Inhalation Solution via Handihaler® DPI|Ipratropium 500 µg administered three times daily for 7 days using general purpose nebulizer
16196051|NCT01426009|Drug|EP-101 via nebulizer (eFlow®) 200 ug|EP-101 (200) ug administered once daily for 7 days
16196052|NCT01425996|Drug|Lipotecan® (TLC388)|"Cohort A1: TLC388 15 mg/m2 x 6 dose + 3DCRT
~Cohort A2: TLC388 30 mg/m2 x 6 dose + 3DCRT
~Cohort A3: TLC388 40 mg/m2 x 6 dose + 3DCRT
~Cohort A4: TLC388 50 mg/m2 x 6 dose + 3DCRT (dose-escalation)
~Cohort Ax: TLC388 MTD x 6 dose + 3DCRT"
16196053|NCT01425983|Dietary Supplement|amino acid composition (asn01)|"Amino acid composition with micronutrients, once a day (in the evening, 2 hours after dinner) content of a sachet mixed with 200 ml water.
~Duration: 12 weeks"
16196054|NCT01425983|Other|Placebo|"Placebo; once a day (in the evening, 2 hours after dinner) content of a sachet mixed with 200 ml water.
~Placebo contains no amino acids and micronutrients and is identical in appearance and solution properties.
~Duration: 12 weeks"
16196055|NCT01425970|Drug|INX-08189|Tablet, Oral, 25 mg, Once daily (QD), 12 weeks
16196056|NCT01425970|Drug|INX-08189|Tablet, Oral, 50 mg, Once daily (QD), 12 weeks
16196057|NCT01425970|Drug|INX-08189|Tablet, Oral, 100 mg, Once daily (QD), 12 weeks
16196058|NCT01425970|Drug|Placebo matching with INX-08189|Tablet, Oral, 0 mg, Once daily (QD), 12 weeks
16196059|NCT01425970|Biological|Pegylated interferon alfa-2a|Syringe, Subcutaneous injection, 180 μg, Once per week, 12 weeks
16199527|NCT01398449|Radiation|Elective nodal irradiation (ENI)|
16196060|NCT01425970|Drug|Ribavirin|Tablet, Oral, 500 or 600 mg weight dependent, Twice daily (BID), 12 weeks
16196061|NCT01425970|Drug|INX-08189|Tablet, Oral, 200 mg, QD, 12 weeks
16196062|NCT01425970|Drug|Daclatasvir|Tablet, Oral, 60 mg, QD, 12 weeks
16196063|NCT01425957|Procedure|Lumbar puncture|"All the patients will be divided in two groups based on their Aβ 1-42 levels measured in the cerebro-spinal fluid obtained form a lumbar puncture: in low Aβ1-42 (positive aMCI patients CSFP) and high Aβ1-42 (Negative aMCI patients CSFN). The threshold of Aβ1-42 used to divide the patient will be 500 (ng/L) based on Sjogren criteria (2001).
~Timeframe of lumbar punctures: every 18 months during 2 years (T0 and T18) or 3 years (T0, T18 and T36)."
16196064|NCT01425931|Procedure|Heart Lung machine|measurement of microcirculation with O2C device
16196065|NCT01425918|Behavioral|Social Enhancement Intervention|The intervention will be conducted at our center and focuses on providing an invigorating learning environment in which emerging social skills/knowledge are the focus of intervention with the aim of bringing them to a higher level of maturity, integrated with existing abilities, and used functionally. Learning with and through peers, provides the opportunity to address abnormal peer relationships for developmental level. Providing an enriched environment with toys, structured learning, and opportunities for ongoing engagement we offer the children robust learning experiences. Parent training sessions will focus on strategies aimed at improving child social engagement and communication.
16196066|NCT01425918|Behavioral|Parent Education|Parent education sessions will focus on topics related to autism, learning styles, interventions, and resources. The curriculum provides parents with information about child development and autism as well as instructional strategies (e.g., responsive teaching strategies, principles of applied behavior analysis) for use at home to enhance their children's communication, engagement, and play development. Concrete examples for home-based implementation are presented. Each week, homework will be given and parents will be encouraged to practice the strategies daily at home. No direct coaching to parents during interaction with their children or direct intervention with the child will be provided.
16196067|NCT01425905|Other|The Blues Program|
16196068|NCT01425905|Other|Hey Durham|
16196069|NCT01425879|Drug|Akt Inhibitor MK2206|Given PO
16196070|NCT01425879|Other|Diagnostic Laboratory Biomarker Analysis|Correlative studies
16196071|NCT01425879|Other|Pharmacological Study|Correlative studies
16196072|NCT01425866|Behavioral|Structured self-management group education during 2 years|After an initial intensive group education, four-monthly follow-up self-management group education sessions for 2 years. Each session is based on empowerment, socio-constructivism, social learning theory: personalized assessment (BG and risk factors, actions: realized, planned, achieved (or not), cognitive work, analysis of individual and social context and environment (facilitators, obstacles) then action planning. Specific additional sessions can be scheduled (food management, diabetes treatment and hypoglycemia, exercise, self monitoring of BG, insulin dosage, foot care). Sessions are framed, and structured, with patient booklet support. Sessions are delivered at the community level, by trained registered nurses, under the coordination of the health management network Reucare.
16196073|NCT01425853|Drug|Chondroitin/Glucosamine (Droglican)|Experimental
16196074|NCT01425853|Drug|Celecoxib|Active comparator
16196075|NCT01425840|Drug|Lidocaine|100 mg of the following formulations: Liposome-encapsulated 2,5% and 5% lidocaine gel, liposome placebo gel and 2.5% lidocaine and 2.5% prilocaine cream were applied once during 5 minutes.
16196076|NCT01425827|Drug|duloxetine HCL|60 mg/day duloxetine for 16 weeks
16196077|NCT01425827|Drug|placebo|similar looking tablets to the active agent for 16 weeks
16196078|NCT01425814|Drug|LAS100977|Dry powder inhalation,Once daily, single dose
16196079|NCT01425814|Drug|LAS100977|Dry powder inhalation,Once daily, single dose
16196080|NCT01425814|Drug|LAS100977|Dry powder inhalation,Once daily, single dose
16196081|NCT01425814|Drug|LAS100977|Dry powder inhalation,Once daily, single dose
16196082|NCT01425814|Drug|Reference|Dry powder inhalation (capsule),single dose
16196083|NCT01425814|Drug|Placebo|Dry powder inhalation or Dry powder inhalation (capsule),Once daily, single dose
16196084|NCT01425801|Drug|LAS100977 0.313 μg|Dry powder inhalation, once-daily, single-dose
16196085|NCT01425801|Drug|LAS100977 0.625 μg|Dry powder inhalation, once-daily, single-dose
16196086|NCT01425801|Drug|LAS100977 1.25 μg|Dry powder inhalation, once-daily, single-dose
16196087|NCT01425801|Drug|LAS100977 2.5 μg|Dry powder inhalation, once-daily, single-dose
16196088|NCT01425801|Drug|Salbutamol 400 μg|Pressurized inhalation suspension, once-daily, single-dose
16196089|NCT01425801|Drug|Salbutamol placebo|Pressurized inhalation, once-daily
16196090|NCT01425801|Drug|LAS100977 placebo|Dry powder inhalation, once-daily
16196091|NCT01425788|Biological|Osiris Phleum pratense|
16196092|NCT01425788|Biological|Osiris Phleum pratense|
16196093|NCT01425788|Biological|Osiris Phleum pratense|
16196094|NCT01425775|Drug|vitamin D 25(OH)D|2000IU/day for 12 months
16196095|NCT01425775|Other|Placebo|2000IU/day of vitamin D will be compared to similar looking tablets of placebo for 12 months
16196096|NCT01425762|Other|Drug Dose|100 versus 200 mcg IT morphine
16196097|NCT01425749|Biological|recMAGE-A3 + AS15 ASCI|Injections of recMAGE-A3 + AS15 ASCI will be given 5 times at 3-week intervals. This will either be administered cutaneously or intramuscularly depending on the study group. The injected doses will be administered in alternating extremities at each visit.
16196098|NCT01425736|Drug|Chemotherapy|Chemotherapy :Docetaxel(75mg/m²,1 time/21d, 6times);Cisplatin(75mg/m²,1 time/21d, 6 times);Fluorouracil(750mg/m²/d,5times/21d, 30times)
16196099|NCT01425736|Drug|Nimotuzumab and Chemotherapy|"Nimotuzumab treatment:(200mg/w,18weeks );
~Chemotherapy treatment:(Docetaxel(75mg/m²,1 time/21d, 6times);Cisplatin(75mg/m²,1 time/21d, 6 times);Fluorouracil(750mg/m²/d,5times/21d, 30times)Nimotuzumab treatment:(200mg/w,18weeks );"
16196100|NCT01425723|Biological|rFIXFc|Administered as specified in the treatment arm.
16196101|NCT01425697|Other|2% Chlorhexidine Gluconate cloths|2% chlorhexidine Gluconate wipes will bw used 12 hours prior to cardiac surgery and then again 3 hours prior to cardiac surgery. Subjects will be randomized to either receive a preoperative phone call reminder or no phone call reminder.
16196151|NCT01425307|Drug|Hydroxyurea|Capsules (300 mg, 400 mg, or 500 mg) taken once daily liquid formulation (100 mg/mL)
16196102|NCT01425697|Other|Standard of Care preoperative preparation.|Preoperative standard of care preparation utilized at the clinical site will be used. Subjects will be randomized to either receive a preoperative phone call reminder or no phone call reminder.
16196103|NCT01425658|Drug|distilled water|The placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally .
16196104|NCT01425658|Drug|Clonidine|The clonidine group (group C) received bupivacaine 10mg combined with 75 microgram clonidine intrathecally .
16196105|NCT01425658|Drug|Fentanyl|The Fentanyl group (group F) received bupivacaine 10mg combined with 25 microgram fentanyl intrathecally .
16196106|NCT01425645|Other|FDD program|FDD is a 12 month lifestyle intervention and behavioural support program delivered in the context of the surrounding family
16196107|NCT01425632|Drug|TAU-284|TAU-284 Low
16196108|NCT01425632|Drug|TAU-284|TAU-284 High
16196109|NCT01425632|Drug|Placebo|Placebo
16196110|NCT01425619|Biological|Cream of Macrogol cetostearyl ethers|The cream will be applied on the volar aspect of both arms for 1 hour
16196111|NCT01425619|Drug|Cream of Lidocaine 2.5 %.and Prilocaine 2.5 %|1-2 gr. of the cream will be applied on the volar aspect of the second arm; for 1 hour
16196112|NCT01425619|Behavioral|Care and treatment from a medical clown|Medical clown will entertain the children before, during and after performing the skin test. Placebo cream will be applied on both arms.
16196113|NCT01425619|Behavioral|Care and treatment from a medical clown|Medical clown will entertain the children, placebo cream will be applied on one arm and anesthetic cream on the second arm
16196114|NCT01425606|Other|blood test|blood test to measure levels of: sodium, albumin and acid - base status in venous blood.
16196115|NCT01425580|Drug|liraglutide|1.8 mg s.c. (QD)
16196116|NCT01425580|Drug|glimepiride|4 mg p.o. (QD)
16196117|NCT01425580|Drug|Metformin|500 mg p.o. (BID)
16196118|NCT01425567|Drug|Intravenous Lipid Emulsion Comprised of Fish Oil|IV lipid provided for parenteral nutrition when enteral feeds are not tolerated due to intestinal disease
16196119|NCT01425554|Other|Doppler sonography of internal jugular veins|Doppler sonography of internal jugular veins
16196120|NCT01425554|Other|Magnetic resonance venography of internal jugular veins|Magnetic resonance venography of internal jugular veins
16196121|NCT01425554|Other|Air-plethysmography of the neck|Air-plethysmography of the neck
16196122|NCT01425554|Other|Catheter venography of internal jugular veins|Catheter venography of internal jugular veins
16196123|NCT01425541|Drug|estrace|0.5-1 mg once a day PO for 7 days
16196124|NCT01425541|Drug|Progesterone|20 mg/ml, 25-100 mg, Three times a day at 0700, 1500, and 2300 hr for 7 days
16196125|NCT01425528|Drug|Sapropterin|Sapropterin will be taken daily for 12 or 24 weeks. Starting dose will be 20mg/kg/day and will increase at the 8 week visit to 30 mg/kg/day. Dosing may be further increased to as high as 40 mg/kg/day in attempt to normalize BH4 levels in CSF. Starting dose for Cohort 2 will be determined from data analysis in Cohort 1.
16196126|NCT01425515|Behavioral|Complex quality improvement intervention|We are implementing a complex quality improvement intervention that includes changes in practice processes to enhance hypertension care, provision of home blood pressure monitors to patients, and telephone coaching around hypertension self-management.
16196127|NCT01425502|Behavioral|DQIP Intervention|"The DQIP intervention comprises of:
~Educational outreach
~Information technology application
~Financial incentives"
16196128|NCT01425476|Drug|Celecoxib|Take one tablet from each bottle (one bottle containing either placebo/celecoxib and one bottle containing either cholecalciferol 400 IU or 2,000 IU) daily for 30 days.
16196129|NCT01425476|Drug|Placebo|Take one tablet from each bottle (one bottle containing either placebo/celecoxib and one bottle containing either cholecalciferol 400 IU or 2,000 IU) daily for 30 days.
16196130|NCT01425476|Drug|Cholecalciferol|Take one tablet from each bottle (one bottle containing either placebo/celecoxib and one bottle containing either cholecalciferol 400 IU or 2,000 IU) daily for 30 days.
16196131|NCT01425463|Drug|Ferrous (II) Glycine Sulphate Complex|"Oral dose of 567.7 mg Ferrous (II) Glycine Sulphate Complex three times a day (t.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).
~Administered orally with water."
16196132|NCT01425463|Drug|Polyferose|"Oral dose of 150 mg Polyferose Capsules twice daily (b.i.d) for 12 weeks (equivalent to 300 mg iron element per day for 12 weeks).
~Administered orally with water."
16196133|NCT01425463|Other|Placebo to Ferrous (II) Glycine Sulphate Complex|Administered orally with water.
16196134|NCT01425463|Other|Placebo to Polyferose|Administered orally with water.
16196135|NCT01425450|Drug|HF1020|Single doses at 0.5 mg capsules, 2.5 mg capsules, 10 mg capsules, and 25 mg capsules in each of cohorts 1, 2, 3 and 4 respectively.
16196136|NCT01425450|Drug|HF1020 placebo|Single dose: HF1020 placebo capsule
16196137|NCT01425424|Other|Vitamin D supplementation|Vitamin D
16196138|NCT01425411|Drug|valsartan|80/160 mg dosage of valsartan or 160+12,5 mg valsartan+hydrochlorothiazide combination, once a day, for six months
16196141|NCT01425385|Other|Near infrared spectroscopy monitoring|This is an observational study without interventions
16196142|NCT01425385|Other|Autoregulation monitoring|There are no interventions in this observational study
16196143|NCT01425359|Drug|Ranolazine|
16196144|NCT01425359|Drug|Ranolazine placebo|
16196145|NCT01425333|Procedure|Surgery for ovarian endometrioma|Patients undergoing surgery for ovarian endometrioma
16196146|NCT01425333|Procedure|Surgery for ovarian endometrioma|Patients undergoing surgery for ovarian endometrioma
16196147|NCT01425320|Drug|Fixed Combination dapsone/adapalene Formulation A Gel|Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.
16196148|NCT01425320|Drug|Fixed Combination dapsone/adapalene Formulation B Gel|Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.
16196149|NCT01425320|Drug|dapsone 5% gel|Study medication will be applied twice daily for 14 days to the face, upper chest, upper back, and shoulders.
16196150|NCT01425320|Drug|adapalene 0.3% gel|Study medication will be applied once daily for 14 days to the face, upper chest, upper back, and shoulders.
16196152|NCT01425281|Device|Abbott Vascular XIENCE Everolimus Eluting Coronary Stent System|XIENCE implantation in the treatment of coronary artery disease.
16196153|NCT01425281|Device|Abbott Vascular ABSORB Everolimus Eluting Bioresorbable Vascular Scaffold System|ABSORB BVS implantation in the treatment of coronary artery disease.
16196154|NCT01425268|Device|AeroForm Tissue Expansion|The AeroForm Patient Controlled Tissue Expander is a breast tissue expander implanted following mastectomy and activated by remote control to release small doses of carbon dioxide from an internal reservoir to fill and inflate the expander.
16196155|NCT01425268|Procedure|Saline Tissue Expansion|A saline tissue expander is a breast tissue expander which is implanted following mastectomy and inflated over time using needle injections to fill and inflate the expander with saline.
16196156|NCT01425242|Drug|Aliskiren|Starting dose: Aliskiren 150 mg p.o, if hypertension is insufficiently treated Hydrochlorothiazide 12.5 mg p.o. tablet once daily for maximally 12 months can be added, the next step is to add increase the dosage of Aliskiren to 300 mg p.o. tablet once daily until maximally 12 months after baseline, the final step to take in case hypertension is still present is to increase Hydrochlorothiazide to 25 mg p.o. tablet once daily until maximally 12 months after baseline.
16196157|NCT01425242|Drug|Amlodipine|Starting dose: amlodipine 5 mg p.o, if hypertension is insufficiently treated Hydrochlorothiazide 12.5 mg p.o. tablet once daily for maximally 12 months can be added, the next step is to add increase the dosage of amlodipine to 10 mg p.o. tablet once daily until maximally 12 months after baseline, the final step to take in case hypertension is still present is to increase Hydrochlorothiazide to 25 mg p.o. tablet once daily until maximally 12 months after baseline.
16196158|NCT01425229|Drug|Bosentan|"Administration of bosentan: 1 x 125 mg p.o. on day 1, 2 x 125 mg p.o. on day 2-14
~Administration of clarithromycin: 2 x 500 mg p.o. on day 11-14"
16196159|NCT01425216|Drug|Sorafenib|Treatment will be administered on an outpatient basis. All patients will keep a drug diary in order to record compliance with their drug regime. Sorafenib will be taken orally. Maximum length of treatment is 6 months. Starting dose of sorafenib is 200 mg three times per week for one month. In absence of Grade 2 toxicity, the dose will be increased on a monthly basis and will stop at 400 mg twice daily.
16196160|NCT01425203|Drug|Boceprevir|boceprevir 200-mg capsules, 800 mg 3 times a day (TID), orally (PO)
16196161|NCT01425203|Drug|Placebo|boceprevir-matched placebo four 200-mg capsules PO TID.
16196162|NCT01425203|Biological|peginterferon alfa-2b|peginterferon alfa-2b 1.5 μg/kg/wk subcutaneously (SC)
16196163|NCT01425203|Drug|Ribavirin|ribavirin (weight-based dosing) 800 to 1400 mg/day PO divided twice daily dose (BID).
16196164|NCT01425190|Drug|Boceprevir|Single dose of boceprevir powder prior to breakfast in a dosing vehicle of chocolate pudding (i.e., a mousse or custard), apple sauce, Nutella, fruit pudding such as strawberry, cherry, or raspberry pudding, or yogurt or a similar semi-solid product into which the boceprevir powder can be evenly stirred
16196165|NCT01425177|Procedure|Normal Saline Irrigation|After removing CBD stones with the ERCP, 200ml of the normal saline solution was irrigated into the common bile duct.
16196166|NCT01425164|Drug|Ivabradine|ivabradine tablets, 5 to 7.5 mg bis-in-die.
16196167|NCT01425164|Drug|Carvedilol|carvedilol tablets, 12.5 to 25 mg bis-in-die.
16196168|NCT01425151|Device|i-Gel|Oropharyngeal leak pressure Insertion success
16196169|NCT01425151|Device|ProSeal|Oropharyngeal leak pressure Insertion success
16196170|NCT01425125|Drug|Tolvaptan in euvolemic hyponatremia|This arm will test the effectiveness of tolvaptan in treating the hyponatremia of patients with euvolemic hyponatremia.
16196171|NCT01425112|Procedure|Phacoemulsification|Surgery for complications of trabeculectomy
16196172|NCT01425099|Drug|Dolutegravir|Dolutegravir is an experimental drug in the integrase inhibitor class for the treatment of HIV.
16196173|NCT01425099|Drug|Prednisone|Prednisone is a commonly used corticosteroid used for a variety of medical condiitons
16196174|NCT01425086|Device|Embrace, PCM, warming blanket|"Infant will be placed on a blanket that encloses the Embrace device, The infant will be wrapped in this blanket to create a snug, comfortable and warm micro-environment."
16196175|NCT01425073|Other|Discontinue TMP/SMZ prophylaxis|Subjects in the intervention arm will discontinue use of daily TMP/SMZ for the duration of the study
16196176|NCT01425060|Behavioral|Contraceptive management program|The contraceptive management program will consist of two components: (1) the World Health Organization's contraception protocol and (2) reinforced follow-up visits.
16196177|NCT01425060|Other|Usual care|The usual care condition will be given general information about contraceptive options and contact information for clinics and providers that provide contraceptive services.
16196178|NCT01425034|Other|casts for the thumb|The 'Cast' group will be placed in a thumb spica short arm cast with the thumb IP joint free. They will be allowed digit, thumb IP and elbow range of motion.
16196179|NCT01425034|Other|Motion group|The 'Motion' group will be placed in a forearm based thumb spica splint with the thumb IP free. They will be allowed digit, thumb IP and elbow range of motion.
16196180|NCT01425008|Drug|MLN2480|Dose Escalation Phase: participants will receive MLN2480 orally in escalating doses every other day or once weekly for three weeks of a 28-day cycle. Participants may continue treatment for additional cycles (up to 12 months) until disease progression, unacceptable toxicity, or the participant discontinues for any other reason. If it is determined that a participant would derive benefit from continued therapy beyond 12 months treatment may continue. Dose Expansion Phase: Participants will take MLN2480 at the maximum tolerated dose orally every other day or once weekly for three weeks of a 28-day cycle until disease progression, unacceptable toxicity, or the participant discontinues for any other reason. The maximum duration of treatment is 1 year unless determined that a participant would derive benefit from continued therapy beyond 12 months.
16196181|NCT01424982|Drug|Cyclophosphamide|Given IV
16196182|NCT01424982|Drug|Cytarabine|Given IV
16196183|NCT01424982|Drug|Dexamethasone|Given IV or PO
16196184|NCT01424982|Drug|Doxorubicin|Given IV
16196185|NCT01424982|Drug|Doxorubicin Hydrochloride|Given IV
16196186|NCT01424982|Other|Laboratory Biomarker Analysis|Correlative studies
16196187|NCT01424982|Drug|Methotrexate|Given IV
16196188|NCT01424982|Drug|Ponatinib|Given PO
16196189|NCT01424982|Drug|Ponatinib Hydrochloride|Given PO
16196190|NCT01424982|Drug|Prednisone|Given PO
16196191|NCT01424982|Biological|Rituximab|Given IV
16196194|NCT01424956|Device|Automated Breast Ultrasound (ABUS)|Automated Breast Ultrasound (ABUS) as an adjunct to digital screening mammography.
16196195|NCT01424943|Behavioral|Stepping Stones Triple P|10-12 session manualized intervention delivered in client homes
16196196|NCT01424943|Other|BabyNet Services As usual|BabyNet services as usual based on IFSP
16196197|NCT01424930|Drug|Abiraterone|Participants will receive abiraterone acetate at a starting dose of 1,000 mg once daily for 7 days post 30-minutes of a standardized low-fat meal and high-fat meal from Cycle 1 Day 8 to Cycle 1 Day 14.
16196198|NCT01424930|Drug|Prednisone|Prednisone will be administered as 5 mg oral tablet twice daily during Cycle 1 Day 8 to Cycle 1 Day 14.
16196199|NCT01424904|Dietary Supplement|DGB-01 Supplementation|"Approximately one-half of the subjects will initially receive DGB-01. The other half of the subjects will receive casein. Investigators and subjects are blinded to the product the subject is receiving. Subjects will be asked to consume one pouch of their assigned study product twice daily for four weeks.
~Subsequently, all subjects will undergo a supplement-free washout period of at least four weeks duration. Following the washout period, the subjects who originally received DGB-01 will receive casein and the subjects who originally received casein will receive DGB-01. Subjects will be asked to consume one pouch of their assigned study product twice daily for four weeks."
16196200|NCT01424891|Drug|Simvastatin 80 mg|treatment with 80 mg of simvastatin over a period of 8 weeks
16196201|NCT01424891|Drug|Sim10/Eze10|treatment with combination of simvastatin 10 mg and ezetimibe 10 mg
16196202|NCT01424891|Drug|Placebo|treatment with placebo over 8 weeks
16196203|NCT01424865|Genetic|fluorescence in situ hybridization|
16196204|NCT01424865|Other|immunohistochemistry staining method|
16196205|NCT01424865|Other|immunologic technique|
16196206|NCT01424865|Other|laboratory biomarker analysis|
16196207|NCT01424852|Dietary Supplement|Probiotics in infant milk formula|Probiotic infgant milk formula administered during the forst year of life
16196208|NCT01424839|Radiation|craniospinal irradiation|"Metastatic or incompletely staged pure germinoma 24 Gy (15 fractions) to craniospinal axis with a 16 Gy (10 fraction) boost to tumour bed and any intracra-nial metastases and spinal deposits (total tumour dose 40 Gy)
~Metastatic germinoma plus teratoma (incompletely resected) 24 Gy (15 fractions) to craniospinal axis ; 30.4 Gy (19 fraction) boost to tumour bed and 16 Gy (10 frac-tion) boost to metastases (total tumour dose 54.4 Gy)
~Patients with metastastic non-germinomatous disease at diagnosis After Chemotherapy: 30 Gy (20 fractions) to cranio-spinal axis with 24 Gy (15 fraction) boosts to tumour site and any intracranial metastases (total tumour dose 54 Gy) and 20.8 Gy (13 fraction) boosts to spinal deposits (total dose 50.8 Gy)"
16196209|NCT01424839|Drug|Carboplatin, Etoposide, Ifosfamide|• Non-metastatic fully staged germinoma (± teratoma) Two courses (1 and 3) of Etoposide and Carboplatin, alternating with two courses (2 and 4) of Etoposide and Ifosfamide
16196210|NCT01424839|Radiation|ventricular irradiation|"Non-metastatic pure germinoma in PR/SD After Chemotherapy: 24 Gy (15 fractions) to whole ventricles with a 16 Gy (10 fraction) boost to tumour bed (total tumour dose 40 Gy)
~Non-metastatic germinoma in CR After Chemotherapy: 24 Gy (15 fractions) to whole ventricles
~Non-metastatic germinoma plus teratoma (incompletely resected) After Chemotherapy: 24 Gy (15 fractions) to whole ventricles; 30.4 Gy (19 fraction) boost to tumour bed (total tumour dose 54.4 Gy)"
16196211|NCT01424839|Drug|Cisplatin, etoposide, Ifosfamide (standard)|Four courses of Etoposide, Cisplatin and Ifosfamide (standard treatment )
16196212|NCT01424839|Drug|Cisplatin, Etoposide, Ifosfamide (high dose)|Two courses of standard Etoposide, Cisplatin and Ifosfamide, followed by two dose intensified courses of Etoposide, Cisplatin and Ifosfamide with stem cell support
16196213|NCT01424839|Radiation|focal irradiation|• Patients with localised non-germinomatous disease at diagnosis After Chemotherapy: 54 Gy focal radiotherapy in 30 fractions
16196214|NCT01424826|Drug|Raltegravir|400 mg bd for minimum of 28 days and maximum 35 days
16196215|NCT01424826|Drug|Rifampicin|< 50 kg 600 mg 3 times/week for a minimum of 27 days and maximum of 34 days > 50 kg 900 mg 3 times/week for a minimum of 27 days and maximum of 34 days
16196216|NCT01424826|Drug|Raltegravir|800 mg bd for 4 days
16196217|NCT01424813|Drug|Placebo MDPI|Placebo MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.
16196218|NCT01424813|Drug|Albuterol MDPI|Albuterol MDPI administered as 2 inhalations 4 times a day (QID) (at approximately 7:00 AM, 12 noon, 5:00 PM, and bedtime) for 12 weeks.
16196219|NCT01424800|Device|A disposable NIRS (near-infrared spectroscopy) sensor will be applied on the patient's forehead for continuous registration of the cerebral oxygen saturation.|When the patient is on CPB, pressure and/or flow will be changed while continuously measuring ScO2. Temperature, CO2 , arterial oxygen content, hematocrit and anesthesia will be kept constant during the measurements. First, baseline MAP (mean arterial pressure), baseline ScO2 and baseline central venous oxygen saturation (SvO2) are determined. With the interventions, we will induce a change of 20% in MAP and/or flow. This is within the normal range during operations. Changes in blood pressure will be obtained by the use of vasoactive agents (sodiumnitroprusside for blood pressure decrease and phenylephrine for blood pressure increase). Flow is regulated by manual control of the pump flow. Values of the different variables will be obtained after a 5 min stabilisation period. Flow/pressure interventions will be randomized.
16196220|NCT01424774|Drug|CardioGen-82|CardioGen-82 is not administered to patients in this study, however to be able to qualify for enrollment, the patients must have received CardioGen previously
16196221|NCT01424761|Dietary Supplement|Coenzyme Q10|Coenzyme Q10 300 mg/d (150 mg/bid)
16196222|NCT01424761|Other|Placebo|Placebo :starch
16196223|NCT01424748|Dietary Supplement|Tahitian Noni Juice|noni fruit juice
16196224|NCT01424748|Dietary Supplement|Placebo|Placebo juice
16196225|NCT01424735|Drug|Mycobacterium w.(Mw)-freeze dried extract 0.5ml|0.5 ml of Mw in 500ml 0.9% normal saline administered over two hours as an infusion. 2ml(4mg/ml) of dexamethasone administered two hours prior to Mw administration
16196226|NCT01424722|Device|Fortify® ST, Fortify Assura® ST, Ellipse® ST family of devices|Algorithm for detecting ST changes that may be indicative of an acute coronary syndrome.
16196352|NCT01423773|Device|Lotrafilcon A test contact lens|Silicone hydrogel single vision, soft contact lens with alternate parameters
16196353|NCT01423773|Device|Lotrafilcon A control contact lens|Silicone hydrogel single vision, soft contact lens
16196227|NCT01424709|Drug|Gemcitabine, Docetaxel, CPT-11,Cisplatin|Based on expression levels of RRM1 and BRCA1 mRNA，one of the four regimens will be given to each patient: Gemcitabine/cisplatin, Docetaxel/gemcitabine, CPT-11/Cisplatin, docetaxel monotherapy. The chemotherapy will be repeated every 3 week. Dose reduction or interruption for toxicity could take place at any time.
16196228|NCT01424709|Drug|gemcitabine/cisplatin|gemcitabine/cisplatin up to 6 cycles or disease progression or intolerable toxicity.
16196229|NCT01424670|Drug|Delamanid + OBR|The assigned doses of delamanid were administered with an OBR. The selection and administration of the OBR were based on WHO's guidelines for the programmatic management of drug-resistant TB, in conjunction with national TB program guidelines in each country.
16196230|NCT01424670|Drug|Placebo + OBR|Matching placebo was administered with an OBR. The selection and administration of the OBR were based on WHO's guidelines for the programmatic management of drug-resistant TB, in conjunction with national TB program guidelines in each country.
16196231|NCT01424657|Procedure|ERCP|Endoscopic retrograde cholangiopancreatography
16196232|NCT01424657|Procedure|MRCP|magnetic resonance cholangiopancreatography
16196233|NCT01424644|Biological|Placebo + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus Vaccine|"All three vaccines were administered concomitantly. Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine is GARDASIL®.
~Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine(Tdap) is Boostrix®."
16196234|NCT01424644|Biological|MenACWY-CRM Conjugate Vaccine + Combined Tetanus, Reduced Diphtheria Toxoid, Acellular Pertussis Vaccine + Quadrivalent Human Papillomavirus Vaccine|"All three vaccines were administered concomitantly. MenACWY-CRM contains diphtheria-like toxoid as carrier for the capsular polysaccharides. Quadrivalent Human Papillomavirus [Types 6, 11, 16, 18] Recombinant Vaccine is GARDASIL®.
~Reduced Diphtheria Toxoid,Acellular Pertussis Vaccine(Tdap) is Boostrix®."
16196235|NCT01424631|Procedure|single incision laparoscopic appendectomy|
16196236|NCT01424631|Procedure|conventional laparoscopic appendectomy|
16196237|NCT01424618|Drug|Leuprolide|leuprolide 10 units daily, decreased to 5 units daily once suppression achieved for a total of approximately 4 weeks. Once suppression achieved, estradiol and progesterone administered to mature uterine lining.
16196238|NCT01424618|Drug|Ganirelix|Ganirelix 250 mcg daily will be used to suppress pituitary-ovarian function and is administered concurrently with estradiol and progesterone for approximately two weeks.
16196239|NCT01424605|Procedure|DLT intubation|Using a video-assisted laryngoscope to facilitate endotracheal tube intubation
16196240|NCT01424592|Device|Testing with a portable sleep apnea monitor .|Portable sleep apnea testing will performed on referred patients.
16196241|NCT01424579|Other|Actual Diacutaneous Fibrolysis|Diacutaneous Fibrolysis is a non-invasive physiotherapeutic technique applied by means of a set of metallic hooks ending in a spatula with bevelled edges that allow a deeper and more precise application, which could not be achieved manually. Appropriate hook is applied following the intermuscular septum between the muscles with an anatomical or functional relationship with the painful structure, in a centripetal direction towards the pain location, in order to release adherences between musculoskeletal structures.
16196242|NCT01424579|Other|Placebo Diactuaneous Fibrolysis|Placebo Diacutaneous Fibrolysis was applied at a superficial level and, instead of fibrolysis, a pinch of skin was held with the thumb of the palpatory hand and the tip of the spatula, without any action taking place on the deep tissular levels.
16196243|NCT01424579|Other|Protocolized physiotherapeutic Treatment|Tree weeks of daily therapeutic exercises, analgesic electrotherapy and cryotherapy.
16196244|NCT01424566|Drug|Nabiximols|
16196245|NCT01424566|Drug|Placebo (GA-0034)|
16196246|NCT01424553|Other|Prevention and follow-up of the patients pulmonary parameters|Respiratory symptoms and lung function will be evaluated in very low birth weight and term infants, born in 1997 and included in the French EPIPAGE cohort.
16196247|NCT01424540|Drug|GSK2336805 150mg|Single Dose
16196248|NCT01424540|Other|Placebo|Single Dose
16196249|NCT01424514|Drug|SB-705498|12mg intra nasal
16196250|NCT01424514|Drug|Placebo|Placebo intra nasal
16196251|NCT01424501|Biological|GSK Biologicals' investigational TB vaccine GSK 692342|Intramuscular injection, 2 doses
16196252|NCT01424501|Biological|Placebo|Intramuscular injection, 2 doses
16196253|NCT01424488|Drug|sugammadex|Anesthetised patients will receive a single intubation dose of succinylcholine (1.0 mg/kg) and maintenance bolus dose of pipecuronium (0.08 mg/kg) to maintain the level of neuromuscular blockade at reappearance of T2 Sugammadex in the dose of 4 mg/kg is to be administered as an intravenous bolus dose at the level of neuromuscular blockade of reappearance of T2 (moderate blockade) by means of TOF-Watch SX after the last dose of pipecuronium according to randomization
16196254|NCT01424488|Drug|placebo|Anesthetised patients will receive a single intubation dose of succinylcholine (1.0 mg/kg) and maintenance bolus dose of pipecuronium (0.08 mg/kg) to maintain the level of neuromuscular blockade at reappearance of T2. 3,0 ml of saline (placebo) is to be administered as an intravenous bolus dose at the level of neuromuscular blockade of reappearance of T2 (moderate blockade) by means of TOF-Watch SX after the last dose of pipecuronium according to randomization
16196255|NCT01424475|Genetic|Healthy|Healthy Volunteers
16196256|NCT01424475|Genetic|PKD Patients|PKS Patients
16196257|NCT01424462|Drug|A|Single dose treatment IR formulation
16196258|NCT01424462|Drug|B|Low Extended release single dose
16196259|NCT01424462|Drug|C|Medium extended release formulation
16196260|NCT01424462|Drug|D|High extended release rate single dose
16196261|NCT01424449|Radiation|[11C]PHNO|examine the effects of [11C]PHNO mass carry-over and displaceable binding
16196262|NCT01424449|Drug|Aripiprazole|A 4th scan will follow a 15mg dose of aripiprazole (a D2/D3 compound which allows the highest clinically acceptable blockade of central D2/D3 receptors)
16196263|NCT01424436|Biological|GSK933776|1mg/kg dose group
16196264|NCT01424436|Biological|GSK933776|3mg/kg dose group
16196265|NCT01424436|Biological|GSK933776|6mg/kg dose group
16196266|NCT01424423|Drug|Placebo|Placebo
16196267|NCT01424423|Drug|GSK1223249|I.V. Infusion
16196268|NCT01424397|Drug|SB-705498|12mg intranasal
16196269|NCT01424397|Drug|FP|200ug intranasal
16196270|NCT01424397|Drug|placebo|placebo intranasal
16196274|NCT01424358|Other|Web-based Educational Intervention|The intervention group will be invited to participate in the web-based educational program. PCPs in the intervention group will be asked to view the educational module which will be followed by an assessment. This group will be tested on the following knowledge outcomes: Index of knowledge of risk factor for oral cancer and Index of knowledge of diagnostic procedures for oral cancer.
16196275|NCT01424345|Drug|adjustment of immunosuppressant dosages|adjustment of immunosuppressant dosages according to the results of ImmuKnow results and routine post-transplant lab results
16196276|NCT01424345|Drug|adjustment of the dosages of immunosuppressants|adjustment of the dosages of immunosuppressants will be done according to the results of conventional post-transplant follow-up lab
16196277|NCT01424332|Drug|Darexaban|oral
16196278|NCT01424332|Drug|Acetyl Salicylic Acid (ASA)|oral
16196279|NCT01424319|Drug|Atrasentan low dose group|Subjects will take two tablets daily of one of those which are atrasentan low dose, atrasentan high dose or atrasentan placebo for 12 weeks during the treatment period.
16196280|NCT01424319|Drug|Atrasentan high dose group|Subjects will take two tablets daily of one of those which are atrasentan low dose, atrasentan high dose or atrasentan placebo for 12 weeks during the treatment period.
16196281|NCT01424319|Drug|Atrasentan placebo group|Subjects will take two tablets daily of one of those which are atrasentan low dose, atrasentan high dose or atrasentan placebo for 12 weeks during the treatment period.
16196282|NCT01424306|Other|Fructose-sweetened beverages|In addition to consuming a standardized diet, subjects will be asked to consume 4 servings per day of a fructose-sweetened beverage for 8 days. The amount of fructose consumed will be 25% of the subject's estimated daily calorie requirement.
16196283|NCT01424306|Other|Glucose-sweetened beverages|In addition to consuming a standardized diet, subjects will be asked to consume 4 servings per day of a glucose-sweetened beverage for 8 days. The amount of glucose consumed will be 25% of the subject's estimated daily calorie requirement.
16196284|NCT01424306|Other|High-fructose corn syrup-sweetened beverages|In addition to consuming a standardized diet, subjects will be asked to consume 4 servings per day of a high-fructose corn syrup-sweetened beverage for 8 days. The amount of high-fructose corn syrup consumed will be 25% of the subject's estimated daily calorie requirement.
16196285|NCT01424293|Device|Indocyanine Green|1ml of intravenous ICG and imaging transanally using the Spyscope system
16196286|NCT01424293|Device|The SPY® Intraoperative Imaging System|
16196287|NCT01424280|Drug|1440115|Single dose of either 750 mg or 500 mg administered as 250 mg tablets.
16196288|NCT01424280|Drug|Placebo|Single dose of matching placebo tablets
16196289|NCT01424267|Device|Zenith® Low Profile AAA Endovascular Graft|Treatment of an abdominal aortic or aorto-iliac aneurysm with the CE-marked Zenith(R) Low Profile AAA Endovascular Graft.
16196290|NCT01424254|Device|Capsule GIVEN IMAGING|Injection of Capsule Endoscopy
16196291|NCT01424254|Procedure|Push-Enteroscopy|currently recommended standard
16196292|NCT01424241|Drug|Sandostatin LAR|This will be a open label dose escalation study of Sandostatin LAR 10 Mg, 20Mg, 30 Mg up to 40 mg if necessary.
16196293|NCT01424228|Drug|placebo|Placebo matching tablet 2 mg once daily before breakfast for 24 weeks
16196294|NCT01424228|Drug|prucalopride|"Prucalopride 2 mg daily before breakfast
~1 mg for subjects >65 years; in case of insufficient response 2 mg at week 2 or week 4"
16196295|NCT01424215|Drug|Indocyanine Green (ICG)|Injection of ICG intravenously then intraoperative imaging of the biliary anatomy during laparoscopic cholecystectomy using a near infrared (NIRF) imaging camera(Spy scope, Novadaq Canada)
16196296|NCT01424202|Device|Mechanical Insufflation Exsufflation|"After passing the SBT and randomized to group B, before extubation, all patients were submitted to a treatment of MI-E (3 sessions) through the endotracheal tube with pressures set at 40 cm H2O for insufflation and -40 cm H2O for exsufflation pressure. An insufflation/exsufflation time ratio of 3secs/2 secs and a pause of 3 sec between each cycle was used. Eight cycles were applied in every session with an abdominal thrust timed to the exsufflation cycle.
~On top of the standard medical therapy, during the first 48 hours post extubation, each patient received 3 daily treatments by means of a light-weight, elastic oronasal mask. Treatments (3 sessions each) were divided between morning, afternoon and night, making a total of 9 daily sessions.
~The daily treatment frequency and its outcomes were recorded in a diary by the nursing staff. All MI-E treatments were administered by a trained respiratory therapist, ICU physician or nurse."
16196297|NCT01424189|Device|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL|Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
16196298|NCT01424189|Device|AcrySof® ReSTOR® Multifocal IOL Model SA60D3|Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient
16196299|NCT01424176|Drug|Dexpramipexole (dose 1)|
16196300|NCT01424176|Drug|Dexpramipexole (dose 2)|
16196301|NCT01424163|Drug|Single dose reduced|Treatment 1 (Part A)
16196302|NCT01424163|Drug|Single dose standard|Treatment 2 (Part A)
16196303|NCT01424163|Drug|Multiple Dose|Treatment 3 (Part A)
16196304|NCT01424163|Drug|Multiple Dose|Part B
16196305|NCT01424150|Other|Liberal fluid therapy|Liberal protocol group is designed to provide approximately 6.0L per day.
16196306|NCT01424150|Other|Restrictive fluid therapy|Restrictive protocol group is designed to provide less than 2.0 L water and 120 mmol sodium per day.
16196307|NCT01424137|Device|Easyhaler type A|Easyhaler type A inhaler, 3 consecutive inhalations
16196308|NCT01424137|Device|Easyhaler type B|Easyhaler type B inhaler, 3 consecutive inhalations
16196309|NCT01424137|Device|Diskus inhaler|Diskus inhaler, 3 consecutive inhalations
16196310|NCT01424124|Drug|YHD001 dose level 1|Tablet, three times daily / 8 weeks
16196311|NCT01424124|Drug|YHD001 dose level 2|Tablet, three times daily / 8 weeks
16196312|NCT01424124|Drug|Singulair|Tablet, one times daily / 8 weeks
16196313|NCT01424124|Drug|Placebo|Tablet, one times daily / 7 days
16196314|NCT01424111|Drug|Escitalopram|An open-label, 10-20 mg/day, flexible-dose of escitalopram will be administered to all subjects included in this study in the form of tablets. The treatment period is 8 weeks long.
16196315|NCT01424111|Other|Healthy Control|No Treatment
16196625|NCT01421784|Other|cine MRI|Rapid Cine-MRI for Monitoring Moving and Deforming Tumors
16196316|NCT01424098|Behavioral|Balance training program|Training will consist of 30 minute sessions 3 times/week for 6 weeks in keeping with best practice guidelines for older adults. Sessions will be supervised by physical therapists, using a circuit training approach with different stations designed to target specific areas of impairment. Participants will work through stations in a group setting; however, will receive individualized exercise prescription regarding level of difficulty and exercise progression.
16196317|NCT01424072|Other|auriculotherapy by needles|The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.
16196318|NCT01424072|Other|auriculotherapy by seeds|We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day.
16196319|NCT01424059|Other|WEDQ-B (questionnaire)|Questionnaires are answered after delivery; within 48 hours and after five weeks
16196320|NCT01424046|Drug|basal insulin glargine|Individuals assigned to this arm will initially receive a basal insulin injection daily and gradually be introduced to meal time coverage of blood sugar with additional short acting insulin. Education will like wise proceed in a stepwise manner.
16196321|NCT01424046|Drug|standard therapy|Participants will continue with current mixed insulin treatment using NPH , or lente, and regular insulin .
16196322|NCT01424033|Drug|N-Acetylcysteine|600mg by mouth, three times daily for 12 months
16196323|NCT01424020|Other|Questionnaire|Self completed questionnaire, Supervised by the physician Ankle brachial index (ABI) calculation Maximal walking distance (MWD) on treadmill or over the 6 minutes walking test (when available)
16196324|NCT01424007|Behavioral|Weight loss|Participants would receive print materials on diet and exercise and attend group sessions that would meet weekly for the first 4 months, then every two weeks for the next 2 months, and then monthly for the next 6 months over the course of one year.
16196325|NCT01423994|Procedure|pacemaker|"A single or dual chamber pacemaker will be implanted according to the manufacturer's instructions for use with standard techniques.
~Either a single or dual chamber pacemaker will be permitted according to local practice unless the patient is in chronic or persistent atrial fibrillation, in which case a single chamber pacemaker will be used. The pacemaker configuration will be at the discretion of the investigator.
~Single chamber ventricular pacemakers will be programmed to activity responsiveness off in VVI mode, rates 50-120 bpm.
~Dual chamber pacemaker programming will be to DDD mode (50-120) with mode switch on."
16196326|NCT01423994|Procedure|implantable loop recorder|The implantable loop recorder will be programmed for automatic detection using settings of Low Heart Rate <50 bpm, High Heart Rate >165 bpm, and Pause > 3 seconds.
16196327|NCT01423968|Biological|Lipopolysaccharide infusion|Lipopolysaccharide 4 nanogram/kg body weight
16196328|NCT01423968|Other|saline|
16196329|NCT01423955|Drug|Erythropoietin zeta|The active drug will be given only once after the anesthesia induction and before the start of surgery. The active drug will be diluted to 2000U/kg and given as a single dose of 400U/kg. The dose will be prepared prior to surgery by a independent nurse.
16196330|NCT01423955|Drug|Placebo|Placebo arm will receive NaCl 9mg/ml with a dose of 0.2 ml/kg. The placebo dose will be prepared prior to the surgery by a independent nurse. The calculated volume will match the volume of the active durg.
16196331|NCT01423929|Drug|Oxygen|Fitting of Oxymask TM and treatment with 10 L O2/min
16196332|NCT01423929|Device|Room air|Fitting of Oxymask TM
16196333|NCT01423916|Drug|OPC-34712 (4mg)|Arms assigned to this intervention receive 4mg.
16196334|NCT01423916|Drug|Moxifloxacin|Arms assigned to this intervention will receive 400mg.
16196335|NCT01423916|Drug|OPC-34712 (12mg)|Arms assigned to this intervention receive 12mg.
16196336|NCT01423916|Drug|Placebo|OPC-34712 placebo
16196337|NCT01423903|Drug|OPB-51602|A cycle will consist of 28 days of OPB-51602 be taken by study subjects daily by mouth for every day of each 28 day cycle.
16196338|NCT01423890|Genetic|ONCOTYPEDX Test|Gene signature test containing 21 genes (16 cancer-related genes, e.g., invasion, proliferation, ER, Her 2 and five reference genes) and generates an individualized recurrence score.
16196339|NCT01423864|Drug|conventional ECMO with intravenous steroid|refractory acute respiratory distress syndrome and multi-organ dysfunction syndrome treated with intravenous steroid, Solu-Cortef 50mg q6h taper down when hemodynamic stable
16196340|NCT01423864|Drug|solumedrol|Initially, intrapleural steroid administration was performed using 40 mg solumedrol q6h (for both the pleural cavities). If chest radiography showed an improvement in consolidation, i.e., 0.8 > FiO2 ≥ 0.5 and 5 ≤ PEEP ≤ 10, the dosage of solumedrol was reduced to 40 mg q12h. When FiO2 was below 0.5 and the PEEP was below 10, the dosage of solumedrol was lowered to 40 mg qd for 3 days and then its administration was discontinued.
16196341|NCT01423851|Drug|NS-018|Treatment will be administered continuously as oral daily therapy in cycles of 4 weeks in duration (28 day treatment cycles).
16196342|NCT01423838|Drug|Solifenacin|5 mg, oral, once in a day
16196343|NCT01423838|Drug|Oxybutynin|5 mg, oral, three times in a day
16196344|NCT01423825|Biological|Sub C gp140 Vaccine|100 mcg of Sub C gp140 vaccine admixed with MF59C.1 adjuvant administered as one 0.5 mL injection intramuscularly (IM) in either deltoid
16196345|NCT01423825|Biological|MF59C.1 Adjuvant|MF59C.1 adjuvant admixed with 100 mcg of Sub C gp140 vaccine administered as one 0.5 mL injection intramuscularly (IM) in either deltoid. MF59C.1 adjuvant contains no biologicals.
16196346|NCT01423825|Other|Sodium chloride|Sodium chloride as 0.5 mL IM injection in either deltoid to act as placebo
16196347|NCT01423812|Drug|Twice-daily Darunavir and ritonavir|Subjects remain on regimens containing Darunavir 600mg plus Ritonavir 100mg twice-daily
16196348|NCT01423812|Drug|Once-daily Darunavir and ritonavir|Subjects switched from Darunavir 600mg plus Ritonavir 100mg twice-daily at baseline to Darunavir 800mg plus Ritonavir 100mg once-daily for 48 weeks
16196349|NCT01423799|Dietary Supplement|Nutritional supplements containing arginine, n-3 and nucleotides|Nutritional intervention with immuno-nutrients
16196350|NCT01423799|Dietary Supplement|Isocaloric control|Isocaloric and isonitrogenous control without immuno nutrients
16196351|NCT01423786|Dietary Supplement|Early Oral Nutrition|Once enrolled in the study, patients will be allowed a oral diet that is low in fat.
16196950|NCT01419210|Other|Educational Presentations|Attend a two-hour presentation each week for four weeks
16196354|NCT01423773|Device|Ultra-High Resolution Optical Coherence Tomographer (OCT)|Investigational, nonsignificant risk device for measuring post lens clearance and ocular tissue compression during contact lens wear
16196355|NCT01423760|Biological|Tecemotide|Subjects who received tecemotide (L-BLP25) for the treatment of non-small cell lung cancer (NSCLC) or multiple myeloma in a feeder trial will continue to be treated with tecemotide (L-BLP25) and have safety assessments performed until the discontinuation criteria in the respective feeder trial protocol are met.
16196356|NCT01423760|Other|No intervention|Subjects who had not received tecemotide in the feeder study, or who had discontinued treatment with tecemotide (L-BLP25), will only be observed for progressive disease (PD) (if applicable) and survival in 6-month intervals and will not be provided treatment with tecemotide (L-BLP25).
16196357|NCT01423747|Drug|VP16|patients with MSD receive as conditioning VP16 60mg/kg/d on day -3
16196358|NCT01423747|Radiation|TBI|patients with a MSD receive TBI (12Gy in 6 fractions) as conditioning
16196359|NCT01423747|Drug|VP16, ATG|patients with a HLA matched unrelated Donor (9/10 oder 10/10) receive VP16 60mg/kg/d on day -3 and ATG fresenius 20mg/kg/d on day -3,-2,-1
16196360|NCT01423747|Radiation|TBI|patients with a HLA matched unrelated Donor (9/10 oder 10/10) receive TBI (12Gy in 6 fractions)
16196361|NCT01423747|Drug|Fludarabine, OKT3, Treosulfan, Thiotepa|patients with a MMD (haploidentical or cord blood) receive Fludarabine 30mg/m²/d on day -9 to -5, ATG 20mg/kd/d on day -3 to day -1, Treosulfan 14g/m²/d on day -7 to -5 and Thiotepa 2x5mg/kg/d on day -4
16196362|NCT01423747|Drug|VP16, ATG|patients with MMD-transplantation (8/10)receive VP16 60mg/kg/d on day -4, ATG from day -3 to day-1 20mg/kg/d
16196363|NCT01423747|Radiation|TBI|patients with a MMD-transplantation (8/10) receive 12 Gy in 6 fractions
16196364|NCT01423734|Other|magnetic resonance imaging (MRI)|"Each patient will undergo clinical and research MRI examinations. Before any MRI examination, the patient will answer a standard radiology MR department questionnaire form, with specific questions addressing contra-indications to MRI. The questionnaire form will be reviewed by radiology personnel as per standard practice.
~During the research MRI, the patient will be monitored visually and communication will be maintained between the patient and the MR technologists via a speaker system. At the termination of the study, the patient will be evaluated by the MR department radiology personnel as done routinely. Two breath hold DWI sequences will be performed for each patient. Since this is a reproducibility study, identical scan parameters will be used for the clinical and research MRI. The multiple b value DWI will be performed using the enhanced DW sequence that have been recently made available on our 3.0 Tesla MR 750 scanners at the Breast and Imaging Center."
16196365|NCT01423721|Drug|Bromihexine hydrochloride syrup|syrup
16196366|NCT01423721|Drug|Bromihexine hydrochloride granules|granules
16196367|NCT01423708|Drug|Everolimus|Administration of Everolimus within 24 hours from the time of randomization (7 days from the time of transplantation) in association with Tacrolimus and steroids. The first dose level of the trough will be performed at day 7 after initiation of therapy. After the reaching an Everolimus trough level of >5ng/ml (final target 6-12 ng/ml), there will be a gradual weaning of tacrolimus (bringing Tacrolimus blood levels <5 ng/ml) with discontinuation of Tacrolimus within 30 days after transplantation when possible.
16196368|NCT01423695|Drug|paclitaxel plus trastuzumab|Weekly paclitaxel (90 mg/m² iv, 12 courses) plus weekly trastuzumab (4mg/kg body weight iv as loading dose, 2 mg/kg iv from week 2 onwards; continued until disease progression)
16196369|NCT01423682|Behavioral|Eccentric exercise|Patients and healthy subjects will perform an eccentric exercise during which a weight is lifted along the body and lowered with an extended arm at a slow speed. Weight is determined, based on pain in patients and based on force in healthy subjects.
16196370|NCT01423656|Drug|LEO 29102|
16196371|NCT01423656|Drug|Placebo|Placebo Comparator: LEO 29102 vehicle
16196372|NCT01423630|Dietary Supplement|Probiotics and fruit fibre|probiotics and fruit fibre
16196373|NCT01423617|Dietary Supplement|Zenoctil|3 tablets 2 times daily
16196374|NCT01423617|Other|Placebo|3 tablets 2 times daily
16196375|NCT01423604|Drug|Capecitabine|Capecitabine starting dose - 2000 mg/m^2 (1000 mg/m^2 twice a day (BID)) (NOTE: Frequency of administration may be adjusted during the study.)
16196376|NCT01423604|Drug|Ruxolitinib|Ruxolitinib starting dose - 15 mg BID (NOTE: Starting dose of randomized study drug may be 10 mg BID based on results from safety run-in study. Dose of ruxolitinib may be increased during randomized study.)
16196377|NCT01423604|Drug|Placebo|Placebo matching ruxolitinib
16196378|NCT01423591|Drug|infliximab|Infliximab 5 mg/kg. i.v. at week 0, 2, 6, 14 y 22.
16196379|NCT01423591|Drug|inactive powder|Inactive powder. i.v. at week 0, 2, 6, 14 y 22.
16196380|NCT01423578|Behavioral|Hatha Yoga (HY)|3 Sessions of yoga instruction
16196381|NCT01423578|Behavioral|Cardiovascular Exercise (CE)|3 sessions of cardiovascular exercise
16196382|NCT01423578|Behavioral|Smoking Cessation Counseling|4 smoking cessation counseling visits.
16196383|NCT01423565|Device|Deep Brain Stimulation (Medtronic, Activa PC)|"Following subthalamic nucleus deep brain stimulation patients will be randomized to receive either constant current or constant voltage stimulation and subsequently crossed over to receive the other type of stimulation"
16196384|NCT01423539|Drug|bendamustine|Intravenous repeating dose\n
16196385|NCT01423539|Drug|navitoclax|Oral repeating dose\n
16196386|NCT01423539|Drug|rituximab|Intravenous repeating dose\n
16196387|NCT01423526|Drug|DWP10292|Drug: DWP10292 tablets, oral administration, single administration
16196388|NCT01423526|Drug|Placebo|Placebo tablets, oral administration, single administrations
16196389|NCT01423513|Other|Fibular Taping|Tape with be applied with tension.
16196390|NCT01423513|Other|Sham Taping|Tape will be applied without tension
16196391|NCT01423500|Drug|VP16|patients with MSD receive as conditioning VP16 60mg/kg/d on day -3
16196392|NCT01423500|Radiation|TBI|patients with a MSD receive TBI (12Gy in 6 fractions) as conditioning
16196393|NCT01423500|Drug|VP16, ATG|patients with a HLA matched unrelated Donor (9/10 oder 10/10) receive VP16 60mg/kg/d on day -3 and ATG fresenius 20mg/kg/d on day -3,-2,-1
16196394|NCT01423500|Radiation|TBI|patients with a HLA matched unrelated Donor (9/10 oder 10/10) receive TBI (12Gy in 6 fractions)
16196526|NCT01422551|Behavioral|Cognitive Behavioral Stress Management|10 weekly 2-hour sessions of group-based cognitive behavioral stress management
16196395|NCT01423500|Drug|Fludarabine, OKT3, Treosulfan, Thiotepa|patients with a MMD (haploidentical or cord blood) receive Fludarabine 30mg/m²/d on day -9 to -5, ATG fresenius 20mg/kg/d on day -3,-2,-1, Treosulfan 14g/m²/d on day -7 to -5 and Thiotepa 2x5mg/kg/d on day -4
16196396|NCT01423500|Drug|VP16, ATG|patients with MMD-transplantation (8/10)receive VP16 60mg/kg/d on day -4, ATG from day -3 to day-1 20mg/kg/d
16196397|NCT01423500|Radiation|TBI|patients with a MMD-transplantation (8/10) receive 12 Gy in 6 fractions
16196398|NCT01423487|Drug|Metformin|0.5g bid 26 weeks
16196399|NCT01423487|Other|Starch tablets|0.5g bid 26 weeks
16196400|NCT01423474|Radiation|Image-guided radiotherapy|40 Gy / 5 fractions / 11 days
16196401|NCT01423474|Radiation|Image-guided radiotherapy|40 Gy / 5 fractions / 29 days
16196402|NCT01423448|Other|bulletin board|An asynchronous online bulletin board for people with experience of depression
16196403|NCT01423435|Drug|TRK-100STP|oral
16196404|NCT01423409|Device|pictorial VAS|Pictorial VAS includes elements which promote understanding of Deaf people: colours and 6 detailed expressive faces.
16196405|NCT01423409|Device|usual VAS|usual visual analog scale (VAS) of pain (line from 0: no pain to 10:worst pain)
16196406|NCT01423396|Other|optimal care of VRF|VRF of AD patients will be treated optimally in strict compliance with the French HAS guidelines concerning targets for blood pressure, glycaemia and blood lipid levels, in accordance with standardized therapeutic regimens.
16196407|NCT01423396|Other|standard care|AD patients will be followed with the city doctor and the letter t will be send for remember French HAS guidelines
16196408|NCT01423370|Drug|YHD1023|5g oral once daily
16196409|NCT01423370|Drug|YHD1023|5g oral twice a day
16196410|NCT01423370|Drug|YHD1023|10g oral once daily
16196411|NCT01423370|Drug|Cialis|5mg oral once daily
16196412|NCT01423370|Drug|Placebo|Oral
16196413|NCT01423357|Other|Condom distribution and peer education|Condom distribution and condom demonstrations by youth peer educators at least twice a week
16196414|NCT01423318|Drug|lebrikizumab|Dose-level cohorts receiving single subcutaneous dose
16196415|NCT01423318|Drug|placebo|single dose subcutaneously
16196416|NCT01423305|Drug|Budesonide/formoterol capsule.|Oral administration with concomitant charcoal.
16196417|NCT01423305|Drug|Budesonide/formoterol capsule for oral adm.|Oral administration without concomitant charcoal.
16196418|NCT01423292|Procedure|Ultrasound Guided Transversus Abdominis Plane (TAP) Block|Ultrasound Guided Transversus Abdominis Plane (TAP) Block
16196419|NCT01423292|Drug|bupivacaine|0.25 bupivacaine 30ml (15ml on each side)
16196420|NCT01423292|Drug|Placebo|placebo
16196421|NCT01423266|Procedure|12-week supervised weight loss intervention|Patients in the 2 study arms will participate in an intensive 12-week supervised weight loss intervention and will be seen by the same dietician at regular intervals: baseline, 2 weeks, 4 weeks, 8 weeks, and 12 weeks. Participants will receive personalized nutrition counseling and support during each of these visits. Participants will be randomized to either the HP or SP diet and assigned to receive one of two standard structured energy-restricted meal plans (1200, 1500 Kcal/day) based on the computed calorie deficit
16196422|NCT01423253|Drug|Lurasidone|Lurasidone 20, 40, or 60 mg/day, orally, once daily (QD) in the evening, with a meal or within 30 minutes after eating, flexibly dosed
16196423|NCT01423240|Drug|Lurasidone 20 mg|Lurasidone 20 mg once daily orally in the evening
16196424|NCT01423240|Drug|Lurasidone 60 mg|Lurasidone 60 mg once daily orally in the evening
16196425|NCT01423240|Drug|Placebo|Placebo once daily orally in the evening
16196426|NCT01423227|Behavioral|Home-based pulmonary rehabilitation|One home visit plus weekly telephone calls for 8 weeks
16196427|NCT01423227|Behavioral|Hospital-based pulmonary rehabilitation|Standard twice-weekly 8-week outpatient pulmonary rehabilitation program
16196428|NCT01423214|Procedure|robot-assisted surgery|da Vinci surgical system® (Intuitive Surgical, Sunnyvale, CA, USA)
16196429|NCT01423214|Procedure|Laparoscopic surgery|Conventional laparoscopic procedures
16196430|NCT01423188|Drug|RVX000222|capsule, 200 mg, administer with food, 100 mg twice daily 10-12 hrs apart, 24 weeks
16196431|NCT01423188|Drug|Placebo RVX000222|capsule, administer with food, twice daily 10-12 hrs apart, 24 weeks
16196432|NCT01423175|Drug|Clofarabine, ara-C|
16196433|NCT01423175|Drug|FLAMSA|
16196434|NCT01423162|Other|Dietary Intervention (with Vit C then without Vit C)|Fortified oat drink with vitamin C followed by fortified oat drink without vitamin C
16196435|NCT01423162|Other|Dietary Intervention (without Vit C followed by with Vit C)|Fortified oat drink without vitamin C followed by fortified oat drink with vitamin C
16196436|NCT01423149|Drug|Combretastatin A-4 Phosphate|Combretastatin A-4 Phosphate is administered on Day 0 and Day 7 (+/- 2 days). If the treating ophthalmologist notes any leakage from CNV in the study eye on a fluorescein angiography during the study or an increase in subretinal fluid on an optical coherence tomography measurement, retreatment with Combretastatin A-4 Phosphate is recommended with up to 3 additional treatments. The retreatment visit(s) could occur during a scheduled visit or at an additional visit 1 week after a regular study visit. A post-retreatment follow-up visit is necessary.
16196437|NCT01423136|Device|Remote ECG monitoring Spacelab SL 1050|If ischemia noted, Sx will be notified and currently accepted treatments of myocardial ischemia will be recommended.
16196438|NCT01423123|Drug|Paclitaxel|80 mg/m2 IV on days 1, 8, and 15 every 28 days until disease progression.
16196439|NCT01423123|Biological|trastuzumab|4 mg/kg IV loading dose, then 2 mg/kg IV weekly until disease progression.
16196440|NCT01423123|Drug|Neratinib|Dose level 1: 120 mg/day orally; Dose level 2: 160 mg/day orally; Dose level 3: 240 mg/day orally; Dose level 4: 200 mg/day orally.
16196441|NCT01423110|Biological|BYM338|
16196442|NCT01423110|Biological|Placebo|
16196443|NCT01423084|Biological|Serogroup B meningococcal vaccine|"All subjects will receive two rMenB+OMV NZ vaccinations one month apart and will be followed for a total of 2 months. Subjects will be randomized to 1 of 2 treatment arms to receive either two doses of rMenB+OMV NZ vaccine Lot 1 or two doses of rMenB+OMV NZ Lot 2.
~A total of 2 blood samples will be collected (at the first vaccination and 1 month after the 2nd vaccination). An additional blood draw will be collected in a subset of approximately 160 subjects (approximately 80 subjects in Group 1 and approximately 80 subjects in Group 2) at 2 weeks after the second vaccination"
16196444|NCT01423058|Drug|Momelotinib|"In the Part I dose-escalation phase of the study, subjects will be assigned to dose levels in successive cohorts starting with a dose in the first cohort of 200 mg BID (twice daily with doses taken approximately 12 hours apart. Doses will be escalated by 50 mg BID in successive cohorts of 3 subjects per dose level. Subjects will be evaluated weekly for the first cycle, every 2 weeks during cycle 2, then monthly for 4 cycles for a total of 6 cycles.
~In the dose confirmation phase of the study (Part 2), subjects will be evaluated every 2 weeks during the first treatment cycle, and then monthly for 5 cycles for a total of 6 cycles."
16196445|NCT01423032|Drug|bendamustine|100 mg/m² iv, day 1+2, q4w
16196446|NCT01423032|Drug|Fludarabine|25 mg/m² iv, days 1-5, q4w
16196447|NCT01423019|Dietary Supplement|Advantra Z|Two capsules are taken twice daily, 20-30 minutes before breakfast and evening meals. Two capsules contain a total of 50 mg p-synephrine.
16196448|NCT01423019|Dietary Supplement|Advantra Z + Naringin + Hesperiden|Two capsules are taken twice daily, 20-30 minutes before breakfast and evening meals. Two capsules contain a total of 50 mg p-synephrine, 600 mg naringin, and 100 mg hesperiden.
16196449|NCT01423019|Other|Sugar pill|Two capsules containing inert ingredients are taken twice daily, 20-30 minutes before breakfast and evening meals.
16196450|NCT01423006|Procedure|Radio-Frequency Ablation (RFA) ENCAGE™|RFA is a minimally invasive procedure. It is an image-guided technique that heats and destroys cancer cells. In RFA, imaging techniques such as ultrasound or magnetic resonance imaging (MRI) are used to help guide a needle electrode into a cancerous tumor. High-frequency electrical currents are then passed through the electrode, destroying the cancer cells.
16196451|NCT01422993|Other|12 Week Exercise Program|Participants will be asked to take part in a one hour exercise program twice a week for 12 weeks. They will also be asked to answer questionnaires and participate in an evaluation of their strength, balance, and physical function every 4 weeks immediately following the exercise program. This evaluation will take an additional hour every 4 weeks.
16196452|NCT01422980|Other|1- Test dairy product containing specific ingredients|
16196453|NCT01422980|Other|2- Control dairy product without specific ingredients|
16196454|NCT01422967|Behavioral|Balance and muscle strength|Balance test: bi and unipodal balance in the place force Muscle strength: bilateral test of knee in dynamometer isokinetic
16196455|NCT01422954|Drug|Chloroquine prophylaxis|Standard prophylactic regime: a loading dose of 300 mg on day 14 and day 17 and then 300 mg once a week, starting on day 21, for a total duration of 13 weeks. On day 0, day 3, day 7 and day 10, this group will receive a placebo.
16196456|NCT01422954|Drug|Mefloquine prophylaxis|Mefloquine prophylaxis, starting with a loading regime of split doses during the first three weeks: 125 mg on day 0, day 3, day 7, day 10, day 14 and day 17 and 250 mg once a week from day 21 onwards for a total duration of 13 weeks.
16196457|NCT01422954|Biological|Immunization|Group 1 and 2 will receive three immunizations with Plasmodium falciparum infected mosquito-bites. Group 3 will receive an equal number of uninfected mosquito-bites.
16196458|NCT01422954|Biological|Controlled Human Malaria Infection|Exposure to the bites of 5 Plasmodium falciparum infected mosquitoes.
16196459|NCT01422954|Drug|Malarone|When thick smear positive, of ar day 21 after challenge, all volunteers will be treated with malarone.
16196460|NCT01422941|Device|CAVU Attune Device|The CAVU Attune device is used with LAGB.
16196461|NCT01422928|Procedure|Medical Acupuncture|"Subjects will be asked to report symptom concerns. Subjects are requested to wear loose clothing as most acupoints lie at or distal to the elbow and knee.
~Sterile single use steel needles (ITO Adiquip 0.25 x 4.0 cm) will be inserted to a depth of 1 - 2 cm at acupoints thought to impact positively on the immune system. An ITO ES-160 Electrostimulator will be used to mimic the pecking technique of manual stimulation. Following needle insertion by the acupuncturist, a nurse or acupuncture student may assist by attaching electrodes to provide electrical stimulation. A 0.3 ms duration, 4 HZ, alternating current will be delivered with voltage set just below the pain threshold of the patient. After 20 minutes, the needles will be removed. Acupoints will include:
~GV.14
~LI.11 (bilateral)
~SP.6 (bilateral)
~SP.10 (bilateral)
~ST.36 (bilateral)
~Additional points may be added based on the symptom concerns reported."
16196462|NCT01422915|Drug|Colestipol|2 grams morning and bedtime for 90 days.
16196463|NCT01422902|Other|Plasticity-based Cognitive Training|
16196464|NCT01422902|Other|Non-plasticity-based Training|Computer games
16196465|NCT01422889|Device|ION™ Coronary Stent System|This study is intended to evaluate the ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System across a range of institutions and physician users to observe and assess subject outcomes and technology performance in a real-world setting.
16196466|NCT01422876|Drug|high dose FDC|once daily
16196467|NCT01422876|Drug|BI 10773 high dose|once daily
16196468|NCT01422876|Drug|high dose FDC placebo|once daily
16196469|NCT01422876|Drug|low dose FDC placebo|once daily
16196470|NCT01422876|Drug|high dose FDC placebo|once daily
16196471|NCT01422876|Drug|high dose FDC placebo|once daily
16196472|NCT01422876|Drug|low dose FDC placebo|once daily
16196473|NCT01422876|Drug|low dose FDC placebo|once daily
16196474|NCT01422876|Drug|high dose BI 10773 placebo|once daily
16196475|NCT01422876|Drug|low dose FDC|once daily
16196476|NCT01422876|Drug|high dose FDC placebo|once daily
16196477|NCT01422876|Drug|BI 10773 low dose|low dose once daily
16196478|NCT01422876|Drug|high dose BI 10773 placebo|once daily
16196479|NCT01422876|Drug|high dose BI 10773 placebo|once daily
16196480|NCT01422876|Drug|linagliptin|once daily
16196481|NCT01422876|Drug|low dose FDC placebo|once daily
16196482|NCT01422876|Drug|linagliptin placebo|once daily
16196483|NCT01422876|Drug|BI 10773 low dose placebo|once daily
16196484|NCT01422876|Drug|linagliptin placebo|once daily
16196485|NCT01422876|Drug|low dose BI 10773 placebo|once daily
16196486|NCT01422876|Drug|linagliptin placebo|once daily
16196487|NCT01422876|Drug|high dose BI 10773 placebo|once daily
16196488|NCT01422876|Drug|BI 10773 low dose placebo|once daily
16196489|NCT01422876|Drug|low dose BI 10773 placebo|once daily
16196490|NCT01422876|Drug|linagliptin placebo|once daily
16196527|NCT01422551|Behavioral|a psycho-educational control|a single-day psycho-educational seminar
16196491|NCT01422863|Behavioral|Lifestyle Intervention|Participants undergo 3 months of monitored exercise, consisting of aerobic and resistance training (3 days per week for 1 hour). Participants will also meet with a registered dietician, who will prescribe an American Heart Association low fat diet. The goal is to achieve a 1-2 lb weight loss per week.
16196492|NCT01422850|Biological|ALECSAT|Autologous activated CTL and NK-cells injected as three intravenous injections interspaced by 5 weeks.
16196493|NCT01422811|Behavioral|Multicomponent strategy to reduce avoidable length of stay|"The strategy comprises two integrated components:
~Distribution of two monthly reports, one consisting in the list of patients who, through data collection performed, are classified to be present on the ward although their clinical status is considered compatible with discharge; the other featuring individual length of stay profiles for each physician operating in the intervention arm (information taken from administrative data), allowing comparisons with the rest of the medical staff;
~Audits performed by professionals of each ward of the intervention arm designed to discuss cases judged to be compatible with discharge. The organization of this work are left to the wards, without any interference from the project team."
16196494|NCT01422811|Other|No intervention|No interventions (reporting, auditing) are planned; nevertheless control ward physicians know study aims and are informed about their patient's data collection.
16196495|NCT01422785|Drug|clindamycin phosphate 1.2%/tretinoin 0.025% gel alone|Once daily application of the clindamycin phosphate 1.2%/tretinoin 0.025% gel in the evening
16196496|NCT01422785|Drug|clindamycin phosphate 1.2%/tretinoin 0.025% gel plus benzoyl peroxide 6% foaming cloths|wash face with the benzoyl peroxide foaming cloth then rinse. then apply clindamycin phosphate 1.2%/tretinoin 0.025% gel. both done in the evening.
16196497|NCT01422772|Biological|VM202RY|0.5mg intramuscular injection
16196498|NCT01422772|Biological|VM202RY|1mg intramuscular injection
16196499|NCT01422772|Biological|VM202RY|2mg intramuscular injection
16196500|NCT01422759|Drug|Spironolactone|50-100 mg PO BID (X 12 weeks)
16196501|NCT01422746|Drug|Metformin|500-1000 mg PO BID (X12 weeks)
16196502|NCT01422733|Drug|Hydrocortisone|10mg/m2/per day PO at bedtime (X12 weeks)
16196503|NCT01422733|Drug|dexamethasone|1 mg PO twice
16196504|NCT01422733|Drug|Cosyntropin|250 micrograms IV twice
16196505|NCT01422733|Drug|rhCG|25 mcg IV twice
16196506|NCT01422720|Drug|Eslicarbazepine Acetate|ESL tablets (800 mg) QD
16196507|NCT01422707|Drug|Hydrocortisone|10 mg/m2/per day PO at bedtime (X4 weeks)
16196508|NCT01422681|Device|minimally invasive extracorporeal carbon dioxide removal|"The application of the extracorporeal carbon dioxide removal will be initiated by using a modified continuous veno-venous hemofiltration system equipped with a membrane lung with a total membrane surface of 1,35 m2 (Decap® Smart).
~Femoral vein is accessed via a double lumen catheter (14 F) inserted with the Seldinger technique and connected with the extracorporeal circuit. Blood flow is driven through the circuit by a roller nonocclusive low-flow pump (0- 450 ml/min) through a membrane lung (Euroset) that is connected to a fresh gas flow source delivering 100% oxygen at a constant rate of 8 l/min. Exiting the membrane lung, blood is driven to a hemofilter (Medica D250). The resulting plasmatic water is recirculated through the membrane lung by a peristaltic pump (0-155 ml/min)."
16196509|NCT01422668|Other|Khalas dates|every subject recieved 50 grams reducing carbohydrates equivalent of khalas dates
16196510|NCT01422642|Device|legacy posterior stabilized high-flexion (NexGen LPS-Flex)|NexGen legacy posterior stabilized high-flexion (NexGen LPS-Flex) total knee system
16196511|NCT01422642|Device|legacy posterior stabilized standard (NexGen LPS)|NexGen legacy posterior stabilized standard (NexGen LPS) total knee system
16196512|NCT01422629|Device|Ultrasonic ablation device|High Intensity focused ultrasound treatment
16196513|NCT01422616|Drug|Low-dose rtPA|Patients allocated to low-dose will receive 0.6 mg/kg (maximum of 60 mg) i.v. (15% bolus [maximum bolus dose of 9mg] and 85% infusion over 60 mins) recombinant tissue plasminogen activator (rtPA).
16196514|NCT01422616|Drug|Standard-dose rtPA|Patients allocated to standard-dose will receive 0.9 mg/kg (maximum of 90 mg) i.v. (10% bolus and 90% infusion over 60 mins) rtPA.
16196515|NCT01422616|Other|Intensive blood pressure (BP) lowering|"Intensive blood pressure (BP) lowering to a target systolic BP range 130-140 mmHg within one hour and to maintain this level for at least 72 hours (or until hospital discharge or death if this should occur earlier). A standardised i.v. BP lowering regimen using locally available and approved i.v. BP lowering agents will be used, commenced in the emergency department and later in a high dependency area (e.g. acute stroke or neurointensive care unit) as is usual for patients receiving rtPA.
~The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
16196516|NCT01422616|Other|BP management policies|"Patients allocated to the control group will receive management of BP that is based on a standard guideline, as published by the AHA. For this group, the attending clinician may consider commencing BP treatment if the systolic level is greater than 180 mmHg, however and the first line treatment will be oral (including nasogastric if required) and/or transdermal routes. Should control of systolic BP not be achieved via these routes, i.v. treatment may be started until the target systolic BP of 180 mmHg is achieved.
~The trial is an assessment of BP lowering management strategies, using routinely available drugs. There is some flexibility in the use of particular BP lowering agents to achieve BP targets."
16196517|NCT01422603|Drug|Clofarabine|Clofarabine preconditioning (40mg/m2 daily for 5 days) prior to full intensity allogeneic stem cell transplant
16196518|NCT01422603|Drug|Clofarabine|Clofarabine preconditioning (40mg/m2 daily for 5 days) prior to reduced intensity allogeneic stem cell transplant
16196519|NCT01422590|Drug|Sitagliptin|Single oral administration of sitagliptin 100 mg
16196520|NCT01422590|Drug|Mitiglinide|Single oral administration of mitiglinide 10 mg
16196521|NCT01422590|Drug|Sitagliptin, Mitiglinide|Concomitant administration of sitagliptin 100 mg and mitiglinide 10 mg
16196522|NCT01422577|Device|Bright Narrow Band Imaging|It is a High Definition system with narrow band imaging option in th endoscope.
16196523|NCT01422577|Device|White light Endoscopy|White light Endoscopy
16196524|NCT01422564|Device|Metal on Metal Hip System|Total hip arthroplasty with a metal on metal component system
16196525|NCT01422564|Device|Highly Cross Linked Polyethylene cup System|Total hip arthroplasty with Highly Cross Linked Polyethylene cup System
16196528|NCT01422538|Device|Ulthera® System|Focused ultrasound energy delivered below the surface of the skin on the lower face.
16196529|NCT01422538|Drug|Sculptra®|Injectable filler reconstituted prior to use. Injections are administered to the lower face in a combination of cross-hatching and fanning techniques. The Sculptra is injected in two treatment sessions 6 weeks apart.
16196530|NCT01422538|Other|Sculptra® treatment followed by Ultherapy™ treatment|Sculptra® administered in 2 injection sessions 6 weeks apart, then Ultherapy™ treatment 4 months following Sculptra.
16196531|NCT01422525|Procedure|spectral domain optical coherence tomography|RNFL thickness measurement using spectral domain optical coherence tomography at baseline, 1, 3 and 6 months postoperatively.
16196532|NCT01422512|Biological|seasonal influenza vaccine|Subjects received one single IM dose of trivalent Surface, Antigen, Inactivated, Influenza Vaccine Produced in Mammalian Cell Culture during the vaccination visit, according to the study protocol (follow-up period: until day 22) .
16196533|NCT01422499|Drug|zolinza/vorinostat|orally once per day (suspension of 50mg/ml or capsules of 100 mg vorinostat); starting dose will be 180 mg/m²/d; escalated with increments of 50 mg/m²/d every two weeks until dose limiting toxicity (grade 3 or 4 toxicity according to CTC) occurs or up to a maximum dose of 580 mg/m²/d; This dose will then be applied for 3 months. Patients without progression at first response evaluation will continue treatment for a maximum of 9 months.
16196534|NCT01422486|Drug|ezatiostat hydrochloride (Telintra®)|Three weeks of treatment with ezatiostat at 2000 mg per day in divided doses followed by a one week rest period in four-week treatment cycles.
16196535|NCT01422473|Device|EnSeal Trio Tissue Sealing Device|For surgery in ligating and dividing vascular tissue during abdominal surgery.
16196536|NCT01422460|Biological|Platelet Rich Plasma|"Platelet Rich Plasma (Preparation Rich in Growth Factors)
~intra articular injection 2ml
~Arms: Platelet Rich Plasma (Preparation Rich in Growth Factors)"
16196537|NCT01422447|Other|regular intervention|the subjects in the control group live in the used model
16196538|NCT01422447|Other|community intervention|in addition to regular intervention, those subjects in the intervention group will be given education intervention.
16196539|NCT01422434|Drug|LEO 90105 = calcipotriol + betamethasone dipropionate|Applied once daily for 4 weeks.
16196540|NCT01422434|Drug|Dovonex® = calcipotriol|Applied twice daily for 4 weeks.
16196541|NCT01422434|Drug|Rinderon® - DP = betamethasone dipropionate|Applied once daily for 4 weeks.
16196542|NCT01422421|Other|intensive control|use any medication to achieve systolic blood pressure less than 120mmHg and LDL cholesterol within 70-85mg/dl
16196543|NCT01422421|Other|standard control|use any medication to achieve systolic blood pressure less than 130mmHg and LDL cholesterol less than 100mg/dl
16196544|NCT01422408|Drug|Fluocinonide Cream|Given topically
16196545|NCT01422408|Procedure|Management of Therapy Complications|Receive fluocinonide cream
16196546|NCT01422408|Other|Questionnaire Administration|Ancillary studies
16196547|NCT01422395|Procedure|Freezing|Vitrification
16196548|NCT01422382|Drug|Pitavastatin (NK-104)|pitavastatin (NK-104) 4 mg once daily (QD)
16196549|NCT01422382|Drug|Diltiazem (Cardizem LA) 240 mg QD|Diltiazem (Cardizem LA) 240 mg QD
16196550|NCT01422369|Drug|Pitavastatin (NK-104)|Pitavastatin (NK-104) 4mg once daily (QD)
16196551|NCT01422369|Drug|Darunavir/Ritonavir (Prezista)|Darunavir/Ritonavir (Prezista) 800 mg/100 mg
16196552|NCT01422343|Procedure|percutaneous transluminal angioplasty femoro-popliteal|percutaneous transluminal angioplasty femoro-popliteal
16196553|NCT01422330|Drug|Etravirine|Type=exact number, unit=mg, number=100, form=tablet, route=oral use, 2 tablets. Type=exact number, unit=mg, number=200, form=tablet, route=oral use, 1 tablet. The drug is taken twice a day, after meals.
16196554|NCT01422317|Drug|EPA / DHA / Alpha-Tocopherol|Two gelatine capsules of Omacor-R (Pronova AS, Oslo) twice a day, each containing 850-882 mg eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) as ethylesters in the average ratio of EPA to DHA of 1:2. Alpha-Tocopherol (4 mg) was added to each capsule.
16196555|NCT01422317|Drug|Corn Oil / Alpha-Tocopherol (4 mg)|Two gelatine capsules twice a day. Each capsule contains 1g Corn Oil and 4 mg Alpha-Tocopherol
16196556|NCT01422304|Drug|Sugammadex|Sugammadex 4 mg/kg intravenously
16196557|NCT01422304|Drug|neostigmine and glycopyrrolate or atropine|Neostigmine and glycopyrrolate or neostigmine and atropine administered intravenously per usual practice and per the product labels
16196558|NCT01422304|Drug|Placebo to neostigmine|Normal saline (NaCl 0.9%)
16196559|NCT01422304|Drug|Placebo to sugammadex|Normal saline (NaCl 0.9%)
16196560|NCT01422291|Drug|paracetamol|1 gr
16196561|NCT01422291|Drug|morphine|0.1mg/kg intravenous in 100 ml serum physiologic
16196562|NCT01422291|Drug|Dexketoprofen|50 mg
16196563|NCT01422291|Drug|Paracetamole|1 gr
16196564|NCT01422278|Other|Rehabilitation|Three weeks of rehabilitation in Hospital.
16196565|NCT01422252|Device|Vigi'Fall®|Precocious fall detection device
16196566|NCT01422239|Behavioral|Tailored treatment|8 sessions of individual behavioral counseling. The first 3 sessions will be 45 minutes long and include 30 minutes tailored to the perceived risks of quitting most strongly held by each participant. The final 5 sessions will be 30 minutes long and include material from the Mayo Clinic's smoking cessation manual.
16196567|NCT01422239|Behavioral|Standard Treatment|8 sessions of individual behavioral counseling. The first 3 sessions will be 45 minutes long and include 30 minutes focused on the benefits of quitting smoking. The final 5 sessions will be 30 minutes long and include material from the Mayo Clinic's smoking cessation manual.
16196568|NCT01422226|Drug|Misoprostol|Experimental: 400 mcg taken sublingually 2 hours prior to IUD insertion
16196569|NCT01422226|Other|Placebo|Pill identical to study drug in appearance, taste, smell. Taken sublingually 2 hours prior to IUD insertion
16196570|NCT01422213|Drug|Placebo|capsules; daily; orally
16196571|NCT01422213|Drug|Vortioxetine (Lu AA21004)|encapsulated tablets; daily; orally
16196572|NCT01422213|Drug|Vortioxetine (Lu AA21004)|encapsulated tablets; daily; orally
16196573|NCT01422200|Biological|2011-2012 seasonal flu vaccine Subcutaneous|
16196574|NCT01422200|Biological|2011-2012 seasonal flu vaccine Intramuscular|
16196575|NCT01422187|Drug|Taliglucerase alfa|Taliglucerase infusion every two weeks for 21 months
16197009|NCT01418599|Drug|Torrent's Alfuzosin Extended Release Tablet|
16196576|NCT01422174|Procedure|Implantable Cardio Defibrillator (ICD),|Standard ICD implantation (as per clinical decision)
16196577|NCT01422161|Drug|Botulinum Toxin commonly known as BOTOX®|"A total dose between 200-300 units of Botulinum toxin will be administered across 12 muscles of the affected hand.
~There will be 1 treatment cycle during the 9 week study."
16196578|NCT01422161|Drug|Placebo|The control group will receive a placebo injection.
16196579|NCT01422148|Drug|Amiodarone|oral amiodarone (400 mg twice daily for 7 days, then 200 mg twice daily for the next 7 days
16196580|NCT01422148|Drug|Minocycline|intravenous minocycline 100 mg daily x 5 days starting intra-operatively combined with oral amiodarone (400 mg twice daily for 7 days, then 200 mg twice daily for the next 7 days
16196581|NCT01422135|Drug|AG200-15|A transdermal contraceptive delivery system for levonorgestrel (LNG) and ethinyl estradiol (EE). . A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.
16196582|NCT01422122|Drug|Vitamin D3|4000 mg per day, one tablespoon syrup per day
16196583|NCT01422122|Drug|Placebo|one table spoon Syrup per day
16196584|NCT01422109|Drug|YH14659|YH14659 capsule by oral
16196585|NCT01422109|Drug|clopidogrel & aspirin|clopidogrel tablet(75mg) + aspirin capsules(100mg) by oral
16196586|NCT01422096|Drug|Leuprolide|depot leuprolide 11.25 mg if less than or equal to 37.5 kg or 15 mg if > 37.5 kg im once
16196587|NCT01422083|Procedure|home stretching program|A home stretching program (sleeper's stretch): 3 x 30 seconds, once a day for 6 weeks.
16196588|NCT01422018|Drug|Avastin (bevacizumab)|Bevacizumab (1.25 mg in 0.05 ml) (Avastin; Genentech Inc., San Francisco, CA, USA)
16196589|NCT01422005|Other|Simultaneous Bimanual training|"Patients who have had a stroke and are in the Device group will undergo 12 weeks of training using the devices.
~Patients who have had a stroke and are in the Control group, will undergo 12 weeks of conventional therapy."
16196590|NCT01422005|Other|Conventional Occupational Therapy|Conventional Occupational Therapy will be given to patients in the control group.
16196591|NCT01421992|Drug|Methylphenidate|One Tablet of methylphenidate, 20 mg per day during 3 weeks
16196592|NCT01421992|Drug|Placebo|one tablet placebo per day during 3 weeks
16196593|NCT01421979|Dietary Supplement|Energy Drink, Taurine, Caffeine|
16196594|NCT01421966|Biological|CureXcell®|CureXcell® injection will be administered about every 4 weeks for up to 4 treatments, or until until ulcer closure, whichever occurs first.
16196595|NCT01421966|Biological|Sham injection|The sham injections will be made by pressing on the ulcer with a needle connected to an empty syringe, at each cm of the ulcer bed
16196596|NCT01421953|Device|CT-simulation and 4D PET-CT|Patients will do a CT-simulation and 4D PET-CT in radiotherapy treatment position. The target volumes and the dosimetries obtained with both modalities will be compared.
16196597|NCT01421940|Drug|Placebo drug|After total mesorectal excision for rectal cancer, patients take placebo drug five time per week for 12 weeks.
16196598|NCT01421940|Drug|Udenafil|After total mesorectal excision, patients take 50mg udenafil five times per week for 12 weeks.
16196599|NCT01421927|Drug|Lenalidomide|"Start between Day+100 and Day+120 post-transplant
~- Initial dose: 5 mg/day every day
~In the absence of thrombocytopenia < 75000/mm3 or neutropenia < 1000/mm3 (with or without G-CSF), increase to the upper level than the ongoing one every third month up to the maximal dose of 15 mg/day every day.
~- Duration
~until persistent stringent complete response for 3 months
~or progression defined by IMWG criteria12
~or unacceptable toxicity
~or one year after transplant"
16196600|NCT01421914|Other|Bupivacaine 0,5%|The study method was a step-up/step-down sequence model where the dose for following patients was determined by the outcome of the preceding block. The starting dose of bupivacaine was 5 mL per nerve. In the case of block failure, the dose was increased by 0.5 mL per nerve. Conversely, block success resulted in a reduction in dose by 0.5 mL per nerve. Each of the three nerves was treated as a separate entity. Dose adjustments were made to each nerve individually. The volume dose was increased in 0.5 mL at every 5 consecutive cases regardless of the result of the previous block in order to minimize bias occurence. A blinded assistant assessed sensory and motor blockade at 5-min intervals up to 30 min.
16196601|NCT01421901|Drug|Ertapenem|Ertapenem i.v,m 1g, once a day, 3 days
16196602|NCT01421901|Procedure|appendectomy|
16196603|NCT01421875|Genetic|DNA methylation analysis|
16196604|NCT01421875|Genetic|RNA analysis|
16196605|NCT01421875|Genetic|gene expression analysis|
16196606|NCT01421875|Genetic|microarray analysis|
16196607|NCT01421875|Genetic|nucleic acid sequencing|
16196608|NCT01421875|Other|laboratory biomarker analysis|
16196609|NCT01421862|Genetic|DNA methylation analysis|
16196610|NCT01421862|Genetic|RNA analysis|
16196611|NCT01421862|Genetic|gene expression analysis|
16196612|NCT01421862|Genetic|microarray analysis|
16196613|NCT01421862|Genetic|mutation analysis|
16196614|NCT01421862|Genetic|nucleic acid sequencing|
16196615|NCT01421862|Other|laboratory biomarker analysis|
16196616|NCT01421849|Procedure|Denture implantation|"In a preliminary phase, a new denture is made according to standardized prosthodontic protocol or the old denture is adapted to provide a well-fitting denture.
~Eight weeks after insertion of the new denture an implant is placed under local anaesthetics in the centre of the mandibula.If primary stability is good, the implant is immediately loaded by the denture. If not, the implant is loaded after 6 to 12 weeks. Before, during and after the treatment patient satisfaction is evaluated by a 20 item questionnaire. Afterwards questionnaires are compared. After the insertion of the implant clinical evaluations take place at several moments.
~The total duration of the study will be 12 to 18 months."
16196617|NCT01421836|Procedure|ERCP-guided stent insertion|ERCP guided stent insertion for malignant biliary obstruction
16196618|NCT01421836|Procedure|EUS guided stent insertion|EUS-guided stent insertion for malignant biliary obstruction
16196619|NCT01421823|Drug|alpha agonist ointment|2 weeks local treatment with alpha agonist ointment
16196620|NCT01421823|Drug|Placebo|2 weeks local treatment with placebo ointment
16196621|NCT01421810|Drug|Dexamethasone|1 mg PO
16196622|NCT01421810|Drug|rhCG|25 mcg IV
16196623|NCT01421797|Drug|Dexamethasone|1 mg PO
16196624|NCT01421797|Drug|Cortrosyn|single IV bolus of 0.25 mg will be administered
16196626|NCT01421771|Drug|Antihypertensive Agents|"Study formulary consists of ACE/ARB, Beta Adrenergic Blocker, Calcium Channel Blocker, vasodilators, peripheral alpha antagonist and central alpha agonist.
~ACE I or ARB is first line, the order of addition of subsequent medications is per the discretion of the investigator"
16196627|NCT01421771|Other|Dry weight Challenge|Reduce the estimated dry weight of the patient's progressively over 2 -week intervals until the dry weight challenge is no longer tolerated or the patient is at BP goal
16196628|NCT01421771|Dietary Supplement|Extend dialysis treatment time and re-challenge estimated dry weight|Extend dialysis treatment time and re-challenge estimated dry weight
16196629|NCT01421758|Behavioral|online social network enrollment plus education and self monitoring|Participants are enrolled in an online social network designed to increase social support for physical activity and will self monitor physical activity and receive educational materials at a dedicated study website.
16196630|NCT01421758|Behavioral|Web education control|Participants will receive access to a dedicated study website where they can view educational materials related to physical activity
16196631|NCT01421745|Other|Cultural Competence Education module|A four hour cultural competence education module including lecture, case studies, and discussion of cultural competence.
16196632|NCT01421719|Drug|Cystoscopic injection of Botox into the urinary bladder|100 U of Botox A injected transurethrally into the urinary bladder muscle and submucosa.
16196633|NCT01421706|Drug|Sibutramine-clopidogrel|Sibutramine-clopidogrel
16196634|NCT01421706|Drug|sibutramine-Clarithromycin|sibutramine-Clarithromycin
16196635|NCT01421693|Drug|Ceftriaxone|"≥2-<14 years - 60mg/kg/ once daily for 7 days
~14 years and older - 2g once daily for 7 days
~Intravenous infusion. Vials of crystalline powder."
16196636|NCT01421693|Drug|Gatifloxacin|Gatifloxacin 10 mg/kg/day for 7 days. Tablets for oral administration.
16196637|NCT01421680|Dietary Supplement|Ensure powder|Ensure powder(500kcal) per day for 7 weeks
16196638|NCT01421667|Drug|brentuximab vedotin|1.8 mg/kg every 3 weeks by IV infusion
16196639|NCT01421667|Drug|rituximab|375 mg/m2 every 3 weeks by IV infusion
16196640|NCT01421654|Device|S9 Elite with Acclimate|S9 Elite Flow Generator with Acclimate feature activated
16196641|NCT01421654|Device|S9 Elite|S9 Elite Flow Generator
16196642|NCT01421641|Drug|Intracervical Lidocaine Injection|Injection of 2 cc of 1% lidocaine solution at the anterior lip of the cervix using a standard 22 gauge spinal needle
16196643|NCT01421641|Drug|Topical Lidocaine Gel|Application of 1cc of 2% lidocaine gel to the anterior lip of the cervix with a Q-tip
16196644|NCT01421628|Other|Fitness exercise program|Exercise program, daily frequency, duration of 6 weeks.
16196645|NCT01421615|Drug|Vaginal capsules of lactobacilli|The patients in one-course group who were BV positive would receive the first course treatment of vaginal lactobacillus capsule and be repeatedly evaluated BV status after treatment. If their BV test result were still positive after one-course treatment, they would NOT receive any treatment but would be followed up to the 4th-7th days of postpartum.
16196646|NCT01421615|Drug|Vaginal capsules of lactobacilli|The patients in two-course group who were BV positive would receive the first course treatment of vaginal lactobacillus capsule and be repeatedly evaluated BV status after treatment. If their BV test result were still positive after one-course treatment, they will receive the second course treatment of Lactobacilli preparation.
16196647|NCT01421589|Drug|Growth hormone treatment|Growth hormone 0.4 mg once daily (titrated to IGF-1) by sub-cutaneous injection for 12 weeks.
16196648|NCT01421576|Dietary Supplement|High fat meal|offer high fat-meal in the morning before drug intake.
16196649|NCT01421563|Drug|Anplag|Sarpogrelate HCl 300mg once a day or 100mg three times a day
16196650|NCT01421550|Procedure|Conservative treatment|Patients that randomize for conservative management of their umbilical hernia will be followed routinely at the polyclinical ward.
16196651|NCT01421550|Procedure|Surgical repair|Patients that randomize for surgical repair of their umbilical hernia will be operated in an elective setting after a careful preoperative work-up.
16196652|NCT01421524|Drug|CC-122|CC-122 dose in both arms will increase by 1 mg increments starting with 3 mg 5/7 days using the 3+3 design in dose escalation phase. A dose-level -1, with a starting dose of 2mg, may also be evaluated if the opening dose level is not tolerated. At all dose levels in MM-2b arm, DEX will be combined with CC-122 at a starting dose dependent on the subject's age: for subjects who are ≤ 75 years of age, DEX 40 mg/day will be given on Days 1, 8, 15 and 22 of a 28-day cycle and for subjects who are > 75 years of age, DEX 20 mg/day will be given on Days 1, 8, 15 and 22 of a 28-day cycle. Approximately 33 subjects will be enrolled in the dose escalation phase (15 in each treatment arm). An additional intermittent schedule of 21/28 days may be evaluated per Safety Review Committee (SRC) decision. Following dose escalation, one or two arms will be expanded at or below the MTD in up to 28 subjects (14 subjects in each arm).
16196653|NCT01421524|Drug|CC-122|One or more intermittent schedules of CC-122 either given 5 continuous days out of 7 per week (5/7 days) or 21 continuous days out of 28 days per cycle (21/28 days). Following dose escalation, one or more of these intermittent schedules will be evaluated at a starting dose of 4 mg.
16196654|NCT01421524|Drug|CC-122|Dose escalation on a continous schedule will be evaluated at a starting dose of 4 mg. Specifically, dose levels with 1 mg increments (eg 4mg, 5mg, 6mg etc.) will be evaluated using a 3+3 design as detailed in Part A of the protocol .
16196655|NCT01421524|Drug|CC-122|Up to 10 subjects with relapsed or refractory PCNSL will be enrolled to a PCNSL cohort to evaluate intermittent schedules of CC-122 and to further explore preliminary signals of efficacy and biomarker hypotheses.
16196656|NCT01421511|Drug|TR-701 FA|"TR-701 FA 200 mg once daily in 250 mL sterile saline for injection as a 60 minute IV infusion
~TR-701 FA Tablets, 200 mg, orally once daily"
16196657|NCT01421511|Drug|Linezolid|"Linezolid 600 mg IV Injection twice daily in 300 mL sterile saline for injection as a 60 minute IV infusion
~Linezolid Tablets, 600 mg, orally every 12 hours"
16196658|NCT01421498|Drug|Lifitegrast|Dosage Form: Ophthalmic Solution Dosage: 5.0% Frequency: BID Duration: 12 weeks
16196659|NCT01421498|Drug|Placebo|Dosage Form: Ophthalmic Solution Frequency: BID Duration: 12 weeks
16196660|NCT01421485|Behavioral|Integrated treatment program|CBT, psychopharmacological treatment, family treatment, HIV prevention, case management
16196661|NCT01421485|Behavioral|Treatment as Usual|Treatment in community, case management
16197010|NCT01418586|Drug|Torrent's Alfuzosin Extended Release Tablet|
16196662|NCT01421472|Drug|MM-121|MM-121 IV at 40 mg/mg loading dose on Cycle 1, Week 1 followed by 20 mg/mg weekly for all subsequent doses
16196663|NCT01421472|Drug|Paclitaxel|Standard dosing of paclitaxel IV, followed by standard dosing of doxorubicin IV plus cyclophosphamide IV, followed by surgery.
16196664|NCT01421459|Drug|LY2963016|Administered subcutaneously
16196665|NCT01421459|Drug|Lantus|Administered subcutaneously
16196666|NCT01421459|Drug|OAMs|Administered orally
16196667|NCT01421433|Drug|Tandrilax|Tandrilax (caffeine, carisoprodol, sodium diclofenac, paracetamol). Tablets, administered 3 times a day, for 7 consecutive days.
16196668|NCT01421433|Drug|Dolamin Flex|Dolamin Flex (lysine clonixinate and cyclobenzaprine). Tablets, administered 3 times a day, for 7 consecutive days.
16196669|NCT01421407|Device|Ultrasonic ablation device|High Intensity Focused Ultrasound treatment
16196670|NCT01421368|Drug|Tenofovir 1% vaginal gel|Tenofovir 1% gel is supplied as a clear, transparent, viscous gel packaged in pre-filled single use applicators. Each applicator contains 4.0 mL of tenofovir gel (equal to 4.4 gm) at a concentration of 1% (weight for weight) formulated in purified water with edetate disodium, citric acid, glycerin, methylparaben, propylparaben and hydroxyethylcellulose, and is pH adjusted to 4-5
16196671|NCT01421368|Drug|Depo-medroxyprogesterone acetate (DMPA)|DMPA is an intramuscular injectable contraceptive containing 150 mg of medroxyprogesterone acetate. It is FDA approved for 12 weeks of use per injection.
16196672|NCT01421368|Drug|Oral contraceptive: LNG 150 mcg and EE 30 mcg|Each pill contains LNG 150 mcg (the active levorotatory enantiomer of norgestrel) and EE 30 mcg. Each pack contains 21 active pills and 7 placebo pills
16196673|NCT01421355|Drug|Atazanavir|The study design is a single arm, open label trial. Treatment is atazanavir 300 mg BID per day for 4 days. The Brigham and Women's Hospital Investigational Drug Service (IDS) will dispense study drug.
16196674|NCT01421342|Drug|Switching: Bupropion-SR|Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases.
16196675|NCT01421342|Drug|Augmenting: Antidepressant + Bupropion-SR|"Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment, or adjust depending on response or side effect profile for up to 36 weeks.
~And
~Bupropion-SR (Dose: 150 mg - 400 mg taken per day orally for up to 36 weeks): Initiating with bupropion-SR dose of 150 mg, then increasing dose per protocol up to 400 mg (200 mg BID), maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases."
16196676|NCT01421342|Drug|Augmenting: Antidepressant + Aripiprazole|"Current antidepressant (either a SSRI or a SNRI or mirtazapine): Continue the dose prescribed at time of enrollment or adjust depending on response or side effect profile for up to 36 weeks.
~And
~Aripiprazole (Dose: 2 mg - 15 mg taken orally once per day for up to 36 weeks): Initiating with aripiprazole dose of 2 mg for one week, then increasing dose per protocol up to 15 mg, maintaining or decreasing dose for up to 36 weeks depending on response and side effect profile through the acute and continuation phases."
16196677|NCT01421316|Radiation|Whole brain radiotherapy with volumetric arc therapy|Whole brain radiotherapy with volumetric arc therapy is used.
16196678|NCT01421303|Drug|Enbrel|Enbrel
16196679|NCT01421290|Procedure|Surgery|Knee surgery
16196680|NCT01421290|Other|Conservative comparator|Kinesitherapy, intra-articular injection, wearing a brace, thermotherapy, intake of supplements.
16196681|NCT01421277|Drug|Statin Therapy|Investigator's choice of any statin.
16196682|NCT01421264|Drug|Gabapentin|300mg capsules by mouth
16196683|NCT01421238|Behavioral|Survey|Participants were randomized to one of two survey groups. In one arm (resuscitation default arm), resuscitation was presented as the course of action that would be followed unless the participant objected. In the other arm (comfort care default arm), comfort care was presented as the course of action that would be followed unless the participant objected.
16196684|NCT01421225|Device|Closed-loop Insulin Pump therapy|Subjects insulin doses were adjusted based on a proportional-integral-derivative algorithm using the continuous glucose monitor readings from 10 PM - noon.
16196685|NCT01421225|Device|Standard Insulin Pump Therapy|Subjects insulin doses followed their usual home routine.
16196686|NCT01421212|Biological|Hepatitis B Immune Globulin (Boca HBVIg)|"Phase I (12 weeks): Intravenous Boca HBVIg 10,000 IU administered intraoperatively during the anhepatic phase, following reperfusion, daily on days 1-7, once during week 4 and once during week 8 (total of 11 doses).
~Phase II (24 weeks): Starting at 12 weeks post liver transplantation, Boca HBVIg will be reduced to 5,000 IU given intravenously on a monthly basis for patients who had an anti-HBs trough titer greater than or equal to 500 IU/L at 8 weeks without the need for additional Boca HBVIg doses. Patients with an 8 week trough level less than 500 IU/L will receive 10,000 IU Boca HBVIg every 4 weeks for the remainder of the study."
16196687|NCT01421199|Procedure|Myringotomy|tube placement for children with multiple ear infections
16196693|NCT01421173|Drug|Vorinostat|Starting dose: 200 mg by mouth on Days -8 to -2.
16196694|NCT01421173|Drug|Gemcitabine|Starting dose: 2175 mg/m2 by vein on Days -8 and -3. This includes the gemcitabine 75 mg/m2 loading dose.
16196695|NCT01421173|Drug|Busulfan|"AUC: 4,000 micrometer (microM).min/day, or 105 mg/m2/day) on Days -8 to -5.
~Pharmacokinetics will be performed with the first dose of 32 mg/m2 by vein on Day -8. The doses on Days -6 and -5 will be subsequently adjusted to target an AUC of 4,000 microMol.min-1. In the event that PK adjusting not possible, a dose of busulfan of 105 mg/m2 will be administered on days -6 and -5."
16196696|NCT01421173|Drug|Melphalan|60 mg/m2 by vein on Days -3 and -2.
16196697|NCT01421173|Procedure|Stem Cell Infusion|Infusion of stem cells by vein on Day 0.
16196698|NCT01421173|Drug|Rituximab|375 mg/m2 on days +1 and +8 for patients with CD20+ tumors.
16196699|NCT01421173|Drug|G-CSF|5 mcg/kg/day (rounded up the nearest vial) subcutaneously beginning on Day +5 and continuing until neutrophil recovery is documented.
16196700|NCT01421173|Drug|Palifermin|60 mcg/kg by vein daily for 6 doses. Three doses administrated prior to start chemo (24 hours must elapse between the last dose and first therapeutic dose of chemo) and three doses after the last chemo starting on day 0.
16196701|NCT01421173|Drug|Dexamethasone acetate|8 mg by vein twice a day from day -8 AM to day -2 PM.
16196702|NCT01421160|Drug|sodium citrate and citric acid|sodium citrate and citric acid equivalent to 1 mEq/ml bicarbonate (usual dose 10-30 mls/day diluted with water)
16196703|NCT01421147|Drug|LY2963016|Administered subcutaneously
16196704|NCT01421147|Drug|Lantus|Administered subcutaneously
16196705|NCT01421147|Drug|Insulin Lispro|Administered subcutaneously
16196706|NCT01421134|Drug|Lurasidone|20, 40, 60 mg, flexible dose, once daily PM 6 weeks
16196707|NCT01421134|Drug|Placebo|Placebo
16196708|NCT01421121|Biological|100U EV71 vaccine with adjuvant|inactivated vaccine (vero cell) against EV71 of 100U /0.5ml, two doses, 28 days interval
16196709|NCT01421121|Biological|200 U EV71 vaccine with adjuvant|inactivated vaccine (vero cell) against EV71 of 200U /0.5ml, two doses, 28 days interval
16196710|NCT01421121|Biological|400U EV71 vaccine with adjuvant|inactivated vaccine (vero cell) against EV71 of 400U /0.5ml, two doses, 28 days interval
16196711|NCT01421121|Biological|200U EV71 vaccine without adjuvant|inactivated vaccine (vero cell) against EV71 without adjuvant of 200U /0.5ml, two doses, 28 days interval
16196712|NCT01421121|Biological|Placebo|0.5ml placebo, two doses, 28 days interval
16196713|NCT01421108|Behavioral|Framing (Gain-framed messages)|"The adolescents will randomly assign to three groups: gain-framed message and loss- framed message. Each group of adolescents will read the respective pamphlets with the exception of the control group. The gain-framed pamphlet contains six positive messages with three related full-color images(6.1 X 4.5). The gain-framed pamphlet, entitled The Benefits of good oral hygiene, emphasizes the benefits of brushing, and flossing."
16196714|NCT01421108|Behavioral|Framing (Loss-framed messages)|"The adolescents will randomly assign to three groups: gain-framed message , loss- framed message and a control group. Each group of adolescents will read the respective pamphlets with the exception of the control group.
~The loss-framed pamphlet contains six negative messages with three related full-color images (6.1 X 4.5). The loss-framed pamphlet, entitled The disadvantages of poor oral hygiene, emphasizes the costs of not brushing and flossing."
16196715|NCT01421095|Drug|recombinant FSH|Each participant will recieve recombinant FSH (150 IU) intravenously
16196716|NCT01421082|Device|Lung Volume Reduction Coil (LVRC) (PneumRx, Inc.)|Lung Volume Reduction Coil (LVRC)
16196717|NCT01421069|Drug|etanercept|"Subjects aged <18 years and less than or equal to 62 kg will receive etanercept SC at a dose of 0.8 mg/kg QW (up to a maximum dose of 50 mg QW).
~Subjects aged greater than or equal to 18 years or >62 kg will receive etanercept SC at a dose of 50 mg QW."
16196718|NCT01421056|Drug|CHF 5074 1x|oral tablet, 1x, once a day in the morning for 24 weeks
16196719|NCT01421056|Drug|CHF 5074 2x|oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 20 weeks
16196720|NCT01421056|Drug|CHF 5074 3x|oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 16 weeks
16196721|NCT01421043|Drug|triazolam liquid oral drops|0.25 mg single dose oral drops
16196722|NCT01421043|Drug|triazolam tablets|0.25 mg single oral dose
16196723|NCT01421030|Procedure|Percutaneous pulmonary valve implantation or open heart surgery|Outcomes before percutaneous pulmonary valve implantation or open heart surgery before, 1, 3, 6 and 12 months after the treatment
16196724|NCT01421017|Radiation|Radiation|
16196725|NCT01421017|Drug|Imiquimod|
16196726|NCT01421017|Drug|Cyclophosphamide|
16196727|NCT01421004|Drug|TKI258|
16196728|NCT01420978|Procedure|CSF Diversion|CSF drainage
16196729|NCT01420965|Drug|CT-011 (Anti-PD1 Antibody)|Immune Enhancer
16196730|NCT01420965|Other|Sipuleucel-T (Provenge)|Vaccine
16196731|NCT01420965|Drug|Cyclophosphamide|Low dose- Immune Enhancer
16196732|NCT01420952|Drug|[11C]LY2428703|
16196733|NCT01420926|Drug|Bortezomib|Given SC
16196734|NCT01420926|Drug|Decitabine|Given IV
16196735|NCT01420926|Other|Laboratory Biomarker Analysis|Correlative studies
16196736|NCT01420926|Other|Pharmacological Study|Correlative studies
16196737|NCT01420926|Other|Quality-of-Life Assessment|Ancillary studies
16196738|NCT01420926|Other|Questionnaire Administration|Ancillary studies
16196739|NCT01420913|Drug|Pregabalin|Pregabalin 300mg a day
16196740|NCT01420900|Device|THA with ABG II / Trident|Surgery with total hip arthroplasty in the form of ABG II / Trident
16196741|NCT01420900|Device|THA with CLS / Trilogy|Surgery with total hip arthroplasty in the form of CLS / Trilogy
16196742|NCT01420887|Procedure|Continuous Passive Motion|Continuous passive motion.
16196743|NCT01420887|Procedure|Physical Therapy|Physical therapy.
16196744|NCT01420874|Drug|FOLFOX6|IV administration of 85 mb/m(2) oxaliplatin and 400 mg/m(2) leucovorin over 120 mins, followed by 400 mg/m(2) 5-fluorouracil (FU) bolus then 2400 mg/m(2) 5-FU as a 46 hr infusion. All patients must have central intravenous acess (e.g. mediport, PICC line) for continuous infusion of 5-FU. Adv. colorectal and pancreatic pts. w/no other standard chemo available, & in pts who cannot receive FOLFOX chemo, immunotherapy may be given w/o antecedent chemo.
16196745|NCT01420874|Biological|EGFRBi armed ATC Infusions|Armed ATC will be infused intravenously (IV) with the rate of infusion based on the endotoxin content of the product. All patients will be observed for at least 4 hours after an infusion. Armed ATC infusions will begin 3 weeks after chemotherapy and subsequent doses will be administered once weekly, for 3 weeks, then 12 weeks post aATC#1. Dose escalation level(per infusion): Level 0-5 billion; Level 1-10 billion; Level 2-20 billion; Level 3-40 billion
16196746|NCT01420861|Drug|GTx-758|two GTx 758 tablets per day
16196747|NCT01420848|Other|Auriculotherapy|Auriculotherapy stimulates points to achieve better emotional balance, mental and physiological.
16196748|NCT01420848|Other|Placebo Group|They were evaluated at the baseline,twelve sessions and 15-day follow-up and received 12 sessions through the Fist and Outer ear points.
16196749|NCT01420835|Other|Auriculotherapy (protocol group)|The auriculotherapy points of the protocol group will be 5 points (Liver yang1, Liver yang2, Shenmen, Kidney, Brainstem), during 45 days, twice per week, 12 sessions and assessment of the follow-up (30 days) after finishing the treatment.
16196750|NCT01420835|Other|without protocol group|The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion. Five points will be chosen to treat stress according to the symptoms and the Chinese diagnosis.
16196751|NCT01420822|Drug|Fluticasone|Collection of safety data
16196752|NCT01420796|Other|Swallowing exercise|"Patients will perform oral motor exercises for swallowing muscles for five weeks, four days a week.
~This exercises aim to increase strength and range of motion of mouth, larynx and pharynx structures. All patients will make sustained vowel phonation of /a/, pushing plosive phonemes /pa/, /ta/, /ka/ in a forceful manner, suction of wet gauze, swallowing with tongue hold and modified supraglottic maneuver, in ten repetitions, ascending and descending gliding phonation of vowel /a/ and /u/, five repetitions of each vowel, and tongue rotation in oral vestibule, 3 series of 5 repetitions to each side."
16196753|NCT01420796|Other|Breathing Exercises|Patients will perform expiratory muscle training. Initial load will be 30% of maximal expiratory pressure which will increase until 75%. This load will be keep until end of training. Patients will made the exercises for 30 minutes with three minutes of training and two of rest.
16196754|NCT01420796|Other|Swallowing and breathing exercises|For five weeks, patients will perform swallowing and breathing exercises that follow: expiratory muscle training and sustained vowel phonation of /a/, pushing plosive phonemes /pa/, /ta/, /ka/ in a forceful manner, suction of wet gauze, swallowing with tongue hold and modified supraglottic maneuver, in ten repetitions, ascending and descending gliding phonation of vowel /a/ and /u/, five repetitions of each vowel, and tongue rotation in oral vestibule, 3 series of 5 repetitions to each side.
16196755|NCT01420783|Drug|SAR302503|"Pharmaceutical form:capsule
~Route of administration: oral"
16196756|NCT01420770|Drug|SAR302503|"Pharmaceutical form:capsule
~Route of administration: oral"
16196757|NCT01420757|Procedure|incisional hernia repair|Tension-free open or laparoscopic incisional hernia repair
16196758|NCT01420744|Drug|BT086|"BT086 will be administered per intravenous infusion (IV). The dose to be administered is 3.65 mL /kg bw/day and is calculated by the mean Immunoglobulin M (IgM) content of BT086 which is 23%.
~Infusion rate:
~Starting rate is 0.1 mL/min. Maximum infusion rate is 0.5 mL/min (target infusion rate) Treatment will be administered over a 5-day period."
16196759|NCT01420744|Drug|1% Human Albumin infusion|"1% Albumin will be administered per intravenous infusion (IV). The dose to be administered is 3.65 mL /kg bw/day.
~Infusion rate:Starting rate is 0.1 mL/min. Maximum infusion rate is 0.5 mL/min (target infusion rate). Rate is to be raised in steps of 0.1 mL every 10 min until the target infusion rate is reached.
~Treatment will be administered over a 5-day period.
~Starting rate is 0.1 mL/min. Maximum infusion rate is 0.5 mL/min (target infusion rate)"
16196760|NCT01420718|Drug|MTA|partial pulpotomy using White ProRoot MTA. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material.
16196761|NCT01420718|Drug|iRoot BP|Partial pulpotomy using iRoot BP. Partial pulpotomy includes removal of 1mm of coronal pulp and covering the remaining tissue with a suitable material. Bioaggregate is the first nano particle, water based root end filling material. This product includes calcium silicate, calcium hydroxide, hydroxy apatite and Tantalum oxide. Compared to MTA,this material lacks Bismuth oxide and calcium aluminate. iRoot BP is the injectable for of Bioaggregate (Injectable Root Bioaggregate Paste).
16196762|NCT01420692|Drug|Gliclazide MR|Doses between 30 mg to 120 mg/day p.o. Gliclazide MR will be arranged according to the target glycemic levels.
16196763|NCT01420692|Drug|Insulin Detemir|Early initiation of s.c. insulin detemir in contrast to Gliclazide MR. Insulin detemir treatment will be exchanged to Gliclazide MR after 12 weeks.
16196764|NCT01420679|Drug|Pralatrexate Injection|"Intravenous (IV) push administration over 30 seconds to 5 minutes via a patent IV line containing normal saline (0.9% sodium chloride).
~Initial dose: 30 mg/m2
~Administered weekly for 3 weeks of a 4-week cycle until criteria for discontinuation per the protocol are met."
16196765|NCT01420666|Drug|Acetaminophen|Acetaminophen 325 mg, three tablets four times a day, orally, with food
16196766|NCT01420666|Drug|Maxigesic 325|Maxigesic 325 (Acetaminophen 325 mg+ ibuprofen 97.5mg), three tablets four times a day, orally, with food
16196767|NCT01420666|Drug|Ibuprofen|Ibuprofen 97.5mg, three tablets four times a day, orally, with food
16196768|NCT01420666|Drug|Placebo|placebo, three tablets four times a day, orally, with food
16196769|NCT01420653|Drug|Maxigesic 325|Maxigesic USA (acetaminophen 325 mg + ibuprofen 97.5mg), three tablets four times a day with food for 48 hours
16196770|NCT01420653|Drug|Acetaminophen|Acetaminophen 325 mg, 3 tablets four times a day, with food for 48 hours
16196771|NCT01420653|Drug|Ibuprofen|Ibuprofen 97.5mg, three tablets four times a day, with food for 48 hours.
16196772|NCT01420653|Drug|Placebo|placebo, three tablets four times a day, with food for 48 hours
16196773|NCT01420640|Behavioral|Lower frequency, shorter period of Tai Chi|12 weeks of supervised Tai Chi classes, 1x/week
16196774|NCT01420640|Behavioral|Higher frequency, shorter period of Tai Chi|12 weeks of supervised Tai Chi classes, 2x/week
16196775|NCT01420640|Behavioral|Shorter frequency, longer period of Tai Chi|24 weeks of supervised Tai Chi classes, 1x/week
16196776|NCT01420640|Behavioral|Higher frequency, longer period of Tai Chi|24 weeks of supervised Tai Chi classes, 2x/week
16199528|NCT01398449|Other|Adjuvant chemotherapy only|
16196777|NCT01420640|Behavioral|Aerobic Exercise Training|24 weeks of supervised aerobic exercise training, 2x/week
16196778|NCT01420627|Biological|EZN-2279|Weekly administration of EZN-2279 via IM injection
16196779|NCT01420627|Biological|Adagen|
16196780|NCT01420614|Procedure|Femoral approach|diagnostic and interventional procedures by femoral artery access
16196781|NCT01420614|Procedure|Radial approach|diagnostic and interventional procedures by radial artery access
16196782|NCT01420575|Behavioral|Visual Decision Aid and Shared Decision Making Model|Visual aid is a graph showing the average weight of patients who take olanzapine versus perphenazine over the course of 18 months. A script explaining the information on the graph, accompanies the graph. Patient may decide to stay on current dose of olanzapine, or be tapered off and prescribed a dose of perphenazine based on current symptoms and tolerability. Perphenazine (4-8mg ORALLY 3 times a day) will be used.
16196783|NCT01420575|Behavioral|Usual Care|Usual care is standard clinical discussion and advice from a psychiatrist. Patient may decide to stay on current dose of olanzapine, or be tapered off and prescribed a dose of perphenazine based on current symptoms and tolerability. Perphenazine (4-8mg ORALLY 3 times a day) will be used.
16196784|NCT01420562|Procedure|blood sampling|During posaconazole treatment, blood sampling will occur on day 0 (=day of transplantation), day 7 and 14 to correlate posaconazole exposure to severity of mucositis.
16196785|NCT01420549|Drug|Rosuvastatin 10 mg + Ezetimibe 10 mg and Rosuvastatin 20 mg + Ezetimibe 10 mg, according to clinical evaluation.|Tables containing: Rosuvastatin 10 mg + Ezetimibe 10 mg and Rosuvastatin 20 mg + Ezetimibe 10 mg, according to clinical evaluation.
16196786|NCT01420549|Drug|Simvastatin 20 mg + Ezetimibe 10 mg and Simvastatin 40 mg + Ezetimibe 10 mg, according to clinical evaluation.|Tables containing: Simvastatin 20 mg + Ezetimibe 10 mg and Simvastatin 40 mg + Ezetimibe 10 mg, according to clinical evaluation.
16196787|NCT01420536|Procedure|Occlusal scheme|"Before enrollment, all participants will receive conventional complete dentures adjusted according to the bilateral balanced occlusion concept.
~Following randomization, canine guidance will be achieved by adding composite resin (Restorative Z100, 3M Brazil, Sumaré, SP, Brazil) on the lingual surface of the maxillary canines. A sham comparator will also employ the addition of composite, but without changing eccentric contacts."
16196788|NCT01420523|Drug|Raltegravir-Maraviroc|Raltegravir 400 mg twice a day + Maraviroc 300 mg twice a day
16196789|NCT01420510|Drug|Adelmidrol vaginal gel|Application of a Adelmidrol vaginal gel
16196790|NCT01420510|Drug|Placebo vaginal gel|Application of a placebo vaginal gel
16196791|NCT01420497|Drug|intra-articular infiltration|intra articular infiltration
16196792|NCT01420497|Drug|epidural infiltration|epidural infiltration
16196793|NCT01420484|Other|different blood pressure intervals|In differnent blood presure intervals the IAP and CNAP measurement differences will be observed.
16196794|NCT01420471|Drug|Triamcinolone|Spacer will be impregnated with 2mL of Triamcinolone. The triamcinolone-impregnated spacer will be inserted into the middle meatal space after surgery. The spacer will be left in the middle meatus for a period of 6 days following surgery.
16196795|NCT01420471|Other|Saline-impregnated spacer|Spacer will be impregnated with 2mL of Saline solution. The saline-impregnated spacer will be inserted into the middle meatal space intraoperatively. The spacer will be left in the middle meatus for a period of 6 days following surgery.
16196796|NCT01420458|Drug|Experimental|Bioequivalence of two drug formulations
16196797|NCT01420445|Drug|YHD001 dose level 1|three times daily / 7 days
16196798|NCT01420445|Drug|YHD001 dose level 2|three times daily / 7 days
16196799|NCT01420445|Drug|Pelargonium sidoides extract|6-9mL three times daily / 7 days
16196800|NCT01420445|Drug|placebo|three times daily / 7 days
16196801|NCT01420432|Biological|Human umbilical cord-derived MSCs|1.0E+6 MSC/kg, IV drop and repeat repeated after three months
16196802|NCT01420419|Other|Lanolin|Pea-sized amount of lanolin applied to each nipple after every breastfeeding session (approximately 8-12 times daily) until complete resolution of nipple pain and damage for a maximum of 7 days.
16196803|NCT01420419|Other|Standard (usual) in-hospital and community postpartum care|Women randomized to standard care will not receive lanolin or information regarding how to use lanolin. In-hospital standard care may include any of the following pain management measures at the recommendation / discretion of the participant's health care provider, or based on the patient's personal preference: analgesics (such as ibuprofen or acetaminophen); application of cold or warm compresses; application of ice packs; use of breast shields; air drying the nipples; or applying expressed breast milk.
16196804|NCT01420406|Other|0 mg retinol activity equivalents|0 mg retinol activity equivalents (RAE) as white-fleshed sweet potatoes and a corn oil capsule
16196805|NCT01420406|Other|12 mg of BC|12 mg of BC as orange-fleshed sweet potatoes and a corn oil capsule
16196806|NCT01420406|Other|6 mg of CX|6 mg of CX as tangerines and a corn oil capsule
16196807|NCT01420406|Other|1.0 mg RAE|1.0 mg RAE vitamin A as retinyl palmitate in corn oil, and white-fleshed sweet potatoes
16196810|NCT01420367|Drug|metronidazole and cephalzolin|IV doses of metronidazole (12.5mg/kg up to 500mg) and cefazolin (25mg/kg up to 1g). One dose for study arm, two for comparative arm.
16196811|NCT01420341|Drug|Co-trimoxazole 12|Receive treatment with co-trimoxazole for 12 weeks.
16196812|NCT01420341|Drug|Co-trimoxazole 20|Receive treatment with co-trimoxazole for 20 weeks.
16196813|NCT01420328|Drug|Vytorin|Simvastatin 40 mg and Ezetimibe 10 mg daily combination pill (Vytorin
16196814|NCT01420302|Procedure|Nurse directed insulin titration|Nurse directed insulin titration to establish glycemic control in the target range of 80-110 mg/dL
16196815|NCT01420302|Procedure|LOGIC-Insulin|Blood glucose control (80-110 mg/dL) guided by the LOGIC-Insulin algorithm
16196816|NCT01420289|Device|High pressure intermittent pneumatic compression (HPIPC)|Apply therapy for 45 minutes twice daily
16196817|NCT01420289|Behavioral|Excercise|Treadmill walking 45 minutes once daily
16196818|NCT01420263|Procedure|Re-feeding residuals|In the presence of significant gastric residuals (more than 1/3 of previous feed or > 2ml), residual volumes will be re-fed if the physician decision is to continue feeds as scheduled in the absence of other clinical signs and symptoms of feeding intolerance. This practice will be continued until full enteral feeding is achieved and maintained for a minimum of 48 hours.
16196819|NCT01420263|Procedure|Fresh Feeding Breastmilk or Formula only|In the presence of significant gastric residuals (more than 1/3 of previous feed or > 2ml), residual volumes will be discarded and fresh breastmilk or formula will be fed if the physician decision is to continue feeds as scheduled in the absence of other clinical signs and symptoms of feeding intolerance. This practice will be continued until full enteral feeding is achieved and maintained for a minimum of 48 hours.
16196820|NCT01420250|Drug|Cabazitaxel|"Administered weekly on the same day of radiation according to the following infusion levels:
~Level 1 (Initial): 4 mg/m2; Level -1: 2 mg/m2; Level 2: 6 mg/m2; Level 3: 8 mg/m2; Level 4: 10 mg/2;"
16196821|NCT01420250|Radiation|Intensity Modulated Radiation Therapy (IMRT)|Starts 8 weeks after initiation of androgen deprivation therapy, given daily at 1.8 Gy for a total of 75.6 Gy
16196822|NCT01420250|Drug|Anti-Androgen Therapy: Bicalutamide|"Taken once daily by mouth starting between 2 weeks and 1 day before the first administration of Luteinizing Hormone-Releasing Hormone (LHRH)
~Will continue once daily until the final day of IMRT"
16196823|NCT01420250|Genetic|Luteinizing Hormone-Releasing Hormone (LHRH) Agonist|"First administration will occur 1 day to 2 weeks after the start of Bicalutamide and 8 weeks prior to the start of IMRT (+/- 4 weeks)
~Will continue for 24 months after IMRT
~Total administered duration and agent used must be documented on the case report form"
16196825|NCT01420224|Other|Commercial airline flight|Normal scheduled passenger flight
16196826|NCT01420211|Drug|Primovist® 0,25 mmol/ml solution for injection|intravenous bolus injection of 25 µmol/kg (=0,1 ml/kg) body weight Primovist® and blood sampling before (serum blank) and 6, 11, 21, 31, 45, 65, 95, 125 min and 3, 4, 6, 8, 12, 24 and 48 h after drug administration
16196827|NCT01420211|Device|MRI|lmaging of 20 slices (thickness: 3 mm; max. time of imaging 10 s) before and 0.25, 1, 2, 3, 4, 5, 7, 8, 9, 10, 20, 30, 40, 50, 60, 90 and 120 min after intravenous bolus injection of 25 µmol/kg (=0,1 ml/kg) body weight Primovist®
16196828|NCT01420198|Behavioral|Lifestyle intervention|Increased physical activity and improved food habits
16196829|NCT01420185|Genetic|RNA analysis|
16196830|NCT01420185|Genetic|gene expression analysis|
16196831|NCT01420185|Genetic|microarray analysis|
16196832|NCT01420185|Genetic|reverse transcriptase-polymerase chain reaction|
16196833|NCT01420185|Other|laboratory biomarker analysis|
16196834|NCT01420172|Other|Data Collection|Collection of data on patients who were seen at OSUMC at any time between 01Jan2000 and 30Jun2011 post hematopoietic stem cell transplantation
16196835|NCT01420159|Drug|Methoxyflurane|Patients will have access to two 3 mL methoxyflurane (Penthrox) Inhalers or two 5mL placebo Inhalers to be self-administered.
16196836|NCT01420146|Drug|Zr89-trastuzumab|trastuzumab labelled with zirconium 89 for PET/CT
16196837|NCT01420133|Other|Regimen|regimen normal in salt and sugar
16196838|NCT01420133|Other|Standard regimen|with diet low in salt and sugar
16196839|NCT01420094|Drug|Acetylsalicyclic acid (Fast release Aspirin, BAY1019036)|Single oral dose of fast release aspirin tablet 1000 mg (2 x 500 mg) and 2 placebo-matching acetaminophen caplets with a full glass of water (240 milliliter [mL]) between 1-4 hours post dental surgery.
16196840|NCT01420094|Drug|Acetaminophen (Tylenol extra strength)|Single oral dose of acetaminophen (Tylenol extra strength) caplet 1000 mg (2 x 500 mg) and 2 placebo matching aspirin tablets with a full glass of water (240 mL) between 1-4 hours post dental surgery.
16196841|NCT01420094|Drug|Placebo|Single oral dose of placebo (2 placebo aspirin tablets and 2 placebo acetaminophen caplets) with a full glass of water (240 mL) between 1-4 hours post dental surgery.
16196842|NCT01420081|Drug|PF-05212384|154mg IV weekly
16196843|NCT01420081|Drug|PF-05212384|154mg IV weekly
16196844|NCT01420081|Drug|PF-05212384|154mg IV weekly
16196845|NCT01420068|Drug|SPP100|
16196846|NCT01420055|Drug|fingolimod|
16196847|NCT01420042|Drug|NNZ-2566|Glycyl-L-2-Methylprolyl-L-Glutamic Acid (NNZ-2566) supplied as a lyophilized powder (2g in 50mL vials) for reconstitution with lemon flavoured cordial and Water for Injection.
16196848|NCT01420042|Drug|Placebo|Lemon flavoured cordial and Water for Injection
16196849|NCT01420016|Other|Prioritized Clinical Decision Support|Eighteen primary care clinics were blocked on size and on patient characteristics. Each clinic was randomly assigned to one of 2 study arms. All consenting PCPs were allocated to the study arm that their clinic was assigned to and the estimated 400 eligible adults with 10-year CVR >= 10% under the care of each consenting physician were allocated to the same treatment arm as their PCP.
16196850|NCT01420003|Procedure|Bone Marrow Aspiration|3 per study
16196851|NCT01420003|Procedure|Tonsil Biopsy|Optional upon completion of study
16196852|NCT01419990|Drug|GLPG0634|GLPG0634 300 mg oral capsules, qd, 10 days
16196853|NCT01419990|Drug|GLPG0634|GLPG0634 450 mg oral capsules, qd, 10 days
16196854|NCT01419990|Drug|Placebo|Placebo oral capsules, qd, 10 days
16196855|NCT01419977|Drug|Placebo|Normal saline solution, administered by nursing staff once daily
16196856|NCT01419977|Drug|Dalteparin|Low molecular weight heparin (LMWH), 5000 unites subcutaneously, administered by nursing staff once daily, Other Name: Fragmin
16196857|NCT01419964|Drug|Group 01|ACH24
16196858|NCT01419964|Drug|Group 02|Placebo
16196859|NCT01419951|Behavioral|Clinic + Home Behavioral Intervention|A 6 month intervention consisting of two phases: Phase I Intensive intervention is 12 weekly sessions that alternate between a group-based clinic session (concurrent parent and child groups) and individual home visits. Phase II Maintenance is 12 weeks of every other week visits alternating between clinic and home. Treatment targets 3 components: Dietary education, physical activity and parenting training.
16196860|NCT01419951|Other|Pediatrician Counseling|A one-time 45 minute visit with a board certified pediatrician that focuses on the AAP guidelines for eating and physical activity for preschool aged children.
16197161|NCT01417312|Dietary Supplement|Placebo|Daily intake of placebo capsules for 3 months
16196861|NCT01419951|Behavioral|Clinic Only Behavioral Intervention|A 6 month intervention consisting of two phases: Phase I Intensive intervention is 6 sessions delivered in a group-based format in clinic (concurrent parent and child groups) every other week. Phase II Maintenance is 3 monthly clinic visits. Treatment targets 3 components: Dietary education, physical activity and parenting training.
16196862|NCT01419938|Device|Light therapy and Cognitive behaviour therapy|Light therapy every morning during 30 minutes for two weeks. CBT for 90 to 120 minutes weekly during four weeks.
16196863|NCT01419938|Device|Light therapy|Light therapy every morning during 30-45 minutes for two weeks.
16196864|NCT01419925|Biological|Two Multimeric-001 administrations followed by TIV|Two administrations of non adjuvanted M-001, 500 mcg followed by TIV at intervals of 19-23 days
16196865|NCT01419925|Biological|One administration of Multimeric-001 followed by TIV|One administration of non adjuvanted Multimeric-001, 500 mcg, followed by TIV at intervals of 19-23 days
16196866|NCT01419925|Biological|One administration of adjuvanted M-001 followed by TIV|One administration of adjuvanted (Aluminum phosphate) Multimeric-001, 500 mcg, followed by TIV at intervals of 19-23 days
16196867|NCT01419925|Biological|One administration of placebo followed by TIV|One administration of saline (Placebo)followed by TIV at intervals of 19-23 days (serving as an active comparator)
16196868|NCT01419912|Dietary Supplement|soy milk|
16196869|NCT01419912|Dietary Supplement|cow's milk|
16196870|NCT01419899|Behavioral|Brief motivational intervention|A 20-30 minute motivational based discussion
16196871|NCT01419873|Drug|Actrapid Human Insulin|Actrapid Insulin is a drug used in routine neonatal practice to treat hyperglycaemia. The intervention in this study was to base dosing on insulin by a computer based-model approach as opposed to sliding scales, fixed protocols or clinician intuition
16196872|NCT01419860|Procedure|Elective colon resection|In our scientific experiment, we evaluate microcirculation in colon wall and anastomosis with laser induced fluorescence videoangiography of ICG. By implementing this technique we can measure average pixel intensity of fluorescence signal in area of interest on bowel, which represents tissue perfusion in this respective part of intestinal wall.
16196873|NCT01419847|Drug|Ciclopirox|
16196874|NCT01419847|Drug|Placebo|
16196875|NCT01419834|Biological|Humanized 3F8 Monoclonal Antibody (Hu3F8)|Hu3F8 is infused IV over ~30 minutes
16196876|NCT01419821|Drug|Vitamin D|800IU (4gtt/d) once a day for 2 years once a day.
16196877|NCT01419821|Other|Placebo (for Vitamin D)|4gtt/d for the placebo for two years.
16196878|NCT01419808|Procedure|Vascularized Bone Graft|Vascularized bone graft in the treatment of Scaphoid Non-Union
16196879|NCT01419808|Procedure|Non-Vascularized Bone Graft|Non-Vascularized Bone Graft in the treatment of Scaphoid Non-unions
16196880|NCT01419795|Drug|lenalidomide|Given PO
16196881|NCT01419795|Biological|rituximab|Given IV
16196882|NCT01419795|Other|pharmacological study|Correlative studies
16196883|NCT01419795|Other|laboratory biomarker analysis|Correlative studies
16196884|NCT01419782|Other|Whole-body vibration|Frequency: 40 Hz, vibration amplitude: 2 mm, duration: 60 sec
16196885|NCT01419769|Device|AXIOS Stent & Delivery System|"The AXIOS Stent & Delivery System study is a prospective, multi-center, non-blinded, single-arm(nonrandomized) study that will be conducted at up to 10 sites in the United States, European Community and/or Japan will enroll a total of 24 patients. A majority of the patients will be enrolled in the United States.
~Patients between the age of 18 and 75 scheduled for endoscopic drainage of symptomatic pancreatic pseudocysts that are equal or greater than 6 cm in diameter, adherent to the bowel wall, and have ≥ 70% fluid contents are potential study candidates.
~Study patients will undergo the following clinical follow-up evaluations of study endpoints conducted at 30 days, 60 days, 1 week post stent removal and possibly at 3 and 6 months post stent removal."
16196886|NCT01419756|Device|VentriPoint Medical System|The Knowledge Based Reconstruction (KBR) method generates a 3D reconstruction of the RV based on the Piecwise smooth subdivision surface method but without requiring manual border tracing. Instead KBR reconstructs a new patient's ventricular surface from the placement of anatomic landmark points on a 2D ultrasound image
16196887|NCT01419730|Drug|Vitamin D3|Vitamin D3 50,000 IU
16196888|NCT01419730|Behavioral|Physical Activity|Progressive walking and resistance band exercise prescription for a period of 24 weeks
16196889|NCT01419717|Drug|Denosumab|Administered by subcutaneous injection every 4 weeks (Q4W)
16196890|NCT01419704|Biological|Enriched Hematopoetic Stem Cell Infusion|Enriched Hematopoetic Stem Cell Infusion
16196891|NCT01419691|Drug|auranofin|6 mg twice a day for a total of 12 mg total daily dose
16196892|NCT01419678|Other|collection of blood samples for PK testing|PK samples collected around dosing of posaconazole
16196893|NCT01419665|Biological|GP2013|Type: Biological/Vaccine
16196894|NCT01419665|Biological|rituximab|Type: Biological/Vaccine
16196895|NCT01419652|Other|hold hypoglycemic meds|continue versus hold hypoglycemic medications
16196896|NCT01419639|Drug|Everolimus (RAD001) , Afinitor®|Everolimus will be provided by Novartis. Everolimus is formulated as tablets for oral administration of 2.5 mg, 5 mg, 10 mg strength. Everolimus will be self-administered (by the patients themselves) or administered by the patient's parent or guardian (for minors). The investigator will instruct the patient to take the study drug exactly as specified in the protocol. Depending the age-based dosing schedule, everolimus should be administered orally once (or twice) daily, preferably in the morning (and evening), at the same time every day with our without food. Everolimus tablets should be swallowed whole with a glass of water. The tablets must not be chewed or crushed. In cases where tablets can not be swallowed, the tablets should be disintegrated in water just prior to being taken. Everolimus will be administered orally as per the age-based dosing schedule continuously from study day 1 until progression of disease or unacceptable toxicity.
16196897|NCT01419626|Device|Interdental cleaning device with water|Subjects will be instructed to follow their usual oral hygiene habits with the provided toothbrush and toothpaste, and to use their assigned product once a day for a period of 4 weeks.
16196898|NCT01419626|Device|Interdental cleaning device with essential-oil mouthrinse|Subjects will be instructed to follow their usual oral hygiene habits with the provided toothbrush and toothpaste, and to use their assigned product once a day for a period of 4 weeks.
16196899|NCT01419613|Behavioral|Motivational Interviewing|Breast cancer survivors will receive general information on how to adopt healthy lifestyle behaviors.
16196900|NCT01419613|Behavioral|Counseling|The control group of breast cancer survivors will receive counseling on how to increase their level of physical activity.
16196901|NCT01419600|Drug|AZD8683|Single Dose Inhaled IMP via Turbuhaler
16196902|NCT01419600|Drug|Placebo to match|Single dose Inhaled Placebo via Turbuhaler
16196903|NCT01419587|Dietary Supplement|Ketogenic diet|A ketogenic diet matching the fat to carbohydrate + proteins in Keto-Cal(R) 4:1 by Nutricia North America.
16196904|NCT01419561|Drug|Zidovudine|Zidovudine 600 mg will be administered orally 4 times a day or i.v. at 300 mg every 6 hours for 14 days for cycle 1 and for 7 days (up to additional 7 days if ongoing symptoms) for following cycles.
16196905|NCT01419561|Drug|Liposomal Doxorubicin|Liposomal doxorubicin (20 mg/m2) will be administered i.v. over 1 hour at day 1 of each cycle
16196906|NCT01419561|Drug|Valganiclovir|Valganciclovir (900mg) will be administered orally twice/day or Ganciclovir (5 mg/kg) will be administered i.v. over 1 hour for 14 days for cycle 1 and for 7 days (up to additional 7 days if ongoing symptoms) for following cycles.
16196907|NCT01419561|Drug|Rituximab|"Rituximab (375 mg/m2) will be admnistered i.v. at 50 mg/hr up to 100 mg/hr at day 1 of the first cycle and at 100mg/hr up to 400 mg
~/hr at day 1 of following cycles."
16196908|NCT01419561|Other|Standard Therapies|Standard of Care drugs
16196909|NCT01419548|Drug|ABT-888|
16196910|NCT01419548|Drug|Carboplatin|
16196911|NCT01419548|Drug|Paclitaxel|
16196912|NCT01419535|Drug|Mifepristone|Mifepristone 50mg tablet by mouth every six hours for nine days.
16196913|NCT01419535|Drug|Placebo|Placebo (matching mifepristone 50mg tablet) by mouth every six hours for nine days.
16196914|NCT01419522|Other|Gait Training Method|Treadmill training at constant velocity
16196915|NCT01419509|Genetic|DNA methylation analysis|
16196916|NCT01419509|Genetic|microarray analysis|
16196917|NCT01419509|Genetic|polymerase chain reaction|
16196918|NCT01419509|Other|laboratory biomarker analysis|
16196919|NCT01419496|Genetic|protein expression analysis|
16196920|NCT01419496|Other|flow cytometry|
16196921|NCT01419496|Other|laboratory biomarker analysis|
16196922|NCT01419483|Dietary Supplement|Ketogenic diet|A ketogenic diet matching the fat to carbohydrate + proteins in Keto-Cal(R) 4:1 by Nutricia North America.
16196923|NCT01419470|Drug|dapoxetine|"multiple dosing
~12 subjects will be administered YHD1044 (I, III, V) or active/placebo comparators;dapoxetine"
16196924|NCT01419457|Drug|Favipiravir|1200 mg BID for Day 1 + 800 mg BID for Day 2-5
16196925|NCT01419457|Drug|Favipiravir|800 mg BID for Day 1 + 400 mg BID for Day 2-3
16196926|NCT01419457|Drug|Favipiravir|800 mg Single Dose
16196927|NCT01419444|Behavioral|Airflow Exercises for Voicing|Gargling, Cup Bubble Blowing, and Stretch and Flow Exercises will be taught to reduce laryngeal closure and improve airflow through the glottis during voicing.
16196928|NCT01419431|Procedure|Laparoscopic resection|Inflammatory response in laparoscopic surgery
16196929|NCT01419405|Drug|Pregabalin|hard capsule, 150 mg, 2 times, 2 days
16196930|NCT01419405|Drug|Remifentanil|50-90 min: TCI 0.6 ng/mL, 100-140 min: 1.2 ng/mL, 150-190 min: TCI 2.4 ng/mL
16196931|NCT01419405|Drug|sugar pill, saline infusion|hard capsule, 150 mg, 2 times, 2 days, saline infusion
16196932|NCT01419392|Drug|Sildenafil citrate|25 mg orally, 4 times per day for 21 days
16196933|NCT01419392|Drug|matching placebo|orally, 4 times per day for 21 days
16196934|NCT01419366|Drug|Torrent's Donepezil Hydrochloride Tablets 10mg|
16196935|NCT01419353|Drug|estradiol valerate|2 mg P.O / day for 1-6 days.
16196936|NCT01419340|Drug|Torrent's Donepezil Hydrochloride Tablets 10mg|
16196937|NCT01419327|Drug|Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet|Patients in hemodialysis who have received Fosrenol for hyperphosphatemia.
16196938|NCT01419314|Device|Splinting application to the lower extremities|Walkabout™ splints (Don Joy Orthopedics, Vista, CA, USA) will used in the splinting treatment. The Walkabout splint is a one-piece injection molded walking boot fitted with a rocker bottom allowing for ambulation. The participants will be fitted and instructed to wear the bilateral LE splints to sleep for the duration of the study (6 weeks).
16196939|NCT01419314|Device|Splint liner application|The liner or protective sheath from the Walkabout™ splint will be applied to the LEs, with the structural frame of the splint removed by the researcher in advance, patients will be blinded to this arm of the study (6 weeks).
16196940|NCT01419301|Behavioral|Mindfulness based stress reduction (MBSR)|Mindfulness based stress reduction (MBSR) is program based on daily meditation practice that guides an individual towards increased awareness and self-regulation of thoughts and actions. MBSR is easier to implement and may be shown to be more effective than cognitive-behavioral stress reduction, and is more applicable to patients with chronic illness.
16196941|NCT01419288|Other|Treadmill Training|The program requires volunteer participants to attend 15 sessions over 10 to 12 weeks with a total time commitment of 13.5 hours. There is an initial testing session that includes an assessment of the participant's legs, balance, and walking abilities. The entire program includes 12 treadmill training visits that take place three times per week for four weeks, a post-training testing session one week after completion of the training, and a follow-up testing session four weeks after completion of the training.
16196942|NCT01419275|Drug|Xenon contrast agent|
16196943|NCT01419275|Device|Magnetic Resonance Imaging|Arterial spin label sequence for the purpose of measuring collateral flow
16196944|NCT01419262|Drug|Vitamin D - Cholecalciferol 400 IU|One drop per day (liquid), 400 IU, 4 to 9 months depending on date of enrollment and date of follow-up
16196945|NCT01419262|Drug|Vitamin D3 - Cholecalciferol 2000 IU|One drop per day (liquid), 2000 IU, 4 to 9 months depending on date of enrollment and date of follow-up
16196946|NCT01419249|Other|Blood sampling|Subjects with pre-established diagnosis of IGHD and TS and were treated with r-hGH therapy for 1 year, will be observed in this retrospective cohort study wherein blood sampling will performed for genotyping of the various genetic markers along with collection of retrospective data relative to the r-hGH treatment.
16196947|NCT01419236|Drug|Testosterone Solution 2%|Administered topically
16196948|NCT01419236|Drug|Placebo Solution|Administered topically
16196949|NCT01419210|Other|Pre-study Questionnaire|Assess the interest level for various CAM topics through feedback received from the study participants
16196951|NCT01419210|Other|CAM Therapies|Integrate the CAM topics of highest interest into participant's regular care
16196952|NCT01419210|Other|Post-study Questionnaire|Examine the data to see if it supports recommending a larger, multi-site, integrative CAM program for other women with ovarian cancer
16196953|NCT01419197|Drug|Trastuzumab emtansine|The dose was calculated based on the patient's Baseline weight on Day 1 of each 3-week treatment cycle. The same dose was administered in subsequent cycles if the patient's weight stayed within 10% of the Baseline weight. If there was a weight change > 10%, the dose was adjusted accordingly and the recorded weight became the new Baseline weight. Trastuzumab emtansine was provided as a single-use lyophilized formulation.
16196954|NCT01419197|Drug|Treatment of physician's choice|"The treatment of physician's choice (TPC) was a protocol-specified approved or standard of care therapy or combination of therapies, based on frequently used regimens for late-line HER2-positive metastatic breast cancer treatment after receipt of both trastuzumab- and lapatinib-containing regimens. The therapies included single-agent chemotherapy, single-agent (e.g., tamoxifen or aromatase inhibitor) or dual-agent (e.g., aromatase inhibitor with luteinizing hormone releasing hormone [LHRH] agonist) hormonal therapy for hormone receptor positive-disease, and HER2-directed therapy.
~Participants who had documented progressive disease (PD) were eligible to switch treatment to receive trastuzumab emtansine 3.6 mg/kg. Participants who switched treatment remained on trastuzumab emtansine treatment until another PD event or unmanageable toxicity.
~The formulation, storage, and preparation of all TPC were as per the appropriate package insert or national prescribing information."
16196955|NCT01419184|Drug|Daptomycin|
16196956|NCT01419184|Drug|Vancomycin|
16196957|NCT01419171|Device|OMEGA™ Monorail Coronary Stent System|All enrolled patients are treated with the OMEGA™ Monorail Bare Metal Coronary Stent System and followed for 12 months post-procedure.
16196958|NCT01419145|Other|Multimodal intervention|Nutritional supplements aimed at optimal energy balance and protein intake (2 cartons of ProSure per day), nutritional advice, home-based self-assisted exercise program and anti-inflammatory treatment (300 mg celecoxib) for 6 weeks. The aerobic exercise program is performed as self-administered daily walking sessions, aiming for a minimum of two sessions 30 minutes on a weekly basis. Other aerobic activities could be used instead of walking. The resistance exercise program should be performed 3 times weekly and lasts about 20 minutes. The program is targeting major muscle groups in the upper body and legs with use of weights. The intensity of the exercise and performance of the exercises are adapted to the individual patient's disease burden and physical performance.
16196959|NCT01419145|Other|Standard care|Standard cancer care
16196960|NCT01419132|Drug|Furosemide|125-250 mg furosemide bid
16196961|NCT01419132|Drug|Furosemide|125-250 mf furosemide bid
16196962|NCT01419119|Drug|Cholecalciferol|10 000 IU daily i.e. 15 drops orally once daily for 12 weeks
16196963|NCT01419119|Drug|Cholecalciferol|2000 IU daily i.e. 3 drops orally once a day for 12 weeks,
16196964|NCT01419119|Drug|Cholecalciferol|2000 IU once a week i.e. 3 drops orally once a week (the same day every week) for 12 weeks,
16196965|NCT01419119|Drug|Cholecalciferol|2000 IU daily i.e. 3 drops orally once daily for 12 weeks
16196966|NCT01419106|Device|Ultrasound (A point of care ultrasound protocol)|Bedside ultrasound will be used to view any intraperitoneal bleeding, pleural fluid, cardiac abnormalities, or structural abnormalities of major blood vessels. The results of this test will then be used to determine the best course of treatment for the patient.
16196967|NCT01419093|Other|5 A communication intervention|This study will examine the effect of primary care clinicians' communication intervention linked to a community-based exercise program. We will use the 5As in discussion of physical activity in 371 office visits in an ethnically diverse, primarily low income patient population. Secondary and exploratory aims are to provide pilot information on [feasibility and sustainability of the intervention from the patients' and clinicians' perspective and derive effect sizes on the intervention's effect on objective changes in physical activity in a subset of participants.
16196968|NCT01419067|Procedure|Radical Surgery or Limited Surgery|Patients will be selected for radical surgery based on the neurosurgeon's assessment that a Gross-Total Resection may be achieved with acceptable post-operative morbidity. The goal of surgical intervention in this study should be to facilitate tumor control, keeping surgical morbidity to a minimum. Common indications for surgical intervention directed at the tumor will include establishing a tissue diagnosis, tumor control by radical resection, relieving tumor mass effect to reduce symptoms and decreasing the target volume for proton therapy by planned volume reduction surgery. These indications can be achieved through radical or limited surgery.
16196969|NCT01419067|Device|Proton Therapy|Proton therapy will be started once a final treatment plan has been developed and approved. There is no time limit for the interval from enrollment to when proton therapy commences. The total prescribed dose will be 54CGE administered at 1.8CGE per fraction. The time course of administration will be one fraction per day, 5 days per week, for a period of 6 weeks. Radiation will be prescribed to the planning target volume which will include the tumor bed encompassed by an anatomically defined margin meant to include subclinical microscopic disease, and an additional geometric margin that is meant to account for the technical limitations associated with planning and administering daily fractionated treatment. Making radiation therapy safer through the use of proton therapy.
16196970|NCT01419067|Drug|^1^8F-fluorodeoxyglucose|This is a contrast media that will be given intravenously to aid in tumor visualization.
16196971|NCT01419067|Drug|^1^1C-methionine|This is a contrast media that will be given intravenously to aid in tumor visualization.
16196972|NCT01419041|Drug|crizotinib|Single-dose oral 250 mg crizotinib in subjects with normal renal function (CLcr =>90 mL/min)
16196973|NCT01419041|Drug|crizotinib|Single-dose oral 250 mg crizotinib in subjects with severe renal impairment (CLcr <30 mL/min)
16196974|NCT01419015|Device|SAPIEN XT NovaFlex delivery system|Transcatheter aortic valve implantation via transfemoral approach.
16196975|NCT01419002|Radiation|neoadjuvant RTx|Neoadjuvant radiotherapy with external intensity modulated beam radiation followed by duodenopancreatectomy and adjuvant chemotherapy according to German S3 guidelines.
16196976|NCT01419002|Procedure|Surgery|Surgery and adjuvant chemotherapy according to German S3-guidelines
16196977|NCT01418989|Drug|tocilizumab [RoActemra/Actemra] Syringe|Single dose administration with pre-filled syringe
16196978|NCT01418989|Drug|tocilizumab [RoActemra/Actemra] auto-injector|Single dose administration with auto-injector
16196979|NCT01418976|Behavioral|Intensive Mobility Training (IMT)|Intensive Mobility Training will be used as an intensive physical therapy intervention. Participants will receive 3 hours per day for a 10 day session, be post-tested, and receive another 10 day session followed by two more testing sessions.
16196980|NCT01418963|Drug|RO5285119|single and multiple ascending oral doses
16196981|NCT01418963|Drug|placebo|single and multiple oral doses
16196982|NCT01418950|Other|Written information and verbal counseling|control group will only receive verbal counseling. Study group will receive written information before verbal counseling
16196983|NCT01418937|Biological|CervarixTM (GSK580299)|Three intramuscular injections
16196984|NCT01418911|Other|questionnaire|questionnaire only
16196985|NCT01418898|Other|Dietary Intervention|Nutrient fortified oat beverage
16196986|NCT01418872|Other|Didactic Concerts|"The activity we are going to test consists in a communication and spreading strategy.
~The activity will take place in the auditorium of the school, scheduling 1 hour for concert, within the school hours, and having maximum 50 children per turn.
~Preparation of the auditorium for the activity 5 classic musical pieces and a story as a conducting thread. Children will be asked to clap and raise hands to participate in the mission of becoming a heart-savers: Ideal number of daily meals, Importance of daily breakfast for the activity, Time for breakfast, Basic components for a healthy breakfast, The role of cereals at breakfast, dairy products in breakfast, fruits at breakfast, Importance of exercise for cardiovascular health, The role of sedentary lifestyle.
~Students will be invited to take the playbill as a bookmark format and a cup is inscribed: I am a heart-saver, so that they take them home and serve as a reminder of the activity. A NAOS strategy pamphlet will also be delivered."
16196987|NCT01418820|Device|Verum stimulation|10 days (2x 5 working days), daily transorbital alternating current stimulation (rtACS) is applied with a device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse is below 1000 µA. Current intensity is individually adjusted according to how well patients perceived phosphenes, e.g. any sensation of flickering light in response to the rtACS stimulation. Stimulation frequencies were between the individual alpha frequency peak and below flicker fusion.
16196988|NCT01418820|Device|Placebo stimulation|10 days (2x 5 working days), daily sham-stimulation with the same electrode montage set-up that is used for verum transorbital alternating current stimulation (rtACS). Minimal sham-stimulation was performed with single bursts (approx. one per min) of electrical currents at a given frequency of 5Hz and individually adjusted current amplitude.
16196989|NCT01418807|Procedure|TRANSVAGINAL SPECIMEN EXTRACTION|Transvaginal specimen retrieval following posterior colpotomy
16196990|NCT01418807|Procedure|TRANSUMBILICAL SPECIMEN EXTRACTION|Transumbilical specimen retrieval following enlargement of the umbilical port
16196991|NCT01418794|Device|High dose rapamycin stent|Concentration of rapamycin is 2.5%
16196992|NCT01418794|Device|Low dose rapamycin stent|Concentration of rapamycin is 1.5%
16196993|NCT01418768|Other|inpatient rehabiliation|inpatient, multimodal, individual workout including endurance training, strength training, coordination training etc. for three weeks.
16196994|NCT01418755|Biological|platelet rich plasma injection|The approximate 2.0 to 2.5-fold platelet concentration (taking into consideration the mean human blood platelet count of 200 000 /μl) was achieved in all specimens. Mean platelet concentration in PRP was 459 000 /μl (range, 407 000 /μl to 513 000 /μl).
16196995|NCT01418742|Drug|Panitumumab, Doxycycline/Placebo|comparison of Doxycyline/Placebo and Panitumumab regarding efficacy of the therapy of panitumumab induced skin toxicity
16196996|NCT01418742|Drug|Panitumumab|mCRC patients receiving panitumumab as EGFR inhibitor.
16196997|NCT01418729|Drug|Pravastatin|"Treatment:
~Patients will be randomized in two groups, A and B:
~Control Group (A ≡ 1): Patients will receive treatment with sorafenib 400 mg/12 h + placebo/24 h.
~Experimental Group (B ≡ 2): The treatment received will be sorafenib 400 mg/12 h + pravastatin 40 mg/24 h."
16196998|NCT01418716|Other|Facilitation|Facilitation is a change management process. In the TRANSIT study, the change consist in implementing the TRANSIT program in primary care clinics. In the facilitation group, external facilitators accompany, support, and empower clinical teams so they quickly develop a sense of ownership regarding new clinical practices and sustainably implement them with lower costs. External facilitators offer counseling, coaching, and various tools to an internal facilitation team composed of clinicians of the clinical team to support their efforts in implementing change in their practices. Facilitation activities are structured in a cycle of 4 steps, the Plan-Do-Study-Act cycle (PDSA cycle).
16196999|NCT01418716|Other|Passive diffusion|Clinical teams in primary care clinics implement the TRANSIT program without the help of facilitators.
16197000|NCT01418703|Device|Closed Loop Control (CLC)|In this study, the researchers compared the management of diabetes during physical activity and meals with the closed-loop system developed at the University of Virginia. This Control to Range System uses two DexCom Seven Continuous Glucose Monitor, a computer containing an investigational control algorithm (well-defined instructions that are expressed in mathematical equations), and an OmniPod Insulin Management System, a portable subcutaneous (under the skin) insulin pump. During the closed-loop admission, the computer used CGM values to make recommendations of insulin treatment based on the algorithms.
16197001|NCT01418703|Device|Open Loop|This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Subjects use their own pump. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...).
16197002|NCT01418677|Drug|E7389|Severe renal impairment-the dose to be administered will be based on the interim analyses of safety and pharmacokinetics in subjects with moderate renal impairment (Cohort 1).
16197003|NCT01418677|Drug|E7389|Moderate renal impairment-HALAVEN will be dosed at 1.4 mg/m2.
16197004|NCT01418677|Drug|E7389|Normal renal function-HALAVEN will be dosed at 1.4 mg/m2.
16197005|NCT01418664|Dietary Supplement|D Max drops|Women in study arm will be cases, and will recieve ferrous sulphate and calcium lactate, along with 4000IU D Max drops
16197006|NCT01418651|Drug|Savella|milnacipran 25 to 200 mg daily, divided into two doses (morning and evening)
16197007|NCT01418625|Drug|Venlafaxine Hydrochloride Extended-Release Capsules 150mg (Test formulation, Torrent Pharmaceutical Limited., India)|
16197008|NCT01418612|Drug|Venlafaxine Hydrochloride Extended-Release Capsules of Torrent Pharmaceuticals Limited|
16197011|NCT01418573|Other|Palaeolithic meal 1|Based on estimated ratios for protein, fat and carbohydrates that are typical of Hunter-Gatherers and does not contain ingredients that were not available in pre-neolithic times
16197012|NCT01418573|Other|Palaeolithic meal 2|Based on WHO dietary guidelines for protein, fat and carbohydrate but does not contain ingredients that were not available in pre neolithic times
16197013|NCT01418573|Other|Reference meal|Based on WHO dietary guidelines for protein, fat and carbohydrate.
16197014|NCT01418560|Procedure|renal sympathetic modification|Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure
16197015|NCT01418547|Drug|Torrent's Isosorbide Mononitrate 120 mg ER Tablets|
16197016|NCT01418534|Drug|Torrent's Isosorbide Mononitrate 120 mg ER Tablets|
16197017|NCT01418521|Drug|Balanced hydroxyethyl starch solution|Patients receiving Tetraspan 6% ( a balanced 3rd generation Hydroxyethyl starch)for volume replacement after elective cardiac surgery as needed.
16197018|NCT01418521|Drug|Ringer- albumin|Patients receiving lactated ringer-albumin solution for volume replacement after cardiac surgery
16197019|NCT01418508|Behavioral|low protein diet plus α-keto acid|low protein diet plus α-keto acid 0.6g of proteins per kilo of body weight per day, supplemented with α-keto acid tablets
16197020|NCT01418508|Behavioral|very low protein diet plus α-keto acid|very low protein diet plus α-keto acid 0.3g of proteins per kilo of body weight per day, supplemented with α-keto acid tablets
16197021|NCT01418495|Other|Cytology Specimen Collection Procedure|Correlative studies
16197022|NCT01418495|Other|Pharmacological Study|Correlative studies
16197023|NCT01418482|Device|Mepilex Border Ag|a silver dressing
16197024|NCT01418469|Dietary Supplement|Caseinate|18 mg protein/kg body weight caseinate and 46 mg maltodextrin / kg body weight per 20 min sip feeding
16197025|NCT01418469|Dietary Supplement|Whey protein isolate|18 mg protein/kg body weight whey protein isolate and 46 mg maltodextrin / kg body weight per 20 min sip feeding
16197026|NCT01418469|Dietary Supplement|Soy|18 mg protein/kg body weight soy and 46 mg maltodextrin / kg body weight per 20 min sip feeding
16197027|NCT01418469|Dietary Supplement|soy+BCAA|18 mg protein/kg body weight soy+BCAA and 46 mg maltodextrin / kg body weight per 20 min sip feeding
16197028|NCT01418456|Drug|antibiotics|A variety of antibiotics may be used, according to microbiology results, for up to 20 weeks
16197029|NCT01418443|Drug|Torrent's Pantoprazole Sodium Delayed - Release Tablets|
16197030|NCT01418430|Drug|CHOP-daclizumab|
16197031|NCT01418417|Drug|Torrent's Pantoprazole Sodium Delayed - Release Tablets|
16197032|NCT01418404|Other|Noxious TS|hot, cold alternately, noxious TS in study A
16197033|NCT01418404|Other|Innocuous TS|warm, cool alternately, Innocuious TS in study A
16197034|NCT01418404|Other|High Frequency of Noxious TS|High Frequency of Noxious TS in study B
16197035|NCT01418404|Other|Low Frequency of Noxious TS|Low Frequency of Noxious TS in study B
16197036|NCT01418404|Other|High Intensity of Noxious TS|High Intensity of Noxious TS in study C
16197037|NCT01418404|Other|Low Intensity of Noxious TS|Low Intensity of Noxious TS in study C
16197038|NCT01418391|Procedure|Transversus Abdominis Plane block|"TAP BLOCK:
~dosage form: 0.5% bupivacaine 75mg with 2% xylocaine 300 mg mixed dosage: total 30 ml frequency: single shot duration: 12~18 hours upon to the regional anesthetics choose"
16197039|NCT01418378|Device|Sigma CR150|Sigma CR150 femoral component used in combination with the Highly Polished Cobalt Chrome fixed bearing tibial tray and the Curved (XLK) polyethylene bearing (cemented, no patellar resurfacing).
16197040|NCT01418378|Device|Sigma CR|Sigma CR femoral component used in combination with the Highly Polished Cobalt Chrome fixed bearing tibial tray and the Curved (XLK) polyethylene bearing (cemented, no patellar resurfacing).
16197041|NCT01418365|Drug|Metronidazole + MMX Mesalazine/mesalamine placebo|Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine placebo once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine placebo single dose on Day 4 orally
16197042|NCT01418365|Drug|Metronidazole + MMX Mesalazine/mesalamine|Metronidazole 750 mg twice daily + MMX Mesalazine/mesalamine 4.8 g once daily for 3 days orally, then Metronidazole 750 mg single dose + MMX Mesalazine/mesalamine 4.8 g single dose on Day 4 orally
16197043|NCT01418352|Drug|Aripiprazole|Aripiprazole tablets once weekly for 8 weeks.
16197044|NCT01418352|Drug|Placebo|Aripiprazole matching-placebo once-weekly for 8 weeks.
16197045|NCT01418339|Drug|Aripiprazole|Aripiprazole tablet administered orally once a week.
16197046|NCT01418339|Drug|Placebo|Aripiprazole-matching placebo tablet administered orally once a week.
16197047|NCT01418300|Drug|sequential versus triple|sequential: lansoprazole 30mg bid+amoxicillin 100mg bid for first five day lansoprazole 30mg bid+clarithromycin 500mg bid+metronidazole 500mg for 5day conventional tripe lansoprazole 30mg bid+clarithromycin 500mg bid+amoxicillin 1000mg bid
16197048|NCT01418274|Drug|danoprevir|oral doses of danoprevir
16197049|NCT01418274|Drug|escitalopram|oral doses of escitalopram
16197050|NCT01418274|Drug|ritonavir|oral doses of ritonavir
16197051|NCT01418261|Device|Renal denervation (Symplicity Catheter System)|
16197052|NCT01418261|Diagnostic Test|Renal angiogram|
16197053|NCT01418235|Biological|MVA-C + gp140/MF59|"SAAVI MVA-C administered as 0.5 ml intramuscularly in right deltoid, with placebo in left deltoid, at Month 0; SAAVI MVA-C administered as 0.5 ml intramuscularly in right deltoid at Month 1; Novartis subtype C gp140 admixed with Novartis MF59 adjuvant administered as 0.5 ml intramuscularly in left deltoid, with placebo in right deltoid, at Months 3, 6.
~Placebo comparator: Placebo administered at Months 0, 1, 3, 6"
16197054|NCT01418235|Biological|MVA-C + gp140/MF59|"SAAVI MVA-C administered as 0.5 ml intramuscularly in right deltoid, with Novartis subtype C gp140 admixed with Novartis MF59 adjuvant administered as 0.5 ml intramuscularly in left deltoid, at Months 0, 3; placebo in right deltoid at Month 1; placebo in each deltoid at Month 6
~Placebo comparator: Placebo administered at Months 0, 1, 3, 6"
16197055|NCT01418235|Biological|DNA-C2 + MVA-C|"SAAVI DNA-C2 administered as 1 ml intramuscularly in right deltoid, with placebo in left deltoid, at Month 0; SAAVI DNA-C2 administered as 1 ml intramuscularly in right deltoid at Month 1; SAAVI MVA-C administered as 0.5 ml intramuscularly in right deltoid, with placebo in left deltoid, at Months 3, 6
~Placebo comparator: Placebo administered at Months 0, 1, 3, 6"
16199577|NCT01398098|Drug|Sodium phosphate|32 tablets
16197056|NCT01418235|Biological|DNA-C2 + MVA-C + gp140/MF59|"SAAVI DNA-C2 administered as 1 ml intramuscularly in right deltoid, with placebo in left deltoid, at Month 0; SAAVI DNA-C2 administered as 1 ml intramuscularly in right deltoid at Month 1; SAAVI MVA-C administered as 0.5 ml intramuscularly in right deltoid at Months 3, 6; Novartis subtype C gp140 admixed with Novartis MF59 adjuvant administered as 0.5 ml intramuscularly in left deltoid, with placebo in right deltoid, at Months 3, 6
~Placebo comparator: Placebo administered at Months 0, 1, 3, 6"
16197057|NCT01418222|Drug|5-FU|Intravenous repeating dose
16197058|NCT01418222|Drug|FOLFOX regimen|Intravenous repeating dose
16197059|NCT01418222|Drug|Placebo|Intravenous repeating dose
16197060|NCT01418222|Drug|bevacizumab [Avastin]|Intravenous repeating dose
16197061|NCT01418222|Drug|leucovorin|Intravenous repeating dose
16197062|NCT01418222|Drug|onartuzumab [MetMAb]|Intravenous repeating dose
16197063|NCT01418209|Drug|Low-dose 17-ß-estradiol with progesterone taper|Low-dose 17-ß-estradiol oral (by mouth), 0.5 mg once per day for 8 (eight) weeks. 17-ß-estradiol is approved by the US Food and Drug Administration (FDA) and is indicated for the treatment of menopausal symptoms. ß is the Greek symbol for beta; the symbol and the word are used interchangeably. The 8 week estradiol treatment is followed by 14 days (2 weeks) of progesterone taper (as medroxy-progesterone 10 mg/day).
16197064|NCT01418209|Drug|Venlafaxine XR|Venlafaxine oral (by mouth) 37.5 mg once per day for 1 (one) week, then 75 mg once per day for 7 (seven) weeks. Venlafaxine XR should not be taken while also taking monoamine oxidase inhibitors (MAOIs). Venlafaxine XR is approved by the US Food and Drug Administration (FDA) for treatment of depression, generalized anxiety disorder, social anxiety disorder, and panic disorder, and is available by prescription. Venlafaxine XR is not FDA-approved for the treatment of hot flashes, although prior studies have indicated that it is useful for treating hot flashes and vasomotor symptoms. After the 8-week venlafaxine XR study treatment period, women will receive a tapering dose of venlafaxine XR 37.5 mg once per day for 14 days (2 weeks).
16197065|NCT01418209|Drug|Placebo|The placebo is an inactive pill that looks like the active medication.
16197066|NCT01418183|Procedure|Trigeminal nerve block|5ml of long-effective local analgesics (5% levobupivacaine) will be delivered to maxillary and mandibular branches of trigeminal nerve.
16197067|NCT01418183|Procedure|Trigeminal nerve block|2.5ml of long-effective local analgesics (5% levobupivacaine) will be delivered to maxillary and mandibular branches of trigeminal nerve.
16197068|NCT01418183|Procedure|Trigeminal nerve block|5ml Normal saline will be delivered to maxillary and mandibular branches of trigeminal nerve.
16197069|NCT01418170|Other|cervical spinal manipulative therapy|A real cervical spine manipulation will be used for the intervention vs a sham cervical spine manipulation. For the rcSMT the subject's head will be supported by the clinician's forearm. The contact hand of the clinician will contact the C5-C6 spinal segment. A thrust maneuver will be given by the contact hand of the clinician with the supportive hand resting on the subject's zygoma. A rotational inferior drop thrust maneuver will be completed. For the scSMT the subject's head will be rotated to 45 degrees and will be supported by the clinician's forearm, which will lie on top if the headpiece. A thrust maneuver will then be given by the contact hand of the treating clinician to the drop piece with the hand beside the paraspinal musculature simulating a real thrust, the supportive hand will be resting on the subject's zygoma. A inferior drop thrust will be applied to the drop piece (no thrust is made by the contact hand on the cervical spine).
16197070|NCT01418157|Drug|Acetazolamide|125 mg twice daily until 4380 meters altitude
16197071|NCT01418157|Drug|Placebo|Twice daily
16197072|NCT01418144|Procedure|Transversus abdominis plane (TAP) block|Bilateral UL-guided TAP block with 20 ml of ropivacaine 0,5%
16197073|NCT01418144|Procedure|Placebo TAP block|Bilateral placement of 20 ml of saline 0,9% in the transversus abdominis plane
16197074|NCT01418131|Drug|Rectal tacrolimus|Rectal tacrolimus made as an ointment at a concentration of 0.5mg/ml with 3 mls will be applied rectally twice a day
16197075|NCT01418131|Drug|Placebo|Placebo
16197076|NCT01418118|Drug|Epinephrine|0.2mcg/kg/min maximum infusion; to increase mean arterial pressure by 30mmHg
16197077|NCT01418118|Drug|Norepinephrine|Maximum infusion of 0.2mcg/kg/min, to increase mean arterial pressure by 30mmHg
16197078|NCT01418118|Drug|Dobutamine|Maximum infusion rate of 8mcg/kg/min to increase mean arterial pressure by 30mmHg
16197079|NCT01418118|Drug|Dopexamine|Maximum infusion rate of 5mcg/kg/min to increase mean arterial pressure by 30mmHg
16197080|NCT01418105|Procedure|Videofluroscopic swallow study (VFSS)|Barium, radiation
16197081|NCT01418105|Procedure|cervical spine isometric exercises|patients with cervical scoliosis will execute isometric exercises of the cervical spine
16197082|NCT01418105|Procedure|Fiberoptic endoscopic esophageal study (FEES)|food for swallowing
16197083|NCT01418092|Drug|ALKS 37|Capsules for oral administration
16197084|NCT01418092|Drug|Placebo|Capsules for oral administration
16197085|NCT01418079|Device|O2 MedTech cerebral oximeter (Oxygen desaturation)|Reduction in blood oxygen saturation by sequential reduction in inspired gas composition. Steps are of 6 minutes duration with reduction in pulse oximeter oxygen saturation from 100 to 70%.
16197086|NCT01418066|Drug|Ayurvedic Herbs|A tea made of Murraya koenigii leaves, Punica granatum and Curcuma as powder. Decoction of 12ml powder in 100ml hot water is taken twice daily at least 30 minutes before a meal.
16197087|NCT01418066|Drug|Placebo tea|Graminis Flores and Maidis stigmata as a powder. Decoction made of 12ml in 100ml hot water. To drink twice daily at least 30 Minutes before a meal.
16197088|NCT01418053|Drug|caraway oil|essential oil, Carum carvi, 2% dissolved in olive oil, 1 teaspoon with caraway oil used externally as inunction together with a hot cataplasm
16197089|NCT01418053|Drug|Olive oil|1 teaspoon with caraway oil used externally as inunction together with a hot or cold cataplasm as assigned
16197090|NCT01418027|Other|Intensive exercise|Subjects conduct an aerobic exercise at 65-80% maximum oxygen consumption for 30 minutes each day, five days a week, totally for 6 months.Subsequently, moderate physical activity(3.0-6.0 MET s) at 150 min/wk for 6 months.
16197091|NCT01418027|Other|Conventional exercise|Subjects receive moderate physical activity(3.0-6.0 MET s) at 150 min/wk(30 min per day, five days a week) for 12 months.
16197162|NCT01417299|Dietary Supplement|RPh201|Patients will receive 400 microliter s.c., of RPh201 twice a week for 3 months
16197277|NCT01416350|Drug|Azithromycin - 1000 mg|Part A - A single azithromycin dose of 1000 mg.
16197092|NCT01418001|Drug|Pazopanib 400 mg QD - Gemcitabine and Docetaxel in Combination|"Patients who meet the eligibility criteria above will be treated with the combination therapy of Gemcitabine, Docetaxel, and Pazopanib for two cycles and subsequently re-evaluated for treatment effect. If no progression of the tumor is seen, patients will continue with two more cycles of treatment (total four cycles). Those patients who have progression of disease will proceed directly to surgical resection.
~Following completion of neoadjuvant treatment, all patients will have definitive surgical resection. Following recovery from surgery, patients will proceed with adjuvant radiation therapy. Patients will then be followed for 2 years or until January 1st 2015, whichever comes first ."
16197093|NCT01417988|Drug|Experimental: Empiric TB treatment|Initiation of 4 drug TB treatment (8 weeks of 4 drug, 16 weeks of 2 drug therapy) followed by ART (efavirenz-based) within 2 weeks
16197094|NCT01417988|Drug|ART only arm|ART (efavirenz-based) only (+ pyridoxine 50mg) given within 2 weeks after enrolment
16197095|NCT01417975|Behavioral|Moderate Exercise Group|Participants will be required to walk briskly (equivalent to moderate intensity) on a treadmill for 10 minutes.
16197096|NCT01417975|Behavioral|Passive Sitting Group|Participants will be required to sit passively on a chair for 10 minutes.
16197097|NCT01417949|Other|Time of starting antiretroviral therapy|"Within 24 hours after sending the screening form, the site investigator will receive a randomization sheet with the decision when to start ART (immediate or deferred). The day of receiving the randomization sheet will be defined as baseline visit."
16197098|NCT01417936|Drug|Sym004|Sym004 will be administered at the dose of 12 milligram per kilogram (mg/kg) as an intravenous infusion every week up to disease progression or withdrawal from treatment.
16197099|NCT01417923|Drug|vitamin D|P.O.4000 units Vit D per day for 6 weeks
16197100|NCT01417897|Drug|Insulin glulisine|Dosage will be pro re nata. Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL.
16197101|NCT01417897|Drug|Insulin aspart|Dosage will be pro re nata. Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL.
16197102|NCT01417897|Drug|Regular human insulin|Dosage will be pro re nata. Patients should aim an blood glucose level of 2h ppBG ≤ 135 mg/dL.
16197103|NCT01417858|Procedure|YAG laser peripheral iridotomy|1 drop 30 minutes before yag laser iridotomy
16197104|NCT01417858|Procedure|YAG laser peripheral iridotomy|1 drop 30 minutes before yag laser iridotomy
16197105|NCT01417845|Behavioral|High Intensity Exercise Training|"High intensity resistance and aerobic training
~Resistance training is performed 2 days per week for 3 months
~Aerobic training is performed on the same days as resistance training and 1 additional day per week."
16197106|NCT01417845|Behavioral|Moderate Intensity Exercise Training|"Moderate intensity resistance and aerobic training
~Resistance training is performed on 2 days per week for 3 months.
~Aerobic training is performed on the same days as resistance training and 1 additional day per week."
16197107|NCT01417832|Drug|Resin infiltration / adhesive|Treatment at baseline of one caries lesion with a resin infiltration conducted under rubber-dam isolation with the Icon-DMG pre-product; treatment at baseline of another caries lesion with an adhesive under rubber-dam isolation with the Prime Bont NT - Dentsply.
16197108|NCT01417832|Drug|Placebo|In this split-mouth design study, one of the three randomly selected approximal lesions will be treated with an infiltrant resin, one will be treated with an adhesive resin.
16197109|NCT01417819|Other|Mobile short message service|Mobile short message service reminder for appointments of parents of cataract children
16197110|NCT01417806|Drug|Topotecan and Pasireotide|Topotecan 1.5mg/m2 dailyx5 days and Pasireotide 60 mg IM every 28 days
16197111|NCT01417793|Behavioral|Smoking Cessation Program|Comparison of smoking cessation rate among different smoking cessation program
16197112|NCT01417780|Drug|AB103|AB103 0.25 mg/kg or 0.5 mg/kg administered as a single IV infusion
16197113|NCT01417780|Drug|Placebo|Normal saline (0.9% sodium chloride) administered as a single IV infusion
16197114|NCT01417767|Drug|CHG regimen|cytarabine (25mg/d, days1-14) and homoharringtonine (1mg/d, days1-14) by intravenous continuous infusion, G-CSF (300 μg/d) by subcutaneous injection from day 0 until neutrophil count recovery to 2.0× 109/L.
16197115|NCT01417767|Drug|5-aza-deoxycytidine|Decitabine (5-aza-deoxycytidine)for injection, 20mg/m2/day, IV (in the vein) on days 1-5 of each 28 day cycle, Number of Cycles: 2.
16197116|NCT01417754|Drug|Toremifene|20mg toremifene per day in tablet form starting from the cycle day 15 and continued to premenstrual period. Medication using about 10 days per volunteer
16197117|NCT01417741|Device|Acupuncture Needle|A small 1.8 mm needle to be placed in the P6 acupuncture point on the wrist
16197118|NCT01417715|Device|Endomicroscopy|Patients will undergo advanced endoscopic imaging using endomicroscopy. Findings will be compared to histopathological and clinical results.
16197119|NCT01417702|Device|High-definition white light endoscopy and i-Scan|Patients will undergo advanced endoscopic imaging. Findings will be compared to histopathological and clinical results.
16197120|NCT01417689|Other|Encouragement to attempt eye drop instillation with a specific technique|Encouragement to one of the 2 techniques (open eyes and closed eyes) is accomplished through a standardized educational session designed to take2-5 minutes.
16197121|NCT01417676|Radiation|Radiation: pelvic lymph nodes with boost to prostate|78(74)Gy/39(37) fractions to prostate, 56(55)GY /39(37) fractions to pelvic lymph nodes, 5 fractions per week.
16197122|NCT01417663|Drug|Alt-711|Alt-711, also known as Alagebrium, an AGE-crosslink breaker, will be given twice daily 100mg
16197123|NCT01417663|Behavioral|Physical exercise training|Exercise training will be given three times a week for 45 minutes per training session. The heart rate reserve will be slowly increased from 70% to 85%.
16197124|NCT01417650|Radiation|Low level laser therapy|In this group, the 890 nm diode laser (Mustang 2000+, Russia) will be applied with frequency of 1500 Hz, and dose of 2 J/cm2 per point in the joint area and painful muscles if any.
16197125|NCT01417650|Radiation|Low level laser therapy|In this group, the low level laser will be applied with a minimal dose that is very lower than the threshold necessary for therapeutic effects.
16197126|NCT01417637|Radiation|Low level laser therapy|Ga As diode laser (890 nm) Mustang 2000+, Russia), with frequency of 1500 Hz, and dose of 2 J/cm2 per point in the painful muscles. Laser therapy will be applied on all painful muscles three times a week for four weeks.
16197163|NCT01417299|Dietary Supplement|saline|Patients will receive 400 microliter s.c., of saline twice a week for 3 months
16197310|NCT01416116|Drug|Lidocaine|topical
16197127|NCT01417637|Radiation|Placebo group|In this group, the low power laser will be applied with a minimal dose that is very lower than the threshold necessary for therapeutic effects. Laser therapy will be applied on all painful muscles three times a week for four weeks.
16197128|NCT01417624|Other|CMR Guidance in terms of guiding LV lead implantation|"Following randomisation, the optimal position of the LV lead will be determined either according to current standard criteria (as proposed by the primary operator) or with CMR guidance.
~The CRT device will be implanted using established conventional techniques. The CMR study will be performed pre-implantation only. The distribution of myocardial scar and fibrosis will be derived from this study. A CMR venogram will also be generated and the suggested optimal venous tributaries of the great cardiac vein will be identified from discussion between the principal investigator and senior CMR physician. This information will be used for those in the active arm only."
16197129|NCT01417611|Procedure|i-scan CE, SE, TE mode|I-scan technology is the newly developed image enhanced endoscopy technology, classified as a digital contrast method among endoscopic imaging techniques. I-scan has three modes of image enhancement, i.e. surface enhancement (SE); contrast enhancement (CE); and tone enhancement (TE). The three modes (SE, CE and TE) are arranged in series, therefore, it is possible to apply two or more of these three modes at one time. Switching the levels or modes of enhancements can be done on a real-time basis, without any time lag by pushing a relevant button, thus enabling efficient endoscopic observation.
16197130|NCT01417598|Other|Gait and balance group training|The balance-training program is based on scientifically well-established principles of exercise training and postural control as well as current research on training in elderly and PD. For the PD group it has been modified based on the current knowledge of the neurophysiology and the inevitable constraints on mobility and postural control resulting from basal ganglia degeneration. The training will be conducted as a progressive individually adjusted group program, led by experienced physiotherapists and researchers in order to challenge the specific balance disorder of every participant and endorse progression. It is progressive and specific balance program including dual- and multitasks. The program is performed 3 times/week for 10-12 weeks.
16197131|NCT01417598|Other|Nordic walking (only osteoporosis group)|To further test the hypothesis that physical activity may enhance the results from the balance training program pole striding will be added to the balance training program, at least 30-45 minutes three times per week during leisure time. Each individual in this group will be provided with individually adjusted poles, a pedometer and a diary to enter when and for how long time they have been walking.
16197132|NCT01417585|Behavioral|Client-centered ADL intervention|Client-centered ADL refers to rehabilitation of activities of daily living specifically guided by the needs as expressed by the client/patient and her/his significant others, a process that specifically aims to support the client by taking the client's goals and views as the guide for the rehabilitation process.
16197133|NCT01417585|Behavioral|Usual ADL intervention|The variation of strategies and ways to conduct usual ADL rehabilitation according to the routines and praxis of the participating rehabilitation units randomized to supply the control condition.
16197134|NCT01417572|Drug|lidocaine|to evaluate the effect of lidocaine on oculocardiac reflex during the surgery
16197136|NCT01417507|Procedure|cognitive assessment|Undergo neurocognitive assessment
16197137|NCT01417507|Procedure|magnetic resonance imaging|Undergo MRI
16197138|NCT01417507|Other|laboratory biomarker analysis|Correlative studies
16197139|NCT01417507|Other|questionnaire administration|Ancillary studies
16197140|NCT01417507|Procedure|quality-of-life assessment|Ancillary studies
16197141|NCT01417494|Drug|Chemotherapy ( FOLFIRI regimen, FOLFOX regimen or LV5FU2 regimen)|
16197142|NCT01417494|Drug|Chemotherapy ( FOLFIRI regimen, FOLFOX regimen or LV5FU2 regimen) + bevacizumab|
16197143|NCT01417481|Dietary Supplement|Glycine|Daily oral supplement of glycine at a dose of 0.5 g/kg divided in three doses during 8 weeks
16197144|NCT01417481|Dietary Supplement|Placebo|Daily oral administration of placebo (sugar glass) at a dose of 0.5 g/kg divided in three doses during 8 weeks
16197145|NCT01417468|Behavioral|CLSI, MI, CR|(CLSI) Canfield Learning Styles Inventory (MI) Multiple Intelligences (CR) Cognitive Rehabilitation
16197146|NCT01417468|Behavioral|CLSI - Unknown|(CLSI) Canfield Learning Styles Inventory (MI) Multiple Intelligences (CR) Cognitive Rehabilitation
16197147|NCT01417442|Genetic|BRAF V600E POSITIVITY|BRAF V600E mutation analysis will be made using the tumor tissues of the patients with papillary thyroid cancer (3 sections of 7 mm from he paraffin blocks). And mutation positives and negatives will be identified.
16197148|NCT01417429|Drug|Galantamine|8mg/a day or placebo
16197149|NCT01417429|Drug|IV Nicotine|1.0 mg/70 kg of nicotine against saline
16197150|NCT01417403|Drug|hydroxychloroquine|Given PO
16197151|NCT01417403|Radiation|radiation therapy|Undergo radiotherapy
16197152|NCT01417390|Drug|Drug: Gemcitabine and cisplatin|Patients receive Gemcitabine (1000mg/m2 on day 1,8) and cisplatin (20mg/m2 on day 1-4) every three weeks for two cycles before the radiotherapy, then receive radical radiotherapy with IMRT and cisplatin (40mg/m2) every week for six cycles during radiotherapy.
16197153|NCT01417390|Drug|Cisplatin|Patients receive radical radiotherapy and cisplatin (40mg/m2) every week for six cycles during radiotherapy
16197154|NCT01417377|Drug|Mircera|Participants with chronic kidney disease receiving methoxy polyethylene glycol-epoetin beta (Mircera) and previously on treatment with short-acting epoetin alpha will be observed for a period of 6 months.
16197155|NCT01417364|Drug|Testosterone enanthate|100 mg. IM weekly throughout study
16197156|NCT01417364|Drug|Testosterone enanthate|100 mg IM weekly for one month alternating with placebo injections for one month throughout the study
16197157|NCT01417364|Drug|Placebo|Injected IM weekly throughout study
16197158|NCT01417351|Dietary Supplement|400 IU vitamin D3|Women in this study arm receive 400 IU of vitamin D3 per day, or what is in a standard prenatal multivitamin. They also receive a placebo study supplement.
16197159|NCT01417351|Dietary Supplement|2,000 IU Vitamin D3|Women in this arm receive 2,000 IU vitamin D per day: 400 IU from a standard prenatal multivitamin plus an additional 1,600 IU vitamin D3 in the study supplement.
16197160|NCT01417312|Dietary Supplement|Capsules with 160 mg Teavigo (at least 94% EGCG)|Daily intake of 600 mg EGCG for 3 months
16197311|NCT01416116|Drug|Tramadol|oral
16197164|NCT01417286|Radiation|External beam radiation therapy|Hypofractionated accelerated radiation therapy over 11 days
16197165|NCT01417273|Dietary Supplement|vitamin A|1 cap vitamin A 25000 IU/day for 6 months and 10000 IU/day for next 6 months
16197166|NCT01417273|Drug|Drug: placebo|1 cap placebo/day for 12 month
16197167|NCT01417247|Procedure|renal sympathetic modification|Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure
16197168|NCT01417234|Device|SNaP® Wound Care System|Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
16197169|NCT01417221|Procedure|renal sympathetic modification|Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure
16197170|NCT01417208|Device|SNaP® Wound Care System|Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
16197171|NCT01417195|Drug|Bravelle|
16197172|NCT01417195|Drug|Menopur|
16197173|NCT01417182|Drug|18F-DCFBC|A bolus of 10 mCi (370 MBq) of 18F-DCFBC will be injected once into the IV line by slow push IV push.
16197174|NCT01417169|Drug|micafungin|Eligible patients who provided informed consent form will be administered micafungin at 50 mg/day (1mg/kg/day for patients weighting <50kg) as 1-h infusion. Infusion of Micafungin will be started on the day -2 of the conditioning course of autologous stem cell transplantation
16197175|NCT01417156|Drug|Nintedanib|150 mg bid
16197176|NCT01417156|Drug|Pirfenidoneone|Existing treatment
16197177|NCT01417143|Drug|TKI258 (Dovitinib):|TKI258 (Dovitinib): 500 mg daily po medication with 5 days on/2 days off schedule. TKI258 (Dovitinib) will be provided by Norvatis for the study purpose. One cycle consists of 4 weeks
16197178|NCT01417104|Drug|Aliskiren|150 mg/300mg
16197179|NCT01417104|Drug|Placebo|150mg/300mg
16197180|NCT01417091|Drug|BPS804|
16197181|NCT01417078|Drug|Diazepam|single-dose; dosage in mg, based on patient body weight
16197182|NCT01417065|Drug|Temsirolimus|Starting dose will be 0.02 mg intravenous administered once on Day 1 over 60 minutes.
16197183|NCT01417052|Drug|50 mg LX3305 QD|50 mg LX3305 once daily in capsule form
16197184|NCT01417052|Drug|100 mg LX3305 QD|100 mg LX3305 once daily in capsule form
16197185|NCT01417052|Drug|150 mg LX3305 QD|150 mg LX3305 once daily in capsule form
16197186|NCT01417052|Drug|200 mg LX3305 QD|200 mg LX3305 once daily in capsule form
16197187|NCT01417052|Drug|250 mg LX3305 QD|250 mg LX3305 once daily in capsule form
16197188|NCT01417052|Drug|300 mg LX3305 QD|300 mg LX3305 once daily in capsule form
16197189|NCT01417052|Drug|400 mg LX3305 QD|400 mg LX3305 once daily in capsule form
16197190|NCT01417052|Drug|250 mg LX3305 BID|250 mg LX3305 twice daily in capsule form
16197191|NCT01417052|Drug|500 mg LX3305 QD|500 mg LX3305 once daily in capsule form
16197192|NCT01417052|Drug|Placebo|Matching placebo dosing in capsule form
16197193|NCT01417026|Drug|Intranasal Oxytocin (Trade name: Syntocinon)|This is a double-blind placebo-controlled trial of intranasal oxytocin in children and adolescents with ASD. Subjects will be randomized to 24 IU intranasal oxytocin or placebo for a 5 day period with concomitant game play of computer games, which are designed to enhance face perception skills. Measures of social function and cognition will be administered before and after the intervention period.
16197194|NCT01417013|Other|Systane Ultra|Lubricant Eye Drops
16197195|NCT01417013|Other|Optive|Lubricant eye drops
16197196|NCT01417000|Biological|GVAX Pancreas|
16197197|NCT01417000|Biological|CRS-207|
16197198|NCT01417000|Drug|Cyclophosphamide|
16197199|NCT01416987|Drug|Pergoveris®|Participants received once daily injection of a single vial of Pergoveris® which contained 150 International Units (IU) of follitropin alfa (r-hFSH) and 75 IU of lutropin alfa (r-hLH), for approximately 8 days.
16197200|NCT01416974|Drug|cyclophosphamide|Patients will first receive a single infusion of therapy conditioning with cyclophosphamide.
16197201|NCT01416974|Biological|modified T cells|followed by consolidative therapy with the modified T cells in 3 planned cohorts.
16197202|NCT01416961|Radiation|Radiation Therapy|Concurrent chemo and photon radiation therapy will start within 7 days of completing neutron therapy. There will be a Day 1 of neutron therapy and a Day 1 of concurrent therapy.Photon radiation therapy will begin within 24 hours of the first cycle of chemotherapy and will be delivered 5 days per week, one fraction per day, in 1.8 Gy per fraction. High LET radiotherapy will be delivered in 1 NGy per fraction five days per week. High LET radiotherapy will be delivered first followed by combined chemoradiotherapy.
16197203|NCT01416961|Drug|Chemotherapy - Squamous Cell Histologies|Cisplatin 50 mg/m2 administered on days 1,8, 29, 36; Etoposide 50 mg/m2 administered on days 1-5 and then again days 29-33
16197204|NCT01416961|Drug|Chemotherapy - NSCLC other than squamous cell|Cisplatin 75 mg/m2 days 1,22,43; Pemetrexed 500 mg/m2 days 1,22,43
16197205|NCT01416948|Drug|Methylphenidate Hydrochloride 20 mg|For patients assigned to the MPH arm of the study, the drug will be initiated at 5 mg bid at week 0, and increased to 10 mg bid at week 4, and finally increased to 20 mg bid at week 8 and then held constant until the major outcome assessment at week 12. The drug will be gradually tapered during weeks 12-14. If adverse events ensue, the subject's dose can be held at the current dose (rather than proceeding with scheduled dose increases) or reduced to the previous dose. Subjects who cannot tolerate the minimum dose (5 mg bid) will be withdrawn from the study.
16197206|NCT01416948|Drug|Placebo Capsule|For patients randomly assigned to the placebo arm of the study, placebo will be administered BID at Week 0 through Week 12. Matching placebo will be administered to match the taper period.
16197207|NCT01416948|Drug|Galantamine 12 mg|For patients randomly assigned to the GAL arm of the study, the drug will be initiated at 4 mg bid at week 0, increased to 8 mg bid at week 4, and finally increased to 12 mg bid at week 8 and then held constant until the major outcome assessment at week 12. The drug will be gradually tapered during weeks 12-14. If adverse events ensue, the subject's dose can be held at the current dose (rather than proceeding with scheduled dose increases) or reduced to the previous dose. Subjects who cannot tolerate the minimum dose (4 mg bid) will be withdrawn from the study.
16197274|NCT01416363|Drug|Firategrast modified release tablet|Firategrast modified release tablet is white to slightly colored 600 mg unit dose and subjects will administer it with 240 mL of water.
16197350|NCT01415778|Drug|Casodex 80 mg tablet|Subject will receive single dose of Casodex 80 mg tablet
16197208|NCT01416935|Other|No Amiodarone|This is a randomized study whereby patients who would routinely/usually be scheduled to receive Amiodarone as their anti-arrhythmic medication post surgical ablation will be randomly assigned to receive Amiodarone or no Amiodarone, but all other medications would remain as prescribed for patients following surgical ablation which will include beta blockade therapy unless contraindicated which is an American Heart Associated and Heart Rhythm Society recognized treatment.
16197209|NCT01416909|Other|Laxative Treatment|Participants will be taken off any laxative preparation they may already be on. Patients will be put on laxative treatment based on the Constipation Treatment Protocol.
16197210|NCT01416909|Other|Standard of Care|Participants will receive their usual care at Moffitt while participating in weekly assessments. After participation in the study is complete, participants will be offered the same protocol that is given to patients in the treatment groups.
16197211|NCT01416909|Other|Assessment Questionnaires|Constipation Assessment Scale (CAS), Laxative Interview (based on Laxative Diary completed by patients), Memorial Symptom Assessment Scale (MSAS), Functional Assessment of Cancer Therapy-General (FACT-G).
16197212|NCT01416896|Procedure|Hemodialysis using the standard venous needle|Hemodialysis using the standard venous dialysis needle
16197213|NCT01416896|Procedure|"Hemodialysis using a new venous needle, the BME needle"|"Hemodialysis using a new venous dialysis needle or the BME needle"
16197214|NCT01416896|Procedure|"Hemodialysis using a new venous needle, the BME needle"|"One hemodialysis using a new venous needle, the BME needle"
16197215|NCT01416896|Procedure|Hemodialysis using the standard venous needle|One hemodialysis using the standard venous needle
16197216|NCT01416883|Drug|ICI176,334-1|Subject will receive single dose of ICI176,334-1
16197217|NCT01416870|Drug|ICI176,334-1|Subject will receive single dose of ICI176,334-1
16197218|NCT01416870|Drug|Casodex 80 mg tablet|Subject will receive single dose of Casodex 80 mg tablet
16197219|NCT01416857|Other|RDDT|
16197220|NCT01416844|Biological|anti-OX40|Patients with metastatic melanoma will be given 0.4 mg/kg anti-OX40 on days 1, 3 and 5 of a single treatment cycle.
16197221|NCT01416831|Other|Radiation therapy and high-dose IL-2|Patients 1 - 20 will receive a single fraction of radiation. Patients 21 through the completion of the study will receive two fractions. The dose for all patients will be 20 Gy per fraction to the prescription line at the edge of the planning treatment volume (PTV) with the last dose delivered on a Friday before IL-2 administration. For patients receiving two radiation doses, the doses can be administered on the Wednesday and Friday before IL-2 starts. Patients who are assigned to IL-2 monotherapy and have progressive disease after two IL-2 cycles are then eligible to receive SBRT before cycle 3 of IL-2 commences, single fraction for patients 1-20 and two fractions for patients 21- end of study.
16197222|NCT01416831|Drug|High-dose IL-2|IL-2 will be given on a Monday at a dose of 600,000 IU per kilogram IV every 8 hours for up to 14 doses each cycle. The second cycle is planned 16 days after cycle 1 but may be delayed up to one week to allow toxicity to resolve. The maximum number of doses that can be given during two cycles will be 28 doses. Patients who respond after two cycles can receive 4 more cycles of IL-2. Patients with disease progression after 2 cycles may elect to receive radiation before a 3rd cycle of IL-2. If patients crossover, IL-2 will be given on the Monday following the last dose of radiation, at a dose of 600,000 IU per kilogram IV every 8 hours for a maximum of 14 doses each cycle. Another cycle is planned 16 days after cycle 3 but may be delayed up to one week to allow toxicity to resolve.
16197223|NCT01416818|Drug|Xiaoyao Pill|herb extracts,were received two times a day for 12 weeks without dose changing.
16197224|NCT01416818|Drug|Bupleurum+Ginkgo|herb extracts, were received two times a day for 12 weeks without dose changing.
16197225|NCT01416818|Drug|placebo|The placebo looked like herb extracts and were also received two times a day for 12 weeks without dose changing.
16197226|NCT01416805|Behavioral|Computerized Cognitive Behavioral Therapy|Those who choose to participate will be enrolled in the 14 week study (18 weeks for phase II). They will required to attend 3 assessments - pre-treatment (week 0), mid-treatment (week 8), and post-treatment (week 14) (and a 4th assessment for a 1 month Follow-up for Phase II at week 18). This group will follow the CCBT protocol (Camp Cope-A-lot), which is the computer-assisted intervention for anxious children being examined in this study. The first 6 levels of this program are skill building levels to be completed by the user in his/her own home. The remaining 6 levels are completed with the therapist and consist of exposure tasks and rehearsal geared toward each child.
16197227|NCT01416805|Behavioral|Treatment as usual|Those who choose to participate will be enrolled in the 14 week study (18 weeks for phase II). They will required to attend 3 assessments - pre-treatment (week 0), mid-treatment (week 8), and post-treatment (week 14) (and a 4th assessment for a 1 month Follow-up for Phase II at week 18). Those in this group will not receive the CCBT, and instead will undergo therapy for their anxiety as they usually would, whether by using medication or working with a therapist.
16197228|NCT01416792|Procedure|Centrifugation|
16197229|NCT01416792|Procedure|Multiple-pass hemofiltration|The residual volume from the CPB circuit is pumped though a hemofilter for multiple passes removing the crystalloid component thereby concentrating the plasma.
16197230|NCT01416779|Behavioral|Writing Intervention|Finding Balance Writing Intervention
16197231|NCT01416766|Other|Self-monitoring-nurse-primary care provider feedback loop|Intervention participants will receive an Omron BP monitor and assistance in setting it up to upload BP data to Reliant Medical Group from a home/work or clinic-based computer. They will be encouraged to upload readings at least once/month. Diabetes management nurses will receive the readings and, if a participant's mean BP is not at target, will follow protocols to address this, contacting PCPs as indicated by protocols.
16197232|NCT01416753|Device|UCR|BVM-based regulation of ultrafiltration and conductivity
16197233|NCT01416753|Device|UTR|BVM-based regulation of ultrafiltration; regulation of temperature
16197234|NCT01416740|Procedure|Indirect MRA of shoulder|Patient will be weighed and the correct dose of 0.1 mmol/kg calculated. An IV will be inserted into patient's arm. The gadopentetate dimeglumine will be injected into the IV and the patient is asked to gently exercise the shoulder (small windmills and flexion/extension) for 5 minutes. The patients then undergo MRI imaging 15-30 minutes after the injection. Contraindications include known allergy to gadopentetate dimeglumine, and renal failure with creatinine clearance of less than 30ml/min.
16197275|NCT01416363|Drug|Firategrast gastro-retentive solution|Firategrast solution is clear colorless solution and subject will administer it via nasogastric route.
16197235|NCT01416740|Drug|Gadopentetate Dimeglumine|Patient will be weighed and the correct dose of 0.1 mmol/kg calculated. An IV will be inserted into patient's arm. The gadopentetate dimeglumine will be injected into the IV and the patient is asked to gently exercise the shoulder (small windmills and flexion/extension) for 5 minutes. The patients then undergo MRI imaging 15-30 minutes after the injection. Contraindications include known allergy to gadopentetate dimeglumine, and renal failure with creatinine clearance of less than 30ml/min.
16197236|NCT01416727|Other|Emergency Psychiatry Immersion Course|A two-day simulation-based training course covering assessment of self-harm, capacity, managing aggression, working with the emergency team and medical emergencies in the psychiatric hospital
16197237|NCT01416727|Other|Observed SKills in the Emergency Room|For four weeks, participants will be accompanied by a senior psychiatric registrar or consultant psychiatrist, who has received training in giving feedback, during their on-call duties. Each participant will receive between 8-12 hours of 1:1 training.
16197238|NCT01416701|Dietary Supplement|Vitamin D (D3, cholecalciferol)|Week 0-4: 152 mcg/daily (4 tablets) Week 5-52: 76 mcg/daily (2 tablets)
16197239|NCT01416701|Dietary Supplement|Placebo (cellulose)|Week 0-4: 4 tablets daily Week 4-52: 2 tablets daily
16197240|NCT01416688|Procedure|assessment of therapy complications|Will be given by questionnaire
16197241|NCT01416688|Procedure|psychosocial assessment and care|Will be given by questionnaire
16197242|NCT01416688|Procedure|quality-of-life assessment|Will be given by questionnaire
16197243|NCT01416662|Drug|gemcitabine hydrochloride|
16197244|NCT01416649|Drug|Exenatide|Exenatide is started for the treatment of type 2 diabetes as determined by the patients regular physician. The dose will be 5-10 micrograms twice daily which is the standard dose. The medication is given by self-administered subcutaneous injection. The medication may continue for the treatment of the type 2 diabetes after the study is completed after 3 months.
16197245|NCT01416636|Drug|Treprostinil sodium|
16197246|NCT01416623|Drug|henatinib|Henatinib Maleate Tablets
16197247|NCT01416597|Biological|Vaccines|Unadjuvanted, monovalent, and trivalent vaccines, and vaccines delivered intramuscularly, intradermally, or intranasally, depending on what is found in the included studies.
16197248|NCT01416584|Behavioral|methadone contingency|Participants had to enroll in methadone treatment and take daily doses of methadone to gain access to the workplace.
16197249|NCT01416584|Behavioral|Methadone & Abstinence Contingency|Participants had to enroll in methadone treatment and take daily doses of methadone to gain access to the workplace and they had to provide opiate and cocaine negative urine samples to maintain the maximum pay.
16197250|NCT01416571|Biological|Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted|Intramuscular (IM), two doses
16197251|NCT01416558|Drug|Nab-Paclitaxel|"Nab-Paclitaxel 125 mg/m2 i.v. over 30 min. weekly in 5 out of 6 weeks
~Given until progression, unacceptable toxicity, patient's request or withdrawal from Study"
16197252|NCT01416545|Behavioral|Educational program in cardiovascular prevention|a weekly educational program in cardiovascular prevention with a multidisciplinary heath team during the year 2010. This intervention tried to teach to these children, in different manners appropriate for their age, concepts of healthy nutrition, avoidance of tobacco and physical activity. Both at the inclusion in the study and one year later we collect data of parents and their children of the two groups, in a single weekend, including nutritional and exercise survey, measures of weigh, height, waist circumference, arterial blood pressure, and laboratorial exams.
16197253|NCT01416545|Behavioral|Lifestyle counseling|The control group received written educational material directed for their parents and related to healthy lifestyle (nutrition, exercise and smoke quitting).
16197254|NCT01416519|Procedure|Continuous Positive Airway Pressure (CPAP) facial mask|After extubation, starting non-invasive ventilation with face mask (1 hour) followed by assisted cough maneuver. Total of 18 calls in 72 hours distributed as long the patient was extubated.
16197255|NCT01416519|Procedure|Assisted deep inspiration technique|After extubation, starting early supplemental oxygen with Venturi (FiO2 50%) with gradual weaning, applying assisted deep inspiration technique with Voldyne(R) with four sets of 10 repetitions and assisted cough maneuver. Total of 18 calls in 72 hours distributed as long the patient was extubated.
16197256|NCT01416506|Other|No Drug|It's a surveillance
16197257|NCT01416493|Drug|s.c. injections of bovine intestinal Alkaline Phosphatase|daily subcutaneous treatment with two injections of 2000IU bIAP for three days
16197258|NCT01416480|Drug|Theobromine 300mg|Capsule, b.i.d.
16197259|NCT01416480|Drug|Levodropropizine 10mg|Syrup, t.i.d.
16197260|NCT01416441|Drug|Aripiprazole|Aripiprazole tablets orally once daily.
16197261|NCT01416428|Drug|oprozomib|Patients enrolled will receive Oprozomib Tablets once daily either on Days 1-5 (QDx5 schedule) or on Days 1, 2, 8, and 9 (QDx2 weekly schedule) of the 14-day treatment cycle.
16197262|NCT01416415|Other|Video education on proper eye drop instillation technique|The video is approximately seven minutes long and teaches the Robert Ritch method of instilling eye drops.
16197263|NCT01416415|Other|Placebo video education on healthy eating tips|The video is approximately seven minutes long and teaches tips to promote healthy eating.
16197264|NCT01416402|Drug|Arhalofenate|400 mg once daily orally for two weeks then up-titrated to 600 mg once daily orally for an additional two weeks
16197265|NCT01416402|Drug|Febuxostat|80 mg once daily orally for 5 weeks
16197266|NCT01416402|Drug|Colchicine|Colchicine 0.6 mg daily as prophylaxis to prevent gout flares
16197267|NCT01416389|Drug|LY2523355|Administered intravenously as a one hour infusion
16197268|NCT01416389|Drug|ixabepilone|Administered intravenously
16197269|NCT01416389|Drug|pegfilgrastim|Administered intravenously
16197270|NCT01416389|Drug|filgrastim|Administered intravenously
16197271|NCT01416376|Drug|SRT2379|SRT2379 is supplied as hard gelatin capsules containing either 25mg or 250mg free-base equivalent of SRT23790 drug substance as its succinate salt.
16197272|NCT01416376|Drug|Placebo|For the placebo capsules, the SRT2379 drug substance will be replaced by microcrystalline cellulose (Avicel PH200) to visually match the SRT2379 investigational product.
16197273|NCT01416363|Drug|Firategrast immediate release tablet|Firategrast immediate release tablet is white to pale cream colored 300 mg unit dose and subjects will administer it with 240 milliliter (mL) of water.
16197276|NCT01416350|Drug|Azithromycin - 250 mg|Part A - A single azithromycin dose of 250 mg.
16197278|NCT01416350|Drug|Azithromycin - 250 mg every other day for 3 weeks|Part B - Repeat dose study treating subjects with Azithromycin (250 mg every other day for 3 weeks), the dose approximates that used in the treatment of chronic neutrophil-related inflammatory conditions.
16197279|NCT01416337|Drug|GSK1120212|2 mg single dose tablet on Day 1 of study
16197280|NCT01416337|Drug|GSK1120212B|A single administration of a slow 1 minute IV push on Day 1.
16197281|NCT01416324|Drug|placebo|Vehicle used to dilute the powder for oral administration.
16197282|NCT01416324|Drug|0.1 mg GSK2330672|GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.
16197283|NCT01416324|Drug|0.3 mg GSK2330672|GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.
16197284|NCT01416324|Drug|1 mg GSK2330672|GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.
16197285|NCT01416324|Drug|3 mg GSK2330672|GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.
16197286|NCT01416324|Drug|10 mg GSK2330672|GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.
16197287|NCT01416324|Drug|30 mg GSK2330672|GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.
16197288|NCT01416324|Drug|60 mg GSK2330672|GSK2330672 is available as a white to almost white solid powder diluted in vehicle for oral administration.
16197289|NCT01416311|Drug|Eltrombopag|
16197290|NCT01416298|Other|Continuous Renal Replacement Therapy|The investigators will use the NGAL data daily to 1) drive initiation of CRRT in children with elevated NGAL and > 10-20% fluid overload and 2) drive CRRT discontinuation in patients with decreasing NGAL concentrations. All members of the Critical Care Medicine and Nephrology divisions have agreed that initiation of CRRT within 24-48 hours of a patient reaching >10% fluid overload is clinically acceptable, and that often the decision to start CRRT has been arbitrary in the past, based on physician bias or preference. All members agree that the current standard of 24-48 hours after >10% is achieved is acceptable and now will be put into standard clinical practice.
16197291|NCT01416272|Device|KeraSoft IC Soft Contact Lenses|Lenses will be worn between 8 and 16 hrs each day, for 12 months
16197292|NCT01416259|Drug|Withdraw treatment|
16197293|NCT01416246|Procedure|Fractionated Stem Cell Infusions|Following enrollment patients will be treated with melphalan intravenously (IV) through a central venous catheter (CVC) over 30 minutes at 200mg/m2 or 140mg/m2 (if creatinine clearance is < or = to 50 and/or age > 70 years) on day -2. Following 24 hours of rest, the first dose of CD34+ stem cell will be administered on day 0 (2.5-5 x 106 CD 34+ stem cells/kg)+/- 0.5 x 106 CD34+ stem cells/kg), followed by 3 additional doses of CD 34+ stem cells (1.5-2.5 x 106 CD 34+ stem cells/kg)+/- 0.5 x 106 CD34+ stem cells/kg) on days +2, +4, and +6. Pegfilgrastim 6μg will be administered on day +1. Filgrastim 5μg/kg will be 12-24 hours after the 2nd-4th stem cell infusions. There will be a +/- 1 day window for the Day +2, +4, and +6 infusions to accommodate infusions that occur over the weekend or on holidays.
16197294|NCT01416233|Procedure|autologous fat grafting to the orbit|subjects will undergo fat harvesting followed by autologous fat grafting into the orbit into their anophthalmic orbit
16197295|NCT01416220|Drug|Lithium|"Study drug will be packaged and supplied in an open-label fashion. There will be a washout period of all active psychotropic medication. Psychotropics will be withdrawn over 5 half-lives with the exception of drugs known to cause withdrawal symptoms (primarily antidepressants), which will be tapered over 10 days.
~Following the enrollment period, subjects will enter a six-week randomized treatment period with either lithium or paroxetine. Lithium carbonate will be commenced at 600mgs hs, with increase to 900mgs at day 7. Dose will be flexibly titrated to give a serum level between 0.5 and 1.1mmol/l. At visit 4, the dose of lithium may be adjusted (within the range of 0.6 and 1.1 mmol/l."
16197296|NCT01416220|Drug|Paroxetine|"Study drug will be packaged and supplied in an open-label fashion. There will be a washout period of all active psychotropic medication. Psychotropics will be withdrawn over 5 half-lives with the exception of drugs known to cause withdrawal symptoms (primarily antidepressants), which will be tapered over 10 days.
~Following the enrollment period, subjects will enter a six-week randomized treatment period with either lithium or paroxetine. Paroxetine will be commenced at 10mgs and increased to 20mgs on day 7. At visit 4, the dose of paroxetine may be increased to 40mgs, if there is no response (less than 20% reduction in MADRS score) as per current Canadian guidelines."
16197297|NCT01416207|Drug|Avonex|4 weekly injections of Avonex (IM)
16197298|NCT01416194|Drug|Bazedoxifene|Patients receiving Bazedoxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.
16197299|NCT01416194|Drug|Bisphosphonate|Patients receiving Bisphosphonates in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.
16197300|NCT01416194|Drug|Raloxifene|Patients receiving Raloxifene in usual clinical care. In this non-interventional study there is no protocol mandated drug assignment or dosing schedule.
16197301|NCT01416181|Drug|natalizumab|Administered as specified in the treatment arm
16197302|NCT01416181|Drug|Placebo|Matched placebo in part 1
16197303|NCT01416168|Other|McCorkle Model Intervention|The intervention will consist each week in a home visit and a phone call. The GNP conducting the home visit will identify current problems using a comprehensive geriatric assessment (CGA) and record problems on the Intervention and Recommendation Data Sheet. In addition, the cases will be reviewed at a weekly Intervention Team meeting between the intervention GNP (VM, CV), the geriatrician (VP), and the intervention PI (JO). That team meeting will also record how intervention goals for the various problems are met, using the instruments and criteria developed during our pilot study5. To ensure optimal consistency and an up-to-date evidence-based approach over the 4 years of the intervention, treatment recommendations will be offered according to national evidence-based treatment guidelines.
16197304|NCT01416155|Drug|natalizumab|
16197305|NCT01416142|Device|PureVision2 HD contact lenses|Lenses to be worn through 1/2 of an HD movie. Following the movie, all subjects were to wear the dispensed contact lenses on a daily wear basis for approximately one week.
16197306|NCT01416142|Device|Spectacles|Spectacles to be worn throughout 1/2 of an HD movie.
16197307|NCT01416129|Device|Standard of care socket|Amputees' preferred socket.
16197308|NCT01416129|Device|Prosthetic brimless socket|Study socket
16197309|NCT01416116|Drug|QUTENZA|topical
16197312|NCT01416103|Other|Intervention group|Alcohol treatment paralleling welfare-to-work participation: The participants are referred to the municipalities' outpatient alcohol treatment programmes and at the same time referred to an ordinary welfare-to-work programme.
16197313|NCT01416103|Other|Control group|The participants will as usual be referred to the welfare-to-work schemes deemed most appropriate by the caseworker. The intervention is no different than what the municipality would have offered if the participant was not part of the study.
16197314|NCT01416077|Other|fluid optimisation|"Stroke Volume and Cardiac Index are measured with the Flotrac/Vigileo system and circulation is optimised
~Crystalloid infusion (2,5 ml/kg/t) throughout surgery
~3 ml/kg Volulyte (artifical colloid) is infused during 5 minutes and SV is measured directly before and 5 minutes after. If SV increases more than 10% the dose is repeated until no increase > 10% is observed. A new dose is given if SV decreases more than 10% from the last value.
~If despite optimal filling Cardiac Index (CI) is below 2,5 l/min/m2 infusion with dobutamin is started to attain CI > 2,5.
~If despite CI > 2,5 Mean Arterial Pressure <65 mmHg vasopressor (phenylephrine / norepinephrine) is started until MAP equals or is over 65."
16197315|NCT01416064|Drug|Molindone|The populations will be comprised of male and female pediatric subjects from the 810P202 study. Subject will be converted to a total daily dose of 18 or 36mg of molindone (depending on weight), following enrollment into 810P203. The dosage level may be adjusted at the investigators discretion.
16197316|NCT01416051|Dietary Supplement|Olibra|Fractionated palm oil and fractionated oat oil in the proportion of 95:5
16197317|NCT01416051|Other|Placebo|100% milk fat
16197318|NCT01416038|Biological|DPX-Survivac|Vaccine targeting survivin antigen will be administered subcutaneously.
16197319|NCT01416038|Drug|low dose cyclophosphamide (oral)|Low dose cyclophosphamide will be taken by mouth.
16197320|NCT01416025|Drug|Prospective TDM Arm|Voriconazole dose will be adjusted based on per protocol obtained TDM levels
16197321|NCT01416012|Behavioral|Physical Therapy (standard)|This group consists of the usual physical therapy rehabilitation with a special emphasis on lower and upper limb and balance reinforcement.
16197322|NCT01416012|Behavioral|Balance and Gait training in Individualized sessions|The NW group consists of the use of Nintendo Wii games that targeted upper and lower limbs as well as balance reinforcement.
16197323|NCT01416012|Behavioral|Kinect|The NW group consists of the use of Nintendo Wii games that targeted upper and lower limbs as well as balance reinforcement
16197324|NCT01416012|Behavioral|Group Xbox Kinect|The NW group consists of the use of Nintendo Wii games that targeted upper and lower limbs as well as balance reinforcement
16197325|NCT01415986|Drug|Temoporfin|A single dose of 0.15 mg of Temoporfin per kilogram of body weight will be administered by slow intravenous injection into a deep vein (such as the antecubital vein) in not less than 6 minutes.
16197326|NCT01415986|Device|Medical diode laser emitting light at a wavelength of 652 nm. (Ceralas PDT 652, CeramOptec GmbH)|Light dose of 20 J/cm, at a rate of 100 mW/cm, will be delivered to the target tumor and margins, within 200 seconds.
16197327|NCT01415973|Dietary Supplement|3 ounces of cooked, 85% lean ground beef|Consumed once per subject.
16197328|NCT01415973|Dietary Supplement|20 grams beef protein isolate|Subjects would drink 200 ml water mixed with 20 grams of beef protein isolate one time.
16197329|NCT01415960|Drug|Leuprolide acetate 22.5 mg depot, GP-Pharm SA|Administered by im injection, twice during the study, three months apart
16197330|NCT01415947|Device|V Chordal|"V-Chordal system, consists in the ability to adjust (elongate or shorten) the neochordae off-pump . The adjustment mechanism allows overcoming the main problem of chordal replacement by enabling accurate sizing of the chords."
16197331|NCT01415934|Other|discontinue statins|patients will be randomized to either continue taking statins or discontinue.
16197332|NCT01415921|Drug|Pyridostigmine Bromide|15, 30, and 60 mg tabs, 1 tab every 8 hours for 10 weeks. Forced titration protocol increases dose at 2 week intervals from 15 to 30 to 60 mg as tolerated. Continue maximally tolerated dose for 4 weeks and then downtitrate at weekly intervals (60 to 30 to 15) and then discontinue.
16197333|NCT01415908|Device|INFUSE Bone Graft|Subjects enrolled in the investigational treatment group will receive surgical treatment with INFUSE® Bone Graft, the CAPSTONE® Spinal System, and posterior supplemental fixation (in this study the CD HORIZON® Spinal System). The investigational treatment will be implanted using a TLIF surgical approach.
16197334|NCT01415908|Other|Iliac Crest Bone Graft|Subjects enrolled in the control group will receive the same surgical treatment as the investigational group, including the CAPSTONE® Spinal System and posterior supplemental fixation system (CD HORIZON® Spinal System), except for the use of autogenous bone graft (from the iliac crest) instead of INFUSE® Bone Graft. A TLIF surgical approach will also be used for implanting the control treatment.
16197335|NCT01415895|Drug|Naltrexone and Clonidine Combination|subjects will receive 1 study drug capsule by mouth twice daily for 3 weeks, followed by 1 capsule in the morning for 3 days.
16197336|NCT01415895|Drug|placebo|subjects will receive 1 placebo capsule by mouth twice daily for 3 weeks, followed by 1 capsule in the morning for 3 days.
16197342|NCT01415856|Device|Active Device (Torino II)|Device is giving treatment for 15 minutes every 2 hours for a total of two weeks.
16197343|NCT01415856|Device|Sham Device (Torino II)|Device is designed to appear to be giving treatment when it is not actually giving treatment. Patients will wear this for a duration of two weeks.
16197344|NCT01415830|Biological|Anti-scorpion venom serum Birmex|the dose may be required for the patient according to clinical manifestations and evolution
16197345|NCT01415830|Biological|Anti-scorpion venom serum Alacramyn|The dose may be required fot the patient according to clinical manifestations and evolution
16197346|NCT01415817|Other|Training session|Series of two training sessions after the first phase of study followed by monthly feedback.
16197347|NCT01415804|Device|endoprosthesis|Thoracic aortic stentgraft
16197348|NCT01415791|Drug|ICI176,334-1|Subject will receive single dose of ICI176,334-1
16197349|NCT01415778|Drug|ICI176,334-1|Subject will receive single dose of ICI176,334-1
16199578|NCT01398085|Radiation|I131 1.1 GBq|Radio-iodine
16197351|NCT01415765|Drug|MLN4924|Part A: 150mg/m2 IV (in the vein) on days 1,4,7,11 of each 21 day cycle Part B: variable dose levels IV on days 1,5 each 21 day cycle
16197352|NCT01415765|Drug|Etoposide|CIV(continuous intravenous infusion) on days 1-4 of every 21 day cycle
16197353|NCT01415765|Drug|Prednisone|PO (by mouth) twice daily on days 1-5 of every 21 day cycle
16197354|NCT01415765|Drug|Vincristine|CIV on days 1-4 of every 21 day cycle
16197355|NCT01415765|Drug|Cyclophosphamide|IV on day 5 of each 21 day cycle
16197356|NCT01415765|Drug|Doxorubicin|CIV on days 1-4 of each 21 day cycle
16197357|NCT01415765|Drug|Rituximab|IV on day 1 of each 21 day cycle
16197358|NCT01415765|Drug|Filgrastim|Subcutaneously beginning Day 6 of each 21 day cycle
16197359|NCT01415752|Biological|rituximab|Given IV
16197360|NCT01415752|Drug|bendamustine hydrochloride|Given IV
16197361|NCT01415752|Drug|bortezomib|Given IV or SC
16197362|NCT01415752|Drug|lenalidomide|Given PO
16197363|NCT01415739|Other|laboratory biomarker analysis|Correlative studies
16197364|NCT01415726|Device|Stem Cell Educator|For the treatment, commonly the left (or right) median cubital vein, a patient's blood is passed through a Blood Cell Separator that isolates the lymphocytes from the blood according to the recommended protocol by manufacture; consequently, the collected lymphocytes were transferred into the Stem Cell Educator and treated by CB-SC; after that, the educated cells return the blood back to the patient via a dorsal vein of hand. During the MCS+ collection, the whole blood flow rate was maintained at 35 mL/min. The whole procedure was scheduled for 6 ~ 7 hrs.
16197365|NCT01415713|Drug|S-1,Leucovorin,Oxaliplatin,Gemcitabine|Biweekly S-1, Leucovorin, Oxaliplatin and Gemcitabine (SLOG) in metastatic pancreatic adenocarcinoma
16197366|NCT01415700|Device|Functional electrical stimulator|The stimulator is surgically implanted
16197367|NCT01415700|Device|feet orthosis|feet orthosis specifically mold
16197368|NCT01415687|Drug|Polyethylene Glycol-Based Lavage|"Split dose Polyethylene Glycol-Based Lavage (2L + 2L)
~If arrival for colonoscopy is prior to 10AM: at 12 noon on the day before your colonoscopy drink 2L of PEG within two hours. At 8PM that day, drink the remaining 2L of PEG within two hours.
~If arrival for colonoscopy is at or after 10AM: at 8PM on the day before your colonoscopy, drink 2L of PEG within two hours. Starting five hours before your arrival time at the Centre on the day of your colonoscopy, drink the remaining 2L of PEG within two hours."
16197369|NCT01415687|Drug|Pico-Salax (Magnesium Citrate) plus Bisacodyl|"If arrival for colonoscopy is prior to 10AM: 2 tablets Dulcolax at 8PM three days before colonoscopy, 2 tablets Dulcolax at 8PM two days before colonoscopy, and on the day before colonoscopy at 12 noon, drink the first packet of Pico-Salax in 8oz water, and the second packet of Pico-Salax in 8oz of water at 8PM. Day of colonoscopy, drink clear fluids.
~If arrival for colonoscopy is at or after 10AM: 2 tablets Dulcolax at 8PM three days before colonoscopy, 2 tablets Dulcolax at 8PM two days before colonoscopy, and on the day before colonoscopy at 8PM, drink the first packet of Pico-Salax in 8oz water. Day of colonoscopy, drink the second packet of Pico-Salax in 8oz water five hours before you are to arrive at the Centre."
16197370|NCT01415674|Drug|Afatinib|Afatinib 40mg per os daily for 14 to 28 days, depending on the date of the surgery
16197371|NCT01415661|Other|cricoid pressure|The current study test by direct visual evidence the occlusion of esophageal entrance during application CP. The closure of the lumen was further demonstrated by the inability to introduce a GT into the esophagus during CP.
16197372|NCT01415648|Other|cerebral oximetry monitoring using INVOS™ and hemodynamic optimisation|continuous per operative cerebral oximetry monitoring associated with hemodynamic optimisation algorithm (excluding norepinephrine) if cerebral oximetry decrease more than 15% under the preoperative baseline
16197373|NCT01415648|Other|standard cerebral monitoring and hemodynamic optimisation|the patient is continously monitored with cerebral oximeter but this latter is blinded to the medical team, the alarm switch off , and patients are managed with the standard care of the centre.
16197374|NCT01415635|Dietary Supplement|Nutritional intervention using|"The study is af 12 week randomized clinical trail with inclusion of 96 patients at nutritional risk, according to the NRS-2002 system. The intervention group is is given a tailored nutritional care(the possibility to order small energy and protein-enriched dishes called Delights of Herlev Hospital)."
16197375|NCT01415622|Device|PlasmaDerm|plasma treatment 3 times a week for 8 weeks, 45 sec / cm² of Ulcus cruris size, in addition to standard care.
16197376|NCT01415622|Procedure|standard care of Ulcera crurum|standard care of Ulcera crurum: Mepithel gaze for non-exsudative wounds, Mepilex for exsudative wounds, followed by surgical hose treatment. Additionally, a standardized compression therapy with Ulcer X is applied.
16197377|NCT01415596|Drug|salbutamol|
16197378|NCT01415596|Drug|Placebo|
16197379|NCT01415583|Drug|Dexamethasone|0.5mg/kg (max dose 20mg)
16197380|NCT01415557|Other|Non-Fortified Control Product|Non-Fortified Control Beverage
16197381|NCT01415557|Other|Micronutrient Fortified Test Product|Micronutrient Fortified Test Beverage
16197382|NCT01415531|Drug|Nebivolol|Nebivolol (non-trade 5, 10 or 20 mg tablet), oral administration
16197383|NCT01415531|Drug|Placebo|Dose-match placebo
16197384|NCT01415518|Drug|Drug: Budesonide/formoterol (Symbicort Turbuhaler|budesonide/formoterol (Symbicort Turbuhaler 160/4.5µg/inhalation, 2 inhalations twice daily)
16197385|NCT01415518|Drug|Drug: ipratropium (AtroventTM)|ipratropium (AtroventTM 20 µg/inhalation, 2 inhalations four times daily)
16197386|NCT01415518|Drug|theophylline SR|theophylline SR (0.1g/tablet, 1 tablet p.o. twice daily)
16197387|NCT01415505|Drug|Nebivolol, Valsartan and Hydrochlorothiazide|Nebivolol 5 mg (tablet), oral administration Nebivolol 10 mg (tablet), oral administration Nebivolol 20 mg (tablet), oral administration Valsartan 160 mg (tablet), oral administration Valsartan 320 mg (tablet), oral administration Hydrochlorothiazide 12.5 mg rescue medication (capsules), oral administration. Hydrochlorothiazide 25 mg rescue medication (capsules), oral administration
16197388|NCT01415492|Behavioral|HD2|The intervention was delivered via either print materials or access to a HD2 Web Site. ADDITIONAL NOTE: A sub-set of these participants was randomly selected to receive the Electronic Reminders through the intervention. Those who were selected could choose to receive the Electronic Reminders either as text messages or as automated phone reminders.
16197423|NCT01415141|Drug|Ribavirin|"Administered orally twice a day as follows:
~weight < 75kg - 1000mg weight ≥ 75kg - 1200mg"
16197424|NCT01415141|Drug|telaprevir|750mg every 8 hours, orally
16197389|NCT01415492|Behavioral|HD2+|The intervention was delivered via either print materials or access to a HD2 Web Site. In addition participants received two coaching calls from Health Coaches. ADDITIONAL NOTE: as noted above, a sub-set of these participants was randomly selected to receive the Electronic Reminders through the intervention. Those who were selected could choose to receive the Electronic Reminders either as text messages or as automated phone reminders.
16197390|NCT01415479|Behavioral|Control|Computer-based presentation regarding colorectal cancer (CRC) and screening for CRC with colonoscopy, sigmoidoscopy, or stool testing. Includes a video from the American Cancer Society.
16197391|NCT01415479|Behavioral|Quantitative|Computer-based presentation providing quantitative information regarding (a) the lifetime average probability of getting CRC or dying from it, (b) the reduction in mortality provided by undergoing regular screening with colonoscopy, and (c) the reduction in mortality provided by undergoing regular screening with fecal immunochemical testing (FIT)
16197392|NCT01415479|Behavioral|Default|"Computer-based presentation that encourages subjects who are unwilling to undergo colonoscopy or are unsure about whether to undergo screening to get tested with Fecal Immunochemical Testing (FIT). This is labeled the Default intervention since it attempts to shift the default choice from no screening to FIT."
16197393|NCT01415466|Drug|Cresto|tablet, 20mg
16197394|NCT01415466|Drug|Olmetec|tablet, 40mg
16197395|NCT01415466|Drug|Cresto, Olmetec|tablet, 20mg and 40mg
16197396|NCT01415453|Procedure|Ultrasound Stimulus|Short pulses of focused ultrasound will be directed at spots on the retinal surface.
16197397|NCT01415440|Drug|Lisdexamfetamine|During the first 4 weeks of treatment, the dosage of Lisdexamfetamine will be adjusted based on the patient's response to the medication. The patient will then be maintained at the lowest effective dose for the remaining 8 weeks of treatment.
16197398|NCT01415440|Drug|Placebo|Placebo dosing will parallel that of Lisdexamfetamine.
16197399|NCT01415427|Drug|BMN 110 - Weekly|"In Part 1, patients will receive intravenous (IV) infusions of study drug at a dose of 2.0 mg/kg/qw administered over a period of approximately 4 hours once a week.
~In Part 2, patients will continue to receive 2.0 mg/kg of BMN 110 every week, with no placebo."
16197400|NCT01415427|Drug|BMN 110 - Every Other Week|"In Part 1, patients will receive intravenous (IV) infusions of study drug at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week. Patients randomized to the 2.0 mg/kg/qow arm will receive infusions of placebo on alternating weeks, to mask active drug weeks.
~In Part 2, patients will receive 2.0 mg/kg of BMN 110 every week, with no placebo."
16197401|NCT01415414|Drug|Iopromide (Ultravist, BAY86-4877)|CT enhancement for abdominal or pelvic scan. Generally doses of up to 1.5 g iodine per kg body weight are well tolerated
16197402|NCT01415401|Drug|Brinzolamide 1% / timolol 0.5% maleate fixed combination|
16197403|NCT01415388|Dietary Supplement|Krill Oil|4 Capsules twice daily providing 0 (placebo), 0.5, 1.0, 2.0, or 4.0 g krill oil/day for a period of 12 weeks
16197404|NCT01415375|Behavioral|Prostate Cancer Screening Education|tailored telephone education on prostate cancer testing
16197405|NCT01415375|Behavioral|Fruit and Vegetable Intake Education|tailored telephone education about fruit and vegetable consumption
16197406|NCT01415362|Device|Transcranial Direct Current Stimulation|"For both active and sham tDCS, the device will be hooked up to the closed loop system, using electrodes of 35cm^2. During active tDCS, the subject will receive 2mA for 5 min. During sham tDCS, the current will only be active for 30 seconds (current ramping up and then down) to simulate the sensations of active tDCS.
~The subject will undergo either active or sham stimulation for their first 24-hour EEG monitoring visit, and the opposite intervention on the second 24-hour EEG monitoring visit."
16197407|NCT01415349|Drug|SSP-002358|1 mg, oral, once
16197408|NCT01415349|Drug|SSP-002358 + omeprazole|SSP-002358 (1 mg) + omeprazole (40 mg) given orally, once
16197409|NCT01415336|Drug|Doxorubicin, Cyclophosphamide|doxorubicin 60 mg/m², iv, day 1; Cyclophosphamide 600 mg/m², iv, day 1; every 3 weeks for 4 cycles
16197410|NCT01415336|Drug|doxorubicin, Capecitabine|doxorubicin 60 mg/m², iv, day 1; capecitabine 950 mg/m2, twice a day, via oral intake, day 1 to day 14; every 3 weeks for 4 cycles
16197411|NCT01415297|Drug|NKP-1339|NKP-1339 is administered as a 30-90 minute IV infusion (based on volume to be infused) on days 1, 8, and 15 of a 28 day cycle.
16197412|NCT01415284|Drug|Hydroxyethylstarch 130/0.4|first patient : 500 mL. Following volumes according to up-down sequential allocation, with increments or decrements of 100 mL. An absence of hypotension will lead to an decrement while a presence of hypotension will result in an increment.
16197413|NCT01415271|Other|Internet Communication|bi-weekly communication of blood sugars using an internet platform between patients with type 2 diabetes and an endocrinologist
16197414|NCT01415245|Device|Fluent (VGS Fluent external support device)|Fluent external support device applied to saphenous vein graft
16197415|NCT01415232|Device|Sonosite S-Nerve® US system (SonoSite, Bothell,WA)|Ultrasound to measure depth to the epidural space in morbidly obese parturients
16197416|NCT01415219|Other|Active rehabilitation|A program of 12 individual exercise sessions (3 per week during 4 weeks)
16197417|NCT01415206|Behavioral|Extended Staging Health Risk Intervention (S-HRI)|The S-HRI provides feedback on participants' stages of change for each risk and the single most important step they can take to begin progressing. A counselor will review the report with participants and provide motivational interviewing (MI) coaching and referrals to relevant behavior change services. Repeated computer and individual counseling contacts at baseline, 3, 6 and 12 months follow-up are designed to support participants through the process of changing multiple risk behaviors.
16197418|NCT01415206|Behavioral|Usual Care|Participants in the usual care condition will complete the core assessments and the S-HRA online at baseline, 3, 6, 12,and 18 months follow-up but will not meet with the study MI coach and will NOT receive any feedback or printed report until the 18-month follow-up.
16197419|NCT01415193|Procedure|Selective Tibial Nerve block|Use of selective pain block.
16197420|NCT01415193|Procedure|Sciatic Nerve Block|Use of Sciatic Nerve Block
16197421|NCT01415154|Device|NeuroStar TMS|NeuroStar TMS treatmant - 120% of Observed MT, 10 pulses per second, 4 second on-time, 26 second off-time, 75 trains, 3,000 total pulses/sessions for 6 days. 3 treatments in taper week 1, 2 treatments in taper week 2 and 1 treatment in taper week 3.
16197422|NCT01415141|Drug|Peginterferon alfa-2a|180ug subcutaneously, weekly
16197509|NCT01414595|Other|laboratory biomarker analysis|
16197425|NCT01415128|Drug|Omeprazole|Once a day dosing of Omeprazole (40 mg) for 8 days
16197426|NCT01415128|Drug|Rosiglitazone|Single dose of Rosiglitazone (8 mg) for 1 day
16197427|NCT01415128|Drug|Desipramine|Single dose of Desipramine (50 mg) for 1 day
16197428|NCT01415102|Drug|PF-05212372|Inhaled. Dose Level 1: 50 ug
16197429|NCT01415102|Drug|PF-05212372|Inhaled. Dose Level 2 - Dose to be selected based upon safety/tolerability/PK at preceding dose
16197430|NCT01415102|Drug|PF-05212372|Inhaled. Dose Level 3 - Dose to be selected based upon safety/tolerability/PK at preceding dose
16197431|NCT01415102|Drug|PF-05212372|Inhaled. Dose Level 4 - Dose to be selected based upon safety/tolerability/PK at preceding dose
16197432|NCT01415102|Drug|Placebo|Inhaled
16197433|NCT01415102|Drug|PF-05212372|Inhaled. Dose Level 5 - Dose to be selected based upon safety/tolerability/PK at preceding dose
16197434|NCT01415102|Drug|PF-05212372|Inhaled. Dose Level 6 - Dose to be selected based upon safety/tolerability/PK at preceding dose
16197435|NCT01415102|Drug|PF-05212372|Inhaled. Dose Level 7 - Dose to be selected based upon safety/tolerability/PK at preceding dose
16197436|NCT01415102|Drug|Placebo|Inhaled
16197437|NCT01415089|Behavioral|FOCUS-Web|A 3-session individually tailored, interactive, web-based program providing support and education for cancer patients and one of their family caregivers.
16197438|NCT01415076|Procedure|Insufflation with CO2|Patients were randomly allocated to receive whole procedure or extubation-only CO2 insufflation, using a randomized computer-generated list.
16197439|NCT01415063|Procedure|RFA|For RFA, we used a commercially available system with a 375-KHz computer-assisted radiofrequency generator (Elektrotom HiTT 106, Berchtold, Medizinelektronik, Germany) and an open-perfused electrode (Berchtold, Tuttlingen, Germany) of 15 cm (or 20 cm), 14 Ga, and a 15 mm (or 20 mm) active electrode tip with microbores.
16197440|NCT01415063|Procedure|TACE-RFA|TACE first, then RFA within 2 weeks
16197441|NCT01415050|Device|Whole body vibration|15 times WBV
16197442|NCT01415037|Procedure|annular array ultrasound exam|For this research study you will be asked to sit in a chair. You will be given 2 drops of a numbing solution. The ultrasound camera will be enclosed in a sterile membrane and will be placed gently upon your eye. You may be asked to gaze at a light source while measurements are being made. The procedure will last about 10-15 minutes from start to finish.
16197443|NCT01415024|Procedure|second LV lead in CRT|second LV lead in CRT
16197444|NCT01415011|Drug|Afatinib (BIBW 2992)|All patients will be given daily oral afatinib (BIBW 2992) administered every 28 days until disease progression/toxicity/clinician decision to stop. Starting dose is 40mg. 30mg and 20mg will be administered according to protocol dose modification requirements following toxicity.
16197445|NCT01414998|Behavioral|Stress Ball vs Nicotine-free E-Cigarette|"In a cross over design, participants will be randomly allocated to:
~use a stress ball for 5 minutes during a 1 hour controlled experiment. They will also use the stress ball for one day outside of the study centre.
~use a nicotine-free EC for 5 minutes during a 1 hour controlled experiment. They will also use the EC ad-libitum for one day outside of the study centre.
~One week later participants will complete the other arm."
16197446|NCT01414998|Behavioral|Nicotine-free E-Cigarette vs De-nicotinised Cigarette|"In a cross over design, participants will be randomly allocated to:
~use a nicotine-free EC for 5 minutes during a 1 hour controlled experiment. They will also use the EC ad-libitum for one day outside of the study centre.
~smoke 1 de-nicotinised cigarette during a 1 hour controlled experiment. They will also be given a pack to smoke ad-libitum for one day outside of the study centre.
~One week later participants will complete the other arm."
16197447|NCT01414985|Biological|AAVrh.10CUCLN2|There will be 2 dose cohorts in this study. Group A consists of 2 subjects who have received 9.0x10^11 genome copies (900,000,000,000 molecules) of the study drug, AAVrh.10CUCLN2. Group B will consist of 6 subjects who will receive a lower dose of 2.85x10^11 genome copies (285,000,000,000 molecules) of the study drug, AAVrh.10CUCLN2.
16197448|NCT01414972|Drug|Vitamin A|1 cap vitamin A 25000 IU/day for 3 month
16197449|NCT01414972|Drug|placebo|1 cap placebo/day for 3 month
16197450|NCT01414946|Other|Intravenous nutrition with glucose and amino acids|Glucose and amino acids intravenously starting 20 hours before the operation until the second postoperative day. Glucose provides 50% and amino acids 20% of each patient's measured resting energy expenditure.
16197451|NCT01414946|Other|Intravenous nutrition with amino acids|Amino acids intravenously starting 20 hours before the operation until the second postoperative day. Amino acids providing 20% of each patient's measured resting energy expenditure.
16197452|NCT01414933|Other|Biopsy|Breast metastases biopsy
16197453|NCT01414920|Drug|Placebo|TAK-875 and sitagliptin placebo-matching tablets, orally, once daily for up to 12 weeks.
16197454|NCT01414920|Drug|TAK-875|TAK-875 25 mg, tablets, orally, once daily for up to 12 weeks.
16197455|NCT01414920|Drug|TAK-875|TAK-875 50 mg, tablets, orally, once daily for up to 12 weeks.
16197456|NCT01414920|Drug|Sitagliptin|Sitagliptin 100 mg, tablets, orally, once daily for up to 12 weeks.
16197457|NCT01414920|Drug|TAK-875 and Sitagliptin|TAK-875 25 mg, tablets, orally, once daily and sitagliptin 100 mg tablets, orally, once daily for up to 12 weeks.
16197458|NCT01414920|Drug|TAK-875 and Sitagliptin|TAK-875 50 mg, tablets, orally, once daily and sitagliptin 100 mg tablets, orally, once daily for up to 12 weeks.
16197459|NCT01414907|Behavioral|Health promotion activities|Counselled activities on tobacco smoking secession, diet correlation and physical activities
16197460|NCT01414894|Other|Fluid manipulation|Patients are treated with conventional fluid replacement (Normovolemia) or increased the fluid replacement (Hypervolemia) for 10 days.
16197461|NCT01414894|Other|Blood Pressure Manipulation|Patients are treated with maintenance of blood pressure in a normal range (Conventional Blood Pressure) or increased the blood pressure (Augmented Blood Pressure) for 10 days.
16197462|NCT01414881|Drug|mipomersen|mipomersen 200mg subcutaneously (SC) once weekly
16197463|NCT01414881|Drug|Placebo|Placebo administered subcutaneously (SC) once weekly
16197464|NCT01414868|Drug|leukotriene receptor antagonist (montelukast)|montelukast (10 mg, once per night)
16197465|NCT01414855|Drug|obinutuzumab|1000 mg intravenously on Day 1 of each 21-day cycle, 8 cycles; during Cycle 1 administration also on Days 8 and 15.
16197466|NCT01414855|Drug|cyclophosphamide|750 mg/m^2 intravenous (IV), Day 1 of each 21-day cycle, 6 cycles.
16197467|NCT01414855|Drug|doxorubicin|50 mg/m^2 IV, Day 1 of each 21-cycle, 6 cycles.
16197468|NCT01414855|Drug|prednisone|100 mg/day, Days 1 through 5 of each 21-day cycle, 6 cycles.
16197469|NCT01414855|Drug|vincristine|1.4 mg/m^2 IV, Day 1 of each 21-day cycle, 6 cycles.
16197470|NCT01414842|Device|Automated sodium profiling in endogenous hemodiafiltration|Automated sodium profiling during endogenous reinfusion hemodiafiltration technique. The device processes the dialysate sodium and ultrafiltration rate during dialysis to achieve a preset sodium target at the end of the treatment. Sodium dialysate and maximal ultrafiltration rate are constraint within safety limits during dialysis.
16197471|NCT01414842|Device|Standard sodium dialysate|Standard constant (no profiled) sodium dialysate used during endogenous hemodiafiltration
16197472|NCT01414829|Procedure|Gastroscopy|The reason for gastroscopy will be not related to the study
16197473|NCT01414816|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|EOD, dosage frequency and duration will be decide by physicians.
16197474|NCT01414803|Drug|Lipid modification|rosuvastatin 10 mg/fenofibrate 160 mg per day
16197475|NCT01414803|Drug|Lipid modification|rosuvastatin 10 mg per day
16197476|NCT01414790|Procedure|ADM|29 patients (ADM group) had a total parotidectomy with a simultaneous ADM implantation
16197477|NCT01414777|Drug|ondansetron|Ondansetron 8mg IV or placebo will be administered prior to placement of the spinal anesthetic
16197478|NCT01414777|Drug|placebo|placebo or ondansetron 8mg IV will be administered prior to placement of the spinal anesthetic
16197479|NCT01414764|Other|Autologous conditioned plasma (ACP)|"10ml of patient's own venous blood is aspirated. ACP (1ml) (extracted from centrifuged venous sample), with additional calcium chloride is then injected into the tendon-bone junction and adjacent area under guided ultrasound.
~First injection at approximately 10 days post-operatively
~Second Injection at approximately 21 days post-operatively"
16197480|NCT01414764|Drug|Placebo|"10ml of patient's own venous blood is aspirated. The syringe is centrifuged in a proprietary closed unit (Arthrex Medical Company) for 5 minutes. The venous blood sample will be discarded and a placebo (1ml saline + local anaesthetic) is injected to the surrounding tissue, but not into the tendon, under guided ultrasound.
~First injection at approximately 10 days post-operatively
~Second Injection at approximately 21 days post-operatively"
16197481|NCT01414751|Behavioral|Absolute risk reduction|Patients receive effectiveness information concerning cholesterol lowering therapy by means of absolute risk reduction
16197482|NCT01414751|Behavioral|Prolongation of life|Patients receive effectiveness information concerning cholesterol lowering therapy by means of prolongation of life/life extension.
16197483|NCT01414738|Radiation|Radiotherapy|Hippocampal-Avoiding Whole Brain Irradiation with Simultaneous Integrated Boost
16197484|NCT01414725|Other|Standard Physiotherapy Exercises|Individualised face to face training sessions, delivered over 12 weeks, plus an individualised 15-minute daily home exercise programme will be provided. This will be undertaken by a neurological physiotherapist. The exercises will comprise a standardised programme of simple physiotherapy exercises which aim to improve trunk and pelvic stability, lower limb muscle length and strength, and balance and control of movement, as described by Barrett et al [2009]. Exercises will be progressed in response to the abilities of the individual. Each participant will receive a workbook with written and diagrammatic instructions describing their home exercise programme.
16197485|NCT01414725|Other|Core Stability Training|Individualised face to face training sessions, delivered over 12 weeks, plus an individualised 15-minute daily home exercise programme will be provided. This will be undertaken by a neurological physiotherapist with experience in the delivery of core stability training to people with MS. Exercises will be progressed in response to the abilities of the individual. Each participant will receive a workbook with written and diagrammatic instructions describing their home exercise programme.
16197486|NCT01414725|Other|Relaxation|Three face to face individualised relaxation sessions, provided at 4 weekly intervals, plus a 15-minute home programme based around an audio relaxation CD. Weekly telephone contact / support will be provided.
16197487|NCT01414712|Other|Blood Drawing|Blood Drawing to measure circulating tumor cells counts.
16197488|NCT01414699|Behavioral|Variety|These conditions will have snack served with an increase of fruit variety.
16197489|NCT01414699|Behavioral|Non-Variety|These conditions will receive a snack without a variety of fruit.
16197490|NCT01414686|Other|Commercially-Available Interactive Video Games|"Two commercially available gaming platforms were used in this study, the Nintendo Wii and the Sony PS 2. The Wii games included Wii Sports and Wii Fit; PS games included the EyeToy Play 2 and Kinetic. Each of these games provides multiple mini games which pose different movement challenges, including dynamic balance, speed, accuracy, general mobility, and weight shifts.
~Game play was performed 1 hour/day, 4 days/ week, for a period of 5 weeks, totaling 20 hours."
16197491|NCT01414673|Drug|HCG|5000 IU
16197492|NCT01414660|Procedure|transplantation|transplantation of islet, kidney or liver
16197493|NCT01414647|Dietary Supplement|300 g of strawberry, raspberry and cloudberry|100 g of strawberry puree, 100 g of frozen raspberries and 100 g frozen cloudberries were concumed daily for 8 weeks. Bilberry consumption was restricted.
16197494|NCT01414647|Dietary Supplement|400 g of bilberry|Equivalent amount to 400 g of fresh bilberries were consumed as 40 g of dried bilberries and as 200 g of frozen bilberries. Restriction of use of strawberries, raspberries and cloudberries were set.
16197495|NCT01414647|Other|Control diet|Control diet, ie. habitual diet with restriction of berry consumption was consumed for eight weeks
16197496|NCT01414634|Biological|ETIMS|injection of peptide-coupled PBMC by i.v. infusion
16197497|NCT01414621|Other|atrial tissue sample|atrial tissue sample from CABG patient
16197498|NCT01414608|Radiation|Brachytherapy|Undergo brachytherapy
16197499|NCT01414608|Drug|Carboplatin|Given IV
16197500|NCT01414608|Drug|Cisplatin|Given IV
16197501|NCT01414608|Radiation|External Beam Radiation Therapy|Undergo external beam radiation therapy
16197502|NCT01414608|Drug|Paclitaxel|Given IV
16197503|NCT01414608|Other|Quality-of-Life Assessment|Ancillary studies
16197504|NCT01414595|Genetic|DNA analysis|
16197505|NCT01414595|Genetic|DNA methylation analysis|
16197506|NCT01414595|Genetic|RNA analysis|
16197507|NCT01414595|Genetic|gene expression analysis|
16197508|NCT01414595|Genetic|polymorphism analysis|
16197511|NCT01414582|Device|Anodal tDCS|Participants will receive anodal tDCS over the primary motor cortex of the ipsilesional hemisphere. The following parameters will be used: stimulation intensity of 1mA for the first 20 minutes of motor training (9 consecutive sessions Monday-Friday).
16197512|NCT01414582|Other|Motor Training|All participants will receive a standardised motor training intervention for the upper paretic limb
16197513|NCT01414569|Drug|Dexamethasone|Singe dose preoperatively in 100 ml saline intravenously
16197514|NCT01414556|Other|Glucose-dependent Insulinotropic polypeptide|infusion 4 pmol x kg x min first 15 min, thereafter 2 pmol x kg x min
16197515|NCT01414556|Other|saline|
16197516|NCT01414543|Other|Information Sheet|Providing the Participant with information regarding the aim of the experiment
16197517|NCT01414543|Other|Consent|Providing a consent form for participants. The participant is aware of his or her rights
16197518|NCT01414543|Other|interview|participants will interviewed by fardin jussab for approximately one hour regarding their experience of client violence
16197519|NCT01414543|Other|Debrief|at the end of each interview the researcher will ask participants whether the emotions aroused in the interview require further discussions. Interviewees will be also advised that should they wish to talk further about any topics covered the in the interview, they could telephone the researcher at a later time. There will also be leaflets of supporting agencies.
16197520|NCT01414530|Drug|oral contraceptive|ethinyl estradiol 0.03mg/levonorgestrel 0.15mg daily for 8 weeks
16197521|NCT01414530|Drug|NSAID|ibuprofen 200mg/arginine 185mg twice per day for 8 weeks
16197522|NCT01414517|Dietary Supplement|FructoOligoSaccharide|A mixture of 70% oligofructose and 30% inulin.
16197523|NCT01414517|Dietary Supplement|Maltodextrin|a non-prebiotic carbohydrate
16197524|NCT01414504|Biological|Prevenar + PPV|0.5mL dose of Prevenar at 0-1-2 months, 0.5mL Pneumovax at 9 months and 0.1mL Pneumovax at 3-5 yrs
16197525|NCT01414504|Biological|Infant PCV (Prevenar) + PPV at 9 months|0.5mL Prevenar at 1-2-3 months,0.5mL Pneumovax (PPV) at 9 months, 0.1mL Pneumovax at 3-5 yrs
16197526|NCT01414504|Biological|No Prevenar + PPV at 9 months|no Prevenar, 0.5mL Pneumovax at 9 months, 0.1mL Pneumovax at 3-5 yrs
16197527|NCT01414504|Biological|Control|control, 0.1mL Pneumovax at 3-5yrs
16197528|NCT01414478|Other|Protein Shake|Protein shake contains 30 grams of protein in 11 fluid ounces.
16197529|NCT01414465|Drug|Orlistat|Obese women were treated with orlistat 120mg 3 times a day for 4 months, compared with basal data and with normal weight women that didn´t receive orlistat
16197530|NCT01414439|Behavioral|Existential Group Therapy|The treatment will be given in two groups of eight to ten participants each one and will consist of one hour weekly sessions over a period of seven weeks. Dividing the subjects into small groups allows reference to all members of the group. The group facilitators will be two psychologists who work in co therapy.
16197531|NCT01414426|Drug|vandetanib|Given PO
16197532|NCT01414426|Other|placebo|Given PO
16197533|NCT01414426|Other|immunohistochemistry staining method|Correlative studies
16197534|NCT01414426|Other|laboratory biomarker analysis|Correlative studies
16197535|NCT01414426|Procedure|biopsy|Correlative studies
16197536|NCT01414426|Other|pharmacological study|Correlative studies
16197537|NCT01414413|Other|Home assessment and initiation of ART|Home-based ART eligibility assessment (WHO staging, CD4 count measurement and educational treatment preparation) and initiation.
16197538|NCT01414413|Other|Clinic-based ART assessment and initiation|Participants who meet eligibility criteria and reside in a cluster that has been allocated to the control arm of this study will receive supported access to ART care through the primary care system for confirmation of HIV status and entry into HIV following disclosure to the resident community counsellor.
16197539|NCT01414400|Other|Blood draw for culture|Blood will be drawn and sent for culture.
16197540|NCT01414387|Procedure|Carotid filter|"Patients randomized to this group will receive filter devices to prevent cerebral embolization during carotid stenting, assessed by intraoperative transcranial Doppler and postoperative cerebral DW-MRI.
~The filter used for this trial is the RX accunet embolic protection system manufactured by abbott."
16197541|NCT01414387|Procedure|Carotid reversal of flow|On the flow reversal arm two type of devices will be used. The first is the Gore flow reversal system, manufactured by LW Gore and the second device is the IVANTEC MoMa Ultra Embolic protection device, manufatured by IVANTEC.
16197542|NCT01414374|Drug|Herbal medicine|Patients will receive a combination of Hibiscus sabdariffa (powdered dry plant), 200 mg, BID, and Centella asiatica tincture, 40 drops, BID, for 6 weeks.
16197543|NCT01414374|Drug|Iron|Patients will receive iron sulphate, 500 mg, BID, plus orange juice, for 6 weeks.
16197544|NCT01414348|Behavioral|Conventional rehabilitation.|1 hour / 2x / week for up to 15 sessions
16197545|NCT01414348|Behavioral|Novel rehabilitation approach|1 hr, 2x/week for up to 15 sessions
16197546|NCT01414335|Dietary Supplement|amino acid composition|one single pouch (13g) of amino acid mixture and vitamins diluted into 200 ml of still water. This solution was daily oral taken after a meal.
16197547|NCT01414335|Other|Placebo|placebo contained no amino acids and vitamins and was identical in appearance and solution properties.
16197548|NCT01414296|Drug|PSMA ADC|PSMA ADC administered IV
16197549|NCT01414283|Drug|PSMA ADC|PSMA ADC administered IV
16197550|NCT01414257|Drug|Methotrexate (MTX)|Methotrexate should be administered at the weekly dose of 6 mg orally once a week or twice or three times a week by subdividing the weekly dose into the relevant number of portions. When administering the subdivided doses, MTX should be administered at the interval of 12 hours on Day 1 to Day 2. When the weekly dose is subdivided into two portions, suspend the administration for the remaining 6 days. When the weekly dose is subdivided into three portions, suspend the administration on the remaining 5 days. Repeat this weekly cycle. The dose should be adjusted as appropriate depending on the age, symptom, tolerability, and response to the MTX Preparation in individual patients. The weekly dose should not be higher than 16 mg.
16197551|NCT01414244|Drug|Glutamine|Drug
16197552|NCT01414231|Drug|Cytarabine|Intermediate dose against low dose; IDA 12 mg/m2 iv days 1 - 3 and AraC 2 x 1 g/m2 bid on days 1+3+5+7 vs. AraC 100 mg/m2/day i.v.-for 7 days and Daunorubicin 60 mg/m2/Tag on days 3, 4 und 5.
16197641|NCT01413529|Behavioral|adherence counseling with the addition of smartphone control|Participants will receive adherence counseling with the addition of smartphone control.
16197553|NCT01414218|Behavioral|Humor as a Way of Life Seminar|One session per week lasting 2-3 hours per session for 4 months. Sessions will include the videotaping of humorous stories or situations and instruction related to strategies to incorporate humor into everyday life.
16197554|NCT01414205|Drug|Obinutuzumab|Participants were administered obinutuzumab either at 1000 mg or 2000 mg on Day 1, 8, 15 of Cycle 1 and then on Day 1 of each 21 day cycles for up to 8 cycles.
16197555|NCT01414205|Drug|Corticosteroids|Participants were administered corticosteroids IV prior to the initial dose.
16197556|NCT01414166|Drug|ERN/LRPT|ERN/LRPT combination tablets (each containing 1 g of extended release niacin and 20 mg of laropiprant), orally, one tablet once per day for 4 weeks, then 2 tablets once per day for 12 weeks
16197557|NCT01414166|Drug|placebo|ERN/LRPT-matched placebo, orally, one tablet once per day for 4 weeks, then 2 tablets once per day for 12 weeks
16197558|NCT01414153|Drug|4.0 mg iSONEP|4.0 mg iSONEP given monthly intravitreously for 4 months
16197559|NCT01414153|Drug|0.5 mg iSONEP|0.5 mg iSONEP given monthly intravitreously for 4 months
16197560|NCT01414153|Drug|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea|0.5 mg Lucentis or 1.25 mg Avastin or 2 mg Eylea given monthly intravitreously for 4 months
16197561|NCT01414153|Drug|sham injection|administered monthly for 4 months
16197562|NCT01414140|Drug|Levonorgestrel IUS (Mirena, BAY86-5028)|Women inserted Mirena for intrauterine contraception.
16197563|NCT01414114|Drug|Etelcalcetide|Administered 3 times a week by bolus injection into the venous line of the dialysis circuit after the end of hemodialysis.
16197564|NCT01414101|Drug|ISIS CRP Rx or Placebo|
16197565|NCT01414088|Other|isotonic saline 0,9 mg/ml|infusion, 23 ml/kg, during 50 minutes
16197566|NCT01414088|Other|hypertonic saline 2,9 mg/ml|infusion, 7 ml/kg, during 50 minutes
16197567|NCT01414088|Other|glucose 5%|infusion, 23 ml/kg, during 50 minutes
16197568|NCT01414075|Drug|Roxadustat|Tiered, weight-based dosing per schedule specified in the arm.
16197569|NCT01414075|Drug|Oral Iron|Administered per oral dose and schedule specified in the arm.
16197570|NCT01414075|Drug|IV Iron|Administered per IV dose and schedule specified in the arm.
16197571|NCT01414062|Behavioral|Cocinar Para Su Salud Program|A series of 9 Cocinar Para Su Salud intervention sessions held over a 12-week period. The 12-week intervention period will be divided into 3 groups: motivation, action, and environment. Each topic will use a nutrition roundtable, food shopping field trip, and a cooking class to teach pertinent points, in order to enable participants to progress from the precontemplation, contemplation, and preparation stages of change to the action and maintenance stages.
16197572|NCT01414062|Behavioral|Written dietary recommendations|Standard of care: one on one meetings with study staff to receive compiled written information on dietary recommendations for breast cancer survivors produced by the NYC-based not-for-profit, God's Love We Deliver
16197573|NCT01414049|Procedure|On-pump CABG|Use of cardiopulmonary bypass (CPB) with cardioplegic arrest: on-pump CABG.
16197574|NCT01414049|Procedure|Off-pump CABG|CABG performed without the use of cardiopulmonary bypass (CPB) with cardioplegic arrest, surgery performed with the beating heart.
16197575|NCT01414036|Other|Enhanced Traditional Care control|Educational brochure, list of hospital and community resources
16197576|NCT01414036|Behavioral|Patient navigation|Patients will receive up to 4 hours of patient navigation, in person or over the phone, over a 3-month period.
16197577|NCT01414023|Behavioral|Cognitive Control Training|Pace Auditory Serial Addition Task (PASAT;(Gronwall, 1977): A computer version of the PASAT will be used to measure sustained attention and working memory. Participants are asked to add serially presented numbers. Attention Control Intervention (Wells, 2000): This task involves training individuals to attend differentially to multiple auditory sources (e.g., by counting tones, discriminating the location of tones, and moving their attention between auditory sources for a prolonged period).
16197578|NCT01414023|Behavioral|Peripheral Vision Task|Peripheral Vision Task (PVT; C. Moore, personal communication): This task serves as a non-active control condition which does not target the brain regions influenced by the Wells and PASAT tasks. Participants focus on the placement of dots on a computer screen in this task while listening to a tone.
16197579|NCT01414010|Dietary Supplement|Trametes versicolor extract|1,200 mg, 3 times daily on an empty stomach for 14 days
16197580|NCT01414010|Dietary Supplement|Saccharomyces boulardii|250 mg, 3 times daily on an empty stomach for 14 days
16197581|NCT01414010|Drug|Amoxicillin|250 mg 3 times daily at least 1 hour before meals for 7 days
16197582|NCT01413984|Behavioral|Helping Women Recover/Beyond Trauma|Four treatment rounds will be conducted, and a goal of 20 women (10 from each group) will be recruited to participate in each round. A new treatment group will start every four months. Sessions are approximately 2 hours each, 3-4 times per week over four months in a group format. This treatment program will focus on the integrated treatment of trauma and substance abuse in women. Versions of the curriculum exist both for community and corrections populations. In this intervention the corrections version will be used.
16197583|NCT01413958|Drug|Phenylephrine|Phenylephrine hydrochloride 30-mg extended-release tablets, one tablet every 12 hours for 7 days
16197584|NCT01413958|Drug|Placebo|Placebo to phenylephrine hydrochloride 30-mg extended release tablets, one tablet every 12 hours for 7 days
16197585|NCT01413958|Drug|Loratadine|Loratadine, 10 mg, once daily as rescue medication, only if needed for intolerable allergic rhinitis symptoms
16197586|NCT01413932|Drug|HT-2157|QD oral dosing
16197587|NCT01413932|Drug|Placebo|QD oral dosing
16197588|NCT01413906|Drug|BMS-833923 (XL139)|Capsule, Oral, 150 mg, 300 mg, or 450 mg,Once daily, Until progression of disease, unacceptable toxicity, withdrawal of subject's consent or meeting other discontinuation criteria
16197589|NCT01413893|Drug|linifanib|QD daily
16197590|NCT01413867|Procedure|stapled hemorrhoidopexy|stapled hemorrhoidopexy will be performed using the EEA stapler Covidien
16197591|NCT01413867|Procedure|stapled hemorrhoidopexy|stapled hemorrhoidopexy will be performed using the PPH01/03 Ethicon EndoSurgery
16197592|NCT01413854|Drug|sugar pill|One tablet two times daily during four weeks
16197593|NCT01413854|Drug|Diclofenac|50 mg, two times daily (oral adm.) during four weeks
16197594|NCT01413841|Drug|Nasal oxygen|3 l oxygen
16197595|NCT01413841|Drug|Regular nasal air|3 l nasal air
16197690|NCT01413100|Other|Questionnaire Administration|Ancillary studies
16197596|NCT01413828|Drug|concurrent|Trastuzumab will be administered concurrently with any anthracycline-containing regimen for breast cancer adjuvant chemotherapy. Trastuzumab will be given intravenously 8mg/kg loading dose, followed by 6mg/kg every 3 weeks for one year.
16197597|NCT01413828|Drug|sequential|Trastuzumab will be administered sequentially to any anthracycline-containing regimen for breast cancer adjuvant chemotherapy. Trastuzumab will be given intravenously 8mg/kg loading dose, followed by 6mg/kg every 3 weeks for one year.
16197598|NCT01413815|Dietary Supplement|L-arginine|3.3 g of L-arginine capsules, oral,b.i.d for a period of three days (a variability ±2 days is accepted to enable scheduling of surgery according to requirements of clinical routine).
16197599|NCT01413815|Other|Placebo|3.3 g of placebo capsules/ b.i.d.; for a period of three days (a variability ±2 days is accepted to enable scheduling of surgery according to requirements of clinical routine)
16197600|NCT01413802|Procedure|Continuous nerve monitoring|Continuous nerve monitoring is performed during thyroid surgery.
16197601|NCT01413789|Drug|Dermatix|1 application of Dermatix
16197602|NCT01413789|Drug|Kelocote|1 application of Kelocote
16197603|NCT01413789|Drug|BAP scar gel|1 application of BAP scar gel
16197604|NCT01413789|Drug|Alhydran|1 application of Alhydran
16197605|NCT01413789|Drug|Bap Scar Care T|1 application of BAP Scar Care T
16197606|NCT01413789|Drug|Bap Scar Care S|1 Application of Bap Scar Care S
16197607|NCT01413789|Drug|Mepiform|1 application of Mepiform
16197608|NCT01413789|Drug|Scar Ban Elastic|1 application of Scar Ban Elastic
16197609|NCT01413776|Dietary Supplement|Corn Soya Blend+|A blended food consisting of corn (75-80%) and soybeans (20-25%) that has been fortified with a premix of 19 vitamins and minerals.
16197610|NCT01413763|Drug|Imiquimod cream 3.75%|3.75% cream, applied daily for 2 weeks
16197611|NCT01413763|Drug|Placebo cream|placebo cream applied daily for 2 weeks
16197612|NCT01413750|Drug|Paclitaxel|Given IV
16197613|NCT01413750|Drug|Carboplatin|Given IV
16197614|NCT01413750|Drug|Vorinostat|Given PO
16197615|NCT01413750|Other|Placebo|Given PO
16197616|NCT01413750|Other|Laboratory Biomarker Analysis|Correlative studies
16197617|NCT01413711|Drug|Vigabatrin|Oral vigabatrin as a single 25 mg/kg dose on Days 1 and 5, 25 mg/kg twice a day (50 mg/kg daily dose, orally) on Days 2-4
16197618|NCT01413685|Other|Pharmacokinetics/dynamics|Determination of tacrolimus concentrations in whole blood and of calcineurin activities in lymphocytes at D8, D15, D21 (pharmacokinetics on 4 times samples), D28, M2 and M3 (residual measurement)
16197619|NCT01413672|Device|Use of CASTLE barrier|Test barrier to be used in place of normal barrier. Otherwise normal routine is followed
16197620|NCT01413659|Biological|Symbiotic|Oral symbiotic every 8 h since 2 days before operation; Symbiotic resumes postoperatively on day +2 until day +4 for a total of 4 d of treatment (12 doses).
16197621|NCT01413646|Dietary Supplement|Walnut Supplementation|Eight weeks of walnut supplementation
16197622|NCT01413646|Dietary Supplement|No walnut supplementation|Eight weeks without walnut supplementation
16197623|NCT01413633|Procedure|cholecystectomy|single incision laparoscopic cholecystectomy
16197624|NCT01413620|Drug|dl-alpha-tocopheryl acetate|Ages 6 months-1 year will receive 75 IU/day of dl-alpha-tocopheryl acetate, while ages 2-5 years will receive 150 IU/day. Ages 6-8 will receive 300 IU/day, while ages 9-13 will receive 600 IU/day, ages 14-17 will receive 800 IU/day, and ages 18-70 will receive 1200 IU/day. Vitamin E will be administered in a liquid or pill form. The dose of aqueous vitamin E (Aqueous Vitamin E Oral Drops, Silarx, No. 54838-0005-30, Spring Valley, NY) will be given orally. When/If the patient is able to eat independently, the dose of vitamin E may be given in a pill form (Novatol 5-57, No. 410217, Archer Daniels Midland Company, Decatur, IL). Depending on the subject's group, the supplement of vitamin E either will be given on days 1-15 of the study or days 16-30 of the study.
16197625|NCT01413607|Device|Quill knotless tissue-closure device|The Quill knotless tissue-closure device is a barbed suture that allows the surgeon to keep tissue approximation without maintaining tension on the suture.
16197626|NCT01413607|Device|2-0 absorbable vicryl suture|In the control group a traditional 2-0 absorbable vicryl suture (Ethicon) will be used to close the central defect in the kidney.
16197627|NCT01413594|Behavioral|HABIT|90 hours of bimanual training over 3 weeks in a day camp environment
16197628|NCT01413581|Drug|rhBSSL (recombinant human bile-salt-stimulated lipase)|rhBSSL added to infant formula/pasteurized breast milk during a 4 week treatment period.
16197629|NCT01413581|Drug|Placebo|Placebo added to infant formula/pasteurized breast milk during a 4 week treatment period.
16197630|NCT01413568|Drug|POL6326|
16197631|NCT01413568|Procedure|Leukapheresis|
16197632|NCT01413568|Procedure|PBSC Transplant|
16197633|NCT01413555|Other|Blood Culture QI Program|The Blood Culture QI Program contains four components:(1) education: content knowledge and standardized experiential training on sterile technique designed for ED nurses; (2) process redesign: conversion of blood culture collection from a clean to a sterile technique using the Blood Culture Sterile Kit; (3) a checklist outlining optimal use of the Kit; (4) feedback of blood culture contamination rates to ED nurses who collect them.
16197634|NCT01413542|Drug|Sitagliptin (DPP4 inhibitor)|Sitagliptin 200 mg (DPP4 inhibitor) or matching placebo will be given one hour prior to intra-arterial infusions
16197635|NCT01413542|Drug|Substance P,|Substance P intra-brachial artery (2,4,8 pmol/min)
16197636|NCT01413542|Drug|bradykinin|bradykinin intra-brachial artery (23.6, 47.2, and 94.3 pmol/min)
16197637|NCT01413542|Drug|enalaprilat (ACE inhibitor)|intra-brachial artery(0.33 µg/min per 100 mL forearm volume)
16197638|NCT01413542|Drug|Glucagon-like peptide 1|intra-brachial artery (0.45-3.60 pmol/min)
16197639|NCT01413542|Drug|brain natriuretic peptide|Intra-brachial artery (0.90, 1.80 and 3.6 pmol/min)
16197640|NCT01413529|Behavioral|HEART to HAART|The HEART to HAART intervention is designed to enhance ongoing adherence counseling by providing (1) real time information about medication adherence (using Wisepill device); (2) periodic assessment of medication side effects, depressive symptoms and drug use frequency (as these are linked to poor adherence among drug users) using ecological momentary assessment and (3) tailored education, recommendation and encouragement based on assessments. The participant (using their phone) and their adherence team (using a clinician interface) can jointly track real time changes in adherence increasing the potential for shared decision-making.
16197642|NCT01413516|Behavioral|Smoking cessation counseling|Counseling sessions provided by a trained smoking counselor
16197643|NCT01413516|Drug|Placebo|Sugar pill without any active medication
16197644|NCT01413516|Drug|Varenicline|Varenicline (an approved medication for smoking cessation)
16197645|NCT01413503|Radiation|131I-MIBG|Therapeutic 131I-MIBG will be synthesized at Nuclear Diagnostic Products (NDP; Rockaway, New Jersey) with specific activities of 9-18 Ci/mmole. The therapeutic dose: 8-12 mCi/kg (maximum 1200 mCi ± 10% at investigator's discretion) will be diluted in 25 ml of normal saline, and will be infused intravenously through a patient's peripheral or central line over 120 minutes. The patient will remain in a radiation protected isolation room until radiation emissions are ≤ 2 mr/hr at a 1 meter distance or meets institutional and state guidelines. This usually takes 4-6 days. In all cases, special shielding will be equipped in the room to minimize exposure to the outside environment and personnel will observe institutional radiation safety precautions.
16197646|NCT01413490|Drug|rimantadine|12 weeks of rimantadine therapy in addition to standard combination therapy with interferon and ribavirin
16197647|NCT01413477|Drug|Calcipotriol, Betamethasone, Calcipotriol & Betamethasone|All study patients will be randomized to receive one of four topical ointments (calcipotriol, betamethasone dipropionate, combination of both calcipotriol/betamethasone dipropionate, or Vaseline petroleum jelly). Each subject will receive one unlabelled 5g tube for application to be dispensed by pharmacist, Rudy Chin. We expect approximately 2g of TOTAL use (0.125g applied twice daily over a 5 cm x 5 cm area on one forearm for 7 days). Typically, topical steroids such as betamethasone dipropionate have been used for treating a number of inflammatory skin conditions, including eczema. In addition, vitamin D analogues such as calcipotriol are used to treat psoriasis. Both agents, in our study, will be used on a small area of normal skin for a short 7 day course.
16197648|NCT01413451|Drug|Amatuximab (MORab-009)|
16197649|NCT01413438|Procedure|Craniotomy|
16197650|NCT01413412|Procedure|Ventral hernia repair using full thickness skin graft|25 patients
16197651|NCT01413412|Procedure|Ventral hernia repair using mesh|25 patients
16197652|NCT01413399|Drug|4 degree chilled saline|4 degree chilled saline up to 2L in the prehospital setting
16197653|NCT01413386|Device|biliary stent|palliative treatment for malignant patients
16197654|NCT01413373|Radiation|cone beam computed tomography|A preoperative CBCT is performed for all patients in this study for medical reason
16197655|NCT01413373|Radiation|computer tomography|One cone beam computer tomography examination before surgery
16197656|NCT01413360|Drug|High dose vitamin C|Vitamin C, 3g per day (tid), with meal, per oral with water 100mL
16197657|NCT01413347|Procedure|pillow|bronchoscopic confirmation of double-lumen tube position with a head on a pillow
16197658|NCT01413347|Procedure|neutral|bronchoscopic confirmation of double-lumen tube position in neutral position of a head
16197659|NCT01413295|Drug|Dendritic Cell Vaccine|Vaccination with autologous dendritic cells loaded with autologous tumor antigens
16197660|NCT01413295|Other|Supportive treatment|Supportive treatment after progression of the illness after 2 lines of chemotherapy
16197661|NCT01413282|Radiation|Cardiac CT|Calcium scan and CT coronary angiography
16197662|NCT01413269|Radiation|radiotherapy|"one group receives radiation to the whole breast to a total dose of 43.5Gy,at 2.9Gy per fraction, 5 fractions a week, followed by tumor bed boost of 8.7Gy, at 2.9Gy per fraction 5 fractions a week.
~the other group receives radiation to the whole breast to a total dose of 50Gy,at 2.0Gy per fraction, 5 fractions a week, followed by tumor bed boost of 10Gy, at 2.0Gy per fraction 5 fractions a week."
16197663|NCT01413243|Drug|Trichuris suis ova|Trichuris suis ova 2500 eggs every 2 weeks
16197664|NCT01413230|Drug|cholecalciferol|100 000 UI of cholecalciferol per week during 4 then 100 000 UI of cholecalciferol per month for 6 months
16197665|NCT01413204|Drug|TA-7284 Low|The patients will receive TA-7284-Low orally for 24 weeks.
16197666|NCT01413204|Drug|TA-7284 High|The patients will receive TA-7284-High orally for 24 weeks.
16197667|NCT01413204|Drug|Placebo|The patients will receive Placebo orally for 24 weeks.
16197668|NCT01413191|Biological|Cixutumumab|10 mg/kg IV infusion over 1 hour every 2 weeks with treatment cycle defined as 4 weeks
16197669|NCT01413191|Other|Laboratory biomarker analysis|Correlative studies
16197670|NCT01413178|Drug|Busulfan|Test dose (32 mg/m^2) on day -9 then 130 mg/m^2 by vein or adjusted dose on Days -7, -6, -5, and -4.
16197671|NCT01413178|Drug|Melphalan|70 mg/m2 by vein over 30 minutes minutes on Days -2 and -1.
16197672|NCT01413178|Other|Questionnaire|Quality of Life (QOL) questionnaire before starting the study drugs and then once every 4 weeks after the stem cell transplant, taking about 15 minutes to complete.
16197673|NCT01413178|Drug|G-CSF|Approximately 5 mcg/kg/day subcutaneously beginning on Day +5.
16197674|NCT01413178|Drug|High Dose Melphalan|200 mg/m2 by vein over 30 minutes on Day -2.
16197675|NCT01413178|Procedure|Stem cell transplant|Stem cell infusion on Day 0.
16197676|NCT01413152|Biological|blood and semen sampling, specific biological exams and biobank and self administered questionnaires|blood and semen sampling, specific biological exams and biobank and self administered questionnaires
16197677|NCT01413139|Device|4F portfolio products from Biotronik|4F portfolio products from Biotronik: Astron pulsar / Astron Pulsar-18, Fortress, Passeo-18, Cruiser-18
16197678|NCT01413126|Dietary Supplement|Whole peanuts without skins, Peanut butter, or no peanuts (control)|In accordance with the Food and Drug Administration qualified health claim regarding daily nut intake, 42.5 g of whole peanuts or peanut butter were added to a 75g available carbohydrate-matched breakfast meal each test session.
16197679|NCT01413113|Drug|pazopanib hydrochloride|Given PO
16197680|NCT01413113|Radiation|iodine I 131|Given IM
16197681|NCT01413100|Biological|Anti-Thymocyte Globulin|Given IV
16197682|NCT01413100|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo autologous PBSCT
16197683|NCT01413100|Drug|Cyclophosphamide|Given IV
16197684|NCT01413100|Biological|Filgrastim|Given SC
16197685|NCT01413100|Other|Laboratory Biomarker Analysis|Correlative studies
16197686|NCT01413100|Drug|Mycophenolate Mofetil|Given PO
16197687|NCT01413100|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo autologous PBSCT
16197688|NCT01413100|Drug|Plerixafor|Given SC
16197689|NCT01413100|Other|Quality-of-Life Assessment|Ancillary studies
16197691|NCT01413087|Biological|Biological/Vaccine: BC-819|"Post screening and prior to randomization, all patients will receive gemcitabine by IV infusion at a dose of 1000mg/m2 once weekly for four weeks. They may also enter the study if they received up to 4 doses of gemcitabine before entering the study. In this case, they will be randomized immediately provided there is no evidence of disease progression.
~After randomization patients will receive 6 weekly IV infusions of gemcitabine at a dose of 1000mg/m2 + 7 intratumoral injections of BC-819 (8 mg or 12 mg according to allocations by randomization)"
16197692|NCT01413074|Other|Peritoneal Dialysis treatment|PD treatment
16197693|NCT01413074|Other|Hemodialysis treatment|HD treatment
16197694|NCT01413061|Procedure|Subtalar Arthrodesis|
16197695|NCT01413048|Drug|Carvedilol 25mg|Tablet, q.d.
16197696|NCT01413048|Drug|AGSCT101 12.5mg|Tablet, q.d.
16197697|NCT01413035|Biological|MSC|1.0E+6 MSC/kg, IV drop in Day 0 and repeat to apply in Day 90 if the effect of MSC is better.
16197698|NCT01413022|Drug|Oxaliplatin|
16197699|NCT01413022|Drug|Irinotecan|
16197700|NCT01413022|Drug|Leucovorin|
16197701|NCT01413022|Drug|Fluorouracil|
16197702|NCT01413022|Other|laboratory biomarker analysis|Correlative studies
16197703|NCT01413022|Other|flow cytometry|Correlative studies
16197704|NCT01413022|Other|immunohistochemistry staining method|Correlative studies
16197705|NCT01413022|Other|pharmacological study|Correlative studies
16197706|NCT01413022|Drug|PF-04136309|
16197707|NCT01412996|Procedure|surgery|single ACCESS laparoscopic cholecystectomy
16197708|NCT01412996|Other|SURGERY|CONVENTIONAL LAPAROSCOPIC CGOLECYSTECTOMY
16197709|NCT01412983|Device|Bausch & Lomb Test lens|Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses.
16197710|NCT01412983|Device|Ciba Vision soft contact lens|Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses.
16197711|NCT01412970|Other|volume loading|volume loading according to functional parameters of cardiac preload, i.e. stroke volume variations measured by arterial pulse contour analysis
16197712|NCT01412957|Other|Best Supportive Care (BSC)|BSC was defined as the best palliative care available as judged appropriate by the investigator and according to institutional guidelines and could include antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any other symptomatic therapy as clinically indicated.
16197713|NCT01412957|Drug|Panitumumab|Administered intravenously
16197714|NCT01412944|Drug|secukinumab 150mg|secukinumab 150mg (2 injections per dose)
16197715|NCT01412944|Drug|secukinumab 10mg/kg i.v. regimen|secukinumab 10mg/kg i.v. regimen
16197716|NCT01412918|Device|The Inhibitor™ Tinnitus Masking Device|The Inhibitor™ Tinnitus Masking Device
16197717|NCT01412892|Drug|RAD001: Everolimus|10 mg of RAD001 will be self-administered orally once daily continuously for one year or until unacceptable toxicity or discontinuation from the study from any other reason.
16197727|NCT01412866|Behavioral|EDSS with CO feedback and health checklist|Web-based electronic decision support system with CO feedback and health-checklist
16197728|NCT01412866|Behavioral|EDSS with health checklist feedback alon|Web-based electronic decision support system (EDSS) with health-checklist feedback alone (without CO feedback)
16197729|NCT01412853|Other|MR-Spectroscopy|response to standard radiotherapy treatment will be estimated for each patient every 3 months up to one year from the end of the radiotherapy
16197730|NCT01412840|Other|Diclofenac and sterile water injections|The patients in the intervention group will be given standard treatment, i.e. intramuscular injection of 50 mg diclofenac. Patients in this group will also be given four subcutaneous injections of 0.5 ml sterile water at the same segmental level, i. e. the area in which the patient reports the pain.
16197731|NCT01412840|Other|Diclofenac and isotonic saline|The patients in this group will be given standard treatment, i.e. intramuscular injection of 50 mg diclofenac They will also be given four subcutaneous injections of isotonic saline at the same segmental level, i. e. the area in which the patient reports the pain.
16197732|NCT01412827|Radiation|1/2 dose of 99mTc OR 201Tl tracers|"Rest: Imaging will occur 30 to 60 minutes after injection of tracer.
~Stress: All patients will undergo a symptom-limited Bruce protocol treadmill exercise test. At peak stress, the radiotracer will be injected intravenously, and exercise will continue for an additional 60 s. The patients who are unable to achieve the targeted heart rate or exercise will be stressed pharmacologically. Dipyridamole (0.142 mg/kg/min) will be infused intravenously for 5 minutes, and 99mTc radiotracer will be injected at 2 min after infusion completion (7 min into the study). Aminophylline (100-200 mg) will be given intravenously 2 min after injection of the radiotracer."
16197733|NCT01412814|Device|AposTherapy Biomechanical System|The device is comprised of four adjustable modular elements attached to foot-worn platforms that are capable of manipulating the foot's center-of-pressure and applying perturbation training throughout the gait cycle. The device allows for neuromuscular training during dynamic loading.
16197734|NCT01412814|Other|Physical Therapy Program|Their therapy program will be similar to the experimental group, but without the treatment device (placebo walking shoe).
16197735|NCT01412801|Biological|Group B streptococcus vaccine|Subjects receive one dose of 5 μg of each of the 3 glycoconjugates present in the Group B streptococcus vaccine.
16197736|NCT01412788|Procedure|peri-areolar incision|peri-areolar incision was used to carry out lumpectomy in breast-conserving surgery.
16197737|NCT01412788|Procedure|traditional incision|Traditional incision above tumor was used to carry out breast-conserving surgery.
16197738|NCT01412775|Behavioral|short-term group intervention program|"The intervention will include three aspects: Psycho-educational intervention: attending a lecture about stress and exhaustion; Techniques for decreasing stress: experiencing relaxation techniques and guided imagery and a BALINT style group:analyzing actual work cases and cognitive-behavioral focusing for reframing thoughts and making them more adaptive, expressing emotions and training for more appropriate behaviors.
~The study includes three weekly sessions, Each session will be 90 minutes in duration."
16197739|NCT01412762|Behavioral|patient interviews|The pre-operative interview will be within 4 weeks of planned surgery and the postoperative interview within 8 weeks of surgery completion. This initial study is designed to develop an instrument to measure patient preoperative expectations in this patient population.
16197740|NCT01412762|Behavioral|CITSAV survey|Individual semi-structured qualitative interviews will be conducted with a total of 10 patients and 5 clinicians during this phase to identify and discuss levels of satisfaction, level of burden, potential obstacles to implementation, as well as suggestions for improving the intervention
16197741|NCT01412736|Drug|KHK4563|every 4 weeks for the first 3 doses on Weeks 0 (Day 1), 4, and 8 and then every 8 weeks thereafter for the last 4 doses on Weeks 16, 24, 32, and 40.
16197742|NCT01412736|Drug|KHK4563|every 4 weeks for the first 3 doses on Weeks 0 (Day 1), 4, and 8 and then every 8 weeks thereafter for the last 4 doses on Weeks 16, 24, 32, and 40.
16197743|NCT01412736|Drug|KHK4563|every 4 weeks for the first 3 doses on Weeks 0 (Day 1), 4, and 8 and then every 8 weeks thereafter for the last 4 doses on Weeks 16, 24, 32, and 40.
16197744|NCT01412736|Drug|Placebo|every 4 weeks for the first 3 doses on Weeks 0 (Day 1), 4, and 8 and then every 8 weeks thereafter for the last 4 doses on Weeks 16, 24, 32, and 40.
16197745|NCT01412723|Other|Ferrous sulfate as dietary supplementation|Ferrous sulfate as dietary supplementation
16197746|NCT01412723|Other|Iron amino acid chelated as dietary supplementation|Iron amino acid chelated as dietary supplementation
16197747|NCT01412710|Drug|Cholecalciferol|4000 IU or 6000 IU given vitamin D3 once daily, orally for 6 months.
16197748|NCT01412697|Behavioral|Fruit and vegetable intake in rural youth|A theory based health behavior intervention, developed for youth is presented to seventh grade youth over 8 weeks to test their improvement in their intake of fruits and vegetables.
16197749|NCT01412684|Procedure|Distal pancreatectomy with partial splenectomy|Distal pancreatectomy with partial splenectomy
16197750|NCT01412671|Drug|Sorafenib (Nexavar, BAY43-9006)|Patients who have received Nexavar for unresectable or advanced RCC.
16197751|NCT01412658|Dietary Supplement|Hydrolyzed milk protein mixture|Take twice a day, dosage 6 ml-21 ml based on weight, mix with 1/2 cup of milk.
16197752|NCT01412658|Dietary Supplement|Glycerol placebo|"Participants ingested 6ml-21ml of placebo mixed with 1/2 cup milk twice daily. The supplements were prepared in liquid form and packaged in generic bottles for double blind administration. The placebo was a starch-based placebo matched for color, texture, and taste to the active supplement.
~A food diary is maintained daily."
16197753|NCT01412645|Dietary Supplement|Resveratrol|"500mg resveratrol 2 times daily for 4 months (High-dose Resveratrol), 75mg resveratrol 2 times daily for 4 months (Low-dose Resveratrol) or
~1 placebo 2 times daily for 4 months"
16197754|NCT01412632|Drug|Remifentanil, propofol and citanest|iv remifentanil iv propofol im citanest
16197755|NCT01412606|Procedure|scratching|scratching endometrium on day 21-26 of a spontaneous menstrual cycle
16197756|NCT01412593|Biological|Stem cell transplant|Patients randomized to the intervention arm will be admitted to the Liver Care Unit. Granulocyte colony-stimulating factor (G-CSF; 300mcg/mL) will be administered for 1 day as a single daily subcutaneous dose. This dose is sufficient to induce 10 folds enrichment for bone marrow cells.
16197757|NCT01412580|Other|observational follow-up|observational follow-up
16197758|NCT01412567|Drug|Vaccine+HBIG|Recombinant hepatitis B vaccine at birth, 6 weeks, 10 weeks, and 14 weeks in the dose of 10 mcg (0.5 mL), by intramuscular injection in the anterolateral thigh; PLUS HBIG in the dose of 0.5 mL intramuscularly immediately after birth
16197759|NCT01412567|Drug|Vaccine+Placebo|Recombinant hepatitis B vaccine at birth, 6 weeks, 10 weeks, and 14 weeks in the dose of 10 mcg (0.5 mL), by intramuscular injection in the anterolateral thigh; PLUS placebo intramuscularly immediately after birth
16197760|NCT01412541|Procedure|Standard Uncoated Angioplasty Balloon|Subjects will be randomized 2:1 to the Moxy Drug Coated Balloon or Standard Angioplasty Balloon
16197761|NCT01412541|Device|Moxy Drug Coated Balloon|Subjects will be randomized 2:1 to the drug coated or standard angioplasty balloon
16197762|NCT01412528|Other|Allergen extracts|
16197763|NCT01412515|Drug|everolimus|everolimus per os 10mg per day
16197764|NCT01412502|Other|IES-R and HDAS scores|The Impact of Event Scale and Hospital Depression and Anxiety Score questionnaires are administered to participants.
16197765|NCT01412489|Device|HYALOBARRIER Gel|For each patient, the HYALOBARRIER Gel was introduced into the uterine cavity with the canula after hysteroscopic myomectomy procedure
16197766|NCT01412463|Device|stent placement|"pre-dilation of the study lesion is mandatory
~stent placement with 1 Protégé Everflex+ stent
~only 1 stent is allowed within the study protocol
~post-dilation may be performed but is not mandatory"
16197767|NCT01412450|Device|nitinol stent|implantation of one Protégé EverFlex stent
16197768|NCT01412437|Dietary Supplement|diet|12 participants will be randomized to diet. Phe levels will be followed by blood levels. A dietician will analyze diet for phe content and advise
16197769|NCT01412437|Drug|sapropterin dihydrochloride|20 mg/kg for 4 months
16197770|NCT01412437|Drug|sapropterin dihydrochloride|
16197771|NCT01412424|Drug|Octreotide capsules|Octreotide was provided in hard gelatin capsules.
16197772|NCT01412411|Behavioral|Nutritionl Education|to assess the change in behaviour
16197773|NCT01412411|Dietary Supplement|Oral Iron Supplementation along with Nturition Eductaion|
16197774|NCT01412411|Dietary Supplement|Multiple micronutrient fortification plus Nutrition Education|
16197775|NCT01412398|Drug|Lanthanum Carbonate (Fosrenol, BAY77-1931) - chewable tablet|Patients in CAPD who have received Fosrenol for hyperphosphatemia
16197776|NCT01412385|Biological|Immune Globulin Subcutaneous (Human), 20%|Subcutaneous infusion (regulated via a pump), Epoch 2 only (all subjects)
16197777|NCT01412385|Biological|Immune Globulin Intravenous (Human), 10%|Intravenous infusion (regulated via a pump)
16197778|NCT01412385|Biological|Human Normal Immunoglobulin (Subcutaneous - Intramuscular Immunoglobulin)|Subcutaneous infusion (regulated via a pump)
16197779|NCT01412372|Drug|Mesalamine|2 1.2g tablets once daily for 8 weeks. Patients randomized 50/50 to either Mesalamine or the Placebo
16197780|NCT01412372|Drug|Placebo|This is an inactive pill
16197781|NCT01412359|Drug|Omegaven®|Omegaven® 10% fat emulsion 1g/kg/day to infuse via IV over a period of 12 -24 hours every day until patient no longer requires intravenous lipid emulsion, is determined ineffective, or the patient stops participating in the study for any reason.
16197782|NCT01412346|Other|Effects of a Nordic diet rich in plant-based foods and fish|The intervention lasts for 20 weeks and it includes dietary counseling concerning salt restriction. Key foods are provided to the subjects.
16197783|NCT01412333|Drug|Interferon beta-1a|
16197784|NCT01412333|Drug|Ocrelizumab-matching placebo|
16197785|NCT01412333|Drug|Ocrelizumab|
16197786|NCT01412333|Drug|Interferon beta-1a-matching placebo|
16197787|NCT01412320|Other|Cocoa|dissolved in water twice daily
16197788|NCT01412320|Other|Cocoa|dissolved in water twice daily
16197789|NCT01412307|Drug|Lenalidomide|10, 15, 20 or 25 mg orally per cohort day 1-28 in a 28 days cycle
16197790|NCT01412307|Drug|Bendamustine|intravenous on days 1, 8 and 15 of each 28-days cycle at fixed dose of 60 mg/m2, as a 30-60 min i.v. infusion
16197791|NCT01412307|Other|Bio-specimen Retention|Samples with DNA and without DNA
16197792|NCT01412294|Drug|Capecitabine, Cisplatin|"Drug: Capecitabine Capecitabine will be administered at 1,000 mg/m2 orally, twice daily (2,000 mg/m2 total daily dose) on Days 1 through 14 of each 21-day treatment cycle.
~Drug: Cisplatin Cisplatin will be administered at 80 mg/m2 by intravenous infusion on Day 1 of each 21-day treatment cycle."
16197793|NCT01412281|Biological|Virosomal influenza vaccine (AdImmune HA Antigen)|Virosomal influenza vaccine (surface antigen, inactivated, virosome, using AdImmune HA Antigen) 2011/2012, with intramuscular administration, containing per 0.5 mL dose: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 μg HA antigen of B/Brisbane/60/2008-like virus
16197794|NCT01412281|Biological|Virosomal influenza vaccine (CSL HA Antigen)|Virosomal influenza vaccine (surface antigen, inactivated, virosome, using CSL HA antigen) 2011/2012 with intramuscular administration, containing per 0.5 mL dose: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 μg HA antigen of B/Brisbane/60/2008-like virus
16197795|NCT01412242|Other|Extensive search for isolated calf DVT|Extensive search for isolated calf DVT in patients with negative CUS of the proximal veins who have a high PTP and a positive D-dimer
16197796|NCT01412229|Drug|Cetuximab|Weekly cetuximab given intravenously for 6 weeks during induction chemotherapy and continue during the 2-3 week break prior to definitive chemoradiotherapy.
16197797|NCT01412229|Drug|Nab-paclitaxel|Weekly nab-paclitaxel given intravenously following cetuximab infusion for 6 weeks.
16197798|NCT01412229|Drug|Carboplatin|Weekly carboplatin given intravenously following nab-paclitaxel infusion for 6 weeks.
16197799|NCT01412216|Dietary Supplement|Fish Oil (Omega-3 Fatty Acids)|fish oil-4.4gm/day x 5 days
16197800|NCT01412216|Dietary Supplement|Fish Oil (Omega-3 Fatty Acids)|
16197801|NCT01412203|Behavioral|Action Schools! BC|AS! BC applies a socioecological, whole school approach to promote healthy living within the elementary school context. Schools are provided with the tools and support needed to create customized action plans that promote physical activity (PA) and healthy living across six Action Zones (School Environment, Scheduled Physical Education (PE), Classroom Action, Family and Community, Extra-curricular, School Spirit). Generalist teachers receive training and resources to implement their Action Plan with the ultimate goal of providing students with 150 minutes of PA/week. The model is choice-based; teachers are asked to provide 15 additional minutes of PA/day within the Classroom Action Zone. The activities require minimal equipment and can be performed in the classroom, hallway or on the school playground.
16197802|NCT01412190|Device|Restylane Vital Light|Treatment of up to 4 ml for one side of the face, one hand and one side of the décolletage dispensed by 10ul doses 0.5-1 cm apart. 3 treatment sessions 4 weeks apart.
16197803|NCT01412190|Other|No treatment|One side of face, one hand and one side of the décolletage is left untreated as a control.
16197804|NCT01412177|Drug|OTO-104|Single intratympanic injection of 12 mg OTO-104
16197805|NCT01412177|Drug|Placebo|Single intratympanic injection of placebo
16197806|NCT01412164|Device|FIREHAWK biodegradable polymer rapamycin-eluting stent|DES PCI for CAD
16197807|NCT01412151|Drug|Creatine monohydrate|Creatine taken twice daily for a total of 30 grams daily dosage or subject's highest tolerated dose
16197808|NCT01412138|Other|genetic analysis|"To identify by flow cytometry through technique of Side Population the population of somatic stem cells present in both human endometrial eutopic and ectopic endometrium of women with ovarian endometriosis, peritoneal and recto-vaginal.
~In vitro culture conditions for cell proliferation.
~To characterize the somatic stem cell population using techniques of endometriotic cell and molecular biology.
~Compare the results obtained from patients with endometriosis with control patients (without endometriosis) earlier work by our group."
16197809|NCT01412125|Other|Huntington patient evaluation|Neurological, neuropsychological, neuroimaging evaluation and biological sample
16197810|NCT01412125|Other|Healthy subject evaluation|Neurological, neuropsychological, neuroimaging evaluation and biological sample
16197811|NCT01412099|Behavioral|peer counseling|Participants receive 3 phone calls from a peer counselor to deliver counseling using motivational interviewing techniques focused on diet and physical activity behaviors over a 6 week period.
16197812|NCT01412099|Behavioral|Feedback report|Participants receive a one-page printed feedback report displaying their current levels of nutrition and physical activity behaviors and tips for meeting recommended guidelines.
16197813|NCT01412086|Drug|No Intervention|No Intervention.
16197814|NCT01412073|Drug|oxytocin|group I : oxytocin 5 IU bolus over 3 minutes after delivery of the baby group II : oxytocin 5 IU bolus over 3 minutes after delivery of the baby and oxytocin infusion in 500 ml 0.9% saline over 4 hours
16197815|NCT01412073|Drug|Misoprostol|misoprostol intrauterine 800 microgram placed intrauterine after delivery of the baby & the placenta
16197816|NCT01412060|Drug|Placebo|Placebo was supplied in capsules.
16199746|NCT01396694|Other|Questionnaire|Questionnaire
16197817|NCT01412060|Drug|Cariprazine|Cariprazine was supplied as 1.5 mg capsules (batch numbers BN0009242 and BN00018595) and 3 mg capsules.
16197818|NCT01412034|Drug|CER-001|Biweekly infusion
16197819|NCT01412008|Drug|Botox (botulinum toxin)|A series of three injections will be made simultaneously to the gastroc-soleus muscles of the affected lower limb; this will be the only drug intervention/injection session throughout the study, and occurs at baseline. The top injection site, closest to the knee, consists of 25 units of Botox and 0.25 cc saline. The bottom injection site, closest to the ankle, also consists of 25 units of Botox and 0.25 cc saline. The middle injection site will be considered the placebo injection, as it will not contain any Botox (0 units Botox) and 0.25 cc saline.
16197820|NCT01411995|Drug|2% lidocaine gel|3-5cc of 2% lidocaine gel will be applied to the lip of the cervix and within the endocervical canal prior to Intrauterine device insertion
16197821|NCT01411995|Drug|Water based lubricant|3-5cc of water based lubricant will be applied to the lip of the cervix and within the endocervical canal prior to intrauterine device insertion
16197822|NCT01411969|Drug|External Nasal Dilator Strip; 0.05% oxymetazoline chloride|External Nasal Dilator Strip placed above the upper lateral cartilage; 20 minutes after decongestion with 0.05% oxymetazoline chloride applied as an aerosol spray (two times); after decongestion with ENDS.
16197823|NCT01411956|Other|"24-minute video episode of patient education TV sitcom White Coats"|The series features a fictional married couple of Family Medicine physicians who work in the same practice, located in our community. In both their professional and private lives and, in moments both humorous and serious, these doctors teach patients about a wide variety of health topics. The intervention episode addressing hypertension will focus on three different patient-physician plot lines, which were developed to specifically address each of the beliefs about hypertension highlighted in the theoretical model (susceptibility, seriousness, barriers, self-efficacy and outcome efficacy.).
16197824|NCT01411956|Other|Placebo video|The control group watched a 25-minute patient education video on depression.
16197825|NCT01411930|Drug|Intramuscular olanzapine, aripiprazole|"1st clamp: single intramuscular 10.0 mg dose of olanzapine
~2nd clamp: single intramuscular 9.75 mg dose of aripiprazole"
16197826|NCT01411930|Drug|Intramuscular aripiprazole, olanzapine|"1st clamp: single intramuscular 9.75 mg dose of aripiprazole
~2nd clamp: single intramuscular 10.0 mg dose of olanzapine"
16197827|NCT01411917|Procedure|Transversus abdominis plane block|Ultrasound guidance will be utilized to inject 30ml of 0.375% bupivacaine into the muscular plane between the internal oblique and transversus abdominis muscles.
16197828|NCT01411904|Device|MagProbe (TM)|CD34 nanoparticles incubated in bone marrow and then extracted with the magnetic needle done at time of bone marrow biopsy
16197829|NCT01411891|Device|Chlorhexidine impregnated patch (Biopatch)|Patients assigned to the intervention group will have a chlorhexidine impregnated patch placed at the femoral nerve catheter insertion site.
16197830|NCT01411878|Behavioral|Reducing the Risk|Reducing the Risk: Building Skills to Prevent Pregnancy, STD and HIV (RtR) was developed by Richard Barth, MSW, Ph.D. in California. The training manual is in its 5th Edition and was last published in 2011. This curriculum is one of the first that was evaluated using an experimental design, with a longitudinal follow up (6 months and 18 months) and tested on a large group of high school students (N = 758). It is also one of the first programs to show an impact on beliefs of adolescent sexual behavior prevalence and actual behavior as well as increasing parent-child communication about abstinence and contraception (Kirby, Barth, Leland, and Fetro, 1991).
16197831|NCT01411878|Behavioral|Love Notes|The second healthy relationships program for high-risk youth, Love Notes, was developed to educate participants about healthy relationships, including issues of decision-making, communication and conflict resolution, and overall safety, including the prevention of pregnancy and sexually transmitted disease (Pearson, 2009). Love Notes is a derivative of the Prevention and Relationship Enhancement Program (PREP; Stanley, Markman, & Jenkins, 2009), which is relationship marriage education program listed as an evidence-based practice (EBP) by SAMSHA (www.samhsa.gov). This curriculum builds on social exchange theory and meets the needs of youth who are alienated and in need of loving personal relationships.
16197832|NCT01411865|Other|Toolkit|Cardiovascular Disease Toolkit mailed by the Canadian Diabetes Association to family physicians, accompanying the Spring/Summer 2009 edition of the quarterly newsletter, Canadian Diabetes. (Mailed in June 2009.) The Toolkit includes a summary of selected sections of the practice guidelines targeted towards primary care physicians; a synopsis of the key messages pertaining to cardiovascular disease risk; a laminated card with a simplified algorithm for cardiovascular risk assessment and treatment; and a pad of tear-off sheets for patients with a cardiovascular risk self-assessment tool.
16197833|NCT01411865|Other|Control|The Spring/Summer 2009 issue of the quarterly newsletter, Canadian Diabetes, mailed on its own. The Cardiovascular Toolkit was mailed with the May 2010 issue of the newsletter.
16197834|NCT01411852|Drug|0.9% Sodium Chloride 250 mL bolus|Emergency Medicine Systems (EMS) agencies and in-hospital providers will be given the option to utilize either systolic blood pressure (SBP) or radial pulse as the endpoint for fluid resuscitation to patients randomized to the experimental group. Patients will receive a 250 ml bolus of normal saline (NS) only if the SBP is less than 70 mmHg or the radial pulse is not palpable. If the SBP is greater than or equal to 70 mmHg or the radial pulse is palpable, NS will be given to keep the vein open. The presence or absence of a radial pulse or the SBP will be documented before and after each bolus. The study will continue repeating the randomization procedure using only 250 ml bags of NS until 2 hours after arrival to the hospital or until hemorrhage control is achieved whichever occurs first.
16197835|NCT01411852|Drug|0.9% Sodium Chloride 2000 mL bolus|Emergency Medicine Systems (EMS) personnel and in-hospital providers will utilize the systolic blood pressure SBP as the endpoint for delivering fluid resuscitation to patients randomized to the control group. If the SBP is equal to or less than 90 mmHg, the EMS personnel will start infusing a 1000 ml bolus of normal saline (NS) and will continue using only 1000 ml bags of NS as needed. If the total fluid resuscitation exceeds 2 liters, fluid will be stopped when the SBP exceeds 110 mmHg and restarted as necessary to maintain a goal SBP of 110 mmHg. The fluid will be given as rapidly as possible. This fluid resuscitation protocol will continue until either 2 hours after hospital arrival or until control of hemorrhage is achieved whichever occurs first.
16197836|NCT01411839|Behavioral|Cognitive-Behavioral Therapy (CBT-AD)|CBT-AD is a therapy program intervention that uses one-on-one and face-to-face patient-therapist sessions.
16197897|NCT01411293|Other|Rice Milk|Participants will ingest 2 cups of rice milk on 1 occasion.
16197837|NCT01411826|Behavioral|Information + Narratives + Support Group|Information from CDC website Narratives about CRCS written by others Peer social support among study participants
16197838|NCT01411826|Behavioral|Information Only|Information from CDC website on colon cancer screening.
16197839|NCT01411800|Drug|250 mg capsule|Two 250 mg capsules will be administered for 500 mg dose
16197840|NCT01411800|Drug|250 mg tablets|Two 250 mg tablets will be administered for a 500 mg dose
16197841|NCT01411787|Behavioral|Exercise|Five woman undergoing neoadjuvant chemotherapy for breast cancer will be randomized to an exercise protocol supervised by an experienced personal trainer. The exercise will be administered three times a week for the 4-6 months of neoadjuvant chemotherapy. The exercise protocol will consist of activities including walking/running up to a mile, calisthenics, and light weightlifting.
16197842|NCT01411774|Behavioral|Cognitive-behavioral therapy|All patients will receive 10 sessions of therapy over 8 weeks using the evidence-based CBT protocol in POTS (2004). Sessions 1-4 will be held twice weekly; sessions 5-10 will be held on a weekly basis. Sessions 1-3 do not include exposures and are devoted to psychoeducation, cognitive therapy, and hierarchy development. Sessions 4-10 involve E/RP exercises specific to each youth.
16197843|NCT01411774|Drug|d-cycloserine|D-cycloserine will be encapsulated into 25mg with identical placebo capsules. Youth will take (1 or 2) DCS or identical placebo capsule 1 hour before sessions 4-10. A 0.7mg/kg dosage corresponds with dosages found to be effective in adult studies (50mg/estimated average adult weight of 70kg=.71mg/kg). Accordingly, doses for this study will be about 0.7mg/kg. Two dosing levels will be used based upon weight ranges to ensure comparable mg/kg levels: children weighing 25-45kg will be given a dosage of 25mg (~0.56-1.0 mg/kg/day), and children ≥46kg will be given 50mg provided in two 25mg capsules (~0.50-1.08mg/kg/day). Doses will be given 1 hour before therapy sessions 4-10.
16197844|NCT01411774|Drug|Pill placebo|The pill placebo will be identical to the active study medication in every respect (e.g., size, shape, number of capsules, etc.).
16197845|NCT01411761|Dietary Supplement|Reflor|5 million unit/day, first 15 day of life
16197846|NCT01411761|Other|serum physiologic|1 cc added to one feeding in a day
16197847|NCT01411748|Dietary Supplement|Reflor|5 million unit/day, orally, beginning on the second day of life, until discharge from hospital
16197848|NCT01411748|Drug|mikostatin|50000 unit/3 times a day, both for orally and by orogastric route
16197849|NCT01411735|Drug|Enalapril|2.5mg titrated up to 10mg twice daily
16197850|NCT01411735|Drug|placebo|2.5mg titrated up to 10mg twice daily.
16197851|NCT01411722|Device|Neurally adjust ventilatory assist (NAVA) and a nasogastric tube to measure the electrical activity of the diaphragm (EAdi catheter)|Nava is a new ventilatory mode which delivers pressure in proportion of the the Electrical activity of the diaphragm (EAdi), a reflection of the neural respiratory output. EAdi will be obtained through a nasogastric tube with a multiple array of electrodes placed at its distal end. Correct positioning of the EAdi catheter is assured by means of a specific function of the ventilator (''EAdi catheter positioning''). The EAdi signal is processed according to the American Thoracic Society (ATS) recommendations and filtered by algorithms designed to provide the highest possible signal-to-noise ratio
16197852|NCT01411709|Drug|Vitano|two 200mg tablets per day for 14 days
16197853|NCT01411696|Drug|dexamethasone intravitreal implant 0.7 mg|Dexamethasone intravitreal implant 0.7 mg was dosed previously according to general clinical practice.
16197854|NCT01411683|Device|Implant-retained mandibular overdenture|Insertion of implants in the lower arch in order to retain existing complete dentures. Tested implants are approved by the Brazilian National Health Surveillance Agency for clinical use.
16197855|NCT01411670|Drug|Human protein C concentrate|Continuous infusion of human protein C concentrate at the dose of 3 UI/Kg/Hr to reach a protein C plasma activity of 70-120%
16197856|NCT01411670|Drug|Activated protein C|Continuous infusion of activated protein C at the dose of 24 micrograms/Kg/Hr for 96 hours
16197857|NCT01411670|Drug|Placebo comparator|Standard treatment
16197858|NCT01411657|Drug|NT-501 CNTF Implant|Single implantation of CNTF-secreting NT-501 device into one eye
16197859|NCT01411631|Dietary Supplement|Grape juice polyphenols|Participants will consume grape juice polyphenols for 12 weeks and a control juice for 12 weeks.
16197860|NCT01411618|Other|free alcohol essential oil mouthwash|All subjects were instructed to rinse twice a day, in the morning and in the evening, with 20 ml solution for 60 seconds, after which they expectorated. Subsequent rinsing with water was not allowed.
16197861|NCT01411605|Behavioral|Exercise training|"12-week supervised exercise-training (ET) program consisting of two 60-min and one 120-min exercise sessions per week which focus mainly on aerobic exercises (cycling, treadmill, rower).
~Initial aerobic exercise intensity is set at 60 % of HR peak and will reach 80 % at the end of the ET protocol."
16197862|NCT01411592|Other|Multilink|After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using an adhesive bonding system with a phosphonic acid acrylate primer for the zirconia ceramic (Multilink-Automix bonding system with Metal/Zirconia primer)
16197863|NCT01411592|Other|Panavia 21 TC|After air-abrasion of the retainer wings (50 µm alumina particles at 0.25 MPa) and etching the enamel with 36% phosphoric acid for 30 sec, the RBFDPs were inserted using a phosphate monomer containing resin (Panavia 21 TC) without any primer
16197864|NCT01411566|Behavioral|Skills trainig for patients with dual diagnosis|Skills trainig for patients with dual diagnosis
16197865|NCT01411566|Behavioral|regular treatment|regular treatment
16197866|NCT01411553|Other|Disposable ECG-LW|Disposable ECG leadwires used in ICU and telemetry monitoring; 5 lead sets for ICU and 6-lead sets for telemetry
16197867|NCT01411540|Dietary Supplement|Whole grains|Comparison of a diet containing whole grain compared to an energy matched diet based on similar foods, but using refined grains.
16197868|NCT01411514|Drug|Prednisone|Tablets, 60 mg od p.o. for 5 days, followed by 40 mg o.d. p.o. for 5 days, 20 mg o.d. p.o. for 5 days, 10 mg o.d. p.o. for 5 days, 5 mg o.d. p.o. for 5 days
16197869|NCT01411514|Drug|Placebo|Placebo tablets. They will be administered during 25 days
16197898|NCT01411280|Drug|methylphenidate|Ritalin 10mg, Ritalin 20mg
16197899|NCT01411267|Drug|AC220|Dose assigned at study entry. AC220 will be given orally once daily on days 7-28.
16197952|NCT01410916|Drug|Eculizumab (Soliris®)|Eculizumab 300 mg, 600 mg, 900 mg or 1200 mg will be administered intravenously
16197870|NCT01411501|Other|acupuncture|"Thrust and lift the needle to achieve De Qi. After being needled, the points will be punctured again using auxiliary needles 2 mm lateral to the first needle, and to a depth of 2 mm without manual stimulation. Put the electric stimulator on the pair of needles with a continuous wave, 20Hz. The current intensity is increased to the patients' maximum tolerance and then slightly reduced to a bearable level (0.1-1.0 mA).
~Huatuo Brand needle (φ0.30×25mm,φ0.30×40mm,φ0.30×50mm, produced by Suzhou Medical Appliance Factory) and G6805-1A electro-acupuncture apparatus(produced by Shanghai Huayi Medical Instrument Co. Ltd.) will be used.
~Five sessions/week in the first 2 weeks, three sessions/week for in the last 2 weeks."
16197871|NCT01411501|Drug|mosapride citrate|4-week oral use of mosapride citrate, 5mg, three times daily 0.5 hour before meal
16197872|NCT01411488|Device|Fecal management system|rectal tubes/fecal management systems: we compared products to determine if there is a difference in the incidence of anal erosions
16197873|NCT01411475|Other|Bifurcation restenosis classification|Classification of restenosis involving coronary bifurcation according to their pattern
16197874|NCT01411462|Device|VIBE + drug-eluting balloon|VIBE before and after durg-eluting balloon angioplasty
16197875|NCT01411449|Drug|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Patients who will need to undergo contrast enhanced MRI with Primovist
16197876|NCT01411436|Drug|Sorafenib (Nexavar, BAY43-9006)|Patients who have received Nexavar for unresectable HCC
16197877|NCT01411423|Drug|Sorafenib (Nexavar, BAY43-9006)|Patients who have received Nexavar for unresectable or advanced RCC.
16197878|NCT01411410|Drug|Paclitaxel|"Paclitaxel (80 mg/m2 in Cohort 1, 2 and 3, 90 mg/m2 in Cohort 4) as 60-minute iv infusion once weekly on Days 1, 8, 15 and 22 (Day 22 in Cohort 1, 2 and 3 only) in 28-day cycles
~The following intravenous premedications are required 30 to 60 minutes before paclitaxel infusion: Dexamethasone (10 mg), diphenhydramine (50 mg) and either cimetidine (300 mg) or ranitidine (50 mg)
~Alternatively, for premedications other than dexamethasone, the standard institutional regimen is permitted."
16197879|NCT01411410|Drug|Copanlisib (BAY80-6946)|BAY80-6946 (0.6 mg/kg in Cohort 1, 0.8 mg/kg in Cohort 2, 3 and 4) as 60-minute iv infusion once weekly on Days 2, 9, 16 and 23 (Day 23 in Cohort 1, 2 and 3 only) in 28-day cycles
16197880|NCT01411397|Other|SURGERY|REPAIR OF STRANGULATED HERNIA with intestinal resection
16197881|NCT01411397|Other|mesh repair|mesh repair of strangulated hernia without resection
16197882|NCT01411384|Procedure|Corneal collagen cross-linking|The same surgical procedure was applied to all keratoconus patients that included: Instillation of proparacaine hydrochloride 0.5% drops for topical anaesthesia, application of a sponge saturated with 10% alcohol to the central cornea for 30 seconds and subsequent de-epithelialization. Following de-epithelialization, a mixture of 0.1% riboflavin in 20% Dextran solution was instilled to the cornea for 30 minutes (2 drops every 2 minutes) prior to the irradiation, until the stroma was completely penetrated and aqueous was stained yellow. An 8.0mm diameter of central cornea was irradiated for 30 minutes by UVA light with a wavelength of 370nm and an irradiance of 3mW/cm2. Instillation of riboflavin drops (1 drop every 2 minutes) was continued during irradiation. Balanced salt solution (BSS) was applied every 6 minutes to moisten the cornea.
16197883|NCT01411384|Device|Ocular Response Analyzer (ORA)|An air puff is released by a non-contact probe, which scanned the central area of the eye and send a signal to the ORA device. The air puff causes the cornea to move inward, past applanation, and into slight concavity. After milliseconds, the air pumps shut off, the pressure decreases, and the cornea begins to return in its normal state. The system monitors the entire process and measures two pressure values, which are determined from the inward and outward applanation processes. The aforementioned measuring procedure enables the determination of Corneal Hysteresis and Corneal Resistance Factor.
16197884|NCT01411371|Procedure|Catheter ablation of persistent atrial fibrillation|Catheter ablation of AF as described previously by our group (e.g. Hunter et al, Heart 2010).
16197885|NCT01411371|Drug|Medical treatment alone|Medical treatment of persistent AF as 'normal care'. Patients are randomised to medical treatment alone for atrial fibrillation. Treatment will be as per current guidelines for persistent atrial fibrillation, with rate control as first line (using beta-blockers, calcium channel blockers and digoxin as indicated) and rhythm control as second line (using sotalol, dronedarone, or amiodarone as indicated). (Both groups will receive standard heart failure medication including angiotensin converting enzyme inhibitors, beta blockers, aldosterone antagonists, and diuretics as indicated).
16197886|NCT01411358|Biological|non-elderly aged between 18 and 60|one dose of 0.5mL AdimFlu-S
16197887|NCT01411358|Biological|elderly aged over 60|one dose of 0.5mL AdimFlu-S
16197888|NCT01411345|Radiation|Standard Salvage Radiation Treatment (SSRT)|A total dose of 68 Gy delivered in 34 fractions to the Clinical Target Volume (CTV), 51 Gy in 34 fractions can be given to the pelvic nodes.
16197889|NCT01411345|Radiation|Mapped Tumor Salvage RT (MTSRT)|Dose escalation to the imaging or Dynamic Contrast Enhanced MRI (DCE-MRI)-defined dominant region(s) by dose painting at 2.25 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 68 Gy. The mapped tumor (MT) boost region will receive an absolute dose of 76.5 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 80 Gy in 2.0 Gy fractions.
16197890|NCT01411332|Radiation|SIMRT|A total dose of 80 Gy will be delivered in 40 fractions to the Clinical Target Volume (CTV).
16197891|NCT01411332|Radiation|HTIMRT|Dose escalation to the Multiparametric MRI (MP-MRI) by dose painting at 2.35-2.40 Gy per fraction, while the rest of the Clinical Target Volume (CTV) receives 2.0 Gy a fraction to 76 Gy. The hypofractionated targeted (HT) boost region will receive an absolute dose of 89.3-91.2 Gy. Assuming an α/β ratio of 3.0, this would be equivalent to 95.5 Gy in 2.0 Gy fractions.
16197892|NCT01411319|Radiation|Lattice Extreme Ablative Dose Radiation Therapy|12 - 14 Gy dose pipes in 1 fraction to the multiparametric MRI defined gross tumor volumes (GTV) on Day 1.
16197893|NCT01411319|Radiation|Standard IMRT|76 Gy in 38 fractions (2 Gy daily) of Standard Intensity-modulated radiation therapy (IMRT) starting on Day 2 for 7.5 weeks.
16197894|NCT01411306|Other|Toronto Bedside Swallowing Screening Test (TOR-BSST©)|All enrolled patients will be screened for dysphagia by two blinded screeners using the TOR-BSST©.
16197895|NCT01411306|Procedure|Videofluoroscopic Swallow Study|All enrolled patients will undergo a videofluoroscopic assessment of swallowing within 24 hours of being screened with the TOR-BSST©.
16197896|NCT01411293|Other|Low-Fat Milk|Participants will ingest 2 cups of low-fat milk on 1 occasion.
16198109|NCT01409603|Drug|darexaban|oral
16197900|NCT01411267|Drug|Cytarabine|"All patients receive 1000 mg/m2/day IV given every 12 hours on days 1 through 5. Additionally, AML patients and patients with ambiguous leukemia receive cytarabine intrathecally on day 1 of course 1 and 2. Dose defined by age:
~20 mg for patients age <1 yr
~30 mg for patients age 1-1.99 years of age
~50 mg for patients age 2-2.99 years of age
~70 mg for patients >3 years of age"
16197901|NCT01411267|Drug|Etoposide|150 mg/m2/day IV on days 1 through 5.
16197902|NCT01411267|Drug|Methotrexate|"IT methotrexate given intrathecally to patients with ALL on day 0 of course 1 and 2. Dose defined by age
~6 mg for patients age < 1yr
~8 mg for patients age 1-1.99
~10 mg for patients age 2-2.99
~12 mg for patients 3-8.99 years of age
~15 mg for patients >9 years of age"
16197903|NCT01411254|Drug|Betamethasone Microsphere (DE-102） Low Dose|
16197904|NCT01411254|Drug|Betamethasone Microsphere (DE-102） High Dose|
16197905|NCT01411254|Drug|Sham|
16197906|NCT01411241|Biological|Live, attenuated, recombinant dengue serotype 1, 2, 3, and 4 virus|0.5 mL, subcutaneous at age 9 to 12, 15 to 18 and 21 to 24 months.
16197907|NCT01411241|Biological|DTaP IPV//Hib vaccine|0.5 mL, intramuscular
16197908|NCT01411241|Biological|Placebo|0.5 mL, subcutaneous
16197909|NCT01411241|Biological|Measles, mumps, and rubella vaccine|0.5 mL, subcutaneous
16197910|NCT01411241|Biological|Pneumococcal vaccine|0.5 mL, intramuscular
16197911|NCT01411241|Biological|Live, attenuated, recombinant dengue serotype 1, 2, 3, and 4 virus|0.5 mL, subcutaneous at age 9 to 12, 16 to 19 and 21 to 24 months
16197912|NCT01411241|Biological|DTaP IPV//Hib vaccine|0.5 mL, intramuscular
16197913|NCT01411241|Biological|Placebo|0.5 mL, subcutaneously
16197914|NCT01411241|Biological|Measles, mumps, and rubella vaccine|0.5 mL, subcutaneous
16197915|NCT01411241|Biological|Pneumococcal vaccine|0.5 mL, intramuscular
16197916|NCT01411228|Drug|Taliglucerase alfa|Taliglucerase alfa for infusion every two weeks for 24 months
16197917|NCT01411215|Drug|Enbrel|25mg biweekly or 50mg per week, subcutaneous injection
16197918|NCT01411202|Drug|Doxycycline|One time injection 500mg of powdered doxycycline reconstituted with 50cc of normal saline via Pleurx catheter
16197919|NCT01411202|Other|normal saline|One time injection of normal saline (placebo) into Pleurx catheter
16197920|NCT01411189|Drug|Menthol|20 mL NPO-11 in prefilled syringe
16197921|NCT01411176|Drug|Menthol|20 mL NPO-11 in a prefilled plastic syringe
16197922|NCT01411176|Drug|Placebo|The placebo is included same additives as active comparator.
16197923|NCT01411163|Drug|Creatine monohydrate|Up to 30 grams daily creatine monohydrate
16197924|NCT01411150|Drug|Creatine Monohydrate|Up to 30 grams daily creatine monohydrate
16197925|NCT01411137|Drug|IPX066|"Subjects were converted from their current treatment to IPX066 over a 6-week period.
~Experimental Drug Product: IPX066 (carbidopa-levodopa) extended-release capsules"
16197926|NCT01411124|Drug|gabapentin enacarbil|600 mg investigational compound
16197927|NCT01411124|Drug|diphenhydramine|50 mg active comparator
16197928|NCT01411124|Drug|placebo|placebo
16197929|NCT01411111|Drug|Rosuvastatin 10 mg|days 1-14
16197930|NCT01411111|Drug|GSK2190915 30mg|1x30mg tablet, days 8-14
16197931|NCT01411111|Drug|GSK2190915 100mg|1x100mg tablet, days 8-14
16197932|NCT01411098|Radiation|3-dimensional conformal radiation therapy|Undergo 3D-CRT
16197933|NCT01411098|Radiation|intensity-modulated radiation therapy|Undergo IMRT
16197934|NCT01411098|Drug|cisplatin|Given IV
16197935|NCT01411098|Drug|etoposide|Given IV
16197936|NCT01411085|Drug|Risperidone + Desipramine|
16197937|NCT01411072|Drug|gemcitabine|Gem 1000 mg/m2 IV weekly for 3 weeks then one week off of each 28 day cycle
16197938|NCT01411072|Drug|5-fluorouracil|5-FU 425 mg/m2 and Leucovorin 20 mg/m2 IV day 1, 2, 3, 4, and 5 of each 28 day cycle
16197939|NCT01411059|Behavioral|yoga|yoga classes 2 times per week for 32 weeks
16197940|NCT01411046|Diagnostic Test|Synacthen test|250 microg Synacthen test, performed fasting, in the morning, starting between 08·00 and 10·30 h, after an overnight fast and a prednisolone pause of approximately 48 hours (depending on normal dose administration time).
16197941|NCT01411020|Procedure|endotracheal intubation|to perform endotracheal intubation if number of bispectral index (BIS) is 40-60,
16197942|NCT01410968|Drug|vacc. w/ Poly-ICLC & peptide-pulsed dendritic cells|Intradermal injection of 1x107 peptide-pulsed dendritic cells followed by intramuscular injection of 30 micrograms per kilogram Poly-ICLC on days 0, 14, 28 and 42. Additional dose of 30 micrograms per kilogram Poly-ICLC on days 3, 17, 31 and 45. Treatment given via one 56-day cycle. Leukapheresis performed at baseline for dendritic cell generation.
16197943|NCT01410955|Dietary Supplement|Probiotic formula|Probiotic formula Colon DophilusTM , will be administered at a dose of 3x1 cps per day orally for 12 weeks. In the first cycle the starting dose is 3x1 cps per day. In other cycles the starting dose is 3x1 cps per day, or the dose according to dose adjustments from the previous treatment cycle.
16197944|NCT01410955|Dietary Supplement|Placebo|Placebo capsules will be administered at a dose of 3x1 cps per day orally for 12 weeks. In the first cycle the starting dose is 3x1 cps per day. In other cycles the starting dose is 3x1 cps per day, or the dose according to dose adjustments from the previous treatment cycle.
16197945|NCT01410942|Other|Placebo|Capsules by mouth twice daily.
16197946|NCT01410942|Drug|Methylphenidate|Starting dose 5 mg by mouth twice daily.
16197947|NCT01410942|Behavioral|Counseling Sessions|8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each.
16197948|NCT01410942|Other|Sham Exercise|Participants in placebo/sham exercise intervention meet with exercise physiologist in person on first visit to learn stretching exercises and receive written instructions same as those receiving exercise therapy.
16197949|NCT01410942|Other|Standardized Exercise Intervention Program|Resistance exercise sessions completed 3 days a week allowing at least 48 hours between each session, and walk minimum of 5 days a week at intensity and duration established by exercise physiologist.
16197950|NCT01410942|Other|Cognitive Behavioral Therapy (CBT)|8 weekly sessions (1 in person and 7 by telephone) lasting 45 minutes each, during which review learned relaxation skills and taught new cognitive and/or behavioral skill.
16197951|NCT01410929|Procedure|Kyphoplasty/Vertebral Augmentation (Device-StabiliT)|Targeted Vertebral Augmentation for the treatment of pathological fractures of the spine caused by multiple myeloma
16197953|NCT01410903|Device|TheraSorb Ig|1,5 plasma volume per treatment venovenous immunoadsorption frequency: three times weekly in week 1 and 2, two times weekly in week 3-6, two times two-weekly in week 7-12 duration: 12 months
16197955|NCT01410864|Device|DuraSeal Exact Spine Sealant System|DuraSeal Exact Spine Sealant System will be administered to those eligible patients, to treat a dural opening.
16197956|NCT01410864|Other|Control|Devices or drugs used to seal the dura (other than DuraSeal)
16197957|NCT01410851|Other|dietary treatment|A within-subject, balanced repeated-measures design was followed where subjects received 4 treatments or control over 5 weeks approximately 1 week apart. The pulse treatments contained: (1) chickpeas (Primo, Toronto, ON), (2) lentils (Primo, Toronto, ON), (3) navy beans (Ferma, Toronto, ON) or (4) yellow peas (Nupak, Toronto, ON).
16197958|NCT01410838|Other|Broth|200 mL of sodium chloride containing broth, consumed three times per day
16197959|NCT01410838|Other|Broth|200 mL of MSG containing broth consumed three times per day
16197960|NCT01410825|Biological|Retrovirus-mediated gene transfer|Two procedures: 1) Bone marrow harvest from the patient's posterior iliac crests or collection of peripheral blood stem cells via apheresis procedure. 2) One time infusion of patient's transduced bone marrow cells.
16197961|NCT01410812|Behavioral|Control|Receive weekly emails asking participants about their exercise and receive cash.
16197962|NCT01410812|Behavioral|Suggested Tying Intervention|Participants receive 4 iTunes audio novels for their own iPods to listen to only at the gym
16197963|NCT01410812|Behavioral|Forced Tying Intervention|Participants receive cash and also 4 iTunes audio novels for a loaned iPod accessible only at the gym to listen to only at the gym.
16197964|NCT01410799|Drug|Growth Hormone Releasing Hormone (GHRH )|GHRH administered subcutaneously at 2.0 mg/kg/dose bolus each night at 11:00 PM, 1:00 AM, 3:00 AM, and 5:00 AM for 12 weeks
16197965|NCT01410786|Procedure|Conventional Instrumentation|Standard Oxford surgical instruments
16197966|NCT01410786|Procedure|Signature Custom Guides|Signature Custom Guides used with Instruments in surgical technique
16197967|NCT01410773|Device|Ninja 2 Investigational Blood Glucose Monitoring System|The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor.
16197968|NCT01410760|Other|Perfusion CT scan|Patients in this imaging substudy of the FOXFIRE clinical trial will undergo a perfusion CT prior to FOXFIRE protocol therapy( Ox/MDG chemo alone for 12 cycles in arm A or OX+MDG chemo for 12 cycles with Yttrium 90 SIRshpheres liver radioembolisaton in arm B cycle 2) on Day 1/2 cycle 2, Day 1/2 cycle 3 and Day 1/2 cycle 5 chemotherapy.
16197969|NCT01410747|Drug|Tacrolimus|oral
16197970|NCT01410734|Drug|Indocyanine green (ICG)|2.5mg indocyanine green (ICG) will be administerly (IV injection) 30 minutes before surgery
16197971|NCT01410721|Behavioral|Cognitive Rehabilitation Intervention|Baseline training and follow-up at two months and four months.
16197972|NCT01410721|Behavioral|Cognitive Rehabilitation Control Intervention|Baseline training and follow-up at two months and four months.
16197973|NCT01410708|Drug|Dasatinib|
16197974|NCT01410695|Drug|masitinib 3 mg|
16197975|NCT01410695|Drug|masitinib 6.0 mg|
16197976|NCT01410695|Drug|methotrexate|
16197977|NCT01410695|Drug|Placebo (methotrexate)|
16197978|NCT01410695|Drug|Placebo (masitinib)|
16197979|NCT01410682|Other|0,12% digluconate chlorhexidine|Oral care with 0.12% Chlorhexidine Digluconate and toothbrushing is realized twice a day and took about 10 minutes to complete, depending on the child's acceptance and clinical conditions.
16197980|NCT01410682|Other|toothbrushing|Gel is applied on a toothbrush, and the teeth are cleaned in quadrants; all teeth surfaces are cleaned (vestibular, lingual, occlusal, and incisal). After each quadrant is cleaned, 10 mL of water (dispensed via a syringe) is used to rinse the quadrant and continual aspiration is used to remove all the gel and debris. After all the teeth are cleaned, the ventral surface of the tongue is brushed with posterior to anterior movements.
16197981|NCT01410669|Behavioral|Motivational interviewing (MI)|"MI is a client-centered counseling approach developed to deliver stage-tailored intervention messages using non-confrontational, supportive communication strategies. The client is encouraged to explore the barriers and facilitating factors associated with the behavior change. The interviewer's role is to guide the conversation and avoid use of conventional directive approaches (e.g., persuasion, providing information).
~In this trial, a trained motivational interviewer meets individually with patients randomized to the intervention for one-hour at baseline, followed by four MI telephone follow up contacts at 1-, 2-, and 4-months post baseline."
16197982|NCT01410656|Behavioral|Telephone Implementation Intention|Telephone implementation intention counseling
16197983|NCT01410656|Behavioral|Self-completed implementation intention|Self-administered implementation intention intervention
16197984|NCT01410643|Other|Macronutrient Modification|reduced carbohydrate versus standard carbohydrate diet
16197985|NCT01410630|Diagnostic Test|FLT-PET/CT|Standard of Care
16197986|NCT01410630|Diagnostic Test|FDG-PET/CT|Standard of Care
16197987|NCT01410630|Drug|FLT|5 mCi IV
16197988|NCT01410617|Procedure|hemodialysis|3 sessions hemodialysis before CABG
16197989|NCT01410604|Drug|Metformin|Tablet of 500 mg metformin, oral every 12 hours (total metformin dose of 1 g/day) for 3 months.
16197990|NCT01410604|Drug|Placebo|Tablet of 500 mg oral placebo every 12 hours for 3 months.
16197991|NCT01410591|Device|8-mm covered stent group|Creating a shunt between hepatic vein and portal vein with a 8-mm covered stent by TIPS procedure.
16197992|NCT01410591|Device|10-mm covered stent group|Creating a shunt between hepatic vein and portal vein with a 10-mm covered stent by TIPS procedure.
16197993|NCT01410565|Drug|Apaziquone|Apaziquone 4 mg in 40 mL diluent
16197994|NCT01410565|Drug|Placebo|Placebo for Double Blind Phase
16197995|NCT01410552|Device|PARADYM DR model 8550; PARADYM CRT model 8750; PARADYM RF DR model 9550; PARADYM RF CRT model 9750; PARADYM RF CRT SonR model 9770|PARADYM ICD and CRT-d with PARAD+ algorithm available
16197996|NCT01410539|Device|OCT guided PCI|OCT guided PCI. Only thrombectomy in case of negative OCT findings (other than uncovered struts).
16197997|NCT01410539|Drug|OCT guided medical therapy|OCT guided medical therapy. Tailored antiplatelet therapy.
16197998|NCT01410513|Drug|SAR245409|Pharmaceutical form:capsule Route of administration: oral
16197999|NCT01410500|Drug|Carfilzomib|Carfilzomib was administered as an intravenous (IV) infusion over approximately 10 minutes on Days 1, 2, 8, 9, 15, and 16 of repeated 28-day cycles at a dose of 20 mg/m² on Days 1 and 2 of Cycle 1 and 27 mg/m² for all infusions thereafter until Cycle 12. For Cycle 13 and higher for those still receiving carfilzomib, the carfilzomib infusion schedule was abridged to Days 1, 2, 15, and 16 of each subsequent 28-day cycle. Carfilzomib treatment was continued until disease progression, diagnosis of a new malignancy, unacceptable toxicity, withdrawal of consent, or the study was terminated
16198000|NCT01410474|Biological|Meningococcal ACWY conjugate vaccine|All subjects received a single dose of Meningococcal ACWY conjugate vaccine and had blood draw at day 1 and day 29.
16198001|NCT01410461|Device|quantitive sensory testing|Mechanical pain threshold: Threshold will be assessed, by using the von Frey filaments. The lowest gram weight capable of inducing pain in two of three trials will be considered as a pain threshold Heat pain threshold (HPT): HPT will be measured using thermal sensory analyzer
16198002|NCT01410461|Device|Ultrasound testing|Morphological measures of the pelvic muscles: Using a 3D 4-8MHz abdominal probe ultrasound testing will be performed. The following parameters will be measured: (1) anteroposterior hiatal diameter; (2) lateral hiatal diameter; (3) levator ani thickness and length at 3 o'clock and 9 o'clock; (4) length of the obturator (5) length of the pubococcygeus muscle; (6) obturator thickness.
16198003|NCT01410448|Drug|Everolimus|Everolimus was provided in blisters containing 0.25 and 0.75 mg tablets and was taken orally.
16198004|NCT01410448|Drug|Mycophenolate sodium|Two 360 mg tablets were administered twice daily at 12-hour intervals. The tablets were swallowed whole in order to maintain the integrity of the enteric coating.
16198005|NCT01410448|Drug|Cyclosporine|Cyclosporine was supplied as blisters containing 100 mg, 50 mg, 25 mg and 10 mg soft-gelatin capsules and was administered orally.
16198006|NCT01410448|Drug|Steroids|Steroids were administered according to local clinical practice.
16198007|NCT01410435|Drug|Monofer|Infusion according to current HB level
16198008|NCT01410409|Other|Neuromuscular training (NEMEX-TJR)|60min. of neuromuscular training two times a week for 3 months (12 weeks) using the neuromuscular training program called NEMEX-TJR.
16198009|NCT01410409|Drug|Paracetamol|1 g x 4/day
16198010|NCT01410409|Drug|Burana|400 mg x 3/day for three weeks
16198011|NCT01410409|Drug|Pantoprazol|20mg x 1/day for three weeks
16198012|NCT01410409|Behavioral|Dietary counseling|For participants with a BMI equal to or >25. The dietitian initiates a 3-month intervention that provides instruction and guidance in relation to diet and plans the number of visits according to the individual participant needs.
16198013|NCT01410409|Behavioral|Patient education|"The aim is to strengthen the participant's involvement in the treatment, so the participant will be in a position to handle, master and act reasonable in relation to their knee OA. This aspect of the intervention is based on principles from The Chronic Disease Self-Management Program, Lær at leve med kronisk sygdom (Learn to live with chronic illness) by The National Board of Health, Denmark and Artrosskolan Spenshult in Sweden."
16198014|NCT01410409|Procedure|TKR|Surgical treatment with insertion of total knee replacement following standard procedures.
16198015|NCT01410409|Other|Insoles|"The position of the knee is assessed using Single Leg Mini Squat. On the basis of this test it is decided which of two types of insoles (Formthotics System) the participant should have (neutral with a lateral wedge or neutral).
~The participants will be advised to use the insoles in all shoes."
16198016|NCT01410383|Drug|Placebo|Tablets taken daily
16198017|NCT01410383|Drug|Eprotirome|Tablets taken daily
16198018|NCT01410383|Drug|Eprotirome|Tablets taken daily
16198019|NCT01410370|Radiation|6MV-X ray|3Gy/time, 5 times/week, a total of 10 times
16198020|NCT01410370|Drug|Endostar|7.5mg/m2/d, continuous infusion, in parallel with radiotherapy
16198021|NCT01410357|Behavioral|Targeted Training in Illness Management (TTIM)|This intervention blends psychoeducation, problem identification/goal-setting, behavioral modeling and reinforcement via use of Peer Educators, and health care linkage, has been adapted to the primary care setting and targeted for SMI-DM participants. Generalizability is enhanced with relatively brief in-person participation requirements and by utilizing professional staff typically found in primary care. TTIM will stress information sharing that is accessible to participants, and through a collaborative process, foster motivation for SMI-DM self-management.
16198022|NCT01410344|Drug|Fludarabine and Busulfan|"RIC Regimen (Flu/Bu): Fludarabine total dose: 120-180 mg/m^2, Busulfan: ≤ 8 mg/kg PO or 6.4 mg/kg IV). Recommended regimen:
~Days -6 to -2: Flu (30 mg/m^2/day, total dose of 150 mg/m^2)
~Days -5 to -4: Busulfan (4mg/kg/day PO or 3.2 mg/kg IV, 130 mg/m^2/day, total dose of 8 mg/kg PO or 6.4 mg/kg IV, or 260 mg/m^2 IV, respectively)
~Patients with a creatinine clearance of 40-70 ml/min (measured or calculated) should have a 20 percent dose reduction in Fludarabine dosage.
~Busulfan will be dosed according to the recipient's ideal body weight (IBW), unless the patient weighs more than 125 percent of IBW, in which case the drug will be dosed according to the adjusted IBW."
16198023|NCT01410344|Drug|Fludarabine and Melphalan|"RIC Regimen (Flu/Mel): Fludarabine total dose: 120-180 mg/m^2, Melphalan total dose: less than or equal to 150 mg/m^2. Recommended regimen:
~Days -5 to -2: Flu (30mg/m^2/day, total dose of 120 mg/m^2)
~Day -1: Mel (140mg/m^2)
~Patients with a creatinine clearance of 40-70 ml/min (measured or calculated) should have a 20 percent dose reduction in Fludarabine dosage."
16198024|NCT01410344|Drug|Busulfan and Fludarabine|"MAC Regimen (Bu/Flu): Fludarabine total dose: 120-180mg/m^2 Busulfan total dose less than or equal to 16mg/kg PO or 12.8 mg/kg IV. Recommended regimen:
~Days -5 to -2: Busulfan (4 mg/kg/day PO with Bu Css 900 plus/equal to 100 ng/mL (or per institutional standard), 3.2 mg/kg/day IV or 130 mg/m^2/day IV; total dose of 16 mg/kg, 12.8 mg/kg or 520 mg/m^2, respectively)
~Days -5 to -2: Flu (30 mg/m^2/day, total dose of 120 mg/m^2)
~Patients with a creatinine clearance of 40-70 ml/min (measured or calculated) should have a 20 percent dose reduction in Fludarabine dosage.
~Busulfan will be dosed according to the recipient's ideal body weight (IBW), unless the patient weighs more than 125 percent of IBW, in which case the drug will be dosed according to the adjusted IBW."
16198025|NCT01410344|Drug|Cyclophosphamide and Total Body Irradiation|"MAC Regimen (Cy/TBI): Cyclophosphamide total dose: 120 mg/kg, Fractionated TBI total dose: 1200-1420 cGy Recommended regimen:
~Days -7 to -4: TBI (total dose of 1200-1420 cGy)
~Days -3 to -2: Cy (60 mg/kg/day, total dose of 120 mg/kg)
~Cyclophosphamide will be dosed according to the recipient's ideal body weight (IBW), unless the patient weighs less than IBW, in which case the drug will be dosed according to the actual body weight."
16198026|NCT01410331|Biological|JVS-100(4 mg) or placebo/8 injections|4 mg of JVS-100 or placebo delivered in 8 injections
16198027|NCT01410331|Biological|JVS-100(8 mg) or placebo/8 injections|8 mg of JVS-100 or placebo delivered in 8 injections
16198028|NCT01410331|Biological|JVS-100(8 mg) or placebo/16 injections|8 mg of JVS-100 or placebo delivered in 16 injections
16198029|NCT01410331|Biological|JVS-100(16 mg) or placebo/16 injections|16 mg of JVS-100 or placebo delivered in 16 injections
16198030|NCT01410292|Other|GI and fiber meals|meals with different fiber content and glycemic index
16198031|NCT01410292|Other|meals|four different meal regarding GI and fiber content
16198032|NCT01410279|Other|Inspiratory muscle training|The load is adjusted weekly in thirty percent of maximal inspiratory pressure of the subject.
16198033|NCT01410266|Other|Alternative follow-up|Alternative follow-up consists of a self-administered semi-quantitative pregnancy test designed to measure urine beta-hCG levels, and a self-administered questionnaire consisting of 7 questions. Results of both are reviewed by the provider to determine if in-clinic follow-up is needed.
16198034|NCT01410253|Other|Combination of four techniques of physiotherapy|The patients receive conventional physiotherapy, expiratory positive airway pressure, inspiratory muscle training and physical exercise. Twice daily for seven days
16198035|NCT01410253|Other|Combination of three techniques of physiotherapy|Patients receive conventional physiotherapy, expiratory positive airway pressure and physical exercise. Twice daily for seven days
16198036|NCT01410253|Other|Combination of two techniques of physiotherapy|Patients receive conventional physiotherapy,expiratory positive airway pressure respiratory muscle training. Twice daily for seven days
16198037|NCT01410253|Other|standard therapy|Patients receive conventional physiotherapy and expiratory positive airway pressure. Twice daily for seven days
16198038|NCT01410240|Procedure|Standard of Care|Conventional hemostatic techniques, such as cautery and manual compression, will be used.
16198039|NCT01410240|Drug|FLOSEAL Hemostatic Matrix + Standard of care|"FLOSEAL will be applied topically to areas of the knee where bleeding is observed (e.g. cut bone surfaces, subcutaneous tissue, posterior joint capsule, synovial tissue, medial and lateral gutters, branches of the genicular vessels, and suprapatellar pouch) and will occur intraoperatively. Sufficient amounts of FLOSEAL will be applied quickly using the provided applicators, followed by immediate approximation with a damp gauze, lap pad or sponge for approximately 2 minutes.
~+ Standard of care: conventional hemostatic techniques, such as cautery and manual compression, will be used"
16198040|NCT01410227|Biological|Recombinant von Willebrand factor (rVWF)|Intravenous administration
16198041|NCT01410227|Drug|Placebo|Syringe supplied with physiologic saline solution for infusion
16198042|NCT01410227|Biological|Recombinant factor VIIII (rFVIII)|Intravenous administration
16198043|NCT01410214|Drug|Erlotinib|In the adjuvant treatment phase, erlotinib 150 mg/day taken orally for 2 years or till disease progression or unacceptable toxicity.
16198044|NCT01410214|Drug|vinorelbine/cisplatin|In the adjuvant treatment phase, patient will receive vinorelbine 25mg/m2 IV on day 1 and day 8, and cisplatin 25mg/m2 on day 1 and day 2 and day 3, of a 3-week schedule for 4 cycles or till disease progression or unacceptable toxicity.
16198045|NCT01410201|Drug|Dexamethasone Intravitreal Implant|Half of the study participants (15 out of 30) will receive one - Dexamethasone Intravitreal Implant 0.7 mg.
16198046|NCT01410188|Drug|OPA-6566|OPA-6566, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)
16198047|NCT01410188|Drug|Placebo|Placebo, 2 dosing schedules (one drop once per day for 2 weeks and twice per day for 2 weeks)
16198048|NCT01410188|Drug|Latanoprost|Latanoprost (one drop once per day for 4 weeks)
16198049|NCT01410175|Device|Conventional scalpel|Use of conventional scalpel to incise the skin and subcutaneous layers.
16198050|NCT01410162|Drug|Tacrolimus|tacrolimus extended release capsules vs Prograf
16198051|NCT01410149|Other|PAV|Proportional Assist Ventilation will be used to ventilate the patient for a 24 hour period
16198052|NCT01410149|Other|PSV|Pressure Support Ventilation will be used to ventilate the patient for a 24 hour period
16198053|NCT01410149|Other|ACV|Assist Control Ventilation will be used to ventilate the patient for a 24 hour period
16198054|NCT01410136|Procedure|Chondrofix Osteochondral Allograft|Allogeneic, cylindrical, decellularized, osteochondral graft composed of hyaline cartilage and bone
16198055|NCT01410123|Other|Integrated Stepped Care (ISC)|"At risk drinking:
~Step 1: Brief negotiated interview (BNI) + booster; Step 2: Motivational Enhancement Therapy; Step 3: Addiction Physician Management + Alcohol pharmacotherapy
~Alcohol abuse/dependence:
~Step 1: Addiction Physician Management + Alcohol Pharmacotherapy; Step 2: Motivational Enhancement Therapy; Step 3: Detoxification and aftercare
~Moderate Alcohol + Liver Disease:
~Step 1: Brief Negotiated Interview (BNI)+ booster; Step 2: Motivational Enhancement Therapy; Step 3: Addiction physician management + alcohol pharmacotherapy."
16198056|NCT01410123|Other|Treatment as Usual|The TAU arm will receive a handout with alcohol information embedded within general health-related information (exercise, smoking cessation, and flu vaccination) and standard care as provided by their treating physician. All patients will have access to a NIAAA informational website.
16198057|NCT01410110|Behavioral|Cognitive Training + Work Therapy|Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy
16198058|NCT01410110|Behavioral|Work Therapy|20 hours per week of work therapy
16198059|NCT01410097|Behavioral|Lifestyle intervention|Intensive Lifestyle Intervention that includes diet, physical activity, and behavior modification. The goal of the ILI intervention was for individuals to achieve and maintain a loss of at least 7% of initial body weight.
16198060|NCT01410097|Behavioral|Diabetes Support Education|It offers an educational program to participants including developing support groups. Providing such benefits helps retain these participants in the trial.
16198061|NCT01410084|Dietary Supplement|Vitamin D3|100,000 IU vitamin D3 once monthly for 5 months
16198062|NCT01410084|Dietary Supplement|Vitamin E|400 IU vitamin E once monthly for 5 months
16198063|NCT01410058|Dietary Supplement|Moringa oleifera|leaf powder, 1.85g once daily, hard gelatin capsules
16198064|NCT01410058|Drug|Efavirenz 600mg|Efavirenz 600mg based regimen
16198065|NCT01410058|Drug|Nevirapine 200Mg Oral Tablet|Nevirapine 200mg based regimen
16198110|NCT01409603|Drug|Naproxen|oral
16198111|NCT01409590|Behavioral|Exercise program|Homogenous exercise program in local fitness centers
16198066|NCT01410045|Procedure|Ovariectomy|Ovarian cryopreservation has been used in an effort to preserve fertility in patients undergoing treatments which lead to premature and severe ovarian insufficiency.
16198067|NCT01410032|Procedure|Plate fixation|Reconstruction plate
16198068|NCT01410032|Procedure|ESIN|ESIN (Elastic Stable Intramedullary Nailing)
16198069|NCT01410019|Other|Gene transfer|Single infusion of autologous CD34+ cells transduced with the self-inactivating (SIN) GAMMARETROVIRAL vector pSRS11.EFS.IL2RG.pre
16198070|NCT01409993|Drug|Sildenafil|Sildenafil 25 mg by mouth three times a day for three months
16198071|NCT01409993|Drug|Placebo|Matching placebo three times a day for three months
16198072|NCT01409993|Diagnostic Test|Hyperglycemic clamp|Subjects with prediabetes will have a baseline hyperglycemic clamp (Aim 1) and then receive sildenafil or placebo for 3 months. Another hyperglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.
16198073|NCT01409993|Diagnostic Test|Euglycemic clamp|Subjects with prediabetes will have a baseline euglycemic clamp (Aim 2) and then receive sildenafil or placebo for 3 months. Another euglycemic clamp will be performed followed by another 3 months off drug and an oral glucose tolerance test.
16198074|NCT01409928|Device|LAP-BAND (Allergan, Inc.)|Laparoscopic placement of adjustable gastric banding system for the treatment of severe obesity.
16198075|NCT01409915|Drug|Sagramostim|5 subjects 250 mcg /m2/day Leukine subcutaneously for 5 days/week for three weeks. Data and Safety Monitoring Board will then review data and recommend whether to continue at the same current recommended dose for additional subjects or to reduce the dose by half if excessive leukocytosis occurs
16198076|NCT01409915|Drug|Saline -- placebo comparator|subcutaneous injection
16198077|NCT01409889|Behavioral|Diabetes Prevention Program|
16198078|NCT01409889|Behavioral|Healthy Living Program|
16198079|NCT01409876|Radiation|brachytherapy|interstitial image- guided PDR/HDR brachytherapy
16198080|NCT01409863|Procedure|laser and standard diamond fraise dermabrasion|standard dermabrasion, CO2 laser resurfacing
16198081|NCT01409850|Device|Aqualizer|The Aqualizer is a soft splint with water-filled pads.
16198082|NCT01409850|Device|Soft splint|
16198083|NCT01409837|Drug|Lisinopril|"The two groups of patients, A and B, were randomly allocated treatments in a double-blind fashion. Group A was started on the coded drug DY1 while group B was started on the coded drug DZ2. Both DY1 and DZ2 were very identical in appearance. At week 96 the drugs were swopped between the groups such that group A changed to drug DZ2 while group B changed to drug DY1. There was no intervening washout period. The codes were concealed until after the data analysis."
16198084|NCT01409824|Other|CDSS|Clinical Decision Support System
16198085|NCT01409811|Drug|zoledronic acid|Given IV
16198086|NCT01409811|Other|laboratory biomarker analysis|Correlative studies
16198087|NCT01409811|Procedure|therapeutic conventional surgery|Undergo definitive lumpectomy or mastectomy
16198088|NCT01409772|Drug|Ethanol Lock|Ethanol Lock
16198089|NCT01409759|Procedure|Perforator based interposition flap|The flap is designed based on a selected perforator and locally available, preferably normal skin adjacent to the burn scar contracture. The flap consists of skin and underlying subcutaneous tissue. Based on the pre-operative defined perforator, the required length and width and the available preferable normal skin, a design for the perforator flap is made.
16198090|NCT01409733|Device|TACE using Drug Eluting Beads loaded with Doxorubicin|100-300 microns DC Beads loaded with Doxorubicin (75mg of Doxorubixcin per vial)
16198091|NCT01409720|Other|exercise|tailored isometric physical exercise
16198092|NCT01409707|Behavioral|Trauma-focused exposure therapy|cognitive behavioral therapy for PTSD
16198093|NCT01409707|Behavioral|Motivational enhancement + trauma-focused exposure therapy|Cognitive behavioral therapy for PTSD
16198094|NCT01409707|Behavioral|Healthy lifestyles sessions|
16198095|NCT01409694|Drug|Memantine|Memantine is administered to all participants according to the usual strategy, with upward titration of 5 mg per week during the first three weeks to reduce the risk of side effects. The final dosage is 20 mg per day, with no subsequent modification of dosage or specialty during the trial.
16198096|NCT01409694|Drug|Vitamin D|Subjects receive Vitamin D supplementation (cholecalciferol 100,000 IU, drinking solution, 2 mL vial) at a rate of 1 drinking vial of 100,000 IU cholecalciferol every month. In brief, the total dose is 600,000 IU over the duration of the study starting with one vial at the time of inclusion, then at week(W) 4, W8, W12, W16 and W20. The dose of vitamin D supplementation will not be adjusted except in case of an adverse event such as hypercalcemia. In this case, vitamin D supplementation is stopped and the participant is released prematurely from the study.
16198097|NCT01409694|Drug|Vitamin D placebo|Subjects receive Vitamin D placebo (drinking solution, 2mL vial) at a rate of 1 drinking vial every month. In brief, the subjects start with one vial at the time of inclusion, then at week(W)4, W8, W12, W16 and W20. The placebo drinking solution contains all the excipients present in the Vitamin D vial.
16198098|NCT01409668|Dietary Supplement|L. Amylovorus|L. Amylovorus
16198099|NCT01409668|Dietary Supplement|L. Fermentum|L. Fermentum
16198100|NCT01409655|Behavioral|cognitive-behavioral therapy|. Reinforcement for medication-taking will be wired to debit cards that patients will be given to receive the payments. This contingent reinforcement of medication-taking will be coupled with twelve sessions of cognitive-behavioral therapy (CBT) conducted by phone, also assisted by the website which will generate CBT-related text messages, reminders and scheduling information from a menu of choices negotiated by the patient and therapist.
16198101|NCT01409642|Behavioral|Individual Child CBT|12 sessions of individual child focused cognitive behavior therapy with a parent component
16198102|NCT01409642|Behavioral|Positive Family Interaction Therapy|Six sessions of family-focused treatment for childhood OCD administered as an adjunct to 12 sessions of child CBT
16198103|NCT01409642|Behavioral|Positive Family Interaction Therapy|Positive Family Interaction Therapy (PFIT) is a 6-session treatment designed to be used as an adjunct to standard child CBT in cases where OCD is complicated by challenging family dynamics.
16198104|NCT01409629|Behavioral|Computer game|Participants will play a computer game
16198105|NCT01409616|Drug|darexaban|oral
16198106|NCT01409616|Drug|darexaban (double dose)|oral
16198107|NCT01409616|Drug|Acetyl Salicylic Acid|oral
16198108|NCT01409616|Drug|clopidogrel|oral
16198112|NCT01409590|Behavioral|Diet|Weigh loss diet program prescribed by a professional nutritionist
16198113|NCT01409564|Drug|Cilostazol|Cilostazol 100mg bid per day will be administered orally and the period is total 24 weeks. The first week is a period for increasing the quantity, and during this period, cilostazol 50mg bid per day will be administered orally.
16198114|NCT01409564|Drug|Placebo|Placebo with similar shape and color to cilostazol 100mg bid per day will be administered orally and the period is total 24 weeks. The first week is a period for increasing the quantity, and during this period, placebo 50mg bid per day will be administered orally.
16198115|NCT01409551|Procedure|VATS hyperthermic chemoperfusion|VATS, adhesiolysis, hyperthermic chemoperfusion (with a pump machine)
16198116|NCT01409551|Procedure|Bedside talc slurry pleurodesis|Bedside tube thoracostomy under local anesthesia. Bedside talc slurry pleurodesis.
16198117|NCT01409538|Other|Placebo Instructions|There is no intervention in this study. It is not a Clinical Trial. The study is an investigation of the neural basis of placebo analgesia.
16198118|NCT01409538|Other|Control condition|"This protocol represents an investigation of the neural mechanisms of placebo analgesia. As such, it does not represent the traditional clinical trial design. Instead the active intervention is a placebo, and the comparison condition is a no-intervention control."
16198119|NCT01409512|Procedure|ECG recording|At baseline and following 3 months on anticholinergic medications patients, ECG recording will be conducted.
16198120|NCT01409499|Procedure|hepatic resection|palliative hepatectomy followed by sorafenib
16198121|NCT01409499|Procedure|transcatheter hepatic arterial chemoembolization|TACE followed by sorafenib
16198122|NCT01409499|Drug|sorafenib|sorafenib monotherapy, 400mg Bid, continuously
16198123|NCT01409486|Other|Drawing blood spots from Newborns|Dry blood spots would be taken for determination of Alpha Glucosidase activity using LC-MS-MS
16198124|NCT01409473|Radiation|Prostate SBRT with concurrent boost to intraprostatic lesion(s)|40 Gy in 5 fractions to prostate for low-risk and 45 Gy in 5 fractions to prostate for intermediate-risk patients, and 50 Gy in 5 fractions to intraprostatic lesion(s), delivered over 10-14 days on preferably every other day.
16198125|NCT01409460|Procedure|Oburator Nerve block|Use of selective pain block.
16198126|NCT01409460|Procedure|Sham Injection in pectineus muscle.|Five minutes after the sham block pain was assessed in these patients. If pain score was 5 or greater a true obturator nerve block was performed on these patients.
16198127|NCT01409447|Device|Biphasic osteochondral composite|We had previously developed a biphasic osteochondral composite as the construct for chondrocyte implantation. We further conducted this feasibility study of such device to treat patients with osteochondral lesion of the knee joints.
16198128|NCT01409434|Drug|Oral Glucose Tolerance Test|Administration of 75 gram oral glucose load and three plasma glucose measurements (including baseline).
16198129|NCT01409421|Behavioral|motivational interviewing|counseling intervention
16198130|NCT01409421|Behavioral|three phone calls to remind patients to take their eye drops|reminder phone calls
16198131|NCT01409408|Drug|Aliskiren|300 mg of aliskiren daily for 8 weeks.
16198132|NCT01409408|Drug|Amlodipine|Amlodipine 5 mg daily for 8 weeks.
16198133|NCT01409395|Drug|Metformin and nizatidine|Subjects will be given a single oral dose of 850 mg of metformin and a single oral dose of 600 mg of nizatidine
16198134|NCT01409395|Drug|Metformin|Subjects will be given a single oral dose of 850 mg of metformin
16198135|NCT01409382|Behavioral|Daily brisk walking plus a carbohydrate-restricted diet|Daily brisk walking at moderate speed (4 km/h) for at least 40 minutes per day, 7 days a week. Patients will be recommended to avoid high-glycemic index meals (such as snacks, candies, fiber-free juices and sugar-sweetened beverages), and to eat at least two daily servings of meat, poultry, fish (e.g. 2 g/kg) or other protein-rich food, starting when they decided to get pregnant and continuing until delivery. Recommendations will be emphasised at every appointment. Antidepressants will not be discontinued in both groups, but patients on paroxetine and sertraline, will be switched to fluoxetine.
16198136|NCT01409369|Drug|RO4995819|single oral dose
16198137|NCT01409369|Drug|activated charcoal|orally 3 times daily, Days 1-7
16198138|NCT01409356|Behavioral|Diet + exercise|Program of dietary counselling by dietists, who will periodically follow-up the patient to achieve weight loss; moreover a fitness professional will instruct and train the patients twice a week to enhance their physical activity. A step counter will be also given to all participants and daily step count will be recorded. The duration of diet+exercise is 4 months from baseline HVPG measurement.
16198139|NCT01409343|Drug|TrasGEX™|Patients received TrasGEX intravenously every 3 weeks until disease progression in doses of 12-720 mg in a three-plus-three dose escalation design, including an expansion cohort at the highest dose.
16198140|NCT01409330|Dietary Supplement|diet intervention|8-week diet lacking red meat, but containing increased fibers and coffee (verum) versus standard recommendation (control) eating red meat.
16198141|NCT01409317|Device|Deep Transcranial Magnetic Stimulation|DTMS will be administered according to the following parameters: 18 Hz in 84 trains of 2 seconds duration, with 20 seconds inter-train interval (3,024 pulses per session) at 120% of the resting motor threshold
16198142|NCT01409317|Device|Repetitive Transcranial Magnetic Stimulation|rTMS will be administered according to the following parameters: 18 Hz in 84 trains of 2 seconds duration, with 20 seconds inter-train interval (3,024 pulses per session) at 120% of the resting motor threshold.
16198143|NCT01409304|Device|Deep Transcranial Magnetic Stimulation (DTMS)|DTMS will be administered according to the following parameters: 18 Hz in 84 trains of 2 seconds duration, with 20 seconds inter-train interval (3,024 pulses per session) at 120% of the resting motor threshold.
16198144|NCT01409278|Procedure|Ropivacaine infiltration and saline infusion.|50ml ropivacaine 0.2% with keterolac 15mg infiltration followed by normal saline infusion at 5ml per hour
16198145|NCT01409278|Procedure|Ropivacaine infiltration and infusion.|50 ml infiltration of ropivacaine 0.2% and ketorolac 15mg admixture followed by ropivacaine 0.2 % at 5ml per hour infusion for 48 hours.
16198146|NCT01409278|Procedure|Normal Saline|50ml of normal saline infiltration followed by normal saline infusion at 5ml per hour
16198147|NCT01409239|Drug|Intravenous insulin|24 hr IV insulin administered according to hospital guideline
16198148|NCT01409239|Drug|Subcutaneous Insulin|basal bolus insulin using carb counting technique and insulin analogues
16198231|NCT01408641|Drug|Placebo|Placebo capsules without topiramate
16198149|NCT01409226|Device|3.0-T MRI|Participants undergo MRI prior to biopsy.
16198150|NCT01409226|Procedure|biopsy|Participants undergo breast biopsy after 3.0-T MRI.
16198151|NCT01409200|Drug|Antiandrogen Therapy|Given per standard of care
16198152|NCT01409200|Drug|Axitinib|Given PO
16198153|NCT01409200|Procedure|Radical Prostatectomy|Undergo radical prostatectomy
16198154|NCT01409200|Procedure|Regional Lymph Node Dissection|Undergo pelvic lymph node dissection
16198155|NCT01409187|Drug|Ipilimumab|Starting dose 2 mg/kg by vein on day 1 of each of the four 3-week cycles (Phase II is maximum tolerated dose (MTD) from Phase I). During Consolidation and Maintenance phases one dose every 12 weeks.
16198156|NCT01409187|Drug|Interferon|5 million U/m2 subcutaneously daily for 5 days starting day 1 of each Induction and Consolidation cycle.
16198157|NCT01409187|Drug|Interleukin-2 (Aldesleukin)|9 million IU/m^2 daily by vein by continuous infusion for 4 days (total of 96 hours, days 2-5) starting day 2 of each Induction and Consolidation cycle.
16198158|NCT01409174|Drug|Ipilimumab|"Phase I Starting dose: 1 mg/kg by vein over 90 minutes on Day 1 of each 3 week cycle for Induction 12 weeks, then Day 1 of Cycle 1 for Consolidation 12 weeks and Day 1 of each 12 week cycle in Maintenance.
~Phase II dose: Maximum tolerated dose (MTD) from Phase I."
16198159|NCT01409174|Drug|Temozolomide|200 mg/m^2 by mouth 1 time a day on Days 2-5 of each Induction cycle (four 3 week cycles).
16198160|NCT01409174|Drug|Cisplatin|25 mg/m^2 by vein over 1 hour on Days 2-4 of each Induction cycle (four 3 week cycles).
16198161|NCT01409174|Drug|Interferon Alfa-2b|5 million U/m2 subcutaneously on Days 2-6 of each 3 week Induction cycle (four 3 week cycles) and each 4 week Consolidation cycle (three 4 week cycles).
16198162|NCT01409174|Drug|Interleukin-2|9 million IU/m^2 by vein as a continuous infusion on Days 2-5 of each 3 week Induction cycle (four 3 week cycles) and each 4 week Consolidation cycle (three 4 week cycles).
16198163|NCT01409161|Drug|Arsenic Trioxide|Given IV
16198164|NCT01409161|Drug|Gemtuzumab Ozogamicin|Given IV
16198165|NCT01409161|Other|Laboratory Biomarker Analysis|Correlative studies
16198166|NCT01409161|Drug|Tretinoin|Given PO
16198167|NCT01409148|Biological|124I-labeled monoclonal antibody Mu 11-1F4|Single infusion of radiolabeled antibody: 2mCi (1 mg)
16198168|NCT01409135|Drug|AGS-22M6E|IV Infusion
16198169|NCT01409135|Drug|ASG-22CE|IV Infusion
16198170|NCT01409122|Drug|15 mg sodium nitrite inhalation solution|15 mg sodium nitrite inhalation solution Q8H
16198171|NCT01409122|Drug|90 mg sodium nitrite inhalation solution|90 mg sodium nitrite inhalation solution Q8H
16198172|NCT01409122|Drug|45 mg sodium nitrite inhalation solution|45 mg sodium nitrite inhalation solution Q8H
16198173|NCT01409122|Drug|120 mg sodium nitrite inhalation solution|120 mg sodium nitrite inhalation solution or placebo Q8H
16198174|NCT01409122|Drug|25% MTD sodium nitrite inhalation solution|Multiple oral doses of 20 mg sildenafil will be administered open-label Q8H to a single cohort of eight subjects on Days 1 to 6. A single dose of sodium nitrite inhalation solution equal to 25% of the maximum tolerated dose (MTD) identified in Part A (or placebo) will be administered on Day 4, a single dose equal to 50% of the MTD (or placebo) will be administered on Day 5, and a single dose equal to 100% of the MTD (or placebo) will be administered on Day 6.
16198175|NCT01409096|Drug|Pregnenolone|Pregnenolone is a naturally occurring neurosteroid that is synthesized from cholesterol in the adrenal glands and central nervous system.
16198176|NCT01409096|Drug|Placebo|Inactive ingredient matching the active medication in appearance.
16198177|NCT01409083|Device|intravenous sodium bicarbonate|Dilted sodium bicarbonate 2.1%
16198178|NCT01409044|Other|Music|"Music listening for the treatment group. Music is from MusicCure selection Dreams. Outocmes are compared to control group who receives no music. Subjects are randomized Post-operatively."
16198179|NCT01409031|Drug|Intravenous Sildenafil|0.4 mg/kg bolus, followed by a continuous infusion of 1.6 mg/kg/day or an equivalent volume of placebo (D5W); infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days.
16198180|NCT01409031|Other|Placebo|An equivalent volume of placebo (D5W)infusion will be initiated as a bolus over 3 hours, followed by a controlled continuous infusion for up to 7 days.
16198181|NCT01409018|Drug|Itraconazole|pharmacokinetics
16198182|NCT01409005|Drug|Gemcitabine and UFTE chemotherapy|"Gemcitabine : 800 mg/m2 mix with 150mL of normal saline (i.v.) over 30 min on Days 1, 8 and 15
~UFTE : 200mg/m2 PO q 8 hr, Days 1~21
~Interval: every 4 weeks"
16198183|NCT01408992|Procedure|Audiometry|Standard hearing test performed by audiologists
16198184|NCT01408992|Other|Thai-Five Minute Hearing Test|All subjects will be interviewed with Thai-Five Minute Hearing Test
16198185|NCT01408979|Drug|Magnesium sulfate 12 hours|Magnesium sulfate, 1g/h, (10% solution), for 12 hours
16198186|NCT01408979|Drug|Magnesium sulfate 24 hours|Magnesium sulfate, 1g/h, (10% solution), for 24 hours
16198187|NCT01408966|Dietary Supplement|DarkChocolate|Dark chocolatee 0.55 g/kg of body weight was given together with the test meal in sitting position after the baseline measurement of HVPG. The meal + chocolate was ingested in 8 minutes.
16198188|NCT01408966|Dietary Supplement|WhiteChocolate|White chocolate 0.63 g/kg white chocolate (Lindt Excellence Natural Vanilla, Lindt & Sprüngli España) in an iso-caloric and iso-volumetric proportion adjusted to body weight was used as a control
16198189|NCT01408953|Biological|bevacizumab|"Bevacizumab will be diluted with 0.9% Sodium Chloride to achieve a concentration of 1 mg/0.3 ml. Bevacizumab will be injected inside ONE keloid tissue to result in a visual expansion of the keloid. Only 1 mg of bevacizumab is injected inside ONE keloid. The injections will be repeated every 14 days. Patients will receive maximum of 12 injections only.
~A log will be kept for each patient indicating the date and the dose of bevacizumab that was delivered to each patient."
16198190|NCT01408927|Other|Thienopyridine resistance testing|Thienopyridine resistance will be measured by flow cytometry of vasodilator-stimulated phosphoprotein (VASP) phosphorylation, and/or VerifyNow P2Y12 assay, and/or the Chrono-Log Lumi-Aggregometer, and/or the PlaCor PRT 7000 platelet reactivity assay.
16198191|NCT01408927|Other|Aspirin resistance testing|Aspirin resistance will be measured by the VerifyNow aspirin resistance assay.
16198192|NCT01408927|Other|Genetic polymorphism assessment|The presence of minor alleles in selected single nucleotide polymorphisms (SNPs) as measured by the Applied Biosystems Open Array system.
16198193|NCT01408914|Drug|Higher-Dose Rifampin|The intervention phase of this trial will last 8 weeks. During that time, subjects will receive the following companion drugs: isoniazid (INH, 5 mg/kg/day), ethambutol (EMB, 20 mg/kg/day), and pyrazinamide (PZA, 25 mg/kg/day), pyridoxine (50 mg), the standard doses used in treatment. Subjects will also be randomized to receive one of the following weight-based doses of the study drug, rifampin (RIF): 10 mg/kg/day (standard dose, control), 15 mg/kg/day (intervention 1), 20 mg/kg/day (intervention 2). All patients will receive at least standard dose of RIF, the efficacy of which in multidrug-treatment for TB is well established. Placebo will be used to control only the additional RIF capsules provided in the intervention arms.
16198194|NCT01408901|Behavioral|Supervised Treadmill Exercise Therapy|Exercise intervention will be delivered three times weekly for 26 weeks. In the first week, participants will be asked to exercise 15 minutes per session (excluding rest periods). Walking exercise duration will be increased to 25 minutes minutes per session during week 2. Week 3 and 4 sessions will also be 25 minutes long, but the intensity will be increased either to produce leg symptoms or at a target rate of perceived exertion (RPE)of 12-14 on the Borg's 6-20 scale. For weeks 5-8, walking duration will be increased to 40 to 50 minutes while maintaining intensity. For weeks 9-26, exercise duration will continue to be 40 to 50 minutes but we will increase intensity up to a maximum of 4.0 miles per hour at 10% grade.
16198195|NCT01408901|Other|Health education sessions (Control)|Participants randomized to the attention control group will attend weekly one-hour educational sessions at Northwestern University for six months. These educational sessions are on topics of interest to the typical PAD patient and are led by physicians and other health care workers. Topics include Medicare Part D, nutritional supplements, C-reactive protein, and hypertension. Sessions do not include information about exercise.
16198196|NCT01408901|Drug|granulocyte macrophage colony stimulating factor (GM-CSF)|The dose of GM-CSF will be 250 ug/M^2 subcutaneously three times weekly for two weeks.
16198197|NCT01408888|Biological|LY2189265|Administered subcutaneously
16198198|NCT01408888|Drug|Sitagliptin|Administered orally
16198199|NCT01408875|Device|Low electrical myostimulation|The group of patients randomized for additional EMS will have 20 sessions of 1 hour electrical quadricipital myostimulation.
16198200|NCT01408862|Other|venous puncture|Blood for in vitro studies will be drawn
16198201|NCT01408849|Drug|Maytenus ilicifolia leaves infusion|2 g of powdered leaves in 150 mL of boiling water, 3 times a day, for 8 weeks
16198202|NCT01408849|Drug|Omeprazole|Standard therapy
16198203|NCT01408836|Procedure|Plasma exchange|Plasma exchange
16198204|NCT01408836|Drug|Intravenous methyl prednisolone|Intravenous methyl prednisolone
16198205|NCT01408836|Drug|Methyl prednisolone|methyl prednisolone
16198206|NCT01408810|Drug|Infliximab|5 mg/Kg, I.V. at weeks 0, 2, 6 and every 8 weeks thereafter
16198207|NCT01408797|Procedure|donor specific transfusion|before transplantation,200mL of donor whole blood will be transfused to the recipient
16198208|NCT01408797|Drug|MMF, Bortezomib|MMF and Bortezomib will be administered after donor specific transfusion
16198209|NCT01408797|Procedure|drugs added according to the immuno condition of the recipients|drugs (corticosteroid, MMF and/or CNI) will be added according to the recipients immuno event and donor specific antibody
16198210|NCT01408758|Other|Virtual Clinician Research Tool (VCRT)|The Virtual Clinician Research Tool (VCRT) will use Self-Determination Theory (SDT) to guide the process or style of how two national guidelines (one for hyperlipidemia, 1 for tobacco dependence)will be operationalized into a virtual format that patients can access online using any internet connected personal computer to develop their plan for change (in this project regarding tobacco or nutrition).
16198211|NCT01408758|Other|No VCRT, only physician counseling at visits|No intervention
16198212|NCT01408745|Device|Sternumfix|sternotomy closure with Sternumfix
16198213|NCT01408745|Procedure|steel wire|sternotomy closure with steel wire
16198214|NCT01408732|Drug|Sclerotherapy|3% Sodium tetradecyl sulfate (STS) is mixed with air at a ratio of 4 parts air to 1 part STS for injection into the affected vessels in the nose. Topical anesthetic is applied to the nasal mucosa prior to injections. Once the mixture is ready for injection, the needle is placed into the vessel, in a submucosal fashion, penetrating 1-2 mm, and very small quantities of foam are injected The amount of foam injected into each lesion varies between 0.1 cc to 0.25 cc. Individual injection amounts vary between lesions, patients and treatment sessions. No more than a total of 3 ml of solution is used in each session. During each session, several lesions can be treated, but the total amount of STS used does not exceed 3 cc.
16198215|NCT01408732|Other|Standard Treatment|Normal standard of care followed by Drug interevention
16198216|NCT01408719|Dietary Supplement|Control|Minimal beta-glucan
16198217|NCT01408719|Dietary Supplement|3g LMW beta-glucan|3grams beta-glucan
16198218|NCT01408719|Dietary Supplement|5g LMW beta-glucan|5 grams beta-glucan
16198219|NCT01408719|Dietary Supplement|3g HMW beta-glucan|3 grams of high molecular weight beta-glucan
16198220|NCT01408706|Device|Miller Air tip|Miller Enema Air Tip is inserted into rectum prior to simulation and each radiation treatment.
16198221|NCT01408706|Device|Radiadyne Immobilizer|Radiadyne Immobilizer is inserted into rectum prior to simulation and each radiation treatment
16198222|NCT01408693|Procedure|Trans-gluteal approach, CLAS|Classic lateral, trans-gluteal approach. Device: Cemented unipolar hip hemiarthroplasty for the treatment of femoral neck fractures
16198223|NCT01408693|Procedure|Anterior minimal invasive approach, AMIS|Minimal invasive Hueter anterior approach. Device: Cemented unipolar hip hemiarthroplasty for the treatment of femoral neck fractures
16198224|NCT01408680|Dietary Supplement|Coenzyme Q10|Wafer taken daily by mouth for duration of study, containing Coenzyme Q10 at 600 mg.
16198225|NCT01408680|Dietary Supplement|Coenzyme Q10|Wafer taken daily by mouth for duration of study, containing Coenzyme Q10 at 1200 mg.
16198226|NCT01408680|Dietary Supplement|Placebo|Wafer taken daily by mouth for duration of study, containing inactive ingredients. Wafer is indistinguishable from those wafers containing CoQ10.
16198227|NCT01408667|Drug|TRC150094|50 mg Tablets once a day
16198228|NCT01408667|Other|Placebo|Tablets once daily
16198229|NCT01408654|Behavioral|Peer Companionship|Peer companionship is provided at least four times per month over two years in the form of friendly visiting, supportive phone calls, and some instrumental support.
16198230|NCT01408641|Drug|Topiramate|Topiramate titrated over 6 weeks to 400mg or highest tolerated dose.
16198232|NCT01408628|Behavioral|Internet Insulin Education|"Offer and assess the safety and effectiveness of a synchronous (live) interactive 4-week Internet course designed to teach groups of type 2 diabetic patients to safely administer basal insulin without significant support from their usual source of diabetic management and to self-adjust the dose to achieve an HbA1c of < 7.0% using an established treat-to-target algorithm."
16198233|NCT01408615|Drug|corifollitropin alfa|100 or 150 microgram single subcutaneous injection
16198234|NCT01408602|Drug|MRC375|MRC 375 (enteric coated Tetracycline) 75mg 3 times a day for 24 weeks.
16198235|NCT01408602|Drug|Matching Placebo|Matching Placebo 3 times a day for 24 weeks. Early escape at week 16,20.
16198236|NCT01408602|Drug|MRC375 150mg|MRC375 (enteric coated Tetracycline) 150mg 3 times a day for 24 weeks
16198237|NCT01408589|Drug|Atomoxetine, Strattera|Atomoxetine at 0, 40, 60, 80 mg/day was given for 5 days, all subjects took two capsules per day for 5 days; all active dose groups received 40 mg/day for first 3 days and where then dose escalated to dosage group assigned.
16198238|NCT01408576|Drug|Epratuzumab|600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over eight 12-week treatment cycles
16198239|NCT01408576|Drug|Epratuzumab|1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over eight 12 week treatment cycles
16198240|NCT01408563|Drug|Fludarabine|30 mg/m2/day IV x 6 days
16198241|NCT01408563|Drug|Melphalan|100 mg/m2/day IV x 1 day
16198242|NCT01408563|Radiation|Total Body Radiation|200 cGy on Day 0
16198243|NCT01408563|Biological|Cord Blood|2 cord blood units IV
16198244|NCT01408550|Drug|NPB-01|Intravenous immunoglobulin
16198245|NCT01408550|Drug|Placebo|Physiological saline
16198246|NCT01408537|Biological|JEVAC|Each subject will receive 3 doses of JEVAC subcutaneously on Day 0, 1-4 weeks and a booster vaccination at one year. Each dose of JEVAC contains 0.5 mL. of inactivated Vero cell derived JE vaccine (Beijing P-3 strain).
16198247|NCT01408524|Drug|Diltiazem|2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence
16198248|NCT01408524|Drug|Labetalol|2.5 mg iv q 2-5 min for keeping SBP below 140 mmHg during the emergence
16198249|NCT01408511|Drug|Mapracorat|Application of the investigational product on the affected skin areas
16198250|NCT01408498|Drug|Testosterone|Topical administration of testosterone gel. Participants receive a one-time, single dose of 10 g of 1% testosterone gel.
16198251|NCT01408485|Device|Therapy™ Cool Flex™ Irrigated Ablation System|"The investigational components of the Therapy™ Cool Flex™ Irrigated Ablation System consist of:
~Therapy™ Cool Flex™ 4mm Irrigated Ablation Catheter
~IBI 1500T9 V1.43 RF Generator"
16198252|NCT01408472|Drug|NT-501 CNTF Implant|Single implantation of CNTF-secreting NT-501 device into one eye
16198253|NCT01408459|Dietary Supplement|Tomato Product|Motivational Telephone Counseling weekly
16198254|NCT01408459|Dietary Supplement|Control|No Motivational telephone Counseling
16198255|NCT01408446|Drug|Menthol|Capsule 48mg three times a day after meals 8 weeks
16198256|NCT01408446|Drug|Placebo|Capsule 48mg three times a day after meals 8 weeks
16198257|NCT01408433|Other|Single Embryo Transfer|single embryo transfer of a chromosomally normal embryo
16198258|NCT01408433|Other|Double embryo transfer|two (2) embryo transfer of untested embryos
16198259|NCT01408420|Procedure|MAP > 60 mmHg|During heart surgery a blood pressure with a MAP > 60 mmHg during extracorporeal circulation is used.
16198260|NCT01408407|Other|Aveeno cream|Apply cream on irradiated area twice a day
16198261|NCT01408407|Other|Alkagin paste|Apply Alkagin paste three times a day.
16198262|NCT01408394|Drug|Ecopipam immediate release form|Tablet containing 100 mg of the immediate release form of ecopipam
16198263|NCT01408394|Drug|90 mg controlled release form|This is the 90 mg controlled release form
16198264|NCT01408394|Drug|180 mg controlled release form|This is the 180 mg controlled release capsule
16198265|NCT01408381|Other|Intraarterial Infusion of Autologous Bone Marrow Mononuclear Cells|Autologous bone marrow-derived mononuclear cells will be infused by an intraarterial catheter into de ischemic limb. The number of infused cells will be 1x108, 5x108 and 1x109 low, intermediate and high dose in the arms respectively.
16198266|NCT01408368|Procedure|Bilateral subtotal thyroidectomy|The intervention consisted of bilateral subtotal thyroidectomy (leaving on both sides of the neck thyroid stumps of approximately 2 g of normal remnant tissue each).
16198267|NCT01408368|Procedure|Total thyroidectomy|The intervention consisted of total extracapsular thyroidectomy.
16198268|NCT01408355|Drug|PF-06273588|Intravenous, 50 microgram, single dose
16198269|NCT01408355|Drug|PF-06273588|Oral solution, 50 microgram, single dose
16198270|NCT01408342|Drug|Alemtuzumab and Rituximab|"Alemtuzumab 10 mg (5 mg/m2 in patients under 30 kg weight) subcutaneous days 1,2 and 3
~Rituximab 100 mg (50 mg/m2 in patients under 30 kg weight)intravenous days 4,11,18,25
~Cyclosporine 3 mg/kg starting day 21"
16198271|NCT01408329|Device|CVAC Device (Cyclic Variations in Altitude Conditioning)|A hypobaric hypoxia chamber
16198272|NCT01408316|Drug|PX-866|Volunteers in part 1 of the study will receive two single dose 8 mg treatments of PX-866 (one each of crystalline PX-866 tablets and amorphous PX-866 capsules) in Periods A and B, separated by at least seven days. Volunteers in part 2 of the study will receive two single dose 6 mg treatments of PX-866 (crystalline PX-866 tablets administered in either fed or fasted state), in Periods C and D, separated by at least seven days.
16198273|NCT01408303|Drug|Olive oil, 4g|Olive oil: 4 x 1 g capsule daily for 6 weeks + prescription statin
16198274|NCT01408303|Drug|omega-3-carboxylic acids, 2g|Epanova: 2 x 1 g capsule + olive oil 2 x 1 g capsule daily for 6 weeks + prescription statin
16198275|NCT01408303|Drug|omega-3-carboxylic acids, 4g|Epanova: 4 x 1 g capsule daily for 6 weeks + prescription statin
16198276|NCT01408290|Biological|Vaccination with FAB-3511|One 0.5 mL injection of FAB-3511 trivalent influenza vaccine containing 3.5μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.
16198277|NCT01408290|Biological|Vaccination with FAB-6011|One 0.5 mL injection of FAB-6011 trivalent influenza vaccine containing 6μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.
16198278|NCT01408290|Biological|Vaccination with FAB-9011|One 0.5 mL injection of FAB-9011 trivalent influenza vaccine containing 9μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.
16198372|NCT01407731|Genetic|protein expression analysis|
16198279|NCT01408290|Biological|Vaccination with FluvalAB|One 0.5 mL injection of FLUVAL AB trivalent influenza vaccine containing 15μgHA of seasonal A/H1N1, A/H3N2 and B influenza antigens.
16198280|NCT01408277|Biological|Santyl|2 mm Santyl applied once daily
16198281|NCT01408277|Procedure|Control|Standard Care
16198282|NCT01408264|Device|Conventional 0.035 guidewire|0.035 guidewire
16198283|NCT01408264|Device|Olympus Visiglide 0.025 guidewire|0.025 guidewire
16198284|NCT01408238|Biological|Four different concentrations of Secale cereale allergen extract, positive control and negative control|4 concentrations of Secale cereale allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm
16198285|NCT01408225|Procedure|tissue banking|tissue procurement for this protocol will occur at the time of initial diagnosis, during routine follow-up, or at the time of relapse.
16198286|NCT01408212|Procedure|Acupuncture treatment|"Acupuncture treatment will be performed by licensed doctors in Korean Medicine using 0.20 mm (diameter) X 0.30 mm (length) sized disposable acupuncture on seven to ten consecutive days after admission to the Korean Medicine Hospital of Pusan National University. At least two sessions and a maximum of five sessions of acupuncture therapy will be administered per day. Acupuncture points consist of common points and additional points selected for typical complaints common in patients under chemotherapy. These points are as follows.
~Common points: LI4 (bilateral), LU5 (bilateral), LU7 (bilateral), BL13 (bilateral), BL23 (bilateral), SP3 (bilateral), LU9 (bilateral), ST36 (bilateral) and CV22
~Additional points Nausea/vomiting PC6 (bilateral) Dyspepsia: CV12, LU6 (bilateral) Insomnia: Yintang, KI5 (bilateral) Pain: Ashi points (tender spots)"
16198287|NCT01408199|Drug|Lenalidomide|5 mg daily will be administered until the achievement of complete response, and then tapered progressively according to clinical response
16198288|NCT01408186|Drug|Rabeprazole|Rabeprazole 20 mg daily
16198289|NCT01408186|Drug|Famotidine|Famotidine 40mg daily
16198290|NCT01408173|Drug|NPC-11 for intravenous or oral administration.|NPC-11, Each vial (3mL) contains 60 mg caffeine citrate (equivalent to 30mg caffeine).
16198291|NCT01408160|Drug|Cytarabine|Given IV
16198292|NCT01408160|Biological|Deglycosylated Ricin A Chain-Conjugated Anti-CD19/Anti-CD22 Immunotoxins|Given IV
16198293|NCT01408160|Other|Laboratory Biomarker Analysis|Correlative studies
16198294|NCT01408160|Other|Pharmacological Study|Correlative studies
16198295|NCT01408147|Behavioral|Online postpartum weight control|The intervention group will be given access to an online weight loss program supplemented by monthly group meetings.
16198296|NCT01408134|Other|DE CT|Delayed scan (per VIVA protocol): The delayed scan will be performed 10 minutes after contrast second contrast bolus complete using axial acquisition at 100 kVp. Scan length will be limited to the cardiac structures.
16198297|NCT01408121|Other|Genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay|All patients will undergo genotyping and platelet reactivity testing with the VerifyNow P2Y12 assay, at least 6 hours after receiving a thienopyridine loading dose but before hospital discharge.
16198298|NCT01408108|Procedure|Laparoscopic hiatal repair with sub-lay partially absorbable lightweight mesh|"A fashioned according to the dimensions of hernia defect partially absorbable lightweight mesh Ultrapro™ (Ethicon, Inc.) will be sutured to both crura with 3 to 5 interrupted non-absorbable (Ethibond™ 3-0 by Ethicon, Inc.) sutures (as tension-free repair). Subsequent 2 to 3 interrupted non-absorbable sutures will approximate crura to completely cover a mesh to preclude its contact with the esophagus (original sandwich sub-lay technique)."
16198299|NCT01408108|Procedure|Laparoscopic primary posterior crural repair|"Posterior cruroraphy will be performed with 3 to 4 interrupted non-absorbable (Ethibond™ 3-0 by Ethicon, Inc.) sutures.
~In the both arms laparoscopic procedure will be done in a standard fashion: reduction of hernia with excision of hernia sac and mobilization of distal esophagus, exposure of borders of hiatal opening including crura posteriorly to esophagus, repair if hiatal hernia defect (30 Fr esophageal bougie is used), a short (2,5 - 3,5 cm) 360° fundoplication wrap (floppy-Nissen procedure) (30 Fr esophageal bougie is used)."
16198300|NCT01408095|Drug|LY2608204|Administered orally
16198301|NCT01408095|Drug|Glimepiride|Administered orally
16198302|NCT01408082|Drug|ISV-502 (1.0% azithromycin and 0.1% dexamethasone combined)|Azithromycin and Dexamethasone twice daily for 2 weeks
16198303|NCT01408082|Drug|Azasite|Azasite twice daily for 2 weeks
16198304|NCT01408082|Drug|Dexamethasone|Dexamethasone twice daily for 2 weeks
16198305|NCT01408082|Other|Vehicle|Vehicle twice daily for 2 weeks
16198306|NCT01408069|Drug|MIGRANE|1 to 2 tablets(ergotamine 1mg + caffeine 100mg + acetylsalicylic 350 mg + homatropine 1,2 mg)
16198307|NCT01408069|Drug|PARCEL|1 to 2 tablets(ergotamine 1mg + paracetamol 450 mg + caffeine 40 mg)
16198308|NCT01408056|Drug|Timolol 0.5% Gel Forming Solution (GFS)|"Dose-based escalation schedule for topical application:
~4-8 kg: Day 0-7: 1 drop every other day; Day 7-14: 1 drop daily; Day 14 - Day 60: 1 drop twice per day
~8-12 kg: Day 07: 1 drop daily; Day 7-14: 1 drop twice per day; Day 14 - Day 60: 2 drops twice per day"
16198309|NCT01408056|Drug|Mupirocin 2% Ointment|Topical application twice per day for 60 days
16198310|NCT01408043|Drug|plerixafor|Given SC
16198311|NCT01408043|Biological|filgrastim|Given SC
16198312|NCT01408043|Drug|etoposide|Given IV
16198313|NCT01408043|Procedure|leukapheresis|Undergo apheresis
16198314|NCT01408030|Drug|Sterile saline|0.9%, 0.1 ml spray in each nostril bid
16198315|NCT01408030|Drug|Bevacizumab|1% solution in saline, 0.1 ml spray in each nostril bid
16198316|NCT01408030|Drug|Estriol|0.1% suspension in methylcellulose, 0.1 ml spray in each nostril bid
16198317|NCT01408030|Drug|Tranexamic Acid|10% solution in saline, 0.1 ml spray in each nostril bid
16198318|NCT01408004|Drug|Pazopanib|Tablet 800mg qd til progression
16198319|NCT01408004|Drug|Everolimus|tablet 10 mg qd til progression
16198320|NCT01408004|Drug|Pazopanib|tablet 800mg qd, alternating schedule: 8 weeks Pazopanib, 8 weeks Everolimus
16198321|NCT01408004|Drug|Everolimus|tablet 10mg qd, alternating schedule: 8 weeks Pazopanib, 8 weeks Everolimus
16198322|NCT01408004|Drug|Everolimus|Everolimus 10mg qd monotherapy until second progression (PD per RECIST 1.1)when first progression after 8 weeks of Pazopanib in alternating regimen
16198373|NCT01407731|Genetic|western blotting|
16198374|NCT01407731|Other|laboratory biomarker analysis|
16198323|NCT01408004|Drug|Pazopanib|Pazopanib 800mg qd monotherapy until second progression (PD per RECIST 1.1) when first progression after 8 weeks of Everolimus in alternating regimen
16198324|NCT01407991|Other|enteral tube placement accuracy|The graph method is based on the infants' length determined by measurement using a length board and plotted on a graph derived from a formula to determine the depth for tube insertion (graph method). The graph method has been tested in the pediatric population but not in infants under six months of age (Klazner, Luke and Scalso, 2002). Using a graph method might reduce some of the variability in placement. We propose to extend the Klazner, Luke and Scalso (2002) study in the infant population.
16198325|NCT01407991|Other|NEM method for NG/OG tube placement|measure distance from the mouth to the ear and then the ear to mid abdomen and mark the tube to insert to that length
16198326|NCT01407978|Biological|Vaccination with Fluval P monovalent influenza vaccine|"Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant.
~Dose: 0.25 ml /total 3 μg HA/ in age group 3-12 years, and 0.5 ml /total 6 μg HA/ in age group 12-18 years, single dose."
16198327|NCT01407978|Biological|Vaccination with Fluval AB|"Vaccination with Fluval AB trivalent influenza vaccine with 15 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant.
~Dose: 0.25 ml /total 3x7.5 μg HA/ in age group 3-12 years, 0.5 ml /total 3x15 μg HA/ in age group 12-18 years, single dose."
16198328|NCT01407978|Biological|Vaccination with Fluval AB Novo|"Vaccination with Fluval AB Novo trivalent influenza vaccine with 6 μg HA/0.5ml/strain active ingredient content and aluminium phosphate gel adjuvant.
~Dose: 0.25 ml /total 3x3 μg HA/ in age group 3-12 years, 0.5 ml /total 3x6 μg HA/ in age group 12-18 years, single dose."
16198329|NCT01407965|Procedure|microdialysis catheter|Placing of microdialysis catheter in fatty tissue and in the peritoneal cavity
16198330|NCT01407965|Procedure|microdialysis catheter|Placing of microdialysis catheter in fatty tissue and in the peritoneal cavity
16198331|NCT01407952|Device|HydroCoil Embolic System|HydroCoil Embolic System
16198332|NCT01407952|Device|Control (bare platinum coils)|bare platinum coils
16198333|NCT01407926|Other|Nurse-Led Mental Health Promotion Intervention|The nurse-led intervention is a multi-faceted 6-month program led by a Registered Nurse that involves regular home visits, monthly case conferences, and evidence-based assessment and management of depression using an interprofessional approach.
16198334|NCT01407913|Procedure|caudal epidural steroid injection|injecting steroids in the epidural space via caudal route
16198335|NCT01407900|Drug|CD-NP|CD-NP as a four hour infusion at 10 ng/kg/min IV
16198336|NCT01407900|Drug|5% Dextrose in Water|four hour infusion IV
16198337|NCT01407887|Drug|artesunate (AS) - amodiaquine (AQ) - methylene blue (MB)|The group AS-AQ-MB will receive once daily a fixed dose AS-AQ formulation combined with once daily MB over a three days period.
16198338|NCT01407874|Drug|Placebo|Oral dose administered daily for 84 days.
16198339|NCT01407874|Drug|Ulodesine (BCX4208) 5 mg|Oral dose administered daily for 84 days.
16198340|NCT01407874|Drug|Ulodesine (BCX4208) 10 mg|Oral dose administered daily for 84 days.
16198341|NCT01407861|Other|Relaxation Training|Patients participate in a relaxation training program under expert guidance at least three times a week over 12 weeks.
16198342|NCT01407861|Other|Aerobic endurance Training|Patients participate in a moderate aerobic endurance training program under expert guidance three times a week over 12 weeks.
16198343|NCT01407848|Drug|Furosemide|Patients received nebulised Furosemide iv solution 1 mg/kg (4x/d) for max.3 consecutive days.
16198344|NCT01407848|Drug|Saline 0,9%|nebulised 0,9% saline 4x/d for max.3 days
16198345|NCT01407835|Biological|Four different concentrations of Dactylis glomerata allergen extract, positive control and negative control|Four concentrations of Dactylis glomerata allergen extract, together with a positive and negative control will be tested in every patient in duplicate on the volar surface of the forearm.
16198346|NCT01407822|Drug|Erlotinib|In the neo-adjuvant treatment phase, erlotinib 150 mg/day taken orally for 6 weeks(42 days).In the post-surgery phase, erlotinib 150mg/day taken orally for 1 year or till disease progression or unacceptable toxicity.
16198347|NCT01407822|Drug|Gemcitabine/cisplatin|In the neo-adjuvant treatment phase, patient will receive gemcitabine 1250mg/m2 IV on day 1 and day 8, and cisplatin 75mg/m2 on day 1 of a 3-week schedule for 2 cycles. In the post-surgery phase, Gemcitabine 1250mg/m2 IV on day 1 and day 8, and cisplatin 75mg/m2 on day 1 of a 3-week schedule for 2 cycles or till disease progression or unacceptable toxicity.
16198348|NCT01407809|Device|Venous Sinus Stenting|Venous sinus stenting consists of placing a stent into the narrowed veins of the brain.
16198349|NCT01407796|Drug|Endotoxin (E. coli O:113, Reference Endotoxin)|
16198350|NCT01407796|Drug|[18F](+/-)NOS|
16198351|NCT01407783|Behavioral|Problem Solving Tools (PST)|The problem solving tools was chosen as the depression treatment because it is well suited for use by non-mental health professionals and for in-home treatment. It is also a brief treatment (4-8 sessions) that takes a non-pathologizing approach.
16198352|NCT01407770|Genetic|DNA analysis|Genetic
16198353|NCT01407770|Genetic|gene expression analysis|Genetic
16198354|NCT01407770|Other|enzyme-linked immunosorbent assay|Genetic
16198355|NCT01407770|Other|flow cytometry|Genetic
16198356|NCT01407770|Other|laboratory biomarker analysis|Genetic
16198357|NCT01407770|Other|questionnaire administration|Genetic
16198358|NCT01407770|Procedure|adjuvant therapy|Genetic
16198359|NCT01407770|Procedure|assessment of therapy complications|Genetic
16198360|NCT01407770|Procedure|quality-of-life assessment|Genetic
16198361|NCT01407770|Radiation|3-dimensional conformal radiation therapy|Genetic
16198362|NCT01407770|Radiation|breast irradiation|Genetic
16198363|NCT01407770|Radiation|external beam radiation therapy|Genetic
16198364|NCT01407770|Radiation|hypofractionated radiation therapy|Genetic
16198365|NCT01407770|Radiation|intensity-modulated radiation therapy|Genetic
16198366|NCT01407770|Radiation|whole breast irradiation|Genetic
16198367|NCT01407757|Genetic|DNA analysis|
16198368|NCT01407757|Genetic|gene expression analysis|
16198369|NCT01407757|Other|laboratory biomarker analysis|
16198370|NCT01407757|Other|pharmacogenomic studies|
16198371|NCT01407744|Other|laboratory biomarker analysis|Correlative studies
16198375|NCT01407679|Drug|Alitretinoin|1 capsule Alitretinoin 30 mg per day; optional reduction to 10 mg per day in case unacceptable adverse reactions to the higher dose occur
16198376|NCT01407666|Procedure|paravertebral blocks|use bilateral thoracic paravertebral blocks for pain control
16198377|NCT01407653|Procedure|Virtual reality|3 sessions of immersion in a virtual reality 3D environment of 17 minutes per week for 4 consecutive weeks
16198378|NCT01407653|Procedure|Usual care|Classical care
16198379|NCT01407640|Procedure|Allergy tests|1/ to validate a diagnostic algorithm for patients presenting with possible allergy. 2/ to investigate immunogenetic profiles of patient with insulin allergy 3/ cellular mechanisms of IA
16198380|NCT01407627|Dietary Supplement|Fructose|"Subjects will be randomized to one of 2 sequences:
~Sequence 1: Fructose (intervention) 200g daily x 14d followed by Dextrose (control) 200g daily x 14d Sequence 2: Dextrose (control) 200g daily x 14d followed by Fructose (intervention) 200g daily x 14d"
16198381|NCT01407614|Procedure|external lumbar drainage (ELD) of cerebrospinal fluid|Patients were randomized for external lumbar drainage of cerebrospinal fluid or standard treatment of a subarachnoid hemorrhage alone. External drainage was started within 96 hours of initial subarachnoid hemorrhage during 7 days at a maximum of 5-10 ml/hour.
16198382|NCT01407601|Dietary Supplement|daily supplementation of MK-7 over 6 weeks|once daily intake of MK-7 prior to dialysis over 6 weeks
16198383|NCT01407588|Procedure|Magnetic navigation|Ablation with use of the magnetic navigation system
16198384|NCT01407588|Procedure|Ablation performed with manual navigation|Atrial fibrillation ablation performed with manual navigation
16198385|NCT01407575|Drug|Buprenorphine|low-dose buprenorphine (range 0.2 mg/day -- 1.6 mg/day)
16198386|NCT01407575|Drug|Placebo|matched placebo
16198387|NCT01407562|Drug|Pazopanib|Starting dose is 400 given on Days 2-5, 9-12, and 16-26 of each 28 day cycle
16198388|NCT01407562|Drug|Paclitaxel|Starting dose is 60 mg/m2 IV on days 1, 8, and 15 of each 28 day cycle
16198389|NCT01407562|Drug|Carboplatin|Starting dose of carboplatin that corresponds to an AUC of 2, IV on days 1, 8, and 15 of each 28 day cycle
16198390|NCT01407549|Behavioral|mindfulness group meetings with psychologist|The Mindfulness Program consists of one 2-hour session each week for 6 consecutive weeks plus a half day retreat near the end of the intervention. Participants will attend weekly group meetings (15-20 individuals per group) in which they will be guided through a progressive experiential exploration of mindfulness. Participants will be asked to develop a daily meditation practice of 30-45 minutes with audio-recordings for guidance, and will report the amount and type of practice in a daily dairy. . A psychologist with rich personal experience in mindfulness who is trained in mindfulness based therapy will be responsible for administering the program.
16198391|NCT01407536|Device|Thermal stimulation system|The subjects meeting our criteria will be randomly assigned to either the experimental group (EXP) or the control group (COT). The EXP and COT received upper extremity thermal stimulation protocol for 30 minutes a day for 20 days. The TS temperature of EXP for noxious stimulation was set at 46-47°C for heat and 7-8°C for cold stimulation; the temperature of COT for innoxious stimulation was set at 40°C for warm and 20°C for cold stimulation.
16198392|NCT01407523|Drug|Levetiracetam|"Formulation: concentrate for solution for infusion
~Strength: Levetiracetam injection (100 mg/mL) will be packed in 5 mL glass vials (500 mg/5 mL)
~Dosage: 1000 mg/day, 1500 mg/day, 2000 mg/day, 2500 mg/day or 3000 mg/day
~Frequency: twice daily"
16198393|NCT01407510|Drug|Mapracorat|Application of the investigational product on the affected skin areas
16198394|NCT01407497|Biological|DNA HIVIS and MVA-CMDR|600 µg i.d. (separate plasmids pools) of DNA priming at weeks 0, 4 and 12; 108 pfu i.m. MVA boosting at weeks 24 and 36
16198395|NCT01407497|Biological|DNA HIVIS and MVA-CMDR|1200 µg i.d. (separate plasmids pools) of DNA priming at weeks 0, 4 and 12 ; 108 pfu i.m. MVA boosting at weeks 24 and 36
16198396|NCT01407497|Biological|Saline solution|2 x 0.1 ml of saline solution i.d at weeks 0, 4 and 12 ; saline solution i.m at weeks 24 and 36
16198397|NCT01407497|Biological|Saline solution|2 x 0.2 ml of saline solution i.d at weeks 0, 4 and 12 ; saline solution i.m at weeks 24 and 36
16198398|NCT01407484|Drug|Prednisone|0,2 mg/kg/day for 3 weeks and 0,1mg/kg/day for 1 week.
16198399|NCT01407484|Drug|Placebo|Placebo 0,2 mg/kg/day for 3 weeks and 0,1mg/kg/day for 1 week
16198400|NCT01407471|Drug|Clobetasol + Spironolactone|One application 6 days a week during 4 weeks
16198401|NCT01407471|Drug|Clobetasol + Placebo|One application 6 days a week during 4 weeks
16198402|NCT01407471|Drug|Placebo + Spironolactone|One application 6 days a week during 7 weeks
16198403|NCT01407471|Drug|Placebo + Placebo|One application 6 days a week during 7 weeks
16198404|NCT01407458|Other|Upper Limb Exercises|Upper limb exercises
16198405|NCT01407458|Other|Normal physical exercises|Exercises usually done by children in physical education classes
16198406|NCT01407445|Drug|Placebo|1 tablet/ oral/ 3 times a day for 90 days
16198407|NCT01407445|Drug|Tribulus terrestris|1 tablet of 250mg/ oral/ 3 times a day for 90 days
16198408|NCT01407432|Drug|Folic acid|Taking of folic acid 15 mg per day by hanging oral route during 3 at 4 months
16198409|NCT01407432|Drug|placebo of folic acid|Taking of placebo of folic acid by hanging oral route during 3 at 4 months
16198410|NCT01407419|Other|Treatment Acceleration|"Subjects in the intervention group will be seen as frequently as monthly for subjects not achieving low disease activity (LDA) as defined as CDAI ≤10. Treatment acceleration will be expected to occur as frequently as monthly and at least every 3 months in these subjects, unless contraindicated.
~Treatment acceleration for the purposes of this trial include the following options: Change in prescribed treatment or dosage of traditional or biologic Disease Modifying Anti Rheumatic Drugs (DMARDs) or a change in the route of Methotrexate administration (from oral to subcutaneous)"
16198411|NCT01407419|Other|Monthly Assessment|Monthly disease assessments are expected to be scheduled until the subject has achieved a CDAI of 10 or less (low disease activity).
16198412|NCT01407406|Drug|BIIB023 - low dose IV Dose|
16198413|NCT01407406|Drug|BIIB023 - high dose IV Dose|
16198414|NCT01407393|Device|Glucosanol|2 tablets 3x daily for 12 weeks
16198415|NCT01407393|Device|Placebo|2 tablets 3x daily for 12 weeks
16198416|NCT01407380|Drug|PWT33597 mesylate|PWT33597 taken orally daily for 28 consecutive days in 28 day cycle
16199300|NCT01400490|Dietary Supplement|EPA-DHA Study|6 weeks of dietary supplementation
16198417|NCT01407354|Device|Lokomat treadmill training|Lokomat treadmill training: 12 wks, 3x/wk, 45 mins@session
16198418|NCT01407354|Other|Aquatic exercise therapy|Aquatic exercise training: 12 wks, 3x/wk, 45 mins@session
16198419|NCT01407341|Procedure|musculoskeletal complications management/prevention|Receive beta tricalcium-phosphate bone graft
16198420|NCT01407341|Procedure|bone graft|Receive beta tricalcium-phosphate bone graft
16198421|NCT01407341|Procedure|quality-of-life assessment|Ancillary studies
16198422|NCT01407341|Other|questionnaire administration|Ancillary studies
16198423|NCT01407315|Device|GlucoMenDay|"Subjects will receive a standardized lunch (100 g of CHO), administration of insulin will be performed by the subject based on insulin to carbohydrate ratio.
~An intravenous catheter will be inserted in one forearm and venous sampling will start 1 hour after lunch ingestion. Arterialized-venous blood sampling will be performed every 15 minutes for a period of two hours. Samples will be analyzed for glucose using the Super GL; concomitantly capillary measurements using the GlucoCard G Meter will be performed.
~This procedure can be performed on days 3-4 of monitoring; each subject randomized to Procedure A undergoes this procedure once."
16198424|NCT01407315|Device|GlucoMenDay|"Subjects will receive a standard breakfast (75g CHO), the usual morning insulin dose will be post-poned. An increased dose of rapid-acting insulin analogue aiming to produce minor hypoglycaemia based on insulin to carbohydrate ratio will be injected subcutaneously. Arterialized-venous sampling will be performed every 10 minutes for a period of two hours.
~Samples will be analyzed for glucose using the Super GL; concomitantly, capillary measurements using the GlucoCard G Meter will be performed.
~This procedure will be performed on days 2 and 4 of monitoring; each subject randomized to Procedure B undergoes this procedure twice."
16198425|NCT01407302|Other|Head rotation|Repeated ultrasonographic examination according to the degree of head rotation (examination of overlap index of internal jugular vein and common carotid artery, and accuracy of external landmark of jugular cannulation)
16198426|NCT01407289|Drug|Insulin Aspart, Insulin Glargine|The Intervention is a paper based protocol, which provides suggestions for new insulin doses (basal-bolus regime).
16198427|NCT01407276|Drug|Omarigliptin|Single oral dose of 3 mg (3 x 1-mg capsules)
16198428|NCT01407263|Procedure|Lymph node template|Inclusion of the external iliac, hypogastric and obturator fossa nodal groups in the template undergoing a Radical Prostatectomy. Modifying the template for lymph node dissection may lead to removal of additional affected nodes, reducing the chance of recurrence.
16198429|NCT01407263|Procedure|Transverse versus vertical closure|Transverse versus vertical closure of the port site incision
16198430|NCT01407263|Drug|antibiotic prophylaxis|One vs. three days of antibiotic prophylaxis at catheter removal
16198431|NCT01407237|Drug|Angiotensin II Infusion|Angiotensin II (Bachem) will be infused at 0.3 ng/kg/min for 30 minutes, then 1.0 ng/kg/min for 30 minutes, then 3.0 ng/kg/min for 30 minutes; at baseline and at each infusion concentration, serum aldosterone will be measured. BP and heart rate will be monitored at baseline and every 2 minutes during the infusion.
16198432|NCT01407224|Behavioral|Improve Early Breastfeeding|One arm got only training, another arm training and supervision and third arm without any intervention as control.
16198433|NCT01407211|Dietary Supplement|vitamin A|"25000 IU/day vitamin A 6 months
~1 Cap/Day
~1 cap placebo/day for 6 month"
16198436|NCT01407185|Other|Resistive Exercise Training|Resistive Exercises (between 8 and 12 exercises for both upper and lower body) at 30 to 60% of 1 RM for 2x per week for 12 months.
16198437|NCT01407133|Device|transcranial magnetic stimulator (class 2b) Medtronic © MagPro X100 (with MagOption) stimulator and Butterfly Coil MCF-B65 (figure-8 coil with fluid cooling)|"The study is based on a dual procedure consisting of comparisons between active and sham rTMS on the one hand and between four increasing levels of magnetic pseudo-dose on the other hand. Each level comprises 16 patients randomly assigned to active rTMS group (12 patients) or sham rTMS group (4 patients). The transition from one level to another is authorized by an independent oversight committee charged with checking the tolerability of rTMS sessions for the tested level. The neuronavigated rTMS use either active or sham figure-eight coil and is centered over the primary auditory cortex contralateral to the perceived predominant side of tinnitus. This target is located through anatomical brain MRI and neuronavigated brain system. According to the stimulation parameters, each rTMS session can last from 5 to 112 minutes and the whole rTMS intervention from 1 to 20 weeks. The follow-up is spread over twelve months."
16198438|NCT01407133|Device|Sham transcranial magnetic stimulator Medtronic © MagPro X100 (shielded figure-8 coil with fluid cooling)|Same sound level as active rTMS, but magnetic field strongly attenuated
16198439|NCT01407120|Behavioral|New Beginnings Program|A preventive intervention for divorced families.
16198440|NCT01407107|Drug|Nitroglycerin 0.2 MG/HR|0.2mg/hr nitroglycerin transdermal patch daily. The first 3 patients will have a low dose patch applied (0.2 mg/hr).
16198441|NCT01407107|Drug|Nitroglycerin 0.4 MG/HR|0.4mg/hr nitroglycerin transdermal patch daily. The first 3 patients will have a low dose patch applied (0.2 mg/hr) if this is well tolerated a higher dose patch (0.4mg/hr) will be used for the next 3 patients.
16198442|NCT01407107|Drug|Nitroglycerin 0.6 MG/HR|0.6mg/hr nitroglycerin transdermal patch daily. The first 3 patients will have a low dose patch applied (0.2 mg/hr) if this is well tolerated a higher dose patch (0.4mg/hr) will be used for the next 3 patients and if this is well tolerated an even higher dose patch (0.6mg/hr) will be used.
16198443|NCT01407094|Drug|Sertraline|50-200mg/day
16198444|NCT01407094|Drug|Placebo|1-4 pills per day
16198445|NCT01407094|Drug|BupropionXL|150-450 mg/day
16198446|NCT01407081|Behavioral|Telerehabilitation Cognitive Strategy Training|The strategy intervention is a 16-week program during which a trained rehabilitation coach speaks by telephone to the stroke participant and their caregiver twice a week (one approximately 45-minute 'training' call and one approximately 15-minute 'update' call). Rehabilitation discussions during the training calls will follow a detailed protocol and focus each week on the stroke education and cognitive strategy training information provided in each section of the manual provided to the participants.
16198447|NCT01407068|Biological|AA4500 collagenase clostridium histolyticum|2 concurrent injections (0.58 mg) into 2 cords on the same hand
16198448|NCT01407055|Behavioral|Expectation Manipulation Intervention|The Expectation Manipulation Intervention targets patients' expectations prior to surgery (2 individual sessions, 2 phone calls). Main goal is to enhance positive outcome expectancies, as well as to improve patients' control expectations about possible side effects of the surgery and about their personal management of their coronary heart disease. Further EMI tries to correct dysfunctional beliefs about the coronary heart disease and tries to minimize fears about expected negative consequences.
16198449|NCT01407055|Behavioral|Supportive Therapy|Supportive therapy employs common factors such as elicitation of affect, reflective listening, feeling understood, but provides no explicit theoretical formulation to the patient. Supportive therapy thus provides a control condition for common factors and therapist attention but lacks the specific intervention part. It will be delivered in the same frequency and at the same time points as the Expectation Manipulation Intervention (2 individual sessions, 2 phone calls).
16198450|NCT01407042|Procedure|mobile-bearing unicondylar knee arthroplasty|mobile-bearing unicondylar knee arthroplasty
16198451|NCT01407016|Drug|metronidazole IV 500 mg|On Day 1, subjects will receive a single dose of 500 mg metronidazole by intravenous infusion over 20 minutes. On Day 3 to Day 7, subjects will receive multiple doses of 500 mg metronidazole by intravenous infusion over 20 minutes 4 times a day (every 6 hours) for 5 days.
16198452|NCT01407003|Drug|LIK066|Participants will receive a single or multiple doses of LIK066
16198453|NCT01407003|Drug|Placebo|Participants will receive a single or multiple doses of a matching placebo
16198454|NCT01406977|Drug|BPS804|
16198455|NCT01406964|Other|CAT test|A CAT test is performed in order to diagnose tubal factor causes
16198456|NCT01406964|Other|Histerosalpingography|A Histerosalpingography is performed.
16198457|NCT01406938|Drug|AIN457 150mg|(1 injection per dose) and placebo to secukinumab 150 mg
16198458|NCT01406938|Drug|AIN457 300mg|secukinumab 150 mg (2 injections per dose)
16198459|NCT01406925|Drug|Placebo control|Placebo cream
16198460|NCT01406925|Drug|NRL001 cream|Cream for single-dose intra-anal application
16198461|NCT01406912|Other|Recreational Activity|Recreational activities (playing cards, arts and crafts, dominoes, jenga or a ball game) and conventional rehabilitation.
16198462|NCT01406912|Other|Wii Gaming System Arm|Virtual reality Wii games (tennis and bowling from Wii® Sports, and bean bag, bocce ball, ping cup, darts or shuffleboard from Wii® Game Party 3) and conventional rehabilitation.
16198463|NCT01406899|Behavioral|Computer Based Treatment|Standard treatment as usual (TAU) plus coping skills computer program. In addition to the individual and group therapy sessions (TAU), individuals will work with a computerized program that teaches skills for stopping substance use and increasing coping skills twice weekly for 8 weeks.
16198464|NCT01406886|Behavioral|Eating rate|
16198465|NCT01406873|Drug|Mexiletine|150 mg/kg Mexiletine capsules taken by mouth, three times daily for 6 months
16198466|NCT01406873|Drug|Placebo|150 mg/kg placebo capsules taken by mouth, three times daily for 6 months
16198467|NCT01406860|Drug|Droperidol|Droperidol 1.25 mg IV x 1, may repeat 0.625 mg if needed at 60 minutes
16198468|NCT01406860|Drug|Metoclopramide + diphenhydramine|Metoclopramide 20 mg IV infusion q30 minutes as needed with a maximum of 4 doses + Diphenhydramine 25 mg IV injection x 1 given with the first dose of metoclopramide IV infusion and repeated x 1 given with the third metoclopramide IV infusion.
16198469|NCT01406847|Other|Spinal Manipulation|High velocity low amplitude joint-biased intervention
16198470|NCT01406847|Other|Spinal Mobilization|Low velocity, large amplitude oscillating joint biased technique
16198471|NCT01406847|Other|Static Touch|The investigators maintains hand contact with both hands over the lumbar area of the participant
16198472|NCT01406834|Behavioral|Impact of Killing CBT Treatment|Treatment will include six, one hours sessions with a licensed clinical psychologist or an advanced postdoctoral fellow under the close supervision of a licensed psychologist.
16198473|NCT01406821|Procedure|Ultrasound-guided platelet-rich-plasma (PRP) injection|Blood will be drawn, and platelet-rich plasma will be injected into the tendon under ultrasound guidance.
16198474|NCT01406821|Procedure|Ultrasound-guided dry needling|Blood will be drawn, and tendon will be penetrated with dry needle under ultrasound guidance. Nothing will be injected into the tendon.
16198475|NCT01406808|Behavioral|genetic risk score for coronary risk factors|genetic risk score based on coronary artery disease genetic risk variants (SNPs)
16198476|NCT01406795|Device|Gore Viabahn Heparin Coated Stent|For subjects deemed to be suffering from chronic venous insufficiency of the femoral or popliteal veins, a Gore Viabahn stent will be implanted during a venoplasty procedure to determine whether the vein will stay open.
16198477|NCT01406782|Biological|rituximab|
16198478|NCT01406782|Genetic|DNA analysis|
16198479|NCT01406782|Genetic|gene expression analysis|
16198480|NCT01406782|Genetic|polymerase chain reaction|
16198481|NCT01406782|Other|laboratory biomarker analysis|
16198482|NCT01406769|Procedure|Bioelectric Impedance Analysis|Undergo preoperative and postoperative lower-extremity lymphedema assessment
16198483|NCT01406769|Procedure|Lymphadenectomy|Undergo lymphadenectomy
16198484|NCT01406769|Procedure|Therapeutic Conventional Surgery|Undergo radical vulvectomy or radical local excision
16198485|NCT01406743|Device|EOS™ Acquisition|Double Incidence Postero Anterior and Lateral full body low-dose X-ray acquisition on EOS™ device following SOP of the service of radiology.
16198486|NCT01406730|Other|exercise|16 week of periodized progressive running exercise 2-4 times/week
16198487|NCT01406717|Drug|SPIL1033|5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
16198488|NCT01406717|Drug|Placebo|5 mcg twice daily for the first 4 weeks and 10 mcg twice daily for the remaining 20 weeks. To be self-administered twice daily.
16198489|NCT01406704|Drug|Rosiglitazone|Rosiglitazone (8 mg/day)
16198490|NCT01406704|Drug|alpha-lipoic acid|alpha-lipoic acid (1800 mg/day)
16198491|NCT01406704|Drug|Rosiglitazone/alpha-lipoic acid|combination of Rosiglitazone (8 mg/day) and Thioctic acid (1800 mg/day)
16198492|NCT01406691|Device|Flashes|three hours of a sequence of light flashes (4000 lux, 3 msec, every 30 seconds); occurs during three hours immediately prior to desired waketime
16200478|NCT01390935|Other|guideline adherence|guideline adherence of physician
16198493|NCT01406678|Procedure|RIPC|3 cycles of 5 min left upper arm ischemia by inflation of a blood pressure cuff to 200 mmHg and 5 min reperfusion
16198494|NCT01406678|Procedure|Control|Coronary artery bypass surgery without remote ischemic preconditioning protocol
16198495|NCT01406678|Drug|isoflurane+sufentanil anesthesia|Anaesthesia is maintained by inhaled isoflurane in concentrations 0.7-0.8 % end-tidal with additional sufentanil injected during surgery, as required. During extracorporal circulation patients receive isoflurane via a vaporizer incorporated in the extracorporeal gas supply in the same concentrations.
16198496|NCT01406652|Procedure|Two-stage bursectomy|Debridement, drainage, and secondary closure of septic bursitis during two surgical interventions
16198497|NCT01406639|Drug|Ranibizumab|Patients will be treated with a total of 4 applications of ranibizumab in a fine mist spray. This will be done with 2 mgs in 0.2cc; 0.1cc sprayed into each nostril a day; therefore 8 mgs will require 4 days of application. If, following the first treatments, they experience recurrent bleeding (equal to or less than a 75% reduction in their ESS number as compared to pre treatment), they will be offered the opportunity to be prescribed a second administration, to be completed in the same way (4 applications of 4 mg in 0.4 cc with 0.2cc per nostril).
16198498|NCT01406626|Behavioral|Peer Navigator|Peer navigation intervention to improve linkage to and retention in HIV care and suppress viral load for underserved HIV+ persons in Los Angeles
16198499|NCT01406613|Other|Observation|In this study we will examine the changes in bone density by DXA and QUS and bone turnover after stopping Bisphosphonate treatment. As we wish to measure the speed of offset of effects of treatment we have scheduled visits at 24 week intervals in order to fully assess this effect.
16198500|NCT01406600|Drug|recombinant hCG (Ovidrel®)|Recombinant hCG (Ovidrel®)will be administrated for final oocyte maturation triggering in poor responders with different two doses (250mcg vs. 500mcg). Usually rhCG is administrated after 24~48 hours from optimal ovarian stimulation status.
16198501|NCT01406587|Drug|PP4001|50 mg, 1 dose every 12 hours x 4 doses
16198502|NCT01406587|Drug|PP4001|100 mg, 1 dose every 12 hours x 4 doses
16198503|NCT01406587|Drug|PP4001|200 mg, 1 dose every 12 hours x 4 doses
16198504|NCT01406587|Drug|Placebo|Placebo, 1 dose every 12 hours x 4 doses
16198505|NCT01406574|Drug|OPB-31121|Oral administration, 400 mg/day or 600 mg once daily after breakfast during the treatment period (1 month)
16198506|NCT01406574|Drug|OPB-31121 phase2|Oral administration, recommended dose from Phase1 once daily after breakfast during the treatment period (6 months)
16198507|NCT01406561|Drug|OMS103HP-S|Proprietary concentration and formulation of OMS103HP in solution (OMS103HP-S) for injection into each 3 liter vehicle irrigation solution bag for use during meniscectomy surgery
16198508|NCT01406561|Drug|Vehicle|3 Liter bags of vehicle irrigation solution for use during meniscectomy surgery
16198509|NCT01406548|Drug|BPS804|
16198510|NCT01406548|Drug|Placebo|
16198511|NCT01406548|Drug|BPS804|
16198512|NCT01406548|Drug|Placebo|
16198513|NCT01406548|Drug|BPS804|
16198514|NCT01406548|Drug|Placebo|
16198515|NCT01406535|Drug|Vardenafil|5 mg vardenafil per os twice daily
16198516|NCT01406535|Other|Placebo|5 mg placebo per os twice daily
16198517|NCT01406522|Drug|Oral tacrine|Tacrine, 160 mg per day, four times daily
16198518|NCT01406522|Drug|Oral placebo|Microcrystalline cellulose
16198519|NCT01406509|Biological|0.5ml/dose for a person|group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine of 0.5ml/dose for a person, on day0
16198520|NCT01406509|Biological|0.5ml/dose for a person|group A, C polysaccharide meningococcal and type b haemophilus Influenzal Conjugate vaccine of 0.5ml/dose for a person, on day0, 28
16198521|NCT01406496|Drug|insulin|Three different timings of insulin delivered by a pump
16198522|NCT01406483|Other|Platelet reactivity assessment|Platelet reactivity, as measured by the Chrono-log Lumi-Aggregometer, VerifyNow P2Y12 assay, and Vasodilator Stimulated Phosphoprotein (VASP) flow cytometry assay.
16198523|NCT01406470|Drug|Immune Globulin Intravenous (Human) 5% Liquid, IVIG-SN™|IVIG-SN™ 10g/200mL, dose is 300-900 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with IVIG-SN™ will be 12 months with a 3 month follow-up.
16198524|NCT01406444|Drug|rhIGF-1|Study participants will be started at a dose of 30 mcg/kg BID and will be titrated.
16198525|NCT01406444|Drug|Risedronate|Risedronate 35mg PO one time weekly
16198526|NCT01406444|Drug|Placebo|Placebo injections 30 mcg/kg BID, Placebo tablet PO once weekly
16198527|NCT01406431|Drug|Pitavastatin, Valsartan|Pitavastatin 4mg(2 tablets), Valsartan 160mg(1 tablet)
16198528|NCT01406431|Drug|Livalo® fixed combination drug|Livalo® fixed combination drug(1 tablet)
16198529|NCT01406418|Biological|CR6261 2 mg/kg|Administered as a single 2-hour intravenous infusion
16198530|NCT01406418|Biological|CR6261 5 mg/kg|Administered as a single 2-hour intravenous infusion
16198531|NCT01406418|Biological|CR6261 15 mg/kg|Administered as a single 2-hour intravenous infusion
16198532|NCT01406418|Biological|CR6261 30 mg/kg|Administered as a single 2-hour intravenous infusion
16198533|NCT01406418|Biological|CR6261 50 mg/kg|Administered as a single 2-hour intravenous infusion
16198534|NCT01406418|Biological|Placebo|Administered as a single 2-hour intravenous infusion
16198535|NCT01406405|Procedure|Posterior/Transforaminal Lumbar Interbody Fusion (P/TLIF), Anterior Cervical Discectomy and Fusion (ACDF)|Lumbar or cervical fusion
16198536|NCT01406392|Drug|Misoprostol 25mcg|Vaginal misoprostol or placebo tablets will be administered for each six hours until the maximum dose of 200mcg or eight tablets.
16198537|NCT01406392|Drug|Sublingual Misoprostol|Sublingual misoprostol or placebo tablets will be administered for each six hours until the maximum dose of 100mcg or eight tablets
16198538|NCT01406379|Procedure|Prophylactic clip|Before conventional snare polypectomy, hemoclips were applied on the base of stalk in the prophylactic clip group
16198539|NCT01406379|Procedure|Detachable snare|In the detachable snare group, detachable snare was positioned at the base of stalk and followed by conventional snare polypectomy
16198633|NCT01405716|Behavioral|Mindfulness Meditation|8-week mindfulness based program will be compared to and education control group
16198634|NCT01405716|Behavioral|Health Education|8-week health education program
16198635|NCT01405703|Other|xrays|xrays from 2 week postop to 5 year postop
16198540|NCT01406366|Behavioral|Group 1: Bright Futures Oral Health Curriculum|Residents who are randomized to Group 1 will receive a resident curriculum that exposes them to Bright Futures concepts of health promotion, including partnership building, communication and oral health. Group 1 residents will complete 7 modules, 3 on Bright Futures concepts (health, partnership building and communication), and 4 on oral health promotion. These modules have been developed in collaboration with the Pediatrics in Practice workgroup and the Open Wide modules endorsed by the American Academy of Pediatrics and the Maternal and Child Health Bureau. The oral health modules address dental caries development and prevention, importance of identifying maternal oral health status, duration of bottle-feeding or breastfeeding and discouraging both during sleep.
16198541|NCT01406366|Behavioral|Group 2: Iron Deficiency Training Module|Our study team opted to include a single 1-hour educational module addressing the identification and prevention of iron deficiency created by the AAP on Pedialink® to the active control group. This educational module addresses screening for and assessing risk for iron deficiency.
16198542|NCT01406353|Procedure|Percutaneous Mitral Commissurotomy|Percutaneous mitral commissurotomy is performed by experienced interventional cardiologists using the Inoue balloon technique. During the procedure, conventional hemodynamic parameters are monitored. A successful immediate result is defined as a mitral valve area > 1.5 square cm with less than moderate to severe mitral regurgitation.
16198543|NCT01406340|Drug|5 mg GSK1278863|5 mg per day administered orally for 14 days for normal subjects and subjects with Stage 3/4 renal function; 5 mg per day administered orally for 15 days for subjects with Stage 5 renal function
16198544|NCT01406327|Drug|Ambrisentan|Ambrisentan
16198545|NCT01406314|Drug|GSK2315698|Intravenous infusion for approximately 48hours followed by subcutaneous injection
16198546|NCT01406301|Drug|fondaparinux|fondaparinux
16198547|NCT01406288|Other|HUS standard coverage care (including in ICU)|HUS standard coverage care : plasmaphereses - eculizumab - Immunoadsorption
16198548|NCT01406275|Drug|Amoxicillin and clavulanate|
16198549|NCT01406262|Biological|Albiglutide|once weekly subcutaneous injection
16198550|NCT01406262|Drug|Moxifloxacin|oral tablet
16198551|NCT01406249|Drug|SP|"Drug: S-1:
~S-1 will be administered at 40 mg/m2 orally, twice daily (80 mg/m2 total daily dose) on Days 1 through 21 of each 35-day treatment cycle.
~Drug: Cisplatin:
~Cisplatin will be administered at 60 mg/m2 by intravenous infusion on Day 8 of each 35-day treatment cycle."
16198552|NCT01406249|Drug|XP|"Drug: Capecitabine:
~Capecitabine will be administered at 1,000 mg/m2 orally, twice daily (2,000 mg/m2 total daily dose) on Days 1 through 14 of each 21-day treatment cycle.
~Drug: Cisplatin:
~Cisplatin will be administered at 80 mg/m2 by intravenous infusion on Day 1 of each 21-day treatment cycle."
16198553|NCT01406236|Procedure|Transradial PCI|Transradial PCI
16198554|NCT01406236|Procedure|Transfemoral PCI|Transfemoral PCI
16198555|NCT01406223|Drug|Varenicline|
16198556|NCT01406223|Drug|Bupropion|
16198557|NCT01406223|Drug|Nicotine patches|
16198558|NCT01406223|Other|Placebo varenicline|
16198559|NCT01406223|Other|Placebo bupropion|
16198560|NCT01406223|Other|Placebo patch|
16198561|NCT01406197|Drug|Experimental: Vaginal progesterone|Vaginal progesterone formulation (150 mg micronized progesterone daily)
16198562|NCT01406197|Drug|Experimental: Topical progesterone|Progesterone will be applied daily (150 mg micronized progesterone)by topical application
16198563|NCT01406197|Drug|Experimental: Intramuscular progesterone|Preterm labor patients will be injected IM with micronized progesterone (50 mg/day).
16198564|NCT01406184|Other|Durham Connects|The program consists of 4-7 intervention contacts, including 1) a hospital birthing visit when a staff member schedules an initial home visit; 2) 1-3 nurse home visits between 3-12 weeks of infant age to provide physical assessments for infant and mother, intervention and education, assessment of family-specific needs, and connections to matched community resources, as needed, to provide longer-term support; 3) 1-2 nurse contacts with community service providers to facilitate successful connections; and 4) a telephone follow-up one month after case closure to review community connection outcomes. With family consent, letters from the program reporting on the visit are also provided to also connect families to maternal and infant healthcare providers for ongoing support.
16198565|NCT01406171|Drug|Isavuconazole|oral
16198566|NCT01406171|Drug|Midazolam|Oral
16198567|NCT01406158|Drug|Solifenacin Succinate Formulation A|oral suspension
16198568|NCT01406158|Drug|Solifenacin Succinate Formulation B|oral suspension
16198569|NCT01406158|Drug|Solifenacin Succinate|oral tablet
16198570|NCT01406145|Drug|ASP0777|oral tablet
16198571|NCT01406145|Drug|Placebo|oral tablet
16198572|NCT01406132|Drug|ASP015K|oral
16198573|NCT01406119|Drug|ABT-806|ABT-806 will be administered by intravenous infusion.
16198574|NCT01406106|Dietary Supplement|Plant stanol esters|The administration of a dairy product in the form of liquid yoghurt, marketed in Spain, that contains 2 g per container of plant stanol esters: sitostanol and campestanol (AHA recommended dose - 1.5 to 3 g). The enriched product and the placebo will have the same characteristics (composition and outward appearance), but the placebo will not contain stanol esters. The dose will be one container a day, after the main meal, for 24 months. The participants may continue with their previously prescribed lipid-lowering treatment and new treatment needed for this disease or for other diseases. Composition per container: proteins 1.8 g, carbohydrates 9.8 g, fat (except stanol) 1.4 g, plant stanol 2 g, vitamin B6 0.6 mg, folic acid 60 mg. The control group will receive one unit a day of yoghurt not supplemented with stanol esters that has a similar appearance to the enriched yoghurt.
16198575|NCT01406080|Drug|Adapalene|Apply approximately 1 gram of Differin 0.3% every night on the entire face, except near the eye region.
16198576|NCT01406080|Drug|Tretinoin|Apply approximately 1 gram of Tretinoin emollient cream 0.05% every night on the entire face, except near the eye region.
16198577|NCT01406067|Behavioral|Treatment Program for Children with Aggressive Behavior|24 sessions with the child aiming at the reduction of peer related aggressive behavior via social skills training. Additionally up to 10 sessions with relatives of the child in most cases with the parents.
16198636|NCT01405677|Biological|Epaxal 0.25 mL|12 IU hepatitis A antigen coupled to immunopotentiating reconstituted Influenza virosome (IRIV)
16198637|NCT01405677|Biological|Epaxal 0.5 mL|24 IU hepatitis A antigen coupled to IRIV
16198578|NCT01406067|Behavioral|Play group|12 double sessions (totally 24 treatment hours) in groups with up to 5 children. Different play activities were presented including techniques to activate resources of the child. These interventions give the children the opportunity to train pro-social interactions. Additionally up to 3 parent sessions were also included.
16198579|NCT01406054|Other|neuromuscular exercises|neuromuscular exercises delivered as a pre-practice and pre-game warm-up including dynamic stretching, strengthening, and plyometrics.
16198580|NCT01406041|Biological|Chemical and physical detection|CVP, Urine volume per day, Blood electrolytes, Urine sodium per day, Pituitrin
16198581|NCT01406028|Behavioral|Phone calls|Phone calls to offer emotional support
16198582|NCT01406015|Drug|Spironolactone|50 mg once daily for 6 weeks.
16198583|NCT01406015|Drug|Placebo|Placebo-matching spironolactone once daily for 6 weeks.
16198584|NCT01406002|Drug|darexaban|oral
16198585|NCT01406002|Drug|Rifampicin|oral
16198586|NCT01405989|Drug|darexaban|oral
16198587|NCT01405989|Drug|ketoconazole|oral
16198588|NCT01405976|Device|life style modification, noninvasive ventilation, CPAP|life style modification, noninvasive ventilation, CPAP
16198589|NCT01405963|Drug|AMG 157 Matching Placebo|Matching placebo administered as multiple IV doses in subjects with mild atopic asthma
16198590|NCT01405963|Drug|AMG 157|One dose level of AMG 157 administered as multiple IV doses in subjects with mild atopic asthma.
16198591|NCT01405950|Drug|Zanaflex Capsules|0.025 mg/kg
16198592|NCT01405950|Drug|Zanaflex Capsules|0.05 mg/kg
16198593|NCT01405950|Drug|Zanaflex Capsules|0.075 mg/kg
16198594|NCT01405950|Drug|Zanaflex Capsules|0.1 mg/kg
16198595|NCT01405937|Drug|vaniprevir|vaniprevir capsules containing 150 mg vaniprevir, orally, two in the morning and two in the evening for 12 or 24 weeks
16198596|NCT01405937|Biological|peg-IFN|peg-IFN 1.5 µg/kg once per week, subcutaneously (SC) for 24 weeks
16198597|NCT01405937|Drug|ribavirin|Capsules containing 200 mg ribavirin, orally, 3 to 5 capsules, dosage based on participant weight (600 mg/day to 1000 mg/day), for 24 weeks
16198598|NCT01405924|Drug|Fosaprepitant dimeglumine|Fosaprepitant 150 mg, IV on Day 1 of chemotherapy in Cycle 2
16198599|NCT01405924|Drug|5-HT3 RA|5-HT3 RA will be administered at the same dosage in Cycle 2 of chemotherapy as was used for each particpant in Cycle 1 of chemotherapy.
16198600|NCT01405924|Drug|Dexamethasone|Dexamethasone will be administered at the same dosage in Cycle 2 of chemotherapy as was used for each particpant in Cycle 1 of chemotherapy.
16198601|NCT01405924|Drug|Rescue medication|Rescue medication is defined as any medication used to relieve the symptoms of established nausea or vomiting. Multiple medications are permitted by the protocol and may be taken by the participant, including 5-HT3 antagonists, phenothiazines and benzodiazepines.
16198602|NCT01405911|Drug|Placebo for Sitagliptin 25 mg|1 tablet orally once daily before breakfast for 8 weeks
16198603|NCT01405911|Drug|Placebo for Sitagliptin 50 mg|1 tablet orally once daily before breakfast for 8 weeks
16198604|NCT01405911|Drug|Sitagliptin 25 mg|1 tablet orally once daily before breakfast for 8 weeks
16198605|NCT01405911|Drug|Sitagliptin 50 mg|1 tablet orally once daily before breakfast for 8 weeks
16198606|NCT01405898|Dietary Supplement|beetroot juice|Beetroot juice 4 weeks 250ml daily
16198607|NCT01405898|Dietary Supplement|Nitrate-free beetroot juice|Nitrate-free beetroot juice 4 weeks 250ml daily
16198608|NCT01405885|Biological|INO-3605|0.9mg of INO-3605 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.
16198609|NCT01405885|Biological|INO-3609|0.9mg of INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.
16198610|NCT01405885|Biological|INO-3401|0.9mg of 3401 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.
16198611|NCT01405885|Biological|INO-3609|0.3mg of INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.
16198612|NCT01405885|Biological|INO-3605 AND INO-3609|0.45mg each of INO-3605 AND INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.
16198613|NCT01405885|Biological|INO-3510|0.3mg each of INO-3605, INO-3609 AND INO-3401 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.
16198614|NCT01405885|Biological|INO-3609|0.9mg of INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 16 and 24.
16198615|NCT01405885|Biological|INO-3609|0.9mg of INO-3609 vaccine delivered ID followed by electroporation on Day 0 and Week 8
16198616|NCT01405885|Biological|Seasonal Influenza vaccine|0.5ml of vaccine delivered IM
16198617|NCT01405885|Biological|INO-3609|1.8mg of INO-3609 vaccine delivered ID followed by electroporation on Day 0, Week 8 and 24.
16198618|NCT01405872|Other|AVONEX PEN|Participants receive Avonex PEN commercially prescribed according to the local prescribing information.
16198619|NCT01405846|Drug|Gefitinib|250mg od for 6 months
16198620|NCT01405833|Drug|BG00010 (Neublastin)|Multiple doses, weight-based IV administration
16198621|NCT01405833|Drug|Placebo|Single dose IV matched placebo
16198622|NCT01405820|Drug|natalizumab IV|natalizumab for IV Infusion
16198623|NCT01405820|Drug|natalizumab SC|natalizumab for Subcutaneous Injection
16198624|NCT01405820|Drug|IV Placebo|Intravenous placebo to natalizumab
16198625|NCT01405820|Drug|SC Placebo|Subcutaneous placebo to natalizumab
16198626|NCT01405807|Drug|Alemtuzumab|Alemtuzumab will be administered on Day 1 and Day 2 at 0 and 6 months
16198627|NCT01405794|Drug|32ppm Silver Particle|Oral silver dose of 32ppm
16198628|NCT01405794|Drug|Placebo|Sterile Water No Silver
16198629|NCT01405768|Drug|sodium bicarbonate buffered lidocaine|8.4% sodium bicarbonate will be mixed with lidocaine in a 1:10 ratio prior to mixing with epinephrine and injecting into the cervix.
16198630|NCT01405768|Drug|Non-buffered lidocaine|
16198631|NCT01405755|Behavioral|Appropriate complementary feeding messages|Messages delivered through National Vaccine Program and radio
16198632|NCT01405742|Drug|rF.VIII|40 IU/kg recombinant factor VIII will be given once-weekly or thrice-weekly by intravenous injection for 26 weeks. At 26 weeks after a 72 hour washout period, 40 IU/kg recombinant factor VIII will be given thrice-weekly or once-weekly, respectively, by intravenous injection until week 52, with up to two rescue doses per week for bleeds
16200479|NCT01390922|Drug|Botulinum Toxin Type A|Botulinum Toxin Type A
16198638|NCT01405677|Biological|Havrix Junior 0.5 mL|720 EU hepatitis A antigen absorbed onto aluminum hydroxide
16198639|NCT01405664|Other|Weight-Bearing as Tolerated|WBAT immediately after surgery
16198640|NCT01405651|Drug|ONO-6950|30 mg, 100 mg, 300 mg at multiple doses
16198641|NCT01405651|Drug|ONO-6950|Placebo to match ONO-6950 tablets dosed in a similar manner to ONO-6950
16198642|NCT01405638|Behavioral|Motivational Interviewing|One-on-one client-centered counseling for lifestyle changes related to blood pressure control
16198643|NCT01405638|Behavioral|Patient Navigation|One-on-one navigation to guide participants through the process of being screened for colorectal cancer.
16198644|NCT01405625|Other|Pictogram-based asthma action plan|Asthma action plan using plain language, pictograms, and photographs
16198645|NCT01405625|Other|AAAAI standard of care written action plan|
16198646|NCT01405612|Drug|Midazolam|Single oral administration on Day 1 or Day 5
16198647|NCT01405612|Drug|Ulimorelin|Intravenous infusion of 480 micrograms/kg on Days 1 to 5
16198648|NCT01405599|Drug|Ulimorelin|Single dose of 480 micrograms/kg administered as a 30 minute intravenous infusion
16198649|NCT01405586|Drug|Gemcitabine|1000mg/m2 days 1 and 8 every 3 weeks for 6 cycles
16198650|NCT01405586|Drug|Gemcitabine|1200 mg/m2 days 1 and 8 every 3 weeks for 6 cycles
16198651|NCT01405586|Drug|Cisplatin|60 mg/m2 day 1 every 3 weeks for 6 cycles
16198652|NCT01405573|Other|Best Supportive Care|Therapy given according to clinical practices at participating centres. Experimental therapies not permitted.
16198653|NCT01405573|Drug|sorafenib|400 mg twice a day
16198654|NCT01405560|Drug|Vaniprevir|Capsules containing 150 mg vaniprevir, orally, two in the morning and two in the evening for 24 weeks
16198655|NCT01405560|Biological|peg-IFN|Open-label peg-IFN alfa-2b at 1.5 μg/kg once per week, administered subcutaneously (SC) for 24 weeks
16198656|NCT01405560|Drug|ribavirin|Capsules containing 200 mg RBV, orally, 3 to 5 capsules, dosage based on the participant's weight (600 mg/day to 1000 mg/day), for 24 weeks
16198657|NCT01405521|Biological|Vaccine placebo (excipients only)|single oral dose,
16198658|NCT01405521|Biological|Ty21a|3 oral doses, alternate days
16198659|NCT01405521|Biological|M10ZH09 vaccine|single oral dose
16198660|NCT01405508|Drug|Brivaracetam tablets|100 mg, intake twice daily (BID) for 7 days during Run-In Period
16198661|NCT01405508|Drug|Brivaracetam bolus|10 mL (= 100 mg) of Brivaracetam administered intravenously over 2 minutes twice daily (BID) during Evaluation Period
16198662|NCT01405508|Drug|Brivaracetam infusion|10 mL (= 100 mg) of Brivaracetam diluted in 90 mL 0.9 % isotonic saline sterile solution for intravenous administration infused over 15 minutes twice daily (BID) during Evaluation Period
16198663|NCT01405508|Other|Placebo|100 mg twice daily (BID) for 7 days during Run-In Period
16198664|NCT01405495|Procedure|MRI-based techniques (sMRI, fMRI, DTI, ASL)|no drugs include
16198665|NCT01405482|Drug|Botulinum Toxin Type A|Botulinum Toxin Type A 100 units injected under EMG guidance one time into the anterior,middle scalenes and pectoralis minor muscle
16198666|NCT01405482|Other|Normal Saline injection|10 cc of Normal Saline will be injected under EMG guidance into the Anterior and Middle Scalenes and Pectoralis Minor muscle of individual diagnosed with Thoracic Outlet Syndrome.
16198667|NCT01405469|Other|Peroral Endoscopic Myotomy|A forward-viewing upper endoscope is used with a transparent distal cap attachment. Carbon dioxide gas is necessary for insufflation during the procedures. An endoscopic knife is used to access the submucosa, dissect the submucosal tunnel and also to divide circular muscle bundles over a length of approximately 10cm, extending 2-3cm onto the cardia. An electric generator is used with spray coagulation mode. A coagulating forceps is used for hemostasis as needed. Closure of the mucosal entry site is performed using standard endoscopic clips
16198668|NCT01405456|Drug|Eplerenone and lifestyle|eplerenone 50mg by mouth daily as well as lifestyle counseling
16198669|NCT01405456|Other|placebo and lifestyle|placebo pill daily and lifestyle counseling
16198670|NCT01405430|Biological|Bevacizumab + blood samples|"Bevacizumab will be administered according to investigators appreciation.
~Blood samples will be collected at enrollment, at second bevacizumab's administration and every 10 weeks until progression, or until patients stop bevacizumab because of toxicity or until one year at most in case that patients still receive bevacizumab."
16198671|NCT01405417|Procedure|Endoscopic Peroral Myotomy|Endoscopic peroral myotomy: A forward-viewing upper endoscope is used with a transparent distal cap attachment. Carbon dioxide gas is necessary for insufflation during the procedures. An endoscopic knife is used to access the submucosa, dissect the submucosal tunnel and also to divide circular muscle bundles over a length of approximately 10cm, extending 2-3cm onto the cardia. A electrogenerator is used with spray coagulation mode. A coagulating forceps is used for hemostasis as needed. Closure of the mucosal entry site is performed using standard endoscopic clips.
16198672|NCT01405404|Behavioral|Parent Training and childcare discount|12-session parent training intervention called the Chicago Parent Program; Childcare discount given in one arm to examine its effect on attendance rate
16198673|NCT01405404|Other|Parent Training|12-session group on parenting skills and child behavior management
16198674|NCT01405391|Drug|PM01183|PM01183 drug product (DP) is presented as a lyophilized powder for concentrate for solution for infusion with two strengths, 1 mg and 4 mg vials. Before use, the 1 mg and 4 mg vials should be reconstituted with 2 ml and 8 ml of water for injection respectively, to give a solution containing 0.5 mg/ml PM01183. For administration to patients as an i.v. infusion, reconstituted vials are diluted with glucose 50 mg/ml (5%) solution for infusion or sodium chloride 9 mg/ml (0.9%) solution for infusion.
16198675|NCT01405378|Device|Robot therapy and transcranial direct current stimulation|"Administration of Robot Therapy:
~Therapy will be administered by making use of the Armeo Robot. Sessions will involve high-intensity, repetitive, task-oriented movements directed by video screens. Administration of tDCS:
~Anodal tDCS will be administered using a CE marked transcranial Direct Current Stimulator (Newronika Italy). Direct current will be transferred by a saline-soaked pair of surface sponge electrodes (35 cm2)."
16198676|NCT01405365|Drug|Metronidazole|Metronidazole 400mg TID for 10 days
16198677|NCT01405365|Drug|Placebo|Placebo pill TID for 10 days
16198678|NCT01405365|Procedure|Scaling and root planning|Scaling and root planning performed with curettes and ultrasonic scalers under local anesthesia
16198679|NCT01405352|Dietary Supplement|Vitamin A|"25000 IU/day vitamin A 4 months
~1 Cap/Day
~1 cap placebo/day for 4 month"
16198680|NCT01405339|Device|Mucosal Atomization Device (MAD)|The use of pulmicort via MAD once a day for a total of 30 days.
16198681|NCT01405339|Device|Budesonide via Nasal Syringe|The use of budesonide via Sinus Irrigation Bottle will be once a day for 30 days.
16198682|NCT01405326|Biological|adalimumab|40mg sc. every two weeks for six months
16198683|NCT01405313|Device|Modified Adaptive Servoventilation Device|The modified ASV has a greater adaptive response to meet a target ventilation level that is constantly being assessed.
16198684|NCT01405313|Device|Conventional Adaptive Servoventilation device|Pressure support ventilation adapts to meet a target ventilation level that is constantly being assessed.
16198685|NCT01405300|Dietary Supplement|Control|34.8 g dextrose, 150 g heavy whipping cream, 39g chocolate syrup, 15 g sunflower oil, 22 g safflower oil, 27 g powdered egg whites, 9.6 g of fiber supplement, water and crushed ice. It will deliver ~1200 kcal.
16198686|NCT01405300|Dietary Supplement|Peanut|34.8 g dextrose. 137 g heavy whipping cream, 39g chocolate syrup + 3 oz peanuts with skin. It will deliver ~1200 kcal.
16198687|NCT01405287|Device|PTCA with stent placement|PTCA with stent placement (Drug Eluting Stent)
16198688|NCT01405274|Other|Physiotherapy|Physiotherapy treatment bi-weekly, delivered at the child's home
16198689|NCT01405261|Drug|oral NNC 0113-0987|Subjects will be randomised to receive a single dose of NNC 0113-0987 at escalating dose levels. Progression to next dose will be based on safety evaluation.
16198690|NCT01405261|Drug|oral NNC 0113-0987|Subjects will be randomised to receive a single dose of NNC 0113-0987 at escalating dose levels. Progression to next dose will be based on safety evaluation.
16198691|NCT01405261|Drug|I.v. NNC 0113-0987|Subjects will be administered a single i.v (into the vein) dose. The treatment with NNC 0113-0987 will be open-label, and will not be randomised.
16198692|NCT01405261|Drug|oral placebo|Subjects will be randomised to receive a single dose of placebo.
16198693|NCT01405248|Drug|Butylphthalide|20 mg/time per os three times a day. 180days
16198694|NCT01405248|Drug|Placebo|20 mg/time per os three times a day. 180days
16198695|NCT01405235|Drug|Paclitaxel|Paclitaxel 70 mg/m2/d i.v. on Days 1, 8, and 15 in combination with Topotecan 1.75 mg/m2/d i.v. on Days 1, 8, and 15, q 28 d
16198696|NCT01405235|Drug|Cisplatin/Paclitaxel|Topotecan 0.75 mg/m2/d i.v. on Days 1- 3 in combination with Cisplatin 50 mg/m2 i.v. on Day 1, q 21 d
16198697|NCT01405196|Biological|PF-04236921|subcutaneous injection; administered at day 1, weeks 8, 16.
16198698|NCT01405196|Biological|PF-04236921|subcutaneous injection; administered at day 1, weeks 8, 16.
16198699|NCT01405196|Biological|PF-04236921|subcutaneous injection; administered at day 1, weeks 8, 16.
16198700|NCT01405196|Biological|PF-04236921|subcutaneous injection; administered at day 1, weeks 8, 16
16198701|NCT01405183|Other|Hepatitis C testing|Hepatitis C antibody, Hepatitis C RNA quantitative and for those who test positive Hepatitis C genotype
16198702|NCT01405170|Drug|methylprednisolone|constituted powder for oral suspension 4 mg/mL single dose at 32 mg
16198703|NCT01405170|Drug|methylprednisolone|tablets 32 mg single dose
16198704|NCT01405157|Drug|methylprednisolone|constituted powder for oral suspension 4 mg/mL single dose at 16 mg
16198705|NCT01405157|Drug|methylprednisolone|tablets 16 mg single dose
16198706|NCT01405144|Drug|5-fluoruracil|5% 5-fluoruracil cream, twice a day, during 3 weeks
16198707|NCT01405144|Procedure|5-fluoruracil|The same 30 patients will be submitted to 4 weekly application of superficial peeling using 5% 5-fluoruracil in propyleneglycol as vehicle. The applications will be performed by physician (one of the co-investigators)
16198708|NCT01405131|Drug|methylprednisolone|constituted powder for oral suspension 4 mg/mL single dose at 32 mg
16198709|NCT01405131|Drug|methylprednisolone|tablets 32 mg single dose
16198710|NCT01405118|Drug|Metformin/CP-690,550|Single oral 500 mg dose of metformin on Days 1 and 4 and multiple oral 30 mg doses of CP-690,550 every 12 hours on Days 2-4.
16198711|NCT01405092|Device|use of continuous renal replacement machine for renal replacement|usual care with volume removal during continuous renal replacement therapy
16198712|NCT01405092|Device|use of blood volume monitoring device in conjunction with machine used for continuous renal replacement to assess and determine volume removal|blood volume monitoring device, Critline, Hemametric, USA, will be used in conjunction with continuous renal replacement to determine rate of volume removal
16198713|NCT01405079|Drug|Gefitinib|Gefitinib 250 mg/day oral daily
16198714|NCT01405079|Drug|Vinorelbine+Cisplatin|Vinorelbine 25 mg/m2 intravenous infusion on day 1 and day 8, Cisplatin 75 mg/m2 on day 1 for 4 cycles
16198715|NCT01405066|Behavioral|Radiation Dose Audit Reports|Audit reports by CT technologist, with graphs of radiation dose levels of 20 exams from each of the 4 most common CT exams. Reports show the distribution of radiation dose levels by each exam type, and compares the technologist's dose levels to the overall levels from the clinic where they work and to the United Kingdom's 2003 Reference Dose. Prior to the graphs, the reports include an introductory page explaining the organization of the report and defining the dosimetry metrics. The final page of the report lists exams meriting individual review because their doses are higher than that of the clinic averages.
16198716|NCT01405066|Behavioral|Educational Seminar: Radiation Dose Reduction|Seminar led by a Radiologic Physicist and Radiologist. Discussion of the parameters associated with radiation dosage from CT exams and methods for changing these parameters to lower radiation dose.
16198717|NCT01405053|Drug|Rufinamide|Rufinamide up to 45 mg/kg/day, in 2 divided doses, administered as oral suspension (40 mg/mL) as an add-on to the subject's existing regimen of 1-3 antiepileptic drugs (AEDs)
16198718|NCT01405053|Drug|Any other approved Antiepileptic Drug|Any other approved AED: any other approved AED of the investigator's choice as an add-on to the subject's existing regimen of 1-3 anti-epileptic drugs (AEDs)
16198719|NCT01405027|Procedure|Educational Intervention|Receive patient education and management skills training from Hepatology Centers of Educational Expertise (HCEE) during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes.
16198801|NCT01404442|Drug|Ketamine|The ketamine group (groupK) received bupivacaine 10mg combined with 0.1 mg/kg ketamine preservative free intrathecally
16198720|NCT01405027|Other|Patient education and management skills training|Community sites received patient education and management skills training by HCEE investigators during four (4) educational interventions.The CLDF (Sponsor) intends to evaluate the effectiveness of the HCEE led educational interventions in improving a community site's HCV therapeutic management skills and patient outcomes.
16198721|NCT01405014|Behavioral|Hold Me Tight|Relationship enhancement group
16198722|NCT01404988|Behavioral|Telephone-Delivered BI|Behavioral Intervention will be delivered over the phone.
16198723|NCT01404988|Behavioral|Telephone-Delivered BEI|Behavioral and Environmental Intervention will be delivered over the phone
16198724|NCT01404988|Other|Telephone-Delivered API|Attention Placebo Intervention will be delivered over the phone
16198725|NCT01404975|Other|Thoracic paravertebral block (PVB)|"We are planning to replace the standard intravenous opioid analgesia with a continuous paravertebral block using local anesthetic after trans-apical aortic valve replacement.
~Anesthesia management will be standardized to minimize any impact that anesthetic type may have on neurological outcomes.
~Adjuvant supplemental analgesia will be provided to both groups according to the standardized institutional guidelines."
16198726|NCT01404962|Biological|Haemophilus influenza type b conjugate vaccine|Primary series is 3 doses given to infants beginning at 2 months of age with an interval of 2 months apart (i.e. 2, 4 and 6 months of age). Booster vaccination consists of 1 dose and is given to toddlers 16 to 20 months of age. In this study, subjects will receive vaccination from routine primary care.
16198727|NCT01404949|Drug|Tretinoin and Arsenic Trioxide|See Detailed Description
16198728|NCT01404936|Drug|Interferon-2A|4 (x106 IU/m^2) subcutaneously on days 1-4.
16198729|NCT01404936|Drug|Adriamycin|25 mg/m^2 by vein on day 4.
16198730|NCT01404936|Drug|Bleomycin|10 mg/m^2 by vein on day 4.
16198731|NCT01404936|Drug|Velban|6 mg/m^2 by vein on day 4.
16198732|NCT01404936|Drug|Dacarbazine|375 mg/m^2 by vein on day 4.
16198733|NCT01404923|Drug|anti spasmodic agents|best standard of care prescriptions
16198734|NCT01404923|Drug|alverine citrate, simeticone|on-demand therapy
16198735|NCT01404910|Device|Apheresis using Liposorber LA-15 System|The Liposorber LA-15 Device is a dextran sulfate cellulose column, one of several currently approved in Europe and United States for pheresis of lipoproteins in the treatment of familial hypercholesterolemia. Such devices have been in use for over 30 years. Published experience in pregnant women with familial hypercholesterolemia suggests that lipoprotein pheresis can be safely used in pregnancy after appropriate individual benefit/risk assessment for both mother and fetus is considered. The Liposorber LA-15 system selected for this trial has been evaluated for its ability to efficiently and selectively remove sFlt-1 in vitro.
16198736|NCT01404897|Other|Dietary Intervention|3 weeks of a typical Western diet pattern. 48% carbohydrate, 15% protein, 37% fat.
16198737|NCT01404897|Other|Dietary Intervention|3 weeks of a diet based on the Dietary Approaches to Stop Hypertension (DASH) diet plan. 57% carbohydrate, 18% protein, 25% fat.
16198738|NCT01404897|Other|Dietary Intervention|3 weeks of a reduced carbohydrate, higher fat modification of the DASH diet plan. 42% carbohydrate, 18% protein, 40% fat.
16198739|NCT01404884|Procedure|SUPRACOR|The developed software algorithm uses the subjective refraction of the eye to create a treatment for the distance vision correction. In addition to the treatment for the distance vision an additional central ablation component will be added to address the near vision.
16198740|NCT01404871|Drug|clomipramine|oral tablets, starting at 50mg/daily for 12 weeks including > 8 weeks at 250 mg/daily
16198741|NCT01404871|Drug|escitalopram|oral tablet, starting 10mg/daily 12 week treatment including >8 weeks at max dose 50mg daily
16198742|NCT01404871|Drug|duloxetine|oral tablets, starting dose 30mg daily 12 week treatment including >8weeks at 120mg daily
16198743|NCT01404858|Behavioral|There is no intervention; this is a survey only study|There is no intervention; this is a survey only study
16198744|NCT01404845|Dietary Supplement|Nutrof Total|Nutrof Total : 2 capsules per day,during 8 months (5 mg Lutéine + 1 mg Zéaxanthine / capsule).
16198745|NCT01404845|Dietary Supplement|food supplement without Lutein and Zeaxanthin|food supplement without Lutein and Zeaxanthin : 2 capsules per day, during 8 months.
16198746|NCT01404832|Drug|Treat with lansoprazole 30 mg BID for 2 weeks, endoscopic examination with esophageal biopsy for patients with persistent symptoms|Treat with lansoprazole 30 mg BID for 2 weeks, perform endoscopic examination with esophageal biopsy
16198747|NCT01404819|Drug|Anesthesia with Xenon|Patients undergo anesthesia with xenon (remifentanil with xenon).
16198748|NCT01404819|Drug|Standard anesthesia|Patients undergo standard anesthesia (remifentanil with propofol)
16198749|NCT01404806|Drug|GSK1349572 (dolutegravir)|Subjects will take an oral daily 50mg dose of GSK1349572 for 5-7 days. GSK1349572 in the CVF and BP will be measured over 24 hours after both the initial dose, and once steady state is reached 5-7 days later at the following time points: 0 (pre-dose) 1, 2, 3, 4, 5, 6, 8, 12, 18, and 24h. Cervical and vaginal biopsies will be collected once at initial dose at either 3, 6, 12 or 24 hours post dose, and again at steady state at the same single time point. Samples will be collected from 2 subjects per time point. BP and CVF samples will be obtained at 48 and 72 hours following the final GSK1349572 dose.
16198750|NCT01404793|Drug|Rocuronium|After insertion of the new liver and restoration of portal venous flow, 0.6 mg kg-1 rocuronium will be administered
16198751|NCT01404780|Device|GlideScope (GVL)|The Glidescope (GVL) has not been extensively studied for double lumen tube intubation. The GVL may be particularly useful for patients with difficult airways as it has a camera attached to the blade.
16198752|NCT01404780|Device|Macintosh Direct Laryngoscope (MDL)|Current standard of care at UHN for 50 years
16198753|NCT01404767|Drug|Esmolol|Baseline treatment consists of a bolus of 500ug/kg/min followed by an infusion of 50ug/kg/min for 4 minutes and titrating in increment of 50ug/kg/min up to a maximum of 300ug/kg/min to maintain a HR within 10% of the target HR (≤ 70 bpm), which is 70± 7 bpm.
16198754|NCT01404767|Drug|Metoprolol|The night and morning before surgery, the patients in the metoprolol arm will receive their standard dose of beta blocker metoprolol.These patients will receive their daily beta blockers orally or via nasogastric tube postoperatively if they are NPO (Group A).
16198755|NCT01404754|Drug|Lactose (inactive placebo)|Placebo in an equivalent weight to MDMA will be administered in identical appearing capsules during one of two experimental sessions. An equivalent to the initial and supplemental dose will exist.
16198756|NCT01404754|Drug|3,4-methylenedioxymethamphetamine|125 mg MDMA will be administered in opaque capsules at the outside of one of two experimental sessions, and upon mutual agreement between the investigator and participant, 62.5 mg may be administered 1.5 to 2.5 hours later.
16198757|NCT01404741|Procedure|allogeneic stem cell transplantation|donor available, after 4 cycles 5-azacytidine allogeneic stem cell transplantation after reduced conditioning
16198758|NCT01404741|Procedure|5-azacytidine until progress|if no donor available 5-azacytidine until progress or toxicities
16198759|NCT01404715|Drug|Metformin|Subjects will be given an oral dose of 1000 mg of metformin followed by an oral dose of 850 mg for a grand total of 1850 mg in both study Arm 1 and study Arm 2.
16198760|NCT01404715|Drug|Imatinib|A single oral dose of 600 mg of imatinib
16198761|NCT01404702|Drug|Zoledronic Acid|4 mg/m2/dose given iv on day 0 of every 28 day cycle
16198762|NCT01404702|Biological|Aldesleukin|"Dose Level 1: 3 x 10^6 IU/m2/day given subcutaneously on days 0 through 4 and 14 through 18 every 28 day cycle
~Dose Level 2: 6 x 10^6 IU/m2/day given subcutaneously on days 0 through 4 and 14 through 18 every 28 day cycle"
16198763|NCT01404689|Drug|Dexmedetomidine|dexmedetomidine 1μg/Kg•hr IV continuous infusion, initiated 15 min before the procedure (ERCP) till complete procedure
16198764|NCT01404689|Other|normal saline|0.9% NaCl 1μg/Kg•hr IV continuous infusion, initiated 15 min before the procedure (ERCP) till complete procedure
16198765|NCT01404676|Drug|Add Vildagliptin|Adding Vildagliptin 50 mg bid to patients with type 2 diabetes mellitus being treated with metformin 500-1000mg bid per day who had hemoglobin A1c of 7.0-10.0%
16198766|NCT01404676|Drug|Add Glimepiride|Adding Glimepiride 2mg to patients with type 2 diabetes mellitus being treated with metformin 500-1000mg bid per day who had hemoglobin A1c of 7.0-10.0%
16198767|NCT01404663|Biological|CD133 stem cell injection|Bone marrow derived CD133 stem cell witch are transplanted by intrathecal injection
16198768|NCT01404650|Drug|AUY922|AUY922: 70 mg/m2 IV over 60 minutes on Days 1, 8, and 15 of each cycle. Treatment cycles will be repeated every 21 days. Patients will be evaluated for response at 6 and 12 weeks and then every 9 weeks (i.e., every 3 cycles) thereafter. Patients may continue treatment until evidence of disease progression.
16198769|NCT01404637|Drug|Tamsulosin 0.4mg|Treatment: tamsulosin 0.2mg (2T) /day Posology: two 0.2 mg tablet to be taken after an evening meal.
16198770|NCT01404637|Drug|Tamsulosin 0.2mg|tamsulosin 0.2mg (1T) /day Posology: one tablet to be taken after an evening meal.
16198771|NCT01404611|Drug|DF289|Ear drops
16198772|NCT01404611|Drug|DF277|Ear drops
16198773|NCT01404611|Drug|DF289 plus DF277|Ear drops
16198774|NCT01404598|Drug|naproxcinod 750 bid|naproxcinod 750 bid
16198775|NCT01404598|Drug|naproxcinod 3000 mg od|naproxcinod 3000 mg od
16198776|NCT01404598|Drug|naproxen 500 mg bid|naproxen 500 mg bid
16198777|NCT01404585|Drug|Placebo|Tablets, Oral, 0 mg, twice daily, 12 weeks
16198778|NCT01404585|Drug|BMS-817399|Tablets, Oral, 200 mg, twice daily, 12 weeks
16198779|NCT01404585|Drug|BMS-817399|Tablets, Oral, 400mg, twice daily, 12 weeks
16198780|NCT01404572|Drug|Atazanavir (current formulation)|Solution, oral, atazanavir 15 mg/5 mL with 10% aspartame, single dose
16198781|NCT01404572|Drug|Atazanavir, powder for oral use 1 (POU1)|Solution, oral, atazanavir 15 mg/5 mL with 4.2% aspartame, single dose
16198782|NCT01404572|Drug|Atazanavir (POU2)|Solution, oral, atazanavir 15 mg/5 mL with 4.2% aspartame and sucralose, single dose
16198783|NCT01404559|Device|Ossur Variflex prosthetic foot|Lightweight energy-storing prosthetic foot
16198784|NCT01404559|Device|Ossur Ceterus prosthetic foot|Shock-absorbing prosthetic foot
16198785|NCT01404559|Device|Endolite Elite Blade prosthetic foot|Multi-axial prosthetic foot
16198786|NCT01404546|Other|cost free pharmacotherapy|Participants assigned to the CF group received a starter kit (4-week supply) of cost-free quit smoking medication (nicotine replacement therapy, bupropion, or varenicline) and a pre-printed prescription to be filled by the patient at the end of the 4-weeks.
16198787|NCT01404546|Other|usual care|Participants assigned to the prescription only usual care group received a prescription for smoking cessation pharmacotherapy to be filled at their own cost at their local community pharmacy.
16198788|NCT01404533|Dietary Supplement|Ferrous sulfate|60 mg Ferrous sulfate
16198789|NCT01404533|Dietary Supplement|Ferrous sulfate|60 mg ferrous sulfate
16198790|NCT01404533|Dietary Supplement|Ferrous sulfate|6 mg ferrous sulfate
16198791|NCT01404520|Other|Exercise based multimodal intervention|The intervention is initiated early, during treatment (consolidation) in the intra-hospital setting and continues for two successive treatment series (12 weeks). The intervention is a three hour/wk supervised in-hospital programme of aerobic (stationary cycle) and functional muscle training, progressive relaxation training, nutrition supplement (protein and carbohydrate) immediately after training and health-promoting consultation combined with an unsupervised in-home walking and progressive relaxation programme.
16198792|NCT01404507|Drug|Gp 2b 3a inhibitor|bolus injection of abciximab via intracoronary route single injection during primary PCI dosage : 0.25mg/kg
16198793|NCT01404507|Device|aspiration thrombectomy|Aspiration thrombectomy via aspiration catheter
16198794|NCT01404507|Other|Both use|Both use of intracoronary abciximab and aspiration thrombectomy
16198795|NCT01404481|Device|clean intermittent self catheterisation single use vs re use|Over the 16 week period all patient will participate in 8 weeks of single use cathetersation and 8 weeks of re use catheterisation. The study is a randomised control crossover trial
16198796|NCT01404468|Device|pulsed ultrasound device with lidocaine|Lidocaine (approximately 2 cc) was administered transdermally using a transducer (pulsed ultrasound)
16198797|NCT01404468|Other|off device|off device with Lidocaine (approximately 2 cc) was administered transdermally
16198798|NCT01404468|Device|continuous ultrasound device with lidocaine|Lidocaine (approximately 2 cc) was administered transdermally using a transducer (continuous ultrasound )
16198799|NCT01404455|Other|HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loading|HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loading during 15 minutes after induction of anesthesia
16198800|NCT01404442|Drug|placebo(distilled water|The placebo group (group P) received bupivacaine 10mg combined with 0.5ml distilled water intrathecally .
16198802|NCT01404442|Drug|Midazolam|The midazolam group (group M) received bupivacaine 10mg combined with0.02 mg/ kg midazolam intrathecally
16198803|NCT01404429|Drug|Methotrexate|Different doses for both arms followed by similar escalation (2.5 mg every 15 d) till max of 25 mg per week or 3 months completed
16198804|NCT01404403|Device|Rapid System|
16198805|NCT01404390|Drug|BAY80-6946|0.4mg/ kg, iv, day 1,8 and 15, every 28 days
16198806|NCT01404390|Drug|BAY80-6946|0.8mg/ kg, iv, day 1,8 and 15, every 28 days
16198807|NCT01404377|Procedure|infiltration with ropivacaine solution|Patients are allocated randomly into two arms on the morning of surgery, using random numbers and sealed envelopes. In the treated group infiltration is performed with a ropivacaine 7.5 mg.ml-1 solution and in the control group with an isotonic saline solution. In the two groups patients are operated under and nitrous oxide for maintenance. Dexamethasone 4 mg was given intravenously after anaesthetic induction for prevention of postoperative nausea and vomiting. Twenty milliliters of the allocated solution were used at the end of the surgical procedure to infiltrate the subcutaneous and deep layers at the level of the breast and axilla surgical incision.
16198808|NCT01404364|Drug|Triamcinolone|0,3mL intravitreal injection of Triamcinolone, single dose
16198809|NCT01404364|Drug|Chlorpromazine|2,5mL Chlorpromazine retrobulbar injection, single dose
16198810|NCT01404351|Device|PEAK PlasmaBlade|
16198811|NCT01404351|Procedure|Scalpel and Traditional Electrosurgery|
16198812|NCT01404338|Drug|Halobetasol 0.05% ointment|
16198813|NCT01404338|Drug|Placebo Ointment|
16198814|NCT01404325|Drug|standard therapy|centre specific CNI-based triple drug immunosuppression
16198815|NCT01404325|Drug|Everolimus|quadruple immunosuppressive regimen consisting of everolimus, CNI, MPA and steroids
16198816|NCT01404312|Drug|Rifapentine (RPT)|"RPT dosing was be based on participants' weight:
~Participants who weighed 30 kg to less than 35 kg received 300 mg once daily (administered as two 150-mg tablets).
~Participants who weighed 35 kg to less than 45 kg received 450 mg once daily (administered as three 150-mg tablets).
~Participants who weighed greater than 45 kg received 600 mg once daily (administered as four 150-mg tablets)."
16198817|NCT01404312|Drug|Isoniazid (INH)|Participants received one 300-mg tablet or three 100-mg tablets of INH once daily.
16198818|NCT01404312|Dietary Supplement|Pyridoxine (Vitamin B6)|"Participants received 25 mg or 50 mg of pyridoxine, based on the current local, national, or international dosing guidelines.
~Participants who received 25 mg of pyridoxine took one 25-mg tablet once daily with INH.
~Participants who received 50 mg of pyridoxine took two 25-mg tablets once daily with INH."
16198819|NCT01404299|Dietary Supplement|Nutritional Supplementation|- Providing two 200mL per day of commercial liquid formula cans for 12 weeks (additional 400kal of energy, 25g of protein, 9.4g of essential amino acids (60.2% leucine), 400mL of water, and micronutrients per day)
16198820|NCT01404299|Other|Control|- No intervention, except monthly home visits
16198821|NCT01404286|Behavioral|Physical exercise|After the adaptation sessions, volunteers underwent a session of resistance training at 60% of 1 RM organized as follows: 3 sets of 10 to 12 repetitions on each exercise machine with a 1 minute and 30 second interval between each set and an interval of 2 minutes between each exercise machine, giving a total duration of training between 50 and 60 minutes. The sequence of exercise machines used was alternated by body segment. The sessions were performed at the same time of day (morning) under controlled temperature conditions (24 ± 21C).
16198822|NCT01404273|Behavioral|Meditation/Relaxation Response Training|1 hour weekly sessions with 20 min daily home practice for 6 weeks
16198823|NCT01404260|Drug|Gefitinib|Gefitinib 250mg/d every cycle d15-25,and Gefitinib 250mg/d from d15 of last cycle until disease progression
16198824|NCT01404260|Drug|Gemcitabine +Carboplatin|Gemcitabine 1250mg/m2+Carboplatin AUC=5, every 4 weeks, maximum 4 cycles
16198825|NCT01404247|Other|Observational: to better characterize the retina and optic nerve in newborns using spectral domain optical coherence tomography (s-oct).|The OCT technician will attempt to image the eyes of neonates. The neonate may be given Cyclomydril ophthalmic solution, if needed for dilation. Cyclomydril dosing for this study is 1 drop every 5 minutes times 2.
16198826|NCT01404247|Procedure|OCT imaging.|All newborns meeting eligibility requirements will undergo spectral domain optical coherence tomography imaging in order to better characterize the retina and optic nerve in newborns
16198827|NCT01404234|Drug|AZLI|AZLI 75 mg was administered 3 times daily via the investigational nebulizer.
16198828|NCT01404208|Drug|D-Cycloserine|25mg dose for children weighing between 22.5kg and 45kg (dose = approx. .7mg/kg) 50mg dose for children weighing greater than 46kg (dose = approx. .7mg/kg) Dose given 7 times, every seven days, except for the third dose, which will be given three days after the second dose. All doses given 1 hour prior to therapy session.
16198829|NCT01404208|Drug|Placebo|Sugar pill
16198830|NCT01404195|Dietary Supplement|Ensure Plus Advance|Participating patients will be dispensed two small bottles daily, one at breakfast and one in the evening, seven days a week
16198831|NCT01404182|Biological|Vaccination with Fluval AB influenza vaccine|Vaccination with a single dose of Fluval AB influenza vaccine (trivalent, seasonal, active ingredient content: 15 μg HA/0.5mL of seasonal H1N1, H3N2 and B influenza antigens each) and aluminium phosphate gel adjuvant.
16198832|NCT01404169|Drug|E2020|In titration period, donepezil 5-mg tablet will be taken orally once daily for 6 weeks, following donepezil 10 mg tablets taken orally once daily for 18 weeks in the maintenance period.
16198833|NCT01404169|Drug|Placebo|Placebo matched to donepezil 5 mg or 10 mg tablets taken orally once daily for 24 weeks.
16198834|NCT01404156|Drug|(Epirubicin Cisplatin 5-Fluorouracil / Xeloda) OR 5-Fluorouracil Leucovorin Oxaliplatin Docetaxel|"NEOADJUVANT CHEMOTHERAPY (OPTION of CHEMO REGIMEN 1 or 2)
~1) FLOT - Four x 14 day cycles FLOT preoperatively and 4 cycles postoperatively (within 4-10 weeks after surgery): 5-Fluorouracil 2600 mg/m², day 1 IV every 14 days Leucovorin 200 mg/m², day 1, IV., every 14 days Oxaliplatin 85 mg/m², day 1, IV, every 14 days Docetaxel 50mg/m2, day 1, IV, every 14 days
~2) ECF / ECX - Three x 21-day cycles ECF preoperatively and 3 cycles postoperatively (within 4-10 weeks after surgery): Epirubicin (50 mg/m²,mg per square meter of body-surface area) by intravenous bolus on day 1 IV Cisplatin: 60 mg/m², mg per square meter intravenously with hydration on day 1 IV 5-Fluorouracil: 200 mg/m², mg per square meter daily for 21 days by continuous IV infusion 5-FU may be substituted with Capecitabine (Xeloda) 625mg/m2, PO BID (ECX)"
16198893|NCT01403662|Drug|Minocycline|Minocycline (100 mg bid) will be administered as an adjunctive agent to conventional Health Canada-approved, or first-line CANMAT bipolar guideline-recommended, agents for bipolar disorder.
16198835|NCT01404156|Other|Carboplatin paclitaxel plus concurrent radiotherapy|"5 cycles carboplatin and paclitaxel given on days 1, 8, 15, 22 and 29 preoperatively:
~paclitaxel: 50 mg / m2 IV over 1 hour
~carboplatin: dosed to an area under the curve of 2, by Calvert formula, as a 1 hour IV infusion
~Radiation Therapy Concurrent radiation therapy will begin within 24 hours of initiation of chemotherapy for patients randomized to chemoradiation treatment.
~1. Dose specifications:
~Phase 1: Total radiation prescription dose 45 Gy given in 25 fractions of 1.8 Gy per fraction, 5 fractions / week, one treatment / day, starting on the first day of first cycle of chemotherapy. This total radiation dose option is acceptable if boost dose is not possible due to clinical reasons or dosimetric constraints.
~Phase 2: (GTV only) Boost is not mandatory and up to the discretion of radiation oncologist. Total radiation prescription dose 5.4 Gy given in 3 fractions of 1.8 Gy per fraction, 5 fractions / week, one treatment ."
16198836|NCT01404143|Procedure|Subscapularis Tenotomy|After the deltopectoral approach is completed, the subscapularis tendon will be tenotomized one centimeter medial to its insertion on the lesser tuberosity. The tendon will be tagged for later repair. Repair will take place with a combination of transosseous sutures (3) placed in a mattress configuration through the area of exposed lesser tuberosity. In addition, a soft tissue tendon to tendon repair will be carried out using figure-8 stitches using #2 (heavy) non-absorbable suture (Ticron).
16198837|NCT01404143|Procedure|subscapularis peel|The subscapularis will be elevated from the lesser tuberosity. The tendon will be tagged with stay sutures for later reattachment (3 sutures in mattress configuration). Reapproximation will take place with three non-absorbable mattress sutures placed in a trans-osseous fashion through the bicipital groove, exiting the greater tuberosity and tied over a 4-hole mini-fragment plate.
16198838|NCT01404130|Drug|Isotretinoin|0.5-1mg/kg daily for 4-6 months
16198839|NCT01404117|Drug|Laquinimod 0.6|Laquinimod 0.6 capsule
16198840|NCT01404117|Drug|Laquinimod 1.2|Placebo
16198841|NCT01404117|Other|Glatiramer Acetate or interferon-beta+ Placebo|GA 20 mg/1mL or IFN-B (Avonex®, Betaseron®/Betaferon®, Rebif® or Extavia®) + oral daily placebo
16198842|NCT01404104|Drug|Temsirolimus (pre surgery)|Temsirolimus will be given to patients 12 weeks prior to surgery (with a one week off period right before the surgery date).
16198843|NCT01404091|Drug|LY2940094|Administered orally
16198844|NCT01404078|Drug|Single Dose Polycap|Low strength polycap contains Ace inhibitor; betablocker; thiazide diuretic; statin; aspirin
16198845|NCT01404078|Drug|Double dose Polycap|2 Capsules of low strength polycap with 30mEq of Potassium
16198846|NCT01404065|Procedure|Transcranial Direct Current Stimulation (tDCS)|Subjects will undergo tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2, at an intensity of 2mA. For active tDCS, the subject will undergo stimulation for 20 minutes. For sham stimulation, the current will be ramped up and then down again (for 30 seconds total) to simulate the feeling of active stimulation.
16198847|NCT01404052|Device|Transcranial Direct Current Stimulation|Subjects will be randomized to undergo either 5 sessions of active tDCS stimulation, or 5 sessions of sham tDCS stimulation. For both active and sham stimulation, we will use electrodes of 35cm^2 and an intensity of 2mA. The anodal electrode will be placed over the primary motor cortex contralateral to the most painful side, and the cathodal electrode will be placed over the contralateral supraorbital area. Active stimulation will last for 20 minutes, while sham stimulation will only last for 30 seconds, mimicking the sensations during active stimulation.
16198848|NCT01404039|Behavioral|Motor Learning|Subject will have to draw a set of shapes and words during 20 minutes.
16198849|NCT01404039|Behavioral|Somatosensory Learning|Subjects will perform a learning task involving sensory activation of the hand. The task will consist of learning letters of Braille.
16198850|NCT01404039|Behavioral|Observational Task|Subjects will watch a 10 second video of a right-handed person performing movements of their left index finger. Subjects will be instructed to watch the video without any other specific instruction.
16198851|NCT01404039|Behavioral|Mental Imagery|Subjects will be asked to perform mental imagery of motor practice - finger movements of the left hand for 10 minutes.
16198852|NCT01404039|Device|transcranial direct current stimulation|Subjects will undergo active and sham tDCS stimulation in a randomized and counterbalanced order. During both active and sham stimulation, we will use electrodes of 35cm^2, intensity of 2mA for a duration of 20 minutes. The anode electrode will be placed over the right primary motor cortex (M1) and the cathode will be placed over the contralateral supraorbital area. For active stimulation, the current will be on for the duration of 20 minutes. For sham stimulation, the current will ramp up, and then down again for 30 seconds to simulate the sensation of active tDCS.
16198853|NCT01404026|Device|Transcranial Direct Current Stimulation (tDCS)|Subjects will undergo tDCS stimulation. For both active and sham stimulation we will use electrodes at 35cm^2, with an intensity of 2mA. The anodal electrode will be placed over the primary motor cortex, and the cathode will be placed over the contralateral supraorbital area. For active stimulation, the current will be active for the duration of 20 minutes. For sham stimulation, the current will only be active for 30 seconds, simulating the sensations of active stimulation.
16198854|NCT01404013|Drug|ICS/LABA|Budesonide 160µg and Formoterol 4.5µg, 1puff ,twice a day, for 8 weeks
16198855|NCT01404013|Drug|Montelukast|Montelukast 10mg ,every night, for 8 weeks
16198856|NCT01404013|Drug|ICS/LABA and Montelukast|Budesonide 160µg and Formoterol 4.5µg, 1puff, twice a day, for 8 weeks; Montelukast 10mg ,take orally ,every night for 8 weeks
16198857|NCT01404000|Drug|Iodinated Active Charcoal (IodoCarb)|3 g will be given as an oral suspension once daily for 56 days
16198858|NCT01403987|Behavioral|Residency Program Teaching|The residency program provides education surrounding the management of ascites to all house-staff in the training program. This consists of lectures, case-based or bedside discussions, and board review. All arms will receive the standard teaching provided by the residency program.
16198859|NCT01403987|Behavioral|Lecture|During resident rotations on inpatient wards there are typically several dedicated, one-hour discussions facilitated by the team's supervising attending, addressing a variety of internal medicine topics. In place of or in addition to one of these discussions, a gastroenterology fellow will meet with the team for one hour to discuss a standardized case of a patient with ascites and the management issues. At this time they will review the consensus guidelines for management, and be provided with a pocket card with key points.
16198964|NCT01403103|Genetic|protein expression analysis|Correlative studies
16200531|NCT01390571|Other|laboratory biomarker analysis|
16198860|NCT01403987|Other|Pocket Card Reference|A 4x6 inch laminated card will be administered to both intervention arms at the beginning of the study. The card will contain a brief summary of AASLD guidelines, indications for and contraindications to paracentesis, and key studies to order for fluid analysis. The organization of residency rotations is such that members of one randomization group do not typically work with members of other groups, however in the event that there is crossover, they will be free to share information as they see fit in order to optimize patient care.
16198861|NCT01403987|Behavioral|Pager|"The intensive education arm will be given a pager number at their initial meeting that they can use to call for personal assistance with performing paracentesis. Since a paracentesis is frequently referred to by housestaff as a tap, the pager number will correlate with the letters, TAPS, or #8277. The goal of the pager is to provide supervision and individual teaching so that the care provider can become proficient in the procedure."
16198862|NCT01403974|Drug|BI 836845|Intravenous infusion once every week
16198863|NCT01403948|Drug|BI 836826|Monotherapy with BI 836826 at escalating dose levels administered as an intravenous infusion
16198864|NCT01403922|Drug|TC-5214|Tablet oral bid days 1 to 7
16198865|NCT01403922|Drug|TC-5214|Tablet oral bid days 8 to 14
16198866|NCT01403909|Device|Intermittent pneumatic compression|Intermittent pneumatic venous compression is applied to the lower limbs of patients during surgery.
16198867|NCT01403909|Procedure|Standard care|Intermittent pneumatic venous compression is not applied to the lower limbs of patients during surgery.
16198868|NCT01403896|Drug|Plerixafor (Mozobil)|They will receive Plerixafor (240 µg/kg/day subcutaneously for 1 dose) on Day 0 at 8 am
16198869|NCT01403896|Drug|Plerixafor + G-CSF|They will receive G-CSF (5 µg/kg/day) for 4 days (Days -4,-3,-2,-1 at 8 am) followed by Plerixafor (240 µg/kg/day subcutaneously for 1 dose) on Day 0 at 8 am
16198870|NCT01403883|Behavioral|Standard Care|Psychological & enterostomal therapy clinics on demand only
16198871|NCT01403883|Behavioral|Optimal care (Psychological and enterostomal therapy clinics)|Psychological clinics at D-45, D0, D45, D60, D90 enterostomal therapy clinics at D-45, D0, D45, D60
16198872|NCT01403870|Other|Physical Therapy|The physician will complete a physical exam as well as analyze a completed CERSR scan study to determine the root cause of the low back pain. The physician will then prescribe a targeted physical therapy regime to address the cause of the low back pain.
16198873|NCT01403857|Other|Whole grain foods|Eight commonly consumed whole grain products that meet the consumers Dietary Guidelines recommendations for a period of six weeks.
16198874|NCT01403857|Other|Refined grains|Eight commonly consumed refined grain products given in amounts that fulfill the consumer's Dietary Guidelines for Americans recommendation over the course of six weeks.
16198875|NCT01403844|Other|Carotenoid Depletion|Depletion of carotenoids using a restricted food list
16198876|NCT01403844|Other|Carotenoid Repletion|Carotenoid repletion with provided diet based on dietary guidelines.
16198877|NCT01403844|Other|Carotenoid Depletion|Carotenoid depletion using a restricted food list.
16198878|NCT01403844|Other|Natural Repletion|Resumption of usual personal diet regimen. No restrictions.
16198879|NCT01403831|Other|Daily text messages|2-3 times daily text messages regarding diabetes care and healthy lifestyle choices
16198880|NCT01403818|Drug|ASP1941|oral
16198881|NCT01403818|Drug|Mitiglinide calcium hydrate|oral
16198882|NCT01403805|Biological|Pneumococcal vaccination (Pneumovax NP, 21800AMY10131000)|Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day
16198883|NCT01403805|Biological|Influenza vaccination (Flubik HA, 16100EZZ01207000)|Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day
16198884|NCT01403805|Biological|Influenza vaccination (Flubik HA, 16100EZZ01207000)|Injection,subcutaneous,0.5ml,ones,Planned duration of intervention:a day
16198885|NCT01403805|Other|Specific frequency of oral care|1 dentist and 2 dental hygienists visited the nursing home once a week. After the residents agreed our receive oral care, the dentist/dental hygienist spent 15 minutes with brushing of teeth, scaling, oral wiping, gargling and cleaning of dentures, to reduce dental plaque which is oral bacteria mechanically by using cleaning tools, including toothbrush, interdental brush, dental scaler, tongue brush, and sponge brush to treatment of periodontal disease at the washstand in their private room primary care physicians. At the same time, they taught and recorded to the nursing care workers the methods of administering responsible oral care to dye for dental plaque by using plaque disclosing agent material.
16198886|NCT01403792|Drug|P2G12|A single intravaginal administration of 1ml P2G12/placebo.
16198887|NCT01403779|Radiation|intensity modulated radiotherapy (IMRT) for breast cancer|right sided breast cancer patients are stratified to receive a hypofractionated treatment course (40.05 / 2.67Gy in 15 fractions) and the left sided breast cancer patients a normofractionated irradiation (50/2Gy in 25 fractions). In both arms, patients between 60-69 years are to receive a boost (16 Gy / 2Gy).
16198888|NCT01403740|Drug|rFVIIIa, aPCC, FVIII, DDAVP, Azathioprine, Rituximab, Cyclosporin|According to local clinical standards
16198889|NCT01403714|Procedure|Renal Artery Stenting|If the patient has a hemodynamically significant renal artery stenosis, and they are randomized to renal artery stenting, they will undergo renal artery stenting
16198890|NCT01403701|Behavioral|Physical therapy|pelvic floor physical therapy
16198891|NCT01403688|Procedure|RPFNA|"Baseline RPFNA within 3 month prior to the initial COH cycle or within the first 10 days of the treatment cycle (delete this).
~Repeat RPFNA if pregnancy is not achieved: 6 to 18 months following baseline assessment
~Repeat RPFNA if pregnancy is achieved: approximately 12 months after discontinuation of breast feeding"
16198892|NCT01403675|Procedure|Ovarian autotransplantation|There are two ways to transplant the thawed ovarian tissue back into a woman's body. It can be put back inside the abdomen, close to the natural location of the ovaries, or the tissue can be put under the skin of the abdomen. After you have had the transplant, your hormone function will be tested every month. Each month, you will have a blood draw to measure hormones and an ultrasound to see how the tissue is growing. These monthly visits will continue until you have normal hormone levels. If the transplant is successful, it is expected that your hormones would return to normal in 3 - 7 months. If your hormone levels return and stay regular for three months, then Dr. Kim will talk to you about trying to get pregnant. The method of getting pregnant will depend on the type of transplantation surgery you had and your current medical condition. You will have weekly blood tests and other tests to determine the best way to get pregnant.
16198894|NCT01403649|Behavioral|Private/public collaboration to increase flu vaccination|Intervention practices will develop office-based interventions including methods to identify high-risk patients within their practices and methods of maximizing the immunization of these children within the practice, use of patient reminders, after-hours influenza clinics, walk-in provision of influenza vaccine and increased focus on education regarding the need for immunization. The practices will also collaborate with their county public health departments and visiting nursing associations to develop private-public collaborative interventions that may include large clinics for school-aged children for multiple practices and tracking of influenza supplies and redistribution of influenza vaccine between practices when supplies are delayed or inadequate.
16198895|NCT01403649|Other|Usual care|This group will continue administering influenza vaccine to their patients in their practice as they normally do.
16198896|NCT01403636|Drug|SAR245409|Pharmaceutical form:capsule Route of administration: oral
16198897|NCT01403623|Procedure|Resuscitation and post resuscitation care with plastic bag|Infant will be resuscitated and placed in a plastic bag up to his/her neck and around the back of his head (not covering the face) in the delivery room and taken to the nursery. The infant will remain in the plastic bag until first axillary temperature remains stable at 36.5-37.5 degrees Celsius. Expected length of time approximately one hour.
16198898|NCT01403623|Procedure|Resuscitation- no plastic bag for temperature regulation|Infant will be resuscitated in the delivery room and taken to the nursery. The infant will be observed per unit standard until first axillary temperature remains stable at 36.5-37.5 degrees Celsius. Expected length of time approximately one hour.
16198899|NCT01403610|Drug|TH-302 preoperative|TH-302 single dose at 575 mg/m2 administered preoperatively, followed by postoperative combination therapy bevacizumab at 10mg/kg every 2 weeks and TH-302 at 240 - 480 mg/m2 every 2 weeks (4 week cycle) until disease progression. Subjects will be randomized (2:1) to receive pre-operative dose of TH-302.
16198900|NCT01403610|Drug|Placebo|Placebo administered preoperatively, followed by postoperative combination therapy bevacizumab at 10mg/kg every 2 weeks and TH-302 at 240 - 480 mg/m2 every 2 weeks (4 week cycle) until disease progression. Subjects will be randomized (2:1) to receive pre-operative dose of TH-302.
16198901|NCT01403610|Drug|TH-302 (escalating) with bevacizumab 10mg/kg|Combination of 10mg/m2 of bevacizumab with an escalating dose of TH-302 from 240 to 670 mg/m2
16198902|NCT01403597|Device|Refirme ST Applicator and Matrix RF Applicator|5 treatments with combination of devices every 4 weeks to the facial (or sub facial regions).
16198903|NCT01403584|Device|AutoVPAP with addition of AutoEPAP|Implementation of automated algorithm for adjustment of conventional device parameter (EPAP0.
16198904|NCT01403584|Device|AutoVPAP with EPAP manually selected|Conventionally applied Expiratory Positive Airway Pressure (EPAP)
16198905|NCT01403571|Dietary Supplement|Salba (Salvia hispanica L.)|30g/1000kcal/day over 24 wks
16198906|NCT01403571|Dietary Supplement|Oat-based Control|Placebo: 36g/1000kcal/day over 24 weeks
16198907|NCT01403558|Behavioral|Cognitive behavioral therapy|Cognitive behavioral therapy
16198908|NCT01403545|Drug|Liposomal Curcumin|Single dose intravenous infusion of liposomal Curcumin at 10, 20, 40, 80, 120, 180 mg/m² over 120 minutes
16198909|NCT01403545|Other|Placebo|5% glucose infusion over 120 minutes
16198910|NCT01403532|Drug|Traditional intervention for HH using HCG and FSH|Human chorionic gonadotropin(HCG),2000U,im,2 times/week, one year and a half; Follicle stimulating hormone(FSH),75U, im, 3 times/week, one year;
16198911|NCT01403532|Drug|Sequential intervention for HH using HCG and FSH|Human chorionic gonadotropin,2000U,im, 2 times/week, one and half a year Follicle stimulating hormone,75U,im,3 times/week, every other three months
16198912|NCT01403532|Drug|Sequential intervention for HH using HCG and FSH plus zinc|Human chorionic gonadotropin,2000U,im,2 times/week, one year and a half Follicle stimulating hormone,75U, im, 3 times/week, every other three months Zinc gluconate 20mg,P.O, twice daily
16198913|NCT01403506|Drug|N-acetyl Cysteine|600 mg N-acetyl Cysteine 6 hrs before renal transplantation, and 12 hrs and 18 hrs after renal transplantation.
16198914|NCT01403493|Behavioral|Patient education|
16198915|NCT01403467|Device|Continuous positive airway pressure|CPAP 8 cmH2O
16198916|NCT01403454|Behavioral|Interactive Health Communication Application|web-based application
16198917|NCT01403441|Device|Radiosurgical Neuromodulation using the Cyberknife|our team has selected 60 Gray (Gy) as the dose to the target margin to be used for radiosurgical neuromodulation in patients with intractable bipolar disorder; the target being the anterior cingulate (Cg) that correlates with Brodmann area 25 (Cg25).
16198918|NCT01403428|Other|Noninvasive positive pressure ventilation|Noninvasive positive pressure ventilation (NPPV) will deliver pressurized gas through a nasal or oronasal mask, connected to a pressure targeted ventilator. NPPV provides ventilator support without the use of an endotracheal tube. Standard of care includes use of corticosteroids, oxygen, short acting β-agonist and inhaled ipratropium bromide.
16198919|NCT01403415|Drug|Dexamethasone|Given PO or IV
16198920|NCT01403415|Other|Laboratory Biomarker Analysis|Correlative studies
16198921|NCT01403415|Drug|Methotrexate|Given IT
16198922|NCT01403415|Drug|Mitoxantrone Hydrochloride|Given IV
16198923|NCT01403415|Drug|Pegaspargase|Given IV
16198924|NCT01403415|Other|Pharmacological Study|Correlative studies
16198925|NCT01403415|Drug|Temsirolimus|Given IV
16198926|NCT01403415|Drug|Vincristine Sulfate|Given IV
16198927|NCT01403389|Drug|Eculizumab|1200 milligrams Eculizumab diluted in 0.9% NaCl to 5mg/mL for a total volume of 240 mL administered by IV infusion over 35 minutes in the operating room prior to organ reperfusion
16198928|NCT01403389|Drug|Placebo|240 mL of 0.9% Sodium Chloride IV fluid given as placebo in the operating room prior to organ reperfusion
16198929|NCT01403376|Drug|teriflunomide|"Film-coated tablet
~Oral administration"
16198930|NCT01403376|Drug|Interferon-β-1|Powder for reconstitution, of any licensed strength for either intramuscular or subcutaneous injection
16198931|NCT01403376|Biological|Influenza vaccine|"Inactivated, split-virion influenza vaccine 2011-2012
~One administration by intramuscular or intradermal route as per product specification"
16198965|NCT01403103|Other|enzyme-linked immunosorbent assay|Correlative studies
16198966|NCT01403103|Other|laboratory biomarker analysis|Correlative studies
16198967|NCT01403103|Genetic|reverse transcriptase-polymerase chain reaction|Correlative studies
16198932|NCT01403363|Drug|use of fentanyl patch that was halved|A sample of 95 patients will be recruited. Once consent form is signed, blood samples will be collected twice: 1. At the time of the visit; 2. After 144 hours (about 6 days) from the first sample, and at least 36 hours after replacing the cut patch. Pain management will be evaluated at both visits using the Brief Pain Inventory (Hebrew version) - BPI questionnaire, and rescue doses used before and after the cutting of the patch. The blood samples will be transferred to the laboratory for testing of fentanyl concentration levels.
16198933|NCT01403350|Device|Malaria Rapid Diagnostic test|Study Phase I: RDT used under the standard programme of training and support; Study Phase II: RDTs deployed with additional programme components including improved training and supportive interventions
16198934|NCT01403337|Other|Ischemic preconditioning|The RIPC protocol will consist of three cycles of the following: 5-minute inflation of a blood pressure cuff around the right upper arm to 200 mmHg (or 20 above the systolic blood pressure if baseline BP > 200 mmHg) to allow for external compression of the brachial artery resulting in transient arm ischemia, followed by a 5-minute interval of cuff deflation to allow for reperfusion. The total duration of the protocol is 30 minutes equally divided between ischemia and reperfusion. The protocol is to be applied in the patient room the morning of the operation.
16198935|NCT01403337|Other|Control|A Blood Pressure cuff inflated to 40-50 mmHg
16198936|NCT01403324|Drug|TSH stimulation|rh TSH stimulation followed by thyroid hormon withdrawal
16198937|NCT01403311|Drug|5-Aminolevuline Acid|5-Aminolevuline Acid (ALA) at 30 mg/kg given orally 4 hours before surgery
16198938|NCT01403298|Behavioral|Family-Based HIV prevention|This individual, family-based intervention provides sex and HIV/AIDS education as part of a family-based general health education program that focuses on safe decision-making and how to control emotions to stay safe and improve parenting skills.
16198939|NCT01403298|Other|Adolescent Only Health Promotion|An individual, adolescent-only health education program that focuses on risk behaviors related to HIV/AIDS, smoking, diet and exercise
16198940|NCT01403285|Drug|Cyclophosphamide|One single low-dose i.v. infusion of cyclophosphamide (300mg/m2) prior to the first vaccination as pre-treatment
16198941|NCT01403285|Biological|IMA950 plus GM-CSF|Six vaccinations with IMA950 plus GM-CSF as adjuvant on 8 pre-defined days from Day 1 to Day 78
16198942|NCT01403285|Biological|IMA950|After Day 78, vaccinations with IMA950 (no GM-CSF) will be given on a monthly basis for up to one year from start of vaccination or until disease progression
16198943|NCT01403285|Drug|Imiquimod|Imiquimod will be topically applied 10-20 minutes after each vaccination. After the third vaccination onward patients will apply additional imiquimod 24 hours after each vaccination at home on their own
16198944|NCT01403272|Device|DermaTherapy® Linen and underpads.|"DermaTherapy® Linen is a 100% synthetic silk-like fabric technology designed to provide a cleaner, drier and smoother surface between the skin and support systems for a healthy micro-climate.
~Subjects in the DermaTherapy® Linen Group are compared to subjects receiving usual care - bed linen made of cotton-blend fabrics."
16198945|NCT01403259|Drug|S-1 plus oxaliplatin|S-1 60 mg BID at day 1-14 Oxaliplatin 100 mg/m2 at day 1 Frequence of cycles: every 3 weeks
16198946|NCT01403246|Drug|Lenalidomide; Chlorambucil|MTD of lenalidomide given in combination with chlorambucil
16198947|NCT01403233|Dietary Supplement|cogniVida 50mg/day|2 capsules 25 mg (total 50 mg) cogniVida™ once a day
16198948|NCT01403233|Dietary Supplement|cogniVida100mg/day|4 capsules 25 mg (total 100 mg) cogniVida™ once a day
16198949|NCT01403233|Dietary Supplement|Rebaudioside-A 303.7mg/day|4 capsules 75.92 mg (total 303.68 mg) rebaudioside A once a day
16198950|NCT01403220|Procedure|Hemodiafiltration first|Patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemodiafiltration.
16198951|NCT01403220|Procedure|Hemofiltration first|Patients will alternate consecutive dialysis sequences between hemodiafiltration and hemofiltration, but starting with hemofiltration.
16198952|NCT01403207|Other|musculoskeletal|Many musculoskeletal conditions are impacted by the chromosomal sex of the patient. While osteoarthritis (OA) is predominant in men younger than 50 years of age, after age 50 the condition is more prevalent in women, particularly post-menopause. This has implications for diagnosis and treatment of OA, as well as for joint replacement.
16198953|NCT01403194|Device|CPAP/BiPAP|Subjects will be treated with either CPAP or Bi-PAP for three months.
16198954|NCT01403181|Drug|Boceprevir|"In the experimental arm boceprevir (800 mg orally three times daily), PEG-IFN and ribavirin will be given for 24 weeks after the lead-in; the patients who will have undetectable HCV-RNA at week 8 will stop treatment at week 28; those who will be HCV-RNA positive at any visit between week 8 and 24 will receive an additional 20 weeks of PEG + RBV. Treatment will be discontinued if HCV-RNA is positive at week 24.
~Immunological analysis will be performed longitudinally at the following time points: week -4, 0, 4 (end of lead-in), 8, 12, 24, 48, week 24 of follow-up. HCV-RNA will be quantified at the same time points and viremia will be correlated with immunological data."
16198955|NCT01403168|Other|OSTEOPATHY + conventional analgesic treatments|"5 sessions for osteopathy are planned and will start in the 15 days following the enrollment.
~The conventional analgesic treatments will be administered in the 15 days following the enrollment."
16198956|NCT01403168|Other|Conventional analgesic treatments|These treatments will be administered in the 15 days following the enrollment. Dose and frequence will depend on patients.
16198957|NCT01403155|Biological|INO-3401 + EP|All subjects will receive 0.9mg/mL of study vaccine (INO-3401 DNA plasmid vaccine)at Day 0 and Month 3.
16198958|NCT01403129|Procedure|Artemis Ultrasound Exam|Ultrasound exam of both eyes using an Artemis-2 device. Exam will be performed once. Exam duration is 20 minutes per eye.
16198959|NCT01403129|Procedure|Optical Coherence Tomography (OCT) Exam|OCT exam of both eyes. Exam will be performed once, duration is 10. I utes per eye.
16198960|NCT01403116|Drug|Oral testosterone undecanoate|Starting dose: 200 mg T (as TU) BID. Doses may be titrated up to a maximum dose of 300 mg T (as TU) BID or down to a minimum dose of 100 mg T (as TU) BID based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.
16198961|NCT01403116|Drug|topical testosterone gel|Starting dose: 5 g T applied once daily. Doses may be titrated up to a maximum dose of 10 g daily or down to a minimum dose of 2.5 g daily based on serum T values collected at 4-6 hours post AM dose on Days 30 and 60.
16198962|NCT01403103|Dietary Supplement|cholecalciferol|Given PO
16198963|NCT01403103|Procedure|biopsy|Correlative studies
16198968|NCT01403090|Device|Angel Catheter|The Angel Catheter will be inserted in the femoral vein following standard central line placement techniques. Once the catheter is on the Inferior Vena Cava, the filter will be deployed following the manufacturer instructions and secured to the skin.
16198969|NCT01403077|Device|480 Biomedical Bioresorbable Scaffold System|480 Biomedical Bioresorbable Scaffold System
16198970|NCT01403064|Biological|ALD518|IV
16198971|NCT01403064|Drug|0.9% saline|IV Infusion
16198972|NCT01403051|Drug|EFV/FTC/TDF|FDC efavirenz/emtricitabine/tenofovir disoproxil fumarate (Atripla) 600 mg/200 mg/ 300 mg tablet taken orally once daily at bedtime on an empty stomach.
16198973|NCT01403051|Drug|Calcium Carbonate|Calcium carbonate 500 mg tablet taken orally twice daily with food for 48 weeks.
16198974|NCT01403051|Drug|Vitamin D3|One Vitamin D3 4000 IU capsule taken orally once daily with food for 48 weeks.
16198975|NCT01403051|Drug|Placebo for calcium carbonate|A placebo for calcium carbonate twice daily taken orally as one x 0 mg tablets with food for 48 weeks
16198976|NCT01403051|Drug|Placebo for vitamin D3|A placebo for vitamin D3 once daily taken orally as one capsule with food for 48 weeks.
16198977|NCT01403038|Drug|Elagolix|Elagolix Dose Regimen 1 for 84 days
16198978|NCT01403038|Drug|Elagolix|Elagolix Dose Regimen 2 for 84 days
16198979|NCT01403038|Drug|Elagolix|Elagolix Dose Regimen 3 for 84 days
16198980|NCT01403038|Drug|Elagolix|Elagolix Dose Regimen 4 for 84 days Other interventions may be added
16198981|NCT01403038|Drug|Elagolix|Elagolix Dose Regimen 5 for 84 days
16198982|NCT01403038|Drug|Elagolix|Elagolix Dose Regimen 6 for 84 days
16198983|NCT01403038|Drug|elagolix|Elagolix plus Activella Dose Regimen 7 for 84 days
16198984|NCT01403025|Drug|liraglutide|Once daily at a fixed timing, and subcutaneously (under the skin) in the abdomen, in the thigh or in the upper arm
16198985|NCT01403012|Other|Withdrawal of venous blood samples|"Withdrawal of venous blood samples (approx. 20 ml) and 2 skin biopsies (5 mm)
~Laboratory measurements:
~Fasting serum concentrations of 200 metabolites covering a biologically relevant panel of amino acids, sugars, acylcarnitines and phospholipids Genome-wide expression profiles generated from RNA derived from peripheral leukocytes"
16198986|NCT01402999|Device|easypod™|Saizen (Somatotropin) as per Summary of Product Characteristics (SmPC) administered by easypod™
16198987|NCT01402986|Other|Placebo Q2W|Participants who received matching placebo subcutaneous injection every 2 weeks (Q2W) for a total of 26 doses up to 50 weeks.
16198988|NCT01402986|Biological|Tralokinumab 300 mg, Q2W|Participants received tralokinumab 300 mg subcutaneous injection Q2W for a total of 26 doses up to 50 weeks.
16198989|NCT01402986|Other|Placebo, Q2/4W|Participants received matching placebo subcutaneous injection Q2W for 12 weeks followed by Q4W for 38 weeks (Q2/4W) for a total of 16 doses.
16198990|NCT01402986|Biological|Tralokinumab 300 mg, Q2/4W|Participants received tralokinumab 300 mg subcutaneous injection Q2W for 12 weeks followed by Q4W for 38 weeks (Q2/4W) for a total of 16 doses.
16198991|NCT01402973|Other|Dietary|The diets will each consist of 3 meals/day and 1 snack/day which are either high or low in AGEs.
16198992|NCT01402960|Device|High Definition Transcranial Direct Current Stimulation (HD-tDCS)|"Subject will receive active anodal/cathodal and sham HD-tDCS in a randomized, counterbalanced order. Each stimulation session will be separated by at least one week to avoid carryover effects. For both active and sham HD-tDCS the electrodes will be placed over the primary motor cortex, at an intensity of 2mA.
~For active anodal stimulation, the anode will be over the primary motor cortex, and the cathodal electrodes (4) will surround the anode in a 3 inch square, duration will be 20 minutes.
~For active cathodal stimulation, the cathode will be over the primary motor cortex, and the anodal electrodes (4) will surround the cathode in a 3 inch square, duration will be 20 minutes.
~For sham stimulation, the same procedure will be used, however, current will only be active for 30 seconds (current ramping up, then ramping down)"
16198993|NCT01402947|Drug|Ciprofloxacin XR + MMX Placebo|MMX Mesalazine/mesalamine placebo dosed once-a-day (QD) orally for 3 days, then a single oral 500 mg dose of ciprofloxacin XR + a single oral dose of MMX Mesalazine/mesalamine placebo on day 4
16198994|NCT01402947|Drug|MMX Mesalazine/mesalamine + Ciprofloxacin XR|MMX Mesalazine/mesalamine 4.8 g QD orally for 3 days, then a single oral 500 mg dose of ciprofloxacin XR + a single oral dose 4.8 g of MMX Mesalazine/mesalamine on day 4
16198995|NCT01402934|Procedure|Hydroxyethyl starch solution (Voluven) infusion|fluid loading will be performed by hydroxyethyl starch solution (Voluven), at 6 mL/kg
16198996|NCT01402921|Device|V0322 BC|"Stocking Elastic MCT is a widely recognized and the consensus-approved treatment for chronic venous insufficiency (CVI).Efficacy evidence level is often insufficient (grade B or C), or based on studies carried prior to CEAP classification (2004).
~The medical device is defined by the following parameters: ankle pressure(10 mmHg)and calf pressure (23 mmHg)
~3 months duration daily treatment"
16198997|NCT01402908|Drug|PI-88|Lyophilized powder reconstituted to provide 160 mg of PI-88
16198998|NCT01402908|Other|Placebo|Lactose lyophilized powder
16198999|NCT01402895|Other|Exercise|Transversus abdominus exercise
16199000|NCT01402895|Other|Mobilizations|The physiotherapist will perform mobilizations to the L-spine and SI joints with the participant in a specific position.
16199001|NCT01402882|Drug|Tranexamic Acid|2 grams (1 gram over 10 minutes and 1 gram over 8 hours)
16199002|NCT01402869|Drug|4% prilocaine plain|5mg/kg via infiltration into multiple sites of the buccal mucosa of mouth 1 time prior to start of restorative dental treatment
16199003|NCT01402869|Drug|2% Lidocaine with 1:100,000 epinephrine|2.5mg/kg via infiltration into multiple sites of buccal mucosa of mouth 1 time prior to restorative dental treatment
16199004|NCT01402856|Other|Education|An educational program targeting HS students on the risks of distracted driving that was 60-min long & utilized: a 5-10 min DVD on a teenager's real-life experience of the devastating effects of distracted driving, other videos placing the viewer in the driver's seat, power point presentations of state and national statistics related to seat belt usage, mortality, and substance use, overview of state laws, demonstrations of the physics of an accident, & interactive games simulating distracted driving.
16199005|NCT01402843|Drug|pitavastatin, valsartan, placebo|pitavastatin 4mg/day 8 week valsartan 320mg/day 8 week
16199006|NCT01402830|Other|Visual analogue scales (EVAs)|This scale measures the pain intensity.
16200532|NCT01390571|Other|pharmacological study|
16199007|NCT01402817|Drug|Sutent®/Sunitinib|Upon enrollment, subjects will receive Sutent® orally. Adults (Age >18) will receive 25mg. Children will receive 10mg/m2/day. All subjects will take the daily dose for 28 days followed by a 14 day rest period. If subjects tolerate the initial dose, adults will be increased to 37.5mg and children will be increased to 15mg/m2/day. Again, subjects will take that dose for 28 days followed by a rest period of 14 days. Adults who tolerate the increase will go up to the maximum dose of 50mg. The maximum dose for children is 15mg/m2/day.
16199008|NCT01402791|Other|Questionnaires|All included couples (women and their partners) are required to fill out several questionnaires: 1. Questionnaire for women; 2. Self-questionnaire for women; 3. SFQ for women; 4. Questionnaire for men; 5. Self-questionnaire for men; 6. IIEF for men.
16199009|NCT01402765|Device|Summit first|Pressure measurements are first taken on the Summit mattress. The patient is then transferred to a Nimbus 3 mattress, and the measures are repeated.
16199010|NCT01402765|Device|Nimbus 3 first|Pressure measurements are first taken on the Nimbus 3 mattress. The patient is then transferred to a Summit mattress, and the measures are repeated.
16199011|NCT01402752|Biological|Blood flow to the tracheo-bronchial mucosa|Measurement of blood flow to the tracheo-bronchial mucosa via differential absorption of diluted dimethyl ether tracer gas.
16199012|NCT01402739|Other|Point of Care Coagulation Monitoring Guided Transfusion Algorithm|(thromboelastometry, aggregometry, blood gas analysis)
16199013|NCT01402739|Other|standard coagulation monitoring guided transfusion algorithm|aPTT, ACT, platelet count, hemoglobin, fibrinogen
16199014|NCT01402726|Procedure|renal sympathetic modification|Device: THERMOCOOL® Catheter Renal sympathetic modification with a catheter-based procedure
16199015|NCT01402713|Biological|GC1107|GC1107-T5.0: low dose, GC1107-T7.5: high dose
16199016|NCT01402713|Biological|TD_PUR INJ / SK Td vaccine|step 1(phase 2)-TD_PUR INJ step 2(phase 3)-SK Td vaccine
16199017|NCT01402700|Device|Visi-Pro™ Balloon Expandable Stent System|Implantation of one or more study devices in the common and/or external iliac artery.
16199018|NCT01402674|Drug|Abrupt cessation of phentermine pharmacotherapy|Patients will be asked to cease taking phentermine, then to complete psychometric scales 24 and 48 hours later. Patients will be examined at 48 hours by physician who will determine if phentermine should be continued or discontinued.
16199019|NCT01402648|Dietary Supplement|Eviendep (CM&D Pharma Limited, UK)|175 mg milk thistle (fruit dry extract, 70% in silymarin)+ 20 mg flaxseed (dry extract, 40% in secoisolariciresinoldiglucoside)+750 mg non-starch, insoluble and indigestible fiber (6% in lignin). Provided in 5 g sachets, to be dissolved in half glass water, administered twice a day for 60 days on top of the common diet.
16199020|NCT01402648|Dietary Supplement|Maltodextrins|900 mg maltodextrin+excipient as per the active comparator eviendep, up to 5 g/sachet
16199021|NCT01402635|Device|point-of-care chemistry test(POCT) (Piccolo)|comprehensive chemistry POCT including ALB, ALP, ALT, AST, BUN, Ca, Cl-, Cre, Glu, K+, Na+, TBil, TCO2, TP It takes 12minutes to perform analyze.
16199022|NCT01402622|Drug|Propofol anesthesia|In the TIVA and TIVA-P group, propofol and remifentanil were used for induction and maintenance of anaesthesia. In the control group, propofol and remifentanil were used for induction and anaesthesia was maintained with desflurane and remifentanil. In the control and TIVA-P group, ramosetron 0.3mg was administered at the end of surgery. In all patients, postoperative pain was controlled with fentanyl-based intravenous patient-controlled analgesia. he depth of anaesthesia was monitored with a bispectral index score monitor and maintained at 40-60.
16199023|NCT01402609|Device|electronic discharge communication tool|The intervention will consist of discharges being conducted with the use of the electronic discharge communication tool.For the intervention group, the care team will record the information that they collect directly into the computerized tool during the hospital stay.
16199024|NCT01402609|Device|Usual care|Control group will receive usual care. This usual care typically involves paper-based handwritten discharge communications, with subsequent provision of a dictated discharge summary produced some time after hospital discharge, with unpredictable success of delivery, and with unstructured and sometimes haphazard content.
16199025|NCT01402596|Drug|Midazolam|0,4 mg per kg - intranasal midazolam - once
16199026|NCT01402596|Drug|Chloral Hydrate|50 mg per kg, rectal
16199027|NCT01402583|Drug|PEG IFN/Ribavirin|PEG IFN/Ribavirin
16199028|NCT01402570|Dietary Supplement|Glutathione|glutathione is a dietary supplement and an antioxidant. Subjects will take 1000 mg per day for three month. Each capsule contains 500 mg glutathione.
16199029|NCT01402557|Behavioral|Weight Loss Church Program|An initial 12-week weight loss program held in churches to ensure adequate participation, competence in performing exercises, and development of social relationships among participants. All participants attend the church programs prior to the weight maintenance phase.
16199030|NCT01402557|Behavioral|Telephone Counseling|Following completion of the weight loss program, participants will receive monthly telephone counseling.
16199031|NCT01402557|Behavioral|Telehealth Support|After the weight loss program, women will access the home weight maintenance telehealth program through Internet enabled digital video recorders connected to their television sets. The telehealth program includes three components: (1) Weekly Video: home access to weekly video programs including problem solving and relapse prevention strategies, as well as motivational stories; (2) Teleexercise: home access to updated video exercise programs; and (3) Electronic Communication: social support through online communication with other participants, and with an exercise and nutrition interventionist.
16199032|NCT01402544|Drug|ranibizumab|0.5mg intravitreal injection, monthly for 12 months, or until BCVA returns to pre-wet AMD baseline.
16199033|NCT01402531|Drug|Submucosal Bevacizumab|200 mg Bevacizumab, injected submucosally- 100 mg per nostril
16199034|NCT01402518|Procedure|Per-oral enodscopic myotomy|
16199035|NCT01402505|Procedure|Transvaginal NOTES sleeve gastrectomy|transvaginal NOTES sleeve gastrectomy
16199215|NCT01401075|Drug|doxifluridine|600 - 900 mg per day orally, depending on weight and status of the patient
16199038|NCT01402479|Drug|Ramipril|ramipril 2.5mg twice a day
16199039|NCT01402466|Behavioral|Standard Referral|Participants randomized to this arm will be referred to local HIV care resources
16199040|NCT01402466|Behavioral|Project Bridge|Arm 2
16199041|NCT01402453|Behavioral|Monetary Incentives|Subjects will receive a payment of $2 per mm. drop in BP from the baseline value at each follow-up visit. If a subject reaches their target BP, they will receive a minimum of $30 each time to motivate continued participation in the study and reinforce continued improvement relative to baseline BP. Lottery incentives will be added to motivate attainment of intermediate goals. For remembering to do certain actions that assist in the management of their BP, the subject will receive one entry into a lottery with an expected value of $3 per ticket. For the lottery payment, the subject will be given 3 chances to randomly select a card that may or may not show a winning monetary prize.
16199042|NCT01402453|Behavioral|Intrinsic Motivation|A)Subjects will complete an additional component to the baseline questionnaire that probes systematically for areas of experience that currently are of importance to them. Their answers will help to identify patients' intrinsic motivations for controlling their BP. B)Answers to this component will be analyzed to characterize a role self-identity that will be used by study personnel to frame their interactions with the subject for the remainder of the study. C) Role identity will be kept highly salient throughout the study by using identity primes that remind the individual that improving blood pressure levels is an important responsibility associated with that role.
16199043|NCT01402440|Drug|AEB071|
16199044|NCT01402427|Drug|Verapamil|Intraarterial administration of 5 mg verapamil diluted with saline to 10 mL.
16199045|NCT01402427|Drug|Placebo|Intraarterial administration of 10 mL saline.
16199046|NCT01402414|Radiation|NB-UVB|The SB-UVB irradiations (Cosmedico, Villingen-Schwenningen) are adapted to the SB-MED-UVB (70%) started and increased by 10-20% per session. The UV irradiations are carried out four times a week over a period of 4 weeks.
16199047|NCT01402414|Radiation|Bath-PUVA|Bath PUVA is performed with 8-Methoxypsoralen baths (concentration of ultimately 0.5 mg / l ) at 37 ° C with a bath time of 20 minutes and subsequent UVA irradiation (Waldmann cabine, 320-400 nm). The first dose is 70% of MPD, followed by 20% increase. The latter takes place at the earliest after 72 hours. The UV irradiations are carried out four times a week over a period of 4 weeks.
16199048|NCT01402414|Radiation|NB-UVB plus salt water baths|First, a 20-minute bath in 3% salt water (Dead Sea salt, 37 ° C) is taken. Thereafter, a NB-UVB irradiation is performed. The UV radiation can be administered according to established protocols. The NB-UVB irradiations (Cosmedico, Villingen-Schwenningen) are adapted to the NB-MED-UVB (70%) started and increased by 10-20% per session. The UV irradiations are carried out four times a week over a period of 4 weeks.
16199049|NCT01402401|Drug|AUY922|
16199050|NCT01402401|Drug|Trastuzumab|
16199051|NCT01402388|Behavioral|Group lifestyle programme|
16199052|NCT01402375|Drug|Hydrocodone (first trial)|Patients will take 1 dose of Hydrocodone 5mg / Acetaminophen 500mg every 4 hours as needed for pain
16199053|NCT01402375|Drug|Codeine (first trial)|Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain
16199054|NCT01402375|Drug|Oxycodone (for second trial)|Patients will take 1 dose of Oxycodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain
16199055|NCT01402375|Drug|Codeine (for second trial)|Patients will take 1 dose of Codeine 30 mg / Acetaminophen 300 mg every 4 hours as needed for pain
16199056|NCT01402375|Drug|Oxycodone (third trial)|Patients will take 1 dose of Oxycodone 5mg / Acetaminophen 325 mg every 4 hours as needed for pain
16199057|NCT01402375|Drug|Hydrocodone (third trial)|Patients will take 1 dose of Hydrocodone 5 mg / Acetaminophen 325 mg every 4 hours as needed for pain.
16199058|NCT01402336|Drug|GnRH antagonist (Cetrorelix)|In the first arm, cetrotide will be administrated from the first day during stimulation. In the second arm, cetrotide will be administrated from the sixth day during stimulation
16199059|NCT01402336|Drug|Conventional GnRH agonist (Triptorelin)|Patients in the agonist group were administered GnRH agonist started 5 days before discontinuation of the oral contraceptive.
16199060|NCT01402323|Other|time point of tooth extraction|
16199061|NCT01402310|Other|Ultrasound and digital cervical examination|Cervical length by transvaginal ultrasound Bishop score by digital examination Take cervicovaginal samples
16199062|NCT01402297|Drug|Apocynin and placebo nebulization|6 ml of apocynin of total dose 3 mg (0.5 mg/ml dissolved in sterile 0.9% NaCl as the study drug) and 0,9% NaCl as placebo, has been nebulized for 15-20 min through the mouthpiece with using of a nose clip. A nebulizer Pulmo Aide AP-50 (DeVilbiss; Richmond, VA) was used (mass median aerosol diameter 3.1 mm, output 0.3 ml/min.)
16199063|NCT01402284|Drug|Carfilzomib|Cycle 1: 20 mg/m(2) intravenous (IV) infusion over 30 minutes on days 1 and 2, then 36 mg/m(2) IV on days 8, 9, 15, and 16 Cycle 2-8: 36mg/ m(2) IV infusion over 30 minutes on days 1, 2, 8, 9, 15, and 16
16199064|NCT01402284|Drug|Lenalidomide|Cycle 1: 25 mg oral days 2-21 of 28-day cycle; Cycle 2 - 8: 25 mg oral days 1-21 of 28-day cycle; After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles; After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year
16199065|NCT01402284|Drug|Dexamethasone|Cycle 1: 20 mg oral or IV on days 2, 8, 9, 15, 16, 22, and 23 Cycle 2-4: 20 mg oral or IV on days 1, 2, 8, 9, 15, 16, 22, and 23 Cycle 5-8: 10 mg oral or IV on days 1, 2, 8, 9, 15, 16, 22, and 23
16199066|NCT01402284|Drug|Lenalidomide|After 8 cycles of combination carfilzomib, lenalidomide, and dexamethasone (CRd), patients may continue Lenalidomide for 12 cycles
16199067|NCT01402284|Drug|Lenalidomide|After 12 cycles of extended dosing of Lenalidomide, patients may continue Lenalidomide for one year
16199068|NCT01402271|Drug|carboplatin|
16199069|NCT01402271|Drug|paclitaxel|
16199070|NCT01402271|Drug|pazopanib hydrochloride|
16199071|NCT01402271|Other|laboratory biomarker analysis|
16199072|NCT01402271|Other|pharmacological study|
16199073|NCT01402258|Behavioral|Tailored Internet-administrated CBT-Treatment|This intervention contains 6-8 text-based self-help modules in which 4 modules are fixed (the first three and the last) and the rest are prescribed following the diagnostic telephone interview. These modules contain material on panic disorder, social phobia, stress management, assertiveness training, concentration, relaxation among other things.
16199074|NCT01402245|Biological|Pneumococcal polysaccharide vaccine|Pneumococcal polysaccharide vaccine 0.5 ml i.m.
16199075|NCT01402245|Biological|pneumococcal conjugate vaccine|pneumococcal conjugate vaccine 0.5 ml i.m.
16199076|NCT01402219|Drug|Iopamidol injection 76%|Iopamiro-370 (Iopamidol injection 76%) is provided in single dose bottles/vials, ready to use, aqueous, nonpyrogenic, colorless to pale yellow sterile solution
16199077|NCT01402219|Drug|iodixanol|Visipaque 320 (iodixanol) injection is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to pale yellow solution
16199078|NCT01402206|Behavioral|Structured patient-centered follow up of depression|"All patients who agree to participate in the study are diagnosed by their GP with a diagnostic assessment instrument called PRIME-MD. Participants in the intervention group visit their GPs at baseline and 4, 8, and 12 weeks. At each visit, participants complete MADRS-s for the assessment of depression severity and discuss the results with their GP in a patient-centered consultation. We have chosen to use the MADRS/MADRS-S depression rating scale in this study because it is a easy to use standard instrument especially suitable for measuring change in depressive symptoms.
~The control group receives treatment as usual (no intervention)."
16199079|NCT01402193|Drug|Pre-radiotherapy commencement of Arimidex|Arimidex:1mg P.O. daily will be prescribed for 8 weeks in post-mastectomy patients and 9 weeks in BCT patients within the study period. Arimidex starts 3 weeks before adjuvant radiotherapy and throughout the course of radiotherapy.Total duration of adjuvant hormonotherapy is prescribed by the investigators at the completion of study, 5 years in principle.
16199080|NCT01402193|Drug|Post radiotherapy commencement of Arimidex|Arimidex：1mg P.O. daily will be prescribed at 2 weeks after the end of radiotherapy.Total duration of adjuvant hormonotherapy is prescribed by the investigators at the completion of study, 5 years in principle.
16199081|NCT01402193|Radiation|Radiotherapy|Radiotherapy is delivered to the whole breast/chest wall +/- regional lymph nodes to a total dose of 50Gy/25 fractions/5weeks, an additional tumor bed boost of 10Gy/5 fractions/1week is delivered to patients with breast conservative surgery
16199082|NCT01402193|Radiation|Radiotherapy|Radiotherapy is delivered to the whole breast/chest wall +/- regional lymph nodes to a total dose of 50Gy/25 fractions/5weeks, an additional tumor bed boost of 10Gy/5 fractions/1week is delivered to patients with breast conservative surgery
16199083|NCT01402180|Biological|Nimotuzumab|
16199084|NCT01402180|Radiation|Radiation therapy|
16199085|NCT01402180|Radiation|radiation therapy|
16199086|NCT01402180|Drug|chemotherapy|
16199087|NCT01402180|Drug|chemotherapy|
16199088|NCT01402167|Procedure|Kyphoplasty|Patients will be treated via a balloon kyphoplasty surgical procedure
16199089|NCT01402167|Procedure|Vertebroplasty|Patients will be treated via a transcutaneous vertebroplasty procedure.
16199090|NCT01402154|Biological|EPISPOT detection of the number of circulating cells|EPISPOT detection of the number of circulating, functional, prostate cells per unit blood
16199091|NCT01402154|Biological|CellSearch detection of the number of circulating, functional, prostate cells|CellSearch detection of the number of circulating, functional, prostate cells per unit blood
16199092|NCT01402141|Dietary Supplement|Chungkookjang|Chungkookjang(35g/say)for 12 weeks
16199093|NCT01402141|Dietary Supplement|Placebo|Placebo(35g/day) for 12 weeks
16199094|NCT01402128|Dietary Supplement|Barley beta-glucan(3.0g)|Barley beta-glucan(3.0g/day) for 12 weeks
16199095|NCT01402128|Dietary Supplement|Placebo|Placebo for 12 weeks
16199096|NCT01402115|Dietary Supplement|Polycan|polycan 150 mg/d for 12 weeks
16199097|NCT01402115|Dietary Supplement|Placebo|Placebo 150mg/d for 12 weeks
16199098|NCT01402102|Dietary Supplement|Aged garlic powder|Aged garlic powder(6.0g/day)
16199099|NCT01402102|Dietary Supplement|Placebo powder|Placebo powder(6.0g/day)
16199100|NCT01402089|Drug|Sunitinib|Patients with renal-cell cancer or GIST are receiving conventional treatment with sunitinib (50mg/day for 4 out of 6 weeks)
16199101|NCT01402089|Drug|Erlotinib|Patients with non small-cell lung cancer receive conventional treatment with erlotinib 150mg/day.
16199102|NCT01402089|Drug|Midazolam|For phenotyping of CYP3A4, all patients receive one-time midazolam 2mg as a drinking solution at the start of study treatment.
16199103|NCT01402089|Drug|Caffeine|For phenotyping of CYP1A2, patients with non small-cell lung cancer receive additionally one-time caffeine 100mg as a tablet.
16199104|NCT01402076|Drug|Tasimelteon|20mg daily dosing, Days 4-20
16199105|NCT01402076|Drug|Rosiglitazone|4mg, single dose, Days 3 and 20
16199106|NCT01402076|Drug|Midazolam|10mg, single dose, Days 1 and 18
16199107|NCT01402063|Drug|PPX (CT2103)|XRT: 60 Gy at 2 Gy/fraction x 30 fractions PPX: 50 mg/m2/week x 6 weeks during radiation Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum.
16199108|NCT01402063|Drug|Temozolomide|XRT: 60 Gy at 2 Gy/fraction x 30 fractions Temozolomide, 75 mg/m2/day, 7 days per week, from the first to the last day of radiotherapy Temozolomide maintenance: Beginning 4 weeks after completion of chemoradiation, temozolomide d1-5 of 28 day cycle for 12 cycle maximum
16199109|NCT01402050|Drug|CERVIDIL (Dinoprostone)|INDUCTION OF LABOR
16199110|NCT01402050|Device|FOLEY BALLOON|INDUCTION OF LABOR
16199111|NCT01402037|Drug|Glucose|Glucose 20% intravenous
16199112|NCT01402037|Device|Continuous glucose monitoring|Blood glucose profiles: during 5 days glucose profiles will be determined by seven-point self-monitoring of blood glucose (SMBG) (pre-breakfast: assumed time 7 am, post-breakfast: 8.30 am, pre-lunch: 12 am, post-lunch: 1.30 pm, pre-supper: 6 am, post-supper: 7.30 pm, bedtime: 10 pm) and by continuous glucose monitoring (CGM). Participants will be blinded for the CGM results.
16199175|NCT01401426|Procedure|Laparoscopic vertical sleeve gastrectomy|Laparoscopic vertical sleeve gastrectomy for the treatment of morbid obesity.
16199176|NCT01401426|Procedure|Laparoscopic vertical sleeve gastrectomy|Laparoscopic vertical sleeve gastrectomy
16199177|NCT01401413|Drug|ramelteon|8 mg nightly for 30 nights
16199216|NCT01401062|Drug|Fresolimumab|
16199113|NCT01402024|Drug|Aprepitant|"The patient on study group with weight category of 15-40 kg will receive:
~D1- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant 80 mg; D2- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant 80 mg; D3- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant 80 mg and
~The patient with weight category of 41-65 kg in study group will receive:
~D1- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant 125 mg; D2- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant 80 mg; D3- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant 80 mg"
16199114|NCT01402024|Drug|Placebo|"Patient on control group with weight category of 15-40 kg will receive:
~D1- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant placebo 80 mg; D2- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant placebo 80 mg; D3- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant placebo 80 mg; and
~The patient on control group with weight category of 41-65 kg will receive:
~D1- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant placebo 125 mg; D2- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant placebo 80 mg; D3- Dexamethasone 0.15 mg/kg, ondansetron (0.15 mg/kg, single dose), Aprepitant placebo 80 mg (all are injectable except Aprepitant oral capsule)."
16199115|NCT01402011|Procedure|25% dextrose in shoulder entheses|injections of 1 mL of 25% dextrose and .1% lidocaine solution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula.
16199116|NCT01402011|Procedure|.1% lidocaine in shoulder entheses|injections of 1 mL of .1% lidocaine 'ssolution in the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic the insertion of the teres minor and the triceps on the scapula.
16199117|NCT01402011|Procedure|.1% lidocaine subcu. above shouldr enth.|injections of 1 mL of .1% lidocaine solution subcutaneously, above the following tendons: supraspinatus, infraspinatus, teres minor ( on greater tuberosity), subscapularis ( on lesser tuberosity), long tendon of biceps ( on supra-glenoid tubercle), short tendons of biceps on coracoid process, and the inferior glenohumeral ligament, anteriorly and posteriorly. If symptomatic, above the insertion of the teres minor and the triceps on the scapula.
16199118|NCT01401985|Drug|TD-1211|Capsules
16199119|NCT01401985|Drug|Placebo|Capsules
16199120|NCT01401959|Drug|Eribulin|1.4 mg/m^2 IV Days 1 and 8, every 21 days for six cycles
16199121|NCT01401959|Drug|Trastuzumab|6 mg/kg IV Day 1 every 21 days
16199122|NCT01401946|Drug|soy isoflavones|
16199123|NCT01401946|Drug|Placebo|
16199124|NCT01401933|Drug|Linifanib|QD on Days 1 and 13
16199125|NCT01401933|Drug|Rifampin|QD on Days 5-16
16199126|NCT01401920|Other|leg elevation|bilateral passive leg elevation for 30 seconds
16199127|NCT01401920|Other|Trendelenburg position|Trendelenburg position (15 degrees) for 30 seconds
16199128|NCT01401920|Other|Trendelenburg position + passive leg elevation|Trendelenburg position + passive leg elevation
16199129|NCT01401920|Other|control group|supine position without passive leg elevation or trendelenburg position
16199130|NCT01401907|Other|early palliative care|patient assigned to the intervention will receive early palliative care along with standard oncology care.
16199131|NCT01401868|Drug|ME-143|"experimental drug, dose escalation with 4 dose cohorts of 2.5 mg/kg, 5 mg/kg, 10 mg/kg, 20 mg/kg; Cycle 1 is 3 weekly IV infusions on Days 1, 8 and 15. If either the 10 mg/kg or 20 mg/kg dose levels are not tolerable, a 7.5 mg/kg or a 15 mg/kg dose level will be evaluated. After safety assessment, if there is clinical benefit, weekly dosing may continue until withdrawal.
~Once the highest tolerated dose has been determined, patients will be enrolled to receive IV infusions 2-days per week. Cycle 1 at the highest dose level is 3 weekly IV infusions on Days 1, 2, 8, 9, 15 and 16. After safety assessment, if there is clinical benefit, weekly dosing may continue until withdrawal."
16199132|NCT01401842|Other|Lumbar ext. high intensity progressive resistance exercise|1 active set of 1 exercise, 1x/week, 11 weeks
16199133|NCT01401842|Other|Low intensity core stabilization exercise|1 set of 5 exercises, 1x/week, 11 weeks
16199134|NCT01401829|Behavioral|150 weekly minutes walking|12 week physical activity intervention group with a goal of 150 minutes of moderate intensity exercise (walking) per week on a treadmill while supervised by exercise specialists who are certified by ACSM and trained and monitored for quality control and safety
16199135|NCT01401829|Behavioral|75 weekly minutes walking|12 week physical activity intervention group with a goal of 75 minutes of moderate intensity exercise (walking) per week on a treadmill while supervised by exercise specialists who are certified by ACSM and trained and monitored for quality control and safety
16199136|NCT01401829|Behavioral|Stretching/Flexibility exercise|12 week stretching intervention group with a goal of 3 sessions per week while supervised by exercise specialists who are certified by ACSM and trained and monitored for quality control and safety
16199137|NCT01401816|Other|Text Message|Subjects will receive a text message on their personal cell phone on Days 1, 3 and 5 after enrollment reminding them to fill their prescription.
16199138|NCT01401803|Drug|Dysport|Patients entering will be based on gender and assessment of the glabella region (including the corrugators, procerus, and medial frontalis muscles). Muscle mass will be graded separately for males and females as +, ++, or+++ (light/small, moderate/medium, or heavy/large). Male patients will receive 0.3 mL to 0.4 mL (60, 70, or 80 units) in five equally divided doses of Dysport™ and female patients will receive 0.25 mL to 0.35 mL (50, 60 or 70 units) in equally divided doses of Dysport™ at 5 designated injection sites in the glabellar region. On (Day0) patients will be treated with Dysport™ 10 to 20 units bilaterally to the depressor component of the orbicularis. The dosing for patients will be based on assessment of orbicularis muscle mass. Patients will receive .05 mL to 0.1 mL (10 or 20 units) in two equally divided doses of Dysport™. Muscle mass will not be graded based upon gender for this region.
16199178|NCT01401413|Drug|placebo|placebo control i pill nightly for 30 nights
16199217|NCT01401062|Radiation|Radiation Therapy|
16199301|NCT01400477|Drug|DMXB-A-SR|Experimental Study Drug: 3-2, 4 dimethoxybenzylidene anabaseine sustained release (DMXB-A-SR)
16199139|NCT01401790|Device|Telehomecare (Intelligent Distance Patient Monitoring)|"Randomized patients were to be taugth and to use for 3 months a telehomecare program designed for
~Automatic download of blood glucose levels
~Automatic alerts indicating hypoglycemias, hyperglycemias and ketones to the medical team
~Changes in treatment plan by the diabetes professionals
~E mail exchanges between families and health care professionals
~Reinforcement of teaching program"
16199140|NCT01401790|Other|Standard education and follow up at diabetes clinic|Patients allocated to the control branch receive standard diabetes teaching and care.
16199141|NCT01401764|Other|Formulation buffers|Platform II: Histidine, Polysorbate-80 PASS: Phosphate, Arginine, NaCl ARG 100: Phosphate, 100 mM Arginine
16199142|NCT01401751|Device|Hypoglycemia-Hyperglycemia Minimizer System|Hypoglycemia-Hyperglycemia Minimizer System, consisting of an subcutaneous insulin infusion pump, subcutaneous continuous glucose monitoring system, and a controller algorithm
16199143|NCT01401725|Behavioral|Electronic Order Entry System + CDSS|Physicians at this hospital will use an Electronic Order Entry System plus a computerized decision support system (CDSS) to support VTE prophylaxis decisions.
16199144|NCT01401725|Behavioral|Electronic Order Entry System Only|Physicians at this hospital will use an Electronic Order Entry System
16199145|NCT01401725|Other|Usual Care|Physicians at this hospital will practice usual care (no Electronic Order Entry System and no CDSS for VTE prophylaxis decisions)
16199146|NCT01401712|Procedure|ON-Q® Pain Relief System|Identify insertion site lateral to paraspinous muscles and posteromedial to the rib fractures. Then, incise skin and soft tissue down to the level of the rib. Advance tunneler perpendicular to chest wall until it contacts the rib, then, advance superiorly at 45° angle in the extrathoracic space. Remove tunneler and advance catheter in space created. Attach catheter to pump filled with 0.2% ropivacaine at infusion rate of 2-12ml/hr.
16199147|NCT01401712|Procedure|Thoracic epidural catheter|Introduce needle into the interspinous space of the vertebral column and advance into the epidural space. Advance the epidural catheter about 3-5 cm into the epidural space and remove the needle.
16199148|NCT01401699|Device|Optical Frequency Domain Imaging (OFDI)|Optical Frequency Domain (OFDI) imaging of esophagus
16199149|NCT01401673|Drug|Indantadol|Titration
16199150|NCT01401660|Other|Physical Therapy|The physician will complete a physical exam as well as analyze a completed CERSR® scan study to determine the root cause of the low back pain. The physician will then prescribe a targeted physical therapy regime to address the cause of the low back pain.
16199151|NCT01401647|Drug|amiodarone|300 mg will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 150 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 150 mg, followed by a second dose of 150 mg if the VF/pulseless VT persists.
16199152|NCT01401647|Drug|Lidocaine|120 mg will be given IV/IO push with reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 60 mg will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 60 mg, followed by a second dose of 60 mg if the VF/pulseless VT persists.
16199153|NCT01401647|Other|Normal saline|6 cc of normal saline (NS) will be given IV/IO push for reoccurrence of ventricular fibrillation or pulseless ventricular tachycardia after 1 or more shocks. A second dose of 3 cc will be given if VF/pulseless VT reoccurs after initial dose and a subsequent shock. The initial dose for patients estimated to be less than 100 pounds will be 3 cc, followed by a second dose of 3 cc if the VF/pulseless VT persists.
16199154|NCT01401634|Other|Oral water|2 Liters of water given orally
16199155|NCT01401634|Other|Intravenous normal saline|2 Liters Intravenous normal saline
16199156|NCT01401621|Behavioral|Scratchoff Prompt: Name of Test|A prompt will have the recipient scratch off the message that reveals the name of the test that the recipient needs
16199157|NCT01401621|Behavioral|Scratchoff Prompt: Call to Action|A prompt will have the recipient scratch off the message to find out how to follow the recommendation that the test be received.
16199158|NCT01401621|Behavioral|Control|No scratch-off element
16199159|NCT01401608|Device|RF Ablation|Ablation of arrhythmogenic ventricular tissue
16199160|NCT01401595|Drug|escitalopram oxalate|The purpose of this study is to determine the effectiveness of the anti-depressant Lexapro in the treatment of the Night Eating Syndrome. An ADAM SPECT-CT study of SERT binding will be conducted which will compare SERT binding in 31 night eaters with that of 10 control subjects. The first procedure will be to assess SPECT-CT images of night eaters and controls following up our pilot SPECT study of night eaters and controls. Medication will be administered starting at 10 mg daily, with increase up to 20 mg, as indicated and tolerated, for up to three months. Visits will occur at baseline and weeks 1, 2, 4, 6, 8, 10, and 12.
16199161|NCT01401582|Other|Implementation of Dementia Care Manager|"Home-visits of trained Dementia Care Manager (DCM) at least monthly for 6 months. The DCM will, in close cooperation with the general practitioner, establish and include a subsidiary support system for subjects and their caregivers."
16199162|NCT01401569|Behavioral|Exercise and counseling (for smoking cessation and physical activity)|Exercise and counseling (for smoking cessation and physical activity)
16199163|NCT01401556|Other|case management|
16199164|NCT01401556|Other|Multifaceted quality improvement intervention|
16199165|NCT01401543|Drug|LY2452473|Administered orally
16199166|NCT01401543|Drug|Tadalafil|Administered orally
16199167|NCT01401543|Drug|LY900010|Administered orally
16199168|NCT01401530|Biological|denileukin diftitox (E7777)|E7777 will be administered by intravenous (IV) infusion for 5 days from Day 1 through 5 of each cycle (21 days/cycle) with 8 cycles in maximum for E7777 alone therapy. E7777 dose will be escalated from 6 micro-g/kg/day to 12, 15 and then to 18 in a stepwise fashion.
16199169|NCT01401517|Drug|sodium nitrite|0, 40 or 80 mg twice each day for 10 weeks followed by a 1 week escalation of 2 times the dose.
16199170|NCT01401504|Drug|ASP3026|oral
16199171|NCT01401491|Drug|clozapine plus fluvoxamine|clozapine 100 mg/day plus fluvoxamine 50 mg/day
16199172|NCT01401491|Drug|clozapine plus placebo|clozapine 300 mg/day plus placebo
16199173|NCT01401465|Drug|ciclesonide|74 mcg ciclesonide nasal aerosol once daily
16199174|NCT01401465|Drug|mometasone|200 mcg mometasone aqueous nasal spray once daily
16199179|NCT01401387|Other|Timing of start treatment with pancreatic enzymes|Patients who are randomised to standard treatment will start taking pancreatic enzymes only if they develop steatorrhea-related symptoms in combination with at least a 10% decrease in body weight (index weight at the time of randomisation).
16199180|NCT01401387|Other|Timing of start treatment with pancreatic enzymes|Patients who are allocated to the anticipative group will start enzyme suppletion immediately and receive dietary consultation after randomization, regardless of symptoms.
16199181|NCT01401361|Device|Treatment Arm|The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .
16199182|NCT01401335|Behavioral|Questionnaires|questionnaires at entry, month 4, 8 and 12
16199183|NCT01401322|Drug|Lenalidomide|50 mg; po
16199184|NCT01401296|Behavioral|Deprexis|Behavioral: Deprexis (10 sessions) delivered online versus wait-list control group
16199185|NCT01401296|Behavioral|Wait-list|Behavioral: the wait-list group receives Deprexis after 8 weeks
16199186|NCT01401283|Device|measurement of cardiac output and pulse pressure variation|hemodynamic optimization according to cardiac index and pulse pressure variation
16199187|NCT01401270|Behavioral|prize contingency management|Participants earn the chance to win prizes for the targeted behavior, cocaine abstinence.
16199188|NCT01401257|Drug|PXT3003 Low dose|Liquid,5 ml, twice a day, 12-month treatment
16199189|NCT01401257|Drug|PXT3003 Intermediate Dose|Liquid,5 ml, twice a day, 12-month treatment
16199190|NCT01401257|Drug|PXT3003 High Dose|Liquid,5 ml, twice a day, 12-month treatment
16199191|NCT01401257|Other|Placebo|Liquid,5 ml, twice a day, 12-month treatment
16199192|NCT01401244|Drug|somatropin|A single dose 4.0 mg administered subcutaneously (under the skin) via Norditropin® FlexPro® pen
16199193|NCT01401244|Drug|somatropin|A single dose 4.0 mg administered subcutaneously (under the skin) via Genotropin® Pen 12
16199194|NCT01401231|Behavioral|Behavioral activation psychotherapy|Up to 10 sessions of behavioral activation psychotherapy delivered in person or by telephone.
16199195|NCT01401231|Other|Usual care|Continued usual care (could include referral for medication or psychotherapy)
16199196|NCT01401218|Other|Electronic Medical Record (EMR) Review|"measurements of potential risk factors of acute kidney injury through the patients' previous medical record review.
~potential risk factors include previous history of hypertension, diabetes, cerebrovascular events, peripheral arterial disease, chronic obstructive pulmonary disease, recent myocardial infarction, coronary artery disease; preoperative glomerular filtration rate, preoperative creatinine level, preoperative cardiac ejection fraction reported on echocardiography, use of preoperative inotropics, use of deep hypothermic cardiac arrest, intraoperative colloid use, intraoperative blood product transfusion, total time of cardiopulmonary bypass,"
16199197|NCT01401205|Other|upper airway ultrasonographic examination|upper airway ultrasonographic examination and cuff leak test
16199198|NCT01401192|Drug|Gemcitabine plus cisplatin|Gemcitabine 1000mg/m2 D1, D8 & cisplatin 70mg/m2 D1 every 3 weeks
16199199|NCT01401192|Drug|pemetrexed plus cisplatin|Pemetrexed 500mg/m2 & cisplatin 70mg/m2 D1 every 3 weeks
16199200|NCT01401192|Drug|pemetrexed plus cisplatin|pemetrexed 500mg/m2 & cisplatin 70mg/m2 every 3 weeks
16199201|NCT01401192|Drug|Gemcitabine plus cisplatin|Gemcitabine 1000mg/m2 D1, D8 & cisplatin 70mg/m2 D1 every 3 weeks
16199202|NCT01401179|Drug|cefazolin, erythromycin, clarithromycin|Antibiotics regimen was one of cefazolin or cefazolin plus erythromycin or cefazolin plus clarithromycin. Intravenous 1g cefazolin was given every 6 hours after negative result skin test for allergic reaction. With cefazolin plus erythromycin group or cefazolin plus clarithromycin, cefazolin was given with same protocol and 250mg oral erythromycin every 6 hours or 500mg oral clarithromycin every 12 hours was added. All antibiotics were given for 7 days or until delivery.
16199203|NCT01401166|Drug|Herceptin|Herceptin will be given on Day 1 of each 3-week cycle for a total of 18 cycles. If study treatment for Cycle 1 is IV Herceptin, the initial dose will be a loading dose of 8 milligrams per kilogram (mg/kg) for de novo participants who start Herceptin treatment in the study. For all other cycles where IV Herceptin is given and for non-de novo participants, the dose will be 6 mg/kg. The SC dose will be 600 milligrams (mg) for both the SID and vial formulations for all cycles where SC Herceptin is given.
16199204|NCT01401166|Drug|Herceptin|Herceptin will be given on Day 1 of each 3-week cycle for a total of 18 cycles. If study treatment for Cycle 1 is IV Herceptin, the initial dose will be a loading dose of 8 mg/kg for de novo participants who start Herceptin treatment in the study. For all other cycles where IV Herceptin is given and for non-de novo participants, the dose will be 6 mg/kg. The SC dose will be 600 mg for both the SID and vial formulations for all cycles where SC Herceptin is given.
16199205|NCT01401166|Device|Single-Use Injection Device|The SID will be used, containing Herceptin 600 mg per 5 milliliters (mL).
16199206|NCT01401166|Device|Single-Use Injection Device|The SID will be used, containing Herceptin 600 mg per 5 mL.
16199207|NCT01401153|Other|Skipping lunch|Just water.
16199208|NCT01401140|Drug|St Thomas|Once the upper aorta has been clamped, the cardioplegic solution St Thomas will be administered directly into it via an anterograde approach. St Thomas will be infused every 30 minutes at a dosage of 10ml/kg bodyweight (infusion takes about three minutes). If the heart appears to be starting again (ventricular fibrillation) for more than three minutes, infusion will be resumed at the same rate until the heart is effectively stopped.
16199209|NCT01401140|Drug|Custodiol|Once the upper aorta has been clamped, the cardioplegic solution Custodiol will be administered directly into it via an anterograde approach. Custodiol will be injected in one bolus (20 ml/kg), which takes eight minutes. If the heart appears to be starting again (ventricular fibrillation) for more than three minutes, infusion will be resumed at the same rate until the heart is effectively stopped.
16199210|NCT01401114|Drug|E2/LNG oral (Wellnara, BAY86-5029)|Patients in daily life treatment receiving Wellnara for postmenopausal osteoporosis
16199211|NCT01401101|Other|PCM|Care Manager (CM) intervention
16199212|NCT01401101|Other|MEU|The MEU condition consists of only the clinician education and patient screening without written feedback.
16199213|NCT01401088|Device|Artificial drainage implant|Artificial drainage implant is used for intra ocular pressure reduction in patient with refractory glaucoma
16199214|NCT01401075|Drug|mistletoe extract|subcutaneous injections thrice weekly with 1 ml in 4 increasing doses
16199218|NCT01401049|Drug|Fospropofol|To compare the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion) versus the test drug fospropofol. A third arm will also be included using a current standard (propofol plus lidocaine) as a methodological control.
16199219|NCT01401049|Drug|Propofol/Lidocaine|We plan to assess the incidence and intensity of pain on injection that is caused by propofol (lipid emulsion).
16199220|NCT01401036|Device|Biolimus A9 eluting stents|implantation of Biolimus A9 eluting stents
16199221|NCT01401036|Procedure|uncoated stent|implantation of any uncoated bare metal stents currently available in Japan
16199222|NCT01401023|Drug|Tigecycline|: Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 milligram loading dose followed by 50 milligrams every 12 hours) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy.
16199223|NCT01401010|Drug|Doripenem|500 mg every 8 hours
16199224|NCT01401010|Drug|doripenem|1000 mg every 8 hours
16199225|NCT01400997|Device|easypod™|Saizen (Somatotropin) as per Summary of Product Characteristics (SmPC) administered by easypod™
16199226|NCT01400984|Device|easypod™|Saizen (Somatotropin) as per Summary of Product Characteristics (SmPC) administered by easypod™
16199227|NCT01400958|Drug|Nuvigil®|Nuvigil® 150 mg/day x 42 days THEN, No More Drug
16199228|NCT01400958|Drug|Placebo|Placebo x 42 days; THEN, No More Placebo
16199229|NCT01400945|Drug|AGSPT201 Tab contains S-pantoprazole|comparison of Pantoloc Tab 40mg
16199230|NCT01400932|Drug|GI148512|GI148512, Topical gel in 1 g containing benzoyl peroxide 30 mg
16199231|NCT01400932|Drug|vehicle gel|Matching vehicle gel of GI148512, not containing active ingredient (benzoyl peroxide)
16199232|NCT01400919|Device|Protégé® EverFlex™ Self-Expanding Stent System, and Protégé® GPS™ Self-Expanding Stent System.|Implantation of one or more study devices in the common and/or external iliac artery.
16199233|NCT01400906|Drug|100 micrograms Fluticasone propionate|100 micrograms micronized drug blended with lactose in dry powder inhalator
16199234|NCT01400906|Drug|500 micrograms Fluticasone propionate|500 micrograms micronized drug blended with lactose in dry powder inhalator
16199235|NCT01400906|Drug|lactose powder|lactose powder in dry powder device : placebo comparator
16199236|NCT01400893|Device|SCD|The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits.
16199237|NCT01400867|Drug|Ceftaroline fosamil|"Subjects ≥ 6 months old: 12 mg/kg IV for subjects weighing ≤ 33 kg and 400 mg for subjects weighing > 33 kg will be infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour)
~Subjects < 6 months old: 8mg/kg infused over 60 (± 10) minutes every 8 hours (q8h) (± 1 hour)"
16199238|NCT01400867|Drug|Vancomycin +/- Aztreonam or Cefazolin +/- Aztreonam|"Vancomycin 15mg/kg IV over 60 minutes (or a maximum of 10mg/min whichever is longer) +/- Aztreonam 30 mg/kg IV every 8 hours over 60 minutes (for infections involving gram negative pathogen suspected or confirmed)
~Cefazolin 75mg/kg IV divided every 8 hours over 60 minutes (for sites that do not empirically cover for MRSA) +/- Aztreonam 30 mg/kg IV every 8 hours over 60 minutes (for infections involving gram negative pathogen suspected or confirmed"
16199239|NCT01400867|Drug|Cephalexin or Clindamycin or Linezolid|"Possible oral switch on or after study day 4.
~Cephalexin: 25 mg/kg q6h PO or Clindamycin: 10 mg/kg q8h PO or Linezolid 600mg q12h (cohort 1) or 10 mg/kg q8h (cohorts 2,3 and 4) PO."
16199240|NCT01400854|Drug|Effentora®|prescribed as per local Summary of Product Characteristics (SmPC) for 4 weeks duration
16199241|NCT01400841|Device|HAART 300 Annuloplasty Device|Implantation of device for aortic valve repair
16199242|NCT01400828|Drug|Bilastine|20 mg (encapsulated) tablets QD/14 days
16199243|NCT01400828|Drug|Desloratadine|5 mg (encapsulated) tablets QD/14 days
16199244|NCT01400828|Drug|Placebo|(encapsulated) Tablets QD/14 days
16199245|NCT01400815|Drug|X-22 Smoking Cessation Product|"The X-22 Smoking Cessation Product is a tobacco-based (botanical) medical product consisting of very low nicotine (VLN) cigarettes.
~Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period."
16199246|NCT01400815|Drug|Active Control Cigarettes|"The Active Control cigarette is identical to the X-22 cigarette except for the tobacco, which has a nicotine content similar to that of a conventional light cigarette.
~Subjects will be allowed to smoke as much as desired throughout the 6-week treatment period."
16199247|NCT01400802|Biological|Insulin Lispro|Dosage form- Subcutaneous Injection
16199248|NCT01400789|Biological|Insulin Lispro|Dosage form- Subcutaneous Injection
16199249|NCT01400776|Drug|WC3011 Vaginal Gel|WC3011 Vaginal Gel administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks
16199250|NCT01400776|Drug|Vehicle|Vehicle Vaginal Gel administered once daily for 2 weeks followed by 2X/week or 3X/week for 10 weeks, total treatment duration 12 weeks.
16199251|NCT01400763|Dietary Supplement|Fresh lutein-enriched egg-yolk beverage|Fresh lutein-enriched egg-yolk beverage
16199252|NCT01400763|Dietary Supplement|Dried-1 lutein-enriched egg-yolk beverage|Dried-1 lutein-enriched egg-yolk beverage
16199253|NCT01400763|Dietary Supplement|Dried-2 lutein-enriched egg-yolk beverage|Dried-2 lutein-enriched egg-yolk beverage
16199254|NCT01400763|Dietary Supplement|Placebo beverage|Placebo beverage
16199255|NCT01400750|Drug|oral ciprofloxacin plus inhaled colistin|oral ciprofloxacin (30mg/kg/day divided in 2 doses) for 3 months (CC) plus inhaled colistimethate sodium(Colistineb® 2x2 mill U daily)
16199256|NCT01400750|Drug|TOBI|tobramycin inhalation solution (TOBI® 2x300 mg) for 28 days
16199257|NCT01400737|Drug|ibuprofen|The prophylaxis group received ibuprofen suspension at a dosage of 10 mg/kg via an orogastric tube, followed by 0.5 ml of distilled water. The first dose was given within the first 24 hours of life. The second and third doses were given within 24 and 48 hours after the first dose respectively.
16199299|NCT01400503|Drug|Siltuximab|Type=exact number, unit=mg/kg, number=11, form=intravenous solution, route=intravenous. Siltuximab given as a 1-hour infusion every 3 weeks.
16199258|NCT01400737|Drug|ibuprofen|The prophylaxis group received ibuprofen suspension at a dosage of 10 mg/kg via an orogastric tube, followed by 0.5 ml of distilled water. The first dose was given within the first 24 hours of life. The second and third doses were given within 24 and 48 hours after the first dose respectively
16199259|NCT01400724|Dietary Supplement|Inofolic NRT|Dietary supplement: myo-inositol 2000 mg plus cocoa polyphenols 30 mg and plus isoflavones 80 mg
16199260|NCT01400711|Other|ERAS perioperative care|Patient's education before surgery, early mobilization and oral feeding after surgery, no opioids analgesics.
16199261|NCT01400711|Other|Traditional|Nasogastric tube until bowel function, late oral eating, opioid analgesics.
16199262|NCT01400698|Drug|Saizen® A|Continuous or intermittent treatment with recombinant human Growth Hormone (r-hGH) 0.067 milligram/kilogram/day (mg/kg/day) subcutaneously (sc).
16199263|NCT01400698|Drug|Saizen® B|Observed until the first signs of puberty and then continuous treatment with r-hGH 0.067 mg/kg/day sc or observed without treatment.
16199264|NCT01400698|Other|Observation only|Subjects were only observed.
16199265|NCT01400685|Drug|Lenalidomide|Lenalidomide will be dose escalated until the maximum tolerated dose is reached. The starting dose is 2.5mg, followed by 5mg, followed by 10mg.
16199266|NCT01400685|Drug|Bendamustine|90 mg/m^2 IV days 1-2 of each cycle for 6 cycles
16199267|NCT01400685|Drug|Rituximab|375 mg/m^2 IV day 1 (cycle 1), 500 mg/m^2 day 1 (cycles 2-6)
16199268|NCT01400672|Biological|Tumor Lysate Vaccine|Vaccination is injected intradermally every 2 weeks for 4 doses, then every 4 weeks for up to 1 year. Patients will receive 1 mg protein divided into 2 doses at two separate subinguinal sites.
16199269|NCT01400672|Drug|Imiquimod|Marketed as 5% Aldara cream topically applied; total of 12.5 mg divided between the two vaccination sites and reapplied at the vaccination sites 24 hours later.
16199270|NCT01400672|Radiation|Radiation therapy|"Initial course of radiation therapy is given over 6-7 weeks, 5580 cGy. At the time of the 3rd vaccination, an additional 180 cGy fractions will be delivered in single doses in a novel effort to induce NKG2D ligand upregulation (thereby sensitizing residual tumor to lymphocyte attack). The total radiation dose for each patient will be 5760 cGy."
16199271|NCT01400659|Procedure|CFP counting|Patients receive a standardized test meal at lunch time. The required insulin dose is calculated by CFP counting. Insulin is given as bolus and basal rate using an insulin pump. Continuous glucose monitoring is performed by sensor-augmented pump system for 6 hours after the meal. The intervention is taking part under in-patient clinical conditions.
16199272|NCT01400659|Procedure|CARB counting|Patients receive a standardized test meal at lunch time. The required insulin dose is calculated by CARB counting. Insulin is given as bolus and basal rate using an insulin pump. Continuous glucose monitoring is performed by sensor-augmented pump system for 6 hours after the meal. The intervention is taking part under in-patient clinical conditions.
16199273|NCT01400646|Drug|Rivaroxaban|Type=exact number, unit=mg, number=20, form=tablet, route=oral use. One tablet once daily for 5 days (Treatment Period 1, Days 1-7).
16199274|NCT01400646|Drug|Warfarin|Type=exact number, unit mg, number=10, form=tablet , route=oral use. One tablet for 2-4 days (Treatment Period 1, Day 6 up to Day 11).
16199275|NCT01400646|Drug|Vitamin K|Type=exact number, unit=mg, number=1, form=oral solution, route=oral use. 1 mg dose for 1 day (Treatment Period 1, Day 12).
16199276|NCT01400646|Drug|Vitamin K|Type=exact number, unit=mg, number=5, form=oral solution, route=oral use. 5 mg dose for 1 day (Treatment Period 2, Day 7).
16199277|NCT01400646|Drug|Warfarin|Type-exact number, unit=mg, number=10, form=tablet, route=oral use. Tablet(s) administered once daily for 2-4 days (Treatment Period 2, Day 1 up to Day 6)
16199278|NCT01400646|Drug|Warfarin|Type=range, unit=mg, number=0-15, form=tablet, route=oral use. Tablet(s) taken once daily for up to 4 days after Warfarin 10 mg administered as monotherapy for 2-4 days (Treatment Period 1).
16199279|NCT01400646|Drug|Warfarin|Type=range, unit=mg, number=0-15, form=tablet, route=oral use. Tablet(s) taken once daily for up to 4 days after Warfarin 10 mg administered as monotherapy for 2-4 days (Treatment Period 2).
16199280|NCT01400633|Drug|decitabine injection|decitabine intravenous injection 20mg/m2 once a day for 5 consecutive days every 4 weeks
16199281|NCT01400620|Drug|IZN-6N4|Oral rinse containing 1% botanical extracts, 15 cc rinse 3 times per day, for up to 9 weeks
16199282|NCT01400607|Biological|Neocartilage Implant/DeNovo® ET (Engineered Tissue Graft)|The Neocartilage Implant is a cartilage repair technology cultured from juvenile human cartilage cells.
16199283|NCT01400607|Other|Microfracture|Marrow stimulation using the microfracture technique; performed arthroscopically
16199284|NCT01400594|Drug|HTU-520 Patch|Terbinafine hydrochloride patch
16199285|NCT01400594|Other|Placebo Patch|Treatment with Placebo Patch
16199286|NCT01400581|Behavioral|Collaborative Care Intervention|See description of Intervention arm
16199287|NCT01400568|Drug|LPS challenge with nebulized LPS|20,000 EU of Clinical Center Reference Endotoxine (CCRE) will be applied by an AKITA® Jet Nebulizer under the constant supervision of the site staff.
16199288|NCT01400568|Drug|fluticasone propionate (FP)|The dosage of FP will be 2 mg. This dosage will be inhaled by 4 puffs of Flutide® forte 500 Diskus® 500 µg / dose according to the package insert.
16199289|NCT01400555|Drug|Cohort 4|Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 750 mg/day + prednisone 10 mg/day
16199290|NCT01400555|Drug|Cohort 3|Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 1000 mg/day + prednisone 10 mg/day
16199291|NCT01400555|Drug|Cohort 2|Docetaxel 75 mg/m2 administered once every 3 weeks + abiraterone acetate 500 mg/day + prednisone 10 mg/day
16199292|NCT01400555|Drug|Cohort 1|Docetaxel 60 mg/m2 administered once every 3 weeks + abiraterone acetate 500 mg/day + prednisone 10 mg/day
16199293|NCT01400542|Device|CPAP Treatment|Patients with obstructive sleep apnea syndrome will be treated by Continuous Positive Airway Pressure (CPAP) at home during all 4 months all nights.
16199294|NCT01400542|Device|No treatment|no treatment
16199295|NCT01400516|Drug|Teriparatide|20 μg, subcutaneous injection, 1 injection per day
16199296|NCT01400516|Drug|calcium citrate|1000 mg of calcium citrate
16199297|NCT01400516|Drug|Vitamin D|800 IU of Vitamin D
16199298|NCT01400516|Drug|TNF antagonist|TNF antagonist as prescribed in clinical practice (such as etanercept or adalimumab)
16199303|NCT01400464|Drug|Prednisone therapy and pharmacokinetic|Prednisone therapy delivered in accordance with a 10 to 18 month pre-defined schedule. Pharmacokinetic and pharmacogenetic tests at 14 or 28 days. Monthly visit for the first 6 month, then every 8 weeks months thereafter for the remainder of the study with standard biologic monitoring , physical exam and medical and medication history .Also, participants will be asked to complete several questionnaires to assess quality of life and observance to therapy. Participants may have additional study visits if a disease flare or disease-related complications occur during the study.
16199304|NCT01400451|Drug|Ipilimumab (BMS-734016)|Injection, intravenous (i.v.), cohort 1: 3 mg/kg, Escalate to cohort 2: 10 mg/kg, Escalate to cohort 3: at Recommended Phase 2 Dose (RP2D), De-escalate cohort 1A: 3 mg/kg, De-escalate cohort -1B: 10 mg/kg, (every three week) Q3wk, upto 2 yrs
16199305|NCT01400451|Drug|Vemurafenib|tablets, oral, cohort 1: 960 mg Twice daily (BID) x 28 days after date, cohort 2: 960 mg BID x 28 days after date, cohort 3: at Recommended Phase 2 Dose (RP2D) x 14 days after date, De-escalate cohort 1A: 720 mg BID x 28 days after date, De-escalate cohort -1B: 720 mg BID x 28 days after date , Up to 2 yrs
16199306|NCT01400438|Other|questionnaires|delivery of questionnaires and self-psychological interview
16199307|NCT01400438|Other|questionnaires|delivery of questionnaires and self-psychological interview
16199308|NCT01400425|Drug|florbetapir F 18|IV injection, 370 megabecquerel (MBq) (10 millicurie [mCi]), single dose
16199309|NCT01400412|Drug|Darunavir|Darunavir was administered orally once a day as two 400 mg tablets with food. When the 800 mg formulation tablet became available, it was substituted for the two 400 mg tablet.
16199310|NCT01400412|Drug|Ritonavir|Ritonavir was administered orally together with darunavir as one 100 mg tablet once daily with food.
16199311|NCT01400412|Drug|Tenofovir disoproxil fumarate|Tenofovir disoproxil fumarate was administered orally as one 300 mg tablet once a day.
16199312|NCT01400412|Drug|Emtricitabine|Emtricitabine was administered orally once a day as one 200 mg capsule.
16199313|NCT01400412|Drug|Placebo for Tenofovir disoproxil fumarate|Placebo for tenofovir disoproxil fumarate was administered orally once a day as one tablet.
16199314|NCT01400412|Drug|Placebo for Maraviroc|Placebo for maraviroc was administered orally once a day as one tablet.
16199315|NCT01400412|Drug|Maraviroc|Maraviroc was administered orally once a day as one 150 mg tablet.
16199316|NCT01400386|Other|Coffee bioavailability trial|Coffee bioavailability trial
16199317|NCT01400373|Device|Prehospital intra-nasal cooling with RhinoChill|Patients in the intervention group will receive prehospital intra-nasal cooling with RhinoChill as soon as possible during the resuscitation (i.e. intra-arrest). Intra-nasal cooling will be ongoing until systemic hypothermia is started at the intensive care unit.
16199318|NCT01400360|Other|Combination of TBA and intraarterial application of vasodilators|In the invasive arm CVS should be treated by intraarterial therapy and efficacy controlled by CT or MRI after 48 hours and if necessary repeated.
16199319|NCT01400334|Radiation|Positron Emission Tomography|Quantification of cardiac function using positron emission tomography and: a)11C-meta-hydroxyephedrine [HED, 20 mCi (740 MBq)] to quantify sympathetic nerve function, b) 13N-ammonia [NH3, 20 mCi (740 MBq)] for regional perfusion, and c) 18F-2-deoxyglucose [FDG; 6.5 mCi (241 MBq)] administered during a hyperinsulinemic-euglycemic clamp to assess viability.
16199320|NCT01400308|Drug|Mupirocin + Chlorhexidin|"Treatment after protocol described in the Consensus document and GEIH-SEIMC SEMPSPH Version 31/10/07. It is a protocol of 5 days (nasal mupirocin and chlorhexidine, potentially plus systemic antibiotics and 7 days)"
16199321|NCT01400308|Device|Prontoderm MRSA Kit|"Treatment after protocol established for Prontoderm® for five days and eventually plus systemic antibiotics.
~Prontoderm® is a Class III medical device"
16199322|NCT01400282|Device|High frequency spinal cord stimulation|
16199323|NCT01400269|Behavioral|Pacific Autism Center for Education (PACE ) developmentally based parent delivered intervention|Pacific Autism Center for Education (PACE ) developmentally based parent delivered intervention
16199324|NCT01400256|Drug|Valsartan|After the initial MRI, patients will be given a 160 mg dose of valsartan or placebo, in a double-blinded fashion. A sustained MAP reduction of 15-20% will be the goal. If the MAP remains within 15% of the initial value (prior to the first MRI scan) 24 hours after the first dose of valsartan (or placebo), the patients will be given a 320 mg dose of valsartan (or placebo) and will remain on valsartan 320 mg (or placebo) daily until day 7, or hospital discharge (whichever is sooner). If the MAP is falls by more than 20% after the 160 mg (or placebo) dose, the patient will be switched to 80 mg of valsartan (or placebo) until day 7, or hospital discharge (whichever is sooner). If the blood pressure is lowered by 15-20% (the goal), the patients will remain on valsartan 160 mg (or placebo) daily for the duration of the study.
16199325|NCT01400243|Drug|Nicotine|Nicotine patch 7mg
16199326|NCT01400243|Drug|Placebo Patch|Placebo patch
16199327|NCT01400230|Procedure|diagnostic procedures CCTA, CAG, IVUS and FFR|Diagnostic procedures including computed tomography, coronary angiography, intravascular ultrasound, fractional flow reserve were performed in the patients suspected ischemic heart disease.
16199328|NCT01400217|Drug|extra fine particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler|IPDI cohort intervention = initiation of intervention drug; IPDS cohort intervention = switching from baseline inhaled corticosteroid therapy to intervention drug without a change in baseline inhaled corticosteroid dose; IPDA cohort intervention = increase in baseline inhaled corticosteroid drug as intervention drug
16199329|NCT01400217|Drug|standard particle particle hydrofluoroalkane beclomethasone dipropionate via metered dose inhaler|IPDI cohort intervention = initiation of intervention drug; IPDS cohort intervention = switching from baseline inhaled corticosteroid therapy to intervention drug without a change in baseline inhaled corticosteroid dose; IPDA cohort intervention = increase in baseline inhaled corticosteroid drug as intervention drug
16199330|NCT01400191|Drug|Metformin|The study was designed as a randomized, cross-over trial with a washout period of at least 4 weeks between the phases. In both phases, the volunteers fasted for 42 h. This was done in order to include an evaluation of the pharmacodynamic effect of metformin on the glucose production in fasting healthy volunteers.
16199331|NCT01400165|Drug|Trazodone|each subject will be taken 1 tablet of Trazodone 150mg of each group (brand/generic)
16199332|NCT01400165|Drug|Quetiapine|each subject will be taken 1 tablet of Quetiapine 100mg of each group (brand/generic)
16200533|NCT01390571|Procedure|diffusion-weighted magnetic resonance imaging|
16199333|NCT01400165|Drug|Pindolol|each subject will be taken 1 tablet of Pindolol 10mg of each group (brand/generic)
16199334|NCT01400165|Procedure|Blood Collection|Blood Samples will be collected at a predefined time-frame to study the plasma level of each medication.
16199335|NCT01400152|Device|Additional active warming|Chemical heat pad applied to the upper torso
16199336|NCT01400139|Drug|Hydrocodone bitartrate q24h film-coated tablets|Hydrocodone bitartrate q24h film-coated tablets 20 - 120 mg once daily
16199337|NCT01400113|Drug|Asenapine|Asenapine Sublingual Tablet 10mg, single-dose
16199338|NCT01400113|Drug|Placebo|Placebo Sublingual Tablet, single-dose
16199339|NCT01400100|Drug|Intraarterial application of Octreotide|500 µg / 5 ml Octreotide is given as a single bolus injection in the gastroduodenal artery intraoperatively.
16199340|NCT01400100|Drug|sterile NaCl (sodium chloride) 0,9% solution|a single intraarterial shot of 5 ml saline solution in the gastroduodenal artery
16199341|NCT01400087|Device|Cap-attached Colonoscopy Versus Regular Colonoscopy|Trainees were divided into two group; Cap-attached Colonoscopy group or Regular Colonoscopy group. Trainees allocated to the former group undergo colonoscopy with cap for all cases, the latter without cap.
16199342|NCT01400074|Drug|Nilotinib, Imatinib|Nilotinib: 400 mg twice daily Imatinib: 400 mg twice daily
16199343|NCT01400048|Dietary Supplement|Aloe vera effervescent tablet (AVH200)|250 mg aloe vera and 60 mg ascorbic acid, Aloe Life®
16199344|NCT01400048|Dietary Supplement|Placebo control|60mg Ascorbic acid
16199345|NCT01400022|Other|UVA1 phototherapy|The UVA1-phototherapy is conducted 4 times per week over a period of 3 months. A UVA1-irradiation device of the company Sellamed, Gevelsberg (Germany) is used. The radiation intensity is 24 mW/cm ². The distance between radiation source and irradiation area is approximately 25 cm. Over five sessions, the UVA1 dose is increased slowly, starting with 10 J/cm ² in the first, 20 J/cm ² in the second and 30 J/cm ² in the third, 40 J/cm ² in the fourth, and from the fifth session 50 J/cm ². Additionally, a topical treatment with vaseline album once daily can be applied after irradiation (not before irradiation).
16199346|NCT01400022|Other|Cortisone|Clobetasol propionate (0.05%) in white vaseline is applied thinly once daily. The duration of treatment is 3 months.
16199347|NCT01400009|Drug|Vitamin D (Cholecalciferol )|10,000 IU tablets. 50,000 initial dose, followed by weekly doses of 10,000 IU
16199348|NCT01400009|Drug|Placebo|Standard Placebo made of Lactose 100 mg
16199349|NCT01399996|Dietary Supplement|Yogurt smoothie without probiotic|A daily 8 oz (240 mg) serving will provide 10x^y5 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12).
16199350|NCT01399996|Dietary Supplement|Yogurt smoothie with probiotic added post fermentation|A daily 8 oz (240 mg) serving will provide 10x^y5 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12).
16199351|NCT01399996|Dietary Supplement|Yogurt smoothie with probiotic added pre-fermentation|A daily 8 oz (240 mg) serving will provide 10x^y5 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12).
16199352|NCT01399996|Dietary Supplement|A capsule containing the probiotic|A capsule taken daily will provide between 10x^y9 and 10x^y10 cfu/ml of the probiotic (Bifidobacterium animalis subsp. lactis BB12).
16199353|NCT01399970|Other|Mobile Teleconsultation Arm (MTA)|"In addition to a face-to-face visit at baseline, patients will conduct mobile visits at home every two weeks. The general practitioner of choice will perform examinations, such as laboratory or occasionally pregnancy tests every 4 weeks according to the treatment guidelines."
16199354|NCT01399970|Other|Outpatient Consultation Arm (OCA)|Patients will receive routine outpatient care at the clinic according to the treatment guidelines, and will be scheduled for outpatient visits every 4 weeks.
16199355|NCT01399918|Drug|everolimus and bevacizumab|Cycle length will be defined as 28 days. Treatment will include everolimus 10mg, self administered orally once daily on a continuous schedule (days 1-28), and bevacizumab 10mg/kg, administered intravenously on days 1 and 15 of each cycle. Treatment will be continued until disease progression, major toxicity, or withdrawal from the study for any reason. Dose modification will be permitted based on toxicity. Patients that come off study before 6 months before documented progression/death will be treated as events for the 6 month PFS endpoint.
16199356|NCT01399905|Drug|carbidopa|75 mg of carbidopa per day versus 450 mg of carbidopa per day
16199357|NCT01399892|Dietary Supplement|soluble fiber in the form of benefiber|Benefiber, sugar free in an amount to total 20gms/1000kcal/day of fiber
16199358|NCT01399879|Other|Faraday cage, movement stabilization|The Faraday cage is a copper-mesh cage that surrounds the device and test site. It helps eliminate surrounding electrical noise. Movement stabilization will be achieved by placing a velcro strap over the arm to minimize random movements.
16199359|NCT01399866|Drug|D-cycloserine|2 single weekly doses, 50 mg capsule
16199360|NCT01399866|Drug|Placebo|
16199361|NCT01399853|Biological|160U /0.5ml EV71 Vaccine|inactivated vaccine (vero cell) against EV71 of 160U /0.5ml, two doses, 28 days interval
16199362|NCT01399853|Biological|320U /0.5ml EV71 vaccine|inactivated vaccine(vero cell) against EV71 of 320U /0.5ml, two doses, 28 days interval
16199363|NCT01399853|Biological|640U /0.5ml EV71 vaccine|inactivated vaccine (vero cell) against EV71 of 640U /0.5ml, two doses, 28 days interval
16199364|NCT01399853|Biological|(without adjuvant) 640U /0.5ml|inactivated vaccine (vero cell) against EV71 of (without adjuvant) 640U /0.5ml, two doses, 28 days interval
16199365|NCT01399853|Biological|0/0.5ml placebo|0/0.5ml placebo, two doses, 28 days interval
16199366|NCT01399840|Drug|BMN 673|Oral capsule with multiple dosage forms given once daily
16199367|NCT01399827|Drug|ADHD Medication|For those subjects not on stable ADHD treatment (defined as a stable, effective dose for at least one month, determined by the study clinician, of a medication that is FDA approved to treat ADHD), OROS-Methylphenidate will be openly prescribed. Subjects on a stable dose of medication for ADHD will be instructed to continue on their current dose of medication.
16199368|NCT01399827|Drug|Omega-3 Fatty Acids|Omega-3 Fatty Acids prescribed to participants randomized to active medication. They may be randomized to receive 1060mg of EPA (2 capsules containing 530mg EPA and 137mg DHA). Dosage will remain constant throughout study.
16199369|NCT01399814|Behavioral|perioperative fluid management|No preloading of epidural analgesia,7ml/kg lactated ringer's solution was administered in first hour,and 5ml/kg.h during the following hours,and 1000ml of glucose 5% was administered on the rest of the day during operation.1000~1500ml crystalloid was administered on the days following operation
16199370|NCT01399814|Behavioral|perioperative fluid treatment|500 mL HAES 6% was accepted as preloading of epidural analgesia,12ml/kg.h lactated ringer's solution was administered during the operation ,and 1000ml of glucose 5% was administered on the rest of the day during operation.2000~2500ml crystalloid was administered on the days following operation
16199371|NCT01399801|Procedure|Doppler flow measurement|use of doppler wire to measure change in flow that corresponds to changes in stroke volume to guide LV lead placement
16199372|NCT01399801|Procedure|standard implantation of the LV lead|Standard implantation of the LV lead with measurements of flow
16199373|NCT01399788|Drug|Myrin P Forte|Tablet containing Rifampicin, Isoniazid, Ethambutol and Pyrazinamide, given once daily, single dose
16199374|NCT01399788|Drug|Single drug references|containing Rifampicin, Isoniazid, Ethambutol and Pyrazinamide as single agents
16199375|NCT01399775|Procedure|immediate implantation|Immediately after tooth extraction, a dental implant is inserted
16199376|NCT01399775|Procedure|Delayed implantation|Four months after extraction, a dental implant is inserted and measurements are recorded.
16199377|NCT01399762|Device|mechanical recanalization|Endovascular thrombus extraction by mechanical recanalization devices
16199378|NCT01399749|Other|Implantation of autologous cells|Implantation of autologous ASC or chondrocytes, 1 million per cm² lesion, covered by autologous periosteal membrane
16199379|NCT01399736|Procedure|FFR-guided revascularisation strategy|FFR-guided revascularisation strategy
16199380|NCT01399736|Procedure|randomised to guidelines group|Staged revascularisation by proven ischemia or persistence of symptoms of angina
16199381|NCT01399723|Drug|Amoxicillin|Oral 45mg/kg 12 hourly
16199382|NCT01399723|Drug|Benzyl penicillin|Intravenous 50,000IU/kg 6 hourly
16199383|NCT01399710|Procedure|CT colonography|Participants were placed on a CT table and a small flexible rectal catheter was positioned. N-butyl-scopolamine was administered intravenously if this was common practice in the participating center. Immediately before scanning, pneumocolon was obtained through insufflation of room air or carbon dioxide, either manually by means of a balloon pump or with an automatic device, until maximum tolerance was reached. CT colonography was performed with the participant in supine and prone positions with the following scanning protocol: 120 kilovolt peak (kVp), 50 or fewer effective mA per second, and a section thickness not greater than 1.25 mm.
16199384|NCT01399710|Procedure|colonoscopy|Colonoscopy was performed at least 3 hours after CT colonography. The endoscope was advanced to the cecum and the entire length of the bowel was examined during endoscope withdrawal. The endoscopist was initially blinded to the result of CT colonography; at the end of each bowel segment evaluation, CT colonography results for that segment were disclosed (segmental unblinding). If a lesion measuring 6 mm or larger was detected at CT colonography but not at colonoscopy, the segment was reexamined to resolve the discrepancy
16199385|NCT01399710|Device|CT Colonography with computer assisted diagnosis (CAD),CADCOLON -im3D SpA., Torino Italy|Each CT colonography study was read in two phases. In the first phase the radiologist interpreted the examination without activating the CAD algorithm. This phase of reporting was defined as unassisted reading. Then the radiologist activated the CAD algorithm which pinpointed a series of colorectal lesion-like structures (i.e. lesion candidates) on both the prone and supine acquisition. All lesion candidates were examined. The second phase of reporting was defined as CAD-assisted reading.
16199386|NCT01399697|Drug|methotrexate|orally, Week 1 - 16
16199387|NCT01399697|Drug|methotrexate|orally, Week 17-28
16199388|NCT01399697|Drug|placebo|methotrexate placebo orally, Week 17-28
16199389|NCT01399697|Drug|tocilizumab [RoActemra/Actemra]|8 mg/kg iv every 4 weeks, 28 weeks
16199390|NCT01399684|Drug|5-Fluorouracil|Participants will receive 5-fluorouracil 400 milligrams per squared meter (mg/m^2) intravenous (IV) bolus and then 2400 mg/m^2 as a continuous IV infusion over 46-48 hours on Day 1 of every cycle until disease progression, unacceptable toxicity or at the maximum of 52 cycles, whichever occurs first.
16199391|NCT01399684|Drug|Bevacizumab|Participants will be administered bevacizumab at a dose of 5 milligrams per kilogram (mg/kg) every 14 days until disease progression or unacceptable toxicity, for a maximum of 52 cycles, whichever occurs first.
16199392|NCT01399684|Drug|Folinic acid|Participants will receive folinic acid 400 mg/m^2 IV infusion over 2 hours on Day 1 of every cycle until disease progression, unacceptable toxicity or at the maximum of 52 cycles, whichever occurs first.
16199393|NCT01399684|Drug|MEGF0444A|Participants will be administered MEGF0444A at a fixed dose of 400 milligrams (mg) IV on Day 1 of Cycle 1, followed by subsequent doses of 400 mg every 14 days until disease progression or unacceptable toxicity, for a maximum of 52 cycles, whichever occurs first.
16199394|NCT01399684|Drug|Oxaliplatin|Participants will receive oxaliplatin 85 mg/m^2 IV infusion over 90 minutes on Day 1 of every cycle for a maximum of 8 cycles.
16199395|NCT01399684|Drug|Placebo|Participants will be administered MEGF0444A matching placebo every 14 days until disease progression, unacceptable toxicity or at the maximum of 52 cycles, whichever occurs first.
16199396|NCT01399671|Other|vestibular stimulation|vestibular stimulation
16199397|NCT01399658|Procedure|Image-guided brachytherapy|MRI-guided application of brachytherapy
16199398|NCT01399658|Drug|3'-Deoxy-3'-18f-Fluorothymidine|Assessing tumor proliferation in Gynecologic cancer
16199399|NCT01399645|Drug|Liraglutide-metformin vs insulin-metformin|"Liraglutide (Victoza, Novo Nordisk) at a dose of 0.6 - 1.8 mg subcutaneous per day.
~Insulin glargine (Lantus, Sanofi-Aventis) with an initial bedtime starting dose of 10 IU."
16199400|NCT01399632|Behavioral|Low Fat and High Carbohydrate Diet|Low Fat and High Carbohydrate Diet
16199401|NCT01399632|Behavioral|High Fat and Low Carbohydrate Diet|High Fat and Low Carbohydrate Diet
16199402|NCT01399619|Drug|PegIFN/RBV|PegIFN/RBV for 24 or 48w
16199403|NCT01399619|Drug|PegIFN/RBV|PegIFN/RBV for 24 or 48w
16199404|NCT01399619|Drug|BI201335|BI201335 for 12w
16199405|NCT01399619|Drug|BI201335 24W|BI201335 for 24w
16199406|NCT01399619|Drug|PegIFN/RBV|PegIFN/RBV for 24 or 48w
16199407|NCT01399619|Drug|Bi 201335|BI 201335 for 24 w
16199408|NCT01399606|Drug|BF2.649|5,10,20,or 40 mg per day, in a once daily scheme
16199409|NCT01399593|Drug|Eculizumab|
16199410|NCT01399580|Drug|Atrasentan|Subjects will take two tablets daily of either low dose Atrasentan QD or high dose Atrasentan QD for 8 weeks during the treatment period.
16199411|NCT01399580|Drug|Placebo|Subjects will take two tablets daily of placebo QD for 8 weeks during the treatment period.
16199412|NCT01399567|Behavioral|Algorithm|The NH pain management algorithm is a series of decision-making tools that begin with regular, comprehensive pain assessment matched to residents' cognitive status and proceed through analgesic therapy appropriate to the character, severity, and pattern of pain.
16199413|NCT01399554|Behavioral|Motivational Enhancement Therapy plus Contingency Management|A combination of two motivational enhancement therapy (MET) sessions focused on increasing exercise spaced two months apart and four months of weekly contingency management (CM) for adhering to specific exercise activities. MET is a client-centered, directive method of enhancing intrinsic motivation to change by exploring and resolving ambivalence, and CM is a behavioral treatment offering individuals tangible reinforcers such as prizes for completion of specific target behaviors.
16199414|NCT01399515|Drug|Valproic Acid|One 500mg tablet by mouth daily
16199415|NCT01399502|Behavioral|Mood Memo emails|Participants will receive 12 emails over 6 weeks.
16199416|NCT01399489|Behavioral|Exercise training|Participants receive 16 weeks of moderate intensity aerobic training under the supervision of personal trainers. Each session lasts from 15 to 55 minutes depending upon patient tolerance
16199417|NCT01399476|Procedure|Endoscopic Myotomy|Patients will receive the surgical procedure described in the summary (POEM).
16199418|NCT01399476|Procedure|Endoscopic Myotomy for treatment of achalasia|Surgical procedure
16199419|NCT01399463|Device|Angioplasty performed via Paclitaxel Eluting Balloon catheter|
16199420|NCT01399463|Device|Angioplasty via DES|Angioplasty performed via commonly used Drug Eluting Stents
16199421|NCT01399450|Drug|paliperidone|paliperidone augmenting on ongoing medication
16199422|NCT01399424|Drug|CP|Immunization
16199423|NCT01399398|Procedure|Brain Scan-PET|
16199424|NCT01399398|Procedure|Brain Scan-MRI|
16199425|NCT01399398|Procedure|Arterial Line|
16199426|NCT01399398|Procedure|Venous Line|
16199427|NCT01399398|Procedure|Blood Sampling|
16199428|NCT01399385|Device|MR Imagining Techniques|"Group 1 will consist of subjects with a 10-year total CHD risk <10% (low)They will undergo a series of multiple small discovery studies in order to look at the multiple different MR methods of visualizing the coronary arteries
~Group 2 will consist of subjects with a 10-year total CHD risk 10-20% (intermediate)They will undergo a series of multiple small discovery studies in order to look at the multiple different MR methods of visualizing the coronary arteries
~Group 3 will consist of subjects with a 10- year total CHD risk 10-20% (intermediate)They will undergo a series of multiple small discovery studies in order to look at the multiple different MR methods of visualizing the coronary arteries
~Group 4 no known risk factors (control subjects)They will undergo a series of multiple small discovery studies in order to look at the multiple different MR methods of visualizing the coronary arteries"
16199429|NCT01399372|Biological|Rituximab|One 28-day cycle = 500 mg/m^2 intravenously on day 1 and day 5.
16199430|NCT01399372|Drug|Cytarabine|One 28-day cycle = 3 g/m^2 intravenously on day 1 and day 2.
16199431|NCT01399372|Drug|Methotrexate|One 28-day cycle = 3.5 g/m^2 intravenously (standard hydration/leucovorin support) on day 2.
16199432|NCT01399372|Drug|Procarbazine|One 28-day cycle = 100 mg/m^2 orally on days 2-8.
16199433|NCT01399372|Drug|Vincristine|One 28-day cycle = 1.4 mg/m^2 intravenously, dose capped at 2.4mg, on day 2 and day 16.
16199434|NCT01399372|Radiation|low-dose whole-brain radiation therapy|Total dose of 2340 cGy administered as 13 daily fractions of 180 cGy over 3 weeks. Participants with progressive disease on magnetic resonance imaging (MRI) do not receive WBRT.
16199435|NCT01399359|Behavioral|Counseling session|
16199436|NCT01399359|Other|Questionnaire 1|Questionnaire 1 assesses the recall and understanding of risk information given during the counseling session.
16199437|NCT01399359|Other|Questionnaire 2|Questionnaire 2 focuses on what factors, other thana the numerical risk-benefit analysis of SERM intake, are important in the decision-making process of women at increased risk for breast cancer.
16199438|NCT01399359|Other|online questionnaire|
16199439|NCT01399346|Drug|Insulin aspart|Application of 18 IU insulin aspart as one bolus at one injection site
16199440|NCT01399346|Drug|Insulin aspart|Application of 18 IU insulin aspart as 9 bolus of 2 IU each at nine injection sites
16199441|NCT01399333|Dietary Supplement|Group 1 Meal Replacement|4 weeks of utilizing Group 1 Meal Replacement 3-4 times daily, supplementing this protein product at each meal. As standard of care for the bariatric patient, they are required to get in 60-80 gms of protein daily
16199442|NCT01399333|Dietary Supplement|Group 2 Protein Supplement|4 weeks of utilizing Group 2 protein supplement 3-4 times daily, replacing this protein product at each meal. As standard of care for the bariatric patient, they are required to get in 60-80 gms of protein daily
16199443|NCT01399333|Dietary Supplement|Group 3|4 weeks of utilizing Group 3 protein supplement 3-4 times daily, replacing this protein product at each meal. As standard of care for the bariatric patient, they are required to get in 60-80 gms of protein daily
16199444|NCT01399320|Procedure|cyanoacrylate|excision of the sinus under local anesthesia the packing of the wound by cyanoacrylate dressing
16199445|NCT01399307|Procedure|Liposuction|Elective Liposuction
16199446|NCT01399268|Drug|Hydrocortisone|Prepared by pharmacy, 100 mg, IV, every 8 hours, 3 times
16199447|NCT01399268|Drug|Saline|Prepared by pharmacy same volume as study drug, IV, every 8 hours 3 times
16199448|NCT01399255|Biological|Insulin lispro|Dosage form- Subcutaneous Injection
16199449|NCT01399242|Drug|Certican|Patients' therapy will be replaced from tacrolimus-based to everolimus-based immunosuppression. Everolimus will be introduced on day 1 at dose of 2 mg/day (1mg bid), and then everolimus trough levels will be obtained from day 3 onwards until C0 reaches the target for three consecutive days. Through levels will be adjusted to achieve 6-10ng/ml. Thereafter, if the target level was reached, the measurement will be performed weekly for 4 weeks and every 2 weeks until 8 weeks after conversion.In parallel, the tacrolimus dose will be reduced by 50% on day 1 and another 25% on day 7. The Tacrolimus will be withdrawn on day 14 if the target levels of everolimus are obtained.EC-MPS will be unchanged until day 14 after conversion.
16199450|NCT01399216|Dietary Supplement|Supplement containing fucoidan, EPA, and DHA|75 mg fucoidan per day, for 8 weeks
16199451|NCT01399216|Dietary Supplement|Placebo|for 8 weeks
16200577|NCT01390324|Drug|Naratriptan|Tablets containing naratriptan 2,5 mg
16199452|NCT01399190|Biological|Bevacizumab|Bevacizumab administered according to prescribing information and normal clinical practice.
16199453|NCT01399190|Biological|Capecitabine|Capecitabine administered according to prescribing information and normal clinical practice.
16199454|NCT01399190|Drug|Oxaliplatin|Capecitabine administered according to prescribing information and normal clinical practice.
16199455|NCT01399164|Other|14C-B12 fortified bread|A single serving of 14C-B12 fortified bread
16199456|NCT01399151|Dietary Supplement|Vitamin D - Treatment 1|Volunteers will take a 400 IU/day dose of Vitamin D for 12 weeks.
16199457|NCT01399151|Dietary Supplement|Vitamin D - Treatment 2|Volunteers will take a 2,000 IU/day dose of Vitamin D for 12 weeks.
16199458|NCT01399151|Dietary Supplement|Vitamin D - Treatment 3|Volunteers will take a 5,000 IU/day dose of Vitamin D for 12 weeks.
16199459|NCT01399138|Dietary Supplement|Blueberry Powder|The groups will be randomized to receive 45g of blueberry powder or control (i.e., placebo) per day. Blueberry powder will be given as a smoothie to be consumed at the breakfast and dinner meals and an identical smoothie will be given as a control. The second smoothie will be consumed at least 6 hours from the first smoothie. The smoothies will be prepared in the metabolic kitchen and a week supply of frozen smoothies will be given to participants. Both the blueberry powder and control smoothie contain comparable energy and macronutrients
16199460|NCT01399125|Drug|Rivastigmine Patch|Once-daily target patch size 10 cm²
16199461|NCT01399125|Drug|Rivastigmine Capsules|Twice-daily target dose of 6 mg oral capsule
16199462|NCT01399125|Drug|Placebo to Rivastigmine patch|Matching placebo to Rivastigmine patch
16199463|NCT01399125|Drug|Placebo to Rivastigmine capsules|matching Placebo to Rivastigmine capsules
16199464|NCT01399112|Behavioral|Web-based computer program|Web-based computer programs will be used to help education people with a recent first episode of a mental illness learn about smoking. The programs are designed to help young smokers become motivated to being a smoking cessation program.
16199465|NCT01399099|Device|embrace device|Adhesive bandage/dressing intended to minimize scar formation.
16199466|NCT01399086|Drug|Fulvestrant|250mg on d1,15,29 or 250mg on d1 q28days
16199467|NCT01399073|Behavioral|virtual reality setup|testing for neglect in a virtual reality setup
16199468|NCT01399073|Behavioral|paper and pencil tests|testing for neglect with the classical paper-and-pencil tests
16199469|NCT01399073|Other|c-mri|structural and functional (resting state) imaging
16199470|NCT01399047|Drug|Mycophenolate mofetil|The liquid dosage will be individualized, contingent upon the subject's weight. Subjects will receive 50% of the target dose (300mg/m2/dose BID) during Week 0-Week 2, then increase to the full dose (600mg/m2/dose BID) in Week 3, continuing at this dose through Week 8. Additionally, due to the risk of gastrointestinal disturbance (hemorrhage, ulcer), children will also receive prophylactic Prilosec (Omeprazole) for the duration of the study, during both the mycophenolate and placebo arms.
16199471|NCT01399047|Drug|Liquid Placebo|The dosage will be individualized, contingent upon the subject's weight. Subjects will receive 50% of the target dose (300mg/m2/dose BID) during Week 0-Week 2, then increase to the full dose (600mg/m2/dose BID) in Week 3, continuing at this dose through Week 8. Additionally, due to the risk of gastrointestinal disturbance (hemorrhage, ulcer), children will also receive prophylactic Prilosec (omeprazole) for the duration of the study, during both the mycophenolate and placebo arms.
16199472|NCT01399021|Other|Early Drain Removal|Drain will be removed prior to patient's discharge on the day of the surgery
16199473|NCT01399021|Other|Late Drain Removal|Patient will be seen on the day following the surgery to have the drain removed
16199474|NCT01399008|Drug|Arhalofenate|Arhalofenate 400 and 600 mgs over-encapsulated tablets once daily for 4 weeks or Allopurinol 300 mg once daily for 4 weeks
16199475|NCT01399008|Drug|Allopurinol|Allopurinol 300 mg as active comparator
16199476|NCT01399008|Drug|Colchicine|0.6 mg colchicine daily as flare prophylaxis
16199477|NCT01399008|Drug|Placebo|Placebo
16199478|NCT01398995|Other|Reduction of basal insulin infusion to 50% of normal|Each participant in this cross-over trial will participate in the 4 arms of the trial. They will be presented with the four conditions in randomised order - reducing their basal insulin infusion rate to 50% of normal at the four time points specified. A comparison will be made between the conditions.
16199479|NCT01398982|Drug|Bupivacaine (study group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of 0.25% Bupivacaine will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of 0.25% Bupivacaine will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
16199480|NCT01398982|Drug|Isotonic saline (control group)|At the conclusion of the surgery, a 0.2 mL/kg bolus of Saline will be injected through each catheter in the OR. At midnight following the OR, 0.2mL/Kg of Saline will be injected through each catheter every 8 hours for the next 2 postoperative days by a MD member of the pain team. At 8am on postoperative day 3, the TAP catheters were removed by the pain team. Our rationale for decreasing the frequency of intermittent boluses from every 12 hours to 8 hours in this study design was based on our finding in the pilot study that patients frequently used more PCA between 8-12 hours following Bupivacaine bolus as the effect of the anaesthetic agent weaned off.
16199481|NCT01398969|Biological|Fresh FMT|Participants will receive fresh FMT (supernatant of fecal specimen mixed with water) on day 1. If cure is not reached at day 5 (+3) a repeat FMT will be performed
16199482|NCT01398969|Biological|Frozen-and-Thawed FMT|Participants will receive frozen-and-thawed FMT (supernatant of fecal specimen mixed with water) on day 1. If cure is not reached at day 5 (+3) a repeat FMT will be performed
16199483|NCT01398956|Drug|Levetiracetam|"formulation: tablet or dry syrup
~strength: 250 mg tablet, 500 mg tablet, dry syrup 50%
~dosage: Sb ≥16 years and ≥4 and <16 years (≥50 kg): 1000 mg/day, 2000 mg/day or 3000 mg/day; Sb ≥4 and <16 years (<50kg): 20 mg/kg/day, 40 mg/kg/day, or 60 mg/kg/day
~frequency: twice daily"
16199484|NCT01398943|Drug|Tetrahydrobiopterin (BH4)|single dose = 5 mg/kg
16199485|NCT01398943|Dietary Supplement|Antioxidant Cocktail|1g of vitamin C, 600 IU of vitamin E, and 600 mg of alpha-lipoic acid
16200578|NCT01390324|Drug|Naproxen|Tablets containing naproxen 500 mg
16199486|NCT01398930|Other|acupuncture|This is a 3-armed single-blinded randomized sham-controlled trial, comparing acupuncture along with pharmacological treatment, sham acupuncture including pharmacological treatment, and pharmacological treatment alone.
16199487|NCT01398917|Procedure|plastic endoprosthesis|one 10 Fr Plastic endoprosthesis or 2 7 Fr plastic endoprosthesis inserted through dominant stricture(s), to be extracted after 1-2 weeks
16199488|NCT01398917|Procedure|balloon dilatation|4 cm 6 mm biliary dilatation balloon to be inflated for 2 minutes in dominant stricture(s)
16199489|NCT01398891|Other|Positive Psychology Exercises|At each session, the interventionalist will prepare the subject to complete a randomly-selected positive psychology exercise, lasting approximately 20 minutes, within the next 24 hours. He or she will describe the rationale for the exercise and the details of the exercise, and will answer any questions. A sheet with written instructions (matching the verbal instructions) for the exercise will be provided, with space for recording the exercise and an area to provide ratings on the exercise. On the following day, the interventionalist will review the prior day's exercise (and record whether it was completed). The exercises will be completed daily on weekdays for a maximum of 8 days.
16199490|NCT01398878|Behavioral|Intervention work shift|Shiftwork schedule with elimination of shifts greater than 16 hours in length and at least 8 hours off between shifts for all residents in the Intensive Care Unit
16199491|NCT01398865|Procedure|PET scan and MRI scan|"PET: The PET Scan is manufactured by Siemens and the model is the Exact HR+ .rCMRglu data will be gathered over a 30 minute resting period using a Siemens HR+ PET camera (4.5 mm in-plane and axial resolution). The total time for an individual PET session, will thus be one hour and a half (30 minutes for serum pregnancy test and 30 minute uptake period followed by 30 minutes of scanning).
~MRI: High-resolution scans will be acquired using a Seimens (manufacturer) 1.5T Avonta system at MGH, to be coregistered with subsequently acquired PET images, and used for A) delineation of regions of interest (ROIs), and B) facilitation of optimal transformation to MNI space."
16199492|NCT01398852|Drug|Riboflavin|Riboflavin is a solution that will be delivered to the treatment area
16199493|NCT01398852|Device|VEGA UV-A Illumination System|This is a portable electronic device designed to deliver a dose of UV-A light to the treatment area
16199494|NCT01398839|Device|VEGA UV-A Illumination System|Only subjects assigned to the treatment group will receive treatment with the UV Light
16199495|NCT01398839|Drug|Riboflavin|Both treatment and sham groups will receive riboflavin
16199496|NCT01398787|Device|Lotrafilcon B contact lens with color|Plano (-0.00 diopter) silicone hydrogel contact lens in 1 of 4 colors: gray, blue, green, pure hazel
16199497|NCT01398787|Device|Phemfilcon A contact lens with color|Plano (-0.00 diopter) hydrogel contact lens in 1 of 4 colors: ColorBlends gray, Colorblends blue, Colorblends green, Colorblends pure hazel
16199498|NCT01398761|Other|Signout tool|Electronic signout tool
16199499|NCT01398748|Drug|Intranasal glutathione - (in)GSH|Intranasal glutathione-Tripeptide glutathione 100 mg/ml. 1 ml 3x per day TID X 12 weeks at 2100mg in 15 participants
16199500|NCT01398748|Drug|Intranasal glutathione - (in)GSH|Intranasal Glutathione-Tripeptide glutathione - 200mg/ml. 1 ml 3x per day TID X 12 weeks at 4200mg in 15 participants
16199501|NCT01398748|Drug|Saline Intranasal Delivery|Saline administration 1ml 3x/day 12 weeks in 15 participants
16199502|NCT01398722|Other|Intensive insulin therapy|Titration of the IV insulin rate for glucose goal 110-150 mg/dL
16199503|NCT01398722|Other|Conventional insulin therapy|Titration of the IV insulin rate for glucose goal 150-180 mg/dl
16199504|NCT01398709|Other|Slow rewarming strategy|Rewarming rate:0.24 degrees C/min.
16199505|NCT01398709|Other|Fast rewarming strategy|Rewarming rate:0.5 degrees C/min.
16199506|NCT01398696|Procedure|Patient Information Leaflets|Patient Information Leaflets (PIL) about adult gastroenteritis, children gastroenteritis, adult pharyngitis or either children pharyngitis in consultation room
16199507|NCT01398696|Procedure|usual consultation|No particular intervention during consultation for the Patient. No Information Leaflets (PIL) is given
16199508|NCT01398670|Biological|Insulin Lispro|"a. Lispro and Lispro Mix® 75/25 / Lispro Mix 50/50
~The drugs would be administered subcutaneously"
16199509|NCT01398670|Biological|Insulin Lispro|"Humalog® and Humalog® Mix75/25 /Humalog® Mix 50/50
~The drugs would be administered subcutaneously"
16199510|NCT01398657|Drug|Adjuvant Androgen-Deprivation Therapy|Short-term adjuvant androgen-deprivation therapy
16199511|NCT01398644|Other|Phlebotomy and erythrocytapheresis|Phlebotomy- removal of 500 ml whole blood Erythrocytapheresis- removal of 300-800 ml erythrocytes
16199512|NCT01398618|Drug|4-month rifampin vs. 9-month isoniazid|In the 4M-RMP group, enrolled subjects received 600 mg rifampin daily for 4 months. In the 9M-INH group, enrolled subjects received 300 mg isoniazid daily for 9 months.
16199513|NCT01398605|Other|Exercise training|Different dose of exercise training
16199514|NCT01398592|Drug|Vildagliptin|50mg vildagliptin bid
16199515|NCT01398592|Drug|Sitagliptin|100mg sitagliptin po qd
16199516|NCT01398579|Procedure|Gastroscopy|"20 patients will be randomized into two groups. All of them will be examined using four different endoscopy imaging technologies by one trained specialist. 10 patients will be in group A and another 10 patients will be in group B.
~Group A: WLE followed by AFI followed by NBI followed by pCLE. Group B: WLE followed by NBI followed by AFI followed by pCLE."
16199517|NCT01398566|Behavioral|SuperBetter play|average 10 min of game play per day for 6 week period
16199518|NCT01398553|Device|Armeo Spring|30min Armeo Spring + 15min task oriented therapy over 6 weeks Frequency: 3 x/week
16199519|NCT01398553|Other|conventional physiotherapy|30min occupational therapy(15min ADL-training, 15min repetitive training) + 15min task oriented therapy over 6 weeks Frequency: 3x/week
16199520|NCT01398540|Biological|IXIARO|2 immunizations (0,5ml) with a 28 day interval
16199521|NCT01398527|Other|Educ sessions & LTC Osteoporosis toolkit|Three points of contact to be made. The first being a 1-hour personal visit at each intervention LTC home from an osteoporosis expert with the homes professional or health advisory committee (PAC or HAC). The second and third contact points will be made through webinars between the osteoporosis expert and the group from the first meeting.
16199522|NCT01398514|Drug|Escitalopram|Escitalopram 10mg/day or matched pill placebo
16199523|NCT01398501|Drug|Sorafenib|Oral, 200 to 400 mg QD or BID
16199524|NCT01398488|Behavioral|Patient education|Patient education by health care professional compared to education via tablet PC
16199529|NCT01398436|Procedure|central venous catheter positioning in right atrium|A central venous catheter will be advanced for its entire length unless arrhythmias develop. Catheter position will be controlled by transesophageal echocardiography and/or by chest radiography
16199530|NCT01398423|Drug|Active Control|Losartan potassium (50 mg) plus placebo to match alpha lipoic acid (600 mg)
16199531|NCT01398423|Drug|INV-144|INV-144 is a combination drug product consisting of losartan potassium (50mg) and alpha lipoic acid (600 mg)
16199532|NCT01398410|Drug|Rabeprazole|Participants received rabeprazole 5 mg tablets and rabeprazole 10 mg matched placebo tablets orally, once daily
16199533|NCT01398410|Drug|Rabeprazole|Participants received rabeprazole 10 mg tablets and rabeprazole 5 mg matched placebo tablets orally, once daily
16199534|NCT01398384|Drug|Nitric Oxide|MI size at 48-72 hours
16199535|NCT01398384|Drug|MI size at 48-72 hours|Placebo gas
16199536|NCT01398371|Drug|Withdrawal of digoxin|Participants currently receiving digoxin for heart failure will have their digoxin stopped for 12 weeks.
16199537|NCT01398371|Drug|Digoxin|Stable digoxin therapy which produces a digoxin plasma level of 0.4-0.8.
16199538|NCT01398358|Behavioral|Parents of Preschoolers Series|"The POPS-Parent intervention consists of eight 60-90 minute lessons about preventing childhood obesity followed by four 10-minute reinforcing telephone contacts. Each lesson includes opportunities for parents to develop and practice skills, and a discussion of strategies to overcome challenges and problem-solving techniques, with an emphasis on building knowledge and self-efficacy.
~The POPS-Child Intervention uses children's stories with embedded healthy nutrition themes. Five lessons (6 books) are delivered over 12 weeks. Activities include classroom cooking experiences, games/activities associated with the story's nutrition themes, and goal setting. Family Links and Parent Pages are sent home to reinforce content from school to home."
16199539|NCT01398358|Behavioral|Incredible Years Series|"The Parent component (BASIC) is a group-based program (12-14 weeks, 2 hours/week) focused on enhancing parenting skills such as using effective praise, incentives, and limit-setting, and handling misbehavior. Parents complete homework activities that will be reviewed in group sessions and receive follow-up reinforcement phone calls.
~For the Child component (Dinosaur School), 60, 15-20 minute lessons are delivered during Circle Time in Head Start classrooms followed by small group activities. The curriculum focuses on teaching self-regulation skills, problem-solving strategies, and prosocial behaviors.
~Teachers are trained in classroom management strategies."
16199540|NCT01398345|Behavioral|Exercise and Respiratory Training|Patients in the interventional group will participate in an exercise program 7 days a week at low workloads (10 to 60 W) that will be supervised by physical therapists and physicians.
16199541|NCT01398332|Device|Stent graft (EXCLUDER)|Endovascular repair
16199542|NCT01398319|Behavioral|Group Brief Alcohol Intervention|Intervention includes identifying reasons for joining the military, roadblocks to successful completion of training, information about alcohol, two anonymous self-assessments, information on quantity-based alcohol consumption in order to reduce the risk of incidents.
16199543|NCT01398306|Other|Blood sampling by vena punction.|We obtain 10mL blood of the patients. The blood is obtained twice: once with angiogenesis inhibitors or mTOR inhibitors, and once without.
16199544|NCT01398293|Drug|danoprevir|100 mg single dose orally
16199545|NCT01398293|Drug|danoprevir|400 mg single dose orally
16199546|NCT01398293|Drug|danoprevir placebo|single oral dose
16199547|NCT01398293|Drug|moxifloxacin|400 mg single dose orally
16199548|NCT01398293|Drug|moxifloxacin placebo|single oral dose
16199549|NCT01398293|Drug|ritonavir|100 mg single dose orally
16199550|NCT01398293|Drug|ritonavir placebo|single oral dose
16199551|NCT01398280|Drug|Topical aminocaproic acid (ACA) mixed with Vanicream|25% Aminocaproic acid cream twice daily for up to 12 weeks.
16199552|NCT01398280|Drug|Vehicle cream|Vehicle cream moisturizer twice daily for up to 12 weeks
16199553|NCT01398267|Drug|aleglitazar|150 mcg orally daily, 4 weeks (Day 15 to Day 43)
16199554|NCT01398267|Drug|lisinopril|20 mg orally daily, 6 weeks (Day 1 to Day 43)
16199555|NCT01398267|Drug|placebo|aleglitazar matching placebo orally daily, 4 weeks (Day 15 to Day 43)
16199556|NCT01398254|Procedure|Primary Percutaneous Coronary Intervention (PPCI)|Participants will be randomly assigned an access site, radial or femoral, for PPCI.
16199557|NCT01398241|Drug|RO5267683|Multiple ascending doses
16199558|NCT01398241|Drug|placebo|Multiple ascending doses
16199559|NCT01398228|Behavioral|quality improvement initiatives|A six component quality improvement intervention will be implemented. These components include: establishment of a quality improvement team, hospital performance audit and feedback, implementation of a clinical pathway, training of physicians and nurses, online technical support and patient education.
16199560|NCT01398215|Procedure|transvaginal NOTES ventral hernia repair|ventral hernia repair via the transvaginal approach
16199561|NCT01398202|Dietary Supplement|vitamin D3|20 micrograms per day for 10 weeks
16199562|NCT01398202|Dietary Supplement|25-hydroxyvitamin D3|7 microgram/day for 10 weeks
16199563|NCT01398202|Dietary Supplement|25-hydroxyvitamin D (20 microgram/day)|20 microgramday for 10 weeks
16199564|NCT01398202|Dietary Supplement|Placebo|0 ug vitamin D3/25-hydroxyvitamin D3/day for 10 weeks
16199565|NCT01398189|Drug|clozapine|C-11 clozapine
16199566|NCT01398176|Dietary Supplement|3 ounces of mushrooms|3 ounces of mushrooms consumed daily for 4 weeks
16199567|NCT01398176|Dietary Supplement|6 ounces of mushrooms|6 ounces of mushrooms consumed daily for 4 weeks
16199568|NCT01398163|Other|1-Fermented Dairy Product (test)|Arm 1 - Intervention 1 (probiotics)
16199569|NCT01398163|Other|2-Milk-based non-fermented dairy product(control)|Arm 2 - Intervention 2 (control)
16199570|NCT01398150|Dietary Supplement|Beverage made to look like the cranberry beverage|one 15 ounce bottle of beverage consumed daily
16199571|NCT01398150|Dietary Supplement|Beverage made from cranberry compounds|one 15 ounce bottle consumed daily for 70 days
16199572|NCT01398124|Biological|Cyclin B1 Peptide|vaccine
16200579|NCT01390311|Drug|Azacitidine|
16199579|NCT01398072|Drug|Moxifloxacin|An oral dose of 400 mg once daily for 5 consecutive days every 4 weeks.
16199580|NCT01398072|Drug|Azithromycin|An oral dose of 250 mg once daily three times a week (every other day).
16199581|NCT01398072|Drug|Doxycycline|An oral dose of 100 mg once daily.
16199582|NCT01398072|Drug|Placebo|Oral dose of one table once daily.
16199583|NCT01398059|Other|Sedentary|In this condition, participants will engage in 8 hours of uninterrupted sedentary behaviour.
16199584|NCT01398059|Other|Sedentary With Breaks|In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak.
16199585|NCT01398059|Other|Sedentary With Breaks and Physical Activity|In this condition participants will engage in 8 hours of sitting, although the sitting will be interrupted every 20 minutes. During these interruptions participants will spend 2 minutes walking at an intensity equivalent to 30% of VO2peak. Participants will also engage in 20 minutes of structured physical activity at an intensity of 60% of VO2peak in both the morning and afternoon.
16199586|NCT01398046|Drug|Dasatinib|dasatinib (100mg) PO x1
16199587|NCT01398046|Drug|Dasatinib plus Rabeprazole|Rabeprazole (20mg) PO twice daily (Days 1-3); Dasatinib (100mg) PO x1 (Day 4)
16199588|NCT01398046|Drug|Dasatinib plus Rabeprazole AND Betaine Hydrochloride|Rabeprazole (20mg) PO twice daily (Days 1-3); Betaine Hydrochloride (1500mg) PO x1 AND Dasatinib (100mg) PO x1 on Day 4
16199589|NCT01398033|Device|paclitaxel-coated balloon|Balloon is coated with paclitaxel in a concentration of 3µg/mm2.
16199590|NCT01398033|Device|non-coated balloon|percutaneous transluminal angioplasty with a non-coated balloon
16199591|NCT01398020|Drug|Standard Bowel Prep|Subjects will be asked to take 4L of Peglyte the day prior to procedure.
16199592|NCT01398020|Drug|2L Bi-Peglyte Bowel Prep|Subjects will be asked to take 2L Bi-Peglyte and 15mg bisacodyl the day prior to procedure.
16199593|NCT01398007|Procedure|Camouflage syringe|Dental anesthesia is administered using the camouflaged syringe.
16199594|NCT01397994|Drug|Nicorandil|Patients would be advised 10mg bd nicorandil for the first seven days. Drug will be titrated to 20 mg bd after one week, atenolol 50 mg will be given along with nicorandil from day 1
16199595|NCT01397994|Drug|Atenolol|Patients in the control arm would be advised atenolol 50 mg od
16199596|NCT01397981|Behavioral|Gait retraining|Changing the kinematics of walking
16199597|NCT01397968|Drug|YKP3089|Capsule, dose to be titrated Tablet, dose to be titrated
16199598|NCT01397968|Drug|Placebo|Placebo capsule Placebo tablet
16199599|NCT01397955|Drug|E2 transdermal (Julina, BAY86-5435)|Patients in daily life treatment receiving Julina for postmenopausal osteoporosis
16199600|NCT01397942|Other|Diet intervention|The participants in the two experimental arms will each have to consume 500 g of vegetables and cabbages daily.
16199601|NCT01397929|Drug|BAL101553|Intravenous administration
16199602|NCT01397890|Drug|Budesonide/formoterol (Symbicort® Turbuhaler®)|Budesonide/formoterol (Symbicort® Turbuhaler®) 160/4.5μg/inhalation, 2 inhalations twice daily
16199603|NCT01397890|Drug|Tiotropium (SpirivaTM)|Tiotropium (SpirivaTM) 18 μg/inhalation, 1 inhalation once daily
16199604|NCT01397877|Drug|BKM120|per os, 60mg/j, until progression or unacceptable toxicity
16199605|NCT01397864|Drug|rhC1INH or pdC1INH|C1 inhibitor, either plasma-derived (pdC1INH) or the recombinant human form (Ruconest)
16199606|NCT01397851|Device|Insecticide-treated net (BASF Incerceptor)|One per farmer, once during the 2010-2011 season
16199607|NCT01397838|Drug|Pro-Bone|500 mg Capsules of Pro-Bone twice daily
16199608|NCT01397825|Drug|Alisertib (MLN8237)|Alisertib (MLN8237) enteric coated tablet (ECT).
16199609|NCT01397825|Drug|Rituximab|Rituximab IV infusion.
16199610|NCT01397825|Drug|Vincristine|Vincristine IV Infusion.
16199611|NCT01397812|Device|BreathScanner 1.0|For the HeartsBreath test, breath is collected using BreathScanner 1.0 and sent to central laboratory for analysis for markers of transplant rejection.
16199612|NCT01397812|Device|BreathLink|The BreathLink point-of-care system detects and quantifies the breath VOC's determined to be biomarkers during the development of the Heartsbreath test.
16199613|NCT01397799|Drug|KX2-391|Oral dose solution, once-daily dosing for 28-days. Subjects may continue beyond the first 28-days until disease progression or unacceptable toxicity develops.
16199614|NCT01397786|Drug|OPC-34712|"Phase A: 1-2 mgs/day by mouth, max of 4 wks.
~Phase B: 1-4 mgs/day by mouth, up to 52 weeks"
16199615|NCT01397734|Drug|Arsenic trioxide|0.15mg/kg/day Arsenic trioxide given IV on days 1-5 of the cycle.
16199616|NCT01397708|Biological|INXN-2001|"approximately 1.0 x 1012 viral particles (vp) per injection
~one intratumoral injection of INXN-2001 per study cycle
~maximum of 6 study cycles"
16199617|NCT01397708|Drug|INXN-1001|"4 dose cohorts (5mg/day, 20mg/day, 100mg/day, and 160mg/day)
~7 oral daily doses of INXN-1001 per study cycle
~maximum of 6 study cycles
~1 Expansion cohort at a single dose level at or below MTD (160mg/day)"
16199618|NCT01397695|Drug|Bevacizumab|The bevacizumab will then be sprayed by the treating physician in the clinic, under direct observation. Spray will be achieved by administering the bevacizumab through a mucosal atomization device. 0.1cc will be sprayed into both nares. Patients will then sit for 5 minutes, the application will be repeated for a total of 40 applications, thereby administering 50mgs into each nostril, a total of 100mgs into each patient. The 5 minute spacing has been arbitrarily chosen as sufficient time for 0.1cc of solution to be absorbed by the nasal mucosa. That will complete the treatment.
16199619|NCT01397682|Other|blood sample collection|A blood sample will be drawn within 24 hours from admission for determination of biomarkers and genetic analyses
16199620|NCT01397669|Procedure|Colon biopsy, lymph node biopsy, lumbar puncture|Eligible subjects will undergo a flexible sigmoidoscopy and biopsy, lumbar puncture, lymph node biopsy at Chulalongkorn University Hospital.
16199621|NCT01397656|Procedure|CPR using 30:2 ratio|Participants will begin performing CPR using a ratio of 30 compressions to 2 ventilations. Participants will then cross over to the other intervention and use continuous compressions.
16199622|NCT01397656|Procedure|CPR using continuous compressions|Participants will begin performing CPR using continuous chest compressions. Participants will then cross-over to the other intervention arm and perform CPR using a ratio of 30 compressions to 2 ventilations.
16200870|NCT01387958|Drug|LCQ908|
16199623|NCT01397643|Other|Non-operative|Patients in the non-operative arm will be managed conservatively using a sling, or an above elbow lightweight cast if problems with pain, for 10-14 days post injury. Patients will then be allowed to mobilise as able.
16199624|NCT01397643|Other|Operative|For those patients in the operative group, tension band wire of plate fixation will be employed depending on the choice of their supervising consultant. Following surgery, the post-operative assessment and course will be as per normal protocol for patients who are not in this study. Patients in the operative group will be immobilised depending on fracture fixation during surgery and the decision will be made by the treating surgeon. Physiotherapy will be arranged when required.
16199625|NCT01397630|Drug|Oxytocin|Accelerated Oxytocin Titration
16199626|NCT01397617|Device|NobelActive Internal implant|Dental implant
16199627|NCT01397617|Device|NobelActive External implant|Dental implant
16199628|NCT01397617|Device|NobelReplace Tapered Groovy implant|Dental implant
16199629|NCT01397604|Drug|GLA-AF|GLA-AF contains GLA, a new synthetic lipid A molecule that combines 6 acyl chains with a single phosphorylation site. GLA-AF contains GLA in an aqueous solution. One 2 mcg injection will be given per patient in the upper arm, each randomized to either subcutaneous or intramuscular routes.
16199630|NCT01397604|Drug|GLA-SE|GLA-SE contains GLA, a new synthetic lipid A molecule that combines 6 acyl chains with a single phosphorylation site. GLA-SE contains GLA in a squalene oil emulsion. One 2 mcg injection will be given per patient in the upper arm, each randomized to either subcutaneous or intramuscular routes.
16199631|NCT01397604|Other|Squalene|Squalene is a natural organic compound obtained from shark liver oil. In this study, it is used to solubilize GLA in the GLA-SE formulation. Patients randomized to receive the squalene will be given one 2mcg injection of the squalene oil in the upper arm, each patient randomized further to either subcutaneous or intramuscular routes.
16199632|NCT01397591|Biological|Ofatumumab|Given intravenously
16199633|NCT01397591|Drug|Bortezomib|Given intravenously
16199634|NCT01397578|Drug|MABT5102A|Repeating subcutaneous injection
16199635|NCT01397578|Drug|MABT5102A|Repeating intravenous infusion
16199636|NCT01397578|Drug|placebo|Repeating subcutaneous injection
16199637|NCT01397578|Drug|placebo|Repeating intravenous infusion
16199638|NCT01397565|Procedure|Laparoscopic cholecystectomy|Laparoscopic cholecystectomy
16199639|NCT01397565|Procedure|Minilaparoscopic cholecystectomy|Laparoscopic cholecystectomy performed using minilaparoscopic instruments
16199640|NCT01397552|Drug|Dexamethasone|10 mg/mL injected into lumbar spine, one level, one injection
16199641|NCT01397552|Drug|methylprednisolone acetate|80 mg of methylprednisolone acetate will be given in the lumbar spine, one level, one time
16199642|NCT01397539|Drug|BIIB037|Participants receive a single dose of BIIB037 by intravenous (IV) infusion in cohorts assigned to the following ascending doses: .03 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg, 30 mg/kg, and 60 mg/kg.
16199643|NCT01397539|Other|Placebo|Participants receive a single dose of matching BIIB037 placebo by intravenous (IV) infusion.
16199644|NCT01397513|Drug|Aspirin|Tablets, 75 or 320mg once daily for 4 weeks. A 4-week wash-out period separated the two treatment periods.
16199645|NCT01397500|Drug|Genotropin|Genotropin administered sc once a day by patient or caregiver.
16199646|NCT01397500|Drug|Testosterone undecannoate|Testosterone undecannoate administered twice (6 week Interval) im by investigator.
16199647|NCT01397487|Procedure|Blastomere biopsy|The blastomere biopsy will be done after 72 hours of embryo culture. An inverted microscope Olympus IX70 with a heated stage will be used to perform the biopsy. The micromanipulation for the blastomere extraction will be made with a micropipette MBB-FP-M-30 (Humagen).
16199648|NCT01397474|Other|PPTFM|Peripheral Perfusion Targeted Fluid Management
16199649|NCT01397461|Drug|ozenoxacin placebo|cream
16199650|NCT01397461|Drug|retapamulin 1% ointment|ointment
16199651|NCT01397461|Drug|ozenoxacin 1% cream|1% cream
16199652|NCT01397448|Drug|E3810|E3810 5 mg/day Group: Orally administered E3810 5 mg tablets and E3810 10 mg placebo tablets once daily after breakfast; and orally administered Teprenone 50 mg placebo capsules three times daily after each meal.
16199653|NCT01397448|Drug|E3810|E3810 10 mg Group: Orally administered E3810 5 mg placebo tablets and 10 mg tablets once daily after breakfast; and orally administered Teprenone 50 mg placebo capsules three times daily after each meal.
16199654|NCT01397448|Drug|Teprenone|Teprenone 150 mg/day Group: Orally administered E3810 5 mg placebo tablets and 10 mg placebo tablets once daily after breakfast; and orally administered Teprenone 50 mg capsules three times daily after each meal.
16199655|NCT01397422|Drug|ADS-5102 (extended release amantadine HCl)|Oral capsules to be administered once daily at bedtime, for 8 weeks
16199656|NCT01397409|Drug|AGN-150998|AGN-150998 Intravitreal injection.
16199657|NCT01397409|Drug|ranibizumab|Ranibizumab 0.5 mg given by intravitreal injection.
16199658|NCT01397409|Other|Sham Injection|Stage 3: Sham injection at Weeks 12 and 16.
16199659|NCT01397396|Procedure|Inspiratory Muscle Training|Three times daily inspiratory muscle training (2x30 breaths) at an intensity of >50% Pi,max
16199660|NCT01397370|Drug|GLPG0492|Oral solution
16199661|NCT01397370|Drug|Placebo|Oral solution
16199662|NCT01397357|Other|Cardiac magnetic resonance - CINE MRI stress test.|Cardiac magnetic resonance - dipyridamole or dobutamine MRI stress test.
16199663|NCT01397331|Drug|Isoflurane|Anesthesia based on inhalation of 1-1.5 Minimal Alveolar Concentration of Isoflurane with the addition of infusion of remifentanil
16199664|NCT01397331|Drug|Propofol|Anesthesia based on the infusion of 2-5 mg/kg/h of propofol with the addition of infusion of remifentanil
16199665|NCT01397305|Drug|[6R] 5,10-methylenetetrahydrofolate (arfolitixorin)|10, 50, 100, 200, and 500 mg/m2 IV on day 1, day 8 day and day 15 of each 21-day cycle. 3 cycles.
16199666|NCT01397305|Drug|Pemetrexed|500 mg/m2 IV on day 1 of each 21-day cycle. 3 cycles.
16199667|NCT01397279|Biological|intravenous glucose tolerance test|Administration of a 30% weight-adapted glucose bolus intravenously.
16199668|NCT01397279|Biological|hyperinsulinemic euglycemic clamp|Intravenous administration of 20% glucose and insulin over 3 hours
16199669|NCT01397266|Procedure|Transcranial Magnetic Stimulation|ACTIVE rTMS delivered to the left dorsolateral prefrontal cortex
16199670|NCT01397266|Procedure|Placebo TMS|PLACEBO rTMS delivered to the left dorsolateral prefrontal cortex
16199671|NCT01397253|Other|Automated communication tools|"Automated communication tools will include:
~PCP notification of patient admission and location
~Data on medications begun on admission
~Automated alerts on changes in patient status and location while the patient is hospitalized
~Links to the EMR and to hospital physician contact information on all email alerts
~Real-time delivery of discharge information (medications, instructions, and follow-up) to the PCP
~Automatic reporting to PCPs of test results pending at discharge
~Electronic delivery of final discharge summaries"
16199672|NCT01397240|Drug|Albis Tab|2 Tab, twice a day, 12 weeks
16199673|NCT01397240|Drug|Placebo|2 Tab, twice a day, 12 weeks
16199674|NCT01397227|Biological|Ad35.CS.01/Ad26.CS.01 low dose (1 x 10^10 vp)|Prime-boost schedule: Each subject receives two injections of Ad35.CS.01 (on Days 0 and 28) followed by one injection of Ad26.CS.01 (on either Day 55 or 59).
16199675|NCT01397227|Biological|Ad 35.CS.01/Ad 26.CS.01 high dose (5 x 10^10 vp)|Prime-boost schedule: Each subject receives two injections of Ad35.CS.01 (on Days 0 and 28) followed by one injection of Ad26.CS.01 (on either Day 55 or 59).
16199676|NCT01397227|Biological|Placebo|Each placebo subject receives in total three injections of placebo: Day 0, Day 28, and either Day 55 or 59
16199677|NCT01397214|Drug|Megace F|Megace F oral suspension
16199678|NCT01397214|Drug|Megace OS|Megace oral suspension
16199679|NCT01397201|Drug|Placebo|2 puffs b.i.d. placebo HFA MDI
16199680|NCT01397201|Drug|BI 54903|2 puffs b.i.d. BI54903 medium range via Respimat inhaler
16199681|NCT01397201|Drug|Placebo|2 puffs b.i.d. placebo BI54903
16199682|NCT01397201|Drug|Placebo|2 puffs b.i.d. placebo HFA MDI
16199683|NCT01397201|Drug|Fluticasone|2 puffs b.i.d. 110mcg Fluticasone propionate HFA MDI
16199684|NCT01397201|Drug|BI 54903|2 puffs BI54903 via Respimat inhaler
16199685|NCT01397201|Drug|BI 54903|2 puffs b.i.d. BI54903 via Respimat inhaler
16199686|NCT01397201|Drug|Placebo|2 puffs placebo BI54903 via Respimat inhaler
16199687|NCT01397201|Drug|Placebo|2 puffs b.i.d. placebo HFA MDI
16199688|NCT01397201|Drug|Placebo|2 puffs b.i.d. placebo HFA MDI
16199689|NCT01397188|Device|PiCCO|transpulmonary thermodilution technique
16199690|NCT01397188|Other|sham, no intervention|no intervention
16199691|NCT01397175|Device|Biolimus-eluting stent|Biolimus-eluting stent (BES, BioMatrix or BioMatrix Flex, Biosensors, USA) has bio-degradable polymer which is consisted with poly-lactic acid (PLA) and degraded into H2O and CO2 while releasing the biolimus. BES would be expected to reduce the stent thrombosis comparing with the DES with durable polymer.
16199692|NCT01397175|Device|Everolimus-eluting stent|Everolimus-eluting stent (EES, Xience V or Xience Prime, Abbott, USA) use the MULTILINK VISION stent platform and durable polymer containing everolimus. It has the thinnest strut thickness among the available DES in Korea.
16199693|NCT01397175|Device|Zotarolimus-eluting stent|Zotarolimus-eluting stent with biolinx polymer (ZES, Endeavor Resolute or Endeavor Resolute Intergrity, Medtronic, USA) has DRIVER stent platform. The durable polymer in this DES has changed from phosphorylcholine (PC) polymer which was used in Endeavor to Biolinx polymer which has more biocompatible features.
16199694|NCT01397162|Drug|Fluticasone propionate|2 puffs b.i.d. via HFA MDI matching placebo inhaler
16199695|NCT01397162|Drug|Placebo|2 puffs b.i.d. via HFA MDI matching placebo inhaler
16199696|NCT01397162|Drug|Placebo|2 puffs b.i.d. via HFA MDI matching placebo inhaler
16199697|NCT01397162|Drug|BI 54903|2 puffs b.i.d. via Respimat inhaler
16199698|NCT01397162|Drug|BI 54903|2 puffs b.i.d. via Respimat inhaler
16199699|NCT01397162|Drug|Placebo|2 puffs b.i.d. via placebo Respimat inhaler
16199700|NCT01397162|Drug|Placebo|2 puffs b.i.d. via placebo Respimat inhaler
16199701|NCT01397162|Drug|Placebo|2 puffs b.i.d. via HFA MDI matching placebo inhaler
16199702|NCT01397162|Drug|Placebo|2 puffs b.i.d. via HFA MDI matching placebo inhaler
16199703|NCT01397162|Drug|BI 54903|2 puffs b.i.d. via Respimat inhaler
16199704|NCT01397149|Drug|Placebo|Dosage form, frequency and duration exactly as experimental arm.
16199705|NCT01397149|Drug|Eltrombopag|"Phase I:
~Single arm dose-escalation trial part, to test 4 doses of eltrombopag (75mg, 150mg, 225mg, 300mg) to find the appropriate, feasible dose to achieve a durable increase in platelet count (≥100,000/µl). Eltrombopag will be administered once daily at the respective dose level for 2 weeks (unless platelet counts rise to > 400,000/µl).
~Phase II:
~Patients will be randomized (2:1 eltrombopag : placebo) to explore the efficacy and confirm the safety of the identified dose level from Phase I. Eltrombopag/placebo will be administered before starting each cycle (and possibly following chemotherapy treatment depending on data from phase I), and will continue during all cycles of treatment until subjects finish chemotherapy (alkylating agents and/or purine analogue-based therapy). The schedule and days of eltrombopag dosing in Phase II will be determined based on data analyzed from Phase I."
16199706|NCT01397123|Other|Training teachers on healthier lifestyles|During 2007/2008 seven out of eighty public elementary public schools from Guimarães (Portugal) were invited to participate in this study. The number of schools involved was according to constraints of personnel for the assessment and intervention. Schools were the unit of randomization and three were assigned into intervention, and four into control group. Data was collected prior to intervention and immediately after, during the year 2009 (post-intervention). Prior to participation on data collection, parents provided informed consent, and children provided oral assent.
16199707|NCT01397110|Other|respiratory and exercise therapy|Conventional therapy with specific respiratory and physical therapy plus mental walking training
16199708|NCT01397097|Drug|LNG-IUS (BAY 86-5028)|LCS12 insertion will occur at randomization visit (Visit 2). Duration of study treatment is 12 months with an follow-up extension for up to 3 years
16199709|NCT01397097|Drug|68 mg etonorgestrel implant for subdermal use (Nexplanon)|Implant insertion will occur at randomization visit (Visit 2). Duration of study treatment is 12 months, may be continued up to 3 years under standard care.
16199710|NCT01397084|Drug|esomeprazole 20 mg|esomeprazole 20 mg once daily for 8 weeks
16199711|NCT01397071|Other|Avocado|Fresh Avocado
16199712|NCT01397045|Other|VATS|Video-assisted lung segmentectomy
16199713|NCT01397045|Procedure|Mini thoracotomy|Mini muscle sparing thoracotomy for lung segmentectomy
16199866|NCT01395901|Drug|Palonosetron|Single dose Palonosetron IV 1 mcg/kg (up to a maximum total dose of 0.075 mg)
16200871|NCT01387958|Drug|Placebo|
16199714|NCT01397032|Behavioral|Attention Bias Modification Treatment (ABMT)|Behavioral: Attention Bias Modification Treatment (ABMT) Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns.
16199715|NCT01397032|Behavioral|Attention Control Condition|Attention training using a computerized spatial attention task (dot-probe) not intended to alter threat-related attention patterns.
16199716|NCT01397019|Drug|Oxaliplatin, irinotecan, 5-FU & leucovorin|FOLFIRINOX followed by 50 gy/27 F in combination with capecitabine in patients with borderline resectable tumors
16199717|NCT01397006|Drug|Pregabalin|Pregabalin dose escalating every 2 weeks. Starting dose is 75 mg. Titrated up to maximum of 450mg
16199718|NCT01396993|Procedure|Breast Surgery|breast conserving surgery AND immediate defect filling using local flaps (level I) or reduction plastics (level II) as well as mastectomy and immediate reconstruction using free flaps
16199719|NCT01396993|Procedure|Breast Surgery|Breast conserving therapy without defect correction
16199720|NCT01396967|Device|surgery|cataract surgery
16199721|NCT01396941|Behavioral|Sleep restriction|Sleep restriction will consist of 5 nights, sleeping 4 hours per night Normal sleep will consist of 5 nights, sleeping 9 hours per night
16199722|NCT01396928|Procedure|Colonic reservoir|Type of reservoir to be performed
16199723|NCT01396915|Dietary Supplement|Dietary Protein Intake|Dietary Protein Intake This is a 12-week randomized,prospective study incorporating a dietary intervention in which subjects will consume either higher protein(HP:1.4g protein•kg-1•d-1) or normal protein diet (NP:.8g protein•kg-1•d-1)
16199724|NCT01396902|Behavioral|Standard of care|You will receive an immunization handout and verbal instructions regarding your child's next apt. Your child's immuniztion records will also be checked through KSWebIZ an internet based system that tracks immunizations for kids in Kansas.
16199725|NCT01396902|Behavioral|Text Messaging|You will receive text message reminders prior to your child's two, four and six month immunization due dates. You will be asked to take part in a phone interview and your child's immuniztion records will be checked through KSWebIZ an internet based system that tracks immunizations for kids in Kansas.
16199726|NCT01396889|Drug|Echinacea|0.5ml daily for children 1-2 years old and 2ml daily for children 2-5 years old
16199727|NCT01396889|Drug|Placebo|Placebo (0.5ml daily for children 1-2 years old and 2ml daily for children 2-5 years old) for 3 months
16199728|NCT01396876|Behavioral|clown|a distraction technique is performed by a clown during venipuncture
16199729|NCT01396863|Procedure|HDF during the first examination|"The patient will receive treatment with pre-dilution hemodiafiltration during the first examination.
~During the second examination the patient will receive treatment with low flux hemodialysis.
~MRI of the brain will be performed before and after the treatment. The MRI-data will later be processed to determine the degree of brain volume change due to the treatment."
16199730|NCT01396863|Procedure|HD during the first examination|"The patient will receive treatment with low flux hemodialysis during the first examination.
~During the second examination the patient will receive treatment with pre-dilution hemodiafiltration.
~MRI of the brain will be performed before and after the treatment. The MRI-data will later be processed to determine the degree of brain volume change due to the treatment."
16199731|NCT01396837|Device|RedDress Wound Care System (RD1)|Weekly application. A blood based wound care treatment
16199732|NCT01396824|Other|No intervention|No intervention
16199733|NCT01396811|Drug|33525|Daily for 14 days
16199734|NCT01396811|Drug|Placebo|Daily for 14 days
16199735|NCT01396785|Drug|33525|Daily for 14 days
16199736|NCT01396785|Drug|Placebo|Daily for 14 days
16199737|NCT01396772|Behavioral|PREPARE education program|"PREPARE stands for Prediabetes Research and Education Promoting Activity and Responsible Eating and is a 6-month community-based prediabetes lifestyle and behaviour change intervention program. It includes a series of six interactive education sessions of two hours each on healthy eating and physical activity."
16199738|NCT01396772|Other|standard of care presentation|A one-time 2-hour group prediabetes education session, offered as the standard for individuals referred for prediabetes in London, Ontario (Canada)
16199739|NCT01396759|Procedure|Bubble continuous positive airway pressure|All children will be monitored for by pulse oximetry for arterial O2 saturation, respiratory rate, lower chest wall in-drawing, intercostal retraction, head nodding, cyanosis, tracheal tug, heart failure (defined by the presence of tachypnea, tachycardia, gallop rhythm, hepatomegaly, pedal oedema, basal crackles). Arterial or capillary blood gas analyses will be done for children failing to maintain saturation (>90% with allocated treatment), or if there is concern about hypercarbia or acidosis.
16199740|NCT01396759|Procedure|Humidified high flow air / O2 mix at 2 l/kg/min|Humidified high flow air / O2 mix at 2 l/kg/min through nasal canula. All children will be monitored for by pulse oximetry for arterial O2 saturation, respiratory rate, lower chest wall in-drawing, intercostal retraction, head nodding, cyanosis, tracheal tug, heart failure (defined by the presence of tachypnea, tachycardia, gallop rhythm, hepatomegaly, pedal oedema, basal crackles). Arterial or capillary blood gas analyses will be done for children failing to maintain saturation (>90% with allocated treatment), or if there is concern about hypercarbia or acidosis.
16199741|NCT01396759|Procedure|Standard O2 supplementation by nasal cannula at 0.5 - 2 l/min|Standard O2 supplementation will be given by nasal cannula at 0.5 - 2 l/min. All children will be monitored for by pulse oximetry for arterial O2 saturation, respiratory rate, lower chest wall in-drawing, intercostal retraction, head nodding, cyanosis, tracheal tug, heart failure (defined by the presence of tachypnea, tachycardia, gallop rhythm, hepatomegaly, pedal oedema, basal crackles). Arterial or capillary blood gas analyses will be done for children failing to maintain saturation (>90% with allocated treatment), or if there is concern about hypercarbia or acidosis.
16199742|NCT01396733|Drug|alpha-lipoic acids|alpha-lipoic acid 600 mg/day or 1,200 mg/day 600 mg/day - Three tablets (200mg x 3), one time per day for 3 months 1,200 mg/day - Three tablets (200mg x 3), two times per day for 3 months
16199743|NCT01396720|Drug|fluvoxamine|Fluvoxamine 100mg daily, 7 days
16199744|NCT01396720|Drug|citalopharm|Citalopharm 20mg daily, 7 days
16199745|NCT01396707|Drug|Herceptin+XELOX|"Each 3-weekly cycle, with chemotherapy given for 6 cycles, and trastuzumab continued even after completion of the combination chemotherapy until disease progression
~Trastuzumab: 8 mg/kg i.v. loading dose on day 1, followed by 6 mg/kg i.v.infusion every 3 weeks
~Capecitabine: 1000 mg/m2 oral twice daily for 14 days every 3 weeks (from evening on day 1 to morning on day 15)
~Oxaliplatin 130 mg/m2 i.v. on day 1"
16199747|NCT01396681|Drug|gemcitabine and cisplatin|The study consists of three phases; Induction chemotherapy phase:Starting 4~8 weeks after R0 resection of pancreatic cancer. Gemcitabine: 1200mg/㎡ (Day 1, 8), cisplatin 60mg/㎡ (Day 1) every 3 weeks for 2 cycles. Chemoradiotherapy phase: Starting 1-2 weeks after completion of induction chemotherapy (within 5 weeks after D1 of 2nd cycle of induction chemotherapy), no later than 16 weeks after operation. Gemcitabine 300mg/㎡ weekly for 5 weeks throughout RT period. Radiotherapy: 50.4Gy at 1.8Gy/Fx, for 28 Fx (Field reduction at 45Gy) for 5.5 pweeks. Maintenance chemotherapy phase: Within 4 weeks after completion of chemoradiotheray, no later than 6 weeks after completion of chemoradiotherapy Gemcitabine: 1200mg/㎡ (Day 1, 8) every 3 weeks, for 4 cycles
16199748|NCT01396668|Drug|gemcitabine, cisplatin, capecitabine|Gemcitabine: 1000mg/㎡ (day 1, 8), cisplatin 60mg/㎡ (day 1) Capecitabine: 650mg/㎡ twice a day, during radiotherapy Gemcitabine: 1000mg/㎡ (day 1, 8)
16199749|NCT01396655|Drug|docetaxel (75 mg/m2) and doxorubicin (50 mg/m2)|The chemotherapeutic regimen consisted of docetaxel (75 mg/m2) and doxorubicin (50 mg/m2) by intravenous infusion every 3 weeks. After three cycles of neoadjuvant chemotherapy, the patients were re-evaluated for response and underwent curative surgery. Radiologic response was evaluated using breast magnetic resonance imaging (MRI) for the primary breast tumor and chest computed tomography (CT) for axillary, supraclavicular, internal mammary lymph nodes with RECIST criteria. Both breast MRI and chest CT were performed in all the 78 patients. Subsequently, the patients received three more cycles of docetaxel and doxorubicin as an adjuvant chemotherapy, followed by hormonal or radiation therapy, if indicated.
16199750|NCT01396642|Other|Topical Emollient|Neonates in this group will receive topical emollient application with coconut oil twice a day till 28th day of life
16199751|NCT01396629|Procedure|cartridge|IOL cartridge coated with polymer material may ensure smooth delivery of IOL during cataract surgery
16199752|NCT01396616|Device|Experimental - Toric Intraocular lenses|Toric Intraocular Lenses will be implenated with cataract patients having astigmatism
16199753|NCT01396590|Drug|Perampanel|6 x 2 mg perampanel once per day
16199754|NCT01396590|Drug|Perampanel|12 mg perampanel once per day
16199755|NCT01396577|Drug|perampanel|3 x 2 mg perampanel once per day
16199756|NCT01396577|Drug|perampanel|6 mg perampanel once per day
16199757|NCT01396564|Drug|Metformin|850 mg of Metformin daily, increased to 1700 mg after 12 weeks, for the duration of the trial.
16199758|NCT01396564|Drug|Pioglitazone|15 mg of pioglitazone daily, increased to 60 mg after 12 weeks.
16199759|NCT01396551|Device|Implantation of anchored Beacon transponder in the lung|Anchored Beacon transponder has an anchoring feature to secure it in the small airways of the lung.
16199760|NCT01396525|Device|Omnilink Elite™ Peripheral Balloon-Expandable Stent System|Patients with treatment of a maximum of two bilateral de novo or restenotic atherosclerotic lesions in the native common iliac artery and/or native external iliac artery (one lesion per side).
16199761|NCT01396512|Biological|Live attenuated Japanese encephalitis chimeric virus vaccine|0.5 mL, Subcutaneous
16199762|NCT01396512|Biological|Japanese encephalitis live attenuated vaccine (SA14 14 2 vaccine)|0.5 mL, Subcutaneous
16199763|NCT01396499|Drug|BKM120|Starting dose 80 mg tablets by mouth daily for a 28 day cycle.
16199764|NCT01396486|Drug|Omega-3|Children with bipolar spectrum disorders ages 6-12 will receive treatment with omega-3 fatty acids. Study subjects may be randomized to receive 3000mg (6 500mg capsules) of omega-3 fatty acids for the duration of the study. Omega-3 fatty acid capsules are in the form of Nordic Naturals brand, ProOmega Junior, which contains 325mg EPA and 225mg DHA per two capsules.
16199765|NCT01396486|Drug|Inositol|Children with bipolar spectrum disorders ages 6-12 will receive treatment with inositol, omega-3 fatty acids, or both weekly for 12 weeks. Subjects weighing 25kg or more may be randomized to receive 2000mg (4 500mg capsules) of inositol (80mg/kg for a 25kg child). Children weighing less than 25kg will be dosed at 80mg/kg rounded down to the nearest thousand mg dose. Dosage will remain constant throughout the study.
16199766|NCT01396473|Behavioral|Policy and Environmental Change|Afterschool programs participate in an assessment of physical activity and nutrition practices and policies. Study staff work with teams of afterschool programs in a participatory manner to identify areas in which programs would like to take practice, policy and communication efforts to meet physical activity and nutrition goals. Teams share progress and barriers during ongoing collaborative meetings.
16199767|NCT01396460|Other|breakfast (a chicken sandwich with juice)|patients received a breakfast after de initial measurement
16199768|NCT01396447|Drug|Placebo|Placebo was supplied in capsules.
16199769|NCT01396447|Drug|Cariprazine|Cariprazine was supplied in capsules.
16199770|NCT01396434|Biological|Prevenar 13|Prevenar 13 vaccine as prescribed by the physician based on approved product indication
16199771|NCT01396421|Drug|OPC-34712 [Brexpiprazole] High Dose|Higher dose, tablet, once daily, for six weeks
16199772|NCT01396421|Drug|Experimental: OPC-34712 [Brexpiprazole] Middle Dose|Middle dose, tablet, once daily, for six weeks
16199773|NCT01396421|Drug|Experimental: OPC-34712 [Brexpiprazole] Low Dose|Lower dose, tablet, once daily, for six weeks
16199774|NCT01396421|Drug|Placebo|Placebo, once daily, for six weeks
16199775|NCT01396408|Drug|Sunitinib|50 mg PO daily for 28 days, q 6 weeks (1 cycle=6 weeks or 42 days)
16199776|NCT01396408|Drug|Temsirolimus|25 mg IV weekly (Days 1, 8, 15, 22, 29, 36), q 6 weeks (1 cycle=6 weeks or 42 days)
16199777|NCT01396395|Drug|Nicorandil|The subjects will receive Nicorandil 5 mg tablet orally three times daily for a period of 12 weeks along with the standard treatment.
16199778|NCT01396395|Drug|Standard Treatment|The subjects will receive one of the standard anti-anginal therapies which included but not limited to aspirin, ACEI, lipid lowering statins and beta blockers according to the recommendation of guidelines. If the subject's condition permitted, they should take all these medicines. However, the dose, route, frequency and duration were determined by investigators according to subject's specific condition.
16199821|NCT01396174|Behavioral|Standard Online Support Group|Six weekly 1.5 hour online support group meetings facilitated by a Cancer Support Community staff member. This online support group will focus on encouraging self-expression.
16199822|NCT01396161|Drug|PF-05175157 or Placebo|One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once daily for 14 days immediately before breakfast, in healthy volunteers.
16199949|NCT01395173|Procedure|Standard|Subjects will undergo standard colonoscopy without position changes during scope withdrawal.
16199779|NCT01396382|Radiation|68Ga-DOTATATE PET scan|68Ga-DOTATATE will be given in tracer doses and injected intravenously to image tumors by Positron Emission Tomography (PET). Efficacy of the 68Ga-DOTATATE PET scan was assessed and compared to 111In-Pentetreotide scan and to scans with CT and/or MRI. Safety and toxicity were also assessed with pre-injection and post-imaging vital signs, pulse oximetry on room air, 12 lead ECGs, and blood laboratory tests, including tumor markers, liver and renal functions and blood counts, and direct patient questioning. Late delayed tumor markers, liver and renal functions and blood counts were assessed when available.
16199780|NCT01396369|Drug|Birth control|In the initial visit, History and Physical Exam,menstrual history, pregnancy history, documentation of hirsutism using Ferriman-Gallwey scoring,body weight, height, and body mass index.The baseline ultrasound blood tests. After the lab tests, the patients in the control group will be started on OC (standard clinical practice) and those in the treatment group will be started on OC with Brevail (2 pills once a day). The patients will return to the clinic for a follow up visit after 3 months. If no side effects, Brevail and OC will be continued for 3 more months. The control group will also have a follow up after 3 months of OC. Six months after the initiation of the study, the patients in the both groups will have another H&P as well as repeat ultrasound and blood tests.
16199781|NCT01396369|Drug|Birth control plus Brevail|In the initial visit, History and Physical Exam,menstrual history, pregnancy history, documentation of hirsutism using Ferriman-Gallwey scoring,body weight, height, and body mass index.The baseline ultrasound blood tests. After the lab tests, the patients in the control group will be started on OC (standard clinical practice) and those in the treatment group will be started on OC with Brevail (2 pills once a day). The patients will return to the clinic for a follow up visit after 3 months. If no side effects, Brevail and OC will be continued for 3 more months. The control group will also have a follow up after 3 months of OC. Six months after the initiation of the study, the patients in the both groups will have another H&P as well as repeat ultrasound and blood tests.
16199782|NCT01396356|Procedure|GI procedures|If you agree to participate in the study, you will undergo a series of tests about a week before the expected ablation procedure. The same tests will be repeated 24-48 hours after the ablation. These tests include esophageal manometry, gastric emptying scan, sham feeding test and completing a symptoms questionnaire.
16199783|NCT01396330|Behavioral|stress|3 professional safe drive training courses each lasting 30 minutes
16199784|NCT01396317|Drug|Tocilizumab|Tocilizumab is a humanized anti-interleukin-6 receptor antibody that has been FDA approved for the treatment of rheumatoid arthritis (RA). This molecule binds to the IL-6 binding site of human IL-6 receptor, and competitively inhibits IL-6 signaling.
16199785|NCT01396304|Device|Restore Calcium Alginate Dressing|Wound dressing appropriate for venous leg ulcers. Dressing to be changed minimally once per week.
16199786|NCT01396304|Device|AquaCel Ag Wound Dressing|Wound dressing appropriate for venous leg ulcers. Dressing to be changed minimally once per week.
16199787|NCT01396291|Drug|asenapine|asenapine, sublingual tablets, 5 to 10 mg twice per day (BID)
16199788|NCT01396291|Drug|placebo|asenapine-matched placebo, sublingual tablets, BID
16199789|NCT01396278|Drug|Placebo|2 puffs BID placebo matching fluticasone propionate HFA MDI
16199790|NCT01396278|Drug|Placebo|2 puffs BID placebo matching BI54903 Respimat
16199791|NCT01396278|Drug|Fluticasone propionate|2 puffs BID 88 mcg Fluticasone propionate HFA MDI
16199792|NCT01396278|Drug|BI 54903|2 puffs BID BI 54903 via Respimat inhaler
16199793|NCT01396278|Drug|Fluticasone propionate|2 puffs BID 220 mcg Fluticasone propionate HFA MDI
16199794|NCT01396278|Drug|Placebo|2 puffs BID placebo matching BI54903 Respimat
16199795|NCT01396278|Drug|BI 54903|2 puffs BID BI 54903 via Respimat inhaler
16199796|NCT01396278|Drug|BI 54903|2 puffs BID BI 54903 via Respimat inhaler
16199797|NCT01396278|Drug|Placebo|2 puffs BID placebo matching fluticasone propionate HFA MDI
16199798|NCT01396278|Drug|Placebo|2 puffs BID placebo matching fluticasone propionate HFA MDI
16199799|NCT01396265|Drug|Afatinib|single dose
16199800|NCT01396265|Drug|Afatinib|single dose
16199801|NCT01396265|Drug|Rifampicin|multiple doses
16199802|NCT01396252|Drug|BMS-820836|Tablets, Oral, 0.5 mg, Once daily, 14 days
16199803|NCT01396252|Drug|BMS-820836|Tablets, Oral, 1 mg, Once daily, 14 days
16199804|NCT01396252|Drug|BMS-820836|Tablets, Oral, 2 mg, Once daily, 14 days
16199805|NCT01396252|Drug|Placebo matching BMS-820836|Tablets, Oral, 0 mg, Once daily, 14 days
16199806|NCT01396252|Drug|BMS-820836|Tablets, Oral, (initiated at 1 mg and dose escalated to the target dose of 2 mg), Once daily, 14 days
16199807|NCT01396239|Drug|AVI-4658 (Eteplirsen)|Treatment group 1 (n=4): 50.0 mg/kg eteplirsen once weekly x 24 weeks via a 60-minute i.v. infusion Treatment group 2 (n=4): 30.0 mg/kg eteplirsen once weekly x 24 weeks via a 60-minute i.v. infusion Treatment group 3 (n=4): matching placebo once weekly x 24 weeks via a 60-minute i.v. infusion; treatment group 3a will match two placebo subjects to 50.0 mg/kg eteplirsen; treatment group 3b will match two placebo subjects to 30.0 mg/kg eteplirsen
16199808|NCT01396239|Other|Placebo|sterile, isotonic, clear, colorless phosphate buffered saline solution of eteplirsen at a concentration of 100 mg/mL in single-use vials containing a nominal volume of 1.0 mL without preservatives.
16199809|NCT01396226|Drug|AZD2927|A single dose of AZD2927 administered as an iv infusion
16199810|NCT01396226|Drug|Placebo|A single dose of placebo administered as an iv infusion
16199811|NCT01396213|Drug|Larazotide Acetate|gelatin capsule
16199812|NCT01396213|Drug|placebo|gelatin capsule
16199813|NCT01396200|Drug|Hydroxychloroquine|Dose level 1: 800mg by mouth daily Dose level -1: 600 mg by mouth daily
16199814|NCT01396200|Drug|Rapamycin|Dose level 1: Loading dose 12mg, daily dose 4mg Dose level -1: Loading dose 9mg,daily dose 3mg
16199815|NCT01396187|Drug|PF-05231023|5 mg IV twice a week for 4 weeks
16199816|NCT01396187|Drug|PF-05231023|25 mg IV twice a week for 4 weeks
16199817|NCT01396187|Drug|PF-05231023|100 mg IV twice a week for 4 weeks
16199818|NCT01396187|Drug|PF-05231023|200 mg IV twice a week for 4 weeks
16199819|NCT01396187|Other|Placebo|0.9% w/v sodium chloride injection, United States Pharmacopeia (USP), twice a week IV for 4 weeks
16199820|NCT01396174|Behavioral|prosocial online support group|Six weekly 1.5 hour online support group meetings facilitated by a Cancer Support Community staff member. This online support group will maximize opportunities to provide help to others.
16199823|NCT01396161|Drug|PF-05175157 or Placebo|One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once daily for 14 days immediately before breakfast, in healthy volunteers.
16199824|NCT01396161|Drug|PF-05175157 or Placebo|One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once daily for 14 days immediately before breakfast, in healthy volunteers.
16199825|NCT01396161|Drug|PF-05175157 or Placebo|One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule twice daily for 14 days, immediately before breakfast and dinner, in healthy volunteers.
16199826|NCT01396161|Drug|PF-05175157 or Placebo|One oral dose of PF-05175157 or placebo is administered as a powder-in-capsule once (or twice) daily for 14 days, immediately before breakfast (and dinner), in patients with type 2 diabetes.
16199827|NCT01396148|Drug|sunitinib malate dose escalation|sunitinib starting dose will be 15mg/m^2 daily on a 4 weeks on/2 weeks off schedule (Schedule 4/2).
16199828|NCT01396148|Drug|sunitinib malate|sunitinib 50mg daily on Schedule 4/2
16199829|NCT01396135|Drug|CP-601,927|Single dose of 1 mg CP-601,927 given as oral 1 mg tablets
16199830|NCT01396135|Drug|CP-601,927|Single dose of 2 mg CP-601,927 given as oral 1 mg tablets
16199831|NCT01396135|Drug|CP-601,927|Single dose of 3 mg CP-601,927 given as oral 1 mg tablets
16199832|NCT01396135|Drug|Placebo|Single dose of placebo given as a matching number of oral tablets
16199833|NCT01396135|Drug|CP-601,927|Multiple doses of CP-601,927 given as 2 mg BID (4 mg/day) as oral 1 mg tablets for 7 days
16199834|NCT01396135|Drug|Placebo|Multiple doses of placebo given as a matching number of oral tablets
16199835|NCT01396122|Procedure|Procedure: GYNECARE PROSIMA* Pelvic Floor Repair System|Perform surgery with GYNECARE PROSIMA* Pelvic Floor Repair System. Vaginal hysterectomy or mid-urethral sling procedure for incontinence could be performed concurrently.
16199836|NCT01396109|Procedure|Procedure: TVH and GYNECARE PROSIMA* Pelvic Floor Repair System|Subjects of this group were submitted to surgical treatment with GYNECARE PROSIMA* Pelvic Floor Repair System concurrently with transvaginal hysterectomy.
16199837|NCT01396109|Procedure|Procedure: TVH and Modified Pelvic Floor Reconstruction Surgery with mesh|Subjects of this group were submitted to surgical treatment of Modified Pelvic Floor Reconstruction Surgery with mesh concurrently with transvaginal hysterectomy.
16199838|NCT01396083|Drug|Ranibizumab|
16199839|NCT01396083|Drug|Dexamethasone implant and sham injections|
16199840|NCT01396070|Drug|Brentuximab vedotin|"1.8 mg/kg by IV every 3 weeks for a maximum of 16 doses (8 cycles).
~Brentuximab vedotin is an antibody conjugate, consisting of the chimeric IgG1 anti-CD30 antibody cAC10; the microtubule disrupting agent monomethyl auristatin E (MMAE); a protease-cleavable linker that covalently attaches MMAE to cAC10."
16199841|NCT01396057|Drug|Ranibizumab|Injections consisted of 0.5 mg/0.05 ml solution to be injected intravitreally. Ranibizumab was formulated as a sterile solution aseptically filled in a sterile glass vial. It was suitable for single use only and the content of the vial was not allowed to be split
16199842|NCT01396057|Other|Dexamethasone Implant|Comparator Ozurdex® (dexamethasone) was formulated as a rod shaped implant to be inserted into the eye by an applicator. The implant as well as the respective applicator were suitable for single use only.
16199843|NCT01396057|Other|Sham injection|Sham injection: Empty sterile syringes were provided so that masking could be maintained. Either empty syringes in the case of sham injections or pre-filled syringes in the case of ranibizumab injections were visible to the patient in the room of study drug administration
16199844|NCT01396044|Other|Electronic checklist|Electronic checklist for process of care issues implemented in our institution. Training on a regular basis of the electronic checklist arm to use the electronic checklist. Process of care issues on the electronic checklist include several that are under investigation: antibiotics and mechanical ventilation.
16199845|NCT01396044|Other|Verbal prompting|Prompting by study investigators of physicians on the verbal prompting arm. Prompting will include questions related to antibiotic utilization and mechanical ventilation weaning.
16199846|NCT01396031|Behavioral|Physical Therapy|Standard of care
16199847|NCT01396005|Drug|boceprevir|boceprevir 800 mg (4 x 200 mg capsules), orally, every 8 hours, Day 2 through Day 7
16199848|NCT01396005|Drug|methadone|methadone, 20-150 mg tablets, liquid, or disket, orally, once per day, Day 1 through Day 8
16199849|NCT01396005|Drug|buprenorphine/naloxone|buprenorphine/naloxone 8/2-24/6 mg, tablets, sublingual, once per day, Day 1 through Day 8
16199850|NCT01395992|Drug|asenapine|asenapine 5 mg tablet, sublingually (SL) twice daily (BID) for 182 days
16199851|NCT01395992|Drug|asenapine|asenapine 10 mg tablet, SL BID for 182 days
16199852|NCT01395979|Behavioral|Cognitive Processing Therapy for Sexual Risk|Eight weekly sessions, 4 modules.
16199853|NCT01395979|Behavioral|Supportive Psychotherapy|Eight weekly sessions
16199854|NCT01395979|Behavioral|Sexual Risk Reduction Intervention|Two weekly sessions.
16199855|NCT01395966|Drug|DF289|Ear drops
16199856|NCT01395966|Drug|DF277|Ear drops
16199857|NCT01395966|Drug|DF289 plus DF277|Ear drops
16199858|NCT01395953|Drug|Buspirone|Children with Autism Spectrum Disorders will receive buspirone or matched placebo. Buspirone will be titrated to the maximum daily dose during the first four weeks of the trial (dose titration phase). Week 4 onwards subjects will be maintained on maximum achieved dose till the end of the trial (dose maintenance phase). During the titration phase total dose of buspirone will be increased at each visit by 5mg and on the 4th day after each visit by 5mg.
16199859|NCT01395953|Drug|Placebo|Children with Autism Spectrum Disorders will receive buspirone or matched placebo. Buspirone will be titrated to the maximum daily dose during the first four weeks of the trial (dose titration phase). Week 4 onwards subjects will be maintained on maximum achieved dose till the end of the trial (dose maintenance phase). During the titration phase total dose of buspirone will be increased at each visit by 5mg and on the 4th day after each visit by 5mg.
16199860|NCT01395940|Drug|KLH-2109|
16199861|NCT01395940|Drug|KLH-2109|
16199862|NCT01395927|Drug|Rifampin|Type=2, unit=mg, number=300, Form=capsule, route=oral use. Two 300-mg capsules once daily on days Days 4 through 12.
16199863|NCT01395927|Drug|Canagliflozin|Type=1, unit=mg, number=300, form=tablet. Single dose of one 300-mg tablet on Day 1 and Day 10
16199864|NCT01395914|Drug|Anamorelin HCl|
16199865|NCT01395914|Drug|Placebo|
16199867|NCT01395901|Drug|Ondansetron|"Single dose Ondansetron IV:
~0 months to 12 years dose: 0.1 mg/kg for ≤ 40 kg and 4 mg for >40 kg;
~13 years to less than 17 years dose: 4 mg"
16199868|NCT01395901|Drug|Placebo to Ondansetron|
16199869|NCT01395901|Drug|Placebo to Palonosetron|
16199870|NCT01395888|Drug|fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) 100/25 mcg Novel Dry Powder Inhaler (NDPI)|fluticasone furoate (FF, GW685698)/vilanterol (VI, GW642444) 100/25 mcg Inhalation Powder delivered once daily via a Novel Dry Powder Inhaler (NDPI)
16199871|NCT01395888|Drug|Tiotropium|• Tiotropium (18 mcg) administered QD via a HandiHaler
16199872|NCT01395875|Drug|Fluticasone Propionate / Salmeterol Xinafoate Combination (FSC)|COPD patients receiving fluticasone propionate/salmeterol xinafoate combination (FSC) 250/50mcg
16199873|NCT01395875|Drug|Anticholinergics (AC)|COPD patients receiving anticholinergics (ACs) including tiotropium (TIO) and ipratropium or combination ipratropium-albuterol (collectively referred to as ipratropium [IPR]).
16199874|NCT01395862|Drug|Salmeterol and Fluticasone|
16199875|NCT01395849|Drug|Salmeterol and Fluticasone|
16199876|NCT01395823|Dietary Supplement|ergocalciferol supplementation|50,000 IU given either weekly; weekly for 3 months then monthly for 3 months; monthly
16199877|NCT01395823|Other|placebo|placebo pill given weekly, weekly for 3 months then monthly for 3 months; monthly
16199878|NCT01395810|Drug|nonacog beta pegol|One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience.
16199879|NCT01395810|Drug|nonacog beta pegol|One single dose administered intravenously (into the vein). Patients will treat themselves with either a low or a high dose dependent on the severity of the bleeding episode.
16199880|NCT01395810|Drug|nonacog beta pegol|One single dose administered intravenously (into the vein) every second week. Patients will receive instruction on how to treat any bleeding episode they may experience.
16199881|NCT01395797|Drug|PIO|0, 15, and 45 mg per day.
16199882|NCT01395797|Drug|Placebo|Placebo
16199883|NCT01395784|Drug|pioglitazone|A PPARγ agonist, also marketed as Actos. Participants will be maintained on ascending doses of Placebo, pioglitazone 15 mg and 45 mg, prior to completing a lab session at the end of each dosing period.
16199884|NCT01395771|Behavioral|Phone call intervention, no phone call intervention|Biweekly phone call intervention +routine service will be assigned to intervention group of new cases and old cases. Only routine service will be assigned to the control group of abovementioned two kind of cases.
16199885|NCT01395758|Drug|ARQ 197 plus erlotinib|Eligible subjects will be randomly assigned to receive erlotinib plus ARQ 197.
16199886|NCT01395758|Drug|Pemetrexed, docetaxel or gemcitabine|Investigator's choice of a single agent chemotherapy (pemetrexed, docetaxel, or gemcitabine) administered according to the approved label.
16199887|NCT01395745|Drug|blisibimod|blisibimod administered via subcutaneous injection every week for 52 weeks
16199888|NCT01395745|Drug|Placebo|Placebo will be administered weekly via subcutaneous injection for 52 weeks
16199889|NCT01395732|Drug|Bosentan|2 tablets of 62.5 mg a day from baseline to week 4, then 2 tablets of 125 mg per day to week 12.
16199890|NCT01395719|Other|Remote ischemic conditioning|Patients receiving kidney transplantation from a deceased donor. Remote ischemic conditioning (rIC) is done by inflating a tourniquet (250mmHg) on the patients leg before reperfusion of the kidney. The tourniquet stays on the leg on the opposite site of were the kidney is placed. rIC is done 4 x 5 min with 5 min intervals between with free blood flow.
16199891|NCT01395706|Procedure|ICG Fluorescence technique|"This is an uncontrolled, non-randomised, open-label, monocenter clinical trial.
~A total of n=125 subjects will participate in this clinical trial. No clinical trial participant will be allowed to be included in this trial more than once.
~10 mg (5mg/ml)per injection are applicated"
16199892|NCT01395693|Device|Salt Lake mask system|Study participants will Salt Lake mask system for 1 week in place of their current mask system.
16199893|NCT01395667|Other|CCRT|Combined IMRT with three escalated dose levels (45 Gy, 50 Gy, and 55 Gy in 25 fractions) and Bevacizumab-fluorouracil/ leucovorin/oxaliplatin (FOLFOX) regimens
16199894|NCT01395654|Drug|isoniazid, rifampin, pyrazinamide|rechallenge of isoniazid (INH), rifampin (RIF), and pyrazinamide (PZA) aftr recovery from hepatitis
16199895|NCT01395641|Drug|gene therapy|AAV2-hAADC viral vector will be injected into bilateral putamen by stereotactic surgery.
16199896|NCT01395628|Drug|in vitro sensitivity-directed chemotherapy|
16199897|NCT01395628|Other|cell proliferation assay|
16199898|NCT01395628|Other|fluorescence activated cell sorting|
16199899|NCT01395628|Other|laboratory biomarker analysis|
16199900|NCT01395628|Other|microscopy|
16199901|NCT01395602|Drug|Cabergoline|cabergoline 0.5 mg twice weekly
16199902|NCT01395602|Other|placebo|1 pill twice weekly
16199903|NCT01395589|Drug|Vitamin D|Children with moderate-to-severe asthma exacerbations and vitamin D levels < 25 ng/mL underwent masked randomization, and then open dosing to either IM+oral (the latter daily) therapy or daily oral-only therapy, and were followed for 12 months.
16199904|NCT01395576|Device|Genu Neurexa orthosis|Knee orthosis for the prevention of knee hyper extension
16199905|NCT01395563|Behavioral|strength training|strength training, high intensity, twice up to 3 times per week
16199906|NCT01395537|Drug|Carboplatin AUC|Carboplatin AUC 6 IV over 30 minutes on day one of a three week cycle. This will be continued for 6 cycles or until progression of disease or intolerable side effects.
16199907|NCT01395537|Drug|Paclitaxel|Paclitaxel 175 mg/m2 IV over 3 hours day one of a three week cycle. This will be continued for 6 cycles or until progression of disease or intolerable side effects.
16199908|NCT01395537|Drug|lapatinib|Lapatinib should be taken once daily, at the same time daily, on an empty stomach, either 1 hour before, or 1 hour after meals.
16199909|NCT01395524|Drug|NKTR-118|12.5 mg oral tablet once daily
16199910|NCT01395524|Drug|NKTR-118|25 mg oral tablet once daily
16199911|NCT01395524|Drug|Placebo|Oral tablet intake once daily
16199912|NCT01395511|Device|Acupuncture|"Tool : Acupuncture Seirin SJ 0.16 * 40 (mm) / SJ 0.18 * 50 (mm) L-type needles were used for the study.
~Made from stainless steel needle SEIRIN JAPAN"
16199987|NCT01394874|Behavioral|TLC|Computer-based telephone linked communication will be used to counsel subjects to adhere to their exercise program over time.
16199913|NCT01395498|Other|laboratory testing of PCP and CMV genetic material|laboratory testing of PCP and CMV DNA in bronchoalveolar lavage fluid, CMV PCR in blood+ serology in patients with positive BAL.
16199914|NCT01395485|Drug|AMG 827 or Placebo|A single dose of AMG 827 or matching placebo is to be administered subcutaneously (SC).
16199915|NCT01395472|Behavioral|Acute Physical Exercise|Patients and healthy volunteers will be submitted to a protocol of progressive maximal exercise until voluntary exhaustion and one weak later to 30 minutes of physical exercise in ventilatory threshold I, both in the same cycloergometer.
16199916|NCT01395472|Behavioral|Stretching protocol|TBI patients will be submitted to 30 minutes of stretching exercises composed of 15 exercises that prioritize back, legs and hip.
16199917|NCT01395459|Behavioral|IVR only|As noted, patients in this arm receive consistent, but spaced out calls generated by an interactive voice response system reminding them of breast, cervical and colon cancer screenings needed, as applicable.
16199918|NCT01395459|Behavioral|IVR+PCC|Interactive voice response calls followed up by prevention care coordinator calls for those who do not respond to IVR
16199919|NCT01395433|Drug|Escitalopram|2 x 10 mg, single dose
16199920|NCT01395433|Drug|Escitalopram|2 x 10 mg, single dose
16199921|NCT01395433|Drug|Escitalopram|1 x 20 mg, single dose
16199922|NCT01395420|Drug|CAZ104|IV Infusion
16199923|NCT01395420|Drug|CAZ104|IV Infusion
16199924|NCT01395407|Radiation|Radiosurgery dose escalation|"Cohort A: resection cavity volume up to 4.2 cc (corresponds to 0 - 2 cm diameter).
~Cohort B: resection cavity volume > 4.2 cc and ≤ 14.1 cc (2 - 3 cm diameter) Cohort C: resection cavity volume > 14.1 cc and ≤ 35 cc (3 - 4 cm diameter)
~Dose level Cohort A (Gy) Cohort B (Gy) Cohort C (Gy)
~21 18 15
~23 20 17
~25 22 19"
16199925|NCT01395394|Drug|Kuvan|Participants in the BH4 Non-Responder group will be given a 20 mg/kg body weight/day dose of Kuvan to take on a daily basis for two weeks. The last dose will be administered at the participant's study visit 2.
16199926|NCT01395394|Other|Meal Challenge|At each study visit, patients will receive a meal high in polyunsaturated fats that will promote a transitory increase in oxidative stress measures and endothelial dysfunction
16199927|NCT01395381|Drug|Placebo|placebo given once
16199928|NCT01395381|Drug|Albendazole|single dose albendazole given at the time of enrollment
16199929|NCT01395355|Behavioral|Linking Individuals Being Emotionally Real (LIBER8)|Participants will attend a 8-12 week, 1-2 hours long intervention comprised of cognitive behavior and dialectical behavior therapy techniques.
16199930|NCT01395355|Behavioral|Weight Management Control|Participants will attend a 8-12 week, 1-2 hours long intervention comprised of behavioral techniques.
16199931|NCT01395342|Other|Exercise using stationary bicycle|"Before exercise, blood pressure and heart rate are measured in the sitting position.
~Exercise is realized using stationary bicycle (horizontal bench mode) once at week, during 20 minutes under physiotherapist supervision.
~The heart rate was maintained at 20% above resting heart rate and up to 140 bpm.
~After exercise is performed a leg stretching and a low back stretching. The blood pressure and heart rate are measured in the sitting position."
16199932|NCT01395329|Drug|Nebivolol|5 mg tablet to be taken by mouth once per day for 12 weeks
16199933|NCT01395329|Drug|Metoprolol|100 mg tablet to be taken by mouth once per day for 12 weeks
16199934|NCT01395329|Drug|Placebo|gelatin capsule to be taken by mouth once per day for 12 weeks
16199935|NCT01395329|Other|Forearm Blood Flow (FBF) response to BQ-123 (100 mol/min)|The forearm blood flow response to the endothelin (ET) -1 A receptor blocker BQ-123 (100 nmol/min) for 60 minutes at baseline and at 12 weeks.
16199936|NCT01395329|Other|FBF response to BQ-123 (100 nmol/min)+BQ-788(50 nmol/min)|The FBF response to the nonselective endothelin (ET) -1 receptor blockade BQ-123 (100 nmol/min) + BQ-788 (50 nmol/min)for 60 minutes at baseline and at 12 weeks.
16199937|NCT01395329|Other|FBF response to Acetylcholine|The FBF response to the endothelium-dependent vasodilator ACh (4, 8 and 16 ug/100 mL tissue/min) at baseline and at 12 weeks.
16199938|NCT01395329|Other|FBF response to Sodium Nitroprusside|The FBF response to the endothelium independent vasodilator NTP (1,2 and 4 ug/100 mL tissue/min) at baseline and at 12 weeks.
16199939|NCT01395329|Other|FBF response to BQ-123+BQ-788+ACh|The FBF response to the nonselective endothelin (ET) -1 receptor blockade BQ-123 (100 nmol/min) + BQ-788 (50 nmol/min)for 60 minutes at baseline and at 12 weeks.
16199940|NCT01395316|Drug|Alemtuzumab|10 mg/ml alemtuzumab intravenous infusion, sterile clear, colorless solution. dosage: 2 cycles. Month 0 dosed over 5 consecutive days: month 12 dosed over 3 consecutive days.
16199941|NCT01395290|Drug|cholecalciferol|20.000 IU per week, oral
16199942|NCT01395277|Dietary Supplement|High Flavanol first then Low Flavanol|The high flavanol trial will be performed following consumption of a beverage containing 1,050 mg of commercially available Cocoa Flavanols which will be mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption. The low flavanol trial will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols which will be mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption.
16199943|NCT01395277|Dietary Supplement|Low Flavanol first then High Flavanol|The low flavanol trial will be performed following consumption of a beverage containing 0 mg of Cocoa Flavanols which will be mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption. The high flavanol trial will be performed following consumption of a beverage containing 1,050 mg of commercially available Cocoa Flavanols which will be mixed into 250 ml of distilled water. The subjects will consume this beverage and measurements will be performed 2 hours after consumption.
16199944|NCT01395251|Drug|Prednisolone|prednisolone 20 mg once a day per os for 3 subsequent days
16199945|NCT01395238|Behavioral|Fathers Supporting Success in preschoolers|Group-based, 8 weekly session for 2.0 hours/week.
16199946|NCT01395199|Drug|Amlodipine|5mg PO initially; may be reduced to 2.5mg PO if side effects
16199947|NCT01395186|Procedure|varicocelectomy|varicocelectomy for painful varicocele
16199948|NCT01395173|Procedure|Position change|Patients will be randomly assigned to two groups: Control group (those who will receive standard colonoscopy without position changes) and Position change group (those who will undergo position changes during colonoscope withdrawal during colonoscopy). Subjects in position change group will be asked to shift into three different positions during colonoscope withdrawal.
16199950|NCT01395147|Drug|Lu AA21004|Lu AA21004 10 mg, tablets, orally, once daily for 2 weeks; reduced to 5 mg or increased to 20 mg, once daily if necessary according to the responses and symptoms of participants for up to 50 weeks.
16199951|NCT01395134|Device|Neuromonitoring|Electrical stimulation of the nerve: 1 mA, 4 Hz with surface electromyography of the vocalis muscles.
16199952|NCT01395121|Drug|nilotinib|nilotinib 400 mgs orally twice daily until disease progression or withdrawal from treatment
16199953|NCT01395108|Drug|Nemonoxacin|oral once daily
16199954|NCT01395095|Other|rehabilitation+telephonic coaching|intervention starts 2 weeks after ending standard CR and is based on five phonebased coaching sessions at 6 weeks intervals up to 6 months. Each coaching session includes 5 stages: (1) Asking questions to establish patient's knowledge, attitude and beliefs about their risk factors; (2) Explanation and rationale; (3) Assertiveness training; (4) Goal setting; (5) Reassessment.
16199955|NCT01395095|Other|OPTICARE-B|standard CR according to the guidelines consisting of (a) 2 times a week exercise program of 1.5 hours during 12 weeks, (b) upon request of the patient: participation in multifactorial lifestyle and risk factor sessions (medical information, dietary advises and emotional advises, information about risk factors, smoking cessation program and stress management sessions).
16199956|NCT01395095|Other|OPTICARE-C|(a) standard CR consisting of 2 times a week exercise program of 1.5 hours during 12 weeks. (b) (mandatory) participation in multifactorial lifestyle and risk factor sessions: i.e. 4 sessions of 2 hours each (medical information, dietary advises, risk factors and emotional advises). If applicable, patients will participate in smoking cessation, dietary and stress management programs . (c) Individual sessions and a personalized home-based program to promote an active life style upon instruction of a physiotherapist and physical activity counselor during and after completion of rehabilitation. Activity monitors will be used to provide feedback. (d) Additional compulsory supervised multifactorial lifestyle and risk management training sessions of each 2 hours provided at 4, 6 and 12 months.
16199957|NCT01395069|Drug|Nepafenac 0.1%|1 drop QID for 1 month
16199958|NCT01395069|Drug|Ketorolac 0.5%|1 drop QID for 1 month
16199959|NCT01395069|Other|Placebo (sterile saline drops)|1 drop QID for 1 month
16199960|NCT01395043|Procedure|Placing bilateral TAP-catheters preoperatively|Place bilateral TAP-catheters preoperatively and give repeated boluses of local analgetics in order to treat postoperative pain after colon-surgery.
16199961|NCT01395043|Drug|Bupivacain 2.5 mg/ml with epinephrine bolus in TAP-catheters|Intermittent boluses of Bupivacain 2.5 mg/ml with epinephrine, 20 ml in each catheter every 12 hours for the first 2 postoperative days.
16199962|NCT01395030|Diagnostic Test|Computed Tomography|Undergo FCH PET/CT
16199963|NCT01395030|Drug|18F-fluoromethylcholine|Undergo FCH PET/CT
16199964|NCT01395030|Diagnostic Test|Positron Emission Tomography|Undergo FCH PET/CT
16199965|NCT01395017|Drug|dasatinib|GEM 1000 mg/m2 by intravenous [IV] infusion weekly for 3 weeks of a 4-week cycle plus dasatinib 100 mg (or matched placebo) by mouth once daily (QD). Subjects will continue to receive study treatment until disease progression, unacceptable toxicity, withdrawal of consent, or study termination.
16199966|NCT01395017|Drug|Placebo|Matching Placebo
16199967|NCT01395004|Drug|GSK2110183|GSK2110183 was orally administered at 125 mg once daily.
16199968|NCT01394991|Drug|Epoetin alfa 450 IU/kg once a week|450 IU/kg once a week by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks.
16199969|NCT01394991|Drug|Epoetin alfa 150 IU/kg 3 times a week|150 IU/kg 3 times a week by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks.
16199970|NCT01394991|Drug|Epoetin alfa 450 IU/kg once a week (QW)|450 IU/kg once a week (QW) by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks
16199971|NCT01394991|Drug|Epoetin alfa 150 IU/kg 3 times a week (TIW)|150 IU/kg 3 times a week (TIW) by subcutaneous injection preferably in the abdomen for up to 4 weeks after the last dose of chemotherapy for a maximum of 26 weeks.
16199972|NCT01394978|Other|Control|Standard surgical techniques including staples and sutures.
16199973|NCT01394978|Device|ProGEL Pleural Air Leak Sealant with standard surgical closure|ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG). Standard closure means, for example, suturing or stapling of visible air leaks incurred during resection of lung parenchyma.
16199974|NCT01394978|Device|ProGEL Pleural Air Leak Sealant without standard surgical closure|ProGEL is a single-use medical device that is formed as a result of mixing two components: (1) a solution of human serum albumin (HSA) and (2) a synthetic cross-linking component of polyethylene glycol (PEG). Standard closure means, for example, suturing or stapling of visible air leaks incurred during resection of lung parenchyma.
16199975|NCT01394965|Procedure|ECG electrodes|Cardiac mapping of patients before and after ablation to develop future treatment/diagnostic options for cardiac patients.
16199976|NCT01394952|Drug|Dulaglutide|Administered subcutaneously
16199977|NCT01394952|Drug|Placebo|Administered subcutaneously
16199978|NCT01394939|Biological|JX-594|Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)
16199979|NCT01394939|Drug|Irinotecan|180 mg/m2 IV every 2 weeks.
16199980|NCT01394926|Drug|Optison|Optison is a sterile non-pyrogenic suspension of perflutren for IV administration.
16199981|NCT01394913|Drug|Reumatocept (etanercept)|50mg each week for 30 weeks
16199982|NCT01394913|Drug|Enbrel (etanercept)|50mg each week for 30 weeks
16199983|NCT01394900|Behavioral|CNU Intervention|Notions that strengthen the closeness with one's partner, connect with similar couples, and visibly strengthen a community as key to combating dynamics that cause poor communication, isolation, fragmentation of the Black MSM community.
16199984|NCT01394900|Behavioral|WP Intervention|Attention control condition - WP focuses on nutrition, fitness, healthcare, and stress management. Given the prevalence of health problems among the target population, WP emphasizes adherence to medical guidance and medication regimens.
16199985|NCT01394887|Drug|Metformin|850 mg of metformin twice daily over 12 weeks
16199986|NCT01394887|Drug|placebo|850 mg gel capsules with starch (6.8 calories)as placebo
16200028|NCT01394471|Drug|Intranasal Oxytocin Spray|6 insufflations (24IU of oxytocin total) given twice daily for 12 weeks
16199988|NCT01394861|Device|ESD using Master Slave Robotic System|Endoscopic submucosal dissection of early gastric cancer or broad sessile polyp using Master Slave Robotic System
16199989|NCT01394848|Device|Endothelial cell capture stent with 1 month clopidogrel|75mg PO clopidogrel per day for 1 months
16199990|NCT01394848|Device|Everolimus eluting stent with 12 month clopidogrel|75mg PO clopidogrel per day for over 12 months
16199991|NCT01394848|Drug|Atorvastatin 20mg loading|Atorvastatin 20mg loading before index percutaneous coronary intervention
16199992|NCT01394848|Drug|Atorvastatin 80mg loading|Atorvastatin 80mg loading before index percutaneous coronary intervention
16199993|NCT01394835|Drug|Alpha -1 Antitrypsin|Inhalation twice daily of 160mg
16199994|NCT01394835|Drug|Alpha-1 Antitrypsin|Inhalation twice daily .Dosage 160mg
16199995|NCT01394835|Drug|AAT|Inhalation twice daily' 160mg
16199996|NCT01394809|Behavioral|motor cognitive therapies|pre-test; 6 weeks intervention: week 1-3: 5 times per week 60 minutes a day. Week 4-6: 3 times per week 60 minutes a day; post-test; follow-up)
16199997|NCT01394796|Dietary Supplement|Epigallocatechin-3-gallate (EGCG)|EGCG normally works as a dietary supplement. EGCG administration in Down syndrome patients will result in an improvement of their cognitive performance.A a daily oral dose containing 9 mg/kg (range 6.9-12.7) of EGCG is given during three months.
16199998|NCT01394796|Drug|Placebo|No active treatment is given.
16199999|NCT01394783|Device|Miller laryngoscope|Phase 1 and 2: Endotracheal intubation using the Miller laryngoscope with blade 0 or 1 according to weight of infant.
16200000|NCT01394783|Device|Storz videolaryngoscope|Phase 1: Endotracheal intubation using the videolaryngoscope with blade 0 or 1 according to weight of infant. Videolaryngoscope will be used to proceed to endotracheal intubation indirectly with the use of the video monitor for guidance. Phase 2: Endotracheal intubation using the classic laryngoscope with Miller blade 0 or 1 according to weight of infant.
16200001|NCT01394770|Drug|Aliskiren|Aliskiren 150 mg for 1 month with forced uptitration to 300 mg compared in parallel group with amlodipine 5 mg with forced uptitration to 10 mg
16200002|NCT01394757|Drug|Esketamine hydrochloride|Bolus: 15 mg/kg over 1 minute, followed by a maintenance infusion of 0.25 mg/kg/h for 19 minutes.
16200003|NCT01394731|Drug|Acetaminophen|
16200004|NCT01394731|Drug|Meperidine|
16200005|NCT01394718|Drug|Intravenous Acetaminophen|Scheduled doses of 15 mg/kg of IV acetaminophen will be administered to the treatment arm of the study for a total of 8 doses over a 48 hour period post-operatively.
16200006|NCT01394718|Other|Placebo|Saline placebo will be given at the time of skin closure intra-operatively and will continue to receive IV saline for 44 hours post-operatively. Doses will be administered every 6 hours (total of 8 doses).
16200007|NCT01394705|Device|BodyMedia|Accelerometer
16200008|NCT01394692|Procedure|intraoperative MRI-guided tumor resection|tumor resection with the use of an intraoperative MRI
16200009|NCT01394692|Procedure|standard microsurgery|microsurgical tumor resection
16200010|NCT01394679|Drug|(99m Tc) ECDG (Ethylenedicysteine-Deoxyglucose)|One injection of Technetium-99m Ethylenedicysteine-Deoxyglucose to yield a target dose of 25 mCi (range of 20-30 mCi)by IV push and less than 1 mg of EC-DG
16200011|NCT01394679|Drug|18 F FDG followed by PET/CT imaging|Single injection of 18 F FDG range of 10-20 mCi
16200012|NCT01394653|Drug|YM060|oral, with water
16200013|NCT01394640|Biological|Reassortant vaccine virus NYMC X-179A (New York Medical College, New York) derived form the A/california/7/2009 (H1N1) virus|The vaccine was administered intramuscularly as a single dose of 7.5 ug of hemagglutinin antigen.
16200014|NCT01394627|Drug|Eplerenone|100mg x 2
16200015|NCT01394627|Drug|Placebo|
16200016|NCT01394614|Biological|A/H1N1 vaccine|Verify if exposure to Arepanrix vaccine increase risk of developing narcolepsy in 16 weeks post-vaccination.
16200017|NCT01394588|Device|Use of continuous glucose monitor during surgery. ( Medtronic Minimed Guardian REALTime Continuous Glucose Monitor)|Use of continuous glucose monitor during surgery.
16200018|NCT01394575|Radiation|IMRT with an simultaneous integrated boost|IMRT in 25 fractions delivering 45Gy to the whole breast and 60Gy to the tumor bed
16200019|NCT01394562|Drug|Ferinject (ferric carboxymaltose)|Subjects will receive ferric carboxymaltose intravenously on Day 0, Week 6, and Week 12
16200020|NCT01394562|Other|Standard of Care|Subjects randomised to Standard of Care may receive oral iron at Investigator's discretion however patients will not be permitted to receive IV iron
16200021|NCT01394536|Device|Battery-operated electroacustimulation device (Inactive)|In the sham arm, this device will not be turned on. The device to be used is the ReliefBand (Aeromedix, Jackson, Wy), an FDA-approved, reusable, battery-operated electroacustimulation device. The ReilefBand is a portable battery powered (lithium coin cells) device that is worn on the wrist like a watch. Two electrodes contact the skin with the aid of the application of electroconductive gel, and an electrical current of 25 mHz is transmitted through the skin. The device is applied at the Neiguan (P6) point, which is located on the inside of the wrist and is thought, in traditional Chinese medicine, to relieve nausea and vomiting (NV).
16200022|NCT01394536|Device|Battery-operated electroacustimulation device (Active)|The device to be used is the ReliefBand (Aeromedix, Jackson, Wy), an FDA-approved, reusable, battery-operated electroacustimulation device. The ReilefBand is a portable battery powered (lithium coin cells) device that is worn on the wrist like a watch. Two electrodes contact the skin with the aid of the application of electroconductive gel, and an electrical current of 25 mHz is transmitted through the skin. The device is applied at the Neiguan (P6) point, which is located on the inside of the wrist and is thought, in traditional Chinese medicine, to relieve nausea and vomiting (NV).
16200023|NCT01394523|Drug|Bupivacaine|0.25% or 0.5%
16200024|NCT01394510|Drug|N-acetylcysteine|600 mg N-acetylcysteine (NAC) twice daily by mouth for 2 weeks followed by 1200 mg NAC twice daily by mouth for 2 additional weeks.
16200025|NCT01394497|Drug|N-acetylcystein|15 min systemic NAC infusion of the donor (30 mg/kg, maximum dose 3000 mg) diluted into 500 ml 5 % glucose solution, 30 min before initiating the liver harvesting procedure, and a loco-regional infusion (150 mg/kg of estimated liver weight, maximum dose 300 mg) into the portal vein 5 min before cross-clamping.
16200026|NCT01394484|Other|Intervention I|Four servings of dairy foods (milk and yogurt) per day for 42 days.
16200027|NCT01394484|Dietary Supplement|Intervention II|1200 mg of supplemental calcium and 400 IU of vitamin D3 for 42 days
16200029|NCT01394458|Other|30 % ethanol / 4% sodium citrate catheter locking solution|This solution is locked into the lumens of hemodialysis catheters between treatments to prevent infection and thrombosis. Before each dialysis session, the solution should be removed and discarded.
16200030|NCT01394458|Drug|Heparin 1000 u / ml|In the control group, heparin 1000 u / ml will be locking into the hemodialysis catheters between treatments to prevent thrombosis. The heparin solution should be removed and discarded before each dialysis session.
16200031|NCT01394445|Drug|Physostigmine|continuous intravenous infusion per syringe pump (13 vials of 2 mg/5 ml --> 26 mg/65 ml; 1 ml = 0.4 mg Physostigmine) at rate of 1 mg/h (2.5ml/h) for 24 hours
16200032|NCT01394445|Drug|Placebo|"continuous intravenous infusion of 65 ml NaCl 0.9% with syringe pump at rate of 2.5 ml/h for 24 hours
~PCA: Patient-controlled analgesia with hydromorphone 0.2 mg/ml, on demand: bolus of 0.2 mg, maximum 5 boli per hour; 4-hour-maximum 4 mg"
16200033|NCT01394432|Procedure|PCI and Stem Cells or Placebo injections|Conventional percutaneous coronary intervention after acute myocardial infarction. Harvest of bone marrow from iliac crest. Mesenchymal autologous stem cells preparation (7-10 days after PCI). LV mapping with Noga system (7-10 days after PCI). Randomization 1:1. Stem Cells or placebo implantation.
16200034|NCT01394419|Drug|N-acetylcysteine|N-acetylcysteine 150 mg/kg bolus over 15 min after induction of anesthesia, followed by an infusion of 150 mg/kg/day for 24 hrs
16200035|NCT01394419|Drug|Saline|Equal volume of normal saline
16200036|NCT01394406|Drug|Ketamine|ketamine 3 mg/kg mixed to intravenous patient controlled analgesia device (fentanyl 20 mcg/kg. total volume 180 ml, basal infusion 2 ml, bolus 2ml, lock-out 15 min)
16200037|NCT01394406|Drug|Saline|equal volume of normal saline mixed to intravenous patient controlled analgesia device
16200038|NCT01394393|Behavioral|Experiential-Cognitive Therapy for Obesity|Is a relatively short-term, integrated, patient oriented approach that focuses on individual discovery (Riva, Bacchetta, Baruffi, Rinaldi, & Molinari, 1998, 1999; Riva et al., 2000). It shares with the cognitive-behavioral approach proposed by Cooper and colleagues the use of a combination of cognitive and behavioral procedures to help the patient identify and change the maintaining mechanisms (Cooper et al., 2003). However, it considers morbid obesity as a peculiar form of addiction. So, as in the cognitive-behavioral treatment of addictions (Carroll et al., 1994) the two main goals are the functional analysis of the maintaining mechanisms and the required skill training (relapse prevention).
16200039|NCT01394393|Behavioral|Behavioral cognitive Treatment|Therapists will follow a detailed manual that outlined the content of each session. This manual was based on the cognitive-behavioral treatment approach described by Cooper and colleagues (Cooper & Fairburn, 2002; Cooper et al., 2003). It was developed during a year of intensive pilot work and adapted to the in-patient setting. Patients will be taught to self-monitor their food intake and eating patterns and thoughts, as well as the circumstances and environment surrounding eating (e.g. whether eating alone or with others, speed of eating, and place of eating). Patients will also be taught to identify problems in eating, mood, and thinking patterns and to gradually develop alternative patterns.
16200040|NCT01394393|Dietary Supplement|Nutritional groups (NT)|5 weekly nutritional treatment based on the LEARN manual (Brownell, 1985), whose goal will be to provide practical guidelines for the self-monitoring of eating and lessons on nutrition (e.g stressing gradual weight loss with the caloric restriction achieved largely by reductions in fat intake), plus a low-calorie diet (1,200 kcal/day) and physical training (30 min of walking two times a week as a minimum).
16200041|NCT01394380|Other|artificially sweetened sodas|subjects will be allowed unlimited consumption of calorie-free, artificially-sweetened sodas, water, tea or coffee
16200042|NCT01394367|Other|respiratory and exercise therapy|Conventional therapy with diet, massage, relaxation baths, plus easy strolls specific respiratory and physical therapy plus mental walking training
16200043|NCT01394354|Drug|Vorinostat|"Vorinostat 100 mg/d p.o., on day 1-4, 8-11, and 15-18 /28 day treatment cycle in combination with BDD.
~The dose level of Vorinostat will be escalated in each new cohort:
~if no dose limiting toxicity (DLT) has been observed in the previous dose level in 3 patient, the second cohort of 3 new patients will be treated with Vorinostat 200 mg/d p.o. and the third cohort will be given Vorinostat with 300 mg/d p.o."
16200044|NCT01394354|Drug|Bortezomib|1.3mg/m2 (days 1,8,15)/28 day treatment cycle, i.v., for max. 6 treatment cycles
16200045|NCT01394354|Drug|Doxorubicin|18mg/m2 i.v. (days 1 and 8)/ 28 day treatment cycle, max. 6 treatment cycles
16200046|NCT01394354|Drug|Dexamethasone|40mg abs. p.o. (days 1,8,15,22) 1st treatment cycle, 20mg abs. p.o.(days 1,8,15,22) 2-6 treatment cycles
16200047|NCT01394341|Drug|Liraglutide|Daily sc. injection, individual dosage
16200048|NCT01394289|Biological|Lolium allergen extract|"This is an open, unblinded and non randomized biological as proposed by the Nordic Guidelines.
~Four concentrations of Lolium perenne allergen extract, together with a positive and negative control, using 10 mg/ml histamine dihydrochloride solution and a glycerinated phenol saline solution, respectively, will be tested in every patient in duplicate on the volar surface of the forearm. This test will be referred to as the Titrated Skin Prick test."
16200049|NCT01394263|Drug|Histrelin hydrogel implant|50 mg histrelin acetate in hyrogel implant
16200050|NCT01394263|Drug|Zoladex goserelin implant|goserelin implant injection.
16200051|NCT01394250|Device|Buzzy|Cold, Vibrational Device
16200052|NCT01394250|Drug|Topical Lidocaine 4% Cream|Applied to anticipated IV site at least 30 minutes prior to cannulation.
16200053|NCT01394237|Other|Examination|Examination of recurrences of vaginal vault prolapse measured as objective anatomical results using the pelvic organ prolapse quantification (POP-Q) system
16200054|NCT01394224|Drug|Levetiracetam|Strength: 100 mg/mL Form: Concentrate for solution for infusion Frequency: Single dose
16200055|NCT01394224|Drug|Levetiracetam|Levetiracetam tablets Strength: 500 mg Form: Tablet Frequency: Single dose
16200056|NCT01394211|Drug|anastrozole|Given PO
16200057|NCT01394211|Drug|pazopanib hydrochloride|Given PO
16200058|NCT01394211|Procedure|therapeutic conventional surgery|Undergo definitive surgery
16200059|NCT01394185|Drug|Dronabinol 120mg/day|Participants receive 40mg dronabinol 3 times daily
16200060|NCT01394185|Drug|Placebo|Participants receive placebo
16200061|NCT01394185|Drug|Dronabinol 240mg/day|Participants receive 80mg dronabinol 3 times daily
16200153|NCT01393496|Other|red blood cell transfusion|"Implementation of restrictive guidelines for red blood cell transfusions in extremely low birth weight infants"
16200062|NCT01394159|Procedure|22G ProCore biopsy needle|Tissue will be acquired with the 22G Procore biopsy needle and the sample will be compared to the sample obtained with the 22G standard FNA needle.
16200063|NCT01394159|Procedure|22G standard FNA needle|Tissue will be acquired with the 22G standard FNA biopsy needle and the sample will be compared to the sample obtained with the 22G ProCore biopsy needle.
16200064|NCT01394146|Other|Research diet|Participants will be provided specially prepared meals to eat at home for two weeks. During the first week, participants will eat foods that do not have any phosphorus-based food additives in them (this is called the control diet). During the second week, participants will eat foods that all have phosphorus-based food additives in them (called the intervention diet).
16200065|NCT01394133|Drug|Tenofovir, Emtricitabine, Atazanavir, Ritonavir|Women will be receiving Tenofovir 300mg, Emtricitabine 200mg, Atazanavir 300mg, Ritonavir 100mg, one dose on 2 separate visits. These medications will not be prescribed from the physician and not provided by the study.
16200066|NCT01394120|Drug|Targeted Therapy Tailored Treatment|"Targeted therapy tailored treatment, based on molecular determination in pancreas cancer specimen
~Tim Synthase (TS) (neg), ERCC-1 (neg), Topoisomerase I (Topo I) (pos) : FOLFIRINOX
~TS (neg), ERCC-1 (neg), Topo I (neg): FOLFOX
~TS (neg), ERCC-1 (pos), Topo I (pos): FOLFIRI
~TS (neg), ERCC-1 (pos), Topo I (neg): Capecitabine/Gemcitabine
~TS (pos), EGFR Not Amplificate, K-Ras Mutation (pos) : Gemcitabine single agent
~TS (pos), EGFR Ampl or K-Ras mut (neg): Gemcitabine plus Erlotinib"
16200067|NCT01394120|Drug|Standard Chemotherapy|Patients treated based on investigator´s criteria: : FOLFIRINOX, FOLFOX, FOLFIRI, Capecitabine-Gemcitabine, Erlotinib-Gemcitabine or Gemcitabine single agent
16200068|NCT01394094|Behavioral|Gum chewing|Gum chewing(30 minutes in duration each time, 4 times/days at the usual time of meal, until the first flatus) in the addition to conventional postoperative feeding schedule
16200069|NCT01394081|Other|Enhanced Engagement and Enrollment (EEE)|Consists of motivational interviewing, educational outreach, and patient navigation.
16200070|NCT01394081|Other|Administrative Outreach (AO)|Consists of giving information about enrolling for VA medical care or scheduling an appointment
16200071|NCT01394055|Drug|RM-131|100 μg subcutaneously once
16200072|NCT01394055|Drug|Placebo|Matching placebo volume subcutaneously once
16200073|NCT01394042|Device|Proxiscan device|All patients will be imaged with the device
16200074|NCT01394029|Drug|deferasirox|
16200075|NCT01394016|Drug|LY2835219|Administered orally, daily for 28-day cycles for two planned cycles. For Part G only in addition to LY2835219 as above, fulvestrant is administered as specified in the label. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria is met.
16200076|NCT01394016|Drug|Fulvestrant|Fulvestrant is administered intramuscularly into the buttocks as specified in the label in Part G only.
16200077|NCT01394003|Drug|LY2584702|administered orally
16200078|NCT01393990|Drug|LY2228820|Administered orally
16200079|NCT01393990|Drug|Midazolam|
16200080|NCT01393990|Drug|Tamoxifen|
16200081|NCT01393977|Procedure|rehabilitation of limb function|only receive rehabilitation of limb function
16200082|NCT01393977|Procedure|Stem Cells Transplantation|mesenchymal stem cells derived from umbilical cord are transplanted directly into subarachnoid by Lumbar puncture
16200083|NCT01393964|Drug|Lenalidomide|Capsules, Oral, 15 mg, One capsule every 48 hours through Days 1-21 (Repeat every 28 days until subject meets criteria for discontinuation of study drug
16200084|NCT01393964|Drug|Dexamethasone|Tablets, Oral, 28 mg weekly, on day 1 (cycle 1); days 1, 8, 15, 22 (cycles 2-3; days 1 &15 (cycle 4 and beyond) Repeat every 28 days until subject meets criteria for discontinuation of study drug
16200085|NCT01393964|Drug|Dexamethasone|Tablets, Oral, 40 mg, weekly, on days 8, 15 & 22 (cycle 1); days 8 &22 (cycle 4 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
16200086|NCT01393964|Drug|Dexamethasone|Solution, Intravenous, 8 mg, weekly, on day 1 (cycle 1); days 1, 8, 15, 22 (cycles 2-3; days 1 &15 (cycle 4 and beyond) Repeat every 28 days until subject meets criteria for discontinuation of study drug
16200087|NCT01393964|Biological|Elotuzumab (BMS-901608; HuLuc63)|Solution, Intravenous, 10 mg/kg, weekly, on day 1 (cycle 1); days 1, 8, 15, 22 (cycles 2-3; days 1 &15 (cycle 4 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
16200088|NCT01393951|Biological|ASP7374|subcutaneous and intramuscular
16200089|NCT01393938|Other|Three-dimensional ultrasound|Immediately following the standard of care 2D-US, for approximately 15 min.
16200090|NCT01393925|Drug|parecoxib|parecoxib 40mg at 30min before the end of surgery, at 8h and 20h after the surgery, intravenously
16200091|NCT01393912|Drug|Crenolanib|Crenolanib orally administered as whole or crushed tablets once per day with concurrent Radiation Therapy. Crenolanib will continue at the same dose level post Radiation Therapy
16200092|NCT01393899|Drug|Placebo|oral tablets twice daily
16200093|NCT01393899|Drug|CP-690,550|oral tablets twice daily
16200094|NCT01393899|Drug|CP-690,550|oral tablets twice daily
16200095|NCT01393886|Procedure|Laparoscopic Greater Curvature Plication (LGCP)|This procedure creates a small sized stomach by folding the stomach twice into itself vertically. The functional capacity of the stomach is decreased by 80% of its normal(At least two rows of five continuous stitches are placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum).
16200096|NCT01393834|Procedure|Delayed cord clamping|Delay cord clamping for 30 seconds after birth
16200097|NCT01393834|Procedure|Milking of the cord|Milking of the cord 4 times in 10 seconds
16200102|NCT01393808|Drug|Paricalcitol|1-month Paricalcitol 2mcg/day
16200103|NCT01393808|Other|placebo|1-month Placebo Treatment
16200104|NCT01393795|Drug|Qutenza|8% patch
16200105|NCT01393795|Drug|Tegaderm|No active drug
16200195|NCT01393132|Drug|Thymosin Beta 4 eye drops|Patients will be randomized and will receive the same eye drops the Thymosin Beta 4.
16200534|NCT01390571|Procedure|dynamic contrast-enhanced magnetic resonance imaging|
16200106|NCT01393782|Drug|Angiotensin II|All patients will have their vasopressors titrated to a mean arterial pressure (MAP) of 65 mm of Hg (standard MAP goal in the ICU for patients suffering from shock). Patients will then be randomized to control or IV AII. In the interventional arm, AII will start at a dose of 20ng/kg/min; the dose can then be titrated up to 30ng/kg/min, and then to 40ng/kg/min. The intervention will last for 6 hours. Each patient will start with the assigned starting dose indicated above. After the first hour, if the patient is still requiring standing norepinephrine (the standard vasopressor for the treatment of shock in the GW ICU), the dose of the control/interventional drug can be increased 50%. After the second hour, if the patient is still requiring a standing dose of norepinephrine, the control/interventional can be increased again to twice the initial dose. At the end of 6 hours, the study drug will be titrated off.
16200107|NCT01393769|Drug|Melphalan|The usual number of chemotherapy cycles will be 3. First treatment with Melphalan will be initiated as soon as possible, once the patients are selected for the study. Once the first treatment has been completed, day 0, successive treatments will be considered, second and third (days 21 and 42). In those cases in which some patients could be considered for an additional treatments after the third cycle, these will be administrated in intervals at least of 21 days.Dosage range from 3 to 5 mg, depending of patient's weight and estimated tumour volume.
16200108|NCT01393756|Drug|Lenalidomide and R-CHOP|Lenalidomide dose administered orally during 14 days in combination with 6 courses of fixed doses of R-CHOP 21.
16200109|NCT01393743|Drug|Perampanel|
16200110|NCT01393743|Drug|Placebo comparator|
16200111|NCT01393730|Drug|Abiraterone acetate|
16200112|NCT01393730|Drug|Dutasteride|
16200113|NCT01393730|Drug|Prednisone|
16200114|NCT01393717|Drug|brentuximab vedotin|Given IV
16200115|NCT01393704|Drug|Vasopressin|Dilute vasopressin solution will be injected subserosally into myoma at time of minimally invasive myomectomy.
16200116|NCT01393691|Behavioral|CBT with parent involved play|This is a CBT adaptation designed for preschool children, which includes multiple standard cognitive-behavioral techniques, namely psycho-education, problem solving via play, gradual exposure and reinforcement management.
16200117|NCT01393691|Behavioral|Triadic expressive play therapy|Based on expressive play therapy guidelines, children and their parents will express themes concerning bedtime routines and fears via play.
16200118|NCT01393678|Drug|NISSEL|Biphenyl Dimethyl Dicarboxylate 25mg ............. 1 cap
16200119|NCT01393678|Drug|PENNEL|Biphenyl Dimethyl Dicarboxylate 25mg & garlic oil 50mg ............. 1cap
16200120|NCT01393665|Drug|PENNEL capsule|"hard capsule DDB 25mg & GO 50mg in cap .......... 1 capsule
~1 or 2 capsule, T.I.D"
16200121|NCT01393665|Drug|Placebo|Placebo
16200122|NCT01393652|Drug|PF-05105679|Subjects will receive single ascending doses of PF-05105679 or placebo to investigate safety/tolerability and pharmacokinetics of PF-05105679
16200123|NCT01393652|Drug|PF-05105679|Subjects will receive single ascending doses of PF-05105679 or placebo to investigate safety/tolerability and pharmacokinetics of PF-05105679
16200124|NCT01393652|Drug|PF-05105679|Subject will be randomized to a treatment sequence, and assigned to placebo, 2 separate single doses of PF-05105679 in the fasted state and to controlled-release Oxycodone 20 mg (positive control) , with at least one week wash-out between doses.
16200125|NCT01393639|Drug|PF-04171327|1 mg tablet once daily (QD) for 8 weeks
16200126|NCT01393639|Drug|PF-04171327|5 mg tablet once daily (QD) for 8 weeks
16200127|NCT01393639|Drug|PF-04171327|10 mg tablet once daily (QD) for 8 weeks
16200128|NCT01393639|Drug|PF-04171327|15 mg tablet once daily (QD) for 8 weeks
16200129|NCT01393639|Drug|prednisone|5 mg capsule once daily for 8 weeks
16200130|NCT01393639|Other|prednisone|10 mg capsule once daily for 8 weeks
16200131|NCT01393639|Other|placebo|placebo (tablet or capsule) once daily (QD) for 8 weeks
16200132|NCT01393626|Drug|Placebo|oral tablets twice daily
16200133|NCT01393626|Drug|CP-690,550|oral tablets twice daily
16200134|NCT01393626|Drug|CP-690,550|oral tablets twice daily
16200135|NCT01393613|Drug|OPC-34712|Higher dose tablet, once daily, for six weeks,
16200136|NCT01393613|Drug|OPC-34712|Middle dose tablet, once daily, for six weeks
16200137|NCT01393613|Drug|OPC-34712|Lower dose tablet, once daily, for six weeks
16200138|NCT01393613|Drug|Placebo|Placebo, once daily, for six weeks
16200139|NCT01393600|Drug|NBI-98854|12.5 mg powder in bottle once daily for 14 days
16200140|NCT01393600|Drug|NBI-98854|50 mg powder in bottle once daily for 14 days
16200141|NCT01393600|Drug|Placebo|Solution containing no active substance
16200142|NCT01393587|Procedure|Taking blood samples|
16200143|NCT01393574|Drug|Melatonin|3 mg for body weight <40kg, 6 mg for body weight >40kg, once a day 30-60 minutes before sleep
16200144|NCT01393574|Drug|Methylphenidate|Drug formulary and dose will be decided by the treating neurologist from the available options in Israel (as would be given if not participating in the trial)
16200145|NCT01393561|Drug|Group 1|Brompheniramine + phenylephrine
16200146|NCT01393561|Drug|Group 2|Placebo
16200147|NCT01393548|Drug|brompheniramine + phenylephrine|"Oral solution: brompheniramine (2mg/mL) and phenylephrine (2,5 mg/mL), t.i.d., according weight of patient.
~OR Syrup: brompheniramine (2mg/5mL) and phenylephrine(5 mg/5mL), t.i.d., according weight of patient."
16200148|NCT01393548|Drug|Brompheniramine + pseudoephedrine|Elixir: Brompheniramine (0,2mg/mL) and pseudoephedrine (3,0 mg/mL), t.i.d., according weight of patient
16200149|NCT01393522|Drug|Milnacipran|titration schedule starting with 12.5mg per day increasing to 50mg twice a day, starting with day 1 to day 90 and then will taper down.
16200150|NCT01393522|Drug|Placebo|Tablet will be titrated 1 tablet once a day increased per protocol to 2 tablets twice a day, with a starting dose of 12.5mg per day to 50 mg twice a day
16200151|NCT01393509|Drug|PU-H71|PU-H71 will be administered as an intravenous infusion over 1 hour two times a week on a 2 week on and 1 week off (Q21 day) schedule with a starting dose of 10 mg/m2. A Cycle on study will be defined as 21 days. The same schedule of administration will be used for all patients in this Phase I trial, and a MCRM (modified continual reassessment method)design will be employed. The MPN expansion may explore different dosing schedules.
16200152|NCT01393496|Other|red blood cell transfusion|"Implementation of liberal guidelines for red blood cell transfusions in extremely low birth weight infants"
16200154|NCT01393483|Other|serum and tissue mesothelin|"Tissue mesothelin staining at the time of the initial endoscopy, and of any subsequent biopsy specimen during the endoscopic screening period.
~Serum mesothelin level at the time of initial endoscopy, and at each subsequent endoscopy for two years or until disease recurs."
16200155|NCT01393483|Other|serum and tissue mesothelin|Tissue mesothelin staining on the surgically resected esophageal specimen. Serum mesothelin level at the time of surgical resection, and at each follow-up clinic visit for two years or until disease recurs.
16200156|NCT01393483|Other|serum and tissue mesothelin|Tissue mesothelin staining on the initial endoscopic specimen (typically obtained when an EUS is done) and on the surgically resected esophageal specimen Serum mesothelin level prior to initiation of induction chemotherapy, at the time of the post-induction PET, at the time of surgical resection, and at each follow-up clinic visit for two years or until disease recurs.
16200157|NCT01393470|Procedure|Screening for cervical cancer|Organized screening for cervical cancer start for all cohorts at the age of 25 years with 5 year interval.
16200158|NCT01393457|Drug|levodopa/carbidopa|800/200 mg/d
16200159|NCT01393457|Drug|Ropinirole 2 mg/d|2 mg/d
16200160|NCT01393457|Drug|Placebo|sugar pill
16200161|NCT01393457|Drug|Ropinirole 4 mg/d|4 mg/d
16200162|NCT01393444|Device|Implantation of ECoG sensors on the brain surface|One ECoG sensor will be implanted over the motor cortex of study participants
16200163|NCT01393418|Other|Cardiac Surgery|
16200164|NCT01393405|Drug|Methotrexate|"Induction period (week 1-16) (Open label):
~25 mg MTX sq once weekly + Steroid taper + 1 mg folic acid daily
~Maintenance period (week 17-48) (Randomization):
~25 mg MTX sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine or Placebo sq once weekly + 1 mg folic acid daily + 2.4 g mesalamine"
16200165|NCT01393392|Behavioral|Intensive, tailored intervention|Eight, 45 minute counseling sessions, tailored to the individual and based on the Information-Motivation-Behavioral Skills model of behavior change. Incorporates motivational interviewing, education, cognitive-behavioral skills training. 12 week course of nicotine replacement patches provided. Nicotine lozenges also provided.
16200166|NCT01393392|Behavioral|NJ Quitline Referral|Participants will receive a facilitated referral to the NJ Quitline (i.e. fax to quit).
16200167|NCT01393366|Other|Telephone Intervention|Only for arm AMA, patient will have one phone every week to evaluate physical conditions.
16200168|NCT01393366|Other|Usual Practice|None, only usual practice.
16200169|NCT01393353|Other|Cognitive Training|
16200170|NCT01393353|Other|computer game|
16200171|NCT01393340|Drug|Omalizumab|"Omalizumab (Xolair(R)) is a recombinant DNA-derived humanized IgG1 monoclonal antibody that selectively binds to human IgE. Molecular weight is approximately 149 kilodaltons. Xolair(R) is a sterile, white, preservative-free, lyophilized powder contained in a single-use vial, reconstituted with Sterile Water For Injection (SWFI), and administered as subcutaneous (SC) injection.
~Xolair(R) will be administered subcutaneously in a dose of 75 to 375mg every 2 to 4 weeks. Doses (mg) and dosing frequency are determined by total serum IgE level (IU/ml) measured at the start of treatment and body weight (kg). During this 20-week during trial patients will receive 4 or 8 doses of omalizumab."
16200172|NCT01393340|Drug|Placebo|Placebo
16200173|NCT01393327|Behavioral|respiratory and exercise therapy|Conventional therapy with diet, massage, relaxation baths, plus easy strolls specific respiratory and physical therapy plus mental walking training
16200174|NCT01393314|Device|Honeywell HomMed Telemonitor|telemonitoring post hospitalization
16200175|NCT01393301|Behavioral|Integrated cognitive-behavioral therapy for smoking cessation and anxiety|Standard smoking cessation treatment and nicotine replacement therapy (NRT) plus a cognitive-behavioral therapy for anxiety, depression, or other symptoms of distress.
16200176|NCT01393301|Behavioral|Control|Enhanced standard smoking cessation treatment and NRT.
16200177|NCT01393288|Drug|Ondansetron|8 mg ondansetron ODT or placebo, 1 hour pre-operatively, before discharge, evening of day of surgery, morning of postoperative day (POD) 1, lunch POD 1, evening POD 1, and morning of POD 2
16200178|NCT01393288|Drug|Lorazepam|1 mg Lorazepam or placebo 1 hour preoperatively, before discharge, evening of day of surgery, morning of postoperative day (POD) 1, lunch of POD 1, evening of POD 1, and morning of POD 2.
16200179|NCT01393288|Drug|Aprepitant|40 mg Aprepitant or placebo 1 hour preoperatively and before discharge (placebo for postoperative days 1-2)
16200180|NCT01393275|Other|rehabilitation exercise intervention|"exercise intervention: 15 minutes warm up, 30 minutes strength endurance training, 60 minutes rehabilitation exercise training - once a week
~15 minutes warm up, 30 minutes strength endurance training - once a week"
16200181|NCT01393275|Other|placebo control group|"exercise intervention: 15 minutes warm up, 30 minutes strength endurance training, 5 minutes walking 55 minutes conversation in the group- once a week
~15 minutes warm up, 30 minutes strength endurance training - once a week"
16200182|NCT01393223|Drug|LP-08 80mg|Intravesical instillation of 80mg LP08
16200183|NCT01393223|Drug|Normal saline|Intravesical instillation of normal saline
16200184|NCT01393223|Drug|LP-08 20mg|Intravesical instillation of 20mg LP08
16200185|NCT01393210|Dietary Supplement|low calorie diet plus beta-glucan|beta-glucan 1.3D-1.6D, together with a low calorie diet, 500 mg once daily for 12 weeks
16200186|NCT01393210|Other|low-calorie diet|low-calorie diet only for 12 weeks.
16200187|NCT01393197|Other|Therapeutic Chemoembolization|Transcatheter Arterial Chemoembolization
16200188|NCT01393184|Drug|Nimotuzumab and Radiotherapy|Nimotuzumab (Nimo)： Nimotuzumab weekly Nimo (200 mg) × 8, started 1 w before RT
16200189|NCT01393171|Device|Polypropylene mesh (Polyform by Boston Scientific)|Site-specific cystocele repair with polypropylene mesh augmentation
16200190|NCT01393171|Procedure|Porcine Dermis (Pelvicol by CRBard)|Site-specific cystocele repair with porcine dermis augmentation
16200191|NCT01393171|Procedure|Anterior Colporrhaphy|Anterior vaginal prolapse repair with suture.
16200192|NCT01393158|Drug|Apremilast|20mg of Apremilast taken orally BID for 3 months or 30 mg of Apremilast taken orally BID for 6 months.
16200193|NCT01393145|Drug|Combination Fluticasone /Formoterol 12/250 μg|Capsules containing Fumarate formoterol 12 µg + fluticasone propionate 250 µg dry powder for inhalation with aerocaps®
16200194|NCT01393145|Drug|Seretide Diskus (salmeterol/fluticasone) 50/250 μg|Capsules containing salmeterol xinafoate 72.5 µg (equivalent to 50 µg of salmeterol) presented as powder for aspiration, packed in a plastic device in disk format, containing 60 doses
16200196|NCT01393132|Drug|Vehicle Control|Patients will be randomized and will receive the same eye drops without the Thymosin Beta 4.
16200197|NCT01393119|Drug|GTx-758|
16200198|NCT01393119|Drug|GTx-758|
16200199|NCT01393119|Drug|GTx-758|
16200200|NCT01393119|Drug|GTx-758|
16200201|NCT01393106|Drug|Idelalisib|Idelalisib tablets administered orally
16200202|NCT01393093|Procedure|Therapeutic Chemoembolization|Transcatheter Arterial Chemoembolization
16200203|NCT01393080|Drug|Nimotuzumab and TP regimen|"TP Regims：Paclitaxel Liposome,135mg/m2,d1;Carbopatin（AUC=5） d2, 3 weeks/cycle, for 4 cycles.
~Nimotuzumab: 200mg/w, weekly, for 6 weeks; Consolidation treatment， 200mg every 2 weeks, until the end of 4 cycles of chemotherapy or the disease progression."
16200204|NCT01393080|Drug|TP regimen|TP Regimen：Paclitaxel Liposome,135mg/m2,d1;Carbopatin（AUC=5） d2, 3 weeks/cycle,for 4 cycles.
16200205|NCT01393067|Device|Non-expandable plastic stent (plastic endoprosthesis)|plastic stent (plastic endoprosthesis)
16200206|NCT01393067|Device|Covered self-expandable metal stent (cSEMS)|Removable, covered self-expandable metal stent (cSEMS)
16200207|NCT01393054|Drug|Nigella sativa|Drug name: Nigella sativa seed extract in capsule Dosage 300 mg Frequency: twice daily Duration: 4 weeks
16200208|NCT01393041|Device|Angio-Seal VIP|Vascular Closure Device
16200209|NCT01393028|Other|Cardiac CT|Cardiac CT: calcium scan and CT coronary angiography
16200210|NCT01393028|Other|Standard care|Standard care according to international guidelines
16200211|NCT01393015|Device|Automated settings on the oxygen delivery device|FreeO2 automatically adjusts the oxygen flow delivered to patients based on the SpO2 signal. Patients keep using the same device for duration of hospitalization.
16200212|NCT01393015|Device|Manual settings with FreeO2 system in collection mode|Oxygen flow delivery is adjust by nurse and respiratory therapists. Standard medical treatment. Patients keep using the same device for duration of hospitalization.
16200213|NCT01392989|Drug|CIK cells|Standard of care
16200214|NCT01392989|Drug|Cyclosporine|5 mg/kg, po
16200215|NCT01392989|Drug|Mycophenolate Mofetil|15 mg/kg, oral
16200216|NCT01392989|Drug|Thymoglobulin|7.5 mg/kg, IV
16200217|NCT01392989|Radiation|Total Lymphoid Irradiation (TLI)|
16200218|NCT01392976|Drug|CO-1.01 Formulation A (Aqueous suspension containing 15 mg/mL of drug solubilized in purified phospholipids)|1250 mg/m2 intravenous infusion on Day 1 for Treatment Sequence 1 and Day 8 for Treatment Sequence 2.
16200219|NCT01392976|Drug|CO-1.01 Formulation B (Aqueous suspension containing 30 mg/mL of drug solubilized in purified phospholipids)|1250 mg/m2 intravenous infusion on Day 1 for Treatment Sequence 2 and Day 8 for Treatment Sequence 1.
16200220|NCT01392963|Drug|botulinum toxin type A neurotoxin complex|29-40 U injection
16200221|NCT01392963|Drug|Placebo|29-40 U 0.9% NaCl injection
16200222|NCT01392950|Device|Air Optix Aqua|Lenses will be worn on a daily wear basis (ie. removed at night and stored in solution) and worn in the normal way. Lenses will be replaced each month. Lenses should be worn for a minimum of six hours a day, four days a week. The lenses are also to be worn for a minimum of two hours before attending all follow-up visits.
16200223|NCT01392950|Device|Clariti|Lenses will be worn on a daily wear basis (ie. removed at night and stored in solution) and worn in the normal way. Lenses will be replaced each month. Lenses should be worn for a minimum of six hours a day, four days a week. The lenses are also to be worn for a minimum of two hours before attending all follow-up visits.
16200224|NCT01392937|Device|All-in-One Light multipurpose|The study was conducted over two months of wear. Subjects were examined initially, and at three follow-up visits after two weeks, one month and two months.
16200225|NCT01392937|Device|Aquify care|The study was conducted over two months of wear. Subjects were examined initially, and at three follow-up visits after two weeks, one month and two months.
16200226|NCT01392924|Drug|SAR245408|Pharmaceutical form: tablet Route of administration: oral
16200227|NCT01392911|Drug|Rifampicin|High dose rifampicin
16200228|NCT01392898|Drug|liraglutide|liraglutide 1.8 mg q.d.
16200229|NCT01392898|Drug|Insulin|insulin dosed according titration scheme
16200230|NCT01392872|Other|Neuropsychological assessment|This study will evaluate the impact of these treatments on cognitive disabilities, tiredness state, emotion and quality of life in general, on a lengthened period.
16200231|NCT01392859|Drug|Levocetirizine 0.5 Mg/mL Oral Solution|Subjects in two arms, will be enrolled in a classical, randomized, double blind, crossover, placebo controlled trial of Levocetirizine(LCT) with determination of the PD response to LCT as determined by suppression of histamine microvasculature response via HILD.
16200232|NCT01392833|Drug|methylprednisolone|intravenous methylprednisolone 1 g for three consecutive days at the beginning of months 1, 3 and 5
16200233|NCT01392833|Drug|azathioprine|azathioprine 1.5 mg/kg/day for six months followed by azathioprine 50 mg/day for a further six months.
16200234|NCT01392833|Drug|prednisone|prednisone 0.5 mg/kg every other day followed by prednisone 0.2 mg/kg every other day for a further six months.
16200235|NCT01392820|Drug|TC-5214|Tablet, Oral, twice daily
16200236|NCT01392820|Drug|Placebo|Tablet, Oral, twice daily
16200237|NCT01392807|Drug|NKTR-118|25 mg Oral tablets, single dose
16200238|NCT01392794|Drug|YM060|oral, without water
16200239|NCT01392768|Drug|Levetiracetam|Oral solution (Each mL contains 100mg of levetiracetam) or immediate-release tablets (Tablets containing 500mg or 1000mg of levetiracetam)
16200240|NCT01392768|Drug|Placebo|Placebo, properly standardized to suit the characteristics of each dosage form (oral solution and tablets) of levetiracetam
16200241|NCT01392755|Drug|danoprevir|oral doses of danoprevir
16200242|NCT01392755|Drug|omeprazole|oral doses of omeprazole
16200243|NCT01392755|Drug|ranitidine|oral dose of ranitidine
16200244|NCT01392755|Drug|ritonavir|oral doses of ritonavir
16200245|NCT01392716|Drug|rituximab [MabThera/Rituxan]|375 mg/m2 intravenously once a week for 4 weeks
16200246|NCT01392703|Drug|Dasatinib as tablets|2 50-mg tablets plus 240 mL noncarbonated, nonrefrigerated water. Oral, single dose, 1 day
16200247|NCT01392703|Drug|Dasatinib as liquid|100 mg administered as 10 mL of liquid drug (10 mg/mL) plus 230 mL noncarbonated, nonrefrigerated water. Oral, single dose, 1 day
16200387|NCT01391507|Drug|COR-1|Monthly intravenous injection for 6 months
16200248|NCT01392703|Drug|Dasatinib as dispersed tablets|2 50-mg dispersed tablets in 30 mL of 100% orange juice followed by 15 mL of orange juice plus 195 mL noncarbonated, nonrefrigerated water. Liquid (oral solution), single dose, 1 day.
16200249|NCT01392690|Behavioral|Dominique's Handy Tricks|Children assisted to 10 workshops where they learned exercises to control their stress and anxiety.
16200250|NCT01392677|Drug|dapagliflozin|10 mg tablet, oral, once daily, 24- week treatment and 28- week extension period
16200251|NCT01392677|Drug|placebo|matching placebo tablet, oral, once daily, 24- week treatment and 28- week extension period
16200252|NCT01392638|Other|sugar pill|Sugar pills: 37.5, 50.0, and 100.0 mg each 30 minutes.
16200253|NCT01392638|Drug|sildenafil|Sildenafil pills: 37.5, 50.0, and 100.0 mg each 30 minutes.
16200254|NCT01392625|Biological|Autologous hMSCs|"Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:
~Group 1 (18 patients) Eighteen (18) patients will be treated with Auto-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs."
16200255|NCT01392625|Biological|Allogeneic hMSCs|"Cells will be administered via the Biosense Webster MyoStar NOGA Injection Catheter System will be tested in 18 patients via transendocardial injection:
~Group 2 (18 patients) Eighteen (18) patients will be treated with Allo-hMSCs: 20 million cells/ml delivered in a dose of 0.5 ml per injection x 10 injections for a total of 1 x 108 (100 million) Auto-hMSCs."
16200256|NCT01392612|Drug|erythropoietin|Subjects received one single intravenous injection of epoetin alpha (Erypo®, rhEPO, Ortho Biotech/Division of Janssen-Cilag Ag, Bridgewater, New Jersey, US) at a dose of 300 Units per kg bodyweight. Blood was sampled at baseline and 4, 24, 48 and 72 hours after administration of rhEPO during a biosimilarity trial.
16200257|NCT01392599|Procedure|SUBCUTANEOUS VENOUS SYMPATHECTOMY (RSVS)|After incision of the skin a subcutaneous area of approximately 16 cm² (2.5 square inches) will be en block removed between dermis and muscle fascia. All prior detected and marked veins in the operating field will be ligated or coagulated precisely.The tissue defect generated by this operation will be closed by a full thickness or a meshed skin graft which arises during the preparation.
16200258|NCT01392586|Procedure|upfront breast surgery|surgery of primary tumor, lumpectomy or mastectomy
16200259|NCT01392586|Other|systemic therapy|chemotherapy, immunotherapy or endocrine therapy (possibly followed by local surgery of the breast)
16200260|NCT01392573|Drug|insulin degludec/liraglutide|IDeg/Lira treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). IDegLira is injected subcutaneously (under the skin) once daily.
16200261|NCT01392573|Drug|insulin degludec|IDeg treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). IDeg is injected subcutaneously (under the skin) once daily.
16200262|NCT01392560|Drug|BI 10773|Oral once daily
16200263|NCT01392547|Drug|vatreptacog alfa (activated)|1-3 doses per bleeding episode
16200264|NCT01392547|Drug|eptacog alfa (activated)|1-3 doses per bleeding episode
16200265|NCT01392534|Drug|Telmisartan/hydrochlorothiazide (Pritor Plus, BAY98-7103)|Patients treated with telmisartan/hydrochlorothiazide tablets under the real-life setting. Dosing regimen customised to the needs of each participating patient according to the investigators assessment
16200266|NCT01392521|Drug|Copanlisib + Refametinib (BAY86-9766)|Copanlisib will be administered as an IV infusion weekly for 3 weeks in combination with Refametinib (BAY86-9766) at varying dose levels. Refametinib (BAY86-9766) is administered orally twice a day starting at Day 4 of Cycle 1.
16200267|NCT01392521|Drug|Copanlisib + Refametinib (BAY86-9766)|Copanlisib will be administered as an IV infusion weekly in combination with Refametinib (BAY86-9766) at varying dose levels. Refametinib (BAY86-9766) is administered orally twice a day starting at Day 6 of Cycle 1 on a 4 day on, 3 day off schedule.
16200268|NCT01392495|Drug|Imatinib|200 mg or 400 mg qd
16200269|NCT01392469|Drug|Imatinib|Film coated tablets, oral administration
16200270|NCT01392469|Drug|Sildenafil|Oral Administration
16200271|NCT01392469|Drug|Bosentan|Oral Administration
16200272|NCT01392456|Procedure|Insertion of two screw type dental implants|Each patient (of the 69 recruited) will receive 2 screw-type Straumann (Institute Straumann AG, Basel, Switzerland) standard implants Ø4.1 mm, with SLA surface in the canine region of the mandible with an interconnecting line approaching parallelism with the terminal mandibular hinge axis, in a 1-stage non-submerged procedure according to a strict protocol (Weingart D and ten Bruggenkate 2000).
16200273|NCT01392443|Drug|Ruxolitinib|INC424 Tablet for oral use, provided in 5 mg bottles. The dosage strength was 5 mg/tablet INC424 phosphate (free base equivalent).
16200274|NCT01392430|Other|Discontinuation of prophylactic drugs i.e. co-trimoxazole, dapsone, fluconazole, itraconazole, azithromycin|Discontinuation of prophylaxis for opportunistic infections
16200275|NCT01392391|Procedure|Task Oriented Exercise Training|"Treadmill training with safety harnesses begin at 6 to 15 minutes total duration at 40-50% maximal heart rate reserve 3 times per week, increasing to 60-70% maximal heart rate reserve for 30 minutes for 6 months.
~Group dynamic balance exercise immediately follow the treadmill training 3 times a week. Participants also receive Best Stroke Care according to Get with the Guidelines"
16200276|NCT01392391|Procedure|"Stroke Care Get with the Guidelines"|"Post-stroke care is applied according to the recommendations of the American Stroke Association Get with the Guidelines adapted for Jamaica"
16200277|NCT01392378|Biological|13-valent pneumococcal conjugate vaccine|13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
16200278|NCT01392378|Biological|INFANRIX hexa|INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
16200279|NCT01392378|Drug|Paracetamol|Paracetamol suspension for oral administration will be given at a weight adjusted dose of 15mg/kg/dose. The first dose will be given 6-8 hours after each vaccination, the second dose to be given 6-8 hours after the first.
16200280|NCT01392378|Biological|13-valent pneumococcal conjugate vaccine|13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
16200281|NCT01392378|Biological|INFANRIX hexa|INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
16200388|NCT01391507|Drug|Standard therapy for heart failure|All patients will continue to receive standard therapy for heart failure (ie, in accordance with guidelines) throughout the study.
16200282|NCT01392378|Drug|Ibuprofen|Ibuprofen suspension for oral administration will be given at a weight adjusted dose of 10mg/kg/dose. The first dose will be given 6-8 hours after each vaccination, the second dose to be given 6-8 hours after the first.
16200283|NCT01392378|Biological|13-valent pneumococcal conjugate vaccine|13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
16200284|NCT01392378|Biological|INFANRIX hexa|INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
16200285|NCT01392378|Drug|Paracetamol|Paracetamol suspension for oral administration will be given at a weight adjusted dose of 15mg/kg/dose. The first dose will be given at the time of each vaccination, the second dose to be given 6-8 hours after the first, and the third dose to be given 6-8 hours after the second.
16200286|NCT01392378|Biological|13-valent pneumococcal conjugate vaccine|13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
16200287|NCT01392378|Biological|INFANRIX hexa|INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
16200288|NCT01392378|Drug|Ibuprofen|Ibuprofen suspension for oral administration will be given at a weight adjusted dose of 10mg/kg/dose. The first dose will be given at the time of each vaccination, the second dose to be given 6-8 hours after the first, and the third dose to be given 6-8 hours after the second.
16200289|NCT01392378|Biological|13-valent pneumococcal conjugate vaccine|13vPnC will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
16200290|NCT01392378|Biological|INFANRIX hexa|INFANRIX hexa will be administered by intramuscular injection at 2, 3, 4 and 12 months of age.
16200291|NCT01392352|Drug|Pazopanib|2 x 400mg pazopanib tablets taken once daily for 12 weeks
16200292|NCT01392339|Procedure|Continuous Positive Airway Pressure (CPAP)|Continuous Positive Airway Pressure (CPAP) is a method of respiratory ventilation used primarily in the treatment of obstructive sleep apnea
16200293|NCT01392326|Drug|Secukinumab (75 mg)|Secukinumab (75 mg)
16200294|NCT01392326|Drug|Secukinumab (150 mg)|Secukinumab (150 mg)
16200295|NCT01392326|Drug|Placebo Comparator|Placebo Comparator
16200296|NCT01392313|Dietary Supplement|Carnitine|Carnitine Ingestion
16200297|NCT01392313|Dietary Supplement|Placebo|Carnitine placebo
16200298|NCT01392300|Drug|IncobotulinumtoxinA (400 Units)|Main period: One injection session of solution, prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl), 400 units, total volume 8.0 mL; Mode of administration: intramuscular injection
16200299|NCT01392300|Drug|Placebo Comparator|Main period: one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl, corresponding total placebo volume 8.0 mL; Mode of administration: intramuscular injection
16200300|NCT01392287|Drug|Memantine|"Dosing Form: Tablet
~Dosage: 5mg, 10 mg
~Description:
~Memantine hydrochloride (Namenda®), a low to moderate affinity uncompetitive (open-channel) NMDA antagonist, is manufactured and supplied by Forest Laboratories, Incorporated. Only the subjects in the depression group will receive the study drug memantine HCl. Per psychiatrist's instructions, subjects may remain on the maximum dosage of memantine HCl allowed by the study protocol for a given week, or reduce the dosage if concerns regarding tolerability arise. The dosage of memantine HCl cannot be increased more rapidly than the dosing schedule listed below.
~Memantine HCl Dosing Schedule:
~5 mg qAM week 1 5 mg qAM and 5 mg qHS for week 2 10 mg qAM and 5 mg qHS for week 3 10 mg BID for week 4, 5, 6, 7, and 8"
16200301|NCT01392235|Drug|Famitinib|25 mg qd p.o. and it should be continued until disease progression or intolerable toxicity or patients withdrawal of consent
16200302|NCT01392222|Behavioral|Focus groups|"The focus groups will cover the following issues
~Perceptions of thyroid cancer and disease status
~Sources of information used in papillary microcarcinoma treatment decision-making
~Treatment decision-making processes and influential factors
~Perceived barriers to active surveillance to treat papillary microcarcinoma (for the immediate surgery sub-sample)
~Perceived facilitators to active surveillance to treat papillary microcarcinoma (for the non-immediate surgery sub-sample)
~Views about how to improve acceptability of active surveillance as a disease management option"
16200303|NCT01392222|Behavioral|Focus groups|"The focus groups will cover the following issues:
~Perceptions of thyroid cancer and disease status
~Sources of information used in papillary microcarcinoma treatment decision-making
~Treatment decision-making processes and influential factors
~Perceived barriers to active surveillance to treat papillary microcarcinoma (for the immediate surgery sub-sample)
~Perceived facilitators to active surveillance to treat papillary microcarcinoma (for the non-immediate surgery sub-sample)
~Views about how to improve acceptability of active surveillance as a disease management option"
16200304|NCT01392209|Other|Bevacizumab & Stereotactic Radiotherapy|Treatment: (until treatment failure): bevacizumab 10 mg/kg IV once every two weeks on days 1 (+/- 3 days) and 15 (+/- 3 days) of every cycle (Cycle defined as 28 days). On day 28 (or up to 2 days before) of cycles 1 and 2 (and for every other cycle thereafter) patients will undergo a physical and radiological re-evaluation (MRI). Patients will begin stereotactic radiotherapy beginning anywhere from day 7 to day 10 of cycle 2 with escalating fraction sizes (interpatient - there is no intrapatient escalation). Assessment of response will be performed following cycles 1 and 2 then following every two cycles.
16200305|NCT01392196|Procedure|Renal Denervation|Renal Denervation using the Symplicity Catheter in Heart Failure Population
16200306|NCT01392183|Drug|Pazopanib|800 mg by mouth daily in 4 week study cycle.
16200307|NCT01392183|Drug|Temsirolimus|25 mg by vein infused over 30-60 minutes every week in 4 week study cycle.
16200308|NCT01392183|Behavioral|Quality of Life Assessment|Completion of full assessment battery at baseline, prior to treatment then every 8 weeks at clinical evaluation.
16200309|NCT01392183|Drug|Benadryl|25 to 50 mg by vein approximately 30 minutes before the start of each dose of temsirolimus.
16200310|NCT01392170|Drug|PEG-IFNá-2a|45 mcg given subcutaneously as a single weekly dose for 24 months.
16200311|NCT01392157|Device|copper-releasing intrauterine device|100 women received a 380 mm2 of copper releasing intrauterine device
16200312|NCT01392157|Device|ENG-releasing implant|60 mcg/day releasing etonogestrel implant
16200313|NCT01392157|Device|LNG-releasing intrauterine system|a LNG-IUS releasing 20 mcd/day of LNG
16200314|NCT01392157|Device|LNG-IUS|100 women will receive an LNG-IUS
16200389|NCT01391494|Biological|160Eu/0.5ml in adults|inactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 12 adults aged 18-49 years old on day 0, 14.
16200535|NCT01390571|Procedure|therapeutic conventional surgery|
16200315|NCT01392144|Procedure|Nitric oxide breath test|Breathe out into a device (nitric oxide breath analyzer) for 10 seconds; repeated 3 times. Done prior to start of radiation therapy, 1 week before completion of radiation therapy, at completion of radiation therapy, then at each follow-up visit for 6 months.
16200316|NCT01392144|Behavioral|Questionnaires|On day of each breathing test, completion of a breathing and symptom questionnaire, approximately 10 minutes.
16200317|NCT01392131|Dietary Supplement|Oncoxin|20 patients with hepatocellular carcinoma will receive syrup Oncoxin 25 ml bd and capsule Oncoxin 1 cap bd for 24 weeks
16200318|NCT01392131|Other|Supportive treatment|patients will receive only supportive treatment. No chemotherapy, radiotherapy, tumor ablation or surgery will be performed
16200319|NCT01392105|Drug|Mesenchymal stem cell|Route : intracoronary injection Frequency : single dose of autologous bone-marrow derived mesenchymal stem cells Dosage : 1x1000000 cells/kg Duration : mean injection duration approximately 4 weeks after primary percutaneous coronary intervention
16200320|NCT01392105|Drug|Control group|No additional treatment of mesenchymal stem cells
16200321|NCT01392079|Drug|Alemtuzumab|Alemtuzumab 30 mg s.c. 3 × weekly for 28 days (Days 1, 3, 5; 8, 10, 12; etc.)
16200322|NCT01392066|Behavioral|questionnaire|"Both the patient and the partner/spouse fill out a questionnaire that assesses their psychosocial adjustment. Time for completion is ca. 30 minutes.
~The questionnaire is administered at baseline and 5- and 12-months follow up."
16200323|NCT01392053|Other|Lumbosacral Massage|Massage Group (GM) will receive lumbosacral massage for 30 minutes, during uterine contractions between 4-5 cm of cervical dilation.
16200324|NCT01392027|Procedure|Blood Draw|Blood draw for research specimens only
16200325|NCT01392014|Drug|dihydroartemisinin-piperaquine|This study used fixed-dose tablets of 40 mg dihydroartemisinin and 320 mg piperaquine for each tablet (D-ARTEPP®, Guilin Pharmaceutical Co., Ltd, China. The regimen is based on weight for 3 days (D0, D1 and D2) with maximal dose of 1 x 3 tablets for patients weighing ≥ 41 kg; 1 x 2 tablets for patients weighing 31 - 40 kg, 1 x 1.5 tablets for patients weighing 18 - 30 kg, and 1 X 1 tablet for patients with body weight of 11 - 17 kg.
16200326|NCT01392014|Drug|dihydroartemisinin-piperaquine + primaquine|For DHP, treatment was as for Arm dihydroartemisinin piperaquine. A single dose PQ of 0.75 mg/kg BW was provided on Day-3 using 15 mg base PQ tablets (local product by PT Pharos Indonesia, batch no 15306002, produced on 30/05/2008 and expiring on May 2012). The maximal dose was 3 tablets for subjects weighing ≥ 60 kg. The dose range for subjects weighing 10 - 13 kg was 0.5 tablet; 14 - 18 kg was 0.75 tablet; 19 - 23 kg was 1 tablet, 24 -30 kg was 1.5 tablet; 31 - 40 kg was 2 tablets; 41- 49 kg was 2.25 tablet; 50 - 59 kg was 2.5 tablet and ≥ 60 kg was 3 tablets.
16200327|NCT01391988|Procedure|Electric scalpel|Radical mastectomy with electric scalpel. Electric scalpels were calibrated at 40 watts of cutting and coagulation power.
16200328|NCT01391988|Procedure|Harmonic scalpel|Radical mastectomy with harmonic scalpel. Harmonic GEN04 generator calibrated at power leve 3 and 5, using the HP054 handpiece and HF 105 curved blade
16200329|NCT01391975|Procedure|Active ultrasound surveillance of fistula and proactive treatment of stenosis|Regular duplex ultrasound assessment of fistula from time of creation until 6 months post procedure with referral of all haemodynamically significant stenoses to further imaging and treatment
16200330|NCT01391962|Drug|Cediranib|Cediranib, a small molecule inhibitor of VEGF receptor tyrosine kinases, is showing preliminary evidence of activity in patients with ASPS.
16200331|NCT01391962|Drug|Sunitinib|Sunitinib, a small molecule inhibitor of VEGF receptor tyrosine kinases, is showing preliminary evidence of activity in patients with ASPS.
16200332|NCT01391949|Behavioral|Detailed feedback|Once a week subjects will receive feedback about the total time spent cycling and walking in the previous week. Subjects in this intervention group will also receive feedback about average cycling speed, distance pedaled, average walking speed, and distance walked in the previous week.
16200333|NCT01391949|Behavioral|Basic feedback|Once a week subjects will receive feedback about total time spent cycling and walking in the previous week.
16200334|NCT01391936|Procedure|Tension Band Wiring|AO technique of TBW for fixation of fracture.
16200335|NCT01391936|Procedure|Plate fixation|Patients in this arm will receive plate and screw fixation of their olecranon fracture.
16200336|NCT01391923|Device|The Zeltiq System|Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
16200337|NCT01391897|Behavioral|psychotherapy|"multimodal complex psychotherapy"
16200338|NCT01391871|Device|OCT|Optical coherence tomography
16200339|NCT01391871|Device|Transthoracic echocardiography CFR measurement|CFR will be assessed using transthoracic echocardiography with adenosine infusion.
16200340|NCT01391858|Drug|lyrica|150mg of pregabalin/placebo
16200341|NCT01391845|Drug|ulipristal acetate|30mg of ulipristal acetate orally the day of hCG injection in a unique dose
16200342|NCT01391845|Drug|placebo|placebo orally in a unique dose the day of hCG injection
16200343|NCT01391845|Drug|ulipristal acetate|ulipristal acetate 30mg orally in a unique dose the day of hCG administration
16200344|NCT01391845|Drug|placebo|placebo orally in a unique dose the day of hCG injection
16200345|NCT01391832|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|For the sham rTMS with CPT group, the rTMS coil will be placed over the right prefrontal scalp region with the MagStim Rapid Stimulator set to the sham mode so that all conditions are similar to the active delivery mode except that transcranial magnetic stimulation is not administered to the scalp and does not down modulate the right frontal lobe.
16200346|NCT01391832|Behavioral|Cognitive Processing Therapy|Cognitive Processing Therapy (CPT) is a 12 session evidenced based, trauma-focused treatment for PTSD. CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the combat related trauma.
16200390|NCT01391494|Biological|320Eu/0.5ml in adults|inactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 12 adults aged 18-49 years old on day 0, 14.
16200391|NCT01391494|Biological|640Eu/0.5ml in adults|inactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 12 adults aged 18-49 years old on day 0, 14.
16200392|NCT01391494|Biological|1280Eu/0.5ml (without adjuvant) in 12 adults|inactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml (without adjuvant) in 12 adults aged 18-49 years old on day 0, 14.
16200347|NCT01391832|Device|Repetitive Transcranial Magnet Stimulation (rTMS)|For the active rTMS with CPT group, the rTMS coil will be placed over the right prefrontal scalp region with the MagStim Rapid Stimulator set to the active mode. After motor threshold determination, the stimulator coil is positioned over the dorsolateral prefrontal cortex - DLPFC (Brodmann Area 9/46). The right frontal rTMS will safely, reversibly, and temporarily down modulate the right frontal lobe. The conducting coil is placed over the scalp while electrical current pulses pass through the coil. This alternating current turned on and off rapidly produces magnetic pulses (1.5-2.0 Tesla strength) that last for 100 - 300 microseconds. The time-varying magnetic pulses induce an electrical field that will result in current flow in neural tissue, thereby activating or deactivating cortex subjacent to the coil.
16200348|NCT01391819|Other|Data collection|Socio-demographic information, medical history, yellow fever vaccination history and dengue suspicion data collection.
16200349|NCT01391819|Procedure|Blood sample collection|A blood sample will be collected at each of the three scheduled study visits and any time during the study that dengue is suspected. Samples collected at scheduled visits will be tested for anti-dengue antibodies. Samples collected at visits for dengue suspicion will be tested for dengue diagnosis.
16200350|NCT01391793|Drug|Placebo|Twice daily for 3 days
16200351|NCT01391793|Drug|Dexamethasone|0.15 mg/kg/dose twice daily for 3 days
16200352|NCT01391767|Device|NuOss XC|NuOss XC is a bone grafting material that will be placed in extraction socket site.
16200353|NCT01391754|Behavioral|SafeCare|Behavioral home based family preservation. Weekly visits X six months.
16200354|NCT01391754|Other|In vivo coached quality control|Live observation of practice with expert coaching, feedback and fidelity monitoring
16200355|NCT01391754|Behavioral|Services As Usual|Home based services not using the SafeCare model
16200356|NCT01391754|Other|Uncoached|No in vivo coached quality control or fidelity monitoring
16200357|NCT01391741|Other|Visual Cues|Walking with visual cues for 30 minutes, 4 times a week for 4 weeks
16200358|NCT01391741|Other|Walking without visual cues|Walking without visual cues, but verbal encouragement twice a week to take longer steps, for 30 minutes, 4
16200359|NCT01391728|Behavioral|Active Lifestyle all your Life|"Intervention After the first data collection the participants are randomised in an intervention and control group. The control group receives the normal treatment that may be given after a radius fracture and may vary from one care unit to another (but there is no preventive programme within the normal activity as far as we know). In groups of 6-8 participants the intervention group starts the programme Active lifestyle all your life with group meetings around every other week (10-12 times) and with 2 individual meetings directed at discussing fall risks in the participant's own home environment. After a summer break, Christmas and New Year three follow-up meetings take place, one of which is an individual meeting. The intervention is then terminated, but the participants are encouraged to continue the activity themselves."
16200360|NCT01391715|Drug|rabeprazole|rabeprazole 20mg bid per day for 2 weeks
16200361|NCT01391715|Drug|standard dose rabeprazole|rabeprazole 20mg qd per day for 2 weeks
16200362|NCT01391689|Dietary Supplement|diindolylmethane|Given PO
16200363|NCT01391689|Dietary Supplement|placebo|Given PO
16200364|NCT01391676|Procedure|trabeculectomy|postoperative imaging of trabeculectomy blebs with the spectral domain optical coherence tomography
16200365|NCT01391663|Drug|Alogliptin|Alogliptin 12.5 mg, tablets, orally, once daily for up to 7 days.
16200366|NCT01391663|Drug|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for up to 7 days.
16200367|NCT01391663|Drug|Alogliptin|Alogliptin 25 mg, tablets, orally, two tablets taken once daily for up to 7 days.
16200368|NCT01391650|Procedure|'biomechanic of the knee'|20 patients had their ACL replaced by SB reconstruction from hamstrings, 20 patients double - bundle technique with AM bundle being reconstructed first, and 20 patients with the PL bundle first.
16200369|NCT01391637|Biological|HuCNS-SC transplant in the lead-in phase|Long-term safety follow-up study
16200370|NCT01391624|Drug|Flaxseed oil|3 g (3 capsules/day) of flax oil for a period of 8 weeks
16200371|NCT01391624|Drug|Paraffin + # 2 dye|3 capsules of mineral oil (ineffective) for 8 weeks.
16200372|NCT01391611|Drug|Pazopanib|800 mg; PO
16200373|NCT01391598|Drug|Lidocaine|After completion of the inclusion criteria all patients receive a dose of amitriptyline 12.5 mg in the first week, and 25 mg in the eight subsequent weeks, orally, once daily at night. At lidocaine group 20 pacients will receive lidocaine at a dose of 4 mg / kg, not exceeding a dose of 240 mg diluted in 125ml of solution 0.9% saline.The solutions will be infused in 1 hour once a week in the four weeks following the start of the study..:Patients may use as additional analgesics up to 4g/day acetaminophen, and if necessary, they can use tramadol, recording the dose
16200374|NCT01391598|Drug|lidocaine|After completion of the inclusion criteria all patients receive a dose of amitriptyline 12.5 mg in the first week, and 25 mg in the eight subsequent weeks, orally, once daily at night. At saline group 20 pacients will receive 125ml of solution 0.9% saline.The solutions will be infused in 1 hour once a week in the four weeks following the start of the study. Patients may use as additional analgesics up to 4g/day acetaminophen, and if necessary, they can use tramadol, recording the dose
16200375|NCT01391585|Other|Text Message prompts|In this single armed intervention, patients will receive text message prompts
16200376|NCT01391572|Radiation|enlarge irradiation volume|In Arm A, postsurgical radiation target volume includes tumor bed and elective nodes area
16200377|NCT01391572|Radiation|Small volume radiation|In Arm B, postsurgical radiation target volume includes tumor bed only
16200378|NCT01391572|Drug|cisplatin|
16200379|NCT01391572|Drug|fluorouracil|
16200380|NCT01391559|Drug|arformoterol|15 mcg administered via nebulizer
16200381|NCT01391559|Drug|salmeterol|50 mcg delivered vis Diskus
16200382|NCT01391546|Biological|ZOSTAVAX|1 dose 0.65 mL
16200383|NCT01391533|Drug|SAR125844|"Pharmaceutical form:solution
~Route of administration: intravenous"
16200384|NCT01391520|Drug|deferiprone|3 tablets (treatment arm assigned in double-blind, randomized manner) will be given every 12 hours for a total of 8 days, beginning 1-3 hours prior to angiography
16200385|NCT01391520|Drug|Placebo|3 tablets (treatment arm assigned in double-blind, randomized manner) will be given every 12 hours for a total of 8 days, beginning 1-3 hours prior to angiography
16200386|NCT01391507|Drug|0.9 % sodium chloride|Monthly intravenous injection for 6 months
16200393|NCT01391494|Biological|0Eu/0.5ml in adults|0Eu/0.5ml placebo in 24 adults aged 18-49 years old on day 0, 14.
16200394|NCT01391494|Biological|160Eu/0.5ml in children|inactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 12 children aged 3-11 years old on day 0, 14.
16200395|NCT01391494|Biological|320Eu/0.5ml in children|inactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 12 children aged 3-11 years old on day 0, 14.
16200396|NCT01391494|Biological|640Eu/0.5ml in children|inactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 12 children aged 3-11 years old on day 0, 14.
16200397|NCT01391494|Biological|1280Eu/0.5ml (without adjuvant) in children|inactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml (without adjuvant) in 12 children aged 3-11 years old on day 0, 14.
16200398|NCT01391494|Biological|0Eu/0.5ml in children|0Eu/0.5ml placebo in 24 children aged 3-11 years old on day 0, 14.
16200399|NCT01391494|Biological|160Eu/0.5ml in infants|inactivated EV71 vaccine (KMB-17) of 160Eu/0.5ml in 24 infants aged 6-35 months old on day 0, 28.
16200400|NCT01391494|Biological|320Eu/0.5ml in infants|inactivated EV71 vaccine (KMB-17) of 320Eu/0.5ml in 24 infants aged 6-35 months old on day 0, 28.
16200401|NCT01391494|Biological|640Eu/0.5ml in infants|inactivated EV71 vaccine (KMB-17) of 640Eu/0.5ml in 24 infants aged 6-35 months old on day 0, 28.
16200402|NCT01391494|Biological|1280Eu/0.5ml (without adjuvant) in infants|inactivated EV71 vaccine (KMB-17) of 1280Eu/0.5ml (without adjuvant) in 24 infants aged 6-35 months old on day 0, 28.
16200403|NCT01391494|Biological|0Eu/0.5ml in infants|0Eu/0.5ml placebo in 48 infants aged 6-35 months old on day 0, 28.
16200404|NCT01391481|Drug|Perfluorocarbon|Vaporized PFC Inhalation 100ml/8h for 5 days
16200405|NCT01391481|Drug|Sterile Water for Injection|Inhalation of Sterile Water for Injection, 100ml/8h for 5 days
16200406|NCT01391468|Dietary Supplement|Probiotics|intervention group receives probiotics containing 10E9 CFU B. bifidum, B. catenulatum, B. longgim, and L. plantarm in 6 months observations
16200407|NCT01391468|Dietary Supplement|Cornstarch|placebo will be given in 6 months
16200408|NCT01391455|Procedure|Isolation of the spermatic cord from mesh|The spermatic cord is isolated from the mesh employed to repair an inguinal hernia following standard open repair.
16200409|NCT01391442|Biological|blood and urine samples|58 ml of blood 120 ml of urine
16200410|NCT01391442|Genetic|blood sample|11 ml of blood
16200411|NCT01391442|Other|cardiovascular assessment|echography, echodoppler, measure of blood pressure...
16200412|NCT01391442|Other|Stanislas ancillary study : MRI examination with GRICS technique|
16200413|NCT01391429|Behavioral|Video Decision Support Tool|Six minute digital video illustrating specific treatments for three different levels of medical care: life-prolonging care, basic care and comfort oriented care.
16200414|NCT01391403|Drug|Artemisinin|400 mg/day
16200415|NCT01391403|Other|Placebo|400mg/day
16200416|NCT01391390|Drug|Melatonin|10mg/day, 12-week treatment
16200417|NCT01391390|Drug|Placebo|10mg/day, 12-week treatment for TD
16200418|NCT01391377|Drug|Niacin/Laropiprant combination|Niacin 1g / Laropiprant 20mg for 4 weeks followed by Niacin 2g / Laropiprant 20mg for 4 weeks
16200419|NCT01391377|Drug|Sugar pill|Placebo
16200420|NCT01391364|Device|SofLens in investigational solution|SofLens in investigational solution, worn on a daily disposable basis for 7 days.
16200421|NCT01391364|Device|SofLens in currently marketed solution|SofLens packaged in currently marketed solution, worn on a daily disposable basis for 7 days.
16200422|NCT01391351|Other|blood samples|"blood samples in patients receiving Taxol and carboplatin chemotherapy :
~On Day 1 of the first course of chemotherapy
~On Day 1 of the second course of chemotherapy
~Before the surgery, if programmed via J1 or the fourth cycle of chemotherapy
~At the end of chemotherapy"
16200423|NCT01391351|Other|blood samples|"blood samples in patients receiving Taxol and carboplatin chemotherapy with avastin:
~On Day 1 of the first course of chemotherapy
~On Day 1 of the second course of chemotherapy
~Before the surgery, if programmed via J1 or the fourth cycle of chemotherapy
~At the end of chemotherapy"
16200424|NCT01391338|Drug|ASP3652|Oral
16200425|NCT01391338|Drug|Placebo|Oral
16200426|NCT01391325|Drug|Allopurinol|Commercially available allopurinol 100 mg and 300 mg oral tablets will be prescribed by the Investigator according to the approved product label.
16200427|NCT01391312|Biological|botulinum toxin Type A|botulinum toxin Type A 20U (total dose) injected into the glabellar region on Day 0.
16200428|NCT01391312|Drug|normal saline (placebo)|Normal saline (placebo) injected into the glabellar region on Day 0.
16200429|NCT01391299|Biological|botulinum toxin Type A|Botulinum toxin Type A (total dose 30 Units or 40 Units) injected into bilateral forehead and frown line areas on Day 1.
16200430|NCT01391299|Drug|Normal Saline|Normal Saline (placebo) injected into bilateral forehead and frown line areas on Day 1.
16200431|NCT01391286|Drug|bimatoprost solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
16200432|NCT01391286|Drug|bimatoprost vehicle solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
16200433|NCT01391273|Drug|bimatoprost solution 0.03%|One drop of bimatoprost solution 0.03% applied along each upper eyelid margin once daily in the evening for 4 months.
16200434|NCT01391273|Drug|bimatoprost vehicle solution|One drop of bimatoprost vehicle solution applied along each upper eyelid margin once daily in the evening for 4 months.
16200435|NCT01391260|Other|Gefitinib|Radiation Therapy: 3D-CRT/IMRT 95%PTV 60-66Gy, 1.8-2.0Gy/f,5f/w; Gefitinib: 250 mg, Qd, p.o;
16200436|NCT01391234|Radiation|STAT RT planning and delivery workflow|"Patients will receive simulation, planning, quality assurance, and their first treatment in a single day using the STAT RT workflow.
~Patients will receive a total of 1-5 fractions of high dose palliative radiation therapy via TomoTherapy consisting of 5-10 Gray per fraction.
~Data will be collected to evaluate the effectiveness of our novel image co-registration techniques, CT-detector-based exit dose calculations, and infrared patient position monitoring. These novel techniques for image co-registration, radiation dose calculations, and patient position monitoring will not alter or replace standard of care techniques."
16200437|NCT01391221|Drug|Duloxetine|Subjects with major depression will be entered into the trial and treated with duloxetine 30 mg for one week, followed by 60 mg for 8 weeks. The option of increasing the dose as clinically indicated to 120mg is possible for the last 4 weeks of the study intervention
16200438|NCT01391208|Drug|GI heptapeptide|GI heptapeptide, Linear, 7 amino acid peptide sequence ASYNYDA with a 5-FITC tag and NH2 terminus. Chemical Formula: Ala1-Ser2-Tyr3-Asn4-Tyr5-Asp6-Ala7-Gly8- Gly9-Gly10-Ser11-Lys12 (5-FITC) -NH213.Investigational Agent Manufacturer: CPC Scientific, 1245 Reamwood Ave, Sunnyvale, CA 94089 Investigational Agent information: Lot Number: 10031701, M.W. 1577.6, 97.2% pure. Stored at -20C Yellow, lyophilized powder in single use amber vials. 5-FITC is light-sensitive, therefore stored protected from light. Manufactured under cGMP with Certificate of Analysis (COA) provided.
16200439|NCT01391195|Device|Phototherapy by low level laser therapy|Phototherapy by low level laser therapy during 9 weeks
16200440|NCT01391182|Other|EACA|EACA 5 grams IV (mixed in NS) given in two doses: prior to incision (total hip arthroplasty) and repeated 4 hours later.
16200441|NCT01391182|Other|Placebo arm|Placebo (NS) IV given in two doses: prior to incision (total hip arthroplasty) and repeated 4 hours later.
16200442|NCT01391169|Other|seromuscular flap enforcement|seromuscular flap enforcement
16200443|NCT01391156|Drug|3%Minoxidil lotion|3% Minoxidil lotion apply two times a day
16200444|NCT01391156|Drug|3% Minoxidil with 0.1% Finasteride lotion|3% Minoxidil with 0.1% Finasteride lotion apply two times a day.
16200445|NCT01391143|Biological|MGA271|"Up to 9 dose escalation cohorts will be enrolled to determine the maximum tolerated dose of MGA271. Patients with evidence of clinical benefit will be allowed to continue therapy at the same dose once per week for 3 weeks out of every 4-week cycle until documented progression.
~Patients treated in the Expansion Segment at the maximum administered dose will receive weekly, uninterrupted infusions of MGA271 in 8 week cycles for up to 12 cycles."
16200446|NCT01391130|Drug|LY2510924|Administered subcutaneously
16200447|NCT01391130|Drug|Sunitinib|Administered orally
16200448|NCT01391117|Drug|placebo.|panel 1: 2 participants receive placebo at a q24h regimen.
16200449|NCT01391117|Drug|placebo.|panel 3: 2 participants receive placebo. Actual dose and dose regimen (q12h or q24h) to be selected based on the results of the panels 1 and 2.
16200450|NCT01391117|Drug|TMC649128.|panel 2, arm 1: 8 participants receive a q12h regimen of TMC649128 at a selected dose based on results of panel 1.
16200451|NCT01391117|Drug|placebo.|panel 2, arm 2: 2 participants receive placebo at a q24h regimen.
16200452|NCT01391117|Drug|placebo|panel 4, arm 1: 10 participants receive PegIFN a-2a/RBV in combination with placebo, administered q12h or q24h, for 14 days. Actual dose and dose regimen (12h or 24h) is to be selected based on panels 1, 2 and 3.
16200453|NCT01391117|Drug|TMC649128|panel 4, arm 2: 10 participants receive PegIFN a-2a/RBV in combination with TMC649128, administered q12h or q24h, for 14 days. Actual dose and dose regimen (12h or 24h) is to be selected based on panels 1, 2 and 3.
16200454|NCT01391117|Drug|TMC649128.|panel 2, arm 2: 8 participants receive a q24h regimen TMC649128 at a dose based on results of panel 1.
16200455|NCT01391117|Drug|TMC649128|panel 3: 8 participants receive TMC649128. Actual dose and dose regimen (q12h or q24h) to be selected based on the results of the panels 1 and 2.
16200456|NCT01391117|Drug|TMC649128.|panel 1: 8 participants receive a q24h regimen at 1000 mg of TMC649128.
16200457|NCT01391117|Drug|placebo.|panel 2, arm 1: 2 participants receive placebo at a q12h regimen.
16200458|NCT01391104|Drug|Sildenafil|Sildenafil citrate is a phosphodiesterase type-5 inhibitor. Patients will be assigned to sildenafil (20 mg tid) or placebo per os for 28 days in a randomized, double-blind manner. After a four-week wash-out period, patients will then be crossed over to the alternate therapy for the next 28 days.
16200459|NCT01391104|Drug|Sugar Pill|Patients will be assigned to sildenafil (20 mg tid) or placebo per os for 28 days in a randomized, double-blind manner. After a four-week wash-out period, patients will then be crossed over to the alternate therapy for the next 28 days.
16200460|NCT01391091|Procedure|Radiofrequency catheter ablation|PVAI
16200461|NCT01391091|Procedure|Radiofrequency catheter ablation|PVAI
16200462|NCT01391078|Device|Sensimed Triggerfish Sensor|IOP will be monitored for 24 hours
16200463|NCT01391078|Device|Goldmann Applanation Tonometry, Perkins Tonometry|IOP will be measured every two hours within 24 hours
16200464|NCT01391065|Radiation|MR PET Guided Brachytherapy|
16200465|NCT01391052|Drug|Norethindrone acetate pretreatment|5 mg tablets, three times a day for 21 days for 2 menstrual cycles.
16200466|NCT01391052|Other|No pretreatment|LVN IUS is placed withour Norethindrone acetate pretreatment.
16200467|NCT01391039|Drug|Perflutren lipid microsphere|Intravenous injection of 10 microL/kg once prior to ultrasound examination
16200468|NCT01391026|Behavioral|Enhanced patient-centered care|The experimental arm will be referred to a multi-disciplinary clinic
16200469|NCT01391013|Drug|Darunavir(DRV)|Oral administration of tablet DRV 800 mg (2 tablets of 400 mg) once daily at the same time, within 30 minutes after food for 48 weeks
16200470|NCT01391013|Drug|Ritonavir|Oral administration of tablet ritonavir 100 mg once daily at the same time, within 30 minutes after food for 48 weeks
16200471|NCT01391013|Drug|2 nucleoside reverse transcriptase inhibitors (NRTIs)|2 NRTIs will be administered as per the package inserts.
16200472|NCT01391000|Procedure|LASER CO2|The therapy is performed with the patient sitting, place the unit high above the shoulder with the following indicators: through a pulsed 40 Hz, distance between device and patient 60 cm, 10x15 cm area of application, power 2W; energy between 10 and 15 J/cm2
16200473|NCT01391000|Procedure|TENS|"Transcutaneous Electrical Nerve Application of Stimulation occurs through the use of No. 3 channels (long head of biceps area (CLB), the supraspinatus muscle area, the area medial border of the scapula.
~Duration: Twenty (20) minutes, mpulsi: 70 microsec, frequency: 100 Hz, intensity: between 20 and 40 mA."
16200474|NCT01390961|Drug|alacaftadine and naphazoline HCl & pheniramine maleate|once a day
16200475|NCT01390948|Drug|Bevacizumab|10 milligrams per kilogram every 2 weeks during the study for up to 12 cycles, each cycle length of 28 days
16200476|NCT01390948|Radiation|Radiotherapy|Total dose of 54 Grey (Gy) units delivered in 30 daily fractions of 1.8 Gy over 6 weeks during the chemoradiation phase.
16200477|NCT01390948|Drug|Temozolomide (TMZ)|75 milligrams per square meter (mg/m^2) daily continuous starting concomitantly with the first radiation fraction and ending with the last radiation fraction for a maximum number of treatment days = 49 days. During the TMZ adjuvant treatment phase and for participants from YPC: TMZ (150 to 200 mg/m^2/day) x 12 cycles, 1st cycle 150 mg/m^2/days 1-5, escalated to 200 mg/m^2 on Days 1-5 from Cycle 2 onwards depending on the tolerance during the 1st cycle. Cycle length = 28 days.
16200480|NCT01390909|Drug|Anti-epileptic drug (AED)|Prescription claim for at least one AED including lamotrigine, tiagabine, pregabalin, ethosuximide, lacosamide, phenytoin, carbamazepine, valproic acid, felbamate, levetiracetam, zonisamide, primidone, oxcarbazepine, vigabatrin, phenobarbital, gabapentin, topiramate.
16200481|NCT01390896|Drug|Fondaparinux Sodium|
16200482|NCT01390883|Drug|Fondaparinux Sodium|
16200483|NCT01390870|Drug|5ARI or AB or Combination Therapy (5ARI + AB)|5ARI: Dutasteride or Finasteride; AB: Doxazosin, Silodosin, Tamsulosin, Terazosin, or Alfuzosin
16200484|NCT01390857|Drug|Valaciclovir|
16200485|NCT01390844|Drug|Boceprevir (BOC)|200 mg capsules, 800 mg three times daily by mouth
16200486|NCT01390844|Drug|Placebo to boceprevir|200 mg placebo capsules, 800 mg three times daily by mouth
16200487|NCT01390844|Drug|Peginterferon alfa-2b (PEG)|1.5 mcg/kg/week subcutaneously
16200488|NCT01390844|Drug|Ribavirin (RBV)|200 mg capsules, weight-based dosing 800 to 1400 mg/day by mouth divided twice daily
16200489|NCT01390844|Drug|Cross-Over Boceprevir Treatment|At Treatment Week 14, participants in the Placebo group with detectable HCV-RNA at Treatment Week 12 have the option to add boceprevir 800 mg three times daily to the PEG + RBV regimen for up to 32 weeks.
16200490|NCT01390831|Device|THERMOCOOL® Catheter|Catheter-based renal denervation
16200491|NCT01390818|Drug|MSC1936369B (pimasertib)|MSC1936369B (pimasertib) single dose capsule was administered at dose of 15 milligram (mg), 30 mg, 60 mg, 90 mg orally in successive 21-day cycles.Dose escalation was proceeded until Maximum Tolerated Dose (MTD) was reached. Once the MTD was reached, enrollment began in four disease-specific expansion cohorts at either the MTD or a lower dose recommended by the Safety Monitoring Committee. The four expansion cohorts enrolled subjects with Breast Cancer, Non-Small Cell Lung Cancer (NSCLC), Melanoma, and Colorectal Cancer.
16200492|NCT01390818|Drug|SAR245409 (PI3K and mTOR inhibitor)|SAR245409 (PI3K and mTOR inhibitor) capsule was administered orally at a dose of 30 mg, 50 mg, 70 mg and 90 mg in successive 21-day cycles. Dose escalation was proceeded until MTD was reached. Once the MTD was reached, enrollment began in four disease-specific expansion cohorts at either the MTD or a lower dose recommended by the Safety Monitoring Committee. The four expansion cohort enrolled subjects with Breast Cancer, NSCLC, Melanoma, and Colorectal Cancer.
16200493|NCT01390818|Drug|MSC1936369B (pimasertib)|MSC1936369B (pimasertib) capsule was administered twice daily orally at a dose of 60 mg and 45 mg in successive 21-day cycles. Dose escalation proceeded until MTD was reached. The maximum tolerated dose of MSC1936369B (pimasertib) was combined with a lower dose of SAR245409 (PI3K and mTOR inhibitor).
16200494|NCT01390818|Drug|SAR245409 (PI3K and mTOR inhibitor)|SAR245409 (PI3K and mTOR inhibitor) was administered twice daily orally at a dose of 30 mg and 50 mg in successive 21-day cycles. Dose escalation proceeded until MTD was reached. The maximum tolerated dose of SAR245409 (PI3K and mTOR inhibitor) was combined with a lower dose of MSC1936369B (pimasertib).
16200495|NCT01390805|Drug|Valaciclovir Hydrochloride.|
16200496|NCT01390792|Drug|Zanamivir hydrate|
16200497|NCT01390779|Device|SENSIMED Triggerfish|Contact lens-based device intended to continuously record the timing of relative changes in IOP for up to 24 hours
16200498|NCT01390766|Drug|Azathioprine|
16200499|NCT01390753|Dietary Supplement|Human donor milk|
16200500|NCT01390727|Device|Device-guided breathing (Resperate - InterCure, Israel)|After randomization, the patients allocated in this arm will be instructed to use a device-guided breathing, for 15 minutes per day during 8 weeks, with the aim to reduce the respiratory frequency to less than 10 breaths/min
16200501|NCT01390727|Other|Listen music|After randomization, the patients allocated in this arm will be instructed to listen to calm music for 15 minutes per day during 8 weeks
16200502|NCT01390714|Drug|E3710|"Arm A:
~E3710 40 mg→RPZ 10 mg→E3710 20 mg
~RPZ 10 mg→E3710 20 mg→E3710 40 mg
~E3710 20 mg→E3710 40 mg→RPZ 10 mg
~Crossover study of E3710 40 mg, E3710 20 mg, and PRZ 10 mg, once daily, for 5 days, oral administration."
16200503|NCT01390714|Drug|E3710|"Arm B:
~E3710 40 mg→E3710 80 mg→EPZ 40 mg
~E3710 80 mg→EPZ 40 mg →E3710 40 mg
~EPZ 40 mg→E3710 40 mg→E3710 80 mg
~Crossover study of E3710 40 mg, E3710 80 mg, and EPZ 40 mg, once daily, for 5 days, oral administration."
16200504|NCT01390701|Device|transcutaneous electrical nerve stimulation|30 min of bi-daily low-frequency transcutaneous electrical nerve stimulation on the upper extremities. Duration: 28+-4 days.
16200505|NCT01390701|Drug|felodipin|2,5mg of felodipin once daily. Duration: 28+-4 days.
16200506|NCT01390662|Dietary Supplement|Vitamin D3|one tablet of vitamin D3 70 µg pr. day, for 24 weeks.
16200507|NCT01390662|Dietary Supplement|placebo|one tablet of sugar pill pr. day, for 24 weeks.
16200508|NCT01390649|Biological|IgPro10|IgPro10 will be administrated by IV infusion either a single dose of 1 g/kg bw on 1 day or 2 doses of 1 g/kg bw on 2 days (2 g/kg bw total dose) dependent on the response to the first treatment.
16200509|NCT01390623|Drug|Ceftriaxone|"Patients will be included by investigators or coinvestigateurs, the day of consultation in the emergency adult department in Clermont-Ferrand city.
~The diagnosis of acute uncomplicated pyelonephritis is established in the emergency department based on the clinical, laboratory and imaging criteria."
16200510|NCT01390597|Genetic|DNA analysis|
16200511|NCT01390597|Genetic|cytogenetic analysis|
16200512|NCT01390597|Genetic|gene mapping|
16200513|NCT01390597|Genetic|mutation analysis|
16200514|NCT01390597|Genetic|polymerase chain reaction|
16200515|NCT01390597|Other|laboratory biomarker analysis|
16200516|NCT01390584|Drug|Doxorubicin|IV
16200517|NCT01390584|Drug|Bleomycin|IV
16200518|NCT01390584|Drug|Vinblastine|IV
16200519|NCT01390584|Diagnostic Test|PET|fludeoxyglucose F 18 Imaging exam
16200520|NCT01390584|Radiation|INRT|selective external radiation therapy
16200521|NCT01390584|Drug|Dacarbazine|IV
16200522|NCT01390584|Drug|Etoposide|IV
16200523|NCT01390584|Drug|Cyclophosphamide|May be given orally, IV push, or by IV infusion
16200524|NCT01390584|Drug|Vincristine|IV
16200525|NCT01390584|Drug|Procarbazine|PO
16200526|NCT01390584|Drug|Prednisone|PO
16200527|NCT01390571|Drug|olaparib|
16200528|NCT01390571|Drug|temozolomide|
16200529|NCT01390571|Genetic|gene expression analysis|
16200530|NCT01390571|Genetic|protein expression analysis|
16200943|NCT01387321|Drug|BYL719|
16200536|NCT01390558|Procedure|custom orthotics|Orthotics are fabricated uniquely for each patient and use molds or casts of their foot as the template. They are fabricated by a licensed orthotist. There is no device or brand name other than custom orthotics.
16200537|NCT01390545|Drug|Veltuzumab|administered once weekly (days 1, 8, 15 and 22) by subcutaneous injection
16200538|NCT01390532|Device|3D Blood-Pool Gated SPECT (BPGS) with a new designed cardiac imaging camera (DSPECT, Spectrum Dynamics®, Ceasaria, Israel)|"Sequential 5 min Gated blood pool D-SPECT acquisition at rest and during last stage of dobutamine and atropin infusion (>85% PHR).
~Rest and stress left ventricular ejection fraction, phase standard deviation and entropy will be determined using a fully automatic commercial software (QBS, Cedars-Sinai, Los Angeles, CA)."
16200539|NCT01390519|Other|everolimis|
16200540|NCT01390506|Drug|Sodium-selenite|Di-sodium-selenite-pentahydrate (Na 2SeO3.5H2O) in 0,9% sodium chloride is administered intravenously at a does of 3000µg on day 0, 2000µg on day 1 and 2 and at a dose of 1000µg per day on day 3-6.
16200541|NCT01390506|Drug|Placebo|0,9% sodium chloride is administered intravenously
16200542|NCT01390493|Behavioral|neurofeedback training|training of individual alpha frequency, 10 sessions, each 15 min
16200543|NCT01390480|Drug|Cholecalciferol|weekly dose (based on 70 IU/kg bodyweight/day) orally
16200544|NCT01390467|Drug|Cantab®|Randomized study, double-blind, crossover, controlled versus placebo.
16200545|NCT01390454|Procedure|Ultrasound of the elbow 1, days 7 to 15|The primary endpoint is evaluated a first time via an ultrasound exam.
16200546|NCT01390454|Procedure|Ultrasound of the elbow 2, days 7 to 15|The primary endpoint is evaluated a second time by a second practitioner.
16200547|NCT01390454|Procedure|Ultrasound of the elbow 3, days 45 to 90|A third ultrasound is performed only on tennis elbow patients between days 45 and 90.
16200548|NCT01390441|Biological|MK-8808|MK-8808 500 mg/m^2 administered by IV on Day 1 and Day 15 or MK-8808 1000 mg administered by IV at Week 54 and Week 56
16200549|NCT01390441|Biological|MabThera® (rituximab)|MabThera® 500 mg/m^2 or 1000 mg administered by IV on Day 1 and Day 15
16200550|NCT01390441|Drug|Methotrexate|Methotrexate 10-25 mg administered orally, SC, or IM as a weekly stable dose
16200551|NCT01390441|Biological|Rituxan® (rituximab)|Rituxan® 1000 mg administered by IV on Day 1 and Day 15
16200552|NCT01390441|Drug|Methylprednisolone|Methylprednisolone 100 mg administered IV before initiation of each infusion as pre-medication to reduce the incidence and severity of infusion reactions
16200553|NCT01390441|Drug|Acetaminophen|Acetaminophen 1000 to 1350 mg administered orally before initiation of each infusion as pre-medication to reduce the incidence and severity of infusion reactions
16200554|NCT01390441|Drug|Loratadine|Loratidine 10 mg administered orally before initiation of each infusion as pre-medication to reduce the incidence and severity of infusion reactions
16200555|NCT01390428|Drug|Grazoprevir|Part 1: oral morning dose of 200 mg daily for 10 days Part 2: oral morning dose of 100 mg daily for 10 days Part 3: oral morning dose of 50 mg daily for 10 days
16200556|NCT01390402|Drug|Fludarabine|40 mg/m2 intravenous over one (1) hour on each of four (4) consecutive days, Days -13 to -10.
16200557|NCT01390402|Drug|Busulfan|130 mg/ m2 by vein for 2 doses on Days -11 to -10.
16200558|NCT01390402|Procedure|NK cell infusion:|Natural killer cell infusion will be administered by vein on Day -8.
16200559|NCT01390402|Drug|Interleukin-2|0.5 million units subcutaneously daily for 5 days on Day -8 to day -4.
16200560|NCT01390402|Drug|Anti-Thymocyte Globulin|2.5 mg/kg by vein for 3 doses on Days -3 to -1.
16200561|NCT01390402|Procedure|Allogeneic related Stem Cell Transplant|Allogeneic related stem cell transplant by vein on day 0.
16200562|NCT01390402|Drug|Tacrolimus|Starting dose of 0.015 mg/kg (ideal body weight) as a 24 hour continuous infusion daily adjusted to achieve a therapeutic level of 5-15 ng/ml.
16200563|NCT01390402|Drug|Methotrexate|5 mg/m2 by vein Days 1, 3 and 6 post transplant.
16200564|NCT01390402|Drug|G-CSF|5 mcg/kg/day subcutaneously beginning on Day + 7, and continuing until the absolute neutrophil count (ANC) is > 500 x 10/L for 3 consecutive days.
16200565|NCT01390389|Drug|Coenzyme Q10|"Single pill consists of 400 mg and is delivered PO.
~CoQ10 dosing guidelines:
~Visit 1 (baseline) start at 400mg once a day for two weeks
~Visit 2 (within 7 days of baseline visit) increase to 800 mg once a day for two weeks
~The dosage of CoQ10 can be titrated in a more gradual manner depending on clinical response and tolerability of the medication, but cannot be titrated any more rapidly than the schedule above."
16200566|NCT01390376|Drug|DAAOI-1|DAAOI-1 1g
16200567|NCT01390376|Drug|DAAOI-1|DAAOI-1 2g
16200568|NCT01390376|Drug|placebo|starch pill
16200569|NCT01390363|Other|Parent Only Phone Call|A telephone call will be made to the parent/guardian informing them that the adolescent has not received one or more vaccines (Td/Tdap in the past 5 years, the MCV4 vaccine, or the 2nd VZV vaccine). The phone call will include a brief informational statement about the vaccine(s) that the adolescent has not yet received. Up to 4 telephone calls will be attempted. As part of the phone call, we will offer to schedule an appointment for the adolescent to receive the missing immunization(s). We will also ask them to mail or fax to the Adolescent/Young Adult Medicine clinic records of immunizations given at other sites.
16200570|NCT01390363|Other|Parent and Adolescent Phone Call|A telephone call will be made to the parent/guardian informing them that the adolescent has not received one or more vaccines (Td/Tdap in the past 5 years, the MCV4 vaccine, or the 2nd VZV vaccine). The phone call will include a brief informational statement about the vaccine(s) that the adolescent has not yet received. Up to 4 telephone calls will be attempted. As part of the phone call, we will offer to schedule an appointment for the adolescent to receive the missing immunization(s). We will also ask them to mail or fax to the Adolescent/Young Adult Medicine clinic records of immunizations given at other sites. We will also ask permission to speak with the adolescent as well, and if granted, will make up to 4 phone calls to the adolescent to convey the same message.
16200571|NCT01390350|Drug|Canakinumab|150mg subcutaneous injections on day 0
16200572|NCT01390350|Drug|Placebo|150mg subcutaneous injections on day 0
16200573|NCT01390337|Drug|AC220|Oral Liquid
16200574|NCT01390337|Drug|daunorubicin|Intravenous Infusion
16200575|NCT01390337|Drug|cytarabine|Intravenous Infusion
16200576|NCT01390324|Drug|Fixed-dose combination of naratriptan+naproxen|Tablets containing naratriptan 2,5 mg + naproxen 500 mg
16200580|NCT01390311|Drug|Pre-DLI Salvage Chemotherapy|At the discretion of the treating physician
16200581|NCT01390311|Biological|Donor Leukocyte Infusion (DLI)|
16200582|NCT01390298|Other|Observational|Observational study only
16200583|NCT01390285|Device|Transcutaneous electric nerve stimulation|The subjects that enter the TENS-group will be asked to apply the TENS therapy for at least 40 minutes continuously per day. The parameters of the current will not be changed during the study (pulse: 250 µsec; internal frequency: 100Hz; burst frequency 3 Hz; intensity: until an unpleasant but not painful sensation is acquired).
16200584|NCT01390285|Device|sham transcutaneous electrical nerve stimulation|The patients that are assigned to the sham TENS will receive an inactive placebo TENS therapy using a nonfunctional unit that appears to work but provides no stimulus.
16200585|NCT01390272|Behavioral|Booster/ low resource|A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months.
16200586|NCT01390272|Behavioral|Booster/ low resource|A LPN will provide behavioral support telephone calls that do not include goal setting and directed problem solving every two months.
16200587|NCT01390272|Behavioral|Medium/Level 1 resource intensity|Monthly tailored RN delivered calls + home BP monitoring.
16200588|NCT01390272|Behavioral|High/Level 2 resource intensity|Pharmacist delivered telephone behavioral self-management support + Home BP monitoring with feedback to pharmacist + Algorithmic medication changes directed by pharmacist (with physician backup).
16200589|NCT01390259|Device|Open-Loop|This admission was to assess the subjects' level of glucose control and created a base to compare the performance of the closed-loop system. Subjects monitored their own blood glucose values and administer their basal/bolus as they would at home. Otherwise, the admission remained the same as in the closed-loop admission (i.e. meals, exercise, etc...).
16200590|NCT01390259|Device|Closed-Loop|In this study, the researchers compared the management of diabetes during physical activity and meals with the closed-loop system developed at the University of Virginia. This system uses two DexComTM Seven Continuous Glucose Monitor, a computer containing an investigational control algorithm (well-defined instructions that are expressed in mathematical equations), and an OmniPod Insulin Management System, a portable subcutaneous (under the skin) insulin pump. During the closed-loop admission, the computer based algorithm used CGM values to make recommendations of insulin treatment. The study included a challenge to the insulin management system with meals and mild exercise, so as to demonstrate its capacity to avoid large glucose excursion with changing metabolic state.
16200591|NCT01390246|Drug|Bupropion SR|Bupropion SR 150 mg tablet
16200592|NCT01390246|Behavioral|Smoking Cessation Counseling|35-min counseling by trained research nurse
16200593|NCT01390246|Drug|Placebo|Matching Bupropion SR placebo tablet
16200594|NCT01390233|Drug|Prepidil Gel|Pre-induction cervical ripening using dinoprostone gel in the vagina.
16200595|NCT01390233|Device|Urinary Balloon Catheter|Pre-induction cervical ripening using a urinary balloon catheter device.
16200596|NCT01390233|Other|Combined Urinary Catheter & Prepidil Gel|Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment.
16200597|NCT01390220|Drug|USL261|
16200598|NCT01390220|Drug|Placebo|
16200599|NCT01390207|Other|16mm triggering|"Final oocyte maturation will be achieved by administration of 10.000 IU of hCG (Pregnyl®). Randomization will be into 2 groups:
~• Group A (early hCG group): hCG will be administrated as soon as ≥ 3 follicles ≥ 16mm were present on ultrasound."
16200600|NCT01390181|Drug|Cozaar|Angiotensin II Receptor Blocker
16200601|NCT01390168|Behavioral|Tailored Internet-administrated CBT-Treatment|"This intervention contains up to 6-10 text-based self-help modules in which 4 modules are fixed (the first three and the last) and the rest are prescribed following the diagnostic telephone interview. These modules contain material on panic disorder, social phobia, stress management, assertiveness training, concentration, relaxation among other things."
16200602|NCT01390168|Behavioral|Waitlist|active waitlist
16200603|NCT01390155|Procedure|Measurement of coronary collateral flow index|One-minute balloon occlusion of the proximal left anterior descending coronary artery inducing a controlled short-time ischemic condition of a part of the myocardium and simultaneous evaluation of collateral flow.
16200604|NCT01390155|Procedure|Measurement of coronary collateral flow index|One-minute balloon occlusion of the proximal left circumflex artery inducing a controlled short-time ischemic condition of a part of the myocardium and simultaneous evaluation of collateral flow.
16200605|NCT01390155|Procedure|Measurement of coronary collateral flow index|One-minute balloon occlusion of the proximal right coronary artery inducing a controlled short-time ischemic condition of a part of the myocardium and simultaneous evaluation of collateral flow.
16200606|NCT01390155|Procedure|Measurement of coronary collateral flow index|One-minute balloon occlusion of the target vessel (the vessel which shows a significant stenosis and accordingly requires a therapeutical intervention by balloon angioplasty and stenting) inducing a controlled short-time ischemic condition of a part of the myocardium and simultaneous evaluation of collateral flow.
16200607|NCT01390142|Procedure|Control|Deflated blood pressure cuff placed on upper arm for 30min
16200608|NCT01390142|Procedure|RIPer|Blood pressure cuff placed on upper arm and inflated to 200 mmHg for 5 min and then deflated for 5 min. This cycle is initiated as soon as possible after patient admission in the cathlab and repeated 3 times in total.
16200609|NCT01390142|Procedure|RIPer + IPost|Blood pressure cuff placed on upper arm and inflated to 200 mmHg for 5 min and then deflated for 5 min. This cycle is initiated as soon as possible after patient admission in the cathlab and repeated 3 times in total. Within the first minute of re-established coronary flow by primo-stenting, the same balloon is re-inflated for 1 min and then deflated for 1min. This procedure of balloon inflation/deflation is repeated 4 times in total.
16200610|NCT01390129|Procedure|Control|Deflated blood pressure cuff placed on upper arm for 30min
16200611|NCT01390129|Procedure|Remote ischemic preconditioning|Blood pressure cuff placed on upper arm and inflated to 200 mmHg for 5 min and then deflated for 5 min. This cycle is initiated before aortic clamping and repeated 3 times in total
16200612|NCT01390116|Dietary Supplement|Aged garlic extract|2 aged garlic extract capsules taken twice daily
16200613|NCT01390116|Dietary Supplement|AGE|encapsulated aged garlic extract, 4 capsules per day, 2.56g/day
16200944|NCT01387308|Drug|Fostamatinib|Oral tablets, 50 mg x 2, single dose
16200614|NCT01390103|Other|Assessment following hip injection|Assessment to evaluate the effect of the hip injection on biomechanics.
16200615|NCT01390077|Drug|Nitisinone|Taken orally. Supplied as a 2mg tablet. The starting dose is 2 mg once daily.
16200616|NCT01390064|Biological|Vaccination with Mimotope P10s-PADRE/MONTANIDE ISA 51 VG|All research participants will receive the Mimotope P10s-PADRE/MONTANIDE ISA 51 VG vaccine via subcutaneous (SC) injection following the schedule
16200617|NCT01390051|Drug|Innohep (Tinzaparin)|Dose: 4,500 IU daily in half of the study populationrandomised to treatment
16200618|NCT01390051|Drug|tinzaparin|Dose 4,500 IE daily
16200619|NCT01390038|Device|Simpliciti™ Shoulder System|Total shoulder arthroplasty system
16200620|NCT01390025|Biological|TCN-032|TCN-032 is a human monoclonal antibody that specifically binds to a conserved epitope of the amino-terminal extracellular domain (M2e) of the influenza virus matrix protein 2 (M2). The drug is intended for use as an antiviral agent for the treatment of disease caused by type A influenza viruses. Treatments within the study will consist of single ascending dose-escalation ranging from 1 to 40 mg/kg.
16200621|NCT01390025|Biological|Placebo|Placebo - 0.9% Sodium Chloride for Injection, USP
16200622|NCT01390012|Drug|Dexamethasone tablet 6 mg|Dexamethasone tablet 6 mg
16200623|NCT01390012|Drug|Dexamethasone injection 4 mg|Dexamethasone injection 4 mg
16200624|NCT01389999|Other|Questionnaires|Each patient is asked to fill out several questionnaires: a french version of the BBQ, as well as the FABQ, the TAMPA score, and the Québec questionnaire, the Dallas score, the HAD score and a visual analog scale for pain.
16200625|NCT01389986|Behavioral|Gum chewing|Gum chewing (30 minutes in duration each time, 4 times/days at the usual time of meal, until the first flatus) in addition to conventional postoperative feeding schedule
16200626|NCT01389973|Drug|ustekinumab 90 mg|Subcutaneous injections of ustekinumb 90 mg at Weeks 0 and 4 and every 8 weeks until the dose for the Long-Term Extension has been selected then every 8 weeks through Week 196 with the selected dose.
16200627|NCT01389973|Drug|ustekinumab 45 mg|Subcutaneous injections of ustekinumb 45 mg at Weeks 0 and 4 and every 8 weeks until the dose for the Long-Term Extension has been selected then every 8 weeks through Week 196 with the selected dose.
16200628|NCT01389973|Drug|ustekinumab 180 mg|Subcutaneous injections of ustekinumb 180 mg at Weeks 0 and 4 and every 8 weeks until the dose for the Long-Term Extension has been selected then every 8 weeks through Week 196 with the selected dose.
16200629|NCT01389973|Drug|Placebo|Subcutaneous injections of placebo at Weeks 0 and 4 and every 8 weeks until the dose for the Long-Term Extension has been selected then every 8 weeks through Week 196 with the selected dose.
16200630|NCT01389934|Drug|levo-bupicaine|Women of this group will be infused L-bupivacaine 0.50% 2 ml / h for 48h after intervention
16200631|NCT01389934|Drug|Placebo|Women of this group be infused saline 2 ml / h for 48h.
16200632|NCT01389921|Other|Electroencephalography|Standard electroencephalography investigation according to the ICS standard Current recording of latency and amplitude of evoked potentials
16200633|NCT01389908|Drug|olanzapine|Patients will receive doses within the range of 280 mg to 405mg OP Depot, according the physician's judgment, on a 3-week interval.
16200634|NCT01389895|Drug|AMG 557|AMG 557 (210 mg) or (140 mg ) will be administered as subcutaneous injections in the anterior abdomen of the subjects. Twelve subjects will be randomized to receive AMG 557. Beginning on Day 1, subjects will receive either 210 mg AMG 557 or 140 mg AMG 557 once weekly for 3 weeks on Day 1, Day 8, and Day 15 and following with 6 additional doses of AMG 557 every other week on Day 29, Day 43, Day 57, Day 71, Day 85, and Day 99. Subjects will be followed out to Day 253 for safety, efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) assessments.
16200635|NCT01389895|Drug|AMG 557 Placebo|AMG 557 Placebo (210 mg) or (140 mg )will be administered as subcutaneous injections in the anterior abdomen of the subjects. Twelve subjects will be randomized to receive placebo. Beginning on Day 1, subjects will receive placebo once weekly for 3 weeks on Day 1, Day 8, and Day 15 and following with 6 additional doses of placebo every other week on Day 29, Day 43, Day 57, Day 71, Day 85, and Day 99. Subjects will be followed out to Day 253 for safety, efficacy, pharmacokinetic (PK) and pharmacodynamic (PD) assessments.
16200636|NCT01389882|Procedure|neurally adjusted ventilatory assist (NAVA) ventilator mode|Neurally adjusted ventilatory assist (NAVA) utilizes the electrical activity of the diaphragm (EAdi) to trigger and cycle-off breaths, and therefore presents a means of bypassing the ventilator circuit, and the inherent delays with pneumatic triggering. This is a processed signal, which is not artificially influenced by changes in muscle length, chest wall configuration, and/or lung volume. It represents the summation of muscle motor unit recruitment and/or firing rate, and correlates with phrenic nerve activity. In this mode, the amount of support pressure is coupled with the magnitude of the EAdi. The proportion of support pressure to EAdi (NAVA level) is adjustable.
16200637|NCT01389869|Biological|Sniffing emotional tears|A band-aid soaked 100μl of emotional tears will be applied just below nostrils.
16200638|NCT01389869|Biological|Sniffing trickled saline|A band-aid soaked 100μl of trickled saline will be applied just below nostrils.
16200639|NCT01389869|Biological|Sniffing fasting plasma|A band-aid soaked 100μl of own fasting plasma will be applied just below nostrils.
16200640|NCT01389869|Biological|Sniffing postprandial plasma|A band-aid soaked 100μl of own postprandial plasma will be applied just below nostrils.
16200641|NCT01389856|Drug|Bosentan|2 mg/kg of weight at birth twice daily (b.i.d); quadrisectable 32 mg tablet of bosentan dispersed in sterile water and administered by nasogastric or orogastric tube.
16200642|NCT01389856|Drug|Matching placebo|twice daily (b.i.d); quadrisectable 32 mg tablet of matching placebo dispersed in sterile water and administered by nasogastric or orogastric tube.
16200643|NCT01389830|Behavioral|Telephone Survey|Telephone interviews (survey) at baseline taking approximately 30-40 minutes to complete; follow-up monthly surveys for cancer patients take 20-30 minutes to complete, follow ups until 12 months or death.
16200644|NCT01389817|Device|Near-infrared light-emitting diode (NIR-LED) therapy (Med Light 630 PRO (Medical Devices Inc.))|Subjects will be exposed to light emitted from a Med Light 630 PRO (Medical Devices Inc.) at a wavelength of 630 nm (+/-15nm) with an exposure of 4 J/cm2. This is accomplished by applying the 50 mW/cm2 LED-generated light to the closed study eye for 80 seconds. Treatments involve application of the LED-generated light for 80 seconds, twice daily.
16200645|NCT01389791|Drug|magnesium sulfate|Patients in this group receive intravenous MgSO4 50mg/kg before administration of rocuronium (induction dose).
16200646|NCT01389791|Drug|priming|Patients in this group receive 0.06mg/kg of rocuronium before administration of 0.54mg/kg of rocuronium.
16200647|NCT01389791|Drug|magnesium sulfate and priming|Patients in this group receive MgSO4 50mg/kg and 0.06mg/kg of rocuronium before administration of 0.54mg/kg of rocuronium.
16200648|NCT01389778|Drug|Metformin ER|Metformin ER 1500 mg for 12 weeks
16200649|NCT01389778|Drug|Metformin|
16200650|NCT01389765|Drug|LY2216684|Administered orally
16200651|NCT01389752|Drug|LY2216684|Administered orally
16200652|NCT01389752|Drug|Activated Charcoal|Administered orally
16200653|NCT01389739|Other|Multi-faceted intervention to improve continuity of care|Periodic exchange of information between FP and oncology team and systematic appointments with FP at 3-month interval
16200654|NCT01389726|Behavioral|Behavioral Parent Training|Triple-P program involves 11 weeks of ongoing group support with contact one time per week with trained group leaders
16200655|NCT01389726|Behavioral|Cognitive Behavioral Therapy|Support group based intervention involving sessions one time per week for 11 weeks with 9-12 grandmothers, 1 trained professional group leader, and 1 trained peer leader
16200656|NCT01389726|Behavioral|Psychosocial-Informational support|Standard of care normally provided to custodial grandparents. Involves providing information and support in the context of a weekly group meeting with 9-12 grandparents, 1 professional group leader & 1 peer leader over the course of 11 weeks.
16200657|NCT01389713|Drug|Clomifene Citrate|3x50 mg die for 5 days from day 3 to day 7 of the menstrual cycle
16200658|NCT01389713|Drug|GnRH analog and recombinant human FSH|daily subcutaneous 0.1 mg decapeptyl from day 1-2 of the menstrual cycle and recombinant human FSH 450 IU/die from day 3.
16200659|NCT01389700|Drug|SAR279356|"Pharmaceutical form: solution for infusion
~Route of administration: intravenous infusion"
16200660|NCT01389700|Drug|placebo|"Pharmaceutical form: solution for infusion
~Route of administration: intravenous infusion"
16200661|NCT01389687|Biological|Inactive Poliovirus Vaccine|0.5 mL, Subcutaneous
16200662|NCT01389674|Procedure|2D-strain echo|"2D-strain-analysis with elevation of the radial and circumferential strain and strain rate parameter(systolic and diastolic)occurs through the echocardiography.
~Comparison of the echocardiography and the MRI-vitality data, calculation of a cut out of vision value of a vitality diagnosis with the help of 2D-strain-analysis."
16200663|NCT01389661|Biological|MSV treatment|Autologous maxillary bone marrow mesenchymal stem cells (MSV-H) collected from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV)
16200664|NCT01389648|Other|Pre Operative|Pre operative chest physiotherapy treatment
16200665|NCT01389622|Other|acupuncture|National Acupuncture Detoxification Association (NADA) points + digital pressure
16200666|NCT01389622|Other|acupuncture|random points + digital pressure
16200667|NCT01389609|Drug|Doxazosin 4 mg Japanese marketed IR tablet|Immediate release tablet, 4 mg, single dose
16200668|NCT01389609|Drug|Doxazosin 4 mg ODT with water|Orally-disintegrating Tablet , 4 mg, single dose with water
16200669|NCT01389609|Drug|Doxazosin 4 mg ODT without water|Orally-disintegrating Tablet , 4 mg, single dose without water
16200670|NCT01389596|Drug|Pregabalin add-on therapy|Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period.
16200671|NCT01389596|Drug|Pregabalin add-on therapy|Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period.
16200672|NCT01389596|Drug|Pregabalin add-on therapy|Subjects will be randomized to receive a fixed dose of either placebo, pregabalin Level 1 (maximum 150 mg/day) or pregabalin Level 2 (maximum 600 mg/day) in a 1:1:1 ratio, in addition to the subjects current AED medication regimen. Either capsules or oral liquid form will be administered, depending on subjects preference and ability to swallow capsules, in two equally divided daily doses. The study will have an 8 week baseline period; a 2 week dose escalation period; a 9 week dose maintenance period; and a 1 week dose taper period.
16200673|NCT01389583|Drug|AUY922|70 mg/m2 60-min i.v. infusion weekly
16200674|NCT01389570|Procedure|Acupressure wrist band|Use of acupressure wristband during surgery Manufacturer; Pinnacle Ind Ltd, Rm 831 Thriving Ind Ctr, 26-38 Sha Tsui Rd, Tsuen Wan, Hong Kong
16200675|NCT01389557|Drug|Dihydroartemisinin-piperaquine with primaquine|"P. falciparum : Treated with fixed doses of 40 mg dihydroartemisinin and 320 mg piperaquine based on weight for 3 days (D0, D1 and D2) with max dose of 1 x 3 tablets for patients weighing ≥ 41 kg; 1 x 2 tablets for patients weighing 31 - 40 kg, 1 x 1.5 tablets for patients weighing 18 - 30 kg, and 1 X 1 tablet for patients with body weight of 11 - 17 kg. A single dose PQ of 0.75 mg/kg BW was provided on Day-3 using 15 mg base PQ tablets. The maximal dose was 3 tablets for subjects weighing ≥ 60 kg. The dose range for subjects weighing 10 - 13 kg was 0.5 tablet; 14 - 18 kg was 0.75 tablet; 19 - 23 kg was 1 tablet, 24 -30 kg was 1.5 tablet; 31 - 40 kg was 2 tablets; 41- 49 kg was 2.25 tablet; 50 - 59 kg was 2.5 tablet and ≥ 60 kg was 3 tablets.
~P. vivax: DHP (3 days) + primaquine (14 days)"
16200676|NCT01389544|Drug|danoprevir|200 mg daily (100 mg q12h) orally, Days 1-10
16200677|NCT01389544|Drug|methadone|stable maintenance therapy: 20-120 mg daily single oral morning dose
16200678|NCT01389544|Drug|ritonavir|200 mg daily (100 mg q12h) orally, Days 1-10
16200679|NCT01389531|Procedure|Rigid bronchoscopy|The HCPA-1 silicone stent available in the following dimensions (diameter x length in mm): 9x30, 9x50, 11x30, 11x50, 13x30, 13x50, 14x30, 14x50, 16x50, 16x70, 18x50 and 18x70 will be inserted through rigid bronchoscopy in patients who presented the criteria to participate in the study.
16200680|NCT01389518|Drug|Active|1 capsule de active (fixed combination of acetaminophen, chlorpheniramine and phenylephrine) administered in four 4-hour period of wakefulness in between at 07:00 and 23:00 (five daily doses) for two or three consecutive days
16200681|NCT01389518|Drug|Placebo|1 capsule administered in four 4-hour period of wakefulness in between at 07:00 and 23:00 (five daily doses) for two or three consecutive days
16200682|NCT01389505|Procedure|Panretinal photocoagulation|Three episodes of panretinal photocoagulation with one week of interval
16200683|NCT01389505|Procedure|Procedure: Panretinal Photocoagulation (PRP) Drug: Intravitreous injection of Bevacizumab|Intravitreous injection of Bevacizumab 1 week before and the other at the same day of the third episode of PRP
16200684|NCT01389492|Other|frozen meat cutlets meal|250 g of meat cutlets
16200685|NCT01389492|Other|meat meals|250 g of meat meal for 4 days
16200686|NCT01389479|Biological|Fluviral™|Intramuscular, single dose
16200687|NCT01389479|Biological|Fluzone®|Intramuscular, single dose
16200688|NCT01389466|Biological|Step 1|Investigational Product : MG1109 Dose : Cohort 1 : 0.125 mL Cohort 2 :0.25 mL Cohort 3 :0.5 mL Cohort 4 :1.0 mL intramuscularly injection, twice at an interval of 21 days
16200689|NCT01389466|Biological|Step 2|Investigational Product : MG1109 Dose : Cohort 1 :0.5 mL Cohort 2 :1.0 mL intramuscularly injection, twice at an interval of 21 days
16200690|NCT01389453|Procedure|stem cell transplantation|Patients accept a treatment course stem cell transplantation, including one time stem cell transplantation through intravenous injection way at the 10-21th day of cerebral hemorrhage, and the 7-14th day of cerebral infarction incidence; the second time transplantation through lumbar puncture way at the 7th day after the First time transplantation.
16200691|NCT01389440|Drug|Gemcitabine and Erlotinib|Administration of gemcitabine (300mg/m2/weekly)with Erlotinib (100 mg/daily) and radiotherapy (45 Gy/daily) after a period of infusion with a full dose of Gemcitabine (1.000mg/m2/weekly) and Erlotinib (100 mg/daily)
16200692|NCT01389427|Drug|Torisel dose 15 mg and R-CHOP|Torisel in association with Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (R-CHOP) administered every 3 weeks (21 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).
16200693|NCT01389427|Drug|Torisel dose 15 mg and R-FC|Torisel in association with Rituximab-Fludarabine-Cyclophosphamide (R-FC) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).
16200694|NCT01389427|Drug|Torisel dose 15 mg and R-DHA|Torisel in association with Rituximab-Aracytine (high dose)-Dexamethasone (R-DHA) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).
16200695|NCT01389427|Drug|Torisel dose 25 mg and R-CHOP|Torisel in association with Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (R-CHOP) administered every 3 weeks (21 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).
16200696|NCT01389427|Drug|Torisel dose 50 mg and R-CHOP|Torisel in association with Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (R-CHOP) administered every 3 weeks (21 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).
16200697|NCT01389427|Drug|Torisel dose 75 mg and R-CHOP|Torisel in association with Rituximab-Cyclophosphamide-Doxorubicin-Vincristine-Prednisone (R-CHOP) administered every 3 weeks (21 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).
16200698|NCT01389427|Drug|Torisel dose 25 mg and R-FC|Torisel in association with Rituximab-Fludarabine-Cyclophosphamide (R-FC) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).
16200699|NCT01389427|Drug|Torisel dose 50 mg and R-FC|Torisel in association with Rituximab-Fludarabine-Cyclophosphamide (R-FC) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).
16200700|NCT01389427|Drug|Torisel dose 75 mg and R-FC|Torisel in association with Rituximab-Fludarabine-Cyclophosphamide (R-FC) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).
16200701|NCT01389427|Drug|Torisel dose 25 mg and R-DHA|Torisel in association with Rituximab-Aracytine (high dose)-Dexamethasone (R-DHA) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).
16200702|NCT01389427|Drug|Torisel dose 50 mg and R-DHA|Torisel in association with Rituximab-Aracytine (high dose)-Dexamethasone (R-DHA) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).
16200703|NCT01389427|Drug|Torisel 75 mg and R-DHA|Torisel in association with Rituximab-Aracytine (high dose)-Dexamethasone (R-DHA) administered every 4 weeks (28 days) for 6 cycles for patients in relapsed/refractory Mantle Cell Lymphoma (MCL).
16200704|NCT01389414|Drug|Panitumumab plus GEMOX chemotherapy|panitumumab 6 mg/kg will be administered over 60 minute +/- 15 minutes on day 1 followed by Gemcitabine 1000mg/sqm administered by intravenous infusion as 1-hour infusion on day 1 of each cycle. Oxaliplatin 100mg/sqm will be administered by intravenous infusion as 2-hour infusion on day 2 of each cycle.
16200705|NCT01389414|Drug|GEMOX chemotherapy|Gemcitabine 1000mg/sqm will be administered by intravenous infusion as 1-hour infusion on day 1 of each cycle. Oxaliplatin 100mg/sqm will be administered by intravenous infusion as 2-hour infusion on day 2 of each cycle.
16200706|NCT01389401|Drug|omeprazole|omeprazole 40 mg twice a day for 16 weeks; dietary and lifestyle changes
16200707|NCT01389388|Drug|Rosuvastatin|All the patients who have signed the informed consent will after they have had performed a MCT and possibly SCC with an IVUS, will be give Rosuvastatinuntill their LDL level has reached 1.6-1.8 mmol/l. The objective is that all the participants should have reached 1.6-1.8 mmol/l 3 months after the start of the study. The participants will remain on Rosuvastatin medication for a total of 18 months.
16200708|NCT01389375|Device|FemoSeal®|Closure device for femoral artery access closure
16200709|NCT01389375|Device|ExoSeal®|Closure device for femoral artery access closure
16200710|NCT01389375|Other|Manual compression|Conventional manual compression
16200711|NCT01389362|Drug|Chinese herbal medicine (Radix Rehmanniae and Radix Astragali)|2 sachets to be taken daily
16200712|NCT01389362|Drug|Placebo comparator|2 sachets to be taken daily
16200713|NCT01389349|Other|Acupuncture|Battlefield acupuncture protocol
16200714|NCT01389349|Other|Sham Control|Sham control acupuncture
16200715|NCT01389323|Drug|Daclatasvir|Tablet, Oral, 60 mg, once daily, 24 weeks
16200716|NCT01389323|Drug|Peg-Interferon Alfa-2a|Syringe, Subcutaneous Injection, 180 μg, Once weekly, 24 or 48 weeks depending on response
16200717|NCT01389323|Drug|Ribavirin|Tablet, Oral, 1000 or 1200 mg based on weight, Twice daily, 24 or 48 weeks depending on response
16200718|NCT01389297|Behavioral|SMART Recovery face-to-face meetings|Attending these meetings at least weekly in frequency
16200719|NCT01389297|Behavioral|Overcoming Addictions web application|Logging into and using the web application at least weekly during the course of the study
16200720|NCT01389284|Drug|Naproxen Sodium ER (BAYH6689)|660 mg Naproxen Sodium extended release tablet, orally administered once daily for 24 hours
16200721|NCT01389284|Drug|Naproxen Sodium IR (Aleve, BAYH6689)|220 mg Naproxen Sodium instant release tablet, orally administered 3 times daily (TID) for 24 hours
16200722|NCT01389284|Drug|Naproxen Sodium ER Placebo|Matching placebo of 660 mg Naproxen Sodium ER for 24 hours
16200723|NCT01389284|Drug|Naproxen Sodium IR Placebo|Matching placebo of 220 mg Naproxen Sodium IR (Aleve) for 24 hours
16200724|NCT01389271|Drug|Ventavis inhaled (Iloprost, BAYQ6256)|Since this study is an observational, inhaled iloprost dosage and frequency for each patient will be prescribed by physicians as medically required.
16200725|NCT01389258|Device|OsseoSpeed™ TX|OsseoSpeed™ TX narrow implants (diameter 3 mm) of lengths 11-15 mm
16200726|NCT01389245|Device|OsseoSpeed™ TX|OsseoSpeed™ TX implants of lengths 8-17 mm
16200727|NCT01389232|Device|SeriScaffold® Surgical Scaffold|A CE Marked, 510(k) cleared, knitted, multi-filament, bioengineered, silk mesh indicated for use as a transitory scaffold for soft tissue support and repair
16200728|NCT01389219|Other|Intervention|"A comprehensive package of intervention will be developed for the mothers and newborn infants which will be comprised of;
~Provision of postpartum maternal and immediate newborn care, including postpartum visit, maternal nutrition supplementation (iron & vitamin A), cord care, eye care, Kangaroo Care, delayed bathing, colostrum administration and linkages to immunization services), complications/illness management through stabilization/referral of cases.
~Provision of Information on family planning, birth spacing, LAM counseling, hygiene, danger signs recognition and complications readiness.
~Nutrition counseling regarding immediate and exclusive breastfeeding and optimum postpartum diets.
~5. Danger signs of newborn illnesses and maternal complications associated with labor and the postpartum period, care seeking. Early referral for subsequent maternal and newborn morbidities, such as anemia, postpartum depression, fistulas, prolapsed uterus and infections."
16200729|NCT01389206|Drug|observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi|observational study with patients treated with Tracleer, Ventavis, Veletri, Opsumit and/or Uptravi
16200730|NCT01389193|Drug|Ibudilast|Ibudilast 40 mg twice daily oral capsules for a duration of 8 weeks
16200731|NCT01389193|Drug|Placebo|Placebo 40 mg twice daily oral capsules for a duration of 8 weeks
16200732|NCT01389180|Behavioral|Behavioral Drug and HIV Risk Reduction Counseling|BDRC is a highly individualized, structured, and prescriptive behavioral treatment designed to be provided by nursing or other available personnel in China who generally do not have advanced training or experience in psychotherapy or counseling techniques. BDRC provides education about HIV, Hepatitis C, and other bloodborne or infectious diseases, heroin addiction and MMT, incorporates coping skills training components of CBT, and makes use of explicit and detailed short-term behavioral contracts (either verbal or written), aimed at small, easily achievable, and measurable objectives linked to reduction of HIV risk behaviors and heroin use and improvements in daily functioning supporting sustained recovery
16200733|NCT01389180|Behavioral|Educational Counseling|EC uses a didactic lecture-discussion format, incorporating charts, slides, and audiovisual materials and handouts, to educate the patient about core recovery topics, including HIV and other infectious diseases transmission and effective protection strategies, heroin addiction and treatment with methadone maintenance, the importance of taking the methadone regularly, staying away from drugs, and improving social, family and vocational functioning.
16200734|NCT01389180|Behavioral|Treatment as Usual|TAU group will receive manual-guided minimal counseling approximating the current standard of care provided in MMTs in China, consisting of an initial introductory session (introduction to MMT and basic education about HIV risks) and subsequent, brief (up to 20 minutes) support and advice sessions once per month
16200735|NCT01389167|Drug|Vivitrol|An extended release naltrexone formulation for intramuscular injection
16200736|NCT01389167|Drug|Naltrexone (oral)|Naltrexone 50 mg pills, daily
16200737|NCT01389167|Behavioral|BDRC|Manual-guided BDRC is a highly structured, educational, prescriptive, and individualized treatment that focuses on the patient's current problem areas that are immediately related to marinating abstinence in order to achieve sustained recovery from drugs. The primary goals of BDRC include education about the disease of opiate dependence and effective treatment approaches, skills and strategies to maintain drug abstinence following detoxification, reduction/cessation of drug and sexual behaviors associated with HIV transmission, and increased engagement in non-drug-related social interactions and pleasurable activities.
16200738|NCT01389167|Behavioral|Medical Management|Patient assigned to MM will receive manual-guided medically oriented counseling approximating the current standard of care provided in with NTM the Russian Federation, consisting of an initial introductory session (introduction to NMT and basic education about HIV risks) and subsequent, brief (up to 20 minutes) support and advice sessions once per month.
16200739|NCT01389154|Procedure|Lung biopsy using Always On EM Tip Tracked Device|Patients screened by CT to have a subsegmental, less than 3.0 centimeter lung lesion will be assigned to outpatient bronchoscopy. The patient will have a chest CT with the Always on Patient vPad. Access to the lesion will be achieved using Electromagnetic Tip Tracked devices. Once accessed the operator will use the Electromagnetic Tip Tracked devices or standard devices to obtain a biopsy sample to then be to pathology for diagnosis and reporting. Once completed the patient will be moved to recovery and discharged. If the biopsy is negative the patient will be advised by the pulmonologist about other interventions, watchful waiting, or no further treatment. If the biopsy is positive, the patient will be referred to their physician for further treatment.
16200740|NCT01389128|Other|Non-pharmacological resources|"A sequence of non-pharmacological resources were applied to the patient by the researcher according to uterine cervical dilation, as follows:
~Pelvic mobility on the exercise ball oriented and accompanied by the researcher for 40 minutes;
~Lumbosacral massage for a period of 40 minutes, when dilation was between 5 and 6 cm. During the procedure, the woman in labor was allowed to freely choose the most comfortable position; and,
~Warm shower with the water flow directed to the lower-back of the woman in labor, for 40 minutes, when uterine cervical dilation was equal to or higher than 7cm."
16200945|NCT01387308|Drug|Fostamatinib|Oral tablets, 50 mg x 3, single dose
16200946|NCT01387308|Drug|Fostamatinib|Oral tablets, 100 mg, single dose
16200741|NCT01389128|Other|Routine care|Routine care of the institution performed by the staff, without the presence of the researcher that included offering a balanced meal, continuous support with the presence of a partner or family throughout labor, use of oxytocin when prescribed by the staff, use of drug analgesia when requested by the patient.
16200742|NCT01389102|Drug|Estradiol transdermal one 90 μL spray|Estradiol transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
16200743|NCT01389102|Drug|Estradiol transdermal spray, two 90 μL sprays|Estradiol transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
16200744|NCT01389102|Drug|Estradiol transdermal three 90 μL sprays|Estradiol transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
16200745|NCT01389102|Drug|Placebo transdermal two 90 μL sprays|Placebo transdermal spray, two 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
16200746|NCT01389102|Drug|Placebo transdermal three 90 μL sprays|Placebo transdermal spray, three 90 μL spray applied to adjacent non-overlapping areas on 1 inner forearm daily for 12 weeks using a blinded applicator
16200747|NCT01389102|Drug|Placebo transdermal one 90 μL spray|Placebo transdermal spray, one 90 μL spray applied to 1 inner forearm daily for 12 weeks using a blinded applicator
16200748|NCT01389089|Other|ice gel pack|ice gel pack combined with elevation
16200749|NCT01389089|Other|Multi-layer compression bandage|Application of a multi-layer compression bandage to the foot and lower limb (two layers of wool followed by several layers of a short stretch bandage).
16200750|NCT01389089|Device|A-V Impulse compression|A-V Impulse compression dosage: 130mmHg exerted to the sole of the foot for one second, every twenty second.
16200751|NCT01389076|Drug|Bexxar|"Iodine I 131 tositumomab (Bexxar) is a radioimmunotherapy (RIT) drug. RIT is a treatment strategy designed to target radiation specifically to cancer cells by attaching a radioactive atom to a monoclonal antibody, an immune system protein that binds to a particular protein. The Iodine I 131 tositumomab (Bexxar) therapeutic regimen is delivered in two sets of intravenous infusions given about 7 days apart. Nonradioactive Tositumomab is given before both the dosimetric infusion and the therapeutic infusion to improve distribution of these doses throughout the body."
16200752|NCT01389076|Drug|Low Dose Methotrexate|Methotrexate is an antifolate drug. It interferes with cells' ability to copy their DNA. This mainly affects cells that are dividing frequently, such as immune system cells and cancer cells. Methotrexate will be used in this study to try to prevent the occurrence of HAMA by limiting your body's ability to produce anti mouse antibodies.
16200753|NCT01389063|Drug|Maraviroc|HAART of subjects enrolled in arm A will be intensified with maraviroc during week 1-8.
16200754|NCT01389050|Radiation|Intensity-Modulated Radiotherapy|Radiotherapy for the treatment of retroperitoneal sarcoma. IMRT will be 50.4 Gy given in 28 fractions.
16200755|NCT01389050|Radiation|Daily Cone Beam CT|Images and information from the daily CT will be used for the repositioning of the patient prior to their treatments as per standard procedures.
16200756|NCT01389037|Behavioral|Health Literacy-focused Self-help|Weekly 2-hour sessions over 6 weeks followed by 12 month follow-up with home blood pressure self monitoring with telephone counseling by community health workers.
16200757|NCT01389037|Behavioral|Delayed Intervention Control|Given pamphlets on the importance of high blood pressure control and offered weekly workshops. This group will be offered the intervention at the conclusion of data collection.
16200758|NCT01389024|Drug|Hydroxyurea|Hydroxyurea solution 100 mg/ml with a starting dose of 20 mg/kg/day by mouth once daily and escalation by 5 mg/kg/day every 8 weeks until hematological toxicity, an absolute neutrophil count of 2000 to 4000/ul, or a maximum dose of 35 mg/kg/day.
16200759|NCT01389024|Drug|Placebo|Sucrose solution 0.2 ml/kg/day by mouth once a day with blinded dose escalation of 0.05 ml/kg/day to match the frequency of dose escalation in the hydroxyurea arm.
16200760|NCT01388998|Other|Changes of difference in pulse pressure and plethysmography after applying various pressure levels on the caval vein|Following hepatic resection, a fitting area for pressure application on the caval vein will be identified by the attending surgeon. Baseline assessments of hemodynamic and heart-lung interaction parameters will be taken. Thereafter the surgeon will apply three different pressure levels (2 N, 5 N, 10 N) at random with a force gauge (Fa. ATP Messtechnik, Ettenheim, Germany). Assessment of the parameters will be performed after 2 minutes of pressure application by an investigator, unaware of the pressure applied. After each pressure application 5 minutes will be waited to assure hemodynamic recovery.
16200761|NCT01388985|Biological|Human Diploid Cell Vaccine (HDCV) rabies vaccine|Human Diploid Cell Vaccine (HDCV) rabies Merieux 1 ml vaccine for rabies, provided by Sanofi-Pasteur, administered zvia ID route at two sites
16200762|NCT01388959|Drug|rituximab [MabThera/Rituxan]|375 mg/m2 intravenously once a week for 4 weeks
16200763|NCT01388946|Drug|Ropivacaine 0.75|
16200764|NCT01388946|Drug|Normal saline|
16200765|NCT01388933|Drug|TU-100|15g daily, orally as 5g three times daily for 8 consecutive weeks
16200766|NCT01388933|Drug|Matching Placebo|15g as 5g three times daily, orally for 8 consecutive weeks
16200767|NCT01388920|Drug|Tesamorelin|
16200768|NCT01388907|Other|Ringer lactate solution|Ringer lactate solution was applied directly onto the uterine surgical sites at the end of the myomectomy surgery, to prevent post-surgical adhesion formation.
16200769|NCT01388907|Device|Prevadh film|Prevadh film was applied directly onto the uterine surgical sites at the end of the myomectomy surgery to prevent post-surgical adhesion formation.
16200770|NCT01388881|Other|Music Education|"The intervention - music classes - will be methodologically and educationally based on the National Curriculum Parameters that were developed in Brazilian in the 80s; the focus here is centered on a modern approach to music education where the traditional process of musical learning is not restricted to the domain of the musical reading (sheet music), but also includes musical improvisation, composition and interpretation. Children will be encouraged to create their own music; perception and identification of the elements of musical language in production activities will be explained to them by means of voice, body, sound materials and tools available. Song lyrics, rhymes and rap will be created using elements of musical language not focused purely on the classical elements/music."
16200947|NCT01387308|Drug|Fostamatinib|Oral tablets, 150 mg, single dose
16200771|NCT01388868|Other|TOF count guided adjustment|adjustment of vecuronium infusion dose every 15 minutes as guided by No. of response to TOF stimulation displayed by NMT module.
16200772|NCT01388868|Other|T1/ T0 guided adjustment|adjustment of vecuronium infusion dose every 15 minutes as guided by T1 twitch height as compared with baseline (T0) displayed by NMT module.
16200773|NCT01388868|Other|T2/ T0 guided adjustment|adjustment of vecuronium infusion dose every 15 minutes as guided by T2 twitch height as compared with baseline (T0)displayed by NMT module.
16200774|NCT01388855|Drug|Cholecalciferol|Subjects receive cholecalciferol 20,000 IU daily for 30 days followed by 20,000 IU once weekly for 8 weeks.
16200775|NCT01388855|Drug|Placebo|Pills made to look like vitamin D but have no medication in them
16200776|NCT01388842|Drug|inhaled nitric oxide|Study drug will be administered using an INOpulse delivery system that delivers small pulses of study drug to the patient via a nasal cannula. Subjects randomized to the intervention arm will receive a dose equivalent to 80 ppm iNO in air for 24 hours per day for a minimum of two days and until clinical improvement (coma recovery), death or a maximum of 5 days.
16200777|NCT01388842|Drug|Placebo|The placebo will be administered using an INOpulse delivery system that delivers small pulses of study drug to the patient via a nasal cannula. Subjects randomized to the placebo arm will receive nitrogen in air for 24 hours per day for a minimum of two days and until clinical improvement (coma recovery), death or a maximum of 5 days.
16200778|NCT01388829|Drug|Treatment A|150 mg single dose of PF 04991532 tablets (1x150 mg) manufactured from the R3 lot
16200779|NCT01388829|Drug|Treatment B|150 mg single dose of PF 04991532 tablets (1x150 mg) manufactured from the R4 lot
16200780|NCT01388816|Drug|DRL-17822 or placebo|DRL-17822 50, 150 or 300 mg or matching placebo once daily after breakfast
16200781|NCT01388790|Drug|Cetuximab|Single first dose of cetuximab 400 milligram per square meter (mg/m^2) will be administered intravenously followed by once weekly subsequent intravenous infusion of cetuximab 250 mg/m^2 in each 5-week treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
16200782|NCT01388790|Drug|Cisplatin|Cisplatin 60 mg/m^2 will administered as intravenous infusion on Day 8 of each 5-week cycle maximum up to 8 cycles until disease progression, unacceptable toxicity, or withdrawal of consent
16200783|NCT01388790|Drug|S-1|S-1, a combination of tegafur, gimeracil, and oteracil will be administered intravenously at a dose of 40 to 60 mg/m^2 orally twice daily for first three consecutive weeks of 5-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.
16200784|NCT01388777|Device|Visica 2™ Treatment System|The Visica 2™ Treatment System uses a closed system to circulate liquid nitrogen within the probe tip creating sub-freezing temperatures that result in precision cryoablation of the intended target tissue.
16200785|NCT01388777|Procedure|Cryoablation|Cryoablation procedure uses a hollow, thin tube called a cryoprobe to freeze and destroy cancer tissue. The cryoprobe needle insertion is done using ultrasound guide to reach target, procedure lasts about 20 minutes.
16200786|NCT01388777|Procedure|Surgical Resection|Complete surgical resection of the primary tumor following cryoablation therapy.
16200787|NCT01388764|Drug|L-arginine|Subjects will receive oral L-Arginine (0.3 grams/kg/day, divided 2 times per day, not to exceed 14 grams/day)
16200788|NCT01388751|Procedure|night splinting|splint finger at night for 4 weeks
16200789|NCT01388738|Drug|citicoline|citicoline IV 2000 mg, then citicoline 900 mg/day (300mg*3 times per day) per os
16200790|NCT01388738|Drug|L-Alpha glycerylphosphorylcholine|choline alfoscerate IV 1000mg daily 10 days
16200791|NCT01388738|Drug|cerebrolysin|Cerebrolysin IV 10 ml daily 10 days
16200792|NCT01388712|Dietary Supplement|Lactobacillus reuteri DSM 17938|Patients, who met inclusion criteria, will receive following medicaments during 8 weeks: Lactobacillus reuteri DSM 17938 in form of chewing (one tablets containing 10^8CFU).
16200793|NCT01388712|Dietary Supplement|Placebo|Patients, who met inclusion criteria, will receive an identical to probiotic looking and tasting placebo.
16200794|NCT01388673|Procedure|BaroSense ACE Stapler for plication of dilated post-surgical gastric anatomy|The ACE Stapler is used endoscopically, an incorporates a unique tissue capture mechanism to produce large, permanent serosa to serosa plications in a completely trans-oral approach.
16200795|NCT01388660|Drug|Cloas|A tablet containing 75 mg of Clopidogrel and 100 mg of Aspirin, PO, 2 tablet once daily for Period I & II Day 1 (crossover manner)
16200796|NCT01388660|Drug|Plavix/Astrix|Simultaneous Administration of Plavix (75 mg of Clopidogrel) and Astrix (100 mg of Aspirin), 2 tablets once daily for Period I & II Day 1 (crossover manner)
16200797|NCT01388647|Drug|eribulin|During Phase I, the eribulin dose will be assigned upon study enrollment. The maximum tolerated dose (MTD) determined in Phase I will be the dose used for Phase II. Eribulin will be administered intravenously (IV) over 2 to 5 minutes on Days 1 and 8 of each cycle.
16200798|NCT01388647|Drug|carboplatin|Carboplatin area under the curve (AUC) 6 will be administered IV over 15 to 30 minutes on Day 1 of each cycle.
16200799|NCT01388647|Drug|trastuzumab|Trastuzumab will be administered as an IV infusion on Day 1 of each cycle. A loading dose of 8 mg/kg of trastuzumab will be administered over 90 minutes on Cycle 1 Day 1. Then, a maintenance dose of 6 mg/kg of trastuzumab will be administered over 30 to 90 minutes on Day 1 of Cycles 2 - 6.
16200800|NCT01388621|Drug|Panitumumab|Panitumumab 6 mg/kg/BW d1 + 15 q4w until progressive disease or for a max. of 6 cycles In case of CR, PR or SD at the end of the combination treatment in experimental arm, panitumumab monotherapy is to be continued with 9 mg/kg/BW d1 q3w until time of tumor progression or up to a maximum of 6 months.
16200801|NCT01388621|Drug|pegylated liposomal doxorubicin (PLD)|pegylated liposomal doxorubicin (PLD) 30 mg/m² d1 q4w until progressive disease or for a max. of 6 cycles
16200802|NCT01388621|Drug|Carboplatin|Carboplatin AUC 5 d1 q4w until progressive disease or for a max. of 6 cycles
16200803|NCT01388621|Drug|Gemcitabine|gemcitabine 1000 mg/m² d1 + 8 q3w until progressive disease or for a max. of 6 cycles
16200804|NCT01388621|Drug|Carboplatin|Carboplatin AUC 4 d1 q3w until progressive disease or for a max. of 6 cycles
16200805|NCT01388621|Drug|Panitumumab|Panitumumab 9 mg/kg/BW d1 q3w until progressive disease or for a max. of 6 cycles In case of CR, PR or SD at the end of the combination treatment in experimental arm, panitumumab monotherapy is to be continued with 9 mg/kg/BW d1 q3w until time of tumor progression or up to a maximum of 6 months.
16200948|NCT01387308|Drug|Fostamatinib|Oral tablets, 50 mg x 2, single dose
16200806|NCT01388595|Drug|FLUTICASONE PROPRIONATE|1. Fluticasone Propionate (FP) Product name: Flixotide Evohaler® Manufacturer: Allan and Hanbury's Active ingredients: Fluticasone Propionate Propellant: HFA 134a Dose: 250μg per actuation giving a total dose of 500µg per day through the spacer device with the customised nasal adaptor.
16200807|NCT01388595|Drug|Salmeterol|Salmeterol Product Name: Serevent® Manufacturer: Allan and Hanbury's Active ingredients: Salmetrol Xinafoate Propellant: HFA 134a Dose: 25μg per actuation giving a total dose of 50µg per day through the spacer device with the customised nasal adaptor
16200808|NCT01388595|Drug|PLACEBO|4. Placebo inhaler to SM, FP, SM+FP Manufacturer: Cipla Ltd Active ingredients: None Propellants: HFA 134a Imported & QP release tested in UK : DHP Clinical supplies, Powys, UK
16200809|NCT01388582|Device|LNG-IUS|10 women will receive the LNG-IUS during breastfeeding
16200810|NCT01388582|Device|Implanon|60 mcg/day contraceptive implant
16200811|NCT01388582|Drug|30 mcg EE and 150 LNG oral contraceptive (Microvlar)|10 women will receive oral contraceptive during breastfeeding
16200812|NCT01388582|Device|TCu380A copper-intrauterine device|Tcu380A copper-intrauterine device will be inserted on 10 women during breastfeeding as non-hormonal comparator group
16200813|NCT01388582|Device|TCu380A intrauterine device|10 women will receive a TCu380A intrauterine device as non hormonal contraceptive method during breastfeeding
16200814|NCT01388569|Other|flow cytometry|
16200815|NCT01388569|Other|immunologic technique|
16200816|NCT01388569|Other|laboratory biomarker analysis|
16200817|NCT01388556|Behavioral|Tango dancing|Twice weekly tango dance classes
16200818|NCT01388543|Drug|Atazanavir|Atazanavir 400mg once daily for 7 days followed by atazanavir 300mg plus ritonavir 100mg for 7 days
16200819|NCT01388530|Device|EMS 7500 Digital Muscle Stimulator|A standard FDA approved transcutaneous electrical nerve stimulation (TENS) unit will be used to apply low intensity stimulation to the trigeminal nerves during sleep.
16200820|NCT01388517|Drug|Tacrolimus|0.1% tacrolimus ointment to apply twice a day for 9 weeks on pytiriasis alba plaques.
16200821|NCT01388517|Drug|Calcitriol|0.0003% calcitriol ointment to apply twice a day for 9 weeks on pytiriasis alba plaques.
16200822|NCT01388517|Drug|Petrolatum|Petrolatum ointment to apply twice a day for 9 weeks on pytiriasis alba plaques.
16200823|NCT01388504|Drug|sodium nitrite|sterile solution containing low dose sodium nitrite dissolved in 5ml water injected intravenously over a period of 2½ - 5 minutes immediately prior to opening of the infarct related artery using Percutaneous Coronary Intervention
16200824|NCT01388504|Other|Placebo|sterile solution containing 0.9%w/v sodium chloride in 5ml water injected intravenously over a period of 2½ - 5 minutes immediately prior to Percutaneous Coronary Intervention
16200825|NCT01388491|Drug|desogestrel/ethinyl estradiol and ethinyl estradiol|
16200826|NCT01388491|Drug|desogestrel/ethinyl estradiol|
16200827|NCT01388478|Drug|R-pramipexole|R-pramipexole will be taken as a liquid and start at one teaspoon (5 ml) twice a day for a total dose of 100 mg/day. After 4 weeks, the dose will double (two teaspoons twice a day, or a total of 200mg/day). Four weeks later the dose will be increased again to 2 1/2 teaspoons twice a day (total of 300mg/day) where it will remain for the remaining 16 weeks of study treatment. Prior to each increase, participants and their study partners will be interviewed regarding any possible side effects or problems. These findings will be discussed with the physician prior to increasing the study drug dose. The dose will only increase if the participant is not having side effects.
16200828|NCT01388465|Behavioral|Mobile phone text messaging|Daily assessment followed by feedback
16200829|NCT01388452|Device|Point of care HIV RNA PCR|The intervention is a HIV RNA PCR test for which UNC Project laboratory personnel will process samples in 48 hours so that patients can receive results prior to hospital discharge.
16200830|NCT01388439|Drug|Oseltamivir|Treatment dose was oseltamivir 3 mg/kg/dose by mouth (PO) twice daily. Prophylactic dose was oseltamivir 1 mg/kg/dose PO once daily to infants < 28 weeks postmenstrual age (PMA), 1 mg/kg/dose PO twice daily to infants 28 - 38 weeks PMA, and 3 mg/kg/dose PO once daily to infants > 38 weeks PMA. Dosing in infants < 28 weeks PMA was chosen based on unpublished data from Acosta et al. This data was obtained from phone contact with Dr. Peter Gal, co-author of the study. Dosing in infants 28 - 38 weeks PMA was chosen based on published data from Acosta et al.1 Dosing in infants > 38 weeks PMA and less than 3 months postnatal age was chosen based on data from Kimberlin et al. Dosing in infants > 38 weeks PMA and greater than 3 months postnatal age was per the recommendations of the Advisory Committee on Immunization Practices of the United States Department of Health and Human Services.
16200831|NCT01388426|Device|7eye( Panoptx)™ moisture chamber glasses|moisture chamber glasses
16200832|NCT01388413|Drug|Weekly Oral Cyclic Antibiotic programme|The Weekly Oral Cyclic Antibiotic Programme consisted of the alternate administration of an antibiotic once per week. The antibiotics that were chosen (efficient for urinary tract infection, well tolerated, low selection pressure) included : Amoxicillin 6000 mg, Amoxicillin/clavulanic acid 3000 mg, Cefixime 400 mg, Fosfomycin trometamol 6000 mg, Trimethoprim/sulfamethoxazole 2400 mg. During week A,the patient received a single antibiotic (A), and the following week B the patient was given another antibiotic (B). For each patient, antibiotics were specifically chosen according to the results of urine cultures.
16200833|NCT01388400|Other|conventional occupational therapy|upper limb exercises
16200834|NCT01388400|Device|video capture virtual reality|virtual reality delivered uppe limb exercises
16200835|NCT01388387|Other|Tacrolimus pharmacokinetics|tacrolimus pharmacokinetics over 12 hours
16200836|NCT01388374|Other|Other, care provided by Nurse Practitioners|Patients will receive care at the Primary Out of Hours Emergency Service by a Nurse Practitioner instead of a General Practitioner (substitution of care from physicians to nurses).
16200837|NCT01388361|Drug|insulin degludec|Injected s.c. (under the skin) once daily. The doses will be individually adjusted
16200838|NCT01388361|Drug|insulin aspart|Injected s.c. (under the skin) once daily. The doses will be individually adjusted.
16200839|NCT01388361|Drug|liraglutide|Injected s.c. (under the skin) once daily. The doses will be individually adjusted.
16200840|NCT01388348|Device|"Dynamic Urine Vibration Holter"|"each subject will undergo intervention for the diagnosis of bladder outlet obstruction first using the Dynamic Urine Vibration Holter and then urodynamically by pressure flow study"
16200841|NCT01388335|Drug|warfarin|Administered orally
16200842|NCT01388335|Drug|enzastaurin|Administered orally
16200843|NCT01388322|Drug|Enoxaparin|40 mg (4000 IU) women <80 kg at the time of randomization or 60 mg (6000 IU) women> 80 kg at the time of randomization One dose daily. Subcutaneous administration. Treatment periods: the same day of the Initiation visit (from 9 to 13.6 weeks of gestation) until 36 weeks gestation.
16200844|NCT01388270|Device|a pre-heparin-coated hemodialysis filter; Hepran|Use of the pre-heparin-coated filter compared to the conventional filter in a cross over design
16200845|NCT01388257|Procedure|All types of surgery procedures|All types of surgery procedures used for anoperineal fistula repair. Surgery procedures include fistulotomy, biological glue, rectal advancement flap and plug.
16200846|NCT01388257|Procedure|Simple seton drain removal|Patients are simply followed after seton drain removal.
16200847|NCT01388244|Other|Screening|Screening by risk factor assessment (FRAX) followed by DXA
16200848|NCT01388244|Other|Control|Observation by use of register data
16200849|NCT01388231|Behavioral|CBT-Manualized Intervention|Cognitive-behavioral therapy (CBT) for social phobia following the Clark and Wells (1995) model of social phobia.
16200850|NCT01388231|Behavioral|CBT-Treatment as Usual|Cognitive-behavioral therapy for social phobia following no specific model.
16200851|NCT01388205|Behavioral|Family-based Outdoor program|2 to 3 hour outdoor activities organized in conjunction with National Parks, Singapore
16200852|NCT01388179|Device|Transcranial Magnetic Stimulation|low-frequency rTMS to the left DLPFC prior to high-frequency deep rTMS to the FFA through the STS.
16200853|NCT01388166|Procedure|Education|Education
16200854|NCT01388153|Drug|Acarbose (Glucobay ODT, BAYG5421)|Day 1: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay ODT; Day 2: oral sucrose load plus Glucobay ODT taken without water
16200855|NCT01388153|Drug|Acarbose (Glucobay ODT, BAYG5421)|Day 1: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay ODT; Day 2: oral sucrose load plus Glucobay ODT taken with water
16200856|NCT01388153|Drug|Acarbose (Glucobay, BAYG5421)|Day 1: oral sucrose load (75 g sucrose dissolved in 225 mL water) without Glucobay standard tablet; Day 2: oral sucrose load plus Glucobay standard tablet taken with water
16200857|NCT01388114|Device|Electrosensing Antibody Probe System (e- Ab sensing)|Electrosensing antibody probing system (e- Ab sensing), which was developed for the rapid and sensitive detection of hapten, proteins or viral antigen in medical samples, will be used for analyzing the interaction kinetics between anti-procalcitonin antibody and procalcitonin in the serum of the patients. The system incorporates the use of engineered semiconductive antibodies or virus in vertical and lateral chip (eAbchip) or lateral flow through (eAbsignal) formats. In electrosensing antibody probing, semiconductive antibodies are bound as a suitable electrosensing probe which specifically and selectively binds procalcitonin polypeptide target molecules in the test specimen
16200858|NCT01388101|Device|Electrosensing antibody probing system (e- Ab sensor)|Electrosensing antibody probing system (e- Ab sensor), which was developed for the rapid and sensitive detection of hapten, proteins, or viral antigen in medical samples, will be used for analyzing the interaction kinetics between specific anti- LECT2 and its antigen (LECT2 with liver cancer) present in the specimens of patients with liver cancer. The system incorporates the use of engineered semiconductive antibodies or virus in vertical and lateral chip (eAbchip) or lateral flow through (eAbsignal) formats. In electrosensing antibody probing, semiconductive antibodies are bound as a suitable electrosensing probe, which specifically and selectively binds targeted molecules (i.e. specific LECT2) in the test specimens.
16200859|NCT01388088|Drug|Spironolactone|25 mg twice a day
16200860|NCT01388088|Drug|Amiloride|5 mg twice a day
16200861|NCT01388088|Drug|Placebo|twice a day
16200862|NCT01388075|Drug|Rifampicin|oral, 450 mg/day , 7 days
16200863|NCT01388062|Device|Electrosensing antibody probing system (e- Ab sensor)|Electrosensing antibody probing system (e- Ab sensor), which was developed for the rapid and sensitive detection of hapten, proteins, or viral antigen in medical samples, will be used for analyzing the interaction kinetics between anti- influenza virus antibody and its antigen (influenza virus) present in patients. The system incorporates the use of engineered semiconductive antibodies or virus in vertical and lateral chip (eAbchip) or lateral flow through (eAbsignal) formats. In electrosensing antibody probing, semiconductive antibodies are bound as a suitable electrosensing probe, which specifically and selectively binds targeted molecules (influenza virus) in the test specimens. From assessment of the electric signature of semiconductive anti- influenza virus antibodies, the eABprobe could offer sensitive detection and precise quantification of EV71.
16200864|NCT01388049|Device|Electrosensing antibody probing system (e- Ab sensor)|Electrosensing antibody probing system (e- Ab sensor), which was developed for the rapid and sensitive detection of hapten, proteins, or viral antigen in medical samples, will be used for analyzing the interaction kinetics between anti-EV71 antibody and its antigen (EV71) present in patients. The system incorporates the use of engineered semiconducive antibodies or virus in vertical and lateral chip (eAbchip) or lateral flow through (eAbsignal) formats. In electrosensing antibody probing, semiconductive antibodies are bound as a suitable electrosensing probe, which specifically and selectively binds targeted molecules (EV71) in the test specimens. From assessment of the electric signature of semiconductive anti-EV71 antibodies, the eABprobe could offer sensitive detection and precise quantification of EV71.
16200865|NCT01388036|Drug|esmolol|consecutive infusions of esmolol and normal saline (placebo)
16200866|NCT01388023|Dietary Supplement|herbal formula for fresh breath|composition of herbal ingridients in a palatal mucoadhesive patch to remove volatile solfur compounds and reducequantity of vsc creating bacteria
16200867|NCT01388010|Other|1-Fermented Probiotic Dairy Product (test)|
16200868|NCT01388010|Other|2-Milk-based non-fermented dairy product(control)|
16200869|NCT01387997|Device|Electrosensing antibody probing system (e- Ab sensor)|Electrosensing antibody probing system (e- Ab sensor), which was developed for the rapid and sensitive detection of hapten, proteins, or viral antigen in medical samples, will be used for analyzing the interaction kinetics between anti-high risk HPV and its antigen (high-risk HPV) present in patients. The system incorporates the use of engineered semiconducive antibodies or virus in vertical and lateral chip (eAbchip) or lateral flow through (eAbsignal) formats. In electrosensing antibody probing, semiconductive antibodies are bound as a suitable electrosensing probe, which specifically and selectively binds targeted molecules (high-risk HPV) in the test specimens. From assessment of the electric signature of semiconductive anti- high-risk HPV antibodies, the eABprobe could offer sensitive detection and precise quantification of high-risk HPV.
16200872|NCT01387945|Behavioral|HBPM+website+patient navigator|In addition to home blood pressure monitor, patient receives access to BP web portal and trained patient navigator.
16200873|NCT01387932|Device|HepaSphere/QuadraSphere Microspheres|HepaSphere/QuadraSphere Microspheres loaded with doxorubicin
16200874|NCT01387932|Procedure|PVA, lipiodol, doxorubicin|Conventional TACE procedure using PVA, lipiodol and doxorubicin
16200875|NCT01387919|Behavioral|Prolonged fasting|48 hours of fasting
16200876|NCT01387906|Drug|topical bimatoprost|topical bimatoprost will be applied one drop to each eyebrow each night.
16200877|NCT01387893|Behavioral|the Digital Repetitive Infrapubic Pressure maneuver|The Digital Repetitive Infrapubic Pressure maneuver is performed by exerting moderate inwards pressure with the index and middle fingers, spread slightly apart, palm-side up, pushing into the fold of skin at the base of the penis, where it comes forward beneath the pubic bones, one fingertip on each side of the penis' suspensory ligament. By repeatedly pushing inwards and slightly upwards, at a rate of about once per second, to a distance of about two centimeters, at times of significant urinary hesitancy it is often possible either to initiate spontaneous flow, or to pass a small quantity of urine with each push, such that after a minute or two one can empty the bladder to a satisfactory degree. While a few men find it useful when voiding in a standing position, for the majority, the maneuver requires a forward-leaning seated posture for optimal results.
16200878|NCT01387880|Drug|Everolimus|"Patients with KRAS mutant tumours are treated with cetuximab, everolimus and irinotecan as third line.
~Patients with KRAS wildtype tumours that have progressed on therapy with cetuximab and irinotecan are treated with cetuximab, everolimus and Irinotecan."
16200879|NCT01387880|Drug|Everolimus|1.66 mg per day up to 7½ mg per day
16200880|NCT01387867|Procedure|Strength training|Supervised strength training in groups 2 x 1 hour weekly and un-supervised strength training 1 hour weekly for 4 months
16200881|NCT01387867|Procedure|Nordic Walking|Supervised Nordic Walking in groups 2 x 1 hour weekly and un-supervised Nordic Walking 1 hour weekly for 4 months
16200882|NCT01387867|Procedure|Unsupervised home based exercise|Unsupervised home based exercise as recommended by the Danish Arthritis Association 1 hour 3 x weekly for 4 months
16200883|NCT01387841|Behavioral|yoga|Postures,relaxation techniques
16200884|NCT01387841|Behavioral|Jacobsons PMRT group|jacobsons Progressive muscle relaxation training involving 16 muscle groups
16200885|NCT01387828|Procedure|Laparoscopic splenic aneurysm repair, eventual splenectomy|Aneurysmectomy and eventual artery reconstruction or splenectomy performed with a laparoscopic approach
16200886|NCT01387828|Procedure|Laparotomic splenic artery aneurysm repair, eventual artery reconstruction or splenectomy|Aneurysmectomy and eventual artery reconstruction or splenectomy performed with a laparotomic approach
16200887|NCT01387815|Biological|Adalimumab|Adalimumab administered by subcutaneous injection.
16200888|NCT01387763|Drug|PegIntron|PegIntron, prefilled syringe 50 micrograms/0.5 ml. 30 micrograms subcutaneously once weekly.
16200889|NCT01387763|Drug|Pegasys|Pegasys, prefilled syringe 180 micrograms/0.5 ml 45 micrograms subcutaneously once weekly
16200890|NCT01387763|Drug|PegIntron|PegIntron, prefilled syringe 50 micrograms/0.5 ml. 30 micrograms subcutaneously once weekly.
16200891|NCT01387763|Drug|Pegasys|Pegasys, prefilled syringe 180 micrograms/0.5 ml 45 micrograms subcutaneously once weekly
16200892|NCT01387763|Drug|Hydrea|Capsule Hydrea 500-2000 mg orally QD or BID
16200893|NCT01387750|Other|Mentholated Cream|A topical cream containing menthol without the addition of the oxygenated glycerol triesters.
16200894|NCT01387750|Other|Mentholated Cream with OGT|A Topical Cream that contained both menthol and oxygenated glycerol triesters.
16200895|NCT01387737|Drug|TA-7284-Low|TA-7284-Low
16200896|NCT01387737|Drug|TA-7284-High|TA-7284-High
16200897|NCT01387724|Genetic|RNA analysis|
16200898|NCT01387724|Genetic|polymerase chain reaction|
16200899|NCT01387724|Genetic|protein expression analysis|
16200900|NCT01387724|Genetic|proteomic profiling|
16200901|NCT01387724|Genetic|western blotting|
16200902|NCT01387724|Other|enzyme-linked immunosorbent assay|
16200903|NCT01387724|Other|immunohistochemistry staining method|
16200904|NCT01387724|Other|laboratory biomarker analysis|
16200905|NCT01387724|Other|liquid chromatography|
16200906|NCT01387724|Other|mass spectrometry|
16200907|NCT01387711|Drug|PEP005 (Ingenol mebutat Gel, 0.05 %)|All eligible patients will receive PEP005 Gel, 0.05 %, on two consecutive days to both the AK Treatment Area and the Normal Skin Treatment Area
16200908|NCT01387672|Drug|Nitrates (NABT Main trial)|nitroglycerin; isosorbide mononitrate
16200909|NCT01387672|Other|Placebo|Placebo ointment
16200910|NCT01387659|Procedure|Gastric emptying test|Gastric emptying tests will be performed at baseline, 6 months and 12 months
16200911|NCT01387646|Behavioral|Project IMAGE|Participants in the intervention arm will be interviewed at baseline, given a targeted physical exam including a STI/HIV screen, pap smear and contraception counseling and enrolled in the intervention. The intervention will include 2 workshops, 5 support groups sessions and 2 individual counseling sessions. They will be interviewed and examined again after completing the intervention, to establish a post-intervention baseline.
16200912|NCT01387633|Other|Educational intervention for family members/caregivers of people with diabetes mellitus through telephone contact|For family members/caregivers: telephone contacts will be conducted in day and time which family member/caregiver prefers, and he/she may make collect calls to the researcher always he/she judges it necessary during the period of study. Phone contacts will be recorded to ensure the registration of orientation given, using a digital phone recorder PCTEL. And they will be arranged with the technique of motivational interviewing that includes the skills to ask, listen and inform. For this, protocols based on these skills, which the covered topics will be those worked in group sessions through Diabetes Conversation Maps. Voice quality related to the tone, volume and clarity as well as the skills and strategies to listen to the interviews will be worked under the guidance of an audiologist
16200949|NCT01387295|Drug|oxaliplatin, capecitabine, trastuzumab|Oxaliplatin intrahepatic capecitabine and trastuzumab systemic
16200950|NCT01387282|Drug|Anamorelin HCl|Anamorelin HCL 100 mg will be orally administered daily at least 1 hour prior to meal
16200951|NCT01387282|Drug|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour prior to meal before the first meal of the day.
16200913|NCT01387633|Other|Educational intervention group for people with diabetes through Diabetes Conversation Maps|For people with diabetes mellitus: educational interventions will be conducted in accordance with the assumptions of the Social Cognitive Theory, through Diabetes Conversation Maps , whose use is consistent with this theory (ADA, 2007). Diabetes Conversation Maps are a tool which involves people in the learning process about the disease, to make them able to process information more effectively and use them in making daily decisions in the management of diabetes mellitus (DM). It is recommended that this tool is used in small groups of three to ten people, in order to provide dynamic discussions among the participants (ADA, 2007). Currently, the maps that cover the following learning contexts: How the Body and Diabetes Work, Healthy Eating and Physical Activity, and Medication Treatment and Monitoring of Blood Glucose; Achieving the Goals with the Insulin and Weather Map of Diabetic Foot are available for the Brazilian Portuguese language.
16200914|NCT01387620|Drug|Hyaluronic Acid and hydroxypropylmethylcellulose|Hyaluronic Acid 1.6% was used to performed phacoemulsification in one eye and hydroxypropylmethylcellulose 2% was used in the fellow eye.
16200915|NCT01387607|Drug|pregabalin|Pregabalin capsule, 300-450mg/day, twice daily
16200916|NCT01387607|Drug|placebo|Placebo, twice daily
16200917|NCT01387594|Procedure|lumbar puncture|2 lumbar punctures prior to treatment; study drug 225mg SC once a month X 3 doses.
16200918|NCT01387594|Drug|lumbar puncture|1 lumbar puncture before and after 3 doses; study drug 225mg SC once a month X 3 doses.
16200919|NCT01387568|Drug|Lidocaine Infusion|children in group L received i.v. lidocaine 1.5 mg/kg followed by infusion at 1.5 mg. kg-1.h-1. and were continued up to 6 hours postoperatively
16200920|NCT01387568|Drug|saline Infusion|children in group P received i.v. saline 0.9% 1 ml/kg followed by infusion at 0.1 ml. kg-1.h-1,and were continued up to 6 hours postoperatively
16200921|NCT01387555|Biological|JX-594 recombinant vaccina GM-CSF|Patients will be randomised 2:1 to Arm A or Arm B and will receive 6 treatments on days 1, 8, 22, week 6, week 12, and week 18 plus best supportive care as needed.
16200922|NCT01387555|Other|Best Supportive Care|Patients will be randomised 2:1 to Arm A or Arm B and will receive best supportive care as needed.
16200923|NCT01387542|Drug|Paliperidone extended release (ER)|Paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral tablets depending on investigator's discretion once daily for 10 weeks
16200924|NCT01387516|Behavioral|Motivational Intervention|The MI session will be 60-90 minutes in length.The focus is on establishing rapport and building motivation. The counselor explores teen's reasons for entering treatment, prior treatment experience, previous attempts to change use, possible goals for treatment, substance effect expectancies, and perceptions of self-efficacy.A personalized feedback report outlines assessment results, highlights any problems or concerns related to cigarette use expressed by teen, and compares tobacco use levels with national norms for same age and gender peers.
16200925|NCT01387516|Behavioral|Relaxation Therapy|The Relaxation Therapy intervention encompasses several techniques, including Progressive Muscle Relaxation and Visualization-Imagination, and meditation to reduce stress; which may lead to substance use.
16200926|NCT01387516|Behavioral|Cognitive Behavioral Therapy|The Cognitive-Behavioral Therapy (CBT) Intervention focuses on the interrelationship between thoughts, feelings, and behaviors. It addresses specific deficits, such as improving problem solving skills and developing social supports, and behaviors such as substance abuse and smoking.
16200927|NCT01387516|Behavioral|Self-Help Programming|"The Self-Help Programming intervention combines elements of Nicotine anonymous (NicA) to provide someone who uses nicotine but wants a nicotine-free life, with a community of people that has also experienced nicotine addiction and strives to be nicotine free. It incorporate the 12 Steps and the NicA tools (i.e., meetings, phone list, literature, sponsorship, and service) to facilitate and maintain abstinence from nicotine."
16200928|NCT01387503|Procedure|Liver transplantation|Once randomized to Group 1, patients will be enlisted for liver transplantation at the recruiting Center. Prioritization is encouraged as a waiting time of more than 8 months could cause patients' drop-out from the study
16200929|NCT01387490|Behavioral|Individualized Scheduled Telephone Support (ISTS)|ISTS is a telephone intervention that provides injury-related education, training in problem solving, and focused behavioral strategies for problems (e.g., anxiety, depression) that commonly co-occur with Mild Traumatic Brain Injury (MTBI). ISTS also includes access to usual care and web-based and printed educational material. The 12 phone calls included in ISTS will be administered over a 6-month period.
16200930|NCT01387490|Other|Usual Care (UC)|UC is the usual care provided to service members attending the Traumatic Brain Injury (TBI) Clinics at Madigan Army Medical Center and Womack Army Medical Center, plus web-based education and 12 mailings of educational materials over a 6-month period.
16200931|NCT01387477|Drug|Lactate|Infusion of 66 mmol of lactate
16200932|NCT01387477|Drug|Glucose|Infusion of 33 mmol of glucose
16200933|NCT01387464|Drug|ISV-303|0.075% bromfenac in DuraSite dosed QD
16200934|NCT01387464|Drug|Bromday™|0.09% bromfenac dosed QD
16200935|NCT01387425|Drug|varenicline|varenicline at a dose of 1 mg twice a day for 12 week
16200936|NCT01387425|Drug|placebo tablet is made of lactose|placebo at a dose of 1 mg twice for 12 week
16200937|NCT01387399|Procedure|Cisplatin administered intraoperatively as hyperthermic intraperitoneal chemoperfusion|"Classical 3+3 dose escalation study of cisplatin administered as HIPEC (60mg/m², 80mg/m² and 100mg/m²)"
16200938|NCT01387373|Drug|oxaliplatin, capecitabine, trastuzumab|Oxaliplatin intrahepatic capecitabine + trastuzumab systemic
16200939|NCT01387360|Device|Supracor|"The presbyopic treatment consists of a standard treatment for distance vision and the procedure known as SUPRACOR addition to correct near vision.
~The SUPRACOR addition provides a multifocal ablation with a central near addition with an aberration controlled transition zone towards the periphery, thereby allowing good focus over a range of object distances."
16200940|NCT01387347|Drug|Thymosin beta 4|A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.
16200941|NCT01387347|Drug|Placebo|A preservative-free, sterile eye drop solution containing 0.0% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.
16200942|NCT01387334|Behavioral|Resistance Exercise Training Program With Rubber Bands|Resistive exercise consist of 5-min warm up, at least 30 min resistive exercise using rubber band as recommendation (8-12 times per set, at least 3 sets per day and at least 3 days per week) and 5-min cool down
16200952|NCT01387269|Drug|Anamorelin HCl|Anamorelin HCl will be orally administered daily at least one hour before meal
16200953|NCT01387269|Drug|Placebo|Placebo tablets identical in appearance to active tablets; oral administration QD for 12 weeks, at least 1 hour before meal
16200954|NCT01387256|Drug|medical abortion|pregnancy termination with drugs
16200955|NCT01387243|Drug|Orlistat|60 mg
16200956|NCT01387230|Drug|GSK573719|62.5 mcg
16200957|NCT01387230|Drug|GSK573719|125mcg
16200958|NCT01387230|Other|Placebo|Placebo
16200959|NCT01387217|Drug|GSK2018682|GSK2018682
16200960|NCT01387217|Drug|Placebo|Matched Placebo
16200961|NCT01387204|Drug|GSK1120212|The 2 mg dose is based on clinical data from the ongoing FTIH study in which subjects have been dosed daily for greater than 21 days, as well as preclinical toxicity data.
16200962|NCT01387191|Drug|Epoprostenol|
16200963|NCT01387178|Drug|fluticasone propionate/salmeterol 250µg/50µg (FSC)|Patient records with evidence of COPD and prescription claims for FSC
16200964|NCT01387178|Drug|tiotropium bromide (TIO)|Patient records with evidence of COPD and prescription claims for TIO
16200965|NCT01387165|Drug|Treatment|were receiving an oral hypoglycemic agent (OHA) or insulin
16200966|NCT01387139|Drug|Ketamine|1.0 milligrams/kilogram (mg/kg) ketamine with additional doses of 0.5 mg/kg ketamine as needed (maximum single dose based on 100 kilogram (kg) person)
16200967|NCT01387139|Drug|Ketamine Co-administered with Propofol|0.5 mg/kg ketamine and 0.5 mg/kg propofol with additional doses of 0.25 mg/kg ketamine and 0.25 mg/kg propofol as needed (maximum single dose based on 100 kg person)
16200968|NCT01387126|Dietary Supplement|Novel fibre supplement|The full dose of the study intervention is 15 grams per day.
16200969|NCT01387113|Other|Computed tomography perfusion imaging|As per standard of care at CPMC
16200970|NCT01387100|Behavioral|Vocational Rehabilitation Intervention|Physical or occupational therapist will deliver a vocational rehabilitation intervention using the Work Experience Survey for Persons with Rheumatic Conditions (WES-RC) assessment tool to assess subject's health and vocational background as well as work barriers.
16200971|NCT01387087|Drug|ASP015K|oral
16200972|NCT01387087|Drug|Placebo|oral
16200973|NCT01387074|Biological|botulinum toxin Type A|Botulinum toxin Type A treatment at a dose determined by the physician at Baseline followed by a second botulinum toxin Type A treatment approximately 12 weeks later if applicable.
16200974|NCT01387061|Procedure|hepatic resection|surgical resection of the liver for multiple HCC
16200975|NCT01387048|Drug|skinoren|gel 15%, twice daily, 36 weeks
16200976|NCT01387048|Drug|differin|0.1% gel, once daily in the evening
16200977|NCT01387048|Drug|skinoren|12 weeks treatment, the following 24 months only observation
16200978|NCT01387022|Drug|Tenofovir, lamivudine and efavirenz|Tenofovir, 300mg daily, lifelong Lamivudine, 300mg daily, lifelong Efavirenz, 600mg daily, lifelong
16200979|NCT01386996|Drug|Budesonide/formoterol Easyhaler 320/9 microg|2 inhalations as a single dose
16200980|NCT01386996|Drug|Symbicort Turbuhaler forte|2 inhalations as a single dose
16200981|NCT01386983|Drug|5ARI|Dutasteride or Finasteride
16200982|NCT01386983|Drug|5ARI + AB|5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin
16200983|NCT01386970|Drug|zidovudine 300mg and lamivudine 150mg as Combivir|twice daily for 12 days in the HIV-negative group and indefinitely for their care in the HIV-positive group
16200984|NCT01386931|Procedure|EUS-guided FNA performed with on-site Cytopathologist|Patients assigned to the on-site cytopathologist arm will have the cytopathologist dictate the number of FNA passes performed by the endosonographer. This number will be based on the adequacy of specimen and the ability to provide a preliminary diagnosis.
16200985|NCT01386931|Procedure|EUS-guided FNA performed without on-site Cytopathologist|In the absence of an on-site cytopathologist, the endosonographer will perform a predetermined number of 7 passes (standard of care in the absence of an on-site cytopathologist).
16200986|NCT01386918|Device|repetitive Transcranial Magnetic Stimulation|The treatment involves the administration of a magnetic field applied to a specific area of the brain.
16200987|NCT01386905|Device|BAROnova™ TransPyloric Shuttle™ (TPS™)|Subjects will undergo an endoscopic procedure to deliver the TPS™ into the stomach. The TPS™ moves freely without any physical attachment or invasive anchoring to tissue to reduce gastric outflow.
16200988|NCT01386892|Other|No intervention|There is no intervention for this study
16200989|NCT01386879|Drug|methylene blue|A dilute solution of methylene blue (5 ml of 1 % methylene blue solution in saline, 1:1 dilution) will be gently delivered into the hypopharynx using a flexible suction catheter approximately once per hour until trachea is extubated.
16200990|NCT01386866|Drug|AMG 706|Single oral dose of 125 mg AMG 706 (motesanib) containing 100 μCi of [14C]-AMG 706 followed by option to continue onto a treatment extension phase for potential treatment benefit. Subjects will be administered motesanib 125 mg (5 x 25 mg tablets) on a daily basis until subjects experience a dose-limiting toxicity (DLT), an unacceptable AE, disease progression, or voluntary withdrawal.
16200991|NCT01386853|Drug|Pitavastatin|2 mg QD
16200992|NCT01386853|Drug|Atorvastatin|10 mg QD
16200993|NCT01386840|Other|Severe Pneumonia - Home Management|"For those randomized to home management, first dose will be administered by the mother/caretaker under supervision at health facility. The health personnel will assess the parameters like temperature, Respiratory rate, Lower chest indrawing, Pulse rate, clinical deterioration, Other signs eg. co-morbid conditions, Assessment of adherence, Adverse event when they visit the home after 24 hours, 72 hours and on day 8th.
~Mothers will be advised to return to the healthcare facility at their scheduled times and any time during the study period if there is clinical deterioration. The symptoms and signs of clinical deterioration will be discussed with the mother as described in the patient discharge counselling checklist. Mothers will be given a study patient data card with contact Numbers."
16200994|NCT01386827|Biological|Mouse brain derived japanese encephalitis vaccine (MB-JEV)|a) 2-3 doses of MB-JEV vaccine 0.5ml given on day 0, 7, 30 immunization and one booster dose of Ixiaro 0.5 ml > 2 years later
16200995|NCT01386827|Biological|Primary and booster immunizations with MB-JEV|2-3 doses of MB-JEV vaccine 0.5ml given on day 0, 7, 30 as primary immunization and one booster dose of 0.5 ml > 2 years later
16200996|NCT01386827|Biological|C) primary immunizations with Ixiaro|2 0.5 ml doses of Ixiaro 28 days apart
16200997|NCT01386827|Biological|S) Ixiaro booster to MBJEV primed|0.5ml Ixiaro to volunteers previously primed with 2-3 doses of MB-JEV
16200998|NCT01386788|Other|There is no intervention planned (observational)|No intervention foreseen
16200999|NCT01386762|Other|Exercise training|6 months of intense multi-modal exercise consisting of vibration exercise, gait training, electrical stimulation, etc.
16201000|NCT01386749|Procedure|vibration platform provide low magnitude and high frequency vibration treatment, which is self-developed by our research team|Stand on a vibration platform at 35Hz, 0.3g, 20mins/day and 5days/week
16201001|NCT01386736|Drug|Vitamin D drops|Subjects will be randomly assigned to Vitamin D 3,000 Units per day or Placebo drops.
16201002|NCT01386736|Drug|Placebo drops|Subjects will be randomly assigned to Vitamin D 3,000 Units per day or Placebo drops.
16201003|NCT01386723|Drug|Discontinuation of eltrombopag|Observation of subjects as they discontinue the use of eltrombopag
16201006|NCT01386671|Drug|Metformin glycinate|Drug: Metformin glycinate 12 months: 1 month,one tablet 1050.6 mg once daily + 11 months, one tablet 1050.6 mg twice daily
16201007|NCT01386671|Drug|Metformin hydrochloride|12 months: 1 month, once daily dose of 850 mg (before dinner) and 11 months, twice daily dose 850 mg (before breakfast) + 850 mg (before dinner).
16201008|NCT01386658|Drug|icatibant|Single dose of icatibant 0.4 mg/kg subcutaneous(SC) up to a maximal dose of 30 mg
16201009|NCT01386645|Other|low glycemic index (LGI) diet|Following a 2 week medium glycemic index control diet (glycemic index 50-55), subjects will be provided with a weight stable low glycemic index diet (glycemic index <35) for 4 weeks with all food provided by the Human Nutrition Lab
16201010|NCT01386645|Other|high glycemic index (HGI) diet plus placebo (PLAC)|Following a 2 week medium glycemic index control diet (glycemic index 50-55), subjects will be provided with a weight stable high glycemic index diet (glycemic index >70) for 4 weeks, all food provided by the Human Nutrition Lab. They will take placebo capsules (matching for active N-acetylcysteine (NAC) in arm 3) twice daily for the 4 weeks on the high GI diet. The NAC vs. placebo arms (arms 2 and 3) will be double-blinded.
16201011|NCT01386645|Drug|high glycemic index diet plus N-acetylcysteine|Following a 2 week medium glycemic index control diet (glycemic index 50-55), subjects will be provided with a weight stable high glycemic index diet (glycemic index >70) for 4 weeks, all food provided by the Human Nutrition Lab. They will take N-acetylcysteine (NAC) two 600 mg capsules twice daily for the 4 weeks on the high GI diet. The NAC vs. placebo arms (arms 2 and 3) will be double-blinded.
16201012|NCT01386632|Drug|DCA (dichloroacetate)|DCA orally 12.5mg/kg PO or per G-tube BID daily for 8 weeks in conjunction with Cisplatin 100 mg/m^2 IV over 30-60minutes every 3wks X 3(Days 1, 22, and 43 of RT)and RT 70 Gy/35 -200 cGy/d x 7 weeks (35 Fractions)
16201013|NCT01386632|Drug|Placebo|Placebo PO or per G-tube twice a day for 8 weeks given in combination with Cisplatin.
16201014|NCT01386619|Biological|CD3-depleted/CD56+ selected natural killer cells collected from apheresis products|NK DLI products containing >1 10e7 NK cells/kg bodyweight (BW) and < 1 x 10e5 T-cells/kg BW are administered at days +4 (Frankfurt only), and on days +40 and +100 (both centers)
16201015|NCT01386606|Drug|Androxal (enclomiphene citrate)|"capsule oral
~1X a day 6 weeks"
16201016|NCT01386606|Drug|Testosterone|"topical gel
~1X a day 6 weeks"
16201017|NCT01386593|Drug|Basel cocktail+(Fluconazole, Ciprofloxacin, Paroxetine)|
16201018|NCT01386593|Drug|"Basel Cocktail"|
16201019|NCT01386593|Drug|Basel cocktail + Rifampicin|
16201020|NCT01386580|Drug|2B3-101|IV every 21 days
16201021|NCT01386580|Drug|Trastuzumab|IV every 21 days
16201022|NCT01386580|Drug|2B3-101 60 mg/m2 every 4 weeks|IV every 28 days
16201023|NCT01386580|Drug|2B3-101 50 mg/m2 every 3 weeks|IV every 21 days
16201024|NCT01386567|Drug|Androxal (enclomiphene citrate)|"capsules oral 1x a day
~1 year"
16201025|NCT01386567|Drug|Testim (topical testosterone)|"topical
~1 tube
~1x a day
~1 year"
16201026|NCT01386554|Drug|Repository Corticotropin Injection|Acthar given SC for 6 months
16201027|NCT01386554|Drug|Placebo|"Placebo contains the same inactive ingredients as that used for H.P. Acthar Gel without the API.
~Placebo given SC for 6 months (80 U two times a week)."
16201028|NCT01386541|Drug|BYK324677|capsules, administered orally
16201029|NCT01386528|Drug|nonacog beta pegol|The patients will receive nonacog beta pegol at screening just prior to and during surgical intervention, administered intravenously (into the vein).
16201030|NCT01386502|Biological|p53: 264-272 peptide|
16201031|NCT01386502|Drug|CT-011|
16201032|NCT01386489|Biological|VRC-HIVDNA016-00-VP|
16201033|NCT01386489|Biological|VRC-HIVADV014-00-VP|
16201034|NCT01386411|Genetic|BRCA testing and questionnaire assessments|If they consent to enroll, they will complete an instrument evaluating their beliefs regarding the value of genetic testing (Assessment 1). After that, they will decide whether they wish to attend an information session on genetic predisposition. If they do, after completing that information session they will complete a follow-up instrument (Assessment 2), and will then decide to either immediately donate a sample for immediate testing, or to defer the decision until after surgery. Women will be given the results of their genetic testing in the context of a standard results counseling session, after which they will continue with clinical care. They will be followed for clinical decision, especially whether or not they undergo CPM.
16201035|NCT01386398|Drug|bortezomib|
16201036|NCT01386398|Drug|vorinostat|
16201037|NCT01386398|Other|laboratory biomarker analysis|
16201171|NCT01385280|Drug|exemestane|Given PO
16201038|NCT01386385|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo 3D-conformal RT
16201039|NCT01386385|Drug|Carboplatin|Given IV
16201040|NCT01386385|Other|Laboratory Biomarker Analysis|Correlative studies
16201041|NCT01386385|Drug|Paclitaxel|Given IV
16201042|NCT01386385|Other|Placebo Administration|Given PO
16201043|NCT01386385|Drug|Veliparib|Given PO
16201044|NCT01386372|Drug|Tolvaptan|Patients will receive full-dose oral tolvaptan therapy up to 1 month after randomization. During the initial 4 days of therapy, the dose of the study drug will be increased from 15 to 30 mg or from 30 to 60 mg according to a regimen designed for slow correction of serum sodium concentrations to 135 mEq/L or more Depending on the serum sodium concentration the dose will be increased or decreased. Patients will then be continued on their maintenance therapy with adjustments allowed to prevent hyponatremia and avoiding hypernatremia. As soon as normal serum sodium levels are achieved in at least two consecutive measurements the dose of the study drug will be progressively tapered according to an individually tailored weaning program
16201045|NCT01386372|Other|Standard therapy|Fluid restriction, normal or hypertonic saline, furosemide.
16201046|NCT01386359|Drug|No Intervention|No Intervention. Subjects are previously treated with Nulojix (belatacept)
16201047|NCT01386346|Drug|Azacitidine|Dose level -1: 50 mg/m2 subcutaneous injection on Day 1-3 of a 21 day cycle. Repeat for a total of 3 cycles. Dose level 1: 75 mg/m2 subcutaneous injection on Day 1-3 of a 21 day cycle. Repeat for a total of 3 cycles. Dose level 2: 75 mg/m2 subcutaneous injection on Day 1-5 of a 21 day cycle. Repeat for a total of 3 cycles.
16201048|NCT01386346|Drug|Oxaliplatin|130 mg/m2 IV on Day 3 or 5 of each 21 day cycle. Repeat for a total of 3 cycles.
16201049|NCT01386346|Drug|Epirubicin|50 mg/m2 IV on Day 3 or 5 of each 21 day cycle. Repeat for a total of 3 cycles.
16201050|NCT01386346|Drug|Capecitabine|625 mg/m2 orally twice daily beginning on Day 3 or 5 and will be taken without interruption for each 21-day cycle.
16201051|NCT01386333|Drug|oxytocin|Patients will be randomized to receive intranasal oxytocin or placebo in a dose escalation paradigm with three dose cohorts: 24IU, 48IU and 72IU of intranasal oxytocin twice daily for 1 week
16201052|NCT01386333|Drug|Saline Nasal Mist|Placebo arm wil receive saline nasal mist sprays matched in number to oxytocin dose cohorts
16201053|NCT01386320|Procedure|Ultrasound guided ankle block|Under ultrasound guidance, block of the tibial nerve, superficial and deep branches of the common peroneal nerve and saphenous nerves will be carried out using 12 mls 0.5% levobupivacaine and 12 mls 0.75% levobupivacaine.
16201054|NCT01386320|Procedure|Medial forefoot block|Using peripheral nerve stimulator guidance, the tibial and common peroneal nerves will be blocked ( plus the saphenous nerve ), using a total of 12 mls 0.75% levobupivacaine and 12 mls 0.5% levobupivacaine.
16201055|NCT01386294|Drug|Tenofovir gel|Tenofovir gel is a clear, transparent, viscous gel at concentrations of 1% formulated in purified water with edentate disodium, citric acid, glycerin, methylparaben, propylparaben, HEC, and pH adjusted to 4-5. Tenofovir gel will be supplies in a 4 ml single use applicator containing approximately 4 grams of gel, equivalent to approximately 40mg of tenofovir.
16201056|NCT01386294|Drug|Universal placebo gel|The placebo gel is an inert gel containing HEC as the gelling agent, purified water, sodium chloride, sorbic acid and sodium hydroxide. Each applicator contains approximately 4ml of placebo gel
16201057|NCT01386281|Drug|E2 transdermal (Julina, BAY86-5435)|Patients in daily life treatment receiving Julina for postmenopausal osteoporosis
16201058|NCT01386268|Biological|Recombinant Factor VIII (Kogenate FS, BAY14-2222)|Patients with diagnosis of hemophilia A, treated with KOGENATE FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE FS
16201059|NCT01386255|Drug|Baclofen|The final baclofen dose will be 0.7 mg/kg (to a maximum of 40 mg/day) divided in three doses.
16201060|NCT01386255|Drug|placebo|placebo. No other names
16201061|NCT01386242|Drug|Recombinant anti-tumor and anti-virus protein for injection|Recombinant anti-tumor and anti-virus protein for injection,10μg,im,twice per week for first 2 weeks, followed by 20μg, im, twice per week after 2 weeks
16201062|NCT01386242|Drug|Recombinant anti-tumor and anti-virus protein for injection|Recombinant anti-tumor and anti-virus protein for injection, 10μg/1mL,im,three times per week for first 2 weeks, followed by 20μg,im, three times per week after 2 weeks.
16201063|NCT01386242|Other|Saline Injection|Saline Injection, 1mL, im,three times per week
16201064|NCT01386242|Drug|Recombinant anti-tumor and anti-virus protein for injection|Recombinant anti-tumor and anti-virus protein for injection, 10μg, im, three times per week for first week, followed by 20μg for two weeks, and followed by 30μg for a week, and followed a maintenance dose of 40μg, the frequency of administration is three times per week.
16201065|NCT01386229|Drug|Ketamine|During standard anesthesia induction with fentanyl and midazolam, ketamine 2 mg/kg IV will be administered
16201066|NCT01386229|Drug|Etomidate|During standard anesthesia induction with fentanyl and midazolam, etomidate 3 mg/kg IV will be administered
16201067|NCT01386216|Device|Magellan®|Autologous Bone Marrow Cell Concentrate Prepared Using the Magellan System to be injected into the ischemic muscle tissue at 0.5 cc/injection for a total of 12-20 cc.
16201068|NCT01386190|Other|Exercise/Social Behavioral|Both the control and the intervention groups will be guided in implementing structured social interaction. In the intervention group, the structured interaction will incorporate augmented physical activities, while in the control group, the structured interaction will consist of predominantly social activities such as the caregiver reading or singing to the baby. The duration of the structured activities for both groups will be the same.
16201069|NCT01386177|Drug|3,4-Methylenedioxymethamphetamine|125 mg per os, single dose
16201070|NCT01386177|Drug|Doxazosin|"3 days (-64h) before MDMA: 4 mg doxazosin per os. 2 days (-40h) before MDMA: 8 mg doxazosin per os.
~1 day (-16h) before MDMA: 8 mg doxazosin per os."
16201071|NCT01386177|Drug|placebo|capsules identical to MDMA or doxazosin
16201072|NCT01386164|Biological|Gardasil|Subjects will receive three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.
16201073|NCT01386164|Biological|Cervarix|Subjects will receive three doses of the study vaccine administered intramuscularly according to a Day 0, Week 6, and Month 6 vaccination schedule.
16201074|NCT01386151|Drug|Keratinocyte Growth factor|KGF will be administered intravenously in a 'collapsed dose' regime of 180ug/kg on day 0 and day 11
16201075|NCT01386151|Drug|Saline placebo|Normal (0.9%) saline will be used as a placebo.
16201076|NCT01386138|Behavioral|Psycho-education|Receive RBT education and peer-support in a group format.
16201077|NCT01386138|Behavioral|Experimental|Receive RBT education and a pro-active counseling method
16201078|NCT01386125|Drug|Mometasone Furoate Nasal Spray (MFNS)|MFNS, 200 mcg BID administered as two 50 mcg sprays in each nostril BID for up to 16 weeks
16201079|NCT01386125|Drug|Placebo for MFNS|Two sprays in each nostril BID for up to 16 weeks
16201080|NCT01386112|Drug|EUR-1100|Active oral medication
16201081|NCT01386112|Drug|placebo|matching placebo
16201082|NCT01386099|Drug|PSN821|Three PSN821 dose groups: PSN821 75mg twice a day, 250mg twice a day and 625mg twice a day for 12 weeks.
16201083|NCT01386099|Drug|Placebo|Placebo twice a day for 12 weeks.
16201084|NCT01386086|Drug|aripiprazole|The starting dose of aripiprazole will be 2 mg and the dose adjusted to a maximum of 15 daily
16201085|NCT01386073|Drug|FreshKote|Three times a day for three months
16201086|NCT01386073|Drug|Systane|three times a day for three months
16201087|NCT01386060|Other|Mindfulness Meditation Training|One-on-one mindfulness meditation training, 6 weeks, 1 1/2 hour training once per week, 30-45 min at-home practice per day.
16201088|NCT01386047|Other|Integrated Clinical Prediction Rule (iCPR)|Integrated clinical prediction rule for Strep Pharyngitis based on Walsh clinical prediction rule (CPR) criteria and rule for Pneumonia based on Hecklering CPR criteria.
16201089|NCT01386034|Drug|Citrulline and placebo|After receiving a 7-day oral supplementation with either citrulline or placebo, each subject will be admitted for a half day, after an overnight fast, and will receive a 5-h intravenous infusion of L-[1-13C]leucine. At regular intervals throughout the isotope infusion, blood will be obtained to measure 13C-enrichment in plasma a-keto-isocaproate, using gas chromatography-mass spectrometry. Simultaneously, 13C-enrichment will be measured in aliquots of expired air CO2 using isotope ratio mass spectrometry, and total CO2 production (VCO2) will be measured using direct calorimetry, respectively. Then the subject take no treatment for 13 days. The study will then be repeated a second time in an identical fashion, after a second 7-day period of oral supplementation with either citrulline or placebo.
16201090|NCT01386008|Device|senfilcon A contact lens|senofilcon A spherical contact lens worn in a daily wear modality
16201091|NCT01386008|Device|investigational enfilcon A|investigational enfilcon A, worn daily wear modality
16201092|NCT01385995|Device|Continuous Positive Airway Pressure (CPAP) (Philips-Respironics RemStar Pro® CPAP)|Subjects will be randomized to 8 weeks of CPAP or sham-CPAP, followed by the alternate therapy after a one month wash-out.
16201093|NCT01385995|Device|Sham-Continuous Positive Airway Pressure (CPAP) (Philips-Respironics)|Subjects will be randomized to 8 weeks of CPAP or sham-CPAP, followed by the alternate therapy after a one month wash-out.
16201094|NCT01385982|Other|Actionable Test Result Management/Standardization|The intervention includes enterprise-wide standardization of actionable test result (ATR) definitions with stratification of significant results into alert levels, expected timeframes for clinician responses, a set of policies for ATR follow-up, metrics to measure ATR management and performance feedback.
16201095|NCT01385969|Device|Standard inflation of LMA cuff|LMA cuff will be inflated per standard practice with a syringe and resulting cuff pressure will be measured by manual palpation of the cuff per standard practice.
16201096|NCT01385969|Device|Pressure check with syringe recoil|LMA cuff will be inflated per standard practice with a syringe and resulting cuff pressure will be measured by syringe recoil
16201097|NCT01385969|Device|Pressure check by pressure transducer|LMA cuff will be inflated per standard practice with a syringe and resulting cuff pressure will be measured by pressure transducer.
16201098|NCT01385956|Drug|SOM 230 LAR|We will attempt dose escalation starting at a lower level 1 of 40 mg since we are using SOM 230 LAR in combination with gemcitabine for the first time.
16201099|NCT01385956|Drug|Gemcitabine|Fixed dose: 1000mg/m^2 weekly x3 then 1 week off
16201100|NCT01385930|Behavioral|Lifestyle counseling|Lifestyle counseling
16201101|NCT01385891|Drug|Clofarabine VP 16 ciclophospahamide|Clofarabine intravenously 2-hour infusion,dose 40 mg/m2, followed by Etoposide (VP 16)100 mg/m2 i.v. over 2 hours and Cyclophosphamide 440 mg/m2 i.v. over 1 hour
16201102|NCT01385878|Procedure|Microcoaxial Phacoemulsification|Phacoemulsification through small clear corneal incision
16201103|NCT01385878|Procedure|Microcoaxial Phacoemulsification|Phacoemulsification through clear corneal incision
16201104|NCT01385878|Procedure|Microcoaxial Phacoemulsification|Microcoaxial Phacoemulsification through 1.8mm incision
16201105|NCT01385878|Procedure|Microcoaxial Phacoemulsification|Microcoaxial phacoemulsification through 2.2mm incision
16201106|NCT01385865|Dietary Supplement|Mulberry leaf extract|18 tablets/day (6 tablets/serving x 3servings/day, mulberry leaf extract 336mg/1 tablet (800mg), 1-Deoxynojirimycin 4.3mg/1 g mulberry leaf extract), Duration: 4 weeks
16201107|NCT01385865|Dietary Supplement|Placebo|18 tablets/day (6 tablets/serving x 3servings/day, lactose 511mg/1 tablet (650mg)), Duration: 4 weeks
16201108|NCT01385852|Procedure|microcoaxial phacoemulsification|conventional longitudinal ultrasound
16201109|NCT01385839|Procedure|Hair transplantation|Hair transplantation is a procedure in which donor hair follicles are harvested from a section of a patient's scalp, and transplanted in another bald recipient area, at which time it will take root and continue to grow. Hairs generally continue to grow indefinitely.Hair transplant involves mild sedation with Valium, followed by local anesthesia of the donor and recipient areas. Donor hair is harvested using a scalpel to cut narrow strips of hair bearing areas. Follicular units are obtained by slicing the donor tissue into naturally occurring groupings. The follicular units are placed into holes made by a hypodermic needle in the alopecia areata affected areas of the subject. Grafts are held in place by coagulated blood. A bandage is applied after the procedure and left in place over night. The following day, the patient returns for follow up, bandage removal, cleansing, hair washing, and a check up.
16201110|NCT01385839|Procedure|Hypodermic needle irritation|In the areas which are simply treated with irritation with the hypodermic needle, the procedure is the same, except no follicular units are placed into the holes.
16201111|NCT01385826|Drug|Anti-tumor necrosis factor alpha monoclonal antibody|The dose of adalimumab will be 40 mg for children age 13 and over and for children younger than 13 adalimumab 24 mg per m2 BSA (up to a maximum total body dose of 40 mg).
16201112|NCT01385826|Drug|placebo|Patients will receive 4 injections of placebo on D0, D14, D28, and D42 with assessment of the primary endpoint at M2
16201113|NCT01385800|Biological|ToleroMune Grass|Intradermal injection 1 x 8 administrations 2 weeks apart
16201114|NCT01385800|Biological|Placebo|Intradermal injection 1 x 8 administrations 2 weeks apart
16201115|NCT01385774|Procedure|Percutaneous Transluminal Angioplasty|The Percutaneous Transluminal Angioplasty (PTA) procedure will be performed by an experienced interventional radiologist using a conventional guide wire and balloon catheter technique. A stent will be placed in cases in which the residual mean pressure gradient is greater than 10 mmHg across the treated site or when more than 30% stenosis after the procedure is detected. All PTA patients are encouraged perform at least three walking sessions every day.
16201116|NCT01385774|Other|Supervised Exercise Therapy|Supervised Exercise Therapy (SET) will take place in the hospital or community based according to the guidelines of the Dutch Society for Physiotherapists. The duration of the treatment will be at least 6 months and with a frequency of 2 times a week for at least 60 minutes and an intensity near maximum pain barrier (defined as pain of which it is not possible to be distracted). The frequency of the training will decrease after 3 months and the patients will receive homework, make a plan and keep a log of their exercise activities. Furthermore the program consists of walking pattern improvement and enhancement of endurance and strength. All SET patients are encouraged to perform at least three walking sessions every day on their own.
16201117|NCT01385761|Device|Laryngeal Mask Airway|Each child will be randomized to either receiving the LMA or air-Q ILA-SP as their supraglottic airway device for primary airway maintenance.
16201118|NCT01385761|Device|air-QTM Intubating Laryngeal Airway|Each child will be randomized to either receiving the LMA or air-Q ILA-SP as their supraglottic airway device for primary airway maintenance.
16201119|NCT01385748|Drug|Clonidine Lauriad® 50µg|50µg muco-adhesive buccal tablet once day every day up to 8 weeks
16201120|NCT01385748|Drug|Clonidine Lauriad® 100µg|100µg muco-adhesive buccal tablets, once a day, every day up to 8 weeks
16201121|NCT01385748|Drug|Placebo Lauriad®|placebo muco-adhesive buccal tablets, once a day, every day up to 8 weeks
16201122|NCT01385735|Drug|Rasagiline|Azilect Group: Dose: 1 mg per day, 12 week (84 days) duration
16201123|NCT01385735|Drug|Placebo|Placebo 1 Tbl per day, 12 week (84 days) duration
16201124|NCT01385696|Device|Genuair® (Almirall S.A.)|Inhaler with only placebo, once daily, 14 days
16201125|NCT01385696|Device|HandiHaler® (Boehringer Ingelheim's)|Inhaler with only placebo, once daily, 14 days
16201126|NCT01385683|Drug|Dabigatran then dabigatran and clarithromycin|D4 : dabigatran 300 mg (4 tablets) one time. D8 to D10 : Clarithromycin 500mg (1 tablet) twice daily. D11 : Clarithromycin 500mg (1 tablet) + 300mg dabigatran (4 tablets)
16201127|NCT01385683|Drug|Clarithromycin and dabigatran then dabigatran|D1 to D3 : Clarithromycin 500mg (1 tablet) twice daily. D4 : Clarithromycin 500mg (1 tablet) + 300mg dabigatran (4 tablets). D11 : dabigatran 300 mg (4 tablets) one time.
16201128|NCT01385670|Device|Transcatheter PFO closure with the SeptRx Intrapocket PFO Occluder (IPO)|Transcatheter PFO closure
16201129|NCT01385657|Drug|Placebo|A total of 4 doses were administered.
16201130|NCT01385657|Drug|Dupilumab|A total of 4 doses were administered.
16201131|NCT01385657|Other|Background treatment|Participants were required to apply stable doses of an additive-free, basic bland emollient on the affected areas of the skin twice daily throughout the study.
16201132|NCT01385644|Other|Placental MSC|MSC will be derived from mothers donating their term placenta for clinical trial research purposes at Mater Mothers Hospital, Brisbane. The donation, isolation and expansion of placental-derived MSC for research purposes has been approved by the Mater Health Services (MHS) Human Research Ethics Committee (Reference No. 1292A). These volunteer donor mothers are unrelated to and will be HLA-unmatched with the IPF recipients.
16201133|NCT01385631|Drug|Ezetimibe|100 patients with ST elevation myocardial infarction are randomized 1:1 to either placebo or Ezetimibe 10 mg per day in addition to treatment with Atorvastatin 80 mg in both arms.
16201134|NCT01385631|Drug|Placebo|100 patients with ST elevation myocardial infarction are randomized 1:1 to either placebo or Ezetimibe 10 mg per day in addition to treatment with Atorvastatin 80 mg in both arms.
16201135|NCT01385592|Drug|AFQ056|
16201136|NCT01385592|Drug|Placebo|
16201137|NCT01385579|Other|Care manager outreach|Patients assigned to the intervention arm are mailed a letter informing them that they are due for colorectal cancer screening, educational information about colorectal cancer screening, a fecal occult blood testing (FOBT) kit, and directions on how to complete and return the FOBT kit. Patients who do not respond to the mail outreach received up to 3 attempts at telephone outreach by the care manager.
16201138|NCT01385566|Biological|ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Subcutaneous|One 0.65 mL injection subcutaneously on Day 1
16201139|NCT01385566|Biological|ZOSTAVAX™ (Zoster Vaccine Live) 1/3 Dose Subcutaneous|One approximately 0.22 mL injection subcutaneously on Day 1
16201140|NCT01385566|Biological|ZOSTAVAX™ (Zoster Vaccine Live) Full Dose Intradermal|Two intradermal injections of approximately 0.15 mL each on Day 1
16201141|NCT01385566|Biological|ZOSTAVAX™ (Zoster Vaccine Live) Partial Doses Intradermal|One intradermal injection of approximately 0.1 mL on Day 1
16201142|NCT01385566|Biological|Full Dose Intradermal Placebo|Two intradermal placebo injections of approximately 0.15 mL each on Day 1
16201143|NCT01385566|Biological|Intradermal Placebo|One intradermal placebo injection of approximately 0.1 mL on Day 1
16201144|NCT01385553|Behavioral|Fathers for Change|FATHERS FOR CHANGE comprises 16, 60 minute sessions of treatment utilizing components of three evidence based practices: SADV-Cognitive Behavioral Therapy, Behavioral Couple Therapy and Child-Parent Psychotherapy. The goals of the intervention are: 1) decreased substance abuse and IPV by teaching coping and anger management skills, 2) improved communication and increased problem solving around shared parenting 3) parenting education including child development and the impact of violence on children, 4) discussion of discipline practices and development of behavior modification or positive reinforcement plans, and 5) attachment focused parent-child play sessions to coach fathers in play with their children and process traumatic experiences.
16201172|NCT01385280|Other|laboratory biomarker analysis|Correlative studies
16201173|NCT01385280|Other|enzyme-linked immunosorbent assay|Correlative studies
16201264|NCT01384734|Drug|Atazanavir 300 mg|Capsules, Oral, 300 mg, Once daily, 96 weeks
16201145|NCT01385553|Behavioral|Individual Drug Counseling|Individual drug counseling focuses on the symptoms of drug addiction and related areas of impaired functioning and the content and structure of the patient's ongoing recovery program. This model of counseling is time limited and emphasizes behavioral change. It gives the patient coping strategies and tools for recovery and promotes 12-step ideology and participation. The primary goal of addiction counseling is to assist the addict in achieving and maintaining abstinence from addictive chemicals and behaviors. The secondary goal is to help the addict recover from the damage the addiction has caused in his or her life.
16201146|NCT01385540|Behavioral|Task-Based Functional Magnetic Resonance Imaging (fMRI)|Individuals will be shown a target, which is randomly selected from 12 objects designated as targets, before each scan. The target for a scan will never appear as a non-target object in another scan. Per established protocol, individuals will fixate on a central cross prior to imaging. Individuals will press a MR-compatible button when they detect the target. Target objects only appear in the cued stream. Cues, a filled red square, are programmed to occur, on average, every 2.06, 4.12, or 6.18 seconds within a temporal window of ± 400 milliseconds centered on those values.
16201147|NCT01385527|Behavioral|Weekly Internet survey|Parents will complete a weekly online survey about medication use.
16201148|NCT01385527|Drug|Topical Triamcinolone|Topical triamcinolone to all affected areas once daily
16201149|NCT01385501|Other|Video intervention along with educational hand out|The interventional group will be shown an 8 minute video addressing common concerns of vaccine hesitant parents. Then, they will be provided with a handout describing how to find accurate vaccine information on the internet and a handout on more common questions from vaccine hesitant parents.
16201150|NCT01385488|Behavioral|self-monitor arm volume|bioelectrical impedance
16201151|NCT01385475|Behavioral|RT|8 week RT Intervention
16201152|NCT01385449|Procedure|interscalene catheter|interscalene catheter
16201153|NCT01385449|Procedure|interscalene block|interscalene block
16201154|NCT01385423|Drug|Preparative Regimen|Fludarabine 25 mg/m^2 x 5 days start day -6, Cyclophosphamide 60 mg/kg x 2 days on day -5 and -4 (*if < 4 months from prior transplant, omit day -4 dose)
16201155|NCT01385423|Biological|Intravenous Recombinant Human IL-15 (rhIL-15)|IL-15 at assigned dose (0.25, 0.5, 0.75 1, 2 and 3 mcg/kg for 3 to 6 patients) intravenously (IV) over 30 minutes once a day beginning day +1 and continuing for 12 doses
16201156|NCT01385410|Behavioral|Peer mother support for continued exclusive breastfeeding|Peer counselling on breastfeeding beginning in third trimester and continuing until 3 months postpartum
16201157|NCT01385397|Other|Preceptorship and virtual community|
16201158|NCT01385384|Device|NeuRx RA/4 diaphragmatic pacemaker|"Patients will be implanted with 4 intramuscular electrodes, 2 in each hemi-diaphragm, using laparoscopic techniques.
~The abdominal cavity is inflated with CO2 and 4 ports are inserted: one for optics, 2 for a probe containing a temporary electrode for mapping the diaphragm and the electrode insertion tool, and a smaller one for the output wires of the electrodes of the abdominal cavity. The intra-abdominal pressure variation during the stimulation test (mapping) will be measured externally by one of the ports.
~Sites that provide the optimal response (greater region and magnitude) are noted.
~Once the optimal site for electrode placement is identified two intramuscular electrodes are deployed in each hemi-diaphragm. The guide wires will come out of the peritoneum through the port placed in the xiphoid region. An additional electrode is placed subcutaneously in the upper abdomen. The instruments and ports are then removed and the incision sites closed."
16201159|NCT01385371|Biological|Grass (Phleum pratense) pollen allergen extract|One dissolving tablet sublingually once daily
16201160|NCT01385371|Biological|Placebo for SCH 697243|One dissolving tablet sublingually once daily
16201161|NCT01385358|Procedure|Thoracoscopically Assisted Surgical Ablation|Surgical AF ablation including pulmonary vein isolation, gananglionated plexi ablation +/- LAA excision/exclusion.
16201162|NCT01385358|Procedure|Catheter Ablation|In this arm, study subjects will undergo conventional catheter ablation as their index procedure. This will include pulmonary vein isolation, linear and electrogram based ablation.
16201163|NCT01385345|Drug|Vitamin D3 cholecalciferol|High dose Vitamin D3 (200,000 units followed by 100,000 units x 3 over 6 months) plus daily 1,000 units Vitamin D3 per day vs only daily 1,000 units Vitamin D3 per day
16201164|NCT01385332|Procedure|Early luteal phase|We will administer in the tenth day of the cycle 0.25mg/day of ganirelix until the estradiol levels will be less than 60pgr/mL. Then, we'll start a standard protocol of controlled ovarian hyperstimulation beginning with 150 UI/day. At 6th day of stimulation we'll begin with the antagonist.
16201165|NCT01385332|Procedure|Late follicular phase -COH-|We will administer in the 20th day of the cycle 0.25mg/day of ganirelix until the estradiol levels will be less than 60pgr/mL. Then, we'll start a standard protocol of controlled ovarian hyperstimulation beginning with 150 UI/day. At 6th day of stimulation we'll begin with the antagonist.
16201166|NCT01385319|Device|Bare metal stent implantation|"After BMS implantation the duration of dual anti-platelet therapy is a function of the clinical presentation and the bleeding risk a given patient as follows:
~Clopidogrel will be given for 1 month after PCI if indication to the procedure is stable coronary artery disease or for at least 6 month if indication to the procedure is ACS, including STEMI or NSTEACS. At discretion of the treating physician, prasugrel or ticagrelor may replace clopidogrel in ACS patients.
~Patients recruited in the study due to high bleeding risk will receive clopidogrel for at least 30 days.
~Patients recruited in the study due to high thrombosis risk will receive clopidogrel monotherapy life long or DAPT for at least 1 month."
16201167|NCT01385319|Device|zotarolimus eluting stent|"After ZES implantation the duration of dual anti-platelet therapy is a function of the clinical presentation and the bleeding risk a given patient (i.e. identical to criteria set out for BMS patients) as follows:
~Clopidogrel will be given for 1 month after PCI if indication to the procedure is stable coronary artery disease or for at least 6 month if indication to the procedure is ACS, including STEMI or NSTEACS. At discretion of the treating physician, prasugrel or ticagrelor may replace clopidogrel in ACS patients.
~Patients recruited in the study due to high bleeding risk will receive clopidogrel for at least 30 days.
~Patients recruited in the study due to high thrombosis risk will receive clopidogrel monotherapy life long or DAPT for at least 1 month."
16201168|NCT01385306|Device|AlphaCore System|Non-invasive neurostimulation of the vagus nerve
16201169|NCT01385293|Drug|BKM120|BKM120 at the maximum tolerated dose (MTD) of 100mg orally daily
16201170|NCT01385280|Biological|therapeutic estradiol|Given orally (PO)
16201174|NCT01385267|Procedure|aspiration of amniotic fluid|a sample of amniotic fluid will be drawn from the amniotic sac of Twin A and Twin B. Each amniotic sac will be aspirated by the obstetrician and sent to the laboratory for determination of fetal lung maturity index and lamellar body count.
16201175|NCT01385241|Behavioral|Ipod video|This group will be asked to watch the video on their Ipod Touch in its entirety at least once per week during the first four weeks of the study, and as often as desired in weeks 5-12. The participants will be asked to record the times viewed and their feelings/comments in a viewing log, and will be given surveys at 30 and 90 days.
16201176|NCT01385228|Drug|Pazopanib|"Dose Level Xa - daily administration of pazopanib on days 1 through 21 starting at 400mg with a maximum dose of 1000mg."
16201177|NCT01385228|Drug|Docetaxel|Docetaxel given IV on Day 1 starting dose 60mg/m2 increase to 75mg/m2
16201178|NCT01385228|Drug|Pazopanib|"Dose Level Xb - daily administration of pazopanib on days 3 through 19 starting at 400mg with a maximum dose of 1000mg."
16201179|NCT01385228|Drug|Prednisone|5mg Prednisone given twice daily days 1-21.
16201180|NCT01385228|Drug|Pegfilgrastim|
16201181|NCT01385215|Drug|Fluzone|0.5 ml/15 micrograms
16201182|NCT01385215|Drug|Fluzone|0.5 ml/60 micrograms
16201183|NCT01385202|Device|THERMOCOOL® SMARTTOUCH™ Catheter|AF Ablation
16201184|NCT01385189|Biological|10 μg Na-GST-1/Alhydrogel|3 doses 10 μg Na-GST-1/Alhydrogel administered at 56 day intervals
16201185|NCT01385189|Biological|30 μg Na-GST-1/Alhydrogel|3 doses 30 μg Na-GST-1/Alhydrogel administered at 56 day intervals
16201186|NCT01385189|Biological|100 μg Na-GST-1/Alhydrogel|3 doses 100 μg Na-GST-1/Alhydrogel administered at 56 day intervals
16201187|NCT01385189|Biological|10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)|3 doses 10 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals
16201188|NCT01385189|Biological|30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg)|3 doses of 30 μg Na-GST-1/Alhydrogel/GLA-AF (1 μg) administered at 56 day intervals
16201189|NCT01385189|Biological|30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)|3 doses 30 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals
16201190|NCT01385189|Biological|100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg)|3 doses 100 μg Na-GST-1/Alhydrogel/GLA-AF (5 μg) administered at 56 day intervals
16201191|NCT01385176|Device|Implant of investigational device system|Vagus nerve stimulation lead was wrapped around the right cervical vagus nerve and then connected to a stimulator permanently implanted in the right pectoral region.
16201192|NCT01385176|Procedure|Titration during the randomization phase|Amplitude of the chronically delivered vagus nerve stimulation in the experimental arm was adjusted to the highest tolerable by patient value. No chronically delivered vagus nerve stimulation in the control arm during the randomization phase.
16201193|NCT01385176|Procedure|Titration after the randomization phase|Amplitude of the chronically delivered vagus nerve stimulation was adjusted to the highest tolerable by patient value in all patients in both arms of the study.
16201194|NCT01385176|Diagnostic Test|Blood Draw|Blood draw before implant and 6 months after implant at the end of the randomization phase.
16201195|NCT01385163|Behavioral|Treatment as usual|Standard psychosocial counseling
16201196|NCT01385163|Behavioral|Voluntary Savings/Loans Assoc|economic intervention for group savings and loans
16201197|NCT01385163|Behavioral|Cognitive Processing Therapy|group 12 session intervention
16201198|NCT01385150|Genetic|mutation analysis|
16201199|NCT01385150|Genetic|protein analysis|
16201200|NCT01385150|Other|laboratory biomarker analysis|
16201201|NCT01385150|Other|liquid chromatography|
16201202|NCT01385150|Other|mass spectrometry|
16201203|NCT01385137|Dietary Supplement|omega-3 fatty acid|Given orally
16201204|NCT01385137|Other|placebo|Given orally
16201205|NCT01385124|Drug|Oral Cannabidiol|Cannabidiol will be dissolved in oil to a predefined concentration. Patients will be given oral cannabidiol 10 mg twice daily from conditioning starting day and until day +30 after allogeneic transplantation.
16201206|NCT01385111|Procedure|EUS-B-FNA followed by EBUS-TBNA|EUS-B-FNA will be performed followed by EBUS-TBNA when additional needle aspiration is necessary after EBUS-TBNA.
16201207|NCT01385111|Procedure|EBUS-TBNA followed by EUS-B-FNA|EBUS-TBNA will be performed followed by EUS-B-FNA when additional needle aspiration is necessary after EUS-B-FNA
16201208|NCT01385098|Dietary Supplement|Vitamin D3 and Calcium|1500 mg of calcium citrate plus 1000 IU of vitamin D3 and 1000 IU of vitamin D3 bariatric supplements per day
16201209|NCT01385072|Biological|Double matched sibling transplantation|"Patients with poor risk active acute leukemia and who have 2 matched sibling donors can be included. Patients' conditioning may be myeloablative or non-myeloablative. Both matched donors will be mobilized with G-CSF and their peripheral blood stem cells will be collected on day 0.Equal numbers of CD34+ cells from both donors will be transfused to the patient.
~Patients will be followed for engraftment kinetics, chimerism, GVHD rate, severity and response to treatment, relapse rates, DFS and OS."
16201210|NCT01385059|Drug|axitinib|Given PO
16201211|NCT01385059|Procedure|therapeutic conventional surgery|Undergo prostatectomy and pelvic lymph node dissection
16201212|NCT01385059|Other|enzyme-linked immunosorbent assay|Correlative studies
16201213|NCT01385059|Other|laboratory biomarker analysis|Correlative studies
16201214|NCT01385046|Behavioral|Project Fit|physical activity and nutrition education
16201215|NCT01385033|Drug|[18F]MK-3328|IV dose of ~150 megabecquerel (MBq) [18F]MK-3328
16201216|NCT01385020|Drug|Gemfibrozil & red yeast rice (LipoCol)|The effect of gemfibrozil on the pharmacokinetics of red yeast rice capsule (LipoCol) after administering single-dose combination in healthy subjects.
16201259|NCT01384734|Drug|BMS-663068 600 mg|Tablets, Oral, 600 mg, once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose
16201260|NCT01384734|Drug|BMS-663068 1200 mg|Tablets, Oral, 1200 mg, once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose
16201261|NCT01384734|Drug|Raltegravir 400 mg|Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose
16201262|NCT01384734|Drug|Tenofovir 300 mg|Tablets, Oral, 300 mg, Once daily (QD), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose
16201263|NCT01384734|Drug|Ritonavir 100 mg|Tablets, Oral, 100 mg, Once daily, 96 weeks
16201217|NCT01385007|Behavioral|Preventing Aggression in Veterans with Dementia (PAVeD)|PAVeD-Telephone consists of three components: pain-management strategies, improvement of patient-collateral communication skills, and behavioral activation through increased pleasant activity planning. The intervention will be primarily geared toward the caregiver; but patients may be involved in some modules, depending on their dementia severity and willingness. The goal of the sessions is to prevent aggression in veterans with dementia. The sessions will include didactics, skill-building, and discussion. Participants will also be provided a copy of the book, Pain Management for Older Adults: A Self-help Guide, as an additional resource for optional reading on the topics covered in the intervention. The intervention is proposed to include six to eight sessions of weekly treatments, lasting 30 minutes to 45 minutes, specifically developed to address the recognition and management of pain in persons with dementia.
16201218|NCT01384994|Drug|Folic Acid|400 mg/m2, 2h infusion, d1, q2w
16201219|NCT01384994|Drug|5-FU|400 mg/m2 bolus iv, d1, q2w
16201220|NCT01384994|Drug|5-FU|2400 mg/m2 46-h infusion, d1-2, q2w
16201221|NCT01384994|Drug|Oxaliplatin|85 mg/m2 d1, q2w
16201222|NCT01384994|Drug|Panitumumab|6 mg/kg BW every 2 weeks
16201223|NCT01384994|Drug|Panitumumab|Panitumumab maintenance phase (3 months) 9mg/kg BW every 3 weeks
16201224|NCT01384994|Drug|Folic Acid|400 mg/m2, 2-h infusion, d1, q2w
16201225|NCT01384994|Drug|5-FU|400 mg/m2 bolus iv, d1, q2w
16201226|NCT01384994|Drug|5-FU|2400 mg/m2 46-h infusion, d1-2, q2w
16201227|NCT01384994|Drug|Oxaliplatin|85 mg/m2 d1, q2w
16201228|NCT01384981|Procedure|pulmonary rehabilitation|
16201229|NCT01384968|Dietary Supplement|beetroot juice|170 mL beetroot juice (Beet It, James White drinks Ltd).
16201230|NCT01384942|Behavioral|Meaning-Based Bereavement Group|A 12 week bereavement counselling group with tasks and themes that focus on re-constructing meaning following death.
16201231|NCT01384942|Behavioral|Conventional Bereavement Group|An 8 week traditional bereavement group that follows a more conventional approach to grief support.
16201232|NCT01384916|Behavioral|Yoga|2x weekly
16201233|NCT01384916|Behavioral|Healthy Living Workshop|2x weekly
16201234|NCT01384903|Drug|KW-3357|Intravenous infusion once a day
16201235|NCT01384903|Drug|Plasma-derived antithrombin|Intravenous infusion once a day
16201236|NCT01384890|Radiation|VMAT with CBCT|volumetric modulated arc therapy (VMAT) with cone-beam computed tomography (CBCT) position verification
16201237|NCT01384890|Radiation|VMAT with kV-ray|Volumetric modulated arc therapy (VMAT) with kV-ray position verification
16201238|NCT01384877|Drug|Lidocaine|10mg/kg by subcutaneous infusion over 5.5 hours
16201239|NCT01384877|Drug|Placebo (D5W)|Same volume as for lidocaine infusion, identical clear liquid in appearance, given in same device over same time period (5.5 hrs)
16201240|NCT01384864|Drug|proflavine|2-6 ml of 0.01% proflavine
16201241|NCT01384851|Drug|Next Generation Emulsion|One drop both eyes 4 times daily for two weeks
16201242|NCT01384851|Drug|Refresh Dry Eye Therapy|One drop both eyes four times daily for two weeks
16201243|NCT01384851|Drug|Refresh Contacts|One drop both eyes four times daily for two weeks
16201244|NCT01384838|Behavioral|Counseling|Nutritional, lifestyle and sports counseling
16201245|NCT01384838|Behavioral|physical activity|counseling and controlled physical activity
16201246|NCT01384812|Drug|dinoprostone|intravenous injection 0.4 μgr/kg/min for 25 min
16201247|NCT01384812|Drug|isoton sodium chloride|intravenous injection for 25 min
16201248|NCT01384799|Drug|CUDC-101|CUDC-101 will be administered as a 1 hour intravenous infusion three times per week for a one week run-in (week -1) and then as part of the combination treatment on weeks 1-7. If the 225 mg/m2 dose is tolerated in the first cohort, the dose will be increased to 275 mg/m2. If the 225 mg/m2 dose is not tolerated, the dose will be decreased to 175 mg/m2. If 175 mg/m2 is not tolerated the dose will be further decreased to 150 mg/m2.
16201249|NCT01384799|Drug|Cisplatin|Cisplatin will be administered intravenously at a dose of 100 mg/m2 on days 2, 23 and 44 of the seven week combination treatment course.
16201250|NCT01384799|Radiation|Radiation Therapy|The initial target volume encompassing the gross and subclinical disease sites will receive 2.0 Gy per fraction, five fractions per week. The gross disease sites will receive 70 Gy in 35 fractions over seven weeks and the subclinical disease sites will receive 56 Gy in 35 fractions, again over seven weeks.
16201251|NCT01384773|Other|Riboflavin Solution|This solution is used to saturate the corneal stroma prior to its photochemical activation by the IROC UV-X illuminator.
16201252|NCT01384773|Device|UV-X Illumination System|IROC UV-X irradiation system creates a uniform 11 mm circle of UVA light that is focused onto the corneal surface. This system is designed to irradiate the riboflavin saturated cornea with a uniform field of UVA light centered at 365 nm.
16201253|NCT01384760|Behavioral|Lifestyle modification|During the first 4 months, subjects will come for a counseling session weekly and then monthly for the following months. During each counseling session (15 to 20 minutes), the registered dietitian will review the seven-day food diaries and offer recommendations for controlling caloric intake. A varied balanced diet with an emphasis on fruit and vegetables, and low-fat and low calorific products in appropriate portions were encouraged. The registered dietitian will also review the daily activity log sheet to check the exercise adherence and progression set by exercise instructor. Subjects will be encouraged to do 30 minutes aerobic exercise two to three times a week.
16201254|NCT01384760|Behavioral|Simple lifestyle advice|Subjects in control group will receive simple lifestyle advice from a clinician at baseline and month 6. This will be a brief discussion about the general health risk associated with OSA and importance of balanced diet. Subjects are encouraged to perform regular 30-minute exercise 2 to 3 times per week. This is to resemble routine clinical practice.
16201255|NCT01384747|Drug|Fimasartan|60-120mg/day (target dose) of Fimasartan will be administered for the study period (till the follow-up angiography)
16201256|NCT01384747|Drug|Placebo|60-120mg/day (target dose) of Placebo will be administered for the study period (till the follow-up angiography)
16201257|NCT01384734|Drug|BMS-663068 400 mg|Tablets, Oral, 400 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose
16201258|NCT01384734|Drug|BMS-663068 800 mg|Tablets, Oral, 800 mg, twice daily (BID), 24+ weeks until optimal dose is selected, or 96 weeks if optimal dose
16202060|NCT01378364|Drug|AbGn-168H|single medium dose of AbGn-168H s.c.
16201265|NCT01384708|Drug|proflavine|1-10 ml of proflavine (derived form dissolving 10mg proflavine hemisulfate USP in 100 ml sterile water)
16201266|NCT01384695|Drug|Fluorescein|fluorescent contrast agent, Fluorescein 5ml
16201267|NCT01384695|Drug|Proflavine hemisulfate|3 ml of 0.01% proflavine (derived from dissolving 10mg proflavine hemisulfate USP in 100ml sterile water)
16201268|NCT01384682|Drug|Maraviroc|Maraviroc is a marketed drug for the treatment of HIV-infection. Maraviroc will be supplied in two different oral dose forms, 150mg and 300mg given twice a day. The drug will be dosed according to the recommendations in the product label i.e. with PI/r the dose is 150mg bid except, Maraviroc 300mg bid can be used at the discretion of the investigator if the PI/r is fosamprenavir/r; those randomised to the 2N(t)RTI arm, will receive Maraviroc 300mg bid. Patients randomised to receive Maraviroc will be provided with bottles of Maraviroc which contain a 30-day supply.
16201269|NCT01384656|Drug|GIK solution|Patients receive 0.3 ml/kg/hr GIK solution or the same volume of normal saline depending on the group during off-pump coronary bypass surgery. GIK solution consist of 50% glucose, potassium 80 mEq, and regular insulin 325 IU/500ml.
16201270|NCT01384643|Drug|Propofol|Induction of anesthesia: Propofol 1 mg/kg, sufentanil 1.0-3.0 µg/kg and rocuronium 50 mg IV Maintenance of anesthesia (pre CPB): Propofol 120-600 µg ∙ kg-1 ∙ h-1 , sufentanil 0.15-0.3 µg ∙ kg-1 ∙ h-1, vecuronium 8-10 mg/h IV infusion Maintenance of anesthesia (during CPB): Propofol 120-600 µg ∙ kg-1 ∙ h-1 IV infusion Weaning from CPB: Sufentanil 50 µg IV Maintenance of anesthesia (post CPB): Propofol 120-600 µg ∙ kg-1 ∙ h-1 , sufentanil 0.15-0.3 µg ∙ kg-1 ∙ h-1, vecuronium 8-10 mg/h IV infusion Propofol infusion rate is titrated using bispectral index (40-60).
16201271|NCT01384630|Drug|RA-18C3|200 mg subcutaneous injection
16201272|NCT01384617|Procedure|Stapling closure of the pancreatic stump|Echelon 60 with a gold cartridge provide provides precise and uniform wide compression throughout the entire 60mm length with compressible thickness to 1.8mm, which can attach two triple-staggered rows of titanium staples.
16201273|NCT01384617|Procedure|Roux-en-Y anastomosis of the pancreatic stump|end-to-side pancreaticojejunostomy into a retrocolic Roux-en-Y reconstruction. The pancreaticojejunostomy anastomosis is performed in duct-to-mucosa.
16201274|NCT01384591|Drug|N-acetylcysteine|50 mg/kg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
16201275|NCT01384591|Drug|Losartan|25mg/dose. 3 total doses: 1 dose on day 1, 2 doses on day 2.
16201276|NCT01384591|Drug|Placebo losartan|Placebo losartan 3 total doses: 1 dose on day 1, 2 doses on day 2.
16201277|NCT01384591|Drug|Placebo N-acetylcysteine|Placebo N-acetylcysteine 3 total doses: 1 dose on day 1, 2 doses on day 2.
16201278|NCT01384578|Drug|pentoxiphylline and Vitamin E|Patients in cases group (Group 1) will receive pentoxiphylline (PTX) 400 mg thrice daily and vitamin E 800 IU/day.
16201279|NCT01384578|Drug|Vitamin E|Patients in control group will receive vitamin E 800 IU/day
16201280|NCT01384565|Drug|G-CSF+EPO|"Drug: Granulocyte Colony-stimulating Factor (G-CSF) and Erythropoetin (EPO)
~G-CSF (in prefilled syringe) at a dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses), along with Darbopoetin alpha 100 mcg/ week (in prefilled syringe) for 4 weeks (total 4 doses).
~Arms: G-CSF+EPO Drug: Placebo
~Placebo 1 (in prefilled syringe) s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses), along with Placebo 2 every week (in prefilled syringe) for 4 weeks (total 4 doses)."
16201281|NCT01384565|Drug|Placebo|Placebo 1 (in prefilled syringe) s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses), along with Placebo 2 every week (in prefilled syringe) for 4 weeks (total 4 doses).
16201282|NCT01384552|Other|Package Unit Size - Single Serving|Participants will receive a box of twenty-two, 0.9-oz. packages of pretzels. Participants will receive the box of pretzels in the lab on a Thursday or Friday and will take the box of pretzels home for a period of four days. Participants will bring back the box of pretzels to the lab on the following Monday or Tuesday (depending on the day of the initial receipt of pretzels).
16201283|NCT01384552|Other|Package Unit Size - Standard|Participants will receive a box of two, 10-oz. packages of pretzels. Participants will receive the box of pretzels in the lab on a Thursday or Friday and will take the box of pretzels home for a period of four days. Participants will bring back the box of pretzels to the lab on the following Monday or Tuesday (depending on the day of the initial receipt of pretzels).
16201284|NCT01384539|Drug|Cholecalciferol|
16201285|NCT01384539|Drug|Calcitriol|
16201286|NCT01384513|Drug|Fludarabine|Given IV
16201287|NCT01384513|Drug|Busulfan|Given IV
16201288|NCT01384513|Radiation|Total Body Irradiation (TBI)|2 Gy administered as part of the conditioning regimen
16201289|NCT01384513|Biological|Donor Lymphocyte Infusion (DLI)|Undergo DLI
16201290|NCT01384513|Drug|Cyclophosphamide (CY)|Given IV
16201291|NCT01384513|Drug|Tacrolimus|Given IV or PO
16201292|NCT01384513|Drug|Mycophenolate mofetil|Given IV
16201293|NCT01384513|Device|Allogeneic hematopoietic stem cell transplantation|Undergo CD34+ allogeneic PBSCT
16201294|NCT01384513|Procedure|Peripheral blood stem cell transplantation (PBSCT)|Undergo CD34+ allogeneic PBSCT
16201295|NCT01384500|Other|Saline in tube cuff|Use of sterile saline, instead of air, to inflate tracheal tube cuff. Tracheal tube cuffs to be inflated to 22-25 cm H2O.
16201296|NCT01384474|Other|Diffusion of a surgical safety checklist|"Assistance by a local caregiver investigator (i.e., surgeon, anaesthetist, nurse,...) responsible for the implementation of surgical safety checklist within the operatory rooms of his department ;
~A two-step CRM training of surgical teams (i.e., surgeons, anaesthetists, nurses,...) conducted by advisors from the world of air company using video support:
~First month following randomization: a course about the implementation of surgical safety checklist (using online-available WHO short movies and other videos of surgical teams) and core concepts of CRM adapted to the operating room;
~Sixth month following randomization: a feedback to surgical teams aiming at identifying and solving barriers related to the checklist implementation and interpersonal communication
~Written reminders including the systematic presence of an unfilled surgical safety checklist in the patient's medical report, stickers and wall posters in operatory rooms"
16201297|NCT01384448|Procedure|Stress Echocardiography|Stress echocardiography will be performed once. Treadmill stress is default. Patients that cannot exercise will receive dobutamine stress with or without atropine. Definity intravenous contrast will be given when needed.
16201402|NCT01383512|Other|Self rehabilitation|Subject have to realised alone rehabilitation exercises 1 hour per day, 5 days per week during 4 weeks.
16201298|NCT01384448|Procedure|Coronary CT Angiography|64-detector, resting EKG-gated coronary CT angiography will be performed once. Patients with elevated heart rates will be given oral and/or intravenous metoprolol. Prospective gating with reduced tube current will be default. Retrospective gating with tube current modulation will be used in patients with higher heart rates.
16201299|NCT01384435|Drug|KPS-0373|
16201300|NCT01384435|Drug|KPS-0373|
16201301|NCT01384435|Drug|KPS-0373|
16201302|NCT01384435|Drug|KPS-0373|
16201303|NCT01384435|Drug|Placebo|
16201304|NCT01384422|Drug|GLPG0634|
16201305|NCT01384409|Drug|KW-3357|Intravenous infusion once a day
16201306|NCT01384396|Drug|KW-3357|Intravenous infusion once a day
16201307|NCT01384383|Drug|GS-5885|GS-5885 30 mg tablet administered orally once daily
16201308|NCT01384383|Drug|GS-9451|GS-9451 200 mg tablet administered orally once daily
16201309|NCT01384383|Drug|RBV|Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
16201310|NCT01384383|Drug|PEG|Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
16201311|NCT01384344|Other|observational|Observation during a physical exercise
16201312|NCT01384331|Drug|Marvelon|"7 days daily intake of oral capsule containing containing ethinyl oestradiol 30micrograms plus desogestrel 150 micrograms followed by 14 days oral placebo capsules
~21 days daily intake of oral capsules containing ethinyl oestradiol 30micrograms plus desogestrel 150 micrograms
~21 days NuvaRing contraceptive vaginal ring releasing ethinyl oestradiol 15micrograms plus etonorgestrel 120 micrograms dailyleft in situ for 21 days
~21 days daily oral placebo capsules Treatment will be for one cycle of 21 days"
16201313|NCT01384318|Other|Manometer|Measuring cuff pressure
16201314|NCT01384292|Drug|NKTR-118|12.5 mg oral tablet once daily
16201315|NCT01384292|Drug|NKTR-118|25 mg oral tablet once daily
16201316|NCT01384292|Drug|Placebo|Oral treatment
16201317|NCT01384279|Drug|metformin, topiramate|metformin 250 mg/d is gradually increased to 1000 mg/d over four weeks, and topiramate 50 mg/d is gradually increased to 200 mg/d over four weeks
16201318|NCT01384253|Other|²¹²Pb-TCMC-Trastuzumab|The starting dose level will be 200 μCi/m² of ²¹²Pb-TCMC-Trastuzumab. Three to six patients will be treated at each dose level, and dose escalation will proceed if no more than 1 out of 6 patients in a cohort experiences dose limiting toxicity. Six patients will be treated at the maximum tolerated dose.
16201319|NCT01384253|Biological|trastuzumab|4 mg/kg.
16201320|NCT01384240|Drug|Proflavine Hemisulfate|3-ml of 0.01% proflavine(derived from dissolving 10 mg proflavine hemisulfate USP in 100 ml sterile water)
16201321|NCT01384227|Drug|Proflavine Hemisulfate|Proflavine hemisulfate 0.01% (derived from dissolving 10 mg Proflavine Hemisulfate USP in 100 ml of sterile water)
16201322|NCT01384214|Biological|botulinum toxin Type A|750 U at Visit 1
16201323|NCT01384188|Drug|ONO-5334|150 mg for 5 days administered in the morning or in the evening
16201324|NCT01384188|Drug|ONO-5334|150 mg QD for one day. Administered either in the fasted state or after the standard meal or high fat meal.
16201325|NCT01384175|Procedure|intravenous analgesia|Patients received postoperative analgesia with intravenous infusion of fentanyl 10 µg/ml 3-8 mL/h
16201326|NCT01384175|Procedure|epidural infusion|Postoperative analgesia was performed using continuous epidural infusion of ropivacaine 0.2% 3-8 mL/h and fentanyl 2 µg/mL
16201327|NCT01384175|Procedure|patient-controlled epidural analgesia|Postoperative analgesia was performed by continuous epidural infusion of ropivacaine/fentanyl mixture combined with patient-controlled epidural analgesia with ropivacaine/fentanyl bolus 1 mL, lock-out interval 12 min.
16201328|NCT01384162|Drug|sNN0029|ICV infusion
16201329|NCT01384149|Device|external slt|Nd:YAG LASER SLT perilimbal above trabecular meshwork 180 degrees ,100 lasering dots
16201330|NCT01384149|Device|standard slt|Nd:YAG LASER SLT gonioscopic laser treatment
16201331|NCT01384110|Dietary Supplement|Reduction of glycemic index of ingested foods|Oral administration of the experimental lemon tea powder(56.1 g) and the placebo lemon tea powder (55.6 g) dissolved in water. Each participant will receive both treatment in a cross-over protocol design during 2 visits separated by a 2-weeks period. The day before both intervention, participants will consume a standardised meal for the supper.
16201332|NCT01384084|Procedure|POP repair plus mini-sling|"For POP, the anterior vaginal wall is dissected from the bladder to expose a vaginal wall area where the mesh will be attached. The procedure is repeated for the posterior vaginal wall. The sacral promontory surface is prepared and 1 non-reabsorbable sutures are placed into the sacral periosteum.
~A mini sling system will be used, placing a urethral low-tension tape anchored to the obturator muscles bilaterally at the level of tendinous arc. This mini-sling is a polypropylene monofilament mesh."
16201333|NCT01384084|Procedure|POP repair|For POP repair, the anterior vaginal wall is dissected from the bladder to expose a vaginal wall area where the mesh will be attached. The procedure is repeated for the posterior vaginal wall. The sacral promontory surface is prepared and 1 non-reabsorbable sutures are placed into the sacral periosteum. The peritoneum is closed over the meshes.
16201334|NCT01384071|Device|Unstable shoes (MBT)|Wearing unstable (MBT) shoes during 6 weeks
16201335|NCT01384071|Device|Sham intervention (Adidas shoes)|Normal stable shoes (Adidas Bigroar2)
16201336|NCT01384058|Drug|ezetimibe|ezetimibe 10 mg per day for six weeks
16201337|NCT01384058|Drug|simvastatin|Simvastatin 20 mg per day for six weeks
16201338|NCT01384058|Drug|Ezetimibe 10/Simvastatin 20|Ezetimibe 10mg/Simvastatin 20mg per day for six weeks
16201339|NCT01384045|Other|Health promotion outreach|Calling patients who are due for diabetes related services, sending them an interventional letter and assisting them in getting over due serves.
16201340|NCT01384032|Dietary Supplement|Low fat diet|Subjects were asked to consume a low fat diet for 8 weeks. Composition: 28% energy from fat, 8% energy from saturated fat, 55% energy from carbohydrate. Subjects were provided with low fat spread, cooking oil and snacks and asked to consume these in place of normally eaten equivalent foods. Subjects were asked to consume two extra portions of carbohydrate per day (e.g. two slices of bread, equivalent to 35g carbohydrate) and to consume low fat dairy products. Subjects also consumed 2g control oil per day during this period. Control oil comprised palm olein and soybean oil.
16202706|NCT01372787|Other|Quality-of-Life Assessment|Ancillary studies
16201341|NCT01384032|Dietary Supplement|Hgih saturated fat diet|Subjects were asked to consume a high saturated fat diet for 8 weeks. Composition: 38% energy from fat, 18% energy from saturated fat, 45% energy from carbohydrate. Subjects were provided with spread, cooking oil and snacks and asked to consume these in place of normally eaten equivalent foods. Subjects were asked to consume one less portion of carbohydrate per day (e.g. one slice of bread and to consume full fat dairy products. Subjects also consumed 2g control oil per day during this period. Control oil comprised palm olein and soybean oil.
16201342|NCT01384032|Dietary Supplement|High saturated fat diet|Subjects were asked to consume a high saturated fat diet for 8 weeks. Composition: 38% energy from fat, 18% energy from saturated fat, 45% energy from carbohydrate. Subjects were provided with spread, cooking oil and snacks and asked to consume these in place of normally eaten equivalent foods. Subjects were asked to consume one less portion of carbohydrate per day (e.g. one slice of bread and to consume full fat dairy products. Subjects also consumed 6g DHA-rich oil per day during this period providing 3g DHA.
16201343|NCT01384019|Device|distal protection and thrombus aspiration (The GuardWire Plus (Medtronic Inc.))|The GuardWire Plus (Medtronic Inc.): distal balloon occlusion and proximal thrombus aspiration
16201344|NCT01384019|Procedure|c-PCI|conventional PCI without Guard wire
16201345|NCT01383993|Drug|Voriconazole|"Study Days 1: IV voriconazole 9 mg/kg q12h. Study Days 2 to 7: IV voriconazole 8 mg/kg q12h. Study Days 8 to 14: Oral voriconazole (POS) 9 mg/kg q12h with a maximum of 350 mg q12 h.
~Notes:
~If unable to switch to oral medication on Day 8, subjects can continue with IV treatment up to Day 20 before switching to oral dose.
~Only morning oral dose will be given on Day 14 (or the seventh day of oral dosing if IV regimen is extended). However, if clinically indicated, voriconazole treatment may be continued up to Day 30.
~(IV = Intravenous; POS = Powder for oral suspension)"
16201346|NCT01383993|Drug|Voriconazole|"Study Days 1: IV voriconazole 6 mg/kg q12h. Study Days 2 to 7: IV voriconazole 4 mg/kg q12h. Study Days 8 to 14: Oral voriconazole (POS) 200 mg q12h.
~Notes:
~If unable to switch to oral medication on Day 8, subjects can continue with IV treatment up to Day 20 before switching to oral dose.
~Only morning oral dose will be given on Day 14 (or the seventh day of oral dosing if IV regimen is extended). However, if clinically indicated, voriconazole treatment may be continued up to Day 30.
~(IV = Intravenous; POS = Powder for oral suspension)"
16201347|NCT01383980|Dietary Supplement|Continuous Tube Feedings|Tube feeds continued up until elective surgery.
16201348|NCT01383967|Drug|LY2979165|Administered orally
16201349|NCT01383967|Drug|placebo|Administered orally
16201350|NCT01383954|Drug|Diclofenac Gel|Diclofenac gel 4 grams (g) applied topically 4 times daily (QID) to the affected knee(s) for up to 4 weeks. Participants took a maximum dosage of 32 g/day.
16201351|NCT01383941|Drug|Guidelines-based asthma and rhinitis/rhinosinusitis therapy|All participants receive standardized asthma and rhinitis treatment. Asthma and rhinitis medication regimens were based on 1.) the National Asthma Education and Prevention Program (NAEPP) Expert Panel Report -3 (EPR-3) and 2.) the Rhinitis and its Impact on Asthma (ARIA) 2008 guidelines-derived treatment algorithms. References: 1.) J Allergy Clin Immunol 2007; Volume 120, Issue 5, Supplement s93-140. 2.) Allergy 2008; Volume 63, Issue Supplement s86, pages 7-160.
16201352|NCT01383928|Drug|Ixazomib|Ixazomib capsules
16201353|NCT01383928|Drug|Lenalidomide|Lenalidomide capsules
16201354|NCT01383928|Drug|Dexamethasone|Dexamethasone Tablets
16201355|NCT01383902|Other|Food type|1ml, 1ml, 5ml, 50ml, 6ml, 20ml, 60ml and 200ml of chocolate dessert or 1 g, 1 segment (5 segments to a bar) repeated 6 times, 2 bars repeated twice of chocolate bars
16201356|NCT01383889|Other|Physical exercise|Two modalities of exercise will be compared: treading mill and stationary bicycle. Pregnant women enrolled in the study will perform exercise during 20 minutes and will be monitored 20 minutes before, during and 20 minutes after exercise.
16201357|NCT01383876|Behavioral|Collar|Have a hard cervical collar placed in the operating room after surgery. The collar will be removed/exchanged for bathing, grooming, and dressing changes only. It will remain in place for 12 weeks.
16201358|NCT01383876|Behavioral|No Collar|Have a hard cervical collar placed in the operating room after surgery. This will remain in place for 1 to 2 days and be discontinued prior to discharge.
16201359|NCT01383850|Other|NCPAP + standard air|NCAP (SiPAP, Vyasis) was used to administer standard air
16201360|NCT01383850|Other|NCPAP + Heliox|Heliox21 (mixture of Helium 80%- Oxygen 20%) (BOC Medical UK- The Linde group) was stored in 10 liter cylinders and administrated through NCPAP for 12 hours (study period) starting from randomization.
16201361|NCT01383837|Behavioral|STYLEnS|Multifamily group HIV/STI Prevention Intervention or Single Family Dyad (youth and a parent)
16201362|NCT01383837|Behavioral|Health Promotion|Health Promotion Intervention
16201363|NCT01383824|Device|Silent™ Hip|A short cementless, femoral component for use in total hip arthroplasty
16201364|NCT01383811|Other|Moderate Intensity Aerobic Exercise|Individuals in this group will receive moderate intensity exercise in addition to their usual care (Medications+/-Psychotherapy). The moderate intensity exercise program will involve gradual progression in exercise intensity and duration. During the first 4 weeks, participants will attend 3 supervised sessions/week and will be asked to complete at least 2 unsupervised aerobic exercise sessions/week. From weeks 5-8 the number of supervised sessions will be 2/week with at least 3 unsupervised aerobic exercise sessions/week. From weeks 9-12, the participants will have only 1 supervised session/week and will be asked to complete at least 4 unsupervised aerobic exercise sessions/week. In total, the participants will be required to complete 150 minutes of moderate physical activity/week.
16201365|NCT01383811|Other|Wait-list|The wait list/usual care group will continue with their usual standard treatment (Medications +/- Psychotherapy) as before.
16201366|NCT01383798|Dietary Supplement|Placebo|100 mg lactose per day for 6 weeks
16201367|NCT01383798|Dietary Supplement|Ferrous sulfate|100 mg per day of ferrous sulfate for 6 weeks
16201368|NCT01383785|Other|Intracoronary direct injection|"Abciximab bolus dosage: 0,125 mg/kg.
~Group A: Intracoronary full bolus dose of abciximab proximal to thrombus occlusion. The investigators inject the bolus of abciximab by catheter guide before cross the occlusion. This in the normal way in study' laboratory."
16201369|NCT01383785|Other|Intracoronary and distal injection by aspiration device|"Abciximab bolus dosage: 0,125 mg/kg.
~Group B: Half bolus of intracoronary abciximab proximal to thrombus occlusion and the other half distal by aspiration catheter. The investigators inject half of the dose like group A and the other half like group C."
16201370|NCT01383785|Other|Intracoronary distal injection by aspiration catheter device|"Abciximab bolus dosage: 0,125 mg/kg.
~Group C: Distal injection to thrombus occlusion of total bolus dose of abciximab by aspiration catheter. The investigators inject the bolus after cross the occlusion using an aspiration catheter."
16201371|NCT01383772|Procedure|Pan retinal Photocoagulation|All patients with bilateral proliferative diabetic retinopathy requiring bilateral pan retinal photocoagulation will undergo baseline visual field tests prior to commencing laser treatment. These fields will be repeated at 6 months following completion of laser treatment.
16201372|NCT01383759|Drug|Bortezomib/Dexamethasone (BD), Followed By Autologous STC & Maintenance Bortezomib/Dexamethasone|"The treatment has three phases:
~1) Initial treatment phase: This phase consists of 1-3 21-day-cycles of a combination regimen that includes bortezomib 1.3 mg/m2, IV or Subcutaneous Injection (SQ), on days 1, 4, 8, and 11; and dexamethasone 40 mg PO or IV, on days 1, 4, 8, and 11. Stem cell mobilization and HDM/ASCT. Post-ASCT consolidation/maintenance treatment phase: This phase consists of six cycles of bortezomib 1.3 mg/m2, IV or (SQ) with dexamethasone 20 mg PO or IV administered on days 1, 8, 15, and 22 every 12 weeks +/- 2 weeks. Long Term Follow Up will cease when all patients on study have fulfilled the requirements for at least five follow up appointments."
16201373|NCT01383746|Device|Yttrium microsphere injection|Radiation therapy
16201374|NCT01383733|Drug|RO5458640|Multiple ascending doses intravenously, weekly or every 2 weeks or every 3 weeks
16201375|NCT01383720|Device|Lotus Valve System|The Lotus Valve System includes the Lotus Valve, a bovine tissue tri-leaflet bioprosthetic aortic valve, and the Lotus Delivery Catheter for guidance and placement.
16201376|NCT01383707|Drug|5-Fluorouracil (5-FU)|Participants will receive 5-FU 400 mg per meter-squared (mg/m^2) IV dose on Day 1 of each 2 weeks' cycle followed by 2400 mg/m^2, continuous infusion over 46 hours up to 12 cycles.
16201377|NCT01383707|Drug|Bevacizumab|Participants will receive 5 mg/kg bevacizumab IV dose on Day 1 of each 2 weeks' cycle up to Cycle 5 and thereafter cycles 7 to 12; followed by maintenance therapy of 5 mg/kg IV every 2 weeks up to 52 weeks (26 cycles).
16201378|NCT01383707|Drug|Levofolinic acid|Participants will receive levofolinic acid 200 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle up to 12 cycles.
16201379|NCT01383707|Drug|Oxaliplatin|Participants will receive oxaliplatin 85 mg/m^2 IV infusion over 2 hours on Day 1 of each 2 weeks' cycle up to 12 cycles.
16201380|NCT01383694|Drug|Piperine|
16201381|NCT01383681|Other|No treatment|There was no treatment in this study.
16201382|NCT01383668|Drug|sirolimus|Given PO
16201383|NCT01383668|Drug|gold sodium thiomalate|Given IM
16201384|NCT01383668|Other|pharmacological study|Correlative studies
16201385|NCT01383668|Genetic|RNA analysis|Correlative studies
16201386|NCT01383668|Genetic|polymerase chain reaction|Correlative studies
16201387|NCT01383655|Drug|Magnesium Sulfate|i.v. magnesium 40mg/kg in 20 min
16201388|NCT01383655|Drug|Placebo|NaCl
16201389|NCT01383642|Other|No intervention, observational study|
16201390|NCT01383629|Behavioral|Counselling|Preoperative counselling
16201391|NCT01383616|Device|Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA)|A Jamshidi Crown Bone Biopsy Needle (Cardinal Health; Dublin, OH) was then introduced through the incision into the pedicle, and advanced through the pedicle into the center of the vertebral body using a mallet at a 30 to 45 degree angle relative to the AP axis. A guidewire was then placed through the Jamshidi needle, and the needle removed. A series of dilating cannulae were then advanced over the guidewire until a working cannula was in place. A 15 millimeter (mm) or 20 mm bone tamp (Kyphon Inc; Sunnydale, CA) was then introduced into the vertebral body via the cannula and inflated until the balloon was in contact with the subchondral plate, lateral vertebral body wall, or anterior cortex of the vertebral body. The balloon was then deflated and removed. Subsequently, cement was injected into the cavity and allowed to harden.
16201392|NCT01383603|Biological|Cat-PAD|Intradermal injection 1 x 4 administrations 4 weeks apart
16201393|NCT01383590|Biological|Cat-PAD|Intradermal injection 1 x 4 administrations 4 weeks apart.
16201394|NCT01383577|Procedure|Single hemorrhoidal ligation|Effective ligation of one hemorrhoidal group and sham ligation of the two other major hemorrhoidal groups is performed in each of three sessions of treatment. Final revision is performed 90 days after first session of hemorrhoidal ligation.
16201395|NCT01383577|Procedure|Triple hemorrhoidal ligation|The three major hemorrhoidal groups are ligated in the first session of ligation. Sham triple hemorrhoidal ligations are performed 30 and 60 days after the first session. Final revision is done 90 days after first ligation session.
16201396|NCT01383564|Procedure|CPAP group|Patients will be given a CPAP education program by our respiratory nurse supplemented by education brochure and a video. Attended overnight CPAP titration will be performed with the auto-titrating device. The CPAP level for each patient in the therapeutic CPAP arm is set at the minimum pressure needed to abolish snoring, obstructive respiratory events and airflow limitation for 95% of the night as determined by the overnight CPAP titration study. Patients in the CPAP therapy will be provided careful mask-fitting, chin strap to prevent mouth leak, regular review by our nurses, a basic CPAP device with intrinsic time clock to monitor CPAP usage and standard stroke rehabilitation programme. Patients on conservative treatment will only be offered standard treatment for asthma
16201397|NCT01383564|Procedure|non CPAP group|Patients who are randomised to non CPAP group will receive general health advice and no CPAP therapy will be arranged for them during the study period.
16201398|NCT01383551|Behavioral|"Becoming Parents intervention"|"A Becoming Parents programme consists of: (i) 3 antenatal workshops conducted over a period of 10-14 weeks in prenatal period; and (ii) support provided by trained volunteers for up to 3 months post-delivery; in addition to the usual prenatal education."
16201399|NCT01383538|Drug|FOLFIRINOX, IPI-926|"Oxaliplatin: intravenous, 50 to 85 mg/m2, over 2 hrs, once per cycle.
~Leucovorin: intravenous, 400 mg/m2, over 2 hrs, once per cycle.
~Irinotecan: intravenous, 120 to 180 mg/m2, over 90 minutes, once per cycle.
~5-FU: intravenous, 1600 to 2400mg/m2, over 46hr continuous infusion, once per cycle.
~IPI-926: oral, 130 to 160 mg/day, daily, 14 days per cycle."
16201400|NCT01383525|Device|Direct Selective Trabeculoplasty device|Patients will be treated with a Direct Selective Trabeculoplasty (DLTP) laser. Placement of the spots is on the sclera around the limbus.
16201401|NCT01383512|Device|ARMEO Spring|Use of the device 1 hour per day, 5 days per week during 4 weeks
16201667|NCT01381354|Dietary Supplement|Maltodextrin fiber supplement|One scoop daily.
16201403|NCT01383499|Drug|Tiotropium bromide|inhalation solution administered via Respimat in 3 different doses
16201404|NCT01383499|Drug|Tiotropium bromide|inhalation solution administered via Respimat in 3 different doses
16201405|NCT01383499|Drug|Tiotropium bromide|inhalation solution administered via Respimat in 3 different doses
16201406|NCT01383499|Drug|Tiotropium bromide|inhalation solution administered via Respimat in 3 different doses
16201407|NCT01383486|Drug|Naproxen sodium ER (BAYH6689)|Naproxen Sodium ER (BAYH6689): oral tablet upon incidence of pain
16201408|NCT01383486|Drug|Advil|Commercially available Advil; oral caplet upon incidence of pain
16201409|NCT01383460|Drug|Granulocyte Colony-stimulating Factor (G-CSF) and Erythropoetin (EPO)|G-CSF (in prefilled syringe) at a dose of 5 µg/kg s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses), along with Darbopoetin alpha 100 mcg/ week (in prefilled syringe) for 4 weeks (total 4 doses).
16201410|NCT01383460|Drug|Placebo|Placebo 1 (in prefilled syringe) s/c at days 1, 2, 3, 4, 5 and then every 3rd day till day 28 (total 12 doses), along with Placebo 2 every week (in prefilled syringe) for 4 weeks (total 4 doses).
16201411|NCT01383447|Drug|entinostat|Given PO
16201412|NCT01383447|Drug|imatinib mesylate|Given PO
16201413|NCT01383447|Other|laboratory biomarker analysis|Correlative studies
16201414|NCT01383447|Other|pharmacological study|Correlative studies
16201415|NCT01383447|Genetic|western blotting|Correlative studies
16201416|NCT01383447|Other|immunohistochemistry staining method|Correlative studies
16201417|NCT01383447|Other|flow cytometry|Correlative studies
16201418|NCT01383447|Genetic|polymerase chain reaction|Correlative studies
16201419|NCT01383447|Other|high performance liquid chromatography|Correlative studies
16201420|NCT01383447|Other|mass spectrometry|Correlative studies
16201421|NCT01383434|Procedure|Bone Marrow Transplant|Matched sibling, haploidentical or matched unrelated donor bone marrow transplant following chemotherapy
16201422|NCT01383408|Other|exhalation analysis of breath sample|study participants exhale 5 times into a test tube; test tube is presented to sniffer dogs for analysis
16201423|NCT01383395|Drug|simvastatin/cilostazol|
16201424|NCT01383356|Drug|Metformin Single Tablet|Metformin medium doseTablet
16201425|NCT01383356|Drug|Linagliptin/Metformin Combo|Fixed dose combination
16201426|NCT01383356|Drug|Linagliptin Single Tablet|Linagliptin Single medium dose Tablet
16201427|NCT01383343|Biological|Bevacizumab|Given IV
16201428|NCT01383343|Drug|Fluorouracil|Given IV
16201429|NCT01383343|Drug|Irinotecan Hydrochloride|Given IV
16201430|NCT01383343|Drug|Leucovorin Calcium|Given IV
16201431|NCT01383343|Drug|Sorafenib Tosylate|Given PO
16201432|NCT01383330|Drug|megace|800mg
16201433|NCT01383330|Drug|DW-ES(A)|625mg
16201434|NCT01383330|Drug|DW-ES(B)|625mg
16201435|NCT01383317|Device|Thigh Tourniquet (VBM Single Use Tourniquet Cuff Items 20-34-722SLZ-1)|Disposable sterile thigh tourniquet
16201436|NCT01383317|Device|Sham RIPC|Disposable sterile thigh tourniquet
16201437|NCT01383278|Behavioral|Computer-directed 5 A's intervention for smoking|Computer-directed 5 A's intervention for smoking
16201438|NCT01383278|Behavioral|Screening and resource provision|Screening and resource provision
16201439|NCT01383265|Procedure|Water method and chromoendoscopy|Study method will employ a 0.008% IC solution used with the water method for screening colonoscopy
16201440|NCT01383265|Procedure|Water method|Control method will use plain water with water method for screening colonoscopy
16201441|NCT01383252|Procedure|Water infusion in lieu of air insufflation|Air pump is turned off, water is infused using a peristaltic pump to aid colonoscope insertion until the cecum is reached. Air pockets and dirty water are suctioned before clean water is infused (exchange) to facilitate scope insertion.
16201442|NCT01383252|Procedure|Air method|Conventional air method with minimal insufflation of air to aid scope insertion until the cecum is reached. Water in aliquots will be used for irrigation and cleansing.
16201443|NCT01383239|Other|Immediate Postoperative Therapy|All patients will undergo a 16 week postoperative therapy program (a formal physical therapy program, a home exercise program or a combination of both). Immediate and delayed therapy are the current standard of care for postoperative physical therapy. The Immediate group will began physical therapy 3-7 days postoperatively.
16201444|NCT01383239|Other|Delayed Physical Therapy|All patients will undergo a 16 week postoperative therapy program (a formal physical therapy program, a home exercise program or a combination of both). Immediate and delayed therapy are the current standard of care for postoperative physical therapy. The delayed group will began physical therapy 6 weeks postoperatively
16201445|NCT01383226|Procedure|Thoracic endosonography|Thoracic endosonography is a minimal invasive diagnostic intervention
16201446|NCT01383213|Other|Oxygen therapy|patient in group oxygen therapy by Venturi Mask will be treated with oxygen until reaching clinical stability, or criteria of endotracheal intubation
16201447|NCT01383213|Other|Helmet CPAP|patient in group CPAP will be treated with CPAP until reaching clinical stability, or criteria of endotracheal intubation
16201448|NCT01383200|Drug|Tetracaine drop|0.5% Tetracaine Right eye / 2% Lidocaine Left eye
16201449|NCT01383200|Drug|Lidocaine gel|0.5% Tetracaine Left eye / 2% Lidocaine Right eye
16201450|NCT01383187|Procedure|DE graft and PRP concentrate|Application of DE graft together with PRP concentrate
16201451|NCT01383187|Procedure|DE graft|DE grafting presents a standard treatment method in patients with deep-burn trauma.
16201452|NCT01383174|Behavioral|Peer Support Program|"Work with a trained counselor who is a breast cancer survivor
~Meet 8 times in-person over the 8 week program with the counselor
~Counselor helps participant develop a personalized support program to help her improve her quality of life
~Receives information on breast cancer, its treatments, and stress management"
16201453|NCT01383161|Drug|Curcumin|Six Theracurmin capsules (containing 30 mg of curcumin each) per day for 18 months.
16201454|NCT01383161|Other|Placebo|Six capsules per day for 18 months.
16201491|NCT01382771|Drug|Intra-articular corticosteroid injection|Intra-articular injection of 0.5 cc triamcinolone acetonide (40 mg/cc) within each joint
16201492|NCT01382771|Drug|Intra-articular saline injection|Intra-articular injection of 0.5 cc normal saline in each joint
16201455|NCT01383148|Biological|TG4010|"TG4010 • TG4010 will be administered starting on Day 1 (D1) of Cycle 1 of chemotherapy and will be administered weekly for 6 weeks by subcutaneous (SC) injections and then once every 3 weeks until progression or discontinuation due to any reason.
~Chemotherapy (and bevacizumab if prescribed), will be given as 21-day cycles for a minimum of 4 cycles and up to 6 cycles.
~First line therapy:
~Non-squamous carcinoma: pemetrexed + cisplatin or paclitaxel + carboplatin +/- bevacizumab
~Squamous carcinoma: gemcitabine + cisplatin or paclitaxel + carboplatin
~Maintenance therapy:
~• Pemetrexed or erlotinib for eligible patients and according to labeling."
16201456|NCT01383148|Drug|placebo|"Placebo will be administered starting on D1 of Cycle 1 of chemotherapy and will be administered weekly for 6 weeks by SC injections and then once every 3 weeks until progression or discontinuation due to any reason.
~First line therapy: as in Arm 1
~Maintenance therapy: as in Arm 1"
16201457|NCT01383135|Drug|FPPRGD2|radiopharmaceutical administered for imaging, up to 14 mCi i.v.
16201458|NCT01383122|Device|Pulsed electromagnetic field device (ActiPatch TM)|Wire loop of pulsed electromagnetic field device is taped around the wound for 48 hours.
16201459|NCT01383122|Device|Inactive pulsed electromagnetic field device (ActiPatch TM)|Wire loop of pulsed electromagnetic field device is taped around the wound for 48 hours.
16201460|NCT01383109|Drug|14C-labeled Pyronaridine|Single dose of 720 mg Pyronaridine together with 14C-Pyronaridine (approx. 100 µg, 800 nCi).
16201461|NCT01383096|Drug|OZ439 mesylate 800mg Powder in Bottle for Oral Suspension|OZ439 800 mg (as free base) as powder in a bottle for reconstitution in a suspension prior to oral administration
16201462|NCT01383096|Drug|OZ439 mesylate 400mg Prototype Solution Formula 1|OZ439 400 mg (as free base) as a prototype solution formulation 1
16201463|NCT01383096|Drug|OZ439 mesylate 800mg Prototype Solution Formula 1|OZ439 800 mg (as free base) as a prototype solution formulation 1
16201464|NCT01383096|Drug|OZ439 mesylate 800mg Prototype Solution Formula 2|OZ439 800 mg (as free base) as a prototype solution formulation 2
16201465|NCT01383070|Behavioral|Lactational Counseling by Cell phone|The approach to promoting TIBF, EBF and TICF will be through cell phone counseling in addition to counseling in the hospitals during scheduled ante natal visits. Mother in the intervention group (beneficiaries) would be provided handsets and included in a subsidized calling plan.
16201466|NCT01383057|Procedure|Femtosecond Laser|Using the Femtosecond Laser to make a clear corneal incision.
16201467|NCT01383044|Procedure|EVL + carvedilol|EVL is performed for 2-3 times carvedilol 6.25mg-12.5 mg per day
16201468|NCT01383044|Drug|carvedilol|carvedilol 6.25mg-12.5 mg per day
16201469|NCT01383031|Procedure|CLC|CLC（4 ports or 3 ports）will be performed in a routine fashion by one full time faculty member with fellowship training in laparoscopy.
16201470|NCT01383031|Procedure|TU-LESSC|TU-LESSC will be performed in a routine fashion which is same to CLC by one full time faculty member with fellowship training in laparoscopy through the conventional laparoscopic instruments.
16201471|NCT01383018|Device|AMS Penile Prosthesis Devices|Non-interventional device registry. Outcomes for patients receiving marketed AMS penile prosthesis devices.
16201472|NCT01382979|Behavioral|AlcoholEdu for College|Online course for college freshmen.
16201473|NCT01382953|Device|Standard Holter/Investigational patch|The standard Holter and Investigational patch will be worn simultaneously for 24 hours. A single follow-up visit will follow in 2 days to remove both systems which will be sent away for analysis with the results of the standard system used, if pertinent, for patient management.
16201474|NCT01382940|Drug|rituximab|1000 mg in 250 mL intravenous infusion
16201475|NCT01382940|Drug|methotrexate|10 to 25 mg/week (oral or parenteral)
16201476|NCT01382940|Drug|methylprednisolone|100 mg methylprednisolone administered by slow intravenous infusion at least 30 minutes prior to the start of each study drug infusion
16201477|NCT01382940|Drug|acetaminophen|1 gram acetaminophen administered orally 30 to 60 minutes prior to the start of each study drug infusion
16201478|NCT01382940|Drug|antihistamine|50 mg diphenhydramine hydrochloride or equivalent dose of alternate antihistamine administered orally 30 to 60 minutes prior to the start of each study drug infusion
16201479|NCT01382914|Other|chlorhexidine 0.12%|twice daily, 10 ml, topical
16201480|NCT01382901|Drug|Ferric Carboxymaltose (FCM)|
16201481|NCT01382901|Drug|Placebo|
16201482|NCT01382888|Drug|Heparin 2,400 IU /ml Cutaneous Spray|Randomization will be performed 2 - 14 days post fistula creation surgery following confirmation that the fistula is patent by physical examination. Patients that are randomized to this study arm, will be asked to administer the study medication twice daily. Patients will get adequate training before first administration.
16201483|NCT01382888|Drug|Placebo Cutaneous Spray|Randomization will be performed 2 - 14 days post fistula creation surgery following confirmation that the fistula is patent by physical examination. Patients that are randomized to this study arm, will be asked to administer the study medication (placebo) twice daily. Patients will get adequate training before first administration.
16201484|NCT01382875|Other|Multi-disciplinary management program|conventional healthcare program for fragility fracture patients plus vibration treatment, exercise class and educational talk
16201485|NCT01382862|Other|Stroke Emergency Mobile Unit (STEMO)|Patients treated in the STEMO may receive a CT-scan and point-of-care laboratory work up. This depends on the results of the neurological examination including assessment of medical history and the indication for scanning by the radiologist on call. In case of no contraindications patients with acute ischemic stroke will receive intravenous tissue Plasminogen Activator (0.9 mg/kg BW) according to the routine use of tissue Plasminogen Activator in Germany within 4.5 hours of symptom onset but with no formal upper age limit. (In other words, patients older than 80 years will not be excluded.) In case of increased INR and intracerebral hemorrhage patients will receive Prothrombin Complex Concentrate (PCC). All other indications will be treated according to national guidelines or as considered appropriate by the neurologist.
16201486|NCT01382823|Procedure|Femtosecond Laser|Using the Femtosecond Laser to make a clear corneal incision.
16201487|NCT01382810|Drug|Altaire Gel forming solution|Three times a day for two months
16201488|NCT01382810|Drug|Refresh Tears|Three times a day for two months
16201489|NCT01382797|Drug|ALKS 37|Capsules for oral administration
16201490|NCT01382797|Drug|Placebo|Capsules for oral administration
16201493|NCT01382745|Drug|Nimotuzumab|200mg Nimotuzumab once a week for 12 weeks
16201494|NCT01382745|Radiation|Intensity Modulated Radiation Therapy (IMRT)|IMRT radiation therapy with doses varying from 45Gy-54Gy in 25-30 fractions
16201495|NCT01382732|Drug|Carbetocin|Protocol A (carbetocin + placebo) Carbetocin: 100ug (1mL) + Ringer's Lactate 10mL directly into the vein in no less than two minutes.
16201496|NCT01382732|Drug|Oxytocin|Oxytocin 20 U (4mL) diluted in a bag with 1000mL of Ringer's Lactate to be passed intravenously at a rate of 125mL/hr
16201497|NCT01382719|Drug|bremelanotide|"Subjects will administer drug on an as needed basis, prior to anticipated sexual activity.
~Investigational product: Bremelanotide aqueous solution for subcutaneous (SC) injection, provided as pre-filled syringes containing 0.75, 1.25, or 1.75 mg in 0.3 mL volume. Subjects will self-administer bremelanotide by SC injection into the anterior thigh or abdomen.
~Placebo: Same formulation as the investigation product but without the active ingredient, provided as pre-filled syringes containing 0.3 mL volume. Subjects will self-administer the placebo by SC injection in the same manner as the investigational product."
16201498|NCT01382706|Drug|docetaxel|Given IV
16201499|NCT01382706|Drug|lapatinib ditosylate|Given PO
16201500|NCT01382706|Other|immunohistochemistry staining method|Correlative studies
16201501|NCT01382706|Genetic|fluorescence in situ hybridization|Correlative studies
16201502|NCT01382706|Other|laboratory biomarker analysis|Correlative studies
16201503|NCT01382693|Behavioral|TimeSlips|TimeSlips is a group-based creative storytelling program for people with dementia. The intervention will be held twice a week for six weeks, in hour-long sessions.
16201504|NCT01382693|Behavioral|Standard care activity program|Standard-of-care activities for the study site's skilled-nursing dementia Special Care Units.
16201505|NCT01382680|Device|Guidewire|Use of a guidewire at ERCP for cannulating a stenosis of the biliary tract and for applying a therapeutic device (stent, dilation catheter, others)
16201506|NCT01382654|Drug|epinastine 0.1%|nasal spray 2 sprays to each nostril for a total of 3 doses
16201507|NCT01382654|Drug|epinastine 0.1% with taste masking agent|nasal spray 2 sprays to each nostril for a total for a 3 doses
16201508|NCT01382654|Drug|epinastine 0.2%|nasal spray 2 sprays to each nostril for a total of 3 doses
16201509|NCT01382654|Drug|epinastine 0.2% with taste masking agent|nasal spray 2 sprays to each nostril for a total of 3 doses
16201510|NCT01382654|Drug|azelastine 0.1%|nasal spray 2 sprays to each nostril for a total of 3 doses
16201511|NCT01382641|Device|Hoya AF-1 IOL|The patients will be assessed for three months
16201512|NCT01382641|Device|Revital vision|The patients will be assessed for three months.
16201513|NCT01382602|Biological|AMDC-USR|AMDC-USR Treatment
16201514|NCT01382602|Biological|Placebo|Placebo treatment
16201515|NCT01382589|Drug|Afamelanotide|NB-UVB phototherapy with or without subcutaneous, bioresorbable Afamelanotide 16 mg implants, contained in a poly(D,L-lactide-co-glycolide) implant core released over 7-10 days following implantation
16201516|NCT01382589|Device|NB-UVB|NB-UVB light therapy 3-times per week, for total of 72 treatments
16201517|NCT01382550|Drug|long-lasting OAT or 12-month OAT|"The antithrombotic treatment will be decided according to usual practice of enrolling Centers. The duration of the initial treatment with parenteral anticoagulation (Low Molecular Weight Heparin or Fondaparinux), the beginning of oral anticoagulation (OAT) with Vit K inhibitors and the International Normalized Ratio (PT-INR) target will be recorded.
~According to Center indications the OAT duration (6 months, 12 months or long-lasting) will be recorded and population will be stratified accordingly. The length of therapy will be counted from the date when a stable PT-INR is achieved.
~The occurrence of surgery, trauma, prolonged immobilization (>7 days), pregnancy (VTE risk periods) during the follow-up and the use of adequate anti-thrombotic prophylaxis will be recorded."
16201518|NCT01382537|Device|InterX 5000|A computer driven electrical stimulation unit that contains a cutaneous impedance sensor.
16201519|NCT01382537|Device|InterX 5000|Placebo treatment
16201520|NCT01382511|Drug|Simvastatine|80 mg
16201521|NCT01382498|Drug|Calcium dobesilate (Doxium)|500 mg, Tablet, Daily, 3 months
16201522|NCT01382498|Drug|Placebo drug|Similar to the that of the Experimental arm, Daily, Three months
16201523|NCT01382485|Other|RIA harvesting group|Subjects allocated to the RIA group will have the graft harvested in a standardized fashion using the technique described by Quintero et al. Briefly, the RIA device is a single-pass reamer that is connected to an aspirator and irrigator, allowing simultaneous reaming, irrigation, and aspiration of the contents of the femoral canal. RIA head size and tube length will be chosen based on preoperative templating of anteroposterior and lateral radiographs of the donor femur (a head size of 2mm larger than the inner cortical diameter at the isthmus of the femur will be selected). Fluoroscopic imaging will be used to confirm guidewire positioning and avoid eccentric reaming. Bone graft will be harvested from the central femoral canal and from each femoral condyle in 3 separate passes.
16201524|NCT01382485|Other|AICBG harvesting group|Iliac crest bone graft will be harvested from the anterior iliac crest through an incision beginning 2cm posterior to the anterior superior iliac spine and carried posteriorly. A window will be made in the iliac crest and a curette will subsequently be used to harvest the cancellous bone. The incision will be closed in 3 layers. The infiltration of local anaesthetic will be at the discretion of the surgeon.
16201525|NCT01382472|Drug|Rosuvastatin|40 mg per operative in PPCI, the 40 daily during hospital stay
16201526|NCT01382472|Drug|Simvastatin|No statin acutely. Simvastatin 20 mg from day 2.
16201527|NCT01382446|Drug|Chlorhexidine gluconate|0.12% Chlorhexidine Gluconate 15ml Twice Daily, administered via toothbrushing and swabbing teeth, tongue, gingiva, and oral mucosa.
16201528|NCT01382446|Other|Toothpaste|Brushing the teeth, tongue, gingiva, and oral mucosa twice daily with toothbrush and toothpaste.
16201529|NCT01382433|Procedure|Magnetoencephalograph (MEG)|Brain imaging device that records the magnetic fields in the brain.
16201530|NCT01382433|Behavioral|Cambridge Neuropsychological Test Automated Battery (CANTAB).|the CANTAB is sensitive to cognitive changes caused by a wide range of Central Nervous System disorders and medication side-effects . The CANTAB uses a computer with a touch screen, and affords a rapid and non-invasive assessment of cognitive functions.
16201531|NCT01382433|Behavioral|Experimental: Scale for the Assessment of Negative Symptoms (SANS) and the Positive and Negative Syndrome Scale (PANSS)|The SANS and PANSS scales asses the presence and severity of Positive and Negative of Schizophrenia
16201532|NCT01382420|Procedure|surgery|adrenalectomy
16201533|NCT01382407|Drug|Cetuximab|Once a week:Loading dose-400 mg/m2;subsequent-250 mg/m2 on days 8,15, 22,29,36 if administered as a single agent, or together with Irinotecan 125 mg/m2 on days 1,8,15,29 followed by administration every 42 days.
16201534|NCT01382368|Drug|Sildenafil|Acute single dose of 100 mg of sildenafil. Oral intake in tablet form.
16201535|NCT01382342|Drug|Rasagiline|1 mg daily
16201536|NCT01382342|Drug|Placebo|1 mg daily
16201537|NCT01382329|Biological|H5N1 (pre-)pandemic influenza vaccine (whole virion, Vero Cell derived, inactivated)|Intramuscular injection into the musculus deltoideus or subcutaneous injection in the upper arm
16201538|NCT01382316|Behavioral|Making Alcoholics Anonymous Easier (MAAEZ)|6-week, 90-minute, manualized, 12-step facilitation intervention consisting of 6 weekly session. First session is introduction. Four following core sessions attended in any order: sponsorship, principles not personalities, spirituality, living Sober. Last session, return to intro session as graduate.
16201539|NCT01382316|Behavioral|Usual care|Group format, six weekly education sessions about alcohol and drugs
16201540|NCT01382303|Drug|Pentoxifylline|Pentoxifylline 400mg three times a day
16201541|NCT01382303|Drug|Placebo|placebo tablet three times a day
16201542|NCT01382290|Procedure|MRI|
16201543|NCT01382277|Drug|Rosuvastatin|Rosuvastatin 20 mg per day for 76 weeks
16201544|NCT01382264|Other|Computer Assisted Decision Support|Program to provide recommendations for achieving glycemic control in poorly controlled patients with T2 diabetes.
16201545|NCT01382238|Drug|Dolutegravir 50 mg tablet|Dolutegravir is an experimental drug in the integrase inhibitor class for the treatment of HIV.
16201546|NCT01382238|Drug|Dolutegravir 50 mg oral granules|Dolutegravir is an experimental drug in the integrase inhibitor class for the treatment of HIV.
16201547|NCT01382225|Drug|Sodium Hyaluronate Ophthalmic Solution, 0.18%|
16201548|NCT01382225|Other|Vehicle|Inactive ingredients used as run-in and placebo comparator
16201549|NCT01382212|Drug|paricalcitol|Paricalcitol soft capsule. Starting dose of paricalcitol was determined by the intact parathyroid hormone (iPTH) value (iPTH/120) from prior to Day 1, rounded down to the nearest whole number, not to exceed 16 µg 3 times weekly, no more frequently than every other day. Decisions to hold, maintain, increase, or decrease a dose were based on the iPTH, phosphorus, and calcium results generated from the most recent visit and within target Kidney Dialysis Outcomes Quality Initiatives (KDOQI) levels.
16201550|NCT01382199|Drug|Lactoferrin|
16201551|NCT01382160|Biological|adalimumab|40 mg every two weeks, by subcutaneous way
16201552|NCT01382147|Drug|Ara-C, Mitoxantrone, Daunorubicin, Thioguanin|Chemotherapy
16201553|NCT01382134|Drug|Aspirin, desmopressin|Aspirin 100mg daily for 3 days Desmopressin 15 microgram subcutaneously once only
16201554|NCT01382134|Drug|Placebo, desmopressin|Placebo 1 tab daily for 3 days Desmopressin 15 microgram subcutaneously once only
16201555|NCT01382121|Behavioral|Peer Modeling|Participants watch a video of an adolescent completing the fitness test and explaining coping mechanisms to preform the test well.
16201556|NCT01382121|Behavioral|Control|watching a video unrelated to the fitness test and self-efficacy
16201557|NCT01382095|Biological|Recombinant fimbrial adhesin dscCfaE|10 ug on study days 0, 21 and 42
16201558|NCT01382095|Biological|Recombinant fimbrial adhesin dscCfaE|50 ug on study days 0, 21 and 42
16201559|NCT01382095|Biological|Recombinant fimbrial adhesin dscCfaE|250 ug on study days 0, 21 and 42
16201560|NCT01382095|Biological|Modified E. coli heat labile enterotoxin LTR192G|50 ug on study days 0, 21 and 42
16201561|NCT01382069|Drug|Dimethandrolone Undecanoate|Daily doses of 100, 200 and 400mg of dimethandrolone undecanoate
16201562|NCT01382069|Drug|Placebo|Placebo with capsules that look like the DMAU capsules but with no active ingredients
16201563|NCT01382056|Other|control foods|pulse-free control foods consumed daily, 5 days per week for 8 weeks
16201564|NCT01382056|Other|Mixed bean (higher amount)|0.6 cup of mixed beans consumed 5 days per week for 8 weeks
16201565|NCT01382056|Other|Mixed beans (lower amount)|0.3 cup of mixed beans consumed daily, 5 days per week for 5 weeks
16201566|NCT01382030|Drug|EIA chemotherapy|ifosfamide 1500 mg/m² iv days 1 - 4, etoposide 125 mg/m² iv days 1 and 4, and adriamycin 50 mg/m² iv day 1
16201567|NCT01382017|Drug|Lacosamide|Lacosamide 200 or 400 mg
16201568|NCT01382017|Drug|Placebo|Placebo
16201569|NCT01382017|Drug|Carbamazepine|Carbamazepine 600 mg
16201570|NCT01382004|Drug|Penicillin-G-benzathine|"Screening examination: Medical history (emphasis on skin lesions and bone signs) Physical examination.Blood samples for VDRL and TPHA. Clinical safety. Laboratory evaluations: haemoglobin, total WBC count, differential WBC count, platelet count, ALT, AST, urea and creatinine.
~Routine assessments: General clinical assessment and physical examination on Days 0 (treatment administered) and 14. Adverse events and concomitant medications (at baseline, Day 14 and in any unscheduled visit). Photograph documentation of skin lesions (at 14 days follow up visit). Follow-up visits performed on 3 and 6 will have a ± 14 days allowable window"
16201571|NCT01382004|Drug|Azithromycin|"Screening examination: Medical history (emphasis on skin lesions and bone signs) Physical examination.Blood samples for VDRL and TPHA. Clinical safety. Laboratory evaluations: haemoglobin, total WBC count, differential WBC count, platelet count, ALT, AST, urea and creatinine.
~Routine assessments: General clinical assessment and physical examination on Days 0 (treatment administered) and 14. Adverse events and concomitant medications (at baseline, Day 14 and in any unscheduled visit). Photograph documentation of skin lesions (at 14 days follow up visit). Follow-up visits performed on 3 and 6 will have a ± 14 days allowable window"
16201572|NCT01381991|Device|i-scan|For all the study procedures, Pentax EPKi processor and high-resolution adult video endoscopes (EG-2890i; Pentax, Japan) with push button switch from WL to i-scan were used. I-scan consist of three modes of image enhancement including SE, CE, ant TE. For SE and CE, switching among three enhancement levels (2+,3+,4+) is possible. Although SE and CE modes can allow detailed observation of subtle mucosal irregularities, noise increases as enhancement becomes more intense. In addition, TE is possible to switch p (pit pattern), v (vessel), b (Barrett), e (esophagus), g (stomach) and c (colo-rectum) mode.
16201573|NCT01381965|Procedure|Vitreous surgery for macular hole|Vitreous surgery for macular hole
16201664|NCT01381354|Dietary Supplement|Omega 3 fatty acids|4 grams daily by mouth.
16201665|NCT01381354|Dietary Supplement|Full Spectrum vitamin|Two capsules daily.
16201574|NCT01381952|Radiation|Low dose DSA (75% reduction compared to normal dose) with novel X-ray imaging technology.|Digital substraction angiography (DSA) with reduced dose settings (75% reduction expected) in combination with conventional X-ray imaging technology.
16201575|NCT01381952|Radiation|Normal dose DSA with conventional X-ray technology|Digital substraction angiography (DSA) with normal dose settings in combination with conventional X-ray imaging technology.
16201576|NCT01381926|Drug|exenatide|exenatide 5mcg sq twice daily for one month and exenatide 10mcg twice daily for month 2. The 3rd month is a washout period. Month 4 and 5 saline placebo is given as 5mcg and 10mcg respectively.
16201577|NCT01381926|Drug|Saline|Month 1 and 2 saline placebo is given as a low and high dose respectively. The 3rd month is a washout period. Month 4 exenatide 5mcg sq twice daily and for month 5 exenatide 10mcg twice daily is administered.
16201578|NCT01381900|Drug|Placebo|Form=capsule, route=oral administration. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).
16201579|NCT01381900|Drug|Canagliflozin 100mg|Type=1, unit=mg, number=100, form=capsule, route=oral use. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).
16201580|NCT01381900|Drug|Canagliflozin 300mg|Type=1, unit=mg, number=300, form=capsule, route=oral use. One capsule once daily for up to 18 weeks after completing a single-blind placebo run-in period (1 placebo capsule once daily for up to 2 weeks).
16201581|NCT01381900|Drug|Metformin|The participant's stable dose of background therapy of metformin should be continued throughout the study.
16201582|NCT01381900|Drug|Sulphonylurea|The participant's stable dose of background therapy of metformin plus sulphonylurea should be continued throughout the study.
16201583|NCT01381887|Drug|Placebo|Treatment A: Form=capsule, route=oral administration. Capsule is taken once daily on Day 1 and Day 2 in 1 of 4 treatment periods.
16201584|NCT01381887|Drug|Canagliflozin 300mg/Placebo|"Treatment B: Type=1, unit=mg, number=300, form=capsule, route=oral use. Capsule is taken once on Day 1 in 1 of 4 treatment periods.
~Form=capsule, route=oral administration. Capsule is taken once on Day 2 in 1 of 4 treatment periods."
16201585|NCT01381887|Drug|Canagliflozin 300mg/Canagliflozin 150mg|"Treatment D: Type=1, unit=mg, number=300, form=capsule, route=oral use. Capsule is taken once on Day 1 in 1 of 4 treatment periods.
~Type=1, unit=mg, number=150, form=capsule, route=oral use. Capsule is taken once on Day 2 in 1 of 4 treatment periods."
16201586|NCT01381887|Drug|Canagliflozin 300mg|Treatment C: Type=1, unit=mg, number=300, form=capsule, route=oral use. Capsule is taken once daily on Day 1 and Day 2 in 1 of 4 treatment periods.
16201587|NCT01381874|Drug|Exemestane|Abiraterone acetate, type=equal, unit=mg, number=250, form=tablet, route=oral use, 4 tablets
16201588|NCT01381874|Drug|Abiraterone acetate + Prednisone/ Prednisolone + Exemestane|Prednisone or Prednisolone, type=equal, unit=mg, number=5, form=tablet, route=oral use. All drugs are taken once daily.
16201589|NCT01381874|Drug|Abiraterone acetate + Prednisone or Prednisolone|Abiraterone acetate, type=equal, unit=mg, number=250, form=tablet, route=oral use, 4 tablets
16201590|NCT01381861|Biological|Carotuximab (TRC105)|Carotuximab (TRC105) 10 mg/kg weekly by intravenous administration on Days 1, 8, 15 and 22 of each 28-day cycle
16201591|NCT01381848|Drug|Doripenem|Type=exact number, unit=mg/kg, number=5, form=solution for injection, route=intravenous use, once on Day 1 for patients <8 weeks CA.
16201592|NCT01381848|Drug|Doripenem|Type=exact number, unit=mg/kg, number=8, form=solution for injection, route=intravenous use, once on Day 1 for patients >=8 weeks CA.
16201593|NCT01381835|Drug|TMC435|150 mg capsule once daily for 7 days
16201594|NCT01381822|Drug|TH-302|TH-302: administered by IV infusion over 30 or 60 minutes on Days 8, 15 and 22 of a 42 day cycle.
16201595|NCT01381809|Drug|Group 2: Placebo|form= solution for injection, route= subcutaneous use, weekly injections for 24 to 48 weeks
16201596|NCT01381809|Drug|Group 1: Epoetin alfa|type = range, unit= IU/Kg, number= 337.5 to 1050 IU/Kg, form= solution for injection, route= subcutaneous use, weekly injections (max 40,000 IU per week for first 8 weeks of treatment, max 80,000 IU per week later) using pre-filled 1mL 40,000 IU syringes for 24 to 48 weeks
16201597|NCT01381796|Drug|NP101|comparison of NP101 with minor patch modifications
16201598|NCT01381796|Drug|sumatriptan succinate|tablet, 100 mg
16201599|NCT01381783|Procedure|Phacoemulsification|Phacoemulsification under topical anesthesia
16201600|NCT01381770|Biological|platelet-derived repairing factors|autologous platelet lysate injection within 24 hours from lesion
16201601|NCT01381744|Biological|Flagellin/F1/V|Flagellin/F1/V recombinant fusion protein vaccine administered by the intramuscular route on Days 0 and 28 at a dose of 1, 3, 6, or 10 micrograms (mcg). It is a clear, colorless solution.
16201602|NCT01381744|Other|Placebo|Phosphate buffered saline (PBS) used as diluent and placebo.
16201603|NCT01381731|Drug|diquafosol tetrasodium ophthalmic solution 2%|opthalmic solution 2 drops in each eye QID
16201604|NCT01381731|Drug|placebo|opthalmic solution 2 drops in each eye QID
16201605|NCT01381718|Drug|modafinil|Given PO
16201606|NCT01381718|Other|placebo|Given PO
16201607|NCT01381705|Biological|rituximab|
16201608|NCT01381705|Genetic|DNA analysis|
16201609|NCT01381705|Genetic|gene expression analysis|
16201610|NCT01381705|Genetic|polymorphism analysis|
16201611|NCT01381705|Other|laboratory biomarker analysis|
16201612|NCT01381705|Other|medical chart review|
16201613|NCT01381692|Drug|Bortezomib|Given IV or SC
16201614|NCT01381692|Drug|Dexamethasone|Given PO
16201615|NCT01381692|Other|Laboratory Biomarker Analysis|Correlative studies
16201616|NCT01381692|Other|Quality-of-Life Assessment|Ancillary studies
16201617|NCT01381692|Biological|Rituximab|Given IV
16201618|NCT01381692|Drug|Temsirolimus|Given IV
16201619|NCT01381679|Drug|Ezetimibe|Ezetimibe was not mandatory and was prescribed as per routine prescription by physician.
16201620|NCT01381666|Drug|INS316 solution for inhalation|inhalation via nebulizer given for 2 doses for 60 minutes each
16201621|NCT01381666|Drug|hypertonic saline 3% sodium chloride solution|inhalation via nebulizer given for 2 doses for 60 minutes each
16201666|NCT01381354|Dietary Supplement|Essential - hydroxytyrosol|Two capsules twice daily.
16201622|NCT01381653|Other|Behavioral: HIV prevention intervention|Substance using HIV-negative young men who have sex with men who engage in sexual risk and use social networking (Facebook) will be recruited and enrolled in a brief intervention utilizing Motivational Interviewing over chat window to reduce their substance use and sexual risk. They will also evaluate their intervention experience at the end of their eight sessions and post-assessment.
16201623|NCT01381640|Drug|Marketed paracetamol|marketed formulation
16201624|NCT01381640|Drug|Experimental paracetamol formulation|Experimental formulation
16201625|NCT01381627|Drug|Remifentanil|Remifentanil IV bolus 0.5 mcg/kg bolus in 10 minutes. Initial bolus followed by infusion 0.05-0.25 mcg/kg/min for OAA/S 2-3. Remifentanil IV bolus 0.3 mcg/kg PRN for time-limited painful stimuli.
16201626|NCT01381627|Drug|Dexmedetomidine|Dexmedetomidine 0.4 mcg/kg IV bolus in 10 minutes. Dexmedetomidine 0.5-1.0 mcgg/kg/h for OAA/S 2-3. Midazolam 0.015 mg/kg bolus IV PRN.
16201627|NCT01381614|Drug|Targeted agents indicated in management of advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib)|Metastatic RCC patients on either sunitinib or sorafenib or bevacizumab or pazopanib (identified based on claims) will be evaluated for presence or absence of common severe adverse events. These common severe adverse events will be identified from agent's product labels.
16201628|NCT01381601|Drug|Targeted agents indicated in management of advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib)|Metastatic RCC patients on either sunitinib or sorafenib or bevacizumab or pazopanib (identified based on claims) will be evaluated for presence or absence of common severe adverse events. These common severe adverse events will be identified from agent's product labels.
16201629|NCT01381588|Other|Fracture evaluation|DEXA(Dual-energy X-ray absorptiometry), X-ray
16201630|NCT01381575|Biological|GSK Biologicals' HPV vaccine 580299|Subjects received 2 or 3 doses of HPV vaccine administered intramuscularly.
16201631|NCT01381562|Drug|Drug: GSK2251052|Reconstituted, added to 250mL 0.9% NaCl solution and administered via IV infusion
16201632|NCT01381562|Drug|Meropenem|Reconstituted, added to 100mL 0.9% NaCl solution and administered via IV infusion
16201633|NCT01381562|Other|Placebo|saline placebo
16201634|NCT01381549|Drug|GSK2251052|Reconstituted, added to 250mL 0.9% NaCl solution and administered via IV infusion
16201635|NCT01381549|Drug|imipenem-cilastatin|Prepare as per prescribing information instructions in 100 mL bag of 0.9% NaCl and administered via IV infusion
16201636|NCT01381549|Other|Placebo|saline placebo
16201637|NCT01381536|Drug|GSK1550188 1mg/kg or 10mg/kg|IV one shot
16201638|NCT01381523|Drug|Combination therapy with sumatriptan and naproxen sodium (SumaRT/Nap)|Patients with new pharmacy claims for SumaRT/Nap with separate analyses for patients with at least one triptan pharmacy claim in the 6-month, pre-index period and those who are triptan-naive based on 6 months of data
16201639|NCT01381523|Drug|Single-entity oral triptans|Patients are propensity score matched to patients in the SumaRT/Nap groups and analyzed separately if patient has a pharmacy claim for a different type of triptan in the previous 6 months or is triptan treatment naive. Triptans included almotriptan, naratriptan, rizatriptan, eletriptan, zolmitriptan, frovatriptan, sumatriptan.
16201640|NCT01381510|Drug|5-alpha Reductase Inhibitor (5ARI)|A 5ARI: Either dutasteride or finisteride
16201641|NCT01381497|Drug|Combination therapy of sumatriptan and naproxen sodium (SumaRT/Nap)|This is an observational study and patients were prescribed this medication before study start
16201642|NCT01381497|Drug|Triptan monotherapy|This is an observational study and patients reported a previous triptan monotherapy prescription. Drugs of interested included naratriptan, sumatriptan, rizatriptan, frovatriptan, almotriptan, eletriptan, zolmitriptan
16201643|NCT01381484|Drug|10% Argireline|10% Argireline (La jolie gel®, Pacific health care, Thailand) were instructed to apply the gel over the face and periorbital area twice daily for a period of 3 months.
16201644|NCT01381471|Drug|fluticasone propionate/salmeterol xinafoate combination|fluticasone propionate/salmeterol xinafoate combination
16201645|NCT01381458|Drug|FSC|fluticasone propionate / salmeterol xinofoate combination
16201646|NCT01381458|Drug|ACs|tiotropium alone, ipratropium alone, or in combination with albuterol
16201647|NCT01381445|Drug|GW870086 0.2%|White to slightly coloured opaque cream
16201648|NCT01381445|Drug|GW870086 2%|White to slightly coloured opaque cream
16201649|NCT01381445|Drug|Clobetasol Propionate|White cream
16201650|NCT01381445|Drug|Placebo|White to slightly coloured opaque cream
16201651|NCT01381432|Drug|Azathioprine|At the start of treatment, 2 to 3 mg per kg of body weight each day. For the rest of treatment, 1 to 2 mg per kg of body weight each day.
16201652|NCT01381419|Drug|GSK1144814|Single dose.
16201653|NCT01381419|Drug|GSK1144814|Single dose which may be split in up to three divided doses given 2 to 3 hours apart.
16201654|NCT01381419|Drug|GSK1144814|Single dose that may be split in up to three divided doses given 2 to 3 hours apart.
16201655|NCT01381406|Drug|TIO|Patients receiving tiotropium bromide at index within the study period.
16201656|NCT01381406|Drug|TIO+FSC|Patients receiving tiotropium bromide plus fluticasone propionate-salmeterol xinafoate combination at time of index within the study period.
16201657|NCT01381393|Drug|Ibandronate|Basically there is no treatment allocation. Subjects who would be administered of ibandronate at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.
16201658|NCT01381380|Procedure|Manual therapy|Manual therapy, once a week for 8 weeks
16201659|NCT01381367|Biological|PPSV23 pneumococcal vaccine (Pneumovax®)|The adult anti-pneumococcal vaccine was a 23-polyvalent pneumococcal vaccine (Pneumovax®, Aventis Pastuer MSD), 0.5 ml of which was given subcutaneously. Duration of the efficacy is about 4-5 years.
16201660|NCT01381367|Drug|Normal Saline|normal saline, 0.5ml given subcutaneously
16201661|NCT01381354|Other|Progressive exercise|Progressive strengthening exercises designed to improve core muscles and muscles of ambulation.
16201662|NCT01381354|Device|Neuromuscular electrical stimulation delivered using the electrical therapy device EMPI 300 PV|Neuromuscular electrical stimulation to train core muscles and ambulation muscles. Device is Empi 300 manufactured by DJO Inc.
16201663|NCT01381354|Other|Modified paleolithic diet|Diet based upon a Paleolithic diet and structured to increase the consumption of greens, sulfur rich vegetables, bright colors, seaweed and omega 3 fatty acid rich foods.
16201668|NCT01381354|Dietary Supplement|Mineral boost (magnesium)|Two capsules daily
16201669|NCT01381354|Dietary Supplement|Niacinamide|500 mg daily
16201670|NCT01381354|Dietary Supplement|Methyl B12|Methyl B12 1000 mcg daily
16201671|NCT01381354|Dietary Supplement|Taurine|one gram daily
16201672|NCT01381354|Dietary Supplement|creatine|one teaspoon daily
16201673|NCT01381354|Dietary Supplement|thiamine|100 mg daily
16201674|NCT01381354|Dietary Supplement|riboflavin|200 mg daily
16201675|NCT01381354|Dietary Supplement|N acetylcysteine|1 gram daily
16201676|NCT01381354|Dietary Supplement|alpha lipoic acid|300 mg twice daily
16201677|NCT01381354|Dietary Supplement|L acetyl carnitine|500 mg twice daily
16201678|NCT01381354|Dietary Supplement|methyl folate|1000 mcg one pill four times a week
16201679|NCT01381354|Dietary Supplement|coenzyme Q|100 mg daily
16201680|NCT01381354|Behavioral|meditation|meditation 15 minutes daily
16201681|NCT01381354|Behavioral|self massage|self massage of hands, feet, ears 15 minutes daily
16201682|NCT01381354|Behavioral|learning|completing puzzles or learning 15 minutes daily
16201683|NCT01381354|Dietary Supplement|Coconut oil|If excessive weight loss occurs, the subject will add 1-2 tablespoons of coconut oil daily to smoothies or foods eaten.
16201684|NCT01381341|Drug|linifanib|QD on Day 1 of Periods 1 and 2
16201685|NCT01381315|Procedure|Injection of isotope|On the day of surgery, if the radioactive SLN cannot be located using the gamma probe prior to incision, lymphazurin or methylene blue dye will be used in the breast in the subareolar plexus at the discretion of the surgeon for assistance in identifying the sentinel nodes. This contingency, expected to occur <3% of the time, will be used since locating the SLN for staging is of greater importance than the study. If radioactive isotope is sufficient to identify the sentinel node draining from the breast, then the blue dye will be injected dermally in the upper inner arm along the bicipital groove of the ipsilateral arm in order to locate the draining lymphatics from the arm. No more than 5cc of blue dye will be injected in any of the above mentioned scenarios.
16201686|NCT01381315|Procedure|Axillary lymph node dissection|The one-year lymphedema rate among subjects undergoing axillary lymph node dissection with or without sentinel lymph node biopsy is ≥ 0.13. With our sample size of 58 subjects undergoing ALND, we will reject that hypothesis in favor of the alternative-that the lymphedema rate is <0.13 for subjects undergoing ALND-if lymphedema is confirmed in three or fewer (ie, 0, 1, 2, or 3) subjects.
16201687|NCT01381289|Drug|VX-770|150 mg tablet, oral use, twice daily every 12 hours (q12h)
16201688|NCT01381276|Other|Beta-Carotene bio-fortified cassava porridge without oil|300 g of porridge (11 ounces) containing 100 g drained mashed cassava and approximately 1 mg beta-carotene.
16201689|NCT01381276|Other|Beta-Carotene bio-fortified cassava porridge with oil|300g porridge (11 ounces) containing 100 g drained mashed cassava, 15 g peanut oil, and approximately 1 mg beta-carotene.
16201690|NCT01381276|Other|White cassava porridge with retinyl palmitate reference dose|300 g porridge containing 15 mL peanut oil, 100 g drained mashed cassava, and a tracer of approximately .3 mg pure food-grade retinyl palmitate.
16201691|NCT01381263|Behavioral|Behavioural medicine treatment|The behavioural medicine treatment program will include muscle strengthening, stretching, posture training, training of relaxation techniques and information about pain according to the best empirical praxis and age appropriate interventions aimed to address the emotional and behavioural processes of pain.
16201692|NCT01381263|Other|Standard treatment|Standard treatment includes muscle strengthening, stretching, posture training, training of relaxation techniques and information about pain according to the best empirical praxis
16201693|NCT01381250|Behavioral|cognitive behavior therapy|The treatment was based on established cognitive behavior therapy methods, as described in self-help books (Hodgins, 2002; Ladouceur & Lachance, 2006). The text was divided into eight modules and was adapted for Internet use. The first four modules had a motivational interviewing focus and included building motivation for change by letting the participant answer open-ended questions that would evoke talk of change. The participants were encouraged to ask for input from their relatives on different aspects of their gambling. In addition, the first four modules included time line follow-back and mapping of the reasons for gambling. The remaining four modules were based on CBT. Each module included information and exercises and ended with three to eight essay-style questions. Feedback on homework assignments was usually given within 24 hr after participants had sent their answers via e-mail. Once weekly, a telephone call was made by the therapists to each participant.
16201694|NCT01381237|Behavioral|game-based balance exercises|16 sessions, scheduled two per week, each lasting 45 minutes.
16201695|NCT01381224|Other|Observation of biomechanical effects post injection|Observation of effects on gait, lumbar spine range of motion and pain symptoms immediately following injection and at two weeks post injection
16201696|NCT01381211|Drug|TACE-DEB|Transcatheter arterial chemoembolization (TACE) is performed with drug eluting beads (DEB), polyvinyl alcohol-based microspheres loaded with the chemotherapeutic agent doxorubicin.
16201697|NCT01381211|Drug|90Y-RE|Glass Yttrium-90 microspheres (TheraSphere®; MDS Nordion Inc.) will be used
16201698|NCT01381198|Procedure|Distal rectus femoris transfer|Transfer of the distal rectus femoris tendon to the semitendinosus tendon.
16201699|NCT01381185|Drug|Aspirin 200mg qd, Clopidogrel 2x75mg qd|According to 2 platelet monitoring assays HPR confirmation aspirin will be increased to 200mg qd, clopidogrel to 2x75mg qd. This treatment will be given for 30 days from index event (myocardial infarction)
16201700|NCT01381172|Device|Optimizer System|The OPTIMIZER System delivers non-excitatory cardiac contractility modulating (CCM) electrical signals to the heart muscle. Treatment group subjects receive five non-contiguous one-hour periods of CCM signals per day.
16201701|NCT01381172|Other|No intervention: Optimal medical therapy|The control group receives optimal medical therapy only.
16201702|NCT01381159|Behavioral|Motivational Communication|Brief MC sessions focused on medication adherence within 4-6 week period
16201703|NCT01381159|Behavioral|Control|Standard medical care
16201704|NCT01381146|Behavioral|Impact of Crime Modules|5 session/1 week modules of a restorative justice inspired victim impact group intervention
16201705|NCT01381146|Behavioral|TAU|have access to other jail programs and services
16201795|NCT01380431|Drug|Lisinopril|50% of subjects received the Par formulated product.
16202707|NCT01372787|Other|Questionnaire Administration|Ancillary studies
16201706|NCT01381133|Behavioral|Chestnut Bloomington Outpatient (CBOP)|CBOP is an evidence-informed intervention that has developed over 20 years and been shaped by treatment research. The underlying theory of change is that the combination of multiple evidence-based and best-practice treatment components will increase the adolescent's desire to change, provide the necessary skills, and create an environment supportive for this change. The intervention is based on a manual and is primarily delivered through skill and therapy groups, combined with a limited number of family and individual sessions for treatment planning and progress reviews.
16201707|NCT01381133|Behavioral|Motivational Enhancement Therapy/Cognitive Behavior Treatment (MET/CBT 7)|A manual-based 5-session MET/CBT model was supplemented with 2 family sessions. First was a family session to provide parents with an overview. Next was an individual adolescent MET session that focused on building rapport, explaining treatment, building motivation, and reviewing personalized feedback. In the third session, the therapist helped the adolescent complete a functional analysis of substance use and a personal goal worksheet. During sessions 4-6, the adolescent joined a closed group of 6 for 90-min CBT skills groups focusing on substance refusal skills, enhancing social support, planning for high-risk situations, and coping with relapse. The last session was a family session to review progress, relapse signs, and continuing care plans. Treatment lasted about 12 weeks.
16201708|NCT01381133|Behavioral|Assertive Continuing Care (ACC)|ACC is a home-based continuing care approach that takes place over a 12-14 week period and has shown promise in a randomized clinical trial of adolescents discharged from residential treatment. Following an operant reinforcement and skills training model, ACC combines the Adolescent Community Reinforcement Approach and case management services to help adolescents and their caregivers engage in prosocial activities, skills, and needed community services during weekly home visits.
16201709|NCT01381120|Drug|Solifenacin succinate treatment|Dosage form: tablet, film coated Dosage: 5 mg Frequency: daily Duration: three months
16201710|NCT01381120|Drug|Oxycodone and acetaminophen combination treatment|Dosage form: tablet, film coated Dosage: 10 mg Frequency: every 6 hours Duration: 5 - 8 days (stent inserted)
16201711|NCT01381107|Drug|ALKS 5461|Sublingual administration once daily for 7 consecutive days.
16201712|NCT01381107|Drug|Placebo|Sublingual administration once daily for 7 consecutive days.
16201713|NCT01381094|Drug|AKB-6548|oral dose administered once daily for 42 days
16201714|NCT01381094|Drug|Placebo|oral placebo administered once daily for 42 days
16201715|NCT01381081|Biological|platelet-rich plasma|a single intra-articular injection
16201716|NCT01381081|Drug|Corticosteroid|A single betamethasone and bupivacaine intra-articular injection
16201717|NCT01381068|Device|End tidal CO2 monitor|The sensor is placed in the respiratory circuit in both arms of the trial but the display is visible to the resuscitation team in the monitored arm and is covered in the control arm. The end tidal CO2 data is collected in both arms.
16201718|NCT01381055|Drug|Pentoxifylline|Patients with cutaneous leishmaniasis treated with pentavalent antimony/Meglumine antimoniate 20mg/kg/day during 20 days and pentoxifylline pills 400mg three times a day during 20 days.
16201719|NCT01381055|Drug|Placebo|Patients with cutaneous leishmaniasis treated with pentavalent antimony/metilglucamine 20mg/kg/day during 20 days and placebo pills three times a day during 20 days.
16201720|NCT01381016|Drug|Estradiol|Subjects were instructed to apply 0.1 mg/d transdermal estrogen for one month.
16201721|NCT01381016|Drug|Gonadotropin-releasing hormone (GnRH)|Pituitary response was assessed to determine how estradiol administration alters pituitary sensitivity to GnRH.
16201722|NCT01381016|Drug|Progesterone|Subjects who failed to initiate a menstrual period following 40 days on the patch were instructed to take 200 mg daily of progesterone for 10 days or as long as deemed necessary.
16201723|NCT01381003|Genetic|pCCLchimGp91s lentiviral vector transduced CD34+ cells infusion|pCCLchimGp91s lentiviral vector transduced CD34+ cells will be infused in a volume of 50-100 mls intravenously over 30-45 minutes
16201724|NCT01380990|Genetic|Infusion of autologous EFS-ADA LV CD34+ cells|Autologous EFS-ADA LV CD34+ cells (OTL-101*) are infused intravenously
16201725|NCT01380990|Other|Haematopoietic Stem Cell Transplantation (HSCT)|Historical data from a database of ADA-SCID patients treated with allogeneic HSCT from GOSH will be collected as comparator group.
16201726|NCT01380990|Drug|Busulfan|Busulfan is used for non-myeloablative conditioning
16201727|NCT01380990|Drug|Peg-Ada|Peg-Ada enzyme replacement therapy is discontinued at Day +3- (-3/+15 days) after successful engraftment
16201728|NCT01380977|Behavioral|Impact of Crime group intervention|A group intervention for 16 1.5 hr sessions held twice a week
16201729|NCT01380951|Drug|telbivudine|telbivudine 600mg/d 96 weeks
16201730|NCT01380938|Drug|Peginterferon alpha-2a + Ribavirin|"Administration of ribavirin at a dosage of 1000 or 1200 mg per day based on body weight < or > 75 kg for 24 weeks (Arm A).
~Treatment duration of 48 weeks with standard fixed dose of ribavirin (800 mg/day) (Arm B).
~These schedules will be compared with diagram of standard therapy with 800 mg daily of ribavirin for 24 weeks (Arm C)"
16201731|NCT01380912|Drug|methylprednisoloneacetate|Either methylprednisoloneacetate 80 mg or saline solution will be injected first day after operation, when the drain is removed.
16201732|NCT01380899|Procedure|Biopsy of skin|Under local anesthesia with 1% xylocaine, 4-mm punch biopsies with 3-mm depth, including the dermis and subcutaneous fat tissue, will undergone from two regions, neck and lower back.
16201733|NCT01380886|Other|experimental infant formula with alternate protein source|experimental infant formula to be fed ad libitum
16201734|NCT01380886|Other|Infant formula powder|powdered infant formula to be fed ad libitum
16201735|NCT01380873|Drug|Period I : HKB0701, Period II : HKB0701 and SLM0807, Period III : CJ30001|
16201736|NCT01380873|Drug|Period I : HKB0701 and SLM0807, Period II : CJ30001, Period III : HKB0701|
16201737|NCT01380873|Drug|Period I : CJ30001, Period II : HKB0701, Period III : HKB0701 and SLM0807|
16201738|NCT01380860|Procedure|Colostomy with mesh implantation|Colostomy with mesh implantation
16201739|NCT01380860|Procedure|Simple colostomy|Colostomy with no mesh implantation.
16201740|NCT01380847|Genetic|mRNAs encoding genes|investigate whether the levels of 21 mRNAs encoding genes involved in EMT/fibrogenesis and the alloimmune response are a sensitive and specific non-invasive diagnostic test for CAN in renal allografts
16201886|NCT01379664|Drug|Isoflurane|Isoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist
16201741|NCT01380834|Drug|control group|Group 2(control group): 42 patients will have placebo/normal saline in paravertebral space, same amount, and injection at incision sites for all four insufflation ports with ropivacaine 0.5%.
16201742|NCT01380834|Drug|treatment group|Group 1( treatment group ): 42 patients will have six paravertebral nerve blocks with ropivacaine 0.5 %, and incisional administration of placebo / normal saline at all four laparoscopic ports.
16201743|NCT01380821|Radiation|Myocardial SPECT|Myocardial SPECT according to clinical standards for patients with a clinical indication to undergo this imaging test.
16201744|NCT01380808|Drug|capecitabine and pseudomonas aeruginosa combination|capecitabine 1000mg/m2 bid, po. pseudomonas aeruginosa 0.5ml loading dose,1ml qod ih.
16201745|NCT01380795|Biological|CTC|every two cures of a standard chemotherapy patients will be taken sample of blood to monitor CTC presence and EGFR/ K-ras status of that CTC
16201746|NCT01380782|Drug|BIBF 1120|200 mg BID oral for 28 day cycle
16201747|NCT01380769|Drug|CRLX101|CRLX101 is administered at 15mg/m2 IV every other week
16201748|NCT01380769|Other|Best Supportive Care|best supportive care
16201749|NCT01380756|Drug|Arm 1- Dose Escalation|AMG 900 is a small molecule aurora kinase inhibitor. AMG 900 will be administered daily for 4 days every 2 weeks or daily 7 days every 2 weeks (ie.g., 4 consecutive days of dosing followed by 10 consecutive days off treatment).
16201750|NCT01380756|Drug|Arm 2- Dose Expansion|AMG 900 is a small molecule aurora kinases inhibitor. The dose expansion phase would be conducted to gain further clinical experience with AMG 900 in AML at the optimal dose schedule.
16201751|NCT01380743|Drug|duvoglustat|Single oral dose
16201752|NCT01380743|Drug|rhGAA|Single intravenous infusion
16201753|NCT01380730|Biological|Evolocumab|Administered by subcutaneous injection
16201754|NCT01380730|Other|Placebo to Evolocumab|Administered by subcutaneous injection
16201755|NCT01380717|Drug|Beta-blocker, ACE-inhibitor|Beta-blocker: 50- 100 mg 1-2 times a day. ACEi: 5-10 mg once a day
16201756|NCT01380717|Drug|Calcium Channel Blockers, ACE-Inhibitor|Calcium Channel Blockers: 5-10 mg a day. ACEi: 5-10 mg a day
16201757|NCT01380704|Drug|ABT-436|QD Days 1-7
16201758|NCT01380704|Drug|Matching Placebo|QD Days 1-7
16201759|NCT01380691|Drug|LY2216684|Administered orally
16201760|NCT01380691|Drug|Placebo-matching LY2216684|Administered orally
16201761|NCT01380691|Drug|Placebo-matching alcoholic beverage|Administered orally
16201762|NCT01380691|Drug|Alcoholic beverage|Administered orally
16201763|NCT01380678|Drug|Intralesional injection of bevacizumab|single dose of 2 mg of bevacizumab intralesional injection on pterygium Combination of topical antazoline and tetrahydrozoline four times a day
16201764|NCT01380678|Drug|Topical antihistamine and vasoconstrictor|combination of topical antazoline HCl 0.05% and tetrahydrozoline HCl 0.04%
16201765|NCT01380665|Device|Prevena Incisional Management System|All evaluable patients will utilize the Prevena Incisional Management System
16201766|NCT01380652|Procedure|whole body vibration training|pulmonary rehabilitation with strength and endurance training and additionally vibration training
16201767|NCT01380639|Other|whole body vibration training|performing squats for 3x3 minutes while using vibration platform three times a week
16201768|NCT01380626|Procedure|exercise training|strength and endurance training, 5 time per week.
16201769|NCT01380613|Behavioral|Workshop|10 session intervention
16201770|NCT01380613|Behavioral|Workshop control|1 session intervention on standard HIV/STD information
16201771|NCT01380600|Drug|Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)|Intravenous Dose Range: 1x10^6 pfu/kg, 1x10^7 pfu/kg, 3x10^7 pfu/kg Up to 4 intravenous infusions administered over 60 minutes every 2 weeks.
16201772|NCT01380561|Drug|asimadoline|10mg [14]C labelled asimadoline Day 1 then 7 doses 0.5 mg asimadoline bid beginning on Day 2 and ending on Day 5.
16201773|NCT01380548|Dietary Supplement|Placebo|Placebo; once/day; for 12 weeks
16201774|NCT01380548|Dietary Supplement|Iron alone|Iron (3 mg); once/day; for 12 weeks
16201775|NCT01380548|Dietary Supplement|Low-dose 5-aminolevulinic acid with iron|5-Aminolevulinic acid (12.5 mg) and iron (3 mg); once/day; for 12 weeks
16201776|NCT01380548|Dietary Supplement|Medium-dose 5-aminolevulinic acid with iron|5-Aminolevulinic acid (25 mg) and iron (3 mg); once/day; for 12 weeks
16201777|NCT01380548|Dietary Supplement|High-dose 5-aminolevulinic acid with iron|5-Aminolevulinic acid (50 mg) and iron (3 mg); once/day; for 12 weeks
16201778|NCT01380535|Drug|ECP Methoxsalen|Methoxsalen delivered by ECP
16201779|NCT01380535|Drug|Standard of Care|Tapered prednisone with cyclosporine or tacrolimus via oral administration, consistent with local institutional practice (corticosteroids and cyclosporine A/tacrolimus)
16201780|NCT01380522|Drug|Metronidazole|Capsules, single-dose, fed
16201781|NCT01380522|Drug|Flagyl|Capsules, single-dose, fed
16201782|NCT01380509|Drug|Metronidazole|Capsules, single-dose, fasting
16201783|NCT01380509|Drug|Flagyl|Capsules, single-dose, fasting
16201784|NCT01380496|Drug|doxycycline monohydrate|tablet, 100 mg, single, oral dose
16201785|NCT01380496|Drug|doxycycline monohydrate|Capsule, 100 mg, single, oral dose
16201786|NCT01380496|Drug|doxycycline monohydrate|Capsule, 100 mg, single, oral dose
16201787|NCT01380483|Drug|doxycycline monohydrate|Tablets, 100 mg, single, oral dose
16201788|NCT01380483|Drug|doxycycline monohydrate|Capsule, 100 mg, single, oral dose
16201789|NCT01380457|Drug|Dronabinol|Capsules, 10 mg, single dose, fasting conditions
16201790|NCT01380457|Drug|Marinol|Capsules, 10 mg, single-dose, fasting conditions
16201791|NCT01380444|Procedure|Gamma3 Intramedullary Nails (Stryker)|The Gamma3 nail is cannulated for Guide-Wire-controlled insertion, and features a conical tip for optimal alignment with the inner part of the cortical bone. A single distal Locking Screw is provided to stabilize the nail in the medullary canal and to help to prevent rotation in complex fractures.
16201792|NCT01380444|Procedure|Sliding Hip Screws|The sliding hip screw is a single larger diameter partially threaded screw, which is affixed to the proximal femur with a side plate (with a minimum of two holes and a maximum of four holes) and no supplemental fixation.
16201793|NCT01380431|Drug|Lisinopril|Tablets, 40 mg, single oral dose
16201794|NCT01380431|Drug|lisinopril|Tablets, 40 mg, single, oral dose
16201796|NCT01380405|Behavioral|education intervention|"Individual or collective education interventions about the correct use of inhalers.
~session in the management of inhalers in the collective or individual programmed.
~Session individual: 2 session. 15 min for session. Session collective: 2 session. 30-40 min for session. Maximum 4 persons."
16201797|NCT01380379|Behavioral|Life skills and self-defense training|8 week class which meets once per week for 2.5 hours. Each class contains the following components: 1) life skills/education training. This includes basic education about physical and sexual assaults, assault risks, dating and communication, assertiveness training and boundary setting, 2) physical self-defense training, 3) supportive therapy/debriefing.
16201798|NCT01380366|Drug|Somatropin|Patients are given somatropin (growth hormone) for their short bowel syndrome for 28 days at a dose of 0.1 mg/kg subcutaneously daily to a maximum of 8 mg daily.
16201799|NCT01380366|Procedure|Seven Day Food Diary|Subjects are asked to fill out a seven day food diary the week prior to their inpatient appointment, prior to receiving rHGH treatment for their short bowel syndrome. Subjects will be asked to repeat the use of a food diary after completing the administration of the growth hormone.
16201800|NCT01380366|Procedure|Blood Tests (standard of care)|Blood tests are taken (standard of care) to evaluate the potential hepato-protective effects of improving intestinal barrier function on those receiving human growth hormone for short bowel syndrome. Per clinical protocol to test liver function i.e. Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline phosphatase (ALP), Gamma-glutamyl transpeptidase (GGT), Total Bilirubin). A complete blood count (CBC) with platelets (PLTS) and white-count differential (WBC with diff) is performed to check for anemia and infection. These tests will be taken at baseline (before fasting) and repeated again on the 28th day (last dose) of the growth hormone. Blood is also taken at clinical visit over the next two years (approximately every two months).
16201801|NCT01380366|Other|Fasting|Eight hour overnight fast prior to being given sucralose, mannitol, lactulose, and sucrose. This is done at baseline (day one) and repeated again after the last dose of growth hormone and prior to sugar permeability urine tests.
16201802|NCT01380366|Other|Sugar Permeability Test|Subject will be given 4 capsules of sucralose (250mg per capsule), 2.0 grams of mannitol, 7.5 grams of lactulose, and 40 grams of sucrose in 150 mL of water. This will be given on the second day of the study after an 8-hour overnight fast and repeated within 72 hours of the last dose of growth hormone.
16201803|NCT01380366|Other|Urine Collection|Urine will be collected for the following five hours after subject has been given combination of sucralose, mannitol, lactulose, and sucrose to complete the intestinal sugar permeability test looking at urine ratio of lactulose to mannitol (L/M ratio). Tests include urinalysis (UA) and a blood urea nitrogen (BUN)/creatinine (Cr).
16201804|NCT01380353|Drug|Diclofenac epolamine patch|Patch (10cm X 14cm) is comprised of an adhesive material containing 1.3% diclofenac epolamine which is applied to a non-woven polyester felt backing and covered with a polypropylene film release liner [B].
16201805|NCT01380340|Other|Seniors Early Intervention Planning and Discussion.|The seniors early intervention driving group is for seniors who have been identified by professionals as having to face changes to their driving status. It involves activities such as change strategies, positive psychology approaches and topic based discussion designed to mitigate the health and quality of life effects of driving regulation and cessation.
16201806|NCT01380327|Biological|Cockroach Sublingual Immunotherapy (SLIT) - Low Dose|Participants are randomized to receive daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to three escalating doses, or until the maximum study dose (420 microliters, 1:20 w/v) was achieved.
16201807|NCT01380327|Other|Placebo|Participants are randomized to receive either daily (low dose) or twice-daily (high dose) placebo treatment placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The placebo was also administered during the preliminary dosing visits, up to three or seven escalating doses, or until the maximum study dose (420 or 840 microliters, 1:20 weight per volume [w/v]) was achieved.
16201808|NCT01380327|Biological|Cockroach Sublingual Immunotherapy (SLIT) - High Dose|Participants are randomized to receive twice-daily doses of glycerinated German cockroach (Blattella germanica) allergenic extract formulated in 50% glycerin at a concentration of 1:20 weight per volume [w/v] placed under the tongue (sublingual route) to dissolve. The treatment course and study duration was 3 months. Note: The extract was also administered during the preliminary dosing visits, up to seven escalating doses, or until the maximum study dose (840 microliters, 1:20 w/v) was achieved.
16201809|NCT01380314|Drug|Miltefosine + Imiquimod|150 mg x d during 28 days and cream applied every other day during 3 weeks
16201810|NCT01380314|Drug|Miltefosine 150 mg x day + Placebo|150 mg x d during 28 days and cream applied every other day during 3 weeks
16201811|NCT01380301|Drug|Miltefosine and antimony|Short course (half of each drug) administered simultaneously
16201812|NCT01380301|Drug|Miltefosine alone|short course (half)
16201813|NCT01380288|Drug|rivastigmine patch|rivastigmine patch 5cm2 for 4 weeks and then augmented to 10cm2 for 20 weeks
16201814|NCT01380275|Drug|Docetaxel (Taxotere)|This study : Docetaxel 100 mg/m2 mixed in D5W or N/S IV over 60 min: Day 1. Premedications : Dexamethasone 3 mg/m2 PO or IV 12 hours and 1 hour prior to docetaxel administration. A third dose of dexamethasone will be given 8 hours following docetaxel infusion. Patients should not be treated with docetaxel if they did not start the PO premedication the previous day. Parenteral pheniramine maleate may be given prior to docetaxel if patient has had a previous hypersensitivity to the agent. If used, pheniramine maleate (1 mg/kg IV) should be administered 30 minutes prior to infusion and every six hours thereafter, as needed.
16201815|NCT01380275|Drug|Irinotecan|This study : Irinotecan 80 mg/m2 mixed in D5W IV over 90 min: Days 1 and 8. Premedications : Dexamethasone 3 mg/m2 PO or IV 12 hours and 1 hour prior to docetaxel administration. A third dose of dexamethasone will be given 8 hours following docetaxel infusion. Patients should not be treated with docetaxel if they did not start the PO premedication the previous day. Parenteral pheniramine maleate may be given prior to docetaxel if patient has had a previous hypersensitivity to the agent. If used, pheniramine maleate (1 mg/kg IV) should be administered 30 minutes prior to infusion and every six hours thereafter, as needed.
16201887|NCT01379664|Drug|Sevoflurane|Sevoflurane is administered to patient during surgery as it would normally be administered by the attending anesthesiologist
16201816|NCT01380249|Drug|PDM08|To assess the tolerability and safety of increasing multiple doses administration of PDM08: 560 μg, 1.12, 2.24, 3.5, 14, 28 and 56 mg administered twice a week for four weeks in patients with advanced solid tumours for which there is no standard therapy or they are refractory to it.
16201817|NCT01380236|Drug|ASM8|
16201818|NCT01380223|Drug|placebo|I.V. infusion of placebo for 8 hr
16201819|NCT01380223|Drug|omecamtiv mecarbil|I.V. infusion of placebo for 2 hr followed by 6 hr infusion of omecamtiv mecarbil at 0.005 mg/kg/hr
16201820|NCT01380223|Drug|omecamtiv mecarbil|I.V. infusion of placebo for 2 hr followed by 6 hr infusion of omecamtiv mecarbil at 0.015 mg/kg/hr
16201821|NCT01380223|Drug|omecamtiv mecarbil|I.V. infusion of placebo for 2 hr followed by 6 hr infusion of omecamtiv mecarbil at 0.025 mg/kg/hr
16201822|NCT01380223|Drug|omecamtiv mecarbil|I.V. infusion of placebo for 2 hr followed by 6 hr infusion of omecamtiv mecarbil at 0.0625 mg/kg/hr
16201823|NCT01380223|Drug|omecamtiv mecarbil|I.V. infusion of placebo for 2 hr followed by 6 hr infusion of omecamtiv mecarbil at 0.125 mg/kg/hr
16201824|NCT01380223|Drug|omecamtiv mecarbil|I.V. infusion of placebo for 2 hr followed by 6 hr infusion of omecamtiv mecarbil at 0.25 mg/kg/hr
16201825|NCT01380223|Drug|omecamtiv mecarbil|I.V. infusion of placebo for 2 hr followed by 6 hr infusion of omecamtiv mecarbil at 0.5 mg/kg/hr
16201826|NCT01380223|Drug|omecamtiv mecarbil|I.V. infusion of placebo for 2 hr followed by 6 hr infusion of omecamtiv mecarbil at 1.0 mg/kg/hr
16201827|NCT01380223|Drug|omecamtiv mecarbil|I.V. infusion of placebo for 2 hr followed by 6 hr infusion of omecamtiv mecarbil at 0.75 mg/kg/hr (dose reduced)
16201828|NCT01380223|Drug|omecamtiv mecarbil|I.V. infusion of placebo for 2 hr followed by 6 hr infusion of omecamtiv mecarbil at 0.625 mg/kg/hr (dose reduced)
16201829|NCT01380197|Drug|Morphine|"Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.
~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
16201830|NCT01380197|Drug|Nubain|"Loading Dose: 0.1mg/kg. May repeat every 15 min up to a maximum of 3 total doses until pain controlled.
~Continuous rate: 0.01-0.04mg/kg/hr (titrated to comfort level) PCA dose 0.01-0.03 mg/kg maximum 1.6 mg/dose 4 hour dose limit 0.24-0.3 mg/kg (Maximum dosing will not exceed 25 mg/4 hrs)."
16201831|NCT01380184|Drug|ridaforolimus|4 enteric-coated tablets, each containing 10 mg ridaforolimus, orally (total daily dose: 40 mg)
16201832|NCT01380158|Device|Cup pessary (Bioteque America, Inc)|Placement of cup pessary in the vagina after randomization
16201833|NCT01380145|Biological|recMAGE-A3 Protein + AS15 Adjuvant|recMAGE-A3 + AS15 was administered intramuscularly at a dose of 300 µg recMAGE-A3, with no dose adjustments permitted. The first immunization was administered 6 to 15 week prior to auto-SCT, with subsequent immunizations administered on Days 10, 31, 52, 73, and 94 (± 3 days) and Days 180 and 270 (± 7 days) after auto-SCT.
16201834|NCT01380132|Procedure|Anal injection of Nasha Dx|Submucous injection of Nasha Dx 5-10 mm above dentate line
16201835|NCT01380119|Biological|V7|experimental arm
16201836|NCT01380119|Other|placebo|placebo pill
16201837|NCT01380106|Drug|Lenalidomide 15mg|Subjects will receive oral lenalidomide 15 mg once daily for 1-21 of a 28 day cycle.
16201838|NCT01380106|Drug|Lenalidomide 25mg|Subjects will receive oral lenalidomide 25mg once daily for days 1-21 out of a 28 cycle
16201839|NCT01380093|Drug|Placebo|Single-dose, 2 x microcrystalline cellulose (weighed to equal weights of average tablet/capsule of active comparator) mixed with 150 ml artificially sweetened, non-carbonated beverage
16201840|NCT01380093|Drug|MS Contin (morphine sulfate, controlled release)|Single-dose, 2 x 60 mg morphine sulfate whole tablets manually crushed and mixed with 150 ml artificially sweetened, non-carbonated beverage
16201841|NCT01380093|Drug|EMBEDA (morphine sulfate / naltrexone hydrochloride)|Single-dose, solution 2 x 60 mg morphine sulfate with sequestered 2.4 mg Naltrexone hydrochloride whole capsules manually crushed and mixed with 150 ml artificially sweetened, non-carbonated beverage
16201842|NCT01380080|Drug|Atripla (r)|Patients are administered one tablet of Efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg (EFV/FTC/TDF, Atripla) to taken be taken orally once daily at bedtime without food.
16201843|NCT01380080|Drug|Efavirenz|Participants will take one 600 mg tablet administered orally once daily without food.
16201844|NCT01380080|Drug|Truvada|Participants will take one tablet of Emtricitabine 200mg/tenofovir disoproxil fumarate 300mg (FTC/TDF, Truvada) administered orally once daily with or without food.
16201845|NCT01380080|Drug|Rifampin/isoniazid/pyrazinamide/ethambutol FDC|Participants will be administered Rifampin/isoniazid/pyrazinamide/ethambutol FDC tablets orally, once daily; dose by weight as determined in Table 5.1-1 of the protocol, for the first 8 weeks.
16201846|NCT01380080|Drug|Rifampin/isoniazid FDC|Participants will be administered rifampin/isoniazid FDC tablets orally, once daily; dose by weight as determined in Table 5.1-1 in the protocol, for 16 weeks following the first 8 weeks.
16201847|NCT01380080|Drug|Isoniazid|INH 300 mg orally once daily
16201848|NCT01380054|Behavioral|Evaluation of quality of life|-Psychological interviews-Questionaires : HAD, STAI, CHIP, MHLC, WCC, SSQ scales-Quality of life : SF-36
16201849|NCT01380028|Drug|oral corticosteroids|Active treatment is prednisone establishment within 72 hours after the end of surgery at the dose of 1 mg / kg (rounded to the nearest 10 mg) once daily orally for one week . The daily dose then decreases in increments of 10 mg weekly, by the second week. Once the level of 10 mg / day reached the daily dose by one level lower than 5 mg weekly. Treatment is stopped after this week to 5 mg / day (average 2 months of treatment)
16201850|NCT01380028|Drug|placebo|placebo
16201851|NCT01380015|Other|Commercially spearmint tea|Commercially available, non-selectively bred spearmint tea.
16201852|NCT01380015|Other|High Rosmarinic Acid Spearmint Tea|The investigational product will be a high rosmarinic acid spearmint tea (700B) developed by the Department of Plant Agriculture, University of Guelph. Clone 700B has been selectively bred to contain a rosmarinic acid content 15-20 times greater than that of typical mint.
16201853|NCT01379989|Drug|Carboplatin|Carboplatin AUC 5
16201854|NCT01379989|Drug|Pegylated Lipoxomal Doxorubicin (PLD)|PLD 30 mg/m² i.v.
16201855|NCT01379989|Drug|Trabectedin|trabectedin 1.1 mg/m2 3-hour i.v. infusion on Day 1 every 3 weeks. The use of central venous access is strongly recommended.
16202058|NCT01378364|Drug|Placebo|single dose of Placebo s.c.
16201856|NCT01379976|Drug|Acetylcarnitine|"ALC or placebo will be administered concurrently with CHT at 1000 mg sachet three times every day (before meals).
~Treatment should be administered for a maximum of 6 cycles for both arms unless progression or unacceptable toxicity, or treatment refusal."
16201857|NCT01379976|Drug|Placebo|"ALC or placebo will be administered concurrently with CHT at 1000 mg sachet three times every day (before meals).
~Treatment should be administered for a maximum of 6 cycles for both arms unless progression or unacceptable toxicity, or treatment refusal."
16201858|NCT01379937|Biological|Influenza vaccine GSK1562902A Formulation 1|Intramuscular injection, two doses each in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 1 - Havrix / Havrix Jr Group
16201859|NCT01379937|Biological|Influenza vaccine GSK1562902A Formulation 2|Intramuscular injection, one dose each in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and GSK1562902A Formulation 2 - Havrix / Havrix Jr Group
16201860|NCT01379937|Biological|Havrix™|Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group, GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group
16201861|NCT01379937|Biological|Havrix™ Junior|Intramuscular injection, one dose in GSK1562902A Formulation 1 and 2 - Havrix / Havrix Jr Group and two doses each in GSK1562902A Formulation 1 - Havrix / Havrix Jr Group,GSK1562902A Formulation 2 - Havrix / Havrix Jr Group and Havrix / Havrix Jr Group
16201862|NCT01379924|Behavioral|Parenting/Life Skills Intervention|Modules adapted from the Ansell-Casey Life Skills Assessment Curriculum, the Women's Negotiation Project Curriculum for Teen Mothers and the Nurturing Curriculum. Goal is to help teen mothers develop positive parenting skills, decrease repeat pregnancy and acquire skills of daily living. The series of five, one-hour long, structured, one-on-one interactive modules aims to help teens build positive, empathetic relationships with their children, while enhancing self-efficacy and increasing the sense of self- worth for parents and children. Domains addressed include child development/discipline, safety, house/money management, social relationships, career planning, substance abuse and community and interpersonal violence.
16201863|NCT01379924|Other|Teen-tot medical home|Medical, mental health, and social services provided to teen parents and their children
16201864|NCT01379911|Other|Yogurt|
16201865|NCT01379898|Drug|Phenoxybenzamine|Starting dosage of phenoxybenzamine in hypertensive subjects:20 mg q.d. (=10 mg b.i.d.) and in normotensive subjects 10 mg q.d. (in the evening). Dose escalation until blood pressure targets are reached, with a maximum dose of 140 mg q.d. (=70 mg b.i.d.)
16201866|NCT01379898|Drug|Doxazosin|Starting dosage of doxazosine in hypertensive subjects:8 mg q.d. (=4 mg b.i.d.)and in normotensive subjects starting dose 4 mg q.d. (in the evening). Dose escalation until blood pressure targets are reached, with a maximum dose of 48 mg q.d. .(=24 mg b.i.d.)
16201867|NCT01379885|Behavioral|Standard technique|Children in the ST group will receive vapocoolant spray and arm gripping adjacent to the injection site performed by MA 1(immunizer). A second MA (MA 2) will perform the visual distraction by descending contralateral arm vibration using the massage instrument (buzzer).
16201868|NCT01379885|Behavioral|Parent participation technique|The children in the PPT group will receive the same sequence, except that the parent/caregiver will administer the visual distraction rather than by MA2
16201869|NCT01379872|Other|Non-Interventional Study|This is a non-interventional study
16201870|NCT01379846|Biological|TAK-816+ DPT-TAKEDA|TAK-816 0.5 mL and DPT-TAKEDA 0.5.mL, subcutaneous injections, three doses administered at 4-week intervals over 8 weeks, followed by a fourth dose 52 weeks after third dose.
16201871|NCT01379846|Biological|ActHIB+ DPT-TAKEDA|ActHIB 0.5 mL and DPT-TAKEDA 0.5.mL, subcutaneous injections, three doses administered at 4-week intervals over 8 weeks, followed by a fourth dose 52 weeks after third dose.
16201872|NCT01379820|Device|OROTRACHEAL cpap WITH COMPENSATION BAG ( GREGORY CPAP)|USE OF OROTRACHEAL CPAP FOR RESPIRATORY DISTRESS SYNDROME IN NEWBORNS .
16201873|NCT01379807|Drug|panitumumab + docetaxel + cisplatino|Panitumumab, docetaxel and cisplatin combination treatment will be administered for 6 months or until disease progression (PD) according to investigator's criteria unacceptable toxicity or consent withdrawal.
16201874|NCT01379781|Behavioral|Behavioral Intervention for PPD|We will select a sample of pregnant women at risk for PPD, teach parenting skills to increase infant nocturnal sleep and reduce fuss/cry behavior to half of the sample during 3 perinatal visits.
16201875|NCT01379768|Device|Lotrafilcon A contact lens|Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily and extended (overnight) wear for up to 30 nights.
16201876|NCT01379768|Device|Lotrafilcon B contact lens|Commercially marketed, silicone hydrogel, single-vision contact lens FDA-approved for daily or extended (overnight) wear up to 6 nights.
16201877|NCT01379768|Device|Clear Care Cleaning and Disinfection Solution|Hydrogen peroxide-based contact lens care system for nightly cleaning and disinfection of study lenses
16201878|NCT01379742|Device|RapidStrand seeds for use with 18g needle|Rapidstrand seeds are standard size and are used with 20 g needles
16201879|NCT01379742|Device|ThinStrand|ThinStrand seeds are smaller in diameter and used with 20g needles
16201880|NCT01379729|Other|Transplantation of encapsulated beta cells.|Implantation of a therapeutical dose of encapsulated beta cells.
16201881|NCT01379729|Other|Transplantation of encapsulated beta cells.|Implantation of a therapeutical dose of encapsulated beta cells.
16201882|NCT01379716|Other|skin biopsy|Using a punch biopsy, the study doctor will take a small sample of skin (3mm diameter) from a pre-defined site of the subject. For PHN patients, 4 biopsies will be obtained: 2 in an area of PHN and 2 in a contralateral control site. Biopsy sites for each PHN control subject will be matched anatomically to the corresponding PHN patient with two biopsies each from symmetrical sites in a left and right dermatome. One biopsy from each site in each subject will be fixed in a left and right dermatome. One biopsy from each site in each subject will fixed yb immersion in 4% paraformaldehyde for immunocytochemical analysis, and the second biopsy form each site will be flash frozen for assessments of mRNA expression.
16201883|NCT01379690|Other|HBA1C|Used level of HBA1C as a reflection of glycaemic control of the cases and controls
16201884|NCT01379677|Drug|Rubidium-82|Maximum dose allowed per injection: 2200 MBq Maximum cumulated dose allowed per examination: 4400 MBq Intravenous Use
16201885|NCT01379677|Drug|Sestamibi. reconstitution with sodium pertechnetate (99mTc)|Maximum dose allowed per injection: 1000 MBq Intravenous Use
16201888|NCT01379651|Other|Specific oral tolerance induction|Specific oral tolerance induction consisted in the administration of increasing amounts of raw emulsion egg
16201889|NCT01379625|Drug|Triheptanoin|Triglyceride with three heptanoin or 7 carbon fatty acids esterified to a glycerol backbone
16201890|NCT01379612|Other|Ultrasonic Elastography|Non-invasive
16201891|NCT01379599|Behavioral|brief motivation intervention|Brief motivation intervention consisting of brief psychosocial counseling (20 minutes at the time of an ER visit)
16201892|NCT01379586|Drug|ONO-4053|Part A: ONO-4053 doses proposed are 1 mg, 3 mg, 10 mg, 30 mg, 100 mg, 300 mg, 600 mg as a single dose administered by mouth once daily
16201893|NCT01379586|Drug|Placebo|Placebo to match ONO-4053 tablets dosed in a similar manner to ONO-4053
16201894|NCT01379573|Drug|Hydroxychloroquine|Nineteen women meeting eligibility criteria will receive 400mg per day of HCQ beginning as soon as pregnancy is established and informed consent obtained. Mothers already on HCQ will remain on 400mg, or escalate to 400mg if on 200mg. Hydroxychloroquine is taken in 200mg pill form - 400mg = 2 200mg pills.
16201895|NCT01379560|Drug|unoprostone isopropyl|"unoprostone isopropyl (2 drops)
~placebo (2 drops)"
16201896|NCT01379560|Drug|unoprostone isopropyl|"unoprostone isopropyl (3 drops)
~placebo (3 drops)"
16201897|NCT01379547|Behavioral|Procalcitonin guided antibiotics treatment algorithm|Patients who will be randomized to arm 2 will receive antibiotics therapy with a duration based on procalcitonin measurement on day 5, 7 and 9.
16201898|NCT01379547|Behavioral|Conventional treatment|Patients who will be randomized to arm 1 will receive antibiotic therapy with a duration based on conventional practice.
16201899|NCT01379534|Drug|TKI258|
16201900|NCT01379521|Drug|everolimus|
16201901|NCT01379521|Drug|everolimus placebo|
16201902|NCT01379508|Drug|telbivudine|600 mg film-coated tablets taken as 600 mg once daily
16201903|NCT01379508|Drug|tenofovir disoproxil fumarate|300 mg tablets taken as 300 mg once daily
16201904|NCT01379495|Behavioral|educational program+telephone follow up|burns victims will participate in an educative program including telephone follow-up during six months after hospital discharge
16201905|NCT01379482|Drug|Multimodal treatment|"3 months (range 2-4.5) with neoadjuvant systemic chemotherapy. Four weeks after receiving the last course of chemotherapy, patients will undergo laparotomy with the objective of performing cytoreduction + hyperthermic intraperitoneal chemotherapy.
~Early peritoneal chemotherapy though intrabdominal drains for the first five postoperative days.
~Neo-adjuvant chemotherapy:
~Irinotecan+Nordic FLv (6 pat.) EOX (6 pat.) FLOX (3 pat.) Docetaxel+Irinotecan+5-FU+LV (1 pat.) FOLFIRI (1 pat.) ECF (1 pat.)
~Hyperthermic intraoperative chemotherapy:
~Cisplatin+doxorubicin (5 pat.). Oxaliplatin +concomitant i.v. 5-FU+ i.v. LV (3 pat.)
~Early postoperative chemotherapy:
~5-FU + i.v. LV (5 pat.) Paclitaxel (1 pat.)"
16201906|NCT01379469|Drug|Drug-Carbamazepine (Tegretol XR)|To reduce the likelihood of hypersensitivity reactions the subjects will be started on 400 mg/day in 2 doses and the dose will be increased weekly by 200mg/day until reaching a stable therapeutic concentration with a dose not exceeding 1200mg/day(or 1000mg/day in subjects less than 15 years of age). The CBZ tablets will be encapsulated..
16201907|NCT01379469|Drug|Carbamazepine (Tegretol XR) Placebo|Carbamazepine (Tegretol XR)Placebo-the subjects will be started on 400mg/day in 2 doses and the dose will be increased weekly by 200 mg/day until reaching a dose not exceeding 1200 mg/day (or 1000 mg/day in subjects less than 15 years of age). The placebo group will receive encapsulated tables without Carbamazepine.
16201908|NCT01379456|Procedure|physiotherapy|exercises, 20 sessions over 10 weeks
16201909|NCT01379443|Other|CTN model of care for children and their families|Parental reports on the quality of life of their children and service needs
16201910|NCT01379430|Biological|AdCh63 ME-TRAP followed by MVA ME-TRAP|AdCh63 ME-TRAP 1x10^10 vp intramuscularly, MVA ME-TRAP 2x10^8 pfu intramuscularly
16201911|NCT01379430|Biological|AdCh63 ME-TRAP followed by MVA ME-TRAP|AdCh63 ME-TRAP 5x10^10 vp intramuscularly, MVA ME-TRAP 2x10^8 pfu intradermal
16201912|NCT01379417|Dietary Supplement|Probiotic supplementation|1 capsule per day, from inclusion to 4 or 6 weeks after inclusion
16201913|NCT01379404|Device|Bioelectric Impedance Analysis|Bioimpedance devices are compact, portable, easy to use, relatively inexpensive and can be used to make repeated non-invasive measurements. Bioimpedance measures the impedance to the flow of an electric current through body fluids and consists of two components, resistance and reactance. Resistance is a measure of electrical current a substance will oppose and is inversely related to tissue fluid content. Reactance is the capacitative component of impedance and indicates energy stored by cell membranes and organelles; due to this property, reactance is associated with tissue cell mass. These raw measures provide a measure of volume as determined by vector length and the RXc graph method.
16201914|NCT01379391|Drug|Recombinant Human Thrombopoietin (rHTPO)|"Patients received allogeneic myeloablative hematopoietic stem cell transplantation with platelet count lower than 20G/L on +14 days after Allo-HSCT, met the above enrollment criteria and signed the informed consent forms are eligible subjects.
~Administration method of rHuTPO: 300U/kg/d by percutaneous injection; Timing: d14 to d28 after Allo-HSCT."
16201915|NCT01379378|Device|Artificial urinary sphincter|Standard of care
16201916|NCT01379378|Device|InVance Sling|Standard of care
16201917|NCT01379378|Device|AdVance Sling|Standard of care
16201918|NCT01379378|Device|Virtue Sling|Standard of care
16201919|NCT01379378|Drug|Contigen|2.5-10 cc
16201920|NCT01379365|Device|Cryo-Touch III|Percutaneous treatment with the device
16201921|NCT01379339|Drug|Cabazitaxel 10mg/m2|"Cabazitaxel on D1 Dose: 10mg/m2 IV x 1 Route: Intravenous infusion over 60 minutes, mixed as described in protocol over 1 hour Schedule: Day 1, every 21 days (+ 2 days)
~Cisplatin on D1 Dose: 100 mg/m2 Route: Intravenous infusion over 60 minutes to 3 hours, mixed in 1000 ml of normal saline Schedule: Day 1, every 21 days (+ 2 days)
~5 Fluorouracil on D1-D4 Dose: 800 mg/m2/day Route: 24-hour continuous infusion over 4 days Schedule: Days 1, 2, 3 and 4 of Cycles 1, 2 and 3 (every 21 days) + 2 days)"
16201922|NCT01379339|Drug|Cabazitaxel 12.5mg/m2|"Cabazitaxel on D1 Dose: 12.5mg/m2 IV x 1 Route: Intravenous infusion over 60 minutes, mixed as described in protocol over 1 hour Schedule: Day 1, every 21 days (+ 2 days)
~Cisplatin on D1 Dose: 100 mg/m2 Route: Intravenous infusion over 60 minutes to 3 hours, mixed in 1000 ml of normal saline Schedule: Day 1, every 21 days (+ 2 days)
~5 Fluorouracil on D1-D4 Dose: 800 mg/m2/day Route: 24-hour continuous infusion over 4 days Schedule: Days 1, 2, 3 and 4 of Cycles 1, 2 and 3 (every 21 days) + 2 days)"
16201923|NCT01379339|Drug|Cabazitaxel 15mg/m2|"Cabazitaxel on D1 Dose: 15mg/m2 IV x 1 Route: Intravenous infusion over 60 minutes, mixed as described in protocol over 1 hour Schedule: Day 1, every 21 days (+ 2 days)
~Cisplatin on D1 Dose: 100 mg/m2 Route: Intravenous infusion over 60 minutes to 3 hours, mixed in 1000 ml of normal saline Schedule: Day 1, every 21 days (+ 2 days)
~5 Fluorouracil on D1-D4 Dose: 800 mg/m2/day Route: 24-hour continuous infusion over 4 days Schedule: Days 1, 2, 3 and 4 of Cycles 1, 2 and 3 (every 21 days) + 2 days)"
16201924|NCT01379339|Drug|Cabazitaxel 17.5mg/m2|"Cabazitaxel on D1 Dose: 17.5mg/m2 IV x 1 Route: Intravenous infusion over 60 minutes, mixed as described in protocol over 1 hour Schedule: Day 1, every 21 days (+ 2 days)
~Cisplatin on D1 Dose: 100 mg/m2 Route: Intravenous infusion over 60 minutes to 3 hours, mixed in 1000 ml of normal saline Schedule: Day 1, every 21 days (+ 2 days)
~5 Fluorouracil on D1-D4 Dose: 800 mg/m2/day Route: 24-hour continuous infusion over 4 days Schedule: Days 1, 2, 3 and 4 of Cycles 1, 2 and 3 (every 21 days) + 2 days)"
16201925|NCT01379339|Drug|Cabazitaxel 20mg/m2|"Cabazitaxel on D1 Dose: 20mg/m2 IV x 1 Route: Intravenous infusion over 60 minutes, mixed as described in protocol over 1 hour Schedule: Day 1, every 21 days (+ 2 days)
~Cisplatin on D1 Dose: 100 mg/m2 Route: Intravenous infusion over 60 minutes to 3 hours, mixed in 1000 ml of normal saline Schedule: Day 1, every 21 days (+ 2 days)
~5 Fluorouracil on D1-D4 Dose: 800 mg/m2/day Route: 24-hour continuous infusion over 4 days Schedule: Days 1, 2, 3 and 4 of Cycles 1, 2 and 3 (every 21 days) + 2 days)"
16201926|NCT01379326|Drug|Mebendazole|All children providing stool samples will be treated with mebendazole single table of 500mg under supervision (chewing + water).
16201927|NCT01379313|Procedure|conventional I:E ratio|conventional I:E ratio of 1:2 is applied.
16201928|NCT01379313|Procedure|1:1 ratio|I:E ratio of 1:1 is applied.
16201929|NCT01379313|Procedure|2:1 group|Inverse I:E ratio of 2:1 is applied.
16201930|NCT01379313|Procedure|external PEEP|external positive end-expiratory pressure of 5 cmH2O is applied.
16201931|NCT01379300|Drug|dabigatran etexilate|dabigatran etexilate, orally, as 2 x 75-mg capsules (150 mg), single administration
16201932|NCT01379300|Drug|rivaroxaban|rivaroxaban, orally, as 2 x 10-mg tablets (20 mg), single administration
16201933|NCT01379287|Drug|Iso-Fludelone|Iso-fludelone will be administered IV over 6 hours (+/- 30 mins) on Day 1 of every 3 week cycle.
16201934|NCT01379274|Drug|Lenalidomide and azacitidine combination|"lenalidomide 10 mg will be administered orally on Days 1-28 of each 28-day cycle. Patients who fail to achieve an erythroid response per 2006 IWG criteria after 3 cycles of monotherapy will receive lenalidomide at the same dose administered in cycle 3 and low-dose azacitidine25 mg/m2 subcutaneously (SC) or intravenously (IV) for 5 days (on Days 1-5) of every 28-day cycle.
~Patients who fail to respond (2006 IWG criteria) after receiving two cycles of combination therapy will receive lenalidomide at the same dose administered in Cycle 3 and azacitidine 50 mg/m2 SC or IV given daily on Days 1-5 of each 28-day cycle, if no grade 4 toxicity developed or no delay greater than 2 weeks in starting a new cycle was experienced during the first 2 cycles of combination therapy."
16201935|NCT01379261|Procedure|Cooling|1-2 liters of cold saline and central venous catheter cooling with Philips InnerCool RTx Endovascular System prior to PCI
16201936|NCT01379248|Device|manual thrombus aspiration (Export catheter, Medtronic Inc. Minneapolis, Minnesota, USA)|manual thrombus aspiration catheter to be used during percutaneous coronary intervention
16201937|NCT01379235|Other|Pilatis exercise|12 weeks of pilatis exercise 3 times a week.
16201939|NCT01379209|Drug|RGI-2001|A single administration of RGI-2001 on Day 0 post AHSCT.
16201940|NCT01379209|Drug|Calcineurin Inhibitors|GVHD prophylaxis according to institutional guidelines. Subjects could have received any number/combinations of treatments.
16201941|NCT01379209|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|According to institutional guidelines.
16201942|NCT01379209|Drug|Conditioning Regimen|Myeloablative preparative treatment according to institutional guidelines. Subjects could have received any number/combinations of treatments.
16201943|NCT01379209|Procedure|Allogeneic Bone Marrow Transplantation|According to institutional guidelines
16201944|NCT01379209|Drug|Methotrexate|
16201945|NCT01379209|Drug|Mofetil Mycophenolate|
16201946|NCT01379209|Drug|sirolimus|Administered for GVHD prophylaxis as per institutional guidelines
16201947|NCT01379196|Drug|Azithromycin|Tab. Azithromycin 500 mg PO three times weekly for 3 months
16201948|NCT01379183|Drug|Erythromycin|200 mg suspension
16201949|NCT01379183|Drug|Placebo|200 mg suspension
16201950|NCT01379183|Procedure|Magnetic Resonance Imaging|An MR enterography procedure uses magnetic resonance imaging (MRI) technology to obtain detailed images of the small bowel.
16201951|NCT01379183|Other|Barium Sulfate Solution|Participants will be given a low concentration of barium sulfate solution (1350 mL) prior to the MRI procedure. Barium sulfate is a radiopaque agent. Radiopaque agents are used to help diagnose certain medical problems. Since radiopaque agents are opaque to (block) x-rays, the areas of the body in which they are localized will appear white on the x-ray film. This creates the needed distinction, or contrast, between one organ and other tissues. The contrast will help the doctor see any special conditions that may exist in that organ or part of the body.
16201952|NCT01379170|Drug|Euthyrox (levothyroxine)|A dose of 25 μg per day of Euthyrox® will be administered orally during the first week and will be increased to 50 μg per day during the second week and to 75-100 μg per day in the third week depending on TSH, free T4 and T3 concentrations monitored throughout the treatment period. Patients will be instructed to take Euthyrox® after an overnight fast, 30 min before breakfast in the morning daily. After 3 months, free T4 and total T3 concentration must be in the normal range (free T4: 8.0-26 pmol/l, T4: 60-140 nmol/l and T3 1.2 - 3.4 nmol/l) and TSH 0.4-2.5 mU/l.
16201953|NCT01379157|Drug|Imipenem|Each patient will receive a loading dose of 0.5 g 3 min infusion followed by 0.5 hr infusion of 0.5 g every 6 hr of imipenem at room temperature
16201954|NCT01379157|Drug|Imipenem|Each patient will receive a loading dose of 0.5 g 3 min infusion followed by 4 hr infusion of 1 g every 8 hr of imipenem at room temperature
16202059|NCT01378364|Drug|Placebo|single dose of Placebo s.c.
16201955|NCT01379144|Drug|latanoprost 75 ug|"Eligible patients were randomized to receive 1 of 4 different doses of latanoprost (50, 75, 100 or 125 ug/mL).
~Study medication was supplied in clear bottles. Patients were instructed to instill one drop of study medication in one or both eyes (as instructed by their investigator) once daily in the evening between 7 PM and 9 PM during the entire treatment period. The first dose of study medication was instilled in the evening of the baseline visit and the last dose was instilled in the evening before the Week 4 (Day 28) visit."
16201956|NCT01379144|Drug|latanoprost 100 ug|"Eligible patients were randomized to receive 1 of 4 different doses of latanoprost (50, 75, 100 or 125 ug/mL).
~Study medication was supplied in clear bottles. Patients were instructed to instill one drop of study medication in one or both eyes (as instructed by their investigator) once daily in the evening between 7 PM and 9 PM during the entire treatment period. The first dose of study medication was instilled in the evening of the baseline visit and the last dose was instilled in the evening before the Week 4 (Day 28) visit."
16201957|NCT01379144|Drug|latanoprost 125 ug|"Eligible patients were randomized to receive 1 of 4 different doses of latanoprost (50, 75, 100 or 125 ug/mL).
~Study medication was supplied in clear bottles. Patients were instructed to instill one drop of study medication in one or both eyes (as instructed by their investigator) once daily in the evening between 7 PM and 9 PM during the entire treatment period. The first dose of study medication was instilled in the evening of the baseline visit and the last dose was instilled in the evening before the Week 4 (Day 28) visit."
16201958|NCT01379144|Drug|latanoprost 50 ug|"Eligible patients were randomized to receive 1 of 4 different doses of latanoprost (50, 75, 100 or 125 ug/mL).
~Study medication was supplied in clear bottles. Patients were instructed to instill one drop of study medication in one or both eyes (as instructed by their investigator) once daily in the evening between 7 PM and 9 PM during the entire treatment period. The first dose of study medication was instilled in the evening of the baseline visit and the last dose was instilled in the evening before the Week 4 (Day 28) visit."
16201959|NCT01379105|Other|neural mobilization|In the neural mobilization group, the subject was positioned in dorsal decubitus, and the researcher performed hip flexion with the knee extended passively and performed 30 oscillations of plantar-to-dorsal flexion for one minute
16201960|NCT01379105|Other|Static Stretching|In the static stretching group, the subject was positioned in dorsal decubitus, and the researcher performed hip flexion with the knee extended passively and held for 30 seconds; this type of stretching corresponds to the maintenance of increased amplitude posture, without surpassing the maximum movement limit, three times with an interval of 10 seconds between the repetitions.
16201961|NCT01379092|Device|Trident Specimen Radiography System|MIBB images will be acquired on the standard of care device and the Trident System in the Breast Center at Hoag Hospital. BSS images will be acquired on standard of care device in the Operating Room and/or the Breast Center at Hoag Hospital and then on the Trident System. Image quality will be compared and system operation will be evaluated. Feedback will be provided to manufacturer and the Trident System further refined.
16201962|NCT01379092|Device|Bioptics, Faxitron, and Full Field Digital Mammography (FFDM) Selenia|All the above devices are used for SOC BSS imaging at Hoag Hospital. The images captured from these devices will be compared to the images captured from the Trident Specimen Radiography device.
16201963|NCT01379079|Drug|Acetylsalicylic acid|aspirin intake at bedtime
16201964|NCT01379079|Drug|Acetylsalicylic acid lysinate|aspirin intake on awakening
16201965|NCT01379040|Other|Cystic Fibrosis patients|
16201966|NCT01379027|Behavioral|Pure self-help Internet CBT for depression|Internet, CBT, Depression
16201967|NCT01379027|Behavioral|Guided self-help Internet CBT|CBT, Depression, Website intervention, coaching
16201968|NCT01379027|Behavioral|Stepped-Care Internet CBT condition|Depression CBT, Internet intervention
16201969|NCT01379014|Behavioral|Decision Aid Tool|A booklet which outlines to pros and cons of different decision outcomes, and is designed to assist the user in making a decision according to their own specific circumstances
16201970|NCT01379014|Other|Treatment as Usual|The control group does not receive a copy of the decision aid tool booklet, instead received treatment as usual from vocational specialist
16201971|NCT01379001|Drug|Scopolamine|Scopolamine 0.4mg IM x 1 dose; adjustment in older group for weight (0.4mg/70kg)
16201972|NCT01379001|Drug|Placebo|IM or PO placebo
16201973|NCT01379001|Drug|Donepezil|donepezil 5mg PO x 1
16201974|NCT01378988|Drug|Dexmedetomidine|For sedation according to protocol
16201975|NCT01378975|Drug|Vemurafenib|960 mg oral doses twice daily until disease progression, unacceptable toxicity or consent withdrawal.
16201976|NCT01378962|Drug|erlotinib|150 mg orally once a day for 12 months
16201977|NCT01378949|Drug|Bupivacaine|Bupivacaine 0.5% with adrenaline 5 mcg/cc
16201978|NCT01378949|Drug|Morphine|Morphine 1 mg/cc
16201979|NCT01378936|Behavioral|MI plus IOC group intervention|45 minute Motivational Interview plus 16 session IOC intervention
16201980|NCT01378936|Behavioral|Motivational Interview only|45 minute Motivational Interview session
16201981|NCT01378923|Behavioral|REVAMP|The Re-entry values and mindfulness program (REVAMP) is an 8 session group intervention designed for jail inmates nearing release into the community
16201982|NCT01378923|Behavioral|TAU|have access to standard jail programs and services
16201983|NCT01378910|Drug|Unique|Change of PI, NNRTI or integrase inhibitor to CCR5 antagonist (maraviroc)
16201984|NCT01378897|Device|MedSignals®pillbox,Omron pedometer,VitalSignals®weight scale|Participants will use three home monitoring devices (i.e., weight scale, pedometer, pillbox) for two months. In addition, participants will receive weekly phone calls from the study's bariatric dietician during weeks 1-4 of the study and then receive biweekly calls during the second month. The structured phone calls (approximately 10-15 minutes each call) will focus on discussing the patient's adherence data, discussing any barriers to adherence, and providing tailored patient education.
16201985|NCT01378884|Drug|Domperidone|Patient to receive treatment with Domperidone
16201986|NCT01378871|Drug|IMTOX-25|This agent is supplied as a sterile solution at 0.5 mg/ml. Thus a vial with 5 mls contains 2.5 mg IMTOX-25 15 mg/m²/cycle IV; The calculated total dose for the cycle will be divided by four and given on Days 1, 3, 5 and 7.
16201987|NCT01378871|Other|IMTOX-25|Imtox-25 is an immunotoxin. It is an antibody that is bound to a piece of the poison ricin. This antibody have been shown to bind to leukemia cells and kill them because of the ricin.
16201988|NCT01378858|Drug|Varenicline|Varenicline, titrated to 1 mg twice daily, will be given to participants in both study arms for 12 weeks.
16201989|NCT01378845|Drug|Tracleer|14 days 62,5 mg Bosentan p.o 140 days 125 mg Bosentan p.o
16201990|NCT01378845|Drug|Prostavasin|Prostavasin 60 µg i.v, 5 days per week for 2 weeks
16201991|NCT01378832|Procedure|Intra-peritoneal antibiotic lavage|The lavage was performed immediately prior to closure of the abdominal wall. Prior to the lavage, a microbiological sample from the peritoneal surface (parietal and visceral) was obtained with a swab (sample 1), followed by a lavage with 500 ml normal saline, similar to the one performed in Group 1. After this lavage, a new microbiological sample was obtained from the peritoneal surface (sample 2), and a second lavage with an antibiotic solution, including gentamicin (240 mg) and clindamycin (600 mg) dissolved in 500 ml normal saline was performed. During this lavage, the solution was allowed to sit in the abdominal cavity for 3 minutes. After aspirating the lavage, a third microbiological sample was obtained in the same way as the two previous ones (sample 3).
16201992|NCT01378819|Procedure|3-midline-ports laparoscopic cholecystectomy|The laparoscopic cholecystectomy will be performed through 3 ports placed in the line alba.
16201993|NCT01378819|Procedure|3-midline-ports laparoscopic cholecystectomy|Laparoscopic cholecystectomy will be performed through 3 ports placed in the line alba.
16201994|NCT01378806|Behavioral|Nutrition and exercise education and coping skills training|A 12-week intensive intervention on nutrition and exercise education and coping skills (Phase I), 9 months of continued monthly contact (Phase II), and then 6 months on their own.
16201995|NCT01378793|Behavioral|Relaxation Acupressure|Apply pressure (stimulate) to the 9 acupoints for 3 minutes per point giving a total treatment time of 27 minutes done once daily for a period of 6 weeks.
16201996|NCT01378793|Behavioral|Stimulating Acupressure|Apply pressure (stimulate) to the 10 excitatory acupoints for 3 minutes per point giving a total treatment time of 30 minutes done once daily for a period of 6 weeks.
16201997|NCT01378780|Behavioral|Educational intervention for diet and physical activity|The proposed project, SHARE, is a culturally-tailored, primary stroke prevention intervention for MAs and EAs that targets a number of health-related behaviors related to stroke risk. Using a combination of self-help materials, social support, peer counseling based on Motivational interviewing, tailored newsletters, and social environmental changes in Catholic Churches, the SHARE intervention will lead to increases in moderate and vigorous intensity physical activity, decreases in salt intake, and increases in fruit and vegetable intake. Additional targets include decreases in BMI for those overweight or obese, reduction of dietary fat (trans, saturated and total fat), and increases in low-fat dairy products, changes that will serve to reduce blood pressure and stroke risk. Additionally, SHARE will seek to improve hypertension medication adherence in participants with previously diagnosed high blood pressure at baseline screening.
16201998|NCT01378780|Behavioral|Educational message on skin cancer awareness|Control group will get the diet and physical activity intervention after the crossover but no outcomes will be measured after the crossover
16201999|NCT01378767|Dietary Supplement|Krill oil supplementation|During a 21-day Daniel Fast, group one supplemented with krill oil capsules (two grams per day) while group two supplemented with a placebo (coconut oil capsules at two grams per day).
16202000|NCT01378754|Drug|Fospropofol (Lusedra®) 6.5|Group 1 will receive 6.5 milligram per kilogram of Fospropofol (Lusedra®) injection (IV).
16202001|NCT01378754|Drug|Fospropofol (Lusedra®) 10|Group 2 will receive 10 milligram per kilogram of Fospropofol (Lusedra®) injection (IV).
16202002|NCT01378754|Drug|Fospropofol (Lusedra®) 12|Group 3 will receive 12 milligram per kilogram of Fospropofol (Lusedra®) injection (IV).
16202003|NCT01378741|Drug|Propofol|Upon arrival to ICU patients will receive a propofol 2-6mg/kg infusion until tracheal extubation
16202004|NCT01378741|Drug|Dexmedetomidine|Upon arrival to ICU patients will receive dexmedetomidine bolus of 0.4mcg/kg followed by an infusion of 0.2-0.7mcg/kg per hour for a maximum period of 24 hours.
16202005|NCT01378715|Drug|Rosuvastatin|Patients with coronary artery disease referred for coronary angiography and subsequently PCI will be enrolled and randomized to pre-treatment with rosuvastatin (20mg 12 hours prior + 20mg immediately prior PCI).
16202006|NCT01378702|Drug|mistletoe preparations|1 ampoule (1ml) twice per week subcutaneously
16202007|NCT01378689|Other|Storytelling online video|patients with a history of chronic glucocorticoids use tell their experiences of side effects resulting from chronic use and provide advice on ways to prevent side effects
16202008|NCT01378676|Drug|Placebo (Part A)|Placebo tablets once daily for 14 days (Part A)
16202009|NCT01378676|Drug|CK-2017357 (Part A)|One 125 mg CK-2017357 tablet once daily for 14 days (Part A)
16202010|NCT01378676|Drug|CK-2017357 (Part A)|Two 125 mg CK-2017357 tablets once daily for 14 days (Part A)
16202011|NCT01378676|Drug|CK-2017357 (Part A)|Three 125 mg CK-2017357 tablets once daily for 14 days (Part A)
16202012|NCT01378676|Drug|Riluzole 50 MG (Part B)|One 50 mg tablet once daily for 14 days (Part B)
16202013|NCT01378676|Drug|Placebo (Part B)|Placebo tablets once daily for 14 days (Part B)
16202014|NCT01378676|Drug|CK-2017357 (Part B)|One 125 mg tablet once daily for 14 days (Part B)
16202015|NCT01378676|Drug|CK-2017357 (Part B)|Two 125 mg tablets once daily for 14 days (Part B)
16202016|NCT01378676|Drug|CK-2017357 (Part B)|Three 125 mg tablets once daily for 14 days (Part B)
16202017|NCT01378650|Drug|Cilostazol|Administration of Cilostazol 100mg twice a day for 4 weeks
16202018|NCT01378650|Drug|Placebo|placebo one tablet matching for cilostazol twice a day for 4 weeks.
16202019|NCT01378637|Device|AMES- Leg treatment|30 minutes of treatment of the leg consisting of the AMES device passively moving the ankle between plantarflexion and dorsiflexion with vibration of the tendons being stretched, while the participant tries to assist in the movement as much as possible.
16202020|NCT01378624|Other|Bronchoscopy|"In brief, during the first bronchoscopy a baseline BAL and baseline endobronchial brush and forceps biopsies will be obtained and allergen as well as saline (control segment) will be instilled.
~The subjects will undergo a second bronchoscopy in order to obtain BAL from the allergen challenged segments and the saline challenged segment, and endobronchial forceps biopsies."
16202021|NCT01378611|Device|Vagus Nerve Stimulator: Neurocybernetic prothesis NCP, Cyberonics Inc., Webster, TX, USA|The study group is stimulated with the following parameters: Output current 0.25 milliampere (to be ramped up to max. 1.75 milliampere), Pulse width 0.5 milliseconds, Frequency 30 Hz, Duty cycle: 30 sec on 5 min off (duty cycle 10%).
16202022|NCT01378598|Other|Nursing Educational Intervention|Four educational sessions with the direct care nurse (DCN)
16202023|NCT01378585|Drug|DLBS1033|3 x 490 mg DLBS1033 daily
16202024|NCT01378585|Drug|Placebo|3 x 1 tablet daily
16202025|NCT01378559|Other|Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) Questionnaire|A questionnaire accessing satisfaction with a penis prosthesis
16202026|NCT01378546|Drug|3,4-diaminopyridine|Treatment will begin with 5mg three times a day or less.
16202027|NCT01378533|Drug|epirubicin, cyclophosphamide, paclitaxel, carboplatin, G-CSF|epirubicin 80mg/m2 iv d1 or divide in two days cyclophosphamide 600mg/m2 iv d1 G-CSF 3ug/kg ih d5-9 q14d*4cycles paclitaxel 175mg/m2 iv d1 G-CSF 3ug/kg ih d5-9 q14d*4cycles paclitaxel 150mg/m2 iv d1 carboplatin AUC=3 iv d2 G-CSF 3ug/kg ih d5-9 q14d*8cycles
16202028|NCT01378520|Drug|ketoconazole|600 mg capsule oral once
16202029|NCT01378520|Drug|inert powder|oral once
16202030|NCT01378507|Behavioral|endoscopic submucosal dissection|ESD was carried out by using a single-channel upper gastrointestinal endoscope with a water-jet system (Q260J; Olympus Optical Co, Tokyo, Japan) and a high-frequency generator with an automatically controlled system (ENDOCUT mode) (Erbotom ICC 200; ERBE Elektromedizin GmbH, Tübingen, Germany). The transparent attachment was fitted on the tip of the endoscope mainly to obtain a constant endoscopic view and to create tension on the connective tissue for the submucosal dissection.
16202031|NCT01378481|Drug|Vorinostat|Given PO
16202032|NCT01378481|Radiation|Stereotactic Radiosurgery|Undergo fractionated stereotactic radiation therapy
16202033|NCT01378481|Other|Laboratory Biomarker Analysis|Correlative studies
16202034|NCT01378481|Other|Pharmacological Study|Correlative studies
16202035|NCT01378481|Procedure|Therapeutic Conventional Surgery|Undergo neurosurgery
16202036|NCT01378468|Other|"oral triglyceride tolerance test (not a therapeutic intervention as such but a new diagnostic test)"|see Ebinger et al., IJS, 2010
16202037|NCT01378455|Other|interactive computerized handwriting training program|In ICHTP group, they received the training of visual-perception .visual-motor integration skill of children and modulate muscle strength of grasp through ICHTP software. The training program costs 45 min/once, three times/one week, and sustains four weeks.In traditional group, they received the training of paper-pencil activities with visual-perception and visual-motor integration skills. The training duration is as long as ICHTP group.
16202038|NCT01378455|Other|traditional handwriting training program|The THTP group ,they received the training of paper-pencil activities with visual-perception and visual-motor integration skills
16202039|NCT01378442|Other|fitness training program|"Experimental: high level training group. The experimental group received training for 40 min per day 3 times a week for 12 weeks. The hVCT program consisted of a 5-min warm-up exercise, twenty repetitions of sitting-to-standing movements, cycling for 20 min, and a cool-down exercise for 5 min.
~Experimental: low level training group. The experimental group received training for 40 min per day 1-2 times a week for 12 weeks. The program consisted of a 5-min warm-up exercise, twenty repetitions of sitting-to-standing movements, fitness training for 20 min, and a cool-down exercise for 5 min.
~Control:The control group will not receive fitness training program but maintain the usual life style."
16202040|NCT01378429|Drug|ciclesonide nasal aerosol|ciclesonide nasal aerosol (74 mcg)
16202041|NCT01378429|Drug|Placebo|Placebo
16202042|NCT01378416|Drug|Decitabine (Dacogen)|Intravenous injection; total dose-per-cycle was 135 mg/m^2 of decitabine.
16202043|NCT01378390|Drug|Expanded autologous adipose-derived adult stem cells (eASCs)|Administration will be preceded by localization and closure of the internal opening. Cell treatment injection will be performed following Major Ambulatory Surgery standards. Patients will receive an intralesional dose of 20 million cells at baseline. 50% of the cell suspension will be placed into the fistula walls of the internal opening, with the remaining 50% being injected across the wall tracts of the target fistula. Patients without healing (complete fistula closure) at week 12 will receive a second dose of 40 million cells, using the same treatment approach.
16202044|NCT01378390|Drug|Placebo|Administration will be preceded by localization and closure of the internal opening following Major Ambulatory Surgery standards. Subjects will be receiving one treatment cycle with placebo consisting of intralesional instillation of 5 ml saline solution. Patients without healing (complete fistula closure) following week 12 assessment will continue to receive standard of care until the primary assessment of fistula closure at week 24. Patients with incomplete fistula closure at week 24 will be offered the possibility of participating in a separate open-label, single arm study using the ASCs derived from the liposuction procedure.
16202045|NCT01378377|Drug|Pimasertib|Pimasertib will be administered in fasted state at a dose of 45 mg once daily orally on Days 1 to 15. Treatment will be continued until disease progression, intolerable toxicity, investigator's decision to discontinue treatment, or withdrawal of consent.
16202046|NCT01378377|Drug|Pimasertib|Pimasertib will be administered in fasted state at a dose of 75 mg once daily orally on Days 1 to 15. Treatment will be continued until disease progression, intolerable toxicity, investigator's decision to discontinue treatment, or withdrawal of consent.
16202047|NCT01378377|Drug|Temsirolimus|Temsirolimus will be administered at a dose of 12.5 mg as intravenous infusion over a 30-60 minute period once a week within 10 minutes after administration of pimasertib on Days 1, 8 and 15 in successive 21-day cycles. Treatment will be continued until disease progression, intolerable toxicity, investigator's decision to discontinue treatment, or withdrawal of consent.
16202048|NCT01378377|Drug|Temsirolimus|Temsirolimus will be administered at a dose of 25 mg as intravenous infusion over a 30-60 minute period once a week within 10 minutes after administration of pimasertib on Days 1, 8 and 15 in successive 21-day cycles. Treatment will be continued until disease progression, intolerable toxicity, investigator's decision to discontinue treatment, or withdrawal of consent.
16202049|NCT01378364|Drug|AbGn-168H|single very low dose of AbGn-168H i.v.
16202050|NCT01378364|Drug|AbGn-168H|single low dose of AbGn-168H i.v.
16202051|NCT01378364|Drug|Placebo|single dose of Placebo i.v.
16202052|NCT01378364|Drug|Placebo|single dose of Placebo i.v.
16202053|NCT01378364|Drug|Placebo|single dose of Placebo i.v.
16202054|NCT01378364|Drug|Placebo|single dose of Placebo i.v.
16202055|NCT01378364|Drug|AbGn-168H|single medium dose of AbGn-168H i.v.
16202056|NCT01378364|Drug|AbGn-168H|single high dose of AbGn-168H i.v.
16202057|NCT01378364|Drug|AbGn-168H|single low dose of AbGn-168H s.c.
16202061|NCT01378351|Other|Questionnaire survey|Mailed questionnaire investigating response to empiric treatment trials, further investigations by otolarygology and possible alternative diagnoses.
16202062|NCT01378325|Drug|Phenylephrine|Prophylactic variable rate of phenylephrine infusion started at 0.75 µg/kg/min vs saline
16202063|NCT01378325|Drug|saline|Prophylactic variable rate of saline infusion where we adjusted the pump at a starting rate of 0.75 µg/kg/min, equivalent to 0.0075 mL/kg/min of saline
16202064|NCT01378312|Biological|AERAS 402|0.5 mL IM injection of 3 x 1010vp AERAS-402 on Study Days 0 and 28
16202065|NCT01378312|Biological|Placebo|0.5 mL IM injection of 0vp (Placebo) on Study Days 0 and 28
16202066|NCT01378299|Drug|Testosterone Cypionate|"Testosterone cypionate was administered at 200 mg by intramuscular injection every 2 weeks.
~DEPo-Testosterone Injection, for intramuscular injection, contains testosterone cypionate which is the oil-soluble 17 (beta)-cyclopentylpropionate ester of the androgenic hormone testosterone.
~Testosterone cypionate is a white or creamy white crystalline powder, odorless or nearly so and stable in air. It is insoluble in water, freely soluble in alcohol, chloroform, dioxane, ether, and soluble in vegetable oils. The chemical name for testosterone cypionate is androst-4-en-3-one,17-(3-cyclopentyl-1oxopropoxy)-, (178)-. Its molecular formula is CvH400a, and the molecular weight of 412.61."
16202067|NCT01378286|Drug|ARTESUNATE + AMODIAQUINE|"Pharmaceutical form:
~Route of administration:"
16202068|NCT01378286|Drug|Chloroquine|Pharmaceutical form:tablet Route of administration: oral
16202069|NCT01378273|Drug|Epo|Enrollment will occur within 24 hours of birth. Study drug will be administered intravenously for the first 6 doses. Subjects in the Epo arm will then receive 400 U/kg/dose three times a week until they reach 32-6/7 weeks postmenstrual age. Control infants will receive sham injections.
16202070|NCT01378273|Other|Control|Subjects will receive 6 doses of vehicle intravenously during the first 2 weeks of life. Doses will be administered at 48 hour intervals from the time of enrollment. Following high dose administration, sham subcutaneous injections will be given three times a week through to 32-6/7 weeks postmenstrual age.
16202071|NCT01378247|Behavioral|Family Focused Nursing|All patients receive treatment as usual. Additionally, patients in the intervention arm receives family focused nursing consultations which are structured as outpatient sessions focusing on change, improvement and/or maintenance of family function within cognitive, affective and behavioral knowledge. Each session is organized and individualized according to the wishes and needs for education and counseling of the families within a period of six months.
16202072|NCT01378234|Behavioral|Enhanced Discharge Planning Program transitional care|"Enhanced Discharge Planning Program (EDPP) provides telephonic short-term post-discharge social work services that assess and intervene from a biopsychosocial perspective for at-risk older adults returning home after an inpatient hospitalization. EDPP follows a four-step process to with three guiding tasks to reach the goal of preventing avoidable adverse events post-discharge:
~Ensure patients understand the discharge plan of care and receive recommended services while screening for unidentified medical or social needs
~Connect patients to outpatient health services (ex: home health, in-home services, dialysis, radiology, laboratory services, specialty care) with particular emphasis on the first physician follow-up appointment
~Supporting caregivers to reduce stress and burden"
16202073|NCT01378208|Behavioral|Intermittent fasting - the effect on glucose metabolism, body composition and cognitive function|"Each of the 10 subjects must through a period of monitoring (four weeks) before the study period (four weeks). Before, during, and after both the monitoring period and the study period, the subjects will undergo tests at Rigshospitalet.
~DAY 1: Inclusion and exclusion of subjects DAY 1 to DAY 28: Monitoring period (usual lifestyle)
~28 days of dietary monitoring
~28 days measurement by pedometer DAY 1, DAY 28 & DAY 56: Test 1
~Oral glucose tolerance test with stable isotopes
~Fat and muscle biopsies DAY 2, DAY 29 & DAY 57: Test 2
~DXA scanning
~Resting Metabolic Rate Measurement
~VO2max test on bicycle
~Cognitive testing
~MRI of the brain and abdomen DAY 9, DAY 19, DAY 38 & DAY 48: Test 3
~Actiheart for 3 days
~72-hour blood glucose monitoring with CGMS System DAY 29 to DAY 57: INTERVENTION
~Fasting from 7am - 9pm
~28 days of dietary monitoring
~28 days measurement by pedometer"
16202074|NCT01378195|Behavioral|CBT-based program for dementia caregivers|Participants will receive a CBT-based program [Cognitive Behavioral Therapy], containing videos, workbook, and website.
16202075|NCT01378195|Behavioral|Educational/Resources program|Participants will receive a traditional educational/resources program, containing videos, workbook, and website.
16202076|NCT01378182|Genetic|allogeneic mesenchymal stem cell transplantation|1.000.000(one million) cells/kg, IV (1/2 of dose in the Peripheral vein and 1/2 of dose into the right hepatic artery)
16202077|NCT01378156|Biological|JS7 plasmid DNA and MVA62B vaccine|JS7 plasmid DNA (3 mg at weeks 1 and 9) and MVA62B vaccine (10(8) TCID(50) at weeks 17 and 25)
16202078|NCT01378143|Drug|OCZ103-OS [pentamidine bis(2-hydroxyethanesulfonate)], mFOLFOX6 or FOLFIRI|OCZ103-OS is given in combination with Chemotherapy each cycle
16202079|NCT01378117|Drug|Sitagliptin|Sitagliptin 50-100mg po once daily
16202080|NCT01378117|Drug|glargine|glargine once daily
16202081|NCT01378117|Drug|lispro|lispro before meals
16202082|NCT01378104|Drug|peginterferon alfa 2a (pegasys)|dosage form; 180ug/week during first 12 weeks and then 135 ug/week during 36 weeks otherwise unremarkable
16202083|NCT01378104|Drug|peginterferon alfa-2a (pegasys)|These patients would be treated with standard dose 180ug /week for 48 weeks. In general, the patient with CHC genotype 1is guided with treatment with pegasys 180ug /week and ribavirin 1000-1200 mg/day for 48 weeks. We do not make intervention of ribavirin dose.
16202084|NCT01378091|Drug|Lenalidomide|"Supplied as 5 mg and 25 mg capsules.
~The lenalidomide dose levels to be studied include 10, 15, 20, 25, 30, 35 and 40 mg/day."
16202085|NCT01378091|Drug|Docetaxel|"Docetaxel is an anti-cancer (antineoplastic or cytotoxic) chemotherapy drug.
~Doses of docetaxel to be studied include 60 and 75 mg/m2 once every three weeks."
16202086|NCT01378091|Drug|Prednisone|"Prednisone is a synthetic corticosteroid drug that is particularly effective as an immunosuppressant drug.
~5 mg BID daily."
16202087|NCT01378078|Device|eldith DC-stimulator (neuroconn, Ilmenau, Germany)|daily tDCS treatment over left DLPFC, 20 min, 2 mA
16202088|NCT01378078|Device|eldith DC-stimulator (Neuroconn, Ilmenau, Germany)|same as sham stimulation
16202089|NCT01378065|Device|Restorelle Direct Fix A&P|Restorelle Direct Fix A&P is a permanently implantable synthetic mesh for reconstruction of the pelvic floor secondary to the prolapse or protrusion of the pelvic organs into or out of the vaginal canal.
16202090|NCT01378039|Drug|comparison of treatment effect on different markers|inhaled budesonide (400 µg BD) or placebo BD
16202091|NCT01377987|Drug|Acetazolamide|4 mg/kg, once daily before bed, for 7 days
16202092|NCT01377987|Drug|Placebo|4 mg/kg, once daily before bed, for 7 days
16202093|NCT01377974|Drug|Miltefosine|1 Capsule of 50mg, taken orally 2 times a day for 28 days
16202094|NCT01377974|Drug|Standard Treatment Meglumine antimoniate|20mgKg daily intravenous Meglumine antimoniate as oriented by the Brazilian Ministry of Health
16202095|NCT01377961|Drug|Randomized pills either containing combination of lycopene and isoflavones (dietary supplements) or Placebo to be taken for 12 weeks|"After the screening and OGTT, the treatment group each subject will be in is decided by randomization. Neither subject nor the researchers will be allowed to choose which group a subject is assigned to. A single patient/subject cannot be assigned more than 1 allocation number. Each subject will be assigned randomly (like drawing straws) to receive either on the pills containing the combination of 6mg lycopene and 50mg isoflavones or placebo. Each subject has a 1 in 2 chance of receiving one of these treatments.
~The subject are advised to take one capsule of Laflavon/Placebo by mouth daily for 12 weeks."
16202096|NCT01377961|Other|Screening|Volunteer will be screened as an out patient with a history, physical examination, baseline fasting plasma glucose or A1C, creatinine, AST/ALT, TSH. We may utilize the lab results of the subject available upto 3months prior to the consent date. Pregnancy tests will be performed for female candidates. Information of the level of physical activity, diet, supplements and medications will be obtained.
16202097|NCT01377961|Other|OGTT|OGTT will be done after the screening at Baseline and at the completion of the 12 weeks of taking the supplements by the subject.
16202098|NCT01377961|Other|Anthropometrics and Blood pressure|Measurements of height, weight, hip, waist and Blood Pressure are done before and after 12 weeks of taking the supplements.
16202099|NCT01377961|Other|Screening|Volunteer will be screened as an out patient with a history, physical examination, baseline fasting plasma glucose or A1C, creatinine, AST/ALT, TSH. We may utilize the lab results of the subject available upto 3months prior to the consent date. Pregnancy tests will be performed for female candidates. Information of the level of physical activity, diet, supplements and medications will be obtained.
16202100|NCT01377961|Other|Blood Drawing|The blood will be drawn at the baseline and at the completion of the 12 weeks of taking the capsules of laflavon /placebo.
16202101|NCT01377948|Behavioral|ACT with RAGE-Control|This is an open trial of ACT with RAGE-Control which is a behavioral intervention. The therapy involves five psychotherapy sessions taking place over five consecutive days.
16202102|NCT01377922|Drug|Amifampridine Phosphate|Amifampridine, 30-80 mg given 3-4 times per day with a maximum single dose of 20 mg (2 x 10 mg tablets), for 2 weeks.
16202103|NCT01377922|Drug|Placebo|Matching placebo tablets administered 3-4 times a day (to the individual patient's tablet count of active at baseline) over 2 weeks.
16202104|NCT01377909|Drug|statin|daily statin orally for 48 weeks
16202105|NCT01377883|Other|standard|"Preparation and information regarding the BTX procedure: placing EMG electrodes, wiping the area with an alcohol swab, cooling with ethyl chloride, needle insertion into the muscle and the importance of EMG noise.
~Injection performed under EMG guidance. Two sites of injection per muscle were used to enhance diffusion. The child could often see the procedure when the upper limb was treated but not during lower limb injections.
~Memory change and positive reinforcement: Following the BTX injection, the medical staff present spoke to the child positively and offered prizes Volunteer attendance: In the daycare unit there are young volunteers routinely present, assisting with technical aspects of the procedure."
16202106|NCT01377883|Behavioral|clown care|Cognitive coping Imagery Empowerment Reflecting emotions
16202107|NCT01377870|Biological|intravenous injection of mesenchymal stem cells|15 patients with relapsing remitting multiple sclerosis underwent intravenous injection of mesenchymal stem cell
16202108|NCT01377870|Biological|injection of cell free media|Patients who are in control group underwent media injection but after 6 months they will be transplanted by stem cell.
16202109|NCT01377857|Behavioral|Monetary Incentive|$1, $5, or $10 incentive
16202110|NCT01377857|Behavioral|Questionnaire Timing|Timing of the questionnaire--either before or after testing is offered.
16202111|NCT01377857|Behavioral|HIV Test Offering|HIV Test will be offered as opt-in, opt-out, or active choice.
16202112|NCT01377844|Drug|EGT0001442|
16202113|NCT01377844|Drug|Placebo|
16202114|NCT01377818|Procedure|ventilation|"positive-pressure breathing bilevel (BiPAP ® Respironics, Inc.) Parameters initially programmed be: IPAP 10 cm H2O, EPAP 4 cmH2O, method ST setting yourself respirations 12 breaths minute. The IPAP was progressively increased to a maximum of 20 cm H2O, depending on patient tolerability, clinical response and arterial oxygen saturation was continuously monitored by pulse oximetry, trying to avoid possible leaks through the mask. It can also supply oxygen through a cannula connected to the mask at a flow rate of 2-4 liters per minute to maintain oxygen saturation at around 85-90%.
~Patients aired uninterruptedly during nighttime (minimal between 6-8 hours night)."
16202115|NCT01377818|Procedure|excecise training|"The training program (trained group) was carried out for 12 weeks and sessions of 40 minutes duration:
~20 minutes of bicycle ergometer with an initial charge of about 70% of initial maximal oxygen consumption, increasing the load every two weeks as tolerated.
~Weightlifting in 2 sets of 6 replicates of 5 simple exercises. These are held at a station multigimnástica (CLASSIC Fitness Center, KETTLER)"
16202116|NCT01377818|Procedure|Both|both types of intervention
16202117|NCT01377792|Drug|Hypertonic saline|comparison of different dosages of drug
16202118|NCT01377779|Drug|Oxiplex/AP gel|Intrauterine application of Intercoat following hysteroscopy
16202119|NCT01377779|Drug|Normal Saline|No intrauterine application of Intercoat following hysteroscopy
16202120|NCT01377753|Device|Visualase Thermal Therapy System|Used for performing Laser Induced Thermal Therapy to destroy malignant or unwanted tissue by delivering laser energy sufficient to cause coagulation and necrosis of the tissue.
16202121|NCT01377740|Device|The Zeltiq System|Non-invasive cooling is applied to the treatment area with a defined cooling rate and duration.
16202122|NCT01377675|Other|Education|The third year internal medicine residents completed the usual curriculum for COPD and took one pretest and two posttests to validate the questions.
16202123|NCT01377662|Drug|OND-PR002 and MPh-IR|"Drug: OND-PR002
~Single daily oral doses of 8 mg Ond-PR002
~Drug: MPh-IR
~Single daily oral doses of 20 mg MPh-IR"
16202124|NCT01377662|Other|Placebo: Two dextrose capsules for Ond-PR002 and MPh-IR|Single daily oral doses
16202125|NCT01377636|Drug|Isoproterenol|patients will receive isoproterenol, have a BIS monitoring device and a modified isolated forearm test (no neuromuscular blockade).
16202126|NCT01377623|Drug|Dexmedetomidine group|Subjects undergoing one or two level spinal fusion surgery will be screened for eligibility to participate in the study. Subject will be screened, recruited and randomized during the preadmission visit or the day of surgery. Eligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).
16202127|NCT01377623|Drug|Placebo group|Fifty six subjects (28 in each arm) will be enrolled. Subjects undergoing one or two level spinal fusion surgery will be screened for eligibility to participate in the study. Subject will be screened, recruited and randomized during the preadmission visit or the day of surgery. Eligible subjects will be randomized to one of the two treatment group in1:1 ratio to receive either DEX or matching placebo (PBO, LR).
16202128|NCT01377610|Drug|oral naltrexone|Following detoxification with buprenorphine (one dy of 8 mg) followed by oral naltrexone (ascending taper to 25 mg), participants will receive Vivitrol injection on Day 8. Behavioral therapy sessions will be offered for five weeks.
16202129|NCT01377610|Drug|Buprenorphine|Following detoxification with buprenorphine [8-mg buprenorphine (Day 1) tapering to 0 mg (Day 7)] participants will receive Vivitrol injection on Day 15. Behavioral therapy sessions will be offered for five weeks.
16202130|NCT01377610|Drug|Vivitrol|dose of long-acting injectable naltrexone (Vivitrol 380 mg i.m. Injection)
16202131|NCT01377597|Drug|ranibizumab|
16202132|NCT01377584|Behavioral|Couple-oriented intervention|The first session will occur before the patient receives his/her CPAP and will last approximately 2 hours. This session will provide the couple with education on sleep apnea and CPAP and information on different types of PAP therapy and cleaning procedures, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP and will last approximately one and a half hours. The second session will provide the couple with information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The individual telephone follow-up sessions will occur two weeks after the patient has received his/her CPAP and will last approximately 20 minutes. This session will review CPAP usage and explore barriers and facilitators of CPAP use.
16202133|NCT01377584|Behavioral|Patient-oriented intervention|The first session will occur before the patient receives his/her CPAP and will last approximately one and a half hours. This session will provide the patient with education on sleep apnea and CPAP and information on different types of PAP therapy and cleaning procedures, explore patient's concerns about starting CPAP treatment, and provide a goal setting exercise. The second face to face session will occur one week after the patient receives his/her CPAP and will last approximately 45 minutes. The second session will provide information on CPAP usage and pre- and post-treatment AHI, explore barriers to CPAP use and benefits of CPAP use, and provide a goal setting exercise. The telephone follow-up session will occur two weeks after the patient has received his/her CPAP and will last approximately 20 minutes. This session will review CPAP usage and explore barriers and facilitators of CPAP use.
16202134|NCT01377584|Device|Continuous positive airway pressure (CPAP)|CPAP is treatment for obstructive sleep apnea. CPAP therapy keeps the airway open during the night by providing a stream of air through a mask that is worn while sleeping.
16202135|NCT01377584|Other|No intervention|No intervention will be received.
16202136|NCT01377571|Biological|Rotarix|2 doses of Rotarix vaccine, 106.5CID/dose, 1-month interval between doses
16202137|NCT01377558|Other|Aerobic endurance training intervention|"The aerobic endurance training group will use cardiovascular training devices
~week 1-4: 15 minutes warm up (group) 15 minutes intervention at 80-100% vAT two times per week
~week 5-13: 15 minutes warm up (group) 30 minutes intervention at 95-110% vAT two times per week
~week 14-26: 15 minutes warm up (group) 45 minutes intervention at 95-110% vAT two times per week"
16202138|NCT01377558|Other|Strength endurance training intervention|"The strength endurance training intervention group will perform eight exercises on weight machines (Milon circuit training- 60 seconds activity, 30 seconds break)
~week 1-4: 15 minutes warm up (group) 1 session resistance training intensity 3 (Buskies) two times per week
~week 5-13: 15 minutes warm up (group) 2 sessions resistance training intensity 5 (Buskies) two times per week
~week 14-26: 15 minutes warm up (group) 3 sessions resistance training intensity 5 (Buskies) two times per week"
16202139|NCT01377558|Other|Combined aerobic endurance and strength endurance training|"week 1-4: 15 minutes warm up (group) 15 minutes intervention at 80-100% vAT once per week and 15 minutes warm up (group) 1 session resistance training intensity 3 (Buskies) once per week
~week 5-13: 15 minutes warm up (group) 15 minutes intervention at 95-110% vAT and 1 session resistance training intensity 5 (Buskies) two times per week
~week 14-26: 15 minutes warm up (group) 30 minutes intervention at 95-110% vAT and 1 session resistance training intensity 5 (Buskies) once a week and 15 minutes warm up (group) 15 minutes intervention at 95-110% vAT and 2 sessions resistance training intensity 5 (Buskies) once a week"
16202140|NCT01377545|Procedure|Local Anesthetic given via perineural catheter for infraclavicular nerve block.|Patients will be randomized to receive 30mL of Lidocaine via Catheter for an infraclavicular nerve block on one side (right or left) and via needle on the other side. Sensory and strength will be tested following local anesthetic administration.
16202141|NCT01377545|Procedure|Local Anesthetic given via needle for infraclavicular nerve block|Patients will be randomized to receive 30mL of Lidocaine via Catheter for an infraclavicular nerve block on one side (right or left) and via needle on the other side. Sensory and strength will be tested following local anesthetic administration.
16202181|NCT01377207|Procedure|Primary PCI|Thrombus aspiration and hystopathological analysis, Optical Coherence Tomography assessment of STEMI culprit vessel, Primary PCI with Drug Eluting Stent implantation; Repeat OCT assessment of culprit vessel at 9 monts follow-up
16202182|NCT01377194|Drug|Levomilnacipran ER|Drug: Levomilnacipran ER 40mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks
16202183|NCT01377194|Drug|Levomilnacipran ER|Drug: Levomilnacipran ER 80mg/day Study drug is to be given orally, in capsule form, once daily, for 8 weeks
16202184|NCT01377194|Drug|Placebo|Matching placebo to be given orally, in capsule form, once daily, for 8 weeks.
16202185|NCT01377168|Drug|oral naltrexone|
16202186|NCT01377168|Drug|Placebo pill|
16202142|NCT01377532|Drug|131 I-Metaiodobenzylguanidine (131 I-MIBG)|Therapeutic 131I-MIBG will be synthesized at Nuclear Diagnostic Products (NDP; Rockaway, New Jersey) with specific activities of 9-18 Ci/mmole. The therapeutic dose: 8-12 mCi/kg (maximum 500 mCi ± 10% at investigator's discretion) will be diluted in 25 ml of normal saline, and will be infused intravenously through a patient's peripheral or central line over 120 minutes. The patient will remain in a radiation protected isolation room until radiation emissions are ≤ 2 mr/hr at a 1 meter distance or meets institutional and state guidelines. This usually takes 4-6 days. In all cases, special shielding will be equipped in the room to minimize exposure to the outside environment and personnel will observe institutional radiation safety precautions. A radiation safety officer will instruct the patient, family, and caretakers about specific UCSF radiation safety guidelines for both hospitalization and discharge.
16202143|NCT01377519|Procedure|MR Guided Focused Ultrasound|This is an FDA approved noninvasive treatment for fibroids that uses highly focused ultrasound waves to damage fibroid tissue.
16202144|NCT01377519|Procedure|Placebo MR Guided Focused Ultrasound|This is a placebo treatment that requires a participant to undergo identical procedures as those of the actual MR Guided Focused Ultrasound procedure, but higly focused ultrasound waves are not directed at the uterine fibroid.
16202145|NCT01377506|Behavioral|lifestyle counseling|21 session group-based behavioral weight management program delivered in senior center over 12 months by lay health educators
16202146|NCT01377506|Behavioral|Cognitive Training|21 session group-based cognitive training program delivered in senior center over 12 months by lay health educators
16202147|NCT01377493|Dietary Supplement|chewing gum|chewing gum containing no active ingredients, or Ca-P bioavailable ions, or Ca-P and F bioavailable ions
16202148|NCT01377480|Drug|Posaconazole|POS 40 mg/mL oral suspension
16202149|NCT01377480|Drug|Placebo for posaconazole|Placebo oral suspension
16202150|NCT01377480|Drug|Benznidazole|BNZ 100 mg oral tablet
16202151|NCT01377467|Drug|Denosumab (Prolia)|60 mg s.c. injection at baseline and after 6 months
16202152|NCT01377441|Drug|Ibuprofen|Patients will receive either 800mg IV ibuprofen or placebo pre-operatively. Post-operatively, patients will receive either 800mg IV ibuprofen or placebo 6 hours after the first dose.
16202153|NCT01377441|Drug|Placebo/Saline solution|Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose.
16202154|NCT01377428|Drug|Indacaterol|Indacaterol 150 µg once daily (od) via single-dose dry powder inhaler (SDDPI)
16202155|NCT01377428|Drug|Formoterol|Formoterol 12 µg twice daily (bid) via single-dose dry powder inhaler (SDDPI)
16202156|NCT01377415|Drug|bupivacaine|bupivacaine 5 mg/ml infusion 2 ml/h 48 h
16202157|NCT01377389|Drug|Ipilimumab|10 mg/kg by vein over 90 minutes once every 4 weeks, for 4 weeks.
16202158|NCT01377389|Drug|Leuprolide|7.5 mg intramuscular once a month for 8 months
16202159|NCT01377389|Drug|Goserelin|3.6 mg subcutaneous once a month for 8 months
16202160|NCT01377389|Drug|Degarelix|80 mg subcutaneous once a month for 8 months
16202161|NCT01377376|Drug|ARQ 197 and Erlotinib|Oral twice daily administration of ARQ197 and oral once daily administration of erlotinib
16202162|NCT01377376|Drug|Placebo and Erlotinib|Oral twice daily administration of placebo and oral once daily administration of erlotinib
16202163|NCT01377350|Device|"Pneumedicares monitoring system."|50 patients hospitalized due to the decompensated HF are considered for entry. 3 patches will be attached to the patients' thorax that include motion sensors. The system will be attached to the patients at the start of treatment. Patient's signals will be recorded during the entire treatment in the hospital, to the point that there is an improvement in their health condition.
16202164|NCT01377350|Device|"Pneumedicares monitoring system"|Non invasive clinical follow-up of patients with HF deterioration and improvement, by a device-based algorithm. The system comprises of patches attached to the patients' thorax that include motion sensors (Accelerometers) that measure the chest wall dynamics and the mechanics of lung inflation and deflation.
16202165|NCT01377337|Drug|sodium bicarbonate|"1 mEq/kg sodium bicarbonate administered intravenously immediately following the administration of the first epinephrine dose during advanced CPR. Dose may be repeated every 5-10 minutes up to 3 doses.
~Note: The Placebo Arm receives 1 ml/Kg of 0.9% NaCl (in a blinded fashion)."
16202166|NCT01377324|Other|Diagnostic intervention: Positron Emission Tomography with 16-alpha-[18-fluoro]-17betaestradiol|A FES-PET/(CT) will be performed thrice during protocol execution. Patients will be injected with ~200MBq 18F-FES
16202167|NCT01377311|Procedure|Transplant of cultured limbal stem cells on cornea|Remove the abnormal surface tissue on the lesion cornea, transplant the amniotic membrane with cultured limbal stem cells on the denuded cornea. Cover with contact lens after operation, and apply topical antibiotics and steroids.
16202168|NCT01377298|Drug|Pazopanib|200mg/tablet, 800mg/day PO.
16202169|NCT01377285|Drug|ARB|"Angiotensin II receptor antagonists ,these medicines have names that end in sartan.For examples:losartan,candesartan,irbesartan,olmesartan,telmisartan,valsartan"
16202170|NCT01377285|Drug|Pentoxifylline|This medication is used to improve the symptoms of a certain blood flow problem in the legs/arms (intermittent claudication due to occlusive artery disease)
16202171|NCT01377285|Drug|Placebo (for Pentoxifylline)|Sugar pill manufactured to mimic Pentoxifylline 400mg tablet
16202172|NCT01377259|Other|tissue oxygen saturation, spinal anesthesia|regional tissue oxygen saturation(rSO2)detected over upper and lower extremities before and after spinal anesthesia
16202173|NCT01377246|Drug|Octreotide-LAR|40 mg every 28 days (in two intragluteal 20 mg injections) for three years
16202174|NCT01377246|Other|Saline solution.|At the same volume of study drug every 28 days (in two intragluteal injections) for three years.
16202175|NCT01377233|Drug|Zicronapine open-label lead-in 10 mg daily|Encapsulated tablet ,10 mg, once daily, open-label
16202176|NCT01377233|Drug|Zicronapine 10 mg daily|Encapsulated tablet, 10 mg, once daily, double-blind
16202177|NCT01377233|Drug|Zicronapine 20 mg once weekly|Encapsulated tablet, 20 mg, once weekly (on day 1 of each 7 day cycle), double-blind
16202178|NCT01377233|Drug|Zicronapine 30 mg once weekly|Encapsulated tablet, 30 mg, once weekly (on day 1 of each 7 day cycle), double-blind
16202179|NCT01377233|Drug|Zicronapine 45 mg once weekly|Encapsulated tablet, 45 mg, once weekly (on day 1 of each 7 day cycle), double-blind
16202180|NCT01377220|Drug|11C-Choline|11C-Choline : 6MBq/kg on direct intravenous on one minute.
16202187|NCT01377155|Drug|Insulin detemir|Subjects will be randomized to weight based method of 0.1 U/kg for basal insulin or a starting dose based upon an insulin challenge. Subject will record morning fasting blood sugar daily. Using a three day average, the subject will titrate the dose of basal insulin either increasing or lowering by three units based upon target blood glucose of 110 mg/dl.
16202188|NCT01377142|Device|Laparoscopic sacral hysteropexy|Laparoscopic sacral hysteropexy is performed laparoscopically with or without robotic assistance
16202189|NCT01377142|Device|Vaginal mesh hysteropexy|Uphold device used which includes sacrospinous ligament fixation
16202190|NCT01377129|Procedure|Single bundle anterior cruciate ligament reconstruction|Single bundle anterior cruciate ligamentoplasty
16202191|NCT01377129|Procedure|Double bundle anterior cruciate ligament reconstruction|Double bundle anterior cruciate ligamentoplasty
16202192|NCT01377103|Drug|testerone gel|5g daily for 4 weeks then 7.5 or 10g daily for 8 weeks; transdermal testosterone gel
16202193|NCT01377103|Drug|Placebo|
16202194|NCT01377077|Procedure|punchgrafting|autologous skin transplantation of small skinbiopsies taken from the hip and replaced in the depigmented lesions
16202195|NCT01377077|Procedure|punchgrafting|autologous skingrafting of small skin biopsies taken from the hip en placed in the depigmented lesions
16202196|NCT01377064|Behavioral|Physical Activity Group|9 months of home based physical activity meeting HHS recommendations for physical activity for all americans
16202197|NCT01377064|Other|Standard Care Group|No intervention, the group will be followed under their standard medical care.
16202198|NCT01377051|Drug|Indacaterol maleate|Dry powered, 300 mcg, only one inhalation with 24 hours duration
16202199|NCT01377051|Drug|Placebo|Dry powered, same to study drug, only one inhalation
16202200|NCT01377038|Other|Phenotype assessment|Quantitative sensory testing and patient reported outcome measures used to assess patient pain phenotype
16202201|NCT01377025|Drug|Placebo|two tablets in the morning and two in the evening.
16202202|NCT01377025|Drug|Sorafenib|400 mg Sorafenib bid until PD if staging after Run-In was PR or CR
16202203|NCT01377025|Drug|Sorafenib|400 mg Sorafenib bid until PD if staging after Run-In was SD
16202204|NCT01377012|Biological|Secukinumab (AIN457)|AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL- 17). AIN457 was given as i.v. (10mg/kg) at baseline, week 2 and week 4, and then s.c. (75 or 150mg) every 4 weeks starting at week 8.
16202205|NCT01377012|Biological|Placebo|Placebo was given as i.v. at baseline, week 2 and week 4, and then s.c. every 4 weeks starting at week 8.
16202206|NCT01376999|Drug|FSH-r (Follicule stimulate hormone)|Step-Up: 75 IU FSH-r Step-Down: 150 FSH-r
16202207|NCT01376986|Behavioral|physical, psychological and social activation|
16202208|NCT01376960|Procedure|elective forefoot surgery|Includes both soft-tissue and osseous procedures.
16202209|NCT01376934|Procedure|procedure hysteroscopy|office hysteroscopy with gas or saline solution
16202210|NCT01376921|Device|easypod™|Saizen (Somatotropin) as per Summary of Product Characteristics (SmPC) administered by easypod™
16202211|NCT01376908|Drug|Kuvan®|Kuvan® (sapropterin dihydrochloride) tablets will be administered orally at the dose of 10 mg/kg/day and will be escalated to 20 mg/kg/day if after 4 weeks a subject's Phe tolerance is not increased by at least 20% versus baseline.
16202212|NCT01376908|Other|Phenylalanine (Phe)-restricted diet|Phe intake will be adjusted every 2 weeks, based on the mean Phe levels of the previous 2 weeks using pre-defined Phe adjustment criteria.
16202213|NCT01376895|Behavioral|PROJECT POWER|POWER is a three session intervention to help Black men who have sex with men and women lead healthier lives, make informed sexual choices and reduce their chances of getting or giving HIV to their sex partners. Interventions are designed to be delivered via the internet in real time by a trained health educator. Each session will last between 1 and 2 hours. The sessions are grounded on the social learning theory and use cognitive behavioral approaches. Participants learn the multiple influences on their behavior, how to identify their triggers and then use problem solving skills to develop a safer strategy for life. The sessions use videos and games to teach the lessons; participants are also given work that they must complete between the sessions.
16202214|NCT01376895|Behavioral|Power Health|Power Health is a one session intervention designed to help Black men who have sex with men and women improve their general health. It focuses on health issues (including HIV) that affect Black men. The program consists of 1 session delivered via the internet in real time by a trained health educator and last approximately 2 hours
16202215|NCT01376882|Dietary Supplement|Placebo|Inert placebo containing silica powder CAB-O-SIL-M-5Pharma (Pharmaceutical grade)CABOT GmbH. 1 Size 0 capsule 3 times a day for 14 days and 1 size 0 capsule on day 15.
16202216|NCT01376882|Dietary Supplement|Caffeine and Placebo|100 mg Caffeine capsules 3 times per day for 14 days and 1 size 0 capsule of inert placebo containing silica powder CAB-O-SIL-M-5Pharma (Pharmaceutical grade)CABOT GmbH on day 15.
16202217|NCT01376882|Dietary Supplement|Placebo and Caffeine|Inert placebo capsules containing silica powder CAB-O-SIL-M-5Pharma (Pharmaceutical grade)CABOT GmbH, 1 Size 0 capsule 3 times a day for 14 days and a 100mg caffeine capsule on day 15.
16202218|NCT01376882|Dietary Supplement|Caffeine|Capsule containing 100 mg caffeine, one 3 times a day for 14 days and then one capsule on day 15.
16202219|NCT01376869|Dietary Supplement|Hops Extract|All 150 participants will complete 1 study visit; receiving either of the 4 hops doses or placebo (silica). Computer generated random numbers will be used to allocate treatments to participant identification numbers. Treatment will be administered in capsule form and in a double blind manner.
16202220|NCT01376869|Other|Placebo (silica)|All 150 participants will complete 1 study visit; receiving either of the 4 hops doses or placebo (silica). Computer generated random numbers were used to allocate treatments to participant identification numbers. Treatment will be administered in capsule form and in a double blind manner.
16202221|NCT01376817|Drug|Fat emulsion with MCT, LCT, olive oil and omega 3 fatty acids|40% of non-protein calories (25-30 kcal/kg/day) of total parenteral nutrition, IV (in the vein), from day 1 to day 10
16202222|NCT01376817|Drug|Fat emulsion with MCT and LCT|40% of non-protein calories (25-30 kcal/kg/day) of total parenteral nutrition, IV (in the vein), from day 1 to day 10
16202223|NCT01376804|Drug|valganciclovir [Valcyte]|Oral, daily for up to 200 days.
16202305|NCT01376167|Drug|Chloroquine 300mg|300mg Chloroquine given to each subject on Day 3 of the trial
16202224|NCT01376778|Drug|CMV hyperimmune globulin|The study's active drug is Cytogam® which is an immunoglobulin G (IgG) containing a standardized amount of antibody to CMV. This drug contains pooled adult human plasma selected for high titers of antibody for CMV, and is administered intravenously at a dose of 100 mg/kg body weight.
16202225|NCT01376778|Other|Placebo|The matching placebo consists of AlbuRx® 5% diluted 1:9 with D5W. AlbuRx® 5% contains pooled adult human plasma.
16202226|NCT01376765|Drug|Aluminum hydroxide adjuvant (Alhydrogel®)|Aluminum hydroxide adjuvant (Alhydrogel®);given with SARS vaccine; 2 intramuscular doses, 28 days apart, Cohort 1: 12 subjects given vaccine with adjuvant at 5 micrograms per dose; Cohort 2: 12 subjects given vaccine with adjuvant at 15 micrograms per dose; Cohort 3: 12 subjects given vaccine with adjuvant at 45 micrograms per dose
16202227|NCT01376765|Other|Phosphate buffered saline Placebo|Phosphate buffered saline Placebo; 2 intramuscular doses, 28 days apart. Cohort 1: 4 subjects given placebo at 5 micrograms per dose; Cohort 2: 4 subjects given placebo at 15 micrograms per dose; Cohort 3: 4 subjects given placebo at 45 micrograms per dose
16202228|NCT01376765|Biological|Recombinant S protein SARS vaccine|Recombinant S protein severe acute respiratory syndrome (SARS) vaccine given with adjuvant or without adjuvant; 2 intramuscular doses, 28 days apart, Cohort 1: 12 subjects given vaccine only or vaccine with adjuvant at 5 micrograms per dose; Cohort 2: 12 subjects given vaccine only or vaccine with adjuvant at 15 micrograms per dose; Cohort 3: 12 subjects given vaccine only or vaccine with adjuvant at 45 micrograms per dose
16202229|NCT01376752|Procedure|Maximal cytoreductive surgery|Maximal cytoreductive surgery
16202230|NCT01376752|Drug|HIPEC|HIPEC: Hyperthermic Intra-PEritoneal Chemotherapy. Administration of cisplatin at 75mg/m²
16202231|NCT01376739|Drug|Gadopentetate dimeglumine (Magnevist, BAY86-4882)|Patients who will need to undergo contrast enhanced MR angiography with Magnevist (a dosage of more than 0.2 mg/kg)
16202232|NCT01376726|Biological|Sub C gp140 Vaccine|"Sub C gp140 100 mcg will be combined with MF59C.1 and administered as one injection (0.5 mL) IM in either deltoid at baseline and Month 6.
~Participants in the study extension will receive an additional injection of the study vaccine approximately 14 to 20 months after their second (Month 6) vaccination."
16202233|NCT01376726|Biological|MF59C.1 Adjuvant|"Sub C gp140 100 mcg will be combined with MF59C.1 and administered as one injection (0.5 mL) IM in either deltoid at baseline and Month 6.
~Participants in the study extension will receive an additional injection of the study vaccine approximately 14 to 20 months after their second (Month 6) vaccination."
16202234|NCT01376713|Biological|Ofatumumab|Ofatumumab will be administered at a dose of 1000mg iv weekly for 8 weeks and q4w for another 16 weeks
16202235|NCT01376713|Biological|Ofatumumab plus Dacarbazine|"Ofatumumab will be administered at a dose of 1000mg iv weekly for 8 weeks and q4w for another 16 weeks.
~Dacarbazine administered q4w at a dose of 1000mg/m2, 4 days before next administration of Ofatumumab for 24 weeks."
16202236|NCT01376700|Biological|Recombinant antihemophilic factor, plasma/albumin-free method (rAHF-PFM)|Intravenous infusion at a dose of 25 ± 5 IU/kg once per week. After 20 exposure days, the weekly infusions should be continued for as long as possible following the early prophylaxis period. If required by the clinical situation, dosing may be increased to twice weekly or even three times weekly after 20 exposure days, while keeping the low dose.
16202237|NCT01376596|Behavioral|Cognitive-Behavioral Therapy based intervention immediately|This intervention will include: i) Psychoeducation on social anxiety disorder; ii) Cognitive Restructuring: Identify negative thoughts that occur before, during, or after anxiety-provoking situations; Evaluate the accuracy of their thoughts in the light of data derived from Socratic questioning or as a result of so-called behavioral experiments; and derive rational alternative thoughts based on the acquired information; iii) Exposure component, which focuses on the collection of information that will allow patients to revise their judgments about the degree of risk to which they are exposed in feared situations, challenge their dysfunctional beliefs about the self relative to the illness and their self-efficacy (social status related), and iv) Use of Thought Records to identify, explore and dispute negative thoughts about dysfunctional self-identity and core beliefs related to the onset and presence of diagnosis of schizophrenia.
16202238|NCT01376596|Behavioral|Wait list|The group receiving treatment as usual (TAU) will be put on a wait list to receive the CBT intervention at the end of the experimental group, the one receiving the intervention immediately
16202239|NCT01376570|Behavioral|Abstinence-reinforcing contingency management intervention|The contingency management intervention consists of participants receiving vouchers exchangeable for goods and services contingent on achieving abstinence. When participants are abstinent (urine is free of cocaine, oxycodone and opiates), they will receive a voucher. If participants are not abstinent (cocaine or oxycodone or opiates are in the urine), they will not receive a voucher. The value of vouchers increases with continued evidence of abstinence. When participants have urines with opiates or cocaine, the value of the voucher is reset. The vouchers are part of the intervention, they are not participant compensation.
16202240|NCT01376570|Behavioral|Performance Feedback intervention|Participants will receive performance feedback about their drug use. The research team will provide informational slips of paper indicating results of urine tests and will congratulate participants when urines are drug-free or encourage participants to stop using cocaine and/or opiates when urines are not drug-free.
16202241|NCT01376557|Drug|75 mg LX4211|Subjects will receive 75 mg LX4211 once daily
16202242|NCT01376557|Drug|200 mg LX4211|Subjects will receive 200 mg LX4211 once daily.
16202243|NCT01376557|Drug|400 mg LX4211|Subjects will receive 400 mg LX4211 once daily.
16202244|NCT01376557|Drug|200 mg LX4211|Subjects will receive 200 mg LX4211 twice daily.
16202245|NCT01376557|Drug|Placebo|Subjects will receive placebo once daily.
16202246|NCT01376544|Device|Treatment protocol designed to evaluate (SLE 5000 ventilator)|Assist control ventilation and pressure support ventilation
16202247|NCT01376531|Procedure|continuous veno-venous hemodialysis|continuous veno-venous hemodialysis
16202248|NCT01376518|Procedure|positive end-expiratory pressure|Elevation of positive end-expiratory failure for recruitment
16202306|NCT01376167|Drug|Tafenoquine 50mg|single dose 50mg Tafenoquine given to subject on treatment arm 1 on Days 1 or 2
16202307|NCT01376167|Drug|Tafenoquine 100mg|single dose 100mg Tafenoquine given to subject on treatment arm 2 on Days 1 or 2
16202308|NCT01376167|Drug|Tafenoquine 300mg|single dose 300mg Tafenoquine given to subject on treatment arm 3 on Days 1 or 2
16202708|NCT01372774|Radiation|stereotactic radiosurgery|Undergo RT
16202251|NCT01376492|Other|Functioning assessment|The functioning will be assessed with 2 scales, (Personal and Social Performance Scale (PSP) and Brief Psychiatric Rating Scale)
16202252|NCT01376492|Other|Quality of sleep assessment|The quality of sleep will be assessed with 2 scales, (Pittsburgh Sleep Quality Index (PSQI) and Epworth scale)
16202253|NCT01376479|Biological|INV21 Low Dose|Inactivated EV71 vaccine containing whole viral particles of EV71 formulated with aluminum hydroxide.
16202254|NCT01376479|Biological|INV21 High Dose|Inactivated EV71 vaccine consisting of whole viral particles of EV71 formulated with aluminum hydroxide.
16202255|NCT01376479|Biological|Placebo|Phosphate Buffered Saline (PBS)
16202256|NCT01376466|Other|CT scanning|CT image of the abdomen included the area between the 3rd. lumber vertebra and the top of acetabulum. A liter of contrast mixed with normal salin will be given by rectal catheter 20 minutes before CT image is taken.
16202257|NCT01376453|Drug|Sorafenib|In addition to radiation and 5-FU, sorafenib will be taken by mouth daily every day until the last day of radiation. The dose of sorafenib will be one of the following: 200 mg every other day, 200 mg daily, 400 mg daily, or 800 mg daily
16202258|NCT01376453|Drug|5-Fluorouracil (5-FU)|5-FU will be delivered at a dose of 225 mg/m^2 daily through a catheter in a large vein continuously until the last day of radiation.
16202259|NCT01376453|Radiation|Radiation|Radiation sessions will be daily, Monday through Friday, except for holidays.
16202260|NCT01376440|Other|household water treatment|household water treatment with 1.25% sodium hypochlorite
16202261|NCT01376427|Drug|Dexamethasone|Dexamethasone
16202262|NCT01376427|Drug|Methotrexate|Methotrexate
16202263|NCT01376427|Drug|Vincristine|Vincristine
16202264|NCT01376414|Other|Urea Breath Test (UBT) for H. pylori infection|13C UBT to detect H. pylori infection. Single bedside test that determines infection in about ten minutes. Test machine is a product of Exalenz bioscience.
16202265|NCT01376401|Drug|Bendamustine|
16202266|NCT01376401|Drug|Velcade|
16202267|NCT01376401|Drug|Prednisone|
16202268|NCT01376388|Drug|GSK573719/GW642444 Inhalation Powder|GSK573719/GW642444 inhalation powder inhaled orally once daily for 52 weeks.
16202269|NCT01376375|Procedure|Acupuncture|
16202270|NCT01376362|Drug|Interferon Gamma-1b|Interferon gamma-1b (Actimmune®, InterMune, Inc, Brisbane, CA 94005) was supplied to participants in single-use dropperettes. Each dropperette contained approximately 0.2 mL of interferon gamma-1b (Actimmune®). Participants received 28 dropperettes at the baseline visit and were instructed to place four drops (approximately 7 μg per drop) topically on the cornea of the study eye four times per day for seven days.
16202271|NCT01376349|Drug|prasterone|Applied vaginally
16202272|NCT01376349|Other|placebo|Applied vaginally
16202273|NCT01376336|Device|Safe storage device|This device is a specially designed water storage container that is intended to reduce the likelihood of re-contamination of household stored drinking water.
16202274|NCT01376323|Drug|GSK256073 1mg|GSK256073 1mg capsule
16202275|NCT01376323|Drug|GSK256073 5mg|GSK256073 5mg capsule
16202276|NCT01376323|Drug|GSK256073 10mg|GSK256073 10mg capsule
16202277|NCT01376323|Drug|GSK256073 25mg|GSK256073 25mg capsule
16202278|NCT01376323|Drug|Placebo|placebo capsule
16202279|NCT01376323|Drug|Sitagliptin 100mg|Sitagliptin 100mg capsule
16202280|NCT01376310|Drug|GSK1120212|up to 2 mg/day
16202281|NCT01376310|Drug|Docetaxel + GSK1120212|dose as defined in the dose escalation protocol.
16202282|NCT01376310|Drug|Erlotinib + GSK1120212|dose as defined in the dose escalation protocol.
16202283|NCT01376310|Drug|Pemetrexed + GSK1120212|dose as defined in the dose escalation protocol
16202284|NCT01376310|Drug|Carboplatin + GSK1120212|dose as defined in the dose escalation protocol
16202285|NCT01376310|Drug|Nab-paclitaxel + GSK1120212|dose as defined in the dose escalation protocol
16202286|NCT01376310|Drug|Gemcitabine + GSK1120212|dose as defined in the dose escalation protocol
16202287|NCT01376310|Drug|Everolimus + GSK1120212|dose as defined in the dose escalation protocol
16202288|NCT01376297|Drug|Netupitant and Palonosetron|
16202289|NCT01376297|Drug|Aprepitant|
16202290|NCT01376297|Drug|Palonosetron|
16202291|NCT01376297|Drug|Dexamethasone|
16202292|NCT01376284|Drug|Dutasteride|Collection of safety data
16202293|NCT01376271|Drug|Paroxetine|
16202294|NCT01376258|Drug|5ARI|dutasteride or finasteride
16202295|NCT01376245|Drug|fluticasone furoate/vilanterol|Inhaled corticosteroid/long acting beta-agonist
16202296|NCT01376245|Drug|Placebo|matching placebo
16202297|NCT01376232|Drug|GSK1278863|GSk1278863 100mg
16202298|NCT01376232|Drug|GSK1278863 + food|High Fat meal + 100 mg GSK1278863
16202299|NCT01376232|Drug|Gemfibrozil|600 mg Gemfibrozil
16202300|NCT01376219|Other|asthma control test|results of asthma control testing collected
16202301|NCT01376206|Drug|Fluticasone|Collection of safety data
16202302|NCT01376193|Drug|Naratriptan|Collection of safety data
16202303|NCT01376180|Drug|Lamotrigine|Administered according to the prescribing information in the locally approved label by the authorities
16202304|NCT01376167|Drug|Chloroquine 600mg|600mg Chloroquine given to each subject on Day 1 and Day2 of the trial
16202934|NCT01371162|Drug|placebo|multiple doses
16202309|NCT01376167|Drug|Tafenoquine 600mg|single dose 600mg Tafenoquine given to subject on treatment arm 4 on Days 1 or 2
16202310|NCT01376167|Drug|Primaquine 15mg|15mg Primaquine given once daily to subject on treatment arm 5 on Days 2 to 15.
16202311|NCT01376167|Drug|Chloroquine 600mg (Part 2 )|600mg Chloroquine given to each subject on Day 1 and Day2 of the trial.
16202312|NCT01376167|Drug|Chloroquine 300mg (Part 2 )|300mg Chloroquine given to each subject on Day 3 of the trial.
16202313|NCT01376167|Drug|Tafenoquine 300mg (Part 2)|single dose 300mg Tafenoquine given to subject on treatment arm 3 on Days 1 or 2.
16202314|NCT01376167|Drug|Primaquine 15mg (Part2 )|15mg Primaquine given once daily to subject on treatment arm 3 on Days 2 to 15.
16202315|NCT01376154|Drug|Lamivudine|
16202316|NCT01376141|Drug|Sumatriptan|
16202317|NCT01376128|Drug|Paroxetine|
16202318|NCT01376115|Drug|Nelarabine|
16202319|NCT01376102|Drug|BONVIVA(ibandronate) injection|Basically there is no treatment allocation. Subjects who would be administered of ibandronate at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.
16202320|NCT01376089|Drug|Iodixanol|Iodixanol 320 mg I/mL as a single iv. administration.
16202321|NCT01376089|Drug|Iopamidol|Comparator agent iopamidol (Isovue) 370 mg I/mL as a single iv. administration.
16202322|NCT01376076|Drug|Cariprazine|Patients meeting all study eligibility criteria will be randomized to receive cariprazine (Group 1) 1.5 to 18 mg once daily, administered orally.
16202323|NCT01376076|Drug|Risperidone/Moxifloxacin|Patients randomized to Group 2A will receive double blind placebo for Days 1-5, Moxifloxacin (400mg) on Day 6, Risperidone 4mg once daily Days 7-15, placebo Days 16-20, Risperidone Days 21-29, placebo Days 30-35.
16202324|NCT01376076|Drug|Risperidone/Moxifloxacin|Patients randomized to Group 2B will receive double blind placebo for Days 1-6, Risperidone 4mg once daily Days 7-15, placebo Days 16-20, Risperidone Days 21-29, placebo Days 30-34, Moxifloxacin (400mg) on Day 35.
16202325|NCT01376063|Drug|FG-4592|"FG-4592 on days 3,5,7,9
~Rosiglitazone maleate on days 1 and 9"
16202326|NCT01376050|Device|Erchonia ML Scanner (MLS)|Erchonia MLS comprises three 17.5 mW 635 nm diodes. The center diode is fixed at 6 inches above the venous stasis ulcer center and the other 2 diodes rotate about this center fixed diode for 20 minutes. Total dosage delivered to the skin is 2.95 J/cm squared.
16202327|NCT01376050|Device|Placebo Laser|Placebo Laser has no therapeutic output emitted.
16202328|NCT01376037|Device|Erchonia(r) ML Scanner (MLS)|The Erchonia ML Scanner (MLS) low level laser light therapy device is administered to both arms for 20 minutes each, 6 times across 2 weeks.
16202329|NCT01376037|Device|inactive placebo laser device|non-therapeutic light application
16202330|NCT01376011|Dietary Supplement|quercetin/placebo|Quercetin 500mg once per day versus placebo
16202331|NCT01375998|Drug|EE20/DRSP(YAZ, BAY86-5300)|Patients in daily life treatment receiving YAZ for dysmenorrhea.
16202332|NCT01375985|Drug|AVI-7100|Single intravenous administration
16202333|NCT01375985|Drug|Placebo|Single intravenous administration
16202334|NCT01375972|Drug|S-1 plus cisplatin|S-1 40 mg/m2 D1-D14 Cisplatin 60 mg/m2 D1 every 3 weeks
16202335|NCT01375972|Drug|Gemcitabine plus Cisplatin|Gemcitabine 1000 mg/m2 IV D1, D8 Cisplatin 60 mg/m2 IV D1 Every 3 weeks
16202336|NCT01375959|Dietary Supplement|resveratrol|resveratrol 500 mg capsules, 3 capsules (1500 mg) orally twice a day for 6 weeks
16202337|NCT01375959|Drug|Placebo|3 placebo capsules orally twice a day for 6 weeks
16202338|NCT01375946|Drug|AG200-15|There will be three treatment periods. Subjects will be randomly assigned to one of the five conditions for the treatment period. The subject will be exposed daily to the condition assigned while wearing the patch. The study patch will be worn for a 7 day treatment period, followed by a 7 day washout period. The total duration of the study is 6 weeks.
16202339|NCT01375933|Biological|NicVAX Vaccine|NicVAX Vaccine given 6 times over 6 months
16202340|NCT01375920|Drug|Metyrapone|500 milligrams to be taken twice a day orally
16202341|NCT01375920|Drug|placebo|a matched placebo will be administered to patients to take twice a day for 3 weeks
16202342|NCT01375907|Drug|Rotavin|Rotavin-M1, 10e6.3FFU/dose, 2 doses, 1-month between doses
16202343|NCT01375894|Device|"imitation assessment using the 5-dt data glove."|measuring the speed of the hand during imitation
16202344|NCT01375881|Drug|darunavir/ritonavir plus background regimen|darunavir/ritonavir, oral use, in naive and experienced patients at approved dosages
16202345|NCT01375868|Biological|Silgard|vaccination with tetravalent antiviral vaccine
16202346|NCT01375855|Procedure|Percutaneous transluminal Coronary Angioplasty|Coronary artery stent implantation
16202347|NCT01375842|Drug|Atezolizumab|Atezolizumab will be administered as IV infusion at eight dose levels (0.01, 0.03, 0.1, 0.3, 1, 3, 10, 20 mg/kg) in dose escalation cohort and at a dose which result in total drug exposure </= exposures achieved at the MTD or MAD, will be selected for expansion cohort.
16202348|NCT01375829|Drug|Ixabepilone|Given IV
16202349|NCT01375829|Other|Pharmacological Study|Correlative studies
16202350|NCT01375829|Drug|Temsirolimus|Given IV
16202351|NCT01375816|Drug|FOLFIRI 1-Bevacizumab|
16202352|NCT01375816|Drug|fluorouracil|
16202353|NCT01375816|Drug|irinotecan hydrochloride|
16202354|NCT01375816|Drug|leucovorin calcium|
16202355|NCT01375816|Drug|liposome-encapsulated irinotecan hydrochloride PEP02|
16202356|NCT01375816|Drug|Bevacizumab|
16202357|NCT01375803|Dietary Supplement|Novel dietary fiber|oral consumption in beverage
16202358|NCT01375803|Dietary Supplement|Novel dietary fiber|Oral consumption in beverage
16202359|NCT01375803|Other|Placebo|Oral consumption in beverage
16202360|NCT01375790|Device|Exercise with Whole-body vibration platform|The participants will perform static/dynamic exercises (balance and resistance training) on a vibratory platform (Frequency: 30-35 Hz; Amplitude: 2-4 mm).
16202361|NCT01375790|Other|Exercise|The participants will perform the same static/dynamic exercises (balance and resistance training) like WBV group but without the vibration stimuli.
16202362|NCT01375777|Biological|Evolocumab|Administered by subcutaneous injection
16202363|NCT01375777|Drug|Ezetimibe|Administered orally once a day
16202364|NCT01375777|Other|Placebo to Evolocumab|Administered by subcutaneous injection
16202365|NCT01375764|Biological|Evolocumab|Administered by subcutaneous injection
16202366|NCT01375764|Drug|Ezetimibe|Administered orally once a day
16202367|NCT01375764|Other|Placebo to Evolocumab|Administered by subcutaneous injection
16202368|NCT01375751|Biological|Evolocumab|Administered by subcutaneous injection
16202369|NCT01375751|Biological|Placebo|d by subcutaneous injection
16202370|NCT01375738|Procedure|Roux-en Y gastrojejunostomy|After subtotal gastrectomy with lymph node dissection, the jejunum is transected 25~30cm distal to the ligament of Treitz. Distal jejunum is drawn up and sutured to the gastric remnant and the proximal jejunum is anastomosed to the distal jejunum at 30~40cm from the new gastric-jejunal junction.
16202371|NCT01375738|Procedure|Gastroduodenostomy|After subtotal gastrectomy with lymph node dissection, the gastric remnant is anastomosed to duodenum 1st portion with circular or linear staplers and the artificial lesser curvature is repaired with linear stapler.
16202372|NCT01375712|Dietary Supplement|Fermented milk containing Lactobacillus casei strain Shirota|A fermented milk containing Lactobacillus casei strain Shirota, 65 ml for oral administration, 1 bottle per day for 8 weeks (56 days). One bottle of the drink contains: 42.9 kcal/182 kJ; less than 0.1 g of fat; 9.6 g of carbohydrate; 0.01 g of sodium; 0.9 g of protein; and at least 6.5 x 10^9 colony-forming units of Lactobacillus casei strain Shirota.
16202373|NCT01375712|Dietary Supplement|Placebo|Non-fermented milk without Lactobacillus casei strain Shirota, 65 ml for oral administration, 1 bottle per day for 8 weeks (56 days). One bottle of the drink contains: 42.9 kcal/182 kJ; less than 0.1 g of fat; 9.6 g of carbohydrate; 0.01 g of sodium; and 0.9 g of protein.
16202374|NCT01375699|Drug|Doxorubicin|As prescribed by treating provider.
16202375|NCT01375699|Drug|Sildenafil|Given PO, by mouth
16202376|NCT01375673|Other|Exercise|Walking Strength Training Bicycling
16202377|NCT01375660|Drug|Placebo|Supplement of vitamin D 400 units provided to all subjects, in addition Arm 1 will get placebo and Arm 2 will get D2 50K
16202378|NCT01375660|Drug|50K vitamin D2|Supplement of vitamin D 400 units provided to all subjects, in addition Arm 1 will get placebo and Arm 2 will get D2 50K
16202379|NCT01375647|Biological|IPV|Administered per protocol
16202380|NCT01375647|Biological|Rotarix|Administered per protocol
16202381|NCT01375634|Drug|Midazolam|2 mg intravenous over 2 minutes For patients >60 years of age or with history of pulmonary disease, 1 mg intravenous over 2 minutes
16202382|NCT01375608|Drug|Decitabine|0.2mg/kg (range, 0.05-0.3 mg/kg) 1-2X/wk for a period of 48 weeks. Dose and frequency will be determined by hematologic toxicity and the achievement of an HbF level of greater the or equal to 20 percent.
16202383|NCT01375582|Drug|B & L Soothe Lubricant Eye Drops|Eye Drop
16202384|NCT01375582|Drug|Liposic EDO|Eye Drop
16202385|NCT01375582|Drug|OcuFresh Eye Wash|Saline drop
16202386|NCT01375569|Drug|TRC105|
16202387|NCT01375556|Drug|Ethanol|
16202388|NCT01375504|Behavioral|Dietary Counseling|The control group will receive two sessions of dietary counseling (with instruction to follow a weight loss program) provided by a clinical dietician, consistent with current routine care for adults with obesity.
16202389|NCT01375504|Behavioral|Mindfulness Training Program|The mindfulness program will be administered over three 90-minute sessions by a physician and clinical dietician with expertise in mind-body medicine and nutrition.
16202390|NCT01375491|Drug|Doxycycline|generic doxycycline 100mg twice daily
16202391|NCT01375491|Other|Placebo|Placebo comparator to doxycycline
16202392|NCT01375465|Device|DIOR drug-eluting PTCA balloon|Treatment for 45 seconds with the DIOR balloon (3 µg/mm2 Paclitaxel concentration on balloon surface)
16202393|NCT01375452|Drug|Letrozole|Letrozole Tablets 2.5 mg of Dr.Reddy's Laboratories Limited
16202394|NCT01375439|Other|Active search of lower genital tract infections|Two groups (G1 and G2) will be part of study, each one composed of 140 pregnant women with a history of premature birth, G1 will have the active search and etiologic diagnosis of lower genital tract infections and G2 do not search of these infections, keeping for this group, the protocol of routine care of basic health units in the city of Botucatu. Workup care of pregnant women (G1) will include the completion of direct examination of vaginal contents stained by Gram's method, culture in the medium of Diamonds and polymerase chain reaction (PCR) of endocervical secretions, collected by health services in primary care the municipality in two moments: before 20th pregnancy week (M1) and in 36th pregnancy week (M2). The moment M3 will be after the birth, to evaluate the perinatal outcome.
16202395|NCT01375426|Drug|Oral amoxicillin|
16202396|NCT01375413|Behavioral|physical therapy|Physical therapy consisting of gait training 3 times a week for 6 weeks
16202397|NCT01375400|Drug|Aspirin|Administration of 300 mg of aspirin, per os.
16202398|NCT01375400|Biological|blood sample|2 blood samples will be performed
16202399|NCT01375387|Drug|Lacosamide|100 mg oral tablet, single dose
16202400|NCT01375387|Drug|Lacosamide|Lacosamide 2 X 100 mg tablet
16202401|NCT01375387|Drug|Lacosamide|Lacosamide 4 X 100mg tablet
16202402|NCT01375387|Other|Placebo 3|Placebo - 3 tablets
16202403|NCT01375387|Other|Placebo 4|Placebo - 4 tablets
16202404|NCT01375387|Other|Placebo 2|Placebo - 2 tablets
16202405|NCT01375374|Drug|Lacosamide|4-Week Titration Period: start dose Lacosamide (LCM) is 100 mg/day - up-titration of 100 mg/week LCM 8-Week Maintenance Period: dose can change first 4 weeks with 100 mg/week, must remain between 300 mg/day and 600 mg/day. Dose must remain stable last 4 weeks.
16202406|NCT01375374|Drug|Levetiracetam|Levetiracetam (LEV) is taken at a stable dose 30 days before study entry and is ≥ 1000 mg/day at the first visit. The LEV dose may not be changed at any time.
16202407|NCT01375361|Drug|Albuterol|2.5mg Albuterol inhaled on enrollment and at 4 hours in the emergency department.
16202408|NCT01375361|Drug|Normal Saline|2.5mg Normal Saline inhaled on enrollment and at 4 hours in emergency department.
16202409|NCT01375348|Drug|Ultiva (remifentanil) or placebo|0.1microg/kg/min remifentanil administered as infusion Max infusion time is 20min
16202410|NCT01375335|Drug|Dobutamine|90 minutes of infusion 5 ug/kg/minute followed by isotonic saline for the same duration. The sequence of the above is randomized
16202411|NCT01375322|Drug|Amlodipine+Benazepril|Amlodipine besylate 5 mg + Benazepril hydrochloride 10 mg, daily use and forced titrate till 16-week end
16202704|NCT01372787|Procedure|Assessment of Therapy Complications|Ancillary studies
16202412|NCT01375322|Drug|Valsartan+Hydrochlorothiazide|Valsartan 80 mg + Hydrochlorothiazide 12.5 mg, daily use and forced titrate till 16-week end
16202413|NCT01375309|Dietary Supplement|Bifidobacterium bifidum supplementation|Bifidobacterium bifidum supplementation wiht approximately 2.5*10to9th bacteria per day
16202414|NCT01375309|Dietary Supplement|Placebo contains dextrin|0.5 of dextrin
16202415|NCT01375296|Device|China-made SES (Firebird 2 and Excel)|patients with coronary 50-70% narrowing treated with China-made SES stent,i.e. Firebird 2 (cobalt-alloy platform with durable polymer coating sirolimus-eluting stent) and Excel (stainless steel platform with biodegradable polymer coating sirolimus-eluting stent).
16202416|NCT01375296|Other|routine medicine|patients with coronary 50-70% narrowing treated with routine medicine
16202417|NCT01375270|Procedure|Glucotoxicity|Glucose will be infused intravenously for a 24 hour period to raise blood glucose concentrations 5 mM above basal.
16202418|NCT01375270|Procedure|Lipotoxicity|Intralipid and heparin will be infused intravenously for a 24 hour period to raise blood free fatty acid concentrations to approximately 1 mM.
16202419|NCT01375257|Drug|Oral treatment with antibiotics for endocarditis|
16202420|NCT01375257|Drug|Guideline treatment with parenteral antibiotics|
16202421|NCT01375244|Drug|Lisinopril|Tablets, 10 mg, single dose
16202422|NCT01375244|Drug|Zestril|Tablets, 10 mg, single dose
16202423|NCT01375231|Procedure|Measured Resection of patellofemoral joint|The goal is to remove an amount of bone from the patella so that when reconstructed, the composite thickness of the entire prosthetic patellofemoral joint is recreated
16202424|NCT01375231|Procedure|Measured resection of patella|The thickness of the anterior condyle is not considered in this measurement. The goal is to restore the composite thickness of the patella only.
16202425|NCT01375218|Other|Pavlik Brace|Pavlik Brace
16202426|NCT01375218|Other|Plastizote Brace|Plastizote Brace
16202427|NCT01375205|Other|Cetaphil Restoraderm|Subjects will apply Cetaphil Restoraderm moisturizer once daily to infant's skin. They will bathe their infant with Cetaphil Restoraderm cleanser.
16202428|NCT01375205|Other|Standard of Care|Subjects will apply Johnson&Johnson moisturizer to their infant's skin as often as they wish. They will also use the Johnson&Johnson cleanser.
16202429|NCT01375179|Drug|KRP203|
16202430|NCT01375179|Drug|Placebo matching KRP203|
16202431|NCT01375153|Drug|BNP|3.0 pmol/kg/min human active BNP administered as a continuous intravenous infusion during four hours
16202432|NCT01375153|Drug|0.9% NaCl|0.9% NaCl administered as a continuous intravenous infusion during four hours
16202433|NCT01375140|Drug|Ruxolitinib|15 mg by mouth twice daily (BID), continuously in 28-day cycles.
16202434|NCT01375140|Drug|Lenalidomide|5 mg by mouth each day on days 1-21, followed by 7 days of no therapy of each 28 day cycle.
16202435|NCT01375140|Drug|Prednisone|"Prednisone will be added for patients who have not responded after 3 cycles of therapy.
~30 mg by mouth a day during cycle 4, 15 mg/day during cycle 5, and 15 mg every other day during cycle 6, and then it will be discontinued."
16202436|NCT01375127|Drug|Tofacitinib|Subjects who previously took 15 mg BID or 30 mg BID
16202437|NCT01375127|Drug|Tofacitinib|Subjects who previously took 15 mg BID for 3 months then 10 mg BID, or 15 mg BID for 6 months then 10 mg BID
16202438|NCT01375114|Drug|Panax Ginseng|400 mg by mouth twice daily from Day 1-29.
16202439|NCT01375114|Dietary Supplement|Placebo|Placebo by mouth twice daily for 4 weeks.
16202440|NCT01375114|Behavioral|Questionnaires|Completion of questionnaires taking about 30 minutes on Day 15 (± 3 days), Day 29 (± 3 days), and Day 57 (± 3 days), regarding symptoms such as fatigue, mood, depression, anxiety, nausea, appetite problems, sleep problems, and overall sense of well-being.
16202441|NCT01375101|Drug|placebo|The patient is directed to use placebo capsule two times a day, ,until the one mouth
16202442|NCT01375101|Drug|Quercetin|The patient is directed to digest quercetin hydrate capsule two times a day,until one mouth
16202443|NCT01375088|Drug|propolis|15 ml mouth wash 3 times a day for the whole period of radiotherapy for 5 min swish and then swallow
16202444|NCT01375075|Drug|LY2484595|Administered orally
16202445|NCT01375075|Drug|Placebo|Administered orally
16202446|NCT01375075|Drug|Atorvastatin|Administered orally
16202447|NCT01375062|Other|analyse and proliferate the cells|"Obtention of excess tissue from testicular biopsies and maintained in 4ºC until procedures.
~Digestion of the biopsies through controlled enzymes
~Replication of the cells
~Selection undifferentiated cells
~Expansion of the purification cells population
~Characterization of the cell population
~Assessment of pluripotent and germinal cell potential.
~Possible maturation of the cells."
16202448|NCT01375049|Drug|Aztreonam for Inhalation Solution (AZLI)|AZLI 75 mg administered 3 times daily via the investigational eFlow® nebulizer
16202449|NCT01375023|Radiation|Radiotherapy|daily radiation therapy for 10 days, total dose of 80 cGY
16202450|NCT01375023|Biological|Anti-Thymocyte Globulin|1.5 mg/kg/day, IV from day -11 through day -7 before transplantation
16202451|NCT01375010|Drug|Vitamin D3|2000 mg QD
16202452|NCT01375010|Other|Placebo|An inactive treatment that is intended to provide baseline measurements for the experimental protocol of a clinical trial, in this case, the vitamin D3.
16202453|NCT01375010|Drug|Vitamin Supplements|Specially formulated supplements (Tishcon, Inc.) that contain 500 mg of calcium (carbonate) and 500 IU of vitamin D3 to be taken twice daily with breakfast and dinner (1000 mg of elemental calcium and 1000 IU of vitamin D).
16202454|NCT01374997|Other|micromethod from samples taken from blood spots on filter paper|a blood test to measure the level of alpha-galactosidase A activity by micromethod from samples taken from blood spots on filter paper
16202455|NCT01374984|Biological|VIGIV|VIGIV is licensed in US, by the FDA, for the treatment of complications of smallpox vaccinations and is available to eligible patients regardless of participation in this study.
16202456|NCT01374971|Drug|Certolizumab Pegol (CZP)|CZP is an anti-TNF, humanized antibody Fab' fragment/polyethylene glycol(PEG)conjugate. CZP liquid formulation 200 mg sc -(initial loading dose of 400 mg sc at 0 (Baseline), 2, and 4 weeks), then 200 mg sc every 2 weeks at 6, 8, and 10 weeks.
16202500|NCT01374581|Drug|Artesunate/Amodiaquine|"Age (Weight in Kg) Dose Treatment duration 2 to 11 months (= 4,5 to < 9kg):1 tablet (25 mg/675mg) for 3 days
~1 to 5 years (= 9 kg to < 18 kg)1 tablet(25mg/67,5mg)for 3 days"
16202457|NCT01374971|Procedure|Arthroscopic synovial tissue biopsy|Subjects will undergo arthroscopy Pre and Post Treatment. The arthroscopy will be performed on a clinically inflamed joint. A single arthroscopy procedure using a small bore arthroscope will be conducted to obtain synovial tissue in each joint in all subjects. Local anesthesia will be used only. Two small incisions will be made to accommodate the arthroscope and other instruments. Synovial biopsies will be obtained using a motorized shaver.
16202458|NCT01374945|Device|Clearpath Lower GI|Clearpath device for cleaning of colon by irrigation and evacuation
16202459|NCT01374932|Device|CPAP|Continuous positive airways pressure (CPAP)
16202460|NCT01374919|Drug|ferumoxytol|IV administration of 1020 mg of ferumoxytol in 15 minutes
16202461|NCT01374906|Drug|pasireotide LAR|Pasireotide long-acting was administered as an intra-muscular depot intragluteal injection once every 28 days (±2 days). Patients were administered pasireotide long-acting 10 mg or 30 mg for four months, followed by either continuation of the starting dose, or dose up-titration (if mUFC was still >1.5xULN unless titration was precluded by safety reasons).
16202462|NCT01374906|Drug|SOM230 LAR 30 mg|starting dose of 30 mg i.m. administered once every 28 days for 4 months, followed by dose up-titration or continuation of starting dose.
16202463|NCT01374906|Drug|SOM230 LAR 10 mg|starting does of SOM230 LAR 10 mg i.m. administered once every 28 days for 4 months, followed by dose up-titration or continuation of the starting dose.
16202464|NCT01374893|Behavioral|Exercise|The intervention group will perform the multi-session per day training program
16202465|NCT01374893|Behavioral|Control|Usual care
16202466|NCT01374854|Biological|Umbilical mesenchymal stem cell (UC-MSCs) infusion|1×10^6/kg UC-MSCs is infused through pancreatic artery along with mononuclear cells by interventional therapy and another same dose of UC-MSCs is administered one week post-intervention.
16202467|NCT01374854|Drug|traditional therapy|exogenous insulin injection daily
16202468|NCT01374841|Drug|Cyclophosphamide|14.5 mg/kg, IV qd on day -6 and -5 and 50 mg/kg, IV on day +3 and +4
16202469|NCT01374841|Other|Hematopoietic Stem Cell Transplantation,|Hematopoietic Stem Cell Transplantation,
16202470|NCT01374828|Drug|Ketolorac|Ketorolac 30 mg in 10 ml saline will be injected at the incision sites at the conclusion of the procedure.
16202471|NCT01374815|Other|The Online Advocate|The Online Advocate is a Web-based social problems screening and referral tool developed at Children's Hospital.
16202472|NCT01374815|Other|The Online Advocate|The Online Advocate is a Web-based screening and referral tool for health-related social problems
16202473|NCT01374802|Drug|Darunavir|400 mg tablet for oral administration
16202474|NCT01374802|Drug|Ritonavir|tablet for oral administration
16202475|NCT01374802|Drug|BI 201335|
16202476|NCT01374789|Drug|GemCis + Panitumumab|Gemcitabine: 1250 mg/m², day 1 and 8, i.v., q3 Cisplatin: 70 mg/m², day 2, i.v., q3 Panitumumab 9 mg/kg/body weight, i.v., day 1,q3
16202477|NCT01374789|Drug|GemCis|Gemcitabine: 1250 mg/m², day 1 and 8, i.v., q3 Cisplatin: 70 mg/m², day 2, i.v., q3
16202478|NCT01374776|Drug|intravenous iron carboxymaltose|The patients will be randomized to one of the 2 treatment groups (12 patients in each group): Group I: intravenous iron carboxymaltose; Group II: intravenous placebo. Group I (intravenous iron): Ferinject will be applied via a short infusion. Patients will receive 15mg/kg of iron as iron carboxymaltose Ferinject® in 250 ml 0.9% NaCl intravenously (time of infusion 20 mins), in a single dose. The maximum dose is limited to 1000mg iron. Group II (intravenous placebo): Intravenous placebo (250 ml 0.9 % NaCl will be administrated in the same manner and time schedule than group I.
16202479|NCT01374763|Drug|Oxycodone|Prolonged-release oxycodone 10-30 mg twice daily
16202480|NCT01374763|Drug|Prolonged-release oxycodone/naloxone|Prolonged-release oxycodone/naloxone 10-30 mg twice daily
16202481|NCT01374750|Drug|Sirolimus|Sirolimus
16202482|NCT01374750|Drug|m-TOR inhibitor free|calcineurin inhibitors
16202483|NCT01374737|Drug|Dexmedetomidine|dexmedetomidine, 0.1ug/kg up or down
16202484|NCT01374724|Behavioral|Tobacco Use Ban|Airmen are restricted from use tobacco products during Basic Military Training which lasts for 8.5 weeks.
16202485|NCT01374724|Behavioral|Tailored Pamphlet|A tailored relapse prevention pamphlet inspired by Forever Free and tailored for use in the United States Air Force.
16202486|NCT01374724|Behavioral|Informational Pamphlet|"The National Cancer Institute Pamphlet Clearing the Air was provided to subjects."
16202487|NCT01374724|Behavioral|Relapse Prevention Intervention|A 15 - 30 minute relapse prevention intervention designed to increase motivation to remain tobacco free.
16202488|NCT01374711|Drug|GM-CSF|GM-CSF (4microgram/kg/day subcutaneously) on days 2, 4 and 6.
16202489|NCT01374711|Drug|IFN-Y|IFN-Y (100 microgram/day, subcutaneously) on days 2, 4 and 6.
16202490|NCT01374711|Other|E.coli endotoxin|2 ng/kg E.coli reference endotoxin 11:H 10:K negative intravenously
16202491|NCT01374698|Drug|Aspirin|Aspirin 325 mg
16202492|NCT01374672|Other|laboratory biomarker analysis|Correlative studies
16202493|NCT01374646|Behavioral|JOIN Intervention|Behavioral group treatment for overweight and obese children and teens, that focuses on decreasing energy dense foods and sedentary behaviors.
16202494|NCT01374633|Drug|1: Sevoflurane|"Mean sevoflurane infusion rate will be around 6 ml/h or 72 ml for 12 hours. Maximal infusion rate will be around 12 ml/h, or 144 ml for 12 hours. Packaging: bottle containing 250 ml of liquid sevoflurane for evaporation. Administration mode: anaesthetic conserving device for volatile anaesthetics."
16202495|NCT01374620|Drug|Paclitaxel dose escalation|"Paclitaxel will be administered intravenously over 60 minutes, at D1, D8 and D15, at a given dose.
~The Paclitaxel dose (mg/infusion) levels are as follows:
~40
~60
~70
~75
~80
~85
~90"
16202496|NCT01374620|Drug|Paclitaxel|Patients will be treated at the recommended dose in order to confirm the recommended paclitaxel dose in association with metronomic cyclophosphamide
16202497|NCT01374620|Drug|Cyclophosphamide|"D1 to D28: 50 mg x 2/day/cycle
~1 cycle = 28 days"
16202498|NCT01374620|Biological|Blood collection|At D1, D8, D15 and D21 of cycle 1 and cycle 2:2 blood samples for the correlation between clinical response and biological parameters
16202499|NCT01374581|Drug|Artemether/Lumefantrine|"Tablets containing 20 mg of Artemether and 120 mg of Lumefantrine. Each dose to be taken with high-fat food or drinks (for example milk).
~Weight in kg Number of tablet per dose Age 5 to < 15 kg 1 tablet per dose 15 to < 25 kg 2 tablets per dose 25 to < 35 kg 3 tablets per dose"
16202501|NCT01374581|Drug|Quinine + Clindamycin|"this arm consist to 7 days treatment of 60 patients with quinine tablet 125mg + clindamycin syrup as follow;
~Quinine:
~9 to < 11 kg: ½ tablets 12 to < 19 kg: 1 tablets per dose 20 to < 27 kg: 1½ tablets per dose 28 to < 35 kg: 2 tablets per dose
~Clindamycin syrup:
~10 mg/kg twice daily"
16202502|NCT01374568|Drug|sitagliptin|sitagliptin 100mg daily
16202503|NCT01374568|Other|Placebo|1 pill daily
16202504|NCT01374542|Procedure|Respiratory endoscopy|Bronchoscopy, thoracoscopy, endobronchial ultrasound
16202505|NCT01374516|Biological|Live, attenuated, dengue serotype 1, 2, 3, 4 virus|0.5 mL, Subcutaneous
16202506|NCT01374516|Biological|Placebo: (NaCl) 0.9% solution|0.5 mL, Subcutaneous
16202507|NCT01374503|Biological|ALX-0651|single or multiple (once daily for maximum 3 consecutive days) i.v. administration, 0.003-12 mg/kg
16202508|NCT01374503|Biological|Placebo|single or multiple i.v. administration
16202509|NCT01374490|Drug|Crofelemer|Crofelemer will be administered orally as 1 tablet(125 mg)BID for a total daily dose of 250mg crofelemer.
16202510|NCT01374464|Other|Interscalene brachial plexus block|"4 different administrations of levobupivicaine will be applied:
~High Volume, High Concentration = 15mls of 0.75% levobupivicaine
~High Volume, Low Concentration = 15mls of 0.5% levobupivicaine
~Low Volume, High Concentration = 5mls of 0.75% levobupivicaine
~Low Volume, Low Concentration = 5mls of 0.5% levobupivicaine"
16202511|NCT01374451|Drug|Everolimus|Everolimus was supplied as tablets of 5 mg strength, blister-packed under aluminum foil in units of 10 tablets
16202512|NCT01374451|Drug|Pasireotide LAR|Pasireotide LAR intra-muscular depot injections were supplied as a powder in vials containing 20 mg and 40 mg with ampoules containing 2 mL of vehicle (for reconstitution).
16202513|NCT01374438|Drug|MSDC-0160|MSDC-0160 150 mg capsules given once daily for 90 days
16202514|NCT01374438|Drug|Placebo|Placebo capsules given once daily for 90 days
16202515|NCT01374425|Drug|5-Fluorouracil|5-Fluorouracil 400 milligrams per meter-squared (mg/m^2) by IV bolus and subsequent 2400 mg/m^2 by IV infusion over 46 hours will be administered every 2 weeks until disease progression or unacceptable toxicity.
16202516|NCT01374425|Drug|Bevacizumab|Bevacizumab 5 milligrams per kilogram (mg/kg) of body weight via IV infusion will be administered every 2 weeks until disease progression or unacceptable toxicity. If participants are discontinued from oxaliplatin or irinotecan due to unacceptable toxicity, bevacizumab may be given in 3-week cycles with capecitabine.
16202517|NCT01374425|Drug|Irinotecan|Irinotecan 180 mg/m^2 via IV infusion over 2 hours will be administered every 2 weeks until disease progression or unacceptable toxicity.
16202518|NCT01374425|Drug|Leucovorin|Leucovorin 400 mg/m^2 or dose deemed appropriate by Investigator via IV infusion over 2 hours will be administered every 2 weeks until disease progression or unacceptable toxicity.
16202519|NCT01374425|Drug|Oxaliplatin|Oxaliplatin 85 mg/m^2 via IV infusion over 2 hours will be administered every 2 weeks until disease progression or unacceptable toxicity.
16202520|NCT01374425|Drug|Capecitabine|Capecitabine 850 or 1000 mg/m^2 may be offered in the event of unacceptable toxicity to oxaliplatin or irinotecan, to be given orally twice a day on Days 1 to 14 in 3-week cycles.
16202521|NCT01374399|Behavioral|exercise and relaxation|resistance and endurance exercise, 3-5 times per week
16202522|NCT01374386|Behavioral|Exergaming|Participants will have access to Exergaming equipment (video games that require physical activity)
16202523|NCT01374373|Biological|Epoetin alfa|Epoetin alfa 40.000-60.000 IU/week subcutaneously that will be controlled and up or down titrated every 2 weeks according to the currently approved prescription guidance for a total of 12 weeks of treatment with Co administration of oral ferrous sulfate 200mg BID and oral folic acid 5mg QD
16202524|NCT01374321|Drug|TRO40303|6 mg/kg, peripheral IV, single dose just before balloon inflation, slow bolus (35ml/min)
16202525|NCT01374321|Drug|Placebo|single dose just before balloon inflation by slow bolus (35ml/min, peripheral IV)
16202526|NCT01374308|Biological|NASVAC|NASVAC will be administered every 2 weekly intra-nasally at a dose of 100 micro grams for 5 times followed by every 2 weekly administration of 100 micro grams intra-nasally plus 100 micro grams subcutaneously.
16202527|NCT01374308|Drug|Pegylated interferon alpha 2b|Injection Pegylated interferon alpha 2b will be administered once weekly subcutaneously at a dose of 180 micro grams for 48 weeks
16202528|NCT01374295|Other|video|watch a 3 minute video
16202529|NCT01374295|Other|standard education|Receives standard verbal education from healthcare provider
16202530|NCT01374282|Drug|Cuprimine (penicillamine)|Dosage determined by the physician based on indication for treatment
16202531|NCT01374269|Other|Exercise program|Standardize the intervention programs Exercise program includes: physical agents, massage of myofascial points, stretching and strengthening exercises, cycloergometer or band aerobic exercises. 12 sessions, 3 per week.
16202532|NCT01374269|Drug|NSAID (Nonsteroidal anti-inflammatory drugs)|The second group was treated for 10 days with NSAIDs (naproxen 500 mg/d or celecoxib 200 mg/d) according to the indications and contraindications. The patients kept a journal stating whether they had taken the drug and any adverse reactions. If the pain intensity of any participant increased, acetaminophen (1.5 - 2.0 g/d) was proposed as a rescue procedure.
16202533|NCT01374230|Procedure|Total knee arthroplasty|Primary total knee arthroplasty surgery for the treatment of osteoarthritis.
16202534|NCT01374217|Drug|Tadalafil|Tadalafil will be administered at a dose of 20 mg orally daily starting with day 1 of the first cycle. Each cycle will last for 28 days
16202535|NCT01374217|Drug|Lenalidomide|Lenalidomide will be administered as it was prior to study entry.
16202536|NCT01374217|Drug|Dexamethasone|Dexamethasone will be administered as it was prior to study entry.
16202537|NCT01374217|Drug|Clarithromycin|Clarithromycin will be administered as it was prior to study entry.
16202538|NCT01374191|Drug|onabotulinum toxin type-A|1 injection of Btx-A
16202539|NCT01374191|Other|placebo|1 injection of saline solution
16202540|NCT01374191|Drug|2nd phase - onabotulinum toxin type-A|2 - 3 injections of Btx-A, specific to patient pain recurrence
16202541|NCT01374178|Drug|LY2963016|Administered subcutaneously
16202542|NCT01374178|Drug|Lantus|Administered subcutaneously
16202543|NCT01374152|Other|cognitive sensory motor training therapy|training method that emphasis on cognition/ sensation/ and motor movement together train every working day 45 minutes per day for 4 weeks.
16202544|NCT01374139|Drug|Bosutinib|5 clinical 100 mg tablets and 100 mg capsules, 500 mg, single dose, 2x2 crossover under fed condition
16202545|NCT01374139|Drug|Bosutinib|4 commercial 100 mg tablets, 400 mg, single dose, 2x2 crossover under fed/fast condition
16202546|NCT01374126|Drug|Artesunate|Artesunate alone
16202547|NCT01374126|Drug|Azithromycin + Artesunate|Combination of azithromycin + artesunate
16202548|NCT01374113|Drug|50mg safinamide|50 mg safinamide on Day 1
16202549|NCT01374100|Behavioral|Standard Exercise|The standard exercise therapy program will include 12 treatments of approximately 45 minutes duration, twice a week for a period of six weeks by the same instructor and at the same location as for Qigong therapy. This exercise program is supervised and consists of cardio-vascular and resistance training exercises. Participants are asked to refrain from practicing Qigong during this 6 week period.
16202550|NCT01374100|Behavioral|Qigong Exercise|Qigong therapy will be led by a trained Qigong instructor and will occur for 45 minutes sessions, twice a week for a period of six weeks. Qigong is a self-directed walking exercise program that involves arm movements that are coordinated with slight movements of the waist, while in a state of deep relaxation or meditation. Patients will be asked to refrain from independent resistance or cardiovascular training during this 6 week period.
16202551|NCT01374087|Drug|Triptorelin 22.5 mg|Triptorelin: A single, intramuscular injection (22.5 mg), preferably 2 months before brachytherapy.
16202552|NCT01374087|Radiation|Brachytherapy|Brachytherapy: Low or high dose rate.
16202553|NCT01374061|Device|Classical intubation|Classical intubation
16202554|NCT01374061|Device|GLIDESCOPE|GLIDESCOPE intubation
16202555|NCT01374035|Other|Quality improvement intervention|A complex intervention will be implemented within the group of GPs in the intervention group. It includes participation in defining criteria for good referral letters, information about the correlation between information in the referral letters and outcome, introduction to the guideline, and consecutive feedback on own preformance regarding content of referral letter and outcome for the patient.
16202556|NCT01374022|Other|ART Strategy|Maximum alveolar recruitment maneuver in association with PEEP titrated by the static compliance of respiratory system.
16202557|NCT01374022|Other|ARDSNet Strategy|Conventional mechanical ventilation strategy.
16202558|NCT01373996|Device|Wireless invasive blood pressure monitoring (Hybymed® Wireless IBPM System)|"The readings of invasive arterial pressure were obtained from 2 identical pressure transducers, connected to a common arterial line via a Y connector. Data was collected from one transducer via a direct cable connection and from the second transducer via wireless transmission of the signal to the patient's bedside monitor using the HMW 10 Wireless System.
~A comparison of data received by patient's bedside monitor from the two transducers was done (standard connection vs. wireless connection), as well as a comparison of data collected by the transmitter and data received by the receiver of the HMW 10 Wireless System."
16202559|NCT01373983|Drug|Ziconotide|1.25 or 2.5 mcg or 3.75 mcg i.t. according to an algorithm
16202560|NCT01373970|Drug|Placebo|Placebo, one tablet daily for 12 weeks
16202561|NCT01373970|Drug|Pantoprazole + Placebo|Pantoprazole 40 mg, one tablet daily in eight weeks followed by a blinded cross over to placebo, one tablet daily for four weeks
16202562|NCT01373931|Drug|LY2216684|Administered orally
16202563|NCT01373931|Drug|Ortho Cyclen|35 micrograms (mcg) ethinyl estradiol and 250 mcg norgestimate administered orally
16202564|NCT01373931|Drug|Placebo|Administered orally
16202565|NCT01373918|Drug|Intralipid|The subject will receive 1 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first.
16202566|NCT01373918|Drug|Intralipid|The subject will receive 3 g/kg/d of the standard intravenous fat emulsion while receiving Parenteral Nutrition until discharge from the hospital, death or 100 days of life, whichever comes first.
16202567|NCT01373905|Procedure|Recruitment maneuver|group I: Recruitment by CPAP 30 cm/H2o for 30 seconds group II: Using pressure controlled ventilation with end-inspiratory minus end-expiratory pressure of 15 cmH2O, respiratory rate of 10-15 C / min. PEEP was increased by 5 cm/ H2O every 2 minutes till Maximum of 40 cmH2O, patient was considered recruited if PaO2 of 250 mmHg was achieved. Then progressive decreases of PEEP in steps of 2 cmH2O every 2 minutes till PaO2 dropped by a 10% or more (alveolar collapsing pressure)
16202568|NCT01373905|Procedure|recruitment maneuver|recruitment as done by CPAP 30 cm/ H2o for 30 seconds or by stepwise elevation of PEEP by 5 cm/ H20 till 40 Cm/ H2o
16202569|NCT01373892|Procedure|Bariatric surgery|
16202570|NCT01373879|Biological|AdCh63 ME-TRAP, MVA ME-TRAP|AdCh63 ME-TRAP 1 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later
16202571|NCT01373879|Biological|AdCh63 ME-TRAP, MVA ME-TRAP|AdCh63 ME-TRAP 5 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later
16202572|NCT01373879|Biological|AdCh63 ME-TRAP, MVA ME-TRAP|AdCh63 ME-TRAP 1 x 10^10vp IM followed by MVA ME-TRAP 1 x 10^8 pfu IM 8 weeks later
16202573|NCT01373879|Biological|AdCh63 ME-TRAP, MVA ME-TRAP|AdCh63 ME-TRAP 1 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later
16202574|NCT01373879|Biological|HDCRV|HDCRV 1ml IM followed by HDCRV 1ml IM 8 weeks later
16202575|NCT01373879|Biological|AdCh63 ME-TRAP, MVA ME-TRAP|AdCh63 ME-TRAP 5 x 10^10vp IM followed by MVA ME-TRAP 1 x 10^8 pfu IM 8 weeks later
16202576|NCT01373879|Biological|AdCh63 ME-TRAP, MVA ME-TRAP|AdCh63 ME-TRAP 5 x 10^10vp IM followed by MVA ME-TRAP 2 x 10^8 pfu IM 8 weeks later
16202577|NCT01373879|Biological|HDCRV|HDCRV 1ml IM followed by HDCRV 1ml IM 8 weeks later
16202578|NCT01373866|Device|MagPro X100 repetitive Transcranial Magnetic Stimulation|"Target defined using both fMRI during hallucinations occurence and tractography.
~Parameters: 1 Hz/ 100% of the Motor Threshold/ 10 sessions (2/ day over 5 days)/ 1200 pulses/ session"
16202579|NCT01373866|Device|MagPro X100 repetitive Transcranial Magnetic Stimulation|Target: T3-P3 (10-20 EEG international System). Parameters: 1 Hz/ 100% of the Motor Threshold/ 10 sessions (2/ day over 5 days)/ 1200 pulses/ session
16202580|NCT01373853|Procedure|Lens Fragmentation by means of a femtosecondlaser|In Group A the anterior capsulotomy and a pre-fragmentation of the ocular lens will be performed by means of femtosecond laser surgery.
16202581|NCT01373853|Procedure|Manual Phacoemulsification|Group B acts as a control group where the capsulotomy and lens fragmentation are performed manually
16202582|NCT01373827|Device|VASERShape MC1|Use of the VASERShape MC1 device as part of routine practice
16202583|NCT01373801|Device|The HemCon GuardaCare|The HemCon GuardaCare (HemCon Medical Technologies Inc., Portland, OR) is a hemostatic dressing made of chitosan, a complex carbohydrate derived from chitin from shellfish and is designed as a hemostatic dressing, and a topical antimicrobial dressing. GuardaCare contains no pro-clotting agents, providing a safe and localized hemostatic solution and is latex free and sterile.
16202584|NCT01373801|Device|Control|Standard packing gauze roll bandage.
16202585|NCT01373775|Other|Patient charts reviewing|Reviewing chart and identifying risk factors
16202586|NCT01373762|Behavioral|Exercise Videogame Bikes|The intervention group will receive an exercise videogame bike that will be linked into their Sony Playstation 2® (Sony Computer Entertainment America Inc, Foster City, California). The Active Cycle® system reads the participant's cycling cadence which, in combination with a handlebar-mounted game controller, allows each participant to play a variety of Sony Playstation 2 and 3® videogames while exercising. The control-distraction group will receive a traditional stationary bike (i.e., same bike as the Active Cycle, but without the videogame controllers), which will be placed in front of their television. The recommended exercise training regime for both conditions will be activity of moderate intensity exercise (i.e., 60 to 75% of heart rate reserve), 3 days/week for 30 minutes/day.
16202587|NCT01373749|Drug|NO inhalation|NO inhalation was performed as the only treatment for PPHN during the whole course.
16202588|NCT01373749|Drug|NO inhalation continued with sildenafil|NO inhalation was performed as the primary treatment for PPHN in the first 48 hours, NO inhalation will be replaced by sildenafil after 48 hours of therapy.
16202589|NCT01373736|Drug|123I-meta-iodobenzylguanidine|
16202590|NCT01373723|Other|Different alternatives to improve the coverage of the populational screening programmes of cervical cancer|Cost-effectiveness analysis of 3 strategies to increase the recruitment of population screening for cervical cancer. These interventions will be compared to the current opportunistic screening strategy
16202591|NCT01373710|Drug|Trastuzumab|One injection per week during 8 weeks by lumbar puncture or Ommaya Reservoir. 4 levels of doses are expected from 30 mg to 150 mg
16202592|NCT01373697|Drug|Ibuprofen|Apply the gel at the site of pain or injury, massaging gently to promote penetration of 8 in 8 hours for 5 days. Leave the gel on the premises at least 4 hours before removal
16202593|NCT01373697|Drug|Profenid|Apply the gel on the spot of pain or injury, massaging slightly to facilitate the penetration of 8 in 8 hours during 5 days. Leave the gel on the the site at least 4 hours before removal
16202594|NCT01373684|Drug|Peginterferon alfa-2a|180 μg per week s.c. for a total duration of 48 weeks.
16202595|NCT01373684|Drug|Nucleos(t)ide analogue|All patients are all currently being treated with long-term NA treatment and will continue using these during the study. Dosage depends on which Nucleos(t)ide analogue they are using.
16202596|NCT01373671|Device|SIEMENS INSPIRATION DIGITAL BREAST TOMOSYNTHESIS (DBT) SYSTEM|DBT scan
16202597|NCT01373658|Device|Yinyi stent|subjects with Yinyi stent implantation
16202598|NCT01373645|Device|Yinyi stent|subjects with Yinyi stent implantation
16202599|NCT01373632|Device|Firebird 2 sirolimus-eluting stent|the Firebird 2 sirolimus-eluting stent is a SES with durable polymer based on Co-Cr stent platform
16202600|NCT01373632|Device|Excel sirolimus-eluting stent|the Excel sirolimus-eluting stent is a stent with biodegradable polymer (PLA) based on stainless steel (316L) stent platform
16202601|NCT01373619|Drug|Ivabradine|ivabradine titrated to 7.5 mg BID
16202602|NCT01373606|Drug|Terlipressin|
16202603|NCT01373593|Drug|lidocaine|
16202604|NCT01373593|Drug|Placebo|
16202605|NCT01373580|Device|The Raindrop Near Vision Inlay|The Raindrop Near Vision Inlay is implanted in the cornea for treatment of presbyopia
16202606|NCT01373567|Drug|TINEFCON|Two 700 mg tablets of Tinefcon in the morning and evening to be taken orally.
16202607|NCT01373554|Drug|Placebo|30mig/bid or 60mg/bid P.O
16202608|NCT01373554|Drug|Oltipraz|30mig/bid or 60mg/bid P.O
16202609|NCT01373541|Other|InFat™ based infant formula|high sn-2 palmitic acid oil based infant formula
16202610|NCT01373541|Other|Standard vegetable oil based infant formula|standard vegetable oil based infant formula
16202611|NCT01373528|Drug|Budesonide irrigation|A budesonide (1 mg) in saline (240 mL) irrigation solution is applied to the sinonasal cavities twice daily. 120 mL of the solution is applied via irrigation in the AM, and 120 mL again in the PM.
16202612|NCT01373515|Biological|DCP-001|4 bi-weekly vaccinations
16202613|NCT01373502|Device|DES Limus Carbostent|DES Limus Carbostent Carbofilm Coated Coronary Stent
16202614|NCT01373502|Device|Taxus Liberté Stent|Taxus Liberté Coronary Stent
16202615|NCT01373489|Behavioral|Technology-Assisted Case Management|The TACM intervention uses the FORA 2-in-1 Telehealth System for diabetes to link a case manager to poorly controlled diabetics in real time. Patients will be assigned the FORA 2-in-1 Telehealth System and provided glucose test strips to allow testing at least once a day. They will be asked to perform glucose testing and blood pressure measurement using the FORA system once daily. They will be asked to upload the measurements daily as soon as possible after the test is performed. The nurse case manager will have access to a secure server to which the uploaded measurements are stored in real time. Medications are titrated under supervision of a primary care and endocrinology physicians
16202616|NCT01373476|Drug|Qideng Mingmu capsule|High dosage group (4 Qideng Mingmu capsules each time): 4#, po, tid,24 weeks; Middle dosage group (2 Qideng Mingmu capsules plus 2 placebos each time):4#, po, tid,24 weeks;Low dosage group (1 Qideng Mingmu capsule plus 2 placebos each time):3#, po, tid,24 weeks.
16202617|NCT01373476|Drug|Placebo Comparator|Placebo group (4 placebos each time):4#, po, tid,24 weeks.
16202618|NCT01373463|Drug|Pemetrexed|Pemetrexed by vein every 21 days for 3 cycles
16202619|NCT01373463|Drug|Carboplatin|Carboplatin by vein Every 21 days for 3 cycles
16202620|NCT01373463|Radiation|Radiation Therapy|Radiation treatment 5 days a week for 5-6 weeks.
16202621|NCT01373463|Drug|Pemetrexed|Pemetrexed by vein every 21 days for 3 cycles
16202622|NCT01373463|Drug|Cisplatin|Cisplatin by vein every 21 days for 3 cycles
16202623|NCT01373463|Radiation|Radiation Therapy|Radiation treatment 5 days a week for 5-6 weeks.
16202624|NCT01373463|Procedure|Lobectomy|Surgery
16202625|NCT01373463|Procedure|Lobectomy|Surgery to remove a portion of the lung where the tumor is located.
16202700|NCT01372826|Drug|NKTR118 Group 2|Oral dose, 25 mg
16202626|NCT01373450|Drug|Oxyntomodulin|3.0 pmol/kg/min as an intravenous (IV) infusion in the morning of the day of graded glucose infusion (GGI) (Day 1)
16202627|NCT01373450|Drug|Liraglutide 0.6 mg|Single subcutaneous dose in the evening of the day before the GGI (Day-1)
16202628|NCT01373450|Drug|Liraglutide 1.2 mg|Single subcutaneous dose in the evening of the day before the GGI (Day-1)
16202629|NCT01373450|Drug|Placebo for Oxyntomodulin|IV infusion in the morning of the day of GGI (Day 1)
16202630|NCT01373450|Drug|Placebo for Liraglutide|Single subcutaneous dose in the evening of the day before the GGI (Day-1)
16202631|NCT01373437|Device|Ultrasonography (Sonosite )|Sonosite MICROMAXXTM with linear probe L38e/10-5 MHz
16202632|NCT01373411|Drug|ticagrelor|ticagrelor 90 mg BID for 90 days
16202633|NCT01373411|Drug|Placebo|Placebo 1 pill BID for 90 days
16202634|NCT01373398|Drug|EO9(Apaziquone)|immediate instillation after TURBT + 6 weekly instillation 4mg/mL Apaziquone
16202635|NCT01373372|Drug|Acthrel|Powder for reconstitution, 1.0 mcg/kg body weight to a maximum of 100 mcg, delivered one time via IV over one minute.
16202636|NCT01373359|Drug|Misoprostol|400 µg sublingual misoprostol
16202637|NCT01373359|Drug|Oxytocin|10 IU IM
16202638|NCT01373346|Procedure|Long limb Roux-en Y reconstruction|After radical gastrectomy, the gastrointestinal tract was reconstructed by Roux-en-Y gastrojejunostomy or esophagojejunostomy. The jejunum was divided at approximately 100-120 cm distal to the ligament of Treitz and the distal limb of the jejunum was then anastomosed along the proximal gastric greater curvature or esophagus. The jejuno-jejunostomy was performed approximately 100 to 120 cm distal from the gastrojejunal or esophagojejunal anastomosis
16202639|NCT01373333|Drug|3,4 DAP|Recommended maximum dosage: 20mg four times daily and if needed an additional 20 mg per day for a total of 100 mg per day. Drug must be kept refrigerated at all times.
16202640|NCT01373320|Behavioral|Lay health advisor interactions|"For smoking cessation: Cooper-Clayton group sessions plus motivational interviewing, both delivered by local lay health advisor.
~For all cancer screenings: lay health advisor home visits incorporating motivational interviewing and focused on decreasing participant-identified barriers to screening."
16202641|NCT01373307|Behavioral|LHA-delivered energy balance classes/activities|4-6 sessions delivered by local LHA to age-appropriate groups (i.e., children/adolescents and adults), based on We Can! And Media Smart Youth curricula.
16202642|NCT01373294|Drug|Bacille Calmette-Guerrin (BCG)|Participants will receive BCG instillations once per week for the first 6 weeks. At 3 months and 6 months, participants will receive BCG instillations once per week for three weeks.
16202643|NCT01373294|Drug|Lenalidomide|Participants may also receive capsules of lenalidomide 10 mg to swallow once per day for 7 months. The study doctor will tell participants if they will be taking lenalidomide.
16202644|NCT01373281|Biological|Live, attenuated, dengue serotype 1, 2, 3, 4 virus|0.5 mL, Subcutaneous
16202645|NCT01373281|Biological|Placebo: Sodium chloride (NaCl) 0.9%|0.5 mL, Subcutaneous
16202646|NCT01373255|Procedure|internal iliac catheterization|Women in this arm will undergo internal iliac artery catheterization prior to the cesarean delivery
16202647|NCT01373242|Drug|Liquid peanut extract (Peanut SLIT)|Liquid peanut extract will be administered under the tongue
16202648|NCT01373229|Drug|Lenalidomide + Plerixafor (+ Rituximab)|"Lenalidomide 5mg by mouth (PO) daily beginning cycle 1 day 1.
~Stage 1: increase by 2.5mg every 7 days to a maximum dose of 10mg.
~Stage 2: plerixafor will be added after 28 days of 10mg dose maintenance and white blood cell count (WBC) <100.0 x 109 / L.
~Dose cohorts of escalating subcutaneous (SC) thrice weekly plerixafor with continuous 10mg lenalidomide:
~Cohort 1: 0.24 mg/kg
~Cohort 2: 0.32 mg/kg
~Cohort 3: 0.42 mg/kg
~Cohort 4: 0.54 mg/kg
~Stage 3: Rituximab 375mg/m2 will be added on day 1 of cycles 5-12, day 1 of combination therapy for subjects with PR.
~Subjects will then continue single agent lenalidomide until disease progression."
16202649|NCT01373216|Drug|Exenatide|Perioperative continuous i.v. administration of exenatide lasting for 72 hours - 40 ng/min for initial 30 min, 20 ng/min for remaining 71.5 hours
16202650|NCT01373177|Diagnostic Test|Bayley Scales of Infant Development-II|Individually administered test, designed to evaluate the developmental functioning of infants and small children, between 1 and 42 months of age. The purpose of the test is to identify infants and children with developmental delay. BSID-II was published in 1993. BSID-II provides normative data from two scales - Mental Development Index (MDI), and Psychomotor Development Index (PDI).
16202651|NCT01373177|Diagnostic Test|Bayley Scales of Infant Development-III|Individually administered test, designed to evaluate the developmental functioning of infants and small children, between 1 and 42 months of age. The purpose of the test is to identify infants and children with developmental delay. BSID-III was released in 2006. BSID-III provides normative data from five scales - Cognitive, Language, Motor, Social-Emotional, and Adaptive.
16202652|NCT01373164|Drug|Galunisertib|Administered orally
16202653|NCT01373164|Drug|Gemcitabine|Administered intravenously
16202654|NCT01373164|Drug|Placebo|Administered orally
16202655|NCT01373151|Drug|BMS-945429 Placebo|Injection, Subcutaneous, 0 mg, Every 4 weeks, Day 1 - Week 24 only
16202656|NCT01373151|Biological|BMS-945429|Injection, Subcutaneous, 25 mg, Every 4 weeks, Day 1 - Week 24 only
16202657|NCT01373151|Biological|BMS-945429|Injection, Subcutaneous, 100 mg, Every 4 weeks, 48 weeks
16202658|NCT01373151|Biological|BMS-945429|Injection, Subcutaneous, 200 mg, Every 4 weeks, Week 25 - Week 48
16202659|NCT01373151|Biological|BMS-945429|Injection, Subcutaneous, 200 mg, Every 4 weeks, 48 weeks
16202660|NCT01373151|Drug|Methotrexate|Tablets, Oral, 15 mg, Weekly, Day 1 - Week 24 only
16202661|NCT01373151|Drug|Methotrexate|Tablets, Oral, 15 mg, Weekly, 48 weeks
16202662|NCT01373151|Drug|Methotrexate Placebo|Tablets, Oral, 0 mg, Weekly, Day 1 - Week 24 only
16202663|NCT01373151|Drug|Methotrexate|Tablets, Oral, 15 mg, Weekly, Week 25 - Week 48 only
16202664|NCT01373151|Drug|Adalimumab Placebo|Injection, Subcutaneous, 0 mg, Every 2 weeks, 48 weeks
16202665|NCT01373151|Drug|Adalimumab|Injection, Subcutaneous, 40 mg, Every 2 weeks, 48 weeks
16202666|NCT01373138|Drug|Desloratadine and pseudoephedrine|Desloratadine and pseudoephedrine 5/240 mg
16202701|NCT01372826|Drug|NKTR118 Group3|Oral dose, 25 mg
16202702|NCT01372826|Drug|NKTR118|Oral dose, 25 mg
16202703|NCT01372813|Drug|vandetanib|Daily dose 300mg/day by mouth, 28 day cycle
16202705|NCT01372787|Other|Medical Chart Review|Ancillary studies
16202667|NCT01373112|Procedure|Static Spacer|After diagnosis of infection and informed consent, patients will be taken to the operating room. After anesthetization, patients will be randomized to either an articulating spacer or a static spacer. Randomization will be performed by prepared opaque envelopes administered by a nonparticipant in the study. After a complete debridement of devitalized tissue, explantation of the infected components and any associated cement, either an articulating or static spacer will be placed. All spacers will be formed of 3 g of Vancomycin and 1 g of Tobramycin for each 40 g packet of cement. Static spacers will be hand-made to fit the femoral and tibial exposed metaphyses as a solid block with associated antibiotic cement coated tibial and femoral intramedullary rod, such that knee motion will be minimized.
16202668|NCT01373112|Procedure|Articulating Spacer|After diagnosis of infection and informed consent, patients will be taken to the operating room. After anesthetization, patients will be randomized to either an articulating spacer or a static spacer. Randomization will be performed by prepared opaque envelopes administered by a nonparticipant in the study. After a complete debridement of devitalized tissue, explantation of the infected components and any associated cement, either an articulating or static spacer will be placed. All spacers will be formed of 3 g of Vancomycin and 1 g of Tobramycin for each 40 g packet of cement. Articulating spacers will be formed of antibiotic impregnated cement using the Stage One system (Biomet, Warsaw, IN).
16202669|NCT01373099|Procedure|Implantation of a static, non-articulating cement spacer.|After diagnosis of infection and informed consent, patients will be taken to the operating room. After anesthetization, patients will be randomized to either an articulating spacer or static spacer. Randomization will be performed by prepared opaque envelopes administered by a nonparticipant in the study. After a complete debridement of devitalized tissue, explantation of infected components and any associated cement, either an articulating or static spacer will be placed. All spacers will be formed using 3.0 g of Vancomycin and 1.0 g of Tobramycin for each 40 g packet of cement. Static spacers will be hand-made with a rod of antibiotic-impregnated cement and cement beads of sufficient quantity to fill the acetabulum.
16202670|NCT01373099|Procedure|Implantation of an articulating spacer.|After diagnosis of infection and informed consent, patients will be taken to the operating room. After anesthetization, patients will be randomized to either an articulating spacer or static spacer. Randomization will be performed by prepared opaque envelopes administered by a nonparticipant in the study. After a complete debridement of devitalized tissue, explantation of infected components and any associated cement, either an articulating or static spacer will be placed. All spacers will be formed using 3.0 g of Vancomycin and 1.0 g of Tobramycin for each 40 g packet of cement. Articulating spacers will be formed of antibiotic-impregnated cement using the Stage One system (Biomet, Warsaw, IN) sized to fit the endosteal and acetabular bone defect.
16202671|NCT01373086|Drug|LFF269|
16202672|NCT01373086|Drug|Eplerenone|
16202673|NCT01373086|Drug|Placebo|
16202674|NCT01373073|Other|Experimental human milk fortifier|Human milk fortifier to be added to human milk feedings
16202675|NCT01373073|Other|Control human milk fortifier|Control human milk fortifier to be added to human milk
16202676|NCT01373060|Drug|ASP1941|oral
16202677|NCT01373060|Drug|Placebo|oral
16202678|NCT01373047|Biological|anti-CEA 2nd generation designer T cells|Three infusions of gene-modified T cells over the course of 6 weeks into the hepatic artery via a percutaneous approach.
16202679|NCT01373034|Dietary Supplement|Soy Dietary Fiber|Soy Dietary Fiber, Once a day, before meal, 1 pack(20g), per oral with water 90mL
16202680|NCT01373034|Dietary Supplement|Rice powder|Rice powder, Once a day, before meal, 1 pack(20g), per oral with water 90mL
16202681|NCT01373021|Drug|Fentanyl|Fentanyl 2500mcg+NS50ml
16202682|NCT01373021|Drug|Dexmedetomidine|Fentanyl 2500mcg+Dexmedetomidine 500mcg + NS 45ml
16202683|NCT01373008|Drug|Inhaled extra-fine hydrofluoalkane-beclomethasone (QVAR)|Infants will be randomized for Inhaled QVAR 100 microgram or placebo twice daily with spontaneous tidal breathing for 30 seconds via aerochamber with face mask for the study period.
16202684|NCT01372995|Drug|Enteral Vitamin D3 50,000 IU|Enteral Vitamin D3 50,000IU x 5 days (total dose 250,000IU)
16202685|NCT01372995|Drug|Enteral Vitamin D3 100,000IU|Enteral Vitamin D3 100,000IU over 5 days (total 500,000IU)
16202686|NCT01372995|Other|Inactive substance|Inactive substance given enterally for 5 days.
16202687|NCT01372982|Drug|Letrozole|Letrozole Tablets 2.5 mg of Dr.Reddy's Laboratories Limited
16202688|NCT01372969|Drug|Cx601|Suspension of adult expanded allogenic adipose-derived stem cells (eASCs) at a doses of 20 million cells and 40 million cells.
16202689|NCT01372943|Biological|"synthetic stool or pure cultures of probiotic intestinal bacteria"|"synthetic stool or pure cultures of probiotic intestinal bacteria from healthy donor stool that can be used as an enema to replace the use of stool transplant, for treatment of recurrent and refractory CDI"
16202690|NCT01372930|Drug|Etanercept|Etanercept 25mg in 1ml(subcutaneous injection)at 2h and 72h after PCI
16202691|NCT01372930|Drug|saline|saline 1ml(subcutaneous injection) at 2h and 72h after PCI
16202692|NCT01372904|Drug|Dexamethasone Phosphate|"0.7ml of Dexamethasone Phosphate 10mg/ml would be injected unilaterally to the middle ear using 25 gauge spinal needle.
~The trans-tympanic membrane injection would take place at the posterior inferior quadrant of the ear drum facing the round window niche. The patient would be instructed to lie down for 20 minutes after the injection with the treated side up and to avoid swallowing or coughing. Intratympanic Dexamethasone would be delivered immediately prior to each cisplatin treatment as maximal level."
16202693|NCT01372878|Device|PillCam® COLON 2 procedure|Subjects will undergo a PillCam® COLON 2 procedure which includes ingestion of the PillCam® COLON 2 capsule. PillCam® COLON 2 is a disposable, ingestible capsule that takes video images throughout the digestive system.
16202694|NCT01372878|Procedure|Colonoscopy|"Subjects will undergo standard Colonoscopy procedure 4-6 weeks after PillCam® COLON 2 procedure.
~Standard colonoscopy involves placement of a standard endoscope (a thin, flexible plastic tube) into the anus and into the colon, a tiny camera in the endoscope allows the study doctor to see the surface of the colon."
16202695|NCT01372865|Drug|Mometasone furoate|
16202696|NCT01372865|Drug|Mometasone furoate|
16202697|NCT01372839|Drug|Atorvastatin|Atorvastatin 80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care
16202698|NCT01372839|Drug|Statin|Usual care, but statin dose should not be higher than that described in exclusion criteria
16202699|NCT01372826|Drug|NKTR118 Group1|Oral dose, 25 mg
16202709|NCT01372774|Radiation|whole-brain radiation therapy|Undergo radiotherapy (RT)
16202710|NCT01372761|Drug|ZGN-433|Subjects will receive placebo or ZGN-433 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.
16202711|NCT01372761|Drug|Normal Saline|Subjects will receive placebo or ZGN-433 twice-weekly over a 4-week treatment period for a total of 8 doses. A range of doses will be evaluated.
16202712|NCT01372748|Other|Standard CPR|30:2 CPR consists of 3 cycles of standard CPR with each cycle consisting of 30 chest compressions with a pause for 2 ventilations at a compression:ventilation ratio of 30:2. CCC consists of a series of three cycles of continuous chest compressions without pauses for ventilation. In either group, each cycle will be followed by rhythm analysis until three cycles are completed or restoration of spontaneous circulation (ROSC), whichever occurs first.
16202713|NCT01372748|Other|Continuous chest compressions|Continuous chest compressions during the first 6 minutes of the resuscitation.
16202714|NCT01372735|Radiation|neoadjuvant short course IMRT|neoadjuvant short course intensity-modulated radiotherapy, single dose 5 Gy, total dose 25 Gy (5x5 schedule) to primary tumor and regional lymph nodes
16202715|NCT01372735|Radiation|IORT|intraoperative radiation therapy during resection, 15 Gy (to 90% isodose) to tumor bed
16202716|NCT01372722|Device|DBS Activa PC systems Medtronic|130Hz, 90us pulsewidth, 4V Amplitude
16202717|NCT01372722|Device|DBS, Activa PC systems Medtronic|30Hz, 90us pulsewidth, 4V Amplitude
16202718|NCT01372709|Device|Ovation™ or Ovation Prime™ Abdominal Stent Graft System|Single occurrence permanent implant of AAA device.
16202719|NCT01372696|Other|Sample of polyp|A small sample of the colonic polyp will be obtained for molecular testing. The remaining polyp will be sent for regular histological testing
16202720|NCT01372683|Other|Dietary Intervention|Comparison of oat based breakfast cereals
16202721|NCT01372670|Drug|Hydroxyzine|"Study medications (hydroxyzine/placebo) will be dosed based on participant's weight. Dosing will be according to the following body weight ranges:
~15-29 Kg 10 mg TID 30-44 Kg 20 mg TID
~≥ 45 Kg 30 mg TID"
16202722|NCT01372670|Drug|hydroxyzine HCL|hydroxyzine HCL dosed on weight given 3x per day
16202723|NCT01372670|Other|Placebo|Placebo given 3 times per day
16202724|NCT01372657|Other|biometry calculation|
16202725|NCT01372644|Drug|SOM 230 / Pasireotide|
16202726|NCT01372631|Device|miniature spectral imaging system|Use of miniature spectral imaging system
16202727|NCT01372631|Device|Bench-top optical spectrometer|Use of bench-top optical spectrometer
16202728|NCT01372631|Device|High resolution microendoscope|Use of high resolution microendoscope
16202729|NCT01372618|Drug|SOM 230 / Pasireotide|SOM230/Pasireotide is a multi-receptor targeted somatostatin analogue. In this trial, 600 mcg of SOM230/Pasireotide are taken twice daily subcutaneously.
16202730|NCT01372605|Other|Measurement-Based Care collaborative depression management|Depression Care Manager collects metrics on depressive severity and side effects and provides decision support regarding antidepressant initiation and modification to HIV providers who prescribe medications
16202731|NCT01372605|Other|Enhanced Usual Care|
16202732|NCT01372592|Procedure|Surgery|Patients will receive standard of care surgical treatment dependent on his/her spinal condition.
16202733|NCT01372579|Drug|eribulin mesylate|Given IV
16202734|NCT01372579|Drug|carboplatin|Given IV
16202735|NCT01372579|Procedure|biopsy|Correlative studies
16202736|NCT01372566|Device|Harvest PRP Separation System|Platelet-rich plasma (PRP) is a blood-derived therapy that consists of platelets and growth factors. PRP can be formed by drawing blood from a vein and spinning it at a high speed in a specialized device called a centrifuge.
16202737|NCT01372566|Other|Sterile Saline injection|Sterile Saline will be injected multiple times in a different area of the arm (Part 1) or on the opposite side of the face from where the platelet rich plasma is injected.
16202738|NCT01372540|Drug|Carfilzomib|Given IV
16202739|NCT01372540|Drug|Filanesib|Given IV
16202740|NCT01372540|Other|Laboratory Biomarker Analysis|Correlative studies
16202741|NCT01372527|Other|TopCare: Use of provider knowledge vs. automated system|We will be evaluating the system in practices where providers are involved in determining to contact a patient, including the most appropriate outreach method, compared with practices where the system is fully automated without provider input.
16202742|NCT01372501|Device|Endobarrier Liner|Medical device placed endoscopically in the duodenum
16202743|NCT01372488|Procedure|Suture self removal|Suture self removal
16202744|NCT01372488|Procedure|Suture removal by family doctor or clinic|As above
16202745|NCT01372475|Device|Hymovis Intra-articular Injection|Hymovis Intra-articular injection
16202746|NCT01372475|Procedure|Phosphate Buffered Saline Injection|Placebo Intra-articular injection
16202747|NCT01372462|Device|NIOV - Room Air|Noninvasive ventilation with device powered by compressed room air.
16202748|NCT01372462|Device|NIOV - Oxygen|Noninvasive ventilation with device powered by compressed medical (100%) oxygen.
16202749|NCT01372462|Device|Nasal Cannula Oxygen|Supplemental oxygen delivered using a standard nasal cannula connected to 100% medical oxygen.
16202750|NCT01372449|Drug|Memantine|Memantine will be initiated at 3 mg. The dose will be increased every week by 3 mg for a maximum of 12mg for subjects weighing ≥ 60kg, 9mg for subjects weighing ≥ 40 kg but <60 kg, and 6 mg for subjects weighing ≥ 20 kg but < 40kg.
16202751|NCT01372449|Drug|Placebo|
16202752|NCT01372423|Drug|Lubiprostone|24 mcg capsules
16202753|NCT01372423|Drug|Placebo|24 mcg capsules
16202754|NCT01372410|Drug|GSK573719|125 mcg once daily
16202755|NCT01372410|Drug|GSK573719|62.5 mcg once daily
16202756|NCT01372410|Drug|GSK573719|31.25 mcg once daily
16202757|NCT01372410|Drug|GSK573719|15.6 mcg once daily
16202758|NCT01372410|Drug|GSK573719|31.25 mcg twice daily
16202759|NCT01372410|Drug|GSK573719|15.6 mcg twice daily
16202760|NCT01372410|Drug|Tiotropium|18 mcg once daily
16202761|NCT01372410|Drug|Placebo|once or twice daily
16202762|NCT01372384|Drug|erlotinib [Tarceva]|150 mg orally daily
16202763|NCT01372371|Biological|Vancomycin|1 pre-operative dose of intravenous Cefuroxime (1.5 gm) and 2 post-operative doses of Cefuroxime (750 mg) + 500 mg of vancomycin instilled on surgical site before closure
16202764|NCT01372371|Biological|Vancomycin and Gentamycin|1 pre-operative dose of intravenous Cefuroxime (1.5 gm) and 2 post-operative doses of Cefuroxime (750 mg) and 500 mg of vancomycin powder on surgical site before closure with gentamycin bone cement for joint replacement cases.
16202765|NCT01372371|Biological|Cefuroxime|1 pre-operative dose of Cefuroxime (1.5 gm) and 2 post-operative doses of Cefuroxime (750 mg)
16202766|NCT01372358|Drug|CIPRO®XR|Ciprofloxacin 1000 mg Tablets Dr. Reddy's Laboratories Limited
16202767|NCT01372345|Drug|CIPRO®XR|Ciprofloxacin 1000 mg Tablets Dr. Reddy's Laboratories Limited
16202768|NCT01372306|Drug|Reminyl|Galantamine Hydrobromide Tablets of Dr. Reddy's Laboratories Limited
16202769|NCT01372293|Drug|oral contraceptive pill|ethinyl oestradiol 20ug plus gestodene 75ug during 6 cycles
16202770|NCT01372280|Drug|Reminyl|Galantamine Hydrobromide Tablets 4 mg
16202771|NCT01372267|Behavioral|Psychoeducation for substance abuse|This active control provides detailed educational information about substance use and chronic pain to those enrolled.
16202772|NCT01372267|Behavioral|CBT for pain in Substance abuse|The therapeutic intervention group is designed to provide beneficial coping strategies that are helpful in dealing with both substance use and pain.
16202773|NCT01372254|Behavioral|Standard Treatment|Participants will receive a standard smoking cessation treatment in individual format. Treatment will be delivered in five, 90-minute individual sessions, and with two booster sessions assessed scheduled 2 and 4 weeks post quit. Participants will also receive 8 weeks of the transdermal nicotine patch.
16202774|NCT01372254|Behavioral|BAD-AS|The Behavioral Activation for Drug Abusing Smokers (BA-DAS) treatment protocol will incorporate elements of the ST along with behavioral activation strategies, modified for smoking. Treatment will consist of five, 90-minute individual sessions, and with two booster sessions scheduled 2 and 4 weeks post quit. Participants will also receive 8 weeks of the transdermal nicotine patch.
16202775|NCT01372254|Drug|Transdermal Nicotine Patch|8 weeks of the Transdermal Nicotine Patch Nicoderm CQ at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to the participant's initial nicotine level. Participants in both intervention arms will receive transdermal nicotine patch.
16202776|NCT01372241|Behavioral|Lay health advisor visits and newsletter|The focus of the intervention was on reducing participants' self-identified barriers to obtaining Pap tests.
16202777|NCT01372228|Biological|hematopoietic stem cell infusion|Enriched hematopoetic stem cell infusion
16202778|NCT01372202|Drug|Paclitaxel|Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
16202779|NCT01372202|Drug|Cisplatin|"Paclitaxel and cisplatin:
~Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29.
~Cisplatin 30 mg/m² days 1, 8, 15, 22, 29.
~Cisplatin and 5-fluorouracil:
~5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1- 4 and 29 - 32.
~Cisplatin 75 mg/m² days 1, 29."
16202780|NCT01372202|Drug|Oxaliplatin|Oxaliplatin 85 mg/m2 days 1, 15, 29.
16202781|NCT01372202|Drug|5-Fluorouracil|"Oxaliplatin and 5-fluorouracil:
~Oxaliplatin 85 mg/m2 days 1, 15, 29.
~5-Fluorouracil 180 mg/m2 prolonged infusion starting day 1 of radiation and completing on the final day of radiation (up to 40 days)
~Cisplatin and 5-fluorouracil:
~5-Fluorouracil 1000 mg/m2 per day over 24 hours days 1-4 and 29-32.
~Cisplatin 75 mg/m² days 1, 29."
16202782|NCT01372202|Radiation|Radiotherapy|Patients will be treated 5 days/week at 1.8 Gy/day to a total dose of 45Gy.
16202783|NCT01372202|Procedure|Esophagectomy|The type of resection (Ivor-Lewis, Transhiatal, etc.) will be left to the discretion of the operating surgeon. Resection will be completed between 5 and 8 weeks starting from the completion of chemotherapy and radiation (days 36 - 56).
16202784|NCT01372176|Other|Early Goal-Directed Nutrition|"Initiation of early supplementary parenteral nutrition (≤ 24 hours of admission).
~Measurement of requirements (indirect calorimetry, 24-hour urinary urea) leading to patient-specific, individualised and goal-directed nutritional therapy.
~Intervention goal: delivering 100% of patient-specific requirements, measured or calculated throughout entire admission (EN+PN)."
16202785|NCT01372176|Other|ASPEN-guidelines|EN will be the preferred route of nutrition, and will be initiated within the first 24 hours of ICU admission, in accordance with best evidence. The amount is gradually increased over the first days of admission as tolerated by the patient (assessed from gastric aspirates). If EN fails to reach calculated goals at day 7, supplementary PN will be initiated at admission day 8 to reach goals. Protein and energy goals will be calculated as 25 kcal/kg/day and 1.2 g protein/kg/day.
16202786|NCT01372163|Drug|PF-05190457 or Placebo|Twice daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast and dinner in healthy volunteers.
16202787|NCT01372163|Drug|PF-05190457 or Placebo|Twice daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast and dinner in healthy volunteers.
16202788|NCT01372163|Drug|PF-05190457 or Placebo|Twice daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast and dinner in healthy volunteers.
16202789|NCT01372163|Drug|PF-05190457 or Placebo|Twice daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast and dinner in healthy volunteers.
16202790|NCT01372163|Drug|PF-05190457 or Placebo|Once daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast in healthy volunteers.
16202791|NCT01372163|Drug|PF-05190457 or Placebo|Once daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast in healthy volunteers.
16202792|NCT01372163|Drug|PF-05190457 or Placebo|Once (or twice) daily oral doses of PF-05190457 or placebo is administered as a suspension for 14 days immediately before breakfast (and dinner if twice) in Type 2 Diabetic patients.
16202793|NCT01372150|Drug|desvenlafaxine succinate sustained release|Subjects randomized to DVS SR group receive 25, 35 or 50 mg/day based on subject weight at the Baseline visit. DVS SR provided as oral tablets.
16202794|NCT01372150|Drug|fluoxetine|Subjects randomized to the fluoxetine group receive 20 mg/day. Fluoxetine provided as oral capsules
16202795|NCT01372150|Drug|placebo|Subjects randomized to the placebo group receive corresponding placebo tablets and/capsules
16202796|NCT01372137|Drug|NOX-H94|Dosage form: NOX-H94 25 mg (oligonucleotide basis) Solution for Injection Strength: 14.6 mg NOX-H94 / mL Dose: 0.3 - 4.8 mg/kg single dose Route: IV infusion over 15 minutes / SC administration
16202797|NCT01372137|Other|Glucose 5%|Placebo
16202798|NCT01372124|Drug|NOX-E36|All subjects included in this study will receive the same dose of NOX E36. In previous clinical trials, single intravenous doses of NOX E36 up to 2 mg/kg body weight and single subcutaneous doses of up to 0.5 mg/kg body weight appeared to be safe and well tolerated in healthy volunteers. Pharmacokinetic analyses have shown dose linearity
16202799|NCT01372111|Drug|Cisplatin|Cisplatin 35 mg/m2 IV weekly during weeks 1 through 6 of IMRT.
16202800|NCT01372111|Radiation|Elective Nodal Irradiation (ENI)|Low risk planning target volume (PTV) of 36 Gy at 2 Gy per fraction daily to bilateral, uninvolved neck nodal regions at risk for harboring microscopic cancer. High risk PTV will receive 70 Gy.
16202801|NCT01372098|Behavioral|NFP + IPV intervention|The intervention focuses on helping women stay safe in a relationship. Strategies for overcoming barriers to using and accessing community resources and services, and community agency interventions for women exposed to IPV is built into the intervention.
16202802|NCT01372085|Drug|LY2584702 Reference Formulation|Administered orally
16202803|NCT01372085|Drug|LY2584702 Test Formulation|Administered orally
16202804|NCT01372085|Drug|Placebo|Administered orally
16202805|NCT01372072|Device|non-invasive ventilation heated humidification (Fisher-Paykel MR810 and MR850 humidifiers)|Heated humidification (Fisher-Paykel MR810 and MR850 humidifiers)
16202806|NCT01372059|Other|RGRM|RGRM is multi-sensory method. The group including 6-8 participants is headed by a certified therapist of the method using a unique note system. The Note system is the combined body of body symbols in red and blue, with the audio codes and movements and be assembled in countless combinations to stimulate different parts of the brain. The movements are exercised by the hands tapping on the knees and feet stamping on the floor without the need for tools other than the body. The RGRM is developed to stimulate mobility, reading and speech, rhythm-esteem, body image, balance, memory, coordination, motor skills, concentration, perseverance and social skills. The group will have two sessions per week during 12 weeks.
16202807|NCT01372059|Other|Therapeutic riding|The horses walk provides sensory input through movement, which is variable, rhythmic, and repetitive. The many textures, sounds, sights, movement experiences of working around a horse provide an enriched sensory environment. The participants gain from the physical benefits of being on a moving horse and are socially and emotionally stimulated by interacting with a horse and the rest of the group. The intervention is headed by educated therapists (occupational therapist and physical therapist), in conjunction with experienced horse handler and specially trained therapy horses. The treatment is held in group format (4-6 participants) twice per week in 12 weeks which runs in sessions where two participants ride at the same time.
16202808|NCT01372059|Other|Receives no intervention|Receives no intervention and acts as a control group in the analyses but will receive rhythm and music therapy after one year, when the long-term follow-up is completed.
16202809|NCT01372046|Behavioral|Booster Sessions|Provides onsite booster sessions for one year to the group after participating in standard care
16202810|NCT01372046|Behavioral|Training|memorandums, staff meetings
16202811|NCT01372033|Behavioral|Cognitive Behavioral Therapy|18 sessions of CBT, twice weekly
16202812|NCT01372033|Behavioral|Cognitive Behavioral Therapy|18 sessions with goals groups drug testing
16202813|NCT01372020|Other|neuromuscular electrical stimulation|The application technique used will be bipolar, with electrodes of the type metal-tipped pen. The electrodes will be placed at the outer edges of the ulcer, on opposite sides of the same and the estimated time of 1 minute at each point. All the edge of the ulcer will be bypassed, thereby separating the injections every 1 cm, returning to the starting point at the end of the application. To ensure that the entire edge of the ulcer to receive the stimulation, the end points of the application, the application will be made for another minute sliding the pen around the whole edge. Thus the application time will be directly proportional to the ulcer area. The subjects will be received 10 applications, three times a week for a period of 4 weeks.
16202814|NCT01372007|Drug|Lanreotide Autogel 120mg|Drain fluid will be checked for hematocrit daily post-surgery. Once hematocrit levels of the drain fluid are <10%, study medication (0.246mg lanreotide base/mg solution) will be administered. After administration the volume of the drain fluid will be measured every 12 hours for at least 5 days. A sample of the drain fluid will be collected every 24 hours for at least 5 days and frozen at -70°C for total protein content, sodium and chloride analysis afterwards.
16202815|NCT01372007|Drug|Placebo|Drain fluid will be checked for hematocrit daily post-surgery. Once hematocrit levels of the drain fluid are <10%, placebo (Sodiumchloride 0,9% 1 ampoule) will be administered. After administration the volume of the drain fluid will be measured every 12 hours for at least 5 days. A sample of the drain fluid will be collected every 24 hours for at least 5 days and frozen at -70°C for total protein content, sodium and chloride analysis afterwards.
16202816|NCT01371994|Drug|solifenacin succinate|oral
16202817|NCT01371994|Drug|Placebo|oral
16202818|NCT01371981|Drug|Asparaginase|Given IM
16202819|NCT01371981|Drug|Bortezomib|Given IV
16202820|NCT01371981|Drug|Cytarabine|Given IT or IV
16202821|NCT01371981|Drug|Daunorubicin Hydrochloride|Given IV
16202822|NCT01371981|Drug|Etoposide|Given IV
16202823|NCT01371981|Other|Laboratory Biomarker Analysis|Correlative studies
16202824|NCT01371981|Drug|Mitoxantrone Hydrochloride|Given IV
16202825|NCT01371981|Other|Pharmacological Study|Correlative studies
16202826|NCT01371981|Other|Quality-of-Life Assessment|Ancillary studies
16202827|NCT01371981|Other|Questionnaire Administration|Ancillary studies
16202828|NCT01371981|Drug|Sorafenib Tosylate|Given PO
16202829|NCT01371968|Drug|alfentanil|Alfentanil is administered intravenously at the end of surgery.
16202830|NCT01371877|Drug|Vitamin D3|Vitamin D 4000 IU per day for 3 months
16202831|NCT01371877|Drug|Vitamin D3|Vitamin D 600 IU per day
16202832|NCT01371851|Drug|Doxazosin extended release|initially maintained on doxazosin extended release 4 mg once a day for 7 days, then the dose is increased to 8 mg once per day for the duration of the trial.
16202833|NCT01371838|Drug|Ceftaroline|Two consecutive infusions q12h for 5 to 7 days
16202834|NCT01371838|Drug|Ceftriaxone|One dose infusion followed by IV saline placebo infused q24h for 5 to 7 days plus two consecutive saline placebo infusion q24h.
16202886|NCT01371552|Device|narafilcon A contact lenses|Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.
16202835|NCT01371825|Drug|Sebelipase alfa (SBC-102)|Sebelipase alfa is a recombinant human lysosomal acid lipase enzyme. The investigational medicinal product is an enzyme replacement therapy intended for treatment of participants with LAL Deficiency. Dosing occurred qw for up to 5 years.
16202836|NCT01371812|Drug|GSK2239633|Drug will be orally administered at the doses and time points detailed in the 'arms' section.
16202837|NCT01371812|Drug|Placebo|Placebo will be orally administered to 4 subjects in each treatment period of each cohort.
16202838|NCT01371799|Drug|Drug|Placebo
16202839|NCT01371799|Drug|Drug|4mg and 8mg Study drug
16202840|NCT01371786|Drug|ciclesonide nasal aerosol|A radiolabeled solution of ciclesonide nasal aerosol supplied in a 37 μg/actuation canister
16202841|NCT01371786|Drug|mometasone Aqueous (AQ) nasal spray|A radiolabeled suspension of mometasone Aqueous (AQ) nasal spray supplied in a 50 μg/actuation bottle
16202842|NCT01371773|Procedure|repositioning method for left-sided double lumen tubes|When a left-sided double lumen tube were placed in right mainstem bronchus, after withdrawing the tube into mid-trachea, it was re-advanced with patient's head turned right and counterclockwise rotation of the tube.
16202843|NCT01371760|Procedure|Venous PTA|PTA of the internal jugular and/or azygous vein
16202844|NCT01371760|Other|Catheter Venography|The patients will undergo catheter venography but not PTA
16202845|NCT01371747|Drug|patiromer|Cohorts 1, 2 and 3 - Patiromer starting dose: 8.4 g/day, orally, as a divided dose, twice daily. The dose of patiromer could be titrated based on participant's serum potassium response (Stratum 1)
16202846|NCT01371747|Drug|patiromer|Cohorts 1, 2 and 3 - Patiromer starting dose: 16.8 g/day, orally, as a divided dose, twice daily. The dose of patiromer could be titrated based on participant's serum potassium response. (Stratum 2)
16202847|NCT01371747|Drug|patiromer|Cohorts 1, 2 and 3 - Patiromer starting dose: 16.8 g/day, orally, as a divided dose, twice daily. The dose of patiromer could be titrated based on participant's serum potassium response (Stratum 1)
16202848|NCT01371747|Drug|patiromer|Cohorts 1, 2 and 3 - Patiromer starting dose: 25.2 g/day, orally, as a divided dose, twice daily. The dose of patiromer could be titrated based on participant's serum potassium response (Stratum 1)
16202849|NCT01371747|Drug|patiromer|Cohorts 1, 2 and 3 - Patiromer starting dose: 25.2 g/day, orally, as a divided dose, twice daily. The dose of patiromer could be titrated based on participant's serum potassium response. (Stratum 2)
16202850|NCT01371747|Drug|patiromer|Cohorts 1, 2 and 3 - Patiromer starting dose: 33.6 g/day, orally, as a divided dose, twice daily. The dose of patiromer could be titrated based on participant's serum potassium response. (Stratum 2)
16202851|NCT01371747|Drug|losartan|losartan dose: 100 mg/d, oral, once daily (initiated during Run-In Period; Cohort 1)
16202852|NCT01371747|Drug|spironolactone|Spironolactone dose: 25 mg/d or up to 50 mg/d, oral, once daily (initiated during Run-In Period; Cohort 2)
16202853|NCT01371734|Drug|Desvenlafaxine Succinate Sustained-Release|Subjects randomized to DVS SR treatment arm will receive 25, 35, or 50 mg/day based on subject weight at the Baseline visit.
16202854|NCT01371734|Drug|Desvenlafaxine Succinate Sustained-Release|Subjects randomized to DVS SR treatment arm will receive 20, 25, or 35 mg/day based on subject weight at the Baseline visit.
16202855|NCT01371734|Drug|Placebo|Subjects randomized to the Placebo treatment arm will receive placebo tablets
16202856|NCT01371721|Drug|DVS SR|Subjects will receive a flexible-dose of 20, 25, 35 or 50 mg/day as prescribed by the investigator.
16202857|NCT01371708|Drug|DVS SR|Subjects will receive a flexible-dose of 20, 25, 35, or 50 mg/day as prescribed by the investigator
16202858|NCT01371682|Drug|Ropinirole XL|Ropinirole XL manufactured at Crawley will be compared to that manufactued at Aranda.
16202859|NCT01371656|Drug|levofloxacin|Given PO or IV
16202860|NCT01371643|Drug|Octreotide LAR|
16202861|NCT01371643|Procedure|transsphenoidal surgery|
16202862|NCT01371630|Biological|Blinatumomab|Given CIVI
16202863|NCT01371630|Drug|Cyclophosphamide|Given IV
16202864|NCT01371630|Drug|Cytarabine|Given IT and IV
16202865|NCT01371630|Biological|Inotuzumab Ozogamicin|Given IV
16202866|NCT01371630|Other|Laboratory Biomarker Analysis|Correlative studies
16202867|NCT01371630|Drug|Mercaptopurine|Given PO
16202868|NCT01371630|Drug|Methotrexate|Given IT, IV, and PO
16202869|NCT01371630|Drug|Prednisone|Given PO
16202870|NCT01371630|Biological|Rituximab|Given IV
16202871|NCT01371630|Drug|Vincristine|Given IV
16202872|NCT01371617|Drug|IPI-926|Single Arm study of oral IPI-926 at 160 mg, 130 mg or 110 mg daily, until progressive disease or intolerability to study treatments or withdrawal of ICF
16202873|NCT01371604|Drug|IDX184|IDX184 50 mg tablet administered orally
16202874|NCT01371604|Biological|Peginterferon alfa-2a (Peg-IFN)|Peginterferon alfa-2 180 microgram prefilled syringe administered subcutaneously once weekly
16202875|NCT01371604|Drug|Ribavirin (RBV)|Ribavirin 200 mg tablets administered orally as a divided dose twice daily. Total daily dose to administered will be 1000 or 1200 mg based on body weight.
16202876|NCT01371604|Drug|Placebo|Matching placebo to IDX184 50 mg tablet administered orally
16202877|NCT01371591|Device|Pill Cam, clinical evaluation|The Pill Cam, VCE, will be used for clinical decisions. VCE will be read by site PI or co-PI and by site GI doctor.
16202878|NCT01371591|Device|Pill Cam, archived|VCE will not be used for clinical decisions. VCE video will be archived and read at a later date.
16202879|NCT01371578|Drug|GS-5885 tablet|30 mg active tablet
16202880|NCT01371578|Drug|GS-9451 tablet|two active 100 mg tablets
16202881|NCT01371578|Biological|peginterferon alfa-2a|peginterferon alfa-2a (solution for injection) 180 µg/week
16202882|NCT01371578|Drug|ribavirin tablet|ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID); tablet
16202883|NCT01371565|Drug|Mifepristone|mifepristone at doses from 300mg/day up to 1200mg/day
16202884|NCT01371552|Device|delefilcon A contact lens|Investigational, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1 and one week in Part 2.
16202885|NCT01371552|Device|filcon II 3 contact lenses|Commercially marketed, silicone hydrogel, single vision contact lens worn on a daily disposable basis for 3 days in Part 1.
16202933|NCT01371162|Drug|RO5428029|Multiple ascending doses
16202887|NCT01371539|Device|Lotrafilcon B contact lens|Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use.
16202888|NCT01371539|Device|Comfilcon A contact lens|Commercially marketed (France), silicone hydrogel, multifocal contact lens for daily wear use.
16202889|NCT01371526|Drug|depot tetracosactide|1mg, 3x weekly by sc injection
16202890|NCT01371513|Other|continuous screening|practice patterns for screening prostate cancer
16202891|NCT01371487|Drug|GSK1120212|Oral/once-daily single doses on Day 1 of Periods 1 and 2
16202892|NCT01371474|Drug|Paroxetine|
16202893|NCT01371461|Drug|Paroxetine|
16202894|NCT01371448|Drug|Paroxetine|
16202895|NCT01371435|Drug|Paroxetine|
16202896|NCT01371422|Other|Paravertebral Block (PVB)|"The T10, T11 and T12 paravertebral spaces on the operative side will be identified with ultrasound in all patients (Sonosite MicroMax, 2-5 MHz curvilinear probe).
~In the PVB group, a 90mm 22g Tuohy needle will be inserted in-plane with the live ultrasound image over the transverse process at each of these levels and 5 mL of 0.5% ropivacaine will be injected at each level."
16202897|NCT01371422|Other|Saline|Ultrasonography and local infiltration of saline will only be performed
16202898|NCT01371409|Other|continuous theta burst stimulation|80% active motor threshold, 600 pulses
16202899|NCT01371396|Other|Low-fat diet|The subject will consume a diet that is calorically restricted to cause at least a 6% body weight loss over 4 months. Fat will make up less than 30% of dietary energy.
16202900|NCT01371396|Other|Low-carbohydrate diet|The diet will be restricted in energy to cause at least a 6% loss of body weight over a 4 month period. Carbohydrate will provide less than 40% of total dietary energy.
16202901|NCT01371383|Dietary Supplement|Omega-3 fatty acids|1.6~2.8 gram/day (5 capsules)
16202902|NCT01371383|Dietary Supplement|placebo|5 gram/day (5 capsules)
16202903|NCT01371370|Other|Resistance exercise training|The low intensity resistance exercise training intervention consists of lower-body resistance exercise (machines) 3 times per wk for 12 wk. Two sets the first 2 wk and 3 sets the rest of the intervention, at 40% of the estimated 1 repetition maximum, for 17 to 23 repetitions, with 1 minute of rest in between sets.
16202904|NCT01371370|Other|Hypocaloric diet|The hypocaloric diet intervention consists of 12 wk of the standard Nutrisystem foods plan complemented by fresh produce and dairy. Subjects consume breakfast, lunch, dinner, and one (women) or two (men) snacks per day.
16202905|NCT01371370|Other|Resistance exercise training & diet|Combination of low intensity resistance exercise training and hypocaloric diet
16202906|NCT01371357|Drug|TEST 1|2.4 g/day of guanidinoacetic acid
16202907|NCT01371357|Drug|TEST 2|2.4 g/day of guanidinoacetic acid + 3.0 g/day of choline dihydrogencitrate + 5 µg/day of B12 + 10 mg/day of B6 + 600 µg/day of folic acid
16202908|NCT01371357|Drug|TEST 3|2.4 g/day of guanidinoacetic acid + 1.6 g/day of betaine HCl + 5 µg/day of B12 + 10 mg/day of B6 + 600 µg/day of folic acid
16202909|NCT01371357|Drug|TEST 4|2.4 g/day of guanidinoacetic acid + 5 µg/day of B12 + 10 mg/day of B6 + 600 µg/day of folic acid
16202910|NCT01371344|Drug|Tacrolimus granules|oral
16202911|NCT01371344|Drug|Tacrolimus capsules|oral
16202912|NCT01371331|Drug|Tacrolimus granules|oral
16202913|NCT01371318|Other|Online Wound Electronic Medical Record|Online Wound Electronic Medical Record is a medical informatics tool that synthesizes data about complex wound problems from multiple sources and is innovative in its capability to performing these critical tasks: i) identification of the information needed to make treatment decisions at the point of care in real time ii) use intelligent search and report features to identify patients who require emergency interventions, and iii) provide evidence-based clinical decision support to clinicians
16202914|NCT01371305|Drug|BG00011|BG00011 will be administered at varying doses via subcutaneous (SC) injection
16202915|NCT01371305|Drug|Placebo|Sterile normal saline (0.9% Sodium Chloride for Injection) via Subcutaneous (SC) injections.
16202916|NCT01371292|Behavioral|Transformational Teaching|Physical education teachers randomly assigned to the experimental condition will (through a 1-day workshop format) be provided with the resources to implement transformational approaches in their day-to-day work. In addition, these teachers will be involved in a follow-up support program following the workshop to help them to implement transformational teaching strategies that were developed in the workshop.
16202917|NCT01371292|Behavioral|Standard Educational Practices|Physical education teachers randomly assigned to the control condition will take part in a professional development day workshop provided by their respective School Board. This will involve the same amount of contact time, and will take place on the same day as the transformational teaching workshop. It should be noted that the focus of those alternative workshops is unrelated to transformational leadership training.
16202918|NCT01371279|Device|Intra-Cardiac Echocardiography guided atrial fibrillation ablation|8-F or 10-F phase array ICE-probe
16202919|NCT01371266|Dietary Supplement|Honey|60.7 grams orally daily times 14 days
16202920|NCT01371266|Dietary Supplement|High Fructose Corn Syrup 55 (HFCS 55)|65.7 gram daily orally times 14 days
16202921|NCT01371266|Dietary Supplement|CHO (sugar)|50 grams daily orally times 14 days
16202922|NCT01371253|Other|Nintendo wii balance training|
16202923|NCT01371253|Other|EVA-soles|
16202924|NCT01371240|Drug|Secretin Synthetic Human (RG1068)|A maximum dose of 100 consumer unit (CU) of RG1068, synthetic human secretin (Repligen Corporation) or one CU per kg body wt for patients that weight less than 100 kg will be injected (0.2µg of RG1068 are equal to 1CU) (RepliGen Co., Waltham, MA, USA). This dose will be given as an intravenous bolus at 3 minutes before injecting the contrast.
16202925|NCT01371227|Drug|JNS002|30 mg/m2 by intravenous infusion at a rate of = 1 mg/minute on Day 4 of each 21-day cycle.
16202926|NCT01371214|Behavioral|PLIÉ (Preventing Loss of Independence through Exercise)|Integrative exercise program that incorporates elements of Eastern and Western exercise traditions to target the muscles and movements needed to help individuals with mild to moderate dementia maintain functional status and independence.
16202927|NCT01371201|Drug|Sunitinib|sunitinib 37.5 mg per day
16202928|NCT01371201|Drug|Placebo|Placebo 37.5 mg per day
16202929|NCT01371175|Biological|DNA.HIVA|0.5mg DNA.HIVA or placebo
16202930|NCT01371175|Biological|MVA.HIVA|5x10^6 pfu MVA or placebo
16202931|NCT01371175|Biological|MVA.HIVA|5x10^7 pfu MVA or placebo
16202932|NCT01371175|Biological|MVA.HIVA|2.5x10^8 pfu MVA or placebo
16202935|NCT01371149|Other|Surface parasternal electromyography (EMG) set up|Ventilation parameters will be manipulated and titrated according to physiological measurements including signal from parasternal EMG and patient- ventilator asynchrony.
16202936|NCT01371136|Procedure|curricular training|"Residents in the curricular training group will participate in the entire ex-vivo training curriculum. They will train to proficiency on a virtual reality simulator. This training program has 8 tasks at an easy, medium and hard level. They will also participate in a cognitive training component. This consists of self-directed reading, and a video training component. In the video training component, residents will watch videos of laparoscopic right and sigmoid colectomies with a staff facilitator. Finally, all residents in the intervention group will participate in a cadaver lab where they will perform a laparoscopic right or sigmoid colectomy on a cadaver."
16202937|NCT01371110|Drug|Ketamine|Ketamine hydrochloride is a nonbarbiturate anesthetic. It is formulated as a slight acid (pH 3.5 to 5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 50 or 100mg ketamine base per milliliter.
16202938|NCT01371110|Drug|Midazolam|Midazolam is a short-acting benzodiazepine central nervous (CNS) depressant.
16202939|NCT01371097|Other|Progressive Resistance strength training|Resistance strength training is given as circle training. The resistance is increased with regularly intervals.
16202940|NCT01371084|Behavioral|Pedal@Work Worksite Wellness|Participants randomized to the intervention group will be provided access to a portable pedal exercise machine, a pedometer and a worksite wellness motivational website for 12 weeks. As part of this website, participants will be emailed behavioral intervention materials a maximum of three times per week targeted at reducing sedentary time.
16202941|NCT01371084|Behavioral|Pedal@Work|Worksite wellness program.
16202942|NCT01371058|Drug|high maintenance clopidogrel|clopidogrel 150 mg/d for 30 days followed by 75 mg/d for at least 1 year； aspirin 300mg/d for 1 month followed by 100mg/d chronically；
16202943|NCT01371058|Drug|routine dual antiplatelet|clopidogel 75mg/d for at least 1 year； aspirin 300mg/d for 1 month followed by 100mg/d chronically；
16202944|NCT01371058|Drug|policosanol plus dual antiplatelet|aspirin 300 mg/d for 1 month followed by 100 mg/d chronically； clopidogrel 75 mg/d for at least 1 year policosanol 40mg/d for 6 months
16202945|NCT01371045|Other|Oral Glucose Tolerance Test (OGTT)|An OGTT is a test that lowers growth hormone in the body to very low levels for a short time in order to see how low the growth hormone levels are in your blood.
16202946|NCT01371032|Device|VideoMiller|Video-Miller laryngoscope, using the screen (Video laryngoscopy group)
16202947|NCT01371032|Device|Direct Laryngoscopy|Video-Miller laryngoscope, without screen (Direct laryngoscopy group)
16202948|NCT01371006|Drug|low dose|efavirenz single dosing once daily
16202949|NCT01371006|Drug|normal dose|efavirenz once daily
16202950|NCT01371006|Drug|low dose|Efavirenz single dosing once daily
16202951|NCT01370967|Other|Study formula feeding|Infants who are exclusively fed the new study formula at time of enrollment
16202952|NCT01370967|Other|Human milk feeding|Infants who are exclusively fed human milk at time of enrollment
16202953|NCT01370967|Other|Mixed feeding|Infants who are exclusively fed human milk and the new study formula at time of enrollment
16202954|NCT01370954|Other|CerefolinNAC®|CerefolinNAC® is an orally-administered medical food, and each caplet contains 2 mg Methylcobalamin, 600 mg N-acetylcysteine, and 6 mg of L-methylfolate Calcium (as Metafolin®), which is the primary biologically active and immediately bioavailable form of folate. Dosage will be 1 caplet QD.
16202955|NCT01370941|Dietary Supplement|Drug A Chymosin|Five drops of chymosin is added to ½ a liter of milk. This is to be consumed during breakfast.
16202956|NCT01370941|Dietary Supplement|Drug B: Placebo|B: Five drops of placebo (water) is added to ½ a liter of milk. This is to be consumed during breakfast.
16202957|NCT01370928|Device|Olympus PCF-Y0014-L|Screening colonoscopy with a prototype colonoscope
16202958|NCT01370928|Device|Standard colonoscope|Screening colonoscopy
16202959|NCT01370915|Drug|Pregabalin (Lyrica)|Patients receive oral Pregabalin 150 mg 1 hour before septal surgery, and 12 hours later
16202960|NCT01370915|Drug|Vitamin complex (placebo)|Patients receive oral Placebo(Vitamin complex) 150 mg 1 hour before septal surgery, and 12 hours later
16202961|NCT01370902|Drug|NNC 0141-0000-0100|Single dose administered subcutaneously (under the skin), up to six dose levels. Progression to next dose will be based on safety evaluation. Initiation of the MD s.c. phase will depend on the results from the SD i.v. cohorts as well as the first two dose cohorts of the SD s.c. part
16202962|NCT01370902|Drug|placebo|Single dose administered subcutaneously (under the skin) as a comparator at all dose levels
16202963|NCT01370902|Drug|NNC 0141-0000-0100|Multiple doses administered subcutaneously (under the skin) at 4 different occasions with a dosing interval of two weeks, at five different dose levels.
16202964|NCT01370902|Drug|placebo|Multiple doses administered subcutaneously (under the skin) as a comparator at all dose levels
16202965|NCT01370902|Drug|NNC 0141-0000-0100|Single dose administered intravenously (into a vein), up to nine dose levels. Progression to next dose will be based on safety evaluation. Initiation of the SD s.c. phase will depend on the results from the first three dose cohorts of the SD i.v. part
16202966|NCT01370902|Drug|placebo|Single dose administered intravenously (into a vein), as a comparator at all dose levels
16202967|NCT01370889|Drug|resveratrol|Given PO
16202968|NCT01370889|Other|laboratory biomarker analysis|Correlative studies
16202969|NCT01370876|Drug|Oxaliplatin|Oxaliplatin will be administered as a 2-hour infusion first on Day 1, followed by 5-FU i.v. infusion for 48 hours (Day 1 and Day 2), repeated every 2 weeks, 4 weeks as a cycle.
16202970|NCT01370863|Drug|SPD557|0.5 mg tablet t.i.d. for 4 weeks on top of stable PPI treatment
16202971|NCT01370863|Drug|placebo|matching placebo tablet t.i.d. for 4 weeks on top of stable PPI treatment
16202972|NCT01370837|Other|Intracutaneous injection of Candida albicans antigen.|Intracutaneous injection of 0.05 ml of four different concentrations of Candida albicans antigen on both the arm and foot.
16202973|NCT01370837|Other|Temperature measurement.|Temperature measurement at the site of injection of the highest concentration of Candida albicans antigen on the foot and the same location on the contralateral foot using an infrared thermometer.
16203020|NCT01370603|Drug|Ezetimibe/atorvastatin|Ezetimibe/atorvastatin 10 mg/40 mg combination tablet administered orally once daily
16202974|NCT01370824|Procedure|Punch biopsy|Punch biopsy is a 10 minutes treatment at the outpatient department of dermatology. Patient will lie down on a bed, the skin will be disinfected and local anaesthesia (lidocaine 1% with epinephrine) will be given, which is briefly painful. Then a PB of 3 mm is taken from the most suspected area. In the case of continuing bleeding the wound will be sutured. A properly taken biopsy will leave no or minimal scarring, but this is not relevant since a SE will be performed afterwards. In very rare cases post-biopsy bleeding or infection occurs.
16202975|NCT01370824|Procedure|Surgical excision|"Surgical excision takes place in 30 minutes. Patient will lie down on a bed, the skin will be disinfected and local anaesthesia will be given. sBCC and nBCC will be excised with a 3 mm margin, aBCC with a 5 mm margin. Most BCC can be surgically excised, but some have to be treated with Mohs micrographic surgery (MMS). MMS ensures total BCC removal, preserving as much surrounding skin with 100% margin control. All BCCs will be excised with a 2 mm margin and examined under the microscope. This will totally take 1.5-2.0 hours. If tumour is still present, another tissue layer with 2 mm margin will be excised. It usually takes removal of 1-3 tissue layers to complete MMS.
~After both treatments, wounds will be sutured and removed after 1-2 weeks, depending on the localisation. Within the first two weeks posttreatment, patients have to avoid physical heavy movements and keep the suture dry. Possible complications: scarring, continuous or subsequent bleeding, infection and dehiscent wounds."
16202976|NCT01370811|Drug|OC oral solution treatment A|
16202977|NCT01370811|Drug|OC oral solution treatment B|
16202978|NCT01370811|Drug|OC oral solution treatment C|
16202979|NCT01370811|Drug|OC oral solution treatment D|Placebo
16202980|NCT01370798|Drug|promestriene|Promestriene cream 1%, 1g per day during 2 months, cutaneous application
16202981|NCT01370798|Drug|Placebo|Placebo of promestriene cream, 1g per day during 2 months, cutaneous application
16202982|NCT01370798|Procedure|Urethroplasty|Onlay-tube-onlay urethroplasty performed by a physician expert of this technique (at least 5 years of practical ability)
16202983|NCT01370798|Radiation|Wrist X ray|Wrist X ray to follow the degree of bone maturation
16202984|NCT01370798|Procedure|Blood test|Hormonal dosage: Oestradiol, testosterone, FSH-LH and AMH
16202985|NCT01370772|Drug|Rituximab|"Cycle 1 Rituximab : 375 mg/m² i.v on day 1
~Cycle 2-6 Rituximab:500 mg/m² i.v on day 1, repeated every 28 days"
16202986|NCT01370772|Drug|Rituximab|"Prephase: Rituximab:500 mg on day 0, 2000 mg on days 1, 8, and D15
~Cycle 1-6 cycle 1 beginning at D22: Rituximab: 500 mg/m2 i.v on day 1, repeated every 28 days"
16202987|NCT01370772|Drug|Cyclophosphamide|•FCR Cycle 1-6: Cyclophosphamide : 250 mg/m² per os, days 2-4, repeated every 28 days
16202988|NCT01370772|Drug|Fludarabine|FCR Cycle 1-6: Fludarabine :40 mg/m² per os, days 2-4, repeated every 28 days
16202989|NCT01370759|Other|Cleaning capsule|Capsules containing the tested materials aimed to improve colon cleansing
16202990|NCT01370733|Device|NEST-1 (NeoSync EEG Synchronized TMS)|The NeoSync EEG Synchronized TMS (NEST) is an electromechanical medical device that produces and delivers a sinusoidal magnetic field to areas of the brain in the treatment of Major Depressive Disorder.
16202991|NCT01370733|Device|SHAM|The sham device is configured to simulate the actual NEST-1 device without sTMS therapy being actively delivered.
16202992|NCT01370720|Dietary Supplement|Recoclix|tablets; 200 mg PEA+20 mg polydatin; 2 tablets/day; 12 weeks
16202993|NCT01370720|Other|Placebo|tablets, 2tablets/day, 12 weeks
16202994|NCT01370707|Drug|Metformin|1000~1500mg/day, 24weeks
16202995|NCT01370707|Drug|CJ-30001/CJ-30002|0.6/1500mg~0.9/1500mg/day, 24weeks
16202996|NCT01370694|Drug|MK-8808|
16202997|NCT01370694|Drug|cyclophosphamide|
16202998|NCT01370694|Drug|vincristine|
16202999|NCT01370694|Drug|prednisolone|
16203000|NCT01370681|Drug|Period I : HKB0701 and SLM0807, Period II : CJ30001|
16203001|NCT01370681|Drug|Period I : CJ30001, Period II : HKB0701 and SLM0807|
16203002|NCT01370668|Behavioral|Functional remediation|"The functional remediation program is composed of 21 weekly sessions of 90 minutes, each aimed at improving the following cognitive domains: attention, memory and executive functions and psychosocial functioning.
~The program will be performed in an 12- to 15-patient group conducted by 2 experienced neuropsychologists with previous experience with bipolar patients and specific training on patients' group management."
16203003|NCT01370668|Behavioral|Psychoeducation|Group psychoeducation is a tested and manualized intervention consisting of 21 weekly sessions of 90 minutes aimed at improving 4 main issues: illness awareness, treatment adherence, early detection of prodromal symptoms and recurrences, and lifestyle regularity.
16203004|NCT01370668|Behavioral|Treatment as usual|The patients will not receive any add-on psychosocial intervention. All patients will keep on receiving standard psychiatric treatment.
16203005|NCT01370655|Drug|MK-7145|
16203006|NCT01370655|Drug|Hydrochlorothiazide (HCTZ)|
16203007|NCT01370655|Drug|Placebo to MK-7145|
16203008|NCT01370655|Drug|Placebo to HCTZ|
16203009|NCT01370642|Drug|vaniprevir|Capsules containing 150 mg vaniprevir, orally, two in the morning and two in the evening for 12 or 24 weeks
16203010|NCT01370642|Drug|Placebo to vaniprevir|Placebo to vaniprevir, capsules, orally, twice daily for 12 weeks or 24 weeks
16203011|NCT01370642|Biological|Peg-IFN|Peg-IFN 1.5 μg/kg once per week, subcutaneously (SC) for 24 or 48 weeks
16203012|NCT01370642|Drug|ribavirin|Capsules containing 200 mg RBV orally, 3 to 5 capsules, dosage based on the participant's weight (600 mg/day to 1000 mg/day), for 24 or 48 weeks
16203013|NCT01370629|Drug|Vernakalant|Prescribed at the discretion of the physician in accordance with their usual practice
16203014|NCT01370616|Drug|Ertapenem sodium|Ertapenem sodium, 1.0 g IV daily over 30 minutes at Hour 0 for 5 to 28 days
16203015|NCT01370616|Drug|Piperacillin/tazobactam sodium|Piperacillin/tazobactam sodium, 4.5 g, IV every 8 hours, given over 30 minutes at Hours 0, 8, and 16 for 5 to 28 days
16203016|NCT01370616|Drug|Piperacillin/tazobactam-matching placebo|Placebo, IV over 30 minutes, 2 times per day at Hours 8 and 16 for 5 to 28 days
16203017|NCT01370616|Drug|Amoxicillin/clavulunate potassium|If clinically indicated, participants may be switched to Amoxicillin/clavulunate potassium 625 mg administered orally, twice daily, from Day 6 to Day 28
16203018|NCT01370603|Drug|Atorvastatin|40 mg tablet administered orally once daily
16203019|NCT01370603|Drug|Ezetimibe|10 mg tablet administered orally once daily
16203021|NCT01370603|Drug|Placebo to atorvastatin|Administered orally once daily
16203022|NCT01370603|Drug|Placebo to ezetimibe|Administered orally once daily
16203023|NCT01370603|Drug|Placebo to ezetimibe/atorvastatin|Administered orally once daily
16203024|NCT01370590|Drug|Atorvastatin|20 mg tablet administered orally once daily
16203025|NCT01370590|Drug|Ezetimibe|10 mg tablet administered orally once daily
16203026|NCT01370590|Drug|Ezetimibe/atorvastatin|Ezetimibe/atorvastatin 10 mg/20 mg combination tablet administered orally once daily
16203027|NCT01370590|Drug|Placebo to atorvastatin|Administered orally once daily
16203028|NCT01370590|Drug|Placebo to ezetimibe|Administered orally once daily
16203029|NCT01370590|Drug|Placebo to ezetimibe/atorvastatin|Administered orally once daily
16203030|NCT01370564|Drug|Diuretics|Daily adjustments of diuretics and associated supplements based on cardiac filling pressures.
16203031|NCT01370551|Drug|Gynoflor|Vaginal tablet with lyophilised lactobacilli and 0.03 mg estriol; Once daily for 28 days then 3 times per week for 8 weeks;
16203032|NCT01370538|Drug|Esomeprazole|Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose
16203033|NCT01370525|Drug|Esomeprazole|Nexium 20 mg administered as 22.3 mg of esomeprasole magnesium hydrate, capsule, oral dose
16203034|NCT01370512|Drug|Droxidopa|100 mg t.i.d. for 2 days; then 200 mg t.i.d. for another 2 days
16203035|NCT01370512|Drug|Pyridostigmine Bromide|180 mg daily for 4 days
16203036|NCT01370499|Drug|LY2216684|
16203037|NCT01370499|Drug|SSRI|Participants were to enter the study taking their current stable SSRI treatment dose and maintain the same dose throughout the study.
16203038|NCT01370486|Drug|melatonin|melatonin cp 2 mg 1x/d for 1 month
16203039|NCT01370486|Drug|placebo|placebo cp 1x/d for 1 month
16203040|NCT01370460|Drug|Tranexamic Acid|Topical tranexamic acid (2g/100mL 0.9% saline)
16203041|NCT01370460|Drug|Placebo|100mL 0.9% sterile saline
16203043|NCT01370434|Drug|PAD combination|"Bortezomib 1.3 mg/m2/d iv on D 1, 4, 8, 11
~Doxorubicin 9 mg/m2/d iv on D 1-4
~Dexamethasone 40mg/d po or iv on D1-4, 8-11"
16203044|NCT01370408|Drug|Palonosetron|Prior to IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV Day 1-2 after IV chemotherapy - Dexamethasone 8 mg PO
16203045|NCT01370408|Drug|ondansetron|Prior to IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV
16203046|NCT01370408|Drug|Dexamethasone|Prior to IV chemotherapy - ondansetron 8mg IV & Dexamethasone 10 mg IV On the last day of chemotherapy - Palonosetron .25 mg IV, dexamethasone 10mg IV
16203047|NCT01370369|Drug|Testosterone gel (FE 99903)|
16203048|NCT01370356|Drug|Varenicline Tartrate|Varenicline Tartrate oral tablets 2 (0.5mg) tablets twice a day for 24 weeks (first week titration)
16203049|NCT01370356|Drug|Placebo|Matching placebo 2 oral tablets twice a day for 24 weeks (first week titration)
16203050|NCT01370343|Drug|PF-04991532 alone|a single dose of 150 mg PF-04991532, fasted
16203051|NCT01370343|Drug|PF-04991532 + cyclosporine|a single dose of 150 mg PF-04991532 + a single dose of 600 mg cyclosporine, fasted
16203052|NCT01370330|Drug|Metaiodobenzylguanidine (MIBG)|131I-MIBG Therapeutic Administration. Therapeutic 131I-MIBG will be synthesized at Jubilant DraxImage (Quebec, Canada) with specific activities of 9-18 Ci/mmole, or at Progenics with specific activity of 2,500 mCi/mg. The therapeutic dose (8-18 mCi/kg at investigator's discretion; any dose greater than 12 requires stored stem cells) will be diluted in 25-50 ml of normal saline for either preparation, and will be infused intravenously through a patient's central line, if already present, or a peripheral IV if a central line is not present.If Azedra is used, the dose will be infused over 30-60 minutes; the low specific activity preparation from Draximage will be infused over 90-120 minutes. For patients with pheochromocytoma or paraganglioma, the recommended maximum dose is 500 mCI or 12 mCi/kg.
16203053|NCT01370317|Drug|MK-1029|Five (5) X 100 mg capsules, orally, once daily for 28 days
16203054|NCT01370317|Drug|Placebo for MK-1029|Five (5) X 100 mg capsules, orally, once daily for 28 days
16203055|NCT01370304|Other|active rTMS and active Venlafaxine|"rTMS parameters : Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s.5 sessions per week for 4-6 weeks
~Venlafaxine: LP:75mg:1capsule per day for 3 days, then 2 per day for 2 to 4 weeks, if necessary 3 per day the next 2 weeks"
16203056|NCT01370304|Other|active rTMS and sham Venlafaxine|rTMS parameters : Intensity of 120% of individually determined motor threshold; frequency : 1 Hz; 360 impulsions; on period : 1 min; off period : 30 s. 5 sessions per week for 4-6 weeks
16203057|NCT01370304|Other|sham rTMS and active Venlafaxine|"rTMS parameters :same coil, same number of pulses but using an angled coil(90 degree)over the frontotemporal region
~Venlafaxine: LP:75mg:1capsule per day for 3 days, then 2 per day for 2 to 4 weeks, if necessary 3 per day the next 2 weeks"
16203058|NCT01370291|Other|active Risperidone and active rTMS|active Risperidone:------- active rTMS:auditory hallucinations:low-frequency(1Hz)applied over the left temporoparietal cortex(LTPC) negative symptoms:high-frequency（10Hz）applied over the left temporoparietal cortex(LTPC)
16203059|NCT01370291|Other|active rTMS and sham Risperidone|active Risperidone:------- ; active rTMS:auditory hallucinations:low-frequency(1Hz)applied over the left temporoparietal cortex(LTPC); negative symptoms:high-frequency（10Hz）applied over the left temporoparietal; cortex(LTPC)
16203060|NCT01370291|Other|sham rTMS and active Risperidone|active Risperidone:------- ; active rTMS:auditory hallucinations:low-frequency(1Hz)applied over the left temporoparietal cortex(LTPC); negative symptoms:high-frequency（10Hz）applied over the left temporoparietal; cortex(LTPC)
16203061|NCT01370278|Other|Normal Saline|Normal saline administered in stent/airway tubes under direct visualization via the bronchoscope.
16203062|NCT01370278|Other|Sodium Bicarbonate|4.2% bicarbonate solution mixed with equal volume of sterile water administered into stent/airway tubes under direct visualization via the bronchoscope.
16203063|NCT01370265|Drug|Regadenoson|Regadenoson (0.4 mg/5 ml IV) was administered intravenously over 10 seconds, followed immediately by saline flush.
16203213|NCT01369186|Drug|Morphine|i.v. bolus injection
16203064|NCT01370265|Drug|Adenosine|Adenosine (140 μg/kg/min) was administered intravenously over 6 minutes.
16203065|NCT01370265|Drug|N-13 ammonia|Ammonia N-13 Injection is a radioactive diagnostic agent for Positron Emission Tomography (PET) indicated for diagnostic PET imaging of the myocardium under rest or pharmacologic stress conditions to evaluate myocardial perfusion in patients with suspected or existing coronary artery disease. The N-13 ammonia used in the study was synthesized by the Mayo Cyclotron Facility as per routine institutional clinical protocol.
16203066|NCT01370239|Biological|Hu3S193|Patients will receive weekly intravenous doses of 20 mg/m2 of the antibody Hu3S193. The infusion will take 60 ± 10 minutes. The antibody should be diluted in 500 mL of normal saline.
16203067|NCT01370226|Behavioral|CBI|"The multimedia, interactive Computer Brief Intervention (CBI) condition will be delivered using tablet computers. The content and format will be easily negotiated by participants. The 30-minute interventions are designed to address the primary target behavior of alcohol use, and will include a tailored review of participants' goals/values, feedback regarding their present alcohol use patterns and consequences (either actual experiences or potential based on risk behaviors), developing a discrepancy between their alcohol use and ability to meet goals and values through a decisional balance exercise, and formulation of a change plan tailored for each participant."
16203068|NCT01370226|Behavioral|TBI|"Participants receive a 30-minute intervention session with a Master's-level clinician. The interventions are designed to address the primary target behavior of alcohol use, and will include a tailored review of participants' goals/values, feedback regarding their present alcohol use patterns and consequences (either actual experiences or potential based on risk behaviors), developing a discrepancy between their alcohol use and ability to meet goals and values through a decisional balance exercise, and formulation of a change plan tailored for each participant."
16203069|NCT01370213|Drug|Preparative Regimen|"Preparative Regimen:
~1) fludarabine 40 mg/m^2 x 4 doses on Days -22 through -19 pretransplant, 2) cyclophosphamide 50 mg/kg x 2 doses on Days -20 and -19 pretransplant, 3) total body irradiation 200 cGy twice a day (BID) (at least 6 hours apart) on Day -18 pretransplant,"
16203070|NCT01370213|Biological|NK Cells|CD3^- CD19^- selected, interleukin-2 (IL-2) activated, haploidentical donor natural killer (NK) cells infused on Day -17 pretransplant.
16203071|NCT01370213|Drug|Interleukin-2|Interleukin-2 6 million units (MU) subcutaneously (SQ) every other day for 6 doses beginning evening of NK cell infusion
16203072|NCT01370213|Biological|CD34 Graft/Anti-thymocyte globulin|Single donor filgrastim mobilized CD34+ selected peripheral blood stem cell graft (minimum cell dose of 5 x 10^6/kg) on day 0. Rabbit anti-thymocyte globulin (ATG) will be administered on day -1 (0.5 mg/kg) and day +1 and +2 (2.5 mg/kg) pretransplant per institutional guidelines. ATG dosing not identical for all patients.
16203073|NCT01370213|Biological|Donor TCR α/β-depleted Graft/ATG|Single donor TCR α/β-depleted filgrastim-mobilized peripheral blood stem cells (PBSC) graft (minimum cell dose of 5 x 10^6/kg) on day 0. ATG will be administered on days -6 and -5 (3mg/kg) for most patients.
16203074|NCT01370200|Procedure|plasma exchange treatment|the therapeutic plasma exchange is the procedure of removing the plasma of the patient including pathological macromolecules and replacing it with the replacement fluid
16203075|NCT01370187|Drug|Montelukast|Montelukast 4mg daily for 2 months
16203076|NCT01370174|Other|Physical Training Interventions|Subjects will be assigned to one of four training groups. Training will occur three times weekly for twelve consecutive weeks. The IST group will receive waist-pulls by a motorized machine to produce stepping. Subjects in the HST group will perform muscle resistance exercises. Subjects in the combined IST and HST will receive both IST and HST interventions. Participants in the SFR group will perform flexibility and relaxation exercises.
16203077|NCT01370161|Procedure|TIPS treatment|"A 8 mm Fluency stent will be used. The aim will be to reduce the portal pressure gradient (PPG) below to 12 mm Hg or 25-75% of baseline.
~Embolisation, either with coils or bucrylate, can be performed, if it is felt necessary, especially in patients where portography shows the filling of large portosystemic collaterals feeding the varices.
~After TIPS, anticoagulation will not be used as a rule, but is allowed if the attending physician thinks that it is warranted."
16203078|NCT01370161|Drug|Medical treatment|"Patients will receive vasoactive drugs up to 5 days; then a non-selective beta-blocker (propranolol) will be started with an initial dose of 40 mg, the dose of propranolol will be increased/decreased step by step to achieve a baseline heart rate of 55 bpm, or 25% reduction of basal heart rate or up to the maximum tolerated dose of propranolol.
~The second elective session of endoscopic band ligation will be performed within the first 7-14 days after the initial endoscopic treatment. The following sessions will be performed at 14 +/- 3 days intervals until variceal eradication. Once eradication is achieved, endoscopic monitoring will be performed every 6 months. If varices reappear, new band ligation will be performed."
16203079|NCT01370148|Drug|conivaptan hydrochloride|Intravenous
16203080|NCT01370135|Drug|0.5mg intraocular Ranibizumab (Lucentis)|short- and long-term effects of 0.5mg intraocular Ranibizumab (Lucentis) injections as adjuvant for patients with rubeosis and neovascular glaucoma
16203081|NCT01370122|Other|Survey|
16203082|NCT01370096|Drug|Vasopressin infusion|An intravenous infusion of vasopressin will be started at an initial rate of 0.0002U/Kg/min via the side arm of the central venous sheath. The infusion will be titrated up by 0.0001U/kg/min every minute until there has been a 20% increase in invasive mean arterial blood pressure (maximum infusion 0.002U/kg/min) and then the infusion may be titrated to maintain this blood pressure.
16203083|NCT01370096|Drug|Vasopressin infusion and epoprostenol inhalation|An intravenous infusion of vasopressin will be started at an initial rate of 0.0002U/Kg/min via the side arm of the central venous sheath. The infusion will be titrated up by 0.0001U/kg/min every minute until there has been a 20% increase in invasive mean arterial blood pressure (maximum infusion 0.002U/kg/min) and then the infusion may be titrated to maintain this blood pressure. If the target 20% increase in SBP is not achieved with vasopressin titration, the infusion will remain at 0.002U/kg/min. After a period of ten minutes of drug exposure to allow for patient equilibration, subjects will receive nebulized prostacyclin at a dose of 50ng/kg/min for 15 minutes via Aeroneb into the endotracheal tube.
16203084|NCT01370083|Behavioral|Tongue Pressure Profile Training|60 tongue-pressure tasks per session, emphasizing control of the slope of tongue pressure release, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with signals displayed on a computer.
16203214|NCT01369186|Drug|Placebo|i.v. bolus injection
16203085|NCT01370083|Behavioral|Tongue-Pressure Strength-and-Accuracy Training|60 tongue-pressure tasks per session, emphasizing maximum effort strength tasks and accuracy targets within 20-95% of each patient's maximum, informed by biofeedback. Pressures will be measured using a hand-held oral manometer (Iowa Oral Performance Instrument) with amplitude output in kiloPascals displayed on an LCD screen.
16203086|NCT01370070|Drug|MK-2206|200mg weekly repeated q 28 days
16203087|NCT01370057|Device|Thoraco-lumbo-sacral Orthosis|Treatment with Thoraco-lumbo-sacral Orthosis for Adolescent Idiopathic Scoliosis
16203088|NCT01370044|Drug|Carbogen|3 minutes administration of carbogen
16203089|NCT01370044|Drug|Placebo|3 minutes administration of oxygen
16203090|NCT01370031|Drug|Clenil® Modulite® via AeroChamber Plus™|Clenil® Modulite® 250 µg via AeroChamber Plus™ spacer during 14 days
16203091|NCT01370031|Drug|Clenil® Modulite® via Volumatic™ spacer|Clenil® Modulite® 250 µg via Volumatic™ spacer during 14 days
16203092|NCT01370031|Drug|Clenil® Modulite® via AeroChamber Plus™ plus charcoal block|Clenil® Modulite® via AeroChamber Plus™ spacer during 14 days (plus charcoal block at Day 14)
16203093|NCT01370031|Drug|Clenil® Modulite® administered via Volumatic™ spacer plus charcoal block|Clenil® Modulite® administered via Volumatic™ spacer during 14 days (plus charcoal block at day 14)
16203094|NCT01370018|Biological|alpha-1-Proteinase Inhibitor|Alpha-1-Proteinase Inhibitor was delivered I.V. A patient weighing 150 pounds was infused with approximately ½ cup containing 8.4 grams of alpha-1-Proteinase Inhibitor. Patients were admitted to hospital for infusion. The I.V. infusion was approximately 1 teaspoon/minute. Patients received weekly infusions of alpha-1-Proteinase Inhibitor for 8-12 weeks. At the time of infusion, 40ml (3 Tablespoons) of blood was collected (IRB approval #R04-003). The blood sample was used to monitor viral load, CD4 cell numbers, and alpha-1-Proteinase Inhibitor.
16203095|NCT01370005|Drug|Placebo|Placebo matching BI 10773 low dose
16203096|NCT01370005|Drug|BI 10773|BI 10773 high dose once daily
16203097|NCT01370005|Drug|Placebo|Placebo matching BI 10773 low dose
16203098|NCT01370005|Drug|BI 10773|BI 10773 low dose once daily
16203099|NCT01370005|Drug|Placebo|Placebo matching BI 10773 high dose
16203100|NCT01370005|Drug|Placebo|Placebo matching BI 10773 high dose
16203101|NCT01369979|Procedure|Liver vein catheter|Liver vein catheter is placed in the heptic vein via the femoral vein, using fluoroscpoy as guidance.
16203102|NCT01369927|Biological|Shigella Sonnei O-SPC/rBRU|
16203103|NCT01369901|Behavioral|A functional exercise program|
16203104|NCT01369901|Behavioral|A stretching exercise program|
16203105|NCT01369888|Drug|Cyclophosphamide|60 mg/m^2, intravenous (IV) (in the vein) x 2 days
16203106|NCT01369888|Drug|Fludarabine|25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)
16203107|NCT01369888|Biological|Tumor Infiltrating Lymphocytes|IV over 30 minutes on day 0
16203108|NCT01369888|Drug|IL-15|IV over 30 minutes, daily for 10 days, starting 3-4 hours after the TIL infusion. (day 0 to day 9). Doses will be increased every 3-6 patients.
16203109|NCT01369875|Drug|Cyclophosphamide|60 mg/kg/day X 2 days intravenous (IV) over 1 hour on days -7 and -6
16203110|NCT01369875|Drug|Fludarabine|25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days (days -5 to -1)
16203111|NCT01369875|Biological|Aldesleukin|720,000 IU/kg intravenous (IV) over 15 min every 8 hours (+/- 1hr) beginning within 24 hours of cell infusion and continuing for up to 5 days (max. 15 doses.)
16203112|NCT01369875|Biological|Tumor Infiltrating Lymphocytes|Intravenous (IV) over 30 minutes on day 0
16203113|NCT01369862|Biological|GHB16L2|A/Brisbane/59/07(H1N1)-like delNS1, A/Brisbane/10/07(H3N2)-like delNS1, B/Florida/04/06-like delNS1 virus reassortants
16203114|NCT01369862|Biological|Placebo|SPGNH buffer
16203115|NCT01369849|Drug|Akt Inhibitor MK2206|Given PO
16203116|NCT01369849|Drug|Bendamustine Hydrochloride|Given IV
16203117|NCT01369849|Other|Laboratory Biomarker Analysis|Correlative studies
16203118|NCT01369849|Biological|Rituximab|Given IV
16203119|NCT01369836|Drug|Tafamidis meglumin|A single oral dose of 20 mg capsule
16203120|NCT01369836|Drug|Tafamidis meglumin|A single oral dose of 40 mg capsule.
16203121|NCT01369836|Drug|Placebo|A single oral dose of matched placebo.
16203122|NCT01369797|Other|specific intervention|"Patients included in the specific intervention group will benefit from a personalized action plan presented in a multidisciplinary staff that will be established according to the detected frailties. In follow up visits, a new evaluation will be done and the action plan reviewed."
16203123|NCT01369771|Drug|Tafluprost 0.0015%|Eye Drops, Solution. Topical Use. One single-unit dose pipet of 0.3 ml solution including 0.0015 mg/ ml of Tafluprost once daily in the affected eye(s)for 12 months.
16203124|NCT01369758|Device|MyoSure Tissue Removal System|The MyoSure Tissue Removal Device consists of a hand-held tissue removal device comprising a mechanical drive assembly connected to a drive cable and associated control box on one end, and a 3 mm shaft on the other end of the device. The shaft is approximately 12 cm long and equipped with an open channel that houses an oscillating blade. When the side channel is exposed to target tissue and the motor is activated, the oscillating blade will cut the tissue within the channel. Once cut, the tissue travels down the center of the 3mm shaft via suction coupled to the proximal end of the tissue removal device, and is trapped in a vacutainer bottle.
16203125|NCT01369745|Drug|Prednisolone|Prednisolone 2.7 mg daily
16203126|NCT01369745|Drug|dipyridamole|dipyridamole 360 mg daily
16203127|NCT01369745|Drug|Prednisone|Prednisone 5 mg daily
16203128|NCT01369745|Drug|Z102|Prednisolone 2.7 mg plus dipyridamole 360 mg daily
16203129|NCT01369745|Other|placebo|
16203130|NCT01369732|Drug|recombinant human erythropoietin|We administrate the erythropoietin single bolus (500 IU/kg intravenously) 30 min before the commencement of ischemia.
16203131|NCT01369732|Drug|saline|We administrate the saline single bolus (5ml intravenously) 30 min before the commencement of ischemia.
16203132|NCT01369719|Drug|osveral|receive 20 mg/kg daily orally
16203133|NCT01369719|Drug|Desferal|40-50mg/Kg for 6 nights in each week subcutaneously
16203134|NCT01369706|Device|Hand-held metal detector|2 different hand-held metal detectors: (1) PD 140 (CEIA S.p.A., Arezzo, Italy) and (2) MH 5 (Vallon GmbH, Eningen, Germany)
16203135|NCT01369693|Procedure|Buccal administration of nicotine|Oral pouch, oral sachet, 0.3-1g, single dose. One pouch administered between upper lip and gum over 30 minutes
16203136|NCT01369680|Drug|Ketamine|Drug will be given orally three times a day at doses escalating from 0.25mg/kg/dose to 1.5mg/kg/dose in cohorts of 3. Each subject will be administered study drug for 2 weeks.
16203137|NCT01369667|Dietary Supplement|Vitamin D3|
16203138|NCT01369667|Other|Placebo|
16203139|NCT01369654|Behavioral|Computerized decision aid with 1 type of value clarification|Women will be instructed to view a computerized BSO decision support guide.
16203140|NCT01369641|Procedure|Insertion of Pressure Equalization (PE) Tubes|If the subject consents to participate in the study, a separate consent for insertion of pressure equalization (PE) tubes will be obtained. The PE tubes will then be inserted into the posterior inferior quadrant of the tympanic membrane in the office under topical anesthesia.
16203141|NCT01369641|Drug|Sodium Thiosulfate (STS)|Drops of STS will be added to the experimental ear only prior to initial cisplatin infusion.
16203142|NCT01369641|Other|Saline (Placebo)|Drops of balanced saline solution will be added to the placebo comparator ear prior to initial cisplatin infusion.
16203143|NCT01369641|Drug|Cisplatin|Cisplatin chemotherapy infusion in the dose range of 80-120mg/m2
16203144|NCT01369628|Drug|Atacicept|"Regimen 1: Atacicept 25 mg weekly for 12 weeks
~Regimen 2: Atacicept 75 mg weekly for 12 weeks
~Regimen 3: Atacicept 150 mg weekly for 12 weeks"
16203145|NCT01369615|Drug|Oxycodone hydrochloride controlled-release tablets|Oxycodone hydrochloride controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg to 240 mg daily) every 12 hours.
16203146|NCT01369602|Drug|PF-04991532|single dose 300-mg
16203147|NCT01369602|Drug|PF-04991532|single dose 300-mg
16203148|NCT01369602|Drug|PF-04991532|single dose 300-mg
16203149|NCT01369602|Drug|PF-04991532|single dose 300-mg
16203150|NCT01369589|Drug|P-552|P-552 will be administered as 10 mL mouth rinse to be swished in the mouth fro 30 seconds and then completely expectorated.
16203151|NCT01369589|Drug|Placebo|Placebo will be administered as 10 mL mouth rinse to be swished in the mouth for 30 seconds and then completely expectorated.
16203152|NCT01369576|Drug|Placebo|3.75-7.5mg 14 doses 4 weeks
16203153|NCT01369576|Drug|Zopiclone|3.75-7.5mg 14 doses 4 weeks
16203154|NCT01369550|Other|SDA soybean oil-containing foods|3 servings per day of foods containing 500 mg each SDA soybean oil plus 3 x 500 mg high-oleic sunflower oil in softgels per day.
16203155|NCT01369550|Other|High-oleic sunflower oil containing foods|3 servings per day of foods containing 500 mg high-oleic sunflower oil plus 3 x 500 mg high-oleic sunflower oil in softgels per day
16203156|NCT01369550|Other|Eicosapentaenoic acid|3 x 500 mg per day of Eicosapentaenoic acid as an ethyl ester in softgels plus 3 servings per day of high-oleic sunflower oil-containing foods
16203157|NCT01369511|Drug|LY2495655|Administered subcutaneously
16203158|NCT01369511|Drug|Placebo|Administered subcutaneously
16203159|NCT01369498|Drug|Simtuzumab|Simtuzumab administered intravenously over approximately 30 minutes every 2 weeks
16203160|NCT01369498|Drug|Ruxolitinib|In Stage 2, participants will be on a stable dose of ruxolitinib
16203161|NCT01369485|Device|(VERV™ System)|Active electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete.
16203162|NCT01369485|Device|Sham version of (VERV™ System)|Inactive (sham) electrode patches are worn for 12 weeks, one per week. The patch is placed by the subject. All subjects will have access to active patches for 9 months after the sham-controlled 12-week portion of the study is complete.
16203163|NCT01369472|Drug|Dilatrend SR capsule|single oral administration in period 1 or 2, 3 for each sequential group.
16203164|NCT01369459|Behavioral|MIP Protocol|We intend for MIP to be a 5-session, family-based protocol delivered during the early portion of ASU treatment. MIP will contain three elements deemed essential for integrating pharmacological interventions into outpatient behavioral treatment for youth: (1) standardized psychiatric assessment and family-focused psychoeducation about the target problem; (2) an approved medication regimen with demonstrated efficacy for comorbid populations; (3) family-based interventions for medication acceptance and coordination of psychiatric and behavioral services. MIP will incorporate research-proven interventions from each of these core areas.
16203165|NCT01369446|Device|Eeva System Study|The Eeva System will image embryos through cleavage and/or blastocyst stage.
16203166|NCT01369433|Drug|Tivozanib + paclitaxel|Subjects will continue to receive 0.5 mg, 1.0 mg, or 1.5 mg of tivozanib once daily for 3 weeks beginning on Day 1, followed by 1 week off treatment. On days when paclitaxel and tivozanib (AV-951) are co-administered, tivozanib will be administered immediately following the end of the paclitaxel infusion. All subjects will continue to receive IV paclitaxel 90 mg/m2, administered over 1 hour once a week for 3 weeks, followed by 1 week off.
16203167|NCT01369433|Drug|Tivozanib + temsirolimus|Subjects will receive 0.5 mg, 1.0 mg or 1.5 mg of tivozanib (AV-951) once daily for 3 weeks, followed by 1 week off. On days when tivozanib (AV-951) and temsirolimus are co-administered, tivozanib (AV-951) will be administered immediately following temsirolimus infusion. Subjects will receive 15 mg or 25 mg temsirolimus IV once weekly.
16203168|NCT01369433|Drug|Tivozanib|Subjects will receive 1.0 or 1.5 mg tivozanib (AV-951) capsules once daily for 3 weeks, followed by 1 week off.
16203169|NCT01369433|Drug|Tivozanib (AV-951)|Subjects will receive 1.0 or 1.5 mg tivozanib (AV-951) capsules once daily for 3 weeks, followed by 1 week off.
16203170|NCT01369433|Drug|Tivozanib + capecitabine|Subjects will receive 1.5 mg of tivozanib once daily for 2 weeks beginning on Day 1, followed by 1 week off. Subjects will receive Capecitabine (Xeloda®) 825 mg/m2 or 1000 mg/m² or 1250 mg/m² oral twice daily. Subjects will receive capecitabine twice daily for 2 weeks beginning on Day 1, followed by 1 week off.
16203171|NCT01369433|Drug|Tivo|Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment.
16203172|NCT01369420|Device|NanoKnife Low Energy Direct Current (LEDC) System Ablation|90 pulses of 70 microseconds each in duration will be administered per electrode pair.
16203173|NCT01369407|Other|No Intervention|Not an interventional study
16203212|NCT01369199|Drug|Entecavir and peginterferon|Entecavir 0.5 mg daily orally for 48 weeks plus peginterferon 180 µg sq weekly during weeks 9-48 of treatment.
16203174|NCT01369394|Other|Behavioral: Computer-based tailoring system|"Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will generate educational messages based on participants' responses to survey questions. The intervention group will receive tailored educational messages, whereas the control group will receive generic educational messages. The tailored and generic educational messages will be presented as to look like web pages. However, the messages will only exist on the study computer, and will not be linked to any live server or website."
16203175|NCT01369381|Procedure|Endotracheal intubation|Study patients undergo endotracheal intubation using both a conventional direct laryngoscope (Macintosh) and an alternative indirect laryngoscope (Airtraq). The order of intubation (Macintosh then Airtraq--or--Airtraq then Macintosh) is randomized.
16203176|NCT01369368|Drug|Combined use of azacitidine, valproic acid, hydroxurea and eventually donor leukocyte infusions.|Azacitidine 100 mg day 1-3 in each cycle Valproic acid, continuous therapy from day 1 All-trans retinoic acid 22.5 mg/m2 twice daily day 1-14 in each cycle Hydroxurea 500 mg initially eventually increased to 1 g daily. Eventually donor leukocyte infusions on day 10 from the second cycle.
16203177|NCT01369355|Drug|Placebo SC|Placebo will be administered subcutaneously.
16203178|NCT01369355|Drug|Placebo IV|Placebo will be administered as a single Intravenous infusion at week 0.
16203179|NCT01369355|Drug|Ustekinumab 90 mg SC q8w|Ustekinumab 90 mg will be administered subcutaneously every 8 weeks (q8w) through Week 40.
16203180|NCT01369355|Drug|Ustekinumab 130 mg IV|Ustekinumab 130 mg will be administered as a single intravenous infusion at week 0.
16203181|NCT01369355|Drug|Ustekinumab 90 mg SC q12w|Ustekinumab 90 mg will be administered as subcutaneously every 12 weeks (q12w) through Week 40.
16203182|NCT01369342|Drug|Group 1: Placebo|Form=solution for injection, route=intravenous use, in a single dose.
16203183|NCT01369342|Drug|Group 2 ustekinumab 130 mg|Type=exact, unit=mg, number=130, form=solution for injection, route= intravenous use, in a single dose.
16203184|NCT01369342|Drug|Group 3: ustekinumab approximately 6 mg/kg|Type=range, unit=mg/kg, number=6, form=solution for injection, route= intravenous use, in a single dose.weight-range based ustekinumab doses approximating ustekinumab 6 mg/kg: 260 mg (weight <= 55 kg), 390 mg (weight > 55 kg and <= 85 kg), and 520 mg (weight > 85 kg).
16203185|NCT01369329|Drug|Group 2 ustekinumab 130 mg|Type=exact, unit=mg, number=130, form=solution for injection, route= intravenous use, in a single dose.
16203186|NCT01369329|Drug|Group 3: ustekinumab approximately 6 mg/kg|Type=range, unit=mg/kg, number=6, form=solution for injection, route= intravenous use, in a single dose.weight-range based ustekinumab doses approximating ustekinumab 6 mg/kg: 260 mg (weight <= 55 kg), 390 mg (weight > 55 kg and <= 85 kg), and 520 mg (weight > 85 kg).
16203187|NCT01369329|Drug|Group 1: Placebo|Form=solution for injection, route=intravenous use, in a single dose.
16203188|NCT01369316|Procedure|Circumferential Submucosal Incision Resection|The patient is randomized, if in the active arm the procedure will continue as Circumferential Submucosal Incision Endoscopic Mucosal Resection.
16203189|NCT01369316|Procedure|Endoscopic Mucosal Resection|Patients randomised into this Intervention type will have Endoscopic Mucosal Resection performed
16203190|NCT01369303|Drug|Tenofovir 1% vaginal gel|Tenofovir 1% gel is supplied as a clear, transparent, viscous gel packaged in pre-filled single use applicators. Each applicator contains 4.0 mL of tenofovir gel (equal to 4.4 gm) at a concentration of 1% (weight for weight) formulated in purified water with edetate disodium, citric acid, glycerin, methylparaben, propylparaben and hydroxyethylcellulose, and is pH adjusted to 4-5.
16203191|NCT01369290|Drug|Venlafaxine|75 to 375 mg/day for 6 weeks. If no response at 6 weeks, reassignment to one of the other treatment groups for a further 6 to 12 weeks in phase II.
16203192|NCT01369290|Drug|bupropion|150 to 300 mg daily for 6 weeks. If no response at 6 weeks, reassignment to one of the other treatment groups for a further 6 to 12 weeks in phase II.
16203193|NCT01369290|Drug|escitalopram|10 to 30 mg daily for 6 weeks. If no response at 6 weeks, reassignment to one of the other treatment groups for a further 6 to 12 weeks in phase II.
16203194|NCT01369290|Other|Psychotherapy|Once weekly CBT psychotherapy session for 12 weeks. If no response at 12 weeks, reassignment to one of the other treatment groups for a further 6 weeks in phase II.
16203195|NCT01369290|Drug|Duloxetine|30 to 60 mg daily for 6 weeks. If no response at 6 weeks, reassignment to one of the other treatment groups for a further 6 to 12 weeks in phase II.
16203196|NCT01369277|Drug|PF-04991532|Single dose administration of PF-04991532 (100 mg, 300 mg and 750 mg) in tablet formulation under fasted condition.
16203197|NCT01369277|Drug|Placebo|Single dose administration of matching placebo in tablet formulation at the fasted state
16203198|NCT01369277|Drug|PF-04991532|Single dose administration of PF-04991532 (300 mg and 750 mg) in tablet formulation under fasted condition.
16203199|NCT01369264|Device|true left high frequency|10 Hz stimulation will be given at 110% motor threshold for 8 seconds to Brodmann areas 46, 9 and 10 in the left hemisphere. The coil will be held flat over the skull surface with the coil handle held at approximately 45 degrees to the floor
16203200|NCT01369264|Device|Passive sham left high frequency|10 Hz stimulation will be given at 110% motor threshold for 8 seconds to Brodmann areas 46, 9 and 10 in the left hemisphere. The passive (inactive) coil will be held flat over the skull surface with the coil handle held at approximately 45 degrees to the floor. An active coil will be held vertically in a mechanical holder 50 cm behind the subject head and run at 10 Hz with an intensity set to 150% of motor threshold.
16203201|NCT01369251|Behavioral|Hygiene|
16203202|NCT01369251|Procedure|Usual alcohol care|
16203203|NCT01369238|Device|Bee Venom Acupuncture Therapy|1:4000, SC 1cc/day, 2~3days/wk, for 1 month
16203204|NCT01369238|Drug|zaltoprofen|80mg/Tab, per os 1Tab tid, for 2 months
16203205|NCT01369225|Drug|AAB-003 (PF-05236812)|0.5 mg/kg AAB-003, IV
16203206|NCT01369225|Drug|AAB-003 (PF-05236812)|1 mg/kg AAB-003, IV
16203207|NCT01369225|Drug|AAB-003 (PF-05236812)|2 mg/kg AAB-003, IV
16203208|NCT01369225|Drug|AAB-003 (PF-05236812)|4 mg/kg AAB-003, IV
16203209|NCT01369225|Drug|AAB-003 (PF-05236812)|8 mg/kg AAB-003, IV
16203210|NCT01369212|Drug|Tenofovir|300 mg daily for 192 weeks (4 years)
16203211|NCT01369212|Drug|Peginterferon-alfa 2a and tenofovir|A combination of peginterferon-alfa 2a 180 µg weekly plus tenofovir 300 mg daily for 24 weeks and then only tenofovir 300 mg daily for 168 weeks (3.5 years).
16203215|NCT01369173|Other|Mexican or American foods|Participants will be randomized to an isocaloric Indigenous Mexican or a Western diet for 24 days. All foods and beverages will be prepared by the Human Nutrition Laboratory at the Fred Hutchinson Cancer Research Center. After a 4-week wash-out period, participants will cross over to the other arm and be given the alternate diet for 24 days. Blood and urine specimens will be collected before and after each feeding period to test baseline and post-intervention metabolic response as defined by various inflammatory and cancer susceptibility biomarkers including insulin-like growth factor 1 (IGF1), insulin-like growth factor binding protein 3 (IGFBP3), leptin, adiponectin, interleukin-6 (IL-6), C-reactive protein (CRP) and SAA (serum amyloid-A). DNA extracted from whole blood will be used to test whether a panel of 128 Ancestry Informative Markers (AIMs) is associated with metabolic response to the diets and other phenotypic traits of obesity, which relate to breast cancer risk.
16203216|NCT01369160|Behavioral|Quality of Life measures|measuring QOL with different therapies
16203217|NCT01369147|Drug|Parenteral nutrition energy dose at 0.6 x measured REE|Participants will be provided a total daily calorie (kcal) intake from parenteral nutrition (PN), dextrose-containing IV fluids (> 500 mL/day), propofol/clevidipine, and any enteral feedings at 0.6 x baseline metabolic energy expenditure (MEE). Total energy dosing based on real-time REE measurements will be adjusted during the ICU stay. The PN dose will be written for each 24-hr period taking into account calories provided as lipid emulsion in the sedative propofol (1.1 kcal/mL) or clevidipine (2 kcal/mL), and any dextrose-containing IV fluid orders exceeding 500 mL/day. Participants will receive a maximum of 28 days of the double blind study energy dose and will be transitioned from PN to enteral feeds as soon as tolerated and clinically indicated.
16203218|NCT01369147|Drug|Parenteral nutrition energy dose at 1.0 x measured REE|Participants will be provided a total daily calorie (kcal) intake from parenteral nutrition (PN), dextrose-containing IV fluids (> 500 mL/day), propofol/clevidipine, and any enteral feedings at 1.0 x baseline metabolic energy expenditure (MEE). Total energy dosing based on real-time REE measurements will be adjusted during the ICU stay. The PN dose will be written for each 24-hr period taking into account calories provided as lipid emulsion in the sedative propofol (1.1 kcal/mL) or clevidipine (2 kcal/mL), and any dextrose-containing IV fluid orders exceeding 500 mL/day. Participants will receive a maximum of 28 days of the double blind study energy dose and will be transitioned from PN to enteral feeds as soon as tolerated and clinically indicated.
16203219|NCT01369147|Drug|Parenteral nutrition energy dose at 1.3 X measured REE|Participants will be provided a total daily calorie (kcal) intake from parenteral nutrition (PN), dextrose-containing IV fluids (> 500 mL/day), propofol/clevidipine, and any enteral feedings at 1.3 x baseline metabolic energy expenditure (MEE). Total energy dosing based on real-time REE measurements will be adjusted during the ICU stay. The PN dose will be written for each 24-hr period taking into account calories provided as lipid emulsion in the sedative propofol (1.1 kcal/mL) or clevidipine (2 kcal/mL), and any dextrose-containing IV fluid orders exceeding 500 mL/day. Participants will receive a maximum of 28 days of the double blind study energy dose and will be transitioned from PN to enteral feeds as soon as tolerated and clinically indicated.
16203220|NCT01369134|Device|Adper Easy Bond Self-etch dental adhesive|Bonding composite to restore Class I or Class II cavities
16203221|NCT01369121|Drug|XERECEPT|BID dosing, subcutaneous for 1 year
16203222|NCT01369108|Device|Flowable composite|Restoration of small Class V and I cavities in molar and premolar teeth
16203223|NCT01369108|Device|Conventional composite restorative|Restoration of small Class V and I cavities in molar and premolar teeth
16203224|NCT01369095|Drug|Duloxetine|Capsule, Oral, 30-60mg/day, once daily, 7 weeks (Phase B), 7weeks (Phase C&D)
16203225|NCT01369095|Drug|Escitalopram|Capsule, Oral, 10-20 mg/day, once daily, 7 weeks (Phase B), 7 weeks (Phase C&D)
16203226|NCT01369095|Drug|BMS-820836 Placebo|Tablet, Oral, 0.0mg, once daily, 13 weeks (Phase B&C)
16203227|NCT01369095|Drug|BMS-820836|Tablet, Oral, 0.25mg, once daily, 6 weeks (Phase C)
16203228|NCT01369095|Drug|BMS-820836|Tablet, Oral, 0.5 mg, once daily, 6 weeks (Phase C)
16203229|NCT01369095|Drug|BMS-820836|Tablet, Oral, 1.0 mg, once daily, 6 weeks (Phase C)
16203230|NCT01369095|Drug|BMS-820836|Tablet, Oral, 2.0 mg, once daily, 6 weeks (Phase C)
16203231|NCT01369082|Drug|Maintenance Immunosuppressive Treatment|All immunosuppressive and immunomodulatory therapies are used presently to prevent rejection of transplanted islet cells. The agents listed are those used in the parent trials and continued in this trial, CIT08.
16203232|NCT01369069|Drug|IV insulin to maintain target glucose concentration of 80-130 mg/dL|Intervention is to keep glucose concentration 80-130 mg/dL for up to 72 hours after randomization. IV insulin drip will be used to maintain glucose target.
16203233|NCT01369069|Drug|Standard Care control - sliding scale insulin to keep glucose less than 180 mg/dL|Sliding scale sub q insulin given will be given up to 4 times per day based on glucose concentration. It will be given only if glucose concentration greater than or equal to 180 mg/dL.
16203234|NCT01369056|Behavioral|Advanced Adherence Counseling (AdvAdh)|AdvAdh consists of 3 individual sessions (study months 0, 3, 6) -- patient-centered, non-judgmental, Motivational Interviewing- and theory-based, semi-structured, brief, candid conversations with a trained clinical care nurse using Next Step Counseling (NSC) approach. The intervention targets: 1) accurate information about antiretroviral treatment (ART) (mechanisms of HIV and antiretrovirals) and the development of mental imagery around it; 2) promotion of perceived sense of ease and efficacy in working ART regimen into the context of one's daily life and present life circumstances that may challenge drug use persistence; 3) identification, refinement of skills promoting ease of adhering to one's ART regimen across the diverse and challenges contexts.
16203235|NCT01369043|Dietary Supplement|Vitamin E and Vitamin C|Vitamin E 400 iu/dose daily times 56 days Vitamin C 500 mg/dose twice daily times 56 days
16203236|NCT01369030|Other|Deplin®|Deplin® is an orally administered medical food available in a 7.5mg tablet or a 15mg caplet with each containing either 7.5mg or 15mg of L-methylfolate, respectively - which is the primary biologically active and immediately bioavailable form of folate. Dosage for this study will be 1 15mg caplet QD.
16203237|NCT01369017|Drug|Anakinra|Active treatment will consist of 2 doses of 1 mg/kg up to 100 mg of anakinra SQ injection.
16203238|NCT01369017|Drug|Placebo|Injection of NS
16203279|NCT01368679|Procedure|Endoprothesis Implantation|stent implantation in the abdominal artery using endovascular
16203280|NCT01368666|Device|Perceval S Valve Prosthesis|Replacement of diseased or malfunctioning native aortic valve with the Perceval S valve prosthesis
16203239|NCT01369004|Behavioral|Daily Self-weighing + weekly feedback+ weekly lessons|Daily self-weighing as a form of self-monitoring of body weight using a smart scale that sends their weights directly to a website (www.bodytrace.com) via the cellular network. They will be able to review weight trends overtime on this website via a graph showing both changes in weight and BMI. They will also receive weekly emailed feedback on their weight loss progress and compliance to the daily self-weighing prescription from a registered dietitian, as well as weekly emailed lessons with content related to behavioral weight control (e.g, how to control portion sizes, how to develop and exercise routine).
16203240|NCT01368991|Device|Kryptonite|Osteoconductive biologic bone cement to be applied upon sternal closure
16203241|NCT01368991|Procedure|Conventional closure|conventional closure, no kryptonite applied
16203242|NCT01368978|Device|InsuPatch|device which apply local heating at 38.5 degrees Celsius to the vicinity of the subcutaneous insulin infusion insertion site.
16203243|NCT01368965|Device|Ulthera® System treatment|Ulthera® System treatment delivering focused ultrasound energy
16203244|NCT01368952|Device|Pure prone positioning|Pure prone positioning device consisted of a pillow mounted on a table designed to keep the subjects sleeping prone.
16203245|NCT01368926|Drug|RO4917523|single oral doses
16203246|NCT01368926|Drug|RO4917523|multiple oral doses
16203247|NCT01368926|Drug|placebo|oral doses
16203248|NCT01368900|Device|Ulthera® System treatment|Focused ultrasound energy delivered below the surface of the skin.
16203249|NCT01368887|Drug|DPS-102|The patient will apply the treatment twice daily in the morning and at bedtime on the involved area only. The scheduled treatment duration is 12 weeks. Patient to begin treatment on the night of Visit 1.
16203250|NCT01368887|Other|Vehicle / Placebo|The patient will apply the vehicle twice daily in the morning and at bedtime on the involved area only. The scheduled treatment duration is 12 weeks. Patient to begin treatment on the night of Visit 1.
16203251|NCT01368887|Drug|Calcipotriol Monotherapy|The patient will apply the treatment twice daily in the morning and at bedtime on the involved area only. The scheduled treatment duration is 12 weeks. Patient to begin treatment on the night of Visit 1.
16203252|NCT01368887|Drug|Nicotinamide Monotherapy|The patient will apply the treatment twice daily in the morning and at bedtime on the involved area only. The scheduled treatment duration is 12 weeks. Patient to begin treatment on the night of Visit 1.
16203253|NCT01368874|Device|Ulthera® System treatment|Single treatment of focused ultrasound energy delivered below the surface of the skin.
16203254|NCT01368848|Drug|Bevacizumab|"3 cycles BCD (Bevacizumab 7,5 mg/kg i.v., Cisplatin 75 mg/m² i.v., Docetaxel 75 mg/m²) Q3W -> Staging
~-> further 3 cycles BCD Q3W -> Bevacizumab Q3W until progression"
16203255|NCT01368848|Drug|Cisplatin|"3 cycles BCD (Bevacizumab 7,5 mg/kg i.v., Cisplatin 75 mg/m² i.v., Docetaxel 75 mg/m²) Q3W -> Staging
~-> further 3 cycles BCD Q3W"
16203256|NCT01368848|Drug|Docetaxel|"3 cycles BCD (Bevacizumab 7,5 mg/kg i.v., Cisplatin 75 mg/m² i.v., Docetaxel 75 mg/m²) Q3W -> Staging
~-> further 3 cycles BCD Q3W"
16203257|NCT01368835|Device|Ulthera treatment|treatment of cheeks and upper neck area of face
16203258|NCT01368809|Drug|Saline|2 ml at induction 1-2 ml boluses as needed
16203259|NCT01368809|Drug|Fentanyl|Fentanyl (50 µg/ml) 2 ml at induction, 1-2 ml boluses as needed
16203260|NCT01368796|Biological|Agriflu|0.5mL dose IM vaccination
16203261|NCT01368796|Biological|Fluad|0.5mL dose of vaccine given IM
16203262|NCT01368796|Biological|Intanza|0.5mL dose vaccine given IM
16203263|NCT01368796|Biological|Vaxigrip|0.5mL dose vaccine given IM
16203264|NCT01368783|Drug|atazanavir|400 mg/day for 2 days
16203265|NCT01368783|Drug|Atazanavir(ATZ) and Tenofovir(TDF)|ATZ 400 mg with TDF/day for 2 days
16203266|NCT01368783|Drug|Atazanavir(ATZ) + Ritonavir|ATZ 300 mg + Ritonavir 100 mg/day for 2 days
16203267|NCT01368783|Drug|atazanavir(ATZ) + tenofovir(TDF) + ritonavir|ATZ 300 mg + Ritonavir 100 mg with TDF/day for 2 days
16203268|NCT01368770|Other|Coronary CTA|Coronary CTA using standard protocols
16203269|NCT01368770|Other|Stress MPI SPECT|Stress MPI using standard protocols
16203270|NCT01368757|Drug|Revlimid|"Dose escalation 5mg - 10mg - 15mg - 20mg in cohorts of three patients
~The first step of phase I will be 5 mg lenalidomide in a daily regimen, the next step will be 10 mg in a daily regimen, the dosis of the following steps will be increased by 5 mg each until dose limiting toxicity (DLT) is reached.
~Phase II will be started at the MTD (1 dose step below DLT) and will be administered in a daily regimen."
16203271|NCT01368744|Device|OSNA Breast Cancer System|"For in vitro diagnostic use only.
~The OSNA Breast Cancer System is an automated semi-quantitative, in vitro diagnostic test for the rapid detection of greater than (>) 0.2 mm metastases in nodal tissue removed from sentinel lymph node biopsies of breast cancer patients. Results from the assay can be used to guide the intra-operative or post-operative decision to remove additional lymph nodes and to aid in patient staging. An assay positive + or ++ result indicates the presence of metastasis (> 0.2 mm). An assay positive ++ result predicts the presence of macrometastasis (> 2 mm).
~Groups: OSNA Breast Cancer System"
16203272|NCT01368731|Procedure|Prophylactic use of coagulation therapy|The procedure is completed as per usual, and if the patient has been randomized to the intervention group the appropriate coagulation therapy will be applied immediately after standard EMR to visible vessels within the mucosal resection area.
16203273|NCT01368718|Procedure|Active CPAP is compared with sham CPAP as a control intervention.|Patients are randomized into active or control arm. After the first treatment, a washout period is installed,after which therapy is switched according to the cross-over protocol. A CPAP device consists of a unit that generates airflow, which is directed to the airway via a mask. With active CPAP, the generated airflow creates a positive pressure and prevents upper airway collapse. With sham CPAP, the generated airflow creates a very low pressure.
16203274|NCT01368705|Dietary Supplement|Standard protein delivery|Protein delivery of 1.5 g/kg/day.
16203275|NCT01368705|Dietary Supplement|Intervention 1 (2.2g/kg/day)|protein delivery of 2.2g/kg/day
16203276|NCT01368705|Dietary Supplement|Intervention 2 (3.0 g/kg/day)|protein delivery of 3.0 g/kg/day
16203277|NCT01368692|Procedure|position of shoulder retraction|position of shoulder retraction by placing a saline bag between the scapula
16203278|NCT01368692|Procedure|position of neutral shoulder|neutral shoulder position during subclavian vein catheterization
16203608|NCT01366170|Other|laboratory biomarker analysis|
16203281|NCT01368653|Behavioral|Standard treatment|Standard treatment includes a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling sessions to help smokers quit smoking
16203282|NCT01368653|Behavioral|Standard treatment+practice quitting|This intervention includes standard treatment (a 6-week supply of 21-mg nicotine patches and 4 15-minute individual smoking cessation counseling session) and an experimental treatment that involves practice quitting 7 times prior to a target quit date (for 4-12 hours per day) and returning to smoking by puffing smoke without inhaling
16203283|NCT01368653|Drug|Very low nicotine cigarettes|This intervention will be offered to a subset of smokers from both of the other study arms. To be eligible for this intervention, participants must be smoking at the follow-up interview conducted four weeks after a target quit day in the two arms listed above. Tobacco cigarettes containing very low levels of nicotine (.016-.019 mg in smoke from the cigarettes). These are to be smoked no more often than a smoker normally smokes regular cigarettes and for no longer than 6 weeks.
16203284|NCT01368627|Device|Supralimus® Sirolimus-Eluting Coronary Stent|Supralimus® Coronary Stent System consisting of the MATRIX® Coronary Stent having Sirolimus eluting from Biodegradable Polymeric Matrix on a Stainless Steel Platform, Drug concentration 1.4 µg/mm2
16203285|NCT01368614|Device|AVAPS-AE Mode of Therapy|AVAPS-AE mode is the experimental mode of therapy in this study that includes a combination of already cleared therapy attributes.
16203286|NCT01368614|Device|Respironics OnmiLab BiPAP S mode|Currently cleared Non-Invasive Ventilation (NIV) therapy modality
16203287|NCT01368614|Device|Respironics OmniLab Advanced CPAP mode|Currently cleared NIV therapy modality
16203288|NCT01368601|Procedure|CPAP (Continuous airway pressure)|To evaluate if continuous positive airway pressure (CPAP) on the lung undergoing lobectomy can decrease the inflammatory response and PPC.
16203289|NCT01368588|Radiation|radiation therapy|Undergo RT using IMRT or 3D-CRT
16203290|NCT01368588|Radiation|Whole-pelvic radiotherapy (WPRT)|Undergo whole-pelvic radiotherapy (WPRT)
16203291|NCT01368575|Procedure|CABG|CABG
16203292|NCT01368575|Procedure|CABG combined with MV repair with remodeling annuloplasty rigid ring|CABG combined with MV repair with remodeling annuloplasty rigid ring
16203293|NCT01368575|Procedure|CABG combined with MV repair with remodeling annuloplasty rigid ring|CABG combined with MV repair with remodeling annuloplasty rigid ring
16203294|NCT01368575|Procedure|CABG combined with MV repair with remodeling annuloplasty rigid ring and endoventricularplasty of subvalvular apparatus|CABG combined with MV repair with remodeling annuloplasty
16203295|NCT01368575|Procedure|CABG and MV replacement|coronary artery bypass grafting and mitral valve replacement
16203296|NCT01368562|Drug|Methylnaltrexone|Methylnaltrexone will be administered as per the dose and schedule specified in the arm.
16203297|NCT01368549|Other|Metanx® (a medical food)|Metanx® is an orally-administered medical food, and each tablet contains 3mg of L-methylfolate, 35mg of Pyridoxal-5'-phosphate, and 2 mg of Methylcobalamin- which are the biologically active and immediately bioavailable forms of folate, vitamin B6, and vitamin B12, respectively. Dosage will be 1 tablet BID.
16203298|NCT01368536|Drug|Valturna|Valturna (aliskiren 150 mg/valsartan 160 mg) tablet
16203299|NCT01368536|Drug|Amlodipine|Amlodipine 5 mg and 10 mg capsule
16203300|NCT01368536|Drug|Chlorthalidone|Chlorthalidone 15 mg and 25 mg capsule
16203301|NCT01368536|Drug|Placebo of Valturna Tablet|Matching placebo of valturna tablet
16203302|NCT01368536|Drug|Placebo Capsule|Matching placebo of Amlodipine capsule OR Matching placebo of chlorthalidone capsule
16203303|NCT01368523|Drug|nilotinib|
16203304|NCT01368510|Behavioral|Intensive Cognitive Behavioral Therapy (CBT)|Nondrug psychotherapy administered daily 5 days/week for 4 weeks
16203305|NCT01368510|Behavioral|Waitlist|Minimal contact waitlist weekly for 4 weeks
16203306|NCT01368497|Drug|Entecavir and peginterferon|Entecavir 0.015 mg/kg/day (up to 0.5 mg maximum daily dose) once daily for 48 weeks and Peginterferon alfa-2a 180 µg/1.73m2 subcutaneously once weekly for 40 weeks beginning 8 weeks after entecavir monotherapy).
16203307|NCT01368484|Dietary Supplement|Sunflower oil|1500 mg sunflower/day for 10 weeks
16203308|NCT01368484|Dietary Supplement|Docosahexanoic acid|1500mg/day for 10 weeks
16203309|NCT01368471|Device|MGuard|MGuard™ stent comprises a balloon-expandable, thin-strut stainless steel (316L) bare metal stent platform (strut width 100 µm) with mesh sleeve fibers of polyethyleneterephtalate (fiber width of 20 µm) attached to its outer surface. These fibers act like a net (aperture size 150 x 180 µm) preventing distal embolization of the plaque debris/thrombus placed between the vessel wall and the stent.
16203310|NCT01368471|Device|Control BMS or DES|Control BMS or DES
16203311|NCT01368458|Other|Conversion to Antipsychotic Monotherapy|Patients assigned to the antipsychotic monotherapy group will have the dosage of their secondary (i.e. one due to be reduced) antipsychotic reduced by decreased by approximately 1/3 every 3 weeks. Dosage of the primary antipsychotic will be left unchanged.
16203312|NCT01368445|Drug|azelastine hydrochloride 0.15% Nasal Spray|1644 mcg, 2 sprays per nostril twice daily AM & PM)
16203313|NCT01368445|Drug|azelastine hydrochloride 0.15% and Placebo|822 mcg azelastine hydrochloride 0.15%, 2 sprays per nostril once daily (AM) and 0mg placebo spray 2 sprays per nostril once daily (PM)
16203314|NCT01368445|Drug|Azelastine 0.1%, Nasal Spray|1096 mcg, Azelastine 0.1%,2 sprays per nostril twice daily (AM & PM)
16203315|NCT01368432|Drug|Escitalopram|Escitalopram 10 mg or 20 mg daily for 12 weeks by mouth
16203316|NCT01368432|Drug|Placebo|Sugar pill placebo
16203317|NCT01368419|Drug|Endostar|75mg Endostar in 235mL normal saline, 24h continuous infusion, 6 weeks
16203318|NCT01368419|Radiation|Radiotherapy|6～15MV X-ray, 2Gy/time，5times/week，6 weeks
16203319|NCT01368406|Behavioral|wellness program|12-week weight management intervention in patients with severe mental disorders. In the 1-hour weekly group sessions topics like dietary choices, lifestyle, physical activity and self-esteem were discussed with outpatients and their relatives
16203320|NCT01368393|Procedure|Electroacupuncture|Patients randomized to the experimental group will receive electroacupuncture at acupoints relevant to the treatment of abdominal pain and anxiety, including Zusanli (stomach meridian ST-36), Hegu (large intestine meridian LI-4), and Neiguan (pericardium meridian PC-6). Electric stimulation will be employed to the needles
16203609|NCT01366170|Other|mass spectrometry|
16203610|NCT01366157|Genetic|microarray analysis|
16203321|NCT01368393|Procedure|Sham acupuncture|"Sterile blunt-tip needles will be placed (without skin penetration) 15 mm away from the acupoints. Pseudostimulation will be given by deliberately connecting the needle to the incorrect output socket of the electroacupuncture device, thus there will be no flow of electric current."
16203322|NCT01368380|Behavioral|Psychological intervention|Couples in the intervention group attends six to eight couple-sessions performed by a psychologist.
16203323|NCT01368367|Other|Intensive exercise|Both groups, stretching exercise monitored once per week Intensive exercise group An aerobic and resisted exercise program for a minimum of three times per week for a total of approximately 60 minutes per session for six weeks. Aerobic exercise will be conducted on a treadmill, exercise bike or arm ergometer at an intensity of 80 % of VO2peak during initial assessment. For resistance exercise, the three repetition maximum (3RM) (maximum weight able to be lifted a maximum of 3 times) will be established and then resisted exercise will be commenced at 60% of the 3RM in the first week. Resisted exercise will then be progressed weekly by 5-10% by increasing the number of repetitions or the weights lifted. All resisted exercises will be done using variable resistance machines or free weights.
16203324|NCT01368354|Behavioral|CLTS|CLTS (Community Led Total Sanitation) involves facilitating a process to inspire and empower rural communities to stop open defecation and to build and use latrines, without offering external hardware subsidies. Communities are encouraged to appraise and analyse their own sanitation profile, including the extent of open defecation and the spread of faecal-oral contamination. This approach ignites a sense of disgust and share among the community. The community then collectively realises the impact of its unsanitary practices and this realisation mobilises and initiates collective action to improve the existing sanitation profile.
16203325|NCT01368341|Drug|Doxycycline|1 tablet, 100 mg, b.i.d. 14 days
16203326|NCT01368341|Drug|Phenoxymethylpenicillin|Tablet 650 mg, 2 tablets, t.i.d., 14 days
16203327|NCT01368341|Drug|Amoxicillin|Capsula, 500 mg, t.i.d., 14 days
16203328|NCT01368328|Dietary Supplement|Chromium nicotinate|The intervention is offered during three months. There is a placebo group, chromium nicotinate 50 mcg group and chromium nicotinate 200 mcg group. Each patient is oriented to consume one capsule one hour after lunch and one capsule one hour after dinner.
16203329|NCT01368315|Drug|CT327 application|Topical administration of 0.5 grams cream administered twice daily for ten days to one out of four test fields marked on the patient's back.
16203330|NCT01368315|Drug|Placebo|Topical administration of 0.5 grams cream administered twice daily for ten days to one out of four test fields marked on the patient's back.
16203331|NCT01368315|Drug|Active comparator|Topical administration of an active comparator administered twice daily for ten days to one out of four test fields marked on the patient's back.
16203332|NCT01368315|Drug|No intervention|No intervention to one out of four test fields marked on the patient's back.
16203333|NCT01368302|Behavioral|Attention Bias Modification Treatment (ABMT)|Attention training using a computerized spatial attention task (dot-probe) modified to alter threat-related attention patterns.
16203334|NCT01368289|Procedure|Endoscopic Mucosal Resection|Endoscopic Mucosal Resection of large sessile colonic polyps.
16203335|NCT01368276|Biological|Talimogene Laherparepvec|Up to 4 mL of 10⁸ pfu/mL/per intratumoral injection
16203336|NCT01368276|Drug|Granulocyte Macrophage Colony-Stimulating Factor (GM-CSF)|125 µg/m² subcutaneous injection
16203337|NCT01368263|Drug|goserelin acetate|Given SC
16203338|NCT01368263|Drug|letrozole|Given PO
16203339|NCT01368263|Drug|anastrozole|Given PO
16203340|NCT01368263|Drug|chemotherapy|Standard chemotherapy
16203341|NCT01368263|Procedure|Surgery|
16203342|NCT01368250|Procedure|Transcatheter Aortic Valve Implantation|Minimal Invasive Implantation of a biological prosthesis in Aortic Position
16203343|NCT01368237|Radiation|Computed tomography scan|Computed tomography will be performed using a 320 multidetector computed tomography scanner and may include coronary calcium score, coronary angiography and imaging of myocardial perfusion, function and viability.
16203344|NCT01368224|Dietary Supplement|Lactobacillus paracasei NCC 2461 and Bifidobacterium longum NCC3001|"1 treatment unit, in the form of a sachet of powder, to be reconstituted in a glass of water and taken once daily for 8 weeks (from D1 to D57), except if the last visit is bring forward or put back for no more than 3 days, in which case the subject will continue treatment until the final visit.
~Oral route."
16203345|NCT01368211|Biological|2-4-day-old Mirasol-treated Platelets Transfusion|"2-4-day-old Mirasol-treated Platelets Units with:
~Platelet yield between 2.4x10e11 and 4.5x10e11
~Plasma carryover of >32%
~Cell count > 800x103/µL"
16203346|NCT01368211|Biological|2-4-day-old Untreated Platelets Transfusion|"2-4-day-old Untreated Platelets Units with:
~Platelet yield between 2.4x10e11 and 4.5x10e11
~Plasma carryover of >32%
~Cell count > 800x103/µL"
16203347|NCT01368198|Other|Systane Balance Lubricating Eye Drops|One instillation of the eye drop in each eye
16203348|NCT01368198|Other|OPTIVE™|One instillation of the eye drop in each eye
16203349|NCT01368172|Behavioral|Physical Activity Guidelines|Participants in the Physical Activity Guidelines Arm will be asked to participate in at least 20 minutes of moderate to heavy intensity aerobic activity 2 times per week as well as strength training exercises (moderate intensity) 2 times per week. The Control Arm will not be supervised to follow the physical activity guidelines
16203350|NCT01368159|Device|Compression Stockings|"The trial objectives are to compare efficacy relative to pain, along the route of the vein following echoguided endovenous injection of sclerotherapeutic foam into the Great Saphenous vein, of class III microfibre compression (centred at 25 mm Hg) versus class I (10-15 mm Hg) versus class III cotton compression (20 to 36 mm Hg) over 21 days. The main contrast will be the comparison between the first two groups mentioned. All other contrasts will be secondary. The Class I compression versus The two class III compressions contrast will also be studied."
16203351|NCT01368146|Device|IV Clear™|Polyurethane film with a silicone adhesive dressing containing chlorhexidine and silver
16203352|NCT01368146|Device|Tegaderm CHG™|Polyurethane film with a polyacrylate adhesive and a polyol hydrogel containing 2% w/w chlorhexidine gluconate
16203353|NCT01368146|Device|Silicone Vehicle Control Dressing|Polyurethane film with silicone adhesive dressing, without antimicrobials
16203354|NCT01368120|Device|IV Clear™ Dressing|Polyurethane film, silicone adhesive dressing with chlorhexidine and silver
16203611|NCT01366157|Genetic|protein expression analysis|
16203355|NCT01368120|Device|Tegaderm CHG™|Polyurethane film, polyacrylate adhesive and a polyol hydrogel containing 2% w/w chlorhexidine gluconate
16203356|NCT01368120|Device|Silicone Vehicle Control Dressing|Polyurethane film with silicone adhesive dressing, without antimicrobials
16203357|NCT01368107|Drug|placebo|Placebo before the 1st (D0, D7, D14)and during the 3rd CT cycle (D57, D64, D71)
16203358|NCT01368107|Drug|interleukin 7|patients will receive an induction cycle of CYT107 (10µg/kg/week subcutaneously for 3 weeks) before the 1st CT cycle (D0, D7, D14) and the placebo during the 3rd CT cycle (D57, D64, D71)
16203359|NCT01368107|Drug|interleukin 7|patients will receive the placebo before the 1st CT cycle (D0, D7, D14) and a delayed treatment with CYT107 (10µg/kg/week subcutaneously for 3 weeks) during the 3rd CT cycle (D57, D64, D71)
16203360|NCT01368107|Drug|interleukin 7|patients will receive an induction cycle of CYT107 (10µg/kg/week subcutaneously for 3 weeks) before the 1st CT cycle (D0, D7, D14) and a maintenance cycle of IL-7 (10µg/kg/week subcutaneously for 3 weeks) during the 3rd CT cycle (D57, D64, D71)
16203361|NCT01368094|Procedure|Drain removal at D4|If no pancreatic fistula (PF) or deep SSI is highlighted neither on the CT-scanner nor with biological analysis, on day 3 postoperatively, the drain will be removed on the 4th postoperative day, at the patient's bedside.
16203362|NCT01368094|Procedure|Standard drain removal|If no pancreatic fistula (PF) or deep SSI is highlighted on the CT-scanner on day 3 postoperatively, the drain will be removed following the clinical routine practice of the surgical team that takes the patient in charge. The patient will leave the department when the surgeon deems necessary.
16203363|NCT01368081|Drug|Metformin|Metformin tablets 500-2250 mg a day (twice or three times per day)
16203364|NCT01368081|Drug|BI 10773|BI 10773 low dose tablet once daily
16203365|NCT01368081|Drug|Placebo (low dose)|Placebo tablets once daily
16203366|NCT01368081|Drug|BI 10773|BI 10773 high dose tablet once daily
16203367|NCT01368081|Drug|Placebo (high dose)|Placebo tablets once daily
16203368|NCT01368068|Drug|Tibolone|2.5mg/oral/daily
16203369|NCT01368068|Drug|Escitalopram|10mg/oral/daily
16203370|NCT01368068|Drug|Natvia|serving size: 0.09g per tablet
16203371|NCT01368055|Radiation|70 Gy/CGE|Low Risk
16203372|NCT01368055|Radiation|72.5 Gy/CGE|Intermediate Risk
16203373|NCT01368029|Biological|Lactobacillus rhamnosus GG ATCC 53103 (LGG)|Study drug capsules (1x10^10 LGG/capsule) are to be taken orally twice a day every day on an outpatient basis for 28 days
16203374|NCT01368029|Biological|Placebo|Placebo capsules composed of microcrystalline cellulose are to be taken orally twice a day on an outpatient basis for 28 days.
16203375|NCT01368016|Drug|Nicotine|A single 6 mg dose of an experimental Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits
16203376|NCT01368016|Drug|Nicotine|A single 4 mg dose of a marketed Nicotine Gum, with a 36-hour washout between visits
16203377|NCT01368003|Drug|STA9090|200 mg/m^2 IV every week for 3 weeks on, 1 week off (days 1,8,15 on a 28-day cycle)
16203378|NCT01368003|Drug|STA9090 with Dutasteride|Dutasteride 3.5 mg orally per day STA9090 200 mg/m^2 IV every week for 3 weeks on, 1 week off (days 1,8,15 on a 28-day cycle)
16203379|NCT01367990|Drug|Norepinephrine|"The occipital scalp zone at risk for alopecia will be identified. The norepinephrine treatment site will be randomized to receive consistent treatment of one half of the scalp risk zone. Approximately 1.6 mL of a 400 mM norepinephrine solution will be applied topically to the norepinephrine site approximately 20 minutes prior to each radiation treatment, and placebo will be applied to the contralateral side (30-35 treatments)."
16203380|NCT01367964|Drug|adrenocorticotropin hormone|ACTH 16 units intramuscular injection once daily for 2 weeks
16203381|NCT01367951|Procedure|Surgical fixation|"The fractures will be reduced and stabilized by use of plates and screws
~Attempt will be made to stabilize ribs 3-7, as these are surgically accessible and most important in maintaining integrity of the chest cavity.
~Goal is not to fix all the fractures, but to fix sufficient fractures to create an internal splint and allow chest wall motion to occur as a unit. In case of fibs fractured at numerous locations, as many fragments will be reduced and stabilized as necessary to ensure movement as a unit.
~Chest tube(s) will be placed at the discretion of the treating surgeon in patients with pre-operative or intra-operative violation of the pleural cavity (ie pre-op pneumothorax/haemothorax, iatrogenic pleural injury). No post-operative drains will be inserted."
16203382|NCT01367938|Device|OMNI Apex Ultracongruent Knee Device|
16203383|NCT01367925|Device|Stryker Triathlon® CS Tibial Insert|
16203384|NCT01367925|Device|Stryker Triathlon® PS Tibial Insert|
16203385|NCT01367912|Drug|estradiol tablet|received 2 mg estradiol tablets orally two times daily beginning from the first day after hCG injection, in addition to vaginal progesterone gel
16203386|NCT01367912|Drug|estradiol tablet|received 2 mg estradiol tablets orally two times daily beginning from the fifth day after hCG injection, in addition to vaginal progesterone gel.
16203387|NCT01367886|Drug|fesoterodine|Fesoterodine 4 mg. tablet by mouth daily for six weeks
16203388|NCT01367873|Drug|Placebo|Oral, matching number of placebo capsule(s) with active arm
16203389|NCT01367873|Drug|VIA-3196|Oral, capsule(s)
16203390|NCT01367860|Procedure|Open microdiscectomy|The open microdiscectomy, will be performed under general anesthesia in the prone position with horizontal. The level of the spine indicated for surgical treatment will be identified with the aid of fluoroscopy. An incision is made about the dorsal disc level involved with dissection of the paravertebral muscles on the side of disc herniation. After laminectomy and resection of part of the yellow ligament, partial discectomy is done under direct vision.
16203391|NCT01367860|Procedure|Percutaneous Diskectomy SpineJet|Percutaneous Diskectomy SpineJet be performed under local anesthesia, in which a needle is placed via percutaneous posterolateral extra-pedicular, below the neural foramen in the center of the disc, using the traditional approach for discography. The researcher will confirm the proper placement of the needle in front and side incidences on the fluoroscopy.
16203392|NCT01367847|Behavioral|Helping the Noncompliant Child (HNC)|Well-established behavioral parent training program (McMahon & Forehand) for parents of 3 to 8 y.o. children with externalizing problems
16203393|NCT01367847|Behavioral|Technology-Enhanced Helping the Noncompliant Child (TE-HNC)|Standard HNC program plus technology-enhancements (see description under Arm)
16203612|NCT01366157|Other|immunohistochemistry staining method|
16203613|NCT01366157|Other|laboratory biomarker analysis|
16203394|NCT01367834|Drug|somatotropin|Subjects will receive 5 mg somatotropin (growth hormone) pens with cartridges. Subcutaneous injections are to be given every evening around bedtime. Dosing regimen: 50 mcg/kg/day to be adjusted at 4 month intervals to the closest 0.1 mg. Subjects will be given 12 months of treatment (from 12 to 24 months of life). Subjects will visit their pediatrician or pediatric endocrinologist at 4 and 8 months of life.
16203395|NCT01367808|Drug|Placebo|The subjects will be given placebo twice a day for 5 days prior to the study
16203396|NCT01367808|Drug|vorikonazole|The subject will be given vorikonazole twice a day for 5 days prior to the study. The dose will be 400 mg twice a day on day one ans 200 mg twice a day on days 2-5.
16203397|NCT01367808|Drug|posakonazole|The subjects will be given posaconazole 400 mg twice a day for 5 days prior to the study.
16203398|NCT01367782|Device|repetitive transcranial stimulation (r-TMS)|Active treatment with the H-coil will include stimulation over the motor cortex (1 Hz stimulation 110% of the motor threshold for 15 minutes) and over the prefrontal cortex (10Hz stimulation 100% of the motor threshold, 2 seconds each train, 20 seconds between trains, for 15 minutes).
16203399|NCT01367782|Device|repetitive transcranial stimulation (r-TMS)|Sham treatment with the H-coil will include sham stimulation over the motor cortex and over the prefrontal cortex.
16203400|NCT01367769|Other|No intervention|There will be no intervention in this study.
16203401|NCT01367756|Drug|RO4995819|multiple oral doses, Days 10-16
16203402|NCT01367756|Drug|citalopram|multiple oral doses, Days 1-16
16203403|NCT01367756|Drug|placebo|multiple oral doses, Days 10-16
16203404|NCT01367743|Drug|epinephrine perfusion|perfusion of commercial epinephrine prepared in syringes in order to obtain a MAP of 65-70 mmHg
16203405|NCT01367743|Drug|norepinephrine perfusion|perfusion of commercial norepinephrine prepared in syringes in order to obtain a MAP of 65-70 mmHg
16203406|NCT01367717|Dietary Supplement|Creatine Monohydrate|Each subject ingested 10 grams of commercially available creatine monohydrate orally. This was equivalent to two teaspoons according to the manufacturer's recommendations. The creatine was then solubilized in 8 oz. of water and 2 tablespoons of Tang brand orange flavored drink mix.
16203407|NCT01367717|Dietary Supplement|Creatine Ethyl Ester|Each subject ingested 10 grams of creatine ethyl ester orally. This was equivalent to 14.25 pills according to the manufacturer's ingredient description. The pill capsules were ground into a powder, which was added to 8 oz of water along with 2 tablespoons of Tang brand orange drink.
16203408|NCT01367704|Behavioral|"Coaching Boys Into Men program"|Coaching Boys into Men (CBIM) program consists of a 60 minute training for high school coaches led by a violence prevention advocate to introduce coaches to the rationale for CBIM and the CBIM Coaches Kit. The Coaches use this CBIM toolkit to provide weekly discussions with their athletes (generally 10-15 minute mini-sessions) throughout their athletic season (11 weeks). Discussion topics include how to prevent disrespectful and harmful behaviors towards women and girls and how to promote healthy choices and relationships among youth.
16203409|NCT01367691|Device|CRT reprogramming (Medtronic CRT)|CRT devices will be reprogrammed according to CMR analysis
16203410|NCT01367678|Device|Laryngeal Mask Airway Supreme|Directly measured mucosal pressures
16203411|NCT01367678|Device|i-Gel extraglottic airway device|Directly measured mucosal pressures
16203412|NCT01367665|Drug|vismodegib|150 mg once daily until disease progression or unacceptable toxicity
16203413|NCT01367652|Drug|Letrozole|2.5 mg tablet
16203414|NCT01367652|Drug|Letrozole|2.5 mg Tablet
16203415|NCT01367639|Behavioral|Inquiry Based Stress Reduction (IBSR) program|"The IBSR (Inquiry-based stress reduction) intervention, developed by Byron Katie, trains participants to reduce their perceived level of stress by self-inquiry of their thoughts and beliefs connected to stressful circumstances or symptoms. This meditative process, named The Work, enables the participants to identify and question the stressful thoughts that cause their suffering. The core of IBSR is simply four questions and a turnaround, which is a way of experiencing the opposite of what the participant believes. This process is simple, powerful and provides skills for self-inquiry and management of stressful thoughts that can be easily implemented in daily life"
16203416|NCT01367626|Drug|letrozole|2.5 mg tablet
16203417|NCT01367626|Drug|letrozole|2.5 mg tablet
16203418|NCT01367613|Drug|SC Methylnaltrexone|
16203419|NCT01367600|Drug|SC Methylnaltrexone (MNTX)|
16203420|NCT01367587|Drug|IV Methylnaltrexone|
16203421|NCT01367574|Drug|SC MNTX|Dose 1
16203422|NCT01367574|Drug|SC MNTX|Dose 2
16203423|NCT01367574|Drug|SC MNTX|Dose 3
16203424|NCT01367561|Drug|Naloxone|
16203425|NCT01367561|Drug|IV Methylnaltrexone (MNTX)|
16203426|NCT01367561|Drug|Placebo|
16203427|NCT01367548|Drug|IV Methylnaltrexone (MNTX)|
16203428|NCT01367548|Drug|Placebo|
16203429|NCT01367535|Drug|SC Methylnaltrexone (MNTX)|
16203430|NCT01367535|Drug|IV Methylnaltrexone (MNTX)|
16203431|NCT01367535|Drug|Oral Paroxetine|
16203432|NCT01367535|Drug|SC Placebo|
16203433|NCT01367522|Drug|SC Methylnaltrexone (MNTX)|
16203434|NCT01367509|Drug|Methylnaltrexone (MNTX)|
16203435|NCT01367496|Drug|SC Methylnaltrexone (MNTX)|Dose 1
16203436|NCT01367496|Drug|SC Methylnaltrexone (MNTX)|Dose 2
16203437|NCT01367496|Drug|SC Methylnaltrexone (MNTX)|Dose 3
16203438|NCT01367496|Drug|IV Methylnaltrexone (MNTX)|
16203439|NCT01367483|Drug|IV methylnaltrexone (MNTX)|
16203440|NCT01367470|Dietary Supplement|VSL#3 probiotic preparation|VSL#3 is a mixture of 8 different strains of lactic acid bacteria and bifidobacteria at a concentration of 900 billion bacteria per sachet. The suggested dosage is 1 to 2 sachets per day.
16203441|NCT01367470|Other|Placebo VSL#3|Placebo VSL#3 is a base of corn starch containing no active ingredient.
16203442|NCT01367457|Other|Temsirolimus (Non-Interventional Study)|There is not any intervention in this study.
16203443|NCT01367444|Drug|SAR422459|"Pharmaceutical form: sterile solution, 100 microliters (μL) aliquots in 0.3 milliliter (mL) type I borosilicate glass 'V' vials with a butyl stopper and aluminum crimp seal.
~Route of administration: subretinal injection"
16203444|NCT01367431|Dietary Supplement|Xanthohumol|PK study with one capsule of one of the three doses randomly assigned
16203445|NCT01367418|Drug|Patient controlled analgesia (PCA)|Morphine 1 mg/ml
16203446|NCT01367418|Drug|Thoracic Epidural Analgesia (TEA)|Intra-operatively: Bupivacaine 0.5% with adrenaline Post-operatively: Ropivacaine 0.2% + sufentanil 1 ug
16203447|NCT01367405|Procedure|Surgical decompression|Surgical decompression within 24 hour postinjury
16203448|NCT01367405|Procedure|Conservative treatment|Usual conservative treatment without surgery
16203449|NCT01367392|Device|biopsy or ablation|biopsy or ablation performed as in standard of care with assistance of ActiSight Needle Guidance system
16203450|NCT01367379|Procedure|24 hour EKG and blood pressure monitor|All subjects will have non-invasive 24 hour EKG and 24 hour EKG monitoring for 24 hours.
16203451|NCT01367379|Other|Blood and urine sampling|Right before and after the duty loading, all subjects will have blood samplings, including CRP, WBC, IL-6, Fibrinogen, insulin, IL-6, Procalcitonin, TNF-alfa, catecholamine level. Right after the duty loading, all subjects will have urine samplings for cortisol and catecholamine level.(blood : 15CC/time and 2~4 times/month)
16203452|NCT01367366|Procedure|PET and EBUS-TBNA|PET and EBUS-TBNA once, respectively
16203453|NCT01367353|Procedure|surgery or debulking surgery|surgery or debulking surgery
16203454|NCT01367340|Behavioral|Loaded sit-to-stand resistance exercise|Loaded STS exercise at home, 3 times a week for 6 weeks
16203455|NCT01367340|Behavioral|Physical activity intervention|The intervention is based on the social cognitive theory and the transtheoretical model. There are two principle components, the individual consultation and the small group PA activities. In the individual consultation, assessment of current stage of readiness for PA will be performed first. Then, individualized, stage-matched feedback will be sent to the participants. Small group PA activities will be held every 2 weeks in order to increase learning opportunity by peer interaction, make exercise fun, and introduce a role model.
16203456|NCT01367327|Behavioral|Loaded sit-to-stand exercise|Loaded sit-to-stand exercise at home, 3 times a week for 6 weeks
16203457|NCT01367327|Behavioral|Synchronized music|Synchronized music for loaded sit-to-stand exercise to guide movement
16203458|NCT01367314|Drug|NVC-422|Dermal Gel applied 3 times per day for 7 days
16203459|NCT01367301|Drug|paclitaxel|Given IV
16203460|NCT01367301|Drug|carboplatin|Given IV
16203461|NCT01367301|Radiation|external beam radiation therapy|Undergo external beam radiation therapy
16203462|NCT01367301|Radiation|brachytherapy|Undergo HDR brachytherapy
16203463|NCT01367301|Radiation|intensity-modulated radiation therapy|Undergo IMRT
16203464|NCT01367301|Other|laboratory biomarker analysis|Correlative studies
16203465|NCT01367288|Drug|Zometa + Neoadjuvant therapy|4 mg (in a 15 min. infusion) every 3 weeks for a total of 8 injections
16203466|NCT01367288|Drug|Neoadjuvant therapy|4 injections of doxorubicin (60 mg/m²) combined with cyclophosphamide (600 mg/m²) every 3 weeks (+/- 2 days), followed by 4 injections of docetaxel (100 mg/m²) every 3 weeks (+/- 2 days)
16203467|NCT01367275|Drug|Brivanib|800 mg (4 x 200 mg tablets) self-administered orally at approximate same time each day on a continuous daily schedule Days 1-14 of 14 day cycle.
16203468|NCT01367275|Drug|Irinotecan|180 mg/m^2 by vein on Day 1 of a 14 day cycle.
16203469|NCT01367262|Drug|LY2886721|Administered orally
16203470|NCT01367249|Drug|Bromfenac Ophthalmic Solution|Sterile ophthalmic solution
16203471|NCT01367249|Drug|Placebo|Sterile ophthalmic solution
16203472|NCT01367236|Drug|standard care|"atazanavir 300 mg daily
~ritonavir 100 mg daily
~tenofovir 245 mg daily*
~emtricitabine 200 mg daily*"
16203473|NCT01367236|Drug|novel treatment|"darunavir 800 mg daily
~ritonavir 100 mg daily
~lamivudine 300 mg daily** and abacavir 600mgs daily**
~maraviroc 150 mg once daily"
16203474|NCT01367223|Dietary Supplement|solution of amino acids supplemented with glutamine|parenteral nutrition by range of ages (recommendation from ESPGHAN and ESPEN:1 month to 3 years, 3 to 5 years, 6 to 12 and standard adult).Study Parenteral nutrition will be assessed the first 5 days.
16203475|NCT01367223|Dietary Supplement|amino acids not supplemented with glutamine|parenteral nutrition by range of ages (recommendation from ESPGHAN and ESPEN:1 month to 3 years, 3 to 5 years, 6 to 12 and standard adult).Study Parenteral nutrition will be assessed the first 5 days.
16203476|NCT01367210|Drug|Maraviroc, Darunavir/r|Maraviroc 300 mg Darunavir 800 mg Ritonavir 100 mg
16203477|NCT01367210|Drug|current antiretroviral therapy with 3 drugs|To continue the assumption of previous HAART
16203478|NCT01367197|Behavioral|exercise training|group based exercise training
16203479|NCT01367158|Biological|Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine|The lyophilized Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine reconstituted with one dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
16203480|NCT01367158|Biological|Meningococcal (group B) multicomponent recombinant adsorbed vaccine|Liquid Meningococcal (group B) multicomponent recombinant adsorbed vaccine
16203481|NCT01367158|Biological|Tdap|Sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components intended for intramuscular injection
16203482|NCT01367145|Drug|OMACOR|4 capsules OMACOR 1g per day
16203483|NCT01367145|Drug|Placebo|4 capsules placebo per day
16203484|NCT01367132|Procedure|Doppler ultrasound|Ultrasound using Doppler mode to detect blood flow in umbilical cord vasculature and determine the number of vessels present
16203485|NCT01367119|Drug|Ketamine|Subjects were dosed with approximately 1.0 mg/kg, using ketamine as anesthetic.
16203486|NCT01367119|Drug|methohexital|Subjects were dosed with approximately 1.0 mg/kg, using methohexital as anesthetic.
16203487|NCT01367106|Procedure|Euglycemic hyperinsulinemic clamp|Euglycemic hyperinsulinemic clamp will be performed at day 2
16203488|NCT01367080|Drug|DWETR10|Amitriptyline hydrochloride 10mg(DWETR10) single dose
16203489|NCT01367080|Drug|DWETR25|Amitriptyline hydrochloride 25mg(DWETR25) single dose
16203490|NCT01367054|Drug|Metformin|500 mg tablet
16203491|NCT01367054|Drug|Glifage|500 mg tablet
16203492|NCT01367041|Procedure|vibration|Vibration frequency: 40 Hz, duration: 30+30 s, 2mm amplitude
16203493|NCT01367028|Drug|Trastuzumab, Docetaxel|"6 cycles - Day1 (Day22 = Day1): Trastuzumab: 8 mg/kg loading dose (1st cycle) i.v.; 6 mg/kg maintenance dose in subsequent cycles i.v.
~Docetaxel: 100 mg/m2 by 60 min i.v. infusion"
16203494|NCT01367028|Drug|Trastuzumab, Docetaxel, Bevacizumab|"6 cycles - Day1 (Day22 = Day1): Trastuzumab: 8 mg/kg loading dose (1st cycle) i.v.; 6 mg/kg maintenance dose in subsequent cycles i.v.
~Docetaxel: 100 mg/m2 by 60 min i.v. infusion Bevacizumab 15 mg/kg"
16203495|NCT01367028|Drug|Trastuzumab+Docetaxel+NPLD|"6 cycles - Day1 (Day22=Day1): Trastuzumab: 8 mg/kg loading dose (1st cycle) i.v.; 6 mg/kg maintenance dose in subsequent cycles i.v.
~Docetaxel: 75 mg/m2 by 60 min IV infusion NPLD 50 mg/m2 by 60 min i.v. infusion"
16203496|NCT01367028|Drug|Trastuzumab+Docetaxel+NPLD+Bevacizumab|"6 cycles - Day1 (Day22= Day1): Trastuzumab: 8 mg/kg loading dose (1st cycle) i.v.; 6 mg/kg maintenance dose in subsequent cycles i.v.
~Docetaxel: 75 mg/m2 by 60 min i.v. infusion NPLD: 50 mg/m2 by 60 min i.v. infusion; Bevacizumab 15 mg/kg"
16203497|NCT01367015|Other|Early Feeding|Feeding with expressed breast milk @ 8ml/kg/day for 48 hrs after randomization at 60+/-12 hrs of life
16203498|NCT01367015|Other|Late Feeding|Nil per oral for another 48 hrs after randomization at 60+/-12 hrs of life followed by Feeding with expressed breast milk @ 8ml/kg/day for 48 hrs
16203499|NCT01367002|Drug|Carboplatin/Paclitaxel|Paclitaxel 175 mg/m2 will administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. 100% of patients will receive Carboplatin/Paclitaxel.
16203500|NCT01367002|Drug|Trastuzumab|Paclitaxel 175 mg/m2 will be administered intravenously every 21 days for 6 cycles. Carboplatin AUC 5 will be administered intravenously every 21 days for 6 cycles. On day 1, an 8 mg/kg loading dose of trastuzumab will be administered over a 90 minute period. Beginning on day 21, patients will receive 6mg/kg of trastuzumab, administered intravenously every 21 days and continued indefinitely every 21 days after 6 cycles of cytotoxic therapy are completed and until progression of the disease or prohibitive toxicities occur. 50% of patients will receive Carboplatin/Paclitaxel with the addition of Trastuzumab.
16203501|NCT01366989|Device|Radiographic evaluation of previously implanted patients|Radiographs of the ankle
16203502|NCT01366976|Drug|Acetaminophen|Acetaminophen 1g every 6 hours for 4 doses over 24 hours
16203503|NCT01366963|Behavioral|Seated Measurements|"The following measurements will take place in a seated position:
~Ruff 1 & 7 (visual search and attention processes) Trails A & B (Tests of scanning, mental flexibility and executive processes) Symbol Digit Modalities Test (SDMT)(attention and psychomotor speed) Stroop Test (naming response to certain stimuli) Verbal Fluency (COWA) Randt Wechsler Test of Adult Reading (WTAR)"
16203504|NCT01366963|Behavioral|Standing Measurements|"The following will be measured in a standing position (at least 5 minutes)
~Orthostatic Vital Signs Randt Paired Words Subtest Digits Forward and Backward Alternate COWA test"
16203505|NCT01366963|Behavioral|Self-Administered Surveys|Center for Epidemiologic Studies Depression Scale (CES-D) Cognitive-Somatic Anxiety Questionnaire (CSAQ) Subjective Neurocognitive Inventory (SNI)
16203506|NCT01366950|Behavioral|Intelligent physical activity|30 minutes of moderate activity 6 days a week and 45 minutes of high intensity training 1 day a week. Moderate activity is monitored in diaries and high intensity training is monitored by a trainer.
16203507|NCT01366924|Dietary Supplement|Essential Amino Acids|10 Gram Essential Amino Acid solutions with different leucine contents consumed during two identical endurance exercise trials
16203508|NCT01366924|Other|Endurance exercise|60 minute endurance exercise session
16203509|NCT01366898|Drug|Dexamethasona, Idarubicine, ARA-C, Methotrexate|
16203510|NCT01366885|Drug|Vitamin D3|5000 IU D3 capsule oral/day for entire pregnancy. 7000 IU D3/day during breastfeeding. If not breast feeding, baby gets 400 IU D3/day. Baby increased to 1000 IU D3/day at one year of age.
16203511|NCT01366859|Dietary Supplement|Whey Protein|The experimental study group will consist of thirty children that will be treated with Immunocal® 0.5 g/kg if less than 18 kg of body weight or 10 g/day for those children over 18 kg of body weight for three months to determine the supplement's effect in core areas of behavior in children with autism.
16203512|NCT01366859|Dietary Supplement|Rice Protein (Placebo)|The control or placebo study group will consist of thirty children that will be treated with rice protein (placebo) 0.5 g/kg if less than 18 kg of body weight or 10 g/day for those children over 18 kg of body weight for three months.
16203513|NCT01366846|Other|Avoidance of peanut|All participants will be assigned to peanut avoidance as per United Kingdom (UK) public health recommendations and will avoid exposure to peanut protein during the study until the last study visit when they will receive the Oral Food Challenge.
16203514|NCT01366833|Radiation|Brachytherapy|Patients in arm B will receive a single dose of brachytherapy (10Gy) via a 10 or 13 mm catheter within 10days of stent insertion. Patients on the study will not be given preferential treatment, and will not be prioritized over patients treated with brachytherapy not on the study.
16203515|NCT01366833|Procedure|Stent insertion|After placement of clips to mark the proximal and distal extent of the tumor, an endoscopically placed self-expanding metallic stent (WallFlex™ Partially Covered Esophageal Stent by Boston Scientific) will be inserted within 10 days of recruitment. This will be the only intervention in Arm A patients.
16203516|NCT01366820|Drug|NNZ-2566|"Solution for intravenous infusion.
~Intravenous bolus infusion over 10 minutes followed by a continuous intravenous maintenance infusion for a total of 72 consecutive hours."
16203517|NCT01366820|Drug|Placebo|Sodium Chloride 0.9% Injection
16203518|NCT01366794|Other|Macronutrients|Glucose 330 kcal Protein 110 kcal Fat emulsion 110 kcal Mixed meal 550 kcal
16203519|NCT01366781|Other|Meal ingestion|Meal 511 kcal, meal 743 kcal or meal 1034 kcal
16203520|NCT01366768|Other|Oral amino acid mixture|Amino acid mixture 2,93 ml/kg
16203521|NCT01366768|Other|Intravenous amino acid administration|Amino acid mixture 2,93 ml/kg
16203522|NCT01366729|Device|TheraTogs|Orthosis facilitating hemiplegic hip extensor and abductor activity. Worn daily from dressing in the morning to undressing at night. May be removed during therapy or afternoon sleep.
16203523|NCT01366729|Device|Cane walking|All walking activities must take place with cane from waking until sleeping
16203524|NCT01366716|Behavioral|Cash CM|Participants in the cash CM condition will be assigned to the identical 12-week escalating schedule of reinforcement, except that the contingencies will be provided in cash rather than vouchers, and no negotiation process will be involved (although counselors may recommend how clients might best spend their money).
16203525|NCT01366716|Behavioral|Voucher CM|Participants in the voucher condition will earn voucher incentives according to the schedule developed by Higgins (1993, 1994). It involves a 12-week escalating schedule of reinforcement to initiate cocaine abstinence.
16203526|NCT01366703|Device|implantable loop recorder Medtronic reveal XT Full view|Medtronic Reveal implantable loop recorder with home-monitoring using carelink will be implanted in every patient and used to continuously monitor the patients during follow-up to detect symptomatic and asymptomatic arrythmias during follow-up
16203527|NCT01366690|Behavioral|Peer Support|A trained peer supporter is assigned to support newly HIV-positive diagnosed persons.
16203528|NCT01366677|Behavioral|Yoga Intervention|Three yoga classes per week for 8 weeks.
16203529|NCT01366664|Drug|Treatment sequence 2|Treatment Period 1 (stable dose of terazosin [2, 5, or 10 mg] + placebo administered orally once daily for 5 days) followed up to 14 days later by Treatment Period 2 (stable dose of terazosin [2, 5, or 10 mg] + dapoxetine 60 mg administered orally once daily for 5 days)
16203530|NCT01366664|Drug|Treatment sequence 1|Treatment Period 1 (stable dose of terazosin [2, 5, or 10 mg] + dapoxetine 60 mg administered orally once daily for 5 days) followed up to 14 days later by Treatment Period 2 (stable dose of terazosin [2, 5, or 10 mg] + placebo administered orally once daily for 5 days)
16203531|NCT01366651|Drug|Doripenem|Type=exact number, unit=mg/kg, number=30, form=solution for injection, route=intravenous use, every 8 hours for 2 days (total of 5 doses) for patients 12 weeks to <1 year of age.
16203532|NCT01366651|Drug|Doripenem|Type=exact number, unit=mg/kg, number=10, form=solution for injection, route=intravenous use, every 8 hours for 2 days (total of 5 doses) for patients <12 weeks of age.
16203533|NCT01366638|Drug|TMC435|100 mg capsule taken by mouth once daily for 12 weeks
16203534|NCT01366638|Drug|Peginterferon alfa-2b (pegIFN alfa-2b)|PegIFN alfa-2b will be supplied as a vial containing dried and frozen powder with 74,148 or 222 mcg pegIFN alpha-2b attached to 0.7 ml injection water (50, 100 or 150 mcg/0.5mL pegIFN alpha-2b) and will be administered according to the manufacturer's prescribing information as 1.5 mcg/kg once weekly injected subcutaneous (under the skin) for up to 24-48 weeks.
16203535|NCT01366638|Drug|Ribavirin (RBV)|The dose of RBV given will be based on body weight. If body weight is > 80 kg the total daily dose of RBV will be 1000 mg, taken by mouth as 400 mg (2 capsules of 200 mg) after breakfast and 600 mg (3 capsules of 200 mg) after supper. If body weight is > 60 kg to <=80 kg the total daily dose will be 800 mg, taken by mouth as 400 mg (2 capsules of 200 mg per intake) after breakfast and supper. If body weight is <=60 kg the total daily dose of RBV will be 600 mg, taken by mouth as 200 mg (1 capsule of 200 mg) after breakfast and 400 mg (2 capsules of 200 mg) after supper. Total duration of RBV will be 24-48 weeks.
16203536|NCT01366625|Device|Renal denervation with a catheter-based procedure (Symplicity® Catheter System)|Disruption of the renal nerves with a catheter-based procedure.
16203537|NCT01366612|Drug|Fludarabine and Busulfan plus/minus Total Body Irradiation (low dose)|"Fludarabine 40mg/m2 and Busulfan 130mg/m2 on days -6, -5, -4 and -3 of transplant.
~rATG on days -3, -2 and -1"
16203538|NCT01366612|Drug|Fludarabine and Busulfan + Low Dose Total Body Irradiation (LD TBI)|"Fludarabine 40mg/m2 and Busulfan 130mg/m2 on days -6, -5, -4 and -3 of transplant.
~rATG on days -3, -2 and -1 TBI 200cGY (as randomized) on day -1"
16203539|NCT01366599|Drug|HEC or MEC|Any HEC or MEC, including aprepitant
16203540|NCT01366573|Drug|GSK1521498|GSK1521498 20 mg administered with alcohol to determine PK/PD interactions
16203541|NCT01366573|Other|Placebo|Placebo
16203542|NCT01366560|Drug|Active|GSK962040 125mg
16203543|NCT01366560|Drug|Placebo|Matching Placebo
16203544|NCT01366547|Drug|Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg|Dolutegravir 50 mg/abacavir 600 mg/lamivudine 300 mg is an experimental fixed dose combination tablet of an experimental integrase inhibitor (dolutegravir) and two FDA approved nucleoside reverse transcriptase inhibitors (abacavir and lamivudine)
16203545|NCT01366547|Drug|Dolutegravir 50 mg|Dolutegravir is an experimental drug in the integrase inhibitor class that is being studied for the treatment of HIV infection.
16203546|NCT01366547|Drug|abacavir 600 mg/lamivudine 300 mg|This is an FDA approved fixed dose combination tablet of two nucleoside reverse transcriptase inhibitors
16203547|NCT01366534|Biological|Crucell's replication deficient adenovirus type 35 circumsporozoite malaria vaccine (Ad35.CS.01)|One dose will be administered intramuscularly at Study Day 0.
16203548|NCT01366534|Biological|GSK Biologicals' malaria vaccine 257049 (2 doses)|Two doses will be administered intramuscularly at monthly intervals
16203549|NCT01366534|Biological|GSK Biologicals' malaria vaccine 257049 (3 doses)|Three doses will be administered intramuscularly at monthly intervals
16203550|NCT01366534|Other|Sporozoite challenge|Subjects were challenged with sporozoite-infected mosquitoes to determine whether immune protective response had been induced by vaccination.
16203551|NCT01366521|Biological|Mepolizumab|Monoclonal antibody
16203552|NCT01366508|Other|High calorie lunch|Subject fed a standard high calorie lunch at 1pm
16203553|NCT01366508|Other|Breakfast|At approximately 09:00 the subject will be given breakfast. After this, no food will be served until study procedures for the day are over. However, a 330 ml bottle of still water at room temperature will be given at ~11:00 and at ~13:00. During this period the subject will be required to remain in the unit.
16203554|NCT01366495|Behavioral|Project Bridge|Project Bridge provides intensive case management for individuals with HIV as they transition back into the community from incarceration. The primary goal of the program is to increase continuity of medical care through social stabilization.
16203555|NCT01366482|Device|Cotavance Drug-Eluting Balloon|Treatment with a paclitaxel-coated angioplasty balloon (without preceding plaque excision)
16203556|NCT01366482|Device|TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon|Plaque excision with a SilverHawk or TurboHawk plaque excision device followed by treatment with a paclitaxel-coated angioplasty balloon
16203557|NCT01366482|Device|TurboHawk/SilverHawk + Cotavance Drug-Eluting Balloon|Plaque excision followed by treatment with a paclitaxel-coated angioplasty balloon
16203558|NCT01366456|Device|Moxibustion|Comparison of different kinds of moxibustion
16203559|NCT01366443|Procedure|Sterile speculum exam|Sterile vaginal speculum exam to include Nitrazine, ferning and pooling observations
16203560|NCT01366443|Procedure|ROM Plus Exam|Vaginal swab exam for ROM Plus Test
16203561|NCT01366443|Procedure|Chart Reveiw|Post delivery blinded chart review by expereienced obstetrician
16203614|NCT01366144|Drug|Carboplatin|Given IV
16203615|NCT01366144|Other|Laboratory Biomarker Analysis|Correlative studies
16203616|NCT01366144|Drug|Paclitaxel|Given IV
16203562|NCT01366430|Procedure|Gufoni|For Gufoni maneuver, the patient was quickly brought down on the healthy side from the sitting position, and the head was then turned about 45 degree down, so that the nose was on the bed. After 2 minutes in this position, the patient was returned to the upright position.
16203563|NCT01366430|Procedure|Sham|The sham maneuver the opposite of the first step for barbecue rotation; lying down from sitting position for 30 seconds, and head turn 90degree to the affected side for 1 minute, and then sit up.
16203564|NCT01366430|Procedure|Barbecue|For barbecue rotation, the head was rotated rapidly 90degree while supine in the direction of the healthy ear, which was immediately followed by a truncal rotation of 90degree in the same direction to lie on the intact side. After 30-60 seconds when the induced nystagmus was dissipated, the patients were subjected to a further 90degree rotation of the head and trunk en block in the same direction to attain the nose-down position. After a further 30-60 seconds, the head was again turned in the same direction so that the affected ear was downward. Finally, after another 30-60s, the patient was brought to sitting position. Only one maneuver was performed per session.
16203565|NCT01366417|Drug|ChloraPrep One-Step|1.5 ml applicator patient preoperative skin preparation
16203566|NCT01366417|Drug|70% isopropyl alcohol|Curity Alcohol Prep Pads
16203567|NCT01366391|Drug|Metformin|Metformin 500 mg tablet (1000 or 1500 mg/day)
16203568|NCT01366378|Drug|methylnaltrexone|
16203569|NCT01366365|Drug|methylnaltrexone|
16203570|NCT01366365|Drug|placebo|
16203571|NCT01366352|Drug|MNTX tablet (Formulation 1)|
16203572|NCT01366352|Drug|MNTX tablet (Formulation 2)|
16203573|NCT01366339|Drug|Oral methylnaltrexone|
16203574|NCT01366339|Drug|Oral placebo|
16203575|NCT01366326|Drug|Methylnaltrexone bromide|Subcutaneous MNTX
16203576|NCT01366313|Drug|Paracetamol|initial doses was 1.5g, with dose adjustment intervals of 0.5g . with maximum dose 2.5 g as an only starting dose / 24 h
16203577|NCT01366313|Drug|Morphine|Initial of morphine was 5mg, with dose adjustment intervals 1 mg .
16203578|NCT01366313|Drug|Paracetamol- Morphine|The initial doses of paracetamol and morphine were 1.5g and 3mg, respectively in the paracetamol-morphine combination group with dose adjustment intervals of 0.25g for paracetamol and 0.5mg for morphine.
16203579|NCT01366300|Drug|Intravenous lidocaine infusion|Once the dose of propofol required for general anesthesia is stabilized for 5 minutes with BIS values between 40 and 50, lidocaine 1% infusion is begun in a bolus of 1.5mg/kg for 5 minutes and then infused at 2 mg/kg/hr until the end of surgery (last skin suture is made).
16203580|NCT01366300|Other|Placebo (0.9% saline infusion)|Once the dose of propofol required for general anesthesia is stabilized for 5 minutes with BIS values between 40 and 50, 0.9% saline infusion is begun in a bolus of 1.5mg/kg for 5 minutes and then infused at 2 mg/kg/hr until the end of surgery (last skin suture is made).
16203581|NCT01366300|Drug|Propofol 1% (intravenous infusion)|Propofol is administered according to a widely-accepted pharmacokinetic model, initially dosed to a target controlled infusion (TCI) of 4.5 micrograms/ml, and titrated by step increases of 0.5 every minute until loss of conscience is obtained and BIS values are less than 50. During the maintenance phase of anesthesia propofol TCI is actively titrated to maintain BIS values between 40 and 50. If BIS is out of this range for more than 10 seconds, propofol is adjusted in 0.5 ug/mc to maintain BIS values in the predetermined limits.
16203582|NCT01366300|Procedure|Placement of arterial line|An arterial line was placed in the anesthetised patient´s right arm by the investigator and arterial samples were obtained every 10 minutes since initiation of the study infusion to determine plasmatic lidocaine and propofol levels (if the infusion was saline the samples were not analyzed). The arterial line was removed before the end of surgery.
16203583|NCT01366287|Drug|PF-03882845|25 mg of PF-03882845 suspension (75% SDD) will be given as a single oral dose under fasted condition
16203584|NCT01366287|Drug|PF-03882845|25 mg PF-03882845 Tablet (75% SDD) will be given as a single oral dose under fasted condition
16203585|NCT01366287|Drug|PF-03882845|25 mg PF-03882845 Tablet (75% SDD) will be given as a single oral dose under fed condition
16203586|NCT01366274|Other|Protective manual hyperinflation|Manual hyperinflation for 10 minutes using a Mapleson C circuit and 100% oxygen with volume set at 8mls/kg and positive end expiratory pressure in the circuit appropriate to baseline levels
16203587|NCT01366274|Other|Usual method of MHI|Manual hyperinflation for 10 minutes using a Mapleson C circuit and 100% oxygen with volume set at 12mls/kg and no positive end expiratory pressure in the circuit
16203588|NCT01366261|Device|semirigid thoracoscopy|thoracoscopy with semirigid instrument
16203589|NCT01366261|Device|rigid thoracoscopy|thoracoscopy with rigid instrument
16203590|NCT01366235|Drug|chloroquine phosphate 1000 mg|1000 mg, 1day
16203591|NCT01366222|Dietary Supplement|food concentrates: fruit, vegetable, fish oil and probiotics|comparison the effect of food concentrate
16203592|NCT01366209|Drug|Pirfenidone|Pirfenidone, total daily dose of 2403 mg/ day, given as 3 divided doses 3 times per day.
16203593|NCT01366209|Drug|Placebo|Placebo equivalent given as 3 divided doses 3 times per day.
16203594|NCT01366196|Drug|Pregabalin 150 mg|Patients will receive two 75 mg capsules of pregabalin 1 hour before surgery. They continue to take 2 capsules of 75 mg (total 150 mg) until POD 14.
16203595|NCT01366196|Drug|Placebo|Patients will first receive two capsules of the placebo drug (with no active ingredients per dose) one hour before surgery. Patients will continue taking two capsules per day until POD 14.
16203596|NCT01366183|Procedure|Assessment of Therapy Complications|Undergo nutritional status, such as body mass index and weight loss, and comorbidity and hearing impairment assessments
16203597|NCT01366183|Drug|Carboplatin|Undergo chemotherapy
16203598|NCT01366183|Biological|Filgrastim|Undergo chemotherapy
16203599|NCT01366183|Drug|Paclitaxel|Undergo chemotherapy
16203600|NCT01366183|Other|Pharmacological Study|Correlative studies
16203601|NCT01366183|Other|Quality-of-Life Assessment|Ancillary studies
16203602|NCT01366183|Other|Questionnaire Administration|Ancillary studies
16203603|NCT01366170|Genetic|microarray analysis|
16203604|NCT01366170|Genetic|protein expression analysis|
16203605|NCT01366170|Genetic|western blotting|
16203606|NCT01366170|Other|flow cytometry|
16203607|NCT01366170|Other|immunohistochemistry staining method|
16203617|NCT01366144|Other|Pharmacological Study|Correlative studies
16203618|NCT01366144|Drug|Veliparib|Given PO
16203619|NCT01366131|Drug|MEGF0444A|Intravenous repeating dose
16203620|NCT01366131|Drug|bevacizumab|Intravenous repeating dose
16203621|NCT01366131|Drug|carboplatin|Intravenous repeating dose
16203622|NCT01366131|Drug|paclitaxel|Intravenous repeating dose
16203623|NCT01366131|Drug|placebo|Intravenous repeating dose
16203624|NCT01366118|Drug|Therapeutic target tailored chemotherapy|"All pts were treated with Capecitabine (Cap) 625-825 mg/m2/12h M-F.
~Ch combination schema was customized based on:
~Top- 1 +: Irinotecan (I) 50mg/m2 / in weekly. Top-1 - and ERCC-1 - : Oxaliplatin (O) 50gm/m2/ weekly. Top- 1 - and ERCC-1 + : Neither I nor O. K-Ras or b-Raf mutated (m) : Bevacizumab (B) 5mg/kg every two weeks. K-Ras and B-Raf native (n): Cetuximab (C) 400/250mg/m2 weekly or B (investigator option). Figure 1.
~When Cap was in combination with O or I the 625mg/m2 dose was chosen. When Cap was the only chemotherapy agent in combination with B or C the 825mg/m2 dose was chosen"
16203625|NCT01366105|Device|V.A.C. by K.C.I.|Negative Pressure Wound Therapy, Delivered by Vacuum Assisted Closure (KCI) across closed surgical incision at completion of surgery
16203626|NCT01366092|Drug|Interleukin-2|Daily subcutaneous IL-2 (1 x 10^6 IU/m^2/day) for self-administration for 12 weeks followed by 4-week hiatus
16203627|NCT01366079|Procedure|Position change|Patients change position (cecum to hepatic flexure, left lateral; transverse colon, supine; splenic flexure and descending colon , right lateral) during colonoscopy withdrawal.
16203628|NCT01366079|Procedure|Left lateral|In left lateral position group patients are positioned left lateral decubitus during colonoscopy withdrawal.
16203629|NCT01366066|Device|Transcutaneous mechanical nerve stimulation|"A medical vibrator (FERTI CARE personel, Multicept A/S, Albertslund, Denmark) will be used. The stimulation works through a vibrating disc of hard plastic with a diameter of 3.5 cm. The stimulation point will be the perineum. The stimulation will be performed with a vibration amplitude of 2 mm and a frequency of 100 Hz.
~A daily stimulation sequence consisting of 10 seconds of stimulation followed by a 10 second pause repeated 10 times will be used through 6 weeks."
16203630|NCT01366014|Drug|ARRY-371797, p38 inhibitor; oral|multiple dose, single schedule
16203631|NCT01366014|Drug|Oxycodone hydrochloride (HCl) extended release (ER), opioid agonist; oral|multiple dose, single schedule
16203632|NCT01366014|Drug|Placebo; oral|matching placebo
16203633|NCT01366001|Drug|ALKS 33-BUP|Sublingual administration, ALKS 33 + buprenorphine, administered once daily for 10 consecutive days.
16203634|NCT01366001|Drug|ALKS 33|Sublingual administration, ALKS 33 administered once daily for 10 consecutive days.
16203635|NCT01366001|Drug|Placebo|Sublingual administration, Placebo administered once daily for 10 consecutive days.
16203636|NCT01365962|Genetic|gene expression analysis|
16203637|NCT01365962|Other|immunohistochemistry staining method|
16203638|NCT01365962|Other|laboratory biomarker analysis|
16203639|NCT01365962|Other|mass spectrometry|
16203640|NCT01365949|Genetic|microarray analysis|
16203641|NCT01365949|Genetic|protein analysis|
16203642|NCT01365949|Other|immunohistochemistry staining method|
16203643|NCT01365949|Other|laboratory biomarker analysis|
16203644|NCT01365936|Drug|HMG|In this prospective trial, women with PCOS (according to Rotterdam criteria) were randomized (80 patients) after GnRH analogue suppression to stimulation with HMG (n=38) or rFSH (n=42) using a low dose step up protocol in ICSI cycles.
16203645|NCT01365936|Drug|rFSH|Patients were randomized after GnRH analogue suppression to stimulation with HMG (n=38) or rFSH (n=42) using a low dose step up protocol in ICSI cycles.
16203646|NCT01365923|Drug|remifentanil|remifentanil effect site-TCI 2-4ng/ml
16203647|NCT01365923|Drug|dexmedetomidine with remifentanil|remifentanil effect site-TCI 2-4ng/ml with dexmedetomidine 0.5mcg/kg
16203648|NCT01365910|Drug|linifanib|Given PO
16203649|NCT01365897|Drug|Modafinil|Modafinil 200mg
16203650|NCT01365871|Procedure|anesthetics injection|Basal injection of anesthetics or basal + apical injection of anesthetics.
16203651|NCT01365858|Other|Rehabilitation|"The experimental group patients receive rehabilitation by training Virtual Action Planning - Supermarket on a computer 45 minutes 5 times a week during a 2-week period. The control group will receive similar duration cognitive rehabilitation (no extra computer training) during this period (problem solving and occupational therapy)."
16203652|NCT01365845|Radiation|Photon|50.4 Gy to the breast/chest wall and peripheral lymph nodes at 1.8 Gy per fraction
16203653|NCT01365845|Radiation|3D-Proton/Conventional plan or 3D-proton only|50.4 Cobalt Gray Equivalent/Gray to the breast/chest wall and peripheral lymph nodes at 1.8 Cobalt Gray Equivalent/Gray per fraction
16203654|NCT01365832|Procedure|Continuous Positive Airway Pressure (CPAP)|Continuous positive airway pressure (CPAP) is the gold standard for Obstructive Sleep Apnea (OSA) management. Subjects with OSA will be trained in the use of CPAP and will be instructed to use CPAP every night for 6 months. These subjects will then return for a post-treatment blood draw 3 and 6 months after the start of effective CPAP treatment
16203655|NCT01365819|Drug|Varenicline|Varenicline dosing will follow that which has been shown to be effective for cigarette smoking cessation. Varenicline dose will start at 0.5 mg daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9).
16203656|NCT01365819|Drug|Placebo|Placebo dose will start at 0.5 mg (sugar pill) daily for days 1-3, followed by 0.5 mg twice daily for days 4-7, followed by 1 mg twice daily from day 8 until completion of the medication period (end of week 9).
16203657|NCT01365793|Drug|0.45% saline replacement fluid|10cc/Kg bolus of 0.9% saline followed by 0.45% saline used as the replacement fluid
16203658|NCT01365793|Drug|0.9% saline replacement fluid|10cc/Kg bolus of 0.9% saline followed by 0.9% saline used as the replacement fluid.
16203659|NCT01365793|Drug|0.45% saline intravenous fluid|0.45% saline fluid
16203660|NCT01365793|Drug|0.9% saline Intravenous fluid|0.9% saline fluid
16203661|NCT01365780|Procedure|Hyperbaric Oxygen Therapy|The patients receive 10 sessions of HBOT in two weeks, starting on the day after the surgical treatment of their radius fracture. Each session lasts about one hour.
16203662|NCT01365754|Procedure|standard|fusion
16203663|NCT01365754|Procedure|new|dynamic stabilization
16203664|NCT01365741|Other|Upright position|The test person will ingest Efient in an upright position and remain upright for 2 minutes. After 2 minutes, the test person will lie down, and remain supine for 2 hours, the same way as the person did in the control arm
16203665|NCT01365728|Procedure|LASIK with the iFS femtosecond laser|Patients will undergo bilateral simultaneous LASIK surgery for myopia. One eye will have a LASIK flap created with the Intralase FS60 and the fellow eye will have a LASIK flap created with the Intralase iFS. Both eyes will undergo wavefront-guided LASIK surgery with the Visx CustomVue excimer laser.
16203666|NCT01365715|Procedure|Arteriography and preoperative embolization|Arteriography and transcatheter arterial embolization of spinal metastasis/metastases 0-48 hours prior to surgery.
16203667|NCT01365715|Procedure|Arteriography|Arteriography of spinal metastasis/metastases without transcatheter arterial embolization prior to surgery.
16203668|NCT01365676|Drug|GAMALINE® + HIPERICIN®|GAMALINE® 900mg + HIPERICIN 300mg T0 = 2 soft caps of each / day (1st month) T1-T6 = 1 soft caps of each / day (2nd - 6th month)
16203669|NCT01365676|Drug|GAMALINE®|GAMALINE® 900mg T0= 2 soft caps / day (1st month) T1-T6 = 1 soft caps / day (2nd - 6th month)
16203670|NCT01365663|Drug|SPC4955|3 Weekly SC injections
16203671|NCT01365663|Drug|SPC4955|3 Weekly SC injections
16203672|NCT01365663|Drug|SPC4955|3 Weekly SC injections
16203673|NCT01365663|Drug|SPC4955|3 Weekly SC injections
16203674|NCT01365663|Drug|SPC4955|3 Weekly SC injections
16203675|NCT01365663|Drug|Saline 0.9%|3 Weekly SC injections
16203676|NCT01365650|Drug|Ketorolac Tromethamine|Single intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on Day 1 of Period 1
16203677|NCT01365650|Drug|Oxymetazoline Hydrochloride|Single intranasal dose of oxymetazoline hydrochloride followed by a single intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) 30 minutes later on Day 1 of Period 2
16203678|NCT01365650|Drug|Fluticasone Propionate|Seven days of treatment with intranasal fluticasone propionate (between Periods 2 and 3) followed by a single intranasal dose of 30 mg ketorolac tromethamine (one 15 mg spray into each nostril) on Day 1 of Period 3
16203679|NCT01365637|Drug|PF-05089771|PF-05089771 will be dosed as a suspension twice daily
16203680|NCT01365637|Drug|PF-05089771|PF-05089771 will be dosed as a suspension twice daily
16203681|NCT01365637|Drug|PF-05089771|PF-05089771 will be dosed as a suspension either twice or thrice daily
16203682|NCT01365637|Drug|PF-05089771|PF-05089771 will be dosed as a suspension either twice or thrice daily
16203683|NCT01365624|Drug|Ketorolac tromethamine|Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)
16203684|NCT01365611|Drug|Ketorolac tromethamine|A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6.
16203685|NCT01365611|Drug|Fluticasone Propionate|Daily intranasal dose of 200 ug fluticasone propionate on Days 2-6
16203686|NCT01365598|Drug|Primaquine|Single dose of oral primaquine phosphate. Comparator dose is 0.75mg/kg primaquine base. Each experimental arm is a different (reduced) dose of primaquine phosphate. Placebo contains no primaquine phosphate (non-active ingredients only).
16203687|NCT01365585|Drug|sildenafil citrate|Sildenafil citrate, 20mg oral tablets, taken at least three times daily
16203688|NCT01365572|Device|Xiene V stent, Endeavor Resolute stent|for each lesion, randomized either Xience V stent or Endeavor Resolute stent
16203689|NCT01365559|Drug|Group A: Carfilzomib & Non-IMiD Regimen|"Carfilzomib will be administered intravenously starting at a dose of 20 mg/m^2 over 30 minutes for the first cycle and will then be increased to 27, 36 and 45 mg/m2 during cycles 2-4, respectively. Doses will be administered IV once daily on days 1, 2, 8, 9, 15, and 16 of each cycle. Cycles will be 28 days in length.
~Combination non-IMiD drug is dosed on the identical schedule and dosage as patient was in previous bortezomib containing regimen.
~Maintenance regimen maybe administered if patient does not progress while on study."
16203690|NCT01365559|Drug|Group B: Carfilzomib & IMiD containing regimen.|"Carfilzomib will be administered intravenously starting at a dose of 20 mg/m^2 over 30 minutes for the first cycle and will then be increased to 27, 36 and 45 mg/m2 during cycles 2-4, respectively. Doses will be administered IV once daily on days 1, 2, 8, 9, 15, and 16 of each cycle. Cycles will be 28 days in length.
~Combination IMiD drug is dosed on the identical schedule and dosage as patient was in previous bortezomib containing regimen.
~Maintenance regimen maybe administered if patient does not progress while on study."
16203691|NCT01365546|Biological|human VWF/FVIII concentrate|intravenous infusion. Dose based on subject's individual invivo-recovery
16203692|NCT01365533|Drug|Roflumilast|Roflumilast 500 μg, one tablet once daily, orally
16203693|NCT01365533|Drug|Placebo|Placebo, one tablet once daily, orally
16203694|NCT01365520|Drug|turoctocog alfa|A single dose will be administered i.v. (into the vein). Subjects will be randomised to one of two lots of NNC 0155-0000-0004.
16203695|NCT01365507|Drug|insulin degludec/insulin aspart|Insulin degludec/insulin aspart injected subcutaneously (under the skin) once daily. Dose individually adjusted.
16203696|NCT01365494|Biological|Purified Chick Embryo Cell Inactivated Rabies Vaccine|Two group (Zagreb and Essen) will receive Rabipur vaccine IM according to either Zagreb or Essen schedules.
16203697|NCT01365481|Drug|Valsartan|week 1: 40/80/160 week 2-78: 80/160/320mg, oral, by mouth, once daily
16203698|NCT01365481|Drug|amlodipine|added to valsartan after week 8 if the MSSBP and/or MSDBP was higher than 95th percentile for age, gender and height under the maintenance valsartan dose
16203699|NCT01365481|Drug|Hydrochlorothiazide|added to valsartan after week 8 if the MSSBP and/or MSDBP was higher than 95th percentile for age, gender and height under the maintenance valsartan dose
16203700|NCT01365468|Drug|Everolimus (RAD001)|oral daily dosing of tablet starting with 2.5 mg
16203701|NCT01365455|Drug|secukinumab 150 mg|secukinumab (AIN457) 150mg or 300mg subcutaneous
16203702|NCT01365455|Drug|placebo to secukinumab 150 mg|Placebo to Match secukinumab (AIN457) 150mg or 300mg subcutaneous
16203744|NCT01365156|Procedure|Extraperitoneal laparoscopic lymphadenectomy (EPLND)|Laparoscopic surgical procedure to remove and examine lymph nodes in abdomen, 7-10 days before chemoradiation treatment
16203745|NCT01365156|Radiation|Chemoradiation|Radiation for 5 days in a row for 5 to 5½ weeks plus Cisplatin Chemotherapy cisplatin chemotherapy by vein over about 2 hours, 1 time every week for about 6 weeks.
16203746|NCT01365143|Procedure|Robotic Radical Prostatectomy|Robotic assisted radical prostatectomy
16203703|NCT01365429|Device|XPS™ with Steen Solution™|The XPS™ System is an integrated cardiac bypass system comprised of various components such as a Maquet CardioHelp centrifugal pump (K102726), the HicoVariotherm Heater/Cooler, the Hamilton C2 ICU (intensive care unit) pressure- controlled ventilator (K092148), the perfusate gas monitors, and the display monitors. The XPS™ System is responsible for housing the organ for preservation, providing the normothermic environment, and perfusing the organ with the STEEN Solution™. Donor lungs that meet inclusion criteria are placed on the XPS™ and rewarmed and perfused with STEEN Solution™ and ventilated for 3-6 hours. If the lungs meet transplant suitability, they are cooled down and transplanted into a consented recipient that meet's trial criteria.
16203704|NCT01365403|Drug|RO4917838|Single oral dose, Day 1 of study period 1 and Day 16 of study period 2
16203705|NCT01365403|Drug|carbamazepine|multiple oral doses, Days 1-24 of study period 2
16203706|NCT01365390|Other|Data collection (Retrospective)|For the retrospective part of the study, the parent(s)/ legally acceptable representative(s) of the subjects will be interviewed to collect information on factors potentially related to risk for middle ear diseases. The medical records of the subjects will also be reviewed and all acute otitis media related problems that occurred during the last year prior to enrolment (for subjects aged 1 to < 6 years) or since birth (for subjects aged < 1 year) will be recorded in the electronic case report form.
16203707|NCT01365390|Other|Data collection (Prospective)|For the prospective part of the study, the enrolled subjects will be followed up for a period of 1 year starting from the consent date, during which the parent(s)/ legally acceptable representative(s) will be asked to bring the subject for a visit each time they notice symptoms of acute otitis media or respiratory tract infection in the subject. In case AOM is diagnosed by the investigator, detailed information on the signs, symptoms, severity, course and treatment will be recorded. The parent(s)/ legally acceptable representative(s) of the subjects will also be required to fill up a parental quality of life questionnaire and an Otitis Media-6 children's quality of life questionnaire.
16203708|NCT01365377|Other|booklet deliverance and use in the process of daily information|The brochure shows with text and pictures the day-living of the ICU ; Medical and para-medical staff and organization, the devices, complications and treatment
16203709|NCT01365364|Behavioral|Aerobic Physical Exercise|All individuals were submitted to physical exercise reaching maximum effort
16203710|NCT01365364|Behavioral|Aerobic Physical Exercise|All individuals were submitted to physical exercise reaching maximum effort
16203711|NCT01365351|Other|Growth hormone|Drug given by prescription
16203712|NCT01365338|Drug|Placebo|Administered as specified in the treatment arm
16203713|NCT01365338|Drug|PF-04958242|Administered as specified in the treatment arm
16203714|NCT01365325|Other|handled echocardiography in home monitoring program|home monitoring with clinical evaluations and ECG every three months and echocardiography examinations at the 6th, 12th and 18th month
16203715|NCT01365325|Other|ecg and clinical evaluation in home monitoring program|home monitoring with clinical evaluations and ECG every three months
16203716|NCT01365312|Drug|Ethanol lock|Placement of 0.5 cc 70% ethanol, every 72 hours, for 15 minutes, into PICC lines randomized to ethanol intervention
16203717|NCT01365312|Drug|Heparinized saline|0.5 cc heparinized saline to be placed once every 72 hours for 15 minutes, in PICC lines randomized to placebo
16203718|NCT01365286|Drug|Ivabradine (Procoralan)|Ivabradine 7,5 mg b.i.d. for 5 days and Placebo b.i.d. for 5 days (Ivabradine-Placebo)
16203719|NCT01365286|Drug|Placebo|Placebo b.i.d. for 5 days and Ivabradine 7,5 mg b.i.d. for 5 days (Placebo-Ivabradine)
16203720|NCT01365273|Device|Mepitel One|Dressing
16203721|NCT01365260|Device|MM-II|Single intraarticular (knee) injection of MM-II
16203722|NCT01365260|Device|DurolaneTM|Single intraarticular (knee) injection of DurolaneTM
16203723|NCT01365247|Behavioral|Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure|A manualized, twelve-week intervention applying cognitive-behavioral strategies and prolonged exposure (PE) techniques to address substance use and trauma related issues.
16203724|NCT01365247|Behavioral|Relapse Prevention Treatment|Relapse Prevention Treatment is a cognitive-behavioral skills training approach to initiating and maintaining substance use-related goals.
16203725|NCT01365247|Behavioral|Active Monitoring Control Group|Participants meet with study staff on a weekly basis for the self-monitoring of PTSD and SUD symptoms. Visits consists of self-report assessments, urine toxicology, and a brief check-in with staff to confirm general health and safety.
16203726|NCT01365234|Device|Pacing Lead|Implant and follow up of Model 20066 lead
16203727|NCT01365221|Drug|Prasugrel|Patients who have received 600 mg loading dose of clopidogrel will receive a reloading dose of 60 mg prasugrel
16203728|NCT01365221|Drug|Prasugrel|Patients who have not received a loading dose of clopidogrel will receive a 60 mg loading dose of prasugrel.
16203729|NCT01365208|Drug|Chemotherapy|platinum-based chemotherapy
16203730|NCT01365195|Drug|Placebo|Loading and Infusion: Saline at infusion rate calculated and adjusted for weight to match ketamine bolus-infusion rate
16203731|NCT01365195|Drug|Ketamine high-dose|Loading: 1 mg/Kg Infusion: 10 mcg/kg/min
16203732|NCT01365195|Drug|Ketamine low-dose|Loading: 0.5 mg/Kg Infusion: 5 mcg/kg/min
16203733|NCT01365182|Behavioral|BF+SUPPORT|A session of biofeedback-assisted pelvic floor muscle exercises (PFME) plus 6 group sessions of the Problem-Solving Therapy (teaching self-management skills).
16203734|NCT01365182|Behavioral|BF+PHONE|A session of biofeedback-assisted pelvic floor muscle exercises (PFME) plus 6 telephone sessions of the Problem-Solving Therapy (teaching self-management skills).
16203747|NCT01365143|Procedure|Open Radical Prostatectomy|Open radical prostatectomy
16203748|NCT01365130|Drug|jevtana|Cabazitaxel 25mg/m2, IV every 21 days until progression
16203749|NCT01365117|Drug|Technosphere® Insulin Inhalation Powder|15 subjects in a three-way crossover (three different doses of TI Inhalation Powder [one 20 U, two 20 U and one 40 U cartridges)
16203750|NCT01365117|Drug|Technosphere® Insulin Inhalation Powder|16 subjects in a four-way crossover (four different doses of TI Inhalation Powder [one 20 U, one 20 U plus one 10U, one 30 U (3 U per mg), one 30 U (4 U per mg cartridges)])
16203751|NCT01365104|Drug|desferrioxamine|intravenous infusion at 10mg/kg/hr for a total of 6 hours at final infused doses of 60mg/kg.
16203752|NCT01365091|Drug|Saxagliptin/metformin fixed-dose combination (FDC)|Tablet, oral, 5 mg/500 mg FDC, once on Day 1 only, 1 day
16203753|NCT01365091|Drug|Saxagliptin|Tablet, oral, 5 mg, once on Day 1 only, 1 day
16203754|NCT01365091|Drug|Metformin extended-release (XR)|Tablet, oral, 500 mg, once on Day 1 only, 1 day
16203755|NCT01365091|Drug|Saxagliptin/Metformin FDC|Tablet, Oral, 5 mg/1000 mg FDC, once on Day 1 only, 1 day
16203756|NCT01365091|Drug|Metformin|Tablet, oral, 1000 mg, once on Day 1 only, 1 day
16203757|NCT01365078|Dietary Supplement|Echium oil (SDA-rich oil)|The echium oil will be provided in sachets containing 5 g of oil, and should be taken for six weeks during the experimental period twice a day, i.e. one sachet at lunch and one sachet at dinner
16203758|NCT01365078|Dietary Supplement|high-oleic acid sunflower oil (HOSO) (low in SDA)|The HOSO will be provided in sachets containing 5 g of oil, and should be taken for six weeks during the control period twice a day, i.e. one sachet at lunch and one sachet at dinner
16203759|NCT01365065|Drug|Vorinostat|Vorinostat 400mg (4 x 100mg) orally daily for 14 days
16203760|NCT01365052|Drug|Naproxen sodium 440 mg/DPH 50 mg (BAY98-7111)|2 capsules each containing naproxen sodium 220 mg /diphenhydramine hydrochloride (DPH) 25 mg are taken orally with a full glass of water approximately 30 minutes prior to bedtime for 10 consecutive days
16203761|NCT01365052|Drug|Placebo|2 placebo capsules are taken orally with a full glass of water 30 minutes prior to bedtime for 10 consecutive days
16203762|NCT01365039|Device|Test, daily disposable contact lens|Test lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.
16203763|NCT01365039|Device|SofLens daily disposable contact lens|Control lenses will be worn on a daily disposable wear basis. New study lenses will be dispensed at the Screening/Dispensing, 1-Month, and 2-Month Follow-up Visits in sufficient quantities to maintain a daily disposable wear modality.
16203764|NCT01365026|Behavioral|PVS: Programa de Vida Saludable|Lifestyle counseling and prescription
16203765|NCT01365013|Behavioral|DE-PLAN|structured group or individual educational sessions (4 to 5) on diet and physical activity, plus ongoing reminder contacts (e-mails, sms, etc) during 1 year
16203766|NCT01365013|Behavioral|Control group|Standard advice for lifestyle change
16203767|NCT01365000|Drug|NKTR118 Formulation 1|Oral dose, 25 mg
16203768|NCT01365000|Drug|NKTR118 Formulation 2|Oral dose, 25 mg
16203769|NCT01365000|Drug|NKTR118 Formulation 3|Oral dose, 25 mg
16203770|NCT01365000|Drug|NKTR118 Formulation 1a|Oral dose, 25 mg
16203771|NCT01365000|Drug|NKTR118 Formulation 3a|Oral dose, 25 mg
16203772|NCT01364987|Drug|ASP015K|oral
16203773|NCT01364987|Drug|Mycophenolate Mofetil|oral
16203774|NCT01364974|Drug|ASP015K|oral
16203775|NCT01364974|Drug|Placebo|oral
16203776|NCT01364961|Dietary Supplement|Resveratrol capsules|2 x 75 mg resveratrol each day, for 4 weeks
16203777|NCT01364948|Other|Coconut oil application|Four ml coconut oil application twice daily for first week
16203778|NCT01364948|Other|No oil application|Oil application was not done
16203779|NCT01364922|Drug|hydrocodone/acetaminophen extended release|
16203780|NCT01364922|Drug|Placebo|
16203781|NCT01364909|Other|Exercise|"The subjects will be given 2 x 30 minute sessions of exercise per day consisting of either passive, active, active assisted depending on level of sedation and stability of condition.
~According to level of sedation and stability they may also perform sitting exercises"
16203782|NCT01364909|Other|Usual practice|These patients will not receive exercise early in their intensive care admission
16203783|NCT01364896|Procedure|Venous blood samples, anal swab samples, vaginal swab samples, high resolution anoscopy (HRA), anal biopsy samples|"Before and at least 6 months after starting a new non-steroid immunosuppressive agent for IBD treatment, eligible participants who are attending for routine colonoscopy will have:
~Anal swab samples (and vaginal swab samples for female participants) for human papillomavirus PCR typing (6, 11, 16, 18, 31, 33, 45, 52, 58)
~High-resolution anoscopy and biopsy of all visible high-grade dysplastic lesions based on validated colposcopic criteria
~Anal cytology testing"
16203784|NCT01364883|Biological|Vaccination Schedule One|Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP
16203785|NCT01364883|Biological|Vaccination Schedule Two|Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP
16203786|NCT01364883|Biological|Vaccination Schedule Three|Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP
16203787|NCT01364883|Biological|Vaccination Schedule Four|Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP
16203788|NCT01364883|Biological|Vaccination Schedule Five|Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP
16203789|NCT01364883|Biological|Vaccination Schedule Six|Intramuscular injection of 5x10^10 vp of AdCh63 ME-TRAP, intramuscular injection of 2x10^8 pfu of MVA ME-TRAP
16203790|NCT01364883|Biological|Vaccination Schedule Seven|AdCh63 ME-TRAP prime D0, AdCh63 ME-TRAP boost W8, AdCh63 ME-TRAP boost W16, MVA ME-TRAP boost W24
16203829|NCT01364571|Biological|SA4Ag vaccine high dose|Subjects receive 1 intramuscular injection (0.5 mL) of the high dose level of the SA4Ag vaccine.
16203830|NCT01364571|Procedure|Blood draw|Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.
16203791|NCT01364870|Device|Placebo TENS|"Subjects randomized to the placebo group will use an EMPI TENS Select device that emits a current for 45 seconds then shuts off. They will be asked when they first feel the current, then the device will be turned down a half-point to provide treatment at a sub-sensory level. This unit displays an active indicator light suggesting to the subject that the unit is actively emitting current. At discharge, subject will be sent home with an adequate supply of batteries and asked to change batteries when the device goes below 4 bars, further suggesting that the device is actively working."
16203792|NCT01364870|Device|Active TENS|High-frequency intense TENS provided with the EMPI Select TENS. The generator emits a balanced, asymmetrical, biphasic waveform and has buttons for variation of frequency and amplitude. A rate modulation frequency of 50pps and 150pps every 0.5 seconds will be used with a pulse width of 150 microseconds (μs).
16203793|NCT01364857|Genetic|search for polymorphisms of RASA1 gene|Blood sample ( 5 mL) at tne inclusion of the child DNA extraction and genetic analysis of the 24 exons of RASA1 gene after specific consent
16203794|NCT01364844|Drug|DS-7423|oral capsule 1mg, 8mg, 48mg, and 80mg strengths administered once daily
16203795|NCT01364831|Behavioral|Sleep extension|Athletic performance evaluated at baseline and following about 1.5 hours of sleep extension
16203796|NCT01364805|Drug|Intravenous Vitamin C|The first 5 study visits will all take place in the General Clinical Research Center (GCRC). During these visits you will receive IV doses of Vitamin C. The dose of Vitamin C will be started at 25 grams and may be increased up to 125 grams over a two week period. There may be changes in the amount of Vitamin C that you receive based on your blood test levels. The study staff will go over this in more detail with you. The amount of fluid you receive depends on the dose and can be from 2 1/3 cups to 5 cups.
16203797|NCT01364805|Drug|Gemcitabine|Participants receive dexamethasone 10 mg as pretreatment antiemetic; may be given ondansetron, granisetron, or dolasetron, per oncologist. Gemcitibane 1,000mg/m2 IV over 30 minutes Q 21 days. Cycle of treatment: infusions once weekly for 2 consecutive weeks followed by 1 week of rest to continue treatment schedule until they experience disease progression or unacceptable toxicity. CR, PR or SD: treatment will be continued for at least 6 cycles. Discontinuation of therapy may be considered if agreed upon by the participant and oncologist. Dose Modifications: If the patient experiences more than one toxicity, each requiring a dose reduction, follow the guidelines that give the largest dose reduction for the drug. Subsequent doses can be adjusted to as low as 500 mg/m2 for gemcitabine.
16203798|NCT01364792|Drug|Valaciclovir|4 times 2 grams valaciclovir per day, administrated orally, for seven days.
16203799|NCT01364740|Device|PMP-300E|Data collected from Level 3 device
16203800|NCT01364740|Device|In-lab PSG|Data collected from Type I In-Lab Polysomnography
16203801|NCT01364727|Drug|Amrubicin|35 mg/m2; IV on days 1-3 each 3 week cycle
16203802|NCT01364701|Drug|Sildenafil 100 mg|4 tablets for on demand use
16203803|NCT01364701|Drug|Tadalafil 20 mg|4 tablets on demand
16203804|NCT01364701|Drug|Combination half of maximal dose for sildenafil & tadalafil|4 tablets on demand
16203805|NCT01364688|Drug|oral alfacalcidol|Oral alfacalcidol 0.5 microgram per day
16203806|NCT01364688|Drug|no drug|no drug
16203807|NCT01364675|Drug|Metformin+Enalapril+Simvastatin|Poly-pill - composed of Metformin (500 mg), Enalapril (10 mg) and Simvastatin (10 mg) in single tablet given once daily after dinner for 4 years
16203808|NCT01364675|Drug|Placebo tablet|Identical Placebo Tablet
16203809|NCT01364662|Drug|SPN-810|administered orally
16203810|NCT01364662|Drug|Placebo|administered orally
16203811|NCT01364649|Drug|Vortioxetine|Vortioxetine tablets
16203812|NCT01364649|Drug|Escitalopram|Escitalopram tablets
16203813|NCT01364649|Drug|Placebo|Vortioxetine Placebo-matching capsules
16203814|NCT01364623|Drug|Low dose testosterone nasal gel, single dose|Low dose testosterone nasal gel, single dose
16203815|NCT01364623|Drug|Medium dose testosterone nasal gel, single dose|Medium dose testosterone nasal gel, single dose
16203816|NCT01364623|Drug|High dose testosterone nasal gel, single dose|High dose testosterone nasal gel, single dose
16203817|NCT01364623|Drug|Medium dose testosterone nasal gel, multiple dose|Medium dose testosterone nasal gel, multiple dose
16203818|NCT01364610|Device|Bravo|Bravo pH Monitoring System sited manometrically.
16203819|NCT01364610|Device|Standard Care|Nasally passed pH catheter sited by manometry, accompanied by battery powered data logger. Participant activated event marker in response to symptoms, meals and body position changes.
16203820|NCT01364597|Drug|Brivaracetam (BRV)|The max BRV dose will be 5.0 mg/kg/day, not to exceed a dose of 200 mg/day for subjects with body weight >40kg. Subjects may receive oral solution or oral tablets. The LTFU subjects will start dosing in N01266 on the individualized BRV dose they were receiving at the completion of the core study. Subjects must be able to tolerate the min BRV dose specified in the core study to be eligible for entry into the Evaluation Period of N01266. Dose can be adjusted as considered necessary by the Investigator and required by the subject's medical condition. All subjects who prematurely discontinue the study should complete an EDV and have their BRV dose down titrated by a maximum of half the dose every week for a maximum of 4 weeks until a dose of 1 mg/kg/day (50 mg/day for subjects with body weights >50kg) is reached.
16203821|NCT01364584|Drug|Exenatide|Subcutaneous injection 2.5 micrograms (mcg) to 10 mcg twice per day (BID)
16203822|NCT01364584|Drug|Placebo|Subcutaneous injection 2.5 mcg-10 mcg BID
16203823|NCT01364571|Biological|SA4Ag vaccine low dose|Subjects receive 1 intramuscular injection (0.5 mL) of the low dose level of the SA4Ag vaccine.
16203824|NCT01364571|Procedure|Blood draw|Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.
16203825|NCT01364571|Procedure|Colonization swab sample|Colonization swabs will be collected from all subjects at various time points throughout the study.
16203826|NCT01364571|Biological|SA4Ag vaccine mid dose|Subjects receive 1 intramuscular injection (0.5 mL) of the mid dose level of the SA4Ag vaccine.
16203827|NCT01364571|Procedure|Blood sample|Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.
16203828|NCT01364571|Procedure|Colonization swab sample|Colonization swabs will be collected from all subjects at various time points throughout the study.
16203831|NCT01364571|Procedure|Colonization swab sample|Colonization swabs will be collected from all subjects at various time points throughout the study.
16203832|NCT01364571|Biological|Placebo|Subjects receive one intramuscular injection (0.5 mL) of commercially available normal saline.
16203833|NCT01364571|Procedure|Blood draw|Blood for hematology, coagulation and blood chemistry will be collected at a minimum of 3 timepoints from Phase 1 subjects. Blood for immunogenicity will be collected from all subjects at various timepoints.
16203834|NCT01364571|Procedure|Colonization swab sample|Colonization swabs will be collected from all subjects at various time points throughout the study.
16203835|NCT01364558|Drug|Diazepam|Diazepam will be administered as a 5 mg dose given IV. The two nasal formulations will be given as a 10 mg dose.
16203836|NCT01364558|Drug|Diazepam|IV diazepam will be given as a 5 mg dose. The two nasal formulations will be given as 10 mg doses.
16203837|NCT01364545|Dietary Supplement|Ketone ester drink|Ketone drink - milligram per kilogram dose, consumed three times daily (at meal times)
16203838|NCT01364545|Dietary Supplement|Placebo (carbohydrate containing) drink|Placebo drink - containing carbohydrates, matched in calories to ketone, consumed three times daily
16203839|NCT01364532|Procedure|Transulnar arterial access|Transulnar arterial access in coronary angiography, ad-hoc or elective PCI
16203840|NCT01364532|Procedure|Transradial arterial access|Transradial arterial access for coronary angiography,ad-hoc or elective PCI
16203841|NCT01364519|Drug|Fluticasone Propionate|Dry powder for inhalation, Single Dose, 500mcg
16203842|NCT01364519|Drug|Placebo for Fluticasone Propionate|Dry powder for inhalation, Single Dose, placebo
16203843|NCT01364506|Other|Water aerobic exercise|"The hydrotherapy program of Prevedel et al.14 was used. One-hour sessions, led by a physiotherapist under the supervision of an obstetrician, were held three times a week in an indoor swimming-pool heated at 28oC-32oC, and consisted of exercises of moderate intensity (60-70% of maximum heart rate). Subgroups of up to 10 subjects participated in each session. Sessions were offered at different times of the day (morning, afternoon, and evening).
~The exercises included 5 phases: stretching, warm up, endurance training, strength training and relaxation with breathing exercises, in accordance with the recommendations of ACOG11."
16203844|NCT01364493|Drug|Trastuzumab+Capecitabine+Oxaliplatin|"Trastuzumab will be administered at a loading dose of 8 mg/kg (on day 1) followed by 6mg/kg i.v. infusion every 3 weeks.
~Capecitabine 2000mg/m2d, d1-14; q3w, Trastuzumab and capecitabine are to be continued until disease progression or intolerable toxicity.
~Oxaliplatin 130mg/m2 d1; q3w, 6 cycles"
16203845|NCT01364480|Device|Implantation of NeuroPort Arrays in the motor cortex|Two Blackrock Microsystems NeuroPort Arrays will be implanted in the motor cortex of study participants.
16203846|NCT01364467|Drug|Placebo|Children aged 7-11 years old will receive placebo 200 mg three times a day (TID), while children older than 12 will receive Placebo 400 mg TID.
16203847|NCT01364467|Drug|Guaifenesin|Children aged 7-11 years old will receive guaifenesin 200 mg TID, while children older than 12 will receive guaifenesin 400 mg TID.
16203848|NCT01364454|Other|Eligible patients' paper-based reminder|Providing to the general practitioners every four months a list of their patients who are eligible for colorectal cancer screening but did not proceed yet and were not excluded for medical reason
16203849|NCT01364441|Drug|ONO-2952|3 mg to 800 mg at a single dose; 10 mg and 200 mg for food effect study
16203850|NCT01364441|Drug|Placebo|Placebo dosed in the same manner as ONO-2952
16203851|NCT01364428|Drug|insulin degludec|"Injected subcutaneously (under the skin) once daily, in combination with unchanged pre-trial oral anti-diabetic drug (OAD) treatment.
~Dose was individually adjusted."
16203852|NCT01364428|Drug|insulin degludec|"Injected subcutaneously (under the skin) once daily, in combination with unchanged pre-trial oral anti-diabetic drug (OAD) treatment.
~Dose was individually adjusted."
16203853|NCT01364415|Drug|Pasireotide LAR|
16203854|NCT01364402|Drug|Epoetin beta|50,000U intravenously
16203855|NCT01364402|Drug|Saline 0.9%|normal saline intravenously
16203856|NCT01364389|Drug|AIN457|3 mg/kg
16203857|NCT01364389|Drug|ACZ885|3 mg/kg
16203858|NCT01364389|Drug|Prednisone|20 mg
16203859|NCT01364389|Drug|Placebo|Matching placebo to AIN457, ACZ885 and prednisone
16203860|NCT01364376|Drug|S-1; Oxaliplatin; 5-Fu; Leucovorin Calcium|"FOLFOX:
~oxaliplatin 130mg/m2 on day 1, CF 400mg/m2 on day 1, 5-Fu 400mg/m2 on day 1; 5-FU 2400 mg/m2 46hr civ regimen repeated every 3 weeks Pre-operative chemotherapy: 2-4 cycles and peri-operative chemotherapy consist of 6 cycles
~SOX:
~oxaliplatin 130mg/m2 on day 1, S-1 for 14 days regimen repeated every 3 weeks Pre-chemotherapy: 2-4 cycles, totally 6 cycles of perioperative chemotherapy"
16203861|NCT01364363|Procedure|Allogeneic transplantation|Allogeneic transplantation with matched unrelated donors
16203862|NCT01364350|Other|standard of care in general clinical practice|Participants consenting to receive study-provided care may be treated with metformin, insulin, statin, and ace-inhibitor, as needed for glycemic control and for comorbid conditions.
16203863|NCT01364337|Other|DASH diet|DASH diet: A diet rich in whole grain, fruit and vegetable, low-fat dairy products, white meat and nuts; and lower of total fat and saturated fat.
16203864|NCT01364337|Other|lower carbohydrate DASH diet|lower carbohydrate DASH diet: A DASH diet with lower carbohydrate percentage
16203865|NCT01364324|Drug|standard first line anti-TB drugs|We will perform pharmacokinetic study in gastrectomy and non-gastrectomy group, to evaluate the effect of gastrectomy on pharmacokinetic profile of first-line anti-TB drugs in patients with TB
16203866|NCT01364311|Dietary Supplement|Vitamac® Tag and Nacht capsules|"Vitamac® Tag und Nacht Kapseln: Dosage 1 capsule Vitamac® Tag per day ingested in the morning, 1 capsule Vitamac® Nacht per day ingested in the evening.
~Vitamac® Tag: Lutein 12mg, Vitamin C 300mg, Zinc 10mg, ginkgo biloba 10mg, Flavinoids 25mg, Fishoil 300mg, administered for 12 weeks Vitamac® Nacht: Zeaxanthin 5mg, Vitamin E 60mg, Copper 1mg, Selen 20µg, Ginkgo Biloba 10mg, Flavinoids 25mg, Alpha Lipon acid 150mg), administered for 12 weeks"
16203915|NCT01363869|Dietary Supplement|green tea extracts 4 gm/day|"Green tea extracts capsule (1 gm per capsule), taken after meal, twice daily for 14 days.
~Total dosage is 4 grams per day."
16203916|NCT01363869|Dietary Supplement|green tea extracts 6 gm/day|"Green tea extracts capsule (1 gm per capsule), taken after meal, twice daily for 14 days.
~Total dosage is 6 grams per day."
16203917|NCT01363843|Drug|FOLFOX6|FOLFOX6
16203918|NCT01363843|Radiation|RT with concurrent chemotherapy|IMRT 50.4Gy with chemotherapy
16203867|NCT01364298|Drug|Gabapentin/B-complex|Gabapentin/B-complex (Gavindo®) tablet will be administered orally at an initial dose of 300 milligram per day (mg/day) on Day 1, followed by 600 mg/day (one 300 milligram [mg] tablet every 12-hour) on Day 2, then 900 mg/day (one 300 mg tablet every 8-hour) on Day 7, then 1800 mg/day (two 300 mg tablets every 8-hour) on Day 21, then 2700 mg/day (three 300 mg tablets every 8-hour) on Day 35, and finally 3600 mg/day (four 300 mg tablets every 8-hour) on Days 56 and 84. Maximum dose allowed will be 3600 mg/day. The total duration of treatment will be 84 days (12 weeks).
16203868|NCT01364298|Drug|Pregabalin|Pregabalin (Lyrica®) capsule will be administered orally at an initial dose of 150 mg/day (one 75 mg capsule every 12-hour) from Day 1 to 7, followed by 300 mg/day (one 150 mg capsule every 12-hour) on Day 7, then 600 mg/day (two 150 mg capsule every 12-hour) on Days 21, 35, 56 and 84. Maximum dose allowed will be 600 mg/day. The total duration of treatment will be 84 days (12 weeks).
16203869|NCT01364259|Drug|Amifostine|Amifostine and CyberKnife stereotactic radiosurgery
16203870|NCT01364259|Procedure|CyberKnife stereotactic radiosurgery|CyberKnife stereotactic radiosurgery
16203871|NCT01364246|Biological|human umbilical cord mesenchymal stem cells|Participants will be given hUC-MSCs transplantation.
16203872|NCT01364233|Device|MotifMESH|Polytetrafluoroethylene (cPTFE) macroporous mesh
16203873|NCT01364220|Drug|Rosuvastatin|Rosuvastatin 20mg tablet, once daily, for 14 days
16203874|NCT01364220|Other|Placebo tablet|Placebo tablet, once daily, for 14 days
16203875|NCT01364207|Other|Caffeinated Coffee|Participants will drink one 8 oz cup in the morning hours. Participants have 15 minutes to drink the coffee but may do so in less time.
16203876|NCT01364207|Other|Decaffeinated Coffee|Participants will drink one 8 oz cup in the morning hours. Participants have 15 minutes to drink the coffee but may do so in less time.
16203877|NCT01364194|Drug|0.25% Bupivacaine|Periarticular injection with 20 ml of 0.25% bupivacaine before wound closure.
16203878|NCT01364194|Drug|0.9% normal saline|Periarticular injection with 20 ml of 0.9% normal saline before wound closure.
16203879|NCT01364181|Drug|Udenafil|Udenafil 50mg qd po
16203880|NCT01364155|Drug|LIM-0705|
16203881|NCT01364155|Drug|Placebo capsules|
16203882|NCT01364142|Procedure|endobronchial blocker|After intubation of endotracheal tube, the Uniblocker® was inserted into the endotracheal tube and advanced step by step with inflation of the blocker balloon until the peak inspiratory pressure dropped abruptly.
16203883|NCT01364129|Procedure|Ophthalmic Telemedicine|Participants receiving the intervention have digital images of their retina captured with a non-mydriatic camera. The images are then sent to Devers Eye Institute for review and report generation.
16203884|NCT01364103|Other|volume expansion|fluid loading of 10 mL/kg colloid (voluven)
16203885|NCT01364090|Drug|Pegylated interferon alfa 2b|Pegylated interferon alfa 2b 1.5 mcg/kg/week to a maximum of 150 mcg/week administered subcutaneously once weekly directly observed.
16203886|NCT01364090|Drug|Ribavirin|Ribavirin - 800-1400 mg daily according to weight taken orally with food, self administered in split doses.
16203887|NCT01364077|Drug|Ivabradine|Ivabradine 5 mg BID titrated to 7.5 mg if tolerated
16203888|NCT01364077|Drug|Placebo|Matched placebo
16203889|NCT01364064|Drug|TMZ|Comparing conventional adjuvant Temozolomide with dose intensive Temozolomide
16203890|NCT01364051|Drug|Cediranib|Given PO
16203891|NCT01364051|Drug|Cediranib Maleate|Given PO
16203892|NCT01364051|Other|Laboratory Biomarker Analysis|Correlative studies
16203893|NCT01364051|Other|Pharmacological Study|Correlative studies
16203894|NCT01364051|Drug|Selumetinib|Given PO
16203895|NCT01364051|Drug|Selumetinib Sulfate|Given PO
16203896|NCT01364025|Procedure|uterosacral ligament suspension colpopexy bilateral|Uterosacral ligament suspension colpopexy bilateral
16203897|NCT01364012|Drug|Bevacizumab|Bevacizumab will be administered at 15 mg/kg IV on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
16203898|NCT01364012|Drug|Carboplatin|Carboplatin will be administered at area under the plasma concentration-time curve (AUC) 6.0 IV on Day 1 of each 3-week cycle, up to 6 cycles.
16203899|NCT01364012|Drug|Paclitaxel|Paclitaxel will be administered at 175 milligrams per square meter (mg/m^2) IV on Day 1 of each 3-week cycle, up to 6 cycles.
16203900|NCT01364012|Drug|Placebo|Bevacizumab matching placebo will be administered IV on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity.
16203901|NCT01363999|Drug|atorvastatin|single dose of atorvastatin on day 1
16203902|NCT01363999|Drug|dalcetrapib|single dose of dalcetrapib on day 1
16203903|NCT01363986|Drug|trastuzumab [Herceptin]|Initial loading dose of 4 mg/kg i.v. infusion, followed by weekly doses of 2 mg/kg for up to 18 weeks.
16203904|NCT01363973|Device|VITALSTIM transcutaneous electrical stimulation|
16203905|NCT01363947|Drug|DNIB0600A|Several dose levels will be evaluated for DNIB0600A administered via IV infusion on Day 1 of each 21-day cycle until disease progression.
16203906|NCT01363934|Drug|GC1113|"Each Group volunteers (n=10) will be administered GC1113 0.3ug/kg to 5ug/kg or Placebo (GC1113:placebo=8:2) once intravenously.
~Each Group volunteers (n=10) will be administered GC1113 1ug/kg to 8ug/kg or Placebo (GC1113:placebo=8:2) once subcutaneously."
16203907|NCT01363934|Drug|Darbepoetin alfa|Each Group volunteers (n=8) will be administered Darbepoetin alfa by IV or SC.
16203908|NCT01363921|Device|HCO 1100|Dialysis treatment with HCO1100
16203909|NCT01363908|Drug|SPD602|
16203910|NCT01363895|Procedure|Percutaneous closure of LAA|Percutaneous closure of LAA
16203911|NCT01363895|Procedure|Catheter ablation of AF|Catheter ablation of AF
16203912|NCT01363882|Other|Sleep study-guided adjustment of NIV|Sleep studies will be performed at baseline, within 2 weeks to initially titrate NIV, and at 1, 3 and 6 months to assess NIV performance and adjust it as necessary based on oxygenation and ventilation parameters.
16203913|NCT01363882|Other|Standard initiation of NIV|NIV will be initiated and managed as per current standard of practice. Sleep studies will be performed at baseline, 2 weeks, 1, 3 and 6 months to gather data but will not influence NIV management. NIV will be adjusted by a respiratory therapist or the subject's primary physician per waking symptoms.
16203914|NCT01363869|Dietary Supplement|green tea extracts 2 gm/day|"Green tea extracts capsule (1 gm per capsule), taken after meal, twice daily for 14 days.
~Total dosage is 2 grams per day."
16203920|NCT01363830|Behavioral|Two-Week Post-Operative Restriction|Surgeon recommends the patient restrict bending, lifting, and twisting for two-weeks following discectomy.
16203921|NCT01363830|Behavioral|Six-Week Post-Operative Restriction|Surgeon recommends patient restrict bending, lifting, and twisting for six-weeks following discectomy.
16203922|NCT01363817|Drug|BMS-906024|
16203923|NCT01363817|Drug|Dexamethasone|
16203924|NCT01363804|Drug|Tivozanib|Tivozanib is a novel and potent pan-vascular endothelial growth factor (VEGF) receptor (VEGFR) tyrosine kinase inhibitor with potent activity against all 3 VEGFRs (VEGFR-1, -2, and -3). In nonclinical models and studies performed in humans, tivozanib has shown strong antiangiogenesis and antitumor activity.
16203925|NCT01363791|Other|Dietary fructose|Oral dietary fructose in free (unbound) form in isocaloric exchange for other non-fructose carbohydrate sources (isocaloric trials) or added to a control diet as a source of excess energy (hypercaloric trials).
16203926|NCT01363778|Drug|tivozanib|Tivozanib is a novel and potent pan-vascular endothelial growth factor (VEGF) receptor (VEGFR) tyrosine kinase inhibitor with potent activity against all 3 VEGFRs (VEGFR-1, -2, and -3). In nonclinical models and studies performed in humans, tivozanib has shown strong antiangiogenesis and antitumor activity.
16203927|NCT01363765|Other|Xpert MTB/Rif|Automatized RT-PCR for the detection of Mycobacterium tuberculosis, the agent of TB, in sputum samples
16203928|NCT01363765|Other|Smear microscopy|Sputum smears arriving in the laboratory during the observation period will be submitted to the classic routine smear staining. This would be the non-intervention (control) arm.
16203929|NCT01363752|Drug|Advagraf|oral
16203930|NCT01363752|Drug|Mycophenolate Mofetil|oral
16203931|NCT01363752|Drug|Sirolimus|oral
16203932|NCT01363752|Drug|Corticosteroids|i.v. and oral
16203933|NCT01363713|Drug|DE-114 ophthalmic solution|
16203934|NCT01363700|Drug|DE-114 ophthalmic solution|
16203935|NCT01363700|Drug|Placebo ophthalmic solution|
16203936|NCT01363700|Drug|Olopatadine Hydrochloride 0.1% Ophthalmic Solution|
16203937|NCT01363687|Device|remote ischemic postconditioning|Remote ischemic postconditioning consists of three 5-min cycles of upper limb ischemia, which was induced by an automated cuff-inflator placed on the upper limb free of arteriovenous fistula and inflated to 250 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated.
16203938|NCT01363674|Device|Easypod™|Saizen (Somatotropin) as per Summary of Product Characteristics administered by Easypod™
16203939|NCT01363661|Drug|Coruno|Molsidomine 16 mg tablet, per os, once a day
16203940|NCT01363661|Drug|Placebo|Placebo (16 mg tablet, per os; once-daily)
16203941|NCT01363648|Drug|choline alfoscerate|Participants were randomly assigned to twice-daily doses of 400mg choline alphoscerate (alpha-glyceryl phosphoryl choline, Gliatilin®)
16203942|NCT01363648|Drug|placebo (for choline alphoscerate)|Pill manufactured to mimic choline alfoscerate 400mg tablet
16203943|NCT01363609|Drug|Liraglutide treatment 12 weeks|liraglutide will be started with a titration period of 2 weeks: week 1 0.6mg once daily, week 2 1.2mg once daily. If well tolerated, treatment will be continued for 10 more weeks in dosage of 1.8mg once daily
16203944|NCT01363609|Drug|insulin glargine treatment|Insulin glargine treatment consist a treatment period of 12 weeks. Treatment will start with a dosage of 10 IU once daily. Patient will self-titrate the insulin glargine dosage based on self-monitored fasting blood glucose (FBG) concentrations for the previous 3 days using the following guideline: If FBG levels are above 5.6 mmol/L (100-153 mg/dL) on 3 consecutive mornings, the daily dose is to be increased by 2 IU/day. If hypoglycemia documented by glucose concentration < 3.3 mmol/L (60 mg/dL) or requiring assistance occurs without an easily identifiable reason (skipped meal, excessive physical activity), the daily dose is to be downregulated, with -2 IU/day
16203945|NCT01363609|Drug|GLP-1 receptor antagonist|Exendin 9-39 will be infused intravenously at doses of 600 pM/kg • min. This will only be during one of the visit for the healthy lean controls and the T2DM group, and during two visits in the group with obesity planned for gastric bypass surgery
16203946|NCT01363596|Other|Creighton Model System in conjunction with Natural Procreative Technology (NPT)|Patients will learn the Creighton Model System to chart their fertility biomarkers, and this information will then be used by their physician in conjunction with Natural Procreative Technology (NPT) to evaluated and treat infertility or history of spontaneous abortion.
16203947|NCT01363583|Drug|epoprostenol versus normal saline|0.5 ng/kilogram/minute during 4 days
16203948|NCT01363583|Drug|normal saline|0.5-1.5 ml/hour during 4 days
16203949|NCT01363570|Drug|Ranibizumab|Intra-vitreal injections of 0.5mg/0.05 mL dosage, injected at months 0, 1, and 2. For those requiring additional injections, patients will receive monthly treatment up to a maximum of 6 months total.
16203950|NCT01363557|Other|whole brain radiotherapy|External beam RT using a total dose of 30 Gy with ten daily fractions of 3.0 Gy given 5 days per week over 2 weeks + Gefitinib 250 mg/day
16203951|NCT01363557|Drug|Gefitinib (IRESSA)|250 mg/day
16203952|NCT01363544|Other|Neurofeedback|30 sessions of theta/beta neurofeedback within 10 weeks.
16203953|NCT01363544|Behavioral|Exercise|30 sessions of individual sports training during 10 weeks.
16203954|NCT01363544|Drug|methylphenidate|The medication treatment is based on the MTA study and includes methylphenidate dosages of 5, 10, 15 (only for children with a weight below 25 kg) and 20 mg (only for children with a weight above 25 kg. The optimum dose will be determined by a double-blind placebo-controlled trial.
16203955|NCT01363531|Other|Antibiotic prescription strategies|The patients enrolled will be randomized between four treatment strategies or arms. Patients randomized to delayed treatment arms or direct treatment, doctors can choose the antibiotic that they consider appropriate depending on such local resistance or practice.
16203956|NCT01363505|Device|BARD® Intra-abdominal Pressure monitor|monitor linked to foley catheter that is able to measure pressure inside bladder
16203957|NCT01363492|Biological|Replagal (agalsidase alfa)|0.2 mg/kg administered over 40 minutes every other week (EOW)
16203958|NCT01363479|Drug|Oral palonosetron|
16203959|NCT01363479|Drug|I.V. palonosetron|
16203960|NCT01363479|Drug|Dexamethasone|
16203961|NCT01363466|Procedure|hysterectomy|
16203962|NCT01363440|Drug|Intravitreal Aflibercept Injection (IAI; EYLEA®; BAY86-5321)|
16203963|NCT01363440|Procedure|Macular Laser Photocoagulation|Laser therapy
16203964|NCT01363414|Drug|0.18% sodium hyaluronate|one drop of preservative-free, hypotonic 0.18% sodium hyaluronate in one eye
16203965|NCT01363414|Drug|0.9% sodium chloride solution|one drop of sterile 0.9% sodium chloride solution in the other eye
16203966|NCT01363401|Biological|HYNR-CS inj|Intrathecal injection with 1ml/10kg of body weight at an interval of 26 days.
16203967|NCT01363401|Other|Control group|No treatment of HYNR-CS inj
16203968|NCT01363388|Drug|Placebo|BID for 84 days
16203969|NCT01363388|Drug|CCX168|BID for 84 days
16203970|NCT01363375|Procedure|Foot orthosis, footwear|flat insole, total contact insole , carbon fiber plate; general shoe and rocker sole shoe
16203971|NCT01363375|Procedure|Foot orthosis, Footwear|flat insole, total contact insole, carbon fiber plate; general shoe and rocker sole shoe
16203972|NCT01363375|Procedure|Foot orthosis, footwear|flat insole, total contact insole, carbon fiber plate; general shoe and rocker sole shoe
16203973|NCT01363362|Procedure|Selective Laser Trabeculoplasty|360° selective laser trabeculoplasty, 100 non-overlapping spots, energy 0,5-1,2 mJ
16203974|NCT01363349|Drug|CYP-1020|CYP-1020 (formerly known as BL-1020) is an orally available new chemical entity.
16203975|NCT01363349|Drug|Risperidone|
16203976|NCT01363336|Drug|Nifedipine (Adalat CR, BAYA1040)|patients who are administrated with Adalat CR for hypertension
16203977|NCT01363323|Drug|Methylnaltrexone (MNTX)|Dose 1
16203978|NCT01363323|Drug|Methylnaltrexone (MNTX)|Dose 2
16203979|NCT01363323|Drug|Methylnaltrexone (MNTX)|Dose 3
16203980|NCT01363323|Drug|Placebo|
16203981|NCT01363323|Drug|Moxifloxacin|
16203982|NCT01363310|Drug|Quetiapine XR|Dosage form: tablets Day 1-2: 50 mg Day 3-7: 150 mg Day 8-57: either 150 or 300 mg/day (flexible)
16203983|NCT01363310|Drug|Escitalopram|Dosage form: capsules Day 1-7: 10 mg Day 8-57: 10 or 20 mg/day (flexible)
16203984|NCT01363297|Drug|Inotuzumab Ozogamicin|"Part 1: Administered intravenously as 2 - 3 weekly doses over a 28-day cycle for a maximum of 6 cycles. Total dose per cycle 0.8 mg/m^2 to 2.0 mg/m^2.
~Part 2 Expansion and Part 3 Phase 2: Administered intravenously as 3 weekly doses over a 28-day cycle for a maximum of 6 cycles. Total initial dose per cycle 1.8 mg/m^2."
16203985|NCT01363284|Drug|Duloxetine|First week of placebo. then, initial dose of 30 mg/d will be given for one week, in order to minimize possible side effects and drop outs, and then a fixed dose of 60 mg/d will be given for additional 4 weeks
16203986|NCT01363271|Drug|Linezolid|IV and oral forms of linezolid are identified through a pre-specified list of National Drug Codes (NDCs).
16203987|NCT01363271|Drug|Vancomycin|IV form of vancomycin is identified through a pre-specified list of National Drug Codes (NDCs).
16203988|NCT01363271|Drug|Linezolid|IV and oral forms of linezolid are identified through a pre-specified list of National Drug Codes (NDCs).
16203989|NCT01363271|Drug|Vancomycin|IV form of vancomycin is identified through a pre-specified list of National Drug Codes (NDCs).
16203990|NCT01363258|Behavioral|Care-resistant mouth care (MOUTh)|The intervention combines best mouth care practices with a constellation of behavioral techniques that reduce threat perception and thereby prevent or de-escalate care-resistant behavior.
16203991|NCT01363258|Procedure|Evidence-based mouth care|Mouth care tailored to the needs of older adults, including care of dentures.
16203992|NCT01363245|Behavioral|Telephone Counseling|Telephone counseling: 7 calls over 6 weeks
16203993|NCT01363245|Behavioral|Fax-to-quit|referral to state smoking cessation 'quitline' for counseling - 1 call over 2 weeks
16203994|NCT01363232|Drug|BKM120 + MEK162|
16203995|NCT01363206|Biological|Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF)|GM-CSF will be administered subcutaneously daily for 14 days in a dose of 125 µg/m2 beginning on D1 of each 21-day cycle for 8 cycles until month 6. Maintenance therapy will begin at month 6 and will consist 14 days of GM-CSF repeated every 3 months for up to 2 years or until disease progression, whichever occurs first.
16203996|NCT01363206|Biological|Ipilimumab|Patients will be treated with 4 courses of ipilimumab administered every 3 weeks intravenously in a dose of 10 mg/kg, with appropriate stopping/de-escalation rules. Maintenance therapy will begin at month 6 and will consist of ipilimumab in the same dose administered at the end of cycle 4 repeated every 3 months for up to 2 years or until disease progression, whichever occurs first.
16203997|NCT01363193|Drug|Lean Body Weight-based heparin dose|"For patients who meet the inclusion criteria including body mass index of 30 and greater (and do not have any exclusion criteria), will have intravenous weight-based heparin (unfractionated heparin) dose based on their Lean body weight.
~Lean Body Weight is based on the formula by Janmahasatian et al. 2005. Calculated by a computer program; Male = [9270 x weight (kg)] / [6680+216 x BMI] Female = [9270 x weight (kg)] / [8780+244 x BMI]"
16203998|NCT01363180|Behavioral|Trier Social Stress Test (TSST)|The TSST is a standardized psychological stress challenge where a participant performs a speech and mental math task in front of 3 unfamiliar individuals, in order to evoke an HPA axis stress response in a laboratory setting.
16203999|NCT01363180|Other|No stress condition|
16204000|NCT01363167|Dietary Supplement|400 IU Cholecalciferol- Vitamin D Daily|Infants who are defined as vitamin D deficient at birth will be randomized to receive either 400 IU vitamin D/day or placebo daily until term age is reached.
16204001|NCT01363154|Other|Mozart K448|Subjects will receive auditory stimulation by exposure to Mozart's Sonata for Two Pianos in D Major, K448.
16204002|NCT01363154|Other|Beethoven's Für Elise|Subjects will receive auditory stimulation by exposure to Beethoven's Für Elise.
16204003|NCT01363154|Other|No music exposure|Subject's will not receive an intervention and will therefore, not receive auditory stimulation and/or exposure to music.
16204004|NCT01363141|Other|Regular AGE Diet|Regular AGE Diet
16204005|NCT01363141|Other|Low AGE Diet|One year reduction in dietary AGE intake.
16204006|NCT01363128|Drug|Cyclophosphamide|Given IV
16204007|NCT01363128|Drug|Cytarabine|Given IV
16204008|NCT01363128|Drug|Dexamethasone|Given IV or PO
16204009|NCT01363128|Drug|Doxorubicin Hydrochloride|Given IV
16204010|NCT01363128|Other|Laboratory Biomarker Analysis|Correlative studies
16204011|NCT01363128|Drug|Methotrexate|Given IV
16204012|NCT01363128|Biological|Ofatumumab|Given IV
16204013|NCT01363128|Drug|Vincristine Sulfate|Given IV
16204126|NCT01362257|Drug|Treatment Period 2 - Oral dose of GSK573719|single dose of 1000µg
16204014|NCT01363115|Dietary Supplement|Orange Juice fortified with Calcium and Vitamin D|Three 240 mL glasses of orange juice fortified with 350 mg Ca and 100 IU of D per serving
16204015|NCT01363115|Dietary Supplement|Orange juice without Ca or VitD|Three 240 mL glasses of orange juice without Ca or VitD
16204016|NCT01363115|Behavioral|Nutritional Counseling|Individual and group nutritional counseling by a registered dietitian
16204017|NCT01363102|Procedure|SOMS|Apply a number to mobilization goal for patient
16204018|NCT01363089|Drug|Ketorolac tromethamine|30 mg of intranasal ketorolac tromethamine (one 100 µL spray into each nostril of a 15%, pH 7.2 solution)
16204019|NCT01363089|Drug|Oxymetazoline hydrochloride|Single intranasal dose of oxymetazoline hydrochloride (Afrazine®) (3 sprays of a 0.05% solution into each nostril) followed 30 minutes later by 30 mg of intranasal ketorolac tromethamine (one 100 µL spray into each nostril of a 15%, pH 7.2 solution)
16204020|NCT01363076|Drug|Ketorolac Tromethamine|Single IN dose of 15 mg ketorolac tromethamine for subjects weighing <50 kg.
16204021|NCT01363076|Drug|Ketorolac Tromethamine|Single IN dose of 30 mg ketorolac tromethamine for subjects weighing ≥50 kg.
16204022|NCT01363063|Drug|Ketorolac tromethamine|One dose of 15 mg ketorolac tromethamine with a lidocaine hydrochloride free formulation in one nostril and one dose of 15 mg ketorolac tromethamine containing 6% lidocaine hydrochloride in the other nostril
16204023|NCT01363063|Drug|Ketorolac tromethamine|One dose of 15 mg ketorolac tromethamine containing 0% lidocaine hydrochloride into one nostril and either placebo or a single intranasal dose of 15 mg Ketorolac tromethamine containing 0%, 4% or 6% lidocaine hydrochloride into the other nostril
16204024|NCT01363050|Drug|Ketorolac tromethamine|Subjects received intranasal ketorolac tromethamine (30 mg) three times daily (t.i.d.) for three days (seven doses in total). Doses were administered every eight hours.
16204025|NCT01363037|Drug|Dapivirine Vaginal Ring|dosage form: dapivirine vaginal ring dosage:25 mg frequency:continuous use duration:28 days
16204026|NCT01363037|Drug|Maraviroc Vaginal Ring|dosage form: maraviroc vaginal ring dosage:100 mg frequency:continuous use duration:28 days
16204027|NCT01363037|Other|Placebo Vaginal Ring|dosage form: placebo vaginal ring dosage:N/A frequency:continuous use duration:28 days
16204028|NCT01363037|Drug|Dapivirine-Maraviroc Vaginal Ring|dosage form: combination vaginal ring dosage:25 mg dapivirine + 100 mg maraviroc frequency:continuous use duration:28 days
16204029|NCT01363024|Drug|MFGR1877S|Intravenous escalating dose
16204030|NCT01363011|Drug|E/C/F/TDF|E/C/F/TDF (150/150/200/300 mg) STR administered orally once daily
16204031|NCT01363011|Drug|COBI|COBI 150 mg tablet administered with food orally once daily
16204032|NCT01363011|Drug|ATV|ATV 300 mg tablet administered orally once daily
16204033|NCT01363011|Drug|DRV|DRV 800 mg tablet administered orally once daily
16204034|NCT01363011|Drug|NRTI|Participants will receive 2 investigator-selected NRTIs, which may include abacavir (ABC), lamivudine (3TC)/zidovudine (ZDV), didanosine (DDI), emtricitabine (FTC), ABC/3TC, 3TC, tenofovir disoproxil fumarate (TDF), or FTC/TDF, administered according to prescribing information.
16204035|NCT01362998|Drug|Preservative free morphine|3mg given epidurally during the Cesarean section.
16204036|NCT01362998|Drug|Fentanyl|An infusion of epidural fentanyl started during the Cesarean section. It will be given on a patient controlled analgesia basis, with a basal rate of 60 micrograms, a demand dose of 16 micrograms, and a lockout of 15 mins.
16204037|NCT01362959|Drug|Transdermal nicotine patch|The test product is a transdermal nicotine patch. The dosage of the test product depends on the amount of cigarettes used by a specific patient (21 or more or less than 21) delivering 21 or 14 mg nicotine/24 hrs. During the study period of thirty (30) days a patch will be applicated daily.
16204038|NCT01362959|Other|Cutaneous patch, containing no active substances|During the study period of thirty (30) days, the control product will be applicated daily.
16204039|NCT01362946|Behavioral|Reward-Emphasized Treatment|Intensive behavioral treatment delivered in a summer camp setting, with reward components emphasized and punishment components de-emphasized
16204040|NCT01362946|Behavioral|Standard Treatment|Intensive behavioral treatment delivered in a summer camp setting, with rewards and punishment equally emphasized.
16204041|NCT01362933|Procedure|VTE treatment in cancer patient description|proportion of patients treated for evolutive VTE according to international recommendations
16204042|NCT01362907|Device|Delefilcon A contact lens|Investigational, silicone hydrogel, single vision, soft contact lens for daily disposable wear
16204043|NCT01362907|Device|Etafilcon A contact lens|Commercially marketed, HEMA-based, single vision, soft contact lens for daily disposable wear
16204044|NCT01362894|Device|nelfilcon A contact lens|Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear.
16204045|NCT01362894|Device|etafilcon A contact lens|Commercially marketed, etafilcon A, toric, soft contact lens for daily disposable wear.
16204046|NCT01362868|Device|SENSIMED Triggerfish®|Soft contact lens-based device for the continuous monitoring of IOP fluctuations
16204047|NCT01362829|Other|Determined by intended physician|We perform a prospective observational study. All the treatment for the patients are determined by intended physicians.
16204049|NCT01362790|Drug|Pentostatin|Regimen A: Cycle 1: 4 mg/m^2 on days 1, 5 and 9 of 30 day cycle Cycles 2-4: 4 mg/m^2 on day 1 of 21 day cycle Regimen B: Cycle 1: 4 mg/m^2 or 2 mg/m^2 on days 1, 5, 9, 13 and 17 of 38 day cycle Cycles 2-6: 4 mg/m^2 on days 1 and 5 of 25 day cycle
16204050|NCT01362790|Drug|Cyclophosphamide|Regimen A:Cycle 1: 200 mg/day on days 1-12 of 30 day cycle Cycles 2-4: 200 mg/day on days 1-4 of 21 day cycle Regimen B:Cycle 1: 200 mg/day on days 1-20 of 38 day cycle Cycles 2-4: 200 mg/day on days 1-8 of 25 day cycle
16204051|NCT01362790|Biological|SS1(dsFv)PE38 - lot 073I0809|Regimen A: Cycle 1: Cycle 1: 35mcg/kg days 10, 12 and 14 Cycles 2-4: Days 2, 4 and 6, for a maximum of six treatment cycles Regimen B: Cycle 1: 35mcg/kg days 18, 20 and 22 Cycles 2-4: (Days 6, 8 and 10), for a maximum of six treatment cycles
16204052|NCT01362790|Biological|SS1(dsFv)PE38 - lot FIL129J01|"Regimen A:
~Cycle 1: Cycle 1:35mcg/kg or 25 mcg/kg days 10, 12 and 14 Cycles 2-4: Days 2, 4 and 6, for a maximum of six treatment cycles"
16204087|NCT01362530|Drug|Aprepitant 125 mg|On the morning of Day 1: one 125 mg capsule PO 60 minutes prior to chemotherapy for participants 12 to 17 years of age
16204053|NCT01362777|Behavioral|In-patient rehabilitation|"Individualized exercise training (IET):
~Duration : 24 sessions during 4 weeks
~IET session (2h) contains:
~15' start warming up muscles
~30' muscle strengthening exercise for arms and abdominal muscles
~45' individualized cycle ergometer endurance training to the ventilatory threshold heart rate measured on the cardiopulmonary exercise test.
~15' stretching
~15' postural, movement and balance exercises IET session was controlled by a professional instructor using heart rate monitoring. Duration, intensity and attendance were recorded in a logbook.
~Educational activities (20h): the 8 themes are comparable to comparator arm. Dietary management: was performed by dietician to ensure that energy intakes are adjusted to energy expenditure. No restrictive diet was prescribe."
16204054|NCT01362777|Behavioral|Educational activities alone|"Educational activities alone contains 10 sessions lasting 1:00 with 8 themes :
~Physiological mechanisms of apneas/hypopneas
~Effects of apneas/hypopneas on health (vascular morbidity/mortality and sleepiness)
~Beneficials effects of CPAP and/or advanced mandibular orthosis
~Description of sleep stages and physiological roles of sleep
~Known effects of exercise on sleep and metabolism
~Importance of good nutritional status and sleep hygiene on quality of life
~How to apply theses lessons of rehabilitation in daily life"
16204055|NCT01362764|Drug|Abiraterone acetate suspension Formulation 1|Type=exact, unit=mg/mL, number=25, form=oral suspension, route=oral use, as a single dose of 10 mL
16204056|NCT01362764|Drug|Abiraterone acetate suspension Formulation 2|Type=exact, unit=mg/mL, number=25, form=oral suspension, route=oral use, as a single dose of 10 mL
16204057|NCT01362764|Drug|Abiraterone acetate tablets|Type=exact, unit=mg, number= 250, form=tablet, route=oral use, as a single dose
16204058|NCT01362751|Other|No intervention|This study is an observational cohort study > no interventions
16204059|NCT01362738|Procedure|RFCA of PV and extra-PV triggers|PVAI and isolation of extra PV triggers
16204060|NCT01362738|Procedure|LAA isolation along with the conventional ablation strategy|PVAI + isolation of extra PV triggers + LAA isolation
16204061|NCT01362725|Device|Spinal cord stimulation system|An implantable pulse generator (IPG) will deliver low-intensity electrical pulses which travel from the IPG through the leads to the electrodes positioned at the selected nerve fibers to provide the therapeutic stimulation.
16204062|NCT01362712|Radiation|[F18]CP-18 Injection|Normal volunteers dose will not exceed 20 mCi. For cancer subjects, the dose will be closer to 10 mCi.
16204063|NCT01362699|Drug|JNJ-31001074|Type=exact number, unit=mg, number=3, form=tablet, route=oral use. One tablet once daily for 7 days.
16204064|NCT01362699|Drug|Placebo|Form=tablet, route=oral administration. One tablet once daily for 7 days.
16204065|NCT01362686|Drug|Donepezil|The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care.
16204066|NCT01362686|Drug|Galantamine|The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care.
16204067|NCT01362686|Drug|Rivastigmine|The study is open-label and the memory care practice physicians will make determinations about initial drug dosage and any dosage changes and the timing of those changes. These physicians will also make the determination about whether to switch to a different anti-dementia drug, add memantine, or any other agent. We will, of course, monitor the frequency and content of such changes in the natural course of patient care.
16204068|NCT01362673|Drug|PF-04171327|Oral single 5 mg dose as one 5 mg tablet
16204069|NCT01362673|Drug|PF-04171327|Oral single 10 mg dose as one 10 mg tablet
16204070|NCT01362673|Drug|PF-04171327|Oral single 30 mg dose as three 10 mg tablets
16204071|NCT01362673|Drug|Placebo|Oral single dose as matching placebo
16204072|NCT01362673|Drug|PF-04171327|Oral multiple 20 mg doses as two 10 mg tablets for 12 days
16204073|NCT01362673|Drug|Placebo|Oral multiple doses as matching placebo for 12 days
16204074|NCT01362660|Other|Unintentional exposure in utero|This study will examine post-natal neurologic and cognitive development of infants who may have been exposed to tanezumab or comparator in-utero during the tanezumab clinical program (whether the exposure is through maternal or paternal participation in a tanezumab clinical study).
16204075|NCT01362647|Procedure|neuromuscular transmission monitoring|The acceleromyographic responses of the adductor pollicis muscle as percent of the train-of-four (TOF%) on stimulation of the ulnar nerve by means of TOF-Watch®, Organon Ireland Ltd., a division of MSD, Swords, Co., Dublin, Ireland.
16204076|NCT01362647|Procedure|Pulse oximetry measurement|Pulse oximetry will be measured continuously throughout the PACU admission, and SpO2 values will be recorded at 1-min intervals for the first 30 min.
16204077|NCT01362634|Behavioral|Trans-theoretical Process of Change Model-self|self-administered, computer-based intervention
16204078|NCT01362634|Behavioral|Trans-theoretical Process of Change Model - interviewer|interviewer-administered intervention
16204079|NCT01362608|Drug|Canakinumab, ACZ885|Canakinumab and placebo matching to triamcinolone acetonide
16204080|NCT01362608|Drug|Triamcinolone acetonide|Triamcinolone acetonide 40 mg and placebo matching to canakinumab
16204081|NCT01362595|Drug|leucine|"Dosage of leucine will be dependent on body surface area (BSA):
~leucine 700 mg/m2/dose by mouth three times a day"
16204082|NCT01362582|Drug|SMOF Kabiven|SMOFKabiven® will be given over night with a content of 1100 kcal in 986 ml.
16204083|NCT01362556|Drug|Sodium bicarbonate|"Administration of a calculated amount of sodium bicarbonate 8% [SB] after arterial blood gas measurement according to Base Excess [BE] and Body weight [kg].
~Formula: SB [ml] = -BE * kg * 0.1"
16204084|NCT01362556|Drug|Sodium Chloride|"Administration of a calculated amount of sodium chloride 0.9% [SC] after arterial blood gas measurement according to Base Excess [BE] and Body weight [kg].
~Formula: SC [ml] = -BE * kg * 0.1"
16204085|NCT01362543|Other|Cognitive behavioural therapy (stress management)|Following a manual
16204086|NCT01362543|Other|Cognitive Behavioural Therapy (cognitive restructuring)|Following a manual
16204127|NCT01362244|Drug|Mepolizumab|750 mg of mepolizumab by IV infusion
16204088|NCT01362530|Drug|Aprepitant 80 mg|On the morning of Days 2 and 3: one 80 mg capsule PO for participants 12 to 17 years of age
16204089|NCT01362530|Drug|Aprepitant powder for suspension (PFS)|On the morning of Day 1: 3.0 mg/kg (up to 125 mg) PO 60 minutes prior to chemotherapy for participants 6 months to <12 years of age. On the morning of Days 2 and 3: 2.0 mg/kg (up to 80 mg) PO 60 minutes prior to chemotherapy (if applicable) for participants 6 months to <12 years of age
16204090|NCT01362530|Drug|Ondansetron|Day 1: Administered according to product label for pediatric usage or local standard of care
16204091|NCT01362530|Drug|Placebo for Aprepitant 125 mg|On the morning of Day 1: one 125 mg capsule PO 60 minutes prior to chemotherapy for participants 12 to 17 years of age
16204092|NCT01362530|Drug|Placebo for Aprepitant 80 mg|On the morning of Days 2 and 3: one 80 mg capsule PO for participants 12 to 17 years of age
16204093|NCT01362530|Drug|Placebo for Aprepitant PFS|On the morning of Day 1: 3.0 mg/kg (up to 125 mg) PO 60 minutes prior to chemotherapy for participants 6 months to <12 years of age. On the morning of Days 2 and 3: 2.0 mg/kg (up to 80 mg) PO 60 minutes prior to chemotherapy (if applicable) for participants 6 months to <12 years of age
16204094|NCT01362530|Drug|Emetogenic chemotherapy|"Any moderately or highly emetic chemotherapeutic agent such as cyclophosphamide, doxorubicin, methotrexate, carboplatin, cisplatin, irinotecan, carmustine, ifosfamide, and streptozocin, or chemotherapeutics of a lower emetogenicity that were not previously tolerated. No chemotherapeutic agents were specified by the protocol, and many could potentially have been used."
16204095|NCT01362517|Biological|Quinvaxem|"A single dose (0.5 mL) of Quinvaxem contains:
~diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen
~One dose of Quinvaxem given at 2, 3 and 4 months of age"
16204096|NCT01362491|Drug|Ibuprofen Sodium|Single-dose of ibuprofen sodium tablets (equal to 400 mg ibuprofen)
16204097|NCT01362491|Drug|Standard Ibuprofen|Single-dose of standard ibuprofen tablets (400mg)
16204098|NCT01362491|Drug|Placebo|Single-dose of placebo
16204099|NCT01362465|Procedure|Cardiac Resynchronization Therapy|Implanting device to measure delays between paced chambers in heart failure patients.
16204100|NCT01362452|Genetic|T-Cell Infusion|Infusion of CD19-specific T cells derived from cord blood (CB) 42 days following stem cell transplantation.
16204101|NCT01362452|Procedure|Cord Blood Infusion|Cord blood infusion on Day 0.
16204102|NCT01362439|Drug|Paliperidone ER|Participants will be administered paliperidone extended release (ER) tablets orally (taken by mouth; to be swallowed) once daily in the dose range of 3 to 12 milligram (mg) for 13 weeks. Dose will be increased or decreased as per Investigator's discretion.
16204103|NCT01362426|Drug|paliperidone palmitate|Dosage and administration will be according to the paliperidone palmitate approved Australian Product Information.
16204104|NCT01362400|Drug|IPI 504 plus Docetaxel|"450 mg/m2 (starting dose) IPI-504 or placebo IV (in the vein) day 1, 8 & 15 during each 21 day cycle
~75 mg/m2 in US and EU, 60 mg/m2 in South Korea and Taiwan Docetaxel (Taxotere®) will be administered by IV infusion every 3 weeks (Day 1 of each 21-day cycle)"
16204105|NCT01362400|Drug|Placebo plus Docetaxel|"450 mg/m2 (starting dose) IPI-504 or placebo IV (in the vein) day 1, 8 & 15 during each 21 day cycle
~75 mg/m2 in US and EU, 60 mg/m2 in South Korea and Taiwan Docetaxel (Taxotere®) will be administered by IV infusion every 3 weeks (Day 1 of each 21-day cycle)"
16204106|NCT01362387|Other|Alternative follow-up protocol|Women (n=1000) will be allocated by chance to one of two groups: alternative follow-up using a standard text message, online or telephone questionnaire and a low sensitivity urine pregnancy test, or standard follow-up which consists of an in person visit with an ultrasound or a telephone call and high sensitivity pregnancy test.
16204107|NCT01362374|Drug|5-FU|5-FU at a dose level of 400 mg/m^2 as intravenous (IV) injection followed by a dose of 2400 mg/m^2 as IV infusion over 46 hrs will be administered on Day 1 of each 14-day cycle until disease progression or unacceptable toxicity.
16204108|NCT01362374|Drug|Docetaxel|Docetaxel will be administered at dose level of 75 mg/m^2 as IV infusion over 1 hr on Day 1 of each 21-day cycle until disease progression or unacceptable toxicity.
16204109|NCT01362374|Drug|Enzalutamide|Enzalutamide will be administered orally at a dose level of 160 mg once daily continuously as per schedule defined in respective arm until disease progression or unacceptable toxicity.
16204110|NCT01362374|Drug|Ipatasertib|Ipatasertib will be administered orally (in escalating doses during Stage 1 followed by at a dose decided during Stage 1) as per schedule defined in the respective arms.
16204111|NCT01362374|Drug|Leucovorin|Leucovorin at a dose level of 400 mg/m^2 as IV infusion over 2 hrs will be administered on Day 1 of each 14-day cycle until disease progression or unacceptable toxicity.
16204112|NCT01362374|Drug|Oxaliplatin|Oxaliplatin at a dose level of 85 mg/m^2 as IV infusion over 2 hours will be administered on Day 1 of each 14-day cycle until disease progression or unacceptable toxicity.
16204113|NCT01362374|Drug|Paclitaxel|Paclitaxel at a dose of 90 mg/m^2 as IV infusion over 1 hr will be administered on Days 1, 8, and 15 of each 28-day cycle until disease progression or unacceptable toxicity.
16204114|NCT01362361|Drug|mFOLFOX6 + BIBF 1120|mFOLFOX6 + BIBF1120 (2x200 mg/d d1-d14) (repeated every 14 days)
16204115|NCT01362361|Drug|mFOLFOX6+placebo|mFOLFOX6 + placebo (2x200 mg/d d1-d14) (repeated every 14 days)
16204116|NCT01362348|Drug|pazopanib eye drops|10 mg/mL (1 drop) four times daily
16204117|NCT01362322|Biological|Boostrix TM (new syringe presentation)|Single dose, intramuscular administration in a new syringe presentation
16204118|NCT01362322|Biological|Boostrix TM (previous syringe presentation)|Single dose, intramuscular administration in previous syringe presentation
16204119|NCT01362309|Drug|d-cycloserine.|50 mg administered on two occasions.
16204120|NCT01362296|Drug|GSK1120212|Oral once daily
16204121|NCT01362296|Drug|docetaxel|IV once every 3 weeks
16204122|NCT01362283|Other|Blood Sampling|Blood sampling for Fasting Plasma Glucose, Hemoglobin A1C, Cholesterols, Blood Urea Nitrogen, Creatinine
16204123|NCT01362270|Device|Verum Acupuncture|DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days
16204124|NCT01362270|Device|Sham Acupuncture|DOSAGE: 25 acupoints per session FREQUENCY: 2 sessions per day DURATION: 5 days
16204125|NCT01362257|Drug|Treatment Period 1 - IV dose of GSK573719|single dose of 65µg
16204128|NCT01362244|Drug|Placebo|Placebo by IV infusion
16204129|NCT01362244|Drug|Run In Medication|subjects will undergo a run-in period of 10 - 14 days on a low dose of Intranasal Steroids (INS).
16204130|NCT01362231|Drug|GS-6624|Patients will be treated with GS-6624 (125 or 200 mg) administered IV over 1 hour on specific days during the treatment period.
16204131|NCT01362218|Drug|Cardiovascular fixed dose combination pill (acetylsalicylic acid, simvastatin and ramipril)|A once daily oral dose of the cardiovascular fixed dose combination pill ( acetylsalicylic acid, simvastatin, ramipril) for 8 weeks.
16204132|NCT01362218|Drug|Simvastatin, ramipril, acetylsalicylic acid|A once daily oral dose of simvastatin, ramipril, acetylsalicylic acid for 8 weeks
16204133|NCT01362205|Drug|Dexmedetomidine|
16204134|NCT01362205|Drug|Placebos|Inactive placebo (normal saline)
16204135|NCT01362192|Device|532 nm KTP Excel V Laser, manufactured by Cutera, Inc.|"The 532 nm KTP Excel V laser treatment parameters to be used in this study are as follows:
~Spot Size: 5 mm
~Fluence: 13-15 J/cm2
~Pulse Duration: 40 ms
~Epidermal contact-cooling: 5° Celsius"
16204136|NCT01362153|Drug|Golimumab|SC injection of 100 mg every 4 weeks through Week 20
16204137|NCT01362153|Drug|Golimumab|IV infusions of 2 mg/kg golimumab on Days 1 and 85.
16204138|NCT01362140|Drug|Darbepoetin alfa|Administered by subcutaneous injection every 3 weeks
16204139|NCT01362140|Drug|Placebo|Administered by subcutaneous injection every 3 weeks
16204140|NCT01362127|Drug|Chemotherapy|Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values.
16204141|NCT01362127|Radiation|Radiochemotherapy|Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values.
16204142|NCT01362114|Drug|SIHOGAYONGGOLMORYU TANG EXTRACT GRAN|three times a day, AC 30 min., 4 capsules taken each time (4capsules=2.5g), 8 weeks
16204143|NCT01362114|Other|Placebo|three times a day, AC 30 min., 4 capsules taken each time (4capsules=2.5g), 8 weeks.
16204144|NCT01362101|Behavioral|Mindfulness behavioral intervention (MT),cognitive behavioral intervention (CBT)|"60 smokers will enter a separate 4 wk group sessions trial that evaluates efficacy of MT in comparison to CBT for smoking cessation. During the parent study, participants will receive bi-weekly sessions of either MT or CBT, for 4 weeks and to set a quit date at the end of the 2nd week. In this context, we will examine participants at two points:
~Week 0-1 of MT/CBT: development of smoking scripts based participant's descriptions of situations that trigger tobacco craving.
~Then participants will undergo pre-treatment (week 0-1) and post treatment (week 4) psychophysiological activation to smoking-related cues using the script driven imagery technique, in vivo cues, salivary cortisol testing and to complete a computerized SST protocol."
16204145|NCT01362075|Procedure|Local infiltration analgesia|150 ml ropivacaine, of which 100 ml is with adrenalin
16204146|NCT01362075|Procedure|Interscalene catheter|7 ml ropivacaine interscalene block via catheter, subsequently given 5 ml/h and possibility of 5 ml bolus for the first 48 hours.
16204147|NCT01362062|Drug|Tocilizumab|
16204148|NCT01362049|Other|Physical Therapy rehabilitation: Stabilization exercises.|The stabilization exercise protocol consists of exercises focused on improving the ability of trunk muscles to stabilize the spine, beginning with training to isolate the deeper abdominal muscles and then incorporation of these isolated contractions into other exercises. The exercise protocol progresses to include trunk flexion and extension strengthening exercises as well as abdominal bracing exercises in supine and quadruped positions, and finally to exercises in more functional positions.
16204149|NCT01362049|Other|Physical Therapy rehabilitation. Movement System Impairment (MSI) classification based exercise|The MSI-classification based approach focuses on education and instruction for modifying movement strategies during functional activities, and on exercises that are specific to the classification category. First there is an analysis of and instruction in modifying a subject's direction-specific alignment and movement strategies during symptomatic functional activities. Second, there is education about the principles of tissue injury and healing, and how cumulative tissue stress contributes to microtrauma and LBP. Unique to the education process is the emphasis on how using one's particular movement strategies during functional activities may accelerate tissue stress accumulation because the strategies are used repetitively. Thirdly, there is exercise prescription that includes practice in performing modified versions of the direction-specific impairment tests from the physical exam, with an emphasis on impairments that can be modified to eliminate LBP symptoms.
16204150|NCT01362036|Drug|TXA127|Cohorts in this study will receive 300, 600, or 900 ug/kg daily by subcutaneous injection
16204151|NCT01362023|Behavioral|lifestyle counseling|"In 3 academic years, the intervention program consisted of three components:
~Classroom practice by HPA to highlight healthy lifestyle habits
~Teaching practice by HPA using books designed to include the nutritional objectives
~Parental activities included with their children
~In each of 12 activities (1 h/activity), the classroom practice consisted of three components:
~Experimental development of activities regarding each healthy lifestyle habit
~Assessment of activity performed in classroom
~An activity developed for use at home"
16204152|NCT01362010|Drug|Topical Minocycline Foam FXFM244|Topically applied once a day.
16204153|NCT01361997|Biological|chlorhexidine in isopropyl alcohol|When a hemoculture is ordered, the laboratory technician will prepare the necessary materials for venipuncture. Previously the technician must take randomly a sealed envelope, where will be writing the antiseptic to be used for antisepsis. The technician will select a site for venipuncture, preferably in the forearm, and will do the antisepsis in the site selected, letting act the substance for 45 seconds. After this procedure, the venipuncture shall be done. The sample will be cultured for 120 hours at 35 +/- 2°C.
16204154|NCT01361997|Biological|Isopropyl alcohol|When a hemoculture is ordered, the laboratory technician will prepare the necessary materials for venipuncture. Previously the technician must take randomly a sealed envelope, where will be writing the antiseptic to be used for antisepsis. The technician will select a site for venipuncture, preferably in the forearm, and will do the antisepsis in the site selected, letting act the substance for 45 seconds. After this procedure, the venipuncture shall be done. The sample will be cultured for 120 hours at 35 +/- 2°C.
16204155|NCT01361984|Drug|Nebulized arformoterol|Arformoterol tartrate 15 µg/2ml (Brovana) nebulized via PARI-LC Plus® nebulizer with a mouthpiece, connected to a PRONEB® Ultra compressor. The nebulization time is ~9 minutes
16204156|NCT01361984|Drug|Salmeterol|Salmeterol 50 mcg (Serevent) via Diskus dry powder inhaler
16204157|NCT01361971|Procedure|Hyperbaric Oxygen Treatment|Participants will undergo 4 treatments of hyperbaric oxygen. Each treatment consists of 90 minutes compression at 2 atmospheres of pressure, with 30 minutes decompression back to 1 atmosphere, during this time, patients will be treated with 100% Oxygen delivered via a hood system.
16204158|NCT01361958|Drug|NOMAC|
16204159|NCT01361945|Drug|AUY922|AUY 922 is given intravenously weekly; letrozole and lapatinib are given orally
16204160|NCT01361932|Other|Video of ED discharge instructions for patient's ED discharge diagnosis|Link provided for a website of 38 ED discharge instruction videos, based on ED discharge diagnosis; patients in study group encouraged to view it upon returning home. Three key questions asked by RA 1 to 5 days later, via phone call, and answers scored.
16204161|NCT01361919|Procedure|Feedback During CPR Training and Testing|"Students in this group will receive training in BLS skills according to the 2005 AHA/ILCOR guidelines, using the ZOLL R Series™ defibrillator with an attached accelerometer pad that will be placed on the sternum of the manikin and visible to the user. Participants will be taught to use and follow the audio and visual feedback provided by the accelerometer and defibrillator to optimize their CPR performance (depth, rate, and minimal hands-off time). After the simulated cardiac arrest scenario, a data card containing the raw data collected from the accelerometer and defibrillator will be downloaded onto a laptop and used as a demonstration and training tool."
16204162|NCT01361919|Procedure|No Feedback Group|"A standard no feedback defibrillator (ZOLL M series) will be used for teaching, immediate testing and 12 week (retention) testing. In order to collect CPR performance data, a simulation manikin with an attached accelerometer pad hidden from view within its chest will be used. Subjects will be told to perform compressions on top of the manikin's chest. During the test, subjects will be informed that data on their performance will be recorded but they will not be told how this will occur."
16204163|NCT01361919|Procedure|Feedback during CPR Training Not Testing|Students in this group will be tested using a five minute basic vfib arrest scenario and an R-series defibrillator and told to perform compressions on top of the accelerometer pad. The hexagonal icon will be visible but no prompting on its usage will be delivered during testing.
16204164|NCT01361906|Behavioral|Sensomotoric training|"The intervention will be given once a week (2h per occasion) for twelve weeks.
~Each occasion is planned to have the following structure:
~10 min initial conversation about how participants are feeling today and how it felt after the last time.
~70 min guided sensory motor learning. 10 min final talks, reflections on how it felt today."
16204165|NCT01361893|Other|Lifestyle Counseling|We will utilize a combination of quantitative and qualitative techniques to ascertain factors, attitudes, and beliefs of African American parents of infants less than 6 months old.
16204166|NCT01361880|Behavioral|Reduce Infant Mortality|The study's long term goal is to disseminate a new easily implemented and reproducible intervention that based on our previous research is culturally competent and provides a rationale for changing infant sleep position and sleep environment. This intervention if successful will quickly be disseminated and will be an important change to the system of newborn care; the resultant change in parental behavior would ultimately result in a reduction in sleep-related infant mortality rates thereby promoting healthy development.After written consent has been obtained, a brief survey about knowledge of and attitudes toward safe sleep position recommendations, current intent with regards to safe sleep recommendations, and demographics will be completed. Contact information will be obtained from participants to facilitate study follow-up at two weeks of infants birth 2-3 months and 5-6 months.
16204167|NCT01361867|Device|Robot-induced perturbations|A robotic system is used to generate mechanical perturbations and study how subjects generate motor adaptations in response to the mechanical perturbations.
16204168|NCT01361854|Device|polysomnography|home-based polysomnography with hook-up performed ar at home or in the hospital
16204169|NCT01361841|Drug|Latanoprost, bimatoprost, travoprost|topic drops, once a day at bedtime, for years
16204170|NCT01361841|Drug|travoprost, latanoprost and bimatoprost|one drop once a day for life
16204171|NCT01361828|Procedure|Electrophysiology|Visual Evoked Potential and Elctroretinogram
16204172|NCT01361815|Device|H-Coil Deep TMS in combination with SSRIs|The study group will receive DTMS treatment three times a week for four weeks in combination with SSRI medications.
16204173|NCT01361802|Drug|Ambroxol Spray|low dose Ambroxol Spray
16204174|NCT01361802|Drug|Ambroxol Spray|medium dose Ambroxol Spray
16204175|NCT01361802|Drug|Ambroxol Spray|high dose Ambroxol Spray
16204176|NCT01361802|Drug|Placebo Spray|Placebo Spray
16204177|NCT01361789|Drug|parecoxib, valdecoxib, etoricoxib|"40 mg parecoxib (Dynastat, Pfizer®) one hour before surgery and 40 mg valdecoxib (prodrug of parecoxib, Bextra, Pfizer®)were given 8 hour after surgery.
~After retraction of parecoxib from the market:
~Etoricoxib (Arcoxia, MSD) 120 mg given one hour before surgery"
16204178|NCT01361789|Drug|Dexamethasone|8 mg IV
16204179|NCT01361789|Drug|parecoxib, valdecoxib, parecoxib and dexamethasone|combination of both drugs
16204180|NCT01361776|Biological|FSME-immune|0.5 ml im as scheduled in the 4 arms
16204181|NCT01361763|Drug|Dabigatran|110 mg twice daily
16204182|NCT01361763|Drug|Antiplatelets|100mg once a day
16204183|NCT01361750|Procedure|gastric tube|the stomach will be cut into a narrowed tube-shape conduit
16204184|NCT01361724|Behavioral|Physical therapy|Physical therapy program for people with PD--one on one with a PT
16204185|NCT01361724|Behavioral|Group Exercise Class|The participant will be in an exercise class for 3 days a week for 4 weeks.
16204186|NCT01361724|Behavioral|Home Program|The participant will meet one time with a physical therapist and will be given a home program--which is standard of care--to follow for 4 weeks.
16204187|NCT01361711|Biological|alemtuzumab|Given SC
16204188|NCT01361711|Biological|ofatumumab|Given IV
16204189|NCT01361711|Procedure|biopsy|Correlative studies
16204190|NCT01361698|Behavioral|Illness Management and Recovery (IMR)|In this Danish trial IMR will be implemented in group format with 10 patients assigned to each group and two IMR facilitators, and the IMR program will require nine months of weekly sessions to complete.
16204191|NCT01361659|Procedure|shockwave treatment|9 treatments in 3 months
16204192|NCT01361646|Drug|LC350189|Single Ascending Dose: 10, 25, 50, 100, 200, 400, 600mg Multifle Ascending Dose: 100, 200, 400, 600, 800mg
16204193|NCT01361633|Drug|d-cycloserine|single oral administration of 250 mg d-cycloserine
16204194|NCT01361633|Drug|Sugar Pill|Single oral administration 250 mg Sugar Pill
16204195|NCT01361620|Drug|aspirin|aspirin 81mg, 7-10 days
16204196|NCT01361607|Drug|Nabiximols|
16204197|NCT01361607|Drug|Placebo (GA-0034)|
16204198|NCT01361594|Other|Regular insulin (intensive treatment)|Titration of the IV insulin rate for glucose goal 100-140 mg/dL
16204199|NCT01361594|Other|Regular Insulin (conventional treatment)|Titration of the IV insulin rate for glucose goal 141-180 mg/dl
16204200|NCT01361568|Drug|CR845|Single i.v. dose (0.04 mg/kg) administered preoperatively
16204201|NCT01361568|Drug|Placebo|Single i.v. dose administered preoperatively
16204202|NCT01361568|Drug|CR845|Single i.v. dose (0.04 mg/kg) administered postoperatively for pain
16204203|NCT01361568|Drug|Placebo|Single i.v. dose administered postoperatively for pain
16204204|NCT01361555|Drug|Placebo matching with BMS-820836|Tablet, Oral, 0.0 mg, Once daily, 54 weeks
16204205|NCT01361555|Drug|BMS-820836|Tablet, Oral, 0.5 mg, Once daily, 54 weeks
16204206|NCT01361555|Drug|BMS-820836|Tablet, Oral, 1.0 mg, Once daily, 54 weeks
16204207|NCT01361555|Drug|BMS-820836|Tablet, Oral, 2.0 mg, Once daily, 54 weeks
16204208|NCT01361542|Drug|anti TNF alpha agent|Anti TNF alpha therapy included either INFLIXIMAB or ETANERCEPY Infliximab at 3-5 mg/kg at recommended protocols for the duration of the study Etanercept at 50mg weekly for the duration of the study
16204209|NCT01361542|Drug|Anti TNF alpha therapy|Infliximab 3-5 mg/kg as per recommended protocol or Etanercept 50mg/week for 1 year
16204210|NCT01361529|Drug|FLP,dose escalation,MTD|dosage from 93mg/m2 to 331mg/m2, 7 days' continuous dosing, 21 days for one cycle
16204211|NCT01361516|Other|Anaesthesia and Lithotripsy|The efficacy of stone fragmentation during lithotripsy procedure is compared under two types of anaesthesia
16204212|NCT01361464|Drug|Tipifarnib|Given PO
16204213|NCT01361464|Other|Laboratory Biomarker Analysis|Correlative studies
16204214|NCT01361438|Other|Total therapy approach|Total therapy approach
16204215|NCT01361425|Drug|methildopa|methildopa, 1,5g/day (500mg 8/8 hours, orally)
16204216|NCT01361425|Drug|placebo|placebo 500mg 8/8h, orally
16204217|NCT01361412|Biological|ToleroMune Ragweed|Intradermal administration 1x8 administrations, 2 weeks apart
16204218|NCT01361412|Biological|Placebo|Intradermal injection 1x8 administrations, 2 weeks apart
16204219|NCT01361399|Drug|Acetylsalicylic acid (Aspirin, BAYE4465) & Lidocain|Single oral application of a fixed combination of Aspirin and Lidocain (as one lozenge)
16204220|NCT01361399|Drug|Acetylsalicylic Acid (Aspirin, BAYE4465)|Single oral application of Aspirin (as lozenge)
16204221|NCT01361399|Drug|Lidocain|Single oral application of Lidocain (as lozenge)
16204222|NCT01361399|Drug|Placebo|Single oral application of Placebo (as lozenge)
16204223|NCT01361373|Drug|L- DOPA|Sinemet up to 10 mg/kg/ day increasing gradually for 2 weeks
16204224|NCT01361373|Drug|placebo|placebo for 2 weeks
16204225|NCT01361347|Dietary Supplement|milk|milk for milk allergic children (1:25 dilution, whole milk)
16204226|NCT01361334|Drug|Pazopanib|800 mg QD p.o.
16204227|NCT01361308|Drug|Brisdelle (paroxetine mesylate)|Subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
16204228|NCT01361308|Drug|Placebo capsules|Subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo in a 1:1 ratio, administered once daily at bedtime beginning on Day 1 and continuing up to Day 84
16204229|NCT01361295|Procedure|PVI with PVAC gold|Pulmonary vein isolation using the Medtronic PVAC gold catheter
16204230|NCT01361295|Procedure|PVI with Cooled-RF|Pulmonary vein isolation using the Biosense Webster Navistar Thermocool catheter
16204231|NCT01361269|Drug|Fosmidomycin and clindamycin|The study drugs will be co-administered under supervision by a study physician or nurse in doses of fosmidomycin 30mg/kg/dose + clindamycin 10mg/kg/dose twice daily for three days (total daily dose fosmidomycin 60mg/kg, clindamycin 20mg/kg).
16204232|NCT01361256|Device|Telescope prosthesis|Monocular implantation of the telescope prosthesis after cataract extraction
16204233|NCT01361256|Device|WA-NG Telescope Prothesis|The WA-NG telescope prosthesis (Figure 1) is the next generation telescopic implantable device which, when combined with the optics of the cornea, constitutes a telephoto system for improvement of visual acuity in patients with severe to profound vision impairment due to bilateral, end-stage age-related macular degeneration. The device is implanted in one of the patient's eyes. In this way, the implanted eye provides central vision and the non-implanted eye can continue to provide peripheral vision.
16204234|NCT01361243|Behavioral|NOURISH+|6 week face-to-face parent intervention.
16204235|NCT01361243|Behavioral|Wellness Group|1 week face-to-face family group followed by 6 informational mailings on childhood overweight and obesity.
16204236|NCT01361230|Device|"Sedation Trial Monitor is the name of the device used."|This is a pilot unblinded randomised controlled trial comparing sedation management using responsiveness (new intervention) with usual care (control group).
16204237|NCT01361217|Drug|Fluoxetine, Lovastatin, Omeprazole, caffeine, midazolam, dextromethorphan|"1x20mg oral fluoxetine capsules by mouth daily on Study Day 5, then 3x20mg fluoxetine capsules by mouth daily on Study Days 6 through 18.
~On study day 1 and study day 18, 100mg caffeine, 2mg midazolam, 30mg dextromethorphan and 20mg omeprazole (enteric coated formulation) orally with 250mL of water.
~On study day 3 and study day 20 20mg of lovastatin with 250mL of water."
16204238|NCT01361204|Dietary Supplement|Theanine|Taking 4 tablets of theanine two times daily for 16 days
16204239|NCT01361191|Drug|R-MEGACHOP|"If PET + after third cycle: 2 cycles of R-IFE followed by PBSCT
~If PET - after third cycle: 3 additional cycles of R-MegaCHOP - R-MegaCHOP: cycles every 21 days RITUXIMAB Dosage: 375mg/m2, IV, day 1 CICLOPHOSPHAMIDE Dosage: 1500 mg/m2, IV, day 1 DOXORUBICIN Dosage: 65 mg/m2, IV, day 1 VINCRISTIN: Dosage 1.4 mg/m2 (max. 2.0 mg/m2, IV, day 1 PREDNISONE Dosage: 60 mg/m2, IV, day 1-5
~R-IFE: 2 cycles every 21 days:
~IFOSFAMIDE Dosage: continuous perfusion of 10 gr/m2/iv during 72 hours. Therefore, 3.33 gr/m2/corporal weight 24 hours day +1, +2 and +3.
~ETOPOSIDE Dosage: total 900 mg/m2, IV, which is 150 mg/m2 during 12 hours (days +1, +2 and +3)."
16204310|NCT01360567|Dietary Supplement|Placebo|500 mg . one capsule of placebo, 3 times per day
16204240|NCT01361178|Drug|SQ IVIG|Group 1 will receive SQ IgG at the lower end of the dosing range at 100 mg/kg/week and group 2 will receive SQ IgG at the higher end of the dosing range at 200 mg/kg/week
16204241|NCT01361152|Device|anatomic modular fixed-bearing|anatomic modular (AMK; DePuy) fixed-bearing prosthesis
16204242|NCT01361152|Device|low contact stress rotating platform mobile-bearing|low contact stress rotating platform (LCS RP; DePuy) mobile-bearing prosthesis
16204243|NCT01361126|Biological|Recombinant Coagulation Factor IX Albumin Fusion Protein|Study subjects will receive a single dose of 25IU/kg of rIX_FP for pharmacokinetic analysis. Subjects will then be treated for approximately 5 months. The treatment dose will be based on the subject's PK profile and the subject's bleeding phenotype.
16204244|NCT01361113|Drug|Pazopanib|800 mg orally once daily for 8 weeks, prior to nephrectomy
16204245|NCT01361100|Device|Oncoral® test|The patient rinses his oral cavity for 2 minutes. Then he screws lid back onto a beaker. The investigator holds the beaker straight so that the end of the aspiration mouth is dipped into the liquid. Then, the investigators takes 2 tubes and pushes them one after the other down on the opening of the beaker. The tubes should fill by themselves. The tubes can't be kept more than eleven days and are send to the Clinident Institute for the analysis.
16204246|NCT01361087|Other|Blood draw|This study includes one blood draw to measure circulating blood levels of TGF-B.
16204247|NCT01361074|Behavioral|In Vivo Exposure for Animal Phobia following Öst´s guidelines|"In vivo exposure is applied using one-session treatment guidelines (Öst, Salkovskis and Hellström, 1991). Exposure is conducted in a single extended session lasting up to 3 hours and implemented individually. The treatment includes participant modelling, in vivo exposure, reinforced practice and cognitive challenge. Treatment in a single session is just a starting point; it is recommended that the participants continue to be exposed to the phobic situations after therapy in their daily lives in order to fully surmount their problems. Participants are informed that the treatment required close collaboration between themselves and the therapist. The exposure session is completed in a gradual and planned way."
16204248|NCT01361074|Behavioral|Augmented Reality Exposure for Animal Phobia following Öst´s guidelines|"Augmented Reality (AR) is a variation of Virtual Reality in which the user sees the real world augmented by various virtual elements; it complements reality rather than replacing it completely (Azuma et al., 2001). The most significant aspect of AR is that the virtual elements add relevant and helpful information to the physical information available in the real world. The system includes the options of changing the number, movement and size of small animals. Preliminary data show the utility of the system for the treatment of insect phobia (Botella et al., 2005). AR exposure is applied in the same way than in vivo exposure, that is, in a gradual, planned and controlled way using one-session treatment guidelines (Öst, Salkovskis and Hellström, 1991). The therapist can see what the participant sees in AR on a monitor and observe the same stimuli."
16204249|NCT01361048|Drug|oral metronidazole|2 gm oral once
16204250|NCT01361048|Drug|neo penotran forte|neo penotran forte intravaginal twice a day for 7 days
16204251|NCT01361048|Drug|neo penotran forte once a day|neo penotran forte intravaginally once a day for 7 days
16204252|NCT01361035|Other|Cancer risk communication skills training|Intervention physicians receive training in cancer risk communication and shared decision making (SDM). At the end of each visit with intervention physicians, standardized patients (SPs) reveal themselves as actors and give structured verbal feedback. After baseline SP visits, each intervention physician undergoes academic detailing with a communication expert. Intervention physicians are directed to a web-based communication skills tutorial where SP ratings are hyperlinked to key references for supplemental reading. Both study groups will receive annual reports detailing their patients' cancer screening status and aggregate ratings of their communication style.
16204253|NCT01361022|Drug|Lendormin tablet|Lendormin tablet 250mc is administrated and compared
16204254|NCT01361022|Drug|Brotizolam tablet|Brotizolam tablet 250mc is administrated and compared
16204255|NCT01361009|Drug|pramipexole|as prescibed by the investigator
16204256|NCT01360996|Drug|3 mg DRSP/20 μg EE|1 pill daily-24 days of drospirenone 3 mg (3 mg DRSP)/ethinyl estradiol 20 μg (20 μg EE)/levomefolate calcium 0.451 mg (folate) -followed by 4 days of levomefolate calcium 0.451 mg (folate)only
16204257|NCT01360970|Biological|hepatitis A vaccine ( HAVRIX or EPAXAL)|1.0 ml im ( Havrix) and 0.5 ml im (Epaxal. Both vaccines are given two times with 6 months interval
16204258|NCT01360957|Dietary Supplement|Black cumin water extract as a traditional medicine|to be given orally in a dosage of 30 ml trice daily for 60 days
16204259|NCT01360944|Drug|LAS41004|once daily, topical, 100 microgram
16204260|NCT01360944|Drug|reference|once daily, 100 microgram
16204261|NCT01360918|Device|Epicardial pulmonary vein isolation|After the CABG procedure, a bilateral epicardial pulmonary vein isolation is performed under general anaesthesia and double-lumen endotracheal ventilation.
16204262|NCT01360918|Other|Usual care|Management of atrial fibrillation according to current guidelines using rate control pharmacological therapy.
16204263|NCT01360866|Drug|OPC-34712|Tablet
16204264|NCT01360866|Drug|Escitalopram|Tablet
16204265|NCT01360866|Drug|Fluoxetine|Capsule
16204266|NCT01360866|Drug|Paroxetine CR|Controlled-release tablets
16204267|NCT01360866|Drug|Sertraline|Tablets
16204268|NCT01360866|Drug|Duloxetine|Delayed-release capsules
16204269|NCT01360866|Drug|Venlafaxine XR|Extended-release capsules
16204270|NCT01360853|Drug|ON 01910.Na|ON 01910.Na, 1800 mg/m2 via 2 hr CIV infusions administered twice weekly for 3 weeks of a 4 week cycle.
16204271|NCT01360853|Drug|Gemcitabine|Gemcitabine 1000 mg/m2 weekly for 3 weeks of a 4 week cycle.
16204272|NCT01360853|Drug|Gemcitabine|Gemcitabine, 1000 mg/m2 weekly for 3 weeks of a 4 week cycle.
16204273|NCT01360840|Drug|EMD 525797|Subjects will be administered with EMD 525797 at a dose of 1500 milligram (mg) (diluted with 0.9 percent [%] sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons.
16204274|NCT01360840|Drug|EMD 525797|Subjects will be administered with EMD 525797 at a dose of 750 mg (diluted with 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons.
16204442|NCT01359566|Drug|Arbaclofen placarbil 15 mg BID|arbaclofen placarbil 15 mg BID
16204275|NCT01360840|Other|Placebo|Subjects will be administered with placebo (as 0.9% sodium chloride) as a 1-hour intravenous infusion every 3 Weeks until disease progression or unacceptable toxicity, whichever comes first, unless the subject stopped the trial treatment for other reasons.
16204276|NCT01360840|Other|Standard of Care (SoC)|All the subjects followed the SoC consisting of the continued treatment with luteinizing-hormone releasing hormone agonists (or antagonists).
16204277|NCT01360827|Drug|EMD 1201081 + 5-FU + Cisplatin + Cetuximab|3-6 subjects per cohort will receive EMD 1201081 as a weekly subcutaneous injection on Days 1, 8, and 15 in 3-week cycles at dose levels of 0.16, 0.32, and 0.48mg/kg, respectively until progression of disease, unacceptable toxicity, or subject refusal to continue in the trial. EMD 1201081 will always be given after (within 1 hour) completion of the cetuximab infusion and before the start of chemotherapy.
16204278|NCT01360827|Drug|EMD 1201081 + 5-FU + Cisplatin + Cetuximab|Part 2 seeks to enroll 12 subjects at the MTD of EMD 1201081 in combination with 5-FU/cisplatin + cetuximab; furthermore, an additional 3 to 6 subjects for a total of 9 subjects will be accrued at the 0.16 mg/kg low dose level in Part 2a once the Part 1 0.16 mg/kg dose cohort has been accrued and it is deemed safe to proceed to the 0.32 mg/kg dose cohort. EMD 1201081 will always be given after (within 1 hour) completion of the cetuximab infusion and before the start of chemotherapy.
16204279|NCT01360814|Procedure|quality-of-life assessment|Ancillary studies
16204280|NCT01360814|Behavioral|telephone-based intervention|Receive multidisciplinary structured intervention
16204281|NCT01360814|Other|questionnaire administration|Ancillary studies
16204282|NCT01360814|Other|counseling intervention|Receive multidisciplinary structured intervention
16204283|NCT01360814|Behavioral|exercise intervention|Receive multidisciplinary structured intervention
16204284|NCT01360814|Other|educational intervention|Receive multidisciplinary structured intervention
16204285|NCT01360814|Behavioral|telephone-based intervention|Receive standard care
16204286|NCT01360814|Procedure|standard follow-up care|Receive standard care
16204287|NCT01360788|Drug|Combination ipratropium/salbutamol or placebo (nebulization)|The COPD patients were randomly assigned a combination of ipratropium/salbutamol or a placebo in a double-blind crossover design. The bronchodilation produced by the medication was given in order to evaluate if bronchodilation was effective in increasing exercise tolerance during an endurance shuttle walking test in patients with GOLD stage I COPD.
16204288|NCT01360775|Behavioral|nutritional counseling|Nutritional counseling to caregivers of dependant patients at nutritional risk, Who were participants in the Home Care program conducted by nurses
16204289|NCT01360762|Drug|Pentamidine|Pentamidine isethionate 300 mg for one vial for intramuscular or intravenous route(1 mg of pentamidine isethionate is equivalent to 0.57 mg of pentamidine base)
16204290|NCT01360749|Drug|Lambdalina® (Lidocaine 4% cream)|Lambdaline dose: 2 g for 10 cm2.
16204291|NCT01360749|Drug|Placebo|Placebo dose: 2 g for 10 cm2.
16204292|NCT01360736|Behavioral|Safety Planning - Military (SAFE MIL)|The Safety Planning Intervention (SPI) which is delivered in the SAFE MIL condition aims to help individuals lower their imminent suicide risk by having them collaborate with the study clinician to generate a detailed, hierarchically-arranged action plan for managing suicidal thoughts and urges.
16204293|NCT01360710|Drug|Moxonidine|0.2mg/day for 2 weeks, 0.4mg/day for 6 months
16204294|NCT01360710|Drug|Irbesartan|75 mg/day for 2 weeks and then 150 mg/day for 24 weeks.
16204295|NCT01360697|Other|JADE|"The nurse will complete the CA using standardized protocol including blood & urine tests, eye & feet examination.
~Whenever feasible, the nurse will arrange 2-4 hours of diabetes education in groups or on an individual basis as appropriate.
~Between each follow-up (FU) visit, the nurse or HCA will contact the patient by phone or email to remind them to attend visits, adhere to medications & healthy lifestyles, perform self blood glucose monitoring as appropriate.
~At each FU visit, the patients will first see the nurse or HCA for record of blood pressure, body weight & blood glucose (or A1c) measurement as appropriate. Compliance will also be checked using the 4-item questionnaire.
~After the FU visit, the patients will see the nurse or HCA again to clarify any issues & concerns, reinforce compliance & record any changes in medications.
~After each FU visit, the HCA will generate summary reports to be given to patients & doctors to promote sharing of information."
16204296|NCT01360697|Other|Non-JADE|Patients will receive a comprehensive assessments at baseline and again after 12 months. In the interim between these two time points patients will be managed according to 'usual care' procedures.
16204297|NCT01360671|Drug|Sildenafil|Loading dose of 0.1 mg/kg for 30 minutes followed by maintenance treatment of 0.03 mg/kg.h for up to 14 days
16204298|NCT01360658|Drug|Intravenous immunoglobulins|Single administration of 2 g/kg intravenous immunoglobulins over 2 days
16204299|NCT01360645|Drug|OPC-34712 + ADT|Tablet, Oral, 2 mg OPC-34712 and FDA Approved Antidepressant Therapy (ADT)
16204300|NCT01360645|Drug|Placebo + ADT|Placebo + FDA Approved Antidepressant (ADT)
16204301|NCT01360645|Drug|Placebo + ADT|Placebo + FDA Approved Antidepressant (ADT)
16204302|NCT01360632|Drug|OPC-34712 + ADT|Tablets, Oral, 1 or 3 mg OPC-34712 and FDA Approved Antidepressant Therapy (ADT)
16204303|NCT01360632|Drug|Placebo + ADT|Placebo + FDA Approved Antidepressant (ADT)
16204304|NCT01360632|Drug|Placebo + ADT|Placebo + FDA Approved Antidepressant (ADT)
16204305|NCT01360606|Radiation|Stereotactic Body Radiation Therapy|"SBRT:
~Patients will receive one of the following radiation regimens:
~50 Gy in 5 fractions (10 Gy/fx) delivered over a 2-week period.
~60 Gy in 5 fractions (12 Gy/fx) delivered over a 2-week period.
~75 Gy in 5 fractions (15 Gy/fx) delivered over a 2-week period."
16204306|NCT01360593|Drug|Gemcitabine|"Gemcitabine will be administered for 2 weekly doses every 3 weeks commencing 12 weeks prior to stereotactic radiosurgery as follows:
~Gemcitabine 1,000 mg/m2 IV over 30 minutes on Day 1, and 8 of 21- day cycle. This will be done for up to 4 cycles."
16204307|NCT01360593|Drug|Capecitabine|"Capecitabine will be taken orally twice daily on days 1-14 every 3 weeks for 4 cycles (12 weeks) prior to stereotactic radiosurgery as follows:
~Capecitabine 650 mg/m2 twice daily for days 1-14 every 3 weeks for up to 4 cycles."
16204308|NCT01360593|Radiation|Stereotactic Body Radiation Therapy (SBRT)|"Fractionated SBRT will be delivered to patients that have stable disease, partial response, or complete response after chemo in the following manner:
~12 Gy x 3 fractions (36 Gy total) This will be given every other day."
16204309|NCT01360567|Dietary Supplement|Green tea extract|500 mg . one capsule of green tea extract, 3 times per day
16204311|NCT01360554|Drug|Dacomitinib (PF-00299804)|Dacomitinib (PF-00299804) is provided as 45 mg tablets, continuous oral daily dosing
16204312|NCT01360554|Drug|Active Comparator (erlotinib)|Active comparator (erlotinib) provided as 150 mg tablet, continuous oral daily dosing
16204313|NCT01360554|Drug|Placebo erlotinib|placebo erlotinib, provided as 150 mg tablet, continuous oral daily dosing.
16204314|NCT01360554|Drug|Placebo PF00299804|placebo PF-00299804, provide as 45 mg tablet, continuous oral daily dosing
16204315|NCT01360541|Procedure|Endoscopic radiofrequency ablation|HALO device Use of HALO 360° device for the fist procedure and possible use of HALo 90° device for further treatment sessions Treatment zone of 12cm high maximum. Energy delivered 10 J/cm², power 300W
16204316|NCT01360541|Other|Endoscopic surveillance|Upper gastro-intestinal endoscopy every 6 to 12 month under propofol sedation with acetic acid magnification of mucosa and multiple biopsy samples.
16204317|NCT01360476|Dietary Supplement|cholecalciferol (Vitamin D)|50,000 UI, chewable wafer every 2 weeks for 52 weeks (27 total doses)
16204318|NCT01360476|Dietary Supplement|Placebo|chewable wafer every 2 weeks for 52 weeks (27 total doses)
16204319|NCT01360463|Behavioral|Behavioral Drug and Risk Counseling (BDRC)|"The BDRC counseling is rooted in cognitive behavioral theory. During one hour sessions, the counselors help participant identify short term behavioral goals and work with the participant to develop strategies to achieve their goals. These plans are referred to as contracts and these contracts are reviewed and revised at each subsequent session."
16204320|NCT01360463|Behavioral|methadone maintenance treatment|daily individualized doses of methadone will be provided by the program staff.
16204321|NCT01360450|Drug|Clonidine HCL|At day 5 on opioid and/or benzodiazepine (BZD), the infant will be randomized to receive either placebo (normal saline) or clonidine 1μg/kg/q 4 hrs to a maximum dose of 2μg/kg/q 4. Weaning from the study drug: When the opioid is no longer required, 24 hrs later the study drug (placebo or study drug) will be reduced by 50% and then discontinued 24 hours later provided that the Modified Finnegan scores remain between < 9.
16204322|NCT01360450|Drug|saline|Infants randomized to placebo will be administered IV saline or oral sterile water in the same volume as study drug. The placebo will be give every 4 hrs as outlined in the algorithm for the study.
16204323|NCT01360437|Drug|Prasugrel|Prasugrel 10mg/day
16204324|NCT01360437|Drug|Ticagrelor|Ticagrelor 90mg twice a day
16204325|NCT01360424|Drug|Teriparatide|Daily administration of teriparatide 20 ug s.c. for 24 months
16204326|NCT01360398|Procedure|Blood sample|Blood samples will be collected from all patients at enrolment, at follow-up visits, at exacerbation visits, and during the final visit.
16204327|NCT01360398|Procedure|Sputum sample|Sputum will be collected from all patients at enrolment, at monthly follow-up visits, at exacerbation visits, and during the final visit. Sputum will be obtained by spontaneous expectoration or induced by stimulation according to standard methods.
16204328|NCT01360398|Procedure|Nasopharyngeal swab|Nasopharyngeal swabs will be collected from all patients at enrolment and from a subcohort of 30 patients at monthly follow-up visits and at exacerbation visits during the first year.
16204329|NCT01360398|Procedure|Urine sample|Urine samples will be taken at enrolment and exacerbation visits from all subjects and from the same subcohort of 30 patients providing nasopharyngeal swabs, at monthly follow-up visits during the first year.
16204330|NCT01360398|Procedure|End tidal breath sample|Breath samples will be collected from all patients at enrolment, at follow-up visits (monthly), at exacerbation visits, and during the final visit.
16204331|NCT01360398|Other|Data collection|Patient interview, diary cards review and questionnaires completion
16204332|NCT01360398|Other|Tests|Urine pregnancy test, chest CT-scan, lung function testing and 6-min walk test
16204333|NCT01360372|Drug|Methylnaltrexone|Methylnaltrexone 8 mg IV for subjects 38 to 62 kg body weight, Methylnaltrexone12 mg IV for subjects 62.1 to 114 kg body weight
16204334|NCT01360372|Drug|Saline injection|Saline 0.4 to 0.8 ml injection
16204335|NCT01360359|Other|Core Stabilization|"3 Stages: Stage 1: emphasis on neutral spine position, co-contraction of stabilizing muscles with performance feedback through observation and palpation for correct muscle activation; patient education
~Stage 2: promotes maintenance of co-contraction while performing movements of the arms/legs and trunk progressing to preformance of these exercises on unstable surfaces; trunk muscle conditioning also emphasized; feedback gradually reduced.
~Stage 3: emphasis on maintenance of co-contraction while performing functional activities; stable and unstable surfaces; use of perturbation and random practice to enhance motor learning."
16204336|NCT01360359|Other|Trunk Motion and Fitness|"3 Stages: Stage 1: reducing pain and restoring spine motion and flexibility; patient education
~Stage 2: trunk muscle conditioning exercises
~Stage 3: trunk muscle conditioning and cardiovascular conditioning exercises"
16204337|NCT01360346|Procedure|Enteral Sedation (EN)|Intravenous propofol or midazolam administration at the ICU admission and stopped within 48h. Melatonin by enteral route (3mg x 2/die) from admission to discharge. Hydroxyzine by enteral route from ICU admission (600mg/die), decreased and stopped as soon as possible. Lorazepam supplementation (maximum 16mg/die) if hydroxyzine is inadequate.
16204338|NCT01360346|Procedure|Control group: Intravenous Sedation (IV)|Propofol or midazolam from ICU admission to discharge at the compatible lowest level with harsh ICU environment.
16204339|NCT01360333|Other|tap water, sodium chloride, carbohydrate rich fluid|Ingestion of three different fluids at three different occasions separated by at least one week, A, Tap water. B. Sodium Chloride. C. Carbohydrate rich fluid.
16204340|NCT01360320|Dietary Supplement|Green tea extract of Camellia Sinensis|"Powdered decaffeinated green tea extract of Camellia Sinensis, packed in hard gelatine capsules containing either 150 mg EGCG
~Run-in period with 150mg EGCG two times daily (p.o) for 4 weeks
~150mg EGCG two times daily (p.o.) over the course of three years.
~Colonoscopy after 3 years"
16204341|NCT01360320|Dietary Supplement|Green tea extract of Camellia Sinensis followed by placebo|"Powdered decaffeinated green tea extract of Camellia Sinensis, packed in hard gelatine capsules containing either 150 mg EGCG
~Run-in period with 150mg EGCG two times daily (p.o.) for 4 weeks
~Placebo two times daily (p.o.) over the course of three years
~Colonoscopy after 3 years"
16204342|NCT01360281|Other|Neuromuscular Electrical Stimulation|
16204343|NCT01360281|Other|ECR|Resisted exercises
16204443|NCT01359566|Drug|Placebo|Placebo for arbaclofen placarbil 15, 30 and 45 mg BID
16204448|NCT01359553|Other|Quantitative MRI imaging of knee|
16204344|NCT01360242|Procedure|MIMI procedure (two-step strategy)|A second coronary angiogram is performed 24-48 hours later and the physician is free to decide on the best treatment, i.e. surgery, medical treatment, or stent implantation (drug-eluting stent if indicated for on-label patients). If stenting is required and the thrombus is still too large (greater than twice the artery width), the physician could postpone stent implantation for days or weeks.
16204345|NCT01360242|Procedure|Immediate Stenting (one-step strategy)|The physician is encouraged to implant a stent after the thrombus aspiration (drug-eluting stent if indicated for on-label patients).
16204346|NCT01360229|Procedure|Acupuncture|Subjects will be randomized in a 1:1 ratio to receive real acupuncture. Acupuncture is a procedure in which specific body areas are pierced with fine needles for therapeutic purposes
16204347|NCT01360229|Other|Acupuncture to treat fatigue in Parkinson disease|Subjects will be randomized in a 1:1 ratio to receive sham acupuncture.
16204348|NCT01360216|Behavioral|LARC education and training|A CME/CEU accredited Grand Rounds education and training session will be given to clinicians and contraceptive educators practicing in clinics assigned to the intervention arm. Clinicians will have hands-on training as well. The half-day session emphasizes evidence-based contraceptive counseling and provision.
16204349|NCT01360203|Other|Structured Telephone / Remote Outpatient Monitoring|During their hospitalization, patients will receive education on their condition and will be taught to use a wireless remote monitoring device that they will use from home on a daily basis for six months following hospital discharge. Patients will receive structured telephone phone calls from a centralized call center nurse at least once a week for the first month post-discharge, and monthly for the remainder of the six month study period. Patients may receive additional calls depending upon the information gathered during the scheduled call center phone calls and/or their health status as ascertained by the data (weight, heart rate, blood pressure, answers to general health and heart failure-related questions) transmitted daily by the wireless remote monitoring device.
16204350|NCT01360190|Drug|fluoxetine|fluoxetine 20 mg. daily
16204351|NCT01360177|Procedure|124 PET/CT imaging|Standard of Care
16204352|NCT01360177|Drug|Na134I|25 to 150 mCi
16204353|NCT01360177|Drug|Tri-iodothyronine|75 ug/8hr x 4 weeks; oral
16204354|NCT01360177|Drug|Tri-iodothyronine|20 mg/day x 2
16204355|NCT01360164|Biological|human umbilical cord mesenchymal stem cells|Participants will be given hUC-MSCs transplantation.
16204356|NCT01360151|Drug|ranibizumab(Lucentis), verteporfin(Visudyne)|ranibizumab(Lucentis) : 0.5mg/0.05ml - intravitreal injection verteporfin (Visudyne) : 15mg (6mg/m2)- intravenous injection
16204357|NCT01360138|Procedure|Cervical epidural steroid injection|cervical epidural steroid injection with a solution (5 ml) containing 10 mg triamcinolone acetonide suspension, 1.5 ml of 0.75% levobupivacaine hydrochloride, and 3.5 ml of normal saline (0.9% NaCl)
16204358|NCT01360125|Genetic|proteomic profiling|
16204359|NCT01360125|Other|flow cytometry|
16204360|NCT01360125|Other|laboratory biomarker analysis|
16204361|NCT01360086|Biological|cetuximab|6 cycles of intravenous Cetuximab (500mg/m²),
16204362|NCT01360086|Drug|cisplatin|Cisplatine (50mg/m²)
16204363|NCT01360086|Drug|fluorouracil|LV5FU2s (folinic acid 400mg/m², 5FU bolus 400mg/m², and continuous infusion of 5FU 2400mg/m²) every 2 weeks
16204364|NCT01360086|Drug|leucovorin calcium|
16204365|NCT01360086|Procedure|adjuvant therapy|
16204366|NCT01360086|Procedure|neoadjuvant therapy|
16204367|NCT01360086|Procedure|quality-of-life assessment|
16204368|NCT01360086|Procedure|therapeutic conventional surgery|Surgery was planned 3-4 weeks after the end of neaodjuvant CT
16204369|NCT01360060|Drug|Magnesium Sulphate|Magnesium sulphate was infused for the management of preeclampsia at perioperative period.
16204370|NCT01360034|Drug|Nifedipine|Nifedipine: 20 mg as a single dose upon admission and then 10 mg vo every 8 hours for 48 hours.
16204371|NCT01360034|Drug|Indomethacin|Indomethacin: 50 mg vo as a single dose upon admission and then 25 mg vo every 6 hours for 48 hours.
16204372|NCT01360021|Drug|Symbicort|Breath actuated metered dose inhaler
16204373|NCT01360021|Drug|Symbicort|Actuation counter pressured metered dose inhaler
16204374|NCT01360021|Drug|Budesonide|Actuation counter pressured metered dose inhaler
16204375|NCT01359982|Drug|RRx-001|Dose level 1 (10 mg/m2)
16204376|NCT01359982|Drug|RRx-001|Dose Level 2 (16.7 mg/m2)
16204377|NCT01359982|Drug|RRx-001|Dose Level 3 (24.6 mg/m2)
16204378|NCT01359982|Drug|RRx-001|Dose Level 4 (33 mg/m2)
16204379|NCT01359982|Drug|RRx-001|Dose Level 5 (55.0 mg/m2)
16204380|NCT01359982|Drug|RRx-001|Dose Level 6 (83 mg/m2)
16204381|NCT01359969|Drug|rhC1INH|Patients up to 84 kg will receive one i.v. injection of Ruconest at a dose of 50 U/kg. The reconstituted solution should be administered as a slow i.v. injection over approximately 5 minutes. Patients of 84 kg body weight or greater will receive one i.v. injection of Ruconest at the dose of 4200 U (2 vials).
16204382|NCT01359956|Drug|Dacarbazine|900 mg / m2 every 3 weeks
16204383|NCT01359956|Drug|Fotemustine|100 mg / m2 every 3 weeks
16204384|NCT01359956|Drug|Interferon Alfa-2b|5 M units every 3 weeks
16204385|NCT01359943|Biological|secukinumab (AIN457)|"Secukinumab is a human monoclonal antibody. Monoclonal antibodies are proteins that recognize and bind to unique proteins that your body produces. Secukinumab binds and reduces the activity of a cytokine (a messenger protein in the body) called Interleukin 17 (IL-17)."
16204386|NCT01359943|Drug|placebo|Matching placebo to AIN457 i.v. and to AIN457 s.c..
16204387|NCT01359930|Other|placebo|matching placebo
16204388|NCT01359930|Drug|Naltrexone and Bupropion SR|25mg bid/day (NX) 200mg bid/day (BUP)
16204389|NCT01359904|Other|High Dialysate bath|The dialysate bath assigned is 10mmol/L glucose, while the control group is assigned to 5.5 mmol/l glucose solution.
16204390|NCT01359878|Drug|Fibrinogen Concentrate|2 gram intra venous
16204391|NCT01359878|Drug|Isotonic Saline|Isotonic saline in equivalent volume - 100 ml
16204444|NCT01359566|Drug|Arbaclofen placarbil 30 mg BID|arbaclofen placarbil 30 mg BID
16204445|NCT01359566|Drug|Arbaclofen placarbil 45 mg BID|arbaclofen placarbil 45 mg BID
16204446|NCT01359553|Other|Intra-articular ultrasound imaging of knee joint during arthroscopy|
16204447|NCT01359553|Other|Non-invasive ultrasound imaging of knee|
16204392|NCT01359865|Procedure|Lumbar Plexus Block|lumbar plexus block followed by a general anesthetic. The lumbar plexus block will be performed by an attending anesthesiologist using ultrasound guidance (for measuring the depth of the psoas compartment) and nerve stimulation. A standardized block solution of 30 mL 0.5% ropivacaine will be injected in fractionated doses when a quadriceps muscle twitch is present to nerve stimulation at <0.50 mA. Fifteen minutes after block completion, the block's effectiveness will be evaluated with an ice test.
16204393|NCT01359852|Drug|[11C] JNJ-42491293|Part B:[11C] JNJ-42491293 (300 to 370 MBq) will be dosed as an i.v. bolus injection, have a 90 minute PET scan and have arterial and venous blood sampling.
16204394|NCT01359852|Drug|[11C] JNJ-42491293 + JNJ-40411813|Part C:[11C] JNJ-42491293 (300 to 370 MBq) will be dosed as an i.v.bolus injection. Volunteers will be pre-treated with JNJ-40411813 between 1.5 to 3 hours prior to the second and prior to the third PET scan
16204395|NCT01359852|Drug|[11C] JNJ-42491293 + JNJ-40411813|"Part D:[11C] JNJ-42491293 (300 to 370 MBq) will be dosed as an i.v. bolus injection.
~Volunteers will be treated with a single dose of up to 500 mg JNJ-40411813 prior to the second scan and will have a third scan at least 2 hours later to evaluate the rate of clearance of JNJ-40411813 from the brain"
16204396|NCT01359852|Drug|[11C] JNJ-42491293|Part A: [11C] JNJ-42491293 (300 to 370 MBq) will be dosed as an i.v. bolus injection and have a 120 minute PET scan.
16204397|NCT01359839|Behavioral|Relaxation Response and Cognitive Behavioral Therapy|This is a group format which will meet once per week and teach the techniques of cognitive behavioral therapy as well as relaxation response meditation.
16204398|NCT01359826|Drug|Milnacipran|After dose escalations, patients will receive Milnacipran administered at 50 mg twice a day after for 12 weeks or milnacipran 50 mg twice day for 4 weeks and then 100 mg twice a day for an additional 6 weeks depending on tolerability and fatigue response.
16204399|NCT01359813|Drug|Human Albumin|Administration: 1,5 g/kg at Day 1 and 1g/kg at Day 3 In case of a new infection appears in the 3 months, the same doses will be administrated.
16204400|NCT01359787|Drug|Mapracorat|Daily topical application
16204401|NCT01359787|Drug|Vehicle without active|Daily topical application
16204402|NCT01359774|Other|31P-MR spectroscopy|Brain energy deficit is quantified using 31P-MR spectroscopy
16204403|NCT01359774|Other|31P-RMN spectroscopy|Brain energy deficit is quantified using 31P-RMN spectroscopy
16204404|NCT01359761|Behavioral|Post Admission Cognitive Therapy (PACT)|Six (60-90 minutes) individual psychotherapy sessions administered over preferably 3 days of inpatient stay, up to 2 booster sessions during hospitalization, and 4 telephone booster sessions within 3-months post discharge
16204405|NCT01359748|Device|Reference sphygmomanometer|* USED Audible Korotkoff (K5)for Auscultatory sphygmomanometer.
16204406|NCT01359748|Device|Sphygmomanometer under test|Electronic Oscillometric method.
16204407|NCT01359735|Biological|HP802-247|High dose HP 802-247, applied at each visit (Week 1-13) or until healed
16204408|NCT01359735|Biological|Bacitracin Ointment|One dose of Bacitracin ointment consists of 50 units/1 gram. This will be applied daily for 12 weeks (or until healed).
16204409|NCT01359722|Drug|N-acetylcysteine|N-acetylcysteine is administered at a dose of 150mg/kg in 500mL of saline EV in 1 hour followed by a dose of 50mg/kg in 500 mL of saline IV within 6 hours, beginning the infusion together to surgery.
16204410|NCT01359722|Drug|Control|The control group will receive only the infusion of saline in the same doses and infusion rate.
16204411|NCT01359709|Drug|Nicotine polacrilex|Participants will apply Nicoderm (14 mg) patches everyday during this study.
16204412|NCT01359696|Drug|GDC-0425|Oral escalating dose
16204413|NCT01359696|Drug|gemcitabine|Intravenous repeating dose
16204414|NCT01359683|Device|Dataq Instruments DI-158|Data Acquisition Device (connects to room instrumentation)
16204415|NCT01359670|Drug|Tadalafil|Escalating dose (0.25 mg/kg, 0.5 mg/kg, 1.0 mg/kg; once daily) over 2 weeks
16204416|NCT01359670|Drug|Sildenafil|Escalating dose (0.25 mg/kg, 0.5 mg/kg, 1.0 mg/kg; four times daily) over 2 weeks
16204417|NCT01359657|Biological|Anti-CXCR4 (BMS-936564)|Solution, Intravenously, 1-10 mg/kg, Single 60 minute infusion once a week, 42 days (cycle 1) 28 days subsequent cycles
16204418|NCT01359657|Biological|Lenalidomide|Tablets, per os (by mouth route of administration) (P.O), 25 mg, daily for 21 days (Day 15-35 in cycle 1; Day 1-21 in subsequent cycles), no dosing in Cycle 1, Cycle 2 +:daily dosing from Day 1-21
16204419|NCT01359657|Biological|Dexamethasone|Tablets, per os (by mouth route of administration) (P.O), 40 mg, administered with Lenalidomide once every 7 days, 42 days (cycle 1) 28 days subsequent cycles
16204420|NCT01359657|Biological|Anti-CXCR4 (BMS-936564)|Solution, Intravenously, 1-10 mg/kg, Single 60 minute infusion once a week, 35 days (cycle 1) 21 days subsequent cycles
16204421|NCT01359657|Biological|Bortezomib|Intravenous (IV), 1.3 mg/m2, administered on day 15, 18, 22, 25 in cycle 1, then on Day 1, 4, 8, 11 in subsequent cycles, no dosing in Cycle 1, Cycle 2 +:dosing on Day 1, 4, 8, 11
16204422|NCT01359657|Biological|Dexamethasone|Tablets, per os (by mouth route of administration) (P.O), 40 mg, administered on the day of (and the day after) Bortezomib infusion, 35 days (cycle 1) 21 days subsequent cycles
16204423|NCT01359644|Drug|PSI-7977|Tablets, oral, 400 mg, once daily
16204424|NCT01359644|Drug|Daclatasvir|Tablets, oral, 60 mg, once daily
16204425|NCT01359644|Drug|Ribavirin|Tablets, oral, 200 mg
16204426|NCT01359618|Drug|TC-5214|Single dose, oral tablets
16204427|NCT01359618|Other|Placebo comparator|Single dose, oral tablets
16204428|NCT01359618|Drug|Moxifloxacin|Single dose, oral encapsulated tablet
16204429|NCT01359618|Other|Moxifloxacin placebo comparator|Single dose, oral encapsulated tablet
16204430|NCT01359605|Drug|varespladib methyl|500 mg oral suspension
16204431|NCT01359592|Biological|rituximab|
16204432|NCT01359592|Drug|cyclophosphamide|
16204433|NCT01359592|Drug|doxorubicin hydrochloride|
16204434|NCT01359592|Drug|prednisone|
16204435|NCT01359592|Drug|vincristine sulfate|
16204436|NCT01359592|Other|R-CHOP regimen|
16204437|NCT01359592|Other|laboratory biomarker analysis|
16204438|NCT01359592|Radiation|fludeoxyglucose F 18|
16204439|NCT01359592|Radiation|selective external radiation therapy|
16204440|NCT01359592|Radiation|yttrium Y 90 ibritumomab tiuxetan|
16204441|NCT01359579|Drug|varespladib methyl|Single oral 500 mg dose
16204449|NCT01359553|Other|Contrast-enhanced CT imaging of knee|
16204450|NCT01359540|Device|OMNI Apex Modular™ Hip Device|
16204451|NCT01359540|Device|OMNI Apex ARC™ Hip Device|
16204452|NCT01359527|Device|Hip Resurfacing|
16204453|NCT01359527|Device|Total Hip Arthroplasty|
16204454|NCT01359514|Drug|Pregabalin|Initial dose of 75x2mg/d for one week, and then fixed dose of 150x2mg/d for the following 5 weeks
16204455|NCT01359514|Drug|Duloxetine|Initial dose of 30 mg/d will be given for one week, in order to minimize possible side effects and drop outs, and then a fixed dose of 60 mg/d will be given for additional 5 weeks
16204456|NCT01359501|Drug|Chinese medical treatment-LCH1|Start to take the powder of Chinese herb-LCH1 3g*BID just after the 1st chemotherapy, and Stop 2-3 weeks after the final cycle of chemotherapy.
16204457|NCT01359501|Drug|Placebo|Start to take the powder of Placebo 3g*BID just after the 1st chemotherapy, and stop 2-3 weeks after the final chemotherapy.
16204458|NCT01359488|Drug|VRS-317|VRS-317 Single Dose
16204459|NCT01359488|Drug|VRS-317|VRS-317 Single Dose
16204460|NCT01359488|Drug|VRS-317|VRS-317 Single Dose
16204461|NCT01359488|Drug|VRS-317|VRS-317 Single dose
16204462|NCT01359488|Drug|VRS-317|VRS-317 Single dose
16204463|NCT01359475|Procedure|Acetal crown, LD Caulk ltd, USA|Experimental trial of preformed acetal crowns for primary molars
16204464|NCT01359462|Drug|tolvaptan|"Drug: tolvaptan
~tablet, 15mg, Qd, for 7 days."
16204465|NCT01359449|Biological|Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate: Menactra®|0.5 mL, Intramuscular
16204466|NCT01359449|Biological|Meningococcal Group C Conjugate vaccine: MenC|0.5 mL, Intramuscular
16204467|NCT01359436|Device|Electrosensing antibody probing system (e- Ab sensing)|Electrosensing antibody probing system (e- Ab sensing), which was developed for the rapid and sensitive detection of hapten, proteins or viral antigen in medical samples, will be used for analyzing the interaction kinetics between mutation-specific anti-EGFR and its antigen mutant EGFR present in NSCLC. The system incorporates the use of engineered semiconductive antibodies or virus in vertical and lateral chip (eAbchip) or lateral flow through (eAbsignal) formats. In electrosensing antibody probing, semiconductive antibodies are bound as a suitable electrosensing probe which specifically and selectively binds mutant EGFR polypeptide target molecules in the test specimen.
16204468|NCT01359423|Drug|Percutaneous transluminal angioplasty of femoropopliteal artery lesions with primary long|Patients will be randomized in a two-by-two factorial manner according to the use of IVUS guidance (IVUS guidance vs. no IVUS guidance) for the PCI and the duration of dual anti-platelet therapy (100 mg/day aspirin and 75mg/day clopidogrel for 6 months vs. 12 months) after PCI. Each randomization of the enrolled subjects will be done 1:1.
16204469|NCT01359423|Drug|short stenting for the primary outcome and use of cilostazol for 12 months for secondary outcome.|Patients will be randomized in a two-by-two factorial manner according to the use of IVUS guidance (IVUS guidance vs. no IVUS guidance) for the PCI and the duration of dual anti-platelet therapy (100 mg/day aspirin and 75mg/day clopidogrel for 6 months vs. 12 months) after PCI. Each randomization of the enrolled subjects will be done 1:1.
16204470|NCT01359410|Device|Mesh reinforced staple line (SEAMGUARD)|Reinforce the pancreatic transaction with SEAMGUARD®
16204471|NCT01359410|Device|Stapled without mesh reinforcement (PER-STRIPS DRY)|Stapled without mesh reinforcement (PERI-STRIPS DRY®)
16204472|NCT01359397|Drug|Docetaxel, Oxaliplatin, Capecitabin, Bevacizumab|Her2 - patients only
16204473|NCT01359397|Drug|Docetaxel, Oxaliplatin, Capecitabin, Bevacizumab, Trastuzumab|for Her2 + patients only
16204474|NCT01359371|Behavioral|Peer telephone cessation counseling|For Veterans who received the inpatient Tobacco Tactics intervention, trained volunteers initiated follow-up telephone cessation counseling at 2, 14, 21 and 60 days after in-patient discharge; three attempts were made per time point.
16204475|NCT01359345|Drug|gadollinum|use of on injection gadollinum Iv for imaging
16204476|NCT01359332|Procedure|Moderate hypothermia|procedure of moderate hypothermia therapy, between 32 ° and 34 ° C for 24 hours
16204477|NCT01359319|Drug|Sialic Acid Extended Release (SA-ER) Tablets|Patients will receive SA-ER tablets orally at one of five (5) dose levels in the single-dose phase,phase and one of four (4) dose levels in the repeat-dose phase. During repeat dosing, the total daily dose will be divided evenly into three doses given in the morning, in the evening, and at bedtime (qHS). No placebo or active comparator will be administered and the study drug will be administered on an open-label basis.
16204478|NCT01359319|Drug|Sialic Acid Extended Release (SA-ER) Tables|PPatients will receive SA-ER tablets orally at one of five (5) dose levels in the single-dose phase,phase and one of four (4) dose levels in the repeat-dose phase. During repeat dosing, the total daily dose will be divided evenly into three doses given in the morning, in the evening, and at bedtime (qHS). No placebo or active comparator will be administered and the study drug will be administered on an open-label basis.
16204479|NCT01359319|Drug|Sialic Acid Extended Release (SA-ER) Tablets|Patients will receive SA-ER tablets orally at one of five (5) dose levels in the single-dose phase,phase and one of four (4) dose levels in the repeat-dose phase. During repeat dosing, the total daily dose will be divided evenly into three doses given in the morning, in the evening, and at bedtime (qHS). No placebo or active comparator will be administered and the study drug will be administered on an open-label basis.
16204480|NCT01359319|Drug|Sialic Acid Extended Release (SA-ER) Tablets|Patients will receive SA-ER tablets orally at one of five (5) dose levels in the single-dose phase,phase and one of four (4) dose levels in the repeat-dose phase. During repeat dosing, the total daily dose will be divided evenly into three doses given in the morning, in the evening, and at bedtime (qHS). No placebo or active comparator will be administered and the study drug will be administered on an open-label basis.
16204481|NCT01359319|Drug|Sialic Acid Extended Release (SA-ER) Tablets|Patients will receive SA-ER tablets orally at one of five (5) dose levels in the single-dose phase,phase and one of four (4) dose levels in the repeat-dose phase. During repeat dosing, the total daily dose will be divided evenly into three doses given in the morning, in the evening, and at bedtime (qHS). No placebo or active comparator will be administered and the study drug will be administered on an open-label basis.
16204482|NCT01359280|Behavioral|Adherence Counseling|5 Sessions of theory-based medication adherence counseling
16204483|NCT01359280|Behavioral|General Health Counseling|5 sessions of health improvement counseling
16204870|NCT01356290|Drug|Thalidomide|3mg/kg, oral, daily, 1 year
16204484|NCT01359280|Behavioral|Text Messages|Daily medication regimen tailored adherence reminders delivered by cell phone
16204485|NCT01359267|Drug|99mTc-EC-DG|99mTc-EC-DG will be used before the SPECT/CT scans throughout the study to determine the its effectiveness. 20 mCi of 99mtc-EC-DG will be administered through a vein through a catheter. This will be done before the SPECT/CT scan at 4 weeks and 10 weeks.
16204486|NCT01359254|Drug|Melphalan|Melphalan is given daily for 2 days, overlapping with the completion of fludarabine.
16204487|NCT01359254|Drug|Fludarabine|Fludarabine is given through the vein daily for 5 days.
16204488|NCT01359254|Drug|Antithymocyte Globulin (ATG)|ATG is given every other day for 4 days.
16204489|NCT01359254|Drug|Busulfan|Busulfan is given daily for 4 days.
16204490|NCT01359254|Drug|Total Body Irradiation (TBI)|TBI is given twice on the last day.
16204491|NCT01359241|Procedure|closed-loop insulin delivery|Insulin delivery via subcutaneous pump, adjusted according to computer-based algorithm advice, based on continuous glucose sensor readings
16204492|NCT01359241|Drug|Usual diabetes treatment regimen|Usual non-insulin glucose lowering medications
16204493|NCT01359228|Drug|Rifaximin (XIFAXAN)|Rifaximin (XIFAXAN®) 1650 mg/day (550 mg tablet three times a day) for 14 days
16204494|NCT01359228|Drug|Placebo|Placebo 1 tablet three times a day for 14 days.
16204495|NCT01359202|Biological|rfVIIa|80ug/kg IV bolus
16204496|NCT01359202|Other|Standard saline solution|Saline
16204497|NCT01359189|Device|ProxiScan (scintigraphic rectal probe)|"ProxiScanTM is a compact, high-resolution gamma camera which has been developed for the detection of cancer and other abnormalities in the body by imaging the distribution of radionuclides in the human body using planar imaging techniques. This camera is capable of high-performance imaging of radiopharmaceuticals distributed within anatomical regions of interest located close to the camera head. The ProxiScan compact scintigraphic detector was approved by the FDA to market the device for the following indication: The ProxiScanTM is indicated for use in imaging the distribution of radionuclides in the human body using planar imaging techniques. ProxiScanTM may also be used intraoperatively, on pathological specimens and for endocavity applications if a protective sheath is used."
16204498|NCT01359163|Drug|etynodiol diacetate|tablet, 0.5 mg, single dose
16204499|NCT01359163|Drug|etynodiol diacetate|tablet, 0.5 mg, single dose
16204500|NCT01359150|Drug|CP-690,550|Treatment Group 1: 10 mg BID CP-690,550 (100 subjects). Strata 1: 10 mg BID CP-690,550 on background methotrexate (50 subjects); Strata 2: 10 mg BID CP-690,550 monotherapy (50 subjects).
16204501|NCT01359150|Drug|placebo|Placebo CP-690,550 (100 subjects). Strata 1: Placebo CP-690,550 on background methotrexate (50 subjects); Strata 2: Placebo CP-690,550 monotherapy (50 subjects). Influenza and pneumococcal vaccines will be administered to all subjects
16204502|NCT01359137|Behavioral|Probation as usual|Routine probation with do deferred jail condition.
16204503|NCT01359137|Behavioral|Deferred Jail|Discretionary deferred jail in response to violations of probation conditions.
16204504|NCT01359137|Behavioral|Arizona's SAFE|Swift Accountable Fair Enforcement (SAFE) uses non-discretionary brief jail sanctions for probation violations.
16204505|NCT01359124|Behavioral|Exercise Cycle|Exercise regimen: three monitored exercise sessions per week for eight weeks using the upright exercise cycle.
16204506|NCT01359124|Behavioral|Land-based Treadmill|Exercise regimen: three monitored exercise sessions per week for eight weeks using the land-based treadmill.
16204507|NCT01359124|Behavioral|Water-based Treadmill|Exercise regimen: three monitored exercise sessions per week for eight weeks using the water-based treadmill.
16204508|NCT01359111|Device|PATH ID Adapter|Intradermal delivery device which fits on the end of a syringe to limit the depth and angle of needle penetration into the skin.
16204509|NCT01359098|Drug|Ciprodex Otic Suspension|4 gtt b.i.d. for 7 days.
16204510|NCT01359098|Drug|Ciprodexa Otic Foam|0.3% Ciprofloxacin, 0.1% Dexamethasone Otic Foam, 1 actuation, q.d. for 7 days
16204511|NCT01359085|Drug|Pregabalin|Pregabalin 75 mg will be given orally as premedication at the night before surgery (at bedtime). Pregabalin 150 mg will be administered orally at 1h preoperatively and at 12h and 24h postoperatively.
16204512|NCT01359085|Procedure|ISBPB - interscalene brachial plexus block|ISBPB will be performed by an anesthesiology consultant experienced in performing the procedure, after the induction of GA. Block will be performed under sterile conditions by injection of 40ml 0.5% bupivacaine with epinephrine 1:100,000 to the plexus sheath through a 5-cm, 23-gauge short-beveled needle.
16204513|NCT01359072|Other|Self administered coping intervention|The self administered coping intervention (i.e. NUCARE workbook) aims to teach individuals how to cope with their cancer. The intervention embraces two major areas: (i) the enhancement of a sense of personal control; and (ii) the learning of emotional and instrumental coping responses. The approach emphasizes training in problem-solving, relaxation techniques, cognitive coping skills, goal setting, communication, social support and lifestyle factors. The didactic material of the Nucare program is comprised of a workbook containing 12 chapters addressing the above mentioned aspects.
16204514|NCT01359059|Drug|Pregabalin|Patients in one set (40 patients/set) will receive 150 mg of PGL or placebo at 20:00 the evening before surgery and 1.5 h before surgery and will undergo surgery under GA. The 2nd set of patients will be randomized similarly but will undergo surgery under epidural analgesia. One physician whose duty in the study will end at the point of preoperative preparation will provide the patients with the preemptive drug. No other premedication will be administered to any patient. Post-operatively, patients who received preoperative PGL patients will be given placebo while the pre-surgery-placebo-treated ones will receive PGL, all at 2 h after surgery. All patients will then be given 150 mg twice daily thereafter, Q 12 h postoperatively up to 96 h.
16204515|NCT01359059|Drug|Pregabalin|Patients in one set (40 patients/set) will receive 150 mg of PGL or placebo at 20:00 the evening before surgery and 1.5 h before surgery and will undergo surgery under GA. The 2nd set of patients will be randomized similarly but will undergo surgery under epidural analgesia. One physician whose duty in the study will end at the point of preoperative preparation will provide the patients with the preemptive drug. No other premedication will be administered to any patient. Post-operatively, patients who received preoperative PGL patients will be given placebo while the pre-surgery-placebo-treated ones will receive PGL, all at 2 h after surgery. All patients will then be given 150 mg twice daily thereafter, Q 12 h postoperatively up to 96 h.
16204516|NCT01359046|Device|silver SPC|subject randomized to receive silver alloy impregnated catheter
16204517|NCT01359046|Device|standard SPC|subject randomized to receive standard catheter
16204518|NCT01359020|Drug|ibuprofen, dipyrone, acetaminophen|The dosage for the three drugs was the same: 10 milligrams per kilo, oral administration
16204519|NCT01359007|Drug|Irinotecan, Oxaliplatin, Leucovorin, 5-FU|5-FU 2400 mg/m2 IV continuous infusion for 46-48 hours Days 1-3 for 2 weeks 5-FU 400 mg/m2 IV Bolus Day 1 Oxaliplatin 85 mg/m2 IV over 120min +/-30 min. Day 1 Irinotecan 180 mg/m2 IV to run over 90 min +/- 30 min Day 1 Leucovorin (Before bolus 5-FU) 400 mg/m2 IV over 120 min. +/- 30 Day 1 May give oxaliplatin and leucovorin concurrently
16204520|NCT01358981|Drug|LY2881835|Administered orally
16204521|NCT01358981|Drug|Placebo|Administered orally
16204522|NCT01358968|Drug|LY2603618|Administered intravenously as a 1-hour infusion.
16204523|NCT01358968|Drug|Desipramine|Administered orally
16204524|NCT01358968|Drug|Pemetrexed|Administered intravenously as a 10-minute infusion.
16204525|NCT01358968|Drug|Gemcitabine|Administered intravenously as a 30-minute infusion.
16204526|NCT01358955|Other|group cognitive intervention|The cognitive training will be administered twice a week for 12 weeks, located in hospital-based outpatient memory clinics. Each session will last approximately 90 minutes. The cognitive training programs will be offered in group sessions consisted of 5 participants.
16204527|NCT01358955|Other|Home-based cognitive intervention|The participants will do their paper and pencil homework for 30 minutes every business days for 12 weeks.
16204528|NCT01358929|Drug|Placebo|Placebo to RO6807952
16204529|NCT01358929|Drug|RO6807952|Escalating subcutaneous dose
16204530|NCT01358916|Other|Mailing of antibiotic therapy guidelines to the sentinel physicians|Mailing of antibiotic therapy guidelines to the sentinel physicians and regular feedback on antibiotic prescription
16204531|NCT01358903|Drug|RO5429083|Cohorts receiving multiple escalating doses iv
16204532|NCT01358903|Drug|RO5429083|Cohorts receiving 89Zr-labelled RO5429083 plus RO5429083, followed by RO5429083 until disease progression
16204533|NCT01358890|Other|low carbohydrate diet|Dietary carbohydrate diet was restricted to 20 gram/day within the first week, then increase gradually to 120 gram/day
16204534|NCT01358890|Other|Calories restricted diet|Total energy intake is restricted to 1200 kcal/day for women. Energy from carbohydrate, protein and fat will be kept to approximate 55%, 20% and 25%, respectively. Moreover, saturated fat and dietary cholesterol are restricted to at most 10% energy and 300 mg/day, respectively
16204535|NCT01358877|Drug|5-Fluorouracil|5-Fluorouracil will be administered as per the schedule specified in the respective arm.
16204536|NCT01358877|Drug|Carboplatin|Carboplatin will be administered as per the schedule specified in the respective arm.
16204537|NCT01358877|Drug|Cyclophosphamide|Cyclophosphamide will be administered as per the schedule specified in the respective arm.
16204538|NCT01358877|Drug|Docetaxel|Docetaxel will be administered as per the schedule specified in the respective arm.
16204539|NCT01358877|Drug|Doxorubicin|Doxorubicin will be administered as per the schedule specified in the respective arm.
16204540|NCT01358877|Drug|Epirubicin|Epirubicin will be administered as per the schedule specified in the respective arm.
16204541|NCT01358877|Drug|Paclitaxel|Paclitaxel will be administered as per the schedule specified in the respective arm.
16204542|NCT01358877|Drug|Pertuzumab|Pertuzumab will be administered as per the schedule specified in the respective arm.
16204543|NCT01358877|Drug|Placebo|Placebo will be administered as per the schedule specified in the respective arm.
16204544|NCT01358877|Drug|Trastuzumab|Trastuzumab will be administered as per the schedule specified in the respective arm.
16204545|NCT01358864|Drug|BI 201335|BI 201335 once a day (QD) for 24 weeks
16204546|NCT01358864|Drug|Pegylated Interferon-alpha (IFN)|Pegylated Interferon-alpha for 48 weeks
16204547|NCT01358864|Drug|Ribavirin (RBV)|Ribavirin (RBV) for 24 or 48 weeks
16204548|NCT01358864|Drug|Placebo|Placebo to BI201335 for 24 weeks
16204549|NCT01358851|Procedure|Cryotherapy|1-2 times during the treatment time
16204550|NCT01358851|Drug|LAS41005|once daily
16204551|NCT01358838|Device|ablative 10600 nm fractional laser therapy|"Half of the scar, or one of two comparable scars, will be treated with the ablative 10600 nm fractional laser. There wil be 3 treatments, with 8 weeks apart.
~Half of the scar, or one of two comparable scars, will receive no treatment at all."
16204552|NCT01358825|Procedure|Blood Sampling|A blood sample will be taken at 5 years of age, after vaccination in the primary study.
16204553|NCT01358812|Drug|FOLFOXIRI + Panitumumab|PANITUMUMAB 6 mg/Kg i.v. over 1 hour followed by IRINOTECAN 150 mg/sqm i.v. over 1 hour followed by OXALIPLATIN 85 mg/sqm i.v. over 2 hours concomitantly with L-LV 200 mg/sqm over 2 hours followed by 5-FLUOROURACIL* 2400 mg/sqm c.i. over 48 hours starting on day 1 repeated every 2 weeks.
16204554|NCT01358799|Device|APTIMA Assay for Chlamydia trachomatis|APTIMA Assay for Chlamydia trachomatis
16204555|NCT01358786|Procedure|quilting suture|"quilting sutures and drains
~quilting sutures but no drains"
16204556|NCT01358773|Other|multidisciplinary intervention|Comparison of the polysomnography results, blood collection parameters, resting metabolic rate values, body composition variables, carotid artery thickness values, abdominal and subcutaneous fat and lung function variables baseline, middle and at the end of the one year of interdisciplinary weight loss program combined exercise training with physiotherapy, clinical, nutritional and psychological therapies.
16204557|NCT01358760|Drug|Placebo|Placebo vaginal suppository
16204558|NCT01358760|Drug|DHEA|Vaginal suppository containing 0.25% (3.25 mg) DHEA
16204559|NCT01358760|Drug|DHEA|Vaginal suppository containing 0.5% (6.5 mg) DHEA
16204560|NCT01358747|Drug|BEACOPPesc|
16204561|NCT01358747|Drug|BEACOPPesc - ABVD - PET2|
16204562|NCT01358734|Drug|Azacitidine|Azacitidine at 75 mg/m^2/day subcutaneous on Days 1-7
16204563|NCT01358734|Drug|Lenalidomide|Lenalidomide 50 mg PO daily x 28 days for the first 2 cycles then 25 mg PO daily x 28 days for the next 2 cycles followed by continuous 28-day cycles of lenalidomide 10 mg PO daily
16204564|NCT01358734|Other|Best Supportive Care (BSC)|"The use of BSC was considered as concomitant treatment and must be documented as concomitant medication.
~BSC includes, but is not limited to, treatment with Red Blood Celll (RBC) or whole blood transfusions, fresh frozen plasma transfusions, platelet transfusions, antibiotic or antifungal therapy, and nutritional support"
16204568|NCT01358708|Drug|LACTEOL® 340 mg|LACTEOL® 340 mg will be taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
16204569|NCT01358708|Drug|PLACEBO|Matched LACTEOL® 340 mg Placebo will be taken for a 4-week duration (28 days) as three capsules a day: two capsules in the morning and one capsule in the evening.
16204570|NCT01358695|Biological|ANT-1207|The interventions differ by dose of investigational product applied.
16204571|NCT01358695|Biological|Botulinum Toxin, Type A|The interventions differ by dose of investigational product applied.
16204572|NCT01358695|Biological|Botulinum Toxin Type A|The interventions differ by dose of investigational product applied.
16204573|NCT01358669|Drug|Denosumab|60mg denosumab by injection as a single dose
16204574|NCT01358669|Other|Placebo|Placebo by injection as a single dose
16204575|NCT01358656|Procedure|Single bundle anterior cruciate ligament reconstruction|The surgical technique includes ACL reconstruction with graft of two autologous tendons - the semitendinous and gracilis - fixed in one tibial tunnel and one femoral tunnel. Once the graft is obtained, the arthroscopy-assisted ACL reconstruction is performed using anterolateral, anteromedial and accessory anteromedial portals. The first tunnel to be built is femoral tunnel, through a Smith & Nephew femoral guide inserted into the anteromedial portal in the 10:30 h position for the right knee and 1:30 h position for the left knee, with the knee at 120° of flexion. The next tunnel is tibial tunnel. The tunnel has its point of entry anterior to the fibers of the superficial medial collateral ligament, and the tibial guide must be adjusted at 45 degrees. The new ligament is fixed onto the tibia and femur with a biodegradable interference screw.
16204576|NCT01358656|Procedure|Double bundle anterior cruciate ligament reconstruction|The ACL reconstruction is performed with graft of two autologous tendons -the semitendinous and gracilis- fixed in two tibial tunnels and two femoral tunnels. The first tunnel to be built is the anteromedial (AM) femoral tunnel, through femoral guide inserted into the AM portal in the 10:30 h position for the right knee and 1:30 h position for the left knee, with the knee at 120° of flexion. Then we drill the PL femoral tunnel in its anatomical position from the accessory AM portal, with the knee at 120° of flexion. The next tunnels are the PM and AM tunnels. The PL tunnel has its point of entry anterior to the fibers of the superficial medial collateral ligament, and the tibial guide must be adjusted at 45º. The AM tunnel has its point of entry more lateral, and a bone bridge of at least one cm must be left between the tunnels, and the tibial guide adjusted at 55º. Both bundles must be fixed onto the tibia and femur with a biodegradable interference screw.
16204577|NCT01358643|Other|Three home-based diet and exercise programs|"All research activities are outpatient. This pilot study will be a crossover study of two 6-week programs. The participant will be involved for 15 weeks.
~Thirty OEF/OIF veterans with BMI > 30 will be recruited to test the diet and exercise programs. Each veteran will test only two of the three programs described above. The participants will use the the programs for six weeks then crossover and use a second program."
16204578|NCT01358617|Other|diagnostic laboratory biomarker analysis|Correlative studies
16204579|NCT01358604|Genetic|polymerase chain reaction|
16204580|NCT01358604|Genetic|protein expression analysis|
16204581|NCT01358604|Genetic|western blotting|
16204582|NCT01358604|Other|flow cytometry|
16204583|NCT01358604|Other|immunohistochemistry staining method|
16204584|NCT01358604|Other|laboratory biomarker analysis|
16204585|NCT01358591|Dietary Supplement|High calcium milk|High calcium milk (9 mg/kgBM)
16204586|NCT01358591|Dietary Supplement|Control|Regular Milk
16204587|NCT01358578|Drug|Placebo|Placebo to Match secukinumab (AIN457) 150mg or 300mg or Placebo to match etanercept
16204588|NCT01358578|Drug|secukinumab (AIN457)|secukinumab (AIN457) 150mg or 300mg subcutaneous
16204589|NCT01358578|Drug|etanercept|etanercept 50mg subcutaneous
16204590|NCT01358565|Drug|Fx-1006A|A single oral 20 mg dose of Fx-1006A will be administered on Day 1 followed by 16 days of follow-up.
16204591|NCT01358565|Drug|Fx-1006A|A single oral 20 mg dose of Fx-1006A will be administered on Day 1 followed by 16 days of follow-up.
16204592|NCT01358552|Other|Néevo®/ NéevoDHA®|Néevo®/NéevoDHA® is an orally administered medical food indicated for the dietary management of impaired metabolic processes in women under a doctor's care who face high to intermediate risk pregnancies and are unable to fully metabolize or absorb folic acid. Néevo®/ NéevoDHA® contains L-methylfolate, the biologically active and immediately bioavailable form of folate.
16204593|NCT01358539|Behavioral|Pain education|Patients receiving pain education
16204594|NCT01358526|Drug|Oxycodone/Naloxone Controlled-release|Oxycodone/Naloxone Controlled-release tablets (10/5 mg, 20/10 mg, 30/15 mg, 40/20 mg) taken orally every 12 hours
16204595|NCT01358526|Drug|Placebo|Placebo tablets to match OXN taken orally every 12 hours
16204596|NCT01358500|Drug|Fentanyl|Intravenous infusion using STANPUMP
16204597|NCT01358487|Behavioral|Online self-help course plus live follow-up if needed|In addition to the self-help mood management course and the email reminders to return to the site to complete assessments at 1, 3, and 6 months (and the monetary incentives), this condition will also receive phone reminders if they do not complete assessments online.
16204598|NCT01358487|Behavioral|Online + incentives Follow-up Group|This group tests online email reminders and monetary online incentives to estimate percentage of participants who will complete online assessments at 1, 3, and 6 month follow-ups.
16204599|NCT01358461|Biological|Blood sampling|Blood sampling
16204600|NCT01358461|Other|ECG-Holter 24 h tape and sino-carotid stimulation test|ECG-Holter 24 h tape and sino-carotid stimulation test
16204601|NCT01358448|Behavioral|growth monitoring|Caretakers will be encouraged to monitor child growth monthly.
16204602|NCT01358448|Behavioral|Growth Monitoring plus Family-based Behavioral Counseling|Caretakers will monitor growth monthly in addition participating in family-based behavioral counseling
16204603|NCT01358435|Biological|30% Regular Insulin Human Neutral and 70%Isophane Insulin|Total Dose per subject is 0.4 IU/Kg given subcutaneously.
16204604|NCT01358435|Biological|Novolin 70/30|Total Dose per subject is 0.4IU/Kg given Subcutaneously.
16204605|NCT01358409|Drug|Nebivolol|Day 1 - Patients will start Nebivolol 5 mg PO daily; after one month, if the subject has tolerated 5 mg PO Nebivolol, the dose will be increased to 10 mg PO daily. If the patients is unable to tolerate 5 mg PO Nebivolol, he/she will be discontinued from the study. After six months, medication will be tapered to 5 mg PO daily for two weeks. Medication will then be tapered to 2.5 mg PO daily for two additional weeks.
16204606|NCT01358396|Other|Respond to therapy for diabetic macular edema|Correlate HBA1c with visual acuity outcome to therapy.
16204607|NCT01358383|Drug|naproxen|250mg, oral dose
16204608|NCT01358383|Drug|esomeprazole|20mg, oral dose
16204609|NCT01358357|Drug|Lurasidone|Lurasidone 20 mg daily (days 1-3), Lurasidone 40 mg daily (days 4-7), Lurasidone 20-80 mg daily (flexible dose) thereafter
16204610|NCT01358357|Drug|Placebo|20-80 mg flexible dose
16204611|NCT01358344|Drug|Pantoprazole|40 mg delayed-release tablet administered orally in the morning of Days 1-7
16204612|NCT01358344|Drug|SCH 530348 (high percentage)|2.5 mg tablet containing ~46% active pharmaceutical ingredient (API) as free base (46+5%) administered orally on the morning of Day 5
16204613|NCT01358344|Drug|SCH 530348 (standard percentage)|2.5 mg tablet containing ~23% API as free base (STANDARD) administered orally on the morning of Day 5
16204614|NCT01358331|Drug|MK-8353|Administered orally twice daily for 28 days for each cycle
16204615|NCT01358318|Other|Satiety|Single consumption of snack bars to determine satiety and food intake at next meal.
16204616|NCT01358305|Other|Protein Blend|Single intake of approximately 20 grams of total protein
16204617|NCT01358292|Procedure|Semi-extended Surgical Technique|Surgical technique with the knee in 10-20 degrees of flexion, to implant the intramedullary tibia nail.
16204618|NCT01358292|Procedure|Standard Surgical Technique|Th e Standard surgical techique is implanting the tibia nail with the knee in 90 degrees of flexion.
16204619|NCT01358279|Procedure|transcranial direct current stimulation|A constant current of 2 mA intensity applied for 20 min over C3 or C4
16204620|NCT01358266|Drug|DE-109 44 ug|Low dose
16204621|NCT01358266|Drug|DE-109 440 ug|Medium dose
16204622|NCT01358266|Drug|DE-109 880 ug|High dose
16204623|NCT01358253|Drug|Cyclophosphamide|300 mg/m2 IV over 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2)(odd courses).
16204624|NCT01358253|Drug|Doxorubicin|50 mg/m2 IV over 2-24 hours via CVC on day 4 after last dose of cyclophosphamide given (odd courses).
16204625|NCT01358253|Drug|Vincristine|Consolidation:1.4 mg/m2 (max 2mg) IV on day 4 and day 11 (odd courses). Maintenance:1.4mg/m2(max 2mg) IV monthly from 1st to 12th month.
16204626|NCT01358253|Drug|Dexamethasone|40mg IV or by mouth (P.O.) daily days 1-4 and days 11-14(odd courses)
16204627|NCT01358253|Drug|Cytarabine|2g/m2 IV over 2 hours every 12 hours for 4 doses on days 2, 3 (even courses).
16204628|NCT01358253|Drug|Methotrexate|Consolidation:1000 mg/m2 IV over 24 hours on day 1 (even courses). Maintenance:25mg/m2 weekly for 24 months.
16204629|NCT01358253|Drug|Rituximab|"Consolidation:375 mg/m2 IV day 1 for the odd courses of therapy (total 4 times).
~Maintenance:375 mg/m2 IV in 6th month and 12th month."
16204630|NCT01358253|Drug|6-Mercaptopurine|Maintenance:60mg/m2 daily for 24 months.
16204631|NCT01358253|Drug|Prednisone|Maintenance:40mg/m2 from days 1-7 monthly from 1st to 12th month.
16204632|NCT01358253|Drug|L-asparaginase|Maintenance:6000IU/m2 IV on days 1,3,5 of the 3rd and 9th month.
16204633|NCT01358240|Drug|Econazole Nitrate Foam 1%|Econazole Nitrate Foam 1% applied once a day for 4 weeks
16204634|NCT01358240|Drug|Vehicle Foam|Vehicle Foam applied once a day for 4 week
16204635|NCT01358240|Drug|Econazole Nitrate Cream 1%|Econazole Nitrate Foam 1% applied once a day for 4 weeks
16204636|NCT01358240|Other|Placebo Cream|Placebo cream applied once a day for 4 weeks
16204637|NCT01358227|Drug|PR104|Dose escalation of PR104 to determine maximum tolerated dose for weekly administration
16204638|NCT01358214|Behavioral|Questionnaire on Quality of Life.|The impact of a disease on patient's Quality of Life has meanwhile gained more influences on the choice of treatment alternatives. The benefit of a method is currently not only defined by the objective outcome but also influenced by the Quality of Life. Two questionnaires with 20 respectively 40 Questions should be filled in by the patients.
16204639|NCT01358201|Drug|vINCRISTINE|
16204640|NCT01358201|Drug|Dexamethasone|
16204641|NCT01358201|Drug|Methotrexate|
16204642|NCT01358201|Drug|Cytosine arabinoside|
16204643|NCT01358175|Drug|Secukinumab (75 mg)|Secukinumab (75 mg)
16204644|NCT01358175|Drug|Secukinumab (150 mg)|Secukinumab (150 mg)
16204645|NCT01358175|Drug|Placebo|Placebo
16204646|NCT01358162|Other|Placebo|Placebo given orally, daily for 14 consecutive days
16204647|NCT01358162|Drug|SQ109|A single oral dose of 300 mg of SQ109 given daily for 14 consecutive days.
16204648|NCT01358149|Other|cocoa-based food|single intake of cocoa-based food
16204649|NCT01358149|Other|cocoa-based food|Single intake of cocoa-based food
16204650|NCT01358110|Other|Early palliative care consultation|Patients will have symptoms assessed, have goals of care discussion with family and team present, and surrogate designated, as well as coordination of care and home services.
16204651|NCT01358110|Other|Care as usual|Standard care as usual which may or may not include palliative care consultation
16204652|NCT01358084|Drug|NGR-hTNF|NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs
16204653|NCT01358084|Drug|Placebo|Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs
16204654|NCT01358084|Other|Best Supportive Care|Where applicable and as appropriate according to Institutional clinical practice and literature guidelines. Best supportive care includes antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
16204655|NCT01358071|Drug|NGR-hTNF|NGR-hTNF: 0.8 mcg/m² as 60 minutes intravenous infusion weekly or every 3 or 4 weeks until confirmed evidence of disease progression or unacceptable toxicity occurs
16204871|NCT01356290|Drug|Celecoxib|50-400mg, oral bid, daily, 1 year
16204656|NCT01358071|Drug|Pegylated liposomal doxorubicin|50 mg/m² iv every 4 weeks until confirmed evidence of disease progression
16204657|NCT01358071|Drug|Doxorubicin|60 mg/m² iv every 3 weeks for a maximum of 8 cycles
16204658|NCT01358058|Radiation|Proton radiation|Total dose of 54-59.4 Gy(RBE) at 1.8 Gy(RBE) per daily fraction delivered 5 days per week on weekdays for 6-6.5 weeks.
16204659|NCT01358045|Drug|Diclofenac|Application on the lesion 2 times a day 8 weeks.
16204660|NCT01358045|Drug|Diclofenac + Calcitriol|Application on the lesion 2 times a day, both ointments, 8 weeks.
16204661|NCT01358045|Drug|Calcitriol|Application on the lesion, 2 times a day, 8 weeks.
16204662|NCT01358032|Behavioral|an in-home cognitive behavioral program|The in-home cognitive behavioral program aims to learn older persons, living in the community, how to deal with concerns about falling and to increase physical, social and functional activity. The principles of cognitive restructuring are used for shifting maladaptive in adaptive attitudes with respect to falling as well as increasing self efficacy beliefs and feelings of control. The following themes are discussed during the program: concerns about falling, thoughts about falling, physical exercise, assert oneself, overcome personal barriers, recognizing fall-ty habits and managing concerns about falling. Duration of the program is 10 weeks with 7 individual sessions (3 home visits (60, 60 and 75 minutes, respectively) & 4 telephone contacts (35 minutes each). The program is facilitated by trained nurses qualified in the field of geriatrics and working for home care agencies.
16204663|NCT01358019|Drug|LY2523355|Days 1, 2, and 3 in a cycle that consists of 21-days
16204664|NCT01358006|Drug|JNJ-40411813|Cohort 1: Type=2 to 3, unit=mg, number=200 to 300, form=capsule, route=oral use.Capsule(s) taken in the fed state Capsule(s) taken in the fed state.
16204665|NCT01358006|Drug|JNJ-40411813|Cohort 2: Type=up to 7, unit=mg, number=up to 700 mg, form=capsule, route=oral use. Capsule(s) taken in the fed state.
16204666|NCT01357993|Drug|JNS001|18 mg, 27 mg and 36 mg tablets (18-72 mg/day) once daily for 48 weeks
16204667|NCT01357980|Biological|Botulinum toxin type A|750 U intra detrusor injection on Day 1 (single dose)
16204668|NCT01357980|Drug|Placebo|Intra detrusor injection on Day 1 (single dose)
16204669|NCT01357967|Drug|SSRI monotherapy|SSRI (paxil CR, es-citalopram, fluoxetine, sertraline) start with (paxil CR 12.5mg, es-citalopram 10mg, fluoxetine 20mg, sertraline 50mg) for 1 week up to maximal dosage, flexible dosage, usually in the morning
16204670|NCT01357967|Drug|Seroquel XR adjunctive|"Quetiapine group:
~seroquel XR 50mg Day 1 --> 50mg Day 2 --> 150mg Day 3 --> 150mg Day 4 --> adjustment usually at hs but can be daytime"
16204671|NCT01357954|Other|Regular physiotherapy|The child's regular physiotherapy
16204672|NCT01357954|Other|Targeted Training|Targeted training, 5 days a week for 6 months, up to 30 minutes a day
16204673|NCT01357915|Procedure|Blood sampling|"Blood samples will be collected at 2 time points:
~At the long-term follow-up at approximately Month 48 of study (= ± 42 months post dose 3) from all subjects in the vaccine group.
~At the long-term follow-up at approximately Month 60 of study (= ± 54 months post dose 3) from all subjects."
16204674|NCT01357915|Biological|GSK149203A|GSK Biologicals' Recombinant CMV glycoprotein B Vaccine, Intramuscular injection, 3 doses
16204675|NCT01357902|Drug|Lamotrigine|Lamotrigine is a selective inhibitor of a voltage-sensitive sodium channel, is an anti-epileptic drug of the phenyltriazine class.
16204676|NCT01357889|Biological|albiglutide (GSK716155)|subcutaneous injection administered once a week
16204677|NCT01357889|Biological|albiglutide (GSK716155)|subcutaneous injection administered once a week
16204678|NCT01357876|Other|Metformin|withdrawral
16204679|NCT01357863|Drug|Treatment|Patients treated with Lapatinib-capecitabine after Trastuzumab progression
16204680|NCT01357850|Drug|GSK716155|GSK716155
16204681|NCT01357850|Drug|Placebo|Placebo
16204682|NCT01357837|Drug|Matching Placebo|2 capsules of matching placebo once a day, in the morning, for a total of 28 days
16204683|NCT01357837|Drug|GRT6005|2 capsules containing a total of 75 µg GRT6005 once a day, in the morning, for a total of 28 days
16204684|NCT01357837|Drug|GRT6005|2 capsules containing a total of 200 µg GRT6005 once a day, in the morning, for a total of 28 days
16204685|NCT01357837|Drug|GRT6005|2 capsules containing a total of 400 µg GRT6005 once a day, in the morning, for a total of 28 days
16204686|NCT01357824|Procedure|Application of Sellick´s maneuver.|The patient will be intubated with a flexible fiberscope, Olympus model, under the application of Sellick´s maneuver, with the recommended 30 Newtons pressure, and also, as control, be intubated with a sham Sellick´s maneuver, with 0 Newton. The order of the pressures is randomized, and it is blinded to the intubating physician by a cloth which of the maneuvers that is used. The pressure is measured be a pediatric cuff, which is pressed against the throat.
16204687|NCT01357811|Drug|eliglustat; digoxin|repeat oral doses of 150 mg BID (or 100 mg BID if a CYP2D6 poor metabolizer) eliglustat (Day 11 to Day 17) plus singe dose of digoxin 0.25mg on Day 15
16204688|NCT01357811|Drug|digoxin|oral 0.25mg dose of digoxin (single dose) on Day 1
16204689|NCT01357798|Drug|Botulinum toxin type A|Botulinum Toxin group Will have the syringe with Botulinum toxin type A . During the study the patients will be following in the headache's clinic where the evaluator will graduate the pathologies' evolution.
16204690|NCT01357798|Drug|0,9% saline|0,9% saline group Will have the syringe with 0,9% saline. During the study the patients will be following in the headache's clinic where the evaluator will graduate the pathologies' evolution .
16204691|NCT01357785|Procedure|Cell therapy|The use of periodontal ligament stem cells for periodontal regeneration
16204692|NCT01357772|Drug|Tamoxifen|at daily dose of 5 mg for a total treatment time of 3 years
16204693|NCT01357772|Drug|placebo|placebo at daily dose of 5 mg for a total treatment time of 3 years
16204694|NCT01357759|Drug|MORAb-022|IV infusion of MORAb-022 at increasing doses starting with the minimal anticipated biological effect level (MABEL) which is 0.0085mg/kg.; IV infusion of Placebo (saline)
16204695|NCT01357759|Drug|MORAb-022|IV infusion of MORAb-022 at increasing doses starting with the minimal anticipated biological effect level (MABEL) which is 0.0085mg/kg.; IV infusion of Placebo (saline)
16204696|NCT01357746|Procedure|Transthoracic pulmonary doppler recording|A 30 min recording of doppler signals from the right chest wall including measurements while the patient performs Valsalva maneuvers
16204730|NCT01357447|Drug|Saline|2.5 ml via nebuliser BID for 2 weeks (alternating with study drug)
16204697|NCT01357733|Other|Early interim FDG PET/CT after 1 cycle of R-CHOP|FDG PET/CT imaging study obtained after 1 cycle of R-CHOP and before the second cycle of R-CHOP
16204698|NCT01357720|Biological|Quinvaxem|"A single dose (0.5 mL) of Quinvaxem contains:
~diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), whole-cell inactive pertussis bacteria (>= 4 IU), 10 mcg Hib oligosaccharide conjugate (approx. 25 mcg CRM197), 10 mcg Hepatitis B surface antigen
~One dose of Quinvaxem given at Weeks 6, 10 and 14"
16204699|NCT01357720|Biological|Quinvaxem/Tritanrix|"A single dose (0.5 mL) of Quinvaxem contains:
~diphtheria antitoxin (>= 30 IU), tetanus antitoxin (>= 60 IU), inactive pertussis bacteria (>= 4 IU), 10 mcg Hib polysaccharide conjugate (approx. 25 mcg tetanus toxoid), 10 mcg Hepatitis B surface antigen
~One dose of Quinvaxem given at Weeks 6, 10 and 14"
16204700|NCT01357707|Genetic|DNA preparation|Taking blood or saliva from the patient to prepare DNA therefrom
16204701|NCT01357694|Behavioral|psychotherapeutic contacts|psychotherapeutic contacts during inpatient hospital stay and up to 3 months outpatient appointments after discharge
16204702|NCT01357681|Drug|(2)-epigallocatechin-3-gallate (EGCG)|Month 01:400 mg /day (200-0-200) Month 02:800 mg /day (400-0-400) Month 03 -12: 1200 mg /day (600-0-600)
16204703|NCT01357681|Drug|Placebo|Placebo
16204704|NCT01357655|Drug|Dasatinib|Tablets, Oral, 100 mg, Once daily, approximately 5 years depending on response
16204705|NCT01357655|Drug|BMS-833923|Capsules, Oral, dose to be determined, Once daily, approximately 2 years depending on response
16204706|NCT01357642|Drug|Epinephrine inhalation aerosol|Epinephrine inhalation aerosol, 125 mcg/inhalation, 2 inhalations QID at 4 - 6 hour intervals
16204707|NCT01357642|Drug|Placebo|Placebo for epinephrine inhalation aerosol, formulation without epinephrine
16204708|NCT01357642|Drug|epinephrine inhalation aerosol|epinephrine inhalation aerosol, 220 mcg/inhalation, 2 inhalations QID at 4-6 hour intervals
16204709|NCT01357616|Drug|Brinzolamide 1% / Timolol 0.5% fixed combination ophthalmic suspension|
16204710|NCT01357616|Drug|Brinzolamide 1% ophthalmic suspension|
16204711|NCT01357616|Drug|Timolol 0.5% ophthalmic solution|
16204712|NCT01357603|Biological|Glargine|dosage form: Subcutaneous injection
16204713|NCT01357590|Device|Thoracic Endovascular Stent Graft System (ThoraflexTM)|Thoracic Endovascular Stent Graft System
16204714|NCT01357577|Behavioral|Cognitive behavioral therapy for PTSD|The CBT for PTSD model is based on modern theories of posttraumatic reactions that place a premium on the importance of individuals' appraisals of traumatic events, their own reactions and those of others, and the meaning of the experience in terms of oneself and one's place in the world. In addition, the model employs cognitive restructuring to teach individuals how to examine and challenge their trauma-related appraisals.
16204715|NCT01357564|Other|Tailored Activity Program|The interventionist, an occupational therapist, meets with the caregiver and introduces the intervention goals. The OT provides and reviews written educational materials about dementia, importance of taking care of self, communication strategies and other educational materials. Also provided and reviewed is The 36 Hour Day. The OT interviews the caregiver to obtain information about previous roles, habits, past and current daily routines, caregiver and Veteran preferences and interests. The OT also observes interactions, noting communication and management style. The OT will also meet with the Veteran, observe social capacity using the Peavy Comportment scale and administer the Dementia Rating Scale.
16204716|NCT01357564|Other|Attention Control|Caregivers in this group received bi-weekly telephone contact by a trained healthcare professional. In each session, caregivers were provided information about dementia and strategies for disease management. Each telephone contact began with a brief overview the session purpose, followed by a description of key facts, and concluded with a question and answer period. The attention control group intervention was delivered by a member of the research team who is knowledgeable about dementia and has had prior experience working with family caregivers.
16204717|NCT01357551|Behavioral|Maintenance intervention|Theoretically-informed maintenance intervention that involves in-person group visits that transition to individualized telephone calls, and the frequency of contact gradually decreases over time.
16204718|NCT01357538|Drug|Posiformin 2 %, bibrocathol|A strip of 5 mm eye ointment applied 3 times per day to the eye lid
16204719|NCT01357538|Drug|Placebo Comparator|corresponding vehicle, eye ointment applied to the eye lid
16204720|NCT01357525|Radiation|Stereotactic Body Radiation Therapy (SBRT)|"An SBRT plan will be created by a medical physicist based on the PTV contoured on the CT scan. The plan will be to deliver fractionated SBRT to the isodose line best encompassing the PTV:
~12 Gy x 3 fractions (36 Gy total)"
16204721|NCT01357512|Device|magnetic resonance imaging, Siemens|Magnetic resonance imaging (MRI) of prostate with Siemens 3-tesla device
16204722|NCT01357499|Device|blood pressure cuff|A Blood pressure cuff and and the muscle stimulator pads will be applied to one lower leg. The blood pressure cuff will be inflated with 200 mmHg for 5 minutes. Next reperfusion will be allowed for 5 minutes. This cycle will be repeated for 3 times.
16204723|NCT01357499|Device|blood pressure cuff + electric muscle stimulator|A Blood pressure cuff and and the muscle stimulator pads will be applied to one lower leg. The blood pressure Cuff will be inflated with 200 mmHg for 5 minutes. Next reperfusion will be allowed for 5 minutes. This cycle will be repeated for 3 times. In addition electrical muscle stimulation will be performed throughout the whole preconditioning cycle.
16204724|NCT01357486|Drug|sorafenib|patients receiving sorafenib 400 mg - twice a day
16204725|NCT01357486|Drug|Pravastatin|patients receiving pravastatin 40 mg - once a day
16204726|NCT01357486|Drug|Sorafenib + Pravastatin|patients receiving sorafenib 400 mg (twice a day) and pravastatin 40 mg (once a day)
16204727|NCT01357486|Other|patients receiving best supportive care|palliative management
16204728|NCT01357460|Device|Implantation of intrabronchial valves (IBV) (Spiration IBV)|"In advanced emphysema due to alpha1 antitrypsin deficiency even optimum treatment including drugs, physical training and possibly oxygen therapy is unable to influence exercise dyspnoea and exercise capacity.Implantation of intrabronchial valves in the most destroyed and hyperinflated lung lobe can improve the elastic recoil of the small airways by a reduction in lung volume and thus leading to more ergonomic breathing mechanics and diaphragm function.The one-way mechanism of these valves allows air to escape from the downstream lung segment without any influx of new air during inspiration."
16204729|NCT01357447|Drug|Dornase alfa|Dose: 2.5 mg solution BID via nebuliser for 2 weeks
16204872|NCT01356290|Drug|Fenofibric acid|90mg/m2, oral, daily, 1 year
16204731|NCT01357434|Behavioral|Fast Food Restaurant|Participants will purchase a meal at Subway and McDonald's, on different days.
16204732|NCT01357421|Drug|TT301|Single iv dose of TT301
16204733|NCT01357421|Drug|Placebo|Single iv dose of 0.9% sodium chloride for injection USP
16204734|NCT01357395|Drug|Amuvatinib|Amuvatinib 300 mg PO TID
16204735|NCT01357382|Other|Low carbohydrate diet|restrict carbohydrate consumption to < 20 grams / day while not restricting their caloric intake. Participants will be encouraged to consume vegetables with low carbohydrate content every day including 2 cups of salad greens and 1 cup of vegetables 'that grow above the ground' increase their salt intake by consuming two cups of broth , ½ teaspoon of salt, or tablespoons of salt daily
16204736|NCT01357369|Procedure|Phlebotomy|Blood samples will be drawn from the mother, umbilical vein and artery post delivery, and neonate with other clinical labs.
16204737|NCT01357356|Drug|SER120 (750 ng/day)|
16204738|NCT01357356|Drug|SER120 (1000 ng/day)|SER120 (1000 ng/day)
16204739|NCT01357356|Drug|SER120 (1500 ng/day)|
16204740|NCT01357356|Drug|Placebo|
16204741|NCT01357343|Other|Chiropractic|Spinal manipulation and active and passive therapy.
16204742|NCT01357343|Other|Acupuncture|Acupuncture needling, moxa, Tui Na and cupping.
16204743|NCT01357330|Drug|SAR245408 (XL147)|Pharmaceutical form:capsule and tablet Route of administration: oral
16204744|NCT01357330|Drug|MSC1936369B|Pharmaceutical form:capsule Route of administration: oral
16204745|NCT01357317|Other|Diet counseling|If serum phosphorus level exceeds 4.6 mg/dl in the lanthanum carbonate arm in spite of consecutive up-titration of the medical dose or due to patients' intolerance of the medication, patient will be considered a treatment failure and other treatment options will be implemented, including diet counseling or another class of phosphorus binder (in this order of preference).
16204746|NCT01357317|Other|Diet counseling|If serum phosphorus level exceeds 4.6 mg/dl in spite of consecutive up-titration of the medication dose or due to patients' intolerance of the medication, patient will be considered a treatment failure and other treatment options will be implemented, including diet counseling or another class of phosphorus binder (in this order of preference).
16204747|NCT01357317|Drug|Phosphorus binder|If serum phosphorus level exceeds 4.6 mg/dl after 3 months of concerted efforts, the patient will be considered a treatment failure and treatment with a phosphorus binder of the treating physician's choice will be allowed.
16204748|NCT01357304|Behavioral|Group treatment and PAR|Group treatment (8-12 patients per group) involving an empowerment-based process and the 5-A model and including PAR. Two group sessions, 6 months apart. The estimated total time for both group sessions together is 100 minutes.
16204749|NCT01357291|Behavioral|Recidivism Reduction Program|Assigned to the 21-module Recidivism Reduction Program
16204750|NCT01357291|Behavioral|Business-as-usual|Inmates who receive standard programming offered by New Mexico Department of Corrections prior to release.
16204751|NCT01357278|Procedure|Rehabilitation and patient education|"Supervised rehabilitation consists of exercises for strength, balance and coordination twice weekly, and a home-training programme once weekly.
~Patient education will be offered every eight week."
16204752|NCT01357265|Biological|Seasonal Influenza Vaccine|This phase II is performed as a multicenter study in adult and elderly subjects. Enrolled subjects received one single IM dose of trivalent subunit inactivated flu vaccine during the vaccination visit, according to the study protocol (follow-up period: until day 22) .
16204753|NCT01357252|Drug|vildagliptin|
16204754|NCT01357252|Drug|Placebo|
16204755|NCT01357239|Drug|AFQ056|
16204756|NCT01357239|Drug|Placebo|
16204757|NCT01357213|Drug|XOMA 3AB|Single intravenous infusion of XOMA 3AB in three cohorts at different concentrations.
16204758|NCT01357213|Other|Placebo|Normal saline 100 ml
16204759|NCT01357200|Other|enteral formula|Complete feeding of study enteral formula, route and regime prescribed by the physician.
16204760|NCT01357187|Other|Scheduled removal of posterior instrumentation with AmnioFix|
16204761|NCT01357187|Other|Scheduled removal of posterior instrumentation without AmnioFix|
16204762|NCT01357161|Drug|MK-1775|MK-1775 capsules, orally, twice a day (BID) for a total of 5 doses starting on Day 1 of each 3-week cycle
16204763|NCT01357161|Drug|Placebo|placebo to MK-1775, capsule, orally, BID for a total of 5 doses, starting on Day 1 of each 3-week cycle
16204764|NCT01357161|Drug|paclitaxel|paclitaxel, intravenous (IV) infusion on Day 1 of each 3-week cycle
16204765|NCT01357161|Drug|carboplatin|carboplatin, IV infusion on Day 1 of each 3-week cycle
16204766|NCT01357148|Drug|Sitagliptin Phosphate/Metformin HCl (JANUMET®)|Participants prescribed Sitagliptin Phosphate/Metformin HCl (JANUMET®) in routine clinical practice.
16204767|NCT01357135|Drug|Metformin|
16204768|NCT01357135|Drug|Sitagliptin|
16204769|NCT01357135|Drug|Sulfonylurea|
16204770|NCT01357135|Drug|Antihyperglycemic Medication|
16204771|NCT01357122|Device|NCI Insertion|DSAEK surgery will be performed using the NCI to insert the donor tissue.
16204772|NCT01357122|Procedure|Standard Forceps Insertion|DSAEK surgery will be performed using forceps to insert the donor tissue. This is our long-established technique for DSAEK, with well-documented excellent results.
16204773|NCT01357109|Drug|Bosentan|62.5 mg bid for two weeks and 125 mg bid for two weeks
16204774|NCT01357109|Drug|Placebo|Matched placebo bid
16204775|NCT01357096|Behavioral|Integrated health care team|CAD education fryers, drugs counseling, diet intervention, individualized exercise program, body weight control, smoking cessation program, and distant CAD care monitoring
16204776|NCT01357096|Other|Traditional group|CAD education fryers
16204777|NCT01357070|Dietary Supplement|Brocco-sprout homogenate|Participants will be asked to orally consume on three consecutive days a brocco-sprout homogenate (70g dry weight).
16204778|NCT01357070|Dietary Supplement|Alfalfa sprout homogenate|Participants will be asked to orally consume on three consecutive days an alfalfa sprout homogenate.
16204779|NCT01357044|Dietary Supplement|Extracts of Punica granatum and Alpinia galanga|Tablets, two in the morning and two in the evening
16204780|NCT01357044|Dietary Supplement|Placebo|Tablets, two in the morning and two in the evening
16204825|NCT01356680|Drug|BEACOPPescalated (Bleomycin, Etoposide, Adriamycin, Cyclophosphamide, Vincristine, Procarbazine, Prednisone)|
16204781|NCT01357031|Drug|Amitriptyline|It will be administered Amitriptyline (25mg) once a day at bed time. Patients may keep their abortive treatment that they usually used. The drug will be encapsulated in a bottle of 30 capsules will be given to patients at every visit.
16204782|NCT01357031|Drug|Melatonin|It will be administered Melatonin (3mg) at bed time, half an hour before the usual time of sleep of the patient.
16204783|NCT01357031|Drug|Placebo|It will be administered placebo capsules, identical to Melatonin (3mg) and Amitriptyline (25 mg) patients will take the study medication at bed time
16204784|NCT01357005|Other|No intervention would be provided in this research|No intervention would be provided in this research, but need to draw blood
16204785|NCT01356992|Drug|Enoxaparin|Drugs will be provided by the sponsor to the study's patients on the reference presentation: 40 mg/0.4mL, 60 mg/0.6 mL and 80 mg/0.8 mL (solution for injection of enoxaparin sodium, 1 mg/ kg Sanofi-Aventis) or Eurofarma enoxaparin sodium (1 mg/ kg). The patients will use the drug corresponding to the arm of the study to which they were allocated. The drug administration must be performed through subcutaneous via on the dose of 1 mg/kg every 12 hours for at least 2 days and kept until the patient is discharged.
16204786|NCT01356979|Procedure|Medical thoracoscopy|Performing medical thoracoscopy to diagnose pleural diseases after cytological and other investigational tests.
16204787|NCT01356966|Drug|Tetrahydrobiopterin|Tetrahydrobiopterin (BH4) 200 mg PO BID for 12 weeks
16204788|NCT01356966|Drug|Placebo|2 placebo pills PO BID for12 weeks
16204789|NCT01356966|Dietary Supplement|Folate|Folate 1 mg daily for 12 weeks
16204790|NCT01356953|Other|Aerobic exercise|Intensity of aerobic exercise
16204791|NCT01356940|Drug|dalfampridine ER|dalfampridine ER 10mg bid for 4 weeks
16204792|NCT01356940|Drug|placebo|identical placebo tablet administered bid for four weeks
16204793|NCT01356927|Drug|DMPA|DMPA 150 mg IM given on the day of mifepristone 200 mg po for medical abortion
16204794|NCT01356927|Drug|Etonogestrel implant|Etonogestrel implant placed at the time of mifepristone 200 mg po for medical abortion
16204795|NCT01356914|Drug|BMS-914392|Tablets, Oral, 10 mg, Every Day (QD), 20 days
16204796|NCT01356914|Drug|BMS-914392|Tablets, Oral, 10 mg, Three Times Daily (TID), 20 days
16204797|NCT01356914|Drug|BMS-914392|Tablets, Oral, 20 mg, Three Times Daily (TID), 20 days
16204798|NCT01356914|Drug|Placebo|Tablets, Oral, 0 mg, Three Times Daily (TID), 20 days
16204799|NCT01356888|Device|Percutaneous Coronary Intervention (Abbott Laboratories - Xience Prime DES)|Stenting
16204800|NCT01356888|Device|Percutaneous Coronary Intervention (Orsiro DES)|stenting
16204801|NCT01356875|Drug|BSC|The support group will be receive transfusional BSC, erythropoietin and / or G-CSF as determined by the physician.
16204802|NCT01356875|Drug|HIDRA/VPA|In each cycle (30 days), Hydralazine 50mg tablets every 12 hours and Valproic 500mg tablets every 8 hours will be administrated orally to HYDRA / VPA group.Each patient will receive 6 cycle.
16204803|NCT01356862|Drug|PASIREOTIDE|One INTRAMUSCULAR INECTION OF PASIREOTIDE 60 MG 10 TO 7 DAYS BEFORE SURGERY
16204804|NCT01356862|Drug|PLACEBO|ONE INJECTION OF PLACEBO 10 TO 7 DAYS BEFORE SURGERY
16204805|NCT01356849|Drug|Atrasentan|Subjects will take two tablets daily of either low dose Atrasentan QD or high dose Atrasentan QD for 12 weeks during the treatment period.
16204806|NCT01356849|Drug|Placebo|Subjects will take two tablets daily of placebo QD for 12 weeks during the treatment period.
16204807|NCT01356823|Biological|30μg HPV|Participants would intramuscularly receive 30μg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.
16204808|NCT01356823|Biological|60μg HPV|Participants would intramuscularly receive 60μg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.
16204809|NCT01356823|Biological|90μg HPV|Participants would receive 90μg HPV vaccines which contains 60μg HPV 16 antigen and 30μg HPV 18 antigen
16204810|NCT01356823|Biological|Hepatitis B vaccine|Participants would intramuscularly receive 10μg of hepatitis B vaccine at 0, 1, 6 month for 3 doses.
16204811|NCT01356810|Other|Environmental Intervention|The environmental intervention consisted of daily reorientation, avoidance of sensorial deprivation, longer visiting hours, the availability of a clock, a calendar and the presence of familiar objects in the room.
16204812|NCT01356810|Other|Standard Care|Delirium management by the attending physician's preferences.
16204813|NCT01356797|Drug|hypobaric levobupivacaine with fentanyl|SSSA with 4 mg hypobaric levobupivacaine 0,13% with 10 mcg fentanyl
16204814|NCT01356797|Drug|hyperbaric bupivacaine 0,5%|SUSA with 4 mg hyperbaric bupivacaine 0.5%
16204815|NCT01356784|Other|Tailored Physical Activity|Health counselling (1,5h) and graded physical activity (3×50 min/week in 10 weeks)
16204816|NCT01356784|Behavioral|"Chronic Pain Self-management Programme"|Health counselling (1,5h) and 'Chronic Pain Self-management Program' (2,5h in 6 weeks)
16204817|NCT01356784|Behavioral|Health counselling|Health guidance (1,5h)
16204818|NCT01356771|Other|Surveys & Mailed Materials|"Phase I: Patients are screened for their level of risk for skin cancer. They will complete a survey and undergo a skin exam administered by the research staff. Moderate- and high-risk persons will be invited to enroll in Phase II.
~Phase II: Three sets of materials will be sent in the mail over the course of 6 weeks. Pamphlets will contain information about ways to reduce participant's risk of skin cancer, including sun protection practices, benefits of skin screening practices, and how to do skin self-examinations.
~The participant will also complete two surveys for this study, one at baseline and then one at follow up approximately three months later.
~Each survey will ask the participant about:
~Current and past skin cancer screening practices
~Current and past sun protection practices
~Attitudes about skin cancer and sun protection
~Knowledge of melanoma"
16204819|NCT01356758|Drug|biological treatment|patients treated with anti-psoriatic biological agents
16204820|NCT01356745|Drug|Premixed 50% nitrous oxide and oxygen (Kalinox)|15 min inhalation dose (maximum duration of treatment of a subject)
16204821|NCT01356745|Drug|medical air|inhalation gas for inhalation use
16204822|NCT01356732|Drug|Sufentanil|From 0 to 0,05 µg/kg to a maximum of 4 µg/kg of sufentanil. 7 minutes before nursing 3 nursing per day during 3 days
16204823|NCT01356693|Drug|Bromelin|Ananas comosus extract (3,3g) on vehicle: methylparaben, propylparaben, honey from Apis mellifera, sodium benzoate, ethilic alcohol, water) 5ml. Given in single dose.
16204824|NCT01356693|Drug|Placebo|Placebo with mimicking characteristics of experimental drug
16204826|NCT01356680|Drug|ABVD (Adriamycin, Bleomycin, Vinblastine, Dacarbazine)|
16204827|NCT01356680|Radiation|30Gy IF-RT (Involved-Field Radiotherapy)|
16204828|NCT01356680|Radiation|30Gy IN-RT (Involved-Node Radiotherapy)|
16204829|NCT01356667|Behavioral|DARTNA|3-hour protocol provided 2x/week over 12 weeks
16204830|NCT01356667|Behavioral|Treatment-As-Usual|Participants will receive typical substance abuse behavior treatment interventions typically provided to patients including individual counseling, group therapy, and standard culturally-based interventions.
16204831|NCT01356654|Device|Application of Transcranial direct current stimulation (TDCS)|Application of TDCS for 20 minutes, 4 times a week for 4 weeks.
16204832|NCT01356654|Device|Transcranial Direct current stimulation|Application of true TDCS for 20min, 4 times a week for 4 weeks.
16204833|NCT01356641|Drug|Antibiotic treatment alone|Amoxicillin/clavulanic acid 100/10 mg/kg 6-hourly Gentamicin 7 mg/kg once daily At least 48 hours intravenous administration, in total seven days of antibiotics Oral amoxicillin/clavulanic acid 50/12.5mg/kg
16204834|NCT01356641|Procedure|Appendectomy|Appendectomy either open or laparoscopic depending on the surgeon's preference
16204836|NCT01356615|Drug|low molecular weight heparin (enoxaparin sodium)|Enoxaparin sodium (Clexane; 40 mg) was administered 3-4 min before dialysis as a bolus dose, into the arterial line pre-dialyzer.
16204837|NCT01356615|Drug|standard unfractionated heparin|Heparin (sodium heparin 5000 IU/ml) was administered as a bolus dose (50 IU/kg body weight) intravenously into the pre-dialyzer arterial line of the extracorporeal blood circuit, followed by a maintenance dose of 1000 IU sodium heparin per hour.
16204838|NCT01356602|Drug|Canakinumab pre-filled syringe|Canakinumab pre-filled syringe
16204839|NCT01356602|Drug|Canakinumab lyophilized powder|Canakinumab lyophilized powder
16204840|NCT01356602|Drug|Triamcinolone Acetonide|Triamcinolone Acetonide
16204841|NCT01356602|Drug|Placebo|Matching placebo to Canakinumab (PFS), Canakinumab (LYO) and Triamcinolone Acetonide
16204842|NCT01356563|Behavioral|pharmaceutical care|Hemodialysis patients in the intervention group will receive pharmaceutical care delivered by clinical pharmacist, which including personal interview, medication review, medication reconciliation, patient education and recommended actions
16204843|NCT01356550|Drug|RO4917838|single oral dose
16204844|NCT01356524|Drug|Additional vaginal progesterone|The progesterone dose will be raised from 200 mg daily to 300 mg daily
16204845|NCT01356511|Drug|Prednisone|Prednisone, po, 1 mg/kg/d, for 4 weeks.
16204846|NCT01356511|Drug|Dexamethasone|Dexamethasone, po, 40 mg/d, for 4 days.
16204847|NCT01356498|Biological|pegloticase|8 mg intravenous infusion
16204848|NCT01356485|Drug|MP4CO|43 mg/mL pegylated carboxyhemoglobin [≥ 90% CO hemoglobin saturation] in physiological acetate electrolyte solution
16204849|NCT01356485|Drug|Sodium chloride solution|Normal saline (0.9% sodium chloride solution)
16204850|NCT01356472|Drug|Imipenem/cilastatin|the intervention group was designed for combined linezolid plus imipenem for treating MRSA VAP
16204851|NCT01356459|Device|Mepilex Border Dressing|Soft silicone self adherent dressing
16204852|NCT01356446|Procedure|implementation surgical checklist|a checklist according to the suggestions raised by the WHO is implemented
16204853|NCT01356433|Drug|oral vitamin C|"cross-over study,2 arms Arm 1(50cases): is given oral vitamin C 200mg per day in the first 3 months, then stop oral VitC for the next 3 months.
~Arm 2(50cases): is not given vitamin C in the first 3 months, then switch to receive oral VitC 200mg per day in the next 3 months."
16204854|NCT01356433|Drug|oral vitamin C|Arm 2(50cases): is not given vitamin C in the first 3 months, then switch to receive oral VitC 200mg per day in the next 3 months.
16204855|NCT01356420|Dietary Supplement|Cholesterol supplementation|Cholesterol supplementation may be achieved with SLOesterol instead of or in combination with egg yolk. SLOesterol is a powder formulation that contains cholesterol and natural emulsifier. It is considered a medical food developed by Solace Nutrition and available by prescription only.
16204856|NCT01356407|Drug|PICOPREP|
16204857|NCT01356407|Drug|PEG-ELS|
16204858|NCT01356394|Other|dietary intervention|12-week calorie-restricted diet consisting of 50% carbohydrate, 20-25% protein, and 25-30% fat
16204859|NCT01356381|Drug|Vildagliptin|Dosage 50mg b.i.d.
16204860|NCT01356381|Drug|Placebo|50mg bid
16204861|NCT01356368|Drug|Cisplatin, Gemzar, Docetaxel, Alimta|Patients will be assigned to treatment according to the molecular biological results which will analyze excision repair cross-complementing (ERCC1), ribonucleotide reductase subunit M1 (RRM1) and beta-tubulin genes in primary tumor cells which are present in tissues and peripheral blood.
16204862|NCT01356355|Drug|Herbmed plus|one capsule of herbmed plus orally twice a day with meals till the ureteral stent is in situ.
16204863|NCT01356355|Drug|Placebo|One capsule twice a day daily till ureteral stent in situ
16204864|NCT01356355|Drug|Tolterodine|One capsule twice a day daily till ureteral stent in situ
16204865|NCT01356342|Biological|AdimFlu-S 2010-2011, inactivated|"The vaccine contains not less than 90 μg haemagglutinin (HA) per mL. Per mL contains the following three strains: A/California/7/2009 (H1N1)30 μg/mL;A/Perth/16/2009 (H3N2)30 μg/mL;B/Brisbane/60/2008 30 μg/mL
~6 months~<3 years;0.25 mL per injection2 injections at 4 weeks apart
~3~<9 years;0.5 mL per injection2 injections at 4 weeks apart
~9~<18 years;0.5 mL per injection1 injections"
16204866|NCT01356329|Drug|Enoxaparin, Heparin|"Patients who meet the Inclusion Criteria and signed an informed consent will be randomly assigned to 1 of the 2 treatment groups (the Enoxaparin (Group A) and Unfractionated Heparin (Group B)
~). Subjects will be assigned consecutive study numbers according to a predetermined random code generated by the Biostatistician."
16204867|NCT01356316|Biological|AdimFlu-S Vaccine 2010-2011|Per ml contains following strains 30μg, A/California/7/2009 (H1N1), A/Perth/16/2009 (H3N2) and B/Brisbane/60/2008
16204868|NCT01356303|Drug|cisplatin, docetaxel|"All patients met the eligibility criteria will undergo treatment with chemotherapy.
~Each cycle of chemotherapy administration will be started with docetaxel at dose of 75 mg/m2 in 250 ml of Dextrose 5% in Water or Normal Saline administered as a 1-hour intravenous infusion followed by cisplatin at dose of 75 mg/m2 administered as a 2-hour intravenous infusion every 3 weeks per cycle for totally 4-6 cycles."
16204869|NCT01356290|Drug|Bevacizumab|10mg/kg, intravenous (iv), biweekly, 1 year
16204873|NCT01356290|Drug|Etoposide|35-50 mg/m2, oral, alternating 21-day cycles of daily oral etoposide and cyclophosphamide, 1 year
16204874|NCT01356290|Drug|Cyclophosphamide|2.5mg/kg, oral, alternating 21-day cycles of daily oral etoposide and cyclophosphamide, 1 year
16204875|NCT01356290|Drug|Etoposide phosphate|0.5mg, intrathecal, day 1-5, every four weeks, alternating with intrathecal liposomal cytarabine, 1 year
16204876|NCT01356290|Drug|Cytarabine|16-30mg, intrathecal, twice weekly for two weeks out of every four weeks, alternating with intrathecal etoposide phosphate, 1 year
16204877|NCT01356277|Behavioral|Action-focused problem-solving|"Adherence Support Team (patient, parent, Coach)
~standardized education on immunosuppressive medications
~identification of adherence barriers
~'Action-Focused Problem-Solving' to address barriers selected as most important by the patient"
16204878|NCT01356277|Device|Electronic pillbox monitoring, dose reminders, and feedback|"Electronic adherence monitoring with feedback of past 3 months of electronic monitoring data at 3-month intervals
~text message, email, or visual cue dose reminders"
16204879|NCT01356264|Behavioral|multimodal prehabilitation|multimodal prehabilitation program based on exercise, supplemental nutrition and psychological support starting 3-5 weeks before surgery and continuing postoperative for up to 8 weeks
16204880|NCT01356264|Behavioral|multimodal prehabilitation|multimodal prehabilitation program based on exercise, supplemental nutrition and psychological support beginning postoperative and continuing for up to 8 weeks
16204881|NCT01356251|Behavioral|Questionnaires & online virtual support group|Part 1 surveys mesothelioma patients' psychological and physical symptom burden and quality of life by administering a set of questionnaires that covers topics including coping, interpersonal support, mood, anxiety, and overall quality of life. All mesothelioma patients who complete the questionnaires in part 1 will be offered an opportunity to participate in a trial of a therapeutic Internet-based discussion group. The groups will consist of either approximately 3-5 surgical patients or approximately 3-5 non-surgical patients. The groups will run for approximately 60 minutes once a week for six consecutive weeks.
16204882|NCT01356251|Behavioral|Questionnaires & online virtual support group|Part 1 surveys mesothelioma patients' psychological and physical symptom burden and quality of life by administering a set of questionnaires that covers topics including coping, interpersonal support, mood, anxiety, and overall quality of life. All mesothelioma patients who complete the questionnaires in part 1 will be offered an opportunity to participate in a trial of a therapeutic Internet-based discussion group. The groups will consist of either 3-5 surgical patients or 3-5 non-surgical patients. The groups will run for approximately 60 minutes once a week for six consecutive weeks.
16204883|NCT01356238|Other|MRC media|Culture media
16204884|NCT01356238|Other|Sydney IVF media|Culture media
16204885|NCT01356225|Drug|Ketorolac tromethamine|30 mg Intranasal (2 x 100 uL of a 15% solution), single dose
16204886|NCT01356225|Drug|Placebo|IN placebo
16204887|NCT01356212|Drug|Ketorolac tromethamine|30 mg ketorolac (15 mg (100 ul) per nostril) administered intranasally
16204888|NCT01356212|Drug|Ketorolac tromethamine|30 mg ketorolac (15 mg (100 ul) per nostril) administered intranasally
16204889|NCT01356212|Drug|Ketorolac tromethamine|30 mg ketorolac (15 mg (100 ul) per nostril) administered intranasally
16204890|NCT01356199|Dietary Supplement|ARTRONAT|Dietary supplement containing Glucosamine, Chondroïtine and manganese. 6 per day for 8 months.
16204891|NCT01356199|Dietary Supplement|PLACEBO|PLACEBO. 6 per day for 8 months.
16204892|NCT01356186|Behavioral|Post Admission Cognitive Therapy (PACT)|Individual psychotherapy; 6 sessions; 60-90 minutes in duration; administered over preferably 3 days of psychiatric hospitalization
16204893|NCT01356173|Drug|GDC-0349|Oral escalating dose
16204894|NCT01356160|Drug|GS-5885|tablet, 30 mg QD
16204895|NCT01356160|Drug|GS-9451|tablet, 200 mg QD
16204896|NCT01356160|Biological|peginterferon alfa-2a|(solution for injection) 180 µg/week
16204897|NCT01356160|Drug|ribavirin tablet|ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
16204898|NCT01356160|Drug|GS-9451 Placebo|Placebo to match GS-9451 QD
16204899|NCT01356147|Drug|Dornase alfa|2.5 mg nebulized endotracheally every 12 hours for 7 days or until extubation
16204900|NCT01356147|Drug|Placebo|No therapy will be given to placebo arm
16204901|NCT01356121|Drug|Propofol|Propofol will be initiated with a .5-1 mg/kg i.v. bolus followed by repeated 10-20 mg doses at variable intervals (approximately 15 s, at the discretion of the endoscopist/nurse) until an appropriate level of sedation will be achieved.
16204902|NCT01356121|Drug|Midazolam|Midazolam (0.5-1.0 mg) will be administered in a similar fashion with incremental dosing at intervals of approximately 1-3 min until a level of sedation will be achieved
16204903|NCT01356108|Device|Transcatheter Pulmonic Valve Replacement (TPVR) (Edwards SAPIEN™ THV)|The Edwards SAPIEN™ THV is a biological heart valve manufactured with treated bovine pericardial tissue that is mounted into a balloon expandable stainless steel open cell stent. The Edwards SAPIEN™ THV is available in two sizes (23 and 26mm) and is designed for transcatheter implantation in patients with regurgitant pulmonary valved conduit with or without stenosis. This device is commercially available and is used according the current IFU.
16204904|NCT01356095|Other|Knowledge translation intervention|Two part intervention includes an educational outreach intervention for health care workers and a point of care patient education/counselling tool, delivered to providers within health centers randomized to the intervention arm, using a train the trainer on-site training model.
16204905|NCT01356095|Other|Palm-Plus|Clinical guideline and training approach, designed for mid-level healthworkers.
16204906|NCT01356082|Device|CNAP|Non-invasive blood pressure monitor
16204907|NCT01356069|Other|SB-APP|"SB-APP, derived from Brief-Adlerian Psychodynamic Psychotherapy (B-APP) is a time-limited (40 weekly sessions) psychodynamic psychotherapy based on Alfred Adler's theory and delivered in sequential and repeatable modules.
~SB-APP is focused specifically on four personality functioning levels (PFL). These are assessed by the therapists on the basis of symptoms, quality of interpersonal relationships, overall social behaviors, cognitive and emotional patterns, and defense mechanisms"
16204908|NCT01356069|Other|treatment as usual|This treatment consisted in a combination of medication, unstructured psychological support focused on socio-relational impairment and rehabilitative interventions provided by nurses and educators.
16204909|NCT01356056|Device|Kinesia HomeView|Quantifies motor symptom severity in the home
16204910|NCT01356043|Drug|S-amlodipine 5mg,Telmisartan 80mg|S-amlodipine 5mg and Telmisartan 80mg, Oral, Once a day, for 9 days + Wash out (19 days)
16204911|NCT01356043|Drug|S-amlodipine 5mg|S-amlodipine 5mg, Oral, Once a day, for 9 days + Wash out(19 days)
16204912|NCT01356030|Procedure|ERCP|Endoscopic retrograde cholangiopancreatography (ERCP) is usually clinically indicated to place a stent (a plastic or metal tube) in the bile duct. The ERCP procedure is an endoscopic exam during which a small catheter or wire is placed into the bile duct from the point at which it connects to the small intestine. During such a procedure a stent can then be placed to help drain the bile across the site of blockage, and thereby treat your jaundice.
16204913|NCT01356030|Procedure|EUS FNA|Endoscopic ultrasound (EUS) is a procedure in which a flexible tube with a tiny camera and ultrasound probe at the tip is placed through the mouth, down the esophagus, and into the stomach and duodenum (first part of the small intestine where bile flows from the bile duct into the intestine). This allows the doctor performing the EUS to get a much closer view of your pancreas and bile duct. If a suspicious mass is seen, a small sample of the mass (biopsy) is taken using fine needle aspiration (FNA). FNA involves the use of a thin hollow needle to extract cells for diagnostic purposes and is considered safer and less invasive than surgical biopsies.
16204914|NCT01356017|Drug|Telmisartan 80mg, S-amlodipine 5mg|Telmisartan 80mg and S-amlodipine 5mg, Oral, Once a day, for 9 days + Wash out (19 days)
16204915|NCT01356017|Drug|Telmisartan 80mg|Telmisartan 80mg, Oral, Once a day, for 9 days + Wash out (19 days)
16204916|NCT01356004|Drug|live attenuated chicken pox vaccine|Each immunizing dose was given subcutaneously (SC) in the form of 0.5 ml reconstituted vaccine which contains not less than 1033 plaque forming units (PFU) of the attenuated varicella-zoster-virus (VZV), which meets the World Health Organization (WHO) requirements for biological substances and for varicella vaccines. Doses were given 3 weeks apart for a total duration of 12 weeks (3 months).
16204917|NCT01356004|Drug|saline, efficacy|4 doses of SC saline (0.5 ml) -as a placebo- in the same pattern as group A patients
16204918|NCT01355991|Drug|Tiotropium|18mcg/ capsule inhaled once daily for two weeks.
16204919|NCT01355991|Drug|Salmeterol|50mcg inhalation twice daily for two weeks
16204920|NCT01355978|Device|Noninvasive Open Ventilation System|Noninvasive ventilation system
16204921|NCT01355965|Biological|Autologous T cells|
16204922|NCT01355952|Dietary Supplement|Alpha Lipoic Acid|600mg three times per day (1800mg total) daily for 10 weeks
16204923|NCT01355939|Procedure|Clinically-Indicated Abdominal Re-Exploration Surgery|This is a prospective observational study. Abdominal re-exploration surgery is clinically-indicated and planned as the standard of care for the patients regardless of their decision to participate in the study.
16204924|NCT01355926|Other|Flexible Fiber-based CO2 Laser, Quality of Life forms|. Post operative pain will be measured pre-operatively, and post-operatively on post-operative day (POD) 1, 3, 7, 14, 21 and 28 using a numerical pain rating scale. The secondary outcomes will be measured pre-operatively and post-operatively using the University of Washington Quality of Life questionnaire specific for head and neck version 4 (UW-QOL version 4) and the Performance Status Scale for head and neck cancer (PPS-HN) on days 7, 14 and 28. Other secondary aims will be measured intra-operatively and time to return to work and time to normal diet will be measured during timeframes of POD 1, 3, 7,14, 21 and 28.
16204925|NCT01355926|Other|electrocautery resection and quality of life forms|Post operative pain will be measured pre-operatively, and post-operatively on post-operative day (POD) 1, 3, 7, 14, 21 and 28 using a numerical pain rating scale. The secondary outcomes will be measured pre-operatively and post-operatively using the University of Washington Quality of Life questionnaire specific for head and neck version 4 (UW-QOL version 4) and the Performance Status Scale for head and neck cancer (PPS-HN) on days 7, 14 and 28. Other secondary aims will be measured intra-operatively and time to return to work and time to normal diet will be measured during timeframes of POD 1, 3, 7,14, 21 and 28.
16204926|NCT01355900|Procedure|Total knee arthroplasty performed under tourniquet|Comparison of the different tourniquet tactics.
16204927|NCT01355874|Drug|Iferanserin|0.5% iferanserin ointment (containing 10 mg of iferanserin) BID for 14 days during double blind.
16204928|NCT01355874|Drug|Placebo|Placebo ointment BID for 14 days during double blind.
16204929|NCT01355874|Drug|Iferanserin + Placebo|0.5% iferanserin ointment (containing 10 mg of iferanserin) BID for 7 days followed by placebo ointment BID for 7 days during the double blind.
16204930|NCT01355861|Behavioral|Negative work exercise|Submaximal negative work exercise using an isokinetic dynamometer will be performed twice per week for 12 weeks. Exercise volume will be 3 sets of 10 repetitions for the knee and shoulder extensors.
16204931|NCT01355848|Behavioral|Brief Intervention for Suicidality|Focuses on behavioral elements of care, including building rapport, functional analysis, and crisis planning
16204932|NCT01355835|Device|deep brain stimulation (ACTIVA PC, Medtronic)|High frequent deep brain stimulation with variable (best individual) stimulation on subthalamic contacts and standard parameters on nigral contacts (125 Hz, 60µs, best individual amplitude)
16204933|NCT01355822|Drug|PETN|Pentaerythrithyltetranitrate: 80 mg orally twice a day
16204934|NCT01355822|Drug|Placebo control|orally, twice daily
16204935|NCT01355809|Drug|Inhalation gas|Inhalated gas, medicinal oxygen 100% via NIV with Fi O2 0.35, one time by random, 6 minutes
16204936|NCT01355809|Drug|Inhalation Nitrogen/Oxygen|Inhalated gas, Nitrogen/Oxygen (65%/35%), one time by random, 6 minutes
16204937|NCT01355809|Drug|Inhalation Helium/Oxygen|Inhalated gas, Helium/Oxygen (65%/35%) one time by random, 6 minutes
16204938|NCT01355796|Drug|Xylitol|Aerosolized 15% xylitol, 5 ml twice a day for 2 weeks
16204939|NCT01355796|Drug|Hypertonic saline|4 ml of 7 % saline aerosolized twice a day for 2 weeks
16204940|NCT01355783|Drug|E7777|Treatment in both arms is for 6 cycles at 21 days/cycle.
16204941|NCT01355757|Device|Baxter INFUSOR System|Regional Analgesia INFUSOR system with Patient Control Module for post-operative analgesia
16204942|NCT01355757|Drug|Single Injection of Local Anesthetic|Single injection of 20 ml ropivacaine 0.5%
16204943|NCT01355718|Drug|repaglinide|The dosage and frequency, as well as later changes to either dose, frequency or add-on medication (if applicable), will be determined by the physician, according to the patient's requirements.
16204944|NCT01355705|Drug|Amrubicin|40, 60, or 80 mg/m2 intravenous (IV)
16204945|NCT01355705|Drug|Lenalidomide|15 mg daily by mouth
16204946|NCT01355705|Drug|Dexamethasone|40 mg weekly by mouth
16204947|NCT01355705|Drug|Aspirin|81 or 325 mg daily by mouth
16204948|NCT01355705|Drug|Pegfilgrastim|6 mg subcutaneous on Day 2
16204949|NCT01355692|Device|Nd: YLF laser treatment|grid selective retinal treatment
16204950|NCT01355679|Device|Guided Therapy|A total of 14 eligible neuroblastoma patients who are refractory or relapsed on conventional therapy will be treated. Guided therapy will allow the use of any therapeutic combination (up to 4 agents) provided it includes medications contained in the study report. All patients will be followed for disease response, progression and safety. All patients will be treated according to the discretion of the treating oncologist and study committee (minimum 3 oncologists and one pharmacist). Extent of disease will be measured and assessed for changes throughout the course of the study and at 6-8 week intervals (every 2 cycles).
16204951|NCT01355666|Device|DermaTherapy® Linen and underpads.|"DermaTherapy® Linen is a 100% synthetic silk-like fabric technology designed to provide a cleaner, drier and smoother surface between the skin and support systems for a healthy micro-climate.
~Subjects in the DermaTherapy® Linen Group are compared to subjects receiving usual care - bed linen made of cotton-blend fabrics."
16204952|NCT01355653|Device|thermal therapy|heat therapy device, topical, two applications, at 0-3 hours and 4-6 hours on treatment day
16204953|NCT01355653|Device|marketed heatwrap|heatwrap, topical, one time application, 8 hour duration
16204954|NCT01355640|Other|breast-feeding|Mothers lay on the side of the bed comfortably with their infants in their arms after the infants' soiled diapers were changed. Mothers breast-fed their babies. The study was initiated when the infants were observed to have a large amount of areola in their mouth, with flanged lips and active jaw movements. Then two minutes after the breast-feeding, an experienced technician began to do heel lance, heel lance was given by the same experienced technician.Mothers breast-fed their babies two minutes before, during and eight minutes after the heel lance. Throughout the whole procedure, mothers were encouraged to continue breast-feeding when the babies stopped sucking and/or began to cry.
16204955|NCT01355640|Other|non-nutritive sucking|"Mothers lay on the side of the bed comfortably with their infants in their arms after the infants' soiled diapers were changed. Each mother in this group was given a vacuum pacifier( the brand is Goodbaby) to console her baby. Heel lance was given by the same experienced technician. The study was initiated when the infants can suck the pacifier and hold it by himself without others' help. This generally requires half or one minute. Then two minutes after non-nutritive sucking, an experienced technician began to do heel lance. Babies sucked the pacifier two minutes before, during and eight minutes after heel lance. Throughout the whole procedure, mothers were encouraged to continue non-nutritive sucking when the babies stopped sucking and/or began to cry."
16204956|NCT01355627|Procedure|TachoSil®|Primary suture must be performed. Duraplasty may be performed at the discretion of the investigator. TachoSil® must be applied under aseptic conditions during the closure of the dura.
16204957|NCT01355627|Procedure|Current Practice|"Primary suture must be performed. Duraplasty may be performed at the discretion of the investigator.
~In addition to primary suture, whatever means of dura closure deemed necessary by the investigator may be used with the exception of TachoSil®."
16204958|NCT01355614|Drug|QAX576|
16204959|NCT01355614|Drug|Infliximab|
16204960|NCT01355601|Other|Nutritional Beverage|Nutritional Beverage with varying types and levels of carbohydrates
16204961|NCT01355601|Other|Nutritional Beverage|Nutritional beverage with varying types and levels of carbohydrates
16204962|NCT01355588|Drug|Ketorolac Tromethamine|30 mg Ketorolac Tromethamine intranasal (IN)
16204963|NCT01355588|Drug|Ketorolac Tromethamine with 4% Lidocaine hydrochloride (HCl)|30 mg Ketorolac Tromethamine with 4% Lidocaine HCl IN
16204964|NCT01355588|Drug|Ketorolac Tromethamine with 5% Lidocaine HCl|30 mg Ketorolac Tromethamine with 5% Lidocaine HCl IN
16204965|NCT01355588|Drug|30 mg Ketorolac Tromethamine with 6% Lidocaine HCl|30 mg Ketorolac Tromethamine with 6% Lidocaine HCl IN
16204966|NCT01355575|Drug|Rifaximin|Rifaximin tablet, oral administration, 400mg twice daily for 6 weeks.
16204967|NCT01355562|Drug|Interleukin-2 (IL-2)|Daily for 4 doses every 3 weeks for a total of 12 doses in an outpatient setting
16204968|NCT01355549|Biological|Platelet-rich plasma (PRP) therapy|Platelet rich plasma (PRP) describes a new technology in which platelets are isolated from a sample of a person's own blood using simple cell-separating systems such as centrifugation in order to obtain highly concentrated samples of platelets that can be re-injected into an injury site to promote healing.
16204969|NCT01355523|Drug|Melatonin (N-acetyl-5-methoxytryptamine)|6 mg oral melatonin daily 1 hour before bedtime
16204970|NCT01355523|Drug|Placebo|6 mg oral placebo daily 1 hour before bedtime
16204971|NCT01355497|Drug|GTx-024|subjects will be randomized to receive GTx-024 3mg softgel for the duration of the trial.
16204972|NCT01355497|Drug|placebo|subject will receive matching placebo for the duration of the trial
16204973|NCT01355484|Drug|GTx-024|subjects will be randomized to receive GTx-024 for the full duration of the trial.
16204974|NCT01355484|Drug|placebo|subject will receive placebo for the duration of the trial
16204975|NCT01355471|Drug|CD07805/47 Gel|applied topically once daily
16204976|NCT01355471|Drug|Placebo|applied topically once daily
16204977|NCT01355458|Drug|CD07805/47 gel|applied topically once daily
16204978|NCT01355458|Drug|Placebo|applied topically once daily
16204979|NCT01355445|Drug|Vincristine, Irinotecan|"D1 and D8: Vincristine 1.5 mg/m² (max 2mg) direct IV infusion (0.05 mg/kg for patient ≤ 10 kg)
~D1 to D5: Irinotecan 50 mg/m²/d, IV
~cycle / 21 days"
16204980|NCT01355445|Drug|Vincristine, Irinotecan, Temozolomide|"D1 to D5: Temozolomide 125 mg/m²/d, PO (the dose will be escalated to 150 mg/m²/day at cycle 2 for patients who do not experience > grade 3 toxicity of any kind)
~D1 and D8: Vincristine 1.5 mg/m² (maximum 2mg) direct IV infusion (0.05 mg/kg for patient ≤ 10 kg)
~D1 to D5: Irinotecan 50 mg/m²/d, IV
~cycle / 21 days"
16204981|NCT01355432|Other|Observation|There is no intervention, this is an observational study.
16204982|NCT01355406|Device|FlexStent® Femoropopliteal Self Expanding Stent System|Transcatheter over guidewire placement of an intravascular stent(s)
16204983|NCT01355393|Biological|HER-2/neu peptide vaccine|Given ID
16204984|NCT01355393|Biological|sargramostim|Given ID
16204985|NCT01355393|Drug|rintatolimod|Given ID
16205090|NCT01354353|Drug|LY2140023|Administered orally
16204986|NCT01355380|Drug|Inhaled iloprost (Ventavis, BAYQ6256)|Patients treated with inhaled iloprost (Ventavis) 2.5 or 5 micrograms 6-9 times daily
16204987|NCT01355367|Drug|Nifedipine (Adalat, BAYA1040)|BAYA1040 CR 40mg BID
16204988|NCT01355354|Drug|Digoxin|oral tablets, 0.25mg bd on Day 1 and 0.25 Once daily from Day 2 to 15
16204989|NCT01355354|Drug|Fostamatinib|oral tablets, 100mg (2 X 50mg) bd from Day 9 - 15
16204990|NCT01355341|Drug|HERBMED PLUS|500 mg Twice day for 6 month with lunch and dinner.
16204991|NCT01355328|Procedure|laser and radiofrequency|different laser and radiofrequency with different fluences
16204992|NCT01355302|Drug|E7050|E7050 given orally at either 200, 300, or 400 mg once daily.
16204993|NCT01355302|Drug|cisplatin|Cisplatin will be administered at 80 mg/m2 by intravenous infusion over 60 minutes on Day 1 of each 21-day treatment cycle.
16204994|NCT01355302|Drug|capecitabine|Capecitabine will be administered at 1000 mg/m2 orally, twice daily (2000 mg/m2 total daily dose) on Days 1 through 14 of each 21-day treatment cycle.
16204995|NCT01355289|Drug|Avatrombopag|
16204996|NCT01355289|Drug|Placebo|
16204997|NCT01355289|Drug|Pegylated interferon (PEG-IFN)|Participants in Treatment Periods A2, B2, and B3 are to receive antiviral treatment PEG-IFN, ribavirin, or telaprevir. Provided by the sponsor.
16204998|NCT01355289|Drug|Telaprevir|Participants in Treatment Periods A2, B2, and B3 are to receive antiviral treatment PEG-IFN, ribavirin, or telaprevir. Provided by the sponsor
16204999|NCT01355289|Drug|Ribavirin|Participants in Treatment Periods A2, B2, and B3 are to receive antiviral treatment PEG-IFN, ribavirin, or telaprevir. Provided by the sponsor
16205000|NCT01355276|Drug|Cinitapride|cinitapride 1 mg for each dose, 3 mg/daily, for 4 weeks
16205001|NCT01355276|Drug|domperidone|10 mg for each dose ,30 mg/daily, for 4 weeks
16205002|NCT01355263|Drug|iron and vitamin a|
16205003|NCT01355224|Genetic|Genetic|Relative risk estimates will be presented based on individuals' risk for obesity based on FTO genotype results.
16205004|NCT01355224|Behavioral|Lifestyle|Relative risk estimates will be presented based on individuals' risk for obesity due to lifestyle factors.
16205005|NCT01355198|Dietary Supplement|Cysteine (as n-acetylcysteine) and glycine|Cysteine and glycine will be supplemented at doses of 0.81 mmol/kg/d and 1.31 mmol/kg/d for 2 weeks each
16205006|NCT01355198|Dietary Supplement|Cysteine/glycine|Subjects will receive oral dietary amino-acids (cystiene as n-acetylcysteine, and glycine)
16205007|NCT01355172|Biological|AdimFlu-S|0.25mL per injection 2 injections at 4 weeks apart
16205008|NCT01355159|Drug|Folic Acid 4 mg|Folic Acid 1.0 mg or placebo x 4 tablets will be taken daily by oral administration. The majority of women in the study will routinely take 1.0 mg folic acid in a prenatal vitamin supplement, as recommended by their primary obstetrical provider; the study requirements do not require that participants change their practice. Therefore the actual total daily dose may be up to 5.1 mg of folic acid
16205009|NCT01355159|Drug|Placebo|Placebo x 4 tablets will be taken daily by oral administration.
16205010|NCT01355133|Biological|Transurethral intrasphincteric autologous myoblast implantation|Patients undergo upper arm muscle biopsy to isolate and cultivate autologous myoblasts. Using the ultrasound-directed transurethral medical device, 15-18 aliquots (50 - 100 µl per depot) of the 2 ml myoblasts/media suspension are directly injected into the urethral rhabdosphincter at two different levels. The procedure is a single-dose injection of a cell count in range of 1x106 -5x107 cells, depending of the size/quality of the biopsy and quality of outgrowing cells in order to identify possible dose related effects. To possibly enhance cell integration following implantation, a course of transvaginal electrical stimulation is undertaken.
16205011|NCT01355120|Drug|Ipilimumab|Ipilimumab monotherapy 3mg/kg by four infusion every 3 weeks
16205012|NCT01355094|Device|KCI AbThera|"The time that the dressing will be left in place will be left to the discretion of the attending surgeon, but revised practice guidelines mandate either formal abdominal closure or dressing change at 24-96 hours from placement. Upon the first OA dressing change, the surgeon is free to utilize whatever temporary closure they choose.
~Just prior to placement of the dressing, 16 ml (1 table spoon) of blood will be drawn from an existing arterial or venous line (this will qualify as Day 1). The same quantity of blood will be drawn on days 2, 3, 7 and 28 (or hospital discharge, whichever comes first). 15ml of peritoneal fluid will also be collected from the abdomen on the same days or until closure of the abdomen and removal of the dressing."
16205013|NCT01355094|Device|"Stampede VAC"|"The time that the dressing will be left in place will be left to the discretion of the attending surgeon, but revised practice guidelines mandate either formal abdominal closure or dressing change at 24-96 hours from placement. Upon the first OA dressing change, the surgeon is free to utilize whatever temporary closure they choose.
~Just prior to placement of the dressing, 16 ml (1 table spoon) of blood will be drawn from an existing arterial or venous line (this will qualify as Day 1). The same quantity of blood will be drawn on days 2, 3, 7 and 28 (or hospital discharge, whichever comes first). 15ml of peritoneal fluid will also be collected from the abdomen on the same days or until closure of the abdomen and removal of the dressing."
16205014|NCT01355081|Drug|Vortioxetine|Vortioxetine tablets
16205015|NCT01355081|Drug|Placebo|Vortioxetine placebo
16205016|NCT01355068|Drug|Epanutin Infatabs (Phenytoin)|Chewable Tablet, 50 mg, Single dose
16205017|NCT01355068|Drug|Dilantin Infatabs (Phenytoin)|Chewable Tablet, 50 mg, Single dose
16205018|NCT01355029|Behavioral|Stroke Caregiver Education and Support Program|4 week program offered weekly over a 4 week period. Each session is a 2 hour small group guided discussion on the topic area facilitated by 2 trained facilitators. The topics are: Program Introduction, sharing Caregiving Stories and an introduction to Self Management; Community Connections; Session 3 and 4 are chosen by the participants during session 1 from 6 possible options: Communication in your relationship; Cognition, Memory and Personhood; Dealing with your Emotions; Managing your Stress; Changing roles in your relationships and How to be Caregiver Smart?
16205019|NCT01355016|Drug|MDT-637|Inhaled doses of MDT-637 over a 24 hour period
16205020|NCT01354990|Drug|Sitagliptin (JANUVIA®)|Participants prescribed Sitagliptin (JANUVIA®) in routine clinical practice.
16205021|NCT01354977|Drug|Resveratrol|1,000mg twice daily for 28 days
16205022|NCT01354964|Drug|Vitamin D|
16205023|NCT01354964|Drug|Placebo|
16205091|NCT01354353|Drug|Aripiprazole|Administered orally
16205093|NCT01354340|Dietary Supplement|Limicol|6 tablets (Limicol) / day during 1 month and follow-up 1 month without treatment
16205024|NCT01354951|Other|Prostate Biopsy, Focal Brachytherapy , Assessment of QOL|A re-staging transrectal or transperineal ultrasound-guided prostate biopsy as currently performed at participating institutions. Focal brachytherapy will be performed at 8 weeks following the transrectal or transperineal biopsy or sooner if the patient has recovered from the repeat biopsy and the treating physician determines it is safe to proceed with treatment. The regions will be targeted with the prescription dose and receive 144 Gy of Iodine-125 (I-125). The quality-of-life assessment will focus on erectile function, urinary function, bowel function, and general health related quality of life. The patients will complete this assessment at baseline and then approximately 3 ± 1 months, 6 ± 1 months, 12 ± 2 months, 18 ± 2 months, and 24 ± 2 months after treatment.
16205025|NCT01354938|Drug|Clarithromycin modified release 500 mg|Clarithromycin modified release 500 mg was prescribed. The dosage given was either 1 tablet or 2 tablets once a day, depending on the severity of the treatment.
16205026|NCT01354925|Drug|Insulin treatment during Ramadan|Insulin analogs will be used: Levemir and NovoMix70. The daily insulin dose will be calculated as follows: Sixty percent of the total daily dose will be used as the beginning daily dose at the first day of fasting. Sixty percent of the daily dose will be given as NovoMix70 before the Eftar (the main meal in the evening that breaks the fast). Forty percent of the amount will be given as Levemir (Early in the morning before the beginning of fasting.
16205027|NCT01354925|Drug|Standard of care|Standard of care during Ramadan according to physicians decision
16205028|NCT01354886|Drug|FSH-GEX™|single dose
16205029|NCT01354886|Drug|Gonal-f|150 IU single dose
16205030|NCT01354886|Drug|Bravelle|150 IU single dose
16205031|NCT01354886|Drug|Placebo|single dose
16205032|NCT01354860|Other|Moxibustion treatment plus usual care|"Treatment group received moxibustion treatment three times a week for 4 consecutive weeks, totally 12 sessions of treatment in addition to usual care to manage their knee OA.
~Moxibustion points include six local acupuncture points on affected knee joint. Up to two additional tender points will be allowed, if necessary. If participants feel knee pain on both knee joints, study practitioners will provide treatment on both knee.
~We will use smokeless indirect moxibustion made of wormwood with a diameter of 1.9 centirmeter and a length of 2.1 centimeter in a cylindrical form for this study (Haitnim Bosung Inc, Korea). Free participant-practitioner interaction will be allowed during the treatment session. Expected total time of each treatment session will be 40 - 60 minutes."
16205033|NCT01354860|Other|Usual care alone group|"Usual care alone group can receive or use any kind of treatment other than moxibustion treatment provided as study intervention, which includes surgery, conventional medication, physical treatment, acupuncture, herbal medicine, over-the-counter drugs and other active treatment. This also applies to the moxibustion treatment group.
~Education material of information on knee osteoarthritis and current management option and self-exercise sheet with a yoga-mat to enhance regular exercise will be provided in both groups at baseline."
16205034|NCT01354847|Device|Multiple electrode aggregometry analyses (Multiple Electrode Aggregometry, Multiplate(R), Verum Diagnostica, Munich, Germany)|ex vivo platelet aggregation at several intraoperative and postoperative measuring points.
16205035|NCT01354834|Drug|hMG|Patients with a condition
16205036|NCT01354821|Procedure|Endovascular aortic repair|Insertion via bilateral femoral access, stent-graft deployment under fluoroscopic guidance, complementary stenting of visceral arteries, control angiogram
16205037|NCT01354821|Procedure|Open surgical repair|Conventional therapy in France with the national database of the M.O.H.
16205038|NCT01354808|Drug|Dual Anti-Platelet Therapy (DAPT)|"Loading: aspirin 300mg + clopidogrel 600mg
~Maintenance: aspirin 200mg/d + clopidogrel 75mg/d for 1 month"
16205039|NCT01354808|Drug|Triple Anti-Platelet Therapy (TAPT)|"Loading: cilostazol 200mg + aspirin 300mg + clopidogrel 600mg
~Maintenance: cilostazol 100mg bid+ aspirin 200mg/d+ clopidogrel 75mg/d for 1 month"
16205040|NCT01354795|Procedure|1.EUS-FNA with or without suction|During EUS-FNA of the peri-pancreatic mass was performed, with or without self-retracting 10-mL syringe applied.
16205041|NCT01354795|Procedure|2.Pushing the stylet or injecting air|EUS-FNA specimen is expelled from a needle with pushing the stylet or injecting air into the needle
16205042|NCT01354782|Drug|Roflumilast|"Period I: single dose of roflumilast 500 μg orally in the morning.
~Period II: repeated dose of roflumilast 500 μg orally in the morning for 14 days."
16205043|NCT01354769|Device|CapnoStream20|The monitor used for data gathering is a CapnoStream20-multi parameter monitor
16205044|NCT01354743|Drug|Dysport|"Patients entering will be based on gender and assessment of procerus and corrugator muscle mass. Muscle mass will be graded separately for males and females as +, ++, or+++ (light/small, moderate/medium, or heavy/large) by assessment of the procerus/corrugator muscles. Male patients will receive 0.3 mL to 0.4 mL (60, 70, or 80 units) in five equally divided doses of Dysport™ Female patients will receive 0.25 mL to 0.35 mL (50, 60 or 70 units) in equally divided doses of Dysport™ at 5 designated injection sites in the glabellar region
~Subjects will be treated with Dysport™ 20 or 30 units bilaterally to crow's feet.
~Subjects will be treated at baseline and if maximum amount of product has not been used at 1 month follow up subject will receive a touch up. No further treatment will be done for the remaining study visits."
16205045|NCT01354743|Device|Perlane L|The subject will be allowed to receive up to 4 mls between the temporal fossa and the glabella area.
16205046|NCT01354717|Drug|Brand Carac|treatment of actinic keratosis
16205047|NCT01354717|Drug|Generic 0.5% 5-fluorouracil cream|treatment of actinic keratosis
16205048|NCT01354717|Other|Placebo cream|treatment of actinic keratosis
16205049|NCT01354704|Drug|Enoxaparin|enoxaparin 4000 IU 1 injection/day in subcutaneous.
16205050|NCT01354691|Drug|ladostigil hemitartrate|Final dosage strength of 80mg b.i.d will begin at Day 22 following a 21 day dose escalation phase involving 40mg and 60mg b.i.d dosage strengths. Oral, solid dosage.
16205051|NCT01354678|Procedure|NOGA XP Cardiac Navigation System|Intramyocardial multiple precision injection of bone marrow mononuclear cells
16205052|NCT01354678|Procedure|NOGA XP Cardiac Navigation System|Intramyocardial multiple precision injection with placebo
16205053|NCT01354665|Biological|Interferon beta-1b (Betaferon, BAY86-5046)|Patients treated with regular dose of Betaferon injections (250 micrograms subcutaneously every other day) under routine practice setting.
16205092|NCT01354340|Dietary Supplement|Limicol|3 tablets (Limicol) + 3 tablets (Placebo) / day during 1 month and follow-up 1 month without treatment
16205054|NCT01354652|Drug|entecavir, lamivudine|"entecavir: 0.5mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and participants will be followed for the duration of hospital stay, an expected average of 8 weeks.
~lamivudine: 100mg/day p.o until development of lactic acidosis, OLT, death, or improvement of hepatic or renal function to MELD score less than 18 and and participants will be followed for the duration of hospital stay, an expected average of 8 weeks."
16205055|NCT01354626|Other|dietary protein|in the low-protein group 13EN% of protein will be provided in the diet; in the high-protein 25EN% of protein will be provided
16205056|NCT01354626|Other|low-protein|The control group will get a diet which is according to healthy eating guidelines.
16205057|NCT01354613|Drug|Dobutamine|IV administration at the initial study visit (all groups) and at the final study visit for the drug intervention arm (HFpEF group only). Administration of low-dose dobutamine at 5mcg/kg/min and 10mcg/kg/min for periods of approximately 30minutes/dose for purposes of performing a low-dose stress exam on the heart.
16205058|NCT01354613|Drug|Amlodipine|Participants will be randomized to treatment with either amlodipine 5 mg daily or placebo, in double-blind fashion, 25 patients in each group. 12 week oral administration of 5mg/day, uptitrated to 10mg/day, determined by PI.
16205059|NCT01354600|Other|Exercise or Sedentary|Daily cycling exercise at 50% maximal aerobic fitness for a total of ~120 minutes/day or no daily exercise (sedentary)
16205060|NCT01354587|Drug|Hizentra|Subjects transition from Vivaglobin to Hizentra using weekly subcutaneous infusions for 32 weeks.
16205061|NCT01354574|Other|High Glycemic Index meals|Dietary intervention with meals containing high glycemic index carbohydrates. All foods provided to meet the individual's energy needs. Standardized test meal (breakfast)also contained only high glycemic index carbohydrates and energy content was adjusted for each individual, providing 40% of daily energy needs.
16205062|NCT01354574|Other|Low Glycemic Index meals|Dietary intervention with meals containing low glycemic index carbohydrates. All foods provided to meet the individual's energy needs. Standardized test meal (breakfast)also contained only low glycemic index carbohydrates and energy content was adjusted for each individual, providing 40% of daily energy needs.
16205063|NCT01354561|Procedure|Respiratory physical therapy|Respiratory physical therapy using airway clearance techniques was conducted by a physiotherapist according to a detailed clinical evaluation of each patient, consisting of thoracic percussion, manual vibration, postural drainage, and cough stimulation.
16205064|NCT01354548|Device|TheraBite® Jaw Motion Rehabilitation System™|A portable device which utilizes passive motion and stretching to improve mobility and flexibility of the jaw muscles and associated joints. Patients are given written and verbal information about TheraBite before the commencement of Radiotherapy. Investigators instruct on usage and maintenance of TheraBite. Patients are instructed to start a trainings pass by softening the jaw muscles with a simple exercise. The training programme consists of five stretches performed 5 times per day, each stretch held for 15 seconds, training continually during Radiation Therapy and up to one year after completion of Radiation Therapy.
16205065|NCT01354535|Procedure|Isolated Locked Compression Plate|A lateral thigh incision will be used to expose the fracture site. Surgeons will attempt to minimize devascularization of the bone by meticulous dissection and indirect reduction techniques. An appropriate sized plate will be applied to the lateral aspect of the femur. Fracture reduction will be achieved with the use of intra-operative fluoroscopy and the plate will be secured with locking screws.
16205066|NCT01354535|Procedure|Cable Plating and Strut Allograft with Cerclage Wiring|The plate will be placed laterally with the allograft strut placed on the anterior cortex. Screw fixation will be used distal to the stem and cables and screws will be used proximal to the stem tip. Cerclage cables or wires will be used to secure the strut.
16205067|NCT01354522|Drug|Docetaxel, Doxorubicin, Cyclophosphamide|docetaxel 75 mg/m², iv, day 1 doxorubicin 50 mg/m² or epirubicin 75mg/m², iv, day 1 Cyclophosphamide 500 mg/m², iv, day 1 every 3 weeks for 6 cycles
16205068|NCT01354522|Drug|Docetaxel, Cyclophosphamide, Capecitabine|docetaxel 75 mg/m², iv, day 1 Cyclophosphamide 500 mg/m², iv, day 1 capecitabine 950 mg/m2, twice a day, via oral intake, day 1 to day 14 every 3 weeks for 6 cycles
16205069|NCT01354496|Drug|LY2409021 Reference Form|Administered orally
16205070|NCT01354496|Drug|LY2409021 Test-Med Formulation (medium particle size)|Administered orally
16205071|NCT01354496|Drug|LY2409021 Test-High Formulation (high particle size)|Administered orally
16205072|NCT01354496|Drug|LY2409021 Test-Low Formulation (low particle size)|Administered orally
16205073|NCT01354483|Biological|Umbilical Cord Blood Mononuclear Cell|
16205074|NCT01354483|Biological|Methylprednisolone|30mg/kg i.v. methylprednisolone
16205075|NCT01354483|Drug|Lithium Carbonate Tablet|6 weeks
16205076|NCT01354470|Drug|Modafinil|600 mg Modafinil capsule
16205077|NCT01354457|Drug|Epratuzumab and 90Y-Epratuzumab|Sequential injections of each product with an escalating dose for radiolabeled Epratuzumab between patients
16205078|NCT01354444|Drug|Carvedilol|target dose of 25 mg daily which is half the maximum dose used in clinical practice
16205079|NCT01354444|Drug|Placebo|a pill that will look like the active drug but will not contain any carvedilol
16205080|NCT01354431|Biological|nivolumab|Solution, Intravenous (IV), 0.3 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
16205081|NCT01354431|Biological|nivolumab|Solution, Intravenous (IV), 2.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
16205082|NCT01354431|Biological|nivolumab|Solution, Intravenous (IV), 10.0 mg/kg, every 3 weeks (Q 3 weeks), Until Progressive disease (PD), toxicity or discontinue for other reasons
16205083|NCT01354418|Drug|Phenylephrine HCl Extended Release|One phenylephrine HCl 30 mg extended release tablet orally
16205084|NCT01354418|Drug|Phenylephrine HCl Immediate Release|One phenylephrine HCl 10 mg immediate release tablet every 4 hours for three doses
16205085|NCT01354405|Drug|Lanreotide|120 mg every 28 days intramuscular
16205086|NCT01354392|Drug|AZD1152|Up to 6 cycles. Each cycle consists of 800 mg. IV infusion over 96 hrs.
16205087|NCT01354379|Biological|NB-1008|NB-1008 is composed of Fluzone containing 15 micrograms (mcg) of strain-specific hemagglutinin (HA) and 20% W805EC adjuvant.
16205088|NCT01354379|Biological|Fluzone IN|The active control is Fluzone containing 15 micrograms (mcg) of strain-specific hemagglutinin (HA).
16205089|NCT01354366|Other|Infant formula|
16205094|NCT01354340|Other|Placebo|6 tablets (Placebo) / day during 1 month and follow-up 1 month without treatment
16205095|NCT01354327|Dietary Supplement|Limicol|3 tablets / day during 4 months
16205096|NCT01354327|Dietary Supplement|Placebo|3 tablets / day during 4 months
16205097|NCT01354314|Drug|Fluconazole|One 100 MG capsule taken twice daily, 12 hour dosing
16205098|NCT01354314|Drug|Paroxetine|Two 10 MG capsules paroxetine once daily in the evening
16205099|NCT01354314|Drug|Paroxetine and Fluconazole|One capsule 100 MG fluconazole every 12 hours orally per day; Two 10 MG capsules paroxetine orally once daily in the evening
16205100|NCT01354314|Drug|Placebo|One capsule in the morning, three capsules in the evening
16205101|NCT01354301|Drug|Thymoglobulin|intravenously, beginning within the first 24 hours after graft revascularization. Pre-treatment includes hydrocortisone and dipyrone before antithymocyte globulin infusion, which will be reconstituted according to the package insert.
16205102|NCT01354301|Drug|Everolimus|initial 0.75 mg BID dose of everolimus on day 2. Doses will be adjusted from day 5 on to maintain everolimus whole blood trough concentrations between 4-8 ng/ml.
16205103|NCT01354301|Drug|Basiliximabe|days 0 and 4, according to the package insert instructions.
16205104|NCT01354301|Drug|mycophenolate sodium|720 mg BID. This dose will be reduced according to adverse events.
16205105|NCT01354301|Drug|Tacrolimus|0.05 mg/kg BID beginning on day 1. Doses will be adjusted to maintain tacrolimus whole blood trough concentrations between 3-5 ng/ml.
16205106|NCT01354301|Drug|Tacrolimus|0.1 mg/kg BID beginning on day 1. Doses will be adjusted to maintain tacrolimus whole blood trough concentrations between 3-8 ng/ml and 3-5 ng/ml after 3 months.
16205107|NCT01354301|Drug|Tacrolimus|0.1 mg/kg BID beginning on day 1. Doses will be adjusted to maintain tacrolimus whole blood trough concentrations between 3-8 ng/ml.
16205108|NCT01354288|Other|Educational tool|Specific educational tool in order to assess its impact on glycemic control, quality of life, knowledge about the disease and its daily management
16205109|NCT01354275|Other|To compare the IVF/ICSI outcomes of GnRH Antagonist cycle versus GnRH agonist cycle|150 IU FSH dose and OCP plus GnRH Agonist (long luteal) IVF/ICSI cycle and 150 IU FSH dose and OCP plus GnRH Antagonist (Fixed protocol) IVF/ICSI Cycle
16205110|NCT01354275|Other|GnRH Antagonist|GnRH Antagonist cycle; 150 IU FSH and sixth day Antagonist will be administered
16205111|NCT01354262|Dietary Supplement|Vitamin D|600 IU daily oral supplementation
16205112|NCT01354262|Dietary Supplement|Vitamin D|50,000 IU supplementation bi-monthly
16205113|NCT01354249|Dietary Supplement|whey protein plus carbohydrate drink|The CHO-P group received 474 ml (evening drink) or 237 ml (3h prior to operation drink) of a solution containing 14% whey protein (100% lactoalbumin), 86% carbohydrates (45% hydrolyzed corn starch and 55% sucrose) and 0% lipids (Resource® Breeze - Nestlé, São Paulo, Brasil)
16205114|NCT01354223|Device|stenfilcon A contact lens|Randomized to stenfilcon A contact lens worn in a daily wear, daily disposable mode
16205115|NCT01354223|Device|ocufilcon B contact lens|Daily disposable contact lens worn in a daily wear, daily disposable mode
16205116|NCT01354210|Behavioral|SMS Text Message Reminder|Daily
16205117|NCT01354184|Drug|CRD007|
16205118|NCT01354184|Drug|CRD007 matching placebo|
16205119|NCT01354171|Device|MRI assisted TRUS guided biopsy|All subjects to have a confirmatory biopsy at one year. Those assigned ARM 1 to have a TRUS guided biopsy and those assigned to ARM 2to have a MRI assisted TRUS guided biopsy
16205120|NCT01354158|Drug|Droxidopa|Dose titration of placebo, 100mg, 200mg, 400mg of Droxidopa will be given to assess the effects of Droxidopa on blood pressure and cerebral blood flow.
16205121|NCT01354145|Drug|Chondroitin sulfate|Chondroitin sulphate 1200 mg/day, 24 months treatment period
16205122|NCT01354145|Drug|Celecoxib|Celecoxib 200 mg/day, 24 months treatment period
16205123|NCT01354132|Drug|n-acetylcysteine|900 mg effervescent PharmaNAC tablet in water or juice: two tablets in the AM, one tablet in PM
16205124|NCT01354132|Drug|Placebo|Placebo tablets are placed in water or juice in the AM and PM
16205125|NCT01354119|Procedure|Aortic stent-graft|Early intervention with aortic stent-graft
16205126|NCT01354106|Device|Skin Trauma|Each participant completed received both treatment arms, the 3M Micropore and 3M Kind Removal Silicone Tape.
16205127|NCT01354093|Drug|zeaxanthin|10 mg of EyePromise 10 (zeaxanthin) supplement, taken twice a day
16205128|NCT01354093|Drug|zeaxanthin|10 mg of EyePromise 10 (zeaxanthin) supplement, taken once a day
16205129|NCT01354080|Other|massage based on the tensegrity rule|The massage consist of brushing the skin, stroking of the lower abdominal integuments. Elastic deformation of the thoracolumbar fascia. Then the abdominal integuments were elastically deformed by kneading to normalize the rest tension of the muscles of the abdominal integuments as well as, indirectly, the myofascial apparatus of the pelvic floor and in this way improve venous blood and lymph outflow from the large intestine and the sigmoid colon area. The next treatment stage - performing circular movements within the limits of the skin's mobility at 1/3 of the medial part of the thigh. By stroking movements in the direction of the armpit in accordance with the run of the thoracoepigastric and costalaxillary veins. Then the intercostal muscles were deformed.
16205130|NCT01354080|Other|massage - classical abdominal|The classical abdominal massage consisted of circular movements performed on the abdominal integuments by superficial and deep stroking techniques according to the colonic route (clockwise)
16205131|NCT01354067|Behavioral|Control group|The control group receives standardized patient education four times, once every two weeks, during the eight week intervention period. Each session will last 60 minutes, consisting of information regarding anatomy, physiology, causes and mechanisms of COPD, drugs, nutrition, aids and energy saving procedures. The information is the same as for the intervention group, given at separate occasions.
16205132|NCT01354067|Behavioral|High-repetitive single limb training|The high-repetitive single limb exercise regime consists of three sessions per week during eight weeks of exercise training, giving a total number of 24 sessions at each location (Umeå and Huddinge University hospitals). The exercise sessions are supervised and conducted by a physical therapist using a group format, six to eight participants in each group. Each session will span for 60 minutes, duration of the major components are: 10 min warm-up followed by 40 minutes of single limb training and 10min cool-down. In addition this experimental group also receives four sessions of patient education once every two week.
16206454|NCT01343823|Drug|placebo|Administered as two SC 3 mL injections
16205133|NCT01354054|Procedure|High Frequency TENS|100 usec, 100 Hz, pulse amplitude motor - 10%, 30-40 minutes
16205134|NCT01354054|Procedure|Low frequency TENS|100 usec, 4 Hz, pulse amplitude motor - 10%, 30-40 minutes
16205135|NCT01354054|Procedure|Placebo TENS|100 usec, 100 Hz, motor - 10%, pulse amplitude adjusted and maintained for 30 seconds then ramping down to zero in 15 seconds
16205136|NCT01354041|Behavioral|Acceptance and Commitment Therapy|Seven weekly sessions of Acceptance and Commitment Therapy (ACT) intervention
16205137|NCT01354028|Other|Massage therapy|An overall massage time of approximately 10 minutes, administered by physical therapists. Almond oil or baby lotion that is currently used in standard care in the ACH NICU will be used to assist with ease of skin to skin contact during moderate pressure massage. Infants will receive two repetitions of 5-1minute periods of 12 strokes lasting approximately 5 seconds each described in protocol. Actigraph device is on infant's ankle to measure sleep.
16205138|NCT01354015|Device|DRMS|USE OF TEXT MESSAGING SYSTEM
16205139|NCT01353976|Drug|Econazole Nitrate Foam 1%|Econazole Nitrate Foam 1% applied once a day for 4 weeks
16205140|NCT01353976|Other|Vehicle Foam|Vehicle foam applied once a day for 4 weeks
16205141|NCT01353963|Drug|desvenlafaxine succinate|50 mg tablet once daily
16205142|NCT01353937|Drug|AMD3100 injection + rhPDGF-BB topical|drug therapy to be given for the first 2 week duration given on a daily basis initiated during the first visit (Day 0).
16205143|NCT01353924|Biological|Bet v 1aF1-Alum + Bet v 1aF2-Alum|subcutaneous injection of equimolar mixture (20µg each) of Bet v 1aF1-Alum and Bet v 1aF2-Alum, three times in monthly intervals and a booster injection after one year
16205144|NCT01353924|Biological|Alum-Placebo|subcutaneous injection of Alum-Placebo, three times in monthly intervals and a booster injection after one year
16205145|NCT01353911|Drug|Grazoprevir|Orally once daily in AM. Blinded or open-label depending on treatment arm.
16205146|NCT01353911|Drug|Boceprevir|Four 200 mg capsules orally three times daily.
16205147|NCT01353911|Drug|Placebo for Grazoprevir|Orally once daily in AM.
16205148|NCT01353911|Drug|Placebo for Boceprevir|Four capsules orally three times daily.
16205149|NCT01353911|Drug|Peg-interferon alfa-2b|1.5 μg/kg/week subcutaneous injection.
16205150|NCT01353911|Drug|Ribavirin|300 mg to 700 mg orally twice daily.
16205151|NCT01353898|Drug|MK-1972|MK-1972 will be supplied as 25 and 100 mg capsules, and will be given orally, at a dose dependent on the treatment arm; participants will take ten capsules (active drug and/or placebo) once or twice per day for 10 days
16205152|NCT01353898|Drug|Placebo to MK-1972|Placebo will be supplied as matching 25 and 100 mg capsules, and will be given orally, at a dose dependent on the treatment arm; participants will take ten capsules (active drug and/or placebo) once or twice per day for 10 days
16205153|NCT01353872|Dietary Supplement|Nutrattente / Nutraperf / Nutrarecup|500 mL of Nutrattente before each match 500 mL/h of Nutraperf during each match 250 mL of Nutrarecup after each match
16205154|NCT01353872|Dietary Supplement|Nutrattente placebo / Nutraperf placebo / Nutrarecup placebo|500 mL of Nutrattente placebo before each match 500 mL/h of Nutraperf placebo during each match 250 mL of Nutrarecup placebo after each match
16205155|NCT01353859|Drug|tocilizumab [RoActemra/Actemra]|8 mg/kg iv every 4 weeks for a total of 6 infusions
16205156|NCT01353859|Drug|methotrexate|10-25 mg orally weekly
16205157|NCT01353846|Other|observation natural cycle|The patients natural reproductive cycle will be observed and compared to the second arm.
16205158|NCT01353846|Drug|Agonist GnRH; estradiol Valerate; progesterone|Medications: Agonist GnRH Acetate Triptoreline and Acetate Triptorelina and Estradiol Valerate and Natural micronized progesterone, 400 mg/12 hours vaginal administration
16205159|NCT01353833|Drug|Aldesleukin|0.33 ; 1 ; 3 ; 0 millions IU of IL-2 per day for arm 1 to 4, respectively. 1 s.c. injection per day for 5 days.
16205160|NCT01353820|Dietary Supplement|1- Low fat drinkable fermented by Lactobacillus Delbruckii lactis (DN111244) - >10E8 <5.10E9 cfu/mL|1- Intervention with test product ( >10E8 to <5.10E9 cfu/ml of L. delbruckii lactis )
16205161|NCT01353820|Dietary Supplement|2- Low fat drinkable fermented by S. thermophilus and L. bulgaricus|2- Intervention with control product
16205162|NCT01353807|Dietary Supplement|Fish oil|4 1-g gelatine capsules per day providing 2,7 grams long chain n-3 fatty acids
16205163|NCT01353807|Dietary Supplement|Olive oil|4 1-g gelatine capsules with virgin olive oil
16205164|NCT01353794|Drug|Sorafenib (Nexavar, BAY43-9006)|The treatment with Sorafenib 200mg tablets should comply with the recommendations written in the local product information. The decision about the duration of treatment is solely at the discretion of the attending physician
16205165|NCT01353781|Drug|AZD5363|Patients will be given AZD5363 capsules administered orally as a single dose, and then multiple twice-daily dosing following 3 to 7 days washout.
16205166|NCT01353768|Other|retrospective chart review|retrospective chart review
16205167|NCT01353755|Drug|Grass pollen specific immunotherapy|"Strength 1 (0.78μg/mL)
~Strength 2 (6.25μg/mL)
~Strength 3 (50μg/mL)
~Strength 4 (200μg/mL)
~The subcutaneous injections will be administered at intervals of 7 (+ 7 days)during up-titration. For maintenance the injection intervals are prolonged to 4 weeks (+2). The double blind treatment period is 2 years, followed by 1 year open-label treatment for patients previously treated with verum and 3 years open-label treatment for patients previously recieved placebo."
16205168|NCT01353755|Drug|Placabo|Placebo will be administered in the same way as the test product. Placebo will be identical in terms of appearance to the IMP.
16205169|NCT01353742|Drug|Lamivudine|100mg tablet
16205170|NCT01353742|Drug|Adefovir dipivoxil|10mg tablet
16205171|NCT01353742|Drug|Fixed dose combination (Lamivudine and Adefovir dipivoxil)|100mg/10mg capsule
16205172|NCT01353729|Drug|600 mg zanamivir + moxifloxacin placebo|zanamivir 600 mg IV over 30 min x 1 dose + moxifloxacin placebo administered orally x 1 dose
16205173|NCT01353729|Drug|1200 mg zanamivir + moxifloxacin placebo|zanamivir 1200 mg IV over 30 min x 1 dose + moxifloxacin placebo administered orally x 1 dose
16205174|NCT01353729|Drug|zanamivir placebo + moxifloxacin placebo|zanamivir placebo IV over 30 min x 1 dose + moxifloxacin placebo administered orally x 1 dose
16205175|NCT01353729|Drug|zanamivir placebo + 400 mg moxifloxacin|moxifloxacin 400 mg administered orally x 1 dose + zanamivir placebo IV over 30 min x 1 dose
16205297|NCT01352702|Drug|Dabigatran|Patients assigned to this group will receive Dabigatran
16205176|NCT01353716|Drug|Dolutegravir 50 mg|Dolutegravir is an experimental drug in the integrase inhibitor class of HIV medications. There will be a one single dose of 50 mg.
16205177|NCT01353703|Biological|Infanrix hexa™|Intramuscular, three doses
16205178|NCT01353690|Biological|AMDC|Cell Treatment
16205179|NCT01353664|Drug|Romidepsin|The participants will generally continue at the same dose, infusion time and frequency used for the last dose of romidepsin given in the preceding romidepsin study. If the participant entered this rollover study in the middle of a cycle, then the cycle number and cycle day will be carried over from the preceding romidepsin study.
16205180|NCT01353651|Device|Endovascular treatment using self expandable nitinol STENTS|A direct stenting will be performed.
16205181|NCT01353651|Device|Open repair treatment|The surgeon will perform its usual technique to revascularize the common femoral artery
16205182|NCT01353638|Drug|Dipeptiven (Alanyl-glutamine-dipeptide)|Two arms (A and B) and two treatment periods (1 and 2) are scheduled for this study. Each arm includes 14 patients. Schedule arm A: Treatment period 1 with one single peritoneal dialysis exchange (standard PD solution) with Alanyl-Glutamine-Dipeptide as add-on. 17,4 ml Dipeptiven (=3,48g N(2)-L Alanyl-L-Glutamin) will be dissolved at a final concentration of 0,174 %(= 8 mmol/l) in 2 liters of Dianeal®PD4 (at PH:5,5; Glucose-Concentration 3,86 %). After a wash out period (28 days + max 7 days), arm A undergoes treatment period 2, that is one single peritoneal dialysis exchange with standard PD solution without Alanyl-Glutamine-Dipeptide. Schedule Arm B: Treatment period 1 with one single peritoneal dialysis exchange with standard PD solution without Alanyl-Glutamine-Dipeptide followed by wash-out. Treatment period 2 for arm B includes one single peritoneal dialysis exchange with standard PD solution with Alanyl-Glutamine-Dipeptide as add-on. Dosages remain exactly the same.
16205183|NCT01353625|Drug|CC-115|"Part A (actively recruiting): Dose level starts with 0.5mg daily by mouth in cycles of 28 days. Level increases for different patient cohorts in 100% or 50% increments until optimal dose schedule is established for further study. Treatment continues for as long as patient benefits (i.e., until disease progression or unacceptable toxicity).
~Part B: Optimal dose schedule is administered in 28-day cycles until disease progression."
16205184|NCT01353599|Drug|Mometasone furoate|220mcg once daily, for eight weeks
16205185|NCT01353586|Device|nMARQ™ System|The nMARQ™ System is indicated for catheter-based electrophysiological mapping for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillatioon.
16205186|NCT01353573|Radiation|Fixed Gantry Radiosurgery|Single fraction radiosurgery will be prescribed using a fixed gantry radiosurgery delivery system
16205187|NCT01353573|Radiation|Robotic Radiosurgery|Single fraction radiosurgery will be prescribed using a robotic radiosurgery system
16205188|NCT01353534|Biological|A/H5N1 Antigen|A/H5N1 Antigen
16205189|NCT01353534|Drug|Vaccine Enhancement Patch|Vaccine Enhancement Patch
16205190|NCT01353521|Procedure|Contrast-enhanced ultrasound|A contrast-enhanced ultrasound utilizes intravenous gas-filled microbubbles to enhance visualization in real time.
16205191|NCT01353508|Drug|LCZ696|200 mg and 400 mg tablets
16205192|NCT01353508|Drug|Valsartan|160 mg tablets
16205193|NCT01353495|Device|APM Graft (BIOTAPE XMTM)|Patients randomized to the APM group will, following surgical debridement for their diabetic foot wounds, receive a single application of an APM graft (BIOTAPE XMTM, Wright Medical Technology, USA) with dressing changes taking place weekly. All necrotic tissue will be removed from the wound prior to application. BIOTAPE XMTM will be sutured or stapled in place under a silver-based non-adherent dressing (Silverlon, Argenta Medical). Therapy will then be followed by a moisture-retentive dressing (hydrogel bolster) until complete epithelialization has occurred.
16205194|NCT01353495|Other|Wound Debridement|Wounds debrided in both arms of study
16205195|NCT01353482|Drug|Cisplatin|Cisplatin (75mg/m2 iv) wil be administered on day one of a 21 day cycle for up to 6 cycles
16205196|NCT01353482|Drug|Pemetrexed|Patients will be given Pemetrexed (500mg/m2 iv) on day one of a 21 day cycle for up to 6 cycles
16205197|NCT01353482|Drug|Vorinostat|The dose and frequency of vorinostat will be determined in the Phase I study. Vorinostat will be given concurrently with Cisplatin/Pemetrexed.
16205198|NCT01353482|Drug|Placebo|Patients randomised into the placebo arm of the trial will receive Cisplatin and Pemetrexed as standard as well as placebo.
16205199|NCT01353469|Drug|Insulin human/Insuman Comb 25 (HR1799)|"Pharmaceutical form:Suspension
~Route of administration: Subcutaneous"
16205200|NCT01353469|Drug|Insulin human/Novolin® 30R|"Pharmaceutical form:Suspension
~Route of administration: Subcutaneous"
16205201|NCT01353456|Drug|Dexmedetomidine|Patient will receive a loading dose of 1μg/kg (0.25ml/kg) intravenous dexmedetomidine over 10 minutes before induction, and then followed by continuous infusion at a rate of 0.5μg/kg/h (0.125ml/kg/h) until wound closure.
16205202|NCT01353456|Drug|Normal Saline|Same volume as dexmedetomidine given
16205203|NCT01353443|Procedure|Optilene® Mesh Elastic|A number of patients will receive a Optilene® Mesh Elastic mesh, which may not be clinically indicated.
16205204|NCT01353417|Other|In this observational study no study specific intervention is planned|Patients with stable kidney function who already receive Tacrolimus Sandoz© capsules before being included in this non-interventional study, are being observed for 6 months by their attending physicians. Routine medical treatment is provided.
16205205|NCT01353404|Drug|Sequence 1|fenofibrate 65mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral → fenofibrate 160mg, fed condition, per oral
16205206|NCT01353404|Drug|Sequence 2|fenofibrate 65mg, fed condition, per oral → fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral
16205207|NCT01353404|Drug|Seqeunce 3|fenofibrate 65mg, fasting condition, per oral → fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fed condition, per oral
16205208|NCT01353404|Drug|Sequence 4|fenofibrate 65mg, fasting condition, per oral → fenofibrate 65mg, fed condition, per oral → fenofibrate 160mg, fed condition, per oral
16205209|NCT01353404|Drug|Sequence 5|fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral
16205210|NCT01353404|Drug|Sequence 6|fenofibrate 160mg, fed condition, per oral → fenofibrate 65mg, fasting condition, per oral → fenofibrate 65mg, fed condition, per oral
16205211|NCT01353391|Drug|Metformin|500 mg daily OD from randomisation for 2 weeks, then 1000mg BID throughout the duration of pregnancy
16206524|NCT01343303|Drug|Naproxen|500 mg capsule every 12 hours for 21 days
16205212|NCT01353391|Drug|Placebo Comparator|500 mg daily OD from randomisation for 2 weeks, then 1000mg BID throughout the duration of pregnancy
16205213|NCT01353378|Drug|dexmedetomidine|Intravenously injecting 0.125microgram/kg for 10ml IV(in the vein)in group 1, 0.25microgram/kg for 10ml in group 2 within 10 minutes as soon as the operation begin. The control group receives 10mlsaline in 10 minutes.
16205214|NCT01353352|Other|Clinical decision rule - clearing the c-spine|The goal of phase IV of the Canadian C-Spine Rule project is to evaluate the safety and potential impact of an active strategy to empower ED triage nurses to evaluate and clear the c-spine of very low-risk trauma patients.
16205215|NCT01353339|Drug|Levofloxacin|500mg, PO, once daily for 3 months
16205216|NCT01353326|Device|Cormet|Cementless hip resurfacing system
16205217|NCT01353326|Device|Conserve|Cemented hip resurfacing system
16205218|NCT01353313|Drug|Hydrocortisone|"Hydrocortisone sodium succinate for intravenous administration (unpreserved, Solu-Cortef plain, Pfizer®, reconstituted with unpreserved normal saline to avoid exposure to the benzyl alcohol contained in preserved diluents), to be administered either intravenously or orally if no intravenous line is available at the same dose, and tapered as follows:
~4mg/kg/day ¸ q 6 hours x 2 days, then 2mg/kg/day ¸ q 6 hours x 3 days; then
~1mg/kg/day ¸ q 12 hours x 3 days; then 0.5mg/kg/d as a single dose x 2 days"
16205219|NCT01353313|Drug|Placebo|"Saline placebo to be administered either intravenously or orally if no intravenous line is available, at the same dose, and tapered as follows:
~4mg/kg/day ¸ q 6 hours x 2 days, then 2mg/kg/day ¸ q 6 hours x 3 days; then
~1mg/kg/day ¸ q 12 hours x 3 days; then 0.5mg/kg/d as a single dose x 2 days"
16205220|NCT01353300|Genetic|DNA analysis|
16205221|NCT01353300|Genetic|cytogenetic analysis|
16205222|NCT01353300|Genetic|gene expression analysis|
16205223|NCT01353300|Genetic|gene rearrangement analysis|
16205224|NCT01353300|Genetic|mutation analysis|
16205225|NCT01353300|Genetic|polymerase chain reaction|
16205226|NCT01353300|Genetic|polymorphism analysis|
16205227|NCT01353300|Other|laboratory biomarker analysis|
16205228|NCT01353300|Other|medical chart review|
16205229|NCT01353274|Drug|Micamlo|Telmisartan plus Amlodipine T40/A5
16205230|NCT01353248|Drug|GS-5885|tablet, 30 mg QD
16205231|NCT01353248|Drug|Tegobuvir|capsule, 30 mg BID
16205232|NCT01353248|Drug|GS-9451|tablet, 200 mg QD
16205233|NCT01353248|Drug|ribavirin tablet|(weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
16205234|NCT01353248|Drug|GS-5885|tablet, 90 mg QD
16205235|NCT01353235|Drug|Prednisolone|Patients assigned to corticotherapy arm, will receive oral prednisolone 1mg/kg/j as an add on therapy for a maximum of 10 days.
16205236|NCT01353235|Drug|usual care|no drug administered
16205237|NCT01353222|Biological|DN24-02|DN24-02 is an autologous cellular immunotherapy product designed to stimulate an immune response against HER2/neu. It consists of autologous peripheral blood mononuclear cells (PBMCs), including antigen presenting cells (APCs), which are activated ex vivo with a recombinant fusion protein, BA7072.
16205238|NCT01353222|Other|Standard of Care|Observation only until documentation of disease recurrence.
16205239|NCT01353209|Drug|Letrozole|2.5 mg daily for twelve months
16205240|NCT01353209|Drug|Placebo|sugar pill given daily for twelve months
16205241|NCT01353183|Procedure|colonoscopy or rectosigmoidoscopy|Usual procedure
16205242|NCT01353170|Other|Dialysate calcium concentration|Calcium dialysate concentrations: 1.25, 1.35 and 1.5 mmol/l
16205243|NCT01353144|Drug|aspirin|aspirin, 100 mg, qd x 8 weeks
16205244|NCT01353118|Biological|gastric bypass|Optimise glucose control within 3 months before operation
16205245|NCT01353105|Procedure|Ex vivo lung transplantation|Evaluation and reconditioning of lungs following lung transplantation
16205246|NCT01353092|Device|Re5 Pulsating ElectroMagnetic Fields|"Re5 Treatment Helmet using Pulsating ElectroMagnetic Fields (PEMF):
~30 minutes of active PEMF therapy in the morning and 30 minutes of active PEMF therapy in the afternoon"
16205247|NCT01353092|Device|Re5 Pulsating ElectroMagnetic Fields (PEMF)|"Re5 Treatment Helmet using Pulsating ElectroMagnetic Fields (PEMF):
~30 minutes of sham therapy and 30 minutes of active therapy (morning or afternoon)"
16205248|NCT01353079|Biological|Short Ragweed Pollen Allergenic Extract|Daily sublingual administration of Short Ragweed Pollen Allergenic Extract up to 42 U Amb a 1 for a minimum of 8 weeks prior to the ragweed pollen season.
16205249|NCT01353079|Biological|Placebo|Placebo: Glycero-COCAs sublingual
16205250|NCT01353066|Drug|Intensive Medical Treatment|
16205251|NCT01353066|Other|IMM+Roux-en-Y Gastric Bypass (RYGBP)|
16205252|NCT01353040|Drug|AVI-6003|Single intravenous administration
16205253|NCT01353040|Drug|Placebo|Single intravenous administration
16205254|NCT01353027|Drug|Placebo|Normal saline
16205255|NCT01353027|Drug|AVI-6002|Single intravenous administration
16205256|NCT01353014|Other|Dietary advice with genetic information|This group will receive dietary advice for caffeine, vitamin C, sugar and sodium based on genes that affect the metabolism of or sensitivity to caffeine, vitamin C, sugar and sodium.
16205257|NCT01353014|Other|General dietary recommendations|This group will receive general dietary recommendations from recognized health organizations for caffeine, vitamin C, sugar and sodium, with no genetic information.
16205258|NCT01353001|Behavioral|Diet|Participants will be given a calorie and fat gram goal according to their initial bodyweight. The fat gram goals will be set at 20% to 30% of total caloric intake. Subject calorie and fat gram goals are as follows: Subjects weighing less than 175 pounds will receive a diet prescription of 1200 calories and 27 fat grams per day. Subjects weighing between 175 and 219 pounds will receive a diet prescription of 1500 calories and 33 fat grams per day. Subjects weighing between 220 and 249 pounds will receive a diet prescription of 1800 calories and 40 fat grams per day. Subjects weighing greater than 250 pounds will receive a diet prescription of 2100 calories and 47 fat grams per day.
16205298|NCT01352702|Drug|Phenprocoumon|Patients assigned to this group will receive Phenprocoumon
16205299|NCT01352689|Drug|CKD-828(FDC)|Drug: Telmisartan 80mg + S-Amlodipine 2.5mg(FDC) Tablet, Oral, Once Daily
16205300|NCT01352689|Drug|Combination Therapy|"Drug: Telmisatan 80mg Tablet, Oral, Once Daily
~Drug: S-Amlodipine 2.5mg Tablet, Oral, Once Daily"
16205379|NCT01352013|Dietary Supplement|Fatty Acids (placebo)|5ml daily with breakfast for 56 days.
16205259|NCT01353001|Behavioral|Diet Plus Aerobic Training|Participants will receive all of the components as described for the DIET group. Additionally, this group will participate in supervised progressive aerobic training 3 days per week. Participants will be required to attend 3 sessions per week where they will participate in supervised exercise sessions progressing from 60 to 180 minutes per week of moderate-intensity (3.0-6.0 METS) aerobic exercise. 180 minutes per week of exercise will meet the American College of Sports Medicine and the American Heart Association recommendations of 450-750 METS.min.wk-1.
16205260|NCT01353001|Behavioral|Diet plus Resistance Training|Participants will receive all of the components as the DIET group. Participants will also participate in supervised resistance training protocol 3 days per week in the form of an individual session. The protocol will start the participants at a low volume of exercise at an intensity of 50-55% of 1-repetition maximum, and oscillate in both volume and intensity during the intervention, with a general trend toward increases in intensity as outlined in the ACSM Position Stand.
16205261|NCT01352988|Drug|Fumaric acid esters|Starting from 1 tablet Fumaderm® initial per day, with titration up to 6 tablets Fumaderm® per day; in case of side effects, the dose will be adapted to the highest tolerable levels
16205265|NCT01352923|Other|blood test|preparation of blood platelets
16205266|NCT01352910|Device|rTMS|120 pulses 0.2 Hz
16205267|NCT01352910|Device|Sham rTMS|120 pulses 0.2 Hz
16205268|NCT01352884|Drug|AMP-224|Escalating doses of AMP-224
16205269|NCT01352884|Drug|AMP-224|Stage 2 will further explore the safety, pharmacokinetics, and preliminary clinical activity of AMP-224 in at least one tumor type based on pharmacodynamic assessments and clinical activity emerging from the Dose-Escalation Phase. Tumor tissue and blood
16205270|NCT01352871|Behavioral|Concentration / meditation|from 30 minutes before endotoxin administration to 1,5 hrs after endotoxin administration the subject is concentrating / meditating with the goal to influence the innate immune response
16205271|NCT01352871|Drug|lipopolysaccharide|lipopolysaccharide 2ng/kg intravenously
16205272|NCT01352858|Drug|TolDC|Tolerogenic dendritic cells (TolDC), derived ex vivo from autologous monocytes, administered arthroscopically into an inflamed knee following saline irrigation.
16205273|NCT01352858|Drug|Arthroscopy & saline irrigation alone|
16205274|NCT01352845|Biological|rLP2086|0.5 mL dose, given at 0, 2 and 6 months
16205275|NCT01352845|Other|Placebo|0.5 mL dose, given at 0, 2 and 6 months
16205276|NCT01352832|Other|Interactive DVD|"An interactive DVD (How To Talk To Your Doctor about NSAIDs, HTTTYD-NSAIDs) that presents culturally appropriate stories through which a viewer can learn risk factors for adverse effects related to NSAIDs; and communication behaviors for talking about NSAIDs with their doctor."
16205277|NCT01352832|Other|Usual Care|Usual Care
16205278|NCT01352806|Procedure|identification of the lumbar interspinous space using fluoroscopy versus ultrasound versuspalpation|Copmarison of multiple technique for identification of the lumbar interspinous space,which is fluoroscopy,ultrasound and palpation
16205279|NCT01352793|Biological|rLP2086 vaccine|120 mcg, 3 doses, at month 0, 2, and 6.
16205280|NCT01352793|Biological|control|HAVRIX: 720 EL.U. or 1440 EL.Ul, 2 doses, at month 0 and 6. Placebo: normal saline injection, 1 dose, at month 2.
16205281|NCT01352780|Behavioral|Motivational interviewing|"Motivational interviewing technique will be used to improve patient adherence to multiple health behaviour changes and support patients with psoriasis to self- manage effectively. The intervention will discuss on four main topics: diet, physical activity, stress management and psoriasis treatment.
~Motivational interviewing is a patient centered directive counselling technique that focuses on assisting patients to identify their problems and involves exploring ambivalence in an empathic manner. A key goal in motivational interviewing is to increase the importance of change from the client's perspective. This is accomplished by using specific types of open ended questions, selective reflections and reflective listening."
16205282|NCT01352767|Device|InsuPad|Heating pad
16205283|NCT01352741|Drug|Tapentadol Prolonged Release|100 - 500 mg per day orally twice daily for a maximum of 12 weeks
16205284|NCT01352741|Drug|Tapentadol Prolonged Release with Pregabalin|Tapentadol Prolonged Release 100 - 300 mg per day with Pregabalin 150 - 300 mg per day orally twice daily for a maximum of 12 weeks
16205285|NCT01352741|Drug|Tapentadol Prolonged Release open label maintenance|100 - 400 mg per day Tapentadol Prolonged Release orally administered twice daily
16205286|NCT01352728|Drug|Axitinib|5 mg daily for 6 cycle with TACE+Axitinib, Axitinib continued until PD.
16205287|NCT01352715|Drug|Lopinavir/ritonavir|Lopinavir 400mg/ritonavir 100mg (given as two LPV 200mg/RTV 50mg fixed-dose combination tablets) orally twice daily, with or without food, throughout follow-up.
16205288|NCT01352715|Drug|Lopinavir/ritonavir|Lopinavir 400mg/ritonavir 100mg (given as three LPV 133.3 mg/RTV 33.3 mg fixed-dose combination soft gelatin capsules) orally twice daily, with food, throughout follow-up.
16205289|NCT01352715|Drug|Raltegravir|Raltegravir 400 mg tablet orally twice daily, with or without food, throughout follow-up.
16205290|NCT01352715|Drug|Emtricitabine/tenofovir disoproxil fumarate|Emtricitabine 200 mg/tenofovir disoproxil fumarate 300mg fixed-dose combination tablet orally once daily, with or without food, throughout follow-up.
16205291|NCT01352715|Drug|Abacavir/lamivudine/zidovudine|Abacavir 300 mg/lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily, with or without food, throughout follow-up.
16205292|NCT01352715|Drug|Abacavir/lamivudine|Abacavir 600 mg/lamivudine 300 mg fixed-dose combination tablet orally once daily, with or without food, throughout follow-up.
16205293|NCT01352715|Drug|Lamivudine/zidovudine|Lamivudine 150 mg/zidovudine 300 mg fixed-dose combination tablet orally twice daily, with or without food, throughout follow-up.
16205294|NCT01352715|Drug|Abacavir|Abacavir 300 mg tablet orally twice daily or 600 mg (given as two 300 mg tablets) once daily, with or without food, throughout follow-up.
16205295|NCT01352715|Drug|Zidovudine|Zidovudine 300 mg tablet orally twice daily, with or without food, throughout follow-up.
16205296|NCT01352715|Drug|Lamivudine|Lamivudine 150 mg tablet orally twice daily, with or without food, throughout follow-up.
16205301|NCT01352663|Biological|Wockhardt's Insulin Analogue (Recomb)|Basal bolus Wockhardt's Recombinant Insulin Analogue to be injected subcutaneously.
16205302|NCT01352663|Biological|Lantus®|Basal bolus Insulin analog glargine (Lantus®) to be injected subcutaneously.
16205303|NCT01352650|Drug|plerixafor|Cohort 1 will receive plerixafor at a dose of 320 mcg/kg, cohort 2 will receive plerixafor at a dose of 540 mcg/kg and cohort 3 will receive plerixafor at a dose of 810 mcg/kg. Schedule A will receive plerixafor on the 2nd and 4th cycles and Schedule B will receive plerixafor on the 1st and 3rd cycles of treatment.
16205304|NCT01352650|Drug|decitabine|decitabine will be given to all cohorts/schedules at 20 mg/m2 IV daily for a 1-hour infusion on days 1-10 for all cycles
16205305|NCT01352637|Drug|DCS (D-Cycloserine ) + Prolonged Imaginal Exposure|50mg DCS (taken once a week on the day of the therapy session) + Prolonged Imaginal Exposure
16205306|NCT01352637|Drug|DCS (D-Cycloserine ) + Virtual Reality Exposure|50mg DCS (taken once a week on the day of the therapy session) + Virtual Reality Exposure
16205307|NCT01352637|Drug|Placebo + Prolonged Imaginal Exposure|Placebo (taken once a week on the day of the therapy session) + Prolonged Imaginal Exposure
16205308|NCT01352637|Drug|Placebo (sugar pill) + Virtual Reality Exposure|Placebo (taken once a week on the day of the therapy session) + Virtual Reality Exposure
16205309|NCT01352624|Behavioral|$AFE|$teps for Achieving Financial Empowerment ($AFE) is an individualized, psycho-educational intervention that aims to teach veterans with psychiatric disabilities how to save money, create a viable budget, avoid money scams and financial exploitation, and access vocational and mental health resources.
16205310|NCT01352611|Drug|baclofen, intrathecal|Patients will undergo a standard intrathecal baclofen trial procedure. This procedure consists of a single injection of 50 micrograms of baclofen between the 4th and 5th lumbar vertebrae into the spinal fluid.
16205311|NCT01352598|Radiation|stereotactic body radiotherapy|Patients will receive 30 - 40 Gy in 4 - 5 fractions. For high risk patients who also receive external beam radiotherapy, the SBRT will be given as 19 - 21 Gy in 2 - 3 fractions.
16205312|NCT01352585|Drug|Anagrelide hydrochloride|0.5 mg hard capsules, dosing decisions will be made by the treating physician
16205313|NCT01352572|Drug|antidepressant response|Antidepressants administration for 6 weeks under therapeutic dose responders
16205314|NCT01352572|Drug|antidepressant non-response|Antidepressants administration for 6 weeks under therapeutic dose nonresponders
16205315|NCT01352559|Drug|responders|Antidepressants administration for 6 weeks under therapeutic dose
16205316|NCT01352559|Drug|non-responders|Antidepressants administration for 6 weeks under therapeutic dose
16205317|NCT01352546|Biological|BOTOX|150 units of Botox injected intravaginally into the bulbocavernosum, pubococcygeus and puborectalis muscles along the lateral side walls, left and right as a one time injection under anesthesia.
16205318|NCT01352533|Procedure|Running polypropylene closure|Half of every wound will be closed with Standard of Care running polypropylene sutures
16205319|NCT01352533|Procedure|Tissue Adhesive (Derma-Bond)|Approximately half of wounds will be randomized to be closed with tissue adhesive.
16205320|NCT01352533|Procedure|Subcuticular polyglactin-910 combined with tissue adhesive|Approximately half of the experimental wounds will be randomized to be closed with a combination of subcuticular polyglactin-910 and tissue adhesive.
16205321|NCT01352520|Drug|SGN-35|1.8 mg/kg administered by outpatient IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle.
16205322|NCT01352507|Drug|Tadalafil|Administered Orally
16205323|NCT01352507|Drug|Sildenafil|Administered Orally
16205324|NCT01352494|Drug|docetaxel|docetaxel - 75 mg/m2, IV (in the vein), every 3 weeks, 4 cycles
16205325|NCT01352494|Drug|gemcitabine|gemcitabine - 100 mg/m2, IV (in the vein) on day 1 and 8 day of each 28 day cycle, 4 cycles
16205326|NCT01352481|Other|Early parent-based speech intervention program|Seven 1h sessions during a three-month period.
16205327|NCT01352468|Other|Multifaceted cognitive training|Four computerized training tasks
16205328|NCT01352455|Procedure|Hemodialysis|5 days per week hemodialysis
16205329|NCT01352442|Device|AcuFocus Corneal Inlay ACI 7000PDT|corneal inlay
16205330|NCT01352429|Radiation|Proton Therapy|
16205331|NCT01352429|Radiation|IMRT|
16205332|NCT01352416|Drug|Ranolazine|Ranolazine 1000mg (2-500mg tablets) twice daily. Starting 2 days prior to surgery, morning of surgery and up to 14 days post operative depending when the breathing tube is removed from the patient post operative. If intolerant to the study drug due to adverse effects or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500mg (1-500mg tablet) twice daily
16205333|NCT01352416|Drug|Placebo|Placebo 1000mg (2-500mg tablets) twice daily. Starting 2 days prior to surgery, morning of surgery and up to 14 days post operative depending when the breathing tube is removed from the patient post operative. If intolerant to the study drug due to adverse effects or the patient is started on diltiazem or verapamil post operative then the dose will be reduced to 500mg (1-500mg tablet) twice daily
16205334|NCT01352403|Procedure|gastric bypass|
16205335|NCT01352403|Behavioral|intensive life style intervention|
16205336|NCT01352390|Behavioral|Planning Prompt|A prompt to have their child their health test reminder mailing to color
16205337|NCT01352390|Behavioral|Control Condition|A basic reminder mailing will prompt each subject to get a health test as specified on the mailing
16205338|NCT01352364|Other|physiotherapy intervention|a program of physical therapy intervention can match or improve motor skills in the deaf children
16205339|NCT01352351|Behavioral|Breastfeeding promotion intervention|"Breastfeeding counseling during monthly microcredit meetings
~Weekly cell phone messages about breastfeeding"
16205340|NCT01352338|Drug|Lenalidomide, endoxan, prednisone|dose-finding
16205341|NCT01352338|Drug|lenalidomide, endoxan, prednisone|oral therapy with lenalidomide 25mg a day during 3 of 4 week cycles. Number of Cycles: until progression or unacceptable toxicity develops.
16205342|NCT01352325|Behavioral|system constellations seminar|individual-centered intervention in a group setting, duration 3 days
16205343|NCT01352325|Behavioral|system constellations seminar|individual-centered intervention in a group setting, duration 3 days
16205344|NCT01352312|Drug|Bendamustine|Bendamustine at the dose of 50 mg/m2 (or 70 or 90 or 40 mg/m2 depending on the dose level) daily on day 1 and 2.
16206739|NCT01341873|Procedure|quality-of-life assessment|Ancillary studies
16205345|NCT01352312|Drug|Pentostatin|Pentostatin 4 mg/m2 on day 1 of each cycle. For patients with estimated or measured glomerular filtration rate (GFR) 30 to 60 ml/min/m2 pentostatin will be administered at the reduced dose of 2 mg/m2 on day 1 of each cycle.
16205346|NCT01352312|Drug|Ofatumumab|Ofatumumab 300 mg on day 2 of first cycle. Subsequently, from cycle 2 to 6, ofatumumab 1000 mg on day 2 will be administered.
16205347|NCT01352299|Device|Macintosh Laryngoscope blade|Laryngoscopy performed with Macintosh Laryngoscope
16205348|NCT01352299|Device|MacCoy|Laryngoscopy performed with MacCoy Laryngoscope
16205349|NCT01352299|Device|Miller|Laryngoscopy performed with Miller Laryngoscope
16205350|NCT01352299|Device|TrueView|Laryngoscopy performed with TrueView laryngoscope
16205351|NCT01352286|Genetic|Autologous Genetically modified T cells|"Patients will undergo myeloma restaging at days +42, +100, 6 months, 9 months and 1 year post infusion. At this point, in accordance with FDA Guidelines, all patients will enter long term follow up (LTFU) and be followed biannually for monitoring for gene transfer delayed adverse events until year 5 post infusion. From year 5, all patients will require annual LTFU visits for monitoring for delayed adverse events until year 15 after receiving the genetically modified T cells.
~Patients whose disease progresses prior to year 1 will enter LTFU at time of progression; however these patients will be seen quarterly from progression until year 1 post infusion and then follow the LTFU schedule mentioned above."
16205352|NCT01352273|Drug|MEK162 + RAF265|
16205353|NCT01352247|Procedure|Unicompartmental Knee Replacement|A partial knee replacement or UKR involves only the diseased area of the joint being replaced. The healthy compartment of the knee is retained and artificial implants are inserted in place of the diseased area. This is done via a minimally invasive surgical procedure.
16205354|NCT01352247|Procedure|Total Knee Replacement|A total knee replacement involves all surfaces of the knee being replaced. The procedure involves excising both diseased and normal femoral condyles, the tibial plateau and often the patella. This is done through a large skin incision which provides easy access to the knee joint. Each component will be replaced with an artificial implant, which may be cemented in position.
16205355|NCT01352234|Drug|Acetylsalicylic Acid 160 mg|Capsule containing Acetylsalicylic Acid 160mg pill with lactose
16205356|NCT01352234|Drug|Acetylsalicylic Acid 80 mg|Capsule containing Acetylsalicylic Acid 80mg pill with lactose
16205357|NCT01352221|Drug|ST10|30 mg capsules to be taken orally twice a day for 12 weeks in double-blind phase
16205358|NCT01352221|Drug|Placebo oral capsule|Matching placebo capsules for ST10 to be taken orally twice a day for 12 weeks in double-blind phase
16205359|NCT01352208|Drug|ASP9521|oral
16205360|NCT01352195|Behavioral|Forever Free Booklets|Randomized 3-arm design, with 660 smokers recruited into each condition. Assessments will occur at six-month intervals, through 30 months.
16205361|NCT01352182|Drug|Pioglitazone hydrochloride|Participants will receive a daily dose of pioglitazone at 0.5 mg/kg/dose for 5 days.
16205362|NCT01352143|Drug|Recombinant activated factor VII|Plasma will be spiked in vitro with recombinant activated factor VII to assess increases in thrombin generation with and without the drug
16205363|NCT01352143|Drug|Prothrombin Complex Concentrate|Plasma will be spiked in vitro with prothrombin complex concentrate to determine increases in thrombin generation with and without the drug
16205364|NCT01352130|Drug|Ondansetron|Intravenous Ondansetron 8 mgs
16205365|NCT01352130|Drug|Granisetron|Intravenous Granisetron 1 mgs
16205366|NCT01352117|Drug|efavirenz/emtricitabine/tenofovir disoproxil fumarate|600 mg efavirenz/200 mg emtricitabine/300 mg tenofovir disoproxil fumarate taken orally at night
16205367|NCT01352117|Drug|etoposide|50 mg taken orally daily from days 1-7 of each 2-week cycle. For participants without PR or CR after two cycles of therapy and no toxicity greater than Grade 2, the dose of ET was escalated to 100 mg/day orally, days 1-7, every 2 weeks. A cycle could be delayed for a maximum of 14 days. ET could not be initiated prior to 7 days after the last dose in previous cycle. ET could be administered up to a maximum of eight cycles (2 cycles during dose titration and 6 cycles at maximum dose). Participants who could not tolerate escalation of the ET dose to 100 mg/day were treated for a maximum of six cycles.
16205368|NCT01352104|Behavioral|PEP-TE|"PEP-TE for kindergarten teachers of children with externalizing behaviour problems aged 3 to 6 years leads to use classical strategies of changing behaviour (defining rules, appropriate commands, positive and negative consequences) based on the coercive interaction process (cf. Patterson, 1982) as explanatory model for target situations. In 10 units (90-120 minutes) four to six teachers in one group develop individually tailored solutions to specified externalizing behavior problems of the target child. General strategies of improving positive interactions as well as resources and strategies for reducing stress and gaining new energy are discussed. Summary and reflection of the teacher' experiences and ideas of changes in routines prevents relapses."
16205369|NCT01352091|Drug|Zoladex+AI|Patients who took tamoxifen or Fareston for 2-3 years were randomized into 2 groups (335 patients for each group). One group would switch to receive Zoladex 3.6mg depot subcutaneously every month and Aromidex 1mg/d po for another 3-2 years
16205370|NCT01352091|Drug|TAM|Patients who took tamoxifen or Fareston for 2-3 years were randomized into 2 groups (335 patients for each group). One group would receive TAM 20mg/d treated for 3-2 years.
16205371|NCT01352065|Drug|Bosentan|tablet, 250 mg per day, twice per day, 8 weeks
16205372|NCT01352065|Drug|Ambrisentan|tablet, 10 mg per day, single per day, 8 weeks
16205373|NCT01352065|Drug|Placebo|Tablet, 10 mg per day, single per day, 8 weeks
16205374|NCT01352052|Other|interdisciplinary rehabilitation|A two-weeks non-residential, group-based, psycho-educative, multi-component treatment course conducted by an interdisciplinary team consisting of a rheumatologist, a nurse, occupational therapists, physical therapists, and a psychologist. The rehabilitation Programme comprises of a combination of lectures and group discussions, as well as instructions during physical exercise and task performance. The main focus is on education and adaptations in everyday life. There is a scheduled Programme for every day, with a daily time schedule between four and six hours. There will be a maximum of eight participants in each group.
16205375|NCT01352039|Biological|Heparin Sodium - Eurofarma|Heparin Sodium will be given during 5 to 7 days each 8 hours on dosis 5,000 UI
16205376|NCT01352039|Biological|Heparin Sodium - APP Pharmaceuticals|Heparin Sodium will be given during 5 to 7 days each 8 hours on dosis 5,000 UI
16205377|NCT01352026|Drug|Metformin|
16205378|NCT01352013|Dietary Supplement|Omega-3 (oil)|5ml daily with breakfast for 56 days.
16205380|NCT01352000|Behavioral|Smoking Cessation|Approximately 3400 quitline clients will be randomized to one of three conditions at the point of their 2-week follow-up call.
16205381|NCT01351961|Biological|blood sampling|take a sample of blood, 46 ml
16205382|NCT01351961|Procedure|brain MRI and TEP cerebral|magnetic resonance imaging
16205383|NCT01351961|Other|Assessment of cognitive functions|Folstein MMSE, Mac Nair scale, Depression (GDS) scale, The Benton Visual Retention Test, Test of verbal fluency, formal and categorical, Trail Making Test, Grober et Buschke scale (RL/RI-16), Apathy Robert scale, Praxis rating Scale .
16205384|NCT01351961|Other|Electrocardiogram and blood pressure|Electrocardiogramm Blood pressure monitoring
16205385|NCT01351961|Procedure|Vascular explorations|Pulse wave velocity, VWF, IMT
16205386|NCT01351961|Biological|Urine sample|
16205387|NCT01351948|Biological|AdCh63 AMA1 + MVA AMA1 + AMA1-C1/Alhydrogel®+ CPG 7909|5x10^10 vp AdCh63 AMA1 Day 0, 1.25x10^8 pfu MVA AMA1 Day 56, AMA1-C1/Alhydrogel®+ CPG 7909 (80ug, 800ug, 564ug respectively) Day 112. IM injections
16205388|NCT01351948|Biological|AdCh63 AMA1 + AMA1-C1/Alhydrogel®+ CPG 7909|5x10^10 vp AdCh63 AMA1 Day 0,AMA1-C1/Alhydrogel®+ CPG 7909 (80ug, 800ug, 564ug respectively) Day 56. IM injections
16205389|NCT01351948|Biological|AdCh63 AMA1 + AMA1-C1/Alhydrogel®|5x10^10 vp AdCh63 AMA1 Day 0, AMA1-C1/Alhydrogel® (80ug, 800ug respectively) Day 56. IM injections
16205390|NCT01351948|Biological|AdCh63 AMA1 AMA1-C1/Alhydrogel®+ CPG 7909|5x10^10 vp AdCh63 AMA1 Day 0, AMA1-C1/Alhydrogel®+ CPG 7909 (80ug, 800ug, 564ug respectively) Day 112. IM injections
16205391|NCT01351948|Biological|AdCh63 AMA1 + MVA AMA1|5x10^10 vp AdCh63 AMA1 Day 0, 1.25x10^8 pfu MVA AMA1 Day 112. IM injections
16205392|NCT01351935|Drug|AVL-292|125 mg to 625 mg orally, once a day, for 28 days (28 days equals 1 cycle). Number of cycles: until progression or unacceptable toxicity develops
16205393|NCT01351922|Other|No treatment given|Patients will fill out a questionaire by interview.
16205394|NCT01351909|Drug|Cyclophosphamide|Given PO
16205395|NCT01351909|Other|Laboratory Biomarker Analysis|Correlative studies
16205396|NCT01351909|Drug|Veliparib|Given PO
16205397|NCT01351896|Other|Laboratory Biomarker Analysis|Correlative studies
16205398|NCT01351896|Drug|Lenalidomide|Given PO
16205399|NCT01351896|Other|Pharmacological Study|Correlative studies
16205400|NCT01351896|Biological|Pneumococcal Polyvalent Vaccine|Given IM (concurrently or sequentially)
16205401|NCT01351883|Dietary Supplement|ANOM|the ANOM was given 800ml per day before operation, and added from POD2 to POD 14 gradually from 400ml to 1200ml
16205402|NCT01351870|Radiation|Standard Fractionation Regimen|"1.8 Gy daily, 5 fractions per week
~Cranio-spinal axis:
~23.4 Gy in 13 fractions of 1.8 Gy
~Posterior fossa:
~30.6 Gy in 17 fractions of 1.8 Gy"
16205403|NCT01351870|Radiation|Hyperfractionated Radiotherapy|"1 Gy b.d. (minimum interval between fractions 8 hours). 10 fractions per week
~Craniospinal axis:
~36 Gy in 36 fractions of 1 Gy
~Posterior fossa:
~24 Gy in 24 fractions of 1 Gy
~Tumour Bed:
~8 Gy in 8 fractions of 1 Gy"
16205404|NCT01351857|Other|Transition Coordinator|The Transition Coordinator is central to the intervention and will provide ongoing contact with the medical system as well as education and clinical support where appropriate.
16205405|NCT01351844|Behavioral|Education and exercise intervention|An occupational therapist who has clinical experience in hand therapy for breast cancer patients with arthralgia syndrome, will review 4-5 exercises which improve hand range of motion and reduce hand stiffness.
16205406|NCT01351844|Behavioral|Education and General Exercise|A physical therapist with experience in treating breast cancer patients with lymphedema will demonstrate a series of 4-5 general stretching and toning exercises.
16205407|NCT01351831|Other|Rehabilitation with strength training|The rehabilitation programme lasts 1 hour per session, and is performed twice per week for 7 weeks. The rehabilitation program consists of balance-, mobility- and functional training exercises etc. In addition, the participants perform unilateral (operated leg) knee-extensions and leg presses in 2 sets for each strength training exercise, using relative loads of 12 RM (week 1), 10 RM (weeks 2-5), and 8 RM (week 6-7). All sets are performed to failure.
16205408|NCT01351831|Other|Rehabilitation without strength training|The rehabilitation programme lasts 1 hour per session, and is performed twice per week for 7 weeks. The rehabilitation program consists of the same balance-, mobility- and functional training exercises etc. as used in the other experimental arm.
16205409|NCT01351818|Drug|Growth Hormone|
16205410|NCT01351805|Drug|Fish Oil|Subjects will receive marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
16205411|NCT01351805|Dietary Supplement|Vitamin D|Subjects will receive vitamin D3 (cholecalciferol) 2000 IU a day.
16205412|NCT01351805|Other|placebo pill|placebo
16205413|NCT01351792|Drug|Foster® 100/6 µg/unit dose|"Foster® (beclomethasone dipropionate 100 µg plus formoterol 6 µg/unit dose), 2 inhalations b.i.d. (daily dose of BDP extrafine 400 µg plus FF 24 µg)."
16205414|NCT01351792|Drug|Symbicort® Turbohaler® 200/6 μg/actuation|Symbicort® Turbohaler® (budesonide 200 μg plus formoterol fumarate 6 μg/actuation), 2 inhalations b.i.d. (daily dose of BUD 800 μg plus FF 24 μg).
16205415|NCT01351766|Drug|Transdermal Nicotine Patch|Transdermal Nicotine: Participants will use 8 weeks of the nicotine patch at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to participant's initial nicotine level.
16205416|NCT01351753|Drug|Metformin|
16205417|NCT01351753|Drug|Orlistat|
16205418|NCT01351753|Drug|Topiramate|
16205419|NCT01351753|Drug|Placebo|Placebo pills and capsules for metformin, orlistat and topiramate
16205420|NCT01351740|Drug|atazanavir|switch to unboosted atazanavir 400 mg daily
16205421|NCT01351740|Drug|atazanavir/ritonavir|Continue current regimen of atazanavir 300 mg/ ritonavir 100 mg daily
16205422|NCT01351714|Procedure|D3 resection|Radical D3 resection of the right colon through the use of preoperative MDCT angiography
16205423|NCT01351688|Drug|AZD3514|Patients will be given AZD3514 tablets or capsules administered orally as a single dose, and then multiple once-daily dosing following a 7 day washout.
16205424|NCT01351675|Drug|Placebo|Oral, once daily
16205425|NCT01351675|Drug|Bardoxolone Methyl: 20 mg|20 mg, oral, once daily
16205452|NCT01351415|Drug|Docetaxel|Docetaxel 60 or 75 milligram per meter square (mg/m^2) on Day 1 every 21 days.
16205426|NCT01351662|Behavioral|Arthritis Self Management Program|Intervention activities will consist of six weekly sessions of the Arthritis Self-Management Program (ASMP). Sessions will be administered in a group setting with the 15 African American lupus patients randomly assigned to the intervention arm of the study. Fifteen other patients will serve as controls and receive usual care. Patients participating in the stress intervention will receive six weeks of peer led sessions ranging in disease-specific and more general self-help content. The intervention will include homework assignments to practice and record use of session techniques and to complete worksheets regarding session-specific topics and activities. Usual care will include a brief explanation of the disease and relevant literature.
16205427|NCT01351649|Behavioral|middle school physical activity intervention for girls|"Both the Girls on the Move intervention and attention control conditions will involve 2 components: face-to-face (individual) counseling sessions with a school nurse and an after-school (group) program. The intervention for the attention control group will not address physical activity. Both groups will respond to questionnaires at 0 (baseline) and 6 mos. Our Girls on the Move intervention is designed to help girls achieve physical activity recommendations (≥ 60 min. ≥ 5 days/wk.). The motivational, individually tailored counseling sessions with a school nurse and after-school physical activity club (3-5 times a wk. for 6 mos.) are designed to positively influence all cognitive and affective mediating variables of the Health Promotion Model."
16205428|NCT01351636|Drug|Arotinolol Hydrochloride|Antihypertensive medications plus arotinolol hydrochloride, dosage of arotinolol hydrochloride from 2.5mg bid, 2 days later increased to 5mg bid or 10mg bid, for 18 months
16205429|NCT01351636|Drug|Non arotinolol group|Antihypertensive medications without arotinolol for 18 months
16205430|NCT01351623|Drug|Carfilzomib|Following enrollment patients will be treated with single agent infusional carfilzomib at 56mg/m2. Carfilzomib will be administered intravenously over 30 minutes on Days 1, 2, 8, 9, 15 and 16 of a 28-day cycle. Dexamethasone 8 mg PO/IV will be administered prior to all carfilzomib doses during the first cycle.
16205431|NCT01351610|Biological|PTA + Infusion of MSC_Apceth|percutaneous transluminal angioplasty followed by infusion of MSC_Apceth
16205432|NCT01351610|Procedure|PTA|percutaneous transluminal angioplasty only
16205433|NCT01351597|Drug|docetaxel/ oxaliplatin|"docetaxel - 75 mg/m2 with D5W250ml IV (in the vein)over 1 hr, every 3 weeks
~oxaliplatine - 70 mg/m2 with D5W250ml IV (in the vein)over 2 hrs, every 3 weeks"
16205434|NCT01351558|Other|Knee muscle strengthening exercises|Muscle strengthening exercises of the quadriceps and hamstring muscles will be performed based on a standard muscle strengthening exercise paradigm: 3 sets with 6-8 repetitions (corresponding to approximately 80% repetition maximum (RM)) will be performed. The training load will be progressed by means of weekly estimates of muscle strength to ensure a constant load of 80% RM. The exercises will be supervised
16205435|NCT01351558|Other|Upper extremity strengthening exercises|Muscle strengthening exercises of the upper amrs and shoulder girdle will be performed based on a standard muscle strengthening exercise paradigm: 3 sets with 6-8 repetitions (corresponding to approximately 80% repetition maximum (RM)) will be performed. The training load will be progressed by means of weekly estimates of muscle strength to ensure a constant load of 80% RM. The exercises will be supervised
16205436|NCT01351558|Other|Cardiovascular fitness exercises|Cardiovascular fitness exercises encompass circuit training including exercises on (but not limited to): ergometer cycles, treadmills (running), and cross-trainers. The exercise intensity is aiming at exercises within 60-85% of maximum heart rate (defined as 220 - age). The heart rate is monitored using a standard heart rate monitor. The exercises will be supervised
16205438|NCT01351532|Behavioral|smoking cessation program|cross-theoretical model integrating smoking cessation counseling, smoking cessation drug utilization, physician interview and telephone counseling persuasion,
16205439|NCT01351532|Behavioral|Lifestyle counseling|ross-theoretical model integrating smoking cessation counseling,physician interview and telephone counseling persuasion
16205440|NCT01351519|Drug|Aminolevulinic Acid|Aminolevulinic Acid will be administered as a single oral dose of 20mg/kg given in 50ml of water three hours before surgery.
16205441|NCT01351493|Drug|Nitric Oxide|Nitric Oxide Gel, once or twice per day, 12weeks
16205442|NCT01351493|Drug|placebo|placebo Gel, once or twice per day, 12weeks
16205443|NCT01351480|Biological|abatacept|Abatacept administered SC weekly at 125 mg dose
16205444|NCT01351454|Behavioral|ACT HEALTHY|ACT HEALTHY is based on the empirically validated Behavioral Activation Treatment for Depression (BAT-D; Lejuez, Hopko, & Hopko, 2001) and Life Steps, an HIV medication adherence intervention (Safren, Otto, & Worth, 1999). ACT HEALTHY is based on the belief that the best way to improve mood, remain sober, increase medication adherence, and make long-term life changes is by changing and increasing one's activity level. Treatment includes 16 individual sessions over a 12-week period.
16205445|NCT01351454|Behavioral|Nondirective Therapy (NDT)|In NDT, the therapist will create an accepting, nonjudgmental, empathic environment to continuously direct client attention to primary feelings, and to facilitate accepting of affective experience using supportive statements, reflective listening, and empathic communications. In addition, medication adherence is addressed with the Life Steps HIV medication adherence intervention (Safren, Otto, & Worth, 1999). Treatment includes 16 individual sessions over a 12-week period.
16205446|NCT01351441|Behavioral|Medication adherence consultation|Patients will be counseled in person on day 0 then telephonically every month after until day 365.
16205447|NCT01351441|Other|Medication problems assessment|Patients will be asked if they are having any issues that may be attributable to their current drug therapy on a monthly basis. Any issue that is identified will be addressed by the pharmacist.
16205448|NCT01351441|Other|Beer's Criteria Assessment|The patient's drug therapy will be reviewed for Beer's criteria medications and possible alternatives will be addressed by the pharmacist if deemed appropriate.
16205449|NCT01351441|Behavioral|Health Literacy Assessment|Patients will be given a Health Literacy Assessment on day 0 and day 365 using the Realm-SF.
16205450|NCT01351428|Drug|Nifedipine|30-60 mg, twice daily
16205451|NCT01351415|Drug|Bevacizumab|Participants will receive bevacizumab 7.5 or 15 milligrams per kilogram (mg/kg) intravenously.
16205453|NCT01351415|Drug|Erlotinib|Erlotinib 150 mg daily taken on an empty stomach at least one hour before or two hours after the ingestion of food.
16205454|NCT01351415|Drug|Pemetrexed|Pemetrexed 500 mg/m^2 IV over 10 minutes on Day 1 every 21 days.
16205455|NCT01351402|Procedure|Massage or Rest|Participants either received 15 minutes of moderate pressure Swedish massage on the upper back, or rested quietly sitting in a chair for 15 minutes.
16205456|NCT01351389|Behavioral|Brief Motivational Intervention (BMI)|The BMI incorporates open-ended exploration, personalized feedback, and discussion about patients' alcohol use and sexual behaviors and the consequences of these behaviors. Using the central principles described by Miller and Rollnick (2002), the goal of the session, conducted in the hospital as soon as possible, is to explore the patient's alcohol use and sexual behaviors and to help patients consider what they might want to change. Also included is a presentation of personalized feedback, and for patients who are interested in change, a focus on establishing goals for reduced drinking and sexual risk abstinence. Collaboratively the counselor and patient develop a plan for the future, identify goals for behavior change, explore barriers to changes, and provide strategic advice.
16205457|NCT01351389|Behavioral|Brief Advice|Patients in the Brief Advice (BA) condition will receive intervention consistent with standard medical practice when alcohol problems or sex-risk behaviors are indicated. Project staff will offer BA about level of alcohol/drug and sexual behaviors and drug problems risk, and will provide a list of treatment resources (including options for HIV testing) in the local area. Patients will be told they show signs of risk associated with alcohol use in that they scored above a cut-score for our alcohol screen, and that they reported recently engaging in sexually risky behaviors. The staff person will advise patients that reducing their alcohol use, and illicit drug use when relevant, and using condoms is advised. BA will take approximately 5 minutes.
16205458|NCT01351376|Device|Low Level Laser Therapy|Placebo LLL combined with CDT
16205459|NCT01351376|Device|Low Level Laser|Active LLL combined with CDT
16205460|NCT01351363|Device|Electrical pain threshold measurement|Assessment of preoperative pain threshold using electrical stimulation using a Painmatcher machine.
16205461|NCT01351363|Device|Measurement of electrical pain threshold|Measurement of preoperative electrical pain threshold and self reporting of postoperative pain scores (for 4 days) on VAS.
16205462|NCT01351350|Drug|MLN0128|MLN0128 capsules
16205463|NCT01351350|Drug|paclitaxel|paclitaxel intravenous infusion
16205464|NCT01351350|Drug|trastuzumab|trastuzumab intravenous infusion
16205465|NCT01351337|Procedure|diffusion tensor tractography neuronavigation and intraoperative subcortical stimulation|All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation
16205466|NCT01351324|Dietary Supplement|Absence or presence of fish oil|Oral dose of saturated fat with or without fish oil and a heparin infusion
16205467|NCT01351311|Other|Exercise|Resistance Training exercise with swiss ball
16205468|NCT01351311|Other|Drug treatment|Drug treatment
16205469|NCT01351298|Drug|0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride|Decongestant with local anesthetic
16205470|NCT01351298|Drug|0.05% xylometazoline hydrochloride|Decongestant
16205471|NCT01351298|Drug|Isotonic normal saline|Placebo
16205472|NCT01351285|Drug|up-and-down method to find out effective concentration of remifentanil for preventing cough|During the emergence from anesthesia, if the patient did not cough, the extubation was defined as smooth emergence and the predetermined effect site concentration of remifentanil for the subsequent patient was decreased by 0.5 ng/mL. Likewise, if the patient coughed anytime around extubation, it was considered a failed smooth emergence and the predetermined effect site concentration for the next patient was increased by 0.5 ng/mL. This up-and-down method was conducted independently for each of the three groups. EC50 of the remifentanil of each group was obtained using the Dixon's method.
16205473|NCT01351272|Drug|Methylphenidate, non-retard|Medication (methylphenidate, non-retard) will be titrated to optimal response within 6 weeks, with a maximum of 10 mg/day in week 1, 20 mg/day in week 2, 30 mg/day in week 3, 40 mg/day in week 4, 50 mg/day in week 5, and 60 mg/day in week 6, unless adverse effects emerged. After successful adjustment, medication will be maintained until week 6. Dosing will be based on at least two-weekly evaluations by a psychiatrist, including an interview with a review of symptoms and side effects, completion of the Clinical Global Impression (CGI) scale and completion of a standardised Side Effects Rating Scale for psychostimulants (SERS). The maximal daily dosage of MPH is 60 mg. Within this double blind study the same procedure is applied for the placebo condition.
16205474|NCT01351259|Device|Pneumatic device, cylindrical or tapered cuff|Continuous control of cuff pressure using a pneumatic device (Nosten) Cylindrical (Kimberly Clark tube) or tapered (Covidien tube) tracheal cuff
16205475|NCT01351246|Behavioral|CBT Based Self-help Workbook + Counseling Telephone|"Over a period of 12 months parents work through 8 self-help booklets and additionally receive 14 counseling telephone calls. The intervention has a cognitive-behavioral foundation and is based on the therapy manual Therapy program for children with hyperactive and oppositional problem behavior THOP (Döpfner, Schürmann, & Frölich, 2007) and the parent self-help book Wackelpeter and Trotzkopf: Help for parents of children with hyperkinetic and oppositional behavior (Döpfner, Schürmann, & Lehmkuhl, 2006). Primary purpose of counseling telephone calls is to clarify contents of the booklets and support parents in managing their homework assignments accompanied with each booklet."
16205476|NCT01351233|Procedure|Cataract Surgery|Take the operation of phacoemulsification and implant the AcrySof Toric intraocular lens into the capsular bag in high myopic subjects.
16205477|NCT01351220|Behavioral|Educational program and FOBT kits|Subjects will participate in a CRC small group educational program and receive FOBT kits from community health advisors who have received a one-time training session.
16205478|NCT01351220|Behavioral|Educational program and FOBT kits, and technical assistance|In addition to subjects' receipt of a CRC small group educational program and FOBT kits, leadership training and technical support will be provided to the community health advisors and selected leaders and members of the organization.
16205479|NCT01351207|Other|Eggs|Comparison of a high saturated fat/low fiber meal alone, with eggs, and with a protein/cholesterol matched egg-free pudding
16205516|NCT01350973|Drug|Omega-3-acid ethyl esters 90 (TAK-085)|Omega-3-acid ethyl esters 90 (TAK-085) capsules. Each one gram of fatty acid in TAK-085 contains approximately 465 mg of EPA plus 375 mg of docosahexaenoic acid-ethyl as ethyl esters.
16205480|NCT01351194|Procedure|RFA|For PRFA, we used a commercially available system with a 375-KHz computer-assisted radiofrequency generator (Elektrotom HiTT 106, Berchtold, Medizinelektronik, Germany) and an open-perfused electrode (Berchtold, Tuttlingen, Germany) of 15 cm (or 20 cm), 14 Ga, and a 15 mm (or 20 mm) active electrode tip with microbores. The 14 Ga needle was introduced into the center of the tumor; then, 60 W of the radiofrequency energy was delivered by the generator with an 8-minute duration for every single energy application.
16205481|NCT01351194|Procedure|hepatic resection|SR was carried out under general anesthesia using a right subcostal incision with a midline extension.Intra-operative ultrasonography was performed routinely to evaluate the tumor burden, liver remnant, and the possibility of a negative resection margin. Anatomic resection, in the form of segmentectomy and/or subsegmentectomy as described by Makuuchi et al. (16) was the preferred surgical method of liver resection. Pringle's maneuver was routinely used with a clamp and unclamp time of 10 min and 5 min, respectively; this technique was used repeatedly throughout the entire procedure. Hemostasis of the raw liver surface was done with suturing and application of fibrin glue.
16205482|NCT01351181|Behavioral|Leaflet|Advice Leaflet
16205483|NCT01351181|Behavioral|Exercise Advice|Leaflet
16205484|NCT01351181|Behavioral|Normal Care|Normal Care
16205485|NCT01351168|Drug|Levodopa|CD/LD 25/100, 2 tablets test dose based on subject's current CD/LD dosing; single randomized testing day
16205486|NCT01351168|Drug|Zolpidem first dose|Zolpidem will be given at 10 mg on randomized testing day. The randomization is such that the first dose of Zolpidem given to any subject will always be 10 mg
16205487|NCT01351168|Drug|Zolpidem second dose|Zolpidem will be given at 7.5mg or 15 mg depending on the response from the first zolpidem dose.
16205488|NCT01351168|Drug|sugar pill|a sugar pill (placebo) will all be given orally in identical capsules to the other study drugs
16205489|NCT01351155|Device|Skin protective dressing device|Application of one the three indicated devices (3 active arms) to prevent NIV-induced skin injury
16205490|NCT01351142|Other|blood test and cognitive tests|Specific cognitive tests are performed at day 1, month 6, one year and 2 years Specific Blood samples tests are performed at inclusion, 1 years and 2 years
16205491|NCT01351129|Drug|Formulation 1|150-mg immediate release tablet (single dose)
16205492|NCT01351129|Drug|Formulation 2|150-mg modified release capsule, short duration (single dose)
16205493|NCT01351129|Drug|Formulation 3|150-mg modified release capsule, long duration (single dose)
16205494|NCT01351116|Radiation|EBR plus HDRIB|EBR of 20 Gy in 5 daily fractions over one week plus HDRIB of 14 Gy in 2 fractions over two weeks
16205495|NCT01351116|Radiation|EBR|EBR of 20 Gy in 5 daily fractions over one week
16205496|NCT01351103|Drug|LGK974|
16205497|NCT01351103|Biological|PDR001|
16205498|NCT01351090|Drug|Ketorolac tromethamine|10 mg Intranasal (2 x 100 uL of a 5% solution)
16205499|NCT01351090|Drug|Ketorolac tromethamine|30 mg Intranasal (2 x 100 uL of a 15% solution)
16205500|NCT01351090|Drug|Placebo|Intranasal
16205501|NCT01351077|Other|CHICA DevScreen Module|This module assists in the diagnosis and management of developmental screening
16205502|NCT01351064|Other|CHICA ADHD Module|This module was added to CHICA to help diagnose and manage ADHD
16205503|NCT01351038|Drug|Epirubicine, Oxaliplatin, Capecitabine, Panitumumab|3 cycles (repeated q 21d) Epirubicine 50mg/m² i.v. d1 Oxaliplatin 100mg/m² i.v. d1 Panitumumab 9mg/kg i.v. d1 Capecitabine 500mg/m² bid d1-21
16205504|NCT01351025|Drug|atorvastatin|10 mg daily for 4 weeks, if no symptoms or lab findings suggestive of atorvastatin toxicity, dose increase to 20 mg daily from week 4- week 20
16205505|NCT01351025|Drug|atorvastatin|Starting at week 24, 10 mg daily for 4 weeks. If no symptoms or lab findings suggestive of atorvastatin toxicity were found, 20 mg daily from week 28- week 44.
16205506|NCT01351025|Drug|placebo for atorvastin|One tablet once daily for 4 weeks. If no symptoms or lab findings suggestive of toxicity were found, then increase the dose to two tablets once daily.
16205507|NCT01351012|Other|Corn and safflower oil|The oil (60 g/d/3000 kcal) is given in two daily fruit shakes for 4 weeks
16205508|NCT01351012|Other|Canola oil|The oil (60 g/d/3000 kcal providing 3.8 g ALA) is given in two daily fruit shakes for 4 weeks
16205509|NCT01351012|Other|High oleic acid canola oil|The oil (60 g/d/3000 kcal providing 41.2 g oleic acid and 1.2 g ALA) is given in two daily fruit shakes for 4 weeks
16205510|NCT01351012|Other|DHA enriched high oleic acid canola oil|The oil (60 g/d/3000 kcal providing 1.2 g of ALA and 3.6 g of DHA) is given in two daily fruit shakes for 4 weeks
16205511|NCT01351012|Other|Flax and safflower oil|The oil (60 g/d/3000 kcal providing 6.9 g of ALA) is given in two daily fruit shakes for 4 weeks
16205512|NCT01350999|Drug|omega-3-acid ethyl esters 90 (TAK-085)|Omega-3-acid ethyl esters 90 (TAK-085) capsules. Each one gram of fatty acid in TAK-085 contains approximately 465 mg of EPA plus 375 mg of docosahexaenoic acid-ethyl as ethyl esters.
16205513|NCT01350999|Drug|Eicosapentaenoic acid-ethyl (EPA)|EPA-E capsules
16205514|NCT01350986|Behavioral|Cognitive-Behavioral Self-help Workbook + Counseling Telephone Calls|"In intervention period of 5 months parents work through 8 cognitive-behavioral self-help booklets (FLOH) and additionally receive 10 counseling telephone calls. Primary purpose of telephone calls is to clarify content of the booklets and support parents in managing their homework assignments accompanied with each booklet. 3 and 6 months after intervention period has ended, two additional booster telephone calls are provided. The booklets are based on the therapy manual Treatment program for children with hyperactive and oppositional problem behavior (THOP) (Döpfner, Schürmann, & Frölich, 2007) and the parent self-help book Wackelpeter and Trotzkopf: Help for parents of children with hyperkinetic and oppositional behavior (Döpfner, Schürmann, & Lehmkuhl, 2006)."
16205515|NCT01350986|Behavioral|Non-Directive Self-Help Workbook + Counseling Telephone Calls|"In intervention period of 5 months parents are provided 8 non-directive self-help booklets and additionally receive 10 non-directive counseling telephone calls. If the telephone calls are used to clarify content of the booklets or to discuss other child and parenting related topics is at the parents' discretion. Main focus for counselor is to be congruent, empathic and to have unconditional positive regard toward the parents. 3 and 6 months after intervention period has ended, two additional booster telephone calls are provided. The booklets are based on Parent effectiveness training (Gordon, 1970) and Teaching children self-discipline at home and at school (Gordon, 1989)."
16206188|NCT01345812|Drug|HP-HMG|100 - 300 IU for stimulation of women in ART treatment
16205517|NCT01350973|Drug|Eicosapentaenoic acid-ethyl (EPA-E)|EPA-E, 0.6 g, orally, three-times daily for up to 12 weeks.
16205518|NCT01350960|Drug|SPC5001|3 weekly SC injections
16205519|NCT01350960|Drug|Saline 0.9%|3 weekly SC injections
16205520|NCT01350960|Drug|SPC5001|3 weekly SC injections
16205521|NCT01350960|Drug|SPC5001|3 weekly SC injections
16205522|NCT01350960|Drug|SPC5001|3 weekly SC injections
16205523|NCT01350960|Drug|SPC5001|3 weekly SC injections
16205524|NCT01350947|Drug|5-Azacitidine|"Administered on Days 1-7 of each Cycle.
~Subcutaneous administration:
~To provide a homogeneous suspension, the contents of the syringe must be re-suspended by inverting the syringe 2-3 times and vigorously rolling the syringe between the palms for 30 seconds immediately prior to administration.
~The 5-azacitidine suspension is administered subcutaneously.
~Intravenous Administration:
~5-Azacitidine solution is administered intravenously. Administer the total dose over a period of 10-40 minutes."
16205525|NCT01350934|Drug|alendronate 70-mg/vitamin D3 5600 IU combination tablet (Fosamax Plus)|one combination tablet once weekly
16205526|NCT01350934|Drug|Calcitriol|0.25 μg once daily orally
16205527|NCT01350934|Dietary Supplement|Calcium 500 mg|one 500 mg tablet once daily
16205528|NCT01350921|Drug|Ticagrelor|90 mg oral immediate release tablets, single dose on days 1 and 9
16205529|NCT01350921|Drug|Venlaflaxin|37.5 mg oral immediate release tablets, administered twice daily on days 4-8
16205530|NCT01350908|Other|Blood sampling|30mL of peripherical blood will be collected specially for the study. It's an additional blood sampling compare to the normal follow up of the patient.
16205531|NCT01350882|Drug|MabThera|MabThera 500mg/50ml I.V. infusion, single dose : 375 mg/m2
16205532|NCT01350882|Drug|Physiological serum : sodium chloride, sodium citrate|Solution for I.V. infusion Sodium Chloride (pH 6.5), polysorbate 80, sodium citrate (10.0mg/ml)
16205533|NCT01350869|Device|Xience|Patients with Xience
16205534|NCT01350856|Drug|Artesunate 2|Artesunate 2 mg/kg/day for 3 days followed by a full course of either artemether-lumefantrine or DHA-piperaquine or artesunate-mefloquine or artesunate-amodiaquine
16205535|NCT01350856|Drug|Artesunate 4|Artesunate 4 mg/kg/day for 3 days followed by a full course of either artemether-lumefantrine or DHA-piperaquine or artesunate-mefloquine or artesunate-amodiaquine
16205536|NCT01350843|Dietary Supplement|Orange Juice|250ml of orange juice or a sugars matched orange drink daily
16205537|NCT01350830|Procedure|anterior hernia repair|Inguinal incision is made, external oblique divided and the cord is encircled after identifying ilioinguinal and iliohypogastric nerves. The sac is dissected and reduced, in case of direct hernia the posterior wall of inguinal canal is plicated with polypropylene suture; in presence of indirect hernia the sac is reduced and a stitch is passed in manner that the deep ring is snug about the cord. A pre-shaped mesh is positioned on the floor of the canal around the cord with the two tails overlapping laterally; the mesh is then anchored to the pubic tubercle. External oblique is reapproximated with the cord transposed in the subcutaneous space and skin is sutured.
16205538|NCT01350830|Procedure|transinguinal preperitoneal patch repair|Through a 5-cm inguinal incision external oblique fascia is divided, cremasteric fibers are separated and the elements of the cord are skeletonized. Indirect or direct hernia is approached and through the hernia orifice, the sac is reduced, preperitoneal space is accessed and dissected to allow easily placement of the patch facilitated by the memory recoil ring. In case of indirect hernia the lateral part of patch is split and the two tails sutured around vas and gonadic vessels. Hernia orifice is closed with a polypropylene stitch through transversalis fascia and the mesh; external oblique is closed followed by skin approximation.
16205539|NCT01350817|Drug|Erlotinib + docetaxel|docetaxel :75 mg/m² IV day 1 every 3 weeks with erlotinib:150 mg/d per os d2-d16
16205540|NCT01350817|Drug|Docetaxel|docetaxel :75 mg/m² IV day 1 every 3 weeks.
16205541|NCT01350804|Biological|AIN457|AIN457 (Secukinumab) is a human monoclonal antibody. Secukinumab binds and reduces the activity of Interleukin 17 (IL-17). AIN457 was given as i.v. (10mg/kg) at baseline, week 2 and week 4, and then s.c. (75 or 150mg) every 4 weeks starting at week 8.
16205542|NCT01350804|Biological|Placebo|Placebo was given as i.v. at baseline, week 2 and week 4, and then s.c. every 4 weeks starting at week 8.
16205543|NCT01350804|Biological|Abatacept|Abatacept (from 500 to 1000 mg i.v. based on weight) was given as i.v. at baseline, weeks 2 and 4, and then every 4 weeks starting at week 8.
16205544|NCT01350765|Behavioral|Intervention|The LHWs of the selected intervention areas would receive additional training on ENC for identification, management and referral for birth asphyxia, lbw and neonatal sepsis.
16205545|NCT01350765|Behavioral|Control|The LHWs in the control areas would perform their routine tasks as assigned to them by their program
16205546|NCT01350752|Behavioral|RDTs & Provider Training on Malaria Diagnosis and Treatment|In Cameroon and Nigeria, malaria RDTs will be made available in health facilities and health care providers will receive training and job aids on malaria diagnosis and treatment. The training course covers the following topics: clinical and parasitological diagnosis of malaria, how to use a rapid diagnostic test, algorithm based on malaria test result, recommended treatment for confirmed malaria cases (including dosage and regimen for artemisinin-based combination therapies), advice for treatment of test-negative patients
16205547|NCT01350752|Behavioral|Extended provider training (Cameroon only)|2-day training course which supplements basic provider training on malaria diagnosis and treatment, which focuses on understanding change in malaria treatment guidelines, professionalism, and communication skills
16205548|NCT01350752|Behavioral|School based malaria education (Nigeria only)|Schools will be invited to undertake activities to raise awareness about malaria RDTs and treatment among children and community members. The intervention includes training teachers on peer health education, malaria awareness activities and providing support to hold a malaria educational event
16205549|NCT01350739|Procedure|intraumbilical incision|vertical, intraumbilical incision
16205550|NCT01350739|Procedure|infraumbilical incision|incision at the inferior boarder of the umbilicus, circular
16205551|NCT01350713|Drug|povidone iodine|one local application of 10% povidone iodine ointment
16205552|NCT01350700|Other|Scars assessment & QOL|Scar assessment and quality of life questionnaires
16205553|NCT01350674|Procedure|EBUS-TBNA|endobronchial ultrasound transbronchial needle aspiration
16205941|NCT01347918|Dietary Supplement|sterculia|7g of sterculia will be ingested over one week together with the normal breakfast.
16205554|NCT01350635|Biological|BM32|BM32 will be applied in sterile phosphate buffer solution. Drug will be applied in concentrations of 11,33 and 100 micrograms/ml
16205555|NCT01350622|Drug|PENNSAID|active treatment with PENNSAID and oral placebo. Subjects will apply 40 drops of Pennsaid to the affected ankle joint once, and will take a single placebo pill.
16205556|NCT01350622|Drug|Diclofenac hydroxyethylpyrrolidine|active treatment oral Diclofenac and PENNSAID placebo. Patients will take a single 50mg dose of oral diclofenac and will apply 40 drops of placebo lotion (2.3% DMSO) to the affected ankle once.
16205557|NCT01350609|Drug|Nifedipine/Candesartan (BAY 98-7106)|Fixed dose combination of 60 mg nifedipine + 32 mg candesartan (1 tablet in one period)
16205558|NCT01350609|Drug|Nifedipine (Adalat, BAY A1040) and Candesartan (Atacand, BAY 12-9333)|Loose combination of 1 tablet nifedpipine 60mg (Adalat LA) and 2 tablets candesartan 16mg (Atacand) (3 tablets in one period) .
16205559|NCT01350596|Drug|Alivium®|400mg of Ibuprofen equivalent to 8mL (50mg/mL) oral suspension of the Reference Drug
16205560|NCT01350596|Drug|Ibuprofen|400mg of Ibuprofen equivalent to 8mL (50mg/mL) oral suspension of the Test Drug
16205561|NCT01350583|Drug|Sodium Bicarbonate (NaHCO3)|Treatment consisted of 0.15 g/kg/day Sodium Bicarbonate (NaHCO3) increasing to 0.3 g/kg/day after 1 week if well tolerated. Further dose increment to 0.6 g/kg/day was to be done after 2 weeks of starting sodium bicarbonate if prior dose levels were well tolerated.
16205562|NCT01350570|Other|acupuncture|acupuncture group1, acupoints ST25 and BL25 will be used in this trial.
16205563|NCT01350570|Other|acupuncture group2|Acupoints LI11 and ST37 will be used in this group. LI11 is located at upper limb while ST37 is located at the lower limb.
16205564|NCT01350570|Other|acupuncture group3|All acupoints used in acupuncture group1 and group2 will be used in this group.
16205565|NCT01350570|Drug|Loperamide|Loperamide will be used in this group for a dose of 2mg a time, three time a day.
16205566|NCT01350557|Other|Comprehensive care|Comprehensive care consisted of subacute care plus health-maintenance interventions to manage depressive symptoms, manage malnutrition, and prevent falls.
16205567|NCT01350557|Other|Subacute care|Subacute care included geriatric consultation, continuous rehabilitation, and discharge planning.
16205568|NCT01350544|Behavioral|Treatment Advocacy|Treatment advocacy is a 24-week intervention with booster sessions, including a 4-week intensive intervention followed by a 20-week maintenance period. In the first 4 weeks, all participants receive 4 individual weekly 60-minute sessions and 1 group HIV education session. In the next 20 weeks, all participants receive booster sessions in weeks 12 and 20, and a counselor check-in phone call in week 8 regarding need for new referrals and adherence barriers. Participants who have not demonstrated good adherence (≥90%) during the prior 2 weeks receive ≤4 additional booster sessions at weeks 14, 16, 22, and 24. Clients receive additional linkage with APLA's social service programs, as necessary.
16205569|NCT01350531|Behavioral|Skills training|This component includes skills most proximal to adhering to the eating and weight loss plan (e.g., calorie counting, making healthy food choices, measuring food portions, scheduling snacks and meals, meal planning, completing food logs daily, following an exercise plan).
16205570|NCT01350531|Behavioral|Contingency Management|Contingency management uses behavioral principles to counteract the reinforcing mechanisms of food and inactivity.
16205571|NCT01350518|Dietary Supplement|Benefiber|"Benefiber® powder will be used as our dietary supplement intervention. Benefiber® powder contains wheat dextrin, a 100% natural fiber. Participants in the intervention arm will receive 3 supplement packets to be consumed per day.
~Each active dietary supplement packet contains 8 grams of Benefiber® powder and 3 grams of TRUE® lemon flavoring, a 100% natural with no artificial ingredients or sweeteners, preservatives, sodium or gluten."
16205572|NCT01350518|Dietary Supplement|TrueLemon|Each placebo dietary supplement packet contains 8 grams of Splenda and 3 grams of TRUE® Lemon sweetener. Each packet is designed to be added to 8 oz of fluid. The three packets should be consumed each day in a total of 24 fluid ounces.
16205573|NCT01350505|Behavioral|White light exposure|~200 lux of broad spectrum white light
16205574|NCT01350505|Behavioral|Dim white light exposure|~28 lux of broad spectrum white light
16205575|NCT01350505|Behavioral|Very dim white light exposure|<0.5 lux of broad spectrum white light
16205576|NCT01350505|Behavioral|Dim orange light exposure|~28 lux of orange light
16205577|NCT01350492|Behavioral|Resistance Exercise Training|16 weeks of resistance exercise training for the treatment of chronic muscle pain compared to wait-list control
16205578|NCT01350453|Behavioral|LifeCIT|Participants will be asked to aim to wear the C-MIT for 9 hours a day for 5 days/week, including 4-6 hours of structured activities per day: two 30-60 minute sessions of web-based activities and 3-4 hours practicing everyday activities.
16205579|NCT01350453|Behavioral|Standard Care|Participants will receive their usual care from their NHS provider.
16205580|NCT01350440|Biological|IVIG|Intravenous Immune Globulin
16205581|NCT01350427|Dietary Supplement|Leucine supplementation|1 bout of resistance exercise and supplementation of 4.0 g of leucine + 5.6 g of alanine
16205582|NCT01350427|Dietary Supplement|BCAA supplementation|1 bout of resistance exercise and supplementation of 4.0 g of leucine + 2.8 g of isoleucine + 2.8 g of valine
16205583|NCT01350427|Dietary Supplement|Alanine supplementation|1 bout of resistance exercise and supplementation of 9.6 g of alanine
16205584|NCT01350414|Device|Bronchial Thermoplasty with the Alair System|Bronchial Thermoplasty with the Alair System
16205585|NCT01350401|Genetic|Autologous genetically modified T cells, NY-ESO-1ᶜ²⁵⁹T|Cytoreductive chemotherapy followed by infusion of NY-ESO-1ᶜ²⁵⁹T
16205586|NCT01350388|Drug|Febuxostat|80 mg/day of febuxostat for 24 weeks
16205587|NCT01350388|Drug|Placebo|1 placebo tablet per day for 24 weeks
16205588|NCT01350375|Drug|Botox|
16205589|NCT01350375|Drug|Saline|
16205590|NCT01350362|Drug|tideglusib|1000 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension.
16205591|NCT01350362|Drug|tideglusib|1000 mg of tideglusib as a powder for oral suspension once every other day in an overnight fasted state for 26 weeks/extension
16205592|NCT01350362|Drug|tideglusib|500 mg of tideglusib as a powder for oral suspension once daily in an overnight fasted state for 26 weeks/extension.
16205593|NCT01350362|Drug|Placebo|Powder for oral suspension administered once daily in an overnight fasted state for 26 weeks/extension.
16205594|NCT01350349|Behavioral|Problem Adaptation Therapy (PATH)|Problem Adaptation Therapy (PATH) focuses on the subject, the caregiver, and the subject's home-environment, to encourage problem-solving and adaptive functioning. The goal of PATH is to decrease depression and disability.
16205595|NCT01350349|Behavioral|Supportive Therapy|Supportive Therapy assists subjects in expressing their feelings and focusing on their strengths and abilities in working through current difficulties and transitions.
16205596|NCT01350336|Device|Alair System|Treatment of airways with the Alair System
16205597|NCT01350323|Procedure|Aqueous sample|Aqueous sample (0.1ml of aqueous)+ intravitreal injection of bevacizumab (1.25mg/0.05ml)
16205598|NCT01350323|Procedure|Aqueous sample|Aqueous sample (0.1ml)+intravitreal injection of bevacizumab (1.25mg/0.05ml)
16205599|NCT01350323|Procedure|Aqueous sample|Aqueous sample (0.1ml)+ intravitreal injection of bevacizumab (1.25mg/0.05ml)
16205600|NCT01350323|Procedure|Aqueous sample|Aqueous sample (0.1ml)
16205601|NCT01350310|Procedure|Intramyocardial injection|Electromechanical mapping will be used to identify viable myocardium (unipolar voltage >6.9 mV) and intramyocardial injections in the target areas will be performed with NOGA catheter (25 injections of 0.3 cc).
16205602|NCT01350310|Procedure|Intracoronary injection|Patients will undergo myocardial perfusion scintigraphy for myocardial viability assessment. Microcatheter will be placed in the mid segment of the coronary artery supplying the segments of reduced tracer accumulation and repeated intracoronary injections of stem cell solution will be performed.
16205603|NCT01350310|Procedure|Intramyocardial injection|Procedure/Surgery: Intramyocardial injection Electromechanical mapping will be used to identify viable myocardium (unipolar voltage >6.9 mV) and intramyocardial injections in the target areas will be performed with NOGA catheter (25 injections of 0.3 cc).
16205604|NCT01350297|Procedure|reinnervation|anastomosis between right inferior laryngeal nerve and right phrenic nerve
16205605|NCT01350284|Dietary Supplement|Cinnamon|acute oral administration of 3 g cinnamon
16205606|NCT01350284|Dietary Supplement|Placebo control|3 g wheat flour (placebo)- separated by 28 days from cinnamon intervention
16205607|NCT01350271|Drug|Mebendazole polymorph A and C 500 mg|Mebendazole tablets produced by the State Pharmaceutical Manufacturing Corporation of Sri Lanka, containing 500mg of mebendazole as a 50:50 mixture of Polymorphs A and C
16205608|NCT01350271|Drug|Mebendazole polymorph C|Mebendazole tablets manufactured by the State Pharmaceutical Manufacturing Corporation of Sri Lanka, containing 500mg dose of mebendazole as Polymorph C alone
16205609|NCT01350271|Drug|Placebo|Placebo tablets produced by the State Pharmaceutical Manufacturing Corporation of Sri Lanka
16205610|NCT01350258|Drug|Fludarabine|Part of the conditioning regimen
16205611|NCT01350258|Drug|Thiotepa|Part of the conditioning regimen
16205612|NCT01350258|Radiation|Total Body Irradiation (TBI)|There is one fraction of total body irradiation (2Gy) as part of the conditioning regimen.
16205613|NCT01350258|Biological|Donor Lymphocyte Infusion (DLI)|Immediately following the conditioning regimen of fludarabine, thiotepa, and TBI, the patient receives a set dose of their donor's T cells (DLI), After the DLI, the donor's T cells will react with the remaining parts of the recipients immune system.
16205614|NCT01350258|Drug|Melphalan|Two days after the DLI, Melphalan will be given to eliminate the reacting T cells to avoid graft versus host disease. Non-activated T cells should not be affected by the Melphalan and remain to help fight infection.
16205615|NCT01350258|Device|Hematopoietic stem cell transplantation (HSCT)|"One day after the Melphalan ends, the patient will receive their donor's stem cells. This is the actual day of transplant.
~The CliniMACS® Plus Instrument will be used for the selection of human CD34+ hematopoietic stem and progenitor cells in human allogeneic hematopoietic stem cell transplantation."
16205616|NCT01350245|Radiation|Total Body Irradiation (TBI)|Total body irradiation is given in 8 fractions over 4 days (total dose of 12 Gy).
16205617|NCT01350245|Biological|Donor Lymphocyte Infusion (DLI)|After TBI, the patients will receive a dose of 2 x 10e8 of their donor's T cells. After this infusion, the patients will have 2 rest days.
16205618|NCT01350245|Drug|Cyclophosphamide|Cyclophosphamide is administered 2 days after the DLI to help tolerize the donor T cells. It is given at a dose of 60 mg/kg/d for 2 days
16205619|NCT01350245|Drug|Mycophenolate Mofetil (MMF)|Started the day before the transplant to prevent graft versus host disease (GVHD)
16205620|NCT01350245|Drug|Tacrolimus|Started the day before the transplant to prevent graft-versus-host disease (GVHD)
16205621|NCT01350245|Device|Hematopoietic stem cell transplantation (HSCT)|"One day after the cyclophosphamide is finished, the patients will receive a CD34 selected-donor stem cell product. This is the day of transplant.
~The CliniMACS® Plus Instrument will be used for the selection of human CD34+ hematopoietic stem and progenitor cells in human allogeneic hematopoietic stem cell transplantation."
16205622|NCT01350232|Drug|Fludarabine|Subjects will receive fludarabine at a dose of 30 mg/m2 daily for 4 days as part of the preparative regimen
16205623|NCT01350232|Drug|Cytarabine|Subjects will receive cytarabine at a dose of 2 g/m2 daily for 4 days, approximately 4 hours after the fludarabine
16205624|NCT01350232|Device|Cellular Infusions|"Subjects will receive the cellular product in 2 steps. The first is a lymphocyte infusion of 2 X 10e8 lymphocytes/kg on the day they receive total body irradiation. The second is a CD34 enriched stem cell product approximately 48 hours after the cyclophosphamide.
~The CliniMACS® Plus Instrument will be used for the selection of human CD34+ hematopoietic stem and progenitor cells in human allogeneic hematopoietic stem cell transplantation."
16205625|NCT01350232|Radiation|Total Body Irradiation|All subjects will receive 200cGy TBI in a single fraction on the AM they receive the lymphocyte infusion
16205626|NCT01350232|Drug|Cyclophosphamide|All subjects will receive cyclophosphamide at a dose of 60 mg/kg at approximately 72 and 96 hours after the lymphocyte infusion
16205627|NCT01350232|Drug|Bortezomib|Subjects will receive bortezomib 1.3 mg/kg on Day 1,4,8, and 11 of a 21 day cycle. This will be repeated for 2 cycles.
16205628|NCT01350232|Drug|Rituximab|Subjects will receive rituximab 375 mg/m2 on day 1 and day 8 of a 21 day cycle, on days they will also be receiving rituximab. This will be repeated for 2 cycles.
16205629|NCT01350232|Procedure|Plasmapheresis|Subjects who continue to have detectable anti-donor antibody will receive plasmapheresis to reduce the antibody further
16206032|NCT01347255|Drug|Daivobet® ointment|once daily application, 4 weeks
16205630|NCT01350219|Device|Stem Cell Educator|For the treatment, commonly the left (or right) median cubital vein, a patient's blood is passed through a Blood Cell Separator that isolates the lymphocytes from the blood according to the recommended protocol by manufacture; consequently, the collected lymphocytes were transferred into the Stem Cell Educator and treated by CB-SC; after that, the educated cells return the blood back to the patient via a dorsal vein of hand. During the MCS+ collection, the whole blood flow rate was maintained at 35 mL/min. The whole procedure was scheduled for 8 ~ 9 hrs.
16205631|NCT01350206|Procedure|hepatic resection|HR was carried out under general anesthesia using a right subcostal incision with a midline extension. Intraoperative ultrasound was routinely performed. Pringle's maneuver was routinely used with a clamp/unclamp time of 10 minutes/5 minutes.Thrombectomy was performed according to the location and extent of PVTT. The en bloc technique was used for patients if the portal vein branch could be ligated with a sufficient safety margin between its root and the tip of the thrombus
16205632|NCT01350206|Procedure|TACE|TACE with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg )mixed with iodized oil lipidol
16205633|NCT01350193|Device|Manuka Honey|The use of the nasal irrigation on post-operative day #1. 30mL of the nasal irrigation will be applied to each nostril by a 60mL Toomey syringe (given to patient at pre-operative clinic visit) twice a day (once in am, once in pm). This will continue until the 6 month post-op visit.
16205634|NCT01350193|Other|Saline Irrigation|The use of the nasal irrigation on post-operative day #1. 30mL of the nasal irrigation will be applied to each nostril by a 60mL Toomey syringe (given to patient at pre-operative clinic visit) twice a day (once in am, once in pm). This will continue until the 6 month post-op visit.
16205635|NCT01350167|Procedure|Screening|"Triphasic CT of the abdomen with and without contrast every 12 months and alpha-fetoprotein testing every 6 months. Repeated until HCC diagnosed for up to 10 years.
~Ultrasound of the upper left quadrant every 6 months with alpha-fetoprotein testing every 6 months. Repeated until HCC diagnosed for up to 10 years."
16205636|NCT01350154|Drug|Sildenafil|20 mg in gelatine capsules, oral, three times daily
16205637|NCT01350154|Drug|Placebo|Lactose monohydrate oral in gelatine capsules, 3 times daily
16205638|NCT01350141|Other|Placebo|An infusion lasting approximately 60 minutes
16205639|NCT01350141|Drug|PF-04950615 (RN316)|An infusion lasting approximately 60 minutes
16205640|NCT01350141|Drug|PF-04950615 (RN316)|An infusion lasting approximately 60 minutes
16205641|NCT01350128|Drug|PT001 MDI|PT001 MDI administered as two puffs BID for 7 days
16205642|NCT01350128|Drug|Ipratropium Bromide HFA Inhalation Aerosol|Taken as 2 inhalations of the 17 µg per actuation strength MDI QID
16205643|NCT01350128|Other|Placebo MDI|Matching placebo to PT001 MDI administered as two puffs BID for 7 days
16205644|NCT01350115|Drug|LDE225|supplied as 100 mg capsules
16205645|NCT01350115|Drug|Placebo|supplied in capsules
16205646|NCT01350102|Drug|Bacitracin|Participants will be treated with Bacitracin to their wound until 100% wound healing, which may take up to 6 months to achieve.
16205647|NCT01350102|Drug|AmeriGel®|Participants will be treated with AmeriGel® to their wound until 100% wound healing, which may take up to 6 months to achieve.
16205648|NCT01350102|Dietary Supplement|Vitamin C|Participants will be treated with Vitamin C supplements 1000 mg daily until 100% wound healing, which may take up to 6 months to achieve
16205649|NCT01350089|Drug|Placebo (without alcohol, caffeine, energy drink)|(carbonated) water (volume equivalent to 46.5 g ethanol (inform of vodka (37.5%)) (carbonated) water (250 ml), artificial fruit juice (21 g/L prepared with (carbonated) water). The final volume of the mixture is 500 mL.
16205650|NCT01350089|Drug|Comparator 1 (with alcohol; without caffeine and energy drink)|Mixture of 46.5 g ethanol (inform of vodka (37.5%)), (carbonated) water 250 mL, artificial fruit juice (21 g/L prepared with (carbonated) water). The final volume of the mixture 500 mL.
16205651|NCT01350089|Drug|Comparator 2 (with alcohol and caffeine; without energy drink)|Mixture of 46.5 g ethanol (inform of vodka (37.5%)), caffeine (80 mg), (carbonated) water (250 ml), artificial fruit juice (21 g/L prepared with (carbonated) water) The final volume of the mixture is 500 mL.
16205652|NCT01350089|Drug|Comparator 3 (with alcohol and energy drink)|Mixture of 46.5 g ethanol (inform of vodka (37.5%)), Red Bull® Energy Drink (250 mL, without flavour mixture to optimize blinding), artificial fruit juice (21 g/L prepared with (carbonated) water).The final volume of the mixture is 500 mL.
16205653|NCT01350076|Drug|conventional liberal fluid regimen|Control group will receive conventional liberal fluid regimen with crystalloid Liberal fluid regimen = Maintenance fluid + fasting fluid + dehydration + third space loss Maintenance fluid = (4X BW 1-10 kg) + (2X1BW11-20 kg) + (1X BW 0ver 21 kg) Fasting fluid = maintenance fluid X fasting duration
16205654|NCT01350076|Drug|restricted fluid regimen|"Study group will receive restricted fluid regimen (the same as control group except third space replacement) plus goal directed fluid therapy to maintain adequate CO guided by USCOM as shown in diagram (figure 1).
~Figure 1 goal directed fluid therapy SVV = Stroke volume variation SVI = Stroke volume index CI = Cardiac index"
16205655|NCT01350063|Drug|Sodium dichloroisocyanurate (NaDCC) tablet (Aquatab)|One tablet should be added to 10L container, resulting in a free chlorine dose of 2 mg/L.
16205656|NCT01350063|Device|Water storage container (Jerry can)|Shallow tubewell water should be stored in 10L container.
16205657|NCT01350063|Other|No intervention|
16205658|NCT01350050|Drug|articaine|"Articaine is intermediate-acting local anesthetic (amide type). Like other local anesthetic drugs, articaine causes a transient and completely reversible state of anesthesia (loss of sensation) during (dental) procedures.
~In dentistry, articaine is used both for infiltration and block injections."
16205659|NCT01350050|Other|9% Sodium Chloride solution for injection|9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. Each mL contains sodium chloride 9 mg. It contains no bacteriostat, antimicrobial agent or added buffer.
16205660|NCT01350037|Drug|alfentanil|Alfentanil is a potent but short-acting synthetic opioid analgesic drug, used for anaesthesia in surgery. It is an analogue of fentanyl with around 1/10 the potency of fentanyl and around 1/3 of the duration of action, but with an onset of effects 4x faster than fentanyl.It is an OP3 mu-agonist.Alfentanil is administered by the parenteral (injected) route for fast onset of effects and precise control of dosage.
16205701|NCT01349803|Drug|Formoterol Fumarate 12 μg (Foradil® Aerolizer®)|Formoterol Fumarate 12 μg (Foradil® Aerolizer®) administered BID for 14 days
16205661|NCT01350037|Drug|remifentanil|Remifentanil is a potent ultra short-acting synthetic opioid analgesic drug. It is given to patients during surgery to relieve pain and as an adjunct to an anaesthetic. Remifentanil is used for sedation as well as combined with other medications for use in general anesthesia. The use of remifentanil has made possible the use of high dose opioid and low dose hypnotic anesthesia, due to synergism between remifentanil and various hypnotic drugs and volatile anesthetics.It is administered in the form remifentanil hydrochloride and in adults is given as an intravenous infusion in doses ranging from 0.1 microgram per kilogram per minute to 0.5 (µg/kg)/min.
16205662|NCT01350024|Procedure|Frontal nerve block with 2% lidocaine with 1:100,000 dilution of epinephrine|Frontal Nerve Block 5 cc will be administered preoperatively once.
16205663|NCT01350024|Procedure|Subconjunctival injection of 2% lidocaine with 1:100,000 dilution with epinephrine|Patients will receive a 1.5 cc dose of subconjunctival lidocaine as above
16205664|NCT01350011|Behavioral|Innovative System|In IS, they will receive motivational counseling at months 3,6,12, and 18. If they decide to quit smoking they will be offered up to 10 sessions of behavioral counseling and access to NRT (nicotine patch and gum) If they relapse on NRT, they will be offered varenicline, if it is not contraindicated.
16205665|NCT01350011|Behavioral|Standard Treatment Control (STC)|Participants will receive self help information and referrals for counseling and for pharmacological treatment.
16205666|NCT01349998|Drug|Product 33525|Daily dosing for 2 weeks each recurrence for patients with tinea pedis and Daily dosing for 1 week each recurrence for patients with tinea cruris and tinea corporis
16205667|NCT01349985|Other|AGATE|AGATE is a web-based adherence-enhancement intervention accessible via smartphone. All participants will be prescribed naltrexone, 50 mg, once daily for eight weeks.
16205668|NCT01349985|Other|SASED|Participants will receive SASED, a web-based alcohol and side-effects diary via smartphone. All participants will be prescribed naltrexone, 50 mg, once daily for eight weeks.
16205669|NCT01349972|Drug|alvocidib|Given IV
16205670|NCT01349972|Drug|daunorubicin hydrochloride|Given IV
16205671|NCT01349972|Drug|mitoxantrone hydrochloride|Given IV
16205672|NCT01349972|Drug|cytarabine|Given IV
16205673|NCT01349959|Drug|Azacitidine|Given SC
16205674|NCT01349959|Drug|Entinostat|Given PO
16205675|NCT01349959|Other|Laboratory Biomarker Analysis|Correlative studies
16205676|NCT01349959|Other|Pharmacological Study|Correlative studies
16205677|NCT01349933|Drug|Akt inhibitor MK2206|Given PO
16205678|NCT01349920|Drug|Infliximab|Infliximab administered intravenously at a dose of 5 mg/kg at study Weeks 0, 2, 6, 14, and 22.
16205679|NCT01349907|Drug|Asenapine|One flavored asenapine sublingual tablet (containing either 2.5, 5 or 10 mg asenapine) twice daily (BID), starting at 2.5 mg on Day 1 for three consecutive days. Normally on Day 4, the dose will increase to 5 mg BID beginning with the evening dose. Normally on Day 7, the dose will increase to 10 mg BID beginning with the evening dose. The dose may be up-titrated earlier than Days 4 and 7 at the investigator's discretion. Beginning on Day 8 (or after at least 1 day on 10 mg BID), asenapine dosing will be flexible (2.5, 5, or 10 mg BID) until up to Week 50.
16205680|NCT01349907|Drug|Rescue medication|For participants whose symptoms worsen or are not adequately controlled on assigned treatment, rescue medication may be administered during the trial in the following circumstances. For the control of agitation, anxiety, insomnia, restlessness, or akathisia and extrapyramidal symptoms (EPS) some benzodiazepines (i.e., lorazepam [up to 4 mg/day] or an equivalent dose of short-acting benzodiazepines) and EPS medications (i.e., anticholinergics) are allowed. Benadryl (diphenhydramine) and beta blockers are also permitted, provided that they are not taken within 8 hours of efficacy assessments.
16205681|NCT01349894|Device|SNaP® Wound Care System|Wound dressing applications using customized system. Dressing applications changes per manufacturer recommendation.
16205682|NCT01349881|Drug|Eflornithine placebo & sulindac placebo|Eflornithine placebo 2 tablets PO daily for 3 years. Sulindac placebo 1 tablet PO daily for 3 years
16205683|NCT01349881|Drug|eflornithine & sulindac placebo|Eflornithine two 250 mg tablets PO daily for 3 years. Sulindac placebo 1 tablet PO daily for 3 years.
16205684|NCT01349881|Drug|Eflornithine placebo & sulindac|Eflornithine placebo 2 tablets PO daily for 3 years. Sulindac one 150 mg tablet PO daily for 3 years.
16205685|NCT01349881|Drug|Eflornithine plus sulindac|Eflornithine two 250 mg tablets PO daily for 3 years. Sulindac one 150 mg tablet PO daily for 3 years.
16205686|NCT01349868|Drug|PT005 MDI|PT005 MDI taken as two inhalations
16205687|NCT01349868|Drug|Formoterol Fumarate 12 μg (Foradil® Aerolizer®)|Taken as 1 capsule. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece
16205688|NCT01349868|Drug|Formoterol Fumarate 24 μg (Foradil® Aerolizer®)|Taken as 2 capsules. Each capsule contains 12 μg corresponding to 10 µg formoterol fumarate dihydrate delivered from the mouthpiece
16205689|NCT01349868|Other|Placebo MDI|Matching placebo to PT005 MDI taken as two inhalations
16205690|NCT01349855|Drug|Insulin glargine HOE901|Pharmaceutical form:solution for injection: new formulation and marketed formulation Route of administration: subcutaneous
16205691|NCT01349842|Biological|Blood sampling|20ml of patient peripherical blood will be collected
16205692|NCT01349842|Other|Usual clinical and radiological criteria|Clinical examination, tumoral evaluation
16205693|NCT01349829|Biological|HAVpur Junior|"≥12 International Units (IU) hepatitis A antigen coupled to virosomes, intramuscularly (i.m.), anterolateral thigh (M. vastus lateralis) or deltoid (M. deltoideus)
~Vaccination schedule: single doses at 0 and 6 months"
16205694|NCT01349829|Biological|Havrix 720 Junior|"≥720 ELISA Units (EU) hepatitis A antigen adsorbed to aluminium hydroxide, intramuscularly (i.m.), anterolateral thigh (M. vastus lateralis) or deltoid (M. deltoideus)
~Vaccination schedule: single doses at 0 and 6 months"
16205695|NCT01349816|Drug|PT003|PT003 MDI administered as two puffs BID for 7 days
16205696|NCT01349816|Drug|PT001|PT001 MDI administered as two puffs BID for 7 days
16205697|NCT01349816|Drug|PT005|PT005 MDI administered as two puffs BID for 7 days
16205698|NCT01349803|Drug|PT005 MDI|PT005 MDI administered as two puffs BID for 14 days
16205699|NCT01349803|Drug|PT001 MDI|PT001 MDI administered as two puffs BID for 14 days
16205700|NCT01349803|Drug|PT003 MDI|PT003 MDI administered as two puffs BID for 14 days
16206189|NCT01345812|Drug|recombinant FSH|100 -300 IU for stimulation of women in ART treatment
16205702|NCT01349790|Drug|NewGam|NewGam is a solution of human normal immunoglobulin 10% treated with solvent/detergent and nanofiltered for intravenous administration.
16205703|NCT01349777|Drug|Pregrel®|Pregrel® 75mg daily for 12 months
16205704|NCT01349777|Drug|Plavix®|Plavix® 75mg daily for 12 months
16205705|NCT01349764|Drug|Vitamin D3|
16205706|NCT01349751|Drug|isobaric levobupivacaine|0.42% either isobaric levobupivacaine 3 ml spinal injection once
16205707|NCT01349751|Drug|hyperbaric levobupivacaine|0.42% hyperbaric levobupivacaine 3 ml spinal injection once
16205708|NCT01349738|Drug|Antibiotic|Antibiotic (drug) sensitive to most recent culture for these subjects testing ASB positive and also experience Signs and symptoms of a UTI
16205709|NCT01349725|Drug|ARRY-502|Oral; multiple dose, escalating
16205710|NCT01349725|Drug|Placebo|Oral; matching placebo
16205711|NCT01349699|Drug|iron sucrose|1.25 mg/kg iron sucrose is administered intravenously 1 hr before endotoxin administration
16205712|NCT01349699|Drug|Deferasirox|30 mg/kg deferasirox is administered orally 2 hrs before endotoxin administration.
16205713|NCT01349699|Drug|endotoxin|at t=0 2ng/kg purified E.Coli endotoxin is administered intravenously
16205714|NCT01349699|Drug|Placebo|"At t=-2 hrs starch is dissolved in water to serve as a placebo for exjade. It is prepared and administered orally by a research nurse that is unblinded to the protocol.
~At t=-1 hrs 0.9% NaCl is administered intravenously serving as a placebo for iron sucrose. The infused volume is identical, and the syringes en tubes are blinded by aluminum foil. The administration is carried out by a research nurse that is unblinded to the protocol."
16205715|NCT01349686|Procedure|Diet|Oral intake of fluids during labour, from admission (dose: two cups of 8 ounces each of clear tea with little sugar).
16205716|NCT01349686|Procedure|Fasting|No intake of fluids during labour.
16205717|NCT01349673|Drug|Budesonide Foam|Topical
16205718|NCT01349660|Drug|Bevacizumab|Bevacizumab 10 mg/kg IV every 2 weeks
16205719|NCT01349660|Drug|BKM120|BKM120 orally (PO) once daily
16205720|NCT01349647|Biological|vaccine comprised of KLH conjugates of GD2L, GD3L, Globo H, fucosyl GM1, and N-propionylated polysialic acid plus OPT-821 adjuvant|Patients will be vaccinated with the pentavalent vaccine comprised of KLH conjugates of GD2L, GD3L, Globo H, fucosyl GM1, and N-propionylated polysialic acid plus OPT-821 adjuvant. Patients will receive vaccine at weeks 1, 2, 3, 9, 20, and 32. Patients will also receive one cycle of chemotherapy with etoposide and cisplatin or carboplatin at week 6.
16205721|NCT01349647|Biological|Biological/Vaccine: vaccine comprised of KLH conjugates of GD2L, GD3L, Globo H, fucosyl GM1, and N-propionylated polysialic acid plus OPT-821 adjuvant|"Patients will be vaccinated with the pentavalent vaccine comprised of KLH conjugates of GD2L, GD3L, Globo H, fucosyl GM1, and N-propionylated polysialic acid plus OPT-821 adjuvant.
~Patients will receive vaccine at weeks 1, 2, 3, 4, 8, and 16."
16205722|NCT01349634|Other|Iodized salt|salt for human consumption is fortified at the national level with iodine. The experimental group will receive iodized salt early. the comparison group will receive it by market forces. presently there is only enough iodized salt to meet 10% of the countries needs, and is targeted mainly to urban areas.
16205723|NCT01349608|Behavioral|Telephonic health coaching|Participants will be given a pedometer and activity log to use daily to track their physical activity accomplishments. Weekly, they will participate in a health coaching telephone session to discuss physical activity and set goals. The health coach is knowledgable in COPD care and will utilize a motivational interviewing approach to support the self-efficacy of the participants to be more active.
16205724|NCT01349595|Drug|Bortezomib|"Patients randomized to bortezomib treatment will receive 2, 4-dose cycles of drug followed by a 2 month hiatus. At the end of this time, subjects will be re-evaluated for the appropriateness of receiving a 3rd and 4th cycle of bortezomib. Bortezomib will be given subcutaneously (under the skin). If unable to give subcutaneously, bortezomib will be given as a single IV (injection into vein) over a time of 3 to 5 seconds. Patients will receive up to 4, four-dose cycles of 1.3 mg/m(2) (based on body surface area)."
16205725|NCT01349582|Procedure|flow diversion|endovascular treatment with flow diversion including standard management of thrombo-embolic risk
16205726|NCT01349582|Other|conservative management|conservative management is watchful observation of the aneurysm until indication for intervention arises
16205727|NCT01349582|Procedure|endovascular coiling|standard endovascular coiling of aneurysm with any type of already approved coil. High porosity stents may be used as an adjunct technique to coiling
16205728|NCT01349582|Procedure|balloon parent vessel occlusion|sacrifice of parent artery of aneurysm by endovascular balloon occlusion with or without bypass
16205729|NCT01349582|Procedure|surgical clipping|clipping of the aneurysm following invasive brain surgery
16205730|NCT01349569|Drug|Lenalidomide|Dosage forms: 5, 10, 15 and 25 mg capsules. Patients will be continued on the same dose of lenalidomide as they were prior to being enrolled in the study. Doses of lenalidomide for investigation can vary from 5- 25 mg/day, orally on days 1 - 21 followed by 7 days rest (28 day cycle).
16205731|NCT01349569|Biological|Allogeneic Myeloma Vaccine|A total of 4 vaccines will be administered. The first three at monthly intervals and a booster at 6 months from the initial vaccine. Each vaccination will consist of five total intra-dermal injections, two each in the right and left anterior upper thighs, and one in the non-dominant upper arm (unless contraindicated). Each dose will be administered on an outpatient basis. The subject must be observed in the clinic for at least 30 minutes after vaccination is completed.
16205732|NCT01349569|Biological|Prevnar-13|Prevnar-13 will be administered at 0.5ml dose by intramuscular injection at the same time as GVAX vaccine.
16205733|NCT01349556|Drug|Tretinoin|tretinoin 0.025% cream
16205734|NCT01349543|Biological|RSV A Memphis 37|Intranasal administration
16205735|NCT01349530|Other|Evaluating of usual care|RESEARCH IN CURRENT CARE
16205736|NCT01349530|Other|Evaluation of CREATIF|RESEARCH IN CURRENT CARE
16205737|NCT01349517|Procedure|MIE|The patients in this group would perform minimal invasive three-incision subtotal esophagectomy (thoracoscopic and/or laparoscopic)
16205738|NCT01349517|Procedure|Three-incision thoracotomy|The patients in this group would perform three-incision subtotal esophagectomy (thoracotomy and laparotomy)
16205739|NCT01349517|Procedure|Ivor-Lewis esophagectomy|The patients in this group would underwent Ivor-Lewis esophagectomy
16205740|NCT01349517|Procedure|Sweet esophagectomy|The patients in this group would underwent Sweet esophagectomy.
16205741|NCT01349491|Drug|Ranolazine|Patients will be started on ranolazine 500mg twice daily. The first dose will be administered the day of cardioversion. The dose will be doubled after 2 weeks to 1000mg twice daily as tolerated for a total of six months.
16205742|NCT01349491|Drug|Matching placebo|Patients will be started on a matching placebo twice daily. The first dose will be administered the day of cardioversion and continued for a total of six months.
16205743|NCT01349478|Device|LOKOMAT|Robot-assisted gait training,8 weeks,3 sessions a week,20-45 min each session.
16205744|NCT01349465|Drug|No treatment|No treatment was given to patients during this study as this is a follow-up study of previous Phase IIb or Phase III in which they received a TMC435-containing regimen.
16205745|NCT01349452|Drug|Ganciclovir|Ganciclovir 0.15% Ophthalmic gel
16205746|NCT01349452|Drug|Artificial tear|Artificial tear 5 times per day
16205747|NCT01349439|Drug|Propranolol|1mg per Kg (participant weight)
16205748|NCT01349439|Drug|Short acting + long acting propranolol + memory reactivation|After completing the double-blind phase of the study, participants will receive short acting propranolol 1mg/kg (patient weight) + long acting propranolol (1 or 1.5 mg/kg) followed by memory reactivation. Dose level for the long-acting propranolol will be randomly assigned across participants.
16205749|NCT01349426|Device|LigaSure Force Triad Vessel Sealing System|Quality of parenchymal pneumostasis comparison after fissure closure: LigaSure vs automatic staplers
16205750|NCT01349413|Drug|Esomeprazole 20mg|Oral Esomeprazole 20mg daily for 8 weeks
16205751|NCT01349413|Other|Placebo|Identical looking placebo
16205752|NCT01349400|Other|Watchful waiting|Watchful waiting means the observation of the hernia. The patient is informed about signs of deterioration or incarceration. The hernia is controlled clinically on defined follow-up visits.
16205753|NCT01349400|Procedure|Hernia repair|"Open or laparoscopic hernia repair with mesh (non-absorbable or partly-absorbable alloplastic material) or with direct suture repair. For hernias measuring ≥ 3 cm mesh repair is recommended. A wide overlap of the mesh over the fascia margin on each side has to be provided.
~These are all standard techniques in incisional hernia repair."
16205754|NCT01349387|Drug|Metformin|After inclusion in the study to J0, metformin treatment will be interrupted between J1 and J30, replaced by Januvia 100 mg/day dose, then resumed at J31.
16205755|NCT01349374|Other|skin biopsy|Obtention of skin micro-samples collected from healthy volunteers and diabetic patients (type 2 and MODY), intended to be used afterwards to obtain stem cell lines, in the framework of new therapeutic strategies of type 2 diabetes.
16205756|NCT01349361|Procedure|Daylight mediated photodynamic therapy|
16205757|NCT01349348|Drug|Tolvaptan|tablet, 15 mg, Qd, for 7 days
16205758|NCT01349348|Drug|Tolvaptan|tablet, 7.5 mg, Qd, for 7 days
16205759|NCT01349348|Drug|placebo|tablet, 7.5/15mg , Qd, 7days.
16205760|NCT01349335|Drug|Tolvaptan|tablet, 15 mg, Qd, for 7 days
16205761|NCT01349335|Drug|Tolvaptan|tablet, 30 mg, Qd, 7 days
16205762|NCT01349335|Drug|placebo|tablet, 30 mg, Qd, 7days.
16205763|NCT01349322|Radiation|Whole breast irradiation delivered by 3-dimensional conformal radiation therapy or intensity modulated radiation therapy|Patients undergo whole breast radiotherapy by 3D-CRT or IMRT
16205764|NCT01349322|Radiation|Higher per daily radiation therapy|Patients undergo higher per daily radiation therapy
16205765|NCT01349322|Radiation|Concurrent boost radiotherapy|Patients undergo concurrent boost radiotherapy
16205766|NCT01349322|Radiation|Standard per daily radiation therapy|Patients undergo standard per daily radiation therapy
16205767|NCT01349322|Radiation|Sequential boost radiotherapy|Patients undergo sequential boost radiotherapy
16205768|NCT01349309|Behavioral|Swallowing Exercise Group|"Swallowing Exercises
~Perform each exercise 10 times. Do these 3 times a day. Vary the order of the exercises.
~Effortful Swallow: As you swallow squeeze hard with all your muscles. (Can do with water or without)
~Super Supraglottic Swallow:
~Inhale and hold your breath very tightly, bearing down. Keep holding your breath and bearing down as you swallow. Cough when you are finished. (Can do with water or without)
~Tongue Hold Maneuver:
~Gently hold your tongue in between your front teeth and swallow your saliva.
~Tongue Retraction:
~Pull the back of your tongue to the back of your mouth and hold.
~Mendelsohn Maneuver:
~Swallow your saliva and pay attention to your neck as you swallow. Try to feel that something (your Adam's apple of voice box) lifts and lowers as you swallow. Now, when you swallow and you feel something lift as you swallow don't let it drop. Hold it with your muscles for several seconds."
16205769|NCT01349296|Drug|Everolimus + BIBF 1120|Dose level 1: 1x 5mg Everolimus/d + 2x 150mg BIBF 1120/d. Dose level 2: 1x 5mg Everolimus/d + 2x 200mg BIBF 1120/d. Dose level 3: 1x 10mg Everolimus/d + 2x 200mg BIBF 1120/d
16205770|NCT01349283|Biological|HepavaxGene (thiomersal free)|10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6
16205771|NCT01349283|Biological|Engerix B|10 µg/0.5 mL, intramuscular injection on Day 1, Month 1, Month 6
16205772|NCT01349270|Drug|Immunoglobulin perfusion|patient who received monthly 2g/kg intravenous cure of immunoglobulin
16205773|NCT01349270|Drug|Prednisone|patient who received 0,8mg/kg/day of prednisone progressively tapered over 6 months
16205774|NCT01349257|Drug|BDP/Formoterol|One single day treatment of CHF 1535 100/6 NEXT DPI®: CHF 1535 dry powder for inhalation (fixed combination of beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg per actuation) administered via the NEXT DPI® dry powder inhaler with charcoal block.
16205775|NCT01349231|Drug|ketamine|Ketamine (a single 0.5mg intravenously over 40 minutes).
16205776|NCT01349218|Other|Blood sample drawn from a vein|0.5 ml will be drawn from a vein when an IV is started for the surgery or from an IV already in place. The blood will be placed into a heparinized, 1 ml syringe for venous blood gas analysis.
16205777|NCT01349218|Other|Blood sample drawn from a heel stick|A second blood sample, 0.3 ml will be drawn into a capillary pipette from a heel stick for capillary blood gas analysis.
16205778|NCT01349205|Drug|Caffeine and sodium Benzoate 10 mg/kg IV|IV, 10mg/kg, IVP, 1 time
16205779|NCT01349205|Drug|Caffeine and Sodium Benzoate 20 mg/kg IV|IV, 20 mg/kg, IVP, 1 time
16205780|NCT01349205|Drug|0.9 NS Saline|IV, 0-10 ml, IVP, 1 time
16205781|NCT01349192|Drug|Rifampin|Adult Dose: 300mg twice daily for 14 days. Pediatric Dose: <40kg : 15mg/kg daily for 14 days divided every 12 hours.
16205821|NCT01348971|Other|Sodium chloride|Preoperative oral administration of sodium chloride the night before surgery and three hours before surgery
16205782|NCT01349192|Drug|Trimethoprim/Sulfamethoxazole|Adult Dose: 320/1600 orally twice daily for 14 days. Pediatric Dose: <40 kg : 8mg/kg trimethoprim / 40 mg/kg sulfamethoxazole twice a day for 14 days.
16205783|NCT01349192|Drug|Minocycline|"only subjects greater or equal to 8 years of age, who are not able to tolerate TMP/SMX or whose screening MRSA is resistant to TMP/SMX should be prescribed minocycline.
~Adult dose: 100 mg orally twice daily for 14 days Pediatric dose: < 50 kg : 2mg/kg orally twice daily for 14 days not to exceed 200mg per day."
16205784|NCT01349192|Drug|Mupirocin|1 gram 2% nasal ointment generously applied to each nostril using a cotton swab twice daily for 14 days.
16205785|NCT01349192|Drug|chlorhexidine gluconate oral rinse|for subjects able to swish without swallowing. 0.12% chlorhexidine gluconate oral rinse twice daily for 14 days.
16205786|NCT01349192|Drug|2% Chlorhexidine solution wipes|whole body wash solution wipes once daily for first 5 days.
16205787|NCT01349192|Behavioral|Environmental Decontamination|"wipe down high touch surfaces and medical equipment with surface disinfecting wipes daily for the first 21 days.
~wash all linens and towels in hot water once weekly for three weeks."
16205788|NCT01349179|Device|Metal on metal hip arthroplasty operated on 2002|The purpose of the study is to evaluate the presence of geodes acetabular and femoral with scan examination.
16205789|NCT01349166|Behavioral|Behavior: Supervised physical training|protocol designed to evaluate effects of physical activity on cardiometabolic and inflammatory biomarkers according to glucose tolerance
16205790|NCT01349153|Behavioral|Facebook-based Messages/Website|Twelve weekly messages, a pedometer, sixteen group discussions, and access to an exercise website to promote increased physical activity.
16205791|NCT01349153|Behavioral|Facebook-based Self-help Comparison|Twelve weekly messages and a pedometer.
16205792|NCT01349140|Drug|SKY0402|Single-injection femoral nerve block. Initial doses of SKY0402 will begin at 0 mg, and 2 mg (high) for the first subject; and 1 mg (low) and 3 mg (high) for the second subject. The next doses will be between 0-80 mg per side, determined prior to randomization of each subsequent subject. The specific subsequent doses will increase, remain the same, or decrease, determined by the P.I. in consultation with the manufacturer of SKY0402. Doses will always remain within the range of 0-80 mg per side, for a total possible dose of 0-160 mg.
16205793|NCT01349127|Dietary Supplement|20µg Vitamin D3|20µg (800IU) of vitamin D3/day for 12-weeks while lactating, commencing 10-14 days post-partum.
16205794|NCT01349127|Dietary Supplement|20µg Vitamin D3 + 500 mg Calcium|20µg (800IU) of vitamin D3 + 500mg calcium carbonate/day for 12-weeks while lactating, commencing 10-14 days post-partum.
16205795|NCT01349127|Dietary Supplement|Placebo|One gelatin placebo capsule containing zero vitamin D3 taken for 12-weeks while lactating, commencing 10-14 days post-partum.
16205796|NCT01349114|Drug|aliskiren 300 mg once daily|aliskiren 300 mg daily
16205797|NCT01349114|Drug|Placebo/sugar pill|Sugar pill/placebo
16205798|NCT01349101|Radiation|Total Body Irradiation|"Myeloablative HSCT Arm: Total body irradiation (TBI) is given in 8 fractions over 4 days (total dose of 12 Gy)
~Reduced Intensity HSCT Arm: TBI is given in one fraction (total dose of 2 Gy)"
16205799|NCT01349101|Drug|Cyclophosphamide|Cyclophosphamide is administered on the third day after the hematopoietic stem cell transplantation (HSCT) to help reduce graft-versus-host disease (GVHD). It is given at a dose of 60 mg/kg/d for 2 days on days +3 and +4.
16205800|NCT01349101|Drug|Tacrolimus|Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
16205801|NCT01349101|Drug|Mycophenolate mofetil|Started the fifth day after the transplant to help prevent graft-versus-host disease (GVHD).
16205802|NCT01349101|Drug|Fludarabine|Started the fifth day before the transplant. Given for four days at 30 mg/m2/d.
16205803|NCT01349101|Drug|Busulfan|Started the fourth day before the transplant. Given for two days at 3.2 mg/kg.
16205804|NCT01349101|Genetic|Hematopoietic stem cell transplantation|Allogeneic marrow transplantation given after the last dose of total body irradiation (TBI)
16205805|NCT01349088|Drug|Ixabepilone|Patients will receive ixabepilone at 40 mg/m2.
16205806|NCT01349088|Drug|Capecitabine|Patients will receive capecitabine at 2000 mg/m2.
16205807|NCT01349088|Drug|Motesanib|Patient will receive motesanib at 100mg or 125mg once daily dependent on outcome of Phase I, which will involve the first 3-6 patients.
16205808|NCT01349075|Radiation|TheraSphere|The target dose of TheraSphere most commonly used is 120 - 140 Gy. Standard radiation safety techniques will be used.
16205809|NCT01349062|Drug|"Kallunk oxide (Immunotherapy) "|"The study is assigned Arm 1 above 450 cu/mm^3 baseline CD + T cells. HIV type-1 subjects will receive one drug, a daily regimen of Kallunk oxide(Immunotherapy) + Long Pepper, that is a combination of a traditional alternative medicine (Complementary and Alternative Medicine CAM) as Kallunk oxide and appropriate drug carrier antidote. The drug assigns to 5 mg Kallunk oxide molecules with1995 mg Antidote( This antidote was used as a carrier of Kallunk oxide molecules), respectively, for children and adults. Dosage: 2000 mg for children and adults. This powder form sample size product will be administered once daily dose on 7 days treatment. The Botanical name of the antidote is Piper Longum."
16205810|NCT01349049|Drug|PLX3397|Maximum Tolerated Dose of PLX3397 will be administered orally, twice daily.
16205811|NCT01349049|Drug|PLX3397|The drug product is available in capsule form, to be taken orally.
16205812|NCT01349036|Drug|PLX3397|Capsules administered once or twice daily, continuous dosing
16205813|NCT01349023|Other|Energy density (ED), Energy content|Standard or reduced energy content and energy density of pre-portioned entrees
16205814|NCT01349010|Drug|Probucol|250mg (1 tablet) bid. p.o for 8 weeks
16205815|NCT01349010|Drug|Placebo|1 tablet bid. p.o for 8 weeks
16205816|NCT01348997|Behavioral|Project Onward website + 16 person social network|The website will include 8 weeks of Internet-based cognitive behavioral therapy combined with discussion and support from a group of up to 16 other cancer survivors.
16205817|NCT01348997|Behavioral|Project Onward website + 8 person social network|The website will include 8 weeks of Internet-based cognitive behavioral therapy combined with discussion and support from a group of up to 8 other cancer survivors.
16205818|NCT01348984|Drug|transdermal fentanyl patch|TFP = transdermal fentanyl patch (50 microgram/hour)
16205819|NCT01348984|Drug|placebo patch|group 2 = placebo patch
16205820|NCT01348971|Dietary Supplement|Sodium nitrate|Preoperative oral administration of sodium nitrate. 700 mg the night before surgery and 700 mg three hours before surgery
16205822|NCT01348958|Device|iDXA knee software|"Following surgery, subjects who have undergone knee arthroplasty will have the knee that has undergone arthroplasty (post-operative) scanned at least 8 weeks after surgery.
~During one visit, each subject will have the post-operative knee scanned 1 time using Lunar orthopedic application, and 3 times with the subject repositioned between scans using the Lunar orthopedic knee application (total of 4 scans). Lunar iDXA measurement procedures will be done"
16205823|NCT01348945|Other|conventional ACL rehabilitation program|Conventional post-operative physical therapy exercises and rehabilitation, designed for ACL reconstruction for 6 months to 9 months.
16205824|NCT01348919|Drug|CEP-18770|administered on days 1, 8, and 15 of each 28-day cycle
16205825|NCT01348919|Drug|Lenalidomide|administered 25 mg on days 1 through 21 of each 28-day cycle
16205826|NCT01348919|Drug|Dexamethasone|administered 40 mg on days 1, 8, 15, and 22 of each 28-day cycle
16205827|NCT01348906|Procedure|intermittent normoxia|3 cycles of 5/5 min normoxia/hyperoxic reperfusion during cardioplegia arrest in adult valve replacement
16205828|NCT01348893|Behavioral|Yoga|12 to 16 weeks of group yoga classes (approximately 32 classes per student), 30-45 minutes per class, 2-3 times per week, during physical education class. Yoga program includes physical postures and movement, breathing exercises, partner/group games, deep relaxation and meditative techniques.
16205829|NCT01348880|Drug|Vardenafil ODT, (Staxyn, BAY38-9456)|Single dose of 10 mg of vardenafil ODT, taken without water
16205830|NCT01348880|Drug|Placebo|Single dose of placebo to match 10 mg vardenafil ODT. taken without water
16205831|NCT01348867|Other|Structured care led by a nurse consultant|"For the intervention group, patients will be followed up according to the following protocol. The structured care team consists of:
~i) Diabetes Nurse Consultant to reinforce compliance; educate patients on insulin injection techniques and reinforce self-care including self blood glucose monitoring and lifestyle interventions, titration of medication.
~ii) Technical Service Assistance to remind patients to take medications and/or give insulin injection, monitor blood glucose as prescribed, attend their next clinic appointment, encourage patients to report all side effects, self initiated change in regimen or concerns to diabetes nurse consultant and/or their doctors at the next follow up visit."
16205832|NCT01348854|Device|iFS Femtosecond Laser System|arcuate incisions placed with the iFS femtosecond laser
16205833|NCT01348841|Other|Systematic referral to MDWCT and comprehensive primary care|Systematic referral to, and follow up, by Multi-Disciplinary Wound Care Teams (MDWCTs), co-ordinated by the Case Manager (CM), will occur.There will be immediate referral to the MDWCT of clients with :1/ diabetic lower extremity ulcers,2/peripheral neuropathy, charcot changes,3/wound present longer than 4 mths. ,4/ Ankle Brachial Index less than 0.6, non-diabetics, and not being seen by a vascular surgeon. Subsequent referral to MDWCT will occur if less than 30% healing by week 4.
16205834|NCT01348828|Device|Endovascular Aortic Aneurysm Repair (Endologix Fenestrated Stent Graft System)|Endovascular repair of juxtarenal or pararenal aortic aneurysm using the Endologix Fenestrated Stent Graft System
16205835|NCT01348802|Behavioral|Push + Pull|Push + Pull is evidence on pain that is extracted from medical, nursing, psychology and rehabilitation journals, appraised for quality and relevance, and delivered to clinicians by e-mail alerts or available for searches of the accumulated database.
16205836|NCT01348802|Behavioral|Pull|Pull will be an intervention with a similar front-face but requires clinicians to go to the site and extract evidence from an electronic database.
16205837|NCT01348789|Device|Hair2Go (Mē)|Treatment with Hair2Go (Mē) three times every 2-4 days
16205838|NCT01348776|Device|Hair2Go (Mē)|Treatment with Hair2Go Device 7 times every week with maintenance treatments once a month for 3 months
16205839|NCT01348763|Drug|Maraviroc|Maraviroc 150 mg daily
16205840|NCT01348763|Drug|Truvada|daily until 10. day then stop
16205841|NCT01348763|Drug|Darunavir|daily until 10. day then stop
16205842|NCT01348750|Other|Healing Touch & Guided Imagery|"Healing Touch (HT) is an energy based approach to health and healing. It uses light touch to influence the energy field that surrounds the body, and the energy centers which control the flow of energy to the physical body.
~HT complements traditional health care and is used together with other approaches to health and healing.
~Guided Imagery (GI) is a form of focused relaxation used to create harmony between the mind and body. Positive mental imagery can promote relaxation, reduce stress and improve mood as well as alter heart rate, blood pressure and breathing."
16205843|NCT01348737|Drug|AZD3839|Single Oral Dose
16205844|NCT01348737|Drug|AZD3839 Placebo|Single Oral Dose
16205845|NCT01348724|Drug|[14C] NKTR-118|Single 25 mg oral dose administered on Day 1
16205846|NCT01348698|Procedure|Tumor tissue biopsy|Participants whose tumor does not secrete hormones will have a tumor biopsy to collect tissue for the study.
16205847|NCT01348698|Procedure|Surgery|Participants who have a large tumor or one that secretes hormones will have standard surgery to remove the tumor. Tissue will be collected for study.
16205848|NCT01348685|Other|Compare the effect of solid vs. liquid forms of sugars on satiety and food intake|
16205849|NCT01348685|Other|the effect of solid vs. liquid forms of gelatin on appetite and food intake|
16205850|NCT01348685|Other|The effect of solid vs. liquid forms of whey protein on food intake|
16205851|NCT01348659|Drug|7.2% NaCl/hydroxyethylstarch|250 ml of 7.2% NaCl in hydroxyethylstarch (HES 200/0,5) will be given into the venous reservoir of the cardiopulmonary bypass circuit after aortic declamping.
16205852|NCT01348659|Drug|NaCl 0.9%|250 ml of NaCl 0.9% will be given into the venous reservoir of the CPB circuit after aortic declamping.
16205853|NCT01348646|Behavioral|Brief intervention|The adolescents were shown a series of photographs of discoloured teeth caused by smoking. Then a mirror was given to the adolescent to let him/her see if similar stains could be seen on his/her teeth. Non-smoking adolescents also received positive feedback for being non-smokers. Duration of a single brief intervention was 2-3 minutes.
16205854|NCT01348620|Device|Single port laparoscopic cholecystectomy SINGLE SITE LAPAROSCOPY ACCESS SYSTEM (Johnson & Johnson Medical Spa)|Single port laparoscopic cholecystectomy. SINGLE SITE LAPAROSCOPY ACCESS SYSTEM (Johnson & Johnson Medical Spa)
16205855|NCT01348620|Procedure|Four port laparoscopic cholecystectomy surgery|Four port laparoscopic cholecystectomy surgery
16205856|NCT01348607|Drug|methylphenidate hydrochloride|Given orally
16205857|NCT01348607|Drug|modafinil|Given orally
16205858|NCT01348607|Drug|placebo|Given orally
16206190|NCT01345799|Drug|TRK-170|
16205859|NCT01348581|Device|Marigen Wound Dressing|The dressing is changed at least twice a week, with no more than five days between dressing changes. It is extremely important that the dressings are changed sufficiently often. On highly exuding ulcers the three or four dressing changes per week may be necessary. Duration is four weeks.
16205860|NCT01348568|Dietary Supplement|low glycemic index diet with canola oil bread|
16205861|NCT01348568|Dietary Supplement|High fiber diet|
16205862|NCT01348555|Drug|Bronchodilatator|
16205863|NCT01348555|Drug|Bronchodilatator|
16205864|NCT01348542|Drug|Trazodone|50 mg once a day, for 3 months
16205865|NCT01348542|Behavioral|Cognitive Behavioral Therapy|The CBT Protocol is implemented over a period of 12 weeks, with 4 consultations held on a weekly basis and 4 held on a biweekly basis.
16205866|NCT01348529|Behavioral|Internet CBT|Internet-delivered cognitive behavioral therapy with therapist support.
16205867|NCT01348516|Drug|KM-023|-KM-023 is dosed orally via 75 mg tablets. Study doses are 75 mg, 150 mg, 300 mg, and 600 mg QD for 1 (SAD) or 7 (MAD) days.
16205868|NCT01348516|Drug|Placebo for KM-023|-Placebo for KM-023 is dosed orally via Placebo for KM-023 tablets. Study doses are 1, 2, 3, and 4 placebo tablets QD for 1 (SAD) or 7 (MAD) days.
16205869|NCT01348503|Drug|Lenalidomide|Escalating doses starting at 15 mg by mouth per day.
16205870|NCT01348503|Drug|Sorafenib|Fixed dose of 400 mg by mouth twice a day.
16205871|NCT01348490|Drug|Ruxolitinib|Ruxolitinib (INCB018424), 5 mg bid
16205872|NCT01348477|Procedure|Elliptical domed mesh technique|A segment of polypropylene mesh of 10 by 15cm enters the inguinal preperitoneal space, where takes the form of a dome and is fixed by four stitches
16205873|NCT01348464|Procedure|single port appendectomy, three port appendectomy|visual analog scale. questionnaire on wound satisfaction
16205874|NCT01348451|Device|surgical implantation|human spinal cord stem cell implantation in ALS patients
16205875|NCT01348438|Device|Medtronic Engager Transcatheter Aortic Valve Implantation System|Transapical implantation of the Medtronic Engager Transcatheter Aortic Valve Implantation System
16205876|NCT01348425|Device|Longer Zilver PTX Stents|Treatment with at least one 100 mm or longer Zilver PTX stent
16205877|NCT01348425|Device|Shorter Zilver PTX Stents|Treatment with Zilver PTX stents 80 mm or shorter only
16205878|NCT01348412|Drug|oxaliplatin|130 mg/m²Every 21 days
16205879|NCT01348412|Drug|raltitrexed|3 mg/m² with a maximum of 6 mg every 21 days
16205880|NCT01348412|Drug|other intravenous chemotherapy drugs|
16205881|NCT01348386|Drug|Hydroxide Potassium|Treatment will consist of the application of topical 10% or 15% KOH in an aqueous solution for the two treatment groups, compared to a placebo-treated control group. Topical Application.
16205882|NCT01348386|Drug|Placebo|
16205883|NCT01348347|Drug|Volasertib, low dose, d1q3w|Patient to receive low dose of Volasertib IV
16205884|NCT01348347|Drug|Volasertib, middle dose, d1q3w|Patient to receive middle dose of Volasertib IV
16205885|NCT01348347|Drug|Volasertib, high dose, d1q3w|Patient to receive high dose of Volasertib IV
16205886|NCT01348334|Procedure|Synthetic sling surgery|An incision of inverted A shape was inflicted on the anterior vaginal wall(AVW)of the vagina.The upper part of A shaped incision was formed into an island belonging to the vaginal wall.This patch was 3×4cm in most of the patients.Proximal AVWwas dissected as a flap.Synthetics mesh materials were first sutured onto the upper part of the A on the vaginal island with absorbable vicrly sutures.Then,with 2polypropilen sutures,these meshes were fixed on both the right and left sides of this island in a helical manner to form a suspension and using curved Kishner needles,the prolene sutures were transferred to suprapubic area.These sutures were ligated on the rectus fascia in a crosswise manner.The mobile lower wing was advanced onto the island and was sutured onto the vaginal skin with intermittent sutures using 3-0 monocryl sutures.After cystoscopy,the prolene sutures were ligated crosswise in the suprapubic region.Special attention was paid notto create much tension on the mesh material.
16205887|NCT01348321|Drug|Levamisole|Group 1: Azithromycin 500 mg per day, three days a week plus oral levamisole 150 mg per day, two days a week. Group 2: Azithromycin 500 mg per day, three days a week. The used medications were not revealed to their physician. A questionnaire was filled for every patient and photos were taken from lesions using a digital camera at first, second and final visit.
16205888|NCT01348308|Drug|Maraviroc (Celsentri)|"Patients will take cART optimized regimen according to the recommended regimen as first line of treatment in most commonly used guidelines with Maraviroc at the following dose: 150 mg orally twice a day for patients receiving a Protease Inhibitor Ritonavir-boosted regimen (except Fosamprenavir), 300 mg orally twice a day for patients receiving a Fosamprenavir Ritonavir-boosted regimen or 600 mg orally twice a day for patients receiving Efavirenz-based regimen.
~Duration: 72 weeks."
16205889|NCT01348308|Drug|Placebo|"Patients will take cART optimized regimen according to the recommended regimen as first line of treatment in most commonly used guidelines with Placebo at the following dose: 150 mg orally twice a day for patients receiving a Protease Inhibitor Ritonavir-boosted regimen (except Fosamprenavir), 300 mg orally twice a day for patients receiving a Fosamprenavir Ritonavir-boosted regimen or 600 mg orally twice a day for patients receiving Efavirenz-based regimen.
~Duration: 72 weeks."
16205890|NCT01348295|Other|Observation|No interventions are made. The purpose of the study is to find out current practices used in pediatric mechanical ventilation.
16205891|NCT01348282|Drug|Lithium|lithium, in tablets, beginning a 2-daily 400 mg dose, and changing further adjusting the dose according to drug levels in serum.
16205892|NCT01348282|Drug|Rivastigmine|rivastigmine, in transdermal patch administration, beginning a once-daily 4.6 mg dose, and changing further increasing the dose up to once-daily 9.5 mg.
16205893|NCT01348269|Drug|Aclasta|1 x intravenous non-current drip (infusion)
16205894|NCT01348269|Drug|Placebo|NaCl Solution
16205895|NCT01348256|Drug|Dendritic cells vaccine|Vaccination with autologous dendritic cells loaded with autologous tumor antigens
16205896|NCT01348243|Drug|disodium clodronate 200 mg/4 ml with 1% lidocaine|CLODRONATE 200 MG/4 ML SOLUTION FOR INTRAMUSCULAR USE WITH 1% LIDOCAINE EVERY OTHER WEEK
16205897|NCT01348243|Drug|Disodium clodronate 100 mg/3,3 ml with 1% lidocaine|CLODRONATE 100 MG/3,3 ML SOLUTION FOR INTRAMUSCULAR USE WITH 1% LIDOCAINE ONCE-WEEK
16205898|NCT01348230|Other|Urine samples|collect their first morning urine samples before each of their remaining prenatal care appointments for our studies
16206191|NCT01345799|Drug|Placebo|
16205899|NCT01348217|Radiation|"Conformal 3D Radiotherapy with  ENI -type prophylactic irradiation of the lymph node"|40 Gy in 20 fractions / 5 weeks, PTV (1cm in every direction)
16205900|NCT01348217|Radiation|Boost|Boost 10 Gy in 5 fr, PTV = +1cm.
16205901|NCT01348217|Radiation|Boost|Boost 26 Gy in 13 fr, PTV = +1cm.
16205902|NCT01348217|Drug|chemotherapy: FOLFOX 4|6 treatments with 4 courses concomitant to radiotherapy (D1, D15, D29, D43) arm B or 3 courses concomitant to radiotherapy (D1, D15, D29) arm A.
16205903|NCT01348204|Other|quercetin|health food supplement
16205904|NCT01348191|Procedure|Myometrial biopsy|At caesarean section, after birth of the baby but before closure of the uterus, a biopsy from the upper lip of the incision in the lower uterine segment will be taken. This biopsy will measure approximately 2x50mm.
16205905|NCT01348178|Procedure|Follow-up|Follow-up
16205906|NCT01348165|Drug|BI 137882|Powder for oral solution
16205907|NCT01348165|Drug|Placebo|Powder for oral solution
16205908|NCT01348152|Drug|DAIKENCHUTO (TU-100)|Subjects will be randomized to 15 g/day of TU-100. Dosage is granule. Subjects will ingest two 2.5 g doses of TU-100 three times daily for 34 consecutive days.
16205909|NCT01348152|Drug|Placebo|Subjects will be randomized to 15 g/day of placebo. Dosage is granule. Subjects will ingest two 2.5 g doses of placebo three times daily for 34 consecutive days.
16205910|NCT01348139|Drug|AZD3199|Inhaled via single inhaler device (SID)
16205911|NCT01348139|Drug|AZD3199|Inhaled via Turbuhaler inhaler
16205912|NCT01348139|Other|AZD3199 Placebo|Inhaled via Turbuhaler inhaler and SID
16205913|NCT01348126|Drug|Docetaxel|75 mg/m2 administered on Day 1 of a 3-week treatment cycle by 1-hour intravenous infusion
16205914|NCT01348126|Drug|Combination of ganetespib and docetaxel|Ganetespib 150 mg/m2 in combination with docetaxel 75 mg/m2. On Day 1 of each 3-week treatment cycle, ganetespib and docetaxel will be administered as separate 1-hour intravenous infusions. Ganetespib 150 mg/m2 will be administered again on Day 15 of each cycle.
16205915|NCT01348113|Other|Brief Alcohol intervention|Brief intervention consists typically in a brief assessment, giving patients personal feedback, dealing with resistance and ambivalence, establishing a goal of reduced alcohol use, and giving a workbook; reinforcement visits or calls are included.
16205916|NCT01348100|Drug|Iloperidone crystalline formulation|Iloperidone was formulated as 100 µm crystals for IM depot injection.
16205917|NCT01348100|Drug|Iloperidone microparticle formulation|Iloperidone was formulated as microparticles for IM depot injection.
16205918|NCT01348100|Drug|Oral iloperidone|Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone to stable doses of 12 to 24 mg daily. In Phase A, oral iloperidone dosing lasted for at least 7 days and, in Phases B and C, for at least 10 to 14 days.
16205919|NCT01348087|Drug|AFQ056|The investigational drug, AFQ056, will be provided as hard gelatin capsules. Two different oral dosage strengths, identical in appearance, will be used.
16205920|NCT01348074|Drug|Double dose|For each individual the dose on Day 1 and Day 2 will be twice the one normally taken
16205921|NCT01348048|Other|Specialised palliative care (SPC)|The interventions given by the SPC centres follow the the WHO and the EAPC guidelines for palliative care. It is not possible in advance to describe the interventions more specifically as these will be adjusted to each particular patient. As part of the study the medical records of all patients in the intervention group will be reviewed with the purpose of describing the interventions given for the different symptoms and problems.
16205922|NCT01348009|Drug|Tesetaxel-capecitabine-cisplatin|"Phase 1: Tesetaxel orally on Day 1 of each cycle at dose of 18, 21, 24, or 27 mg/m2. If no dose-limiting toxicity, at least 3 subjects will be treated at each dose level until the maximum tolerated dose or the maximum dose of 27 mg/m2 is reached. At each tesetaxel dose level, capecitabine orally at a dose of 2000 mg/m2/day (administered in 2 equally divided doses) on Day 1-Day 14 and cisplatin intravenously at a dose of 60 mg/m2 on Day 1.
~Phase 2: Tesetaxel orally on Day 1 of each cycle at dose determined in Phase 1. Capecitabine orally at a dose of 2000 mg/m2/day (administered in 2 equally divided doses) on Day 1-Day 14 and cisplatin intravenously at a dose of 60 mg/m2 on Day 1."
16205923|NCT01347996|Drug|histamine dihydrochloride and IL-2|Ceplene 0.5 mg subcutaneously twice daily and IL-2 1 µg/kg [16,400 IU/kg] body weight twice daily for 10, 21 day cycles
16205924|NCT01347983|Drug|Tocilizumab+Methotrexate(MTX)|Tocilizumab: 8 mg/kg every 4 weeks, IV infusion Methotrexate: 10-20 mg/week
16205925|NCT01347970|Drug|carvedilol|Given PO
16205926|NCT01347970|Other|placebo|Given PO
16205927|NCT01347970|Other|pharmacogenomic studies|Correlative studies
16205928|NCT01347970|Other|laboratory biomarker analysis|Correlative studies
16205929|NCT01347970|Procedure|quality-of-life assessment|Ancillary studies
16205930|NCT01347970|Genetic|polymorphism analysis|Correlative studies
16205931|NCT01347970|Genetic|microarray analysis|Correlative studies
16205932|NCT01347970|Genetic|polymerase chain reaction|Correlative studies
16205933|NCT01347970|Other|enzyme-linked immunosorbent assay|Correlative studies
16205934|NCT01347970|Other|questionnaire administration|Ancillary studies
16205935|NCT01347957|Other|Nitric Oxide (NO) Gel|Nitric Oxide (NO) Gel is created by premixing of contents from 2 separate gel bottles. The first bottle, NO gel, is a solution of sodium nitrite (14.6mM) in distilled water with hydroxyethylcellulose (molecular weight 50,000-1,250,000) added for gel formation. The second bottle, Releasing-stimulator gel, is a solution of maleic acid (14.6mM) and ascorbic acid (14.6mM) in distilled water with hydroxyethylcellulose added for gel formation.
16205936|NCT01347957|Other|Placebo gel|The placebo gel is created by premixing of contents from 2 separate gel bottles. The first bottle is phosphate-buffered saline. The second bottle is the second gel bottle (Releasing-stimulator gel) as described in experimental arm.
16205937|NCT01347944|Drug|lenalidomide|Patients who were prescribed Revlimid from 31October 2008 to present.
16205938|NCT01347931|Device|NIOV System|Each subject's standard oxygen therapy will be used as the control treatment and compared to the test ventilator (NIOV) system during selected activities of daily living.
16205939|NCT01347931|Device|Standard Oxygen Cannula|Supplemental oxygen via a standard oxygen cannula connected to a portable oxygen cylinder
16205940|NCT01347918|Device|19F capsule|Two 19F capsules, one filled with hexafluorobenzene (HFB) and the other filled with perfluoro-15-crown-5-ether (PCE) will be administered orally together with 100 ml of water.
16205942|NCT01347905|Other|Stable-isotope techniques|Iron absorption will be estimated using stable-isotope techniques where incorporation of 57Fe and 58Fe into erythrocytes is measured 14 days after administration. The subjects will provide an initial blood sample (20ml) and then receive a test drink, containing 6 mg of 57Fe labeled ferrous sulphate. One hour later, 2 ml of an aqueous solution containing 100 μg 58Fe, as iron citrate in 250cc of normal saline will be infused over 50 min. Post infusion a 4ml blood sample will be taken. This procedure will be performed at baseline (6 weeks post-surgery) and at the end of the study (6-7 months post baseline).
16205943|NCT01347892|Other|DeNovo NT Natural Tissue Graft|DeNovo NT is a juvenile cartilagenous tissue graft, inclusive of a viable human cartilage cells. It is provided as particulated tissue pieces of approximately 1mm3 each
16205944|NCT01347879|Drug|Visonac PDT|cream application prior to illumination with red light
16205945|NCT01347879|Drug|Vehicle cream with PDT|placebo/vehicle cream application prior to illumination with red light
16205946|NCT01347866|Drug|PF-05212384|PF-05212384 intravenous infusion weekly starting at 110 mg.
16205947|NCT01347866|Drug|PD-0325901|PD-0325901 Oral twice daily (BID) dosing 2 mg BID 3 weeks on 1 week off
16205948|NCT01347866|Drug|PF-05212384|PF-05212384 intravenous infusion weekly starting at 95 mg.
16205949|NCT01347866|Drug|irinotecan|Irinotecan by intravenous infusion at 180 mg/m2 every two weeks (Q x 2 week)
16205950|NCT01347853|Drug|Ketorolac tromethamine|30 mg intranasal post-surgery for up to 5 days total
16205951|NCT01347853|Drug|Placebo|Intranasal post-surgery for up to 5 days total
16205952|NCT01347827|Device|measurements of brain tissue oxygenation|different monitors((the Hutchinson InSpectra™ StO2 Tissue Oxygenation Monitor) and in cerebral (ForeSight® Cerebral Oximeter and the Somanetics INVOS® Cerebral Oximeter ) and renal tissue (the Somanetics INVOS® Cerebral Oximeter)of brain tissue oxygenation with each other, and assess the correlation between brain tissue oxygenation and oxygenation measurements in renal and muscular tissue, as well as with conventional hemodynamic and metabolic variables, such as central venous oxygen saturation
16205953|NCT01347827|Device|measurements of brain tissue oxygenation|different monitors((the Hutchinson InSpectra™ StO2 Tissue Oxygenation Monitor) and in cerebral (ForeSight® Cerebral Oximeter and the Somanetics INVOS® Cerebral Oximeter ) and renal tissue (the Somanetics INVOS® Cerebral Oximeter) of brain tissue oxygenation with each other, and assess the correlation between brain tissue oxygenation and oxygenation measurements in renal and muscular tissue, as well as with conventional hemodynamic and metabolic variables, such as central venous oxygen saturation
16205954|NCT01347814|Drug|Domperidone 10mg|10mg domperidone tablet 30 minutes before a test-meal.
16205955|NCT01347814|Drug|Placebo|Homeopathic (Sugar) pill-Placebo
16205956|NCT01347801|Drug|GLP-1|GLP-1 1,2pmol/kg/min i.v. infusion for 4 hours
16205957|NCT01347801|Drug|Placebo (Saline)|Normal saline (NaCl 0,9%)
16205958|NCT01347801|Drug|TNF-alfa|1000ng/m2 BSA/hour i.v. infusion for 4-6 hours
16205959|NCT01347801|Other|OGTT|Oral glucose tolerance test with 75 g glucose
16205960|NCT01347801|Other|IVGTT|Intravenous glucose tolerance test with infusion of 20% glucose matching the glucose profile of the corresponding OGTT
16205961|NCT01347788|Drug|cabozantinib|Cabozantinib PO QD
16205962|NCT01347775|Device|Inspiratory muscle training (URES HS730)|It will be set at 40% of the subjects baseline maximal inspiratory pressure and increased by 10% each week by an unblinded assistant. All subjects were trained with these devices for 8-10 breaths, 3 times a day, everyday for 6 weeks
16205963|NCT01347775|Device|Sham inspiratory muscle training (URES HS730)|Subjects in the control group underwent sham training, using the same device with the diaphragm removed, thus providing no resistance. They were not given frequency or duration but told to use the device when desired.
16205964|NCT01347762|Drug|Nabilone|nabilone titrated to 1 mg by mouth twice daily
16205965|NCT01347762|Drug|Placebo|one placebo capsule by mouth twice daily
16205966|NCT01347749|Behavioral|Mindfulness & Compassion Meditation-based Exposure Therapy|A 16 week group psychotherapy intervention involving PTSD psychoeducation, breathing exercises and relaxation, and Mindfulness and Self-compassion meditation exercises in session and daily at home, and Mindfulness-based in vivo exposure exercises.
16205967|NCT01347749|Behavioral|Present Centered Therapy for PTSD|This 16 week, active group psychotherapy involves PTSD psychoeducation, supportive listening, and focusses on current stressors and PTSD symptoms.
16205968|NCT01347736|Other|scrambler therapy|Undergo scrambler therapy
16205969|NCT01347736|Other|questionnaire administration|Ancillary studies
16205970|NCT01347736|Procedure|dermatologic complications management/prevention|Undergo scrambler therapy
16205971|NCT01347723|Other|scrambler therapy|Undergo scrambler therapy
16205972|NCT01347723|Other|questionnaire administration|Ancillary studies
16205973|NCT01347723|Procedure|management of therapy complications|Undergo scrambler therapy
16205974|NCT01347710|Drug|Flurpiridaz F18|Injection of Flurpiridaz F18 for the purposes of PET myocardial profusion imaging (MPI) analysis
16205975|NCT01347710|Drug|99mTechnicium (sestamibi or tetrofosmin)|Injection of 99mTc sestamibi or tetrofosmin for the purposes of SPECT MPI analysis
16205976|NCT01347697|Procedure|Reconstruction with an acellular porcine dermal collagen implant (biological mesh)|Reconstruction of floor of lesser pelvis with an acellular porcine dermal collagen implant (biological mesh) after extended excision of rectum including levator muscles in advanced low rectal cancer.
16205977|NCT01347697|Procedure|Reconstruction with a gluteus maximus myocutaneous flap|Reconstruction of floor of lesser pelvis with an gluteus maximus myocutaneous flap after extended excision of rectum including levator muscles in advanced low rectal cancer.
16205978|NCT01347684|Behavioral|Behavioral therapy, splint therapy and physical therapy|Includes patient education, use of a mouth guard, jaw muscle exercises and brief cognitive-behavioral intervention.
16205979|NCT01347684|Drug|Standard care using current drugs|Standard Drug therapy
16205980|NCT01347671|Drug|GRT6005|25µg/day once daily
16205981|NCT01347671|Drug|GRT6005|75 µg/day once daily
16205982|NCT01347671|Drug|GRT6005|200 µg/day once daily
16205983|NCT01347671|Drug|Matching Placebo|Once daily
16205984|NCT01347658|Dietary Supplement|Echinacea purpurea|Patients will take Echinacea purpurea (500 mg every 8 hours) during 14 days.
16206371|NCT01344486|Procedure|standard pneumoperitoneum|100% carbon dioxide used for the pneumoperitoenum
16205985|NCT01347645|Drug|FOLFIRI|Comparator dose and mode of administration The FOLFIRI regimen consists of irinotecan at 180 mg/m2 (IV infusion) on Day 1 of each 14-day cycle, leucovorin at 200 mg/m2 (400 mg/m2 if using d,l-racemic mixture of leucovorin) by IV infusion on Day 1 of each cycle, and 5-FU at 400 mg/m2 as an IV bolus injection followed by a total of 2400 mg/m2 by continuous IV infusion over 46 hours over Days 1 and 2 via an ambulatory programmable pump (the use of an ambulatory pump is optional).
16205986|NCT01347645|Drug|E7820|"Test product: dose and mode of administration:
~E7820 is administered orally in tablet form once daily, every day of each 14-day treatment cycle. For the Phase Ib portion, the doses will be 40 mg/day, 70 mg/day, and 100 mg/day, and for the Pase II portion, the dose will be the MTD in combination with Irinotecan, as determined during the Phase ib portion of the study.
~The irinotecan regimen consists of an irinotecan dose of 180 mg/m2 by IV infusion once every 2 weeks (Day 1 of each 14-day cycle)."
16205987|NCT01347632|Drug|Metronidazole|All participants had BV at baseline. They all received metronidazole 500 mg po BID for 7 days
16205988|NCT01347619|Other|Toolkit only with Web Access to Online Version|NHs in this arm will receive a letter announcing the availability of an atypical antipsychotic toolkit within the facility and online at the Qualidigm website. The letter will be sent to the NH administrator, Director of Nursing, and Medical Director of each facility by Qualidigm. It will state that the toolkit is designed to provide NH staff, including prescribers, leadership, nursing staff, and patients' families with information about the use, risks and costs of atypical antipsychotics in the NH setting.
16205989|NCT01347619|Other|Toolkit, Periodic Audit/Feedback, Educational Messages|"Providing healthcare professionals with data about their performance (audit and feedback) may help improve their practice. It is more effective when clinicians previously agree to review their practice. We will use an adaptation of a Medicaid Utilization Report developed by AM Hamer. This report will show current atypical antipsychotic prescribing rates in the NH, with comparisons to state and national levels, and information regarding summary evidence for atypical antipsychotics from the AHRQ atypical antipsychotic CERSG. Reports will be sent to the NH administrator, Director of Nursing, and Medical Director of the facilities randomized to the moderate intensity arm on an every 4-month basis."
16205990|NCT01347619|Other|Items in Arm 2 plus Academic Detailing Program|This arm will receive the same information, toolkit, letters, and audit and feedback reports distributed to homes in the moderate-intensity arm. In addition, two visits to the NH will be scheduled by a pharmacist educator specially trained in the pharmacology of atypical antipsychotics, and communication techniques. Staff will be provided with up-to-date, unbiased information about antipsychotic use in NHs based on the AHRQ CER Review product adaptations. The educator will deliver targeted messages relevant to each stakeholder regarding roles in decision-making around the use atypical antipsychotic therapy in the NH setting. Each NH will receive up to two visits over the course of the 12-month intervention period.
16205991|NCT01347593|Drug|ceftizoxime|ceftizoxime (cefizox) injection either after clamping the cord
16205992|NCT01347580|Drug|Ticagrelor|Oral Ticagrelor loading dose (180 mg) followed by matching placebo
16205993|NCT01347580|Drug|Placebo|Placebo followed by oral Ticagrelor loading dose (180 mg)
16205994|NCT01347567|Other|Interventions with heart failure medications|Therapeutic interventions with heart failure medications per decision of treating physician for subjects in all study arms but using the different information available in each study arm.
16205995|NCT01347554|Device|Everolimus eluting stent|Comparison of the safety and efficacy between everolimus-eluting stent and zotarolimus-eluting stent resolute
16205996|NCT01347554|Device|Zotarolimus eluting stent|Comparison of the safety and efficacy between everolimus-eluting stent and zotarolimus-eluting stent resolute
16205997|NCT01347541|Behavioral|Cognitive Behavioral Therapy|Behavioral therapy includes standard cognitive behavioral therapy, with an emphasis on behavioral activation. Treatment is administered on the basis of the participants' individual needs and may continue for up to 12 months.
16205998|NCT01347541|Behavioral|Motivational Interviewing|Motivational interviewing is designed to address alcohol and drug use.
16205999|NCT01347541|Drug|FDA-Approved Anti-Anxiety Medications|Participants assigned to receive the combination therapy may receive one or more of the following medications based on their individual needs: fluoxetine, sertraline, paroxetine, buspirone, propranolol, trazodone, and any of the benzodiazepines. Participants may begin receiving medication immediately or anytime within the 12 months post-injury. Form, dosage, frequency, and duration depend on patient need, but all are prescribed in accordance with standards of care.
16206000|NCT01347541|Behavioral|Standard Care Control|Standard care control includes the usual treatment for injured trauma survivors
16206001|NCT01347528|Behavioral|Medication Adherence Support System (MASS)|The intervention consists of the use of an electronic Medication Adherence Monitor for a 6-month period as well as 2 visits to the heart failure outpatient clinic of the TweeSteden hospital (usual care). This monitor (a) dispenses all prescribed medication in the right dosage at the specified time, (b) reminds patients to take their medications through an alarm, sms or voicemail service and records adherence, and (c) sends critical data about non-adherence to the heart failure nurse, via a web application (CarebyWeb). The Medication Adherence Monitor is provided to the patient by the hospital pharmacy, including an instruction how to use the device. After the intervention patients return to usual care only. We expect a training effect, with continued improved adherence in the intervention group.
16206002|NCT01347515|Other|olive oil|"Each volunteer will be given, in random order, a single dose of 30 ml on a base of 80 g bread, of the following functional olive oils (FOO): FOO750 ppm, FOO500 ppm, which are enriched with two different amounts of broad-spectrum phenolic compounds from the virgin FOO250 ppm; all prepared at the Universitat de Lleida.
~Post-ingestion the volunteers will rest for 8h in a comfortable warm room. During the run-in period of 2 weeks prior the first postprandial study and 1 week between each FOO treatment period, all subjects will undergo a 2-day pre-treatment wash-out period of a phenol-free diet (saturated fatty acids in the diet will be 10-13% of energy in an isocaloric diet). Volunteers will avoid non-essential physical activity during the 3 days prior to the treatment day."
16206003|NCT01347463|Procedure|SCM triangle - ipsilateral nipple|draws the tract of the IJV using the SCM triangle head and the ipsilateral nipple
16206033|NCT01347242|Genetic|Autologous CD34 positive cells transduced with a lentiviral vector containing human WAS gene|transplantation of patient's autologous CD34+ cells transduced with lentiviral vector containing human WAS gene
16206034|NCT01347229|Device|SENSIMED Triggerfish®|Soft contact lens-based device for the continuous monitoring of IOP fluctuations
16206004|NCT01347450|Dietary Supplement|Cocoa powder berverage, dark chocolate bar|Sugar drink containing 30 g of cocoa powder and 50 g of a 65% dark chocolate, and the control group received 30 g of placebo drink containing 0 g of cocoa powder. Each drink was prepared by using 300 ml of water and 30 g of sugar, also were consumed twice each day: with breakfast and afternoon meal. during 7-d after the intervention started.
16206005|NCT01347450|Dietary Supplement|Placebo|Sugar drink containing 30 g of cocoa powder and 50 g of a 65% dark chocolate, and the control group received 30 g of placebo drink containing 0 g of cocoa powder. Each drink was prepared by using 300 ml of water and 30 g of sugar, also were consumed twice each day: with breakfast and afternoon meal. during 7-d after the intervention started.
16206006|NCT01347437|Behavioral|Positive STEPS|This intervention is given to patients in the experimental condition only. The Positive STEPS intervention-developed by our team-is based on general principles of cognitive-behavioral therapy as well as more specific principles of motivational interviewing32,33 and problem solving therapy. Informational, problem solving, and cognitive-behavioral STEPS are targeted over 5, in-person, intervention sessions with a PhD-level counselor. The intervention will also include a series of short videos related to the topics that the Positive STEPS intervention covers with participants. Participants in the experimental condition can also choose to receive text messages sent to their cell phone to remind them to take their medication.
16206007|NCT01347424|Drug|Paclitaxel , carboplatin, endostatin|PTX：175mg/m2，D1, q3w CBP：AUC5，D1, q3w endostatin：7.5 mg/m2 iv 3-4h， d1～15，q3w
16206008|NCT01347424|Drug|Paclitaxel and Carboplatin|PTX：175mg/m2，D1, q3w CBP：AUC5，D1, q3w
16206009|NCT01347411|Procedure|CPAP|Treatment with CPAP
16206010|NCT01347398|Procedure|PSG|Sleep study made by PSG (polysomnography)
16206011|NCT01347398|Procedure|MicroMESAM system|Sleep study made by MicroMESAM system
16206012|NCT01347385|Procedure|Laparoscopic myomectomy with unidirectional barbed suture|Patients will be randomized to repair of the uterine defect during laparoscopic myomectomy using unidirectional barbed suture material (V-Loc 180TM, CovidienTM). For patients randomized to the barbed suture arm of the trial, any secondary fibroid that is greater than 5cm intra-operatively (as measured by a laparoscopic measurement instrument) will also be closed with barbed suture material. The cut-off of 5cm will be used, since it is generally above this size when uterine defects need to be closed in multiple layers, making the barbed suture potentially useful. Any other secondary fibroids less than 5cm will be closed with traditional extracorporeal suturing in both arms of the trial, since these can usually be closed in one layer.
16206013|NCT01347385|Procedure|Traditional suture material|Patients will be randomized to repair of the uterine defect during laparoscopic myomectomy using traditional extracorporeal suturing using absorbable monofilament suture material.
16206014|NCT01347372|Behavioral|Peer Mentor Training|Peer mentors will complete a training program (up to 20 hours) during which they will be evaluated. This face-to-face training applies an interactive format, with a combination of lectures, question/answer sessions, and experiential learning (e.g. role-playing, simulations) and practice sessions.
16206015|NCT01347359|Behavioral|One-on-one peer support|The peer support intervention will take the form of a one-on-one peer mentoring program, using a mutually agreed upon method of communication between each pair of peer mentor and EIA participant (either by telephone or face-to-face meeting at a neutral public location). The research team will pair trained peer mentors and individuals with EIA as closely as possible based on such characteristics as sex, age, working status, and specific disease/type of IA. Peer mentors will be responsible to initiate and maintain contact with individuals with EIA. Individuals with EIA and peer mentors will be asked to have contact once a week for 30 minutes during the 12-week study period. Meetings/ interactions will not be prescribed; rather they will be defined by the individual with EIA. Peer mentors will provide support based on the needs of the individual they are mentoring. As such the nature of each interaction is likely to vary among pairs and from one interaction to the next.
16206016|NCT01347359|Behavioral|Standard of care|"Standard of care is at the discretion of the treating rheumatologist. In addition to information and patient education about the underlying disease process provided at the time of diagnosis, it may include referral to allied health professionals (e.g., physiotherapist, occupational therapist, podiatrist, social worker). This may be via referral to The Arthritis Society or directly to individual practitioners. In addition, it may include referral to voluntary support programs in the community (e.g., Arthritis Self-Management Program)."
16206017|NCT01347346|Genetic|Autologous CD34 positive cells transduced with a lentiviral vector containing human WAS gene|transplantation of patient's autologous CD34+ cells transduced with lentiviral vector containing human WAS gene
16206018|NCT01347333|Radiation|Stereotactic body radiosurgery|36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction)
16206019|NCT01347333|Radiation|Stereotactic Body Radiotherapy|26-30 Gy / 1 fraction OR 36-45 Gy / 3 fractions (12-15 Gy per fraction) OR 40-50 Gy / 5 fractions (8-10 Gy per fraction)
16206020|NCT01347320|Other|Preoperative MRI|Preoperative staging
16206021|NCT01347307|Radiation|SBRT for Benign Extradural Spine Tumors|14-25 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)
16206022|NCT01347307|Radiation|SBRT for Vertebral/Paraspinal Metastases|12-16 Gy / 1 fraction OR 21-27 Gy / 3 fractions (7-9 Gy per fraction) OR 25-30 Gy / 5 fractions (5-6 Gy per fraction)
16206023|NCT01347294|Drug|Bleomycin|Intralesional
16206024|NCT01347294|Drug|Fibrovein|Intralesional
16206025|NCT01347294|Drug|Bleomycin + Fibrovein|Intralesional
16206026|NCT01347281|Procedure|Injection of [18F]HX4|"Injection of [18F]HX4 before treatment (baseline) and after radiotherapy with 20 +/-4 Gy:
~[18F]HX4 PET scans; 444 MBq (12 mCi) [18F]HX4 administrated via a bolus IV injection. Image acquisition: static scan at 240 min p.i.
~Venous blood sampling: before injection of [18F]HX4 (blood hypoxia markers) Follow-up (3 months after treatment): [18F]FDG PET in treatment position"
16206027|NCT01347268|Procedure|GnRH antagonist|GnRH antagonist administration and continued low dose r-FSH 75 IU
16206028|NCT01347268|Procedure|withdrawing GnRH agonists|withdrawing GnRH agonists and continued low dose r-FSH 75 IU
16206029|NCT01347255|Drug|LEO90100 cutaneous spray, ointment|once daily application, 4 weeks
16206030|NCT01347255|Drug|LEO 90100 cutaneous spray, ointment, vehicle with betamethasone dipropionate|once daily application, 4 weeks
16206031|NCT01347255|Drug|LEO 90100 cutaneous spray, ointment, vehicle|once daily application, 4 weeks
16206035|NCT01347203|Drug|DPOC-4088|A single oral dose of DPOC-4088 prolonged release tablet 100 mg (Formulation A = 16 hr release formulation)
16206036|NCT01347203|Drug|DPOC-4088|A single oral dose of DPOC-4088 prolonged release tablet 200 mg (Formulation A = 16 hr release formulation)
16206037|NCT01347203|Drug|DPOC-4088|A single oral dose of DPOC-4088 prolonged release tablet 100 mg (Formulation B = 20 hr release formulation)
16206038|NCT01347203|Drug|DPOC-4088|A single oral dose of DPOC-4088 prolonged release tablet 200 mg (Formulation B = 20 hr release formulation)
16206039|NCT01347190|Biological|CR002 Liquid API|A single nominal dose of CR002 (three different dose groups) will be inhaled as an aerosol mist produced by an I-neb Adaptive Aerosol Delivery (AAD) System.
16206040|NCT01347190|Biological|Placebo|A single nominal dose of Placebo will be inhaled as an aerosol mist produced by an I-neb Adaptive Aerosol Delivery (AAD) System.
16206041|NCT01347177|Procedure|Zirconia-based adhesive bridge|Zirconia-based adhesive bridge will be used to replace the missing tooth/teeth.
16206042|NCT01347177|Procedure|Metal-based adhesive bridge|The metal-based adhesive bridge will be used to replace the missing tooth/teeth.
16206043|NCT01347164|Behavioral|RISE life coaching intervention|6 2-hour sessions
16206044|NCT01347164|Behavioral|HIV Counseling|Standard one-hour HIV counseling session
16206045|NCT01347151|Device|The glidescope video laryngoscopy|
16206046|NCT01347151|Device|The Pentax airwayscope|
16206047|NCT01347138|Other|case management|confirmation of hospital visit date, checking the adverse effect and treatment compliance
16206048|NCT01347125|Device|ImCardia Device|The device operates by harnessing energy expended by the left ventricle (LV) during Systole and returning it to the heart during Diastole thereby making it available to augment diastolic performance
16206049|NCT01347112|Drug|Varenicline|varenicline 1.0 mg dose, twice daily for 12 weeks
16206050|NCT01347112|Drug|placebo|sugar pill twice daily for 12 weeks
16206051|NCT01347099|Behavioral|Internet-based cognitive behavior therapy|Internet-delivered CBT. Contact with therapist thru an e-mail system. 10 weeks
16206052|NCT01347099|Behavioral|Support therapy on Internet|Internet-delivered support therapy. Contact with therapist thru an e-mail system. 10 weeks
16206053|NCT01347086|Drug|Matching placebo (low dose)|single dose of matching placebo
16206054|NCT01347086|Drug|BI 207127 NA (medium dose)|Single does of BI 207127 NA
16206055|NCT01347086|Drug|BI 207127 NA (low dose)|single dose of BI 207127 NA
16206056|NCT01347086|Drug|Matching placebo (medium dose)|Single dose of matching placebo
16206057|NCT01347086|Drug|BI 207127 NA (high dose)|Single dose of BI 207127 NA
16206058|NCT01347086|Drug|Matching placebo (high dose)|Single dose of matching placebo
16206059|NCT01347073|Drug|HPN-100|HPN-100 is a pro-drug of PAA that combines with glutamine to provide an alternative vehicle for waste nitrogen elimination. It is a liquid with minimal taste and odor. Approximately three teaspoons of HPN-100 (~17.4 mL) delivers an equivalent amount as PBA that 40 tablets of NaPBA.
16206060|NCT01347060|Drug|fluticasone propionate/salmeterol xinafoate combination|Fluticasone propionate/salmeterol xinafoate combination for asthma, all doses (100mcg/50mcg, 250 mcg/50mcg and 500 mcg/50mcg)
16206061|NCT01347060|Drug|inhaled corticosteroids|Inhaled corticosteroids: beclomethasone dipropionte, mometasone, fluticasone propionate, budesonide, and flunisolide
16206062|NCT01347034|Procedure|External Beam Radiation Therapy (RT)|"Day 1: Start external beam RT, 25 fractions from days 1-33 administered Monday through Friday only (no conventional external beam RT on days 6, 7, 13, 14, 20, 21, 27, or 28
~Days 57-70: Surgery will occur 3-5 weeks after the final dose of external beam RT.
~Day 78-91: First post-operative visit
~Days 91-365: Clinical follow-up
~Beyond day 365, follow-up will be conducted using the standard of care approach applicable to these patients for the determination of disease recurrence, progression and survival."
16206063|NCT01347034|Biological|Autologous Dendritic Cells|"Prior to each injection on Arm B, patients may receive prophylactic doses of a first generation cephalosporin antibiotic per physician discretion.
~Following each DC injection, Arm B patients will assess procedure-associated pain on a scale of 0-10. The next Monday following each DC injection, the patient will be called and questioned about such procedure associated toxicities."
16206064|NCT01347021|Procedure|sacrospinous colpopexy versus high uterosacral colpopexy|Women with uterine prolapse grade III or IV were randomly allocated to the sacrospinous colpopexy or high uterosacral colpopexy with vaginal hysterectomy.Before the surgery P-Qol questionnaire were completed and urogynecological examination include de POP-Q system was done. All patients underwent clinical check-ups 1, 6 and 12 months postoperatively. Each check-up included clinical examination and questionnaire.
16206065|NCT01347008|Drug|Sildenafil citrate|Oral sildenafil citratre, 50mg b.i.d., 8 weeks
16206066|NCT01347008|Drug|Placebo (Sugar pill)|Placebo pills similar to sildenafil citrate pills, b.i.d for 8 weeks
16206067|NCT01346995|Other|Experimental knee pain|Injection of 1 ml hypertonic saline (5.8%) into the infrapatellar fat pad
16206068|NCT01346995|Other|Non-painful control injections|Injection of isotonic saline into the infrapatellar fat pad
16206069|NCT01346982|Drug|Silimarine|darunavir/ritonavir 600/100 mg + silimarine (150 mg every 8 hours)
16206070|NCT01346969|Drug|EXC 001|Single-dose administered by injection four different times
16206071|NCT01346969|Drug|EXC 001|Single reduced dose compared to Group 1 administered by injection at the same four time periods as Group 1
16206072|NCT01346969|Drug|EXC 001|Single reduced dose compared to Groups 1 and 2 administered by injection at the same four time periods as Groups 1 and 2
16206073|NCT01346969|Drug|EXC 001|Same sinlge dose as Group 1 administered by injection at the same four time periods as Groups 1, 2, and 3
16206074|NCT01346943|Device|Altura Medical Abdominal Aortic Aneurysm Stent-Graft|Altura Medical AAA Stent Graft System
16206075|NCT01346930|Drug|Macitentan|10 mg, tablet, once daily
16206076|NCT01346917|Drug|Lidocaine|Lidocaine 1mg/kg(loading dose, just before skin incision) and lidocaine(in normal saline, total 240cc) 1mg/kg/hr with ketorolac 90mg for 24hrs.
16206077|NCT01346917|Drug|Normal saline|Normal saline 5cc(loading dose, just before skin incision) and normal saline 240cc with ketorolac 90mg for 24hrs.
16206078|NCT01346865|Drug|Cilostazol|Cilostazol 100mg bid
16206079|NCT01346865|Drug|Placebo|Placebo 1tablet bid
16206185|NCT01345851|Radiation|stereotactic body radiation therapy|Undergo hypofractionated RT
16206080|NCT01346852|Drug|Asthma treatment with an asthma-related medication and at least one asthma controller medication|participants with an asthma diagnosis who also had at least one dispensing event of an asthma-related medication and had at least one asthma controller medication (inhaled corticosteroids containing inhalers, methylxanthines, leukotriene receptor antagonists, cromolyn sodium) or albuterol.
16206081|NCT01346839|Behavioral|Contact Intervention|The intervention will include activities such as electronic communication and surveillance that facilitate the care of patients experiencing delays. A trained chart reviewer will conduct chart reviews on trigger-positive patients to confirm they are at risk for care delays and this will be followed by an electronic and/or verbal communication to the provider. The intervention will be compared to usual care at both sites.
16206082|NCT01346826|Drug|Standard 2 hours-infusion|"Patients without any infusion reactions during more than 4 infusions for 2 hours are randomized to one of three study groups.
~After randomization to 2 hours-infusion group, patients get 5 mg/kg infliximab infusion for 2 hours. Total infusion number after randomization is 7."
16206083|NCT01346826|Drug|Accelerated 1 hour-infusion|"Patients without any infusion reactions during more than 4 infusions for 2 hours are randomized to one of three study groups.
~After randomization to 1 hour-infusion group, patients get 5 mg/kg infliximab infusion for 1 hour. Total infusion number after randomization is 7."
16206084|NCT01346826|Drug|Accelerated 30 minutes-infusion|"Patients without any infusion reactions during more than 4 infusions for 2 hours are randomized to one of three study groups.
~After randomization to 30 minutes-infusion group, patients get 5 mg/kg infliximab infusion for 1 hour. If any infusion reactions do not develop during 2 infusions for 1 hour, patients get further 5 mg/kg infliximab infusion for 30 minutes. The total number of 30 minutes-infusion is 5."
16206085|NCT01346800|Drug|Prasugrel|Assessment of prasugrel metabolic ratio and phenotyping of CYP2B6/2C9/2C19/3A4
16206086|NCT01346800|Drug|Ritonavir|Assessment of prasugrel metabolic ratio and phenotyping of CYP2B6/2C9/2C19/3A4 in presence of ritonavir
16206087|NCT01346787|Drug|CARFILZOMIB, CYCLOPHOSPHAMIDE, DEXAMETHASONE|Patients will start induction treatment with Cyclophosphamide given orally at the dose of 300 mg/m2 on days 1, 8, 15. Low dose Dexamethasone will be given orally at the dose of 40 mg on days 1, 8, 15, 22 or 20 mg on days 1-2, 8-9,15-16, 22-23. Carfilzomib = 20 mg/m2 IV once daily on days 1, 2, of cycle 1 only followed by 36 mg/ m2 days 8, 9, 15, 16 in cycle 1, then for all subsequent doses 36 mg/ m2 IV once daily on days 1, 2, 8, 9, 15, 16, followed by 13-day rest period (day 17 through 28). Each cycle will be repeated every 28 days for a total of 9 courses. MANTEINANCE PERIOD At the end of induction phase (9 courses), maintenance phase with Carfilzomib alone IV at 36 mg/ m2 IV on days 1, 2, 15, 16 will start, until progression or intolerance. For patients who show evidence of progression during maintenance phase, the frequency of Carfilzomib can be increased to days 1, 2, 8, 9, 15, 16 at the discretion of the investigator, or the patient may be removed from the study
16206088|NCT01346774|Drug|Cranberry powder capsules|2 cranberry powder capsules twice a day
16206089|NCT01346774|Drug|Placebo powder capsules|2 placebo capsules twice a day
16206090|NCT01346761|Behavioral|Telephone Genetic Counseling|Participants will complete a pre-test session and a test results disclosure session (if tested) with a licensed, board-certified genetic counselor over the telephone. Counseling sessions will be audiotaped for quality control of intervention.
16206091|NCT01346761|Behavioral|In-Person Genetic Counseling|Participants will complete a pre-test session and a test results disclosure session (if tested) with a licensed, board-certified genetic counselor in person. Counseling sessions will be audiotaped for quality control of intervention.
16206092|NCT01346748|Drug|statin|Sinvastatin 80 mg per day - 21 days versus placebo
16206093|NCT01346735|Other|No intervention|
16206094|NCT01346722|Other|Diet-ZnBfR|zinc biofortified rice-based diet
16206095|NCT01346722|Other|Diet- CR|conventional rice-based diet
16206096|NCT01346722|Other|Diet-ZnBfR|zinc biofortified rice-based diet
16206097|NCT01346722|Other|CR + Zn|conventional rice-based diet plus zinc fortificant (Diet-CR+Z).
16206098|NCT01346696|Device|OsseoSpeed™ TX implant (Ø 4.0 mm, length 6 mm)|
16206099|NCT01346683|Device|OsseoSpeed TX|OsseoSpeed TX implants of lengths 8-17 mm
16206100|NCT01346670|Drug|LipoCol and Mevacor|To evaluate the relative bioavailability of lovastatin and its ß-hydroxy acid of 600 mg LipoCol Forte® Capsules compared to that of one 20 mg Mevacor® Tablet after single oral administration in healthy subjects using a 2x2 crossover design.
16206101|NCT01346657|Drug|Nifidipine & LipoCol|The effect of LipoCol Forte® capsules on the pharmacokinetics of nifedipine after administering single-dose combination in healthy subjects.
16206102|NCT01346644|Other|Infant formula|Powder infant formula
16206103|NCT01346644|Other|Infant formula|Powder infant formula
16206104|NCT01346631|Other|paleolithic diet|The diet consists of unlimited quantities of meat and fish, fruits and vegetables, eggs, nuts and water. Foods to be avoided include grains, wheat products, legumes, soy, potatoes and corn, rice, legumes, processed meats, soft drinks, dairy products and sugar. Allowed in moderation include coffee, alcohol,cooking oil, honey, salt, dried fruit.
16206105|NCT01346592|Biological|Trivalent split influenza vaccine (TIV)|
16206106|NCT01346592|Biological|MF59-adjuvanted trivalent influenza vaccine (aTIV)|
16206107|NCT01346592|Biological|Licensed comparator trivalent split influenza vaccine (comparator TIV)|
16206108|NCT01346579|Other|laboratory biomarker analysis|Correlative sciences
16206109|NCT01346566|Device|Cionni Modified Capsule Tension Ring|Cionni ring was used to fixate the capsular bag to the sclera and IOL was implanted in-the-bag
16206110|NCT01346553|Device|ESVV device|wearing the ESVV device for 6 hours
16206111|NCT01346540|Drug|BIBF 1120|VEGF inhibitor
16206112|NCT01346540|Drug|Placebo|BIBF 1120 placebo
16206113|NCT01346514|Behavioral|Intensive Addiction/Housing Case Management|AHCM provided: 1) support in obtaining/maintaining housing through education about resources, coordination with VA and community housing program providers, assistance in establishing housing program eligibility, and problem-solving around threats to housing stability; 2) support for SUD and related issues that affect housing status through treatment engagement/re-engagement, referrals for needed services (e.g. psychiatric, medical, vocational), and addressing substance use issues proactively; 3) promotion of residential stability through Life Skills Training, which was designed to improve key skills (room and self-care, money management, and community participation).
16206740|NCT01341873|Other|questionnaire administration|Ancillary studies
16206114|NCT01346514|Behavioral|Housing Support Group|The HSG focused on gaining support from fellow study participants and learning from those who successfully obtained housing. Group facilitators provided education about housing resources and assistance with housing-related issues.
16206115|NCT01346475|Drug|valacyclovir|1000 mg orally three times daily for 5 weeks
16206116|NCT01346475|Drug|Valacyclovir|500 mg orally once daily for 5 weeks
16206117|NCT01346462|Behavioral|Patient-Centered Transition Intervention|Community Health Workers will act as PaCT Partners for uninsured/Medicaid patients who are being discharged from the Hospital of the University of Pennsylvania and Presbyterian Hospital. PaCT Partners will help patients to overcome the challenges of transition, including arranging primary care provider (PCP) follow-up, filling medication prescriptions and obtaining referrals to community-based social services.
16206118|NCT01346449|Behavioral|Provide menu with visual cue and calorie information|Menu to be provided prior to placing the food order.
16206119|NCT01346449|Behavioral|Provide menu with visual cue but no calorie information|Menu to be provided prior to placing the food order.
16206120|NCT01346449|Behavioral|Provide menu with no visual cue but with calorie information|Menu to be provided prior to placing the food order.
16206121|NCT01346449|Behavioral|Provide menu with no visual cue and no calorie information|Menu to be provided prior to placing the food order.
16206122|NCT01346436|Procedure|Minimally invasive rectopexy|Use of a minimally invasive approach (robotic or laparoscopy) to perform a rectopexy
16206123|NCT01346423|Behavioral|Interdisciplinary intervention|Interdisciplinary collaboration deals with tasks often complex which require different skills to make a wide assessment.In this study the treatment team consists of a physician, a physiotherapist and a social service worker. The main goal for the team is to make a survey of the patient's situation, in which the biomedical tradition to make a diagnosis is replaced by a disability diagnosis, with systematically identification of barriers for return to work. The conclusion of the team will be followed by a targeted rehabilitation plan. Factors assessed to be the major cause of the reduced function at work will have priority in the following rehabilitation process. One of the team members will be responsible for the further process to follow the plan to help the patient back to work, in cooperation with the patient, the workplace, the general practitioner, and NAV.
16206124|NCT01346423|Behavioral|Control Group, Brief Intervention|The brief intervention is a standardized intervention and the essential features are interview and examination by a specialist in physical medicine and rehabilitation. Patients will be given time to express their concerns and problems in daily activities. The examination is thorough with detailed feedback on findings and normal functions, and clear and consistent explanations on pain and defense mechanisms. Somatic findings will be explained.Unless pathological findings, the patient will be encouraged to physical activity.
16206125|NCT01346410|Radiation|Stereotactic Body Radiotherapy|Suggested fractionation is 20-25 Gy / 1 fraction OR 30-36 Gy / 3 fractions (10-12 Gy per fraction) OR 40-45 Gy / 5 fractions (8-9 Gy per fraction)
16206126|NCT01346397|Drug|cyclosporine or tacrolimus|after alemtuzumab, cyclosporine or tacrolimus was administered
16206127|NCT01346384|Device|laryngeal tube (VBM Medizintechnik)|laryngeal tube number 4
16206128|NCT01346371|Drug|Refresh Tears 0.5% Lubricant Eye Drops|
16206129|NCT01346371|Drug|Bepreve 1.5% Ophthalmic Solution|
16206130|NCT01346358|Biological|IMC-CS4|
16206131|NCT01346332|Device|Iontophoresis System with Headset|Iontophoresis of an anesthesia solution to the tympanic membrane using the Acclarent Iontophoresis System with Headset
16206132|NCT01346319|Drug|ABT-SLV361|For dose groups 1, 2 and 3 medication is taken 1 time per day the first day followed by 2 times per day for 14 days. For dose groups 4 and 5, medication is taken 1 time per day for the first day followed by 2 times per day for 28 days.
16206133|NCT01346319|Drug|placebo|For dose groups 1, 2 and 3 medication is taken 1 time per day the first day followed by 2 times per day for 14 days. For dose groups 4 and 5, medication is taken 1 time per day for the first day followed by 2 times per day for 28 days.
16206134|NCT01346306|Device|Eldith Company - direct current stimulator|Direct current stimulation montage 1.
16206135|NCT01346306|Device|Eldith Company - direct current stimulator|Direct current stimulation montage 2.
16206136|NCT01346293|Biological|Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus|0.5 mL, Intramuscular (DTap-IPV); Subcutaneous (M-M-R®II and VARIVAX®)
16206137|NCT01346293|Biological|Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus|0.5 mL, Intramuscular (IM) DAPTACEL®; Subcutaneous (SC) MMR®II and VARIVAX®; IM or SC IPOL®
16206138|NCT01346293|Biological|Diphtheria and Tetanus Toxoids and Acellular Pertussis + Measles, Mumps, Rubella + Varicella Virus|0.5 mL, Intramuscular (DTap-IPV); Subcutaneous (M-M-R®II and VARIVAX®)
16206139|NCT01346293|Biological|Diphtheria and Tetanus Toxoids and Acellular Pertussis + Poliovirus + MMR + Varicella Virus|0.5 mL, Intramuscular (IM) DAPTACEL®; Subcutaneous (SC) MMR®II and VARIVAX®; IM or SC IPOL®
16206140|NCT01346267|Procedure|Real Acupressure Band|Acupressure wristband
16206141|NCT01346267|Procedure|Placebo Acupressure Band|Sham wristband
16206142|NCT01346254|Drug|Vildagliptin|50mg tablets once daily 20 min before breakfast for 3 months
16206143|NCT01346254|Drug|Pioglitazone|30mg tablets once daily 20 min before breakfast for 3 months
16206144|NCT01346254|Behavioral|Life-Style Modification|All study participants were counselled regarding life-style modification including regular exercise, weight loss and diet.
16206145|NCT01346241|Behavioral|Intensive Panic Control Treatment (IPCT)|A manualized treatment that consists of psychoeducation about panic disorder
16206146|NCT01346228|Behavioral|Panic Control Treatment (PCT)|2 Day treatment for Panic Disorder
16206147|NCT01346215|Biological|heparin sodium|5000 UI/mL
16206148|NCT01346215|Biological|heparin sodium|5000 UI/mL
16206149|NCT01346189|Behavioral|Behavioral Economic Intervention|Various combinations of financial incentives to patients and providers.
16206186|NCT01345838|Procedure|labrum|Two years follow-up after PAO, to find any differences among patients with and without known acetabular labral tears
16206187|NCT01345825|Other|Resistance training|Week 1: 2 sets x 12 repetitions at 12 RM Week 2: 3 sets of 12 repetitions with 12 RM Week 3: 3 sets of 10 repetitions with 10 RM Week 4-5: 3 sets of 10 repetitions with 10 RM Week 6: 3 sets of 8 repetitions with 8 RM Week 7: 4 sets of 8 repetitions with 8 RM Week 8: 4 sets of 8 repetitions with 8 RM
16206150|NCT01346176|Other|Advance Directive Forms|Consenting subjects will be randomly assigned to one of 3 study arms. Subjects will receive a different AD form based on which arm they have been randomly assigned. Once a completed AD form is received, a debriefing session will be held to alert patients to exactly how the 3 ADs used in the study differ. Once patients are fully informed about the variations in the ADs, they will have an opportunity to change their AD selections prior to finalizing them as a part of their medical record. A final satisfaction interview will take place with a research associate who will contact patients via telephone to administer a satisfaction questionnaire.
16206151|NCT01346163|Drug|PF 03654746|All participants will receive 3 weeks of PF-03654746 and 3 weeks of placebo. PF-03654746 and placebo will be administered in a flexible titration regimen, beginning with 0.5 mg/d. If 0.5 mg/d is well tolerated, the dose will be increased to 1.0 mg/d after 5 days. If 1.0 mg/d is not well tolerated, the dose will be decreased to 0.5 mg/d, with the goal of achieving a stable dose of PF-03654746 within the first two weeks of dosing and avoiding further dose changes during the final week of dosing.
16206152|NCT01346163|Other|Placebo|Placebo will be used as a comparator to the active arm.
16206153|NCT01346137|Drug|Meloxicam|15 mg versus 30 mg per day P.O. for 15 days during 3 menstrual cycles
16206154|NCT01346124|Radiation|High Dose Intensity Modulated Proton Radiation|Radiation given once a day Monday-Friday
16206155|NCT01346098|Procedure|Pancreaticoduodenectomy with pancreatic anastomosis|Standard lymphadenectomy, end-to-side two-layer pancreaticojejunostomy and duodenojejunostomy will be performed. If the pylorus is preserved, so will be the right gastric artery, unless the artery is damaged or hindering adequate gastric mobilization. No prokinetic agent will be administered routinely, but IV metoclopramide will given on demand (10 mg , three times daily). Prophylaxis will consist of octreotide (0,1 mg three times daily from day 0 to 7), low molecular weight heparin and a single dose of antibiotic (cefazolin 2 g). Early postoperative analgesia will be achieved by epidural or, when contraindicated, patient-controlled analgesia
16206156|NCT01346098|Procedure|Total pancreatectomy with islet autotransplantation|If the patient will be assigned to this group, the surgeon will complete the pancreatectomy preserving the spleen. The body and tail of the pancreas will be sent to the islet isolation facility. Islets will be isolated and purified according to the automated method described by Ricordi. The resulting islet tissue will be suspended in a cold isotonic saline solution and infused into the portal vein during the next 24h.
16206157|NCT01346085|Drug|CNI free immunosuppression|Immunosuppression consisted of: (i) pre-Tx rapamycin treatment (0.1 mg/kg/day) for at least 30 days; (ii) induction therapy with ATG (1.5 mg/kg/day for 4 days starting at day -1) and a steroid bolus (methyl-prednisolone 500 mg, day -1) plus low dose steroids (prednisone, 10 mg/day) and interleukin-1 (IL-1) receptor antagonist (100 mg/day) for 2 weeks (with ATG and steroid bolus administered only prior to the 1st islet infusion; (iii) maintenance with rapamycin (0.1 mg/kg/day) plus mycophenolate mofetil (2 g/day).
16206158|NCT01346072|Drug|tolvaptan|oral, 30 mg, single dose, one time administration
16206159|NCT01346059|Drug|Vancomycin|Vancomycin solution will be instilled through the colonic catheter every 6 hours. 250cc of solution will be used each time. The solution is 2 grams vancomycin mixed in 1 liter normal saline.
16206160|NCT01346059|Drug|Saline|Saline, used as a placebo, will be instilled through the colonic catheter. Every 6 hours, 250cc of saline will be used.
16206161|NCT01346007|Biological|7-valent pneumococcal conjugate vaccine|A 0,5 ml dose of 7-valent pneumococcal conjugate vaccine in both arms A 0,5 ml anamnestic dose of 7-valent pneumococcal conjugate vaccine in subjects with idiopathic nephrotic syndrome 12 months after priming
16206162|NCT01345994|Procedure|electro-acupuncture|acupuncture stimulation with electricity
16206163|NCT01345981|Drug|Lidocaine|dosage 20 mg and 40 mg
16206164|NCT01345968|Drug|Ferinject 50 mg/ml|iv administration of max. 50 ml (Dilution: 20 ml in 30 ml NaCl 0.9%) in 30 minutes
16206165|NCT01345968|Drug|NaCl 0.9%|iv administration of max. 50 ml in 30 minutes
16206166|NCT01345942|Drug|RO5428029|Single oral dose
16206167|NCT01345929|Drug|CXA-201|CXA-201 IV infusion (1500mg q8) for 7 days
16206168|NCT01345929|Drug|Levofloxacin|Levofloxacin IV infusion (750mg qd) for 7 days
16206169|NCT01345916|Drug|CHF 1535 100/6 NEXT DPI® 2 months|CHF 1535 100/6 NEXT DPI® 2 months
16206170|NCT01345916|Drug|CHF 1535 100/6 pMDI 2 months|CHF 1535 100/6 pMDI 2 months
16206171|NCT01345916|Drug|BDP DPI 2 months|BDP DPI 2 months
16206172|NCT01345903|Procedure|therapeutic conventional surgery|Undergo robotic-assisted surgery
16206173|NCT01345890|Procedure|electrical stimulation|sub motor threshold stimulation of mylohyoid muscles
16206174|NCT01345877|Procedure|first degree cutaneous burn injury|application of thermode (5 x 2.5 cm) to lower leg temperature 47.0 C, 420 s
16206175|NCT01345864|Drug|Scopolamine + Donepezil Placebo + PF-04995274 Placebo|Scopolamine 0.5 mg subcutaneously x 1 dose on Day 1 Donepezil-matching placebo tablet x 1 dose on Day 1 PF-04995274 matching placebo oral liquid x 1 dose on Day 1
16206176|NCT01345864|Drug|Scopolamine + Donepezil 5 mg + PF-04995274 Placebo|Scopolamine 0.5 mg subcutaneously x 1 dose on Day 1 Donepezil 5 mg tablet orally x 1 dose on Day 1 PF-04995274 matching placebo oral liquid x 1 dose on Day 1
16206177|NCT01345864|Drug|Scopolamine + Donepezil 10mg + PF-04995274 Placebo|Scopolamine 0.5 mg subcutaneously x 1 dose on Day 1 Donepezil 10 mg (2 x 5 mg tablets) orally x 1 dose on Day 1 PF-04995274 matching placebo oral liquid x 1 dose on Day 1
16206178|NCT01345864|Drug|Scopolamine + Donepezil Placebo + PF-04995274 0.25 mg|Scopolamine 0.5 mg subcutaneously x 1 dose on Day 1 Donepezil-matching placebo tablet x 1 dose on Day 1 PF-04995274 0.25 mg oral liquid x 1 dose on Day 1
16206179|NCT01345864|Drug|Scopolamine + Donepezil Placebo + PF-04995274 15 mg|Scopolamine 0.5 mg subcutaneously x 1 dose on Day 1 Donepezil-matching placebo tablet x 1 dose on Day 1 PF-04995274 15 mg oral liquid x 1 dose on day 1
16206180|NCT01345851|Radiation|hypofractionated radiation therapy|Undergo image-guided hypofractionated Radiation Therapy over 35 minutes 5 days a week for 2 weeks
16206181|NCT01345851|Other|laboratory biomarker analysis|Correlative studies
16206182|NCT01345851|Radiation|image-guided radiation therapy|Undergo 5 fractions of image-guided hypofractionated Radiation Therapy boost.
16206183|NCT01345851|Drug|carboplatin|The maximal chemotherapy treatment dose for carboplatin during the 3 week radiation therapy is AUC 2.
16206184|NCT01345851|Drug|paclitaxel|The maximal chemotherapy treatment dose for paclitaxel during the 3 week radiation therapy is 45mg/m2.
16206192|NCT01345786|Drug|Commercial NOMAC-E2|1 x 2.5 mg NOMAC/1.5 mg E2 fixed dose combination commercial tablet orally in the morning on Day 1 for all periods
16206193|NCT01345786|Drug|"Phase 3 NOMAC-E2 Batch A"|"1 x 2.5 mg NOMAC/1.5 mg E2 fixed dose combination tablet from the Phase 3 clinical trial program (Batch A) orally in the morning on Day 1 for all periods"
16206194|NCT01345786|Drug|"Phase 3 NOMAC-E2 Batch B"|"1 x 2.5 mg NOMAC/1.5 mg E2 fixed dose combination tablet from the Phase 3 clinical trial program (Batch B) orally in the morning on Day 1 for all periods"
16206195|NCT01345773|Procedure|Gastric surgery|Patients receiving gastric cancer surgery will be prospectively observed for the development of venous thromboembolism
16206196|NCT01345747|Device|laryngeal tube (VBM Medizintechnik, Sulz, Germany)|laryngeal tube suction number 3 and 4
16206197|NCT01345734|Drug|liraglutide|Liraglutide will be prescribed and titrated by the treating physician and will be self-administered by the subject s.c. (under the skin) once daily. Study participants being treated with GLP-1 (Glucagon-Like Peptide 1)agonists or DDP-4-inhibitors (Dipeptidyl-peptidase 4 ) should stop treatment when initiating liraglutide treatment.
16206198|NCT01345721|Biological|MenACWY-CRM|
16206199|NCT01345708|Drug|prednisone, low dose rituximab|"Patients with warm AIHA will receive:
~Rituximab 100 mg i.v.weekly (fixed dose irrespective of body surface area) for 4 consecutive weeks (days +7, +14, +21, +28), and prednisone 1 mg/kg/die p.o. days from day +1 to day +30, followed by tapering (10 mg/week until 0.5/mg/kg/die, then 5 mg/week until stop)
~Patients with CHD will receive:
~Rituximab 100 mg i.v.weekly (fixed dose irrespective of body surface area) for 4 consecutive weeks (days +7, +14, +21, +28)"
16206200|NCT01345682|Drug|Afatinib|Once daily
16206201|NCT01345682|Drug|Methotrexate|Weekly
16206202|NCT01345669|Drug|Placebo|Once daily
16206203|NCT01345669|Drug|Afatinib|Once daily
16206204|NCT01345656|Drug|BAY94-8862|Two 1.25 mg BAY94-8862 and 2 placebo tablets for duration of 4 weeks
16206205|NCT01345656|Drug|BAY94-8862|Four 1.25 mg BAY94-8862 tablets for duration of 4 weeks
16206206|NCT01345656|Drug|BAY94-8862|One 10 mg BAY94-8862 tablet for duration of 4 weeks
16206207|NCT01345656|Drug|BAY94-8862|Part B only: Four 1.25 mg BAY94-8862 tablets in the morning and four tablets in the evening for duration of 4 weeks
16206208|NCT01345656|Drug|Placebo|Placebo tablets for duration of 4 weeks
16206209|NCT01345656|Drug|Spironolactone|Part B only: 25 mg spironolactone once daily with up-titration to 50 mg once daily starting at day 15, if serum potassium is less or equal to 4.8 mmol/L, for duration of 4 weeks
16206210|NCT01345643|Other|Maintenance of hemoglobin level not less than 10g/dL|The patient's hemoglobin level is maintained not less than 10g/dL perioperatively.
16206211|NCT01345643|Other|Transfusion trigger based on WCPTS|Determination of whether a patient needs red blood cell transfusion or which hemoglobin level should be maintained is based on WCPTS
16206212|NCT01345630|Drug|Maraviroc|Maraviroc tablet 150 mg once daily for 96 weeks.
16206213|NCT01345630|Drug|Emtricitabine/tenofovir|Emtricitabine/tenofovir tablet 200/300 mg once daily for 96 weeks.
16206214|NCT01345630|Drug|darunavir/ritonavir 800/100 mg|darunavir/ritonavir 800/100 mg
16206215|NCT01345630|Drug|placebo for emtricitabine/tenofovir|placebo for emtricitabine/tenofovir
16206216|NCT01345630|Drug|placebo for maraviroc|placebo for maraviroc
16206217|NCT01345604|Procedure|transcruciate injection of 20cc of normal saline|Group 2 (control group) will receive a transcruciate injection of 20cc of normal saline through the posterior cruciate ligament during the procedure (in addition to a subarachnoid block and femoral nerve block pre-operatively).
16206218|NCT01345604|Procedure|transcruciate injection of 20 cc of 0.5% Ropivacaine|Group 1 (study group) will receive a transcruciate injection of 20 cc of 0.5% Ropivacaine through the posterior cruciate ligament during the procedure (in addition to a subarachnoid block and femoral nerve block pre-operatively).
16206219|NCT01345591|Procedure|Fat Grafting|
16206220|NCT01345578|Drug|human hepatocyte transplantation|"Transplantation of hepatocytes into the liver will be through the portal vein. The portal vein will be accessed transhepatically, by umbilical vein, or surgically by a peripheral mesenteric vein.
~The subject will be evaluated de novo and if they are a candidate for orthotopic liver transplantation they will receive the transplant. Even if the subject receives the hepatocyte transplant and it does not work, they will be evaluated for orthotopic liver transplantation as if they never received the hepatocyte transplant.
~If at 6 months we see an improvement in disease, we will recommend a re-transplantation with a goal of complete correction of disease and until the subject is no longer required to be a candidate for organ transplantation. Subjects will be re-evaluated every 6 months for re-transplantation. Subjects will remain on the waiting list for organ transplantation. Further radiation therapy will not be needed prior to re-transplantation."
16206221|NCT01345578|Radiation|Preparative Radiation Therapy|Just prior to the hepatocyte transplant, a portion of the right hepatic lobe comprising between 35-50% of the entire liver volume will be irradiated to a dose of 7.5-10 Gy in a single fraction using a linear accelerator-based stereotactic radiosurgery system with intensity-modulated radiation therapy planning (IMRT).
16206222|NCT01345565|Drug|human hepatocytes|"The intrahepatic site for liver cell transplantation has been associated with the best engraftment and function based on animal experiments. Several approaches for access to the portal vein will be considered. The technique used will be determined based on what is considered best for the child based on risk/benefit at the time.
~We propose to attempt to infuse approximately 5-10% of the hepatic mass in order to provide improved hepatic function. Since we do not yet know from our experience so far the correct number of cells to transplant in order to improve function, we will continue to infuse hepatocytes as donors become available until the patient improves to the point where they are no longer meet the criteria for organ transplantation. The subject will be evaluated de novo and if they are a candidate for orthotopic liver transplantation they will receive the transplant."
16206223|NCT01345552|Radiation|Stereotactic Radiosurgery (SRS)|Dose and fractionation will be dependent on the lesion location and lesion size and is up to the exact fractionation and dose is at the discretion of the treating physician. A minimum of 48 hours must be used in between SRS treatments at each site. Note that patients can have SRS everyday or multiple SRS sessions in one day as long as the minimum time for each treatment site is met. For example, if two lung lesions, brain, adrenal, and liver sites were being treated both lung sites could be treated Monday, Wednesday, and Friday and the adrenal, liver and brain lesions treated Tuesday, Thursday
16206224|NCT01345539|Radiation|Stereotactic Radiosurgery (SRS)|Dose and fractionation will be dependent on the lesion location and lesion size, the exact fractionation and dose is at the discretion of the treating physician. A minimum of 48 hours must be used in between SRS treatments at each site. Note that patients can have SRS everyday or multiple SRS sessions in one day as long as the minimum time for each treatment site is met. For example, if two lung lesions, adrenal, and liver sites were being treated, both lung sites could be treated Monday, Wednesday, and Friday, the liver on Tuesday, Thursday and the following Tuesday, and the adrenal on Monday, Wednesday, Friday of the second week.
16206225|NCT01345526|Device|Reconval K1 Cream|
16206226|NCT01345526|Device|Reconval Cream|
16206227|NCT01345513|Other|Sample Collection for Genome-Wide Sequencing|Collection of archival tumor tissue, fresh tumor biopsy, blood sample, and pleural effusion (if available)or ascites (if available)
16206228|NCT01345500|Other|Higher Carbohydrate, Lower Fat Diet|Study participants will receive prepackaged prepared foods as needed to achieve a meal plan, free-of-charge for a 12-month period. The lower fat, higher carbohydrate diet provides 60% energy from carbohydrate, 20% energy from fat, and 20% energy from protein. The diet falls within the range of current dietary recommendations.
16206229|NCT01345500|Other|Lower carbohydrate, Higher fat diet|Study participants will receive prepackaged prepared foods as needed to achieve a meal plan, free-of-charge for a 12-month period. The lower carbohydrate, higher fat diet provides 45% energy from carbohydrate, 35% energy from fat, and 20% energy from protein. The diet falls within the range of current dietary recommendations.
16206230|NCT01345500|Other|Individualized Counseling|Participants assigned to the usual care group will be provided consultation with a research staff dietetics professional, who will provide publicly available print material that describes dietary and physical activity guidelines to promote weight loss and maintenance, at baseline (after randomization) and again at 6 months.
16206231|NCT01345487|Other|Vegetable Protein|Vegetable protein in the form of fava beans/split peas
16206232|NCT01345487|Other|Animal protein|Protein in the form of minced pork/beef
16206233|NCT01345461|Device|transcutaneous electrical muscle stimulation, (model DS7A, Digitimer, Welwyn, Garden City, Hertfordshire, UK)|two constant current high voltage stimulators delivered ten single stimuli twitches with biphasic square pulses at widths of 300 μs. A train generator was then switched on, triggering the delivery a 35 Hz current in bouts of 3 seconds periods separated by 1-second pause for a total of 40 tetanic contractions. In immediate succession to the tetanic contractions a second series of ten single twitch stimuli ended the protocol.
16206234|NCT01345448|Drug|Brimonidine|0.1% Brimonidine Lotion, dosed once.
16206235|NCT01345448|Drug|Placebo Lotion|Placebo Lotion dosed once.
16206236|NCT01345435|Procedure|Telemonitoring group|The Telemonitoring group will be provided blood glucose meter, body composition analyzer, and remote monitoring PC. They should visit the site once per every 2 months (8 weeks), and measure their blood glucose using a provided blood glucose monitor twice a day during study period (once after first morning urination and once before going to bed). After measurement of blood glucose and body composition, the subjects should make transmit measured information through Smart Care PC into a centralized server of Smart Care Center. At Smart care Center, care manager will provide remote blood glucose monitoring and individual diabetes case management
16206237|NCT01345435|Procedure|Telemonitoring & Telemedicine|The Telemonitoring & Telemedicine group will be provided blood glucose meter, body composition analyzer, and remote monitoring PC. They should measure their blood glucose using a provided blood glucose monitor twice a day during the study period. After measurement of blood glucose and body composition, the subjects should make transmit measured information through Smart Care PC into a centralized server of Smart Care Center. At Smart care Center, care manager will provide remote blood glucose monitoring and individual diabetes case management. A remote medical doctor should provide medical consultation to the subjects through videotelephony using the remote monitoring PC and then issue electronic prescriptions.
16206238|NCT01345435|Other|SMBG|The subjects who are assigned in the control group will be provided blood glucose Monitor. The subjects who are assigned in the control group should perform the same blood glucose measurement same as the test group during the study, and measured results should be recorded in a diary of self blood glucose measurement. In addition, the subjects should visit the site once per every two months (8 weeks).
16206239|NCT01345422|Other|Wii Balance Board|Participant will undergo Nintendo Wii Balance Board training for two months , five days a week for 30 minutes
16206240|NCT01345396|Behavioral|Health education about asthma|Three face-to-face appointments (<20, 36 weeks of gestation and 12 weeks after the baby birth). Topics: What is asthma? What influence the course of asthma? How to monitor it? How to manage it?
16206241|NCT01345383|Procedure|bronchoscopy|Routine bronchoscopy under local anesthesia (lidocain). Duration: +/- 10 min
16206242|NCT01345370|Drug|Temozolomide|According to sites procedures
16206243|NCT01345370|Radiation|Radiation Therapy|According to sites procedures
16206244|NCT01345357|Drug|CEP-9722|CEP-9722 will be administered orally from day 2 through day 7 of each cycle beginning with cycle 2. The starting dose will be 150 mg twice daily. Following cycle 2, the dose will either be decreased to 150 mg daily or increased to 200 mg twice daily in a cohort of 3 to 4 new patients. Subsequent cycles will increase the dose by 100 mg twice daily in cohorts of 3 to 4 patients (with criteria to expand to 6 patients) to a maximum of 400 mg twice daily. Patients must receive CEP-9722 to remain in the study. Once treatment with CEP-9722 is discontinued, patients will withdraw from the study.
16206245|NCT01345357|Drug|Gemcitabine|Gemcitabine will be administered at 1250 mg/m^2 intravenously on day 1 and day 8 of each 21-day cycle. Dosage reduction may be applied on day 8 (within a cycle) or on day 1 of the next cycle based upon the grade of toxicity experienced by the patient.
16206246|NCT01345357|Drug|Cisplatin|Cisplatin will be administered at 75 mg/m^2 intravenously on day 1 of each cycle, after the infusion of gemcitabine. Dosage reduction may be applied on day 1 of the next cycle based upon the grade of toxicity experienced by the patient.
16206247|NCT01345344|Behavioral|Cognitive Behavioral Therapy|Practicing certain cognitive and behavioral pain self-management strategies such as relaxation and changing negative thoughts about pain.
16206248|NCT01345344|Behavioral|Disease Education|Providing information about fibromyalgia, including its potential causes and management approaches.
16206372|NCT01344473|Device|Tooth Mousse creme (Casein Phosphopeptide)(RECALDENT)|TM is a water based creme containing RECALDENT. RECALDENT consists of CPP-AP: Casein Phosphopeptide - Amorphous Calcium Phosphate.
16206249|NCT01345331|Behavioral|Real stimulation VS Sham|Ear stimulation at specific points should work by stimulating a nerve called the vagus nerve. Previous research has shown that stimulating this nerve can help patients feel less pain. During any testing session, participants may receive either the real ear stimulation or a sham (placebo) treatment. The sham treatment will use the same equipment as the real treatment, but will not deliver any real stimulation to the ear. We use placebo/sham procedures in research to make sure that the study results are related to the study procedure, and not to other reasons.
16206250|NCT01345318|Biological|PF-04236921|Subjects entering this study will be given a 50 mg SC dose at baseline and then every 8 weeks through Week 40.
16206251|NCT01345318|Biological|PF-04236921|Dose escalation to 100 mg SC every 8 weeks will be allowed for subjects who have either not responded at Week 8 or have relapsed during the study.
16206252|NCT01345292|Device|Mouthwash|Rinse with 10 ml of the assigned mouthwash for 60 seconds after you brush in your usual manner twice daily for one minute using at least a one-inch strip of the assigned toothpaste
16206253|NCT01345292|Drug|Potassium nitrate toothpaste|Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste
16206254|NCT01345292|Drug|Sodium fluoride toothpaste|Brush in your usual manner twice daily for at least one minute using at least a one-inch strip of the assigned toothpaste
16206255|NCT01345279|Drug|cisplatin|50 mg/m2 IV cisplatin on day 1 and then every 3 weeks for 6 courses
16206256|NCT01345279|Drug|topotecan|topotecan 0.75 mg/m2 on days 1, 2, and 3. The regimen was repeated every 3 weeks for 6 courses
16206257|NCT01345279|Drug|paclitaxel|135 mg/m2 paclitaxel on day 1 and then every 3 weeks for 6 courses
16206258|NCT01345266|Procedure|Inhalation Profiling|All subects recieve Inhaltion Profiling there are no interventions.
16206259|NCT01345253|Drug|Belimumab|10mg/kg administered intravenously. Dosing at Weeks 0, 2, and 4, then every 4 weeks through Week 48, with a final evaluation at Week 52. All study subjects will receive standard SLE therapies during the study.
16206260|NCT01345253|Drug|Placebo|Administered intravenously. Dosing at Weeks 0, 2, and 4, and then every 4 weeks through Week 48, with a final evaluation at Week 52. All study subjects will receive standard SLE therapies during the study.
16206261|NCT01345240|Biological|GlaxoSmithKline (GSK) Biologicals' candidate Plasmodium falciparum malaria vaccine 257049|Children enrolled in 9 groups will receive 3 doses of the candidate malaria vaccine (Lot 1, 2 and 3) by intramuscular injection.
16206262|NCT01345240|Biological|Engerix-B™ vaccine|Children enrolled in 2 groups will receive 4 doses of Engerix-B™ vaccine by intramuscular injection. Children enrolled in all other groups will receive one dose of Engerix-B vaccine by intramuscular injection.
16206263|NCT01345240|Biological|Infanrix/Hib™ vaccine|Children enrolled in all 11 groups will receive 4 doses of Infanrix/Hib™ vaccine by intramuscular injection
16206264|NCT01345240|Biological|Polio Sabin™ vaccine|Children enrolled in all 11 groups will receive 3 doses of Polio Sabin™ by intramuscular injection.
16206265|NCT01345240|Biological|Rotarix™ vaccine|Children enrolled in all 11 groups will receive 2 doses of oral Rotarix™ vaccine.
16206266|NCT01345240|Biological|Synflorix™ vaccine|Children enrolled in all 11 groups will receive 4 doses of Synflorix™ vaccine by intramuscular injection.
16206267|NCT01345240|Biological|Measles vaccine|Children enrolled in all 11 groups will receive 1 dose of measles vaccine by intramuscular injection.
16206268|NCT01345240|Biological|Yellow fever vaccine|Children enrolled in all 11 groups will receive 1 dose of yellow fever vaccine by intramuscular injection.
16206269|NCT01345227|Procedure|Intra bone marrow islet infusion|A needle for bone marrow aspiration (14 G) will be inserted into the superior-posterior iliac crest and islet suspension (1:2.5; tissue:Ringer's Lactate solution) will be infused. The entire intraBM-injection procedure last 8-15 min from the beginning of anaesthesia (short propofol sedation).
16206270|NCT01345214|Drug|ONO-7746|10mg, 20mg, 50mg, 100mg, 200mg and 300mg once-daily for 14 days
16206271|NCT01345201|Biological|OMP-18R5|IV infusion. Subjects with stable disease or a response at Day 56 will be allowed to continue until disease progression.
16206272|NCT01345188|Drug|Ranexa|1000 mg Ranexa orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.
16206273|NCT01345188|Drug|Placebo|1000 mg placebo orally once daily titrated as tolerated after 1 week up to taking 1000 mg twice daily.
16206274|NCT01345175|Drug|Rifaximin|Pt will receive rifaximin 400mg bid for 4 weeks. Patients will at this stage on a volunteer basis be asked to submit stool samples and undertake a breath test. Patients will receive the respective treatment for four weeks. Following cessation of treatment all patients will be assessed using the BFI and respective patients will have repeat stool sampling and breath testing. Patients will then have these tests repeated 4 weeks later. This corresponds to 8 weeks after the start of the trial. For those patients not undertaking stool and breath testing, they will be reminded by phone, mail or email to fill out the BFI. Before and during the trial patients will be asked to fill out a weekly stool diary to evaluate trends on bowel function.
16206275|NCT01345175|Drug|Placebo|Pt will receive placebo bid for 4 weeks. Patients will at this stage on a volunteer basis be asked to submit stool samples and undertake a breath test. Patients will receive the respective treatment for four weeks. Following cessation of treatment all patients will be assessed using the BFI and respective patients will have repeat stool sampling and breath testing. Patients will then have these tests repeated 4 weeks later. This corresponds to 8 weeks after the start of the trial. For those patients not undertaking stool and breath testing, they will be reminded by phone, mail or email to fill out the BFI. Before and during the trial patients will be asked to fill out a weekly stool diary to evaluate trends on bowel function.
16206276|NCT01345162|Drug|Ketorolac postoperative|Ketorolac 10mg 1cp x 3/die
16206277|NCT01345162|Drug|postoperative Patrol|acetaminophene 325mg+tramadol 37.5mg, 1cp x 3/die
16206278|NCT01345162|Drug|intraoperative analgesia|ketorolac 30 mg iv
16206279|NCT01345162|Drug|intraoperative analgesia|Tramadol 100 mg if Weight over 50 kg, 50 mg if weight below 50 kg
16206280|NCT01345149|Behavioral|Diet + Exercise|"Diet: Intensive counselling about calorie restriction to reduce weight gain by dietician.
~Exercise: Individual counselling"
16206281|NCT01345136|Drug|RAD001, everolimus|Adults: 10 mg p.o. daily dose, age 16 - 17: 3.0 mg/m2 p.o. daily
16206373|NCT01344460|Drug|Gadobutrol (Gadovist, BAY86-4875)|a single bolus injection of approx. 0.1mmol/kg
16206282|NCT01345123|Behavioral|Provision of condition specific shared decision making (SDM) aids only|Subjects are mailed decision aid digital video discs (DVDs) and pamphlets regarding lumbar back, hip osteoarthritis or knee osteoarthritis.
16206283|NCT01345123|Behavioral|Telephonic outreach and support by Health Coach|Subjects are direct dial attempted by Health Coaches up to three attempts. If contacted, Health Coaches tailor support around health matters of importance to the subjects and to help individuals become active participants in their treatment plans, and make more informed decisions in consort with their health care providers. The number of total contacts is determined by mutual agreement between the subject and the Health Coach. Health Coaches may provide additional educational materials and resources.
16206284|NCT01345097|Device|Total Hip Arthroplasty|Total Hip Arthroplasty
16206285|NCT01345084|Radiation|Radiation Therapy|66- 70 Gy External, Fractions of 2.0 Gy per day, 5 days a week
16206286|NCT01345084|Drug|Nimotuzumab|200 mg, IV, weekly doses during the radiation therapy until completing 6 months (Diluted into 250 mL of sodium chloride sterile solution 0.9% in intravenous infusion for 30 minutes).
16206287|NCT01345084|Drug|Cisplatin|75 mg/m2, IV, doses every 3 weeks (a total of three doses)
16206288|NCT01345058|Drug|lacosamide|"Lacosamide maximum of 200 mg/day, to be titrated as follows:
~Week 1: 50 mg twice a day
~Beginning Week 2: 100 mg twice a day."
16206289|NCT01345058|Drug|levetiracetam|Low dose ≤1500 mg/day, High dose >1500 mg/day
16206290|NCT01345045|Drug|ABT-639|ABT-639 Twice Daily for six weeks.
16206291|NCT01345045|Drug|pregabalin|pregabalin starting dose twice daily for 1 week then titrated to maintenance dose twice daily for the remainder of the study.
16206292|NCT01345045|Drug|Placebo|Placebo twice daily for 6 weeks.
16206293|NCT01345032|Other|Home visit|Patients and their homecare helper will receive visits from a clinical dietician 1 week, 2 weeks and 4 weeks after discharge. The purpose of the visits is follow up on the individual diet plan distributed at discharge and supply dietary advice.
16206294|NCT01345032|Other|Telephone consultation|Patients and their homecare helper will be contacted on telephone from a clinical dietician 1 week, 2 weeks and 4 weeks after discharge. The purpose of the telephone contact is follow up on the individual diet plan distributed at discharge and supply dietary advice.
16206295|NCT01345019|Drug|Denosumab|Administered by subcutaneous injection once every 4 weeks.
16206296|NCT01345019|Drug|Zoledronic acid|Administered by intravenous infusion over 15 minutes once every 4 weeks
16206297|NCT01345019|Drug|Placebo to Denosumab|Administered by subcutaneous injection once every 4 weeks.
16206298|NCT01345019|Drug|Placebo to zoledronic acid|Administered by intravenous infusion over 15 minutes once every 4 weeks
16206299|NCT01345019|Drug|Denosumab (for the open-label treatment phase)|Administered by subcutaneous injection once every 4 weeks.
16206300|NCT01345006|Biological|MA09-hRPE|"Cohort 1 50,000 cells
~Cohort 2 100,000 cells
~Cohort 2a Better Vision 100,000 cells
~Cohort 3 150,000 cells
~Cohort 4 200,000 cells"
16206301|NCT01344993|Biological|MA09-hRPE|Cohort 1 50,000 cells Cohort 2 100,000 cells Cohort 2a Better Vision 100,000 cells Cohort 3 150,000 cells Cohort 4 200,000 cells
16206302|NCT01344980|Procedure|Stainless steel suture|Stainless steel suture material will be used (size 3-0) in an MGH repair technique
16206303|NCT01344980|Procedure|Polypropylene suture|Polypropylene suture (size 3-0) will be used in a double-locking loop repair technique
16206304|NCT01344980|Behavioral|Aggressive early active range of motion rehabilitation|Patients undergoing this form of rehabilitation will have their splints discontinued at 4 weeks and ideally will be back at work at normal duties by 6 weeks. This rehabilitation uses more movement at a faster progression than other early active range of motion protocols.
16206305|NCT01344980|Behavioral|Early active range of motion rehabilitation|Patients undergoing this form of rehabilitation will have their splints discontinued at 6 weeks and ideally will be back at work at normal duties by 10-12 weeks. This rehabilitation uses less movement at a slower progression than the early AROM rehabilitation protocol specified in the experimental group
16206306|NCT01344967|Drug|Zoledronic acid|Zoledronic Acid at a dose of 4mg will be administered by intravenous infusion over 15 minutes in at least 100mls of saline
16206307|NCT01344954|Drug|TB-402|Administered intravenously over 10 minutes
16206308|NCT01344954|Drug|Rivaroxaban|Administered orally as a capsule once a day for 35 days
16206309|NCT01344954|Drug|TB-402|Administered intravenously over 10 minutes
16206310|NCT01344928|Behavioral|HIT exercise intervention|
16206311|NCT01344928|Behavioral|Aerobic exercise intervention|
16206312|NCT01344915|Procedure|Locked knee brace|
16206313|NCT01344915|Procedure|Locked knee brace|
16206314|NCT01344902|Drug|hexaminolevulinate HCl|200mg hexaminolevulinate HCl capsule 6 hours before colonoscopy
16206315|NCT01344876|Drug|OPB-51602|once daily during the treatment period
16206316|NCT01344863|Drug|trastuzumab [Herceptin]|600 mg subcutaneously using a single-use injection device on Day 1
16206317|NCT01344863|Drug|trastuzumab [Herceptin]|600 mg subcutaneously using a handheld syringe on Day 1
16206318|NCT01344837|Other|Diagnostic Laboratory Biomarker Analysis|Correlative studies
16206319|NCT01344837|Other|Immunohistochemistry Staining Method|Correlative studies
16206320|NCT01344837|Other|Medical Chart Review|Correlative studies
16206321|NCT01344837|Genetic|Microarray Analysis|Correlative studies
16206322|NCT01344837|Other|Study of Socioeconomic and Demographic Variables|Correlative studies
16206323|NCT01344837|Genetic|Western Blotting|Correlative studies
16206324|NCT01344824|Biological|bevacizumab|15 mg/kg once per 21 day cycle (up to 4 cycles).
16206325|NCT01344824|Drug|carboplatin|Area Under the Curve (AUC)=6, once every 21 day cycle (up to 4 cycles)
16206326|NCT01344824|Drug|erlotinib hydrochloride|150mg, daily for 21 day cycle (up to 4 cycles)
16206327|NCT01344824|Drug|pemetrexed disodium|500 mg/m2 on day 1 of a 21 day cycle (up to 4 cycles)
16206328|NCT01344811|Procedure|Telemonitoring|The Telemonitoring group will be provided the Smartphone, body composition analyzer and pedometer. They should visit the site once per every 3 months (12 weeks), and measure their body composition during study period. After measurement of body composition, the subjects should make transmit measured information through Smartphone into a centralized server of Smart Care Center. At Smart care Center, care manager will provide remote body composition and activity monitoring and individual obesity case management
16206329|NCT01344811|Other|control group|The control group will receive a weighting scale and pedometer. They should perform the same weight measurement (minimum three times a week) like the intervention group during the study, and measured results should be recorded in a diary of self body weight and the number of steps. In addition, the subjects should visit the site once per every three months (12 weeks).
16206330|NCT01344798|Biological|AAV1-gamma-sarcoglycan vector injection|single intramuscular injection into carpi radialis muscle under open procedure
16206331|NCT01344785|Procedure|Intramedullary nailing|All patients will be treated with Intramedullary nailing
16206332|NCT01344772|Procedure|Internal fixation|Two cannulated screws are placed under x-ray guidance
16206333|NCT01344772|Procedure|Total hip arthroplasty|A total hip arthroplasty is performed through a standard posterior approach
16206334|NCT01344759|Drug|Dexmedetomidine|Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump.
16206335|NCT01344759|Drug|Propofol|Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.
16206336|NCT01344720|Drug|etoricoxib|"At visit 2 eligible patients will then receive Etoricoxib 30mg for 2 weeks. Patients who achieve a clinically meaningful improvement in pain at the end of this period (defined as a ≥30% improvement in BPI avg daily pain intensity), will continue therapy up to week 5 (visit 4), if they become non-responders between week 4-5, they can be tapered off meds and then discontinued from the study. Patients who do not achieve a clinically meaningful improvement will be considered non-responders and will be randomized to receive either titration of their monotherapy or combination treatment.
~Group 1 non-responders will receive an increase in monotherapy from etoricoxib 30mg to eterocoxib 60mg/die."
16206337|NCT01344720|Drug|oxycodone|"At visit 2 eligible patients will then receive Etoricoxib 30mg for 2 weeks. Patients who achieve a clinically meaningful improvement in pain at the end of this period (defined as a ≥30% improvement in BPI avg daily pain intensity), will continue therapy up to week 5 (visit 4), if they become non-responders between week 4-5, they can be tapered off meds and then discontinued from the study. Patients who do not achieve a clinically meaningful improvement will be considered non-responders and will be randomized to receive either titration of their monotherapy or combination treatment.
~Group 2 non-responders will receive in addition to etoricoxib 30mg/day a dose of oxycodone CR 5mg q12hr (dose of 5mg tablet is available in Italy)."
16206338|NCT01344707|Drug|4SC-202|oral administration dose escalation twice daily (bid)or three times a day (tid) continuous dosing for 21 days per cycle
16206339|NCT01344694|Other|patient with liver fat|30 patient with liver fat
16206340|NCT01344694|Other|pts. with excess of visceral fat|pts. with excess of visceral fat
16206341|NCT01344694|Other|control|30 control subjects
16206342|NCT01344681|Drug|Micafungin sodium|"Treatment period (active treatment): an average 14 days
~Dosage:
~- Study Drug: Micafungin sodium (mycamine ® injections 50mg/vial) 2 vials (100mg / day)
~Administration Method:
~Study Drug: 3-5 days after fever begins. Infusion one time a day (one hour). Termination of treatment after maintaining fever for three days or the recovery of neutrophils with no fever."
16206343|NCT01344681|Drug|Itraconazole|"Treatment period (active treatment): an average 14 days
~Dosage:
~- Active Comparator: Itraconazole (Sporanox ® injection) 200 mg 2 times(400mg / day)
~Administration Method:
~Active Comparator: 200 mg two times(400 mg) a day, total of 4 times for 2 days and then one times (200 mg) a day for 12 days. Termination of treatment after keeping fever for three days or the recovery of neutrophils with no fever."
16206344|NCT01344668|Other|Enhanced Diabetes Education|Provide enhanced diabetes education
16206345|NCT01344668|Other|Standard Diabetes Education|Provide Standard Diabetes Education
16206346|NCT01344655|Drug|Atimos®|Formoterol 12 μg pMDI
16206347|NCT01344655|Drug|Serevent™|Salmeterol 25 µg pMDI
16206348|NCT01344655|Drug|Placebo|placebo
16206349|NCT01344629|Drug|Telmisartan/Amlodipin FDC|Telmisartan80mg/Amlodipin5mg FDC
16206350|NCT01344629|Drug|Telmisartan|Telmisartan 80 mg tablet
16206351|NCT01344629|Drug|Amlodipin|Amlodipin 5mg tablet
16206352|NCT01344616|Behavioral|lifestyle support|computer-based lifestyle improvement support and clinician support
16206353|NCT01344590|Other|Normal Saline|Standard saline procedure will be utilized.
16206354|NCT01344590|Other|Ethanol 70% pharmaceutical grade|70% pharmaceutical grade ethanol will be instilled in the line in a volume calculated to fill the lumen and the hub.
16206355|NCT01344564|Drug|Degarelix acetate, Leuprolide acetate|Degarelix acetate, 1 mo depot for 3 months Leuprolide acetate, 3 mo depot once
16206356|NCT01344551|Dietary Supplement|Cocoa Drink|High Flavanol (495mg) Low Flavanol (23mg) Matched for macro and micro nutrients
16206357|NCT01344538|Drug|Ginger Root Extract (Pure Encapsulations)|2.0 g per day (10:1 extract)
16206358|NCT01344538|Dietary Supplement|Placebo Capsule|2.0 g per day
16206359|NCT01344525|Procedure|Laparoscopic gastric sleeve|Laparoscopic gastric sleeve
16206360|NCT01344525|Procedure|Gastric Banding|Gastric Banding
16206361|NCT01344525|Procedure|Multidisciplinary lifstyle intervention|Multidisciplinary lifstyle intervention (OPTIFAST®52-program)
16206362|NCT01344525|Procedure|Roux-en-Y Bypass|Roux-en-Y Bypass
16206363|NCT01344512|Drug|Ceftazidime|Bloods sampling on patient treated with Ceftazidime between 48 hours and 4 days after beginning of treatment.
16206364|NCT01344512|Drug|Ciprofloxacin|Bloods sampling on patient treated with Ciprofloxacin between 48 hours and 4 days after beginning of treatment.
16206365|NCT01344512|Drug|Voriconazole|Bloods sampling on patient treated with Voriconazole between 48 hours and 4 days after beginning of treatment.
16206366|NCT01344499|Procedure|Carbon dioxide|standard pneumoperitoneum with 100% CO2
16206367|NCT01344499|Procedure|full conditioning|Pneumoperitoneum with CO2 + 4% of oxygen + 10% nitrous oxide + 100% RH + T° 32°C
16206368|NCT01344499|Drug|Adept|instillation of 1 liter of fluid at the end of laparoscopy
16206369|NCT01344499|Drug|Ringer Lactate|instillation of 1 liter of fluid at the end of laparoscopy
16206370|NCT01344486|Procedure|full conditioning|addition of 4% oxygen + 10% nitrous oxide to the pneumoperitoneum + humidification + temperature regulation at 32°C
16206374|NCT01344447|Drug|Gadobutrol (Gadovist, BAY86-4875)|A single bolus injection of approx. 0.1mmol/kg
16206375|NCT01344421|Procedure|Minimally invasive approach for Periacetabular osteotomy|A peri-acetabular osteotomy is a surgery performed to correct the dysplastic acetabulum and reduce joint contact pressures and early osteoarthritis.
16206376|NCT01344408|Procedure|Computer-training|"The computer-training program Move IT To Improve IT is a exercise program which is installed and used on a Apple Imac in the patients home to support vestibular rehabilitation"
16206377|NCT01344395|Drug|ropivacaine and ketorolac|The RK-group receives four intra-articular injections via catheter with a total volume of 40 ml (380 mg ropivacaine and 60 mg ketorolac) combined with 4 intravenous injections of saline during 24 hours postoperatively
16206378|NCT01344395|Drug|Ketorolac|The K-group receives four intra-articular injections via catheter with a total volume of 40 ml saline combined with 4 intravenous injections of ketorolac (total 60 mg) during 24 hours postoperatively
16206379|NCT01344382|Behavioral|Community Reinforcement and Family Training|The philosophy of Community Reinforcement and Family Training (CRAFT) is that drug abuse is caused by multiple biological and environmental factors, many of which are beyond the parents' control. However, because parents have an important relationship with their child, they may able to influence his or her behavior. CRAFT for parents (CRAFT-P) will teach the parent new ways to interact with their child. Sessions will be designed to build the parents' motivation to comply with the training, conduct a functional analysis of their child's drug use pattern, train methods of behavior management and communication skills, enrich the parent's life and to suggest and motivate treatment entry.
16206380|NCT01344382|Behavioral|Al-Anon Facilitation|Al-Anon Facilitation (ANF) parallels the Twelve Step Facilitation intervention developed by Nowinski et al. (1992) for Project MATCH. The content focuses on introducing parents to Alanon or Naranon's purpose and philosophy, educating about 12-step concepts, the fellowship community, denial and enabling, acceptance, caring detachment, and surrendering to a higher power. The trainer's role is to help the parent to gain insight into the ways they interact with their child and to educate and encourage the parent to become actively involved in a 12-step community and to take advantage of its many offerings.
16206381|NCT01344369|Drug|Norethindrone/Ethinyl Estradiol|0.4 mg/0.035 mg Chewable Tablets
16206382|NCT01344369|Drug|FEMCON® Fe|0.4 mg/0.035 mg Chewable Tablets
16206383|NCT01344356|Radiation|stereotactic body radiotherapy|14-16 Gy / 1 fraction OR 18-21 Gy / 3 fractions (6-7 Gy per fraction)OR 25-45 Gy / 5 fractions (5-9 Gy per fraction)
16206384|NCT01344356|Radiation|Stereotactic body radiotherapy|8-12 Gy / 1 fraction OR 12-18 Gy / 3 fractions (4-6 Gy per fraction) OR 35-45 Gy / 5 fractions (7-9 Gy per fraction)
16206385|NCT01344343|Other|Accelerated surgical hip fracture repair|Accelerated hip fracture surgery defined as arrival in the operation room within 6 hours of diagnosis of a hip fracture requiring surgery
16206386|NCT01344304|Drug|Aprepitant / Fosaprepitant|"Aprepitant:
~125 mg PO on day 1 80 mg PO on days 2 to 3
~Fosaprepitant:
~150 mg IV on day 1"
16206387|NCT01344291|Drug|Curcumin|Curcumin is prescribed to new cases of hyperprolactinoma
16206388|NCT01344278|Behavioral|Lifestyle Counseling|A lifestyle curriculum of individualized telephone counseling calls, augmented with e-mails and an interactive study Web site.
16206389|NCT01344252|Drug|Lidocaine|We will made anesthesia with topical lidocaine and compared with subtenon anesthesia
16206390|NCT01344239|Procedure|Limb remote ischemic preconditioning(LRIP)|LRIP consisted of three cycles of left upper limb ischemia induced by inflating a blood pressure cuff on the left upper arm to 200mmHg, with an intervening 5 minutes of reperfusion, during which time the cuff was deflated.
16206391|NCT01344226|Drug|loteprednol 0.5% ophthalmic solution|Lotemax to be used QID starting day of cataract surgery and 21 days after for total of 22 days.
16206392|NCT01344213|Drug|Pregabalin|Oral single-dose of pregabalin (150 mg) and placebo (P) 1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg.
16206393|NCT01344213|Drug|Celecoxib|Oral single-dose of celecoxib (400 mg) and placebo(C)1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg.
16206394|NCT01344213|Drug|Pregabalin with celecoxib|Oral single-dose of pregabalin (150 mg) and celecoxib (400 mg) (PC) 1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg.
16206395|NCT01344213|Drug|Placebo|Oral single dose of placebo 2 capsules 1-2 hours before starting spinal anesthesia with intrathecal morphine 0.2 mg
16206396|NCT01344200|Drug|Celecoxib|In Phase I twenty (20) children will receive either celecoxib 14 or 7 mg/kg 120-180 minutes prior to lumbar puncture (LP). In Phase II forty-five (45) children will receive celecoxib 14 mg/kg, 7 mg/kg or placebo in one of 5 time intervals, 1-24 hours prior to LP.
16206397|NCT01344200|Drug|Placebo|In Phase II forty-five (45) children will receive celecoxib 14 mg/kg, 7 mg/kg or placebo in one of 5 time intervals, 1-24 hours prior to LP.
16206398|NCT01344187|Drug|riboflavin solution|0.12% riboflavin ophthalmic solution
16206399|NCT01344187|Drug|placebo solution|0.0% riboflavin ophthalmic solution
16206400|NCT01344187|Device|KXL System|30 mW/cm2
16206401|NCT01344174|Drug|5 days dexamethasone therapy|dexamethasone 10mg, intravenously, po daily for the first 5 days
16206402|NCT01344161|Dietary Supplement|Placebo|dosage form:lactose dosage: 25 micrograms frequency: every day duration: 12weeks
16206403|NCT01344161|Dietary Supplement|vitamin D|dosage form:cholecalciferol dosage: 25 micrograms (1000 International Unit) frequency: every day duration: 12weeks
16206404|NCT01344148|Drug|INH RIF Rifb PZA EMB AZT 3TC D4T EFV|The first cohort study is the patients begin HAART after anti-TB therapy 2 weeks,and the second cohort is after 8 weeks begin HAART. Anti-TB therapy program is 2HREZ-4HRifb. And the first line of HAART plan is AZT+3TC+EFV and the second line plan is D4T+3TC+EFV.If begin with HAART and the RIF will change to Rifb.
16206405|NCT01344135|Dietary Supplement|Dietary supplementation|"Phase A, Rehabilitation (4 months): 3 nutritional supplements daily
~Phase B, Maintenance (8 months): nutritional supplementation on advice (1 supplement daily)
~Phase C, Follow-up (3 months): no supplementation"
16206406|NCT01344135|Dietary Supplement|Placebo supplement|"Phase A, Rehabilitation (4 months): 3 placebo nutritional supplements daily
~Phase B, Maintenance (8 months): No supplementation
~Phase C, Follow-up (3 months): No supplementation"
16206452|NCT01343823|Drug|ecallantide 30 mg|Administered as one 3 mL SC injection containing 30 mg ecallantide
16206453|NCT01343823|Drug|ecallantide 10 mg|Administered as one 3 mL SC injection containing 10 mg ecallantide.
16206407|NCT01344135|Behavioral|Nutritional counselling|"Phase A, Rehabilitation (4 months): No counselling
~Phase B, Maintenance (8 months): Nutritional counselling (4x)
~Phase C, Follow-up (3 months): No counselling
~Aim:
~Optimising dietary intake to physical activity pattern and energy expenditure.
~Minimize deterioration of dietary intake during acute exacerbations.
~Optimize dietary lipid profile with respect to total fat intake; trans fatty acids and proportion of poly-unsaturated fatty acids to modulate cardiovascular risk and muscle fatty acid metabolism.
~Increasing adherence/compliance by addressing issues like taste fatigue, gastro-intestinal symptoms, individual preferences and lifestyle."
16206408|NCT01344135|Behavioral|Feedback on physical activity level|"Phase A, Rehabilitation (4 months): No exercise counselling
~Phase B, Maintenance (8 months): Exercise counselling (2x)
~Phase C, Follow-up (3 months): No exercise counselling
~Aim:
~Integration of exercise behaviour into daily routine
~Improvement of self-regulation skills (e.g. self-monitoring, goal setting, action planning)
~Increasing adherence/compliance by addressing issues like coping with difficult situation, individual preferences and lifestyle"
16206409|NCT01344122|Other|KPI training only|See comparison arm description.
16206410|NCT01344122|Other|KPI plus OLI|See experimental arm description.
16206411|NCT01344083|Drug|T1210|2 drops T1210 once a day
16206412|NCT01344083|Drug|Olopatadine hydrochloride|2 drops once a day Olopatadine
16206413|NCT01344070|Drug|one of the 15 drugs listed below|single, oral, immediate-release, non-combinational innovator formulation
16206414|NCT01344070|Drug|one of the 15 drugs listed below|single, oral, immediate-release, non-combinational generic formulation a
16206415|NCT01344070|Drug|one of the 15 drugs listed below|single, oral, immediate-release, non-combinational generic formulation b
16206416|NCT01344070|Drug|one of the 15 drugs listed below|single, oral, immediate-release, non-combinational generic formulation c
16206417|NCT01344057|Biological|Seasonal Influenza Vaccine|This phase II is performed as a multicenter study in elderly subjects. Enrolled subjects received one single IM dose of trivalent subunit inactivated adjuvanted flu vaccine during the vaccination visit, according to the study protocol (follow-up period: until day 22) .
16206418|NCT01344044|Device|BCI|24 half-hour sessions over 8 weeks, i.e. 3 sessions per week, followed by 3 once-monthly boosters.
16206419|NCT01344031|Drug|Akt Inhibitor MK2206|Given PO
16206420|NCT01344031|Drug|Anastrozole|Given PO
16206421|NCT01344031|Drug|Fulvestrant|Given IM
16206422|NCT01344031|Other|Laboratory Biomarker Analysis|Correlative studies
16206423|NCT01344018|Procedure|therapeutic conventional surgery|
16206424|NCT01344018|Radiation|3-dimensional conformal radiation therapy|
16206425|NCT01344005|Other|caregiver-related intervention or procedure|
16206426|NCT01344005|Other|questionnaire administration|
16206427|NCT01344005|Procedure|quality-of-life assessment|
16206428|NCT01344005|Procedure|radiography|
16206429|NCT01343992|Behavioral|Bed rest|Patients will rest in bed ten minutes after the embryo transfer.
16206430|NCT01343992|Behavioral|No bedrest|Patients will not rest in bed after the embryo transfer.
16206431|NCT01343966|Drug|MABT5102A|Repeating subcutaneous injection
16206432|NCT01343966|Drug|MABT5102A|Repeating intravenous infusion
16206433|NCT01343966|Drug|placebo|Repeating subcutaneous injection
16206434|NCT01343966|Drug|placebo|Repeating intravenous infusion
16206435|NCT01343953|Procedure|Cord Blood Transplantation|One or 2 cord blood units containing alone or both together more than 4x107 frozen nucleated cells/Kg with no more than 2 out of 6 HLA mismatches between them and with the patients for acquired Severe Aplastic Anemia
16206436|NCT01343940|Behavioral|Project dulce|"Participating families are assigned to a legal/developmental specialist who joins health care team during well-child visits and home visits. The specialist (a Dulce family partner) supports parent around child development issues, addresses unmet basic needs (e.g., housing, utilities, food, etc.), and makes referral to existing agencies and services. Specialist meets with family during all routine well-child visits scheduled in primary care between birth and 6 months (1-mo, 2-mo, 4-mo, 6-mo). Parent may meet with specialist before or after scheduled appointment, and may request a home visit. Specialist will be available by phone for consultation."
16206437|NCT01343940|Behavioral|Safety intervention|Participating family is assigned a safety specialist. Meeting with the safety specialist will occur before or after a routine well-child visit or at a separately agreed upon time. The specialist will discuss infant injury risks associated with transportation and sleep. The specialist will provide safety equipment (car seat and pack-and-play) and instruct the parent in their proper use.
16206438|NCT01343927|Behavioral|Weekly yoga classes|Manualized 12-week Hatha yoga intervention developed specifically for chronic low back pain in adult populations; classes meet once each week at community-based locations.
16206439|NCT01343927|Behavioral|Individual physical therapy treatment|12 weeks of fifteen individual physical therapy sessions divided as follows: Week 1 intake appointment; weeks 2-4 two appointments per week; weeks 5-12 one appointment per week.
16206440|NCT01343927|Behavioral|Education|"Participants given The Back Pain Helpbook and periodic newsletters addressing back pain and self care."
16206441|NCT01343901|Drug|Bevacizumab|Participants with mCRC and having exclusively liver or liver and lung metastases who were receiving bevacizumab as part of first line treatment for potentially resectable liver metastases as per treating physician's discretion will be observed. All concomitant medications as used in routine clinical practice are allowed.
16206442|NCT01343888|Drug|PegIFN/RBV|PegIFN/RBV for 48 weeks
16206443|NCT01343888|Drug|BI 201335|BI 201335 once daily high dose
16206444|NCT01343888|Drug|BI 201335|BI 201335 once daily low dose
16206445|NCT01343888|Drug|Placebo|
16206446|NCT01343875|Procedure|tear of the distal tendon in the biceps muscle|
16206447|NCT01343862|Drug|D-cycloserine|single dose of D-cycloserine given 48-72 hours after moderate traumatic brain injury
16206448|NCT01343862|Drug|placebo|A sugar pill will be given to those patients randomized to the control group at 48-72 hours after moderate brain injury
16206449|NCT01343836|Other|Autologous Tenocyte Implantation|Intratendinous ATI (autologous tenocyte injection) with eccentric exercises
16206450|NCT01343836|Other|Saline|Intratendinous saline injection with eccentric exercises
16206451|NCT01343823|Drug|ecallantide 60 mg|Administered as two 3 mL SC injections, each containing 30 mg ecallantide
16206455|NCT01343823|Drug|placebo match for 30 mg ecallantide arm|One 3 mL SC injection of matching placebo given to subjects randomized to the 30 mg ecallantide arm.
16206456|NCT01343823|Drug|placebo match for 10 mg ecallantide arm|One 3 mL SC injection of matching placebo given to subjects randomized to the 10 mg ecallantide arm.
16206457|NCT01343810|Behavioral|Mindfulness Based Stress Reduction (MBSR)|The MBSR program consists of 8 weekly classes that last for 2.5 hours each and a commitment to daily meditation practice for the duration of the course. Classes include didactic instruction on mindfulness and its relationship to stress and health, guided meditation practices, and group discussion. Mindfulness meditation practices include awareness of breathing, awareness of emotions, body scan, mindful hatha yoga, mindful walking, mindful eating, mindful listening, and lovingkindness (metta). Participants are expected to practice formal meditation outside of class for 20-45 min per day, 6 days per week. In addition, participants are encouraged apply mindfulness to everyday activities like eating, communicating with others, and hobbies. Written materials and audio CDs with guided meditations and yoga are provided. The course also includes one full day (7-hours) of meditation on a Saturday following the 6th week of class.
16206458|NCT01343810|Behavioral|Mindfulness-Based Stress Reduction (MBSR)|The MBSR program consists of 8 weekly classes that last for 2.5 hours each and a commitment to daily meditation practice for the duration of the course. Classes include didactic instruction on mindfulness and its relationship to stress and health, guided meditation practices, and group discussion. Mindfulness meditation practices include awareness of breathing, awareness of emotions, body scan, mindful hatha yoga, mindful walking, mindful eating, mindful listening, and lovingkindness (metta). Participants are expected to practice formal meditation outside of class for 20-45 min per day, 6 days per week. In addition, participants are encouraged apply mindfulness to everyday activities like eating, communicating with others, and hobbies. Written materials and audio CDs with guided meditations and yoga are provided. The course also includes one full day (7-hours) of meditation on a Saturday following the 6th week of class.
16206459|NCT01343797|Other|Glycemic and insulinemic index tests of a fruit fructose syrup and a fruit fructo-oligosaccharid syrup|One test with 65,5g of fruit (apple) extract sugar syrup with high fructose content in 250mL of water One test with 108,2g of peach purified sugar syrup with high fructo-oligosaccharid content in 250mL of water Three tests with the reference : 50g of anhydrous glucose in 250mL of water
16206460|NCT01343784|Other|Urinary voiding assessment after midurethral sling|Both groups will undergo voiding trial in the similar manner. The decision to discharge based on an objective measure (voided amount) versus based on the subjective measure (force of stream self assessment).
16206461|NCT01343758|Other|5% dextrose in normal saline|Subjects will be randomized to receive a intravenous fluid bolus of 5% dextrose in normal saline or normal saline
16206465|NCT01343732|Device|Deep TMS|deep transcranial magnetic stimulation
16206466|NCT01343719|Drug|BI 661051|medium dose solution for oral administration
16206467|NCT01343719|Drug|BI 661051|medium dose solution for oral administration
16206468|NCT01343719|Drug|BI 661051|medium dose solution for oral administration
16206469|NCT01343719|Drug|BI 661051|low dose solution for oral administration
16206470|NCT01343719|Drug|BI 661051|low dose solution for oral administration
16206471|NCT01343719|Drug|BI 661051|low dose solution for oral administration
16206472|NCT01343719|Drug|BI 661051|high dose solution for oral administration
16206473|NCT01343719|Drug|BI 661051|high dose solution for oral administration
16206474|NCT01343719|Drug|BI 661051|low dose tablet
16206475|NCT01343719|Drug|Placebo|solution for administration
16206476|NCT01343719|Drug|BI 661051|medium dose tablet
16206477|NCT01343706|Drug|Placebo|Solution for oral administration
16206478|NCT01343706|Drug|Placebo .|Immediate release solid oral dosage
16206479|NCT01343706|Drug|BI 409306|Immediate release solid oral dosage medium
16206480|NCT01343680|Drug|Heparin|5ml 10 units/ml IV heparin 3 times per week
16206481|NCT01343680|Drug|Normal saline|10ml normal saline IV weekly
16206482|NCT01343667|Device|Gore Flow Reversal System|Embolic protection by the GORE Flow Reversal System during carotid artery angioplasty and stenting
16206483|NCT01343667|Device|Gore Embolic Filter|Embolic protection by the GORE Embolic Filter during carotid artery angioplasty and stenting
16206484|NCT01343654|Behavioral|Text messaging plus EMA|Personalized, tailored text messaging to prompt medication adherence, with EMA random queries about nonadherence and drug use, and two-way messaging for participants to report critical events
16206485|NCT01343654|Behavioral|Treatment as usual|usual care in one of the three participating ID clinics, along with usual care (if any) in the community for problematic drug and alcohol use
16206486|NCT01343641|Drug|MK-0677|The oral agent MK-677 is spiropiperidine, Merck L-163 191, GH secretagogue ghrelin mimetic which increases GH and IGF-I secretion, fat free mass and energy expenditure76-79. It is produced by Merck & Co, Inc.
16206487|NCT01343641|Drug|Placebo|Inactive Pill used as a comparator
16206488|NCT01343628|Drug|Placebo Comparator|16 NET SNP rs 11648486 CC and CT individuals will receive placebo and then after one week washout period, receive atomoxetine. Medications will be given as 2 capsules 1x day for 5 days; active atomoxetine groups will receive 40 mg for 3 days, followed by 80 or 120mg (.91-1.4 mg/kg) on days 4 and 5
16206489|NCT01343628|Drug|Active Comparator: Atomoxetine, Placebo|16 NET SNP rs 11648486 CC and CT individuals will receive atomoxetine and then after one week washout period, receive placebo.Medications will be given as 2 capsules 1x day for 5 days; active atomoxetine groups will receive 40 mg for 3 days, followed by 80 or 120mg (.91-1.4 mg/kg) on days 4 and 5.
16206490|NCT01343615|Procedure|carotid stenting|A group of patients will be operated by endovascular technique. Then will be analyzed and compared with the other group in relation to clinical and radiological criteria, emphasizing the cognitive aspects.
16206522|NCT01343303|Drug|Placebo|Placebo tablet/capsule every 12 hours for 21 days
16206523|NCT01343303|Drug|JNJ-39439335|2 x 25 mg tablets once daily for 21 days
16206491|NCT01343615|Procedure|carotid endarterectomy|A group of patients will be operated by open technique. Then will be analyzed and compared with the other group in relation to clinical and radiological criteria, emphasizing the cognitive aspects
16206492|NCT01343602|Behavioral|mod. Constraint-Induced Movement Therapy|"Therapists of the intervention group are trained in CIMT at home. During an initial home visit the therapist determines together with the patient an individually tailored home training program focussing on everyday practice and instructs the non-professional coach. For four weeks the patients will perform 2 hours of daily training at home together with an instructed non-professional coach (e.g. family member) applying shaping techniques (i.e. 20 consecutive days). Patients are supposed to wear a resting hand splint for the entire treatment period for 4 to 6 hours daily. During the four weeks the therapist will provide 5 weekly visits at the patients' home to instruct and supervise the training."
16206493|NCT01343602|Other|Therapy as usual|Therapy as usual consists of the therapy, which is usually provided by the occupational or physical therapist. Therapy will be applied at the patients home or at the therapists' practice.
16206494|NCT01343589|Dietary Supplement|milk fat|39 g milk fat per day in 12 weeks
16206495|NCT01343576|Dietary Supplement|milk fat|45 g milk fat per day in 4 weeks
16206496|NCT01343563|Procedure|Trigeminal Nerve Stimulation|External trigeminal nerve stimulation (TNS) as an adjunctive treatment added onto antidepressant medications.
16206498|NCT01343537|Other|Neuro Monitoring|Neuro monitoring from day 4 to day 14 post subarachnoid hemorrhage for cerebral vasospasm
16206499|NCT01343511|Biological|human cord blood mononuclear cells|Participants will be given rehabilitation therapy plus hCB-MNCs transplantation.
16206500|NCT01343511|Biological|human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells|Participants will be given rehabilitation therapy plus and hCB-MNCs and hUC-MSCs transplantation.
16206501|NCT01343498|Drug|BEZ235|BEZ235 will be given on a dose-escalation design, beginning at 200 mg BID (SDS sachet) in 3 patients and progressing to 400 mg, 600 mg, and 800 mg respectively based on tolerability.
16206502|NCT01343485|Behavioral|Computer reminder system|Intervention sites will receive computer kiosk with study specific software to assist in reminding study participants to return for HPV vaccine series
16206503|NCT01343472|Behavioral|WISP supervision|WISP entails a warning session (Orientation Hearing) where the rules of parole are laid out and parolees are told that any violation of stated parole conditions will be sanctioned with a brief jail term (typically a few days in jail). WISP includes regular random drug testing.
16206504|NCT01343472|Behavioral|Parole-as-usual|Parolees are supervised under standard parole supervision practice in Washington State.
16206505|NCT01343459|Radiation|HIOB|"IOERT single shot as a boost followed by hypofractionated WBRT (HIOB)
~IOERT is performed on mobile or fixed linacs
~Reference dose: 11 Gy specified as maximum dose, with a minimum target volume dose of 90% encompassing the PTV (i.e. 10 Gy).
~WBRT
~must start within day 36- 56 postoperatively (week 6 - 8 p.o.) in case of adjuvant hormonal treatment (or no further tumor specific medication)
~In case of adjuvant chemotherapy, a time - gap between IOERT and WBRT up to 9 months is allowed.
~Single reference dose per fraction: 2,7 Gy (ICRU)
~Number of fractions: 15, Number of fractions per week: 5
~Total WBRT dose: 40,5 Gy"
16206506|NCT01343420|Biological|Dog Hair Extract, ALK-Abelló, Inc.|ALK-Abelló dog epithelial 1:10w/v glycerin
16206507|NCT01343407|Drug|MK-1029 10 mg|Six capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design
16206508|NCT01343407|Drug|MK-1029 100 mg|Five capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design
16206509|NCT01343407|Drug|Placebo for MK-1029 10 mg|"Six capsules once daily for 5 days in Period 1, and the same in Period 2, 3, or 4 in a crossover design."
16206510|NCT01343407|Drug|Placebo for MK-1029 100 mg|Five capsules once daily for 5 days in Period 2, 3, or 4 in a crossover design
16206511|NCT01343394|Biological|Autologous Human Umbilical Cord Blood|6 million cells/kg will be administered intravenously at one treatment time point.
16206512|NCT01343381|Drug|Hepalean Heparin|400 units per kilogram bolus prior to initiation of CPB
16206513|NCT01343381|Drug|PPC Heparin|400 unit per kilogram bolus prior to initiation of CPB
16206514|NCT01343368|Drug|Leuprolide|Long-acting leuprolide 11.25 mg intramuscularly (IM) pre-transplant (HCT) and 3 months post-HCT PLUS Short-acting leuprolide 0.2 mg subcutaneously (SQ) daily for 14 days
16206515|NCT01343368|Biological|hematopoietic cell transplant|Conventional bone marrow transplant regimen.
16206516|NCT01343368|Biological|reduced intensity allogeneic HCT|A reduced-intensity conditioning transplant is a bone marrow or cord blood transplant (also called a BMT) that uses less intense treatment to prepare for transplant than a standard transplant does. While a standard transplant uses the pre-transplant treatment to destroy most of the disease cells, a reduced-intensity transplant relies on the donor's immune cells to fight disease.
16206517|NCT01343355|Drug|Tamibarotene|Oral administration of tamibarotene 2 mg daily over a period of 12 weeks, then 4mg daily for another 12 weeks.
16206518|NCT01343342|Dietary Supplement|n-3 PUFA supplementation|3g per day of n-3 PUFA supplementation (1.9g EPA, 1.1g DHA). 5 capsules per day (1g fish oil each, 5g of fish oil/day)
16206519|NCT01343329|Drug|Esmolol|The Esmolol arm is defined as a 48-hour intravenous infusion of esmolol (Brevibloc 20mg/ml), which will be started on enrollment. The infusion rate will begin at 50 micrograms/kg/min and be adjusted to achieve heart rates between 80 and 100 beats/min with standard dosing regimens used in our Neuro intensive care unit. The infusion will be started at a rate of 0.05 milligrams/kg/min (50 micrograms/kg/min) for 5 minutes. After the 5 minutes of initial infusion, maintenance infusion may be continued at 0.05 mg/kg/min or increased stepwise (e.g. 0.1 mg/kg/min, 0.15 mg/kg/min to a maximum of 0.2 mg/kg/min) with each step being maintained for 4 or more minutes until the target heart rate is achieved.
16206520|NCT01343329|Drug|Propranolol|The comparison arm will be comprised of oral propranolol, starting with 20mg PO every 6 hours prn (as needed) to reduce heart rate into target range. If 20mg is ineffective, the dose will be doubled at each dosing interval until an adequate dose is found, not to exceed 120mg four times daily. (ex: 20mg, 40mg, 80mg, 120mg)
16206521|NCT01343316|Device|Transpyloric feeding tubes (Nasogastric Tube (NG tube), Tiger2, Syncro BlueTube)|To determine the benefits of utilizing one type of transpyloric tube over another.
16206525|NCT01343303|Drug|JNJ-39439335|2 x 5 mg tablets once daily for 21 days
16206526|NCT01343290|Drug|Canagliflozin|Type = 1, unit = mg, number = 300, form = tablet, route = oral use. Single tablet taken with or without a meal during 2 treatment periods
16206527|NCT01343277|Drug|Trabectedin|Type=exactly number, unit=mg/m2, number=1.5, form=intravenous infusion, route=intravenous use. Once every 3 weeks until disease progression or signs of toxicity.
16206528|NCT01343277|Drug|Dacarbazine|Type=exactly number, unit=g/m2, number=1, form=intravenous infusion, route=intravenous use. Once every 3 weeks until disease progression or signs of toxicity.
16206529|NCT01343238|Behavioral|Diet|12 week diet behavior modification
16206530|NCT01343238|Behavioral|Exercise|12 week exercise behavioral intervention
16206531|NCT01343238|Behavioral|Diet and Exercise|12 week diet and exercise behavioral modification intervention
16206532|NCT01343225|Drug|atripla|once a day
16206533|NCT01343225|Drug|darunavir ritonavir raltegravir|as directed
16206534|NCT01343212|Other|stiffness measurement using ARFI|Stiffness measurement will be performed for HCC using ARFI technique.
16206535|NCT01343186|Drug|Peginterferon alfa|s,c, 45mcg of Ypeginterferon alfa-2a
16206536|NCT01343186|Drug|Peginterferon alfa 2a|s,c, 90mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.
16206537|NCT01343186|Drug|Peginterferon alfa-2a|s,c, 180mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.
16206538|NCT01343186|Drug|Peginterferon alfa-2a|s,c, 270mcg of Ypeginterferon alfa-2a or 180mcg of Pegasys.
16206539|NCT01343173|Drug|Imatinib stop|To stop imatinib after inclusion.
16206540|NCT01343160|Device|GORE® VIABIL® Biliary Endoprosthesis|Deployment of GORE® VIABIL® Biliary Endoprosthesis to the area of stricture
16206541|NCT01343147|Other|Microwave diathermy|Deep tissue heating via microwave diathermy
16206542|NCT01343147|Other|Superficial hyperthermia|Superficial heating via hot pack application
16206543|NCT01343134|Device|Measure the outer retina by spectral domain optical coherence tomography (HRA Spectralis; Heidelberg), and microperimetry (OPKO Instruments)|Measure the thickness of the outer retina by spectral domain optical coherence tomography (HRA Spectralis; Heidelberg)and perform central microperimetry using new OPKO Instruments OCT.
16206544|NCT01343121|Other|sample collection|Blood samples will be collected on days 1, 8, 15 and 22. They will be taken 30 minutes and 2 hours post Gemcitabine infusion.
16206545|NCT01343121|Other|sample collection|Urine will be collected on days 1, 8, 15 and 22. They will be taken pre gemcitabine and 2 hours post Gemcitabine
16206546|NCT01343121|Other|Sample Collection|Quality of Life (QOL) questionnaires given to the patient at each visit
16206547|NCT01343095|Device|Foam Earplugs|Standard Foam Earplugs applied from 10pm-6am nightly. (Sperian Technologies, manufacturer)
16206548|NCT01343095|Device|Noise Canceling Headphones|Noise Canceling headphones applied over the ears between 10pm-6am nightly. Model is Bose QuietComfort 15, manufactured by Bose Technologies.
16206549|NCT01343082|Drug|DE-111 ophthalmic solution|
16206550|NCT01343069|Procedure|implementation surgical checklist|a checklist according to the suggestions raised by the WHO is implementated
16206551|NCT01343056|Behavioral|Office Staff Support|The intervention includes the Office staff of primary care practices trained to provide diabetes support for behavioral goal setting were tasked to follow up with patients via phone following completion of diabetes self-management education.
16206552|NCT01343056|Behavioral|Peer Support|Community peers trained to provide diabetes support for behavioral goal setting were tasked to follow up with patients via phone following completion of diabetes self-management education.
16206553|NCT01343056|Behavioral|Usual Care Support|Diabetes educators provided patient follow up for behavioral goal setting support according to traditional clinical guidelines following completion of diabetes self-management.
16206554|NCT01343056|Behavioral|Educator Support|Diabetes educators provided patient follow up for behavioral goal setting support that was problem-focused and patient centered.
16206555|NCT01343043|Drug|NY-ESO-1(c259)T Cells|Lymphodepleting chemotherapy followed by infusion with NY-ESO-1(c259) transduced autologous T cells. Subjects will receive one infusion of NY-ESO-1 genetically engineered T cells on Day 0.
16206556|NCT01343043|Drug|Fludarabine|Fludarabine will be used as lymphodepleting chemotherapy.
16206557|NCT01343043|Drug|Cyclophosphamide|Cyclophosphamide will be used as lymphodepleting chemotherapy.
16206558|NCT01343017|Other|Ventilatory pattern|In group one, increased tidal volume with a adjusted apparatus dead space volume (IVT), In group two, normal tidal volume with a PEEP to 10 cmH2O applied(NVT). PETCO2 will be adjusted to maintain at 4.5 kPa, in both groups. When PETCO2 values were stable at 4.5 kPa, sevoflurane administration will be started with a vaporiser set to 3%. After 5 minutes the fresh gas flow will be adjusted to 1.0 L/min with an unchanged vaporiser setting throughout the anaesthesia period.
16206559|NCT01343004|Drug|Placebo|Placebo 0 mcg subcutaneous daily
16206560|NCT01343004|Drug|BA058 80 mcg|BA058 80 mcg subcutaneous daily
16206561|NCT01343004|Drug|teriparatide|teriparatide 20 mcg subcutaneous daily
16206562|NCT01342991|Procedure|Laser Haemorrhoidectomy|"The intervention comprises laser haemorrhoidectomy
~This procedure will be performed under local anaesthetic with sedation as a day case
~The haemorrhoids are excised using sharp dissection (over a clamp) and the cut edges are sealed using CO2 laser.
~Pre-operative local anaesthesia will be given"
16206563|NCT01342991|Procedure|Laser Haemorrhoidectomy|"The intervention comprises laser haemorrhoidectomy
~This procedure will be performed under local anaesthetic with sedation as a day case
~The haemorrhoids are excised using sharp dissection (over a clamp) and the cut edges are sealed using CO2 laser.
~Pre-operative local anaesthesia will be given"
16206564|NCT01342965|Drug|Erlotinib|Erlotinib was supplied as tablets.
16206565|NCT01342965|Drug|Chemotherapy|Cisplatin and gemcitabine were locally sourced with commercial products.
16206566|NCT01342952|Drug|Ambrisentan|open label, flexible dosing from 2.5 to 10 mg (not to exceed 10 mg/kg) per day
16206567|NCT01342939|Other|Oral Glucose Tolerance Test (OGTT)|50g waterfree glucose dissolved in 300ml water consumed over 5 min.
16206568|NCT01342939|Other|iso glycaemic intravenous (iv) glucose infusion (IIGI)|20% glucose
16206569|NCT01342939|Dietary Supplement|Meal test|Energy drink, 350ml (525 kcal: 65 g carbohydrates, 20 g fat and 21 g protein)
16206698|NCT01342146|Drug|pegylated Somatropin|0.1 mg/kg/wk once a week for 25 weeks
16206570|NCT01342939|Other|Sitagliptin|Healthy control subject are given an acute dosage of 100mg the evening before the experimental day, and the same morning in order to increase levels of endogen incretin hormones
16206571|NCT01342939|Other|Incretin effect on sulphonyl urea treatment|Subject with MODY who are treated with sulphonyl urea are investigated without medication break prior to examination.
16206572|NCT01342926|Drug|GSK933776|GSK933776
16206573|NCT01342926|Drug|Placebo|Placebo
16206574|NCT01342913|Drug|Fluticasone Furoate 100mcg/Vilanterol 25mcg|Inhalation Powder
16206575|NCT01342913|Drug|Fluticaosne Propionate 500mcg/Salmeterol 50mcg|Inhalation Powder
16206576|NCT01342900|Device|connected to the InSpectra Monitor|
16206577|NCT01342887|Drug|cyclosporine|Given IV
16206578|NCT01342887|Drug|pravastatin sodium|Given PO
16206579|NCT01342887|Drug|mitoxantrone hydrochloride|Given IV
16206580|NCT01342887|Drug|etoposide|Given IV
16206581|NCT01342887|Procedure|bone marrow aspiration|Correlative studies
16206582|NCT01342874|Dietary Supplement|Inositol|inositol exposure in early GDM
16206583|NCT01342861|Dietary Supplement|Addition of protein (milky food in the breakfast)|The main purpose of this study is to evaluate the efficacy of additional protein (adding milky food to the breakfast) in order to deliver an optimized protein and energy intake of 15.75 g and 559 Kcal, respectively.
16206584|NCT01342835|Drug|Propofol|The induction dose of propofol is 3-5 mg/kg-1 (mean induction dose: 4 mg/kg-1) follow by propofol infusion (12 mg/kg/h-1 for the first 10 min of general anesthesia, 9 mg/kg/h-1 for another 10 min, and 6 mg/kg/h-1 thereafter; mean maintenance dose: 9 mg/kg/h-1) and a 50:50 mixture of N2O and O2.
16206585|NCT01342822|Device|Angioplasty (PROMUS Element™, and Xience™ Prime stent)|Patients with symptomatic ischemic heart disease due to stenotic lesions amenable to percutaneous treatment with a drug eluting stent in a consecutive unselected patient population, provided that the proposed research use of the product is consistent with the approved (labeled) uses of such product and with the reimbursed indications (in countries where reimbursement procedure applies, eg France) and does not violate any other applicable law, regulation or ethical directive/code.
16206586|NCT01342809|Behavioral|Follow up|Follow up, consultations with general practitioner, written guidelines, supervision.
16206587|NCT01342796|Biological|MF59C.1-adjuvanted subunit influenza vaccine|2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm
16206588|NCT01342796|Biological|Sub unit, Inactivated, Influenza vaccine|2 x 0.25 ml doses administered intramuscularly in the deltoid muscle of (preferably) the non dominant arm
16206589|NCT01342783|Genetic|DNA analysis|
16206590|NCT01342783|Genetic|RNA analysis|
16206591|NCT01342783|Genetic|mutation analysis|
16206592|NCT01342783|Genetic|nucleic acid sequencing|
16206593|NCT01342783|Other|laboratory biomarker analysis|
16206594|NCT01342770|Other|Laboratory Biomarker Analysis|Correlative studies
16206595|NCT01342770|Drug|Pioglitazone Hydrochloride|Given PO
16206596|NCT01342770|Other|Quality-of-Life Assessment|Ancillary studies
16206597|NCT01342757|Drug|vorinostat|Given orally
16206598|NCT01342757|Drug|temozolomide|Given orally
16206599|NCT01342757|Procedure|magnetic resonance spectroscopic imaging|Undergo MRI
16206600|NCT01342757|Other|survey administration|Ancillary studies
16206601|NCT01342744|Drug|Metformin|Metformin(850 mg) 1tab oral twice aday
16206602|NCT01342744|Drug|Placebo|Placebo 1 tab oral twice a day
16206603|NCT01342731|Drug|Tigecycline|100 mg of tigecycline intravenous infusion for 30 minutes followed by 50 mg every 12 hours for 7 to 14 days.
16206604|NCT01342718|Dietary Supplement|Herbal extract granule and probiotics|"The herbal extract granule, Gwakhyangjeonggisan granule, consists of 11 herbs. Ingredients: Agastachis, Perillae Folium, Angelicae Radix, Arecae Pericarpium, Hoelen, Magnoliae officinalis Cortex, Atractylis Rhizoma, Aurantii nobilis Percarpium, Pinelliae Rhizoma, Platycodi Radix, Glychrrhizae Radix. Dosage and frequency: 1 pack (3g), 3 packs per day (2 hours after morning, afternoon and evening meal)
~The probiotics, Duolac7S, consist of 7 bacteria. Ingredients: Lactobacillus acidophilus, L. plantarum, L. rhamnosus, Bifidobacterium breve, B. lactis, B. longum, Streptococcus thermophilus. Dosage and frequency: 1 capsule (5✕1,000,000,000 bacteria/capsule [7✕100,000,000 viable cells/strain]), 2 capsules per day (2 hours after morning and evening meal)"
16206605|NCT01342718|Dietary Supplement|Herbal extract granule and placebo probiotics|"The herbal extract granule, Gwakhyangjeonggisan granule, consists of 11 herbs. Ingredients: Agastachis, Perillae Folium, Angelicae Radix, Arecae Pericarpium, Hoelen, Magnoliae officinalis Cortex, Atractylis Rhizoma, Aurantii nobilis Percarpium, Pinelliae Rhizoma, Platycodi Radix, Glychrrhizae Radix. Dosage and frequency: 1 pack (3g), 3 packs per day (2 hours after morning, afternoon and evening meal).
~Duolac7S placebo has the same form, color and flavor as experimental intervention (Duolac7S). The dosage, frequency and duration is also the same as experimental intervention (Duolac7S)."
16206606|NCT01342718|Dietary Supplement|Placebo herbal extract granule and probiotics|"The Gwakhyangjeonggisan placebo has the same form, color and flavor as experimental intervention (Gwakhyangjeonggisan). The dosage, frequency and duration is also the same as experimental intervention (Gwakhyangjeonggisan).
~The probiotics, Duolac7S, consist of 7 bacteria. Ingredients: Lactobacillus acidophilus, L. plantarum, L. rhamnosus, Bifidobacterium breve, B. lactis, B. longum, Streptococcus thermophilus. Dosage and frequency: 1 capsule (5✕1,000,000,000 bacteria/capsule [7✕100,000,000 viable cells/strain]), 2 capsules per day (2 hours after morning and evening meal)"
16206607|NCT01342718|Dietary Supplement|Placebo herbal extract granule and placebo probiotics|"The Gwakhyangjeonggisan placebo has the same form, color and flavor as experimental intervention (Gwakhyangjeonggisan). The dosage, frequency and duration is also the same as experimental intervention (Gwakhyangjeonggisan).
~Duolac7S placebo has the same form, color and flavor as experimental intervention (Duolac7S). The dosage, frequency and duration is also the same as experimental intervention (Duolac7S)."
16206608|NCT01342705|Procedure|phlebotomy|Procedure: Phlebotomy of 4 ml / kg to obtain (1 phlebotomy every 14 days) and maintain (1 phlebotomy every 3 months) a serum ferritin below 50 µg / l.
16206609|NCT01342692|Drug|Azacitidine|6 cycles of Azacitidine 75 mg/m2 subcutaneously daily for 7 days, every 4 weeks The first course will be started on day 1 regardless of the blood count. Subsequent courses will be scheduled every 4 weeks
16207232|NCT01338129|Drug|placebo|placebo pills
16206610|NCT01342692|Drug|Azacitidine associated with Valproic acid|"6 cycles of Azacitidine 75 mg/m2 subcutaneously daily for 7 days, every 4 weeks Valproic Acid (Depakine-Chrono®) (VPA) will be administered concomitantly for a minimum of 6 cycles.
~- In patients aged 60 years or less: VPA (25 mg/kg twice a day i.e. 50 mg/kg/d) administered orally, daily for 7 days (days 1-7)
~- In patients older than 60 years: VPA (17.5 mg/kg twice a day i.e. 35 mg/Kg/d) administered orally daily for 7 days (days 1-7)"
16206611|NCT01342692|Drug|Azacitidine associated with Lenalidomide|"6 cycles of Azacitidine 75 mg/m2 subcutaneously daily for 7 days, every 4 weeks Lenalidomide (Revlimid®) will be administered once daily orally as continuous schedule started on day 1 of Azacitidine.
~Patients will receive Lenalidomide 10 mg/d, during 14 days (D1 to D14)"
16206612|NCT01342692|Drug|Azacitidine associated with Idarubicine|Azacitidine (Vidaza®) will be administered similarly to group 1 exposed above. Idarubicin (Zavedos®) as the reconstituted solution, will be administered slowly by the intravenous route over 60 minutes at 10 mg/m²of body-surface area on day 8 of Azacitidine or day 10 if azacitidine was administered according to (5-2-2 regimen)
16206613|NCT01342679|Drug|dasatinib|100mg QD
16206614|NCT01342666|Dietary Supplement|Tomato consumption|Daily consumption of 300g of uncooked roma tomatoes during one month.
16206615|NCT01342666|Dietary Supplement|Cucumber consumption|Daily consumption of 300g of cucumber.
16206616|NCT01342653|Other|Intraperitoneal and systemic chemotherapy plus maximum cytoreduction plus HIPEC|see Design
16206617|NCT01342640|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|Recommended starting dose 1.2 micrograms/kg subcutaneously every 4 weeks (depending on patient's weight). Dose adjustment may be required in the event of inadequate or excessive treatment response.
16206618|NCT01342627|Drug|Sorafenib|"Sorafenib will be orally administered at a daily dose of 400 mg taken twice daily without food, at least one hour before or two hours after eating. Four weeks of treatments will be considered as a cycle. Each patient enrolled in the study will received medications for topical therapy. Dermatological medications will be provided free.
~In case of toxicities, dose reduction/interruption is permitted according to the protocol.
~In case of disease progression Sorafenib administration will be discontinued."
16206619|NCT01342614|Drug|Fosinopril|Fosinopril group received fosinopril, 10mg, once per day.
16206620|NCT01342614|Drug|Metformin|Metformin group was treated with metformin hydrochloride, 500mg, three times per day
16206621|NCT01342601|Device|ect4allergy Nasal Spray (ANS01) and Eye Drops (AAT01)|Comparison of ANS01 and AAT01 with placebo
16206622|NCT01342601|Device|Placebo products|Nasal Spray and Eye drops without Ectoin
16206623|NCT01342588|Procedure|Electric pulse train stimulation|Electric pulse train stimulation of regular probes and screw drivers used in track creation and screw placement Using a standard neurophysiological work station, a series of square wave pulses will be delivered through standard probes and screw drivers using an alligator clip during pedicle probing and screw insertion (4 Hz for 50-200 μsec at 10-30 μAmp)
16206624|NCT01342575|Procedure|Intra-operative exposure maneuvers|"Feet compression maneuver: Taking feet from the ankles, gentle pressure will be applied toward the cranium and maintained for 1 minute. X-rays and IONM will be performed
~Arm traction maneuver: Holding two strips around the wrists and using a dynamometer adjusted to 8 kg per side, sustained traction will be maintained for 1 minute. X-rays and IONM will be performed.
~Shoulder taping maneuver: Both shoulders will be pulled caudally with adhesive tape adjusted for a tension of 8 kg on each side. X-rays and IONM will be performed
~Arm traction plus feet compression maneuvers: Simultaneous combination of both maneuvers as described before. X-rays and IONM will be performed
~Shoulder taping plus feet compression maneuvers: Simultaneous combination of both maneuvers as described before. X-rays and IONM will be performed"
16206625|NCT01342562|Drug|spinal anesthesia|0.4% bupivacaine(normal saline 0.3ml with dexmedetomidine 3 mcg)
16206626|NCT01342562|Drug|spinal anesthesia|0.4% bupivacaine(normal saline 0.3 ml with 0.5% bupivacaine 1.2 ml)
16206627|NCT01342549|Drug|Valproate|250mg per day 30 minutes after a meal. Dosages will be increase as tolerated to a maximum recommended dosage of 60 mg per kg per day. Usual dosage is between 1250mg to 2000mg per day
16206628|NCT01342549|Drug|Naltrexone|25mg per day, taken by mouth for 7 days, then 50mg per day
16206629|NCT01342536|Behavioral|Coping with Depression Course (CWD) and Oh Happy Day Class (OHDC)|"The OHDC is a culturally adapted, cognitive behavioral group counseling intervention. The OHDC is theoretically grounded in social learning theory and an Afrocentric paradigm (Nguzo Saba). It uses a social support group and psychoeducation format so participants learn skills to help them in coping and reducing symptoms of depression. The OHDC is offered over 13 weeks with 2-hour sessions in a clinical setting.
~The CWD, an evidence-based cognitive behavioral depression intervention. The CWD is offered over 8 weeks with 2-hour sessions in a clinical.
~Arms: lifestyle counseling (OHDC), lifestyle counseling (CWD)"
16206630|NCT01342523|Other|CIS - telephone cessation quitline counseling|Up to 5 total tobacco cessation counseling calls
16206631|NCT01342523|Other|Lozenge - nicotine mini-lozenges|2-week starter pack of nicotine mini-lozenges
16206632|NCT01342523|Other|Emails - Brief smoking prevention messages|Brief email messages that could be accessed by any computer or mobile device that allowed email receipt
16206633|NCT01342523|Other|Full website - standard smokefree.gov website content|Over 50 web pages of resources for quitting smoking, including interactive features and referral links
16206634|NCT01342523|Other|Lite website - lite version of smokefree.gov|Reduced version of the smokefree.gov website developed for the research; reduced number of web pages and external links (considered a placebo intervention)
16206635|NCT01342523|Other|Full mailed booklet - NCI's detailed 36-page quit guide|NCI's Clearing the Air brochure for preparing to quit, quitting and preventing relapse
16206636|NCT01342523|Other|brief mailed booklet - smaller version of NCI's booklet|12-page booklet developed by the investigators for the research (considered to be placebo intervention)
16206637|NCT01342510|Drug|Magnesium Sulfate|We propose studying Lidocaine 50 mg in a 10 cc syringe, Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe, 0.9% saline in a 10 cc syringe, Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe for pretreatment of propofol related pain on injection.
16206638|NCT01342510|Drug|Lidocaine|We propose studying Lidocaine 50 mg in a 10 cc syringe, Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe, 0.9% saline in a 10 cc syringe, Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe for pretreatment of propofol related pain on injection.
16206639|NCT01342510|Drug|Control|We propose studying Lidocaine 50 mg in a 10 cc syringe, Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe, 0.9% saline in a 10 cc syringe, Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe for pretreatment of propofol related pain on injection.
16206640|NCT01342510|Drug|Lidocaine/Magnesium|We propose studying Lidocaine 50 mg in a 10 cc syringe, Magnesium sulfate 0.25 g (2 mOsmol) in a 10 cc syringe, 0.9% saline in a 10 cc syringe, Lidocaine 50 mg and 0.25 g (2 mOsmol) magnesium sulfate in a 10 cc syringe for pretreatment of propofol related pain on injection.
16206641|NCT01342497|Drug|isoniazide|Tablets, dosing 3 times daily, 12 weeks
16206642|NCT01342497|Drug|placebo|tablets, dosing 3 times daily, 12 weeks
16206643|NCT01342484|Drug|placebo|comparison of different dosages of drug (low vs high) vs placebo
16206644|NCT01342484|Drug|BI1356 low dose|comparison of different dosages of drug (low vs high) vs placebo
16206645|NCT01342484|Drug|BI1356 high dose|comparison of different dosages of drug (low vs high) vs placebo
16206646|NCT01342471|Behavioral|TV commercial stepping|"Participants were instructed to stand and briskly step in place, or briskly walk continuously around the room/house for the duration of each commercial break during at least 90 min of TV programming on at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
16206647|NCT01342471|Behavioral|30-min walk|"Participants were instructed to use brisk walking (at least 30 min/day in bouts of at least 10 min) at least 5 days/week. Both conditions will receive an ankle mounted Omron pedometer, so they were able to track their steps each day. Participants were not given instructions concerning diet modification or modifying TV viewing time during a 6 month behavioral physical activity intervention"
16206648|NCT01342458|Other|Flexible footwear|The patients of the Intervention Group (IG) will be use over 6 month a flexible and non-heeled footwear (Moleca; Calçados Beira Rio S.A., Novo Hamburgo, Rio Grande do Sul, Brazil) is a women's flexible flat walking shoe, without heels, with an anti-slip rubber sole, 5-mm thin, with a 3 mm internal wedge of ethylene vinyl acetate, made out of dubbed canvas. It had a mean weight of 172 ± 19.6 g, ranging from 142 to 193 g depending upon the size.
16206649|NCT01342445|Drug|lisdexamfetamine dimesylate|30-mg, 50-mg, 70-mg administered for one week in context of double-blind, placebo-controlled crossover design
16206650|NCT01342445|Drug|Placebo|
16206651|NCT01342432|Other|General exercise only|exercises for stretch and strength of paraspinal and abdominal muscles
16206652|NCT01342432|Other|Balance reeducation plus general exercise|patients perform balance reeducation exercises in addition to general exercises for stretch and strength of back and abdominal muscles
16206657|NCT01342354|Radiation|Stereotactic Radiation|Escalating Doses of SBRT in periods of three doses over 10 days
16206658|NCT01342341|Drug|Parafon Forte|"Drug: Parafon Forte administered at study visit
~Other: Placebo administered at study visit"
16206659|NCT01342328|Other|Normal saline infusion|Normal saline infusion
16206660|NCT01342328|Drug|Dexmedetomidine|"Infusion of Dexmedetomidine will be administrated during the overnight sleep study. An initial target concentration of 0.25 ng/ml will be selected. After 5 min, the sedative point will be assessed and the concentration will be adjusted stepwise by increments and decrements of 0.05 ng/ml. This process will be repeated until the target sedative state is achieved. Using the Richmond Agitation Sedation Scale (RASS) infusion rates, using known pharmacokinetic parameters will be adjusted to achieve equivalent levels of sedation (RASS -3) for both DEX and propofol sessions.
~We aim to achieve an RASS of -3 so that the subjects are moderately sedated. This state of sedation will be maintained for 3-4 hours."
16206661|NCT01342328|Drug|Propofol|"For propofol, an initial concentration of 0.75 ng/ml will be targeted. Depending on the score achieved, the infusion rate will be increased or decreased every 5 min by 0.2 ng/ml until the target sedative state is achieved.
~Note that the target sedative state (RASS score of -3) is the same for both DEX and propofol sessions, with the investigator being unaware of which drug is being administered. To ensure the investigator is not aware of the type of drug being administered, all drug delivery systems will be covered.
~Intravenous drug delivery will be continued throughout the scanning period for 3-4 hours to maintain equivalent levels of sedation for both DEX and propofol."
16206662|NCT01342315|Drug|33525|Daily dosing
16206663|NCT01342315|Drug|Placebo|Daily dosing
16206664|NCT01342302|Behavioral|Psychosocial Intervention for Couples|Intervention delivered on line
16206665|NCT01342289|Drug|Cyclophosphamide|Days -6 and -5: 14.5 mg/kg/day IV. Days 3 and 4: 50 mg/kg/day IV.
16206666|NCT01342289|Drug|Fludarabine|Days -6, -5, -4, -3, and -2: 30 mg/m^2/day IV.
16206667|NCT01342289|Radiation|Total body irradiation|Day -1: 200 centigray in one fraction.
16206668|NCT01342289|Drug|Mycophenolate Mofetil|Days 5 to 35: 15 mg/kg PO three times per day; max daily dose 1 g.
16206669|NCT01342289|Drug|Tacrolimus 60|Begin dosing at 1 mg IV daily on Day 5. Dose is titrated according to serum levels. Stop at Day 60.
16206670|NCT01342289|Drug|Tacrolimus 90|Begin dosing at 1 mg IV daily on Day 5. Dose is titrated according to serum levels. Stop at Day 90.
16206671|NCT01342289|Drug|Tacrolimus 120|Begin dosing at 1 mg IV daily on Day 5. Dose is titrated according to serum levels. Stop at Day 120.
16206672|NCT01342289|Biological|Bone marrow transplant|Donor stem cells infused IV on Day 0.
16206699|NCT01342146|Drug|pegylated Somatropin|0.2 mg/kg/wk once a week for 25 weeks
16206700|NCT01342146|Drug|Jintropin AQ|0.25 mg/kg/wk, once a day for 25 weeks
16206673|NCT01342276|Behavioral|vHFC|Common practice for managing HF patients attending urban-based, specialized HF clinics is to have them weigh themselves daily and report any dramatic fluctuations and/or increasing symptoms to their clinic. We have transformed this model to the vHFC website such that each day, participants will logon to the vHFC and enter their weight and answer six questions regarding their current symptoms. An alert will be generated if the participant enters data outside of the desired parameters, does not enter their data for three consecutive days, or enters a comment in the text box for the vHFC nurse to view. If an alert is generated, following participant data entry, the participant is presented with a pop up window to inform them that the vHFC nurse will contact them within 24 hours. The nurse will contact the participant by telephone to discuss the alert generated and provide counselling.
16206674|NCT01342263|Behavioral|iCDM|The iCDM intervention will be managed by a nurse with experience in chronic disease management who will review patient data, communicate with the patients, implement the Treatment Algorithms and interact with the patients' PCP. Patients will also be able to interact with a dietitian and exercise specialist to support them in their disease management. These personnel will have formal training in principles of the Transtheoretical Model of Change and Social Cognitive Theory.
16206675|NCT01342250|Biological|conventional therapy plus low dose hUC-MSCs treatment|patients will receive the conventional therapy plus low dose hUC-MSCs treatment
16206676|NCT01342250|Biological|conventional therapy plus medium dose hUC-MSCs treatment|patients will receive conventional therapy plus medium dose hUC-MSCs treatment
16206677|NCT01342250|Biological|conventional therapy plus high dose hUC-MSCs treatment|patients will receive conventional therapy plus high dose hUC-MSCs treatment
16206678|NCT01342237|Drug|HDCT 1(TTC), HDCT2(MEC)|"TTC Topotecan (2 mg/m2 once daily i.v. on days -8, -7, -6, -5, -4) Thiotepa (300 mg/m2 once daily i.v on days -8, -7, -6) Carboplatin (500 mg/m2 once daily i.v on days -5, -4, -3) (max. 700 mg/day)
~MEC Melphalan (140 mg/m2 once daily i.v on day -7, 70 mg/m2 once daily i.v on day -6) Etoposide (200 mg/m2 once daily i.v on days -8, -6) Carboplatin (350 mg/m2 once daily i.v on days -8, -7, -6, -5)"
16206679|NCT01342224|Biological|tadalafil and vaccination|Participants receive a 4-week course of vaccination with telomerase vaccine and GM-CSF by injection, along with a cycle of gemcitabine chemotherapy (IV). This is followed by radiation and gemcitabine given twice weekly then by another dose of vaccine. Four weeks after completion of chemotherapy and radiation, participants able to have surgical treatment will have surgery followed by vaccination and chemotherapy. Participants with stable or responsive disease that cannot be treated by surgery will have vaccination and chemotherapy with 2 cycles of telomerase vaccine with GM-CSF along with gemcitabine. Participants with unresectable and progressive disease after administration of vaccine, chemotherapy and radiation treatment may transition to vaccination and chemotherapy treatment.
16206680|NCT01342211|Biological|Placebo|Intravenous placebo monthly during treatment phase.
16206681|NCT01342211|Drug|Statin|Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.
16206682|NCT01342211|Biological|PF-04950615 (RN316)|Intravenous 10mg/mL based on weight monthly during treatment phase.
16206683|NCT01342211|Drug|Statin|Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.
16206684|NCT01342211|Biological|PF-04950615 (RN316)|Intravenous 10mg/mL based on weight monthly during treatment phase.
16206685|NCT01342211|Drug|Statin|Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.
16206686|NCT01342211|Biological|PF-04950615 (RN316)|Intravenous 10mg/mL based on weight monthly during treatment phase.
16206687|NCT01342211|Drug|Satin|Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.
16206688|NCT01342211|Biological|PF-04950615 (RN316)|Intravenous 10mg/mL based on weight monthly during treatment phase.
16206689|NCT01342211|Drug|Statin|Single daily dose of atorvastatin (40 or 80 mg), rosuvastatin (20 or 40 mg) or simvastatin (40 or 80 mg) from Day 1 to Day 141/ET.
16206690|NCT01342198|Drug|Pregabalin controlled release, 330 mg|A single oral dose of 330 mg controlled release tablet
16206691|NCT01342198|Drug|Pregabalin controlled release, 330 mg|A single oral dose of 330 mg controlled release tablet
16206692|NCT01342198|Drug|erythromycin|A total of three doses of 500 mg erythromycin ethylsuccinate tablets administered six hours apart beginning approximately 1 hour prior to pregabalin CR
16206693|NCT01342185|Device|medical ozone therapy with tianyi|Medical ozone therapy with instrument made in China Patients in this arm will receive autohemotherapy. First month: ozone concentration: 20µg ~40µg /ml;The second month: 30µg/ml × 100ml oxygen- ozone gas × 100 ml blood;The third month: 20µg/ml × 100ml oxygen- ozone gas× 100 ml blood.
16206694|NCT01342185|Device|medical ozone therapy with humares|Medical ozone therapy with instrument made in Germany Patients in this group will receive autohemotherapy treatment, regime as ArmⅠ.
16206695|NCT01342185|Drug|Diammonium glycyrrhizinate Capsules|Drug: Diammonium glycyrrhizinate Capsules Patients in this group will receive oral Diammonium glycyrrhizinate Capsules 150mg, three times a day for 12 weeks.
16206696|NCT01342172|Drug|Lenalidomide|"Patients will receive gemcitabine 1000 mg/m2 IV on days 1 + 8 and cisplatin 70 mg/m2 IV on day 1 of each 21 day cycle. Lenalidomide will be given orally on days 1-14 and the dose will be escalated in successive cohorts during the phase Ib portion to define the recommended phase II dose. Patients will continue gemcitabine, cisplatin, plus lenalidomide for up to 6 cycles, in the absence of disease progression or prohibitive toxicity. After completion of 6 cycles of therapy, patients who have achieved at least stable disease will proceed with maintenance lenalidomide given orally on days 1-21 of each 28-day cycle. Treatment will continue, in the absence of prohibitive toxicity, until the time of disease progression."
16206697|NCT01342159|Procedure|Intravitreal injection|Intravitreal Injections were done under sterile conditions with topical anesthesia and insertion of a lid speculum. For the bevacizumab group, 1.25 mg (0.05 cc) bevacizumab (Avastin, made for F. Hoffmann-La Roche Ltd Basel, Switzerland by Genentech Inc., San Francisco, CA, USA) was injected intravitreally with a 30-gauge needle through the superotemporal quadrant. For the bevacizumab with triamcinolone group, in addition to intravitreal bevacizumab, 2 mg(0.05 cc) triamcinolone acetonide (Triamhexal, Hexal AG,Holzkirchen, Germany) was injected intravitreally through the inferotemporal quadrant. For triamcinolone group, 2 mg (0.05 cc) triamcinolone acetonide (Triamhexal, Hexal AG,Holzkirchen, Germany) was injected intravitreally.
16206701|NCT01342107|Device|FID 114675A multi-purpose disinfecting solution (MPDS)|Investigational multi-purpose disinfecting solution intended for use as a cleaning, reconditioning, rinsing, disinfecting, and storage solution for silicone hydrogel and soft contact lenses.
16206702|NCT01342107|Device|Soft contact lens|Soft hydrogel or silicone hydrogel contact lens matching subject's pre-study lens, including parameters, worn 16 hours on day of dispense.
16206703|NCT01342107|Device|Blister pack solution|Commercially approved storage solution as found in the contact lens blister pack.
16206704|NCT01342094|Drug|DE-111 ophthalmic solution|
16206705|NCT01342094|Drug|Timolol ophthalmic solution 0.5%|
16206706|NCT01342094|Drug|Placebo ophthalmic solution|
16206707|NCT01342081|Drug|DE-111 ophthalmic solution|
16206708|NCT01342081|Drug|Tafluprost ophthalmic solution 0.0015%|
16206709|NCT01342081|Drug|Concomitant use of tafluprost ophthalmic solution 0.0015% plus timolol ophthalmic solution 0.5%|
16206710|NCT01342055|Drug|Apetrol ES|sequences of administered drugs
16206711|NCT01342042|Biological|rExenatide-4|This protein of 39 amino acids has been isolated from the venom of the lizard Heloderma suspectum (Gila monster) (Eng et al, 1992). A mammalian homolog does not seem to exist (Pohl and Wank, 1998). Exendin-4 shares 53 % identity at the amino acid level with that of the mammalian hormone GLP-1 [glucagon-like peptide-1] (Chen and Drucker, 1997). Exendin-4 is encoded within a prohormone that is distinct from the prohormone encoding glucagon. Using transgenic mice expressing exendin-4, Adatia et al (2002) have shown that mammalian cells process the lizard prohormone in endocrine and nonendocrine cell types in vitro and in murine tissues in vivo.
16206712|NCT01342029|Drug|Ranolazine|"This drug is approved by the U.S. Food and Drug Administration (FDA) for treatment of chronic angina.
~500-1,000 mg po bid for 2 weeks"
16206713|NCT01342029|Drug|Placebo|500-1,000 mg po bid for 2 weeks
16206714|NCT01342016|Drug|tacrolimus capsule|oral
16206715|NCT01342016|Drug|tacrolimus placebo|oral
16206716|NCT01342016|Drug|leflunomide tablet|oral
16206717|NCT01342016|Drug|leflunomide placebo|oral
16206718|NCT01342016|Drug|prednisone|oral
16206719|NCT01341990|Device|FID 114675A Multi-Purpose Disinfecting Solution (MPDS)|Investigational solution intended for use as a cleaning, rinsing, reconditioning, disinfecting, and storage solution for silicone hydrogel and soft contact lenses
16206720|NCT01341990|Device|ReNu Fresh Lens Comfort Multi-Purpose Solution (MPS)|Commercially marketed prodouct indicated for cleaning, removing protein deposits, rinsing, disinfecting, and storing soft contact lenses
16206721|NCT01341990|Device|Silicone Hydrogel Contact Lenses|Commercially marketed silicone hydrogel contact lenses per habitual prescription for daily wear use, at least 8 hours/day. New pair dispensed at Day 0 (Baseline Visit) and at the conclusion of Day 1 (Visit 2).
16206722|NCT01341977|Device|Alcon MPDS|Multi-Purpose Solution intended for use with silicone hydrogel and soft contact lenses
16206723|NCT01341977|Device|ReNu Fresh MPS|ReNu Fresh MPS is a marketed product indicated for cleaning, removing protein deposits, rinsing, disinfecting and storage of soft contact lenses.
16206724|NCT01341964|Drug|Clopidogrel|600mg (2 pills)
16206725|NCT01341964|Drug|Aspirin|325mg (1 pill)
16206726|NCT01341964|Drug|Aspirin|81mg (1 pill)
16206727|NCT01341951|Drug|Granulocyte colony stimulating factor|300 I.U twice daily for 5 days
16206728|NCT01341938|Drug|Commit® nicotine lozenges (4 mg) & self-help materials|"Participants provided with instructions on standard use of lozenge for nicotine replacement therapy (NRT) & instructed to use the lozenge any time they have a craving or urge to use ST or tobacco. Dosing: weeks 1-6 one lozenge every 1-2 hours/16 per day, weeks 7-9 one lozenge every 2-4 hours/8 per day, weeks 10-12 one lozenge every 4-8 hours/4 per day + The Enough Snuff video and printed guide providing strategies for tobacco cessation."
16206729|NCT01341938|Behavioral|Commit® nicotine lozenges (4 mg) & phone counseling & self-help materials|"Three phone counseling sessions to assist in cessation from use of all tobacco + lozenge nicotine replacement therapy (NRT) + The Enough Snuff video and printed guide providing strategies for tobacco cessation."
16206730|NCT01341938|Behavioral|Phone counseling & self-help materials|"Three phone counseling sessions to assist in cessation from use of all tobacco + The Enough Snuff video and printed guide providing strategies for tobacco cessation."
16206731|NCT01341925|Drug|Omega-3 Supplementation|The Ω3 group will receive 1000 mg Ω3 (two 500 mg capsules, each containing 350 mg EPA: 50 mg DHA; 100 other Ω3) two times daily for a total daily dose of 2000 mg Ω3 (1400 mg EPA: 200 mg DHA; 400 other Ω3). The placebo group will receive two capsules two times daily matched for odor and appearance with the active intervention.
16206732|NCT01341925|Behavioral|Psychoeducational Psychotherapy (PEP)|Therapy sessions occur twice a week for up to 24 sessions of manualized treatment. The importance of separating symptoms from the individual is emphasized. The family is offered support, validation, and recognition for their own difficult experiences in living with the child's mood disorder. Family members are taught that patients are particularly vulnerable to stress and tension; thus, therapists work with families to reduce the level of stress and tension in their homes. Improvement of communication, problem solving and coping strategies can lead to restoration of hope for recovery and decrease family dysfunction. Goals include strengthening the parent-child bond and helping children and parents feel competent to manage depression now and in future recurrences.
16206733|NCT01341925|Other|Placebo|The placebo group will receive active monitoring (no IF-PEP) and two capsules two times daily matched for odor and appearance with the active intervention.
16206734|NCT01341912|Biological|Human-cl rhFVIII|Human-cl rhFVIII is administered intravenously on demand for bleeding episodes and prophylactically in case of surgery. The dosage depends on the severity of the bleeding episodes and the surgery.
16206735|NCT01341899|Procedure|immunosuppression and stem cell transplantation|Hematopoietic stem cells were mobilized with cyclophosphamide (CY, 2.0 g/m2) and granulocyte colonystimulating factor (10 μg/kg per day) and then collected from peripheral blood by leukapheresis and cryopreserved. The cells were infused after conditioning with CY (200 mg/kg) and rabbit antithymocyte globulin (4.5 mg/kg).
16206736|NCT01341886|Drug|Metformin|in case group metformin is added to levothyroxine and levothyroxine is decreased by 30% .in control group levothyroxine is reduced by 30% and no metformin is added to the regimen.
16206737|NCT01341873|Other|educational intervention|Undergo APN FCI
16206738|NCT01341873|Other|psychosocial support for caregiver|Undergo APN FCI
16206741|NCT01341847|Procedure|water method colonoscopy|This technique allow only water infusion (air pump is turned off) through the adaptor on the biopsy channel of colonoscope during insertion since the scope is inserted into the anus until reach the cecum.
16206742|NCT01341847|Procedure|air method colonoscopy|This technique only use usual air insufflation technique during colonoscope insertion and shortening maneuvers.
16206743|NCT01341834|Drug|LBH589 and RAD001|Dose escalation of LBH589 tablets (5 and 10 mg) and RAD001 tablets (2.5, 5 mg and 10mg)
16206744|NCT01341808|Biological|Epaxal Berna (virosomal hepatitis A vaccine)|standard 0.5 mL dose of Epaxal Berna (virosomal hepatitis A vaccine) given at Day 0, Month 6.
16206745|NCT01341782|Drug|paricalcitol|
16206746|NCT01341782|Drug|maxacalcitol|
16206747|NCT01341782|Drug|paricalcitol placebo|
16206748|NCT01341782|Drug|maxacalcitol placebo|
16206749|NCT01341769|Other|Dietary Intervention|
16206750|NCT01341769|Other|Dietary Intervention|
16206751|NCT01341769|Other|Dietary Intervention|
16206752|NCT01341769|Other|Dietary Intervention|
16206753|NCT01341756|Radiation|Palliative Radiotherapy|Palliative Radiotherapy to a total dose of 36Gy in 12 fractions
16206754|NCT01341743|Drug|Entecavir|patients will receive oral entecavir 1mg, daily for 104 weeks.
16206755|NCT01341743|Drug|Entecavir, Adefovir|patients in this arm will receive oral entecavir 1mg daily and adefovir 10mg daily for 104 weeks
16206756|NCT01341743|Drug|Entecavir, Adefovir|patients in this arm will receive oral entecavir 0.5mg daily and adefovir 10mg daily for 104 weeks
16206757|NCT01341730|Drug|Atorvastatin 20mg|20 mg QD for 3 months
16206758|NCT01341730|Drug|Atorvastatin 20 mg + Pioglitazone 30 mg|atorvastatin 20 mg plus pioglitazone 30 mg QD for 3 months
16206759|NCT01341717|Drug|Sitagliptin|100 mg once daily for 6 months
16206760|NCT01341717|Drug|Glimepiride|1 mg/2 mg/3 mg once daily
16206761|NCT01341717|Drug|Metformin|>=1000 mg twice daily
16206762|NCT01341717|Drug|Insulin|TDD > 10 IU once/twice daily
16206763|NCT01341704|Biological|MSP3-LSP/AlOH|"30 µg of test vaccine MSP3-LSP/AlOH, administered by subcutaneous route according to the following schedule:- Primary administration: Three doses administered at 4 weeks interval: D0, D28 (± 2 days), D56 (± 4 days)
~Secondary administration (Boost):
~Year 1: One dose 3 months after the third dose Year 2: Two doses, given exactly one year after the date corresponding to the third dose and the first boost given during Year 1"
16206764|NCT01341704|Biological|Verorab Vaccine|The Verorab rabies vaccine will be given as control for the primary series of the experimental vaccine. It consists of inactivated rabies virus produced in vero cells (Wistar Rabies PM/W138 1503-3M (inactivated). Manufacturer SANOFI PASTEUR SA. Presentation is 0.5 ml per dose in a pre-filled syringe.
16206765|NCT01341704|Other|0.9% NaCl/Normal Saline|0.5 ml per dose; to be given as control for the secondary/booster doses of experimental vaccine
16206766|NCT01341691|Other|chewing gum|single piece of chewing gum containing specified amount of chitosan with or without extender chewed twice daily for 14 days
16206767|NCT01341678|Drug|Lanthanum Carbonate|Diet will be supplemented with 1000mg at each meal
16206768|NCT01341678|Dietary Supplement|NeutraPhos|Diet will be supplemented with NeutraPhos
16206769|NCT01341678|Other|Diet Only|Diet containing 1500mg of phosphorus
16206770|NCT01341652|Biological|pTVG-HP|pTVG-HP (100 µg) with rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
16206771|NCT01341652|Biological|rhGM-CSF|rhGM-CSF (208 µg) administered intradermally (i.d.) biweekly for 6 total doses, then every 3 months to complete a 2-year treatment period
16206772|NCT01341639|Biological|V419|V419 (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Outer Membrane Protein Complex], and Hepatitis B [Recombinant] Vaccine) 0.5 mL intramuscular injection at 2, 3, 4, and 12 months of age.
16206773|NCT01341639|Biological|INFANRIX™ hexa|INFANRIX™ hexa 0.5 mL intramuscular injection at 2, 3, 4, and 12 months of age.
16206774|NCT01341639|Biological|RotaTeq|RotaTeq (pentavalent combination live vaccine of 5 human-bovine reassortant rotavirus strains) 2 mL oral dose at 2, 3, and 4 months of age
16206775|NCT01341639|Biological|Prevenar 13|Prevenar 13 0.5 mL intramuscular injection at 2, 3, 4,and 13 months of age
16206776|NCT01341639|Biological|ProQuad™|ProQuad™ 0.5 mL subcutaneous injection at 12 and 13 months of age
16206777|NCT01341626|Behavioral|Treatment Foster Care (TFCO)|Youth placed individually in well-trained and supervised foster homes. Basic components: (a) daily telephone contact with TFCO parents; (b) weekly foster parent group meetings focused on supervision, training in parenting practices, and support; (c) an individualized behavior management program implemented daily in the home by foster parent; (d) individualized skills training for the youth; (e) family therapy for aftercare family focused on parent management strategies; (f) close monitoring of school attendance, performance, and homework completion; (g) case management to coordinate TFCO, family, peer, and school settings; (h) 24-hour on-call staff availability to TFCO and biological parents; and (i) psychiatric consultation. Services typically last approximately 6 months.
16206778|NCT01341626|Behavioral|Group Care|Group Care is the usual service for youth placed in out-of-home care for chronic delinquency in Oregon. These programs represented typical services for girls being referred to out-of-home care by the juvenile justice system and had 2-51 youth in residence (M = 21) and 1-50 staff members (Mdn = 2); most also had onsite schooling. Although the programs differed somewhat in theoretical orientations, 86% reported that they endorsed a specific treatment model, of which the primary philosophy was a behavioral (70%), eclectic (26%), or family-style therapeutic approach (4%). Services typically last approximately 6 months.
16206779|NCT01341613|Dietary Supplement|Cardioviva™ supplement capsule|Twice per day (BID), 9 weeks
16206780|NCT01341613|Dietary Supplement|Placebo capsule|Twice per day (BID), 9 weeks
16206781|NCT01341600|Drug|Clopidogrel|Over a 6 week period participants will be given: 75 mg of clopidogrel for 8 days, at least 1 week washout, 150 mg of clopidogrel for eight days, at least 1 week washout, 300 mg of clopidogrel for eight days.
16206782|NCT01341600|Drug|Omeprazole/Clopidogrel|After a washout of at least 1 week, participants will have the option to participate in a final intervention in which they will be given 75 mg of clopidogrel together with 20 mg of omeprazole daily for eight days.
16208935|NCT01324596|Drug|Intravenous|Chemoimmunotheraphy
16206783|NCT01341587|Device|Telcare Blood Glucose Meter (BGM)|Cellular enabled glucometer
16206784|NCT01341574|Procedure|Prism adaptation with optical shift of 10 degrees.|Prism adaptation with optical shift of 10 degrees.
16206785|NCT01341574|Procedure|Prism adaptation optical shift of 0 degrees.|Prism adaptation with optical shift of 0 degrees.
16206786|NCT01341548|Drug|Civamide nasal solution 0.01%|20ug/dose, BID for 7 days 0.1 ml to each nostril
16206787|NCT01341535|Radiation|Adaptive dose-painting-by-numbers|Adaptive dose escalation by dose-painting-by-numbers.
16206788|NCT01341535|Radiation|standard intensity-modulated radiotherapy (IMRT)|Standard radiotherapy for head and neck cancer.
16206789|NCT01341522|Procedure|MRI exam|MRI exam
16206790|NCT01341522|Procedure|control|waiting room
16206791|NCT01341509|Procedure|Flexor Hallucis Longus Tendon transfer|The flexor hallucis longus tendon was transferred during surgery for insertional achilles tendinopathy
16206792|NCT01341509|Procedure|Transfer of the Flexor Hallucis Longus Tendon|The Flexor Hallucis Longus Tendon was transferred during surgery for insertional achilles tendinopathy
16206793|NCT01341509|Procedure|No transfer of Flexor Hallucis Longus tendon|There was no transfer of the Flexor Hallucis Longus tendon in surgery for insertional achilles tendinopathy
16206794|NCT01341496|Biological|Epigenetically Modified Autologous Tumor|5x 10^7 autologous tumor cells emulsified in 0.5 mL ISCOMATRIX adjuvant will be administered IM every 4 weeks for 6 months
16206795|NCT01341496|Drug|Cyclophosphamide|50 mg PO BID for 7 days prior to the first dose of vaccine and then on days 8 through 14, and 22 through 28 of each 4 week treatment cycle
16206796|NCT01341496|Drug|Celecoxib|400 mg PO BID for 7 days prior to the first dose of vaccine and then on days 1 through 28 of each 4 week vaccine cycle.
16206797|NCT01341470|Drug|LY2495655|administered intravenously or subcutaneously
16206798|NCT01341470|Drug|Placebo|administered intravenously or subcutaneously
16206799|NCT01341457|Drug|LY2603618|Administered intravenously
16206800|NCT01341457|Drug|Gemcitabine|Administered intravenously
16206801|NCT01341444|Device|Prevena Incision Management System|It is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy (NPWT).
16206802|NCT01341444|Other|Standard of Care for Surgical Incisions|Sterile 4X4 Non-Penetrable barrier
16206803|NCT01341431|Drug|bee venom|12 monthly injections of 100 micrograms(in 1 milliliter of NaCl 0.9%) of bee venom s.c.
16206804|NCT01341418|Procedure|Suprapatellar approach|Suprapatellar surgical approach will be used for intramedullary nailing of tibial fractures. Arthroscopic photos will be obtained before and after nail insertion. Postoperative radiographs, outcome questionnaires and an MRI will be performed over ther course of one-year follow-up.
16206805|NCT01341418|Procedure|Infrapatellar approach|The Infrapatellar surgical approach will be used for intramedullary nailing of tibial fractures. No arthroscopic examination for this intervention. Postoperative radiographs, outcome questionnaires and an MRI will be performed over ther course of one-year follow-up.
16206806|NCT01341405|Drug|CG100649|capsule, 2 mg, once daily for 28 days
16206807|NCT01341405|Drug|Celecoxib|capsule, celecoxib 200 mg, once daily for 28 days
16206808|NCT01341405|Drug|CG100649|capsule, 4 mg, once daily for 28 days
16206809|NCT01341392|Drug|CKD-501|Subjects received CKD-501 0.5mg once daily for 10 days. Subjects received amlodipine 10mg once daily for 10 days. Subjects received CKD-501 0.5mg and amlodipine 10mg for 10 days.
16206810|NCT01341392|Drug|amlodiopine|Subjects received CKD-501 0.5mg once daily for 10 days. Subjects received amlodipine 10mg once daily for 10 days. Subjects received CKD-501 0.5mg and amlodipine 10mg for 10 days.
16206811|NCT01341392|Drug|CKD-501 amlodipine|Subjects received CKD-501 0.5mg once daily for 10 days. Subjects received amlodipine 10mg once daily for 10 days. Subjects received CKD-501 0.5mg and amlodipine 10mg for 10 days.
16206812|NCT01341379|Drug|N-carbamylglutamate|N-carbamylglutamate: 200 mg/kg/day for 3 days, divided into 4 daily oral doses
16206813|NCT01341366|Other|Fast-track perioperative program|Preoperative counseling, no preoperative fasting, short-acting anesthetics, continuous infiltration of wound with local anesthetic agent, non-opioid pain management, the use of chewing gum, and early postoperative feeding and mobilization
16206814|NCT01341366|Other|Traditional perioperative program|Preoperative fasting, standard anesthetic management with no intraoperative fluid restriction, opioid pain management, no chewing gum, feeding/mobilization according to attending surgeon
16206815|NCT01341353|Procedure|catheter ablation|circumferential pulmonary vein isolation complex fractionated atrial electrograms ablation circumferential pulmonary vein isolation combined left atrial roof ablation circumferential pulmonary vein isolation combined left atrial isthmus ablation circumferential pulmonary vein isolation combined left atrial roof and isthmus ablation circumferential pulmonary vein isolation combined complex fractionated atrial electrograms ablation
16206816|NCT01341353|Drug|Digaoxin,amiodarone,β receptor antagonist, Calcium Antagonists|
16206817|NCT01341340|Device|Everolimus Eluting BVS|Patients receiving the Everolimus Eluting Bioresorbable Vascular Scaffold System (BVS)
16206818|NCT01341301|Radiation|Total Body Irradiation|Undergo TBI
16206819|NCT01341301|Biological|Donor Lymphocyte Infusion (DLI)|Undergo DLI
16206820|NCT01341301|Drug|Cyclophosphamide|Given IV
16206821|NCT01341301|Drug|Tacrolimus|Given IV or PO
16206822|NCT01341301|Drug|Mycophenolate mofetil|Given IV or PO
16206823|NCT01341301|Procedure|Allogeneic hematopoietic stem cell transplantation|Undergo allogeneic HSCT
16206824|NCT01341301|Other|Laboratory biomarker analysis|Correlative studies
16206825|NCT01341288|Device|EUCLIDIAN Robot|EUCLIDIAN (Endo-Uro Computed Lattice for Intratumoral Delivery, Implantation, Ablation with Nanosensing) system for placement of radioactive seeds in the prostate
16206826|NCT01341275|Biological|hepatitis B vaccine|10 ug dose, one-time administration
16206827|NCT01341275|Biological|hepatitis B vaccine|20 ug dose, one-time administration
16206871|NCT01340911|Drug|SRT3025|SRT3025 will be supplied as hard gelatin capsules containing either 27.4 mg (25 mg SRT3025 free base equivalent) or 274 mg (250 mg SRT3025 free base equivalent) of SRT3025 HCl monohydrate drug substance.
16206925|NCT01340599|Procedure|therapeutic conventional surgery|Undergo radical prostatectomy
16206828|NCT01341262|Drug|Thalidomide|"INDUCTION THERAPY: 100 mg/d on days 1-14, 200 mg/d on days 15-120 (in case of delay of HD-CTX , Thalidomide will be continued until the day before Cyclophosphamide as priming therapy for PBSC collection)
~AFTER PBSC COLLECTION: 200 mg/d from day after last PBSC collection until the day before first course of MEL-200
~AFTER FIRST TRANSPLANTATION: 200 mg/d from recovery of hematopoiesis until the day before the second course of MEL-200"
16206829|NCT01341262|Drug|Dexamethasone|"INDUCTION THERAPY: 40 mg/d days 1-4, 9-12 and 17-20 (cycles 1 and 3, 30 days each); 40 mg/d days 1-4 (cycles 2 and 4, 30 days each)
~AFTER PBSC COLLECTION: 40 mg/d days 1-4 (starting the same day of resumption of Thalidomide)
~AFTER FIRST TRANSPLANTATION: 40 mg/d days 1-4 (starting the same day of resumption of Thalidomide) for 3 cycles (30 days each)"
16206830|NCT01341262|Drug|Zoledronic acid|"INDUCTION THERAPY: 4 mg i.v. once a cycle for 4 cycles (30 days each)
~AFTER PBSC COLLECTION: 4 mg i.v. once (the same day of resumption of Thalidomide)
~AFTER FIRST TRANSPLANTATION: 4 mg i.v. once a cycle (starting the same day of resumption of Thalidomide) for 3 cycles (30 days each)"
16206831|NCT01341262|Drug|Cyclophosphamide|Cyclophosphamide 7 g/sqm + G-CSF 5 mcg/Kg from the day +6 for stem cell mobilisation
16206832|NCT01341262|Drug|Melphalan|Melphalan 200 mg/sqm on day -1 for first and second ASCT
16206833|NCT01341249|Drug|Experimental DW224aa|DW224aa tablet, single dose
16206834|NCT01341249|Drug|Experimental DW224a|DW224a capsule, single dose
16206835|NCT01341236|Other|different nutrional regimen|compare bolus versus intermittent nutrition
16206836|NCT01341236|Other|comparison of different feeding regimens|compare intermittent versus bolus nutrition
16206837|NCT01341197|Other|Fecal immunochemical test, guaiac fecal occult-blood test, and Helicobacter pylori stool antigen test|
16206838|NCT01341184|Drug|Rifabutin|Rifabutin 300 mg orally on days 20-41
16206839|NCT01341184|Drug|Rifampin|Rifampin 600 mg orally on days 20-41
16206840|NCT01341184|Drug|TMC207|TMC207 400 mg orally on days 1 and 29
16206841|NCT01341158|Drug|human interferon-α|Neoadjuvant treatment: Multiferon is given as flat dosages (3 - 9 - 18 MIU) 5 days per week, subcutaneously for 4 weeks
16206842|NCT01341145|Behavioral|Aerobic Exercise|12-week moderate-intensity aerobic exercise program designed in accordance with the recommended guidelines established by the American College of Sports Medicine
16206843|NCT01341145|Behavioral|Relaxation|12-week progressive muscle relaxation program (active control)
16206844|NCT01341132|Procedure|MRI Scan of the Liver enhanced with Eovist|10mL of gadoxetate disodium administered intravenously while being scanned via the MRI. Images will be attained on a 5, 10 and 20 minute delay. Expected scan time is 45 minutes total
16206845|NCT01341106|Drug|Treatment with entecavir(Baraclude®)|Patient will be daily treated with 1 tablet of entecavir per oral
16206846|NCT01341093|Behavioral|educational program+telephone follow up|Patients will participate in the educational program with telephone follow-up, the education program will initiate in preoperative period and will continue for six months.
16206847|NCT01341093|Behavioral|Usual care|Patients will receive orientations about the surgery and the rehabilitation by health professionals, especially in the discharge. And will have return for evaluation scheduled by health professionals.
16206848|NCT01341080|Drug|Varenicline|Varenicline 1mg twice daily for eight weeks after a one week dose escalation period.
16206849|NCT01341080|Drug|Sugar pill|1mg twice daily for eight weeks after a one week dose escalation phase.
16206850|NCT01341054|Other|mouthwash with Chamomilla|The Chamomile recutita mouthwash was administered two times daily for 30 days. 10 mL of this solution was swished around in the mouth for approximately one minute and then expectorated.
16206851|NCT01341054|Other|Standard oral care protocol|The standard protocol at the unit, which comprises mouthwash with chlorhexidine 0,12% twice a day; oral hygiene teaching, recommended at least three times per day and always after meals. For brushing, brushes with extra-soft bristles and non-abrasive toothpaste are used. In case the toothbrush cannot be used due to gingival or oral mucosa bleeding, gauze is used to replace it.
16206852|NCT01341041|Biological|chlorine dioxide|one time wash with 50ppm CD solution
16206853|NCT01341041|Biological|saline|one time wash with 50-100 cc normal saline
16206854|NCT01341028|Procedure|Roux-en-Y gastric bypass (LRYGBP)|Twelve patients underwent laparoscopic Roux-en-Y gastric bypass
16206855|NCT01341028|Procedure|LRYGBP+gastric fundus resection|Twelve patients underwent laparoscopic Roux-en-Y gastric bypass and gastric fundus resection
16206856|NCT01341015|Other|Ultrasound|Single interventional group - patients agree to an ultrasound of potential ankle fracture, to be compared to standard of care xray.
16206857|NCT01341002|Procedure|Transfusion|Red Blood Cells (RBC) Transfusion if SCVO2 < 70% and guidelines
16206858|NCT01341002|Procedure|Transfusion|transfusion based on guidelines
16206859|NCT01340989|Procedure|alteration of the insufflation gas|addition of 4% oxygen
16206860|NCT01340989|Procedure|full conditioning|"addition of 4% oxygen + 10% nitrous oxide to the peritoneum
~humidification
~set temperature of 32°C"
16206861|NCT01340989|Procedure|standard pneumoperitoneum|no intervention besides the use of CO2
16206862|NCT01340976|Drug|LY2787106|Administered IV.
16206863|NCT01340976|Dietary Supplement|Iron Supplementation|Administered orally.
16206864|NCT01340950|Drug|zidovudine-lamivudine-nevirapine|96 weeks of zidovudine 300 mg orally twice daily, lamivudine 300 mg orally daily, nevirapine 200 mg orally daily for the first 14 days then 200 mg orally twice daily
16206865|NCT01340950|Drug|tenofovir-lamivudine-efavirenz|96 weeks of tenofovir disoproxil fumarate 300 mg orally daily, lamivudine 300 mg orally daily, efavirenz 600 mg orally daily
16206866|NCT01340937|Biological|V419|V419 (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Outer Membrane Protein Complex], and Hepatitis B [Recombinant] Vaccine) (from one of three lots) 0.5 mL intramuscular injection at 2, 4, and 6 months of age.
16206867|NCT01340937|Biological|PENTACEL™|PENTACEL™ 0.5 mL intramuscular injection at 15 months of age in the V419 groups and at 2, 4, 6, and 15 months of age in the control group
16206868|NCT01340937|Biological|Prevnar 13™|Prevnar 13™ 0.5 mL intramuscular injection at 2, 4, 6, and 15 months of age
16206869|NCT01340937|Biological|RotaTeq™|RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age
16206870|NCT01340937|Biological|Recombivax HB vaccine|Recombivax HB vaccine 0.5 mL intramuscular injection at 2 and 6 months of age
16206872|NCT01340911|Drug|Placebo|For placebo product, the SRT3025 drug substance will be replaced by Microcrystalline Cellulose (Avicel® PH 105) to match the SRT3025 investigational product.
16206873|NCT01340898|Biological|Meningococcal vaccine GSK 134612|Intramuscular injection
16206874|NCT01340898|Biological|SynflorixTM|Intramuscular injection
16206875|NCT01340898|Biological|Infanrix-IPV/HiberixTM|Intramuscular injection
16206876|NCT01340885|Drug|Strattera|10-30 mg b.i.d. for 6 weeks
16206877|NCT01340885|Drug|Exelon|1.5-4.5 mg b.i.d. for 6 weeks
16206878|NCT01340885|Other|Placebo|2-6 pills for 6 weeks
16206879|NCT01340872|Drug|ST10-021|30 mg capsules to be taken orally twice a day for 12 weeks
16206880|NCT01340872|Drug|Placebo Comparator|Matching sugar pill to be taken orally twice a day for 12 weeks
16206881|NCT01340859|Behavioral|Post Admission Cognitive Therapy (PACT)|Individual psychotherapy; 60-90 minutes sessions; 6 sessions over preferably 3 days of inpatient stay
16206882|NCT01340846|Drug|Warfarin|Warfarin dosed at 15mg on Day 1 and Day 22
16206883|NCT01340846|Drug|Ketoconazole|Ketoconazole dosed at 400mg daily on Days 19 through 22
16206884|NCT01340846|Drug|Gemfibrozil|Gemfibrozil dosed at 600mg twice daily on Days 19 through 22
16206885|NCT01340846|Drug|GSK2118436 150mg|GSK2118436 dosed at 150mg twice daily
16206886|NCT01340846|Drug|GSK2118436 75mg|GSK2118436 dosed at 75mg twice daily
16206887|NCT01340833|Drug|GSK2118436|Two capsules each containing 75 mg GSK2118436, followed by a single IV dose of 50 ug (no more than 7.4 kBq or 200 nCi) [14C]GSK2118436, starting 1.75 hours after the oral dose
16206888|NCT01340820|Drug|AERAS-422|rBCG
16206889|NCT01340820|Drug|BCG Tice|1-8 x 10^5 CFU
16206890|NCT01340807|Other|Specialized Functional Prosthetic Training|Each subject receives specialized functional prosthetic training
16206891|NCT01340794|Other|Laboratory Biomarker Analysis|Correlative studies
16206892|NCT01340794|Drug|Pazopanib Hydrochloride|Given PO
16206893|NCT01340781|Procedure|Polysomnogram|An attended polysomnogram will be conducted in the subjects room during an in patient hospital stay
16206894|NCT01340768|Drug|Sitagliptin|One 100 mg tablet taken orally once daily
16206895|NCT01340768|Drug|Sulfonylurea|Participant continued pre-study sulfonylurea therapy (dose as prescribed by the physician). Pre-study sulfonylurea therapy consisted of either glibenclamide, glimepiride or gliclazide.
16206896|NCT01340768|Drug|Metformin|Participants receiving metformin at enrollment, continued pre-study doses of metformin. If necessary, the physician could either discontinue or adjust the dose of metformin during Ramadan.
16206897|NCT01340755|Procedure|Transanal endoscopic surgery|Laparoscopy-assisted transanal endoscopic rectosigmoid resection
16206898|NCT01340742|Procedure|Remote Ischemic Pre-conditioning|Cuff placed on arm. Three 5- minute cycles of blood pressure cuff inflation: cuff is inflated to 200 mm Hg for 5 minutes followed by a 5-minute deflation (reperfusion.)
16206899|NCT01340742|Procedure|Control|Cuff placed on arm uninflated for 30 minutes.
16206900|NCT01340729|Drug|TPI 287|Starting dose of 125 mg/m2 IV via a central venous catheter (CVC) or a peripherally inserted central catheter (PICC) line over 60 minutes (+/- 10 minutes) on Days 1, 8, and 15 (+/- 2 days) of each 28 day (+/- 3 days) study cycle. The 4-week schedule composes one cycle.
16206901|NCT01340716|Other|Tai Chi Chuan exercise|patients in this group held three weekly classes of 60 minutes during 12 weeks of Tai Chi Chuan, Yang style. The exercises will be mild to moderate (HR 60 to 75% of HR Max). Slow movements combined with exercises and maintained using your own body weight.
16206902|NCT01340716|Other|stretching exercise|patients in this group held weekly classes of two stretching for 12 weeks.
16206903|NCT01340703|Procedure|vitrectomy without laser or gas tamponade|vitrectomy without laser or gas tamponade
16206904|NCT01340690|Dietary Supplement|ω-3 fatty acids suspension|2 bags of Esprico(R) suspension given orally once daily in the morning for 84 days
16206905|NCT01340690|Dietary Supplement|placebo suspension|suspension to mimic verum Esprico (R) suspension. 2 bags of Esprico(R) placebo suspension given orally once daily in the morning for 84 days
16206906|NCT01340677|Drug|Canagliflozin, 50 mg|Type=1, unit=mg, number=50, form=tablet, route=oral use.Tablet is taken once without food during 1 of 3 treatment periods.
16206907|NCT01340677|Drug|Canagliflozin, 300 mg|Type=1, unit=mg, number=300, form=tablet, route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.
16206908|NCT01340677|Drug|Canagliflozin, 100 mg|Type=1, unit=mg, number=100, form=tablet, route=oral use. Tablet is taken once without food during 1 of 3 treatment periods.
16206909|NCT01340664|Drug|Canagliflozin 50 mg|One canagliflozin 50-mg capsule taken orally twice daily with a meal for 18 weeks
16206910|NCT01340664|Drug|Placebo|1 placebo capsule taken orally twice daily with a meal for 18 weeks
16206911|NCT01340664|Drug|Canagliflozin 150 mg|1 canagliflozin 150-mg capsule taken orally twice daily with a meal for 18 weeks
16206912|NCT01340664|Drug|Metformin|The patient's stable daily dose of Metformin background therapy should be continued throughout the study.
16206913|NCT01340651|Drug|Ruxolitinib|Ruxolitinib was supplied as SR and IR formulated tablets.
16206914|NCT01340638|Device|cookgas mask|This group will be assigned to use cookgas mask
16206915|NCT01340638|Device|LMA mask|LMA mask
16206916|NCT01340625|Drug|Norethindrone/Ethinyl Estradiol|0.4 mg/35 mcg Chewable Tablets
16206917|NCT01340625|Drug|Ovcon® 35 Fe|0.4 mg/35 mcg Chewable Tablets
16206918|NCT01340612|Device|endovascular coiling with any type of currently approved coil (first or second generation)|Standard procedure for endovascular coiling.Coils may be bare Platinum coils or any so-called second generation coils such as but not restricted to Hydrocoil or Cerecyte
16206919|NCT01340612|Device|endovascular stenting with or without coiling. The stent may be any of the currently approved stents for intracranial aneurysms.|Standard procedure for stenting. Addition of coils to the stent is left to the judgment of the treating physician
16206920|NCT01340599|Dietary Supplement|defined green tea catechin extract|Given PO
16206921|NCT01340599|Other|placebo|Given PO
16206922|NCT01340599|Other|immunohistochemistry staining method|Correlative studies
16206923|NCT01340599|Other|immunoenzyme technique|Correlative studies
16206924|NCT01340599|Other|questionnaire administration|Ancillary studies
16206926|NCT01340599|Other|high performance liquid chromatography|Correlative studies
16206927|NCT01340599|Other|mass spectrometry|Correlative studies
16206928|NCT01340586|Drug|Apixaban|Tablets, Oral, 5 mg, Once, 4 days
16206929|NCT01340586|Drug|Apixaban|Tablets, Oral, 5 mg, Twice, 15 days
16206930|NCT01340573|Drug|PegIntron Pen|Peginterferon alfa-2b, 1.5 microgram/kg each week, administered subcutaneously.
16206931|NCT01340573|Drug|Ribavirin|Dose is based on body weight. Each tablet of ribavirin is 200mg, and given by oral administration. Participants with body weight of <65 kg were administered 800 mg of ribavirin daily, body weight of 65 kg-85 kg received 1000 mg daily, and participants with a body weight of >85 kg received 1200 mg of ribavirin daily.
16206932|NCT01340560|Procedure|Endometrial biopsy|Endometrial biopsy was performed with biopsy catheter
16206933|NCT01340547|Drug|palifosfamide-tris|palifosfamide-tris IV infusion of 150 mg/m2 on Days 1, 2 and 3 every three weeks (21 day cycle)
16206934|NCT01340547|Drug|Normal Saline|0.9% Normal Saline 250 ml IV infusion on Cycle 1 Day -1
16206935|NCT01340534|Device|Supplemental oxygen 80% FIO2|Use of oxygen 80% FIO2 during surgery and 2 hours after the procedure. For this purpose an oxygen mask with reservoir will be used (to guarantee the supply of 80% oxygen during and after surgery)
16206936|NCT01340534|Procedure|Use of air (no oxygen during surgery)|No use of oxygen during surgery or in the 2 hours after the procedure.
16206937|NCT01340521|Drug|Clomiphene Citrate|0, 25, 50 or 100 milligrams daily. Will be taken orally days five through nine of the menstrual cycle.
16206938|NCT01340508|Radiation|Intensity Modulated Radiotherapy|Intensity modulated radiotherapy to a dose of 55Gy in 25 fractions
16206939|NCT01340495|Radiation|Proton Radiation|45-50.4 Gy(RBE) to the chest wall and 45-50.5 Gy(RBE) once daily, 5 days per week, for approximately 5 1/2 weeks
16206940|NCT01340482|Drug|KRN23|Subjects will receive escalating doses of KRN23 administered by SC injections every 28-days (up to 4 doses) based on a dosing algorithm and discretion of the investigator and sponsor.
16206941|NCT01340469|Biological|probiotics|Daily enteral probiotic supplementation (live Lactobacillus acidophilus and Bifidobacterium infantis) at a dose of 2.5 x 108 CFU of each strain once a day.The supplementation was started on the first day of enteral feeding and continued for at least 28 days or until discharge. The study drug was in liquid form and mixed with breast milk or formula before given to the infants. The preparation was made on a daily basis by one person who was not involved in the care of the infants.
16206942|NCT01340456|Drug|Rifampicin treatment|induction of CYP3A4 with one of three rifampicin doses (10, 20, 100 mg QD)
16206943|NCT01340430|Drug|Trastuzumab|neoadjuvant FEC (fluorouracil, epirubicin, cyclophosphamide) followed by weekly paclitaxel and concomitant trastuzumab
16206944|NCT01340417|Other|Measurements of melatonin levels in urine, blood, milk.|Measurements of melatonin levels in urine, blood, milk.
16206945|NCT01340404|Procedure|Stem cell transplantation|Stem cell transplantation
16206946|NCT01340404|Procedure|Transfusion program|Transfusion program
16206947|NCT01340391|Device|Omnicast|dorsal splint 2-5 weeks
16206948|NCT01340365|Behavioral|Tai Chi Exercise|Practicing Tai Chi exercise 4 times a week for 6 months - twice in a classroom and twice independently
16206949|NCT01340365|Behavioral|Tai Chi|Usual care, individuals attend testing sessions for 6 months with testing at times 0, 3, and 6 months. Individuals in Usual Care receive 3 months of Tai Chi at the study end.
16206950|NCT01340339|Device|Phototherapy|Fluorescent reverse phototherapy (7 white lights 5cm below the base of acrylic cot), with spectral irradiance of 8-12microwatts/cm2/nm; daily; until bilirubin reaches level that indicates suspension of therapy
16206951|NCT01340339|Device|Phototherapy|super LED reverse phototherapy (17 bulbs arranged in 42 x 31 cm in blue base acrylic cot), with spectral irradiance of 8-12microwatts/cm2/nm; daily; until bilirubin reaches level that indicates suspension of therapy
16206952|NCT01340326|Drug|high dose of valsartan|comparison of different dosages of drug
16206953|NCT01340326|Drug|usual dose of valsartan|comparison of different dosages of drug
16206954|NCT01340300|Behavioral|Exercise training|Two supervised exercise sessions per week
16206955|NCT01340300|Drug|Metformin|Oral metformin QD for two weeks, then BID
16206956|NCT01340300|Other|Educational information|educational information
16206957|NCT01340287|Dietary Supplement|1- plain low-fat dairy fermented product (drinkable) enriched with plant sterols-esters (1,6g /day equivalent as free sterols).|1 = Intervention 1 (1 test product/day)
16206958|NCT01340287|Dietary Supplement|2- plain low-fat dairy fermented product (drinkable) without plant sterols-esters|2 = Intervention 2 (1 control product/day)
16206959|NCT01340274|Behavioral|CRAFT treatment|Clients will receive 12 sessions of CRAFT delivered over a 12 week period. There will be 1 session per week.
16206960|NCT01340274|Behavioral|Treatment as Usual|Clients will receive Treatment as Usual delivered over 12 session. There will be 1 session per week.
16206961|NCT01340261|Behavioral|Questionnaires|Questionnaires are completed at admission, discharge, 1-month, 6 month, and yearly follow-up.
16206962|NCT01340248|Drug|Dilatrend 64mg capsule|"Dilatrend 64mg capsule during fasting + Dilatrend 64mg capsule after high fat diet
~Dilatrend 64mg capsule after high fat diet + Dilatrend 64mg capsule during fasting"
16206963|NCT01340235|Drug|Oral erythromycin|Severe Dowling Meara EBS patients from 6 months to 8 years old
16206964|NCT01340222|Biological|biological samples|4 blood sampling will be made at J0, J2, J4, J6 befor delivery and 1 blood sampling 3 days after delivery
16206965|NCT01340209|Drug|Tiotropium Respimat|Tiotropium high dose once daily delivered with Respimat inhaler
16206966|NCT01340209|Drug|Placebo Respimat|Tiotropium placebo once daily delivered with Respimat inhaler
16206967|NCT01340209|Drug|Tiotropium Respimat|Tiotropium low dose once daily delivered with Respimat inhaler
16206968|NCT01340196|Drug|tenofovir/BI 201335|tenofovir medium dose once daily (qd) for first 15 days; BI 201335 medium dose twice daily (bid) on days 8 through 22 with last dose on morning of day 22
16206969|NCT01340183|Drug|AZD5099|IV Dose
16206970|NCT01340183|Drug|Placebo|IV Dose
16206971|NCT01340170|Device|OsseoSpeed TX|OsseoSpeed TX dental implants, 6-17 mm
16206972|NCT01340157|Drug|Fexinidazole|Single oral dose of 1200mg fexinidazole consisting of 2 tablets dosed at 600mg per tablet.
16206973|NCT01340131|Drug|CKD-828|Drug: Telmisartan 40mg + S-Amlodipine 5mg(FDC) Tablet, Oral, Once Daily
16206974|NCT01340131|Drug|Combination Therapy|"Drug: Telmisartan 40mg Tablet, Oral, Once Daily
~Drug: S-amlodipine 5mg Tablet, Oral, Once Daily"
16206975|NCT01340118|Drug|Budesonide|once daily inhalation with 400 µg budesonide (dry powder)during 6 weeks
16206976|NCT01340105|Procedure|Microwave ablation|Use of microwave energy to ablate hepatocellular carcinoma. It can be employed by percutaneous, open surgery or laparoscopic means.
16206977|NCT01340105|Procedure|Radiofrequency ablation|Use of radiofrequency energy to ablate hepatocellular carcinoma. It can be employed by percutaneous, open surgery or laparoscopic means.
16206978|NCT01340092|Other|Family Navigator|"Families in the intervention group will receive approximately six sessions with a Family Navigator. The Family Navigator will:
~Help family identify key issues they need to address to get their child autism-specific services
~Help family address barriers to obtaining these services and strategize approaches to overcome them."
16206979|NCT01340079|Behavioral|virtual world|health education using virtual world Second Life
16206980|NCT01340079|Behavioral|face to face|health education delivered in face to face groups
16206981|NCT01340066|Drug|UISH001|sublingual dosing, 1 drop 3 times a day
16206982|NCT01340066|Drug|matching placebo|sublingual dosing,1 drop 3 times a day
16206983|NCT01340053|Drug|RDX5791|Capsule, QD
16206984|NCT01340040|Drug|MEDI-573|MEDI-573 will be administrated once 7 days in Cohort 1 and 2, and once every 21 days in Cohort 3 as a IV infusion as part of a 21-day treatment cycle.
16206985|NCT01340027|Drug|Mirabegron|oral
16206986|NCT01340027|Drug|Solifenacin succinate|oral
16206987|NCT01340027|Drug|Placebo|oral
16206988|NCT01340014|Drug|Brinzolamide 1.0% + Timolol 0.5% ophthalmic suspension|
16206989|NCT01340014|Drug|Dorzolamide 2.0% + Timolol 0.5% ophthalmic solution|
16206990|NCT01340001|Procedure|Electrical stimulation of the nucleus basalis of Meynert|Differents parameters will be assessed.
16206991|NCT01339988|Drug|Busulfan/Cyclophosphamide|"Conditioning regimen:
~Cyclophosphamide 50mg/kg/day for 4 days + Busulfan 0.8-1.0mg/kg/day for 4 days."
16206992|NCT01339975|Biological|Biological sample|"2 blood samples of 10mL + one urine sample
~on pre-operative d-1/d, post-operative d1 and d5(+/-2),
~one month post-operative,
~at the end of the study in the absence of disease progression or at the date of recurrence or progression if the case arises."
16206993|NCT01339975|Biological|Biological sample|"2 blood samples of 10mL + one urine sample
~before starting the therapy
~at first therapeutic evaluation (2 or 3 months depending on the treatment chosen)
~at the end of the study or at the date of disease progression."
16206994|NCT01339962|Other|Non-interventional|Non-interventional (retrospective chart reviews)
16206995|NCT01339949|Device|IRay|low voltage external beam radiosurgery
16206996|NCT01339949|Device|IRay|low voltage external beam radiosurgery
16206997|NCT01339936|Device|Carboxymethylcellulose sodium, glycerin and polysorbate 80|1 drop in each eye three times a day for a period of 30 (± 4) days
16206998|NCT01339923|Biological|rMenB + OMV NZ vaccine|3 doses (2.5, 3.5, 5 months if age) plus booster (11 months of age)
16206999|NCT01339923|Biological|rMenB + OMV NZ vaccine|2 doses (3.5, 5 months of age) plus booster (11 months of age)
16207000|NCT01339923|Biological|rMenB + OMV NZ vaccine|2 doses (6, 8 months of age) plus booster (11 months of age)
16207001|NCT01339923|Biological|rMenB + OMV NZ vaccine|2 doses 2 months apart
16207002|NCT01339923|Biological|Meningococcal C oligosaccharide conjugated vaccine|Schedule 3, 5, 7, 12, Meningococcal C oligosaccharide conjugated vaccine
16207003|NCT01339923|Biological|Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.|Schedule 3, 5, 7, 12 Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
16207004|NCT01339923|Biological|rMenB + OMV NZ vaccine|Schedule 3, 5, 12 rMenB + OMV vaccine
16207005|NCT01339923|Biological|rMenB + OMV NZ vaccine|Schedule 13,15 rMenB + OMV vaccine
16207006|NCT01339910|Drug|Fludarabine and Busulfan|"(Flu/Bu)
~Fludarabine: 30 mg/m^2/day on Days -6 to -2 (total dose of 150 mg/m^2)
~Busulfan: 4 mg/kg/day PO or 3.2 mg/kg/day (total dose of 8 mg/kg or 6.4 mg/kg, respectively) on Days -5 to -4"
16207007|NCT01339910|Drug|Fludarabine and Melphalan|"(Flu/Mel)
~Fludarabine: 30 mg/m^2/day on Days -5 to -2 (total dose of 120 mg/m^2)
~Melphalan: 140 mg/m^2 on Day -2"
16207008|NCT01339910|Drug|Busulfan and Fludarabine|"(Bu/Flu)
~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or mg/m^2/day with Bu Css 900±100 ng/mL (total dose of 16 mg/kg, 12.8 mg/kg or 520 mg/m^2, respectively) on Days -5 to -2
~Fludarabine: 30 mg/m^2/day on Days -5 to -2: Flu (total dose of 120 mg/m^2)"
16207009|NCT01339910|Drug|Busulfan and Cyclophosphamide|"(Bu/Cy)
~Busulfan: 4 mg/kg/day PO, 3.2 mg/kg/day IV or 130 mg/m^2/day with Bu Css 900 ± 100 ng/mL (total dose of 16 mg/kg or 12.8 mg/kg or 520 mg/m^2, respectively) on Days -7 to -4
~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)"
16207010|NCT01339910|Drug|Cyclophosphamide and Total Body Irradiation|"(Cy/TBI)
~TBI: 1200-1420 cGy on Days -7 to -4
~Cyclophosphamide: 60 mg/kg/day on Days -3 to -2 (total dose of 120 mg/kg)"
16207011|NCT01339897|Drug|5 mg/N6022|Intravenous formulation, given at doses of 5 mg once each day over 7 days.
16207012|NCT01339897|Drug|Placebo|Same administration procedures as active
16207013|NCT01339897|Drug|10mg/N6022|Intravenous formulation given at doses of 10 mg once each day over 7 days.
16207014|NCT01339897|Drug|20mg/N6022|Intravenous formulation given at doses of 20 mg once each day over 7 days.
16207015|NCT01339884|Drug|Resveratrol|Resveratrol 1g daily (500mg twice daily) for 12 weeks Resveratrol 5 daily (2.5g twice daily) for 12 weeks
16207016|NCT01339871|Drug|Pazopanib|Starting dose 400 mg orally daily of 28 day cycle.
16207017|NCT01339871|Drug|Vorinostat|Starting dose 100 mg orally daily of 28 day cycle.
16207018|NCT01339858|Drug|N-Acetyl Cysteine|NAC and matched placebo will be supplied in unmarked capsules. Each NAC capsule will contain 480 mg of NAC. Dosing will begin at 480 mg/d and titrated up by 480 mg/d each week until a maximum dose of 2880 mg/d (BID) is reached. This approximate dose was effective and well tolerated in a recent study of treatment refractory obsessive-compulsive disorder by Krystal and colleagues at Yale (16). In addition, a double-blind placebo controlled trial recently completed at IUSM Riley Hospital in children (age 4 to 12 years) with autism spectrum disorders used doses ranging from 900 mg/day to 4200 mg/day and reported no serious adverse events and found the agent well tolerated (15). Dose adjustments downward to 1920 mg/d will be permitted if tolerability issues are encountered at the maximum dose
16207019|NCT01339858|Other|sugar pill|matched placebo will be supplied in unmarked capsules. Dosing regimen will be the same as in the N-Acetyl Cysteine arm.
16207020|NCT01339845|Biological|ShanChol|Each dose of the vaccine contains whole cell Killed inactivated V.cholerae O1 and O139 strains.Vaccine is packaged as liquid formulations in 1.5-ml doses. The vaccine is given two doses separated by a two week interval and administered orally.
16207021|NCT01339845|Behavioral|Vaccine and behaviour|Together with vaccination the community health worker will offer a hand washing station and water treatment facilities that include both hardware and a software component. The idea of the handwashing station is to bring together with soap and water that people need for handwashing, especially for handwashing after defecation. The hardware for water treatment is a chlorine dispenser that is a reservoir which holds sodium hypochlorite and dispenses a measured dose of the dilute sodium hypochlorite into a 15 liter water tank. Community residents can collect water directly from the 15 L water tanks into their own personal water storage vessels. The community health worker will negotiate with compound residents for the development of a water treatment system.
16207022|NCT01339819|Drug|Dabigatran|Patients assigned to this group will receive Dabigatran
16207023|NCT01339819|Drug|Phenprocoumon|Patients assigned to this group will receive Phenprocoumon
16207024|NCT01339806|Behavioral|Cognitive Rehab|APT-III, Other standard individual and group interventions.
16207025|NCT01339806|Behavioral|Brainworks|POSIT
16207026|NCT01339806|Behavioral|Informational Handout/Provider Visits|Provider based visits every three weeks and informational handout given to patient in regulation with current standard of care procedures.
16207027|NCT01339780|Radiation|BS, SPECT/CT, PET/CT, MRI|Planar bone scintigraphy (BS), single photon emission computed tomography combined with low-dose computed tomography (SPECT/CT), 18F-fluoride positron emission tomography computed tomography (PET/CT) and magnetic resonance imaging (MRI) will be performed to all patients.
16207028|NCT01339754|Drug|trabectedin|1.3 mg/mq as a 3 hour continuous infusion every three weeks
16207029|NCT01339754|Drug|trabectedin|1.3 mg/mq as a 3 hour continuous infusion every three weeks until progression
16207030|NCT01339741|Dietary Supplement|Vitamin D3|Vitamin D3, oral supplement, 12 weeks
16207031|NCT01339741|Drug|Placebo|Placebo, oral route, 12 weeks
16207032|NCT01339728|Procedure|far-infrared ray|The duration of far-infrared ray is 20 minutes.
16207033|NCT01339715|Procedure|acupuncture and far-infrared ray|During experimental phase,inserting the needle of acupuncture into CV12 acupoint or using far-infrared ray to illuminate on CV12 20 minutes.
16207034|NCT01339702|Other|The National Prehospital TBI Management Guidelines|"In the post-implementation (after) cohort, implementation of the entire bundle of the TBI treatment guidelines with special emphasis on prevention and treatment of hypotension (IV crystalloids), prevention and treatment of hypoxia (pre-oxygenation with high-flow O2 via non-rebreather mask, bag-valve-mask, extraglottic airways/intubation when basic maneuvers have failed), and prevention of hyperventilation (in intubated patients) and prevention/treatment of hypoventilation (in all patients)."
16207035|NCT01339689|Drug|Ganaxolone|200-600 mg bid, capsules, up to 12 weeks
16207036|NCT01339689|Drug|Placebo|capsules, bid, up to 12 weeks
16207037|NCT01339676|Drug|Colecalciferol|Once weekly treatment with peroral colecalciferol capsules (Dekristol®, Swiss-Caps, Switzerland) containing 20 mg of colecalciferol corresponding to 20000 IU or 0.5 mg of vitamin D
16207038|NCT01339676|Drug|Placebo capsules|Identically appearing once weekly peroral placebo capsules
16207039|NCT01339663|Drug|cyclophosphamide|Given IV
16207040|NCT01339663|Biological|aldesleukin|Given SC
16207041|NCT01339663|Biological|autologous tumor cell vaccine|Receive T-APC via IV
16207042|NCT01339663|Other|laboratory biomarker analysis|Correlative studies
16207043|NCT01339663|Other|immunologic technique|Correlative studies
16207044|NCT01339663|Other|immunohistochemistry staining method|Correlative studies
16207045|NCT01339663|Genetic|polymerase chain reaction|Correlative studies
16207046|NCT01339663|Biological|therapeutic autologous lymphocytes|Receive adoptively transferred CD8+ antigen-specific T cell clones via IV
16207047|NCT01339650|Drug|ABT-767|ABT-767 once or twice daily for a 28 day cycle
16207048|NCT01339624|Drug|FENTANYL|FENTANYL CITRATE, NASAL, 3 GAMMA/KG
16207049|NCT01339624|Drug|Ketorolac Tromethamine AND morphine|morphine 5 MG diluted in saline solution 100 ml followed by 2-ml ampoule of ketorolac 30 MG in saline solution 100 ml was infused:
16207050|NCT01339611|Behavioral|Educational program|Individual orientation (slides) during hospitalization period and telephone follow-up after discharge
16207051|NCT01339598|Device|Transcranial direct current stimulation (Eldith DC Stimulator)|Eldith DC Stimulator (NeuroConn GmbH, Germany)
16207052|NCT01339585|Device|Transcranial direct current stimulation (tDCS)|Eldith Direct Current Stimulator (NeuroConn GmbH, Germany)
16207053|NCT01339572|Drug|Plerixafor|"240 mcg/kg/day based on ideal body weight will be given for the following conditions:
~Pre-apheresis peripheral blood CD34+ count <20 cells/μL on day 5.
~Estimated CD34+ cell collection is < 25% of target cell dose after 1 day of apheresis.
~Estimated CD34+ cell collection is < 50% of target cell dose after 2 days of apheresis."
16207054|NCT01339572|Drug|Filgrastim|"All patients will receive filgrastim starting 4 days prior to apheresis (D1-4 mobilization). The dose and schedule of filgrastim will based upon the risk category of the patient:
~Standard risk: 5 μg/kg SQ BID.
~High risk: 10 μg/kg SQ BID."
16207055|NCT01339559|Drug|Brivaracetam|"Tablet, Flexible dosing up to 200 mg/day, twice daily.
~The study will continue until either regulatory approval of brivaracetam has been granted by any Health Authority in an indication of adjunctive treatment of partial onset seizures or until the Sponsor decides to close the study, or until the investigational product development is stopped by the Sponsor."
16207056|NCT01339546|Other|no intervention|
16207057|NCT01339533|Device|Mechanical Ventilation|Patients who experience problems breathing and require assistance in breathing are placed on a machine that delivers air to the lungs through a tube through the vocal cords. This study is testing 3 protocols for that machine.
16207058|NCT01339520|Behavioral|Scorecard|Points were assigned for blood pressure, HbA1c level, LDL-cholesterol level, aspirin use and exercise level.
16207059|NCT01339520|Behavioral|Control|Standard of care for diabetes subjects
16207156|NCT01338909|Drug|Clopidogrel|Clopidogrel 150mg/d starting from Day 1
16207060|NCT01339494|Dietary Supplement|Arginine and citrulline supplementations|Arginine or citrulline will be given orally at dose of 10 grams per meter square body surface area per day divided every 4 hours.
16207061|NCT01339481|Drug|abatacept|Intravenous Infusion
16207062|NCT01339468|Drug|Advagraf|oral
16207063|NCT01339468|Drug|Prograf|oral
16207064|NCT01339468|Drug|Prograf|intravenous
16207065|NCT01339455|Procedure|AHSCT|"AHSCT Procedure:
~Mobilization and Harvesting:
~Cyclophosphamide
~Rituximab
~GSCF
~Dexamethasone
~Apheresis
~Conditioning and Infusion (3-4 weeks after Mobilization and Harvesting):
~Cyclophosphamide
~MESNA
~Rabbit ATG
~Rituximab
~Methylprednisolone
~Stem Cell infusion
~GSCF"
16207066|NCT01339442|Drug|BKM120|
16207067|NCT01339442|Drug|Fulvestrant|
16207068|NCT01339442|Procedure|biopsy|Correlative studies
16207069|NCT01339429|Device|simplified negative pressure wound therapy device (Wound Pump device)|A non-powered negative pressure device utilizing a bellows attached to a specialized dressing via drainage tube to promote healing of open wounds.
16207070|NCT01339403|Other|non-interventional trial|No study specific intervention, non-interventional trial
16207071|NCT01339403|Other|non-interventional trial|No study specific intervention, non-interventional trial
16207072|NCT01339390|Behavioral|MOVE OUT|The MOVE OUT intervention builds on the high quality information provided by the nationally-developed MOVE program by adding 1) peer support; 2) convenient local access to educational sessions, which allows the material to be delivered in smaller, more easily retained aliquots; 3) convenient local exercise opportunities; and 4) open-ended availability of both education and exercise support.
16207073|NCT01339390|Behavioral|MOVE!|"As part of routine care at the ZVAMC, all patients who are eligible for the present study are identified by a clinical reminder. This reminder prompts the PCP to determine if the person would benefit from a weight loss program, and to refer them to MOVE if they and the patient agree that it would be beneficial. The MOVE program in Milwaukee can be tailored by the patient and PCP, but includes dietitian assessment, education, weekly weigh-ins, follow-up classes, and exercise programs."
16207074|NCT01339377|Device|AO-1000|Mixture of 2 weight% ozone in 98 weight% oxygen injected into the nucleus pulposus of a contained herniated disc.
16207075|NCT01339364|Other|Didactic Lecture|2 sessions of didactic lecture with PowerPoint presentations each delivered by a special lecturer. whole education period lasts 3 hours.
16207076|NCT01339364|Other|Interactive Lecture|2 sessions of brief interactive lectures followed by case discussion sections.
16207077|NCT01339364|Other|Lecture plus Small Group Education|A 1.5 hours session of didactic lecture followed by a session of small group education with 3 simulated patients.
16207078|NCT01339351|Behavioral|Therapeutic Group by Teleconference|10 sessions
16207079|NCT01339338|Procedure|warming the contrast media|warm the contrast media with 37℃ water-bathing
16207080|NCT01339325|Procedure|Cholecystectomy|"Standard laparoscopic cholecystectomy The first cannula is inserted with an open laparoscopy technique. LCs are performed with either HF or US energized dissection, standard or fundus-first gallbladder dissection, closure of the artery by ligature/clip or US, closure of cystic duct by ligature/clip.
~Laparo-endoscopic single site cholecystectomy
~The TriPort device is inserted at the navel site through a 15 to 25 mm incision with an open laparoscopy technique. Two working instruments are inserted (one grasper and one energised device) through the TriPort. A further 1.8 or 3 mm instrument inserted through the larger gel valve, parallel to a 5 mm dissecting instrument, is used in some cases to enhance exposure. Gallbladder dissection is accomplished either after preparation of the cystic duct and artery or with a fundus-first technique, by means of HF electrosurgery or US shears.The cystic artery is divided between clips or by US scissors. The duct is divided between clips."
16207081|NCT01339312|Biological|Purified inactivated rabies vaccine, serum free|0.5 mL, Intramuscular
16207082|NCT01339312|Biological|Purified inactivated rabies vaccine, serum free|0.5 mL, Intramuscular
16207083|NCT01339312|Biological|Purified Vero Rabies Vaccine|0.5 mL, Intramuscular
16207084|NCT01339312|Biological|Purified Vero Rabies Vaccine|0.5 mL, Intramuscular
16207085|NCT01339299|Drug|recombinant luteinizing hormone (r-LH)|administration of r-LH 150 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)
16207086|NCT01339299|Drug|recombinant human chorionic gonadotropin (r-hCG)|administration of r-hCG 25 IU/day subcutaneously , from S1 to r-hCG administration day (treatment day 10 to 14)
16207087|NCT01339286|Drug|atomoxetine|Atomoxetine will be titrated to optimal dose, beginning with 0.5mg/kg.d, then increasing to 1.2mg/kg.d in two weeks and maintaining for 4 weeks. If the optimal dose does not achieved, the dose can be increased further to 1.4mg/kg.d and maintained for 4 weeks.
16207088|NCT01339273|Procedure|Ultrasound guided Transversus Abdominis Plane (TAP) bock|Ultrasound guided TAP bock with Bupivacaine 0.25% 20ml per side or to a maximum 1mg/kg per side and the skin puncture will be covered with a small plaster
16207089|NCT01339273|Procedure|Local anaesthetic infiltration of laparoscopic port sites|Laparoscopic port sites and specimen extraction site will be infiltrated with a total of 40 mls 0.25% bupivacaine subcutaneously at the end of the procedure in the control group and plasters will be stuck on either side approximately where a skin puncture for tap block would be made.
16207090|NCT01339260|Drug|Netupitant and Palonosetron|
16207091|NCT01339260|Drug|Palonosetron|
16207092|NCT01339260|Drug|Dexamethasone|
16207093|NCT01339247|Drug|Paxil CR 25 mg manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico|Paroxetine Hydrochloride 25 miligrams(mg) tablet with controlled release (Paxil CR), once a day, manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation)
16207094|NCT01339247|Drug|Paxil CR 25 mg manufactured by GlaxoSmithKline Inc. - Mississauga - Canada|Paroxetine Hydrochloride 25 mg tablet with controlled release (Paxil CR), once a day, manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation)
16207120|NCT01339039|Drug|Plerixafor|Given subcutaneously once a day for 3 weeks followed by 1 week off (standard 3x3 design); MTD determined in Part 1 will be used as dose in Part 2.
16207121|NCT01339039|Drug|Plerixafor|Given subcutaneously once daily; MTD determined in Part 1 will be used as dose in Part 3.
16207122|NCT01339039|Drug|Bevacizumab|Given intravenously on days 1 and 15 (10 mg/kg) of each 28-day cycle
16207123|NCT01339039|Drug|Plerixafor|Daily administration for 5-9 days prior to surgery
16207095|NCT01339234|Other|Body-weight supported treadmill training|Patients will undergo training using the Woodway Loco-system which consists of a treadmill with an overhead pulley system connected to a support harness. BWSTT allows patients with limited mobility to safely walk upright on a treadmill with a portion of their body weight counter balanced. Three trainers will be required to assist with the BWSTT program. Two trainers will be positioned at the lower limbs to manually guide the participant through a proper gait motion and provided lower limb control. A third trainer will stand behind the participant to provide trunk support and assist with weight shifting.
16207096|NCT01339221|Procedure|Stool samples|Stool samples collected and checked for the presence of rotavirus
16207097|NCT01339208|Other|Telemedicine diabetes intervention|3 month duration telemedicine consultation and diabetes education
16207098|NCT01339195|Behavioral|French adaptation of NINDS-Canadian Stroke Network battery|"clinical: post-stroke neurological follow-up assessment
~neuropsychological: comprising the NINDS-Canadian Stroke Network neuropsychological battery
~MRI"
16207099|NCT01339182|Drug|Pegylated-Somatropin|Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-Somatropin, 10mcg/kg.
16207100|NCT01339182|Drug|YPEG-Somatropin|Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 30mcg/kg.
16207101|NCT01339182|Drug|YPEG-Somatropin|Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 60mcg/kg.
16207102|NCT01339182|Drug|YPEG-Somatropin|Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 120mcg/kg.
16207103|NCT01339182|Drug|YPEG-Somatropin|Daily s.c, randomized with Saizen, 0.1IU/kg or 0.15IU/kg for the first week, followed by one week wash-out, and then s.c, single dose of pegylated-somatropin, 200mcg/kg.
16207104|NCT01339169|Drug|YF476|50 mg once daily for 12 weeks, with the option to increase to 75 mg or 100 mg once daily after 6 weeks, or decrease to 25 mg once daily, depending on response. After that, patients that have benefited from treatment may take 50 mg YF476 once daily for an additional up to 52 weeks.
16207105|NCT01339156|Drug|P3914|"Part A:
~The subjects will be fasted overnight for at least 10 hrs.The drug will be administered orally to each subject in sitting posture.
~Part B:
~Dosing will start on Day 1. Each subject will receive the investigational product under fasting conditions for 14 days (Days 1 to 14).
~The investigational product will be administered orally to each subject with 240 mL of water.
~Part C:
~Dosing will take place on Day 1 of each study period. Each subject will receive a single oral dose.
~For administration of P3914 tablets subjects will be required to fast for 10 hrs prior to dosing.
~Part D:
~Patients will be fasted for at least 4-6 hrs. The investigational product will be administered orally to each subject in sitting posture on day 1 within 6 hrs of first administration of anesthesia (day of dental surgery)."
16207106|NCT01339156|Drug|Placebo|"Part A:
~The subjects will be fasted overnight for at least 10 hrs. The investigational product (allocated as per the randomisation schedule) will be administered orally to each subject in sitting posture.
~Part B:
~Dosing will start on Day 1. It is planned that each subject will receive the investigational product under fasting conditions for 14 days (Days 1 to 14).
~The investigational product (allocated as per the randomisation schedule) will be administered orally to each subject with 240 mL of water.
~Part D:
~Patients will be fasted for at least 4-6 hrs. The investigational product (allocated as per the randomisation schedule) will be administered orally to each subject in sitting posture on day 1 within 6 hrs of first administration of anesthesia (day of dental surgery)."
16207107|NCT01339143|Drug|Galvus (vildagliptin)|50mg BID, PO, for 16 weeks
16207108|NCT01339143|Drug|pioglitazone|15mg, QD, PO, 16 weeks
16207109|NCT01339130|Behavioral|Computerized tests and Electrophysiological measurements|"Computerized tests: used to evaluate the empathy The participant observes a computer screen on which appears different types of images or words that can evoke an emotion. The participant responds by pressing the screen with his finger. This is a choice between several answers and respond as quickly as possible.
~Electrophysiological measurements: provide a measure of autonomic response to emotional stimuli: galvanic response (GSR) and electromyographic activity (EMG) of facial muscles (corrugator supercilii and zygomatic major).
~Neuropsychological assessment includes an assessment of intellectual efficiency, perceptual and visual-constructive abilities, memory, executive and an assessment of behavior and mood from questionnaires."
16207110|NCT01339117|Other|Low fermentable substrate diet|Diet low in fermentable oligosaccharides, disaccharides, monosaccharides, and polyols.
16207111|NCT01339117|Other|High fermentable substrate diet|Diet high in fermentable oligosaccharides, disaccharides, monosaccharides and polyols
16207112|NCT01339104|Drug|Regorafenib (Stivarga, BAY73-4506)|All subjects will receive regorafenib administered from Day 1 -21 at a dose of 160 mg od (4 x 40 mg tablets) followed by a 7 days break in repeating cycles of 28 days. The drug is to be taken in the morning with approximately 240 mL of water after having a low fat breakfast. Holter ECGs with triplicate measurements will automatically be obtained at specified timepoints over 24 hours on days -1 and Cycle 1, Day 21. PK samples will be drawn on Cycle 1, Day 21. PK timepoints are time-matched with Holter ECG timepoints. 24 hour urine will be collected beginning on Cycle 1, Day 21. MUGA scans will be done at screening, Cycle 2 Day 21 (after 42 doses of BAY73-4506), then every 3 cycles starting in Cycle 5, and at end of treatment.
16207113|NCT01339091|Drug|Dalbavancin|IV Dalbavancin 1000 mg on Day 1 and 500 mg on Day 8
16207114|NCT01339091|Drug|Vancomycin / Linezolid|IV Vancomycin (1 gram Q 12 hours or 15mg/Kg Q 12 hours) with optional switch to oral linezolid (600 mg Q12 hours). Total duration of therapy is 10-14 days.
16207115|NCT01339078|Procedure|Plastic stenting|The patients receive plastic stenting after ortothopic liver transplantation with a choledocho-choledochal anastomosis, presenting with an anastomotic stricture. These patients will receive change of the stent every 3 months, for a total duration of 1 year.
16207116|NCT01339078|Procedure|Kaffes stenting|The patients receive Kaffes stenting after ortothopic liver transplantation with a choledocho-choledochal anastomosis, presenting with an anastomotic stricture. These patients will receive change of the stent every 6 months, for a total duration of 1 year.
16207117|NCT01339065|Drug|Ketamine|determining the effect of low dose sub anesthetic doze of ketamine and placaebo on post operative patients
16207118|NCT01339052|Drug|BKM120|
16207119|NCT01339052|Procedure|Surgery|Surgery
16207124|NCT01339039|Procedure|Surgery|After receiving 5-9 days of Plerixafor (AMD3100) monotherapy, patients proceed to surgery. After recovering from surgery, patients will proceed to 28-day post-surgical cycles of therapy (Plerixafor at the MTD established in Part 1, 21 days on / 7 days off; bevacizumab 10 mg/kg on days 1 & 15).
16207125|NCT01339026|Drug|Prasugrel|Day 1 loading 60mg Day 2 to 7 10mg o.d. Day 8 to 30 days 10mg od
16207126|NCT01339026|Drug|Plavix|Clopidogrel (Plavix) Day 1 Loading 600mg Day 2 to 7 day: 150mg o.d. Day 8 to 30 days: 75mg o.d.
16207127|NCT01339013|Device|Anesthetic Conserving Device (AnaConDa )|Standard HME was replaced by AnaConDa. AnaConDa has charcoal filter, HME does not.
16207128|NCT01339000|Drug|Glycosylated Recombinant Human Interleukin-7|Interleukin-7 (CYT 107) 20 microgram/kg / dose, by intramuscular (IM) injection
16207129|NCT01339000|Biological|Diphtheria/Tetanus Vaccine|Diphtheria/Tetanus Vaccine will be administered according to the random schedule per protocol.
16207130|NCT01339000|Biological|Polio Vaccine|Polio Vaccine will be administered according to the randomized schedule per protocol.
16207131|NCT01339000|Biological|Pneumococcal Vaccine|Pneumococcal Vaccine will be administered according to the randomization schedule per protocol.
16207132|NCT01339000|Biological|Hepatitis A Vaccine|Hepatitis A Vaccine will be administered according to the randomization schedule per protocol.
16207133|NCT01339000|Biological|Hepatitis B Vaccine|Hepatitis B vaccine will be administered according to the randomization schedule per protocol.
16207134|NCT01338987|Procedure|First Allogeneic Bone Marrow Transplant (BMT)|First Allogeneic Bone Marrow Transplant
16207135|NCT01338987|Drug|Leuprolide|Leuprolide: 30 mg intramuscular injection(for adult) or 11.25 mg (for patients <18 years) between day -13 and day -20 pre-bone marrow transplant but definitely prior to initiation of preparative regimen as a 4 month intramuscular injection for patients > 18 years and as a 3 month injection (adult preparation) for patients < 18 years
16207136|NCT01338987|Drug|18F FLT|For the first 23 patients undergoing 1st bone marrow transplant (BMT):[18F]fluorothymidine (18F FLT): 0.07 mCi/kg with a maximum of 3 mCi On day + 28 (+/- 5 days) For 2nd BMT: 18F FLT: 0.07 mCi/kg with a maximum of 3 mCi On day -1, + 28, day 60 and at relapse (+/- 5 days)
16207137|NCT01338987|Drug|Cyclophosphamide|Cyclophosphamide: 60 mg/kg intravenous (IV) on days -4 and -3 (for Adults > 22 years) or Cyclophosphamide: cyclophosphamide 50 mg/kg IV, Days -5, -4, -3, -2. (For Pediatric </= 22 years)
16207138|NCT01338987|Drug|Methotrexate|Methotrexate:10 mg/m(2) intravenous (IV) on day +1, and 5 mg/m(2) IV Days + 3, 6, 11
16207139|NCT01338987|Drug|Tacrolimus|Tacrolimus:0.02 mg/kg/day continuous intravenous infusion (CIV) on day -1.
16207140|NCT01338987|Radiation|Total Body Irradiation|Total Body Irradiation (TBI) 1200 cGy fractionate twice daily (lung block) Days -8, -7, -6, -5 (adult), -9, -8, -7, -6 (ped)
16207141|NCT01338987|Drug|Busulfan|Second choice is Busulfan (with goal steady state of 800-1000) with fludarabine or cyclophosphamide at myeloablative dosing or non-myeloablative dosing.
16207142|NCT01338987|Drug|Fludarabine|Given with Busulfan as alternative to cyclophosphamide in second transplant setting only
16207143|NCT01338987|Procedure|Second Allogeneic Bone Marrow Transplantation|Second Allogeneic Bone Marrow Transplantation
16207144|NCT01338974|Genetic|gene expression analysis|
16207145|NCT01338974|Genetic|proteomic profiling|
16207146|NCT01338974|Other|flow cytometry|
16207147|NCT01338974|Other|laboratory biomarker analysis|
16207148|NCT01338961|Procedure|Hypothermic CPB|Patients will be cooled to 31-32oC (nasopharyngeal) after the beginning of CPB. Rewarming will begin 10-15 min before release of aortic cross-clamp. The gradient between heat-exchanger and nasopharynx during rewarming will be maintained at 3oC. The rewarming will be stopped at 36,5oC
16207149|NCT01338948|Procedure|preoperative 3D-CT reconstruction|Robotic Surgery with CT reconstruction images using Tile-pro program.
16207150|NCT01338935|Drug|CW 002|"For Cohort 1, subjects receive a single bolus of 0.02 mg/kg CW 002 (i.v.) and neuromuscular function will be allowed to recover spontaneously for at least 5 half-lives.
~For Cohort 2, an estimated ED50 bolus dose of CW 002 (approximately 0.03 mg/kg) will be given i.v. followed by a second bolus of the same dosage*.
~For Cohort 3, an estimated ED 75 bolus dose of CW 002 (approximately 0.04 mg/kg) will be given i.v. followed by a second bolus of the same dosage *.
~For Cohort IV, an estimated ED 90 bolus dose of CW 002 (approximately 0.06 mg/kg) will be given i.v. followed by a second bolus of the same dosage*.
~*For Cohorts 2-4, a second bolus dose will be administered following a minimum of 5 half-lives of CW002 (based on PK data from Cohort 1)."
16207151|NCT01338935|Drug|CW 002|"Subjects receive an initial ascending bolus dose of CW 002 injection, and a second bolus followed by a continuous infusion initiated at the point of 25% recovery of twitch response. Infusion rate will be adjusted to maintain 97%- 99% suppression of twitch, but to avoid complete neuromuscular block. For the first 3 subjects of each cohort, CW 002 will be allowed to recover spontaneously. For the second 3 subjects, reversal will be performed at the appearance of 1st twitch using 0.05 mg/kg neostigmine and 0.01 mg/kg glycopyrrolate.
~Cohort 5- subject receives 2.0x ED95 dose of CW 002, followed by 1.5x ED95 dose and 30 min infusion of 2-10 mcg/kg/min of CW 002
~Cohort 6 - subject receives 3.0x ED95 dose of CW 002, followed by 1.5x ED95 dose and 60 min infusion of 2-10 mcg/kg/min of CW 002
~Cohort 7 - subject receives 4.0x ED95 dose of CW 002, followed by 1.5x ED95 dose and 90 min infusion of 2-10 mcg/kg/min of CW 002
~Bolus doses of ED95 are determined in Part I of the study."
16207152|NCT01338935|Drug|CW 002|"In Part III, safety, intubation efficacy, and PK will be evaluated in 2 cohorts (Cohorts 8 and 9) of 6 subjects each, who will undergo endotracheal intubation at 60 or 90 seconds after a bolus dose of CW002 injection at 3 to 4 times the ED95. For the first 3 subjects of each cohort, CW 002 will be allowed to recover spontaneously. For the second 3 subjects, reversal will be performed at the appearance of 1st twitch using 0.05 mg/kg neostigmine and 0.01 mg/kg glycopyrrolate.
~Cohort 8 - subject receives 3.0x ED95 dose of CW 002, and intubation attempt is made 90 seconds post-bolus.
~Cohort 9 - subject receives 4.0x ED95 dose of CW 002, and intubation attempt is made 60 seconds post-bolus."
16207153|NCT01338922|Device|Continuous subcutaneous insulin infusion therapy|Insulin is given continuously using an insulin pump. Devices are allowed having marketing approval. Insulins are permitted with marketing approval.
16207154|NCT01338922|Device|Multiple daily injection therapy|Multiple daily injection therapy with different devices and insulin types. Devices and insulin types have to have marketing approval.
16207155|NCT01338909|Drug|Prasugrel|Prasugrel 60mg immediate loading dose (Day 0)followed by 10mg/day starting from Day 1 until Day 5
16207157|NCT01338896|Drug|Rotigotine transdermal patch|8 mg/24 h, transdermal patch 8 mg/24 h, 2 days
16207158|NCT01338883|Drug|Cenicriviroc 100 mg|100 mg CVC plus Truvada
16207159|NCT01338883|Drug|Cenicriviroc 200 mg + Truvada|200 mg CVC plus Truvada
16207160|NCT01338883|Drug|Sustiva + Truvada|Sustiva plus Truvada
16207161|NCT01338870|Drug|Placebo|Tablets (n=4), 0 mg twice daily for 84 days
16207162|NCT01338870|Drug|25 mg PF-04991532|Tablets (n=1), 25 mg strength + tablets (n=3) 0 mg twice daily for 84 days
16207163|NCT01338870|Drug|75 mg PF-04991532|Tablets (n=3), 25 mg strength + tablets (n=1) 0 mg twice daily for 84 days
16207164|NCT01338870|Drug|150 mg PF-04991532|Tablets (n=1), 150 mg strength + tablets (n=3) 0 mg twice daily for 84 days
16207165|NCT01338870|Drug|300 mg PF-04991532|Tablets (n=2), 150 mg strength + tablets (n=2) 0 mg twice daily for 84 days
16207166|NCT01338870|Drug|Sitagliptin 100 mg|Tablets (n=1), 100 mg strength + tablets (n=3) 0 mg once daily in the morning for 84 days; and tablets (n=4) 0 mg once daily in the evening for 84 days.
16207167|NCT01338857|Drug|Sorafenib (Nexavar)|"Sorafenib (in tablet form) will be administered orally BID (approximately every 12 hours). Grapefruit juice is not allowed while taking sorafenib. A cycle of therapy is considered to be 28 days and there is no interruption between cycles. Patients may receive up to a total of 12 cycles provided that no off-protocol or off-study criteria are met.
~Children/adolescents (< 18 years of age, non-NF1): 200 mg/m2/dose PO twice daily (rounded to the nearest 50 mg increment as per Section 4.1) to a maximum of 400 mg PO twice daily
~Adults (greater than or equal to 18 years of age, non-NF1): 400 mg PO twice daily
~NF1 patients (regardless of age): 80 mg/m2/dose PO twice daily (rounded to the nearest 50 mg increment as per Section 4.1) to a maximum of 150 mg PO twice daily"
16207168|NCT01338844|Dietary Supplement|Myo-inositol|
16207169|NCT01338844|Dietary Supplement|D-chito-Inositol|
16207170|NCT01338831|Drug|LFA102|
16207171|NCT01338818|Drug|Ritalin LA (methylphenidate hydrochloride extended release)|Ritalin LA 20 mg or 30 mg (a racemic mixture of d- and l-thre-Methylphenidate Hydrocloride (MPH), Extended release hard capsules) taken orally once daily in doses of 40, 60, or 80 mg. For 40mg dose patients took (2) Ritalin LA 20mg daily, for 60mg patients took (2) Ritalin LA 30mg daily and for 80mg patients took (2) Ritalin LA 30mg daily + (1) Ritalin LA 20mg daily for their optimal dose.
16207172|NCT01338805|Drug|BGG492|
16207173|NCT01338792|Drug|oxaliplatin|Given IV
16207174|NCT01338792|Drug|pemetrexed disodium|Given IV
16207175|NCT01338792|Other|questionnaire administration|Ancillary studies
16207176|NCT01338792|Other|laboratory biomarker analysis|Correlative studies
16207177|NCT01338792|Genetic|reverse transcriptase-polymerase chain reaction|Correlative studies
16207178|NCT01338792|Genetic|polymorphism analysis|Correlative studies
16207179|NCT01338766|Procedure|Decompression using the iO-Flex® system|Decompression using the iO-Flex® system
16207180|NCT01338753|Other|Bevacizumab, docetaxel and doxorubicin followed by surgery|"The dosage form is Parenteral Injection (I/V) for all study drugs. Bevacizumab 15mg/kg in a single dose on day 1. Then 3 weeks later begin the cycles. On the day 1 of the cycle the patient receives Bevacizumab 15mg/kg, docetaxel 60mg/m2 and doxorubicin 50mg/m2.
~The cycles have a frequency of one every three weeks, and the protocol defines 4 cycles in total.
~The surgical procedure will be done 4-6 weeks after completion of chemotherapy."
16207181|NCT01338740|Drug|Adalimumab and Infliximab|Patients with moderately to severely active Crohn's disease with primary non-response or loss of response to Adalimumab switch to Infliximab.
16207182|NCT01338727|Behavioral|Breastfeeding Peer Counseling|3 Prenatal visits, daily in-hospital visits, 11 postpartum home visits.
16207183|NCT01338714|Other|Compound Herbal Formula (RHD-1)|100 ml/per day
16207184|NCT01338714|Other|dilute RHD-1|100 ml/per day
16207185|NCT01338701|Procedure|Traditional Chinese Acupuncture (TCA)|An acupuncturist will examine and evaluate subjects before inserting thin, sterile stainless steel needles at specific points on their body. Patients will receive 10 treatments over a 6 week period.
16207186|NCT01338701|Procedure|Auricular (Ear) Acupuncture|An acupuncturist will insert sterile stainless steel needles and an ASP ear needle into various points in subject's outer ear. The ASP is a shorter needle that will stay in the participant's ear for a few days. Patients will receive 10 treatments over a 6 week period.
16207187|NCT01338701|Other|Usual Care|Subjects do not receive acupuncture during the 6 week study time period. Instead, they continue to receive medical care for headaches and other symptoms. They can elect to receive up to 10 ear acupuncture treatments between the 6- and 12-week assessments.
16207188|NCT01338675|Drug|Busulfan|First dose: busulfan (120 mg/m2 ivs once daily) (if age<1 yr: 80 mg/ m2) Second to forth dose: according to the daily pharmacokinetic study
16207189|NCT01338649|Device|Bright Light Treatment (Sun Ray Sunbox SB-558)|Bright Light Treatment (Sun Ray Sunbox SB-558) using light intensity of 10,000 lux, administered during two 1 hour periods during the day.
16207190|NCT01338649|Device|Dim red light (Sun Ray Sunbox SB-558)|Dim red light box administered during two 1 hour periods during the day using
16207191|NCT01338636|Drug|Ambrisentan|5 mg orally every day for 4 weeks. At Week 4, if ambrisentan 5 mg was tolerated, the dose was increased to 10 mg every day for the remainder of the 24-week period.
16207192|NCT01338623|Drug|Tansulosine|capsule 0,4 mg
16207193|NCT01338610|Biological|ESBA105 ophthalmic solution|
16207194|NCT01338610|Other|ESBA105 vehicle|Inactive ingredients used as Run-In and placebo comparator
16207195|NCT01338597|Procedure|endoscopic thyroidectomy|endoscopic thyroidectomy via the breast approach. the difference between two arms is in the subcutaneous dissection area.
16207196|NCT01338584|Behavioral|Pelvic floor muscle training 3 weeks before radical prostatectomy|Participants in the intervention group need to attend the nurse-led clinic 6 times for practising pelvic floor muscle preoperatively instead of starting the exercise one day before surgery (usual management).
16207197|NCT01338584|Behavioral|Intensive preoperative pelvic floor muscle training|Patient started to learn pelvic floor muscle 3 weeks before surgery
16207198|NCT01338558|Drug|bevacizumab [Avastin]|5 mg/kg iv on Day 1 of each 2-week cycle until disease progression, unacceptable toxicity or withdrawal of consent
16207199|NCT01338558|Drug|cetuximab|400 mg /m2 iv on Day 1, followed by 250 mg/m2 every week until disease progression, unacceptable toxicity or withdrawal of consent
16207200|NCT01338558|Drug|mFOLFOX6|Standard mFOLFOX6 chemotherapy, 2-week cycles until disease progression, unacceptable toxicity or withdrawal of consent
16207201|NCT01338532|Other|A 12 week supervised exercise program and patient education|"The exercise protocol included exercises from former studies on comparable patient populations. The intensity of the strength- and flexibility exercises meets the American College of Sports Medicine's (ACSM) recommendations for developing and maintaining muscular fitness in adults. Patients was required to exercise for approximately 60 minutes, to-three days a week for 12 weeks. Patient's attendance to the exercise program (compliance) was registered.
~All patients included in the study participated in a patient education program which included two individual and three small-group sessions lasting one hour each time."
16207202|NCT01338532|Other|Patient education|All patients included in the study participated in a patient education program which included two individual and three small-group sessions lasting one hour each time.
16207203|NCT01338506|Behavioral|Concurrent Treatment with Prolonged Exposure (COPE)|12 weeks of concurrent prolonged exposure treatment for PTSD combined with cognitive behavioral therapy for substance use disorders (alcohol or drugs).
16207204|NCT01338493|Procedure|lumbar spinal arthroplasty + Maverick™|All patients will be subjected to a lumbar spinal arthroplasty. The anterior lumbar spine is approached through either a transperitoneal or retroperitoneal exposure. A complete anterior discectomy is performed and the Maverick™ Artificial Disc System is inserted to replace the damaged lumbar intervertebral disc.
16207205|NCT01338480|Other|video|The videos will be developed and contain information on the procedure, risks, benefits, and alternatives of the surgery. The knowledge measure instrument will also be developed.
16207206|NCT01338467|Device|EYEOP device|Cyclocoagulation using High Intensity Focused Ultrasound with EYEOP device
16207207|NCT01338454|Drug|transamin|TA was administered intravenously over a 5 min period at delivery of the anterior shoulder
16207208|NCT01338441|Drug|Erythromycin|4mg/Kg, IV during 20 min once
16207209|NCT01338441|Drug|Placebo|4mg/Kg, IV during 20 min once
16207210|NCT01338428|Behavioral|Enhanced AAA Sexual Assault Resistance Education|Resistance Program: 4x3-hour units. Unit 1 (Assess) accurate assessment of sexual assault risk. Provides: empirically-based information on situational and (male) behavioural danger cues; practice identifying risk and counteracting it. Unit 2 'Acknowledge[ment]' of risk when present. Includes: women's sexual rights; emotional barriers; tactics used by coercive men; practice. Unit 3 (Act) includes: assessing whether or not an escape is possible; research evidence on the effectiveness of resistance strategies; physical self-defense training. Unit 4 applies content to longer term relationships covering: comfort talking about sexuality, identification of sexual values, practices beyond intercourse, and articulation of relationship goals.
16207211|NCT01338428|Behavioral|Brochure|Current 'standard of care' at Canadian universities. Invitation to take and read brochures on sexual assault selected from those available on their Canadian university campus. All sites' brochures include general information on sexual assault and 'date-rape' drugs and post-rape legal and medical advice. The research assistant (RA) will ask the participants to take brochures, read them over, and to ask any questions they may have. Questions will be answered in a group setting and the participant will take home any brochures that she selected. Interaction between participants and the RA on the topic will be limited to 10-15 minutes and will be audio recorded for verification.
16207212|NCT01338415|Drug|Bosentan|Oral dispersible tablet administered as 2mg/kg two (b.i.d.) or three (t.i.d.) times per day
16207213|NCT01338402|Device|Lotrafilcon B contact lens|Silicone hydrogel contact lens
16207214|NCT01338402|Device|Lotrafilcon B contact lens with color|Silicone hydrogel contact lens with color
16207215|NCT01338402|Device|Phemfilcon A contact lens with color|Hydrogel contact lens with color
16207216|NCT01338389|Dietary Supplement|CITICOLINE|"Oral administration of CITICOLINE:
~Form: Powder for solution Dosage: 800mg per day duration: 5 years"
16207217|NCT01338389|Dietary Supplement|PLACEBO|"Oral administration of placebo:
~Form: Powder for solution duration: 5 years"
16207218|NCT01338376|Behavioral|Structured Education|"All of the educators who are responsible for the intensive group will be trained with the standard contents before the study kick-off.
~Educator Activities: insulin injection, SMBG instruction, self-learned manuals, periodic assessment for subjects, subject counseling, self-care education (healthy eating, exercise, weight control), prevention and treatment of hypoglycemia complication education ,newsletter delivered by SMS
~Physician Activity: frequent insulin titration"
16207219|NCT01338376|Behavioral|Conventional Diabetes Education|"The activities of the educators who are responsible for conventional group are identical with their routine clinical practice.
~Educator Activities: insulin injection, SMBG instruction, healthy eating , prevention and treatment of hypoglycemia
~Physician Activity: less frequent insulin titration"
16207220|NCT01338376|Drug|Scilin®M30|Subjects will be treated with Scilin®M30 twice daily
16207221|NCT01338350|Drug|AZD5423|Inhalation, suspension
16207222|NCT01338350|Drug|Placebo|Inhalation, solution
16207223|NCT01338337|Drug|Azacitidine|Azacitidine 75 mg/m2, for 5 days of each 20 day cycle. Transfusional support will be applied for symptomatic anaemia using clinical discretion and chelation therapy when ferritin is ≥ 1000 μgr/ml with the chelating agents allowed
16207224|NCT01338324|Drug|Simvastatin|Simvastatin 20 mg single dose on day 1
16207225|NCT01338311|Drug|salbutamol|200mcg twice daily for a total of 7 doses
16207226|NCT01338311|Drug|Placebo|200mcg twice a day for a total of 7 doses (3.5 days).
16207227|NCT01338298|Drug|Aripiprazole|Aripiprazole dosing will begin at 5 mg/day once daily and increased to 10mg by mouth once daily at the end of week 2 and then increased to 15 mg/day once daily at the end of week 8 in women who have not yet regained their menstrual period. If a woman gets her menstrual period on the 5 or 10 mg dose she will remain on this dose for the study.
16207228|NCT01338298|Drug|Placebo|The placebo will be sucrose filled capsules that are identical to the active medication. It is double blind so no one will know if the capsule is placebo or aripiprazole.
16207229|NCT01338142|Other|CCC|"600 mg (2 capsules of 300 mg) for oral use of 480 mg CCC (192 mg elemental calcium) intrinsically labeled with 15 mg 44Ca and 120 mg of inactive filler, sucrose.
~1.5 mg of 42Ca labeled CaCl2 through IV injection"
16207230|NCT01338142|Other|ACC|600 mg (2 capsules of 300 mg) for oral use containing 600 mg ACC (192 mg elemental calcium) intrinsically labeled with 15 mg 44Ca 1.5 mg of 42Ca labeled CaCl2 through IV injection
16207231|NCT01338129|Dietary Supplement|vitamin c|1000 mg of vitamin c for 45 days
16207233|NCT01338116|Other|antibiotic treatment of by TREAT/PCR|Management by TREAT/PCR. The data available at the time of patient recruitment will be entered into TREAT. TREAT will provide advice for the empirical antibiotic treatment and unless the caring physician can justify a deviation from this recommendation, TREAT's recommendation will be implemented (yes or no antibiotic treatment and type of antibiotic). TREAT will also recommend whether a blood sample for PCR should be obtained. Blood will be collected aseptically and the test will be performed once daily between 1000AM-1700PM (results available daily at 1700 PM). PCR results and a PCR-revised TREAT recommendation will be reported to the patient's physician in charge and treatment will be revised accordingly. On day 2, when results of blood cultures and other cultures become available TREAT will be re-consulted and will issue a new recommendation based on the full microbiological investigation (negative and positive results).
16207234|NCT01338103|Drug|Rituximab|intravenous (IV) Rituximab 1 gramX2, every (q) 2 weeks.
16207235|NCT01338090|Drug|89Zr-bevacizumab|Intravenous injection 120 MBq
16207236|NCT01338090|Drug|Everolimus|Oral use, 10 mg per day
16207237|NCT01338077|Drug|Sodium alginate|oral suspension, 50 mg/ml, 20 ml three times daily, 4 weeks
16207238|NCT01338077|Drug|Omeprazole|20 mg capsule, 1 capsule once daily, 4 weeks
16207239|NCT01338051|Biological|Gardasil|"Gardasil will be administered to 10-13 year old daughters and granddaughters of study participants according to manufacturers recommended schedule of administration. Gardasil is supplied as 0.5-mL suspension for intramuscular injection at the following schedule: 0, 2 months, 6 months.
~DOSAGE FORMS AND STRENGTHS • 0.5-mL suspension for injection as a single-dose vial and prefilled syringe."
16207240|NCT01338025|Drug|HAART regimen|The study participant continued their non-suppressive HAART regimen as prescribed by their primary provider.
16207241|NCT01338025|Drug|3TC or FTC monotherapy|The study participant was assigned to either 3TC or FTC monotherapy (the choice of 3TC or FTC was left to the provider.
16207242|NCT01338012|Biological|sipuleucel-T|Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).
16207243|NCT01337999|Other|blood draws|5 blood draws during ovulatory menstrual cycles in premenopausal women
16207244|NCT01337986|Drug|Dalfampridine/Placebo|Weeks 1-3: Dalfampridine 10mg (1 tablet) every 12 hours for 3 weeks. Weeks 4-5: 2 weeks of wash-out. Weeks 5-8: Placebo (sugar pill) 1 tablet every 12 hours for 3 weeks.
16207245|NCT01337986|Drug|Placebo/Dalfampridine|Weeks 1-3: Placebo (sugar pill) 1 tablet every 12 hours for 3 weeks. Weeks 4-5: 2 weeks of wash-out. Weeks 6-8: Dalfampridine 10mg (1 tablet) every 12 hours for 3 weeks.
16207246|NCT01337973|Behavioral|MI-CBT|Six individual psychotherapy sessions during the acute substance use disorder treatment phase integrating motivational interviewing and cognitive behavioral approaches
16207247|NCT01337973|Behavioral|MI-CBT+CC|Acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention
16207248|NCT01337973|Behavioral|E-TAU|Enhanced Treatment as Usual
16207249|NCT01337960|Behavioral|Seated Robot Training (SRT)|Participants at least 6 mos. post-stroke will use the ankle robot in a seated visuo-motor training paradigm. They will train on the robot 3x weekly for 6-weeks (18 sessions) by playing videogames with the paretic ankle. They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.
16207250|NCT01337960|Behavioral|Treadmill Locomotor-based Training (TMR)|Treadmill training with ankle robot group. Participants at least 6 mos. post-stroke will wear the ankle robot during treadmill locomotor training. They will walk on a treadmill with the ankle robot adjusted to promote paretic ankle engagement during 3 x weekly training sessions over 6 weeks (18 sessions). They will be evaluated on outcomes at baseline, post-6 weeks training, and again after a 6-week retention period with no training.
16207251|NCT01337960|Behavioral|Treadmill Only (TMO)|Treadmill only group. This group will consist of participants at least 6 mos. post-stroke who engage in treadmill training 3x weekly for 6 weeks without robotic support. They will be volunteers from another treadmill training study and evaluated on outcomes at baseline and post-6 weeks training. They will not receive retention testing at 12 weeks because they will be continuing with regular treadmill training beyond the 6-week period.
16207252|NCT01337947|Drug|Definity microbubbles|Definity microbubbles are used as a contrast agent to image blood flow in skeletal muscle
16207253|NCT01337934|Drug|Lactated Ringer|Lactated Ringer
16207254|NCT01337934|Drug|Albumin|Albumin 4%
16207255|NCT01337921|Dietary Supplement|Multi-strain Probiotic|Multi-strain Synbiotic: 1.5 billion CFU of Lactobacillus acidophilus, Bifidobacterium bifidum,and Bifidobacterium lactis WITH galacto-oligosaccharide(GOS)/fructo-oligosaccharide (FOS) combination at 1g/dL (0.9g/dL GOS/ 0.1g/dL FOS)
16207256|NCT01337895|Other|Low dairy|No more than 1 serving per day
16207257|NCT01337895|Other|High dairy|4 or more servings per day
16207258|NCT01337882|Other|Forearm venous occlusion plethysmography study|Forearm venous occlusion plethysmography to measure forearm blood flow during unilateral intrabrachial infusion of endothelium-dependent (bradykinin [100, 300 & 1000 pmol/min]; acetylcholine [5, 10 & 20 µg/min]) and -independent [sodium nitroprusside [2, 4 & 8 µg/min]; verapamil [10, 30 & 100 µg/min]) vasodilators. Each drug to be infused for 6 mins at each dose in increasing concentrations. 0.9% sodium chloride will be infused for 20 min between each individual drug to allow washout.
16207259|NCT01337869|Procedure|Bascom Cleft Lift|Patients are positioned prone. The skin incision is drawn on the natal cleft, marking out the area of skin to be excised. The skin from this side of the natal cleft is then elevated. The skin on the opposite side of the cleft then is undermined to a distance required to allow primary closure of the defect away from the midline without tension. The elevated skin island is excised. The sinuses remaining in the deeper tissues are curetted thoroughly. Hemostasis is maintained. A 12F low-suction drain is sited and fat of the natal cleft then is approximated by using an absorbable suture. The wound is closed with a 3-0 polypropylene suture.The drain remains in situ to time that drainage amount decreases below 20 ml/day. The suture is removed in the clinic 10 day after surgery.
16207294|NCT01337622|Procedure|Routine check of gastric residuals for early enteral feeding advancement|Discontinuation of gastric feeding and its advancement will be based on current practice of clinical examination of the abdomen and checking residual before every feed. Volume and color of gastric residual will be considered according to the current guideline.
16207260|NCT01337869|Procedure|Limberg Flap|Patients are positioned prone. The area to be excised is mapped-out, and the flap is designed. The area to be excised is mapped on the skin in a rhomboid form. The skin incision is deepened to the presacral fascia. Tissue is removed en bloc. After removing the rhombic excision, the Limberg fascia cutaneous flap is prepared through the right or left-side gluteus maximus fascia. The flap is fully mobilized and transposed medially to fulfill the rhombic defect without any tension. Hemosthasis is accomplished. A 12F low-suction drain is sited and wound is closed in two layers: the subcutaneous tissue with absorbable suture and the skin with 3/0 polypropylene. drain remains in situ to time that drainage amount decreases below 20 ml/day. The suture is removed in the clinic 10 day after surgery.
16207261|NCT01337856|Other|Hand hygiene protocol|Comparison of efficacy of 3 hand hygiene protocols
16207262|NCT01337843|Other|Wellness Workbook|A web-based cognitive behavioral pain management intervention to help individuals with chronic low back pain (CLBP) learn adaptive coping and pain management skills, increase physical activity and manage stress. This is a 10 week intervention. Participants use one chapter of the workbook each week. Each chapter takes approximately 1.5 hours to complete.
16207263|NCT01337843|Other|Pain Management Print Materials|Print materials comparable to the content within Wellness Workbook
16207264|NCT01337830|Other|Ariva® Silver Wintergreen|Study product containing 6 mg silver salt and 2 mg nicotine per dissolvable lozenge, administered orally as a single dose.
16207265|NCT01337830|Other|Silver Wintergreen|Comparator product containing 6 mg silver salt and no tobacco (i.e., no nicotine), administered orally as a single dose.
16207266|NCT01337817|Other|Ariva Silver Wintergreen|Study product containing 6 mg silver salt and 2 mg nicotine per dissolvable lozenge, administered orally as a single dose.
16207267|NCT01337817|Other|Ariva Wintergreen|Comparator product, a compressed dissolvable smokeless tobacco lozenge containing 2 mg nicotine administered orally as a single dose.
16207268|NCT01337804|Drug|omeprazole/sodium bicarbonate|Single 20 mg dose of omeprazole/sodium bicarbonate powder for oral suspension
16207269|NCT01337804|Drug|omeprazole magnesium|Single 40 mg capsule of omeprazole given orally
16207270|NCT01337791|Drug|Telbivudine treatment|Two arms in this study, One is Telbivudine 600 mg by mouth daily from late pregnancy to 28 weeks of post partum. Another arm is clinical observation only without telbivudine treatment
16207271|NCT01337778|Behavioral|Primary care for Daughters-in-Law|Primary care for DILs will be offered based on national and international standards and include access to critical support services for women who have experienced GBV.A comprehensive health examination for MILs will include a gynecological exam and screening for diabetes and hypertension, along with appropriate information, prescriptions, and/or referrals. We will routinely offer GBV-related resources, such as information, counseling, and referrals to all participants. Referrals will be documented using a Referral Care Form and reviewed on a routine basis to ensure that appropriate care is being provided and to detect any potential study-related risks.
16207272|NCT01337778|Behavioral|The Dil Mil Intervention|The Dil Mil intervention will be implemented during the second and third trimesters of the DILs' pregnancy. It consists of 2 half-day group sessions with DILs, 5 half-day group sessions with MILs, and one joint half-day session with DILs and MILs. The sessions are based on participatory learning and action principles and use stories, role-play, and discussion to enhance participants' knowledge, skills, and social support. Participants are encouraged to critically analyze their relationships and to develop and implement responses appropriate to their families and communities. The DIL-MIL joint session ends in a short celebration (based on a traditional ritual) in which MILs bless their DILs, and the MIL sessions culminate in a ceremony in which MILs' position in the family and community is recognized and celebrated. MILs draw up a family health action plan and take a pledge to reduce GBV and protect and promote their family's health.
16207273|NCT01337765|Drug|BEZ235 + MEK162|
16207274|NCT01337752|Drug|BHQ880|
16207275|NCT01337752|Drug|BHQ880 Placebo|Intravenous infusion
16207276|NCT01337752|Drug|bortezomib|intravenous injection
16207277|NCT01337752|Drug|dexamethasone|Oral
16207278|NCT01337739|Drug|Placebo Comparator|Placebo administration (.9 normal saline sterile)
16207279|NCT01337739|Drug|Active Comparator|Administration of Dexmedetomidine
16207280|NCT01337726|Behavioral|Combined Psychotherapy and Illness Management|Participants will have 10 weekly visits with a study clinician at their home and by phone. They will focus on their self care and illness management as well as how to manage their mood/cope emotionally. Follow up assessments will occur at 26 and 52 weeks.
16207281|NCT01337726|Behavioral|Illness Management Only|Participants in this group will have 10 weekly sessions with a study clinician at home and by phone. They will focus only on how they manage their illness. Follow up assessments will occur at 26 and 52 weeks.
16207282|NCT01337713|Other|Swedish Massage|Swedish massage, 45 minutes, 2 x per week for 6 weeks
16207283|NCT01337713|Other|Light Touch|Light touch, 45 minutes, 2 x week for 6 weeks
16207284|NCT01337700|Drug|Milnacipran|Patients will receive a titrated dose of milnacipran increasing to a maximum of 100mg a day over the 12 week study period. Dosing will be based on a fixed schedule that will be monitored using a side effect profile.
16207285|NCT01337700|Drug|Placebo|Subjects will be given placebo tablets at dosing corresponding to the fixed schedule between 12.5mg and 100mg.
16207286|NCT01337687|Drug|Intranasal Oxytocin|Oxytocin administered intranasally twice a day via 1 12 unit puff to each nostril, totaling 48 IU a day.
16207287|NCT01337687|Drug|Placebo|Saline will be administered intranasally twice a day via 1 puff per nostril, totaling 48 IU a day.
16207288|NCT01337674|Drug|MK-4618|Once daily oral dose of MK-4618 100 mg (two 50 mg tablets) on Days 1 through 7
16207289|NCT01337674|Drug|Placebo for MK-4618|Once daily oral dose of placebo for MK-4618 100 mg (two 50 mg tablets) on Days 1 through 7
16207290|NCT01337674|Drug|Metoprolol|Previously prescribed daily dose of open-label metoprolol for the duration of the study
16207291|NCT01337674|Drug|Amlodipine|Previously prescribed daily dose of open-label amlodipine for the duration of the study
16207292|NCT01337635|Drug|Vitamin D|Ergocalciferol 300,000 IU single oral dose Cholecalciferol 400 IU orally every day for 6 weeks
16207293|NCT01337622|Procedure|No check of gastric residuals for early enteral feeding advancement|Discontinuation of gastric feeding and its advancement will be based on clinical examination of the abdomen and gastric aspirates containing blood or significant vomiting.
16207376|NCT01336985|Drug|Irinotecan|
16207295|NCT01337609|Drug|Ganeden BC30|2 billion CFU per capsule; One pill daily for 60 days
16207296|NCT01337609|Other|Placebo (sugar pill)|1 pill daily for 60 days
16207297|NCT01337609|Other|Ganeden BC30, Placebo (sugar pill)|Ganeden BC30 (2 billion CFU per capsule), One capsule daily for 30 days Sugar Pill (placebo), One capsule daily for 30 days
16207298|NCT01337596|Drug|LY2951742|Administered subcutaneously
16207299|NCT01337596|Drug|Placebo|Administered subcutaneously
16207300|NCT01337583|Other|Dapivirine|Vaginal ring containing 25mg dapivirine; one ring inserted every 28 days for at least 15 months
16207301|NCT01337583|Other|Placebo|Vaginal Ring containing no drug substance
16207302|NCT01337583|Drug|Dapivirine|
16207303|NCT01337570|Other|Dapivirine|Vaginal ring containing 25mg dapivirine; one ring inserted every 28 days for at least 15 months
16207304|NCT01337570|Other|Placebo|Vaginal Ring containing no drug substance
16207305|NCT01337570|Drug|Dapivirine|
16207306|NCT01337557|Drug|Bepotastine|1.5% bid
16207307|NCT01337544|Other|HAPLOIDENTICAL IL-15 STIMULATED NK CELLS|ONE MEGADOSE 30 DAYS AFTER TRANSPLANTATION (DOSE WILL DEPEND ON PATIENT BODY WEIGHT)
16207308|NCT01337531|Drug|Gonal-F, Fostimon|dosage form
16207309|NCT01337531|Drug|Gonal-F, Fostimon|injection, daily, 10-15 days
16207310|NCT01337518|Drug|EZN-4176|EZN-4176 can be administered as a weekly one-hour i.v. infusion; weekly for 3 weeks followed by a 1 week rest; or 1 out of 2 weeks (every other week)
16207311|NCT01337505|Drug|INNO-206|INNO-206 at dosages of 230, 350, and 450 mg/m2 (doxorubicin equivalents of 165, 260, and 325 mg/m2) will be administered as a 30 minute IVI on Day 1 of each cycle.
16207312|NCT01337492|Drug|Nexavar|400 mg of Sorafenib
16207313|NCT01337466|Radiation|[124I]FIAU|This is a single dose study of 2 mCi [124I]FIAU in healthy volunteers or subjects with prosthetic joint infection of the knee or hip who will undergo serial PET-CT scanning.
16207314|NCT01337440|Drug|UDCA|"Sitagliptin: 50 mg, po, qd for 12 weeks, then UDCA add-on therapy for additional 12 weeks.
~UDCA dosage: dosing from 600 mg for initial 4 weeks. Then, if there is no adverse effect, UDCA is escalated to 900 mg, po, tid."
16207315|NCT01337440|Drug|Sitagliptin|"UDCA for 12 weeks, then Sitagliptin add-on therapy for additional 12 weeks.
~UDCA dosage: dosing from 600 mg for initial 4 weeks. Then, if there is no adverse effect, UDCA is escalated to 900 mg, po, tid."
16207316|NCT01337427|Drug|BIIB017|BIIB017 is supplied as a liquid in pre-filled syringes to deliver 0.5 mL of 0.25 mg/mL (125 mcg dose) of 20 kDa mPEG-O-2-methylpropionaldehyde-modified human IFN β-1a in 20 mM acetic acid/sodium acetate buffer pH 4.8, 150 mM arginine hydrochloride, and 0.005% Polysorbate 20.
16207317|NCT01337414|Behavioral|VMS diary booklet|
16207318|NCT01337414|Behavioral|Standard of Care|
16207319|NCT01337401|Drug|Cediranib|30mg once daily, oral until disease progression
16207320|NCT01337401|Drug|Placebo|30mg, once daily, oral until 24 weeks or disease progression if sooner
16207321|NCT01337375|Drug|peginterferon alfa 2a [Pegasys]|sc weekly
16207322|NCT01337375|Drug|peginterferon alfa-2a [Pegasys]|iv weekly
16207323|NCT01337375|Drug|peginterferon alfa-2a [Pegasys]|sc twice weekly
16207324|NCT01337375|Drug|peginterferon alfa-2a [Pegasys]|iv twice weekly
16207325|NCT01337362|Procedure|Insulin clamp|Patients will be exposed to low bloodsugar
16207326|NCT01337349|Drug|Placebo|Sugar Pill 400mg taken orally three times a day for 6 months
16207327|NCT01337349|Drug|Pentoxifylline|Pentoxifylline 400mg taken orally Three times a day for 6 months
16207328|NCT01337336|Drug|fluticasone propionate/salmeterol xinafoate|combination fluticasone priopionate and salmeterol xinafoate 250/50mcg
16207329|NCT01337336|Drug|Anticholinergics|tiotropium; ipratropium alone; or ipratropium + albuterol
16207330|NCT01337323|Drug|Fluticasone furoate nasal spray|fluticasone furorate intranasal steroid spray
16207331|NCT01337310|Drug|Tesetaxel|The starting dose for the first 3 patients treated will be 24 mg/m2. In the absence of dose-limiting toxicity, the dose will be increased by 3 mg/m2 for the next group of 3 patients treated. Interpatient dose escalation will continue in this manner to 27 and 31 mg/m2 until the maximum tolerated dose or the maximum dose allowed per protocol (31 mg/m2) is reached and 6 patients are treated at this dose.
16207332|NCT01337297|Device|transcranial Direct Current Stimulation|transcranial Direct Current Stimulation (tDCS) will be applied by electrodes (5 x 7 cm2), with intensity of 2 mA, during 20 min, with cathode over the left dorsolateral prefrontal cortex (F3 site) and anode placed in the contralateral dorsolateral prefrontal cortex (F4 site).
16207333|NCT01337271|Procedure|SBT- PSV|An Spontaneous breathing trial for 30 minutes on pressure support ventilation, which is a commonly used strategy to evaluate readiness for extubation
16207334|NCT01337271|Procedure|SBT - NAVA|An spontaneous breathing trial (SBT) on the ventilatory mode NAVA, with ventilatory support titrated to be similar to the support provided during an SBT on pressure support mode (PSV). NAVA captures the electrical activity of the diaphragm with an esophageal-gastric catheter, and uses the electrical signal to deliver inspiratory pressure proportional to the intensity of patient effort, as well as to trigger and cycle assisted mechanical breaths.
16207335|NCT01337258|Drug|Dutasteride|dutasteride 0.5mg daily.
16207336|NCT01337258|Drug|Placebo|Men taking placebo daily
16207337|NCT01337245|Drug|Snake (Micrurus) North American immune F(ab')2 Equine|5 vials of study drug reconstituted and diluted to 250 mL Normal Saline and administered intravenously.
16207338|NCT01337232|Behavioral|Complex sentence treatment protocol|Treatment: listening, speaking, reading, and writing activities that teach three types of complex sentences. Individual sessions are 40 minutes in length, delivered by or under the supervision of a certified, trained speech-language pathologist.
16207339|NCT01337219|Drug|Tobramycin|
16207340|NCT01337206|Device|Stenting with ELLA Biodegradable stent|Treating benign esophageal lesions with the placement of a degradable stent
16207341|NCT01337206|Procedure|Standard Dilations|Treating benign esophageal lesions with standard dilation therapy
16207342|NCT01337193|Other|Pelvic floor exercises with biofeedback|Exercises will be performed with assistance of biofeedback cueing
16207343|NCT01337193|Other|Pelvic floor muscle exercises|Exercises will b performed with verbal cueing of investigator.
16207377|NCT01336985|Procedure|Chemoembolization|
16207378|NCT01336985|Device|Drug-Eluting Beads|
16207379|NCT01336985|Procedure|Biopsy|
16207344|NCT01337167|Biological|V419|V419 (Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Outer Membrane Protein Complex], and Hepatitis B [Recombinant] Vaccine) 0.5 mL intramuscular injection at 2, 4, and 6 months of age
16207345|NCT01337167|Biological|DAPTACEL™|DAPTACEL™ 0.5 mL intramuscular injection at 15 months of age
16207346|NCT01337167|Biological|PedvaxHIB™|PedvaxHIB™ 0.5 mL intramuscular injection at 15 months of age
16207347|NCT01337167|Biological|Prevnar 13™|Prevnar 13™ 0.5 mL intramuscular injection at 2, 4, 6, and 15 months of age
16207348|NCT01337167|Biological|RotaTeq™|RotaTeq™ 2 mL oral dose at 2, 4, and 6 months of age
16207349|NCT01337167|Biological|PENTACEL™|PENTACEL™ 0.5 mL intramuscular injection at 2, 4, and 6 months of age
16207350|NCT01337167|Biological|Recombivax HB vaccine|Recombivax HB vaccine 0.5 mL intramuscular injection at 2 and 6 months of age
16207351|NCT01337167|Biological|ActHIB™|ActHIB™ 0.5 mL intramuscular injection at 15 months of age
16207352|NCT01337154|Drug|Tamibarotene|Tablet, 6 mg/m2, oral, divided into twice a day dosing.
16207353|NCT01337154|Drug|Placebo|Tablets, orally, daily
16207354|NCT01337141|Other|Control|7 face-to-face visits.
16207355|NCT01337141|Device|Telecare system|5 telematic visits and 2 face-to-face visits.
16207356|NCT01337128|Procedure|Carotid endarterectomy (CEA)|Carotid endarterectomy (CEA) will be performed on the patients
16207357|NCT01337128|Procedure|Carotid stenting (CAS)|Carotid Stenting (CAS) will be performed on these patients.
16207358|NCT01337128|Procedure|Neurocognitive functions|Neurocognitive functions will be measured pre-operatively and after 3 weeks, 6 months and 1 year.
16207359|NCT01337128|Procedure|Levels of biomarkers|Levels of biomarkers (Protein S100B) will be examined pre- , peri- and post-operatively after 2 hours, 6 hours and 24 hours.
16207360|NCT01337128|Procedure|Detection of peri-operative embolization|A Transcranial Doppler Ultrasonography will be used to detect peri-operative embolization.
16207361|NCT01337128|Procedure|Validation results|On a subgroup of 20 patients a MRI-scan will be done pre- and post-operatively after 48 hours and 3 weeks.
16207362|NCT01337115|Procedure|SNB plus CFNB|A single shot sciatic nerve block (SNB) is performed with 25 ml of 0.2% ropivacaine before surgery in addition to an isolated continuous femoral nerve block (CFNB) in the control group
16207363|NCT01337115|Procedure|CFNB|A continuous femoral nerve block is performed for peri-operative analgesia and a bolus of 30 ml of ropivacaine 0.375% is injected before induction of general anesthesia and surgery starts. An infusion of 8ml/h of ropivacaine 0.2% is started in post anesthesia care unit (PACU) and maintained for 48h
16207364|NCT01337102|Procedure|Physician Receives QoL results|Patient completes the Lung Cancer QoL scale on the Palm held computer device and the Physician receives the print out of the results.
16207365|NCT01337102|Procedure|Physician Does not receive the results|Patient completes the Lung Cancer QoL scale on the Palm held computer device and the Physician does not receive the print out of the results.
16207366|NCT01337089|Drug|Nabiximols|
16207367|NCT01337076|Device|cochlear implant|Cochlear implant surgery
16207368|NCT01337063|Other|Mentored medication reconciliation quality improvement|"Based on expert recommendations from a recent conference on medication reconciliation sponsored by the Society of Hospital Medicine and funded by AHRQ, investigators will engage a steering committee and conduct a second conference to operationalize these recommendations into a set of best practice guidelines, standards, and tools to be adapted by each of 6 participating sites. After training mentors and developing data collection tools, a mentored quality improvement project will be conducted for 21 months, in which each site works to improve medication reconciliation using the toolkit and with mentorship in the form of two site visits and monthly phone calls."
16207369|NCT01337050|Drug|PF-03446962|PF 03446962 given by a 1 hour IV infusion. Each patient will initially receive the first dose on Cycle 1 Day 1 with a 28 day observation period. Cycle 2 will start on Day 29. The dosing interval will be 14 days for Cycle 2 and subsequent cycles.
16207370|NCT01337037|Device|VATS lobectomy using modified equipments|"the procedure of this group is the same with standard VATS lobectomy group.the VATS surgical equipments used in the group are designed according to the experience of chinese lobectomy surgery. All the patent applications of the surgical equipments are granted. proprietor of the patents is Jun Wang, head of Department of Thoracic surgery of people's hospital, peking university.
~Details of the modified equipments: Lobectomy Equipments Pack (Manufacturer B.J.ZH.F.Panther Medical Equipment Co.,Ltd.) consists of 8 basic surgical equipments, which are crafoord dissecting and ligature forcep, Yankauer suction tube, mixter dissecting and ligature forceps(long),mixter dissecting and ligature forceps(short), atraumatic-grip aorta-aneurysma clamp with toothing De Bakey, De Bakey atraumatic-grip vascular forcep, Bozemann tite grip needle holder, Winter placenta and ovum forcep."
16207371|NCT01337037|Procedure|VATS lobectomy using less staples|VATS lobectomy with at most 4 staples used, aimed at reduced hospital cost.This procedure is similar with the standard VATS lobectomy procedure without staples limits. The lobar vessels and bronchus are stapled. However, the interlobar fissures should be deal with electronic cautery, harmonic scalpel,or suturing.
16207372|NCT01337037|Procedure|Standard VATS lobectomy|VATS lobectomy without new equipments and limitation of staples, same with the current procedure of VATS lobectomy performed in thoracic departments of Peking university people's hospital and the Collaborators. All procedures were conducted under general anesthesia with double lumen intubation. The thoracoscope was introduced through 7th or 8th intercostals space on the mid-axillaries line. The 4 cm long utility incision was made on the 4th or 5th intercostals space anterior axillary's line without rib-spreading. A third retraction incision located on the 7th or 8th intercostals space sub-scapular line. The surgeon stands on the ventral side of patient using an electrocautery hook and a suction device through the utility incision. Anatomic lobectomy was performed with systemic mediastinal lymph node dissection for lung cancer patients.
16207373|NCT01337037|Procedure|Open lobectomy|standard lobectomy procedure by thoracotomy approach
16207374|NCT01337011|Other|autologous CD133pos stem cell application|The study aims to show efficacy of both intra-myocardial autologous CD133pos bone marrow cell application as well as intra-coronary CD133pos cell application in patients with symptomatic ischemic heart disease. In addition, efficacy between the two delivery routes will be compared.
16207375|NCT01336998|Dietary Supplement|arginine|oral L-arginine supplementation 261mg/kg/day (1,5mmol/kg/day), one dose daily ,from the 3rd day of life until the 28th day of life
16207380|NCT01336972|Drug|Tolvaptan|Tolvaptan was supplied as 15 and 30 mg tablets.
16207381|NCT01336959|Drug|BCT197 Part A|open label single dose administration of 10mg BCT197, 2 hours prior to surgery
16207382|NCT01336959|Drug|Placebo|Single dose matching placebo administered 2 prior to surgery
16207383|NCT01336959|Drug|BCT197 Part B|BCT197 50mg single dose administered 2 hours prior to surgery
16207384|NCT01336946|Behavioral|Psycho educational and behavioural group sessions|10 psycho educational and behavioural group sessions on topics like the Food Triangle, healthy eating, the importance of physical activity, healthy eating on a limited budget, implementing physical activity into the daily life, the influence of advertisements...
16207385|NCT01336946|Behavioral|Walking session|A weekly supervised walking session (30 minutes) in a 10-week period.
16207386|NCT01336933|Drug|prednisone|Given PO
16207387|NCT01336933|Drug|cyclophosphamide|Given IV
16207388|NCT01336933|Drug|etoposide|Given PO or IV
16207389|NCT01336933|Drug|Vincristine|Given IV
16207390|NCT01336933|Drug|pralatrexate|Given IV
16207391|NCT01336933|Other|laboratory biomarker analysis|Correlative studies
16207392|NCT01336933|Genetic|comparative genomic hybridization|Correlative studies
16207393|NCT01336933|Genetic|gene expression analysis|Correlative studies
16207394|NCT01336933|Genetic|nucleic acid sequencing|Correlative studies
16207395|NCT01336933|Genetic|mutation analysis|Correlative studies
16207396|NCT01336933|Other|immunohistochemistry staining method|Correlative studies
16207397|NCT01336933|Genetic|microarray analysis|Correlative studies
16207398|NCT01336933|Genetic|RNA analysis|Correlative studies
16207399|NCT01336920|Drug|carfilzomib|Given IV
16207400|NCT01336894|Procedure|therapeutic conventional surgery|Undergo surgery
16207401|NCT01336894|Radiation|iodine I 125|Undergo seed implant radiotherapy
16207402|NCT01336894|Radiation|stereotactic body radiation therapy|Undergo radiotherapy
16207403|NCT01336881|Genetic|RNA analysis|
16207404|NCT01336881|Genetic|gene expression analysis|
16207405|NCT01336881|Genetic|microarray analysis|
16207406|NCT01336881|Genetic|nucleic acid sequencing|
16207407|NCT01336881|Other|diagnostic laboratory biomarker analysis|
16207408|NCT01336842|Drug|Panobinostat, Cisplatin, Pemetrexed|"Drug: Panobinostat Oral (by mouth) once daily every Monday, Wednesday, and Friday for the first two weeks of each three week cycle (as per dose escalation schedule (dose levels 1 and 2: AUC 5; dose levels 3 and 4: AUC 6). Number of cycles: 6 maximum.
~Drug: Cisplatin IV (in the vein) on day 1 of a 21-day cycle Number of cycles: 6 maximum. Drug: Pemetrexed IV (in the vein) on day 1 of a 21-day cycle Other: Correlative studies Biomarker Analysis: blood collected pre-study and Cycles 2-6, Day 1."
16207409|NCT01336829|Drug|ETR/telaprevir|Treatment A: ETR 200 mg twice a day from Day 1 to Day 10 + a single dose in the morning on Day 11. Treatment B: telaprevir 750 mg every 8 hours from Day 1 to Day 17 + 2 doses (morning and afternoon) on Day 18, and ETR 200 mg twice a day from Day 8 to Day 17 + a single dose in the morning on Day 18.
16207410|NCT01336829|Drug|TMC278/telaprevir|Treatment C: TMC278 25 mg once day from Day 1 to Day 11. Treatment D: telaprevir 750 mg every 8 hours from Day 1 to Day 18, and TMC278 25 mg once daily from Day 8 to Day 18.
16207411|NCT01336829|Drug|telaprevir/ETR|Treatment A: ETR 200 mg twice a day from Day 1 to Day 10 + a single dose in the morning on Day 11. Treatment B: telaprevir 750 mg every 8 hours from Day 1 to Day 17 + 2 doses (morning and afternoon) on Day 18, and ETR 200 mg twice a day from Day 8 to Day 17 + a single dose in the morning on Day 18.
16207412|NCT01336829|Drug|telaprevir/TMC278|Treatment C: TMC278 25 mg once day from Day 1 to Day 11. Treatment D: telaprevir 750 mg every 8 hours from Day 1 to Day 18, and TMC278 25 mg once daily from Day 8 to Day 18.
16207413|NCT01336816|Other|Ariva Silver Wintergreen|Study product containing 6 mg silver salt and 2 mg nicotine per dissolvable lozenge, administered orally as a single dose.
16207414|NCT01336816|Other|Placebo Wintergreen|Placebo Wintergreen lozenge containing no tobacco, nicotine, or silver salt, administered orally as a single dose.
16207415|NCT01336803|Drug|Feraheme|5 mg/kg by intravenous (IV) administration
16207416|NCT01336803|Procedure|Magnetic Resonance Imaging (MRI) scan|Standard of Care magnetic resonance imaging (MRI) scans using GE 1.5T and 3T MRI scanners/
16207417|NCT01336764|Behavioral|Cognitive reappraisal and breathing retraining|They will be induced to rapidly achieve reduced autonomic arousal through use of a graphics-rich biofeedback procedure and simultaneously engage in the generation and rehearsal of cognitive reappraisal scripts under the coaching of project therapist also in the vehicle.
16207418|NCT01336764|Behavioral|Control|Unguided listening to radio/music.
16207419|NCT01336751|Drug|Insulin glargine|solution for subcutaneous injection
16207420|NCT01336751|Drug|75% insulin lispro protamine suspension and 25 % insulin lispro injection|suspension for subcutaneous injection
16207421|NCT01336738|Drug|Placebo|Tablets (n=6), 0 mg, once daily for 84 days
16207422|NCT01336738|Drug|150 mg PF-04991532|Tablets (n=1), 150 mg + tablets (n=5), 0 mg, all once daily for 84 days
16207423|NCT01336738|Drug|450 mg PF-04991532|Tablets (n=3), 150 mg + tablets (n=3), 0 mg, all once daily for 84 days
16207424|NCT01336738|Drug|750 mg PF-04991532|Tablets (n=5), 150 mg + tablets (n=1), 0 mg, all once daily for 84 days
16207425|NCT01336738|Drug|Sitagliptin 100 mg|Tablets (n=1), 100 mg strength + tablets (n=5), 0 mg, all once daily for 84 days
16207426|NCT01336725|Behavioral|Teaching life style changes|Single group: Teaching, group sessions, physical activity
16207427|NCT01336725|Other|Active participation|Obesity group attend 10 group sessions,are informed about and discuss needed life style changes such as weight loss and participate in physical activity and cooking.
16207428|NCT01336725|Other|Teaching|Morbid obesity group attend 40 hours of group sessions
16207429|NCT01336712|Procedure|Peripheral Blood Stem Cell Transplant|"Total Body Irradiation 1200cGy (150cGy given in 8 fractions twice a day six hours apart on days -4, -3, -2 and -1.
~Fludarabine 30 mg/m^2 given once a day for 3 days on days -7, -6 and -5 Cyclophosphamide 50mg/kg given one a day on days +3 and +4"
16207430|NCT01336699|Other|Placebo|Placebo comparator: 1 or 1.5 ml of sterile normal saline 0.9% added to 30 mL of 0.9% sterile normal saline, given orally.
16207551|NCT01335737|Behavioral|aerobic training|12 weeks of aerobic training, 4 times/week
16207431|NCT01336699|Biological|WRSs2|WRSs2 is a live, attenuated Shigella sonnei vaccine product, given orally at five escalating doses from 1x10^3 colony-forming units (cfu) to 1x10^7 cfu.
16207432|NCT01336699|Biological|WRSs3|WRSs3 is a live, attenuated Shigella sonnei vaccine product, given orally at five escalating doses from 1x10^3 colony-forming units (cfu) to 1x10^7 cfu.
16207433|NCT01336686|Drug|Arhalofenate|Arhalofenate 400 mg once daily for 4 weeks
16207434|NCT01336686|Drug|Arhalofenate|Arhalofenate 600 mg once daily for 4 weeks
16207435|NCT01336686|Drug|Placebo comparator|Matching placebo once daily for 4 weeks
16207436|NCT01336686|Drug|Colchicine|0.6 mg colchicine daily for flare prophylaxis
16207437|NCT01336660|Biological|Equine F(ab')2 antivenom|A single dose of 4 vials of Equine F(ab')2 antivenom will be administered intravenously over 10 minute
16207438|NCT01336660|Other|Intensive care support plus placebo|Intensive care support as needed plus placebo
16207439|NCT01336647|Drug|Group A - Low-Dose Ha44 0.37% w/w|Low Dose Ha44 Gel applied to scalp and hair for 10 minutes
16207440|NCT01336647|Drug|Group B - High Dose Ha44 Gel 0.74% w/w|High Dose Ha44 Gel applied to scalp and hair for 10 minutes
16207441|NCT01336647|Drug|Group C - Placebo|Placebo- vehicle Ha44 Gel without active ingredient applied to scalp and hair for 10 minutes
16207442|NCT01336634|Drug|Dabrafenib|Dabrafenib study treatment will be provided by GSK as 50 mg and 75 mg hydroxypropyl methylcellulose (HPMC) capsules. Each capsule contains 50 mg or 75 mg of free base (present as the mesylate salt).
16207443|NCT01336634|Device|Trametinib|Trametinib study treatment will be provided as 0.5 mg and 2 mg tablets. Each tablet will contain 0.5 mg or 2 mg of trametinib parent (present as the DMSO solvate)
16207444|NCT01336621|Drug|Retigabine IR|Flexible dose between 300 mg/day (minimum) and 1200 mg/day (maximum)
16207445|NCT01336608|Drug|Fluticasone Furoate/Vilanterol|Inhaled corticosteroid/long acting beta-agonist
16207446|NCT01336608|Drug|Vilanterol|Inhaled long acting beta-agonist
16207447|NCT01336608|Drug|Placebo|Placebo
16207448|NCT01336595|Device|Zirconium (Zirconium Genesis II)|Oxidized Zirconium femoral component of Genesis II TKR system is used.
16207449|NCT01336595|Device|Cobalt-Chrome (Cobalt Chrome Genesis II)|Cobalt Chrome Femoral Component of Genesis II TKR system is used
16207450|NCT01336582|Drug|taxotere|70 mg/m2 for age of ≥ 65
16207451|NCT01336569|Drug|Travoprost 0.004%/timolol maleate 0.5% fixed combination|
16207452|NCT01336556|Procedure|Oral appliance|Anterior mandibular repositioner: used for two months
16207453|NCT01336543|Drug|Chemotherapy following concurrent Chemoradiotherapy|"NSCLC (Non-Small Cell Lung Cancer)
~PE (Cisplatin 50mg/m2 on days 1,8,29,36 Etoposide 80mg/m2 days 1-3 and 29-31)
~Radiation 59.4 Gy with 2 cycles of PE
~(Non-squamous histology) Pemetrexed consolidation 500mg/m2 every 21 days for 4 cycles
~(Squamous histology) Gemcitabine consolidation 1000mg/m2 days 1,8, every 21 days for 4 cycles"
16207454|NCT01336530|Drug|oxetacaine, aluminium and magnesium hydroxide|20mg/10ml oxetacaine, 196mg/10ml magnesium hydroxide, 582mg/10ml aluminium hydroxide. Suspension for oral intake 3-6 times per day for a maximum of 11 weeks.
16207455|NCT01336530|Drug|oxetacaine|20mg/10ml oxetacaine. Suspension for oral intake 3-6 times per day for a maximum of 11 weeks.
16207456|NCT01336530|Drug|magnesium and aluminium hydroxide|196mg/10ml magnesium hydroxide, 582mg/10ml aluminium hydroxide. Suspension for oral intake 3-6 times per day for a maximum of 11 weeks.
16207457|NCT01336530|Other|Vehicle|Placebo suspension for oral intake 3-6 times per day for a maximum of 11 weeks.
16207458|NCT01336478|Procedure|Infusion of donor derived ex-vivo selected NK cells to patients after transplant|Infusion of donor derived ex-vivo selected NK cells to patients after transplant
16207459|NCT01336478|Procedure|Haematology / Blood chemistry sampling|Haematology / Blood chemistry sampling, collection of blood for ancillary lab research
16207460|NCT01336465|Drug|placebo|Repeating subcutaneous injection
16207461|NCT01336465|Drug|rhuMAb Beta7|Repeating subcutaneous injection
16207462|NCT01336452|Radiation|DCE MRI|DCE (dynamic contrast enhanced) MRI will be obtained just before CCRTx and immediately after finishing CCRTx with 0.1mmol/kg of MR contrast media; CEUS will be obtained just before CCRTx, immediately after finishing CCRTx, and 1 month after CCRTx with 2.4 mL of SonoVue. Blood sampling for biomarker analysis will be performed just before CCRTx, immediately after finishing CCRTx, and 1 month after CCRTx (20mL)
16207463|NCT01336439|Drug|Botulinum toxin type A (Meditoxin®)|"In this study, the botulinum toxin type A (Meditoxin®)was supplied as a freeze-dried powder of 200U, and was reconstituted with 4ml of sterile saline to a concentration of 5U/0.1ml.
~After pre-injection polysomnography, botulinum toxin type A was injected into each side bilaterally using a 1ml-syringe with a 29-gauge, and a 1/2-inch needle. The M group had an injection in masseter muscle. The MT group had an injection in masseter and temporal muscle. A total of 25U of botulinum toxin type A was injected into each site.
~After 4 weeks, the subjects had a post-injection polysomnography."
16207464|NCT01336413|Drug|Pregnenolone|Pregnenolone 50 mg BID x 14 DAYS, followed by Pregnenolone 150 mg BID x 14 DAYS, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial
16207465|NCT01336413|Drug|Placebo|Same as active comparator, except placebo dispensed.
16207466|NCT01336400|Other|single cell haplotyping|We aim to collect single blastomeres from spare IVF embryos of 30 couples to optimize and test methods for single cell haplotyping. We aim to collect 20 and 10 couples coming to the fertility centre for FISH- or PCR-based PGD respectively. In both groups, at least 5 different indications for PGD will be collected. Per couple, we will perform 10 SNP-arrays: 2 for the couple donating the embryo, 4 for family members (often parents of the couple) and 4 for blastomeres since we aim to pick 2 cells from 2 embryos per couple. For five couples, 2 blastomeres of all available embryos will be aspirated to validate and optimize the phasing methods. Finally, for some embryos, all blastomeres will be picked to be able to prove the reproducibility of single cell haplotyping.
16207467|NCT01336387|Drug|retinoid 9cUAB30|Given PO
16207468|NCT01336387|Other|placebo|Given PO
16207469|NCT01336387|Other|pharmacological study|Correlative studies
16207470|NCT01336387|Other|laboratory biomarker analysis|Correlative studies
16207471|NCT01336387|Other|cancer prevention|Disease prevention
16207517|NCT01335997|Drug|ER niacin/laropiprant (ERN/LRPT)|ER niacin 1 g/laropiprant 20 mg oral tablet taken once daily
16207552|NCT01335737|Behavioral|Wait list|wait list control condition
16207472|NCT01336361|Other|Survey|A one-time paper survey was mailed to subjects, along with a cover letter, explanation of the research study, and contact and informed consent information. A reminder postcard was sent to subjects approximately one week later, encouraging return of the completed survey.
16207473|NCT01336348|Drug|Prasugrel|60 mg loading dose given orally at presentation
16207474|NCT01336348|Drug|Tirofiban|Tirofiban will be given at high bolus dose only of bolus followed by 2 H infusion in a randomized manner (1:1 ratio).
16207475|NCT01336335|Device|CPAP|CPAP
16207476|NCT01336322|Drug|Metformin|Metformin 850 mg bid
16207477|NCT01336322|Drug|Sitagliptin|Sitagliptin 100 mg qd
16207478|NCT01336322|Drug|Sitagliptin + Metformin|sitagliptin 100mg + metformin 850mg
16207479|NCT01336309|Behavioral|Yoga Research Tool|We will be collecting data from a literature search, focus groups, cognitive interviews, and an online survey to build a measure for yoga researchers.
16207480|NCT01336296|Drug|mycophenolic acid|Comparing mycophenolic acid 720mg orally twice daily starting 2 weeks prior to transplant to mycophenolic acid 720mg orally twice daily starting day of transplant.
16207481|NCT01336283|Other|Endurance training|compare the efficacy of endurance, strength, and the combination of strength and endurance exercise training in patients with COPD.
16207482|NCT01336283|Other|Strength training|compare the efficacy of endurance, strength, and the combination of strength and endurance exercise training in patients with COPD.
16207483|NCT01336283|Other|Combined training|compare the efficacy of endurance, strength, and the combination of strength and endurance exercise training in patients with COPD.
16207484|NCT01336270|Other|biological collection|to collect some human cell samples in melanoma
16207485|NCT01336257|Other|SEBASTIAN Clinical Decision Support System (CDSS)|SEBASTIAN is an example of a clinical decision support technology that supports the latest, service-based architectural approach to CDSS implementation. Developed at Duke University, SEBASTIAN is a clinical decision support Web service whose interface is now the basis of the HL7 Decision Support Service draft standard SEBASTIAN places a standardized interface in front of clinical decision support knowledge modules and makes only limited demands on how relevant patient data are collected or on how decision support inferences are communicated to end-users
16207486|NCT01336244|Drug|GLPG0778|capsules containing 50 or 100 mg of GLPG0778
16207487|NCT01336244|Drug|placebo|multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule
16207488|NCT01336218|Drug|fostamatinib|oral tablets, 150mg (3 X 50mg) single dose per period
16207489|NCT01336218|Drug|rifampicin|oral tablets, 600mg (2 X 300mg) 8 doses over 8 days
16207490|NCT01336205|Drug|NKTR-118|25 mg oral tablet once daily
16207491|NCT01336205|Drug|Usual care|As prescribed by the investigator
16207492|NCT01336192|Drug|Gemcitabine|Gemcitabine 1250mg/m^2 Day 1 and 8, 28 days per cycle until PD
16207493|NCT01336192|Drug|Best supportive care|Best supportive care
16207494|NCT01336179|Procedure|Salvadora persica|twice daily use, two minutes interval
16207495|NCT01336179|Procedure|Toothbrush|Twice daily use two minutes interval
16207496|NCT01336166|Biological|split-virion, non-adjuvanted H1N1 vaccine of 15 μg|120 adults were assigned to receive 1 dose of 15μg split-virion, non-adjuvanted H1N1 vaccine.
16207497|NCT01336166|Biological|split-virion, non-adjuvanted H1N1 vaccine of 30 μg|120 adults were assigned to receive 1 dose of 30μg split-virion, non-adjuvanted H1N1 vaccine.
16207498|NCT01336166|Biological|split-virion, non-adjuvanted H1N1 vaccine of 45 μg|120 adults were assigned to receive 1 dose of 45μg split-virion, non-adjuvanted H1N1 vaccine.
16207499|NCT01336166|Biological|Placebo control|120 adults were assigned to receive 1 dose of placebo.
16207500|NCT01336153|Drug|MLC601|group A (100 patients; NeuroAid 400mg, 4 capsules 3 times daily) or for 3 month
16207501|NCT01336153|Drug|Placebo|group B (50 patients; placebo, 4 capsules 3 times daily) for 3 months
16207502|NCT01336140|Drug|Aminophylline|75 mg of intravenous aminophylline
16207503|NCT01336140|Drug|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
16207504|NCT01336127|Behavioral|Occupational Therapy|Patients in the experimental group will receive 10 weeks (maximum 16 hours) occupational therapy according to a treatment protocol, which is based on the Dutch evidence based guideline for occupational therapy in Parkinson's Disease and refined for this study.
16207505|NCT01336101|Device|EPIC™ Self-Expanding Nitinol Vascular Stent|SFA/Popliteal Artery stenting
16207506|NCT01336088|Drug|ADX48621|oral administration
16207507|NCT01336088|Drug|Placebo|oral administration
16207508|NCT01336075|Procedure|Percutaneous radiofrequency catheter ablation|Percutaneous radiofrequency catheter ablation around the rights and lefts pulmonary veins, with complete circumferential ablation.
16207509|NCT01336075|Procedure|Mini invasive thoracoscopic radiofrequency ablation|Video-assisted thoracoscopic approach for electrical isolation of the pulmonary veins bilaterally and left atrial appendage excision or exclusion.
16207510|NCT01336062|Drug|Nanoparticle Albumin-Bound Paclitaxel|this study evaluate 3 dose level of nab-paclitaxel:100 mg /m2;125 mg /m2;80 mg /m2;
16207511|NCT01336049|Drug|Nimotuzumab|Nimotuzumab 200mg/week
16207512|NCT01336023|Drug|insulin degludec/liraglutide|Insulin degludec/liraglutide treatment will be initiated and titrated (individually adjusted) twice weekly according to the mean self measured plasma glucose (SMPG) (fasting). Insulin degludec/liraglutide is injected subcutaneously (under the skin) once daily.
16207513|NCT01336023|Drug|insulin degludec|Insulin degludec treatment will be initiated with 10 U and titrated (individually adjusted) twice weekly according to the mean SMPG (fasting). Insulin degludec is injected subcutaneously (under the skin) once daily.
16207514|NCT01336023|Drug|liraglutide|Liraglutide will be started with 0.6 mg and subsequent 0.6 mg weekly dose escalation to 1.8 mg. Liraglutide dose of 1.8 mg/day will be continued for the remaining part of the trial. Liraglutide is injected subcutaneously (under the skin) once daily.
16207515|NCT01336010|Drug|Peginterferon alfa-2a|PEG-IFN 180 mcg in 0.5 ml (prefilled syringes) administered subcutaneously (SC) once weekly
16207516|NCT01336010|Drug|Ribavirin|Genotype 1: 1000mg or 1200mg p.o. daily in split doses (1000mg for patients weighing <75kg and 1200mg for patients weighing ≥ 75kg) Genotypes 2/3: 800mg daily p.o. daily in split doses for genotype 2 and 3 patients
16207550|NCT01335750|Other|Multipurpose Solution #4|Saline Solution
16207518|NCT01335997|Drug|ER niacin/laropiprant/simvastatin (ERN/LRPT/SIM)|ER niacin 1 g/laropiprant 20 mg/simvastatin 10 mg oral tablet taken once daily
16207519|NCT01335997|Drug|Simvastatin (SIM)|Simvastatin 10 mg oral tablet taken once daily
16207520|NCT01335997|Drug|Placebo Run-In|Placebo matches both ER niacin 1 g/laropiprant 20 mg oral tablet and ER niacin 1 g/laropiprant 20 mg/simvastatin 10 mg oral tablet; placebo is taken once daily
16207521|NCT01335997|Drug|SIM-matching placebo|Placebo for simvastatin 10 mg oral tablet taken once daily
16207522|NCT01335984|Procedure|Telemonitoring|"The subjects who are assigned in the Telemonitoring group will be provided Blood Pressure monitor, body composition analyzer, and remote monitoring device.
~The subjects who are assigned in the Telemonitoring group should visit the site once per every 2 months (8 weeks), and they should measure their blood pressure using a provided blood pressure monitor twice a day during study period (once after first morning urination and once before going to bed). After measurement of blood pressure and body composition, the subjects should make the transmission terminals of remote monitoring device situate near transmission terminal of Smart Care PC and transmit measured information through Smart Care PC into a centralized server of Smart Care Center."
16207523|NCT01335984|Procedure|Telemonitoring & Telemedicine|"The subjects who are assigned in the Telemonitoring & Telemedicine group should perform the same remote monitoring procedures as the subjects in the Telemonitoring group.
~Since the remote visit substitute for a face to face visit, subjects should reserve the time for remote visit in each clinical trial center. A primary doctor or remote medical doctor should provide medical consultation to the subjects through videotelephony using the remote monitoring device and then issue electronic prescriptions."
16207524|NCT01335984|Other|control group|"- The subjects who are assigned in the control group will be provided blood Pressure Monitor (Self BP measuring).
~The subjects who are assigned in the control group should perform the same blood pressure measurement (2 times a day) same as the test group during the study, and measured results should be recorded in a diary of self blood pressure measurement. In addition, the subjects should visit the site once per every two months (8 weeks)."
16207525|NCT01335971|Drug|Sulforaphane 25|25 micromoles (4.4 mg) sulforaphane daily by mouth
16207526|NCT01335971|Dietary Supplement|Sulforaphane 150|150 micromoles (26.6 mg) sulforaphane daily by mouth
16207527|NCT01335971|Other|Placebo|Microcrystalline cellulose once daily by mouth
16207528|NCT01335958|Drug|DMUC5754A|Escalating intravenous dose
16207529|NCT01335945|Procedure|Cryoablation|All subjects will receive cryoablation of the celiac plexus with Galil Medical cryoablation systems and needles under imaging guidance.
16207530|NCT01335932|Drug|IV Ganciclovir|For first 5 days, dosing of intravenous ganciclovir is 10 mg/kg daily, given as 5 mg/kg every 12 hours (adjusted for renal function). After first 5 days (up to 28 days) IV ganciclovir 5 mg/kg QD ( adjusted for renal function). A minimum interval of 6 hours is required between the first and second dose.
16207531|NCT01335932|Drug|Placebo|"For first 5 days, dosing of intravenous placebo is daily, given every 12 hours. After first 5 days (up to 28 days), IV placebo QD. A minimum interval of 6 hours is required between the first and second dose.
~The placebo is an IV solution that does not contain any active medications."
16207532|NCT01335906|Other|Information|The experimental information consists of receiving verbal and written evidence-based information about the benefits and risks of mammography screening program. The standard information consists of receiving the information that public institutions provide to the women invited to the screening program.
16207533|NCT01335893|Drug|Indocyanine Green|Dose will be diluted in saline solution. This will be a single dose given before the surgery intravenously.
16207534|NCT01335880|Behavioral|Coupons for use within the next week|Participants who attend an exercise class will receive a coupon for a free exercise class to be used within the next week.
16207535|NCT01335880|Behavioral|Coupons for use within the next 3 months|Participants who attend an exercise class will receive a coupon to attend an exercise class for free within the next 3 months.
16207536|NCT01335867|Drug|Vigabatrin|Vigabatrin escalated to 3 grams daily for 8 weeks
16207537|NCT01335867|Drug|Placebo|Placebo pills
16207538|NCT01335854|Behavioral|Web-based Access to CPAP Data|Participants will have web-based access to their CPAP usage for each 24 hours of treatment. They will be asked to view this data each day during the first week of the study, and then as frequently as they choose after the first week.
16207539|NCT01335854|Behavioral|Web-based Access to CPAP Data with Financial Incentive|Participants will have web-based access to their CPAP usage for each 24 hours of treatment. They will be asked to view this data each day during the first week of the the study, and then as frequently as they choose after the first week. There will be a payment of $30 during the first week for each day a participant uses CPAP for more than 4 hours the previous night and logs on to the website.
16207540|NCT01335841|Device|Navigation station coupled with a 3D fluoroscopy|After randomization, patients will be operated with the conventional method either with navigation station. In the conventional method, the orthopedic surgeon based on anatomical criteria to establish its implants. It uses an image intensifier in 2D mode to monitor the implementation of the implants. In computer assisted surgery, the surgeon uses a navigation station that allows real-time flow instruments to guide its implementation of the implants. It uses an image intensifier in 3D mode on the one hand to achieve a first series of image that will be used for navigation and also to monitor the implementation of the implants.
16207541|NCT01335828|Device|Medical ultrasound device (ShearWave system)|"Echography (all modes) and elastography ShearWave system"
16207542|NCT01335789|Drug|Oxytocin|40 IUs
16207543|NCT01335789|Drug|Saline|40 IUs
16207544|NCT01335776|Behavioral|Mindfulness-Based Stress Reduction|This intervention is provided over the course of eight, weekly, 90 minute sessions, plus one 6 hour silent retreat.
16207545|NCT01335776|Behavioral|Cognitive Behavior Therapy|This treatment is delivered to small groups over the course of 8 weekly, 90 minute sessions
16207546|NCT01335763|Drug|Insulin glargine|10 units at bedtime of insulin glargine will be prescribed to the patients who has HbA1c levels of 7.5-11%. Insulin glargine dose is going to be titrated by increments of 1 unit daily by the patient to achieve a morning fasting glucose of <=5.5mmol/L
16207547|NCT01335750|Other|Multipurpose Solution #1|B&L Renu Fresh Multipurpose Solution
16207548|NCT01335750|Other|Multipurpose Solution #2|Optifree Replenish Multipurpose Solution
16207549|NCT01335750|Other|Mutlipurpose Solution #3|Ciba ClearCare Multipurpose Solution
16207553|NCT01335724|Drug|Diclofenac diethylamine 1.16% gel|Diclofenac diethylamine 1.16% gel
16207554|NCT01335724|Drug|Placebo gel|Placebo gel
16207555|NCT01335711|Drug|ChronVac-C + SOC|"IMP: I.m. administration of 500 μg plasmid DNA vaccine CHRONVAC-C (solution for injection) administered i.m. in combination with electroporation using MedPulser® DDS on 2 occasions with 4 weeks in between followed by standard of care (SOC) initiation after 14 - 42 days.
~SOC: Peg-IFN-α-2a (180 μg per week) and Ribavirin (1000 mg/day for subjects with a BW of < 75 kg and 1200 mg/day for subjects with a BW of > 75 kg)"
16207556|NCT01335711|Drug|SOC|SOC: Peg-IFN-α-2a (180 μg per week) and Ribavirin (1000 mg/day for subjects with a BW of < 75 kg and 1200 mg/day for subjects with a BW of > 75 kg)
16207557|NCT01335698|Drug|Atazanavir Sulphate|
16207558|NCT01335698|Drug|Ritonavir|
16207559|NCT01335685|Drug|Ixazomib|Ixazomib capsules
16207560|NCT01335685|Drug|Melphalan|Melphalan tablets
16207561|NCT01335685|Drug|Prednisone|Prednisone tablets
16207562|NCT01335659|Device|Fractional flow reserve|Fractional flow reserve measured by pressure wire
16207563|NCT01335659|Device|IVUS|"intravascular ultrasound
~:IVUS was performed in a standard fashion using an automated motorized pullback system (0.5mm/s) with commercially available imaging catheter"
16207564|NCT01335646|Procedure|Lumbar Microdiscectomy|lumbar discectomy within 1 month of randomization
16207565|NCT01335646|Other|Physiotherapy, Epidural injections, Education, Pain Medications, Anti-inflammatories|Physiotherapy following standardized protocol Epidurals - Depomedrol 80 mg plus 10cc of 0.35% Lidocaine Education to occur at each visit Medications may include: NSAIDS; Acetaminophen with codeine or oxycodone or tramadol; Amitriptyline or Neurontin or Pregabalin
16207566|NCT01335620|Drug|Raltegravir|400 mg twice daily
16207567|NCT01335620|Drug|Tenofovir|245 mg once daily
16207568|NCT01335620|Drug|Emtricitabine|200mg once daily
16207569|NCT01335607|Drug|Samatasvir tablet|Two samatasvir (IDX184) 50 mg tablets (100 mg single oral dose)
16207570|NCT01335607|Drug|Samatasvir capsule|Two samatasvir (IDX184) 50 mg capsules (100 mg single oral dose)
16207571|NCT01335594|Procedure|clinical, endoscopical and manometric evaluation|clinical evaluation: questionnaire endoscopical analysis manometry
16207572|NCT01335581|Device|Q-Switched Nd:YAG Laser (RevLite)|Laser treatment added to a microdermabrasion and topical lightening agent regimen
16207573|NCT01335568|Procedure|Hepatocyte Matrix Implant|Open surgical procedure with biopsy of liver tissue and pancreatic tissue for proceeding in institutional GMP laboratory. Implantation of autologous hepatocytes and islet cells on scaffolds into the small bowel mesentery. Usually 10 to 20 implants are used.
16207574|NCT01335542|Procedure|Peri-Articular Injection|Pre-operative anesthesia/analgesia: meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)
16207575|NCT01335542|Procedure|Epidural Pathway (PCEA+FNB)|Pre-operative anesthesia/analgesia: meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV
16207576|NCT01335529|Drug|Boceprevir, Peg-interferon alfa 2b and Ribavirin|"Screen period from Week-8
~Standard treatment from day 0 to week 4 (W4)
~Three-drug-regimen (Boceprevir introduction) from W4 to W8
~HCV RNA determination at W8 determines treatment group and participation duration:
~If undetectable HCV RNA at W8, it is a complete virological response: 3 drug-regimen is continued until W48, then there is a follow-up period up to W72 and SVR analysis,
~If HCV RNA ≤ 1000IU/mL at W8, it is an incomplete virological response. The 3-drug-regimen is continued until W72, when another analysis is done."
16207577|NCT01335516|Other|Glypressin (terlipressin)|Study drug (without placebo)
16207578|NCT01335503|Dietary Supplement|AN-PEP|Endoprotease enzyme (AN-PEP)
16207579|NCT01335490|Other|Cook stoves, either Biolite wood stove, or liquified petroleum gas stove plus fuel|The cooking stoves will reduce air emissions significantly in the home, resulting in improved infant health. It will be given to the mother in the second or third trimester.
16207580|NCT01335477|Drug|placebo|placebo matching BIBF 1120 BID
16207581|NCT01335477|Drug|BIBF 1120|BIBF 1120 BID (twice daily)
16207582|NCT01335464|Drug|placebo|placebo matching BIBF1120, BID
16207583|NCT01335464|Drug|BIBF 1120|BIBF1120 BID (twice daily)
16207584|NCT01335451|Drug|AZD5213|Four increasing doses for young and two increasing doses for elderly subjects. Subject will receive single dose of AZD5213 oral solution (Day 1) and then start the once daily repeated doses from Day 3 to 12 for 10 days
16207585|NCT01335451|Drug|Placebo|Placebo solution, single dose (Day 1) and repeated dose from Day 3 to 12 for 10 days
16207586|NCT01335438|Device|Cementless (Nexgen)|Cementless fixation of Nexgen CR TKR
16207587|NCT01335438|Device|Cemented (Nexgen)|Cemented fixation of Nexgen CR TKR
16207588|NCT01335412|Biological|Japanese Encephalitis Virus vaccine, inactivated, adsorbed|2 x 6mcg / 0.5mL intramuscular injection, Day 0 and 28 (Primary series) or 1x 6mcg / 0.5mL intramuscular injection (Booster)
16207589|NCT01335399|Drug|Lenalidomide|Capsules, Oral, 25 mg, once daily, on Days 1-21, Repeat every 28 days until subject meets criteria for discontinuation of study drug
16207590|NCT01335399|Drug|Dexamethasone|Tablets, Oral, 40 mg, weekly, on Days 1, 8, 15, 22, Repeat every 28 days until subject meets criteria for discontinuation of study drug
16207591|NCT01335399|Drug|Dexamethasone|Tablets, Oral, 28 mg, once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
16207592|NCT01335399|Drug|Dexamethasone|Tablets, Oral, 40 mg, once daily, on Days 8 & 22 (cycles 3-18); Days 8, 15, 22 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
16207593|NCT01335399|Drug|Dexamethasone|Solution, Intravenous (IV), 8 mg, Once daily, on Days 1, 8, 15, 22 (cycles 1&2) ; Days 1 &15 (cycles 3-18); Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
16207594|NCT01335399|Biological|Elotuzumab (BMS-901608; HuLuc63)|Solution, Intravenous (IV), 10 mg/kg, weekly, on Days 1, 8, 15, 22 (cycles 1&2); Days 1 and 15 (cycles 3-18), Repeat every 28 days until subject meets criteria for discontinuation of study drug
16207595|NCT01335399|Biological|Elotuzumab (BMS-901608; HuLuc63)|Solution, Intravenous (IV), 20 mg/kg, Day 1 (cycle 19 and beyond), Repeat every 28 days until subject meets criteria for discontinuation of study drug
16207596|NCT01335386|Drug|KLYX|
16207597|NCT01335386|Drug|Glycerine|
16207598|NCT01335373|Drug|Metronidazole/Miconazole (Neo-Penotran Forte, BAY86-5276)|Patients older than 18 years with previously taken decision of their gynecologist to prescribe Neo-Penotran Forte according to registered indications, and microbiological tests were performed.
16207599|NCT01335360|Drug|Nevirapine|200mg twice daily of nevirapine
16207600|NCT01335347|Biological|ND1.1|adenovirus with the dsRNA adjuvant, dried and put into capsules
16207601|NCT01335347|Biological|Placebo control|Capsules of the same size and shape as experimental groups
16207602|NCT01335334|Drug|bismuth subcitrate potassium, metronidazole,tetracycline hydrochloride and omeprazole|Pylera capsule contains bismuth subcitrate potassium, 140 mg (q.i.d.), metronidazole, 125mg (q.i.d.), tetracycline hydrochloride, 125mg (q.i.d.). Generic omeprazole (20mg, b.i.d) tablets
16207603|NCT01335321|Drug|Hylan GF-20 alone|A intraarticular injection of 6ml of Hylan GF-20 (Synvisc)
16207604|NCT01335321|Drug|Triamcinolone|A Intraarticular injection of 6ml of Hylan GF-20 (Synvisc) + 1ml of triamcinolone (Triancil)
16207605|NCT01335308|Behavioral|Standard Care|Practitioners will receive 2 hour obesity lecture and ½ day protocol training. Families recruited are given parent education materials. Outcomes will be collected at 1 year and 2 years after enrollment
16207606|NCT01335308|Behavioral|Moderate Dose Motivational Interviewing|Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner. Outcomes will be collected at 1 year and 2 years after enrollment
16207607|NCT01335308|Behavioral|Higher Dose Motivational Interviewing|Practitioners receive 2 days of Motivational Interviewing and Behavioral Therapy Training and ½ day protocol training. Families recruited receive 4 x MI visits with the pediatric practitioner and 6 x visits (in phone or in person) with a Registered Dietitian, also trained in Motivational Interviewing. Outcomes will be collected at 1 year and 2 years after enrollment
16207608|NCT01335295|Drug|Flavocoxid|Flavocoxid capsules TTD 500 mg/die or 1000 mg/die for 1 year
16207609|NCT01335269|Drug|BI 853520|BI 853520 once daily in a dose escalation schedule
16207610|NCT01335256|Drug|BAY1000394|BAY1000394 will be administered orally twice a day (bid) in a 4 week on / 2 week off schedule.
16207611|NCT01335243|Procedure|The Transforaminal Lumbar Interbody Fusion (TLIF) surgery|The TLIF surgery use a per-operating artificial substitute specific biomaterial: autologous osteoblasts punctured on iliac crest and put on a collagen support waxed with tri-calcium phosphate (which is osteoconductive) to perform a intervertebral body fusion.
16207612|NCT01335217|Procedure|Transcutaneous Electrical Nerve Stimulator (TENS)|External trigeminal nerve stimulation (TNS) as an adjunctive treatment for adults with major depressive disorder (MDD) co- occurring with posttraumatic stress disorder (PTSD) when added onto antidepressant medications
16207613|NCT01335204|Drug|Cabazitaxel plus bavituximab|Cabazitaxel (25 mg/m2) will be administered IV on Day 1 of each 21-day treatment cycle, and bavituximab (3 mg/kg) will be administered as an IV infusion on a weekly basis (Cycle 1 Day 2, all other cycles Day 1; day 8; day 15) for 8 cycles.
16207614|NCT01335191|Biological|TUTI-16 (1.0 mg)|Two subcutaneous injections of TUTI-16 (1.0 mg) at Day 0 and Week 3.
16207615|NCT01335191|Other|Placebo|Two subcutaneous injections of Placebo at Day 0 and Week 3.
16207616|NCT01335178|Behavioral|Intervention|The intervention consisted of the following elements: (a) Three motivational interviews, scheduled for baseline, one month, and three months; (b) Feedback on air quality in the home (PM2.5 was measured using a Sidepak and/or a Dylos monitoring device, and air nicotine was measured using passive air nicotine dosimeters); (c) Feedback on child's exposure via hair nicotine; (d) a website designed especially for the project [parents.org.il];and (e) various self-help materials, including a booklet, a magnet about TSE, and air fresheners.
16207617|NCT01335165|Drug|ALXN1102|Single Ascending Dose IV
16207618|NCT01335165|Drug|ALXN1103|Single Ascending Dose IV or SC
16207619|NCT01335152|Behavioral|Coping with Breast Cancer web-based workbook|10 chapter web-based workbook that teaches stress management, cognitive behavioral coping skills and relaxation training.
16207620|NCT01335139|Biological|Sublingual immunotherapy (SLIT)|Participants randomized to receive sublingual allergen tablet immunotherapy with placebo injections.
16207621|NCT01335139|Biological|Subcutaneous immunotherapy (SCIT)|Participants randomized to receive subcutaneous injection immunotherapy with placebo tablets. Subcutaneous immunotherapy was included as a positive control.
16207622|NCT01335139|Other|Placebo|Participants randomized to double-placebo tablets and injections. This group was included as a negative control.
16207623|NCT01335126|Other|Emulsion type artificial tear|2 types of artificial tears
16207624|NCT01335087|Other|Standard care|Patients with conservative treatment: (Group 2). This group will also be instructed in hygienic-dietary measures, standard care of cardiovascular risk factors and sleep hygiene counselling.
16207625|NCT01335087|Device|continuous positive airway pressure|Patients with CPAP treatment (Group 1): CPAP pressure titration will be performed by automated equipment before discharge. It will follow the methodology described by our group (Mass et al. Alternative Methods of titrating continuous positive airway pressure: a large multicentre study. American Journal of Respiratory and Critical Care Medicine (2004) vol. 170 (11) pp. 1218-1224). This group will also be instructed in hygienic-dietary measures recommended for all patients, standard care of cardiovascular risk factors and sleep hygiene counselling.
16207626|NCT01335074|Drug|Temsirolimus + Sorafenib|200mg bid Sorafenib + 15, 20 or 25 mg Temsirolimus
16207627|NCT01335061|Biological|Nonacog alfa|Period 1: During on-demand period, dosing at the discretion of investigator.
16207628|NCT01335061|Biological|Nonacog alfa|Period 2: During the prophylaxis period, 100 IU/kg once weekly
16207629|NCT01335048|Drug|atorvastatin and clopidogrel|Atorvastatin 80 mg daily + clopidogrel 150 mg daily
16207630|NCT01335048|Drug|Clopidogrel|Clopidogrel 150 mg daily
16207631|NCT01335035|Drug|deferasirox|
16207632|NCT01335022|Behavioral|lecture|6 lectures on cardiovascular disease covering obesity, diet & exercise, smoking cessation, coronary artery disease, hypertension, heart failure, diabetes, peripheral vascular disease, and stroke.
16207633|NCT01335009|Biological|MORAb-004 (monoclonal antibody)|Subjects will receive one cycle of treatment with MORAb-004, administered intravenously, on Days 1, 8, 15, and 22 (4 administrations per cycle). Additional cycles will continue without interruption until disease progression occurs or clinical or symptomatic progression as suggested by an investigator.
16207634|NCT01334983|Behavioral|REST|Instruction in an individualized rapid easy strength training (isotonic with therabands) and pedometer-based walking programs.
16207635|NCT01334957|Drug|Intravenous ibuprofen|800 mg intravenous ibuprofen administered intravenously over 5-10 minutes
16207636|NCT01334944|Drug|Intravenous ibuprofen|400 mg or 800 mg intravenous ibuprofen administered intravenously over 5-10 minutes
16207637|NCT01334931|Radiation|Large field of view arm|Patients will be allocated in the large field of view arm. Coronary angiography will be performed with large field of view lens (25 cm)
16207638|NCT01334931|Radiation|Medium field of view|Patients will be allocated in the medium field of view arm. Coronary angiography will be performed with medium field of view lens (20 cm)
16207639|NCT01334918|Drug|regadenoson|Administered by intravenous bolus.
16207640|NCT01334918|Radiation|technetium Tc99m sestamibi /technetium Tc99m tetrafosmin|Administered by intravenous infusion
16207641|NCT01334918|Radiation|Contrast|Administered by intravenous infusion.
16207642|NCT01334918|Procedure|Single Photon Emission Computed Tomography|Procedure/Surgery
16207643|NCT01334918|Procedure|Multidetector Computed Tomography|Procedure/Surgery
16207644|NCT01334905|Drug|YM178|oral
16207645|NCT01334892|Drug|Cyclosporine Inhalation Solution|Cyclosporin for inhalation twice daily
16207646|NCT01334879|Drug|ranibizumab 2.0 mg|Intravitreal ranibizumab (2.0 mg)
16207647|NCT01334866|Procedure|Minimally invasive coronary artery bypass graft surgery|The MICS CABG procedure can bridge the gap between percutaneous coronary intervention (PCI) and standard sternotomy. The key components are direct vision, creating anastomoses with traditional instruments and proximal aortic location.
16207648|NCT01334853|Other|No drug will be used|Biomarker
16207649|NCT01334853|Other|No drug will be used|Biomarker
16207650|NCT01334840|Dietary Supplement|Bicarbonated mineral water|"Volunteers fasted overnight consumed:
~0.5 L of the bicarbonated mineral water without meal or, 0.5 L of the bicarbonated mineral water with meal"
16207651|NCT01334840|Dietary Supplement|Mineral water low in mineral content (control)|"Volunteers fasted overnight consumed:
~0.5 L of the control water without meal or, 0.5 L of the control water with meal"
16207652|NCT01334827|Other|high volume gel|4 mL HEC
16207653|NCT01334827|Other|low volume gel|2 mL HEC
16207654|NCT01334827|Other|vaginal film|"1 x 2 intravaginal quick-dissolving film"
16207655|NCT01334814|Device|Deep Brain Stimulation (Model 7438 Therapy Controller)|Deep brain stimulation (DBS) is a surgical procedure used to treat a variety of disabling neurological symptoms
16207656|NCT01334801|Procedure|Blood Draw|"Two tubes of blood (about five tablespoons) will be drawn for research purposes, and these will be analyzed for the following tests:
~BNP (Brain Natriuretic Peptide)
~(PFA) Platelet Function Analyzer 100
~von Willebrand Factor (vWF) antigen
~(vWF) multimers
~(vWF) *activity by latex aggregation
~Plasma stored for development of new testing approaches"
16207657|NCT01334788|Other|sleep deprivation|Sleep restriction
16207658|NCT01334788|Other|Normal sleep|These are subjects who are randomized to sleep normally.
16207659|NCT01334775|Procedure|Open anterior inguinal hernia repair|Placement of a surgical mesh in open anterior inguinal hernia repair.
16207660|NCT01334762|Drug|Letrozole/IUI|Patients received 5 mg letrozole daily for 5 days. A single insemination was performed 32-36 hours after hCG (10,000 IU, IM). Patients underwent up to four cycles of treatment.
16207661|NCT01334762|Drug|CC/IUI|Patients received 100 mg lCC daily for 5 days. A single insemination was performed 32-36 hours after hCG (10,000 IU, IM). Patients underwent up to four cycles of treatment.
16207662|NCT01334736|Behavioral|Usual care|After participants have completed the data collection portion of the SHIELD visit, the research assistant will provide the participant with an informational flyer regarding the risks of tobacco smoking and benefits of tobacco cessation. The participant will be provided the phone number for the Tobacco Quit Line in Maryland as well as a list of local tobacco cessation programs. Any questions will be answered by the research assistant. If the participant inquires about nicotine replacement therapy, they will be advised to contact their primary care provider to discuss potential therapeutic options. Spirometry results will be verbally disclosed to participants describing their lung function as a percent of predicted value. A handout with these results will be given to participants. At each follow-up visit, after obtaining CO and questionnaire data, spirometry results will be reviewed and participants will be offered the informational flyer and quit line number.
16207663|NCT01334736|Behavioral|Lung age|For individuals randomized to spirometric lung age intervention, after completion of data collection, CO level and acceptable spirometry, the participant will be verbally informed of spirometric results. It will be explained that lung function normally reduces with age and that smoking can damage lung as if they were aging more rapidly than normal using visual depictions. Their lung function estimates based on their chronological age and lung age will be provided. They will be informed that smoking cessation would slow the aging of their lungs. After questions are answered, the participant will receive a written report that includes enumeration of their lung age and chronological age. At initial and follow-up visits, the research assistant will provide the participant with the same informational flyer and Tobacco Quit Line in Maryland as the usual care intervention.
16207684|NCT01334567|Drug|Tenofovir DF|Provision of tenofovir disoproxil fumarate (tenofovir DF) 300 mg tablets, as prescribed by study investigators
16207685|NCT01334554|Drug|Sildenafil|20 mg three times a day.
16207686|NCT01334554|Drug|Placebo|No active drug
16207762|NCT01333943|Procedure|Control Group|The control group will receive the femoral nerve block. The block will be under ultrasound guidance. The local anesthetic will be 30 ml of 0.25% bupivicaine. The control group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg).
16208047|NCT01332058|Behavioral|Motivational Interviewing|8 possible weeks of motivational interviewing sessions
16207664|NCT01334736|Behavioral|Contingency Management|For individuals randomized to CM, after completion of data collection, it will be explained to the participant that they will receive monetary compensation for biological confirmation of tobacco cessation. At each visit, exhaled carbon monoxide levels will be checked. If the subject has a negative CO level, they will be compensated. If a participant has a CO consistent with recent tobacco use, (s)he will receive the payment for attending the visit, but no additional payment at that visit. Spirometry results will be verbally disclosed to participants describing their lung function as a percent of predicted value. A handout with these results will be given to participants. At each follow-up visit, after obtaining CO and questionnaire data, spirometry results will be reviewed and participants will be offered the informational flyer and quit line number.
16207665|NCT01334736|Behavioral|Lung age + Contingency Management|For individuals randomized to the combined contingency management + spirometric lung age intervention, after completion of data collection, CO level and acceptable spirometry, the participant will be described the process of contingency management as outlined above. Following this, the research assistant will then describe lung age to the participant as described above. At the end of this process, the participant will then receive the informational flyer, quit line and local tobacco cessation program information similar to the usual care intervention. At each follow-up visit, after obtaining CO level and questionnaire outcomes, appropriate CM payment, review of participant's baseline lung age and informational flyer will occur.
16207666|NCT01334723|Drug|Adherent with 5-alpha-reductase inhibitor (5ARI) therapy|Patient with BPH who are adherent to 5ARI therapy (Adherence will be calculated using a medication possession ratio (MPR); 3 MPR threshold values of 70%, 75%, and 80% will be evaluated.)
16207667|NCT01334723|Drug|Non-adherent to 5ARI therapy|Patients with BPH non-adherent to 5ARI therapy (Adherence will be calculated using a MPR; 3 MPR threshold values of 70%, 75%, and 80% will be evaluated.)
16207668|NCT01334710|Drug|Sorafenib and OSI-906|Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily
16207669|NCT01334697|Drug|recombinant human cardiotrophin-1|Single dose intravenous administration
16207670|NCT01334697|Other|Placebo|Single dose intravenous administration
16207671|NCT01334684|Drug|Metformin|Metformin, pills, 850 mg three times a day for three months
16207672|NCT01334671|Drug|Atorvastatin|Group 1:80mg before PCI and 40mg per day after PCI for one month then 20mg per day until the end of the trial Group 2:40mg per day after PCI for one month then 20mg per day until the end of the trial Group 3:20mg per day after PCI until the end of the trial
16207673|NCT01334658|Procedure|Phacoemulsification cataract surgery|"A group received BSS ® (ALCON LABORATORIES, INC.) and another group received glucose-bicarbonate-Ringer Lactate (GBRL) [500 cc. Ringer Lactate (GLICOLABOR, Pharmaceutical LTD.) enriched with 1.5 ml of glucose in water (25%) and 08 ml of sodium bicarbonate (8.4%)] as a solution for irrigation during surgery.
~All surgeries were performed by single surgeon (HON), using the standard surgical technique quick-chop. Immediately before surgery, solutions for irrigation [BSS ® (ALCON LABORATORIES, INC..) and glucose-bicarbonate-Ringer Lactate (GBRL)] were brought to the operating table in a temperature of 22 degrees Celsius. The microcoaxial Phacoemulsification was performed under a phaco Legacy Series 20000 (ALCON LABORATORIES, INC..)."
16207674|NCT01334658|Drug|Glucose-bicarbonate-Ringer Lactate (GBRL)|"A group received BSS ® (ALCON LABORATORIES, INC.) and another group received glucose-bicarbonate-Ringer Lactate (GBRL) [500 cc. Ringer Lactate (GLICOLABOR, Pharmaceutical LTD.) enriched with 1.5 ml of glucose in water (25%) and 08 ml of sodium bicarbonate (8.4%)] as a solution for irrigation during surgery.
~All surgeries were performed by single surgeon (HON), using the standard surgical technique quick-chop. Immediately before surgery, solutions for irrigation [BSS ® (ALCON LABORATORIES, INC..) and glucose-bicarbonate-Ringer Lactate (GBRL)] were brought to the operating table in a temperature of 22 degrees Celsius. The microcoaxial Phacoemulsification was performed under a phaco Legacy Series 20000 (ALCON LABORATORIES, INC..)."
16207675|NCT01334658|Drug|Balanced Salt Solution (BSS®)|"A group received BSS ® (ALCON LABORATORIES, INC.) and another group received glucose-bicarbonate-Ringer Lactate (GBRL) [500 cc. Ringer Lactate (GLICOLABOR, Pharmaceutical LTD.) enriched with 1.5 ml of glucose in water (25%) and 08 ml of sodium bicarbonate (8.4%)] as a solution for irrigation during surgery.
~All surgeries were performed by single surgeon (HON), using the standard surgical technique quick-chop. Immediately before surgery, solutions for irrigation [BSS ® (ALCON LABORATORIES, INC..) and glucose-bicarbonate-Ringer Lactate (GBRL)] were brought to the operating table in a temperature of 22 degrees Celsius. The microcoaxial Phacoemulsification was performed under a phaco Legacy Series 20000 (ALCON LABORATORIES, INC..)."
16207676|NCT01334645|Other|Copeptin|"Patients with hyponatremia < 135 mmol/L or troponin > 1 μg/L are released study.
~Blood sampling are taken for Troponine T, myoglobin, creatin kinase and copeptine analysis and 18-lead ECG was performed after 2, 4, 6 and 12 h.
~Copeptin and myoglobin are measured at the end of the patients inclusion, after to be centrifugrd end frozen at -80°C at each time point.
~The treatment of patients is not modified by the study. At 90 days, clinicals and paraclinicals events are collected"
16207677|NCT01334632|Procedure|Continuous interscalene block|The continuous interscalene block will be performed with ultrasound 30 minutes before the intervention.
16207678|NCT01334632|Procedure|PCA morphine|Postoperative with iv self-administration of morphine
16207679|NCT01334619|Procedure|appropriate volume of 0.5% ropivacaine|initial concentration: 30 ml, subsequently varied at a ratio of 1: 1.2 for each consecutive patient according to the response of the previous patient, until 5 up-and-down cycles completed.
16207680|NCT01334606|Device|4 mm x 32G pen needle (Nano)|The pen needle will be used to administer all pen-based diabetes medications. When using the 4mm Nano pen needle, subjects are directed to hold the pen device at a 90 degree angle and perform the injection with no pinch-up.
16207681|NCT01334606|Device|8mm x 31G pen needle (Short)|The pen needle will be used to administer all pen-based diabetes medications. When using the 8mm Short pen needle, subjects are directed to use the pinch-up technique for injections in the abdomen and thigh, and no pinch-up at other injection sites. Subjects are to hold the pen device at a 90 degree angle.
16207682|NCT01334580|Behavioral|Cognitive-Behavioral Therapy for Pain and Opioid Dependence|CBT is provided by skilled psychologists in weekly sessions for 12 weeks and focuses on reducing illicit drug use and increasing pain management.
16207683|NCT01334580|Behavioral|Methadone Drug Counseling|Methadone Drug Counseling (MDC)is provided by skilled drug counselors over a 12-week period. The primary goal of MDC is cessation of illicit drugs.
16208291|NCT01329913|Drug|Placebo to MK-6325|Eight 100 mg capsules, orally, once per day for 7 days
16207687|NCT01334541|Behavioral|SAFE VET|"All SAFE VET EDs provide a standardized intervention that is specifically adapted for use in the ED to mitigate suicide risk. Given that the SAFE VET intervention was developed for use in a busy ED setting, the length of the intervention is approximately 45 minutes. The SAFE VET intervention is administered by a clinical provider who has been specifically trained and consists of:
~Risk Assessment
~Safety Planning Intervention: Developed by Stanley and Brown (2008), Safety Planning Intervention consists of a hierarchically-arranged list of coping strategies identified for use during a subsequent suicidal crisis.
~Clinical Follow-Up Protocol"
16207688|NCT01334515|Biological|hu14.18-IL2 fusion protein|Given IV
16207689|NCT01334515|Drug|isotretinoin|Given PO
16207690|NCT01334515|Biological|sargramostim|Given SC
16207691|NCT01334515|Other|laboratory biomarker analysis|Correlative studies
16207692|NCT01334502|Biological|rituximab|PO
16207693|NCT01334502|Drug|cyclophosphamide|IV
16207694|NCT01334502|Drug|doxorubicin hydrochloride|IV
16207695|NCT01334502|Drug|everolimus|PO
16207696|NCT01334502|Drug|prednisone|PO
16207697|NCT01334502|Drug|vincristine sulfate|IV
16207698|NCT01334489|Device|Arabin Cervical Pessary|"The Arabin cervical pessary, which is CE-certified for preventing SPB (CE 0482 / EN ISO 13485: 2003 annex III of the council directive 93/42 EEC).
~It is a vaginal device which is used to treat pregnant women for preventing spontaneous preterm birth. This device can be easily placed around the uterine cervix without pain."
16207699|NCT01334450|Device|TMS , H2-coil|Trans cranial magnetic stimulation with H2-coil
16207700|NCT01334424|Drug|propofol|2-2.5 mg/kg for induction plus or not plus 2 mg/kg.h for maintenance
16207701|NCT01334398|Behavioral|Health & Wellness|"The specific content of the intervention was adapted from four existing evidence-based interventions: (1) Healthy Lifestyles for People with Disabilities, (2) Promoting Wellness for Women with MS, (3) Living Well with Disability, and (4) Social Skills and TBI: A Workbook for Group Treatment."
16207702|NCT01334372|Behavioral|CAMS|First, as discussed above, suicidality is the focus of treatment rather than one of many symptoms being treated. Second is the emphasis on patient and therapist collaborating on treatment rather than the therapist dictating how therapy progresses. Beyond those two basic tenets, each therapist is free to utilize their current clinical skills to conduct psychotherapy.
16207703|NCT01334359|Behavioral|Physical Activity|9-month afterschool program designed to increase physical activity and aerobic fitness.
16207704|NCT01334346|Other|Nike Pegasus|Conventional neutral supportive running footwear. Non minimalist.
16207705|NCT01334346|Other|Nike Free 3.0|Partial minimalist shoe with partially elevated heel, but with increased mid-sole flexibility.
16207706|NCT01334346|Other|Vibram Five Fingers Shoe|Full minimalist shoe. Virtually no mid-sole, therefore no heel elevation or forefoot rockering. A proxy for a barefoot running condition.
16207707|NCT01334333|Drug|Tacrolimus - Prograf® twice daily formulation|twice daily, dosage will be as determined by best treatment for each participant, duration of study period will be 4 months for each participant
16207708|NCT01334333|Drug|Tacrolimus - Advagraf® once daily formulation|once daily, dosage will be as determined by best treatment for each participant, duration of study period will be 4 months for each participant
16207709|NCT01334320|Procedure|elective neck dissection|patient underwent elective neck dissection as initial treatment, along with the excision of the primary tumor
16207710|NCT01334307|Device|Lung Volume Reduction Coil (LVRC) (PneumRx)|Lung Volume Reduction Coil (LVRC)
16207711|NCT01334307|Device|Control|Standard of Care
16207712|NCT01334294|Device|ForeseeHome|The ForeseeHomeTM device, was designed to identify central and paracentral irregularities (vision abnormalities) in the visual field, most commonly associated with exudative macular degeneration.
16207713|NCT01334281|Procedure|Blood Draw|Three tubes of blood will be drawn (three 10ml-green top), 7 times (total of 210 ml for study) at the indicated time points: 1) enrollment, 2) anticipated midpoint of desensitization, 3) prior to transplant, 4) three months post-transplant, 5) six months post-transplant, 6) 12 months post-transplant, and 7) 24 months post-transplant.
16207714|NCT01334281|Procedure|Blood Draw|Three tubes of blood will be drawn (three 10ml-green top) twice (60 ml total for study), 8-12 weeks apart. Can be drawn during clinic visit or separate standard of care dialysis visit.
16207715|NCT01334268|Device|Taxus Liberte Paclitaxel-Eluting Coronary Stent System|Taxus Liberte Paclitaxel-Eluting Coronary Stent System Implantation
16207716|NCT01334268|Device|Resolute Zotarolimus-Eluting Coronary Stent System|Resolute Zotarolimus-Eluting Coronary Stent System Implantation
16207717|NCT01334255|Drug|iSONEP (sonepcizumab/LT1009)|Up to 3 doses of iSONEP given monthly will be administered as intravitreous injections in the ophthalmologist's office.
16207718|NCT01334242|Drug|Schedule A|Dosing 1 hour before breakfast
16207719|NCT01334242|Drug|Schedule B|Dosing 0.5 hour before breakfast
16207720|NCT01334242|Drug|Schedule C|Dosing immediately before breakfast
16207721|NCT01334242|Drug|Schedule D|Dosing immediately before lunch
16207722|NCT01334242|Drug|Schedule E|Split dose, dosing 1 hour before breakfast and dinner
16207723|NCT01334229|Drug|Sitagliptin|Sitagliptin 100 mg/d for 6 weeks
16207724|NCT01334229|Drug|Placebo|Placebo for 6 weeks
16207725|NCT01334216|Other|CHICA Smoking Cessation Module|The CHICA module helped to screen parents for smoking and assist them in quitting.
16207726|NCT01334216|Other|CHICA Placebo|This was CHICA without the study module.
16207727|NCT01334203|Drug|Ranolazine|"Subjects will be randomized to either ranolazine 500 mg twice daily up-titrated on Day 4 to 1000 mg administered orally twice a day or matching placebo for the 12 week treatment period.
~Subjects receiving diltiazem or verapamil as their concomitant antianginal medication will receive ranolazine 500 mg or placebo administered orally twice a day."
16207728|NCT01334177|Drug|TLR8 agonist VTX-2337|Given SC
16207729|NCT01334177|Biological|cetuximab|Given IV
16207730|NCT01334177|Other|laboratory biomarker analysis|Correlative studies
16207731|NCT01334177|Other|pharmacogenomic studies|Correlative studies
16207763|NCT01333930|Other|Active O2|oxygenised table water containing at least 20 mg O2 per 500 ml (15-fold higher content in comparison to placebo), further excipients: natural mineral water: carbonic acid, oxygen, sodium, potassium, magnesium, calcium, fluoride, chloride, nitrate, sulfate, hydrocarbonate (according to the summary of analysis)
16207732|NCT01334164|Behavioral|Recovery Management Checkups|Women assigned to the RMC condition met with a linkage manager after each research interview. When a woman reported substance use, HIV risk behavior or illegal activity, the linkage manager used motivational interviewing to: provide feedback regarding her current substance use, HIV risk behavior or illegal activity, discuss barriers that prevented her from stopping each activity and ways of avoiding them in the future, and assess and discuss her level of motivation for change. Linkage managers also scheduled treatment appointments, accompanied the women to treatment intake and stayed through the process and implemented an Engagement and Retention Protocol designed to improve retention rates. For women who refused the treatment option, the linkage manager and participant agreed upon an Alternative Action plan, which included various behaviors the woman had agreed to engage in to reduce or stop her substance use, HIV risk, or her participation in illegal activity.
16207733|NCT01334164|Other|Outcome Monitoring|Outcome monitoring only, however participates are still able (and do) enter treatment on their own
16207734|NCT01334151|Drug|Insulin LISPRO|Single doses of: 0.15 U/kg
16207735|NCT01334151|Drug|recombinant human insulin|Single doses of: 0.15 U/kg
16207736|NCT01334138|Other|A 4-week diet, low in sodium.|"Study subjects receive personal advice to decrease sodium consumption and will change his diet for 28 days.
~Follow up is performed by measuring blood pressure, a 24-hour urine sample collection, diaries and questionnaires."
16207737|NCT01334125|Drug|Metformin|Metformin 1000 mg once daily by mouth for 9 months
16207738|NCT01334125|Drug|Placebo|2 capsules once daily by mouth for 9 months
16207739|NCT01334112|Drug|Axitinib (AG-013736)|5mg, oral, twice daily, continuous dosing. A dosing cycle is defined as 4 weeks. Treatment may continue until disease progression/relapse
16207740|NCT01334099|Biological|CP-675,206|Intravenous infusion for one cycle (further cycles permitted as per medical assessment). Patient assigned dose of 3mg/kg, 6mg/kg, 10mg/kg, or 15mg/kg.
16207741|NCT01334099|Radiation|External local radiation therapy|One cycle of 2000cGy administered locally to one site over 5 days.
16207742|NCT01334086|Drug|Aprepitant|Oral aprepitant will be given to the participant on Days 1-5 of standard induction treatment. A dose of 125 mg will be given on Day 1 and 80 mg will be given on Days 2-5.
16207743|NCT01334073|Drug|Axitinib plus everolimus|Patients will take both drugs orally, every day, without planned rest period (AX bid and EV once a day). By convention one cycle is 28 days. At the first cycle patients will take one week of AX single agent before starting EV. Patients will be treated at increasing dose levels (DLs) in successive cohorts of 3-6 patients according to the number of patients with dose limiting toxicities (DLT) until the maximum tolerated dose
16207744|NCT01334060|Biological|p.DOM-WT1-37 DNA Vaccine and p.DOM-WT1-126 DNA Vaccine|p.DOM-WT1-37: 1mg/dose/vaccine p.DOM-WT1-126: 1mg/dose/vaccine The DNA vaccine will be administered 6 times at 4 weekly intervals. Responders (Immunological but without molecular progression) may continue vaccination 3 monthly to maximum of 24 months. The vaccines will be injected intramuscularly (im) followed by electroporation (EP) into separate locations.
16207745|NCT01334047|Biological|DC-006 vaccine|Vaccine is administered every 4 weeks during the first year. Only patients that show immunological response will continue vaccination every months during the 2nd and 3rd year.
16207746|NCT01334034|Drug|NNC 0123-0000-0338|Subjects will be randomised to receive a single dose of NNC 0123-0000-0338 (tablet), at 7 escalating dose levels. Progression to next dose level will be based on a safety evaluation.
16207747|NCT01334034|Drug|placebo|Subjects will receive a single dose of placebo (tablet), as a comparator to NNC 0123-0000-0338 at all dose levels. Placebo dose remains the same at all dose levels.
16207748|NCT01334034|Drug|insulin glargine|As an open label active comparator, a single dose of insulin glargine will be administered subcutaneously (under the skin), at all dose levels. Insulin glargine dose remains the same at all dose levels.
16207749|NCT01334021|Procedure|Biopsy|Undergo tumor biopsy
16207750|NCT01334021|Procedure|Conventional Surgery|Undergo surgery
16207751|NCT01334021|Other|Genetic Testing|Undergo genetic testing
16207752|NCT01334008|Biological|Blood sampling|30ml of patient peripherical blood will be collected
16207753|NCT01333995|Behavioral|Peer counseling on infant feeding|Peer counseling intervention group will recieve nutrition education on initiation of breastfeeding within one hour of delivery, continuation of exclusive breastfeeding until six months, and timely introduction of safe, nutritionally adequate complementary feeding after six months.
16207754|NCT01333982|Other|Amoxycillin, Gentamicin|If referral fails, community management of neonatal sepsis according to clinical algorithm.
16207755|NCT01333982|Other|Counselling|counselling of management of neonatal sepsis in the community according to clinical algorithm.
16207756|NCT01333969|Procedure|Ischemic Preconditioning|In the study group, the patients' operative limb will be preconditioned by inflating the tourniquet for 5 minutes, followed by deflation and a 5-minute reperfusion period. Subsequently, the tourniquet will be inflated for the entire length of the operation (before skin incision to after insertion of the final components). In the control group, the tourniquet will be used for the entire length of the operation without a preconditioning phase.
16207757|NCT01333956|Drug|Pregabalin 50mg|Patients will receive 50mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
16207758|NCT01333956|Drug|Pregabalin 100mg|Patients will receive 100mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
16207759|NCT01333956|Drug|Pregabalin 150mg|Patients will receive 150mg of pregabalin per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
16207760|NCT01333956|Drug|Placebo|Patients will receive placebo drug with no active ingredients per dose. 2 capsules will be taken pre-operatively. One capsule twice a day until end of POD14 and one capsule at bedtime POD15, POD16.
16207761|NCT01333943|Procedure|Study Group: Experimental|The study group will receive the saphenous nerve block, at the level of the adductor canal. The block will be under ultrasound guidance. The local anesthetic will be 15 ml of 0.5% bupivicaine. The study group will also receive a combined spinal epidural, with 2.5 ml of 0.5% bupivacaine as the spinal agent. Additional drugs include anti-emetics, specifically Ondansetron (4 mg).
16207991|NCT01332370|Drug|Rosiglitazone + Metformin|At least 180 days of continuous therapy with RSG+MET after the first Rx for RSG
16207764|NCT01333930|Other|Adelholzener Mineralwasser|natural mineral water containing the following ingredients: carbonic acid, sodium, potassium, magnesium, calcium, fluoride, chloride, nitrate, sulphate, hydrocarbonate (according to the summary of analysis)
16207765|NCT01333917|Drug|Curcumin C3 tablet|4 grams Curcumin C3 tablet daily x30 days
16207766|NCT01333904|Drug|PUR118|inhaled
16207767|NCT01333891|Drug|Phenylephrine|Neosynephrine®, Winthrop Breon Laboratories New York, NY, USA 0, 0.5, 1 and 2 μg/kg/min, each infusion step for 5 minutes, total infusion period of 20 minutes
16207768|NCT01333891|Drug|Sodium-Nitroprusside|Nipruss®, Sanol-Schwarz, Monheim, Germany 0, 0.5, 1 and 2 µg/kg/min, each infusion step for 5 minutes, total infusion period of 20 minutes
16207769|NCT01333891|Device|Suction Cup|experimental stepwise increase of intraocular pressure while measurement of choroidal thickness suction force of 25, 50, 75, and 100 mmH
16207770|NCT01333891|Device|Goldmann applanation tonometer|intraocular pressure measurements
16207771|NCT01333891|Device|1060nm Optical coherence tomography|Optical coherence tomography is a widely used non-invasive method to image the retina and choroid. Using a 1060nm light source coupled to a commercially available OCT system (Heidelberg Engineering, Heidelberg, Germany) allows for the measurement of choroidal thickness
16207772|NCT01333878|Biological|Subcutaneous Abatacept|Subcutaneous Abatacept 125 mg once weekly for 6 months
16207773|NCT01333865|Drug|Memantine|"Memantine (Namenda®) was approved by the U.S. Food and Drug Administration in 2003 and by the European Agency for the Evaluation of Medical Products in 2002 for the treatment of moderate to severe Alzheimer's disease. Evidence from available treatment trials of memantine in ASD and non-ASD populations of youth and adults strongly suggest that memantine could be an effective agent for the treatment of adults with ASD.
~During the 12 weeks of study duration, subjects will be evaluated at weekly intervals for the first 4 weeks and thereafter every 3 weeks. Memantine will be administered in divided dose twice a day in the morning and evening. Titration of study medication will be guided by a forced titration schedule with an option for slower titration or holding at lower dose per clinician judgment. Safety, effectiveness, response and side effects will be evaluated."
16207774|NCT01333852|Drug|metformin up to 2500mg/d|metformin up to 2500mg/d
16207775|NCT01333852|Drug|paclitaxel 175mg/m² q21d|paclitaxel 175mg/m² q21d
16207776|NCT01333852|Drug|placebo|placebo
16207777|NCT01333839|Other|exercise training|endurance exercise training: 40 min of exercise at 65% of VO2peak, 3 days/week
16207778|NCT01333826|Behavioral|Zomba Cash Transfer Program|Cash transfers were provided monthly to a randomly selected sample of school aged girls. Amounts were also varied in both treatment arms.
16207779|NCT01333813|Biological|Engerix-B™ Kinder|Intramuscular, single dose
16207780|NCT01333800|Drug|Beclomethasone|200 to 400 mcg per day for 6 months
16207781|NCT01333800|Drug|Ciclesonide|80 to 160 mcg per day for 6 months
16207782|NCT01333787|Dietary Supplement|Dietary Fiber Mixture|"During the four weeks the patients received fiber mixtures (intervention) or maltodextrine as the placebo. The fiber mixture was composed of six different types of fibers: 10.5% fructooligosaccharides, 12.5% inulin, 24% Arabic gum, 9% resistant starch, 33% Soya polysaccharide e 12% cellulose.
~The dose was defined in accordance with the child's body weight: 6.3 grams of fiber supplement, which corresponds to 4.8 g of fiber, or placebo(1 table spoon) twice per day, diluted in 200 mL of a milky chocolate drink for children weighing up to 18 kg; 12.6 grams of fiber supplement, which corresponds to 9.6 g of fiber, or placebo (2 table spoons) twice per day, diluted in 200 mL of a milky chocolate drink for children weighing more than 18 Kg."
16207783|NCT01333774|Drug|Glucobay (Acarbose, BAYG5421)|Patients treated with acarbose tablets under the real-life setting. Dosing regimen customised to the needs of each participating patient according to the investigators assessment
16207784|NCT01333761|Device|Cardiox FDS|The Cardiox Shunt Detection system consists of a sensor placed in contact with the outer ear, similar to a finger probe used to detect oxygen levels in blood. Through an intravenous line, ICG (indocyanine green) at a dosage of 10 mg (2 mL of 5 mg/mL ICG solution) per test, is administered into the right or left antecubital fossa. The presence of ICG in the veins within the outer ear are detected, and the results are displayed on a monitor. All patients will also be evaluated with TCD and TEE for the presence of RTLS.
16207785|NCT01333748|Genetic|blood collection|blood collection for research quantification of allelic expression in the gene BRCA1.
16207786|NCT01333748|Genetic|blood collection|blood collection for research quantification of allelic expression in the gene BRCA1.
16207787|NCT01333722|Drug|Hydrocodone/Acetaminophen Extended Release|
16207788|NCT01333722|Drug|Placebo|Placebo tablet
16207789|NCT01333709|Drug|Induction trichemotherapy - FOLFIRINOX regimen|A short (4 cycles) and intensive trichemotherapy combinig irinotecan 180 mg/m2, oxaliplatin 85 mg/m2, elvorin 200 mg/m2, 5-Fu (bolus 400 mg/m2, followed by a 46-hour continuous infusion 2,400 mg/m2) will be delivered for 8 weeks (D1=D15).
16207790|NCT01333709|Other|Early tumor response evaluation by MRI volumetry|Two weeks after the CT completion, the tumor volume will be measured by MRI with specific software which automatically borders the tumor so as to determine the early tumor response. A centralized reassessment of all MRI exams will be systematically performed by two radiologists of the coordinator center.
16207791|NCT01333709|Radiation|Radiochemotherapy Cap 50|RCT Cap 50 will combine radiotherapy at a dose of 50 Gy by either conventional 3D or IMRT (2 Gy per fraction, 5 fractions per week during 5 weeks / 44 Gy in mini pelvis, and boost 6 Gy on reduced peritumoral volume) with concomitant oral capecitabine at 1600 mg/m2 per day delivered the days of RT treatment (2 daily intake).
16207792|NCT01333709|Radiation|Radiochemotherapy Cap 60|RCT Cap 60 will combine radiotherapy at a dose of 60 Gy by either conventional 3D or IMRT (2 Gy per fraction, 5 fractions per week during 6 weeks / 44 Gy in mini pelvis, and boost 16 Gy on reduced peritumoral volume) with concomitant oral capecitabine at 1600 mg/m2 per day delivered the days of RT treatment (2 daily intake)
16207793|NCT01333709|Procedure|Radical proctectomy with total mesorectal excision|The proctectomy can be performed by laparoscopic surgery or conventional laparotomy.
16207794|NCT01333696|Drug|Pemetrexed|Pemetrexed 500 mg/m2 at day 1. Frequence of cycles: every 3 weeks
16207795|NCT01333670|Device|Prontosan wound irrigation solution|"cleansing wound bed at change with Prontosan Wound Irrigation solution (syringe 20-30 ml, needle 19-20 G)
~positioning of sterile gauze dressing impregnated with Prontosan Wound Irrigation solution on the wound for 10 minutes
~dressing with Prontosan Wound Irrigation solution"
16207796|NCT01333670|Drug|Isotonic solution (saline or lactated ringer)|"cleansing wound bed at change with isotonic solution (syringe 20-30 ml, needle 19-20 G)
~positioning of sterile gauze dressing impregnated with isotonic solution on the wound for 10 minutes
~dressing with isotonic solution"
16207797|NCT01333631|Drug|Valproic acid|Valproic acid given concurrent with chemoradiotherapy for patients with pancreatic cancer
16207798|NCT01333618|Device|curving introducer Günther Tulip Filter|The Günther Tulip filter (Vena Cava MReye Filter Set; William Cook Europe, Bjaeverskov, Denmark) The amplitude of introducer curvature was 5°-15° less than the angle between the inferior vena cave axis and the approached iliac vein axis and the distance between the vertex of the curved angle and the hook of the filter was 2-4cm less than the distance between the level of the renal vein confluence and the furcation of inferior vena cave.
16207799|NCT01333618|Device|straight introducer Günther Tulip Filter|The Günther Tulip filter (Vena Cava MReye Filter Set; William Cook Europe, Bjaeverskov, Denmark)
16207800|NCT01333605|Drug|IGEV|Ifosfamide 1200 mg/m2 at days 1-4, Mesna 400 mg 0,4,8h at days 1-4, Gemcitabine 800 mg/m2 at day 1 and day 4, Vinorelbine 20 mg/m2 at day 1, Prednisone 100 mg at days 1-4. Frequency of cycles: every 3 weeks. Numbers of cycles: 4 cycles.
16207801|NCT01333592|Drug|KAD-1229|
16207802|NCT01333579|Other|Repetitive transcranial magnetic stimulation|Repetitive transcranial magnetic stimulation, frequency of 1Hz, once a day for ten days.
16207803|NCT01333566|Behavioral|Intervention Group|The study will include one week baseline phase, 6-week intervention phase, and a 3-month follow-up evaluation. Subjects in the intervention group will go through three training sessions during the baseline phase, weekly group exercise sessions once per week and daily home exercises two times each day during the intervention phase, and a follow-up evaluation in three months after the intervention phase.
16207804|NCT01333566|Behavioral|Placebo Comparator: Control Group|Subjects in the control group will be monitored during the baseline and intervention phase without participating in the interventional exercise. At the end of intervention phase, the subjects will have the option to stop their participation or switch to the intervention group.
16207805|NCT01333553|Device|Image-guided remove Port Wine Stain|Image-guided surgery remove Port Wine Stain
16207806|NCT01333540|Drug|TD-1211|Escalating doses
16207807|NCT01333540|Drug|Placebo|Placebo once daily
16207808|NCT01333527|Procedure|No Sling|Early range of motion
16207809|NCT01333527|Procedure|Sling|Patients will use the sling for 6 weeks, as per usual care
16207810|NCT01333514|Drug|aspart|Subjects will received aspart insulin subcutaneously based on the amount of carbohydrates consumed based on the formula 0.1 units/kg X (grams of carbohydrate eaten/75 grams carbohydrate)
16207811|NCT01333514|Drug|aspart|0.1 units/kg of Aspart insulin will be given subcutaneously TID with meals if a subject eats 50% or more of their meal-tray
16207812|NCT01333501|Drug|Fingolimod|0.5 mg in capsules for oral administration once daily
16207813|NCT01333501|Drug|Interferon beta 1b|250 μg injected s.c. every other day
16207814|NCT01333488|Device|Arctic Sun|Core Body Temperature will be lowered using an Arctic Sun device to 34C. Bladder probe will monitor core temperature.
16207815|NCT01333488|Drug|Magnesium Sulfate|IVI drug levels of Magnesium Sulfate targeted to plasma levels of magnesium of 2.5-3.5 mEq/Liter.(1.25-1.75mmol/L; or 3.04 - 4.26mg/dL)for 72 hours.
16207816|NCT01333475|Drug|MK-2206 + AZD6244|MK-2206 and AZD6244 hydrogen sulfate are selective inhibitors of human AKT and MEK, respectively, with preclinical and clinical anti-tumor activity as single agents and in combination with a variety of drugs. Combination treatment in mouse cancer models harboring mutations in both the PI3K and RAS pathways was more potent compared to either agent used alone, and resulted in substantial tumor inhibition, including tumor regression.
16207817|NCT01333462|Biological|NB-1008|NB-1008 is composed of Fluzone containing 4 micrograms (mcg) or 10 micrograms of strain-specific hemagglutinin (HA) and 5%, 10%, 15%, or 20% W805EC adjuvant.
16207818|NCT01333462|Other|Control|The controls include PBS placebo control as well as Fluzone IN and IM active controls.
16207819|NCT01333449|Drug|Decitabine|20mg/m^2 infusion one hour per day, for 5days,every 28days,total 2-6cycles.
16207820|NCT01333436|Other|Test Meal|During Visit 2, a test meal will be supplied by the Sponsor of approximately 944 kcal (57% fat, 31% carbohydrate, and 12% protein), and postprandial blood draws will be done at 1, 2, 3, 4, and 6 hours after the meal.
16207821|NCT01333423|Drug|Liposomal Doxorubicin|40 mg by vein administered over 2 -3 hours on Day 4 of a 28 day cycle.
16207822|NCT01333423|Drug|Seliciclib|Starting dose 200 mg by mouth twice daily on Days 1 - 3 of a 28 day cycle.
16207823|NCT01333410|Drug|tacrolimus ointment|2 applications per days for 6 months
16207824|NCT01333410|Drug|Mometasone furoate|2 applications per day for 6 months
16207825|NCT01333397|Biological|Botulinum toxin type A|I.M. (in the muscle) injection on day 1 (single treatment cycle)
16207826|NCT01333397|Biological|Botulinum toxin type A|I.M. on day 1 (single treatment cycle)
16207827|NCT01333397|Drug|Placebo|I.M. on day 1 (single treatment cycle)
16207828|NCT01333371|Procedure|Surgical Repair of Distal Radius Fracture|2 surgical methods to treat Distal Radius Fracture
16207829|NCT01333358|Drug|Alemtuzumab|Alemtuzumab 12mg given intravenously each day for five days and again twelve months later for an additional three days
16207830|NCT01333332|Drug|Capecitabine|Capecitabine
16207831|NCT01333332|Radiation|Standard Dose Acclerated Fraction Radiotherapy|Standard dose accelerated fraction radiotherapy
16207832|NCT01333306|Procedure|Transcranial direct current stimulation (tDCS)|
16207833|NCT01333293|Drug|injections|subcutaneous injections
16207834|NCT01333280|Behavioral|Double Trouble in Recovery|DTR is a 12 Step-based fellowship for individuals with co-occurring problems of substance abuse and mental illness
16207835|NCT01333280|Behavioral|Treatment as usual|Receive usual treatment at the programs
16207836|NCT01333267|Drug|Parathyroid Hormone-related Protein (1-36)|PTHrP (1-36) intravenously at 2 picomoles (pmols)/kg/hr for one week; doses will be increased by 2 picomoles (pmols)/kg/hr in subsequent subjects.
16207837|NCT01333267|Drug|parathyroid hormone (1-34)|PTH (1-34) intravenously at 2 picomoles (pmols)/kg/hr for one week; doses will be increased by 2 picomoles (pmols)/kg/hr in subsequent subjects.
16207992|NCT01332370|Drug|Sitagliptin + Metformin|At least 180 days of continuous therapy with STG+MET after the first Rx for STG
16207838|NCT01333267|Drug|PTH (1-34) and PTHrP (1-36)|This is a dose escalation study to determine the maximum tolerable dose of Parathyroid Hormone-related Protein, PTHrP, or Parathyroid Hormone, PTH, that can be given safely over one week in healthy African-American volunteers. The investigators plan to infuse low doses of intravenous PTHrP or PTH to determine if it leads to a sustained and progressive suppression of bone formation as occurs in humoral hypercalcemia of malignancy (HHM) or an increase in bone formation as occurs in hyperparathyroidism (HPT). Additionally, the investigators will assess the direct influence of PTHrP and PTH on vitamin D metabolism, markers of bone turnover, and fractional excretion of calcium.
16207839|NCT01333254|Procedure|Intermittent urinary catheterisation|Patients randomised to the I group will urinate either in a toilet or in a bedpan or a diaper when needed. Bladder scan control will be performed on these patients at least every four hour. If the patient is unable to urinate and bladder scan indicates ≥ 450 ml urine in the bladder, the patient will be intermittent catheterised.
16207840|NCT01333241|Behavioral|Lifestyle behavior interventon grop|
16207841|NCT01333241|Other|Placebo Comparator: Control group|
16207842|NCT01333228|Other|Autologous bone marrow-derived endothelial progenitor cells|Intraarterial administration (hepatic artery) of autologous bone marrow-derived endothelial progenitor cells
16207843|NCT01333202|Other|Fresh lime|fresh lime were used every time the participants began to crave cigarettes and as often as they needed. To correctly use it, fresh lime needed to be washed and cut into several small pieces by 1st cutting each lime into quarters and then each quarter further into 4 pieces. When needed, subjects were told to suck each piece of lime and thereafter chew the lime skin. To maintain freshness, the remaining slices were to be covered with plastic wrap and stored in the refrigerator as soon as possible.
16207844|NCT01333189|Other|Weight-bearing biofeedback exercise|"Patients in the experimental group completed the same standard of care rehabilitation program as the control group. Thus, the experimental intervention was in addition to the standard intervention.
~Upon discharge to home, patients in the RELOAD group began the weight bearing (WB) biofeedback phase of the study. Patients participated in two 30-minute training sessions/week with a physical therapist for a total of 6 weeks, focusing on promoting WB symmetry using a progressive series of activities adapted to video games."
16207845|NCT01333189|Other|Standard of care exercise|Standard inpatient rehabilitation began on post-operative day 1 and lasted for an average of 3.2 days. After hospital discharge, two weeks of home rehabilitation (6 visits) were provided by physical therapists. Patients progressed to outpatient rehabilitation, consisting of 4 weeks of treatment. As such, 6 weeks of rehabilitation following hospital discharge was implemented for both groups.
16207846|NCT01333176|Procedure|"Point-of-care finger-poke HbA1c determination."|"All volunteers receive finger-poke HbA1c test. Result: If < 6: Offered a requisition to have gold standard testing for diabetes screening. If 6-6.5: Given requisition for FBG, HbA1c and OGTT. If A1c result >6.5: Counseled that they may have diabetes. Given requisition as above.
~Estimates about how many have undiagnosed diabetes will be calculated.
~Did the clients who were counseled to do so get follow-up blood tests?
~Were all the formal diagnostic tests performed?
~Did the formal tests correlate to the POC HbA1c test or was there significant discrepancy? Thus is this new test for diagnosing diabetes confirmed as a valid test for screening in First Nation Communities in Canada?
~Did the family physicians find this useful?"
16207847|NCT01333176|Procedure|HbA1c blood test|All candidates will have a HbA1c blood test (Finger poke)
16207848|NCT01333176|Procedure|HbA1c finger poke test|All study candidates will have the same HbA1c test performed
16207849|NCT01333176|Procedure|Blood test|HbA1c blood test
16207850|NCT01333176|Procedure|Blood test|HbA1c finger poke blood test
16207851|NCT01333163|Biological|Human GLP-1 (7-36) amide|2 hour IV infusion, 1,5pmol/min/kg.
16207852|NCT01333163|Biological|Isotone NaCl|2 hours IV infusion.
16207853|NCT01333150|Drug|Propranololhydrochlorid|One single dose of Propranolol tablet of 40 mg randomized in one of the two sessions
16207854|NCT01333150|Drug|Placebo|One single dose of placebo
16207855|NCT01333137|Drug|Gemcitabine and Carboplatin|Gemcitabine 1000 mg/m2/day on Days 1 & 8 and carboplatin at AUC 2 on Days 1 and 8 every 21 days.
16207856|NCT01333137|Drug|P276-00 along with Gemcitabine and carboplatin|In phase I run in period, P276 00 will be administered at starting dose of 100 mg/m2/day (and higher if tolerated) in 200 mL of 5% dextrose as an iv infusion over 30 minutes, on Days 1 to 5, along with gemcitabine 1000 mg/m2/day and carboplatin at AUC 2 on Days 1 & 8 every 21 days. In Phase 2 component, P276-00 will be administered at recommended phase II dose of P276-00 in combination with standard dose of gemcitabine and carboplatin.
16207857|NCT01333124|Radiation|chemoradiotherapy with Gemcitabine|All patients will receive gemcitabine 400 mg/m2 as an intravenous 30-min infusion on day 1, 8, 15, 22, and 29 with radiotherapy.After 4-6 week from end date of chemoradiotherapy, patients undergo preoperative evaluation including CT, PET, CA19-9, CEA. If the patient is feasible for resection on this evaluation, the surgery is performed in 1 to 2 weeks. After surgery, patients will receive gemcitabine 1000 mg/m2 as an intravenous 30-min infusion on day 1, 8, and 15 for every 28 days. Subjects will be treated for at least 1 cycle and to a maximum of four cycles of adjuvant chemotherapy unless there is documented relapse, unacceptable adverse events or withdrawal of consent.
16207858|NCT01333124|Radiation|Radiation: chemoradiotherapy with Gemcitabine|Radiation: chemoradiotherapy with Gemcitabine
16207859|NCT01333111|Drug|nonacog beta pegol|One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience
16207860|NCT01333111|Drug|nonacog beta pegol|One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience
16207861|NCT01333111|Drug|nonacog beta pegol|Patients will treat themselves with either a low or a high dose dependent on the severity of the bleeding episode
16207862|NCT01333098|Drug|Mifepristone|300mg per day, by mouth, for 21-28 days
16207863|NCT01333085|Drug|carboplatin|
16207864|NCT01333085|Drug|RAD001|
16207865|NCT01333085|Drug|paclitaxel|
16207866|NCT01333072|Drug|Aripiprazole|The starting dosage will be 2.0 mg/day. The dosage will be allowed to increase to 5.0 mg/day on day 4 and can be increased thereafter as judged clinically appropriate until the maximum dosage of 15 mg/day. The dosage will only be increased in 5.0 mg intervals. No dosage adjustments will be allowed for either drug after 4 weeks.
16208292|NCT01329900|Drug|Ofatumumab|1000 mg by vein on Day 1 and 2000 mg by vein on Day 8
16207867|NCT01333072|Drug|Risperidone|Children weighing 20-45 kg will receive an initial dose of 0.5 mg daily that will be increased to twice daily on day 4 (morning and bedtime). The dosage will be gradually increased in 0.5 mg increments to a maximum dose of 2.5 mg per day (1.0 mg in the morning and 1.5 mg at bedtime) by the fourth treatment week. A slightly accelerated dosage will be allowed for children who weigh more than 45 kg for a maximum dosage of 3.5 mg /day (McCracken et al 2002).
16207868|NCT01333059|Drug|Midazolam|
16207869|NCT01333059|Drug|Normal saline|
16207870|NCT01333059|Drug|Fentanyl|
16207871|NCT01333046|Biological|Antigen-Escalation Stage|"Antigen-Escalation Stage
~Each patient will receive 2 injections at the same dose (5 x 10^6 cells/m2), 28 days apart, according to the following schedules:
~Schedule One:
~Day 0: PRAME-specific T cells
~Day 28: PRAME- and SSX-specific T cells
~Schedule Two:
~Day 0: PRAME- and SSX-specific T cells
~Day 28: PRAME/SSX/MAGE-specific T cells
~Schedule Three:
~Day 0: PRAME/SSX/MAGE-specific T cells
~Day 28: PRAME/SSX/MAGE/NY-ESO specific T cells
~Schedule Four:
~Day 0: PRAME/SSX/MAGE/NY-ESO specific T cells
~Day 28: PRAME/SSX/MAGE/NY-ESO/Survivin-specific T cells"
16207872|NCT01333046|Biological|Dose-Escalation Stage|"Dose-Escalation Stage
~Three different dosing schedules will be evaluated. Each patient will receive 2 injections at the same dose, 14 days apart, according to the following dosing schedules:
~DL1: Day 0 and Day 14: 5 x 10^6 cells/m^2
~DL2: Day 0 and Day 14: 1 x 10^7 cells/m^2
~DL3: Day 0 and Day 14: 2 x 10^7 cells/m^2"
16207873|NCT01333046|Biological|azacytidine and multiTAA T cells Stage|"Up to 15 patients will be treated with 3 cycles of aza at a dose of 75 mg/m2 I.V. administered for 5 days/cycle followed, within 28 days of the last aza dose, by two infusions (on Day 0 and Day 14) of multi-TAA specific CTLs at a fixed dose of 1x10^7 cells/m2. If drug-related myelosuppression occurs aza dosing will be modified, according to the following:
~ANC >1,000 or Platelets >50,000 (or any other grade I AE attributable to aza)
~Adjustment: None
~ANC 500-1000 or Platelets 25,000-50,000 (or any other grade II-III AE attributable to aza)
~Adjustment: 50% dose reduction
~ANC <500 or any episode of febrile neutropenia or platelets <25,000 or any episode of bleeding attributed to thrombocytopenia (or any other grade IV or higher AE attributable to aza)
~Adjustment: Discontinue drug, can proceed with CTL infusion if eligible within 28 days of last aza infusion"
16207874|NCT01333046|Biological|Pediatric multiTAA T cells Stage|Patients < 18 years old will receive two infusions (on Day 0 and Day 14) of multi-TAA specific T cells at a fixed dose of 1x10^7 cells/m2. We will enroll and infuse at least 5 adolescents on the pediatric arm before opening to all patients.
16207875|NCT01333033|Drug|Oxaliplatin|Given IV
16207876|NCT01333033|Drug|Leucovorin Calcium|Given IV
16207877|NCT01333033|Drug|Fluorouracil|Given IV
16207878|NCT01333033|Drug|Carboplatin|Given IV
16207879|NCT01333033|Drug|Paclitaxel|Given IV
16207880|NCT01333033|Procedure|Positron Emission Tomography|Undergo PET/CT scan
16207881|NCT01333033|Procedure|Computed Tomography|Undergo PET/CT scan
16207882|NCT01333033|Radiation|Radiation Therapy|Undergo RT
16207883|NCT01333020|Other|cross-linking of an emulsion drink|This study will assess whether a subtle change in food structure (cross-linking of interfacial protein) can alter gastric emptying rate.
16207884|NCT01332994|Drug|rituximab [MabThera/Rituxan]|1 g intravenously at Week 16 and 18
16207885|NCT01332994|Drug|tocilizumab [RoActemra/Actemra]|8 mg/kg intravenously every 4 weeks for 12 weeks.
16207886|NCT01332994|Drug|tocilizumab [RoActemra/Actemra]|8 mg/kg intravenously every 4 weeks from Week 16 to Week 28
16207894|NCT01332955|Drug|Telaprevir|"Drug : telaprevir, Tablet, Oral, 750 mg, q8h, 12 weeks if associated with atazanavir or raltegravir
~Drug : telaprevir, Tablet, Oral, 1125 mg, q8h, 12 weeks if associated with efavirenz"
16207895|NCT01332955|Biological|pegIFN alfa-2a|Subcutaneous injection, 180 μg, once weekly, 48 weeks or 72 weeks
16207896|NCT01332955|Drug|Ribavirin|(weight-based dose) Tablet, Oral, 1000 mg for subjects weighing below 75 kg or 1200 mg for subjects weighing equal or over75 kg, once daily, 48 weeks or 72 weeks
16207897|NCT01332942|Drug|BAY85-3934|Subjects received an oral single dose of placebo tablet matched to the molidustat dose (BAY85-3934) on Day 1 followed by a washout day and once daily multipledose over 12 days (from Day 3 to Day 14).
16207898|NCT01332942|Drug|BAY85-3934|Subjects received an oral single dose of 5 mg of molidustat IR tablet on Day 1 followed by a washout day and once daily multiple-dose over 12 days (from Day 3 to Day 14).
16207899|NCT01332942|Drug|BAY85-3934|Subjects received an oral single dose of 10 mg of molidustat ( 2x 5mg IR tablets) on Day 1 followed by a washout day and once daily multipledose over 12 days (from Day 3 to Day 14).
16207900|NCT01332942|Drug|BAY85-3934|Subjects received an oral single dose of 25 mg of molidustat (1 x 20 mg IR tablet and 1 x 5 mg IR tablet) on Day 1 followed by a washout day and once daily multiple-dose over 12 days (from Day 3 to Day 14).
16207901|NCT01332942|Drug|BAY85-3934|Subjects received an oral single dose of 50 mg) of molidustat (2 x 20 mg IR tablets and 2 x 5 mg IR tablets) on Day 1 followed by a washout day and once daily multiple-dose over 12 days (from Day 3 to Day 14).
16207902|NCT01332942|Drug|BAY85-3934|Subjects received an oral single dose of 75 mg of molidustat (3 x 20 mg IR tablets and 3 x 5 mg IR tablets) on Day 1 followed by a washout day and once daily multiple-dose over 12 days (from Day 3 to Day 14).
16207903|NCT01332929|Drug|Bevacizumab|"5, 10 or 15 mg/kg, IV, on day 1, 15 and 29 plus radiation therapy of the whole brain.
~For level 0,1 and 2, a total dose of 30 Gy will be administered in 15 fractions of 2 Gy, from D15 to D33 with 5 fractions a week.
~For level 3,a total dose of 30 Gy will be administered in 10 fractions of 3 Gy, from D15 to D26 with 5 fractions a week."
16207904|NCT01332916|Procedure|cognitive tests and cerebral IRM|cognitive tests and cerebral IRM
16207905|NCT01332916|Procedure|cognitive tests and cerebral IRM|cognitive tests and cerebral IRM
16207906|NCT01332903|Drug|[14C] AZD5069|Single 120 mg oral dose administered on Day 1
16207907|NCT01332890|Other|Sequence 1|Period1(A) Period2(B) Period3(C) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days)
16207908|NCT01332890|Other|Sequence 2|Period1(C) Period2(A) Period3(B) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days)
16207909|NCT01332890|Other|Sequence 3|Period1(B) Period2(C) Period3(A) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days)
16207910|NCT01332890|Other|Sequence 4|Period1(C) Period2(B) Period3(A) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days)
16207911|NCT01332890|Other|Sequence 5|Period1(B) Period2(A) Period3(C) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days)
16207912|NCT01332890|Other|Sequence 6|Period1(A) Period2(C) Period3(B) A : Revaprazan 200mg/Day (multiple dose for 7days) B : Itopride 50mg/Day (multiple dose for 7days) C : Revaprazan 200mg plus Itopride 50mg(multiple dose for 7days)
16207913|NCT01332877|Behavioral|Enriched breakfast|high carbohydrate, high protein breakfast supplying 600 kcal as 50k% carbohydrate, 20% protein, 30% fat
16207914|NCT01332877|Behavioral|Control breakfast|Control breakfast providing 300 kcal, 13% carbohydrate, 40% protein, 48% fat
16207915|NCT01332864|Procedure|Osteopathic Manipulative Treatment (OMT)|O OMT applied to areas of somatic dysfunction other than the head region.
16207916|NCT01332864|Procedure|Light touch|Light touch applied to head region for 10 minutes with patient supine at rest.
16207917|NCT01332851|Behavioral|Promoting First Relationships (PFR)|PFR is a parenting intervention based on attachment theory and is strengths based. It is a 10 week intervention that is delivered in the home of the family.
16207918|NCT01332851|Behavioral|Resource and Referral|Needs assessment, followed with a resource packet sent by mail
16207919|NCT01332838|Procedure|Compression stockings|standard 30to 40 mm Hg thigh high compression stockings
16207920|NCT01332838|Device|compression stockings (Sigvaris )|Specialized monoleg compression
16207921|NCT01332825|Other|saline nasal irrigation|subjects irrigate with nasal saline daily for one week
16207922|NCT01332812|Drug|Dexamethasone|a dose of 8 mg of dexamethasone will be administered intravenously before induction of general anesthesia
16207923|NCT01332812|Other|control group|General anesthesia, without additional interventions
16207924|NCT01332799|Drug|allopurinol or placebo|Daily active drug (allopurinol administered orally) administered orally for 3 years.
16207925|NCT01332799|Other|Placebo|Sugar pill administered orally for 3 years.
16207926|NCT01332786|Drug|Tigecycline|"Dosage Form: one-hour intravenous infusion Dosage levels, frequency, duration: (3-week cycles)
~Level 1: 50 mg daily x 10 doses; 1 week rest
~Level 2: 100 mg daily x 10 doses; 1 week rest
~Level 3: 150 mg daily x 10 doses; 1 week rest
~Level 4: 200 mg daily x 10 doses 1 week rest
~Level 5: 250 mg daily x 10 doses; 1 week rest
~Level 6: 300 mg daily x 10 doses; 1 week rest
~Level 7: 350 mg daily x 10 doses; 1 week rest"
16207927|NCT01332773|Procedure|Artery first procedure|early identification of SMA to evaluate infiltration
16207928|NCT01332773|Procedure|No artery first procedure|conventional exposure and preparation (Kocher's manoeuvre) before transection of pancreatic parenchyma
16207929|NCT01332760|Other|narrow diameter heavy dental tool|8mm diameter, heavy periodontal tool made from steel
16207930|NCT01332760|Other|large diameter light weight tool|Periodontal tools (4-8) provided to dental practitioners to use for all dental scaling or cleaning. This tool handle diameter is 11 mm diameter and it is made from lightweight Delrin.
16207931|NCT01332747|Drug|safoof e muhazzil|"drug is composed of 5 herbal(Carum Carvi,Trachyspermum copticum,Foeniculum Vulgare,Origanum Vulgare,Ruta Graveolens) 1 animal origin (Lac)and 1 mineral origin (Borax) ingredients.
~to be given in a dosage of 5 gms twice daily"
16207932|NCT01332747|Drug|compressed tablet of safoof e muhazzil|"drug is composed of 5 herbal(Carum Carvi,Trachyspermum copticum,Foeniculum Vulgare,Origanum Vulgare,Ruta Graveolens) 1 animal origin (Lac)and 1 mineral origin (Borax) ingredients.
~compressed into tablets of 1 gm each+ binders qs. dose is 5 tablets twice daily"
16207933|NCT01332747|Drug|Atorvastatin|atorvastatin 10 mgs once daily
16207934|NCT01332734|Drug|Magnesium Sulfate|2 gram in 1 hour
16207935|NCT01332721|Drug|TRC105 and Bevacizumab|Escalating doses of i.v. TRC105 will be administered weekly beginning with 3 mg/kg in combination with 15 mg/kg bevacizumab given every 3 weeks. Patients will receive TRC105 treatment on Days 1, 8, and 15 and bevacizumab treatment on Day 1 of each 21-day cycle.
16207936|NCT01332708|Behavioral|high complex carbohydrates diet given in a diet group|diet groups that meet every week for eight weeks or more.
16207937|NCT01332695|Drug|ST101|tablets for oral administration
16207938|NCT01332695|Drug|Placebo|placebo to match
16207939|NCT01332682|Behavioral|Nutrition Counseling|Patients will meet once per week with dietitian for the first 6 weeks in 60 minute sessions. Dietitian will telephone each patient weekly for the final 6 weeks of counseling and support.
16207940|NCT01332682|Behavioral|Resistance Training and Nutrition Counseling|Patient will meet with an exercise specialist once per week for the first 6 weeks. Patient will receive guidance in a safe and appropriate exercise regimen based on specific medical history and preference. An exercise specialist will telephone weekly for consultation and support once per week for the final 6 weeks. Also, patient will meet once per week with dietitian for the first 6 weeks in 60 minute sessions. Dietitian will telephone each patient weekly for the final 6 weeks of counseling and support.
16208293|NCT01329900|Drug|Ifosfamide|3.33 gm/m2 by vein on Days 2, 3, and 4 continuously.
16207941|NCT01332669|Procedure|DebDox TACE|HCC patients will receive chemoembolization (TACE) using DC beads containing Doxorubicin. The objective is to give 2 vials of DC Bead (2ml per vial) loaded with 70-75mg of Doxorubicin per vial (Each vial contain 2ml of DC Bead, thus doxorubicin concentration will be of 35-37.5mg per ml of DC Beads)
16207942|NCT01332656|Drug|Ombrabulin (AVE8062)|"Pharmaceutical form:solution
~Route of administration: intravenous"
16207943|NCT01332656|Drug|Placebo|"Pharmaceutical form:solution
~Route of administration: intravenous"
16207944|NCT01332656|Drug|Paclitaxel|"Pharmaceutical form:solution
~Route of administration: intravenous"
16207945|NCT01332656|Drug|Carboplatin|"Pharmaceutical form:solution
~Route of administration: intravenous"
16207946|NCT01332643|Genetic|Preimplantation Genetic Diagnosis|All embryos in the test group reaching blastocyst stage will undergo embryo biopsy of 3-10 trophectoderm cells. The cells will be analyzed by array CGH to detect the presence or not of chromosome abnormalities. The embryos will be vitrified and those classified by array CGH as normal, thawed for replacement.
16207947|NCT01332630|Drug|TPI 287|"Starting dose Phase I: 160 mg/m2 by vein over 60 minutes on Days 1, 8, and 15 of every 28 day cycle.
~Starting Dose Phase II: Maximum tolerated dose from Phase I."
16207948|NCT01332630|Drug|Dexamethasone|6 mg by mouth at 12 hours and 6 hours prior to treatment. As alternative and based on the treating physician discretion, dexamethasone 10 mg by vein may be given 30-60 minutes prior to treatment with TPI 287.
16207949|NCT01332630|Drug|Benadryl|12.5-25 mg intravenous (IV) push 30-60 minutes prior
16207950|NCT01332630|Drug|Ranitidine|As H2 blocker 1mg/kg IV 30-60 minutes prior
16207951|NCT01332617|Drug|Simvastatin,Zoledronic Acid,Bortezomib,Bendamustine,Methylprednisolone.|"Simvastatin 80 mg PO daily starting day -2 through day 10.
~Zoledronic acid 4 mg IV over 15 minutes on day 1 and then monthly
~Bortezomib 1.3 mg/m2/day IV bolus on days 3,6 and 10.
~Bendamustine 100 mg/m2/day IV over 30 minute infusion on days 3 and 10.
~Methylprednisolone 1g/m2 IV over 30 minutes on days 1 and 8."
16207952|NCT01332604|Drug|GDC-0980|Oral escalating dose
16207953|NCT01332604|Drug|bevacizumab|Intravenous repeating dose
16207954|NCT01332604|Drug|capecitabine|Oral repeating dose
16207955|NCT01332604|Drug|mFOLFOX6|Intravenous repeating dose
16207956|NCT01332591|Procedure|Percutaneous coronary intervention|"PCI of significant stenoses of non-infarct coronary arteries"
16207957|NCT01332578|Drug|Paracetamol|Present in both test and active comparator
16207958|NCT01332578|Drug|Phenylephrine|Test product
16207959|NCT01332578|Drug|Ascorbic Acid|Test product
16207960|NCT01332565|Drug|GSK1349572|50mg tablet
16207961|NCT01332552|Drug|GSK2485852 70 mg|single dose
16207962|NCT01332552|Drug|GSK2485852 420 mg|single dose
16207963|NCT01332552|Drug|placebo|single dose
16207964|NCT01332552|Drug|placebo|Repeat dose, once daily for 3 days
16207965|NCT01332552|Drug|GSK2485852 420 mg|Repeat dose, twice daily for 3 days
16207966|NCT01332552|Drug|GSK2485852 420 mg|Repeat dose, TIDfor 3 days
16207967|NCT01332552|Drug|GSK2485852 630 mg|Repeat dose, twice daily for 3 days
16207968|NCT01332552|Drug|GSK2485852 70 mg + Ritonavir 100mg|single dose, day 1
16207969|NCT01332552|Drug|GSK2485852 210 mg + Ritonavir 100mg|single dose, day 1
16207970|NCT01332552|Drug|GSK2485852 210 mg +Ritonavir 100mg|single dose daily for 3 days
16207971|NCT01332539|Other|no intervention|non-interventional study
16207972|NCT01332513|Drug|Investigational Medicinal Product (MR1)|Ezogabine MR1 at a dose strength of 300 mg will be orally administered with approximately 250 milliliter (mL) of water to group A subjects during the bioavailability phase. For the food effect phase subjects in group G will be orally administered MR1 tablets at a dose strength of 600 mg.
16207973|NCT01332513|Drug|Investigational Medicinal Product (MR2)|Ezogabine MR2 at a dose strength of 300 mg will be orally administered to group B subjects with approximately 250 mL of water during the bioavailability phase. For the food effect phase subjects in group H will be orally administered MR2 tablets at a dose strength of 600 mg.
16207974|NCT01332513|Drug|Investigational Medicinal Product (MR3)|Ezogabine MR3 will be orally administered with approximately 250 mL of water to group C subjects during the bioavailability phase. For the food effect phase subjects in group I will be orally administered MR3 tablets at a dose strength of 600 mg.
16207975|NCT01332513|Drug|Investigational Medicinal Product (MR4)|Ezogabine MR4 will be orally administered with approximately 250 mL of water to group D subjects during the bioavailability phase. For the food effect phase subjects in group J will be orally administered MR4 tablets at a dose strength of 600 mg.
16207976|NCT01332513|Drug|Investigational Medicinal Product (MR5)|Ezogabine MR5 will be orally administered with approximately 250 mL of water to group E subjects during the bioavailability phase. For the food effect phase subjects in group K will be orally administered MR5 tablets at a dose strength of 600 mg.
16207977|NCT01332513|Drug|Investigational Medicinal Product (IR)|Ezogabine IR at dose strengths of 50 mg and 200 mg will be orally administered with approximately 250 mL of water.
16207978|NCT01332500|Drug|Sumatriptan/Naproxen combination|Sumatriptan and Naproxen Sodium
16207979|NCT01332500|Drug|other oral triptans|almotriptan, eletriptan, frovatriptan, naratriptan, rizatriptan, sumatriptan, zolmitriptan
16207980|NCT01332487|Drug|5ARI + AB|5ARI: Dutasteride or Finasteride and any AB: Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin
16207981|NCT01332474|Drug|BOTOX|BOTOX
16207982|NCT01332461|Drug|fluticasone propionate/salmeterol xinafoate combination|Patients filling a prescription for fluticasone/salmeterol combination as index drug
16207983|NCT01332461|Drug|Other maintenance Treatments (OMT)|OMT group includes tiotropium, ipratropium alone or in combination with albuterol, inhaled steroids, long acting beta agonists
16207984|NCT01332448|Drug|Orlistat 120|Orlistat 120mg tid
16207985|NCT01332448|Drug|Orlistat 60|Orlistat 60mg tid
16207986|NCT01332435|Drug|5ARI + AB|5ARI: Dutasteride or Finasteride AB: Doxazosin, Tamsulosin, Terazosin, or Alfuzosin
16207987|NCT01332422|Drug|Salmeterol and Fluticasone|Collection of safety data
16207988|NCT01332409|Drug|Salmeterol and Fluticasone|Administered according to the prescribing information in the locally approved label by the authorities.
16207989|NCT01332396|Drug|Lapatinib|
16207990|NCT01332383|Drug|Naratriptan|
16208936|NCT01324596|Drug|Bortezomib|Chemoimmunotheraphy
16207993|NCT01332357|Drug|Fluticasone propionate/salmeterol combination ED MD|Receipt of fluticasone propionate/salmeterol combination from the ED physician
16207994|NCT01332357|Drug|Fluticasone propionate/salmeterol combination OP MD|Receipt of fluticasone propionate/salmeterol combination from the OP physician
16207995|NCT01332344|Drug|Fluticasone propionate/salmeterol combination|Asthma subjects newly prescribed fluticasone propionate/salmeterol combination
16207996|NCT01332344|Drug|Inhaled corticosteroids|asthma subjects newly prescribed inhaled corticosteroids in clinical practice
16207997|NCT01332331|Drug|Ambrisentan - low dose|body weight 20 to 35 kg - 2.5 mg; body weight 35 kg and over - 5.0 mg
16207998|NCT01332331|Drug|Ambrisentan - high dose|body weight 20 to 35 kg - 5.0 mg; body weight 35 to 50 kg - 7.5 mg; body weight 50 kg and over - 10.0 mg
16207999|NCT01332318|Drug|XP13512|XP13512 once daily for 16 days
16208000|NCT01332318|Drug|Diphenhydramine|one 50 mg dose of diphenhydramine (DPH) on day 16
16208001|NCT01332318|Drug|Placebo|XP13512 placebo once daily for 16 days
16208002|NCT01332305|Drug|GEn (XP13512/GSK1838262)|Double-Blind Treatment Phase: 600 mg GEn (XP13512) orally, once daily for 3 days followed by 600 or 1200 mg on days 4-6, followed by 600 or 1200 or 1800 mg on days 7-9, followed by 600 or 1200 or 1800 or 2400 mg on days 10-84. Double-Blind Taper Phase: 600 or 1200 or 1800 mg GEn (XP13512) orally, once daily on days 85-86, followed by 600 mg or 1200 mg on days 87-88, followed by 600 mg on days 89-91
16208003|NCT01332305|Drug|Placebo|Placebo orally once daily
16208004|NCT01332292|Drug|Fluticasone furoate|Novel dry powder inhaler: 100µg per blister One blister strip containing fluticasone furoate micronised drug blended with lactose and a second blister strip containing lactose and magnesium stearate.
16208005|NCT01332292|Drug|Matching placebo|Novel dry powder inhaler: One blister strip containing lactose and a second blister strip containing lactose and magnesium stearate.
16208006|NCT01332279|Drug|everolimus|Given PO
16208007|NCT01332279|Drug|erlotinib hydrochloride|Given PO
16208008|NCT01332279|Procedure|biopsy|Correlative studies
16208009|NCT01332279|Other|laboratory biomarker analysis|Correlative studies
16208010|NCT01332279|Other|immunohistochemistry staining method|Correlative studies
16208011|NCT01332279|Genetic|polyacrylamide gel electrophoresis|Correlative studies
16208012|NCT01332279|Other|pharmacological study|Correlative studies
16208013|NCT01332279|Radiation|external beam radiation therapy|Undergo EBRT
16208014|NCT01332279|Genetic|microarray analysis|Correlative studies
16208015|NCT01332266|Drug|E7050|E7050 given orally at 200, 300, or 400 mg once daily.
16208016|NCT01332266|Drug|Cetuximab|Cetuximab is given at an initial dose of 400 mg/m2 given as a 2-hour intravenous (IV) infusion on Day 1 of Cycle 1, followed by a dose of 250 mg/m2 given as a 1-hour IV infusion on Day 8, Day 15, and Day 22 of Cycle 1, and Day 1, Day 8, Day 15, and Day 22 of each subsequent cycle.
16208017|NCT01332253|Drug|Intravenous ibuprofen|Participants will receive a single 10mg/kg dose of intravenous ibuprofen diluted in normal saline at the induction of anesthesia.
16208018|NCT01332253|Other|Normal Saline|Participants will receive a comparable weight based volume of normal saline as a placebo comparator at the induction of anesthesia.
16208019|NCT01332240|Procedure|Endoscopic ultrasonography|in order to stage the mediastinum
16208020|NCT01332227|Drug|Atazanavir|Capsules, Oral, 300mg, Once daily, 48 weeks
16208021|NCT01332227|Drug|Ritonavir (heat-stable)|Tablets, Oral, 100 mg, Once daily, 48 weeks
16208022|NCT01332227|Drug|Raltegravir|Tablets, Oral, 400 mg, Twice daily, 48 weeks
16208023|NCT01332227|Drug|Tenofovir/Emtricitabine|Tablets, Oral, 300/200 mg, Once daily, 48 weeks
16208024|NCT01332214|Drug|AZD2820|Subcutaneous Injection in abdomen or Thigh
16208025|NCT01332214|Drug|Placebo|Subcutaneous Injection in abdomen or Thigh
16208026|NCT01332201|Drug|Advagraf|oral
16208027|NCT01332201|Drug|Prograf|oral
16208028|NCT01332188|Drug|AC-170 0.05%|1 drop in each eye at 3 separate times during a 21 day period
16208029|NCT01332188|Drug|AC-170 0.1%|1 drop in each eye at 3 separate times during a 21 day period
16208030|NCT01332188|Drug|AC-170 0.24%|1 drop in each eye at 3 separate times during a 21 day period
16208031|NCT01332188|Drug|AC-170 0%|1 drop in each eye at 3 separate times during a 21 day period
16208032|NCT01332175|Device|Provent®|Nightly use of Provent® versus Placebo-Provent® versus CPAP
16208033|NCT01332175|Device|Placebo-Provent®|Nightly use of Provent® versus Placebo-Provent® versus CPAP
16208034|NCT01332175|Procedure|CPAP|Nightly use of Provent® versus Placebo-Provent® versus CPAP
16208035|NCT01332162|Device|Biventricular pacing|All patients will be pacing during two years
16208036|NCT01332162|Device|No Pacing|No Pacing during the first year. In the second year all patients will be pacing
16208037|NCT01332149|Drug|Pregabalin|"Subjects in the pregabalin group will start treatment with pregabalin capsule 150 mg/day for 1 week, then their dose will be increased to 300mg/day. After 1-week titration period, dose must be stable during study, no dose adjustment is permitted, and subject who cannot tolerate 300 mg/day pregabalin will be withdrawn.
~At the completion of the dose maintenance phase subjects will taper off study medication over a 1-week period. 300 mg/ day subjects will taper to 150 mg/ day."
16208038|NCT01332149|Drug|Placebo matched with pregabalin|Subject will take placebo matched with pregabalin twice a day.
16208039|NCT01332123|Device|Alignment perturbations|Increased foot plantar flexion, increased foot dorsal flexion, increased foot supination, increased foot pronation (always 2 degrees from the neutral position)
16208040|NCT01332110|Device|Knee abduction moment-reducing footwear|Patients in each study group will be asked to run using their assigned footwear at least 3 times per week (minimum 15 km per week) for six weeks. Each patient will document their perceived knee pain each week throughout the six week intervention.
16208041|NCT01332097|Drug|BCT197|
16208042|NCT01332097|Drug|Prednisone placebo|capsules
16208043|NCT01332097|Drug|BCT197 placebo|capsules
16208044|NCT01332084|Other|HA wheat cereals|HA wheat cereals used in SOTI test and as part of desensitization plan
16208045|NCT01332071|Drug|Rosiglitazone Maleate + Metformin 2 miligrams (mg) + 500 mg|Avandamet reference product
16208046|NCT01332071|Drug|Rosiglitazone Maleate + Metformin 4 miligrams (mg) + 1000 mg|Avandamet test product
16208048|NCT01332045|Procedure|continuous saphenous nerve block|Postoperative intermittent boluses of 15 Ml Ropivacaine 7,5 mg/Ml every 12 hours for three days
16208049|NCT01332045|Procedure|Saline boluses in nerve catheter|A nerve catheter will be placed in the adductor canal using saline instead of Ropivacaine for intermittent boluses.
16208050|NCT01332032|Behavioral|Reminder Letter|A letter sent to women reminding them that they are coming due or overdue for a mammogram. It contains a reminder that their doctor recommends mammography screening every 1-2 years; urges them to call a special number to a study scheduler to get assistance scheduling a mammogram and is signed electronically by their primary care provider. For women in the reminder letter only arm, who did not complete a mammogram within 12 months of the first reminder, a booster intervention (I.E. reminder letter) will be sent. The letter requests that a woman call in to schedule a mammogram, and reminds her that her PCP recommends she get one. Booster letters will be sent up to three times at annual intervals for those failing to get a mammogram
16208051|NCT01332032|Behavioral|Reminder Call|A reminder letter (as in the 1st group) is sent. If a woman does not call in to schedule a letter, 2 weeks later, a study scheduler will call her, remind her she is coming or is overdue, remind her that her PCP recommends screening every 1-2 years and offers to schedule a mammogram for her. For women in the reminder letter arm who did not complete a mammogram within 12 months of the first reminder, a booster intervention ( I.E.a reminder letter will be sent requesting that they call in to schedule a mammogram. The letter reminds her that her PCP recommends she get a mammogram. Those who do not respond within 7 days, will receive a scheduler call) will be repeated as necessary for up to 3 times.
16208052|NCT01332032|Behavioral|Counselor Call|Reminder letter s as above is sent. If subject does not call in to schedule within 2 weeks, second letter is sent with mammography educational booklet. Second letter reiterates reminder that PCP recommends screening. Has number to call to schedule. If subject does not schedule within 2 weeks, counselor will call. Protocol script includes tailored barriers counseling, correction of misinformation and motivational interviewing techniques. For those who did not complete a mammogram within 12 months of the first reminder, a booster intervention will be repeated annually for up to 3 times as necessary.Booster is reminder letter with pamphlet stressing the 4 reasons why women need regular mammograms.
16208053|NCT01332019|Drug|peginterferon beta-1a|Administered as specified in the treatment arm
16208054|NCT01332006|Procedure|Intrabone injection|All adults patients with hematological malignancies, lacking a HLA matched donor fulfilling the inclusion criteria, will undergo to intrabone HSC infusion of CB.
16208055|NCT01332006|Biological|Intra-bone cord blood hematopoietic stem cell transplantation|
16208056|NCT01332006|Biological|Intra-bone cord blood hematopoietic stem cell transplantation|Intra-bone injection of CB hematopoietic SCs after conditioning regimen
16208057|NCT01331993|Drug|VIMOVO (AstraZeneca)|VIMOVO (AstraZeneca) 500 mg naproxen/20 mg esomeprazole
16208058|NCT01331993|Drug|VIMOVO (Patheon)|VIMOVO (Patheon) 500 mg naproxen/20 mg esomeprazole
16208059|NCT01331993|Drug|Marketed enteric-coated naproxen formulation|Marketed enteric-coated naproxen formulation (manufactured by Roche) 500 mg tablet
16208060|NCT01331980|Device|Peripheral quantitative computed tomography (pQCT)|A pQCT scan of the non-dominant radius at the 4% and 65% sites will be conducted at a single study visit
16208061|NCT01331980|Device|Dual X-ray absorptiometry (DXA)|A total body DXA scan will be conducted at a single study visit
16208062|NCT01331967|Drug|Pioglitazone|Pioglitazone 15-30mg, once daily for 9 months
16208063|NCT01331954|Device|Ultrasonic ablation device|One or two HIFU procedures
16208064|NCT01331941|Drug|AMG 386 + Paclitaxel|15 mg/kg IV (in the vein) of AMG 386 weekly + 80 mg/m^2 IV (in the vein) 3 weeks on/1 week off, optional beginning week 6 until progression, unacceptable toxicity, or withdrawal of consent.
16208065|NCT01331941|Drug|AMG 386|15 mg/kg IV (in the vein) weekly beginning week 1 day 1 until progression, unacceptable toxicity, or withdrawal of consent.
16208066|NCT01331928|Drug|Capecitabine (Xeloda, Roche), Oxaliplatin (Sanofi-Aventis), Docetaxel (Sanofi-Aventis)|capecitabine orally 1000 mg/m2 twice daily, day1 to day 10, every 2 weeks plus oxaliplatin 85mg/m2 (2hrs IV infusion)on day1, every 2 weeks for 6 cycles, then shift to docetaxel 30 mg/m2(over 30-minute intravenous infusion) on day 1 and day 8 plus oral capecitabine 825 mg/m2 twice daily on day 1 to 14, every 3 weeks for 4 cycles.
16208067|NCT01331915|Biological|Theravac|"Three groups with three doses (50 - 150 - 250 mcg), four times every three weeks.
~Injection: intradermally and subcutaneously."
16208068|NCT01331902|Other|Maximal Hyperemia with Adenosine Followed by Nicorandil|Firstly FFR was measured with intravenous adenosine infusion (140 μg•min-1•kg-1) via femoral vein or antecubital vein. Secondly with intracoronary adenosine bolus injection (80μg, 40μg to LCA and RCA, respectively). Lastly with intracoronary nicorandil bolus injection (1mg followed by 2mg).
16208069|NCT01331902|Other|Maximal Hyperemia with Nicorandil Followed by Adenosine|Firstly FFR was measured with intracoronary nicorandil bolus injection (1mg followed by 2mg). Secondly with intravenous adenosine infusion (140 μg•min-1•kg-1) via femoral vein or antecubital vein. Lastly with intracoronary adenosine bolus injection (80μg, 40μg to LCA and RCA, respectively).
16208070|NCT01331876|Behavioral|Cognitive and behavioral Therapy|15 CBT sessions with a psychologist expert in OCD treatment
16208071|NCT01331863|Procedure|Airway and/or pulmonary Vessels Transplantation|Use of a stent-supported aortic allograft to prevent pneumonectomy in lung cancer SURGERY
16208072|NCT01331850|Drug|Copegus|1000 mg or 1200 mg daily oral doses for 24 weeks
16208073|NCT01331850|Drug|Copegus|1000 mg or 1200 mg daily oral doses for 48 weeks
16208074|NCT01331850|Drug|Pegasys|180 microgram subcutaneously once weekly for 24 weeks
16208075|NCT01331850|Drug|Pegasys|180 microgram subcutaneously once weekly for 48 weeks
16208076|NCT01331850|Drug|RO5024048|1000 mg oral doses twice a day for 24 weeks
16208077|NCT01331850|Drug|danoprevir|100 mg oral doses twice a day for 24 weeks
16208078|NCT01331850|Drug|ritonavir|100 mg oral doses twice a day for 24 weeks
16208079|NCT01331837|Drug|Etanercept|Participants will receive 50 mg etanercept subcutaneously weekly until switch to another RA therapy or up to 4.9 years.
16208080|NCT01331837|Drug|Tocilizumab|Participants will receive 8 mg/kg tocilizumab IV every 4 weeks until switch to another RA therapy or up to 4.9 years.
16208081|NCT01331824|Drug|Amrubicin|Patients will receive 35 mg/m2/day of amrubicin intravenously for 3 consecutive days as the initial dose starting on Day 1 of a 21-day cycle for up to 6 cycles
16208082|NCT01331811|Other|Development of a diagnosis algorithm|"At entry in the study, HIV infected children with suspected tuberculosis will undergo a complete evaluation including:
~interview on anamnesis
~clinical examination
~evaluation of HIV infection stage
~hematology and biochemistry tests
~CD4 count
~HIV viral load
~IGRA
~chest radiograph
~Abdominal ultrasonograph to detect abdominal lymphadenopathy
~Tuberculin skin test
~gastric aspirates, sputum and string tests according to the age of children
~nasopharyngeal aspirate
~stool sample
~lymph node fine needle aspirate or other specimen collection if applicable
~Diagnosis and treatment of all participating children will be done according to national guidelines. The children will be followed-up for 6 months until the end of their anti-TB treatment. For the analysis of data and the validation of the algorithm, children will be randomized into 2 groups. Data from Group I will be used to develop the algorithm; data from Group II will be used to validate it."
16208083|NCT01331798|Device|Cohera TissuGlu Surgical Adhesive|TissuGlu device used prior to closing of the flap in the abdominoplasty procedure.
16208084|NCT01331798|Procedure|Control- Standard of care|Control Arm- no TissuGlu device used. Standard abdominoplasty procedure followed.
16208085|NCT01331785|Drug|Midodrine|Midodrine 2.5 mg to 10 mg three times a day to increase systolic BP above 100 mmHgor by 10 mmHg
16208086|NCT01331772|Other|Control arm|Dietetic follow-up only
16208087|NCT01331772|Other|Intervention arm|Dietetic follow up + adapted physical activity
16208088|NCT01331759|Device|Neuropattern™|Neuropattern™ is a diagnostic tool aiming at measuring states of activity and reactivity of interfaces involved in the communication between the brain and peripheral bodily organs in stressful situations. The concept of Neuropattern™ assumes the states of the various interfaces to be describable by characteristic patterns of simultaneous activation of biological, psychological and symptomatic variables. Neuropattern™ assesses endophenotypes through the medical history, various questionnaires for the patient or study subject, analyses of saliva cortisol and the heart rate variability and derives hypotheses on recommendations for an effective and efficient treatment.These recommendations are based on evaluated medical and psychological therapeutic methods but specified through additional biopsychological understanding. This form of individualized therapy should reduce nonresponsiveness to therapy.
16208089|NCT01331746|Drug|APD515|20 mg oromucosal-oral administration qds for 7 days
16208090|NCT01331746|Drug|Placebo|qds for 7 days
16208091|NCT01331733|Drug|hMG-HP|
16208092|NCT01331733|Drug|hMG + GnRH antagonist|
16208093|NCT01331720|Drug|hMG-HP|
16208094|NCT01331707|Device|Resolute Integrity (Zotarolimus-eluting stent)|Third generation drug-eluting stent
16208095|NCT01331707|Device|Promus Element (Everolimus-eluting stent)|Third generation drug-eluting stent
16208096|NCT01331694|Drug|fluticasone/salmeterol combination (FSC) 250/50mcg|patients initiating treatment with fluticasone/salmeterol combination (FSC) 250/50mcg
16208097|NCT01331694|Drug|tiotropium|patients initiating treatment with tiotropium
16208098|NCT01331694|Drug|ipratropium bromide alone or in fixed dose combination with albuterol|patients initiating treatment with ipratropium/albuterol
16208099|NCT01331681|Biological|VEGF Trap-Eye (BAY86-5321)|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks (2Q4).
16208100|NCT01331681|Biological|VEGF Trap-Eye (BAY86-5321)|Participants received 2mg Intravitreal aflibercept injection (IAI) (EYLEA, VEGF Trap-Eye, BAY86-5321) every 4 weeks for 5 visits followed by injections every 8 weeks (2Q8).
16208101|NCT01331681|Procedure|Macular Laser Photocoagulation (Control)|Participants received laser treatment at baseline and as needed at visits at which laser retreatment criteria were met, but no more frequently than every 12 weeks.
16208102|NCT01331655|Drug|EE20/DRSP (BAY86-5300)|Day 1-120: 0.02 mg EE as ß-CDC / 3 mg DRSP (1 tablet/day); up to 120-day treatment period followed by a 4-day tablet-free interval
16208103|NCT01331655|Drug|EE20/DRSP/L-5-MTHF (BAY98-7071)|Day 1-120: 0.02 mg EE as ß-CDC / 3 mg DRSP / 0.451 mg levomefolate calcium (1 tablet/day) up to 120-day treatment period followed by a 4-day tablet-free interval
16208104|NCT01331655|Drug|EE20/DRSP/L-5-MTHF (BAY98-7071) + L-5-MTHF (BAY86-7660)|Day 1-24: 0.02 mg EE as ß-CDC / 3 mg DRSP / 0.451 mg levomefolate calcium per tablet (1 tablet/day) Day 25-28: tablets with 0.451 mg levomefolate calcium (1 tablet/day)
16208105|NCT01331629|Other|ART-THERAPIE|8 sessions of art therapy during radiotherapy
16208106|NCT01331616|Drug|Bevacizumab (Avastin)|Dosage is: 10 mg/kg every 2 weeks as monotherapy or in combination (unlabeled) with irinotecan. Patients will also receive Radiotherapy prior to beginning chemotherapy.
16208107|NCT01331590|Drug|G-CSF|
16208108|NCT01331590|Drug|Ifosfamide|
16208109|NCT01331590|Drug|Etoposide|
16208110|NCT01331590|Drug|Dexamethasone|
16208111|NCT01331590|Drug|Mesna|
16208112|NCT01331577|Behavioral|Cognitive Behavioural Training|Two day seminar
16208113|NCT01331577|Behavioral|Integrative Kinesiology Intervention|Two day seminar
16208114|NCT01331564|Behavioral|electronic intervention during pregnancy and postpartum|Electronically-mediated behavioral interventions to encourage women to gain an appropriate amount of weight during pregnancy and to follow a healthy lifestyle postpartum to minimize postpartum weight retention
16208115|NCT01331564|Behavioral|electronic intervention during pregnancy|Electronically-mediated behavioral interventions to encourage women to gain an appropriate amount of weight during pregnancy.
16208116|NCT01331564|Behavioral|Control|Control women will receive non-weight related content during both time periods at the project website.
16208117|NCT01331525|Biological|Ipilimumab|This trial will investigate the addition of the anti-CTLA4 antibody ipilimumab to conventional carboplatin and etoposide chemotherapy in extensive stage small cell lung cancer.
16208118|NCT01331499|Device|Bipolar Sealer (Aquamantys)|Standard of care blood sparing techniques along with the use of bipolar sealer
16208119|NCT01331499|Procedure|Standard of Care|Standard of care blood sparing techniques without the useof bipolar sealer
16208120|NCT01331486|Dietary Supplement|Hawthorn|Hawthorn standardized extract liquid capsule
16208121|NCT01331486|Dietary Supplement|Placebo capsule|Matched placebo liquid capsule
16208122|NCT01331473|Procedure|Carotid Artery Stenting with Proximal Protection|Carotid artery angioplasty and stenting with proximal embolic protection provided by the GORE Neuro Protection System
16208368|NCT01329263|Other|Menthol to non-menthol|Switch from smoking menthol to non-menthol cigarettes.
16208123|NCT01331473|Procedure|Carotid Artery Stenting without Protection|Carotid artery angioplasty and stenting without cerebral embolic protection
16208124|NCT01331460|Behavioral|RBT|"Intervention for Injection Drug Using Women:
~Incorporates elements of Reinforcement-Based Treatment and Women's Health CoOp to help prevent drug abuse (and promote drug abstinence) and lower risk of Human Immunodeficiency Virus, violence, and high-risk sexual behaviors."
16208125|NCT01331460|Other|Case-Management|"Standard Intervention:
~Incorporates standard practice elements like accessing resources, service linkage, monitoring the success of patient-service linkages, and advocating for the patient to help her meet her needs"
16208126|NCT01331447|Drug|exemestane|25 mg tablet
16208127|NCT01331434|Drug|exemestane|25 mg tablet
16208128|NCT01331421|Drug|exemestane|25 mg tablet
16208129|NCT01331408|Device|Macrolane VRF30|Injection of Macrolane VRF30 in buttocks. The sum of injected volume of Macrolane VRF30 at initial treatment and touch-up must not exceed 400 ml per Subject
16208130|NCT01331395|Other|Traditional Chinese Medicine|Active arm will receive Acupuncture with their IVF cycle.
16208131|NCT01331382|Dietary Supplement|Trans- resveratrol|All 23 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 250mg resveratrol with 20mg piperine or placebo on separate days (with a 48hr-14 day wash-out period between each treatment) with the order dictated by Latin square. Treatment was in the form of powder and administered in capsule form, in a double blind manner.
16208132|NCT01331382|Other|Placebo (silica)|All 23 participants who completed the study took part in 3 conditions; receiving either 250mg resveratrol, 250mg resveratrol with 20mg piperine or placebo on separate days (with a 48hr-14 day wash-out period between each treatment) with the order dictated by Latin square. Treatment was in the form of powder and administered in capsule form, in a double blind manner.
16208133|NCT01331369|Behavioral|Intensification of Care|Usual provided care plus social-psychological intervention: 6 consultation with doctors and 9 with community health workers, both oriented by protocol.
16208134|NCT01331369|Other|Usual Care|Usual care provided (medical and/or nurse consultation and medicines)
16208135|NCT01331356|Drug|Botox|One injection of botulinum toxin type A in the ganglion Impar in patients with chronic proctalgia
16208136|NCT01331343|Device|Guardian RT Telemetered Glucose Monitoring System|
16208137|NCT01331330|Device|Deep Brain Stimulation|Normal DBS Programming
16208138|NCT01331330|Device|Deep Brain Stimulation|Low Programming
16208139|NCT01331317|Drug|Paricalcitol|capsule, 1-2 micrograms daily for 90 days
16208140|NCT01331304|Drug|Lithium|600-900mg per day over 6 months
16208141|NCT01331304|Drug|Quetiapine|100-800mg a day over 6 months
16208142|NCT01331291|Drug|bosutinib|Taken orally
16208143|NCT01331278|Procedure|Total Knee Arthroplasty with Custom Cutting Blocks|Subjects randomized to this study group will undergo TKA with patient specific custom cutting blocks generated by pre-op MRI and a Biomet Vanguard knee implant
16208144|NCT01331278|Procedure|Total Knee Arthroplasty via Computer Assisted Surgery|Subjects randomized to this study group will receive TKA via computer assisted surgery and a Biomet Vanguard knee implant
16208145|NCT01331252|Other|semi-recumbent|Patient rests in a semi-recumbent body position
16208146|NCT01331252|Other|supine|Patient rests in a supine position
16208147|NCT01331239|Drug|LCI699|Osilodrostat 1 mg and 5 mg capsules, was prepared by Novartis and supplied to the Investigator. The capsule formulation of osilodrostat was later changed to tablets and this change was implemented in the study with Protocol amendment 6. Osilodrostat was open labeled 1 mg, 5 mg, 10 mg and 20 mg tablets.
16208148|NCT01331226|Behavioral|telephone counseling 3 sessions|3 sessions of telephone counseling
16208149|NCT01331226|Behavioral|telephone counseling 1 session|1 session of telephone counseling
16208150|NCT01331226|Behavioral|written materials only|written materials only
16208151|NCT01331213|Drug|Pregabalin|FDA approved medication (capsules) at 200mg dose.
16208152|NCT01331213|Drug|Placebo|Placebo capsules
16208153|NCT01331187|Procedure|Pocket-size ultrasonography|Routinely adding a ultrasound examination of the heart, pleura, great abdominal vessels, liver/gall bladder and kidneys at patients admittance to hospital
16208154|NCT01331187|Other|Usual care|No intervention, except for usual care (goal-directed diagnostics)
16208155|NCT01331174|Device|Pulsed short wave|The treatment was performed with 2 devices named Diatermed II (Carci, São Paulo, SP, Brazil), previously calibrated, carrying frequency of 27.12MHz, peak power of 250W, and pulse duration of 400µs. All these parameters are predetermined in the device according to the manufacturer. We used the maximum power provided by the machine in a pulsed form with a pulse frequency of 145Hz, resulting in a mean power of 14.5W.
16208156|NCT01331161|Biological|ZOSTAVAX|shingles vaccine, one dose
16208157|NCT01331148|Drug|Vitamin D|10,000 IU/caplet, patients receiving 240,000 IU to 600,000 IU cumulative Vitamin D dose based on weight.
16208158|NCT01331148|Other|Placebo|placebo with daily calcium/Vitamin D soft chews
16208159|NCT01331135|Drug|sirolimus|daily administration of sirolimus in oral form starting at a dose of 1 mg/m2 and increasing to a possible 3 mg/m2.
16208160|NCT01331122|Drug|droxidopa|Oral, 100, 200, 300, 400, 500, or 600 mg TID, duration includes two crossover periods of up to a 2 week titration period followed by a 4 week treatment period,with a washout between crossover periods.
16208161|NCT01331109|Drug|Milnacipran|maximum tolerated dose (50, 75, or 100 mg/day tablets); for 52 weeks.
16208162|NCT01331083|Drug|PX-866|PX-866: 8mg orally taken daily
16208163|NCT01331070|Other|cerebral fMRI|the central breathing control with cerebral fMRI in COPD patients
16208164|NCT01331070|Other|cerebral fMRI|the central breathing control with cerebral fMRI in Accepts Healthy Volunteers
16208165|NCT01331057|Other|NEEL test|An assessment for children in French with items extracted from the NEEL test
16208166|NCT01331057|Other|ELAL test|An assessment of mother tongue with the ELAL of AVICENNE
16208167|NCT01331057|Other|Interview|For parents of children include in the study: A semi -structured interview
16208168|NCT01331044|Dietary Supplement|Plumpy Nut|to RUTF will receive commercially available RUTF (Plumpy nut) in a total of 200 kcal/kg.day in a sequential manner (Plumpy nut will be offered ~ 125 kcal/kg in 1st 24 hours, ~ 150 kcal/kg in 2nd 24 hours, then~200k cal/kg by the third day).
16208616|NCT01327118|Drug|Prostaglandin F2alpha|intravenous injection
16208169|NCT01331044|Dietary Supplement|Khichuri and Halwa|"Day 1: Milk suji, 10ml/kg/ feed for 11 feed & halwa 10gm/kg; 2 feed per day 125kcal/kg.day
~Day 2: Milk suji, 10ml/kg/ feed for 11 feed & halwa 10gm/kg; 2 feed per day & khichuri 10gm/kg; 2 feed per day 150kcal/kg.day
~Day 3: Milk suji 100, 10ml/kg/ feed for 11 feed & halwa 10gm/kg; 2 feed per day & khichuri 10gm/kg; 2 feed per day 175kcal/kg.day
~Day 4: Milk suji 100, 10ml/kg/ feed for 11 feed & halwa 10gm/kg; 3 feed per day & khichuri 10gm/kg; 3 feed per day 200kcal/kg.day
~Day 5 onward: Milk suji 100, 10ml/kg/ feed 6 hourly (4 feed per day) & halwa 20gm/kg; 3 feed per day & khichuri 20gm/kg; 3 feed per day 200kcal/kg.day"
16208170|NCT01331018|Procedure|Bone Marrow Aspiration|Undergo bone marrow harvest
16208171|NCT01331018|Biological|Filgrastim|Given SC
16208172|NCT01331018|Biological|Genetically Engineered Hematopoietic Stem Progenitor Cells|Undergo infusion of genetically modified hematopoietic progenitor cell therapy
16208173|NCT01331018|Other|Laboratory Biomarker Analysis|Correlative studies
16208174|NCT01331018|Procedure|Leukapheresis|Undergo leukapheresis
16208175|NCT01331018|Drug|Methylprednisolone|Given IV
16208176|NCT01331018|Drug|Plerixafor|Given SC
16208177|NCT01331018|Drug|Prednisone|Given PO
16208178|NCT01331005|Drug|nepafenac 0.1% drops|One drop three times per day for one year
16208179|NCT01331005|Other|Nepafenac Vehicle|Placebo
16208180|NCT01330992|Other|Ocular light or darkness exposure|Ocular light or darkness exposure
16208181|NCT01330979|Drug|AR-12286 0.5% Ophthalmic Solution|Ophthalmic Solution
16208182|NCT01330966|Drug|pazopanib|Pazopanib 800 mg orally once daily will be started on Cycle 1 Day 1 and will be administered continuously for a 28-day cycle.
16208183|NCT01330953|Drug|Placebo|Single intravenous placebo dose.
16208184|NCT01330953|Drug|LY2928057|Single intravenous dose.
16208185|NCT01330940|Dietary Supplement|Orange soda|32 ounces per day
16208186|NCT01330927|Drug|VA106483|"Once daily oral dose of placebo for 2 nights
~Once daily oral dose of 0.5 mg VA106483 for 2 nights
~Once daily oral dose of 1 mg VA106483 for 2 nights
~Once daily oral dose of 2 mg VA106483 for 2 nights
~Once daily oral dose of 4 mg VA106483 for 2 nights
~Placebo: as above"
16208187|NCT01330901|Drug|Ustekinumab|Ustekinumab 90 mg given subcutaneously at weeks 0, 4, and 16
16208188|NCT01330875|Other|survey|no intervention. Only questionnaire after lumbar infiltration with steroids - effects on pain reduction
16208189|NCT01330849|Behavioral|ADHD Toolkit|For children allocated to the active intervention arm, teachers are trained to apply the ADHD Toolkit. Teacher will use the behaviour modification tool for 3 months. They are trained to select target behaviours causing impairment for the child and will apply a systematic approach of increased intensity of monitoring and feedback for the behaviour, including training of appropriate behaviour.
16208190|NCT01330849|Other|Waiting List Control group|Children in the control group will receive no specific intervention, but are promised that their teachers will apply the schoolkit for them after the study.
16208191|NCT01330823|Dietary Supplement|L-Carnitine|L-Carnitine, 4g/day, orally (Juice)
16208192|NCT01330823|Dietary Supplement|Placebo|tartaric acid same dose like L-Carnitine as placebo
16208193|NCT01330810|Drug|curcumin|standardized curcumin supplements containing curcumin, demethoxycurcumin and bisdemethoxycurcumin
16208194|NCT01330784|Drug|hMG-HP|
16208195|NCT01330771|Drug|hMG-HP/r-FSH|
16208196|NCT01330758|Drug|AZD8931|40 mg AZD8931 wet granulation tablet formulation
16208197|NCT01330758|Drug|AZD8931|40 mg AZD8931 roller compacted tablet formulation
16208198|NCT01330745|Other|sublingual microcirculatory evaluation|TNF, ICAM, syndecan-1, heparan sulfate
16208199|NCT01330719|Procedure|Diseased periodontal treatment|"Treatment includes scaling and root planing with systemic antibiotics, Amoxicillin 500 mg and Metronidazole 250 mg tid 7 days. At certain intervals after the scaling and root planing, your gums will be reevaluated. You will receive further surgical gum therapy only if your gums haven't shown improvement after first treatment on the reevaluation appointments. If surgery is needed, a bone substituting material may be necessary to fill the spaces where bone has been destroyed by the disease. Extraction of teeth might also be part of gum treatment if the disease is very severe. Re-treatment with antibiotics also may be necessary depending on the response after treatment. You are usually re-examined and receive additional cleanings every 3 to 6 months to ensure the disease does not come back."
16208200|NCT01330719|Procedure|Conventional periodontal treatment|Scaling and gum measurement will be taken to compare to the treated group.- If it is determined that you do not have this disease, a conventional cleaning is done, usually every 6 months. This is all part of normal clinical care.
16208201|NCT01330706|Drug|Polihexanide|The investigators compared intraoperative antiseptic irrigation using 0.9% saline solution and 0.1% polihexanide.
16208202|NCT01330693|Drug|Atomoxetine|Atomoxetine is FDA-approved for the treatment of ADHD symptoms in children. Single dose of 0.5 mg/kg at baseline visit. Then dose adjusted in an open-label design afterwards.
16208203|NCT01330693|Drug|Sugar Pill|In-active sugar pill randomly assigned at baseline visit
16208204|NCT01330680|Dietary Supplement|Coffee|40 mL dose of a decaffeinated preparation spiked with the addition of caffeine, at a dose of 3 mg/kg
16208205|NCT01330680|Dietary Supplement|Decaffeinated coffee|40 mL dose of decaffeinated coffee
16208206|NCT01330667|Dietary Supplement|Nutramigen Infant Formula|Investigators will advise to supplement with 10cc's of extensively hydrolyzed formula immediately following each breastfeeding until TSB declines.
16208207|NCT01330654|Drug|metoprolol|50mg PO BID starting two weeks prior to surgery. Patients will be reevaluated one week prior to surgery. If their pulse is above 70, the dose will be increased to 100mg BID. If the HR is 50-70, the dose will not be changed. If the pulse is below 50, the dose will be decreased to 25mg. This dose will be continued for thirty days after operation.
16208208|NCT01330641|Procedure|Injection of Subacromial Bursa|Injection of steroid and anesthetic to relieve pain
16208209|NCT01330628|Device|Turbo Elite Laser and Turbo Tandem Laser Guide Catheters|application of laser energy to remove blockage followed by standard balloon angioplasty
16208210|NCT01330628|Procedure|Balloon angioplasty|standard balloon catheters for PTA
16208211|NCT01330615|Drug|EMLA|The cream is applied as a thick layer to the wart and to the surrounding 1 to 2 mm and left on for 60 minutes under occlusion of Tegaderm dressing. The cream is then removed, and liquid cryotherapy applied using cryospray.
16208212|NCT01330615|Drug|Placebo|The cream is applied as a thick layer to the wart and to the surrounding 1 to 2 mm and left on for 60 minutes under occlusion of Tegaderm dressing. The cream is then removed, and liquid cryotherapy applied using cryospray.
16208213|NCT01330602|Behavioral|IMPRESS intervention|"The key elements of the IMPRESS intervention include:
~Promoting a healthy lifestyle
~Supporting lifestyle and risk modification
~Encouraging active self-management of risk and chronic disease
~Improving coordination of care
~Pharmacological therapy"
16208214|NCT01330589|Drug|Placebo|Non-active placebo for 7 days: PO/TID
16208215|NCT01330589|Drug|St. Johns Wort|For 7 days: 300mg PO/TID
16208216|NCT01330576|Procedure|cooling blanket/mattress|Therapeutic controlled hypothermia (33.5C) using cooling blanket/mattress
16208217|NCT01330576|Procedure|Standard treatment of care at normothermia|Standard treatment of care in 33.5C for 48 hours
16208218|NCT01330563|Drug|CKD-501, Ketoconazole|Subjects received single 0.5mg doses of CKD-501 alone in one period and, in the other period, Ketoconazole 200 mg twice daily for 5 day with the CKD-501 dose also co-administered with Ketoconazole on day 5.
16208219|NCT01330550|Dietary Supplement|High fiber sugar free biscuit|Dosage form:Biscuit, Dosage:1.94gram fiber/slice, Frequency:9 slices/meal;3 times/day. Duration:8 weeks
16208220|NCT01330524|Drug|Avastin and Triamcinolone|1.25 mg Avastin and 2mg Triamcinolone will be injected trough vitreal
16208221|NCT01330524|Other|placebo|2mg placebo
16208222|NCT01330485|Behavioral|Affect Regulation Training|The ART is a transdiagnostic, group-based intervention that has been developed to explicitly target emotion regulation skills (e.g., the abilities to be aware of, understand, accept, tolerate and modify negative emotions).
16208223|NCT01330485|Behavioral|Common Factor Control Condition|The CFC is an active treatment condition designed to control for unspecific effects of psychotherapeutic interventions.
16208224|NCT01330472|Drug|Xanax XR tablets 3 mg (sourced from Caugus)|Tablets, 3 mg, single dose
16208225|NCT01330472|Drug|Xanax XR tablets 3 mg (sourced from Barceloneta)|Tablets, 3 mg, single dose
16208226|NCT01330459|Drug|Hydrocodone/acetaminophen|Administration of 2 tablets 5/325mg hydrocodone/acetaminophen 45-90 minutes prior to procedure.
16208227|NCT01330459|Drug|Placebo|Administration of 2 tablets methylcellulose (placebo) 45-90 minutes prior to procedure.
16208228|NCT01330459|Drug|Ibuprofen|800 mg oral ibuprofen
16208229|NCT01330459|Drug|Lorazepam|2 mg oral lorazepam
16208230|NCT01330459|Drug|Lidocaine|20 ml 1% buffered lidocaine, injected
16208231|NCT01330446|Drug|Armodafinil|50 mg the first 3 days, 100 mg the next 4 days, and 150 mg for the remaining treatment period.
16208232|NCT01330446|Other|Placebo|1 by mouth every morning for a 28 day cycle.
16208233|NCT01330446|Behavioral|Questionnaires|Series of questionnaires completed at different time points before, during, and at study completion.
16208234|NCT01330433|Device|CoSeal Surgical Spray Group|"A patient randomized to the CoSeal treatment group will have CoSeal Surgical Spray applied at the end of their first staged procedure.
~The dose regimen is as follows:
~Patients weighing < 3kg will receive 1ml of CoSeal
~Patients weighing 3-10kg will receive 1-2ml of CoSeal
~Patients weighing >10kg will receive 2-4ml of CoSeal"
16208235|NCT01330420|Behavioral|Relaxation Response Resiliency Program for Depression|"The program combines lecture, skills training, symptom monitoring, and group sharing aimed at preparing patients to take active roles in managing their own health. Elements of the program include:
~Elicitation of the relaxation response through techniques such as diaphragmatic breathing and mindfulness.
~Examination and reversal of negative thought patterns.
~Physical movement, including stretching and yoga.
~Healthy eating and other positive lifestyle behaviors.
~Goal setting."
16208236|NCT01330407|Procedure|cryopreserved skin allografts.|
16208237|NCT01330407|Procedure|Cultured Epidermal Autografts|
16208238|NCT01330394|Device|transcranial Direct Current Stimulation|transcranial Direct Current Stimulation (tDCS, 5 x 7 cm2, 1 mA, during 10 min) will be applied over the left dorsolateral prefrontal cortex once a week for 5 consecutive weeks.
16208239|NCT01330381|Drug|prucalopride|"prucalopride
~subjects with weight ≤50kg: 0.04 mg/kg once daily as oral solution of 0.4 mg/ml
~subjects with weight >50 kg: prucalopride 2 mg tablet once daily"
16208240|NCT01330381|Drug|Placebo|Matching oral solution or oral tablets given once daily
16208241|NCT01330381|Drug|PEG 4000|
16208242|NCT01330355|Drug|Besivance|Besifloxacin hydrochloride 0.6% ophthalmic suspension, one drop instilled into infected eye, three times daily (TID) for 7 days
16208243|NCT01330355|Drug|Gatifloxacin|Gatifloxacin 0.3% ophthalmic solution one drop instilled into infected eye, TID for 7 days
16208244|NCT01330329|Behavioral|Standard behavioral treatment|Participants receive a standard behavioral weight loss program similar to that used in other large trials such as Look AHEAD and the Diabetes Prevention Program. Individuals will come to weekly group meetings for 6-months and will be instructed to reduce caloric intake, increase physical activity, and self-monitor their weight, eating, and exercise behaviors.
16208245|NCT01330329|Behavioral|SBT + technology system (SBT+FIT)|Participants will receive a standard behavioral weight loss program and will also be asked to use the Body Media FIT system as part of their weight loss intervention. Individuals will come to weekly group meetings for 6-months and will be instructed to reduce caloric intake, increase physical activity, and self-monitor their weight, eating, and exercise behaviors. Participants in this group will also wear an armband that measures energy expenditure and they will log their food intake on the internet.
16208246|NCT01330316|Drug|BI 201335|BI 201335 for 24 weeks
16208247|NCT01330316|Drug|PegIFN/RBV|PegIFN/RBV for 48 weeks
16208248|NCT01330303|Drug|Reference formulation|SECOTEX® (tamsulosin hydrochloride) 0,4 mg (Boehringer Ingelheim)
16208249|NCT01330303|Drug|Test formulation|tamsulosin hydrochloride 0,4 mg (Synthon BV)
16208250|NCT01330290|Drug|Neupro®|Neupro patches were prescribed by the treating physician according to the Summary of the Product Characteristics. Patients with idiopathic Parkinson's Disease (iPD) were treated for at least 1 month with a combination of Levodopa (L-DOPA) or other oral iPD medication and Neupro by the time the questionnaire was completed.
16208251|NCT01330238|Drug|Zoledronic acid vs. placebo|Single infusion of zoledronic acid or placebo
16208252|NCT01330199|Other|Pharmacokinetic Sampling|Blood plasma, Rectal, Cervical, and Vaginal Tissues and Secretions
16208617|NCT01327118|Drug|Isoton sodium chloride|intravenous injection
16208253|NCT01330186|Other|FMISO-PET, FDG-PET-CT and Magnetic Resonance Imaging (MRI)|This study involves 6 imaging sessions. One FMISO-PET before radiation therapy, one FDG-PET-CT before radiation therapy and one FDG-PET-CT during radiation therapy and tree Magnetic Resonance imaging (MRI) sessions with one session before radiation therapy, one session during radiation therapy and one sessions post radiation.
16208254|NCT01330173|Drug|Vismodegib|Given PO
16208255|NCT01330173|Other|Pharmacological Study|Correlative studies
16208256|NCT01330173|Other|Laboratory Biomarker Analysis|Correlative studies
16208257|NCT01330134|Drug|lidocaine|2ml 1% lidocaine placed onto surface of the skin immediately prior to 1% lidocaine subcutaneous injection
16208258|NCT01330134|Drug|lidocaine|1% lidocaine subcutaneous injection alone
16208259|NCT01330121|Other|Pharmacist Counseling|"Pharmacist Counseling includes but is not limited to:
~Reviewing and explaining their medications (dosing, side effects, route) Reviewing symptoms and complications of hyper and hypoglycemia Defining glycemic & non-glycemic goal levels Explaining the importance of compliance with medications & appointments Educating on the basics of nutrition and physical activity"
16208260|NCT01330108|Drug|ambrisentan|ambrisentan 2.5mg, 5mg, & 10mg. Daily dosage.
16208261|NCT01330095|Dietary Supplement|Administration of Bifidobacterium bifidum|Administration of Bifidobacterium bifidum to very low birth weight infants
16208262|NCT01330082|Other|Adjunctive Photodynamic Therapy|using Light-emitting diod(LED) (625-635nm,200mw/cm2 ,30 s for each site, fotoson CMS Dental ,Denmark) in the presence of toluidine blue O (TBO)
16208263|NCT01330082|Other|Light-emitting diod Irradiation|625-635nm,200mw/cm2 ,30 s for each site, fotoson CMS Dental ,Denmark
16208264|NCT01330082|Other|applying Photosensitizer|toluidine blue O is applied at the bottom of each periodontal pocket
16208265|NCT01330056|Procedure|FOPS|"Functional organ preservation (FOPS) as a first-line treatment modality
~Postoperative RT or CRT may be included for the patients of this group."
16208266|NCT01330056|Radiation|CRT|"Concurrent chemoradiotherapy as a first-line treatment modality
~Salvage surgery may be applied for the patients with persistent or recurrent cancers after RT or CRT"
16208267|NCT01330043|Drug|Bupropion|Both groups received the same pharmacotherapy per protocol. During open label treatment, all received CBT and bupropion and NRT patch. At week 10 those who continued to smoke were switched to varenicline through week 26. At week 10 those who are abstinent and reported low levels of craving and low levels of depression symptoms were withdrawn from study medications. Those who were abstinent but reported difficulty with craving or depression symptoms remained on bupropion and NRT through week 26. Medication was not available after week 26.
16208268|NCT01330043|Drug|Nicotine patch|Both groups received the same pharmacotherapy per protocol. During open label treatment, all received CBT and bupropion and NRT patch. At week 10 those who continued to smoke were switched to varenicline through week 26. At week 10 those who are abstinent and reported low levels of craving and low levels of depression symptoms were withdrawn from study medications. Those who were abstinent but reported difficulty with craving or depression symptoms remained on bupropion and NRT through week 26. Medication was not available after week 26.
16208269|NCT01330043|Drug|Varenicline|Both groups received the same pharmacotherapy per protocol. During open label treatment, all received CBT and bupropion and NRT patch. At week 10 those who continued to smoke were switched to varenicline through week 26. At week 10 those who are abstinent and reported low levels of craving and low levels of depression symptoms were withdrawn from study medications. Those who were abstinent but reported difficulty with craving or depression symptoms remained on bupropion and NRT through week 26. Medication was not available after week 26.
16208270|NCT01330030|Drug|Selegiline|6mg/24 hrs for 8 weeks
16208271|NCT01330030|Other|matching placebo|placebo/24hrs for 8 weeks
16208272|NCT01330017|Drug|Phenylephrine HCl|10-mg immediate-release tablets, orally, up to 4 tablets per dose every 4 hours, for 7 days
16208273|NCT01330017|Drug|Placebo|Placebo tablets, orally, up to five tablets per dose every 4 hours, for 7 days
16208274|NCT01330017|Drug|Loratadine|10-mg tablets, orally, once per day at a dose not to exceed 10 mg in a 24-hour period.
16208275|NCT01329991|Drug|PLX5622|PLX5622 drug substance is an achiral,small molecule Fms kinase inhibitor. The drug product is available in capsule form, to be taken orally, in a dosage strength of 100 mg with matching placebo
16208276|NCT01329991|Drug|Placebo|Matching placebo for PLX5622
16208277|NCT01329978|Drug|Sofosbuvir|Sofosbuvir (SOF) administered as a 400 mg tablet orally once daily
16208278|NCT01329978|Drug|RBV|Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
16208279|NCT01329978|Drug|PEG|Pegylated interferon alfa-2a (PEG) 180 μg administered once weekly by subcutaneous injection
16208280|NCT01329965|Drug|LPS (reference endotoxin, E. coli O113:H10:K:neg, manufactured under GMP)|LPS or placebo (saline-salt water) will be injected (at approximately 7:30 am) in this catheter by a trained GCRC staff member involved with this study. Participants will not be told if they have received the drug or placebo. The LPS is a sterile solution of protein-free endotoxin which will be injected at a dose of 0.6 ng/kg body weight. Blood samples will be collected from a venous catheter for the first 12 hours and by venipuncture thereafter. Subjects will be continuously monitored by trained nursing staff for blood pressure (q 15 minutes) and body temperature (q 30 minutes), and the study will have physician oversight.
16208281|NCT01329939|Drug|Montelukast|Age-dependent dose, nightly, 24 weeks
16208282|NCT01329939|Drug|Placebo|Age-dependent dose, nightly, 24 weeks
16208283|NCT01329939|Drug|Montelukast|Age-dependent dose, nightly, 24 weeks
16208284|NCT01329939|Drug|Placebo|Age-dependent dose, nightly, 24 weeks
16208285|NCT01329926|Procedure|Harvesting of neural stem cells|During neurosurgical procedures, tissue samples are obtained along trajectory of implanted electrodes or removal of stimulators previously implanted.
16208286|NCT01329913|Drug|MK-6325|Two 100 mg capsules, orally, once per day for 7 days
16208287|NCT01329913|Drug|Placebo to MK-6325|Two 100 mg capsules, orally, once per day for 7 days
16208288|NCT01329913|Drug|MK-6325|Four 100 mg capsules, orally, once per day for 7 days
16208289|NCT01329913|Drug|Placebo to MK-6325|Four 100 mg capsules, orally, once per day for 7 days
16208290|NCT01329913|Drug|MK-6325|Eight 100 mg capsules, orally, once per day for 7 days
16210322|NCT01313494|Drug|Placebo|Placebo tablets
16208294|NCT01329900|Drug|Etoposide|150 mg/m2 by vein over 2 hours every 12 hours Days 2, 3, and 4 for 6 doses.
16208295|NCT01329900|Drug|Mesna|"2 gm/m2 by vein over 1 hour on Day 2 (given before Ifosfamide starts)
~2.66 gm/m2/day by vein continuous infusion given over 24 hours daily for 3 days starting on Day 2 (together with Ifosfamide)
~After Ifosfamide/Mesna, 2 gm/m2 by vein given over 12 hours for one dose."
16208296|NCT01329900|Drug|G-CSF|6 mcg/kg subcutaneously twice a day on day 6 (rounded off to the nearest vial) until completion of apheresis.
16208297|NCT01329900|Procedure|Stem Cell Collection|Blood stem cells will be collected when blood counts have returned to normal (about 10-16 days after chemotherapy). Stem cell collection takes about 4 hours each time.
16208298|NCT01329887|Drug|ketanserin|ketanserin administration is started and increase, guided by the effect on sublingual MFI, dosage is 0,03mg/kg/hr
16208299|NCT01329874|Procedure|Type of block injection|Patients will be selected from a group with acute irreversible pulpitis in mandibular molars. Half of the patients randomly selected for receiving gow gates block injection and half will receive traditional inferior block injection by 3.6 ml Lidocaine plus epinephrine.Teeth with no response to anesthetizing will be randomly divided into two group of either buccal or lingual infiltration.
16208300|NCT01329861|Behavioral|Guided Internet-based cognitive behavioural treatment|Eight weeks internet-based cognitive behavioural treatment. Treatment consisted of education, cognitive skills acquisition, behavioural rehearsal, generalization and maintenance.
16208301|NCT01329835|Behavioral|Lifestyle counseling|4 prenatal sessions based on principles of motivational interviewing and positive reinforcement
16208302|NCT01329835|Other|brochure|brochure given after randomization
16208303|NCT01329822|Behavioral|Caloric restriction|Caloric restriction
16208304|NCT01329809|Drug|Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)|intratumoral or intravenous dosage: 10e9 pfu Intravenous: administered over 60 minutes Intratumoral: direct injection into a single liver lesion
16208305|NCT01329796|Drug|Lignocaine|Intrauterine flushing, pertubation, three treatments given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
16208306|NCT01329796|Drug|Ringers Solution|Intrauterine flushing, pertubation, given preovulatory at cycle day 6-12 in three sequential menstrual cycles.
16208307|NCT01329783|Other|maraviroc|No intervention is distributed during this trial.
16208308|NCT01329770|Dietary Supplement|Ascorbic Acid (Vitamin C) and Alpha-tocopherol (Vitamin E)|"Vitamin E (D-alpha-Tocopherol) 10 mg/kg/day (with a maximum of 600mg/day)
~Vitamin C (L-Ascorbic Acid) 10 mg/kg/day (with a maximum of 800mg/day) For 12 weeks"
16208309|NCT01329770|Dietary Supplement|Placebo|Two daily dose of placebo, administered at breakfast and dinner for 12 weeks
16208310|NCT01329757|Drug|GH|Administration of a subcutaneously injected daily dose of GH (0.4mg)for 1 year
16208311|NCT01329757|Drug|Placebo|Administration of a subcutaneously injected daily dose of placebo for 1 year
16208312|NCT01329744|Drug|mecasermin|a subcutaneous injection twice a day
16208313|NCT01329744|Drug|Placebo control|Subcutaneous injection given twice per day of placebo compound, for 24 weeks
16208314|NCT01329731|Drug|elmex® gelée|1.25% fluoride (elmex® gelée) Dosage: Weekly brushing with 0.5g of respective gel Route: Intraoral topical
16208315|NCT01329731|Drug|negative control (placebo)|0% fluoride (negative control) Dosage: Weekly brushing with 0.5g Route: Intraoral topical
16208316|NCT01329718|Other|Blood Sample|Blood sample collection
16208317|NCT01329705|Device|Ankle Dorsiflexion Dynasplint|"Dynamic splinting utilizes the protocols of Low-Load Prolonged Stretch (LLPS) with calibrated adjustable tension to increase Total End Range Time (TERT)to reduce contracture. The Dynasplint or Experimental group will add this therapy to their standard of care regimen"
16208318|NCT01329705|Other|Standard of care|"Patients will begin a 12 week course of physical therapy with once-weekly therapy appointment, focusing on:
~range of motion stretching of the Achilles tendon, hamstrings, hip flexors and any other tight musculature
~strengthening of tibialis anterior to allow dorsiflexion in swing phase of gait as well as strengthening of other weak musculature
~gait training to improve heel strike and toe off, stride length, and gait progression
~sensory, proprioceptive training in foot position and degree of plantarflexion or dorsiflexion
~no electric stimulation (e-stim) will be utilized"
16208319|NCT01329692|Behavioral|Lifestyle counseling|Weeks 1 and 2 consist primarily of a review of current dietary habits with initiation of a food journal; a basic review of macronutrients and metabolism; and the beginning of a weekly exercise regimen. Weeks 3, 4, & 5 introduces counseling, with specific emphasis on emotional aspects of eating and behavioral modification strategies. Week 6 focuses on the metabolic impact of exercise, and includes an exercise session with a personal trainer. Week 7 incorporates a question and answer session with a sharing of discoveries, as well as an option for additional individual follow-up as needed. During this period, patients will also be given access to an interactive web-based tool providing additional emphasis on the aforementioned components and clinician follow-up.
16208320|NCT01329679|Dietary Supplement|Energy Drink|Energy drink, 2oz twice daily for 7 days
16208321|NCT01329679|Other|Placebo|Water, lime juice and cherry flavoring
16208322|NCT01329666|Dietary Supplement|Placebo|Subjects will receive placebo vitamin D3, 1 pill weekly for 12 weeks.
16208323|NCT01329666|Dietary Supplement|Vitamin D3|"Baseline:
~50,000 IU/week for 8 weeks
~Week 8:
~Subjects with D3 less than 30 ng/ml: 50,000 IU/week for 4 weeks.
~Subjects with D3 25-OHD at or above 30 ng/ml: 50,000 IU/every 2 weeks for 4 weeks."
16208324|NCT01329653|Behavioral|aerobic training|12 weeks of aerobic training, 4X/week
16208325|NCT01329653|Behavioral|Wait list|wait list control condition
16208326|NCT01329640|Device|Drug: Paclitaxel; trastuzumab; doxorrubicin; cyclophosphamide|"Paclitaxel 100mg/m2 once a week for 8 weeks concomitant to trastuzumab 4mg/kg dose attack after 2mg/kg once a week for 8 weeks followed by;
~Doxorrubicin 24mg/m2 once a week concomitantly with oral cyclophosphamide 100mg/day (flat dose) concomitantly with trastuzumab 2mg/kg for 9 weeks"
16208327|NCT01329627|Drug|Paclitaxel/doxorubicin/cyclophosphamide|"Metronomic chemotherapy as described below:
~Paclitaxel 100 mg/m2 once a week for 8 weeks followed by;
~Doxorubicin 24 mg/m2 once a week concomitant to oral cyclophosphamide 100 mg/day (fix dose) for 9 weeks."
16208328|NCT01329627|Drug|Paclitaxel/doxorubicin/cyclophosphamide|"Metronomic chemotherapy as described below:
~Paclitaxel 100 mg/m2 once a week for 8 weeks followed by; Doxorubicin 24 mg/m2 once a week concomitant to oral cyclophosphamide 100 mg/day (fix dose) for 9 weeks."
16208329|NCT01329614|Behavioral|Cue Extinction Training|Repeated exposure to cigarette cues while receiving Nicotine Replacement Therapy.
16208330|NCT01329614|Drug|Nicotine Replacement Therapy|Study doctor applies a nicotine patch to the participant's shoulder blade. The patch dose is blinded by placement of a Bandaid over the patch itself.
16208331|NCT01329614|Behavioral|Cue Extinction Therapy|Participant is repeatedly exposed to cigarette cues without being allowed to partake in nicotine use.
16208332|NCT01329614|Behavioral|Progressive Muscle Relaxation|Participant relaxes muscles in her body, lead through the process using guided imagery and breathing techniques.
16208333|NCT01329601|Behavioral|StaCog, stage specific cognitive Intervention|StaCog intervention to improve cognitive performance and activities of daily living in AD and MCI
16208334|NCT01329601|Behavioral|booklet based training|Home based training of episodic memory using paper-pencil exercizes
16208335|NCT01329588|Drug|Monthly antibiotic|Azithromycin 1g per os once at months 1, 4 and 7 Ciprofloxacin 500 mg per os once at months 2, 3, 5, 6, 8 and 9
16208336|NCT01329588|Drug|Monthly placebo|Azithromycin placebo (sugar pill) per os once at months 1, 4 and 7 Ciprofloxacin placebo (sugar pill) per os once at months 2, 3, 5, 6, 8 and 9
16208337|NCT01329562|Drug|Treximet|Tablet for oral administration contains sumatriptan 85mg / naproxen sodium 500mg.
16208338|NCT01329562|Drug|Placebo|A placebo tablet matching Treximet for oral administration.
16208339|NCT01329549|Drug|BIBF 1120 (high) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min|BIBF 1120 twice daily along with standard therapy of PLD + CBDCA
16208340|NCT01329549|Drug|BIBF 1120 (medium) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min|BIBF 1120 twice daily along with standard therapy of PLD + CBDCA
16208341|NCT01329549|Drug|BIBF 1120 (low) + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min|BIBF 1120 twice daily along with standard therapy of PLD + CBDCA
16208342|NCT01329510|Device|One-night polysomnographic recordings|One-night polysomnographic recordings before and during methylphenidate treatment.
16208343|NCT01329497|Other|systemic dietary instruction|systemic dietary instruction based on continuous quality improvement (CQI) team-oriented approach
16208344|NCT01329484|Behavioral|Reminiscence therapy|Personalized reminiscence therapy using a computerized system
16208345|NCT01329484|Behavioral|Cognitive training|Cognitive training using a computerized system
16208346|NCT01329484|Other|No treatment|Participants in the control group will receive neither of the 2 experimental interventions or any other similar interventions.
16208347|NCT01329445|Other|DeNovo NT, Natural Tissue Graft|DeNovo NT Natural Tissue Graft of 1 or 2 lesions up to 5 cm squared in area.
16208348|NCT01329432|Procedure|Take care|In TAKE CARE procedure all premature infants who suffered from respiratory distress syndrome (RDS) received 100 mg/kg of porcine surfactant preparation via an intratracheal catheter during spontaneous breathing.
16208349|NCT01329432|Procedure|InSurE|infants treated with InSurE procedure were intubated and ventilated to receive surfactant and placed on nCPAP rapidly after surfactant administration.
16208350|NCT01329419|Drug|adefovir dipivoxil|Basically there is no treatment allocation. Subjects who would be administered of adefovir at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.
16208351|NCT01329406|Drug|Milnacipran|1 tablet (100mg) by mouth twice daily for 28 days
16208352|NCT01329406|Drug|Placebo|1 tablet by mouth twice daily for 28 days
16208353|NCT01329393|Behavioral|Benefits Management|Money-management intervention consisting of brief advice on budgeting, assessment of ability to follow a budget, and assessment of need for a representative payee.
16208354|NCT01329393|Behavioral|Illness Management and Recovery|Recovery Oriented Training in Biopsychosocial Model of Stress and How to Cope with Stress
16208355|NCT01329367|Behavioral|Control group|"Subjects will receive Nutritional education together with weight management counselling for overweight and obesity.
~-10 weekly personal interviews with a registered nutritionist for body weight control."
16208356|NCT01329367|Behavioral|Protein group|"Participants will receive Nutritional education and personalised structured meal plan with a calorie restricted diet (20-40% of the subject's energy expenditure at baseline) according to obesity degree, encouraging high consumption of legumes and fish (protein rich diets).
~-10 weekly personal interviews with a registered nutritionist for body weight control."
16208357|NCT01329367|Behavioral|Antioxidant group|"Participants will receive Nutritional education and personalized structured meal plan with a calorie restricted diet (20-40% of the subject's energy expenditure at baseline) according to obesity degree, encouraging high consumption of fruits and vegetables (antioxidant rich diets).
~-10 weekly personal interviews with a registered nutritionist for body weight control."
16208358|NCT01329354|Biological|Autologous effector lymphocytes expanded ex-vivo|Maintenance therapy with Rituximab every two months is the standard of care for patients with follicular lymphoma after induction therapy. The intervention consists on the administration of autologous effector lymphocytes expanded ex-vivo every two Rituximab administrations.
16208359|NCT01329341|Other|Service Dogs|Service dogs will be trained to help Veterans with PTSD
16208360|NCT01329328|Device|vibrating platform (Bioplate RF)|whole body vibration exercise with multiple positions, with or without localized delivery of heating radiofrequency
16208361|NCT01329315|Behavioral|BMI-T|Brief Motivational Intervention (BMI-T): social worker/therapist-delivered intervention (25-minute tailored structured module).
16208362|NCT01329315|Behavioral|BMI-C|Computer-delivered intervention (BMI-C): computerized tailored 25-minute intervention.
16208363|NCT01329302|Procedure|Direct aspiration needle Echo tip® Cook® single Lumen and Follicular flushing with double lumen needle Echo tip® Cook® Double Lumen Aspiration|In addition to direct aspiration of the follicular fluid all follicles are flushed with flushing solution, 20CC of flushing medium( Flushing Medium MediCultâ France) is provided for all the procedure and flushing medium is collected separately from direct fluid
16208364|NCT01329289|Drug|SOM230|60 mg intramuscularly (IM) on day 1 of each 28 day cycle
16208365|NCT01329289|Drug|Bortezomib|1.3 mg/m2 intravenously (IV) on days 1, 4, 8, and 11 of each cycle. Bortezomib will be infused by IV push.
16208366|NCT01329289|Drug|Dexamethasone|20 mg orally on day of and day after bortezomib (Days 1, 2, 4, 5, 8, 9, 11, 12).
16208367|NCT01329276|Drug|Symbicort® forte Turbohaler®|320 µg budesonide / 9 µg formoterol fumarate dihydrate
16210371|NCT01313104|Procedure|screening method|Undergo anal Pap smear
16208369|NCT01329250|Drug|Moxifloxacin|Patients will start on a standard dose of MFX 400 mg once daily. After 8 days the dose will be increased to 600 mg once daily and on the 15th day of treatment, the dose of MFX will be escalated to 800 mg. In patients who have been treated with rifampicin (RIF) in the past three weeks prior to start of MFX treatment an additional washout period of 3 weeks to reduce the rifampicin induced enzymatic activity will precede the dose escalation.
16208370|NCT01329237|Other|dynamic physical exercise and OCT imaging|supine dynamic physical exercise during coronary angiography and optical coherence tomography OCT imaging of the coronary stent
16208372|NCT01329198|Device|NeuroPace RNS® System Deep Brain Stimulator|Utilizes a signal that the device detects and will respond to with an electrical pre-defined pulse if the signal is encountered.
16208373|NCT01329185|Drug|Valganciclovir|Valganciclovir 450mg twice a day for 14 days prior to transplant date
16208374|NCT01329185|Drug|Placebo|1 capsule twice a day for 14 days prior to transplant date
16208375|NCT01329172|Other|polyunsaturated fatty acids n-3|polyunsaturated fatty acids n-3 1 gram per day during two months
16208376|NCT01329172|Other|placebo|sun flower oil with Poly Unsaturated Fatty Acid 1g/day
16208377|NCT01329133|Procedure|Deep Brain Stimulation (DBS)|In a first time: Implantation of DBS electrodes, stereotactically, in each hemisphere into the targeted brain structure under local anesthesia. In a second time (next week): installation of the deep brain neurostimulator and connection to the electrodes implanted under general anesthesia. And one month later: beginning of the stimulation.
16208378|NCT01329120|Procedure|Minimally invasive repair of pectus excavatum|Minimally invasive surgical technique basically consisting of inserting one or more convex steel bars under the sternum through small bilateral incisions in the thoracic wall
16208379|NCT01329120|Procedure|Open surgical repair of pectus carinatum|Open surgical removal the affected cartilages bilaterally and the excess cartilage over the sternum
16208380|NCT01329107|Behavioral|Multimodal Intervention|"Patients in the intervention group will be taught to manage their new urinary diversion BEFORE operation. Traing kit will be provided so they can train the procedure forehanded. Second they will get a personally physical training program to optimize the total body function before operation. Nutritional status will be meassured and appropriate advices will be given BEFORE operation.
~After operation the intervention group will be mobilised in a fast speed compared to standard care."
16208381|NCT01329081|Other|Postoperative rehabilitation after fast-track TKA|Six weeks of strength training combined with patient education
16208382|NCT01329081|Other|Postoperative rehabilitation after fast-track TKA|Six to eight weeks of supervised home training
16208383|NCT01329068|Behavioral|individual consult|regular individual consultations
16208384|NCT01329068|Behavioral|group medical consult|group medical consult
16208385|NCT01329042|Drug|Potassium-sodium citrate|The treated group was given oral potassium-sodium citrate 81 mEq/day The control group received no treatment
16208386|NCT01329029|Drug|Roflumilast|500 µg, once daily
16208387|NCT01329029|Drug|Placebo|once daily
16208388|NCT01329016|Drug|Glyburide|Women with GDM who require treatment will be given glyburide 2.5 mg. Medication will be given at least twice daily and equal doses will be given for each dosing time for the 3 days prior to the pharmacokinetic study day.
16208389|NCT01329016|Drug|Metformin|Women with GDM requiring treatment will be given metformin 500 mg. Medication will be administered at least twice daily and equal doses will be given for each dosing time for the 3 days prior to the pharmacokinetic study day.
16208390|NCT01329016|Drug|Glyburide-Metformin combination|Women with GDM requiring treatment will be given glyburide 2.5 mg with metformin 500 mg. Medications will be administered at least twice daily and equal doses will be given for each dosing time 3 days prior to the pharmacokinetic study day.
16208391|NCT01328990|Drug|sulfadoxine-pyrimethamine plus amodiaquine|one dose of sulfadoxine-pyrimethamine 25/1.25 mg/kg plus three daily doses of amodiaquine, 10 mg/kg/day
16208392|NCT01328977|Behavioral|education|teaching
16208393|NCT01328964|Drug|Fluticasone propionate|fluticasone propionate 44 mcg
16208394|NCT01328964|Drug|Budesonide|budesonide
16208395|NCT01328964|Drug|Montelukast|montelukast
16208396|NCT01328951|Drug|Placebo|Placebo will be administered PO once daily as first-line maintenance until disease progression, death, or unacceptable toxicity.
16208397|NCT01328951|Drug|Erlotinib|Erlotinib will be administered as 150 mg PO once daily until disease progression, death, or unacceptable toxicity, as first-line maintenance or as second-line therapy for those who progress while receiving placebo.
16208398|NCT01328951|Drug|Second-Line Chemotherapy|Participants who progress on first-line maintenance erlotinib may receive an approved second-line therapy (but not EGFR targeted therapies) until disease progression, death, or unacceptable toxicity. The selected chemotherapy will be non-investigational and chosen at the discretion of the Investigator.
16208399|NCT01328938|Biological|GCPGC 3.6mg|Stage I:Single blinded
16208400|NCT01328938|Biological|GCPGC 6mg|Stage I: Single blinded;
16208401|NCT01328938|Biological|Neulasta (pegfilgrastim) 6mg|Stage II: Active comparator, double blinded
16208402|NCT01328938|Biological|GCPGC 6mg|Experimental: Stage II
16208403|NCT01328925|Drug|Nitazoxanide|"Nitazoxanide Oral Suspension dose based on age:
~Age <12 months- 7.5 mg/kg by mouth twice daily for 3 days; Age 12-47 months- 100 mg/5 ml by mouth twice daily for 3 days; Age 48-72 months- 200 mg/10 ml by mouth twice daily for 3 days"
16208404|NCT01328912|Other|Remote ischemic preconditioning stimulus|The intervention will consist of 3 cycles of 5 minutes of upper limb ischemia. The RIPC stimulus will be performed using a blood pressure cuff placed on the upper arm inflated above systemic pressure to 200 mmHg for 5 minutes, then deflated for 5 minutes. Ischemia will be assured with the use of a saturation probe on the digit of the involved arm.
16208405|NCT01328912|Other|control|These patients are randomized to placebo, thus they will no undergo the RIPC stimulus.
16208406|NCT01328899|Device|Lung Volume Reduction Coil (LVRC) (PneumRx's)|Lung Volume Reduction Coil
16208407|NCT01328886|Drug|Omalizumab|omalizumab lyophilized 150 mg injection
16208408|NCT01328873|Other|Microbiological analysis|Bronchoalveolar lavage (BAL) with subsequent testing for pathogens
16208409|NCT01328860|Biological|bone marrow progenitor cells (BMPC) autologous transplantation|Not more than 5ml/kg bone marrow will be collected under anesthesia; after the bone marrow has been processed, about 6-8 hours after bone marrow aspiration, subjects will receive the cells via intra-venous (in the vein) infusion and will be monitored for 24 hours for any adverse events.
16208410|NCT01328834|Drug|Tacrolimus Sustained-release Capsules (ADVAGRAF)|Started: 0.05-0.1mg/kg/d, one time per day, the blood level 5-10ng/ml in the induction treatment.
16208411|NCT01328821|Drug|CTP-499|600 mg, 1200 mg, 1800 mg and 2400 mg
16208412|NCT01328821|Drug|CTP-499|400 mg immediate release capsule
16208413|NCT01328808|Drug|Acetaminophen/APAP|"In preterm and term neonates with a GA of 28 weeks or more a 15 mg/kg dose of APAP will be given every 8 hrs by an intravenous infusion over 30-minute.
~In preterm and term neonates with a GA of less than 28 weeks a 15 mg/kg dose of APAP will be given every 8 hrs by an intravenous infusion over 30-minute"
16208414|NCT01328795|Other|cardiogoniometry|In the course of the project a cardiogoniometry will be carried out during the ambulant or residential hospitalization before the coronary angiography.
16208415|NCT01328782|Drug|Oxycodone with Acetaminophen|0.1- 0.15 mg/kg (oxycodone) every 4-6 hours as needed. Pills: 325 mg acetaminophen: 5 mg oxycodone per tablet. Liquid: 325 mg acetaminophen:5 mg oxycodone per 5 mL.
16208416|NCT01328782|Drug|Bupivacaine 0.25%|"Up to 4 ml at 0.25 % given to .. In toxic doses can lead to irregular heart beat, patients aged 4-7 (dose will be irregular heart rate and cardiac arrest. (This no greater than 0.71 mg/kg)
~Up to 5 ml at 0.25 % by volume solution will be given to patients aged 8-12 (dose will be no greater than 0.63 mg/kg)
~All doses given will be significantly less then maximum allowable dose of 2.5- 3.0 mg/kg"
16208417|NCT01328782|Drug|Ropivacaine 0.20%|"Up to 4 ml at 0.20 % given to patients aged 4-7 (dose will be no greater than 0.57 mg/kg)
~Up to 5 ml at 0.20 % by volume solution will be given to patients aged 8-1(dose will be no greater than 0.50 mg/kg)
~All doses given will be significantly less then maximum allowable dose of 2.5- 3.0 mg/kg"
16208418|NCT01328769|Drug|Febuxostat|
16208419|NCT01328769|Drug|Placebo|
16208420|NCT01328756|Drug|Lisdexamfetamine dimesylate|Optimized dose of either 30, 50 or 70 mg capsule administered once daily for 2 years
16208421|NCT01328743|Behavioral|Brief alcohol intervention|3 sessions of individual face-to-face counseling at baseline, 3 and 6 months. Sessions are motivationally focused including discussion of pros and cons of drinking and feedback on health and its relation to heavy drinking
16208422|NCT01328730|Device|Firebird 2 SES|The FIREBIRD2™ Rapamycin-Eluting CoCr Coronary Stent is the second generation DES of MicroPort, which based on the new cobalt chromium alloy stent platform. It uses polyolefin polymer, which makes the coating property very remarkable.
16208423|NCT01328730|Device|Cypher SES|The Cypher SES is based on the 316L platform with Controlled-release, nonresorbable, elastomeric polymer coating.
16208424|NCT01328717|Device|Contour Link Investigational Blood Glucose Monitoring System|Subjects with diabetes and study staff each performed Blood Glucose tests from the subject's capillary blood obtained from fingerstick using the Contour Link investigational meter.
16208425|NCT01328665|Other|Expressive Writing|Writing intervention for cognitive appraisal of stressor.
16208426|NCT01328652|Drug|dexlansoprazole|dexlansoprazole 60 mg once daily for 3 months
16208427|NCT01328639|Other|TeamCare Depression Intervention|The TeamCare-PCN intervention involves a registered nurse Care Manager (CM), who coordinates collaborative team management for patients with diabetes and depression. The goal of the intervention is to reduce depressive symptoms, achieve targets for cardio-metabolic measures and improve lifestyle behaviours. The intervention includes three phases: (1) managing depression and improving depressive symptoms, (2) managing diabetes and controlling blood glucose, blood pressure and cholesterol, and (3) improving lifestyle behaviours such as healthy eating, physical activity and smoking cessation.
16208428|NCT01328639|Other|Usual diabetes and depression care|Usual care of diabetes and depression involves providing care by the family physician based on usual standards of care and available clinical practice guidelines. Usual care does not involve additional active support from the Care Manager.
16208429|NCT01328626|Drug|ABT-199|Arm A (Cohorts 1-8) and Arm B (Cohort 1-6): Subjects in dose escalation phase will receive 1 dose of ABT-199, followed by 6 days off drug, followed by continuous once daily dosing with ABT-199. Arm B (Cohorts 7+): Subjects in dose escalation phase will receive continuous once daily dosing with ABT-199. Arm A and Arm B: Subjects in expanded safety cohort will receive continuous once daily dosing with ABT-199.
16208430|NCT01328587|Drug|Eltrombopag|Eltrombopag will be administered for 16 to 20 weeks at a starting dose of 150mg/day (East Asian ancestry 75mg /day). The dose will decreased and increased (maximum dose 300mg/day) based on safety and response.
16208431|NCT01328574|Drug|TRC105|15 mg/kg intravenously
16208432|NCT01328548|Drug|Zostavax|
16208433|NCT01328535|Drug|temozolomide|Given PO
16208434|NCT01328535|Other|flow cytometry|Correlative studies
16208435|NCT01328535|Other|staining method|Correlative studies
16208436|NCT01328535|Procedure|biopsy|Optional correlative studies
16208437|NCT01328535|Other|laboratory biomarker analysis|Correlative studies
16208438|NCT01328522|Drug|SAR153191 (REGN88)|"Pharmaceutical form:solution
~Route of administration: subcutaneous"
16208439|NCT01328496|Drug|Preparative Regimen|"Fludarabine (75 mg/m2), fractionated total body irradiation (TBI) (12.0 Gy), and cyclophosphamide (120mg/kg) with mesna. Fludarabine will be given once a day at 25 mg/m2 for three days on day -10 to day -8, TBI will be given twice a day at 150 cGy for four days on day -7 to day -4, and cyclophosphamide will be given once a day for at 60mg/kg for two days on day -3 and day -2.
~Post-transplantation immunosuppression with cyclosporine and MMF will begin on day -3. Cord Blood infusion will occur on day 0 and G-CSF will start on day +1."
16208440|NCT01328483|Procedure|Intrapartum Oropharyngeal Suctioning|After delivery of the head, the infant's mouth and nose were suctioned. Nose was suctioned after the mouth and throat. Oropharyngeal suctioning was performed using a 10 french suction catheter with suction pressure of 100mm Hg or De Lee's suction trap in event of electricity failure or non availability of suction machine
16208441|NCT01328470|Drug|Clopidogrel, cilostazol|Patients with CKD received clopidogrel (75 mg/day)for 14 days Patients with CKD received clopidogrel (150 mg/day)for 14 days Patients with CKD received clopidogrel (75 mg/day)and cilostazol (100 mg twice daily)for 14 days 75mg clopidogrel in patients with normal kidney function for 14 days
16210614|NCT01310998|Behavioral|High intensity exercise|4x4 intervals
16208442|NCT01328457|Drug|Paromomycin sulfate|Paromomycin IM Injection, 11 mg/kg as the base, intramuscular, once a day on 21 consecutive days (or no more than 22 days if one injection is missed during the treatment period).
16208443|NCT01328444|Drug|GSK 573719 +GW642444 125/25|125mcg/ 25mcg
16208444|NCT01328444|Drug|GSK573719 + GW642444 62.5/25|62.5mcg/25mcg
16208445|NCT01328444|Drug|GSK 573719 125|125mcg
16208446|NCT01328444|Drug|GSK 573719 62.5|62.5mcg
16208447|NCT01328444|Drug|GW642444 25|25mcg
16208448|NCT01328444|Drug|Plb|Comparator
16208449|NCT01328431|Other|Brief Intervention with NRT Initiation|Brief Negotiated Interview is a manual-guided therapy designed for the ED setting. The purpose is to assist subjects to change some aspect of their smoking and to decide to start nicotine replacement therapy while in the ED. It combines techniques from motivational interviewing and stages of change. a 6-week supply of nicotine replacement therapy is given in the form of patches and gum and subjects are encouraged to use both concurrently. Patches come in 21 mg, 14 mg, and 7 mg doses and the dosage is determined based on how many cigarettes per day a subject is smoking. All subjects receive 400 pieces of 2 mg nicotine gum. All subjects complete a referral form for the state's Smokers' Quitline which is then faxed directly to the Quitline's vendor.
16208450|NCT01328418|Procedure|Lengthening over nail|External fixator is used to lengthen either the femur or the tibia over an intramedullary nail
16208451|NCT01328405|Device|Laryngeal Mask Airway (LMA)|Comparison of airway seal pressure, airway morbidity bronchoscopic view obtained between two different laryngeal mask airways.
16208452|NCT01328392|Drug|Dexlansoprazole|30mg a day, 3 months
16208453|NCT01328379|Drug|Dalfampridine-ER 5mg|5mg, twice daily
16208454|NCT01328379|Drug|Dalfampridine-ER 10mg|10mg, twice daily
16208455|NCT01328379|Other|Placebo|placebo, twice daily
16208456|NCT01328353|Other|telehealth plus aprn triage|aprn using either telephone or telephone plus video conferencing will provide triage for CCHCN
16208457|NCT01328340|Other|High-speed power training|exercised 3 times per week for 12 weeks. Each training session will consist of 3 sets of 12 to 14 repetitions at 40% of maximal strength
16208458|NCT01328340|Other|Slow-speed strength training|exercised 3 times per week for 12 weeks. Each training session will consist of 3 sets of 8 to 10 repetitions at 80% of maximal strength
16208459|NCT01328301|Other|Experimental|For SDT training, subjects received short intervals of locomotion training with a treadmill. After walking for 30s, the subjects were given two minutes of rest. If they completed the first walking trial safely and without stumbling, the belt speed was increased by 10% on the next trial. However, if a subject failed to complete the first trial, the belt speed was decreased by 10% on the next trial. The speed of the treadmill was adjusted in each subsequent trial according to the same principle. Subjects usually completed 7-8 walking trials in one session. The belt speed was increased by a maximum of five increments within one training session.
16208460|NCT01328301|Other|Speed-stable treadmill training|Subjects in the control group walked on the treadmill with the belt speed adjusted according to their fastest over-ground gait speed. There was no adjustment of the belt speed throughout the 30-minute steady-speed treadmill training session.
16208461|NCT01328288|Drug|standard ART according to the Thai Ministry of Public Health national guidelines|Patients may receive any of the standard regimens. These regimens are recommended in the Thai Ministry of Public Health National guidelines for the treatment of HIV in children. Change of treatment will be according to the treating physicians.
16208462|NCT01328275|Drug|standard regimens according to the Thai Ministry of Public Health national guidelines|Participants may receive any of the standard regimens. These regimens are recommended in the Thai Ministry of Public Health National guidelines for the treatment of HIV in children. Change of treatment will be according to the treating physicians.
16208463|NCT01328262|Other|Calculated red blood cell transfusion|The subjects receive an amount of red blood cells that has been calculated from their body surface area.
16208464|NCT01328262|Other|Standard red blood cell transfusion|The subjects in this group receive the prescribed number of red blood cell units.
16208465|NCT01328249|Drug|eribulin mesylate|Dose dense doxorubicin and cyclophosphamide for 4 cycles during the first 8 weeks followed by eribulin mesylate 1.4mg/m2 for 4 cycles during the next 12 weeks.
16208466|NCT01328236|Drug|Bortezomib|"INDUCTION THERAPY: 1.3 mg/m2, IV (in the vein) on day 1， 4， 8， 11 of each 28 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
~MAINTENANCE THERAPY: 1.3 mg/m2, IV (in the vein) on day 1， 4， 8， 11 of each 28 day cycle. 4 Cycles: interval between every two cycles for 6 months, until progression or unacceptable toxicity develops."
16208467|NCT01328236|Drug|Liposome doxorubicin|INDUCTION THERAPY: 30 mg/m2, IV (in the vein) on day 4 of each 28 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
16208468|NCT01328236|Drug|Dexamethasone|"INDUCTION THERAPY: 40 mg/d, IV (in the vein) on day 1- 4 of each 28 day cycle. 6 Cycles: until progression or unacceptable toxicity develops.
~MAINTENANCE THERAPY: 40 mg/d, IV (in the vein) on day 1- 4 of each 28 day cycle. 4 Cycles: interval between every two cycles for 6 months, until progression or unacceptable toxicity develops."
16208469|NCT01328223|Radiation|sorafenib and radiotherapy for hepatocellular carcinoma|Concurrent and maintenance sorafenib 400mg twice daily
16208470|NCT01328210|Procedure|blood letting|blood letting twice within 4 weeks. First blood removal baseline with 400ml of venous blood and second blood removal with 300-400ml according to serum ferritin levels.
16208471|NCT01328197|Device|Treovance Abdominal Aortic Stent-Graft with Navitel Delivery System|Stent-graft implant
16208472|NCT01328184|Drug|levonorgestrel|multiple doses
16208473|NCT01328184|Drug|levonorgestrel|multiple doses
16208474|NCT01328184|Drug|Ethinylestradiol|multiple doses
16208475|NCT01328184|Drug|Microgynon + BI 10773|multiple doses BI 10773
16208476|NCT01328184|Drug|Ethinylestradiol|multiple doses
16208477|NCT01328171|Drug|FOLFOXIRI + Panitumumab|irinotecan 150 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 3000 mg/m² cont. inf. + panitumumab, iv, 6 mg/kg BW all on day 1 of each 2 weeks cycle until PD or resectability or to max. 12 cycles
16208478|NCT01328171|Drug|FOLFOXIRI|irinotecan 165 mg/m² + oxaliplatin 85 mg/m² + leucovorin 200 mg/m² + 5-FU 3200 mg/m² cont. inf. all on day 1 of each 2 weeks cycle until PD or resectability or to max. 12 cycles
16208479|NCT01328145|Drug|Acetylsalicylic acid|500 mg /day
16211057|NCT01307618|Other|Laboratory Biomarker Analysis|Correlative studies
16208480|NCT01328132|Drug|Saline|100 ml of saline will be given in addition to the standard of care every 8 hours for 24 hours.
16208481|NCT01328132|Drug|25% albumin|100 ml of 25% albumin will be given in addition to the standard of care every 8 hours for 24 hours
16208482|NCT01328119|Other|4-hour HD, 4-hour HDF, 8-hour HD and 8-hour HDF|Prevalent conventional HD (CHD) patients (dialysing 3 days a week during 4 hours per dialysis session) will undergo, in random order, a mid-week 4-hour HD session, a mid-week 4-hour HDF session, a mid-week 8-hour HD session, and a mid-week 8-hour HDF session with a 2-week interval between every session to assess the influence of treatment duration and of convection on the removal of uremic toxins and on the haemodynamic responses and autonomic nervous regulation. In between the study dialysis sessions these patients will receive routine CHD treatments.
16208483|NCT01328106|Drug|GSK1120212|Repeating oral dose
16208484|NCT01328093|Drug|LY2140023|Administered orally
16208485|NCT01328093|Drug|Aripiprazole|Administered orally
16208486|NCT01328080|Radiation|Targeted UV-B|Daavlin Lumera phototherapy device (290-320 nm), dosed by patients' individual minimal erythema dose (MED)
16208487|NCT01328067|Device|Exablate 2100|MRgFUS
16208488|NCT01328067|Procedure|Myomectomy|Non-Hysteroscopic Myomectomy
16208489|NCT01328054|Drug|lapatinib|lapatinib commercial tablet, 2000mg, will be given as three separate doses (8 tablets/dose) given 12 hours apart over a 2 day period
16208490|NCT01328054|Drug|placebo matching lapatinib|placebo matching lapatinib will be given as three separate doses (8 tablets/dose) given 12 hours apart over a 2 day period
16208491|NCT01328041|Drug|dolutegravir|50 mg twice daily
16208492|NCT01328028|Other|Testing of archived cervical cancer tissue samples|Cervical samples will be tested for histopathology diagnosis and human papillomavirus deoxyribonucleic acid testing.
16208493|NCT01328028|Other|Data collection|Log sheet
16208494|NCT01328015|Drug|Oxybutynin 5 mg pills|"½ pill oral 12/12h for 3 days
~01 ½ pills oral morning and evening for 3 days Continue 1 pill oral 2x/day for three weeks."
16208495|NCT01328002|Drug|Milnacipran|"Maximum tolerated dose (50, 75, or 100 mg/day tablets) was determined during the open label phase of the study.
~Oral administration, twice daily dosing"
16208496|NCT01328002|Drug|Placebo|matching placebo tablets daily
16208497|NCT01327989|Device|Solitaire™ FR device|Mechanical Thrombectomy
16208498|NCT01327976|Device|vBloc (Active Device)|Active device will deliver vBloc Therapy
16208499|NCT01327976|Device|Sham (Non-active Device)|Functional non-active control device will deliver no vBloc Therapy
16208500|NCT01327963|Device|Transoral Incisionless Fundoplication|Transoral incisionless esophago-gastric fundoplication performed using the EsophyX (brand name) system with SerosaFuse (brand name) fasteners (EndoGastric Solutions, Inc., Redmond, Washington, USA) and following the standardized Transoral Incisionless Fundoplication 2.0 technique iteration (TIF2.0) protocol.
16208501|NCT01327937|Device|Apligraf|Apligraf group - Applied at Day 0, Weeks 1-4 (maximum of 5 applications) Also cross-over at Week 4 for Control NPTH group - Apligraf applied at Week 4, Weeks 5-8 (maximum of 5 applications)
16208502|NCT01327937|Other|Standard of Care Dressing Group|Standard dressing regimen - Foam dressing (eg, Mepilex) and 4 layered compression system (eg, Profore)
16208503|NCT01327924|Drug|Norditropin NordiFlex®|Daily administration by subcutaneous injection (under the skin). Starting dose and frequency will be determined by the physician as part of normal clinical practice.
16208504|NCT01327911|Biological|NT-501 implant|Ciliary neurotrophic factor (CNTF) implant
16208505|NCT01327898|Behavioral|empowerment theory-based small group discussion|four small group discussion sessions followed by one individual counseling session
16208506|NCT01327898|Behavioral|individual resilience counseling|one individual resilience counseling session
16208507|NCT01327885|Drug|Eribulin mesylate 1.4 mg/m^2 intravenous|Administration of eribulin mesylate at a dose of 1.4 mg/m^2 as an intravenous (IV) bolus infusion over 2-5 minutes on Days 1 and 8 of every cycle, where the duration of each cycle is 21 days.
16208508|NCT01327885|Drug|Dacarbazine of 850 mg/m^2, or 1,000 mg/m^2, or 1,200 mg/m^2 IV|Administration of dacarbazine at a dose of 850 mg/m^2, or 1,000 mg/m^2, or 1,200 mg/m^2 selected by the Principal Investigator [PI] or designee according to the subject's clinical status as an IV infusion over 15-30 minutes on Day 1 of every cycle, where the duration of each cycle is 21 days.
16208509|NCT01327872|Drug|E5501 40 mg 2 x 20-mg tablets, orally, fasted|single 40 mg dose (2 x 20-mg tablets) of Lot P01008ZZA in the fasted condition
16208510|NCT01327872|Drug|E5501 40 mg 2 x 20-mg tablets, orally, with food|single 40 mg dose (2 x 20-mg tablets) of Lot P01008ZZA in the fed condition
16208511|NCT01327872|Drug|E5501 40mg 2 x 20-mg tablets, orally, fasted|single 40 mg dose (2 x 20-mg tablets) of Lot P01009ZZA in the fasted condition
16208512|NCT01327872|Drug|E5501 40 mg 2 x 20-mg tablets, orally, with food|single 40 mg dose (2 x 20-mg tablets) of Lot P01009ZZA in the fed condition
16208513|NCT01327859|Drug|Prior Donepezil 5mg|Received 5 mg donepezil once daily during the preceding double-blind study, E2020-G000-316. Received open-label 5 or 10 mg donepezil during the present study.
16208514|NCT01327859|Drug|Prior Donzepezil 10mg|Received 10 mg donepezil once daily during the preceding double-blind study, E2020-G000-316 . Received open-label 5 or 10 mg donepezil during the present study.
16208515|NCT01327859|Drug|Prior Placebo|Received placebo once daily during the preceding double-blind study, E2020-G000-316. Received open-label 5 or 10 mg donepezil during the present study.
16208516|NCT01327846|Drug|Canakinumab|
16208517|NCT01327846|Drug|Placebo|
16208518|NCT01327846|Drug|Standard of care|Standard of care post-MI background therapy includes, but is not limited to, lipid lowering, anti-hypertensive, beta blockers, and anti-platelet therapy as appropriate
16208519|NCT01327794|Genetic|polymorphism analysis|
16208520|NCT01327794|Other|immunologic technique|
16208521|NCT01327794|Other|laboratory biomarker analysis|
16208522|NCT01327794|Other|medical chart review|
16208523|NCT01327781|Drug|Endoxifen Hydrochloride|Given PO
16208524|NCT01327781|Other|Laboratory Biomarker Analysis|Correlative studies
16208525|NCT01327781|Other|Pharmacological Study|Correlative studies
16208526|NCT01327781|Other|Questionnaire Administration|Ancillary studies
16208527|NCT01327768|Procedure|Olfactory ensheathing cells|Recruited patients should be received the endoscopic surgery for picking the olfactory mucosa 1 to 2 months before transplantation. The OECs will be cultured and expanded under the rule of GTP. Finally, we will transplant the OECs (about 2 to 8 X 10´6 cells in saline) into the peri-infarcted area of the brain for old stroke ischemic patients.
16208528|NCT01327755|Dietary Supplement|Selenium|Selenium yeast containing selenomethionine 200 mcg per day for 2 years
16208529|NCT01327755|Other|Placebo|Same number of pills, frequency, and duration as selenium intervention.
16208530|NCT01327742|Device|Relay Thoracic Stent-Graft|Device implant
16208531|NCT01327729|Drug|pegylated interferon alpha 2a YPEG-IFN α-2a 180mcg|YPEG-IFN α-2a 180mcg dose form: subcutaneous dosage : 180 mcg frequency every week or ten days or 2 weeks according to the group
16208532|NCT01327703|Drug|Panzytrat® 25,000|Panzytrat® 25,000 capsule will be given orally daily at a stabilized dose, as per investigator's discretion, for 14 days. Stabilized dose for a participant will be the optimal dose determined during a qualification phase that precedes the first treatment period and will be based upon the participant's usual lipase and lipid intake. Total dose will not exceed 10,000 European Pharmacopoeia (Ph.Eur.) units lipase/kilogram (kg) body weight/day in either first treatment period or second treatment period.
16208533|NCT01327703|Drug|Kreon® 25,000|Kreon® 25,000 capsule will be given orally daily at a stabilized dose, as per investigator's discretion, for 14 days. Stabilized dose for a participant will be the optimal dose determined during a qualification phase that precedes the first treatment period and will be based upon the participant's usual lipase and lipid intake. Total dose will not exceed 10,000 Ph.Eur. units lipase/kg body weight/day in either first treatment period or second treatment period.
16208534|NCT01327690|Behavioral|CBT (Cognitive Behavior Therapy)|CBT group therapy sessions
16208535|NCT01327690|Behavioral|EFT (Emotional Freedom Techniques)|Group therapy sessions using EFT
16208536|NCT01327677|Drug|Fentanyl|25-50 mcg every 20 minutes
16208537|NCT01327677|Drug|Fentanyl|20mcg/demand dose with an 8 minute lock out
16208538|NCT01327664|Biological|AIN457|
16208539|NCT01327651|Drug|Daily dosing|A fixed-dose combination of emtricitabine and tenofovir disoproxil fumarate.
16208540|NCT01327651|Drug|Time-driven dosing|TDF/FTC twice weekly with a post-exposure dose
16208541|NCT01327651|Drug|Event-driven dosing|TDF/FTC as needed with a post exposure dose
16208542|NCT01327638|Drug|etoricoxib|Patients with SpA/AS who took etoricoxib
16208543|NCT01327638|Drug|Other COX-2 inhibitor|Patients with SpA/AS who took other COX-2 inhibitors
16208544|NCT01327638|Drug|nsNSAIDs|Patients with SpA/AS who took nsNSAIDs
16208545|NCT01327625|Drug|azithromycin + N-acetylcystein + inhaled corticosteroid|"Azithromycin 500mg qd x 1 week --> 250mg qod x 6 months
~N-acetylcystein 200mg tid x 6 months
~Fluticasone 250mcg puff x2/day x 6 months"
16208546|NCT01327612|Drug|Modified FOLFOX6|The mFOLFOX6 regimen is a combination therapy of oxaliplatin 85 mg/m² administered as a 2-hour intravenous (IV) infusion on day 1 and leucovorin 400 mg/m² racemate or 200 mg/m² levo-leucovorin administered as a 2-hour infusion on day 1, followed by a loading dose of 5-fluorouracil (5-FU) 400 mg/m² IV bolus administered on day 1, then 5-FU 2400 mg/m² via ambulatory pump administered for a period of 46 to 48 hours every 14 days.
16208547|NCT01327612|Biological|Conatumumab|Administered by intravenous infusion Q2W or Q3W.
16208548|NCT01327612|Biological|Ganitumab|Administered by intravenous infusion Q3W or Q4W.
16208549|NCT01327612|Biological|Bevacizumab|Administered at a dose of 5 mg/kg by intravenous infusion on day 1 of each 14 day cycle.
16208550|NCT01327599|Drug|Travoprost 0.004%+Timolol 0.5% ophthalmic solution|Fixed dose combination topical ocular agent preserved with polyquaternium-1 (POLYQUAD)
16208551|NCT01327586|Behavioral|ATM|Weekly counseling focused on improving money management, abstaining from cocaine,and minimizing unprotected sex
16208552|NCT01327586|Behavioral|Individual Drug Counseling|Standard individualized drug counseling, modified from that described by Woody and colleagues
16208553|NCT01327573|Drug|eculizumab|"Eculizumab Induction 600mg IV every 7 days for 4 doses
~Eculizumab 900mg IV 7 days later
~Eculizumab Maintenance 900mg IV every 14 days for total of 26 weeks"
16208554|NCT01327547|Drug|Maraviroc|150mg, 300mg or 600mg twice daily x 144 weeks; dosing dependent on components of the current suppressive anti-HIV therapy
16208555|NCT01327547|Drug|Placebo|150mg, 300mg or 600mg twice daily x 144 weeks; dosing dependent on components of the current suppressive anti-HIV therapy
16208556|NCT01327534|Drug|Prasugrel|treatment with a 60 mg loading dose prasugrel, followed by a maintenance dose of 10 mg for 30 days
16208557|NCT01327534|Drug|Clopidogrel|treatment with a 600 mg loading dose clopidogrel, followed by a maintenance dose of 75 mg for 30 days
16208558|NCT01327521|Device|CyberKnife|Standard of Care
16208559|NCT01327521|Procedure|TACE|Standard of Care
16208560|NCT01327521|Drug|CT Contrast|Standard of Care
16208561|NCT01327521|Drug|doxorubicin|Standard of Care
16208562|NCT01327521|Drug|Epirubicin|Standard of Care
16208563|NCT01327521|Drug|5-fluorouracil|Standard of Care
16208564|NCT01327521|Drug|Mitomycin C|Standard of Care
16208565|NCT01327521|Drug|Gemcitabine|Standard of Care
16208566|NCT01327521|Drug|Cisplatin|Standard of Care
16208567|NCT01327521|Device|SMANCS|Standard of Care
16208568|NCT01327508|Device|TRIGEN SURESHOT Distal Targeting Instrumentation.|image-guided localization system
16208569|NCT01327508|Other|Free-hand technique|Free-hand technique utilizes x-rays to find screw holes.
16208570|NCT01327495|Other|placebo acyline|Placebo acyline subcutaneous injection every 2 weeks
16208571|NCT01327495|Other|placebo gel|daily placebo testosterone gel applied transdermally x 12 weeks
16208572|NCT01327495|Drug|Testosterone 1% gel 1.25 g|testosterone 1% gel 1.25 g daily applied transdermally x 12 weeks
16208573|NCT01327495|Drug|Testosterone 1% gel 2.5 g|Testosterone 1% gel 2.5 g daily applied transdermally x 12 weeks
16208574|NCT01327495|Drug|Testosterone 1% gel 5.0 g|Testosterone 1% gel 5.0 g daily applied transdermally x 12 weeks
16208575|NCT01327495|Drug|testosterone 1% gel 10 g|Testosterone 1% gel 10 g daily applied transdermally x 12 weeks
16208576|NCT01327495|Drug|testosterone 1% gel 15 g|Testosterone 1% gel 15 g daily applied transdermally x 12 weeks
16208577|NCT01327495|Drug|Acyline|300 ug/kg subcutaneous injection every 2 weeks
16208578|NCT01327482|Drug|Raltegravir|Dosage: 400mg/PO (by mouth) Frequency: Twice daily Duration: During course of menstrual cycle (28 days)
16208579|NCT01327469|Drug|Albendazole, 2 x 400mg|Albendazole 2 x 400mg
16208580|NCT01327469|Drug|Albendazole 400mg|Albendazole 400mg
16208581|NCT01327469|Drug|Mebendazole 500mg|Mebendazole 500mg
16208582|NCT01327469|Drug|Mebendazole 2 x 500mg|Mebendazole 2 x 500mg
16208583|NCT01327469|Drug|Pyrantel-oxantel + mebendazole|Pyrantel-oxantel + mebendazole
16208584|NCT01327456|Behavioral|Self-Management Intervention|patients will participate in a 1-on-1 interactive intervention, delivered by a trained research assistant targeting self-management skills (e.g. inhaler use, use of an action plan), smoking cessation, and exercise/pulmonary rehabilitation. All participants will return 2-4 weeks after the intervention for a follow-up assessment of inhaler technique use, COPD-related knowledge, and time spent in self-management.
16208585|NCT01327443|Behavioral|Weight loss|Nutritional counseling
16208586|NCT01327443|Behavioral|Exercise|Under direct supervision
16208587|NCT01327430|Dietary Supplement|Milk phospholipid|During day 1 until 10 the subjects were supplemented with daily 3 g milk phospholipids, during the day 11 and 20 the supplementation was increased to daily 6 g, and during the day 21 and 30 the subjects received daily 6 g milk phospholipids and 2 g of plant sterols.
16208588|NCT01327391|Procedure|On line Hemodiafiltration|3 sessions/week; 3-4 hours per session
16208589|NCT01327391|Procedure|Hemodialysis|3 sessions/week; 3-4 hours per session; high flux dialyzers
16208590|NCT01327365|Procedure|trans-radial PCI (TRI)|TRI performed using the sheathless guiding approach
16208591|NCT01327365|Procedure|trans-radial PCI (TRI)|TRI performed using a conventional guiding approach
16208592|NCT01327352|Drug|Oshadi D|oral administration
16208593|NCT01327339|Drug|Ropinirole|Basically there is no treatment allocation. Subjects who would be administered of ropinirole at their physician's direction will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.
16208594|NCT01327326|Drug|Naltrexone|Oral, 50 mg, 1 Time Dose
16208595|NCT01327326|Drug|Placebo|Oral, 1 Time Dose
16208596|NCT01327313|Biological|EMD525797|Subjects will receive 250 milligram (mg) of EMD525797 intravenously every 2 weeks, until progressive disease (PD), unacceptable toxicity or withdrawal of consent.
16208597|NCT01327313|Biological|EMD525797|Subjects will receive 500 mg of EMD525797 intravenously every 2 weeks, until PD or unacceptable toxicity or withdrawal of consent.
16208598|NCT01327313|Biological|EMD525797|Subjects will receive 1000 mg of EMD525797 intravenously every 2 weeks, until PD or unacceptable toxicity or withdrawal of consent.
16208599|NCT01327313|Biological|EMD525797|Subjects will receive 1500 mg of EMD525797 intravenously every 2 weeks, until PD or unacceptable toxicity, or withdrawal of consent.
16208600|NCT01327300|Drug|Mesalamine|Apriso is a 5-ASA drug with Intellicor ™ extended-release delivery technology. A 1.5 gram dosage of Apriso (equaling four 375 mg capsules) once a day will be administered orally for a period of 12 weeks followed by a 3 week wash out prior to crossing over to the placebo arm.
16208601|NCT01327300|Other|Placebo|4 capsules (.375 gm sugar pill capsules) administered orally once a day. This group will receive the placebo for 12 weeks then a wash out for 3 weeks prior to crossing over to the drug arm.
16208602|NCT01327274|Device|Magnetic Mini-Mover Procedure (Magnimplant)|This is a non-randomized study in which otherwise healthy patients, ages 8-14, with severe pectus excavatum (PSI > 3.5) will undergo the Magnetic Mini-Mover procedure outpatient surgery. The Magnimplant or Magnetic Mini-Mover device implant will surgically implanted on the sternum. Patients will be required to wear a custom-fitted orthotic brace, which houses the external magnet and records brace-wear compliance. They will undergo brace treatment for 18-24 months, enough to attempt to improve their PSI (< 3.25). Patients will be seen in clinic at least monthly until treatment is complete and the magnimplant device will be explanted from their sternum.
16208603|NCT01327261|Drug|Levodopa + benserazide|Single oral dose of either Experimental or Active Comparator. Levodopa 200 mg/benserazide 50 mg tablets,with 200 mL of water.
16208604|NCT01327235|Drug|Endostar|intrapleural injection 45 mg; intraperitoneal injection 60 mg, q3d ×3(d1、d4、d7), 3 times as one cycle, at most 2 cycles
16208605|NCT01327235|Drug|Cisplatin|cisplatin 40 mg, q3d ×3(d1、d4、d7), 3 times as one cycle, at most 2 cycles
16208606|NCT01327222|Drug|Bevacizumab|1.25 mg intravitreal bevacizumab
16208607|NCT01327183|Procedure|Percutaneous Coronary Intervention (PCI)|at least 1 hour and up to 24 hours after completion of drug infusion
16208608|NCT01327183|Drug|RO4905417|5 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI
16208609|NCT01327183|Drug|RO4905417|20 mg/kg iv infusion, completed at least 1 hour and up to 24 hours before PCI
16208610|NCT01327183|Drug|placebo|iv infusion, completed at least 1 hour and up to 24 hours before PCI
16208611|NCT01327170|Procedure|Subthreshold diode micropulse laser|
16208612|NCT01327157|Procedure|occlusal adjustment.|It prompted the patient to perform the act of swallowing for 3 times to reach a terminal axis of rotation of the jaw and from this to start. Will be held palpation of the muscles, masseter and temporal on both sides and compared with the marks of carbon found in the teeth. After starts the adjustment following the rules of Guichet with a cylindrical drill with a thin cut . basic principles 1 Occlusive stress maximum distribution in centric relation 2 The occlusive strengths should by the teeth's major axis.3 When the contact is surface to surface, it must be exchanged to another surface point. 4 Once the stability to the centric relation is achieved, it should be kept. The rules to guide the occlusal adjustment selective grinding .
16208613|NCT01327157|Behavioral|Visual analog scale.|"Visual analog scale-Graduation was held on the visual analogue scale in the first and last query to measure discomfort chewing.Graduation was held on the visual analogue scale .in the first and last query to measure discomfort chewing. After graduating dental cleaning was performed, with the purpose of blinding the study, Dental Cleaning.With engine using low speed, brushes, and prophylactic paste is carried out dental cleaning in the teeth of all patient.
~Dental Cleaning.With engine using low speed, brushes, and prophylactic paste is carried out dental cleaning in the teeth of all patient."
16208614|NCT01327144|Drug|Famciclovir|Famciclovir 500 mg- 1 tablet each 12 hours for 7 days
16208615|NCT01327144|Drug|Aciclovir|Aciclovir 400 mg- 02 tablets each 4 hours for 7 days
16208619|NCT01327092|Other|Injury Intervention Group|The hazards identified in the home will be reviewed with the parent and the proposed interventions will be presented. Intervention options are designed and prioritized so that the most passive and durable interventions are recommended first (e.g. self-closing, self-locking stair gate) and progressively less 'passive' and less durable options last (e.g. area gate, pressure mounted gate, or refusal of intervention).
16208620|NCT01327079|Drug|Methadone|"If the infant has been treated with morphine than substitute for that one study dose 0.1 mg morphine with 0.1 mg methadone, whereas if the infant has been treated with fentanyl substitute for that one study dose 1 μg fentanyl with 0.1 mg methadone.
~Administration of inulin:
~Inulin will be administered as a glucose 10%-inulin solution containing 25 gr. inulin/L, at an infusion rate of 0.6 mL/kg/h. After 24 h, the inulin clearance will be calculated."
16208621|NCT01327079|Drug|Methadone|"If the infant has been treated with morphine than substitute for that one study dose 0.1 mg morphine with 0.1 mg methadone, whereas if the infant has been treated with fentanyl substitute for that one study dose 1 μg fentanyl with 0.1 mg methadone.
~Administration of inulin:
~Inulin will be administered as a glucose 10%-inulin solution containing 25 gr. inulin/L, at an infusion rate of 0.6 mL/kg/h. After 24 h, the inulin clearance will be calculated."
16208622|NCT01327066|Drug|Droxidopa|600 mg, single oral dose
16208623|NCT01327066|Drug|Droxidopa|2000 mg, single oral dose
16208624|NCT01327066|Drug|Moxifloxacin|400 mg, single oral dose
16208625|NCT01327066|Drug|Placebo|Placebo matching Droxidopa or Moxifloxacin
16208626|NCT01327053|Drug|LDE225|LDE225 was administered orally, on a continuous once daily dosing schedule and was supplied as 200 mg hard gelatin capsules in bottles. Every 4 weeks on the day of study visit, patients received a prescription of an adequate drug supply for self-administration at home. The 800 mg dose patients received 4 capsules of LDE225 and 200 mg dose arm patients received 1 LDE225 capsule + 3 placebo capsules.
16208627|NCT01327040|Other|light exposure|12-hour light exposure of approximately 200 lux
16208628|NCT01327027|Drug|Vasopressin, Arginine, ADH|Vasopressin will be dissolved in sterile saline and intranasally delivered in one of 2 doses to each subject (20IU, 40IU)
16208629|NCT01327027|Drug|Placebo; Sterile Saline|Sterile saline will be delivered intranasally on a second test day, in counterbalanced order with vasopressin administration.
16208630|NCT01327014|Drug|XueZhiKang (XZK), a botanic product with multiple components|4 capsules of study drug twice a day for 12 weeks.
16208631|NCT01327014|Drug|Placebo|4 capsules twice a day for 12 weeks.
16208632|NCT01326988|Procedure|Real-time ultrasound guided spinal anesthesia|The neuraxial US scan will be performed with the patient in the sitting or lateral position with the hip and knees slightly flexed using full aseptic technique. The spinal needle will be inserted in real-time under direct ultrasound guidance to administer the spinal anesthetic.
16208633|NCT01326962|Drug|tocilizumab [RoActemra/Actemra]|8 mg/kg (max. 800 mg) iv every 4 weeks, 6 infusions
16208634|NCT01326949|Procedure|Transjugular intrahepatic portosystemic shunt (TIPS)|Transjugular intrahepatic portosystemic shunt(TIPS)- TIPS was performed in a conventional fashion or in combination of percutaneous transhepatic or transsplenic approach. Postoperatively, intravenous heparin (8,000-12,000 u/d) for five days, warfarin for six months were given.
16208635|NCT01326949|Procedure|ET+NSBB|"ET-Esophageal varices was treated by endoscopic variceal ligation (EVL). EVL was repeated at intervals of 1-2 weeks until the varices were obliterated or reduced to grade-I size.
~NSBB-Propranolol started at a dose of 20mg twice a day. The dose is adjusted to the maximal tolerated doses to heart rate (HR) of 55 bpm or to decrease the HR 25% from baseline.
~AT-A continuously intravenous infusion of unfractionated heparin followed by oral warfarin is employed. Initially, heparin is administered intravenously for 5 days. Subsequently, oral warfarin is prescribed at the dosage of 2.5 mg/d for 6 months or until complete portal vein recanalization and adjusted to maintain the INR at a target of 2.5 (range 2.0-3.0)."
16208636|NCT01326936|Behavioral|Online education|A brief (2-hour) interactive online training program in substance abuse (SU) management using virtual patient (VP) technology. Each learner will take one of two similar online programs involving five VPs that represent the range of SU management issues that commonly arise in clinical practice.
16208637|NCT01326923|Drug|Cetuximab|Single arm phase II study of chemotherapy
16208638|NCT01326910|Drug|Colloidal Oatmeal|Topical cream applied twice daily (or as needed)
16208639|NCT01326910|Device|Topical Cream|Topical cream applied twice daily (or as needed)
16208640|NCT01326897|Behavioral|Healthy Homes/Healthy Families|"Participants in the intervention group will work with coaches to make their homes more supportive of healthy eating and physical activity. Each intervention participant will receive a tailored home environment profile, and will select from a menu of healthy actions to make changes in their home. The intervention will be delivered over the course of 5 months, with 3 home visits, 4 coaching calls, and 4 support mailings."
16208641|NCT01326897|Behavioral|Health Education|Study participants in this group will receive health education materials by mail (3 times over the course of 5 months).
16208642|NCT01326884|Device|ZLP|ZLP Graft
16208643|NCT01326871|Drug|Cisplatin|Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 1 of each course (if given)
16208644|NCT01326871|Drug|Gemcitabine|Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II); on day 1 and 8 of each course
16208645|NCT01326871|Biological|ALT-801|Intravenous infusion; 3 initial treatment courses and an additional 3 maintenance courses for responders (maintenance revised for Phase II): on day 3, 5, 8, and 12 of each course
16208646|NCT01326858|Drug|Olopatadine hydrochloride ophthalmic solution, 0.7%|Treatment A
16208647|NCT01326858|Drug|Olopatadine hydrochloride ophthalmic solution vehicle|Treatment B, inactive ingredients used as placebo
16208648|NCT01326858|Drug|Ketotifen fumarate ophthalmic solution, 0.025%|Treatment C
16208649|NCT01326845|Drug|Deferasirox|
16208650|NCT01326832|Device|Primoris|Total hip arthroplasty with the new Primoris femoral component
16208686|NCT01326546|Other|placebo|Inject placebo 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.
16208687|NCT01326533|Drug|hydroxychloroquine|Thirteen weeks of oral hydroxychloroquine (400 mg/day) provided as capsules
16208688|NCT01326533|Other|Placebo|Thirteen weeks of oral placebo provided as capsules
16208651|NCT01326806|Behavioral|Families Talking Together|The intervention will take place in a pediatric health care clinic and will be coordinated through provider extenders when healthcare providers see youth fora non-acute care visit. A mother of the adolescent will meet with a provider extender for approximately 30 minutes while her child is being examined by a healthcare provider. During this time, the intervention will be delivered to the mother. At the conclusion of the session, the mother will be given reference materials to take home and tasks to perform to facilitate discussions about sex with her adolescent. The healthcare provider will endorse the intervention separately for mothers and adolescents. There will be one follow-up booster session administered through phone calls to increase completion probabilities of the tasks. The target behavior is sexual activity in adolescents.
16208652|NCT01326806|Behavioral|Active Control on Hygiene & Nutrition|The active control group will take place in a pediatric health care clinic and will be coordinated through provider extenders when healthcare providers see youth for a non-acute care visit. The mother of the adolescent will meet with a provider extender for approximately 30 minutes while her child is being examined by a healthcare provider. During this time, the active control on hygiene and nutrition will be delivered to the mother.
16208653|NCT01326793|Other|Skype Consultation|One-hour Skype consultation with MA-licensed psychiatrist and a written summary of findings.
16208654|NCT01326780|Drug|1.2% JNJ 10229570-AAA|1.2% JNJ 10229570-AAA 1.2% cream applied once daily to the face for 12 weeks
16208655|NCT01326780|Drug|2.4% JNJ 10229570-AAA|2.4% JNJ 10229570-AAA 2.4% cream applied once daily to the face for 12 weeks
16208656|NCT01326780|Drug|3.6% JNJ 10229570-AAA|3.6% JNJ 10229570-AAA 3.6% cream applied once daily to the face for 12 weeks
16208657|NCT01326780|Other|Vehicle control|Color matched cream vehicle, applied once daily to the face for 12 weeks
16208658|NCT01326767|Drug|Paclitaxel dosing according to SmPC|Paclitaxel i.V. Up to 6 cycles Dosing according to SmPC
16208659|NCT01326767|Drug|Individualized pharmacokinetically driven paclitaxel dosing|Paclitaxel i.V. Up to 6 cycles Dosing based on patient age, gender, severity of neutropenia and Paclitaxel plasma concentration
16208660|NCT01326754|Drug|Artemether-lumefantrine combination|Dispersible formulation of artemether-lumefantrine at a dose of 2/12 mg/kg body weight of artemether and lumefantrine, respectively, per dose, given twice a day for 3 days
16208661|NCT01326754|Drug|Artesunate-amodiaquine combination|Co-formulated artesunate-amodiaquine at a dose of 4 mg/kg/day artesunate and 10 mg/kg/day amodiaquine once a day for 3 days
16208662|NCT01326754|Drug|Dihydroartemisinin-piperaquine|Co-formulated dihydroartemisinin-piperaquine at a dose of 4 mg/kg/day dihydroartemisinin and 18 mg/kg/day piperaquine once a day for 3 days
16208663|NCT01326728|Biological|Allogeneic stem cell transplant|Donors will undergo cell collection and recipients will receive cells (allotransplant).
16208665|NCT01326702|Drug|Bendamustine Hydrochloride|Given IV
16208666|NCT01326702|Other|Pharmacological Study|Correlative studies
16208667|NCT01326702|Biological|Rituximab|Given IV
16208668|NCT01326702|Drug|Veliparib|Given PO
16208669|NCT01326689|Drug|KW-2246|Rescue medication at an optimal dose, which is determined by dose titration
16208670|NCT01326689|Drug|Placebo|
16208671|NCT01326676|Drug|Polypill: Red Heart Pill|"The polypill will be taken once/day in the form of a hard capsule, to be taken orally. There are two versions of the polypill (Red Heart Pill):
~Version 1 contains aspirin 75mg, simvastatin 40mg, Lisinopril 10mg and Atenolol 50mg; Version 2 contains aspirin 75mg, simvastatin 40mg, Lisinopril 10mg and Hydrochlorothiazide 12.5mg.
~Red Heart Pill Version 1 and Red Heart Pill Version 2. In general, participants with a history of coronary heart disease will be given version 1, and those with a history of stroke or cerebrovascular disease will be given version 2."
16208672|NCT01326676|Drug|Usual medication|Participants in the 'Usual Care' arm will continue to take the separate, individual medications prescribed by their usual doctor, e.g. aspirin, blood pressure lowering drugs, statins.
16208673|NCT01326663|Drug|Medication Trial|
16208674|NCT01326650|Drug|Vitamin D|daily oral vitamin D supplement of 100 micrograms for three years
16208675|NCT01326650|Drug|placebo|daily oral placebo supplement for three years
16208676|NCT01326637|Other|Patient Overview Document|"The Intervention has two components:
~Pre-visit care coordination:
~5-7 days prior to a study patient's appointment with the doctor, the doctor's nurse/MA will call the study patient and collect pertinent clinical information using a data collection form we call a Patient Overview Document or POD. The purpose of the POD is to comprehensively inform the doctor about the patient before the doctor enters the exam room.
~The nurse/MA will ensure that lab results, consultant reports, ER reports, imaging studies, etc., needed by the physician during the patient's visit, are available to the doctor in their usual place.
~Team Meeting:
~On the day of the patient's appointment, prior to the beginning of the clinic session, the nurse/MA and doctor will jointly review the POD."
16208677|NCT01326624|Device|wearable defibrillator (LifeVest)|LifeVest wearable defibrillator for unattended treatment of sudden cardiac arrest due to ventricular tachycardia or ventricular fibrillation
16208678|NCT01326611|Drug|Clarithromycin|
16208679|NCT01326611|Drug|Dextrose|
16208680|NCT01326598|Device|V-Go™|Use of Insulin Delivery Device, V-Go, and the effect on A1C for T2DM patients in five categories of baseline oral antidiabetes drug (OAD) use with or without insulin.
16208681|NCT01326585|Drug|Dexamethasone Sodium Phosphate Injection|8mg (2cc of 4mg/mL solution), IV solution, 1-time dose during surgery
16208682|NCT01326585|Drug|Saline Injection|2cc of 0.9% normal saline, IV injection, 1-time dose during surgery
16208683|NCT01326559|Drug|Docetaxel, Cisplatin, 5-FU and Cetuximab|"Induction phase (Weeks 1-9):
~Drug Docetaxel Docetaxel 75 mg/m2 IV, D1 every 3 weeks for 3 cycles
~Drug Cisplatin Cisplatin 75 mg/m2 IV, D1 every 3 weeks for 3 cycles
~Drug Fluorouracil Fluorouracil 750 mg/m2 IV, D1-4 every 3 weeks for 3 cycles
~Concurrent phase (weeks 10-16):
~Drug Docetaxel Docetaxel 15 mg/m2 IV, D1 weekly for 7 weeks (Weeks 10-16)
~Drug Cetuximab Cetuximab 400 mg m2 IV, D1 initial dose, then 250 mg/m2 weekly for 7 week (Weeks 10-16)
~IMRT (60 Gy to GTV or biological dose equivalent): 2 Gy/fraction/day, D1-5 per week, for 6 weeks (Weeks 11-16)"
16208684|NCT01326546|Biological|Therapeutic HBV vaccine|Inject εPA-44 900μg at week 0, 3, 6, 9, 12, 15, 18, 21, 24, 28, 32, 36, 40, 44, 48.
16208685|NCT01326546|Drug|entecavir|0.5mg,per day,oral intake.
16208689|NCT01326520|Dietary Supplement|milk phospholipid|The patients will consume daily 250 mL of a dairy product, which is enriched with 3 g of milk phospholipids.
16208690|NCT01326520|Dietary Supplement|diary product|The patients will consume daily 250 mL of a common dairy product.
16208691|NCT01326507|Biological|Dosage de l'h-FABP|Dosage de l'h-FABP
16208692|NCT01326494|Drug|Arm 1 Oral Cortico Steroids|"Prednisolone: 1 mg / kg per day course of dose for 5 days up to child's weight of 20 kgs.
~Dexamethasone: 0.3mg/kg per dose for 3 days (minimum weight 20 kgs )"
16208693|NCT01326481|Drug|TRC105|IV
16208694|NCT01326481|Drug|Capecitabine|oral
16208695|NCT01326468|Drug|Temsirolimus|All patients will receive temsirolimus. The dose of temsirolimus in this study will range from 15-25 mg depending on the dose level. Temsirolimus will be infused over a 30-60 minute period once a week for the duration of radiation therapy.
16208696|NCT01326468|Drug|Cetuximab|"All patients will receive cetuximab. An initial loading dose of cetuximab 400 mg/m2, intravenously over 120 minutes at least 4 days before radiation therapy but no more than 7 days before the start of radiation therapy.
~Thereafter, cetuximab will be infused at 250 mg/m2 dose over 60 minutes weekly for the duration of radiation therapy."
16208697|NCT01326468|Drug|Cisplatin|All patients in Cohort A will receive cisplatin. The dose will be 20 mg/m2 or 30 mg/m2 depending upon the dose level.
16208698|NCT01326468|Device|Radiation Therapy|Patients will be treated on a linear accelerator fitted with multi-leaf collimators with 1.6-2.3 Gy fractions delivered daily 5 days per week over 4-7 weeks to a cumulative dose of 66 Gy. A variance of +/- 10% in this nominal prescription dose is allowable and will depend on the extent of residual disease, at the discretion of the attending radiation oncologist.
16208699|NCT01326455|Device|Terumo TR wristband|
16208700|NCT01326455|Device|Terumo TR wristband|
16208701|NCT01326455|Device|Clo-Sur-P.A.D.|
16208702|NCT01326442|Other|low glycemic diet|a low glycemic diet, calorie restricted with exercise sessions 3 times per week
16208703|NCT01326442|Dietary Supplement|vitamin D omega-3|2000 IU vitamin D3 plus 1.8 g EPA + DHA per day for 16 weeks.
16208704|NCT01326416|Dietary Supplement|L-Leucine and L-arginine|Specific nutritional supplementation for six months by 30g per day of a mixture of amino acids (21 g L-Leucine and 9 g of L-arginine), to be distributed during each of the 3 main meals.
16208705|NCT01326416|Other|Physical Reconditioning by a trainer|Physical reconditioning sessions begin with a warm-up for five minutes for the type of effort made, and then correspond to a sporting course composed of elements of strength training and / or aerobic exercises and will be completed by a return to simple stretching and general advice on managing their physical life. The duration of each session will be 45 minutes at the beginning of the protocol and then gradually increased over time to achieve 1:30 of total physical activity at the end of protocol.
16208706|NCT01326403|Drug|Tranexamic acid|"GROUP A - receive IV Tranexamic acid 1 gram upon diagnosis and consent in the emergency room. A second 1 gram in a slow drip during the next 8 hours.
~GROUP B - IV Tranexamic acid 1 gram five minutes before skin incision and a second 1 gram in a slow drip during the next 8 hours.
~Group C - A control group will only receive placebo in the emergency room and in the OR."
16208707|NCT01326390|Device|dTA/dBA C-arm fluoroscopy system with Dyna CT|C-arm CT of the liver; state-of-the-art flat panel detector on a ceiling or floor mounted C-arm gantry
16208708|NCT01326390|Procedure|DSA arteriogram- hepatic arteries|Standard of care
16208709|NCT01326390|Procedure|CO2 aortogram|Standard of care
16208710|NCT01326364|Procedure|Stereotactic body radiotherapy|Standard of Care
16208711|NCT01326364|Drug|Iodixanol|IV, calculated per patient
16208712|NCT01326364|Drug|Iohexol|IV, Calculated per patient
16208713|NCT01326351|Procedure|Regenerative injection therapy|Injection of 10cc of a 15% dextrose and 0.6% lidocaine solution free of epinephrine in one injection site (lateral infiltration of the plantar fascia). This injection will be performed following posterior tibial nerve blockade (injection of 10cc of 1% lidocaine and 0.25% bupivacaine solution free of epinephrine behind the posterior tibial artery). The intervention will be administered every three weeks until symptoms are alleviated for a maximum of 5 injection sessions. Furthermore, patients must perform an at-home exercise program 3 times a week for a total of 12 weeks. The exercise program consists of 3 stretching exercises, 1 muscle release exercise and 1 strengthening exercise.
16208714|NCT01326351|Procedure|Dry needle injection|Injection of dry needle in one injection site (lateral infiltration of the plantar fascia). This injection will be performed following posterior tibial nerve blockade(injection of 10cc of 1% lidocaine and 0.25% bupivacaine solution free of epinephrine behind the posterior tibial artery). The intervention will be administered every three weeks until symptoms are alleviated for a maximum of 5 injection sessions. Furthermore, patients must perform an at-home exercise program 3 times a week for a total of 12 weeks. The exercise program consists of 3 stretching exercises, 1 muscle release exercise and 1 strengthening exercise.
16208715|NCT01326351|Behavioral|Exercise|At-home exercise program that patients must perform 3 times a week for a total of 12 weeks. The exercise program consists of 3 stretching exercises, 1 muscle release exercise and 1 strengthening exercise.
16208716|NCT01326338|Drug|Nitazoxanide|Nitazoxanide Oral Suspension 100 mg/5 ml for patients aged 1-3 years twice daily for 3 days or Nitazoxanide Oral Suspension 200 mg/10 ml for patients aged 4-11 years twice daily for 3 days
16208717|NCT01326325|Drug|Ketamine|Drip continues of ketamine in intravenous injection included posology enters 0,5mg/kg /day and 2mg/kg/day during 4 days
16208718|NCT01326325|Drug|NaCl|Drip continues of NaCl 0,9% in intravenous injection during 4 days
16208719|NCT01326312|Drug|GTx-758|comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
16208720|NCT01326312|Drug|Lupron Depot|comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
16208721|NCT01326312|Drug|GTx-758|comparison of different dosages of GTx-758 with leuprolide acetate for depot suspension
16208722|NCT01326299|Other|Carbohydrate placebo|dissolve in water and consume with meal
16208723|NCT01326299|Other|Nutritional ingredient|Dissolve in water and consume with meals
16208724|NCT01326299|Other|#1 Nutritional ingredient +Fiber|Dissolve in water and consume with meal
16208725|NCT01326299|Other|#2 Nutritional ingredient + Fiber|Dissolve in water and consume with meal
16208726|NCT01326299|Other|#3 Nutritional ingredient + Fiber|Dissolve in water and consume with meal
16208727|NCT01326273|Procedure|Lymphopheresis|Lymphopheresis
16208728|NCT01326273|Procedure|CMV specific lymphocyte infusion|CMV specific lymphocyte infusion
16208729|NCT01326273|Procedure|Peripheral blood for CMV DNA PCR|Peripheral blood for CMV DNA PCR
16208730|NCT01326273|Procedure|Haematology/Blood chemistry|Haematology/Blood chemistry analysis, Collection of blood for ancillary laboratory tests.
16208731|NCT01326247|Other|thermal waters nasal irrigation|"The first group (group 1) has practiced crenotherapy with hyper-mineral chloride sodium water aerosol by nasal adapter for 15 days per month, for three consecutive months, at thermal spa services of Lacco Ameno, while the control group (group 2) was treated, in the same period, daily, by a micronized nasal douche with 0.9% NaCl (isotonic) solution."
16208732|NCT01326234|Behavioral|Personalized Feedback|The interactive program will provide assessment and personalized feedback on the participants' level of nicotine dependence, daily cigarette consumption, money spent on cigarettes, behavioral consequences of smoking, individual medical consequences of smoking, and family members' medical consequences of secondhand smoke.
16208733|NCT01326234|Behavioral|Treatment as Usual|Practitioners are able to provide normal care with regard to smoking; participants will complete the Treatment Fidelity Questionnaire to assess whether any smoking cessation interventions occurred
16208734|NCT01326221|Drug|tenofovir + emtricitabine|tenofovir 300mg + emtricitabine 200mg x one dose
16208735|NCT01326208|Procedure|PEEP titration|PEEP is set according to the following protocols, respectively, in a randomized order: ARDSnet table, Open Lung strategy, guided by EIT
16208736|NCT01326195|Behavioral|Cognitive-Behavioral Dating Violence and HIV Prevention Group|Six, two-hour weekly sessions and one 2-hour booster session 6 weeks later with adolescent females
16208737|NCT01326195|Behavioral|Psycho-educational Dating Violence and HIV prevention group|Knowledge based intervention matched for time and attention to skills arm
16208738|NCT01326182|Behavioral|MAADRE|Group-based intervention combining asthma education and CBT for depressive symptoms
16208739|NCT01326182|Behavioral|MAAS|Group-based intervention including asthma education and education regarding general child health
16208740|NCT01326169|Behavioral|Brief intervention|Telephone-delivered counseling
16208741|NCT01326169|Behavioral|Standard care|No intervention
16208742|NCT01326156|Device|Knee arthroplasty|Comparison of patellofemoral arthroplasty versus conventional total knee arthroplasty in cases of isolated patellofemoral osteoarthritis.
16208743|NCT01326143|Device|ORM Narval MRD|
16208744|NCT01326130|Behavioral|Chronic care management 1-6|1- an interdisciplinary team in an education center working with primary care physicians and offering to referred patients a pre-determined sequence of clinical interventions over a 2-year-period; 2- a program supporting primary care physicians (continuing education, documentation and clinical guidelines, referral system to second line of care); 3- networking between actors insuring clinical information transfer required for efficient patient management.
16208745|NCT01326117|Drug|tadalafil|7 days of Cialis for Daily Use (5mg)
16208746|NCT01326104|Biological|TTRNA-xALT|TTRNA-xALT 3 x 10^7/kg by intravenous injection once.
16208747|NCT01326104|Biological|TTRNA-DCs|TTRNA-DCs 1 x 10^7 by intradermal injection every 2 weeks for 3 total doses.
16208748|NCT01326091|Other|Hyperlordotic Positioning|Hyperlordotic positioning will be achieved through pelvic pads positioned low on iliac crest to maximize lumbar hyperlordosis and increased hip flexion with as many pillows as tolerated at thighs and knees to allow for increased sacral slope. Regular position will involve the pelvic pads at above or iliac crest and without extra pillows at thighs and legs.
16208749|NCT01326078|Drug|propofol|3 - 4 mg/kg IV, adjustment dose if necessary
16208750|NCT01326052|Procedure|Inferior Mesenteric Artery Preservation|Performing left hemicolectomy the IMA was preserved ligating close to the colonic wall the sigmoids arteries.
16208751|NCT01326052|Procedure|Inferior Mesenteric Artery Ligation|Performing left hemicolectomy the IMA is ligated and sectioned after the origin of left colic artery
16208752|NCT01326039|Drug|bupivacaine|perineural bupivacaine 5 mg/ml 20 ml
16208753|NCT01326039|Drug|saline|perineural isotonic saline 20 ml
16208754|NCT01326026|Drug|insulin degludec|Injected subcutaneously (under the skin) once daily. Dose individually adjusted.
16208755|NCT01326026|Drug|insulin degludec|Injected subcutaneously (under the skin) once daily. Dose individually adjusted in a stepwise manner.
16208756|NCT01326000|Drug|FOLFIRI|standard iv chemotherapy
16208757|NCT01326000|Drug|RO5083945|1400 mg iv on Day 1 and Day 8, and every 2 weeks thereafter
16208758|NCT01326000|Drug|cetuximab|400 mg/m2 iv on Day 1, followed by 250 mg/m2 iv every week
16208759|NCT01325987|Dietary Supplement|Vitamin D2|Subjects with vitamin D deficiency (serum 25(OH)D <20ng/ml) will receive an 8 week of vitamin D treatment (50,000 IU oral vitamin D2/once per week) vs. placebo. All subjects will continue their existing hypoglycemic regimen.
16208760|NCT01325987|Other|Sugar pill|"group: vitamin D2 50000 IU weekly once for 8 weeks
~nd group: placebo weekly once for 8 weeks"
16208761|NCT01325961|Radiation|Intensity-Modulated Radiation Therapy|
16208762|NCT01325935|Drug|Clopidogrel|DAPT using aspirin 81 mg/day (minimal dose) and clopidogrel 75 mg/day should be conducted for 3 months (+ 30 days) after stenting.
16208763|NCT01325922|Procedure|DFT Testing with a 50/50% tilt|
16208764|NCT01325909|Behavioral|Exercise programme|
16208765|NCT01325896|Drug|PEG-Intron sc injection|"This program is only open to patients with multiple myeloma who have achieved a complete or partial response after a myelosuppressive chemotherapy regimen followed by autologous stem cell infusion of peripheral blood transplant (PBSCT) as treatment intensification. These patients will be treated with PEG-Intron as maintenance therapy, to be permitted during the same concomitant administration of corticosteroids and / or bisphosphonates.
~PEG-Intron: 35 mcg per week by subcutaneous injection to progression or recurrence of the disease, or for 5 years maximum.
~Patients were administered PEG-Intron to a uniform dose of 15 mg initial week for 2 weeks. If this dose is tolerated, it would be gradually increased to 25 mg and then to 35 mg every 2 weeks, assuming that there is no toxicity of grade 3 or worse."
16208766|NCT01325870|Device|ACD-CPR|
16208767|NCT01325870|Device|ITPR|standard CPR with use of the CirQlator intrathoracic pressure regulator (ITPR)
16208768|NCT01325870|Procedure|S-CPR|standard manual CPR
16208769|NCT01325870|Device|Impedance Threshold Device (ITD)|
16209068|NCT01323634|Drug|Fluticasone Furoate 100mcg / GW642444 (vilanterol) 25mcg|inhalation powder
16208770|NCT01325857|Procedure|Bilateral superficial cervical plexus block|Bilateral superficial cervical plexus block with 0.525% ropivacaine 20ml
16208771|NCT01325857|Procedure|placebo|Procedure: Bilateral superficial cervical plexus block with normal saline 20ml
16208772|NCT01325857|Procedure|Control group|Procedure: Local anesthetic infiltration at incision site with 0.525% ropivacaine 20ml
16208773|NCT01325844|Procedure|Epidural anesthesia|0.5% ropivacaine infusion via epidural catheter at 5ml/hr during general anesthesia
16208774|NCT01325831|Device|repetitive transcranial magnetic stimulation(rTMS)|10-day course of 10 Hz rTMS on left dorsolateral prefrontal cortex of the subjects.
16208775|NCT01325831|Device|Sham repetitive transcranial magnetic stimulation(rTMS)|Sham repetitive transcranial magnetic stimulation(rTMS)
16208776|NCT01325818|Drug|pravastatin, rosuvastatin|"Active Comparator Intervention: Drug: pravastatin 10mg/day or 20mg/day
~Active Comparator Intervention: Drug: rosuvastatin 20mg/day"
16208777|NCT01325805|Behavioral|Structured Weight Loss Program|Those patients randomized to the structured weight loss group will have a formal evaluation and counseling a medical endocrinologist specializing in weight management. The structured weight loss program will consist of meeting with a dietician who will guide them on following a hypocaloric diet with a calorie deficit of 750kcal/day. The weight loss goal will be to lose 1-1.5 pounds/week. The participants will receive teaching utilizing the American Diabetes Association Exchange Lists and will receive sample meal plans. In addition, participants will be seen by the dietitian once a week for a month, then every 2 weeks for 2 months, then once per month for 3 months. Patients randomized to the study group will continue in the structured weight loss program for 6 months.
16208778|NCT01325805|Behavioral|Routine Weight Loss Counseling|Participants randomized to the routine weight loss counseling group will receive the ACOG Patient Education pamphlets on obesity.
16208779|NCT01325792|Device|GORE® BIO-A® Tissue Reinforcement|Retrorectus or intraperitoneal placement of device to reinforce the midline fascial closure after single-staged open complex ventral incisional hernia repair of primary or recurrent anterior abdominal wall hernia.
16208780|NCT01325779|Drug|heparin|subcutaneous heparin 5000 units every 8 hours
16208781|NCT01325779|Drug|enoxaparin|subcutaneous enoxaparin 40 milligrams every 24 hours
16208782|NCT01325766|Other|Yoga|Yoga 2 sessions per week for 8 weeks
16208783|NCT01325753|Procedure|cryotherapy|Undergo CT-guided CA
16208784|NCT01325753|Procedure|quality-of-life assessment|Ancillary studies
16208785|NCT01325740|Drug|STX107|STX107 10 mg single dose po capsule, STX107 30 mg single dose po capsule, Placebo single po capsule
16208786|NCT01325727|Other|Brief computerized feedback|Brief computerized feedback
16208787|NCT01325727|Other|Resources only (control)|Participants randomized to the control group will discuss the option of quitting smoking, along with an information sheet, highlighting resources available to assist participants with smoking cessation, such as the Virginia Quitline (1-800 QUIT NOW) and nicotine replacement therapy.
16208788|NCT01325714|Behavioral|PAVeD Intervention|In the PAVeD Intervention, the caregiver will receive six to eight 45-minute visits to teach caregiver about pain and memory problems. The person with dementia will also be able to learn from these visits. These visits will take place over three months.
16208789|NCT01325714|Behavioral|Enhanced Usual Care|"In Enhanced Usual Care, the caregiver will receive information in the mail about memory problems and pain; and the caregiver will receive eight short telephone calls to check on how the person with dementia is doing.
~Primary Care providers will be notified through electronic medical records about any significant behavioral problems or pain."
16208790|NCT01325701|Drug|ibrutinib|ibrutinib is an inhibitor of BTK
16208791|NCT01325688|Drug|PEP005 (ingenol mebutate) Gel, 0.05%|PEP005 (ingenol mebutate) Gel, 0.05% for up to three consecutive days
16208792|NCT01325688|Device|Aluminium disk|
16208793|NCT01325688|Device|OpSite(TM) disk|
16208794|NCT01325675|Behavioral|Interval training|Aerobic interval training will be performed with 4 times of 4 minutes intervals at an intensity of 90-95% of maximum heart rate and active pauses of 3 minutes between intervals. 3 times a week for 12 weeks.
16208795|NCT01325649|Procedure|total mesorectal excision / long course radiochemotherapy|long course 5-FU based radiochemotherapy before total mesorectal excision
16208796|NCT01325649|Radiation|long course 5-FU bases radiochemotherapy|
16208797|NCT01325636|Other|Cell therapy|"Injection of specific T cell by intravenous way with a posology of 1000 to 5000 CD3 IFN γ+ / kg.
~A second injection could be made at day 21"
16208798|NCT01325623|Device|Model 106 VNS Therapy System|The VNS Therapy System is an adjunctive therapy for the treatment of epilepsy. VNS Therapy is available as a scheduled stimulation, this is cyclic stimulation between programmable On- and Off- times (e.g., a 30-second burst every 5 minutes). VNS Therapy is also available as on-demand stimulation, that is, when a magnet is introduced briefly over the implanted device (Magnet Mode). The AspireSR VNS Therapy System includes a new feature, Automatic Magnet Mode or AutoStim. In addition to Normal Mode and Magnet Mode, AspireSR uses a Seizure Detection Algorithm to identify a potential seizure onset based on associated heart rate increases known as ictal tachycardia. The purpose is to deliver stimulation at or near the onset of a seizure.
16208799|NCT01325610|Dietary Supplement|cholecalciferol|a weekly dose of 20,000 IU of vitamin D3 will be given orally for 12 weeks.
16208800|NCT01325597|Other|Combined training|FES will be applied at 15 Hz, 0.4 ms pulse width, 10-s contraction time, 50-s resting time and maximum tolerable intensity, 3 sessions per week, for 12 weeks. The IMT will also be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure.
16208801|NCT01325597|Other|Electrical stimulation|FES will be applied at 15 Hz, 0.4 ms pulse width, 10-s contraction time, 50-s resting time and maximum tolerable intensity, 3 sessions per week, for 12 weeks
16208802|NCT01325597|Other|Inspiratory muscle training|IMT will be performed for 12 weeks, 5 sessions per week, with an intensity of 30% of maximal inspiratory pressure
16208803|NCT01325597|Other|Control group|No intervention
16208849|NCT01325298|Drug|Riboflavin|Riboflavin 0.1% is applied to the cornea every 2 minutes for 14 minutes prior to and also during UV-X Light treatment.
16208850|NCT01325298|Device|UV-X Light|UV-X 365 nm wavelength light source is applied to the cornea with continued application of riboflavin 0.1%
16208851|NCT01325298|Drug|Riboflavin|Riboflavin 0.1% is applied to the cornea every 2 minutes for 14 minutes prior to and also during UV-X Light treatment.
16208804|NCT01325584|Drug|Omegaven|initial dose of 0.1 g/kg body weight (1ml/kg) and increased to 0.2 g/kg body weight (2ml/kg) on day 2 or 3 of treatment. The infusion rate will not exceed 0.5mL Omegaven/kg body weight/hr (corresponding to 0.05g fish oil/kg/hr). Patients will receive the initial infusion of PN containing Omegaven at Midwestern Regional Medical Center (MRMC) in the infusion center to observe for adverse reactions. Patients will continue to receive infusions at MRMC for the first 2 to 3 days of dosing. After tolerance is established, patients will receive treatment at home. All study patients will have a Screening Visit; Day 1, Day 2 and Day 3 visits; and weekly visits for one month.
16208805|NCT01325571|Drug|Tacrolimus capsule|oral
16208806|NCT01325571|Drug|Placebo|oral
16208807|NCT01325558|Biological|ALT-836 in combination with gemcitabine|Study participants will receive up to four courses of a 28-day biochemotherapy with the study drug (ALT-836) and gemcitabine. Each treatment course consists of five doses of ALT-836 (on Day 1, 4, 8, 15 and 22) and three doses of gemcitabine (Day 1, 8 and 15). Participants with persistent responses will receive additional two cycles, three doses each, of standard of care gemcitabine therapy.
16208808|NCT01325545|Other|Mobile cardiac rhythm monitoring|Continuous ambulatory cardiac rhythm monitoring using the CardioNet MCOT device
16208809|NCT01325532|Device|Active CES|CES current
16208810|NCT01325532|Device|Sham CES|Sham CES (device off) for 20-minutes each day 5 days/week for 3 weeks.
16208811|NCT01325519|Other|video decision aid|video
16208812|NCT01325506|Other|Questionnaire|Questionnaire, telephone interviews, and clinical follow-up
16208813|NCT01325493|Drug|Ketamine|ketamine 0.5mg/kg intravenous (IV) load followed by an intraoperative continuous infusion at 0.25mg/kg/h and a postoperative infusion at 0.1mg/kg/h
16208814|NCT01325493|Drug|Normal Saline|Normal saline given 0.5mg/kg intravenous (IV) load followed by an intraoperative continuous infusion at 0.25mg/kg/h and a postoperative infusion at 0.1mg/kg/h
16208815|NCT01325480|Device|Cardiac Pacing|
16208816|NCT01325454|Device|pleural pigtail drainage|With the guidance of chest US, 50 ml of pleural fluid was collected using a standard thoracentesis technique immediately or within 24 hr after hospitalization. When pleural effusion was multi-loculated, the fluid was aspirated from the largest loculus. Routine analyses of pleural fluid for total leukocytes, cell differentials of leukocytes, pH value, and levels of protein, glucose and LDH were performed in addition to cytological and microbiologic examination of pleural fluid.The rest of pleural fluid samples were mixed with 3.8 % sodium citrate in a 9:1 ratio of pleural fluid to citrate. The sodium citrate-mixed pleural fluid specimens were immersed in ice immediately and then centrifuged at 2,500 g for 10 minutes. The cell-free supernatants of pleural fluid were frozen at -70℃ immediately after centrifuge for later measurements. The commercially available enzyme-linked immunosorbent assay kits were used to measure the effusion levels of VEGF, IL-8 , tPA and PAI-1.
16208817|NCT01325441|Drug|BBI608|
16208818|NCT01325441|Drug|Paclitaxel|
16208819|NCT01325428|Drug|Afatinib once daily (OD)|Patient to receive afatinib monotherapy until progression of their disease
16208820|NCT01325428|Drug|Vinorelbine Weekly|Patients additionally receive vinorelbine weekly on disease progression on afatinib monotherapy
16208821|NCT01325415|Drug|NKTR-118|25 mg tablet
16208822|NCT01325415|Drug|moxifloxacin|400 mg tablet
16208823|NCT01325415|Drug|Placebo|tablet
16208824|NCT01325402|Other|[18Fluor]AZD4694|Low mass dose below 5ug. High mass dose around 40 and 50 ug.
16208825|NCT01325402|Other|[18Fluor]AZD4694|Low mass dose below 5ug. High mass dose around 20 ug.
16208826|NCT01325402|Other|[18Fluor]AZD4694|Low mass dose below 5ug. High mass dose will be the Maximum Detective Mass established in the previous panels.
16208827|NCT01325389|Dietary Supplement|Myo-Mel|
16208828|NCT01325389|Dietary Supplement|Placebo|
16208829|NCT01325376|Behavioral|Technology assisted health behavior|Web-based interactive program using an hpod sensor that tracks physical activity as well as biometric parameters into the iWell server and is transmitted to the internet site via the users PC. Also serves as a social networking site.
16208830|NCT01325376|Behavioral|Self directed|Receives support and encouragement with minimal contact. Receives printed lifestyle guidelines with diet and physical activity recommendations.
16208831|NCT01325363|Device|Magnetoencephalograph (MEG)|Brain imaging device that records the magnetic fields in the brain.
16208832|NCT01325350|Drug|bimatoprost Formulation A|Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
16208833|NCT01325350|Drug|bimatoprost Formulation B|Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
16208834|NCT01325350|Drug|bimatoprost Formulation C|Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
16208835|NCT01325350|Drug|bimatoprost vehicle solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
16208836|NCT01325350|Drug|minoxidil 2% solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
16208837|NCT01325337|Drug|bimatoprost Formulation A|Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
16208838|NCT01325337|Drug|bimatoprost Formulation B|Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
16208839|NCT01325337|Drug|bimatoprost Formulation C|Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
16208840|NCT01325337|Drug|bimatoprost vehicle solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, once daily for 6 months.
16208841|NCT01325337|Drug|minoxidil 5% solution|Approximately one mL dose applied evenly onto pre-specified area on scalp, twice daily for 6 months.
16208842|NCT01325324|Device|measurement of intraocular pressure|Intraocular pressure will be measured with the following devices (each 2 times)at the first and only study visit
16208843|NCT01325311|Drug|Cholecalciferol|Given PO
16208844|NCT01325311|Drug|Genistein|Given PO
16208845|NCT01325311|Other|Laboratory Biomarker Analysis|Correlative studies
16208846|NCT01325311|Other|Pharmacological Study|Correlative studies
16208847|NCT01325311|Other|Placebo|Given PO
16208848|NCT01325298|Device|UV-X Light|UV-X 365 nm wavelength light source is applied to the cornea with continued application of riboflavin 0.1%
16208934|NCT01324622|Procedure|laminectomy|standard procedure
16208852|NCT01325285|Device|RespirAct|"Participants will breathe through a mask connected to a sequential rebreathing circuit and gas blender. The following seven gas stages will be targeted for about 10 minutes each:
~Baseline, measured in eye A (PETCO2=38mmHg and PETO2=100mmHg)
~10% hypercapnic increase, measured in eye A (PETCO2=42mmHg and PETO2=100mmHg)
~20% hypercapnic increase, measured in eye A (PETCO2=46mmHg and PETO2=100mmHg)
~Baseline, measured in both eyes (PETCO2=38mmHg and PETO2=100mmHg)
~250% hyperoxic increase, measured in eye B (PETCO2=38mmHg and PETO2=250mmHg)
~500% hyperoxic increase, measured in eye B (PETCO2=38mmHg and PETO2=500mmHg)
~Baseline, measured in eye B (PETCO2=38mmHg and PETO2=100mmHg)"
16208853|NCT01325259|Other|neuropsychologic assessment|Mini Mental Status Examination, Mattis dementia rating scale, Geriatric Depression Scale, Edinburgh Inventory, DO 80, 12 irregular words dictation, RL-RI16, DMS 48, Rey complex figure, Stroop test, span right and reverse, praxis, ESR words, ESR drawings, Trail Making Test A and B, code test from WAIS III, Hayling inhibition test, fluences, NPI
16208854|NCT01325259|Radiation|[18F]AV-45 PET|intravenous injection of 4 MBq/kg of [18F]AV-45
16208855|NCT01325259|Radiation|18-FDG PET|intravenous injection of 100 to 120 MBq of FDG
16208856|NCT01325259|Other|MRI|Magnetic Resonance Imaging
16208857|NCT01325233|Drug|PG2|Powder for Injection, 500 mg PG2/500 ml normal saline, tiw, 2 weeks
16208858|NCT01325233|Drug|Placebo|500 ml normal saline, tiw, 2 weeks
16208859|NCT01325220|Drug|arbaclofen|5 mg bid
16208860|NCT01325220|Drug|arbaclofen|10 mg bid
16208861|NCT01325220|Drug|arbaclofen|10 mg tid
16208862|NCT01325220|Drug|Placebo|tid
16208863|NCT01325207|Radiation|Trastuzumab|Trastuzumab will be administered twice per week for 4 weeks, then once per week for 4 weeks, and then every 2 weeks
16208864|NCT01325194|Drug|liposomal cytarabine|50 mg intrathecally three times
16208865|NCT01325181|Drug|Verteporfin|a 6mg/m2 infusion of verteporfin(Visudyne; Novartis)over 10 minutes followed by laser delivery
16208866|NCT01325181|Drug|ranibizumab|Consecutive intravitreal injection of ranibizumab(Lucentis®, Novartis) 0.5mg/0.05ml for the first 3 months
16208867|NCT01325168|Drug|syntocinon nasal spray|nasal oxytocin - 24 IU, 3 inhalations of 4IU to each nostril (45 sec waiting between the inhalations)
16208868|NCT01325168|Drug|placebo nasal spray|nasal placebo - 24 IU, 3 inhalations of 4IU to each nostril (45 sec waiting between the inhalations)
16208869|NCT01325116|Behavioral|Educational Reminder|Personalized letters sent via post to the patient and their family physician at one, five, eight, and eleven months after their angiogram, sent on behalf of the interventional cardiologist. The patient letter provides a review of the role of each of the cardiac medications and urges long-term adherence. The language in the patient letter is simplified to a grade 6 level; this letter was tested for understanding and acceptability amongst a series of Cardiology patients.At the same time, close examination of data from Ontario indicated large stepwise declines in adherence at 30 and 60 days post-STEMI. To address this, patients will be provided an additional postcard type reminder two months post-STEMI.
16208870|NCT01325103|Procedure|Stem Cell Transplantation|All patients will undergo autologous bone marrow stem cell transplantation into the lesion area.
16208871|NCT01325090|Drug|BOTOX|A syringe of 1 ml contain 25 Allergan units.
16208872|NCT01325090|Other|PLACEBO|The pharmacist will fill syringes in tuberculins of 1 ml with injectable solution of sodium chloride of 0,9 %.
16208873|NCT01325077|Other|model of health care service|Conventional model(C): Nurses give fixed-dose analgesic according to surgeons' prescription Study model(S): Nurses give initial-dose analgesic according to surgeons' prescription. In case of inadequate pain relief, another half of initial dose will be given twice at 15-min interval and acute pain service will be consulted if there is still pain.
16208874|NCT01325051|Drug|Raltegravir|400 mg tablets by mouth BID from Day 1 - Day 7 after enrollment visit
16208875|NCT01325038|Procedure|Isometric exercise|Isometric exercise several times/week for three months
16208876|NCT01325025|Other|High-field MRI (3 Teslas)|"anatomical location
~conventional anatomical sequence T1, T2, FLAIR
~diffusion tensor sequence (21 directions)
~high angular resolution diffusion (HARDI) sequence
~field map
~reflexology T1, T2
~spectroscopic imaging sequence"
16208877|NCT01325025|Other|High-field MRI (3 Teslas)|"anatomical location
~conventional anatomical sequence T1, T2, FLAIR
~diffusion tensor sequence (21 directions)
~high angular resolution diffusion (HARDI) sequence
~field map
~reflexology T1, T2
~spectroscopic imaging sequence"
16208878|NCT01325012|Procedure|Subgluteal Sciatic Nerve Block|Patients randomized to this group will receive a sciatic nerve block with the catheter tip insertion at the subgluteal location 1-3 cm caudad to the inferior border of the gluteus maximus muscle. After catheter placement, outcome measures will be assessed.
16208879|NCT01325012|Procedure|Popliteal Sciatic Nerve Block|Patients randomized to this group will receive a sciatic nerve block with the catheter tip insertion at the popliteal location 1-3 cm cephalad to the sciatic bifurcation. After Catheter placement outcome measures will be assessed.
16208880|NCT01324999|Drug|Tadalafil|20mg/day for one month then 40mg/day for additional 4 months
16208881|NCT01324986|Procedure|Laparoscopic anti-reflux surgery|
16208882|NCT01324973|Behavioral|eWellness|A weight management program that includes computerized delivery of evidence-based education regarding diet and physical activity, and peer coaching.
16208883|NCT01324960|Drug|Ceplene®, IL-2, Azacitidine|Azacitidine: 75 mg/m2 subcutaneously daily for 7 days every 4 weeks. Ceplene® / IL2: Patients will receive Ceplene at 0.5 mg subcutaneous twice daily and human recombinant IL-2 at 16 400 U/kg subcutaneous twice daily during 15 days for up to 10 cycles, on days 8 to 21 of AZA cycles.
16208884|NCT01324960|Drug|Azacitidine|Azacitidine 75 mg/m2 subcutaneously daily for 7 days every 4 weeks
16208885|NCT01324947|Drug|pomalidomide|Oral pomalidomide 4 mg on Days 1-21 of 28-day cycle until progressive disease (PD) or unacceptable toxicity
16208886|NCT01324934|Drug|ATG-Fresenius S|"Dosage: Single high-dose of 9 mg/kg pre-operatively, followed by 3 mg/kg/d at day +2 and +4. ATG-Fresenius treatment at Days 0, +2, and +4 is mandatory.
~(In case of persisting DGF, the treatment is left to the discretion of the investigator. Treatment options include the continuation of ATG-Fresenius treatment with 3 mg/kg/d at Day +6 and if deemed necessary also at Day +8 - but without corticosteroids)."
16208887|NCT01324921|Other|No breakfast/beverage only|12 fluid ounces made up of one of some combination of the following: decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener
16208888|NCT01324921|Other|Breakfast|1 serving of unflavored instant oatmeal and 12 fluid ounces made up of one of some combination of the following:decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener
16208889|NCT01324921|Other|10004RF|1 serving (8 fluid ounces) of the experimental beverage and 4 fluid ounces made up of one of some combination of the following:decaffeinated coffee, decaffeinated tea or water, with non-nutritive sweetener
16208890|NCT01324908|Procedure|extracorporeal photopheresis|Undergo ECP
16208891|NCT01324908|Other|laboratory biomarker analysis|Correlative studies
16208892|NCT01324882|Device|Colonoscopy with Olympus Technically Improved Colonoscope|The standard colonoscopy will be performed using the Olympus Technically Improved Colonoscope.
16208893|NCT01324882|Device|Control with standard colonoscope Olympus CF-H180|Standard colonoscopy using the adult scope, Olympus CF-H180.
16208894|NCT01324869|Biological|KH902|Intravitreal injection of 0.5mg/eye/time KH902
16208895|NCT01324856|Procedure|Pancreatico gastro anastomosis|After the pylorus preserving cephalic pancreaticoduodenectomy, pancreatico gasto teremino-lateral anastomosis will be performed. The anastomosis will be done with posterior wall of the stomach. Pancreas will be mobilized at least 5 cm, two tobaco stiches will be applied on posterior wall of the stomach and hole of 2 cm will be done in the middle. Anterior wall of the stomach will be opened, for easier placement of the pancreas in to the stomach cavity. Pancreas will be entered in the stomach trough , tobacco stitches tided and just 2 or 3 stitches will be applied on the stomach mucosa and pancreatic capsule. After that classic hepatico jejuno and antecolic duodeno jejuno anatomosis will ber performed.
16208896|NCT01324856|Procedure|Pancreaticojejuno anastomosis|After the pylorus preserving cephalic pancreaticoduodenectomy, pancreatico jejuno termino lateral duct to mucosa anastomosis will be performed. After that classic hepatico jejuno and antecolic duodeno jejuno anatomosis will ber performed.
16208897|NCT01324843|Drug|EMLA Cream|
16208898|NCT01324843|Drug|Aveeno Daily Moist|
16208899|NCT01324843|Device|Derma Vax|
16208900|NCT01324843|Procedure|Intradermal Electroporation|
16208901|NCT01324843|Procedure|Visual Analogue Scale|
16208902|NCT01324843|Procedure|Present Pain Intensity|
16208903|NCT01324843|Procedure|McGill Pain Questionnaire|
16208904|NCT01324843|Procedure|Skin Assessment|
16208905|NCT01324830|Drug|day 1 to day 5|low to high dose
16208906|NCT01324830|Drug|day 1 to day 14|low to high dose
16208907|NCT01324817|Device|Kai Spot (v 2.1)|The Kai Spot (v 2.1) provides a measurement of respiratory rate at a single point in time for neonates, pediatrics, and adults.
16208908|NCT01324817|Device|Kai Continuous (v 1.0)|The Kai Continuous (v 1.0) provides a continuous monitor, measurement, and display of the respiratory rate, respiratory patterns, depth of breath, history/events and respiratory activity of a subject for neonates, pediatrics, and adults.
16208909|NCT01324791|Procedure|anti-reflux surgery|
16208910|NCT01324778|Device|OsseoSpeed TX|OsseoSpeedTM TX implants of lengths 6-17 mm
16208911|NCT01324778|Device|OsseoSpeed|OsseoSpeedTM implants of lengths 6-17 mm
16208912|NCT01324765|Behavioral|TARGET|12-session group therapy twice weekly 6 weeks
16208913|NCT01324765|Behavioral|SGT|12 sessions supportive group therapy twice weekly 6 weeks
16208914|NCT01324752|Drug|PA21 and Losartan with Food|The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Losartan will be 100 mg/day.
16208915|NCT01324752|Drug|No PA21; Losartan with food|The maximum dose of Losartan will be 100 mg/day.
16208916|NCT01324752|Drug|PA21 with food and Losartan 2 hours later|The maximum dose of PA21 will be 15.0 g/day. The maximum dose of Losartan will be 100 mg/day.
16208917|NCT01324739|Drug|human BNP-32|3pmol/kg/min infusion
16208918|NCT01324700|Drug|High severity group: Escitalopram|Participants within high severity group were stratified to receive escitalopram.
16208919|NCT01324700|Drug|High severity group: Placebo|Participants within high severity group were stratified to receive placebo (inactive ingredient matching the active medication in appearance).
16208920|NCT01324700|Drug|Low severity group: Escitalopram|Participants within low severity group were stratified to receive escitalopram.
16208921|NCT01324700|Drug|Low severity group: Placebo|Participants within low severity group were stratified to receive placebo (inactive ingredient matching the active medication in appearance).
16208922|NCT01324687|Other|Telemedicine care|Availability of telemedicine
16208923|NCT01324674|Other|Bach´s Flower Remedy|The subjects will have 4 drops 4 times per day, for approximately 8 months.
16208924|NCT01324674|Other|Placebo group|The subjects will have a solution non-drug type, 4 drops 4 times per day, for approximately 8 months
16208925|NCT01324661|Behavioral|Ostracism|Participants would received the ball of a computerized ball-tossing game once or twice in the beginning and then never again for the duration of the game.
16208926|NCT01324648|Behavioral|Telephone-supported self-help and GP treatment as usual|"Participants' use of the BB self-help materials will be supported by three to five telephone coaching sessions that occur approximately every 2-3 weeks. Total contact time will be approximately 2 hours (2 hour total contact time will be considered brief in our study). Participants will also continue to receive whatever current treatment their general practitioner is providing."
16208927|NCT01324648|Behavioral|Unsupported self-help and GP treatment as usual|This treatment was chosen as a control for the telephone coaching component of the BB program. Participants will be sent a package containing the BB self-help materials and along with instructions on how to utilize these materials. Participants will use the materials on their own and at their own pace. Participants will also continue to receive whatever current treatment their general practitioner is providing.
16208928|NCT01324648|Other|General practitioner treatment as usual|This group will receive treatment as usual - whereby the clinic staff will inform the participant's GP of their PHQ-9 score. They will also be informed that their GP will be contacted that they are taking part in the research and that their GP will continue to support them with their depression as usual.
16208929|NCT01324635|Drug|Panobinostat|Given PO
16208930|NCT01324635|Radiation|Stereotactic body radiation therapy|Undergo SBRT
16208931|NCT01324635|Procedure|Quality-of-life assessment|Ancillary studies
16208932|NCT01324635|Radiation|Stereotactic radiosurgery|Undergo stereotactic radiosurgery
16208933|NCT01324622|Device|Laminoplasty|Utilizing the ARCH Fixation System (Study device)
16208937|NCT01324583|Drug|Cabazitaxel (XRP6258)|"Pharmaceutical form:solution
~Route of administration: intravenous"
16208938|NCT01324583|Drug|prednisolone|"Pharmaceutical form:tablet
~Route of administration: oral"
16208939|NCT01324570|Drug|Buprenorphine transdermal system|Buprenorphine transdermal system 2.5 mcg/h, 5 mcg/h, 10 mcg/h or 20 mcg/h applied transdermally for 7-day wear.
16208940|NCT01324557|Procedure|CSII and MDI|The aims of this study are to assess the potential efficacy and safety of insulin pump(MiniMed Paradigm® REAL-Time Revel™ Insulin Pump) to improve glycemic control in conjunction with continuous glucose monitoring (CGMS) for diabetic CAPD Patients.
16208941|NCT01324544|Drug|Buprenorphine IV|Buprenorphine IV administered via patient-controlled analgesia (PCA) pump for at least 24 hours and up to 72 hours.
16208942|NCT01324531|Procedure|Bankart repair and remplissage|Bankart repair may be completed before or after remplissage. While maintaining camera in anterior-superior portal drill guide and anchor cannula is placed through the posterior portal into remplissage site. Anchor cannula with obturator is passed through infraspinatus tendon and posterior capsule via pre-existing portal, and first anchor is placed in inferior aspect of Hill-Sachs lesion.Once anchor is inserted, penetrating grasper is passed through tendon and posterior capsule, 1 cm inferior to the initial portal entry site, to grasp and pull 1 suture limb.Second anchor is placed in superior aspect of Hill-Sachs lesion and grasper penetrator is used in same fashion to pass 1 suture limb 1 cm superior to initial portal entry site. The inferior suture is tied first with knots remaining extraarticular in the subdeltoid space. The superior suture is tied to complete remplissage.
16208943|NCT01324531|Procedure|Bankart repair|Bankart repair based on surgeon's preference
16208944|NCT01324518|Drug|ORM-12741|60mg twice a day
16208945|NCT01324518|Drug|ORM-12741|200mg twice a day
16208946|NCT01324518|Drug|Placebo for ORM-12741|Placebo twice a day
16208947|NCT01324505|Drug|semaglutide|Semaglutide will be administered once weekly by s.c. (under the skin) injections in the abdomen. A total of 13 doses of semaglutide will be administered according to a predefined dosing scheme
16208948|NCT01324505|Drug|placebo|Placebo semaglutide will be administered once for securing eligibility of subjects (willingness and ability to self inject) at the screening visit.
16208949|NCT01324505|Drug|Microgyn®|Microgyn® will be given as once daily oral dosing in two periods, each of 8 days' duration. One tablet contains levonorgestrel 0.15 mg and ethinylestradiol 0.03 mg.
16208950|NCT01324492|Drug|RAD001|
16208951|NCT01324479|Drug|INC280|
16208952|NCT01324466|Drug|NB-001|Topical, 5 times daily until investigator assessment of healing or a maximum of 4 days
16208953|NCT01324466|Drug|Vehicle|Topical, 5 times daily until investigator assessment of healing or a maximum of 4 days
16208954|NCT01324453|Procedure|Post Conditioning + Primary PCI|Four, 30-second PTCA balloon occlusions followed by 30-seconds of reperfusion over a total of 4 minutes, in addition to Percutaneous Coronary Intervention as clinically indicated.
16208955|NCT01324453|Procedure|Standard Primary PCI|Routine Percutaneous Coronary Intervention as clinically indicated.
16208956|NCT01324440|Biological|V710 (30 µg) with MAA|Single 0.5-mL injection (30-µg) of V710 with MAA, intramuscularly
16208957|NCT01324440|Biological|V710 (30 µg) without MAA|Single 0.5-mL injection (30-µg) dose of V710 without MAA, intramuscularly
16208958|NCT01324427|Behavioral|virtual medical visit|"At the pre-set time, the Mobile Telehealth Cart will be set up in the exam room or the clinic office, and a connection with the doctor will be made through their computer. The telemedicine visit will be conducted at the same time as the regular clinic visit. During the visit, the nurse will evaluate the physical symptoms, vital signs, past medical history, present medical history, and any side effects from the autologous or allogeneic transplant. The nurse will place a digital stethoscope on the chest to listen to the heart and lungs. The virtual medical visit will take about 25 minutes. At the end of the Virtual Medical Visit, the patient will evaluate the event using a survey to assess the acceptance of the virtual visit. The surveys will be written and should take around 15 minutes to complete. The answers provided will be shared with the MD and nurses after the patient has completed all their virtual medical visits."
16208959|NCT01324401|Drug|Peanut flour OIT|Patients will receive daily escalating dosages (Peanut flour OIT) as determined in the modified rush phase as stated in the protocol. The dosage will be escalated until a daily dose of 4000 mg is reached. A Double-blind, placebo-controlled food challenge will then consist of two challenges performed on the same day. One challenge will consist of 7 doses of peanut given every 10-20 minutes in increasing amounts up to a total of 10 grams of whole peanut (5 grams of peanut protein) masked by inclusion in vehicle food. The other challenge will consist of placebo material given similarly.
16208960|NCT01324388|Biological|LY2189265|Administered subcutaneously
16208961|NCT01324388|Drug|Metoprolol|Administered orally
16208962|NCT01324388|Drug|Lisinopril|Administered orally
16208963|NCT01324388|Drug|Placebo|Administered subcutaneously
16208964|NCT01324375|Device|heat pain test (Modular Sensory Analyzer, Somedic AB, Horby, Sweden).|pain during heat test preoperatively
16208965|NCT01324362|Drug|Placebo|Twice daily dosing
16208966|NCT01324362|Drug|Placebo|Twice daily dosing
16208967|NCT01324362|Drug|FP 100mcg|Twice daily dosing
16208968|NCT01324362|Drug|FP 250mcg|Twice daily dosing
16208969|NCT01324362|Drug|FP 500mcg|Twice daily dosing
16208970|NCT01324362|Drug|FSC 100/50mcg|Twice daily dosing
16208971|NCT01324362|Drug|FSC 250/50mcg|Twice daily dosing
16208972|NCT01324362|Drug|FSC500/50mcg|Twice daily dosing
16208973|NCT01324349|Device|Veriset Hemostatic Patch|Topical hemostat
16208974|NCT01324349|Device|Fibrin Sealant (TachoSil®)|Topical hemostat
16208975|NCT01324336|Drug|6-Mercaptopurine|75 mg/m2/dose/day
16208976|NCT01324323|Drug|Romidepsin|14 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8.
16208977|NCT01324323|Drug|Rifampin|600 mg oral once daily on Days 4-8
16208978|NCT01324310|Drug|Romidepsin|Romidepsin 8 mg/m^2 intravenous infused over 4 hours on Day 1 and Day 8.
16208979|NCT01324310|Drug|Ketoconazole|Ketoconazole 400 mg oral once daily on Days 4-8
16208980|NCT01324297|Other|skin test|four patches of 2 x 3cm thin blotting paper will be soaked with an equivalent amount (0.1 mL) of aqueous methyl nicotinate in four different concentrations: 0.1, 0.01, 0.001, 0.0001 M. The four patches will then be applied at the same time to the inner forearm for 60 seconds.
16208981|NCT01324284|Drug|Lubiprostone|Lubiprostone is a chloride channel activator approved by the Food and Drug Administration for the treatment of chronic constipation. A randomized, double-blind, parallel-group, placebo-controlled study evaluating the effect of lubiprostone on gastric function showed slowed gastric emptying and increased small bowel and colonic transit time. Peak plasma concentration was shown to be around 1.14 hours, with a majority of the drug excreted in the urine within 48 hours.
16208982|NCT01324271|Device|Acclarent Tympanostomy Tube Delivery system (TTDS)|placement of tympanostomy tube under local anesthesia
16208983|NCT01324258|Drug|GSK1120212|Part1 and Part2
16208984|NCT01324258|Drug|Gemcitabine|Part2
16208985|NCT01324245|Drug|Fenoldopam|Intravenous infusion at 0.5 mics/Kg/min for three hours
16208986|NCT01324232|Drug|AVP-923|AVP-923 capsules administered twice-a-day, over a 12 week period
16208987|NCT01324232|Drug|Placebo|Matching placebo
16208988|NCT01324219|Behavioral|Staff|Your participation will involve participating in video recordings of nursing care for a participating resident for 2-hour periods on 8 to 10 days. Communication training will be provided to staff in participating nursing homes during paid work hours regardless of their participation in the video recordings. The nursing home you work in may be randomly selected to receive the communication training at the start of the study or after a 3-month delay.
16208989|NCT01324219|Behavioral|Resident|Your participation will involve participating in video recordings of nursing care for 2-hour periods on 8 to 10. Communication training will be provided to staff in participating facilities during paid work hours regardless of their participation in the video recordings. Your nursing home may be randomly selected to receive the communication training at the start of the study or after a 3-month delay.
16208990|NCT01324193|Dietary Supplement|Pomegranate extracts|a 1000mg capsule of a purified pomegranate polyphenol supplement (POMx™, POM Wonderful, Inc. Los Angeles, CA)7 days a week for 12 months.
16208991|NCT01324180|Drug|Metformin|Will be dosed orally BID as per dose level of subject as defined in dose escalation schema. Both liquid and tablet forms are allowed and can be chosen based on convenience. Metformin will be continued throughout the cycle until Day 28 or until the patient is removed from study (e.g. to pursue new lines of therapy such as transplant), whichever occurs sooner.
16208992|NCT01324180|Drug|Vincristine|1.5 mg/m^2/dose IV push (maximum single dose 2 mg) on days 2, 9, 16 and 23
16208993|NCT01324180|Drug|Dexamethasone|"10 mg/m^2/day divided BID
~Take dexamethasone by mouth days 2-15"
16208994|NCT01324180|Drug|PEG-asparaginase|"2500 IU's/m^2/day
~Intramuscular injection (IM) or intravenous infusion per institutional standard on days 3, 9, 16 and 23
~If the patient develops an allergic reaction to PEG while being treated on this protocol, eliminate all future doses of PEG and substitute Erwinia if not intolerant of Erwinia and has no history of pancreatitis.
~Patients will receive Erwinase® 25,000 IU/m^2 x 6 doses intramuscularly (IM) on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase on the original protocol."
16208995|NCT01324180|Drug|Doxorubicin|60 mg/m^2/day IV over 15 minutes on day 2
16208996|NCT01324180|Drug|Intrathecal chemotherapy|"IT cytarabine given intrathecally to all patients on day 1 of each cycle. Dose defined by age. May be given with staging lumbar puncture before enrollment, but must be within 72 hours of starting therapy. If not done at study entry or before, may be done on Day 2 prior to doxorubicin administration.
~30 mg for patients age 1-1.99
~50 mg for patients age 2-2.99
~70 mg for patients greater than 3 years of age IT methotrexate given Intrathecally to all patients who are CNS negative at study entry on day 16 at the dose defined by age."
16208997|NCT01324141|Drug|Tempol|Tempol gel will be applied to the bilateral groins and the gluteal cleft, avoiding a 3 cm radius from the anal verge, immediately prior to each fraction of RT.
16208998|NCT01324141|Drug|5-Fluorouracil|5-FU will be delivered as 1000mg/m2/day as 96 hour continuous infusion beginning on day 1 and 29.
16208999|NCT01324141|Drug|Mitomycin-C|MMC will be delivered at a dose of 10mg/m2 on days 1 and 29
16209000|NCT01324141|Procedure|Radiation Therapy|RT will be delivered to a total dose of 50-54 Gy based on tumor characteristics.
16209001|NCT01324128|Drug|PA21 (2.5 g tablet containing 500 mg iron)|Dose range of 5.0 g/day (2 tablets/day) to 15.0 g/day (6 tablets/day).
16209002|NCT01324128|Drug|Sevelamer carbonate|Dose range of 2.4 g/day (3 tablets/day) to 14.4 g/day (18 tablets/day)
16209003|NCT01324128|Drug|PA21-1 (1.25 g tablet containing 250 mg iron)|Low dose comparator (1.25 g/day)
16209004|NCT01324115|Drug|NG-nitro-L-arginine|
16209005|NCT01324115|Other|laboratory biomarker analysis|
16209006|NCT01324115|Other|pharmacological study|
16209007|NCT01324115|Procedure|computed tomography|
16209008|NCT01324115|Procedure|dynamic contrast-enhanced magnetic resonance imaging|
16209009|NCT01324102|Behavioral|Yoga therapy|For the second aim of the study, individuals will complete an 8 week yoga intervention in a non-randomized trial to establish safe procedures for yoga for an older post colorectal cancer veteran population.
16209010|NCT01324089|Dietary Supplement|Resveratrol|Resveratrol 2.5 grams
16209011|NCT01324089|Dietary Supplement|Resveratrol 2.5 grams x 1 dose and Piperine 5 mg x 1 dose|Resveratrol 2.5 grams x 1 dose and Piperine 5 mg x 1 dose
16209012|NCT01324089|Dietary Supplement|Resveratrol 2.5 grams x 1 dose and Piperine 25 mg x 1 dose|Resveratrol 2.5 grams x 1 dose and Piperine 25 mg x 1 dose
16209013|NCT01324076|Drug|doxorubicin-eluting beads|
16209014|NCT01324076|Drug|sorafenib tosylate|
16209015|NCT01324076|Other|laboratory biomarker analysis|
16209016|NCT01324076|Other|pharmacogenomic studies|
16209017|NCT01324076|Other|pharmacological study|
16209018|NCT01324076|Procedure|quality-of-life assessment|
16209019|NCT01324063|Biological|sargramostim|
16209020|NCT01324063|Drug|amsacrine|
16209021|NCT01324063|Drug|cytarabine|
16209022|NCT01324063|Drug|daunorubicin hydrochloride|
16209023|NCT01324063|Procedure|quality-of-life assessment|
16209024|NCT01324050|Behavioral|Internet-delivered psychodynamic therapy for depression|This intervention contains 9 text-based self-help modules. These modules contain material inspired by psychoanalytic theory about identifying reoccurring patterns in life among other things. In addition to the self-help modules, 10-15 minutes of therapist contact is given every week. In total, the intervention will last for 10 weeks.
16209067|NCT01323647|Biological|Infanrix+Hib|Single dose, intramuscular injection. Part of the local standard of care. No outcome measures associated.
16209025|NCT01324050|Behavioral|Internet-delivered therapist support|This intervention contains 1 text-based self-help module, which is mainly based on information on depression. In addition to this text, the participants in this group gets 10-15 minutes of therapist contact every week. In the conversation with the therapist, the participant informs the therapist about the activities during the week. This intervention is considered to be a form of support. In total, the intervention will last for 10 weeks.
16209026|NCT01324037|Other|diagnostic algorithm|diagnostic algorithm consisting of a clinical decision rule, D-dimer and (serial) ultrasonography
16209027|NCT01324024|Drug|Lisdexamfetamine|In a counterbalanced fashion, participants would receive titrated doses of LDX 20 to 60 mg/d for 4 weeks followed by a 2-week washout and then crossed over to the placebo tablets for another 4 weeks. All women will start with LDX 20 mg/d and then be titrated to 40 mg/d after 1 week and 60 mg/d after 2 weeks (as tolerated).
16209028|NCT01324024|Drug|Placebo|In a counterbalanced fashion, participants would receive placebo tablets for 4 weeks followed by a 2 week washout, then will receive titrated doses of LDX 20 to 60 mg/d for 4 weeks.
16209029|NCT01324011|Behavioral|Adult diabetes family-based weight loss intervention|Participants assigned to the experimental group will begin the 2o-week weight loss intervention, while delayed intervention controls will wait until the end of this period to begin their program. The weight loss intervention includes 20 weekly group-based sessions facilitated by a registered dietitian. Each group session will last about 120 minutes and include: weight check, group sharing and problem-solving, discussion of a weight control topics (nutrition, physical activity, or behavior change), physical activity and/or taste-testing. Ten sessions will include a brief component, focused on improving family relationships for better diabetes self-care. The study weight loss goal is ≥10 pounds (minimum rate-0.5 lb/week; maximum-2 lbs/week). While the control group waits, they will receive 1 newsletter with study updates and general health or diabetes information. The delayed intervention includes 6 sessions (4 weekly + 2 bi-weekly) following the same format as the experimental group.
16209030|NCT01323998|Drug|5ARI|Dutasteride or Finasteride
16209031|NCT01323998|Drug|AB|Doxazosin, Prazosin, Tamsulosin, Terazosin or Alfuzosin
16209032|NCT01323985|Drug|GSK2315698|5mg-400mg IV (in the vein) single dose over 1-4 hours
16209033|NCT01323985|Drug|GSK2315698|IV (in the vein) single dose over 24 hours, in two sessions
16209034|NCT01323972|Biological|GSK Biologicals' candidate Plasmodium falciparum malaria vaccine (257049)|4 different lots of the candidate malaria vaccine (257049) representative of either commercial (manufacturing) process or pilot plant process
16209035|NCT01323959|Biological|BoostrixTM Polio|Single dose, intramuscular administration.
16209036|NCT01323946|Biological|GSK Biologicals' investigational vaccine GSK1562902A|Three intramuscular injections
16209037|NCT01323933|Drug|AB0024|Comparison of different dosages of drug
16209038|NCT01323920|Drug|Bortezomib|Bortezomib 1.3 mg/m^2 IV
16209039|NCT01323920|Drug|Tacrolimus|Tacrolimus 0.05 mg/kg PO bid
16209040|NCT01323920|Drug|Methotrexate|Methotrexate 15 mg/m^2 IV
16209041|NCT01323907|Drug|Omegaven IV lipid emulsion|For infants meeting inclusion criteria and whose guardians consent to participation, Omegaven will be initiated at the dose of 0.5gram/kg/day and is infused over 24 hours for 1-2 days and then advanced to 1 gram/kg/day. Omegaven will be infused intravenously through a central or peripheral catheter alone or in conjunction with parenteral nutrition.
16209042|NCT01323881|Device|Intermittent theta burst stimulation|Intermittent theta burst stimulation with 1200 pulses or sham stimulation over the ipsilesional M1 hand region for 10 daily sessions in 2 weeks.
16209043|NCT01323855|Drug|Preladenant|After an overnight fast, a single 5 mg dose, (1 x 5 mg tablet) was administered orally
16209044|NCT01323842|Procedure|EDTU|bedside ultrasound imaging by the treating emergency physician
16209045|NCT01323829|Other|EMG Guidance of Injection|The use of the EMG guidance is the experimental part of the study. We will perform EMG Needle testing in order to pin-point the best location for the patients Botox injections.
16209046|NCT01323816|Other|Medically directed care|There is no research directed care. Patients are treated as medically indicated.
16209047|NCT01323790|Drug|NKTR-118|12.5 mg oral tablet once daily
16209048|NCT01323790|Drug|NKTR-118|25 mg oral tablet once daily
16209049|NCT01323790|Drug|Placebo|Placebo to NKTR-118
16209050|NCT01323777|Device|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL|Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
16209051|NCT01323764|Device|ShuntCheck test|Non-invasive, thermal dilution test for CSF shunt flow compared to radionuclide shunt patency testing
16209052|NCT01323751|Drug|ACY-1215|Liquid oral dose on Days 1-5 and 8-12 of 21-day treatment cycle
16209053|NCT01323738|Behavioral|Psychoeducation|Psychoeducation group on stress and how it relates to alcohol use, 4 sessions a 45 minutes
16209054|NCT01323725|Behavioral|Team-based financial incentives|Team-based financial incentives for smoking cessation at 6 month post-quit date.
16209055|NCT01323712|Dietary Supplement|Vitamin D Cholecalciferol|Cholecalciferol 100,000 Units 6 doses; 0,4,8,12,24,42 weeks
16209056|NCT01323699|Behavioral|Cognitive Behavioral Therapy|A modified version of existing Cognitive Behavioral Treatment and Self-management manuals.
16209057|NCT01323686|Other|Imaging guided optimal LV lead placement|"LV lead placement guided by cardiac imaging using echocardiography, single-photon emission computed tomography, and CT to target a cardiac vein at the site of latest mechanical activation without scar tissue.
~Visualization of cardiac venous anatomy is performed using cardiac CT if not contraindicated by depressed renal function (estimated glomerular filtration rate <30 ml/min) or allergy to contrast media. In that case, a coronary venogram is used."
16209058|NCT01323673|Drug|clobetasol propionate 0.05%|2 times a day, 14 total days study treatment
16209059|NCT01323673|Drug|Vehicle / Placebo|2 times a day, 14 total days of study treatment
16209060|NCT01323660|Drug|GSK573719/GW642444 125/25|125mcg/ 25mcg QID (Once daily , inhaled)
16209061|NCT01323660|Drug|GSK573719/GW642444 62.5/25|62.5mcg/25mcg QID
16209062|NCT01323660|Drug|GSK573719 125|125mcg QID
16209063|NCT01323660|Drug|GSK573719 62.5|62.5mcg QID
16209064|NCT01323660|Drug|GW642444 25|25mcg QID
16209065|NCT01323660|Device|placebo|Comparator QID
16209066|NCT01323647|Biological|PoliorixTM|Single dose, intramuscular administration
16209069|NCT01323634|Drug|Fluticasone Propionate 250mcg/ salmeterol 50mcg|inhalation powder
16209070|NCT01323621|Drug|Fluticasone Furoate 100mcg/ GW642444 (vilanterol) 25mcg|inhalation powder
16209071|NCT01323621|Drug|Fluticasone Propionate 250mcg / salmeterol 50mcg|inhalation powder
16209072|NCT01323621|Drug|Double-dummy placebo|inhalation powder
16209073|NCT01323621|Drug|Salbutamol as needed|inhalation powder
16209074|NCT01323608|Drug|Vitamin D3|Vitamin D3 will be given at the equivalent of the following doses: 400, 1000, and 2000 IU/day.
16209075|NCT01323608|Drug|Placebo|Placebo
16209076|NCT01323595|Drug|Celecoxib|Celecoxib 200mg PO BID x 6 days
16209077|NCT01323595|Drug|Sugar Pill|Sugar pill PO BID x 6 days
16209078|NCT01323582|Drug|Erythromycin|200mg/5ml elixir administered orally three times a day half an hour prior to meals.
16209079|NCT01323582|Drug|Azithromycin|The dose of Azithromycin given was determined based on the following study on 10 healthy subjects. In random order, each of ten healthy subjects underwent OBT studies following administration of AZI, at doses of 50mg, 100mg, and 133mg. The T½ and Tlag was then compared for the three doses by a randomized block analysis using Analysis of Variance followed by Tukey's multiple comparison. Results: The T½ for each of the respective doses of AZI (50mg, 100mg, and 133mg) was 129 ± 27, 128 ± 31, and 128 ± 16 minutes (p = 0.98). This data suggested that AZI at doses of 50mg, 100mg and 133 mg have fairly similar activity in its effects on gastric emptying in healthy subjects. Based on this analysis , we decided to use a dose of 50 mg/5 ml for administered TID prior to meals.
16209080|NCT01323569|Drug|Sativex|Sativex dose level 1: 10.8 mg THC/10 mg CBD (4 sprays) + 12 placebo sprays + 4 placebo capsules.
16209081|NCT01323569|Drug|Sativex|Sativex dose level 2: 21.6 mg THC/20 mg CBD (8 sprays) + 8 placebo sprays + 4 placebo capsules
16209082|NCT01323569|Drug|Sativex|Sativex dose level 3: 43.2 mg THC/40 mg CBD (16 sprays) + 4 placebo capsules
16209083|NCT01323569|Drug|Placebo|16 placebo sprays and 4 placebo capsules
16209084|NCT01323569|Drug|Marinol|Marinol dose level 1: 20 mg THC (2 marinol capsules) + 2 placebo capsules + 16 placebo sprays
16209085|NCT01323569|Drug|Marinol|Marinol dose level 2: 40 mg THC (4 marinol capsules) + 16 placebo sprays
16209086|NCT01323556|Behavioral|Cognitive Behavioural Therapy (CBT)|12 sessions of CBT including psychoeducation, behavioral analyses, interoceptive exposure and in-vivo exposure with interoceptive exposure during in vivo exposure
16209087|NCT01323556|Behavioral|Cognitive Behavioural Therapy (CBT)|12 sessions of CBT including psychoeducation, behavioral analyses, interoceptive exposure and in-vivo exposure without additional fear augmenting strategies
16209088|NCT01323543|Device|Elaspine™|Implantation of device
16209089|NCT01323530|Drug|Eribulin mesylate|Intravenous (IV) bolus or infusion.
16209090|NCT01323530|Drug|Capecitabine|Oral film-coated tablets.
16209091|NCT01323517|Drug|Ipilimumab, Melphalan and Dactinomycin|Isolated limb infusion ((ILI) with Melphalan and Dactinomycin- MSKCC operating room. Ipilimumab- IV administration in outpatient chemotherapy clinic. Induction therapy with Ipilimumab will start 1-3 weeks after ILI in the standard dose of 10mg/kg every 3 weeks for a total of 4 doses. Patients will then receive chronic therapy every 3 months. Patients will be followed every 3 months for 2 years.
16209092|NCT01323504|Other|Music|Patient are listen music during their local care
16209093|NCT01323504|Other|no music|There are no music during the local care
16209094|NCT01323491|Drug|Nicotine replacement therapy|Nicorette® TX tape 10mg, 15mg, 25mg Nicorette® microtab 2mg Nicorette® inhaler 10mg Nicorette® chewing gum 2 mg, 4mg freshfruit, freshmint, mint, whitemint
16209095|NCT01323478|Drug|Vortioxetine (Lu AA21004)|15 or 20 mg/day; tablets; orally
16209096|NCT01323465|Drug|Sativex and rifampicin|Single dose of 4 sprays Sativex on Day 1, Rifampicin 2 x 300 mg capsules on Days 2-10, Sativex dose of 4 sprays and rifampicin 2 x 300 mg capsules on Day 11.
16209097|NCT01323465|Drug|Sativex and rifampicin|Rifampicin 2 x 300 mg capsules on Days 1-9, Sativex x 4 sprays and rifampicin 2 x 300 mg capsules on Day 10, Single dose of Sativex 4 sprays on Day 18.
16209098|NCT01323465|Drug|Sativex and ketoconazole|Single dose of 4 sprays Sativex on Day 1, ketoconazole 2 x 200 mg tablets on Days 2-5, Sativex x 4 sprays and ketoconazole 2 x 200mg on Day 6.
16209099|NCT01323465|Drug|Sativex and ketoconazole|Ketoconazole 2 x 200 mg tablets on Days 1-4, Sativex x 4 sprays and ketoconazole 2 x 200 mg tablets on Day 5, Single dose of 4 sprays Sativex on Day 9.
16209100|NCT01323465|Drug|Sativex and omeprazole|Single dose of 4 sprays of Sativex on Day 1 Omeprazole 2 x 20 mg on Days 2-6. Sativex x 4 sprays and omeprazole 2 x 20 mg on Day 9.
16209101|NCT01323465|Drug|Sativex and omeprazole|Omeprazole 2 x 20 mg on Days 1-5, Sativex x 4 sprays and omeprazole 2 x 20 mg on Day 6, Single dose of 4 sprays Sativex on Day 9.
16209102|NCT01323452|Drug|Entecavir|once daily
16209103|NCT01323439|Device|Axium™ MicroFX™ PGLA COILS|Axium™ MicroFX™ PGLA COILS to treat aneurysms
16209104|NCT01323426|Procedure|Periurethral injection|Periurethral injection of autologous muscle fibers
16209105|NCT01323400|Drug|Pazopanib|Pazopanib is administered orally at 800 mg/day (one dose every morning). A dose modification is possible in case of documented toxicity, according to specific algorithms.
16209106|NCT01323400|Other|Best supportive care|"Best supportive care according to the investigator's judgment (chemotherapy, immunotherapy, hormone therapy are not allowed).
~Non-targeted radiation therapy is tolerated, as antalgic strategy. Surgery is tolerated in case of emergency."
16209107|NCT01323387|Device|Interbody Fusion|allograft spacer + anterior plate
16209108|NCT01323374|Drug|Droxidopa|Oral, 200mg, 400mg or 600mg TID, duration includes up to a 1 week blinded titration period followed by an 8 week treatment period.
16209109|NCT01323374|Drug|Carbidopa|Oral, 25mg, or 50mg TID, duration includes up to a 1 week blinded titration period followed by an 8 week treatment period.
16209110|NCT01323374|Drug|Droxidopa/carbidopa|Oral, 200mg/25mg, 400mg/25mg, 600mg/25mg, 200mg/50mg, 400mg/50mg, or 600mg/50mg TID. Duration includes up to a 1 week titration period followed by an 8 week treatment period.
16209111|NCT01323374|Drug|Placebo|Oral, placebo TID
16209112|NCT01323361|Procedure|Laparoscopic ventral hernia repair|Patients operated with laparoscopic repair of ventral or incisional hernia
16209141|NCT01323166|Procedure|Excision of the levator muscle|Cylindrical perineal excision including the levator muscle
16209142|NCT01323153|Drug|dalcetrapib|Oral doses of 600 mg once daily for 20 weeks
16209113|NCT01323348|Behavioral|Diabetes Education|"The intervention will consist of the following at enrollment and at each follow-up visit (but no more frequently than once every 12 weeks):
~Measurement of HbA1c in office with immediate feedback
~Measurement of blood pressure with immediate feedback
~Assessment of retinopathy risk with immediate feedback
~Personalized risk assessment reports based on current HbA1c
~Brief assessment of patient understanding of key issues with immediate feedback
~Supplemental diabetes management educational materials (provided at baseline only)
~Feedback to primary care provider
~Email reminder to study participants with email access of individualized risk assessment findings"
16209114|NCT01323335|Drug|IV Uric Acid|
16209115|NCT01323335|Drug|IV Rasburicase|
16209116|NCT01323309|Behavioral|Individual Meaning-Centered Psychotherapy (IMCP)|IMCP is based on the principles of Viktor Frankl's Logotherapy, and is designed to help patients with advanced cancer sustain or enhance a sense of meaning, peace and purpose in their lives even as they approach the end of life. IMCP is structured as a 7-session (1-hour weekly sessions) individual intervention that utilizes a mixture of didactics, discussion and experiential exercises that focus around particular themes related to meaning and advanced cancer. In addition we will be asking patients in the IMCP arm to complete an optional weekly session rating survey
16209117|NCT01323309|Behavioral|standard Individual Supportive Psychotherapy (ISP)|The ISP intervention utilized as the comparison treatment condition in this study, is adapted from the Supportive Group Psychotherapy manualized intervention developed by David Payne (1997) and adapted by Drs. Kissane, Breitbart and colleagues into the ISP manualized intervention. This intervention is a 7-session individual supportive psychotherapy utilizing an approach to supportive psychotherapy based on models described by Rogers. The essential components of supportive psychotherapy are integrated into this manualized intervention, including: reassurance, explanation, guidance, suggestion, encouragement, affecting changes in patient's environment, and permission for catharsis.
16209118|NCT01323309|Behavioral|enhanced usual care (EUC)|"We are therefore including what we refer to as an enhanced usual care arm to this randomized controlled trial to address the ethical issues raised by utilizing a usual care condition in a vulnerable advanced cancer population. Participants will receive feedback about their level of distress (based on the DT administered at screening) and given appropriate targeted referrals based on levels of distress and problem areas endorsed. Participants will be given a letter with a list of appropriate referrals."
16209119|NCT01323296|Other|Ferumoxytol|One dose of intravenous ferumoxytol (4 mgFe/kg body weight at a rate of up to 1 mL/sec)
16209120|NCT01323283|Dietary Supplement|Omega-3|This group will receive capsules containing omega-3, omega-6 and vitamin E. The dosage is six capsules per day containing a total of 558 mg of eico-pentaenoic acid (EPA), 174 mg of docosahexaeonic acid (DHA), 60 mg of gamma-linolenic acid (GLA) and 9,6 mg vitamin E in natural form (alfa-tocopherol), gelatine, glycerol. Participants will be instructed to eat three capsules each morning and evening.
16209121|NCT01323283|Dietary Supplement|Placebo|This group will receive capsules containing rape seed oil. Participants will be instructed to eat three capsules each morning and evening.
16209122|NCT01323270|Biological|rLP2086|0.5 mL dose, given at 0, 2 and 6 months.
16209123|NCT01323270|Biological|Repevax|0.5 mL dose, given at 0 months.
16209124|NCT01323270|Biological|Saline|0.5 mL dose, given at 0, 2 and 6 months.
16209125|NCT01323270|Biological|Repevax|0.5 mL dose, given at 0 months.
16209126|NCT01323257|Drug|erythromycin|500 mg tablets three times a day for 6 days + 1 morning dose for 7th day (Trt B)
16209127|NCT01323257|Drug|Ritonavir|100 mg tablet once daily for 7 days (Trt E, F)
16209128|NCT01323257|Drug|TMC435|150 mg capsule once daily for 7 days (Trt A, C, D)
16209129|NCT01323257|Drug|Darunavir|2 x 400 mg tablet once daily for 7 days (Trt E, F)
16209130|NCT01323257|Drug|TMC435|50 mg capsule once daily for 7 days (Trt F)
16209131|NCT01323257|Drug|erythromycin|500 mg tablets three times a day for 7 days (Trt C)
16209132|NCT01323244|Drug|TMC435|Type=exact number, unit=mg, number=150, form=capsule, route=oral use, once daily for 12 weeks in addition to peginterferon alfa-2a peginterferon and ribavirin for 24 or 48 weeks
16209133|NCT01323231|Behavioral|XY-Zone|"The XY-Zone works to empower students to decrease risk factors and increase protective factors through three linear treatment steps. The first step is driven by guiding principles known as the five R's: respect, responsibility, relationship, role modeling, and reaching out. Through these principles, the participant explores healthy psychosocial behaviors and thoughts in a structured 10 session group setting. The leadership step builds upon the guiding principles and employs activities exploring true leadership through 10 sessions. During the leadership step, participants organize and carry out a service learning projects in their community. The third and final step is ambassador. Those in the ambassador step become a mentor to those in step one and are expected to explore the principles of leadership and the five R's, and determine their personal relevance to their lives as young men (Allen, 2009, p. i)."
16209134|NCT01323218|Drug|25 OH vitamin D|After written informed consent, patients will be randomized to receive a single dose of oral vitamin D (400 000 UI) or placebo. Subjects will undergo medical screening before randomisation into placebo or active group. Follow-up measurements will be performed at the beginning (day 0) and after 32 days of vitamin D supplementation: clinical examination, biological check up and sleep parameter evaluation. Patients will be instructed to stop using continuous positive airway pressure device for two nights before nocturnal sleep studies
16209135|NCT01323205|Drug|JNJ-40411813|JNJ-40411813 starting dose from 50 to 150 mg according to tolerability dose range increased stepwise from 50 mg to 150 mg capsule by mouth orally. Capsule (s) taken twice daily with a meal for 12 weeks.
16209136|NCT01323205|Drug|JNJ-40411813|JNJ-40411813 starting dose from 50 to 150 mg as an add-on therapy. Dose is increased step-wise from 50 mg to 150 mg. Capsule(s) taken by mouth twice daily with a meal for 10 weeks.
16209137|NCT01323205|Drug|Placebo|Placebo capsule (s) orally twice daily with a meal for 4 weeks.
16209138|NCT01323205|Drug|Antipsychotic medication|Regular antipsychotic medications (Risperidone, Olanzapine, Clozapine, Amisulpride, Quetiapine, Paliperidone, Aripiprazole, Haloperidol, Levomepromazine, Zuclopenthixol Hydrochloride, Clotiapine, Pipamperone Hydrochloride, Benperidol, Flupentixol, Fluphenazine Decanoate, Melperone Hydrochloride, or Chlorpromazine Hydrochloride) will be continued in Part B.
16209139|NCT01323192|Drug|JNS001|Participants will receive JNS001 (18 mg, 36 mg, 54 mg or 72 mg per day) orally once daily for 8 weeks.
16209140|NCT01323192|Drug|Placebo|Participants will receive matching placebo orally once daily for 8 weeks.
16209143|NCT01323153|Drug|placebo|Oral doses of matching placebo to dalcetrapib once daily for 20 weeks
16209144|NCT01323140|Drug|testosterone matrix transdermal system|
16209145|NCT01323127|Procedure|Sagital xrays|5 xrays will be taken: (1) Upright standing position; (2) Upright, straight chair position; (3) Slouching, straight chair position; (4) Upright, ergonomic chair position; (5) Slouching, ergonomic chair position.
16209146|NCT01323114|Procedure|Laparoscopic duodenal exclusion|Laparoscopically-performed Roux-en Y intestinal bypass of the duodenum and proximal jejunum; stomach remains normal size and proximal division performed just distal to pylorus.
16209147|NCT01323114|Other|Conventional Medical Treatment|Standard of care medical treatment for type 2 diabetes to include medications and dietary management under the monitoring of the study endocrinologist.
16209148|NCT01323101|Drug|Doxycycline|Doxycycline 40mg, 100mg, 200mg tablet once daily, or no drug for 28 days.
16209149|NCT01323101|Other|No doxycycline|
16209150|NCT01323088|Other|Control|Standard care control (no exercise)
16209151|NCT01323088|Other|Resistance Exercise|Supervised resistance exercise using stack weight equipments.
16209152|NCT01323088|Other|Aerobic exercise|Supervised aerobic exercise using treadmills, bikes, and ellipticals
16209153|NCT01323075|Procedure|Truncal block|Patients will have a truncal block during hand or wrist surgery.
16209154|NCT01323062|Drug|Bavituximab|Administered 3 mg/kg weekly
16209155|NCT01323049|Procedure|Positive pressure extubation|Positive pressure extubation will be used for patients waking up from general anesthesia
16209156|NCT01323049|Procedure|Aspiration/suction extubation|Aspiration/suction extubation will be used for patients waking up from general anesthesia
16209157|NCT01323036|Dietary Supplement|Krill oil|Krill oil:Total omega-3 fatty acids: 560-660 mg and Astaxanthin: 1800 µg
16209158|NCT01323036|Dietary Supplement|Fish Oil|Fish oil: Total omega-3 fatty acids: 560-660 mg
16209159|NCT01323023|Behavioral|varies by project|
16209160|NCT01323010|Drug|Albuterol - Experimental|The Experimental group will receive higher doses of albuterol in the first hour: 900 mcg (up to 15 kg), 1200 mcg (> 15 to 20 kg), 1500 mcg (> 20 to 25 kg) and 1800 mcg (> 25 kg).
16209161|NCT01323010|Drug|Albuterol - Control|The Control group will receive the following doses of albuterol in the first hour 600 mcg (up to 25 kg) or 1200 mcg (> 25 kg)
16209162|NCT01322997|Device|Myomo e100 Robot and repetitive task specific training|Subjects in this group will be administered about an hour/day of therapy targeting the affected arm. This therapy will include about 1/2 an hour of use of a robot that targets arm function and assists with the movement of the affected arm, and about 1/2 an hour of repetitive task specific training (TRP) using the affected arm.
16209163|NCT01322997|Behavioral|Repetitive task specific training (RTP) targeting the affected arm|Subjects in this group will be administered about an hour/day of therapy targeting the affected arm. This therapy will include consist of repetitive task specific training (RTP) using the affected arm, in which patients use the arm to relearn valued movements using their arms.
16209164|NCT01322997|Device|Myomo e100 neurorobotic brace|Subjects in this group will be administered about an hour/day of therapy targeting the affected arm. Subjects will use a robot that targets arm function and assists with the movement of the affected arm.
16209165|NCT01322984|Behavioral|Pictures|The participants will be exposed to pictures of faces and non-facial stimuli presented on a PC screen.
16209166|NCT01322984|Behavioral|Startle eliciting noise|Startle will be elicited by 95 dB noise, presented at different times after picture onset.
16209167|NCT01322971|Drug|Metronidazole|Metronidazole 500mg orally twice daily for seven days
16209168|NCT01322971|Drug|Placebo|Placebo will be administered orally twice daily for seven days
16209169|NCT01322958|Device|Pelvic Ultrasound|Pelvic ultrasound performed by the emergency physician
16209170|NCT01322919|Procedure|Supracor|"All patients will undergo LASIK treatment on their non-dominant eye with a new laser software algorithm designed to treat both the distance and near vision components.
~The developed software algorithm uses the subjective refraction of the eye to create a treatment for the distance vision correction. This part of the treatment does not show any difference to a regular LASIK treatment for ametropic cases.
~In addition to the treatment for the distance vision a central ablation component will be added to address the near vision."
16209171|NCT01322906|Other|Group 1|Thirty of the enrolled patients were assigned to Group B to receive comprehensive treatment, as well as allogeneic bone marrow mesenchymal stem cells transplantation by peripheral vein(2×105/Kg, once a week, 4 times).
16209172|NCT01322906|Other|Group 2|Thirty of the enrolled patients were assigned to Group B to receive comprehensive treatment, as well as allogeneic bone marrow mesenchymal stem cells transplantation by peripheral vein(1×106/Kg, once a week, 4 times).
16209173|NCT01322906|Other|Group 3|Thirty of the enrolled patients were assigned to Group B to receive comprehensive treatment, as well as allogeneic bone marrow mesenchymal stem cells transplantation by peripheral vein(5×106/Kg, once a week, 4 times).
16209174|NCT01322880|Behavioral|Discussion sessions|Those selected were invited to attend a 6 session course on household decision-making with their spouses. Topics included budgeting, household financial management, and negotiation skills
16209175|NCT01322880|Behavioral|Village Savings and Loans Associations|The approach developed by CARE International develops Village Savings and Loan Associations (VSLAs). A VSLA is a self-selected group of people who pool their money into a fund from which members can borrow. The money is paid back with interest, causing the fund to grow. The regular savings contributions to the Association are deposited with an end date in mind for distribution of all or part of the total funds (including interest earnings) to the individual members, usually on the basis of a formula that links payout to the amount saved. This lump sum distribution provides a large amount of money that members can then use as they want, without restriction.
16209176|NCT01322867|Drug|alprazolam tablet|0,25 mg oral tablets given once
16209177|NCT01322867|Drug|alprazolam oral solution|0,75 mg/ml Oral Solution (Drops) given once
16209178|NCT01322854|Radiation|IMRT with an simultaneous integrated boost|IMRT in 28 fractions delivering 50.4 Gy to the whole breast and 64.4 Gy to the tumor-bed
16209179|NCT01322841|Other|CHICA Diagnosis Module|The CHICA module helped to screen and diagnose patients with tuberculosis or iron deficiency anemia
16209180|NCT01322841|Other|CHICA Placebo|This was CHICA without the screening module
16212780|NCT01293955|Drug|Placebo|placebo of Joins 200mg
16209181|NCT01322828|Procedure|Distal bicep tendon reconstruction|Randomized to either a single incision technique or a double incision technique.
16209182|NCT01322815|Drug|chemotherapy and GI-4000|"Standard chemotherapy and bevacizumab 40YU GI-4000 prior to initiation of chemotherapy and then intercycle 7 days after each chemotherapy cycle for up to 8 cycles.
~maintenance of GI-4000 injection and bevacizumab every 2 weeks"
16209183|NCT01322815|Drug|GI-4000|40 YU GI-4000 every 2 weeks Bevacizumab every 2 weeks
16209184|NCT01322802|Biological|pUMVC3-hIGFBP-2 multi-epitope plasmid DNA vaccine|Given ID
16209185|NCT01322802|Other|laboratory biomarker analysis|Correlative studies
16209186|NCT01322789|Biological|Intravenous Mesenchymal stem cell infusion|Four consecutive intravenous infusions 1 week apart followed by 4 consecutive infusions 1 month apart
16209187|NCT01322776|Drug|Combination of Bortezomib, Fludarabine and Cyclophosphamide|bortezomib 1.3mg/m^2 i.v. on days 1, 4, 8 and 11 of each 28-day cycle fludarabine 25mg/m^2 i.v. on days 1~3 of each 28-day cycle cyclophosphamide i.v. on days 1~2 of each 28-day cycle
16209188|NCT01322737|Procedure|Tissue Access and Resection System|This feasibility trial will assess the effectiveness of SuMO System to create a submucosal pocket and resect the overlying mucosa in excised human colonic or gastric tissue
16209189|NCT01322724|Procedure|Warm vs Cool water|Body vs Room temperature water used during insertion of colonoscopy
16209190|NCT01322711|Drug|Atorvastatin|Atorvastatin 40 mg day
16209191|NCT01322711|Drug|Placebo|Diet
16209192|NCT01322698|Biological|Tests for candidiasis|Tests include (1) anti-candida antibody ELISA kit; (2) candida antigen ELISA kit; (3) detection of circulating Candida DNA via SYBR Breen qPCR Master mix; (4) colonization index based on mycological examination of five out of the following: urine, oral swab, bronchial aspirate, anal swab, swab of a central venous line, gastric liquid.
16209193|NCT01322659|Device|Helmet|Weaning from mechanical ventilation with noninvasive positive pressure ventilation delivered by means of the helmet
16209194|NCT01322659|Device|Endotracheal tube|Weaning from mechanical ventilation with invasive mechanical ventilation delivered by means of the endotracheal tube
16209195|NCT01322646|Device|CarChipPro|On board driving monitor
16209196|NCT01322646|Behavioral|Driver's Education|10 Session License to Learn Program.
16209197|NCT01322646|Behavioral|STEER Program|8-session behavioral parent training and teen social skills/communication training program
16209198|NCT01322646|Other|Driving Simulator Practice|Practice Driving on a driving simulator
16209199|NCT01322633|Other|Does not apply|This is a non-interventional study, therefore the intervention type / name do not apply.
16209200|NCT01322633|Other|Does not apply|This is a non-interventional study, therefore the intervention type / name do not apply.
16209201|NCT01322620|Other|No treatment given|No treatment given. Participants are to complete a questionnarie in the study.
16209202|NCT01322607|Behavioral|High-intensity Treadmill Exercise|High-intensity treadmill walking program
16209203|NCT01322607|Behavioral|Low-intensity Lifestyle Intervention|A low-intensity lifestyle intervention targeted towards group exercises incorporating balance, coordination, and strength.
16209204|NCT01322594|Biological|MEDI2338|MEDI2338 single intravenous (IV) dose (lowest dose)
16209205|NCT01322594|Biological|MEDI2338|MEDI2338 single IV dose (next highest dose)
16209206|NCT01322594|Biological|MEDI2338|MEDI2338 single IV dose (next highest dose)
16209207|NCT01322594|Biological|MEDI2338|MEDI2338 single IV dose (next highest dose)
16209208|NCT01322594|Biological|MEDI2338|MEDI2338 single IV dose (highest dose)
16209209|NCT01322594|Other|Placebo|Placebo single IV dose
16209210|NCT01322503|Biological|Norovirus|Norovirus challenge pool administered to each subject
16209211|NCT01322490|Biological|PROSTVAC-V|
16209212|NCT01322490|Biological|PROSTVAC-F|
16209213|NCT01322490|Drug|GM-CSF|
16209214|NCT01322490|Other|GM-CSF Placebo|
16209215|NCT01322490|Biological|Placebo|PROSTVAC V/F Placebo
16209216|NCT01322477|Other|F18-FDG PET/CT|
16209217|NCT01322464|Drug|Sativex|4 sprays Sativex in fasted state on Day 1. 4 sprays Sativex in fed state on Day 4. 4 sprays Sativex daily in fasted state Days 5-13.
16209218|NCT01322464|Drug|Sativex|4 sprays Sativex in fed state on Day 1. 4 sprays Sativex in fasted state on Day 4. 4 sprays Sativex daily in fasted state Days 5-13.
16209219|NCT01322464|Drug|Sativex|2 sprays Sativex daily in fasted state Days 4-13.
16209220|NCT01322464|Drug|Sativex|8 sprays Sativex daily in fasted state Days 4-13.
16209221|NCT01322451|Drug|GLPG0259 fumarate|single oral dose, two capsules each containing 25 mg of GLPG0259 fumarate
16209222|NCT01322451|Drug|GLPG0259 free base|single oral dose, GLPG0259, 50 mg solid formulation
16209223|NCT01322438|Drug|Regorafenib (BAY73-4506) + rifampin|Drug: BAY73-4506 A single 160-mg dose of BAY73-4506 will be administered in the fasted state on Day 1 as four 40 mg tablets. Drug: BAY73-4506 and rifampin 600 mg once a day doses of rifampin will be orally administered after overnight fasting from Day 15 to Day 23. A single 160-mg dose of BAY73-4506 will be administered in the fasted state on Day 21 as four 40 mg tablets.
16209224|NCT01322399|Procedure|Structural Integration|"Structural Integration (SI) is an alternative method of manual therapy and somato-sensory training that purports to improve biomechanical functioning of the body as a whole rather than to focus on the treatment of specific symptoms. SI therapists employ both manipulation and somatosensory education. SI is delivered in a series of ten treatments, referred to as the Ten Series, each of approximately one hour in duration. The Ten Series protocol includes manipulation of all major joints and anatomical segments. Each of the ten sessions aims to achieve a different set of biomechanical changes, which are regarded as contributing to the progressive approximation of specific ideals of posture and movement."
16209225|NCT01322399|Procedure|Usual care|Usual care in this study consists of the treatment regimen provided for chronic low back pain at Spaulding Medford Rehabilitation clinic, which may include pain medication, exercise and physical therapy. Frequency of treatment averages twice weekly, duration ranges from 3 to 7 weeks
16209226|NCT01322386|Drug|Vancomycin|Oral 50mg/Kg per day up to maximum of 1500 mg a day for three months.
16209227|NCT01322360|Drug|Morphine Sulfate|
16209228|NCT01322347|Drug|Soluble Ferric Pyrophosphate (SFP)|Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 18 months.
16209229|NCT01322347|Device|Standard dialysate|Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week.
16209230|NCT01322334|Behavioral|Singing exercises|A 3 month self-guided treatment based on a specially designed 3CD box set, which patient performed every day ('Singing for Snorers': UK)
16209231|NCT01322321|Drug|ACZ885|
16209232|NCT01322321|Drug|Placebo|
16209233|NCT01322308|Drug|pioglitazone|30 mg tablet QD (taken once daily)
16209234|NCT01322308|Drug|placebo|tablet taken once a day
16209235|NCT01322282|Drug|Cetirizine|A single 10 mg dose of an experimental Cetirizine Orodispersible Tablet (ODT), with a 7-day washout period between visits
16209236|NCT01322282|Drug|Cetirizine|A single 10 mg dose of a marketed Cetirizine Film-Coated Tablet (FCT), with a 7-day washout period between visits
16209237|NCT01322269|Drug|HQK-1001|HQK-1001 tablets, once daily for daily 26 weeks
16209238|NCT01322256|Procedure|Bone scintigraphy|Bone scintigraphy of the affected area
16209239|NCT01322256|Procedure|Leukoscan|Scintigraphy with labeled neutrophils
16209240|NCT01322256|Procedure|PET / CT|PET / CT of the affected area
16209241|NCT01322256|Procedure|Bone biopsy|A bone biopsy is performed during pre-inclusion work up.
16209242|NCT01322256|Biological|Bloodwork|CRP and procalcitonin are measured in the pre-inclusion work up.
16209243|NCT01322243|Other|Dietary manipulation|Participants are maintained in a fasted (only noncaloric beverages) or fed (isocaloric weight-maintenance diet) state for two days.
16209244|NCT01322230|Other|Control|Multimedia Control
16209245|NCT01322230|Other|WISEMD Original|Current WISEMD
16209246|NCT01322230|Other|Social Networking|Social networking feature
16209247|NCT01322230|Other|Social Networking plus Emotional Design|social networking features plus user interface enhancements
16209248|NCT01322204|Drug|Codeine|One single oral dose of 1 mg/kg of codeine
16209249|NCT01322191|Drug|Morphine|A single dose of morphine 0.1 mg/kg infused by syringe pump over 10 minutes; urine and blood sample frozen at -80 degrees Celsius
16209250|NCT01322178|Drug|Cetuximab; mFOLFOX6|"Cetuximab (Erbitux): 500 mg/m2 iv gtt, D1
~Oxaliplatin: 85 mg/m2 iv gtt over 2 hours, D1; leucovorin: 400 mg/m2 iv gtt , D1; 5-FU: 400 mg/m2 iv, 2400 mg/m2 civ46h
~repeated every two weeks for 4.5 months(9 cycles)"
16209251|NCT01322152|Drug|irinotecan, capecitabine|Irinotecan: 90 mg/m2, d1, iv gtt; Capecitabine: 1200mg/m2 Bid, d1-5, po; The regimen is repeated every 7 days.
16209252|NCT01322139|Drug|Placebo spray and oral moxifloxacin placebo|24 or 36 placebo sprays (12 or 18 sprays twice daily every 12 hours) for 5 days and single oral moxifloxacin placebo on Day 5.
16209253|NCT01322139|Drug|Sativex spray and oral moxifloxacin placebo|8 Sativex sprays (4 sprays twice daily every 12 hours) + 16 or 28 placebo sprays (8 or 14 sprays twice daily every 12 hours) for 5 days and single oral moxifloxacin placebo on Day 5.
16209254|NCT01322139|Drug|Sativex spray and oral moxifloxacin placebo|24 or 36 Sativex sprays (12 or 18 sprays twice daily every 12 hours) for 5 days and single oral moxifloxacin placebo on Day 5.
16209255|NCT01322139|Drug|Placebo spray and moxifloxacin|24 or 36 placebo sprays (12 or 18 sprays twice daily every 12 hours) for 5 days and single oral moxifloxacin 400 mg tablet on Day 5.
16209256|NCT01322126|Device|ultrasound probe|we will compare two technique of neuraxial anesthesia;one group will be passed neuraxial anesthesia with the intervention the ultrasound and the other group without the intervention of the ultrasound.
16209257|NCT01322100|Device|The Electroporation System|The Electroporation System comprises of 3 parts: 1.Switch Box, 2. Driver, 3. Brain Probe
16209258|NCT01322100|Drug|Bleomycin|Bleomycin dosage for i.v. use is 15.000 IU/m2, and is administered 10-30 minutes before the electric pulses. Bleomycin dosage for intratumoral use is either 2.000 IU, 4.000 IU, or 6.000 IU per 3 ml, and 20 % of the calculated tumor volume is injected.
16209259|NCT01322087|Dietary Supplement|Nutritional intervention|"The study was a 12 weeks intervention trial with inclusion of 40 patients at nutritional risk, according to the NRS-2002 system.
~All included patients received nutritional counseling and information about the new food concept by a clinical dietician.
~Recording of the dietary intake was carried out on a daily basis over a period of 3 to 7 days, with nutritional registration forms filled in by the nurse and/or the patient."
16209260|NCT01322061|Drug|Ascorbic Acid|Effervescent,1000mg/tablet, 2000 mg dissolved in 50ml water, the drug will be given once, one hour prior to surgery
16209261|NCT01322048|Drug|IV Propranolol and Per Tube Clonidine|1 mg IV q6h Propranolol and 0.1 mg Per Tube Clonidine, both for 7 days
16209262|NCT01322048|Drug|Placebo|Placebo IV q6h and Per Tube q12, both for 7 days
16209263|NCT01322022|Behavioral|ParentTraining|5 sessions of individual parent training
16209264|NCT01322022|Other|Parent Education|Parent Education to control for time and attention
16209265|NCT01322009|Drug|Probenecid and N-acetyl cysteine|After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days or to receive placebos.
16209266|NCT01322009|Drug|Placebo|After obtaining written parental consent, patients will be randomized by the use of a blind envelope system to one of the following: to receive probenecid (initial: 25 mg/kg/dose; maintenance: 10mg/kg/dose 4 x per day for 11 doses) and NAC (initial: 140mg/kg/dose; maintenance: 70mg/kg/dose 6 x per day for 17 doses) or the placebo via nasogastric (NG) or orogastric (OG) tube for 3 days. Placebo contents include equal volumes and dosing regimens of lactose powder (for opacity) suspended in Ora-Plus and normal saline.
16209267|NCT01321996|Procedure|68Ga-DOTA-NOC PET/CT|procedure: PET/CT scan with 68Ga-DOTA-NOC
16209268|NCT01321983|Other|Inspiratory muscular training - IMT|
16209269|NCT01321970|Procedure|Stress ultrasound|Qualitative interpretation of the left ventricular wall motion abnormalities is performed in real time in the resting phase and during pharmacological stress. The translation of quantitative data is then performed for each of the 17 segments on a bulls-eye pattern identical to that of scintigraphy.
16209270|NCT01321970|Procedure|Scintigraphy|Image acquisition is synchronized to the electrocardiogram. The tomographic sections are represented in the 3 directions of space, the analysis is also done on the classical representation in 17 segments. (Typically used in ultrasound perfusion scintigraphy or PET).
16209271|NCT01321970|Procedure|Coronary angiography|"Performed in interventional cardiology setting using a guide introduced through the radial or femoral artery. The injection of iodine allows opacification of coronary arteries and their visualization by fluoroscopy. The qualitative interpretation of the data is translated in terms of percentage of stenosis of the coronary artery. It is thus considered that the stenosis is significant at over 70% obstruction of the lumenal diameter. This interpretation is made for each of the three main coronary arteries and their tributaries:
~Right coronary (proximal, middle and distal) and collateral (inter ventricular posterior ventricular posterior retro)
~Inter ventricular anterior (proximal, middle and distal) and its tributaries (diagonal and septal)
~Circumflex (proximal, middle and distal) and collateral (first and second marginal)"
16209272|NCT01321957|Drug|Oxaliplatin, 5FU/LV, Bevacizumab|bevacizumab at a dose of 5 mg/kg iv over 30 to 90 min (day 1) oxaliplatin at a dose of 85 mg/m2 iv over two hours (day 1) I-LV at a dose of 200 mg/m2 iv over two hours (day 1) 5-FU at a dose of 3200 mg/ m2 iv over 48 hours (day 1-3)
16209273|NCT01321957|Drug|5FU/LV, Oxaliplatin, Bevacizumab, Irinotecan|bevacizumab at a dose of 5 mg/kg iv over 30 to 90 min (day 1) irinotecan at a dose of 165 mg/m2 iv over two hours (day 1) oxaliplatin at a dose of 85 mg/m2 iv over two hours (day 1) I-LV at a dose of 200 mg/m2 iv over two hours (day 1) 5-FU at a dose of 3200 mg/ m2 iv over 48 hours (day 1-3)
16209274|NCT01321944|Other|Direct to Smoker Outreach Program|"Intervention group participants will be sent 3 letters at monthly intervals signed by the participant's PCP, encouraging the smoker to quit, and offering a free telephone consultation by Partners' Tobacco Treatment Coordinator (TTC). Participants can respond to the treatment offer by calling or emailing the TTC, who will provide a 15-minute consultation following the 5A strategy recommended by the US Public Health Service's clinical guideline and help smokers access treatment by (1) offering a free 4-week supply of 21mg nicotine patches sent by secure mailing to their home (refillable once for a total of 8 weeks), (2) helping smokers obtain prescriptions from their PCP for other FDA-approved smoking cessation medication, (3) using a fax-referral system to facilitate connection to free multi-session counseling from the Massachusetts Smokers Quitline, and (4) referring to local in-person counseling programs."
16209275|NCT01321931|Drug|Nicotine|6 mg experimental Nicotine Replacement Therapy (NRT)
16209276|NCT01321931|Drug|Nicotine|4 mg marketed Nicotine Fruit Gum (NFG)
16209277|NCT01321931|Drug|Nicotine|4 mg marketed nicotine mint lozenge (NIQ)
16209278|NCT01321918|Other|Case Controls|A blood sample of 10 ml (2 x 5 ml) on two EDTA tubes will be realised on a route of vascular development place in the context of medical practice.Clinical data will be indicated in the CRF and the computerized database. In the event an eligible patient has not been included during his support by an emergency ambulance service but, after successful resuscitation, he has been hospitalised in a cardiology department, its inclusion may be realised during the hospitalization by a physician investigator of the study. A blood sample of 10 ml of 2 EDTA tubes will be realised on a route of vascular development in the context of routine care.
16209279|NCT01321918|Other|Control subjects|A blood sample of 10 ml (2 x 5 ml) on two EDTA tubes will be realised and clinical data will be indicated in the CRF and the computerized database.
16209280|NCT01321905|Dietary Supplement|Supplementation with vitamin D2/D3|"Patients younger than 16 years of age are administered 35,000 IU ergo-/chole-calciferol per week divided into doses 5000 IU per day as a starting dose that is further adjusted by serum 25-hydroxy vitamin D concentration monitoring. The intervention time is 3 months, followed by 2-months wash-out period when patients do not take any more extra vitamin D but they are still monitored.
~Patients 16 or more years of age are administered 50,000 IU ergo-/chole-calciferol per week divided into doses 7150 IU per day as a starting dose that is further adjusted by serum 25-hydroxy vitamin D concentration monitoring."
16209281|NCT01321879|Drug|Telavancin|10 mg/kg by vein once daily for patients with a creatinine clearance of more than 50 ml/min, and a dose of 7.5 mg/kg once daily for patients with a creatinine clearance of 30-50 ml/min.
16209282|NCT01321866|Procedure|Cutting balloon angioplasty|Angioplasty of fistula stenosis using a cutting balloon
16209283|NCT01321866|Procedure|Angioplasty|Angioplasty of fistula stenosis using a non-cutting balloon
16209284|NCT01321853|Other|MD2 machine and nurse care coordination|MD2 machine filled at least every 2 weeks and subjects monitored for changes in condition. Additional visits made as needed. Care is coordinated with other providers such as the primary care physician and pharmacist.
16209285|NCT01321853|Other|Medplanner and Nurse Care Coordination|Medications are dispensed via a medplanner filled by a nurse at least every 2 weeks and subjects monitored for changes in condition. Additional visits made as needed. Care is coordinated with other providers such as the primary care physician and pharmacist.
16209286|NCT01321840|Procedure|Specific Autoregulation Therapy (SART)|Complex intervention involving acupuncture and hypnotherapeutic techniques after an extensive diagnosis using chinese medical concepts. Patients will receive a maximum of 10 treatments, which are delivered weekly.
16209287|NCT01321827|Drug|Glucocorticoids|Prednisolone 0.5 mg/kg/day for 4 weeks; 0.25 mg/kg/day for 4 weeks; 0.125 mg/kg/day for 4 weeks. Then taper by 5 mg every 2 weeks and discontinue. Patients will also receive inhaled formoterol/fluticasone (6/125 mcg) as needed as per the SMART approach for control of asthma
16209288|NCT01321827|Drug|Itraconazole|Itraconazole 200 mg BD for 6 months along with inhaled formoterol/fluticasone (6/125 mcg) 2 puffs twice daily by MDI and as needed as per the SMART approach
16209289|NCT01321814|Behavioral|Cognitive behavioural therapy|6 sessions by licensed psychologist, including psychoeducation, exposure therapy, applied relaxation and behavioral activation.
16209290|NCT01321801|Drug|Pregabalin|Preoperative administration of pregabalin 600mg
16209291|NCT01321801|Drug|placebo|Preoperative administration of a matching placebo
16209292|NCT01321788|Drug|TINZAPARIN|Eligible women following cesarean section will randomly receive once-daily injections of study drug (4,500 IU tinzaparin sodium within 12 to 24 hours postpartum and continued for two (2) weeks postpartum.
16209293|NCT01321788|Drug|PLACEBO|Eligible women following cesarean section will receive a once-daily injections of placebo within 12 to 24 hours postpartum and continued for two (2) weeks postpartum.
16209294|NCT01321775|Drug|Bevacizumab,Trastuzumab,Paclitaxel,Cyclophosphamide,Myocet|"Neo-adjuvant doses (12 weeks):
~Bevacizumab: 15mg/Kg every 3 weeks Trastuzumab: 4 mg/Kg (First dose) - 2mg/Kg every week. Paclitaxel: 80mg/m2 every week.
~Adjuvant doses:
~Trastuzumab: 8mg/Kg(first dose)- 6mg/Kg every 3 weeks (At least 9 months) Cyclophosphamide: 600mg/m2 every 3 weeks (9 months) Doxorubicin Liposomal: 50mg/m2 every 3 weeks (3 months)"
16209295|NCT01321749|Procedure|Remote ischemic preconditioning (RIPC)|The detail of RIPC included five cycles of bilateral upper limbs 5/5 min. of ischemia and reperfusion alternation. Limb ischemia was induced by inflating tourniquets to 200 mmHg. This process was placed on both arms every day.
16209296|NCT01321736|Dietary Supplement|dietary fiber|mixture of fiber sources added to liquid nutrition product
16209297|NCT01321723|Drug|PTH analog|A recombinant 1-31 amino acid fragment of PTH.
16209298|NCT01321723|Drug|Placebo|
16209299|NCT01321723|Drug|Forsteo (Teriparatide)|A recombinant 1-34 amino acid fragment of PTH.
16209300|NCT01321710|Behavioral|Sleep hygiene|"This intervention consists of behavioral strategies for minimizing maternal arousal and sleep disturbance as a result of night-time infant care. Key components include: infant proximity, low lighting, and noise attenuation.
~It is administered to women during their last month of pregnancy."
16209301|NCT01321710|Behavioral|Dietary information|This intervention consists of dietary information aimed at improving postpartum sleep. The recommendations include avoiding alcohol, caffeine, and heavy meals before bed, as well as eating healthy foods.
16209302|NCT01321710|Drug|Acetaminophen|51-90mg depending on infant weight (12.5mg per kg infant weight). Administered 30 minutes prior to immunization and q4-6h for a total of 5 doses.
16209303|NCT01321697|Procedure|Routine Leg edema and groin dissection|The investigators will be documenting and reporting the variations in leg lymphatic drainage sentinel lymph node biopsy with inguinal-femoral lymph node dissection.
16209304|NCT01321684|Other|lateral decubitus position with full spinal flexion|The patients maintained the lateral decubitus position with the hips and back fully flexed for 15 minutes.
16209305|NCT01321684|Other|lateral decubitus position without spinal flexion|the patients are allowed to straighten their flexed hips and back to obtain the normal lordotic curvature of spinal column
16209306|NCT01321671|Drug|Pregabalin controlled release, 330 mg, 600- 750 calorie|A single oral dose of 330 mg controlled release tablet administered following a 600 to 750 calorie evening meal
16209307|NCT01321671|Drug|Pregabalin controlled release, 330 mg, fasted|A single oral dose of 330 mg controlled release tablet administered fasted in the evening
16209308|NCT01321671|Drug|Pregabalin immediate release, 300 mg|A single oral dose of 300 mg immediate release capsule administered in the evening
16209309|NCT01321658|Other|Geriatric intervention|A comprehensive geriatric assessment (CGA), focusing on co-morbidity, medication, cognitive status, depression, nutritional status and physical status is performed. The intervention is individualized according to the results of the CGA.
16209310|NCT01321645|Drug|Azadirachta Indica|To start with subjects will be prescribed Azadirachta Indica in 6 potency to be taken in form of pills 4 times a day for seven days. Dosage and frequency will be changed, if required, based on the condition of subject and their response according to homoeopathic principles.
16209311|NCT01321632|Drug|Zingiber officinalis|To start with subjects will be prescribed Zingiber officinalis in 6 potency to be taken in form of pills 4 times a day for seven days. Dosage and frequency will be changed, if required, based on the condition of subject and their response according to homoeopathic principles.
16209312|NCT01321619|Drug|Daflon|Drug B (Daflon): Administered one tablet two times daily (oral), the main meals (breakfast and dinner)for 30 days.
16209313|NCT01321619|Drug|Varicell placebo|Drug C (Varicell placebo) : Administered one tablet three times a day,(oral), the main meals (breakfast, lunch and dinner)for 30 days.
16209314|NCT01321606|Dietary Supplement|Lactobacillus rhamnosus HN001|Subjects will be given a pill formulation of a probiotic L. rhamnosus HN001 to be taken once a day, at a dose of 1 x 10^10 organisms
16209315|NCT01321606|Dietary Supplement|sugar pill (placebo)|Placebo identical to the active product will be given
16209316|NCT01321580|Device|Masimo Pronto 7|non invasive hemoglobin determination by the Masimo Pronto 7 versus laboratory hemoglobin measurement
16209317|NCT01321567|Drug|rabeprazole sodium|Doses of 10 mg or 20 mg twice daily may be administered orally to reflux esophagitis patients for a further 8 weeks when proton pump inhibitor treatment is ineffective. However, a dose of 20 mg twice daily should only be administered to patients with severe mucosa injury.
16209318|NCT01321554|Drug|Lenvatinib|Lenvatinib 24 mg (two 10-mg and one 4-mg lenvatinib matched capsules) taken orally once daily, continuously. Dose interruptions or reductions were allowed for subjects who experienced treatment-related toxicity.
16209319|NCT01321554|Drug|Placebo|Matching placebo (two 10-mg and one 4-mg lenvatinib matched capsules) taken orally once daily, continuously.
16209320|NCT01321554|Drug|Lenvatinib|"Lenvatinib 20 mg (two 10-mg capsules) taken orally once daily, continuously. Dose interruptions or reductions were allowed for subjects who experienced treatment-related toxicity.
~The dose of lenvatinib during the OOL Lenvatinib Treatment Period was 24 mg once daily from 03 Oct 2011 until 15 Feb 2013. The dose was lowered at the request of the Data Monitoring Committee to 20 mg on 16 Feb 2013. Thus, more subjects were treated with 24 mg starting dose and the treatment duration was longer for these participants than those whose starting dose was 20 mg."
16209321|NCT01321541|Drug|Pixantrone + Rituximab|Pixantrone + Rituximab: Rituximab 375 mg/m2 IV on day 1 and pixantrone 50 mg/m2 (equivalent to 85mg/m2 pixantrone dimaleate)IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered.
16209322|NCT01321541|Drug|Gemcitabine + Rituximab|Gemcitabine + Rituximab: Rituximab 375 mg/m2 IV on day 1 and gemcitabine 1000 mg/m2 IV on days 1, 8, and 15. Regimen is given in 28-day cycles. Up to 6 cycles may be administered.
16209323|NCT01321515|Drug|famciclovir|500 mg tablet
16209324|NCT01321502|Drug|famciclovir|500 mg tablet
16209325|NCT01321489|Drug|Sildenafil Citrate 20mg Tablet Sublingual|Administer one tablet of Sildenafil Citrate 20 mg sublingually 10 minutes before intercourse. It is recommended that the administration of just one tablet a day. The patient will receive six tablets of the medication.
16209326|NCT01321489|Drug|Viagra ® 50mg tablet Coated|Administer one tablet of Viagra ® 50mg tablet Coated orally 1 hour before intercourse. It is recommended that the administration of just one tablet a day. The patient will receive six tablets of the medication.
16209327|NCT01321463|Drug|PH-797804|6 mg oral tablet once daily for 12 weeks
16209328|NCT01321463|Drug|Placebo|Placebo oral tablet once daily for 12 weeks
16209329|NCT01321437|Procedure|therapeutic conventional surgery|Undergo surgery
16209330|NCT01321437|Other|laboratory biomarker analysis|Correlative studies
16212860|NCT01293123|Drug|Efavirenz|efavirenz 600 mg PO once daily
16209331|NCT01321437|Drug|Axitinib|Axitinib will be administered 5 mg orally twice each day (BID) continuously. Dose adjustments will be based on adverse events.
16209332|NCT01321437|Other|pharmacological study|Correlative studies
16209333|NCT01321411|Other|Near Infrared Spectroscopy|"Healthy Volunteers:
~Study #1 (Abnormal Pulmonary Resistance) subjects will breathe through a Starling resistor simulating abnormal pulmonary resistance. WOB and RMBF will be measured during resting breathing, as well as at 25%, 50% and 75% of MVV.
~Study #2 (Abnormal Pulmonary Compliance) subjects will breathe while wearing a chest binder simulating abnormal pulmonary resistance. WOB and RMBF will be measured during resting breathing, as well as at 25%, 50% and 75% of MVV."
16209334|NCT01321411|Other|Near Infrared Spectroscopy|"Clinical Volunteers:
~Study #3 (Abnormal Pulmonary Resistance) subjects recovering from COPD exacerbations will breathe through their ventilator circuit. PAV support will be altered to change the subjects' WOB. WOB and RMBF will be measured during resting breathing, as well as at 75%, 125% and 150% of baseline WOB.
~Study #4 (Abnormal Pulmonary Compliance) subjects recovering from ARDS will breathe through their ventilator circuit. PAV support will be altered to change the subjects' WOB. WOB and RMBF will be measured during resting breathing, as well as at 75%, 125% and 150% of baseline WOB."
16209335|NCT01321398|Other|Esophageal Pressure Monitoring|An esophageal pressure monitor will be placed through the mouth into the esophagus by a study physician. Placement will be confirmed by a bedside chest X-ray. Once placement has been confirmed all air will be evacuated from the balloon by syringe. One ml of air will then be injected to partially inflate the esophageal balloon. Pleural pressure measurements will be recorded after 1 minute without spontaneous breathing or patient care related movement. This measurement will be repeated at 30 minutes and at 60 minutes after the first measurement. Trans-pulmonary pressure is calculated as the difference between esophageal pressure and mouth pressure. Once the measurements have been recorded, the catheter will be removed.
16209336|NCT01321385|Other|laboratory biomarker analysis|
16209337|NCT01321385|Other|study of socioeconomic and demographic variables|
16209338|NCT01321359|Drug|Vehicle versus NB-001|Topical, 5 times daily until investigator assessment of healing or a maximum of 4 days
16209339|NCT01321346|Drug|Panobinostat|Dose will be assigned at study entry. Patients will take panobinostat orally 3 times a week given on a Monday, Wednesday, Friday schedule, every week. One course is 28 days (4 weeks). Patients will get 2 courses and may receive up to 8 courses total.
16209340|NCT01321346|Drug|Cytarabine|"All patients will receive 70 mg of intrathecal cytarabine on day 0 of course 1. The day 0 dose must be given at least 24 hours prior to initiation of panobinostat. Omit the day 0 dose of intrathecal cytarabine if the patient received intrathecal therapy within 72 hours of treatment.
~All patients will receive 70 mg of intrathecal cytarabine on day 29 of course 1-8 in conjunction with their disease evaluation."
16209341|NCT01321346|Drug|Panobinostat|Dose will be assigned at study entry. Patients will take panobinostat orally 3 times a week on a Monday, Wednesday, Friday schedule, every other week. Once course is 28 days (4 weeks). Patients will get 2 course and may receive up to 8 courses of therapy.
16209342|NCT01321333|Biological|HuCNS-SC cells|single dose intramedullary transplantation of HuCNS-SC cells in the thoracic spinal cord
16209343|NCT01321320|Other|Active muscle stimulation|Neuromuscular Electrical stimulation will be applied to one leg (randomly assigned).
16209344|NCT01321294|Procedure|laparoscopic anti-reflux surgery|
16209345|NCT01321281|Dietary Supplement|AquaCal|"AquaCal and AquaPT are produced by Marigot Ltd according to EU and FDA requirements.
~The daily dose of 4 capsules of AquaCal provide 800mg calcium, (the EU RDA for calcium) and 74 mgs Magnesium (EU RDA 375mg)."
16209346|NCT01321281|Dietary Supplement|AquaPT|"AquaCal and AquaPT are produced by Marigot Ltd according to EU and FDA requirements.
~The daily dose of 4 capsules of AquaPT provides 720mg calcium, 200mgs green tea (polyphenols) and 50 mgs pine bark extract."
16209347|NCT01321268|Dietary Supplement|dietary supplement for cellulite (PUFA, resveratrol, lycopene, beta carotene, lutein)|oral, twice daily in morning and evening for 6 months
16209348|NCT01321268|Dietary Supplement|Viatmin E|oral, twice daily in morning and evening for 6 months
16209349|NCT01321255|Drug|FDC|FDC includes a combination of 100 mg aspirin, 40 mg simvastatin, and 2.5;5;10 mg Ramipril
16209350|NCT01321255|Drug|Separately drugs, simvastatin, aspirin and ramipril|Aspirin 100 mg once a day Ramipril 2.5; 5; 10 mg once a day Simvastatin 40 mg once a day
16209353|NCT01321164|Device|Full Body UV Therapy System UV 7002 plus fumaric acid esters|"Combination therapy of narrow band type B ultraviolet (UVB) therapy plus fumaric acid esters therapy.
~Narrow band UVB therapy: 3 times a week for 6 weeks; Fumaric acid esters therapy: Capsules, schema therapy, 1 to 3 times a day for 6 months"
16209354|NCT01321164|Drug|Fumaric acid esters|Monotherapy, Capsules, schema therapy, 1 to 3 times a day, 6 months
16209355|NCT01321151|Drug|Resveratrol|The dose of resveratrol is 500 mg. The route of administration is oral, once-a-day for 30 days after injury.
16209356|NCT01321151|Drug|Placebo|The placebo is a sugar pill. The route of administration is oral, once-a-day for 30 days after injury.
16209357|NCT01321138|Procedure|Femoral nerve block|The femoral nerve block will be performed with ultrasound 30 minutes before the intervention
16209358|NCT01321138|Procedure|PCA morphine|Postoperative analgesia with self-administration iv morphine
16209433|NCT01320605|Biological|Weekly wound spray with components 1 and 2 of the compound HP802-247|Weekly spray with HP802-247
16209434|NCT01320592|Drug|PD0332991|
16209435|NCT01320592|Drug|Paclitaxel|
16209436|NCT01320579|Drug|Cis-UCA 2.5% emulsion cream|2.5% cis-UCA in emulsion cream base twice daily, amount of a fingertip per one hand (i.e. palm + thumb + fingers) area, applied topically as a thin layer on the affected skin area of approximate size of maximally three hand areas for up to 28 days (one fingertip per one hand area)
16209359|NCT01321125|Biological|Bacterial culture of the prepared skin's areas|Cultures were taken with a scrub-cup of 5cm2 of internal area pressed over the skin previously prepared, then it was added a 3mL of culture broth (C/E neutralizing broth (D/E Neutralizing Broth, DIFCO TM) containing a neutralizing agent and a detergent agent (1% solution tween-80) as washing solution. The skin was scrub with a sterile rubber policeman for 2 minutes, and the procedure was conducted once again. Both aliquots were gathered together in a sterile tube, and a sample of 50mL was spread in a plate containing a neutralizing agar (D/E neutralizing Agar, DIFCO TM) and incubated at 35°C for 72 hrs. After incubation, the colonies were counted.
16209360|NCT01321125|Other|Preparing skin's areas to be tested|Two antiseptics (2% chlorhexidine gluconate in 70% isopropyl alcohol and 10% sodium hypochlorite) and two controls were tested as skin antiseptics. The intervention consisted of preparing four skin's areas with the antiseptic or the control, two in each arm of the volunteer. These ones were approximately 25cm2 on the forearm for each antiseptic or control. The antiseptic or control were applied in an outward circular motion using a swab that was soaked with the solution. The solution was kept on the skin for 60 seconds before the bacterial culture was conducted. Every volunteer were studied in three separate occasions, alternating the four areas in every subsequent test, so every area was studied with each control or antiseptic.
16209361|NCT01321125|Biological|Antiseptic substantivity|Three antiseptics will be tested: 2% chlorhexidine gluconate in 70% isopropyl alcohol, 10% sodium hypochlorite and 10% povidone-iodine, each one will be applied on the surface of one fingertip each, and will be allow to dry for 60 seconds, then the remaining antiseptic on the skin will be wash out with distilled water. The evaluated zones will be dried with sterile gauze, and then will be covered with sterile gauze for two hours. After this period, each finger will be placed for 30 seconds on an agar plate, which will be inoculated whit an ATCC E. coli. The plate will be incubated at 35ºC for 72 hrs. After incubation, a blinded technician will report the presence or absence of bacterial growth
16209362|NCT01321112|Drug|conversion from CNI to MMF|After screening procedure mycophenolate mofetil will be started (week -4) at a dose of 500 mg twice a day for two weeks and then (week -2) increased to 1000 mg twice a day and CNI will be reduced at the 50% of the initial dose. After two weeks (week 0) CNI will be completely discontinued (complete IS conversion). The investigators will follow up patients every 4 weeks up to 48 weeks after the complete IS conversion.
16209363|NCT01321099|Other|NaFeEDTA|Labeled iron as FeSO4 or NaFeEDTA added to a test meal
16209364|NCT01321099|Other|Phytase|Labeled iron as FeSO4 added to a test meal with or without phytase and with or without vitamin C
16209365|NCT01321099|Other|Vitamin C|Labeled iron as FeSO4 added to a test meal with or without vitamin C
16209366|NCT01321086|Behavioral|Motivational Interviewing|9 sessions of MI from baseline to six months
16209367|NCT01321086|Behavioral|PACE|9 sessions of PACE delivered from baseline to six months
16209368|NCT01321073|Device|Model 10642 Implantable Intravascular Catheter|This clinical study consists of the Model 10642 Implantable Intravascular Catheter used in combination with the SynchroMed II Implantable Infusion System (Model 8637) to deliver Remodulin Injection. This study will focus on the safety of delivery of Remodulin Injection in the treatment of patients with PAH who meet the approved Remodulin Injection indication, using the approved formulation, and approved intravenous route of administration.
16209369|NCT01321060|Procedure|Aspiration|
16209370|NCT01321060|Procedure|Catheter drainage|
16209371|NCT01321060|Drug|Conservative treatment|Including antibiotics,somatostatin, proton pump inhibitors and sufficient fluid resuscitation
16209372|NCT01321047|Drug|Propofol|propofol (0.5 mg/kg body weight; 10 mg if age > 70 or ASA class III-IV)
16209373|NCT01321047|Drug|BPS|midazolam (0.05 mg/kg body weight; 1 mg if age > 70 or ASA class III-IV) fentanyl (50 µg; 25 µg if age > 70 or ASA class III-IV) propofol (0.5 mg/kg body weight)
16209374|NCT01321034|Drug|Niacin/Laropiprant|1g/20 mg day of Niacin/Laropiprant for 4-weeks followed by 8 additional weeks of 2 g/40 mg day.
16209375|NCT01321021|Drug|Losartan, Diphenhydramine, Placebo|placebo controlled crossover study with two arms: Losartan 40mg, Diphenhydramine 40mg
16209376|NCT01321008|Radiation|Radiation|50.4 to 54 Gy delivered 5 days a week for 28 to 30 treatments.
16209377|NCT01321008|Drug|Cyclophosphamide|750 mg/m2 by vein over 1 hour on Day 1 of a 21 day cycle.
16209378|NCT01321008|Drug|Doxorubicin|50 mg/m2 by vein over 15 minutes on Day 1 of a 21 day cycle.
16209379|NCT01321008|Drug|Vincristine|1.4 mg/m2 (max dose 2 mg) by vein over 15 minutes on Day 1 of a 21 day cycle.
16209380|NCT01321008|Drug|Prednisone|100 mg by mouth daily on Days 1-5 of a 21 day cycle.
16209381|NCT01320995|Procedure|Perineal ultrasound|Perineal ultrasound is performed after delivery in order to better detect sphincter lesions.
16209382|NCT01320982|Drug|minocycline|minocycline 100 mg/bid
16209383|NCT01320982|Drug|pramipexole|pramipexole 0.125, 0.25, 0.5 and 0.75 mg/bid
16209384|NCT01320982|Drug|acetylsalicylic acid|acetylsalicylic acid 500mg/ bid
16209385|NCT01320982|Drug|placebo|placebo bid
16209386|NCT01320969|Behavioral|Mindfulness-Based Stress Reduction course|an eight-week mindfulness-based stress reduction course
16209387|NCT01320956|Behavioral|Pre operative nurse consultation and Hypnosis|Pre operative nurse consultation with pain management nurse, the day before surgery and 5 to 10 minutes of hypnosis, just before anesthesia, with trained nurse.
16209388|NCT01320956|Other|Pre operative nurse consultation|Pre operative nurse consultation with pain management nurse. Usual care and anesthesia
16209389|NCT01320943|Drug|TDF|Tenofovir disoproxil fumarate (TDF) 300 mg tablet administered orally once daily
16209390|NCT01320943|Other|Stop TDF|Participants will stop TDF therapy
16209391|NCT01320930|Behavioral|Pulmonary rehabilitation|
16209392|NCT01320930|Behavioral|conventional care|
16209393|NCT01320917|Device|Levonorgestrel releasing device|LNG-IUD device releases levonorgestrel in circulation
16209394|NCT01320917|Device|Cu-IUD insertion|The action of a Cu-IUD does not release any hormonal compound
16209437|NCT01320579|Drug|Cis-UCA 5% emulsion cream|5% cis-UCA in emulsion cream base twice daily, amount of a fingertip per one hand (i.e. palm + thumb + fingers) area, applied topically as a thin layer on the affected skin area of approximate size of maximally three hand areas for up to 28 days (one fingertip per one hand area)
16209484|NCT01320228|Dietary Supplement|Capolac+Flax fiber|Allit treatment plus Capolac (1200 mg Ca/d from Capolac) and Flax fiber (5 g dietary fiber from flaxseed)
16209395|NCT01320904|Procedure|NMES|"We used a electrical stimulation device with a 2500-Hz carrier frequency. We used four channels in the synchronous mode, with surface electrodes that were simultaneously fixed at the motor points of the quadriceps and hamstrings. Initially, a warm-up protocol that was five minutes long was used at a stimulation frequency of 40 Hz to activate the slow fibers. These fibers activated with a four-second-contraction time (on), a four-second-stimulus rise time, a four-second-stimulation decay time and a 12-second relaxation time (off).
~We then increased the frequency to 70 Hz to activate the fast fibers for an additional 10 minutes using the parameters described above, and finally, the frequency was increase to 150 Hz for 10 minutes to achieve maximal muscle potentiation."
16209396|NCT01320904|Procedure|Closed Kinetic Chain|During the stimulation period, i.e., the on time, the patient remained in a mini-squat position at thirty degrees and returned to zero degrees during the decay period. During the electrical stimulation off period, the patient spontaneously performed another mini-squat at 30 degrees without electrical stimulation. The patients in the CKC + NMES placebo group simulated the same work applied to the NMES group. Notably, this group was also connected to the electrodes, but the equipment was set at a stimulus intensity of zero.
16209397|NCT01320891|Behavioral|balanced solutions|during the general anaesthesia until 8 o'clock of the day after the operation the subject will receive only balanced fluids that means balanced crystalloid and colloids dissolved in balanced solution. 12 ml /Kg/h during operation time. ratio 3:1 between crystalloid and colloid.
16209398|NCT01320891|Behavioral|not balanced|during the operation time until the 8 o'clock of the day after the operation, the subjects will receive only normal saline and colloid dissolved in normal saline.
16209399|NCT01320878|Drug|iloprost nebuliser solution|iloprost 30 ng/kg/min inhalation for 10 minutes,q4h in day time and q6h at night for 2 days
16209400|NCT01320878|Drug|iloprost nebuliser solution|iloprost 50 ng/kg/min inhalation for 10 minutes, q4h in day time and q6h at night for 2 days
16209401|NCT01320878|Drug|distilled water|distilled water 2 ml per session
16209402|NCT01320852|Other|PET Scan|All patients will have a PET scan as part of their pre-transplant assessment
16209403|NCT01320826|Procedure|colonoscopy|Data pertaining to all colonoscopies performed by a APC-Endo study physician over a two month period will be collected.
16209404|NCT01320813|Procedure|Robot-assisted thyroidectomy|Patients will have a thyroidectomy via a robot-assisted (da Vinci robot) endoscopic (subclavical entry)surgical technique.
16209405|NCT01320813|Procedure|Open thyroidectomy|Patients will have a conventional (non-endoscopic) thyroidectomy using an open surgical technique
16209406|NCT01320800|Behavioral|Skills for Academic and Social Success|12-week cognitive-behavioral, school-based group intervention
16209407|NCT01320800|Behavioral|Skills for Life|SFL is the Skills for Life Protocol delivered by school counselors.
16209408|NCT01320787|Drug|18F-fluoroacetate|18F-fluoroacetate injection as a single intravenous bolus with a maximum volume of 4 mL followed by a saline flush of 20 to 50 mL.
16209409|NCT01320774|Drug|Daivobet® Gel|Once daily on areas with plaque psoriasis, treatment duration up to 8 weeks for body skin areas except scalp (scalp up to 4 weeks), treatment may be repeated under medical surveillance.
16209410|NCT01320761|Drug|ATX-101-BA-free|ATX-101-BA-free
16209411|NCT01320761|Drug|ATX-101-BA|ATX-101-BA
16209412|NCT01320748|Behavioral|Dual Processing|A 10-week, 20-session program, which meets two times per week for 2 hours each time. It is a psychosocial intervention that combines a visual processing (structured drawing activities to engage in sensory-based cue exposure) and a verbal processing component (structured cognitive-behavioral therapy). The treatment focuses on sensory-based emotional expression and cognitive reappraisal and containment strategies that facilitate emotional regulation around a patient's drug and alcohol use experiences.
16209413|NCT01320748|Behavioral|Relapse Prevention|The program's standard care outpatient program is a Relapse Prevention 10-week, 20-session, psychosocial intervention program, which meets two times per week for 2 hours each time. This RP program is based on Gorski's Relapse Prevention model and is a primarily didactic approach.
16209414|NCT01320722|Drug|Vitamin D ergocalciferol|50,000 unit soft gel capsule once per week for 8 weeks
16209415|NCT01320722|Drug|Probenecid|500 mg tablet once per day for 4 weeks, then either 500 mg tablet once per day for 4 weeks or 1000 mg once per day for 4 weeks (8 weeks total)
16209416|NCT01320722|Drug|Allopurinol|300 mg tablet once per day for 4 weeks then either 300 mg once per day or 600 mg once per day for 4 weeks (8 weeks total)
16209417|NCT01320722|Drug|Placebo|Placebo soft gel once per week for 8 weeks
16209418|NCT01320722|Drug|Placebo|Placebo tablet once per day for 4 weeks then twice per day for 4 weeks (eight weeks total)
16209419|NCT01320709|Drug|Piroxicam ( BAYl1902)|Single dose of 20 mg piroxicam (i.e., 1 piroxicam capsule + 3 placebo capsule)
16209420|NCT01320709|Drug|Piroxicam ( BAYl1902)|Single dose of 40 mg piroxicam (i.e., 2 piroxicam capsules + 2 placebo capsule)
16209421|NCT01320709|Drug|Placebo|Single dose of placebo (i.e., 4 placebo capsules)
16209422|NCT01320709|Drug|Piroxicam ( BAYl1902)|Single dose of 80 mg piroxicam (i.e., 4 piroxicam capsules)
16209423|NCT01320696|Biological|Reverse Genetic (RG) reassortant A/H9N2 influenza vaccine|Two intramuscular vaccinations; 5 dose groups: 3.75 µg, 7.5 µg, 15 µg, 30 µg or 45 µg HA antigen (strain A/H9N2/chicken/Hong Kong/G9/97; non-adjuvanted formulation
16209424|NCT01320683|Drug|oxaliplatin|Given IV
16209425|NCT01320683|Drug|leucovorin calcium|Given IV
16209426|NCT01320683|Drug|fluorouracil|Given IV
16209427|NCT01320683|Biological|bevacizumab|Given IV
16209428|NCT01320683|Radiation|yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A|Given IV
16209429|NCT01320683|Other|laboratory biomarker analysis|Correlative studies
16209430|NCT01320683|Other|pharmacological study|Correlative studies
16209431|NCT01320683|Drug|irinotecan hydrochloride|Given IV
16209432|NCT01320657|Device|Conventional orthodontic bracket, passive self-ligating brackets and active self-ligating bracket|"Subjects randomized to treatment with one of three fixed orthodontic appliances: Damon Q, InOvation C and Ovation brackets. A pre-determined archwire sequence will be used involving round nickel titanium, rectangular nickel titanium progressing to 0.019 X 0.025 inch stainless steel; specific archwire sequences and appointment intervals will be based on the manufacturer's guidelines. All erupted teeth will have attachments placed from the outset.
~Treated for a minimum of 8 months with the 0.019 X 0.025 inch stainless steel archwire in place for at least 8 weeks."
16209438|NCT01320579|Drug|Placebo for cis-UCA emulsion cream|The placebo for cis-UCA product (emulsion cream base) twice daily, amount of a fingertip per one hand area applied topically as a thin layer on the affected skin area on of approximate size of maximally three hand areas for up to 28 days (one fingertip per one hand area).
16209439|NCT01320579|Drug|Protopic® 0.1% ointment|0.1% Protopic® twice daily, amount of a fingertip per one hand area applied topically as a thin layer on the affected skin area of approximate size of maximally three hand areas for up to 28 days (one fingertip per one hand area).
16209440|NCT01320566|Device|AeriSeal System|Not applicable. Follow-Up study only.
16209441|NCT01320553|Drug|SPARC1102 I|SPARC1102 I will be administered in both eyes
16209442|NCT01320553|Drug|SPARC1102 II|SPARC1102 II will be administered in both eyes
16209443|NCT01320553|Drug|SPARC1102 III|SPARC1102 III will be administered in both eyes
16209444|NCT01320553|Drug|Vehicle|Vehicle will be administered in both eyes
16209445|NCT01320527|Dietary Supplement|Nutriceutical formulation|Two pills that collectively contain: folic acid (400µg), Vitamin B12 (6µg), Vitamin E (as alpha-tocopherol; 30 IU), S-adenosylmethionine (SAM; 400mg), N-acetyl cysteine (NAC; 600mg) and Acetyl-L-carnitine (ALCAR; 500mg). Taken once daily for duration of study (1 year).
16209446|NCT01320527|Other|Placebo|A mixture of 6 vitamins and nutriceuticals
16209447|NCT01320514|Drug|Fibrin Sealant (Artiss)|
16209448|NCT01320501|Drug|Erlotinib|All patients will receive: TarcevaTM 150mg/day PO.
16209449|NCT01320475|Drug|Sufentanil|Epidural infusion of levobupivacaine (1,25 mg/ml) and sufentanil(1 ml = 50 µg diluted in the 200 ml bag of levobupivacaine) IV infusion of saline (placebo for ketamine)
16209450|NCT01320475|Drug|Ketamine|Epidural infusion of levobupivacaine (1,25 mg/ml) and saline (1 ml = 50 µg diluted in the 200 ml bag of levobupivacaine) IV infusion of ketamine (2 µg/kg/minute) Up to the third postoperative day (6 PM)
16209451|NCT01320462|Drug|Smoking cessation counselling group|The smoking-cessation program has three components; structured preoperative counseling, pharmacotherapy with varenicline for three months, and referral to the quit line (Smokers' Helpline) for proactive telephone counseling and follow up
16209452|NCT01320462|Other|Control group:|Interventions in the control group will be a brief advice regarding smoking cessation and provision of the quit line's information.
16209453|NCT01320449|Drug|recombinant human erythropoietin|rHuEpo (5000 IU)is administered using a small syringe under the skin every other day for the first 2 weeks, on 3 consecutive days during week 3, and once a week from week 4-10.
16209454|NCT01320449|Behavioral|Training|For ten weeks participants will receive supervised endurance training on a bike three times a week. Physical effect will be examined with VO2-max tests before during and after the training period.
16209455|NCT01320449|Other|Placebo|placebo (saline) is administered using a small syringe under the skin every other day for the first 2 weeks, on 3 consecutive days during week 3, and once a week from week 4-12.
16209456|NCT01320436|Dietary Supplement|Curcumin|3 capsules (820 mg containig 500 mg curcumin each) twice daily.
16209457|NCT01320436|Drug|5-aminosalicylic acid|The dosage of 5ASA medication will be the maximum dosage given in this group of patients according to clinical guidelines (4gr' per os + topical 1gr mesalamine
16209458|NCT01320423|Procedure|Surgical Trial|Surgical Trial in Lobar Intracerebral Haemorrhage
16209459|NCT01320410|Drug|ISM®|
16209460|NCT01320397|Drug|Rostafuroxin|6 microgram capsules
16209461|NCT01320397|Drug|Rostafuroxin|50 micrograms capsules
16209462|NCT01320397|Drug|Rostafuroxin|500 micrograms capsules
16209463|NCT01320397|Drug|Losartan|Losartan 50 mg once a day
16209464|NCT01320384|Other|O2 conventional|standard low flow therapy
16209465|NCT01320384|Device|O2-HFN : high flow nasal oxygen therapy|The patient will receive high flow nasal of humidified oxygen, set between 30 to 50 l/min. The inspired fraction of oxygen (FiO2) will be adjusted in order to obtain a SpO2 >92%.
16209466|NCT01320384|Device|O2-HFN/NPPV : association of high flow nasal oxygen therapy and non invasive positive pressure ventilation|The patient will receive successively in a day NPPV and O2-HFN. The NPPV will be applied with an airway humidification achieved by using a heated humidifier and a facial mask adapted to the morphology of the patient. The settings will be adjusted as follow : an inspiratory pressure between 6 to 14 cmH2O, in order to obtain a tidal volume between 7 to 10 ml/kg of predicted weight, a positive expiratory pressure between 0 to 10 cmH2O in order to obtain a SpO2 >92% with the minimal FiO2.
16209467|NCT01320358|Drug|ECMPS-IEM|ECMPS-IEM
16209468|NCT01320345|Drug|Fenofibrate|145 mg tablet of fenofibrate administered once daily for 36 months.
16209469|NCT01320345|Drug|Inert lactose placebo|Insert lactose tablet matching active tablet administered once daily for 36 months.
16209470|NCT01320332|Drug|ASP3291|Oral tablets
16209471|NCT01320332|Drug|Placebo|Oral tablets
16209472|NCT01320319|Other|Placebo|Capsule form, 960 mg to be taken three times a day.
16209473|NCT01320319|Dietary Supplement|Experimental: Nutritional Supplementation with EPA|Capsule form, EPA, 960mg to be taken three times a day.
16209474|NCT01320293|Drug|Adalimumab 40 MG/0.8 ML Subcutaneous Solution [HUMIRA]|40mg subcutaneously, every other week for 6 months
16209475|NCT01320280|Drug|BIBW 2992 (Afatinib)|50 mg BIBW 2992 (Afatinib) tablets daily continuously
16209476|NCT01320267|Procedure|Single port laparoscopic right hemicolectomy|above procedure using Roticulating instruments (from Covidien)
16209477|NCT01320254|Drug|Cisplatin, Gemcitabine, Panitumumab|Cisplatin 25mq/sq.m. at day 1+8 and Gemcitabine 1000mg/sq.m. at day 1 + 8 Panitumumab 9mg/kg BW at day 1
16209478|NCT01320254|Drug|Cisplatin, Gemcitabine|Cisplatin 25mq/sq.m. at day 1+8 and Gemcitabine 1000mg/sq.m. at day 1 + 8
16209479|NCT01320241|Device|self-expandable 125I radioactive seeds-loaded-stent|Patients undergo placement of a self-expandable 125I radioactive seeds-loaded-stent on day 1.
16209480|NCT01320241|Device|self-expandable biliary nitinol alloys stent|Patients undergo placement of a conventional self-expandable biliary nitinol alloys stent on day 1.
16209481|NCT01320228|Dietary Supplement|Control|Alli treatment plus placebo (rice flour)
16209482|NCT01320228|Dietary Supplement|Capolac|Alli treatment plus Capolac supplement (1200 Ca/d from Capolac)
16209483|NCT01320228|Dietary Supplement|Flax fiber|Alli treatment plus flaxseed fibers (5 g/d of dietary fibers from flaxseed)
16213369|NCT01289808|Drug|Glucose 25%|1ml of glucose 25% once
16209485|NCT01320215|Procedure|Robot-assisted promontofixation|Sacrohysteropexy with robotic assistance (da Vinci robot)
16209486|NCT01320215|Procedure|Non-robot assisted promontofixation|Laparoscopic sacrohysteropexy, without robot assistance
16209487|NCT01320202|Drug|Soluble Ferric Pyrophosphate (SFP)|Patients to receive 11 micrograms (µg) of iron/ deciliter (dL) of dialysate during dialysis 3 or 4 times/week for up to 18 months.
16209488|NCT01320202|Device|Standard dialysate|Patients to receive standard dialysate (no iron) during dialysis 3 or 4 times/week.
16209489|NCT01320189|Dietary Supplement|Differences in protein content of meals|Differences in protein content (energy percent) of meals
16209490|NCT01320176|Biological|Investigational HIV vaccine dose A|The vaccine will be administered by intramuscular route into the deltoid muscle preferentially of the non dominant arm at Month 0 and Month 3
16209491|NCT01320176|Biological|Investigational HIV vaccine dose B|The vaccine will be administered by intramuscular route into the deltoid muscle preferentially of the non dominant arm at Month 0 and Month 3
16209492|NCT01320163|Device|i-gel airway (Intersurgical Ltd., Wokingham, England)|supra-glottic airway device
16209493|NCT01320163|Device|Laryngeal Mask Airway|supra-glottic airway device
16209494|NCT01320137|Procedure|Blood withdrawal|Blood sampling
16209495|NCT01320111|Drug|Paclitaxel and Sorafenib|"intravenous solution, 80 mg/sqm, 3 times per cycle, with one cycle = 28 d and application at days 1, 8 and 15
~AND
~pills (200mg), cycle 1: 400 mg / day cycle 2: 600 mg / day from cycle 3: 800 mg / day"
16209496|NCT01320111|Drug|Paclitaxel|intravenous solution, 80 mg/sqm, 3 times per cycle, with one cycle = 28 d and application at days 1, 8 and 15
16209497|NCT01320098|Behavioral|Home-Based Parenting Program|"The Home-Based Parenting Program aims to improve impulsive and oppositional behaviors in 3 and 4 year-olds. The program involves 8 home visits with a therapist. The visits focus on the skills listed below as a means of improving your child's behavior.
~Helping you set developmentally appropriate goals for your child. One way we do this is by focusing on situations that occur naturally in your home. Another way is by having you engage in activities with your child that focus on improving attention and the ability to delay.
~Increasing the quality and quantity of positive interactions between you and your child
~Changing the way you respond to your child's inappropriate behaviors so as to reduce the frequency of negative interactions.
~Improving your parenting skills. This program also includes between-session homework tasks so that you can practice the skills you have learned throughout the week."
16209498|NCT01320098|Behavioral|Clinic-Based Parenting Program|"The Clinic-Based Parenting Program aims to improve ADHD symptoms by reducing noncompliance, which is common in children with ADHD. Parents learn how to help their child attend to and comply with requests and directions so as to improve compliance and attention.
~The program involves 8 clinic visits with a therapist. Parents learn various parenting skills to help improve their child's behaviors.
~Parents learn techniques and skills to promote positive interactions with their child, including:
~Increasing the positive attention you give to your child.
~Reducing the inappropriate use of commands, questions and criticisms.
~Appropriate use of praise and physical attention (e.g., hugs) as rewards.
~Actively ignoring minor, inappropriate behaviors. Parents also learn how to: increase compliance via clear instruction; respond to compliant and noncompliant behaviors; and create and use clear rules about appropriate and inappropriate child behaviors."
16209499|NCT01320098|Behavioral|Wait-List Control Group|If your child is randomized to the 8-week Wait-List group, you and your child will be asked to attend 2 assessment visits -1 screening/baseline visit and one 8 weeks later. These assessment visits will take place at our clinic. After completing the second assessment, you will receive your choice of either the home-based or clinic-based parenting program.
16209500|NCT01320085|Drug|MEK162|
16209501|NCT01320059|Drug|18F-PEG6-IPQA|Radioactive injection (PET imaging agent) given by vein before PET scans.
16209502|NCT01320059|Procedure|Positron emission tomography (PET)|3 PET scans performed after injection and positioning CT. Imaging should take about 3 hours.
16209503|NCT01320046|Other|Questionnaires, gynecological exam , vaginal smear, and measurement of urine leakage|"Patients will undergo the following evaluation:
~Questionnaires- age, medical background, BMI, UI characteristics , usage of pads, other hygiene practices,hormonal therapy, presence of allergic tendency and history etc.
~Medical history.
~Gynecological exam including bladder/rectum/uterine prolapse, vaginal atrophy, discharge, findings of VCD (as part of the usual evaluation in the clinic).
~Vaginal smear: this will be used for vaginal pH measurement and for wet mount, which will assess estrogen deficiency, yeast infection and other inflammatory conditions. Vaginal smears are done as part of the usual evaluation in the clinic.
~Evaluation of the severity of urinary incontinence will be done by collection and weighting of pads during 24 hours."
16209504|NCT01320033|Drug|CD2475/101 40 mg|Participants receive 40 mg of CD2475/101 tablets once a day for 16 weeks.
16209505|NCT01320033|Drug|Doxycycline 100 mg|Participants receive 100 mg of Doxycycline capsule once a day for 16 weeks
16209506|NCT01320033|Drug|Placebo|Participants receive matching placebo tablet, matching placebo capsule once a day for 16 weeks.
16209507|NCT01320020|Drug|catumaxomab|Inter patient dose escalation 2 µg, 4 µg, 7 µg, 10 µg, 14 µg and 19 µg qwk corresponding to dose increments of 100%, 75%, 43%, 40% and 36% respectively of the previous dose
16209508|NCT01320007|Drug|Preset increase in frusemide dose|"All patients in Group 1 will have the Optivol function and alerts switched on. Optivol levels will be downloaded monthly via the Medtronic Carelink Network (for those patients who have it) or during pacemaker follow up appointments.
~If the Optivol alarm goes off, all patients will be requested to contact a member of the research team by phone and those with rising Optivol (irrespective of the presence or absence of heart failure symptoms) will be requested to increase the dose of diuretic that they are on by 50% for 1 week then revert to their usual dose after 7 days. A routine renal function check will be performed at the end of the week."
16209509|NCT01320007|Other|No intervention|The Optivol data for these patients will be downloaded periodically (at each scheduled device check) and recorded but will not be available at follow up in the heart failure clinic.. These patients will act as controls for group 1 patients. They will undergo baseline investigations and then will undergo routine heart failure treatment and follow-up in the heart failure clinic. These will include a routine clinical evaluation, body weight and blood analysis as per the heart failure clinic protocol. Medications will be reviewed and changed according to clinical needs.
16209510|NCT01319994|Drug|Metformin|Metformin 850mg TDS (12 weeks)
16209511|NCT01319994|Drug|Placebo|Placebo 850mg TDS (12 weeks)
16209512|NCT01319981|Drug|Rituximab|In CD20-positive patients, 375 mg/m2 by vein on day 1 and 8 for Courses 1 and 3; and day 1 and 8 of Courses 2 and 4.
16209513|NCT01319981|Drug|Imatinib|600 mg by mouth daily days 1-14 for course 1 and continuously on all other courses for patients who are Philadelphia chromosome positive (Ph+).
16209514|NCT01319981|Drug|Cyclophosphamide|300 mg/m2 by vein over 3 hours every 12 hours x 6 doses days 1, 2, 3 (total dose 1800 mg/m2) for courses 1, 3, 5, 7
16209515|NCT01319981|Drug|Doxorubicin|50 mg/m2 by vein over 24 hours on day 4 after last dose of Cyclophosphamide for courses 1, 3, 5, 7
16209516|NCT01319981|Drug|Mesna|600 mg/m2 by vein continuous infusion daily for 24 hours days 1-3 for courses 1, 3, 5, 7
16209517|NCT01319981|Drug|VSLI|2.0 mg/m2 by vein on day 1 and day 8 for courses 1, 3, 5, 7
16209518|NCT01319981|Drug|Solu-Medrol|40 mg by vein every 12 hours for 6 doses days 1-3 for courses 2, 4, 6, 8.
16209519|NCT01319981|Drug|Methotrexate|200 mg/m2 IV over 2 hrs followed by 800 mg/m2 over 22 hrs on day 1 beginning after the completion of rituximab for Courses 2, 4, 6, and 8.
16209520|NCT01319981|Drug|Ara-C|3 gm/m2 by vein over 2 hours every 12 hours for 4 doses on days 2, 3 for Courses 2, 4, 6, and 8.
16209521|NCT01319981|Drug|G-CSF|10 µg/kg/day (rounded) given subcutaneously until neutrophil recovery to 1 x 10^9/L or higher can be substituted or can be added if neutrophils have not recovered to 1 x 10^9/L by day 21.
16209522|NCT01319981|Drug|Pegfilgrastim|6 mg/kg (rounded) within 72 hrs after completion of chemotherapy.
16209523|NCT01319981|Drug|Dexamethasone|40 mg by vein or by mouth daily days 1-4 and days 11-14 for courses 1, 3, 5, 7
16209524|NCT01319968|Drug|Estriol 0.1% vaginal cream|Patients with both vulvovaginal atrophy (according to cytologic criteria) and dyspareunia will apply 0.5 ml of the cream (0.5 mg) to the vulvar vestibule once daily for one month and will return for check-up visit. In case both atrophy and dyspareunia will resolve, treatment with the cream will be continued 3 times a week.
16209525|NCT01319955|Biological|Trivalent inactivated influenza vaccine|Two doses of 0.25 ml vaccine delivered IM at least 4 weeks apart.
16209526|NCT01319942|Other|Radiotherapy combined with sorafenib|Radiotherapy: 46 Gy to 60 Gy prescribed to involved hepatic tumor Sorafenib: 2 tablet of sorafenib (200mg) twice daily (totally 800mg per day)
16209527|NCT01319929|Drug|LY2828360|Administered orally
16209528|NCT01319929|Drug|Placebo|Administered orally
16209529|NCT01319916|Drug|ATX-101|ATX-101 2mg/cm2
16209530|NCT01319903|Biological|CaCP29, a humanized monoclonal antibody|CaCP29 or placebo single i.v. infusion in ascending doses in healthy human males
16209531|NCT01319890|Procedure|Patients will be divided in two groups- those having right colectomy by standard laparoscopy and those having Single Incision Laparoscopic Surgery (SILS)|Patients will be divided into 2 arms- those with right colon tumors treated by conventional laparoscopic right colectomy and those having a Single Incision Laparoscopic Surgery (SILS)
16209532|NCT01319864|Drug|Plerixafor Dose Escalation|"Plerixafor dose escalation Dose Level -1 = 3 mg/m2/dose Dose Level 1 = 6 mg/m2/dose Dose Level 2 = 9 mg/m2/dose Dose Level 3 = 12 mg/m2/dose Dose Level 4 = 15 mg/m2/dose
~Doses administered 4 hours prior to chemotherapy, then at the same approximate time of day on subsequent days, through the end of that cycle of chemotherapy."
16209533|NCT01319851|Drug|Alefacept|0.25 mg/kg IV on day -40 and day -39 0.5 mg/kg IV on days -33, -26, -19 and -12 Alefacept was diluted in sterile water (2 ml total volume) and administered via i.v. push followed by a normal saline flush per package insert.
16209534|NCT01319838|Drug|Isotretinoin|>12 kg: 160 mg/m2/day, given PO, divided BID <=12 kg: 5.33 mg/kg/day, given PO, dividied BID doses given days 1-14 of 28 day cycle for 24 consecutive cycles
16209535|NCT01319825|Drug|milnacipran|100 mg and 200 mg orally daily for a total of 4 months including a one month titration period.
16209536|NCT01319812|Device|Astron Stents|Implantation of self-expanding, bare-metal, nitinol stents for treatment of peripheral artery disease affecting the iliac artery.
16209537|NCT01319812|Device|Pulsar Stents|Implantation of self-expanding, bare-metal, nitinol stents for treatment of peripheral artery disease affecting superficial femoral or proximal popliteal arteries.
16209538|NCT01319799|Other|Open heart surgery|TCD count of microembolic signals during surgical aortic valve replacement
16209539|NCT01319786|Other|Two portions of fruit and vegetables per day (excluding berries and dark chocolate)|Two portions of fruit and vegetables per day (excluding berries and dark chocolate)
16209540|NCT01319786|Other|Six portions of fruit and vegetables per day (one of which must be berries) and 50g dark chocolate.|Six portions of fruit and vegetables per day (one of which must be berries) and 50g dark chocolate.
16209541|NCT01319773|Drug|cyclosporine ophthalmic emulsion Formulation A|One drop of cyclosporine ophthalmic emulsion Formulation A administered to each eye twice daily for 2 days and once in the morning of Day 3.
16209542|NCT01319773|Drug|cyclosporine ophthalmic emulsion Formulation B|One drop of cyclosporine ophthalmic emulsion Formulation B administered to each eye twice daily for 2 days and once in the morning of Day 3.
16209543|NCT01319773|Drug|cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion 0.05%|One drop of cyclosporine ophthalmic emulsion Formulation A administered to one eye and one drop of cyclosporine ophthalmic emulsion 0.05% administered to the opposite eye, twice daily for 1 day.
16209544|NCT01319773|Drug|cyclosporine ophthalmic emulsion Formulation B; cyclosporine ophthalmic emulsion 0.05%|One drop of cyclosporine ophthalmic emulsion Formulation B administered to one eye and one drop of cyclosporine ophthalmic emulsion 0.05% administered to the opposite eye, twice daily for 1 day.
16209545|NCT01319773|Drug|cyclosporine ophthalmic emulsion Formulation A; cyclosporine ophthalmic emulsion Formulation B|One drop of cyclosporine ophthalmic emulsion Formulation A administered to one eye and one drop of cyclosporine ophthalmic emulsion Formulation B administered to the opposite eye, twice daily for 1 day.
16209546|NCT01319760|Device|Impella 2.5 support|Patients enrolled in the Impella arm will receive 24 hours of post-PCI hemodynamic support using the Impella 2.5
16209547|NCT01319760|Other|Standard of care (Control)|Standard care for STEMI patients post-PCI from ACC/AHA Guidelines
16209548|NCT01319747|Procedure|PVI|For catheter ablation, we used irrigated 4mm RF-ablation catheters, at a maximum power of 30-35Watt, an irrigation rate of 20 mL/min. PV isolation was performed by wide circumferential ablation, encircling all ipsilateral PVs.
16209588|NCT01319513|Other|whey protein pulses|10 2.5 g pulses of whey protein
16209549|NCT01319747|Procedure|VATS-PVI|A bilateral video-assisted thoracoscopic (VATS) pulmonary vein isolation and left atrial appendage (LAA) excision is performed under general anaesthesia and double-lumen endotracheal ventilation.
16209550|NCT01319734|Dietary Supplement|Vitamin C|Vitamin C supplementation 500mg
16209551|NCT01319734|Drug|glyburide|this group receiving glyburide 5 mg alone
16209552|NCT01319721|Procedure|MMC|Intraoperative 0.2mg/ml mitomycin C (0.02%) for 3 minutes will be applied topically after extensive excision of recurrent pterygium.
16209553|NCT01319721|Procedure|LCAG|Limbal conjunctival autograft transplantation will be applied to closure of conjunctival defect after extensive excision of recurrent pterygium.
16209554|NCT01319721|Procedure|AMG|Amniotic membrane graft transplantation will be applied to closure of conjunctival defect after extensive excision of recurrent pterygium.
16209555|NCT01319708|Procedure|mild ovarian stimulation|100-150 mg of clomiphene citrate from day 2 till day 6 of the cycle and 150 mg of gonadotrophins as soon as 1 follicle is more than 14mm together with 1 fixed dose of GnRH antagonist until egg recovery
16209556|NCT01319708|Procedure|conventional ovarian stimulation|300-450 IU of FSH starting by day 2 of menstrual cycle together with a fixed dose of GnRH antagonist starting by day 6 till egg recovery, or same doses with GnRH agonist long protocol
16209557|NCT01319695|Drug|corifollitropin alfa|100 microg for a group of women weighing <or=60 kg and 150 microg for a group of women weighing >60 kg
16209558|NCT01319695|Drug|recombinant follicle stimulating hormone (FSH)|150-300 IU of the drug daily from day 2 of the menstrual cycle until more than 2 follicles are >18mm
16209559|NCT01319682|Drug|Intravenous lidocaine injection|Patients in Group I (intravenous lidocaine injection group) received an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.
16209560|NCT01319682|Drug|Intravenous normal saline injection|The patients in Group C (placebo control group) received normal saline intravenous injection
16209561|NCT01319669|Drug|recombinant human thrombopoietin|Recombinant human thrombopoietin injection in 15000U/ml/amp.
16209562|NCT01319656|Behavioral|Support, management, educational, counselling, follow-up|The project offers a range of activities (educational, counselling, follow-up) by several professionals. The varied range of services is spread out over six months and may include individual or group meetings with professionals. Informational documents and follow-up tools are provided to patients based on their condition, to facilitate the acquisition and maintenance of knowledge, self-management, and changes in risk behaviour.
16209563|NCT01319643|Drug|Oxygen|The lowest inspiratory fraction of oxygen between 21 and 100% in as a short time as possible to maintain SpO2 between 94 and 98% or PaO2 between 70 and 100 mmHg.
16209564|NCT01319630|Device|Sidestream Dark Field (SDF)|"SDF will be applied to the sublingual microvascular network with a 5X objective providing a 167X magnification.
~After the removal of saliva and other secretions using gauze, the device will be gently applied (without any pressure) on the lateral side of the tongue, in an area approximately 1.5-4 cm from the tip of the tongue. Five sequences of 20 secs each from different adjacent areas will be recorded using a computer and a video card and stored under a random number for later analysis. This will be done at baseline and then 1 hour after Fluid bolus."
16209565|NCT01319630|Device|Near Infrared Spectroscopy (NIRS)|Tissue oxygen saturation (StO2) will be measured by a tissue spectrometer, a noninvasive tool, which uses reflectance mode probes to measure scattering light reflected at some distance from where the light is transmitted into the tissue. The NIRS probe will be placed on the skin of the thenar eminence and a sphygmomanometer cuff will be wrapped around the arm over the brachial artery. After a 3-min period to stabilize the NIRS signal, arterial inflow will be stopped (VOT) by inflating the cuff to 50 mmHg above the systolic arterial pressure. After 3 min of ischemia, cuff pressure will be released, and StO2 recorded continuously for another 3 min period (reperfusion period=Reactive Hyperemia).This will be done at baseline and then 1 hour after fluid bolus.
16209566|NCT01319617|Device|SENSIMED Triggerfish|Soft contact lens-based device intended for continuous recording of relative changes in IOP
16209567|NCT01319604|Device|SENSIMED Triggerfish|Soft contact lens-based device for the continuous monitoring of IOP fluctuations
16209568|NCT01319604|Device|Tonometer|Tonometric assessment of IOP
16209569|NCT01319578|Other|K2CG chewing gum|Fasting: Chew gum 15 minutes Post meal: Begin chewing 45 minutes post meal
16209570|NCT01319578|Other|K2CG chewing gum|Fasting: Chew gum 30 minutes Post meal: Begin chewing 30 minutes post meal
16209571|NCT01319578|Other|K2CG chewing gum|Fasting: Chew gum for 45 minutes Post meal: Begin chewing gum 15 minutes post meal
16209572|NCT01319578|Other|K2CG chewing gum|Fasting: Chew gum for 60 minutes Post meal: Being chewing gum 5 minutes post meal
16209578|NCT01319552|Procedure|Fresh transfusion|1 unit autologous transfusion of red blood cells stored for 3-7 days under standard conditions
16209579|NCT01319552|Procedure|Old transfusion|1 unit autologous transfusion of red blood cells stored for 40-42 days under standard conditions
16209580|NCT01319539|Drug|Akt Inhibitor MK2206|Given PO
16209581|NCT01319539|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16209582|NCT01319539|Other|Pharmacological Study|Correlative studies
16209583|NCT01319539|Other|Laboratory Biomarker Analysis|Correlative studies
16209584|NCT01319526|Genetic|DNA analysis|
16209585|NCT01319526|Genetic|RNA analysis|
16209586|NCT01319526|Other|laboratory biomarker analysis|
16209587|NCT01319513|Other|whey protein bolus|single dose of 25 g whey protein
16209589|NCT01319487|Drug|2304 Eye Drops High Dose|2304 Eye Drops High Dose self-administered in the study eye during the treatment period
16209590|NCT01319487|Drug|2304 Eye Drops Low Dose|2304 Eye Drops Low Dose self-administered in the study eye during the treatment period
16209591|NCT01319487|Drug|Placebo Eye Drops|Placebo Eye Drops self-administered in the study eye during the treatment period
16209592|NCT01319474|Other|Whole-leg compression ultrasound|Duplex ultrasound assessment of the venous system of the leg(s) suspected of deep vein thrombosis. Assessment occurs from the most proximal assessable portion of the common femoral vein (usually at the inguinal ligament) to the level of the malleolus.
16209593|NCT01319461|Device|Hyalgan|Patients will receive intraarticular injection of 20mg /2ml /syringe Hyalgan® once a week for 5 consecutive weeks.
16209594|NCT01319461|Device|sterile normal saline|Patients will receive intraarticular injection of sterile normal saline once a week for 5 consecutive weeks.
16209595|NCT01319448|Drug|Proguanil|Proguanil tablets, 1.5mg/kg/day
16209596|NCT01319448|Drug|mefloquine plus artesunate|This treatment is given once a day for 3 days. Patients weighing 5-8 kg receive one paediatric tablet per day, those weighing 9-17 kg two paediatric tablets, those weighing 18-29 kg one adult tablet and those weighing 30 kg and two adult tablets.
16209597|NCT01319448|Drug|Sulfadoxine-pyrimethamine plus amodiaquine|amodiaquine plus sulfadoxine-pyrimethamine supervised at each bimonthly clinic visit (amodiaquine 10mg/kg per day for three days and sulfadoxine-pyrimethamine (25/1.25 mg/kg) on the first day).
16209598|NCT01319435|Procedure|Collection of biological samples|"Sparse blood samples (n=2 or 3 depending on weight) will be drawn on day 1 and day 5- 7 (or last day of treatment if the course is completed before day 7).
~Monitoring of adverse events DNA for pharmacogenetics (scavenged clinical samples or buccal) CSF (if required clinically) Faeces"
16209599|NCT01319422|Drug|Pomalidomide|Comparison of different dosages and schedules of drug
16209600|NCT01319409|Procedure|Anatomic Double-Bundle ACL Reconstruction|Surgical reconstruction of the posterolateral (PL) and anteromedial (AM) bundles of the ACL using an autograft quadriceps tendon with a bone block that is split into 2 free arms to recreate the AM and PL bundles. The bone block is placed in a single femoral tunnel located in the center of the femoral ACL insertion site. The free ends of the graft are be placed in 2 separate tunnels located in the centers of the tibial insertions for the PL and AM bundles. The PL bundle is fixed with the knee in full extension and the AM bundle is fixed with the knee at 45 degrees of flexion.
16209601|NCT01319409|Procedure|Anatomic Single-Bundle ACL Reconstruction|Surgical reconstruction of the ACL using a single autograft quadriceps tendon with a bone block. The free end of the graft is not split. The bone block is placed in a single femoral tunnel located in the center of the femoral ACL insertion site. The single free end of the graft is placed in a single tibial tunnel located in the center of the tibial ACL insertion site. The graft is fixed with the knee in 10 to 20 degrees of flexion.
16209602|NCT01319383|Drug|Vorinostat|Vorinostat (VOR) 400mg will be given as single doses by mouth. Participants eligible to advance in study will have opportunity to receive more than one dose of VOR. Each participant will only take one dose of VOR in a 24 hour period. Repeat doses will be administered at least 24 hours apart, with option for dosing at intervals up to 96 hour
16209603|NCT01319370|Drug|Minoxidil|1 g of 5% Minoxidil topical foam twice daily over 24 weeks in double-blinded phase and further 80 weeks in open-label-phase
16209604|NCT01319370|Drug|vehicle of 5% Minoxidil topical foam|1 g of vehicle topical foam twice daily over 24 weeks in double-blinded phase and further 80 weeks in open-label-phase
16209605|NCT01319357|Drug|Saxagliptin|orally 5 mg/d for 6 weeks
16209606|NCT01319357|Drug|Placebo|orally for 6 weeks
16209607|NCT01319344|Drug|Eplerenone|25 mg o.d. per os
16209608|NCT01319331|Drug|Alpha 1-Antitrypsin (AAT, Aralast NP)|Eligible subjects will be treated once a week for 8 weeks (8 total treatments).
16209609|NCT01319318|Procedure|Pars Plana Vitrectomy|Pars plana vitrectomy performed in study eye on Day 0.
16209610|NCT01319305|Device|FinESS Sinus Treatment|balloon sinuplasty
16209611|NCT01319279|Drug|Hydrocodone bitartrate extended-release tablet|15 mg (single dose)
16209612|NCT01319266|Drug|Hydrocodone Bitartrate extended-release tablet|Hydrocodone bitartrate extended-release oral tablet will be administered at a dose of 45 mg and dosed one time on Day 1. Subjects will also be dosed with naltrexone hydrochloride to block opioid effects.
16209613|NCT01319240|Drug|insulin degludec|Subjects will be randomised to one out of six possible treatment sequences. Single dose, administered subcutaneously (under the skin) on three separate dosing visits.
16209614|NCT01319240|Drug|insulin degludec/liraglutide|Subjects will be randomised to one out of six possible treatment sequences. Single dose, administered subcutaneously (under the skin) on three separate dosing visits.
16209615|NCT01319240|Drug|liraglutide|Subjects will be randomised to one out of six possible treatment sequences. Single dose, administered subcutaneously (under the skin) on three separate dosing visits.
16209616|NCT01319227|Procedure|Hip replacement|Hip arthroplasty with uncemented components
16209617|NCT01319214|Drug|Inderal|Inderal vs. placebo will be administered with or without cocaine cues
16209618|NCT01319188|Drug|0.5 mg of ranibizumab|Intravitreous ranibizumab (0.5 mg, injections at four week intervals for six months followed by further treatment at three month intervals with total duration of treatment until 24 months).
16209619|NCT01319188|Procedure|0.5 mg of ranibizumab + photodynamic therapy|Photodynamic treatment with ranibizumab for predominantly classic type neovascular age related macular degeneration.
16209620|NCT01319188|Other|Sham injection|Sham treatment for occult or minimally classic type neovascular age related macular degeneration.
16209621|NCT01319175|Other|Hip flexion strength training|
16209622|NCT01319162|Other|Weight reduction regimen|The dietary intervention begins with a 12-weeks VLCD/LCD period. The diet comprise of 3 to 5 portions liquid diet with a daily energy intake of 450-800 kcal. In addition, patients will be encouraged to drink 1,5-2L daily of non-caloric beverages (<6 kcal/100 ml). All patients will have scheduled nurse visits at week 0 (baseline), 2, 5, 8, and 12. At these visits general well-being and body weight will be monitored. The patient will also be given support and counselling to enhance compliance to the VLCD/LCD diet.
16209623|NCT01319123|Device|Drawtex dressing|The dressing is indicated for moderately to heavily exuding wounds such as venous leg ulcers
16209671|NCT01318694|Drug|Peginterferon alfa-2a|PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
16209624|NCT01319110|Drug|Coenzyme Q10|Patients will receive CoQ10 200mg three times per day for 7 days, until return to baseline neurologic status, or until death/discharge (whichever comes first). CoQ10 will be given through pre-existing NG or OG tube, and mixed with 20 ml of chocolate Ensure so as to blind investigators and staff.
16209625|NCT01319110|Dietary Supplement|Placebo|Patients will be given Chocolate Ensure via NG/ OG 3x daily as a placebo.
16209626|NCT01319097|Other|Sorbion Sachet S|Dressing is indicated for moderately to heavily exuding wounds.
16209627|NCT01319071|Other|Blood sample|Extraction of blood sample from top-level athletes
16209628|NCT01319058|Procedure|Tonsillectomy, laser tonsillotomy, debrider tonsillotomy|Each arm will be treated by one of the three methods in addition to adenoidectomy
16209629|NCT01319045|Drug|Iloprost|Aerosolized iloprost, 5 mcg/dose x 6 doses daily for 3 months
16209630|NCT01319032|Other|Extraction of whole blood|Extraction of DNA from whole blood
16209631|NCT01319019|Drug|GSK961081|Comparison of different doses and dosing regimens of the drug
16209632|NCT01319019|Drug|Salmeterol|Positive control
16209633|NCT01319019|Drug|Placebo|Placebo arm
16209634|NCT01319006|Drug|GSK1278863A|100mg (x90=13um), oral tablet, single-dose with 7 day wash-out
16209635|NCT01319006|Drug|GSK1278863A|100mg (x90=29um), oral tablet, single-dose with 7 day wash-out
16209636|NCT01319006|Drug|GSK1278863A|100mg (x90=41um), oral tablet, single-dose with 7 day wash-out
16209637|NCT01318993|Drug|GSK1605786A|500 milligrams twice daily
16209638|NCT01318980|Drug|GSK2190915 100mg milled tablet|Taken orally
16209639|NCT01318980|Drug|[14C] radiolabelled GSK2190915 solution|Microtracer solution
16209640|NCT01318980|Drug|GSK2190915 100mg milled tablet administered to the proximal small bowel.|Ground half of a 200mg tablet. Administered via Enterion capsule.
16209641|NCT01318980|Drug|GSK2190915 100mg milled tablet administered to the distal small bowel.|Ground half of a 200mg tablet. Administered via Enterion capsule.
16209642|NCT01318980|Drug|GSK2190915 100mg enteric-coated tablet.|Taken orally
16209643|NCT01318967|Drug|Furosemide|Renal blood flow is measured after the administration of 20 mg of furosemide during MRI scan only.
16209644|NCT01318967|Other|Placebo|
16209645|NCT01318954|Biological|Allergen immunotherapy|
16209646|NCT01318941|Drug|Ranibizumab|
16209647|NCT01318941|Other|Ranibizumab|
16209648|NCT01318928|Drug|Metronidazol|metronidazol. 400mg x 3 per day for 10 days
16209649|NCT01318915|Drug|ATG|1.5 mg/kg IV infusion on day of transplant, and 3 additional on days 2 through 7 after transplant.
16209650|NCT01318915|Drug|Rituximab|375 mg/m^2 IV infusion on day -6 before transplant and on day 1 after transplant.
16209651|NCT01318915|Drug|Tacrolimus|Taken orally. Tacrolimus dose adjusted to maintain target blood levels of 6-10 ng/mL.
16209652|NCT01318915|Drug|Sirolimus|Taken orally. Initial dose, 2 mg daily on day 10 post-transplant, subsequently adjusted to achieve trough levels of 8-12 ng/mL through week 56. Sirolimus withdrawal will be initiated between week 56 and week 88 in eligible participants.
16209653|NCT01318915|Drug|MMF|1 g twice daily on days 0 through 12
16209654|NCT01318902|Drug|Ixazomib|Ixazomib capsules.
16209655|NCT01318902|Drug|Dexamethasone|Dexamethasone tablets.
16209656|NCT01318889|Drug|Dexpanthenol|5% dexpanthenol Mouth wash , three times a day, 10 cc each time
16209657|NCT01318850|Behavioral|Cognitive Remediation Therapy|The program has a duration of 40 sessions (one hour of duration), with two sessions for week during four months. It is carried out individually and utilizes paper and pencil tasks. The main technique utilized is the scaffolding (to provide strategies when the patient cannot carry out the task and to withdraw him when he is yet able of doing it alone) in a context of learning without errors.
16209658|NCT01318850|Behavioral|Psychoeducation|The program has a duration of 40 sessions (one hour of duration), with two sessions for week during four months. It is carried out individually and utilizes teaching information and coping skills and neuropsychological issues are not addressed.
16209659|NCT01318850|Other|Healthy controls|No intervention
16209660|NCT01318837|Drug|solifenacin|oral
16209661|NCT01318824|Procedure|Nasal Intermittent Positive Pressure Ventilation (NIPPV)|The Control group receiving Nasal Intermittent Positive Pressure Ventilation (NIPPV) treatment
16209662|NCT01318824|Procedure|Bi-Level Positive Airway Pressure (BIPAP)|BiPAP group receive Bi-Level Positive Airway Pressure (BIPAP) treatment
16209663|NCT01318811|Drug|Dilute unfractionated heparin|Patients in the dilute heparin arm will receive a systemic loading dose of heparin of 15 units per kilogram of weight by rapid intravenous bolus. Then a maintenance rate of heparin of 7.5 U/Kg per hour will be started. Heparin will be delivered as a solution of 2 units/mL and the infusion will be prepared with 2,000 units of heparin in 1,000 mL of 0.9% NaCl and delivered intravenously proximal to the dialysis filter.
16209664|NCT01318811|Drug|Standard concentration unfractionated heparin|Patients in the standard heparin arm will receive a systemic loading dose of heparin of 15 units per kilogram of weight by rapid intravenous bolus. Then a maintenance rate of heparin of 7.5 U/Kg per hour will be started and delivered in a standard concentration intravenously proximal to the dialysis filter via a syringe. The concentration of heparin used will be 1,000 units of heparin per 1 mL of 0.9% NaCl.
16209665|NCT01318785|Other|Compression Armsleeves|"Type: Compression Class II (according to RAL)
~The study is designed in a way, that per product after a one weak resting (preparing) cycle a 2 weeks wearing period will follow. Herewith the whole duration of the study is 6 weeks per patient."
16209666|NCT01318772|Device|Radiography and Fluoroscopy Imaging System|"KALARE (DREX-KL80) is a new high resolution digital system designed for digital spot imaging, with the primary goal to address R/F and DSA clinical applications and produce images in a digital format.
~The system includes a new digital camera and a new image processor."
16209667|NCT01318746|Procedure|Blood withdrawal|blood withdrawal every 2 hours during 24 hours
16209668|NCT01318733|Drug|CD07805/47 gel 0.5%|In this open-label study, all subjects will receive treatment with CD07805/47 gel 0.5% applied once daily, for up to 12 months.
16209669|NCT01318720|Other|Manual Therapy|Thrust manipulation is a type of manual therapy that clinicians apply using a high-velocity, low-amplitude thrust directed at a joint(s)
16209670|NCT01318694|Drug|Alisporivir|ALV 200 mg soft gel capsules administered orally
16209672|NCT01318694|Drug|Ribavirin|RBV 200 mg tablets (weight-based dose: < 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose
16209673|NCT01318694|Drug|ALV Placebo|ALV placebo soft gel capsules administered orally
16209674|NCT01318681|Drug|cetirizine 10 mg|cetirizine 10 mg over encapsulated
16209675|NCT01318681|Drug|fluticasone furoate|nasal spray 25ug per dose
16209676|NCT01318681|Drug|placebo|a placebo nasal spray and placebo capsule are available for double dummy treatment
16209677|NCT01318668|Biological|vaccination with Nicvax|5 vaccinations of NicVax 400ug (1 ml) over a 18 week period or matching placebo.
16209678|NCT01318655|Drug|NKTR-118|Tablet, Oral, Once daily
16209679|NCT01318655|Drug|Placebo|Tablet, Oral, Once daily
16209680|NCT01318642|Drug|Gemcitabine|Gemcitabine on days 1, 8, and 15, followed by placebo on days 1 and 15 of every 28 day cycle.
16209681|NCT01318642|Drug|AMG 479|Gemcitabine on days 1, 8, and 15, followed by AMG 479 20 mg/kg on days 1 and 15 of every 28 day cycle.
16209682|NCT01318642|Drug|Placebo|Gemcitabine on Days 1, 8, and 15 followed by Placebo 20 mg/kg on days 1 and 15 of every 28 day cycle
16209683|NCT01318616|Other|Strength training of the hip adductors|Adductor strength training
16209684|NCT01318590|Drug|EUS procedure with drug injection|EUS procedure with injection of 10 ml Bupivacaine 0.5% and 40 mg of Triamcinolone in the celiac plexus after administration of intravenous (IV) antibioprophylaxis
16209685|NCT01318590|Other|EUS procedure|EUS procedure without any drug injection
16209686|NCT01318577|Device|Investigational Cleaning & Disinfecting Solution|Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution
16209687|NCT01318577|Device|Clear Care Solution|Contact lenses will be cleaned and stored daily in the cleaning, disinfecting and storage solution
16209688|NCT01318564|Drug|Metformin|500 - 1000 mg by mouth twice a day with either via a MEMS device pill bottle (medication event monitoring system) or by unit-dosing (blister packaging) with attached Med-ic device (electronic compliance monitoring for blistered medication).
16209689|NCT01318564|Behavioral|Questionnaires|Completion on Day 1 and after Month 3. Each questionnaire to take about 30 minutes to complete.
16209690|NCT01318551|Drug|BAY85-3934|single dose, 20 mg
16209691|NCT01318551|Drug|BAY85-3934|single dose, 40 mg (optional)
16209692|NCT01318551|Drug|BAY85-3934|single dose, 80 mg (optional)
16209693|NCT01318538|Behavioral|The Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
16209694|NCT01318538|Behavioral|Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients' self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
16209695|NCT01318525|Drug|ALF-5755|10 mg (25 ml) given in slow intravenous infusion over 10 minutes with an automatic syringe
16209696|NCT01318525|Drug|Saline solution (0.9% NaCl)|25 ml given in slow intravenous infusion over 10 minutes with an automatic syringe
16209697|NCT01318499|Drug|Nepafenac Ophthalmic Suspension, 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days. An additional drop was administered between 30-120 minutes prior to surgery.
16209698|NCT01318499|Drug|Nepafenac Ophthalmic Suspension, 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye once daily, for 16 days. An additional drop was administered between 30-120 minutes prior to surgery.
16209699|NCT01318499|Other|Nepafenac Vehicle 0.3%|Nepafenac Vehicle 0.3%, one drop in affected eye once daily, for 16 days. An additional drop was administered between 30-120 minutes prior to surgery.
16209700|NCT01318486|Other|Heparin free dialysis technique|Saline flushes or predilution
16209701|NCT01318486|Device|Evodial|Evodial dialyer
16209702|NCT01318473|Device|ActiSight™ Needle Guidance System|ActiSight™ Needle Guidance System is comprised of several sub-system components: a computer, a disposable ActiSensor optical sensor, and the disposable ActiSticker, which provides a reference for the insertion of the tool and for the camera.
16209703|NCT01318460|Drug|Levosimendan infusion|Prophylactic 24h infusion of levosimendan at a dose of 0.1 mg/kg/min
16209704|NCT01318460|Drug|Placebo infusion|Twenty-four hour administration of placebo
16209705|NCT01318447|Radiation|CyberKnife SBRT|Dose is 45 Gy (15 Gy in 3 fractions) and delivered over 5 to 10 days.
16209706|NCT01318434|Drug|EB-1010 25mg BID|capsule once daily
16209707|NCT01318434|Drug|SSRI Active|Active Comparator
16209708|NCT01318434|Drug|EB-1010 50mg BID|Experimental Active
16209709|NCT01318434|Drug|Placebo|Placebo comparator
16209710|NCT01318421|Drug|ELND002|
16209711|NCT01318408|Drug|Levetiracetam|Titration of Keppra will start at 250 mg by mouth twice daily for three days. Then 500 mg by mouth twice daily for three days. Then 750 mg by mouth twice daily for the duration of the study, or for as long as treatment is necessary. This titration schedule is subject to change based on subject's tolerability.
16209712|NCT01318395|Drug|Aliskiren|orally 150 mg/d for 1 week, then orally 300 mg/d for 7 weeks
16209713|NCT01318395|Drug|Placebo|orally once per day
16209714|NCT01318382|Device|TOF-Watch SX® Monitoring of NMB|Participants will have the extent of NMB monitored by a TOF-Watch SX®.
16209715|NCT01318369|Drug|Namisol|Single dose delta-9-tetrahydrocannabinol
16209716|NCT01318369|Drug|Diazepam|Diazepam single dose 5mg in subgroup non-opioid users and 10 mg in subgroup opioid users.
16209717|NCT01318356|Behavioral|Cognitive behavioral therapy|CBT will consist of a protocolized intervention of 12 sessions during a period of 24 weeks. It starts with goal setting and psycho-education on the possible role of cognitions and behavior in maintaining the fatigue. The maintaining factors will subsequently be addressed (regulation of sleep-wake cycle, gradual increasing activity, reformulating fatigue related cognitions).
16209718|NCT01318356|Drug|Doxycycline|Antibiotic therapy will consist of doxycycline once daily 200 mg (in 1 capsule) for 24 weeks. Patients will be monitored 4, 8, 16 and 26 weeks after start for side effects (rash, liver enzymes). Antibiotics will be stopped in case of side effects or pregnancy.
16209719|NCT01318356|Drug|Placebo|Patients in the placebo group will receive once daily 1 placebo capsule identical in appearance to the doxycycline for 24 weeks and have the same visits and monitoring for side effects as the patients randomized to doxycycline (Patients will be monitored 4, 8, 16 and 26 weeks)
16209720|NCT01318330|Drug|Homeo-GH|Bone Marraw derived Clonal Mesenchymal Stem Cell (cMSC)
16209721|NCT01318317|Procedure|peripheral blood stem cell transplantation (PBSCT)|Undergo autologous PBSCT
16209722|NCT01318317|Biological|filgrastim|Given IV
16209723|NCT01318317|Genetic|polymerase chain reaction|Correlative studies
16209724|NCT01318317|Biological|rituximab|Given IV
16209725|NCT01318317|Biological|genetically engineered lymphocyte therapy|Receive ex vivo expanded autologous central memory (TCM)-enriched CD8+ T cells expressing CD19-specific chimeric antigen receptor (CAR)
16209726|NCT01318317|Other|laboratory biomarker analysis|Correlative studies
16209727|NCT01318317|Drug|plerixafor|Given IV
16209728|NCT01318317|Procedure|autologous hematopoietic stem cell transplantation|Undergo autologous PBSCT
16209729|NCT01318304|Other|Vaginal lavage specimen|Collection of 3cc of saline used in the vagina to collect innate immunity markers
16209730|NCT01318291|Behavioral|CCRI Group|Cognitive Coping and Relaxation Intervention (CCRI) Cognitive Coping and Relaxation Intervention (CCRI) group who will receive a packet of relaxation and stress management suggestions
16209731|NCT01318291|Behavioral|Control|Medical treatment alone
16209732|NCT01318278|Drug|Dopamine|dopamine at low/medium/and high dose (5, 10, 15, and 20 mcg/kg/min) given IV as a continuous infusion, titrated up for efficacy
16209733|NCT01318278|Drug|Arginine Vasopressin|vasopressin at low/medium/and high dose (0.01, 0.02, 0.03, or 0.04 units/kg/hr) given IV as a continuous infusion, titrated up for efficacy
16209734|NCT01318265|Drug|Regorafenib (BAY73-4506); Regorafenib (BAY73-4506) plus ketoconazole|Treatment 1: A single 160 mg dose of BAY73-4506. Treatment 2: Ketoconazole 400 mg once daily from Day -4 to Day 3. A single 160 mg dose of BAY73-4506 on Day 1.
16209735|NCT01318252|Drug|AL-54478 0.005%|
16209736|NCT01318252|Drug|Latanoprost 0.005%|
16209737|NCT01318252|Drug|AL-54478 Vehicle|Inactive ingredients used as a placebo comparator
16209738|NCT01318239|Procedure|DCE MRI|"MRI and blood test(VEGFR2 signaling assay) will be undergoing at three time points in the patients with Avastin chemotherapy; at baseline (pretreatment), 3 days after Avastin alone treatment, 3 days after Avastin combined chemotherapy (about 10 days after initial Avastin alone treatment).
~MRI and blood test(VEGFR2 signaling assay) will be undergoing at two time points in the patients who will get chemotherapy without antiangiogenic agent; at baseline (pretreatment), 3 days after chemotherapy."
16209739|NCT01318226|Drug|ATx08-001|ATx08-001 will be administered as a 6mm white film coated tablet of 2.5 mg strength, to be taken orally at a dose of 2.5 mg or 7.5 mg, twice a day approximately every 12 hours over an 8 day period.
16209740|NCT01318226|Drug|Placebo|Placebo will be administered as a 6mm white film coated tablet, twice a day approximately every 12 hours over an 8 day period. Placebo is identical in appearance to the ATx 08-001 tablet.
16209741|NCT01318200|Procedure|Transarterial Chemoembolization|Transarterial Chemoembolization will be given within 12 weeks and up to 3 staged procedures, depending on the architecture of the tumor vasculature.
16209742|NCT01318200|Radiation|CyberKnife SBRT|Dose is 45 Gy (15 Gy in 3 fractions) or 36 Gy(12 Gy in 3 fractions). Tumors should receive the higher dose unless normal tissue constraints cannot be met.
16209743|NCT01318187|Drug|paracetamol|1 gr
16209744|NCT01318187|Drug|morphine|0.1mg/kg intravenous in 100 ml serum physiologic
16209745|NCT01318187|Drug|Paracetamol|1 gr intravenous
16209746|NCT01318187|Drug|Paracetamol|intravenous 1 gr
16209747|NCT01318187|Drug|Morphine|0.1 mg/kg intravenous
16209748|NCT01318161|Drug|Ropivacaine + opioid epidurally|Epidural analgesia with local anesthetic + opioid
16209749|NCT01318161|Drug|Morphine|Morphine via PCA pump
16209750|NCT01318148|Drug|caspofungin|Intermittent intravenous application of caspofungin
16209751|NCT01318135|Drug|Alogliptin and glimepiride|Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
16209752|NCT01318135|Drug|Alogliptin and glimepiride|Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.
16209753|NCT01318135|Drug|Alogliptin and metformin|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
16209754|NCT01318135|Drug|Alogliptin and metformin|Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.
16209755|NCT01318122|Drug|Alogliptin and pioglitazone|Alogliptin 12.5 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
16209756|NCT01318122|Drug|Alogliptin and pioglitazone|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 mg or 30 mg, tablets, orally, once daily for up to 40 weeks.
16209757|NCT01318109|Drug|Alogliptin and metformin|Alogliptin 12.5 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
16209758|NCT01318109|Drug|Alogliptin and metformin|Alogliptin 25 mg, tablets, orally, once daily and metformin 250 mg, tablets, orally, twice or three times daily for up 12 weeks.
16209759|NCT01318109|Drug|Metformin|Metformin 250 mg, tablets, orally, twice or three times daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
16209924|NCT01316770|Drug|Dexamethasone Parotid Irrigation|Irrigation of the parotid gland from one side of the mouth with dexamethasone.
16209760|NCT01318096|Drug|raltegravir and tenofovir and lamivudine|raltegravir 400mg BID and tenofovir 300mg qd and lamivudine 300mg gd for 48 weeks
16209761|NCT01318096|Drug|efavirenz+tenofovir+lamivudine|efavirenz 600mg QN +tenofovir 300mg qd +lamivudine 300mg qd for 48 weeks
16209762|NCT01318083|Drug|Alogliptin and glimepiride|Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
16209763|NCT01318083|Drug|Alogliptin and glimepiride|Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.
16209764|NCT01318083|Drug|Glimepiride|Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.
16209765|NCT01318070|Drug|Alogliptin and pioglitazone|Alogliptin 12.5mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
16209766|NCT01318070|Drug|Alogliptin and pioglitazone|Alogliptin 25 mg, tablets, orally, once daily and Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
16209767|NCT01318070|Drug|Pioglitazone|Pioglitazone 15 or 30 mg, tablets orally once daily for up 12 weeks.
16209768|NCT01318044|Drug|Propofol and Thiopental|"An initial bolus of 0.5 mg/kg of propofol will be administered over 1 minute. Supplementary boluses of propofol will be added until the UMSS score 3 are achieved.
~An initial bolus of 2 mg/kg of thiopental will be administered over 1 minute. Supplementary boluses of thiopental will be added until the UMSS score 3 are achieved"
16209769|NCT01318031|Drug|Period 1|Subjects will receive a single 45 mg dose of PF-00299804 on Day 1 of Period 1.
16209770|NCT01318031|Drug|Period 2|Subjects will receive a single 30 mg tablet of paroxetine once daily for 3 days (Days 1 to 3). Then, subjects will be co-administered a 45 mg single dose of PF-00299804 plus a single dose of 30 mg paroxetine on Day 4. Single 30 mg doses of paroxetine will be administered once daily for 6 days (Days 5-10).
16209771|NCT01318005|Drug|Oral Contraceptive: Ortho-Novum® 1/35|Oral Contraceptive: Ortho-Novum® 1/35, pill, 2-3 mos, daily.
16209772|NCT01318005|Drug|Oral Contraceptive: Ovcon® 35|Oral Contraceptive: Ovcon® 35, pill, 2-3 mos, daily.
16209773|NCT01318005|Drug|Oral Contraceptive: Microgestin Fe® 1/20|Oral Contraceptive: Microgestin Fe® 1/20, pill, 2-3 mos, daily.
16209774|NCT01317992|Drug|Ibudilast|Ibudilast 4 x 10 mg capsules, orally, twice daily for 8 weeks.
16209775|NCT01317992|Drug|Placebo|Placebo 4 capsules, orally, twice daily for 8 weeks.
16209776|NCT01317966|Drug|rhIL-11|Recombinant Human Interleukin-11 (rhIL-11) Combinating Low-dose Rituximab
16209777|NCT01317953|Dietary Supplement|epigallocatechin gallate|"Starting dose green tea catechin extract EGCG 400 mg twice a day (BID) of EGCG (400 mg caps BID), second escalated dose 800 mg BID of EGCG (2x400 mg caps BID), third escalated dose 1200 mg BID of EGCG (3x400 mg),fourth escalated dose 1600 mg BID of EGCG (4x400 mg),and fifth escalated dose 2000 mg BID of EGCG (5x400 mg),"
16209778|NCT01317940|Dietary Supplement|Vitamin D and Calcium Citrate|"Vitamin D (10,000 int.units/ml) 100,000 int. units (10ml) by mouth once every two months x 3 times (total treatment period approximately 6-7 months)
~Calcium Carbonate (1,000 mg/tab = 400 mg elemental calcium/tab) 2,000 mg (2 chewable tabs) by mouth every day for approximately 6-7 months"
16209779|NCT01317927|Drug|Belinostat, Warfarin|1000 mg/m2 injection infusion given in a 30 min period plus Warfarin 5mg PO
16209780|NCT01317914|Other|Dietary instruction|Subjects subsequently diagnosed with celiac disease will have gluten-free diet instructions given by registered dietitian experienced in the gluten-free diet. Subjects will have follow-up in 3 months time from initial instruction to verify compliance.
16209781|NCT01317901|Drug|TRU-016|100 mg TRU-016 lyophilized solution for infusion at 10 or 20 mg/kg (or 6 mg/kg, if necessary) on Days 1 and 15 of each 28 day cycle
16209782|NCT01317901|Drug|Bendamustine|Bendamustine by IV administration on Days 1 and 2 of each 28 day cycle.
16209783|NCT01317901|Drug|Rituximab|Rituximab by IV administration at 375 mg/m^2 on Day 2 of each 28 day cycle.
16209784|NCT01317888|Drug|MAB-425 radiolabeled with I-125|MAb425 anti-epidermal growth receptor) and Iodine-125 will be given as an injection for a total of three treatments each separated by one week.
16209785|NCT01317875|Drug|Ruxolitinib|"Starting dose of ruxolitinib for cohort 1 in dose escalation phase - 5mg twice a day (BID)
~Doses will be increased a total of approximately 5mg for successive dosing cohorts based on baseline platelet count"
16209786|NCT01317862|Device|Transcervical foley catheter, Prostaglandins|16 French foley catheter 10mg dinoprostone vaginal insert
16209787|NCT01317849|Drug|Folic Acid|0.8mg
16209788|NCT01317849|Drug|Vitamin B6|10mg
16209789|NCT01317849|Drug|Vitamin B12|500ug
16209790|NCT01317849|Drug|placebo|0.8 mg
16209791|NCT01317849|Drug|placebo|10mg
16209792|NCT01317849|Drug|placebo|500ug
16209793|NCT01317823|Other|Assessment of cervical status|Assessment of cervical status based on Bishop score versus sonographically measured cervical length
16209794|NCT01317797|Drug|namilumab (MT203)|administered three times, subcutaneous in the abdomen
16209795|NCT01317797|Drug|Placebo|administered three times, subcutaneous in the abdomen
16209796|NCT01317784|Device|Rapid tests for HIV, HCV, HBV, and syphilis|Choice of 16 different rapid tests. Only 12 manufacturer and names are shown because some are used with both blood and oral fluid. When they are used on both specimens, they are counted as two tests.
16209797|NCT01317784|Device|HIV/HCV|Choice of 10 different tests for HIV and hepatitis C.
16209798|NCT01317784|Device|HIV/syphilis|Choice of 7 different tests for HIV and syphilis
16209799|NCT01317784|Device|HIV only|Choice of 4 different tests for HIV only.
16209800|NCT01317771|Procedure|Open proximal biceps tendon tenodesis with an EndoButton|Surgical fixation for bicipital pathology
16209801|NCT01317758|Drug|AS03 Adjuvant|Adjuvant/diluent manufactured by GlaxoSmithKline (GSK)
16209802|NCT01317758|Other|Phosphate Buffered Saline (PBS) diluent|Placebo/diluent provided by sanofi pasteur
16209803|NCT01317758|Biological|Sanofi H5N1 Antigen|Subvirion inactivated monovalent influenza A/H5N1 (Hemagglutinin (HA) of A/Indonesia/05/2005) virus vaccine manufactured by sanofi pasteur, at 2 doses levels 21 days apart, administered at 3.75, 7.5, or 15mcg, with either AS03 adjuvant or PBS.
16209804|NCT01317745|Other|Phosphate Buffered Saline (PBS) diluent|Placebo/diluent provided be sanofi pasteur
16209805|NCT01317745|Drug|MF59 Adjuvant|Adjuvant/diluent manufactured by Novartis
16209806|NCT01317745|Biological|H5N1 Antigen|Subvirion inactivated monovalent influenza A/H5N1 (Hemagglutinin (HA) of A/Indonesia/05/2005) virus vaccine manufactured by sanofi pasteur, at 2 doses levels 21 days apart, , administered at 3.75, 7.5, or 15mcg, with either MF59 adjuvant or PBS.
16209807|NCT01317732|Device|MOTIONPOD (TM) measures|It is a study with a single arm. The MOTIONPOD TM measures are compared with simultaneous estimations obtained with the criteria measure (indirect calorimeter) and with existing activity monitors (heart rate monitor POLAR; different accelerometers - rT3 et Actigraph GT3X-, Actiheart, Sensewear Pro2 Armband) After physical fitness evaluation, different activity monitors are set up and the subjects perform a series of standardised activity tasks of different intensities, and well as a 30-min free activity period. Physical activity energy expenditure is measured at the end of each task using a metabolic gas analyser
16209808|NCT01317719|Procedure|Distal Biceps Re-Insertion Surgery|Surgical Repair of the Distal Biceps Tendon
16209809|NCT01317706|Other|Assessment of cervical status|Assessment of cervical status based on Bishop score versus sonographically measured cervical length
16209810|NCT01317693|Device|Low intensity shock waves|1500 shocks, Energy Density - 0.09 mJ/mm2
16209811|NCT01317680|Device|Omnispec model ED1000|Device: Extracorporeal Shockwave Therapy Generator (Omnispec model ED1000) Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites.
16209812|NCT01317680|Device|Sham control|We use the same probe that induces the same sensation on the penis and the same noise yet no energy
16209813|NCT01317667|Biological|RVEc|
16209814|NCT01317654|Other|Observation|Collection of mortality data at 5 years post trial
16209815|NCT01317641|Drug|ODM-201|ODM-201 administered orally daily
16209816|NCT01317628|Behavioral|Tobacco smoke reduction trial intervention program|Both the parents and children will receive 8 times intervention program weekly in first session. The telephone counseling will reduce the child's tobacco smoke exposure every weekly in second session. The interventionist and child jointly select behavioral goals for reducing tobacco smoke exposure for the child to work toward. The goals will be formalized as a written smoke exposure reduction plan for any of four specific behaviors, as relevant to that family: (a) smoking cessation for the child, (b) making the child's primary home smoke-free, (c) making non-home locations smoke-free.
16209817|NCT01317615|Drug|RAD001|Participants started RAD001 treatment with a dose of 5 mg/day once daily. A dose decrease to 5 mg every other day was allowed if tolerability issues arose.
16209818|NCT01317615|Drug|Paclitaxel|Paclitaxel was started at doses of 175 mg/m². Dose reductions of Paclitaxel to 135 mg/m2 was permitted if tolerability issues arose.
16209819|NCT01317615|Drug|Carboplatin|Carboplatin was started at doses of Area under the Curve 5 (AUC 5). Dose reductions of carboplatin to AUC 4 was permitted if tolerability issues arose.
16209820|NCT01317589|Drug|fentanyl|"T = 0
~start methadone 2 x 2,5 mg or fentanyl patch 12 μg/uur
~breakthrough medication: 50 µg fentanyl nose spray or fentanyl stick 400 µg till 6x/day
~T=1
~1 week
~if necessary increase dose strong opioid with 50%
~T=2 3 weeks
~if necessary increase dose strong opioid with 50%
~if necessary decrease dose strong opioid with 30%
~T=3 5 weeks
~if necessary increase dose strong opioid with 50%
~if necessary decrease dose strong opioid with 30%
~T = 4 9 weeks
~if necessary increase dose strong opioid with 50%
~if necessary decrease dose strong opioid with 30%"
16209821|NCT01317589|Drug|methadone|"T = 0
~start methadone 2 x 2,5 mg or fentanyl patch 12 μg/uur
~breakthrough medication: 50 µg fentanyl nose spray or fentanyl stick 400 µg till 6x/day
~T=1
~1 week
~if necessary increase dose strong opioid with 50%
~T=2 3 weeks
~if necessary increase dose strong opioid with 50%
~if necessary decrease dose strong opioid with 30%
~T=3 5 weeks
~if necessary increase dose strong opioid with 50%
~if necessary decrease dose strong opioid with 30%
~T = 4 9 weeks
~if necessary increase dose strong opioid with 50%
~if necessary decrease dose strong opioid with 30%"
16209822|NCT01317576|Behavioral|Exercise intervention|Subjects will be training for 12 week, 3 times a week. Two times a week they will perform a 30 minutes bicycle training. Once a week they will perform a 30 minutes resistance training.
16209823|NCT01317563|Dietary Supplement|Vitamins A, E, C & Selenium|daily dose = Vitamin A 10000 IU (beta carotene), Vitamin E 400 IU, Vitamin C 1200mg, and Selenium 300mcg.
16209824|NCT01317563|Dietary Supplement|Placebo|total daily dose = 1200mg whey protein, 800mg microcrystalline cellulose
16209825|NCT01317550|Drug|Armodafinil|150 mg by mouth once a day for a 10 week cycle.
16209826|NCT01317550|Other|Placebo|Capsules taken by mouth once a day for a 10 week cycle.
16209827|NCT01317550|Drug|Minocycline|100 mg by mouth twice a day for a 10 week cycle.
16209828|NCT01317550|Behavioral|Questionnaires|Completion of symptom questionnaire before chemoradiation, then once a week during Weeks 1-16, takes up to 5 minutes to complete.
16209829|NCT01317537|Other|Electronic personal health record|
16209830|NCT01317524|Dietary Supplement|Homogenized milk|900 mL homogenized milk 2 slices of bread with marmalade 2 pieces of crisp bread
16209831|NCT01317524|Dietary Supplement|Unhomogenized milk|900 mL unhomogenized milk 2 slices of bread with marmalade 2 pieces of crisp bread
16209832|NCT01317524|Dietary Supplement|Skimmed Milk|900 mL skimmed milk 44 g of salted butter 2 slices of bread 2 pieces of crisp bread
16209833|NCT01317511|Dietary Supplement|Protein|Protein drink
16209834|NCT01317498|Other|Standard Care|CD4, liver function and CBC every 6 months
16209835|NCT01317498|Other|Virological Monitoring|Viral Load test every 6 months
16209836|NCT01317485|Procedure|Laparoscopic lavage and drainage|"[CLOSED] The abdominal cavity is irrigated with six litres of warm saline in all four quadrants. At the end of the procedure a Douglas drain is inserted via the right lateral port.
~***This part of the study was closed in 2013 on advice of the data and safety monitoring board due to safety issues"
16209837|NCT01317485|Procedure|Sigmoidectomy with primary anastomosis|[OPEN] Sigmoidectomy is done according to the guidelines of the American Society of Colon and Rectal Surgeons. The distal transsection margin has to be on the proximal rectum, the proximal margin is determined by the absence of wall thickening due to diverticulitis. The type of anastomosis is done according to the preference of the operating surgeon. A loop ileostomy can be fashioned in order to ensure faecal deviation to the discretion of the surgeon.
16209917|NCT01316874|Drug|Valrubicin, 800 mg|Investigator will be responsible for regulating the use of concomitant medications (systemic and/or topical anticholinergic therapy or topical anesthesia) and other medications.
16209838|NCT01317485|Procedure|Sigmoidectomy with end-colostomy|[OPEN] This is a two-stage procedure with the intention to close the colostomy in a second stage. During the primary surgery, only the perforated diseased part must be resected. There is no need of having the distal transsection line on the proximal rectum.
16209839|NCT01317472|Drug|dexlansoprazole|60 mg dexlansoprazole QAM (1 hour AC) for 2 months
16209840|NCT01317472|Drug|Placebo|1 tablet of placebo QAM (1 hour AC) for 2 months
16209841|NCT01317459|Behavioral|Guided self-determination|Group counselling
16209842|NCT01317446|Drug|amine fluoride/stannous fluoride|10 ml qd, oral, topical, 6 months duration
16209843|NCT01317433|Drug|Doxycycline|Doxycycline 100 mg daily per os to start 7 days before Cetuximab for 6 weeks.
16209844|NCT01317433|Drug|Cetuximab|500 mg/m² IV infusion of 60 minutes every 15 days
16209845|NCT01317420|Drug|BI 836845|Intravenous infusion once every three weeks
16209846|NCT01317381|Procedure|Observational|Blood draw
16209847|NCT01317368|Drug|Naropine|"20 mL of 0,75% Naropin is deposited on each side (40 mL in total) in the TAP.
~At the same time 40 mL of saline 0,9% will be deposited subcutaneously as wound infiltration.
~Both procedures is carried out at the end of the surgery while the patient is still anaesthetized and only this once."
16209848|NCT01317368|Drug|Naropine|"20 mL Saline 0,9% is deposited on each side (40 mL in total) in the TAP.
~At the same time 40 mL Ropivacaine 0,75% will be deposited subcutaneously as wound infiltration.
~Both procedures is carried out at the end of the surgery while the patient is still anaesthetized and only this once."
16209849|NCT01317368|Other|Placebo|"20 mL 0,9% Saline is deposited on each side (40 mL in total) in the TAP.
~At the same time 40 mL Saline 0,9% will be given as wound infiltration.
~Both procedures is carried out at the end of the surgery while the patient is still anaesthetized and only this once."
16209850|NCT01317342|Device|Hypothermic oxygenated perfusion (HOPE)|Application of HOPE for 1 hour, perfusion rate 150-300 ml/min, pressure controlled, perfusion pressure < 3 mm Hg, perfusion route portal vein, recirculating system, perfusion volume 2 L, perfusate Institute George Lopez solution (IGL-1), perfusate temperature 4-6 °C, perfusate oxygenation 150-200 mm Hg
16209851|NCT01317329|Other|Clinically prescribed CPAP therapy|CPAP as prescribed by attending physician
16209852|NCT01317303|Procedure|cTBS-PAS25|40 seconds of continuous Theta-burst stimulation, followed by PAS25 which refers to the intervention 'paired-associative stimulation' with peripheral ulnar nerve stimulation followed by TMS to the motor cortex 25 ms after
16209853|NCT01317303|Procedure|cTBS-iTBS|40 seconds of continuous Theta-burst stimulation, followed by 190 seconds of intermittent Theta-burst stimulation
16209854|NCT01317303|Procedure|PAS25|PAS25 refers to the intervention 'paired-associative stimulation' with peripheral ulnar nerve stimulation followed by TMS to the motor cortex 25 ms after.
16209855|NCT01317303|Procedure|iTBS|190 seconds of intermittent theta-burst stimulation
16209856|NCT01317290|Dietary Supplement|n-3 PUFA free olive oil|negative control
16209857|NCT01317290|Dietary Supplement|linseed oil|
16209858|NCT01317277|Behavioral|individualized Texting for Adherence Building (iTAB)|"Behavioral: Psychoeducation
~Participants will also receive daily text messages to evaluate mood and methamphetamine use, but these messages will not remind participants about medication adherence.
~Behavioral: individualized Texting for Adherence Building (iTAB)
~Intervention is designed to send automated text messages to HIV+ persons who are current methamphetamine (METH+) users. Text messages are personalized, automated, real-time text messages. The iTAB intervention is designed to improve adherence to ART medications among HIV+/METH+ persons above and beyond an active comparator group."
16209859|NCT01317277|Behavioral|Psychoeducation|"Behavioral: Psychoeducation
~Participants will also receive daily text messages to evaluate mood and methamphetamine use, but these messages will not remind participants about medication adherence."
16209860|NCT01317264|Other|no β-glucan|daily consumption of non-β-glucan containing milk drinks together with the 3 main meals for 21 days
16209861|NCT01317264|Other|oat β-glucan|daily consumption of 5g of oat β-glucan in the form of milk drinks with the 3 main meals for 21 days
16209862|NCT01317264|Other|barley β-glucan|"daily consumption of 5g β-glucan extracted from the barley-mutant mother Bomi in the form of milk drinks with the 3 main meals for 21 days"
16209863|NCT01317264|Other|mutant-barley β-glucan|"daily consumption of 5g β-glucan extracted from the high β-glucan barely mutant lys. 5.f in the form of milk drinks with the 3 main meals for 21 days"
16209864|NCT01317251|Other|Dietary intervention (without dairy products)|Control diet without dairy products
16209865|NCT01317251|Other|Dietary intervention (high milk content)|Diet with a high content of milk (~1200 mg Ca/d from milk)
16209866|NCT01317251|Other|Dietary intervention (high cheese content)|Diet with a high content of cheese (~1200 mg Ca/d from cheese)
16209867|NCT01317238|Drug|smallpox vaccine CJ-50300|Conventional CJ-50300 2.5 x 100000 pfu/dose vaccination
16209868|NCT01317225|Drug|17 α hydroxyprogesterone caproate|250mg intramuscular (gluteal muscles) biweekly from enrollment until delivery.
16209869|NCT01317225|Drug|Placebo|250 mg intramuscular (gluteal muscles)biweekly from enrollment until delivery.
16209870|NCT01317212|Drug|Peritumoural carboplatin administration.|Peritumoural carboplatin administration by convection-enhanced delivery (CED) through 4 implanted intracranial catheters. Infusions conducted weekly for 4 consecutive weeks.
16209871|NCT01317199|Drug|Muscadine Plus Grape Skin Extract|Phase I: Dose escalation starts at 500mg pills given by mouth once daily for 28 days per cycle
16209872|NCT01317199|Drug|Low-dose MPX|Randomly-assigned participants receive one capsule of drug (500mg MPX) and seven capsules of placebo composed of pulverized rice, once daily for up to 12 cycles (28 days per cycle).
16209873|NCT01317199|Drug|High-dose MPX|Randomly-assigned participants receive 8 capsules of drug (4000mg MPX) once daily for up to 12 cycles (28 days per cycle).
16209874|NCT01317199|Drug|Placebo oral capsule|Randomly-assigned participants receive 8 capsules once daily of placebo composed of pulverized rice for up to 12 cycles (28 days per cycle).
16209918|NCT01316861|Drug|EMS Acarbose|EMS Acarbose 50 mg 3 times a day
16209919|NCT01316861|Drug|Bayer Acarbose|Bayer Acarbose 50 mg 3 times a day
16209920|NCT01316848|Drug|tivozanib|tivozanib 1.5 mg capsule, 2 discrete single doses separated by 6-weeks
16209921|NCT01316822|Drug|ARRY-382, cFMS inhibitor; oral|multiple dose, escalating
16209922|NCT01316809|Drug|AZD8055|Patients will start at 120 mg once daily
16209875|NCT01317160|Device|Intermittent pneumatic compression (IPC)|6 hours IPC, daily, applied to both calves during two weeks post-operatively. The VenaFlow Elite system (Aircast, Vista, California) uses calf cuffs containing two overlapping air chambers located posteriorly on the leg. As the device cycles, the distal chamber inflates to 52 mm Hg over half a second. During the last 0.2 second of this period, the proximal chamber inflates and reaches 45 mm Hg. After six seconds of inflation the cuff deflates, and the cycle is repeated every minute.
16209876|NCT01317147|Procedure|Roux-en-Y gastric bypass (RYGBP)|
16209877|NCT01317134|Device|EndoPAT measurement|EndoPAT (Itamar Medical Ltd, Ceasarea, Isreal) quantifies the endothelium-mediated changes in vascular tone, elicited by a 5-minute occlusion of the brachial artery (using a standard blood pressure cuff). When the cuff is released, the surge of blood flow causes an endothelium-dependent Flow Mediated Dilatation (FMD). The dilatation, manifested as Reactive Hyperemia, is captured by EndoPAT as an increase in the PAT Signal amplitude. A post-occlusion to pre-occlusion ratio is calculated by the EndoPAT software, providing the EndoPAT index. EndoPAT is FDA-cleared and CE-marked.
16209878|NCT01317134|Biological|Blood Test|It is hypothesized that L-arginine/NO-metabolites are altered in pulmonary hypertension depending on disease severity. Moreover, polymorphisms in L-arginine/NO-metabolism modifying factors may influence disease severity. Analysis will be performed following established/published protocols after isolation from whole blood.
16209879|NCT01317108|Drug|CMF Chemotherapy|
16209880|NCT01317095|Device|Sternalock Rigid Fixation|Patients will have their sternum closed by rigid fixation using Sternalock plates.
16209881|NCT01317082|Device|Acupressure|P 6 Pressure Point
16209882|NCT01317069|Drug|Fluorouracil implant|Before the abdomen was closed, fluorouracil implant 1000mg was sprayed evenly on the surface of tumor resection area, and some of the drugs were put into mesenteric root based on the location
16209883|NCT01317030|Device|Contact Lens Wear|Senofilcon A lenses will be rubbed and rinsed with Bausch + Lomb Sensitive Eyes Saline. The lenses will then be placed into Biotrue multi-purpose solution and soaked for at least 10 hours but no more than 24 hours prior to lens insertion into one eye.
16209884|NCT01317030|Device|Contact Lens Wear|Senofilcon A lenses will be rubbed and rinsed each side with Bausch + Lomb Sensitive Eyes Saline just prior to lens insertion into fellow eye.
16209885|NCT01317030|Other|Non-Contact Lens Wear|No intervention
16209886|NCT01317017|Drug|Actimmune|"All subjects will receive one intradermal injections of 0.25ml of IFN-g (Actimmune TM 100 micrograms/0.5ml), in normal appearing skin of both normal volunteers and psoriasis patients.
~Blood will be taken at baseline and day 1. A skin biopsy (6mm punch) will be taken at the injection site 24 hours later.
~Patients will return at one to two weeks for suture removal.
~Clinical assessments done at every visit.
~Patients will also be evaluated at each visit for any adverse events."
16209887|NCT01317004|Drug|Fingolimod|0.5 mg/day oral capsule
16209888|NCT01317004|Drug|Standard MS DMT|Interferon beta 1a or interferon beta 1b or Glatiramer Acetate
16209889|NCT01316991|Dietary Supplement|Chewing Gum|chewing gum will be provided
16209890|NCT01316991|Dietary Supplement|No Gum|no chewing gum will be provided
16209891|NCT01316978|Drug|Ibuprofen|A single 2 x 100 mg dose of an experimental Ibuprofen Fast Melt Orodispersible Tablet administered orally, with a 7-day washout between visits
16209892|NCT01316978|Drug|Ibuprofen|A single 200 mg Nurofen Meltlets Orodispersible Tablet administered orally, with a 7-day washout between visits
16209893|NCT01316978|Drug|Ibuprofen|A single 2 x 100 mg dose of Junior Strength Motrin Chewable Tablet administered orally, with a 7-day washout between visits
16209894|NCT01316965|Behavioral|Multifaceted prevention program HELP(Hospital Elder Life Program)|"A. Structured geriatric consultation will be performed by geriatricians of the MGT(Mobile Geriatric Teams) before surgery, including clinical examination and geriatric assessment
~B. All members of medical and nursing staffs will attend a two hours training session performed by the MGTs and HELP(Hospital Elder Life Program) will be implemented in the surgical wards
~C. On a quarterly basis, all members of medical and nursing staffs and MGTs will gathered to analyze medical records of patients having experienced a postoperative delirium."
16209895|NCT01316952|Drug|Carvedilol immediate release only|All dosages of carvedilol immediate release
16209896|NCT01316952|Drug|Carvedilol extended release only|All dosages of carvedilol extended release
16209897|NCT01316952|Drug|Long acting β-blockers|All dosages of LA propranolol and SA metoprolol
16209898|NCT01316952|Drug|Other α1/β-adrenergic antagonists|i.e., labetalol. All dosages. Excluding carvedilol immediate release and carvedilol extended release.
16209899|NCT01316952|Drug|Short acting Non-selective β-blockers and short acting β1-Selective agents|All dosages of short acting non-selective β-Blockers (Carteolol, Levobunolol, Metipranolol, Nadolol, Penbutolol, Pindolol, Sotalol, Timolol) and short acting β1-Selective agents (Acebutolol, Atenolol, Betaxolol, Bisoprolol, Nebivolol)
16209900|NCT01316952|Other|No β-blocker|No β-blocker within the month prior to the index date
16209901|NCT01316939|Drug|GSK1605786A|GSK1605786A 500 milligrams once daily
16209902|NCT01316939|Drug|Placebo|Placebo
16209903|NCT01316939|Drug|GSK1605786A|GSK1605786A 500 milligrams twice daily
16209904|NCT01316926|Drug|Test formulation|Paroxetine Hydrochloride 25 miligrams (mg) tablet with controlled release (Paxil CR) manufactured by GlaxoSmithKline Inc. - Mississauga - Canada (test formulation)
16209905|NCT01316926|Drug|Reference formulation|Paroxetine Hydrochloride 25 mg tablets with controlled release (Paxil CR) manufactured by SmithKline Beecham (Cork) Limited - Cidra - Puerto Rico (reference formulation)
16209906|NCT01316913|Drug|GSK573719/GW642444 125/25|125/25 mcg once-daily
16209907|NCT01316913|Drug|GSK573719/GW642444 62.5/25|62.5/25 mcg once-daily
16209908|NCT01316913|Drug|GSK573719|125 mcg once-daily
16209909|NCT01316913|Drug|tiotropium bromide|18 mcg once-daily
16209910|NCT01316900|Drug|GSK573719/GW642444 125/25|125/25 mcg once-daily
16209911|NCT01316900|Drug|GSK573719/GW642444 62.5/25|62.5/26 mcg once-daily
16209912|NCT01316900|Drug|GW642444|25 mcg once-daily
16209913|NCT01316900|Drug|tiotropium bromide|18 mcg once-daily
16209914|NCT01316887|Drug|125/25 mcg once-daily GSK573719/GW642444|GSK573719/GW642444
16209915|NCT01316887|Drug|125mcg once-daily GSK573719|GSK573719
16209916|NCT01316887|Drug|Placebo once-daily|inactive
16209923|NCT01316796|Drug|Sodium Nitrite Cream|
16209925|NCT01316770|Drug|Placebo Parotid Irrigation|Irrigation of the parotid gland on the opposite side of the mouth with placebo saline.
16209926|NCT01316757|Biological|cetuximab|Given IV
16209927|NCT01316757|Drug|paclitaxel|Given IV
16209928|NCT01316757|Drug|carboplatin|Given IV
16209929|NCT01316757|Drug|erlotinib hydrochloride|Given PO
16209930|NCT01316757|Other|laboratory biomarker analysis|Correlative studies
16209931|NCT01316744|Drug|ketamine hydrochloride|
16209932|NCT01316744|Other|pharmacogenomic studies|
16209933|NCT01316744|Other|questionnaire administration|
16209934|NCT01316744|Procedure|assessment of therapy complications|
16209935|NCT01316744|Procedure|quality-of-life assessment|
16209936|NCT01316731|Other|Single legged exercise|A single exercise bout that consists of one hour one-legged cycling on a adapted recumbent cycle ergometer at a submaximal rate. The non-exercising leg will serve as control for the exercising leg.
16209937|NCT01316718|Drug|Mesalazine|2g oral granules, once a day for 1 week, then 2g oral granules, twice a day for 11 weeks
16209938|NCT01316718|Drug|Placebo|2g oral granules, once a day for 1 week, then 2g oral granules, twice a day for 11 weeks
16209939|NCT01316692|Other|laboratory biomarker identification and analysis|Correlative studies
16209940|NCT01316692|Procedure|biopsy|Correlative studies
16209941|NCT01316692|Other|immunohistochemistry/tissue microarrays|Correlative studies
16209942|NCT01316692|Genetic|TdT-mediated dUTP nick end labeling assay|Correlative studies
16209943|NCT01316692|Other|mass spectrometry|Correlative studies
16209944|NCT01316653|Behavioral|GROW Healthier|Group sessions that meet once weekly for 3 months (intensive phase) with choice of phone call session as preferred by participant, phone call coaching monthly for 9 months (maintenance phase), and monthly cues to action to use one's built environment for healthy activities for 24 months (sustainability phase)
16209945|NCT01316653|Behavioral|GROW Smarter|Group sessions that meet six times over the course of three years with quarterly newsletters.
16209946|NCT01316627|Behavioral|Crooked Mirror Externalization Therapy|After subjects complete the pre-treatment assessments, the study therapist will meet with participants to design their treatment program. Treatment will be conducted every day for 15 days, Monday through Friday, for 90-minute sessions. In addition, as a part of therapy, subjects will complete homework assignments daily. Intensive CBT for BDD is done in the form of Exposure and Response Prevention (ERP) with either the mirror retraining method or the crooked mirror externalization therapy. This involves prolonged and repeated exposures to images of the perceived defects, and prevention of ritualistic behavior (e.g., camouflaging with cosmetics, skin-picking, etc.).
16209947|NCT01316627|Behavioral|Mirror Retraining Method|After subjects complete the pre-treatment assessments, the study therapist will meet with participants to design their treatment program. Treatment will be conducted every day for 15 days, Monday through Friday, for 90-minute sessions. In addition, as a part of therapy, subjects will complete homework assignments daily. Intensive CBT for BDD is done in the form of Exposure and Response Prevention (ERP) with either the mirror retraining method or the crooked mirror externalization therapy. This involves prolonged and repeated exposures to images of the perceived defects, and prevention of ritualistic behavior (e.g., camouflaging with cosmetics, skin-picking, etc.).
16209948|NCT01316614|Device|FNA with and without a stylet|If the patient agrees to enrollment in the study, the initial stage of the EUS exam will be performed in the usual manner. If a solid lesion that requires FNA is identified, an envelope will be opened which contains a computer generated randomization sequence for all passes. These sequences will be generated by a web-based program at http://www.randomizer.org/form.htm. Passes will be made based on the randomization, either with or without a stylet. Six passes (three with a stylet and three without a stylet) will be performed on solid lesions and four passes (two with and two without a stylet) will be performed on lymph nodes. Additional passes will be made at the discretion of the endosonographer as clinically indicated but will not be included in the data.
16209949|NCT01316601|Drug|QAX567|
16209950|NCT01316588|Other|Plastic adesive drape|Plastic adhesive drape intraoperatively on patients skin around the surgical wound on the chest and bare skin on the leg
16209951|NCT01316588|Other|Microbial Sealant|Microbial sealant intraoperatively on patients skin around the surgical wound on the leg and bare skin on the chest
16209952|NCT01316575|Device|nCPAP|The experimental group will receive nasal CPAP at 10cmH20 for one hour in the Post Anesthetic Care Unit.
16209953|NCT01316575|Device|Low Flow Oxygen|The control group will receive standard therapy of low flow oxygen via simple mask at 8 litres per minute.
16209954|NCT01316549|Drug|Fludarabine|Given as injection
16209955|NCT01316536|Other|provide headphones with music playing|Participants will be provided with music through headphones
16209956|NCT01316536|Other|Sounds|recorded ICU sounds will be provided to participants through headphones
16209957|NCT01316523|Drug|Rituximab|Rituximab 375 mg/m2/wk x 4 weeks, to begin Day 15 of cycle 1. After 4 cycles of therapy if patient does not respond to treatment, the patient will receive a second course of Rituximab.
16209958|NCT01316523|Drug|Lenalidomide|Lenalidomide will be taken at 20 mg daily, days 1-21 of a 28 day cycle, to be continued until the disease progresses, there are too many side effects, or after twelve cycles if the patient responds to treatment.
16209959|NCT01316510|Dietary Supplement|Bifidobacteria infantis|1 billion organisms twice daily either through a feeding tube or by mouth for 6 weeks or until discharge
16209960|NCT01316510|Other|Placebo|Dilute Nutramigen formula
16209961|NCT01316497|Procedure|Remote ischemic preconditioning (RIPC)|RIPC was performed by applying a blood pressure cuff around the child's leg. The cuff was inflated to 40 mmHg above the systolic pressure in 4 cycles of 5 minutes. Every cycle of ischemia was followed by 5 minutes of reperfusion. The first RIPC cycle started after anesthesia induction when invasive arterial blood pressure was monitored. Appropriate cuff size was used choosing between four sizes. For reproducibility RIPC was performed on the right leg with only a few exceptions, when the leg was used for invasive catheters.
16209962|NCT01316497|Procedure|Control|The cuff was applied on the leg without inflation in the control group.
16210005|NCT01316172|Behavioral|5 Cs|education on consultation
16210041|NCT01315795|Drug|Lanreotide Autogel 90 mg and 120 mg|administration of lanreotide sc every 4 weeks (28 days)
16210143|NCT01314885|Drug|Placebo for PH-797804|Single Dose, Oral, Placebo for PH-797804
16209963|NCT01316471|Behavioral|Online Behavioral Intervention|The online behavioral intervention is travel-themed and participants visit 8 destinations (1 per week) designed to take 30 min each to complete. The destinations serve as an online analog for the weekly sessions used when delivering behavioral interventions face-to-face. The 8 child destinations include: 1) education about chronic pain, 2) recognizing stress and negative emotions, 3) relaxation and distraction skills, 4) school, 5) cognitive skills, 6) sleep hygiene and lifestyle, 7) staying active, and 8) relapse prevention. The eight parent destinations include: 1) education about chronic pain, 2) recognizing stress and negative emotions, 3) operant strategies I, 4) operant strategies II, 5) modeling, 6) sleep hygiene and lifestyle, 7) communication, and 8) relapse prevention.
16209964|NCT01316471|Other|Education: Online Patient Education|The purpose of the online patient education group is to control for time, attention, and computer usage. Children and parents will be provided with access to a modified version of the study website that will provide links to information from publicly available educational websites about pediatric chronic pain management. Children and parents will log onto the web program weekly at the same interval as the Online Behavioral Intervention group. Children and parents will be asked to view 3 links each week and then report a few details pertaining to the content of what they viewed.
16209965|NCT01316458|Drug|STI571 (Glivec®)|
16209966|NCT01316445|Drug|nasal Midazolam|Intranasal and buccal administration of the standard IV formulation of midazolam (5mg/mL), administered via a metered dose sprayer at 0.1mL/spray (i.e. 0.5mg/spray). Administration will be via three sprays in each nostril (for nasal) or three sprays between the cheek and the gum per side (for buccal).
16209967|NCT01316432|Drug|Cenderitide|Cenderitide is a novel rationally designed chimeric natriuretic peptide to be administered in this trial as either a subcutaneous injection or infusion.
16209968|NCT01316432|Other|Placebo|Placebo will be administered as a 24-hour SQ infusion
16209969|NCT01316419|Drug|Telmisartan|Telmisartan 40mg or 80mg
16209970|NCT01316419|Drug|amlodipine|amlodipine 5mg or 10mg
16209971|NCT01316406|Drug|ATH008|The subject will be incorporated in the study and randomised to ATH008 cream 3% or 8% or ATH008 cream placebo
16209972|NCT01316393|Other|XER2020|mucoprotective product
16209973|NCT01316380|Drug|placebo|To evaluate efficacy and safety of 2.5 and 5 mcg tiotropium versus placebo delivered via Respimat inhaler
16209974|NCT01316380|Drug|tiotropium 2.5 mcg|To evaluate efficacy and safety of 2.5 and 5 mcg tiotropium versus placebo delivered via Respimat inhaler
16209975|NCT01316380|Drug|tiotropium 5 mcg|To evaluate efficacy and safety of 2.5 and 5 mcg tiotropium versus placebo delivered via Respimat inhaler
16209976|NCT01316367|Behavioral|PRECEDE HPE model|"The model considers the influence of the following three factors on health-related behavior:
~Predisposing: factors influencing the patient's motivation to undertake the behavior to be analyzed or encouraged.
~Facilitators: factors influencing the level of easiness or difficulty the patient and his/her family have in undertaking a given behavior.
~Reinforcing: factors arising after the patient has undertaken the behavior, and which reward or punish it."
16209977|NCT01316367|Behavioral|CHPE|The CHPE model was defined according to the recommendations of the Spanish Ministry of Health National Conference on Diabetes Mellitus, which was complemented by criteria for good care of the Madrid Primary Healthcare Service for the promotion of healthy lifestyles among adults (2004-2007). The model is based on the following aspects: self-monitoring of glycaemic control, physical exercise, diet, weight management, and times of the day when the patient was most vulnerable to overeating, and given improved understanding of the relative effects of certain food choices on blood glucose control, medication adherence and smoking cessation.
16209978|NCT01316354|Other|Bread types|Bread with 50 g available carbohydrate
16209979|NCT01316341|Drug|BI10773|patient to receive a tablet containing high dose BI10773 p.o. plus one placebo
16209980|NCT01316341|Drug|Placebo|patient to receive two placebos
16209981|NCT01316341|Drug|Placebo|patient to receive two placebos
16209982|NCT01316341|Drug|Placebo|patient to receive two placebos
16209983|NCT01316341|Drug|BI10773|patient to receive a tablet containing low dose BI10773 p.o. plus one placebo
16209984|NCT01316315|Drug|Active|A 5 mg single dose given intravenously via syringe pump over 1 minute.
16209985|NCT01316315|Drug|Placebo|Same as active
16209986|NCT01316302|Drug|Pristiq|Flexible dose, 50-100mg QD, for 12 weeks.
16209987|NCT01316302|Drug|Placebo|Matching placebo, taken QD for 12 weeks.
16209988|NCT01316276|Drug|Liposomal amikacin for inhalation|"Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via nebulization.
~590 mg of liposomal amikacin for inhalation is administered once daily using the PARI Investigational eFlow® Nebulizer.
~Administration time is approximately 13 minutes.
~Liposomal amikacin for inhalation will be administered in two consecutive extension periods, each consisting of 6 cycles for a total of 12 cycles. Each cycle consists of 28 days on-treatment followed by 28 days off-treatment."
16209989|NCT01316263|Biological|Olaratumab|Administered IV
16209990|NCT01316250|Drug|Nilotinib|Nilotinib 300 mg orally twice per day for 12 months followed by imatinib mesylate at a dose of 400 mg orally daily
16209991|NCT01316237|Drug|GS-6620|GS-6620 tablet, 50 mg QD
16209992|NCT01316237|Drug|GS-6620|GS-6620 tablet, 100 mg QD
16209993|NCT01316237|Drug|GS-6620|GS-6620 tablet, 300 mg QD
16209994|NCT01316237|Drug|GS-6620|GS-6620 tablet, 100 mg QD, Fasted
16209995|NCT01316237|Drug|GS-6620|GS-6620 tablet, 300 mg QD, Fasted
16209996|NCT01316237|Drug|GS-6620|GS-6620 tablet, 900 mg QD, Fasted
16209997|NCT01316237|Drug|GS-6620 tablet, 450 mg BID|GS-6620 tablet, 450 mg BID
16209998|NCT01316237|Drug|GS-6620 tablet|GS-6620 tablet, 900mg , BID
16209999|NCT01316237|Drug|GS-6620 tablet|GS-6620 tablet, 900 mg
16210000|NCT01316211|Device|Implantation of coflex™ after surgical decompression|The device will be implanted after surgical decompression in patients with spinal stenosis.
16210001|NCT01316211|Procedure|Surgical decompression|Surgical decompression in patients with spinal stenosis without stabilization by an additional implant
16210002|NCT01316198|Dietary Supplement|Verum|10 subjects consume for 4 weeks a beverage containing 10 mg lutein and 3 mg zeaxanthin per day
16210003|NCT01316198|Dietary Supplement|Placebo|10 subjects consume for 4 weeks a placebo beverage without any lutein and zeaxanthin
16210004|NCT01316185|Drug|EBP921|Patients randomized to receive low or high dose. All dosing of EBP921 should be taken with food.
16210006|NCT01316146|Drug|CAR.CD30 T cells|"Three dose levels will be evaluated:
~Group One, 2x10^7 cells/m^2
~Group Two, 1x10^8 cells/m^2
~Group Three, 2x10^8 cells/m^2;
~Cell Administration: CAR+ ATL will be given by intravenous injection over 1-10 minutes through either a peripheral or a central line. The expected volume will be 1-50cc."
16210007|NCT01316133|Drug|tacrolimus|oral
16210008|NCT01316120|Other|Compare different self-obtained specimen for HPV identification|Instructions will be given to the patients by a research nurse and ICF will be obtained. For specimen collection, participants will be instructed to wash their hands before the procedure. Each participant will receive a package containing a specimen collection kit. Recommendations will be to hold the swab by the end of the handle, to insert the swab into the vagina avoiding contact with the external genitalia, rotate 1 round and to replace the swab in a plastic sleeve (v-DRY) or in a tube containing specimen transport medium (v-STM),.
16210009|NCT01316120|Other|Compare different self-obtained specimen for HPV identification|Instructions will be given to the patients by a research nurse and ICF will be obtained. For specimen collection, participants will be instructed to wash their hands before the procedure. Each participant will receive a package containing a specimen collection kit. Recommendations will be to hold the swab by the end of the handle, to insert the swab into the vagina avoiding contact with the external genitalia, rotate 1 round and to replace the swab in a plastic sleeve (v-DRY) or in a tube containing specimen transport medium (v-STM),.
16210010|NCT01316107|Drug|ipragliflozin|oral
16210011|NCT01316107|Drug|nateglinide|oral
16210012|NCT01316094|Drug|ASP1941|oral
16210013|NCT01316094|Drug|placebo|oral
16210014|NCT01316081|Dietary Supplement|Vitamin C Vitamin E Selenvital all from Burgerstein Vitamine|"Vitamin C: 500mg Vitamin E: 400 I.U. Selenium: 50mcg
~Placebo Supplements: identical appearing tablets"
16210015|NCT01316068|Drug|intravenous use of sulodexide followed by oral use|Patients will be given sulodexide 1200 LSU per day intravenously for 2 weeks,then receive 1000 LSU per day orally for 50 weeks.
16210016|NCT01316068|Drug|use of sulodexide orally only|Patients receive 1000 LSU per day orally for 52 weeks
16210017|NCT01316055|Drug|Dalfampridine-ER|2 days of single dose 7.5 mg, 4 days of bid dosing, and a 3 day follow-up
16210018|NCT01316042|Drug|sugar pill|2 pills per day for 12 months
16210019|NCT01316042|Drug|Metformin, glucophage|2 212.5mg pills/day for 12 months
16210020|NCT01316029|Procedure|Okada Purifying Therapy|Each participant received a single session of Okada Purifying Therapy lasting 30 minutes or longer, administered by a voluntary certified practitioner.
16210021|NCT01316016|Dietary Supplement|Rose hip|40 g of rose hip powder daily for 6 weeks.
16210022|NCT01316003|Other|Optical coherence tomography|Optical coherence tomography
16210023|NCT01315990|Drug|FOLFIRI + Cetuximab|"Cetuximab (Erbitux® )- Cetuximab is a recombinant IgG1 chimeric monoclonal antibody directed against human epidermal growth factor receptor (EGFR).
~FOLFIRI regimen
~Administration Schedule:
~Cetuximab at a initial dose 400 mg/sqm (first week), then 250 mg/sqm on day 1 and 8 Background Chemotherapy (every two weeks)
~Irinotecan 180 mg/m² iv , 90 min on day 1
~Folic acid (racemic) 400 mg/m², 120 min on day 1
~5-FU 400 mg/m² bolus on day 1
~5-FU 2400 mg/m² iv over 46 h on day 1 to 2"
16210024|NCT01315977|Dietary Supplement|Green tea|Each subject will take either green tea (2%w/v), or water, twice a day for twelve weeks, then wash out for twelve weeks and swap onto the other treatment (either green tea of water) for another twelve weeks in addition to their normal food and beverage intake
16210025|NCT01315964|Dietary Supplement|plant stanol ester|3 gr of plant stanol esters per day in a margarine product as part of daily diet for a period of 6 months
16210026|NCT01315951|Biological|Petroleum Jelly|Every patient will be instructed to wet the affected area, blot dry, and then apply petroleum jelly to the area before bedtime. This regimen is to be followed every other night until symptoms diminish. The patient should follow-up at one week, two weeks, and four weeks after treatment begins to see the outcome.
16210027|NCT01315938|Drug|Abatacept Active Treatment|Participants will be treated with abatacept by intravenous infusions a total of seven times at week(s) 0, 2, 4, 8, 12, 16 and 20 weeks.
16210028|NCT01315938|Drug|Abatacept Delayed-Onset Treatment|Participants will be treated with abatacept for 6 months and received a total of seven intravenous infusions at weeks 12, 14, 16, 20, 24, 28 and 32.
16210029|NCT01315912|Drug|Letrozole|2.5 mg /day for 5 days
16210030|NCT01315899|Drug|ORM-12471 30mg|Given as a single dose once during the crossover study as per Williams design
16210031|NCT01315899|Drug|ORM-12471|Given as a single dose once during the study as per Williams crossover design
16210032|NCT01315899|Drug|placebo|Given once as a single dose during the study as per Williams crossover design
16210033|NCT01315886|Drug|SL fentanyl|SL fentanyl will be administered during 7- 15 BTcP episodes during a maximum period of 21 days, following a baseline period with standard BTcP treatment. The start dose of SL fentanyl is selected individually according to a standardized conversion ratio. The maximum start dose is limited to 400 μg. For a single BTcP episode no more than two (2) tablets or a maximum dose of 800 μg should be given.
16210034|NCT01315873|Drug|Bendamustine|"On days 1 and 4 of each cycle, bendamustine is given at 90 mg/m^2 after bortezomib . Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.
~Patients will be treated until disease progression after at least one cycle of treatment."
16210035|NCT01315873|Drug|Bortezomib|"On days 1 and 4 of each cycle, bortezomib is given first at 1.3 mg/m^2 followed by bendamustine given at 90 mg/m^2. Patients will be dose reduced to 75 mg/m^2, and then to 60 mg/m^2 bendamustine on days 1 and 4 if ANC is not >1 x 10^9/L and platelets are not >50 x 10^9/L on day 1 of each cycle.
~Patients will be treated until disease progression after at least one cycle of treatment."
16210036|NCT01315860|Other|Postural Analysis|Measure the subject's weight, sway rate and shift of center of gravity on a postural scale for 15 seconds. Measure lumbosacral angle with an inclinometer.
16210037|NCT01315847|Drug|telcagepant|Single oral doses of telcagepant 1120 mg (Part I - Period 1) and 140 mg (Part I - Period 2; Part III - Period 1 and 2)
16210038|NCT01315847|Drug|[11C]MK-4232|Single intravenous doses of ~300 MBq [11C]MK-4232 administered as a 5 minute infusion (Part I - Baseline, Period 1 and 2; Part III - Period 1 Baseline and Period 1, and Period 2 Baseline and Period 2)
16210039|NCT01315821|Drug|Saccharomyces boulardii|5 million units/day for 3 months
16210040|NCT01315821|Drug|Placebo|Placebo for 3 months
16210042|NCT01315756|Device|Use of Few Touch Application (FTA)|"The users will receive a Smartphone with the diabetes diary application (the Few Touch application), a self-help tool that consists of five main elements accessible to the user. The five elements are the food habits registration, blood glucose data management system, physical activity registration, personal goals setting and general information. While blood glucose data is automatically transferred to the phone from the blood glucose meter when the user has performed a measurement, activity data and food habits have to be entered manually by the user."
16210043|NCT01315756|Device|Use of FTA and health counseling based on TTM and CBT|The users will additionally receive health counseling based on TTM and CBT by a diabetes nurse with individualized feedback via SMS from the diabetes nurse which is based on the patient's initiative (via SMS). In addition, the diabetes nurse will call the patients three times during this period and discuss progress. Both the SMS-messages and the calls will be based on CBT according to the TTM-level. The intervention allows information to be given both in an individualized and tailored manner for each particular patient by the nurse, but also in a general way via SMS. The patients need to understand the relationship between areas such as glucose levels, diet, exercises and medicine, in the context of their own lifestyle needs.
16210044|NCT01315743|Behavioral|Team COOL|1) a classroom-based experiential curriculum that incorporated school, family and community-linked activities to promote physical activity, healthy eating and limited television viewing, 2) environmental modifications of food and beverage offerings and physical activity opportunities at school and 3) a teacher-guided, youth-directed health advisory council to promote and support physical activity, healthy eating and limited television viewing.
16210045|NCT01315730|Device|Tactile Stimulation|See Arms
16210046|NCT01315704|Drug|Drug intervention|before-after interventional (anti-dementia drugs and/or vitamin D) study
16210047|NCT01315691|Drug|Liposomal amikacin for inhalation|"Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via nebulization.
~590 mg of liposomal amikacin for inhalation is administered once daily using the PARI Investigational eFlow® Nebulizer.
~Administration time is approximately 13 minutes.
~Liposomal amikacin for inhalation will be administered for 28 days followed by 56 days off treatment."
16210048|NCT01315691|Drug|Placebo for liposomal amikacin for inhalation|"Placebo is provided as a sterile aqueous lipid dispersion for inhalation via nebulization.
~Administration procedures, volume and administration time are the same as for Arikace™.
~Placebo will be administered for 28 days."
16210049|NCT01315678|Drug|Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer.|"Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via nebulization.
~590 mg of liposomal amikacin for inhalation is administered once daily using the PARI Investigational eFlow® Nebulizer.
~Administration time is approximately 13 minutes.
~liposomal amikacin for inhalation will be administered for 3 cycles where each cycle consists of 28 days on-treatment followed by 28 days off-treatment."
16210050|NCT01315678|Drug|Tobramycin inhalation solution using a PARI LC® Plus nebulizer.|"300 mg tobramycin inhalation solution is administered twice a day using a PARI LC® Plus nebulizer.
~Nebulization time is approximately 20 minutes for each administration.
~Tobramycin inhalation solution will be administered for 3 cycles where each cycle consists of 28 days on-treatment followed by 28 days off-treatment"
16210051|NCT01315665|Dietary Supplement|Broccoli sprouts|Subjects (both healthy volunteers and subjects with cystic fibrosis) will consume 100 gm of raw broccoli sprouts once daily for 5 consecutive days.
16210052|NCT01315652|Behavioral|Comorbidities treatment|" Comorbidities treatment:Number of actions initiated in order to treat or prevent Rheumatoid Arthritis comorbidities during the 6 months follow-up"
16210053|NCT01315652|Behavioral|Auto-DAS|"Auto-DASNumber of patients with a modification in their treatment between baseline and 6 months visits"
16210054|NCT01315639|Biological|biomarkers, MRI and CSF|MRI at Day 0 and month 24 (or conversion) Biomarkers at Day 0 et month 24 (or conversion) CSF at D0
16210055|NCT01315626|Other|Primary Care Educational event|The purpose of this study is to assess the accuracy of primary care physicians in diagnosing BE and evaluate the impact of an educational intervention targeting those primary care physicians and providing instruction in the recognition and treatment of BE. The hope is that a better understanding of the disease will result in more accurate diagnoses and ultimately in more appropriate care for these patients. In addition to better care for patients, earlier recognition of bronchiectasis may result in a decrease in health care costs.
16210056|NCT01315587|Device|repetitive Transcranial Magnetic Stimulation (Magstim rapid2 )|"3 pulses at 50Hz repeated each 200 ms for 2 seconds
~80% MT
~20 days treatment"
16210057|NCT01315587|Device|repetitive Transcranial Magnetic Stimulation (Magstim rapid2)|LDLPFC 110% MT 15 Hz 20 days
16210058|NCT01315587|Device|repetitive Transcranial Magnetic Stimulation(Magstim rapid2)|Placebo treatment: Sham coil
16210059|NCT01315574|Drug|Travoprost|One drop Travatan Z (0.004% ophthalmic solution) in affected eye once daily.
16210060|NCT01315574|Drug|Latanoprost|One drop Xalatan (0.005% ophthalmic solution) in affected eye once daily.
16210061|NCT01315561|Other|acupuncture, injection|MSAT and intramuscular injections of diclofenac(NSAID)
16210062|NCT01315522|Device|ComVi stent|Endoscopic insertion of ComVi stent
16210063|NCT01315522|Device|Uncovered SEMS|Endoscopic insertion of uncovered SEMS
16210064|NCT01315496|Drug|Immunoglobulin G|Immunoglobulin 1.5-2g/Kg/3days
16210065|NCT01315483|Other|Weight Loss Dietary Pattern|Diet-physical activity program creating a weekly negative energy balance equivalent to 3500 kcal. Intervention groups receive PA protocol promoting the Physical Activity Guidelines and translated in step recommendations, but one of two diets with divergent dietary patterns (opposing fat and CHO content) that do not overlap >+5% in CHO and fat content. Macronutrient values reflect a 'pattern' or ratio within (LC 3:2 ratio for F:CHO; HC 1:4 ratio for F:CHO ) and between diets (LC:HC 3:1 for fat; LC:HC 1:2 for CHO). Six-week meal plans for five calorie levels available and incorporate educational material, supporting program components (e.g. self monitoring tools) and core competencies reinforcing weight loss behaviors in order to promote high levels of dietary adherence.
16210066|NCT01315470|Drug|neupogen administration for women with recurrent IVF failure|neupogen 300 mcg - twice
16210067|NCT01315444|Drug|Stop PPI gradually|
16210068|NCT01315444|Drug|Stop PPI gradually|
16210141|NCT01314885|Drug|PH-797804|30mg, Oral, single dose
16210142|NCT01314885|Drug|Placebo for PF-03715455|Single dose, inhaled, Placebo for PF-03715455
16210069|NCT01315431|Drug|Tesetaxel plus capecitabine|"Study medication, which will include tesetaxel capsules and capecitabine tablets, will be administered orally for two 21-day cycles. In each cycle, tesetaxel will be administered at a dose of 27 mg/m2 on Day 1, and capecitabine will be administered in Cohort 1 at a dose of 2000 mg/m2/day and in Cohort 2 at a dose of 1750 mg/m2/day (in 2 equally divided doses) on Day 1 through Day 14.
~At the conclusion of Cycle 2, patients who, in the opinion of the investigator, appear to have benefitted from protocol therapy may receive up to 6 additional cycles under a separate protocol."
16210070|NCT01315418|Other|1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)|
16210071|NCT01315418|Other|2-Non fermented dairy product (control)|
16210072|NCT01315405|Behavioral|Emotional facial expression recognition tests|"20 patients with an Idiopathic Parkinson's disease
~+ 20 paired healthy volunteers (on sex, age, and education)
~After inclusion, patients are evaluated two times: they are studied without medication (MED OFF) and with medication (STIM ON) in a randomized order. The 2 evaluations should be spaced out 15 days to one month (J0 and J+15d)
~Healthy subjects have only one visit J0 (inclusion and emotional facial expression recognition tests are made at the same time)"
16210073|NCT01315392|Procedure|delayed closure|wounds packed open with normal saline wet to dry gauze dressings and were returned to the operating room 36 to 72 hours after initial procedure for a second debridement and definitive closure.
16210074|NCT01315392|Procedure|immediate wound closure|traumatic and surgical wounds closed at the initial surgical intervention
16210075|NCT01315379|Behavioral|Prolonged Exposure Therapy|This intervention comprises 12-18 sessions of cognitive behavior therapy for PTSD with the components (a) Psychological education, (b) in vivo exposure (c) prolonged imaginal exposure, (d) cognitive restructuring (e) summary and relapse prevention.
16210076|NCT01315366|Dietary Supplement|Euro D and Ci-CalD|Ci-Cal D (1000mg/day) and vitamin D (500IU/day) daily, plus a supplement of vitamin D3 (20,000 IU/wk) for one year.
16210077|NCT01315366|Dietary Supplement|Euro D, Ci-CalD|Ci-Cal D(1000mg/day) and vitamin D (500IU/day) Ci-CalD daily, plus a weekly placebo Euro D supplement for one year.
16210078|NCT01315353|Procedure|Cervical Cryotherapy|Participants had cervical cryotherapy within 7 days after study entry. The cryotherapy consists of two 3-minute freezes separated by 5 minutes of thawing.
16210079|NCT01315353|Procedure|Loop Electrosurgical Excision Procedure (LEEP)|Loop Electrosurgical Excision Procedure (LEEP): Participants found to have CIN2+ by biopsy had LEEP, an electro-surgical procedure used to treat high-grade cervical dysplasia.
16210080|NCT01315340|Procedure|Ocular rigidity, outflow facility and intraocular pressure measurement|The measurement procedure includes cannulation of the anterior chamber of the eye, under sterile conditions. Infusion of the eye with microvolumes of a saline solution is performed, followed by manometric measurement of intraocular pressure, in order to quantify ocular rigidity. Outflow facility is estimated from recordings of intraocular pressure after the infusion is stopped.
16210081|NCT01315327|Drug|Omega-3 Fatty Acids|Omega-3 fatty acids (derived from fish oil)
16210082|NCT01315327|Drug|Olive oil|Placebo
16210083|NCT01315314|Drug|Balance, Fresenius Medical Care, Germany|low glucose degradation product (GDP)-containing peritoneal dialysis fluid (PDF)
16210084|NCT01315301|Other|Comparison of different treatment strategies|600 mg efavirenz based HAART initiated one week after starting rifampicin based short course anti tuberculosis treatment.
16210085|NCT01315301|Other|Comparison of different treatment strategies|600 mg efavirenz based HAART initiated four weeks after starting rifampicin based short course anti tuberculosis treatment
16210086|NCT01315301|Other|Comparison of different treatment strategies|600 mg efavirenz based HAART initiated eight weeks after starting rifampicin based short course anti tuberculosis treatment.
16210087|NCT01315288|Other|One of 6 video presentation by one of 4 presenters|
16210088|NCT01315275|Drug|Ranibizumab|
16210089|NCT01315262|Drug|Sildenafil|1:1 Viagra 100 mg daily (taken either at bedtime - if sexual intercourse is not expected - or 1 hour prior to sexual intercourse, no more than one 100 mg dose of sildenafil per day) vs. Viagra 100mg OD (i.e. one hour prior to sexual intercourse)
16210090|NCT01315249|Drug|indacaterol and glycopyrronium (QVA149)|QVA149 capsules delivered via dry powder inhaler (SDDPI), once daily.
16210091|NCT01315249|Drug|Placebo to fluticasone/salmeterol|Placebo to fluticasone/salmeterol delivered via Accuhaler® device, twice daily.
16210092|NCT01315249|Drug|fluticasone/salmeterol|Fluticasone/salmeterol dry inhalation powder delivered via Accuhaler® device, twice daily.
16210093|NCT01315249|Drug|Placebo to indacaterol and glycopyrronium (QVA149)|Placebo to QVA149 delivered via dry powder inhaler (SDDPI), once daily
16210094|NCT01315236|Drug|Liposomal amikacin for inhalation (LAI)|"Liposomal amikacin for inhalation is provided as a sterile aqueous liposomal dispersion for inhalation via nebulization.
~590 mg of liposomal amikacin for inhalation is administered once daily using the PARI Investigational eFlow® Nebulizer.
~Administration time is approximately 13 minutes.
~Liposomal amikacin for inhalation will be administered for 84 days in the double-blind, randomized portion of the study.
~Subjects can continue with 84 additional days of dosing in the open label extension."
16210095|NCT01315236|Drug|placebo|"Placebo is provided as a sterile aqueous lipid dispersion for inhalation via nebulization.
~Administration procedures, volume and administration time are similar to LAI.
~Placebo will be administered for 84 days only during the double-blind, randomized portion of the study."
16210096|NCT01315223|Other|Lung impedence-guided treatment|One hundred fifty patients with CHF will be treated according to common practice and values of lung impedance
16210097|NCT01315210|Drug|D-Ribose Powder|5 g TID for 12 Weeks
16210098|NCT01315210|Dietary Supplement|Placebo Powder|5 g TID for 12 Weeks
16210099|NCT01315197|Other|Massage|Massage Anmá: 7-8 sessions, twice per week, kneading and pressure points on the bladder meridian
16210100|NCT01315184|Behavioral|Recovery Line Support System|"Full time access (24 hours/7 days per week) to an automated, telephone-based, interactive, voice response (IVR)system for 4 weeks.
~The program was developed based on a behavioral theory of substance abuse, and comprises four components: 1) self-assessment 2) learning about skills , 3) activities for current help and skills training, and 4) Feedback."
16210101|NCT01315171|Dietary Supplement|Medium chain triglycerides|4 tablespoons/day for 2 weeks
16210102|NCT01315158|Drug|Propofol Alone|"Recommended Propofol doses before considering crossover:
~Induction: 2-2.5 mg/kg
~Maintenance: 0.1-0.2 mg/kg/min"
16210103|NCT01315158|Drug|Propofol+Benzo/Opioids|"Recommended Versed:
~a. Prior to intubation
~patient is < 50 kg = 1 mg Versed
~patient is 50-75 kg = 1.5 mg Versed
~patient is > 75 kg = 2 mg Versed
~Recommended Fentanyl
~Prior to intubation = 0.5 ug/kg
~Total procedural dose = 1 ug/kg"
16210104|NCT01315145|Procedure|Percutaneous Lumbar Decompression|The percutaneous procedure is performed under fluoroscopic guidance to effect a lumbar decompression with minimal surrounding tissue and bone disruption. The mild® Device Kit is utilized to access, capture and remove bone and tissue.
16210105|NCT01315145|Drug|Epidural Steroid Injection|Injection of epidural steroids into the lumbar spine
16210106|NCT01315132|Device|Matched Sibling Allogeneic Transplantation|Patients undergoing myeloablative hematopoietic stem cell transplant from HLA identical related donors using cyclophosphamide tolerization
16210107|NCT01315119|Procedure|SPY Intra-Operative Angiography|Calculated per patient
16210108|NCT01315106|Device|Magnetic Resonance Image Scanner|Magnetic Resonance Imaging; 1.5 Tesla or 3 Tesla MRI scanner
16210109|NCT01315093|Drug|Heparin, Low-Molecular-Weight|Heparin from start till hcg test
16210110|NCT01315093|Drug|no heparin|
16210111|NCT01315054|Behavioral|MMT provider dosage training|Training on methadone dosing provided to health care providers working in methadone maintenance clinics
16210112|NCT01315054|Behavioral|targeted counseling|targeted counseling provided to methadone maintenance clinic attendees
16210113|NCT01315054|Other|national guidelines|Provided a hard copy of the existing national guidelines for methadone dosing
16210114|NCT01315041|Drug|Capsicum frutescens fruits, homeopathic medicine|5 drops, PO, 3 times a day, during 16 weeks
16210115|NCT01315041|Drug|Inert alcoholic solution|5 drops, PO, 3 times a day, during 16 weeks
16210116|NCT01315028|Other|Cognitive Interpersonal Therapy|Cognitive Interpersonal Therapy in Early Bipolar Disorder: Individuals will receive up to six months of individual CIT-BP. CBT will emphasise assessment, engagement and formulation; normalizing and compassionate understanding; specific cognitive and behavioural strategies; self-management and social rhythm regulation; affect regulation, and staying well (Gumley & Schwannauer, 2006).
16210117|NCT01315028|Other|Treatment As Usual|The comparison group is treatment as usual (TAU). This will comprise of the individuals normal psychiatric care and will vary with individual and locality and is therefore not specified.
16210118|NCT01315015|Other|Contrast enhanced breast MRI|Gadolinium contrast is administered as a bolus with a standard dose of 0.1 mL/kg followed by a saline flush of 30 mL.
16210119|NCT01315002|Drug|Transdermal nicotine patch|7mg transdermal nicotine patch (non-smoking subjects) 14mg transdermal nicotine patch (smoking subjects)
16210120|NCT01315002|Drug|Placebo patch|Placebo patch
16210121|NCT01314989|Drug|Cyproheptadine|0,25mg/kg/day orally in 2 doses per day (2mg/5 ml)for 1 month
16210122|NCT01314989|Drug|Sugar pill|liquid placebo
16210123|NCT01314976|Drug|Metronidazole|"Metronidazole, oral suspension, 40mg/ml.
~1 treatment period of 40mg/kg/day for 10 days, 3 daily dosages. Administered by parents."
16210124|NCT01314976|Drug|Placebo|"Placebo.
~1 treatment period of 1ml/kg/day for 10 days, 3 daily dosages. Administered by parents.
~Placebo formulation is identical to Flagyl® (Metronidazole), oral suspension from Sanofi-Aventis."
16210125|NCT01314963|Device|Prototype intraoperative handheld gamma camera (pIHGC)|The prototype intraoperative handheld gamma camera (pIHGC) consists of a parallel-hole lead collimator coupled to a pixilated sodium iodide-thallium [NaI(Tl)] scintillation crystal array, itself coupled to a flat panel, multi-anode Hamamatsu H8500 position-sensitive photomultiplier tube. The collimator is 5x5 cm2 large in area and 1.5 cm thick, with 1.3 mm hexagonal holes and 0.2 mm septa. The 1.7 mm pitch crystal array is composed of 29x29 individual crystals, each 1.5x1.5x6 mm3 in size.
16210126|NCT01314963|Device|Lymphoscintigraphy with intraoperative gamma probes (GP)|Lymphoscintigraphy with standard of care intraoperative gamma probes (GP)
16210127|NCT01314963|Radiation|radioactive Tc99M|Lymphoscintigraphy involves injection of 0.4 to 1.0 mCi of radioactive Tc99M sulfur colloid around at the tumor site.
16210128|NCT01314950|Behavioral|Home based occupational therapy|"An occupational therapist (OT) will deliver the home-based intervention. There are three cycles of intervention over two years, with each cycle delivering eight 60-90 minute home sessions. Cycle one takes place over 16 weeks, cycle two over 32 weeks, and cycle three over one year. Telephone calls take place in intervening weeks, with additional phone calls allowed to assist with problem solving and interval problems. At minimum, the OT will perform an assessment at the beginning of each cycle in order to tailor the home based component for individual dyads at each cycle. The OT will collaborate with the patients and caregivers to develop client centered goals with homework each week in order to encourage carryover of strategies, home environmental modifications, or home exercise programs."
16210129|NCT01314950|Behavioral|Best practices primary care|Collaborative care is provided by an advanced practice nurse working in collaborations with a family caregiver, the primary care physician, and geriatric medicine specialists. Caregivers complete a formal assessment of problematic behaviors to assess current symptoms and stressors, and the care manager makes recommendations based on these results and using standardized protocols. Protocols focus first on non-pharmacologic interventions. If these interventions fail, the care manager collaborates with the primary care physician and/or specialists to institute protocol-based drug therapy or other strategies. Patients and caregivers are also offered access to support groups.
16210130|NCT01314937|Drug|Mebendazole|Single-dose 500 mg mebendazole tablet
16210131|NCT01314937|Other|Usual care|Routine child health interventions (e.g. age-specific immunizations, supplementations, etc.)
16210132|NCT01314924|Dietary Supplement|Dark chocolate|70% cocoa
16210133|NCT01314911|Drug|Oseltamivir|Subjects were prescribed Oseltamivir twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
16210134|NCT01314911|Drug|Placebo|Subjects were prescribed the matching placebo twice daily for 5 days, and each dose consisted of one capsule of placebo.
16210135|NCT01314898|Drug|3 mg PF-03882845|3 mg PF-03882845, single oral dose
16210136|NCT01314898|Drug|10 mg PF-03882845|10 mg PF-03882845, single oral dose
16210137|NCT01314898|Drug|30 mg PF-03882845|30 mg PF-03882845, single oral dose
16210138|NCT01314898|Drug|100 mg PF-03882845|100 mg PF-03882845, single oral dose
16210139|NCT01314898|Drug|Spironolactone|100 mg spironolactone, single oral dose
16210140|NCT01314885|Drug|PF-03715455|20mg, Inhaled, single dose
16210144|NCT01314872|Drug|Vibegron|Participants received vibegron oral tablets at dosages of 3 mg, 15 mg, 50 mg, or 100 mg depending on their vibegron arm assignment, taken orally each morning.
16210145|NCT01314872|Drug|Tolterodine ER|Participants received one tolterodine ER 4 mg capsule, taken orally once a day.
16210146|NCT01314872|Drug|Placebo matching vibegron|Participants received placebo matching vibegron tablets, taken orally each morning.
16210147|NCT01314872|Drug|Placebo matching tolterodine ER|Participants received placebo matching tolterodine ER capsule, taken orally each morning.
16210148|NCT01314859|Drug|Nifedipine|"Oral Treatment with Nifedipine capsules (10mg)
~Initial dose: 20 mg of nifedipine (2 capsules of 10 mg).
~Maintenance Dose: 20 mg of nifedipine (2 capsules of 10 mg) every 6 hours.
~Maximum Duration of the treatment: 48 hours."
16210149|NCT01314859|Drug|Atosiban|"Intravenously Treatment with Atosiban (7.5mg/ml)
~Initial Dose: IV bolus injection during 1 minute + Intravenous infusion 7.5 mg/ml during 3 hours.
~Maintenance: Maintenance intravenous infusion 7.5 mg/ml at least 18 hours to a maximum of 45 hours.
~Maximum Duration of the treatment: 48 hours."
16210150|NCT01314833|Drug|Docetaxel Cyclophosphamide|"Docetaxel 75 mg/m² D1 Cyclophosphamide 600 mg/m² D1
~1 cycle = 21 days
~TC*6"
16210151|NCT01314833|Drug|Cyclophosphamide Fluorouracil Epirubicin Docetaxel|"1st -3rd Cycle: Fluorouracil 500 mg/m² D1 Epirubicin 100 mg/m² D1 Cyclophosphamide 500 mg/m² D1
~1 cycle = 21 days
~4th-6th Cycle: Docetaxel 100mg/m² D1
~1 cycle = 21 days CEF*3-T*3"
16210152|NCT01314833|Drug|Epirubicin Cyclophosphamide Paclitaxel|"1st-4th Cycle: Epirubicin 90 mg/m² D1 Cyclophosphamide 600 mg/m² D1
~1 cycle = 21 days
~5th-8th Cycle: Paclitaxel 80mg/m² D1, 8, 15
~1 cycle = 21 days EC*4-P*4"
16210153|NCT01314820|Other|normal saline injection|20 cc normal saline injection into knee joint
16210154|NCT01314820|Other|sham injection|no saline injection
16210155|NCT01314781|Drug|solifenacin|solifenacin 5mg tablet once daily
16210156|NCT01314781|Procedure|PFMT and WBVT|pelvic floor muscle and whole body vibration training once a week
16210157|NCT01314768|Behavioral|Brief intervention|Structured behavioural Brief intervention given by trained GPs
16210158|NCT01314768|Other|Business as usual|GPs to treat patient as they have until now based on best established practice
16210159|NCT01314768|Other|Screening and outcome evaluation only|No additional intervention
16210160|NCT01314768|Other|Screening and outcome evaluation only|No additional intervention
16210161|NCT01314755|Dietary Supplement|IMPACT|IMPACT (Nestlé Healthcare Nutrition, Minnetonka, MN, USA) an 'immune-enhancing' feed which contains supplemental L-arginine (1.25 78 g/L), dietary nucleotides (1.2 g/L) and omega-3 fatty acids in the form of 79 eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) (EPA/DHA 1.7 g/L) 80 as its active ingredients.
16210162|NCT01314755|Dietary Supplement|An iso-caloric, iso-nitrogenous control feed|
16210163|NCT01314742|Drug|Biotene OralBalance® gel|Biotene OralBalance® gel is dispensed as 42gm, patient specific tube from hospital's Central Pharmacy. One pea-size oral application every 4 hours, or at touch time, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization.
16210164|NCT01314742|Other|Sterile Water moisten cotton tipped applicator|One oral care application will be performed every 4 hours, or at touch times, to gums and tongue, as long as the subject remains mechanically ventilated for the duration of hospitalization.
16210165|NCT01314729|Device|Fiber-reinforced-composite retainer|this type of retainer is placed on the lingual surface of teeth from canine to canine just before the completion of orthodontic treatment
16210166|NCT01314729|Device|Composite-wire retainer|this type of retainer is placed on the lingual surface of teeth from canine to canine just before the completion of orthodontic treatment to prevent treatment relapse
16210167|NCT01314716|Drug|AZLI|AZLI 75 mg reconstituted with diluent and administered via nebulizer three times daily
16210168|NCT01314716|Drug|Placebo|Placebo to match AZLI administered via nebulizer three times daily
16210169|NCT01314703|Drug|ChloraPrep One-Step|10.5 ml applicator preoperative skin preparation
16210170|NCT01314703|Drug|70% isopropyl alcohol|10.5 ml applicator
16210171|NCT01314690|Other|Caloric transition|6 week low calorie diet followed by 6 week stabilization period
16210172|NCT01314677|Procedure|positron emission tomography/computed tomography (PET/CT)|Undergo FDG PET/CT
16210173|NCT01314677|Radiation|fludeoxyglucose F 18|Undergo FDG PET/CT
16210174|NCT01314651|Behavioral|Stimulus Control and Sleep Restriction|5 instructions in stimulus control and individually-tailored sleep restriction
16210175|NCT01314651|Behavioral|Lifestyle Modification|5 instructions in changing general lifestyle habits (maintaining consistent liquid intake, range of motion exercises, eating a serving of protein in the morning, etc.)
16210176|NCT01314638|Other|Workshop balances|one workshop per week for 20 weeks. Evaluation before and after.
16210177|NCT01314612|Behavioral|Cognitive-Behavioral Insomnia and Nightmare Group|Group based cognitive-behavioral therapy meeting weekly for 90 minutes over the course of 9 weeks. Utilizes stimulus control, sleep scheduling, and progressive muscle relaxation to address symptoms of insomnia. Imagery rehearsal and rescripting are used to address nightmare symptoms.
16210178|NCT01314599|Drug|PM01183 1 mg Powder for concentrate for solution for infusion and PM01183 4 mg Powder for concentrate for solution for infusion|"PM01183 Drug Product will be provided as a lyophilized powder for concentrate for solution for infusion with a strength of 1.0 mg/vial and 4.0 mg/vial.
~Before use, the vials will be reconstituted with 2 ml or 8 ml of sterile water for injection to give a solution containing 0.5 mg/ml of PM01183."
16210179|NCT01314586|Dietary Supplement|secoisolariciresinol diglucoside-containing extract of flaxseed|0, 150 or 300 mg/day as 2 pills taken at breakfast and dinner, dietary counseling to comply with NCEP Step I diet
16210180|NCT01314573|Behavioral|Sprint interval exercise|3 session per week of exercise on a exercise cycle ergometer. Each session involves 30s of maximal exercise followed by 4.5 min of easy cycling at 10W. This is repeated 4 times at each exercise session.
16210181|NCT01314573|Behavioral|Maximal continuous exercise|3 sessions per week of an exercise intervention involving maximal cycling until the participant has completed an amount of work equivalent to a sprint interval training session. This exercise lasts between 3 and 3.5 minutes.
16210182|NCT01314560|Other|Blood sample|Blood sample
16210267|NCT01313806|Device|Placebo|Inactive Resonator Device
16213370|NCT01289808|Drug|Glucose 25%|1ml glucose once per os
16210183|NCT01314508|Drug|Increlex|Increlex therapy will begin at 40 micrograms/kg/day twice a day. The dose will be escalated by 20 mcg twice a day every other week up to 100mcg/kg/week.
16210184|NCT01314495|Drug|Abatacept|Abatacept will be administrated as a 30 minute intravenous infusion.
16210185|NCT01314495|Drug|Inactive infusion|Placebo will be administered as a 30 minute intravenous infusion.
16210186|NCT01314482|Drug|Minocycline|200mg bd for 3 days before surgery
16210187|NCT01314456|Device|NaviGo|Video recording of a normal TRUS guided prostate biopsy with additional 2 , non invasive,electromagnetic sensors attached to the TRUS probe and the patient's back,- to allow for a 3D modeling of the prostate.
16210188|NCT01314443|Other|Nicotine Replacement Therapy (NRT)|Participants will quit smoking with nicotine patches
16210189|NCT01314443|Dietary Supplement|Gamma-Tocopherol|Participants will take gamma-tocopherol (500 mg/d) supplements for 7 days
16210190|NCT01314443|Other|Placebo|Participants will take placebo for 7 days
16210191|NCT01314443|Behavioral|Smoking cessation|Participants will quit smoking without any pharmacological aids
16210192|NCT01314417|Drug|Methotrexate|400 μg/100 μL monthly injections for the first 3 months, then as needed per the treatment criteria
16210193|NCT01314391|Genetic|mutation analysis|
16210194|NCT01314391|Genetic|polymerase chain reaction|
16210195|NCT01314391|Other|laboratory biomarker analysis|
16210196|NCT01314378|Behavioral|Mindfulness Training|Eight session intensive behavioral training program for smokers
16210197|NCT01314378|Behavioral|Cognitive-Behavioral Therapy|Eight session intensive behavioral intervention for smokers
16210198|NCT01314352|Drug|Desloratadine|Desloratadine Tablets, 5 mg
16210199|NCT01314339|Drug|Desloratadine|Desloratadine Tablets, 5 mg
16210200|NCT01314313|Device|TAVR Implantation with SAPIEN XT|Operable Group with SAPIEN XT
16210201|NCT01314313|Device|SAVR Implantation|Control Group
16210202|NCT01314300|Drug|Lidocaine|Lidocaine 5% plaster
16210203|NCT01314274|Drug|Bevacizumab|100mg intranasal submucosal bevacizumab in 10ml
16210204|NCT01314274|Drug|NaCl|10ml of 0.9% NaCl intranasal submucosal
16210205|NCT01314261|Drug|ABT-267|5 mg or 25 mg tablets
16210206|NCT01314261|Drug|Pegylated interferon (pegIFN)|Syringe, 180 µg/0.5 mL for subcutaneous injections administered weekly
16210207|NCT01314261|Drug|Ribavirin (RBV)|200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day
16210208|NCT01314261|Other|Placebo for ABT-267|Participants received matching placebo tablet at each dose level for ABT-267.
16210209|NCT01314248|Device|each child will receive both the LMA and ILA|each child will receive both the size 2 LMA and size 1.5 ILA
16210210|NCT01314222|Drug|BMS-954561|
16210211|NCT01314222|Drug|Pregabalin|
16210212|NCT01314222|Drug|Placebo matching BMS-954561|
16210213|NCT01314222|Drug|Placebo matching Pregabalin|
16210214|NCT01314209|Drug|Dexmedetomidine|Dexmedetomidine 0.7 microg/kg/h 12-hour intravenous infusion
16210215|NCT01314196|Other|therapeutic exercises|therapeutic exercises for the shoulder and scapula stabilizers using bat without charge, training and isometric exercises commuting to the cuff muscles, without producing subacromial impaction.
16210216|NCT01314196|Other|biceps resistance training and therapeutic exercises|The biceps resistance training based on calculations of maximum resistance (MR), being conduct in three series 10 reps with 50% of MR in the first series of training and 75% of MR in the second series, with 2 minutes between each and therapeutic exercises for the shoulder and scapula stabilizers.
16210217|NCT01314183|Other|Exercise|The program starts with a 10 minute aerobic exercise warm-up (treadmill walking or stationary cycling). Subjects then perform a series of strengthening, stretching, and neuromuscular control activities which are core exercises for the program and mandatory. In addition to the above core exercises, therapists have the option to select additional optional exercise activities, based on the initial examination findings. These exercises will address strength or flexibility in the hip, and ankle if impairments are identified in the initial examination.
16210218|NCT01314183|Other|manual therapy|The manual therapy (MT)techniques are maneuvers that are applied with manual force from the treating therapist. The MT techniques will include a series of accessory motion techniques, manual stretching , and soft tissue manipulation (deep massage to muscles and connective tissues associated with knee function). Core techniques include anterior-posterior and posterior-anterior tibiofemoral translations, superior-inferior and medial-lateral patellofemoral mobilizations, knee flexion and extension mobilizations that may be combined with varus-valgus stresses,medial-lateral tibial rotations, manual stretching of the quadriceps, rectus femoris, hamstring, and gastrocnemius muscles, and soft tissue manipulations of the quadriceps, peri-patellar tissues, hamstring, hip adductors, and gastroc-soleus muscle groups. There are optional MT techniques for the hip, and foot and ankle joints that can be selected by the therapist based on initial examination findings.
16210219|NCT01314170|Device|Susanna Implant|device
16210220|NCT01314157|Other|Isostretching|12 interventions (two times per week) for 45 minutes
16210221|NCT01314144|Drug|Bupivacaine|intraoperative wound soakage with 20ml of 0.5% bupivacaine with epinephrine and continuous infusion of 4ml/hr of 0.2% bupivacaine for 48 hours postoperatively
16210222|NCT01314131|Behavioral|Stimulation group|"Patients living in nursing home can be enrolled in the study by giving their verbal consent. The trial lasts two weeks for each patients and it will be performed in three parts :
~a cognitive and behaviour assessment : MMSE, BREF, NPI, IA
~an interest questionnaire for patients. It contains 40 questions about activities.
~the intervention : patients will be propose 5 activities. 4 of them are activities that patients are interested in. Each activity have to last 15 minutes and the stimulation is measured by a scale named Observational Measurement of Engagement ."
16210223|NCT01314118|Drug|abiraterone acetate in combination with prednisone|Abiraterone acetate will be taken as 4 x 250 mg tablets by mouth (PO) once daily. Prednisone will be taken as 2 x 2.5 mg tablets PO once daily.
16210224|NCT01314105|Drug|BIBF 1120 + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min|BIBF1120 twice daily along with standard therapy of PLD + carboplatin
16210225|NCT01314105|Drug|BIBF 1120+ PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min|BIBF1120 twice daily along with standard therapy of PLD + carboplatin
16210226|NCT01314105|Drug|BIBF 1120 + PLD 30 mg/m2 + CBDCA AUC5 mg/mL*min|BIBF1120 twice daily along with standard therapy of PLD + carboplatin
16210227|NCT01314092|Biological|Autologous cultured adipose derived stem cells(low dose group)|low dose group: 1x10e7 cells/mL At 6 weeks after first stem cell injection, fistula closing was assessed. If it is not completely closed, second injection would be applied in 2 weeks. Additional dosage would be doubled to first dosage.
16210228|NCT01314092|Biological|Autologous cultured adipose derived stem cells(high dose group)|high dose group: 2x10e7 cells/mL At 6 weeks after first stem cell injection, fistula closing was assessed. If it is not completely closed, second injection would be applied in 2 weeks. Additional dosage would be doubled to first dosage.
16210229|NCT01314066|Drug|Bevacizumab|Patients receiving drug will receive it as a single dose. Treatment will be given as 90-minute IV infusion. The patient will either receive Bevacizumab at 5 mg/kg OR Bevacizumab at 10 mg/kg.
16210230|NCT01314066|Drug|Placebo|Patients assigned to placebo-control group will receive a single dose of saline solution as a 90 minute IV infusion
16210231|NCT01314040|Other|Run in diet|Fully controlled dietary period during 9 days. Participants will receive approximately 15 en% of protein. The amount of protein intake from dairy, meat, and grain will be equal to each other
16210232|NCT01314040|Other|High meat protein diet|Fully controlled diet during 7 days. Participants will consume 18 en% protein, mainly from meat.
16210233|NCT01314040|Other|High dairy protein diet|Fully controlled dietary intervention during 7 days. Participants will consume 20 en% protein. Mainly from dairy
16210234|NCT01314040|Other|High grain protein diet|Fully controlled dietary intervention for 7 days. Participants will consume 20 en% of protein. Mainly from grain
16210235|NCT01314027|Drug|Neoadjuvant Chemotherapy with gemcitabine/oxaliplatin|"Patients with resectable cytologically proven adenocarinoma of the pancreatic head are randomized to arm A or B.
~Patients randomized to arm A receive an 8-week neoadjuvant chemotherapy with gemcitabine/oxaliplatin. Thereafter, surgery is performed if the restaging does not reveal a contraindication. Finally, all patients receive adjuvant gemcitabine for six months."
16210236|NCT01314027|Drug|adjuvant chemotherapy with gemcitabine|Patients randomized to arm B undergo surgery and receive the same adjuvant treatment as in arm A.
16210237|NCT01314014|Drug|Imexon|Amplimexon will be administered daily on Days 1-5 of 21-day treatment cycles as an intravenous infusion over a time course of 60 minutes. Subjects will receive 17 cycles of therapy for a total of one year on treatment. The Amplimexon starting dose for each subject in this study is 1000 mg/m² on each treatment day. Dose may be reduced by 25% for toxicity; after 2 dose reductions, subjects must be withdrawn from treatment.
16210238|NCT01314001|Drug|Varenicline|Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
16210239|NCT01314001|Drug|Placebo|"Day 1-3: 0.5mg once daily orally Day 4-7: 0.5mg twice daily orally Day 8-84: 1.0mg twice daily orally
~Week 1 - 6: 21mg placebo patch Week 7 - 8: 14mg placebo patch Week 9 - 11: 7mg placebo patch"
16210240|NCT01314001|Drug|Transdermal Nicotine|Week 1-6: 21mg nicotine patch Week 7-8: 14mg nicotine patch Week 9-11: 7mg nicotine patch
16210241|NCT01313988|Dietary Supplement|Plant sterols and fish oil|4 weeks intervention, 3 times daily
16210242|NCT01313988|Dietary Supplement|Plant sterols|4 weeks intervention, 3 times daily
16210243|NCT01313988|Dietary Supplement|Placebo|4 weeks, 3 times daily
16210244|NCT01313962|Drug|Flufirvitide-3 0.05 mg single dose|Nasal Spray
16210245|NCT01313962|Drug|Flufirvitide-3, 0.1 mg single dose|Nasal spray
16210246|NCT01313962|Drug|Flufirvitide-3, 0.2 mg single dose|nasal spray
16210247|NCT01313962|Drug|Flufirvitide-3, 0.4 mg single dose|Nasal spray
16210248|NCT01313962|Other|Placebo|Nasal spray
16210249|NCT01313949|Other|Training program|These diabetes patients will undergo a 32-hour 'Train the trainer' program (4 workshops, 8-hours each) led by health care experts in nutrition, physical activity, psychology and neuro-linguistic program [NLP] trainer to ensure the adequacy of knowledge and skills of these mentors.
16210250|NCT01313936|Drug|Metaiodobenzylguanidine (MIBG)|Chemotherapy will be given over 5 days for each course, with a single dose of 131I-MIBG on the second day of irinotecan. A total course will be defined as 42 days, or longer if hematopoietic recovery to eligibility criteria occurs after day 42.
16210251|NCT01313923|Drug|Sirolimus (formerly known as Rapamycin)|For low to moderate immunologic risk, the loading dose is 6mg immediately after transplantation, followed by 2mg PO Qday in conjunction with cyclosporine and corticosteroids. After 2-4 months, cyclosporine should be discontinued over 4-8 weeks while titrating sirolimus drug concentrations within the target-range with whole blood trough concentrations every 1-2 weeks. Monitoring is needed because cyclosporine inhibits the metabolism of sirolimus, and discontinuation of cyclosporine can lead to lower levels of sirolimus. In high immunologic risk patients, the loading dose is 15mg after transplantation, followed by 5mg PO Qday in conjunction with cyclosporine and corticosteroids for 12 months. A whole blood trough level is recommended between days 5 and 7 with adjustment to the daily dose.
16210252|NCT01313910|Dietary Supplement|Immunolin®|Immunolin® 500 mg capsules to be taken 5 capsules twice daily for eight weeks
16210253|NCT01313897|Drug|Bortezomib|bortezomib to be given days -9, -6, and -2 at 1.0mg/m2, i.v.
16210254|NCT01313884|Drug|Irinotecan|50 mg/m2/day x 5 days
16210255|NCT01313884|Drug|Vincristine|2 mg/m2 to a maximum of 2 mg
16210256|NCT01313884|Drug|Temozolomide|100 mg/m2/day x 5 days followed by 2 weeks treatment-free
16210257|NCT01313884|Drug|Doxorubicin|Starting dose 75 mg/m2 to a maximum of 450mg/m2
16210258|NCT01313884|Drug|Cytoxan|1200 mg/m2
16210259|NCT01313884|Drug|Pegfilgrastim|6 mg subcutaneous within 24 to 48 hours after each Regimen A cycle
16210260|NCT01313858|Drug|Simponi®|
16210261|NCT01313858|Drug|Methotrexate|Given concomitantly with Simponi®
16210262|NCT01313845|Drug|amantadine sulfate|infusion of amantadine sulfate 100mg/500ml/bottle over 3 hours twice a day
16210263|NCT01313845|Drug|0.9% sodium chloride|infusion of normal saline 500ml/bottle over 3 hours twice a day
16210264|NCT01313832|Other|remote ischemic preconditioning (RIPC)|RIPC will be performed by 5-min cycles of lower limb ischemia reperfusion using blood pressure cuff
16210265|NCT01313819|Drug|PK-Merz® 200mg/500ml inj(Amantadine) , Normal saline 500ml inj|IV amantadine at 200 mg in 500 cm3 of saline solution or normal saline 500 cm3 given over a 3-h period, twice a day for 2 days along with the pre-existing dopaminergic and non-dopaminergic medication
16210266|NCT01313806|Device|Resonator|Treatment group vs. Placebo group
16210268|NCT01313793|Drug|Treatment A-B|Subjects to receive 3 X 15 mg tablets of the clinical formulation in first period then 1 x 45 mg tablet of the commericializable formulation in 2nd period.
16210269|NCT01313793|Drug|Treatment B-A|Subjects to receive 1 x 45 mg tablet of the commericializable formulation in first period then 3X 15 mg tablets of the clinical formulation in 2nd period.
16210270|NCT01313780|Drug|Oxycodone/Naloxone|Dose and administration : Upto 40mg B.I.D per daily.
16210271|NCT01313780|Drug|Oxycodone(single compound)|Dose and administration : Upto 40mg B.I.D per daily.
16210272|NCT01313767|Drug|Botulinum toxin type A|Botulinum toxin type A
16210273|NCT01313767|Drug|Botulinum Toxin type A|Botulinum Toxin type A
16210274|NCT01313754|Procedure|Vicryl Suture|Vicryl suture material will be placed on the patients left sided incision.
16210275|NCT01313754|Procedure|Dermabond|Dermabond skin glue will be placed on the patients left sided incision.
16210276|NCT01313741|Device|Shoulder arthroplasty with anchor peg glenoid|Shoulder arthroplasty with anchor peg glenoid
16210277|NCT01313728|Drug|Dapsone plus Tretinoin Gel|Dapsone gel, followed by tretinoin gel one hour later, applied once daily to the assigned side of the face for 2 weeks
16210278|NCT01313728|Drug|Tretinoin Gel|Tretinoin gel applied once daily to the assigned side of the face for 2 weeks
16210279|NCT01313715|Biological|160U /0.5ml|inactivated vaccine(vero cell) against EV71 of 160U /0.5ml, two doses, one month interval
16210280|NCT01313715|Biological|320U /0.5ml|inactivated vaccine(vero cell) against EV71 of 320U /0.5ml, two doses, one month interval
16210281|NCT01313715|Biological|640U /0.5ml|inactivated vaccine(vero cell) against EV71 of 640U /0.5ml, two doses, one month interval
16210282|NCT01313715|Biological|0/0.5ml placebo|0/0.5ml placebo, two doses, one month interval
16210283|NCT01313702|Drug|polipillV1|polipill version 1: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, atenolol 50mg
16210284|NCT01313702|Drug|polipillV2|Polipill version 2: aspirin 75mg, simvastatin 40mg, lisinopril 10mg, hydrochlorothiazide 12.5mg.
16210285|NCT01313702|Drug|usual care|the drugs used in clinical practice, defined by physician
16210286|NCT01313689|Drug|Ofatumumab|Ofatumumab IV, initial dose 300 mg, followed 1 week later with 2000 mg once weekly for 7 weeks, followed 4 weeks later by one infusion of 2000 mg every 4 weeks for 4 infusions, for a total of 12 infusions over 24 weeks. After 24 weeks of ofatumumab treatment, patients who have achieved at least stable disease or better, and whom the investigator would deem appropriate for the therapy to continue, would undergo a second randomisation (2:1) to either 1) an additional ofatumumab dose regimen of 2000 mg once every 4 weeks for up to an additional 24 weeks, or 2) no further therapy (i.e. observation only).
16210287|NCT01313689|Drug|Physicians' Choice|Non-ofatumumab containing regimen as per physicians' choice for up to 6 months. Permitted therapies include treatments approved for CLL, and well established standards of care for CLL.
16210288|NCT01313676|Drug|fluticasone furoate/vilanterol|100/25mcg given once daily via novel dry powder inhaler
16210289|NCT01313676|Drug|fluticasone furoate|100mcg given once daily via novel dry powder inhaler
16210290|NCT01313676|Drug|vilanterol|25mcg given once daily via novel dry powder inhaler
16210291|NCT01313676|Other|Placebo|placebo comparator once daily via novel dry powder inhaler
16210292|NCT01313663|Drug|pazopanib|oral agent, administered at 800 mg daily (400 mg tablets x 2). Dose can be reduced, interrupted or discontinued due to adverse events or intolerance
16210293|NCT01313663|Drug|pemetrexed|pemetrexed IV 500 mg/m2 once every 3 weeks
16210294|NCT01313650|Drug|62.5/25mcg|GSK573719/GW64244
16210295|NCT01313650|Drug|62.5mcg|GSK573719
16210296|NCT01313650|Drug|25mcg|GW642444
16210297|NCT01313650|Drug|Placebo|Placebo
16210298|NCT01313637|Drug|GSK573719/GW642444 125/25mcg|125/25mcg
16210299|NCT01313637|Drug|GSK573719 125mcg|125mcg
16210300|NCT01313637|Drug|GW642444 25mcg|25mcg
16210301|NCT01313637|Drug|Placebo only|Placebo
16210302|NCT01313624|Drug|AZLI|AZLI 75 mg reconstituted with diluent and administered via nebulizer three times daily
16210303|NCT01313624|Drug|Placebo|Placebo to match AZLI administered via nebulizer three times daily
16210304|NCT01313611|Drug|Rituximab + bendamustine|Induction phase: rituximab and bendamustine on Day 1, Bendamustine on Day 2, Rituximab on Day 8, Rituximab on Day 15, Rituximab on Day 22, bendamustine on Day 29, Bendamustine on Day 30
16210305|NCT01313598|Drug|GLPG0187|continuous IV infusion
16210306|NCT01313585|Drug|Initiation of beclometasone via the Easibreathe device plus salbutamol via the Easibreathe device|
16210307|NCT01313585|Drug|Initiation of beclometasone via the Easibreathe device plus salbutamol via and MDI device|
16210308|NCT01313585|Drug|Increase of beclometasone via the Easibreathe device plus salbutamol via the Easibreathe device|
16210309|NCT01313585|Drug|Increase of beclometasone via the Easibreathe device plus salbutamol via an MDI|
16210310|NCT01313572|Drug|Apadenoson SPECT-MPI|Apadenoson single bolus IV injection 100 or 150 ug
16210311|NCT01313572|Drug|Adenosine SPECT-MPI|Single IV infusion for 6 minutes at a rate of 140 µg/kg body weight per minute
16210312|NCT01313559|Drug|Pasireotide|Given IM
16210313|NCT01313559|Drug|Everolimus|Given PO
16210314|NCT01313559|Other|Laboratory biomarker analysis|Correlative studies
16210315|NCT01313546|Other|Stimulation of quariceps muscle|stimulation of quadriceps muscle through the stimulating catheter
16210316|NCT01313533|Drug|Polyarginine|Vein soak treated with polyarginine
16210317|NCT01313533|Drug|Vein soak treated with Lactated Ringers Solution|Vein soak
16210318|NCT01313520|Drug|Infliximab|3 mg/kg of Infliximab at Weeks 0, 2, 6, 14 via intravenous infusion
16210319|NCT01313520|Drug|Placebo|250 mL of 0.9% sodium chloride at Weeks 0, 2, 6, 14 via intravenous infusion
16210320|NCT01313507|Biological|NewGam|The initial dose and dosing interval for each participant was the dose and dosing interval the participant received at the end of the NGAM-01 study. The dose of NewGam, solvent/detergent treated human normal immunoglobulin 10%, remained the same throughout the study, as long as the minimum trough level of serum immunoglobulin G (IgG) was above 5 g/L. If the serum IgG trough level dropped to 5 g/L or less, the dose was to be adjusted at the investigator's discretion. NewGam was supplied as a solution for infusion.
16210321|NCT01313494|Drug|Roflumilast|Roflumilast tablets
16210323|NCT01313494|Drug|Salbutamol|Salbutamol (given by MDI and spacer) used as rescue medication on an ass needed basis throughout the trial, and was used for post-bronchodilator spirometry tests at all study visits.
16210324|NCT01313481|Behavioral|Group exercise|Otago exercise performed in groups of 4-8 patients, 2 times a week over 12 weeks
16210325|NCT01313481|Behavioral|Home exercise|Otago exercise performed as home exercise 3 times a weeks over 12 weeks. Individually tailored physical balance and muscle strength exercise
16210326|NCT01313468|Behavioral|1 x 4 minute interval|1 x 4 minutes of high intensity intervals at 90-95% of maximal heart rate
16210327|NCT01313468|Behavioral|4 x 4 minutes Intervals|4 x 4 minutes of high intensity intervals at 90-95% of maximal heart rate separated by 3 minutes of active brakes in between at 70% of maximal heart rate.
16210328|NCT01313468|Behavioral|Moderate continuous Training|47 minutes of Moderate continuous Training
16210329|NCT01313429|Drug|Cyclophosphamide|50 mg PO BID for 7 days prior to the first dose of vaccine and then on days 8 through 14, and 22 through 28 of each treatment cycle.
16210330|NCT01313429|Biological|Allogenic tumor Cell Vaccine (K562)|4 vaccines consisting of approximately 2.5E7 cells each will be delivered IM every 4 weeks for 6 months. If immune response is detected after first 6 vaccinations, 2 more may be given at 3 month intervals.
16210331|NCT01313429|Drug|Celecoxib|400 mg PO BID for 7 days prior to the first dose of vaccine and then on days 1 through 28 of each vaccine cycle.
16210332|NCT01313416|Biological|CT-011|3mg/kg, intravenous (IV) day 1 of each cycle over 2 hours.
16210333|NCT01313416|Drug|Gemcitabine|1000mg/m^2 intravenous (IV) over 30 minutes on days 8, 15, and 22 of each cycle.
16210334|NCT01313403|Other|Antidepressant (SSRI)|
16210335|NCT01313390|Drug|docetaxel|
16210336|NCT01313390|Drug|everolimus|
16210337|NCT01313390|Other|laboratory biomarker analysis|
16210338|NCT01313390|Other|pharmacological study|
16210339|NCT01313377|Drug|gemcitabine hydrochloride|
16210340|NCT01313377|Drug|oxaliplatin|
16210341|NCT01313377|Other|clinical observation|
16210342|NCT01313377|Procedure|adjuvant therapy|
16210343|NCT01313377|Procedure|quality-of-life assessment|
16210344|NCT01313364|Device|"25G x 1 Needle Autoinjector"|All subjects will self-administer 4 IM injections using single-use autoinjectors.
16210345|NCT01313325|Other|Hippotherapy|Children will receive treatment by a licensed physical therapist using hippotherapy as the treatment strategy. This includes sitting on a horse who's movement is controlled by a horse leader, with the PT directing the movements required of the horse, as well as supplying supplemental cues to the participant. Alternative positions (such as sitting backward and sideways) may also be used during the treatment session.
16210346|NCT01313312|Biological|Botulinum toxin type A|"Dysport® was supplied to the study centres in vials containing 500 U of botulinum toxin type A (BTX-A). Depending on the dose administered up to 3 vials were required for the injection.
~Each vial was reconstituted with sodium chloride for injection (0.9%). A total volume of 5.0 mL of the reconstituted product was injected for Dysport® 500 U and 1000 U, and 7.5 mL was injected for Dysport® 1500 U."
16210347|NCT01313299|Biological|Botulinum toxin type A|500 U, I.M. (in the muscle) injection on day 1 of a single treatment cycle.
16210348|NCT01313299|Biological|Botulinum toxin type A|1000 U, I.M. (in the muscle) injection on day 1 of a single treatment cycle.
16210349|NCT01313299|Drug|Placebo|I.M. (in the muscle) injection on day 1 of a single treatment cycle.
16210350|NCT01313286|Drug|LY2608204 Reference|Administered orally
16210351|NCT01313286|Drug|LY2608204 Test|Administered orally.
16210352|NCT01313273|Drug|Lanreotide, non steroidal anti androgens and LHRH-a|"Lanreotide 120 mg. Injection every 28 days, to be administered till progression or for a maximum of 24 months.
~Non steroidal anti androgens (e.g. bicalutamide 50 mg/day to be administered till progression) plus LHRH-a (e.g. triptorelin 3.75 mg/month till progression."
16210353|NCT01313273|Drug|Non steroidal anti androgens and LHRH-a|Non steroidal anti androgens (e.g. bicalutamide 50 mg/day to be administered till progression) plus LHRH-a (e.g. triptorelin 3.75 mg/month till progression
16210354|NCT01313247|Drug|paracetamol|1000 mg 4 times daily
16210355|NCT01313247|Drug|placebo tablets|Placebo pills eqv paracetamol are given 2 tablets 4 times daily instead of paracetamol
16210356|NCT01313234|Behavioral|Education|Theory based education and systematic daily assessment
16210357|NCT01313221|Biological|etanercept|Administered by subcutaneous injection
16210358|NCT01313221|Drug|Topical agents|"Topical agents prescribed at the discretion of the Principal Investigator and were are limited to the following:
~hydrocortisone 2.5%
~betamethasone valerate 0.1%
~betamethasone dipropionate 0.05%
~clobetasol 0.05%
~calcitriol
~calcipotriol plus betamethsone dipropionate 0.05%"
16210359|NCT01313208|Drug|etanercept|Administered by subcutaneous injection once weekly.
16210360|NCT01313208|Drug|Placebo|Placebo subcutaneous injection
16210361|NCT01313208|Drug|DMARD Therapy|Standard-of-care DMARD therapy, including methotrexate, sulfasalazine, leflunomide, minocycline, and/or hydroxychloroquine
16210362|NCT01313182|Drug|mupirocin calcium ointment, 2%|"Approximately one-half of the ointment from the single-use tube should be applied into 1 nostril and the other half into the other nostril twice daily (morning and evening) for 5 days.
~After application, the nostrils should be closed by pressing together and releasing the sides of the nose repetitively for approximately 1 minute. This will spread the ointment throughout the nares."
16210363|NCT01313182|Drug|3M Skin and Nasal Antiseptic|The solution is applied to for 30 seconds to each nostril twice for a total of 2 minutes. The solution is applied by rotating the applicator around the circumference of the nostril for 15 seconds and then rotating the applicator in the anterior nares for 15 seconds.
16210364|NCT01313169|Other|EMR Reminder|EMR reminders displayed
16210365|NCT01313169|Other|EMR Reminder + Panel management|EMR Reminder + Panel management
16210366|NCT01313143|Drug|AOP200704|Comparison of AOP200704 with Esmolol
16210367|NCT01313143|Drug|Esmolol hydrochloride, infusion|Comparison of AOP200704 with Esmolol
16210368|NCT01313117|Drug|Alpha lipoic acid|The baseline dose is 100 mg three times daily for four months. Dose escalation will occur until a maximum tolerated dose is found.
16210369|NCT01313104|Procedure|colposcopy|Undergo colposcopy
16210370|NCT01313104|Other|cervical Papanicolaou test|Undergo cervical Pap smear
16210372|NCT01313104|Procedure|screening method|Undergo high resolution anoscopy
16210373|NCT01313078|Drug|Pegylated L-Asparaginase|Pegaspargase 2000 IU/m^2 intramuscular or intravenously every 2 weeks
16210374|NCT01313065|Drug|VX15/2503|Dose escalation will begin at low doses and will gradually increase in each future cohort. The current trial design provides for 7 study cohorts with a 20 mg/kg expansion phase.
16210375|NCT01313052|Behavioral|Forensic Assertive Community Treatment (FACT)|Individuals in this arm will receive the services of an Assertive Community Treatment team and close supervision of a judge trained in the FACT model.
16210376|NCT01313052|Behavioral|Enhanced Treatment as Usual|Individuals in this arm of the study will receive an expedited appointment at a clinic specializing in the treatment of psychotic disorders. These individuals will receive the services of a therapist, psychiatrist, and case manager.
16210377|NCT01313039|Drug|AZ6244|AZD6244 75 mg (3 x 25mg capsules) orally twice per day on Days 1 - 15
16210378|NCT01313026|Procedure|Percutaneous nerve evaluation|Implantation of a nerve stimulator to stimulate the sacral nerve plexus
16210379|NCT01313013|Behavioral|question prompt sheet|
16210380|NCT01313000|Procedure|Autologous fat transfer|Autologous fat transfer from abdomen to upper arms
16210381|NCT01312987|Dietary Supplement|Lipid-based nutritional supplement|"After gradual introduction of the lipid-based nutritional supplement, daily dose per child is as follows:
~3 teaspoons 3 x day for children younger than 12 months 4.5 teaspoons 3 x day for children older than 12 months"
16210382|NCT01312961|Drug|Dupilumab|Solution for injection, one subcutaneous injection.
16210383|NCT01312961|Drug|Placebo (for Dupilumab)|Solution for injection, one subcutaneous injection.
16210384|NCT01312961|Drug|Fluticasone/Salmeterol combination therapy|Oral inhalation twice daily.
16210385|NCT01312961|Drug|Fluticasone monotherapy|Oral inhalation twice daily.
16210386|NCT01312961|Drug|Albuterol|Oral inhalation as needed.
16210387|NCT01312961|Drug|Levalbuterol|Oral inhalation as needed.
16210388|NCT01312948|Device|Prototype mask (known as Pixi)|This is a prototype mask to be used with continuous positive airway pressure (CPAP) or non-invasive ventilation (NIV) therapy. The mask attaches to the face, covering the nose, and is kept in place with headgear. Therapy is delivered through the mask via a tube which attaches to the CPAP or NIV device.
16210389|NCT01312935|Drug|PMX-60056|investigational drug
16210390|NCT01312922|Drug|PNB01 fixed dose combination of pipamperone and citalopram|oral once daily administration
16210391|NCT01312922|Drug|Citalopram|oral once daily administration
16210392|NCT01312922|Drug|Pipamperone|oral once daily administration
16210393|NCT01312909|Drug|Varenicline 1mg BID|Oral Varenicline 1mg BID, or 1/2 that dose (0.5mg BID) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52
16210394|NCT01312909|Drug|Varenicline 0.5mg BID|Oral Varenicline 0.5mg BID, or 1/2 that dose (0.5 QD) for those subjects that weigh less than or equal to 55kg at baseline, for twelve weeks, follow-up through Week 52
16210395|NCT01312909|Drug|Placebo|Oral placebo for twelve weeks,follow-up through Week 52
16210396|NCT01312883|Behavioral|Behavioral education intervention|One education session with a social worker while at the hospital, provision of an educational pamphlet and summary sheet for partner, a needs assessment by the social worker 2 weeks after hospital discharge, and additional patient education and reinforcement of self-management skills, as needed
16210397|NCT01312870|Dietary Supplement|Ensure, Abbott Nutrition|Enteral feeding Ensure, Abbott Nutrition 400 ml per day for seven postoperative days
16210398|NCT01312870|Other|standard hospital diet|standard hospital diet
16210399|NCT01312857|Drug|panitumumab|"All patients receive HAI FUDR (0.12 mg/kg/day X kg X pump volume) / pump flow rate and Dexamethasone flat dose of 25 mg on days 1.
~All patients receive CPT-11 (150 mg/m2 IV over 30 min to an hour), Leucovorin (400 mg/m2 IV, over 30 min to an hour) and 5FU (1000 mg/m2/day continuous infusion over two days) on days 15 and 29 Randomization to panitumumab 6 mg/kg day 15 and 29 Each cycle repeats every 36 days for a total of 6 cycles"
16210400|NCT01312857|Drug|Randomization to No Panitumumab|"All patients receive HAI FUDR (0.12 mg/kg/day X kg X pump volume) / pump flow rate and Dexamethasone flat dose of 25 mg on days 1.
~All patients receive CPT-11 (150 mg/m2 IV over 30 min to an hour), Leucovorin (400 mg/m2 IV, over 30 min to an hour) and 5FU (1000 mg/m2/day continuous infusion over two days) on days 15 and 29 Randomization (to no panitumumab) Each cycle repeats every 36 days for a total of 6 cycles"
16210401|NCT01312844|Drug|Scopolamine|Those receiving active drug will receive scopolamine 4mcg/kg IV with each treatment, until completion of ECT
16210402|NCT01312831|Other|Vitamin B12 (cyanocobalamin)|
16210403|NCT01312818|Drug|Bortezomib|1.3 mg/m^2 by intravenous pyelogram (IVP) over 3-5 seconds on days 1, 4, 8 and 11.
16210404|NCT01312818|Drug|Vorinostat|180 mg/m^2 (max dose 400mg) by mouth (PO) divided twice a day (BID) on days 1-14
16210405|NCT01312818|Drug|Dexamethasone|6 mg/m^2 by mouth (PO) divided twice a day (BID) on days 4-15.
16210406|NCT01312818|Drug|Methotrexate|Intrathecal Methotrexate at age based dose on day 1 (repeat on day 15 or 16 for CNS positive patients only)
16210407|NCT01312818|Drug|Imatinib mesylate|"For Ph+ acute lymphoblastic leukemia (ALL) patients only:
~Imatinib Mesylate is allowable at 340 mg/m2 PO once a day (rounded to the nearest 100 mg) for age ≤18 years and 400 mg for >18 years on Days 1-16."
16210408|NCT01312805|Other|CHICA Asthma Module|This module was added to CHICA to help diagnose and manage asthma
16210409|NCT01312805|Other|CHICA Control|This is CHICA without the asthma module, and was used as a control
16210410|NCT01312792|Other|Amoxycilline, Cephradine followed by follow up on day 3|Modified IMCI Guideline for treating severe phnemonia will be implemented in the arm 1. The Modified IMCI guideline denotes that all severe pneumonia cases with only chest indrawing and no other danger signs will be treated at the first level health facilities with first line oral antibiotics followed by follow-up on 3rd day. On 3rd day the patient will be reassessed and if the condition improves the first line antiobiotic will be continued and if deteriorates or remain unchange second line antibiotic will be used. The patient will be further asked to come on day 3 for reassessment.
16210411|NCT01312792|Other|Injectable ampicillin followed by urgent referral|Existing IMCI guideline denotes all severe pneumonia cases will be referred to the 1st level referral facilities after giving first dose of injectable antibiotics
16213993|NCT01284959|Drug|paliperidone ER|paliperidone ER 6mg, PO,3 times
16210412|NCT01312779|Device|Implantation of CEP Magna Mitral Model 7000TFX|Heart valve surgery: CEP Magna Mitral Model 7000 TFX
16210413|NCT01312766|Drug|Menotropins|Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
16210414|NCT01312766|Drug|Menotropins|Daily administration, SC, starting dose 150 IU or 225 IU depending on patient age.
16210415|NCT01312740|Other|LC-P-LGI diet|a hypocaloric diet low in lipids (25%) which is compensated by proteins (35%) with no change in carbohydrate content.
16210416|NCT01312740|Other|LC-CONV|4-week CONV period consisted in the subjects' consumption of 1200 Kcal/ day (25% protein, 31% lipids, 44% carbohydrates).
16210417|NCT01312727|Other|Blood and urine sample collections|phenotype and genotype analysis, biological analysis
16210418|NCT01312714|Drug|Cholecalciferol|3 tablets of 1000 IU daily for 26 weeks
16210419|NCT01312714|Drug|Placebo|3 tablets of 1000 IU daily for 26 weeks
16210420|NCT01312688|Other|Early Goal Directed Hemodynamic Therapy in Sepsis|Early Goal Directed Hemodynamic Therapy according to the SSC guidelines
16210421|NCT01312675|Device|S.A.F.E.BT|Five (5) S.A.F.E.BT treatments within a 7 day treatment period.
16210422|NCT01312649|Behavioral|Experimental psychology methods (computer tests)|
16210423|NCT01312636|Drug|activated recombinant human factor VII|Data will be collected at the baseline visit and approximately once a year until end of study.
16210424|NCT01312623|Other|Remote ischemic preconditioning|Remote ischemic preconditioning at the left leg.
16210425|NCT01312610|Dietary Supplement|High flavanone orange juice|High flavonone orange juice drink.
16210426|NCT01312610|Dietary Supplement|Control orange juice|Orange beverage, low flavanone content, matched for total carbohydrate content, individual sugar profile, vitamin C
16210427|NCT01312597|Other|Fruit juice beverage|500ml fruit juice beverage, single dose per visit
16210428|NCT01312584|Dietary Supplement|Processed High-flavanol|
16210429|NCT01312571|Behavioral|Internet-based cognitive behavioural therapy (iCBT)|The Internet-based cognitive behavioural therapy (iCBT) consists of our structured self-help program lasting a total of nine active treatment weeks. This treatment program has been well evaluated and involved in several research projects.
16210430|NCT01312571|Behavioral|Internet-based computerized attention training|The Internet-based computerized attention training program lasting a total of four active treatment weeks. The treatment is consist of two training sessions per week, about 10 minutes long.
16210431|NCT01312558|Behavioral|Prudent diet group|
16210432|NCT01312558|Behavioral|Mediterranean diet group|
16210433|NCT01312545|Device|3DP|intervention involving local made implant with different fabricating technique-3-dimensional printing (3DP) technique.
16210434|NCT01312545|Device|Medpor|commercial porous polyethylene
16210435|NCT01312532|Device|fixed-bearing (P.F.C.® Sigma)|P.F.C.® Sigma, DePuy, Johnson & Johnson, Leeds, UK
16210436|NCT01312532|Device|mobile-bearing (P.F.C.® Sigma)|P.F.C.® Sigma, DePuy, Johnson & Johnson, Leeds, UK
16210437|NCT01312519|Device|OnControl Bone Marrow Biopsy and Aspiration System|Battery powered device used for insertion of a single lumen catheter into the intraosseous space of the adult iliac crest for the purpose of aspiration and core biopsy collection.
16210438|NCT01312519|Device|Manual bone marrow sampling device|Hollow needle with a t-shaped handle that is pushed into the bone for the purpose of collecting bone marrow aspiration and core biopsy samples.
16210439|NCT01312493|Drug|Panitumumab|Weekly panitumumab intravenously at a dosage of 2.5 mg/kg started one week prior to RT until RT is completed. No more than 8 treatments.
16210440|NCT01312493|Radiation|Intensity Modulated Radiation Therapy|The dose per fraction will be 2 Gy per day. Thus, the total number of fractions will be 35. Five days a week for 7 weeks.
16210441|NCT01312480|Other|5A's Model|"The smoking cessation intervention is based on the 5A's model, which includes the following elements:
~Ask if the patient smokes.
~Advise every patient to quit.
~Assess readiness to quit.
~Assist in quitting and finding services.
~Arrange for cessation services and follow-up."
16210442|NCT01312480|Other|Media Use Assessment|The media use assessment (control condition) is based in part on the American Academy of Pediatrics policy statement on children and media, published in the November 2010 issue of Pediatrics. This assessment includes suggested questions on how much media per day is used and whether or not the adolescent has a television or Internet access in his/her bedroom. The adolescent will complete a one-page Media Use assessment form for this purpose, which will set the stage for relevant anticipatory guidance.
16210443|NCT01312467|Drug|metformin hydrochloride|
16210444|NCT01312454|Drug|AL-59412C injectable solution|Concentration 1 and Concentration 2
16210445|NCT01312454|Drug|Travoprost injectable solution|
16210446|NCT01312454|Drug|AL-59412C Vehicle|Inactive ingredients used as placebo
16210447|NCT01312441|Drug|Ergocalciferol|Ergocalciferol capsules 50,000 IU once weekly for 6 months
16210448|NCT01312441|Drug|Placebo|Placebo by mouth once weekly for 6 months
16210449|NCT01312428|Device|Pelvic Alignment Level (PAL) Instrument|Pelvic Alignment Level Instrument Used
16210450|NCT01312428|Device|No Pelvic Alignment Level (PAL) Instrument|No Pelvic Alignment Level Instrument Used
16210451|NCT01312415|Drug|Levobupivacaine|Patients will receive peri- and intraarticular surgical site infiltration to the knee during surgery and before wound closure with a solution of levobupivacaine 0.5% 2mg/kg body weight (maximum 200mg levobupivacaine will be used if the patient's weight exceeds 100kg) plus 0.5mg epinephrine made up to 100ml with saline. An intra-articular catheter will be placed by the surgeon before closure under the sterile surgical conditions and this will be left in situ in the wound. The patient will receive one further injection of 15ml of levobupivacaine 0.5% solution at 8am on the morning of the first postoperative day after which the catheter will be removed.
16210452|NCT01312415|Drug|Intrathecal morphine|Patients will receive spinal anaesthesia with intrathecal bupivacaine 0.5% (17.5 mg if greater than 70 kg and 15 mg if less than 70 kg) and preservative-free morphine (0.3 mg).
16210453|NCT01312402|Drug|topical brinzolamide 1% in 5mL ophthalmic medication|1 drop three times a day in both eyes on days 2,3 and 4
16210454|NCT01312402|Drug|Placebo in 5 mL dispenser|Placebo ophthalmic solution in 5 mL dispenser; 1 drop three times a day on days 2,3 and 4
16210513|NCT01311882|Drug|Grossly Matching Placebo for Zopiclone|Grossly Matching Placebo for Zopiclone
16210514|NCT01311882|Drug|Matching Placebo for MK-4305|Matching Placebo for MK-4305
16210455|NCT01312389|Biological|OC-L/Montanide ISA 51 VG|All subjects will receive OC-L/Montanide ISA 51 VG) on day 0, 14,28,42 and 56 with a +/- 5 day window. The vaccine will be divided in two or more intradermal/subcutaneous injections in the groin areas bilaterally.
16210456|NCT01312389|Biological|Ampligen|All subjects will receive intravenous Ampligen (200mg given by IV infusion 60 +- minutes) 3 times starting 2-3 days after each vaccine administration. Each of the 3 Ampligen (200 mg) infusions will be separated by 2-3 days.
16210457|NCT01312389|Biological|Prevnar|A vaccine against Pneumococcus pneumoniae will be given intramuscularly on Day 0 and 14 as positive control of immune responsiveness.
16210458|NCT01312376|Biological|OC-DC vaccine|All subjects will receive a dose of 5-10 million cells of OC-DC intradermally
16210459|NCT01312376|Drug|Bevacizumab|Patients will start receiving Bevacizumab at 15 mg/kg starting Day 30 and every 4 weeks thereafter until end of study.
16210460|NCT01312376|Drug|cyclophosphamide 300 mg/m2/d for 3 days|All subjects will receive a single course of outpatient lympho-depleting chemotherapy with intravenous cyclophosphamide for 300 mg/m2/d for 3 days.
16210461|NCT01312376|Drug|fludarabine 30 mg/m2/d for 3 days|All subjects will receive a single course of outpatient lympho-depleting chemotherapy with intravenous fludarabine 30 mg/m2/d for 3 days
16210462|NCT01312376|Drug|ex vivo CD3/CD28-costimulated vaccine-primed peripheral blood autologous T cells|All subjects will receive a single intravenous infusion of ex vivo CD3/CD28-costimulated vaccine-primed peripheral blood autologous T-cells at the starting dose of 10-15 x 109 (10-15 billion) T-cells with escalating doses in cohort 2 and 3.
16210463|NCT01312363|Drug|Rivastigmine patch|Rivastigmine patch (5-10cm2, daily, 24hr)
16210464|NCT01312350|Drug|neoadjuvant docetaxel/cisplatin/fluorouracil|2 cycles of neoadjuvant Docetaxel/cisplatin/5-fluorouracil therapy followed by CCRT Neoadjuvant chemotherapy (docetaxel 75mg/m2 D1, cisplatin 75mg/m2 D1, 5-fluoruracil 759mg/m2/day, D1-4, every 3 weeks) CCRT protocol is same with that of control arm.
16210465|NCT01312350|Drug|No treatment before definitive CCRT|concurrent chemoradiation therapy radiation: 70Gy/35fractions chemotherapy: cisplatin single 100mg/m2/day D1, D22, D43
16210466|NCT01312337|Drug|salvage iressa|Iressa 250mg per day until progression
16210467|NCT01312324|Drug|neoadjuvant docetaxel/cisplatin|3 cycles of docetaxel plus cisplatin docetaxel 75mg/m2 D1 cisplatin 75mg/m2 D1 every 3 weeks
16210468|NCT01312311|Drug|Docetaxel, Cisplatin|Docetaxel 35mg/m2 D1 & D8 Cisplatin 70mg/m2 D1
16210469|NCT01312298|Procedure|General anesthesia|Patients will receive general anesthesia using propofol 10 mg/ml and remifentanil 50 ug/ml
16210470|NCT01312298|Procedure|Regional anesthesia|Patients will receive intrathecal anesthesia
16210471|NCT01312285|Device|Resonator device|low level magnetic fields
16210472|NCT01312272|Drug|Oxytocin|Oxytocin 40 units/ml nasal spray: use 5 sprays per nostril (40 IU total) one time
16210473|NCT01312272|Drug|Inactive placebo nasal spray|A placebo nasal spray will be prepared identically to the oxytocin nasal spray except lacking oxytocin. Its ingredients are mannitol, glycerin, and preserved water. It will be administered at 5 sprays to each nostril, one time.
16210474|NCT01312259|Other|"Changing the Interstim parameter of '' Frequency in patients with Interstitial Cystitis"|Subjects will be randomized into one of two groups. Group One will be programmed to receive 14 Hz as their frequency, while the other group (Group 2) will receive 40 Hz as their frequency for the first ninety days after surgical implantation. After three months each patient will come in to the office to have their InterStim frequency changed to the opposite frequency. After each patient has had three months to evaluate each of the two frequencies, the next step is to allow the patient to decide which setting they thought best controlled their respective symptoms. The InterStim was then programed to whichever frequency the patient chose, and this would remain for three to six months.
16210475|NCT01312246|Device|EnSeal Device|measurement of bursting pressure of colonic vessels after using the EnSeal Device
16210476|NCT01312233|Other|Medical Care|Participants allocated to all three treatment groups receive medical care over a 12-week period. Medical treatments are standard therapies for back pain. Medical and osteopathic physicians follow clinical practice guideline recommendations for back pain: focused history and physical exam; limited diagnostic imaging; self-management education; maintaining physical activity as tolerated and local heat/cold application; pharmacotherapy with analgesics and anti-inflammatory agents. Participants not responding to treatment may receive additional therapies such as physical therapy or specialist referral.
16210477|NCT01312233|Other|Dual Care|Participants allocated to Dual Care receive medical care as described plus chiropractic care over a 12-week period. Chiropractic care includes standard therapies for back pain. A doctor of chiropractic determines the therapeutic approach based upon a participant's clinical presentation. Treatments may include spinal or extremity joint manipulation, such as: high velocity-low amplitude or low velocity-variable amplitude maneuvers; mechanical device assisted adjustments; or passive mobilization. Recommendations for exercise, lifestyle modifications, or other therapies may be provided.
16210478|NCT01312233|Other|Shared Care|Participants allocated to Shared Care receive co-managed medical care from a medical or osteopathic doctor and chiropractic care from a doctor of chiropractic over a 12-week period. The medical and chiropractic treatments are standard therapies for back pain, as described under Medical Care and Dual Care.
16210479|NCT01312194|Procedure|Root canal therapy in one visit|Patient was anesthetized with local anesthetic solutions, and the caries was removed. The tooth was isolated with rubber dam and access to pulp chamber was completed. Cleaning and shaping preparation was achieved with manual and rotatory endodontic instruments.The ideal working length was determined by an electronic apex locator and periapical radiography. Irrigation was performed with 5.25%NaOCl solution. The smear layer was removed by 10% citric acid. The cases were obturated with guta-percha cones using a lateral compaction filling technique as well as zinc oxide-eugenol-based root canal sealer. The teeth filled with a light-cured resin.
16210480|NCT01312194|Procedure|Root Canal Therapy in two-vist|The treatment protocol was the same as described for one visit group. In the first visit, after cleaning, shaping and smear layer removal, the root canals were medicated with a calcium hydroxide paste and sterile distilled water (1:1) and the pulp chamber was sealed with a minimum 3mm thickness temporary filling restoration. After 10-12 days, during the second visit, the medication was removed, and the cases were obturated with guta-percha cones using a lateral compaction filling technique as well as zinc oxide-eugenol-based root canal sealer. The teeth filled with a light-cured resin.
16210583|NCT01311284|Device|Macintosh laryngoscope|intubate with the macintosh laryngoscope
16210481|NCT01312181|Behavioral|HealthCall and Motivational Interviewing|Patients access HealthCall by calling a toll-free number and putting a four-digit Personal Identification Number (PIN). The HealthCall system will then ask a short script of pre-recorded questions in English or Spanish, on substance use and other variables (e.g., medication adherence, unprotected sex, feeling of physical well-being, stress, etc). The MI session focuses on reduce ambivalence and increase motivation to reduce non-injection drug use (NIDU), gain a commitment to change, if possible, and ultimately to reduce or eliminate NIDU. The intervention includes: a) identifying pros and cons of using and stopping; b) exploring ambivalence about stopping NIDU; c) eliciting change talk
16210482|NCT01312181|Behavioral|Motivational Interviewing (MI)|The MI session focuses on reduce ambivalence and increase motivation to reduce non-injection drug use (NIDU), gain a commitment to change, if possible, and ultimately to reduce or eliminate NIDU. The intervention includes: a) identifying pros and cons of using and stopping; b) exploring ambivalence about stopping NIDU; c) eliciting change talk
16210483|NCT01312181|Behavioral|HIV/AIDS health education|The purpose of this condition is to control for clinical attention associated with Motivational Interviewing (MI)participation, and to provide an analogue of standard care, i.e. brief advice but no other intervention.
16210484|NCT01312168|Device|Therapeutic CPAP|CPAP ventilator, optimal pressure decided by CPAP manual titration, daily use at sleep, six months
16210485|NCT01312168|Device|Subtherapeutic CPAP|Subtherapeutic CPAP ventilator, pressure <3 cmH2O, daily use at sleep, six months
16210486|NCT01312155|Other|Intubation|Intubation, endotracheal
16210487|NCT01312129|Drug|Sulfasalazine|500mg capsules of Sulfasalazine x 3 doses 12 hours apart.
16210488|NCT01312129|Drug|Placebo|Placebo capsule x 3 doses 12 hours apart
16210489|NCT01312116|Behavioral|iCBT|Internet-delivered cognitive behavior therapy, 8 weeks
16210490|NCT01312116|Behavioral|iPDT|Internet-delivered psychodynamic therapy, 8 weeks
16210491|NCT01312103|Behavioral|Internet-based safety decision aid|"Participants will log into the the intervention website at baseline, 3 months, 6 months, and 12 months post baseline and receive:
~Setting of priorities for safety; a sliding bar allows participants to establish priorities by making pairwise comparisons of importance between factors.
~Danger Assessment; asks women to report on well-established risk factors for repeat violence and lethal IPV. A weighted scoring algorithm provides participants with their validated level of danger.
~Personalized action plan. Based on a participant's answers to the previous sections, a list of safety strategies with links to resources will be presented to her. The participant is given the option to print her results and the personalized plan."
16210492|NCT01312103|Behavioral|Usual Care Safety Plan|"Participants will log into a control website at baseline, 3 months, 6 months and 12 months post baseline. Website will include the usual services provided to IPV survivors looking for safety planning resources on the internet. Participants will receive:
~Danger Assessment, will see risk factors associated with lethal violence, but will not receive a score or feedback.
~A brief emergency safety plan with links to national and state domestic violence resources as well as a suicide resource."
16210493|NCT01312090|Biological|Whole body cryotherapy|Cryotherapy: The whole-cody cryotherapy device (Univers Cryo-Combi;Oy MJG Univers Ab, Helsinki, Finland) consists of 3 chambers set at different temperatures. The first 2 chambers are meant for precooling (-30°Cand-60°C), and the patient remains in these for a very short time. The third chamber temperature reaches -110°C, and the patient remains inside for 3-4 minutes wearing a bathing suit or trunks, acral parts covered.
16210494|NCT01312090|Behavioral|counseling and behavioral therapy for weight loss|Weight loss intervention with Very Low Calory Diet (VLCD, 500-1000 kcal / d + dietary supplements) and group and individual treatment (eating, physical activity counseling and behavioural therapy).
16210495|NCT01312077|Drug|Levobupivacaine|peri- and intraarticular surgical site infiltration before wound closure with a solution of levobupivacaine 0.5% 2mg/kg body weight with epinephrine made up to a volume of 1.5ml/kg with saline. A catheter will be placed by the surgeon before closure under the sterile surgical conditions and this will be left in situ in the wound. An elastomeric pump will deliver a continuous infusion of levobupivacaine 0.25% at 4ml/hr commencing 6 hours postoperatively and continuing for 24 hours.
16210496|NCT01312077|Drug|Intrathecal morphine|intrathecal morphine bolus 200 micrograms
16210497|NCT01312064|Drug|rituximab and everolimus|rituximab (375mg/m2) induction and subsequently everolimus-based immunosuppressive therapy. Everolimus initial dose: 1 mg bid within 24 hrs after reperfusion, adjusted to a target trough blood level of 6-10 ng/ml for the first 6 months after transplantation.
16210498|NCT01312064|Drug|thymoglobulin and tacrolimus|thymoglobulin induction and tacrolimus-based immunosuppressive therapy. thymoglobulin dose: 1.0mg/kg/d for 3 days daily dose of tacrolimus: 0.15 mg/kg/d given in two doses starting within 24 hours after transplantation
16210499|NCT01312038|Drug|Simethicone|single 125 mg chewable tablet
16210500|NCT01312038|Drug|Placebo|chewable calcium tablet
16210501|NCT01312025|Procedure|conventional laparoscopic cholecystectomy|
16210502|NCT01312025|Procedure|modified laparoscopic cholecystectomy|
16210503|NCT01312012|Drug|antiviral therapy|100-120 pregnant women seropositive for both HBeAg and HBsAg and with hepatitis B viral DNA level > 10 8 copies/mL. Among them, 55-65 pregnant women will receive TDF therapy 300 mg once daily, starting from the gestational age 30-32 (the 3rd trimester) until 4 weeks after delivery of the neonate under informed consent. The total treatment duration will be 3-4 months. Another 45-55 pregnant women with the same serum HBAg and HBsAg and HBV DNA status will be enrolled as the control group with no TDF therapy ( An open-labeled study)
16210504|NCT01311960|Drug|bevacizumab eye drop 0.05%|bevacizumab eye drop 0.05% will apply 4 times a day for 3 months
16210505|NCT01311960|Drug|normal saline 0.9%|normal saline eye drop 0.9% will apply 4 times a day for 3 months.
16210506|NCT01311947|Drug|Peginterferon alfa-2a|Peginterferon alfa-2a at 180 ug weekly for 24 weeks
16210507|NCT01311908|Procedure|Methods of gastrojejunostomy reconstruction|Roux-en-Y reconstruction in pancreaticoduodenectomy
16210508|NCT01311895|Drug|H2O|2 mg IV hydromorphone
16210509|NCT01311895|Drug|1+1|"1mg I hydromorphone followed by an optional 1 mg IV hydromorphone 15 minutes later if the patient answers yes to the question, Do you want more pain medication?"
16210510|NCT01311882|Drug|MK-4305 40 mg|4 x 10 mg MK-4305 tablets
16210511|NCT01311882|Drug|MK-4305 20 mg|2 x 10 mg MK-4305 tablets
16210512|NCT01311882|Drug|Zopiclone|1 x 7.5 mg Zopiclone tablet
16210515|NCT01311869|Dietary Supplement|EGCG ( Green Tea extract)|A randomized double-blind placebo-controlled clinical trial will be conducted with 80 women of reproductive age,the 80 women will be allocated into two groups, 40 each. Each group will be given one of two interventions: The first is 2 capsules of (EGCG which is green tea extract, taken orally with food on daily basis for 6 months, each capsule contain 326.25 mg decaffeinated EGCG,The second group will receive matched (color, taste and texture) placebo for a period of 6 months.
16210516|NCT01311869|Dietary Supplement|Brown rice pills|40 subjects will receive 800 mg EGCG orally daily for 6 months, the other 40 subject will receive brown rice pills for the same duration.
16210517|NCT01311856|Behavioral|Standard Arm (mail/telephone)|Participants will receive print materials on diet and exercise, telephone counseling calls (3 weekly calls, 2 semi-weekly calls, 4 monthly calls; 15-30 minutes in length), and customized mailed progress reports every 6 weeks to adhere to diet and exercise recommendations.
16210518|NCT01311856|Behavioral|Internet Arm|Participants will access print information online. Participants will also participate in a discussion forum facilitated by the intervention staff, have the opportunity to email questions directly to the intervention staff, and receive progress reports every 6 weeks by email.
16210519|NCT01311856|Behavioral|Surveys and Questionnaires|9 online surveys to be completed before intervention sessions. After 14 weeks on study, questionnaires will be mailed for completion at home and mailed back to the study staff.
16210520|NCT01311856|Behavioral|Exercise and Diet|15 minutes of strength exercise every other day, >30 minutes of walking or other moderate-intensity exercise on 5 or more days of the week. Diet recommendations for both groups.
16210521|NCT01311830|Behavioral|Telephone Counseling|
16210522|NCT01311830|Behavioral|Written Materials|
16210523|NCT01311817|Biological|BMB72 (actA/plcB-deleted Listeria monocytogenes expressing influenza A nucleoprotein)|1mL liquid contained in an adhesive skin patch
16210524|NCT01311804|Procedure|parecoxib sodium|periarticular parecoxib sodium injection will be given during total knee arthroplasty
16210525|NCT01311804|Procedure|parecoxib sodium|intravenous parecoxib sodium during total knee arthroplasty
16210526|NCT01311791|Device|Algisyl-LVR|Algisyl-LVR™ device (implants) administered during a surgical procedure
16210527|NCT01311791|Drug|Standard medical therapy|as defined per protocol
16210528|NCT01311778|Drug|Cannabidiol|"Subjects in Arm CBD 400 mg will receive 400 mg of Cannabidiol in two test sessions along with 0.5 mcg/kg and 1mcg/kg of fentanyl.
~Subjects in Arm CBD 800 mg will receive 800 mg of Cannabidiol in two test sessions along with 0.5 mcg/kg and 1mcg/kg of fentanyl."
16210529|NCT01311778|Drug|Fentanyl|All subjects will receive 0.5 mcg/kg and 1mcg/kg of Fentanyl (test session 1 and test session 2)
16210530|NCT01311765|Other|Duration of antibiotic therapy limited to 8 days|Initiation of adequate empiric antibiotics for postoperative peritonitis within 24 hours after surgery and up to 8 days. At randomisation performed on day 8, the patients assigned to the 8-day group (short-course group) stop their treatment
16210531|NCT01311752|Procedure|surgical management of high grade lesions|"Clinical, pathological and biological, data at diagnosis and during follow-up will be collected.
~Surgical sample will be collected to study human papillomavirus related genital pathology."
16210532|NCT01311739|Drug|Cyanocobalamin|
16210533|NCT01311713|Drug|CEP-9722|CEP-9722 is administered daily or twice-daily for six 28-day cycles. Dose escalation will proceed until the MTD is identified.
16210534|NCT01311713|Drug|CEP-9722|CEP-9722 is administered daily or twice-daily for six 28-day cycles. Patients will be administered CEP-9722 at the MTD identified in Part 1.
16210535|NCT01311700|Drug|Injectable (i.v.) metoprolol tartrate (up to 15 mg).|"Patients are randomized to active intervention (early metoprolol initiation strategy) or no treatment (delayed metoprolol initiation strategy).
~Patients randomized to early metoprolol initiation strategy receive up to three 5mg i.v. dosages (2 minutes apart) before reperfusion.
~Patients randomized to delayed metoprolol initiation strategy receive no active treatment before reperfusion.
~Patients in both groups receive oral metoprolol tartrate treatment (25-100mg/12h), starting 12-24 hr post-reperfusion."
16210536|NCT01311687|Drug|pomalidomide|4 mg pomalidomide capsules administered orally
16210537|NCT01311687|Drug|Dexamethasone|40 mg dexamethasone (or 20 mg for participants > 75 years of age) tablets administered orally
16210538|NCT01311674|Biological|hepatitis B vaccine|Primary vaccination series 20 µg/1.0 mL at baseline, month 1, month 6; followed by booster vaccinations 20 µg/1.0 mL
16210539|NCT01311674|Biological|hepatitis B vaccine|Primary vaccination series 40 µg/2.0 mL at baseline, month 1, month 2, month 6; followed by booster vaccinations 20 µg/1.0 mL
16210540|NCT01311661|Drug|Placebo twice daily|Inhaled Placebo of Olodaterol twice daily
16210541|NCT01311661|Drug|Olodaterol low daily dose twice daily|Inhaled Olodaterol medium daily dose administered as low dose twice daily
16210542|NCT01311661|Drug|Olodaterol medium daily dose twice daily|Inhaled Olodaterol high daily dose administered as medium dose twice daily
16210543|NCT01311661|Drug|Placebo twice daily|Inhaled Placebo of Olodaterol twice daily
16210544|NCT01311661|Drug|Olodaterol high daily dose once daily and placebo|Inhaled Olodaterol high daily dose administered as one full dose once daily and placebo once daily
16210545|NCT01311661|Drug|Olodaterol medium daily dose once daily and placebo|Inhaled Olodaterol medium daily dose administered as one full dose once daily and placebo once daily
16210546|NCT01311648|Biological|Recombinant Factor VIII (Kovaltry, BAY81-8973)|Main study: 25-50 IU/kg at least 2x/week for 6 months and at least 50 EDs, IV infusion; Extension study: 25-50 IU/kg at least 2x/week for at least 100 cumulative EDs (main study - Part A and extension study), IV infusion. Exposure day (ED): An ED is a unit of time (1 day) in which replacement treatment of Hemophilia is given to a patient.
16210547|NCT01311648|Biological|Recombinant Factor VIII (Kovaltry, BAY81-8973)|Main study: 15-50 IU/kg at least 1x/week for at least 50 EDs or until inhibitor development, IV infusion; Extension study: For participants having reached at least 50 EDs in main study - Part B: 25-50 IU/kg at least 2x/week for at least 100 cumulative EDs (main study - Part B and extension study), IV infusion. For participants who developed an inhibitor in main study - Part B: up to 200 IU/kg per day or 100 IU/kg twice a day at the discretion of the investigator and coordinating investigator until successful eradication of the inhibitor, or until failure, for up to18 months (treatment beyond 18 months required an agreement with the sponsor and coordinating investigator), IV infusion
16210584|NCT01311284|Device|McGrath|Intubate with McGrath device
16210548|NCT01311635|Drug|AZD1981, current small-particle tablet|3x100 mg per oral, single dose in fasted state
16210549|NCT01311635|Drug|AZD1981, new small-particle tablet|3x100 mg per oral, single dose
16210550|NCT01311635|Drug|AZD1981, new large-particle table|3x100 mg per oral, single dose in fasted state
16210551|NCT01311622|Drug|warfarin|2 single 25 mg doses of Warfarin (5 x 5 mg tablets) administered 14 days apart
16210552|NCT01311622|Drug|fostamatinib|2 x 50 mg Fostamatinib tablets (100 mg) twice daily for 13 days
16210553|NCT01311609|Other|Systane|Systane Lubricant Eye Drops [1-2 Drops in each eye four times daily (QID)]
16210554|NCT01311596|Other|Icons|Clinic- patients first shown picture icons of the steps of taking vital signs Lab - patients first shown picture icons of the steps of a blood draw procedure
16210555|NCT01311583|Behavioral|Teach Back method of patient discharge teaching|Trained nurses will provide Teach Back to the intervention group. Appendix D lists the four questions that will be used in this study to confirm the patient's understanding. The nurses' training will focus on the concepts of Teach Back, provide coaching and guidance on how to use it as well as review the principles of conducting research. Role play will be a feature in the education sessions to improve the nurses' comfort level
16210556|NCT01311570|Drug|Buprenorphine|"In the first 2 weeks all subjects will enter into a dose titration phase, starting with minimum dosage of 1mg/day Buprenorphine gradually increasing to 4-8 mg/day according to tolerance and clinical benefit.
~From week 3 to week 8, all subjects are prescribed Buprenorphine sublingually, OID in a stable dosage according to the decision of the treating physician."
16210557|NCT01311557|Biological|Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed|0.5 mL, Intramuscular
16210558|NCT01311557|Biological|Adacel®: Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Adsorbed|0.5 mL, Intramuscular
16210559|NCT01311531|Procedure|Open reduction and fixation with TriMed fragment-specific system|Anatomical reduction, achieved by the open technique.
16210560|NCT01311531|Procedure|Open reduction and fixation with TriMed volar locking plate|Anatomical reduction, achieved by the open technique.
16210561|NCT01311518|Drug|Drug: Placebo|Injectable administration by slow intravenous bolus, 0.00% Thymosin Beta 4 daily for 3 days then weekly for 4 consecutive weeks
16210562|NCT01311518|Drug|Drug: Injectable Thymosin beta 4|Injectable administration of Thymosin Beta 4 by intravenous bolus at 1200 mg, or 450 mg daily for 3 days then weekly for 4 consecutive weeks
16210563|NCT01311505|Drug|Myrin© 2 (Rifampicin + Isoniazid)|Two (2) fixed-dose combination tablets each containing Rifampicin 150 mg and Isoniazid 75 mg
16210564|NCT01311505|Drug|Rimactane® (Rifampicin)|One (1) capsule of Rifampicin 300 mg
16210565|NCT01311492|Behavioral|Healthy Lifestyle Program|"The healthy lifestyle program includes upper body stretching and educational workshops. The purpose of this group is to control for general levels of staff and participant time and attention, in addition to general secular and seasonal effects that could influence the outcomes of interest. The rational for this placebo exercise activity is that it helps foster adherence to this arm of the study and increases the perceived benefit of the healthy lifestyle program to the participants without directly affecting the study outcomes."
16210566|NCT01311492|Behavioral|Physical Activity Intervention|The physical activity intervention consists of a general weekly physical activity goal of 150 minutes. This is consistent with the public health message from the Surgeon General's report that moderate physical activity should be performed for 30 minutes on most if not all days of the week (150-210 total minutes). This goal is approached in a progressive manner over the course of the trial.
16210567|NCT01311479|Procedure|Osteopathic Manipulation Therapy|"Subjects will then be treated based on the objective findings of the examination. Since the structural exam includes the whole body, other structural abnormalities will likely be identified and possible require treatment to aid in treatment of SIJ. Subjects will also be taught stretching routines in order to aid in treatment of the dysfunction.
~Our control group will receive the same structural exam, and focused examination. Their treatment will involve massage, in an area not associated with the musculature of the SIJ. This will serve to identify a possible placebo effect, associated with simply providing a healing touch without focused treatment."
16210568|NCT01311466|Procedure|Liver transplantation|
16210569|NCT01311440|Other|Modified Atkins diet treatment|Eat a diet containing 16 grams of carbohydrates per day, maximize on fat. Assure sufficient intake of micronutrients.
16210570|NCT01311427|Behavioral|8-form Yang-style Tai chi|This study tested a modified 8-form Yang-style Tai chi program in subjects with fibromyalgia. Participants met in a small group two times weekly for 60 minutes over 12 weeks.
16210571|NCT01311427|Behavioral|Group education|Standard group education was delivered to participants in a small group format twice weekly for 60 minutes over 12 weeks.
16210572|NCT01311414|Drug|cafedrine/theodrenaline, urapidil|Increasing blood pressure using cafedrine/theodrenalin and decreasing blood pressure using urapidil during carotid endarterectomy.
16210573|NCT01311401|Other|NONE intervention|NONE intervention
16210574|NCT01311375|Dietary Supplement|w3 supplement in SCI|"supplements(Mor DHA and Ca 500 mg -D200 micro g )( will be given in this group"
16210575|NCT01311375|Other|placebo|placebo+ capsule CA-D
16210576|NCT01311362|Drug|St. Johns wort|"Administration of ambrisentan: 5 mg p.o. q.d. on day 1 and days 3-20
~Administration of SJW: 300 mg p.o. three times a day (t.i.d.) on days 11-20"
16210577|NCT01311336|Drug|Loratadine|loratadine 10 mg capsule orally once daily for 7 days beginning the day of administration of pegfilgrastim
16210578|NCT01311336|Drug|placebo|placebo capsule orally once daily for 7 days beginning the day of administration of pegfilgrastim
16210579|NCT01311323|Procedure|PCI|Percutaneous Coronary Intervention with contemporary drug eluting stent, fractional flow reserve or iFR measurement and optimisation with intravascular imaging
16210580|NCT01311323|Procedure|CABG|Coronary Artery Bypass Graft
16210581|NCT01311310|Other|RIPC (remote ischemic preconditioning)|RIPC will be performed by four 5-min cycles of lower limb ischemia and 5 in reperfusion using blood-pressure cuff inflated to a pressure 15 mmHg greater than the systolic arterial pressure measured via arterial line.
16210582|NCT01311284|Device|Macintosh laryngoscope, Airtraq NT, Mcgrath laryngoscope|Each participant will use the Macintosh laryngoscope (blade No. 3), laryngoscope Airtraq NT and Mcgrath Laryngoscope under conditions of normal and difficult airway in different simulated scenarios.
16210585|NCT01311284|Device|Airtraq Nasotracheal|intubate with Airtraq Nasotracheal
16210586|NCT01311271|Device|repetitive transcranial magnetic stimulation (rTMS)|"1 Hz frequency, 15 minutes, intensity of 90% resting motor threshold, with one session a day,
~Real: unaffected M1 hotspot
~Sham: coil perpendicular to scalp"
16210587|NCT01311245|Behavioral|Stage-tailored intervention|Based on the Trans-Theoretical Model of intentional behavior change (TTM). According to their stage of change, participants received two computer generated feedback letters on their risky drinking, stage of change, processes of change, self-efficacy, and decisional balance. The first letter included normative feedback (interpersonal comparison with other individuals in the same stage), and was sent out by mail after baseline. The second letter included normative and ipsative feedback (intrapersonal comparisons: baseline vs. 3 months later), and was sent out by mail three months later.
16210588|NCT01311245|Behavioral|Non-stage-tailored Intervention|Based on the Theory of Planned Behavior (TPB). Participants received two computer generated feedback letters on their risky drinking, beliefs (behavioral, normative, control), attitude, subjective norm, perceived behavioral control, intention, and they were asked to fill in a where-when-how to change plan. The first letter included normative feedback (interpersonal comparison with other women/ men), and was sent out by mail after baseline. The second letter included normative and ipsative feedback, and was sent out by mail three months later.
16210589|NCT01311219|Other|Non-operative Treatment|A figure-of-8 brace will be applied to afflicted extremity in clinic. The patient will be instructed on proper application of the brace and asked to continue wearing the brace for 2 to 6 weeks, depending on the patient's level of comfort.
16210590|NCT01311219|Procedure|Operative Treatment-Plate Fixation|Plate fixation of the clavicle fracture will be performed utilizing a 3.5-mm dynamic compression plate.
16210591|NCT01311219|Procedure|Operative Treatment-Intramedullary Pinning|Clavicle fracture will be repaired through intramedullary pinning using The Rockwood Clavicle Pin (DePuy Orthopaedics, Warsaw, IN).
16210592|NCT01311206|Other|partial blood flow restriction|Partial Blood Flow Restriction (PBFR) Low-Intensity Exercise: using the Biodex 3 Dynamometer in isotonic mode at 10% (first 3 weeks), 15% (following 3 weeks) and 20% (final 3 weeks) of their 1RM for each side, while receiving PBFR in each exercising limb. The padded belts (65 mm in width and 650 mm in length) of the Kaatsu Master™ PBFR device (Sato Sports Plaza, Tokyo, Japan) will be applied to the proximal thigh as near to the hip joint as is comfortable. Before training each leg, subjects will be seated in a chair where an initial belt pressure of 37-40 mmHg will be applied. The belt then will be iteratively pressurized for 30 seconds and then relaxed for 10 seconds in increments of 20 mmHg from 100 mmHg to the final pressure of 160 mmHg. During exercise, the cuff pressure will be continuously controlled and monitored by the PBFR apparatus
16210593|NCT01311206|Other|Low intensity exercise without partial blood flow restriction|Low-Intensity Exercise: using the Biodex 3 Dynamometer in isotonic mode at 10% (first 3 weeks), 15% (following 3 weeks) and 20% (final 3 weeks) of their 1RM for each side in each exercising limb without partial blood flow restriction.
16210594|NCT01311193|Other|light therapy|early morning exposures to bright light, 8000lux for 40min, daily during 3 weeks
16210595|NCT01311180|Drug|Sensoril®|Start with 250 mg po QAM for 7 days and then 250 mg po bid for 7 weeks
16210596|NCT01311180|Drug|Placebo|Start with 250 mg po QAM for 7 days and then 250 mg po bid for 7 weeks
16210597|NCT01311167|Drug|Dexamethasone|Daily administration of 2 mg of dexamethasone for 4 days
16210598|NCT01311167|Drug|Placebo|Daily administration of 2 mg of placebo for 4 days
16210599|NCT01311141|Drug|doripenem|doripenem once i.v.500mg
16210600|NCT01311128|Device|T-line hemodynamic monitoring device (placement and use)|The T-line device will be placed over the contralateral (from the radial artery catheter) radial artery at the distal wrist. To attach the device, a single-use sterile sensor is placed over the radial artery and the device then gently clamped around the wrist to incorporate the sensor. After a ten-minute stabilization period, data will be recorded every ten minutes during the first two hours of surgery, or until the patient is placed on cardiopulmonary bypass. The T-line device will then be removed. This procedure will be repeated, for a second two-hour period, in the ICU postoperatively.
16210601|NCT01311115|Behavioral|Group commitment contract|"Each participant is required to deposit at least 50 baht at enrollment. A deposit collector visits each participant on a weekly basis and collects additional deposits on a voluntary basis. All deposits are returned only if the smoker quits successfully within three months.
~The project gives a matching contribution of 150 baht for the initial deposit of at least 50 baht. All participants in the treatment group are further randomized to a one-month group and a three-month group. The one-month group receives an additional 150 baht of project funds if they deposit 100 baht of their money within one month of enrollment. The three-month group receives 150 baht for depositing 100 baht within three months of enrollment.
~Each participant is paired with another study participant. If both quit, each receives a cash bonus of 1,200 baht. At enrollment, pairs receive brief counseling on ways to support each other during the quit attempt."
16210602|NCT01311115|Behavioral|Smoking cessation education and counseling|Participants receive educational pamphlets on reasons to quit smoking and strategies for quitting smoking. They also receive one-time, group counseling on quitting smoking from a nurse trained in smoking cessation counseling.
16210603|NCT01311102|Drug|Lidocaine|1.33 cc 2% liquid lidocaine
16210604|NCT01311102|Drug|Normal Saline|1.33cc normal saline
16210605|NCT01311076|Drug|TAK-329|TAK-329 50 mg, tablets, orally, single dose, one day.
16210606|NCT01311076|Drug|TAK-329|TAK-329 200 mg, tablets, orally, single dose, one day.
16210607|NCT01311076|Drug|Insulin|Insulin 0.2 U/kg, subcutaneous injection, single dose, one day.
16210608|NCT01311076|Drug|Placebo|TAK-329 placebo-matching tablets, orally, single dose, one day.
16210609|NCT01311050|Drug|Capecitabine (Xeloda), Oxaliplatin, Irinotecan, Bevacizumab|Capecitabine (Xeloda), Oxaliplatin, Irinotecan, Bevacizumab
16210610|NCT01311037|Other|GnRh Analogue and Aromatase Inhibitor|GnRh Analogue and Aromatase Inhibitor
16210611|NCT01311024|Biological|PCV GSK1024850A|2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)
16210612|NCT01311024|Biological|hepatitis B vaccine or hepatitis A vaccine|2 to 4 doses administered to the siblings in the cluster-randomized Finnish Invasive pneumococcal Disease Trial (ClinicalTrials.gov Identifier:NCT00861380)
16210613|NCT01311011|Procedure|SCT|SCT
16210615|NCT01310985|Drug|Capecitabine (Xelodaâ), XRT & Cetuximab (Erbitux®)|Capecitabine (Xelodaâ), External Beam Radiation and Cetuximab (Erbitux®)
16210616|NCT01310972|Other|Registry|Registry
16210617|NCT01310959|Other|Database|Database
16210618|NCT01310946|Other|Database|Database
16210619|NCT01310920|Other|observation|genotyping
16210620|NCT01310894|Drug|TOOKAD® Soluble|TOOKAD® Soluble-VTP procedure will consist of an IntraVenous (IV) administration to patients using a 753nm laser light at a fixed power of 150mW/cm and a fixed energy at 200J/cm delivered through transperineal interstitial optical fibers. The needles are positioned in the prostate under ultra sound image guidance
16210621|NCT01310881|Drug|NSI-189 Phosphate|Once daily oral administration
16210622|NCT01310868|Drug|5-ALA|5-ALA is used to generate tumour specific fluorescence as an aid to surgical resection of GBM, prior to the insertion of Gliadel wafers
16210623|NCT01310868|Drug|Gliadel wafers|The implantation of Carmustine Wafers (Gliadel) delivers carmustine- (3-bis 2-chloroethyl 1-1-nitrosourea (BCNU)) directly into the surgical cavity created after tumour resection.
16210624|NCT01310868|Radiation|Radiotherapy as normal based on standard clinical protocols determined by the neuro-oncologist|60Gy in 30 fractions (2Gy per fraction given once daily, five days per week (Monday-Friday) over 6 weeks. Radiotherapy delivered to gross tumour volume with 2-3cm margin. Standard treatment following neurosurgery for glioblastoma
16210625|NCT01310868|Drug|Concomitant chemotherapy as normal based on standard clinical protocols determined by the neuro-oncologist|temozolomide given alongside the radiotherapy at 75mg/m2 daily from the first day of radiotherapy, until the last day of radiotherapy, but for no longer than 49 days. Standard treatment following neurosurgery for glioblastoma
16210626|NCT01310868|Drug|Adjuvant chemotherapy as normal based on standard clinical protocols determined by the neuro-oncologist|Following a 4 week break after contomitant chemo/RT, temozolomide given 150-200mg/m2 TMZ 5/28 days for 6 cycles (dosage increase to 200mg/m2 on second and subsequent cycles dependent on haematological toxicity. Sites should follow local guidelines if different.). TMZ to be given on 5 consecutive days followed by 23 days with no TMZ, per cycle. Standard treatment following neurosurgery and concomitant chemo/RT for glioblastoma
16210627|NCT01310855|Drug|cediranib maleate|
16210628|NCT01310855|Drug|gefitinib|
16210629|NCT01310855|Drug|Placebo|
16210630|NCT01310842|Behavioral|Questionnaires|Questionnaires completed at each study visit, taking 60-90 minutes, in addition to 4 Smart Phone initiated assessments per day during waking hours, taking about 5-10 minutes.
16210631|NCT01310842|Drug|Nicotine Patch Therapy|4 weeks of nicotine patch therapy
16210632|NCT01310842|Behavioral|Counseling Sessions|5 or 7 in person counseling sessions on smoking cessation: Baseline, Week 0/Quit Date (1 week following the baseline visit), Week 1, Week 2, Week 3 for Pilot Group and additional sessions Week 12 and Week 26 for other group.
16210633|NCT01310829|Behavioral|Questionnaires|Questionnaires completed before and after viewing virtual reality scenes, taking about 30 minutes to complete.
16210634|NCT01310829|Behavioral|Physiological Measurements|Small sensors applied to skin will measure heart rate and sweat amounts while participants view a virtual reality scene.
16210635|NCT01310829|Behavioral|Virtual Reality Scene Viewing|Prototype virtual reality application that demonstrates a provider-patient communication scenario commonly encountered in genetic counseling for hereditary cancers.
16210636|NCT01310816|Drug|IPI-926|Oral
16210637|NCT01310816|Drug|Placebo Arm|oral placebo
16210638|NCT01310803|Drug|VALSTAR - Maintenance Therapy|Treatment phase - 10 monthly intravesical installations starting 10 to 12 weeks after the beginning of induction. Follow-up phase
16210639|NCT01310803|Other|No Maintenance treatment ( Standard of Care)|Subjects randomized to No Maintenance (Standard of Care) will not receive any additional intravesical therapy
16210640|NCT01310790|Procedure|lactate group:lactate acide clearance directed group; ScvO2 group:ScvO2 directed group;control group|"Patients assigned to lactate group started with the resuscitation to achieve a CVP of 8 to 12 mmHg and MAP 65 to 90 mmHg. Then if ScvO2 was less than 70 percent, red cells were transfused to achieve a hematocrit of at least 30 percent. After the CVP, MAP, and hematocrit achieved the goals, dobutamine was given until the ScvO2 was 70 percent or higher. Arterial blood lactate concentration was obtained at 6 hours and try to achieve lactate clearance was >30%.
~Patients in the ScvO2 group received the treatment as ScvO2 directed therapy protocol for at least 6 hours and maintained for 72 hours. The protocol was the same as that of lactated directed therapy with the exception of blood lactate concentration testing.
~Patients in the control group received the treatment as the same protocol for maintaining CVP and MAP in that of lactated directed therapy. ScvO2 and arterial blood lactated concentration were not necessary to obtain."
16210641|NCT01310777|Drug|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension|
16210642|NCT01310777|Drug|Brinzolamide 1% ophthalmic suspension|
16210643|NCT01310777|Drug|Brimonidine tartrate 0.2% ophthalmic solution|
16210644|NCT01310764|Procedure|Trabeculectomy|Both groups underwent trabeculectomy ,but in active group bevacizumab was used and in sham group mitomycin c was used during the surgery.
16210645|NCT01310751|Drug|iloprost nebuliser solusion|50 ng/kg/min inhalation for 10 minutes, q2h for 2 days
16210646|NCT01310751|Drug|distilled water|2 ml per session
16210647|NCT01310738|Drug|Antimoniate of N-methylglucamine|Antimoniate of N-methyl glucamine 20mg/kg/d of pentavalent antimonial, I.V. for 20 consecutive days.
16210648|NCT01310738|Drug|amphotericin B deoxycholate|1mg/kg/d, I.V. for 14 consecutive days.
16210649|NCT01310738|Drug|Liposomal amphotericin B|3mg/kg/d, I.V. for 7 consecutive days.
16210650|NCT01310738|Drug|Liposomal amphotericin B|10mg/kg/d, I.V. single dose.
16210651|NCT01310738|Drug|Antimoniate of N-methylglucamine|20mg/kg/d of pentavalent antimonial I.V. for 10 days
16210652|NCT01310725|Procedure|Coronary artery bypass grafting|Bypass of stenoses in coronary arteries using different types os vessels as conduit.
16210653|NCT01310712|Drug|Oxybutynin|5 mg every 12 hours for 6 weeks
16210654|NCT01310712|Drug|placebo|placebo twice a day for 42 days.
16210655|NCT01310699|Device|Olympus Colonoscope CFHQ190AL|Technically improved colonoscope with close focus high definition narrow band imaging.
16210656|NCT01310673|Drug|Allopurinol|"Allopurinol 300mg po QD for 30 days.
~Indomethacin 50mg TID for 10 days. Colchicine 0.6mg po Bid or QD, as tolerated for 90 days."
16210657|NCT01310673|Drug|Placebo|"Placebo tablet QD for 10 days, followed by delayed allopurinol 300mg po QD days 11-30.
~Indomethacin 50mg TID for 10 days. Colchicine 0.6mg po Bid or QD, as tolerated for 90 days."
16210658|NCT01310647|Drug|Testosterone|Transdermal testosterone (20µg/kg/day)from day 24 of the previous cycle to day 2 of the ICSI cycle
16210659|NCT01310647|Drug|Estradiol|Transdermal estradiol (200µg/day)from day 20 of the previous cycle to day 3 of the ICSI cycle
16210660|NCT01310647|Drug|CombEq|"(150µg Desogestrel + 30µg Ethinylestradiol)/day during the luteal phase of the two cycles prior to the ICSI.
~Valerate estradiol 4mg/day during 10 days, starting the second day of the cycle prios to the ICSI cycle."
16210661|NCT01310634|Behavioral|Comprehensive intervention|Parents of hospitalized neonates received comprehensive intervention program,including parent educational-behavioral intervention program, effective doctor/nurse parent communication,regularly visit the neonatal ward and care the hospitalized neonates under the guidance of a doctor.
16210662|NCT01310621|Drug|Bovine surfactant|"Dose of diluted surfactant : 20ml/kg
~Type :Bovine surfactant
~Phospholipid concentration: 5 mg/ml
~Number of lavages to be given: 2 (10ml/kg each)"
16210663|NCT01310608|Other|A-View|Pre-operative imaging of the thoracic aorta with A-View technique
16210664|NCT01310595|Procedure|Manual mobilization on cervical spine|Manual mobilization provided on selected cervical spine in patients with chronic mechanical neck apin
16210665|NCT01310595|Procedure|Infra-red therapy with self exercise pamphlet|Infra-red radiation therapy on cervical spine with self exercise pamphlet given to patients with chronic mechanical neck pain.
16210666|NCT01310582|Drug|Desflurane|
16210667|NCT01310582|Drug|Sevoflurane|
16210668|NCT01310556|Other|ogtt for patients with coronary artery disease|75 g OGTT
16210669|NCT01310543|Behavioral|Teens and Toddlers|The T&T intervention aims to prevent teenage pregnancy and promote sexual health by providing young women at risk of teenage pregnancy with regular and direct contact with a toddler and combines this with 12 modules of group-based personal-development sessions involving communication skills, anger management, discussion of positive sexual health and relationships, culminating in an accredited National Award in Interpersonal Skills. One-to-one life coaching is also provided. The intervention consists of 20 weekly afternoon sessions run in nurseries near to the secondary schools from which participating young women are recruited.
16210670|NCT01310530|Radiation|Proton Beam Radiotherapy|Daily proton beam radiotherapy is delivered to the site of the breast tumor in ten treatment sessions over two week as an outpatient.
16210671|NCT01310504|Procedure|SonoSite Ultrasound|Will be moulaged to resemble a peritoneal dialysis patient. Paramedics will scan the abdomen and determine it there's fluid within.
16210672|NCT01310504|Procedure|SonoSite Ultrasound|Paramedics will scan the abdomen and determine it there's fluid within.
16210673|NCT01310491|Behavioral|Health coaching|Telephone based health coaching supported by tele-monitoring.
16210674|NCT01310478|Drug|recombinant human endostatin (Endostat)|mFOLFOX6:Oxaliplatin 85 mg/m2 d1 Leucovorin 400 mg/m2 d1+5-FU 400 mg/m2 bolus d1+5-FU 2.4 CIV 46h Endostar 7.5mg/m2/d～45mg/m2/d continous intravenous d4～d14
16210675|NCT01310465|Drug|zoledronic acid|zoledronic acid, 5mg(100ml), intravenous, one time at three days postoperatively
16210676|NCT01310465|Drug|sodium chloride|sodium chloride, 100ml, intravenous, one time at three days postoperatively
16210677|NCT01310452|Drug|insulin detemir|insulin detemir once daily with metformin
16210678|NCT01310452|Drug|neutral protamine insulin|neutral protamine insulin once daily with metformin
16210679|NCT01310426|Other|3D transperineal Ultrasound|3D transperineal Ultrasound after vaginal delivery
16210680|NCT01310413|Biological|Influenza A (H5N1) Virus monovalent vaccine|All subjects will receive 2 doses administered as an intramuscular (IM) injection.
16210681|NCT01310413|Biological|Saline placebo|All subjects will receive 2 doses administered as an intramuscular (IM) injection.
16210682|NCT01310400|Biological|Inflexal V|"Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose:
~15 µg hemagglutinin (HA) antigen of A/Brisbane/59/2007 (H1N1)-like virus
~15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus
~15 µg HA antigen of B/Brisbane/60/2008-like virus
~Dose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Days 0 and 28"
16210683|NCT01310400|Biological|Inflexal V|"Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose:
~15 µg HA antigen of A/Brisbane/59/2007 (H1N1)-like virus
~15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus
~15 µg HA antigen of B/Brisbane/60/2008-like virus
~Dose: intramuscular administration (M. deltoideus) of a single dose of 0.25 mL on Days 0 and 28"
16210684|NCT01310400|Biological|Agrippal|"Agrippal influenza vaccine
~Dose: intramuscular administration (M. deltoideus) of a single dose of 0.25 mL on Days 0 and 28"
16210685|NCT01310387|Behavioral|Active pain management|Active pain management will be provided by specialized pain nurse, such as telephone counseling for toxicity control and opioid dose modification.
16210686|NCT01310361|Drug|Amoxicillin|
16210687|NCT01310361|Drug|Intramuscular Benzathin Penicillin G|It is mentioned underlined in page 10 in research. (Once the throat swab was taken and cultured on plate at the place where the child was examined, hygiene teacher was trained about how to prepare the oral amoxicillin suspension and how to give it to the child. 750 milligrams of amoxicillin was thereafter given to the patient and in order not to infect other school children, the patient was sent home. The following morning, the patient would come to school and was given the second dose of amoxicillin by the hygiene teacher. All oral drugs were bought from a creditable company. In the injection group, 600000 units of penicillin was administered to children who weigh less than 27 kilograms and 1200000 units of penicillin was administered to children who weigh more. After 48 hours, patients were examined again when the result of first culture was ready)
16210688|NCT01310348|Device|whole-body vibration (WBV)|The whole-body vibration (WBV) training group will be trained on a WBV platform (Power Plate) 5 times a week for 4 weeks period. Training volume and training intensity will be low at the beginning but progressed slowly according to the overload principle. The training volume will be increased systematically over the 4-week training period. The training intensity will be increased by increasing the amplitude (2-4 mm) and the frequency (40 Hz) of the vibration.
16210689|NCT01310348|Device|WBV (Sham stimulation)|Sham stimulus will be performed by WBV platform 5 times a week for a 4 weeks period.
16210989|NCT01308138|Procedure|remote ischemic preconditioning|remote ischemic preconditioning
16210690|NCT01310335|Device|whole-body vibration (WBV)|All cases will be trained on a whole-body vibration (WBV) platform (Power Plate) 5 times a week for one week period.
16210691|NCT01310322|Drug|AZD5423|solution for injection, administered as intravenous infusion Corr to total dose of 250µg AZD5423
16210692|NCT01310322|Drug|AZD5423|nebuliser suspension, inhaled via Spira, corr to approximately 300 µg lung deposited dose AZD5423
16210693|NCT01310322|Drug|AZD5423|nebuliser suspension, inhaled via I-neb, corr to approximately 300 µg lung deposited dose AZD5423
16210694|NCT01310322|Drug|AZD5423|nebuliser suspension to be administered orally, corr to a total dose of 1200 µg AZD5423
16210695|NCT01310309|Device|Coronary artery placement of a drug-eluting stent|Coronary artery placement of a drug-eluting stent (XIENCE V® EECSS)
16210696|NCT01310296|Drug|Lofexidine hydrochloride|Single Dose = Solution containing 400 μg lofexidine HCl and a tracer amount of 14C lofexidine
16210697|NCT01310296|Drug|Lofexidine hydrochloride|Single Dose = 200 μg lofexidine in phosphate-buffered saline administered intravenously via infusion pump at a rate of 1 μg/min for 200 min
16210698|NCT01310283|Other|xylitol mints and fluoride varnish|Subjects in the intervention group will receive additional diet, oral hygiene handouts, more frequent professional fluoride application, and xylitol mints based on their caries risk levels.
16210699|NCT01310270|Dietary Supplement|Pro-Omega|Pro-Omega, 4.4gm/day x 1 month
16210700|NCT01310270|Dietary Supplement|Omega 3 Fatty Acid|4.4 gm/day for 1 month
16210701|NCT01310257|Other|Questionnaires|Patients will be given questionnaires relevant to their condition to complete. In Study 2 and a sub-study of Study 1, patients will be invited to take part in Quantitative Sensory Testing.
16210702|NCT01310244|Drug|Belinostat, Carboplatin, Paclitaxel|Up to 6 cycles of combination therapy of belinostat plus carboplatin (AUC 6) and paclitaxel 200 mg/m2. Initial dose of belinostat will be 1000mg/m2 for MTD dose escalation evaluation.
16210703|NCT01310231|Drug|Metformin|"metformin 850 mg bid in addition to standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).
~Number of cycles: Until progression or unacceptable toxicity develops."
16210704|NCT01310231|Drug|Placebo|"Placebo bid in addition to standard chemotherapy (containing anthracyclines, platinum, taxanes or capecitabine; first or second line).
~Number of cycles: until progression or unacceptable toxicity develops."
16210705|NCT01310218|Other|extended postoperative dressing|2 weeks of bulky dressing
16210706|NCT01310218|Other|short postoperative dressing|2 days bulky dressing followed by bandaid
16210707|NCT01310205|Drug|SCV-07|This is an extension of ongoing study SCI-SCV-HCV-P2-001. Subjects will be invited to participate in this extension study if they complete treatment in study SCI-SCV-HCV-P2-001 and are eligible for retreatment with peg-IFN and RBV
16210708|NCT01310192|Device|Fluourine-18 Fluoromethylcholine PET/CT Imaging|Single-dose Study
16210709|NCT01310179|Genetic|Ad/PNP and fludarabine monophosphate|Subjects in the first 3 cohorts will receive 3x10e11 VP for 3 injections and escalating dose levels of F-araAMP (15, 45, and 75 mg/m2 in each sequential cohort) daily for 3 days. The fourth cohort will receive 3x10e12 for 3 injections and 75 mg/m2 fludarabine daily for 3 days.
16210710|NCT01310166|Drug|Fingolimod|
16210711|NCT01310153|Procedure|prone positioning|newborn babies in prone positioning
16210712|NCT01310153|Procedure|Supine|newborn babies in supine positioning
16210713|NCT01310127|Drug|Bromfenac|bromfenac 0.9% QD starting 3 days prior to cataract surgery, on the day of surgery and for up to 45 days after surgery
16210714|NCT01310127|Drug|Nepafenac|nepafenac ophthalmic suspension 0.1% TID dosed 3 days prior to cataract surgery, on the day of surgery, and for up to 45 days after surgery
16210715|NCT01310114|Biological|Human Placenta-Derived Cells PDA001- (cenplacel-L)|240 mL of intravenous infusion
16210716|NCT01310114|Drug|Placebo|Thawed placebo
16210717|NCT01310101|Drug|ofatumumab plus dexamethasone|"Dose and schedule
~Cycle 1:
~Ofatumumab: 300 mg as an i.v. infusion on day 1 of the cycle; Ofatumumab: 2000 mg as an i.v. infusion on days 8, 15, 22; Dexamethasone: 40 mg/day p.o., days 1-4 and 15-18
~Cycles 2 to 6 (cycles every 28 days):
~Ofatumumab: 1000 mg i.v. infusion on day 1, 8, 15 and 22 of the cycle; Dexamethasone: 40 mg/day p.o., days 1-4 and 15-18"
16210718|NCT01310088|Behavioral|Lifestyle intervention|Treatment protocol. The Children's Obesity Clinic Department of Paediatrics Holbaek Hospital, University of Copenhagen Denmark
16210719|NCT01310075|Device|Alloderm|6 x 12 cm piece or 6 x 16 cm piece is trimmed into a semicircle and sewn into the inframammary fold using vicryl. The smooth side is placed against the implant.
16210720|NCT01310075|Device|Surgimend|10 x 15 cm piece of fenestrated material is sewn to the fold, curved side along the fold, using vicryl suture.
16210721|NCT01310049|Drug|LEO 32731|"Part 1 and 2: Oral single dose of oral solution or capsule
~Part 3: Twice daily dose of oral solution or capsule for 7 days"
16210722|NCT01310036|Drug|Erlotinib|Erlotinib 150 mg was administered orally daily until disease progression or unacceptable toxicity.
16210723|NCT01310010|Drug|dasatinib|Treatment with 100 mg QD of dasatinib (Sprycel®) administered orally as continuous daily dosing (CDD).
16210724|NCT01309997|Drug|imatinib mesylate|Given PO
16210725|NCT01309997|Biological|rituximab|Given IV
16210726|NCT01309984|Drug|Lusedra|Pretreatment Phase - approximately 3 hours (Baseline) • Treatment Phase - approximately 8 days (includes Treatment, Discharge [up to 24 hours], and Follow-up Telephone Call on Day 8 post-dose after Discharge)
16210727|NCT01309984|Drug|Propofol|Pretreatment Phase - approximately 3 hours (Baseline) • Treatment Phase - approximately 8 days (includes Treatment, Discharge [up to 24 hours], and Follow-up Telephone Call on Day 8 post-dose after Discharge)
16210728|NCT01309945|Drug|Duloxetine|Capsule, Oral, 30-60 mg/day, once daily (QD), 8 weeks
16210729|NCT01309945|Drug|Placebo matching with BMS-820836|Tablet, Oral, 0.0 mg, once daily (QD), 14 weeks
16210730|NCT01309945|Drug|BMS-820836|Tablet, Oral, 0.5-2.0 mg, once daily (QD), 6 weeks
16210731|NCT01309945|Drug|Duloxetine|Capsule, Oral, 30-60 mg/day, once daily (QD), 6 weeks
16210732|NCT01309945|Drug|Placebo matching with Duloxetine|Tablet, Oral, 0.0 mg, once daily (QD), 8 weeks
16210733|NCT01309932|Biological|Pegylated Interferon Lambda (pegIFNλ)|Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 or 48 weeks depending on response
16210734|NCT01309932|Drug|BMS-790052 (NS5A Inhibitor)|Tablets, Oral, 60 mg, Once daily, 24 weeks
16211052|NCT01307631|Other|Laboratory Biomarker Analysis|Correlative studies
16210735|NCT01309932|Drug|Ribavirin (RBV)|Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 48 weeks
16210736|NCT01309932|Drug|BMS-650032 (NS3 Protease Inhibitor)|Tablets, Oral, 200 mg, Twice daily, 24 weeks
16210737|NCT01309932|Biological|Pegylated Interferon Alfa-2a (pegIFNα-2a)|Solution, Subcutaneous, 180 μg/mL, Once weekly, 48 weeks
16210738|NCT01309932|Biological|Pegylated Interferon Lambda (pegIFNλ)|Solution, Subcutaneous, 180 μg/mL, Once weekly, 24 weeks
16210739|NCT01309932|Drug|Ribavirin (RBV)|Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 24 weeks
16210740|NCT01309932|Biological|Pegylated Interferon Lambda (pegIFNλ)|Solution, Subcutaneous, 180 μg/mL, Once weekly, 16 weeks
16210741|NCT01309932|Drug|Ribavirin (RBV)|Tablets, Oral, 1000 or 1200 mg based on weight, Twice daily, 16 weeks
16210742|NCT01309932|Drug|BMS-790052 (NS5A Inhibitor)|Tablets, Oral, 60 mg, Once daily, 16 weeks
16210743|NCT01309932|Drug|BMS-650032 (NS3 Protease Inhibitor)|Tablets, Oral, 200 mg, Twice daily, 16 weeks
16210744|NCT01309932|Drug|Placebo (PBO) for BMS-650032 (Placebo for NS3 Protease Inhibitor)|Tablets, Oral, 0 mg, Twice daily, 24 weeks
16210745|NCT01309932|Drug|Placebo (PBO) for BMS-790052 (Placebo for NS5A Inhibitor)|Tablets, Oral, 0 mg, Once daily, 24 weeks
16210746|NCT01309932|Drug|Placebo for Ribavirin (RBV)|Tablets, Oral, 0 mg, Twice daily, 24 weeks
16210747|NCT01309932|Drug|Placebo for Ribavirin (RBV)|Tablets, Oral, 0 mg, Twice daily, 16 weeks
16210748|NCT01309919|Device|IUD|Placement of the IUD after delivery (vaginal or cesarean birth), either immediately (within 10 minutes of placental delivery) or delayed (within 48 hours of delivery). Subjects will also keep a bleeding diary for three months postpartum.
16210749|NCT01309919|Other|Diary|Subjects will keep a bleeding diary for three months
16210750|NCT01309906|Device|Investigational lens|Bausch & Lomb investigational silicone hydrogel contact lens worn on a daily wear basis for 1 week.
16210751|NCT01309906|Device|Air Optix Aqua lens|Ciba Visions Air Optix Aqua contact lens, worn on a daily wear basis for 1 week.
16210752|NCT01309893|Device|Investigational Lens|Lenses worn on a daily wear basis for one week
16210753|NCT01309893|Device|Air Optix Aqua lens|Lenses worn on a daily wear basis for one week
16210754|NCT01309880|Device|Test lens|Investigational silicone hydrogel contact lens worn on a daily wear basis
16210755|NCT01309880|Device|Air Optix Aqua|Air Optix Aqua contact lens worn on a daily wear basis
16210756|NCT01309867|Device|Investigational Toric Lens|Bausch & Lomb investigational toric contact lens worn on a daily wear basis for 2 weeks.
16210757|NCT01309867|Device|PureVision Toric Lens|Currently marked Bausch & Lomb PureVision Toric Lens worn on a daily wear basis for 2 weeks.
16210758|NCT01309854|Drug|fostamatinib|oral tablets, 100mg (2 X 50mg) twice daily for 8 days
16210759|NCT01309854|Drug|pioglitazone|oral tablets, 30mg single dose per period
16210760|NCT01309841|Drug|NKTR-118|12.5 mg oral tablet once daily
16210761|NCT01309841|Drug|NKTR-118|25 mg oral tablet once daily
16210762|NCT01309841|Drug|Placebo|Oral tablet once daily
16210763|NCT01309828|Drug|Azilsartan medoxomil and chlorthalidone|Fixed-dose combination tablets.
16210764|NCT01309828|Drug|Olmesartan medoxomil and hydrochlorothiazide|Fixed-dose combination tablets.
16210765|NCT01309802|Drug|onabotulinum toxin type-A|up to 4 injections per hand dosage per injection: 100 units diluted in 2.0 mL normal saline; dosing will not exceed 360 units in a 3 month interval frequency: no less than 28 days between injections duration: during Study Year 1
16210766|NCT01309789|Drug|brentuximab vedotin|1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-2 and if response, Cycles 9-16)
16210767|NCT01309789|Drug|cyclophosphamide|750 mg/m2 IV every 3 weeks (Cycles 3-8)
16210768|NCT01309789|Drug|brentuximab vedotin|1.2-1.8 mg/kg IV every 3 weeks (Cycles 1-6 and if response, Cycles 7-16)
16210769|NCT01309789|Drug|prednisone|100 mg daily PO on Days 1-5 every 3 weeks (Cycles 3-8)
16210770|NCT01309789|Drug|cyclophosphamide|750 mg/m2 IV every 3 weeks (Cycles 1-6)
16210771|NCT01309789|Drug|doxorubicin|50 mg/m2 IV every 3 weeks (Cycles 3-8)
16210772|NCT01309789|Drug|doxorubicin|50 mg/m2 IV every 3 weeks (Cycles 1-6)
16210773|NCT01309789|Drug|prednisone|100 mg daily PO on Days 1-5 every 3 weeks (Cycles 1-6)
16210774|NCT01309789|Drug|vincristine|1.4 mg/m2 IV every 3 weeks (Cycles 3-8)
16210775|NCT01309776|Drug|Tianeptine|week1 : 25mg/day q.d., week2: 37.5mg/day b.i.d. (12.5mg 1T, 12.5mg 2T
16210776|NCT01309776|Drug|Escitalopram|week1 : 5mg/day q.d., week2: 10mg/day q.d.
16210777|NCT01309763|Biological|AFFITOPE AD03|s.c. injection
16210778|NCT01309763|Biological|AFFITOPE AD03 + Alum|s.c. injection
16210779|NCT01309750|Radiation|Small Bowel Transit Study|Patients that are enrolled and consented in the study will be given 300ml of water containing 5 millicurie (mCi) of technetium-99m (Tc-99m) diethylenetriamine pentaacetate (DTPA). This nuclear tracer/water mix will either be drank orally or placed down a nasogastric tube to begin the study. The patient will have to have nothing else to eat or drink for the duration of the study. The patients will have a nuclear scan performed at 2, 4, and 6 hours after ingestion of the nuclear tracer.
16210780|NCT01309737|Drug|CP-690,550|10 mg oral BID, Continuous treatment for 52 Weeks
16210781|NCT01309737|Drug|CP-690,550|5 mg oral BID, Continuous treatment for 52 Weeks
16210782|NCT01309737|Drug|Placebo/CP-690,550|0 mg oral BID, Continuous Treatment for 16 Weeks; 10 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)
16210783|NCT01309737|Drug|Placebo/CP-690,550|0 mg oral BID, Continuous Treatment for 16 Weeks; 5 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)
16210784|NCT01309724|Other|USCOM-guided fluid administration|Patients in the intervention group underwent hemodynamic measurements with the ultrasound cardiac output monitor. Based on these measurements, patients were guided through a fluid resuscitation protocol.
16210785|NCT01309698|Drug|Vildagliptin (LAF237)|
16210786|NCT01309698|Drug|Voglibose|
16210787|NCT01309698|Drug|Vildagliptin and Voglibose|
16210788|NCT01309685|Drug|Varenicline|
16210789|NCT01309672|Drug|abiraterone acetate|1,000 mg, oral (on an empty stomach at least 2 hours after or 1 hour before eating); taken daily
16210790|NCT01309672|Drug|Prednisone|5 mg, oral, 5 mg twice daily
16211053|NCT01307618|Biological|NA17.A2 Peptide Vaccine|Given SC or ID
16210791|NCT01309659|Drug|iron sucrose|Patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter.
16210792|NCT01309659|Drug|iron sucrose|Following 12 weeks of observation patients will receive intravenous iron sucrose preparation at a dose of 200 mg per week through a peripheral intravenous catheter.
16210793|NCT01309646|Biological|Infanrix™-IPV+Hib|Intramuscular, 3 doses
16210794|NCT01309646|Biological|Infanrix™ IPV|Intramuscular, 3 doses
16210795|NCT01309646|Biological|Hiberix™|Intramuscular, 3 doses
16210796|NCT01309646|Biological|Synflorix™|Intramuscular, 3 doses
16210797|NCT01309646|Biological|Rotarix™|Oral, 2 doses
16210798|NCT01309633|Drug|12.5mg sunitinib with Cisplatin and Gemcitabine|"1) Arm A
~Day -6 to Day 0 (total 7 days):
~Sunitinib 12.5mg daily Cycles 1 and 2 - Day 1: IV Gemcitabine 1000mg/m2 + IV Cisplatin 75mg/m2 Day 8: IV Gemcitabine 1000mg/m2 Day 15 to Day 21: Sunitinib 12.5mg daily Cycle 3 - Day 1: IV Gemcitabine 1000mg/m2 + IV Cisplatin 75mg/m2 Day 8: IV Gemcitabine 1000mg/m2"
16210799|NCT01309633|Drug|25mg Sunitinib alternating with Cisplatin and Gemcitabine|"Arm B
~Day -6 to Day 0 (total 7 days):
~Sunitinib 25mg daily Cycles 1 and 2 - Day 1: IV Gemcitabine 1000mg/m2 + IV Cisplatin 75mg/m2 Day 8: IV Gemcitabine 1000mg/m2 Day 15 to Day 21: Sunitinib 25mg daily Cycle 3 - Day 1: IV Gemcitabine 1000mg/m2 + IV Cisplatin 75mg/m2 Day 8: IV Gemcitabine 1000mg/m2"
16210800|NCT01309633|Drug|7.5mg/kg Bevacizumab alternating with Cisplatin and Gemcitabine|Day -7: IV bevacizumab 7.5mg/kg diluted in normal saline over 30 minutes Day 1: IV Gemcitabine 1000mg/m2 + IV Cisplatin 75mg/m2 Day 8: IV Gemcitabine 1000mg/m2 For locally advanced patients, 3 cycles of treatment will be administered. For metastatic patients, up to 6 cycles would be administered.
16210801|NCT01309633|Drug|2.5mg/kg Bevacizumab alternating with Cisplatin and Gemcitabine|Day -7: IV bevacizumab 2.5mg/kg diluted in normal saline over 30 minutes Day 1: IV Gemcitabine 1000mg/m2 + IV Cisplatin 75mg/m2 Day 8: IV Gemcitabine 1000mg/m2 For locally advanced patients, 3 cycles of treatment will be administered. For metastatic patients, up to 6 cycles would be administered
16210802|NCT01309620|Dietary Supplement|Zinc gluconate|Zinc gluconate (GNC, USA), 100 mg twice daily
16210803|NCT01309620|Dietary Supplement|Placebo|Placebo, Twice Daily
16210804|NCT01309607|Drug|paclitaxel/carboplatin/lapatinib|"Drug doses for the neoadjuvant regimen:
~Paclitaxel 80mg/m2, day 1, 8, 15 of a 21-day cycle
~Carboplatin AUC of 2, day 1, 8 of a 21-day cycle
~Lapatinib 750mg daily continuously"
16210805|NCT01309594|Procedure|Hematopoietic stem cell transplantation|Harvest and apheresis of bone marrow cells from HIV infected patients with cirrhosis under general anesthesia, using bone marrow collection system and transplanting the patients' hematopoietic stem cells back to the patients
16210806|NCT01309581|Drug|Ketamine|Ketamine 1-2 mg/kg IV as indicated for ECT
16210807|NCT01309581|Drug|Methohexital|Methohexital 1 mg/kg IV as indicated for ECT
16210808|NCT01309555|Device|easypod™|Saizen (Somatropin) as per Summary of Product Characteristics administered by easypod™
16210809|NCT01309542|Drug|Desvenlafaxine Succinate|Tablet were taken at a daily dose of 200 to 400 mg/day for a duration up to 10 months
16210810|NCT01309516|Behavioral|Complex Intervention|This 12 session Multimodal Psychosocial Intervention will include a supportive component, an educational component, psychosocial component and a parenting programme.
16210811|NCT01309490|Drug|Ribavirin|Dose Level: 1 1400 mg po BID Dose Level: 2 1800 mg po BID Dose Level: 3 2200 mg po BID Dose Level: 4 2600 mg po BID Dose Level: 5 3000 mg po BID
16210812|NCT01309477|Drug|Tacrolimus Sustained-release Capsules (ADVAGRAF)|Started: 0.05-0.1mg/kg/d, one time per day, then adjusting the dose to maintain the blood level 5-10ng/ml in the induction treatment .
16210813|NCT01309451|Drug|Bevacizumab|intravitreal, 1.25mg., monthly
16210814|NCT01309451|Drug|dexamethasone intravitreal implant|0.7mg, intravitreal every 4 months
16210815|NCT01309438|Drug|Rivaroxaban (normal renal function)|One 10 mg tablet of rivaroxaban taken orally (by mouth) on Day 1 of Treatment Period 1; One 10 mg tablet of rivaroxaban taken orally on Day 5 of Treatment Period 2
16210816|NCT01309438|Drug|Rivaroxaban (mild and moderate renal impairment)|One 10 mg tablet of rivaroxaban taken orally (by mouth) on Day 1 of Treatment Period 1; One 5 mg tablet of rivaroxaban taken orally on Day 5 of Treatment Period 2; One 10 mg tablet of rivaroxaban taken orally on Day 5 of Treatment Period 3
16210817|NCT01309438|Drug|Erythromycin (normal renal function)|One 500 mg tablet taken orally (by mouth) three times daily on Days 1 to 6 of Treatment Period 2
16210818|NCT01309438|Drug|Erythromycin (mild and moderate renal function)|One 500 mg tablet taken orally (by mouth) three times daily on Days 1 to 6 of Treatment Periods 2 and 3
16210819|NCT01309425|Drug|tapentadol (CG5503) ER two 100-mg TRF|200mg TRF single oral dose
16210820|NCT01309425|Drug|tapentadol (CG5503) ER 50-mg TRF|50mg TRF single oral dose
16210821|NCT01309425|Drug|tapentadol (CG5503) ER 25-mg TRF|25mg TRF single oral dose
16210822|NCT01309425|Drug|tapentadol (CG5503) ER 100-mg TRF|100mg TRF single oral dose
16210823|NCT01309412|Drug|Siltuximab|5.5 or 11.0 mg/kg by intravenous infusion over 1 hour on Day 1 of each 21-day cycle until progression
16210824|NCT01309399|Drug|Teriparatide|six weeks of teriparatide
16210825|NCT01309399|Other|placebo|placebo
16210826|NCT01309386|Drug|Tapentadol ER|Tapentadol ER 100 to 400 milligram (mg) orally daily for 8 weeks (maximum up to 500 mg daily), as per Investigator's discretion.
16210827|NCT01309386|Drug|Morphine SR|Morphine SR 30 to 120 mg orally daily for 8 weeks (maximum up to 140 mg daily), as per Investigator's discretion.
16210828|NCT01309373|Other|Patient assessment|2 scales will be used to assesss the remission of schizophrenia (APA scale and PSRS scale). The BPRS scale will be used to assess the clinical integration of patients.
16210829|NCT01309360|Drug|midazolam|Prior to performing the regional anesthesia the investigators administered midazolam as a premedication by mouth (3,75-7,5mg) or intravenously (2-3mg).
16210830|NCT01309360|Drug|prilocaine 1%|40 outpatients : 40ml prilocaine 1% were administered for axillary plexus block
16210831|NCT01309360|Drug|prilocaine 1%|40 outpatients : 30ml prilocaine 1% were administered for axillary plexus block
16210832|NCT01309360|Drug|prilocaine 1%|40 outpatients : 20ml prilocaine 1% were administered for axillary plexus block
16210833|NCT01309334|Procedure|PET scan|Performed at diagnosis, after 3 cycles of induction therapy, and at completion of therapy
16211054|NCT01307618|Biological|Recombinant MAGE-3.1 Antigen|Given SC or ID
16210834|NCT01309334|Procedure|MRI|Performed at diagnosis, after 3 cycles of induction therapy, and at completion of therapy
16210835|NCT01309321|Behavioral|Perinatal Handwashing Promotion|Pregnancy may serve as a unique opportunity to improve maternal handwashing behavior more deeply and sustainably than a handwashing promotion intervention at a different time. Primiparous women will receive an intensive handwashing promotion program delivered at 3 in-home visits between one month prenatal and 1 week post natal. The program will promote handwashing benefits, provide hardware to reduce barriers to handwashing, and educate mothers about the critical times for handwashing. Mothers will also receive an essential neonatal care package with information on clean delivery, hypothermia prevention, breastfeeding counseling, umbilical cord care, and identification of neonatal danger signs.
16210836|NCT01309321|Behavioral|Neonatal Health Promotion|Mothers will receive an essential neonatal care package with information on clean delivery, hypothermia prevention, breastfeeding counseling, umbilical cord care, and identification of neonatal danger signs.
16210837|NCT01309308|Procedure|sweeping the membranes|The cervical length will be measured and the patient will be examined to determine the Bishop score. Later the the membranes will be swept.
16210838|NCT01309308|Other|No sweeping group|Cervical length will be measured by transvaginal USG and the patient will be examined to determine the Bishop score.
16210839|NCT01309243|Drug|FTC/RPV/TDF|Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (TDF) 300 mg single-tablet regimen administered orally once daily with a meal
16210840|NCT01309243|Drug|EFV/FTC/TDF|Efavirenz (EFV) 600 mg/FTC 200 mg/TDF 300 mg single-tablet regimen administered orally once daily on an empty stomach, preferably at bedtime
16210842|NCT01309217|Behavioral|Tobacco Tactics Intervention|"At the intervention sites the research nurse will teach the Tobacco Tactics Intervention to nurses. For nurses, the Cessation Toolkit includes: 1) 1 CEU contact hour for training; 2) PowerPoint presentation on behavioral and pharmaceutical interventions; 3) pocket card Helping Smokers Quit: A Guide for Clinicians developed by U.S. Department of Health and Human Services, Public Health Service; 4) behavioral and pharmaceutical protocols; and 5) computerized template for nurse documentation. For patients, the Cessation Toolkit includes: 1) brochure; 2) videotape; 3); and 4) pharmaceuticals."
16210843|NCT01309217|Other|Usual Care|The comparison group will receive usual care in accordance to how the hospital responds to current Joint Commission on Accreditation of Healthcare Organization's (JC) standards. JC standards require that a patient with a smoking history receives at least one of the following: advice to stop smoking, brochures or handouts on smoking cessation, a smoking cessation aid such as nicotine patch, gum, nasal spray, inhaler, lozenge, or bupropion SR, viewed a smoking cessation video.
16210844|NCT01309204|Drug|Brinzolamide 1%/brimonidine tartrate 0.2% fixed combination ophthalmic suspension|
16210845|NCT01309204|Drug|Vehicle|Inactive ingredients used as a placebo for masking purposes
16210846|NCT01309204|Drug|Brinzolamide 1% ophthalmic suspension|
16210847|NCT01309204|Drug|Brimonidine tartrate 0.2% ophthalmic solution|
16210848|NCT01309191|Drug|Minoxidil|Over the counter Rogaine, twice a day for 8 weeks
16210849|NCT01309191|Other|Placebo|
16210850|NCT01309178|Drug|Amitriptyline|2 x 12,5 mg capsules for oral use in the first two weeks, the higher dose of 50 mg (2 x 25 mg) will be adapted after 2 weeks of treatment.
16210851|NCT01309178|Drug|Mannite|Mannit capsules daily in two doses (2 x 12,5 mg). After 2 weeks of treatment the higher dose of 50 mg (2 x 25 mg) will be given
16210852|NCT01309165|Behavioral|CO-OP|CO-OP, a client-centred, performance-based, problem solving approach has 7 key features including: client-chosen goals, dynamic performance analysis, cognitive strategy use, guided discovery, and a specific 10-session intervention format. The client and the therapist work together, using the Canadian Occupational Performance Measure (COPM), to select 3 skills and establish baseline skill performance. In the second meeting, when CO-OP actually begins, the approach is introduced to the client and the global cognitive strategy (GOAL-PLAN-DO-CHECK) is learned. In all subsequent sessions this strategy is used as the main problem-solving framework to facilitate skill acquisition.
16210853|NCT01309165|Behavioral|Standard Occupational Therapy|Participants randomized to the SOT group will receive usual out-patient rehabilitation services, with slight modifications. Specifically, a research assistant will administer the COPM to assist participants to self-select 4 personally meaningful skills. The treating SOT occupational therapists will be asked to log the activities completed in each session, and the amount of time spent in therapy.
16210854|NCT01309139|Drug|Tiotropium|Medium dose of oral inhalation
16210855|NCT01309139|Drug|Tiotropium|Medium dose of oral inhalation
16210856|NCT01309139|Drug|BI 54903|Medium dose of oral inhalation
16210857|NCT01309139|Drug|BI 54903|Medium dose of oral inhalation
16210858|NCT01309126|Biological|Imprime PGG + cetuximab|Imprime PGG: 4 mg/kg and will be administered weekly in each cycle (Weeks 1-6/Days 1, 8, 15, 22, 29, and 36) preceding the administration of cetuximab Cetuximab: initial dose will be 400 mg/m2 on Cycle 1/Day 1 and subsequent doses will be 250 mg/m2, administered weekly in each cycle (Weeks 1-6/Days 1, 8, 15, 22, 29, and 36)
16210859|NCT01309126|Drug|Cetuximab|Cetuximab: initial dose will be 400 mg/m2 on Cycle 1/Day 1 and subsequent doses will be 250 mg/m2, administered weekly in each cycle (Weeks 1-6/Days 1, 8, 15, 22, 29, and 36)
16210860|NCT01309113|Drug|VAC BNO 1095 film coated tablets|3 dosages: Placebo, 10 mg of VAC BNO 1095 once daily in the morning, 10 mg of VAC BNO 1095 twice daily in the morning and in the evening
16210861|NCT01309100|Device|Investigational Lens|Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week.
16210862|NCT01309100|Device|Acuvue Oasys Lens|Johnson & Johnson Acuvue Oasys contact lens on a daily wear basis for 1 week.
16210863|NCT01309100|Device|Air Optix Aqua Lens|Ciba Vision Air Optix Aqua contact lens on a daily wear basis for 1 week.
16210864|NCT01309074|Drug|Pregabalin-Lyrica|Pregabalin in a dose up to 300mg/day in BID dosing.
16210865|NCT01309074|Drug|Sertraline|Sertraline in a dose up to 200mg/day in BID dosing.
16210866|NCT01309061|Procedure|Autologous Adipose Tissue derived MSCs Transplantation|Intramuscular infusion of Autologous Adipose Tissue derived MSCs with autologous microlipoinjection. Dose: 1x10e7 cells/500ul/lipoinjection 20ml
16210952|NCT01308463|Device|Discovery elbow minimally constrained|patient participating in the Discovery Elbow Multi-center study
16210867|NCT01309048|Device|Philips MR-guided HIFU system|HIFU is the use of focused ultrasound energy to penetrate through soft tissue and causes localized high temperatures (55°C to 70°C) for a few seconds within the target producing well defined regions of protein and nerve denaturation, irreversible cell damage, and coagulative necrosis.
16210868|NCT01309035|Procedure|Total Knee Arthroplasty|Surgery for OA knee pains
16210869|NCT01309022|Drug|Sirolimus|Obtained by prescription and given at doses used in ClinicalTrials.gov record NCT00014911.
16210870|NCT01309022|Drug|Tacrolimus|Obtained by prescription and given at doses used in ClinicalTrials.gov record NCT00014911.
16210871|NCT01309022|Drug|Mycophenolate mofetil|Obtained by prescription and given at doses used in ClinicalTrials.gov record NCT00014911.
16210872|NCT01309022|Drug|Mycophenolic acid|Obtained by prescription and given at doses used in ClinicalTrials.gov record NCT00014911.
16210873|NCT01309009|Drug|Nepadutant oral solution|Oral administration once daily for 7 days
16210874|NCT01309009|Drug|Placebo matching Nepadutant oral solution|Oral administration once daily for 7 days
16210875|NCT01309009|Drug|Nepadutant oral solution|Oral administration once daily for 7 days
16210876|NCT01308996|Device|INFUSE® Bone Graft|Implantation of INFUSE® Bone Graft [recombinant human Bone Morphogenetic Protein-2 (rhBMP-2)] and absorbable collagen sponge (ACS) carrier at 1.50 mg/cc with space maintenance device
16210877|NCT01308996|Procedure|Autogenous bone graft from tibia or iliac crest|Implantation of autogenous bone graft from iliac crest or tibia with titanium mesh space maintenance device
16210878|NCT01308983|Drug|Amiloride|Amiloride 10 mg orally once a day for 16 weeks
16210879|NCT01308970|Behavioral|Stress Management Group 1|Subjects will attend individual stress management sessions once weekly for 8 weeks and will be instructed to listen to a health education CD for 20 minutes every day for the duration of the study.
16210880|NCT01308970|Behavioral|Stress Management Group 2|Subjects will attend individual stress management sessions once weekly for 8 weeks and will be instructed to listen to a health education CD for 20 minutes every day for the duration of the study.
16210881|NCT01308970|Behavioral|Stress Management Group 3|Subjects will attend individual stress management sessions once weekly for 8 weeks and will be instructed to listen to a health education CD for 20 minutes every day for the duration of the study.
16210882|NCT01308957|Dietary Supplement|Omega-3 fatty acids|4 grams per day for 24 weeks
16210883|NCT01308957|Dietary Supplement|corn oil|4 grams per day for 24 weeks
16210884|NCT01308944|Drug|Propranolol|
16210885|NCT01308905|Device|FLT-PET|PET scan will be conducted at diagnosis, at the end of the first cycle of treatment and prior to the surgical procedure (resection).
16210886|NCT01308892|Dietary Supplement|High flavanol chocolate|chocolate high in flavanols
16210887|NCT01308892|Dietary Supplement|Low flavanol chocolate|chocolate low in flavanols
16210888|NCT01308892|Dietary Supplement|High fat challenge|Milkshake with 95g fat
16210889|NCT01308879|Behavioral|Contextualized Feedback Systems (CFS)tm|After clinical questionnaires are entered, an automated feedback report is available online weekly to clinicians (and supervisors) in the experimental group. The report shows current mental health status of youths, alerts, and trends over time. Reports also show some clinical data on youths' caregivers.
16210890|NCT01308866|Behavioral|Share decision tool|
16210891|NCT01308853|Device|Macrolane|Device: Macrolane Treatment: Initial injection (incl touch-up) of a maximum of 120 ml/breast.
16210892|NCT01308840|Drug|Panitumumab|Day 1 and 15 = 6 mg/kg IV
16210893|NCT01308840|Drug|oxaliplatin|Days 1 and 15 = 85mg/m2 IV
16210894|NCT01308840|Drug|gemcitabine|Days 1 and 15 = 1000 mg/m2 IV
16210895|NCT01308827|Procedure|Blood culture|A baseline blood culture will be obtained in all participants
16210896|NCT01308827|Procedure|Other cultures per Clinical routine practice|Cultures from other sterile sites will be obtained per routine clinical practice
16210897|NCT01308814|Drug|Estradiol|Transdermal 17β-estradiol (100 ug/day) for 12 months, administered as patches to be worn continuously and replaced once a week. Also, every 2 months, oral micronized progesterone (200 mg/day x 12 days) will be administered.
16210898|NCT01308814|Drug|Placebo|Placebo patches for 12 months, to be worn continuously and replaced once a week. Also, placebo pills will be administered for 12 days every 2 months.
16210899|NCT01308801|Device|active rTMS + rehabilitation exercise|14 weeks program of active repetitive transcranial magnetic stimulation associated with rehabilitation exercise
16210900|NCT01308801|Device|placebo rTMS+ rehabilitation exercise|14 week program of placebo repetitive transcranial magnetic stimulation associated with rehabilitation exercise
16210901|NCT01308775|Behavioral|SIS.NET, Routine Follow-up|"SIS.NET - One or two oncology related clinic visits per year (as recommended by the American Society of Clinical Oncology breast cancer follow up guidelines (18)), with additional access to oncology care driven by ongoing review of patient's self reported symptoms through web-based questionnaires.
~Routine follow up care with appointment frequency determined by the treating medical oncologist or oncology/breast surgeon. Patients complete the same web-based symptom questionnaires within 30 days of a scheduled clinic visit but the results are not reviewed until their clinic visit."
16210902|NCT01308762|Biological|Heat killed whole cell M. obuense (IMM-101) 0.1 mg|"Each patient will receive an intradermal placebo injection of borate buffered saline solution (day -3) to provide an intra patient placebo control. Patients who were willing and able to proceed with the study will receive an intradermal injection of a single dose level of IMM 101 on three subsequent occasions. Doses of IMM 101 were administered over a 4 week period on days 0, 14 and 28.
~Dose levels to be administered are 0.1 mg, 0.5 mg and 1.0 mg."
16210903|NCT01308762|Biological|Heat-killed whole cell M.obuense (IMM-101) 0.5 mg|Each patient will receive an intradermal placebo injection of borate buffered saline solution (day -3) to provide an intra patient placebo control. Patients who were willing and able to proceed with the study will receive an intradermal injection of a single dose level of IMM 101 on three subsequent occasions. Doses of IMM 101 were administered over a 4 week period on days 0, 14 and 28.
16210904|NCT01308762|Biological|Heat killed whole cell M.obuense (IMM-101) 1.0 mg|Each patient will receive an intradermal placebo injection of borate buffered saline solution (day -3) to provide an intra patient placebo control. Patients who were willing and able to proceed with the study will receive an intradermal injection of a single dose level of IMM 101 on three subsequent occasions. Doses of IMM 101 were administered over a 4 week period on days 0, 14 and 28.
16210905|NCT01308749|Drug|Oxytocin|"Subjects will use the Syntocinon® Nasal Spray (oxytocin) twice daily for 8 weeks if they are randomized to that arm in the Randomized Phase. All subjects will use the Syntocinon® Nasal Spray twice daily for 8 weeks in the Open Label Phase.
~Subjects ages 3-10 years old will be titrated up to a maximum dose of 24 International units (IU). Subjects ages 11-17 years old will be titrated up to a maximum dose of 32IU."
16210906|NCT01308749|Drug|Placebo|Placebo Nasal Spray
16210907|NCT01308736|Drug|Varenicline|Participants randomized to receive varenicline will follow the Pfizer recommended dosing schedule (0.5 mg QD on days 1-3, 0.5 mg BID on days 4-7, and 1 mg BID thereafter.
16210908|NCT01308736|Drug|Placebo pill|Participants randomized to receive placebo pill will follow the same dosing schedule as those randomized to receive varenicline (1 pill labelled 0.5 mg on days 1-3, pills labelled 0.5 mg BID on days 4-7, and pills labelled 1 mg BID thereafter.
16210909|NCT01308723|Drug|RO5323441|escalating doses iv
16210910|NCT01308723|Drug|RO5323441|iv every 2 weeks
16210911|NCT01308723|Drug|sorafenib|400 mg orally twice daily to once every other day
16210912|NCT01308710|Dietary Supplement|Omega-3 fatty acid (Eicosapentaenoic acid)|1.0 grams daily for 6 weeks
16210913|NCT01308697|Procedure|Operative fixation of flail chest|Plate fixation
16210914|NCT01308697|Other|Non Operative management|Non Operative treatment of Flail Chest
16210915|NCT01308684|Drug|RO5323441 + bevacizumab [Avastin]|Dose-Finding part: RO5323441 intravenous escalating doses once every two weeks; Efficacy-Finding part: established dose from the Dose-Finding part; Avastin: 10 mg/kg intravenously once every two weeks
16210916|NCT01308684|Drug|bevacizumab [Avastin]|Efficacy-Finding part: 10 mg/kg intravenously once every two weeks
16210917|NCT01308671|Drug|Varenicline|Varenicline will be administrated 0.5 mg Qd for 3 days,0.5 mg Bid for 4 days, and then 1 mg Bid for 14 days
16210918|NCT01308671|Behavioral|Counseling and psychosocial support|Blank group will receive the same counseling and psychosocial support as varenicline group
16210919|NCT01308658|Drug|Darunavir (DRV)|2x400-mg DRV tablet or 800-mg tablet
16210920|NCT01308658|Drug|ritonavir|on Day 3
16210921|NCT01308645|Drug|SB injection|Infusion SB injection of 21.87 ml/m^2, IV route, 24 times for 4 months
16210922|NCT01308632|Drug|Temozolamide, irinotecan|"Phase I trial:
~TMZ will be administered in a fixed schedule as follows:
~TMZ 50 mg/m2/day divided in three daily doses (approx. 17 mg/m2/8 hours) on days 1-7, 9-21, and 23-28.
~100 mg/m2 in a morning single dose on days 8 and 22
~CPT-11 starting dose:
~100 mg/m2 on days 8 and 22, administered 3 to 6 hours after TMZ. (Level 1)
~One cycle = 28 days
~CPT-11 will be escalated in successive cohorts of 3 patients as follows: 115, 130, 145, 160 mg/m2 ."
16210923|NCT01308619|Drug|Doxycycline|doxycycline 40 mg (30 mg immediate release / 10 mg delayed release beads) Capsules, oral, one capsule daily in the morning
16210924|NCT01308619|Other|Placebo|Placebo, oral, one capsule daily in the morning
16210925|NCT01308606|Drug|TMC435 HPMC capsule|Single intake of one 150-mg capsule without food
16210926|NCT01308606|Drug|TMC435 HPMC or gelatin capsule|Single intake of one 150-mg capsule after high-fat breakfast
16210927|NCT01308606|Drug|TMC435 HPMC or gelatin capsule|Single intake of one 150-mg capsule without food
16210928|NCT01308606|Drug|TMC435 HPMC or gelatin capsule|Single intake of one 150-mg capsule after standardized breakfast
16210929|NCT01308606|Drug|TMC435 gelatin capsule|Single intake of one 150-mg capsule without food
16210930|NCT01308593|Device|Juvederm XC|Filler
16210931|NCT01308593|Drug|Botox|26 units dosed one time
16210932|NCT01308580|Drug|Cabazitaxel (XRP6258)|"Pharmaceutical form: Concentrate and solvent for solution for infusion
~Route of administration: Intravenous"
16210933|NCT01308580|Drug|Prednisone (or Prednisolone)|"Pharmaceutical form: Tablet
~Route of administration: Oral"
16210934|NCT01308567|Drug|Cabazitaxel (XRP6258)|Pharmaceutical form: Solution for injection; Route of administration: Intravenous
16210935|NCT01308567|Drug|Docetaxel (XRP6976)|Pharmaceutical form: Solution for injection'; Route of administration: Intravenous
16210936|NCT01308567|Drug|Prednisone|Pharmaceutical form: Tablet; Route of administration: Oral
16210937|NCT01308554|Drug|Placebo: sterile normal saline|Bilateral TAP block using 20 ml of normal sterile saline per block.
16210938|NCT01308554|Drug|Marcaine|Study group will receive a bilateral TAP block using 20 ml of 0,25% Marcain on each side.
16210939|NCT01308541|Drug|arm 1|"Bolus Dose: two bolus doses of 15.0 mg/kg (first dose) and 8.0 mg/kg (second dose), 40 minutes apart.
~Continuous Infusion Dose: Total dose of 42.0 mg/kg administered over 3 hours at an infusion rate of 0.40 mg/kg/min for 1 hour, followed by 0.20 mg/kg/min for 1 hour, followed by 0.10 mg/kg/min for 1 hour."
16210940|NCT01308541|Drug|LUSEDRA|Mode of administration: intravenous (IV).Continuous Infusion Dose: Total dose of 42.0 mg/kg administered over 3 hours at an infusion rate of 0.40 mg/kg/min for 1 hour, followed by 0.20 mg/kg/min for 1 hour, followed by 0.10 mg/kg/min for 1 hour.
16210941|NCT01308541|Drug|Propofol (arm 3)|Mode of administration: intravenous (IV). A loading dose administered at a constant infusion rate of 0.20 mg/kg/min (0.50 mL/kg/min) for 10 minutes, followed by a constant-rate 2-hour infusion at 0.10 mg/kg/min; total dose infused over 130 minutes is 14.0 mg/kg.
16210942|NCT01308528|Drug|Sodium enoxaparin|40 mg/mL
16210943|NCT01308528|Drug|Sodium Enoxaparin clexane|clexane 40 mg/ 0,4 mL
16210944|NCT01308515|Device|Vanguard Knee System with AS Bearing|FDA cleared Tibial bearing that stabilizes the knee with an anterior lip, and is used with FDA cleared Vanguard CR (Cruciate Retaining) Femoral Component.
16210945|NCT01308515|Device|Vanguard Knee System with PS Bearing|FDA cleared Tibial bearing that stabilizes the knee with a post that articulates with the FDA cleared Vanguard PS(Posterior Stabilizing) Femoral Component.
16210946|NCT01308502|Device|Dx-pH probe|Dx-pH probe with 24 hour recording
16210947|NCT01308489|Procedure|therapeutic conventional surgery|Undergo posterior spinal tumor resection
16210948|NCT01308489|Procedure|therapeutic conventional surgery|Undergo anterior and posterior spinal tumor resection
16210949|NCT01308489|Procedure|quality-of-life assessment|Ancillary studies
16210950|NCT01308476|Procedure|SMS reminder|daily SMS in the SMS group to remind of treatment with tiotropium
16210951|NCT01308476|Procedure|control group|no daily SMS to remind of treatment with tiotropium
16211055|NCT01307618|Biological|Recombinant Interleukin-12|Given SC or ID
16210953|NCT01308437|Biological|Wosulin (N or 70/30 with R)|Basal bolus conventional Insulin viz. Wosulin (N or 70/30 with R) to be injected subcutaneously.
16210954|NCT01308437|Biological|Novolin® (N or 70/30 with R)|Basal bolus conventional Insulin viz. Novolin® (N or 70/30 with R) to be injected subcutaneously.
16210955|NCT01308424|Drug|BTL TML HSV|Sublingual micro-dosing for 7 days
16210956|NCT01308424|Drug|Matching placebo|sublingual dosing for 7 days
16210957|NCT01308411|Other|50% step down reduction in inhaled corticosteroid dose|All participants will have their inhaled corticosteroid dose reduced by 50%
16210958|NCT01308385|Other|Conditioned pain modulation|When evaluating conditioned pain modulation, pressure pain threshold in the musculus quadriceps femoris act as test stimulus and 2 minutes cold pressor test (stirred ice and water) acts as the conditioning stimulus. The difference between pain thresholds before and after the cold pressor test is defined as the effect of CPM.
16210959|NCT01308359|Drug|IV glucose 5%|500 ml glucose 5% within 30 minutes
16210960|NCT01308359|Drug|saline|saline
16210961|NCT01308346|Device|Bioabsorbable Vascular Solutions Everolimus Eluting Coronary Stent System (BVS EECSS)|Bioabsorbable Everolimus Eluting Coronary Stent
16210962|NCT01308346|Device|XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)|XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)
16210963|NCT01308320|Drug|fentanyl citrate|According to the enrolled group, certain dose of fentanyl is intravenously administered by bolus just after sevoflurane discontinuation.
16210964|NCT01308320|Drug|saline|According to the enrolled group, certain dose of saline is intravenously administered by bolus just after sevoflurane discontinuation.
16210965|NCT01308307|Device|photorefraction|photorefraction is a name of device.
16210966|NCT01308294|Biological|2 vaccine injections in 1 limb|Participants receive the vaccine separated in 2 syringes with syringe 1 containing NA-17, MAGE-3.A2 and NY-ESO-1 peptides with IMP321/LAG3 ± Montanide, and syringe 2 containing Melan-A and MAGE-A3-DP4 peptides with IMP321/LAG-3 ± Montanide. The content of each syringe is injected s.c. in the same limb at about 5 cm distance from each other.
16210967|NCT01308294|Biological|2 vaccine injections in distinct limbs|Participants receive the vaccine separated in 2 syringes with syringe 1 containing NA-17, MAGE-3.A2 and NY-ESO-1 peptides with IMP321/LAG3 ± Montanide, and syringe 2 containing Melan-A and MAGE-A3-DP4 peptides with IMP321/LAG-3 ± Montanide.The content of each syringe is injected s.c. in different limbs.
16210968|NCT01308294|Biological|"2 vaccine injections in distinct limbs"|
16210969|NCT01308281|Procedure|PCI with IVUS guidance|Patients will be randomized in a two-by-two factorial manner according to the use of IVUS guidance (IVUS guidance vs. no IVUS guidance) for the PCI and the duration of dual anti-platelet therapy (100 mg/day aspirin and 75mg/day clopidogrel for 6 months vs. 12 months) after PCI. Each randomization of the enrolled subjects will be done 1:1.
16210970|NCT01308281|Procedure|PCI without IVUS guidance|Patients will be randomized in a two-by-two factorial manner according to the use of IVUS guidance (IVUS guidance vs. no IVUS guidance) for the PCI and the duration of dual anti-platelet therapy (100 mg/day aspirin and 75mg/day clopidogrel for 6 months vs. 12 months) after PCI. Each randomization of the enrolled subjects will be done 1:1.
16210971|NCT01308268|Drug|Ivermectin + Albendazole|Ivermectin: 200µg/kg, single dose, PO + Albendazole 200 (children between 12 and 23 months) or 400 mg (>= 2 years old) single dose, PO
16210972|NCT01308255|Drug|Infliximab|"Prior to week 26
~Infliximab 3mg/kg standard regime (weeks 0, 2, 6, 14, 22)
~Methotrexate commencing at 10mg weekly, progressing to 20mg by week 6.
~Folic acid 5 mg daily except the day methotrexate is taken
~Patients will be unblinded at week 26 and then treated pragmatically guided by disease activity"
16210973|NCT01308255|Drug|Methylprednisolone|Steroid
16210974|NCT01308255|Drug|Methotrexate|All patients enrolled are commenced on oral methotrexate 10mg once a week The methotrexate dose should be increased to 15 mg at the week 2 visit. The methotrexate should be increased to 20mg at the week 6 visit.
16210975|NCT01308255|Dietary Supplement|Folic acid|All patients enrolled are commenced on oral folic acid 5mg daily, except the day methotrexate is taken, and the study infusions.
16210976|NCT01308242|Drug|Sevelamer Carbonate|Sevelamer 800 mg by mouth three times daily with meals for 3 months
16210977|NCT01308229|Device|Nile PAX® paclitaxel-eluting coronary stent|Implantation of a Nile PAX bifurcation dedicated drug-eluting stent in coronary arteries to treat stenosis lesions
16210978|NCT01308216|Procedure|low level laser therapy procedure|Transcranial low level laser therapy by automatic scanning noncontact over both cerebral hemispheres.
16210979|NCT01308203|Drug|Extended release niacin/laropiprant|Randomized patient will received 1 tablet of 1g ERN/20 mg LRPT for the first 4 weeks of treatment. At week 4 (± 2 days)the patient will be assessed in the outpatient clinic. Patients with good tolerance to the study medication will receive 2 tablets of 1 g ERN/20 mg LRPT that should be taken together for the next 8 weeks. At week 12 (± 2 days), patients will be assessed in the outpatient clinic patients and will be crossed over to placebo.
16210980|NCT01308203|Drug|placebo|Randomized patient will received 1 oral 1 g tablet of placebo for the first 4 weeks of treatment. At week 4 (± 2 days), after randomization the patient will be assessed in the outpatient clinic. Patients with good tolerance to the study medication will receive 2 oral 1 g tablets of placebo that should be taken together for the next 8 weeks. At week 12 (± 2 days), patients will be assessed in the outpatient clinic patients and will be crossed over to active medication.
16210981|NCT01308190|Drug|Capecitabine (Xeloda)|Capecitabine 825 mg/m2 every 12 hours orally on days of radiotherapy
16210982|NCT01308190|Radiation|50.4 Gy|Radiotherapy was administered in daily fractions of 1.8 Gy 5 days a week according to standard schema. The total dose is 45 Gy plus a boost of 5.4 Gy to the tumor area
16210983|NCT01308190|Procedure|Transanal Endoscopic Microsurgery|6-8 weeks after Chemoradiotherapy
16210984|NCT01308190|Procedure|Total Mesorectal Excision|Standard surgical treatment of T2 , T3s, N0, M0 rectal cancer. Early after diagnosis
16210985|NCT01308177|Drug|Ecabet|comparison between PPI+ ES (lanston 30mg bid+ ES 1g/1.5g/pkg bid) and PPI+placebo (lanston 30mg bid)for 28 days
16210986|NCT01308164|Device|MD Logic Pump Advisor|Insulin pump setting (i.e basal plan, correction factor, carbohydrate ratio and insulin activity time)will be adjusted using the MD-LOgic Pump Advisor
16210987|NCT01308151|Other|Other|No interventions other than the culturally adapted manualised cognitive behavioral therapy
16210988|NCT01308138|Behavioral|Exercise training|exercise training
16210990|NCT01308125|Procedure|PICSO|"Baseline (hemodynamic) measurement
~Intra coronary
~Blood sampling
~LAD occlusion: for 3 min or until pain with and without PICSO
~Break recovery: the patient can recover from pain for 3 min
~CFIp: by a ComboWire advanced in the center lumen of an occlusion balloon.
~PICSO: start automatically and continued for 10 min.
~PCI/PICSO: concomitantly for the whole duration of the PCI intervention.
~24h Follow up: additional blood samples every 6 hours (4 times)
~30 days follow up."
16210991|NCT01308112|Dietary Supplement|iron|Daily supplementation with iron (60 mg) as ferrous sulphate
16210992|NCT01308099|Device|Blood Pressure and Blood Flow|"A blood pressure cuff will be placed on one arm and small probes on one finger on both hands. The probes also measure blood pressure. After 10 minutes, the arm blood pressure cuff will be inflated. The cuff will stay inflated for 5 minutes, then the air will be let out. A cuff will be place above the left calf and the left knee. The subject will lie quietly for 9 minutes, then blood pressure and calf blood flow will be measured for one minute. the lower leg cuff will be inflated after 1 minute, then the cuff will be deflated. The blood pressure and forearm blood flow will be recorded. Next, the cuff on the upper leg will be inflated for 5 minutes then, it will be released and the measurements of blood pressure and calf blood flow will be repeated.
~The study lasts about 2 hours."
16210993|NCT01308086|Drug|5-Fluorouracil|5-FU 400mg/m2 Bolus and then 22 hours 5-FU 600mg/m2 IV, days 1 & 2, q2w, for 12 cycles
16210994|NCT01308086|Drug|Leucovorin|Leucovorin 200mg/m2 IV in 2 hours, days 1 & 2, q2w, for 12 cycles
16210995|NCT01308086|Drug|Oxaliplatin|Oxaliplatin 85mg/m2 in 2 hours IV, day 1, q2w, for 12 cycles
16210996|NCT01308086|Drug|Capecitabine|Capecitabine 1000 mg/m2 X 2 ,days 1-14, q2w, for 8 cycles
16210997|NCT01308086|Drug|Oxaliplatin|Oxaliplatin 130 mg/m2 in 2 hours IV, day 1, q2w, for 8 cycles
16210998|NCT01308086|Drug|5-Fluorouracil|5-FU 400mg/m2 Bolus and then 22 hours 5-FU 600mg/m2 IV, days 1 & 2, q2w, for 6 cycles
16210999|NCT01308086|Drug|Leucovorin|Leucovorin 200mg/m2 IV in 2 hours, days 1 & 2, q2w, for 6 cycles
16211000|NCT01308086|Drug|Capecitabine|Capecitabine 1000 mg/m2 X 2 ,days 1-14, q2w, for 4 cycles
16211001|NCT01308086|Drug|Oxaliplatin|Oxaliplatin 130 mg/m2 in 2 hours IV, day 1, q2w, for 4 cycles
16211002|NCT01308086|Drug|Oxaliplatin|Oxaliplatin 85mg/m2 in 2 hours IV, day 1, q2w, for 6 cycles
16211003|NCT01308073|Device|Hemodialysis with EMIC 2 filters|Patients with indication for routine continuous hemodialysis due to acute renal insufficiency
16211004|NCT01308060|Drug|Botulinum Toxin Type A|During part A, Azzalure will be administered at Baseline 60 Speywood units at canthal lines and compared with placebo.
16211005|NCT01308060|Other|Placebo|
16211006|NCT01308047|Drug|Bupivacaine|single dose of 15mg by a slow injection rate of 1 ml/s
16211007|NCT01308034|Drug|sunitinib|"All patients will be treated with sunitinib (3 dose level) once a day (in the morning) for 6 weeks in association with radiotherapy.Radiotherapy will be realised 1-4h after taking sunitinib.
~Dose level 1 : 12.5 mg once daily Dose level 2 : 25 mg once daily Dose level 3 : 50 mg once daily. Authorization to include a patient in the upper step will be given only if the deadline of 14 weeks after the start of treatment of last patient included were strictly respected and depending of number of DLT occuring."
16211008|NCT01308021|Biological|gpASIT+TM|entero-coated capsules containing 400µg of gpASIT+TM, daily , 28 days
16211009|NCT01308021|Biological|gpASIT+TM|entero-coated capsules containing 800 µg of gpASIT+TM, daily, 28 days
16211010|NCT01308021|Biological|Placebo|Placebo entero-coated capsules
16211011|NCT01308008|Behavioral|home exercise/physical activity (PA) enhancement program with behavioral support|Initial on-site personal trainer-based functional aerobic program followed by home intervention consisting of functional exercise training and enhanced physical activity with nurse telephonic behavioral support
16211012|NCT01308008|Behavioral|flex and toning health education program|Initial flex and toning program continued on follow-up along with health education
16211013|NCT01307982|Procedure|Fundoplication|During fundoplication surgery, the upper curve of the stomach (the fundus) is wrapped around the esophagus and sewn into place so that the lower portion of the esophagus passes through a small tunnel of stomach muscle. This surgery strengthens the valve between the esophagus and stomach (lower esophageal sphincter), which stops acid from backing up into the esophagus as easily.
16211014|NCT01307982|Procedure|Gastrojejunal (GJ) feeding tube|Gastrojejunal (GJ) tube placement is an image guided technique in which a special soft feeding catheter is placed through an existing hole in the stomach (gastrostomy) into the small bowel (jejunum).
16211015|NCT01307969|Drug|Ropivacaine|1,8 mL of the local anesthetic formulations were injected at the apex of the maxillary right canine.
16211016|NCT01307956|Drug|Fluorouracil|Given IV
16211017|NCT01307956|Other|Laboratory Biomarker Analysis|Correlative studies
16211018|NCT01307956|Drug|Leucovorin Calcium|Given IV
16211019|NCT01307956|Drug|Oxaliplatin|Given IV
16211020|NCT01307956|Biological|Panitumumab|Given IV
16211021|NCT01307956|Other|Pharmacological Study|Correlative studies
16211022|NCT01307956|Radiation|Radiation Therapy|Undergo radiation therapy
16211023|NCT01307956|Procedure|Therapeutic Conventional Surgery|Undergo surgical resection
16211024|NCT01307943|Other|Mindfulness-based stress reduction program|Eight MBSR sessions of 2 hrs/week to be held during regular class time plus one 3-hour retreat
16211025|NCT01307943|Other|Usual care|The site provides family centered treatment where adolescents take part in therapy from Sunday evening until Friday afternoon. In addition to a structured day and evening schedule, standard treatment includes: Daily group therapy; ii) Medications; iii) Schooling by Edmonton Public School Board teachers; iv) Physical education and recreation; and v) Weekly Multiple Family Therapy.
16211026|NCT01307930|Drug|Anidulafungin|Anidulafungin 100 mg IV (each volunteer will only receive one dose of the study drug)
16211027|NCT01307917|Dietary Supplement|flavonoids|for 14 days, one dose two times per day, subjects will ingest a flavonoid-rich capsule containing 500 mg flavonoids or a placebo capsule made, stored, and dispensed by TTUHSC Pharmacy, with a similar look and taste.
16211028|NCT01307904|Other|Glucose|Each healthy and Diabetic volunteers received 50 grams of glucose
16211029|NCT01307904|Other|Dates|Each healthy and diabetic volunteers received 50 grams equivalent of carbohydrates of each of the five selected dates, on five separate days.
16211056|NCT01307618|Biological|MART-1 Antigen|Given SC or ID
16211030|NCT01307891|Drug|Abraxane alone|100 mg/m2 weekly X 3 doses (Days 1, 8, 15) at 28-day intervals until disease progression or unacceptable toxicity. Abraxane will be administered on an outpatient basis by an IV infusion over 30 minutes. Patients will be evaluated for response every 2 cycles (every 8 weeks).
16211031|NCT01307891|Drug|Abraxane + Tigatuzumab|Tigatuzumab will be administered as a loading dose of 10 mg/kg on Day 1, then 5 mg/kg on Day 15 and then every other week on Days 1 and 15 of subsequent cycles. It will be given as an IV infusion over 60 minutes or less. No dose reductions will be allowed. Tigatuzumab will be administered in combination with the Abraxane according to the intervention described for it.
16211032|NCT01307878|Drug|chemotherapy ± targeted therapy|FOLFOX 6 ± targeted therapy
16211033|NCT01307865|Drug|injectable poly-L-lactic acid|Each patient will receive up to 1 vial of Sculptra Aesthetic total to both midface complexes at each of 3 treatment sessions, spaced 6 weeks apart.
16211034|NCT01307852|Device|Plastic Scintillation Detectors|Radiation detectors attached to rectal balloon for each CT scan done during each radiation treatment. Treatment delivery Monday through Friday for 7 weeks.
16211035|NCT01307839|Drug|5% lidocaine patch|Research intervention: After consent has been given, either an active 5% lidocaine patch or an inactive placebo patch will be placed on the lumbar spine of the patient. Both patches appear identical to the physician. The team will then wait for the patient to request an epidural due to labor pain, a minimum of 30 minutes from patch placement and a maximum of 12 hours.
16211036|NCT01307839|Drug|placebo patch|Research intervention: After consent has been given, either an active 5% lidocaine patch or an inactive placebo patch will be placed on the lumbar spine of the patient. Both patches appear identical to the physician. The team will then wait for the patient to request an epidural due to labor pain, a minimum of 30 minutes from patch placement and a maximum of 12 hours
16211037|NCT01307826|Other|massage|"session - 20 minutes.
~Before the massage, palpable evaluation of the selected anatomical structures was carried out - to determine which tissues have the greatest sensitivity and which motor organs show increased tension (by pressing the attachment). In all the examined patients, pain of the following muscle attachments were shown:
~latissimus muscle of the back
~major pectoral muscle
~supraspinous and infraspinous muscles
~teres minor muscle
~serratus anterior muscle
~deltoid muscle The decision which muscles and fascias have to be massaged was made on the basis of the performed evaluation. In most cases the above mentioned tissues (together with other motor system organs which are structurally linked to it) were massaged to relax them.
~A palpable evaluation of the previously examined points was again performed during the final part, with particular attention paid to painful muscles, in order to analyze the effectiveness of the performed relaxation."
16211038|NCT01307826|Other|massage|classical massage (Swedish massage)
16211039|NCT01307813|Device|Overstitch Endoscopic Suturing System|"Assess the safety and effectiveness of the Apollo endoscopic suturing device (Overstitch) and cinching device for placement of sutures and surgical knots in a segment of colon under laparoscopic or open visualization of the operative area.
~Patients will already require resection of segments of colon for treatment of benign or malignant disease and this will therefore be a treat and resect model"
16211040|NCT01307800|Drug|LY2140023|Administered orally
16211041|NCT01307800|Drug|Placebo|Administered orally
16211042|NCT01307787|Other|experimental Fit-program|Participants in the intervention group followed an eight week multi-disciplinary group rehabilitation program, consisting of a physical exercise part and an educational component. The physical exercise part consisted of a muscle exercise circuit and bicycle training,sport and aqua jogging. The educational part consisted of a weekly sixty minutes session. A multi-disciplinary group of healthcare professionals gave specialist orientated informational advice about how to handle the consequences of RA. Special attention was paid to ensure adjusting the level of each patients activity level to the participants' actual energy level. Further information was given about body sensations, sports, food and energy, pain, fatigue, emotional changes, sleeping disturbance and daily routine.
16211043|NCT01307787|Other|no intervention|waiting list control group with no intervention
16211044|NCT01307748|Other|aroma|Comparison of known stress reducing aroma to placebo aromas without stress-reducing effects
16211045|NCT01307722|Other|left atrial distensibility-guiding prescription of heart failure drugs|This study is a prospective, observational, and open label investigation. The guide group will be followed 1 time per 2 week at first 3 months, then 1 time per month later, and then 1 time per 3 months. Each time, the guide group should receive echocardiography, including the measurement of LA distensibility. LA distensibility-guided therapy is enabled in 2 ways. Prescriptions should be adjusted according to overall left ventricular filling pressure estimated by LA distensibility. The specified treatments after adjustment by the current LA distensibility are also allowed. Investigators individually adjust medications for each patient according to the ranges of LA distensibility. The specified therapy is based on 5 LA distensibility ranges (very low, low, optimal, high, and very high). Each range is associated with a prescription for medication dosing, sodium and fluid intake, or activity level.
16211046|NCT01307683|Behavioral|Mindful Moms|"8 weekly 2-hour sessions, 2 booster telephone sessions, and 1 postpartum booster session"
16211047|NCT01307657|Other|high fat meal|Clopidogrel 600 mg loading dose at 8 am and high-fat meal at 12 pm
16211048|NCT01307644|Behavioral|Experimental: Web-based only (WO) weight intervention|The WO intervention included evidence-based lifestyle modification for healthy eating and activity, with self-monitoring and goal setting, and messages based on constructs from the Health Promotion Model across 3 phases. The intent of the phases was to deliver more intensive intervention during Phase 1, transitioning to less intensive intervention during phase 2, to providing support for self managed weight maintenance during Phase 3.
16211049|NCT01307644|Behavioral|Experimental: WO plus peer-led discussion board (WD)|Includes WO intervention plus asynchronous discussion board managed by peer leader, whose identity is masked. The peer leader who posted theme-based messages, called primers, that were consistent with WO themes across phases.
16211050|NCT01307644|Behavioral|Experimental: WO & professional email counseling (WE)|Includes WO intervention plus professional email counseling provided by a registered dietitian whose identity is masked. The email counselor is responsible for reviewing eating, activity, weight logs, and goals on the web-site and send e-mail feedback, in addition to responding to email questions. The e-mail process will follow the 5A's Model for Behavioral Counseling (assess, advise, agree, assist, and arrange) that was adapted for this study.
16211051|NCT01307631|Drug|Akt Inhibitor MK2206|Given PO
16211058|NCT01307605|Biological|Rituximab|Rituximab (MabThera®) will be administered for a maximum of 8 infusions at weeks 1, 2, 3, 4 and again at weeks 12, 13, 14, 15 if the first restaging at week 10 (+/- 1 week) shows a partial response with at least more than 25% reduction in sum of product of diameters
16211059|NCT01307605|Drug|lenalidomide|Lenalidomide will be administered as 15 mg flat dose daily, starting 14 days before first and stopping 14 days after last rituximab administration.
16211060|NCT01307592|Biological|rituximab|
16211061|NCT01307592|Drug|gemcitabine hydrochloride|
16211062|NCT01307592|Drug|lenalidomide|
16211063|NCT01307592|Drug|oxaliplatin|
16211064|NCT01307579|Drug|Caspofungin Acetate|Given IV
16211065|NCT01307579|Drug|Fluconazole|Given IV or PO
16211066|NCT01307579|Other|Laboratory Biomarker Analysis|Correlative studies
16211067|NCT01307566|Device|Continuous Positive Airway Pressure CPAP|CPAP treatment
16211068|NCT01307553|Device|Pericardium Covered Stent|Percutaneous implantation of pericardium covered stent
16211069|NCT01307540|Device|phototherapy|low level light therapy, broad band light wavelengths.
16211070|NCT01307527|Drug|Riboflavin|0.1%, applied every 5 minutes for 60 minutes
16211071|NCT01307527|Device|Kera-X|3 mW/cm2, to the central 7.5 mm of the cornea, for 30 minutes
16211072|NCT01307501|Device|Cryoablation|Application of extremely cold temperatures to the identified tumor(s).
16211073|NCT01307488|Drug|Ritonavir boosted Atazanavir + Lamivudine|ATV/RTV 300/100 mg QD + 2 optimized NRTIs for the first 4 weeks and then they will receive ATV/RTV 300/100 mg QD (once daily) and 3TC 300 mg QD for another 92 weeks. Treatment should be taken orally with a light meal at the same time each day.
16211074|NCT01307488|Drug|Ritonavir boosted Atazanavir + 2 NRTIs|ATV/RTV 300/100 mg QD + 2 optimized NRTIs for 96 weeks. Treatment should be taken orally with a light meal at the same time each day.
16211075|NCT01307475|Other|PTSD Checklist-Specific|Completed by patients before clinical examination; it is a 17-item survey listing of symptoms of posttraumatic stress disorder.
16211076|NCT01307475|Other|Modified Flanagan Quality of Life Scale|Completed by patients before clinical examination; it is a 16-item survey designed for use in persons with chronic illness.
16211077|NCT01307475|Other|Center for Epidemiologic Studies Depression Scale|Completed by patients before clinical examination; it is a 20-item survey that asks about depressive feelings and behaviours in the past week.
16211078|NCT01307475|Other|Functional Enquiry Form|Completed by patients before clinical examination; it is a checklist of medical problems.
16211079|NCT01307475|Other|Strength, Joint ROM, Girth and Length Measurements|Completed during the clinical examination by the researchers, it is a structured approach to evaluation of muscles, joints, arms, thighs, and legs.
16211080|NCT01307475|Other|Study Physical Examination|Completed during the clinical examination by the researchers, it is a structured approach to a full physical examination, minus breasts, genitalia or rectum.
16211081|NCT01307475|Other|PTSD, Depression, and FSS-Focused Examination|Completed during the clinical examination by the researchers, it is a structured approach to evaluation of symptoms, signs, and perceptions that may be related to FSS, PTSS, or depressive problems.
16211082|NCT01307475|Other|Freeman-Sheldon Specific Quality of Life Survey|Completed after data analysis from the existing surveys and clinical examination, it will be a specific quality of life survey developed and tested during the study; it will take into consideration individual's total health outcome.
16211083|NCT01307475|Other|Lactate, Glucose, and Adenosine Triphosphate Blood Levels|Completed during the clinical examination by the researchers, lactate, glucose, and free and total adenosine triphosphate blood levels are determined at rest.
16211084|NCT01307462|Drug|fluticasone propionate|Given inhaled PO
16211085|NCT01307462|Drug|montelukast sodium|Given PO
16211086|NCT01307462|Drug|azithromycin|Given PO
16211087|NCT01307449|Biological|PNEUMOVAX|1 dose of PNEUMOVAX
16211088|NCT01307449|Biological|Prevnar|1 dose of Prevnar
16211089|NCT01307436|Biological|Epaxal|0.25ml Epaxal: at least 12 IU hepatitis A antigen coupled to immunopotentiating reconstituted influenza virosomes (IRIV)
16211090|NCT01307436|Biological|Havrix 720|0.5ml Havrix 720: at least 720 EU hepatitis A antigen adsorbed onto aluminium hydroxide
16211091|NCT01307423|Drug|Apremilast 20mg|Apremilast 20mg twice daily, orally
16211092|NCT01307423|Drug|Apremilast 30mg|Apremilast 30mg twice daily, orally
16211093|NCT01307423|Drug|Placebo|Placebo
16211094|NCT01307397|Drug|Vemurafenib|Participants will receive continuous oral doses of vemurafenib 960 mg (four 240 mg tablets) twice daily in each 28-day treatment cycle until the development of progressive disease, unacceptable toxicity, consent withdrawal, protocol violations endangering participant's safety, death, or study termination by the Sponsor, whichever occurs first.
16211095|NCT01307384|Device|Continuum Metal on Polyethylene Acetabular System|Used in primary hip arthroplasty
16211096|NCT01307358|Other|Sonicare Interproximal (IP) Cleaning Prototype|Sonicare Interproximal (IP) Cleaning Prototype used to clean between the teeth 1 time a day in combination with brushing.
16211097|NCT01307345|Behavioral|contingency management for abstinence|For each breath sample submitted that reads below the cut point, participants will receive a voucher that can be exchanged for a check or gift card. Amounts earned will increase for each consecutive negative sample submitted, up to a maximum amount.
16211098|NCT01307332|Drug|MabCampath-1h|Drug:10 mg/mL alemtuzumab intravenous infusion. Form: Sterile, clear, colorless solution. Dosage: 2 cycles. Month 0 dosed over 5 consecutive days; month 12 dosed over 3 consecutive days.
16211099|NCT01307319|Drug|BDP HFA|BDP (beclomethasone dipropionate) HFA (hydrofluoroalkane) nasal aerosol administered as a single actuation in each nostril daily for the 15 day treatment period. Each actuation contains either 40 or 80 mcg for a total daily dose of either 80 or 160 mcg depending upon the assigned treatment arm.
16211100|NCT01307319|Drug|Placebo nasal aerosol|Placebo formulated as a nasal aerosol spray and administered as a single actuation in each nostril daily for the 15 day treatment period.
16211101|NCT01307306|Drug|Humulin R|Humulin R (U-100) will be given i.v. The dose given will be adjusted in order to achieve a blood glucose level of 130-140 mg/dl.
16211102|NCT01307306|Drug|Metformin|Metformin 850 mg q. 8 hours will be given to decrease blood glucose to 130-140 mg/dl.
16213994|NCT01284959|Drug|placebo|lactose PO, 3times
16211103|NCT01307293|Behavioral|Cognitive behavior therapy|6 or 12 sessions of cognitive behavior therapy.
16211104|NCT01307280|Behavioral|RCT1|the bookHEALTH manual and eHEALTH tools, the basic Internet component of the intervention
16211105|NCT01307280|Behavioral|RCT2|bookHEALTH and an interactive version of eHEALTH that provided tailored computerized feedback whenever participants submitted weekly assessments
16211106|NCT01307280|Behavioral|RCT3|bookHEALTH, the interactive version of eHEALTH, and telephonic coaching support provided by trained health lifestyle coaches every 2 weeks alternating between a telephone call (typically 15 to 20 minutes) and a personalized e-mail. The coaches used motivational interviewing, helped participants solve problems, and reinforced their successes.
16211107|NCT01307267|Drug|PF-05082566|Intravenous, Dose escalation, once per month
16211108|NCT01307267|Drug|rituximab|Intravenous, 375 mg/m2, once per week for 4 weeks
16211109|NCT01307267|Drug|PF-05082566|IV, Dose escalation, once per month
16211110|NCT01307254|Procedure|blood analysis|A single venous blood test will be taken - 4 tubes (hematology, clotting, chemistry, sedimentation rate)
16211111|NCT01307228|Other|Health Systems Evidence|Health Systems Evidence (HSE) contains over 1400 research syntheses about governance, financial and delivery arrangements within health systems and about implementation strategies relevant to health systems. The syntheses have been: 1) categorized by topic, type of synthesis, and type of question addressed; 2) coded by the last year in which searches for studies were conducted and by the countries in which included studies were conducted; 3) rated for quality; and 4) linked to publicly available user-friendly summaries, scientific abstracts, and full-text reviews. We identified systematic reviews in HSE that are not accessible to study participants and developed a mechanism to reimburse publishers for full-text downloads of these reviews.
16211112|NCT01307215|Drug|Ropivacaine|20mLs of 0.5%
16211113|NCT01307215|Drug|Ropivacaine|30mLs of 0.33%
16211114|NCT01307215|Drug|Ropivacaine|40mLs of 0.25%
16211115|NCT01307202|Drug|Gabapentin|600mg of Gabapentin will be given orally preoperatively and 200mg for 3 times a day after surgery for 3 days
16211116|NCT01307202|Drug|Placebo|Placebo will match the the gabapentin pill and will be given orally.
16211117|NCT01307189|Drug|Tiotropium|Tiotropium diskus inhalation powder, 18ug, once daily
16211118|NCT01307189|Drug|Placebo|Placebo diskus inhalation powder, once daily
16211119|NCT01307176|Behavioral|Home exercise program|The home exercise program uses standard physical therapy exercises that have never been rigorously tested for people with cerebellar ataxia. These include sitting balance exercises (e.g. sitting on a peanut-shaped exercise ball and moving arms or legs), standing balance exercises (e.g. weight shifting, moving arms and legs), and walking exercises (e.g. walking heel-to-toe). The exercises are in a progression, going from less to more challenging. Though the exercises are standard, they are the intervention that we are testing and we will consider them experimental.
16211120|NCT01307137|Behavioral|Peer-led intervention|"An expert patient in the peer-led intervention will provide effective support for patients and families to accelerate adoption of CER for diabetes prevention and management in the elderly. This will lead to better self-efficacy and clinical outcomes.
~Those veterans enrolled in the MOVE! and HARC programs that have showed success in management of weight and Diabetes will be offered to become peer-leaders.
~Weight management success is defined as a loss of at least 5% of the weight since enrollment
~Diabetes management will be defined as adequate control of HbA1c and/ or blood pressure and lipids.
~The potentials peer-leaders will have a pre-assessment test to evaluate diabetes prevention and management knowledge and motivation and support skills."
16211121|NCT01307137|Behavioral|Telehealth Intervention|Participants in the TAP group will receive mobile phones that will be programmed to monitor specific clinical parameters and promote adoption of CER on prevention and management of diabetes, with protocols developed in part based on the input from the focus groups. These devices display messages, tips, reminders and questions regarding healthy lifestyle and clinical parameters of diabetes, which will be developed using best practice guidelines. Participants will be asked to respond to the questions daily if they can. Also they are asked to provide their daily weight, blood pressure, and glucose levels (the later only for patients with diabetes).
16211122|NCT01307124|Drug|kaletra|"The study participants will receive Lopinavir/ritonavir heat-stable tablet (100/25 mg or 200/50 mg) q 12 hour plus NRTIs. The other NRTIs is depend on physician discretion.
~Arm 1:LPV/r Standard dose Arm 2:Low dose BW 25-35 kg 300/75 mg 200/50 mg BW >35-50 kg 400/100 mg 300/75 mg"
16211123|NCT01307111|Drug|Misoprostol|400 micrograms inserted buccally or vaginally, per the participants desire prior to the IUD insertion.
16211124|NCT01307111|Drug|Placebo|Pills which are identical to the study drug in appearance, taste, and smell.
16211125|NCT01307098|Drug|Sebelipase alfa 0.35 mg/kg|Sebelipase alfa is a recombinant human lysosomal acid lipase.
16211126|NCT01307098|Drug|Sebelipase alfa 1 mg/kg|Sebelipase alfa is a recombinant human lysosomal acid lipase.
16211127|NCT01307098|Drug|Sebelipase alfa 3 mg/kg|Sebelipase alfa is a recombinant human lysosomal acid lipase.
16211128|NCT01307085|Procedure|remote ischemic preconditioning|Remote ischaemic preconditioning consisted of three 5-min cycles of right upper limb ischaemia, induced by an automated cuff-inflator placed on the upper arm and inflated to 200 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated.
16211129|NCT01307072|Procedure|Vitrectomy|Vitrectomy. Diabetic retinopathy
16211130|NCT01307059|Device|easypod™|Saizen (Somatotropin) as per Summary of Product Characteristics administered by easypod™
16211131|NCT01307046|Drug|MK-0954A|Tablet containing losartan potassium (100 mg) and hydrochlorothiazide (12.5 mg), once daily
16211132|NCT01307046|Drug|Losartan|Tablet containing losartan potassium (100 mg), once daily
16211133|NCT01307046|Drug|Placebo to MK-0954A|Placebo tablet to match MK-0954A, once daily
16211134|NCT01307046|Drug|Placebo to losartan 100 mg|Placebo tablet to match losartan 100 mg, once daily
16211135|NCT01307046|Drug|Placebo to losartan 50 mg|Placebo tablet to match losartan 50 mg, once daily
16211136|NCT01307033|Drug|MK-0954A|Tablet containing losartan potassium (100 mg) and hydrochlorothiazide (12.5 mg), once daily
16211137|NCT01307033|Drug|MK-954H|Tablet containing losartan potassium (50 mg) and hydrochlorothiazide (12.5 mg), once daily
16211138|NCT01307033|Drug|Placebo to MK-0954A|Placebo tablet to match MK-0954A, once daily
16211139|NCT01307033|Drug|Placebo to MK-954H|Placebo tablet to match MK-954H, once daily
16211140|NCT01307020|Drug|Dexketoprofen Trometamol|Dexketoprofen Trometamol low dose, oral film-coated table, once
16211141|NCT01307020|Drug|Dexketoprofen Trometamol|Dexketoprofen Trometamol high dose, oral film-coated table, once
16211142|NCT01307020|Drug|Tramadol Hydrochloride|Tramadol Hydrochloride low dose, oral film-coated table, once
16211143|NCT01307020|Drug|Tramadol Hydrochloride|Tramadol Hydrochloride high dose, oral film-coated table, once
16211144|NCT01307020|Drug|Ibuprofen|Ibuprofen 400 mg, oral film-coated table, once
16211145|NCT01307020|Drug|Placebo|Placebo, oral film-coated table, once
16211146|NCT01307020|Drug|Dexketoprofen Trometamol + Tramadol Hydrochloride|DKP-TRIS low dose - TRAM.HCl low dose, oral film-coated table, once
16211147|NCT01307020|Drug|Dexketoprofen Trometamol + Tramadol Hydrochloride|DKP-TRIS low dose - TRAM.HCl high dose, oral film-coated table, once
16211148|NCT01307020|Drug|Dexketoprofen Trometamol + Tramadol Hydrochloride|DKP-TRIS high dose - TRAM.HCl low dose, oral film-coated tablet, once
16211149|NCT01307020|Drug|Dexketoprofen Trometamol + Tramadol Hydrochloride|DKP-TRIS high dose - TRAM.HCl high dose, oral film-coated tablet, once
16211150|NCT01307007|Drug|Ferric Carboxymaltose (FCM)|15 mg/kg up to a maximum of 1000 mg intravenous diluted in 250 cc normal saline solution administered over 15 minutes on Day 0
16211151|NCT01307007|Drug|Iron Dextran Injection|Test dose of 25 mg administered over 5 minutes, if no reaction occurs then the remainder of the dose (15 mg/kg or 1000 mg including the test dose) will be administered as per investigator. The infusion must be given only when resuscitative techniques for the treatment of anaphylactic reactions are readily available.
16211152|NCT01306994|Other|Lactate, Glucose, and Adenosine Triphosphate Blood Levels|Completed during the clinical examination and exercise test by the researchers, lactate, glucose, and free and total adenosine triphosphate blood levels are determined at rest and during exercise.
16211153|NCT01306994|Procedure|Physiological Stress Test|During exercise, heart and lung function are monitored for changes caused by exercise, which increases the body's need for oxygen and puts extra demands on the heart. In this study, testing is done using a cycle ergometer and conducted according to the standardised exponential exercise protocol (STEEP).
16211154|NCT01306994|Other|Functional Enquiry Form|Evaluated before clinical examination, it is a checklist of medical problems.
16211155|NCT01306994|Other|Strength, Joint ROM, Girth and Length Measurements|Completed during the clinical examination by the researchers, it is a structured approach to evaluation of muscles, joints, arms, thighs, and legs.
16211156|NCT01306994|Other|Study Physical Examination|Completed during the clinical examination by the researchers, it is a structured approach to a full physical examination (minus breasts, genitalia, or rectum).
16211157|NCT01306994|Other|Observational Gait Analysis|Completed during the clinical examination by researchers, it is a structured approach to evaluation of a person's walking.
16211158|NCT01306994|Other|Mental Health Interview|Completed during the clinical examination by the researchers, it is a general evaluation of mental health status.
16211159|NCT01306981|Drug|Ranibizumab|Intravitreal injection of ranibizumab, 0.5mg in 0.05ml
16211160|NCT01306981|Drug|Saline|Subconjunctival injection of 0.05ml saline 0.9% w/v
16211161|NCT01306968|Drug|hyperbaric oxygen|"The chamber will be compressed with air to 1.5 atm abs. Once the chamber is compressed to 1.5 atm abs, the subjects will don a hood and breathe 100% oxygen. Hoods will be supplied with oxygen with flows of at least 30 liters per minute and overboard dumping of excess gas. Each subject will complete 40 sessions.
~The duration of the hyperbaric oxygen exposures will be 60 minutes (±2 minutes), timed from when the chamber hatch or door closes, and ending when the chamber hatch or door opens (door-to-door time equals 60 minutes). The total intervention exposure time is 50 minutes (±2 minutes). The interval to compress to the intervention pressure (1.5 atm abs) and will be 5 minutes (±1 minute). The interval to decompress from the study pressure will be 5 minutes (±1 minute)."
16211162|NCT01306968|Other|sham hyperbaric air|A pressure of 1.2 atm abs will provide an equivalent inhaled oxygen concentration of 25%. The duration of the sham exposures will be 60 minutes (±2 minutes). Each subject will complete 40 sessions.
16211163|NCT01306955|Drug|methylorednisolone|intravenous infusion of 1000 mg methylprednisolone in 100cc D/w 5% on 3 consecutive days at beginning of treatment
16211164|NCT01306955|Other|dextrose water 5%|intravenous infusion of 100cc D/w 5% on 3 consecutive days at beginning of treatment
16211165|NCT01306942|Drug|Dasatinib|
16211166|NCT01306942|Drug|Trastuzumab|
16211167|NCT01306942|Drug|Paclitaxel|
16211168|NCT01306929|Drug|pridopidine|45mg bid
16211169|NCT01306903|Device|MECC|Minimized extracorporeal circulation
16211170|NCT01306903|Device|MOPS|Modified and optimized perfusion system Frankfurt
16211171|NCT01306903|Device|Super MOPS|Super modified and optimized perfusion system Frankfurt
16211172|NCT01306890|Biological|sipuleucel-T|Each dose of sipuleucel-T contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF. The recommended course of therapy for sipuleucel-T is 3 complete doses, given at approximately 2-week intervals.
16211173|NCT01306877|Device|EEA Hemorrhoid and Prolapse Stapling Set|Surgical device
16211174|NCT01306877|Device|Endosurgery Proximate PPH03 Stapling Set|Surgical device
16211175|NCT01306864|Device|Hemospray Kit|Hemostasis of Arterial GI Bleeding
16211176|NCT01306851|Drug|Fibrin glue|In the intervention group, 5 or 10 ml of fibrin glue are applied in the anastomotic line.
16211177|NCT01306838|Dietary Supplement|MicroLipid and fish oil|Infants in treatment arm will receive the same nutrition support as control group before they tolerate enteral feeding at 20 ml/kg/day. Then they will receive study oils when feeds reach 30 ml/kg/day.
16211178|NCT01306838|Other|Routine care|Routine care
16211179|NCT01306786|Drug|Quadruple therapy|"First line: 5 days esomeprazole 20mg b.d., bismuth subcitrate 120mg q.i.d., tetracycline 250mg q.i.d. and metronidazole 250mg q.i.d.
~Cross over second line for those who failed first line: 7 days esomeprazole 20mg b.d., amoxicillin 1g b.d. and clarithromycin 500mg b.d"
16211180|NCT01306786|Drug|Triple therapy|First line: 7 days esomeprazole 20mg b.d., amoxicillin 1g b.d. and clarithromycin 500mg b.d Second line cross over if failed first line: 7 days quadruple therapy: esomeprazole 20mg b.d., bismuth subcitrate 120mg q.i.d., tetracycline 250mg q.i.d. and metronidazole 250mg q.i.d.)
16211323|NCT01305694|Biological|bone marrow derived mesenchymal stem cells|Intravenous administration of up to 6x10^5 MSCs per kg,qw,for 4 weeks
16211181|NCT01306773|Drug|H1N1 convalescent plasma and oseltamivir|Oseltamivir 75mg bid orally during ICU hospitalization + 500mL convalescent plasma containing >= 1:160 of neutralizing antibody to Pandemic influenza A H1N1
16211182|NCT01306773|Drug|Oral Oseltamivir alone|Oral Oseltamivir 75mg bid during ICU hospitalization
16211183|NCT01306760|Drug|Ketamine|Ketamine used as the anaesthetic during ECT.
16211184|NCT01306760|Drug|Propofol|The standard anaesthetic used for ECT.
16211185|NCT01306747|Behavioral|The Stanford Chronic Pain Self-Management Programme|The Stanford CPSMP is a patient education program consisting of six 2½ hour weekly sessions. Two trained instructors teach a group of 8-16 persons about managing pain.
16211186|NCT01306721|Drug|fexofenadine HCL (M016455)|Pharmaceutical form:tablet Route of administration: oral
16211187|NCT01306721|Drug|pseudoephedrine|"Pharmaceutical form:tablet
~Route of administration: oral"
16211188|NCT01306721|Drug|fexofenadine HCL matching placebo|"Pharmaceutical form:tablet
~Route of administration: oral"
16211189|NCT01306721|Drug|pseudoephedrine matching placebo|"Pharmaceutical form:tablet
~Route of administration: oral"
16211190|NCT01306708|Drug|amitriptyline|Nerve suprascapular blockade with local anaesthetic agent (novabupivacaine 0.25%, 10 ml, once per week) + oral tricyclic antidepressant (amitriptyline 25 mg, twice per day, for 14 days);
16211191|NCT01306695|Behavioral|New York University Caregiver Intervention (NYUCI)|"The NYU Caregiver Intervention (NYUCI) has substantial evidence of efficacy. This intervention is unique in its emphasis on family support and in providing ongoing availability of the counselor. While the NYUCI is being implemented in several communities, its effectiveness in the Hispanic community of Northern Manhattan has not been tested. The first component of the intervention consists of two individual and four family counseling sessions that include relatives suggested by the caregiver. The second component of the intervention is participation in a support group to provide the caregiver with continuous emotional support and education. The third component of the treatment is ad hoc counseling the continuous availability of counselors to caregivers and families to help them deal with crises and with the changing nature and severity of their relatives' symptoms over the course of the disease."
16211192|NCT01306695|Other|Community Health Worker (CHW) Case Management|The CHW intervention will consist of 2 visits in month 1, followed by monthly visits until month 6. The main role of the CHW will be to provide access to existing education and referral resources about dementia and caregiving. The CHW will carry a blackberry or iPhone type device with real time access to email, text, the internet, and telephone. Thus, the CHW will be able to provide participants with real time information from pertinent websites such as CUMC, Alianza, and the NY chapter of the Alzheimer's Association. CHW will also provide participants with their phone number and email address for ad-hoc contacts.
16211193|NCT01306682|Biological|Trivalent influenza vaccine|0.5 ml of trivalent influenza vaccine administered into deltoid muscle of non dominant arm
16211194|NCT01306682|Biological|Normal saline|0.5ml normal saline administered into deltoid muscle of non dominant arm
16211195|NCT01306669|Biological|Trivalent influenza vaccine|single dose of 0.5ml of Trivalent influenza vaccine for season will be administered into deltoid muscle of non-dominant arm
16211196|NCT01306669|Biological|Normal saline|Single dose of 0.5ml of normal saline will be administered into deltoid muscle of non-dominant arm
16211197|NCT01306656|Drug|10,000 IU Vitamin D3|"Month 1: 20,000 IU vitamin D3 once a week
~Months 2-6: 10,000 IU vitamin D3 once a week"
16211198|NCT01306656|Other|Placebo|"Month 1: Placebo once a week
~Months 2-6: Placebo once a week"
16211199|NCT01306656|Dietary Supplement|Vitamin D|Daily multivitamin with 400 IU vitamin D.
16211200|NCT01306643|Drug|Idelalisib|Tablet(s) administered orally twice daily
16211201|NCT01306630|Drug|tivozanib (AV-951) and capecitabine (Xeloda®)|Tivozanib 1.0 mg or 1.5 mg oral once daily for 2 weeks followed by 1 week off. Capecitabine 825 mg/m2, 1000 mg/m2, or 1250 mg/m2, oral twice daily for 2 weeks followed by 1 week off. 1 cycle= 3 weeks. Cycles will be repeated in the absence of disease progression or unacceptable toxicity.
16211202|NCT01306617|Drug|ABT-450|tablets
16211203|NCT01306617|Drug|ABT-333|tablets
16211204|NCT01306617|Drug|ribavirin|tablets
16211205|NCT01306617|Drug|ritonavir|capsules
16211206|NCT01306591|Drug|Bevacizumab 1|Bevacizumab, 1.25mg/0.05ml, every 6 weeks, 42weeks
16211207|NCT01306591|Drug|Bevacizumab|Bevacizumab, 1.25mg/0.05ml, 0week(baseline), 6week, 12week, 24week, 36week
16211208|NCT01306578|Drug|IVIG|Intravenous Immune Globulin at a dose 0f 0.4 g/kg/day for 5 consecutive days
16211209|NCT01306578|Procedure|Plasma Exchange|Five sessions of plasma exchange, single plasma volume each, for 5 consecutive days
16211210|NCT01306565|Drug|Low dose Atorvastatin|80mg atorvastatin followed by two 20mg daily atorvastatin
16211211|NCT01306565|Drug|High dose atorvastatin|80mg daily atorvastatin for 72 hours
16211212|NCT01306552|Behavioral|Student-Intervention only group|"One visit to the smoking prevention parcours offered by KARUNA e.V. (Rauchst Du noch oder lebst Du schon?) during 7th grade.
~The parcours takes approximately 3 hours to complete. The parcours consists of 7 interactive stations where a class of students learns about differences between smokers and non-smokers in terms of health status such as atherosclerosis prevalence, loss of smell or lung capacity and aging. Students also learn about the toxic ingredients in cigarettes. Each station includes a quiz to complete by each group of students. At the end of the parcours, a moderator will announce which group of students accumulated the most points. For more information on the contents of the parcours see http://www.karuna-prevents.de/index.php."
16211213|NCT01306552|Behavioral|Multi-component Intervention|"One visit to the smoking prevention parcours offered by KARUNA e.V. (Rauchst Du noch oder lebst Du schon?) + one parent night with information about smoking prevention and one informational letter by mail"
16211214|NCT01306552|Behavioral|Control Group|"One visit to the Nutrition and Physical Activity Parcours offered by KARUNA e.V. (Kinderleicht gesund zu leben).
~(same set up as the smoking prevention parcours with topics around healthy nutrition and promotion of physical activity)"
16211215|NCT01306539|Procedure|Stimulation of the subthalamic nucleus|Stimulation is delivered to the subthalamic nucleus at experimentally prescribed settings.
16211216|NCT01306513|Biological|autologous bone marrow derived mesenchymal stromal cells|Intravenous administration of autologous bone marrow-derived mesenchymal stromal cells.
16211324|NCT01305681|Device|LoFric® catheters during clean intermittent catheterization|LoFric® catheters during clean intermittent catheterization
16211217|NCT01306500|Procedure|Gastric lavage|8 Fr feeding tube was inserted orally with length equal to distance from the bridge of the nose to the earlobe and from the earlobe to a point halfway between the xiphoid process and the umbilicus. 20ml normal saline was used for gastric lavage. It was ensured that entire amount of normal saline used was removed from stomach.
16211218|NCT01306487|Procedure|Vitrectomy|Macular hole surgery
16211219|NCT01306461|Drug|Timolol and Tafluprost|"Preservative-free Timolol eye drops administered twice daily concomitantly with preservative-free Tafluprost eye drops administered once daily
~Treatment period 6 months"
16211220|NCT01306461|Drug|Fixed Dose Combination of tafluprost and timolol|"Preservative-free Fixed Dose Combination of tafluprost and timolol eye drops administered once daily.
~For masking purposes also: vehicle for timolol administered twice daily
~Treatment period 6 months"
16211221|NCT01306448|Device|Vibrant capsule|vibrating capsule
16211222|NCT01306435|Other|Laser|3-week treatment with three Laser sessions per week
16211223|NCT01306435|Other|Placebo Laser|3-week treatment with three Placebo Laser sessions per week
16211224|NCT01306422|Other|Hoodia gordonii purified extract (H.g.PE)|H.g.PE(1110 mg) formulated yogurt drink, twice-daily, 65 minutes before breakfast and dinner, for 15 days
16211225|NCT01306422|Other|Placebo yogurt drink|Placebo product (yogurt drink matching the H.g.PE extract formulated yogurt drink in nutritional composition and taste. Placebo is consumed twice-daily, 65 minutes before breakfast and dinner for 15 days.
16211226|NCT01306422|Other|Placebo yogurt drink|Placebo product, twice-daily for two days, 65 minutes before breakfast and lunch
16211227|NCT01306422|Other|Placebo yogurt drink|Placebo product, twice-daily for two days, 65 minutes before breakfast and dinner
16211228|NCT01306422|Other|Hoodia gordonii purified extract (H.g.PE)|H.g.PE formulated product (1110 mg), twice-daily for two days, 65 minutes before breakfast and lunch
16211229|NCT01306422|Other|Hoodia gordonii purified extract (H.g.PE)|H.g.PE formulated product (1110 mg), twice-daily for two days, 65 minutes before breakfast and dinner
16211230|NCT01306409|Drug|cera, darbepoetin, epoetin-beta|Epoetin once/ 2wk, cera once/ month, darbepoetin once/ 2wk
16211231|NCT01306409|Drug|ESA|Sequential application of three different ESA
16211232|NCT01306396|Behavioral|dietary intervention mainly focusing on fructose reduction|Based on the daily fructose intake assessed at the beginning of the study, children participating in the intervention group are advised to reduce their daily fructose intake by 50%. In the first study year, every three months and in the second study year, every six months, nutritional counseling is repeated in small groups in which parents and children are separately trained.
16211233|NCT01306383|Other|SODIS Bottle|SODIS Bottles used by SODIS group to treat their drinking water
16211234|NCT01306370|Drug|Tranexamic Acid|"Two dosage during the surgical intervention: the first dosage 15-30' before the leg ischemia and the second dosage at 60 -90' after the first dosage.
~Each dosage: 2 ampoules of 500mg/5 mL/ampoule"
16211235|NCT01306370|Drug|Fibrin glue|Topical administration, before to close the surgical wound. Dosage: 2 mL.
16211236|NCT01306370|Biological|Fibrin glue|Topical administration, before to close the surgical wound.
16211237|NCT01306370|Other|Habitual haemostasis|The surgical habitual haemostasis.
16211238|NCT01306357|Drug|Somatropin|4 mg or 10 mg delivered by needle-free device
16211239|NCT01306331|Drug|Conceptrol|• Conceptrol® Vaginal Gel, which contains 100 mg (4% concentration) of nonoxynol-9 (N-9) in 2.5 mL volume of gel.
16211240|NCT01306331|Drug|Amphora|• Amphora™ gel, which will be delivered in 5 mL doses, is a clear, water-based, petroleum-free gel.
16211241|NCT01306318|Drug|eperisone hydrochloride plus diclofenac sodium capsule|Single dose of fixed dose capsule formulation of eperisone hydrochloride 50 mg plus diclofenac sodium 50 mg to be given in healthy volunteers in fasting conditions
16211242|NCT01306318|Drug|eperisone hydrochloride tablet and diclofenac sodium tablet|Single dose of eperisone hydrochloride 50 mg as tablet formulation and diclofenac sodium 50 mg as tablet formulation to be given in healthy volunteers in fasting conditions
16211243|NCT01306305|Biological|Inflexal V|"Inflexal V influenza vaccine, formulated for the WHO requirements ofr the 2010-2011 season, containing per 0.5 mL dose:
~15 µg hemagglutinin (HA) antigen of A/California/7/2009 (H1N1)-like virus
~15 µg HA antigen of A/Perth/16/2009 (H3N2)-like virus
~15 µg HA antigen of B/Brisbane/60/2008-like virus
~Dose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Day 1"
16211244|NCT01306292|Drug|SonoVue|dose of 4.8 mL administered intravenously one time
16211245|NCT01306292|Drug|Placebo|Placebo is normal saline 0.9% for injection used as the comparator administered at 4.8 mL (same dose as SonoVue)
16211246|NCT01306266|Drug|Rizatriptan|initial treatment with Maxalt-MLT 10 mg followed by treatment with placebo. Drug is to be taken at onset of a moderate or severe headache
16211247|NCT01306266|Drug|Placebo|Initial treatment with placebo followed by treatment with Maxalt-MLT 10 mg at onset of a moderate or severe headache.
16211248|NCT01306253|Biological|Inflexal V|"Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose:
~15 µg hemagglutinin (HA) antigen of A/Brisbane/59/2007 (H1N1)-like virus
~15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus
~15 µg HA antigen of B/Brisbane/60/2008-like virus
~Dose: intramuscular administration (M. deltoides) of a single dose of 0.5 mL on Day 1"
16211249|NCT01306240|Procedure|Surfactant instillation|Intra-tracheal poractant alpha instillation after tracheal intubation
16211250|NCT01306240|Procedure|nCPAP|Nasal Continous Positive Airways Pressure (nCPAP). Positive End Expiratory Pressure (PEEP) is set between 4 to 6 cm H2O. FiO2 is adjusted for a target post-ductus arteriosus SpO2 between 92% and 96%.
16211251|NCT01306227|Drug|L-Thyroxine|Treatment with L-Thyroxine:7,5 µg/kg/day. Oral treatment (one drop =5µg) in the morning, once a day.
16211252|NCT01306227|Drug|water|Oral treatment with water. Equal number of drop of water as compared with the treatment arm (according to the body weight of the newborn) in the morning, once a day.
16211253|NCT01306214|Drug|Placebo|Placebo matching BI 10773 low dose
16211254|NCT01306214|Drug|Placebo|Placebo matching BI 10773 low dose
16211255|NCT01306214|Drug|Placebo|Placebo matching BI 10773 high dose
16211256|NCT01306214|Drug|Placebo|Placebo matching BI 10773 high dose
16211257|NCT01306214|Drug|BI 10773|BI 10773 low dose once daily
16211258|NCT01306214|Drug|BI 10773|BI 10773 high dose once daily
16211259|NCT01306188|Biological|Breast cancer cohort|"Blood samples must be made within 48 hours after the inclusion of the patient. Patients are treated according to the standards of the centre where they are supported. No follow-up is provided in this study.
~For each patient, the following analyses is performed:
~The analysis of TCR and BCR repertoire diversity,
~The phenotypic analysis of immune subpopulations,
~The analysis of the global lymphopenia or subpopulations T,
~The analyses by multiplex assay of a large panel of plasma cytokines and chemokines."
16211260|NCT01306188|Biological|Lung cancer cohort|"Blood samples must be made within 48 hours after the inclusion of the patient. Patients are treated according to the standards of the centre where they are supported. No follow-up is provided in this study.
~For each patient, the following analyses is performed:
~The analysis of TCR and BCR repertoire diversity,
~The phenotypic analysis of immune subpopulations,
~The analysis of the global lymphopenia or subpopulations T,
~The analyses by multiplex assay of a large panel of plasma cytokines and chemokines."
16211261|NCT01306175|Drug|Digoxin plus BI 10773|Digoxin 0.5 mg as single dose, BI 10773 medium dose once daily
16211262|NCT01306175|Drug|Digoxin|Digoxin 0.5 mg as single dose
16211263|NCT01306162|Drug|Dabigatran etexilate plus dronedarone|dabigatran etexilate 150 mg plus dronedarone 400 mg as single dose
16211264|NCT01306162|Drug|Dabigatran etexilate|150 mg as single dose
16211265|NCT01306162|Drug|Dabigatran etexilate plus dronedarone|dabigatran etexilate 150 mg plus dronedarone 400 mg as single dose (staggered administration)
16211266|NCT01306162|Drug|Dabigatran etexilate plus dronedarone|dabigatran etexilate 150 mg single dose plus dronedarone 400 mg bid
16211267|NCT01306162|Drug|Dabigatran etexilate plus dronedarone|dabigatran etexilate 150 mg single dose plus dronedarone 400 mg bid (staggered administration)
16211268|NCT01306136|Behavioral|Prolonged Exposure|15 psychotherapy sessions focused on helping clients overcome avoidance behaviors and emotionally process trauma-related memories
16211269|NCT01306136|Behavioral|Usual care|Per usual care, patients are referred to a mental health provider within the health care setting.
16211270|NCT01306123|Drug|Nascobal nasal spray (cyanocobalamin, USP)|Single intranasal administration
16211271|NCT01306123|Drug|Vitamin B12-ratiopharm N, injection solution|One single intramuscular administration
16211272|NCT01306097|Drug|Zinc Supplement|10mg daily for under 1 years old children and 20mg daily for above 1 years old children
16211273|NCT01306058|Drug|TRC 105|15 mg/kg intravenous (IV) every 2 weeks
16211274|NCT01306058|Drug|Sorafenib|400 mg twice a day (bid) continuously in a 28 days cycle
16211281|NCT01306032|Drug|ABT-888|PARP enzymes are critical for maintaining genomic stability by regulating a variety of DNA repair mechanisms. Individuals with deleterious mutations in the BRCA1 or BRCA2 tumor suppressor genes have an increased risk of developing breast and ovarian cancers due to impaired or defective DNA damage repair; these individuals have an increased susceptibility to DNA-damaging agents and PARP inhibitors. Inhibition of PARP inhibits the repair of DNA damage caused by alkylating agents such as cyclophosphamide. Metronomic cyclophosphamide has demonstrated efficacy in several tumor types. The PARP inhibitor ABT-888 has been shown to potentiate the action of cyclophosphamide in xenograft models. This combination is well tolerated in a Phase I study and showing promising activity.
16211282|NCT01306032|Drug|Cyclophosphamide|
16211286|NCT01306006|Biological|Providing measles vaccine for all children 9-35 months who have not yet received a routine measles vaccine|Normal measles vaccines licensed for distribution through the national EPI program
16211287|NCT01305993|Drug|SB injection|Infusion SBinjection of 21.87ml/m^2, IV route, 24times for 4 months
16211288|NCT01305980|Drug|SB injection|Infusion SBinjection of 21.87ml/m^2, IV route, 24times for 4 months
16211289|NCT01305967|Drug|SB injection|Infusion SBinjection of 21.87ml/m^2, Intravenous route, 16times for 2.5 months
16211290|NCT01305941|Drug|Everolimus|everolimus 5 mg PO daily as two 2.5-mg tablets
16211291|NCT01305941|Drug|Vinorelbine|vinorelbine 25 mg/m2 will be administered via IV infusion over 6-10 minutes weekly.
16211292|NCT01305941|Drug|Trastuzumab|2 mg/kg IV administered over 30 minutes weekly
16211293|NCT01305928|Other|Warm Hand-off|"Warm Hand-Off
~Staff brief intervention and warm hand-off (5 min):
~Assess withdrawal, need for medication change
~Describe warm hand-off process
~Provide 2-page flyer
~Perform call, leave room
~Notify patients' nurse patient is talking to quitline
~Quitline session (20 min):
~Collect minimum data set
~Explore thoughts/feelings toward quitting
~Provide medication education
~Build plan to stay quit
~Schedule next call
~Staff check-back (5 min):
~Ask patient how session went
~Ask if patient requests cessation medication script on discharge"
16211294|NCT01305928|Other|Fax|"Fax
~Staff standard in-patient session: (30 minutes):
~Assess withdrawal, need for medication change
~Conduct assessment of smoking history, interest in quitting
~Explore relevance, risks, rewards, and roadblocks (4Rs) related to smoking and quitting
~Provide 2-page flyer
~Provide medication education
~Build plan to stay quit
~Describe fax-referral process
~Ask if patient requests cessation medication script on discharge"
16211325|NCT01305655|Drug|Glucarpidase|Patients treated with Glucarpidase if the 24 hour levels of MTX is >250 µM, 36 hour levels >30 µM or 42 hours levels >10 µM together with a reduced kidney function will be compared with patients in just below the tricking values.
16211358|NCT01305395|Drug|Sirolimus|Will start sirolimus after they develop CAV by angiogram
16211295|NCT01305915|Behavioral|Getting Back on Track|The intervention, entitled Getting Back on Track, is two hours in duration and delivered by a multidisciplinary team representing nursing, radiation therapy, social work, rehabilitation services, and nutrition from the Breast Cancer Clinic at Princess Margaret Hospital. Relying on the content of the Getting Back on Track booklet, clinical experience and the principles of adult education, this team developed scripts for each component of the class.
16211296|NCT01305902|Behavioral|contingency management|Participants assigned to the experimental group will earn chances to win prizes if they have walked the recommended number of steps.
16211297|NCT01305889|Behavioral|problem solving therapy|12 weeks of weekly 45 minute sessions of problem solving therapy
16211298|NCT01305889|Drug|Sertraline|12 weeks of sertraline; 25 mg for one week, 50 mg for 3 weeks; then 100 mg/day for 4 weeks; then 150 mg/day for 4 weeks based on tolerability and response
16211299|NCT01305876|Behavioral|yoga intervention|yoga session 2 x week over 3-1/2 months
16211300|NCT01305863|Device|ASC coated ePTFE vascular graft|An ePTFE vascular graft in which the lumen of the graft has been coated with an autologous coating of adipose-derived stromal cells (ASC) prepared using an automated point-of-care processing instrument to facilitate isolation and concentration of autologous adipose-derived stromal cells and subsequent sodding of small-diameter vascular grafts.
16211301|NCT01305863|Device|Propaten graft|6 mm Gore PROPATEN® graft (heparin-coated ePTFE vascular graft, thin-walled removable-ring stretch)
16211302|NCT01305850|Drug|placebo|Patients in the control group will administer antihypertensive agents, except angiotensin converting enzyme inhibitors, angiotensin receptor blockers and spironolactone. Dosages are adjusted appropriately to achieve and maintain the target blood pressure of 130/80 mmHg
16211303|NCT01305850|Drug|Aliskiren|Patients with hypertension will take fixed-dose 150 mg aliskiren per day. Antihypertensive agents other than angiotensin converting enzyme inhibitors, angiotensin receptor blocker and spironolactone will be allowed and dosages are adjusted appropriately to achieve and maintain the target blood pressure of 130/80 mmHg
16211304|NCT01305850|Drug|Aliskiren plus Losartan|Patients with hypertension will take fixed-dose 150 mg aliskiren + 50 mg losartan per day. Antihypertensive agents other than angiotensin converting enzyme inhibitors, angiotensin receptor blockers and spironolactone will be allowed and dosages are adjusted appropriately to achieve and maintain the target blood pressure of 130/80 mmHg
16211305|NCT01305850|Drug|Enalapril plus Losartan|Patients with hypertension will take fixed-dose 20 mg enalapril + 50 mg losartan per day. Antihypertensive agents other than angiotensin converting enzyme inhibitors, angiotensin receptor blockers and spironolactone will be allowed and dosages are adjusted appropriately to achieve and maintain the target blood pressure of 130/80 mmHg
16211306|NCT01305837|Drug|methylprednisolone|500 mg of methylprednisolone taken in 3 days every month
16211307|NCT01305824|Drug|PRT-201|PRT-201 10 micrograms administered at the time of AVF creation.
16211308|NCT01305824|Drug|Placebo|Placebo administered at the time of AVF creation.
16211309|NCT01305824|Drug|PRT-201|PRT-201 30 micrograms administered at the time of AVF creation.
16211310|NCT01305811|Device|Acupuncture|Sterile insertive needles are applied by licensed, experienced practitioners.
16211311|NCT01305798|Other|Scheduling and Active Choice for Biometric Participation|The control group will be informed via e-mail of the window of dates during which they can take part in the on-site screening and will be given instructions for scheduling an appointment. The active choice and default option arm will be informed via e-mail of a preselected time and date for their screening, which we will have generated randomly. This group will be asked to accept the default time, schedule a different time, defer the scheduling decision, or decline to receive a screening by clicking the appropriate option in the email. The active choice only arm will be given the same information as the control group, but they will also be asked to make an appointment immediately, defer the scheduling decision, or decline to receive a screening.
16211312|NCT01305772|Drug|Panitumumab|Single dose Panitumumab 9mg/kg IV (in the vein) prior to definitive therapy (surgery or radiation therapy). Two additional doses of panitumumab 9mg/kg IV may be given at weeks 1 & 4 of RT alone or weeks 1 & 4 of cisplatin/RT if they tolerated first dose of panitumumab.
16211313|NCT01305772|Procedure|Surgery|Second biopsy was taken from surgical resection tissue (when possible obtained pre and post panitumumab biopsies from the same site).
16211314|NCT01305772|Procedure|Radiation Therapy|Radiation therapy was initiated within 8 weeks after surgery, or as soon as possible.
16211315|NCT01305746|Drug|A-623|High dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
16211316|NCT01305746|Drug|A-623|Low dose given subcutaneously once a week until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
16211317|NCT01305746|Drug|A-623|High dose given subcutaneously once every 4 weeks until A623 is approved for clinical use in SLE or the Sponsor discontinues the study
16211318|NCT01305733|Drug|The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline|The injectant mixture consists of 150 mg levobupivacaine mixed with 30 mg ketorolac and 0.5 mg adrenaline
16211319|NCT01305733|Other|saline injection|saline
16211320|NCT01305720|Device|near infrared spectroscopy: invos 5100|NIRS device used in this study, the optical field includes a volume of tissue approximately 2 cm deep to the surface probe with a 4-mm source-detector distance, and thus, organ-specific monitoring is feasible in small patients. With informed consent, the investigators applied NIRS probes to the forehead and abdomen for cerebral (rSO2C) and abdominal (rSO2P) regional oxygen saturation measurements.
16211321|NCT01305707|Device|C-ECT|"C-ECT will be administered through a Thrymatron System IV device (Somatics, LLC, ISO 13485:2003). Electrode placement will be bilateral and energy administered during consolidation treatment will be same used in the acute episode. C-ECT will be given weekly for the first month, fortnightly for the following two months and monthly during the next 6 months. A total of 14 C-ECT sessions will be given over 9 months of treatment.
~Pharmacotherapy will remain unchanged since the acute episode to the end of the study. Drugs will be obtained as usually from the National Health System and will be prescribed according to data sheet and it will have a duration of 15 months."
16211322|NCT01305707|Drug|PHARMACOTHERAPY|Pharmacotherapy will remain unchanged since the acute episode to the end of the study. Psychotropics will be obtained as usually from the National Health System and will be prescribed according to data sheet and will have a 15 month duration.
16211326|NCT01305642|Dietary Supplement|Individualized fortification of breast milk|"Lactose, fat and protein content will be measured prior to breast milk fortification.
~Subsequently, breast milk for preterm infants will individually fortified adjusted by using data from milk analysis."
16211327|NCT01305629|Behavioral|Spiritual Self-Schema Therapy|"The Spiritual Self Schema therapy (3S+) intervention will consist of a series of 12 one hour-long sessions delivered individually to participants over a four-month period. The 3S+ approach combines cognitive and behavioral therapy techniques with elements of non-theistic Buddhist philosophy to increase motivation for treatment adherence, alcohol and/or substance use reduction or abstinence and the prevention or reduction of HIV risk behaviors. 3S+ draws from self-regulation theory, self-schema theory, and self-discrepancy theory to assist participants in defining and perceiving their addict self, when their addict self is active, and its resulting negative affect state. 3S+ remediates the addict schema by proposing the construction of an alternate and competing schema: the spiritual self. This spiritual self schema is compatible with HIV self-care, alcohol and drug use reduction or abstinence, adherence to treatment, and a compassionate life."
16211328|NCT01305616|Procedure|Phacoemulsification with yellow-tinted intraocular lens|Phacoemulsification is a kind of cataract surgery using ultrasound machine. Yellow-tinted intraocular lens are a sort of lens with the ability to filter blue and ultraviolet spectrum of light (380-500 nanometer)
16211329|NCT01305616|Procedure|Phacoemulsification with yellow-tinted intraocular lens|Phacoemulsification is a kind of cataract surgery using ultrasound machine. Yellow-tinted intraocular lens are a sort of lens with the ability to filter blue and ultraviolet spectrum of light.
16211330|NCT01305603|Drug|Bupivacaine|On both sides of the abdomen 30 ml of bupivacaine 2.5 mg/ml will be injected. This is a total of 60 ml of bupivacaine 2.5 mg/ml.
16211331|NCT01305603|Procedure|Injection|Injection under ultrasound-guidance
16211332|NCT01305590|Other|Survey to Understand Medication Adherence among HIV Patients|"We want to better understand how this particular population would react to commitment devices designed to increase medication adherence. We will survey participants to see if they would prefer more commitment, in the form of a Take-Medication-Get-Paid plan; less commitment, in the form of an Attend-Clinic-Get-Paid plan; or if they would prefer to designate their own levels of commitment."
16211333|NCT01305577|Drug|Deoxycholic acid injection|
16211334|NCT01305577|Drug|Placebo|Phosphate buffered saline placebo for injection
16211335|NCT01305564|Device|Denali inferior vena cava filter|The Denali inferior vena cava filter is a mechanical filtration device consisting of two levels of filtration (upper arms, lower legs), a retrieval hook to allow for retrieval using a standard snare, cranial and caudal anchors, and penetration limiters. The Denali filter is made from a laser cut nitinol tube.
16211336|NCT01305551|Drug|Saxagliptin|Tablet, Oral, 5 mg, once on Day 1 only
16211337|NCT01305551|Drug|Metformin XR|Tablet, Oral, 500 mg, once on Day 1 only
16211338|NCT01305551|Drug|Saxagliptin/Metformin XR FDC|Tablet, Oral, 5/500 mg, once on Day 1 only
16211339|NCT01305538|Drug|BMS-954561|
16211340|NCT01305538|Drug|BMS-954561|
16211341|NCT01305538|Drug|Placebo|
16211342|NCT01305525|Device|St. Jude Medical Spinal Cord Stimulation Systems|Spinal cord stimulation
16211343|NCT01305512|Drug|SPARC1028|SPARC1028 administration as 30-minute intravenous infusion once a week for 3 weeks, followed by 1 week of rest
16211344|NCT01305499|Drug|Entinostat days 3, 10|Given orally on days 3, 10
16211345|NCT01305499|Drug|5AC|
16211346|NCT01305499|Drug|Entinostat days 10,17|Given orally on days 10, 17
16211347|NCT01305460|Drug|Azacitidine|"Treatment will consist of azacitidine 75mg/m2/d for 5 days every 14 days for 4 cycles.
~Patients achieving CR or PR will be then treated with 4 cycles of azacitidine 75mg/m2/d for 5 days every 21 days followed by cycles of azacitidine 75mg/m2/d for 7 days administered every 28 days (cycles 9 and beyond), to be continued until progression/relapse or toxicity arises.
~Patients not obtaining CR or PR after the initial 4 cycles of azacitidine-14 will continue to receive azacitidine 75mg/m2/d for 5 days every 14 days for 4 additional cycles (cycles 5 to 8). If they achieve CR, PR or HI after 8 cycles, they will then be treated with azacitidine 75mg/m2/d for 5 days every 21 days (cycles 9 to 12) and subsequently cycles of azacitidine 75mg/m2/d for 7 days administered every 28 days (cycles 13 and beyond) until progression/relapse or toxicity arises.
~Patients not obtaining CR, PR or HI after 8 cycles of azacitidine-14 will go off-study."
16211348|NCT01305447|Behavioral|Exercise Behaviour Maintenance|Following the termination of the 14 week exercise aided smoking cessation program, trained exercise facilitators will deliver 15 minute biweekly (for the first month), monthly (for the next 2 months), and then bimonthly (for last 8 months) phone calls to remind the participants of the self-regulatory skills they learned during group discussion.
16211349|NCT01305447|Behavioral|Smoking Relapse prevention booklets|Participants will be given Brandon et al. (2000, 2004) smoking relapse prevention booklets following exercise program.
16211350|NCT01305447|Behavioral|Contact control|No treatment, but equal contact time as the other intervention arms. Topics of women's health, unrelated to exercise will be discussed in group-mediated sessions(control).
16211351|NCT01305434|Dietary Supplement|Mulberry leaf extract effect on post prandial blood glucose|"Mulberry leaf extract (400 mg, Mulberry Zuccarin, New Nordic) or placebo will be administered with meals to type 2 diabetics. Half the patients will receive mulberry leaf extract for the first two weeks and half will receive placebo. Following a one week wash out period, the interventions will be reversed for another 2 weeks, followed by a final wash out period. Subjects will keep diaries of food, exercise, daily fasting glucose, and at least one 2 hour pc glucose per day for the 6 weeks of the trial.
~Baseline renal function blood work and urine, liver function blood work, hemoglobin A1C, weight, and blood pressure will be done. These will be repeated at the end of each subject's 6 weeks in the trial. In addition, blood pressure will be checked with the distribution of the each 2 week batch of medications."
16211352|NCT01305421|Procedure|grip test|Muscle strength measurement by hand-held dynamometer
16211353|NCT01305408|Drug|Armodafinil|Armodafinil tablets, taken orally, once daily in the morning
16211354|NCT01305408|Drug|Placebo|Matching placebo tablets, taken orally, once daily in the morning
16211355|NCT01305395|Drug|Sirolimus|Will initiate sirolimus within 6 months of heart transplant
16211356|NCT01305395|Drug|Sirolimus|Will start sirolimus after CAV has been diagnosed by angiogram
16211357|NCT01305395|Drug|Sirolimus|Will start sirolimus after CAV has been diagnosed by intravascular ultrasound
16211359|NCT01305395|Drug|Sirolimus|Will start sirolimus after CAV has been diagnosed by intravascular ultrasound
16211360|NCT01305369|Drug|Prasugrel|"Patients will be blindly and randomly allocated to treatment A (prasugrel 10 mg daily) or B (placebo) for 15 days. After a 15-day wash-out period, patients who had initially been allocated to treatment A will be allocated to treatment B, and vice versa."
16211361|NCT01305356|Device|Augment® Injectable Bone Graft|Implantation of up to 9cc of Augment® Injectable Bone Graft
16211362|NCT01305356|Procedure|Autologous bone graft|Implantation of up to 9cc of autologous bone graft
16211363|NCT01305343|Procedure|Routinely performed surgical correction of spinal deformity|Routinely performed surgical correction of spinal deformity
16211364|NCT01305317|Drug|Lipitor|Atorvastatin 20mg daily for 6 months
16211365|NCT01305304|Other|repeated long term endurance exercise|competitive running at a national level during a period of at least 5 years (i.e. approximately 50km per week over more than 10 years)
16211366|NCT01305304|Other|Other|No history of endurance sports activity
16211367|NCT01305291|Other|placebo|
16211368|NCT01305291|Dietary Supplement|digestion-resistant maltodextrin|
16211369|NCT01305278|Other|Use of Nintendo Wii Balance Gaming system|Use of Nintendo Wii Balance Gaming system
16211370|NCT01305265|Device|cuff manometer|endotracheal tube cuff will be inflated to 22-26 cm H20 using cuff manometer
16211371|NCT01305252|Drug|treprostinil inhalations|Treprostinil inhalation QID starting at 3 breaths per inhalation & gradually increasing to 9 breaths. Each breath provides approximately 6mcg of treprostinil.
16211372|NCT01305252|Drug|tadalafil|tadalafil 20mg QD PO increasing to 40mg QD as tolerated
16211373|NCT01305239|Drug|Aromasin|Aromasin 25 mg daily.
16211374|NCT01305226|Drug|THR-100|THR-100: 15 mg double-bolus (15mg/15ml), separated by 30 minutes (total 30 mg)
16211375|NCT01305226|Drug|Streptokinase|Streptokinase: Standard regimen (1.5 million IU) is made up in 150 ml of physiological saline or glucose solution and administered intravenously over a period of 60 minutes.
16211376|NCT01305213|Biological|Bevacizumab|Given IV
16211377|NCT01305213|Drug|Fosbretabulin Tromethamine|Given IV
16211378|NCT01305213|Other|Laboratory Biomarker Analysis|Correlative studies
16211379|NCT01305200|Drug|supersaturated calcium phosphate rinse|Mouth rinse
16211380|NCT01305200|Other|placebo|Mouth rinse
16211381|NCT01305200|Other|questionnaire administration|Ancillary studies
16211382|NCT01305200|Procedure|quality-of-life assessment|Ancillary studies
16211383|NCT01305187|Device|Hyaluronic Acid Filler|The dosage is individualized depending on the depth of the NLF. The goal is to achieve optimal correction of both NLF with single implantations of Belotero® Basic and Juvéderm® Ultra 3 respectively. Each subject will be injected with Belotero® Basic and Lidocaine containing Juvéderm® Ultra 3 according to a split-face design. The allocation of fillers to the side of the face will be randomized. The randomization method is block-wise with a ratio 1:1 to the groups Belotero® Basic left and Juvéderm® Ultra 3 right, Belotero® Basic right and Juvéderm® Ultra 3 left.
16211384|NCT01305174|Device|PROTEGE GPS stent vs. VISI-PRO stent|Visi-Pro balloon expandable stent vs. PROTEGE GPS selfexpanding nitinol stent to treat stenosis or occlusion of common and external iliac artery disease
16211385|NCT01305161|Other|Blood simple|Single Blood simple at Day 1
16211386|NCT01305148|Device|Warfarin GenoSTAT Test|Use of genetic information from the GenoSTAT test to determine the warfarin dose
16211387|NCT01305135|Drug|azacitidine and idarubicin|azacitidine:100mg, 75mg/m²/d, during 7days every 28 days (D1-D7). Idarubicin: 5mg/ml, 5mg/m²/d (palier1) or 10mg/m²/d (palier2), D8
16211388|NCT01305122|Behavioral|neurocognitive tests|"inclusion
~1 year
~3 years
~5 years"
16211389|NCT01305109|Biological|ORV 116E|Oral Rotavirus Vaccine 116E (ORV 116E), 10^5.0 FFU of Bharat Biotech International Limited, 3 doses of 0.5mL at 4 week intervals
16211390|NCT01305109|Biological|Placebo|3 doses of 0.5 mL at 4 week intervals
16211391|NCT01305096|Other|Yoga intervention|6 weeks of yoga postures, once a week for 60 minutes in a group session with a yoga teacher.
16211392|NCT01305083|Drug|Udenafil|Placebo-control
16211393|NCT01305083|Drug|Placebo|Placebo
16211394|NCT01305070|Device|Admiral Xtreme|For balloon angioplasty of in-stent restenosis in the superficial femoral artery
16211395|NCT01305070|Device|In.Pact Admiral|For balloon angioplasty of in-stent restenosis in the superficial femoral artery
16211396|NCT01305057|Other|Pyridoxine tri-isopalmitate|2% dosage, oil-in-water emulsion, twice a day, 28 days
16211397|NCT01305044|Behavioral|Tai Chi Chih|Tai Chi Chih (TCC), a westernized and manualized form of the ancient TC Chuan, consists of a series of 20 simple, repetitive, non-strenuous movements that involve no physical contact and emphasize a soft, flowing continuity of motion. This form of meditation through movement consists of a standardized protocol that emphasizes slow, fluid, continuous forms that integrate mental concentration, awareness, balance, shifting of body weight, gentle movement, imagery, muscle relaxation and breathing control. TCC was developed for use with elderly persons.
16211398|NCT01305044|Behavioral|Health Education Classes|The Health Education classes serve as an attention control group, are led by gerontology specialists, physicians, and other health professionals, and focus on topics that are relevant to elderly cancer survivors.
16211399|NCT01305031|Other|Resuscitation|Use of inspiratory fraction of oxygen needed to achieve oxygen saturation in the preset limits 85-92%
16211400|NCT01305031|Other|100% oxygen|Use of 100% oxygen needed to achieve oxygen saturation in the preset limits 85-92%
16211401|NCT01305018|Dietary Supplement|BCAA|7 g of leucine + 3,5 g of isoleucine + 3,5 g of valine per day during 9 days
16211402|NCT01305018|Dietary Supplement|Leucine|7 g of leucine + 7 g of alanine per day during 9 days
16211403|NCT01305018|Dietary Supplement|Placebo|14 g of alanine per day during 9 days
16211404|NCT01304992|Dietary Supplement|Protein drink - low dosage|The subjects will consume 500 mL of a protein drink containing 25 g protein (lupin protein or reference protein) per day over eight weeks each. After a one-week run-in period, each volunteer has to pass both protein-periods in different order with a four-week wash out period in between.
16211432|NCT01304797|Drug|MM-302 Monotherapy|Escalating doses of MM-302 as a single agent
16211517|NCT01304121|Device|Bioactive glass (SP53P4)|Commercial resorbable bone graft substitute (Vioxid Ltd)
16211405|NCT01304992|Dietary Supplement|Protein drink - high dosage|The subjects will consume 500 mL of a protein drink containing 40 g protein (lupin protein or reference protein) per day over eight weeks each. After a one-week run-in period, each volunteer has to pass both protein-periods in different order with a four-week wash out period in between.
16211406|NCT01304979|Procedure|Acupuncture therapies|Acupuncture therapies combined in treatment: application of ear seeds; acupuncture; and acupuncture with gua sha treatment designed to relieve pain and facilitate recovery.
16211407|NCT01304979|Procedure|Control|Indirect therapies that mimic direct therapy intervention
16211408|NCT01304966|Procedure|biopsy|excisional biopsy
16211409|NCT01304953|Drug|Group P+P|"In this arm, anaesthesia was maintained with propofol and remifentanil (0.1 μg kg-1 min-1), and primary anaesthetic namely propofol was titrated to maintain intraoperative BIS values between 45 and 55. If the patient did not respond to increases in the level of primary anaesthetic, additional doses of remifentanil up to 0.2 μg kg-1 min-1 were permitted to provide a more cardio-stable anaesthesia.
~Patients in this arms received saline placebo i.v. after the induction of anaesthesia."
16211410|NCT01304953|Drug|Group P+T|"In this arm, anaesthesia was maintained with propofol and remifentanil (0.1 μg kg-1 min-1), and primary anaesthetic namely propofol was titrated to maintain intraoperative BIS values between 45 and 55. If the patient did not respond to increases in the level of primary anaesthetic, additional doses of remifentanil up to 0.2 μg kg-1 min-1 were permitted to provide a more cardio-stable anaesthesia.
~Patients in this arms received tropisetron 2 mg i.v. after the induction of anaesthesia."
16211411|NCT01304953|Drug|Group S+P|"In this arm, anesthesia was maintained by sevoflurane and remifentanil (0.1 μg kg-1 min-1), and primary anaesthetic namely sevoflurane was titrated to maintain intraoperative BIS values between 45 and 55. If the patient did not respond to increases in the level of primary anaesthetic, additional doses of remifentanil up to 0.2 μg kg-1 min-1 were permitted to provide a more cardio-stable anaesthesia.
~Patients in this arms received saline placebo i.v. after the induction of anaesthesia."
16211412|NCT01304953|Drug|Group S+T|"In this arm, anesthesia was maintained by sevoflurane and remifentanil (0.1 μg kg-1 min-1), and primary anaesthetic namely sevoflurane was titrated to maintain intraoperative BIS values between 45 and 55. If the patient did not respond to increases in the level of primary anaesthetic, additional doses of remifentanil up to 0.2 μg kg-1 min-1 were permitted to provide a more cardio-stable anaesthesia.
~Patients in this arms received tropisetron 2 mg i.v. after the induction of anaesthesia."
16211413|NCT01304927|Drug|Cholecalciferol and calcium|Initial one dose oral mixture of 300.000 IU Cholecalciferol followed by 5 months treatment with one tablet daily containing 35 ug Cholecalciferol and 500 mg calcium
16211414|NCT01304927|Other|Placebo|microcrystalline cellulose maltodextrin Arachidis oil
16211415|NCT01304901|Drug|montelukast 4 mg granule|Children had received single dose of 4 mg oral montelukast after first dose of nebulized salbutamol and systemic glucocorticoids.
16211416|NCT01304901|Drug|Montelukast placebo granüle|Children had received single dose of oral placebo montelukast granule after first dose of nebulized salbutamol and systemic glucocorticoids.
16211417|NCT01304888|Other|Cash + nutrition education|Cash transfer of 150 Mexican pesos (equivalent to approximately 14 USD at the time) per month. The size of the cash transfer and the amount of food was the same for all households, i.e. no adjustments for family size or composition were made. Households received the transfer once every 2 mo. Beneficiary households were required to attend nutrition and health education sessions and had to participate in program related logistic activities in order to receive the benefits. These program conditionalities, however, were not strictly enforced.
16211418|NCT01304888|Other|Food basket + nutrition education|Monthly food basket with a cost to the program of 150 pesos. The amount of food was the same for all households, i.e. no adjustments for family size or composition were made. The basket contained a number of staple and basic food products and powdered whole milk (Liconsa), which is fortified with Zn, Fe, Vitamin C, and folate. The composition of the food basket conformed to the Mexican norm for food aid programs (NOM-169-SSA1-1998). Households received the transfer once every 2 mo. Beneficiary households were required to attend nutrition and health education sessions and had to participate in program related logistic activities in order to receive the benefits. These program conditionalities, however, were not strictly enforced.
16211419|NCT01304888|Other|Food basket w/o nutrition education|A monthly food basket with a cost to the program of 150 pesos. The amount of food was the same for all households, i.e. no adjustments for family size or composition were made. The basket contained a number of staple and basic food products and powdered whole milk (Liconsa), which is fortified with Zn, Fe, Vitamin C, and folate. The composition of the food basket conformed to the Mexican norm for food aid programs (NOM-169-SSA1-1998). Households received the transfer once every 2 mo. Beneficiary households were not required to attend nutrition and health education sessions.
16211420|NCT01304888|Other|Control|No benefits were provided
16211421|NCT01304862|Behavioral|eSMART-MH intervention|Involves simulated interactions between participants and the virtual health care providers (avatars).
16211422|NCT01304862|Behavioral|Educational videos about healthy living|20 minute screen-based educational videos on topics about healthy living--nutrition, physical activity, and sleep hygiene.
16211423|NCT01304849|Drug|Escalated BEACOPP|"Escalated BEACOPP chemotherapy will be delivered for those patients who are interim PET CT positive after 2 cycles of ABVD chemotherapy. The patients will receive 2-4 cycles of Escalated BEACOPP once in 3 weeks. The cycles will be delivered as follows:
~Bleomycin 10mg/m2 IV in day 8, Etoposide 200mg/m2 Day 1 to Day 3, Adriamycin 35mg/m2 on Day 1 IV, Cyclophosphamide 1200mg/m2 on Day 1 IV, Vincristine 1.4mg/m2 on Day 8 IV, Cap Procarbazine 100mg/m2 Day 1 to Day 7 PO, T Prednisolone 40mg D1-D7 of a 21 day cycle. With Inj Mesna 400mg/m2 0, 4 and 8 hours on the day of Cyclophosphamide Inj G-CSF will be started routinely from Day 9 till recovery of Absolute neutrophil counts ≥5000/cmm or Total WBC counts≥ 8000/cmm"
16211424|NCT01304836|Drug|Advagraf|oral
16211425|NCT01304836|Drug|Mycophenolate Mofetil|oral
16211426|NCT01304836|Drug|Simulect|IV
16211427|NCT01304836|Drug|Corticosteroids|IV & oral
16211428|NCT01304823|Dietary Supplement|lactisole|flavoring agent/sweet taste antagonist
16211429|NCT01304823|Other|mixed liquid meal|Ensure Plus
16211430|NCT01304810|Biological|NicVAX vaccine|Prior treatment with NicVAX in Nabi-4514 or Nabi-4515. No intervention in Nabi-4522.
16211431|NCT01304810|Biological|Placebo|Prior treatment with Placebo in Nabi-4514 or Nabi-4515. No intervention in Nabi-4522.
16211433|NCT01304797|Drug|MM-302 in combination with trastuzumab|Escalating MM-302 at an every 4 week dosing schedule, while the dose of trastuzumab is fixed at an every 2 week dosing schedule
16211434|NCT01304797|Drug|MM-302 in combination with trastuzumab q3w|Escalating MM-302 at an every 3 week dosing schedule, while the dose of trastuzumab is fixed at an every 3 week dosing schedule
16211435|NCT01304797|Drug|MM-302 in combination with trastuzumab and cyclophosphamide|Escalating MM-302 at an every 3 week dosing schedule, while the dose of trastuzumab and cyclophosphamide is fixed at an every 3 week dosing schedule
16211436|NCT01304784|Drug|Cisplatin, Capecitabine, Trastuzumab and MM-111|Conventional chemotherapy
16211437|NCT01304784|Drug|Lapatinib +/- Trastuzumab and MM-111|Conventional chemotherapy
16211438|NCT01304784|Drug|Paclitaxel, Trastuzumab and MM-111|Conventional chemotherapy
16211439|NCT01304784|Drug|Lapatinib, trastuzumab, paclitaxel, and MM-111|Conventional chemo
16211440|NCT01304784|Drug|Docetaxel, trastuzumab and MM-111|Conventional chemotherapy
16211441|NCT01304771|Biological|Synbiotic AKSB|AKSB is a novel synbiotic that contains a probiotic bacterium (Enterococcus faecium, microencapsulated SF68 or Ventrux ME 30), a probiotic yeast (Saccharomyces cerevisiae, Lynside® Pro-Lay 1), and a prebiotic (fructo-oligosaccharide [FOS], NutraFlora®).
16211442|NCT01304758|Device|ExAblate Transcranial MRgFUS System|Treatment with the ExAblate Transcranial MRgFUS System.
16211443|NCT01304745|Behavioral|Physical training in group|Physical training in group, 6-9 participants, two times av week (1.5 hours) over a period of 16 weeks, focusing on strength and endurance training including body awareness and relaxation.
16211444|NCT01304745|Behavioral|Educational and counseling in group|Educational and counseling groups with 6-9 participants, with seven group meetings 2.5 hours over a period of seven weeks. Each session starts with a (20 minutes) lecture were one out of seven different topics are presented (Fatigue, sexuality, coping and coping strategies, etc).
16211445|NCT01304719|Behavioral|Computer Assisted Healthy Families America Home Visitation|Computer modules added to home visitation protocol for Healthy Families America
16211446|NCT01304719|Behavioral|Healthy Families America Home Visitation|Healthy Families America Home Visitation Treatment as Usual
16211447|NCT01304706|Drug|Fluocinolone Acetonide|0.2 μg/day
16211448|NCT01304693|Biological|ESBA1008 solution|Administered as a single intravitreal injection (Dose A, Dose B, Dose C, Dose D)
16211449|NCT01304693|Biological|Ranibizumab 0.5 mg|Administered as a single intravitreal injection
16211450|NCT01304641|Other|Atorvastatin Initiators|Retrospective database analysis no intervention performed.
16211451|NCT01304641|Other|Simvastatin Initiators|Retrospective database analysis no intervention performed.
16211452|NCT01304628|Drug|PL-3994|subcutaneous PL-3994, single dose, 4 escalating dose groups
16211453|NCT01304615|Behavioral|Decrease Energy Density of the Diet|Participants will be given goals to help guide their food choices to decrease the energy density of the overall diet. The goals are to eat 10 or more foods with an ED less than 1.0 and 2 or less foods with an ED of great than 3.0 each day and to reduce portion sizes.
16211454|NCT01304615|Behavioral|Increase Steps per Day|Participants will increase their steps per day by at least 3,000 steps per day above their baseline levels.
16211455|NCT01304615|Behavioral|Consumption of Self-made Meals|Participants will have the goal of increasing the number of self-prepared meals that they consume to 10 or more lunch and dinner meals each week.
16211456|NCT01304602|Drug|Irinotecan|IV over 90 minutes on day 1 of each cycle (every 2 weeks) at the cohort assigned dose level
16211457|NCT01304602|Drug|BKM120|BKM120, oral, daily starting with cycle 1/day 2 at the cohort defined dose level
16211458|NCT01304589|Drug|Milnacipran|6-week titration period starting at 12.5mg daily and moving up to 200mg daily (or maximum tolerated dose) for 12 weeks - total treatment period is 18 weeks
16211459|NCT01304576|Behavioral|Neuropsychological testing|Experimental test about orientation agnosia and standard neuropsychological tests.
16211460|NCT01304576|Other|MRI|Cerebral MRI
16211461|NCT01304563|Biological|TIV 2010/2011 influenza vaccine|TIV 2010/2011 influenza vaccine Intramuscular: 15 mcg TIV 2010/2011 vaccine x 1: Control
16211462|NCT01304563|Biological|TIV 2010/2011 influenza vaccine|Low dose TIV 2010/2011 influenza vaccine delivered via intradermal injection x 1: Experimental
16211463|NCT01304563|Biological|TIV 2010/2011 influenza vaccine|Higher lower dose TIV 2010/2011 influenza vaccine delivered via intradermal injection x 1: Experimental
16211464|NCT01304563|Biological|INT|Low dose TIV 2010/2011 influenza vaccine delivered via a short needle intradermal device x 1: Experimental
16211465|NCT01304537|Drug|Alpha-1 Antitrypsin 40mg (AAT, Glassia®)|Each study group will undergo 3 treatment periods:12 weeks, 8 weeks and 4 weeks.
16211466|NCT01304537|Drug|Alpha-1 Antitrypsin 60mg (AAT, Glassia®)|Each study group will undergo 3 treatment periods:12 weeks, 8 weeks and 4 weeks.
16211467|NCT01304537|Drug|Alpha-1 Antitrypsin 80mg (AAT, Glassia®)|Each study group will undergo 3 treatment periods:12 weeks, 8 weeks and 4 weeks.
16211468|NCT01304524|Biological|VGX 3100|1ml of VGX-3100 delivered IM followed by electroporation at Day 0, Week 4 and Week 12.
16211469|NCT01304524|Biological|Placebo|1ml of placebo delivered IM followed by electroporation at Day 0, Week 4 and Week 12.
16211470|NCT01304524|Device|CELLECTRA™-5P|CELLECTRA™-5P is used for electroporation following IM delivery of VGX 3100 or placebo on Day 0, Week 4 and Week 12.
16211471|NCT01304511|Drug|Orgalutran|
16211472|NCT01304498|Biological|V503|9-valent HPV [Types 6, 11, 16, 18, 31, 33, 45, 52, and 58] L1 virus-like particle vaccine
16211473|NCT01304498|Biological|GARDASIL|Quadrivalent HPV [Types 6, 11, 16, and 18] L1 virus-like particle vaccine
16211474|NCT01304485|Drug|Sodium Acetate C11|PET Imaging with Sodium Acetate C11
16211475|NCT01304472|Drug|Prasugrel|Prasugrel 10mg per day
16211476|NCT01304472|Drug|Clopidogrel|Clopidogrel 150mg per day
16211513|NCT01304147|Drug|Ketamine|A single dose of intranasal ketamine up to 50 mg
16211514|NCT01304147|Drug|placebo|Single dose of saline intranasal
16211515|NCT01304134|Drug|Oxycodone|dosage:10mg/l dosage form:injection frequency:via PCA pump, background rate:0.5ml/h, 2ml/time duration:48 hours
16211516|NCT01304134|Drug|Morphine|dosage: 10mg/ml dosage form: injection frequency: via PCA pump, background rate: 0.5ml/h, 2ml/times duration: 48 hours
16214048|NCT01284517|Drug|Placebo|Equivalent to Lurasidone dosing
16211477|NCT01304446|Dietary Supplement|industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren|The oral and tube supplement offered was Nutren Jr® (for patients aged 1 - 9 years) or Nutren 1.0- Nestlé Clinical Nutrition-Brazil (for those aged 10 years or over). This supplement was a whole powder formulation that presented a macro composition of 52% carbohydrates, 12% proteins and 36% lipids. Its vitamins were A, D, E, K, B complex, biotin and choline; its trace elements were iron, copper, zinc, manganese, selenium, chromium and molybdenum; its macroelements were potassium, calcium, sodium, chlorine, iodine, magnesium and phosphorus; and it contained taurine and L-carnitine presenting 1.0 kcal/ml.
16211478|NCT01304433|Drug|Venofundin 6% / Tetraspan 6%|Venofundin 6% / Tetraspan 6%
16211479|NCT01304420|Device|Ultrasonography|Scanning 5 joints bilaterally with an ultrasound scanner
16211480|NCT01304407|Other|Calcium stable isotope|Subjects consume breakfast and 180 ml of calcium-fortified orange juice to which 20 mg of 46Ca stable isotope was added. Immediately after breakfast, subjects receive 5 mg of 42Ca intravenously.
16211481|NCT01304394|Drug|Ped3CB|The Ped3CB is a ready to use, triple-chamber bag containing a sterile, nonpyrogenic combination of amino acids (Primene®, Baxter) with electrolytes, glucose, and lipids (ClinOleic®, Baxter) in separate compartments for intravenous (IV) PN. The dosage, frequency and duration is dependent on patient's weight, age, clinical status as well as addition energy or protein given enterally/orally.
16211482|NCT01304381|Other|Integrated care|Intervention Multidisciplinary approach and collaboration between specialist palliative and heart failure caregivers, in a shared structured person-centred and identity-promoting care during 6 months
16211483|NCT01304381|Other|Integrated care|One group with 31 participants is offered a multidisciplinary approach and collaboration between specialist palliative and heart failure caregivers in a shared structured person-centred care at home. Assessment of need, length of visits and phone calls are planned to be adapted for each patient. After 6 months (+ - two weeks) the patients will be transferred to usual care provider following an established individual care plan.
16211484|NCT01304368|Procedure|Thermotherapy|Patients are instructed to heat a moor mud filled heat pad (beinio®therm, bb med. product GmbH, Kalkar (Kehrum), Germany) to a hot, but tolerable temperature and to apply it over the painful area once a day for 20 minutes during a period of 14 days. Patients are instructed to continue their usual medication - including analgesic drugs - and physiotherapy (massages and exercise) during the study period.
16211485|NCT01304342|Drug|Remifentanil|1 microgram/kg/h, continuous infusion, 5 min before and during the ERCP
16211486|NCT01304342|Drug|Fentanyl|Intranasal fentanyl 200 micrograms 5 min before the ERCP
16211487|NCT01304342|Drug|Normal saline|Normal saline intravenously and intranasally
16211488|NCT01304329|Drug|BI 10773|Medium dose oral administration
16211489|NCT01304329|Drug|simvastatin|Medium dose oral administration
16211490|NCT01304329|Drug|simvastatin|Medium dose oral administration
16211491|NCT01304329|Drug|BI 10773|Medium dose oral administration
16211492|NCT01304316|Drug|Tetracaine HCl 3% and Oxymetazoline HCl 0.05%|Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
16211493|NCT01304303|Drug|SPARC1023 I|IV administration
16211494|NCT01304303|Drug|SPARC1023 II|IV administration
16211495|NCT01304290|Other|Hyperinsulinemic/normoglycemic clamp|"Dextrose/insulin therapy will start. Dextrose and insulin are given using the so-called normoglycemic, hyperinsulinemic clamp. Plasma insulin concentration will be increased by a 2ìU/kg/min continuous infusion of insulin. Dextrose will be infused at the rate required to maintain normoglycemia (4-6 mmol/l) until cross clamping of the aorta. The dextrose/insulin therapy will be maintained for a time period of minimum 6 hours."
16211496|NCT01304277|Biological|agalsidase alfa|
16211497|NCT01304264|Device|Color Doppler Imaging|Color Doppler imaging (CDI) system for measurements of blood flow in the ophthalmic (OA), central retinal (CRA), and nasal (NPCA) and temporal (TPCA) posterior ciliary arteries. In each vessel, peak systolic velocity (PSV) and end diastolic velocity (EDV) were determined, and Pourcelot's resistive index will be calculated (RI = (PSV-EDV)/PSV).
16211498|NCT01304251|Other|Short-term fasting|Short-term fasting, i.e. 24 hours before and 24 hours after administration of chemotherapy
16211499|NCT01304251|Other|Healthy nutrition|Eating according to the current guidelines for healthy nutrition as from 24 hours before until 24 hours after the beginning of administration of chemotherapy. Dietary instructions will be given by a dietician and actual food intake will be recorded in a journal.
16211500|NCT01304238|Drug|lepirudin|lepirudin
16211501|NCT01304238|Drug|danaparoid|danaparoid
16211502|NCT01304238|Drug|argatroban|argatroban
16211503|NCT01304238|Drug|fondaparinux|fondaparinux
16211504|NCT01304225|Procedure|Panretinal photocoagulation|Panretinal photocoagulation utilizing 100ms pulse duration, moderate intensity burns, in a single-shot fashion
16211505|NCT01304225|Procedure|Panretinal photocoagulation|Panretinal photocoagulation utilizing 20ms pulse duration, moderate intensity burns, in a multiple-shot fashion
16211506|NCT01304225|Procedure|Panretinal photocoagulation|Panretinal photocoagulation utilizing 20ms pulse duration, barely visible intensity burns, in a multiple-shot fashion
16211507|NCT01304212|Drug|several drugs: morphine chloride,ropivacaine,epinephrine,ketorolac|This technique is performed intraoperatively with a 100 ml solution containing: 225 mg of ropivacaine 1% (22.5 ml) + 5 mg of morphine chloride 0.1% (5ml) + 30 mg of epinephrine 1:1000 (0.3 ml ) + ketorolac 30mg (1ml) +71 ml of 0.9% saline
16211508|NCT01304212|Drug|ropivacaine,morphine chloride,epinephrine,ketorolac|This technique is performed intraoperatively with a 100 ml solution containing: 225 mg of ropivacaine 1% (22.5 ml) + 5 mg of morphine chloride 0.1% (5ml) + 30 mg of epinephrine 1:1000 (0.3 ml ) + ketorolac 30mg (1ml) +71 ml of 0.9% saline
16211509|NCT01304212|Drug|ropivacaine|The lock is held before starting the operation, viewing with ultrasound and confirmed the femoral nerve with nerve stimulation at an intensity of 0.5 mA and a frequency of 2 Hz Pajunk 50mm needle, patellar flexion. It be administered 30ml of ropivacaine 0.75% (225mg)
16211510|NCT01304212|Drug|morphine ,ketorolac|ultrasound-assisted femoral nerve block is performed and leaks intraoperatively with a 100 ml solution containing: 5 mg of morphine to 0.1% (5ml) +30 mg of ketorolac (1 ml) +96 ml of 0.9% saline.
16211511|NCT01304186|Behavioral|Tailored Information|The intervention comprises a computer-based application designed to provide individually-tailored information to participants in an interactive fashion.
16211512|NCT01304160|Radiation|stereotactic body radiotherapy|30Gray in 5 fractions
16211518|NCT01304108|Other|VTE-P Tollgate|Add VTE-P tollgate order set that requires a decision regarding VTE-P for every patient admitted or transferred in our hospital system
16211519|NCT01304108|Other|BLAZE Pop up|Develop and deploy a rules-based popup that reminds prescribers interfacing with the orders system when a patient does not have an active VTE-P plan.
16211520|NCT01304108|Other|Usual Care|No addition to the baseline system for care
16211521|NCT01304095|Drug|Ranolazine|Patients in the ranolazine arm would start with 500 mg po BID of ranolazine and be force titrated to 1gm po BID after 2 weeks. Down-titration would only be allowed for side effects. This would be on top of all standard medical therapy.
16211522|NCT01304082|Drug|Lidocaine|1 ml subcutaneous injection of 0.9% lidocaine, given once
16211523|NCT01304082|Drug|normal saline|1 ml subcutaneous injection 0.9% sodium chloride, given once
16211524|NCT01304082|Drug|alkalinized lidocaine|1 ml subcutaneous injection of 0.9% lidocaine and 0.84% sodium bicarbonate
16211525|NCT01304069|Drug|Placebo|The subjects will be given orally placebo twice a day for 7 days prior to the study.
16211526|NCT01304069|Drug|Selecoxib|The subjects will be given orally selecoxib 200mg twice a day for 7 days prior to the study.
16211527|NCT01304069|Drug|Etoricoxib|The subjects will be given orally etoricoxib 120mg once a day for 7 days prior to the study.
16211528|NCT01304056|Device|Ventilatory therapy|
16211529|NCT01304043|Drug|chemotherapies protocols|Cisplatine 20 mg/m² IV Etoposide 100 mg/m² IV Bléomycine 30 mg IV
16211530|NCT01304030|Behavioral|Empathy Training Modules|The Empathy Training Modules utilize translational research in emotion expression basic science, physiology of emotions, decoding facial expressions and self-regulation skills as pertaining to management of medical and surgical patients.
16211531|NCT01304030|Behavioral|Residency Training as usual|Residents will receive their typical didactic and clinical education
16211532|NCT01304017|Other|Virtual Reality|The VR-therapy will include the playing of various virtual reality or video-games which encourages the use of the extremities while sitting and standing
16211533|NCT01304017|Other|Traditional Therapy|The traditional therapy will include exercise for balance and walking and for the upper extremity using traditional therapeutic tools such as balls, weights, chairs, bands, steps, etc.
16211534|NCT01304004|Other|Satiety|"Intervention Description: Consumption of the 2 drinkable yogurts separated by 4 weeks:
~Experimental drinkable yogurt enriched in proteins and fibres
~Placebo drinkable yogurt (isocaloric and isovolumetric)"
16211535|NCT01303991|Other|Hexvix PDT with Karl Storz T-Light|
16211536|NCT01303978|Drug|APD421|Single dose
16211537|NCT01303965|Drug|Sirolimus|Start on Day -3 and continue for 1 year
16211538|NCT01303965|Drug|Tacrolimus|Start on Day -3 and begin tapering on Day +100 until Day +180.
16211539|NCT01303965|Drug|Lenalidomide|Start between Day +30 and +120 and continue for 1 year.
16211540|NCT01303952|Drug|Eculizumab|Weekly treatment with eculizumab (600 mg) via IV infusion for 4 doses followed the next week by eculizumab (900 mg) IV infusion and maintenance treatment with Eculizumab (900 mg) via IV infusion every other week for 21 weeks
16211541|NCT01303939|Diagnostic Test|magnetic resonance imaging (MRI) of the brain|High resolution three-dimensional T1-weighted magnetic resonance imaging (MRI) was obtained from each participant at one visit.
16211542|NCT01303926|Drug|cisplatin pemetrexed|Cisplatin 75 mg / m2 d1 with Pemetrexed 500 mg / m2 d1 every 3 weeks for 6 cycles followed (in responding or stable patients) by Pemetrexed 500 mg / m2 every 3 weeks, until progression or unacceptable toxicity
16211543|NCT01303926|Drug|carboplatin paclitaxel bevacizumab|Carboplatin AUC 6 d1 plus Paclitaxel 200 mg/m2 d1 and Bevacizumab 15 mg/kg every 3 weeks for 6 cycles followed in stable or responding patients by Bevacizumab 15 mg/kg every 3 weeks, until progression or unacceptable toxicity
16211544|NCT01303887|Drug|Rituximab|Rituximab 375mg/m2 IV day 1,repeated every 21 days for 8 cycles. All patients who have achieved a CR or PR to induction therapy will receive rituximab maintenance (375mg/m2 every 2 months for 2 years).
16211545|NCT01303887|Drug|Cyclophosphamide|Cyclophosphamide 250mg/m2 PO day 1-3, repeated every 21 days for 4 (R-FC) or 8 cycles (R-CVP)
16211546|NCT01303887|Drug|Vincristine|Vincristine 1.4mg/m2 IV day 1,repeated every 21 days for 8 cycles.
16211547|NCT01303887|Drug|Prednisolone|Prednisolone 40mg/m2 PO day 1-5, repeated every 21 days for 8 cycles.
16211548|NCT01303887|Drug|Fludarabine|Fludarabine 40mg/m2 PO day 1-3,repeated every 21 days for 4 cycles
16211549|NCT01303874|Drug|Etanercept (ETN)|ETN 50 mg subcutaneous (SC) injections once weekly and MTX orally once weekly.
16211550|NCT01303874|Drug|Placebo|ETN-matching placebo SC injections once weekly and MTX orally once weekly.
16211551|NCT01303861|Drug|Varenicline|For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive varenicline at a dose of 0.5 mg once per day followed by 0.5 mg twice a day for the remaining 4 days of that week. Subsequently, the dose will be 1 mg twice per day, and will remain at that dose for the remainder of the 12 weeks.
16211552|NCT01303861|Drug|Bupropion|For the first 3 days after being switched from nicotine patches (occurring at one week before the target quit date), smokers in this group will receive bupropion at a dose of 150mg once per day. Subsequently, the dose will be 150mg twice per day, and will remain at that dose for the remainder of the 12 weeks.
16211553|NCT01303861|Drug|Nicotine patches|"Nicotine Replacement Therapy Groups:
~For smokers with high baseline carbon monoxide (CO): 42 mg/24 h for 2 weeks before the quit date and 3 weeks after the quit date, 21 mg/24 h for 4 weeks, 14 mg/24 h for 2 weeks, and 7 mg/24 h for 2 weeks; or
~For smokers with low baseline CO: 21 mg/24 h for 2 weeks before the quit date and 7 weeks after the quit date, 14 mg/24 h for 2 weeks, and 7 mg/ 24 h for 2 weeks.
~Varenicline and varenicline in combination with bupropion groups:
~For smokers with high baseline CO: 42 mg/24 h for 1 week
~For smokers with low baseline CO: 21 mg/24 h for 1 week"
16211554|NCT01303861|Drug|Nicotine Inhaler|Nicotine inhaler to use as needed after quit date
16211555|NCT01303848|Other|Blood Sampling|Blood Sampling over 24 hours
16211556|NCT01303835|Drug|LDN|Randomized patients received 4.5 mg low dose naltrexone (LDN) to be taken every night before bed.
16211557|NCT01303835|Drug|Placebo|Randomized patients received placebo to be taken every night before bed.
16211558|NCT01303822|Behavioral|Mindfulness-based day-care clinic group program|11 weeks of mindfulness-based day-care clinic group program. 6 hours per week.
16211559|NCT01303809|Other|Enhanced Recovery After Surgey for Sleeve Gastrectomy|"Intraoperative:
~Pre-op carbohydrate loading
~No pre-op GIK while NBM
~Pre-medication
~Dexamethasone 4mg as antiemetic, IV Paracetamol (first dose) Parecoxib 40mg
~Ondansetron regularly for first 48 hours and Cyclizine, Droperidol or Scopaderm as rescue antiemetics
~Fluid restriction
~Standardised method of anaesthesia
~Give 40ml 0.5% bupivacaine with adrenaline administered prior to placement of laparoscopic port sites
~10ml 0.75% ropivacaine diluted to 50ml with 0.9% normal saline solution administered to surgical site prior to procedure
~Postoperative:
~Rescue PCA for up to 12 hours. Oxynorm 5mg for rescue pain. Oxycontin 20mg bd/prn postoperatively
~Maintenance IV fluids (60ml/hr plasmalyte to be stopped 0800 day 1 post op). Clear oral fluids 2 hours post op. Bariatric free oral fluids morning of day 1
~Post operative oxygenation
~Incentive spirometry
~Drains (e.g. IDC) removed in recovery
~Full mobilisation 4-8 hours post op)
~Early Follow up"
16211560|NCT01303796|Drug|Sapacitabine|oral sapacitabine capsules
16211561|NCT01303796|Drug|Decitabine|decitabine intravenous
16211562|NCT01303783|Drug|Candesartan cilexetil (Atacand), 4 mg|4 mg of candesartan as capsule
16211563|NCT01303783|Drug|Candesartan cilexetil (Atacand), 8 mg|8 mg candesartan as capsule
16211564|NCT01303783|Drug|Nifedipine GITS (Adalat, BAYA1040), 20 mg|20 mg nifedipine as tablet
16211565|NCT01303783|Drug|Nifedipine GITS (Adalat, BAYA1040), 30 mg|30 mg nifedipine as tablet
16211566|NCT01303783|Drug|Nifedipine GITS (Adalat, BAYA1040), 60 mg|60 mg nifedipine as tablet
16211567|NCT01303783|Drug|Placebo|3 different placebo tablets corresponding nifedipine doses and 1 placebo capsule corresponding to candesartan doses
16211568|NCT01303783|Drug|Candesartan cilexetil (Atacand), 16 mg|16 mg of candesartan as capsule
16211569|NCT01303783|Drug|Candesartan cilexetil (Atacand), 32 mg|32 mg of candesartan as capsule
16211570|NCT01303770|Behavioral|Self-management cognitive rehabilitation group intervention|8-week cognitive rehabilitation program facilitated by an occupational therapist. Program goals include increased knowledge of cognitive impairments in multiple sclerosis, increased self-efficacy to manage cognitive changes and increased use of cognitive compensatory strategies.
16211571|NCT01303770|Behavioral|Control intervention|8-week group program that is not specifically directed to management of cognitive impairments.
16211572|NCT01303757|Behavioral|Dietary counselling|
16211573|NCT01303744|Drug|CHF 5074 1x|oral tablet, 1x, once a day in the morning for 12 weeks
16211574|NCT01303744|Drug|CHF 5074 2x|oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 8 weeks
16211575|NCT01303744|Drug|CHF 5074 3x|oral tablet, 1x, once a day in the morning for 4 weeks, followed by oral tablet, 2x, once a day in the morning for 4 weeks, followed by oral tablet, 3x, once a day in the morning for 4 weeks
16211576|NCT01303744|Drug|Placebo|oral tablet, once a day in the morning for 12 weeks
16211577|NCT01303731|Drug|Bupivacaine and Fentanyl|Spinal anesthesia with Marcaine Spinal 0.5% Heavy 7.5 mg (1.5 ml) diluted in 0.75ml of patient's CSF (0.25 ml)with addition of Fentanyl 12.5 mcg (total 2.5 ml)
16211578|NCT01303731|Drug|Bupivacaine|Spinal anesthesia with Marcaine Spinal 0.5% Heavy 12.5 mg (2.5 ml)
16211579|NCT01303718|Device|CardioFit® System|Vagal nerve stimulation with the CardioFit® system
16211580|NCT01303718|Other|Standard of Care|Usual care for LV dysfunction and heart failure (no CardioFit System implant)
16211581|NCT01303705|Drug|Anti-OX40|Anti-OX40 will be administered intravenously at 0.4 mg/kg on days 4, 6 and 8 of the study. The total anti-OX40 dose will be reconstituted in 100 ml 0.9% saline and infused over no more than 60 minutes intravenously. A single-use non-pyrogenic durapore membrane low protein binding filter (e.g.: Braun 1.2 micron air eliminating filter or equivalent) shall be used to filter the study product in the line between infusion bag and patient.
16211582|NCT01303705|Radiation|Radiation|8.0 Gy in 1 fraction to a maximum of three bone metastatic deposits will be administered on Day 4 of treatment. Imaging such as bone scan, MRI, CT scan, or radiograph must identify the target lesion as consistent with metastatic disease. Any bone lesion that is inducing pain or where there may be a clinical concern for potential pathological fracture will be selected over asymptomatic lesions.
16211583|NCT01303705|Drug|Cyclophosphamide|CTX will be administered on day 1 (Friday only) at a dose determined by cohort assignment. The drug should be diluted per institutional standards. An added dose of IV fluids may help prevent bladder toxicity. In this protocol, CTX will be administered intravenously over 30 - 60 minutes.
16211584|NCT01303679|Drug|Paclitaxel|IV, 80mg/m² at d1, d8, d15
16211585|NCT01303679|Drug|Bevacizumab|IV, 10 mg/kg at d1, d15 or IV, 15 mg/kg every 3 weeks
16211586|NCT01303679|Drug|Exemestane|daily 25 mg (1 pill) oral intake
16211587|NCT01303666|Procedure|Intra-articular CSI|After full aseptic preparation, 40 mg triamcinolone acetonide and 2 ml 1% lignocaine were injected into the joint cavity using the medial patello-femoral approach via a 21-gauge needle.
16211588|NCT01303666|Procedure|TI of the knee|"This was done as a day case procedure under local anaesthetic. The medial patello-femoral approach was used. After full aseptic preparation, the skin and soft tissues were infiltrated with 5e10 ml of 1% lignocaine. The joint was then instilled with a further 10 ml of 1% lignocaine.
~After an initial puncture using a scalpel, a 3.2 mm diameter wrist arthroscope was advanced into the joint cavity. Up to 1 l of 0.9% normal saline was then irrigated through the joint: saline was run into the joint until fully distended and then allowed to flow out of the joint in a cyclical method until the aspirated fluid runs clear for at least three successive cycles."
16211589|NCT01303653|Procedure|endoscopic closure of gastrointestinal fistulas and perforations|novel endoscopic tissue closure devices will be used for endoscopic closure of gastrointestinal fistulas or perforations
16211590|NCT01303640|Device|Biolimus-eluting stent|Biolimus-eluting stent
16211591|NCT01303640|Device|Everolimus-eluting stent|Everolimus-eluting stent
16211592|NCT01303627|Drug|remifentanil|1-4 ng/mL i.v. infusion during the surgery, maintenance dosage till LMA removal is 1.5 ng/mL.
16211593|NCT01303614|Drug|Lidocaine-Prilocaine cream|Implementation of 3 cm of lidocaine-prilocaine in the endocervical canal, 10 minutes before the intervention with a syringe without needle 5ml. Application, with a swab of the anesthetic cream ectocervix level.
16211594|NCT01303614|Drug|placebo|3 cm of gel application for the transmission of ultrasound into the endocervical canal 10 minutes before surgery, with a 5 ml syringe without needle. Application, with a swab in gel ectocervix.
16211595|NCT01303601|Drug|olanzapine|"Tablet The initial dose of olanzapine was 5mg daily and raised to 10 mg/day. After week 1, flexible dosing was allowed based on symptom response, up to 20 mg daily, as tolerated.
~daily 6 weeks"
16211596|NCT01303601|Drug|Starch|
16211597|NCT01303588|Behavioral|Yoga|24 group training sessions Yoga, 2 training sessions per week, 45 min duration , over 3 months
16211598|NCT01303588|Behavioral|Qigong|12 group training sessions Qigong, 1 training per week, 90 min duration , over 3 months
16211599|NCT01303575|Behavioral|HIV, STI and Pregnancy Prevention Curriculum|"A complete internet-based, It's Your Game...Keep It Real Intervention Program"
16211600|NCT01303575|Behavioral|Control Curricula|A computer-based, science education program that does not contain elements of sexual health education
16211601|NCT01303562|Other|Whole grain oats and barley|One time dose of 48 g whole grain flour in 2 small muffins (24 g flour per muffin) per intervention
16211602|NCT01303549|Drug|Anidulafungin|Anidulafungin once a day for 14 days: initial dose 200 mg/day IV administered in 180 minutes. Following doses 100 mg/day IV administered in 90 minutes.
16211603|NCT01303549|Drug|Liposomal amphotericin B|Liposomal amphotericin B once a day for 14 days: 3 mg/kg/day. IV administration during 60 minutes.
16211604|NCT01303536|Drug|Ondansetron|obsessive compulsive patients resistant to selective serotonin reuptake inhibitor therapy, in addition to their continued stable dose of FDA approved selective serotonin reuptake inhibitors, received oral ondansetron 0.25 mg in two daily administrations (0.5 mg daily) for 2 weeks. Subsequently, the dose was titrated to 0.5 mg in two daily administrations (1 mg/day total) for another 10 weeks. ondansetron was discontinued and the patients were followed for an additional 4 week with biweekly
16211605|NCT01303510|Biological|Inflexal V|"Inflexal V influenza vaccine, formulated for the WHO requirements ofr the 2008-2009 season, containing per 0.5 mL dose:
~15 µg hemagglutinin (HA) antigen of A/Brisbane/59/2007 (H1N1)-like virus
~15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus
~15 µg HA antigen of B/Florida/4/2006-like virus
~Dose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Day 1"
16211606|NCT01303497|Drug|Paclitaxel|Day 1, 8 and 15 : Paclitaxel 90 mg/m², IV over 1h, during 6 cycles (1 cycle = 28 days)
16211607|NCT01303497|Drug|Bevacizumab|"Bevacizumab until progression or inacceptable toxicity :
~During the cycles of chemotherapy : Day 1 and D15 : 10 mg/kg,IV
~After 6 cycles of chemotherapy : 15 mg/kg, IV"
16211608|NCT01303484|Dietary Supplement|Bi2muno® GOS|5.5g/day for 10 weeks
16211609|NCT01303484|Dietary Supplement|Maltodextrin|5.5g daily for 10 weeks
16211610|NCT01303471|Drug|opioid (remifentanyl)|Infusion of remifentanyl (opioid) will be started at different levels for each group of the randomized study : 0 ng/ml (group 0), 1 ng/ml (group 1), 3 ng/ml (group 3) or 4 ng/ml (group 4)
16211611|NCT01303458|Behavioral|Basic Needs Surveillance (BNS) protocol|The BNS intervention will consist of 4 components: 1) WE CARE survey which mothers will fill out in the waiting room prior to their child's WCC visits; 2) Family Resource book containing 1-page information sheets on resources, that providers will have access to in exam rooms; 3) a Community Resource Coordinator who will assist families link to available resources, and update providers; 4) Training Session which will provide a 1 hr overview of the intervention to providers
16211612|NCT01303445|Drug|Aggrenox alone|Aggrenox 1 capsule twice daily for 7 days
16211613|NCT01303445|Drug|Aggrenox and omeprazole|Aggrenox 1 capsule twice daily and omeprazole 80mg once daily for 7 days
16211614|NCT01303445|Drug|Aggrenox and omeprazole|Aggrenox 1 capsule twice daily and omeprazole 80mg once daily for 7 days
16211615|NCT01303445|Drug|Omeprazole alone|omeprazole 80 once daily for 7 days
16211616|NCT01303432|Dietary Supplement|Yogurt supplemented with Mobilee|One yogurt (125mL) per day including 80mg of Mobilee
16211617|NCT01303432|Dietary Supplement|Yogurt|One yogurt (125mL) per day
16211618|NCT01303419|Device|CE-BMRI|Contrast-enhanced breast imaging using Magnetic Resonance
16211619|NCT01303419|Device|DE-CEDM|Breast imaging using Dual-energy, contrast-enhanced digital mammography
16211620|NCT01303406|Drug|Idebenone|All PROTI patients randomised to idebenone treatment will receive high dose idebenone. This is defined according to body weight. In patients weighing 45 kg or less, it is 1350 mg/day (3 x 150 mg tablets three times per day with meals). In patients weighing more than 45 kg, it is 2250 mg/day (5 x 150 mg tablets three times per day with meals).
16211621|NCT01303406|Drug|Placebo|
16211622|NCT01303380|Drug|Canakinumab|
16211623|NCT01303354|Procedure|Lumbar Transforaminal Epidural Steroid Injection|
16211624|NCT01303341|Other|Laboratory Biomarker Analysis|Correlative studies
16211625|NCT01303341|Other|Pharmacological Study|Correlative studies
16211626|NCT01303341|Drug|Riluzole|Given PO
16211627|NCT01303341|Drug|Sorafenib Tosylate|Given PO
16211628|NCT01303328|Drug|C1|Local application of the experimental gel or placebo gel.
16211629|NCT01303315|Device|TANTALUS System|An Active Implantable Pulse Generator Medical Device for the treatment of Obesity and Diabetes Type 2 and Obesity
16211630|NCT01303302|Device|Tantalus System|The TANTALUS System is an active implantable device, generating Gastric contractility modulation (GCM) stimulation for the treatmnet of type 2 diabetes
16211631|NCT01303302|Device|TANTALUS system|The TANTALUS System is an active implantable device, generating Gastric contractility modulation (GCM) stimulation for the treatmnet of type 2 diabetes. In the sham comparator the device is off.
16211632|NCT01303289|Dietary Supplement|T-Diet plus Standard|T-Diet plus Standard is a complete balanced protein and energy oral nutrition supplement, indicated for the dietary management of patients with related malnutrition.
16211633|NCT01303289|Dietary Supplement|Jevity|JEVITY is a diet for tube-fed patients in the medium to long term, to varying degrees of malnutrition with gastrointestinal disorders.
16211634|NCT01303263|Behavioral|Educational Intervention|45-minute teaching session on healthcare costs, in which each resident reviewed an itemized hospital bill for a patient he/she had cared for, followed by an open-ended discussion about reducing unnecessary costs.
16211635|NCT01303250|Drug|balanced 6% hydroxyethylstarch 130/0.4|Fluid administration and optimization based on cardiac output findings during surgery.
16211636|NCT01303250|Drug|balanced crystalloid|Fluid administration and optimization based on cardiac output findings during surgery.
16211637|NCT01303237|Drug|Cetuximab + RT|Cetuximab initial dose 400 mg/m² on week 1; Cetuximab maintenance dose 250 mg/m² continued for 7 weeks plus concomitant RT
16211638|NCT01303224|Drug|Ibodutant|Oral tablet, low dose, once daily, for 8 weeks
16211639|NCT01303224|Drug|Ibodutant|Oral tablet, intermediate dose, once daily, for 8 weeks
16211640|NCT01303224|Drug|Ibodutant|Oral tablet, high dose, once daily, for 8 weeks
16211641|NCT01303224|Drug|Placebo|Oral tablet, (identical in appearance and weight to Ibodutant tablets), once daily, for 8 weeks
16211642|NCT01303198|Device|APAP - Therapy|automatic positive pressure therapy
16211643|NCT01303172|Biological|IMM-101|"IMM-101 is a suspension of heat-killed whole cell M. obuense in borate-buffered saline.
~A single 0.1 mL intradermal injection of IMM-101 (10 mg/mL) will be administered every 2 weeks for the first 3 doses followed by a rest of 4 weeks then every 2 weeks for the next 3 doses followed by every 4 weeks thereafter.
~Chemotherapy plus IMM-101 will be offered until intolerable toxicity or withdrawal from the study up to a maximum of 12 cycles of gemcitabine."
16211644|NCT01303172|Drug|Gemcitabine|"Gemcitabine will be administered intravenously at 1000 mg/m2 over 30 minutes once weekly for 3 consecutive weeks out of every 4 weeks.
~Chemotherapy will be offered until intolerable toxicity or withdrawal from the study up to a maximum of 12 cycles (i.e. approximately 48 weeks).
~Dosage reduction with each cycle or within each cycle may be applied based upon the grade of Gemcitabine-related toxicity experienced by the patient using centre's standard protocol."
16211645|NCT01303159|Device|Endoscopic bipolar radiofrequency probe (ENDOHPB)|EndoHPB (EMcision Ltd, UK) is a single use sterile device for use at ERCP or PTC. It is a 8F (2.6mm) catheter with a 1.8m working length, that is designed to be inserted into the target duct of the hepatic, biliary or pancreatic system over a guide wire. The device is compatible with endoscopes that have a working channel of 3.2mm or greater. It comprises of a coaxial over the wire (OTW) catheter with 2 ring electrodes spaced 8mm apart at its distal end. The distal electrode is 5mm from the leading edge of the catheter. The two electrodes at the distal end of EndoHPB are designed to produce a heating zone length of approximately 25 mm.
16211646|NCT01303146|Drug|rhARSA|intravenous infusion 100U/kg every other week for 18 months
16211647|NCT01303120|Drug|Femoral Nerve Block|Preoperative Bupivacaine 0.5%, perineurally as single shot
16211648|NCT01303120|Drug|Combined nerve blocks|Preoperative Bupivacaine 0.5%, perineurally as single shot
16211649|NCT01303120|Drug|Patient-controlled analgesia|Patient controlled analgesia with morphine
16211650|NCT01303107|Drug|Bupivacaine|single dose of 15 mg by a slow injection rate of 1 mL/s
16211651|NCT01303094|Drug|Trabectedin|Trabectedin will be administered without drug holiday in Arm A until unacceptable toxicity, progressive disease or patient decision. The treatment beyond disease progression and in case of intolerance will be decided according to investigator discretion. In case of progression after drug discontinuation by patient decision, a re-challenge of Trabectedin is possible.
16211652|NCT01303094|Other|Drug: holiday|A drug-holiday will start after the 6th cycle until disease progression, and then Trabectedin will be re-challenged. Trabectedin will be administered until unacceptable toxicity, second evidence of progressive disease or patient decision.
16211653|NCT01303081|Behavioral|Individual Rewards|If participants quit smoking by their target quit date, and that is confirmed by cotinine/anabasine tests, they will receive a monetary award from the study investigators.
16211654|NCT01303081|Behavioral|Fixed Deposits|Participants will have to deposit a certain monetary amount of their own money as an incentive to quit smoking. If they quit smoking by their target quit date, and that is confirmed by cotinine/anabasine tests, participants will receive their deposit back. If participants do not quit, their money will be used to support future research studies designed to help people stop smoking.
16211655|NCT01303081|Behavioral|Chosen Deposits|Participants will choose their deposit amount (XX = chosen deposit); this same amount will be returned upon success (that is, quit smoking by the target quit date, and having this confirmed by cotinine/anabasine tests). If participants do not quit, their money will be used to support future research studies designed to help people stop smoking. The default deposit will be set to a certain monetary amount for consistency with other arms, and participants can increase or decrease this amount until they reach the amount they want to deposit.
16211656|NCT01303081|Behavioral|Competitive Deposits (Pari-Mutuel)|"Groups (or cohorts) of 6 smokers each will be formed on a rolling basis, linking individuals with target quit dates (day 0's) near each other. Participants will deposit a certain monetary amount (Y) in an account, and the payout for quitting on this arm will be Y x 6/Q , where Q is the number of quits in the cohort. Again, success will be confirmed by cotinine or anabasine tests, and if participants do not quit, their money will be used to support future research studies designed to help people stop smoking."
16211657|NCT01303081|Behavioral|Usual Care|Participants will receive reimbursements for completing the surveys that are part of the Way To Quit program and for submitting saliva or urine samples at 14 days and 3 months (among those eligible).
16211658|NCT01303068|Device|13C urea breath test Kit|20 and 50 mg, 13C urea breath test: urea nebulizer solution to detect Pseudomonas
16211659|NCT01303055|Drug|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily : two years
16211660|NCT01303055|Drug|Metformin 750 mg|"Metformin 750 mg, tablets, orally, thrice daily: two years
~The dose increase is possible up to its maximum, 2250 mg, so that HbA1c is maintained below 6.9 %."
16211661|NCT01303042|Drug|Insulin lispro mix 50/50|Insulin lispro mix 50/50 t.i.d : six months
16211662|NCT01303029|Drug|Gemcitabine+erlotinib|Gemcitabine 1000mg/m2 over 30 minutes on days 1, 8, 15. Erlotinib will be administered orally at a dose of 100 mg daily from day 1 to day 28, repeated every 4 weeks .
16211663|NCT01303029|Drug|Gemcitabine+erlotinib+capecitabine|Gemcitabine 1000mg/m2 over 30 minutes on days 1, 8, 15. Capecitabine will be administered orally 1.660 mg/m2 day from day 1 to day 21. Erlotinib will be administered orally at a dose of 100 mg daily from day 1 to day 28, repeated every 4 weeks .
16211664|NCT01303016|Dietary Supplement|Chispuditos|Daily dose per child is 1 heaping Tablespoon of Chispuditos (using the appropriate measuring spoon provided to each participant), 1 teaspoon of sugar if desired (using appropriate measuring spoon provided to each participant), mixed with 8 ounces of water or milk. The mixture is stirred over a heat source (fire or stove) until the mixture boils for 8 minutes.
16211665|NCT01303003|Drug|Dexamethasone|40 cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side.
16211666|NCT01303003|Procedure|TAP block|Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side
16211667|NCT01302990|Biological|Dose given at Day 0|Dose given by intramuscular administration (0.5 mL)
16211668|NCT01302977|Procedure|Fetal tracheal occlusion|Insertion of a detachable balloon inside fetal trachea by percutaneous fetoscopy
16211669|NCT01302964|Drug|Placebo|Subjects randomized to placebo will receive placebo for duration of the study
16211670|NCT01302964|Drug|Mirtazapine|Subjects will receive 7.5 mg daily at the start of the trial. The dose will be increased by 7.5 mg per week for subjects weighing less than 50 kg and up to 15 mg per week for subjects weighing more than 50 kg depending on efficacy and tolerability.
16211671|NCT01302951|Drug|Moxifloxacin 400 mg|The patients receive MXF 400 mg as one hour intravenous infusion at randomized timed intervals prior to liver resection.
16211672|NCT01302938|Drug|Tolterodine ER|One 4 mg capsule will be taken with water every day with or without food. It should be swallowed whole without chewing.
16211673|NCT01302938|Drug|Placebo|A placebo of Tolterodine ER 4 mg will be taken with water every day with or without food. It should be swallowed whole without chewing.
16211674|NCT01302925|Drug|PEP005 Gel|PEP005 Gel 0.05% for 2 consecutive days
16211675|NCT01302925|Drug|PEP005 Gel|PEP005 Gel 0.015% for 3 consecutive days
16211676|NCT01302912|Procedure|Lymphoma-Biopsy|Patients after biopsy of orbital lymphoma
16211677|NCT01302899|Drug|Aliskiren|Aliskiren 150 mg (Tablet)
16211678|NCT01302899|Drug|Placebo to Aliskiren|Aliskiren 150 mg Matching Placebo (Tablet)
16211679|NCT01302899|Drug|Hydrochlorothiazide (HCTZ)|HCTZ 25mg (Capsule)
16211680|NCT01302899|Drug|Placebo to Hydrochlorothiazide (HCTZ)|HCTZ 25mg (Capsule) Matching Placebo
16211681|NCT01302899|Drug|Ramipril|Ramipril 10mg (Tablet)
16211682|NCT01302886|Drug|BHQ880|
16211683|NCT01302873|Drug|BGG492A|
16211684|NCT01302873|Drug|BGG492A|
16211685|NCT01302860|Drug|ACZ885|
16211686|NCT01302847|Drug|Dolutegravir (DTG) film-coated tablets|"Stage I: Initial starting dose of DTG tablet(s) at approximately 1 mg/kg, to be taken orally once or twice daily.
~Stage II: Stage I-approved dose of DTG to be taken orally once or twice daily."
16211687|NCT01302847|Drug|DTG granules for suspension|"Stage I: DTG granules for suspension, to be taken orally once or twice daily. Dose will vary for each participant.
~Stage II: Stage I-approved dose of DTG to be taken orally once or twice daily. (Note: Cohort IIB will not be included in Stage II of the study)."
16211688|NCT01302847|Drug|DTG dispersible tablets|"Stage I: DTG dispersible tablets, to be taken orally once or twice daily. Dose will vary for each participant.
~Stage II: Stage I-approved dose of DTG to be taken orally once or twice daily."
16211689|NCT01302834|Biological|cetuximab|400 mg/m2 IV 5-7 days before IMRT then 250 mg/m2 IV weekly for 7 weeks
16211690|NCT01302834|Drug|cisplatin|100 mg/m2 IV on days 1 and 22 of IMRT
16211691|NCT01302834|Radiation|IMRT|35 fractions over 6 weeks, 6 fractions per week, 2 Gray per fraction to total dose of 70 Gy.
16211692|NCT01302821|Biological|Adenovirus-p53 transduced dendritic cell vaccine|The Ad.p53 DC vaccine will be injected intradermally (through the skin) into four separate sites. The patient's vaccine will be the same dose throughout the study.
16211693|NCT01302821|Drug|1-methyl-D-tryptophan|Each treatment cycle is comprised of 21 days. The treatment is continuous with no breaks in between cycles. Patients would not be allowed to take any tryptophan containing supplements while participating on this study.
16211694|NCT01302821|Radiation|Carbon C 11 alpha-methyltryptophan|The experimental examination for this research is the administration by a needle in a vein of Tryptophan labeled with a radioactive tracer (a substance is believed to enhance imaging for easier detection and measurement), Carbon 11, when when the patient has not eaten for five hours. A standard PET/CT scanner is then used to create images of the tracer a few minutes later.
16211695|NCT01302808|Combination Product|Erlotinib plus Romidepsin (8 mg/m^2)|
16211696|NCT01302808|Combination Product|Erlotinib plus Romidepsin (10 mg/m^2)|
16211697|NCT01302808|Combination Product|Erlotinib plus Romidepsin (10 mg/m^2) + Antiemetic prophylaxis|
16211698|NCT01302808|Combination Product|(Erlotinib plus Romidepsin (8mg/m^2)) + Antiemetic prophylaxis|
16211699|NCT01302795|Drug|Canakinumab|Monoclonal antibody inhibiting interleukin 1 beta
16211700|NCT01302769|Device|Standard treatment plus ear acupuncture|Standard treatment plus ear acupuncture
16211701|NCT01302756|Other|Placebo|Group 1: Placebo plus standard of care pre-natal vitamins (which include 1 milligram of folic acid) a day for the duration of pregnancy
16211702|NCT01302756|Dietary Supplement|Folic Acid|Group 2: 4-milligrams of folic acid a day for the duration of pregnancy plus standard of care pre-natal vitamins (which include 1 milligram of folic acid)
16211703|NCT01302743|Drug|Group 1: Metformin|Group 1: Will receive oral extended-release Metformin 1000 mg once a day for 90 days
16211704|NCT01302743|Dietary Supplement|Group 2: Cinnamon Bark|Group 2: Will receive Cinnamon Bark 1000 mg once a day for 90 days
16211705|NCT01302743|Dietary Supplement|Group 3: Cinnulin PF|Group 3: Will receive Cinnulin PF 500 mg once a day for 90 days.
16211706|NCT01302717|Device|LV pacing|The left ventricular lead are positioned preferentially at the posterolateral or lateral venous branches of the coronary sinus.
16211707|NCT01302717|Device|RV pacing|The right ventricular lead are positioned at the right ventricular apex.
16211708|NCT01302691|Drug|losartan potassium + hydrochlorothiazide + amlodipine besylate (MK-0954E)|One tablet, containing 50 mg losartan potassium, 12.5 mg hydrochlorothiazide, and 5 mg amlodipine besylate, orally, once daily, for 8 weeks.
16211709|NCT01302691|Drug|Losartan potassium|One tablet, containing 50 mg losartan potassium, orally, once daily, for 8 weeks.
16211710|NCT01302691|Drug|Amlodipine besylate|One capsule, containing 5 mg amlodipine besylate, orally, once daily, for 8 weeks.
16211711|NCT01302691|Drug|Placebo to MK-0954E|One tablet, containing placebo, orally, once daily, for 8 weeks.
16211712|NCT01302691|Drug|Placebo to losartan potassium|One tablet, containing placebo, orally, once daily, for 8 weeks.
16211713|NCT01302691|Drug|Placebo to amlodipine besylate|One capsule, containing placebo, orally, once daily, for 8 weeks.
16211714|NCT01302639|Dietary Supplement|Comparison of different combinations of polyphenols with respect to effects on fat oxidation|EGCG, resveratol and genistein
16211745|NCT01302379|Drug|Metformin|Week 1: 500 mg at dinner time Weeks 2-4: 1000 mg at dinner time Weeks 5+: 500 mg in morning; 1000 mg at dinner time
16212856|NCT01293149|Drug|Clonidine|clonidine 1 mcg/kg AND ropivacaine 0.2% 0.5 ml/kg (max 20 ml)
16211715|NCT01302613|Drug|Capecitabine|Capecitabine will be delivered concurrently with the radiation therapy, at a dose of 1650 mg/m2 divided in even BID doses. It will only be taken on the days of radiation treatment (Monday-Friday, except for holidays). The A.M. dose of the capecitabine must be taken at least one hour prior to the radiation treatment.
16211716|NCT01302613|Drug|5-FU|5-FU 400 mg/m2, iv bolus on day 1 followed by 2400 mg/m2 iv over 46 hours of each cycle. A cycle is delivered every two weeks. Three cycles will be given prior to the surgery. Five additional cycles will be given after surgery.
16211717|NCT01302613|Drug|Leucovorin|Leucovorin 400 mg/m2, IV, over 2 hours before 5-FU on day 1 of each cycle. A cycle is delivered every two weeks. Three cycles will be given prior to the surgery. Five additional cycles will be given after surgery.
16211718|NCT01302613|Drug|Oxaliplatin|Oxaliplatin 85mg/m2 IV on day 1 of each cycle. A cycle is delivered every two weeks. Three cycles will be given prior to the surgery. Five additional cycles will be given after surgery.
16211719|NCT01302613|Radiation|radiation|"28-30 fractions of radiation, given once a day, five days per week (Monday-Friday, except for holidays). The prescribed fraction dose is 180 cGy; the total radiation dose is thus 5040-5400 cGy. The primary treatment fields will be treated with 25 fractions of 180 cGy/fraction with a boost of 3-5 fractions of 180 cGy subsequently delivered."
16211720|NCT01302613|Procedure|total mesorectal excision|Optimal surgical technique involving use of total mesorectal excision (TME) is mandated. The type of surgery, either low anterior resection with sparing of the sphincter mechanism or sphincter-eliminating abdominoperineal resection (APR), will be at the discretion of the attending surgeon.
16211721|NCT01302600|Drug|Olesoxime|Liquid suspension formulation, 100 mg/ml at a dose of 10 mg/kg will be administered once a day with food at dinner
16211722|NCT01302600|Drug|Placebo|0.1ml/kg once a day with food at dinner.
16211723|NCT01302587|Drug|Albuterol|Albuterol MDI with integrated dose counter. Each participant will use 2 oral inhalations of 90 micrograms each of albuterol twice a day for the length of the study.
16211724|NCT01302574|Dietary Supplement|lactisole|Lactisole-liquid meal: Lactisole (450 ppm) will be mixed with a liquid meal. Liquid meal only: The comparator will be the liquid meal alone.
16211725|NCT01302561|Dietary Supplement|Sucrose|5 g of sucrose twice daily for 24 weeks
16211726|NCT01302561|Dietary Supplement|Galactooligosaccharide|2.5 g galactooligosaccharide plus 2.5 g sucrose twice daily for 24 weeks
16211727|NCT01302548|Device|IRRISEPT|Device containing sterile water and chlorhexidine gluconate (CHG)
16211728|NCT01302548|Procedure|Usual Care|The usual care method will either be the saline irrigation or incision and drainage depending on the physicians discretion.
16211729|NCT01302535|Other|Yoga group with supervision (trainer)|The Yoga-with-trainer group will meet once a week (60 minutes) to practice yoga with a yoga instructor. The participants will be encouraged to practice yoga between the yoga classes at home for 30 minutes a day.
16211730|NCT01302535|Other|Yoga at home|The participants in the Yoga-at-home group will get a private doctor appointment (20 minutes) where they get instructions for two yoga exercises which they are encouraged to perform at home 15 minutes a day.
16211731|NCT01302522|Behavioral|Mental practice|All patients in the study will be administered a regimen of locomotor therapy (rehabilitative therapy working on walking). Half of the patients will also be administered a regimen in which they mentally rehearse the exercises that they have just physically performed.
16211732|NCT01302509|Dietary Supplement|industrialized oral supplementation (IOS) and tube feeding regimen (TFR) with Nutren|The oral and tube supplement offered was Nutren Jr® (for patients aged 1 - 9 years) or Nutren 1.0- Nestlé Clinical Nutrition-Brazil (for those aged 10 years or over). This supplement was a whole powder formulation that presented a macro composition of 52% carbohydrates, 12% proteins and 36% lipids. Its vitamins were A, D, E, K, B complex, biotin and choline; its trace elements were iron, copper, zinc, manganese, selenium, chromium and molybdenum; its macroelements were potassium, calcium, sodium, chlorine, iodine, magnesium and phosphorus; and it contained taurine and L-carnitine presenting 1.0 kcal/ml.
16211733|NCT01302496|Biological|TriMix-DC and ipilimumab|Patients will receive 5 administrations of autologous TriMix-DC, administrations 2, 3, 4 and 5 will be preceded by ipilimumab (a CTLA-4 blocking monoclonal antibody, at a dose of 10 mg/kg). Patients who are free from progression according to the irRC will be offered ipilimumab maintenance administrations of ipilimumab (10mg/kg q12wks).
16211734|NCT01302483|Drug|3% tetracaine HCL with 0.05% oxymetazoline HCL|1 sham injection along with 3 sprays of Kovacaine Nasal Spray in each nostril; a 4-minute interval between every set of sprays. The total dose of 3% tetracaine HCL with 0.05% oxymetazoline HCL was 18 mg/0.3 mg.
16211735|NCT01302483|Drug|Lidocaine Injection|Each subject received both an injection along with 3 sprays of isotonic saline sham in each nostril; a 4-minute interval between every set of sprays.
16211736|NCT01302470|Procedure|Primary epicardial placement of left ventricular lead|Epicardial leads will be placed on the left ventricle in the area of the most dyssynchrony . the leads will be attached to a Medtronic Cardiac resynchronization/ AICD/ device
16211737|NCT01302470|Procedure|Transvenous placement of left ventricular lead|Conventional placement of left ventricular leads performed in the electrophysiology department.
16211738|NCT01302444|Drug|Tadalafil|Tadalafil 40mg for 12 weeks
16211739|NCT01302444|Drug|Placebo|Placebo for 12 weeks
16211740|NCT01302431|Other|Manualised nurse-led telephone support|The manualised nurse-led telephone support intervention is designed to provide proactive support and enable caregivers of people with multiple sclerosis manage problems encountered with caregiving
16211741|NCT01302418|Device|artus Influenza A/B RT-PCR Test|The investigational assay, used for detecting the presence of Influenza A/B.
16211742|NCT01302405|Drug|PRI-724|Dose escalation
16211743|NCT01302392|Drug|Carfilzomib|20mg/m² IV on Days 1 and 2 of Cycle 1, escalating to 27 mg/m² IV on Days 8,9,15,and 16 of Cycle 1 and continuing on Days 1,2,8,9,15,and 16 of Cycles 2 through Cycle 9. Cycles 10 and beyond will receive 27 mg/m² IV on Days 1,2,15, and 16 (alternatively, the investigator could choose to continue the dosing frequency on the original dosing days [Days 1, 2, 8, 9, 15, 16] for individual subjects).
16211744|NCT01302392|Drug|Best Supportive Care|"Corticosteroid (either prednisolone 30 mg orally (PO) every other day, dexamethasone 6 mg PO every other day, or other equivalent corticosteroid).
~Optional cyclophosphamide 50 mg PO once daily may be given at the Investigator's discretion (maximum of 1400 mg per 28-day cycle)."
16212857|NCT01293136|Procedure|Femoral nerve block|Ropivacaine
16211746|NCT01302379|Drug|Placebo|Week 1: 1 pill at dinner time Weeks 2-4: 2 pills at dinner time Weeks 5+: 1 pill in morning; 2 pills at dinner time
16211747|NCT01302379|Behavioral|Lifestyle intervention|Telephone-based lifestyle intervention (dietary change and physical activity) for weight loss.
16211748|NCT01302379|Behavioral|Standard printed dietary guidelines|Set of standard health education materials provided to participants at single time point (immediately after randomization)
16211749|NCT01302366|Drug|TBL12|
16211750|NCT01302353|Drug|Emulsified Isoflurane|
16211751|NCT01302340|Drug|Delta-THC|Active treatment consists of THC in tablet form. Patients receive 0.75 mg THC twice daily during the first three treatment blocks (period A) and 1.5 mg THC twice daily during the latter three treatment blocks (period B). Placebo treatment consists of two tablets daily and is matched to the active treatment for taste, color and size. Study medication will be administered at 10 a.m. and 4 p.m., by the primary caregiver. These time points are chosen because NPS often occur later on the day, when fatigue and external signals build up to the stress and result in NPS. The order of administration of THC and placebo (1:1) will be determined by randomization per block: THC followed by placebo or placebo followed by THC.
16211752|NCT01302340|Drug|placebo|Active treatment consists of THC in tablet form. Patients receive 0.75 mg THC twice daily during the first three treatment blocks (period A) and 1.5 mg THC twice daily during the latter three treatment blocks (period B). Placebo treatment consists of two tablets daily and is matched to the active treatment for taste, color and size. Study medication will be administered at 10 a.m. and 4 p.m., by the primary caregiver. These time points are chosen because NPS often occur later on the day, when fatigue and external signals build up to the stress and result in NPS. The order of administration of THC and placebo (1:1) will be determined by randomization per block: THC followed by placebo or placebo followed by THC.
16211753|NCT01302340|Drug|Delta-THC|In case either 2 times daily 1 tablet 0,75mg or 2 times daily 1 tablet 1.5mg Delta-THC appeared to be efficacious for a particular patient, this patient can continue the effective dose of delta-THC in an open label extension phase during 6 months.
16211754|NCT01302327|Drug|Exenatide|Exenatide
16211755|NCT01302314|Behavioral|Goal management training (GMT)|Fourteen hours of GMT during a time period of three months.
16211756|NCT01302301|Procedure|Per oral endolumenal myotomy|flexible endoscopic submucosal esophageal partial myotomy
16211757|NCT01302288|Procedure|Per oral endolumenal myotomy|patient cohort having flexible endoscopic submucosal esophageal partial myotomy
16211758|NCT01302275|Drug|Oxcarbazepine|Oxcarbazepine capsules 300 mg is gradually increased from 300 mg/day to 2400 mg/day Placebo capsules increase from 1/day to 8/day
16211759|NCT01302249|Drug|Latanoprost 0.005%|q.d.
16211760|NCT01302249|Drug|AR-12286 Ophthalmic Solution 0.5%|
16211761|NCT01302249|Drug|Timolol maleate ophthalmic solution 0.5%|
16211762|NCT01302236|Drug|Eplerenone|50mg/day for all as initial dose, 100mg/day for the patients that still show hypertension(above 140/90mmHg)after one month 150mg treatment,oral,on 6 months
16211763|NCT01302210|Drug|Decolonization|5 day regimen of mupirocin calcium 2% twice daily to the nares and any open wound plus bath or shower with 4% chlorhexidine used as a liquid soap
16211764|NCT01302197|Other|No intervention|longitudinal follow-up after stroke
16211765|NCT01302184|Device|Lokomat®|"Patients of the experimental group were trained at 50% of BWS for 15 minutes and 30% of BWS for 15 minutes on the Lokomat®. Treadmill speed was initiated at 1.5km/h and increased to 3.0km/h by increments of 0.5km/h as tolerated.
~A physical therapist supervised the treatment, adjusting treadmill speed and BWS.
~Treatment was performed for 3 days/week, for 4 weeks"
16211766|NCT01302184|Device|Treadmill|"Patients of the control group had 30 minutes of treadmill gait training. After having calculated the speed during 6MWT, the patient was trained on a treadmill (RHC770CE - RAM Medical srl). They were trained using 80% of the maximum speed that the patient reached during the test for the first week, 90% for the second week, 100% for the third and fourth week.
~A Physical Therapist provided auditory cueing and direct, continuous feed-back to the patient.
~Treatment was performed for 3 days/week, for 4 weeks."
16211767|NCT01302171|Drug|granulocyte colony stimulating factor (GCSF)|10mcg/kg per day 5 days
16211768|NCT01302171|Procedure|bone marrow mononuclear cells|intra coronary injection of stem cells or placebo
16211769|NCT01302158|Drug|ASP1941|oral
16211770|NCT01302158|Drug|Glimepiride|oral
16211771|NCT01302145|Drug|ASP1941|Tablet
16211772|NCT01302145|Drug|Metformin|Tablet
16211773|NCT01302145|Drug|Placebo|Tablet
16211774|NCT01302132|Drug|ASP1941|Oral solution
16211775|NCT01302119|Drug|AN2690 Topical Solution, 5%|AN2690 Topical Solution, 5%, applied once daily for 48 weeks
16211776|NCT01302119|Drug|Solution Vehicle|AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks
16211777|NCT01302106|Drug|Clofarabine plus low dose Ara-C|Clofarabine 10 mg/m2 by a 1-hr i.v infusion, once daily, from day 1 to 5. Ara-C 10 mg/m2, subcutaneously, twice a day (q12 hrs), from day 1 to 15. Clofarabine will be given 4 hours before the 2nd dose of Ara-C.
16211778|NCT01302093|Drug|Racecadotril Film-Coated Tablet (FCT)|A single 100 mg dose of an experimental Racecadotril FCT administered orally with 240 ml of water, with a 7- day washout between visits
16211779|NCT01302093|Drug|Racecadotril Capsule|A single 100 mg dose of a marketed Racecadotril capsule administered orally with 240 ml of water, with a 7-day washout between visits
16211780|NCT01302080|Drug|sertraline|Non interventional study - drug, dose, duration etc as per USPI and clinician discretion
16211781|NCT01302080|Behavioral|psychotherapy|Non-interventional study- as above
16211782|NCT01302067|Drug|Fesoterodine 8mg|Oral, 1 tablet per day, 12 weeks duration, 8mg/day
16211783|NCT01302067|Drug|Fesoterodine 4mg|Oral, 1 tablet per day, 12 weeks duration, 4mg/day
16211784|NCT01302067|Drug|Placebo|Oral, 1 tablet per day, 12 weeks duration
16211785|NCT01302054|Drug|Fesoterodine 8 mg|Fesoterodine sustained release tablets once every morning at 4 mg dose for first week, followed by 11 weeks at 8 mg strength.
16211786|NCT01302054|Drug|Placebo|Matching placebo for fesoterodine 4 and 8 mg for a total of 12 weeks.
16211787|NCT01302041|Drug|Enzalutamide|Oral
16211788|NCT01302028|Drug|ASP1941|Oral
16211789|NCT01302015|Biological|RNL-Vascostem®|
16211790|NCT01302002|Drug|Metformin Pre-Surgery|500 mg tablet, taken twice a day for 3 weeks
16211791|NCT01301989|Behavioral|Sleep Counselor Intervention|Families in the sleep counselor arm of the study will receive 3 scheduled home visits by a trained sleep counselor during the first 3 months following enrollment. Two optional home visits may be scheduled to help families encountering ongoing barriers to improving their child's sleep. The intervention will be provided by trained, bilingual, culturally competent sleep counselors, who will assess home sleep conditions, work with the family to teach them how to improve sleep hygiene and the sleep environment, provide equipment as needed to improve the sleep environment (e.g. nightlight, inflatable bed, window shade, etc.) and guide the family to begin setting goals and making decisions to initiate and sustain behavioral and environmental changes to improve sleep.
16211792|NCT01301989|Other|Sleep Education Control|"The control group will receive a low intensity intervention that provides information about sleep and the benefits of adequate sleep. We will give parents the National Sleep Foundation's handout, Information about Children's Sleep for Parents and Teachers"
16211793|NCT01301963|Drug|plerixafor|Given SC
16211794|NCT01301963|Biological|filgrastim|Given SC
16211795|NCT01301950|Other|Custom Patient Instrumentation|TruMatch® Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation (CPI). TruMatch™ is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patient's distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon
16211796|NCT01301950|Other|Conventional Instruments|Total Knee Arthroplasty implanted using conventional instruments (non-CPI) and surgical technique.
16211797|NCT01301937|Drug|Meglumine antimoniate|"Meglumine antimoniate (Aventis, São Paulo, Brazil) is stored and ministered under actual conditions employed by the health services in Brazil. Each patient will be included in one of two treatment groups with meglumine antimoniate IM:
~High continuous dose: 20 mg/kg/day for 30 continuous days.
~Low continuous dose 5 mg/kg/day for up to 120 continuous days.
~There will be no cross-over between the groups for the purpose of this study. The data from those patients who require permanent discontinuation of a scheme will be assessed in the group that were randomized, ie, by intention to treat
~Arms: High continuous dose, Low continuous dose"
16211798|NCT01301924|Drug|Meglumine antimoniate|"Meglumine antimoniate is stored and ministered under actual conditions employed by health services in Brazil. Each patient will be included in one of the treatment groups with meglumine antimoniate IM:
~High dose: 20 days of 20 mg/kg/day antimoniate meglumine. Low dose: 30 days of 5 mg/kg/day antimoniate meglumine."
16211799|NCT01301911|Drug|Cipatinib|Cipatinib either at 200, 400, 800, 1200, 1400, 1600 or 1800 mg, p.o. once daily
16211800|NCT01301898|Drug|GC1111_0.5mg/kg|
16211801|NCT01301898|Drug|GC1111_1.0mg/kg|
16211802|NCT01301898|Drug|Elaprase_0.5mg/kg|
16211803|NCT01301885|Procedure|Laparoscopy/laparotomy|Surgical treatment of endometriosis (laparotomy/laparoscopy) or laparoscopic sterilisation. Sample collection in both groups.
16211804|NCT01301872|Other|check biomarker :RAGE|We will check RAGE for all patients who have ARDS included in our study
16211805|NCT01301859|Behavioral|TIP|Treatment visits as usual with MD
16211806|NCT01301833|Drug|teneligliptin|
16211807|NCT01301833|Drug|glinide|
16211808|NCT01301833|Drug|biguanide|
16211809|NCT01301833|Drug|alpha-glucosidase inhibitor|
16211810|NCT01301820|Drug|azacitidine|azacitidine sc 75 mg/m²/d (d1- d7)
16211811|NCT01301820|Drug|Lenalidomide|lenalidomide 10mg/d (d1- d21)
16211812|NCT01301807|Drug|Carfilzomib|Given IV
16211813|NCT01301807|Drug|Panobinostat|Given PO
16211814|NCT01301794|Dietary Supplement|Omega 3 fatty acid (Lovaza)|Lovaza is an FDA approved omega 3 fatty acid taken as 4 grams a day (two one gram formulations twice a day).
16211815|NCT01301781|Drug|BLI801|BLI801 laxative - oral solution
16211816|NCT01301781|Drug|Placebo|BLI801 placebo - oral solution
16211817|NCT01301768|Other|Group Education|Group educational workshops about dietary habits in the first trimester because it is when organogenesis occurs and therefore when the iodine deficiency in the mother is an important risk in the development of the fetal central nervous system.
16211818|NCT01301755|Procedure|Lung aspiration|direct lung tissue Aspergillus galactomannan antigen detection from aspirate by ultrasound-guided fine needle aspiration
16211819|NCT01301742|Drug|BI 10773|1 tablet single dose BI 10773 in the morning
16211820|NCT01301742|Drug|Gemfibrozil|Gemfibrozil 600 mg bid for 5 days
16211821|NCT01301742|Drug|BI 10773|1 tablet single dose BI 10773 in the morning
16211822|NCT01301729|Drug|Docetaxel|100 mg/m2 iv every 3 weeks, 6 cycles (18 weeks)
16211823|NCT01301729|Drug|Paclitaxel|90 mg/kg iv (+/-10%) every 3 weeks for 6 3-week cycles (18 weeks)
16211824|NCT01301729|Drug|Trastuzumab|4 mg/kg iv loading dose on Day 1, 2 mg/kg iv on Day 8 and weekly thereafter
16211825|NCT01301716|Drug|GDC-0980|Oral escalating dose
16211826|NCT01301716|Drug|bevacizumab|Intravenous repeating dose
16211827|NCT01301716|Drug|carboplatin|Intravenous repeating dose
16211828|NCT01301716|Drug|cisplatin|intravenous repeating dose
16211829|NCT01301716|Drug|paclitaxel|Intravenous repeating dose
16211830|NCT01301716|Drug|pemetrexed|intravenous repeating dose
16211831|NCT01301703|Biological|Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed)|a single 0.5-mL intramuscular injection into the deltoid muscle of the upper arm
16211832|NCT01301677|Drug|Hydrocortisone|Hydrocortisone liquid formulation
16211833|NCT01301677|Drug|2PX+|strontium chloride hexahydrate in a penetration enhancing vehicle
16211834|NCT01301677|Drug|2PX-|strontium chloride hexahydrate without a penetration enhancing vehicle
16211835|NCT01301664|Other|total knee / hip replacement|Human cartilage tissues were harvested from osteoarthritic patient during total knee arthroplasty surgery.
16211836|NCT01301651|Behavioral|balance training|30 minute each time, 2 times per week for 6 weeks.
16211837|NCT01301625|Device|MitraClip Implant|Percutaneous mitral valve repair using MitraClip implant.
16211838|NCT01301612|Drug|Nimotuzumab|Nimotuzumab, 200 mg, IV, Weekly doses for 14 weeks
16211839|NCT01301612|Drug|Cisplatin|Cisplatin, 40 mg/m2, IV, Weekly doses for 6 weeks
16211840|NCT01301612|Radiation|Brachytherapy|"Brachytherapy: 40 Gy at spot A(low dose rate, Intracavitary, 1 or 2 separate fractions for 1 to 3 weeks.
~Brachytherapy: 28 Gy at spot A (high dose rate), Intracavitary 4 fractions of 7.0 Gy once or twice a week."
16211841|NCT01301612|Drug|Cisplatin|Cisplatin, 40 mg/m2, IV. Weekly doses for 6 weeks
16211842|NCT01301612|Radiation|Radiation Therapy|"Pelvic radiation therapy: 45 Gy, External, Fractions of 1.8 Gy per day, 5 days a week.
~Dose boosts: 15 Gy ± 5%, External, Daily fractions of 1.8 Gy or 2 Gy per day, 5 days a week.
~Brachytherapy 40 Gy at spot A(low dose rate.) Intracavitary 1 or 2 separate fractions for 1 to 3 weeks.
~28 Gy at spot A (high dose rate, Intracavitary, 4 fractions of 7.0 Gy once or twice a week"
16211843|NCT01301599|Drug|combination therapy|alpha blocker and 5-alpha-reductase inhibitor medication
16211844|NCT01301599|Drug|alpha blocker monotherapy|alpha blocker monotherapy group
16211845|NCT01301599|Drug|5 alpha reductase inhibitor monotherapy|5 alpha reductase inhibitor monotherapy
16211846|NCT01301586|Drug|Doxycycline and S-equol|Oral doxycycline and s-equol twice a day
16211847|NCT01301586|Drug|Doxycycline|ORAL DOXYCYCLINE TWICE A DAY
16211848|NCT01301573|Biological|rAAV-GAD|
16211849|NCT01301560|Radiation|Radiosurgery|Gamma knife surgery for asymptomatic oligo-metastasis to brain from NSCLC
16211850|NCT01301560|Radiation|Observation|No local treatment
16211851|NCT01301521|Drug|water-soluble cinnamon extract (Cinnulin PF)|Will take (by mouth) 1 gelatin capsule that contains 1 gram water-soluble cinnamon extract (Cinnulin PF) once a day for 12 months plus standard of care aggressive lifestyle therapy
16211852|NCT01301508|Drug|AN2728 ointment, 2%|AN2728 ointment, 2%, applied twice daily for 6 weeks
16211853|NCT01301508|Drug|AN2898 ointment, 1%|AN2898 ointment, 1%, applied twice daily for 6 weeks
16211854|NCT01301508|Drug|AN2898 ointment vehicle|AN2898 ointment vehicle applied twice daily for 6 weeks
16211855|NCT01301508|Drug|AN2728 ointment vehicle|AN2728 ointment vehicle applied twice daily for 6 weeks
16211856|NCT01301495|Device|HANAROSTENT TM covered Esophageal Stent|HANAROSTENT covered Esophageal Stent for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and or extrinsic malignant tumors only and occlusion of concurrent esophageal fistula
16211857|NCT01301482|Device|Ear Acupuncture|Ear acupuncture utilizes up to 10 needles (see figure 6). If at any point the subject decides not to continue with the placing of the needles, the acupuncture will cease and the number of points will be documented. The ear Acupuncture points on the right ear include Cingulate gyrus, thalamus, omega 2, shen-men, point zero. The ear Acupuncture points on the left ear include Cingulate gyrus, thalamus, omega 2, shen-men, point zero (see figures 1-5).
16211858|NCT01301469|Drug|6% HES 130/0.42 in plasma adapted Ringer's solution|60 g/l hydroxyethyl starch 130 dissolved in plasma adapted Ringer's solution (balanced solution)
16211859|NCT01301469|Drug|6% HES 130/0.4 in a saline solution|60 g/l Hydroxyethyl starch (HES) with a mean molecular weight of 130 kDalton which is dissolved in a saline solution
16211860|NCT01301456|Biological|Placebo|Single subcutaneous injection of placebo
16211861|NCT01301456|Biological|PF-04856883|Single subcutaneous injection of PF-04856883
16211862|NCT01301456|Biological|PF-04856883|Single subcutaneous injection of PF-04856883
16211863|NCT01301456|Biological|PF-04856883|Single subcutaneous injection of PF-04856883
16211864|NCT01301456|Biological|Placebo|Single subcutaneous injection of placebo
16211865|NCT01301456|Biological|PF-04856883|Single subcutaneous injection of PF-04856883
16211866|NCT01301456|Biological|PF-04856883|Single subcutaneous injection of PF-04856883
16211867|NCT01301456|Biological|PF-04856883|Single subcutaneous injection of PF-04856883
16211868|NCT01301456|Biological|Placebo|Multiple weekly subcutaneous injections of placebo for 3 weeks
16211869|NCT01301456|Biological|PF-04856883|Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
16211870|NCT01301456|Biological|PF-04856883|Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
16211871|NCT01301456|Biological|PF-04856883|Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
16211872|NCT01301456|Biological|PF-04856883|Multiple weekly subcutaneous injections of PF-04856883 for 3 weeks
16211873|NCT01301443|Drug|Subretinally injected RetinoStat|Single subretinal injections, with increasing doses. 9 patients with 3 patients at each dose followed, by 12 patients at maximum tolerated dose.
16211874|NCT01301430|Drug|H-1PV|H-1PV administered at three increasing doses either intratumorally or intravenously and then 10 days after the first administration intracerebrally (into the walls of tumor resection cavity).
16211875|NCT01301417|Device|ColonRing™|Creation of a circular Compression Anastomosis
16211876|NCT01301404|Dietary Supplement|10% carbohydrate drink|In the study group, 10% carbohydrate drink 400 ml will be given between 18-24 hr the night before surgery and another 400 ml will be drunk at 6-7 hr in the morning of surgery.
16211877|NCT01301391|Drug|Milciclib Maleate|"150 mg/day once daily, for 7 consecutive days (days 1 to 7) followed by 7 days of rest (days 8 to 14) in a 2-week cycle.
~Number of cycles: until disease progression or unacceptable toxicity."
16211878|NCT01301378|Procedure|Molteno 3 glaucoma drainage shunt|Patients needing glaucoma drainage surgery
16211879|NCT01301352|Other|Route of feeding (nasogastric vs. nasojejunal)|Safety and efficacy of feeding nasogastrically vs. nasojejunally while receiving noninvasive positive pressure ventilation
16211880|NCT01301326|Device|subthreshold and threshold laser treatment|subthreshold laser treatment
16211881|NCT01301326|Device|Threshold laser treatment|threshold laser treatment
16211882|NCT01301313|Drug|Levosimendan|Levosimendan 2.5 mg / ml ampoules. The drug will be administrated in continuous intravenous perfusion in a single dose of 0.1 - 0.2 micrograms/ kg / min for 24 hours.
16211883|NCT01301313|Drug|Conventional intensified inotropic treatment|Increasing the dose and / or the number of inotropes (dopamine and / or dobutamine and / or milrinone and / or adrenaline)
16211884|NCT01301300|Device|Disinfecting Cap|Replace standard practice with using the disinfecting cap
16211885|NCT01301287|Drug|Chlorella|
16211886|NCT01301274|Drug|hypotonic|0.45% NaCl/5% dextrose IV maintenance fluids
16211887|NCT01301274|Drug|isotonic|0.9% NaCl/5% dextrose IV maintenance fluids
16211888|NCT01301261|Drug|sugammadex|Sugammadex 2 mg/kg when a two count of train of four appears
16211889|NCT01301261|Drug|Sugammadex 4 mg/kg|Sugammadex 4 mg/kg are given when a posttetanic count 1-3 appears
16211890|NCT01301261|Drug|Sugammadex 16mg/kg|Sugammadex 16 mg/kg three minutes after the injection of cis-atracurium
16211891|NCT01301248|Other|Chemoradiation plus Cetuximab|Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2)concurrently with weekly cetuximab 250mg/m2 (following initial loading dose of 400mg/m2 a week before radiotherapy initiation)
16211892|NCT01301248|Other|Chemoradiation|Radiotherapy 65-70 Gy (1.8 Gy fractionation) Chemotherapy delivered weekly (cisplatin; 40mg/m2
16211893|NCT01301222|Drug|Inj. Octreotide|100 mcg subcutaneously for 5 days
16211894|NCT01301196|Behavioral|Educational workshop|3h attendance at educational workshop plus self-monitoring
16211895|NCT01301183|Drug|RhIGF-1 with transdermal 17-beta estradiol|"RhIGF-1 will be started at a dose of 30mcg/k/dose twice daily, and will be titrated up or down in 25% dose increments to maintain IGF-1 levels in the upper half of the normal range.
~Estradiol will be delivered transdermally using a 100 mcg patch (Vivelle Dot) changed twice weekly. Subjects will receive cyclic micronized progesterone (Prometrium) 100 mg daily for the first 10 days of each month. All subjects will receive supplemental calcium and vitamin D."
16211896|NCT01301183|Drug|Placebo and transdermal 17-beta estradiol|Placebo injections will be administered twice daily. Estradiol will be delivered transdermally using a patch (100 mcg) changed twice weekly. Subjects will receive cyclic micronized progesterone (Prometrium) 100 mg daily for the first 10 days of each month. All subjects will receive supplemental calcium and vitamin D.
16211897|NCT01301170|Procedure|dry needling|The needling will take place bilaterally at both the suboccipital region and the paravertebral muscles between C4 and T4. The needling will take place with the patient in the prone position. Following all needle placement, they will rotated clockwise till the point that tension on the needle is felt by the therapist. This will create more tension between the needle and tissue fibers, after which the needles were removed.
16211898|NCT01301157|Drug|M518101|Proper quantity twice a day
16211899|NCT01301157|Drug|placebo|Proper quantity twice a day
16211900|NCT01301157|Drug|Dovonex|Proper quantity twice a day
16211901|NCT01301131|Other|Probiotics|80 ml of fermented dairy product containing L. casei shirota via nasogastric tube once daily and 80 ml of fermented dairy product containing L. casei shirota oral rinse once daily
16211902|NCT01301131|Other|control|usual oral care
16211903|NCT01301105|Behavioral|Mindfulness Based Stress Reduction (MBSR)|8 week class in stress reduction through instruction in mindfulness related techniques.
16211904|NCT01301105|Behavioral|Health Enhancement Program (HEP)|8-week intervention designed to be structurally equivalent to MBSR but without a mindfulness component. Consists of nutrition, functional movement, physical activity, and music therapy.
16211905|NCT01301092|Biological|LY2189265|administered intravenous, subcutaneous or intramuscular
16211906|NCT01301079|Drug|Ketamine|Patients in group ketamine was administrated ketamine (5mcg/kg/min) during the surgery.
16211907|NCT01301079|Drug|Saline|Patients in group N (placebo) was administrated saline during surgery.
16211908|NCT01301066|Drug|Pitavastatin|Pitavastatin 4 mg QD
16211909|NCT01301066|Drug|Pravastatin|Pravastatin 40 mg QD
16211910|NCT01301053|Other|Current UVA intensive care insulin protocol|Current UVA intensive care insulin protocol used for insulin management for 12 hours
16211911|NCT01301053|Other|"Current UVA intensive care insulin protocol with brakes"|"Current UVA intensive care insulin protocol for insulin management with the addition of brakes which reduces insulin administration based on continuous glucose monitoring data between hourly reference glucose data to reduce episodes of hypoglycemia (blood glucose <70 mg/dl)and severe hypoglycemia (blood glucose<50 mg/dl)."
16211912|NCT01301040|Drug|epirubicin, cyclophosphamide, docetaxel|"Treatment arm 1: EC - epirubicin (100mg/m2 IV) and cyclophosphamide (600mg/m2 IV) every 3 weeks for 4 cycles.
~Treatment Arm 2: TC - docetaxel (75mg/m2 IV) and cyclophosphamide (600mg/m2 IV) every 3 weeks for 4 cycles."
16211913|NCT01301027|Drug|Pioglitazone|15mg/day pioglitazone for 2 weeks, then 30mg/day pioglitazone for the remaining 24 weeks
16211914|NCT01301027|Drug|Placebo|1 pill a day for 26 weeks
16211915|NCT01301001|Drug|Placebo oral capsule|Placebo 2 capsules am and 3 capsules pm
16211916|NCT01301001|Drug|Gabapentin|Gabapentin 1200 mg am and 1800 mg pm
16211917|NCT01300988|Drug|Aprepitant|Aprepitant (Emend®) 375 mg daily for 14 days
16211918|NCT01300988|Drug|Aprepitant placebo|Aprepitant(Emend®) placebo for 14 days
16211919|NCT01300975|Drug|pentavalent antimony|3 intralesional injections of antimony at D1, D3 and D7
16211920|NCT01300975|Procedure|cryotherapy|Frozing of lesions with liquid nitrogen ad D1 and D14
16211921|NCT01300975|Drug|placebo cream|topical emollient crean 3 times a day during 21 days
16211922|NCT01300962|Drug|BMK120|BKM120 PO 50, 80 or 100mg every day for each day of each 21 day cycle. Number of cycles: until progression of disease; unacceptable toxicity, withdrawal or death.
16211923|NCT01300962|Drug|Capecitabine|875-1250mg/m2 PO BID for two weeks followed by one week rest every three week cycle. Number of cycles: until progression of disease, unacceptable toxicity, withdrawal or death.
16211924|NCT01300962|Drug|BYL719|BYL719 200mg PO BID for 21 days (3 weeks) in combination with capecitabine 1000 mg/m2 PO BID for 2 weeks
16211925|NCT01300962|Drug|Trastuzumab|trastuzumab infusion on day 1 of each cycle.
16211926|NCT01300962|Drug|Lapatinib|lapatinib daily for 21 days in each cycle.
16211927|NCT01300949|Diagnostic Test|Spaeth/Richman Contrast Sensitivity Test|internet based computerized contrast sensitivity test measuring central and peripheral vision using black and white stripes that decrease in contrast by fading to a white background.
16211928|NCT01300949|Diagnostic Test|Pelli-Robson Contrast Sensitivity Chart|wall chart contrast sensitivity test measuring central vision using black letters that decrease in contrast by fading to a white background.
16211929|NCT01300923|Drug|Acamprosate|
16211955|NCT01300715|Procedure|lumbar medial branch radiofrequency neurotomy|the classic tunnel vision technique versus the alternative technique
16211989|NCT01300403|Other|Control|Patients were instructed to stay comfortably seated during 15 minutes. After this period they were stimulated to cough during a five minutes period.
16212036|NCT01300026|Drug|AMG 319|AMG 319 is a highly selective, orally bioavailable and potent small molecule inhibitor of PI3Kδ.
16211930|NCT01300910|Device|Shang Ring|The Shang Ring is a sterile device consisting of two concentric medical grade plastic rings: an inner ring with a silicone band and an outer, hinged ring. The inner ring fits inside the outer ring which will lock when snapped together. The Shang Ring comes in multiple sizes. The appropriate size is determined through use of a measuring strip. To ensure that men cannot remove the device prematurely, the locking mechanism must be broken open using a tool that is similar to a scalpel handle. Then, a pair of special scissors, specifically designed for this purpose, is used to remove the inner ring after healing
16211931|NCT01300910|Procedure|Male circumcision|A conventional surgical procedure will be performed, per WHO recommendations, involving: drawing a line to mark the amount of foreskin to be cut; cutting off the foreskin; hemostasis; and wound closure with sutures.
16211932|NCT01300897|Procedure|Cortical Evoked Potentials|A probe with 2 ring electrodes is placed in the anorectum. A small amount of electric current is passed separately through the anal and rectal electrodes.. The cortical evoked potentials from the anal and rectal sites are measured.
16211933|NCT01300897|Procedure|Transcranial motor evoked potentials|A probe with 2 ring electrodes is placed in the anorectum. A magnetic coil is placed on the scalp at the anorectal site on each side, and discharged using magnetic energy. The motor evoked potentials at the anal and rectal sites are measured.
16211934|NCT01300897|Procedure|Translumbosacral motor evoked potentials|A probe with 2 ring electrodes is placed in the anorectum. A magnetic coil is placed on the back at the lumbar plexus and sacral plexus levels and discharged using magnetic energy. The motor evoked potentials at the anal and rectal sites are measured.
16211935|NCT01300858|Drug|EGEN-001-301|Patients will be treated with EGEN-001 intra-peritoneally (IP) once every week for 12 weeks and then once every two weeks until disease progression or intolerable toxicity, but for no more than one year. Patients who develop progressive metastases will receive standard chemotherapy concomitant with EGEN-001. Hence, the initial EGEN-001 treatment period will be without chemotherapy. The standard chemotherapy regimen will be FOLFOX or FOLFIRI administered every 2-3 weeks. Patient with progressive disease a second time will be taken off-study. Those who remain progression-free will receive EGEN-001 for up to one year.
16211936|NCT01300845|Procedure|Humidification|From randomization, oxygen therapy is humidified
16211937|NCT01300845|Procedure|No Humidification|oxygen therapy is never humidified
16211939|NCT01300819|Other|Placebo|"Placebo patches of 2, 4, 6 & 8 mg / 24 hours Daily application of Placebo patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose was up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose was reached. Maximal dose was 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
~Optimal or maximal dose was maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
16211940|NCT01300819|Drug|Rotigotine|"Rotigotine patches of 2, 4, 6, and 8 mg / 24 hours
~Once daily application of Rotigotine patches starting at 2 mg / 24 hours (early Parkinson's Disease (PD) patients) or 4 mg / 24 hours (advanced PD patients). Dose was up-titrated in weekly increments of 2 mg / 24 hours until optimal or maximal dose was reached. Maximal dose is 8 mg / 24 hours for early PD patients and 16 mg / 24 hours for advanced PD patients.
~Optimal or maximal dose was maintained for 12 weeks followed by a de-escalation by 2 mg / 24 hours every other day."
16211941|NCT01300793|Drug|Velcade (bortezomib), rituximab, ifosfamide, carboplatin, etoposide|Rituximab, 375 mg/m2, IV on day 1 Etoposide, 100 mg/m2, IV on days 2 to 4 Carboplatin, AUC 5 (using the Calvert Formula), IV on day 3 Ifosfamide, 5 g/m2 with Mesna 5 g/m2, CIV over 24 hours beginning D. 3 Bortezomib,1.0mg/m2 starting cohort. Based upon a satisfactory safety profile, additional pts. will be enrolled into the 1.3, 1.5 and 1.7mg/m2 cohorts given IVP over 3 sec. d. 1, 4, 8 & 11 q. 28 days.
16211942|NCT01300780|Drug|Etoricoxib|Group 2 - experimental Etoricoxib will receive two doses of selective anti-inflammatory to enzyme cyclooxygenase 2 (COX-2) (Etoricoxib 60 mg) given once every 24 hours;
16211943|NCT01300780|Other|Placebo|Group 1 - Control Group will receive two doses of placebo tablet administered a every 8 hours,
16211944|NCT01300767|Device|Lotrafilcon B contact lens (AIR OPTIX® AQUA)|Silicone hydrogel, single vision contact lens worn in one eye in a daily wear modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
16211945|NCT01300767|Device|Balafilcon A contact lens (PureVision® 2)|Silicone hydrogel, single vision contact lens worn in one eye in a daily wear modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
16211946|NCT01300767|Device|Contact lens solution (Clear Care®)|Hydrogen peroxide-based system used for cleaning, disinfection and overnight storage of the study contact lenses.
16211947|NCT01300754|Procedure|Dextrose Injection|12.5 Dextrose in 1% Lidocaine injected monthly for 3 months with a 27 gauge needle on painful areas of the tibial tuberosity, under the patellar tendon.
16211948|NCT01300754|Procedure|Lidocaine Injection|1% Lidocaine injected monthly for 3 months with a 27 gauge needle on painful areas of the tibial tuberosity, under the patellar tendon.
16211949|NCT01300754|Other|Usual Care|Therapist supervised exercises that are standard of care for Osgood-Schatter Disease as well as relative rest and gradual resumption of pain-limited sport.
16211950|NCT01300741|Device|Lotrafilcon B contact lens (AIR OPTIX® AQUA)|Silicone hydrogel, single vision contact lens worn in one eye in a daily wear modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
16211951|NCT01300741|Device|Galyfilcon A contact lens (ACUVUE® ADVANCE® Plus)|Silicone hydrogel, single vision contact lens worn in one eye in a daily wear modality for approximately 5 days or more per week, at least 10 hours per day, for up to 4 weeks.
16211952|NCT01300741|Device|Contact lens solution (Clear Care®)|Hydrogen peroxide-based system used for cleaning, disinfection and overnight storage of the study contact lenses.
16211953|NCT01300728|Drug|NewGam 10% IVIG|"Subjects will be randomized to receive either an infusion of IVIG at 0.4 g/kg or every 14 days for two months for a total of five infusions.
~Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio. Twenty-five subjects will receive IVIG and 25 subjects will receive placebo."
16211954|NCT01300728|Other|Placebo|Subjects will be randomized to receive either an infusion of 0.9% saline solution (placebo) every 14 days for two months for a total of five infusions. Fifty subjects will be enrolled and randomized in a 1:1 IVIG 2.0 g/kg: placebo ratio.
16211956|NCT01300676|Drug|Tualang honey|"This was a randomized, prospective, clinical study to evaluate the effect of Tualang honey in comparison with HRT. Subjects will be confined to healthy postmenopausal women who were naturally menopause for more than one year. The study period was four months. A total of 79 patients were recruited.
~Group 1: Subjects receiving 20 g/day of Tualang honey. The honey used was from a single batch honey supplied by Federal Agricultural Marketing Authorities (FAMA), Malaysia, evaporated by FAMA to achieve a water content of about 20%, submitted to Sterile Gamma company at Shah Alam, Selangor for sterilization at 25 kGy and packed in 20 g sachet in collaboration with School of Pharmaceutical Sciences laboratory.
~Group 2: Subjects receiving hormonal replacement therapy (Femoston®), also known as Femo conti 1/5 (contain 1 mg Estradiol valerate and 5 mg Dydrogesterone) supplied by Solvay Pharma Malaysia."
16211957|NCT01300650|Drug|Anakinra|Anakinra 100 mg subcutaneous injection daily
16211958|NCT01300637|Drug|Metformin|metformin 500 mg/pill; target dose 1500 mg/day for 24 weeks
16211959|NCT01300637|Drug|placebo|identical-appearing pill of placebo
16211960|NCT01300624|Behavioral|Verb Network Strengthening Treatment|Treatment to improve word retrieval in sentences and discourse for persons with aphasia due to stroke.
16211961|NCT01300611|Drug|TXA127 300 mcg/kg/day|Injection, 300 mcg/kg/day for 28 days
16211962|NCT01300611|Drug|TXA127 1000 mcg/kg/day|Injection, 1000 mcg/kg/day for 28 days
16211963|NCT01300598|Procedure|Autologous Adipose Tissue derived MSCs Transplantation|Intra-articular infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 1x10e7 cells/3mL,5x10e7 cells/3mL, 1x10e8 cells/3mL
16211964|NCT01300585|Other|MRI|Patients who qualify for the study and consent to be included will undergo placement of areola and nipple markers that will be held in place with tape for the duration of the ordered MRI study. The markers consist of latex-free plastic tubing filled with vegetable based hydrogenated oil that is solid at room temperature. This creates a fat density marker that will define the areola but does not interfere with or create artifact onto the underlying tissue. The marker can be placed by the investigator or available MRI technician instructed in marker placement. The patient will then undergo the MRI. The patients participation in the study will end with the MRI.
16211965|NCT01300572|Procedure|Allogeneic Bone Marrow Transplantation|Undergo allogeneic bone marrow transplant
16211966|NCT01300572|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic PBSC or bone marrow transplant
16211967|NCT01300572|Drug|Cyclosporine|Given PO or IV
16211968|NCT01300572|Drug|Fludarabine Phosphate|Given IV
16211969|NCT01300572|Biological|Indium In 111 Anti-CD45 Monoclonal Antibody BC8|Given IV (dosimetric dose)
16211970|NCT01300572|Other|Laboratory Biomarker Analysis|Correlative studies
16211971|NCT01300572|Drug|Mycophenolate Mofetil|Given PO or IV
16211972|NCT01300572|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo allogeneic PBSC transplant
16211973|NCT01300572|Other|Pharmacological Study|Correlative studies
16211974|NCT01300572|Radiation|Total-Body Irradiation|Undergo TBI
16211975|NCT01300572|Radiation|Yttrium Y 90 Anti-CD45 Monoclonal Antibody BC8|Given via central line (therapeutic dose)
16211976|NCT01300559|Device|Tissuelink device|Tissuelink device plus Unipolar electrocautery
16211977|NCT01300546|Drug|Sumatriptan/Naproxen Sodium|Each tablet of Treximet for oral administration contains Sumatriptan 85mg / Naproxen Sodium 500mg. Study medication is to be administered within 1 hour of migraine onset on 14 or fewer days per month in the Treatment Period.
16211978|NCT01300546|Drug|Naproxen Sodium|Each tablet of Naproxen Sodium for oral administration is provided in 500mg tablet. Study medication is to be administered within 1 hour of migraine onset on 14 or fewer days per month in the Treatment Period.
16211979|NCT01300533|Drug|BIND-014|
16211980|NCT01300520|Device|Target Tape|Comparing procedures using Target Tape against procedures not using Target Tape
16211981|NCT01300468|Drug|PHA-848125AC|
16211982|NCT01300455|Drug|Suvorexant|40 mg tablets, orally once daily for 4 consecutive days in the evening
16211983|NCT01300455|Drug|Matching Placebo|Placebo tablets, orally once daily for 4 consecutive days in the evening
16211984|NCT01300442|Other|TEDS in COPD patients|For the TEDS (transcutaneous electrical diaphragmatic stimulation) the electrical current is pulsed, biphasic and symmetric, with the following parameters: frequency of 30 Hertz; 0.4ms phase width, rise time of 0.7 seconds; respiratory rate of 14 rpm; intensity is the minimum necessary to obtain diaphragm muscle contraction. Four silicone-carbon electrodes (3x5cm) were placed on the skin with gel and micropore tape. Two electrodes were located on each side of the thorax, specifically in the 3rd intercostal space near the xyphoid region and in the 7th intercostal space, on the mid-axillary line. Each session had duration of approximately 30 minutes and the subjects were instructed to co-ordinate breathing with the pulsing of the electrical current.
16211985|NCT01300442|Other|TEDS in healthy patients|For the TEDS (transcutaneous electrical diaphragmatic stimulation) the electrical current is pulsed, biphasic and symmetric, with the following parameters: frequency of 30 Hertz; 0.4ms phase width, rise time of 0.7 seconds; respiratory rate of 14 rpm; intensity is the minimum necessary to obtain diaphragm muscle contraction. Four silicone-carbon electrodes (3x5cm) were placed on the skin with gel and micropore tape. Two electrodes were located on each side of the thorax, specifically in the 3rd intercostal space near the xyphoid region and in the 7th intercostal space, on the mid-axillary line. Each session had duration of approximately 30 minutes and the subjects were instructed to co-ordinate breathing with the pulsing of the electrical current.
16211986|NCT01300429|Genetic|obtain tissue specimens|One core biopsy specimen will be placed in formalin and processed for cytogenetic and FISH analyses as well as DNA for ALK sequencing. The second core biopsy specimen will be immediately frozen in liquid nitrogen and stored in a -80 degree freezer for research specimen. Collection will be performed on-site at the time of the procedure.
16211987|NCT01300403|Other|Flutter valve|Flutter valve is a physiotherapy device commonly used for the treatment of pulmonary hypersecretive conditions. The patients is taught to exhale through the device, producing positive expiratory pressure and flow oscillations. In this study the intervention took 15 minutes. During this period the patients were free to cough.
16211988|NCT01300403|Other|expiration with the glottis open in lateral posture (ELTGOL)|This technique is a maneuver of slow expiration with the glottis open, with the subject in lateral posture. The patients performed three sets of 10 repetitions in left and right lateral decubitus.
16212037|NCT01300013|Drug|Placebo|48-hour infusion of placebo
16211990|NCT01300377|Drug|Bupivacaine / Lidocaine|5cc 1% Lidocaine solution mixed with 5 cc 0.25% Bupivacaine solution administered locally to the surgical site at time of the surgical procedure. Administered once only.
16211991|NCT01300377|Drug|Lidocaine|10 cc 1% solution administered locally to the surgical site at time of surgical procedure. Administered once only.
16211992|NCT01300364|Drug|Reboxetine|8mg/day.
16211993|NCT01300364|Drug|citalopram (SSRI)|30mg/day
16211994|NCT01300351|Drug|Fulvestrant|Fulvestrant was supplied as a castor oil based solution in clear neutral glass pre-filled syringes. Each syringe will contain 250 mg of fulvestrant in 5 ml.
16211995|NCT01300351|Drug|Placebo|Matching placebo was supplied as a castor oil based solution in clear neutral glass prefilled syringes. Each syringe will contain 5 ml.
16211996|NCT01300338|Device|Blood pressure monitor with telemetry|Blood pressure monitor for home use with readings uploaded to a web server viewable by the diabetes care manager
16211997|NCT01300338|Device|Home blood pressure monitor without telemetry|Self monitor of blood pressure without telemetry
16211998|NCT01300325|Other|3% hypertonic saline solution|Patients receive every 6 hours the nebulized 0.9% saline (Placebo comparator) (group I) or the 3% hypertonic saline solution group II) in addition to aerosolized epinephrine (1.5 mg) and to the conventional treatment (oxygen, fluids).
16211999|NCT01300312|Drug|Eperisone hydrochloride and Diclofenac sodium|Fixed dose capsule formulation of eperisone hydrochloride 50 mg plus diclofenac sodium 50 mg to be given 3 times a day after meals for 7 to 10 days
16212000|NCT01300312|Drug|Eperisone hydrochloride|eperisone hydrochloride 50 mg as tablet formulation to be given 3 times daily after meals for 7 to 10 days
16212001|NCT01300299|Radiation|Stereotactic Body Radiation Therapy|12 Gray (Gy) x 4 fractions (48 Gy) will be delivered to peripherally located tumors (> 2 cm in all directions around the proximal bronchial tree and centrally located tumors (within <2 centimeters (cm) of proximal bronchial tree). Treatment should be given on consecutive days. There will be 4 or 5 treatments.
16212002|NCT01300286|Drug|RiaSTAP|One time dose of 70 mg/kg will be administered intravenously.
16212003|NCT01300273|Dietary Supplement|Compound α-Ketoacid Tablet|30 patients will be treated with a LPD containing 0.6g protein/kg BW per day and 120-125 kJ/kg BW per day and supplemented with keto-amino acids (Ketosteril®, Fresenius Kabi) at a dosage of 100 mg/kg BW per day.
16212004|NCT01300260|Biological|LY2189265|Administered subcutaneously
16212005|NCT01300260|Drug|Placebo|Administered subcutaneously
16212006|NCT01300260|Drug|Insulin|Administered intravenously
16212007|NCT01300260|Drug|Glucose|Administered intravenously
16212008|NCT01300260|Drug|Glucagon|Administered intravenously
16212009|NCT01300247|Drug|Fludarabine|Participants will receive 6 cycles (each 28-day cycle) of fludarabine at dose of 25 mg/m^2 IV, on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6.
16212010|NCT01300247|Drug|Obinutuzumab|Participants will receive 6 cycles (each 28-day cycle) of obinutuzumab at dose of 1000 mg IV infusion, on Days 1, 8 and 15 of Cycle 1 and Day 1 of Cycles 2-6.
16212011|NCT01300247|Drug|Bendamustine|Participants will receive 6 cycles (each 28-day cycle) of bendamustine at dose of 90 mg/m^2 IV, on Days 2 and 3 of Cycle 1 and Days 1 and 2 of Cycles 2-6.
16212012|NCT01300247|Drug|Cyclophosphamide|Participants will receive 6 cycles (each 28-day cycle) of cyclophosphamide at dose of 250 mg/m^2 IV on Days 2, 3 and 4 of Cycle 1 and Days 1, 2 and 3 of Cycles 2-6.
16212013|NCT01300234|Drug|Tenofovir disoproxil fumarate (TDF) tablets|white, almond-shaped, film-coated tablets containing 300mg of TDF
16212014|NCT01300234|Drug|Adefovir dipivoxil (ADV) tablets|white to off-white, round, biconvex tablets containing 10mg of ADV
16212015|NCT01300208|Drug|CC-11050|Cohort 1: 50 milligrams twice per day for 4 weeks Cohort 2: 100 milligrams twice per day for 8 weeks Cohort 3: 200 milligrams twice per day for 12 week
16212016|NCT01300208|Other|Placebo|
16212017|NCT01300182|Other|Whole body vibration therapy|The WBVT will be carried out in a vibration plates operated in vertical direction. The frequency of that vibration can be adjusted step of 5Hz with vibration frequency ranges from 20Hz to 60Hz. The amplitude can be set as 4mm.
16212018|NCT01300182|Other|Control|Conventional post-operative physical therapy exercises and rehabilitation.
16212019|NCT01300169|Behavioral|The Collaborative Assessment and Management of Suicidality|"Intensive outpatient, suicide-focused, psychotherapy designed to target and treat the drivers of suicidal ideation and behaviors."
16212020|NCT01300169|Behavioral|Enhanced Care as Usual|This is just standard outpatient mental health care that is routinely provided in the study site outpatient clinic
16212021|NCT01300156|Drug|Oxaliplatin-based chemotherapy (ESHAOx)|"Etoposide 40 mg/m2, D1-4
~Methylprednisolone 500mg, D1-5
~Cytarabine 2 g/m2, D5
~Oxaliplatin 130 mg/m2, D1"
16212022|NCT01300143|Other|TACE|Control arm will be treated by 2 or 3 cures of TACE DC beads at week 0, 8 and 16 (if required)
16212023|NCT01300143|Other|TACE+ RTC|Experimental group will be treated by one cure of TACE DC Beads at week 0 then, within two weeks, by external conformational radiotherapy in 18 sessions
16212024|NCT01300130|Dietary Supplement|low docosahexaenoic acid formula|
16212025|NCT01300130|Dietary Supplement|medium docosahexaenoic acid formula|
16212026|NCT01300130|Dietary Supplement|high docosahexaenoic acid formula|
16212027|NCT01300130|Dietary Supplement|breast milk|a non randomized group of breast milk fed infants was included
16212028|NCT01300104|Behavioral|Exercise|"Prescriptions: Vigorous exercise (average 65-70% of maximal oxygen consumption) minimum 3 times 45 minutes per week according to customized endurance training programs.
~Restrictions: None."
16212029|NCT01300104|Behavioral|Whole grain rye|Prescriptions: Minimum 170-180g of whole grain rye intake per day. Restrictions: None.
16212030|NCT01300104|Behavioral|Recommendations|Recommendations on a health-promoting, energy restricted diet according to Danish Nutrition Recommendations and encouraged to walk at least 10,000 steps every day.
16212031|NCT01300078|Drug|MF101|MF101 10 g/day MF101 15 g/day
16212032|NCT01300065|Device|Experimental- Soflens|A new pair of lenses will be worn each day while the subject is in the study
16212033|NCT01300065|Device|Marketed - Soflens|A new pair of lenses will be worn each day while the subject is in the study.
16212034|NCT01300052|Drug|AN2728 ointment, 2%|AN2728 ointment, 2%, applied twice daily for 12 weeks
16212035|NCT01300052|Drug|Ointment Vehicle|Ointment Vehicle, applied twice daily for 12 weeks
16212038|NCT01300013|Drug|Omecamtiv mecarbil|48-hour infusion of omecamtiv mecarbil; dose strength will depend on cohort assignment.
16212039|NCT01300000|Other|Human Milk|ad lib
16212040|NCT01300000|Other|Investigational infant formula|ad lib
16212041|NCT01300000|Other|Milk based standard infant formula|ad lib
16212042|NCT01299987|Radiation|intraoperative radiotherapy|intraoperative single dose radiotherapy (20 Gy)
16212043|NCT01299974|Other|Parents and Residents in Session|Family Faculty members agreed to participate in meetings with pediatric residents who agree to participate. Standardized meetings include discussions of the following: 1. Impact of hospitalization on the behavior and development of each participating parent's child. 2. Effective communication with a parent 3. How to gain trust 4. The family meeting: who participates, the agenda 5. Troubleshooting: how to deal with difficult situations (the parents will present a few instances, from their own experience, which they think might be challenging to the clinicians who treated their children). Other core components will be added (or existing ones deleted) based on participants' feedback. The meeting will be attended by two residents, a family council member, and a senior faculty who will serve as monitor. Following the meeting, the residents will have an opportunity to ask questions and offer comments about the experience in a dedicated feedback interview with a senior faculty member.
16212044|NCT01299961|Drug|abatacept|125 mg once a week up to 12 months.
16212045|NCT01299948|Drug|Prednisolone|5 mg prednisolone orally per day
16212046|NCT01299935|Behavioral|Transcendental Meditation|The Transcendental Meditation program is the principal mind-body approach of Maharishi Ayurveda, originating from the ancient Vedic tradition and introduced 50 years ago by Vedic scholar and teacher Maharishi Mahesh Yogi. The Transcendental Meditation technique is described as a simple and natural procedure that is practiced 20 minutes twice a day while sitting comfortably with the eyes closed. Practice of the Transcendental Meditation technique does not require any changes in personal beliefs, philosophy or lifestyle. During the practice a unique state of restful alertness is gained. Acute and chronic physiological effects have been documented. The course is taught by instructors certified by Maharishi Foundation - USA.
16212047|NCT01299935|Behavioral|Health Education|health education is taught in a clinical setting using standard AHA recommendations for proper diet, exercise and control of substance usage but without a stress management component.
16212048|NCT01299922|Drug|cyclosporine +mycophenolic acid+prednison|Cyclosporine for 26 weeks Prednisone+mycophenolic acid 106 weeks
16212049|NCT01299922|Drug|Mycophenolic Acid + prednison|Mycophenolic Acid + prednison for 106 weeks
16212050|NCT01299909|Behavioral|Integrated Training for Smokers|8 classes in smoking cessation strategies, 2 weeks of nicotine patches, and access to the Freedom From Smoking online program
16212051|NCT01299909|Behavioral|Mindfulness Training for Smokers|8 classes of training in mindfulness meditation, 2 weeks of nicotine patches, and access to the MTS website.
16212052|NCT01299909|Behavioral|Quitline|Telephone-based smoking cessation treatment via the Wisconsin Tobacco Quit Line (WTQL) consisting of 2 weeks of nicotine patches, self-help materials, an interactive website, and unlimited follow-up calls to the WTQL at no cost.
16212053|NCT01299896|Other|Coordinated Care|CTQ coordinators will contact the participants for various information sessions about the participant's smoking. These participants will also receive our Connecting to Quit newsletter quarterly.
16212054|NCT01299896|Other|Usual Care|Standard therapy to help participants with smoking cessation.
16212055|NCT01299883|Other|Integrated vs Non-integrated Risk Education|Integrated group receives education about risk factors for both cancer and CVD whereas the non-integrated group receives information about CVD only to assess differences in health behavior outcomes.
16212056|NCT01299870|Drug|AED treatment plus placebo|Your usual AED(s) treatment with placebo for 12 weeks followed by 4 weeks washout period, and then Keishibukuryogan, (2.5 g of granulate filled in capsules) three times a day for a total of 7.5 g a day with your usual AED(s) treatment for 12 weeks.
16212057|NCT01299870|Drug|Keishibukuryogan|Keishibukuryogan, (2.5 g of granulate filled in capsules) three times a day for a total of 7.5 g a day with your usual AED(s) for 12 weeks followed by 4 weeks washout period, and then your usual AED(s) treatment with placebo for 12 weeks.
16212058|NCT01299857|Drug|Rituximab|375mg/m2
16212059|NCT01299844|Behavioral|Diabetes Peer Counseling|16 Home visits from a bilingual/bicultural diabetes peer counselor.
16212060|NCT01299831|Behavioral|72 hour fast|The participants will be fasting 72 hours prior to the start of the study day, drinking water is allowed.
16212061|NCT01299831|Behavioral|control, 12 hour fast|The 12 hour fast will be used as a basic metabolic control
16212062|NCT01299831|Drug|Growth hormone|Genotropin bolus(0,005 mg/kg over 20 min.) will be administered at the beginning of the study day after a 12 hour fast.
16212063|NCT01299831|Drug|Olbetam|"The participants will be fasting 72 hours prior to the start of the study day, drinking water is allowed.
~During the last 12 hours of fasting and the study day lipolysis will be inhibited with one tablet of olbetam 250 mg every 4 hours."
16212064|NCT01299805|Drug|Vortioxetine|Encapsulated tablet
16212065|NCT01299805|Drug|Placebo|Vortioxetine placebo-matching capsules.
16212066|NCT01299792|Other|sonographic measurement of bladder wall thickness|measurement of bladder wall thickness by ultrasound at different filling states of the bladder during urodynamic investigation
16212067|NCT01299779|Drug|PEG-SD|"PEG-SD
~Bisacodyl: two 5-mg tablets at 3 pm day prior
~1L sports drink* (labeled #1) with PEG-3350 119 gram bottle (labeled #1) at 6 pm night prior
~1L SD* (labeled #2) with PEG-3350 119 gram bottle (labeled #2) starting 4 hrs prior to colonoscopy
~Same flavor, non-red Gatorade® for all patients."
16212068|NCT01299779|Drug|PEG-ELS|"1L + 500 cc clear liquids at 6 pm night prior
~1L + 500 cc clear liquids starting 4 hours prior to colonoscopy"
16212069|NCT01299766|Behavioral|Behavioral Activation (BA)|BA is a manual-based, behavioral treatment that helps people increase activity levels through goal setting, activity scheduling, graded task assignment, identifying avoidant behaviors, and rating one's sense of accomplishment.
16212070|NCT01299766|Behavioral|Supportive Therapy (ST)|ST is a person-centered psychotherapy in which interventionists create a comfortable, non-judgmental environment by demonstrating genuineness, empathy, and acceptance of subjects without imposing any judgments on their decisions.
16212071|NCT01299753|Drug|placebo|identically packed placebo
16212072|NCT01299753|Drug|propranolol|20-40 mg q6-8h
16212383|NCT01297153|Device|No IOL|No IOL will be implanted in these eyes
16212073|NCT01299740|Behavioral|Participation in DBT Skills Group|Participation of 20 group meetings lasting an hour and a half for the children, and 15 group meetings lasting an hour and a half for the parents.
16212074|NCT01299740|Other|Control Group|Treatment as usual
16212075|NCT01299727|Biological|rhHNS-10 mg|Once per month via an Intrathecal Drug Delivery Device (IDDD) for a maximum of 8 years
16212076|NCT01299727|Biological|rhHNS-45 mg|Once per month via an Intrathecal Drug Delivery Device (IDDD) for a maximum of 8 years
16212077|NCT01299727|Biological|rhHNS-90 mg|Once per month via an Intrathecal Drug Delivery Device (IDDD) for a maximum of 8 years
16212078|NCT01299701|Drug|ASA404|(5,6-dimethylxanthenone-4-acetic acid) DMXAA or DXAA
16212079|NCT01299662|Drug|Poly ICLC|One 1.6 mg subcutaneous injection of the study drug, poly ICLC in the upper arm.
16212080|NCT01299636|Drug|PM060184|PM060184 administered intravenously (i.v.) over 10 minutes at a starting dose of 4 mg/m2/day on three consecutive days q2w (on Days 1-3 and 15-17) every 28 days.
16212081|NCT01299623|Behavioral|Comparison of evidential versus non-evidential education on women's breast cancer prevention behaviors|Participants will be randomized to either the evidential or non-evidential group. Both groups will receive primarily the same information, except one group will receive information that is more tailored to African American women, while participants in the other group will receive general information about breast cancer prevention.
16212082|NCT01299610|Drug|GW870086 2.0%|White to slightly colored opaque cream
16212083|NCT01299610|Drug|GW870086 0.2%|White to slightly colored opaque cream
16212084|NCT01299610|Drug|FP 0.05%|White cream
16212085|NCT01299610|Drug|Placebo|White to slightly colored opaque cream
16212086|NCT01299597|Drug|Atorvastatin|20mg single dose given alone and coadministered with SB649868 on day 8 and 12 of the 14-day repeat dose period.
16212087|NCT01299597|Drug|Simvastatin|10mg single dose given alone and coadministered with SB649868 on day 12 and 14 of the 14-day repeat dose period.
16212088|NCT01299597|Drug|SB649868|20mg daily given for 14 days.
16212089|NCT01299584|Drug|Remifentanil|Basically there is no treatment allocation. Subjects who would be administered of remifentanil at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.
16212090|NCT01299571|Drug|Dutasteride|Basically there is no treatment allocation. Subjects who would be administered of dutasteride at their physicians' discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.
16212091|NCT01299558|Drug|fluticasone furoate//GW642444|Single inhaled dose of FF (800mcg)/GW642444M (100mcg) Inhalation Powder administered in the morning
16212092|NCT01299558|Drug|fluticasone furoate|Single IV dose of FF (250mcg)
16212093|NCT01299558|Drug|GW642444|Single IV dose of GW642444 (55mcg)
16212094|NCT01299532|Device|Macrolane VRF30|Device: Macrolane VRF30 (stabilized hyaluronic acid of non-animal origin) Treatment: Initial injection of a maximum of 120 ml/breast. Re-injection of a maximum of 120 ml/breast in a subgroup of subjects.
16212095|NCT01299519|Behavioral|Weight Maintenance|Subjects in the weight maintenance arm will maintain a steady body weight (plus or minus 2% of initial body weight) for six months.
16212096|NCT01299519|Behavioral|Weight Loss|Half of the subjects in the weight loss arm will lose 5% of their weight through a low-calorie diet, and half will also lose 10% and 15% body weight.
16212097|NCT01299493|Other|Systems-level intervention to promote colon cancer screening|Intervention practices will receive access to, and assistance in implementing, evidence-based strategies for increasing colorectal cancer screening rates.
16212098|NCT01299480|Biological|Vaccine|rLP2086 vaccine at visits 1, 2 and 5, saline at visit 3
16212099|NCT01299480|Biological|Vaccine|rLP2086 vaccine at visits 1, 3, and 5, saline at visit 2
16212100|NCT01299480|Biological|Vaccine|rLP2086 vaccine at visits 1, and 5, saline at visits 2 and 3
16212101|NCT01299480|Biological|Vaccine|rLP2086 at visits 1 and 3, saline at visits 2 and 5
16212102|NCT01299480|Biological|Vaccine|rLP2086 at visits 3 and 5, saline at visits 1 and 2
16212103|NCT01299467|Drug|Active (PF-03526299)|Capsules for inhalation, 1.396 mg twice a day for up to 13 days. Last dose given 0.5 hrs before allergen challenge
16212104|NCT01299467|Drug|Active (PF-03526299)|Capsules for inhalation, 1.396 mg twice a day for up to 12 days. Last dose given 8 hrs before allergen challenge
16212105|NCT01299467|Drug|Placebo|Capsules for inhalation, Placebo, twice a day for up to 13 days. Last dose given 0.5 hrs before allergen challenge
16212106|NCT01299467|Drug|Active (PF-03526299)|Capsules for inhalation, 4.188 mg twice a day for up to 13 days. Last dose given 0.5 hrs before allergen challenge
16212107|NCT01299467|Drug|Active (PF-03526299)|Capsules for inhalation, 4.188 mg twice a day for up to 12 days. Last dose given 8hrs before allergen challenge
16212108|NCT01299467|Drug|Placebo|Capsules for inhalation, Placebo, twice a day for up to 13 days. Last dose given 0.5 hrs before allergen challenge
16212109|NCT01299454|Drug|OPC-34712|All groups will receive a single oral 2-mg OPC-34712 dose on Day 1 with 240 mL room temperature still water. Subjects will be administered the OPC-34712 dose in the fasted state (at least 8 hours of fasting) and no food will be allowed for 4 hours postdose. Water will be restricted as part of the dosing procedure from 1 hour prior to dosing and 2 hours post-dose.
16212110|NCT01299441|Device|ECOM ETT|Intubation with ECOM endotracheal tube (ETT)
16212111|NCT01299428|Device|INVOS 5100|INVOS 5100 IS AN EQUIPMENT THAT MEASURED CEREBRAL OXYGENATION WITH NEAR INFRARED SPECTROPHOTOMETRY METHOD.
16212112|NCT01299415|Drug|Vadimezan™|
16212113|NCT01299402|Dietary Supplement|Soulera Herbal Blend|This a powder blend of various reputed adaptogenic herbs. The dosage will be one 8.6 gram powder sachet daily.
16212114|NCT01299402|Dietary Supplement|Placebo|The placebo will be a similar tasting and looking powder blend as the Soulera Herbal Blend. The dosage will be 8.6 grams per sachet daily.
16212115|NCT01299389|Drug|Paliperidone palmitate|Paliperidone palmitate will be given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64. Participants who complete double-blind period or discontinued early from double-blind period will have follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants will not receive any study drug during post-observational period.
16212116|NCT01299389|Drug|Placebo|Matching Placebo will be given intramuscularly (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64. Participants who complete double-blind period or discontinued early from double-blind period will have follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants will not receive any study drug during post-observational period.
16212117|NCT01299376|Drug|L50/H12.5/A5|
16212118|NCT01299376|Drug|L50/H12.5|
16212119|NCT01299376|Drug|Placebo to L50/H12.5/A5|
16212120|NCT01299376|Drug|Placebo to L50/H12.5|
16212121|NCT01299363|Behavioral|Dilator use|Women randomized to vaginal dilators will be given instructions to perform exercises with vaginal dilators from postoperative weeks 4 to 8
16212122|NCT01299350|Other|Nt-proBNP guided discharge|Every patient will receive the drug treatment indicated in the guidelines of the European Society of Cardiology. Patients will be discharged the third day if NT-proBNP levels drops >30% compared to admission values. If such a reduction is not achieved, then the pharmacological treatment will be increased and NT-proBNP will be measured the following days until reaching the 30% reduction. The cutoff point of 30% reduction in NTproBNP was chosen based on previous studies
16212123|NCT01299337|Drug|T3|Given each day of ECT treatment 25 mg for the first 5 days increasing to 50 mg for the duration of treatment.
16212124|NCT01299324|Device|BMAC infusion|Infusion of 60 mL of Bone Marrow Aspirate Concentrate
16212125|NCT01299311|Behavioral|NEAT|4 days of everyday activities, including 4 hours of walking, 8 hours of sitting, 2 hours of standing, 2 hours of everyday activities and 8 hours of sleeping or laying down per day
16212126|NCT01299311|Behavioral|Exercise|4 days of activity program, including 1 hour biking (exercise), 13 hours of sitting, 2 hours of everyday activities and 8 hours of sleeping or laying down per day
16212127|NCT01299298|Drug|mipomersen|50 mg (cohort A), 100mg (cohort B) or 200mg (cohort C) subcutaneous (SC) single dose of study drug
16212128|NCT01299298|Drug|placebo|50 mg (cohort A), 100mg (cohort B), or 200mg (cohort C) subcutaneous (SC) single dose of study drug
16212129|NCT01299285|Drug|LY3009104|Administered orally
16212130|NCT01299272|Drug|LY2216684|
16212131|NCT01299272|Drug|Placebo|
16212132|NCT01299272|Drug|SSRI|Participants should have been on their SSRI for at least 8 weeks prior and were to continue on their stable dose throughout the study.
16212133|NCT01299259|Behavioral|Text Message Reminders|Patients in the intervention group will receive text messages on their cell phones following discharge from the emergency department reminding them to make an appointment with their primary care provider. Text messages will be sent daily for 4 days after discharge from the ED.
16212134|NCT01299246|Procedure|Michigan Neuropathy Screening Instrument|Peripheral neurological assessment was carried out using MNSI. The diabetes nurse educators assessed five parameters on both feet and counted the total points, ranging from 0 to10: (1) Appearance of feet; if abnormal, then inspection of lower limbs for deformities was carried out; (2) Identification of foot ulceration; (3) Vibration perception of the big toe; (4) Ankle reflexes; (5) touch-pressure sensation test with a 10 g Semmes-Weinstein monofilament.
16212135|NCT01299233|Device|Spectralis® SD-OCT, Heidelberg Engineering GmbH, H|Measurement of the peripapillar nerve fiber layer with different settings of ART
16212136|NCT01299220|Drug|Acitretin|Acitretin 10 mg by mouth daily
16212137|NCT01299194|Drug|ATORVASTATIN|80mg once daily for 3 months
16212138|NCT01299181|Drug|Atorvastatin|80mg once daily orally
16212139|NCT01299155|Device|ReSTOR +3|Bilateral implantation of an Alcon AcrySof ReSTOR +3 Intraocular Lens (IOL) Model SN6AD1 following cataract extraction.
16212140|NCT01299155|Device|LENTIS MPlus|Bilateral implantation of a LENTIS MPlus Intraocular Lens (IOL) following cataract extraction.
16212141|NCT01299142|Drug|FGI-101-1A6|anti-TSG101 human monoclonal antibody, single dose
16212142|NCT01299116|Drug|DMPA|Injectable contraceptive, containing 150 mg depot medroxyprogesterone acetate (DMPA) and marketed in the US as Depo-Provera® or containing 104 mg DMPA and marketed as Depo-SubQ Provera 104®.
16212143|NCT01299116|Drug|oral contraceptives|Oral contraceptives (any variety of formulations are permitted)
16212144|NCT01299116|Drug|Implanon®|Subdermal contraceptive implant, marketed in the US as Implanon® or Nexplanon® (containing 68 mg of etonogestrel)
16212145|NCT01299116|Drug|ParaGard®|Intrauterine device marketed in the US as ParaGard® (a T-shaped plastic device containing 380mm2 of copper surface)
16212146|NCT01299116|Drug|Mirena®|Intrauterine system, marketed in the US as Mirena® (containing 52 mg of levonorgestrel)
16212147|NCT01299103|Device|Pelleve Wrinkle Treatment System|comparison of single vs. double and triple treatment with the Pelleve Wrinkle Treatment System
16212148|NCT01299090|Device|Pelleve Wrinkle Treatment System - includes the Pelleve Handpiece and S5 generator|two treatments spaced 30 days apart
16212149|NCT01299051|Behavioral|Steps to Health|"Steps to Health (STH): The STH curriculum is a 12-month educational program targeting obese employees for healthy lifestyle changes for weight loss. The program includes:
~Face-to-face visit with counselor during Month 1 to set specific health goals.
~Telephone counseling at 6 and 12 months, coupled with biometric feedback sessions.
~Monthly generic health education materials sent via e-mail.
~Incentives (up to 1,000 STH dollars [$100]) to take part in the program assessments."
16212150|NCT01299051|Behavioral|Steps to Health Plus!|"The STH+ intervention is an intensive 12-month behavioral intervention targeting obese employees. It is stage-based and works with the participant at his/her level of readiness to change using counseling based on motivational interviewing. STH+ includes:
~Face-to-face visit with counselor at Month 1
~Meeting with exercise physiologist in Month 2
~Monthly counseling sessions (in-person in Months 3, 6, 9 and 12, others via telephone)
~Meeting with exercise physiologist during Month 5
~Quarterly biometric feedback (Months 3, 6, 9, and 12)
~Incentives (up to 1,000 STH dollars [$100]) to take part in the program assessments."
16212151|NCT01299038|Drug|rosuvastatin|Taken orally once a day for 4 weeks
16212152|NCT01299025|Other|Training using Nintendo Wii Fit|Training 2 times per week, 30 minutes, for 6 weeks.
16212153|NCT01299012|Drug|Liraglutide|Liraglutide s/c 0.6mg once daily.
16212154|NCT01298999|Drug|YF476|25 mg: one capsule to be taken by mouth once daily for 12 weeks.
16212155|NCT01298999|Drug|Placebo|Matching placebo: one capsule to be taken by mouth once daily for 12 weeks.
16212858|NCT01293136|Drug|Intravenous opioids|Whatever opioids prescribed
16212156|NCT01298986|Procedure|Pulmonary vein isolation ablation procedure for atrial fibrillation|The catheters will be introduced to the right atrium using the femoral vein as an access. Following a trans-septal puncture, ablation catheters will be placed in the left atrium under appropriate imaging and anticoagulation conditions (Standard of care). Following the positioning of the ablation catheters in the left heart cavity ablation to achieve PVI and left atrial isthmus line are going to be performed. Following the appropriate protocol of mapping and AF induction the right sided isthmus is going to be ablated to achieve a flutter line ablation as well. Following the procedure and following the appropriate standard of care protocols, the catheter are going to be retrieved and the procedure will be concluded. The left atrial appendage will be managed surgically. All ablation lines will be placed according to their current standard of practice using radiofrequency ablation technology and based on CARTO mapping.
16212157|NCT01298986|Procedure|Hybrid procedure for ablation of atrial fibrillation|The endoscope will be passed though a small port in the right thoracic cavity to the beating heart. The pericardium will be opened, the coronary sinus transected. The ablation catheters will pass underneath the SVC and IVC establishing access to the transverse and oblique sinuses. A box lesion will be epicardially placed around the pulmonary veins using cryothermia. An additional lesion line will be placed from the box lesion to the left atrial appendage. The ablation catheter will be left in place to guide the EP physicians in placing the right and left atrial flutter lines using radiofrequency. Electromagnetic mapping using a CARTO system and measuring for conduction block of the pulmonary veins will be conducted by the EP's. A second small port will then placed in the left thoracic cavity and the pericardium on the left side will be opened and the left atrial appendage will be ablated with the use of a clip placed around the left atrial appendage and tightened.
16212158|NCT01298986|Procedure|The Cox Maze Procedure for Ablation of Atrial Fibrillation|A 7-cm incision is placed and the chest is entered through the 4th or 5th intercostal space. The femoral artery and femoral vein are cannulated. The pericardium is opened. Cardiopulmonary bypass is instituted. The right sided lesions are applied using 3 purse-strings that are placed over the right atrial free wall. The right and left atrial lesions are done using cryoablation using either nitrous oxide or Argon. Next the left atrium is entered through a standard atriotomy placed in the interatrial groove. The base of the left atrial appendage is cryoablated and connected to the left upper pulmonary vein. All four pulmonary veins are then encircled using multiple application of cryo. An endocardial cryolesion is then placed posteriorly down to the level of the mid-mitral valve annulus and an epicardial cryolesion is placed on the coronary sinus directly across the atrial wall from the endocardial lesion. The left atrial appendage is then surgically managed.
16212159|NCT01298986|Procedure|Hybrid Procedure for Left Atrium >5 cm but < 6.1 cm|The endoscope will be passed though a small port in the right thoracic cavity to the beating heart. The pericardium will be opened, the coronary sinus transected. The ablation catheters will pass underneath the SVC and IVC establishing access to the transverse and oblique sinuses. A box lesion will be epicardially placed around the pulmonary veins using cryothermia. An additional lesion line will be placed from the box lesion to the left atrial appendage. The ablation catheter will be left in place to guide the EP physicians in placing the right and left atrial flutter lines using radiofrequency. Electromagnetic mapping using a CARTO system and measuring for conduction block of the pulmonary veins will be conducted by the EP's. A second small port will then placed in the left thoracic cavity and the pericardium on the left side will be opened and the left atrial appendage will be ablated with the use of a clip placed around the left atrial appendage and tightened.
16212160|NCT01298973|Drug|Viscoat|One group will receive Viscoat for incision closure
16212161|NCT01298973|Drug|Saline|One group will receive Saline to irrigate the wound
16212162|NCT01298960|Drug|Somatropin|0.1 IU/Kg/day from day one of stimulation until rHCG triggering
16212163|NCT01298947|Device|Laser Atherectomy (Spectranetics CE marked peripheral laser atherectomy catheters (including Turbo Elite®), Turbo-Booster® and Turbo Tandem™ Systems|comparing the use of a Paclitaxel-eluting angioplasty balloon (PTX PTA) with initial photoablation to the use of PTX PTA alone in the treatment of instent lesions in femoropopliteal arteries
16212164|NCT01298934|Drug|LBH589|Dose escalation study starting at 20mg by mouth three times a week, given weekly for 24 weeks in the phase I portion of the study.
16212165|NCT01298921|Drug|Oxygen|A demand valve delivers oxygen to the user as soon as they try to inhale from an attached mask or mouth tube. As the user starts to inhale, the slight drop in pressure within the mouth piece or mask lifts a valve and starts the oxygen flow. If the user inhales more deeply, more oxygen will flow in response to the increased demand, hence the name demand valve. Unlike a constant flow O2 regulator, a demand valve has no flow meter or flow rate controls, but it is capable of delivering O2 from 0 to 160 liters per minute (LPM). When using a demand valve, O2 dosage is controlled by respiration rate
16212166|NCT01298921|Drug|Oxygen|100 percent continuous oxygen given via a non-rebreather facemask at 7 to 15 liters per minute for 20 minutes
16212167|NCT01298908|Procedure|Operative treatment|In operative treatment the great saphenous vein will be removed after flush ligation by femoral vein and stripping of the trunk.
16212168|NCT01298908|Procedure|Laser ablation|In intravenous laser treatment a thin laser fiber is inserted through a tiny distal entry point. The probe is guided into place using ultrasound and the procedure is performed under local tumescence anesthesia. Laser energy is delivered to seal the faulty vein.
16212169|NCT01298908|Procedure|Foam sclerotherapy|Ultrasound guided foam sclerotherapy involves an injection of foam (sodium tetradecyl sulfate mixed with air according to the Thessari method) directly into the venous trunk under ultrasound control.
16212170|NCT01298882|Drug|Diacerein|
16212171|NCT01298882|Other|Placebo|
16212172|NCT01298869|Biological|HPV-6/11/16/18 vaccine|HPV-6/11/16/18 vaccination 3 doses at day 1, month 2, and month 6
16212173|NCT01298856|Procedure|hydrotherapy|hydrotherapy and ankle taping and land-based
16212174|NCT01298843|Drug|Ceftaroline fosamil|Single dose of 15 mg/kg (up to 600 mg) by intravenous infusion
16212175|NCT01298830|Drug|GLP-1 CellBeads|GLP-1 CellBeads are alginate microcapsules containing allogenic mesenchymal cells, transfected to secrete Glucagon like peptide-1. By implantation into brain tissue cavity after surgical evacuation of the hematoma, a volume of 500μl GLP-1 CellBeads which equals approximately 2330 GLP-1 CellBeads resulting in a total number of approximately 7.8 million cells is administered to the patient. The cells are removed by second surgery after a 14 days treatment period.
16212859|NCT01293123|Drug|Raltegravir|raltegravir 400 mg PO twice daily
16212176|NCT01298817|Dietary Supplement|Medifast meal replacement products|A total of 4 meal replacement (MR)products per participant per day will be used. Approximately 2/3rd of the Medifast® MR product line is soy protein-based (i.e. at least 7 g of total protein coming from soy) with the remaining 1/3rd of items deriving total protein content from animal sources (whey and egg). The soy used in Medifast products is Solae SUPRO® water-washed soy protein isolate. Depending on seasonal variations, soy MR products contain approximately 1.5-3.0 milligrams of soy isoflavones for every 1 gram of soy protein. Thus, participants in the soy treatment arm will consume at least 28 g/soy protein and 42-108 mg/isoflavones per day.
16212177|NCT01298817|Dietary Supplement|Medifast meal replacement products|A total of 4 meal replacement (MR)products per participant per day will be used. Approximately 2/3rd of the Medifast® MR product line is soy protein-based (i.e. at least 7 g of total protein coming from soy) with the remaining 1/3rd of items deriving total protein content from animal sources (whey and egg). This group will receive the non soy supplements.
16212178|NCT01298804|Behavioral|Problem Solving Education and Activated Referral to Care|"The intervention represents an integrated identification and intervention system based on the evidence-based construct of screening, brief intervention, and referral to treatment (SBIRT). Within the comprehensive case management services of Head Start, eligible women will be randomized to receive either usual care or the Head Start-based intervention. In our intervention, mothers at risk for depression will receive a problem-solving intervention; depression symptom monitoring; and an Activated referral to more definitive services for those who have worsening symptoms over time."
16212179|NCT01298791|Behavioral|Sitting|Providers will sit during inpatient family-centered walk rounds throughout the communication during rounds. The participating members of the care team (attending physician, resident and medical student) will remain seated while communicating with the patient and caregiver.
16212180|NCT01298791|Behavioral|Standing|Providers will stand during inpatient family-centered walk rounds throughout the communication during rounds. The participating members of the care team (attending physician, resident and medical student) will remain standing while communicating with the patient and caregiver.
16212181|NCT01298778|Drug|Duramorph 150|Duramorph 150 mcg x 1 dose spinally + placebo capsules 2 PO q 6 hrs first 24 hrs postop x 4 doses
16212182|NCT01298778|Drug|Acetaminophen|Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses
16212183|NCT01298778|Drug|Duramorph 300|Duramorph 300 mcg spinally + acetaminophen 1 GM q 6 hrs first 24 hrs postop x 4 doses
16212184|NCT01298765|Drug|BEMA Buprenorphine|buccal soluble film; applied to the buccal mucosa twice daily
16212185|NCT01298752|Drug|Mapracorat|Mapracorat ophthalmic suspension 3%, one drop in post-operative study eye once daily (QD) for 2 weeks.
16212186|NCT01298752|Drug|Vehicle|Vehicle of mapracorat ophthalmic suspension, one drop in post-operative study eye once daily (QD) for 2 weeks.
16212187|NCT01298726|Other|PHARMACEUTICAL CARE|The pharmaceutical care program was characterized by face to face monthly visits to collect information, register information, prepare plan of care for every health problem; identification of drug therapy problems, communication to prescribers the drug therapy problems identified and education of participants to resolve the drug therapy problems.
16212188|NCT01298726|Other|HEALTH USUAL CARE|Usual care as defined in health consultations with doctors, nutritionists and nurses, access to laboratory tests and essential medicines
16212189|NCT01298713|Drug|Tamoxifen|20mg daily (1 cap) until unbearable toxicity or progression
16212190|NCT01298713|Drug|Everolimus|10mg daily (2 caps of 5mg) until unbearable toxicity or progression
16212191|NCT01298700|Drug|bimatoprost 0.01% ophthalmic solution|One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
16212192|NCT01298700|Drug|bimatoprost 0.03% ophthalmic solution|One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
16212193|NCT01298687|Drug|Travoprost Ophthalmic Solution, 0.00013%|Cumulative daily dose is below the travoprost ophthalmic solution, 0.004% once daily dose
16212194|NCT01298687|Drug|Travoprost Ophthalmic Solution, 0.00033%|Cumulative daily dose equals the travoprost ophthalmic solution, 0.004% once daily dose
16212195|NCT01298687|Drug|Travoprost Ophthalmic Solution, 0.001%|Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose
16212196|NCT01298687|Drug|Travoprost Ophthalmic Solution, 0.00267%|Cumulative daily dose is above the travoprost ophthalmic solution, 0.004% once daily dose
16212197|NCT01298687|Drug|Travoprost Ophthalmic Solution, 0.004%|
16212198|NCT01298687|Drug|Travoprost Vehicle|Inactive ingredients used as an active comparator
16212199|NCT01298661|Other|Six-minute Step Test|The patients underwent a test where they need to step up and down a 20cm test during six minutes.
16212200|NCT01298635|Procedure|combined phacotrabeculectomy|trabeculectomy plus phacoemulsification with intraocular lens implantation
16212201|NCT01298635|Procedure|trabeculectomy|
16212202|NCT01298609|Device|Occipital Stimulation|Occipital Nerve Stimulation will be used in each study arm using the Eon Mini neuromodulation system
16212203|NCT01298596|Procedure|Loop Electrosurgical Excision Procedure (LEEP)|LEEP procedure uses a low-voltage electrified wire loop to cut out diseased part of cervix
16212204|NCT01298596|Procedure|Cryotherapy|Cryotherapy procedure involves using a cryoprobe and carbon dioxide or nitrous oxide gas to freeze the diseased part of the cervix
16212205|NCT01298583|Behavioral|ankle tracking training|one group will use the ankle for tracking, the other group will use the ankle for simple movement
16212206|NCT01298570|Drug|Regorafenib (BAY 73-4506)|Regorafenib, 160 mg, PO, Days 4-10 and Days 18-24 of 28 day cycle
16212207|NCT01298570|Drug|FOLFIRI|FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle.
16212208|NCT01298570|Drug|Placebo|Placebo, 160 mg, PO, Days 4-10 and Days 18-24 of 28 day cycle
16212209|NCT01298570|Drug|FOLFIRI|FOLFIRI (Irinotecan,180 mg/m2 IV over 90 minutes; 5-Fluorouracil l400 mg/m2 IV bolus followed by 2400 mg/m2 IV over 46 hours; Leucovorin 200-400c mg/m2 IV over 2 hours) Day 1 and Day 15 of each 28 day cycle.
16212210|NCT01298544|Procedure|Blood draw|One 5mL blood draw for immunogenicity at least 3 years post completion of clinical study 0887X-101518.
16212211|NCT01298531|Drug|etanercept|etanercept 50 mg subcutaneous (SC) injections once weekly for 16 weeks.
16212212|NCT01298531|Drug|etanercept|etanercept 50 mg subcutaneous (SC) injections once weekly for 8 weeks following the prior 8 weeks of placebo.
16212213|NCT01298531|Drug|placebo|placebo subcutaneous (SC) injections once weekly for 8 weeks.
16212214|NCT01298518|Drug|PF-04620110|5 mg of PF-04620110 given once daily
16212215|NCT01298518|Drug|PF-04620110|2.5 mg of PF-04620110 given twice daily
16212216|NCT01298518|Drug|Placebo|Matching placebo giving for 4 weeks
16212217|NCT01298505|Drug|PF-03654764 2.5mg plus fexofenadine 60mg|PF-03654764 2.5mg plus fexofenadine 60mg twice daily for 7 days
16212218|NCT01298505|Drug|PF-03654764 5mg plus fexofenadine 60mg|PF-03654764 5mg plus fexofenadine 60mg twice daily for 7 days
16212219|NCT01298505|Drug|placebo|placebo given twice daily for 7 days
16212220|NCT01298492|Drug|PF-00547659|75 mg SC once monthly for 72 weeks. Subjects may escalate to 225 mg or de-escalate to 22.5 mg one time.
16212221|NCT01298479|Other|Uniject|single use container
16212222|NCT01298466|Drug|Pregabalin|The investigator will administer pregabalin in a flexible dose-escalation regimen as follows: 150 mg per night for 1 week, 300 mg per day for 1 week, 450 mg per day for 1 week, then 600 mg per day through to the end of the study. Patients may change the dose of medication based on individual response and tolerability as determined by the investigator.
16212223|NCT01298414|Genetic|RNA analysis|
16212224|NCT01298414|Other|laboratory biomarker analysis|
16212225|NCT01298401|Biological|ganitumab|
16212226|NCT01298401|Drug|capecitabine|
16212227|NCT01298401|Drug|gemcitabine hydrochloride|
16212228|NCT01298401|Radiation|3-dimensional conformal radiation therapy|
16212229|NCT01298388|Other|medical chart review|
16212230|NCT01298388|Other|questionnaire administration|
16212231|NCT01298388|Other|study of socioeconomic and demographic variables|
16212232|NCT01298362|Drug|Aromatase Inhibitors|
16212233|NCT01298362|Drug|Chemotherapy|
16212234|NCT01298336|Drug|Clarithromycin|500 mg twice a day seven days a week
16212235|NCT01298336|Drug|Moxifloxacin|400 mg per day seven days a week
16212236|NCT01298323|Behavioral|Patient outreach|Patients will be contacted at week 1 and then every 2 weeks until completion of 52 weeks to detect/treat AEs sooner
16212237|NCT01298323|Drug|Vandetanib|Treatment 300mg vandetanib opel label.
16212238|NCT01298310|Drug|Xylocaine|1 mg/mL solution for injection
16212239|NCT01298310|Drug|Xylocaine|10 mg/mL solution for injection
16212240|NCT01298310|Drug|Placebo|solution for injection
16212241|NCT01298297|Drug|Buprenorphine|0.4 mg, SL (sublingual) Buprenorphine PLUS 5 ml Placebo IV (in the vein)
16212242|NCT01298297|Drug|Morphine|Placebo SL PLUS 5 ml Morphine sulfate (1mg/ml) IV
16212243|NCT01298284|Drug|propranolol|Starting from 20 mg daily, titrated weekly to decrease heart rate more than 25 % of baseline, administrated during the whole study period
16212244|NCT01298271|Drug|propranolol|Starting from 20 mg daily, titrated weekly to decrease heart rate more than 25 % of baseline, administrated during the whole study period
16212245|NCT01298258|Drug|Aliskiren|Aliskiren 150mg
16212246|NCT01298232|Other|Cardiophonogram|Using data from cardiophonogram, the EMAT and S3 intensity, to guided clinical therapy for acute heart failure
16212247|NCT01298219|Drug|Lubiprostone|24 mcg administered orally twice daily (BID)
16212248|NCT01298219|Drug|Placebo|Matching placebo, 0 mcg administered orally twice daily (BID)
16212249|NCT01298193|Drug|Aprepitant|Efficacy phase (second cycle)
16212250|NCT01298180|Drug|Growth hormone (Genotonorm® or Omnitrope®)|drug : the treatment will be begun in progressive dose by beginning by ¼ of the dose the first week, then ½ of the dose the second week, then 3/4 of the dose the third week and total dose the fourth week.
16212251|NCT01298180|Procedure|DEXA, blood tests, H.G.P.O, osseous age.|"SPW, GHD, SPW-B :
~blood tests : centralized dosage H.G.P.O : adjusted to children's age."
16212252|NCT01298180|Procedure|biopsy|Biopsy : Cutaneous and fat tissue biopsy.
16212253|NCT01298167|Device|Cyanoacrylate tissue glue versus Fast absorbing gut|All wounds will be closed using a linear, bilayered closure method, where the buried intradermal absorbing suture (5-0, Polysorb) will be placed along the length of the incision, consistent with standard surgical procedure. Only patients with wounds with a length of 3cm or greater will be enrolled. Each wound will be measured, and the length divided in half. Half of the surgical wound will be randomly selected (by coin toss) for epidermal reapproximation with cyanoacrylate, whereas the other half will be repaired with 6-0 fast absorbing gut suture in standard running fashion.
16212254|NCT01298154|Other|Dietary intervention|Dietary treatments with beverages
16212255|NCT01298141|Biological|agalsidase alfa|"Cohort 1: 0.2 mg/kg body weight administered as an intravenous (IV) infusion over 40 minutes every other week (EOW)
~Cohort 2: 0.2 mg/kg body weight administered as an intravenous (IV) infusion over 40 minutes weekly"
16212256|NCT01298128|Drug|NuvaRing|NuvaRIng 21 days for IVF pre-treatment.
16212257|NCT01298128|Drug|marvelon|marvelon 21 daily
16212258|NCT01298102|Biological|Influenza A/H1N1 2009-AS03 adjuvanted (Pandemrix)|intramuscular injection of 1 dose vaccine
16212259|NCT01298089|Device|Carriazo Pendular microkeratome|
16212260|NCT01298076|Drug|bevacizumab|Anti-VEGF drug for intravitreal injection
16212261|NCT01298076|Drug|dexamethasone|Slow-release steroid formulation for intravitreal injection
16212262|NCT01298063|Drug|Afatinib|1 tablet, once qd in the morning
16212263|NCT01298063|Drug|Afatinib|1 tablet, once qd in the morning
16212264|NCT01298063|Drug|Afatinib|1 tablet, once qd in the morning
16212265|NCT01298050|Procedure|ECMO|Insertion of peripheral Veno-Arterious ECMO, subsequent therapeutic hypothermia
16212266|NCT01298024|Other|Early Neuromuscular Exercise|30 patients are randomized to early neuromuscular exercise (n=15) or treatment as usual, i.e., late exercise (n=15). Both groups are given an orthosis and are instructed to wear this for eight weeks. The experimental group starts with a structured exercise program one week after the diagnosis. The patients attend one training session/week during eight weeks, guided by a physical therapist. The level of training is progressed during this time. The patients in the control group (treatment as usual) are given exercise instructions and information at one occasion; 2 weeks after diagnosis. Both groups are followed up, by a blinded assessor, with valid and reliable self-reported and physical function outcomes at 1, 4, 8 and 16 weeks after injury.
16212267|NCT01298011|Drug|Gemcitabine and Abraxane|3 treatments for gemcitabine and abraxane every 28-days for 3 months, prior to surgery.
16212268|NCT01297998|Drug|gemcitabine , cisplatin|Dose of gemcitabine and cisplatin and treatment schedule
16212269|NCT01297985|Behavioral|BRIDGES Peer-Led Education|The BRIDGES program is a 10-week, manualized education course designed to provide basic education about the etiology and treatment of mental illness, self-help skills, and recovery principles in order to empower participants to return to valued social roles within their communities. BRIDGES is a peer-led program and all instructors are adults with mental illnesses. For this intervention study, the BRIDGES curriculum was modified from a week course to an 8-week course, meeting for 2 1/2 hours once a week.
16212270|NCT01297972|Biological|Intravenous bone marrow mesenchymal stem cells infusion|After standard immunosuppressive therapy with rabbit antithymocyte globulin 3,5 mg/Kg/day during 5 days, allogeneic unrelated bone marrow derived mesenchymal stem cells will be infused intravenously. Oral cyclosporine 5 mg/Kg/day (with dose correction weekly to keep serum cyclosporine level between 150-250 mg/dl) up to 6 months will be added.
16212271|NCT01297959|Drug|E-101 Solution 300 GU/ml|8 mL of E-101 Solution
16212272|NCT01297959|Drug|Saline solution|Saline solution matched to E-101
16212273|NCT01297946|Device|Conventional continuous subcutaneous insulin infusion therapy|
16212274|NCT01297946|Device|Dual-hormone closed-loop|
16212275|NCT01297933|Drug|Omegaven|10% Omegaven 1g/kg/day, Intravenous by continuous infusion in conjunction with parenteral nutrition, until the patient no longer requires parenteral nutrition or until participation in the study is terminated.
16212276|NCT01297920|Drug|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension|
16212277|NCT01297920|Drug|Brinzolamide ophthalmic suspension, 1%|
16212278|NCT01297920|Drug|Brimonidine tartrate ophthalmic solution, 0.2%|
16212279|NCT01297907|Other|Methacholine Challenge Test|Methacholine challenge test to evaluate airway hyperreactivity
16212280|NCT01297907|Other|Fractional Exhaled NO (FENO)|Fractional Exhaled NO to evaluate eosinophilic inflammation
16212281|NCT01297907|Other|Blood Test|Blood Tests (Eosinophil Count)
16212282|NCT01297907|Other|PCDAI|Clinical Evaluation for Pediatric Crohn's Disease Activity Index (PCDAI)
16212283|NCT01297894|Drug|colistin|Colistimethate sodium 2.5-5mg/kg of colistin base
16212284|NCT01297894|Drug|colistin plus fosfomycin|colitimethate sodium 2.5-5mg/kg iv plus fosfomycin 2gm iv every 12 hours
16212285|NCT01297868|Other|exercise|
16212286|NCT01297855|Drug|Colistin|Colistimethate Sodium dose 2.5-5mg/kg/day
16212287|NCT01297855|Drug|Colistin plus Rifampicin|Colistin 2.5 to 5 mg/ Kg/ day Rifampin 10 mg/ Kg/ day
16212288|NCT01297842|Drug|Ertapenem|Ertapenem 1 gram per day for 7 to 14 days
16212289|NCT01297842|Drug|Meropenem or Imipenem|Meropenem or Imipenem 0.5 to 1 gram 3 to 4 times per day for 7 to 14 days
16212290|NCT01297829|Drug|Intravenous Ibuprofen|800 mg IV ibuprofen 30 minutes preoperatively
16212291|NCT01297829|Other|IV Placebo|IV normal saline
16212292|NCT01297816|Drug|placebo|100mg,BD, fo three month
16212293|NCT01297816|Drug|Minocycline|100mg
16212294|NCT01297803|Drug|Mitomycin_c|0.02%.1,2,3,minutes match randomized in to two groups(before &after scleral flap dissection
16212295|NCT01297803|Drug|Mitomycin_c|0.02%.1,2,3,minutes match randomized in to two groups(before &after scleral flap dissection
16212296|NCT01297790|Other|Cough Challenge Tests|Inhalational cough challenge tests with capsaicin, bradykinin, Citric acid and prostaglandin E2
16212297|NCT01297790|Other|ambulatory cough recording|Cough recording with a portable device to capture cough sounds
16212298|NCT01297790|Other|Cough questionnaires|Questionnaires designed to study cough. These include Leicester cough questionnaire, cough visual analogue score and cough quality of life questionnaire.
16212299|NCT01297777|Drug|Imatinib Mesylate|"In patients without B or C findings and without biological progression: 300 mg/24 h p.o during one year or until progression/unacceptable toxicity.
~In patients with B or C findings or biological progression: 300 mg/24 h p.o for two weeks and then 400 mg/24 h p.o for a total of one year of therapy, or until progression/unacceptable toxicity."
16212300|NCT01297764|Drug|Vorinostat, Lenalidomide, Carfilzomib, Dexamethasone|"Dose Escalation Schema Cohort Carfilzomib (mg/m2) Lenalidomide (mg) Vorinostat (mg) Dexamethasone (mg)
~15 15 300 40
~20 15 300 40
~20 25 300 40
~20/27* 25 300 40
~20/27* 25 400 40"
16212301|NCT01297738|Other|Meal size increase with HFHS|On top of a healthy, eucaloric diet, study subjects consume a 40% calory surplus by consuming a high-fat, high-sugar liquid medical food supplement (Nutridrink®). Subjects consume the Nutridrink® with their meals, which results in an increase in meal size.
16212302|NCT01297738|Other|Meal size increase with HS|On top of a healthy, eucaloric diet, study subjects consume a 40% calory surplus by consuming commercially available sugar-sweetened beverages. Subjects consume these sugar-sweetened beverages with their meals, which results in an increase in meal size.
16212303|NCT01297738|Other|Meal frequency increase with HFHS|On top of a healthy, eucaloric diet, study subjects consume a 40% calory surplus by consuming a high-fat, high-sugar liquid medical food supplement (Nutridrink®). Subjects consume the Nutridrink® 3 times a day in between meals, which results in an increase in meal frequency.
16212304|NCT01297738|Other|Meal frequency increase with HS|On top of a healthy, eucaloric diet, study subjects consume a 40% calory surplus by consuming commercially available sugar-sweetened beverages. Subjects consume these sugar-sweetened beverages 3 times a day in between meals, which results in an increase in meal frequency.
16212305|NCT01297725|Procedure|Blunt right, sharp left|Blunt fascial entry on the right side of the midline and sharp fascial entry on the left side of the midline.
16212306|NCT01297725|Procedure|Blunt left, sharp right|Blunt fascial entry on the left side of the midline and sharp fascial entry on the right side of the midline.
16212307|NCT01297712|Device|Latest generation colonoscopy as diagnostic instrument|this endoscope is used as compared to an older generations cope (classic line) currently in use
16212308|NCT01297699|Drug|Tocilizumab (RoActemra®)|Single intravenous infusion of tocilizumab (8 mg/kg); every 4 weeks during 16 weeks.
16212309|NCT01297699|Drug|Sterile 0.9% Sodium Chloride|Single intravenous dip infusion of a sterile 0.9% sodium chloride, every four weeks during 16 weeks.
16212310|NCT01297686|Other|Karaoke Exercise|lateral side step movement involving crossing one foot over the next for 5 sets of 15 cross-overs in each direction
16212311|NCT01297686|Other|Balance walking exercise|Walking along a straight line on the ground, for 5 sets of 30 strides
16212312|NCT01297686|Other|Forefoot extension exercise|The subject stands feet shoulder width apart with one foot ahead of the other and then contracting only calf muscles of the back leg, lifts the heel of the back leg until the metatarsophalangeal joint of that foot is maximally extended. The subject is instructed to concentrate on maintaining balance on the back leg over the first and second metatarsophalangeal joints throughout movement for 5 sets of 15 repetitions.
16212313|NCT01297686|Other|Standing one-legged balance exercise:|This exercise is performed initially with eyes open, then with mastery exhibited by being able to hold balance and not touch the ground with contralateral leg performed with eyes closed, then on an unstable surface with and without eyes open for 1 minute.
16212314|NCT01297686|Other|Ankle inversion/eversion exercise|The foot is placed sideways at the edge of a step. After stabilizing the remainder of the foot and leg, the ankle is inverted and everted to the limits of the range for 3 sets of 15 repetitions.
16212315|NCT01297686|Other|Gastrocnemius and soleus stretching|This stretch is performed while standing in a neutral position and the knee extended the foot is placed on top of a ramp or phone-book elevating the forefoot on the rearfoot (talocrural dorsiflexion) and held for 3 sets of 30 seconds each. Next the foot is again placed on top of a phone-book with the knee flexed approximately 15-20 degrees and held for 3 sets of 30 seconds each.
16212316|NCT01297686|Other|Tissue-specific plantar fascia self massage|This deep massage is performed in a sitting position the right foot is crossed over the left while one hand passively extends the right forefoot. The left hand then applies light to moderate pressure in 3-5 second intervals along the length of the medial longitudinal arch. Same procedure is then repeated for the left foot.
16212317|NCT01297686|Drug|Dexamethasone|"A 22-gauge, 1.5 needle and 3 cm syringe filled with 1ml of dexamethasone mixed with 0.5ml of 1% lidocaine. Prior to injection, the skin will be sterilized with povidone-iodine. The needle is inserted 2-3 cm anteromedial to the focal point of pain in the inferior heel near the calcaneal tuberosity and moved toward the tenderest area."
16212318|NCT01297673|Procedure|video-urodynamic examination|Assessment of bladder function during video urodynamic determine of incidence degree and localization of vesico ureteral reflux based on the result of video urodynamics
16212319|NCT01297660|Other|Video-urodynamic examination|
16212320|NCT01297647|Procedure|urodynamic examination|"Standard urodynamic investigation according to the ICS standard, Good urodynamic practice.Following insertion of 8 F transurethral catheter, retrograde filling of the bladder (20 mL/min) with body warm saline.
~Current recording of pabd. , pves and pdet., subsequently pressure flow study. Additionally imaging with fluoroscopy to detect possible vesico ureteral renal reflux."
16212321|NCT01297634|Drug|Botulinum Toxin Type-A (day 0)|"Botulinum Toxin Type-A 1 unit. Dilution:1U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.
~Botulinum Toxin Type-A 1 unit. Dilution: 0,5U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.
~Botulinum Toxin Type-A 1 unit. Dilution: 0,25U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle."
16212322|NCT01297634|Drug|Botulinum Toxin Type-A (day 0)|"Botulinum Toxin Type-A 2 Units. Dilution:1U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.
~Botulinum Toxin Type-A 2 units. Dilution: 0,5U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.
~Botulinum Toxin Type-A 2 units. Dilution: 0,25U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle."
16212323|NCT01297634|Drug|Botulinum Toxin Type-A (day 0)|"Botulinum Toxin Type-A 3 units. Dilution:1U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.
~Botulinum Toxin Type-A 3 units. Dilution: 0,5U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle.
~Botulinum Toxin Type-A 3 units. Dilution: 0,25U/0,01ml (with saline solution). will be injected in the left and right belly to the Frontal Muscle."
16212324|NCT01297621|Procedure|reduction mammaplasty|conventional reduction mammaplasty
16212325|NCT01297621|Other|control|follow up, questionnaire responses
16212326|NCT01297608|Drug|caoted suppository|coated suppository with active drug
16212327|NCT01297608|Drug|coated suppository|coated suppository with placebo
16212328|NCT01297595|Drug|crizotinib|Each subject will receive 250 mg single oral doses of oral liquid formulation and formulated capsule of crizotinib separated by at least 14 days.
16212329|NCT01297582|Drug|ONO-6950|1mg, 3mg, 10mg, 30mg,100mg,300mg,1000mg at a single dose; 30mg, 100mg and 300mg for food effect study
16212330|NCT01297582|Drug|ONO-6950|1mg, 3mg, 10mg, 30mg, 100mg, 300mg, 1000mg at a single dose; 30mg, 100mg and 300mg for food effect study
16212331|NCT01297569|Drug|Ranibizumab|
16212332|NCT01297556|Behavioral|Cognitive Behavior Therapy(CBT)|Cognitive Behavior Therapy(CBT) for 6 weeks.
16212333|NCT01297543|Biological|human myeloid progenitor cells|Single intravenous injection/infusion
16212334|NCT01297543|Drug|G-CSF|Background therapy
16212335|NCT01297530|Drug|BAY87-2243|Oral administration once daily in a continuous schedule. Starting dose will be 5 mg and dose will be escalated dependent on any dose limiting toxicities.
16212336|NCT01297517|Drug|Brinzolamide 1%/brimonidine tartrate 0.2% ophthalmic suspension|
16212337|NCT01297517|Drug|Brinzolamide ophthalmic suspension, 1%|
16212338|NCT01297517|Drug|Brimonidine tartrate ophthalmic solution, 0.2%|
16212339|NCT01297491|Drug|BKM120|Buparlisib was supplied as 10mg or 50mg capsules. It was administered on a continuous once daily dosing schedule at a dose of 100 mg. The patient was dosed on a flat scale of mg/day and not adjusted to body weight or body surface area.
16212340|NCT01297465|Drug|Gonal-f®|Gonal-f® (follitropin alfa) 300 International Unit (IU) will be administered subcutaneously once daily from stimulation day 1 (S1) to stimulation day 5 (S5).
16212341|NCT01297465|Drug|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU will be administered subcutaneously starting from S6 until recombinant human chorionic gonadotropin (r-hCG) administration day (at least 1 follicles >= 18 mm). The dose of Pergoveris® was adjusted based upon the participant's ovarian response and according to the site's standard practice.
16212384|NCT01297140|Behavioral|questioning|Patients will be screened by questioning them and their caregiver and from the results of the clinical examination and the biological and neuroradiological tests habitually carried out in cases of dementia and following accepted procedures.
16212342|NCT01297465|Drug|Pergoveris®|Pergoveris® (follitropin alfa and lutropin alfa) 300 IU will be administered subcutaneously once daily from S1 until r-hCG administration day (at least 1 follicles >= 18 mm). The dose of Pergoveris® was adjusted starting from S6 based upon the participant's ovarian response and according to the site's standard practice.
16212343|NCT01297465|Drug|Recombinant human chorionic gonadotropin (r-hCG)|250 microgram of r-hCG will be administered once subcutaneously on r-hCG day (at least 1 follicles >= 18 mm).
16212344|NCT01297452|Drug|BKM120 days 1 - 21 plus paclitaxel + carboplatin|Patients will receive oral daily BKM120 (days 1 - 21, per dose escalation scheme) plus paclitaxel (175 mg/m2 intravenously, day 1) + carboplatin (AUC 5 intravenously, day 1)on a 21-day cycle. Pegfilgrastim (6 mg/subcutaneously) will be administered on day 2 of each cycle.
16212345|NCT01297452|Drug|BKM120 (days 1 - 28, ) plus paclitaxel + carboplatin|Patients will receive oral daily BKM120 (days 1 - 28, per dose escalation scheme) plus paclitaxel (80 mg/m2 intravenously, days 1, 8 and 15) + carboplatin (AUC 5 intravenously, day 1) on a 28-day cycle.
16212346|NCT01297452|Drug|BKM120 (days 1-21) + paclitaxel (day 1) + carboplatin (day 1)|BKM120 100 mg (days 1 - 21, per dose escalation scheme) plus paclitaxel (200 mg/m2 intravenously, day 1) + carboplatin (AUC 6 intravenously, day 1) on a 21-day cycle. After enrollment to Groups 1 and 2 has been completed and all patients in Group 1 and 2 have completed the DLT monitoring period, up to 6 additional patients will be enrolled in this EXPANSION COHORT.A
16212347|NCT01297452|Drug|BKM120, Paclitaxel + Carboplatin|BKM120 100 mg per oral, days 1 - 21 Paclitaxel (175 mg/m2) intravenously on Day 1 Carboplatin (AUC 5) intravenously on Day 1 EXPANSION COHORT B
16212348|NCT01297439|Procedure|suctioning of fetal nose and mouth during delivery|"Normal delivery without pushing maneuver: either an expectative attitude or a suctioning of fetal nose and mouth during delivery, since the crowning of the head (appearance of the fetal scalp at the introitus between pushes)."
16212349|NCT01297439|Procedure|Pushing maneuver|"The pushing maneuver is performed gently on the fetal head since the crowning of the head (appearance of the fetal scalp at the introitus between pushes), during one uterine contraction, aiming to facilitate the anterior shoulder to slip off behind the symphysis pubis, reducing thus the risk of shoulder dystocia."
16212350|NCT01297413|Biological|Allogeneic adult mesenchymal bone marrow stem cells|Patients will receive intravenously one dose of 0.5-1.5 million cells per kg of allogeneic adult mesenchymal bone marrow stem cells
16212351|NCT01297400|Drug|MW-III|Topical application, Twice a day
16212352|NCT01297400|Procedure|Silver Sulfadiazine|Topical Application, Twice a day
16212353|NCT01297387|Other|PTA BPG procedure,|Surgery PTA or BPG Procedure, according usual local clinical practice
16212354|NCT01297374|Behavioral|physical activities, dietician counseling and behavioral changes|One arm receive an schedule for physical activities. One arm receive a diet prescription. One arm receive general guidance on diet, physical activity and behavioral changes
16212355|NCT01297361|Other|Blood Sample|Blood sampling for diagnosis of vitamins deficiencies
16212356|NCT01297348|Drug|90ug levonorgestrel / 20 ug ethinyl estradiol|This is a non-interventional observational database study, thus no interventions are offered to patients in the study.
16212357|NCT01297348|Drug|Oral Contraceptives containing 20 ug of ethinyl estradiol|This is a non-interventional observational database study, thus no interventions are offered to patients in the study.
16212358|NCT01297335|Drug|clonidine|Intrathecal Clonidine
16212359|NCT01297322|Other|Manual compression|Standard of Care
16212360|NCT01297322|Device|Cardiva VASCADE™ Vascular Closure System|Investigational Hemostatic Vascular Closure System
16212361|NCT01297309|Drug|NPSP558|All patients will inject NPSP558 individual titration of 25, 50, 75 or 100 μg SC QD into alternating thighs in the morning via a multidose injection pen device.
16212362|NCT01297283|Other|LECG first|Measurement of the pacing threshold with the support of a leadless ECG
16212363|NCT01297283|Other|Programmer ECG first|Pacing threshold measurements are done with the support of the programmer ECG
16212364|NCT01297270|Drug|BI201335|QD BI 201335
16212365|NCT01297270|Drug|PegIFN/RBV|
16212366|NCT01297270|Drug|BI201335|QD (once daily) BI 201335
16212367|NCT01297270|Drug|Placebo|
16212368|NCT01297257|Device|Stent implantation|Single arm, open label stent implantation
16212369|NCT01297244|Drug|Tivozanib|Subjects will receive 1.5 mg tivozanib once daily beginning on Day 1 for 3 weeks followed by 1 week off treatment. One cycle will be defined as 4 weeks of treatment. Cycles will be repeated every 4 weeks.
16212370|NCT01297231|Other|MRI|"Baseline Breast-MRI within 1 year before starting tamoxifen (allows for surgery, chemotherapy and radiation before the start of tamoxifen).
~During Tamoxifen Treatment:
~Blood will be drawn for CYP2D6 genotype testing. Analysis of samples will be performed internally at MSKCC.
~Follow-up breast MRI after 9-12 months of tamoxifen therapy. In patients whom further breast MRI screening and/or follow-up is clinically indicated, follow-up breast MRIs may be performed within 3 months (before or after) the 2, 3, and 4 year time points during tamoxifen treatment. All breast MRIs will be performed using the same technique.
~Follow-up for all patients during and after tamoxifen should include routine standard clinical assessment and imaging such as mammography and breast MRI when clinically indicated."
16212371|NCT01297218|Biological|Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells|DOSE A - 250,000 cells per 5 uL per 1 entry site, 3 million cells per brain DOSE B - 500,000 cells per 5 uL per 1 entry site, 6 million cells per brain
16212372|NCT01297205|Biological|Human Umbilical Cord Blood Derived-Mesenchymal Stem Cells|Dose A - 10 million cells per kg Dose B - 20 million cells per kg Single intratracheal administration
16212373|NCT01297192|Drug|solifenacin succinate|Oral
16212374|NCT01297192|Drug|mirabegron|Oral
16212375|NCT01297179|Drug|Mirabegron|Oral
16212376|NCT01297179|Drug|Minidril|Oral
16212377|NCT01297179|Drug|Placebo|Oral
16212378|NCT01297166|Drug|LEO 27989 ointment|once daily application, 3weeks
16212379|NCT01297166|Drug|Calcipotriol plus LEO 27989 ointment|once daily application, 3weeks
16212380|NCT01297166|Drug|Calcipotriol ointment|once daily application, 3weeks
16212381|NCT01297166|Drug|Vehicle ointment|once daily application, 3weeks
16212382|NCT01297153|Device|Intraocular Lens (Acrysof IOL)|IOL fixation, material and size are important determinants of immediate and long-term outcome. In-the-bag fixation is the most preferred site of IOL implantation.
16212385|NCT01297114|Drug|Florbetaben|This is a purely observational study. Results of the Florbetaben PET scan will be correlated with other observations.
16212386|NCT01297101|Drug|Erlotinib|150mg/qd, on day 15-28 of each 28 day cycle.
16212387|NCT01297088|Drug|BAY86-9596|One single dose administration of a diagnostic agent
16212388|NCT01297075|Behavioral|Outreach visits|The 16 facilitators in the project attend an educational programme designed to provide them with the necessary skills and tools for the task. The facilitators visit general practice clinics from March 2011 until the end of 2012. Each clinic is offered three visits. The facilitator is to act as a change agent who motivates and helps the clinic team in the process of defining common goals, and choosing the appropriate means for achieving them.
16212389|NCT01297062|Drug|Exenatide|IV Exenatide (therapeutic and supratherapeutic concentrations)
16212390|NCT01297062|Drug|Moxifloxacin|Oral Moxifloxacin (400 mg)
16212391|NCT01297062|Drug|Placebo comparator|IV Placebo (matching volume of placebo)
16212392|NCT01297049|Behavioral|Cognitive behavior therapy (CBT)|All patients will receive standard care (reassurance, education, physiotherapy, and necessary medication). Complementary to this standard care, the participants will be required to closely monitor their blood glucose levels, weight, eating behavior and daily activities, and to relay this information to the nurse specialist trained in treating somatic patients with CBT. The nurse will then suggest appropriate treatment decisions, the patients will receive situational feedback based on the electronic diary during 3 months (daily during 4 weeks intensive treatment and weekly during 2 months as a complement).
16212393|NCT01297036|Drug|Donepezil, ODT 10 mg|Test- Donepezil Hydrochloride 10 mg Tablet single dose
16212394|NCT01297036|Drug|Donepezil, 10 mg tablet|Reference: Donepezil Hydrochloride 10 mg Tablet
16212395|NCT01297023|Dietary Supplement|calcium phosphate|20 subjects consume for 8 weeks a bread enriched with calcium phosphate [1g calcium/d]
16212396|NCT01297023|Dietary Supplement|vitamin d|20 subjects consume for 8 weeks a bread with vitamin d3 [10µg/d]
16212397|NCT01297023|Dietary Supplement|calcium phosphate and vitamin d|20 subjects consume for 8 weeks a bread enriched with calcium phosphate [1g calcium/d] and vitamin d3 (10µg/d]
16212398|NCT01297023|Other|placebo|All participants consume two weeks before intervention a bread without calcium an vitamin d.
16212399|NCT01297010|Drug|Dexamethasone and ondasetron|Patients will receive ondansetron (0.1 mg / kg dose of 4mg cap) associated with dexamethasone (0.15 mg / kg dose of 5mg ceiling) or dexamethasone (0.15 mg / kg) or placebo
16212400|NCT01297010|Drug|Dexamethasone|Children were randomized to this group ni initiate proceedings with a 10ml syringe containing dexamethasone (0.15 mg / kg dose of 5mg ceiling)
16212401|NCT01296997|Dietary Supplement|calcium phosphate|the subjects consumed for 3 weeks a bread enriched with 1 g pentacalcium phosphate per day
16212402|NCT01296997|Other|placebo|the subjects consumed a bread without pentacalcium phosphate
16212403|NCT01296971|Drug|peginterferon alfa-2a [Pegasys]|180 mcg sc weekly
16212404|NCT01296971|Drug|ribavirin [Copegus]|1'000/1'200 mg daily orally, 24 - 72 weeks
16212405|NCT01296971|Drug|ribavirin [Copegus]|800 mg daily orally, 16 - 48 weeks
16212406|NCT01296958|Drug|Niclosamide|Single oral dose of niclosamide determined by weight (dose: 11 to 34kg receive 1 gram, 35 to 50kg receive 1.5 grams, over 50kg receive 2 grams)
16212407|NCT01296958|Behavioral|Community education campaign|Education about prevention of Taenia solium infection provided in a single short (20 minute) interaction with the participant. Education was verbal with visual aids.
16212408|NCT01296945|Other|Kiosk|Touchscreen computer containing three educational modules in Spanish on infant/toddler juice intake, milk, and solid/foods
16212409|NCT01296945|Other|paper|Participants will receive a paper handout with nutrition educational information.
16212410|NCT01296945|Other|Kiosk PLUS paper|Individuals will use the 3 computer modules on a touchscreen and receive the information on a paper handout.
16212411|NCT01296945|Other|Kiosk PLUS web|Participants will utilize the 3 modules on the touchscreen computer and be given a piece of paper that includes information on how to see this information again on the internet. Participants will be asked to view the modules on the web.
16212412|NCT01296932|Drug|BI 836826|Monotherapy with BI 836826 at escalating dose levels administered as an intravenous infusion.
16212413|NCT01296906|Behavioral|Recall conducted by private practices|All practices in these counties will receive training on practice-based R/R using the Colorado Immunization Information System (CIIS or immunization registry). Practices will receive a recommended schedule for conducting recall in 19-35 month children and educational materials to use within their practices to promote compliance with the infant vaccination schedule. Individual practices will make their own decisions about the extent to which they follow the recommendations and implement recall within their practice. Although the study team will not provide them with any additional interventions, we will track any other interventions they independently do (websites, newsletters, telephone informational systems) in order to assess the effect of these additional interventions.
16212414|NCT01296906|Behavioral|Recall conducted centrally by local health department|A centralized recall of children 19-35 months will be conducted through local health departments. CIIS will identify a cohort of 19-35 month olds with an who are in need of an immunization and will coordinate up to 3 mailers to children who are not current for recommended immunizations.
16212415|NCT01296893|Behavioral|Exercise|150 minutes/week of aerobic exercise at 60-70% of heart rate reserve (individualized based on baseline VO2 peak test). The intervention is 24 weeks with an exercise progression to reach the full exercise prescription by week 8. Participants are required to attend two 45 minute supervised sessions per week and complete two additional 30 minute sessions independently at home.
16212416|NCT01296854|Other|Spa therapy|3 weeks of spa therapy
16212417|NCT01296841|Device|Collaborative Imaging|Hardware and software communication tools to provide clinical care from a distance.
16212418|NCT01296815|Drug|Bevacizumab|Intralesional bevacizumab, dosis of 5mg/cm2, injections every 2 weeks, total number of injections: 3
16212419|NCT01296802|Drug|dexfenfluramine|oral, 40 mg to 60 mg, single application as a challenge
16212420|NCT01296789|Other|Tissue perfusion guided protocol|A tissue perfusion guided protocol is used to guide hemodynamic therapy
16212421|NCT01296789|Other|Usual Care|Usual Care
16212730|NCT01294384|Drug|carboxymethylcellulose sodium based Eye Drops|1 to 2 drops of carboxymethylcellulose sodium based Eye Drops (Refresh Tears®) in each eye at least twice daily for 90 days.
16212422|NCT01296776|Other|wellness control group.|Light physical exercise and relaxation program once a week in blocks of 10 weeks with breaks of 10 weeks between the blocks. The low-intensity, low-volume program was designed to avoid impact on our endpoints.
16212423|NCT01296776|Device|whole-body electromyostimulation|3 sessions of 18 min/14 (1,5 x week)days over 12 months. 10 low-intensity/low amplitude exercises with electromyostimulation equipment with 85 Hz with periods of 6 sec of current and 4 sec of rest.
16212424|NCT01296763|Drug|Irinotecan|Irinotecan 70 mg/m2 IV, Days 1 and 8
16212425|NCT01296763|Drug|Cisplatin|Cisplatin 25 mg/m2 IV, Days 1 and 8
16212426|NCT01296763|Drug|Olaparib (for levels 1 and 5)|Olaparib 100 mg bid oral, Days 1 and 8
16212427|NCT01296763|Drug|Olaparib (for dose level 2)|Olaparib 100mg bid oral, Day 1-3, Day 8-10
16212428|NCT01296763|Drug|Mitomycin-C|Mitomycin 5 mg/m2 IV, Day 1
16212429|NCT01296750|Other|Early Physiotherapy start|Physiotherapy starting at one day post op
16212430|NCT01296724|Other|Measure of intravesical pressure|For the installation of the urinary catheter, a valve connected to a pressure head is intercalated between the probe and the collecting bag. Various Intravesical pressure measurements will be conducted after injection of 0 ml/kg, 0.5 ml/kg, 1 ml/kg, 1.5 ml/kg, 2 ml/kg, 2.5 ml/kg 3 ml/kg, 3.5 ml/kg and 4 ml/kg of physiological saline.
16212431|NCT01296724|Other|Measure of intravesical pressure|For the installation of the urinary catheter, a valve connected to a pressure head is intercalated between the probe and the collecting bag. Various IVP measurements will be conducted after injection of 0 ml/kg, 0.5 ml/kg, 1 ml/kg, 1.5 ml/kg, 2 ml/kg, 2.5 ml/kg 3 ml/kg, 3.5 ml/kg and 4 ml/kg of physiological saline.
16212432|NCT01296711|Biological|CDP6038|100mg/ml solution for injection 120 mg subcutaneously (sc) every 2 weeks
16212433|NCT01296698|Drug|Placebo|Dosage Form: Oral NRT; Dose: 0 mg; Frequency: up to 4 times per hour; Duration: 12 weeks
16212434|NCT01296698|Drug|Nicotine|Dosage Form: Oral NRT; Dose: 1 mg;Frequency: up to four times per hour; Duration:12 weeks
16212435|NCT01296672|Drug|Finasteride|Finasteride 5mg every day by mouth for 3 months
16212436|NCT01296672|Drug|Placebo|Placebo every day by mouth for 3 months
16212437|NCT01296659|Drug|ridaforolimus|Ridaforolimus administered orally 5 days per week in combination with standard chemotherapy
16212438|NCT01296646|Drug|Naltrexone|50 mg oral naltrexone once/day
16212439|NCT01296646|Behavioral|Brenda Therapy Sessions|participants will meet with a trained therapist for nine 30-minute BRENDA therapy sessions Medical monitoring will also be conducted by study physicians and will consist of review of vital signs, concomitant medication use, and general inquiries into side effects.
16212440|NCT01296646|Drug|Placebo|An inactive pill to control for non-pharmacological responses.
16212441|NCT01296633|Behavioral|Medtable|Nurse works with patient to reconcile EMR-based medication list and load list into Medtable. Nurse uses Medtable with patient to develop plans for taking medications. Patient completes Medtable columns to identify when routine activities are performed during the day. Nurse discusses medications with patient: what the medication is called, used for, etc. Nurse and patient jointly develop the schedule by choosing times to take each medication. These times are entered into corresponding cells of the Medtable. Nurse corrects any mistakes (e.g., times that would conflict with dose spacing requirements). Nurse asks patient to review to ensure patient understands key facts and that drug interactions or other restrictions are addressed, using collaborative inquiry, teach-back, and teach-to-goal strategies. Patient takes home a hardcopy of the Medtable schedule to guide adherence. An updated e-copy is integrated with patient's record in the EMR.
16212442|NCT01296620|Drug|Ulimorelin Intravenously (IV)|160 µg/kg daily (QD)
16212443|NCT01296620|Drug|Ulimorelin Invtravenously (IV)|480 µg/kg daily (QD)
16212444|NCT01296620|Drug|5% dextrose in water|Placebo
16212445|NCT01296607|Drug|Urocortin 2|"Protocol 4a: Onset/Offset protocol: (Visits 1 or 3)
~Following a 20-minute period of saline infusion for equilibration of the set-up, subjects will receive incremental doses of Urocortin 2 in the presence of a saline washout between each dose.
~Urocortin 2 will be infused at 3.6, 12, 36 and 120 pmol/min (15, 50, 150 and 498 nanograms/min) to achieve estimated end-organ concentrations of 0.6, 2, 6 and 20 micrograms/L respectively.
~Protocol 4b: Reproducibility protocol (Visit 2 or 4)
~Following a 20-minute period of saline infusion for equilibration of the set-up, subjects will receive ascending doses of urocortin 2 in the absence of saline washout between each dose. This protocol aims to assess the reproducibility of the vasodilatory effect of urocortin 2 on repeated dosing. The doses used for this protocol will be identical to Protocol a."
16212446|NCT01296607|Drug|Urocortin 3|"Protocol 4a: Onset/ Offset protocol: (Visit 1 or 3)
~Following a 20-minute period of saline infusion for equilibration of the set-up, subjects will receive incremental doses of Urocortin 2 or Urocortin 3 in the presence of a saline washout between each dose.
~Urocortin 3 will be infused at 1200, 3600, 12000 and 36000 pmol/min (5, 15, 50 and 150 micrograms/min) to achieve estimated end organ concentrations of 199, 600, 2000 and 6000 micrograms/L respectively.
~Protocol 4b: Reproducibility protocol (Visit 2 or 4)
~Following a 20-minute period of saline infusion for equilibration of the set-up, subjects will receive ascending doses of urocortin 3 in the absence of saline washout between each dose. This protocol aims to assess the reproducibility of the vasodilatory effect of 3 on repeated dosing. The doses used for this protocol will be identical to Protocol a."
16212447|NCT01296594|Other|Usual Care|Usual Care
16212448|NCT01296594|Behavioral|Contingency Management|This intervention consists of congratulatory messages or reminders about adherence, and participants will earn vouchers each time medication ingestion occurs at the appropriate time, along with bonuses for sustained adherence.
16212449|NCT01296581|Drug|X-82|Dose escalation starting at 20 mg, oral once or twice a day, 28 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
16212450|NCT01296568|Drug|LY2603618|Administered intravenously
16212451|NCT01296568|Drug|Pemetrexed|Administered intravenously
16212452|NCT01296568|Drug|Gemcitabine|Administered intravenously
16212453|NCT01296555|Drug|Fulvestrant|Participants will receive fulvestrant 500 milligrams (mg) via intramuscular injection (as per package insert or Summary of Product Characteristics [SmPC]) on Days 1 and 15 of Cycle 1, then on Day 1 of each subsequent cycle, until disease progression (Cycle length: 28 days).
16212680|NCT01294696|Drug|Standard of care for treatment of osteoarthritis (OA) of knee(s)|All participants will be treated according to standard medical guidelines or usual clinical practice standards of the investigating physician.
16212454|NCT01296555|Drug|GDC-0032|Participants will receive GDC-0032 at escalating (Phase I, Stage 1) or fixed (Phase II and Phase I, Stage 2) doses until disease progression. Cycle 1 may be 35 days in length to allow for a 7-day washout following the initial dose; thereafter, GDC-0032 will be administered orally once daily in 28-day cycles.
16212455|NCT01296555|Drug|Letrozole|Participants will receive letrozole 2.5 mg orally (as per Package Insert or SmPC) once daily in 28-day cycles until disease progression.
16212456|NCT01296555|Drug|Midazolam|Participants will receive midazolam 5 mg (as per Package Insert or SmPC) in hydrochloride syrup on Days 1 and 16 of Cycle 1.
16212457|NCT01296542|Drug|Moxifloxacin Ophthalmic|
16212458|NCT01296542|Drug|Besifloxacin Ophthalmic|
16212459|NCT01296516|Behavioral|Non-intervention group|A pedometer and written material on a healthy lifestyle.
16212460|NCT01296516|Behavioral|Face to face|Motivational meetings held once per week; Behavioral sessions weill be led by a trained interventionist.
16212461|NCT01296516|Behavioral|Telehelath Group|Participants will speak to Trestletree personnel once a week via phone.
16212462|NCT01296503|Drug|Thalidomide plus dexamethasone|"D+60 after ASCT: randomization in two arms of maintenance: Arm A (dexamethasone alone 40 mg/day for 4 days every 28 days) and Arm B (dexamethasone plus thalidomide 200 mg by mouth daily) for 12 months or until disease progression.
~The dose of thalidomide could be reduced if the patient experienced grade 2 or higher adverse events. In this case, thalidomide was discontinued and re-challenged at a lower dose after resolution of the adverse event."
16212463|NCT01296503|Drug|Dexamethasone|dexamethasone alone 40 mg/day for 4 days every 28 days
16212464|NCT01296490|Other|Stress test|Stress test while running on a treadmill until exhaustion for 8-12 minutes. Blood will be drawn before, 5 minutes after and an hour after the test.
16212465|NCT01296464|Drug|Carbidopa|Capsules
16212466|NCT01296451|Biological|MVA-NSmut|Genetic vaccine against Hepatitis C virus infection
16212467|NCT01296451|Biological|AdCh3NSmut|genetic vaccine against Hepatitis virus infection
16212468|NCT01296451|Biological|AdCh3NSmut1|genetic vaccine against Hepatitis virus infection
16212469|NCT01296438|Drug|Faster-acting insulin aspart|Single dose of 0.2 U/kg body weight faster-acting insulin aspart injected subcutaneously (under the skin) followed by single dose of 0.2 U/kg body weight insulin aspart injected subcutaneously (under the skin)
16212470|NCT01296438|Drug|insulin aspart|Single dose of 0.2 U/kg body weight insulin aspart injected subcutaneously (under the skin) followed by single dose of 0.2 U/kg body weight faster-acting insulin aspart injected subcutaneously (under the skin)
16212471|NCT01296425|Device|Easypod™|Saizen (Somatotropin) as per Summary of Product Characteristics administered by Easypod™
16212472|NCT01296412|Drug|sitagliptin|100 mg tablet, orally, once daily.
16212473|NCT01296412|Drug|liraglutide|0.6 mg by subcutaneous (pen) injection, once daily, on Days 1-7; up-titrated on Day 8 to 1.2 mg daily. At Week 12, dose may be increased to 1.8 mg once daily for participants who did not meet protocol-specified glycemic goals.
16212474|NCT01296412|Drug|glimepiride|starting dose of 1 mg tablet (up-titrated as needed), once daily, as needed, after Week 12.
16212475|NCT01296412|Drug|metformin|metformin tablets at a dose of ≥1500 mg per day
16212476|NCT01296386|Biological|IC84|IC84, a recombinant fusion protein consisting of truncated Clostridium difficile (C. difficile) Toxin A and Toxin B, which will be administered at two different doses: 75 and 200 µg without or with Al(OH)3, respectively, intramuscular (i.m.) injection, four vaccinations on Day 0, 7, 28 and 56.
16212477|NCT01296360|Biological|IXIARO|0.25 ml i.m. (milliliter, intramuscular)
16212478|NCT01296360|Biological|IXIARO|0.5 ml i.m. (milliliter, intramuscular)
16212479|NCT01296347|Drug|Ketamine|Intravenous infusion of ketamine starting 10 minutes prior to surgery and running for 96 hours, which will be administered at a rate of 0.1mg/kg/hour. A loading dose of 0.1mg/kg will be administered prior to the start of the infusion
16212480|NCT01296334|Drug|morphine LO|intravenous infusion, 10 mg, once, 4 hours
16212481|NCT01296334|Drug|Morphine Hi|intravenous infusion, 20 mg, once, 4 hours
16212482|NCT01296334|Drug|Buprenorphine LO|intravenous infusion, 0.3 mg, once, 4 hours
16212483|NCT01296334|Drug|Buprenorphine Hi|intravenous infusion, 0.6 mg, once, 4 hours
16212484|NCT01296334|Other|saline|intravenous infusion, 0.9% saline, once, 4 hours
16212485|NCT01296321|Behavioral|Tailored Internet-administrated CBT-Treatment|"This intervention contains 6-8 text-based self-help modules in which 4 modules are fixed (the first three and the last) and the rest are prescribed following the diagnostic telephone interview. These modules contain material on panic disorder, social phobia, stress management, assertiveness training, concentration, relaxation among other things."
16212486|NCT01296321|Behavioral|Waitlist|Passive waitlist during 8-10 weeks.
16212487|NCT01296308|Other|inpatient integrative treatment|two weeks inpatient integrative therapy: conventional medicine, traditional European and Chinese medicine (TCM), mind-body medicine, physical therapy, lifestyle modification program: nutrition advices, stress management, exercise training
16212488|NCT01296295|Behavioral|Lifestyle counseling and spirometry|The patients of the intervention group will be given a brief structured smoking cessation advice by their primary care physician combined with a detailed and structured discussion of the spirometry results.
16212489|NCT01296295|Behavioral|Smoking cessation advice|Brief smoking cessation advice
16212490|NCT01296282|Device|Medronics CRT Optivol Impedance Measurement|Pacemaker
16212491|NCT01296282|Device|External Thoracic Impedance Measurement|
16212492|NCT01296269|Drug|Oxytocin|one-time intranasal administration, 24 International Units, 5 puffs for each nostril
16212493|NCT01296269|Drug|Arginine Vasopressin|one-time intranasal administration, 20 International Units, 5 puffs in each nostril
16212494|NCT01296269|Drug|placebo|contains all the ingredients as in the oxytocin and vasopressin conditions, save for the active ingredient, one time intranasal administration, 5 puffs in each nostril
16212495|NCT01296256|Drug|Bendamustine-EAM|Bendamustine 200 mg/m2 starting dose on day -7 and -6 Etoposide 200 mg/m2 from day -5 to day -2 Ara-C 400 mg/m2 from day -5 to day -2 Melphalan 140 mg/m2 on day -1
16212681|NCT01294683|Drug|Simvastatin|
16212682|NCT01294683|Drug|Extended Release (ER) niacin/laropiprant/simvastatin (N/LRPT/SIM)|
16212683|NCT01294683|Drug|Extended Release (ER) niacin/laropiprant (N/LRPT)|
16212496|NCT01296243|Drug|Tesetaxel|Tesetaxel capsules will be administered orally once every 21 days until progression, as defined by Prostate Cancer Working Group 2 (PCWG2) criteria. The duration of protocol therapy will not exceed 12 months. Treatment will be initiated at a dose of 27 mg/m2; dose escalation to a maximum of 35 mg/m2 is allowed in Cycle 2 depending on tolerability.
16212497|NCT01296230|Procedure|Hormone and semen measurements before varicocelectomy|Before surgery we will measure sex-hormone levels and semen parameters. This will be repeated after the varicocelectomy to record any changes.
16212498|NCT01296217|Procedure|lymph nod detection|
16212499|NCT01296204|Drug|BB4 antibody-Iodine 131|Injection of an antibody after labelling with Iodine 131
16212500|NCT01296191|Drug|Moxifloxacin|One drop 4 times daily for 3 days and one drop the day of sample collection
16212501|NCT01296191|Drug|besifloxacin|One drop 4 times daily for 3 days and one drop on day of sample collection
16212502|NCT01296178|Drug|IDARUBICINE|"Administration of chemotherapy induction
~Idarubicin IV Dose of 12 mg/m2/day days 1 to 3"
16212503|NCT01296178|Drug|ARA-C|ARA-C 200 mg/m2/day dose continuous infusion of IV days 1 to 7
16212504|NCT01296165|Behavioral|Analysing the behaviours of travellers while visiting India|For analyses surrounding the risks for acquisition comparisons between those who acquire ESBLs and those who do not, will be made using Stata version 9.0 (Stata Corp, College Station, TX). Differences in proportions among categorical data will be assessed using Fisher's exact test for pair-wise comparisons. Student T-test or Mann-Whitney U tests will be used for comparing means and medians. For all statistical comparisons a p-value <0.05 will be deemed to represent statistical significance.
16212505|NCT01296152|Drug|depo-medroxyprogesterone acetate|At study entry/ Day 0, participants will receive Depo-medroxyprogesterone (DMPA) 150mg administered intramuscularly (IM) as a single-dose.
16212506|NCT01296139|Drug|Ferumoxytol|All subjects will undergo pre-injection, 24, 48 hours post-Ferumoxytol injection (dose of 7.5mg/kg Fe) MRI consisting of T1 weighted (W), T2W and T2*W MRI in a 3 Tesla magnet. Additionally, all subjects will undergo pre-injection, 24 hours, 48 hours post-Ferumoxytol injection (dose of 7.5mg/kg Fe) ultrasound.
16212507|NCT01296113|Drug|Chemotherapy|"Pemetrexed + Carboplatin
~On D1 of a 21-day cycle:
~Pemetrexed 500 mg/m² IV in 10 minutes followed 30 minutes later by:
~Carboplatin AUC 5 in 30 minutes in 100 ml sterile water or 5% glucose or physiological serum. The carboplatin dose will be calculated by the Calvert formula with a target AUC of 5 mg/mL.min as follows:
~Carboplatin dose in mg = 5 x (GFR + 25) GFR is estimated according to the MDRD equation for creatinine clearance
~• 4 cycles total"
16212508|NCT01296100|Behavioral|Lifestyle intervention (nutrition)|The 200 study participants of this arm will first receive 6 months of Nutritional counseling and thereafter combined nutrition/physical activity counseling during 18 month. The counseling sessions consists of monthly group seminars (10 participants/group) and totally 6 individual visits with a nutritionist and 6 visits with a physical activity expert.
16212509|NCT01296100|Behavioral|Lifestyle intervention (physical activity)|The 200 study participants of this arm will first receive 6 months of physical activity counseling and thereafter combined nutrition/physical activity counseling during 18 month. The counseling sessions consists of monthly group seminars (10 participants/group) and totally 6 individual visits with a nutritionist and 6 visits with a physical activity expert.
16212510|NCT01296087|Drug|TC-6987|TC-6987 50 mg capsule given once daily on Days 1 to 28
16212511|NCT01296087|Drug|Placebo|Matching placebo capsule given once daily on Days 1 to 28
16212512|NCT01296074|Drug|Corticosteroid|500mg Methylprednisolone will be in the priming of cardiopulmonary bypass.
16212513|NCT01296048|Device|Comparison test|Scaleman Body Fat Scales, FS-148BW1, accuracy: ±0.1kg and range: 0-180kg.
16212514|NCT01296035|Biological|Panitumumab|Panitumumab 2.5 mg/kg on D1, D8, D15, and D22 and Gemcitabine 800 mg/m2 on D1, D8, and D15 of each 28 day cycle.
16212515|NCT01296022|Device|Implantation of subcutaneous ICD|Implantation of subcutaneous ICD
16212516|NCT01296022|Device|Implantation of transvenous ICD|Implantation of transvenous ICD
16212517|NCT01296009|Drug|Traditional Chinese medicine(Zhuyun Recipe)|The patients undergoing IVF-ET take orally traditional Chinese medicine(Zhuyun Recipe) for ten days.
16212518|NCT01295970|Procedure|Surgery|Prior to surgery, patients will have placement of scalp fiducials and undergo a contrast enhanced MRI scan. Once the patient is anesthetized or sedated, the head will be secured with a head frame and scalp fiducials will be registered to the stereotactic neuronavigation system. The tumor will then be resected and the patient will be taken to the recovery unit.
16212519|NCT01295970|Procedure|Stereotactic Radiosurgery|This will be delivered using Gamma Knife technology. Patients randomized to this arm will be fitted with a stereotactic head-frame for stereotactic localization of brain metastases.
16212520|NCT01295957|Behavioral|reminiscence therapy|24 bi-weekly sessions of reminiscence therapy, lasting one hour each one, over a period of 12 weeks. The latter refers to the use of images, sentences or memorabilia which help to focus on specific segments of the life history of an individual, and stimulates the emergence of affect-laden personal recalls, which are later verbalized in the context of guided conversations12. The term story life is intended to highlight samples of meaningful events of the subject's life rather than a historically structured biography13. Three main variables contributed to reminiscing: individuality, evaluation and structure.
16212521|NCT01295957|Behavioral|comparison group|The control group was administered counseling and informal social contacts in bi-weekly sessions of one hour, common subjects addressed by comparison group were social security incomes, diets, family visits.
16212522|NCT01295957|Other|control|advise and informal counseling
16212684|NCT01294683|Drug|Placebo|
16212777|NCT01293968|Drug|Ibuprofen, Diphenhydramine and Aluminium MgS|3 times daily for 3 days
16212778|NCT01293968|Drug|Diphenhydramine and Aluminium MgS|3 times daily for 3 days
16212525|NCT01295931|Drug|Indocyanine Green (IC-Green)|5 intradermal injections, 25 µg IC-Green in 0.1 mL of saline, in locations on the extremity (i.e. arm or leg) correlating with the tumor draining nodal basin to begin. Corresponding injections performed on the contralateral limbs.
16212526|NCT01295931|Procedure|Imaging|Nonradioactive optical imaging with indocyanine green as a fluorescent contrast agent prior to sentinel lymph node biopsy or lymph node surgery.
16212527|NCT01295918|Dietary Supplement|L reuteri in children on antibiotics|Each patient will be assigned to receive either a probiotic supplement containing 1 x 10 8 CFU Lactobacillus reuteri DSM 17938 in the form of one chewable tablet once per day (BioGaia AB, Stockholm, Sweden) or placebo, identical in taste and appearance. The probiotic or placebo will be taken 2 hours after lunch each day, during the entire period of antibiotic treatment and for an additional 7 days.
16212528|NCT01295905|Device|delefilcon A contact lens|Investigational silicone hydrogel, single vision soft contact lens
16212529|NCT01295905|Device|narafilcon B contact lens|Commercially marketed silicone hydrogel, single vision soft contact lens
16212530|NCT01295892|Drug|Estrogen|transdermal 17-β-estradiol 1mg/day during three months
16212531|NCT01295879|Drug|Ergocalciferol|Ergocalciferol 50,000 IU's orally per week, for 8 weeks
16212532|NCT01295866|Device|nasal nitric oxide|
16212533|NCT01295853|Procedure|t3 sympathicotomy|The sympathetic chain was identified at the level of the crossing of the third or fourth costal heads after dissection of the parietal pleura and completely divided about 1 cm wide at the upper margin of the rib. With assistance of anaesthesia team we reinflate the lung totally in sequence with removal of the trocars. The same procedure was performed on the opposite side and ablation of the sympathetic chain overlying the rib was performed bilaterally. At the end of surgery, a postoperative chest x-ray was routinely taken to rule out pneumothorax or hemothorax.
16212534|NCT01295853|Procedure|t4 symapthicotomy|The sympathetic chain was identified at the level of the crossing of the third or fourth costal heads after dissection of the parietal pleura and completely divided about 1 cm wide at the upper margin of the rib. With assistance of anaesthesia team we reinflate the lung totally in sequence with removal of the trocars. The same procedure was performed on the opposite side and ablation of the sympathetic chain overlying the rib was performed bilaterally. At the end of surgery, a postoperative chest x-ray was routinely taken to rule out pneumothorax or hemothorax.
16212535|NCT01295840|Device|Cardiac Resynchronization Therapy Defibrillator|Cardiac Resynchronization Therapy Defibrillator
16212536|NCT01295827|Biological|Pembrolizumab|IV infusion over 30 minutes on Day 1 of each cycle, administered according to dose selection or randomization.
16212537|NCT01295814|Drug|Adalimumab|80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
16212538|NCT01295814|Other|inactive drug|80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period
16212539|NCT01295788|Device|Simultaneous RT-CGM and Pump Initiation|Subjects in this group will start using RT-CGM at the same time as they initiate insulin pump therapy.
16212540|NCT01295788|Device|Delayed Initiation of RT-CGM|Subjects in this group will start using RT-CGM 6 months after initiation of insulin pump therapy.
16212541|NCT01295775|Drug|sulodexide|"A (SULODEXIDE GROUP):
~50 mg a day by oral route (1+1 capsules/day) for 360 days
~B (PLACEBO GROUP):
~Sulodexide placebo at the same schedule dosage and for the same lengths of time as group A."
16212542|NCT01295762|Other|Immunological analyses|Immunological analyses will be done on blood, bone marrow and tumor samples, at diagnosis, and during the treatment of children diagnosed for neuroblastoma (up to 3 time points). These types of samples are routinely done during conventional neuroblastoma treatment.
16212543|NCT01295749|Device|laryngeal tube ventilation and continuous chest compression|Comparison of no flow time between two strategies in out of hospital cardiac arrest
16212544|NCT01295749|Device|laryngeal tube ventilation and continuous chest compression|Comparison of no flow time between two strategies in out of hospital cardiac arrest
16212545|NCT01295736|Drug|Sildenafil|Sildenafil 20 mg TID per os during 90 days
16212546|NCT01295736|Drug|placebo|Placebo pills TID per os during 90 days
16212547|NCT01295723|Radiation|Hypofractionated Whole Breast Radiation Therapy|"Hypofractionated Whole Breast Radiation Therapy must start within 14-56 days postoperatively (week 2-8 post-op)
~Single reference dose per fraction: 2.7 Gy (ICRU)
~Number of fractions: 15
~Number of fractions per week: 5
~Regular Radiation Therapy breaks: Weekend/ Holidays (not exceeding 7 days break)
~Total dose: 50.5 Gy (40.5 WBRT + 10 Gy boost) Radiation: Intraoperative Electron Radiation Therapy"
16212548|NCT01295723|Radiation|Intraoperative Electron Radiation Therapy|Intraoperative Electron Radiation Therapy (IOERT) is delivered after completion of the lumpectomy and sentinel node procedure. IOERT is performed on mobile or fixed linac with variable electron energies in the range of 4-12 MeV
16212549|NCT01295710|Biological|US-ATG-F|20 mg/kg body weight per day, diluted in 250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
16212550|NCT01295710|Biological|Placebo|250 mL normal saline, IV infusion over 6-16 hours 3 days prior to transplantation
16212551|NCT01295697|Drug|EZN-2208|Experimental
16212552|NCT01295684|Other|Cranberry juice|base diet supplemented with two 8 ounce servings of low calorie cranberry juice per day
16212553|NCT01295684|Other|Placebo|base diet supplemented with two 8 ounce servings of a color and flavor matched placebo beverage
16212554|NCT01295671|Behavioral|Provision of beverages|Home delivery of specified beverage type
16212555|NCT01295645|Drug|Cidofovir|0.5 mg/kg by vein (IV) 3 times a week for 4 weeks.
16212556|NCT01295645|Other|No Cidofovir|Standard of Care: Pharmacologic management of pain, spasms, and urinary urgency with medications, hyper-hydration, or continuous bladder irrigation.
16212557|NCT01295632|Drug|ridaforolimus|10 mg enteric-coated tablets, orally, starting dose 2 tablets and escalating to 4 tablets each day for 5 days per week.
16212558|NCT01295632|Drug|MK-0752|300 mg capsule, orally, 6 capsules per dose, once each week.
16212559|NCT01295632|Drug|MK-2206|Tablets (5 mg, 25 mg, and 200 mg) to equal starting dose of 90 mg and escalating to 200 mg per dose, orally, once each week.
16212560|NCT01295619|Device|I-020805|A thin layer of I-020805 applied up to two times on the sutured dura mater
16212561|NCT01295606|Drug|Cefazolin|iv cefazolin (50mg/kg, 3 times a day) will be given as a routine prophylaxis treatment
16212779|NCT01293955|Drug|JOINS 200mg|1 tablet at each time, 3 times a day
16212562|NCT01295593|Drug|valproic acid and 2-chlorodeoxyadenosine|VPA : daily, oral, starting dose 10mg/kg/day total dose, taken in 2 separate administrations of around 5 mg/kg/day each, for a maximum of 6 months CdA : 5.6 mg/m²/day IV during 3 days, every 28 days, for a maximum of 4 cycles
16212563|NCT01295580|Device|ARTZ|Hyaluronic acid (five 2.5 mL injections)
16212564|NCT01295580|Device|DUROLANE|Hyaluronic acid stabilized (one 3.0 mL injection + four weekly 0 mL sham injections)
16212565|NCT01295567|Drug|Dipyridamole|prior to CABG surgery 3 day treatment with dipyridamole 200mg SR twice daily
16212566|NCT01295567|Drug|placebo|prior to CABG surgery 3 day treatment with placebo capsules twice daily
16212567|NCT01295554|Other|NCE MRA and CE MRA|"Each patient will receive on the same day:
~NCE MRA
~CE MRA usually performed in the clinical routine
~After each MRA examination, the CE images will be interpreted by a radiologist and the report transmitted to the prescriber within the usual delay. The radiologists in charge of this interpretation will not be involved in the evaluation of NCE images nor in the comparison between CE and NCE images."
16212568|NCT01295528|Device|Comparison test|Yuyue medical BP meter, accuracy: ±1mmHg and range: 0-300mmHg.
16212569|NCT01295515|Drug|Pegylated Interferon Alpha 2b (PEGINTRON)|pegylated preparation of interferon alpha 2b
16212570|NCT01295502|Drug|Carboplatin|Given IV
16212571|NCT01295502|Drug|Cisplatin|Given IV
16212572|NCT01295502|Radiation|External Beam Radiation Therapy|Undergo EBRT
16212573|NCT01295502|Radiation|Internal Radiation Therapy|Undergo brachytherapy
16212574|NCT01295502|Drug|Paclitaxel|Given IV
16212575|NCT01295489|Other|Laboratory Biomarker Analysis|Correlative studies
16212576|NCT01295476|Genetic|gene expression analysis|
16212577|NCT01295476|Genetic|microarray analysis|
16212578|NCT01295476|Other|laboratory biomarker analysis|
16212579|NCT01295463|Other|questionnaire administration|
16212580|NCT01295463|Other|study of socioeconomic and demographic variables|
16212581|NCT01295463|Procedure|assessment of therapy complications|
16212582|NCT01295463|Procedure|fertility assessment and management|
16212583|NCT01295463|Procedure|psychosocial assessment and care|
16212584|NCT01295463|Procedure|quality-of-life assessment|
16212585|NCT01295450|Drug|Apevinat BC|"Apevinat BC presents in its formula the cyproheptadine hydrochloride (0,800 mg), tiamin hydrochloride(0,120 mg), Riboflavin sodium phosphate (0,200 mg), nicotinamide (1,334 mg, piridoxin hydrochloride (0,134 mg), ascorbic acid (4,334 mg).
~Administer the recommended dosage for children 7 to 14, preferably one hour before meals: 5 ml three times daily."
16212586|NCT01295450|Drug|Vitamin Complex|A vitamin complex contains: B1, B2, B3, B3 and C vitamins. Administer the recommended dosage preferably one hour before meals: 5 ml three times daily.
16212587|NCT01295437|Device|Vypro II mesh|partly absorbable mesh
16212588|NCT01295437|Device|Premilene LP|lightweight mesh
16212589|NCT01295437|Device|Premilene mesh|A conventional polypropylene mesh (82 g/m2)
16212590|NCT01295424|Other|No intervention|Observational study, no interventions
16212591|NCT01295411|Device|Magnetic Resonance Imaging|
16212592|NCT01295411|Other|EVALUATION NEUROPSYCHOLOGICAL|
16212593|NCT01295398|Device|nebulisations|
16212594|NCT01295385|Other|NUCLEAR MAGNETIC RESONANCE IMAGING|"Techniques of nuclear magnetic resonance offer interesting perspectives in this context, and particularly to quantify the myocardial blood flow at rest and after cold pressor test in a population of healthy volunteers."
16212595|NCT01295385|Other|NUCLEAR MAGNETIC RESONANCE IMAGING|Techniques of nuclear magnetic resonance offer interesting perspectives in this context, and particularly to quantify the myocardial blood flow will be obtained by estimating myocardial blood flow at the venous coronary sinus site. This allows us to quantify a possible endothelial dysfunction in a reproducible way. No MRI study in diabetic patients has ever been led until now with this technique and to estimate the metabolic and structural abnormalities in this population.
16212596|NCT01295372|Drug|Zicronapine|7.5 mg/day; orally
16212597|NCT01295372|Drug|Risperidone|5 mg/day; orally
16212598|NCT01295359|Other|Ground Walking Program|The patients will walk on a corridor, for 40min, once a day. The speed will be controlled through a metronome, that will be programed to a frequency of steps/min determinated as 80% of the mean frequency of steps performed in six minutes walk test of that day. The 40min will be divided in 3min of walk and 2min of rest, totalizing 24min of exercise and 16min of rest. Furthermore, these patients, in sitting position, will receive orientation to do calm and slow inspirations and expirations, associated with pursed lips expiration. They will try to maintain its Respiratory Rate in 6bpm, during four minutes.
16212599|NCT01295346|Other|Head CT scan and blood draw|
16212600|NCT01295333|Drug|the early prophylactic introduction of low dose of LT4 (50 µg/d) at 15 days post-ablation|
16212601|NCT01295333|Drug|The initiation of LT4 as soon as the first biological signs of hypothyroidism.|
16212602|NCT01295320|Procedure|Blood sample|Blood sample will be collected at Month 48, Month 60 and Month 72
16212603|NCT01295307|Drug|Clofarabine|Induction and consolidation therapy / conditioning therapy with Clofarabine
16212604|NCT01295294|Drug|Tranexamic acid|500 mg 3 times daily per oral during bleeding/spotting episodes
16212605|NCT01295294|Drug|Mefenamic acid|500 mg 3 times daily per oral during bleeding/spotting episodes
16212606|NCT01295294|Drug|Placebo|3 times daily per oral during bleeding/spotting episodes
16212607|NCT01295294|Drug|Mirena (Levonorgestrel IUS, BAY86-5028)|In vitro release rate 20 microgram/24 hours. Intrauterine system
16212608|NCT01295281|Device|LoFric POBE 2.0|To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.
16212609|NCT01295281|Device|LoFric PVC|To be used at least twice daily, during 7 days. Treatment period 1 and 2 last 7 days, respectively.
16212610|NCT01295268|Other|Emu Oil|Subjects will apply a specified amount of emu oil daily to area.
16212611|NCT01295268|Other|Inert oil|A specified amount of inert oil will be applied daily to area.
16212677|NCT01294735|Drug|Temozolomide|MK-4827 in combination with temozolomide utilizing a number of doses and schedules for both drugs will be explored to determine a preliminary MTD. The preliminary MTD will then be confirmed in participants with melanoma and glioblastoma multiforme.
16212678|NCT01294709|Drug|telcagepant|
16212612|NCT01295229|Procedure|laparoscopic Roux-en-Y gastric bypass (RYGB) procedure|The laparoscopic Roux-en-Y gastric bypass (RYGB) procedure is the most commonly performed bariatric procedure in the United States. Patients randomized to the surgical arm will undergo a standard laparoscopic proximal RYGB, as commonly practiced by GH surgeons, using a 90-cm alimentary limb, 50-cm biliopancreatic limb, antecolic/antegastric approach, and totally stapled technique.
16212613|NCT01295229|Behavioral|Lifestyle Intervention|The lifestyle intervention includes behavior-modification skills counseling combined with training in diet and exercise change. The focus of the exercise intervention is a gradual increase in brisk walking or other activities of similar moderate aerobic intensity. The exercise prescription will consist of at least 45 minutes of exercise, 5 days per week for 12 months. The diet intervention will be conducted by a research dietician with training in behavior modification, with supervision by Dr. Foster-Schubert. In week 1 the dietician will meet for a 60-minute individual session with participants at the FHCRC Prevention Center. Over the next 23 weeks the dietician will conduct one 30-minute group session per week.
16212614|NCT01295216|Behavioral|Mobile technology to promote lifestyle modification|Effects of an intervention using mobile health (mHealth) technology, including short message services (SMS) and one-to-one telephone calls, to promote lifestyle modification focused on reducing blood pressure among participants
16212615|NCT01295203|Behavioral|website assess|The internet intervention group were given assess to the intervention website which included a personal page with tailored physical activity advice and a personal profile together with Recommendations and general training programs.
16212616|NCT01295177|Drug|topic cream insulin|Intervention: Placebo cream versus insulin cream. Patients with wounds for more than 3 months without infection. These patients were treated with placebo cream or insulin cream. The placebo or insulin were used for 8 weeks.
16212617|NCT01295164|Device|classic aberrometer and aberrometer AOVIS-1|"Measurement of aberrations in early stages (1 and 2) of keratoconus as compared aberrometer AOVIS-1 with a classic aberrometer."
16212618|NCT01295164|Device|Aberrometer AOVIS-I|Measurement of aberrations in high stages (3 and 4) of keratoconus. Objective characterization of the optical quality of the patient eye by application of wave-front sensing technology in late stage keratoconus The complete procedure in one patient takes less than 5 minutes in only one consultation and is completely non invasive. The optical measurements only involve the use of low power infrared laser
16212619|NCT01295151|Drug|Etanercept|"Etanercept will be administered at a dose of 50mg by subcutaneous injection per week for a total of 12 weeks. Further treatment will be prescribed at the discretion of the treating clinician.
~The patient will be taught how to administer the subcutaneous injection and injections will be monitored by the hospital until the patient is proficient with the technique."
16212620|NCT01295151|Drug|Abatacept|"Abatacept will be administered at a dose determined by body weight:
~Body Weight (kg) Dose (mg) < 60kg = 500 mg
~> or equal to 60kg and < or equal to 100kg = 750 mg > 100 kg = 1000mg
~The intravenous infusions will be administered in clinic on days 1, 15, 29 and every 28 days thereafter for a minimum of 24 weeks. Further treatment will be prescribed at the discretion of the treating clinician."
16212621|NCT01295151|Biological|Rituximab|"Rituximab will be given at a dose of 1000mg; 2 intravenous infusions will be administered at days 0 (week 0) and 15 (week 2).
~In line with standard practice, a patient who loses an initial response with a DAS28 increase of at least 0.6 may receive a further cycle of rituximab at the discretion of the treating clinician.
~Prior to receiving rituximab, intravenous methylprednisolone 100mg will also be given."
16212622|NCT01295151|Drug|Adalimumab|"Adalimumab will be given at a dose of 40mg by subcutaneous injection every two weeks for a minimum of 12 weeks. Further treatment will be prescribed at the discretion of the treating clinician.
~The patient will be taught how to administer the subcutaneous injection and injections will be monitored by the hospital until the patient is proficient with the technique."
16212623|NCT01295151|Drug|Certolizumab Pegol|"Certolizumab Pegol will be given at a dose of 400mg by subcutaneous injection at weeks 0, 2, 4and then at a dose of 200mg every two weeks thereafter for a minimum of 12 weeks. Further treatment will be prescribed at the discretion of the treating clinician.
~The patient will be taught how to administer the subcutaneous injection and injections will be monitored by the hospital until the patient is proficient with the technique."
16212624|NCT01295151|Drug|Infliximab|"Infliximab will be given at a dose of 3mg/kg per intravenous infusion in clinic.
~The intravenous infusions will be administered at week 0, 2, 6 and then 8-weekly thereafter for a minimum of 12 weeks.
~Further treatment will be prescribed at the discretion of the treating clinician."
16212625|NCT01295151|Drug|Golimumab|"Golimumab will be given at a dose of 50mg by subcutaneous injection every 4 weeks for a minimum of 24 weeks.
~Further treatment will be prescribed in line with the study protocol and following week 48, at the discretion of the treating clinician.
~The participant will be taught how to administer the subcutaneous injection and injections will be monitored according to local arrangements until the participant is proficient with the technique according to local practice."
16212626|NCT01295138|Drug|Lactulose|Lactulose liquid. 15mls twice daily
16212627|NCT01295125|Device|XenMATRIX mesh|Use of XenMATRIX mesh in the repair of contaminated ventral hernia repair
16212628|NCT01295125|Procedure|Open abdominal ventral hernia repair|Abdominal ventral hernia repair with native tissue
16212629|NCT01295112|Drug|Active bevacizumab and Sham dexamethasone|Bevacizumab: 25 mg/mL, PRN dosing Sham dexamethasone intravitreal implant: blunt needling of the sclera with no penetration of the globe
16212630|NCT01295112|Drug|Active bevacizumab and Active dexamethasone|Bevacizumab: 25 mg/mL, PRN dosing Dexamethasone intravitreal implant: 0.7 mg, single dose
16212631|NCT01295099|Drug|5- fluorouracil|5mg of 5FU injected per 1cm square, at 6 week intervals for 30 weeks = 6 sessions
16212632|NCT01295099|Radiation|radiotherapy|after complete excision of keloid they have a single session of radiotherapy
16212633|NCT01295099|Drug|Triamcinolone|TAC 10mg in 1ml injected intralesional
16212634|NCT01295086|Drug|Docetaxel|42, 51 or 60 mg/m² day 1 every 3. week
16212635|NCT01295086|Drug|Oxaliplatin|100 mg/m² day 1 every 3. week
16212636|NCT01295086|Drug|Capecitabine|1250 mg/² continuously
16212637|NCT01295086|Drug|Trastuzumab|Trastuzumab 8 mg/kg day 1, cycle 1. Following cycles 6 mg/kg every 3. week
16212679|NCT01294709|Drug|Placebo to telcagepant|
16212729|NCT01294384|Drug|carboxymethylcellulose sodium based New Eye Drop Formulation 2|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 2 in each eye at least twice daily for 90 days.
16212638|NCT01295073|Drug|Trientine Hydrochloride|"Arm A's therapeutic intervention is the use of Trientine Hydrochloride for 10 days in the perioperative period.
~All participating subjects will all receive cataract surgery according to present standards of care; however, subjects randomized the intervention group (trientine hydrochloride) will be on a 10 day course of oral Trientine at 1500mg administered for 7 days prior to and 3 days after surgery."
16212639|NCT01295073|Other|For Arm B there is no therapeutic intervention other than standard of care, which is cataract surgery.|see above
16212640|NCT01295060|Drug|Octreotide|84 mg Octreotide Implant
16212641|NCT01295047|Drug|Atenolol|
16212642|NCT01295047|Drug|VERAPAMIL|240 MG SR
16212643|NCT01295047|Drug|Perindopril|4 MG
16212644|NCT01295034|Dietary Supplement|conventional vitamin D treatment|Subjects in Protocol A (the conventional/active placebo arm) will receive 50,000 IU/wk of vitamin D2 for 8 wk followed by 1000 IU/d of vitamin D3 for 48 wk.
16212645|NCT01295034|Drug|tiered/titrated vitamin D dosing|Subjects in Protocol B will receive 2000-4000 IU/d of vitamin D3, depending on the basal 25(OH)D level, with dose titration, as necessary, based on the slope of the initial response, for a total duration of treatment of 12 mo.
16212646|NCT01294995|Dietary Supplement|Tea-flavor Liquor|30 mL of Tea-flavor Liquor(45% alcohol content)
16212647|NCT01294995|Dietary Supplement|Guizhou Meijiao Liquor|30 mL of Guizhou Meijiao Liquor (45% alcohol content)
16212648|NCT01294982|Drug|AOBO-001|AOBO-001 400 mg Oral Capsules (1.6 g dose) twice daily
16212649|NCT01294982|Drug|AOBO-001|AOBO-001 400 mg Oral Capsules (3.2 g dose) twice daily
16212650|NCT01294982|Drug|Placebo|Placebo Oral Capsules twice daily
16212651|NCT01294969|Drug|AL-4943A|Once daily topical ocular allergy medication used for 7 days
16212652|NCT01294956|Other|Lubricant Eye Drop|1 drop in each eye, four times a day for 42 days
16212653|NCT01294956|Other|Refresh Liquigel|1 drop in each eye, four times a day for 42 days
16212654|NCT01294943|Device|Tongue cleaner|Use of the tongue cleaner (TePe ®) to remove the tongue biofilm in patients on mechanical ventilation.
16212655|NCT01294930|Other|Urine density|measurement of urine color, density and plethysmographic variability index before and during surgery.
16212656|NCT01294917|Device|Multi-purpose disinfecting solution|For the cleaning, rinsing, and storage of soft contact lenses.
16212657|NCT01294917|Device|Clear Care|Peroxide-based regimen for cleaning and disinfecting soft contact lenses.
16212658|NCT01294917|Device|Opti-Free RepleniSH|Multi-purpose disinfecting solution for the cleaning, rinsing and storing of soft contact lenses.
16212659|NCT01294891|Other|Imaging|Contrast ultrasound perfusion imaging and complete echocardiography
16212660|NCT01294878|Drug|omalizumab|The omalizumab dose has been calculated on the basis of body weight and basal levels of total serum IgE. Treatment was administered subcutaneously every 2 or 4 weeks (according to the calculated total dose) for a total of 48 weeks. Each vial contained 150 mg of the active compound, therefore the number of injections for each administration varied between 1 and 3, depending on the total dose used.
16212661|NCT01294852|Other|surfactant prophylaxis|Premature infants born before 28 weeks' gestation and infants born at 29 to 30 weeks' gestation who did not receive antenatal steroid were randomized before delivery to receive either immediate bolus or post-resuscitation surfactant prophylaxis at 15 minutes after birth. Those infants who were randomized to immediate bolus surfactant were intubated as rapidly as possible after birth, were administered 100 mg/kg surfactant (Curosurf[Chiesi, Farmaceutici, Parma, Italy]), and received standard resuscitation measures as indicated. Those infants who were randomized to post-resuscitation surfactant received standard resuscitation measures first, were intubated electively at 15 minutes after birth and received 100 mg/kg surfactant (Curosurf[Chiesi, Farmaceutici, Parma, Italy]).
16212662|NCT01294839|Device|Right ventricular lead location|RV leads in RVOTs group will be located in right ventricular outflow tract septum, RV leads in the other two group will be implanted in right ventricular apex, for the last RVOTs and RVA groups, the accumulated ventricular pacrouping percentage should be over 80% by adjusting AV delays.
16212663|NCT01294826|Drug|AUY922|Weekly intravenous infusion on Day 1, 8, 15 and 22 of each 28 day cycle until unacceptable toxicity develops or disease progression. A minimum of 3 patients will be enrolled into each cohort. The anticipated dose escalation sequence of AUY922 is 40, 55, and 70 mg/m2 will be used.
16212664|NCT01294826|Drug|Cetuximab|Cetuximab will be administered after each AUY922 infusion, intravenously on Day 1, 8, 15 and 22 of each 28 day cycle until unacceptable toxicity develops or disease progression.
16212665|NCT01294813|Device|Electrical Impedance Tomography (EIT)|EIT measurements of 1-2 minutes are performed in patients who routinely undergo bronchoscopy (during 1.5 hours) before, directly after and 10, 30, 60 minutes after bronchoscopy. Therefore the rubber belt including 16 integrated electrographic electrodes is placed around the patient´s chest and connected with an EIT device. EIT data are generated by application of a small alternating current of 5mA and 50kHz and are stored and analyzed offline on a personal computer. Pseudonomyzed EIT data are evaluated descriptively.
16212666|NCT01294800|Drug|Preladenant|2, 5, or 10 mg tablets taken orally twice daily (BID)
16212667|NCT01294800|Drug|Placebo tablet to match Preladenant|tablets taken orally BID
16212668|NCT01294787|Drug|indacaterol and glycopyrronium bromide (QVA149)|
16212669|NCT01294787|Drug|placebo|
16212670|NCT01294787|Drug|tiotropium|
16212671|NCT01294774|Drug|KRP203 - 1.2mg|
16212672|NCT01294774|Drug|Placebo to KRP203 - 1.2 mg|
16212673|NCT01294761|Drug|Raltegravir, Darunavir/r|"An arm to change the regimen to: raltegravir and darunavir/ritonavir
~Prezista naive 2 tabs PC QD, Norvir soft-capsule 1 cap PC QD and Isentress 1 tab BID or Prezista 2 tabs PC BID and Norvir soft-capsule 1 cap PC BID, and Isentress 1 tab BID
~from: Kaletra 4 tabs QD and Truvada 1 tab QD or Kaletra 4 tabs QD, Viread 1 tab QD, Epivir300mg 1 tab (or Epivir 150mg 2 tabs) QD"
16212674|NCT01294748|Device|MiStent DES|The MiStent is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
16212675|NCT01294748|Device|Endeavor DES|The Endeavor is a device/drug combination comprised of two components; a stent and a drug product (everolimus within a durable polymer coating).
16212676|NCT01294735|Drug|MK-4827|MK-4827 in combination with temozolomide utilizing a number of doses and schedules for both drugs will be explored to determine a preliminary MTD. The preliminary MTD will then be confirmed in participants with melanoma and glioblastoma multiforme.
16212685|NCT01294670|Drug|Vorinostat and Etoposide|Patients will be assessed in 3-week cycles. Escalating doses of vorinostat will be administered orally on a daily x 4 schedule in combination with a fixed dose of etoposide. Etoposide will be administered intravenously daily x 3 days. Cohorts of 3-6 patients will be treated with vorinostat and etoposide. In the phase II component, patients will be treated at the RP2D established in the Phase I component of the study, which was found to be 270 mg/m2/dose of Vorinostat and 100 mg/m2/dose of Etoposide.
16212686|NCT01294657|Behavioral|Health Education|Counseling, referrals to available resources and self-help materials on Day 1, at 6 and 12 month visits, along with surveys at 6 and 12 months.
16212687|NCT01294657|Behavioral|MAPS|12 counseling phone calls over 1 year, lasting about 20-30 minutes.
16212688|NCT01294644|Drug|Deoxycholic acid injection|
16212689|NCT01294644|Drug|Placebo|Phosphate buffered saline placebo for injection
16212690|NCT01294631|Drug|Canagliflozin 300 mg once daily and HCTZ 25 mg once daily|"Period 1: canagliflozin tablets, oral, 300 mg, once daily on Days 1 to 7 followed 14 days later by Period 2.
~Period 2: HCTZ tablets, oral, 25 mg, once daily for Days 1 to 28 followed by canagliflozin tablets, oral, 300 mg, once daily taken with HCTZ tablets, oral 25 mg, once daily on Days 29 to 35.."
16212691|NCT01294618|Drug|Nilotinib,Novartis,300 mg twice a day +Pegylated interferon 2a,Roche, 45 microg weekly starting Month 2-Month 12 or beyond according to investigator choice.|Combination of both treatments active by different means on the leukemic cells, in order to enhance the response rates of CP CML patients since diagnosis.
16212692|NCT01294605|Biological|Boostrix™ (dTpa)|Intramuscular, 3 doses
16212693|NCT01294605|Biological|GSK Biologicals' reduced-antigen-content combined diphtheria, tetanus, acellular pertussis and inactivated polio vaccine (dTpa-IPV; BoostrixTM)|Intramuscular, single dose
16212694|NCT01294605|Biological|Ditanrix™ Adult, TedivaxTM (Td)|Intramuscular, 2 doses
16212695|NCT01294605|Biological|Ditanrix™ Adult, TedivaxTM (Td)|Intramuscular, 3 doses
16212696|NCT01294592|Drug|Dutasteride plus tamsulosin|Take 1 capsule daily
16212697|NCT01294592|Drug|tamsulosin|Take 1 capsule daily when escalation criteria met
16212698|NCT01294579|Biological|Ofatumumab|"1000 mg intravenous (IV) on day 1 of each cycle (cycles 1-6) for induction phase
~1000 mg IV every 2 months for 2 years"
16212699|NCT01294579|Drug|Bendamustine|90 mg/m2 on day 1 (after the ofatumumab infusion) and day 2 of each cycle (cycles 1-6)
16212700|NCT01294566|Drug|GSK1322888|1 mg, 5 mg or 25 mg capsule
16212701|NCT01294566|Drug|Placebo|matching placebo capsules
16212702|NCT01294553|Drug|Administration of rosiglitazone/metformin|Subjects who are administered rosiglitazone/metformin at least once
16212703|NCT01294540|Drug|Drug: E2609|E2609 orally at varying ascending doses
16212704|NCT01294540|Drug|Placebo|Matching Placebo
16212705|NCT01294527|Device|Wireless cardiac stimulator implant to pace the left ventricle for CRT|Transvascular endocardial implantation of wireless pacing Electrode and subcutaneous implantation of Implantable Pulse Generator
16212706|NCT01294501|Other|Medication administration educational module|The Research Assistant (RA) will enter the subject's language (English or Spanish), the type of medicine (tablet/capsule, liquid, or ointment) from the antibiotic prescription, and the frequency (once a day, twice a day, three times a day, four times a day) from the antibiotic prescription into the web-based educational module on medication administration so that a tailored module will be setup for the subject. The subject will then view the educational interactive module. After the subject is done with the module, the RA will administer a verbal post-test. The post-test will include questions on medication administration as well as questions on fever assessment and management.
16212707|NCT01294488|Behavioral|Parent-Child Interaction Therapy|Therapists receive training in Parent-Child Interaction Therapy (PCIT) and receive supervision in their implementation of PCIT skills via phone consultation and polycommunication technology, each for 6 months.
16212708|NCT01294475|Behavioral|Planned Activities Training|Mothers will be provided a parenting intervention, Planned Activities Training (PAT). Some of the mothers will receive the PAT intervention enhanced with a cell phone.
16212709|NCT01294462|Drug|Ticagrelor|90 mg, oral dose twice daily
16212710|NCT01294462|Drug|Clopidogrel|75 mg, oral dose once daily
16212711|NCT01294462|Drug|Acetylsalicylic acid ASA|Low Dose ASA
16212712|NCT01294449|Device|MADIT-CRT ICD|Patients that were randomized to the the implantable cardioverter defibrillator (ICD) device for the study.
16212713|NCT01294449|Device|MADIT-CRT CRT-D|Patients that were randomized to the the cardiac resynchronization therapy with defibrillation (CRT-D) device for the study.
16212714|NCT01294436|Drug|Dapagliflozin|Oral Dose 5 or 10 mg
16212715|NCT01294423|Drug|Dapagliflozin|Dapagliflozin 5mg/matching placebo for Dapagliflozin 10mg oral dose
16212716|NCT01294423|Drug|Dapagliflozin|Dapagliflozin 10mg/matching placebo for Dapagliflozin 5mg oral dose
16212717|NCT01294423|Drug|Placebo|Matching placebo for Dapagliflozin 5mg/10mg oral dose
16212718|NCT01294410|Drug|Placebo|Normal Saline, Intravenous, 0mg, Once a week for the first two weeks and every other week thereafter, 7 Weeks
16212719|NCT01294410|Drug|Placebo|Normal Saline, Intravenous, 0 mg, Every other week, Up to 757 days
16212720|NCT01294410|Drug|Anti-IP-10 Antibody|Solution for IV administration, Intravenous, 15 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
16212721|NCT01294410|Drug|Anti-IP-10 Antibody|Solution for IV administration, Intravenous, 25 mg/kg, Once a week for the first two weeks and every other week thereafter, 7 weeks
16212722|NCT01294410|Drug|Anti-IP-10 Antibody|Solution for IV administration, Intravenous, 5 mg/kg, Every other week, Up to 757 days
16212723|NCT01294410|Drug|Anti-IP-10 Antibody|Intravenous, Solution for IV administration, 10 mg/kg, Every other week, Up to 757 days
16212724|NCT01294410|Drug|Anti-IP-10 Antibody|Intravenous, Solution for IV administration, 20 mg/kg, Every other week, Up to 757 days
16212725|NCT01294410|Drug|Anti-IP-10 Antibody|Intravenous, Solution for IV administration, 15 mg/kg or optimal dose, Every other week. Open
16212726|NCT01294397|Drug|Etanercept|Administered by subcutaneous injection once a week
16212727|NCT01294397|Drug|Denosumab|Administered by subcutaneous injection
16212728|NCT01294384|Drug|carboxymethylcellulose sodium based New Eye Drop Formulation 1|1 to 2 drops of carboxymethylcellulose sodium based New Eye Drop Formulation 1 in each eye at least twice daily for 90 days.
16212731|NCT01294358|Drug|Gemcitabine|Gemcitabine starting dose was 18mg/m(2)/24h via infusion pump on days 1-14. One cycle = 4 weeks for up to six cycles. Three to six patients enrolled per dose cohort. Patients were dosed at successive higher doses until maximum tolerated dose or up to 165 mg/m(2)/24h.
16212732|NCT01294332|Other|Aerobic Exercise Training|supervised exercise on the treadmill at target heart rate range for 12 weeks, 3 times a week for 30 minutes.
16212733|NCT01294319|Drug|Mifepristone|
16212734|NCT01294319|Drug|Placebo|
16212735|NCT01294319|Drug|Spironolactone|
16212736|NCT01294319|Drug|Combined|
16212737|NCT01294319|Drug|Dexamethasone|
16212738|NCT01294306|Drug|Akt Inhibitor MK2206|Given PO
16212739|NCT01294306|Drug|Erlotinib Hydrochloride|Given PO
16212740|NCT01294306|Other|Laboratory Biomarker Analysis|Correlative studies
16212741|NCT01294306|Other|Pharmacological Study|Correlative studies
16212742|NCT01294293|Drug|TLR8 Agonist VTX-2337|Given SC
16212743|NCT01294293|Other|Diagnostic Laboratory Biomarker Analysis|Correlative studies
16212744|NCT01294293|Other|Pharmacological Study|Correlative studies
16212745|NCT01294293|Drug|Pegylated Liposomal Doxorubicin Hydrochloride|Given IV
16212746|NCT01294293|Drug|Paclitaxel|Given IV
16212747|NCT01294280|Other|Laboratory Biomarker Analysis|Correlative studies
16212748|NCT01294267|Device|Circulatory Support System|Femoral angiography will be performed, and if the anatomy is suitable, the femoral artery preclosure technique will be employed. The Impella 2.5 will be inserted through th femoral artery into the left ventricle. Anti-coagulation will be titrated to achieve a therapeutic ACT level. Organ perfusion and Hemodynamic data will be collected during simulated VTs and throughout the course of the case. The performance level of the device may be adjusted during the case to quantify hemodynamic effects
16212749|NCT01294254|Drug|Oleogel-S10|Oleogel-S10 on one half of the skin graft donor site (each time when the wound dressing is changed during a time period of 14 days, normally once daily)
16212750|NCT01294254|Procedure|Moist wound healing dressings alone (Mepilex) on the other half of the skin graft donor site|wound is covered conventionally by applying one half of the Mepilex cut
16212751|NCT01294241|Drug|Oleogel-S10|1 cm or 125 µL or 115 mg Oleogel-S10 per cm2 wound area (corresponds to thickness of approximately 1 mm or 0.04 inch) every 24 to 48 hours until discharge from hospital or until the end of treatment at Day 14 in 'recent wounds' or Day 28 in 'chronic wounds'.
16212752|NCT01294241|Device|Mepilex® soft silicone faced polyurethane foam dressing|Mepilex® soft silicone faced polyurethane foam dressing was changed about every 24 to 48 hours until discharge from hospital or until the end of treatment at Day 14 in 'recent wounds' or Day 28 in 'chronic wounds'.
16212753|NCT01294215|Drug|Nifedipine (Adalat, BAYA1040)|Nifedipine (Adalat, BAYA1040) 40mg twice a day (BID)
16212754|NCT01294202|Drug|AT13387 and Imatinib|"In part 1 pts will receive AT13387 in combination with imatinib. Up to 5 possible dose levels of AT13387 could be evaluated in combination with imatinib 400 mg daily: 120 mg/m2, 150 mg/m2, 180 mg/m2, 220 mg/m2 and 260 mg/m2. AT13387 IV (in the vein) on day 1, 8 and 15 of each 28 day cycle, until progression or unacceptable toxicity develops, in order to establish the recommended phase II combination dose, which will be used in part 2 and/or part 3 of the study.
~In part 2 an additional 6-9pts will be treated.
~In part 3, provided that sufficient evidence of anti-tumour effect was observed in part 2 (disease stabilisation or reduction in tumour dimensions by RECIST), then an additional 12pts will be treated with AT13387 in combination with imatinib. Alternatively, if combination treatment is found to have excellent efficacy the randomised phase of the study may start so that 12 pts receive AT13387 on its own (monotherapy) and 12 pts receive AT13387 in combination with imatinib."
16212755|NCT01294176|Drug|Lipoic Acid|Lipoic acid will be administered orally, in two 600mg capsules, for a total 1200mg dose. The dose will be administered daily for a 6-week treatment period.
16212756|NCT01294163|Drug|Xenon|Inhaled xenon, maximal inspired concentration of 65%.
16212757|NCT01294163|Drug|Sevoflurane|Inhaled sevoflurane, maximal inspired concentration of 1.8%.
16212758|NCT01294163|Drug|Propofol|Hourly dose of 2-4 mg/kg
16212759|NCT01294150|Device|UroLift System|The NeoTract UroLift System is a medical device approved for sale in the United States, European Union, and several other countries (see www.urolift.com). It was developed for the treatment of lower urinary tract symptoms (LUTS) associated with Benign Prostatic Hyperplasia (BPH). During the procedure, an implant is delivered into the prostatic lobe obstructing the urethra and restricting urine flow. The distal end of the device is used to compress the lobe then the implant is delivered to retain the lobe in position, thereby increasing the urethral opening and reducing the fluid obstruction through the prostatic urethra.
16212760|NCT01294150|Other|Cystoscopy|The Control Group will undergo cystoscopy.
16212761|NCT01294150|Device|Crossover|Subjects crossed over and received the UroLift System from the Control Group.
16212762|NCT01294137|Device|ventilatory polygraphy|
16212763|NCT01294111|Behavioral|Tai Chi training|Three groups with 15 participants each will complete a 60 minutes tai chi training programme twice-weekly for 16 weeks. The programme is worked out by an expert in Chinese traditional medicine to suit elderly people with chronic heart failure, and the classes are led by experienced leaders.
16212764|NCT01294098|Drug|Marcaine|0.75 cc/kg of 1/4% Marcaine
16212765|NCT01294072|Dietary Supplement|curcumin|tablets-3.6 gram (gm) taken daily for 7 days - 15 subjects
16212766|NCT01294072|Dietary Supplement|Curcumin conjugated with plant exosomes|tablets-taken daily for 7 days - 15 subjects
16212767|NCT01294072|Other|No intervention|no treatment
16212768|NCT01294059|Drug|Milnacipran|50 mg BID Oral x 6 Weeks
16212769|NCT01294046|Device|Deep Brain Stimulation of SPG for Migraine|Deep Brain Stimulation of SPG for Migraine
16212770|NCT01294033|Other|Fractional inspired oxygen (FiO2) 0.21|
16212771|NCT01294033|Other|Fractional inspired oxygen 0.28|Supplemental oxygen
16212772|NCT01294020|Drug|Tacrolimus|Oral capsule
16212773|NCT01294020|Drug|Tacrolimus prolonged release|Oral capsule
16212774|NCT01294007|Biological|PureGen Osteoprogenitor Cell Allograft|PureGen Osteoprogenitor Cell Allograft with posterior transpedicular fixation.
16212775|NCT01294007|Procedure|Autograft bone|Iliac Crest and Local Autograft Bone
16212776|NCT01293981|Biological|PureGen Osteoprogenitor Cell Allograft|PureGen Osteoprogenitor Cell Allograft.
16212781|NCT01293942|Drug|irinotecan, capecitabine, oxaliplatin (IXO) and bevacizumab|IXO plus bevacizumab regimen is given every 3 weeks (Q3W), in the following order: Bevacizumab (A): 7.5 mg/kg via IV infusion, day 1 Oxaliplatin (O): 100 mg/m2 via 2-hour IV infusion, day 1 Irinotecan (I): 160 mg/m2 via 1-hour IV infusion, day 1 Capecitabine (X): 950 mg/m2 twice daily PO, days 2 - 15
16212782|NCT01293916|Other|Spica casting|single versus double leg spica casting
16212783|NCT01293903|Drug|Qiliqiangxin capsule|Qiliqiangxin capsule is administrated based on the standard heart failure treatment in China. Dosage: 1.2g/times. Frequency: 3 times/day. Duration: The whole study period.
16212784|NCT01293903|Drug|Placebo|Placebo, similar in color and taste to Qiliqiangxin capsule, is administrated based on the standard heart failure treatment in China. Dosage: 1.2g/times. Frequency: 3 times/day. Duration: The whole study period.
16212785|NCT01293877|Procedure|Laparoscopy surgery for morbid obesity|The intervention will compare the 2 restrictive procedures one sleeve gastrectomy and gastric plication/
16212786|NCT01293838|Drug|Cipralex®|"Based on a starting rate of 5 mg/day, increased by 5 mg every 2 weeks to a maximum of 20 mg/day for weeks 7-16, each participant will receive up to:
~10 mg tablets: 28
~20 mg tablets: 84
~Total for 30 participants:
~10 mg tablets: 840
~20 mg tablets: 2520
~Continuation study for participants who respond to Cipralex - Across 12 weeks, each participant will receive up to:
~*20 mg tablets: 84
~Total for continuation study for all participants (assuming a 60% response rate, N=18):
~*20 mg tablets: 1512"
16212787|NCT01293825|Drug|ziprasidone|"Patients will identify which psychotropic they currently receive that causes the most weight-gain concern. For individuals on multiple drugs, one drug must be identified as the offending agent. Study psychiatrist will switch the offending agent to ziprasidone. Participants will be switched to ziprasidone per package insert. Patients will be maintained on ziprasidone for 12 weeks (active part of study). After the active part of the study they will return to the care of their normal clinical provider who will determine whether they will continue on ziprasidone."
16212788|NCT01293812|Drug|88% sucrose po solution|"88% sucrose solution (Syrup B.P.) The pharmacy will provide 2 syringes labeled sucrose study calculated to provide a 2 ml dose of a 88% sucrose solution or a color, consistency- and odor-matched placebo in identical packagings (2 syringes per patient in the case the dose needs to be repeated)."
16212789|NCT01293812|Drug|placebo po|"The pharmacy will provide 2 syringes labeled sucrose study calculated to provide a 2 ml dose of a solution or a color, consistency- and odor-matched placebo to the sucrose solution in identical packagings (2 syringes per patient in the case the dose needs to be repeated)."
16212790|NCT01293799|Behavioral|Follow-up of PD patients´ theoretical and practical skills|Testing of patients knowledge and retraining if needed
16212791|NCT01293773|Device|Taxus Element stent|paclitaxel-eluting stent
16212792|NCT01293773|Device|Integrity Resolute stent|ABT 578-eluting stent
16212793|NCT01293773|Device|Xience Prime stent|Everolimus-eluting stent
16212794|NCT01293760|Other|Immediate insertion|Insertion of Copper T 380A immediately after c-section delivery of baby and placenta
16212795|NCT01293760|Other|6 weeks interval insertion|Insertion of Copper T 380A 6 weeks after c-section delivery of baby and placenta
16212796|NCT01293747|Drug|Estradiol + Progesterone|Estradiol 1 mg and progesterone 20 mg microspheres injectable aqueous suspension, intramuscular monthly injection for a total of 4 doses.
16212797|NCT01293747|Drug|Estradiol + Progesterone|Estradiol 0.5 mg and progesterone 15 mg microspheres injectable aqueous suspension, intramuscular monthly injection for a total of 4 doses.
16212798|NCT01293734|Other|warming lung and relieving asthmatic granule and Securing origin and warming lung emplastrum|warming lung and relieving asthmatic granule:once 1 bag, 3 times a day. Securing origin and warming lung emplastrum: paste on acupuncture point and take the emplastrum down after 3 hours, once a day
16212799|NCT01293734|Other|clearing lung and relieving asthmatic granule and securing origin and clearing lung emplastrum|clearing lung and relieving asthmatic granule: once 1 bag, 3 times a day. securing origin and clearing lung emplastrum: paste on acupuncture point and take the emplastrum down after 3 hours, once a day
16212800|NCT01293734|Other|securing origin and relieving asthmatic granule and securing origin and nourishing lung emplastrum|securing origin and relieving asthmatic granule: once 1 bag, 3 times a day. securing origin and nourishing lung emplastrum: paste on acupuncture point and take the emplastrum down after 3 hours, once a day
16212801|NCT01293734|Drug|Theophylline Sustained-release Tablets and budesonide suspension|Theophylline Sustained-release Tablets 0.2g a time, twice a day. budesonide suspension for inhalation 100ug, twice a day
16212802|NCT01293721|Device|Low-magnitude high - frequency vibration treatment|stand on a vibration platform at 35Hz, 0.3g, 20mins/day and 7 days/week
16212803|NCT01293695|Behavioral|Hypnosis|Hypnosis relaxation in five weekly sessions
16212804|NCT01293695|Other|Structured attention|Meets with therapist for five weekly sessions and receives structured attention/supportive counseling, but receives no hypnotic relaxation therapy
16212805|NCT01293682|Drug|Calcitriol|In pill form, 45 micrograms once a week for 12 weeks
16212806|NCT01293669|Drug|TC-6987|TC-6987-23 (TC-6987 HCl) as experimental treatment: 20 mg loading dose (2 capsules) on Day 1 and 10 mg (1 capsule) on Days 2 to 28 (dose expressed as free base). Each dose will be given once daily.
16212807|NCT01293669|Drug|Placebo|Matching placebo: Mode of administration: p.o. (microcrystalline cellulose in capsule) given once daily.
16212808|NCT01293656|Other|No intervention.|There is no study intervention. Participants will be treated locally per site standards.
16212809|NCT01293643|Drug|100 mg clindamycin /800 mg ketoconazole vaginal ovule|1 vaginal ovule for 3 consecutive days
16212810|NCT01293643|Drug|100 mg tetracycline hydrochloride /50 mg amphotericin B cream|1 applicator (4 g) full of cream intravaginally for 7 to 10 days
16212811|NCT01293630|Drug|Ombrabulin (AVE8062)|"Pharmaceutical form:solution
~Route of administration: intravenous"
16212812|NCT01293630|Drug|Paclitaxel|"Pharmaceutical form:solution
~Route of administration: intravenous"
16212813|NCT01293630|Drug|Carboplatin|"Pharmaceutical form:solution
~Route of administration: intravenous"
16212814|NCT01293617|Other|Blackberries|300 g blackberries daily for 5 days
16212815|NCT01293617|Other|Gelatin|300 g gelatin per day for 5 days
16212854|NCT01293162|Drug|Armolipid Prev|Ortosiphon 300 mg/die, CoQ10 15 mg/die, Berberine 500 mg/die, red yeast 60 mg/die, policosanol 10 mg/die, Folic acid 200 mg/die
16212816|NCT01293604|Other|Daily ingestion of whole grain barley and oats|Subjects will be randomly assigned to one of three treatments: 1) a control diet containing 0.7 daily servings of whole grain, 2) a diet containing at least 4 daily servings of whole grain barley or 3) a diet containing at least 4 servings of whole grain oats. After 6 weeks, risk factors of cardiovascular disease will be assessed after a 12 hr fast. During the seventh week, risk factors of cardiovascular disease will be assessed in the postprandial state.
16212817|NCT01293591|Other|Control|Subjects will consume a garlic-free diet for 10 days. On day 11, subjects will consume 270 kcal white bread with 15 g margarine.
16212818|NCT01293591|Other|Garlic treatment|Subjects will consume a garlic-free diet for 10 days. On day 11, subjects will consume 270 kcal white bread with 15 g margarine and 5 g crushed garlic.
16212819|NCT01293578|Other|Diabetes Medication Choice Cards|Clinician uses the Diabetes Medication Choice Cards to inform and engage patient in discussing the issues they find relevant in choosing a new diabetes medication.
16212820|NCT01293552|Biological|ANT-1207|single dose application
16212821|NCT01293552|Biological|Vehicle|
16212822|NCT01293539|Drug|Melphalan hydrochloride|"Drug administered intra-arterially (injection in the artery).
~Standard dose:
~2.5mg (3-6 month old) 3.0 mg (6-12 month old) 4.0 mg (1-3 year old) 5.0 mg (>3 years old)
~Dose modification: decrease standard dose by 25% if there are signs of toxicity. Increase the dose by 25% if there is inadequate tumor response.
~Frequency: 2 treatment cycles at 3-4 week intervals, with a third treatment cycle administered if the tumor requires it.
~Dose not to exceed 0.5mg/kg, per treatment cycle."
16212823|NCT01293526|Device|Control|Patients who respond will have leads will be placed using standard procedures.
16212824|NCT01293526|Device|Experimental|Patients who respond will have their leads placed based on study measurements.
16212825|NCT01293526|Device|Experimental 2|Patients who respond will have their leads placed based on standard lead placement.
16212826|NCT01293513|Other|Gradual anti-HIV treatment interruption|Gradual interruption of anti-HIV treatment: the interruption initially for a week, up to six weeks' interruption, and continuing anti-HIV treatment for two weeks between successive interruptions
16212827|NCT01293500|Procedure|Goal-directed Therapeutic Protocol|A 10 month period of data collection for transport patients with SIRS (Systemic Inflammatory Response Syndrome) will be followed by training and institution of a goal-directed resuscitation protocol. A second 10 month data collection period will then commence. Groups will be compared with respect to outcome measures at the end of the study. All subjects will be monitored with NIRS cerebral and somatic oximetry.
16212828|NCT01293487|Biological|RN564|Intravenous, single dose with experimental dose
16212829|NCT01293474|Device|Spectralis® SD-OCT, Heidelberg Engineering GmbH, H|Measurement of the choroidal thickness with Spectralis® SD-OCT
16212830|NCT01293461|Drug|CBX129801|Subcutaneous injection
16212831|NCT01293461|Drug|Placebo|Subcutaneous injection
16212832|NCT01293448|Device|Cryoballoon Ablation|"Device: CryoBalloon Ablation System(TM) C2 Therapeutics Inc. received FDA market clearance for the CryoBalloon Ablation System on September 29, 2010. The System is a Class II device intended to be used as a cryosurgical tool for the destruction of unwanted tissue in the field of general surgery, specifically for endoscopic applications. (K101825)"
16212833|NCT01293422|Drug|Rifampicin|Rifampicin 600 mg daily for a week
16212834|NCT01293409|Other|Transcranial Brain-Targeted Bright Light Treatment|Transcranial Brain-Targeted Bright Light Treatment via Ear Canals
16212835|NCT01293396|Drug|Insulin Aspart|Patients received insulin aspart before breakfast and before lunch.
16212836|NCT01293396|Drug|Insulin Aspart 30|Patients received biphasic insulin aspart 30 before breakfast and before lunch.
16212837|NCT01293396|Drug|Insulin Aspart 70|Patients received biphasic insulin aspart 70 before breakfast and before lunch.
16212838|NCT01293383|Drug|LEO 90105|Ointment
16212839|NCT01293357|Drug|LEO 90105|Ointment
16212840|NCT01293344|Other|Controlled nutritional intervention based on the Mediterranean diet|Men are assigned to a 4 weeks isocaloric controlled nutritional intervention based on the Mediterranean diet (MedDiet) in which all foods and drinks are provided. The respective percentages of kcal derived from lipids, carbohydrates, protein and alcohol are respectively of 32%, 48%, 15% and 5%. Habitual energy intake of each participant is established by averaging energy requirements estimated by a validated food-frequency questionnaire (FFQ) and energy needs as determined by the Harris-Benedict formula. Body weight is measured on weekdays and total energy provided is revised if necessary for minimizing body weight fluctuations. This intervention period is preceded by a 4 weeks uncontrolled run-in period based on the Canada's Food Guide.
16212841|NCT01293344|Other|Controlled nutritional intervention based on the Mediterranean diet|Women are assigned to the same intervention than men in order to compare men and women metabolic response to the MedDiet.
16212842|NCT01293318|Other|No intervention|No intervention
16212843|NCT01293305|Drug|Chondroitin sulfate + Glucosamine sulfate|1 capsule three times daily, preferably in the same period
16212844|NCT01293305|Drug|Chondroitin sulfate + Glucosamine sulfate|1 sachet per day of the drug dissolved in a beaker with 200 mL water.
16212845|NCT01293292|Drug|Teriparatide|Teriparatide (Forsteo) 20 mcg subcutaneous injection once daily. Duration 104 weeks.
16212846|NCT01293266|Drug|Propofol|Anesthesia is switched from sevoflurane to propofol after obtaining a baseline blood gas analysis.
16212847|NCT01293253|Behavioral|Stair walking|Participants of the stair group is encouraged to use the stairs for 10 minutes a day at the workplace. Participants of the control group receive a health examination before and after the intervention period, and are advised to stay active
16212848|NCT01293240|Device|lotrafilcon B contact lens|Commercially marketed, silicone hydrogel contact lens worn bilaterally on a daily wear basis for up to 30 days with a two week and four week evaluation visit.
16212849|NCT01293227|Procedure|Surgical treatment of distal radius fractures|Surgical repair of distal radius fracture using either intramedullary locked nail or volar locked plate
16212850|NCT01293214|Procedure|Limb transplantation|
16212851|NCT01293201|Drug|STAHIST|STAHIST dosed one tablet, BID
16212852|NCT01293201|Drug|Placebo|Placebo identical in appearance to IMP, dosed one tablet BID
16212853|NCT01293175|Dietary Supplement|Whole grains|Subjects will consume whole grains at dose of 80 g/die, for two months
16212855|NCT01293149|Drug|Ropivacaine|ropivacaine 0.2% 0.5 ml/kg (max 20 ml)
16212861|NCT01293097|Drug|Atorvastatin|Atorvastatin 80mg/d ×2d before PCI. After PCI, atorvastatin 40mg/d until 30 days later, and then followed by usual care
16212862|NCT01293097|Drug|Statin|Usual care, but statin dose should not be higher than that described in exclusion criteria
16212863|NCT01293084|Drug|0.12% saline|5mL of 0.12% saline inhaled once over 20 minutes
16212864|NCT01293084|Drug|7% saline|5mL 7% saline inhaled once over 20 minutes
16212865|NCT01293071|Other|Antibiotic rotation|Rotation of antibiotic classes as specific preferred antibiotic class to be used for empiric treatment of ICU acquired infections.
16212866|NCT01293058|Drug|Intranasal naloxone|spray naloxone, 0.4 mg/ each 4 minutes till increasing patient level of consciousness
16212867|NCT01293058|Drug|Intravenous|Amp naloxone, 0.4 mg / each 4 minutes till increasing patient level of consciousness
16212868|NCT01293045|Dietary Supplement|hydrolyzed collagen|10g/day at breakfast during 90 days
16212869|NCT01293045|Dietary Supplement|wheat protein|10g/day at breakfast during 90 days
16212870|NCT01293032|Procedure|Neoadjuvant Therapy|Undergo neoadjuvant therapy
16212871|NCT01293032|Procedure|Therapeutic Conventional Surgery|Undergo therapeutic conventional surgery
16212872|NCT01293032|Other|Laboratory Biomarker Analysis|Correlative studies
16212873|NCT01293032|Genetic|Gene Expression Analysis|"Undergo Oncotype Dx gene expression profiling. The Oncotype DX gene expression profiling system will be used to calculate a Recurrence Score (RS)."
16212874|NCT01293032|Drug|Systemic Chemotherapy|Undergo chemotherapy
16212875|NCT01293032|Drug|Tamoxifen Citrate|Undergo hormonal therapy
16212876|NCT01293032|Drug|Aromatase Inhibition Therapy|Undergo hormonal therapy
16212877|NCT01293019|Procedure|Osteopathic treatment|Real treatment of osteopathy
16212878|NCT01293019|Procedure|Sham Placebo|Sham treatment of osteopathy
16212879|NCT01293019|Procedure|Usual care|Classical treatment of pain in cystic fibrosis patients
16212880|NCT01293006|Drug|suvorexant|one tablet (30 or 40 mg suvorexant depending on participant age: 40 mg for participants <65 years of age and 30 mg for participants ≥65 years of age), orally, once daily, for 4 consecutive days
16212881|NCT01293006|Drug|Placebo|one tablet matching suvorexant, orally, once daily, for 4 consecutive days
16212882|NCT01292993|Drug|400 mg LX4211|400 mg of LX4211 given as a solid oral dose form
16212883|NCT01292993|Drug|1000 mg metformin|1000 mg metformin given as a solid oral dose form
16212884|NCT01292980|Device|AFT bed|All identified patients will receive a AFT bed for a maximum of 21 days or until discharge
16212885|NCT01292967|Dietary Supplement|Low flavanol chocolate|48 mg of total flavanols from cocoa
16212886|NCT01292967|Dietary Supplement|High-flavanol with sugar|high-flavanol containing 251 mg cocoa flavanols
16212887|NCT01292967|Dietary Supplement|High flavanol Maltitol|high-flavanol containing 266 mg cocoa flavanols
16212888|NCT01292954|Dietary Supplement|Blueberries|low dose: 31.4 g of freeze dried blueberry reconstituted in water medium dose: 57 g of freeze dried blueberry reconstituted in water high dose: 80 g of freeze dried blueberry reconstituted in water Placebo: sugars and vitamin c match control in water Frequency:1 single time Total Duration: 3 days study over 3 weeks period
16212889|NCT01292941|Device|Intermittent catheterisation|Speedicath, Intermittent catheterisation
16212890|NCT01292941|Device|NonCE marked intermittent catheter/red|Paris, Intermittent catheterisation
16212891|NCT01292941|Device|NonCE marked intermittent catheter/green|Paris, Intermittent catheter
16212892|NCT01292941|Device|NonCE marked intermittent catheter/blue|Paris, Intermittent catheter
16212893|NCT01292928|Device|Stent implantation|Stent implantation during the index procedure.
16212894|NCT01292902|Other|inspiratory muscle exercise|To conduct the exercise to the inspiratory muscles was used for IMT Threshold ® device (Threshold Inspiratory Muscle Trainer, HealthScan Products Inc., Cedar Grove, New Jersey) is one of the most used for training of inspiratory muscles in patients with several pathologies such as ICC.Threshold ® has been engaged in the patient's mouth by a mouthpiece, with the nose occluded by a nose clip. The exercise time was 3 minutes. During this period, participants were encouraged to only breathe through the mouth and maintain a respiratory rate between 12 and 16ipm. The exercise would be stopped if HR increased more than 20% and / or SpO2 < 88%.
16212895|NCT01292902|Other|inspiratory muscle exercise|Equal to the group with chronic heart failure.
16212896|NCT01292876|Device|Extracellular Matrix|Extracellular Matrix
16212897|NCT01292863|Other|Active Comparator: Conventional peritoneal dialysis solution|Daily dialysis solution to be used for 3 months in crossover fashion.
16212898|NCT01292863|Other|Experimental: Novel biocompatible dialysis solution|Daily dialysis solution to be used for 3 months in crossover fashion.
16212899|NCT01292837|Drug|Levetiracetam|The initial dose is 20 mg/kg/day or 1000 mg/day, divided into two equal dose for the first two weeks, followed by 40 mg/kg/day or 2000 mg/day for two weeks. After reaching 60 mg/kg/day or 3000 mg/day, treatment will continue for 20 weeks.
16212900|NCT01292824|Drug|ITX 5061|ITX 5061 (150mg) pre-transplant, immediately post-transplant and daily thereafter for 1 week.
16212901|NCT01292811|Device|Functional Electrical Stimulation (Compex Motion Stimulator)|Functional electrical Stimulation:Parameters of stimulation: 1) balanced, biphasic, current regulated electrical pulses; 2) pulse amplitude from 8 to 50 mA (typical values 17-26 mA); 3) pulse width from250 to 300 μs; and 4) pulse frequency from 20 to 70 Hz (typical value 25 to 40 Hz).
16212902|NCT01292811|Other|Conventional Occupational therapy|"The Control group will receive conventional occupational therapy pertaining to hand function [15].
~The conventional therapy represents control activities against which the FES therapy will be assessed. The conventional occupational therapy includes: a) muscle facilitation exercises emphasizing the neurodevelopmental treatment approach; b) task-specific, repetitive functional training; c) strengthening and motor control training using resistance to available arm motion to increase strength; d) stretching exercises; e) electrical stimulation applied primarily for muscle strengthening (this is not FES but TENS application); f) activities of daily living including self-care where the upper limb was used as an assist if appropriate; and g) caregiver training."
16212903|NCT01292798|Drug|Ranibizumab|0.05ml of 0.5mg or 2.0mg ranibizumab injected intravitreally
16212991|NCT01292213|Procedure|Oropharyngeal swab|Samples will be tested to determine and characterise the bacteria that may be associated with chronic cough.
16212904|NCT01292785|Drug|Hormones|"FtM will receive
~1000mg testosterone undecanoate every 12 weeks (Nebido® 4ml i.m.), or alternatively 50mg testosterone transdermally (Testogel® 5g-bag per day) and
~if menstruation still occurs, additionally either lynestrenol Orgametril® (2-3 tablets/day) or in some cases 0.075mg desogestrel (Cerazette®, 1 tablet/day).
~MtF will receive
~50mg cyproterone acetate daily (Androcur®)
~estradiol 100µg transdermal therapeutic system (TTS) twice a week (Estradot®, Estramon®), especially if subjects age is > 40 years, or p.o. estradiol 2x2mg (Estrofem®) if subjects age is < 40 years; alternatively estradiol 0,75-1,5mg (1-2 hubs) transdermally (Estrogel-Gel®) and
~2,5mg alpha-5-reductase-inhibitor every 2nd day (Finasterid Actavis/ Arcana/ Aurobindo®) in case of extensive hair loss."
16212905|NCT01292772|Procedure|contract-enhanced MRI|Patients will have contrast-enhanced MRI of the breasts.
16212906|NCT01292772|Radiation|Unilateral Adjuvant Radiation Therapy|The study group will consist breasts receiving post-operative radiation, and the control group will consist of the patient's breasts on the non-radiated side. In this way, patients will act as their own control.
16212907|NCT01292746|Device|Erchonia MLS|The Erchonia MLS administers 4 diodes of 10 milliwatts (mW) 635 nanometers (nm) red light to the scalp area for 18 minutes, 2 times each week for 12 consecutive weeks for a total of 24 treatments.
16212908|NCT01292733|Other|Laboratory Tumor Marker Analysis|Performed every 6 months, these blood samples will be drawn to measure the concentration of CA125 tumor marker. Remaining samples will be stored in a specimen repository for use in future research for ovarian and breast cancer tumor markers.
16212909|NCT01292733|Other|Transvaginal Ultrasound|Performed annually, these pelvic ultrasounds will be used used to look for 1) enlargement of one or both ovaries or 2) suspicious or indeterminate morphometric parameters, determined by the presence of intracystic papillations, and/or mural nodularity.
16212910|NCT01292733|Other|Health Status Questionnaire|Performed every 6 months, these questionnaires will ask about your health and medical history, environmental exposures, and family history.
16212911|NCT01292720|Drug|Cholecalciferol|Cholecalciferol 90,000 IU followed by weekly 24,000 IU for 24 weeks of vitamin D3 (total dose: 666,000 IU)
16212912|NCT01292720|Drug|Placebo|Placebo in matching volumes
16212913|NCT01292707|Behavioral|Control|Standard national training
16212914|NCT01292707|Behavioral|HW|Prescribing staff in the intervention facilities will receive the same package of nationally-approved training in RDT use as will be provided to prescribers in control facilities. Following this, prescribers in the intervention facilities will be invited to participate in 3 small group training modules delivered in an interactive style lasting approximately 11/2 hours, with one session repeated between the 6th and 7th month of the trial
16212915|NCT01292707|Behavioral|HWC|The health worker-community arm will receive the same intervention as the health workers arm but with the addition of an intervention aimed at patients. This will consist of community sensitisation, clinic posters and providing a leaflet to each RDT-tested patient or caretaker giving details of the test and the corresponding treatment provided.
16212916|NCT01292694|Drug|Losartan|Oral, single-dose, 50 mg tablet
16212917|NCT01292694|Drug|Captopril|Oral, single-dose, 50 mg tablet
16212918|NCT01292694|Drug|Placebo|Oral, single administration, gelatin capsule filled with microcrystalline cellulose
16212919|NCT01292681|Other|Multi-modality imaging|Week -2-0 FDG-PET-CT,1H MRS, DCE-MRI, DWI Week 1 1H MRS, DCE-MRI, DWI, 19F MRS, FDG-PET-CT Week 9 FDG-PET-CT
16212920|NCT01292668|Drug|methyl-5-aminolevulinate hydrochloride cream|Applied topically
16212921|NCT01292668|Drug|photodynamic therapy|Undergo light-emitting diode photodynamic therapy
16212922|NCT01292668|Procedure|laser therapy|Undergo laser light photodynamic therapy
16212923|NCT01292655|Drug|BMS-906024|
16212924|NCT01292642|Behavioral|Cognitive Behavioral Therapy|individual CBT once weekly, 50 minutes, for 10 weeks
16212925|NCT01292642|Drug|Nicotine Replacement Therapy|"21 mg patch for 6 weeks, 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks
~14 m g patch for 8 weeks, then 7 mg patch for 2 weeks"
16212926|NCT01292629|Device|iSert 251 intraocular lens|aphakic intraocular lens
16212927|NCT01292616|Drug|therapy with disease-modifying anti rheumatic drugs (DMARD)|DMARD drug and dosage is chosen by the treating physician without restriction by the study
16212928|NCT01292603|Drug|Cyclophosphamide|Days 1-3 or Days 1-5 of cycles 1-6
16212929|NCT01292603|Drug|Fludarabine|Days 1-3 or Days 1-5 of cycles 1-6
16212930|NCT01292603|Drug|rituximab [MabThera]|One cycle of intravenous MabThera, followed by 5 cycles of subcutaneous MabThera
16212931|NCT01292603|Drug|rituximab [MabThera]|After 4 cycles of intravenous MabThera without experiencing grade 3 or 4 infusion-related reactions. patients will receive 1 additional cycle of intravenous MabThera and 1 cycle of subcutaneous MabThera.
16212932|NCT01292603|Drug|rituximab [MabThera]|6 cycles of intravenous MabThera
16212933|NCT01292590|Other|High fat meal|40 grams saturated fat
16212934|NCT01292577|Behavioral|CET/PT|CET/PT is an 18-month comprehensive small group approach for the remediation of cognitive deficit in schizophrenia consisting of individual sessions and 45 group training sessions in social cognition that are integrated with an affect regulation approach and 60 hours of computer assisted training in attention, memory, and problem solving skills.
16212935|NCT01292577|Behavioral|Treatment as Usual|The usual care individuals with schizophrenia that misuse substances receive in the community for their conditions.
16212936|NCT01292564|Device|Erchonia MLS|The Erchonia MLS emits 635 nm low level laser light.
16212937|NCT01292564|Device|Placebo Laser|The Placebo Laser looks identical to the Erchonia MLS Laser but emits no therapeutic light.
16212938|NCT01292551|Drug|Bosentan|tablets Bosentan 62,5 mg x 2 daily for two weeks, then 125 mg x 2 daily for 12 weeks
16212939|NCT01292551|Drug|Placebo|Placebo tablets 2 x daily for 2 weeks, then change to different placebo tablets to match Bosentan group, 2 x daily for 12 weeks
16212940|NCT01292538|Device|Erchonia GLS|532 nm green diode low level laser light device
16212941|NCT01292538|Device|Placebo laser|Sham light output with no therapeutic benefit
16212942|NCT01292525|Drug|Tacrolimus|"A control group continued conventional therapy, Tacrolimus (Prograf®) (control group) and will be followed in parallel group withdrawal that will stop treatment with Tacrolimus (Prograf®)."
16212992|NCT01292213|Procedure|Nasopharyngeal swabs|Samples will be tested to determine and characterise the bacteria and viruses that may be associated with chronic cough.
16212943|NCT01292525|Drug|Placebo|"Patients randomized to the withdrawalgroup will begin the protocol with their usual dose of Tacrolimus (Prograf®) (initial dose). The initial dose of tacrolimus (Prograf®) will be reduced by one third at visit 3 (day 0) and again a third visit 5 (J60). The complete withdrawal Tacrolimus (Prograf®) begins to visit 7 (J120). The withdrawal of Tacrolimus (Prograf®) will be obtained in four months. Monitoring of all patients lasted 17 months in total from the screening visit, which corresponds to 12 months after complete withdrawal of Tacrolimus (Prograf®) for patients in the withdrawal group."
16212944|NCT01292512|Other|Prognostic screening for complicated grief|Patients in the intervention group are prognostically screened for development of complicated grief to identify those in need of help.
16212945|NCT01292499|Behavioral|Psychotherapy|10 sessions (50 min)
16212946|NCT01292499|Behavioral|Psychoeducation|7 sessions + 7 phone calls
16212947|NCT01292499|Behavioral|Psychoeducation and psychotherapy|Psychoeducation + psychotherapy
16212948|NCT01292486|Device|Spectra Optia Apheresis System|In this study, the safety and effectiveness of the new device will be assessed in two ways. First, MNC collections in growth-factor mobilized cancer patients will be evaluated to confirm that the Spectra Optia is able to collect stem cells. Second, following stem-cell collection and transplant, the number of days required for the collected hematopoetic stem cells to engraft/recover will be compared with historical COBE Spectra engraftment/recovery data.
16212949|NCT01292473|Drug|Placebo|Placebo was supplied lyophilized in vials.
16212950|NCT01292473|Drug|Omalizumab|Omalizumab was supplied lyophilized in vials.
16212951|NCT01292460|Drug|Timolol/ FDC/ Placebo/ Tafluprost|"Prior timolol users: Timolol (administered at 08:00 and 20:00) or FDC of tafluprost and timolol (at 08:00) and Placebo eye drops (at 20:00).
~Prior prostaglandin users: Tafluprost (administered at 08:00) or FDC of tafluprost and timolol (administered at 08:00)."
16212952|NCT01292447|Drug|2% lidocaine gel|120mg lidocaine x 1
16212953|NCT01292447|Drug|Placebo gel|Inert gel x 1
16212954|NCT01292434|Behavioral|Lunch is in the Bag behavioral intervention|Multi-component behavior-based activities, includes: parent handouts, teacher training, age-appropriate child classroom activities, parent/child activity stations
16212955|NCT01292421|Biological|hepatitis B antigen peptide|Given PO
16212956|NCT01292421|Other|placebo|Given orally (PO)
16212957|NCT01292421|Other|immunoenzyme technique|Correlative studies
16212958|NCT01292408|Drug|Hydrochloroquine|800 mg per os once, and then 400 mg per day
16212959|NCT01292395|Other|Dietary Protein Intake|Protein intakes within the current recommendation
16212960|NCT01292382|Device|Repetitive transcranial magnetic stimulation|Intensity: 110% of motor threshold Frequency: 10 Hz Number of trains: 40 trains Duration of trains: 5 seconds Interval: 25 seconds Number of sessions: 10 sessions Duration of intervention: two consecutive weeks
16212961|NCT01292382|Device|Repetitive transcranial magnetic stimulation|Intensity: 110% of motor threshold Frequency: 10 Hz Number of trains: 40 Duration of trains: 5 seconds Interval inter trains: 25 seconds Number of pulses each session: 2.000 Total number of pulses: 20.000
16212962|NCT01292356|Drug|cetuximab|
16212963|NCT01292343|Other|Colgate Total Toothpaste|Toothbrushing with Colgate Total Toothpaste
16212964|NCT01292343|Other|Colgate Regular Toothpaste|Toothbrushing with Colgate regular toothpaste
16212965|NCT01292330|Procedure|nutritional support before operation|nutritional support before operation for more than 4 days
16212966|NCT01292317|Other|application of intravenous volume|weight based intravenous application of volume
16212967|NCT01292317|Other|oral fluid application|oral fluid application
16212968|NCT01292304|Drug|Tolvaptan|Oral administration once daily Dosage will range from 15 mg to 30 mg
16212969|NCT01292291|Other|biologic sample preservation procedure|
16212970|NCT01292291|Other|laboratory biomarker analysis|
16212971|NCT01292291|Other|study of socioeconomic and demographic variables|
16212972|NCT01292291|Procedure|diffusion-weighted magnetic resonance imaging|
16212973|NCT01292291|Procedure|dynamic contrast-enhanced magnetic resonance imaging|
16212974|NCT01292291|Procedure|multiparametric magnetic resonance imaging|
16212975|NCT01292291|Procedure|quality-of-life assessment|
16212976|NCT01292291|Procedure|transperineal prostate biopsy|
16212977|NCT01292291|Procedure|transrectal prostate biopsy|
16212978|NCT01292291|Procedure|ultrasound-guided prostate biopsy|
16212979|NCT01292265|Biological|Certolizumab Pegol|Certolizumab Pegol (CZP) subcutaneous (sc) injections of 400 mg at Weeks 0, 2 and 4, followed by 200 mg at Weeks 6, 8 and 10.
16212980|NCT01292252|Biological|teriparatide|Teriparatide 20 ug subcutaneous injection daily for 12 weeks
16212981|NCT01292252|Biological|Placebo|Saline solution
16212982|NCT01292239|Drug|Placebo|Placebo capsule taken by mouth once daily for 12 weeks
16212983|NCT01292239|Drug|TMC435|100-mg capsule taken by mouth once daily for 12 weeks
16212984|NCT01292239|Drug|Peginterferon alfa-2a (pegIFN alfa-2a)|PegIFN alfa-2a (PEGASYS) will be administered according to the manufacturer's prescribing information as 180 mcg once weekly injected subcutaneous (under the skin) for up to 24-48 weeks for patients randomized to TMC435 and for up to 48 weeks for patients randomized to placebo.
16212985|NCT01292239|Drug|Ribavirin (RBV)|RBV (COPEGUS) will be administered according to the manufacturer's prescribing information. If body weight is > 80 kg the total daily dose of RBV will be 1000 mg, taken by mouth as 400 mg (2 tablets of 200 mg) after breakfast and 600 mg (3 tablets of 200 mg) after supper. If body weight is > 60 kg to <=80 kg the total daily dose will be 800 mg, taken by mouth as 400 mg (2 tablets of 200 mg per intake) after breakfast and supper. If body weight is <=60 kg the total daily dose of RBV will be 600 mg, taken by mouth as 200 mg (1 tablet of 200 mg) after breakfast and 400 mg (2 tablets of 200 mg) after supper. Total duration of RBV will be 24-48 weeks.
16212986|NCT01292226|Drug|mycophenolate mofetil|1 g PO BID for 24 weeks
16212987|NCT01292226|Drug|antibody induction|According to manufacturer recommendation
16212988|NCT01292226|Drug|Cyclosporine|According to manufacturer recommendation
16212989|NCT01292226|Drug|corticosteroid|According to manufacturer recommendation
16212990|NCT01292213|Procedure|Cough swab|Samples will be tested to determine and characterise the bacteria that may be associated with chronic cough.
16213059|NCT01291654|Drug|Paracetamol|po Paracetamol 15 mg/kg every 6 hours x 3 days
16212993|NCT01292213|Procedure|Blood sample|Samples will be tested to determine and characterise the immunological markers that may be associated with chronic cough.
16212994|NCT01292213|Procedure|Bronchoscopy/ bronchoalveolar lavage samples|Samples will be tested to determine and characterise the bacteria, viruses and immunological markers that may be associated with chronic cough.
16212995|NCT01292213|Other|Data collection|Questionnaire completion.
16212996|NCT01292200|Behavioral|watch DVD and small group discussion|Women in the small-group discussion mode will be called by their community educators to determine possible dates, times, and places for group meetings. The small group sessions will be conducted near the participants' homes. Each small-group will consist of 5-10 participants who will first view a 20-minute video together and then discuss the content of the video as well as their barriers to screening for about 30 minutes. A community educator and an RA at the study site will facilitate the discussion in Chinese languages according to a structured guide.
16212997|NCT01292200|Behavioral|watch DVD|Women in the single video mode will receive a cultural video along with an information sheet on local free and low-cost screening programs by mail.
16212998|NCT01292187|Drug|Oral calcitonin at dinnertime|Oral calcitonin at dinnertime.
16212999|NCT01292187|Drug|Oral placebo at dinnertime|Oral placebo at dinnertime.
16213000|NCT01292187|Drug|Oral calcitonin at bedtime|Oral calcitonin at bedtime
16213001|NCT01292187|Drug|Oral placebo at bedtime|Oral placebo at bedtime
16213002|NCT01292174|Biological|ibalizumab (biologic/MAb) for SC Injection or placebo|ibalizumab or matching placebo administered by subcutaneous injection weekly at 120 mg
16213003|NCT01292174|Biological|ibalizumab (biologic/MAb) for SC Injection or placebo|ibalizumab or matching placebo administered by subcutaneous injection weekly at 240 mg
16213004|NCT01292174|Biological|ibalizumab (biologic/MAb) for SC Injection or placebo|ibalizumab or matching placebo administered by subcutaneous injection weekly at 480 mg
16213005|NCT01292161|Drug|Silymarin|Tab 210 mg, 630 mg, daily, six months.
16213006|NCT01292135|Drug|PCI-32765|420 mg daily
16213007|NCT01292122|Device|VCT-01|Application of bi-layered living cell-based product (VCT-01) to STSG donor site wound at Day 0
16213008|NCT01292109|Drug|sodium picosulphate|Sodium picosulphate (PICOPREP®) taken by participant prior to X-ray examination, endoscopy or surgery.
16213009|NCT01292096|Other|Provision of extra (care coordination and management) services|The pilot intervention begins at the patient's bedside in the hospital and continue after his/her discharge into the community, utilizing a flexible and intensive care management model with a multi-disciplinary team approach. Community Based Care Managers (CBCMs) overseen by a social worker, will connect patients to needed community services including housing for homeless patients, accompany patients to appointments and facilitate transportation to medical, benefits enrollment, and perform other services based in the hospital and community.
16213010|NCT01292083|Drug|azacitidine|Given IV
16213011|NCT01292083|Other|laboratory biomarker analysis|Correlative studies
16213012|NCT01292083|Other|immunohistochemistry staining method|Correlative studies
16213013|NCT01292083|Genetic|polymerase chain reaction|Correlative studies
16213014|NCT01292083|Genetic|western blotting|Correlative studies
16213015|NCT01292083|Genetic|nucleic acid sequencing|Correlative studies
16213016|NCT01292083|Procedure|therapeutic conventional surgery|Undergo definitive breast surgery
16213017|NCT01292070|Biological|Intradermal Human Fcγ1-Fel d1 fusion protein|"Part A: 7 sequential 10-fold dose increments from 0.001 BAU/mL to 1,000 BAU/mL; An 8th dose of 10,000 BAU/mL might be given only if the 10 BAU/mL of CAT is the dose that elicits a bump or hive of >= to 10mm.
~Part B: 5 sequential 10-fold dose increments from 0.1 BAU/mL to 1,000 BAU/mL; An 6th dose of 10,000 BAU/mL might be given only if the 10 BAU/mL of CAT is the dose that elicits a bump or hive of >= to 10mm."
16213018|NCT01292070|Biological|Positive Control - standardized cat hair allergenic extract (CAT)|4 sequential 10-fold injections starting from 0.01 BAU/mL to 10 BAU/mL
16213019|NCT01292070|Biological|Positive Control - Histamine Prick|1.0 mg/mL
16213020|NCT01292070|Biological|Negative Control - Intradermal Diluent|Saline, Albumin with Phenol (HSA) sterile diluent
16213021|NCT01292057|Drug|Aripiprazole|Aripiprazole(up to 15 mg/day) for 8 days
16213022|NCT01292057|Drug|Placebo|Placebo to match active drug Aripiprazole for 8 days
16213023|NCT01292044|Other|Elastography|A conventional thyroid echography performed before a the time of fine needle aspiration will include elastographic measurements for each node under study.
16213024|NCT01292031|Drug|Colistin|Colistin 4.5 MU/iv plus Colistin 3 MU/iv./8 h. 30 minutes infusion
16213025|NCT01292031|Drug|Meropenem|Meropenem 2 g/iv/ 8 h. 30 minutes infusion
16213026|NCT01292005|Drug|Pentoxifylline|400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
16213027|NCT01292005|Drug|Placebo|400 mg, 3 times daily by mouth from time of enrollment until 72 hours from enrollment. Subjects received up to a maximum of 9 doses.
16213028|NCT01291979|Drug|Intravenous lidocaine injection|Patients in Group I (intravenous lidocaine injection group) received an intravenous bolus injection of 1.5 mg/kg lidocaine followed by a continuous lidocaine infusion of 2 mg/kg/hr.
16213029|NCT01291979|Drug|Intravenous normal saline injection|The patients in Group C (placebo control group) received normal saline intravenous injection
16213030|NCT01291966|Behavioral|Motivational interview|
16213031|NCT01291953|Procedure|Screening|Determination of the arterial pulse and if it is arrhythmic, accomplishment of an ECG
16213032|NCT01291953|Procedure|Control|Determination of the arterial pulse and if it is arrhythmic, accomplishment of an ECG
16213033|NCT01291940|Other|Pediatric Moisturizer|Apply moisturizer for four weeks daily to only one arm. Do not apply moisturizer to the other arm.
16213034|NCT01291940|Other|Adult Moisturizer|Apply moisturizer for four weeks daily to only one arm. Do not apply moisturizer to the other arm.
16213060|NCT01291654|Drug|NSAID|IV indomethacin 2 mg/kg/dose for three doses at 12 hour intervals; or IV Ibuprofen 10 mg/kg infused over 15 minutes, followed by two doses of 5mg/kg each at 24 hour intervals (total of 3 doses).
16213061|NCT01291654|Drug|D5W|Since the paracetamol is given q 6 hours, in order to maintain blinding of the clinical staff, a placebo (D5W) must be given intermittently between the doses of NSAID such that each infant will receive drug every 6 hours.
16213035|NCT01291927|Procedure|Pancreas-sparing duodenectomy|Pancreas-sparing duodenectomy for periampullary carcinoma is defined as resection of the descending segment of duodenum; resection of papilla of Vater; reimplantation of bile and pancreatic ducts and reconstruction of duodenum.The Japan Pancreatic Society (JPS) system for numbering of lymph node stations was adopted for accurate description of the surgery and pathological assessment.The standard lymph node groups removed as part of PSD were the anterior pancreatoduodenal groups (JPS LN17), the posterior pancreatoduodenal groups (JPS LN13), the dextroinferior nodes of the hepatoduodenal ligament node groups (JPS LN12), the infrapyloric node (JPS LN6), the nodes around the anterior aspect of the common hepatic artery (JPS LN8) and the nodes on the right side of the SMA (JPS LN14).
16213036|NCT01291927|Procedure|Pancreaticoduodenectomy|The surgical technique used for standard PD has been described before. Standard PD included clearance of all soft tissues and lymphatics immediately to the left of the superior mesenteric artery, as well as removal of the lymphoareolar tissue along the proximal hepatic artery.
16213037|NCT01291914|Drug|FX005|Single Ascending Dose (SAD) Phase Cohorts: 1, 10 or 45 mg intra-articular injection; Proof of Concept Phase: Maximum, well-tolerated dose intra-articular injection (determined during SAD Phase)
16213038|NCT01291914|Drug|Placebo 1 (Carrier)|Single intra-articular injection
16213039|NCT01291914|Drug|Placebo 2 (Diluent)|Single intra-articular injection
16213040|NCT01291901|Biological|NP2|NP2 is a replication defective HSV-1 based gene transfer vector engineered to express human preproenkephalin. The drug will be injected intradermally corresponding to the distribution of the malignancy-related pain. The total amount to be injected will be a dose volume of 1.0 ml delivered in a single session on Study Day 0.
16213041|NCT01291901|Biological|Placebo|The placebo (vehicle) will be injected intradermally corresponding to the distribution of the malignancy-related pain. The total amount to be injected will be a dose volume of 1.0 ml delivered in a single session on Study Day 0.
16213042|NCT01291875|Procedure|non-surgical periodontal treatment|Patients in this group will receive a non surgical periodontal therapy: scaling and root planing of the root surfaces under local analgesia (depending on the severity in one session or two sessions within 2 days). Any tooth that from the baseline examination is defined as hopeless or irrationale to treat will be extracted. After to 2 months re-assessment presenting at least one periodontal site with pocket depth of 6 mm will have additional corrective periodontal therapy.
16213043|NCT01291875|Procedure|Supragingival biofilm control|Control group patients will receive a standard cycle of supra-gingival mechanical instrumentation and polishing in one appointment performed as appropriate by a single clinician using a combination of hand and machine driven (piezoelectric) instrumentation.
16213044|NCT01291862|Device|Watchpat 100|Watchpat 100 is a noninvasive portable sleep monitoring device which monitors peripheral arterial tone, pulse, oxygen saturation, snoring, and body position. Patient places one probe at his or her finger and another sensor at front of the chest and Watchpat 100 monitors the patient overnight.
16213045|NCT01291849|Drug|Dixon up-and-down method|The target Ce of remifentanil was determined by the response of the previous patient using Dixon's up-and-down method. If the patients did not cough throughout peri-extubation period, the extubation was defined as a smooth emergence, and the predetermined concentration of remifentanil for the subsequent patient was decreased by 0.5 ng ml-1. Similarly, if the patient cough anytime around extubation it was considered as failed smooth emergence and the predetermined concentration was increased by 0.5 ng ml-1 for the next patient. The patients were enrolled until getting at least six cross-over pairs in Dixon sequential allocation method.
16213046|NCT01291823|Drug|gefitinib|gefitinib 250mg/day
16213047|NCT01291823|Radiation|Thoracic radiotherapy|Thoracic radiotherapy 54-60Gy over 30 fraction
16213048|NCT01291810|Biological|TNF Kinoid|TNF Kinoid
16213049|NCT01291810|Biological|WFI|WFI
16213050|NCT01291784|Biological|monoclonal antibody to TGF-beta|starting dose of 1mg/kg intravenous over approximately 1 hour every 4 weeks for a total of 6 doses
16213051|NCT01291771|Procedure|Invasive FFR + CFR measurements are performed during coronary angiography using a pressure guide wire|The guide is placed in the distal segment of the coronary artery to measure instantaneously distal pressure and temperature with a tip sensor. Proximal pressure and temperature are being measured from the probe used to catheterize the coronary vessel and from the shaft of the guide. After basal measurement, intracoronary injection of 150µg of adenosine is performed to induce peripheral vasodilatation leading to hyperaemia in the vessel. Additional injection of 3mL 0.9% saline bolus at room temperature at the time of hyperaemia is performed to calculate CFR from transit mean time. FFR and CFR are being recorded at the time of hyperaemia. Subsequently IMR is being calculated from distal pressure and transit mean time. The measurements will be performed in the LAD, circumflex and right coronary arteries.
16213052|NCT01291758|Diagnostic Test|Submaximal bicycle exercise stress tests performed 24 hr apart|Submaximal bicycle exercise stress tests were performed for 25 min at 70% predicted heart rate, then ramped up to 85% predicted heart rate. Subjects could stop when they felt they had reached their maximum effort if before reaching 85% predicted heart rate.
16213053|NCT01291732|Drug|Matching placebo|single dose of matching placebo
16213054|NCT01291732|Drug|BI 135585 XX|single dose of low, medium or high dose of BI 135585 XX
16213055|NCT01291719|Device|glucose and insulin infusions|combined algorithm directed glucose and insulin infusion with 5 minute blood glucose measurements to direct glucose control; regular insulin and glucose are infused intravenously as adjusted by the algorithm without manual intervention in the group of diabetic individuals under study to adjust the glucose level to a target range of 80-180 mg/dl
16213056|NCT01291706|Device|Transcranial Doppler|Negative predictive value of transcranial doppler in patients with mild to moderate traumatic brain injury
16213057|NCT01291693|Behavioral|Personal Counseling|At three time-points, participants receive counseling by health professionals trained in Motivational Interviewing based counseling. To assure that both interventions do not differ in their content, individual manuals generated by a software program are used. Counseling will be face-to-face during the hospital stay, and by phone one and three months later.
16213058|NCT01291693|Behavioral|Computer-generated feedback letters|At three time points, participants receive feedback letters, tailored to the stages of change according to the TTM, and generated by a computer software program. The first letter is handed out during their hospital stay and includes normative feedback. One and three months later, participants receive ipsative feedback letters by mail.
16214049|NCT01284504|Drug|Celecoxib|200 mg tablet oral
16213062|NCT01291641|Drug|HMG-CoA Reductase Inhibitor|"During the study period, HMGCoA reductase inhibitor is continuously administered to the patients.
~Dosage regimen: following the package insert of each HMGCoA reductase inhibitor"
16213063|NCT01291641|Drug|Probucol|"In addition to the continued HMGCoA reductase inhibitor treatment, probucol is administered.
~Dosage regimen: probucol 250-mg tablet, oral administration twice daily with meal(breakfast and dinner)"
16213064|NCT01291641|Drug|Cilostazol|"In addition to the continued HMGCoA reductase inhibitor treatment, probucol and cilostazol are administered.
~Dosage regimen: probucol 250-mg tablet, oral administration twice daily with meal(breakfast and dinner) Cilostazol 100-mg tablet, twice daily by the oral route"
16213065|NCT01291628|Device|socks containing copper-oxide fibers|The patients will use a sock which contains copper fibers. The socks are sold in the free market (different Pharma stores) for various purposes such as prevention of diabetic foot. It is a product of Cupron company EPA :84542-2, 84542-3 from April 30 2009.
16213066|NCT01291615|Drug|Gemcitabine|800mg/m2 - 1000mg/m2, day 1 every 3 weeks. day 1, 15 every 4 weeks. day 1, 8 every 3 weeks. day 1, 8, 15, every 4 weeks
16213067|NCT01291615|Drug|S-1|S-1 40mg/day - 120mg/day (depend on body surface area) day 1-14, every 3 weeks day 1-28, every 6 weeks.
16213068|NCT01291602|Drug|NXL104|IV Solution
16213069|NCT01291602|Drug|CAZ104|IV Solution
16213070|NCT01291602|Drug|Placebo|IV saline
16213071|NCT01291589|Behavioral|Cognitive-behavioral therapy|Treatment will include elements from effective interventions for reducing risky sexual behaviors
16213072|NCT01291576|Procedure|Rectal/colorectal segmental resection|Resection of the rectum +/- sigmoid colon involved by the deep infiltrating endometriosis
16213073|NCT01291576|Procedure|Rectal nodule excision|Either full thickness excision or rectal shaving
16213074|NCT01291563|Drug|Moxifloxacin|1 capsule of moxifloxacin (400 mg/capsule) on Day 2
16213075|NCT01291563|Drug|TMC207|8 tablets of TMC207 (100 mg/tablet) on Day 1
16213076|NCT01291563|Drug|TMC207 placebo|8 tablets of TMC207 placebo on Day 1
16213077|NCT01291563|Drug|Moxifloxacin placebo|1 capsule of moxifloxacin placebo on Day 2
16213078|NCT01291537|Drug|Duodopa|
16213079|NCT01291537|Drug|best médical treatment|
16213080|NCT01291524|Drug|Pregabalin controlled release, 330 mg, 400 to 500 calorie|A single oral dose of 330 mg controlled release tablet administered following a 400 to 500 calorie evening meal
16213081|NCT01291524|Drug|Pregabalin controlled release, 330 mg, 600- 750 calorie|A single oral dose of 330 mg controlled release tablet administered following a 600 to 750 calorie evening meal
16213082|NCT01291524|Drug|Pregabalin controlled release, 330 mg, bedtime|A single oral dose of 330 mg controlled release tablet administered at bedtime
16213083|NCT01291524|Drug|Pregabalin immediate release, 300 mg|A single oral dose of 300 mg immediate release capsule administered in the evening
16213084|NCT01291511|Drug|Iloperidone|Iloperidone capsules/tablets will be administered orally using a bid schedule; the strengths used include 1, 2, 4, 6, 8, 10, and 12 mg.
16213085|NCT01291511|Drug|Placebo|Matching placebo capsules will be administered orally duins a bid schedule during the double-blind period.
16213086|NCT01291498|Device|High Intensity Focused Ultrasound|One or two HIFU sessions
16213087|NCT01291485|Behavioral|Life Steps for Medication Adherence|The intervention was adapted into an electronic version of the empirically supported Life Steps intervention for HIV medication adherence. Education about HIV and medication adherence, motivational interviewing, cognitive behavioral techniques, and problem-solving strategies to improve medication adherence and clinical outcomes in people living with HIV were also included in the intervention.
16213088|NCT01291472|Drug|Ketorolac Tromethamine|After dilution (solution for injection, 10 mg/1ml) in 50-100 ml bag of normal saline drug will be administered by iv bolus, through a peripherally inserted venous catheter, 30 mg, 3 times in one day. The intended duration of administration is 5-10 minutes.
16213089|NCT01291459|Drug|MVC/RAL/FTC/TDF followed by Maraviroc/Raltegravir|MVC/RAL/FTC/TDF 24W followed by MVC/RAL until W48.
16213090|NCT01291446|Dietary Supplement|High flatulogenic diet|During 3-days subjects will consume a diet with high content of fermentable residues
16213091|NCT01291433|Drug|Pentoxifylline placebo|Placebo for pentoxifylline 400 mg, 1 cp twice a day (7d/7)
16213092|NCT01291433|Drug|Pentoxifylline|Pentoxifylline 400 mg: 1 cp twice a day (7d/7)
16213093|NCT01291433|Drug|Tocopherol acetate|Tocopherol alpha-acetate, 500 mg: 1 capsule twice a day (7d/7)
16213094|NCT01291433|Drug|Clodronic Acid|Clodronate disodium (clodronic acid) 800 mg: 2 cp per day, 5d/7 (from monday to friday)
16213095|NCT01291433|Drug|Tocopherol placebo|Placebo for Tocopherol alpha-acetate, 500 mg: 1 capsule twice a day (7d/7)
16213096|NCT01291433|Drug|Clodronate placebo|Placebo for clodronate disodium (clodronic acid) 800 mg: 2 cp per day, 5d/7 (from monday to friday)
16213097|NCT01291420|Biological|autologous dendritic cell vaccination|4 biweekly intradermal DC injections of 10*10E6 DCs (500 µL) at 5 sites (100 µL/site) in the ventromedial regions of the upper arm approximately 5-10 cm of the regional lymph nodes
16213098|NCT01291407|Drug|S-1|S-1,30mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.
16213099|NCT01291407|Drug|S-1|S-1,40mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.
16213100|NCT01291407|Drug|S-1|S-1,50mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner
16213101|NCT01291407|Drug|S-1|S-1,60mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.
16213102|NCT01291407|Drug|S-1|S-1,70mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.
16213103|NCT01291407|Drug|S-1|S-1,80mg/m2/d,peroral BID,in treatment days concurrently with radiation therapy in a standard manner.
16213104|NCT01291394|Device|Easypod™|Saizen (Somatotropin) as per Summary of Product Characteristics administered by Easypod™
16213105|NCT01291381|Drug|Dermatophagoides pteronyssinus|Children undergoing subcutaneous immunotherapy were given Dermatophagoides pteronyssinus extract (Alutard SQ, ALK-Abello, Hørsholm, Denmark) according to a cluster protocol
16213106|NCT01291381|Drug|Pharmacotherapy|For patients randomized to non-SIT group, persistent rhinitis was managed with pharmacotherapy including intranasal steroids and oral antihistamines. Intranasal steroids were kept at the same dose during the study and antihistamines were used as required.
16213107|NCT01291355|Other|Specific maternal position during the labor|"women allocated to intervention group will be invited to adopt a posture all fours type:support on the knees, torso tilted forward, back stretched for a minimum of 10 minutes. A cushion is placed between the legs of the woman to limit the cuts."
16213108|NCT01291329|Genetic|intracoronary human umbilical WJ-MSC transfer|intracoronary infusion of WJ-MSCs or placebo medium into the infarct artery 4-7 days after successful reperfusion therapy.
16213109|NCT01291316|Drug|Clonazepam|clonazepam, 1 mg, single oral dose
16213110|NCT01291316|Drug|Tolterodine|Tolterodine 1,37mg, single oral dose
16213111|NCT01291316|Drug|clobazam|clobazam 20 mg, single oral dose
16213112|NCT01291303|Procedure|Optimized ventilation|Patients, ventilated in pressure support mode, were ventilated with initial setting PEEP and pressure support of 4 and as maximum tolerated cmH2O, inspiratory and expiratory trigger of 5 L/min and 50% of peak inspiratory flow, with changes driven by the analysis of flow and pressure curves; with a FiO2 to reach a SpO2 level between 88 and 92%.
16213113|NCT01291303|Procedure|Standard ventilation|"Patients, ventilated in pressure support mode, were ventilated with standard setting of ventilation:
~-same initial setting, same time at the bedside (15 minutes at the beginning of NIV, and 5 minutes at each patients' new evaluation) same physician that optimized ventilation mode, while the ventilator screen was obscured (numerical data were, however, always available)."
16213114|NCT01291290|Procedure|Platelet|2 portions of platelets (one portion = pooled from 4 donors, 350ml) infused when diagnosed with rAAA and vascular surgeon accepts to receive the patient, infused before transportation.
16213115|NCT01291277|Device|Endoscopic Variceal Ligation|Ligation of esophageal varices
16213116|NCT01291238|Behavioral|Healthier, Smarter, Happier|Increased physical activity and decreased sugar and fat intake during school hours
16213117|NCT01291225|Other|Playground renovation and development|Playgrounds in Chillicothe will be renovated based on priorities determined by audits.
16213118|NCT01291225|Behavioral|Educational campaign|Educational materials will be developed and distributed in Ross County.
16213119|NCT01291212|Drug|Testosterone and FSHr-LHr|75U of LHr added to FSHr ovarian stimulation in IVF, when testosterone was used to improve the ovarian response
16213120|NCT01291212|Drug|testosterone and FSHr alone|FSHr alone used in ovarian stimulation in IVF, when testosterone was used to improve the ovarian response
16213121|NCT01291199|Drug|vardenafil|10 mg p.o. bid for 6 weeks
16213122|NCT01291199|Drug|Placebo|Placebo p.o. 6 weeks bid
16213123|NCT01291186|Drug|BPV6NO|intrathecal bupivacaine 6 mg for BMI less than 27.5 kg/m2
16213124|NCT01291186|Drug|BPV7NO|intrathecal bupivacaine 7 mg for BMI less than 27.5 kg/m2
16213125|NCT01291186|Drug|BPV8NO|intrathecal bupivacaine 8 mg for BMI less than 27.5 kg/m2
16213126|NCT01291186|Drug|BPV9NO|intrathecal bupivacaine 9 mg for BMI less than 27.5 kg/m2
16213127|NCT01291186|Drug|BPV10NO|intrathecal bupivacaine 10 mg for BMI less than 27.5 kg/m2
16213128|NCT01291186|Drug|BPV11NO|intrathecal bupivacaine 11 mg for BMI less than 27.5 kg/m2
16213129|NCT01291186|Drug|BPV6O|intrathecal bupivacaine 6 mg for BMI over 27.5 kg/m2
16213130|NCT01291186|Drug|BPV7O|intrathecal bupivacaine 7 mg for BMI over 27.5 kg/m2
16213131|NCT01291186|Drug|BPV8O|intrathecal bupivacaine 8 mg for BMI over 27.5 kg/m2
16213132|NCT01291186|Drug|BPV9O|intrathecal bupivacaine 9 mg for BMI over 27.5 kg/m2
16213133|NCT01291186|Drug|BPV10O|intrathecal bupivacaine 10 mg for BMI over 27.5 kg/m2
16213134|NCT01291186|Drug|BPV11O|intrathecal bupivacaine 11 mg for BMI over 27.5 kg/m2
16213135|NCT01291173|Drug|lisdexamfetamine dimesylate (SPD489)|SPD489-30mg capsules taken once daily for up to 11 weeks
16213136|NCT01291173|Drug|lisdexamfetamine dimesylate (SPD489)|SPD489 50mg capsules taken once-daily for up to 11 weeks
16213137|NCT01291173|Drug|lisdexamfetamine dimesylate (SPD489)|SPD489 70mg capsule taken once-daily for up to 11 weeks
16213138|NCT01291173|Drug|Placebo|Placebo capsule taken once daily for up to 11 weeks
16213139|NCT01291160|Device|Epiflo|During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first.
16213140|NCT01291160|Other|Moist Wound Therapy|During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first.
16213141|NCT01291147|Drug|Levobupivicaine|levobupivicaine 0.5% continous infusion for 48 hours
16213142|NCT01291147|Drug|0.9% Saline|0.9% saline continous infusion for 48 hours
16213143|NCT01291134|Biological|PureGen Osteoprogenitor Cell Allograft|PureGen Osteoprogenitor Cell Allograft.
16213144|NCT01291121|Procedure|Intravitreal expansile gas and ranibizumab injection|Intravitreal expansile gas (0.3 cc C3F8) and 0.5mg ranibizumab at day 0 Additional 3 monthly loading injection of intravitreal ranibizumab Additional injection of ranibizumab as needed
16213145|NCT01291108|Drug|AGN-210669|AGN-210669 0.05% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
16213146|NCT01291108|Drug|bimatoprost|bimatoprost ophthalmic solution 0.03% applied as 1 drop in both eyes every evening during Month 1 or Month 2.
16213147|NCT01291108|Drug|bimatoprost vehicle|bimatoprost ophthalmic solution 0.03% vehicle applied as 1 drop in both eyes every evening during Month 2.
16213148|NCT01291095|Drug|CISPLATIN|"IN CRT ARM:RADIATION ONE FRACTION PER DAY, ON FIVE CONSECUTIVE DAYS FROM MONDAY TO FRIDAY ALONG WITH INTRAVENOUS CISPLATIN 40mg/m2 WEEKLY FOR SEVEN DOSES.
~IN AFRT ARM: PATIENTS WILL NOT RECEIVE ANY CHEMOTHERAPY WITH CISPLATIN"
16213191|NCT01290783|Drug|HA-Irinotecan solution for Infusion|"HA-Irinotecan (irinotecan 180 mg/m2), IV, over 90 minutes, day 1 (in patients > 75 years of age, the irinotecan dose in must be reduced to 150 mg/m2).
~Leucovorin, 400 mg/m2, or levoleucovorin, 200 mg/m2, IV over 90 minutes with irinotecan.
~5-FU, 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion.
~Repeat every two weeks
~8 months of treatment."
16213192|NCT01290770|Other|blood sample|blood sample at inclusion and 1 month after inclusion
16213193|NCT01290757|Drug|Dabigatran etexilate|150 mg Capsugel (T)
16213149|NCT01291095|Radiation|EXTERNAL BEAM RADIOTHERAPY|Patients assigned to CRT arm will be given radiation one fraction per day, on five consecutive days from Monday to Friday along with intravenous cisplatin 40 mg/m2 weekly for seven doses (a minimum of 5weekly chemotherapy). Patients assigned to AFRT arm will undergo radiation similarly one fraction per day and then the sixth fraction will be given on another day (Saturday) or as an extra fraction on one of the first five days, but always allowing at least a 6-hour interval between fractions on same day. If any unintended interruption of the treatment occurs, this missing treatment will be given as soon as possible, preferably within a week, but not allowing more than 14 Gy to be given during any 7-day period.
16213150|NCT01291069|Drug|Tadalafil Citrate|If allocated to the treatment arm, the patient will be given tadalfil citrate, 0.8-1 mg/kg/day in 1 daily dose. Maximum dose 40 mg. All patients will receive either study drug or placebo for a total of 20 days.
16213151|NCT01291069|Drug|Sugar pill|If allocated to the placebo arm, the child will be given a similar appearing medication; the placebo will be a mixture of Ora-Sweet® and Ora-Plus® in a 1:1 ratio. All patients will receive drug for 20 days
16213152|NCT01291056|Other|Placebo|Each participant will take assigned medication (clomiphene citrate 50mg or placebo) on days 3-7 of her menstrual cycle.
16213153|NCT01291056|Drug|Clomiphene|Each participant will take assigned medication (clomiphene citrate 50mg or placebo) on days 3-7 of her menstrual cycle.
16213154|NCT01291043|Other|Shiatsu|8-week treatment with two Shiatsu sessions per week (50-minute duration)
16213155|NCT01291030|Dietary Supplement|magnesium supplementation|The supplementation starts with 450 mg of magnesium oxide daily, up to a maximum of 3 times 450 mg daily, while aiming at a serum magnesium level of > 1,9 mg/dl.
16213156|NCT01291017|Drug|PD0332991|PD0332991 125 mg PO days 1 - 21
16213157|NCT01291004|Drug|Desogestrel/ethinyl estradiol and ethinyl estradiol|Desogestrel/ethinyl estradiol 0.15/0.02 mg and ethinyl estradiol 0.01 mg tablet
16213158|NCT01291004|Drug|28-day drospirenone oral contraceptive|Drospirenone/ethinyl estradiol 0.3/0.02 mg
16213159|NCT01291004|Drug|28-day levonorgestrel oral contraceptive|Levonorgestrel/ethinyl estradiol 0.1/0.02 mg
16213160|NCT01290991|Device|Augment Bone Graft|Augment Bone Graft physically fills bone defects by providing a biocompatible scaffold for new bone formation.The material is comprised of a matrix of beta tricalcium phosphate and a highly purified recombinant human platelet-derived growth factor.
16213161|NCT01290978|Drug|ChloraPrep|The application sites (subjects' backs) will be prepped with ChloraPrep according to manufacturer's instruction. Samples of 3 surgical incise drapes will be applied to the prepped sites according to randomization schedule
16213162|NCT01290978|Drug|DuraPrep|The application sites (subjects' backs) will be prepped with DuraPrep according to manufacturer's instruction. Samples of 3 surgical incise drapes will be applied to the prepped sites according to randomization schedule
16213163|NCT01290965|Drug|Placebo|Oral tablet given once or three times daily for 15 consecutive days
16213164|NCT01290965|Drug|SCY-635|oral capsule
16213165|NCT01290952|Procedure|Off-pump bypass surgery|is a method of performing a coronary bypass operation for the purpose of treating advanced coronary heart disease while the heart is still beating normally.
16213166|NCT01290952|Procedure|On-pump bypass surgery|is a technique that temporarily takes over the function of the heart and lungs during surgery, maintaining the circulation of blood and the oxygen content of the body.
16213167|NCT01290939|Biological|bevacizumab|
16213168|NCT01290939|Drug|lomustine|
16213169|NCT01290939|Genetic|DNA methylation analysis|
16213170|NCT01290939|Other|laboratory biomarker analysis|
16213171|NCT01290939|Procedure|cognitive assessment|
16213172|NCT01290939|Procedure|quality-of-life assessment|
16213173|NCT01290926|Drug|chemotherapy|sorafenib 600mg/day capecitabine 1250 mg/m²/day
16213174|NCT01290913|Drug|Omalizumab|Omalizumab is an antibody that helps decrease allergic responses in the body
16213175|NCT01290900|Drug|NXL104|IV Solution
16213176|NCT01290900|Drug|Ceftaroline|IV Solution
16213177|NCT01290900|Drug|Placebo Infusion|IV Saline
16213178|NCT01290900|Drug|Ceftazidime|IV Solution
16213179|NCT01290900|Drug|Moxifloxacin|Tablet (1)
16213180|NCT01290887|Drug|Reslizumab|Reslizumab (3.0 mg/kg) administered intravenously by infusion every 28 days (±7 days), for approximately 24 months
16213181|NCT01290874|Drug|Tiotropium|Tiotropium bromide 18 mcg once daily for one year of treatment.
16213182|NCT01290874|Drug|Salmeterol|Salmeterol 50 mcg twice daily for one year of treatment.
16213183|NCT01290874|Drug|Formoterol|Formoterol 12 mcg twice daily for one year
16213184|NCT01290848|Behavioral|Take TIME Health Campaign|"Provision of free, family-based events, at least twice per month, that offer opportunities for physical activity and/or healthy eating in a safe, tobacco-free environment.
~Information dissemination, via project web site, media and other formats, on how to achieve a healthier lifestyle with the already hectic family schedules.
~Adoption of guidelines by community organizations and the Township of Uxbridge that will reduce tobacco exposure, increase safety and promote physical activity and healthy eating for young children."
16213185|NCT01290835|Radiation|Stereotactic radiotherapy delivered by CyberKnife|Adjuvant radiotherapy will be delivered using CyberKnife radiotherapy using twice daily sessions for five days for a total of ten sessions.
16213186|NCT01290835|Radiation|stereotactic radiotherapy|
16213187|NCT01290822|Device|BiVP|Biventricular pacing
16213188|NCT01290822|Device|AAI Pacing|Atrial pacing
16213189|NCT01290796|Device|Ajust Adjustable Single-Incision Sling|The Ajust™ Adjustable Single-Incision Sling is a minimally invasive suburethral sling indicated for the treatment of female SUI resulting from urethral hypermobility and/or intrinsic sphincter deficiency (ISD). The system consists of a unique adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for securing the mesh sling after adjustment.
16213190|NCT01290783|Drug|Irintoecan|"Irinotecan, 180 mg/m2 IV, over 90 minutes, day 1 (in patients > 75 years of age, the irinotecan dose in must be reduced to 150 mg/m2).
~Leucovorin, 400 mg/m2, or levoleucovorin, 200 mg/m2, IV over 90 minutes with irinotecan.
~5-FU, 400 mg/m2 IV bolus day 1, then 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46-48 hours) continuous infusion.
~Repeat every two weeks.
~8 months of treatment."
16213194|NCT01290757|Drug|Dabigatran etexilate|150 mg Qualicaps (R)
16213195|NCT01290744|Drug|Clofazimine|Clofazimine 100mg daily for 12 months after completion of MDT.
16213196|NCT01290744|Drug|Placebo|Daily for 12 months
16213197|NCT01290731|Drug|TMC435|100-mg capsule once daily for 12 weeks
16213198|NCT01290731|Drug|Pegylated interferon (pegIFN alpha-2a)|180 mcg injected subcutaneously (by a syringe under the skin) once weekly for 12 to 36 weeks (or until Week 48).
16213199|NCT01290731|Drug|Ribavirin (RBV)|200-mg tablets (daily dose: 600-1000 mg) taken orally (by mouth) two times a day for 12 to 36 weeks (or until Week 48).
16213200|NCT01290718|Drug|capecitabine [Xeloda]|900mg/m2 bid po on days 1-14 of each 3-week cycle
16213201|NCT01290718|Drug|trastuzumab [Herceptin]|8mg/kg iv on day 1 of the first 3-week cycle, followed by 6mg/kg iv every 3 weeks
16213202|NCT01290705|Behavioral|High exercise therapy|
16213203|NCT01290705|Behavioral|Low exercise therapy|
16213204|NCT01290692|Biological|TVI-Brain-1|Following surgery, tumor tissue is used to generate a cancer vaccine. Patients are vaccinated with neutralized cells to initiate an immune response. Following vaccinations, the patient's white blood cells are collected, the white blood cells are stimulated and expanded, and are then reinfused into the patient's blood.
16213205|NCT01290679|Drug|Placebo|150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a or peginterferon alfa-2b and ribavirin for 48 weeks
16213206|NCT01290679|Drug|TMC435|150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a or peginterferon alfa-2b and ribavirin for 24 or 48 weeks
16213207|NCT01290679|Drug|Peginterferon alpha-2a or Peginterferon alpha-2b (PegIFNα-2a/b)|One subcutaneous (under the skin) injection of PegIFNα-2a (containing 0.5 mL solution with 180 mcg PegIFNα-2a) OR PegIFNα-2b (0.5 mL from a pre-filled pen) once weekly for up to 48 weeks.
16213208|NCT01290679|Drug|Ribavirin (RBV)|200-mg tablets of ribavirin (Copegus or Rebetol) (body-weight adjusted dose) taken orally (by mouth) twice daily for up to 48 weeks.
16213209|NCT01290666|Device|Fistula Plug|Bioabsorbable fistula plug
16213210|NCT01290653|Other|Dry needling|Deep dry needling until achieving twitch response of the muscle
16213211|NCT01290653|Other|Strain-counterstrain technique|A manual technique to release tension of painful muscles.
16213212|NCT01290653|Other|Placebo manual technique|A placebo technique, consisting of manual contact of the therapist with the patient without any further therapeutic approach
16213213|NCT01290640|Device|DePuy fixed-bearing Total Condylar III (TC3) TKA|
16213214|NCT01290640|Device|DePuy PFC Rotating Platform TC3 TKA|
16213215|NCT01290627|Device|Subjects implanted with DePuy LCS PS RP TKA|Subjects implanted with DePuy Low Contact Stress (LCS) Poster Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
16213216|NCT01290627|Device|Subjects implanted with DePuy Sigma PS RP TKA|Subjects implanted with a DePuy Sigma Posterior Stabilizing (PS) Rotating Platform (RP) Total Knee Arthroplasty (TKA)
16213217|NCT01290614|Other|Pharmacist based QI program|Per a study protocol, the pharmacist will call each subject (who has not opted out) and discuss their CKD. In brief, the pharmacist will introduce themselves, ask the subject if they have time to discuss their medical care, inform the subject that they have CKD, briefly discuss CKD, ask the subject if they can come for labs, discuss hypertension management as appropriate, and answer any questions. In addition, for subjects with poorly controlled hypertension, the study pharmacist will arrange for a nutrition consult for a low sodium diet, a mainstay of hypertension management in patients with CKD. Finally, for patients with advanced CKD (GFR <30 mL/min per 1.73 m2) who are not seeing a nephrologist, the study pharmacist will arrange for a nephrology outpatient appointment to assess the need for placement of access for renal replacement therapy.
16213218|NCT01290614|Other|Usual Care|"Patients in the control arm will continue to receive usual care from their VA providers."
16213219|NCT01290601|Drug|Tafenoquine|Tafenoquine: 2 capsules (200mg base/capsule for a total of 400mg base) and 4 chloroquine placebo capsules for 2 days, followed by 2 tafenoquine capsules and 2 chloroquine placebo capsules for 1 day, followed by 1 primaquine placebo capsule/day for 14 days.
16213220|NCT01290601|Drug|Chloroquine + Primaquine|Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 2 day, followed by chloroquine (500 mg chloroquine phosphate) and tafenoquine placebo x 1day, followed by primaquine, 15 mg/day for 14 days.
16213221|NCT01290601|Drug|tafenoquine|Tafenoquine (600 mg base) and chloroquine placebo x 1d, chloroquine placebo x 2 days, followed by primaquine placebo for 14 days.
16213222|NCT01290601|Drug|Chloroquine + Primaquine|Chloroquine (1000 mg chloroquine phosphate) and tafenoquine placebo x 1 day, followed by chloroquine (1000 mg chloroquine phosphate) x 1 day, followed by chloroquine (500 mg chloroquine phosphate) x 1day, followed by primaquine, 15 mg/day for 14 days.
16213223|NCT01290575|Drug|Placebo|capsule, Oral, 0.0mg, twice daily, 14 day
16213224|NCT01290575|Drug|Placebo|Capsule, Oral, 0.0mg, once daily, 14 day
16213225|NCT01290575|Drug|BMS-820132|Capsule, Oral, 15mg, twice daily, 14 day
16213226|NCT01290575|Drug|BMS-820132|Capsule, Oral, 60mg, twice daily, 14 day
16213227|NCT01290575|Drug|BMS-820132|Capsule, oral, 150mg, twice daily, 14 day
16213228|NCT01290575|Drug|BMS-820132|Capsule, Oral, 300mg, twice daily, 14 day
16213229|NCT01290575|Drug|BMS-820132|Capsule, Oral, 450mg, twice daily, 14 day
16213230|NCT01290575|Drug|BMS-820132|Capsule, Oral, To be determined (TBD), once daily, 14 day
16213231|NCT01290575|Drug|BMS-820132|Capsule, Oral, 5 mg, twice daily, 14 day
16213232|NCT01290562|Radiation|Stereotactic Body Radiotherapy (SBRT)|One or more high dose(s) of radiation to treat the tumour.
16213233|NCT01290549|Drug|Polatuzumab Vedotin|Participants will receive escalating intravenous dose of polatuzumab vedotin.
16213234|NCT01290549|Drug|Rituximab|Rituximab will be administered by an IV infusion at 375 mg/m^2 body surface area dose q3w.
16213235|NCT01290536|Device|Selective internal radiation therapy to the liver using Yttrium-90 glass microspheres (TheraSphere)|Administration of Yttrium-90 glass microspheres (TheraSphere) into the hepatic artery
16213236|NCT01290523|Device|Selective internal radiation therapy of the liver with Yttrium-90 glass microspheres (TheraSphere)|Administration of Yttrium-90 TheraSphere glass microspheres into the hepatic artery
16213237|NCT01290510|Device|hyaluronic acid sodium salt|Two injections of 2 % (40 milligrams (mg) / 2 millilitres (ml)) hyaluronan in weekly interval.
16213284|NCT01290211|Drug|Fosamprenavir/ritonavir|fosamprenavir/ritonavir 700/100 mg BID x 10 days
16213238|NCT01290497|Drug|Hyaluronic acid 5 x 2.5 ml|5 intraarticular administration of Adant® 2.5ml with one week interval between administrations (standard treatment)
16213239|NCT01290497|Drug|Hyaluronic acid 1 x 5 ml|1 intraarticular administration of Adant® 5ml
16213240|NCT01290497|Drug|Hyaluronic acid 2 x 5 ml|2 intraarticular administration of Adant® 5ml with a two-week interval between administrations.
16213241|NCT01290484|Drug|Sildenafil|Sildenafil oral tablet three times daily
16213242|NCT01290471|Drug|U3-1565|U3 1565 will be provided as a sterile, frozen solution. Each glass vial will contain 1.1 mL (1 mL extractable) of study medication with a concentration of 100 mg/mL. U3 1565 will be diluted in a final volume of 100 mL and administered by continuous IV infusion over 60 minutes. Infusion times can be extended to a maximum of 120 minutes for subjects unable to tolerate the 60 minute infusion.
16213243|NCT01290458|Dietary Supplement|Antioxidant vitamins|Oral supplementation with one tablet of 1 g of vitamin C (Lamberts Healthcare Ltd, UK) and one tablet of 400 IU of vitamin E (Lamberts Healthcare Ltd, UK)
16213244|NCT01290445|Drug|varenicline|This is a non-interventional study. Exposure in utero to varenicline is observed, not assigned.
16213245|NCT01290445|Behavioral|cigarette smoke from maternal smoking|This is a non-interventional study. Exposure in utero to cigarette smoke from maternal smoking is observed, not assigned.
16213246|NCT01290445|Other|Non-Exposure|This is a non-interventional study. Non-exposure in utero to varenicline and cigarette smoke from maternal smoking is observed, not assigned.
16213247|NCT01290432|Dietary Supplement|Inofolic Plus|Inofolic Plus contains folic acid and myoinositol and melatonin
16213248|NCT01290419|Biological|RSV-F Particle Vaccine|Dose 1 + adjuvant / dose; Day 0 and Day 30
16213249|NCT01290419|Biological|RSV-F Particle Vaccine|Dose 2 + adjuvant / dose; Day 0 and Day 30
16213250|NCT01290419|Biological|RSV-F Particle Vaccine|Dose 3 + adjuvant / dose; Day 0 and Day 30
16213251|NCT01290419|Biological|RSV-F Particle Vaccine|Dose 3 / dose; Day 0 and Day 30
16213252|NCT01290419|Biological|Placebo|Placebo; Day 0 and Day 30
16213253|NCT01290419|Biological|RSV-F Particle Vaccine|Dose 4 / dose; Day 0 and Day 30
16213254|NCT01290419|Biological|RSV-F Particle Vaccine|Dose 4 + adjuvant / dose; Day 0 and Day 30
16213255|NCT01290406|Drug|BEZ235|
16213256|NCT01290393|Other|Data collection|Data collection from hard copy interview forms routinely used by the Organization of Teratology Information Specialists (OTIS).
16213257|NCT01290380|Drug|ASA404, DMXAA, DXAA|ASA404 (5,6-dimethylxantheone-4-acetic acid) DMXAA or DXAA
16213258|NCT01290367|Biological|Single Dose MPCs Injection|Injection of Low Dose MPCs with Hyaluronic Acid into the degenerated lumbar disc's nucleus pulposus.
16213259|NCT01290367|Procedure|Single injection of saline solution|Intradiscal control injection with saline solution
16213260|NCT01290367|Procedure|Single injection of hyaluronic acid|Intradiscal control injection with hyaluronic acid
16213261|NCT01290367|Biological|Single Dose MPCs Injection|Injection of HighDose MPCs with Hyaluronic Acid into the degenerated lumbar disc's nucleus pulposus.
16213262|NCT01290354|Drug|Lapatinib|Unlabelled, administered orally
16213263|NCT01290354|Drug|[11C] lapatinib|Radiolabelled, administered intravenously
16213264|NCT01290341|Drug|NAFT-600 (naftin 2 % gel)|Topical; applied once daily for two weeks
16213265|NCT01290341|Drug|Placebo|Topical; applied once daily for two weeks.
16213266|NCT01290328|Drug|Epoetin Alfa|150 units/kg/weekly
16213267|NCT01290315|Drug|Ferric Carboxymaltose (FCM)|One 500 mg dose at 100 mg/minute (Cohort I) or 750 mg dose at 100 mg/minute (Cohort II)
16213268|NCT01290315|Drug|Iron Sucrose / Iron Dextran|One 500 mg dose of IV iron sucrose administered over 4 hours (Cohort I), or a 750 mg dose of IV iron dextran administered as a 25 mg test dose over 5 minutes followed by a 725 mg dose over 3 hours if no adverse reaction to test dose is observed after 60 minutes (Cohort II)
16213269|NCT01290302|Drug|Luitpold Azacitidine|Subcutaneous (SC) at a dose of 75 mg/m2 per day on days 1 and 2 of a treatment cycle
16213270|NCT01290302|Drug|Vidaza®|Subcutaneous (SC) at a dose of 75 mg/m2 per day on days 1 and 2 of a treatment cycle
16213271|NCT01290289|Other|Epidura, CSE & IV|"Gp 1: received CSE analgesia: 25µg of fentanyl & a bolus dose of 10 ml of 0.5% lidocaine was injected epidurally. E top-ups of 5-10 ml of 0.5-0.8% lidocaine were then injected.
~Gp 2: received CSE analgesia: 25µg of fentanyl & a bolus dose of 10 ml of 0.0625% bupivacaine was injected epidurally. E top-ups of 5-10 ml of 0.0625-0.25% bupivacaine were then injected.
~Gp 3: received 50µg of E fentanyl analgesia & a bolus of 10 ml of 0.5% lidocaine was administered, followed by lidocaine E top-ups of 5-10 ml of 0.5-0.8%.
~Gp 4: received analgesia: 50µg of E fentanyl & a bolus dose of 10 ml of 0.125% bupivacaine was administered, followed by E bupivacaine top-ups of 5-10 ml of 0.125-0.25%.
~Gp 5: 50mg of IV pethidine was administered as loading dose, followed by 0.5 mg/kg."
16213272|NCT01290276|Drug|Ond-PR1|Single oral dose of 8 mg of ondansetron pulsatile-release formulation 1 (Ond-PR1)
16213273|NCT01290276|Drug|Ond-PR1 + MPh-IR|Single oral dose of 8 mg of ondansetron pulsatile-release formulation 1 (Ond-PR1) plus 10 mg methylphenidate immediate release (Mph-IR)
16213274|NCT01290276|Drug|Ond-PR2|Single oral dose of 8 mg ondansetron pulsatile-release formulation 2 (Ond-PR2)
16213275|NCT01290276|Drug|Ond-PR2 +_ MPh-IR|Single oral dose of 8 mg of ondansetron pulsatile-release formulation 2 (Ond-PR2) plus 10 mg methylphenidate immediate release (Mph-IR)
16213276|NCT01290263|Drug|Amgen 386|"For Cohort A, AMG 386 will be administered intravenously at 30 mg/kg every week.
~For Cohort B Phase I, AMG 386 will be administered intravenously at beginning at starting dose level of 15 mg/kg every week.
~For Cohort B Phase II, AMG 386 will be administered intravenously at the maximum tolerated dose determined in the Phase I portion of the study every week."
16213277|NCT01290263|Drug|Bevacizumab|The dose of bevacizumab will be 10 mg/kg and will be administered intravenously every other week.
16213278|NCT01290250|Other|Orange juice based beverage enriched in polyphenols|2 daily doses (250 ml each) during 3 months
16213279|NCT01290237|Drug|vancomycin hydrocloride|see description of study arms
16213280|NCT01290224|Other|scrambler therapy|Undergo MC5-A therapy
16213281|NCT01290224|Procedure|sham intervention|Undergo sham procedure
16213282|NCT01290224|Other|questionnaire administration|Ancillary studies
16213283|NCT01290211|Drug|Maraviroc|maraviroc 300 mg BID x 5 days
16213285|NCT01290211|Drug|Maraviroc + Fosamprenavir/ritonavir|maraviroc 300 mg BID + fosamprenavir/ritonavir 700/100 mg BID x 10 days
16213286|NCT01290211|Drug|Maraviroc|maraviroc 300 mg QD x 5 days
16213287|NCT01290211|Drug|Fosamprenavir/ritonavir|fosamprenavir/ritonavir 1400/100 mg QD x 10 days
16213288|NCT01290211|Drug|Maraviroc + Fosamprenavir/ritonavir|maraviroc 300 mg QD + fosamprenavir/ritonavir 1400/100 mg QD x 10 days
16213289|NCT01290198|Drug|Microdialysis of fluconazole, vehicle and N(G)-nitro-L-arginine-methyl ester (L-NMMA)|At the first three visits, volunteers will receive fluconazole (650µmol/L and 6.5mmol/L) and vehicle (NaCl 0.9%), and at the fourth, these plus L-NMMA (10mmol/L), delivered by microdialysis in the forearm, with or without anesthesia. Then post-occlusive hyperemia and thermal hyperemia are performed.
16213290|NCT01290185|Device|Placement of different catheters for continuous nerve block|Placement different catheters adjacent to the femoral
16213291|NCT01290172|Drug|Administration of Somatostatin|"6 mg will be diluted in saline in a 60 cc syringe to be infused over 24 h (250 mcg/h). The treatment will be started during the hepatectomy phase, after 1st measurement of native arterial and portal flow and pressure and given a clinically significant portal hypertension (CSPH) with a hepatic venous pressure gradient (HVPG) >= 10 mmHg.
~5 cc will be injected in 2 minutes as a single bolus of 500 mcg. Somatostatin will be given a second time at the beginning of the warm ischemia time as a continuous infusion of 250 mcg/h(infusion rate 2,5 cc/h). This will allow the time needed for reaching a stable plasma concentration at reperfusion and minimizing risks of secondary effects. After portal revascularization of the liver graft, a new measurement of portal flow and pressure will be performed. Provided a portal vein flow (PVF) >= 90 ml/min * 100 g LW, the remaining 55 cc will be infused for the following 22 h. 6 mg per day of continuous infusion will be continued for 5 days."
16213292|NCT01290172|Drug|Administration of placebo|"The placebo treatment will be started during the hepatectomy phase, after the 1st measurement of native arterial and portal flow and pressure and given a clinically significant portal hypertension (CSPH) with a hepatic venous pressure gradient (HVPG) >= 10 mmHg.
~5 cc of the 60 cc solution will be injected in 2 minutes as a single bolus of 500 mcg. The placebo will be given a 2nd time at the beginning of the warm ischemia time as a continuous infusion of 250 mcg/h (infusion rate 2,5 cc/h). This will allow the time needed for reaching a stable plasma concentration at reperfusion and minimizing risks of secondary effects. After portal revascularization of the liver graft, a new measurement of portal flow and pressure will be performed. Provided a portal vein flow (PVF) >= 90 ml/min * 100 gram LW, the remaining 55 cc will be infused for the following 22 h. 6 mg per day of continuous infusion will be continued everyday to complete 5 days of therapy."
16213293|NCT01290159|Other|heat tolerance test (HTT)|An exercise-heat test,which consists of 120 min exposure to walking on a treadmill (5km/h; 2% grade) under conditions of 40oC and 50% rh.
16213294|NCT01290146|Drug|Diuretics|Patients randomized to diuretics receive a 24-hour diuretic infusion with a maximum cumulative dose up to 200 mg furosemide/24 h
16213295|NCT01290146|Drug|Levosimendan|"Patients randomized to Levosimendan receive a 24-hour levosimendan infusion with NO prior bolus injection.
~Starting doses will be based on baseline SBP levels
~SBP ≥ 85-99mmHg: 0.05 mcg/kg/min
~SBP ≥100 mmHg: 0.1 mcg/kg/min"
16213296|NCT01290133|Drug|GW597599|Single dose IV infusion
16213297|NCT01290133|Drug|Placebo|Single dose IV infusion
16213298|NCT01290120|Drug|Chemotherapy-Rituximab combination|Short cycles of high-dose and conventional chemotherapy in combination with rituximab, followed by local radiotherapy in the case of initial mediastinal or central nervous system (CNS) involvement or a residual tumor after chemotherapy. Used drugs are rituximab,cyclophosphamide, prednisone, dexamethasone, vincristine, methotrexate, iphosphamide, teniposide, etoposide, dexamethasone, cytarabine,adriamycin, vincristine, vindesine.
16213299|NCT01290107|Genetic|DNA analysis|
16213300|NCT01290107|Genetic|gene rearrangement analysis|
16213301|NCT01290107|Genetic|microarray analysis|
16213302|NCT01290107|Genetic|polymerase chain reaction|
16213303|NCT01290107|Other|immunological diagnostic method|
16213304|NCT01290107|Other|laboratory biomarker analysis|
16213305|NCT01290094|Drug|ibandronate [Bonviva/Boniva]|3 mg intravenously every 3 months
16213306|NCT01290081|Other|Case management approach in referral to health care services|Case management intervention aimed at increasing TB screening and treatment entry among injecting drug users referred from a methadone drug treatment program
16213307|NCT01290068|Device|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL|Multifocal IOL with extended secondary focal point implanted for long-term use over the lifetime of the cataract patient
16213308|NCT01290068|Device|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL|Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
16213309|NCT01290068|Device|Monofocal IOL|Monofocal IOL implanted for long-term use over the lifetime of the cataract patient
16213312|NCT01290042|Drug|AMG 181|Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.
16213313|NCT01290042|Other|Placebo for AMG 181|Four escalating dose levels of AMG 181 administered as multiple doses of AMG 181 in healthy subjects, in subjects with active ulcerative colitis, and in subjects with active Crohn's disease.
16213314|NCT01290029|Drug|Cinacalcet|Single, oral dose of 0.25 mg/kg cinacalcet
16213315|NCT01290016|Behavioral|2 servings dairy + exercise|Subjects in this group will receive family based counseling to maintain the intake of 2 servings of dairy per day and also receive instruction on how to improve their physical activity.
16213316|NCT01290016|Behavioral|4 servings dairy + exercise|Subjects in this group will receive family based counseling to increase intake of dairy to 4 servings per day and also receive instruction on how to improve their physical activity.
16213317|NCT01290016|Behavioral|Control|The group will receive information during the study about diet and exercise but will not receive the intervention until 6 months into the study protocol.
16213318|NCT01290003|Drug|Piperacillin-Tazobactam and Amikacin|Inj Piperacillin-Tazobactam 50 mg/Kg/dose 12 hourly IV X 3 days (6 doses) Inj Amikacin 15 mg/kg/dose 24 hourly IV X 3 days (3 doses)
16213319|NCT01289990|Drug|BI 10773|BI 10773 tablets once daily
16213320|NCT01289990|Drug|Placebo|Placebo matching BI 10773 low dose
16213321|NCT01289990|Drug|Placebo|Placebo matching BI 10773 high dose
16213322|NCT01289990|Drug|Placebo|Placebo matching Sitagliptin
16213323|NCT01289990|Drug|Placebo|Placebo matching BI 10773 high dose
16213324|NCT01289990|Drug|Placebo|Placebo matching BI 10773 high dose
16213325|NCT01289990|Drug|BI 10773|BI 10773 tablets once daily
16213326|NCT01289990|Drug|Placebo|Placebo matching BI 10773 low dose
16213327|NCT01289990|Drug|Placebo|Placebo matching BI 10773 low dose
16213328|NCT01289990|Drug|BI 10773|BI 10773 tablets once daily
16213329|NCT01289990|Drug|Placebo|Placebo matching BI 10773 low dose
16213330|NCT01289990|Drug|Placebo|Placebo matching BI 10773 high dose
16213331|NCT01289990|Drug|Placebo|Placebo matching Sitagliptin
16213332|NCT01289990|Drug|BI 10773|BI 10773 tablets once daily
16213333|NCT01289990|Drug|BI 10773|BI 10773 tablets once daily
16213334|NCT01289990|Drug|BI 10773|BI 10773 tablets once daily
16213335|NCT01289990|Drug|Placebo|Placebo matching BI 10773 high dose
16213336|NCT01289990|Drug|BI 10773|BI 10773 tablets once daily
16213337|NCT01289990|Drug|Placebo|Placebo matching BI 10773 low dose
16213338|NCT01289990|Drug|Placebo|Placebo matching BI 10773 high dose
16213339|NCT01289990|Drug|Placebo|Placebo matching Sitagliptin
16213340|NCT01289990|Drug|Sitagliptin 100mg|Sitagliptin once daily
16213341|NCT01289990|Drug|BI 10773|BI 10773 tablets once daily
16213342|NCT01289990|Drug|Placebo|Placebo matching BI 10773 low dose
16213343|NCT01289990|Drug|Placebo|Placebo matching BI 10773 low dose
16213344|NCT01289990|Drug|Placebo|Placebo matching BI 10773 low dose
16213345|NCT01289990|Drug|Placebo|Placebo matching BI 10773 high dose
16213346|NCT01289990|Drug|Placebo|Placebo matching BI 10773 low dose
16213347|NCT01289990|Drug|Placebo|Placebo matching BI 10773 high dose
16213348|NCT01289990|Drug|Placebo|Placebo matching BI 10773 high dose
16213349|NCT01289964|Procedure|Dry Cupping or fire cupping|5 dry cupping treatments, application twice a week, non standardised procedure
16213350|NCT01289951|Drug|Raltegravir 400 mg/12hours|
16213351|NCT01289951|Drug|Raltegravir 400 mg/12hours|
16213352|NCT01289938|Drug|Diphenhydramine|Diphenhydramine 50 mg oral once
16213353|NCT01289938|Drug|Metoclopramide|10 mg i.v. metoclopramide once
16213354|NCT01289925|Dietary Supplement|Selenium|200 micrograms of selenium (in the form of selenium methionine) in tablet form taken orally daily for 8 weeks. Capsule molds with inert coating.
16213355|NCT01289925|Other|Sugar Pill Placebo|Placebo supplements in the same capsule mold as selenium and coated with the same inert coating. 1 tablet daily for 8 weeks.
16213356|NCT01289912|Drug|RAD001|"RAD001 is formulated as tablets of 5.0 mg strength, blister-packed under aluminum foil in units of 10 tablets and dosed on a regular basis. RAD001 tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
~Patients will be instructed to take 4.5 mg/m2 of RAD001 orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast."
16213357|NCT01289912|Drug|Placebo|"Matching placebo will be provided as a matching tablet and will also be blister packed under aluminum foil in units of 10. Matching placebo tablets should be opened only at the time of administration as drug is both hygroscopic and light-sensitive.
~Patients will be instructed to take 4.5 mg/m2 of the matching placebo orally with a glass of water at regular intervals at the same time in the morning after a light, nonfat breakfast."
16213358|NCT01289899|Drug|BR-A-657|120, 360mg or placebo 7days
16213359|NCT01289886|Drug|BR-A-657|20, 60, 120, 240, 360, 480mg or placebo tablet
16213360|NCT01289860|Dietary Supplement|Flavonoids|475g of anthocyanidins in 300ml of blueberry drink.
16213361|NCT01289860|Dietary Supplement|Control|29g powder: sugars (glucose, sucrose, fructose), vitamin C and citric acid.
16213362|NCT01289847|Biological|Gammaplex|GAMMAPLEX 5g/100 mL, dose is 300-800 mg/kg/infusion every 21 or 28 days, intravenously. The total duration of treatment with GAMMAPLEX will be 12 months with a 3 month follow-up.
16213363|NCT01289834|Device|Hi-Fatigue Bone Cement|"Hi-Fatigue bone cement is a new development of Aap Biomaterials, GmbH & Co that has not yet been tested in the clinical setting. Hi-Fatigue has a medium to low viscosity. Laboratory tests confirm Hi-Fatigue bone cement to have properties equivalent to or better than the golden standard bone cement Palacos. Hi-Fatigue is to be used without pre-chilling. When mixed at a room temperature of 21°C Hi-Fatigue has a low initial viscosity improving mixing and theoretically reducing the porosity of the cured cement."
16213364|NCT01289834|Device|Palacos Bone Cement|"Palacos Bone Cement has been used for 48 years and has a good reputation as the gold standard among bone cements (3). It is a high-viscosity cement with rapid application that makes it advantageous for use in orthopedic joint surgery. Palacos cement was developed in order to allow hand mixing of monomers and polymers in a dish in the operating room. Air pollution with toxic monomers in the operating room was a problem that was primarily solved by exhaust ventilation, later supplemented with vacuum mixing"
16213365|NCT01289821|Drug|Regorafenib (Stivarga, BAY73-4506)|Subjects will receive regorafenib 160 mg od on days 4 to 10 and days 18 to 24 as four 40 mg coprecipitate tablets. In case of administration as a single agent during the study, regorafenib will be administered 160 mg od for 3 weeks on/1 week off. Each cycle consists of 28 days.
16213366|NCT01289821|Drug|Oxaliplatin|On day 1 and day 15 of each cycle, participants will receive 85 mg/m^2 oxaliplatin as a 2 hour i.v. infusion.
16213367|NCT01289821|Drug|Folinic acid|On day 1 and day 15 of each cycle, participants will receive folinic acid (either 400 mg/m^2 D/L-folinic acid or 200 mg/m^2 L-folinic acid) as a 2 hour i.v. infusion.
16213368|NCT01289821|Drug|5-FU (mFOLFOX6)|Participants will receive a 400 mg/m^2 5 FU i.v. bolus injection immediately followed by a 2400 mg/m^2 5 FU 46 hour i.v. infusion.
16213371|NCT01289782|Drug|Placebo|150 mg capsule once daily for 12 weeks in addition to PegIFN alpha-2a and RBV for 48 weeks
16213372|NCT01289782|Drug|TMC435|150 mg capsule once daily for 12 weeks in addition to PegIFN alpha-2a and RBV for 24 or 48 weeks
16213373|NCT01289782|Drug|Peginterferon alpha-2a (PegIFN alpha-2a)|One subcutaneous (under the skin) injection containing 0.5 mL solution with 180 mcg PegIFN alpha-2a once weekly for up to 48 weeks.
16213374|NCT01289782|Drug|Ribavirin (RBV)|200-mg tablets of RBV (body-weight adjusted dose) taken orally (by mouth) twice daily for up to 48 weeks.
16213375|NCT01289769|Drug|Dexmedetomidine|dexmedetomidine 0.7 microgram per kilogram in saline 20 ml given within 10 minutes before intubation
16213376|NCT01289769|Drug|Placebo|normal saline 20 ml( the same volume as dexmedetomidine) giving within 10 minutes.
16213377|NCT01289756|Drug|Clomiphene|clomiphene once 100 mg oral
16213378|NCT01289756|Drug|clomiphene and paroxetine|clomiphene 100mg and paroxetine 3x40mg
16213379|NCT01289756|Drug|clomiphene and clarithromycin|clomiphene 100mg and clarithromycin 9x500mg
16213380|NCT01289743|Drug|Etanercept|Etanercept 25 mg subcutaneously twice a week
16213381|NCT01289730|Drug|Etanercept|Etanercept 25 mg subcutaneously twice a week
16213382|NCT01289704|Other|TreSPE|"treadmill: 5'warm up, 20'aerobic exercise (gradually incremented to 30', from session to session, if possible), 5'warm down, controlling hearth rate, blood pressure and SaO2.
~Respiratory Physiotherapy: positive Expiratory Pressure (PEP) bottle for 10' (in various postures), and postural training, for the other 10'.
~Stretching for 20', of the triceps surae, tibialis posterior, extensor and flexors digitorum longus and brevis, both at the bed and in a static position.
~Proprioceptive and postural kinesitherapy according to the Perfetti method.
~Balance Exercising consists of exercises carried on by basculating bars with improving difficulties in the instruments utilized and in the tasks with therapist supervision and near a handbar preventing falls."
16213383|NCT01289704|Other|SPE|"Respiratory Physiotherapy for 20', consisting of Positive Expiratory Pressure (PEP) bottle for 10' (in various postures), and postural training according to the Mèzières technique, for the other 10'.
~Stretching for 20', of the triceps surae, tibialis posterior, extensor and flexors longus and brevis, both at the bed and in a static position.
~Proprioceptive and postural kinesitherapy according to the neurocognitive method.
~Balance Exercising consists of exercises carried on by moving bars with improving difficulties in the instruments utilized and in the tasks with therapist supervision and near a handlebar preventing falls."
16213384|NCT01289691|Other|One Lung Ventilation|Patients in this group will be ventilated with a mixture of air and oxygen during one lung ventilation.
16213385|NCT01289691|Other|One Lung Ventilation|Patients in this group will be ventilated with only oxygen during one lung ventilation.
16213386|NCT01289678|Drug|Interleukin-2|Famotine 20mg IV push daily just prior to the aldesleukin (IL-2) IL-2 18 million IU/m2 in 50 mL 5% D5 or NS IVPB over 15 - 30 minutes daily for 5 days
16213387|NCT01289665|Procedure|Lubricating gel used during speculum insertion.|Examiner will use 0.5 mL of sterile lubricating gel to lubricate standard-sized plastic speculum during clinically indicated vaginal speculum examination. Patients will mark visual analog scale immediately following insertion.
16213388|NCT01289665|Procedure|Water used during speculum examination.|Patients will under vaginal speculum examination using 3 mL of water as a lubricant and will mark a visual analog scale immediately after speculum insertion.
16213389|NCT01289639|Drug|fenofibrate|micronized fenofibrate 200 mg 1 po qd
16213390|NCT01289639|Drug|pioglitazone|pioglitazone 30 mg po qd
16213391|NCT01289639|Drug|placebo|placebo 1 capsule po qd
16213392|NCT01289626|Drug|lanthanum carbonate|FOSRENOL® will be administered orally in a dose of 1500- 3750 mg daily in divided doses with meals. Dose escalation will be utilized to a target dose of 3750 mg daily or as designated by clinician over a 4-week period from start of study. The drug will be administered for 12 weeks.
16213393|NCT01289626|Drug|Lanthanum for calciphylaxis|Lanthanum use in calciphylaxis
16213394|NCT01289600|Device|Mechanical ventilation|The mechanical ventilator is set to different ventilation modes as described in the individual arms.
16213395|NCT01289587|Behavioral|Physical activity intervention|36 sessions of physical activity offered at different frequencies
16213396|NCT01289574|Drug|ASC-J9|Cream for twice daily topical application to the face
16213397|NCT01289561|Drug|Alcohol + Caffeine Beverage|14 g alcohol per 180 ml total beverage combined with 60 mg caffeine per 180 ml total beverage. The alcohol and caffeine will be mixed in a fruit punch beverage. Participants may self-administer as much beverage as they like with several constraints to assure safety (e.g., participants must stop drinking if their blood alcohol content is above .12 g/dl).
16213398|NCT01289561|Drug|Alcohol + Caffeine-placebo|14 g alcohol per 180 ml total beverage combined with 2.2 mg quinine per 180 ml total beverage. The alcohol and quinine will be mixed in a fruit punch beverage. Participants may self-administer as much beverage as they like with several constraints to assure safety (e.g., participants must stop drinking if their blood alcohol content is above .12 g/dl).
16213399|NCT01289548|Device|remote ischaemic preconditioning|Remote ischaemic preconditioning consisted of three 5-min cycles of left lower limb ischaemia, which was induced by an automated cuff-inflator placed on the left lower limb and inflated to 300 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated.
16213400|NCT01289535|Procedure|Blood sample|Blood sample of 7 ml
16213401|NCT01289522|Biological|cetuximab IV|"Cetuximab 400 mg/m² over 120 minutes on day 1 of cycle 1 only.
~Cetuximab dose will be 250 mg/m² IV over 60 minutes weekly on subsequent administrations during the four cycles of chemotherapy.
~Cetuximab dose will be 500mg/m2 IV every 2 weeks during the maintenance therapy.
~Drug: Cisplatin IV : 75 mg/m2 intravenous every 3 weeks for 4 cycles
~Drug: Docetaxel IV : 75 mg/m2 intravenous every 3 weeks for 4 cycles
~G-CSF support with lenograstim 150 microg./m2/day is delivered after each cycle of chemotherapy."
16213402|NCT01289522|Other|Biopsies|No intervention, only biopsy for translational project.
16213403|NCT01289509|Drug|E5501|Lot P01010ZZA (test) single oral doses of 40 mg tablets.
16213404|NCT01289509|Drug|Drug: E5501|Lot P97001ZZB (reference) single oral doses of 40 mg tablets.
16213435|NCT01289275|Behavioral|Brief Hospital Counseling|All subjects receive bedside counseling either from Respiratory Therapists or nurses according to the hospital's particular practices.
16213436|NCT01289262|Procedure|Purse string closure technique|Uterine incision will be closed with purse string closure technique.
16213405|NCT01289496|Drug|Peg-interferon alpha-2a, Ribavirin|"4 weeks RBV priming;
~24 or 48 weeks of Pegasys+Ribavirin (RBV) Treatment (depending on genotype);
~24 weeks Follow-Up
~Patients will receive PEGASYS® 180 µg in 0.5 mL (prefilled syringes) administered sc once weekly. Specific guidelines for adjusting the dose of PEGASYS® are provided in the product monograph.All PEGASYS® administrations will be via the sc route using sterile technique.
~Ribavirin 200 mg tablets"
16213406|NCT01289483|Drug|fospropofol|After the initial bolus dose of study drug is given, a maximum of two supplemental doses of fospropofol at 25% of the initial dose will be permitted. Fospropofol supplements will be administered every 4 min
16213407|NCT01289483|Drug|fospropofol|After the initial bolus dose of study drug is given, a maximum of two supplemental doses of fospropofol at 25% of the initial dose will be permitted. Fospropofol supplements will be administered every 4 min
16213408|NCT01289483|Drug|fospropofol|After the initial bolus dose of study drug is given, a maximum of two supplemental doses of fospropofol at 25% of the initial dose will be permitted. Fospropofol supplements will be administered every 4 min
16213409|NCT01289483|Drug|fospropofol|After the initial bolus dose of study drug is given, a maximum of two supplemental doses of fospropofol at 25% of the initial dose will be permitted. Fospropofol supplements will be administered every 4 min
16213410|NCT01289457|Drug|Clofarabine|"Phase I: 15 mg/m2 by vein (IV) daily for 5 days of a 28 day cycle.
~Phase II: Clofarabine (dose selected based on Phase I portion) by vein over approximately 1 hour daily for 5 days (days 1-5) for a 28 day cycle."
16213411|NCT01289457|Drug|Idarubicin|10 mg/m2 by vein over approximately 30 minutes daily for 3 days (days 1-3) of a 28 day cycle.
16213412|NCT01289457|Drug|Cytarabine|1 g/m2 by vein over approximately 2 hours daily for 5 days (days 1-5) for a 28 day cycle.
16213413|NCT01289457|Drug|Fludarabine|30 mg/m2 by vein over approximately 30 minutes daily for 5 days (days 1-5).
16213414|NCT01289444|Behavioral|FAmily CEntered (FACE) ACP|Three-60 to 90 minute sessions scheduled one week apart: 1) To assess values, spiritual and other beliefs, and life experiences with illness and EOL care & when to initiate advance care planning. 2) To facilitate conversations and shared decision-making between the adolescent and guardian/surrogate about palliative care & prepare the surrogate to be able to fully represent the adolescent's wishes. 3) Which person the teen wants to make health care decisions for him/her; The kind of medical treatment the teen wants; How comfortable the teen wants to be; How the teen wants people to treat him/her; What teen wants loved ones to know; Any spiritual or religious concerns teens may have.
16213415|NCT01289444|Behavioral|Healthy Living Control|"Active Comparator: Three 60 to 90 minute sessions scheduled one week apart. 1. Developmental History. Goal: To take a non-medical developmental history. The RA-Control will conduct the session in a structured interview format. Administered with all medical questions removed to prevent any risk of contamination with the experimental condition. 2. Safety Tips. Goal: To provide safety information using the American Academy of Pediatrics Bright Futures counseling guides. Participants will be asked questions about seat belt use, etc. Safety information will be provided.
~3. Nutrition Tips. Goal: To provide safety information using the American Academy of Pediatrics Bright Futures nutrition/counseling guides."
16213416|NCT01289431|Drug|Mapracorat|administered daily to each eye for 2 weeks following allergen challenge using a CAC model
16213417|NCT01289431|Drug|Vehicle|administered daily to each eye for 2 weeks following allergen challenge using a CAC model
16213418|NCT01289405|Device|Continuous Positive Airway Pressure (CPAP)|mechanical splint to open airway during sleep, considered the gold standard treatment for patients with obstructive sleep apnea
16213419|NCT01289392|Device|Continuous Positive Airway Pressure (CPAP)|Previously determinated airway pressure: used for two months unassociated with physical exercise and used for four months associated with physical exercise
16213420|NCT01289392|Device|Oral Appliance (OA)|Anterior mandibular repositioner: used for two months unassociated with physical exercise and used for four months associated with physical exercise
16213421|NCT01289392|Behavioral|Physical Exercise|aerobic and resistance Physical exercise, three times a week, for four months
16213422|NCT01289379|Procedure|High Frequency Jet Ventilation|
16213423|NCT01289379|Procedure|HFJV|
16213424|NCT01289366|Device|Endocytoscopy|Patients with Crohn's disease and ulcerative colitis who underwent colonoscopy are prospectively included in this study. Methylene blue or toluidine blue is topically applied to enable EC (XEC-120-U, Olympus, Tokyo, Japan). Data are digitally saved and analyzed independently from each other by two gastroenterologists and one pathologist who are blinded to clinical and endoscopic data.
16213425|NCT01289353|Drug|Carboplatin|IV, weekly for 6 weeks, AUC of 2.0
16213426|NCT01289353|Radiation|3D-RT or IMRT|"From week 2 to week 4 in the 6-week Carboplatin treatment:
~Whole Breast 3D-RT or IMRT at 2.7 Gy X 15 fractions (5 times/wk x 3 wks=40.50 Gy), then the second and third Friday, 3 Gy to the tumor bed only X 2 fractions, Total dose to tumor bed = 46.5 Gy"
16213427|NCT01289327|Drug|Sedation with Propofol or Midazolam+Alfentanil for FFB|Sedation was started with intravenous injection of a bolus of 2-4 mg midazolam and 0.5 mg alfentanil or 20-50 mg propofol. It was maintained with intermittent boluses of 1-3 mg intravenous midazolam or 0.5 mg intravenous alfentanil, according to clinical judgment, or with boluses of 10-20 mg intravenous propofol, administered at short intervals (~2 minutes) or according to clinical judgment.
16213428|NCT01289314|Procedure|TLH|Total laparoscopic hysterectomy (TLH)
16213429|NCT01289314|Procedure|Laparoscopic supracervical hysterectomy|Laparoscopic supracervical hysterectomy (LSH)
16213430|NCT01289301|Drug|mTOR inhibitor (everolimus)|calcineurin-inhibitor based immunosuppression will be switched to immunosuppression based on m-TOR inhibitor (everolimus trough level 3-7ng/mL)
16213431|NCT01289301|Drug|cyclosporine or tacrolimus|calcineurin inhibitor (cyclosporine or tacrolimus) will be continued (trough level 60-90ng/mL resp 3-7ng/mL)
16213432|NCT01289288|Behavioral|Mailed printed materials and in-office training|"Mailed printed materials including CRC physician guide, patient brochure, flip chart and a poster
~Two sessions of in-office training with two standardized patients"
16213433|NCT01289275|Drug|Nicotine Patches|Subjects randomized into the patch condition will receive 8 weeks of nicotine patches at discharge. The kit will contain 4 weeks of 21mg patches, 2 weeks of 14mg, and 2 weeks of 7mg.
16213434|NCT01289275|Behavioral|Telephone Counseling|Up to 5 proactive counseling sessions from California Smokers' Helpline.
16213485|NCT01288885|Drug|ASP1941|Oral
16213486|NCT01288885|Drug|Placebo|Oral
16213437|NCT01289262|Procedure|Continuously locked closure technique|Uterine incision will be closed with continuously locked closure technique
16213438|NCT01289236|Drug|milnacipran|1 tablet (50mg) BID (twice daily, approximately 12 hours apart) for 12 weeks after appropriate titration period
16213439|NCT01289236|Drug|Milnacipran|1 tablet (100mg) BID (twice daily, approximately 12 hours apart)for 12 weeks after appropriate titration period.
16213440|NCT01289236|Drug|Placebo|1 tablet (placebo) BID (twice daily, approximately 12 hours apart) for 12 weeks after appropriate titration period.
16213441|NCT01289223|Drug|Bendamustine IV|
16213442|NCT01289223|Other|Treatment of Physicians Choice|Defined as any cancer specific therapy or best supportive care. Treatment should be given according to the label and based upon local institutional medical practice and clinical judgement.
16213443|NCT01289210|Drug|VTX-2337 plus radiotherapy|Radiation on Day 1. On Day 2, VTX-2337 3.0mg/m2 is administered intratumorally, followed by radiation. VTX-2337 3.0mg/m2 is then given weekly for 3 weeks in a 4 week cycle over 3 cycles.
16213444|NCT01289197|Behavioral|Family Check Up|Families in the intervention condition will be contacted by the parent consultant following the T1 and T2 assessments and be invited to participate in the Family Check-Up (FCU). The FCU intervention involves at least three sessions in which we expect both mother and child to participate in. First is the in-home family assessment. The second session involves rapport-building via an initial interview with the caregiver(s), referred to as the Get-to-Know-You visit, or for families already enrolled in an ongoing study, a Check-Back-In visit. The third is a Feedback Session during which the results of the assessment and initial interview are discussed with the caregiver, with attention focused on the caregiver's and child's readiness to change and the delineation of specific change options.
16213445|NCT01289171|Drug|Glycolic acid|Those who met the study criteria commenced once daily use of 15% glycolic acid lotion to the face and/or dorsal hands, with an increase to twice daily application as tolerated after two weeks of use.
16213446|NCT01289145|Behavioral|Motivational intervention|The motivational intervention promotes positive outcome expectancies on physical activity.
16213447|NCT01289145|Behavioral|Volitional intervention|The volitional intervention promotes the formulation of action plans for physical activity.
16213448|NCT01289145|Behavioral|Active Control|Participants receive a quiz on physical activity and sports.
16213449|NCT01289132|Drug|Placebo|Placebo-matching tablets, orally, once daily for up to 12 weeks.
16213450|NCT01289132|Drug|Azilsartan|Azilsartan 5 mg, tablets, orally, once daily for up to 12 weeks.
16213451|NCT01289132|Drug|Azilsartan|Azilsartan 10 mg, tablets, orally, once daily for up to 12 weeks.
16213452|NCT01289132|Drug|Azilsartan|Azilsartan 20 mg, tablets, orally, once daily for up to 12 weeks.
16213453|NCT01289132|Drug|Azilsartan|Azilsartan 40 mg, tablets, orally, once daily for up to 12 weeks.
16213454|NCT01289132|Drug|Azilsartan|Azilsartan 80 mg, tablets, orally, once daily for up to 12 weeks.
16213455|NCT01289132|Drug|Candesartan cilexetil|Candesartan cilexetil 8 mg, tablets, orally, once daily for 4 weeks; titrated to 12 mg, tablets, orally, once daily for up to 8 weeks.
16213456|NCT01289119|Drug|Alogliptin|Alogliptin tablets
16213457|NCT01289119|Drug|Placebo to alogliptin|Alogliptin placebo-matching tablets.
16213458|NCT01289119|Drug|Metformin|Stable metformin dose
16213459|NCT01289119|Drug|Pioglitazone|Stable pioglitazone dose
16213460|NCT01289106|Biological|Hepavax-Gene|20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1 and 6 months
16213461|NCT01289106|Biological|Hepavax-Gene|20 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months
16213462|NCT01289106|Biological|Hepavax-Gene|40 μg of Hepavax-gene intramuscularly injections at deltoid region at 0,1,2 and 6 months
16213463|NCT01289080|Drug|OPC-34712|administered orally
16213464|NCT01289067|Drug|Satraplatin|Satraplatin 80mg/m2 day 1-5 every 35 days Prednisone 5 mg twice daily every 35 days
16213465|NCT01289054|Drug|Tasigna|
16213466|NCT01289054|Drug|Gleevec|
16213467|NCT01289041|Drug|BKM120|
16213468|NCT01289028|Drug|Nilotinib|
16213469|NCT01289015|Drug|NAFT-600 ( naftin 2 % gel )|Topical; applied once daily for two weeks
16213470|NCT01289015|Drug|Placebo|Topical; applied once daily for two weeks
16213471|NCT01288989|Biological|IMC-3C5|Escalating doses of IMC-3C5 administered intravenously (i.v.), weekly or every other week
16213472|NCT01288976|Device|MitraClip|The MitraClip System includes a MitraClip device, a Steerable Guide Catheter, and a MitraClip Delivery System that enables placement of the MitraClip device on the mitral valve leaflets
16213473|NCT01288976|Drug|Medical Management|The Non-Surgical Medically Managed Heart Failure (HF) Group consists of patients with mitral regurgitation (MR) in whom the MR is managed non-surgically based on standard hospital clinical practice. Patients with MR who receive a pacemaker, Implantable Cardiac Defibrillator (ICD) and/or Cardiac Resynchronization Therapy (CRT) treatments may be included
16213474|NCT01288976|Procedure|Mitral Valve Surgery|The Mitral Valve Surgery Group consists of patients with MR in whom the MR is managed surgically (repair or replacement) based on standard hospital clinical practice. Patients with concurrent coronary artery bypass grafting (CABG) or aortic/tricuspid valve or and other cardiac procedure except atrial fibrillation surgery are excluded.
16213475|NCT01288963|Drug|IL-2|Observation only
16213476|NCT01288950|Dietary Supplement|Vitamin D3 (cholecalciferol)|A single oral dose of 50,000 IU of vitamin D3 (cholecalciferol) will be given prior to Bacille-Calmette-Guerin (BCG) vaccination
16213477|NCT01288937|Drug|Milnacipran|"Patients will be randomly assigned to receive milnacipran 100 mg/day (including a 1 week dose titration period):
~Day 1: 12.5 mg once Day 2, 3: 25 mg/day (12.5 mg twice daily) Day 4, 7: 50 mg/day (25 mg twice daily) After Day 7: 100 mg/day (50 mg twice daily)"
16213478|NCT01288937|Drug|Placebo|Patients will be randomly assigned to placebo for 9 weeks (including a 1 week dose titration period), matching the schedule of the study drug.
16213479|NCT01288924|Drug|Parecoxib|Parecoxib 40 mg intravenous before surgery and every 12 hours for two days.
16213480|NCT01288924|Other|Control|NSS 2 ml intravenous before surgery and every 12 hours for two days.
16213481|NCT01288911|Drug|enzalutamide|capsules
16213482|NCT01288911|Drug|bicalutamide|tablets
16213483|NCT01288898|Drug|ASP1941|Oral
16213484|NCT01288898|Drug|Placebo|Oral
16213487|NCT01288872|Drug|Praziquantel|Praziquantel (PZQ), 60 mg/kg, administered orally in split dose (30 mg/kg each dose) separated by three hours.
16213488|NCT01288859|Other|free curcumin|free curcumin in bread, dosage 1g/100g, 200g/day per 1 day
16213489|NCT01288859|Other|encapsulated curcumin|encapsulated curcumin-enriched bread, 1g/100g bread, 200g bread/day
16213490|NCT01288859|Other|encapsulated curcumin + PQG|bread enriched with encapsulated curcumin plus piperine, quercetin and genistein, 1g/100g bread, 200g bread/day
16213491|NCT01288859|Other|free cocoa polyphenol|nut cream enriched with free cocoa polyphenols, 1,5 g/100g cream, 100g/day per 1 day
16213492|NCT01288859|Other|encapsulated cocoa polyphenols|nut cream enriched with encapsulated cocoa polyphenols, 1,5 g/100g cream, 100g/day per 1 day
16213493|NCT01288859|Other|control nut cream|nut cream, cocoa polyphenols 0g/100g cream, 100 g/day per 1 day
16213494|NCT01288833|Device|Close focus HD NBI Colonoscopy System|Technically improved colonoscope with close focus high definition narrow band imaging. Optical specifications include a 2mm near field focal depth.
16213495|NCT01288820|Drug|Dihydroartemisinin/piperaquine + primaquine|Dihydroartemisinin 2.25mg/kg and piperaquine 16-18mg/kg on day 0, 1, and 2 and primaquine 15 mg/kg form day 0-13.
16213496|NCT01288820|Drug|Artesunate-amodiaquine + primaquine|Standard treatment with artesunate-amodiaquine plus primaquine, with artesunate 4mg/kg and amodiaquine 10mg/kg on day 0, 1, and 2 and primaquine 15 mg/kg form day 0-13.
16213497|NCT01288807|Drug|Milnacipram|Titration to 200mg PO daily
16213498|NCT01288794|Drug|Diuretics plus human albumin|The patients will receive standard medical treatment plus albumin infusion at the dose of 40 g twice weekly for 2 weeks, and then 40 g weekly for the rest of the study (up to 24 months).
16213499|NCT01288794|Drug|Diuretics (standard medical treatment)|The patients will receive standard medical treatment (diuretics)
16213500|NCT01288781|Drug|Acetazolamide|During a forty eight hour hypoxic exposure (3777m), subjects will be given either acetazolamide or placebo at hours fifteen, twenty and thirty two.
16213501|NCT01288781|Drug|Lactose monohydrate|During a forty eight hour hypoxic exposure (3777m), subjects will be given either acetazolamide or placebo at hours fifteen, twenty and thirty two.
16213502|NCT01288768|Procedure|Knee arthroscopy|Knee arthroscopy within 4 weeks.
16213503|NCT01288755|Drug|TMC278|One 25 mg tablet, once daily, for 11 days (TrtA and C)
16213504|NCT01288755|Drug|Raltegravir|One 400 mg tablet, twice daily, for 4 days (Trt B) and for 11 days (TrtC)
16213505|NCT01288742|Drug|Rosuvastatin|One 10-mg tablet for 1 day (Trt C).
16213506|NCT01288742|Drug|Rosuvastatin|One 10-mg tablet together with 1 capsule of TMC435 (150 mg) on Day 7 of Trt D.
16213507|NCT01288742|Drug|TMC435|One 150-mg capsule once daily for 7 days (Trts B and D).
16213508|NCT01288742|Drug|Digoxin|One 0.25-mg tablet together with 1 capsule of TMC435 (150 mg) on Day 7 of Trt B.
16213509|NCT01288742|Drug|Digoxin|One 0.25-mg tablet for 1 day (Trt A)
16213510|NCT01288729|Device|Sure-T Steel Infusion Set Catheter|Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time
16213511|NCT01288729|Device|Quick-Set Teflon Catheter|Participants will wear Quick-Set Teflon Catheter or Sure-T Steel Infusion Set Catheter for 2 weeks each during the active study time
16213512|NCT01288716|Drug|Arbaclofen|
16213513|NCT01288690|Behavioral|Narrative Exposure Therapy|3, 1-1/2 hour sessions, individual, meeting weekly.
16213514|NCT01288677|Drug|TMC649128|Escalated doses
16213515|NCT01288664|Drug|ADVAGRAF|Tacrolimus Sustained-release Capsules (ADVAGRAF) Started: 0.05-0.1mg/kg/d, one time per day, the blood level:5-10ng/ml in induction phase.
16213516|NCT01288651|Drug|Ferricarboxymaltose|"Ferricarboxymaltose (Ferinject®, Vifor Pharma) is used for intravenous iron administration. This iron is administered in high dose iron infusion of 1000 mg iron (equals 20 ml Ferinject) in 250 ml saline in the vein (infusion site)within 2 hours. During infusion, patients will be observed and blood pressure and heart rate are monitored before and after administration.
~Four weeks after iron administration, iron parameters are measured in the general practitioners setting. When iron parameters are still under normal values, a repeat infusion will be given of 500 mg iron (equals 10 ml Ferinject)."
16213517|NCT01288638|Other|Pulse-based diet|The pulse based-diet will include meals prepared with dry peas, lentils, chickpeas, and beans. Two meals will be supplied daily for 16 weeks to those participants on the pulse-based diet program. Meals will contain approximately 90g dried peas, 225 g chickpeas or beans, or 150g lentils.
16213518|NCT01288638|Other|TLC diet|Grocery gift cards will be provided weekly for 16 weeks to those participants in the placebo group. Recipe booklet will be given to follow Therapeutic Lifestyle Changes (TLC) guidelines, recommended by National Cholesterol Education Program (NCEP) and will be based on lean-meats for the protein source. The recipes will exclude pulses.
16213519|NCT01288625|Drug|Amifostine|500 mg sc, qod, 3 times per week
16213520|NCT01288625|Radiation|Amifostine|500mg rinsing wash, qod, 3 times per week
16213521|NCT01288612|Device|Sedated Endoscopy|The sedated esophagogastroduodenoscopy procedures were performed using a conventional high-definition endoscope (GIF-180, Olympus America, Center Valley, Pennsylvania) under conscious sedation with intravenous midazolam and fentanyl.
16213522|NCT01288612|Device|Transnasal Endoscopy|Unsedated transnasal endoscopy performed using the EndoSheath transnasal esophagoscope (TNL-5000, Vision Sciences). Topical anesthetic aerosol spray was applied to the posterior pharynx and nasal spray mixture was applied to the patients nares 10-15 minutes before the endoscopy procedure.
16213523|NCT01288599|Procedure|Laparoscopic surgery|Laparoscopic surgery where adnexectomy or cystectomy is performed.
16213524|NCT01288586|Device|Scandinavian Total Ankle Replacement System (STAR Ankle)|Total Ankle Replacement
16213525|NCT01288573|Drug|plerixafor|160 μg/kg subcutaneous (SC) injection
16213526|NCT01288573|Drug|plerixafor|240 μg/kg subcutaneous (SC) injection
16213527|NCT01288573|Drug|plerixafor|320 μg/kg subcutaneous (SC) injection
16213528|NCT01288560|Other|Advanced cardiac imaging|
16213529|NCT01288560|Other|Standard Cardiac Imaging|
16213530|NCT01288547|Dietary Supplement|theobromine|700 mg theobromine in gelatin capsules given one time only
16213531|NCT01288547|Dietary Supplement|Caffeine|120 mg caffeine in capsules given one time only
16214050|NCT01284504|Other|placebo|Placebo, tab
16213532|NCT01288547|Dietary Supplement|caffeine + theobromine|120 mg caffeine and 700 mg theobromine in capsules given one time only
16213533|NCT01288547|Dietary Supplement|placebo|cellulose in capsules given one time only
16213534|NCT01288534|Radiation|Radiation Therapy|Patients will receive 5 fractions of radiation (you will not receive radiation therapy on two consecutive days). Each fraction size will be 7.4 Gy. The total dose will be 37 Gy. The 5 treatments will be scheduled to be delivered 2 fractions per business week (Monday through Friday). The total duration of treatment will be no shorter than 15 days and no longer than 19 days.
16213535|NCT01288521|Drug|Tacrolimus + Ketoconazole, Then Tacrolimus alone|Pharmacokinetic profiling of tacrolimus (AUC0-24h) in subjects receiving tacrolimus + ketoconazole 200 mg every 12 hours x 3 doses.
16213536|NCT01288521|Drug|Tacrolimus alone, Then Tacrolimus + Ketoconazole|Pharmacokinetic profiling of subjects on a stable dose of tacrolimus (AUC 0-24h)
16213537|NCT01288508|Dietary Supplement|Supra Fiber|2 tablespoons of fiber taken with 8oz water taken twice a day for 30 days
16213538|NCT01288508|Dietary Supplement|Psyllium|1 tablespoon of fiber taken with 8 oz water twice a day for 30 days
16213539|NCT01288495|Dietary Supplement|supplemental L-alanine|Subjects will consume l-alanine prior to eating fructose-containing foods.
16213540|NCT01288495|Dietary Supplement|Metamucil|Subjects will consume the placebo prior to eating fructose-containing foods.
16213541|NCT01288482|Device|AeroEclipse II breath-actuated nebulizer|The AeroEclipse II (Trudell Medicinal International, London, ON, Canada) is a breath-actuated nebulizer that allows for the creation of aerosol only in response to the patient's inspiratory flow, resulting in virtually no drug loss to the environment and providing a safer healthcare and patient environment by significantly reducing second-hand drug exposure and the possibility for transmission of viral airborne pathogens.
16213542|NCT01288482|Device|English-Wright continuous-mode nebulizer|The English-Wright is a continuous-mode nebulizer, designed to operate continuously with tidal breathing, producing an aerosol which is lost to the environment possibly posing a hazard to any fellow-patients, family members, or health-care workers in the vicinity. It is the only device recommended by the American Thoracic Society guidelines that is available on the market and it has recently been discontinued. For these reasons it is necessary to review the use of other nebulizers and validate their performance.
16213543|NCT01288469|Drug|Alirocumab|One subcutaneous (SC) injection in the abdomen only.
16213544|NCT01288469|Drug|Placebo (for alirocumab)|One SC injection in the abdomen only.
16213545|NCT01288469|Drug|Atorvastatin|Over-encapsulated tablet orally once daily in the evening with dinner.
16213546|NCT01288469|Drug|Placebo (for atorvastatin)|One over-encapsulated tablet of placebo for atorvastatin orally once daily in the evening with dinner.
16213547|NCT01288443|Drug|Alirocumab|Two SC injections in the abdomen only.
16213548|NCT01288443|Drug|Placebo (for alirocumab)|Two subcutaneous (SC) injections in the abdomen only.
16213549|NCT01288443|Drug|Atorvastatin|Orally once daily at a stable dose of 10 mg, 20 mg, or 40 mg as background therapy.
16213550|NCT01288430|Drug|DS-2248|Oral capsules, of various strengths (1, 5 , 20 ,or 50 milligrams), once daily during 21-day cycles, until unacceptable treatment-related toxicity or tumor progression are observed.
16213551|NCT01288417|Drug|boceprevir|10 days of boceprevir 800mg TID
16213552|NCT01288417|Drug|raltegravir|raltegravir 400mg single dose
16213553|NCT01288404|Drug|Fluorometholone|topical 0.1% fluorometholone eye drops 4 times daily for 4 weeks
16213554|NCT01288404|Drug|Bevacizumab|subconjunctival bevacizumab 1.25 mg/0.05mL
16213555|NCT01288404|Drug|Bevacizumab|subconjunctival bevacizumab 2.5 mg/0.1mL
16213556|NCT01288404|Drug|Bevacizumab|subconjunctival bevacizumab 3.75 mg/0.15mL
16213557|NCT01288391|Drug|NNC 0128-0000-2011|Single dose of 100 mcg/kg NNC128-0000-2011 administered i.v. (intravenously)
16213558|NCT01288391|Drug|NNC 0128-0000-2011|Single dose of 200 mcg/kg NNC128-0000-2011 administered i.v. (intravenously)
16213559|NCT01288378|Drug|caspofungin acetate|intravenous route, at a 70 mg loading dose on day 1 of antifungal therapy, followed by 50 mg once a day thereafter.
16213560|NCT01288365|Behavioral|Exercise training|Exercise training program for 3 months (two times a week).
16213561|NCT01288352|Other|early standardised rhythm control|"Patients in the early therapy group will be treated following the same therapeutic recommendations of the ESC guidelines as the usual care group. In addition, rhythm control therapy will be initiated early with the aim of preventing recurrence and delaying or preventing progression of AF.
~Early-onset rhythm control therapy can consist of:
~Optimal antiarrhythmic drug therapy
~Catheter ablation with the aim of pulmonary vein isolation (PVI),
~Antiarrhythmic drug therapy and catheter ablation may be combined and supplemented by early cardioversion in patients with persistent AF.
~All individual treatment decisions will be taken by the treating study physician considering the labelling of the procedures and drugs and patient preferences."
16213562|NCT01288339|Drug|Panitumumab + FOLFOX (DP)|Panitumumab and FOLFOX will be administered to patients with DP once every 14 days until 6 months of treatment or until disease progression (PD) or unacceptable toxicity. If patients have not progressed after 6 months of treatment with panitumumab and FOLFOX they will continue with panitumumab monotherapy until disease progression.
16213563|NCT01288339|Drug|Panitumumab + FOLFOX (no-DP)|Panitumumab and FOLFOX will be administered to patients with no-DP (MMP7+/p-IGF-IR-, MMP7-/p-IGF-IR+ or MMP7-/p-IGF-IR) once every 14 days until 6 months of treatment or until disease progression (PD) or unacceptable toxicity. If patients have not progressed after 6 months of treatment with panitumumab and FOLFOX they will continue with panitumumab monotherapy until disease progression.
16213564|NCT01288326|Drug|liraglutide|Liraglutide will be prescribed and titrated (individually adjusted) by the treating physician.
16213565|NCT01288313|Dietary Supplement|nutritional intervention|Each diet will last 30 days. During the first period of 15 days, the mothers will receive mediterranean diet based on olive oil. Then, lactating women will receive 30gr/day rapeseed oil. Human milk will be collected during the first breastfeeding of the day (10 ml) at three times : Days 0 corresponding to the usual diet , at day 15 after the Mediterranean diet and at day 30, after the study diet.
16213603|NCT01288066|Procedure|Hemiarthroplasty|Patients are treated with hemi shoulder arthroplasty with CE marked medical devices of the Epoca system. This procedure is a standard treatment for patients with a degenerative shoulder disease.
16213696|NCT01287390|Other|scoring acute toxicity|Acute toxicity scoring, based on Common Toxicity criteria (CTC) version 2.
16213566|NCT01288313|Dietary Supplement|nutritional intervention|Each diet will last 30 days. During the first period of 15 days, the mothers will receive mediterranean diet based on olive oil. Then, lactating women will receive diet associating 30gr/day of rapeseed oil and n-3 margarine. Human milk will be collected during the first breastfeeding of the day (10 ml) at three times : Days 0 corresponding to the usual diet , at day 15 after the Mediterranean diet and at day 30, after the study diet.
16213567|NCT01288313|Dietary Supplement|nutritional intervention|Each diet will last 30 days. During the first period of 15 days, the mothers will receive mediterranean diet based on olive oil. Then, lactating women will receive with 30gr/day n-3 margarine. Human milk will be collected during the first breastfeeding of the day (10 ml) at three times : Days 0 corresponding to the usual diet , at day 15 after the Mediterranean diet and at day 30, after the study diet.
16213568|NCT01288313|Dietary Supplement|nutritional intervention|Each diet will last 30 days. During the first period of 15 days, the mothers will receive mediterranean diet based on olive oil. Then, lactating women receive 30gr/day olive oil (standard group. Human milk will be collected during the first breastfeeding of the day (10 ml) at three times : Days 0 corresponding to the usual diet , at day 15 after the Mediterranean diet and at day 30, after the study diet.
16213569|NCT01288300|Behavioral|Picture good health/Imaginate una buena salud|Diabetes education, self-empowerment training, exercise, patient navigator
16213570|NCT01288300|Behavioral|Diabetes lecture|Diabetes self-management lecture
16213571|NCT01288274|Other|Community Based administration of DMPA|Injectable contraceptive administered by clinic based health extension worker or community based reproductive health agent using same protocol to test equivalence of community based distribution to facility based distribution
16213572|NCT01288261|Drug|paclitaxel|Given IV
16213573|NCT01288261|Biological|bavituximab|Given IV
16213574|NCT01288261|Other|laboratory biomarker analysis|Correlative studies
16213575|NCT01288261|Other|pharmacological study|Correlative study
16213576|NCT01288248|Device|Airway laryngeal mask classic|"This group includes patients with the randomization process are assigned to use Classic laryngeal mask as a method to secure the airway after induction of anesthesia, which will be maintained during surgery and removed the patient asleep once you are done the surgical procedure to determine the presence or absence of laryngospasm.
~The laryngeal mask mark to be used will laryngeal Mask Device ® which comes in different sizes and sterilized in ethylene oxide. The size of the Classic laryngeal mask is used according to the weight assigned"
16213577|NCT01288248|Device|endotracheal tube|"This group includes patients with the randomization process are allocated to use endotracheal tube method for securing the airway after induction of anesthesia, which will be maintained during surgery and removed in the awake patient when you finish the surgical procedure to determine the presence or absence of laryngospasm.
~The marks of the endotracheal tube will be one of the following: Kendall Curity ®, Well Lead Medical ®, Meditec ®, which are not reusable. The size of the endotracheal tube be allocated according to age."
16213578|NCT01288235|Radiation|Proton radiotherapy|5 days a week
16213579|NCT01288222|Other|KIR genotype|KIR genotype data from unrelated donor are collected
16213580|NCT01288209|Drug|TMC435|100-mg capsule taken by mouth once daily for 12 or 24 weeks.
16213581|NCT01288209|Drug|Peginterferon alfa-2a (PegIFNα-2a )|PegIFNα-2a (PEGASYS) will be administered according to the manufacturer's prescribing information as 180 mcg once weekly injected subcutaneous (under the skin) for up to 24-48 weeks.
16213582|NCT01288209|Drug|Ribavirin (RBV)|RBV (COPEGUS) will be administered according to the manufacturer's prescribing information. If body weight is > 80 kg the total daily dose of RBV will be 1000 mg, taken by mouth as 400 mg (2 tablets of 200 mg) after breakfast and 600 mg (3 tablets of 200 mg) after supper. If body weight is > 60 kg to <=80 kg the total daily dose will be 800 mg, taken by mouth as 400 mg (2 tablets of 200 mg per intake) after breakfast and supper. If body weight is <=60 kg the total daily dose of RBV will be 600 mg, taken by mouth as 200 mg (1 tablet of 200 mg) after breakfast and 400 mg (2 tablets of 200 mg) after supper. Total duration of RBV will be 24-48 weeks.
16213583|NCT01288196|Drug|Placebo IV|A single 30-minute IV infusion of placebo
16213584|NCT01288196|Drug|CNTO 6785 1 mg/kg IV|A single 30-minute IV infusion of CNTO 6785 1 mg/kg
16213585|NCT01288196|Drug|CNTO 6785 3 mg/kg IV|A single 30-minute IV infusion of CNTO 6785 3 mg/kg
16213586|NCT01288196|Drug|CNTO 6785 10 mg/kg IV|A single 30-minute IV infusion of CNTO 6785 10 mg/kg
16213587|NCT01288196|Drug|CNTO 6785 SC|A single SC dose of CNTO 6785 (3 mg/kg) administered in up to 3 SC injections
16213588|NCT01288196|Drug|Placebo SC|A single SC dose of placebo administered in up to 3 SC injections
16213589|NCT01288183|Procedure|sham tDCS|"sham condition as delivered by the stimulator study mode (2mA during 40s and brief current pulses until the end of the stimulation) 20 minutes, 10 sessions, 2 per day"
16213590|NCT01288183|Procedure|active tDCS|anodal tDCS applied over the right DLPFC 2mA, 20minutes, 10 sessions, 2 per day
16213591|NCT01288170|Drug|Nebcinal Tobi|
16213592|NCT01288170|Drug|Tobi Nebcinal|
16213593|NCT01288157|Drug|Golimumab|Single dose of 100 mg subcutaneously
16213594|NCT01288157|Drug|Golimumab|Single dose of 50 mg subcutaneously
16213595|NCT01288144|Other|Quality improvement initiative|In intervention clinics, the LMR will use the existing reminder function to alert providers that a patient has a probable history of gestational diabetes. The provider will then have the opportunity to clarify the subject's history and order appropriate screening testing. Providers will also have access to online reference material regarding GDM follow-up screening and lifestyle interventions.
16213596|NCT01288131|Drug|Cyclosporine combine with mycophenolate mofetil|Cyclosporine 100 mg BID and mycophenolate mofetil 750 mg BID for 24 weeks
16213597|NCT01288131|Drug|Cyclophosphamide + pred|Cyclophosphamide 100 mg QD combine with prednisolon 1.0 mg/kg/day
16213598|NCT01288105|Device|Optical coherence tomography|Optical coherence tomography will be performed to determine the stent strut coverage. Patients in whom >95% of stent struts are covered will not receive perioperative bridging with a glycoprotein IIb/IIIa inhibitors, whereas those with <95% stent strut coverage will receive perioperative bridging.
16213599|NCT01288092|Drug|BEZ235|
16213600|NCT01288079|Drug|TC-5214|Tablet, oral, twice daily for 8 weeks
16213601|NCT01288079|Drug|Duloxetine|Capsule, oral, once daily
16213602|NCT01288079|Drug|Placebo|Tablet, oral, twice daily for 8 weeks
16213604|NCT01288066|Procedure|Total arthroplasty|Patients are treated with total shoulder arthroplasty with CE marked medical devices of the Epoca system. This procedure is a standard treatment for patients with a degenerative shoulder disease.
16213605|NCT01288053|Biological|Allogeneic Stem Cell Therapy|Donor stem cells will be given to subject diagnosed with Crohn's disease
16213606|NCT01288040|Behavioral|Split Belt treadmill|A split belt treadmill is like a typical treadmill that is seen in the gym, except that this treadmill has two belts that move instead of just one. One leg goes on one belt and the other leg uses the other belt. The belt speeds can be set to get at the same speed, making this treadmill similar to any regular treadmill, but, belt speeds can also be set so that one belt moves a little faster than the other. The belts are never set at a running or jogging speed, only a self-paced walking speed regardless of whether the belts are both going the same speed or both going slightly different speeds.
16213607|NCT01288027|Biological|Alglucosidase Alfa|Alglucosidase alfa intravenous infusion 20 milligram per kilogram (mg/kg) every other week for 24 weeks.
16213608|NCT01288001|Drug|Ostenil plus|2% Sodium Hyaluronate plus Mannitol injection
16213609|NCT01287988|Drug|ocriplasmin|Subjects were exposed to a single intravitreal injection of 125µg of ocriplasmin in a previous phase III study TG-MV-006 or TG-MV-007
16213610|NCT01287988|Drug|placebo|Subjects were exposed to a single intravitreal injection of placebo in a previous phase III study TG-MV-006 or TG-MV-007
16213611|NCT01287975|Other|Occupational Therapy|"Use of conventional manual facilitation and function-based training used in conventional occupational therapy training for post-stroke upper limb weakness.
~Training is modelled along the neurodevelopmental techniques and will include stretching, tone management, weight bearing exercises, movement facilitation, selfcare training, arm ergometry by arm bicycles and grip strength training.
~Training intensity is 1.5 hours for 3 times a week for 6 weeks consecutively."
16213612|NCT01287975|Device|BCI Haptic Knob|BCI based robotic rehabilitation works by detecting the motor intent of the user from electroencephalogram signals to drive the robotic rehabilitation via Haptic Knob. Training intensity is 1.5 hours for 3 times a week for 6 weeks consecutively.
16213613|NCT01287975|Device|Haptic Knob|Haptic Knob is an upper limb robot designed for use in robotic-assisted rehabilitation of the stroke wrist and hand. Training intensity is 1.5 hours for 3 times a week for 6 weeks consecutively.
16213614|NCT01287962|Drug|apatinib|750 mg，po，QD； 28 days every cycle
16213615|NCT01287962|Drug|placebo|po，QD； 28 days every cycle
16213616|NCT01287949|Biological|Diphtheria, tetanus, polio and pertussis vaccination|1 dose of REPEVAX (0.5 mL) at Day 0, 1 dose of REVAXIS (0.5 mL) 1 month later and 1 dose of REVAXIS 6 month later
16213617|NCT01287936|Biological|SB623|SB623, a modified stem-cell product, will be administered at 3 dose levels. Each patient in one of three groups will be given a dose of 2.5, 5.0, or 10 million cells once. Each group will be completed before going to the next higher-dose group.
16213618|NCT01287910|Other|Cardiac MRI|Cardiac MRI within 30 days prior to TMR procedure and 6 months after TMR procedure.
16213619|NCT01287897|Drug|PF-04236921 SC injection|Placebo delivered SC, 2 doses separated by 4 weeks
16213620|NCT01287897|Drug|PF-04236921 SC injection|Drug dose level 1 delivered SC, 2 doses separated by 4 weeks
16213621|NCT01287897|Drug|PF-04236921 SC injection|Drug dose level 2 delivered SC, 2 doses separated by 4 weeks
16213622|NCT01287884|Other|Venous Blood Gas|patients who have been identified by the treating physician as needing an ABG will receive an VBG is they consent to take part in the study
16213623|NCT01287858|Drug|AC430|Healthy volunteers will either receive AC430 or placebo.
16213624|NCT01287845|Drug|BAY1075553|Cancer patients, single intravenous bolus injection of 300 MBq BAY1075553 over 60 seconds on the treatment day 1
16213625|NCT01287845|Drug|BAY1075553|Healthy volunteers for dosimetry, single intravenous bolus injection of 300 MBq BAY1075553 over 60 seconds on the treatment day 1
16213626|NCT01287832|Drug|Vancomycin|Vancomycin dosed to achieve a trough of 15-20 microgram/mL.
16213627|NCT01287832|Drug|Daptomycin|
16213628|NCT01287806|Drug|ulinastatin|Resolved 4 vials of drugs in 100ml physiological saline solution,intravenously infused for 1-2h,tid,for continuous 10days
16213629|NCT01287806|Drug|blank group|standard treatment
16213630|NCT01287793|Drug|tigecycline|intravenous, 200 mg, single dose
16213631|NCT01287793|Drug|tigecycline|intravenous, 50 mg, single dose
16213632|NCT01287793|Drug|moxifloxacin|oral tablet, 400 mg, single dose
16213633|NCT01287793|Drug|100 mL 0.9% Sodium Chloride intravenous|intravenous fluid, 100 mL, single dose
16213634|NCT01287793|Drug|placebo|0.9% Sodium Chloride intravenous 100mL, single dose
16213635|NCT01287780|Device|Collagen-gentamicin sponge|A 10 by 10 cm sponge consisting of 280 mg collagen and 130 mg gentamicin.Two sponges are inserted during hemiarthroplasty surgery, one in the joint and one underneath the fascia at the time of surgical closure.
16213636|NCT01287767|Behavioral|A multidimensional support program|Counseling, education and problem-solving in support group, ad hoc counseling
16213637|NCT01287754|Drug|erlotinib [Tarceva]|150 mg daily orally
16213638|NCT01287741|Drug|Rituximab|Rituximab at a dose of 375 mg/m^2, administered by intravenous (IV) infusion on Day 1 of each 21-day cycle for 8 cycles.
16213639|NCT01287741|Drug|Obinutuzumab|Obinutuzumab 1000 mg IV infusion, administered on Day 1 of each 21-day cycle for 8 cycles. During Cycle 1, obinutuzumab was also infused on Days 8 and 15.
16213640|NCT01287741|Drug|Cyclophosphamide|Cyclophosphamide 750 milligrams per square metre (mg/m^2), administered intravenously (IV) on Day 1 of each 21-day cycle.
16213641|NCT01287741|Drug|Doxorubicin|Doxorubicin 50 mg/m^2 IV, administered on Day 1 of each 21-day cycle.
16213642|NCT01287741|Drug|Vincristine|Vincristine 1.4 mg/m^2 (maximum 2 mg) IV, administered on Day 1 of each 21-day cycle.
16213643|NCT01287741|Drug|Prednisone|Prednisone 100 mg (or equivalent prednisolone or methylprednisolone), administered orally on Days 1-5 of each 21-day cycle.
16213644|NCT01287728|Drug|Treatment BY METROMIDAZOLE|Abnormal vaginal flora (a Nugent score of 4-10 or 3 Amsel criteria) will be treated with 2g of oral metronidazole
16213645|NCT01287715|Drug|etanercept|Discontinuation of etanercept (half of the dosis for 3 months and discontinuation thereafter)
16213646|NCT01287715|Drug|etanercept|Continuation of etanercept for another 9 months, and, if still meeting the eligibility criteria, discontinuation of etanercept thereafter.
16213647|NCT01287702|Dietary Supplement|Delayed feeding|patients with acute bleeding varices arrested by EVL, will receive feeding 48 hours after EVL
16213648|NCT01287702|Dietary Supplement|Dealyed feeding|patients with acute bleeding varices arrested by EVL, will receive feeding 48 hours after EVL
16213649|NCT01287702|Dietary Supplement|Early feeding|patients receiving EVL will receive liquid diet since 4 hours after arresting of variceal bleedingpatients with acute bleeding varices arrested by EVL
16213650|NCT01287689|Other|Immunoglobulin G (IgG)|Not applicable. All interventions are at the discretion of the investigator. All marketed IgG formulations can be documented.
16213651|NCT01287663|Drug|Permethrin impregnated|
16213652|NCT01287663|Drug|no Permethrin impregnated|
16213653|NCT01287637|Procedure|Early reversal of temporary ileostomy|Temporary ileostomy is reversed 8-13 days after the primary surgery
16213654|NCT01287637|Procedure|Standard reversal of temporary ileostomy|Patients in the control group will have the ileostomy reversed according to standard treatment, which is 12-26 weeks after primary operation
16213655|NCT01287624|Drug|Gemcitabine,cisplatin|Gemcitabine 1250 mg/m2, IV drip 30 minutes, D1, D8 Cisplatin 75 mg/m2, IV drip 120 minutes, D1
16213656|NCT01287624|Drug|Gemcitabine, Paclitaxel|Gemcitabine 1250 mg/m2, IV drip 30 minutes, D1, D8 Paclitaxel 175 mg/m2, IV, 3h,D1
16213657|NCT01287611|Procedure|Purse string closure technique|Uterine Kerr incision will be closed with purse string suture
16213658|NCT01287611|Procedure|Continuously locked closure technique|Uterine Kerr incision will be closed with continuously locked suturing
16213659|NCT01287598|Drug|Regorafenib (Stivarga, BAY73-4506)|BAY73-4506 administered once a daily (od) in a 21-day on / 7-day off schedule
16213660|NCT01287598|Drug|Warfarin|CYP 2C9 (warfarin) at Cycle 1
16213661|NCT01287598|Drug|Omeprazole|CYP 2C19 (omeprazole) at Cycle 1
16213662|NCT01287598|Drug|Midazolam|CYP 3A4 (midazolam) at Cycle 1
16213663|NCT01287598|Drug|Rosiglitazone|CYP2C8 (rosiglitazone) at Cycle 1
16213664|NCT01287585|Drug|ADI-PEG 20 (arginine deiminase formulated with polyethylene glycol)|18 mg/m2, weekly, intramuscular, until disease progression or toxicity.
16213665|NCT01287585|Drug|Placebo|weekly, intramuscular, until disease progression or toxicity.
16213666|NCT01287585|Other|Best Supportive Care|treatment of disease-related symptoms throughout the study.
16213667|NCT01287546|Drug|LY2875358|Part A Dose escalation of LY2875358 administered intravenously (IV), Day 1 and 15 every 28 days for at least two cycles.
16213668|NCT01287546|Drug|LY2875358 + erlotinib|Part A2 Dose escalation of LY2875358 administered IV, on Day 1 and 15 every 28 days for at least two cycles in combination with daily erlotinib dosing (150 mg) taken orally (PO).
16213669|NCT01287546|Drug|LY2875358 at Part A highest dose|Part B (Dose Exploration): LY2875358 at Part A highest dose administered IV, on Day 1 and 15 every 28 days for at least two cycles.
16213670|NCT01287546|Drug|LY2875358 at Part A highest dose + trametinib|Part B (in combination with trametinib): LY2875358 at Part A highest dose administered IV, on Day 1 and 15 every 28 days for at least two cycles, in combination with trametinib at 2 mg orally once daily
16213671|NCT01287533|Drug|Ibandronate|monthly dosage of ibandronate 150mg
16213672|NCT01287533|Drug|Placebo|monthly dosage of placebo
16213673|NCT01287520|Drug|LY2090314|Administered intravenously
16213674|NCT01287520|Drug|pemetrexed|Administered intravenously
16213675|NCT01287520|Drug|Carboplatin|Administered intravenously
16213676|NCT01287520|Other|ranitidine|Per I2H-MC-JWYA Protocol Amendment (d) approved 11 March 2010, 50 mg ranitidine given as pretreatment to LY2090314 for stomach pain.
16213677|NCT01287507|Dietary Supplement|Lactoferrin (bovine origin)|Bovine lactoferrin 200 mg/daily, given with either human milk or preterm formula
16213678|NCT01287494|Drug|Sertraline|dosage form: Capsule dosage: 50-200mg/d frequency: once per day duration: 16 weeks
16213679|NCT01287481|Behavioral|Stress and Emotions|Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others.
16213680|NCT01287481|Behavioral|Thoughts and Behaviors|Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking.
16213681|NCT01287481|Behavioral|Brain and Body|Focus on the empowering patients by providing the latest scientific information about fibromyalgia, including causes, the role of the nervous system, and various treatments.
16213682|NCT01287455|Drug|"Vitamin D3 as BABY D3"|drops, 70 drops (= 14000 units), once weekly for 6 weeks
16213683|NCT01287455|Other|placebo|drops, 70 placebo drops, once weekly for 6 weeks
16213684|NCT01287442|Procedure|Trabeculectomy|A scleral flap is created. The aqueous humor is so guided under the conjunctiva to lower IOP.
16213685|NCT01287429|Other|lung and pleural ultrasound|After the initial diagnostic work-out (medical history, physical examination, EKG, arterious blood gas), the emergency physician will classify dyspnoea in cardiogenic or respiratory dyspnoea and write it down in a specific form (clinical form). Immediately after this, lung and pleural ultrasound will be performed: the physician will describe it and evaluate the etiology again (integrated evaluation form). Then a chest X-ray evaluation will be performed for each patient.
16213686|NCT01287416|Behavioral|Applied Suicide Intervention Skills Training|Applied Suicide Intervention Skills Training (ASIST) is a 2-day, 14 hour suicide intervention skills training workshop.
16213687|NCT01287416|Behavioral|Resilience Retreat|The Resilience Retreat is a 2-day, 14 hour session
16213688|NCT01287403|Other|Refined wheat flour|A treated cereal flour mixed with milk.
16213689|NCT01287403|Other|Esterase wholegrain wheat flour|A treated cereal flour mixed with milk.
16213690|NCT01287403|Other|Wholegrain wheat flour|A treated cereal flour mixed with milk.
16213691|NCT01287403|Other|Liquid whole grain wheat flour|A treated cereal flour mixed with milk.
16213692|NCT01287403|Other|Wholegrain barley flour|A treated cereal flour mixed with milk.
16213693|NCT01287403|Other|Liquid wholegrain barley flour|A treated cereal flour mixed with milk.
16213694|NCT01287390|Procedure|video fluoroscopy|video fluoroscopy of swallowing function at baseline, 6 months and 12 months follow-up
16213695|NCT01287390|Procedure|extra imaging|For tumor response, 2 extra CT or Fludeoxyglucose (18F)-Positron Emission Tomography (PET)/Computed Tomography (CT), and/or Magnetic Resonance Imaging (MRI) will be performed.
16213697|NCT01287390|Other|scoring of late toxicity|Scoring of late toxicity with the 'late effects in normal tissues subjective, objective, management and analytic'(LENT-SOMA) scale.
16213698|NCT01287390|Other|scoring quality of life (QOL)|Quality of life is scored with the Quality of Life Questionnaire of the 'European Organisation for Research and Treatment of Cancer' (EORTC QOL-C30) and the Head and Neck Cancer Specific Quality of Life Questionnaire (QLQ-H&N 35).
16213699|NCT01287377|Behavioral|Telephone Counseling|Telephone counseling has several distinguishing features, namely proactive follow up counseling calls, a manualized protocol, and relapse-sensitive scheduling. The follow-up call schedule includes a reminder call if the quit date is more than one week out, a call within 24 hours of the quit attempt, another call 4-7 days after the quit date, and another call 10-14 days after the quit date.
16213700|NCT01287377|Drug|Nicotine Patches|"Subjects are randomized into one of these pharmacotherapy interventions: direct mailing of active patches with a message to start using it on their quit date, direct mailing of active patches with a message to start using it right away, or usual care patches in which no patches are sent directly (although clients may still get them through their usual channels).
~For those in the usual care condition, patches will not be mailed directly to them; however, we will facilitate their use by providing a certificate that can be used by the State Medicaid program and some other insurance companies to obtain free patches. For those in the active condition, we will mail 2 weeks of patches directly to their home. All subjects will receive a 2 week starter kit with fourteen 21mg patches."
16213701|NCT01287364|Drug|ciclesonide hydrofluoroalkane (HFA) nasal aerosol|ciclesonide hydrofluoroalkane (HFA) nasal aerosol 80 μg once daily for one week.
16213702|NCT01287364|Drug|mometasone nasal inhalation|mometasone nasal inhalation 200 μg once daily for one week
16213703|NCT01287351|Drug|extra-fine hydrofluoroalkane beclometasone dipropionate|
16213704|NCT01287351|Drug|Fluticasone propionate|
16213705|NCT01287338|Drug|Olopatadine|low dose
16213706|NCT01287338|Drug|Olopatadine|high dose
16213707|NCT01287325|Drug|DNK333 100 mg twice daily|
16213708|NCT01287325|Drug|Placebo|
16213709|NCT01287312|Procedure|Endoscopic repair of recurrent TEF by trichloroacetic acid aplications|
16213710|NCT01287299|Other|Low Glycemic Load diet|Pregnant women were counseled to consume a diet with a glycemic load per 1000 kcal of less than 55.
16213711|NCT01287299|Other|Low Fat Diet|Pregnant women were counseled to consume diets providing less than 25% of the energy as fat.
16213712|NCT01287286|Dietary Supplement|AC-Can|Antrodia cinnamomea compounds of 15 milliliters liquid per pack, oral post meal, twice in a day for 30 days
16213713|NCT01287286|Dietary Supplement|placebo|Placebo of 15 milliliters liquid per pack, oral post meal, twice in a day for 30 days
16213714|NCT01287260|Drug|Nifedipine (Adalat, BAYA1040)|BAYA1040_Nifedipine 40mg twice daily (BID)
16213715|NCT01287260|Drug|Nifedipine (Adalat, BAYA1040)|BAYA1040_Nifedipine 40mg once daily (OD)
16213716|NCT01287247|Biological|Xeomin®|Xeomin® (incobotulinumtoxinA) at a dose determined by the physician based upon his/her clinical experience with botulinum toxin.
16213717|NCT01287234|Other|Echocardiogram/SonR|All patients will have an echocardiograph and SonR sensor readings
16213718|NCT01287221|Drug|Rifampicin|300 mg, 2 times daily
16213719|NCT01287221|Drug|placebo|placebo
16213720|NCT01287208|Device|Activity monitor|The activity monitor is an accelerometer that records steps, distance, calories, and sleep
16213721|NCT01287208|Device|Activity device|Accelerometer that has all the steps, distance, calories, and sleep data blinded to the study subject
16213722|NCT01287195|Drug|Oral OKT3|1 mg or 2 mg Oral OKT3 will be given orally to participants once daily for 30 days
16213723|NCT01287195|Drug|Omeprazole|20 mg Omeprazole will be given orally to participants once daily for 30 days
16213724|NCT01287182|Drug|Ateronon|Ateronon daily for 3 months
16213725|NCT01287130|Drug|Cetuximab|Day 1 administer cetuximab 400 mg/m2 IV loading dose over 120 minutes. On days 8, 15 and 22 administer cetuximab 250 mg/m2 IV loading dose over 60 minutes
16213726|NCT01287130|Drug|AZD6244|Given orally once or twice a day depending on dose level.On days 1, 8, 15 and 22. Repeat every 28 days
16213727|NCT01287117|Drug|Omalizumab|Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.
16213728|NCT01287117|Drug|Placebo|Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug.
16213729|NCT01287104|Biological|Natural Killer (NK) Cell Infusion|Post-transplant Day 21 (plus-minus 3 days): (1 x 10(5), 1 x 10(6) or 1 x 10(7) natural killer (NK) cells/kg by intravenous (IV) infusion. Followed by a second NK cell infusion of the same cell dose, on Day 49 plus-minus 7 days.
16213730|NCT01287104|Biological|Stem Cell Infusion|Transplant Day 0: >4 x 10(6)/kg cluster of differentiation 34 (CD34)+ stem cells by IV infusion Filgrastim, 5 microgram/kg per day subcutaneous (SQ) from day 0 until absolute neutrophil count (ANC) >5000/microliters x2
16213731|NCT01287091|Drug|GDC-0980|Oral tablet dose
16213732|NCT01287091|Drug|GDC-0980|Oral capsule dose
16213733|NCT01287091|Drug|GDC-0980|Oral tablet dose in fed state
16213734|NCT01287091|Drug|GDC-0980|Oral repeating dose in fasting state
16213735|NCT01287091|Drug|GDC-0980|Oral repeating dose in fed state
16213736|NCT01287091|Drug|GDC-0980|Oral tablet in a fasting state
16213737|NCT01287091|Drug|rabeprazole|Oral repeating dose
16213738|NCT01287078|Drug|Cyclosporine Inhalation Solution|sterile, clear, colorless, preservative-free solution of cyclosporine (USP) in propylene glycol developed specifically for administration by oral inhalation.
16213739|NCT01287065|Drug|FF(100mcg)/Vilanterol(25mcg) AM|Inhalation powder
16213740|NCT01287065|Drug|FF(100mcg)/Vilanterol(25mcg) PM|Inhalation powder
16213741|NCT01287065|Drug|Placebo AM|Inhalation powder
16213742|NCT01287065|Drug|Placebo PM|Inhalation powder
16213774|NCT01286805|Procedure|Control|The control group will receive only a combined spinal-epidural.
16213775|NCT01286779|Biological|BAX 326 (Recombinant factor IX)|The treatment with BAX 326 will be at the discretion of the investigator and will consist of either twice weekly prophylactic treatment with 50 IU/kg, modified prophylaxis, or on-demand treatment.
16213776|NCT01286766|Drug|DCS (docetaxel with cisplatin with TS-1)|"S-1: 70 mg/m2 #2 bid PO, D1-14
~Docetaxel 30 mg/m2 IVF (for 1 hr) D1 and D8
~Cisplatin 30 mg/m2 IVF (for 2 hrs, without hydration) D1 and D8, repeated by 3 weeks."
16213743|NCT01287052|Drug|Nitrous Oxide|Once consent is obtained, the research assistant will notify the charge RN and MD of the patient's study participation. The patient will then be placed in a treatment room and nitrous oxide will be administered per the existing protocol. Each participant will be given nitrous oxide until he/she reports a pain score of zero or up to fifteen minutes. Study subjects will be asked to rate their pain on a scale of 0-10 before the treatment and after the treatment, the time duration of administering nitrous oxide will be recorded. In addition, the pain scores at 30, 60, 90, and 120 minutes post baseline measurement will be collected in order to evaluate the sustained effect of nitrous oxide in treating acute migraine pain. Someone from the study will also make a follow-up phone call 24 - 48 hours to see if pain relief persisted.
16213744|NCT01287039|Drug|Reslizumab|Patients were administered intravenously over 15 to 30 minutes reslizumab at a dosage of 3.0 mg/kg at baseline and once every 4 weeks relative to baseline over 48 weeks for a total of 13 doses.
16213745|NCT01287039|Drug|Placebo|Matching placebo (20 mM sodium acetate, 7% sucrose), administered intravenously (iv) once every 4 weeks over 52 weeks, for a total of 13 doses administered. Each patient received a specific volume of placebo to match the volume of reslizumab on the basis of the patient's body weight.
16213746|NCT01287026|Procedure|Cardiac Real-time MRI RHC (Right Heart Catheterization)|
16213747|NCT01287013|Device|Cone-beam computed tomography (CT)|Imaging
16213748|NCT01287013|Device|Conventional Computed Tomography (CT)|Imaging
16213749|NCT01286987|Drug|Talazoparib|Oral capsule with multiple dosage forms given once daily
16213750|NCT01286974|Drug|[14C]linifanib|[14C]linifanib, single administration, oral liquid
16213751|NCT01286974|Drug|ABT-869, linifanib|linifanib once a day (QD), oral tablet
16213752|NCT01286961|Drug|bowel preparation using split dose of polyethylene glycol|polyethylene glycol, split dose(2L/2L), each dose for 1-2hours
16213753|NCT01286948|Drug|Levonorgestrel (LNG) gel (Levogel) and oral LNG (Plan B)|"This is a randomized study with a cross-over design comparing two single dose treatment sequences of either Levogel (LNG vaginal gel 0.750 mg/4g) or oral LNG (1.5mg).
~All women with a leading follicle diameter of ≥18 mm will be randomized to treatment with a single intra-vaginal application of LNG gel or oral LNG. After a washout cycle, the women will be crossed over to receive the other treatment and the study procedures will be repeated."
16213754|NCT01286935|Drug|Safinamide|
16213755|NCT01286935|Drug|Safinamide|
16213756|NCT01286935|Drug|Placebo|
16213757|NCT01286922|Other|Behavioral: exercise|"Specific Aim: We will identify, recruit, assess, and randomly assign 42 sedentary, overweight-obese individuals who are at risk for pre-diabetes to an AER or INT training group in order to test the hypothesis:
~• Individuals randomized to INT will have greater improvements in insulin sensitivity than individuals assigned to traditional AER.
~Secondary Aim: We will measure maximal cardiorespiratory fitness (VO2max/peak) in order to test the hypothesis:
~• Individuals randomized to the INT group will have a greater improvement in VO2max/peak than individuals in traditional AER group."
16213758|NCT01286909|Dietary Supplement|LaFlavon|two tablets of LaFlavon (two x 3.5mg lycopene/25 mg soy isoflavone) daily for three months
16213759|NCT01286896|Drug|Sunitinib|"Patients will start treatment with a continuous once-daily dose of 37.5 mg sunitinib. After 22 days the first dose modification will be performed based on the total trough levels (TTL) combined for sunitinib plus SU12662 as measured by dried blood spot (DBS) analyses taken at day 15 ± 1day. A second dose modification will be performed after 36 days (7 days after the first dose adjustment) based on the TTL taken at day 29 ± 1day. One treatment cycle is defined as 28 days.
~After 8 weeks a third analyses for TTL will be performed without further consequences for sunitinib dosing. Patients will be evaluated by CT- or MRI-scans for the response to therapy at week 8, and thereafter every 12 weeks. One blood sample will be harvested for pharmacogenetic analyses."
16213760|NCT01286870|Device|Mentor Becker 25 Expander/Breast Implant|"The breast implant is comprised of the Becker implant and the injection dome/fill tube and has a low bleed, gel-filled outer lumen and an adjustable saline-fillable inner lumen. The inner lumen can be gradually filled with saline over an extended period of time via the fill tube by injecting saline through the injection dome. Once expanded to the desired volume, the fill tube and injection dome are removed through a small incision under local anesthetic, and the prosthesis remains in position as a breast implant.
~The Becker 25 Expander/Breast Implant has a silicone gel volume of approximately 25% and saline volume of approximately 75%. The Becker Expander/Breast Implant is available in sizes 150 - 800cc."
16213761|NCT01286870|Device|Mentor Becker 50 Expander/Breast Implant|"The breast implant is comprised of the Becker implant and the injection dome/fill tube and has a low bleed, gel-filled outer lumen and an adjustable saline-fillable inner lumen. The inner lumen can be gradually filled with saline over an extended period of time via the fill tube by injecting saline through the injection dome. Once expanded to the desired volume, the fill tube and injection dome are removed through a small incision under local anesthetic, and the prosthesis remains in position as a breast implant.
~The Becker 50 Expander/Breast Implant has a 50% gel volume and a 50% saline volume, so a 400cc implant would nominally have 200cc of saline and 200cc of silicone. The Becker 50 Expander/Breast Implant is available in sizes from 300 to 700cc."
16213762|NCT01286857|Device|External Suction Interface and a Silicon Film|Evaluate the function of a new silicon cover film and an on-top suction device to be used in a NPWT system in the treatment of acute and chronic wounds.
16213763|NCT01286844|Drug|GSK2190915A 5mg|Oral powder for dispersion in water
16213764|NCT01286844|Drug|GSK2190915A 10mg|Oral powder for dispersion in water
16213765|NCT01286844|Drug|GSK2190915A 25mg|Oral powder for dispersion in water
16213766|NCT01286844|Drug|GSK2190915A 50mg|Oral powder for dispersion in water
16213767|NCT01286844|Drug|GSK2190915A 100mg|Oral powder for dispersion in water
16213768|NCT01286831|Drug|[14C]GW642444|Single 200μg dose of [14C]GW642444 given on Day 1.
16213769|NCT01286818|Biological|Ramucirumab (IMC-1121B)|Ramucirumab (IMC-1121B): Intravenous (IV) infusions, 8 milligrams per kilogram (mg/kg) every 2 weeks
16213770|NCT01286818|Drug|Irinotecan|IV Infusion, 180 milligrams per square meter (mg/m²) every 2 weeks
16213771|NCT01286818|Drug|levofolinate|IV infusion, 200 mg/m² every 2 weeks
16213772|NCT01286818|Drug|5-Fluorouracil (5-FU)|400 mg/m² bolus followed by a 2400 mg/m² continuous infusion, every 2 weeks
16213773|NCT01286805|Procedure|Lumbar Plexus Blockade|The lumbar plexus block will be dosed with 30 milliliters of 0.25% bupivacaine with 1:200,000 epinephrine
16213777|NCT01286766|Drug|DCF (docetaxel with cisplatin with 5-FU)|"5-FU: 1,000 mg/m2 CI, D1-3
~Docetaxel 60 mg/m2 IVF (for 1 hr) D1 followed by
~Cisplatin 60 mg/m2 IVF (for 2 hrs, with hydration) D1, repeated by 3 weeks.
~Intercycle or intracycle dose modification is indicated if ≥G3 hematologic toxicity (except anemia) or ≥G3 non-hematologic toxicity (except alopecia)
~treatment is repeated until 4 cycles"
16213778|NCT01286753|Drug|Vemurafenib|Vemurafenib 960 mg orally twice daily.
16213779|NCT01286740|Drug|FTC/RPV/TDF|Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg single-tablet regimen (STR) administered orally with a meal once daily
16213780|NCT01286727|Drug|BB3|intravenous drug
16213781|NCT01286714|Device|CLIP OST|
16213782|NCT01286701|Drug|Terbinafine Hydrochloride Tablets, 250 mg|Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Laboratories Limited.
16213783|NCT01286688|Drug|Terbinafine Hydrochloride Tablets, 250 mg|Terbinafine Hydrochloride Tablets, 250 mg of Dr. Reddy's Laboratories Limited.
16213784|NCT01286675|Drug|Eltrombopag|oral eltrombopag, 50 mg, 100 mg, 150 mg, days 2-15
16213785|NCT01286649|Other|Human autologous hair follicle cells|Human autologous hair follicle cells suspended in cell medium
16213786|NCT01286649|Other|Cell medium|Cell medium
16213787|NCT01286636|Other|computer model|Diagnosis of Sleep apnea and treatment guidance will rely on a computer model prediction.
16213788|NCT01286636|Other|Polysomnogram|Diagnosis of sleep apnea will rely on polysomnogram
16213789|NCT01286610|Device|ProMedVi Vibrosphere|vibration therapy
16213790|NCT01286610|Device|schwa-medico MUSKELaktiv|Electrical muscle stimulation
16213791|NCT01286610|Device|Galileo Home Plus (ICU)|vibration therapy
16213792|NCT01286597|Dietary Supplement|dietary restriction|restrict intake of lactose
16213793|NCT01286584|Drug|varenicline|one 0.5mg varenicline capsule on first 3 days one 0.5mg varenicline capsule, twice daily for 4 days one 1.0mg varenicline capsule, twice daily until end of treatment (12weeks of medication
16213794|NCT01286584|Drug|placebo|lactose filler in capsules identical to the varenicline capsules one 0.5mg capsule for 3 days one 0.5mg capsule twice daily for 4 days one 1.0mg capsule twice daily until end of treatment (12weeks of medication)
16213795|NCT01286571|Drug|BI 135585|one oral single dose per subject
16213796|NCT01286571|Drug|BI 135585|one oral single dose per subject
16213797|NCT01286558|Drug|40 mg telmisartan|once daily
16213798|NCT01286558|Drug|5 mg amlodipine|once daily
16213799|NCT01286558|Drug|5 mg amlodipine|once daily
16213800|NCT01286558|Drug|80 mg telmisartan|once daily
16213801|NCT01286493|Biological|rabies vaccines on day 0 and 3|All subjects would receive conventional intramuscular booster rabies vaccination on day 0 and 3. Their blood would be drawn for rabies neutralizing antibody on day 0,7,14,30,90,180,360
16213802|NCT01286480|Behavioral|Clinic-based Educational Intervention|This will involve a 60 minute interaction between the teen and an advanced practice nurse (APN) in the cardiology clinic. A MyHealth passport will be created covering the name of the teen's cardiac condition, previous cardiac interventions, and name and purpose of the teen's medications. Potential late cardiac complications and contact names and location of local adult CHD cardiologists will also be reviewed. Three scenarios regarding adolescent risk taking behaviors (written in the 3rd person) will be presented to the teen who will be asked what advice he/she would offer to the teen in each of those scenarios. The teen will be given a study email address and encouraged to contact the APN by email or text messaging with follow-up questions. If no contact is initiated after 1 week, the APN will email or text (based on preference) the youth, to discuss additional questions.
16213803|NCT01286467|Drug|PF-04449913|Escalating dose of PF-04449913 administered as tablets PO QD in 28-day cycles
16213804|NCT01286454|Drug|fesoterodine|single dose of beads in capsule
16213805|NCT01286454|Drug|fesoterodine|single dose of beads in capsule
16213806|NCT01286454|Drug|fesoterodine|single dose of beads in capsule
16213807|NCT01286454|Drug|fesoterodine|single dose of beads in capsule
16213808|NCT01286454|Drug|fesoterodine|single dose of tablet
16213809|NCT01286454|Drug|fesoterodine|single dose of beads in capsule
16213810|NCT01286441|Drug|10% EISO|During the Treatment Period, subjects will apply study medication (10% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
16213811|NCT01286441|Drug|Placebo|During the Treatment Period, subjects will apply placebo to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
16213812|NCT01286441|Drug|20% EISO|During the Treatment Period, subjects will apply study medication (20% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
16213813|NCT01286441|Drug|30% EISO|During the Treatment Period, subjects will apply study medication (30% EISO) to all warts in the treatment area for 12 weeks and will then be followed for an additional 12 weeks. Subjects achieving complete resolution will continue to apply the study medication for the entire 12-week treatment period. During the Follow-up Period, subjects will be followed by telephone every 4 weeks for 12 weeks.
16213814|NCT01286415|Behavioral|Group Cognitive Processing Therapy-Cognitive Only|Cognitive Processing Therapy (CPT) is an evidence-based form of Cognitive Behavioral Therapy (CBT) used to treat PTSD. CPT is a 12-session manualized program that focuses on challenging beliefs and assumptions related to the trauma, oneself, and the world. Sessions will be conducted twice weekly for six weeks; each session is 90 minutes.
16213853|NCT01286116|Device|Parachute Implant|Mechanical ventricular partitioning
16213854|NCT01286103|Drug|Canagliflozin 300 mg once daily and 150 mg twice daily|Treatment A (one 300-mg tablet once daily for 5 days) followed 10 days later by Treatment B (one 50-mg and one 100-mg tablet twice daily for 5 days) or Treatment B followed by Treatment A.
16214650|NCT01279668|Drug|Placebo|tablets, once per day for 28 days.
16213815|NCT01286415|Behavioral|Group Present Centered Therapy|Present Centered Therapy (PCT) is a supportive group intervention typically used within the Department of Veterans Affairs (VA) healthcare systems to address problems of veterans with PTSD (Rosen, et al., 2004). PCT focuses on problem-solving current difficulties that may be related to past traumatic events, but does not address specific memories or cognitions about the trauma. Sessions will be conducted twice weekly for 6 weeks; sessions are 90 minutes.
16213816|NCT01286402|Drug|Bupropion SR|"150mg, taken orally, taken daily for the 1st 3 days
~300mg, taken orally, taken daily for the rest of the 8 weeks of drug treatment"
16213817|NCT01286402|Other|Placebo|-Avicel PH 302, Emcocel 50M, Cab-O-Sil M5P, Magnesium Stearate (appearance, taste, and dosing instructions were identical to the bupropion group), i.e., 1 pill orally, taken daily for the 1st 3 days; 2 pills, taken orally, taken daily for the rest of the 8 weeks of drug treatment
16213818|NCT01286389|Other|medical care|Conventional medical care, geriatric consultations at least 6 times in 12 months, short lifestyle counseling (exercise+healthy diet)
16213819|NCT01286389|Behavioral|caloric restriction|Nutritional guidance: through at least 2 individual assistance and group sessions, lasting 1 hour, weekly for 4 months, and biweekly for 2 months and monthly thereafter (26-28 meetings/1year).The diet plan will recommend a deficit from 500 to 750 kcal/day in order to promote loss of about 0.5kg/week, containing 1g/kg of protein per day (minimum 1200kcal/day), high in fiber, vegetables and whole foods. The goal of weight loss will be 10% of initial weight. Group activities consist of lectures on nutrition education, food composition and its importance to health, food preparation techniques, self-monitoring weight, eating behavior and count calories.
16213820|NCT01286376|Dietary Supplement|Symbiotic Lactofos|Lactobacillus Paracasei Lactobacillus Rhamnosus Lactobacillus Acidophilus Bifidobacterium lactis 12g/day
16213821|NCT01286376|Dietary Supplement|Maltodextrin|Maltodextrin
16213822|NCT01286350|Behavioral|FL3X: Flexible Lifestyle Empowering Change|The FL3X Adaptive Intervention is designed to increase adherence to T1D self-management including medical management (blood sugar testing and insulin dosing), diet, and physical activity. FL3X relies on MI, and problem-solving skills training (PSST) as the basis for the counseling strategy, and creates a coherent integration across three key components of 1) behavior family systems therapy focused on family communications and teamwork; 2) individualized diabetes education in response to knowledge gaps relevant to behavioral goal attainment; and 3) use of currently available communications technology to support behavioral goal attainment through participant-defined reminders and motivational boosters, and/or peer support.
16213823|NCT01286337|Procedure|bipolar vessel sealing|
16213824|NCT01286337|Procedure|control|
16213825|NCT01286324|Dietary Supplement|Chamomile High Grade Extract|three tablets each (equivalent to 7.5 g of dried herb) p.o. twice daily for 28 days
16213826|NCT01286324|Drug|Placebo Tablet|
16213827|NCT01286311|Behavioral|Direct-to-patient tailored cardiovascular risk message system|Patient informational mailings
16213828|NCT01286298|Procedure|Laser gingivectomy|Gingivectomy by diode laser
16213829|NCT01286298|Procedure|Laser gingivectomy|Diode laser gingivectomy for gingival enlargement
16213836|NCT01286259|Drug|Disulfiram|Open label 500mg disulfiram per day by mouth for 14 days
16213837|NCT01286246|Drug|Vaginal progesterone|Capsules of 200mg micronised progesterone suspended in sunflower oil. One capsule inserted vaginally per day from time of randomisation to gestational age 35(+6)weeks or delivery (if sooner).
16213838|NCT01286246|Drug|Placebo|Capsules of placebo (sunflower oil). One capsule inserted vaginally per day from time of randomisation to gestational age 35(+6)weeks or delivery (if sooner).
16213839|NCT01286233|Drug|Metformin|
16213840|NCT01286233|Drug|Placebo|
16213841|NCT01286220|Other|Dilute bleach baths|Patients in the intervention group will be instructed to bathe in a dilute bleach bath twice weekly for 10 minutes.
16213842|NCT01286220|Other|Water|Patients in the placebo group will be instructed to bathe in plain water twice weekly for 10 minutes.
16213843|NCT01286207|Drug|Rizatriptan 5 mg|Rizatriptan 5 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
16213844|NCT01286207|Drug|Rizatriptan 10 mg|Rizatriptan 10 mg orally once for treatment of index migraine attack, followed by two additional doses within 24 hours of the initial dose for migraine recurrence(s)
16213845|NCT01286207|Drug|Standard Care|Active standard care
16213846|NCT01286194|Drug|Rabeprazole sodium|Rabeprazole sodium 10 mg orally every day for 14 days
16213847|NCT01286181|Behavioral|Twice daily practice of device-guided slow breathing.|Participants are asked to use the slow-breathing device for 20 minutes twice daily, for 8 weeks. Participants receive weekly telephone calls to monitor device use and are encouraged to use pursed-lips when following the breathing tones of the device while exhaling.
16213848|NCT01286168|Device|Sodium hypochlorite (Dakin's Solution)|10 ml of 0.125% sodium hypochlorite (Dakin's solution) irrigation to the drainage bulb two times a day
16213849|NCT01286168|Device|Chlorhexidine gluconate disk|Apply one chlorhexidine disk to the intervention drain site(s) and change every three days
16213850|NCT01286168|Procedure|Control|Standard drain care will be performed twice a day or three times if bulb is full and needs to be emptied. Standard drain care consists of stripping the tubing, emptying the drainage bulb, recording the volume of fluid, and cleaning the drain site with a cotton swab dipped in rubbing alcohol. The drain exit will be covered with a dry sterile gauze dressing and changed after each episode of drain care.
16213851|NCT01286168|Device|Occlusive Adhesive Dressing|A chlorhexidine gluconate disk (BioPatch) covered by an occlusive adhesive dressing (Tegaderm) will be applied to the intervention drain sites and changed every three days.
16213852|NCT01286129|Procedure|Nasal allergen challenge|Allergen sprayed into nostrils. Allergen used will be house dust mite or cat allergen. Allergens will be given in increasing ten-fold dilutions until a positive response occurs.
16214873|NCT01277913|Drug|Vitamin D3|500 IU once daily for 12 months
16213855|NCT01286103|Drug|Canagliflozin 100 mg once daily and 50 mg twice daily|Treatment C (one 100-mg tablet once daily for 5 days) followed 10 days later by Treatment D (one 50-mg tablet twice daily for 5 days) or Treatment D followed by Treatment C.
16213856|NCT01286090|Drug|Cisapride|One 10-mg tablet taken orally 4 times a day for up to 8 weeks.
16213857|NCT01286090|Drug|Placebo|One tablet taken orally 4 times a day for up to 8 weeks.
16213858|NCT01286077|Drug|bortezomib|Each cycle will consist of 5 weeks treatment. Subjects in the treatment group will receive: Velcade® 1.6 mg/m2 as an intravenous bolus injection on Days 1, 8, 15, and 22 of each cycle followed by a 13-day rest period (Days 23 to 35) Cycle will be repeated on Day 36. Subjects in the treatment group will receive up to 4 treatment cycles, unless they experience either unacceptable toxicity or if the subject requests to withdraw from the study.
16213859|NCT01286064|Device|Optical Fluoroscopy|Lithium-heparin was added to the blood samples to prevent coagulation. The samples were then centrifuged and the plasma was removed without disturbing the buffy coat and the erythrocyte sediments. The separated changes in the enzyme associated with heme biosynthesis have been reported for peripheral mononuclear cells in patients with epithelial tumors and metastatic spread. plasma was stored at -20 °C until assayed. For fluorescence measurements, analytical grade acetone was added to plasma in a 1:1 ratio by volume and the mixture was centrifuged. The clear supernatant was placed in a quartz cuvette of 1 cm path length for further analysis. Fluorescence analysis of blood plasma was performed by means of a spectrofluorometer (Model F-3000, Hitachi, Ltd., Tokyo, Japan).
16213860|NCT01286064|Device|Optical Fluoroscopy|Lithium-heparin was added to the blood samples to prevent coagulation. The samples were then centrifuged and the plasma was removed without disturbing the buffy coat and the erythrocyte sediments. The separated changes in the enzyme associated with heme biosynthesis have been reported for peripheral mononuclear cells in patients with epithelial tumors and metastatic spread. plasma was stored at -20 °C until assayed. For fluorescence measurements, analytical grade acetone was added to plasma in a 1:1 ratio by volume and the mixture was centrifuged. The clear supernatant was placed in a quartz cuvette of 1 cm path length for further analysis. Fluorescence analysis of blood plasma was performed by means of a spectrofluorometer (Model F-3000, Hitachi, Ltd., Tokyo, Japan).
16213861|NCT01286051|Drug|Follistim administration|adminstation of FSH for ovulation induction
16213862|NCT01286051|Drug|Follistim plus Ganirelix|Follistim plus single injection of ganirelix
16213863|NCT01286038|Drug|Eltrombopag|In Stage 1 the best dose of eltrombopag will be found to take into Stage 2, which will treat 15 participants at this dose.
16213864|NCT01286025|Behavioral|video case modality|Patients whose case histories are pathophysiologically illustrative will be recruited, and interviewed on video. Their stories will be edited and divided into sections, and combined with the patient's laboratory, imaging, and pathological reports when appropriate
16213865|NCT01286025|Behavioral|Text case modality|Patients whose case histories are pathophysiologically illustrative will be recruited, and interviewed on video. Their stories will be edited and divided into sections, and combined with the patient's laboratory, imaging, and pathological reports when appropriate. The transcript of these video-recordings will form the basis of the text-based case presentation modality.
16213866|NCT01286012|Drug|Soluble Ferric Pyrophosphate in liquid bicarbonate|Subjects will receive hemodialysis containing SFP at 2 µM (11 µg iron/dL of dialysate) at every dialysis session, for a total duration of 36 weeks.
16213867|NCT01286012|Drug|Placebo: Conventional liquid bicarbonate|Subjects will receive hemodialysis containing conventional liquid bicarbonate lacking SFP at every dialysis session, for a total duration of 36 weeks.
16213868|NCT01286012|Drug|Erythrocyte Stimulating Agent (ESA)|ESA was administered according to the recommendation of a blinded central anemia management center (CAMC) based on the weekly hemoglobin value and its rate of change.
16213869|NCT01286012|Drug|Intravenous (IV) Iron|Approved IV iron preparations were administered per a protocol driven algorithm when patients serum ferritin value decreased below 200 ug/L.
16213870|NCT01285999|Device|PROMUS Element Coronary Stent System|Everolimus-eluting Coronary Stent
16213871|NCT01285999|Device|TAXUS Liberté Coronary Stent System|Paclitaxel-eluting Coronary Stent
16213872|NCT01285986|Procedure|Vein collar at the distal anastomosis|Vein collar interposed at the distal anastomosis or No vein collar interposed at the distal anastomosis
16213873|NCT01285960|Device|ExAblate Treatment UF V2|Treatment with the ExAblate UF V2 system. Patients may have up to two ExAblate treatments within a two-week period.
16213874|NCT01285947|Device|Thermage|Radiofrequency Device - specific setting will be determined by the location and thickness of skin. Periorbital: 58-140 J/cm2 Midface: 81-124 J/cm2 Abdomen: 95-181 J/cm
16213875|NCT01285947|Other|Needle Application|30-gauge needle insertion into skin
16213876|NCT01285947|Device|VBeam Laser|Pulsed Dye Laser at the following settings: 7.5 J, 0.6ms, 10mm, DCD 30/20
16213877|NCT01285947|Device|Ulthera|"Ultrasound Device at the following settings:
~Transducer Frequency Depth Image Depth DS 7-3.0 7 MHz 3.0mm 0-8mm DS 4-4.5 4 MHz 4.5mm 0-8mm DS 7-4.5 7 MHz 4.5mm 0-8mm"
16213878|NCT01285934|Biological|Autologous Hematopoietic Stem Cell Transplantation|All participants randomized to the transplant arm wil undergo Autologous Hematopoietic Stem Cell Transplantation
16213879|NCT01285934|Drug|intensive insulin therapy|The control arm will be either CSII via an insulin pump or intensive subcutaneous insulin therapy with multiple insulin injections (at least 4/day) utilizing a long acting background insulin and pre-meal rapid acting insulin.
16213880|NCT01285921|Other|vestibular test before and after hippocampal surgery|"Research of a spontaneous nystagmus with and without fixation(VIDEONYSTAGMOSCOPY) and segmentary deviations (Fukuda test)
~HIT (testing semicircular canal function at high frequency).Results: Gain in %
~VEMp (testing saccular function). Results: Amplitude in μV and latency in ms
~ERI (testing lateral semicircular function at middle frequency). Results: Nystagmus during and after the rotations in frequency and slow phase velocity (SPV) in °/s
~Caloric test (testing lateral semicircular function at low frequency). Results: Canal paresis in % and SPV in °/S"
16213881|NCT01285908|Drug|Intravenous Norepinephrine Infusion|
16213906|NCT01285635|Drug|AT-101|Pulse Dose: AT-101 dose of 40 mg b.i.d. on days 1-3 Metronomic Dose: AT-101, 20 mg daily, days 1-14
16213907|NCT01285635|Drug|Docetaxel|Docetaxel 75 mg/m2 on Cycle Day 1
16213908|NCT01285609|Drug|Ipilimumab|
16213909|NCT01285609|Drug|Placebo|
16213910|NCT01285609|Drug|Paclitaxel|
16213911|NCT01285609|Drug|Carboplatin|
16213882|NCT01285882|Other|Representations|"A pre-test with 5 medical persons and 5 persons without mucoviscidosis will be realized to adjust the tools and place of the interview.
~To collect analyzable data for 30 patients, 40 patients will be included in the study. A conceptual card will be associated to a semi-structured interviews to gather information.Two subgroups will be considered in th a analysis :
~1st sub-group : After the announcement of the transplant indication by the doctor and before the consultation in the transplant centre.
~2nd subgroup : After the consultation in the transplant centre but before the inscription on the waiting list. The analysis of conceptual cards in these two subgroups will permit to study the differences between the representations of patients before and after the consultation in the transplant centre.
~Realize a 2nd interview on the same principle with all patients, 1 year after their lung transplantation."
16213883|NCT01285869|Other|Multidimensional intervention|The patient will be cited 2 months after hospital discharge for a geriatric evaluation carried out by a geriatric nurse and an internist with geriatric training. The duration of the first visit is 45-60 minutes. The visit consists of: 1. Assessment of the pneumonia resolution, co-morbidities, aspiration risk, risk of multiresistant infections, and the immunization, functional and cognitive status. 2. An individualized intervention plan. The patient and family or caregiver will receive an educational intervention, a written report with the planned intervention and an educational leaflet. Those patients who require further assessment or follow up of the intervention will receive 1 or 2 more visits and all the patients will be cited one year after the first visit.
16213884|NCT01285856|Other|hair and saliva samples|"Using a sample of hair, testing for and measurement of the principal drugs (opiates, cannabis, cocaine, amphetamines) and the specific marker of ethanol consumption, ethyl glucuronide, will be performed by chromatographic techniques (high-performance liquid chromatography and gas phase chromatography) together with detection by mass or tandem mass spectrometry. This non-invasive sampling is more informative than blood tests, as it gives a retrospective profile of an individual's consumption over several months.
~Saliva sample, a method which gives similar results without the need for venous blood sampling."
16213885|NCT01285843|Procedure|Anterior Minimally Invasive Approach (AMIS)|
16213886|NCT01285830|Dietary Supplement|Lactobacillus reuteri|The mothers started taking Lactobacillus reuteri ATCC 55730 (BioGaia AB, Stockholm, Sweden) or placebo four weeks before term and continued to do so daily until delivery. After birth, the baby commenced with the same study product as the mother at 1-3 days of age and continued daily for one year. The daily intake, five oil droplets, corresponded to 1 x 100 000 000 colony forming units (CFU)
16213887|NCT01285830|Dietary Supplement|Placebo|The placebo consists of the same oil that the active study product but without any bacteria and is not possible to differentiate from the active product by smell, taste or visual appearance
16213888|NCT01285817|Drug|celecoxib, Vinblastine, Cyclophosphamide , methotrexate ,|
16213889|NCT01285804|Other|Cuffed ETT|Kimberly Clark
16213890|NCT01285804|Other|Uncuffed ETT|Kimberly Clark
16213891|NCT01285778|Drug|panitumumab, mytomicin C, 5-FU, radiation|"Radiation therapy will be administered concurrent with chemotherapy and Panitumumab treatment. It will start the day 1 of the systemic treatment. That is, the first day of radiation therapy will be the day of the administration of the first dose of Panitumumab and Mitomycin C, as well as the first day of the first 96-hours course of 5-FU continuous infusion. On day 1, drugs and radiation will be administered in the following order:
~First, Panitumumab. Panitumumab will be administered by IV infusion on day 1, and every 2 weeks during 8 weeks
~Then Mitomycin C, 10mg/m2 on days 1 and 29
~Then start the 5-FU continuous infusion, 1000mg/m2 on days 1-4 and 29-32
~Finally, no less than 2 hours after the start of the 5-FU infusion, first dose of radiation therapy."
16213892|NCT01285765|Drug|RCHOP21|Prednisone-60 mg/m2: D1 D2 D3 D4 D5;Rituximab-375 mg/m2 : D1; Doxorubicin-50 mg/m2 D1;Cyclophosphamide-750 mg/m2:D1 Vincristine-1.4 mg/m2 :D1; G-CSF SC -5 microg/kg/day: D6 to D13
16213893|NCT01285752|Drug|AK106-001616|
16213894|NCT01285752|Drug|AK106-001616|
16213895|NCT01285752|Drug|Active comparator|
16213896|NCT01285739|Other|WBC, biomarkers, TBA, chest X ray|The above cited parameters were recorded and investigated every six months; chest X ray when needed.
16213897|NCT01285739|Other|WBC, biomarkers, TBA, chest X ray|The above cited parameters were recorded and investigated every six months; chest X ray when needed.
16213898|NCT01285726|Other|Non-interventional study|This is a purely non-interventional, observational study, where treatment decisions are completely guided by the discretion of the attending nephrologists.
16213899|NCT01285713|Drug|5% Dextrose (D5) in Normal Saline (NS)|D5NS 10 cubic centimeter (cc)/kilogram (kg) to be followed by 30cc/kg of NS
16213900|NCT01285713|Drug|Normal Saline (NS)|NS 10 cubic centimeter (cc)/kilogram (kg) to be followed by 30cc/kg NS
16213901|NCT01285700|Drug|Lamazym|ERT, infusion weekly
16213902|NCT01285687|Device|acupuncture|Sterile, disposable, FDA-approved acupuncture needles will be used. Acupuncture will be performed bilaterally. The needles will penetrate the skin to a depth of 5-10mm and will be kept in place for no more than 5 minutes. The acupuncture points will be: Li 4, Li 11, St 44, according to Chinese acupuncture mapping. Treatment will be repeated at least 3 times during the hospital stay. Treatment will start in the pediatrics department approximately two hours after discharge from the postoperative unit. The 2nd treatment will be given on the same evening, approximately 4-8 hours after the 1st treatment and the 3rd treatment will be given the following morning, approximately 12-18 hours after the 2nd treatment. Exact treatment times will be recorded in the patient's file.
16213903|NCT01285674|Drug|Intra-tympanic Cisplatinum|Intra-tympanic injection (under local anesthesia) of 0.5cc Methylprednisolone 62.5mg/cc. One injection per ear before each of the 3 cisplatin treatments. After injection the patient will remain with the treated ear upwards for 20 minutes and will try to avoid swallowing as much as possible.
16213904|NCT01285661|Drug|Sodium warfarin|Patients with early vein recanalization, as shown by ultrasonography, and repeatedly negative D-dimer will have anticoagulation discontinued. They will be followed-up for up to 4 years after recruitment in order to assess the rate of recurrent symptomatic VTE. In all other patients anticoagulation will not be discontinued.
16213905|NCT01285648|Procedure|Cpap|This study did not involved drugs. The Oxygenation index, Borg Scale, pain scale and the presence and duration of thoracic drainage was determined in the immediate postoperative (POi) period and in the first and second postoperative (PO1, PO2) days in 40 patients who underwent elective lung resection,in two groups of intervention: chest physiotherapy, and associate this with cpap
16213912|NCT01285596|Drug|Mirabegron|oral
16213913|NCT01285583|Drug|TRO19622|2 capsules of TRO19622 (330mg) once a day with the noon meal as add-on therapy to riluzol 50mg bid
16213914|NCT01285570|Drug|Ulimorelin Intravenously (IV)|480 microg/kg daily (QD)
16213915|NCT01285570|Drug|Ulimorelin Intravenously (IV)|160 microg/kg daily (QD)
16213916|NCT01285570|Drug|5% dextrose in water|Placebo
16213917|NCT01285557|Drug|S-1 (Tegafur/Gimeracil/Oteracil) /cisplatin (investigational arm)|25 mg/m² body surface area (BSA) orally 2 times daily from Days 1 through 21 followed by a 7 day rest period, plus cisplatin 75 mg/m2 BSA on Day 1 each 28 day cycle Number of Cycles: until progression or unacceptable toxicity develops. Treatment with cisplatin is limited to a maximum of 8 cycles.
16213918|NCT01285557|Drug|Fluorouracil/cisplatin (control arm)|"5-FU: 800 mg/m2 BSA/24 hours by continuous intravenous infusion (CIV) from Days 1 through 5 plus cisplatin 80 mg/m2 BSA on Day 1 each 21 day cycle.
~Number of Cycles: until progression or unacceptable toxicity develops. Treatment with cisplatin is limited to a maximum of 8 cycles."
16213919|NCT01285544|Drug|Atorvastatin (Lipinon)|treatment of dyslipidemia administration : PO, qod
16213920|NCT01285544|Drug|Atorvastatin (Lipitor)|treatment of dyslipidemia administration : PO, qod
16213921|NCT01285531|Device|Compass Lumbar Puncture Enhanced|Participants randomly assigned to this group will receive a lumbar puncture using the Compass device.
16213922|NCT01285518|Drug|PF-05231023|0.5 mg QD IV x 1 day
16213923|NCT01285518|Drug|PF-05231023|1.5 mg QD IV x 1 day
16213924|NCT01285518|Drug|PF-05231023|5 mg QD IV x 1 day
16213925|NCT01285518|Drug|PF-05231023|15 mg QD IV x 1 day
16213926|NCT01285518|Drug|PF-05231023|50 mg QD IV x 1 day
16213927|NCT01285518|Drug|PF-05231023|100 mg QD IV x 1 day
16213928|NCT01285518|Drug|PF-05231023|200 mg QD IV x 1 day
16213929|NCT01285518|Other|Placebo|0.9% w/v sodium chloride injection, USP QD IVx 1 day
16213930|NCT01285505|Drug|alprazolam commercial sublingual formulation|0.5 mg tablet, single dose
16213931|NCT01285505|Drug|alprazolam test sublingual tablet|0.5 mg tablet, single dose
16213932|NCT01285492|Drug|QVA149|QVA149 (110 μg indacaterol / 50 μg glycopyrronium o.d.), delivered via Concept1
16213933|NCT01285492|Drug|Tiotropium|Tiotropium (18 μg o.d.), delivered via Handihaler®
16213934|NCT01285479|Drug|Fingolimod|
16213935|NCT01285479|Other|fingolimod|
16213936|NCT01285466|Drug|BEZ235 + paclitaxel|
16213937|NCT01285466|Drug|BKM120 + paclitaxel|
16213938|NCT01285466|Drug|BEZ235 + paclitaxel + trastuzumab|
16213939|NCT01285466|Drug|BKM120 + paclitaxel + trastuzumab|
16213940|NCT01285453|Drug|vadimezan|
16213941|NCT01285414|Drug|Verubulin|Verubulin, dose determined in Part A, i.v. once weekly, Temozolomide & Radiation Therapy
16213942|NCT01285414|Drug|Temozolomide & Radiation Therapy|Temozolomide & Radiation Therapy
16213943|NCT01285401|Drug|VigantOL oil plus interferon beta-1a (Rebif)|VigantOL oil 6,670 International Units per day (IU/d) (167 microgram per day [mcg/day]), was administered orally for 4 weeks followed by 14,007 IU/d (350 mcg/d) administered orally for 44 weeks on top of Rebif 44mcg three times per week (tiw) administered subcutaneously.
16213944|NCT01285401|Drug|Placebo plus interferon beta-1a (Rebif)|Matching placebo daily, orally administered matched placebo for 48 weeks on top of Rebif 44 mcg tiw.
16213945|NCT01285401|Biological|Interferon beta-1a (Rebif®) alone|Rebif® 44 mcg tiw, sub-cutaneously alone.
16213946|NCT01285388|Drug|MB12066|MB12066 10mg, 100mg/tab. once oral dose MB12066 10, 30, 100, 150, 200mg
16213947|NCT01285375|Device|CDC solution|2 ml of CDC 12/mg/ml is added to 1 l of UW solution. 500 ml of of this solution is used for flushing the kidney allograft prior to transplantation
16213948|NCT01285375|Device|UW-solution|500 ml of UW solution is used for flushing the kidney allograft prior to transplantation
16213949|NCT01285362|Drug|Fish Oil Supplementation|Group A will receive fish oil capsules, containing n3-Fatty Acids, at a dose of 4g/day. Each 1g capsule will contain 465mg of EPA and 375 mg of DHA.
16213950|NCT01285362|Drug|Placebo Supplementation|Group B will receive corn oil in the capsules at the same dose as Group A. The corn oil capsules will appear identical in size and color to the fish oil capsules.
16213951|NCT01285349|Behavioral|Couple HIV/STI prevention intervention|
16213952|NCT01285349|Behavioral|Couple-based HIV/STI prevention|
16213953|NCT01285349|Behavioral|Individual HIV/STI prevention|
16213954|NCT01285349|Behavioral|Couple Wellness Promotion|
16213955|NCT01285323|Drug|Reslizumab|Patients were administered intravenously over 15 to 30 minutes reslizumab at a dosage of 3.0 mg/kg at baseline and once every 4 weeks relative to baseline over 48 weeks for a total of 13 doses.
16213956|NCT01285323|Drug|Placebo|Matching placebo (acetate sucrose buffer), administered intravenously (iv) once every 4 weeks for a total of 13 doses.
16213957|NCT01285310|Drug|Apremilast 30 mg|30 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 30mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
16213958|NCT01285310|Drug|Apremilast 20 mg|20 mg oral Apremilast tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in the active treatment / active treatment extension phase.
16213959|NCT01285310|Drug|Placebo|Oral Placebo tablets administered twice daily (BID) for 24 weeks during the placebo-controlled phase followed by 20mg Apremilast tablets administered BID for up to 1.5 years in active treatment / active treatment extension phase. Participants who are nonresponders will advance early to 20 mg Apremilast BID at Week 16.
16213960|NCT01285297|Biological|Bone Marrow Aspirate Concentrate|Injection of up to 18 mL BMAC
16213961|NCT01285284|Other|Music|A previously defined list of songs will be administered by headphones to these patients.
16213962|NCT01285284|Other|No music|No music will be administered by the headphones connected to the MP3 device.
16213963|NCT01285271|Drug|Xenon|gaseous anesthetic, dosage: 50% (v/v) in 50% oxygen, continuous application before the start and after the end of extracorporal circulation
16213964|NCT01285271|Drug|Sevoflurane|inhalative anesthetic, dosage: 1.4% (v/v) in 50% oxygen/medical air , continuous application before the start and after the end of extracorporal circulation
16213965|NCT01285258|Procedure|hysterectomy|excluding the uterus with saving ovaries
16213966|NCT01285245|Drug|kineret|once daily 100 mg of kineret subcutaneously for 8 days
16213967|NCT01285232|Drug|Anakinra|150 mg sc once daily during four weeks
16213968|NCT01285219|Drug|pegylated filgrastim and ﬁlgrastim|patients were administered pegylated filgrastim 100 ug/kg in cycle 1 and ﬁlgrastim 5 ug/kg/d in cycle 2
16213969|NCT01285219|Drug|ﬁlgrastim and pegylated filgrastim|patients received ﬁlgrastim 5 ug/kg/d in cycle 1 and pegylated filgrastim 100 ug/kg in cycle 2
16213970|NCT01285206|Device|Carbon polymer warming blanket|Routine practice ( + no carbon polymer blanket) versus use of HotDog carbon polymer warming blanket throughout day surgery procedure
16213971|NCT01285193|Behavioral|Breath control|A music CD with sound cues is used to guide the subject to breathe in a regular and slower rate. This is practiced for at least 15 minutes a day over 2 months.
16213972|NCT01285180|Drug|Daxas|500 microgram, oral, once daily as add-on therapy to existing therapy
16213973|NCT01285167|Drug|Daxas|500 microgram, oral, once daily as add-on therapy to existing therapy
16213974|NCT01285141|Biological|CN54gp140 glycoprotein-hsp70 conjugate vaccine|CN54gp140-hsp70 conjugate vaccine administered intravaginally 3 times over a 12-week period
16213975|NCT01285115|Drug|Placebo|AC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks.
16213976|NCT01285115|Drug|KyungBangn-Gamisoyosan-x-gwarip|AC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks.
16213977|NCT01285115|Drug|KyungBangn Gamisoyosan|AC 30 min, three times a day each sack taken before or between meals, 7.67g for each sack, 8 weeks.
16213978|NCT01285102|Device|irinotecan-eluting beads|Patients will be treated with drug-eluting irinotecan beads per protocol at up to 100 mg per dose every 3 weeks. Patients will receive chemoembolization using LC Bead, loaded with irinotecan. The beads size range used in the study will be 100-300µm (nominal) with a dose of up to 100mg irinotecan per treatment. The beads will be mixed with a non-ionic contrast media in the vial immediately prior to use according to the instructions for use. Irinotecan will be loaded onto the beads not more than 2 hours prior to the procedure. The study goal will be to deliver the full dose of 100mg of irinotecan per treatment
16213979|NCT01285102|Procedure|hepatic artery embolization|Using a unilateral femoral approach, selective catheterization of the hepatic artery will be performed. Vascular access is obtained via the common femoral artery and a guide-wire advanced under fluoroscopic guidance. A microcatheter is then inserted over the guide-wire. The superior mesenteric artery is selected and an angiogram performed to identify any aberrant arterial anatomy and verify antegrade portal vein flow. The celiac axis is then selected and an angiogram completed. The catheter and guide-wire are used to select the proper hepatic artery and a limited angiogram performed to identify the branches of the hepatic artery. The right or left hepatic artery is selected distal to the cystic artery (if visualized), depending on the location of the lesions to be treated. The LC Bead, loaded with irinotecan will be delivered into the artery.
16213980|NCT01285089|Drug|activated recombinant human factor VII|Data collection of the use of activated recombinant human factor VII observed through real-world treatment practices
16213981|NCT01285076|Other|Other: Retrospective chart review; one participant encounter visit.|Participants will be selected based on medical record review in the office of their treating cardiologist, nephrologist, neurologist, or family practice doctor. Participants will have one encounter visit to fill out questionnaires and have a blood draw and recording of weight, blood pressure and waist circumference.
16213982|NCT01285063|Other|Multidisciplinary intervention: physical activity, dietary instructions and behavioral treatment.|"3 months intervention. Nutritious plan: includes 6 meetings of the child and his or her parents with a dietician from the center.
~Physical activity: physical trainings of 60 minutes each will be held twice a week.
~behavioral treatment: all the participants will take part it a 45 minutes meeting of movement therapy once a week. The goal of such meeting is to strengthen nutritious and physical activity habits and to assimilate positive change in the participants' lifestyle."
16213983|NCT01285050|Drug|Antiretroviral therapy (ART)|Peginterferon alfa-2b administered once as part of a pharmacokinetic study before and after anti-HIV medications. Peginterferon is used to produce a measurement but the intervention is the HIV medications which are specified as raltegravir, emtricitabline, and tenofovir disoproxil fumerate.
16213984|NCT01285050|Drug|raltegravir|raltegravir is an HIV medication given 400 mg twice daily by mouth
16213985|NCT01285050|Drug|Emtricitabine and tenofovir disoproxil fumarate|Emtricitabine and tenofovir disoproxil fumarate are HIV medications, combination pill, once per day by mouth
16213986|NCT01285037|Drug|LY2801653|LY2801653 given orally once daily during 28-day cycles. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met.
16213987|NCT01285037|Drug|Cetuximab|Cetuximab given via IV infusion once weekly, 400mg/m2 for first dose and 250mg /m2 for subsequent doses. If LY2801653 treatment is stopped due to toxicity after a minimum of 4 cycles, cetuximab may be continued until disease progression. In the event cetuximab treatment is stopped, participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met.
16213988|NCT01285037|Drug|Cisplatin|Cisplatin given via IV infusion once a week for 2 weeks and then every 3 weeks. If the LY2801653 is terminated for LY2801653-related toxicity after a minimum of 4 cycles, cisplatin may be continued as monotherapy until progression of disease. Participants discontinuing cisplatin therapy may be allowed to continue single agent LY2801653 if they are receiving clinical benefit.
16213989|NCT01285037|Drug|Gemcitabine|Gemcitabine given via IV infusion once a week for 2 weeks and then every 3 weeks. If the LY2801653 is terminated for LY2801653-related toxicity after a minimum of 4 cycles, gemcitabine may be continued as monotherapy until progression of disease. Participants discontinuing gemcitabine therapy may be allowed to continue single agent LY2801653 if they are receiving clinical benefit.
16213990|NCT01285037|Drug|Ramucirumab|Ramucirumab given via IV infusion every 2 weeks in a 28-day treatment cycle. Treatment with ramucirumab may continue until excessive toxicity or evidence of disease progression. In the absence of disease progression, treatment with LY2801653 may continue even if ramucirumab is discontinued provided no dose limiting toxicity related to LY2801653 is present. In the event that LY2801653 is discontinued, treatment with ramucirumab may be continued if there is no dose limiting toxicity related to ramucirumab.
16213991|NCT01285024|Device|Vitagel|Two 4.5mL Vitagel Surgical Hemostat Kits, used just prior to closing the capsule.
16213992|NCT01284959|Drug|risperidone|risperidone 3mg, PO, 3 times
16213995|NCT01284946|Drug|Exjade|Orodispersible Tablet, 10 mg/Kg/day ± 5 mg/Kg/day during 24 weeks Deferasirox should be taken daily 30 minutes before breakfast
16213996|NCT01284920|Drug|MDV3100|oral
16213997|NCT01284907|Dietary Supplement|Vitamin D3 (Cholecalciferol)|Vit D3 ( Cholecalciferol) 1200 IU oral daily for 6 months
16213998|NCT01284907|Dietary Supplement|Placebo Drops|
16213999|NCT01284894|Device|Conventional manometry|Conventional esophageal manometry
16214000|NCT01284894|Device|High resolution manometry|High resolution esophageal manometry
16214001|NCT01284881|Device|MRA|daily wear overnight
16214002|NCT01284868|Drug|mirabegron|oral
16214003|NCT01284868|Drug|Bisoprolol|oral
16214004|NCT01284868|Drug|propranolol|oral
16214005|NCT01284868|Drug|placebo|oral
16214006|NCT01284855|Drug|Antivenom|Polyvalent antivenom directed against Indian spectacled cobra (N. naja), common Indian krait (B. caeruleus), saw-scaled viper (Echis carinatus) and Russell's viper.
16214007|NCT01284842|Other|24-Hour-Call|one 24-Hour-Call within the regular surgical schedule
16214008|NCT01284829|Other|FDG-PET scan|
16214009|NCT01284816|Procedure|bariatric surgery|The bariatric surgery is a relevant treatment for severely obese patients those with metabolic complications, as it significantly reduces weight, hypertension and ameliorates glycemic control.
16214010|NCT01284803|Behavioral|an educational intervention|To elaborate an educational program for the management of depression in primary care
16214011|NCT01284790|Device|Cochlear implants|
16214012|NCT01284777|Genetic|blood sample, thoracocentesis|20ml of blood only one thoracocentesis (the same that one for diagnostic)
16214013|NCT01284764|Drug|Mosapride|Mosapride 10mg, one dosage, once evening of the day before the endoscopy
16214014|NCT01284751|Other|MDI - self-rating inventory|MDI with 12 questions to be completed approximately 1 week before surgery
16214015|NCT01284738|Other|Physiopathology|"Three sequential biological evaluations will be performed for each patient and will consist in :
~the dosages of MP carried out by the UMR 608 in Marseille,
~the evaluation of the oxidative stress markers and of iron performed in the UMR 773 in Paris-Bichat.
~In vitro production of MP of transfused red blood cells origin will also be evaluated in erythrocytes concentrates during the storage of the units."
16214016|NCT01284738|Other|Physiopathology|"Three sequential biological evaluations will be performed for each patient and will consist in :
~the dosages of MP carried out by the UMR 608 in Marseille,
~the evaluation of the oxidative stress markers and of iron performed in the UMR 773 in Paris-Bichat."
16214017|NCT01284725|Drug|mycophenolate mofetil or azathioprine|
16214018|NCT01284725|Other|immunosuppressive treatment discontinuation|
16214019|NCT01284712|Biological|blood sample|blood sample coming from therapeutic bleeding in hospital
16214020|NCT01284699|Procedure|Gamma Knife radiosurgery|For patients presenting a contraindications for anaesthesia or electrode implantation, operate their brain without opening the skull without infection or bleeding risk.
16214021|NCT01284686|Other|subthalamo-cortical loops stimulation in a one-sided and bipolar way|Record STN-cortex LFP coherence pattern and then stimulate STN (at 0, 5, 10, 15, 20, 25, 30 Hz) in newly implanted patients
16214022|NCT01284686|Other|subthalamo-cortical loops stimulation in a one-sided and bipolar way|Record STN-cortex LFP coherence pattern and then stimulate STN (at 0, 5, 10, 15, 20, 25, 30 Hz) in newly implanted patients
16214023|NCT01284673|Other|in vitro characterization of the cord blood stem cell|The quantitative and qualitative, functional characterization will insist on cell populations which could potentially participate to neuronal regeneration. and assessment such characteristics in conditions of cryo-preservation, compared to fresh cell preparation
16214024|NCT01284660|Dietary Supplement|DHA|DHA ingested orally by heavy smokers
16214025|NCT01284660|Dietary Supplement|Oral ingestion of 5 placebo tablets|Oral ingestion of 5 tablets containing the following: gelatin,glycerine,water and soy oil made by the Solgar Pharmaceutical Co., Israel
16214026|NCT01284647|Drug|Teprenone capsule and placebo of sucralfate|Teprenone 1 capsule (50mg)+placebo of sucralfate 4tab, tid×8 weeks.
16214027|NCT01284647|Drug|Sucralfate and placebo of teprenone|Placebo of teprenone 1 capsule+ sucralfate 4 tab(1.0), tid×8 weeks
16214028|NCT01284634|Drug|GWP42003 200 mg/day Dose|GWP42003 was presented as Licaps® size double zero (Size 00) hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14).
16214029|NCT01284634|Drug|GWP42003 400 mg/day Dose|GWP42003 was presented as Licaps® Size 00 hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14).
16214030|NCT01284634|Drug|GWP42003 800 mg/day Dose|GWP42003 was presented as Licaps® Size 00 hard gelatin capsules containing 100 mg of CBD dissolved in vehicle (Gelucire 44/14).
16214031|NCT01284634|Drug|Placebo|Placebo was presented as Licaps® Size 00 hard gelatin capsules containing excipients (Gelucire 44/14).
16214032|NCT01284621|Drug|BI 10773|medium dose, oral administration
16214033|NCT01284621|Drug|Ramipril|Medium dose oral administration on day 2-5
16214034|NCT01284621|Drug|BI 10773|medium dose oral administration
16214035|NCT01284621|Drug|Ramipril|Low dose oral administration on day 1
16214036|NCT01284621|Drug|Ramipril|Low dose oral administration on day 1
16214037|NCT01284621|Drug|Ramipril|Medium dose oral administration on day 2-5
16214038|NCT01284595|Drug|[14C] AZD8931|Single 160 mg oral dose administered on Day 1
16214039|NCT01284582|Biological|ATH03|4 vaccinations
16214040|NCT01284569|Biological|ALX-0061|Intravenous administration, single dose (0.3-1-3-6-8 mg/kg) or multiple dose (Biologically effective dose, once every 4 weeks or once every 8 weeks, for 24 weeks)
16214041|NCT01284569|Biological|Placebo|Intravenous administration, single dose or multiple dose (once every 4 weeks or once every 8 weeks, for 12(/24) weeks; switch to ALX-0061 in weeks 13-24 if no response after first 12 weeks)
16214042|NCT01284556|Drug|Phenobarbital|tablet
16214043|NCT01284556|Drug|Placebo tablet|tablet
16214044|NCT01284543|Device|Use of the Tan EndoGlide to insert donor graft|Using the Tan EndoGlide to insert donor graft into the eye
16214045|NCT01284543|Device|Busin Glide for delivery of the donor graft|Use of the forceps for delivery of the donor graft into the eye
16214046|NCT01284530|Drug|TPM XR|Equivalent TDD in XR form, QD, Day 1-14
16214047|NCT01284517|Drug|Lurasidone|Tablets 20-120 mg, PM dosing,daily for 6 weeks
16214051|NCT01284491|Device|PEAK PlasmaBlade 4.0|The PEAK PlasmaBlade will be used for the entirety of the operation, including the skin incision.
16214052|NCT01284491|Device|Traditional Electrosurgery with scalpel|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
16214053|NCT01284478|Drug|Dexamethasone Implant|Ozurdex (Dexamethasone Implant), 0.7 mg will injected intravitreally
16214054|NCT01284465|Behavioral|Education and patient liaison combination|Group education sessions with Patient liaison using ecological momentary assessment principles
16214055|NCT01284465|Behavioral|Control group|Group education sessions at baseline, 3 and 6 months
16214056|NCT01284452|Drug|Placebo|Normal saline 50 ml intravenous every 6 hours for 7 days
16214057|NCT01284452|Drug|Hydrocortisone|Hydrocortisone 50 mg intravenous every 6 hours for 7 days
16214058|NCT01284439|Drug|hydroxypropylmethylcellulose|TearA: QID to every 2 hous , 1-2 drops per each time , duration 1 month
16214059|NCT01284439|Drug|sodium hyaluronate|QID to every 2 hous, 1-2 drops per each time, duration 1 month
16214060|NCT01284413|Drug|S-1, Gemcitabine, Cisplatin|S-1 is given daily for 7 consecutive days and gemcitabine and cisplatin are infused on day1. The cycle is repeated every 2 weeks.
16214061|NCT01284400|Other|Home-based disease management|Symptom monitoring, comprehensive advice, and counseling at home by nurses, as well as telephone follow-up by nurses
16214062|NCT01284387|Biological|ACC-001 (vanutide cridificar)|Comparisons of 2 different doses of ACC-001 or placebo for 24 months
16214063|NCT01284361|Device|30 cm Intermittent Catheter|Randomized cross-over
16214064|NCT01284361|Device|40 cm Intermittent Catheter|randomized cross-over
16214065|NCT01284348|Drug|Sotatercept 15 mg|Sotatercept 15 mg SC injection every 42 days, up to 4 doses/cycles
16214066|NCT01284348|Drug|Sotatercept 30 mg|Sotatercept 30 mg subcutaneous injection Day 1 every 42 days, up to 4 doses/cycles
16214067|NCT01284335|Drug|Gemcitabine|1000 mg/m2 administered intravenously on Days 1 and 15 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
16214068|NCT01284335|Drug|Docetaxel|60 mg/m2 administered intravenously over 60 minutes on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
16214069|NCT01284335|Drug|Temozolomide|200 mg/m2 administered orally on days 1-5 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
16214070|NCT01284335|Drug|Cisplatin|75 mg/m2 administered intravenously on Day 1 of the 28-day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
16214071|NCT01284335|Drug|Erlotinib|150 mg administered orally days 1-28 of a 28 day cycle until disease progression, unacceptable toxicity or other discontinuation criteria are met.
16214072|NCT01284335|Drug|LY573636|Individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28 day cycle. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
16214073|NCT01284322|Drug|Fresolimumab|intravenous fresolimumab 1mg/kg, first 8 patients; 5 mg/kg following 8 patients
16214074|NCT01284309|Drug|Mirabegron|oral
16214075|NCT01284309|Drug|Placebo|oral
16214076|NCT01284296|Drug|Lidocaine digital block|One dose of lidocaine 2% injected locally into one finger (2 mls total)
16214077|NCT01284296|Device|Masimo SpHb continuous hemoglobin monitor|Masimo SpHb continuous hemoglobin monitor
16214078|NCT01284283|Device|Scandinavian Total Ankle Replacement System (STAR Ankle)|For total ankle replacement
16214079|NCT01284270|Other|Cardiac MRI|Cardiac MRI
16214080|NCT01284244|Device|Uresta pessary|Participants randomized to the Uresta group will be fitted with device before immediately before performing the pad test. The Uresta pessary is made of medical grade rubber that has been extensively tested for safety. It is bell-shaped, with a narrow tip that allows for easy insertion into the vagina in a similar fashion to a tampon. The device can be easily inserted, and removed by a patient for use when needed. The Uresta comes in 3 sizes. Fitting starts with insertion of the smallest size. If urine leakage continues with valsalva or a cough stress test, it can be replaced by one size larger, until leakage is stopped. If the device prevents the patient from being able to void or is uncomfortable due to its size, the smaller size is replaced. Following the pad test, the participant will be given the opportunity to keep the device for continued use, or remove it if desired.
16214081|NCT01284244|Device|Silastic ring|The silastic ring is a plastic flexible ring similar to that used to administer vaginal estrogen (Estring). It is well tolerated and would not contain any medications. Immediately before performing the pad test, it would be placed high in the vagina, away from the urethra. It would be removed immediately after the pad test. Draping will conceal from the patient which device was inserted.
16214082|NCT01284231|Drug|MEDI-565|MEDI-565 will be administered by IV infusion
16214083|NCT01284231|Drug|MEDI-565|20 subjects with selected gastrointestinal tumor type to receive MEDI-565 at the maximum tolerated dose or optimum biologic dose by IV infusion over 3 hours per day for 5 consecutive days every 28 days.
16214084|NCT01284231|Drug|MEDI-565|20 subjects with selected gastrointestinal tumor type to receive MEDI-565 at the maximum tolerated dose or optimum biologic dose by IV infusion over 3 hours per day for 5 consecutive days every 28 days.
16214085|NCT01284231|Drug|MEDI-565|20 Subjects with refractory Gastroesophageal cancer to receive MEDI-565 at the maximum tolerated dose or optimum biologic dose by IV infusion over 3 hours per day for 5 consecutive days every 28 days.
16214086|NCT01284205|Biological|Mycobacterial Cell-Wall DNA Complex|8 mg/50 mL (sterile WFI) Intravesical Administration; one weekly instillation per week for 6 week Induction Phase; three weekly instillations per month at Months 3, 6, 12, 18, and 24 followed by Maintenance Phase.
16214087|NCT01284205|Biological|Bacillus Calmette-Guerin|mg/50 mL (sterile saline) Intravesical Administration; one weekly instillation per week for 6 week Induction Phase; three weekly instillations per month at Months 3, 6, 12, 18, and 24 followed by Maintenance Phase.
16214088|NCT01284192|Drug|ASP3026|Tablet
16214129|NCT01283919|Drug|Pantoprazole Sodium|Pantoprazole Sodium DR Tablets 40 mg
16214130|NCT01283906|Device|MuGard|Mucoadhesive Oral Wound Rinse. 5 mL oral rinse is used to cover the entire oral cavity every 3 hours (while awake) for up to a maximum of 6 doses per day
16214089|NCT01284179|Behavioral|Home Hypnotherapy|Each session contains the following elements: (1) trance induction consisting of narrowing the focus of attention and eye-closure, (2) trance deepening through imagery, guided dissociation from the here-and-now and graded suggestions of change in mental state, (3) vivid guided imagery that engages all the senses and implies improved health, well-being and a sense of strength and personal power, (4) therapeutic suggestions and imagery, both direct and indirect, for enhanced chest comfort, overall physical comfort and mental well-being and immunity to discomfort, that is suggested will last beyond termination of the session and become more noticeable and permanent over time, and (5) trance termination through direct suggestions and counting.
16214090|NCT01284179|Behavioral|Educational|Educational recordings regarding FCP and FGIDs.
16214091|NCT01284166|Drug|dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution|1 drop of Triple Combination Therapy (dorzolamide hydrochloride 2.0%/brimonidine tartrate 0.2%/timolol 0.5% ophthalmic solution) administered to each eye, twice daily for 12 weeks.
16214092|NCT01284140|Behavioral|Sleep and circadian rhythm promotion|This multifaceted intervention attempts to enhance sleep and circadian rhythmicity through improved scheduling of nursing procedures, enforcement of a day/night routine, increased light exposure during the day, and decreased light and sound exposure during the night. The intervention began the morning after enrollment and enforced a specific period of enhanced light exposure from 9:00 a.m. to noon. The initial target of 5,000 lux administered by light box (Sunsation, SunBox Co.) was reduced to 400-700 lux after the first 10 subjects were enrolled in the study.
16214093|NCT01284140|Behavioral|Usual care|Usual care.
16214094|NCT01284114|Drug|Aliskiren|150mg/day for all as initial dose, 300mg/day for the patients that still show hypertension(above 140/90mmHg)after one month 150mg treatment,oral,on 6 months
16214095|NCT01284101|Device|Use of the Tan Endoglide to insert the donor graft|Using the Tan Endoglide to insert the donor graft into the eye
16214096|NCT01284101|Device|Forceps for delivery of the donor graft|Use of the forceps for delivery of the donor graft into the eye.
16214097|NCT01284088|Device|PrePex™ device for adult male circumcision|The PrePex™ device is designed to enable bloodless male circumcision procedure with no anesthesia and no sutures.
16214098|NCT01284088|Procedure|Surgical circumcision|The penis will be surgically circumcised according to one of the WHO recommended circumcision methods as described in the Manual for Male Circumcision under Local Anaesthesia Version 2.5C January 2008
16214099|NCT01284075|Behavioral|Guided imagery and music therapy|Participants will undergo a standardized regimen of peri-operative guided imagery and music therapy guided by CDs (compact disc). The peri-operative regimen will include: listening to the CD while in the pre-operative holding area, listening to the CD during the procedure; listening to the CD after the procedure beginning on the evening of post-operative day (POD)#0 and continuing twice a day until POD#3.
16214100|NCT01284075|Behavioral|White Noise|Control group (WN) will listen to a CD with white noise. Participants' regimen will include: listening to the CD while in the pre-operative holding area, listening to the CD during the procedure; listening to the CD after the procedure beginning on the evening of post-operative day (POD)#0 and continuing twice a day until POD#3.
16214101|NCT01284075|Other|No intervention|Control group (CP) will have no intervention at all and will follow our current peri-operative procedures.
16214102|NCT01284062|Biological|Anrukinzumab|200 mg sterile liquid vial, administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
16214103|NCT01284062|Biological|Anrukinzumab|200 mg sterile liquid vial, dose level 400 mg administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
16214104|NCT01284062|Biological|Anrukinzumab|200 mg sterile liquid vial, dose level 600 mg administered intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12 Note: dosing in the 600 mg arm will be delayed until the safety of the 200 mg and 400 mg arms has been reviewed.
16214105|NCT01284062|Other|placebo|200 mg liquid sterile vial, administered at matching dose level 200 mg, 400 mg or 600 mg intravenously, one-hour infusion on Day 1, Week 2, 4, 8, and 12
16214106|NCT01284049|Drug|Intralipid 20%®|Administration of Intralipid 20%® at a dose ranging between 0.5 and 1 g/kg/infusion during 12 weeks.
16214107|NCT01284049|Drug|OMEGAVEN 10%®|OMEGAVEN 10%® will be used as the sole lipid supplement at a dose of 0.5 to 1.0 g/kg/Infusion with a maximum dose per infusion of 40 grams, in view of formulation constraints during 12 weeks.
16214108|NCT01284036|Drug|PF-05230905|Single dose subcutaneous or intravenous (IV) administration of PF-05230905 or placebo
16214109|NCT01284023|Other|Shaving|Male patients will have the leg hair under each sensor site shaved, using an electric razor, and near infrared spectroscopy monitored for an additional 15 minutes
16214110|NCT01284010|Genetic|DNA analysis|
16214111|NCT01284010|Genetic|fluorescence in situ hybridization|
16214112|NCT01284010|Genetic|gene expression analysis|
16214113|NCT01284010|Genetic|microarray analysis|
16214114|NCT01284010|Genetic|mutation analysis|
16214115|NCT01284010|Genetic|polymerase chain reaction|
16214116|NCT01284010|Other|laboratory biomarker analysis|
16214119|NCT01283984|Drug|AZD2115|Single dose, oral inhalation (nebuliser solution)
16214120|NCT01283984|Drug|Placebo|Single dose, oral inhalation (nebuliser solution)
16214121|NCT01283971|Drug|tocilizumab [RoActemra/Actemra]|Tocilizumab 8 mg/kg IV every 4 weeks for 24 weeks.
16214122|NCT01283971|Drug|adalimumab|Adalimumab 40 mg SC every 2 weeks.
16214123|NCT01283971|Drug|placebo to tocilizumab|Placebo to tocilizumab IV every 4 weeks for 24 weeks.
16214124|NCT01283971|Drug|placebo to adalimumab|Placebo to adalimumab SC every 2 weeks for 24 weeks.
16214125|NCT01283971|Drug|methotrexate|Methotrexate 10-25 mg weekly.
16214126|NCT01283971|Drug|folate|Folate at least 5 mg weekly.
16214127|NCT01283945|Drug|Lucitanib|"Oral administration, once daily (qd), in fasting conditions.
~Dose escalation - continuous schedule
~Dose expansion - continuous or intermittent dosing schedules (i.e. 5 days on/2days off or 21 days on/7 days off)
~Dosage form: hard gelatin capsules for oral administration (2.5, 5, 10, 30 and 50 mg strengths)"
16214128|NCT01283932|Drug|Pantoprazole Sodium|Pantoprazole Sodium DR Tablets 40 mg
16214131|NCT01283906|Device|Control Rinse|Aqueous Control Rinse. 5 mL oral rinse is used to cover the entire oral cavity every 3 hours (while awake) for up to a maximum of 6 doses per day.
16214132|NCT01283893|Procedure|Laparoscopic distal gastrectomy with D2 lymphadenectomy|The commonly practice laparoscopic surgery for gastric cancer involves a partial omentectomy+D1+b lymphadenectomy which includes the dissection of Lymph node stations 1, 3, 4, 5, 6, 7, 8a, 9; however, when performing a D2 lymph node dissection, a total omentectomy plus LN1, 3, 4, 5, 6, 7, 8a, 9, 12a retrieval will be completed. The same total omentectomy+D2 lymphadenectomy will also be performed by the open method.
16214133|NCT01283867|Drug|Mycophenolate Mofetil|Mycophenolate Mofetil 500 mg tablets
16214134|NCT01283854|Behavioral|Supervised home-based exercise|"Each participant randomised to the exercise group will be required to participate in three 60-minute exercise sessions each week, starting at 14 weeks gestation, for a total of 14 weeks (i.e. to be completed by 28 weeks of gestation). All exercise sessions will be home-based and fully supervised by an experienced exercise physiologist. The exercise program will be implemented in accordance with the American College of Sports Medicine and the American College of Obstetrics and Gynecology guidelines. All sessions will be conducted on a stationary cycle ergometer.
~Heart rate will be measured continuously during exercise to ensure that the exercise intensity is maintained as prescribed. In addition, blood pressure and rate of perceived exertion will be monitored at 10-min intervals. Perceived exertion will not be allowed to exceed a rating of 14 (i.e. somewhat hard)."
16214135|NCT01283841|Drug|Mycophenolate Mofetil|Mycophenolate Mofetil 500 mg tablets
16214136|NCT01283815|Procedure|Laparoscopic appendectomy|Laparoscopic appendectomy and laparoscopic drainage of the abscess. If appendectomy is not possible due to technical difficulties only laparoscopic drainage is performed. Patients are treated with the same antimicrobial therapy as the control group (intravenous Cefuroxime 1,5 g x 3 per day plus Metronidazole 500 mg x 3 per day).
16214137|NCT01283815|Procedure|Conservative management with percutaneous drainage|Patients are treated with intravenous Cefuroxime 1,5 g x 3 per day plus Metronidazole 500 mg x 3 per day. If the abscess is at least 3 cm in diameter percutaneous ultrasound guided drainage is performed.
16214138|NCT01283802|Procedure|INTRAOPERATIVE CHOLANGIO-ULTRASOUND|"Techniques are as follows:
~Direct ultrasound exploration without any contrast agents.
~IOCUS injection into the bile duct of a mixture of air and saline (2 parts water and 1 part air);
~IOCUS injection of an air bolus into the bile duct."
16214139|NCT01283789|Drug|Lapatinib and RAD-001|"Lapatinib will be taken orally as a once-daily dose of 1250 mg (five 250 mg tablets) continuously from study day 1 until progression of disease. Patients will take the tablet at bedtime, at the same time each day, in a fasting state.
~Everolimus will be taken orally as a once-daily dose of 5 mg (one 5 mg tablet) from study day 1 until progression of disease. Patients will take the tablet at the same time each morning."
16214140|NCT01283776|Drug|Cyclophosphamide|100 mg/kg total dose, infused on day +3 and +3 after allogeneic stem cell transplantation
16214141|NCT01283763|Drug|Topical Imiquimod|16 weeks
16214142|NCT01283763|Procedure|Conization|Large loop excision of the transformation zone
16214143|NCT01283750|Behavioral|care coordination|dementia-related care coordination
16214144|NCT01283737|Device|DBX Putty|OCD of the knee will be treated with DBX Putty
16214145|NCT01283737|Procedure|Mosaicplasty|Mosaicplasty procedure performed to treat OCD of the knee
16214146|NCT01283724|Drug|Dienogest (Visanne, BAY86-5258)|Subjects received Dienogest tablet orally at a dosage of 2 mg once daily over a period of 52 weeks.
16214147|NCT01283711|Device|apollo device|RF treatments for wrinkles and rhytides reduction
16214148|NCT01283698|Drug|Experimental: LAS 41004 dosage 1|dosage 1, once daily
16214149|NCT01283698|Drug|Experimental: LAS 41004 dosage 2|LAS 41004 dosage 2, once daily
16214150|NCT01283698|Drug|Experimental: LAS 41004 dosage 3|dosage 3, once daily
16214151|NCT01283698|Drug|Placebo Comparator: placebo|once daily
16214152|NCT01283698|Drug|Reference|Active Comparator,once daily
16214153|NCT01283685|Other|breathing helium-hyperoxia|40% O2, 60% He
16214154|NCT01283685|Other|breathing supplemental oxygen|oxygen (4 L/min) provided by nasal cannula
16214155|NCT01283672|Other|Controlled diet with whole grain barley, whole grain oats, or low grain diet|Participants will consume a standardized diet for 3 days prior to the treatment intervention meal. Meals will be prepared using traditional American foods with a macronutrient composition representative of a typical American diet. Participants will be instructed to eat all foods and only foods provided to them, with the exception of water, coffee, tea, and diet soda.
16214156|NCT01283659|Other|Standard Imaging|
16214157|NCT01283659|Other|Advanced Imaging|
16214158|NCT01283646|Drug|Apevitin BC|3.5 to 5 ml 3 times a daily
16214159|NCT01283646|Drug|Vitamin B Complex + Vitamin C|3.5 to 5 ml 3 times a daily
16214160|NCT01283633|Device|Neuromodulation|Neuromodulation as directed via remote presence robotic and experienced clinician for those with neuromodulation systems implanted to treat movement disorders and chronic pain
16214161|NCT01283620|Behavioral|modified constraint induced movement therapy (mCIMT)|The intervention group will receive usual care plus mCIMT. mCIMT consists of two components delivered in parallel: three 30 min therapy sessions/week focusing on progressively more difficult tasks performed with the arm/hand, and five hours/weekday of restraint of the unaffected upper limb. Each 30 min therapy session consists of using the affected upper limb in practicing 4-5 functionally relevant tasks.
16214162|NCT01283620|Other|Usual and Customary Care|Patients in this arm will receive usual care dose-matched to the experimental care group. Usual care will consist of occupational and physiotherapy intervention focused on affected upper limb range of motion (i.e., active range of motion incorporated into functional tasks such as reaching), strengthening (i.e., upper limb resisted exercise), manual dexterity exercises (i.e., grasp and release, stacking cones), and general aerobic conditioning (i.e., recumbent stepper, treadmill).
16214163|NCT01283607|Behavioral|Digicoach|Digicoach is an e-health cognitive behavioral therapy with 4-12 weekly sessions especially developed for IVF women. Digicoach is facilitated by an e-therapist. The investment for the weekly home work assignments is about one and a half hour. Digicoach consist of different modules (e.g. stress reduction, acceptance). Digicoach starts before the hormonal down regulation as the start of the IVF procedure and ends three weeks after the pregnancy test.
16214307|NCT01282398|Drug|Simvastatin|The experimental group will take 40 mg each 24 hours for at least two years.
16214164|NCT01283594|Drug|Tozadenant (SYN115) 60 mg BID|"Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
~Total daily doses include 60 mg BID."
16214165|NCT01283594|Drug|Placebo|White-coated, modified-oval placebo tablets.
16214166|NCT01283594|Drug|Levodopa (L-dopa)|One intravenous infusion of L-dopa to reach approximately 600 ng/ ml plasma concentration.
16214167|NCT01283594|Drug|Tozadenant (SYN115) 120 mg BID|"Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
~Total daily doses include 120 mg BID."
16214168|NCT01283594|Drug|Tozadenant (SYN115) 180 mg BID|"Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
~Total daily doses include 180 mg BID."
16214169|NCT01283594|Drug|Tozadenant (SYN115) 240 mg BID|"Tozadenant tablets, white-coated, modified-oval tablets manufactured in 60 mg dosage strengths.
~Total daily doses include 240 mg BID."
16214170|NCT01283581|Drug|Delafloxacin|300mg IV every 12 hours for 5-14 days
16214171|NCT01283581|Drug|Linezolid|600mg IV every 12 hours for 5-14 days
16214172|NCT01283581|Drug|Vancomycin|15mg/kg, up to 1250 mg, IV every 12 hours for 5-14 days
16214173|NCT01283555|Drug|Tenofovir|Delivered using prefilled and user-filled applicator
16214174|NCT01283542|Drug|Pasireotide LAR|20 and 40 mg of powder in vials and 2 mL of vehicle in ampoules (for reconstitution) administered as a depot intragluteal IM (intramuscular) injection
16214175|NCT01283516|Drug|LDK378|LDK378 is a selective and a potent inhibitor of anaplastic lymphoma kinase (ALK) activity, is a capsule and is administered orally.
16214176|NCT01283503|Drug|BKM120|
16214177|NCT01283490|Device|DASD Group|Single application of 20% Benzocaine applied for one minute with the DASD ultrasonic and sonic vibration prior to needle puncture.
16214178|NCT01283490|Device|Sonic Vibration (SV)|Single application of 20% benzocaine applied with SV for one minute prior to needle puncture.
16214179|NCT01283477|Device|ACUPUNCTURE AT LI11|ACUPUNCTURE AT LI11 FOR 30 MINUTES PRIOR TO INTRATHECAL MORPHINE & LEFT IN PLACE FOR 30 MINUTES
16214180|NCT01283477|Device|SHAM ACUPUNCTURE|SHAM ACUPUNCTURE AT A POINT 2 CM LATERAL TO LI11 30 MINUTES PRIOR TO INTRATHECAL MORPHINE & LEFT IN PLACE FOR 30 MINUTES
16214181|NCT01283464|Drug|Retinol|1.0% cream
16214182|NCT01283464|Drug|Tretinoin|0.02% cream
16214183|NCT01283451|Behavioral|Muscle contraction|Participants will perform a 30-60 second exercise designed to cause a temporary decrease in muscle oxygenation of a specific muscle group.
16214184|NCT01283438|Device|Barricaid|Annular closure device
16214185|NCT01283438|Device|Standard of Care|Standard Limited discectomy
16214186|NCT01283425|Device|InsuPatch|Heaters for single use and a permanent control unit.
16214187|NCT01283412|Drug|Placebo|Placebo (saline) iv. during the operation and stoped 30min before end of the surgery
16214188|NCT01283412|Drug|Dexmedetomidine|Dexmedetomidine 0.1~0.2ug/kg/h iv. during the operation, and stoped 30min before end of surgery
16214189|NCT01283386|Drug|Chlorambucil|10 mg/m^2 orally on Days 1-7 of each 28-day cycle for 6 cycles
16214190|NCT01283386|Drug|Cyclophosphamide|150 mg/m^2 IV or orally on Days 1-3 of each 28-day cycle for 6 cycles
16214191|NCT01283386|Drug|Fludarabine|20 mg/m^2 IV or 32 mg/m2 orally Days 1-3 of each 28-day cycle for 6 cycles
16214192|NCT01283386|Drug|Rituximab|375 mg/m2 IV on Day 1 of Cycle 1; 500 mg/m2 IV on Day 1 of Cycles 2-6 (28-day cycles)
16214193|NCT01283373|Drug|DSTP3086S|DSTP3086S administered intravenously
16214194|NCT01283373|Drug|DSTP3086S|Escalating intravenous dose
16214195|NCT01283360|Other|HEC Placebo Gel|The HEC universal placebo gel for Stage 2 will be supplied by CONRAD (Arlington, VA, USA). Under direction from CONRAD, DPT Laboratories will manufacture the HEC placebo gel and analyze/release the gels under cGMP. DPT Laboratories will fill the applicators with HEC placebo gel to create pre-filled applicators and package each applicator and plunger in a wrapper. Each pre-filled applicator will contain and deliver a dose of approximately 4 mL of HEC gel.
16214196|NCT01283360|Drug|Tenofovir 1% Gel|Tenofovir 1% gel will be supplied by CONRAD (Arlington, VA, USA). Under direction from CONRAD, DPT Laboratories will manufacture the tenofovir 1% gel and analyze/release the gels under cGMP. DPT Laboratories will fill the applicators designed for vaginal use with tenofovir 1% gel to create pre-filled applicators and package each applicator and plunger in a wrapper. Each pre-filled applicator will contain and deliver a dose of approximately 4 mL of tenofovir 1% gel (equal to 4.4 g).
16214197|NCT01283347|Drug|18F-DTBZ|"During this study, subjects will receive a single i.v. administration of approximately 10 mCi 18F-FP-(+)-DTBZ immediately prior to imaging.
~The proposed dose for this study is based on our phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG"
16214198|NCT01283334|Drug|Carboplatin|Will be given as a 30 minutes intravenous (IV) infusion on days 1, 8, and 15 of each 28 day cycle. The starting dose of carboplatin will be area under the plasma-concentration time curve (AUC) = 2 mg/ml.min. Appropriate dose reductions will be done for toxicity for subsequent cycles.
16214199|NCT01283334|Drug|Cetuximab|Will be given on days 1, 8, 15 and 22 of each 29 day cycle. On week 1, a loading dose of 400 mg/m² will be given. From week 2 onwards, the dose of cetuximab will be 250 mg/m².
16214200|NCT01283334|Drug|RAD001|For phase I, dose escalation will be 2.5 mg, 5 mg, 7.5 mg or 10 mg given orally on a daily basis.
16214201|NCT01283321|Drug|Human fibrinogen concentrate|4 g IV once, within 30 minutes of ACT < 155 seconds, post CPB, with evidence of significant microvascular bleeding
16214202|NCT01283321|Other|apheresis platelets|A single apheresis platelet unit will be administered as an initial therapy within 30 minutes of ACT <155 seconds post CPB with evidence of significant microvascular bleeding.
16214241|NCT01283009|Drug|Inactive Substance|Inactive Substance will be given in a double-blind fashion for 20 full days. The treatment course includes a bolus dose on the day of randomization, 7 days of full dose (40 mg/day), 7 days of half dose (20 mg/day), and 6 days of tapering doses (12 mg/day and 4 mg/day).
16214242|NCT01283009|Drug|Methylprednisolone|Methylprednisolone will be given in a double-blind fashion for 20 full days. The treatment course includes a bolus dose on the day of randomization, 7 days of full dose (40 mg/day), 7 days of half dose (20 mg/day), and 6 days of tapering doses (12 mg/day and 4 mg/day).
16216394|NCT01266174|Drug|Placebo|Placebo to match eltoprazine
16214203|NCT01283308|Behavioral|Lifestyle Intervention|Intervention arm participants will attend 6 months of weekly classes where they will be taught the skills necessary to reach these goals. The curriculum for the classes is based on the DPP lesson plans. Social support will be provided by trained lay health educators and peer support groups. Participants who remain at highest risk of T2DM after four or more months in the program will be prescribed metformin in addition to continuing the lifestyle program. Metformin dosages will start at 500 mg per day, and, when appropriate, will increase to 1000 mg per day (given as 500 mg twice per day). This group will be comprised of individuals who have (1) Fasting plasma glucose values of 100 mg/dl or more and (2) elevated fasting HbA1c measures of 5.7% or more.
16214204|NCT01283308|Behavioral|Standard of Care|Participants randomized to the standard of care group will meet with a physician and a dietician, attend one class/awareness lecture on diabetes prevention through weight loss and diet change and one class on exercise, and receive handouts reinforcing what they learn in class and with the dietician, fitness consultant, and physician.
16214205|NCT01283282|Drug|Clopidogrel|Clopidogrel 75 mg PO qday for 6 weeks
16214206|NCT01283282|Drug|Placebo|Placebo PO qday for 6 weeks
16214207|NCT01283269|Behavioral|Memory Support System|Training in use of a memory notebook system
16214208|NCT01283269|Behavioral|Computer Training|Computer brain fitness training
16214209|NCT01283256|Drug|zonisamide|zonisamide 100mg tablets
16214210|NCT01283243|Device|Acoustic radiation force impulse imaging|Acoustic radiation force impulse (ARFI) imaging were measured 10 times in each patient.The region of interest was chosen in an area where the normal liver parenchyma was at least 6 cm thick and free of large blood vessels was chosen. A measurement depth of 2 cm below the liver capsule was chosen to standardize the examination.
16214211|NCT01283230|Device|Acoustic radiation force impulse imaging|Acoustic radiation force impulse (ARFI) imaging were measured 10 times in each patient.The region of interest was chosen in an area where the normal liver parenchyma was at least 6 cm thick and free of large blood vessels was chosen. A measurement depth of 2 cm below the liver capsule was chosen to standardize the examination.
16214212|NCT01283217|Drug|DS|Docetaxel with S-1. S-1: Orally, within 30 minutes after ingestion of food. Docetaxel and Cisplatin: IV infusion.
16214213|NCT01283217|Drug|SP|S-1 with cisplatin. S-1 : Orally, within 30 minutes after ingestion of food. Docetaxel and Cisplatin: IV infusion.
16214214|NCT01283204|Drug|SP|"<Every 3 weeks>
~Day 1~14 : TS-1 80mg/m2/day (PO),
~Day 1 : CDDP 60mg/m2/day IVF 2hours,
~Day 15~21 : Rest."
16214215|NCT01283204|Drug|FL/Tax|"<Every q 3 weeks>
~Day1 : Paclitaxel 175mg/m2 IVF for 2hours
~Day1 : Leucovorin 20mg/m2 IVF for 1hour
~Day1~3 : 5-FU 1000mg/m2 IVF for 24hours"
16214216|NCT01283204|Drug|FL/Doc|"<Every q 3 weeks>
~Day1 : Docetaxel 75mg/m2 IVF for 1hour
~Day1 : Leucovorin 20mg/m2 IVF for 1hour
~Day1~3 : 5-FU 1000mg/m2 IVF for 24hours"
16214217|NCT01283204|Drug|FOLFOX|<Every q 2 weeks> D1 : Oxaliplatin 100mg/m2 IVF for 2hours D1 : Leucovorin 20mg/m2 IVF for 1hour D1 : 5-FU 400mg/m2 IV bolus D1~2 : 5-FU 1200mg/m2 IVF for 24hours
16214218|NCT01283191|Behavioral|Behavioral Incentives|Vouchers for complying with target behavior of treadmill walking
16214219|NCT01283191|Behavioral|Education Control|Education class
16214220|NCT01283178|Radiation|intensity-modulated radiation therapy|Undergo intensity-modulated image-guided adaptive radiotherapy
16214221|NCT01283178|Drug|cisplatin|Given IV
16214222|NCT01283178|Radiation|image-guided adaptive radiation therapy|Undergo intensity-modulated image-guided adaptive radiotherapy
16214223|NCT01283178|Other|3'-deoxy-3'-[18F]fluorothymidine|Undergo FLT-PET scans for IMRT/IGART
16214224|NCT01283178|Procedure|positron emission tomography/computed tomography|Undergo FDG/FLT-PET scans for IMRT/IGARTT
16214225|NCT01283178|Radiation|fludeoxyglucose F 18|Undergo FDG-PET scans for IMRT/IGART
16214226|NCT01283165|Behavioral|Health education intervention|Health education was conducted in two ways. (1) Teachers were taught how to use the flip chart that contained health education material about parasites. The lessons were done during free periods as this intervention had not been formally fitted into the school syllabus. (2) The research team provided health education to school children. Focus group discussions were conducted by the research team with school children all assembled outside their classes. Health education leaflets were distributed to all school children at the school. Children were asked to share the health information with their friends and families.
16214227|NCT01283152|Drug|Polyethylene glycol 3350-electrolyte solution (GoLYTELY®)|If randomized to this arm, subjects will receive a 1 time dose of 1 gallon
16214228|NCT01283152|Drug|Lactulose|If randomized to this arm, subjects will receive 10-30 grams per standard of care
16214229|NCT01283139|Biological|Sifalimumab 200 mg|Sifalimumab 200 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses.
16214230|NCT01283139|Biological|Sifalimumab 600 mg|Sifalimumab 600 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses.
16214231|NCT01283139|Biological|Sifalimumab 1,200 mg|Sifalimumab 1,200 mg intravenously every 2 weeks for 4 weeks and then monthly for 44 weeks for a total of 14 doses.
16214232|NCT01283139|Other|Placebo|IV Placebo every 2 weeks for 4 weeks and then monthly for 44 weeks
16214233|NCT01283126|Procedure|euglycemic and hypoglycemic clamp|Subjects will undergo standard euglycemic and hypoglycemic clamps, and will have concurrent assessments of cognitive function and measurement of interstitial glucose concentrations.
16214234|NCT01283100|Drug|GSK1349572|50mg once every 24 hours for 7 days
16214235|NCT01283100|Drug|GSK2248761|200 mg once every 24 hours for 7 days
16214236|NCT01283061|Drug|Zafirlukast|Zafirlukast tablets 20 mg
16214237|NCT01283048|Drug|BKM-120 Bevacizumab|BKM-120 60, 80, 100 mg PO QD Bevacizumab 10 mg/Kg every 2 weeks
16214238|NCT01283035|Drug|Akt Inhibitor MK2206|Given PO
16214239|NCT01283035|Other|Laboratory Biomarker Analysis|Correlative studies
16214240|NCT01283022|Drug|MVI 200|Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
16214243|NCT01282996|Other|Abdominal surgery|to compare the influence of a lung protective ventilation with conventional ventilation on postoperative complications following major abdominal surgery
16214244|NCT01282983|Dietary Supplement|Fiber|The study consists of 21 days consumption of Orange juice. The volunteers will be instructed to consume 200ml of juice twice a day (1 pack of 200ml at lunch and one at dinner) with 4grams of fiber in each pack.
16214245|NCT01282983|Dietary Supplement|Placebo|The study consists of 21 days consumption of Orange juice. The volunteers will be instructed to consume 200ml of juice twice a day (1 pack of 200ml at lunch and one at dinner) without fiber.
16214246|NCT01282970|Drug|BI 135585|oral doses given to approximately 5-6 parallel groups of 12 subjects (9 on active and 3 on placebo) over 14 days
16214247|NCT01282970|Drug|Placebo to BI 135585|oral doses given to approximately 5-6 parallel groups of 12 subjects (9 on active and 3 on placebo) over 14 days
16214248|NCT01282957|Behavioral|Financial Incentive Group I|Lottery with 1 in 100 odds of $100 and 18 in 100 odds of $10. The intervention involves the daily lottery itself along with feedback via email or text messaging to participants about the lottery results and whether or not they were included based on device adherence.
16214249|NCT01282957|Behavioral|Financial Incentive Group II|Lottery with 1 in 100 odds of $50 and 18 in 100 odds of $5. The intervention involves the daily lottery itself along with feedback via email or text messaging to participants about the lottery results and whether or not they were included based on device adherence.
16214250|NCT01282944|Behavioral|Financial Incentive|Lottery with an approximate 3 in 10 odds of earning $50 and an approximate 3 in 100 odds of earning $200.
16214251|NCT01282944|Behavioral|Peer Network|Subjects will be connected with 4 other participants in the same study arm to form a peer network of 5 individuals.
16214252|NCT01282918|Device|ICD implantation w/o DF test|ICD implantation without Defibrillation Test
16214253|NCT01282918|Device|ICD implantation with DF test|ICD implantation with DF test according to standardized procedure
16214254|NCT01282892|Procedure|excess of visceral fat|excess of visceral fat
16214255|NCT01282892|Procedure|patients with NAFLD|patients with NAFLD
16214256|NCT01282879|Drug|Itraconazole|200mg bid, oral solution, until a dose of prednisone was tapered to 10mg/day in case of prednisone alone therapy group, or until prednisone was stopped in case of CNIs plus prednisone, CNIs plus prednisone plus mycophenolate mofetil, or mycophenolate mofetil plus prednisone group, etc.
16214257|NCT01282866|Device|LightSheer Duet|LightSheer Duet HS handpiece
16214258|NCT01282853|Procedure|endoscopic biopsy|endoscopic biopsy for rapid urease test
16214259|NCT01282853|Procedure|endoscopic biopsy|endoscopic biopsy for rapid urease test
16214260|NCT01282853|Procedure|endoscopic biopsy|endoscopic biopsy for rapid urease test
16214261|NCT01282840|Drug|Tolterodine SR|Tolterodine SR 4 mg qd
16214262|NCT01282827|Device|rtACS (verum condition)|Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000 microA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation.
16214263|NCT01282827|Device|placebo stimulation|a clicking sound was presented and the same electrodes montage set-up was used during rtACS and placebo stimulation, except that placebo patients received no current (stimulator turned off).
16214264|NCT01282814|Drug|Venlafaxine Hydrochloride|150 mg Extended-Release Capsule
16214265|NCT01282814|Drug|Effexor® XR|150 mg Extended-Release Capsule
16214266|NCT01282801|Drug|Venlafaxine Hydrochloride|150 mg Extended-Release Capsule
16214267|NCT01282801|Drug|Effexor® XR|150 mg Extended-Release Capsule
16214268|NCT01282788|Dietary Supplement|Caterpillar Cereal|Infants will receive once-daily servings of caterpillar cereal (30 g from 6-12 months of ages and 45 g from 12-18 months of ages). Study food will be delivered to homes weekly by Community Coordinators, who will also observe feedings of the cereal during the home visit. Feedings will be observed 3x/week for the first 3 weeks after enrollment, then 1x/week until 18 months of age. Parents and other care providers will receive specific instructions about cereal preparation and general education about feeding practices, food preparation and hygiene. This information will be reinforced during weekly visits.
16214269|NCT01282775|Behavioral|WEB + Environment|Participants receive weekly lessons via the Web along with additional tools for weight loss support
16214270|NCT01282775|Behavioral|WEB + Cash Incentive for Weight Loss|Participants are paid cash based on the percent weight lost at 3, 6, and 12 months.
16214271|NCT01282762|Biological|HEPLISAV|"0.5 mL administered intramuscularly (IM) at Week 0, Week 4 and Week 24.
~HEPLISAV booster injection = one dose of 0.5 mL volume when needed."
16214272|NCT01282762|Biological|Engerix-B|"2.0 mL administered intramuscularly (IM) at Week 0, Week 4, Week 8 and Week 24.
~Engerix-B booster injection = one dose of 2.0 mL volume when needed"
16214273|NCT01282749|Behavioral|SisterTalk Hartford|12-week group support and film-based healthy lifestyle education program, including information on healthy nutrition and food preparation, increasing activity and exercise, healthy lifestyle behavior modification, and supportive spiritual materials.
16214274|NCT01282749|Behavioral|Attention control video series|Participants received general film series on healthy lifestyles while waiting to participate in the experimental arm.
16214275|NCT01282736|Behavioral|Integrative Response Therapy|A 10 session manualized version of IRT is employed . Each of the 10 group therapy sessions will be 60 minutes in length. Non-specialty trained Masters-level therapists will lead IRT after undergoing IRT training with the PI.
16214276|NCT01282736|Behavioral|Cognitive Behavioral Therapy|A 10 session manualized version of CBT-GSH is employed . Each of the 10 group therapy sessions will be 60 minutes in length. Non-specialty trained Masters-level therapists will lead CBT-GSH after undergoing CBT-GSH training with the PI.
16214277|NCT01282697|Drug|Combined administration of irinotecan and rapamycin|This phase I trial is a dose escalation study of irinotecan + rapamycin with a 3+3 statistical design.
16214278|NCT01282684|Drug|PLX5622|PLX5622 drug substance is an achiral,small molecule Fms kinase inhibitor. The drug product is available in capsule form, to be taken orally, in dosage strengths of 25 mg and 100 mg with matching placebo
16214279|NCT01282684|Drug|Placebo|Matching placebo for PLX5622.
16214305|NCT01282437|Radiation|Prophylactic Cranial Irradiation|"18 fractions of 2Gy
~12 fractions of 2.5Gy
~10 fractions of 3 Gy"
16214306|NCT01282424|Drug|Idelalisib|Idelalisib 150 mg tablet administered orally twice daily
16214280|NCT01282671|Other|Breathing exercises|On the fourth postoperative day the patients are randomly assigned to a Treatment group continuing to perform deep breathing exercises for 2 months postoperatively and to a Control group who will perform no breathing exercises after the third postoperative day. Patient management is otherwise similar in the groups. The patients in the Deep breathing group will be instructed to perform breathing exercises (3 x 10 deep breaths) 5 times a day (document compliance) during the two postoperative months. A Positive expiratory pressure (PEP) device PEP ventil, System 22 (Rium Medical, Täby, Sweden) is used to create an expiratory resistance of +10 cm H2O.
16214281|NCT01282645|Device|PSI in PEEK|A Patient Specific Implant made of Polyether Ether Ketone to repair a cranial defect
16214282|NCT01282632|Drug|Risperidone|Risperidone will commence at 0.5 mg per day in a single daily dose given once in the evening. Clinicians will have the option, at each visit of increasing the risperidone dose to a maximum of 3 mg/day based on subject response and tolerability (please see Titration Recommendations below).
16214283|NCT01282632|Drug|Olanzapine|Olanzapine will commence at 2.5 mg per day in a single daily dose given once in the evening. Clinicians will have the option, at each visit, of increasing the olanzapine dose to a maximum of 15 mg/day based on subject response and tolerability.
16214284|NCT01282619|Drug|Huperzine A|Sustained-Release Tablet, 400µg once a day, 24 weeks
16214285|NCT01282619|Drug|huperzine A|Tablet, 200µg twice a day, 24 weeks
16214286|NCT01282619|Drug|Placebo|placebo orally twice a day
16214287|NCT01282606|Drug|SI-6603|SI-6603 is administrated into the nucleus pulposus of an intervertebral disc.
16214288|NCT01282593|Other|Impact of CD9 expression level on motility assays|"1) Assess of the impact of CD9 expression level on motility assays (migration and adhesion) We have initiated motility assays (fibronectin adhesion experiments and CXCL12 chemoattracted migration tests with modified Boyden chamber technique) using the CD9 positive TEL/AML1-positive cell line REH and the CD9 negative cell line RAJI (wild or transfected with CD9 cDNA). Data will be analyzed in combination with blocking antibodies and chemical antagonist according to the level of CD9 (transcript and protein) and of CXCR4. Protein quantifications will be performed by flow cytometry and Western Blot. Interactions will be explored by confocal microscopy and biological pathways by immunoblot.
~Adhesion results will be validated on patient samples of B-ALL."
16214289|NCT01282593|Other|Post-transcriptional regulation of CD9|"2) Post-transcriptional regulation of CD9 in TEL/AML1-positive ALL To identify miRNAs that are potentially deregulated in TEL/AML1-positive acute lymphoblastic leukaemia and especially to screen for CD9 -targeted miRNAs, we will use a TaqMan ®MicroRNA Arrays approach allowing the simultaneous measurement of about 760 human miRNA.
~Small RNA will be extracted from bone marrow samples of twenty childhood B-ALL to screen miRNAs which are differentially expressed between CD9-positive and CD9-negative ALL and further compared with miRNAs which were predicted to target CD9 in databases. Validation of the selection will be performed by single Q-PCR for selected miRNAs using a novel cohort of ten bone marrow samples."
16214290|NCT01282580|Dietary Supplement|Lovaza-Omega 3 fatty acid capsules|The study will require monthly visits at 0, 1, 2 and 3 months of study intervention. At each visit a fasting serum sample will be obtained, self-report diaries (adverse events, record of omega 3 supplement doses or fish servings taken/missed) will be collected, and pill count / labels from cans of fish will be recorded. Medications and supplements will be reviewed with participants at each monthly visit. At clinic visits at 0 and 3 months, a history and physical examination and breast adipose fine needle aspiration (FNA)will be performed.Omega 3 supplements will be dispensed in monthly amounts.
16214291|NCT01282580|Other|Dietary fish (canned salmon, albacore)|Participants randomized to dietary fish will be asked to incorporate fish in the form of canned albacore and salmon into their diets at four 6 oz servings per week for 3 months. Participants on the dietary fish arm of the study will receive recipes using canned salmon and/or albacore. Sufficient canned salmon/albacore will be available for subjects who wish to prepare a meal for the family/household. Dietary intake will be assessed via 3 day diet records (0 and 3 months) and food frequency questionnaires (0 and 3 months). Verbal and written instructions on how to keep diet records, with food measured or weighed, will be given.
16214292|NCT01282567|Other|Blood samples|The study will be proposed to four patients hospitalized in the Diabetes Unit for a glucidic fast test carried out during 24 hours (lunch, dinner and breakfast). Blood samples will be taken every 20 minutes during 6 hours and 40 minutes to measure plasma insulin concentration and blood glucose. T0 will correspond to the first modification of the insulin basal flow (in more or less) or to the first insulin bolus corrector, usually administered if capillary blood glucose reaches 1.8 g/l. The capillary blood glucose monitoring will be performed every two hours by the nurse.
16214293|NCT01282554|Device|electrostimulation program (Rehab 400)|"electrostimulation program (Rehab 400) : electrostimulation program during dialysis sessions for 3 months.
~Electrostimulation modalities have been chosen to seek both slow and fast muscle fibers : 35 Hz ; impulsion time: 400 µsec ; on/ off : 7'' contraction / 8'' relaxation. Stimulated muscles are quadriceps. Electrostimulation time will be 30 minutes. Each patient will individually regulate work intensity, maximal intensity should be the maximal tolerable intensity.
~Electrostimulation will be done 3 times per week. In case of asthenia or medical condition, electrostimulation can be delayed. The program will take place for 3 months."
16214294|NCT01282541|Drug|Botulinum Toxin Type A|100 units/2ml 0.9% sodium chloride, 5 units delivered transconjunctivally into the palpebral lobe of the lacrimal gland once
16214295|NCT01282541|Drug|Botulinum Toxin Type A|100 units/2ml 0.9% sodium chloride, 5 units delivered transcutaneously into the orbital lobe of the lacrimal gland once
16214296|NCT01282528|Biological|infliximab|3mg/kg, at week 0, 2, 6, 14, 22
16214297|NCT01282515|Drug|clobetasol propionate 0,05% ointment|continuously daily treatment for 6 weeks
16214298|NCT01282515|Drug|hexaminolevulinate|one PDT treatment
16214299|NCT01282502|Drug|Midostaurin|50 mg BID for 8 cycles
16214300|NCT01282476|Drug|Panobinostat with Rituximab|Panobinostat 40 mg orally 3 x weekly Rituximab 375 mg/m^2 IV days 1,8,15,and 22 of cycle 1, and then on day 1 of subsequent cycles.
16214301|NCT01282463|Drug|Docetaxel|Docetaxel: 75 milligram/square meter (mg/m2) on Day 1 of each 21-day cycle
16214302|NCT01282463|Biological|Ramucirumab DP|Ramucirumab (DP): 10 milligram/kilogram (mg/kg) intravenous (IV) on day 1 of each 21-day cycle
16214303|NCT01282463|Biological|Icrucumab|12 mg/kg I.V. on day 1 and Day 8 of each 21-day cycle
16214304|NCT01282450|Radiation|Radiotherapy|Radiotherapy
16216811|NCT01263145|Other|Pharmacological Study|Correlative studies
16214308|NCT01282398|Drug|placebo|the control group wiil take placebo pills for at least two years.
16214309|NCT01282385|Drug|Simvastatin|simvastatin 20 mg capsules, starting at doses of 20 mg / 24 hours, may increase to 40 mg according to clinical and laboratory tolerance
16214310|NCT01282385|Drug|placebo|placebo capsules with external characteristics similar to simvastatin administrated each 24 hours.
16214311|NCT01282359|Other|Clinical practice group|Clinical practice group will not receive any specific education
16214312|NCT01282359|Other|"Gold Standard educational group"|"Gold Standard educational group will receive a formal program of structured and individualized education"
16214313|NCT01282359|Other|Intervention group|Intervention group will take the limited educational asthma program which have three parts: basic information, establishment and revision of a small Action Plan (MiniPlan) and training and review of the inhalation skill of the prescribed device. Educators involved will attend a short workshop (6 h), where they will be trained in the program.
16214314|NCT01282346|Device|SOLX Gold Shunt|Single use implant
16214315|NCT01282333|Drug|gemcitabine hydrochloride|Given IV
16214316|NCT01282333|Drug|veliparib|Given orally
16214317|NCT01282333|Other|diagnostic laboratory biomarker analysis|Correlative studies
16214318|NCT01282333|Other|pharmacological study|Correlative studies
16214319|NCT01282333|Drug|cisplatin|Given IV
16214320|NCT01282320|Behavioral|Physical activity intervention program|Individually tailored exercise programme (combination of pilates and aerobe training) with one hour activity sessions two-three times per week in 16 weeks.
16214321|NCT01282307|Behavioral|Guided Self-Determination GSD|The method GSD consists of 21 worksheets designed to guide patient and mental health professionals through autonomy-supportive problem solving. The worksheets are filled in by the patient before and between conversations with their community nurse over 10 sessions, approximately 1 hour a session.
16214322|NCT01282294|Device|ETN PROtect|Expert Tibial Nail PROtect with Gentamicin coating
16214323|NCT01282268|Drug|arbaclofen|orally disintegrating tablet
16214324|NCT01282268|Drug|placebo|orally disintegrating tablet
16214325|NCT01282255|Drug|NNC109-0012|The subjects will receive 12 weekly doses of 3 mg/kg of NNC109-0012 administered subcutaneously (under the skin)
16214326|NCT01282255|Drug|placebo|The subjects will receive 12 weekly doses of 3 mg/kg of Placebo administered subcutaneously (under the skin)
16214327|NCT01282242|Drug|IV rt-PA|open-label
16214328|NCT01282229|Device|LANAP|Laser Assisted New Attachment Procedure (LANAP protocol) using the FR Pulsed Nd:YAG laser
16214329|NCT01282216|Biological|Havrix|1440 ELISA units, or 1 mL, IM
16214330|NCT01282216|Biological|PCV13|0.5 mL IM
16214331|NCT01282190|Behavioral|Motivational interview|Motivational interview
16214332|NCT01282164|Procedure|Glucagon stimulation test and insulin tolerance test|glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test in subjects with type 2 diabetes mellitus (T2DM), coronary artery disease (CAD), cerebrovascular disease (CVD), seizure
16214333|NCT01282164|Procedure|glucagon stimulation test and insulin tolerance test|glucagon stimulation test using 1 mg (1.5 mg if weigh >90 kg) glucagon stimulation test using 0.03 mg/kg (maximum dose 3 mg) insulin tolerance test using 0.10-0.15 U/kg ACTH stimulation test in subjects with type 2 diabetes mellitus (T2DM), coronary artery disease (CAD), CVD (cerebrovascular disease), seizure
16214334|NCT01282151|Drug|Taxotere|Docetaxel 60 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks
16214335|NCT01282151|Drug|Pemetrexed|Pemetrexed 500 mg/m2 q3 weeks Cisplatin 70 mg/m2 q3 weeks
16214336|NCT01282138|Drug|Olopatadine hydrochloride, 0.1% ophthalmic solution (Patanol)|One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.
16214337|NCT01282138|Other|Dextran 70 0.1%, hydroxypropyl methylcellulose 0.3% (Tears Naturale II)|One drop twice daily in each eye for 5 days, followed by an additional drop in each eye prior to allergen test.
16214338|NCT01282073|Drug|Mycophenolate mofetil, low dose steroid|"Mycophenolate Mofetil: Myconol capsule 250mg, Myconol 500 mg bid per day (less than 50kg), 750 ~ 1000 mg bid per day (more than 50kg)
~Steroid: Methylprednisone 4mg tablet or Prednisolone 5mg tablet or Deflazacort 6mg tablet. Prednisolone dose: 0.15mg/kg up to a maximum dose of 15mg/day
~Duration: 48 weeks"
16214339|NCT01282073|Drug|Cyclosporin, low dose steroid|"Cyclosporin: Implanta soft cap (cyclosporin microemulsion) 25mg/100mg, starting dose of 4mg/kg per day and titrate according to investigator's decision based on cyclosporin trough level (100±50 ng/ml)
~Steroid: same dosage with active comparator goup
~Duration: 48 weeks"
16214340|NCT01282047|Drug|Lenalidomide|oral course, 25 mg, day 1 to 21, per month, 7 days of wash-out each month. Duration according to initial response: 24 weeks and 12 weeks more if complete remission, 24 weeks more if partial remission or stable disease and stop in case of progression.
16214341|NCT01282034|Procedure|Marrow stimulation - Drilling or Microfractures|"Subchondral drilling consists in penetration of the subchondral bone endplate and creation of holes, and it is mostly indicated for the treatment of osteochodral lesion.
~Microfractures (MF), according to Steadman's technique, are one of the most used first-line treatment for cartilage injuries, and commonly considered safe and effective."
16214342|NCT01282034|Device|MaioRegen Surgery|MaioRegen® (is a bioceramic, multi-layered scaffold, in a single gradient structure, consisting of deantigenated Type I equine collagen and Magnesium enriched-Hydroxyapatite, able to mime the entire osteocartilaginous section. MaioRegen® is able to promote the tissue regeneration in case of severe and large chondral/osteochondral lesions.
16214343|NCT01281969|Drug|Gamunex Intravenous Immunoglobulin|2.0 gm/kg total, IV (in the vein), over 2 days
16214344|NCT01281969|Drug|Placebo|Normal saline, IV (in the vein), over 2 days
16214345|NCT01281956|Drug|PRX-00023|PRX-00023 (Selective 5HT1A agonist)
16214346|NCT01281956|Drug|Placebo|Placebo
16214347|NCT01281943|Drug|Temsirolimus 25mg and Pegylated liposomal doxorubicin 25mg/m2|"Temsirolimus 25mg IV on days 1, 8, 15 and 22 of each 28 day cycle
~Pegylated liposomal doxorubicin 25mg/m2 IV on day 1 of each 28 day cycle"
16214348|NCT01281930|Procedure|Full packing into abscess cavity|After incision and drainage plain 1/4-1/2 inch gauze packing material is placed into the cavity to fill it
16214569|NCT01280409|Drug|Metformin|Subjects will receive metformin 850 mg PO daily for 7 days, then metformin 850mg PO twice a day for the next 5 weeks
16214349|NCT01281930|Procedure|Wick placement into abscess cavity|After incision and drainage of the abscess a piece of plain gauze 1/4-1 inch packing material that is as wide as can be easily passed through the opening is placed into the cavity spanning one diameter of the cavity
16214350|NCT01281917|Drug|Velcade|Velcade, 1.6 mg/m2 weekly (days 1, 8, 15, and 22)
16214351|NCT01281917|Drug|Temsirolimus|Temsirolimus 25mg IV weekly (days 1, 8, 15, 22, and 29)
16214352|NCT01281904|Behavioral|Relaxation Acupressure|Apply pressure on 9 relaxatory acupressure points for 3 minutes each once daily for a 6 week period, followed by a 4 week wash-out period.
16214353|NCT01281904|Behavioral|Stimulating Acupressure|Apply pressure on 10 excitatory acupressure points for 3 minutes each once daily for a 6 week period, followed by a 4 week wash-out period.
16214354|NCT01281891|Drug|LIA|Ropivacaine 0.2% Ketorolac 30 mg Adrenaline 0.1 mg/ml
16214355|NCT01281891|Drug|I/T morphine|Morphine special 0.1 mg injected intrathecally
16214356|NCT01281878|Drug|Vitamin B 6|Oral solution of pyridoxal phosphate start with 5mg per kg body weight per day in two dosages over 6 weeks, increase stepwise by 5mg/kg body weight every 6 weeks up to 20 mg/kg body weight/d.
16214357|NCT01281865|Other|diagnostic laboratory biomarker analysis|Correlative studies
16214358|NCT01281865|Drug|everolimus|Given PO
16214359|NCT01281865|Drug|imatinib mesylate|Given PO
16214360|NCT01281852|Drug|Cisplatin|Given IV
16214361|NCT01281852|Other|Laboratory Biomarker Analysis|Correlative studies
16214362|NCT01281852|Drug|Paclitaxel|Given IV
16214363|NCT01281852|Drug|Veliparib|Given PO
16214364|NCT01281839|Drug|TMC435|150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a and ribavirin for 24 or 48 weeks
16214365|NCT01281839|Drug|Placebo|150 mg capsule once daily for 12 weeks in addition to peginterferon alfa-2a and ribavirin for 48 weeks
16214366|NCT01281839|Drug|Peginterferon alpha-2a (PegIFN alpha-2a)|One subcutaneous (under the skin) injection containing 0.5 mL solution with 180 mcg PegIFN alpha-2a once weekly for up to 48 weeks.
16214367|NCT01281839|Drug|Ribavirin (RBV)|200-mg tablets of RBV (body-weight adjusted dose) taken orally (by mouth) twice daily for up to 48 weeks.
16214368|NCT01281813|Drug|Darunavir|600 mg tablet, intake of 1 tablet twice a day in combination with ritonavir
16214369|NCT01281813|Drug|Ritonavir|100 mg capsule, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
16214370|NCT01281813|Drug|Darunavir|400 mg tablet, intake of 2 tablets once daily in combination with ritonavir
16214371|NCT01281813|Drug|Ritonavir|100 mg tablet, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
16214372|NCT01281813|Drug|Darunavir|375 mg tablet (made up of 2 x 150mg +1 x 75mg tablets), intake of 3 tablets twice a day in combination with Ritonavir
16214373|NCT01281813|Drug|Darunavir|Darunavir oral suspension (dose dependent on weight) in combination with Ritonavir
16214374|NCT01281813|Drug|Ritonavir|Ritonavir oral solution as 80 mg/mL (dose dependent on weight) in combination with Darunavir twice daily
16214375|NCT01281813|Drug|Ritonavir|Ritonavir powder for oral suspension prepared as 100 mg/10 mL (dose dependent on weight) in combination with Darunavir
16214376|NCT01281800|Procedure|Gemcitabine in long infusion|"TREATMENT A:
~Day 1: Pemetrexed 500 mg/m2 Cisplatin 75 mg/m2 Cycle every 3 weeks. Supportive treatment: folic acid [Tifol 400 mg tbl (350-1000 mg), beginning 7 days before CT, every day, till 3 week after the KT], vitamin B-12 [OH-B12 i.m., beginning in 7 days before CT, than at 3. + 6. cycles of KT + 9. week after the KT], corticosteroids, hydration, antiemetic, LMW heparin as thromboprophylaxis.
~In the absence of progression, 4 cycles of chemotherapy with pemetrexed and cisplatin will be given, followed by two additional cycles of pemetrexed as monotherapy.
~TREATMENT B:
~Days 1 and 8: gemcitabine 250 mg/m2 in 6 hours day 2: cisplatin 75 mg/m2 Cycle every 3 weeks. Supportive treatment: corticosteroids, hydration, antiemetics, LMW heparin as thromboprophylaxis.
~In the absence of progression, 4 cycles of chemotherapy with gemcitabine and cisplatin will be given, followed by two additional cycles of gemcitabine alone as monotherapy."
16214377|NCT01281787|Drug|Metoprolol|Metoprolol; 100 mg x 2 die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay
16214378|NCT01281787|Drug|Losartan|Losartan; 50 mg die (tablets); started within 12 hours after surgery and continued for the duration of hospital stay
16214379|NCT01281774|Biological|CSL112|reconstituted high density lipoprotein
16214380|NCT01281774|Biological|Placebo|Normal saline (0.9%)
16214381|NCT01281761|Drug|cetuximab/irinotecan/simvastatin|D1 Cetuximab 500mg/m2 IV stepwise shortened infusion duration- [C1D1 over 120min, C2D1 over 90min,subsequent dose over 60min] D1 Irinotecan 150-180mg/m2 + Dextrose 5% 500ml IV [over 90min] D1-14 Simvastatin 80mg P.O(continuous, daily) every 2weeks
16214382|NCT01281748|Drug|intravenous methylprednisolone|methylprednisolone 0,5 mg/kg every 6 hours for 72 hours, 0,5 mg/kg every 12 hours on days 4 through 6, 0,5 mg/kg daily for day 7 through day 10
16214383|NCT01281748|Other|intravenous normal saline solution|50 ml of intravenous normal saline solution every 6 hours for 72 hours, 50 ml every 12 hours on days through 6, 50 ml daily for day 7 through day 10.
16214384|NCT01281696|Drug|Bevacizumab, etoposide, cisplatin|Bevacizumab (15mg/kg) on D1, etoposide (70mg/m2) on D2-D4, cisplatin (70mg/m2) on D2; 21 days a cycle, for a maximum of 6 cycles
16214385|NCT01281696|Drug|Intrathecal methotrexate|Additional intrathecal methotrexate only given in patients with leptomeningeal metastasis
16214386|NCT01281670|Other|vibration|8 week vibration
16214387|NCT01281657|Drug|fingolimod|
16214388|NCT01281644|Device|Diode Laser|810 nm diode laser
16214389|NCT01281631|Drug|NP001|Low dose of NP001
16214390|NCT01281631|Drug|NP001|High dose of NP001
16214391|NCT01281631|Drug|Placebo|normal saline
16214392|NCT01281618|Procedure|24 hour pH study and upper endoscopy (EGD)|All subjects enrolled will undergo 24 hour pH followed by EGD.
16214393|NCT01281605|Behavioral|Active titration algorithm|Patients in active titration algorithm group will contact with investigator by telephone weekly to self-adjust the insulin dose till they achieve the target of FPG(<110mg/dl).
16214487|NCT01280942|Device|Wireless Remote Sensor|A subset of patients will be consented to wear a wireless sensor device which will monitor heart rate and level of oxygen in the blood.
16214488|NCT01280929|Procedure|Panretinal Photocoagulation (PRP)|
16214394|NCT01281605|Behavioral|Usual titration algorithm|All patients will be instructed to self-measure fasting capillary blood glucose. The dose of insulin detemir will be adjusted based on the average of three consecutive FPG values. the daily insulin dose should be increased by 2 IU/day if the FPG>=110mg/dL, and by 4 IU/day if the FPG>=180 mg/dL without any intervening hypoglycemic episodes; or it should be decreased by 2 or 4 IU/day if the FPG < 70 mg/dL.
16214395|NCT01281592|Drug|LOR-253 HCl|LOR-253 HCl will be given in ascending doses starting from 20 mg/m2 until the maximum administered dose or appropriate target dose is reached. Patient will be treated on LOR-253 HCl for 2 cycles for the evaluation.
16214396|NCT01281579|Drug|Canagliflozin 100 mg|Tablets, oral, 100-mg, once daily on Day 1 and on Days 4 through 9.
16214397|NCT01281579|Drug|Canagliflozin 50 mg|Tablets, oral, 50-mg, once daily on Day 1 and on Days 4 through 9.
16214398|NCT01281579|Drug|Canagliflozin 300 mg|Tablets, oral, 300-mg, once daily on Day 1 and on Days 4 through 9.
16214399|NCT01281566|Drug|Placebo|liquid suspension identical in appearance to Cisapride 4 times a day (q.i.d.) for up to 42 days
16214400|NCT01281566|Drug|Cisapride|0.2 mg/kg liquid suspension 4 times a day (q.i.d.) for up to 42 days
16214401|NCT01281553|Drug|Placebo|Suspension identical in appearance to cisapride q.i.d. for 8 weeks.
16214402|NCT01281553|Drug|Cisapride|0.2 mg/kg suspension q.i.d.for 8 weeks.
16214403|NCT01281540|Drug|Cisapride|one 10 mg tablet 4 times a day for 8 weeks
16214404|NCT01281540|Drug|Placebo|one placebo tablet 4 times a day for 8 weeks
16214405|NCT01281527|Drug|Paliperidone Palmitate|50 - 150 mg eq. every 30 days
16214406|NCT01281514|Drug|everolimus|Given PO
16214407|NCT01281514|Drug|carboplatin|Given IV
16214408|NCT01281514|Drug|pegylated liposomal doxorubicin hydrochloride|Given IV
16214409|NCT01281514|Other|laboratory biomarker analysis|Correlative studies
16214410|NCT01281501|Drug|Normal saline|10 ml of 0.9% sodium chloride solution
16214411|NCT01281501|Drug|Pantoprazole|80 mg of intravenous pantoprazole
16214412|NCT01281501|Drug|Oral antacid|30 ml of oral antacid (1.32 grams of aluminum hydroxide, 0.72 grams of magnesium hydroxide)
16214413|NCT01281501|Drug|Hyoscine butylbromide|20 mg of intravenous hyoscine butylbromide
16214414|NCT01281488|Procedure|fluorescence imaging|Undergo NIR fluorescence imaging with ICG on the da Vinci surgical system
16214415|NCT01281488|Procedure|laparoscopic surgery|Undergo standard approach robot-assisted laparoscopic partial nephrectomy
16214416|NCT01281488|Drug|indocyanine green|Given IV
16214417|NCT01281475|Drug|Levodopa|"Levodopa/Carbidopa (4:1)
~Dosages are based on levodopa.
~Subjects randomized to the levodopa arm will receive a levodopa dose of 5 mg/kg/day in the first 2 weeks of the study, a levodopa dose of 10 mg/kg/day in the second 2 weeks of the study, and a levodopa dose of 15 mg/kg/day (up to a maximum of 800 mg per day) for the remaining duration of the study.
~Levodopa/Carbidopa is a combined formulation that will be dispensed as capsules. It should be taken 3 times a day."
16214418|NCT01281475|Drug|Placebo Oral Capsule|The placebo contains excipients similar to those in the active drug, but it does not contain levodopa or carbidopa.
16214419|NCT01281462|Drug|Ceftaroline fosamil and NXL104 (q8h)|600 mg ceftaroline fosamil/600 mg NXL104 IV coadministered every 8 hours (q8h);
16214420|NCT01281462|Drug|Ceftaroline fosamil and NXL104 (q12h)|600 mg ceftaroline fosamil/600 mg NXL104 IV coadministered every 12 hours (q12h);
16214421|NCT01281462|Drug|Doripenem|500 mg doripenem IV q8h;
16214422|NCT01281462|Drug|Placebo|On CXL-MD-02, there were (3) treatment arms (meaning a subject could be randomized to 1 of 3 possible treatment regimens). Each treatment arm contained 1 or 2 placebo doses of IV saline in order to preserve the blind.
16214423|NCT01281436|Other|HeartSmartKids & Web-based Provider Training|The providers assigned to Group 2 will receive the web-based training described in the web-based training arm, plus the HeartSmartKids™ (HSK) system. HSK is a bilingual, HIT kiosk system with clinical decision support and tailored patient education.
16214424|NCT01281436|Other|Web-based Provider Training|The training will include information about implementing the recommendations of the AMA, the pediatric metabolic working group, and the HEATSM guidelines into their practice setting through the use of the chronic care model for childhood obesity. Training will include self-management support, decision support, delivery-system redesign, clinical information systems, practice self-assessment, and staff development on obtaining, assessing, documenting BMI and BP; counseling families on appropriate interventions; and quality improvement processes to evaluate the practice's performance strategies.
16214425|NCT01281410|Procedure|Inspiratory Muscle Training|Inspiratory Muscle Training with Respifit (5 times per week)
16214426|NCT01281410|Other|inspiratory muscle training|Inspiratory muscle training with a device named Respifit for patients receiving a hematopoetic stem cell transplantation (till 30 days after their transplantation)
16214427|NCT01281384|Other|Advanced Imaging|
16214428|NCT01281384|Other|Standard Imaging|
16214429|NCT01281358|Other|HOP-ON|A programme of activities which promote motor development
16214430|NCT01281358|Other|SMILES|Details are provided on ways for parents to interact with their premature infants
16214431|NCT01281332|Device|Menopod|The mechanism of action of the device will not be revealed in advance.
16214432|NCT01281332|Device|Inactive device|
16214433|NCT01281306|Drug|LCZ696|LCZ696 was supplied as tablets in blister cards in 100 mg strengths.
16214434|NCT01281306|Drug|Valsartan|Valsartan was supplied as tablets in blister cards in 160 mg and 320 mg strengths.
16214435|NCT01281306|Drug|AHU377|AHU377 was supplied in tablets in blister cards in 50 mg and 100 mg strengths.
16214436|NCT01281306|Drug|Placebo|Placebo was supplied as tablets in blister cards.
16214437|NCT01281267|Procedure|Facial Allograft Transplantation|Facial allograft transplantation surgery is the transfer of face tissue from a deceased human donor to a patient with a severe facial deformity.
16214489|NCT01280929|Drug|Intravitreous injection of ranibizumab|
16214490|NCT01280916|Behavioral|Mindful Awareness in Body-oriented Therapy|8 weekly sessions of 1.5 hours each delivered to women in substance use disorder treatment
16214515|NCT01280721|Drug|tolvaptan|Repeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg.
16214644|NCT01279681|Biological|bevacizumab|Given IV
16214645|NCT01279681|Drug|capecitabine|Given PO
16214438|NCT01281254|Drug|AMG386 plus PLD|AMG 386 is a first in class investigational anti angiogenic drug that provides potent and selective inhibition of angiopoietins. AMG 386 is designed to inhibit angiogenesis by sequestering Ang1 and Ang2, thereby preventing their interaction with the Tie2 receptor. Pegylated Liposomal Doxorubicin (Doxil/Caelyx) is a preparation of doxorubicin in a liposome that contains surface-grafted segments of the hydrophilic polymer methoxypolyethylene glycol associated with prolonged pharmacokinetics of the free drug. PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 15 mg/kg IV weekly (QW)
16214439|NCT01281254|Drug|Placebo plus PLD|"Pegylated Liposomal Doxorubicin (Doxil/Caelyx) is a preparation of doxorubicin in a liposome that contains surface-grafted segments of the hydrophilic polymer methoxypolyethylene glycol associated with prolonged pharmacokinetics of the free drug.
~PLD 50 mg/m2 IV every 4 weeks (Q4W) and blinded AMG 386 placebo IV weekly (QW)"
16214440|NCT01281228|Drug|exenatide|The loading dose is 50 ng/min during 30 min, followed by a maintenance dose 20 ng/min for the rest of the tests.
16214441|NCT01281228|Drug|exenatide + exendin (9-39)|The loading dose is 50 ng/min during 30 min, followed by a maintenance dose 20 ng/min for the rest of the tests. Exendin 9-39 will be infused intravenously at doses of 600 pM/kg • min.
16214442|NCT01281228|Drug|placebo|saline infusion
16214443|NCT01281215|Behavioral|Education interventional|The patients will receive pharmaceutical education to know more about asthma, the importance of treatment compliance, the medications used to control the pathology, corrected patients' inhalation techniques and the medication care.
16214444|NCT01281202|Drug|Vigabatrin|Tablets
16214445|NCT01281202|Drug|Matching Placebo|Tablets
16214446|NCT01281189|Drug|Dexpramipexole|Oral tablet 150mg twice daily for up to 18 months.
16214447|NCT01281189|Drug|Placebo|Oral tablet twice daily for up to 18 months.
16214448|NCT01281176|Drug|Carboplatin|Given IV
16214449|NCT01281176|Other|Laboratory Biomarker Analysis|Correlative studies
16214450|NCT01281176|Drug|Paclitaxel|Given IV
16214451|NCT01281176|Other|Pharmacological Study|Correlative studies
16214452|NCT01281176|Drug|Vorinostat|Given PO
16214453|NCT01281163|Drug|Akt Inhibitor MK2206|Given PO
16214454|NCT01281163|Other|Laboratory Biomarker Analysis|Correlative studies
16214455|NCT01281163|Drug|Lapatinib Ditosylate|Given PO
16214456|NCT01281163|Other|Pharmacogenomic Study|Correlative studies
16214457|NCT01281163|Other|Pharmacological Study|Correlative studies
16214458|NCT01281150|Drug|Carboplatin|Given IV
16214459|NCT01281150|Other|Laboratory Biomarker Analysis|Correlative studies
16214460|NCT01281150|Drug|Paclitaxel|Given IV
16214461|NCT01281150|Other|Pharmacological Study|Correlative studies
16214462|NCT01281150|Drug|Veliparib|Given PO
16214463|NCT01281137|Genetic|polymorphism analysis|SNPs will be genotyped in whole blood samples taken at baseline.
16214464|NCT01281137|Other|laboratory biomarker analysis|Biomarkers will be assessed in blood and serum samples at different time points.
16214465|NCT01281137|Procedure|quality-of-life assessment|Quality of life will be assessed using the Breast Cancer Prevention Trial (BCPT) Symptom Scales and the IBCSG Trial 35-07 QL Form.
16214466|NCT01281124|Drug|Azacitidine|Given subcutaneously
16214467|NCT01281124|Other|Diagnostic Laboratory Biomarker Analysis|Correlative studies
16214468|NCT01281124|Other|Pharmacological Study|Correlative studies
16214469|NCT01281111|Drug|Dimethyl Fumarate (BG00012)|
16214470|NCT01281111|Drug|Aspirin|
16214471|NCT01281111|Drug|BG00012 matching placebo|
16214472|NCT01281111|Drug|ASA matching placebo|
16214473|NCT01281098|Procedure|Panretinal Photocoagulation (PRP)|Panretinal Photocoagulation (PRP)
16214474|NCT01281098|Drug|Intravitreous injection of pegaptanib|Intravitreous injection of pegaptanib
16214475|NCT01281072|Other|vaccine|
16214476|NCT01281059|Device|BreathID - Breath Test - 13C Octanoate|
16214477|NCT01281033|Procedure|Manual Thrombectomy|In patients in the thrombus-aspiration group, this step is followed by the advancing of the 6-French Export Aspiration Catheter (Medtronic; crossing profile, 0.068 in.) into the target coronary segment during continuous aspiration.
16214478|NCT01281033|Procedure|AngioJet Rheolytic Thrombectomy (RT) System|The AngioJet Rheolytic Thrombectomy (RT) System consists of a drive unit console, disposable pump set, and disposable catheter. Thrombectomy is accomplished by the introduction of a pressurized high velocity saline stream through directed orifices in the catheter distal tip so that thrombus is entrained (Bernoulli effect), dissociated into small particles, and evacuated from the body through the catheter and associated tubing. The pump set consists of a high pressure pulsatile pump which is used to generate the flow necessary for the dissociation and evacuation of thrombus, an effluent bag for the collection and storage of thrombus debris, and associated tubing.
16214479|NCT01281007|Drug|Famciclovir|Famciclovir 125 mg every 12 hours for 5 days
16214480|NCT01281007|Drug|Aciclovir|Aciclovir 200 mg every 4 hours fo 5 days
16214481|NCT01280994|Drug|Hyperpolarized 129Xenon Gas|Hyperpolarized 129Xenon Gas will be administered in multiple doses in volumes that are tailored to the subject's total lung capacity (TLC) followed by a breath hold of up to 15 seconds. Subsequent 129Xe doses will only be administered once the subject is ready to proceed.
16214482|NCT01280981|Drug|Tranexamic acid|Tranexamic acid at an oral dose of 1.3 g administered 3 times per day for up to 5 days (maximum of 15 doses) during menstruation for 9 menstrual periods.
16214483|NCT01280968|Biological|NIC002 in Aluminum hydroxide (Alum)|Fifty-five subjects will receive 4 subcutaneous injections of 0.1 mg Nicotine-QB (NIC002) in Alum vaccine with a 4-week interval between injections.
16214484|NCT01280968|Biological|Placebo Vaccine - Aluminum hydroxide|Ten subjects will receive 4 subcutaneous injections of indistinguishable placebo (Alum alone) with a 4-week interval between injections.
16214485|NCT01280955|Drug|Plerixafor|Matched sibling or Dual Cord donor subjects will receive plerixafor at 240 ug/kg subcutaneously every other day beginning at day +2 after transplant until day +21 or engraftment occurs.
16214486|NCT01280942|Behavioral|EWS Nursing Alerts|An automated algorithm (EWS) will identify patients at potential risk of clinical deterioration. When a patient satisfies the algorithm, a nurse on the patient's ward will be notified. S/he will assess the patient and institute any interventions that are clinically required.
16214568|NCT01280487|Drug|ZSTK474|Daily oral dosing for 21 days each cycle
16214491|NCT01280903|Behavioral|STAR Intervention|The 24-week modified Staying Active with Arthritis (STAR) intervention, guided by self-efficacy theory and modified to address comorbid hypertension, consists of 6 weekly individual face-to-face exercise sessions by a licensed physical therapist, 9 biweekly telephone counseling sessions by a registered nurse to continue the use of self-efficacy strategies, and lower extremity exercise and fitness walking being carried out at home between sessions. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.
16214492|NCT01280903|Behavioral|Attention-Control|Attention-Control is a 24-week general health education program for older adults that consists of 6 weekly telephone sessions by a registered nurse followed by 9 biweekly telephone sessions by a registered nurse. There will be no contact with participants during weeks 7, 9, 11, 13, 15, 17, 19, 21, and 23. Topics include cancer screenings; immunizations; osteoporosis; low vision; hearing loss; talking with your primary care provider; eating healthy (two parts); sleep and aging; injury prevention (two parts: balance problems and falls); oral health; foot care; and mental health (depression). During the 6-month follow-up period, the participants will be contacted briefly by telephone by a registered nurse at weeks 30, 36, and 48 for a general check-up.
16214493|NCT01280890|Behavioral|Staff training using VIPS|Staff training using the VIPS framework
16214494|NCT01280890|Behavioral|Staff training using DCM|The staff will be supervised using Dementia Care Mapping
16214495|NCT01280890|Behavioral|Control group|Filmed traditional Lectures will be given to care staff
16214496|NCT01280877|Device|tACS|Transorbital alternating current stimulation (tACS) is applied with a multi-channel device with paraorbital montage of 4 stimulation electrodes generating weak current pulses in predetermined firing bursts of 8 to 14 pulses. The amplitude of each current pulse was below 1000 microA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation.
16214497|NCT01280877|Device|Sham stimulation|tACS is applied with the same device with equal electrodes set-up procedures but only one of four channels actually delivers current. The current intensity of this channel is individually adjusted (preselected on the side of lesioned eye) according with patient able to clearly perceive single phosphenes or any skin irritation phenomena (like weak sense of needles or vibration) whenever a single pulse is applied. The amplitude of pulses is always below 1000 microA. Current pulses are given as 1 pulse per minute during 25-35 min of session time. Session duration is equal for verum and sham patients. The perception of the single pulses leaves sham patients at the impression that they might receive the verum intervention, but total number of pulses is less than 0,5% of verum tACS.
16214498|NCT01280851|Procedure|Magnetic Resonance Imaging|1 hour of MRI exam will be performed in addition to the standard of care procedures, using low dose of gadolinium-based contrast (not investigational drug).
16214499|NCT01280838|Behavioral|Hombre Seguro|A theory-based intervention that uses principles of behavior change derived from Social Cognitive Theory (SCT), Cognitive Behavioral Therapy (CBT), Theory of Reasoned Action (TRA), and MI to increase clients' use of condoms with FSWs.
16214500|NCT01280838|Behavioral|Didactic attention-control condition|The didactic control condition is a modified version of the CDC's revised guidelines for HIV counseling, testing, and referral and materials from Mexico's National Center for AIDS Studies (CENSIDA). The one-session, 60-minute counseling intervention focuses on HIV and STI prevention, risk appraisal, and the development of a risk reduction plan.
16214501|NCT01280812|Behavioral|Mobile phone based physical activity intervention with maintenance plus|This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer and a mobile phone physical activity diary.
16214502|NCT01280812|Behavioral|Mobile phone based physical activity intervention with maintenance regular|This group will receive a mobile phone software program and a pedometer. Over a 3-month period, participants in this group will be asked to wear a pedometer, use a mobile phone physical activity diary, and respond daily physical activity messages or video clips. Over a 6-month maintenance period, participants will be asked to continue using a pedometer.
16214503|NCT01280812|Behavioral|Control (pedometer only)|This group will receive a pedometer. Over a 9-month period, participants in this group will be asked to wear a pedometer.
16214504|NCT01280799|Behavioral|Acceptance-based separated family treatment|Family treatment that combines Acceptance and Commitment Therapy (ACT) for the adolescent with Parent Skills Training for caregivers. The treatment package is designed to increase willingness to experience difficult thoughts, feelings, and bodily sensations in order to engage in effective behavior. To facilitate this, caregivers are provided with psychoeducation on eating disorders and skills in behavior management, self-regulation, and emotion regulation.
16214505|NCT01280786|Drug|Elesclomol Sodium|Weekly intravenous administration of escalating doses of elesclomol sodium provided response is seen after the first 4 week cycle.
16214506|NCT01280773|Device|NAVA|Neurally adjusted ventilatory assist (NAVA) was delivered by a SVi ventilator. NAVA utilizes EAdi, a reflection of the neural respiratory output to diaphragm, as its primary source to trigger and cycle-off assist in synchrony with neural inspiratory efforts.
16214507|NCT01280760|Other|Device: Neurally Adjusted Ventilatory Assistance|"Device: Neurally Adjusted Ventilatory Assistance
~In ICU following extubation NIV was performed as follows:
~facial mask with PSV/NIV mode to define settings for NAVA ventilation facial use with NAVA/NIV mode"
16214508|NCT01280747|Other|prior authorization|This is a naturalistic study. The physician will prescribe medication(s) as appropriate
16214509|NCT01280747|Other|no prior authorization|This is a naturalistic study. The physician will prescribe medication(s) as appropriate
16214510|NCT01280747|Other|prior authorization|This is a naturalistic study. The physician will prescribe medication(s) as appropriate
16214511|NCT01280747|Other|no prior authorization|This is a naturalistic study. The physician will prescribe medication(s) as appropriate
16214512|NCT01280734|Drug|Circadin (R) 2 mg|One 2 mg tablet at 23:00
16214513|NCT01280734|Drug|Stilnox (R) 10 mg|One 10 mg encapsulated tablet at 23:00
16214514|NCT01280734|Drug|Placebo|One tablet or encapsulated tablet at 23:00
16214646|NCT01279681|Drug|fluorouracil|Given IV
16214647|NCT01279681|Drug|leucovorin calcium|Given IV
16214516|NCT01280708|Other|Capture data|Capture and standardization of data of patients aged over 18 years received a kidney transplant or a simultaneous pancreas-kidney transplant from data sources will be performed by clinical research associates.The quality of data will be validated by cross annual audits. The statistical analysis will be made on a case by case according to clinical objectives.
16214517|NCT01280695|Drug|Placebo|Placebo Capsules
16214518|NCT01280695|Drug|MSDC-0602 100 mg|MSDC-0602 100 mg Capsules
16214519|NCT01280695|Drug|MSDC-0602 250 mg|MSDC-0602 250 mg Capsules
16214520|NCT01280695|Drug|MSDC-0602 250 mg|MSDC-0602 500 mg Capsules
16214521|NCT01280695|Drug|Pioglitazone|Pioglitazone 45 mg Capsules
16214522|NCT01280682|Drug|rituximab|anti-CD20 monoclonal antibody 125mg/m^2 day1 day8 day15 day22 repeat after six months (only day1 and day8)
16214523|NCT01280669|Drug|Intravitreal injection 440mcg|Intravitreal injections of sirolimus 440mcg/20mcL at baseline and months 1, 2, 3, 4, and 5.
16214524|NCT01280669|Drug|Intravitreal injection of sirolimus 880mcg|Intravitreal injection of 880mcg/20mcL sirolimus at baseline and months 2 and 4.
16214525|NCT01280656|Drug|Conventional Interferon|Conventional interferon according to the standard of care and aligned with the local prescription instructions
16214526|NCT01280656|Drug|Peginterferon Alfa-2a|Peginterferon alfa-2a according to the standard of care and aligned with the local prescription instructions
16214527|NCT01280656|Drug|Peginterferon Alfa-2b|Peginterferon alfa-2b according to the standard of care and aligned with the local prescription instructions
16214528|NCT01280656|Drug|Ribavirin|Ribavirin according to the standard of care and aligned with the local prescription instructions
16214529|NCT01280643|Drug|fluorouracil|Given IV
16214530|NCT01280643|Drug|leucovorin calcium|Given IV
16214531|NCT01280643|Drug|oxaliplatin|Given IV
16214532|NCT01280643|Drug|irinotecan hydrochloride|Given IV
16214533|NCT01280643|Biological|bevacizumab|Given IV
16214534|NCT01280643|Biological|cetuximab|Given IV
16214535|NCT01280643|Drug|capecitabine|Given PO
16214536|NCT01280643|Genetic|mutation analysis|Correlative studies
16214537|NCT01280643|Genetic|gene expression analysis|Correlative studies
16214538|NCT01280643|Other|laboratory biomarker analysis|Correlative studies
16214539|NCT01280643|Other|immunohistochemistry staining method|Correlative studies
16214540|NCT01280643|Genetic|nucleic acid sequencing|Correlative studies
16214541|NCT01280643|Genetic|protein expression analysis|Correlative studies
16214542|NCT01280643|Genetic|polymerase chain reaction|Correlative studies
16214543|NCT01280643|Genetic|DNA analysis|Correlative studies
16214544|NCT01280617|Drug|Thymoglobulin|Thymoglobulin 1.25mg/kg dose
16214545|NCT01280617|Drug|Thymoglobulin 0.75mg/kg dose|Thymoglobulin
16214546|NCT01280604|Drug|Fenofibrate 54mg|Subjects will receive fenofibrate 54mg daily.
16214547|NCT01280591|Drug|Naproxen sodium 440 mg / DPH 50 mg (BAY98-7111)|Participants received two Naproxen sodium 220 mg / DPH (Diphenhydramine hydrochloride) 25 mg tablets orally, single dose
16214548|NCT01280591|Drug|Naproxen sodium 220 mg / DPH 50 mg (BAY98-7111)|Participants received one Naproxen sodium 220 mg / DPH 50 mg tablet and one matching placebo capsule orally, single dose
16214549|NCT01280591|Drug|Naproxen sodium 440 mg (BAYH6689)|Participants received two Naproxen sodium 220 mg tablets orally, single dose
16214550|NCT01280591|Drug|DPH 50 mg|Participants received two DPH (Diphenhydramine hydrochloride) 25mg tablets orally, single dose
16214551|NCT01280578|Device|Transcatheter PFO Closure|Transcatheter PFO Closure
16214552|NCT01280565|Drug|Masitinib|Masitinib 7.5 mg/kg/day
16214553|NCT01280565|Drug|Dacarbazine|IV bolus at 1,000 mg/m2 once every 3 weeks
16214554|NCT01280552|Biological|ICT-107|Autologous dendritic cells pulsed with immunogenic antigens
16214555|NCT01280552|Biological|Placebo DC|Autologous dendritic cells (DC) that have not been pulsed with antigens
16214556|NCT01280539|Device|Transcutaneous electrical nerve stimulation|3 weeks, 5 times a week, 60 minutes a day.
16214557|NCT01280526|Drug|Romidepsin and CHOP|Romidepsin dose administered IV at day 1 and 8 or at day 1 without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered every 3 weeks for 8 cycles in patients with T-cell lymphoma
16214558|NCT01280526|Drug|Romidepsin and CHOP|Romidepsin dose administered IV at day 1 and 8 or at day 1 without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered every 3 weeks for 8 cycles in patients with T-cell lymphoma
16214559|NCT01280526|Drug|Romidepsin and CHOP|Romidepsin dose administered IV at day 1 and 8 or at day 1 without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered every 3 weeks for 8 cycles in patients with T-cell lymphoma
16214560|NCT01280526|Drug|Romidepsin and CHOP|Romidepsin dose administered IV at day 1 and 8 or at day 1 without day 8 in combination with cyclophosphamide, doxorubicin, vincristine and prednisone (CHOP) administered every 3 weeks for 8 cycles in patients with T-cell lymphoma
16214561|NCT01280513|Dietary Supplement|High protein intake|30% of energy intake coming from proteins
16214562|NCT01280513|Dietary Supplement|Low Protein intake|9% of energy intake coming from proteins
16214563|NCT01280500|Behavioral|electronic medical record|Decision Support, Asthma Action Plans, and Population Management Reporting (EAP)
16214564|NCT01280500|Other|Integrated Approach to Care|Patients within the IAC group will also receive their own copy of an asthma action plan to allow for some degree of self-management support. In addition, IAC practices receive assistance from a practice coach trained in practice redesign and rapid cycle process improvement.
16214565|NCT01280500|Other|usual care|No EMR
16214566|NCT01280500|Other|Shared Decision Making|The research team will develop the SDM intervention during the first 6 months of the study. The team will model this intervention on the randomized control trial performed by Dr. Sandra Wilson and colleagues within the Kaiser Permanente Clinics in California and Oregon
16214567|NCT01280500|Other|school based care|the research team will start an electronic data capture system linking school data and the clinical EMR (Cerner Power Chart) that will be implemented over the first year. Flow of data between schools and the hospital system will allow the children who have a regular source of care as well as those without a medical home to be treated with a unified asthma program by the school nurse and the hospital system.
16214570|NCT01280409|Drug|Placebo|Subjects will receive a placebo (similar in size, taste, color) once daily for 7 days, then twice daily for the next 5 weeks.
16214571|NCT01280383|Device|non-invasive neurally adjusted ventilatory assist|non-invasive neurally adjusted ventilatory assist in critically ill patients
16214572|NCT01280370|Procedure|Abdominal surgery|intraoperative mesh implantation
16214573|NCT01280357|Device|Monica AN24 (K101081)|If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM
16214574|NCT01280357|Device|Philips 50XM|If not confident of Monica AN24 displayed data then remove Monica AN24 monitor and continue monitoring with Philips 50XM
16214575|NCT01280344|Drug|Saline Solution for Injection|Intravenous (IV)
16214576|NCT01280344|Drug|Ipamorelin|Intravenous (IV)
16214577|NCT01280331|Drug|Q8003 (morphine sulfate and oxycodone hydrochloride)|Two Q8003 6 mg/4 mg IR Capsules q6h
16214578|NCT01280331|Drug|Morphine sulfate|Two morphine sulfate 12 mg IR capsules q6h
16214579|NCT01280331|Drug|Oxycodone HCl|Two oxycodone HCl 8 mg IR Capsules q6h
16214580|NCT01280318|Procedure|head and neck surgery|Blood Sample of biomakers at 3 days, 5 weeks and 3 months after surgery.
16214581|NCT01280305|Drug|raloxifene|raloxifene 60 mg bid
16214582|NCT01280305|Drug|placebo|Placebo bid
16214583|NCT01280292|Drug|Eltroxin|Eltroxin dosage titration according to free T4 measurement every 3 months
16214584|NCT01280279|Other|education for behavioral modification|a systematized 30-minutes education program for behavioral modification (SBMP) by watching videos and discussion with a specialized continence nurse practitioner.
16214585|NCT01280266|Drug|Udenafil or Amlodipine|Amlodipine 10mg daily then Udenafil 100 mg daily OR Udenafil 100 mg daily then Amlodipine 10mg daily
16214586|NCT01280240|Drug|Monofer(R)|Intravenous bolus injection given over app. 2 minutes only once
16214587|NCT01280227|Behavioral|SiSom|SiSom is a symptom assessment tool designed to help the child report disease specific problems.The child also report the severity of their problems. After using the tool a report is printed and given to the clinician.
16214588|NCT01280214|Drug|Triamcinolone|Subconjunctival and peribulbar, 40 mg/ml, 3 monthly injection
16214589|NCT01280201|Drug|Pazopanib|Single arm of pazopanib 800 mg (2x400mg) given once daily as a single agent.
16214590|NCT01280188|Drug|Desmopressin Oral Melt|Oral melt formulation starts on Day 2. The target initial dose of the orally disintegrating tablet is 180µg/day (60µg taken 3 times a day) and adjusted to optimally stabilise the participant's condition.
16214591|NCT01280188|Drug|Desmopressin intranasal|Self-administered intranasal desmopressin throughout the pre-study observation period (Days -30 to Day 0) and on study Day 1
16214592|NCT01280175|Procedure|charcoal block|
16214593|NCT01280175|Device|Aerochamber Plus spacer|
16214594|NCT01280175|Drug|pMDI standard actuator|
16214595|NCT01280162|Drug|Dihydroartemisinin piperaquine|40/320 mg tablets, 9 tablets total
16214596|NCT01280149|Biological|substance P|injections of substance P and low dose allergen or placebo
16214597|NCT01280149|Biological|substance P injections|injections of substance P for 8 weeks
16214598|NCT01280136|Behavioral|It's Your Game Tech|An interactive web-based intervention for 8th grade students. This web-based intervention will be adapted from the computer-based component of an existing successful prevention program, It's Your Game…Keep it Real, (IYG) as well as include critical elements from the IYG classroom component. The web-based intervention will consist of 13 lessons and will tailor information to the individual's gender and to his/her intentions or behaviors related to sexual risk-taking. The program will address peer norms, attitudes, self-efficacy, refusal skills, and communication skills related to healthy relationships, dating, and sexual risk-taking behavior.
16214599|NCT01280123|Drug|Pioglitazone|"Oral capsules of Pioglitazone (15 mg capsules) either 15 mg/qd or 45 mg/qd
~Subjects will titrate in a blinded fashion to 30 mg/day after 2 weeks and to 45 mg per day) 2 weeks later as tolerated."
16214600|NCT01280123|Drug|placebo|Placebo will contain microcrystalline cellulose. An over-encapsulation process will be conducted in accordance with Clinical Good Manufacturing Procedures (cGMP) regulations to create a dosage form for the active study drug that will be indistinguishable from the comparator (Placebo) capsule.
16214601|NCT01280110|Drug|Hydroxypropylmethylcellulose|22 patients will receive this lubricating drop 4 times a day for 1 month
16214602|NCT01280110|Drug|Carboxymethylcellulose|22 patients will receive this lubricating drop 4 times a day for 1 month.
16214603|NCT01280071|Drug|aminophylline|
16214604|NCT01280058|Drug|Carboplatin|Given IV
16214605|NCT01280058|Other|Laboratory Biomarker Analysis|Correlative studies
16214606|NCT01280058|Drug|Paclitaxel|Given IV
16214607|NCT01280058|Biological|Wild-type Reovirus|Given IV
16214608|NCT01280045|Procedure|VAGINAL HYSTERECTOMY|GOSERELINE ACETATE 10.8 MG FOR THREE MONTHS; ANASTROZOL ACETATE FOR THREE MONTHS
16214609|NCT01280032|Radiation|intraoperative radiotherapy|intraoperative radiotherapy (8 Gy) during kyphoplasty for spinal metatsases
16214610|NCT01280019|Procedure|alveolar recruitment manoeuvre|Increase of airway pressures in a stepwise manner from set peak inspiratory pressure/ positive end-expiratory pressure up to 40/15 mbar and back over 2 minutes.
16214611|NCT01280006|Other|Intermittent hypoxia|The subjects will receive five days of drug intervention: either non-selective cyclooxygenase (Indomethacin) or selective cyclooxygenase-2 inhibition (Celecoxib) or placebo. On the testing day, the subjects will undergo an acute intermittent hypoxia testing before and six hours of hypoxic chamber exposure mimicking obstructive sleep apnea syndrome.
16214612|NCT01280006|Drug|Indomethacin|"The subjects will receive five days of drug intervention: either non-selective cyclooxygenase (Indomethacin) or selective cyclooxygenase-2 inhibition (Celecoxib) or placebo. Then they will be tested with an exposure of intermittent hypoxia.
~Indomethacin: 50 mg, Oral, three times per day for five days."
16214613|NCT01280006|Drug|Celecoxib|"The subjects will receive five days of drug intervention: either non-selective cyclooxygenase (Indomethacin) or selective cyclooxygenase-2 inhibition (Celecoxib) or placebo. Then they will be tested with an exposure of intermittent hypoxia.
~Celecoxib: 200 mg, Oral, two times per day for five days with a visually matching sequential placebo in between of two doses."
16214648|NCT01279681|Drug|oxaliplatin|Given IV
16214649|NCT01279668|Drug|Montelukast|10mg tablets, once per day for 28 days.
16214614|NCT01280006|Drug|Placebo|"The subjects will receive five days of drug intervention: either non-selective cyclooxygenase (Indomethacin) or selective cyclooxygenase-2 inhibition (Celecoxib) or placebo. Then they will be tested with an exposure of intermittent hypoxia.
~Placebo: Oral, three times per day for five days."
16214615|NCT01279993|Procedure|Kerato refractive Surgery|This interventional case series was performed on 297 eyes of 150 patients who were candidates for PRK. Complete ophthalmic evaluations focusing on orthoptic examinations were performed before and 3 months after PRK.
16214616|NCT01279980|Other|Epidural|Epidural analgesia inserted prior to surgery to stay in until at least the second postoperative day
16214617|NCT01279980|Other|Local anaesthetic wound catheter|The catheter will be used to infuse the wound with local anaesthetic for 48 hours post op.
16214618|NCT01279967|Drug|ADI-PEG 20|36.8mg/m2 based on BSA, weekly treatment for 6 months
16214619|NCT01279954|Drug|Abatacept|"Subjects will receive approximately 10 mg/kg rounded to the nearest 25 mg for the first 6 months of the trial. At 6 months subjects will then be randomized to receive either 5 mg/kg or 10 mg/kg.
~Abatacept will be administered as a 30-minute intravenous infusion. Following the initial administration, abatacept will be given at 2 and 4 weeks after the first infusion and every 4 weeks thereafter for up to 2 years."
16214620|NCT01279941|Behavioral|Behavioral: Team-based intervention|The intervention involves a scripted peer-taught interactive curriculum, which is delivered as twelve, one-hour weekly sessions incorporated into a team's usual work time activities, with four follow-up booster sessions after twelve months.
16214621|NCT01279928|Procedure|Video Nailfold Capillaroscopy|Single session of video Nailfold Capillaroscopy wit KKK technology
16214622|NCT01279928|Device|Ambulatory 24 hr Blood Pressure Monitoring|24 hr upper arm cuff measurement of Blood Pressure
16214623|NCT01279928|Procedure|Fundoscopy of eyes|examination of microvascular health of eye with the use of opthalmoscope
16214624|NCT01279928|Procedure|Laser Doppler Flowmetry|Examination of vascular flow
16214625|NCT01279915|Drug|ASP0456|oral
16214626|NCT01279915|Drug|Placebo|oral
16214627|NCT01279902|Drug|Rituximab plus CHOP Immunochemotherapy|The R-CHOP treatment will continue up to 3 cycles with interval of 21 days: Each cycle consists of rituximab 375mg/m2 (iv, on day 1), cyclophosphamide 750 mg/m2 (iv, on day 1), doxorubicin 50mg/m2 (iv, on day 1), vincristine 1.4mg/m2 (iv, on day 1), and prednisolone 100mg (po, on day 1-5).
16214628|NCT01279876|Drug|Melatonin|3mg oral, daily, one hour before sleep
16214629|NCT01279850|Drug|Pregabalin (Lyrica) capsule|"Lyrica® Capsules depending on the investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dosage for oral use begins at 150 mg/day of pregabalin in twice daily, and should be gradually increased to 300 mg/day over 1 week or more and should be orally administered twice daily. Dosage should be adjusted, depending on age or symptoms. However, the daily maximum dose should not be beyond 600 mg, and should be orally administered twice daily."
16214630|NCT01279837|Behavioral|Pharyngocise|swallowing intervention by a speech language pathologist, consisting of the battery of isometric / isotonic exercises
16214631|NCT01279824|Behavioral|swallowing therapy|Standardized behavioral swallowing intervention
16214632|NCT01279811|Other|Crossover of vasopressors|"To evaluate the effect of different vasopressor agents on SCPP, a crossover intervention will be conducted on patients requiring either NORepinephrine or DOPamine post-operatively, once daily for 5 days while the catheter is in place. A subject on NORepinephrine will be switched over to DOPamine for 1 hr, and then switched back to NORepinephrine. Likewise, a subject on DOPamine will be switched over to NORepinephrine for 1 hr, and then switched back to DOPamine. Subjects on both vasopressors will have DOPamine stopped for 1 hr and NORepinephrine titrated up to maintain the same MAP for 1 hr, and then brought back to the original levels of both vasopressors. On the following day, the reverse will be carried out, with a stoppage of the NORepinephrine and maintenance solely on DOPamine."
16214633|NCT01279798|Biological|Lucanix® (belagenpumatucel-L)|Subjects will receive up to 12 monthly (28-35 day interval) Lucanix injections at a dose of 2.5 × 10e7 cells per injection.
16214634|NCT01279785|Drug|123I-MIP-1072|Single IV dose
16214635|NCT01279746|Device|Ultrasound compression of femoral and popliteal veins|Bedside ultrasound compression of femoral and popliteal veins.
16214636|NCT01279733|Genetic|Microarray analysis|"Microarray performed on prenatal specimen:
~Fluorescence in-situ hybridization (FISH) or other standardized tests such as qPCR or MLPA will be performed on the fetal sample to confirm abnormal MA findings of known and unknown clinical significance which are discordant with CC findings, including anomalies normally detected by karyotyping.
~Microarray analysis of DNA from parental blood samples will be used to determine whether CNVs detected in a fetal sample are also present in a healthy parent, in which case no further evaluation will take place, moreover any finding in a fetus which is duplicated in a parental microarray is considered to be confirmed."
16214637|NCT01279720|Biological|Intravenous infusion of transduced cells|Intravenous infusion of transduced cells
16214638|NCT01279707|Biological|humanised monoclonal antibody, veltuzumab|Veltuzumab with modified UKALL XII induction chemotherapy. Veltuzumab will be administered at 200 mg/m2 IV on Day 8 and subsequently, (if tolerated on Day 8), over 1 hour on Days 15, 22, 29.
16214639|NCT01279707|Biological|humanised monoclonal antibody epratuzumab|Epratuzumab with modified UKALL XII induction chemotherapy. Epratuzumab will be administered at 360 mg/m2 IV over 1 hour on Days 8, 15, 22 and 29.
16214640|NCT01279707|Biological|humanised monoclonal antibodies veltuzumab and epratuzumab|Epratuzumab + Veltuzumab with modified UKALL XII induction chemotherapy. Epratuzumab will be administered at 360 mg/m2 IV over 1 hour on Days 8, 15, 22 and 29. Veltuzumab will be administered at 200 mg/m2 IV over 2 hours on Day 8 and over 1 hour on Days 15, 22 and 29. Veltuzumab will be infused 1 hour after the infusion of epratuzumab.
16214641|NCT01279694|Drug|Carfilzomib|There are 9 cycle of 20mg/m²,Intravenous for J1, J2, J8, J9, J22, J23, J29 and 30 days with 12 days rest (42 day cycle) for the first cohort; or 20mg/m²,Intravenous for J1, J2, and 27 mg/m² for J8, J9, J22, J23, J29 and 30 days with 12 days rest (42 day cycle) for the second cohort for the last, third cohort 20mg/m²,Intravenous for J1, J2, and 36 mg/m² for J8, J9, J22, J23, J29 and 30 days with 12 days rest (42 day cycle)and the fourth cohort 20mg/m²,Intravenous for J1, J2, and 45 mg/m² for J8, J9, J22, J23, J29 and 30 days with 12 days rest (42 day cycle). .
16214642|NCT01279694|Drug|Melphalan|from 9 cycle: 9 mg/m²/day PO from day 1-4
16214643|NCT01279694|Drug|Prednisone|from 9 cycle: 60 mg/m²/day PO from day 1-4
16214651|NCT01279655|Device|tDCS|20 min, 1mA, 8 weeks (5 days a week, 20 min a day)
16214652|NCT01279655|Behavioral|Bimanual Training|The training program consisted of a bimanual etch-a-sketch task. By rotating two wheels subjects have to match a line presented on the screen with the cursor. 8 weeks (5 days a week, 20 min a day)
16214653|NCT01279642|Device|ultrasound|Doppler vascular ultrasound guidance to PICC insertion in children -
16214654|NCT01279642|Other|traditional puncture|traditional approach of PICC insertion by visualization and inspection of insertion site
16214655|NCT01279629|Drug|Each patient will receive a sample of the drug test (tazarotene 0.1%) and a control sample of the drug (calcipotriene 0.005%).|Apply the medication once daily, preferably at night, in quantities sufficient to cover only the lesions with a thin layer of the product (an average of 2 mg/cm2).Apply only in lesions of the right hemisphere.
16214656|NCT01279616|Drug|Fludarabine monophosphate|180 mg/m2 over 6 days.
16214657|NCT01279616|Drug|Rituximab|375 mg/m2 on day -13 and day -3
16214658|NCT01279616|Drug|Busulfan|AUC 1000-1200 microM.mt
16214659|NCT01279616|Drug|ATG|2.5 mg/kg for 3 days
16214660|NCT01279616|Drug|Cyclophosphamide|50 mg/kg on day +3
16214661|NCT01279616|Drug|Mycophenolate mofetil|15 mg/kg q 8 hours
16214662|NCT01279616|Drug|Tacrolimus|0.03 mg/kg /d
16214663|NCT01279603|Drug|GO-203-2c|GO-203-2c Injection is a non-preserved, sterile, ready-to-use liquid dosage form provided in a glass vial with rubber closure and crimp seal. Injection will be added to the contents of an intravenous bag (of 0.9% NS, D5W or sterile water) to a final concentration of between 0.03 - 0.3 mg/ml (preferable in 100 mls or greater) and administered as a single agent intravenously over 60 minutes. A treatment cycle will consist of a daily IV dose administered for 21 consecutive days followed by a 7 day rest.
16214664|NCT01279590|Drug|PPD10558|"PPD10558 40 mg capsule and matching placebo capsule twice a day for 4 weeks, then
~PPD10558 80 mg (two 40 mg capsules) twice a day for 8 weeks"
16214665|NCT01279590|Drug|Atorvastatin|"Atorvastatin 40 mg capsule and matching placebo capsule in the morning and 2 placebo capsules in the evening for 4 weeks, then
~Atorvastatin 80 mg (two 40 mg capsules) in the morning and 2 placebo capsules in the evening for 8 weeks"
16214666|NCT01279590|Drug|Placebo|2 placebo capsules twice daily for 12 weeks
16214667|NCT01279577|Drug|Low dose TSO|Low dose TSO suspension
16214668|NCT01279577|Drug|Medium dose TSO|Medium dose TSO suspension
16214669|NCT01279577|Drug|High dose TSO|High dose TSO suspension
16214670|NCT01279577|Drug|Placebo|Placebo solution
16214671|NCT01279564|Device|ETview TVT endotracheal tube|intubation
16214672|NCT01279564|Device|Endotracheal tube|Intubation
16214673|NCT01279551|Drug|0.4% nitroglycerin ointment|Local endoanal application 2 times a day
16214674|NCT01279551|Drug|lidocaine cloridrato 2.5% ointment|Local endoanal application of lidocaine cloridrato 2.5% ointment 2 times a day
16214675|NCT01279538|Drug|bleselumab|Intravenous (IV) infusion
16214676|NCT01279538|Drug|Placebo|Intravenous (IV) infusion
16214677|NCT01279525|Device|multifactorial|individual advice, information leaflet, physical exercise workshop and home visits
16214678|NCT01279512|Drug|Metformin|The metformin dose will be 500 mg/ day in the first week, 1000 mg/ day in the second week and 1500 mg/ day for the next 10 weeks.
16214679|NCT01279512|Drug|Acarbose|Acarbose group will be treated by acarbose (its dose will be 100 mg/day in the first week, 200 mg/ day in the second week and 300 mg/ day for the next 10 weeks).
16214680|NCT01279499|Drug|Sevoflurane|Intraoperatively Sevoflurane will be guided by a target end tidal concentration 1 - 2 MAC .Every rise of BP or HR > 15% of baseline will be followed by a bolus SEVO inhalation 8% MAC for 2 minutes
16214681|NCT01279499|Drug|Sevoflurane|Intraoperatively sevoflurane will be guided by a target BIS of 40 - 50. If a positive sympathetic response occured (an elevation of the HR and/or MAP greater than 15% above baseline) a bolus SEVO 8 MAC will be administered for 2 minutes.
16214682|NCT01279499|Drug|Propofol- Remifentanyl|"Anaesthesia will be induced with a continuous IV Propofol infusion (21mg/kg TBW for 5 min, 12 mg/kg TBW for 10 min and then 6 mg/kg TBW), followed by an IV bolus of Remifentanyl (1 μg/kg IBW) and succinylcholine (1mg/kg IBW).General anesthesia will be maintained with continuous intravenous administration of Propofol at 150-300mcg/kg/min (doses based on ideal body weight).
~Every rise of BP or HR > 15% of baseline will be followed by a Remifentanyl bolus IV (1 μg/kg IBW) and increase in the continuous infusion rate of Remifentanyl from 0.1 to 1.0 μg/kg/min"
16214683|NCT01279499|Drug|Propofol, Remifentanyl|"Anaesthesia will be induced with a continuous IV Propofol infusion (21mg/kg TBW for 5 min, 12 mg/kg TBW for 10 min and then 6 mg/kg TBW), followed by an IV bolus of Remifentanyl (1 μg/kg IBW) and succinylcholine (1mg/kg IBW). General anesthesia will be maintained with continuous intravenous administration of Propofol at 150-300mcg/kg/min (ideal body weight).
~The depth of anesthesia will be adjusted so as to accomplish a BIS score between 40 and 50 Every rise of BP or HR > 15% of baseline will be followed by a Remi bolus IV (1 μg/kg IBW) and increase in the continuous infusion rate of Remi from 0.1 to 1.0 μg/kg/min"
16214684|NCT01279473|Drug|Nilotinib|
16214685|NCT01279447|Drug|0.25% Bupivacaine|10cc, single dose, US guided injection
16214686|NCT01279447|Drug|Normal Saline|10cc, single dose, US guided injection
16214687|NCT01279434|Drug|Vitamin E plus Pentoxiphyllin|Both drugs will be administered daily Vit E (400 mg BD) and pentoxiphyllin (400 mg TDS) for 12 months
16214688|NCT01279434|Drug|Vitamin E|Vitamin E 400 mg BD daily for 12 months
16214689|NCT01279421|Behavioral|Social Network HIV Testing|Crack users will be recruited for HIV testing and receive 3 coupons to recruit other crack users for HIV testing.
16214690|NCT01279421|Behavioral|Peer Network Intervention|Peer leaders will recruit small networks of crack users and facilitate a three-day prevention intervention.
16214691|NCT01279408|Other|None: Questionnaire Study|Patients enrolled in this study will have standard treatment as per the discretion of their attending physician. The only additional requirement is that they would be asked is to complete questionnaires
16214692|NCT01279382|Behavioral|Hypnotherapy (HYP)|Hypnotherapy was given to a subgroup of patients as intervention in IBS treatment
16214693|NCT01279382|Behavioral|Relaxation training (RT)|RT was given to a subgroup of patients as intervention in IBS treatment
16214694|NCT01279382|Other|Care as usual (CON)|CON was given to a subgroup of patients as control intervention in IBS treatment
16214695|NCT01279343|Device|Foley bulb|This is a randomized trial comparing foley bulb with the use of misoprostol versus use of misoprostol alone for cervical ripening and labor induction.
16214696|NCT01279330|Other|Co-signed Letter|Patients receive a personalized stimulus letter co-signed by their general practitioner and the medical coordinator of ADECA.
16214697|NCT01279330|Other|Control|No intervention (Patients receive by mail the materials needed for stool samples).
16214698|NCT01279317|Dietary Supplement|placebo co-ingestion|25 ml water co-ingested with a glucose-containing beverage
16214699|NCT01279317|Dietary Supplement|vinegar co-ingestion|25 ml vinegar (1 g acetic acid) co-ingested with a glucose-containing beverage
16214700|NCT01279304|Radiation|radiation - no radiation see intervention description|after MRM in group 1 (low risk): no radiotherapy after BCT in group 1 (low risk): radiation treatment of the breast with boost (optional)
16214701|NCT01279304|Radiation|radiation: see intervention description|after BCT in group 2 (intermediate risk): radiation treatment of the breast with boost (optional) after MRM in group 2 (intermediate risk): radiation treatment of the thoracic wall If no full ALND is performed in group 2 (intermediate risk) add radiation treatment of level 1 and 2 of the axilla.
16214702|NCT01279304|Radiation|radiation: see intervention description|after MRM in group 3 (high risk): radiation treatment of the thoracic wall and supraclavicular nodes after BCT in group 3 (high risk): radiation treatment of the breast with boost (optional) and supraclavicular nodes If no full ALND is performed group 3 (high risk) add radiation treatment of level 1 and 2 of the axilla.
16214703|NCT01279291|Biological|KHK2866|Potentially therapeutic monoclonal antibody for the treatment of advanced cancer and ovarian cancer.
16214704|NCT01279291|Drug|Gemcitabine and Carboplatin|Combination chemotherapy with KHK2866 to treat advanced platinum-sensitive ovarian cancer. Gemcitabine dose 1000 mg/m2, Carboplatin dose AUC=4
16214705|NCT01279291|Drug|paclitaxel|Combination chemotherapy with KHK2866 to treat advanced platinum-resistant ovarian cancer. Paclitaxel will be administered weekly at a dose of 80 mg/m2.
16214706|NCT01279291|Drug|pegylated liposomal doxorubicin|Combination chemotherapy with KHK2866 to treat advanced platinum-resistant ovarian cancer. PLD will be administered weekly at a dose of 40 mg/m2.
16214707|NCT01279278|Other|Co-signed letter|Patients receive a personalized letter co-signed by their general practitioner and the medical coordinator of ADECA.
16214708|NCT01279278|Other|Classical Letter|Patients receive classical letter signed by the coordinator doctor of ADECA
16214709|NCT01279265|Dietary Supplement|Nutramigen with Enflora|Hypoallergenic formula with probiotic - Lactobacillus GG
16214710|NCT01279265|Dietary Supplement|Nutramigen A+|Hypoallergenic formula without lactobacillus
16214711|NCT01279252|Drug|metronidazole, clarithromycin, ciprofloxacin and lansoprazole|
16214712|NCT01279226|Device|Auralevée device|Single treatment with Auralevée device.
16214713|NCT01279213|Drug|paliperidone clozapine|dose 3 to 12 mg paliperidone ER daily during 12 weeks
16214714|NCT01279200|Other|Midcycle ultrasound + hCG injection|Mid-cycle ultrasound with administration of hCG (single dose of standardized pre-filled injection, 250 mcg, at time of ultrasound) when appropriate.
16214715|NCT01279200|Other|Urinary LH kits|Subjects randomized to monitoring with LH kits at home will keep a monthly calendar documenting when LH testing begins, day LH surge occurs and day(s) of intercourse/insemination.
16214716|NCT01279187|Drug|Teriparatide|20ug per day,via subcutaneous injection, for 7 weeks
16214717|NCT01279187|Drug|Placebo|20ug per day, self administered injection, for 7 weeks
16214718|NCT01279174|Other|Conventional physiotherapy|Patients in this study group will attend physiotherapeutic exercise sessions of one hour three times a week for six weeks. The sessions consist of aerobic and muscle strengthening as well as coordination exercises. Patients will practice activities of daily living. The goals of these exercises are to improve joint stability, optimize knee and ankle proprioception, and advance neuromuscular innervation of the lower extremity and thereby suppress pathologic motion patterns. This should lead to optimized mobility, increased stability, and thus more endogenous analgesia of the affected joint
16214719|NCT01279135|Radiation|Conventional Radiation|Standard Pelvic Radiation 50 Gy/ 25 fractions over 5 weeks
16214720|NCT01279135|Radiation|Tomotherapy based IGRT|Patients in this arm will received Tomotherapy based Image Guided Intensity Modulated Radiotherapy to a dose of 50 Gy/25 fractions/5 weeks
16214721|NCT01279122|Device|Nanoflex IOL|Patients who were implanted with the Nanoflex IOL
16214722|NCT01279109|Behavioral|Social network building intervention|Group support and 12 weekly health education/skills building sessions during pregnancy
16214723|NCT01279109|Behavioral|Home visit|Three home visits during pregnancy focused on providing education on infant injury prevention
16214724|NCT01279096|Drug|Clofarabine|escalating doses of clofarabine starting from 20 mg/m2/day to 40 mg/m2/day from day 1 to day 5 used in association with etoposide, asparaginase, mitoxantrone and dexamethasone
16214725|NCT01279083|Drug|DE-112|Topical ocular solution
16214726|NCT01279083|Drug|DE-112|Topical ocular solution
16214727|NCT01279083|Drug|DE-112|Topical ocular solution
16214728|NCT01279083|Drug|DE-112|Topical ocular solution
16214729|NCT01279083|Drug|DE-112 Vehicle Solution|Topical ocular solution
16214730|NCT01279083|Drug|Timolol Maleate Solution|Topical ocular solution
16214731|NCT01279070|Behavioral|Repyflec cognitive remediation training|Comparison of 32 Repyflec group sessions among 32 leisure group sessions where we stimulated non-specific cognitive perform.
16214732|NCT01279057|Drug|Fluticasone furoate 27.5 mcg/actuation nasal spray (Lek Pharmaceuticals)|Nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.
16214733|NCT01279057|Drug|Fluticasone furoate (Veramyst®) 27.5 mcg/actuation nasal spray|Nasal spray administered once daily at a dose of 110 mcg (4 actuations) for 14 days.
16214734|NCT01279057|Drug|Placebo|Placebo nasal spray administered once daily (4 actuations) for 14 days.
16214735|NCT01279044|Behavioral|Adapted Personalized Cognitive Risk-reduction Counseling intervention (PCC)|The individualized, cognitive counseling intervention was designed to help participants address the self-justifications-beliefs, thoughts, and attitudes-that they employed in the setting of high-risk sexual behavior, in the company of an empathic counselor.
16214736|NCT01279044|Behavioral|Standard HIV testing with information only|Standard HIV testing with information only
16214737|NCT01279031|Device|Abbott WHITESTAR Signature System with Ellips Transversal Ultrasound|Comparison of vision after cataract surgery based on two different types of equipment.
16214738|NCT01279031|Device|Alcon Infiniti wiht the OZIL Torsional Handpiece|Comparision of vision after cataract surgery based on two different types of equipment.
16214739|NCT01278992|Dietary Supplement|Rhodiola rosea|1 capsule = 182 mg Rhodiola rosea extract standardized to 2.8% total rosavins. Take 2 capsules at start of wakeful period each day. Participants will self-determine need for second dose, of 1 capsule, within 4 hours of the initial dose.
16214740|NCT01278979|Device|"Objective measurements of perineal tears with Peri-Rule"|"Four measurements will be used in this study.
~Depth of tear, from the fourchette into the greatest depth of the perineal body.
~Length of tear, from the fourchette to the apex of the vaginal tear.
~Length of tear, from the fourchette along perineal skin towards the anus.
~Length of the perineal body, from the fourchette to outer margin of anus."
16214741|NCT01278979|Other|Visual and digital assessment|Midwifes assessing perineal tears as standard procedure with visual and digital examination of the perineal tear.
16214742|NCT01278966|Other|The Modified Atkins Diet|The Modified Atkins Diet; 10 g carbohydrate per day and a high fat intake
16214743|NCT01278953|Device|Catheter ablation to treat paroxysmal atrial fibrillation|A pulmonary vein isolation procedure will be performed using radiofrequency ablation.
16214744|NCT01278940|Biological|Dendritic Cells (DC) malignant melanoma|The patients were assigned to intradermal or intranodal DC vaccination
16214745|NCT01278940|Procedure|IL-2|IL-2 were administrated by intranodal injection
16214746|NCT01278927|Behavioral|Exercise|Participants assigned to the Exercise arm will receive a packet of materials from the study interventionist, along with a brief personalized introduction to the home-based exercise intervention.
16214747|NCT01278927|Behavioral|Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (10 minute) standardized introduction to the self-administered intervention.
16214748|NCT01278927|Behavioral|Exercise and Stress Management|Participants will receive a packet of materials from the study interventionist, along with a brief (15 minute) personalized introduction to the interventions.
16214749|NCT01278927|Other|Standard Care|Patients randomized to standard care only will be informed of their assigned condition and receive the DVD.
16214750|NCT01278914|Biological|Dendritic Cells (DC) prostate|
16214751|NCT01278888|Procedure|Anterolateral thoracotomy|Standard anterolateral thoracotomy
16214752|NCT01278888|Procedure|Posterolateral thoracotomy|Standard muscle sparing posterolateral thoracotomy
16214753|NCT01278888|Procedure|VATS|Standard video assisted thoracic surgery, no use of rib-spreader.
16214754|NCT01278888|Procedure|Anterolateral Thoracotomy|Standard anterolateral thoracotomy
16214755|NCT01278862|Device|DVS veneer|CAD/CAM milled porcelain veneer for Lava crown
16214756|NCT01278862|Device|Conventional Veneer|CAD/CAM milled Lava crown with lab fabricated veneer
16214757|NCT01278849|Drug|ASA404|
16214758|NCT01278836|Procedure|fasciocutaneous flap|flaps which include skin, subcutaneous tissue, and the underlying fascia.
16214759|NCT01278823|Procedure|laparoscopic roux en y gastric bypass operation|roux en y gastric bypass operation
16214760|NCT01278823|Other|medical management|latest type 2 diabetes medications, lifestyle/behavior modification and dietary regimen
16214761|NCT01278810|Drug|Icaritin|50mg,100mg,200mg,300mg,400mg,500mg ascending-multiple oral dose, Qd, single dose and continuing dose 28 days, to assess the safety,tolerance and pharmacokinetics of icaritin
16214762|NCT01278797|Drug|Telmisartan/Amlodipine Combination Tablet|Combination Tablet
16214763|NCT01278797|Drug|Amlodipine Monocomponent|Active Comparator
16214764|NCT01278784|Device|0.05% Chitosan-N-Acetylcysteine eye drops|Subjects will be randomized to receive one drop of the medical device in either the right or left eye
16214765|NCT01278784|Device|0.1% Chitosan-N-Acetylcysteine eye drops|Subjects will be randomized to receive one drop of the medical device in either the right or left eye
16214766|NCT01278758|Drug|ASA404, DMXAA or DXAA|
16214767|NCT01278745|Biological|Rituximab induction/conventional immunosuppression (tacrolimus, MMF, and steroid taper)|
16214768|NCT01278745|Drug|Rituximab placebo/conventional immunosuppression (tacrolimus, MMF, and steroid taper)|
16214769|NCT01278732|Other|no intervention performed|no intervention is performed
16214770|NCT01278706|Procedure|endometrial biopsy/ies|performing office endometrial biopsy with a disposable sterile catheter
16214771|NCT01278693|Drug|L-carnitine|500 mg,twice daily, 16 weeks
16214772|NCT01278693|Drug|placebo|500 mg,twice daily, 16 weeks.
16214773|NCT01278680|Behavioral|Incentives for walkstation usage|The investigators are testing the effect of two different incentive schemes on people's usage of walkstations at work: either a personal incentive (in which people receive personal financial benefit for using the walkstations) vs. a charitable incentive (in which others receive financial benefit if a given individual uses the walkstation).
16214774|NCT01278654|Behavioral|Incentive to exercise|Participants who attain their walkstation goal will be entered into a draw every two weeks. We are testing the effect of different prizes on walkstation usage.
16214775|NCT01278641|Behavioral|Graded strength resistance training program|Graded strength resistance training, 75 minutes, twice a week for 12 weeks.
16214776|NCT01278641|Behavioral|Temperate pool exercise program|Temperate pool low intensive exercise, 50 minutes, twice a week for 12 weeks.
16214777|NCT01278628|Other|exercise training|exercise class once a year
16214778|NCT01278615|Other|Laboratory Biomarker Analysis|Correlative studies
16214779|NCT01278615|Drug|Selumetinib|Given PO
16214780|NCT01278602|Drug|R-ESHAP|Rituximab 375mg/m2 at day 0, Meththylprednisolone 500mg IV at days 1 to 5, Etoposide 40mg/m2 at days 1 to 4, Cisplatin 25mg/m2 at days 1 to 4, Cytarabine 2000mg/m2 at day 5. Frequence of cycles: every 3 weeks. Numbers of cycles: 3 cycles.
16214781|NCT01278589|Dietary Supplement|Plantago asiatica L. extract 5g|Liquid (80g) containing Plantago asiatica L. extract 5g
16214782|NCT01278589|Dietary Supplement|Plantago asiatica L. extract 10g|Liquid (80g) containing Plantago asiatica L. extract 10g
16214783|NCT01278589|Dietary Supplement|Plantago asiatica L. extract 20g|Liquid (80g) containing Plantago asiatica L. extract 20g
16216943|NCT01262235|Drug|TKM-080301|Repeat dose IV infusion.
16214784|NCT01278589|Dietary Supplement|Placebo|Liquid (80g) without Plantago asiatica L. extract
16214785|NCT01278576|Drug|BOTOX-A®|200 units, single treatment only
16214786|NCT01278563|Behavioral|Low glycemic index diet|dietitian interview and counselling for the low glycemic index diet group
16214787|NCT01278537|Behavioral|Information|Booklet, motivational interviewing, brief advice
16214788|NCT01278511|Other|Canadian C-Spine rule|Emergency medicine undergraduates will accompany prehospital emergency crews and apply the Canadian C-Spine rule, though cervical collar will be applicated per current protocol.
16214789|NCT01278498|Drug|Escitalopram|first week:5mg 2nd week~12 week:10mg
16214790|NCT01278498|Drug|sugar pill|first week:5mg 2nd week~12 weeks:10mg
16214791|NCT01278485|Drug|Sulphonylurea|SU administered according to usual practice.
16214792|NCT01278485|Drug|Metformn|Metformin administered according to usual practice.
16214793|NCT01278472|Device|Single Port Cholecystectomy|Using transumbilical single port device: SILS Port
16214794|NCT01278472|Device|4 Port Cholecystectomy|using 4 separate skin incisions and 2 5mm and 2 12 mm conventional ports
16214795|NCT01278459|Drug|Atorvastatin|4 week treatment, 20mg/day taken orally in tablet form
16214796|NCT01278446|Other|Extensively hydrolyzed, whey protein infant formula|New hydrolyzed formula
16214797|NCT01278446|Other|Extensively hydrolyzed, casein protein infant formula|Commercially available hydrolyzed infant formula
16214798|NCT01278433|Biological|IMOVAX Polio™: Inactivated Poliomyelitis Vaccine|0.5 mL, Intramuscular
16214799|NCT01278420|Device|Tecnis MF|30 subjects will be implanted with the Tecnis MF
16214800|NCT01278420|Device|ReSTOR|30 subjects will be implanted with ReSTOR
16214801|NCT01278407|Drug|Donepezil 5 mg|Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg
16214802|NCT01278407|Drug|Donepezil 10 mg|Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg and then the dose was increased to 10 mg
16214803|NCT01278407|Drug|Donepezil matched placebo|
16214804|NCT01278394|Drug|AN2690 Solution, 5.0%|Once daily application for 360 days
16214805|NCT01278381|Procedure|Pancreaticoduodenectomy|Resection of pancreatic lesion
16214806|NCT01278368|Procedure|Pancreatic resection after preoperative chemotherapy|Pancreatic resection after preoperative chemotherapy
16214807|NCT01278368|Procedure|Pancreatic resection|Pancreatic resection
16214808|NCT01278355|Device|Ear acupuncture|Ear acupuncture
16214809|NCT01278342|Drug|Sandostatin LAR|40 mg intramuscular (i.m.) every 28 days for 3 months
16214810|NCT01278342|Drug|pegvisomant|Weekly doses of pegvisomant 70 mg subcutaneously (s.c.) for 4 months given with Sandostatin LAR 40 mg intramuscular (i.m.) every 28 days for 4 months
16214811|NCT01278342|Drug|cabergoline|"Weekly cabergoline for 4 months, with weekly doses of Sandostatin LAR 40 mg intramuscular (i.m.) every 28 days for 4 months. Cabergoline doses as follows:
~st week: 0.25 mg twice a week (0.50 mg/week)
~nd week: 0.50 mg/week twice a week (1 mg/week)
~rd week: 0.50 mg four times a week (2 mg/week)
~th week: 0.50 mg daily (3.5 mg/week) Subsequent 3 months: 0.50 mg daily (3.5 mg/week)"
16214812|NCT01278329|Other|"Garbh Sanskar audio cassette (Times Music Inc., Mumbai, India)"|Approximate playing time = 50 minutes. Mothers advised to listen to it once every day.
16214813|NCT01278316|Behavioral|Control|Participants will be asked to perform computerized tasks that involve auditory and verbal performance one hour each day, five days per week for 8-10 weeks. Six tasks requiring auditory and verbal information will be presented.
16214814|NCT01278316|Behavioral|Cognitive Training|Participants will be asked to perform the Brain Fitness (PositScience) cognitive training tasks an hour each day, five days per week for 8-10 weeks. Six tasks manipulating auditory and verbal information will be presented, and stimuli from all tasks are presented auditorily. All tasks are designed to begin with the lowest level of difficulty required to attain 85% accuracy, and as performance improves, difficulty increases to maintain 85% accuracy, with difficulty decreasing if accuracy decreases.
16214815|NCT01278303|Device|Treatment of Aortic Wall Injury|A Cheatham covered platinum stent will be implanted in the Descending aorta to repair coarctation of the aorta in qualified patients.
16214816|NCT01278290|Diagnostic Test|Triptorelin acetate and Gonadorelin acetate|Triptorelin acetate test, using aqueous 0.1 mg/m2 subcutaneous. Gonadorelin test using 100 ug intravenous.
16214817|NCT01278290|Diagnostic Test|Gonadorelin acetate and Triptorelin acetate|Gonadorelin acetate intravenous 100 ug. Triptorelin acetate 100 ug/m2.
16214818|NCT01278277|Dietary Supplement|Saffron supplementation|Saffron supplementation 20 mg
16214819|NCT01278277|Other|placebo|placebo supplementation
16214820|NCT01278264|Drug|Ropivacaine 0.25%, 0.5 ml/kg|Posterior approach for TAP: ultrasound guided bilateral needle insertion in the transversus abdominis plane, anterior to the quadratus lumborum muscle
16214821|NCT01278264|Drug|Ropivacaine 0.25%, 0.5 ml/kg|Subcostal approach for TAP: US guided needle insertion in the transversus abdominis plane, lateral to rectus sheet
16214822|NCT01278251|Procedure|Distal Biceps Re-Insertion|
16214823|NCT01278238|Drug|Phenylephrine|Intravenous infusion Dosage 0,25 microgram/kg bodyweight as bolus, continuous infusion with 0,25 microgram/kg/min
16214824|NCT01278238|Device|Lower limb compression|Tight bandaging of lower extremity up to hips with compression bandages
16214825|NCT01278238|Other|Placebo|Neither phenylephrine nor lower limb bandaging
16214826|NCT01278225|Behavioral|EEG biofeedback (BF) Group|Group 1 will take part in a minimum of 2 neurofeedback training sessions each week for up to 10 weeks, for a total of up to 20 training sessions.
16214827|NCT01278225|Behavioral|Wait-List Control (WLC) Group|Group 2 will be placed on a wait-list, will continue to receive standard care, will not take part in the neurofeedback training, but will take part in the follow-up visits.
16214828|NCT01278225|Behavioral|Follow UP Questionnaires|After Group 1 completes neurofeedback training, both Groups to complete 10 questionnaires that were completed at baseline.
16214829|NCT01278212|Radiation|accelerated hypofractionated radiotherapy (AHF-RT)|30 Gy in 5 fractions once a week for 5 weeks, followed by optional boost of 10-16 Gy
16214874|NCT01277900|Procedure|Laparoscopic Roux en Y gastric Bypass|Laparoscopic Roux-en-Y gastric bypass will be used as a standard procedure to treat type 2 diabetes mellitus
16214920|NCT01277640|Drug|matched placebo|"dosage form: gel, no api
~dosage: 2.5g
~frequency: once daily
~duration: 7 days"
16214830|NCT01278199|Other|Medicals measures|"Rest in bed. Monitoring of respiratory frequency. Fixation of intravenous route. Administration of nasal oxygenotherapy in order to maintain SpO2 > 90%. Administration of antituberculosis treatment, in case with active pulmonary tuberculosis known at admission or diagnosed during the stay.
~If necessary a bronchial wash out of will be realized by a bronchial fibroscopy with measures of use of cold serum, adrenalin xylocain or terlipressin.
~The administration of antibiotherapy by general mode according to the clinician appreciation.
~The administration of terlipressin according to the clinician appreciation. Against the cough treatment administration according to the clinician appreciation."
16214831|NCT01278199|Other|bronchial artery embolization|The bronchial artery embolization is practised within 48 hours which follow the hospital admission for non-severe acute hemoptysis.
16214832|NCT01278186|Procedure|Balloon angioplasty|Coronary angioplasty using the paclitaxel-coated balloon catheter
16214833|NCT01278186|Procedure|Stent implantation|Coronary angioplasty using the paclitaxel-eluting stent
16214834|NCT01278173|Drug|Sabril|Sabril: 500 mg tablets, orally. Physicians will dose their patients according to guidance provided in the product label.
16214835|NCT01278160|Drug|biphasic insulin aspart 30|Administered subcutaneously (under the skin), twice daily with a dosage of 2/3 and 1/3 total daily dose before breakfast and before dinner, in combination with metformin.
16214836|NCT01278160|Drug|biphasic insulin aspart 30|Administered subcutaneously (under the skin), twice daily with a split dosage of 1/2 and 1/2 total daily dose before breakfast and before dinner, in combination with metformin.
16214837|NCT01278160|Drug|metformin|Tablets 500 mg administered orally with meals. Pre-trial dose and regimen unchanged
16214838|NCT01278147|Behavioral|fatigue education program|the carer will help the patient develop competences on the following points: how to evaluate the severity of the fatigue; learn to recognize symptoms or prodromes showing associated difficulties (anxiety, fear, depression); how to improve control of fatigue by setting up suitable strategies (management of periods of activity and rest, physical and/or intellectual exercises, dietary program, complementary therapy); learn to ask for and accept the help of close relations or carers.
16214839|NCT01278134|Drug|Copegus placebo|1000 mg or 1200 mg daily orally in split doses (morning/evening), up to 24 weeks
16214840|NCT01278134|Drug|RO5024048|1000 mg bid orally, up to 24 weeks
16214841|NCT01278134|Drug|danoprevir|100 mg bid orally, up to 24 weeks
16214842|NCT01278134|Drug|peginterferon alfa-2a [Pegasys]|180 mcg sc weekly, 24 weeks
16214843|NCT01278134|Drug|ribavirin [Copegus]|1000 mg or 1200 mg daily orally in split doses (morning/evening), up to 24 weeks
16214844|NCT01278134|Drug|ritonavir|100 mg bid orally, up to 24 weeks
16214845|NCT01278121|Dietary Supplement|Diet A|3 days, 6 meals a day
16214846|NCT01278121|Dietary Supplement|Diet B|10 days, 6 meals a day
16214847|NCT01278108|Drug|GLPG0778|single ascending doses, oral solution (10 to 800 mg/dose) and capsules (100 mg/dose)
16214848|NCT01278108|Drug|placebo|single dose, oral solution or capsule (matching corresponding study medication)
16214849|NCT01278108|Drug|GLPG0778|multiple dose, capsule, 7 days
16214850|NCT01278108|Drug|placebo|multiple dose, capsule, 7 days
16214851|NCT01278095|Drug|GLPG0555 solid dispersion|solid dispersion capsules, 50 mg, single dose
16214852|NCT01278095|Drug|GLPG0555 nanosuspension|Nanosuspension, 50 mg, single dose
16214853|NCT01278082|Drug|Budesonide|Alternating daily dosing with 2 x 3 mg budesonide capsules OD and 1 x 3 mg budesonide capsule OD every second day
16214854|NCT01278082|Drug|Placebo|Alternating daily dosing with 2 placebo capsules OD and 1 placebo capsule OD every second day.
16214855|NCT01278056|Drug|Exjade|Two dose escalating cohorts of oral administration in Phase I. Phase II: oral administration of the maximum tolerated dose.
16214856|NCT01278030|Procedure|3D echo-guided LV lead placement|Information about left ventricular mechanical dyssynchrony and the location of the site of latest mechanical activation based on RT3DE will be available to the physician from the core lab analysis. This location will be used as the target for optimal LV lead placement.
16214857|NCT01278017|Drug|ceftriaxone|ceftriaxone ,parenteral route, 50mg/kg/day divided twice
16214858|NCT01278004|Drug|Ethosuximide|Drug will be dose escalated in order to reach maximum tolerated dose starting with 250mg.
16214859|NCT01278004|Drug|Placebo|Capsule
16214860|NCT01277991|Drug|Treatment A|Single oral dose of 5 mg CP-690,550 administered as five 1 mg tablets (Phase 2B tablets)
16214861|NCT01277991|Drug|Treatment B|Single oral dose of 5 mg CP-690,550 administered as one 5 mg tablet (Phase 2B tablet)
16214862|NCT01277991|Drug|Treatment B|Single oral dose of 5 mg CP-690,550 administered as one 5 mg tablet (Phase 2B tablet)
16214863|NCT01277991|Drug|Treatment A|Single oral dose of 5 mg CP-690,550 administered as five 1 mg tablets (Phase 2B tablets)
16214864|NCT01277965|Other|50%VO2maxTBR50|The basal rate of the pump will be adjusted in accordance with the intensity of physical activity being performed for moderate physical activity (50% VO2max),a temporary basal rate will be reduced by 50%
16214865|NCT01277965|Other|50%VO2max TBR80|The basal rate of the pump will be adjusted in accordance with the intensity of physical activity being performed for moderate physical activity (50% VO2max),a temporary basal rate will be reduced by 80%
16214866|NCT01277965|Other|75%VO2max TBR80|The basal rate of the pump will be adjusted in accordance with the intensity of physical activity being performed for moderate physical activity (75% VO2max),a temporary basal rate will be reduced by 80%
16214867|NCT01277965|Other|75%VO2max TBR100|Turning off the pump (75%VO2max TBR100).However, in order to maintain the study blindfold, the pump will be switched off but not removed
16214868|NCT01277965|Other|Rest|Patient will be in rest, basal insulin flow rate will not be change
16214869|NCT01277952|Device|Deep Brain Stimulation|Brain pace maker, implanted in the brain
16214870|NCT01277939|Behavioral|Therapeutic Education System (TES)|Therapeutic Education System (TES) is an interactive, computer-based, psychosocial treatment program. TES is theoretically grounded in evidence-based psychosocial treatments (Community Reinforcement Approach and Cognitive Behavioral Therapy).
16214871|NCT01277939|Behavioral|Standard Care|Psycho-educational and psycho-social approaches to substance use disorders (commonly offered in prison settings) delivered by counselors in group formats.
16214872|NCT01277913|Drug|Vitamin D3|1000 IU once daily for 12 months
16214875|NCT01277887|Behavioral|Cognitive-Behavioral Counseling|The cognitive-behavioral intervention integrates standard smoking counseling adapted from the American Lung Association Freedom from Smoking program along with cognitive-behavioral techniques for improving insomnia.
16214876|NCT01277887|Behavioral|Smoking Cessation Counseling|The smoking cessation counseling intervention will incorporate standard psychoeducational and behavioral smoking counseling techniques adapted from the American Lung Association Freedom from Smoking program.
16214877|NCT01277874|Device|Nasal CPAP|NCPAP is delivered via nasal prongs placed into infant's nares. It may be delivered via ventilator or by bubble.
16214878|NCT01277874|Device|Oscillatory NCPAP|Bird Industries pneumatic diaphragm is attached to NCPAP patient circuit to provide oscillations.
16214879|NCT01277861|Drug|Fentanyl|FENTANYL PRETREATMENT DURING INDUCTION OF ANESTHESIA
16214880|NCT01277835|Drug|Lidocaine Infusion|Infusion of lidocaine 3mg/min or 2mg/min during surgery
16214881|NCT01277835|Drug|Placebo|Saline Infusion at same rate as experimental arm
16214882|NCT01277822|Drug|Losartan (+) amlodipine|One tablet containing 100 mg losartan potassium and 5 mg amlodipine camsylate, orally, once daily, for 8 weeks.
16214883|NCT01277822|Drug|Placebo to match losartan/amlodipine tablets|One tablet containing placebo, orally, once daily, for 8 weeks.
16214884|NCT01277822|Drug|Amlodipine camsylate|2 tablets each containing 5 mg amlodipine, orally, once daily, for 8 weeks.
16214885|NCT01277822|Drug|Placebo to match amlodipine|2 tablets containing placebo, orally, once daily, for 8 weeks.
16214886|NCT01277809|Behavioral|Interpersonal Interaction|Participants will receive stationary 1:1 interaction time with the same research personnel who conduct the third group walking session at each individual care facility in order to control for the interpersonal interaction likely to be involved in the walking program (Interpersonal Interaction Group; IIG). This group will receive the equivalent interpersonal interaction time with research personnel as those participating in the WPG group. This interaction time will occur with the participant stationary, rather than walking with the researcher.
16214887|NCT01277809|Behavioral|Walking Program|Participants will walk five times per week, supervised by a licensed physiotherapist. Subjects will in general gradually increase their daily supervised walking time as tolerated to a maximum of 30 minutes once per day. The distance and number of minutes walked each time will be recorded. Interpersonal interaction will occur during the walking sessions, and will be similar in quality and quantity to that during the Interpersonal Interaction Group.
16214888|NCT01277796|Device|Heat pack conduction-heat therapy|Hand warmer heat pack with reliable (and monitored) temperature (50-52 degrees Celsius) will be applied to lesion borders for 3 minutes (fractionated to 90 second intervals or less) every day, for 7 consecutive days.
16214889|NCT01277783|Device|Endocardial Left Ventricular pacing|Subjects receive an endocardial LV lead placement via superior approach using Medtronic Model 3830 lead and Medtronic Model 6227ATS deflectable delivery catheter and Medtronic Model 6248HS, 6248JL, or 6248JS delivery catheter, using trans esophageal echo (TEE) or intra-cardiac echo (ICE) to guide the procedure.
16214890|NCT01277770|Drug|Steroid-Free Maintenance Immunosuppression|10 year follow-up of steroid-free maintenance immunosuppression
16214891|NCT01277770|Other|Infection After Kidney Transplantation|A cross-sectional study of infection after kidney transplantation (with emphasis on infection in steroid-free recipients).
16214892|NCT01277770|Drug|Evaluation of the DGF nomogram in Thymoglobulin|An evaluation of the DGF nomogram in Thymoglobulin treated recipients at the University of Minnesota
16214893|NCT01277757|Drug|Akt Inhibitor MK2206|Given orally (PO) weekly, starting (dose 0) at 200 mg
16214894|NCT01277757|Other|Laboratory Biomarker Analysis|Correlative studies
16214895|NCT01277757|Other|Pharmacological Study|Correlative studies
16214896|NCT01277744|Procedure|Hyperthermic Peritoneal Perfusion (HIPEC)|HIPEC, technique for combining hyperthermia and chemotherapeutic agents delivered intraoperatively to the peritoneal and retroperitoneal surface via a recirculating perfusion circuit, performed after cytoreductive surgery and lysis of adhesions.
16214897|NCT01277744|Drug|Cisplatin|100 mg/M2 per perfusion catheter. The perfusion is continued for 90 minutes after adding the cisplatin.
16214898|NCT01277731|Drug|Methylprednisolone|Run-in period: dexamethasone 10-20mg q day iv during chemotherapy Treatment period: methylprednisolone 60-125mg iv during chemotherapy
16214899|NCT01277718|Drug|Cobimetinib|One 20-mg tablet of cobimetinib will be administered orally with 240 mL room temperature water after at least an 8-hour fast or approximately 30 minutes after starting the standardized FDA high-fat meal.
16214900|NCT01277718|Drug|Rabeprazole|Rabeprazole 20 mg will be administered orally once daily for 4 days starting on Day -4 and on Day 1 of the treatment period.
16214901|NCT01277705|Biological|GSK Biologicals' reduced antigen diphtheria and tetanus toxoids and acellular pertussis- inactivated poliovirus vaccine|Intramuscular, single
16214902|NCT01277705|Biological|Boostrix™|Intramuscular, single dose
16214903|NCT01277705|Biological|GSK Biologicals' IPV vaccine|Intramuscular, single dose
16214904|NCT01277705|Biological|Revaxis®|Intramuscular, single dose
16214905|NCT01277692|Drug|GSK2336805 10mg|single dose once daily
16214906|NCT01277692|Drug|GSK2336805 30mg|single dose once daily
16214907|NCT01277692|Drug|GSK2236805 100mg|single dose once daily
16214908|NCT01277692|Drug|GSK2236805 200mg|single dose once daily
16214909|NCT01277692|Drug|GSK2236805 10mg|repeat dose once daily for 7 days
16214910|NCT01277692|Drug|GSK2236805 dose to be determined up to 100mg|repeat dose once daily for 7 days
16214911|NCT01277692|Drug|GSK2236805 5mg|single dose in HCV infected patients
16214912|NCT01277692|Drug|GSK2236805 30mg|single dose in HCV infected patients
16214913|NCT01277692|Drug|GSK2236805 100mg|single dose in HCV infected patients
16214914|NCT01277679|Procedure|MRI|MRI of lungs to measure lung water content before and after passive leg raising (PLR)
16214915|NCT01277666|Drug|GSK1605786A|500 mg twice daily, administered orally for 12 weeks
16214916|NCT01277666|Drug|GSK1605786A|500 mg once daily, administered orally for 12 weeks
16214917|NCT01277666|Drug|Placebo|Placebo capsules, administered orally for 12 weeks
16214918|NCT01277653|Device|tumor maker interval shortly|tumor maker interval every 3 month
16214919|NCT01277640|Drug|dapivirine|"dosage form: gel 0.05%
~dosage: 2.5g
~frequency: once daily
~duration: 7 days"
16214921|NCT01277640|Drug|universal placebo|"dosage form: gel, HEC-based
~dosage: 2.5g
~frequency: once daily
~duration: 7 days"
16214922|NCT01277627|Drug|Nevirapine|nevirapine: 400 mg a day.
16214923|NCT01277627|Drug|efavirenz, protease inhibitors|efavirenz: 600 mg a day
16214924|NCT01277614|Behavioral|Therapeutic lifestyle|This is a 6-month intervention in which participants with 2r more MS components are randomly assigned to intervention or control group. Intervention comprise individual diet counseling, an exercise plan and monthly lifestyle workshops. Controls receive printed material on healthy eating and lifestyle modification.
16214925|NCT01277601|Drug|TDF|TDF 300 mg tablets administered orally once daily
16214926|NCT01277601|Drug|Peg-IFN|Peg-IFN 180 µg administered via subcutaneous injection once weekly
16214927|NCT01277575|Device|rtACS stimulation (Verum condition)|Repetitive, transorbital alternating current stimulation (rtACS) is applied with multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse is below 1000 microA. Current intensity is individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation
16214928|NCT01277575|Device|placebo condition|A clicking sound is presented and the same electrode montage set-up is used during rtASC- and Placebo-stimulation, except that placebo patients received no current (stimulator turned off).
16214929|NCT01277549|Device|Mononuclear cell collection.|Each donor will undergo one apheresis procedure to collect mononuclear cells from their peripheral blood.
16214930|NCT01277523|Drug|tiotropium high dose|2 actuations once daily
16214931|NCT01277523|Drug|placebo|2 actuations once daily
16214932|NCT01277523|Drug|tiotropium low dose|2 actuations once daily
16214933|NCT01277510|Drug|cinacalcet capsule|Cinacalcet was prepared for oral administration as both capsules for sprinkling and film coated tablets for swallowing.
16214934|NCT01277510|Drug|placebo|Placebo tablets and capsules for sprinkling identical to active treatment.
16214935|NCT01277510|Drug|Standard of Care|All participants, regardless of treatment assignment, will receive standard of care with vitamin D sterols (calcitriol and its analogs), as prescribed by the treating physician.
16214936|NCT01277497|Drug|Sevelamer carbonate|Sevelamer carbonate 1,600 mg three times daily with meals
16214937|NCT01277497|Drug|Calcium acetate|Calcium acetate 1,334 mg three times daily with meals for 12 weeks
16214938|NCT01277484|Drug|Decitabine|"1. Dose finding study (cycle 1-cycle4)
~Indicated dose for 5 consecutive days every 28 days
~Cohort 1: 5mg/m2 of decitabine
~Cohort 2 and 3:Dose escalation up to 15mg/m2 using a mechanism-based pharmacokinetic / pharmacodynamic model"
16214939|NCT01277471|Behavioral|Meal frequency (6 meals vs. 2 meals/day)|6 meals/day for 12 weeks followed by 2 meals/day for 12 weeks at the same caloric restriction (-500 kcal/day)
16214940|NCT01277471|Behavioral|6 meals/day followed by 2 meals/day|2 meals/day for the first 12 weeks followed by 6 meals/day for additional 12 weeks at the same caloric restriction (-500 kcal/day)
16214941|NCT01277445|Dietary Supplement|Prebiotic|Inulin-fructan 15mg/day for 28days
16214942|NCT01277445|Dietary Supplement|Prebiotic|Daily consumption of 15g inulin-fructan for 28 days
16214943|NCT01277432|Other|Psychiatrist Interview|"Patients will receive a face-to-face interview by a trained clinician or psychiatrist using the following instruments:
~MINI
~SSI-28 (somatization)"
16214944|NCT01277432|Other|Depression screening - control|"All study participants will undergo;
~a comprehensive diabetes assessment by completing a full set of questionnaires and clinical assessments, using the JADE e-portal
~a detailed psychological and behavioral assessments using validated questionnaires
~several specialist questionnaires on depression, self care and quality of life"
16214945|NCT01277406|Drug|4SC-201(Resminostat)|oral administration
16214946|NCT01277406|Drug|FOLFIRI|i.v. administration
16214947|NCT01277367|Behavioral|Discovery Vitality base program|The existing Discovery Vitality health promotion base program, which offers points for various levels of physical activity.
16214948|NCT01277367|Behavioral|Communication|Participants will be sent regular communications by Discovery Vitality -equivalent to the level of communications in the other incentive groups - which will provide information and tips about ways of accumulating Vitality points on the existing programme (concerning fitness-related activities, in particular).
16214949|NCT01277367|Behavioral|Charitable Incentive|Members will be asked to nominate a charity, from a selection of charities, which will benefit financially (Discovery Vitality will make a direct payment to a nominated charity) based on their (member's) level of participation in points-earning physical activity. Individuals will receive one of four possible payouts, corresponding to their level of engagement, for their selected charity (amounts given below). In addition, members will be sent regular updates of activities by their nominated charities (This will be operationalised and facilitated by Vitality- and as such, no direct mailing from nominated charity will take place, to maintain confidentiality.)
16214950|NCT01277367|Behavioral|Prize Draw Incentive|Members will be entered into a prize draw for a monthly cash-prize if they achieve physical activity targets. Four lottery payouts, corresponding to their levels of engagement, will be made on a monthly basis. All members will be sent information regarding the winnings of those that are drawn (unlinked to personal identifiers, but to motivate).
16214951|NCT01277367|Behavioral|Direct Payment|Members will receive a direct payment (in the form of gift voucher) of one of four possible amounts depending on the level of participation in fitness-related activities equivalent in expected value to the payouts in arms 3 and 4.
16214952|NCT01277367|Behavioral|Free Choice|Members will be asked to choose one of the three aforementioned incentive options on enrollment to the study.
16214953|NCT01277354|Behavioral|Cognitive Processing Therapy|"CPT utilizes a combination of a) exposure therapy aimed at extinguishing fear and distress induced by memories and external cues associated with the trauma, and b) cognitive behavioral techniques that address faulty thinking patterns developed to promote a sense of control over possible future traumas, but that instead perpetuate PTSD symptoms. In CPT, exposure to the traumatic memory occurs through writing and reading for periods of time determined by the client and is confined to the week of the 4th and 5th sessions. These sessions are otherwise used to identify stuck-points, i.e., distorted interpretations regarding the trauma and unrealistic beliefs regarding self and others."
16214954|NCT01277354|Behavioral|Waitlist Placebo|Behavioral ratings are conducted by a blind rater.
16217367|NCT01258855|Biological|Ziv-Aflibercept|Given IV
16214955|NCT01277341|Drug|Bepotastine Besilate Nasal Spray 2% Twice a day|nasal spray
16214956|NCT01277341|Drug|Bepotastine Besilate Nasal Spray 3% Twice a day|nasal spray
16214957|NCT01277341|Drug|Bepotastine Besilate Nasal Spray 4% Twice a day|nasal spray
16214958|NCT01277341|Drug|Placebo Nasal Spray|nasal spray
16214959|NCT01277315|Drug|Anakinra|Open Safety and Tolerability study to evaluate a subcutaneous application 100 mg of Anakinra in combination with Riluzol in Amyotrophic Lateral Sclerosis.
16214960|NCT01277302|Drug|Ranibizumab|Liquid ranibizumab (10 mg/ml) was supplied in a sterile solution in single-use vials.
16214961|NCT01277289|Drug|Dexamethasone|500 mg/20 ml encapsulated in erythrocytes, every month for 12 months
16214962|NCT01277276|Device|Diffuse optical spectroscopy and Near infrared spectroscopy|Diffuse optical spectroscopy and Near infrared spectroscopy are non-invasive methods measure tissue hemodynamics in real time, direct quantitative information and insights treatment-associated toxicity.
16214963|NCT01277263|Device|Diffuse Optical Spectroscopy Imaging|Monitoring Breast Cancer during chemo therapy
16214964|NCT01277250|Behavioral|Web-based smoking cessation program|"Web-based smoking cessation program that includes a transition coach to hospitalized patients who will assist them in quitting as they are discharged from the hospital. Intervention arm participants will have access to a tailored web-based intervention that will include e-messages and activities that are tailored to their recent hospital stay."
16214965|NCT01277237|Drug|Omacor|Active comparator: omacor 4g/day
16214966|NCT01277237|Drug|lactose tablet|placebo: lactose tablet 4g/day
16214967|NCT01277224|Behavioral|Movi2 Program|In the Movi2 program we will perform a recreational physical activity intervention during one year that include standardized recreative and non competitive activities conducted by sports instructors. It consisted of two 90-min after school sessions per week on school days and one 150-minute session on Saturday morning.
16214968|NCT01277211|Drug|ENG 120 µg + EE 15 µg intravaginal ring|13 cycles of ENG-EE (NuvaRing) vaginal ring use. Each cycle 28 days, with a 21-day active treatment period followed by 7-day ring-free period. One ring per cycle, each ring containing 11.7 mg ENG and 2.7 mg EE, and releasing on average 120 mcg/day of ENG and 15 mcg/day of EE.
16214969|NCT01277211|Drug|DRSP 3 mg + EE 30 µg|13 cycles of DRSP-EE tablet use. Each cycle 28 days, with a 21-day active treatment period followed by a 7-day tablet-free period. Participants received total of 21 tablets per cycle, each tablet contained 3 mg DRSP and 30 μg EE.
16214970|NCT01277185|Dietary Supplement|Low Calcium Diet|The basal diet will contain 600 mg of Ca per day and constant sufficient amounts of all other nutrients. Additional Ca will be given unfortified beverages served three times per day. Teens will be randomized to a lower (600-1200 mg/d)level of calcium in the first camp followed by the opposite (higher calcium diet)regime in the second camp.
16214971|NCT01277185|Dietary Supplement|High Calcium Diet|The basal diet will contain 600 mg of Ca per day and constant sufficient amounts of all other nutrients. Additional Ca will be given unfortified beverages served three times per day. Teens will be randomized to a higher (1100-2300mg/d)level of calcium in the first camp followed by the opposite (lower calcium diet)regime in the second camp.
16214972|NCT01277172|Biological|Rituximab|375 mg/m2 IV every 2 weeks for 6 cycles
16214973|NCT01277172|Biological|Rituximab|375 mg/m2 IV every 2 weeks for 6 cycles
16214974|NCT01277172|Biological|Rituximab|375 mg/m2 IV every 2 weeks for 6 cycles
16214975|NCT01277172|Biological|Rituximab|375 mg/m2 IV every 14 days for 6 cycles
16214976|NCT01277159|Drug|A. Control Nerve Block. IV Dexamethasone (4 mg).|A. Control Nerve Block. IV Dexamethasone (4 mg).
16214977|NCT01277159|Drug|B. Nerve Block with Dexamethasone (4 mg). IV saline.|B. Nerve Block with Dexamethasone (4 mg). IV saline.
16214978|NCT01277159|Drug|C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)|C. Control Nerve Block. IV Dexamethasone (4 mg). IV Buprenorphine (0.3 mg)
16214979|NCT01277159|Drug|D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).|D. Nerve Block with Buprenorphine (0.3 mg). IV Dexamethasone (4 mg).
16214980|NCT01277159|Drug|E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg).|E. Nerve Block with Dexamethasone (4 mg) / block Buprenorphine (0.3 mg). IV saline.
16214981|NCT01277146|Drug|OMP-59R5|IV infusion
16214982|NCT01277107|Drug|Zaleplon AP formulation|Gastric retentive dual release Zaleplon
16214983|NCT01277107|Drug|Placebo capsule|Identical placebo capsule
16214984|NCT01277094|Drug|Placebo|Oral daily doses for 12 weeks
16214985|NCT01277094|Drug|RO5093151|Oral daily doses for 12 weeks
16214986|NCT01277081|Drug|Paracetamol hot drink|Hot drink containing paracetamol
16214987|NCT01277081|Drug|Paracetamol tablets|Paracetamol tablets
16214988|NCT01277068|Procedure|Surgical and medical procedures|this study want to compare the differential effect of the 3 bariatric surgery procedures on the production rates of the intestinal TRL: the adjustable gastric banding the sleeve gastrectomy the gastric bypass
16214989|NCT01277042|Biological|GSK580299 (CervarixTM)|3-dose schedule intramuscularly vaccination (Months 0, 1 and 6)
16214990|NCT01277042|Biological|Engerix-BTM|3-dose schedule intramuscularly vaccination (Months 0, 1 and 6)
16214991|NCT01277029|Other|No drug|Psychopathology, personality traits of patients with lower urinary tract symptoms
16214992|NCT01277016|Drug|BMDex|"BMDex:
~cycles 1 and 2 = MDex with bortezomib (B) at 1.3 mg/m2 i.v. on days 1, 4, 8 and 11 of a 28 day cycle, cycles 3 - 8 = MDex with bortezomib at 1.3 mg/m2 i.v. on days 1, 8, 15 and 22 of a 35 day cycle."
16214993|NCT01277003|Device|Aculife Magnetic Wave Therapist|two therapeutic points, each for 15 minutes
16214994|NCT01277003|Device|TENS|tow therapeutic points, each for 15 minutes
16214995|NCT01276990|Drug|BI 224436|Oral drinking solution
16214996|NCT01276990|Drug|BI 224436|Oral drinking solution
16214997|NCT01276990|Drug|BI 224436|Oral drinking solution
16214998|NCT01276990|Drug|BI 224436|Oral drinking solution
16214999|NCT01276990|Drug|BI 224436|Oral drinking solution
16215000|NCT01276990|Drug|BI 224436|Oral drinking solution
16215001|NCT01276990|Drug|BI 224436|Oral drinking solution
16215002|NCT01276990|Drug|BI 224436|Oral drinking solution
16215003|NCT01276990|Drug|BI 224436|Oral drinking solution
16215004|NCT01276990|Drug|Placebo|Oral drinking solution
16218137|NCT01252758|Drug|albuterol sufate DPI (TBS-7) dose 3|
16215005|NCT01276977|Drug|Zolmitriptan 5 mg Nasal Spray|Patients will treat 2 migraine attacks with zolmitriptan 5 mg nasal spray and 2 migraine attacks with eletriptan.
16215006|NCT01276977|Drug|Eletriptan 40 mg tablet|Patients will treat 2 migraine attacks with Eletriptan and 2 migraine attacks with zolmitriptan 5 mg nasal spray
16215007|NCT01276951|Dietary Supplement|Delivery and return of chocolate|At baseline and then every 2 weeks, each participant will receive different grams of chocolate, according to the group to which he is assigned.
16215008|NCT01276951|Procedure|Determination of blood pressure|Blood pressure will be determined at study entry, ninth and eighteenth week taking into account the protocols established in 2007 by the European Society of Cardiology and Hypertension. Because blood pressure has variations throughout the day and that measuring ambulatory health institutions can generate emotional changes that induce changes in this clinical setting, which for purposes of this study is the main outcome variable, there will be 24-hour monitoring of blood pressure at the beginning and end of the study.
16215009|NCT01276951|Procedure|Anthropometric Measurements|The study will be determined the body mass index (BMI) by the ratio of weight in kilograms over height in meters squared, for which anthropometric measurement will be made at first, ninth and the eighteenth week as follows: The weight will be taken with an electronic balance of 0.05 g sensitivity standing capacity of 150 kg. We will be rated based on BMI cut points given by WHO-PAHO (1993) and adopted by the Ministry of Health of Colombia (2000).
16215010|NCT01276951|Procedure|Food Anamnesis|With the aim of learning about the eating habits, it will be made based on a food intake recall the last 24 hours, taking into account that is not preceded by a special food day (sundays, holidays, celebrations). For more accurately calculate nutrient ingested food, modules will be used.
16215011|NCT01276951|Procedure|Samples: serological tests and culture of mononuclear cells|At admission and at the end of the study will be obtained after 12 hours of fasting, 8 mL of blood in a dry tube without anticoagulant and 30 mL of blood in heparin tubes, properly labeled with the code assigned to the participant. The sample will be used to determine the complete lipid profile (triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol and VLDL cholesterol), State of oxidation of low density lipoprotein (oxLDL) and mononuclear cell culture. The remaining serum was kept at -20°C for use if is required repeat any study.
16215012|NCT01276951|Procedure|Analysis of cytokine production|We will be used the supernatant of mononuclears cell culture to quantify the production of interleukin one beta, interleukin two, tumor necrosis factor alpha by ELISA with commercially available kits for this purpose.
16215013|NCT01276938|Radiation|21 Gy radiation|21 Gy radiation using electrons produced with mobile linear accelerator (energies ranging from 4 to 10 MeV)
16215014|NCT01276938|Radiation|18 Gy radiation|18 Gy radiation using electrons produced with mobile linear accelerator (energies ranging from 4 to 10 MeV)
16215015|NCT01276925|Drug|Ropivacaine|7,5 mg/ml. 10 ml for the femoral nerve, 10 ml for the anterior division of the obturator nerve, 5 ml for the lateral femoral cutaneous nerve.
16215016|NCT01276925|Drug|Ropivacaine|7,5 mg/ml. 10 ml for the anterior division of the obturator nerve, 5 ml for the lateral femoral cutaneous nerve.
16215017|NCT01276925|Device|Ultrasound|All nerve blockades will be performed with ultrasound guidance.
16215018|NCT01276925|Procedure|Peripheral nerve blockade|All patients will receive injections around the three nerves before surgery.
16215019|NCT01276925|Drug|Saline|Isotonic. 10 ml for the femoral nerve.
16215020|NCT01276925|Procedure|Total hip arthroplasty|All patients undergoes total hip arthroplasty.
16215021|NCT01276925|Drug|Bupivacaine|5 mg/ml. 3 ml for spinal anaesthesia.
16215022|NCT01276912|Drug|Insulin glargine|Insulin glargine therapy with a dosage adjusted to get FBG ≤ 5.3mmol / L as the goal, accompanied with a lifestyle counseling.
16215023|NCT01276912|Behavioral|Lifestyle counseling|To give lifestyle guidance, specifically including low fat, low saturated fatty acids, rich in dietary fiber, salt restriction, limit alcohol diet plan to reduce the 5% to 10% of body weight, and to ensure a regular moderate physical activity at least 150 minutes per week.
16215024|NCT01276899|Procedure|Needle core biopsies|"No investigational products will be administered to subjects as part of this translational research study.
~A taxane-based regimen will be administered as per the standard of care at each treating institution. Tissue samples from primary tumors will be collected and banked before the start of chemotherapy, after chemotherapy and at the time of surgery. Additionally, blood samples will be drawn before treatment initiation (baseline) and at different time points during treatment and stored in the tissue biobank."
16215025|NCT01276899|Procedure|Needle core biopsies of metastatic lesion|"No investigational products will be administered to subjects as part of this translational research study.
~Chemotherapy will be administered as per the standard of care at each treating institution. Tissue samples from metastatic tumors lesions will be collected and banked before the start of chemotherapy and at the time of progression. Additionally, blood samples will be drawn before treatment initiation (baseline) and at different time points during treatment and stored in the tissue biobank."
16215026|NCT01276886|Drug|antibiotic|
16215027|NCT01276886|Procedure|Colonic resection with or without stoma|
16215028|NCT01276873|Device|Tracheal aspiration close system|use of closed system in comparision to open system to tracheal aspiration of nweborns, analyzing pain and climical variations associated.
16215029|NCT01276860|Device|Psychomotor Vigilance Testing|The purpose of this study is to examine the use of psychomotor vigilance testing (PVT) as a tool in the diagnosis and prediction of pediatric obstructive sleep apnea. PVT simply involves responding to a light by pressing a button on a small handheld device. It is a simple measure of reaction time.
16215030|NCT01276847|Drug|Ustekinumab|Ustekinumab 45 mg per dose, administered subcutaneously for participants weighing ≤ 100 kg, and ustekinumab 90 mg per dose administered subcutaneously for participants weighing > 100 kg on Day 1, and Weeks 4 and 16
16215031|NCT01276847|Drug|Etanercept|Etanercept 50 mg twice weekly by self-administered subcutaneous injection for 12 weeks, then once weekly for 4 weeks
16215032|NCT01276834|Drug|everolimus|comparison of everolimus-based and CNI-based immunosuppression
16215033|NCT01276821|Drug|L-Epinephrine and Normal Saline (0.9%)|1.5ml of 1:1,000 L-Epinephrine and 4 ml of 0.9% Normal Saline
16215034|NCT01276821|Drug|L-Epinephrine and Hypertonic Saline (3%)|1.5ml of 1:1,000 L-Epinephrine and 4 ml of 3% Hypertonic Saline
16215035|NCT01276808|Procedure|Magnetic navigation PCI|Magnetically navigated angioplasty wire technique
16218138|NCT01252758|Other|Placebo|
16215036|NCT01276808|Procedure|Conventional PCI|Conventional manual angioplasty wire percutaneous coronary intervention
16215037|NCT01276795|Dietary Supplement|Oral Nutrition Support|The patients will sip the oral nutrition support (in the form of a drink) over the course of 4 hours within each 6 hour study. Each patient will be studied once before surgery and once after surgery.
16215038|NCT01276782|Drug|Levothyroxine|It is FDA approved drug for thyroid disease
16215039|NCT01276769|Drug|Paclitaxel plus carboplatin|"Paclitaxel 175 mg/m2 D1 i.v., carboplatin AUC=5 D2 i.v.
~1 cycle = 21days 2-6cycles"
16215040|NCT01276769|Drug|Paclitaxel and epirubicin|"Paclitaxel 175 mg/m2 D3 i.v.,Epirubicin 75mg/m2 D1，2 i.v.
~1 cycle = 21days
~2-6cycles"
16215041|NCT01276756|Drug|Pegylated interferon alfa-2a|Pegylated interferon 160ug once weekly 48 weeks
16215042|NCT01276756|Drug|Nitazoxanide|Nitazoxanide 500mg twice daily 4 weeks lead-in followed by triple therapy 48 weeks
16215043|NCT01276756|Drug|Ribavirin|Ribavirin (> 75kg:1200 mg, <75kg:1000mg daily)48 weeks
16215044|NCT01276730|Drug|Interferon, Retinoic Acid and radiation|Interferon-α2b will be administered 3 times a week for four weeks at a dose of 3 x 106 IU subcutaneously concomitant with radiotherapy. The first dose will be administered on the day the subject starts radiotherapy; 13-cis-retinoic acid will be administered orally at a dose of 40 mg/day for 1 month starting from day 1 of radiotherapy; a total of 40 to 45 Gy whole pelvis irradiation will be delivered in conventional fractions to both the study group and the control group. Additional parametrial dosages will be delivered to complete 55 Gy. This will be followed by two intracavitary applications of approximately 40-50 Gy, depending on the volume.
16215045|NCT01276730|Drug|Cisplatin and radiation|Weekly cisplatin will be administered concurrent with external beam radiation at a dose of 40mg/m2/week for 5 weeks; a total of 40 to 45 Gy whole pelvis irradiation will be delivered in conventional fractions. Additional parametrial dosages will be delivered to complete 55 Gy. This will be followed by two intracavitary applications of approximately 40-50 Gy, depending on the volume.
16215046|NCT01276717|Drug|Drug: Carfilzomib|Carfilzomib 30 minutes infusion daily for days 1, 2, 8, 9, 15, 16, Every 28 days. A maximum of 13 cycles will be administered.
16215047|NCT01276717|Drug|Vorinostat|Vorinostat by mouth twice daily on days 1, 2, 3, 8, 9, 10, 15, 16 and 17. Maximum 13 cycles.
16215048|NCT01276704|Drug|Placebo|The placebo contains same filler materials as commercially available Brevail® but without active SDG.
16215049|NCT01276704|Drug|secoisolariciresinol|1 capsule daily of secoisolariciresinol diglycoside (SDG)50mg
16215050|NCT01276691|Drug|81 mg enteric coated aspirin|81 mg enteric coated aspirin will be provided both as an acute dosage immediately prior to firefighting (1 hour pre-activity) and as a 14 day dosage prior to firefighting
16215051|NCT01276665|Procedure|restrictive intraoperative fluid substitution|to analyze the impact of a restrictive volume regimen using advanced balanced electrolyte solution (which is by far more restrictive than the published data) combined with noradrenaline. We include only radical cystectomy and so nearly exclude surgical bias
16215052|NCT01276665|Procedure|assessment of the pelvic venous pressure|A 20 G catheter will be introduced into a small collateral vein of the internal iliacal vein to monitor pelvic venous pressure
16215053|NCT01276652|Behavioral|Environmental modification|Environmental modification consists of nursing-related efforts to optimize daytime light exposure, to minimize nighttime light and noise exposure, and to batch nursing care at night.
16215054|NCT01276639|Drug|CP-690,550|10 mg oral BID, Continuous treatment for 52 Weeks
16215055|NCT01276639|Drug|CP-690,550|5 mg oral BID, Continuous treatment for 52 Weeks
16215056|NCT01276639|Drug|Placebo/CP-690,550|0 mg oral BID, Continuous treatment for 16 Weeks; 10 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)
16215057|NCT01276639|Drug|Placebo/CP-690,550|0 mg oral BID, Continuous treatment for 16 Weeks; 5 mg oral BID, Continuous Treatment for 36 Weeks (after completion of 16 Weeks of Placebo)
16215058|NCT01276626|Dietary Supplement|Bifidobacterium longum|Powder containing Bifidobacterium longum in maltodextrin.
16215059|NCT01276626|Other|Maltodextrin|Powder containing only maltodextrin
16215060|NCT01276613|Drug|Gemcitabine|Gemcitabine administered by the anesthesiologist as a dose of 1,000mg/m2 at a fixed dose rate of 10mg/m2/min.
16215061|NCT01276613|Drug|Losartan|50 mg by mouth daily for one week and 50 to 100 mg of Losartan by mouth daily for at least 1 week and at most 3 weeks prior to surgical resection.
16215062|NCT01276600|Drug|Emtricitabine/tenofovir|200mg of emtricitabine 300mg of tenofovir
16215063|NCT01276587|Drug|Vitamin D3|Oral vitamin D3 100,000 IU administered monthly for six months in children and adolescents with sickle cell disease
16215064|NCT01276561|Procedure|Single Incision Splenectomy|Patients will undergo laparoscopic splenectomy through a single incision
16215065|NCT01276561|Procedure|Laparoscopic Splenectomy|Patients will undergo laparoscopic splenectomy with 4 ports, placement is surgeon dependent
16215066|NCT01276548|Drug|Genexol®-PM 260mg/m2 plus Carboplatin 5 AUC|
16215067|NCT01276548|Drug|Genexol® 175mg/m2 plus Carboplatin 5 AUC|
16215068|NCT01276535|Device|Erchonia MLS + Erchonia THL|"The Erchonia® MLS is administered weekly for 6 continuous weeks at the test site by the study investigator.
~The Erchonia THL is administered twice daily for 6 continuous weeks (42 days) at home by the subject.
~Administration of the MLS and the THL occur simultaneously over the 6-week administration phase.
~The intent is to evaluate the effectiveness of Erchonia MLS & Erchonia THL when administered together, and not to compare Erchonia MLS vs. Erchonia THL"
16215069|NCT01276522|Drug|Canakinumab|Monthly subcutaneous injection with 150mg Canakinumab for 6 months
16215070|NCT01276509|Drug|PF-00547659 SC injection|Placebo delivered SC, 3 doses separated by 4 weeks
16215071|NCT01276509|Drug|PF-00547659 SC injection|Drug dose level 1 delivered SC, 3 doses separated by 4 weeks
16215072|NCT01276509|Drug|PF-00547659 SC injection|Drug dose level 2 delivered SC, 3 doses separated by 4 weeks
16215073|NCT01276509|Drug|PF-00547659 SC injection|Drug dose level 3 delivered SC, 3 doses separated by 4 weeks
16215074|NCT01276496|Drug|Cilengitide|Given IV
16215075|NCT01276496|Other|Laboratory Biomarker Analysis|Correlative studies
16215076|NCT01276496|Drug|Paclitaxel|Given IV
16215077|NCT01276496|Other|Pharmacological Study|Correlative studies
16215272|NCT01275105|Drug|Oxymetazoline HCl 0.025%|one drop in each eye at designated visits
16218139|NCT01252758|Drug|Albuterol|
16215078|NCT01276457|Drug|Everolimus 0.25 and 0.75 mg tablets|The dose of everolimus for each patient was adjusted to achieve the target everolimus blood level range. Everolimus blood trough level was measured 5 days after any dose adjustment to verify that the blood level was within the desired target level range.
16215079|NCT01276457|Drug|Cyclosporine very low dose (150-300 ng/mL) microemulsion|The dose of cyclosporine for each patient was adjusted to achieve the target cyclosporine blood level. Cyclosporine dose adjustments were based on drug blood level determined from whole blood samples taken 2 hours (± 10 min) after the morning dose.
16215080|NCT01276457|Drug|Cyclosporine low dose (350-500 ng/mL) microemulsion|The dose of cyclosporine for each patient was adjusted to achieve the target cyclosporine blood level. Cyclosporine dose adjustments were based on drug blood level determined from whole blood samples taken 2 hours (± 10 min) after the morning dose.
16215081|NCT01276444|Device|Swan-Ganz catheter|the data s=derived from PAC included pulmonary artery occlusion pressure etc
16215082|NCT01276444|Device|transpulmonary thermodilution + central venous saturation|Described in details above
16215083|NCT01276431|Drug|Buprenorphine transdermal patch|
16215084|NCT01276418|Device|CO2 laser|Ablation and coagulation of soft tissue
16215085|NCT01276379|Drug|FOLFIRI (m)|"FOLFIRI (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
~Irinotecan 180 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
~l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2), in infusion i.v., 120 minutes, on day 1.
~One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
~5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours."
16215086|NCT01276379|Drug|FOLFOX-6 (m)|"FOLFOX6 (m) chemotherapy will be administered on day 1 of each 14-days-cycle. The administered doses will be:
~Oxaliplatin 85 mg/m2 in infusion i.v., 120 minutes, on day 1 of each cycle.
~l-Leucovorin 200 mg/m2 (or d,l-leucovorin 400 mg/m2) in infusion i.v., 120 minutes, on day 1.
~One bolus i.v. (2-4 minutes) of 400 mg/m2 of 5-FU on day 1.
~5-FU in continuous infusion (2400 mg/m2) administered through an ambulatory pump during 46-48 hours."
16215087|NCT01276379|Drug|Cetuximab|- 500 mg/m2 i.v. Every 2 weeks.
16215088|NCT01276366|Other|breast feeding|Newborns who are assigned to group one, receive breastfeeding during the blood sample and thereby have skin-skin contact between mother and child.
16215089|NCT01276366|Other|supplemental breast milk|In group two, the newborns receive supplemental breast milk, lying in the arms of a nurse during the heel lance.
16215090|NCT01276366|Other|sucrose|In the third group, newborns receive sucrose 1ml 24% two minutes before procedure, followed by non-nutritive sucking. During the procedure the newborn lies in his cot.
16215091|NCT01276353|Drug|E2020|Patients will take study medication orally, once daily, for 2 weeks according to a double-dummy design in the double blind phase: 23 mg donepezil sustained release (SR) concurrently with placebo identical in appearance to the 10 mg donepezil immediate release (IR) formulation
16215092|NCT01276353|Drug|E2020|10 mg donepezil immediate release (IR) concurrently with placebo identical in appearance to the 23 mg donepezil sustained release (SR) formulation. All patients who complete the double blind phase will take 23 mg donepezil sustained release (SR) orally, once daily, for 52 weeks in the Open-label Extension phase.
16215093|NCT01276340|Device|KEAT stimulator|electrical stimulation with KEAT stimulator : 4 times per week during 2 months
16215094|NCT01276327|Drug|Linagliptin + Pioglitazone|Medium doses, oral administration
16215095|NCT01276327|Drug|Linagliptin + Pioglitazone|Medium doses, oral administration
16215096|NCT01276327|Drug|Linagliptin/Pioglitazone|Medium dose oral administration
16215097|NCT01276327|Drug|Linagliptin/Pioglitazone|Medium dose oral administration
16215098|NCT01276314|Drug|anti- TNF-a|25mg BIW, SC
16215099|NCT01276314|Drug|Prednisolone|1-1.5 mg / kg / day
16215100|NCT01276301|Drug|Verapamil|single dose verapamil
16215101|NCT01276301|Drug|BI 10773|single dose BI 10773
16215102|NCT01276301|Drug|BI 10773|single dose BI 10773
16215103|NCT01276288|Drug|BI 10773|multiple oral doses
16215104|NCT01276288|Drug|hydrochlorothiazide|multiple oral doses
16215105|NCT01276288|Drug|torasemide|multiple oral doses
16215106|NCT01276288|Drug|BI 10773|multiple oral doses
16215107|NCT01276288|Drug|torasemide|multiple oral doses
16215108|NCT01276288|Drug|BI 10773|multiple oral doses
16215109|NCT01276288|Drug|hydrochlorothiazide|multiple oral doses
16215110|NCT01276275|Drug|Risk of selected safety events|First time users of ticagrelor, clopidogrel and prasugrel, respectively
16215111|NCT01276262|Drug|fostamatinib|Oral tablets, repeated doses for 21 days (2 x 50mg BID)
16215112|NCT01276262|Drug|Microgynon® 30 (Oral contraceptive)|Oral tablets, repeated doses
16215113|NCT01276262|Drug|Placebo|Oral tablets BID, repeated doses for 21 days
16215114|NCT01276249|Device|Fortevo Endograft|The Fortevo Endograft, Main Body and Iliac Lumen Delivery System are indicated for the endovascular treatments of patients with infrarenal abdominal aortic aneurysms or aortic-iliac aneurysms having suitable morphology for endovascular repair.
16215115|NCT01276236|Drug|Maraviroc|"FDA Recommended dosing will be used in this study. Subjects on an efavirenz or etravirine-based regimen will be dosed at 600 mg orally, twice per day, for 96 weeks.
~Subjects on a ritonavir-boosted protease inhibitor based regimen (except for tipranavir/ritonavir) will be dosed at 150 mg orally, twice per day, for 96 weeks.
~Subjects that are on regimens that do not include etravirine, efavirenz, or ritonavir will be dosed at 300mg orally, twice per day, for 96 weeks. These doses are based on the recommendations from the company based on drug-drug interactions."
16215116|NCT01276223|Drug|Difluprednate 0.05% ophthalmic emulsion|Topical ocular steroid
16215117|NCT01276223|Other|Difluprednate vehicle|Inactive ingredients used as Run-In and placebo comparator
16215118|NCT01276210|Drug|sorafenib tosylate|Given PO
16215119|NCT01276210|Radiation|stereotactic radiosurgery|Undergo stereotactic radiosurgery
16215120|NCT01276210|Other|laboratory biomarker analysis|Correlative studies
16215121|NCT01276197|Other|Story-Telling DVD|DVD will contain both informational and story-telling components.
16215122|NCT01276197|Other|Non-Storytelling DVD|DVD will contain only informational component.
16215273|NCT01275092|Device|CorPath robotic-assisted PCI|CorPath 200® robotic-assisted percutaneous coronary intervention
16218140|NCT01252758|Drug|Albuterol|
16215123|NCT01276184|Behavioral|SMS Text Message|Women in the SMS Text Message group that reschedule a vaccination visit will receive text message reminders one per day for each of the seven days prior to the rescheduled visit (or as many days as possible depending on when the rescheduled visit will take place - for example, if they call in and reschedule the visit to take place in 4 days, they will receive text messages for the 3 days prior to the rescheduled visit). Participants in both the Usual Care group and the SMS Text Message group will receive the standard reminder from the clinic for their re-scheduled appointment(s).
16215124|NCT01276171|Procedure|Ultrasound|Participants will place arterial line using ultrasound technique
16215125|NCT01276171|Procedure|Doppler|Participants will place arterial line using doppler technique
16215126|NCT01276171|Procedure|Palpation|Participants will place arterial line using Palpation technique
16215127|NCT01276158|Procedure|Ultrasound|Ultrasound used to place arterial line
16215128|NCT01276158|Procedure|Doppler|Doppler used to place arterial line
16215129|NCT01276119|Biological|CDP6038|100 mg/mL solution for injection Single infusion over 60 minutes
16215130|NCT01276119|Biological|CDP6038|100 mg/mL solution for injection Single infusion over 120 minutes
16215131|NCT01276119|Biological|CDP6038|100 mg/mL solution for injection Single sc injection
16215132|NCT01276119|Other|Placebo|0.9% sodium chloride for injection Single infusion over 60 minutes
16215133|NCT01276119|Other|Placebo|0.9% sodium chloride for injection Single infusion over 120 minutes
16215134|NCT01276119|Other|Placebo|0.9% sodium chloride for injection Single sc injection
16215135|NCT01276106|Drug|AC-201, 25mg|Capsule, 25mg BID
16215136|NCT01276106|Drug|AC-201, 50mg|Capsule, 50mg BID
16215137|NCT01276106|Drug|AC-201, 75mg|Capsule, 75mg BID
16215138|NCT01276106|Drug|Placebo|Placebo BID
16215139|NCT01276093|Procedure|PVI ablation|Pulmonary Vein Ablation using RF.
16215140|NCT01276093|Drug|Amiodarone|Amiodarone tablets
16215141|NCT01276080|Drug|Donepezil|10 mg tablets
16215142|NCT01276067|Drug|Donepezil|10 mg Tablet
16215143|NCT01276054|Radiation|technetium Tc 99m sulfur colloid|Given intradermally and periareolarly
16215144|NCT01276054|Drug|methylene blue|Given subcutaneously
16215145|NCT01276054|Drug|indocyanine green solution|Given subcutaneously
16215146|NCT01276054|Procedure|sentinel lymph node biopsy|Undergo sentinel lymph node biopsy
16215147|NCT01276054|Procedure|axillary lymph node biopsy|Undergo axillary lymph node biopsy
16215148|NCT01276054|Procedure|bioimpedance spectroscopy|Correlative studies
16215149|NCT01276054|Procedure|quality-of-life assessment|Ancillary studies
16215150|NCT01276054|Other|lymphedema management|Undergo axillary reverse mapping
16215151|NCT01276041|Drug|pertuzumab in combination with trastuzumab and paclitaxel|The regimen will consist of paclitaxel (80 mg/m2) weekly + trastuzumab every 3 weeks (8 mg/kg loading dose → 6 mg/kg every 3 weeks) + pertuzumab every 3 weeks (840 mg as a loading dose → 420 mg), all given intravenously (IV). Patients may be given trastuzumab weekly in lieu of every 3 weeks (4 mg/kg loading dose → 2 mg/kg every 3 weeks). Patients will be on treatment until progression of disease.
16215152|NCT01276028|Procedure|Acupuncture|"For the Acupuncture group: Women will be eligible to receive from 1 to 20 treatments over a six month period. These women will receive an initial evaluation by a acupuncturist and will be given a Traditional Chinese Medicine (TCM) diagnosis as well as a recommended treatment schedule which they can then negotiate.
~Women in the waitlist group will not receive any acupuncture for 6 months. At the end of the 6 month period the participants will be allowed to begin the acupuncture treatments."
16215153|NCT01276015|Drug|Botulinum Toxin Type A|BoNT-A (Dysport, Ipsen) ,into the medial gastrocnemius (MG) and LG muscles unilaterally on the affected spastic hemiplegic side; dose mean± SE, 283.3± 24.7 U.. The mean dose/kg injected was 14.4± 0.8, range from 8.5 to 20 U/kg, diluted in 2.5 ml saline. frequency: once.
16215154|NCT01276002|Procedure|pancreatic duct stenting|in case of a disrupted pancreatic duct, patients will undergo pancreatic duct stenting.
16215155|NCT01275989|Other|Ear acupuncture|
16215156|NCT01275976|Drug|C1-esterase inhibitor|C1-esterase inhibitor 200 U/kg infusion over 30 minutes, just before the start of the femur or pelvic fixation operation.
16215157|NCT01275976|Other|Saline 0.9%|Infusion, just before the start of the femur or pelvic fixation operation
16215158|NCT01275950|Behavioral|Health Education|"Implementing the intervention programme designed for creating awareness about harmful effect of tobacco (smoked and smokeless forms) and the current regulation to the shop-owners.
~Administering the questionnaire to objectively asses the impact of direct/ surrogate tobacco advertisements influencing student behavior and perception about tobacco and tobacco products.
~Implementing the intervention programme designed for creating awareness about harmful effect of tobacco (smoked and smokeless forms) and the current regulation to the students through interactive sessions with students in their respective educational institute."
16215159|NCT01275937|Drug|Esomeprazole|Esomeprazole 40 mg IV daily is given for three days. Thereafter, the patients receive 40 mg Esomeprazole orally daily for two months.
16215160|NCT01275937|Drug|esomeprazole|esomeprazole 160 mg/day continuous infusion is given for three days. Thereafter, the patients receive 40 mg nexium orally daily for two months.
16215161|NCT01275924|Device|Tightrope Syndesmosis Repair Kit|Tightrope Syndesmosis Repair Kit
16215162|NCT01275924|Device|Syndesmotic screw|Quadricortical syndesmotic screw
16215163|NCT01275911|Drug|Esmolol|Induction of anesthesia: 1mg/Kg; Maintenance during surgery: 5-15 mcg/kg/min
16215164|NCT01275911|Drug|Remifentanil|At the induction of anesthesia: 1mcg/Kg; Maintenance during surgery: 0.025-0.25mcg/kg/min
16215165|NCT01275885|Dietary Supplement|cholecalciferol (D3)|10µg (400 IU) orally daily for 10 weeks
16215166|NCT01275885|Dietary Supplement|cholecalciferol (D3)|30µg (1200 IU) orally daily for 10 weeks
16215167|NCT01275885|Dietary Supplement|cholecalciferol (D3)|40µg (1600 IU) orally daily for 10 weeks
16215168|NCT01275872|Other|Guided Imagery and Progressive Muscle Relaxation|4 supervised sessions per patient for 4 weeks additional to daily unsupervised sessions
16215169|NCT01275859|Drug|Letrozole, Lapatinib|Letrozole 2.5mg po qd+ Lapatinib 1500mg po qd for 18-21 wks
16215391|NCT01273987|Procedure|rONB|Neobladder posterior wall suspended with round ligament of uterus after radical cystectomy in female with bladder cancer
16215170|NCT01275846|Device|Health Guide using AHA heart failure protocols and content|Participants in the study will receive the use of the Intel Health Guide, a telehealth device, with AHA customized heart failure protocols, response algorithms and educational content. Participants interact with the Intel Health Guide device, receiving immediate feedback when transmitting vitals measures and health question responses to a site monitored by their nurse case managers. Nurse case managers review and address concerns raised in vitals and/or question responses through standard care protocols established by their institution. Nurse case managers strive to enhance the participants quality of life, support continuity of care, facilitate provision of services in the appropriate setting to promote positive health outcomes.
16215171|NCT01275833|Device|Cardiac resynchronization therapy-defibrillator|Device programming that modifies AV timing
16215172|NCT01275820|Dietary Supplement|Nutralin|Food product to be taken 15 minutes prior to each of the three main meals of the day.
16215173|NCT01275807|Device|acupuncture|10 sessions of acupuncture
16215174|NCT01275807|Other|self care|physical exercice, diet, self help groups, psychological support
16215175|NCT01275781|Drug|[14C]-AZD9742|1000 mg intravenous over 2 hours
16215176|NCT01275768|Procedure|Endoscopic radio-frequency ablation|Endobiliary radiofrequency catheter is 8Fr in diameter and can easily be passed over a 0.035 guide wire through the biopsy channel of a duodenoscope at the time of endoscopic retrograde cholangiography (ERC). Its use in the biliary system was heralded by animal experiments following which power settings of 7-10 Watts for 2 minutes were found to provide adequate ablation. The ablation results in charring of the tumor and this is expected to enhance the patency of SEMS
16215177|NCT01275755|Drug|Placebo|
16215178|NCT01275755|Drug|ADL5945 0.25 mg|
16215179|NCT01275742|Behavioral|Brief Cognitive Therapy Intervention|The intervention group will receive an individual, 30 minute, scripted cognitive therapy session. This intervention will be delivered by an Advanced Practice Registered Nurse or a trained research nurse. An iPad will guide the outline of the intervention. The nurse will discuss depression in heart disease and the connection between thoughts, emotions, and behaviors. The nurse will ask the patient to describe a recent stressful experience and discuss thoughts that the patient has been experiencing. Two techniques for challenging negative thinking will be introduced to the patient: thought stopping and affirmations. The nurse will ask the patient to practice these techniques at home. After the patient has practiced both techniques, the nurse will leave the patient with a booklet with the intervention. At 1-2 weeks, the nurse will administer a booster session over the phone. This session will last 10-15 minutes and will reinforce the techniques learned during the brief CT intervention.
16215180|NCT01275729|Drug|Furosemide|dose: 1 mg / kg (iv) if the patient is furosemide naive or 1.5 mg/kg (iv) if the patient is not furosemide naive
16215181|NCT01275716|Behavioral|Impact of Coronary Images Used During Patient Education on Coronary Artery Disease and Subsequent Lifestyle Modifications|Subjects will be randomly assigned (like the flip of a coin) to a study group. One group will be given before and after treatment pictures of their affected heart arteries. The other group will not be shown these pictures. Both groups will still receive written and verbal information about living a heart healthy lifestyle and taking heart medications properly as part of their normal routine care.
16215182|NCT01275677|Drug|Cyclophosphamide|Given IV
16215183|NCT01275677|Drug|Docetaxel|Given IV
16215184|NCT01275677|Drug|Doxorubicin|Given IV
16215185|NCT01275677|Drug|Doxorubicin Hydrochloride|Given IV
16215186|NCT01275677|Other|Laboratory Biomarker Analysis|Correlative studies
16215187|NCT01275677|Drug|Paclitaxel|Given IV
16215188|NCT01275677|Other|Quality-of-Life Assessment|Ancillary studies
16215189|NCT01275677|Biological|Trastuzumab|Given IV
16215190|NCT01275664|Procedure|Adjuvant Therapy|Ancillary studies
16215191|NCT01275664|Drug|Aprepitant|Given IV and PO
16215192|NCT01275664|Drug|Carboplatin|Given IP
16215193|NCT01275664|Drug|Cisplatin|Given IP
16215194|NCT01275664|Drug|Dexamethasone|Given PO
16215195|NCT01275664|Drug|Granisetron Transdermal Patch|Apply one patch to upper arm
16215196|NCT01275664|Procedure|Management of Therapy Complications|Ancillary studies
16215197|NCT01275664|Other|Questionnaire Administration|Ancillary studies
16215198|NCT01275651|Other|laboratory biomarker analysis|Correlative studies
16215199|NCT01275638|Drug|Prednisolone|Soon after the presumptive diagnosis of severe sepsis, initial laboratory specimens were obtained within 2 hours, and the patients were randomized to treatment with prednisolone or placebo groups. The treatment groups were determined by a computer-generated randomization procedure (in a 1:1 ratio). The steroid group received prednisolone at a moderate-dose (20 mg/day). Prednisolone was given intravenously at 06.00 (10 mg) 14.00 (5 mg) and 22.00 (5 mg) for 10 days. The standard therapy group received a placebo infusion containing physiological saline solution in an identical manner. Patients and their primary physicians were blinded as to which therapy was administered.
16215200|NCT01275625|Drug|HIV therapy|Combivir one tablet BD with maraviroc 300mg BD for 48 weeks
16215201|NCT01275612|Biological|Mesenchymal stromal cell infusion|The first 3 patients will receive a single i.v infusion of donor ex-vivo expanded MSC (1 x 106 MSC/kg). If the efficacy outcome of cell treatment is negligible or partial and the procedure is safe, a second group of additional 3 patients will be enrolled. They will be given MSC i.v infusion at higher dose (2 x 106 MSC/kg).Should the therapeutic efficacy of this treatment again negligible or marginal, but still safe, a third group of 3 patients will be enrolled in the study. The dose of cells to be infused will be up-titrated to 5 x 106 MSC/kg.
16215202|NCT01275599|Drug|telaprevir|Two 375 mg tablets administered every 8 hours on Day 1 through Day 7, inclusive.
16215203|NCT01275599|Drug|buprenorphine/naloxone|Buprenorphine/naloxone sublingual tablets or films contain buprenorphine HCl and naloxone HCl dihydrate at a ratio of 4:1 buprenorphine:naloxone (ratio of free bases). In this study buprenorphine/naloxone will be dosed from Day -14 through Day 38, inclusive. From Day -14 through Day -1 all subjects will receive a maximum of 24 mg/6 mg of buprenorphine/naloxone. Subjects will not be permitted to change their dose during the telaprevir co-administration period (Day 1 through Day 7) unless warranted by the investigator's clinical judgment of subject safety. After Day 8, the dose of buprenorphine/naloxone may be adjusted if deemed necessary by the investigator.
16215392|NCT01273974|Biological|intradermal influenza vaccine|0.25ml ,intradermal
16215393|NCT01273974|Biological|intramuscular influenza vaccine|0.5ml,intramuscular
16215204|NCT01275586|Drug|Tasigna|Following enrollment each subject will initially receive Tasigna orally at 200 mg twice daily for two weeks. If tolerated, the dose will be increased to 300 mg twice daily after a minimum of two weeks and will be increase to a maximum dose of 400mg twice daily after an additional two weeks if tolerated.
16215205|NCT01275573|Device|Repetitive Transcranial Magnetic Stimulation|Repetitive Transcranial Magnetic Stimulation will be applied on the contralateral primary cortical motor on the painful side for the Parkinson's disease patients and on the left primary cortical motor for the healthy volunteer. The stimulation frequency will be 20 Hz during 26 min with an intensity stimulation equal of 95% of the motor threshold.
16215206|NCT01275560|Drug|Metronidazole|Metronidazole,per os,500mg, 3 per day during 10 days
16215207|NCT01275560|Drug|CArbosylane|
16215208|NCT01275547|Drug|s-ketamine & midazolam|s-ketamine 6 mg intranasal midazolam 0.75 mg intranasal
16215209|NCT01275547|Drug|Morphine PCA|2 mg Morphine i.v. all 12 minutes as a patient controlled system
16215210|NCT01275521|Drug|BONT-A intra-prostatic injection|"• Intra prostatic injection of 200 IU of BONT-A (2 x 100 IU to dilute in 10 cc salted serum), divided into 4 injections, 2 in each prostate lobe for a volume intra injected 2.5 cc per site.
~Interruption of the medical therapy 1 month after the injection;"
16215211|NCT01275521|Drug|Optimized medical BPH treatment|Optimization of the medical therapy according to recent guidelines
16215212|NCT01275508|Drug|FITC-Adalimumab|The study product FITC-Adalimumab will be topically applied via a spray catheter to the intestinal mucosa of Crohn's disease patients during endomicroscopy of the gut. One mL of the diluted study product will be applied each time to overall four selected intestinal areas at a concentration of 20 μg/mL respectively (equivalent to 20 μg of FITC-Adalimumab per area). Total amount applied will be 80 μg FITC-Adalimumab per patient.
16215213|NCT01275495|Behavioral|Telephone Assessment and Skill-Building Kit (TASK II)|
16215214|NCT01275495|Behavioral|Information, Support, and Referral (ISR)|
16215215|NCT01275482|Procedure|Transverse friction massage (TFM)|The TFM was describe of Cyriax as an effective method to treat soft tissues. It is a massage done always in perpendicular direction of damage tissue. During the massage, we can caused isolated contractions from the fiber muscles containing the latent trigger points.
16215216|NCT01275482|Procedure|Transverse friction massage (TFM)|The TFM was describe of Cyriax as an effective method to treat soft tissues. It is a massage done always in perpendicular direction of damage tissue.
16215217|NCT01275469|Drug|GFT505 80mg|Hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast.
16215218|NCT01275469|Drug|Placebo|Hard gelatin capsules, oral administration, 4 capsules per day before breakfast.
16215219|NCT01275456|Procedure|Exposure to house dust mite|0 SQE/qm for 4 hours 250 SQE/qm for 4 hours 500 SQE/qm for 4 hours 1000 SQE/qm for 4 hours
16215220|NCT01275443|Drug|300mg TMC278LA|300mg TMC278LA intramuscular injection
16215221|NCT01275443|Drug|150mg TMC278LA|150mg TMC278LA intramuscular injection
16215222|NCT01275443|Drug|1200mg TMC278LA|1200mg TMC278LA intramuscular injection
16215223|NCT01275443|Drug|600mg TMC278LA|600mg TMC278LA intramuscular injection
16215224|NCT01275430|Device|Sherlock 3CG|Sherlock 3CG is indicated for central venous catheter guidance and positioning during catheter placement. The Sherlock 3CG provides real time catheter tip location information through the use of passive magnet and cardiac electrical signal detection.
16215225|NCT01275430|Other|Blind Placement|"PICCs will be placed blindly, without the use of any tip location/positioning device."
16215226|NCT01275404|Behavioral|Sexual Medicine Rehabilitation Program + nurse practitioner information phone calls|"Baseline Assessment which is 90-minute patient focus group interviews. SMRP, provided to all participating patients, consists of the following steps: 1) An introductory visit with SMRP Director, Dr. Mulhall, to orient the patient to post-surgery erectile rehabilitation and assess the patients success with PDE-5 inhibitors; 2) Penile injection training provided by a NP over two visits, with follow-up calls as necessary until injection method and dose are deemed correct; 3) Follow-up visits with Dr. Mulhall every 4 months to monitor progress with rehabilitation. Study assessments will be administered at baseline, at 4-8 months post baseline (follow up 1) and 4-8- months post follow up 1 (follow up 2)."
16215227|NCT01275404|Behavioral|Sexual Medicine Rehabilitation Program + Acceptance and Commitment Therapy for Erectile Dysfunction|Baseline Assessment which is 90-minute patient focus group interviews. SMRP+ACT-ED will receive four individual ACT-ED counseling sessions (60 minutes each) over a period of approximately four months, and will also be followed up with questionnaires 4 and 8 months post baseline These sessions focus on the four core elements of ACT: values, acceptance, exposure, and commitment. Study assessments will be administered at baseline, at 4-8 months post baseline (follow up 1) and 4-8- months post follow up 1 (follow up 2).
16215228|NCT01275391|Behavioral|Computer Screening, Brief Intervention, Referral toTreatment|A computerized screening for tobacco, alcohol and drug use accompanied by 10-15 pages of health information regarding the risks of tobacco, alcohol and drug use. This is followed by a brief conversation with the primary care provider regarding the health risks of tobacco, alcohol and drug use and a referral to treatment for those at high risk of substance use problems.
16215229|NCT01275378|Behavioral|Collaborative Care Plus|Traditional collaborative care + systematic addressing of ADHD comorbidities, parental mental health issues, and adherence to treatment plans
16215230|NCT01275378|Behavioral|Traditional Collaborative Care|Traditional collaborative care, in which care managers serve as intermediaries between primary care physicians and specialists
16215231|NCT01275365|Drug|Testosterone enanthate|Testosterone enanthate 100 mg intramuscularly weekly
16215232|NCT01275365|Drug|Testosterone enanthate|Testosterone enanthate 100 mg intramuscularly weekly
16215233|NCT01275352|Drug|Eplerenone|Eplerenone 50 mg/day
16215234|NCT01275352|Drug|placebo|placebo
16215235|NCT01275339|Drug|Tadalafil|Active drug will be encapsulated to look identical to the placebo pill. Subjects will take a single oral dose of tadalafil once daily from the time of randomization until study completion (6 months). Subjects will begin by taking 20 mg (1 pill) daily for 3 days before having the dose increased to 40 mg (2 pills) once daily. If the increase to 40mg daily is not tolerated, then the dose will be decreased back to 20mg daily.
16215274|NCT01275066|Drug|BMN 110 Weekly|BMN 110 Weekly: Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours once a week.
16215236|NCT01275339|Drug|Placebo|The placebo pill will be encapsulated to look identical to the active drug pill. Subjects will take a single oral dose of placebo once daily from the time of randomization until study completion (6 months). Subjects will begin by taking 1 pill daily for 3 days before having the dose increased to 2 pills once daily. If the increase to 2 pills is not tolerated, then the dose will be decreased back to 1 pill daily.
16215237|NCT01275313|Device|Lightweight wheelchair|Seating and wheeled mobility assessment and fitting of a lightweight wheelchair
16215238|NCT01275313|Device|Skin Protection Cushion|Seating assessment and provision of a cushion meeting CMS code for Skin Protection wheelchair cushion
16215239|NCT01275300|Drug|Aspirin|
16215240|NCT01275300|Drug|Placebo|
16215241|NCT01275300|Drug|Niacin|
16215242|NCT01275287|Drug|Standard of care treatment|"induction : pulse methyl prednisolone (7 mg/kg/day x3) then prednisone 1 mg/kg/day (not to exceed 60 mg/day) for 4 weeks, then taper over the following 12 weeks. Cyclophosphamide starting at 0.75 gm/m2 IV (decreased to 0.5 gm/m^2 for patients > than 70 or with estimated Glomerular Filtration Rate (eGFR) < 20 ml/min) to be titrated up to 1 gm/m^2 depending on the 2 week white blood count (WBC) nadir > 3000 cell/μL. Subsequent cyclophosphamide will be given every 4 weeks for at least 2 more doses. Once complete remission for 2 months, patient may be switched from cyclophosphamide to maintenance therapy with azathioprine 1.5-2 mg/kg/day for 6-9 months (to a total of 12 months of therapy) .
~For patients who cannot tolerate cyclophosphamide, or who have received it in large doses previously, another medication called rituximab may be used instead. However, if rituximab is indicated for the patient, he cannot participate in the study."
16215243|NCT01275287|Drug|eculizumab|In addition to conventional therapy, patients randomized to eculizumab will receive 600 mg by IV infusion over 35 minutes every 7 days for the first 4 weeks, then 900 mg by IV infusion for the fifth dose 7 days later (week 5), then 900 mg every 14 days thereafter, for a total of 9 doses (about 3 months of treatment). This dosing scheme is based on that used for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH). The length of treatment is shorter than for PNH, based on a desire to target the addition of eculizumab to the period of maximal disease activity, while limiting the risks of infectious complications in this first pilot study.
16215244|NCT01275274|Drug|Retinoic acid|Patients will be started at half the recommended dose of retinoic acid for the treatment of acute promyelocytic leukemia (APL), i.e. 22.5mg/m2/day orally in two divided doses, to minimize the risk of adverse events. If there is no decrease in PR3/MPO gene expression to a fold change of < 2 by quantitative polymerase chain reaction(QT-PCR) technique for PR3 at the end of 4 weeks, the dose will be increased to 45 mg/m2/day in two divided doses for an additional 8 weeks. If the patient shows a decrease in PR3/MPO gene expression to < 2 at 4 weeks, the patient will remain on the same dose for the remainder of 12 weeks. All patients will be followed for a total of 12 months for safety evaluations and to assess changes in disease activity and the incidence of disease relapse.
16215245|NCT01275274|Drug|Standard of care|maintenance therapy with azathioprine or mycophenolate mofetil with or without small dose prednisone. Dose, frequency and duration depend on disease activity (partial or complete remission).
16215246|NCT01275261|Behavioral|Nursing protocol to avoid Foley catheter placement|A specific nursing order protocol will be followed addressing urinary care to try to avoid the use of Foley catheters.
16215247|NCT01275248|Drug|Ondansetron|Oral tablets in 0.5mg or 0.75mg strength
16215248|NCT01275248|Drug|Placebo|Oral tablet to match the experimental interventions
16215249|NCT01275222|Drug|RAD001|RAD001 was in tablets of 0.5 mg, 1.0 mg, 2.5 mg and 5.0 mg strength and was taken by mouth, once a week or once a day depending upon the treatment group the patient was enrolled into.
16215250|NCT01275222|Drug|Imatinib 600mg/day (Glevec is the brand name for imatinib)|Glivec/Gleevec was supplied as commercialized 100 mg and 400 mg tablets. Gleevec/Glivec was provided as capsules of 100 mg strength in bottles containing 60 capsules each. The use of this supply was study center specific. Glivec/Gleevec was taken, by mouth, at a dose of 300 mg twice a day. The Glivec/Gleevec regimen was changed from 600 mg once a day to 300 mg BID, by an amendment since taking too many tablets at once was difficult for patients with gastro-intestinal disease. In the phase II part of the study all patients received Glivec 600 mg/day.
16215251|NCT01275222|Drug|Imatinib 800mg/day (Glevec is the brand name for imatinib)|Glivec/Gleevec was supplied as commercialized 100 mg and 400 mg tablets. Gleevec/Glivec was provided as capsules of 100 mg strength in bottles containing 60 capsules each. The use of this supply was study center specific. Glivec/Gleevec was taken, by mouth. In the phase II part of the study all patients received Glivec 600 mg/day, except for 2 patients who received Glivec at a dose of 800 mg/day. This dose was permitted in Phase II as it was found to be safe in Phase I.
16215252|NCT01275209|Drug|HCD122|
16215253|NCT01275196|Drug|Nilotinib|
16215254|NCT01275196|Drug|Imatinib|
16215255|NCT01275183|Drug|raltegravir and cisplatin|"Cisplatin, intravenous, 30 mg/m2, days 2 and 16, 1 to 2 hours
~Raltegravir, oral,400 mg, twice per day, days 1 through 5 or days 15 to 19
~Part 2 (optional): Docetaxel, intravenous, 75 mg/M2, day 2, every 21 days, 3 to 6 cycles
~Part 2 (optional): Cisplatin, intravenous, 75 mg/M2, day 2, every 21 days, 3 to 6 cycles
~Part 2: (optional): Raltegavir, oral, 400 mg, twice per day, days 1 through 5, 3 to 6 cycles"
16215256|NCT01275170|Drug|MK-7655|125 mg intravenous (IV) over 30 minutes as a single dose
16215257|NCT01275170|Drug|Imipenem + Cilastatin|250 mg IV over 30 minutes as a single dose
16215258|NCT01275170|Drug|Caffeine|Caffeine caplet, single 200 mg dose, orally
16215259|NCT01275170|Drug|Midazolam|Midazolam hcl syrup single 2.0 mg dose by mouth.
16215260|NCT01275170|Drug|Omeprazole|Omeprazole tablets, single 40 mg dose (as two 20 mg tablets), orally
16215261|NCT01275157|Drug|LY2452473|Administered orally as a liquid suspension
16215262|NCT01275144|Drug|LY2216684|Administered orally
16215263|NCT01275144|Drug|Placebo|Administered orally
16215264|NCT01275144|Drug|Lorazepam|Administered orally
16215265|NCT01275131|Drug|Insulin aspart|
16215266|NCT01275131|Drug|Recombinant human hyaluronidase PH20 (rHuPH20)|
16215267|NCT01275118|Device|Tecnis Multifocal IOL|Presbyopia correcting IOL
16215268|NCT01275118|Device|crystalens Accommodating IOL|Presbyopia correcting IOL
16215269|NCT01275105|Drug|Vehicle|one drop in each eye at designated visits
16215270|NCT01275105|Drug|Brimonidine Tartrate 0.01%|one drop in each eye at designated visits
16215271|NCT01275105|Drug|Brimonidine Tartrate 0.025%|one drop in each eye at designated visits
16215275|NCT01275066|Drug|Placebo|Intravenous infusion of placebo solution at a volume equivalent to that needed for 2.0 mg/kg dose of BMN 110 administered over a period of approximately 4 hours once a week.
16215276|NCT01275066|Drug|BMN 110 Every Other Week|BMN 110 Every Other Week: Intravenous infusion of BMN 110 at a dose of 2.0 mg/kg administered over a period of approximately 4 hours every other week and infusions of placebo on alternating weeks.
16215277|NCT01275053|Drug|leptin|0.01mg/kg
16215278|NCT01275040|Other|Mobile screening; Health Education|Active screening for diabetes complications - neuropathy screening, retinopathy screening, blood and urine tests. Health education for both patients and health workers on diabetes. Active collaboration between primary and tertiary care in the public health system.
16215279|NCT01275040|Other|Health education|Health education given to both patients and healthcare workers. No mobile screening team will visit facilities and no interaction between primary and tertiary care will be evaluated.
16215280|NCT01275027|Dietary Supplement|Nutralin|7 capsules taken 15 minutes before each of the three main meals of the day
16215281|NCT01275014|Drug|Dexamethasone|1 ml of 20mg/ml solution was applied once, following the arthrocentesis procedure of the TMJ
16215282|NCT01275014|Drug|Isotonic saline|1 ml of isotonic saline was applied once, following the arthrocentesis procedure of the TMJ
16215283|NCT01274988|Procedure|Deep brain stimulation|Deep brain stimulation of bilateral nucleus accumbens
16215284|NCT01274988|Other|methadone maintenance treatment|methadone maintenance treatment
16215285|NCT01274975|Other|Autologous Adipose Derived Mesenchymal Stem Cells|Intravenous infusion of Autologous Adipose Derived Mesenchymal Stem Cells. Dose : 4 x 10e8 cells
16215286|NCT01274962|Drug|FOLFOX|"Oxaliplatin* 85 mg/m2 IV in 500 mL of D5W over 120 minutes
~Folinic Acid (Leucovorin)* 400 mg/m2 IV in 250 ml D5W over 120 minutes
~5-Fluorouracil (5-FU) 400 mg/m2 IV bolus, after Folinic Acid
~5-Fluorouracil** 2400 mg/m2 IV over 46 h in D5W to a total volume of 92 mL by continuous infusion at 2 mL/hour.
~Repeat every 14 days for 6 cycles in the arm A and to be completed with 6 cycles after surgery and 12 cycles in arm B.
~If necessary the schedule may be modified +/- 3 days."
16215287|NCT01274962|Radiation|high dose rate endorectal brachytherapy|High dose rate endorectal brachytherapy, consisting in a total dose of 26 Gy in 4 daily fractions of 6.5 Gy.
16215288|NCT01274949|Device|LI-ESWT|Low intensity shock wave treatment - 12 sessions
16215289|NCT01274936|Drug|Qishe Pill|Pill, 3.75 g, twice per day, four weeks
16215290|NCT01274936|Drug|Qishe Placebo|Pill, 3.75 g, twice per day, four weeks
16215291|NCT01274923|Device|"MEDISPEC treatment probe"|shock wave treatment
16215292|NCT01274910|Dietary Supplement|EPAX 6000 EE 1000mg (0.6 gr DHA+EPA)|"Patient will receive Fish Oil capsules (EPAX 6000 EE) .
~Treatment: 5 capsules per day"
16215293|NCT01274910|Dietary Supplement|Capsules (Placebo)|"Patient will receive capsules which not contain fish oil.
~Treatment: 5 capsules per day"
16215294|NCT01274897|Biological|Novartis MenACWY-CRM|All subjects had blood drawn at Day 1 and Day 29.
16215295|NCT01274897|Biological|Saline Placebo|All subjects had blood drawn at Day 1 and Day 29.
16215296|NCT01274884|Procedure|Tightrope fixation|Arthroscopic repair
16215297|NCT01274845|Other|Heliox mechanical ventilation|Mechanical ventilation (MV) with air-oxygen at baseline, then 1 hour of heliox (helium-oxygen) MV and then return to MV with air-oxygen.
16215298|NCT01274832|Device|Deep Brain Stimulation|Deep Brain Stimulation of STN in Parkinsonian patients
16215299|NCT01274819|Other|Dynamic Light|Dynamic Light Application (DLA) is a light application which exposes the subject in the room to a varying light intensity and light temperature during the day thus mimicking a natural daylight exposure.
16215300|NCT01274806|Other|Physical Therapy|Core Stability Exercise, Endurance training, recovery massage
16215301|NCT01274793|Drug|Mosapride Citrate tablet|Orally administered 5 mg mosapride citrate tablet s three times a day for 4 continuous weeks if no severe adverse effects were found.
16215302|NCT01274793|Device|Low-dose acupuncture|In this low current intensity group, the current applied would be relatively weak,it was clearly perceived by the participants
16215303|NCT01274793|Device|High-dose acupuncture|In this group,the current was strong enough to reach the patients'tolerance threshold value.
16215304|NCT01274780|Drug|Darunavir / Ritonavir + Tenofovir / Emtricitabine|oral, 800/100 mg, qd + oral, 300/200 mg, qd
16215305|NCT01274780|Drug|Atazanavir / Ritonavir + Tenofovir / Emtricitabine|oral, 300/100 mg, qd + oral, 300/200 mg, qd
16215306|NCT01274741|Behavioral|Creating Change (CC)|Creating Change is a past-focused, integrated, cognitive-behavioral therapy for PTSD/SUD. It has 17 topics, which in this study were delivered in weekly one-hour sessions, in individual format. The treatment explores how PTSD and SUD arose and interacted across the patient's life, including constructing a narrative of its meaning, processing associated emotions and memories, and exploring themes related to these.
16215307|NCT01274741|Behavioral|Seeking Safety (SS)|Seeking Safety is a present-focused, evidence-based cognitive-behavioral therapy for integrated treatment of patients with PTSD/SUD. It is a cognitive-behavioral therapy comprising 25 topics, each a coping skill relevant to both disorders. In this study 17 of the 25 topics were conducted, one per weekly, one-hour, individual session.
16215308|NCT01274728|Procedure|Percutaneous coronary intervention|Percutaneous coronary intervention with at least use of drug-eluting balloon and if necessary cross-over to bail-out stenting with BMS.
16215309|NCT01274715|Behavioral|Behavioral Health Coaching|Behavioral health coaching consisting of goal-setting, action planning, behavioral activation, and cognitive therapy is delivered by telephone over approximately 3 months.
16215310|NCT01274702|Other|Visual Reconstitutions Therapy|
16215311|NCT01274702|Other|Saccadic Eye Movement Training|
16215312|NCT01274689|Other|individually tailored lead weight|patients were treated with an individually tailored lead weight to train M. orbicularis oculi during day time
16215313|NCT01274676|Device|carotid stenting with MOMA|The MOMA system is an endovascular catheter for proximal protection during carotid stenting. The system allows a concomitant balloon occlusion of both external and common carotid arteries leading to blood flow reversal within the internal carotid artery.
16215349|NCT01274377|Biological|CMV Specific T Cell donor lymphocyte infusion|Donor Lymphocyte Infusion (DLI)
16215507|NCT01272973|Drug|semaglutide|Administered s.c. (under the skin) once weekly for 10 weeks. Individually adjusted dose investigated up to maximum level.
16215314|NCT01274676|Device|Carotid stenting with filter wire EZ|The filter wire EZ a distal protection system that is placed in he distal internal carotid artery before carotid stenting. The filter should entrap almost all the debries that are generated during endovascular procedure. At the end of the procedure the filter is retrieved throught a dedicated retrieval catheter.
16215315|NCT01274663|Drug|PF-05175157 or Placebo|One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.
16215316|NCT01274663|Drug|PF-05175157 or Placebo|One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.
16215317|NCT01274663|Drug|PF-05175157 or Placebo|One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.
16215318|NCT01274663|Drug|PF-05175157 or Placebo|One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.
16215319|NCT01274663|Drug|PF-05175157 or Placebo|One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.
16215320|NCT01274663|Drug|PF-05175157 or Placebo|One dose of PF-05175157 will be administered as a powder-in-capsule in the fasting state in the AM; correspondingly, one dose of a matched powder-in-capsule placebo will be administered in the fasting state in the AM.
16215321|NCT01274663|Drug|PF-05175157 or Placebo|One dose of PF-05175157 will be administered as a powder-in-capsule immediately after breakfast; correspondingly, one dose of a matched powder-in-capsule placebo will be administered immediately after breakfast.
16215322|NCT01274650|Procedure|Indirect Calorimetry|Indirect Calorimetry
16215323|NCT01274637|Drug|Dalteparin Sodium|5,000 IU/0.2ml (anti-Xa) administered once daily in prefilled glass syringes.
16215324|NCT01274624|Biological|REOLYSIN®|1 hour intravenous infusion administered on Days 1, 2, 3, 4, and 5 every 4 weeks.
16215325|NCT01274624|Drug|Irinotecan|90-minute intravenous infusion on Day 1 every 2 weeks. Dose levels of 125 mg/m2, 150 mg/m2, 150 mg/m2, 180 mg/m2.
16215326|NCT01274624|Drug|Leucovorin|2-hour infusion of 400 mg/m2 on Day 1 every 2 weeks.
16215327|NCT01274624|Drug|Fluorouracil (5-FU)|400 mg/m2 intravenous bolus followed by 2400 mg/m2 as a continuous intravenous infusion over 46 hours administered on Day 1 every 2 weeks.
16215328|NCT01274624|Drug|Bevacizumab|30, 60 or 90 minute infusion on Day 1 every 2 weeks. Dose level 5 mg/kg.
16215329|NCT01274611|Drug|Botulinum Toxin Type A|Botox will be injected into the underarm, targeting the sweat glands, to stop underarm sweating.
16215330|NCT01274611|Device|Suction-Curettage|The doctor will insert a suction tool into two small incisions in order to suction out the sweat-producing glands. It is similar to liposuction, but instead of suctioning out fat, the doctor suctions out the layer of the deep skin where the sweat glands are located to decrease underarm sweating.
16215331|NCT01274598|Biological|Lactobacillus Rhamnosus GG, ATCC 53103 (LGG)|1x10^10 CFU by mouth twice daily for 28 days
16215332|NCT01274585|Device|Posterior tibial nerve stimulation (PTNS)|Stimulation using PTNS device for 30 minutes weekly for 12 weeks
16215333|NCT01274585|Device|Posterior tibial nerve stimulation|Sham needle placement without active PTNS device for 30 minutes weekly for 12 weeks
16215334|NCT01274559|Drug|Extended-release niacin/laropiprant (ERN/LRPT)|1 oral 1 g tablet of ERN/LRPT to be taken with food in the evening or at bedtime for the first 4 weeks of treatment; then 2 oral 1g tablets of ERN/LRPT to be taken together in the evening or at bedtime with food for the next 8 weeks. Each 1g tablet contains 1g ERN and 20 mg LRPT
16215335|NCT01274559|Drug|Placebo|1 oral 1 g tablet of placebo to be taken with food in the evening or at bedtime for the first 4 weeks of treatment; then 2 oral 1g tablets of placebo to be taken together in the evening or at bedtime with food for the next 8 weeks.
16215336|NCT01274546|Device|cruciate-retaining Foundation Knee system|subjects who received the cruciate-retaining Foundation Knee system greater than or equal to 10 years ago and still maintain the original device in their knee.
16215337|NCT01274533|Drug|Lenalidomide|25mg or 10mg (based on creatinine clearance) once daily for days 1-21 of a 28 day cycle
16215338|NCT01274520|Device|The Medtronic Portable Bypass System (PBS®)|Will be used for machine perfusion of liver grafts.
16215339|NCT01274507|Other|Medical tests|All participants will undergo medical tests and will be observed.
16215340|NCT01274481|Drug|Iloprost|patients inhale 20 mcg of Iloprost via nebulizer and, if oxygenation and blood pressure is maintained receive a second dose of 20 mcg of Iloprost 30 minutes later.
16215341|NCT01274455|Genetic|Gene Therapy product CYL-02 = plasmid DNA pre-complexed to linear polyethylenimine encoding sst2 + dck::umk genes|Intratumoral injection of the gene therapy product CYL-02 (2,5 ml within the primary tumor under endoscopic ultrasound guidance an under propofol anaesthesia). The intratumor injection of CYL-02 is followed by three IV infusions of Gemcitabine (1000 mg/m2) at 48 hours and then every two weeks. A second Intratumoral injection of the gene therapy product CYL-02 is performed at a same dosage and volume 30 days after the first administration followed by Three infusions of gemcitabine (1000 mg/m2) according the same rhythm (48 hours and every week) and dose.
16215342|NCT01274442|Other|anamnesis|To update the anamnesis.
16215343|NCT01274442|Procedure|oral examination|A brief clinical oral examination will be performed.
16215344|NCT01274442|Procedure|Blood sample|A blood sample will be taken to identify relevant genetic polymorphisms.
16215345|NCT01274429|Drug|Peanut flour|Peanut flour that is ingested daily and administered in gradually increasing amounts up to a maximum maintenance dose.
16215346|NCT01274416|Behavioral|Acceptance and Commitment Therapy|The stated goal of this intervention is to increase willingness to experience difficult thoughts, feelings, and bodily sensations in order to engage in flexible action.
16215347|NCT01274416|Behavioral|Parent Skills Training|Skills Training for parents that provides psychoeducation for eating disorder and skills in behavior management, self-regulation, and emotion regulation.
16215348|NCT01274403|Drug|Melphalan, Prednisone and Thalidomide|
16218141|NCT01252745|Drug|10.0 mg of Testosterone, 4.0% TID|
16215350|NCT01274364|Other|JADE|Patients will receive comprehensive assessments at baseline and again after 12-months. In the interim between these two time points patients will receive protocol-driven diabetes care using a web-based disease management program (JADE), delivered by a trio-team comprising of a trained doctor, nurse and physician assistant.
16215351|NCT01274364|Other|DIAMOND|Patients will receive comprehensive assessments at baseline and again after 12-months. In the interim between these two time points patients will be managed according to 'usual care' procedures.
16215352|NCT01274351|Drug|Nilotinib|administered orally at a dose of 300 mg twice daily for 24 months
16215353|NCT01274338|Biological|Ipilimumab|Given IV
16215354|NCT01274338|Biological|Alfa Interferon|Given IV and SC
16215355|NCT01274325|Drug|Sereflo|Patients take sereflo (25/125) 2 puffs twice a day for 4 weeks
16215356|NCT01274325|Drug|Seretide|Patients will take Seretide (25/125) 2 puffs twice a day for 4 weeks
16215357|NCT01274312|Procedure|Xiao procedure|Cross over surgery. Proximal part of L5 Ventral root is anastomosed to distal part of ventral root of S2 or S3 producing a somato-sensory reflex arch
16215358|NCT01274299|Procedure|Digital camera picture|A digital camera will be used to take a 3D picture the face of each infant. Off line measurements of landmarks on the face will be marked and dimensions will be calculated using a special analysis software.
16215359|NCT01274273|Drug|Interleukin-2|2.4 MIU/m2 s.c. two times daily, 5 days per week, weeks 1 and 2, every 28-day-cycle, for a maximum of 9 cycles (i.e.for a maximum of 9 months).
16215360|NCT01274273|Drug|Interferon Alfa-2b|IFN-alfa given as one priming-week of daily IFN 3.0 MIU, followed by up to 9 treatment cycles (i.e. for a maximum of 9 months) with IFN-alfa 3.0 MIU as a fixed dose s.c. once daily - 5 days per week.
16215361|NCT01274273|Drug|Bevacizumab|Bevacizumab doses of 10 mg per kilogram of body weight, given every two weeks i.v. until disease progression, unacceptable toxicity, withdrawal of consent or a maximum of 1 year following obtaining no evidence of disease (NED).
16215362|NCT01274260|Drug|methylprednisolone|Subjects in this group will receive a loading dose of methylprednisolone 2mg/kg followed by 1mg/kg/day of methylprednisolone infusion from day 1 to day 7; 0.5mg/kg/d from days 8 to 10, 0.25mg/kg/d on days 11 and 12, 0.125mg/kg/d on days 13 and 14. The study drug infusion will be discontinued after 14 days.
16215363|NCT01274260|Drug|Normal Saline (0.9%)|The placebo will be 0.9% (normal) saline and the active medication will be diluted in 0.9% (normal) saline.
16215364|NCT01274247|Drug|Topical Benzocaine|Topical administration of a drop of benzocaine to the lingual frenulum
16215365|NCT01274234|Device|COMBO Stent (OrbusNeich Medical, Fort Lauderdale, Florida)|The COMBO Stent is a hybrid version of the GENOUS Stent. Upon implantation to the coronary artery, the stent will deliver a drug (sirolimus) to the wall of the treated segment to suppress neointimal growth, in addition to the anti-CD34 antibody coating which will in theory attract circulatory endothelial progenitor cells to hasten endothelialization and promote healing of the stented segment, and thereby may reduce late stent thrombosis.
16215366|NCT01274221|Drug|SPD489|1 capsule per day throughout the open-label treatment phase and for one week of the double-blind crossover phase
16215367|NCT01274221|Other|Placebo|1 capsule per day for one week of the double-blind crossover phase
16215368|NCT01274195|Drug|Busulfan|First dose: busulfan (120 mg/m2 ivs once daily) (if age<1 yr: 80 mg/ m2) Second to forth dose: according to the daily pharmacokinetic study
16215369|NCT01274182|Biological|GP2013|1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
16215370|NCT01274182|Biological|MabThera|1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
16215371|NCT01274182|Biological|Rituxan|1000 mg iv infusion on two separate occasions, two weeks apart (i.e. on Day 1 and on Day 15)
16215372|NCT01274156|Device|"MEDISPEC treatment probe"|300 shocks in 5 different anatomical locations of the penis.
16215373|NCT01274156|Device|"MEDISPEC Sham Probe"|Sham probe applied same as treatment probe without energy
16215374|NCT01274156|Device|"MEDISPEC Low intensity shock waves"|Treatment parameters will be as follows: Intensity: 0.09 mj/mm2 ,300 shocks per site, on 5 penile anatomical sites. Total number of shock waves: 1500/ session Frequency of 120/min
16215375|NCT01274156|Device|Sham|Probe does not deliver energy but creates same noise and sensation of active probe
16215376|NCT01274143|Behavioral|TeleCARE|Personalized telephone-delivered cancer risk assessment.
16215377|NCT01274143|Behavioral|Pamphlet intervention|Mailed pamphlet about familial colorectal cancer risk and screening.
16215378|NCT01274130|Drug|Metformin|Diavex 1000mg on Day1 and 750mg on Day2
16215379|NCT01274117|Procedure|Transposition of the basilic vein and anastomosis with the brachial vein|One-stage vs two-stage transposition of the basilic vein
16215380|NCT01274104|Dietary Supplement|Vitamin D3|15,000 IU of Vitamin D3 every day for 14 days
16215381|NCT01274104|Other|Placebo|Placebo
16215382|NCT01274091|Other|PUFA-diet|Diets will contain 30% of energy as fat, 18% as protein and 52% as carbohydrates: polyunsaturated fatty acid diet (PUFA) will have P/S ratio 1.0.
16215383|NCT01274091|Other|SAFA-diet|Diets will contain 30% of energy as fat, 18% as protein and 52% as carbohydrates: Saturated fatty acid diet (SAFA) will polyunsaturated/saturated (P/S) ratio of 0.3.
16215384|NCT01274078|Biological|Blueberries|150 grams of frozen blueberries on the same day as exercise
16215385|NCT01274065|Genetic|Genetic analysis|The research team will review data following DNA sample analysis and identify variants in genes that result in impaired drug metabolism
16215386|NCT01274052|Other|Meal test|Liquid meal test
16215387|NCT01274039|Drug|Acetazolamide for glaucoma patients to lower eye pressure|Acetazolamide tablets 3 times daily for 3 to 4 weeks
16215388|NCT01274026|Drug|sapropterin dihydrochloride|"In 30 PKU patients found previously to exhibit no decrease in blood PHE levels behavioral and cognitive function, neurotransmitter levels, and gene expression of enzyme activity will be measured at baseline and after 4 weeks of Kuvan administration. Rating inventories of executive function performance and behavior will be administered to patients and parents.
~Urine neurotransmitters, blood microarray expression, and plasma amino acids will be measured (plasma PHE and TYR levels will also be measured at weeks 1 and 2). Nutrient analysis of 3 day food diaries will be conducted."
16215389|NCT01274000|Drug|YM060|oral
16215390|NCT01274000|Drug|placebo|oral
16216107|NCT01268449|Radiation|Placebo|The act of radiating laser to the ear is done while the set is off.
16215394|NCT01273961|Device|AuraLevée treatment|A single treatment, on day 0, on each of no more than two treatment sites, using the AuraLevée device. Treatment sites are the face, abdomen, upper arm, thigh or neck.
16215395|NCT01273948|Drug|Bavituximab|"Bavituximab 3 mg/kg given by intravenous (IV) infusion once weekly, plus oral ribavirin 1000 mg (weight <75 kg) or 1200 mg (weight greater than or equal to 75 kg) divided into twice-daily doses, for 12 weeks or
~Bavituximab 0.3 mg/kg given by IV infusion once weekly, plus oral ribavirin 1000 mg (weight <75 kg) or 1200 mg (weight greater than or equal to 75 kg) divided into twice-daily doses, for 12 weeks or"
16215396|NCT01273948|Drug|Pegylated interferon (PEG-IFN)|Pegylated interferon (PEG-IFN) alpha-2a 180 micrograms given by subcutaneous (SC) injection once weekly, plus oral ribavirin 1000 mg (weight <75 kg) or 1200 mg (weight greater than or equal 75 kg) divided into twice-daily doses, for 12 weeks
16215397|NCT01273922|Biological|NDV-3 investigational vaccine|Two doses of vaccine 6 months apart or placebo(only one dose at Time 0) administered intramuscularly
16215398|NCT01273909|Procedure|Perforator Flap Breast Reconstruction|perforator flap breast reconstruction with or without vascularized lymph node transfer
16215399|NCT01273909|Procedure|Vascularized Lymph Node Transfer|perforator flap vascularized lymph node transfer with or without concomitant perforator flap breast reconstruction
16215400|NCT01273896|Drug|STA-9090|All patients will receive 200 mg/m2 of STA-9090 once weekly by a 1-hour IV infusion for three consecutive weeks followed by a 1 week dose-free interval. Subjects tolerating therapy may continue on study until disease progression.
16215401|NCT01273883|Dietary Supplement|Magnesium|Magnesium 532 mg a day
16215402|NCT01273883|Other|Placebo|matching form/dosage
16215403|NCT01273857|Procedure|Autologous cardiac progenitor cell transplantation|Patients will receive 0.3 million / kg of autologous cardiac progenitor cells via intracoronary delivery 1 month after cardiac surgery. Follow-up visits 3 months to 1 year after cell injection will need to prospectively verify the clinical, laboratory, and safety-related data.
16215404|NCT01273857|Procedure|staged shunt procedure|Norwood-Glenn, Glenn, or Fontan procedure will be applied
16215405|NCT01273844|Drug|Bortezomib|Bortezomib
16215406|NCT01273831|Drug|atracurium|atracurium, Drop,0.5 mg/kg, one time, one day
16215407|NCT01273831|Drug|cisatracurium|cisatracurium, drop,0.15mg/kg,one time, one day
16215408|NCT01273818|Drug|Gentamicin and cefazolin|80 mg topically, intra-operative,single dose and intravenous 1000 mg cefazolin 1 hour before operation
16215409|NCT01273818|Drug|Cefazolin|1000 mg cefazolin application intravenously 1 hour before operation
16215410|NCT01273818|Drug|Gentamicin|80 mg gentamicin application intraoperatively
16215411|NCT01273805|Drug|Hydroxychloroquine|
16215412|NCT01273779|Drug|Talactoferrin alfa|15 mL of an oral solution of 100mg/mL (1.5 g) given 3 times a day for up to 28 days or until discharge from the intensive care unit
16215413|NCT01273779|Drug|Placebo|15 mL of oral solution of placebo given 3 times a day for up to 28 days or until discharge from the intensive care unit
16215414|NCT01273766|Drug|deferasirox|Given orally
16215415|NCT01273766|Other|laboratory biomarker analysis|Correlative studies
16215416|NCT01273766|Other|enzyme-linked immunosorbent assay|Correlative studies
16215417|NCT01273753|Other|Intradialytic exercise|Patients will exercise using a stationary foot pedal cycle for 20 minutes at the beginning of hemodialysis.
16215418|NCT01273740|Procedure|External support|Bypass surgery with externally supported graft
16215419|NCT01273727|Drug|Dexamethasone|intravitreal implant 0.7 mg 6 month duration
16215420|NCT01273727|Drug|dexamethasone|intravitreal implant 0.7 mg duration 6 months
16215421|NCT01273714|Procedure|thyroid resection|bilateral subtotal versus total thyroidectomy
16215422|NCT01273701|Behavioral|Psychosocial intervention|"The treatment is one-year long and composed of 3 stages of psychosocial intervention. Subjects of TSTSU arms receive urine methamphetamine examinations at each visit, while subjects in OPD arm being tested at first/last visits and during stage changes.
~-Stage 1, early intensive monitoring stage: The visit interval is 1 week. If the urine tests and self-report on methamphetamine use are negative for consecutive 4 visits, subjects can proceed to stage 2. (In OPD arm, the visit interval can be 2 weeks according to subjects' requirements.)
~-Sage 2, late intensive monitoring stage: The visit interval is 2 week. If the urine tests and self-reports are straightly negative for 4 visits, subjects can proceed to stage 3. Whenever recent methamphetamine is detected, subjects should move back to stage 1.
~-Stage 3, usual monitoring stage: The visit interval is 1 month until the end of treatment. Whenever recent methamphetamine is detected, subjects should move back to stage 1."
16215423|NCT01273701|Behavioral|Telephone reminding|Subjects in TSTSU-T group will receive addition telephone reminding one day before each visit. Each call will be no longer than five minutes. On the telephone, brief motivation enhancement may be conducted.
16215424|NCT01273688|Behavioral|Eccentric training (Flex-Bar)|6x15 repetitions of supination and pronation daily over 12 weeks
16215425|NCT01273688|Device|EpiHit elbow brace|daily wearing of the EpiHit elbow brace
16215426|NCT01273662|Drug|AG-013736|All enrolled patients will receive axitinib, 5 mg orally twice daily with food, until objective disease progression, development of unacceptable toxicity, or voluntary discontinuation by the subjects.
16215427|NCT01273649|Device|cryotherapy|cryotherapy is given with other physical training
16215428|NCT01273623|Device|Jetstream Atherectomy System|to perform atherectomy on calcified lesions
16215429|NCT01273610|Drug|Lapatinib|250 mg tablets
16215430|NCT01273610|Drug|Trastuzumab|Intravenous injection
16215431|NCT01273610|Other|laboratory biomarker analysis|
16215432|NCT01273610|Other|pharmacological study|
16215433|NCT01273584|Drug|Metformin|Maximum dosage 500 mg 2 tablets 3 times a day (with each meal) start with 1 tablet twice a day and gradually titrate upwards to maximum dose
16215434|NCT01273584|Drug|Placebo|Placebo maximum dosage 2 tablets 3 times a day ( with meals) start with 1 tablet twice a day and gradually titrate upwards to maximum dose
16215435|NCT01273571|Drug|Canagliflozin/Metformin|Two 1000-mg tablets of metformin on Day 1 followed by one 300-mg tablet of canagliflozin once daily on Days 4 through 8, followed by two 1000-mg tablets of metformin and one 300-mg tablet of canagliflozin on Day 8.
16215436|NCT01273558|Drug|Canagliflozin|One 100 mg capsule taken orally (by mouth) on Days Days 1-8
16218142|NCT01252745|Drug|13.5 mg of Testosterone, 4.5% B.I.D|
16215437|NCT01273545|Drug|PRILIGY (dapoxetine hydrochloride)|The study will observe characteristics of the patients to whom PRILIGY 30-mg and 60-mg tablets are prescribed in Germany by general practitioners and (separately) by urologists, and in Italy by urologists
16215438|NCT01273532|Drug|tapentadol (CG5503) ER 100-mg TRF|100mg TRF single oral dose
16215439|NCT01273532|Drug|tapentadol (CG5503) ER 50-mg TRF|100 mg TRF single oral dose
16215440|NCT01273506|Drug|tapentadol (CG5503) ER 25-mg TRF|50 mg TRF single oral dose
16215441|NCT01273506|Drug|tapentadol (CG5503) ER 50-mg TRF|50 mg TRF single oral dose
16215442|NCT01273493|Drug|Trabectedin|Trabectedin 0.58 or 1.3 mg/m^2 (or adjusted dose) i.v. will be administered on Day 1.
16215443|NCT01273493|Drug|Dexamethasone|Dexamethasone will be administered as 20 mg/m^2, 30 minutes prior to trabectedin.
16215444|NCT01273480|Drug|Sequence 1|Cycle 1: 2 rifampin 300 mg capsules 1x daily for 5 days followed by 2 rifampin capsules prior to trabectedin 1.3 mg/m2 i.v. on Day 1 followed 28 days later by cycle 2 trabectedin 1.3 mg/m2 i.v. on Day 1. Dexamethasone 20 mg i.v. administered prior to trabectedin in each cycle.
16215445|NCT01273480|Drug|Sequence 2|Cycle 1: Trabectedin 1.3 mg/m2 i.v. on Day 1 followed by 2 rifampin 300 mg capsules once daily on Days 24-28 followed by Cycle 2, 2 rifampin capsules prior to trabectedin 1.3 mg/m2 i.v. on Day 1 of Cycle 2. Dexamethasone 20 mg i.v. administered prior to trabectedin in each cycle.
16215446|NCT01273480|Drug|Sequence 1|Cycle 1: 2 rifampin 300 mg capsules 1x daily for 5 days followed by 2 rifampin capsules prior to trabectedin 1.3 mg/m2 i.v. on Day 1 followed 28 days later by cycle 2 trabectedin 1.3 mg/m2 i.v. on Day 1. Dexamethasone 20 mg i.v. administered prior to trabectedin in each cycle.
16215447|NCT01273480|Drug|Sequence 2|Cycle 1: Trabectedin 1.3 mg/m2 i.v. on Day 1 followed by 2 rifampin 300 mg capsules once daily on Days 24-28 followed by Cycle 2, 2 rifampin capsules prior to trabectedin 1.3 mg/m2 i.v. on Day 1 of Cycle 2. Dexamethasone 20 mg i.v. administered prior to trabectedin in each cycle.
16215448|NCT01273467|Drug|CNTO 0007 or placebo (Stage A)|a single IV infusion of a selected dose of CNTO 0007 or placebo administered IV within 1-5 days (depending on cohort) after stroke (first cohort of patients will receive the lowest dose of CNTO 0007 or placebo and each subsequent group will be administered a higher dose (to be determined)
16215449|NCT01273467|Drug|CNTO 0007 or placebo (Stage B)|a single IV infusion of the MTD of CNTO 0007 or placebo administered IV within a specified number of days after stroke
16215450|NCT01273454|Drug|OROS Hydromorphone|8,16, 32 mg once a day for 4 weeks
16215451|NCT01273441|Drug|PPI, amoxicillin, metronidazole and clarithromycin|Dual therapy for 5 days: PPI and 1g amoxicillin every 12h. After dual therapy continue with a triple therapy for 5 days: PPI, 1g amoxicillin, 500 mg metronidazole and 500 mg clarithromycin every 12h.
16215452|NCT01273441|Drug|PPI, amoxicillin, metronidazole and clarithromycin|Quadruple therapy for ten days:PPI, 1g amoxicillin, 500 mg metronidazole and 500 mg clarithromycin every 12h
16215453|NCT01273428|Drug|HP011-101|
16215454|NCT01273428|Device|HP-828-101|
16215455|NCT01273428|Other|Standard Care|
16215456|NCT01273402|Drug|TF2/IMP288|TF2 is administered 4 days prior to radiolabeled IMP288. Each are given weekly for 2 weeks.
16215457|NCT01273389|Drug|CNTO 136|Type=exact number, unit=mg/kg, number=10, form=solution for injection, route=intravenous. CNTO 136 is administered once every 4 weeks from Week 0 to Week 24.
16215458|NCT01273389|Drug|Placebo|Form=solution for injection, route=intravenous. Placebo is administered once every 4 weeks from Week 0 to Week 24.
16215459|NCT01273376|Drug|RX-10100|Extended-release tablet, taken twice daily for 8 weeks
16215460|NCT01273350|Device|Carotid PTA and stenting|Percutaneous interventional treatment of carotid artery stenosis using XACT carotid artery stent and emboshield protection system with bivalirudin as the procedural anticoagulant
16215461|NCT01273337|Biological|ALD-401|3 mL ALDHbr cells isolated from autologous bone marrow given as a one-time infusion via intracarotid infusion.
16215462|NCT01273337|Procedure|Sham Procedure|Sham bone marrow harvest and sham product infusion procedures.
16215463|NCT01273324|Device|ADM Cup|ADM Cup
16215464|NCT01273298|Drug|Bisoprolol|Patients will be assigned to bisoprolol per os or matching placebo per os daily for 14 days. Bisoprolol will be initiated at a dose of 2.5mg daily for the first two days then up-titrated to 5mg daily for two other days. And finally, bisoprolol will be up-titrated to 10mg daily for the remaining 10 days.
16215465|NCT01273298|Drug|Placebo|Patients will be assigned to bisoprolol per os or matching placebo per os daily for 14 days. Bisoprolol will be initiated at a dose of 2.5mg daily for the first two days then up-titrated to 5mg daily for two other days. And finally, bisoprolol will be up-titrated to 10mg daily for the remaining 10 days.
16215466|NCT01273285|Device|Spectralis® SD-OCT, Heidelberg Engineering GmbH, H|
16215467|NCT01273272|Behavioral|Comprehensive, CBT-based, multi-component treatment|It includes eight modules: diagnosis and goal setting; psychoeducation; engagement in pleasant activities; cognitive restructuring; live review; training caregiver in behavior man-agement techniques; interventions for the caregiver; and couples counselling. It consists of 20 weekly sessions (plus appr. 5 single session with caregiver).
16215468|NCT01273272|Behavioral|Treatment as usual|Each patient/caregiver must receive at least three out of six interventions: (1) psychoeducation on dementia and treatment of dementia (oral and written); (2) appropriate medical treatment; (3) social counseling by specialized staff; (4) memory training in group setting; (5) self-help group for the patient; (6) self-help group for the caregiver.
16215469|NCT01273259|Drug|DHEA Treatment|DHEA : 200 mg/day hard gelatine capsule
16215470|NCT01273259|Drug|DHEA Treatment|DHEA : 25 mg/day hard gelatine capsule
16215471|NCT01273246|Biological|100U inactivated Enterovirus Type 71 Vaccine|Inactivated Enterovirus Type 71 Vaccine, 100U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
16215472|NCT01273246|Biological|200U inactivated Enterovirus Type 71 Vaccine|Inactivated Enterovirus Type 71 Vaccine, 200U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
16215473|NCT01273246|Biological|400U inactivated Enterovirus Type 71 Vaccine|Inactivated Enterovirus Type 71 Vaccine, 400U per 0.5ml per dose. Vaccine will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
16215508|NCT01272960|Device|Post-Placenta Mirena Insertion|Mirena(R) intrauterine device will be inserted within 10 minutes of delivery of the placenta
16215474|NCT01273246|Biological|Placebo|Placebo, all components of the trial vacccine except for the Enterovirus Type 71 virus antigen, 0.5ml per dose. Placebo will be administered as a single 0.5 mL intramuscular injection in the deltoid muscle of the arm
16215475|NCT01273233|Biological|Inactivated Enterovirus Type 71 Vaccine|A Sinovac EV71 vaccine contains inactivated EV71 virus, aluminum hydroxide, sodium chloride, disodium hydrogen phosphate, sodium dihydrogen phosphate and injection water. The EV71 vaccine is supplied in one mono-dose vial containing 0.5 mL of viral suspension with EV71 virus antigen of 200U and 400U (Elisa unit)
16215476|NCT01273233|Other|Placebo|Placebo is suspension with a little ivory precipitation, composition of which is aluminum hydroxide diluents.
16215477|NCT01273207|Drug|Cyclosporine Inhalation Solution (CIS)|CIS is a sterile, clear, colorless, preservative-free solution of cyclosporine (USP) in propylene glycol developed specifically for administration by oral inhalation.
16215478|NCT01273181|Biological|PG13-MAGE-A3 TCR9W11 (anti-MAGE-A3/12 TCR) Transduced Autologous Peripheral Blood Lymphocytes|
16215479|NCT01273181|Drug|Aldesleukin|720,000 IU/kg every 8 hours for a maximum of 15 doses
16215480|NCT01273181|Drug|Cyclophosphamide|60 mg/kg/day x 2 days intravenous (IV)over 1 hour.
16215481|NCT01273181|Drug|Fludarabine|25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days.
16215483|NCT01273155|Drug|Belinostat|Belinostat was administered intravenously (IV) over 30 minutes on days 1 through 5 of a 21-day cycle. All patients were administered a single dose of 400 mg/m(2) of belinostat on Cycle 1 Day -7 for pharmacokinetic analysis (the total length of Cycle 1 was 28 days).
16215484|NCT01273129|Procedure|Surgical Treatment of drug resistantepilepsy|"Removal of mesial temporal sclerosis through anterior temporal lobectomy or selective amygdalohippocamp ectomy. Selective amygdalohippocamp ectomy removes the medial temporal lobe and leaves more of the surrounding normal brain than anterior temporal lobectomy.
~A non-ablative surgical, vagus nerve stimulation, uses electrodes implanted within the left carotid sheath, is an example of neuromodulation being used to treat drug resistant seizures."
16215485|NCT01273116|Other|CWS in Hospital|"Every patient aged ≥70 years will be screened for frailty. (For) every frail patient:
~will have a comprehensive (geriatric) assessment using an adapted version of the EasyCare instrument;
~a geriatric consultation team will propose/recommend a tailored care and welfare plan, which will be updated at the moment of discharge;
~will be discussed at least once in a multidisciplinary meeting;
~a structured medication review will be carried out by a geriatrician;
~is offered an activation programme by volunteers focusing on improvement of orientation, mobility, social activities or nutrition;
~may receive a consult of a geriatrician, if judged necessary;
~will receive extra attention on discharge arrangements.
~Hospital staff will be educated, disease-specific guidelines will be adapted to frail older patients."
16215486|NCT01273103|Drug|200mg [14C]- GSK2248761|single oral suspension dose of [14C]- GSK2248761 200 mg
16215487|NCT01273090|Drug|imetelstat sodium|
16215488|NCT01273090|Other|laboratory biomarker analysis|
16215489|NCT01273090|Other|pharmacological study|
16215490|NCT01273064|Drug|CTS-1027|Supplied in 30mg, 10mg, or 5mg tablets (depending on dose arm) taken twice daily for up to 48 weeks.
16215491|NCT01273064|Drug|pegylated interferon|180 micrograms in 0.5 ml of solution subcutaneously (SQ), delivered in single use syringes administered once per week, for up to 48 weeks.
16215492|NCT01273064|Drug|Ribavirin|200 mg capsules of ribavirn taken in two divided daily doses totaling 1000 mg (5 capsules) for patients weighing 75 kg or less, or 1200 mg (6 capsules) for patients weighing more than 75 kg
16215493|NCT01273064|Drug|Placebo|"Tablets identical in appearance to CTS-1027 containing inactive ingredients.
~Placebo arm patients: Two tablets taken twice daily, for a total daily dose of four tablets.
~30 mg CTS-1027 patients: One tablet taken twice daily, for a total daily dose of two tablets. One bottle of placebo is added to the 30mg kits in order to maintain the study blind (all patients recieve two-bottle kits of CTS-1027 and/or placebo)."
16215494|NCT01273051|Drug|Capecitabine|Capecitabine will be administered at a dose of 825 mg/m2 bid during radiotherapy treatment
16215495|NCT01273051|Radiation|radiotherapy|radiation 25x2 Gy
16215496|NCT01273051|Procedure|TME resection|All patients undergo a MRI of the pelvis and a rectoscopy and endorectal ultrasound 6 weeks after chemo radiation. Patients who do not respond or clinically have a T3 tumour either on visual measurements or post therapy MRI or endoanal ultrasound will be operated on with a TME resection 8 - 10 weeks after the last chemo radiation treatment.
16215497|NCT01273051|Procedure|TEM surgery|"All patients undergo a MRI of the pelvis and a rectoscopy and endorectal ultrasound 6 weeks after chemo radiation.Patients with a significant downsizing of the tumour (T0-T2) will be operated on by TEM surgery 8 -10 weeks after the last chemo radiation treatment.
~After TEM surgery, pathological assessment will dictate further treatment. Conservative treatment with careful follow-up will be performed in patients with a complete resection of a ypT0-1 rectal tumour. Patients with lymphangio invasion, an incomplete resected ypT1 (<2 mm margin), an ypT2 or ypT3 tumour after TEM will subsequently undergo TME surgery to remove the rectum within 4 weeks."
16215498|NCT01273038|Device|Morfeus|The new ostomy bag filter (called Morfeus) will be tested for a period of 14 days
16215499|NCT01273038|Device|SenSura|The CE marked ostomy bag filter will be tested for a period of 14 days
16215500|NCT01273025|Dietary Supplement|Lime powder regime|1 sachet of lime powder regimen with 200 ml of water
16215501|NCT01273012|Drug|Probiotic - Infloran|Drug:Probiotic - Infloran (TM) 1 cap (1 billion CFU of L. acidophilus and 1 billion CFU of B. bifidum) PO bid or tid
16215502|NCT01272999|Other|No intervention|Non interventional
16215503|NCT01272986|Device|ALOA IgG-Elisa|measurement of IgG Level in blood
16215504|NCT01272986|Device|ALOA IgG-AtheroAbzyme|measurement of IgG in blood
16215505|NCT01272973|Drug|semaglutide|Semaglutide (oral) administered once daily for 10 weeks.Individually adjusted dose investigated up to maximum level.
16215506|NCT01272973|Drug|placebo|Placebo (oral) administered once daily for 10 weeks.
16215509|NCT01272960|Device|Interval Insertion|Insertion of Mirena 4-8 weeks post partum after vaginal delivery
16215510|NCT01272947|Drug|Diclofenac sodium|Topical gel 1%- 4 times daily
16215511|NCT01272947|Other|Placebo|Topical gel - 4 times daily
16215512|NCT01272934|Drug|Diclofenac Sodium|Topical gel 1%-4 times daily
16215513|NCT01272934|Other|Placebo|Topical gel-4 times daily
16215514|NCT01272921|Drug|Bupivacaine|Varying doses to determine the duration of analgesia
16215515|NCT01272921|Drug|Ropivacaine|Varying doses to determine the duration of analgesia
16215516|NCT01272908|Drug|rituximab|1000 mg intravenously on Days 1 and 15
16215517|NCT01272895|Device|Coronary Intervention (GENOUS stent)|GENOUS stent (Coronary Intervention)
16215518|NCT01272882|Device|Electrical Impedance Tomography monitoring|Chest belt with 16 electrodes connected to the EIT device
16215519|NCT01272869|Device|SenSura|The ostomy bag filter will be tested for a period of 14 days
16215520|NCT01272869|Device|Morfeus|The new ostomy bag filter will be tested for a period of 14 days
16215521|NCT01272856|Drug|Abatacept|125 mg pre-filled syringe for sub-q injection weekly.
16215522|NCT01272830|Drug|Placebo|Two capsules taken twice daily with meals
16215523|NCT01272830|Drug|Apatone®B|Two capsules taken twice daily with meals
16215524|NCT01272817|Procedure|Nonmyeloablative Allogeneic Transplant|Cladribine 0.14 mg/kg/day for five days, melphalan 100 mg/m2 on one day
16215525|NCT01272817|Procedure|Nonmyeloablative Allogeneic Transplant|Total lymphoid irradiation 100cGy/day times 10 days (Monday through Friday)
16215526|NCT01272804|Drug|PF-04937319|Subjects will be dosed with PF-04937319 for 14 days. The doses planned are 10, 30, 100 and 300 mg QD. All doses will be administered as tablets (10 and 100 mg strengths). In each Cohort, 9 patients will receive PF 04937319 and 3 will receive placebo. An additional cohort of 12 patients (9 active, 3 placebo) may be performed to explore a QD or BID dose. The dose for this additional cohort could be a dose already studied or a new dose that is within the exposure stopping criteria.
16215527|NCT01272804|Drug|Placebo|Placebo to match PF-04937319 will be provided. Subjects will be dosed for 14 days. In each cohort 9 subjects will receive PF-04937319 and 3 will receive placebo.
16215528|NCT01272791|Biological|bavituximab|Patients who qualify for enrollment into the study will be randomized in a 1:1 ratio to receive study treatment of gemcitabine alone or gemcitabine with weekly 3 mg/kg bavituximab. Treatment for each patient will begin on Study Day 1. Gemcitabine (1000 mg/m2) will be given on Days 1, 8 and 15 of each 28 day cycle (4 weeks) until disease progression or unacceptable toxicities. Patients randomized to receive bavituximab will be treated weekly beginning on Day 1 of each cycle. Study visits are scheduled to occur every 7 (± 2) days for bavituximab administration (for patients randomized to receive bavituximab); gemcitabine administration will occur every 7 (± 2) days for the first 3 weeks of each 4-week cycle
16215529|NCT01272791|Drug|Gemcitabine|Gemcitabine (1000 mg/m2) will be given on Days 1, 8 and 15 of each 28 day cycle (4 weeks) until disease progression or unacceptable toxicities
16215530|NCT01272778|Drug|Lorazepam|Oral capsule, 0.2 mg, single acute dose
16215531|NCT01272778|Drug|Lorazepam|oral capsule, 0.5 mg, single acute dose
16215532|NCT01272778|Drug|Lorazepam|oral capsule, 1.0 mg, single acute dose
16215533|NCT01272778|Drug|Lorazepam|oral capsule, 2.0 mg, single acute dose
16215534|NCT01272778|Drug|Placebo|oral capsule, single acute dose
16215535|NCT01272765|Other|Placebo|Placebo
16215536|NCT01272765|Dietary Supplement|IHBG-10|500 mg IHBG-10
16215537|NCT01272752|Dietary Supplement|IHBG-10|500 mg IHBG-10
16215538|NCT01272752|Dietary Supplement|Placebo|Placebo taken 15 minutes prior to the three main meals of the day
16215539|NCT01272739|Dietary Supplement|IHBG-10|500 mg of IHBG-10 taken 15 minutes prior to the three main meals of the day
16215540|NCT01272739|Dietary Supplement|Placebo|Placebo taken 15 minutes prior to the three main meals of the day
16215541|NCT01272726|Behavioral|Education|Education on the genetics of ADHD and treatment options for ADHD
16215542|NCT01272713|Other|Oxygen therapy|"Pre-hospital supplemental oxygen administered via Hudson mask at a flow rate of 8L/min
~In-hospital oxygen as per hospital protocol"
16215543|NCT01272713|Other|No oxygen therapy|No oxygen pre-hospital or in-hospital unless the oxygen saturation falls below 94% in which case oxygen will be administered via nasal cannulae (4L/min) or Hudson mask (8L/min) and titrated to achieve oxygen saturation of 94%.
16215544|NCT01272700|Procedure|volume control|Volume controlled ventilation of tidal volume 10 ml/kg
16215545|NCT01272700|Procedure|pressure control|Pressure controlled ventilation for peak airway pressure to deliver tidal volume 10 ml/kg.
16215546|NCT01272674|Other|exercise training|4 weeks supervised physical exercise training
16215547|NCT01272661|Behavioral|Enhanced Curriculum|Brief health literacy focused modules on breastfeeding delivered in the home by Community Health Workers
16215548|NCT01272661|Behavioral|Enhanced Curriculum+Breastfeeding Doula|In the Doula Program, the Community Health Worker and mother will identify a support person (e.g. grandma, father, friend) who commits to learning about breastfeeding with the mother at home visits, and then helps her with breastfeeding postpartum.
16215549|NCT01272661|Behavioral|Enhanced Curriculum +Father Support|In the Father Support Program, mothers will give their partners father-friendly breastfeeding information and an invitation to a 3-week breastfeeding education group for fathers that includes a resource specialist or resource information for child support, re-entry and job services.
16215550|NCT01272648|Behavioral|RePCa A|"Intervention patients receives two consultations with a specialist oncology nurse three and six month after ended radiotherapy. The focus are on what is important for the patients at the specific time. The patient can bring his spouse.
~Furthermore the patients have two physiotherapy consultations with guidance in pelvic floor exercises and an individual home-program of pelvic and functional training exercises"
16215551|NCT01272635|Drug|Azithromycin|Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
16215552|NCT01272635|Drug|Prednisolone|Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day
16215553|NCT01272635|Other|Placebo Azithromycin|Suspension, 12 mg/kg once daily for 5 days, maximum dose 500mg/day
16215554|NCT01272635|Drug|Placebo Prednisolone|Syrup, 1 mg/kg/dose twice daily for 5 days, maximum dose 60mg/day
16215555|NCT01272622|Radiation|Radiation|Immediate irradiation after incomplete resection (fractionated, percutaneous irradiation, 54 gy)
16215556|NCT01272622|Other|wait and watch|wait ans watch, MRI controls, irradiation at the time of progression of residual tumor
16215557|NCT01272609|Drug|Timolol + LCP|Three sessions of LCP in 595nm (diameter of spot 7mm; duration of shooting 1,5ms; Fluence 8 J / cm ² if LCP of Candela © or 7 J / cm ² if LCP of Cynosure ©) spaced out of 1 month. Twice-daily applications on the zone treated by the LCP of timolol frost and will be begun that very evening by the first session and will be pursued 15j after the 3rd session of LCP. The maximum surface of treatment will be 100 cms ².
16215558|NCT01272609|Device|LCP|Three sessions of LCP in 595nm (diameter of spot 7mm; duration of shooting 1,5ms; Fluence 8 J / cm ²if LCP of Candela © or 7 J / cm ²if LCP of Cynosure © spaced out of 1 month.
16215559|NCT01272583|Drug|Sitagliptin|100 mg once daily for six weeks
16215560|NCT01272583|Drug|Placebo|placebo, once daily for six weeks
16215561|NCT01272557|Drug|Doxorubicin|Doxorubicin 60 mg/m2 i.v. on day 1 every 21 days Sorafenib 400 mg bid (oral) from day 3-19 every 21 days. Maximum accumulative dose of doxorubicin: 360 mg/m2 (thereafter sorafenib monotherapy continuously until progression or unacceptable toxicity).
16215562|NCT01272557|Drug|Sorafenib|Sorafenib 400 mg bid (oral) continuously
16215563|NCT01272531|Drug|Mood stabilizer treatment|lithium or valproate
16215564|NCT01272505|Procedure|converntional SILC|
16215565|NCT01272505|Procedure|Harmonic scalpel Single incision laparoscopic cholecystectomy|
16215566|NCT01272492|Other|Computer Use|Participants use the computer with the 5 modules on infant/toddler feeding/nutrition
16215567|NCT01272466|Biological|peptides derived from antiapoptotic proteins|8 Vaccinations on day 2 and 9 in every bortezomib treatment series
16215568|NCT01272427|Dietary Supplement|water with glucose|0.75 g/kg body weight of glucose added to water
16215569|NCT01272427|Dietary Supplement|water and whey protein|0.75 g/kg body weight of whey protein added to water
16215570|NCT01272427|Dietary Supplement|water with noncaloric sweetener|0.15 g of sucralose added to water
16215571|NCT01272414|Drug|Botulinum Toxin Type A|2-12 units in weekly 2u doses to effect
16215572|NCT01272414|Drug|Saline injection|Injection of 0.4cc 0.9% normal saline
16215573|NCT01272388|Drug|Tadalafil|Active drug will be encapsulated to look identical to the placebo pill. Subjects will take a single oral dose of tadalafil once daily from the time of randomization until the surgical date (~4 weeks). Subjects will begin by taking 20 mg (1 pill) daily for 3 days before having the dose increased to 40 mg (2 pills) once daily. If the increase to 40mg daily is not tolerated, then the dose will be decreased back to 20mg daily.
16215574|NCT01272388|Drug|Placebo|The placebo pill will be encapsulated to look identical to the active drug pill. Subjects will take a single oral dose of placebo once daily from the time of randomization until the surgical date (~4 weeks). Subjects will begin by taking 1 pill daily for 3 days before having the dose increased to 2 pills once daily. If the increase to 2 pills daily is not tolerated, then the dose will be decreased back to 1 pill daily.
16215575|NCT01272375|Drug|Treatment A|PF-04764793 250/50 using inhaler A
16215576|NCT01272375|Drug|Treatment B|PF-04764793 250/50 using inhaler A
16215577|NCT01272375|Drug|Treatment C|PF-04764793 250/50 using inhaler A
16215578|NCT01272375|Drug|Treatment D|PF-04764793 250/50 using inhaler A
16215579|NCT01272375|Drug|Treatment E|PF-04764793 250/50 using inhaler B
16215580|NCT01272375|Drug|Treatment F|PF-04764793 250/50 using inhaler B
16215581|NCT01272375|Drug|Treatment G|PF-04764793 250/50 using inhaler B
16215582|NCT01272362|Drug|Indacaterol|Indacaterol 150 µg once-daily via single-dose dry powder inhaler
16215583|NCT01272349|Other|Acute intermittent hypoxia|30 minutes of intermittent breathing low oxygen followed by walking on a body-weight support treadmill
16215584|NCT01272349|Other|Room air|30 minutes of breathing room air followed by walking on a body-weight support treadmill
16215585|NCT01272336|Drug|Acute Intermittent Hypoxia (AIH)|Participants will breath intermittent low oxygen via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of FIO2=0.09±0.02 (hypoxia) air for 15 minutes.Participants will receive treatment for up to seven visits.
16215586|NCT01272336|Other|SHAM-Intermittent Room Air|This is a sham intervention to the AIH intervention. Participants will breath intermittent room air via air generators. The generators will fill reservoir bags attached to a non-rebreathing face mask. Oxygen concentration will be continuously monitored to ensure delivery of FIO2=0.21±0.02 (normoxia). Participants will receive treatment for up to seven visits.
16215587|NCT01272323|Biological|Placebo|No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.
16215588|NCT01272323|Biological|Cat-PAD Dose 1|No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.
16215589|NCT01272323|Biological|Cat-PAD Dose 2|No further medication to be administered in this study. Intervention refers to treatment received in Study CP005.
16215590|NCT01272310|Biological|Hydroxychloroquine (HCQ), Pegylated Interferon Alpha-2a (Peg-IFN alpha-2a) and Ribavirin|"HCQ will be taken daily as an oral tablet of 200 mg b.i.d. Pegylated Interferon Alpha-2a - (180 µg) will be administered as weekly subcutaneous (s.c.) injections of 0.5 ml.
~Ribavirin - will be taken daily based on the patient body weight. If body weight is < 75 kg, the total daily dose of Copegus® is 1000 mg, administered as 400 mg (2 tablets of 200 mg, morning intake) and 600 mg (3 tablets of 200 mg, evening intake). If body weight is >= 75 kg, the total daily dose is 1200 mg administered as twice 600 mg (3 tablets of 200 mg per intake, morning and evening)."
16215591|NCT01272297|Device|LI-ESWT|Low intensity shock wave treatment - 12 sessions
16215592|NCT01272284|Device|Altis® Single Incision Sling System (SIS)|The Altis® SIS is a permanently implantable synthetic sling for females placed at the mid-urethra to provide a scaffold for tissue in-growth and support for stress urinary incontinence.
16215593|NCT01272258|Drug|PRO 140|SC injection
16215594|NCT01272258|Drug|Placebo|SC injection
16215595|NCT01272245|Drug|Omacetaxine|1.25 mg/m2 subcutaneously (SQ) every 12 hours (+/- 3 hours) for 3 days (Days 1-3). Each cycle will be 4-7 weeks.
16215596|NCT01272245|Drug|Cytarabine|20 mg subcutaneously every 12 hours (+/- 3 hours) for 7 days (Days 1-7). Each cycle will be 4-7 weeks.
16215597|NCT01272232|Drug|liraglutide|Liraglutide 3.0 mg for subcutaneous (under the skin) injection once daily for 56 weeks.
16215598|NCT01272232|Drug|liraglutide|Liraglutide 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.
16215599|NCT01272232|Drug|placebo|Liraglutide placebo of either 3.0 mg or 1.8 mg for subcutaneous (under the skin) injection once daily for 56 weeks.
16215600|NCT01272219|Drug|liraglutide|Subject with no pre-diabetes at screening, receiving liraglutide 3.0 mg subcutaneous (under the skin) injection once daily for 56 weeks. Subjects completing 56 weeks are re-randomised to receive liraglutide 3.0 mg for 12 weeks (until week 68).
16215601|NCT01272219|Drug|placebo|Subject with no pre-diabetes at screening, receiving liraglutide 3.0 mg subcutaneous (under the skin) injection once daily for 56 weeks. Subjects completing 56 weeks are re-randomised to receive liraglutide placebo for 12 weeks (until week 68).
16215602|NCT01272219|Drug|liraglutide|Liraglutide 3.0 mg, subcutaneous (under the skin) injection once daily for 160 weeks.
16215603|NCT01272219|Drug|placebo|Liraglutide placebo, subcutaneous (under the skin) injection once daily for 160 weeks.
16215604|NCT01272206|Drug|NNC 0128-0000-2011|Administered as one single i.v. (intravenous) injection, 100 mcg/kg
16215605|NCT01272206|Drug|NNC 0128-0000-2021|Administered as one single i.v. (intravenous) injection, 100 mcg/kg
16215606|NCT01272193|Drug|insulin degludec/insulin aspart|Injected subcutaneously (under the skin) once daily prior to the largest meal of the day as monotherapy or combined with no more than 2 oral anti-diabetic drugs (OADs).
16215607|NCT01272193|Drug|insulin glargine|Administered according to approved labelling either as monotherapy or combined with no more than 2 OADs.
16215608|NCT01272180|Biological|Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + OMV.|Two injections of a combined vaccine formulation, Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus OMV.
16215609|NCT01272180|Biological|Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV.|Two injections of Meningococcal (group B) multicomponent recombinant adsorbed vaccine plus OMV.
16215610|NCT01272180|Biological|Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.|One injection of saline solution placebo and one of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.
16215611|NCT01272180|Biological|Meningococcal (groups A, C, W, Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine + qOMV.|Two injections of a combined vaccine formulation, Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine plus a quarter dose of OMV.
16215612|NCT01272167|Behavioral|Long-term grapefruit juice consumption|The main goals of this project are (1) to characterize the effect of a long-term grapefruit juice consumption on both vascular and bone protections and (2) to assess the specific role of naringin, in these potential protective effects.
16215613|NCT01272154|Other|Transcranial magnetic stimulation|Transcranial magnetic stimulation (PAS and rTMS)
16215614|NCT01272141|Drug|Lapatinib and Everolimus|"Lapatinib: 1250 mg by mouth daily
~Everolimus: 5mg by mouth daily"
16215615|NCT01272128|Drug|Interferon beta-1a|Interferon beta-1a will not be provided as a part of this study. Participants will receive Interferon beta-1a as prescribed by their treating physician prior to enrollment.
16215616|NCT01272115|Behavioral|Integrative health care model|The integrative health care model with an empowerment approach will address the care that should be given collaboratively by the health team in cooperation with the active participation of women. The IHCM will be provided under the leadership of the nurse who will coordinate with the health team members, promote preventive care, and incorporate cognitive-behavioral strategies, such as individual and group counseling. The IHCM will be provided for three months to each woman, followed by a three-month follow-up. Each woman will receive: monthly individual counseling by nurse; eight weekly (90-minutes) group counseling sessions and 2-9 consultations with psychologist defined in accordance to women individual needs and characteristics.
16215617|NCT01272089|Drug|Olopatadine Hydrochloride Ophthalmic Solution, 0.2%|Olopatadine Hydrochloride Ophthalmic Solution, 0.2%, one drop once a day for one week
16215619|NCT01272037|Drug|Anastrozole|Given PO
16215620|NCT01272037|Drug|Exemestane|Given PO
16215621|NCT01272037|Other|Laboratory Biomarker Analysis|Correlative studies
16215622|NCT01272037|Drug|Letrozole|Given PO
16215623|NCT01272037|Other|Quality-of-Life Assessment|Ancillary studies (closed as of 12/1/12)
16215624|NCT01272037|Drug|Systemic Chemotherapy|Given IV
16215625|NCT01272037|Drug|Tamoxifen Citrate|Given PO
16215626|NCT01272024|Behavioral|Symptom Education|Participants are given a Symptom Education Toolkit at baseline and at each visit thereafter (1 month and 3 month) are encouraged to use the Toolkit for symptoms they are experiencing. They are also encouraged to use resources available to them.
16215627|NCT01272024|Behavioral|Intervention|Participants are visited/contacted by an intervention nurse ten times over a 12-week period for the purpose of helping them to manage uncertainty and distress,to boost their problem-solving skills, and to transition to treatment.
16215628|NCT01272011|Other|Intermittent Hypoxia|Individuals received exposure to intermittent hypoxia for 10 days, and placebo for 1-2 days.
16215629|NCT01272011|Other|Locomotor Training|Individuals received 10 days of locomotor training, intense walking training on a treadmill with body weight support. Manual assistance was provided at the legs to optimize stepping patterns.
16215630|NCT01271998|Drug|TR-701 FA|200 mg, oral, once daily for 3 days.
16215631|NCT01271985|Drug|PolyPill|A combination tablet containing Aspirin 81 mg, enalapril 5 mg (or valsartan 40 mg), atorvastatin 20 mg and hydrochlorothiazide 12.5 mg taken once daily
16215805|NCT01270659|Drug|Fentanyl|Fentanyl buccal tablet 100 mcg once
16215806|NCT01270659|Drug|Fentanyl|Fentanyl buccal tablet 200 mcg once
16215632|NCT01271985|Other|Minimal care|Health education pamphlet on reducing cardiovascular risk factors, direct education on reducing cardiovascular risk factors provided by the study physician and the Community Health Worker, biannual follow-up and BP measurement
16215633|NCT01271972|Drug|nesvacumab (REGN910/ SAR307746)|
16215634|NCT01271946|Device|Diagnostic catheterization procedure|Intervention includes diagnostic catheterization procedure involving access through a 5F or 6F introducer in the femoral artery.
16215635|NCT01271933|Drug|pregabalin|controlled release tablet; 165-495 mg/day; given once daily
16215636|NCT01271933|Drug|placebo|matching placebo tablet; given once daily
16215637|NCT01271920|Drug|AUY922|
16215638|NCT01271920|Drug|Trastuzumab|
16215639|NCT01271907|Drug|fludarabine|Fludarabine 25 mg/m^2 x 5 days
16215640|NCT01271907|Drug|cyclophosphamide|Cyclophosphamide 60 mg/kg intravenous (IV) x 2 days
16215641|NCT01271907|Drug|Drosophila-peptide pulsed Melanoma-reactive autologous CD8+ PBL|Up to 1x10e10 CTL-05 cells
16215642|NCT01271907|Drug|Aldesleukin|Aldesleukin 125,000 IU/kg/dose as a daily subcutaneous injection
16215643|NCT01271894|Drug|Efavirenz|600 mg once daily; given as 3 x 200 mg once
16215644|NCT01271894|Drug|Efavirenz|400 mg once daily; given as 2 x 200 mg + 1 x placebo
16215645|NCT01271881|Other|PTA alone without use of the GORE VIABAHN|PTA alone with no stent used
16215646|NCT01271881|Device|GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface|Covered stent produced by GORE VIABAHN
16215647|NCT01271868|Biological|IB1001|
16215648|NCT01271855|Drug|Belladonna and opioid suppository|Belladonna and opioid suppository 16.2mg/30mg per rectum every 8 hours for 24 hours following delivery
16215649|NCT01271855|Drug|Glycerin Suppository|A vegetable oil suppository (placebo) per rectum every 8 hours for the first 24 hours following delivery.
16215650|NCT01271829|Dietary Supplement|Avocado supplement|Calories from avocados replace calories of the control lunch
16215651|NCT01271829|Dietary Supplement|Avocado included|Calories from avocados will be added to calories from the control lunch
16215652|NCT01271803|Drug|Cobimetinib|Participants will receive cobimetinib 60 to 100 mg at any of the 3 dosing schedules with or without vemurafenib in cycles of 28 days each until disease progression, unacceptable toxicity, or any other discontinuation criteria are met.
16215653|NCT01271803|Drug|vemurafenib|Participants will receive vemurafenib 720 or 960 mg along with cobimetinib in cycles of 28 days each until disease progression, unacceptable toxicity, or any other discontinuation criteria are met.
16215654|NCT01271790|Drug|Tegobuvir (GS-9190)|Tegobuvir (GS-9190) capsule, 30 mg BID
16215655|NCT01271790|Drug|GS-9451|GS-9451 tablet, 200 mg once daily (QD)
16215656|NCT01271790|Biological|Pegasys®|peginterferon alfa-2a (solution for injection) 180 µg/week
16215657|NCT01271790|Drug|Copegus®|ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
16215658|NCT01271790|Drug|GS-9451|GS-9451 tablet, 200 mg QD
16215659|NCT01271790|Drug|Tegobuvir placebo|placebo matching Tegobuvir (GS-9190) capsule BID
16215660|NCT01271790|Biological|Pegasys®|peginterferon alfa-2a (solution for injection) 180 µg/week
16215661|NCT01271790|Drug|Copegus®|ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID)
16215662|NCT01271790|Drug|Tegobuvir placebo|placebo matching Tegobuvir (GS-9190) capsule BID
16215663|NCT01271790|Drug|GS-9451 placebo|placebo matching GS-9451 tablet QD
16215664|NCT01271790|Biological|Pegasys®|peginterferon alfa-2a (solution for injection) 180 µg/week
16215665|NCT01271790|Drug|Copegus®|ribavirin tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day ≥ 75 kg) divided twice daily (BID); tablet
16215666|NCT01271777|Drug|GFT505 80mg|hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast
16215667|NCT01271777|Drug|Placebo|hard gelatin capsules, oral administration, 4 capsules per day before breakfast
16215668|NCT01271764|Other|no drug|The role of G9a protein in patients with endometrial cancer
16215669|NCT01271751|Drug|GFT505 80mg|hard gelatin capsules dosed at 20mg, oral administration, 4 capsules per day before breakfast
16215670|NCT01271751|Drug|Placebo|hard gelatin capsules, oral administration, 4 capsules per day before breakfast
16215671|NCT01271738|Procedure|Remove tumor only|No additional margins (tissue) removed at the initial surgery
16215672|NCT01271738|Procedure|Removal of tumor and tissue|5 additional margins (tissue) removed at the time of surgery
16215673|NCT01271725|Drug|Vinorelbine 25 mg/m2 weekly|Patients to additionally receive vinorelbine at a dose of 25 mg/m2 weekly on disease progression on afatinib monotherapy
16215674|NCT01271725|Drug|Afatinib 40mg once daily (OD)|Patient to receive afatinib monotherapy at a dose of 40 mg/d until progression of their disease
16215675|NCT01271725|Drug|Paclitaxel 80 mg/m2 weekly|Patients to additionally receive paclitaxel at a dose of 80 mg/m2 weekly on disease progression on afatinib monotherapy
16215676|NCT01271712|Drug|Regorafenib (Stivarga, BAY73-4506)|160 mg po once daily (od), 3 weeks on/1 week off. Route of administration: oral
16215677|NCT01271712|Drug|Placebo|once daily (od), 3 weeks on/1 week off. Route of administration: oral
16215678|NCT01271712|Drug|Best supportive care|Best supportive care includes any method to preserve the comfort and dignity of the patients, and excludes any disease-specific anti-neoplastic therapy such as any kinase inhibitor, chemotherapy, radiation therapy, or surgical intervention.
16215679|NCT01271686|Drug|0.01% bimatoprost|0.01% bimatoprost once in the evening for 4 weeks
16215680|NCT01271660|Drug|Pregabalin|"drug form : capsule, 75/150mg. Pregabalin will be provided to treatment arm subjects for 6-week Treatment period.
~Treatment period : 75 mg twice daily during the first 1 week as titration + 150mg twice daily for 4 weeks as maintenance + 75mg twice a day as tapering"
16215681|NCT01271660|Drug|Placebo|"drug form : capsule, 75/150mg. Pregabalin will be provided to treatment arm subjects for 6-week Treatment period.
~Treatment period : 75 mg twice daily during the first 1 week as titration + 150mg twice daily for 4 weeks as maintenance + 75mg twice a day as tapering"
16215682|NCT01271647|Drug|Yin and Yang tonic granules|Yin and Yang tonic granules,18g per time,two times per day,six months
16215683|NCT01271647|Drug|placebo|granules,18g per time,two times per day,six months
16215685|NCT01271608|Device|needle exchange|Comparing the pain intensity on a numeric scale (0-10) with intramuscular and subcutaneous injection between a retractable fixed syringe needle and the technique involving needle exchange; Comparing bruise formation following administration of insulin subcutaneous injections between retractable fixed needle and the conventional technique.
16215686|NCT01271595|Other|sham acupuncture|12 sessions of sham acupuncture over 8 weeks
16215687|NCT01271582|Drug|Irinotecan, 5FU, leucovorin|FOLFIRI regimen every 2 weeks [irinotecan 150mg/m2 or 180mg/m2, leucovorin 20(200)mg/m2, 5FU 400 mg/m2 (bolus) or 2400 mg/m2 (46hour infusion)]
16215688|NCT01271569|Drug|Fospropofol disodium|Fospropofol disodium： 0.5g
16215689|NCT01271556|Drug|Salmeterol|50 mcg MDI (inhalatory), once on days A and C at t=0,
16215690|NCT01271556|Procedure|saline infusion (0.9 per cent sodium chloride)|rapid 50-minute 750-ml 0.9% saline infusion 240 minutes after inhalatory treatment on day A and B
16215691|NCT01271556|Other|Placebo|placebo, inhalatory (MDI) once
16215692|NCT01271543|Device|Endotracheal Intubation|General anesthesia will be induced with fentanyl 1-2 mcg/kg, 2-3 mg/kg propofol and maintained with 50% air /50% oxygen and isoflurane. Neuromuscular blockade will be obtained with rocuronium 0.5 mg/kg. Laryngoscopy will be performed with Shikani optical stylet (SOS) (one size) or MacIntosh laryngoscope blade size 3 for women and size 4 for men. Endotracheal intubation will be performed with an endotracheal tube of internal diameter of 7.0 mm l for female patients and 8 mm for male in both groups. Noninvasive blood pressure and heart rate will be recorded preinduction, preintubation, and every min for the first 5 min after successful intubation. The patients will be questioned post-operatively about symptoms of a sore throat, hoarseness, dysphonia or dysphagia in the Post Anesthesia Care Unit and again 24 hours after surgery.
16215693|NCT01271530|Other|Upper Limb Ergometry|Cardiovascular training will be performed using upper limb ergometers at home for 8 weeks. Each subject will receive an individually prescribed programme and will begin exercising for at least ten minutes per day three days per week. If an individual has difficulty exercising for 10 minutes continuously, the 10 minute session may be broken into 2-3 minute bursts of exercise, with one minute rests. Subjects will aim to increase exercise durations to 20 minutes per day five days per week and will exercise at moderate to high intensities.
16215694|NCT01271517|Drug|NPH insulin|Treatment twice daily with Insulatard plus Novorapid at meals. Doses adjusted according to bloodsugar
16215695|NCT01271517|Drug|Glargine|Treatment once daily with Lantus plus Novorapid at meals. Doses adjusted according to bloodsugars
16215696|NCT01271517|Drug|Detemir|Treatment twice daily with Levemir plus Novorapid at meals. Doses adjusted according to bloodsugars
16215697|NCT01271504|Drug|Sorafenib|Phase Ib: Cohort 1; 200 mg E7050 + 400 mg Sorafenib Cohort 2; 300 mg E7050 + 400 mg Sorafenib Cohort 3; 400 mg E7050 + Sorafenib
16215698|NCT01271504|Drug|Sorafenib|"E7050 given orally at 200, 300 or 400 mg once daily.
~Sorafenib given orally, 400 mg twice daily."
16215699|NCT01271478|Drug|captopril plus placebo|This group will receive captopril 50 mg/day (1 tablet of 25 mg orally twice a day) plus 1 tablet of placebo orally twice a day
16215700|NCT01271478|Drug|telmisartan plus placebo|Patients of this group will receive telmisartan 80 mg/day (1 tablet 40 mg orally twice a day) plus 1 tablet of placebo twice a day
16215701|NCT01271478|Drug|Telmisartan plus Captopril|Patients of this group will receive captopril 50 mg/day (1 tablet 25 mg orally twice a day) plus telmisartan 80 mg/day (1 tablet 40 mg orally twice a day)
16215702|NCT01271478|Drug|Placebo|Patients in this group will receive 2 tablets of placebo (starch) twice a day.
16215703|NCT01271465|Procedure|Kidney Biopsy|biopsy of transplant kidney
16215704|NCT01271452|Biological|botulinum toxin type A|20 units (total dose) botulinum toxin type A injected into glabellar region on Day 0
16215705|NCT01271452|Biological|botulinum toxin type A|30 units (total dose) botulinum toxin type A injected into glabellar region on Day 0
16215706|NCT01271439|Drug|Cetuximab|400mg/m2 intravenous infusion the week before radiotherapy, 250mg/m2 intravenous infusion weekly for 6 weeks during radiotherapy
16215707|NCT01271413|Behavioral|Computerized cognitively stimulating activities|The study will compare the effects of different methods of computerized mental stimulation. The intervention involves 25 sessions involving computerized cognitive tasks.
16215708|NCT01271387|Drug|tasimelteon|20 mg tasimelteon capsules, PO single dose
16215709|NCT01271374|Drug|amlodipine and olmesartan|Weeks 1-2: Azor® 5/20 Weeks 3-14: Azor® 10/40 Weeks 15-18: Azor® 10/40+HCTZ 25 Weeks 19-20: Azor® 10/40+HCTZ 25 + spironolactone 25 once daily
16215710|NCT01271374|Drug|losartan and HCTZ|Weeks 1-2: Hyzaar® 50/12.5 Weeks 3-14: Hyzaar® 100/25 Weeks 15-18: Azor® 10/40+HCTZ 25 Weeks 19-20: Azor® 10/40+HCTZ 25 + spironolactone 25 once daily
16215711|NCT01271361|Procedure|primary PCI with thrombectomy|thrombectomy is performed before implantation of a drug eluting stent
16215712|NCT01271361|Procedure|primary PCI without thrombectomy|no thrombectomy is performed before the implantation of a drug eluting stent
16215713|NCT01271348|Drug|Etoricoxib|Etoricoxib film tablet, 90 mg, q.d.
16215714|NCT01271348|Drug|placebo|Placebo tablet, q.d.
16215715|NCT01271335|Biological|collagenase|Lyophilized powder / sterile dosage form for single local intravascular administration via the occluded coronary.
16215716|NCT01271322|Radiation|neoadjuvant radiochemotherapy in metabolic non responders|Metabolic non-responders, with a SUV decrease of less than 35%, discontinue induction chemotherapy and proceed to an intensified radiochemotherapy treatment
16215717|NCT01271296|Dietary Supplement|Liquorice|24 gram liquorice eq. to 150 mg glycyrrhizinic acid, taken orally, for three days.
16215718|NCT01271296|Dietary Supplement|Grapefruit Juice|200 ml pink grapefruit juice three times a day, taken orally, for three days.
16215719|NCT01271283|Other|Diagnostic Laboratory Biomarker Analysis|Correlative studies
16215720|NCT01271283|Drug|Lenalidomide|Given orally
16215721|NCT01271270|Drug|Palomid 529|
16215722|NCT01271257|Drug|Misoprostol|20 microgram PO per hour for 8 doses or 80 microgram PO per 4 hours for 2 doses
16215723|NCT01271244|Drug|Escitalopram|10-20mg daily for 12 weeks
16215724|NCT01271231|Drug|Scaling and root planing plus placebo|Single session of scaling and root planing using ultrasonic device. placebo tablets 500 mg, 1 tablet every 24 hours for 3 days
16215725|NCT01271231|Drug|Scaling and root planing plus azythromycin|Single session of scaling and root planing using ultrasonic device. Azythromycin tablets 500mg. 1 tablet every 24 hours for 3 days.
16215726|NCT01271231|Drug|Prophylaxis plus azythromycin|Dental polishing using prophylaxis paste and rubber cups. Azythromycin tablets 500mg. 1 tablet every 24 hours for 3 days.
16215727|NCT01271218|Other|Diet|Participants followed isoenergetic low fat diets with higher protein (HP) or higher carbohydrate (HC) macronutrient content. Participants consumed 1,200 kcals/d for 1-week (Phase I) and 1,600 kcals/d for 9-weeks (Phase II) during a 10-week weight loss period. Participants in the HC diet consumed a diet containing 55% carbohydrate, 15% protein, and 30% fat. Subjects in the HP group consumed a diet containing 7% carbohydrate, 63% protein, and 30% fat during Phase I of the diet and 15% carbohydrate, 55% protein, and 30% fat during Phase II of the diet. The final 4-weeks of the diet (Phase III) served as a weight maintenance period in which participants consumed 2,600 kcals•d-1 consisting of 55% carbohydrate, 15% protein, and 30% fat and were instructed to follow their respective Phase I diet (1,200 kcals/d) for 2-days only if they gained 1.35 kg (3 lbs).
16215728|NCT01271218|Other|Exercise|All subjects participated in a supervised exercise program three days per week for 14-weeks. Each circuit-style workout consisted of 14 exercises (e.g. elbow flexion/extension, knee flexion/extension, shoulder press/lat pull, hip abductor/adductor, chest press/seated row, horizontal leg press, squat, abdominal crunch/back extension, pec deck, oblique, shoulder shrug/dip, hip extension, side bends and stepping). Participants performed as many repetitions in a 30-s time period. In a continuous, interval fashion, participants performed floor-based callisthenic (e.g. running/skipping in place, arm circles, etc.) exercises on recovery pads for a 30-s time period after each resistance exercise in an effort to maintain a consistent exercise heart rate that corresponded to 60% to 80% of their maximum heart rate.
16215729|NCT01271192|Procedure|surgical resection and adjuvant therapy|"Postoperative:
~Drug: fluorouracil Given IV continuously, Irinotecan Given IV Radiation: radiation therapy Given 5 days a week for 5-6 weeks"
16215730|NCT01271192|Procedure|Neoadjuvant followed by operation|"Preoperative:
~Drug: fluorouracil Given IV continuously,Irinotecan Given IV Radiation: radiation therapy Given 5 days a week for 5-6 weeks
~Postoperative:
~Drug: fluorouracil Given IV continuously,Irinotecan Given IV"
16215731|NCT01271179|Procedure|sequential perfusion with ipv Ross solution and UW solution|Totally 6 L of ipv Ross solution were initially infused (aortic: portal=1:1), followed by 2 L of cold UW solution infusion (aortic: portal=1:1).
16215732|NCT01271179|Procedure|sole perfusion with UW solution|Totally 6 L of cold UW solution were infused (aortic: portal =1:1)
16215733|NCT01271166|Drug|Imatinib, Fluorouracil, Oxaliplatin, Leucovorin and Bevacizumab|
16215734|NCT01271153|Drug|Dobutamine|Dobutamine at 5 mcg/kg/min will be administered for 2.5 hours each. Measurements will be performed at baseline (within 30 minutes before starting the infusion) and repeated within the last 30 minutes of drug infusion.
16215735|NCT01271153|Drug|Placebo|A 5% dextrose solution will be administered for 2.5 hours. Measurements will be performed at baseline (within 30 minutes before starting the infusion) and repeated within the last 30 minutes of drug infusion.
16215736|NCT01271140|Drug|Insulin|Intravenous insulin clamp at a rate of 2 mlu/kg/hr. In adition a titrating dose of 20% dextrose aiming to a blood glucose level of 4 - 5.5 mmol/l.
16215737|NCT01271127|Radiation|CT coronary angiography|patient will undergo one CT coronary angiography
16215738|NCT01271114|Drug|Hypertonic Saline and Terlipressin|Hypertonic saline 3% 7mL/Kg (with a maximum 500 mL)triggered by either Systolic Volume Variation or Pulse Pressure Variation more than 10%; Terlipressin infusion (dilution 1mg in 100mL) triggered by MAP below 70 mmHg for a goal MAP above 70 mmHg
16215739|NCT01271114|Drug|Normal saline and norepinephrine|Normal saline IV bolus 7mL/kg (with a maximum 500 mL)triggered by either Systolic Volume Variation or Pulse Pressure Variation above 10%; Norepinephrine drip (80 micrograms/mL) to keep MAP at least 70 mmHg
16215740|NCT01271088|Drug|N-acetylcysteine|N-acetylcysteine 600 mg twice a day,one week after administration of antibiotics
16215741|NCT01271075|Drug|Bilastine|Single dose, oral, 20 mg, 40 mg, 80 mg each for 7 days
16215742|NCT01271075|Drug|Bilastine|Single dose, oral, 20 mg, 40 mg, 80 mg each for 7 days
16215743|NCT01271062|Procedure|gastric bypass surgery|
16215744|NCT01271062|Procedure|abdominal surgery|
16215745|NCT01271062|Behavioral|very low caloric diet|
16215746|NCT01271049|Other|Novel Food Product|Novel food product containing essential oil blend
16215747|NCT01271049|Other|Control Food Product|Control food product
16215748|NCT01271036|Device|Formula PD-F-7716|Apply a dime-size amount on each application site as instructed during the 1-week study period
16215749|NCT01271023|Device|Control-to-Range Automated Insulin Management System|The devices that will be used in the Closed-Loop Control System are standardized across all study sites and include the DexCom Seven Plus Continuous Glucose Monitor (CGM), the OmniPod insulin pump, and the FreeStyle blood glucose meter. The Closed-Loop Control System will be used during all 3 admission visits.
16215750|NCT01271010|Drug|Cyclophosphamide|Participants received cyclophosphamide 250 mg/m^2 IV or 250 mg/m^2 orally on Days 1-3 of each cycle.
16215751|NCT01271010|Drug|Fludarabine|Participants received fludarabine 25 mg/m^2 IV or 40 mg/m^2 orally on Days 1-3 of each cycle.
16215752|NCT01271010|Drug|Rituximab|Participants received 375 mg/m^2 IV on Day 1 of Cycle 1, then 500 mg/m^2 IV on Day 1 of each subsequent cycle.
16215753|NCT01270997|Biological|Etanercept|Subcutaneous injection (SC) Etanercept 25mg twice a week for 48 weeks
16215754|NCT01270997|Biological|Etanercept|Subcutaneous injection (SC) Etanercept 25mg twice a week for 48 weeks
16215755|NCT01270984|Drug|Luckyvec 400mg film coated tablet|•400mg/tablet, PO, 1 tablet once daily for Period I & II D1(crossover)
16215756|NCT01270984|Drug|Glivec 100mg film coated tablet|•100mg/tablet, PO, 4 tablets once daily for Period I & II D1(crossover)
16215757|NCT01270971|Drug|AN2690 Topical Solution, 5%|AN2690 Topical Solution, 5%, applied once daily for 48 weeks
16215758|NCT01270971|Drug|Solution Vehicle|AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks
16215807|NCT01270659|Drug|Oxycodone/acetaminophen|Oxycodone/acetaminophen 5/325 mg once
16215808|NCT01270659|Drug|oxycodone/acetaminophen|Oxycodone/acetaminophen tablet 5/325 mg, 2 tablets one time
16215847|NCT01270373|Drug|FAC x 3 followed by Docetaxel x 3|5-Fluorouracil (500 mg/m2), Doxorubicin (50 mg/m2) and Cyclophosphamide (500 mg/m2) IV every 21 days, for 3 cycles; followed by Docetaxel 100 mg/m2 every 21 days, for 3 cycles
16216108|NCT01268423|Procedure|Percutaneous tracheostomy|Percutaneous tracheostomy within the first 4 days of mechanical ventilation.
16215759|NCT01270958|Drug|Avamys aqueous nasal spray 110mcg|"At the visit 1, subjects who fulfill the inclusion criteria are eligible to be included in the group to self-administer intranasal treatment of fluticasone furoate aqueous nasal spray 110 mcg once daily for 6 week. The subjects are instructed to administer two sprays from the device into each nostril once daily every morning. Administration of the dose will be performed by alternately spraying one spray to each nostril followed by a second spray to each nostril. Subjects will not be permitted to take any anti-allergy or rhinitis medication during the screening or treatment period.
~Throughout the study, subjects will document their study drug administration/compliance, any medical conditions experienced, and any concomitant medications taken."
16215760|NCT01270945|Drug|CV-18C3|3.75mg/kg given IV for a period of 6 weeks, followed by subcutaneous administration
16215761|NCT01270945|Procedure|Standard of Care|
16215762|NCT01270932|Drug|Lenalidomide and Dexamethasone|Lenalidomide:Daily for 21 days of a 28 day cycle Dexamethasone:Days 1-4, 9-12, 17-20 for the first cycle and then weekly dexamethasone from cycles 2-4.
16215763|NCT01270919|Device|BioDuct Meniscal Repair Device|"The BioDuct® Meniscal Repair Device is a small, cannulated, arthroscopically implanted, bioabsorbable conduit that has length sizes of 5, 7 and 9 mm. Based on the concept of trephination for treating meniscal tears in the red-white zone, the BioDuct® Meniscal Repair Device is designed to create a vascular access channel between the vascular-rich and cell-rich synovium and the meniscal tear. This channel allows for the flow of blood from the vascular to the avascular tissue to promote repair of the meniscus.
~The BioDuct® Meniscal Repair Device is not used across meniscal tears, like other fixation devices. The BioDuct® Meniscal Repair Device is used in conjunction with suturing and helps provide vascular access, while the sutures help provide fixation. Based on the Inclusion Criteria of this protocol, there can be a maximum of three BioDuct® Meniscal Repair Devices utilized for the meniscal tear."
16215764|NCT01270906|Drug|CHIR-258 (TKI258)|
16215765|NCT01270893|Drug|Nilotinib|400 mg by mouth twice a day for 7 days. Patients on Arm 2 will continue to receive Nilotinib until they have disease progression or are resectable.
16215766|NCT01270880|Drug|Hsp90 inhibitor STA-9090|Given IV
16215767|NCT01270880|Other|laboratory biomarker analysis|Correlative studies
16215768|NCT01270880|Genetic|polymerase chain reaction|Correlative studies
16215769|NCT01270880|Other|enzyme-linked immunosorbent assay|Correlative studies
16215770|NCT01270880|Genetic|RNA analysis|Correlative studies
16215771|NCT01270880|Other|spectrophotometry|Correlative studies
16215772|NCT01270880|Genetic|reverse transcriptase-polymerase chain reaction|Correlative studies
16215773|NCT01270880|Genetic|gene expression analysis|Correlative studies
16215774|NCT01270867|Device|Mechanical Thrombectomy|Each arm will use either Merci or Trevo as the primary Mechanical Thrombectomy device.
16215775|NCT01270854|Other|Plasmalyte A|Intravenous fluid
16215776|NCT01270854|Other|Normal Saline|Intravenous fluid
16215777|NCT01270841|Drug|Placebo|Placebo capsule 1x daily for 3 months
16215778|NCT01270841|Drug|topical testosterone|testosterone gel applied 1x daily for 3 months
16215779|NCT01270841|Drug|Androxal|Capsule of either 12.5 mg or 25 mg Androxal, 1x daily for 3 months
16215780|NCT01270828|Drug|Pregabalin|Tablets, 82.5 to 660mg, once per day. Duration: 19 weeks
16215781|NCT01270828|Drug|placebo|Placebo, 82.5 to 660mg, once per day. Duration: 13 weeks
16215782|NCT01270815|Drug|Pregabalin controlled release, 330 mg, 400 to 500 calories|A single oral dose of 330 mg controlled release tablet administered following a 400 to 500 calorie medium-fat lunch
16215783|NCT01270815|Drug|Pregabalin controlled release, 330 mg, 600 to 750 calories|A single oral dose of 330 mg controlled release tablet administered following a 600 to 750 calorie medium-fat lunch
16215784|NCT01270815|Drug|Pregabalin controlled release, 330 mg, 800 to 1000 calories|A single oral dose of 330 mg controlled release tablet administered following an 800 to 1000 calorie medium-fat lunch
16215785|NCT01270815|Drug|Pregabalin immediate release, 300 mg|A single oral dose of 300 mg immediate release capsule administered fasted
16215786|NCT01270802|Drug|Tenofovir/emtricitabine|Efavirenz will be switched to raltegravir 400mg orally twice daily while continuing tenofovir/emtricitabine
16215787|NCT01270802|Drug|Tenofovir/emtricitabine/efavirenz|Continued therapy with tenofovir/emtricitabine/efavirenz
16215788|NCT01270802|Drug|Raltegravir|Efavirenz will be switched to raltegravir 400mg orally twice daily while continuing tenofovir/emtricitabine
16215789|NCT01270789|Drug|Liraglutide|Liraglutide administered as once daily sc injection
16215790|NCT01270789|Drug|placebo|placebo administered as once daily sc injection
16215791|NCT01270776|Drug|2% aqueous chlorhexidine|A single application of a swabstick impregnated with the antiseptic solution over the desired area. The imparted solution will be allowed to air dry with a minimum time of 30 seconds before intervention.
16215792|NCT01270776|Drug|2% Chlorhexidine 70% isopropyl alcohol|single application of a swabstick impregnated with the antiseptic solution over the desired area. The imparted solution will be allowed to air dry with a minimum time of 30 seconds before intervention.
16215793|NCT01270763|Behavioral|Intensive lifestyle intervention|Lifestyle intervention focused on weight loss through diet and physical activity
16215794|NCT01270763|Behavioral|Diabetes support and education|Behavioral intervention focused on diabetes support and education
16215795|NCT01270750|Drug|BOSENTAN|TWICE DAILY PERORAL BOSENTAN, 125 MG DAILY DIVIDED IN TWO DOSES DURING THE FIRST MONTH AND 250 MG DAILY DIVIDED IN TWO DOSES SUBSEQUENTLY.
16215796|NCT01270737|Dietary Supplement|Whole soy (soy flour)|40g soy flour per day for six months
16215797|NCT01270737|Dietary Supplement|daidzein|66mg daidzein per day for six months
16215798|NCT01270737|Dietary Supplement|milk powder|40g low-fat dry milk per day for six months
16215799|NCT01270724|Drug|Gemcitabine, Paclitaxel and Oxaliplatin (GemPOx).|Two to four cycles of induction therapy with GemPOx followed by consolidation and ASCT.
16215800|NCT01270711|Drug|Study Drug|non interventional study - usage as per usual care
16215801|NCT01270698|Drug|IMMU-130|IMMU-130 will be administered intravenously every 2 weeks for up to 6 months or longer.
16215802|NCT01270672|Drug|3,4-Methylenedioxymethamphetamine|125 mg per os, single dose
16215803|NCT01270672|Drug|carvedilol|50 mg per os, single dose
16215804|NCT01270672|Drug|placebo|capsules identical to MDMA or carvedilol
16215809|NCT01270646|Device|Invasive mapping with CARTO3 system and Non-Invasive mapping with CardioInsight Atlas EC Mapping system|"Day 1: CRT device is implanted under general anesthesia in a conventional fashion. The coronary sinus leads will be implanted guided by the acute hemodynamic response (+(dP/dt)max) using a RADI guide wire. After device implantation, a steerable mapping catheter will be inserted in the Left Ventricle (LV) cavity to build a tridimensional activation map of the LV. This map will be obtained with and without CRT. From these maps different parameters describing LV activation will be measured and compared between patients with and without CRT.
~Day 5±2: A non-invasive map of the LV will be recorded with the CardioInsight ® system with and without CRT. The same parameters will be measured and compared with those obtained with invasive mapping."
16215810|NCT01270633|Device|PriMatrix|Following sharp debridement, application of PriMatrix dermal repair scaffold in conjunction with moist wound therapy
16215811|NCT01270633|Other|Standard of Care|Following sharp debridement, moist wound therapy
16215812|NCT01270620|Drug|propofol|comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia
16215813|NCT01270620|Drug|Desflurane|comparison of the incidence in delirium and post-operative cognitive dysfunction from propofol and desflurane in patients under general anesthesia
16215814|NCT01270607|Procedure|Acupuncture|Treatment given twice per week for 4 weeks
16215815|NCT01270594|Behavioral|COPD Inhaler Counseling|The counseling will be performed via telephone by a pharmacist at the William S Middleton Memorial Veterans Hospital. The counseling will include education about inhaled COPD medication, inhaler technique review, reminder tools, and motivational interviewing.
16215816|NCT01270594|Behavioral|Usual Pharmacy Care|The usual care arm will receive standard care from the William S Middleton Memorial Veterans Hospital pharmacists.
16215817|NCT01270581|Other|High Flow Nasal Cannula|Humidified high flow nasal cannula (HFNC) has emerged as an alternative respiratory modality for late preterm newborns with respiratory distress. Like NCPAP, oxygen is delivered to the infant via nasal prongs and provides a continuous distending pressure. Unlike the nasal prongs for NCPAP (which fit tightly in the nares), the nasal cannula for HFNC have smaller, loose-fitting prong. With HFNC, positive airway pressure is achieved by high gas flow through the cannula into the external nares which provide resistance to expiration and facilitate inspiration. The distending pressure is determined by the size and structure of the nasal cannula, gas flow rate, and the neonate's airway anatomy 4,5,7.
16215818|NCT01270581|Other|Bubble Nasal CPAP|NCPAP provides continuous distending airway pressure during inspiration and expiration via nasal prongs; this has been shown to increase lung volume by increasing alveolar size, recruiting collapsed alveoli, and preventing atelectasis. Improved lung volumes decrease V/Q mismatch and improve the clinical course of neonates with RDS, and as such, early NCPAP use often avoids the need for intubation and mechanical ventilation. Newborns receiving bubble NCPAP will be placed on a PEEP 5cm H2O, and supplemental oxygen will be provided to maintain oxygen saturation between 88-93% (standard of care group) as is standard practice. The size of the nasal prongs used will be based on the subject's weight as per the manufacturer instructions.
16215819|NCT01270568|Other|Positive Psychology|Weekly exercises focused on optimism, gratitude, altruism, and other positive affective states
16215820|NCT01270568|Behavioral|Relaxation Response|Daily practice of relaxation response, reviewed on a weekly basis
16215821|NCT01270568|Behavioral|Recollection|Subjects record daily events on a weekly basis for 8 weeks
16215822|NCT01270555|Drug|Bupropion SR|100mg capsules Initial dosing 100mgSR every morning, to be titrated to 200mgSR twice daily maximum
16215823|NCT01270542|Drug|Avastin (bevacizumab)|single 0.05 mL intravitreal injection of bevacizumab 1.25 mg
16215824|NCT01270542|Other|Sham injection|Subject's eyes will be anesthetized but no injection will be performed.
16215825|NCT01270529|Other|Increasing Physical activity|The subjects (CKD Stages 1-4, ESRD on Hemodialysis or Peritoneal Dialysis) will continue to wear the pedometer for 12 weeks during which time he or she will be asked to gradually increase steps walked per day above baseline physical activity. The patient will be called once a week in order to monitor progress, set new weekly step goals (usually 500-1000 steps/day greater than the previous week), and also to motivate the participant.
16215826|NCT01270516|Drug|HMB, hydroxymethylbutyrate|Hydroxymethylbutyrate will be given as 1500 mg powder dissolved in 30 ml saline given enterally every 12 hours for 7 days
16215827|NCT01270516|Drug|EPA, eicosapentaenoic acid|EPA given as 1000 mg solution in saline (30 ml) administered enterally every 12 hours for 7 days
16215828|NCT01270516|Drug|Saline|Control
16215829|NCT01270503|Biological|Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, Intramuscular
16215830|NCT01270503|Biological|Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, Intramuscular
16215831|NCT01270503|Biological|Menactra®: Meningococcal Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, Intramuscular
16215832|NCT01270490|Drug|Interferon-gamma, Recombinant|Interferon 50 mcg/m2 to be administered three times per week during two weeks
16215833|NCT01270477|Other|Hyperbaric oxygen treatment|Hyperbaric oxygen treatment for 2,5 hours at maximum 14 meters (standard table in Norway).
16215834|NCT01270464|Drug|Reslizumab|3.0 mg/kg or 0.3 mg/kg doses administered intravenously (iv) by qualified site personnel once every 4 weeks, for a total of 4 doses.
16215835|NCT01270464|Drug|Placebo|Placebo administered by iv infusion by qualified study personnel every 4 weeks for a total of 4 doses.
16215836|NCT01270451|Other|Lifestyle intervention to prevent weight regain|To study if subjects receiving extra guidance in diet and physical activity experience less weight gain compared to a control group.
16215837|NCT01270438|Drug|FOLFOX regimen|Given IV
16215838|NCT01270438|Drug|gamma-secretase/Notch signalling pathway inhibitor RO4929097|Given orally
16215839|NCT01270438|Biological|bevacizumab|Given IV
16215840|NCT01270438|Drug|oxaliplatin|Given IV
16215841|NCT01270438|Drug|leucovorin calcium|Given IV
16215842|NCT01270438|Drug|fluorouracil|Given IV
16215843|NCT01270412|Biological|Platelet Rich Plasma (Preparation Rich in Growth Factors)|intra articular injection 6ml
16215844|NCT01270412|Drug|Hyaluronic acid|Intra articular injections: 20 mg / 2 ml
16215845|NCT01270386|Drug|apatinib|Apatinib 750 mg p.o. once daily
16215846|NCT01270386|Drug|placebo|placebo p.o. once daily
16215848|NCT01270373|Drug|Docetaxel x 3 followed by FAC x 3|Docetaxel 100 mg/m2 IV every 21 days, for 3 cycles; followed by 5-Fluorouracil (500 mg/m2), Doxorubicin (50 mg/m2) and Cyclophosphamide (500 mg/m2) IV every 21 days, for 3 cycles
16215849|NCT01270360|Device|COLOHYBRITEST OR VALIHYBRITEST|Detection of human colon or rectal tumours by using a simplified molecular test based on either a combination of methylated DNA or protein marker(s) alone or considered together in biological fluids like blood, urine and stools
16215850|NCT01270347|Drug|MP-376 (Levofloxacin Solution for Inhalation)|MP-376 (Aeroquin, Levofloxacin solution for Inhalation) 240 mg administered BID for 28-days treatment followed by 28 days off treatment
16215851|NCT01270347|Drug|TIS (Tobramycin Inhalation Solution)|Tobramycin Inhalation Solution administered BID over 3 consecutive cycles of 28-days treatment followed by 28 days off treatment
16215852|NCT01270334|Other|PH meassurment|meassuring ph USING PROBE
16215853|NCT01270321|Drug|Everolimus|Everolimus 10 mg daily continuously (switch to 2-drug combination at progression if no intolerable toxicity)
16215854|NCT01270321|Drug|Pasireotide|Pasireotide 1200 mcg bid for 4 weeks followed by Pasireotide long acting release (LAR) 60 mg i.m. once every 4 weeks
16215855|NCT01270321|Drug|Everolimus and Pasireotide|Everolimus 10 mg daily continuously together with Pasireotide 1200 mcg bid for 4 weeks followed by Pasireotide long acting release (LAR) 60 mg i.m. once every 4 weeks
16215856|NCT01270308|Drug|Lansoprazole|Lansoprazole DR Capsules 30 mg
16215857|NCT01270282|Drug|AM-101 0.81 mg/mL|
16215858|NCT01270282|Drug|Placebo|
16215859|NCT01270269|Behavioral|Behavioral: Physical and functional rehabilitation|A multi-component program of physical rehabilitation interventions (without cognitive rehabilitation) will be delivered to patients beginning in the ICU and continue throughout the hospitalization.
16215860|NCT01270269|Behavioral|Behavioral: Cognitive, physical, & functional rehabilitation|A multi-component program of cognitive, physical, and functional rehabilitation interventions will be delivered to patients beginning in the ICU with continued cognitive rehabilitation in their home environments over a focused 12-week period.
16215861|NCT01270256|Drug|Budesonide|Pulmicort Respules at a dose of 0.25 mg. delivered intranasally via NasoNeb nebulizer once daily
16215862|NCT01270256|Drug|Placebo|Placebo delivered intranasally via NasoNeb nebulizer once daily
16215863|NCT01270230|Behavioral|Bruthas Project|The Bruthas Project HIV prevention intervention is a four-session, semi-structured individual risk reduction counseling program based on the Information-Motivation-Behavior (IMB) theoretical model. The counseling sessions are designed to complement standardized HIV-Counseling and Testing, and are delivered every 2-3 weeks over the course of 3 months. Each session lasts for approximately one hour, and is facilitated by a trained African American male counselor. The counselors engage with participants using open-ended questions and a non-judgmental, conversational style designed to elicit feedback on an individual's current level of HIV-related risk. The counselor then provides information and strengthens the participant's prevention skills.
16215864|NCT01270230|Behavioral|Standard HIV Testing and Counseling|This arm represents those receiving the standard HIV testing and counseling. We ultimately settled on the standard-of-care comparison group because our primary research question is whether the implementation of the intervention cast against the backdrop of usual care, in this case, HIV testing and counseling as mandated by the CDC, is efficacious. Thus, participants randomized to the comparison group will receive the current standard intervention which involves HIV testing, pre- and post-test counseling, plus linkage to case management. Individuals who test HIV-positive will be referred to post-test services including counseling for treatment options, HIV-positive support groups, and harm reduction workshops.
16215865|NCT01270217|Behavioral|Brief motivational interview|The brief motivational interview is a non-confrontational, patient-centered discussion between a counselor (e.g., social worker, nurse, physician, or psychologist) and an at-risk individual during which the individual's motivation and confidence to change health-related behaviors are explored.
16215866|NCT01270191|Drug|Exenatide|They will be treated with 5 mcg bid for 4 weeks and then 10 mcg bid for 12 weeks. They also visit every 2 weeks in the first 2 visits and then every month until 4 months.
16215867|NCT01270191|Drug|Humulin-N|The insulin dose will be initiated with 0.25 unit/Kg per day, and the two thirds of daily dose will be administrated before breakfast and the other will be administrated at bedtime. Insulin doses will be titrated every 3 days to achieve target fasting blood glucose values between 70 and 130 mg/dl.
16215868|NCT01270178|Drug|Entecavir|film coated tablets / 0.5mg / once daily / 3 years
16215869|NCT01270165|Drug|telbivudine|600mg, oral daily over 12 months
16215870|NCT01270152|Drug|Ascorbic Acid|comparing three different doses of ascorbic acid: 50 mg, 100 mg and 200 mg administered inside the catheter and maintained for up to 60 minutes
16215871|NCT01270139|Procedure|Transplantation of nanoparticles|60 patients into nanogroup with the use of 60/15-70/40 nm silica-gold nanoparticles (NPs) transplanted by endoscopic cardiac surgery in the composition of bioengineered on-artery patch grown on the basis of biopolymeric scaffold and host circulating CD45-CD34-CD73+CD105+ progenitor cells
16215872|NCT01270139|Procedure|Transplantation of iron-bearing nanoparticles|60 - into ferro-magnetic group with 60/15-70/40 nm silica-gold iron-bearing NPs with delivery in hand of magnetic navigation system
16215873|NCT01270139|Device|Stenting|60 - in sirolimus-eluting stenting control
16215874|NCT01270126|Device|Repetitive transorbital alternating current stimulation|Repetitive, transorbital alternating current stimulation (rtACS) was applied with a multi-channel device generating weak current pulses in predetermined firing bursts of 2 to 9 pulses. The amplitude of each current pulse was below 1000µA. Current intensity was individually adjusted according to how well patients perceived phosphenes, i.e. any sensation of flickering light in response to the rtACS stimulation.
16215875|NCT01270113|Behavioral|contingency management|
16215876|NCT01270100|Behavioral|Recovery management|
16215877|NCT01270087|Drug|Adalimumab|40 mg IV every 14 days
16215878|NCT01270074|Drug|Azithromycin|azithromycin will be given as a liquid preparation at a dose of 10 mg/kg three times per week from three months of age until three years of age
16215879|NCT01270074|Drug|Placebo control|inert liquid preparation will be given three times per week from three months of age to three years of age
16215880|NCT01270061|Behavioral|HIV testing|HIV education and counseling from a trained Research Assistant and offering of a free rapid, oral HIV test.
16218143|NCT01252745|Drug|11.25 mg of Testosterone, 4.5% T.I.D|
16215881|NCT01270061|Behavioral|General Health Screen|A video will provide health education on diabetes, hypertension, and HIV. The video will then offer free blood pressure check, blood glucose measuring, and a free, rapid oral HIV test.
16215882|NCT01270048|Drug|mild-ex-gwarip|three times a day, AC 30 min., 4 capsules taken each time (4capsules=2.5g), 8 weeks.
16215883|NCT01270048|Other|Placebo|three times a day, AC 30 min., 4 capsules taken each time (4capsules=2.5g), 8 weeks.
16215884|NCT01270035|Drug|Adalimumab|To increase the ADA dose from 40 mg eow to 80 mg eow
16215885|NCT01270022|Other|Implementation|
16215886|NCT01270022|Other|dissemination|
16215887|NCT01269996|Drug|Janumet, Lantus|"In this multicentre, randomized, open-label prospective study. Recruited patients will be randomized to one of the two treatment groups. Treatment efficacy and safety in terms of HbA1c control and hypoglycemic events will be evaluated.
~Treatment groups:
~Group 1 - Metformin followed by Sulfonylurea (Gliclazide) and supplementary intermediate-acting insulin (Protaphane) injection.
~Group 2 - Janumet followed by Lantus insulin injection."
16215888|NCT01269996|Drug|metformin, gliclazide, protaphane|"In this multicentre, randomized, open-label prospective study. Recruited patients will be randomized to one of the two treatment groups. Treatment efficacy and safety in terms of HbA1c control and hypoglycemic events will be evaluated.
~Treatment groups:
~Group 1 - Metformin followed by Sulfonylurea (Gliclazide) and supplementary intermediate-acting insulin (Protaphane) injection.
~Group 2 - Janumet followed by Lantus insulin injection."
16215889|NCT01269983|Other|Fascial Manipulation|8 treatment session in 4 weeks: every week both fascial manipulation and standard physiotherapy
16215890|NCT01269970|Other|18-FDG-PET-CT|
16215891|NCT01269931|Procedure|EBUS-TBNA|Endobronchial ultrasound with transbronchial needle aspiration (EBUS-TBNA) is a revolutionary diagnostic pulmonary procedure that allows visualization and safe, accurate biopsies of intra-thoracic structures during bronchoscopy. Patients enrolled in this study at the University of Calgary would have undergone this procedure regardless of being enrolled in this study. The purpose of the study was to prospectively compare the EBUS-TBNA performance of 2 groups of learners, performing EBUS-TBNA on patients, who had received to different methods of EBUS-TBNA training. Patients were randomly assigned to undergo bronchoscopy with a trainee from Group 1 or Group 2.
16215892|NCT01269918|Drug|Remifentanil|Remifentanil 0.08-0.15MCG/KG/MIN INFUSION THROUGHOUT PROCEDURE BASED ON HEMODYNAMICS
16215893|NCT01269918|Drug|Dexmedetomidine|a loading dose of dexmedetomidine was given at 0.5 to 1 micrograms/kg ideal body weight over 15 minutes, followed by an infusion at 0.2 to 0.7 micrograms/kg/hour.
16215894|NCT01269892|Dietary Supplement|lactose-free milk|a milk without lactose
16215895|NCT01269892|Dietary Supplement|conventional milk|a milk with lactose
16215896|NCT01269879|Device|Flexi-Bar vibration device only|daily vibration training 10min twice
16215897|NCT01269879|Device|Flexi-Bar + XCO-Trainer|"XCO-Trainer is a way to overload the cardiovascular system and the core muscles during running. An oscillating mass inside the XCO-Trainer is activated when the XCO is propelled forward and backward with force. The movement of the mass triggers a series of responses from the runners' body.
~In addition Flexi-Bar vibration training as in the referred active comparator group"
16215898|NCT01269866|Drug|Cymbalta|Cymbalta 60 to 120 mg PO QD
16215901|NCT01269827|Drug|Pentoxifylline|Over a period of 4 months, patients of the study group received one PTX tablet (400 mg) orally once a day (at dinner time)
16215902|NCT01269827|Drug|starch tablets|Over a period of 4 months, patients of the control group received one starch tablet orally once a day (at dinner time)
16215903|NCT01269814|Procedure|Gastroscopy|Gastroscopy
16215904|NCT01269801|Drug|onabotulinumtoxinA|"Group 1 will initially receive BOTOX® Cosmetic or VISTABEL® injections to the affected facial regions;
~Group 2 will initially receive JUVÉDERM® Ultra XC or JUVÉDERM® Ultra 2 (for moderate facial lines or folds) or JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions.
~At 4 weeks,Group 1 patients who initially received BOTOX® Cosmetic or VISTABEL® treatment will be crossed over and receive JUVÉDERM® treatment, and Group 2 patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment."
16215905|NCT01269801|Drug|JUVÉDERM|"Group 1 will initially receive BOTOX® Cosmetic or VISTABEL® injections to the affected facial regions;
~• Group 2 will initially receive JUVÉDERM® Ultra XC or JUVÉDERM® Ultra 2 (for moderate facial lines or folds) or JUVÉDERM® Ultra Plus XC or JUVÉDERM® Ultra 3 (for severe facial lines or folds) injections to the affected facial regions.
~At 4 weeks,Group 1 patients who initially received BOTOX® Cosmetic or VISTABEL® treatment will be crossed over and receive JUVÉDERM® treatment, and Group 2 patients who initially received JUVÉDERM® treatment will be crossed over to receive BOTOX® Cosmetic or VISTABEL® treatment."
16215906|NCT01269788|Drug|Fluoxetine|20 mg , oral , daily 30 mins before breakfast, for 6 weeks
16215907|NCT01269788|Drug|Omeprazole|20 mg , oral , daily 30 mins before breakfast, for 6 weeks
16215908|NCT01269788|Drug|placebo|oral , daily 30 mins before breakfast, for 6 weeks
16215909|NCT01269788|Drug|Omeprazole|20 mg , oral , daily 30 mins before breakfast, for 6 weeks
16215910|NCT01269788|Drug|Fluoxetine|20 mg , oral , daily 30 mins before breakfast, for 6 weeks
16215911|NCT01269788|Drug|placebo|oral , daily 30 mins before breakfast, for 6 weeks
16216031|NCT01269008|Device|Medtronic ePID 2.0|Closed loop system is an automated insulin delivery system based on body blood sugar. It consists of an Insulin pump, glucose sensor, and a device presently a laptop with all the algorithms.
16215912|NCT01269775|Other|Teaching Methods|We carried out a randomized controlled trial comparing three methods of teaching. These three instructional methods consist of face to face lecture, interactive internet based teaching and computer based teaching (lecture synchronized with presentation) regarding medical students' knowledge achievement and satisfaction.
16215913|NCT01269762|Drug|LipoCol Forte|Single dose of one, two and four 600 mg red yeast rice capsules (LipoCol Forte) Multiple dose of 600 mg red yeast rice Capsules (LipoCol Forte)twice daily for 4.5 days
16215914|NCT01269749|Radiation|RAI treatment|Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with 131I. In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs).
16215915|NCT01269749|Drug|ATD Group|Characteristics of study population. We will recruit a total of 150 patients diagnosed with GD younger than 18 years of age. All subjects are to be treated with antithyroid drugs (ATDs). In this trial, children will not be randomized to treatment, but will be treated per physician prescribed care. To ensure an equal distribution of age and gender between the two groups of children, we stratify enrollment by gender (male vs. female) and age (5-10 yrs, 10-15 yrs, 15-18 yrs).
16215916|NCT01269736|Behavioral|Education|Online ECG monitoring education program and strategies to implement and sustain change for nurses
16215917|NCT01269723|Dietary Supplement|Broccoli sprout homogenate|Subjects will drink the broccoli shake homogenate
16215918|NCT01269723|Dietary Supplement|Alfalfa sprout homogenate|Subjects will drink the alfalfa sprout homogenate.
16215919|NCT01269697|Dietary Supplement|Nutrof Total|2 capsules 2 times per day during 6 month
16215920|NCT01269697|Dietary Supplement|Placebo Nutrof total|2 capsules 2 times per day during 6 month
16215921|NCT01269684|Drug|Everolimus|Initial dose 1.5 mg b.i.d. Target blood trough level 4-10 ng/ml
16215922|NCT01269671|Drug|Melatonin, Peppermint Oil (mentharil), and Simethicone|Dosing will be dependent on patient's age during time of enrollment. Patients 8-12 years of age will receive Melatonin 3mg tab at night, Peppermint oil 1 capsule (0.2ml) 30-60 minutes prior to meal twice daily, and Simethicone 80mg tab 30-60 minutes prior to meal twice daily. Patients 13-18 years of age will receive Melatonin 3mg tab at night, Peppermint oil 2 capsules (0.4ml) 30-60 minutes prior to meal twice daily, and Simethicone tab 125mg 30-60 minutes prior to meal twice daily
16215923|NCT01269671|Other|Sugar pill|Patients in the placebo group will receive one placebo tab to be taken at night, one placebo capsule to be taken 30-60 minutes prior to meal twice daily, and one placebo tab to be taken 30-60 minutes prior to meal twice daily.
16215924|NCT01269658|Drug|Azithromycin ophthalmic solution, 1%|1 drop twice daily (BID) for the first 2 days and then 1 drop once daily (QD) for the remainder of treatment period (approximately 28 days total)
16215925|NCT01269658|Drug|Vehicle|1 drop twice daily (BID) for the first 2 days and then 1 drop once daily (QD) for the remainder of treatment period (approximately 28 days total)
16215926|NCT01269645|Behavioral|Clinical Trial educational materials|Usual care and (1) a 10-minute clinical trials educational video; and (2) a 12-page educational booklet to accompany the educational video. Content includes basic information about clinical trials and patient testimonials about the value and benefits of participating in clinical trials. The video also addresses common misperceptions about clinical trials using patient and physician testimonials. After watching the video, participants will be provided a copy of the video for home viewing, along with the educational booklet to be reviewed at home.
16215927|NCT01269632|Biological|blood sampling, specific biological exams and biobank and self administered questionnaires|"HIV INFECTION at inclusion and annually up to 06 years follow-up
~clinical and therapeutic evaluation by physician
~biological: blood sampling, specific biological exams and biobank
~self administered questionnaires
~In the physiopathological module: at inclusion and after 3 years follow up: OGTT, CT Scan, Dexa Scan, cardiovascular explorations (carotid intima media thickness, pulse wave velocity, transthoracic echocardiography)
~HIV UNINFECTED at inclusion and after 3 years follow up
~clinical evaluation by physician
~biological: blood sampling, specific biological exams and biobank
~self administered questionnaires"
16215928|NCT01269619|Device|Dynamic back support|A dynamic back support which provides pressure on the lumbar without pressure on the abdomen
16215929|NCT01269619|Device|Static back support|A standard wrap-around sacro lumbar support
16215930|NCT01269606|Drug|insulin aspart|At the first treatment visit, a single dose of insulin aspart at 0.2 U/kg via IM (in the muscle) injection is administered. At the second treatment visit, a single dose of fast-acting insulin human at 0.2 IU/kg via IM (in the muscle) injection is administered. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment visits.
16215931|NCT01269606|Drug|insulin human|At the first treatment visit, a single dose of fast-acting insulin human at 0.2 IU/kg via IM (in the muscle) injection is administered.At the second treatment visit, a single dose of insulin aspart at 0.2 U/kg via IM (in the muscle) injection is administered. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment periods.
16215932|NCT01269606|Drug|insulin aspart|At the first treatment visit, insulin aspart is intravenously infused for 24 minutes, with rate of 1.25 mU/kg/min at constant phase. At the second treatment visit, fast-acting insulin human is intravenously infused for 24 minutes, with rate of 1.25 mIU/kg/min at constant phase. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment visits.
16215933|NCT01269606|Drug|insulin human|At the first treatment visit, fast-acting insulin human is intravenously infused for 24 minutes, with rate of 1.25 mIU/kg/min at constant phase. At the second treatment visit, insulin aspart is intravenously infused for 24 minutes, with rate of 1.25 mU/kg/min at constant phase. Subjects will resume their usual insulin treatment in the wash-out period of 4-28 days between treatment periods.
16215934|NCT01269593|Drug|PET Imaging using 124 IPUH71|A dose of up to 11.0 mCi (range: 4.0-11.0 mCi) of 124I-PUH71 will be administered intravenously with the patient at rest. 124I-PUH71 scans will be performed at immediately and/or 3-4 hours, 20-24 hours, and 40-80 hours after injection of the radiotracer. Optionally, in willing patients scans will be performed 160-200 hours (~7-8 days) after injection of the radiotracer. At each time-point, a 45-60 minute axial body image is acquired. Images will be acquired on a state-of-the-art PET-CT scanner. A low-dose CT will be obtained immediately-prior to PET imaging, at each time-point. A 30-45 minute scanning timeperiod is typical for clinical PET studies.
16215935|NCT01269567|Procedure|Laying and management of the drain (strictly randomized arm with drainage)|At the end of intervention, the surgeon will position an aspiration drain in order to permit a postoperative pelvic drainage. The drain will be positioned forward sacrum, behind anastomosis. The drain will be leaved in place between 3 and 5 days. The criteria of drain ablation are the absence of haemorrhagic liquid and/or un daily debit < 100ml. Nursing care will be daily with change of bottle for collect pelvic serosity, accounting of quantity of collected liquid and realization of a dried bandage through contact with penetration of the drain.
16215936|NCT01269567|Procedure|No pelvic drainage|no aspiration drain at the end of intervention
16215937|NCT01269541|Drug|Mupirocin|Topical in the nose 3 times daily for 5 days
16215938|NCT01269541|Drug|Rifampin+Clindamycine or Trimehoprimsulfa|Rifampicin 10 mg/kgx1xVII Clindamycine 300 mgx3 Trimethoprimsulfa 400mg/80mg 2x2
16215939|NCT01269528|Other|Methacholine Challenge Test (MCT)|MCT challenge with determination of methacholine concentration that causes a 20% decrease from baseline FEV1 (forced expiratory volume in the 1st second of expiration) - PC20-FEV1 - is a well-documented method of assessing bronchial hyper-reactivity (BHR) in both adults and children. Our group has shown that the determination of PC20 by spirometry is feasible in preschool children. MCT is considered safe in this age group and our group has extensive experience with no adverse events. In the current study MCT will be performed (for the first time) in premature babies born at 30-32 weeks of gestation during 2008-2009 when they reach the age of 3-4 years (2011 and 2012, respectively). The results of MCT of the two groups will be compared.
16215940|NCT01269528|Other|Monthly telephone contact|Monthly telephone contact with the parents/caregivers will be scheduled from enrollment until the final visit at age 3-4 years. Subject illnesses and other medical events occurring during the past month will be recorded at each monthly follow-up.
16215941|NCT01269528|Other|Visits to the study site|Visits to the study site will be conducted at 6-month intervals in which physicians will record intercurrent doctor visits, emergency visits, and hospitalizations for respiratory symptoms.
16215942|NCT01269528|Other|Blood Test|For assessing IgE levels, Eosinophils count and cytokines levels
16215943|NCT01269528|Other|Fractional exhaled nitric oxide|Participant blow tidal volume for determination of exhaled NO in Exhaled breath.
16215944|NCT01269515|Drug|Etoricoxib|90 mg QD
16215945|NCT01269502|Device|"Temp Touch Diabetica Solutions inc."|Daily measurement of skin temperature on feet for one year
16215946|NCT01269502|Other|Inspection|Inspection of feet daily for one year
16215947|NCT01269476|Drug|SNX-001|3.6, 7.2, or 10.8 mg single dose or t.i.w.
16215948|NCT01269476|Drug|Placebo|Same volumes and frequency as active.
16215949|NCT01269463|Drug|Methylphenidate Hydrochloride Extended Release Capsules|Methylphenidate Hydrochloride Extended Release Capsules to be dosed once daily
16215950|NCT01269463|Drug|Placebo|Capsule without active drug
16215951|NCT01269450|Drug|micronized progesterone 200 mg (Utrogestan)|micronized progesterone 200 mg (Utrogestan, company) as an intra-vaginal tablet once daily
16215952|NCT01269450|Drug|placebo|placebo 200mg vaginal tablets
16215953|NCT01269437|Drug|Budesonide dry powder inhaler|200mcg per inhalation, twice daily, for 12 weeks
16215954|NCT01269424|Biological|MGMTP140K-encoding retroviral vector|
16215955|NCT01269424|Drug|O6-benzylguanine|
16215956|NCT01269424|Drug|temozolomide|
16215957|NCT01269424|Other|laboratory biomarker analysis|
16215958|NCT01269424|Procedure|autologous hematopoietic stem cell transplantation|
16215959|NCT01269424|Procedure|in vitro-treated peripheral blood stem cell transplantation|
16215960|NCT01269424|Radiation|radiation therapy|
16215961|NCT01269411|Drug|gamma-secretase/Notch signalling pathway inhibitor RO4929097|Given orally
16215962|NCT01269411|Procedure|therapeutic conventional surgery|Undergo surgery
16215963|NCT01269411|Other|pharmacological study|Correlative studies
16215964|NCT01269411|Other|laboratory biomarker analysis|Correlative
16215965|NCT01269398|Device|GO-LIF and SpineAssist SYSTEMS|
16215966|NCT01269385|Biological|alemtuzumab|Given subcutaneously
16215967|NCT01269385|Biological|rituximab|Given IV
16215968|NCT01269385|Drug|PGG beta-glucan|Given IV
16215969|NCT01269385|Other|flow cytometry|Correlative studies
16215970|NCT01269385|Other|laboratory biomarker analysis|Correlative studies
16215971|NCT01269385|Genetic|DNA analysis|Correlative studies
16215972|NCT01269385|Genetic|fluorescence in situ hybridization|Correlative studies
16215973|NCT01269385|Genetic|polymerase chain reaction|Correlative studies
16215974|NCT01269385|Genetic|polymorphism analysis|Correlative studies
16215975|NCT01269385|Genetic|mutation analysis|Correlative studies
16215976|NCT01269372|Device|PillCam Colon 2|"Each subject will be required to follow a bowel preparation regimen and will undergo Capsule Endoscopy (CE).
~Following capsule ingestion and depending on capsule progression through the digestive tract subjects will be required to take an additional volume of laxatives in order to enhance capsule propulsion and maintain adequate cleansing of the colon."
16215977|NCT01269372|Device|Colonoscopy|The colonoscopy procedure will be scheduled approximately 4-6 weeks after the CE procedure, and the colonoscopy bowel preparation will be the same as the bowel preparation for CE.
16215978|NCT01269359|Procedure|robotic assisted surgery|Robotic guidance: SpineAssist™ (Mazor Surgical Technologies, Caesarea, Israel), is a bone-mounted miniature robot. It is a semi-active system offering surgical tool guidance while leaving performance of the actual surgical operation, such as the drilling, in the surgeon's hands.
16215979|NCT01269346|Drug|Eribulin Mesylate|"Eribulin mesylate 1.4 mg/m2 administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.
~Trastuzumab 8 mg/kg will be administered as in IV infusion over a 90-minute period on Day 1 of Cycle 1. Thereafter, trastuzumab 6 mg/kg will be administered as an IV infusion over a 30-minute period on Day 1 of each subsequent cycle."
16215980|NCT01269333|Drug|omeprazole|omeprazole 20mg for 7 days
16215981|NCT01269333|Drug|fluvoxamine|fluvoxamine 50mg for 7 days
16215982|NCT01269333|Drug|placebo|placebo for 7 days
16215983|NCT01269320|Drug|Femarelle|Study treatment will consist of Femarelle, two 530mg oral tablets (equivalent to 322 mg of DT56a and 108 mg of Linum Usitatissimum extract each) twice a day for 90 days
16215984|NCT01269307|Procedure|1:1 ketamine-propofol mixture sedation|"Prepare Ketamine and Propofol 10mg/cc of ketamine 10mg/cc of propofol mix 1:1 in 10 or 20 cc syringes Sedation Initial dose 0.05 cc / kg IV bolus. Repeat dose 0.025 - 0.05 every 60-90 seconds as needed to reach and maintain target level of sedation.
~May round to nearest 0.5-1 cc. Note - 1 cc = 5mg of propofol and 5mg of ketamine"
16215985|NCT01269307|Procedure|Propofol Sedation|"Prepare Propofol 10mg/cc of propofol 10 or 20 cc syringes Sedation Initial dose 0.05 cc / kg IV bolus over 30 seconds. Repeat dose 0.025 - 0.05 cc/kg every 30-60 seconds as needed to reach and maintain target level of sedation.
~May round to nearest 0.5 cc Note - 1 cc = 10 mg of propofol"
16215986|NCT01269294|Drug|TMC435|2 capsules of 75 mg once daily for 7 days in Treatment A
16215987|NCT01269294|Drug|Placebo for TMC435|4 placebo capsules once daily for 7 days in Treatment C
16215988|NCT01269294|Drug|TMC435|2 capsules of 75 mg and 2 capsules of 100 mg once daily for 7 days in Treatment B
16215989|NCT01269294|Drug|Placebo for TMC435|2 placebo capsules once daily for 7 days in Treatment A
16215990|NCT01269294|Drug|Moxifloxacin|1 tablet of 400 mg on Day 7 of Treatment C
16215991|NCT01269294|Drug|Placebo for moxifloxacin|1 placebo tablet on Day 7 of Treatments A, B and D
16215992|NCT01269294|Drug|Placebo for TMC435|4 placebo capsules once daily for 7 days in Treatment D
16215993|NCT01269281|Drug|Sumatriptan|Sumatriptan Succinate Tablets 100 mg
16215994|NCT01269255|Drug|TS-1 with Cisplatin|"SP CCRT(= TS-1 with Cisplatin concurrent radiation therapy)
~Step 1: Chemotherapy; TS-1/CDDP #2 cycles
~Step 2: Chemoradiotherapy; CCRT with weekly TS-1/CDDP
~Step 3: Surgery therapy"
16215995|NCT01269242|Drug|bindarit|300 mg bid, that is one 300 mg tablet twice a day for 6 months;
16215996|NCT01269242|Drug|bindarit|600 mg bid, that is two 300 mg tablets twice a day for 6 months
16215997|NCT01269242|Drug|placebo|bindarit-matching placebo tablets for 6 months.
16215998|NCT01269229|Drug|folfox|FOLFOX: Day1- Oxaliplatin 85mg/m2, Leucovorin 200mg/m2, 5-FU 400mg/m2 IV bolus -> 2400mg/m2 46hrs continuous
16215999|NCT01269229|Radiation|short course Radiotherapy|After FOLFOX 4cycle, subject have short course RTx 5Gy at once this should be continuing for 5days so that subject should have 25Gy within 5days. Then, subjects have another 4 cycle of FOLFOX and evaluate cancer for resection.
16216000|NCT01269216|Drug|5-FU with leucovorin|5FU 400mg/m2/day with Leucovorin 20mg/m2/day IV on day 1 and day29
16216001|NCT01269216|Drug|TS-1 with Irinotecan|Irinotecan 40mg/m2/day IV on day 1,8,15,22 and 29 with TS-1 70mg/m2/day PO for 25 days
16216002|NCT01269203|Drug|Curcumin|1000 mg per day
16216003|NCT01269203|Other|Placebo|Administered daily same as Curcumin.
16216004|NCT01269190|Procedure|High-Resolution Microendoscopy|Undergo evaluation of oral lesions using a high-resolution microendoscope
16216005|NCT01269190|Procedure|Multispectral Imaging|Undergo evaluation of oral cavity using a widefield multispectral imaging
16216006|NCT01269190|Drug|Proflavine|Proflavine) used to stain the mouth tissue after initial imaging.
16216007|NCT01269177|Device|Non invasive ventilation|"Indications for the use of NIV are at least one of the following:
~Respiratory Rate ≥ 30 bpm
~PaO2/FiO2 < 200
~pH < 7.35 and PaCO2 > 45 mmH
~Contraindications for the use of NIV are at least one of the following:
~Coma
~Hemodynamic instability / shock
~Lack of compliance
~Indications for endotracheal intubation (ETI) are at least one of the following:
~Respiratory or cardiac arrest
~Coma
~Hemodynamic instability"
16216008|NCT01269164|Procedure|Surgical Procedure Composite Facial Transplant|Single Center Prospective Clinical Study to Document the Safety and Feasibility of the Surgical Procedure for Composite Facial Allograft Transplantation
16216009|NCT01269151|Drug|Lucentis (Ranibizumab)|Ranibizumab Short- and Log-term Effects on Retinal Function measured by Multifocal-ERG and Microperimetry
16216010|NCT01269138|Drug|plasma derived Factor VII|Treatment of bleeding episodes,treatment during surgery and prophylaxis
16216011|NCT01269138|Drug|recombinant FVIIa|Treatment of bleeding episodes,treatment during surgery and prophylaxis
16216012|NCT01269138|Drug|Fresh Frozen Plasma|Treatment of bleeding episodes,treatment during surgery and prophylaxis
16216013|NCT01269138|Drug|Activated Prothrombin Complex Concentrates|Treatment of bleeding episodes,treatment during surgery and prophylaxis
16216014|NCT01269138|Drug|Virus Inactivated plasma|Treatment of bleeding episodes,treatment during surgery and prophylaxis
16216015|NCT01269125|Drug|Leuprolide|single injection of 3.75 leuprolide every 28 days, 3 dosages
16216016|NCT01269125|Procedure|IVF|Assisted Reproduction Technique.
16216017|NCT01269112|Device|citrate regional anticoagulation|"Patients randomly allocated to 2 treatment groups:
~Treatment A: - Regional citrate-based anticoagulation with the Prismocitrate® 10/2 solution (GAMBRO) Treatment B: - Standard unfractionated heparin anticoagulation"
16216018|NCT01269112|Device|citrate regional anticoagulation|"Patients randomly allocated to 2 treatment groups:
~Treatment A: - Regional citrate-based anticoagulation with the Prismocitrate® 10/2 solution (GAMBRO) Treatment B: - Standard unfractionated heparin anticoagulation"
16216019|NCT01269099|Drug|IV-PCA|IV-PCA (fentanyl 10 mcg/ml) Dose bolus-lock out time - basal = 1.5 ml - 15 min - 1.5 ml/hr
16216020|NCT01269099|Drug|Control|control group (No-PCA group)
16216021|NCT01269086|Behavioral|Family Preventive Visit|Systematic assessment of health diseases or risk factors in the spouse and adolescent child.
16216022|NCT01269060|Procedure|Single Incision Laparoscopic Surgery|Single Incision Laparoscopic Sigmoidectomy
16216023|NCT01269047|Drug|Pramlintide|Start at 15 mcg capped at 60 mcg before breakfast and supper subcutaneously for 4 months
16216024|NCT01269047|Drug|Exenatide|Start at 1.25 mcg, capped at 5 mcg, subcutaneously, before breakfast and supper for 4 months
16216025|NCT01269047|Drug|Insulin|Rapid acting and long acting, subcutaneously, according to their regimen for the entire duration of the study.
16216026|NCT01269034|Drug|Exenatide|1.25 mcg before the boost sub-cutaneously.
16216027|NCT01269034|Drug|Rapid and long acting insulin|Depends on their Carbohydrate ratio and body needs
16216028|NCT01269034|Drug|long acting insulin + rapid acting + 1.25 mcg Exenatide|Depends on their body needs.
16216029|NCT01269021|Drug|mycophenolate mofetil plus lower dose of Prednisone|MMF 1.0-1.5g/d*6mons Prednisone 0.4-0.6 mg/kg/d
16216030|NCT01269021|Drug|Prednisone in full dose|0.8-1mg/kg/d
16216106|NCT01268449|Radiation|Low dose laser|5mv laser with a wavelength of 650nm
16216032|NCT01268995|Drug|Cyclosporine A|"Patients randomized into arm A will be switched from Tacrolimus to Cyclosporine A. Conversion will be done by a stop and go protocol. Patients will take their last dose Tacrolimus in the morning of the day of conversion and will start taking Cyclosporine A in the evening of the same day at a dose of 3mg/kg/d. The first measurement of Cyclosporine A trough levels will be performed 3 days after conversion and the dose will then be adjusted if necessary. Furthermore, treatment with NPH insulin once daily in the morning will be initiated."
16216033|NCT01268995|Drug|Tacrolimus|Patients in arm B will remain on their immunosuppressive therapy with Tacrolimus. Furthermore, treatment with NPH insulin once daily in the morning will be initiated.
16216034|NCT01268982|Procedure|socket preservation|sockets will be filled with DFDBA and covered with absorbable membrane. Primary coverage will be achieved by full thickness mucosal flap advancement over each socket
16216035|NCT01268969|Procedure|KARYDAKIS GROUP|The technique consisted of a vertical eccentric elliptical incision carried down to the post sacral fascia, complete removal of unhealthy tissue with the normal tissue around the cyst and sinus tracts, mobilization of the medial wound edge by undercutting the adipose tissue at a depth of 1 cm, the advancement of the flap across the midline to the post sacral fascia and suturing of its edge to the lateral one
16216036|NCT01268969|Procedure|Lamberg flap technique|The area to be excised was mapped on the skin in a rhomboid form . The skin incision was deepened to the presacral fascia centrally and to the gluteal fascia laterally. After removing the specimen, the Limberg fasciocutaneous flap was prepared by extending the incision down to and through the right gluteus maximus fascia
16216037|NCT01268943|Drug|Capecitabine|oral pills, 1000mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
16216038|NCT01268943|Drug|Capecitabine|oral pills, 1200mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
16216039|NCT01268943|Drug|Capecitabine|oral pills, 1400mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
16216040|NCT01268943|Drug|Capecitabine|oral pills, 1500mg/m2/d, split in two times, d1-14, d22-35 combined with concurrent pelvic radiation.
16216041|NCT01268930|Procedure|Bipolar electrocautery for ovarian hemostasis|after surgical excision of ovarian endometrioma with cyst wall, bipolar electrocoagulation is used to control of bleeding.
16216042|NCT01268930|Procedure|hemostatic matrix (FloSeal)|after surgical excision of ovarian endometrioma with cyst wall, hemostatic matrix is administered to the bed of cyst for 2-3 minutes to control of bleeding. Then, area is rinsed and hemostasis is checked.
16216043|NCT01268917|Drug|aspirin|aspirin 100mg daily until the surgery day
16216044|NCT01268917|Drug|aspirin|aspirin is stopped 5-7 days before operation
16216045|NCT01268904|Drug|Valproate|Intravenous valproate application to pediatric patients suffering from status epilepticus and acute repetitive seizures
16216046|NCT01268891|Drug|Placebo|Once daily; tablet; orally; 18 weeks
16216047|NCT01268891|Drug|Azilect®|1 mg daily; tablet; orally; 18 weeks
16216048|NCT01268852|Device|Damon self ligating orthodontic bracket|Orthodontic treatment with Damon self ligating bracket
16216049|NCT01268852|Device|Insignia self ligating orthodontic bracket|Orthodontic treatment with Insignia self ligating bracket
16216050|NCT01268839|Drug|TMC278|25mg tablet once daily for 28 days
16216051|NCT01268839|Drug|TMC278|25mg tablet once daily for 14 days
16216052|NCT01268839|Drug|Efavirenz|600mg tablet once daily for 14 days
16216053|NCT01268813|Other|Breath analysis and blood analysis|Exhaled breath and blood samples will be collected and further tested using Gas Chromatography-Mass Spectroscopy system.
16216054|NCT01268787|Biological|EV71 vaccine|Two-vaccination 0.25ml or 0.5ml dose assigned to two groups.
16216055|NCT01268761|Drug|GnRH antagonist (Cetrorelix)|•GnRH antagonist (Cetrorelix 0.25) during 7 days beginning administration the second day of oocyte retrieval
16216056|NCT01268761|Drug|Placebo (saline solution)|• Placebo (saline solution) 1 ampoule every 24 hours during 7 days beginning administration the second day of oocyte retrieval
16216057|NCT01268748|Procedure|Conventional laparoscopic procedure|Patients allocated to this group will undergo laparoscopic cholecystectomy using two 12 mm ports and two 5 mm ports
16216058|NCT01268748|Procedure|Experimental laparoscopic procedure|Patients allocated to this group will undergo laparoscopic cholecystectomy using only a transumbilical SILS port
16216059|NCT01268735|Drug|Lubricating eyedrops containing hydroxypropyl-guar|Eyedrops BID
16216060|NCT01268722|Device|Balloon angioplasty|This arm will include patients randomized to undergo the treatment of a chronic total occlusion of the femoropopliteal artery with the use of balloon angioplasty
16216061|NCT01268722|Device|Primary stenting|This arm will include patients randomized to undergo primary stenting of the femoropopliteal chronic total occlusion
16216062|NCT01268709|Drug|Doxepin|
16216063|NCT01268709|Drug|Nortriptyline|
16216064|NCT01268709|Drug|placebo|
16216065|NCT01268683|Drug|Glyburide for Injection|Administered as specified in the treatment arm.
16216066|NCT01268670|Drug|Ibuprofen|Subjects will receive topical LET and oral ibuprofen.
16216067|NCT01268670|Drug|Oxycodone|Subjects will receive topical LET and oral oxycodone.
16216068|NCT01268670|Other|Placebo|Subjects will receive topical LET and oral placebo.
16216069|NCT01268657|Behavioral|Education|Learning about anxiety
16216070|NCT01268657|Behavioral|Relaxation Training|Learning skills to reduce tension
16216071|NCT01268657|Behavioral|Cognitive Restructuring|Learning skills needed to cope better with distressing thoughts
16216072|NCT01268657|Behavioral|Behavioral Activation|Learning to initiate healthy activity
16216073|NCT01268657|Behavioral|Exposure|Coaching in how to confront avoided thoughts, situations, and people)
16216074|NCT01268644|Drug|Leptin|weight based sub-cutaneous injection twice daily of Leptin
16216075|NCT01268631|Drug|Duloxetine|Initial dose of 30 mg/d will be given for one week, in order to minimize possible side effects and drop outs, and then a fixed dose of 60 mg/d will be given for additional 4 weeks. The assessing person will contact patients by phone every week during the treatment period to receive the pain score for the last 24 hours, so we will have an indication of the effect among patients will discontinue medication. Patients will be asked to visit the clinic during the last week of treatment, for assessment of clinical pain (questionnaires) and pain modulation.
16216076|NCT01268631|Drug|Pregabalin|Initial dose of 75x2mg/d for one week, and then fixed dose of 150x2mg/d for the following 4 weeks. Drug should not be taken with meals. Same protocol will be applied as for Duloxetine.
16216077|NCT01268618|Dietary Supplement|Probiotic|"2 capsules, 3x/day capsules of Healthy Trinity (retail label)/Trenev Trio (professional label), for a total daily dose of:
~Lactobacillus acidophilus NAS, 30 billion CFU
~Bifidobacterium bifidum Malyoth, 120 billion CFU
~Lactobacillus delbrueckii subspecies bulgaricus LB-51, 30 billion CFU"
16216078|NCT01268618|Dietary Supplement|Placebo|2 capsules, 3x/day placebo capsules
16216079|NCT01268605|Procedure|Restoration with a dentin bonding agent (DBA)|Restoration with a dentin bonding agent (DBA) and hybrid resin-based composite: Use of a self-etch DBA Clearfil SE Bond followed by Herculite Ultra resin-based composite (Sybron/Kerr), comprising a state-of-the-art bonding and restoration system for cervical lesions.
16216080|NCT01268605|Procedure|Restoration with a resin modified glass ionomer liner (RMGI)|Restoration with a resin modified glass ionomer liner (RMGI) (Vitrebond LC, placed on the pulpal floor at a thickness of approximately 0.5 mm) followed by application of a two step self etch DBA and nanofilled resin based composite (RBC).
16216081|NCT01268592|Procedure|oocyte vitrification|freezing of the patient's retrieved oocytes via vitrification (rapid freezing)
16216082|NCT01268579|Drug|ribavirin|The clinical intervention in this study is ribavirin therapy for approximately 14 days. Ribavirin 800 mg/day is administered in divided doses, 400 mg PO qAM and 400 mg PO qPM.
16216083|NCT01268566|Drug|MEDI-575|MEDI-575 as an IV infusion.
16216084|NCT01268553|Drug|Treprostinil|Transition to inhaled treprostinil
16216085|NCT01268540|Device|FY-60AD|Phacoemulsification cataract extraction followed by implantation of an aspheric non-toric intraocular lens: Model FY-60AD.
16216086|NCT01268540|Device|NHT15, NHT30, & NHT53|Phacoemulsification cataract extraction followed by implantation of an aspheric toric intraocular lens: Model NHT15, NHT30, or NHT53.
16216087|NCT01268527|Drug|0.03% E6201|Topical 0.03% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.
16216088|NCT01268527|Drug|0.1% E6201|Topical 0.1% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.
16216089|NCT01268527|Drug|0.2% E6201|Topical 0.2% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.
16216090|NCT01268527|Drug|0.005% E6201|Topical 0.005% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.
16216091|NCT01268527|Drug|0.01% E6201|Topical 0.01% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.
16216092|NCT01268527|Drug|0.05% E6201|Topical 0.05% E6201 gel was applied once daily to individual specific regions of the psoriatic plaque.
16216093|NCT01268527|Other|Placebo - 0.03% gel vehicle|Topical 0.03% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.
16216094|NCT01268527|Other|Placebo - 0.1% gel vehicle|Topical 0.1% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.
16216095|NCT01268527|Other|Placebo - 0.2% gel vehicle|Topical 0.2% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.
16216096|NCT01268527|Other|Placebo - 0.05% gel vehicle|Topical 0.005% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.
16216097|NCT01268527|Other|Placebo - 0.01% gel vehicle|Topical 0.01% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.
16216098|NCT01268527|Other|Placebo - 0.05% gel vehicle|Topical 0.05% gel vehicle (negative control) was applied once daily to individual specific regions of the psoriatic plaque.
16216099|NCT01268527|Drug|Calcipotriene|Topical 0.005% calcipotriene (positive control) was applied once daily to individual specific regions of the psoriatic plaque.
16216100|NCT01268501|Device|Lotrafilcon B multifocal contact lens|Commercially marketed, silicone hydrogel, multifocal, soft contact lenses FDA-approved for up to 4 weeks recommended replacement schedule and up to 6 nights of extended (overnight) wear.
16216101|NCT01268488|Device|Ninja 2 Investigational Blood Glucose Meter|Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff.
16216102|NCT01268462|Other|Heliox+PEP|For the nebulization with heliox was used radioaerosol a noninvasive delivery system that consists of a nontoxic orofacial mask with two unidirectional valves - inspiratory and expiratory branch - connected to the nebulizer for radioisotopes Venticis ® II Medical device, class II, CE 0459 (Ventibox / CIS Bio International, France). This mask was attached to the patient's face to prevent leaks and maintain proper pressurization and better patient compliance to the PEP. PEP was offered to 10 cm H2O through valve (Vital Signs, Totowa, NY) attached to the expiratory branch. The nebulizer was fed by a flow of 11 l / min of heliox for the heliox group according to the protocol of Hess et al. When powered by heliox mixture, the flow was adjusted flowmeter suitable for this mixture.
16216103|NCT01268462|Other|Oxygen+PEP|For nebulization of radioaerosol with oxygen, we used a noninvasive delivery system that consists of a mask with two nontoxic orofacial unidirectional valves - inspiratory and expiratory branch - connected to the nebulizer for radioisotopes Venticis ® II Medical device, class II, CE 0459 (Ventibox / CIS Bio International, France). This mask was attached to the patient's face to prevent leaks and maintain proper pressurization and better patient compliance to PEP (Figure 2). PEP was offered to 10 cm H2O through valve (Vital Signs, Totowa, NY) attached to the expiratory branch. The nebulizer was fed by a stream of 8 l / min oxygen.
16216104|NCT01268462|Other|Heliox|For the nebulization with heliox we used a noninvasive delivery system that consists of a nontoxic orofacial mask with two unidirectional valves - inspiratory and expiratory branch - connected to the nebulizer for radioisotopes Venticis ® II Medical device, class II, CE 0459 (Ventibox / CIS Bio International, France). We used a PEP valve without resistance.
16216105|NCT01268462|Other|Oxygen|For nebulization of radioaerosol with oxygen, we used a noninvasive delivery system that consists of a mask with two nontoxic orofacial unidirectional valves - inspiratory and expiratory branch - connected to the nebulizer for radioisotopes Venticis ® II Medical device, class II, CE 0459 (Ventibox / CIS Bio International, France). We used a PEP valve without resistance.
16218363|NCT01251159|Genetic|polymerase chain reaction|
16216109|NCT01268423|Procedure|Prolonged translaryngeal intubation|Prolonged endotracheal intubation, and reevaluation at day 10 to establish the requirement of percutaneous tracheostomy. If clinical condition determines that the patient needs a percutaneous tracheostomy, this will be performed between days 11 and 14.
16216110|NCT01268397|Procedure|open reduction and internal fixation with a volar plate|flexor carpi radialis approach, open reduction, fixed-angle volar plate, plaster cast 2 weeks at the surgeon's discretion
16216111|NCT01268397|Procedure|closed reduction and plaster treatment|closed reduction, below elbow plaster cast, semicircular for 5 week
16216112|NCT01268384|Drug|Gemcitabine plus Capecitabine|Gemcitabine 1,250 mg/m2 mixed with 0.9% saline 500 ml i.v. for 10 mg/m2/min on D1 and D8 Capecitabine 950 mg/m2 b.i.d. po from D1 to D14 every 21 days
16216113|NCT01268371|Device|Promus Element, Boston Scientific Corporation|Everolimus-eluting stent
16216114|NCT01268371|Device|Nobori, Terumo Corporation (Japan)|Biolimus-eluting stent with biodegradable polymer
16216115|NCT01268358|Drug|Lamazym|Lamazym, ERT, infusion weekly
16216116|NCT01268345|Device|blood glucose monitor|Blood glucose monitor is used to monitor the blood glucose level of the human-being
16216117|NCT01268345|Device|blood glucose monitor|Blood glucose monitor is used to monitor the blood glucose level of the human-being.
16216118|NCT01268332|Drug|Non-medicated Intravaginal Ring|Cured silicone elastomer composed of an elastomer base, normal propylorthosilicate, and titanium dioxide. The ring will not contain an active pharmaceutical ingredient.
16216119|NCT01268319|Device|Embolic Protection Device (EPD)|"The embolic protection device consists of a protection wire, a delivery sheath, a retrieval sheath and various accessories (wire torque device, introducer, dilator tool). The wire of the EPD is used as a standard 0.014 steerable guide wire. The filter is designed for embolic debris capture while maintaining continuous blood flow. At the completion of the procedure, the filter and its contents are removed using the retrieval sheath and then removed from the patient."
16216120|NCT01268319|Device|Intracoronary Spectroscopy and Ultrasonic Evaluation|This intervention requires a near infrared imaging catheter equipped with an intravascular ultrasonic transducer be used to evaluate the coronary artery wall prior to treatment and after treatment. This system detects the lipid containing plaques that may be the source of embolic debris released during standard angioplasty and stent placement.
16216121|NCT01268319|Device|Angioplasty and Stent Implant|The target plaque will be treated with a pre-dilation with a standard angioplasty balloon sized to within 0.5mm of the diameter of the reference vessel diameter. The physician will then implant a coronary artery stent that is appropriately sized for the reference vessel diameter.
16216122|NCT01268306|Device|B+L Biotrue MPS and B+L PureVision|Subjects use Bausch & Lomb (B+L) Biotrue MPS with B+L PureVision contact lenses
16216123|NCT01268293|Drug|E7080|This arm will be a dose-escalation evaluation of 9-18 subjects to investigate the tolerability and safety of E7080 up to 24 mg when administered orally on a once daily continuous dose schedule in cycles (4 weeks as 1 cycle). Administration of the study drug can continue until subjects meet discontinuation criteria such as disease progression, intolerable toxicity, and withdrawal of study consent.
16216124|NCT01268280|Drug|Placebo|Matching placebo in capsules administered as a single oral dose.
16216125|NCT01268280|Drug|250 mg CK-2017357|250 mg CK-2017357 in capsules administered as a single oral dose.
16216126|NCT01268280|Drug|500 mg CK-2017357|500 mg CK-2017357 in capsules administered as a single oral dose.
16216127|NCT01268267|Device|Ninja 2 Investigational Blood Glucose Monitoring System|Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter and an investigational sensor. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff.
16216128|NCT01268215|Drug|Infasurf|Endotracheal instillation of Infasurf once per week for three weeks
16216129|NCT01268215|Drug|Pulmicort|Endotracheal instillation, once per week for three weeks
16216130|NCT01268215|Other|Sham|None instilled through the endotracheal tube
16216131|NCT01268202|Drug|Pravastatin|Pravastatin 40mg/day during 12 months
16216132|NCT01268189|Device|Oxygen diffusing dressing|Oxygen diffusing dressing applied to study wound
16216133|NCT01268189|Device|Standard of care dressing|Xeroform control dressing applied to control wound
16216134|NCT01268176|Dietary Supplement|cholecalciferol|50,000 IU once per month for 3 months
16216135|NCT01268163|Drug|European Taxotere®|60-100 mg/m^2 IV
16216136|NCT01268163|Drug|American Taxotere®|60-100 mg/m^2 IV
16216137|NCT01268163|Drug|Hospira Docetaxel Injection|60-100 mg/m^2 IV
16216138|NCT01268150|Drug|Eribulin mesylate|Eribulin mesylate 1.4 mg/m2 will be administered as an intravenous (IV) infusion (over 2 to 5 minutes) on Days 1 and 8 of each 3-week cycle.
16216139|NCT01268137|Procedure|Deep Brain Stimulation|Surgical electrode implantation in the white matter adjacent to the Cg25 region and implantation of the DBS pulse generating device
16216140|NCT01268124|Drug|HTC-867|
16216141|NCT01268111|Drug|Ergocalciferols|ERgocaclciferol 50,000 units weekly for 8 weeks
16216142|NCT01268111|Drug|Placebo|matching placebo
16216143|NCT01268098|Drug|NPSP558|All patients will inject NPSP558 25 or 50 µg SC QD into alternating thighs in the morning via a multidose injection pen device.
16216144|NCT01268085|Other|Radiation Alert|A radiation safety pop-up alert with a message about the dangers of cumulative ionizing radiation, the patient's cumulative CAT scan history, and the most recent imaging test from any modality of the same body part
16216145|NCT01268085|Other|Control|Control with no inverention
16216146|NCT01268059|Drug|Carboplatin|Carboplatin (carboplatin area under the plasma concentration-time curve [AUC] of 6 milligram per milliliter into minute [mg/mL*min] administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
16216147|NCT01268059|Drug|Paclitaxel|Paclitaxel 200 milligram per square meter (mg/m^2) administered as an intravenous (IV) infusion once every 21 days on Day 1, for a total of 6 doses (cycles) until unacceptable toxicity, disease progression, or other reasons for participant withdrawal.
16216202|NCT01267734|Drug|Double-dose clopidogrel anti-platelet therapy (DDAT)|100mg Aspirin QD + 150mg Clopidogrel QD for 1 month
16216148|NCT01268059|Drug|MEDI-575|MEDI-575 at a dose of 25 milligram per kilogram (mg/kg) administered as an IV infusion once every 21 days on Day 1 for a total of 6 cycles until unacceptable toxicity, disease progression, initiation of alternative anticancer therapy, or other reasons for participant withdrawal. MEDI-575 alone continued in those participants who achieved stable disease or better at the completion of carboplatin/paclitaxel therapy and did not demonstrate toxicity to MEDI-575.
16216149|NCT01268046|Drug|Estradiol oral capsule|1 oral capsule (1 mg estradiol) administered daily for one month
16216150|NCT01268046|Drug|transderman estrogen patch|transdermal estrogen patch (50 mcg/day) for one month
16216151|NCT01268046|Drug|trasdermal placebo patch|transdermal placebo patch with patch change every 84 hr for one month
16216152|NCT01268046|Drug|placebo oral capsule|placebo oral capsule administered daily for one month.
16216153|NCT01268033|Drug|Rituximab|two infusions - at the dose of 375 mg/m²- will be administered at one week of interval
16216154|NCT01268033|Drug|Placebo|two infusions - at the dose of 375 mg/m² - will be administrered at one week of interval
16216155|NCT01268020|Drug|[18F]-FMH3|Subjects will be injected with up to 5 mCi and not to exceed 5.5mCi (not >10% of 5 mCi limit) or 2 ug of [18F]-FMH3, whichever is greatest.
16216156|NCT01267994|Drug|Anakinra|100mg of anakinra administered by a subcutaneous injection for 84 consecutive days.
16216157|NCT01267981|Drug|Standard diet|"After the lunch the day before the exploration, drink only clear liquids and stop solid food.
~From 10 pm, stay fasting, don't drink except the usual drugs taken with mouthful of water until the exploration by video-capsule endoscopy."
16216158|NCT01267981|Drug|Standard Diet + 500 ml of polyethyleneglycol|Apply the standard diet and drink 500 ml of polyethylene glycol 30 minutes after the endoscopy video-capsule ingestion.
16216159|NCT01267981|Drug|Standard diet + 2 liters of polyethylene glycol the day before + 500ml of polyethylene glycol|apply the standard diet and drink 2 liters of polyethylene glycol between 19h and 21h the day before exploration. Then drink 500 ml of polyethylene glycol 30 minutes after the endoscopy video-capsule ingestion.
16216160|NCT01267968|Drug|GSK2251052|1500 mg (dosing detailed in Arm description)
16216161|NCT01267955|Other|Laboratory Biomarker Analysis|Correlative studies
16216162|NCT01267955|Other|Pharmacogenomic Study|Correlative studies
16216163|NCT01267955|Drug|Vismodegib|Given PO
16216164|NCT01267942|Drug|Enhancin|"Intravenous Enhancin at induction at a dose of 25 mg/kg amoxycillin equivalent.
~Oral dose of the same at the same dosage for the active comparator arm."
16216165|NCT01267929|Procedure|The mirror neurons stimulation based VCD program|The children receive the mirror neurons stimulation based VCD program and practice at home three times a day for six months.
16216166|NCT01267929|Procedure|The conventional physical therapy|The children were randomly assigned to receive the conventional physical therapy for six months. Both experimental and control groups were measured their motor functions with GMFM-66 by an independent pediatric physical therapist who was blinded for treatment allocation at entry, the second month and the sixth month.
16216167|NCT01267916|Device|RR 6 + 0|Respiratory rate 6 Tidal volume 16.7 ml/kg external PEEP = 0
16216168|NCT01267916|Device|RR 10 + 0|Respiratory rate 10 Tidal volume 10 ml/kg external PEEP = 0
16216169|NCT01267916|Device|RR 16 + 0|Respiratory rate 16 Tidal volume 6.25 ml/kg external PEEP = 0
16216170|NCT01267916|Device|RR 6 + 5|Respiratory rate 6 Tidal volume 16.7 ml/kg external PEEP = 5
16216171|NCT01267916|Device|RR 10 + 5|Respiratory rate 10 Tidal volume 10 ml/kg external PEEP = 5
16216172|NCT01267916|Device|RR 16 + 5|Respiratory rate 16 Tidal volume 6.25 ml/kg external PEEP = 5
16216173|NCT01267903|Biological|vaccine against EV71 of 320U/0.5ml|inactivated vaccine(vero cell) against EV71 of 320U/0.5ml on day0,28,modern medicines
16216174|NCT01267903|Biological|vaccine against EV71 of 640U/0.5ml|inactivated vaccine(vero cell) against EV71 of 640U/0.5ml on day0,28
16216175|NCT01267903|Biological|vaccine against EV71 of 160U/0.5ml|inactivated vaccine(vero cell) against EV71 of 160U/0.5ml on 0,28 day
16216176|NCT01267903|Biological|vaccine against EV71 of 320U/0.5ml|inactivated vaccine(vero cell) against EV71 of 320U/0.5ml on day0,28
16216177|NCT01267903|Biological|vaccine against EV71 of 640U/0.5ml|inactivated vaccine(vero cell) against EV71 of 640U/0.5ml on day0,28
16216178|NCT01267877|Other|read unfavorable article prior to answering questions|"article title: Taking a hit on healthcare- why that's women's work"
16216179|NCT01267877|Other|read favorable article prior to answering questions|"read A Backlash of Mistrust"
16216180|NCT01267864|Drug|Metoclopramide|10mg IVSS
16216181|NCT01267864|Drug|Ketorolac|30g IVSS
16216182|NCT01267864|Drug|Valproate|1gm IVSS
16216183|NCT01267838|Procedure|PCI|PCI of bifurcation lesions with double stenting
16216184|NCT01267825|Drug|CT-guided corticosteroid+ bupivicaine|CT-guided corticosteroid+ bupivicaine Also get standard medical care
16216185|NCT01267825|Drug|Standard medical care|Naproxen + Oxycodone/ Acetaminophen
16216186|NCT01267812|Drug|bortezomib|Given SC or IV
16216187|NCT01267812|Biological|rituximab|Given IV
16216188|NCT01267812|Other|laboratory biomarker analysis|Correlative studies
16216189|NCT01267812|Other|immunohistochemistry staining method|Correlative studies
16216190|NCT01267812|Genetic|RNA analysis|Correlative studies
16216191|NCT01267812|Genetic|gene expression analysis|Correlative studies
16216192|NCT01267812|Genetic|DNA analysis|Correlative studies
16216193|NCT01267812|Other|pharmacological study|Correlative studies
16216194|NCT01267812|Other|pharmacogenomic studies|Correlative studies
16216195|NCT01267812|Other|Questionnaire Administration|
16216196|NCT01267786|Procedure|Liver surgery|hepatectomy
16216197|NCT01267773|Behavioral|Integrated Treatment|
16216198|NCT01267760|Device|Multipass hemodialysis|8-hour dialysis using a recycled dialysis bath of 25-30 l
16216199|NCT01267734|Device|Everolimus-eluting coronary stenting system (EECSS, Promus Element)|Everolimus-eluting stent
16216200|NCT01267734|Device|Zotarolimus-eluting coronary stenting system (ZECSS, Endeavor Resolute)|Zotarolimus-eluting stent
16216201|NCT01267734|Drug|Triple anti-platelet therapy (TAT)|100mg Aspirin QD + 75mg Clopidogrel QD + 100mg Cilostazol BID for 1 month
16216203|NCT01267721|Procedure|Blood sampling|Blood sampling at various time points. Additional 92 mL blood.
16216204|NCT01267695|Drug|imatinib mesylate|Patients receive oral imatinib mesylate once daily for 6 months in the absence of disease progression or unacceptable toxicity. Patients with disease progression or unacceptable toxicity are considered for immediate surgical resection. Within 2-6 weeks after completion of imatinib mesylate, patients with responding or stable disease undergo surgical resection. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for one and a half years.
16216205|NCT01267695|Procedure|conventional surgery|All the patients should receive elective surgery with R0 resection.
16216206|NCT01267682|Behavioral|Cognitive Stimulation|Thirty minutes of cognitive stimulation delivered daily for thirty minutes.
16216207|NCT01267669|Drug|Somatostatin|Emergency EVL plus Somatostatin (250 mcg/hr) infusion for 5 days
16216208|NCT01267669|Drug|Placebo|Emergency EVL plus placebo infusion for 5 days
16216209|NCT01267656|Device|Lubricating and Rewetting Drops|Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.
16216210|NCT01267656|Device|AMO Blink Contacts Lubricant Eye Drops|Instill 1-2 rewetting drops in each eye at least QID (4 times per day) for one week.
16216211|NCT01267643|Drug|Alefacept|"Dose Escalation Schedule
~Level -1 5 mg IV once weekly
~Level 1 7.5 mg IV once weekly
~Level 2 10 mg IV once weekly
~Level 3 12.5 mg IV once weekly"
16216212|NCT01267604|Drug|Recombinant FSH (rFSH)|225IU
16216213|NCT01267604|Dietary Supplement|rFSH + Inositol + Melatonin|225IU rFSH, 4g Inositol, 3mg Melatonin
16216214|NCT01267578|Biological|vaccination|Biological/Vaccine: URLC10, CDCA1, and KOC1 peptides
16216215|NCT01267565|Other|dosage of amylase|4 sets of aspirations on one day per inclusion in the intubated and ventilated patients group and 1 set of aspiration in the non intubated patients group
16216216|NCT01267552|Procedure|Non drains will be placed during operation|Non drains will be placed during operation
16216217|NCT01267552|Procedure|Closed suction drainage|Closed suction drainage will be placed during operation
16216218|NCT01267526|Device|Easypod™|Saizen (Somatotropin) administered by easypod™ as defined in SAIZEN® Canadian Product Monograph
16216219|NCT01267500|Procedure|Non surgical therapy|patching or fusion exercises
16216220|NCT01267487|Drug|Heparin fixed doses|"Fixed doses of 400 units/ kg of patient's body weight before CPB to achieve an ACT > 480 sec. Supplemental doses of 50mg of heparin if ACT <480 sec during CPB.
~Reversal doses of protamine in a 1:1 ratio (1mg of protamine for every mg of heparin administered), plus 0.8mg/kg of protamine at the end of the surgery."
16216221|NCT01267487|Drug|PO continuous infusion of Protamine|25mg/hour in IV continuous infusion during first 6 PO hours
16216222|NCT01267487|Drug|Heparin and protamine titration|"Titrated doses of heparin during CPB were manually calculated using Bull´s dose-response curve, which was based in periodic assessment of Activated-Coagulation Times (ACT)- baseline ACT, after 2mg/kg of heparin at cannulation and every 15 to 30 minutes during CPB.
~Reversal doses of protamine were calculated as a 1:1 ratio of the actual estimated heparin concentration (in mg/kg) at the end of CPB, using the Bull´s dose response curve."
16216223|NCT01267474|Other|Nutritional education|"A nutritional education program was carried out during seven months of one school year aiming to reduce added sugar in school meals by the school lunch cooks and in their own consumption.
~All women in the intervention group participated in three sections about sugar consumption and one section on food labeling, as well as recipes competition of with reducing sugar.
~Printed material and gifts, such as mugs, refrigerator magnets and small purses with the logo of the campaign were given to the participants.
~All sections of education were delivered in the schools. The activities required 20 to 30 minutes and were facilitated by trained research assistants. Printed instructions and orientations on the facilitation process supported the assistants' efforts."
16216224|NCT01267474|Other|Control|The control group received only three one-hour general sessions on health issues.
16216225|NCT01267461|Other|Tissue sample from tumor|Endometrial cancer specimens will be obtained from patients operated and treated at the Gynecologic Oncology Unit at Meir Medical Center. Colon cancer specimens will be obtained from patients that underwent colonoscopy at the Gastrointestinal Department at Meir Medical Center.
16216226|NCT01267448|Drug|Glipizide XL|The control group will receive Glipizide XL (10mg orally) for a total duration of 12 weeks.
16216227|NCT01267448|Drug|Saxagliptin + Metformin XR|The intervention group will receive Saxagliptin 5 mg daily for a total duration of 12 weeks.
16216228|NCT01267448|Drug|Metformin XR|The intervention group will receive Metformin XR 1000 mg daily and will be automatically titrated weekly in 2 weeks to Metformin XR 2000 daily for a total duration of 12 weeks.
16216229|NCT01267435|Procedure|Anterior cruciate ligament reconstruction|reconstruct the anterior cruciate ligament rupturing
16216230|NCT01267422|Drug|rAAV2-ND4|injection
16216231|NCT01267409|Other|STN stimulation|Manipulating emotional processing of PD patients by high and low frequency stimulation of their subthalamic area (through the 4 DBS contacts) after the surgery
16216232|NCT01267396|Drug|Sertraline|Sertraline Hydrochloride Tablets 100 mg
16216233|NCT01267383|Drug|Sertraline|Sertraline Hydrochloride Tablets 100 mg
16216234|NCT01267370|Dietary Supplement|Soy polysaccharide fiber|"Dietary Supplement: Soy polysaccharide fiber First, disimpaction was carried out with phosphate enemas for 1 to 3 days. After the children have been cleaned out, they received a soy polysaccharide fiber supplement (powder containing 70 g of fiber/100 g) or placebo (purified soy extract, with no fiber) for 6 weeks. Fiber and placebo were given as a standard dose for the different age groups (median of 0,57 g/kg/day) - 2 to 5 years, 10 g/day; 6 to 9 years, 15 g/day; and > 10 years, 20 g/day.
~The child that had fecal impaction (a dilated rectum filled with a large amount of stool on rectal examination) during the follow-up was treated by administering phosphate enemas for 1 to 3 consecutive days.
~Arms: Soy polysaccharide fiber, purified soy extract, with no fiber
~Other Names:
~Soy polysaccharide fiber (Pró-fibra®) Purified soy extract, with no fiber (Soyac®)"
16216235|NCT01267357|Other|no intervention|
16216236|NCT01267344|Drug|gemcitabine, oxaliplatin|GEMOX (intravenous infusion of gemcitabine 800 mg/m2 at a fixed rate of 10 mg/m2/min followed by oxaliplatin 85 mg/m2 2-hour infusion, every 2 weeks
16216237|NCT01267344|Drug|cetuximab, gemcitabine, oxaliplatin|E-GEMOX: intravenous infusion of cetuximab (120 minutes for the 1st, 90 minutes for the 2nd and 60 minutes for all subsequent infusions) before GEMOX will be administered as above. All of the study medication will be administrated on day 1 every 2 weeks, which is regarded as one cycle.
16216238|NCT01267331|Procedure|bone marrow mononuclear cells injection|Participants will receive direct intramyocardial injection of autologous bone marrow mononuclear cells during CABG.
16216239|NCT01267331|Procedure|placebo intramyocardial injection|Participants will receive between 10 and 15 placebo injections that consist of saline and 5% human serum albumin during CABG.
16216240|NCT01267305|Drug|Fondaparinux|2.5mg IH qd(8AM) after operation
16216241|NCT01267305|Drug|Nadroparin Calcium|4100AxaIU IH qd(8AM) after operation
16216242|NCT01267305|Drug|Nadroparin Calcium|4100AxaIU IH q12h(8Am,8Pm) after operation
16216243|NCT01267292|Drug|Buspirone|[week 1: Buspirone 30 mg twice a day (9am and 6pm) on Monday through Sunday] [weeks 2-3: Buspirone 45 mg twice a day (9am and 6pm) on Monday through Sunday]
16216244|NCT01267292|Drug|Placebo for Buspirone|[week 1: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday] [weeks 2-3: Placebo for Buspirone twice a day (9am and 6pm) on Monday through Sunday]
16216245|NCT01267292|Drug|Methylphenidate|Methylphenidate serves as an acute stimulant challenge. [week 1: no Methylphenidate or Methylphenidate placebo] [week 2: 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
16216246|NCT01267292|Drug|Placebo for Methylphenidate|[week 1: no Methylphenidate or Methylphenidate placebo] [week 2: 0mg Methylphenidate (placebo for Methylphenidate) on Monday at 10am; Methylphenidate once a day (10am) on Wednesday and Friday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)] [week 3: Methylphenidate once a day (10am) on Monday and Wednesday, and on each of these 2 days the Methylphenidate dose will be different (15 mg, 30mg, 60 mg, or 0mg)]
16216247|NCT01267279|Drug|Zoledronic acid|Zoledronic acid per protocol
16216248|NCT01267279|Other|Placebo|Placebo
16216249|NCT01267266|Drug|saracatinib|Given orally
16216250|NCT01267266|Other|hydrocortisone/placebo|Given orally
16216251|NCT01267253|Drug|Brivanib Alaninate|Given PO
16216252|NCT01267253|Other|Laboratory Biomarker Analysis|Correlative studies
16216253|NCT01267240|Drug|Capecitabine|Given PO
16216254|NCT01267240|Drug|Vorinostat|Given PO
16216255|NCT01267227|Drug|Pterostilbene 50 mg twice daily|Pterostilbene 50 mg twice by mouth daily for 6 to 8 weeks
16216256|NCT01267227|Drug|Placebo|Matching placebo by mouth twice daily for 6 to 8 weeks
16216257|NCT01267227|Drug|Grape Extract|Grape extract 100 mg twice daily for 6-8 weeks
16216258|NCT01267227|Drug|Pterostilbene 125 mg twice daily|Pterostilbene 125 mg twice daily for 6-8 weeks
16216259|NCT01267214|Drug|Sodium Hyaluronate (Hyalgan)|1% Sodium Hyaluronate in prefilled syringe
16216260|NCT01267214|Procedure|Osteotomy alone|no injection
16216261|NCT01267201|Drug|methylprednisolone|powder for oral suspension 4 mg/mL single dose (8 mL)
16216262|NCT01267201|Drug|methylprednisolone|powder for oral suspension 4 mg/mL singe dose (8 ml)
16216263|NCT01267201|Drug|methylprednisolone|tablet 32 mg single dose
16216264|NCT01267188|Drug|NBI-98854|powder in bottle, prepared doses at 12.5, 25, and 50 mg q.d. administered for up to 12 days consisting of three treatment periods of 4 days each
16216265|NCT01267175|Device|X54 insulin pump with low suspend feature|Change from current insulin pump to new X54 pump
16216266|NCT01267136|Drug|Codeine with acetaminophen|Liquid codeine/acetaminophen (Capital® 5mL= 120mg acetaminophen/12 mg codeine) 0.72 mg/kg [=0.3 mL/kg] (max. 36 mg) PO Q6h, plus 0.72 mg/kg (max. 36 mg) PO Q3h pro re nata (PRN) (max. of 3 PRN doses/day)
16216267|NCT01267136|Drug|Tramadol suspension|Liquid tramadol 1.05 mg/kg [=0.3 mL/kg] (max. 52.5 mg) PO Q6h, plus 1.05 mg/kg (max. 52.5 mg) PO Q3h PRN (max. of 3 PRN doses/day).
16216268|NCT01267123|Procedure|Trendelenburg position|The patient will be placed in the Trendelenburg position with a 15 degree angle of inclination
16216269|NCT01267123|Procedure|Standard care|The patient will be placed in the standard horizontal position
16216270|NCT01267110|Other|MI2 intervention arm|For persons who are randomized to the MI2 intervention arm, the HLK-BH program will guide participants through a series of questions to fully delineate step-by-step breast cancer screening intentions of participants the when, where and how of screening)and encourage follow through on these intentions.
16216271|NCT01267110|Other|Control|Each participant in the C intervention arm will receive the same brief one-on-one breast cancer screening education information delivered in person by a CHW as MI2 participants. In additional participants will go through the Healthy Living Kansas-Breast Health computerized screening and intervention program.
16216272|NCT01267097|Behavioral|Cognitive Behavioural Therapy (CBT)|Clinical research supports the use of CBT-based interventions in weight management for adults and children. However, the current study will advance the existing knowledge-base by combining CBT with the parents as agents of change approach for pediatric weight management. CBT is a theoretically-based therapy that focuses on the role that cognitive processes play in the maintenance of problem behaviours, mood states, and habits. CBT highlights the relationship between thoughts, feelings and actions, and utilizes techniques involving motivation, goal-setting, problem-solving, and knowledge/skill acquisition that can facilitate sustainable behaviour changes.
16216273|NCT01267097|Behavioral|Psycho-Education Program (PEP)|PEP is a knowledge-based intervention that is modelled after traditional nutrition and health education programs. Research has demonstrated that knowledge based programs can improve health behaviours and outcomes in overweight and obese populations. In relation to CBT, PEP is a more passive intervention and there is limited focus on active skill building. While PEP does not represent a true control group, its content and delivery are consistent with what many clinicians provide for weight management.
16216274|NCT01267084|Drug|Trabectedin|Patients will receive trabectedin 1.3 mg/m2 when given alone and 0.2mg/m2 when given with ketoconazole, intravenously (into a vein) for 3-hour.
16216275|NCT01267084|Drug|Ketoconazole|Patients will receive ketoconazole 1 X 200 mg tablet, two times a day, orally (by mouth)
16216276|NCT01267084|Drug|Dexamethasone or equivalent steroid|Patients will receive dexamethasone 20 mg or equivalent steroid intravenously, 30 minutes before trabectedin in each cycle.
16216277|NCT01267071|Drug|A|GSK962040 (50 mg, SD, oral)
16216278|NCT01267071|Drug|B|14C GSK962040 (100 μg, SD, iv)
16216279|NCT01267058|Biological|GSK Biologicals' combined diphtheria, tetanus, acellular pertussis vaccine|Intramuscular, single dose
16216280|NCT01267058|Biological|GSK Biologicals' acellular pertussis vaccine|Intramuscular, single dose
16216281|NCT01267058|Biological|Commonwealth Serum Laboratories' combined diphtheria and tetanus vaccine|Intramuscular, single dose
16216282|NCT01267045|Behavioral|Mindfulness-based stress reduction|Mindfulness-Based Stress Reduction (MBSR) teaches mindfulness as a non-religious practice of self-observation and self-awareness. Kabat-Zinn developed MBSR in 1979 in response to a growing awareness that medical interventions were often inadequate at addressing chronic pain issues and restoring function and life satisfaction. He drew on his meditation and yoga training to develop this program as a complement to traditional medicine that could help patients live fully despite their chronic medical and psychiatric conditions. Through MBSR an individual's emphasis shifts from a preoccupation with what is wrong to a growing appreciation for what is right and what can be built upon.
16216283|NCT01267032|Behavioral|Integrated Care|A PTSD-aware smoking cessation intervention developed by Miles McFall, PhD.
16216284|NCT01267032|Behavioral|Cognitive-Behavioral Treatment for Insomnia|A behavioral treatment aimed at improving sleep continuity and subjective sleep through stimulus control, sleep restriction, and attenuation of maladaptive sleep-related cognitions.
16216285|NCT01267032|Behavioral|Desensitization Treatment for Insomnia|A credible sham treatment for insomnia matching CBTI in treatment time, patient expectations, therapist expectations, etc.
16216286|NCT01267019|Behavioral|social cognitive training with in vivo augmentation|24 sessions of social cognitive training plus 6 sessions of in vivo exercises
16216287|NCT01267019|Behavioral|social cognitive training|30 sessions of social cognitive training without in vivo exercises
16216288|NCT01267019|Behavioral|non-social skills training|30 sessions of skills training that has no specific social content
16216289|NCT01267006|Drug|GSK1325756|GSK1325756 will be available as white, film coated immediate release tablets with dose strengths of 50 mg, 100 mg and 200 mg. The tablets will be administered twice daily by oral route with 240 milliliters of water.
16216290|NCT01267006|Drug|Placebo tablet|Placebo will be available as white film coated GSK1325756 matching tablet which will be administered twice daily by oral route with 240 milliliters of water.
16216291|NCT01266993|Biological|Nimenrix (GSK134612 vaccine)|Intramuscular, 1 dose
16216292|NCT01266993|Biological|Menjugate|Intramuscular, 1 dose
16216293|NCT01266980|Drug|Inhaled FF/ GW642444M (200/25mcg)|All subjects will be assigned to take FF/ GW642444M (200/25mcg) combination once daily for 7 days.
16216294|NCT01266967|Drug|GSK2118436|Subjects in this study receive 150 mg of GSK2118436 twice daily and continue on treatment until disease progression, death, or unacceptable adverse event.
16216295|NCT01266954|Drug|GSK2141795|GSK2141795 is an oral, low nanomolar pan-AKT kinase inhibitor that demonstrates activity in hematologic and solid tumor cell lines. It also delays tumor growth in a dose dependent manner in solid tumor xenograft mouse models
16216296|NCT01266941|Drug|Inhaled FF 200mcg/GW642444M 25mcg|All subjects are scheduled to receive FF 200mcg/GW642444M 25mcg once daily for 7 days. The dose for subjects with severe hepatic impairment may be adjusted to FF 100mcg/GW642444M 12.5mcg after review of the PK and safety data from the moderate and healthy matched control subjects.
16216297|NCT01266928|Drug|vitamine C and E|Eligible and consenting women were randomly assigned to capsules containing a combination of 1,000 mg vitamin C (ascorbic acid) and 400 international units of vitamin E (RRR alpha tocopherol acetate)
16216298|NCT01266902|Drug|Rilpivirine|25 mg once daily
16216299|NCT01266889|Device|device:INVOS 5100|Continuous wave NIRS is a method for measurement of cerebral oxygenation and haemodynamics. This method is non-invasive, continuous, and can also be used as bedside monitoring. With continuous wave NIRS only changes in concentration of oxyhaemoglobin (O2Hb) and deoxyhaemoglobin (HHb) can be measured, not the absolute level of these parameters. It has been shown that changes in concentration of HbD (O2Hb - HHb) reflect changes in CBF. So, continuous monitoring of changes in concentration of HbD can be used as an indicator of changes in CBF, but changes in CBV will also influence the HbD signal, as will changes in arterial O2 saturation (saO2) and changes in cerebral metabolic rate for oxygen.
16216300|NCT01266876|Drug|Alirocumab|Alirocumab two SC injections in the abdomen only.
16216301|NCT01266876|Drug|Placebo|Placebo two SC injections in the abdomen only.
16216302|NCT01266863|Other|E test method|E test strips directly applied to BAL
16216303|NCT01266850|Biological|Rotarix®|Each 1-mL dose of Rotarix® contains a suspension of at least 10^6 median Cell Culture Infective Dose (CCID50) of live, attenuated human G1P rotavirus after reconstitution. The lyophilized vaccine contains amino acids, dextran, Dulbecco's Modified Eagle Medium (DMEM), sorbitol, and sucrose. The liquid diluent contains calcium carbonate, sterile water, and xanthan. The diluent includes an antacid component (calcium carbonate) to protect the vaccine during passage through the acid environment of the stomach. Rotarix® contains no preservatives. Once reconstituted, the vaccine will appear white and turbid.
16216304|NCT01266850|Biological|RotaTeq®|2-mL ready-to-use oral solution of live reassortant rotaviruses, containing G1, G2, G3, G4, and P1A, which contains a minimum of 2.0 to 2.8 x 10^6 infectious units (IU) per individual reassortant dose, depending on the serotype, and not greater than 116 x 10^6 IU per aggregate dose. The buffered stabilizer solution contains sucrose, sodium citrate, sodium phosphate monobasic monohydrate, sodium hydroxide, polysorbate 80, cell culture media, and trace amounts of fetal bovine serum. RotaTeq® contains no preservatives. RotaTeq® is a pale yellow clear liquid that may have a pink tint.
16216305|NCT01266837|Drug|Everolimus|10 mg p.o once daily
16216306|NCT01266824|Drug|Proparacaine Hydrochloride Ophthalmic Solution|1 drop into each eye once prior to the first set of mydriatic (dilating) eye drops
16216307|NCT01266811|Drug|Placebo, Velcade and dexamethasone|Siltuximab 11 mg/kg as 1 hour IV infusion on Day 1 of every cycle
16216308|NCT01266811|Biological|Siltuximab, Velcade and dexamethasone|Given in 21-day treatment cycles
16216338|NCT01266603|Drug|HDIL-2|720,000 IU/kg by vein over an approximate 15 minute period every eight hours, for a maximum of 14 doses per cycle.
16216339|NCT01266603|Biological|recMAGE-A3 + AS15|300 μg plus 420 μg of CpG7909 (a part of the Adjuvant System AS15) by intermuscular injection within 24 hours from first dose of HDIL-2.
16216340|NCT01266590|Drug|LY2216684|Administered orally
16216341|NCT01266590|Drug|Digoxin|Administered orally
16216309|NCT01266798|Behavioral|Portal|"The portal was tailored to improve the lay public's' healthy skepticism, or in other words, critical and social literacy skills to assist patients in the decision-making process and for improving access to health information and participation. Illustrated by typical examples which can be found in the news and through patient stories, the portal provides an introduction to research methods, the underlying principles of science and critical assessment tools appropriate for a lay public.
~A checklist for critical assessment of health information
~Access to research databases for health information and an introduction to research methods and principles of science
~A checklist to the consultation"
16216310|NCT01266785|Drug|Infliximab|Patient will receive Infliximab infusions during Weeks 0, 2 and 6. Therefore, the duration of the Infliximab treatment will last 6 weeks.
16216311|NCT01266772|Drug|Montelukast sodium.|Children with asthma treated with montelukast and budesonide.
16216312|NCT01266772|Drug|Placebo tablet and budesonide|Children with asthma treated with placebo tablet and budesonide.
16216313|NCT01266759|Drug|NuvaRing|For the first cycle, women inserted the ring between days 1 and 5 of the menstrual cycle. Treatment continued for three cycles. Each cycle consisted of 3 weeks of ring use followed by a 1 week ring-free period.
16216314|NCT01266759|Drug|Norethisterone Acetate tablets - 5mg|Norethisterone Acetate tablets 5 mg three times daily from day 5 to 26 of the cycle over three cycles. Male condom used for contraception during treatment
16216315|NCT01266746|Procedure|Vitreous surgery|Vitreous surgery is performed to treat the original disease not for the study.
16216316|NCT01266733|Behavioral|Interdisciplinary treatment|The Experimental Group received 6 weeks of interdisciplinary treatment of fibromyalgia combining coordinated psychological, medical, educational, and physiotherapeutic interventions delivered by a team that included a physician, a psychologist, and a physiotherapist.Patients in the EG were divided into groups of 12 individuals. Each attended biweekly group sessions of 1 hour and 45 minutes, for a total of 12 sessions. One session included 1 hour with the psychologist and 45 minutes of educational activities with the physician and psychologist, while the other session included 1 hour with the psychologist and 45 minutes with the physiotherapist.
16216317|NCT01266733|Behavioral|Interdisciplinary treatment of fibromyalgia|The Control Group received the usual standard of care, which included pharmacologic treatment with a tricyclic antidepressant (amitriptyline, maximum dose of 75 mg/24h), an analgesic (paracetamol, maximum dose of 4 grams/24h), and a non-opioid central analgesic (tramadol, maximum dose of 400 mg/24h). The Experimental Group (EG) received 6 weeks of interdisciplinary treatment combining coordinated PSYchological, Medical, Educational, and PHYsiotherapeutic interventions (PSYMEPHY) delivered by a team that included a physician, a psychologist, and a physiotherapist. Patients in the EG were divided into groups of 12 individuals. Each attended biweekly group sessions of 1 hour and 45 minutes, for a total of 12 sessions.
16216318|NCT01266720|Biological|VEGFR1, VEGFR2|One mg of each peptide will be administered subctaneously on days 1, 8, 15 and 22
16216319|NCT01266720|Drug|Gemcitabine|Gemcitabine will be administered intravenously at a fixed dose of 1000mg/m2 on day 1, 8, 15.
16216320|NCT01266707|Biological|antiangiogenic paptide vaccine|for drugs include administration time frame
16216321|NCT01266694|Drug|Colchicines|oral form, 1 mg, once a day during 14 days
16216322|NCT01266694|Drug|Placebo|oral form, placebo
16216323|NCT01266681|Drug|amiodarone|"Visit One:. Once consent is given patarticipants will be randomised into either group and instructed and prescribed the drug as appropriate.
~Visit Two: Patients will attend for routine cardioversion. This is performed by an experienced CCU nurse as per normal protocol. Patients will also undergo an ECG, and fill in symptom and quality of life (QoL) questionnaires.
~Visit Three: Patients will attend a routine outpatient appointment 6 weeks post cardioversion. They will undergo ECG and fill in symptom and QoL questionnaires
~Visit Four: Participants will attend at 12 weeks for ECG, symptom and QoL questionnaires
~Visit Five: Participants will attend at 24 weeks for ECG, symptom and QoL questionnaires
~Visit Six: Participants will attend at 36 weeks for ECG, symptom and QoL questionnaires
~Visit Seven: Participants will attend at 52 weeks for ECG, symptom and QoL questionnaires. Participants will then be followed up as per protocol by their consultant cardiologist."
16216324|NCT01266681|Drug|Dronedarone|"Visit One: patarticipants will be randomised into either group and instructed and prescribed the drug as appropriate.
~Visit Two: Patients will attend for routine cardioversion. This is performed by an experienced CCU nurse as per normal protocol. Patients will also undergo an ECG, and fill in symptom and quality of life (QoL) questionnaires.
~Visit Three: Patients will attend a routine outpatient appointment 6 weeks post cardioversion. They will undergo ECG and fill in symptom and QoL questionnaires
~Visit Four: Participants will attend at 12 weeks for ECG, symptom and QoL questionnaires
~Visit Five: Participants will attend at 24 weeks for ECG, symptom and QoL questionnaires
~Visit Six: Participants will attend at 36 weeks for ECG, symptom and QoL questionnaires
~Visit Seven: Participants will attend at 52 weeks for ECG, symptom and QoL questionnaires. Participants will then be followed up as per protocol by their consultant cardiologist."
16216325|NCT01266655|Drug|Baclofen|Baclofen will be administered orally for a maximum of 20 consecutive weeks. For the first 3 days, patients will receive baclofen in a dose of 5 milligrams t.i.d.; subsequently, the daily dose of baclofen will be increased to a maximum of 90 milligrams t.i.d. within 4 weeks. In case of intolerance, dosage can be decreased to a minimum of 10 mg t.i.d.. Patients will receive maximum tolerated dosage of baclofen for 12 weeks. Medication will then gradually be tapered over a maximum of 4 weeks.
16216326|NCT01266655|Drug|Placebo|Placebo
16216327|NCT01266642|Radiation|External Beam Radiation Therapy|Undergo HF-WBI
16216328|NCT01266642|Radiation|External Beam Radiation Therapy|Undergo CF-WBI
16216329|NCT01266642|Radiation|Hypofractionated Radiation Therapy|Undergo HF-WBI
16216330|NCT01266642|Other|Laboratory Biomarker Analysis|Optional correlative studies
16216331|NCT01266642|Other|Quality-of-Life Assessment|Ancillary studies
16216332|NCT01266642|Other|Questionnaire Administration|Ancillary studies
16216333|NCT01266642|Radiation|Whole Breast Irradiation|Undergo HF-WBI
16216334|NCT01266642|Radiation|Whole Breast Irradiation|Undergo CF-WBI
16216335|NCT01266616|Biological|Profectus HIV MAG pDNA vaccine|3,000 mcg admixture of two vaccine plasmids: ProfectusVax DNA Plasmid (HIV-1 gag/pol) and ProfectusVax DNA Plasmid (HIV-1 nef/tat/vif, env) at Weeks 0, 4, and 12
16216336|NCT01266616|Biological|IL-12|Administered at Weeks 0, 4, and 12
16216337|NCT01266616|Other|Placebo|Saline injections at Weeks 0, 4, and 12
16216344|NCT01266551|Device|car safety seat|The positions in the car safety seat and in supine 15 degrees anti-Trendelenburg are compared on the basis of a 20 hour pH monitoring.In one group the infants were first continuously positioned at 45 degrees elevation in a car safety seat (car safety seat type Maxi cosi Citi for infants from 0-13kg). During the next period the infants were kept in a supine 15 degrees anti-Trendelenburg position (hospital infant bed), and vice versa for the other group.
16216345|NCT01266525|Drug|SAR110894|"Pharmaceutical form: Capsule
~Route of administration: Oral"
16216346|NCT01266525|Drug|placebo (for SAR110894)|"Pharmaceutical form: Capsule
~Route of administration: Oral"
16216347|NCT01266525|Drug|Donepezil|5 mg or 10 mg once daily continued as taken before inclusion
16216348|NCT01266512|Drug|DOCETAXEL|Pharmaceutical form: docetaxel 20mg or 80 mg concentrate for solution for infusion Route of administration: intravenous
16216349|NCT01266512|Radiation|Intensity Modulated Radiotherapy (IMRT)|2 Gy per fraction
16216350|NCT01266512|Drug|CISPLATIN|Pharmaceutical form: solution for infusion Route of administration: intravenous
16216351|NCT01266499|Drug|Colistin (Polymyxin E) 100mg x 4/d|Colistin (Polymyxin E) 100mg x 4/d
16216352|NCT01266499|Drug|both medications|PO Garamycin 80mg x 4/d +PO Colistin (Polymyxin E) 100mg x 4/d
16216353|NCT01266499|Drug|will not receive PO treatment|will not receive PO treatment - will receive plecebo treatment
16216354|NCT01266499|Drug|PO Garamycin 80mg x 4/d|PO Garamycin 80mg x 4/d
16216355|NCT01266486|Drug|Metformin|Extended release Metformin 1500mg once daily for 14-21 days
16216356|NCT01266473|Other|Physiotherapy|Physiotherapy for Airway Clearance
16216357|NCT01266460|Biological|Attenuated Live Listeria Encoding HPV 16 E7 Vaccine ADXS11-001|Given IV
16216358|NCT01266460|Other|Laboratory Biomarker Analysis|Correlative studies
16216359|NCT01266447|Biological|Filgrastim|Given SC
16216360|NCT01266447|Other|Laboratory Biomarker Analysis|Correlative studies
16216361|NCT01266447|Biological|Pegfilgrastim|Given SC
16216362|NCT01266447|Drug|Topotecan Hydrochloride|Given IV
16216363|NCT01266447|Drug|Veliparib|Given PO
16216364|NCT01266434|Drug|Simvastatin|10 mg once daily for 8 weeks
16216365|NCT01266434|Drug|B1-6-12|1 tablet once daily for 8 weeks
16216366|NCT01266382|Device|AposTherapy|a biomechanical device including 2 hemispheric biomechanical elements attached to a platform in a form of a shoe. the biomechanical device is calibrated to each patient by a physiotherapist specialized with the treatment methodology. patient are instructed to walk indoor with the device. time of exercise is gradually increase
16216367|NCT01266369|Drug|masitinib|
16216368|NCT01266330|Dietary Supplement|Low Dairy|Less than 0.5 standard servings of dairy products per day
16216369|NCT01266330|Dietary Supplement|Adequate Dairy|3.5 standard servings of dairy foods per day
16216370|NCT01266317|Drug|Combined Plasma Exchange (PEX), Rituximab, and Corticosteroids|Standard Steroid Treatment, Plasma exchange will consist of 1.5x estimated plasma volume exchanges, Rituximab
16216371|NCT01266291|Drug|vigabatrin|Subjects will begin taking vigabatrin (Sabril) during the third month of the study. Upward titration will happen at a rate of 500mg per week until subjects reach their maximum tolerated dose, or 3g per day (whichever is lower). This dose may be decreased if needed under the supervision of the study doctor. Subjects who need to lower their dose or who stop taking Sabril will have their dosage decreased at a rate of 1 gm/week for one month under the supervision of the study doctor.
16216372|NCT01266278|Other|Dynamic ultrasound|Measurement of the size of the subacromial space with dynamic ultrasound.
16216373|NCT01266278|Other|FASTRAK|Measurements of the 3D-kinematics of the shoulder with FASTRAK. Sensors are placed on the skin of the shoulder with adhesive tape.
16216374|NCT01266278|Other|Assessment of shoulder posture by measuring|Assessment of shoulder posture by measuring several angles and distances.
16216375|NCT01266265|Drug|inhaled prostacyclin|Tyvaso
16216376|NCT01266265|Drug|inhaled prostacyclin|As prescribed by the physician
16216377|NCT01266265|Drug|prostacyclin|As prescribed by the physician
16216378|NCT01266265|Drug|subcutaneous and intravenous prostacyclin|As prescribed by physician
16216379|NCT01266265|Drug|oral ERA|As prescribed by physician
16216380|NCT01266265|Drug|oral PDE5 inhibitors|As prescribed by physician
16216381|NCT01266252|Drug|Dexmedetomidine|"Dexmedetomidine will be given maximal 72 hours. In case analgosedation is still needed after stop of the dexmedetomidine infusion, the treatment is switched to conventional analgosedation regimens.
~Additional drugs are given to every inadequately sedated-painful patient (assessed by regular Comfort-neo and Numeric Rating Scale scoring). In case of oversedation or adverse drug events (hypotension, bradycardia), a downtitration (or stop) of the dexmedetomidine infusion is needed."
16216382|NCT01266239|Procedure|kissing balloon inflation|Kissing balloon inflation following the MV stenting
16216383|NCT01266239|Device|EES vs. SES|Rapid endothelialization after EES deployment has been reported compared to that after SES deployment.
16216384|NCT01266226|Device|Autologous conditioned plasma|4mL autologous conditioned plasma application under the footprint following an arthroscopic repair of the rotator cuff.
16216385|NCT01266226|Device|Control group|4mL saline application under the footprint following an arthroscopic repair of the rotator cuff.
16216386|NCT01266213|Drug|Fulvestrant plus Goserelin|Fulvestrant s.c. plus Goserelin s.c.
16216387|NCT01266213|Drug|Anastrozole plus Goserelin|Anastrozole 1 mg p.o. plus Goserelin s.c.
16216388|NCT01266213|Drug|Goserelin|Goserelin s.c.
16216389|NCT01266200|Procedure|Mantis|percutaneous minimal-invasive technique at the thoracal-lumbal junction with for cuts of about 3 cms
16216390|NCT01266200|Procedure|XIA|Treatment of the fracture with Xia and conventional operation technique
16216391|NCT01266187|Procedure|adjuvant surgery + FOLFOX + cetuximab|surgery -> 4-8 weeks rest -> 24 weeks FOLFOX + cetuximab
16216392|NCT01266187|Procedure|perioperative/Folfox + cetuximab|"12 weeks FOLFOX + cetuximab -> 4 weeks rest -> surgery
~-> 4-8 weeks rest -> 12 weeks FOLFOX + cetuximab"
16216393|NCT01266174|Drug|Eltoprazine|Comparison of eltoprazine, dosed orally, for 8 weeks
16216395|NCT01266161|Drug|Ibuprofen 600 mg ER|One 600 mg caplet dosed at 0, 12, 24 and 36 hours
16216396|NCT01266161|Drug|Placebo|One placebo caplet dosed at times 0, 12, 24 and 36 hours
16216397|NCT01266148|Drug|Cyclosporine|Cyclosporine (CsA) control group target blood level: 150-350 ng/mL (month 1-3); 100-250 ng/mL (month 4-6); 60-200 ng/mL (month 7-12); everolimus group target blood level: 75-175 ng/mL (month 1-3)
16216398|NCT01266148|Drug|Mycophenolate mofetil|Mycophenolate mofetil (MMF) target dose for control group: 2000-3000 mg/day everolimus group target dose: 1500-2000 mg/day and 75-175 ng/mL after week 11
16216399|NCT01266148|Drug|Corticosteroids|Corticosteroids (CS) initiated at 0.2-0.5 mg/kg/day. Tapered to no less than 0.1 mg/kg at Month 3 for control and everolimus groups.
16216400|NCT01266148|Drug|Everolimus|Everolimus 0.75 mg twice a day as starting dose up to a target blood level: 3-6 ng/mL (7-11 weeks) and 6-10 ng/mL for remaining of study
16216401|NCT01266148|Drug|Anti Thymocyte Globulin|Induction therapy, Anti Thymocyte Globulin (ATG): 1-2 mg/kg/day during 3-5 days for control and everolimus groups after transplant surgery and prior to randomization.
16216402|NCT01266135|Drug|QAX576|QAX576 10 mg/kg intravenous infusion
16216403|NCT01266135|Drug|Placebo|Placebo to QAX576 intravenous infusion
16216404|NCT01266122|Behavioral|Behavioral intervention|The behavioral intervention will consist of 4 group sessions and 4 individual sessions over 3 months. The overall focus is on psychosocial concerns and HIV risk.
16216405|NCT01266109|Behavioral|Contingency Management-Family Engagement (CM-FAM)|Evidence-based outpatient intervention for adolescent substance use
16216406|NCT01266109|Other|Usual Services (US)|Typical community-based substance abuse treatment services
16216408|NCT01266083|Biological|WT1 peptide vaccine|Six vaccinations of the WT1 peptide preparation (1.0 ml of emulsion) will be administered on weeks 0, 2, 4, 6, 8, and 10. All vaccinations will be administered subcutaneously with vaccination sites rotated among extremities. Patients who are clinically stable and have not had disease progression, may receive up to 6 more vaccinations administered appropriately every month.
16216409|NCT01266070|Drug|Dovitinib|500 mg (5 capsules) daily by mouth on Days 1-5, 8-12, 15-19, and 22-26 of each 28-day cycle (i.e. 5 days on, 2 days off schedule).
16216410|NCT01266057|Drug|Hydroxychloroquine|Starting dose of 200 mg by mouth every day for a 21 day cycle.
16216411|NCT01266057|Drug|Sirolimus|Starting dose of 2 mg by mouth every day for a 21 day cycle.
16216412|NCT01266057|Drug|Vorinostat|Starting dose of 200 mg by mouth per day for a 21 day cycle.
16216413|NCT01266044|Procedure|Acupuncture - Group 1|Acupuncture at 14 points. The needles will remain in place for 20 minutes with each treatment.
16216414|NCT01266044|Procedure|Acupuncture - Group 2|Acupuncture needles placed at different points from Group 1. The needles will remain in place for 20 minutes with each treatment.
16216415|NCT01266044|Other|Standard Care|Standard oral care recommendations. Participants in all groups will receive the same recommendations.
16216416|NCT01266044|Other|Questionnaire|Baseline assessments will be completed within 7 days prior to starting radiotherapy, and patients will then complete the same assessments again at week 4 and 7 of radiotherapy and 3, 6, and 12 months after the end of radiotherapy.
16216417|NCT01266031|Drug|vorinostat|Vorinostat 400mg/day will be administered on day 1 to 7 and day 15 to 21 orally on a 28 day cycle in the arm with combination of vorinostat and bevacizumab. Vorinostat will be administered orally. Vorinostat capsules should not be opened or crushed and must be administered whole.
16216418|NCT01266031|Drug|bevacizumab|Bevacizumab 10mg/kg will be administered on day 1 and 15 intravenously on a 28 day cycle in both arms.
16216419|NCT01266018|Drug|ADI-PEG 20 (Arginine deiminase pegylated)|ADI-PEG 20 was administered intramuscularly (IM) at a fixed dose of 320 IU/m^2 (36.8 mg/m^2) once weekly for 4 weeks followed by a 1-week follow-up (1 cycle)
16216420|NCT01266005|Drug|Clevudine|30mg,QD
16216421|NCT01266005|Drug|Entecavir|0.5mg QD
16216422|NCT01265979|Procedure|Whole body diffusion MRI|These studies will be performed on a 3 Tesla (T) MR system. A major advantage of 3T compared to 1.5T is the improved signal to noise ratio that allows whole-body studies to be faster and without application of external antennas, which greatly improves patient comfort.
16216423|NCT01265953|Drug|SFN-rich broccoli sprout extract capsules|Four weeks SFN-rich broccoli sprout extract (BSE) capsules: 200µmol of SFN, 2 capsules (1 capsule B.I.D.) daily
16216424|NCT01265953|Dietary Supplement|Gelatin capsule containing microcrystalline cellulose.|Four weeks placebo capsules: 2 capsules (1 capsule B.I.D.) daily
16216425|NCT01265940|Drug|Pazopanib as add-on to vinflunine|"Patients will receive vinflunine standard regimen (intravenous infusion every three weeks) as specified per drug label plus additional pazopanib as daily oral medication. Doses of pazopanib will be escalated in 200 mg/d steps during phase I up to a maximum of 800 mg/d.
~In Phase II the patients will be given pazopanib + vinflunine at maximum tolerated dose."
16216426|NCT01265927|Drug|GRN163L in combination with trastuzumab|GRN163L will be administered in escalating dose cohorts on Day 1 of each 21-day cycle prior to trastuzumab infusion. Trastuzumab will be a administered day 1 of each 21-day cycle after GRN163L. There will be a 30 minute observation period between the end of the GRN163L infusion and the beginning of the trastuzumab infusion.
16216427|NCT01265914|Biological|FP-01.1|Ascending doses of FP-01.1 will be administered
16216428|NCT01265914|Biological|placebo|
16216429|NCT01265901|Drug|Sunitinib|As per label.
16216430|NCT01265901|Biological|GM-CSF|Intradermal injection of GM-CSF as adjuvant.
16216431|NCT01265901|Drug|Cyclophosphamide|One single low-dose i.v. infusion prior to the first vaccination
16216432|NCT01265901|Drug|IMA901|Intradermal vaccinations with IMA901 vaccine.
16216474|NCT01265615|Drug|Cholecalciferol|cholecalciferol group (intake of cholecalciferol with recommended daily allowance equals 1200-2400 IU per day)
16218364|NCT01251159|Other|immunologic technique|
16216433|NCT01265888|Drug|Inhaled Nitric Oxide|Inhaled nitric oxide 80 ppm via nasal cannula at 1 LPM for 15 minutes followed by placebo washout of 15 minutes inhalation of medical grade air (or prescribed supplemental oxygen), and then inhaled nitric oxide 80 ppm via nasal cannula at 1 LPM
16216434|NCT01265888|Drug|Inhaled Nitric Oxide|Inhaled nitric oxide 80 ppm via nasal cannula at 1 LPM for 15 minutes followed by placebo washout of 15 minutes inhalation of medical grade air (or prescribed supplemental oxygen), and then inhaled nitric oxide 80 ppm via nasal cannula at 2 LPM
16216435|NCT01265888|Drug|Inhaled Nitric Oxide|Inhaled nitric oxide 80 ppm via nasal cannula at 1 LPM for 15 minutes followed by placebo washout of 15 minutes inhalation of medical grade air (or prescribed supplemental oxygen), and then inhaled nitric oxide 80 ppm via nasal cannula at 4 LPM
16216436|NCT01265875|Drug|Human Secretin|Dose Escalation
16216437|NCT01265862|Procedure|Tracheal intubation through LMA-Fastrach®|Tracheal intubation through a supraglottic airway device (LMA-Fastrach®) using a GlideRite® endotracheal tube
16216438|NCT01265862|Procedure|Tracheal intubation through I-gel®|Tracheal intubation through a supraglottic airway device (I-gel®) using a GlideRite® endotracheal tube
16216439|NCT01265849|Biological|LI|LI 400IU (2.0mL total daily) 1.0 mL peritumoral, 1.0 mL perilymphatic 5x weekly x3 weeks administered in combination with cyclophosphamide indomethacin and zinc (CIZ) as adjuvant therapy prior to SOC, (surgery followed by radiation or concurrent radiochemotherapy with cisplatin 100mg/m^2 intravenously) to determine if LI plus CIZ affects the overall survival of subjects at median 3 years.
16216440|NCT01265849|Drug|Cyclophosphamide|Cyclophoshamidie is administered IV bolus at a dose of 300mg/m^2 three days prior to beginning treatment with LI. Standard of care (SOC) for previously untreated squamous cell carcinoma of the head and neck is currently surgery followed by radiotherapy (60-70Gy in 30 to 35 fractions over 6 to 7 weeks) or for higher risk subjects (subjects determined at surgery to have positive surgical margins, 2 or more clinically positive nodes or extracapsular nodal spread) radiotherapy is combined with concurrent chemotherapy (cisplatin 100mg/m2 intravenously 1x weekly for 3 weeks on day 1 of weeks 1, 4 and 7 of radiotherapy
16216441|NCT01265849|Drug|Indomethacin|One 25mg capsule of indomethacin is administered orally beginning on day one of LI treatment daily until the day before surgery. for LI is administered 400 IU (2.0mL) 1/2 peritumorally and 1/2 perilymphatically 5 times a week for three weeks prior to SOC to determine the contribution of CIZ on LI activity.
16216442|NCT01265849|Dietary Supplement|Zinc|One capsule daily beginning on day one of treatment with LI until one day before surgery
16216443|NCT01265849|Procedure|Surgery|Surgery to remove tumor
16216444|NCT01265849|Drug|Cisplatin|Cisplatin is administered 100mg/m^2 IV is administered with concurrent chemotherapy (cisplatin 100mg/m2 intravenously 1x weekly for 3 weeks on day 1 of weeks 1, 4 and 7 of radiotherapy i
16216445|NCT01265849|Radiation|Radiotherapy|60 to 70Gy in 30 to 35 fractions over 6 to 7 weeks. In subjects determined at surgery to have positive surgical margins, 2 or more clinically positive nodes or extracapsular nodal spread radiotherapy is combined with concurrent chemotherapy (cisplatin 100mg/m2 intravenously 1x weekly for 3 weeks on day 1 of weeks 1, 4 and 7 of radiotherapy
16216446|NCT01265823|Biological|Adalimumab|Adalimumab was administered as follows: 80 mg at baseline, followed by 40 mg every other week (eow; starting at Week 1 until Week 15). The study drug was self-administered via subcutaneous (sc) injection.
16216447|NCT01265810|Other|supersaturated calcium-phosphate|4 times daily, 2 minutes rinse with 30 ml solution during active rinse period (14 days)
16216448|NCT01265810|Other|sodium chloride 0.9 %|4 times daily, 2 minutes rinse with 30 ml solution during active rinse period (14 days)
16216449|NCT01265797|Device|Cranial Electrostimulator|participant wears active cranial electrostimulation device for 20 minutes daily for 28 days
16216450|NCT01265797|Device|Sham Device|participant wears sham device for 20 minutes daily for 28 days
16216451|NCT01265784|Drug|TP-434|
16216452|NCT01265784|Drug|Ertapenem|
16216453|NCT01265784|Drug|Placebo|Administered IV to maintain the blind.
16216454|NCT01265771|Device|Prolonged telemetric Full Disclosure ECG recording.|Thirty days Telemetric Full Disclosure ECG monitoring; subsequently analyzed in the Event Holter monitoring mode
16216455|NCT01265771|Device|Repeated 24 hours ECG Holter monitoring|Repeated 24 hours ECG Holter monitoring
16216456|NCT01265758|Device|Prolonged telemetric Full Disclosure ECG recording.|Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days
16216457|NCT01265745|Drug|Normal Saline for Injection|Equivalent amounts to subjects weight, once over 120 minutes
16216458|NCT01265745|Biological|MDX1303|a sterile solution at a protein concentration of 25 mg/mL: 20 mM sodium citrate, 50 mM sodium chloride, 3.0% mannitol, 50 µM diethylenetriamine pentacetic acid and 0.06% polysorbate 80 at pH 6.5. A tubular, clear glass vial, filled with a 5 mL dose of colorless to pale yellow solution. The vial is sealed with a 20 mm stopper and white flip-off seal.
16216459|NCT01265732|Drug|PF-04191834|single dose, 100mg, dispersion
16216460|NCT01265732|Drug|PF-04191834|single dose, 100mg, suspension
16216461|NCT01265732|Drug|PF-04191834|single dose, 300mg, suspension
16216462|NCT01265719|Other|No intervention other than routine medical care|Subjects continuously treated with Latanoprost for at least one month Latanoprost treatment during the study period.
16216463|NCT01265719|Other|No intervention other than routine medical care|Subjects not treated with any topical prostaglandin analogues or continuously treated with topical prostaglandin analogues for less than one month before the baseline examination, and unlikely to be treated with topical prostaglandin analogues during the study period.
16216464|NCT01265680|Drug|Erythropoietin|80.000 UI of Human Recombinant Erythropoietin and intravenous iron at time of arrival at the hospital.
16216465|NCT01265667|Drug|CF101|orally q12h
16216466|NCT01265667|Drug|Placebo|orally q12h
16216467|NCT01265641|Drug|AZD1981, 2000mg|Single oral dose, tablets
16216468|NCT01265641|Drug|AZD1981, 200mg|Single oral dose, tablets
16216469|NCT01265641|Drug|Moxifloxacin, 400mg|Single oral dose, capsule
16216470|NCT01265641|Drug|Placebo|Single oral dose, tablets
16216471|NCT01265628|Procedure|perimetry|automated static perimetry with adapted GATE strategy
16216472|NCT01265615|Drug|Paricalcitol|paricalcitol group (6-8 μg daily per os - orally - without special diet)
16216473|NCT01265615|Drug|Calcitriol|calcitriol group (2-4 μg daily orally under with dietary restrictions of vitamin D)
16216475|NCT01265615|Dietary Supplement|Supplemental|intake of cholecalciferol in food and multivitamins, less than 400-900 IU per day
16216476|NCT01265602|Drug|LAS41007|Topical gel, to be applied twice daily (mornings and evenings), for up to 90 days. Generally 0.5 g gel (pea-sized amount of gel) per application will be sufficient to cover an overall area of 25 cm².
16216477|NCT01265602|Drug|LASW1510|Topical gel, to be applied twice daily (mornings and evenings), for up to 90 days. Generally 0.5 g gel (pea-sized amount of gel) per application will be sufficient to cover an overall area of 25 cm².
16216478|NCT01265602|Drug|vehicle of LAS41007|Topical gel, to be applied twice daily (mornings and evenings), for up to 90 days. Generally 0.5 g gel (pea-sized amount of gel) per application will be sufficient to cover an overall area of 25 cm².
16216479|NCT01265589|Drug|surfactant|Intratracheal Surfactant Administration without Vitamin A for Newborn Respiratory Distress Syndrome
16216480|NCT01265589|Drug|surfactant+vitamin A|Intratracheal Surfactant Administration with Vitamin A for Newborn Respiratory Distress Syndrome
16216481|NCT01265576|Drug|Sorafenib|Participants will be on sorafenib at least 30 days before randomization into either the Treatment or Control Arms. Sorafenib will be administered according to the package insert unless contraindicated based on physician expertise.
16216482|NCT01265576|Drug|VT-122 (propranolol plus etodolac)|Participants randomized to the VT-122 regimen (sorafenib plus VT-122) will receive oral doses of propranolol and etodolac, which will be titrated over a period of 3 weeks until the participant reaches a maximum tolerated dose (MTD)[no higher than 60 mg propranolol, twice daily (BID)/300 mg etodolac, BID]. Once the individual MTD has been reached, participants will enter a Maintenance Treatment period, and will receive the VT-122 regimen (propranolol and etodolac, co administered orally) on a continuous BID dosing schedule for a maximum of twelve 4-week cycles.
16216483|NCT01265576|Drug|Placebo|Participants randomized to the Control Arm (sorafenib with placebo) will receive placebo for the same periods as participants randomized to the Treatment Arm. Participants in the Control Arm will undergo the same visits and mock dose escalation.
16216484|NCT01265563|Drug|N-acetylcysteine placebo and silibin placebo|Dietary Supplement: N-acetylcysteine placebo excipient and silibin placebo orally twice daily for three months
16216485|NCT01265563|Drug|N-acetylcysteine active and silibin placebo|Dietary Supplement: N-acetylcysteine 600 mg orally twice daily and silibin placebo orally twice a day for three months
16216486|NCT01265563|Drug|N-acetylcysteine placebo and silibin active|Dietary Supplement: silibin 480 mg orally twice daily and N-acetylcysteine placebo orally twice a day for three months
16216487|NCT01265563|Drug|N-acetylcysteine active and silibin active|Dietary Supplement: N-acetylcysteine 600 mg orally twice daily and silibin 480 mg orally twice daily for three months
16216488|NCT01265563|Drug|N-acetylcysteine active + high-dose silibin active|Dietary Supplement: N-acetylcysteine 600 mg orally twice daily and silibin 960 mg orally twice daily for three months
16216489|NCT01265550|Device|Nissen fundoplication|laparoscopic antireflux surgery
16216490|NCT01265550|Drug|baclofen|"Baclofen will be prescribed in a dose of 5 mg three times a day (TID) with meals.
~The dose of baclofen will be increased by 5 mg TID every week until a total dose of 20 mg TID has been achieved."
16216491|NCT01265550|Drug|Desipramine|Dose of 25 mg at bedtime (HS) for 1 week, then 50 mg HS for 1 week, then 100 mg HS until the next quarterly visit.
16216492|NCT01265537|Drug|Tacrolimus|"Low target tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
~Table 1
~Months post tx:
~0-1 month, level 5-7; 1-3 months, level 4-5; and 3-6 months, level 3-4"
16216493|NCT01265537|Drug|Tacrolimus|"Standard dose of tacrolimus Advagraf (0.25mg/kg) orally once daily dosed as per manufacturer's recommendation to target trough levels as per Table 1
~Table 1
~Months post tx
~0-1 month; level 8-12; 1-3 months, level 6-9; and 3-6 months, level 5-8."
16216494|NCT01265524|Drug|CLP|Oral administration
16216495|NCT01265524|Drug|Placebo|Oral administration
16216496|NCT01265511|Drug|Placebo|Oral tablets given bid for 28 days
16216497|NCT01265511|Drug|SCY-635|SCY-635 tablets, 300 mg bid for 28 days
16216498|NCT01265511|Drug|Pegasys|180 ug prefilled syringe given once per week for up to 48 weeks
16216499|NCT01265511|Drug|Copegus|tablets given bid for up to 48 weeks
16216500|NCT01265498|Drug|obeticholic acid|25 mg daily for 72 weeks
16216501|NCT01265498|Drug|placebo|placebo capsule, 25 mg daily for 72 weeks
16216502|NCT01265485|Drug|coated suppository|Dose escalating study
16216503|NCT01265459|Device|Durolane 3 ml, Durolane 4,5 ml, Durolane 6 ml|Durolane is an intraarticular hyaluronic acid preparation
16216504|NCT01265446|Drug|Lidocaine 8mg + CPC 2mg|one single dose
16216505|NCT01265446|Drug|Lidocaine 1mg + CPC 2mg|one single dose
16216506|NCT01265433|Biological|WT-1-vaccine Montanide + GM-CSF|Patients will receive 6 injections over 12 weeks. Treatment will be administered on weeks 0, 2, 4, 6, 8, and 10. All patients will receive Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 and -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) on day -2 if they have been appropriately instructed on SQ injection administration. Patients will be informed of the expected reactions such as irritation at the injection site. Patients will keep a logbook noting the time and placement of the injection. Patients will also receive 1.0 ml of emulsion with Montanide alone or with WT-1 peptides plus Montanide. It will be administered by a nurse (it may not be self administered) subcutaneously to the same anatomical site as the GM-CSF. This site will be marked by the patient or treating healthcare professional by a permanent marker pen.
16216507|NCT01265433|Biological|Montanide adjuvant + GM-CSF (This arm is closed)|Patients will receive 6 injections over 12 weeks. Treatment will be administered on weeks 0, 2, 4, 6, 8, and 10. All patients will receive Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 and -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) on day -2 if they have been appropriately instructed on SQ injection administration. Patients will be informed of the expected reactions such as irritation at the injection site. Patients will keep a logbook noting the time and placement of the injection. Patients will also receive 1.0 ml of emulsion with Montanide alone or with WT-1 peptides plus Montanide. It will be administered by a nurse (it may not be self-administered)subcutaneously to the same anatomical site as the GM-CSF. This site will be marked by the patient or treating healthcare professional by a permanent marker pen.
16216508|NCT01265420|Biological|Injectable clostridial collagenase|Injection of 0.58mg clostridial collagenase into Dupuytren's cord, up to three injections
16216509|NCT01265394|Drug|[18F] Flutemetamol|Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
16216510|NCT01265368|Biological|MGN1601|Genetically modified allogeneic (human) tumor cells for the expression of IL-7, GM-CSF, CD80 and CD154, in fixed combination with a DNA-based double stem loop immunomodulator (dSLIM)
16216511|NCT01265355|Dietary Supplement|Anti-rotavirus protein|11mg ARP In 1 Gm Product Daily For 12 Months, given in orange juice
16216512|NCT01265355|Dietary Supplement|Maltodextrin|Maltodextrin 1 gm daily
16216513|NCT01265342|Drug|Beclomethasone|Beclomethasone nebulised suspension 400 micrograms twice a day for 10 days
16216514|NCT01265342|Drug|Placebo|Placebo nebulised suspension twice a day for 10 days
16216515|NCT01265329|Other|Negative selection|Sperm selection to continue the treatment with healthy sperm
16216516|NCT01265316|Device|There is no intervention for this study.|There is no intervention for this study. The pre-NSR IDE for this study is simply a modification to allow for recording of data without intervention.
16216517|NCT01265303|Device|Prolonged telemetric Full Disclosure ECG recording.|Continuous Full Disclosure Telemetric ECG monitoring lasting 14 days
16216518|NCT01265290|Device|repeated 24 hours ECG Holter monitoring|repeated 24 hours ECG Holter monitoring
16216519|NCT01265290|Device|Telemetric ECG monitoring|Telemetric ECG full disclosure monitoring with GSM technology
16216520|NCT01265264|Drug|ulodesine|Oral dose administered daily for 84 days.
16216521|NCT01265264|Drug|Placebo|Oral dose administered daily for 84 days.
16216522|NCT01265251|Device|Computerized neuropsychological test|Computerized neuropsychological test battery.
16216523|NCT01265251|Other|Conventional neuropsychological test|Conventional neuropsychological test (paper and pen)
16216524|NCT01265199|Drug|AT-406 in combination with daunorubicin and cytarabine|Oral AT-406 (capsule) given once daily on days 1-5 of induction therapy with daunorubicin 90 mg/m2 I.v. on days 1-3 and cytarabine 100 mg/m2 i.v. by continuous infusion on days 107 of induction therapy.
16216525|NCT01265186|Device|Bispectral Index|The Bispectral-Index is continuously recorded for up to 72 hours in the group of ventilated newborns. Every 15 minutes, a value that was generated by averaging the BIS values of the last 15 minutes will be recorded (automatically calculated by the software of the readout device). The Bispectral-Index is continuously recorded for a minimum of 4 hours in the controls.
16216526|NCT01265186|Device|Amplitude-integrated EEG|A aEEG is recorded once daily for a minimum of four hours in the group of ventilated newborns. In Controls an aEEG is recorded once for a minimum of four hours.
16216527|NCT01265173|Drug|Cefotaxime|3 g
16216528|NCT01265173|Drug|Ceftriaxone|2 g
16216529|NCT01265173|Drug|Ciprofloxacin|400 mg
16216530|NCT01265147|Drug|Cisplatin|40mg/m2/w
16216531|NCT01265147|Drug|Nedaplatin|40mg/m2/w
16216532|NCT01265121|Device|Continuous positive air pressure device (CPAP)|After titrating the air pressure during a polysomnography test, a CPAP device will be applied to the patient, during the night, for three months.
16216533|NCT01265121|Other|External nasal dilator adhesive|An external nasal dilator adhesive will be given to patients. They will be applied on the nose and will be used for three months aiming to serve as a placebo for snoring and sleep apnea.
16216534|NCT01265108|Drug|Iron sucrose.|Volunteers will receive an intravenous infusion of 200 mg iron sucrose, before exposure to 8 hours of alveolar hypoxia. At the end of the exposure, pulmonary artery systolic pressure will be measured and volunteers will undertake an exercise test while breathing hypoxic gas.
16216535|NCT01265108|Drug|Normal saline|Volunteers will receive an intravenous infusion of 100 ml normal saline, before exposure to 8 hours of alveolar hypoxia. At the end of the exposure, pulmonary artery systolic pressure will be measured and volunteers will undertake an exercise test while breathing hypoxic gas.
16216536|NCT01265069|Drug|high dose dual therapy|rabeprazole 20mg qid,amoxicillin 750mg qid for 14days
16216537|NCT01265069|Drug|concomitant therapy|rabeprazole 20 mg,amoxicillin 1000 mg,metronidazole 500 mg,clarithromycin 500 mg, bid for 10 days
16216538|NCT01265056|Drug|Gabapentin|"On Study day 1: 1200mg (single dose).
~Study day 2,3: 300mg TID, 900mg daily.
~Study day 4-7: 600mg TID 1800mg* daily.
~Study day 8-11: 800mg TID 2400mg* daily [Optional increase to 2400 if pain scores are still 4 on NRS]
~Study day 11: 1200mg TID 3600mg* daily [Optional increase to 3600 if pain scores are still >4 on NRS]
~* May revert back to prior dose if adverse symptoms occur and are thought to be drug related. Up titration then will be preformed in 48 hours following deexcalation."
16216539|NCT01265056|Drug|Placebo|Sugar Pill is administered similar to the protocol used for the investigational drug.
16216540|NCT01265043|Other|Oral hygiene intervention|Oral health promotion intervention
16216541|NCT01265030|Drug|Sirolimus|"Loading dose of 12 milligrams/meter2; Per Os (PO), by mouth day 1 (Max dose 12 milligrams)
~Starting 24 hours after the initial loading dose, patients will receive a dose of 4 milligrams/meter2 daily; Per Os (PO), by mouth days 2 through 28 (Max dose 4 milligram/day)"
16216542|NCT01265017|Drug|Estradiol, medroxyprogesterone, hydrocortisone, GH|"Estradiol 1mg every 8 hours administered orally
~Medroxyprogesterone 2.5 mg every 24 hours administered orally
~Hydrocortisone 2.5 mg every morning, 1.25 mg every afternoon, and 1.25 mg at bedtime administered orally
~Growth hormone 2 mg once a day administered by subcutaneous injection,"
16216543|NCT01265017|Drug|Matching placebo|matching placebo
16216544|NCT01265004|Procedure|Stitches|Surgical treatment of a rupture of the achilles tendon, in which both end are fastened with a U-forming stitching
16216545|NCT01265004|Procedure|Fibrin-glue|Surgical treatment, in which both ends are glued together using a medical fibrin-containing glue
16216546|NCT01265004|Procedure|Stitches and Fibrin-glue|Surgical treatment, in which both ends of the ruptured tendon are fastened together with u-forming stitches as well as fibrin-glue
16216575|NCT01264770|Drug|Adalimumab and placebo of fostamatinib|Adalimumab 40mg injection once every two weeks and placebo to fostamatinib twice daily.
16216576|NCT01264770|Drug|Placebo of fostamatinib, fostamatinib, and placebo injections|Placebo injection once every two weeks. Placebo to fostamatinib for six weeks, followed by fostamatinib 100mg twice daily (Group F) / fostamatinib 100mg twice daily then 150mg once daily (Group G).
16216577|NCT01264757|Behavioral|Physical Activity Educational Materials|A brochure was provided to participants about the health benefits of physical activity and physical activity recommendations
16216657|NCT01264198|Behavioral|Resistance Training|Supervised Resistance Training
16216547|NCT01264991|Procedure|Arthroscopic partial meniscectomy|The arthroscopic partial meniscectomy will be performed on an outpatient basis by experienced surgeons at a level of at least attending physicians or at the last year of residency. All arthroscopies will be performed in general anaesthesia combined with local anaesthesia. After general anaesthesia is induced, the knee will be examined for stability. Thereafter two standard portals on the lateral and medial side of the ligamentum patella will be created but no outflow cannula inserted. An arthroscope will be used with a pressure-controlled irrigation system. Tourniquet use will be according to surgeon preference. The strategy for the meniscectomy will be to preserve as much tissue as possible. A standard operation protocol will be used to document possible findings in cartilage, ligaments, synovium and the medial and lateral meniscus. Meniscus lesions and type of will be registered and changes in the articular cartilage will be classified according to the ICRS classification
16216548|NCT01264991|Procedure|Sham procedure|The placebo procedure will be performed under the same conditions as above. The patient will be fully sedated in general anaesthesia. As above, the stability of the knee will be examined. Local anaesthetic will be applied as above and 2 skin incisions will be made at the same location and the same size as above. Then the knee will be manipulated as if a real arthroscopy were being done, the spillage of water and all the other equipment needed for an arthroscopy will be used and manipulated. No instruments will enter the portals for arthroscopy to avoid the possibility of osteochondral lesions and unwanted interventions by the surgeon.
16216549|NCT01264978|Device|Repetitive magnetic stimulation of the quadriceps muscle|"During 8 weeks, 7-10 days after hospital release, patients will receive repetitive magnetic stimulation sessions, 15 minutes on each thigh, alternatively two and three days /week.
~Coil location: centered on the union between upper and lower two thirds of the vastus lateralis.
~Stimulation bursts at 10-7 HZ lasting 2 seconds, followed by 4 seconds rest. Intensity will be from 40 to 70% of maximal output, adjusting frequency so that the coil does not overheat, (more than 41ºC).
~Coils are cooled down to 5ºC before sessions."
16216550|NCT01264965|Drug|long acting oxycodone|10mg twice daily
16216551|NCT01264965|Drug|extra strength acetaminophen|1,000 mg twice daily
16216552|NCT01264952|Procedure|Electrochemotherapy|"Treatment procedure: anesthesia, positioning of electrodes, intravenous in bolus administration of bleomycin (15 mg/m2), within 5-30 min after administration of bleomycin application of electric pulses (8 pulses, duration 100 microseconds, frequency 4 Hz with amplitude adequate to cover the whole treated lesion with electric field necessary for reversible plasma membrane permeabilization), removal of electrodes.
~The maximum duration of procedure is 90 minutes."
16216553|NCT01264939|Drug|Omalizumab|Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial.
16216554|NCT01264939|Drug|Placebo|Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug.
16216555|NCT01264939|Drug|H1 antihistamine, H2 antihistamine, leukotriene receptor antagonist|Participants were required to maintain stable doses of their pre-randomization combination therapy with an H1 antihistamine and either an H2 blocker or leukotriene receptor antagonist, or all 3 drugs in combination, throughout the 24-week treatment period and 16-week follow-up period of the 40-week study.
16216556|NCT01264939|Drug|Diphenhydramine|Participants were provided with diphenhydramine 25 mg for itch relief on an as-needed basis, up to a maximum of 3 doses within 24 hours for the duration of the 40-week study.
16216557|NCT01264913|Behavioral|sleep extension & circadian alignment|Both groups of workers will undergo a 1-week period of fixed bedtimes, light-dark cycles and mealtimes in the laboratory to pay the sleep debt and align the circadian system
16216558|NCT01264900|Behavioral|Psychotherapy|Twelve weekly 50-minute sessions of individual cognitive behavioral aggression treatment or supportive psychotherapy
16216559|NCT01264887|Drug|Tapentadol Prolonged Release|Titration to achieve sufficient pain relief to continue with effective analgesia for as long as the participant tolerates and wishes to continue treatment.
16216560|NCT01264874|Drug|Vitamin D3 ( Colecalciferol)|100000 IU every 50 days for 3 years
16216561|NCT01264874|Other|placebo|For 3 years IU every 50 days
16216562|NCT01264861|Drug|Safinamide|"Safinamide 100 mg/day = two 50 mg tablets administered orally, once a day, in the morning, with or without food.
~Safinamide 200 mg/day = four 50 mg tablets administered orally, once a day, in the morning, with or without food; this will be preceded by a three day titration of 150 mg = three 50 mg tablets administered orally, once a day, in the morning, with or without food.
~Safinamide 300 mg/day = six 50 mg tablets administered orally, once a day, in the morning, with or without food; this will be preceded by a three day titration of 250 mg = five 50 mg tablets administered orally, once a day, in the morning, with or without food."
16216563|NCT01264848|Procedure|balloon angioplasty and/or stenting|balloon angioplasty and/or stenting of internal jugular veins and/or azygous vein and/or brachiocephalic veins
16216564|NCT01264848|Procedure|balloon angioplasty and/or stenting|balloon angioplasty and/or stenting of extracranial vein draining the central nervous system, on condition that such outflow pathology has been confirmed using catheter venography
16216565|NCT01264835|Device|Slotted Anoscope|SA411
16216566|NCT01264822|Drug|Rabeprazole Sodium|"The following 3 drugs are taken orally at the same time twice daily for 7 days: rabeprazole sodium 10 mg, amoxicillin hydrate 750 mg, and clarithromycin 200 mg.
~The dose of clarithromycin may be properly increased as needed, although the upper limit is 400 mg twice daily.
~If Helicobacter pylori eradication with proton pump inhibitor, amoxicillin, and clarithromycin fails, the following 3 drugs will be taken at the same time twice daily for 7 days as an alternative treatment for adults: rabeprazole sodium 10 mg, amoxicillin hydrate 750 mg, and metronidazole 250 mg."
16216567|NCT01264809|Behavioral|Specific consultation for physical activity counseling|Specific consultation
16216568|NCT01264809|Behavioral|Consultation for physical activity counseling|Specific consultation
16216569|NCT01264796|Behavioral|culturally tailored diabetes education|lifestyle modification group education
16216570|NCT01264783|Drug|RNS60|RNS60 for intravenous administration
16216571|NCT01264783|Drug|Placebo|0.9% normal saline for injection
16216572|NCT01264770|Drug|Fostamatinib and placebo injections|Fostamatinib 100mg twice daily and placebo injection once every two weeks
16216573|NCT01264770|Drug|Fostamatinib and placebo injections|Fostamatinib 100mg twice daily / fostamatinib 150mg once daily and placebo injection once every two weeks
16216574|NCT01264770|Drug|Fostamatinib and placebo injections|Fostamatinib 100mg twice daily / fostamatinib 100mg once daily and placebo injection once every two weeks.
16216578|NCT01264757|Behavioral|Pedometer|A pedometer was provided to participants in addition to educational materials about the health benefits of physical activity.
16216579|NCT01264731|Biological|MELITAC 12.1|Vaccine regimen: The vaccines will be administered in two treatment cycles. During cycle one, three vaccines will be administered over a 3-week period on days 1, 8, and 15. During cycle two, three vaccines will be administered over a 9-week period on days 36, 57, 78. Participants in cohort 1 will receive MELITAC 12.1 (100 mcg each of the12-MP and 200 mcg of Peptide-tet) administered subcutaneously (1 ml) and intradermally (1 ml) in Montanide ISA-51 VG adjuvant at a single vaccination site.
16216580|NCT01264731|Drug|Imiquimod|Topical Imiquimod regimen: Beginning on day 1, patients in cohorts 1 and 2 will have one or more cutaneous melanoma metastases treated topically with 5% imiquimod cream, with a dose of 1 to 3 packets of imiquimod daily, (depending on the extent of cutaneous metastases). Each packet contains 250 mg of cream and may be used for a surface area of up to 20 cm2. The number of lesions that are treated will be dependent on the availability and size of the lesions. In addition, if available, at least two lesions will be followed without treatment with the plan that they will be excised at week 3 (day 22) and week 6 (day 43), respectively, as controls. Imiquimod will be applied daily for seven days each week for 12 weeks. One course of treatment will be three weeks in duration, with evaluation by a clinician after every treatment course.
16216581|NCT01264718|Behavioral|Parent Mentors|After random assignment to the Parent Mentor group, minority low-income parents of Medicaid/CHIP eligible children met with Parent Mentors to receive instruction and help on completing, submitting applications for, and maintaining Medicaid/CHIP coverage for their child.
16216582|NCT01264705|Drug|bavituximab (0.3 mg/kg) and sorafenib|Bavituximab:0.3 mg/kg weekly Sorafenib: 400mg PO twice daily
16216583|NCT01264705|Drug|bavituximab (1.0 mg/kg ) and sorafenib|Bavituximab: 1.0 mg/kg weekly Sorafenib: 400mg PO twice daily
16216584|NCT01264705|Drug|bavituximab (3.0 mg/kg) and sorafenib|Bavituximab: 3.0 mg/kg weekly Sorafenib: 400mg PO twice daily
16216585|NCT01264692|Drug|ACT-280778|10 mg once daily for 28 ± 2 days
16216586|NCT01264692|Drug|Placebo|Placebo oral capsules matching ACT-280778
16216587|NCT01264692|Drug|Amlodipine|10 mg once daily for 28 ± 2 days
16216588|NCT01264679|Drug|Ferumoxytol|IV Ferumoxytol
16216589|NCT01264666|Dietary Supplement|Chinese tea flavor liquor|60 mL of Chinese tea flavor liquor (45% alcohol content) is consumed with high-fat meal.
16216590|NCT01264666|Dietary Supplement|Chinese Meijiao liquor|
16216591|NCT01264666|Dietary Supplement|Water control|
16216592|NCT01264653|Drug|adrenalin|adrenalin 0.01%
16216593|NCT01264640|Drug|Aspirin and Clopidogrel|Intake of 500 mg Aspirin on day 1. Intake of 600 mg Clopidogrel on day 28. Blood collection for the measurement of platelet inhibition, platelet counts and BDNF, TGF-beta, 5-HT concentrations in peripheral blood on day 1 (before intake of 500 mg Aspirin), day 2 (24 hours after intake of 500 mg Aspirin), day 28 (before intake of 600 mg Clopidogrel), day 29 (24 hours after intake of 600 mg Clopidogrel).
16216594|NCT01264627|Behavioral|Mindful Breathing (MB) Intervention|"The Mindful Breathing (MB)intervention is based on MBSR developed by Jon Kabat-Zinn. Participants will attend 8 individual weekly MB sessions. MB consists of closely following the breath, throughout inhalation and exhalation, sustaining moment-to-moment awareness on the breathing process, and passively observing thoughts, affective states, from a non-evaluative or judgmental perspective. As attention wanders to concerns or thoughts, participants will be instructed to acknowledge and accept these without evaluation and return the focus of attention back to breathing. Participants in MB will have their breathing rate and PetCO2 monitored during the 8 training sessions with a breathing monitor."
16216595|NCT01264627|Behavioral|Usual Care (UC) Control Condition|"This control intervention is designed to account for the effects of nonspecific factors such as enrollment in a study to enhance health with the associated expectancy effects, staff attention, and measurement procedures including the monitoring of PetCO2 and (Blood Pressure) BP, and completion of questionnaires. Participants who are randomly assigned to the Usual Care condition will receive care as usual for the management of their prehypertensive condition. UC participants will receive their usual care and have access to all Kaiser Permanente (KP) health education resources, such as KP's interactive healthcare guide, and online Healthy Lifestyle Programs. We will assess the extent to which participants in both MB and UC used these resources."
16216596|NCT01264614|Behavioral|Strengthening exercise|3 months of 3-5 times per week of low-intensity exercises using a chair and small weights
16216597|NCT01264601|Biological|Trivalent Influenza Vaccine|Age appropriate dose of seasonal Trivalent Influenza Vaccine (TIV), either 0.25mL under age 3 or 0.5mL over the age of 3.
16216598|NCT01264588|Other|Topical calcium glycerophosphate lotion|2g once daily for 6 weeks (post-op day 3 thru 42)
16216599|NCT01264575|Drug|intrathecal bupivacaine 6 mg with 100 mcg of epinephrine|intrathecal bupivacaine 6 mg with 100 mcg of epinephrine
16216600|NCT01264575|Drug|intrathecal bupivacaine 7 mg with 100 mcg of epinephrine|intrathecal bupivacaine 7 mg with 100 mcg of epinephrine
16216601|NCT01264575|Drug|intrathecal bupivacaine 8 mg with 100 mcg of epinephrine|intrathecal bupivacaine 8 mg with 100 mcg of epinephrine
16216602|NCT01264575|Drug|intrathecal bupivacaine 9 mg with 100 mcg of epinephrine|intrathecal bupivacaine 9 mg with 100 mcg of epinephrine
16216603|NCT01264575|Drug|intrathecal bupivacaine 10 mg with 100 mcg of epinephrine|intrathecal bupivacaine 10 mg with 100 mcg of epinephrine
16216604|NCT01264575|Drug|intrathecal bupivacaine 11 mg with epinephrine 100 mcg|intrathecal bupivacaine 11 mg with epinephrine 100 mcg
16216605|NCT01264575|Drug|intrathecal bupivacaine 6 mg with 200 mcg of epinephrine|intrathecal bupivacaine 6 mg with 200 mcg of epinephrine
16216606|NCT01264575|Drug|intrathecal bupivacaine 7 mg with 200 mcg of epinephrine|intrathecal bupivacaine 7 mg with 200 mcg of epinephrine
16216607|NCT01264575|Drug|intrathecal bupivacaine 8 mg with 200 mcg of epinephrine|intrathecal bupivacaine 8 mg with 200 mcg of epinephrine
16216608|NCT01264575|Drug|intrathecal bupivacaine 9 mg with 200 mcg of epinephrine|intrathecal bupivacaine 9 mg with 200 mcg of epinephrine
16216609|NCT01264575|Drug|intrathecal bupivacaine 10 mg with 200 mcg of epinephrine|intrathecal bupivacaine 10 mg with 200 mcg of epinephrine
16216610|NCT01264575|Drug|intrathecal bupivacaine 11 mg with 200 mcg of epinephrine|intrathecal bupivacaine 11 mg with 200 mcg of epinephrine
16216656|NCT01264211|Drug|Placebo|Week 0 to Week 4: Diacerein 50 mg daily for 4 weeks Week 4 to Week 24: Diacerein 100 mg daily for 20 weeks
16216611|NCT01264549|Device|Procalcitonin assay - B.R.A.H.M.S PCT ultrasensitive Kryptor|The physician will be given access to a PCT value for Day 1 - 7. Depending on the PCT concentrations, the protocol recommends or discourages from the use of antibiotics
16216612|NCT01264536|Dietary Supplement|lactoferrin|Infants will receive oral bovine lactoferrin (200 mg/Kg/day divided in three dosis) for 4 weeks. Lactoferrin will be dissolved in human milk or infant formula or in a 5% glucose solution. Each dose will be dissolved in a small volume so the maximum lactoferrin concentration will be 25mg/mL.
16216613|NCT01264536|Dietary Supplement|Maltodextrin|Infants will receive oral maltodextrin (200mg/Kg/day in three divided dosis) for 4 weeks. Maltodextrin will be dissolved in human milk or infant formula or in a 5% glucose solution. Each dose will be dissolved in a small volume so the maximum maltodextrin concentration will be 25mg/mL.
16216614|NCT01264523|Other|Chronologically scheduled snacking with 40-30-30 products|Short-term analysis of the effects of the substitution of the habitual breakfast, mid-morning and afternoon snack of type-2 diabetes patients by 40-30-30 products. Longitudinal 2-period study
16216615|NCT01264510|Other|audiological test battery|routine audiological measurements.
16216616|NCT01264497|Drug|TH9507|1 and 2 mg, sc daily for 12 weeks
16216617|NCT01264484|Device|Advantage Prosthetic Heart Valve|All patients eligible for this study are treated with an Advantage prosthetic heart valve
16216618|NCT01264471|Procedure|Skin biopsy|A small skin sample will be obtained from the patients arm which is approximately the size of the top of a thumbtack (a small circle no more than a 1/4 inch across)
16216619|NCT01264471|Procedure|Blood Collection|Approximately 45ml or 3 tablespoons for blood will be drawn from a vein in the patient's forearm.
16216620|NCT01264445|Biological|Adjuvanted GSK investigational HIV vaccine formulation 1|Receive at Months 0 and 1
16216621|NCT01264445|Biological|Adjuvanted GSK investigational HIV vaccine formulation 2|Receive at Months 0 and 1
16216622|NCT01264445|Biological|Ad35 investigational HIV vaccine|Receive at Month 0
16216623|NCT01264445|Biological|Adjuvanted GSK investigational HIV vaccine formulation 2|Receive at Months 3 and 4
16216624|NCT01264445|Biological|Adjuvanted GSK investigational HIV vaccine formulation 2|Receive at Months 0, 1, and 4
16216625|NCT01264445|Biological|Ad35 investigational HIV vaccine|Receive at Month 4
16216626|NCT01264445|Biological|Ad35 investigational HIV vaccine|Receive at Months 0, 1, and 4
16216627|NCT01264445|Biological|Placebo (saline)|(Vaccine:Placebo=28:7) Groups A, B, C, and D will all have a placebo comparator component (7 volunteers will receive placebo in each group at the specified months.)
16216628|NCT01264432|Other|Laboratory Biomarker Analysis|Correlative studies
16216629|NCT01264432|Other|Quality-of-Life Assessment|Ancillary studies
16216630|NCT01264432|Radiation|Radiation Therapy|Undergo LDFWAR
16216631|NCT01264432|Drug|Veliparib|Given PO
16216632|NCT01264419|Device|Silk Road Embolic Protection System|System that delivers a carotid artery stent, via transcervical access using reverse flow cerebral protection, as treatment for high-grade extracranial carotid artery disease
16216633|NCT01264393|Behavioral|Shape Up Rhode Island + Online Resources|Participants will receive Shape Up Rhode Island, which is a 12-week statewide physical activity and weight loss campaign in addition to online weight loss resources
16216634|NCT01264393|Behavioral|Shape Up Rhode Island + Online Weight Loss Program|Participants will receive Shape Up Rhode Island, a 12-week statewide physical activity and weight loss campaign in addition to an online weight loss program
16216635|NCT01264393|Behavioral|Shape Up Rhode Island + Online Weight Loss Program + Group sessions|Participants will receive Shape Up Rhode Island, a 12-week statewide physical activity and weight loss campaign in addition to an online weight loss program and the option of attending group sessions
16216636|NCT01264380|Drug|RO5185426|Single oral dose, fasted
16216637|NCT01264380|Drug|RO5185426|Single oral dose, with high fat meal
16216638|NCT01264380|Drug|RO5185426|Continuous administration, orally twice daily
16216639|NCT01264367|Drug|Clevudine|30mg,QD
16216640|NCT01264367|Drug|Clevudine + Peg-interferon|30mg, QD(for 24 weeks) + 180mcg,QW(for 24 weeks)
16216641|NCT01264354|Drug|Clevudine 30mg|Clevudine 30mg
16216642|NCT01264354|Drug|Clevudine 20mg+Adefovir dipivoxil 10mg|Clevudine 20mg+ Adefovir 10mg
16216643|NCT01264354|Drug|Clevudine 20mg|Clevudine 20mg
16216644|NCT01264341|Drug|Bevacizumab|Bevacizumab 10mg/kg intravenous every 2 weeks until disease progression, unacceptable toxicity or consent withdrawal.
16216645|NCT01264341|Drug|Temsirolimus|Temsirolimus 25mg intravenous once weekly until disease progression, unacceptable toxicity or consent withdrawal.
16216646|NCT01264328|Drug|Panitumumab + paclitaxel|Paclitaxel 80 mg/m2 may be infused, intravenously, over one hour every week. Panitumumab will be administered every 2 weeks at a dose of 6 mg/kg, using a non pyrogenic low protein binding filter with a 0.20-0.22-μm pore size intravenously over 1 hour ± 15 minutes. Panitumumab will be administered prior to paclitaxel.
16216647|NCT01264315|Drug|Lenalidomide|"Lenalidomide will be started at 6 months post-allotransplant at 10 mg/day continuously in all patients:
~absolute neutrophil count >1x109/L without growth factors
~platelet count >75x109/L without transfusion support
~calculated/measured creatinine clearance: ≥20mL/minute
~total bilirubin <2 x the upper limit of normal
~AST (SGOT) and ALT (SGPT) <2.5 x upper limit of normal
~<1mg/kg/day of prednisone, and no more than 2 immunosuppressive drugs other than steroid to control GVHD
~Treatment will be continued without interruption, unless not tolerated, until unacceptable adverse events or progressive disease occur. In case of disease progression occurring before the start of lenalidomide, the patient will be withdrawn from study and treated according to the center preference. Lenalidomide will be discontinued in patients achieving and maintaining molecular remission for 2 consecutive controls at least 6 weeks apart."
16216648|NCT01264302|Drug|Finasteride|Finasteride Tablets 5 mg
16216649|NCT01264289|Drug|Finasteride|Finasteride Tablets 5 mg
16216650|NCT01264250|Drug|AZD2927|Single dose of AZD2927
16216651|NCT01264250|Drug|Placebo|Single dose of placebo
16216652|NCT01264237|Drug|Etoricoxib|90mg Tablet QD at 10:00a.m.
16216653|NCT01264237|Drug|Placebo|One tablet QD at 10:00a.m.
16216654|NCT01264224|Drug|PAC-14028|tablets, oral administration, single/multiple dosing, dose escalation
16216655|NCT01264211|Drug|Diacerein|Week 0 to Week 4: Diacerein 50 mg daily for 4 weeks Week 4 to Week 24: Diacerein 100 mg daily for 20 weeks
16216658|NCT01264172|Procedure|PCCP|PCCP: an minimal-invasive surgery technique, in wich a special plate is pushed in position and fixed through 2 small approaches only (about 2 cm long)
16216659|NCT01264172|Procedure|DHS|Conventional surgical treatment of proximal femur fracture including one longer approach from lateral
16216660|NCT01264172|Procedure|Osteosynthesis with nails|Osteosynthesis with nails is a minimal-invasive surgery technique for proximal femur fractures.
16216661|NCT01264159|Device|Lung impedence-guided therapy|
16216662|NCT01264159|Other|Usual treatment of patients with developing acute heart failure|
16216663|NCT01264146|Procedure|HBOT|Open reduction and internal fixation of calcaneal fracture + hyperbaric oxygen therapy 20 postoperative days (one time, 90 minutes a day)
16216664|NCT01264146|Procedure|Placebo (Sham)|open reduction and internal fixation of calcaneal fracture + Placebo (Sham)
16216665|NCT01264133|Drug|Clevudine, Adefovir|Clevudine 30mg qd or Clevudine 30mg + Adefovir 10mg qd
16216666|NCT01264120|Behavioral|Health Psychology Intervention|The health psychology intervention will involve a bariatric rehabilitation service (BRS) which will involve those allocated to the intervention receiving usual care plus three 50 minute sessions with a health psychologist pre-operatively (1 week before surgery), perioperatively (before they are discharged from hospital) and at 3 month follow up.
16216667|NCT01264094|Drug|Clevudine|clevudine 30 mg qd
16216668|NCT01264081|Drug|Lapatinib|500 mg PO (orally) twice a day for 28 days (1 cycle). Up to 27 cycles allowed if response seen.
16216669|NCT01264068|Drug|Finished Herbal Product such as Suan Tsao Jen Tang, Jia-Wey Shiau-Yau San|Take medicine every day 3 times, each time 4 grams.
16216670|NCT01264042|Dietary Supplement|Ferrous Sulfate|60 mg with 200 mL water, single administration
16216671|NCT01264029|Behavioral|Mindful Tai Chi Intervention|
16216672|NCT01264029|Behavioral|Mindfulness Meditation|
16216673|NCT01264029|Behavioral|Mall Walking|
16216674|NCT01264029|Behavioral|Weekly Discussion|
16216675|NCT01264016|Device|Investigational Blood Glucose Monitoring System|Untrained subjects with diabetes performed Blood Glucose (BG) tests with subject's capillary fingerstick using the investigational Tradewind meter and investigational sensor. Study staff tested subject venous blood. All BG Results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff.
16216676|NCT01264003|Drug|sefazolin|In prophylaxis
16216677|NCT01263990|Device|NexFin|noninvasive finger cuff system
16216678|NCT01263977|Device|Picco- thermodilution catheter|Transpulmonary thermodilution and pulse contour analysis with arterial catheter Arterial access via femoral
16216679|NCT01263964|Procedure|coronary angiogram|coronary angiogram
16216682|NCT01263938|Drug|Atorvastatin|"For subjects on PI-based HAART therapy: 10mg/day X 2weeks followed by 20mg/day.
~For subjects on non PI-based HAART therapy: 20mg/day X 2weeks followed by 40mg/day."
16216683|NCT01263925|Drug|Alprostadil (Prostaglandin E1)|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of 3 ampoules (20 µg) of Prostaglandin E1 (total 60 µg) in 50 - 250 ml physiological saline solution over 2 hours.
~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of 3 ampoules (20 µg) of Prostaglandin E1 (total 60 µg) in 50 - 250 ml physiological saline solution over 2 hours."
16216684|NCT01263925|Drug|Pentoxifylline|"4-week Daily Treatment Period 1: 4 weeks of 2 x daily (including weekends) 600 mg Pentoxifylline tablets.
~4-week Interval Treatment Period 2: 4 weeks of 2 x daily (including weekends) 600 mg Pentoxifylline tablets."
16216685|NCT01263925|Drug|Placebo to Pentoxifylline oral|"4-week Daily Treatment Period 1: 4 weeks of 2 x daily (including weekends) matching Placebo to Pentoxifylline tablets.
~4-week Interval Treatment Period 2: 4 weeks of 2 x daily (including weekends) matching Placebo to Pentoxifylline tablets."
16216686|NCT01263925|Drug|Placebo to Alprostadil (Prostaglandin E1) intravenous|"4-week Daily Treatment Period 1: 4 weeks of 1 x daily intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours.
~4-week Interval Treatment Period 2: 4 weeks of 2 x weekly intravenous infusion of Placebo in 50 - 250 ml physiological saline solution over 2 hours."
16216687|NCT01263912|Dietary Supplement|LCPUFA Supplement|Children 12-13 months old will be assigned at random to receive either a nutrition supplement containing LCPUFA or a placebo until 24 months-of-age
16216688|NCT01263912|Dietary Supplement|Placebo|Children 12-13 months old will be assigned at random to receive either a nutrition supplement containing LCPUFA or a placebo until 24 months-of-age
16216689|NCT01263899|Drug|SB1518|SB1518 taken orally daily for 28 consecutive days in a 28 day cycle.
16216690|NCT01263886|Drug|ombrabulin (AVE8062)|"Pharmaceutical form:solution
~Route of administration: intravenous"
16216691|NCT01263886|Drug|placebo|"Pharmaceutical form:solution
~Route of administration: intravenous"
16216692|NCT01263873|Device|Mallinckrodt (ETT)|7.0 millimeter internal diameter for female 8.0 millimeter internal diameter for male
16216693|NCT01263873|Device|Parker Flex-Tip (ETT)|7.0 millimeter internal diameter for female 8.0 millimeter internal diameter for male
16216694|NCT01263860|Drug|Peginterferon alfa2a|patients receive a dose of 180 µg of PEGASYS once a week for 24 weeks
16216695|NCT01263860|Drug|Ribavirin|patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 24 weeks
16216696|NCT01263860|Drug|Peginterferon alfa2a|patients receive a dose of 180 µg of PEGASYS once a week for 48 weeks
16216697|NCT01263860|Drug|Ribavirin|patients receive a dose 800 to 1200 mg of ribavirin once a day(according to weight) for 48 weeks
16216698|NCT01263847|Dietary Supplement|Galactooligosaccharide|Zero, 5 or 10 g/day of galactooligosaccharide will be administered in two yogurt drinks containing about 300 mg total calcium each per day for three weeks. During a clinical visit following three weeks of consumption, zero, 2.5 or 5 g of galactooligosaccharide will be administered in the same yogurt with the addition of 15 mg Ca-44 (calcium chloride). Participants will be given one of the above yogurts at breakfast in addition to intravenously receiving 3.5 mg Ca-43 (calcium chloride) in 4 ml saline one hour after breakfast consumption.
16216699|NCT01263834|Drug|Bevacizumab|Bevacizumab injection of 1.25m/0.05 cc + Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application
16216700|NCT01263834|Drug|Mitomycin C|Mitomycin C soaked cellulose dose 0.4 mg/ml with 3 minutes of application
16216701|NCT01263821|Procedure|Diffusion-weighted magnetic resonance imaging|Undergo diffusion-weighted MRI
16216702|NCT01263821|Procedure|Perfusion-weighted magnetic resonance imaging|Undergo perfusion-weighted magnetic resonance imaging
16216703|NCT01263821|Procedure|Functional magnetic resonance imaging|Undergo functional MRI
16216704|NCT01263821|Procedure|Magnetic resonance spectroscopic imaging|Undergo MR spectroscopic imaging
16216705|NCT01263821|Procedure|Therapeutic conventional surgery|Undergo maximal surgical resection
16216706|NCT01263821|Procedure|Quality-of-life assessment|Ancillary studies
16216707|NCT01263821|Procedure|Radiation therapy treatment planning/simulation|Undergo IMRT planning
16216708|NCT01263821|Procedure|Intensity-modulated radiation therapy|Undergo intensity-modulated radiation therapy
16216709|NCT01263821|Other|Questionnaire administration|Ancillary studies
16216710|NCT01263808|Drug|Indacaterol 150 µg|Once daily (QD) via single-dose dry powder inhaler (SDDPI)
16216711|NCT01263808|Drug|Indacaterol 300 µg|QD via SDDPI
16216712|NCT01263808|Drug|Indacaterol 600 µg|QD via SDDPI
16216713|NCT01263808|Drug|Placebo|QD via SDDPI
16216714|NCT01263808|Drug|Placebo/moxifloxacin|Placebo QD via SDDPI for 14 days, followed by a single dose of moxifloxacin 400 mg
16216715|NCT01263782|Drug|Carboplatin|AUC 6 by vein on day 1 of every 21 day cycle for 4 cycles.
16216716|NCT01263782|Drug|Pemetrexed|500 mg/m2 by vein on day 1 of each 21 day cycle.
16216717|NCT01263782|Drug|Bevacizumab|15 mg/kg by vein on day 1 of each 21 day cycle.
16216718|NCT01263782|Drug|Cixutumumab|20 mg/kg by vein on day 1 of each 21 day cycle.
16216719|NCT01263769|Drug|Axitinib|Starting dose: 5 mg by mouth twice each day for 12 weeks.
16216720|NCT01263743|Behavioral|Relaxation Response|The Relaxation Response is a type of relaxation. The goal of the Relaxation Response is to consciously elicit a reaction opposite in direction to the stress response.
16216721|NCT01263743|Behavioral|Relaxation Response|Relaxation Response is a type of relaxation. This is a technique that elicits a state that is opposite to the stress response.
16216722|NCT01263730|Behavioral|Tai Chi|Tai Chi training consists of a sequence of slow, soft, and graceful movements derived from the martial arts. It is considered as a moving form of yoga and meditation combined. Tai Chi has been considered as one form of oriental healing arts, like acupuncture, which fosters the circulation of this 'chi' or energy within the body.
16216723|NCT01263717|Drug|tesamorelin|Tesamorelin (growth hormone releasing hormone) 2mg daily given by subcutaneous injection x 6 months during randomized phase, followed by 6 months of open-label tesamorelin at same dose
16216724|NCT01263717|Drug|placebo|Placebo 2mg daily given by subcutaneous injection for the first 6 months of the study, followed by an open-label phase of 6 months of tesamorelin (growth hormone releasing hormone) treatment, 2mg daily given by subcutaneous injection
16216725|NCT01263704|Drug|Cyclophosphamide|150 milligrams per square meter (mg/m^2) intravenously (IV) on Days 1-3 of each 28-day cycle for 6 cycles
16216726|NCT01263704|Drug|Fludarabine|12.5 mg/m^2 IV on Days 1-3 of every 28-day cycle for 6 cycles
16216727|NCT01263704|Drug|Rituximab|375 mg/m^2 IV Day 0 of Cycle 1, 500 mg/m^2 IV Day 1 of Cycles 2-6. Each cycle was 28 days.
16216728|NCT01263691|Biological|BioThrax|BioThrax
16216729|NCT01263691|Biological|AV7909 Formulation 1|AV7909 Formulation 1
16216730|NCT01263691|Biological|AV7909 Formulation 2|AV7909 Formulation 2
16216731|NCT01263691|Biological|AV7909 Formulation 3|AV7909 Formulation 3
16216732|NCT01263691|Biological|AV7909 Formulation 4|AV7909 Formulation 4
16216733|NCT01263691|Drug|Control|Saline control
16216734|NCT01263678|Behavioral|Coaching|Decision support coaching will be provided after the participant has viewed the decision aid
16216735|NCT01263678|Other|Usual Care|Patient views DA and completes post DA survey.
16216736|NCT01263665|Device|25 cm GORE® VIABAHN®|25 cm GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface, possibly in conjunction with an additional overlapping VIABAHN® device (2.5, 5, 10, 15, or 25 cm lengths) based on the enrolled patient's lesion length (greater than or equal to 20 cm length).
16216737|NCT01263652|Drug|Diclofenac hydroxyethylpyrrolidine|IM/PO
16216738|NCT01263652|Drug|orphenadrine|IM/PO orphenadrine
16216739|NCT01263652|Drug|Tramadol|IM/PO tramadol
16216740|NCT01263652|Drug|Dipyrone|PO/IM Dipyrone
16216741|NCT01263639|Other|Orthopaedic Attending Biosketch Card|"The intervention group will receive an attending photo/biosketch card within 24 hours of admission while the control group will not. The biosketch card will include a picture of the attending orthopaedic surgeon with a brief synopsis of his or her: education background, specialty, surgical interests, research interests, and other interests including hobbies."
16216742|NCT01263639|Other|Standard of care - No biosketch card|Standard of care
16216743|NCT01263613|Procedure|tumor biopsy and blood draw|tumor biopsy and blood draw during and after chemotherapy
16216744|NCT01263574|Drug|70% ethanol|Administration of the lock solution will occur between cycles of parenteral nutrition. Lock solutions will be administered three days per week. The pre-measured volume of lock solution will then be injected into the catheter for 4 hours. Prior to the next instillation of medications into the catheter, the lock solution will be aspirated and discarded. Another 5mL flush of saline will then be instilled into the catheter prior to medication or parenteral nutrition administration. Volume of lock solution administered will be determined by catheter size.
16216745|NCT01263561|Procedure|ExPRESS shunt|ExPRESS miniature glaucoma drainage device
16216746|NCT01263561|Procedure|trabeculectomy|trabeculectomy filtering surgery
16216747|NCT01263548|Drug|lisdexamfetamine dimesylate|Dosage form: Capsules; Dosage strength: 30-70mg/day, flexible dosing; Duration: 4 weeks
16216748|NCT01263535|Device|SENSIMED Triggerfish|Contact lens-based device for the continuous recording of IOP fluctuations, with a portable recording system
16216749|NCT01263522|Other|different training programs|two different endurance programs and one strength endurance program
16216750|NCT01263522|Other|control condition|unchanged lifestyle
16216751|NCT01263509|Drug|Alogliptin and voglibose|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
16216809|NCT01263145|Other|Laboratory Biomarker Analysis|Correlative studies
16216810|NCT01263145|Drug|Paclitaxel|Given IV
16216752|NCT01263509|Drug|Alogliptin and voglibose|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
16216753|NCT01263496|Drug|Alogliptin|Alogliptin 6.25 mg, tablets, orally, once daily for up to 40 weeks.
16216754|NCT01263496|Drug|Alogliptin|Alogliptin 12.5 mg, tablets, orally, once daily for up to 40 weeks.
16216755|NCT01263496|Drug|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for up to 40 weeks.
16216756|NCT01263496|Drug|Alogliptin|Alogliptin 50 mg, tablets, orally, once daily for up to 40 weeks.
16216757|NCT01263496|Drug|Voglibose|Voglibose 0.2 mg, tablets, orally, three times daily for up to 40 weeks.
16216758|NCT01263483|Drug|Alogliptin and voglibose|Alogliptin 12.5 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
16216759|NCT01263483|Drug|Alogliptin and voglibose|Alogliptin 25 mg, tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
16216760|NCT01263483|Drug|Voglibose|Alogliptin placebo-matching tablets, orally, once daily and voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
16216761|NCT01263470|Drug|Alogliptin|Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
16216762|NCT01263470|Drug|Alogliptin|Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
16216763|NCT01263470|Drug|Alogliptin|Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
16216764|NCT01263470|Drug|Alogliptin|Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks
16216765|NCT01263470|Drug|Voglibose|Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
16216766|NCT01263470|Drug|Placebo|Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
16216767|NCT01263457|Device|Easypod|Saizen (Somatotropin) as per Summary of Product Characteristics administered by easypod
16216768|NCT01263444|Drug|Brinzolamide 1% / timolol 0.5% Fixed Combination|
16216769|NCT01263444|Drug|Habitual prostaglandin monotherapy|Topical ocular therapy used daily as prescribed
16216770|NCT01263431|Procedure|Hemorrhoidectomy|Each of the main haemorrhoid is dissected and the apex is ligated and then cut, near to the dentate line
16216771|NCT01263431|Procedure|Hemorrhoidal dearterialization|A special instrument (THD, G.F., Medical Division, Correggio, Italy )with an incorporated Doppler probe is used to detected the six terminal branches of the superior rectal artery which are ligated above the dentate line, then a running suture is performed in order to obtain a mucopexy
16216772|NCT01263418|Drug|Ofatumumab|Intravenous; Dosage: 1000mg; Frequency: one time per week; Duration: 8 weeks
16216773|NCT01263392|Device|Intermittent catheterization|Subjects will use each type of catheter for 6 months and will report weekly in a diary on urinary tract infections (UTIs), urine dip for haematuria & leukocytes, antibiotic use, and days missed school; and will answer a Satisfaction questionnaire at the end of each 6 month arm.
16216774|NCT01263379|Biological|LZRSE-Col7A1 Engineered Autologous Epidermal Sheets|"This trial will create a graft, which we call LEAES, of the patient's own skin that has been genetically engineered in our lab to express this missing protein."
16216775|NCT01263366|Drug|Norepinephrine|Approximately 1.6 or 4.6 mL of a 400 mM norepinephrine solution will be applied topically to a portion of the radiation treatment field prior to each radiation treatment (20-33 treatments)
16216776|NCT01263353|Drug|Pasireotide LAR followed by Pasireotide LAR + Everolimus|
16216777|NCT01263353|Drug|Everolimus followed by Pasireotide LAR + Everolimus|
16216778|NCT01263327|Biological|HPV 16/18|Participants would intramuscularly receive 90mcg of HPV 16/18 bivalent vaccine at 0, 1, 6 month for 3 doses.
16216779|NCT01263314|Drug|MK-8266|Oral capsules, 0.1 mg potency
16216780|NCT01263314|Drug|Placebo|Oral placebo capsules to match MK-8266 capsules
16216781|NCT01263301|Device|carotid duplex|Carotid duplex in the differential diagnosis of subclavian steal syndrome due to Arteriovenous Hemodialysis access in the Ipsilateral arm
16216782|NCT01263288|Dietary Supplement|cholecalciferol|Vitamin D3 tablet 400 IU. Once daily by mouth for 4 months
16216783|NCT01263288|Dietary Supplement|cholecalciferol|Vitamin D3 tablet 1000 IU. Once daily by mouth for 4 months
16216784|NCT01263288|Dietary Supplement|Placebo|Microcrystalline cellulose tablet p.o.daily. (Same color, shape and size as vitamin D tablet)
16216785|NCT01263275|Device|tDCS (Eldith DC-Stimulator (CE certified))|Each tDCS session lasting continuously for 20 minutes at 2 mA
16216786|NCT01263249|Procedure|Catheter Anterior to the Femoral Nerve|Extremity randomized to Anterior Placement will be given a peripheral nerve block with the catheter placed just anterior to the femoral nerve. 4cc of Ropivicaine will be administered continuously every hour by a pain pain pump and the outcome measures will be tested.
16216787|NCT01263249|Procedure|Catheter Posterior to the Femoral Nerve|Extremity randomized to Posterior Placement will be given a peripheral nerve block with the catheter placed just posterior to the femoral nerve. 4cc of Ropivicaine will be administered continuously every hour by a pain pain pump and the outcome measures will be tested.
16216788|NCT01263236|Drug|LY2940094|Administered orally
16216789|NCT01263236|Drug|Placebo|Administered orally
16216790|NCT01263223|Drug|LY2216684|Administered orally
16216791|NCT01263223|Drug|Placebo|Administered orally
16216792|NCT01263210|Biological|Prevenar|
16216793|NCT01263197|Drug|LY2216684|administered orally
16216794|NCT01263197|Drug|albuterol|administered orally
16216795|NCT01263197|Drug|propranolol|administered orally
16216796|NCT01263197|Drug|placebo for LY2216684|administered orally
16216797|NCT01263197|Drug|placebo for albuterol|administered orally
16216798|NCT01263197|Drug|placebo for propranolol|administered orally
16216799|NCT01263171|Drug|Leucovorin|
16216800|NCT01263171|Drug|fluorouracil|
16216801|NCT01263171|Drug|leucovorin calcium|
16216802|NCT01263171|Drug|oxaliplatin|
16216803|NCT01263171|Procedure|adjuvant therapy|
16216804|NCT01263171|Procedure|neoadjuvant therapy|
16216805|NCT01263171|Procedure|therapeutic conventional surgery|
16216806|NCT01263171|Radiation|radiation therapy|
16216807|NCT01263158|Other|Expectancy of standard oxytocin treatment|
16216808|NCT01263145|Drug|Akt Inhibitor MK2206|Given PO
16216812|NCT01263132|Drug|F0434|F0434 will be administered orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose. The subject will continue with this dosage for one week and afterwards, the initial dosage will be increased from 3 capsules per day divided into 3 doses with the same time interval between doses, until visit 3 (week 2).
16216813|NCT01263132|Drug|Gabapentin|Gabapentin will be administered orally with an initial dosage of 3 capsules per day divided into 3 doses with a time interval of 8 hours between each dose. The subject will continue with this dosage for one week and afterwards, the initial dosage will be increased from 3 capsules per day divided into 3 doses with the same time interval between doses, until visit 3 (week 2)
16216814|NCT01263119|Drug|Warfarin|10-mg warfarin oral dose
16216815|NCT01263119|Drug|LY2216684|18-mg LY2216684 oral dose
16216816|NCT01263106|Drug|LY2216684|18-mg LY2216684 oral dose
16216817|NCT01263106|Drug|Theophylline|200-mg theophylline oral dose
16216818|NCT01263093|Drug|Clopidogrel|
16216819|NCT01263093|Drug|LY2216684|
16216820|NCT01263080|Drug|mirtazapine|mirtazapine 30mg QD
16216821|NCT01263080|Drug|folic acid placebo|folic acid placebo 1 tablet QD
16216822|NCT01263080|Drug|mirtazapine placebo|mirtazapine placebo 1 tablet QD
16216823|NCT01263080|Drug|folic acid|folic acid 0.4mg QD
16216824|NCT01263067|Behavioral|Lifespan Integration Therapy|LI treatment guides the client to imaginally visit past memories, and then leads her or him forward through time to the present using a concept referred to as the time line. Beginning with the individual's memories from the traumatic experience, the time line first follows memories from the days and weeks after the trauma, then season by season to the present, and is reviewed in ongoing sessions as increasing details of the traumatic event are uncovered.
16216825|NCT01263067|Behavioral|Lifespan Integration- Control|Participants selected for the control group will be treated 4 weeks following initial contact. Treatment is the same as for the Experimental Group.
16216826|NCT01263054|Device|TransDiscal System|Surgical Procedure using the TransDiscal System to perform disc biacuplasty.
16216827|NCT01263054|Other|Medical Management|Standard medical management, physical therapy, and lifestyle changes.
16216828|NCT01263041|Drug|Glutamine|enteral or via NG tube dose of 312mg/kg/day divided every 12 hours from starting feeding + usual care and medications up to 30 says post natal age
16216829|NCT01263041|Drug|l-arginine|enteral or via NG tube dose of 260mg/kg/day divided every 12 hours from starting feeding + usual care and medications up to 30 says post natal age
16216830|NCT01263028|Drug|Ergocalciferol supplementation|Vitamin D in the form of ergocalciferol will be the drug utilized in the study. This medication is a Vitamin D analog and is normally used in the current study population to help augment those who are deficient in Vitamin D.
16216831|NCT01263015|Drug|Dolutegravir|Dolutegravir (also known as GSK1349572) 50 mg taken once daily
16216832|NCT01263015|Drug|Atripla|Atripla once daily on an empty stomach
16216833|NCT01263015|Drug|Abacavir/Lamivudine|taken once daily; also known as EPZICOM
16216834|NCT01263015|Drug|Abacavir/Lamivudine Placebo|matching placebo taken once daily
16216835|NCT01263015|Drug|Dolutegravir placebo|matching placebo taken once daily
16216836|NCT01263015|Drug|Atripla placebo|matching placebo taken once daily on an empty stomach
16216837|NCT01263002|Drug|clevudine, Adefovir|"Nucleoside-analogue naive patient : Clevudine 30mg qd
~Assess the complete virological response(HBV DNA < 60 IU/ml) at 24 weeks: Only Clevudine 30mg qd
~Assess not the complete virological response at 24 weeks : Add Adefovir 10mg qd
~During medication of Clevudine, virological breakthrough : add adefovir 10mg qd
~During treatment period, composite virological response : stop the medication and F/U for 2 years
~Recurrence after stopping treatment(HBV DNA > 2,000IU/ml) retreat medication at composite virological response.
~complete virological response: HBV DNA < 60 IU/ml
~virological breakthrough : During antiviral treatment, HBV DNA increased from nadir to 1 log10IU/ml continuously."
16216838|NCT01262989|Drug|Test formulation|tamsulosin hydrochloride 0,4 mg (Synthon BV)
16216839|NCT01262989|Drug|Reference formulation|tamsulosin 0,4 mg (Boehringer Ingelheim)
16216840|NCT01262976|Biological|GSK's investigational vaccine 692342|Intramuscular, 2 doses
16216841|NCT01262976|Biological|Physiological saline|Intramuscular, 2 doses
16216842|NCT01262963|Drug|GSK2118436|A single oral dose of 95 mg of GSK2118436 containing approximately 80 µCi of radioactivity
16216843|NCT01262950|Other|portable motion detector|
16216844|NCT01262937|Device|Confocal Imaging|Confocal imaging performed of the digestive system with the use of confocal miniprobes such as the Gastroflex UHD and Cholangioflex miniprobes (Cellvizio, Mauna Kea, Paris, France)
16216845|NCT01262924|Biological|GSK Biologicals' reduced-antigen-content diphtheria-tetanus-acellular pertussis vaccine|Intramuscular, single dose
16216846|NCT01262924|Biological|GSK Biologicals' reduced-antigen-content acellular pertussis vaccine|Intramuscular, single dose
16216847|NCT01262924|Biological|Tedivax-Adult™/ Td-Rix™|Intramuscular, single dose or 2 doses (in the annex phase)
16216848|NCT01262911|Drug|SRT2379|SRT2379 will be supplied as hard gelatin capsules, with each containing 250mg.
16216849|NCT01262911|Drug|Placebo|Matching placebo will be supplied as hard gelatin capsules, with each containing an appropriate amount of placebo.
16216850|NCT01262898|Drug|GSK962040 (5 mg tablet)|5 mg tablet
16216851|NCT01262898|Drug|GSK962040 (25 mg tablet)|25 mg tablet
16216852|NCT01262898|Drug|GSK962040 (125 mg tablet)|125 mg tablet
16216853|NCT01262898|Drug|Placebo|matching placebo tablet
16216854|NCT01262885|Drug|GSK2251052|500 mg tablet, dose levels detailed in Arm description
16216855|NCT01262885|Drug|Placebo|matching placebo tablet
16216856|NCT01262872|Biological|Pneumococcal vaccine GSK 2189242A (LD formulation 1)|Intramuscular injection
16216857|NCT01262872|Biological|Pneumococcal vaccine GSK 2189242A (HD formulation 2)|Intramuscular injection
16216858|NCT01262872|Biological|Synflorix™|Intramuscular injection
16216859|NCT01262872|Biological|Prevnar13™|Intramuscular injection
16216860|NCT01262872|Biological|Tritanrix™-HepB/Hib|Intramuscular injection
16216861|NCT01262872|Biological|Polio Sabin™|Orally
16216862|NCT01262872|Biological|M-Vac™|Intramuscular injection
16216863|NCT01262872|Biological|Stamaril™|Intramuscular injection
16216864|NCT01262859|Drug|bevacizumab|Bevacizumab, 15 mg/kg IV over 30 minutes (if this infusion rate was well tolerated), every 3 weeks until completion of radiation The initial dose will be delivered over 90+/-15 minutes. If the first infusion is tolerated without infusion associated adverse events (fever and/or chills), the second infusion may be delivered over 60+/-10 minutes. If the 60 minute infusion is well tolerated, all subsequent infusions may be delivered over 30+/-10 minutes.
16216865|NCT01262846|Biological|Fluzone®|Fluzone® Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles.
16216866|NCT01262846|Biological|Fluzone®|Fluzone® High dose or Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles.
16216867|NCT01262820|Drug|Pazopanib|Pazopanib, 800 mg by mouth daily each 21 day cycle
16216868|NCT01262807|Other|Exercises|A specific set of standardized exercises will be taught to patients who are randomized to the intervention group. They will be instructed to do these exercises daily while in-cast. They will have an exercise log to track adherence.
16216869|NCT01262794|Biological|CDP6038|100 mg/mL solution for injection, single dose
16216870|NCT01262794|Biological|Placebo|0.9% sodium chloride for injection Single-dose
16216871|NCT01262768|Behavioral|Portion Size Measurement Aids (PSMAs)|Subjects are randomly assigned to receive either 2D or 3D PSMAs to examine accuracy, acceptability and usefulness of the models. Both groups receive brief instructions on the use of the respective PSMAs, complete an accuracy estimation task, and are given the 2D or 3D PSMAs to take home with them to use for 2-4 weeks, after which the researchers telephone parents to complete a brief satisfaction and usefulness survey.
16216872|NCT01262755|Behavioral|Structured Interview|Subjects underwent a structured interview using a laptop computer and answered over 200 standardized questions. All patient had their height, weight, and waist circumference measured.
16216873|NCT01262742|Drug|Carbetocin|80mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
16216874|NCT01262742|Drug|Carbetocin|90mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
16216875|NCT01262742|Drug|Carbetocin|100mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
16216876|NCT01262742|Drug|Carbetocin|110mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
16216877|NCT01262742|Drug|Carbetocin|120mcg carbetocin, IV, over 1 minute following delivery of the fetal head.
16216878|NCT01262729|Procedure|therapeutical hypothermia|Patients after successful cardiopulmonary resuscitation will be treated in accordance to international guidelines (Guidelines 2005 on cardiopulmonary resuscitation. Resuscitation 2005; 67: S7-S23)
16216879|NCT01262729|Drug|Xenon Inhalation|Patients after successful cardiopulmonary resuscitation will be inhalated with 65-70% Xenon within 2 hours additional to therapeutical hypothermia
16216880|NCT01262703|Device|ReZolve Stent|ReZolve Sirolimus-Eluting Bioresorbable Coronary Stent
16216881|NCT01262690|Drug|PF-05230901|Single ascending doses of PF-05230901 in separate cohorts of subjects; each cohort consists of 6 subjects treated with PF-05230901 and 3 subjects treated with placebo.
16216882|NCT01262690|Drug|PF-05230901|Single dose SC
16216883|NCT01262677|Drug|pregabalin|Controlled Release Tablets, 82.5 mg, once per day (QD) for 3 days
16216884|NCT01262677|Drug|pregabalin|Controlled Release Tablets, 165 mg, once per day (QD) for 11 days
16216885|NCT01262677|Drug|pregabalin|Controlled Release Tablets, 330 mg, once per day (QD) for the remainder of the double-blind treatment phase (max is 12 weeks)
16216886|NCT01262677|Drug|pregabalin|Controlled Release Tablets, 165 mg, once per day (QD) for 7 days
16216887|NCT01262677|Drug|pregabalin|Controlled Release Tablets, 82.5 mg, once per day (QD) for 3 days
16216888|NCT01262677|Drug|pregabalin|Controlled Release Tablets, 165 mg, once per day (QD) for the remainder of the up-titration and double-blind treatment and taper phases (max 14.5 weeks)
16216889|NCT01262677|Drug|placebo|matched to the active drug
16216890|NCT01262664|Drug|Prohibitin-TP01|Starting dose of 0.03 mg/kg as an injection under the skin 1 time each day for 28 days.
16216891|NCT01262651|Drug|Nabiximols|
16216892|NCT01262651|Drug|Placebo (GA-0034)|
16216893|NCT01262638|Drug|ETC-1002|ETC-1002 daily for 12 weeks
16216894|NCT01262638|Drug|Placebo|Placebo daily for 12 weeks
16216895|NCT01262625|Device|CCTA|Complete diagnostic CCTA per protocol specifications.
16216896|NCT01262625|Device|SPECT MPI/ICA|Perform SPECT MPI per institutional standard practice; diagnostic ICA will be performed only as indicated per protocol.
16216897|NCT01262612|Drug|immediate cediranib|cediranib 30 mg on day one; Special in this study is the possibility to decrease (to a minimum of 15 mg) or increase the dose (to a maximum of 30 mg oid) during the study to get an individualized optimal palliative treatment with cediranib. The patient will continue cediranib as long as a clinical benefit is experienced, independent of tumour evaluation. Each dose changes should be documented with clear reasoning and documentation of the approach taken
16216898|NCT01262612|Drug|Start cediranib after 28 days Best Supportive Care|patients in this group will start with cediranib after one month best supportive care. Special in this study is the possibility to decrease (to a minimum of 15 mg) or increase the dose (to a maximum of 30 mg oid) during the study to get an individualized optimal palliative treatment with cediranib. The patient will continue cediranib as long as a clinical benefit is experienced, independent of tumour evaluation. Each dose changes should be documented with clear reasoning and documentation of the approach taken.
16216899|NCT01262599|Device|Sham PEMF Device|Inactive device placed in the same manner as the active device; does not deliver pulsed electromagnetic fields
16216900|NCT01262599|Device|Ivivi Torino II PEMF Device|"The PEMF device to be employed in this study is FDA cleared for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue (510(k) number: K903675). The PEMF device will be taped over the affected breast and abdomen. The PEMF signal will consist of a 2 msec burst of 27.12 MHz sinusoidal waves repeating at 2 bursts/sec. The device will automatically provide a 15 minute treatment every 2 hours. Supplied by Ivivi Health Sciences, LLC."
16216901|NCT01262586|Drug|Vildagliptin|
16216902|NCT01262586|Drug|Glimepiride|
16216903|NCT01262573|Procedure|Closure of vaginal cuff|Closure of the vaginal cuff
16216942|NCT01262261|Drug|Probuphine (buprenorphine implant)|Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug.
16216904|NCT01262560|Drug|Manuka honey in liquid form|Patients swallow 10 cc (approximately 2 level teaspoons) of liquid Manuka honey 4 times per day while awake over an approximately 12 hour period (e.g. 8 a.m., Noon, 4 p.m., and 8 p.m.) 7 days/week during concurrent chemotherapy and radiation treatment.
16216905|NCT01262560|Drug|Manuka honey in lozenge form|Patients place 2 lozenges (the equivalent of 10 cc of liquid Manuka honey), one at a time, in the mouth, allowing each lozenge to dissolve on the tongue/in the mouth, swallowing the honey as it dissolves. Patients do this 4 times per day while awake over an approximately 12 hour period (e.g. 8 a.m., Noon, 4 p.m., and 8 p.m.) 7 days/week during concurrent chemotherapy and radiation treatment.
16216906|NCT01262560|Drug|Standard supportive care|"Patients receive standard supporting care for esophagitis-related pain as needed during concurrent chemotherapy and radiation treatment. The following regimen is recommended, but the local standard of care is permitted.
~A compound containing viscous lidocaine and magnesium aluminum oxide (Maalox®);
~Liquid or solid oxycodone, 5-10 mg, every 3 hours as needed."
16216907|NCT01262547|Device|Dermabrasion-Micrografting|Several small pieces of skin, each measuring 1.75 mm in diameter will be harvested from a normal pigmented area using a commercially available suction blister device. This will be attached to a sterile elastomeric substrate and then placed on a recipient area prepared by epidermal dermabrasion (removal of the epidermis).
16216908|NCT01262547|Procedure|Dermabrasion|Only dermabrasion (removal of epidermis) alone will be done at baseline.
16216909|NCT01262534|Other|Clinical profile of patients|Comorbidities and associated type of treatments will be collected.
16216910|NCT01262534|Other|Patient Preferences about treatment|Patient Benefit Index (PBI), for treatment to record patient preferences regarding psoriasis treatment.
16216911|NCT01262534|Other|Quality of Life|The Quality of Life will be assessed by 2 questionnaires (SF-36 questionnaire, to analyze the overall quality of life of patients, and Dermatology Life Quality Index (DLQI), to analyze the quality of life of patients, in dermatological terms).
16216912|NCT01262521|Dietary Supplement|Dietary nitrate|150 ml tab water with 150 umol/kg sodium-nitrate
16216913|NCT01262521|Dietary Supplement|Water|150 ml Chapelle mineral water
16216914|NCT01262495|Other|cryopreservation|cryopreservation of testicular tissue
16216915|NCT01262482|Drug|Oxaliplatin|130 mg/m2, IV during 2 hours on day 1 of each 21 day cycle. Number of cycles: until progression, intolerance or unacceptable toxicity develops, or until patient or investigator decide to stop the treatment.
16216916|NCT01262482|Drug|Sorafenib|400mg, orally, 2 times per day. Until progression, intolerance or unacceptable toxicity develops, or until patient or investigator decide to stop the treatment.
16216917|NCT01262469|Drug|lapatinib + capecitabine|"For Lapatinib: 5 tablets of 250 mg each, once daily, until disease progression or unacceptable toxicity occurence.
~For Capecitabine: 850 mg/m2 twice a day from day 1 to 14 of cycle 1 and 1000 mg/m2 twice a day from day 1 to 14 of the next cycles."
16216918|NCT01262456|Drug|Desmopressin|
16216919|NCT01262456|Drug|Placebo|
16216920|NCT01262443|Procedure|Radiofrequency Ablation|Radiofrequency ablation by a standard 4mm irrigated flexible tip catheter
16216921|NCT01262430|Procedure|OtisMed|OtisMed Custom-fit Shapematching Guides
16216922|NCT01262430|Procedure|Computer Assisted Surgery (CAS)|Stryker Navigation System
16216923|NCT01262417|Procedure|- use of resorbable membrane Seprafilm|use of resorbable membrane during the first surgery for the resection of hepatic metastases, 1 to 4 membranes should be used around the liver
16216924|NCT01262417|Procedure|without resorbable barrier (seprafilm)|non use of resorbable membrane during the first surgery for the resection of hepatic metastases
16216925|NCT01262391|Drug|Solifenacin succinate suspension 2.5 mg|Adolescents and children are given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses are calculated per weight of the participant, targeting to have equivalent doses of 2.5 mg of solifenacin once daily in adults.
16216926|NCT01262391|Drug|Solifenacin succinate suspension 5 mg|Adolescents and children are given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses are calculated per weight of the participant, targeting to have equivalent doses of 5 mg dose of solifenacin once daily in adults.
16216927|NCT01262391|Drug|Solifenacin succinate suspension 10 mg|Adolescents and children are given a single dose of solifenacin succinate liquid suspension orally via syringe in the morning of day 1 followed by a glass of water. Doses are calculated per weight of the participant, targeting to have equivalent doses 10 mg dose of solifenacin once daily in adults.
16216928|NCT01262378|Procedure|abdominal plastic surgery|Surgery for ABDOMINAL SUBCUTANEOUS FAT
16216929|NCT01262365|Drug|Epratuzumab|600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12- week treatment cycles
16216930|NCT01262365|Drug|Epratuzumab|1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles
16216931|NCT01262365|Drug|Placebo|Placebo infusions delivered weekly for 4 weeks over four 12-week treatment cycles
16216932|NCT01262352|Drug|Ivacaftor|150 mg tablet, oral use, twice daily every 12 hours (q12h)
16216933|NCT01262352|Drug|Placebo|Tablet, oral use, twice daily every 12 hours (q12h)
16216934|NCT01262339|Drug|BTX-A|100 units of BTX-A will be delivered subject's hand via iontophoresis and standard of care intradermal injection of 100 units BTX-A will be delivered to the contra-lateral hand
16216935|NCT01262326|Other|Calorie and Carbohydrate Restriction|Carbohydrate Restriction = <20 g/d of dietary carbohydrate intake Calorie Restriction = 1200 kcal/d for women and 1500 kcal/d for men
16216936|NCT01262313|Behavioral|Lifestyle Counseling|"Participants in the intervention group will attend an 8-week group intervention discussing Healthy Creations lifestyle changes."
16216937|NCT01262300|Biological|Varicella Zoster Virus Vaccine (Zostavax)|Single 0.65 mL subcutaneous injection of the live, attenuated VZV zoster vaccine (Zostavax; Merck, Whitehouse Station, NJ).
16216938|NCT01262287|Drug|Dutasteride|dutasteride 4 mg loading dose followed by 1 mg daily for 8-week treatment period
16216939|NCT01262287|Drug|Placebo|placebo capsules in same number as active drug, daily for 8-week treatment period
16216940|NCT01262274|Drug|Anastrozole|ANA is given 1mg daily for 24 weeks.
16216941|NCT01262274|Drug|Anastrozole plus tegafur-uracil|ANA is given 1mg daily for 24 weeks. UFT is given by 270mg/m2 twice a day for 24 weeks.
16216944|NCT01262222|Other|endothelial function testing|After obtaining informed consent, eligible patients will undergo endothelial function testing using the Endo-PAT 2000 (Itamar Medical) device. This PAT device applied to the finger tip will be used to measure change in blood flow in one arm at rest and after a 5 minute occlusion of the brachial artery with a blood pressure cuff. The other arm will serve as the patient's own control. After the cuff is deflated, blood flow normally increases in the arm for a period of time (flow mediated dilatation). In patients with abnormal endothelial function, this increase in blood flow is damped. The ratio of flow in the ischemic finger to the nonischemic finger (RH-PAT) will then be correlated with postoperative cardiac events.
16216945|NCT01262209|Device|portable CCTV|This is a small handheld mini screen intended to improve reading.
16216946|NCT01262209|Device|Telescopes, telemicroscopes and microscopes|These are either worn like glasses, or held in one's hand and are intended to improve distance vision (like details of a hockey game), intermediate vision (like reading a sign), or 'up-close' vision (like reading small print).
16216947|NCT01262209|Device|Absorptive filters|These are worn like glasses, and have tinted colour lenses. They are intended to improve contrast sensitivity, or being able to tell light from dark (like reading gray letters on a white background).
16216948|NCT01262196|Drug|MP4OX|4.3 g/dL pegylated hemoglobin in balanced lactate-electrolyte solution
16216949|NCT01262196|Drug|Saline|Normal saline (0.9%) solution
16216950|NCT01262183|Drug|CRT + Panitumumab|Day -7, day +15 and day +36: panitumumab 9.0 mg/kg i.v. Day +1 to +39: radiation therapy 1.8 Gy fractions 5 times per week to a cumulative dose of 50.4 Gy Day +1 and +29: cisplatin 75 mg/m2 i.v. Day +1 to +4 and +29 to +32: 5-fluorouracil 1000 mg/m2 i.v.
16216951|NCT01262183|Drug|Concurrent chemoradiation therapy without panitumumab|Day +1 to +39: radiation therapy 1.8 Gy fractions 5 times per week to a cumulative dose of 50.4 Gy Day +1 and +29: cisplatin 75 mg/m2 i.v. Day +1 to +4 and +29 to +32: 5-fluorouracil 1000 mg/m2 i.v.
16216952|NCT01262170|Dietary Supplement|CigRx Lozenge|lozenge made of dietary supplements
16216953|NCT01262170|Other|Tobacco Lozenge|lozenge made of compressed cured tobacco extract
16216954|NCT01262157|Device|Extracorporeal Shockwave Therapy Generator (Vascuspec)|Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites.
16216955|NCT01262157|Device|Low intensity shock wave therapy|Gel is spread around the penis and on the Shock Wave applicator and Treatment (12 sessions in total) of 300 shocks per site, on 5 penile anatomical sites.
16216956|NCT01262144|Radiation|Radiotherapy|Radiotherapy for cervical cancer
16216957|NCT01262131|Device|magnetic therapy protocol A|Application of magnetic fields using the Resonator device Protocol A
16216958|NCT01262131|Device|magnetic therapy Protocol B|Application of magnetic fields using the Resonator device Protocol B
16216959|NCT01262131|Device|placebo therapy|Application of inactive magnetic fields using the Resonator device
16216960|NCT01262118|Drug|CP-690,550 (tasocitinib)|CP-690,550 (tasocitinib) dosed at 10 mg BID for 6 weeks in patients with active rheumatoid arthritis
16216961|NCT01262105|Device|Air Barrier System Device|Device is deployed adjacent to the surgery site and activated so that the filtered air emits over the site.
16216962|NCT01262092|Drug|Buprenorphine|Induction onto buprenorphine to a stable dose of 12mg/day. Then induction onto either 0 or 1600mg of gabapentin. Once the maintenance dose of gabapentin is reached a 10-day buprenorphine detoxification will begin.
16216963|NCT01262066|Behavioral|Lifeskills Workshop Intervention|Intervention participants attended 10 one-hour weekly group sessions. The content of the groups followed the LifeSkills Workshop manual and Video ( (Williams LifeSkills, Inc, Durham NC). The LifeSkills Workshop is a structured psycho-educational group intervention using workbooks and videotapes that draw on cognitive-behavioral techniques and stress reduction approaches.
16216964|NCT01262053|Other|Passive Intervention|When a user is about to place orders on a patient, a pop up alert will show the user the name, age, sex, room number and MR# of the patient who is currently activated. The point of the alert is to display identification information about the patient as a double check for the provider to make sure he is on the correct patient. This alert will only occur once at the onset of each order session (i.e. the provider will not be alerted for every single order, but if the provider leaves the order pad and then returns, the alert will reoccur).
16216965|NCT01262053|Other|Active Intervention|"The user will be required to enter the initials, age and sex of the activated patient prior to placing any orders. For example, for a patient named Donald Duck who is 76 years old and male, the user will be required to type dd76m to unlock the order pad. This step will NOT be required for every order, but WILL be required every time the user enters the order pad (i.e. if a user leaves the order pad and then returns, the system will require the initials, age and sex to be re-entered as above). This will be a forcing function."
16216966|NCT01262053|Other|Control|Parallel control with no intervention
16216967|NCT01262040|Other|Narrow Band Imaging (NBI)|The intervention is visual assessment of the peritoneal or pleural surface with NBI followed by biopsy and photographic documentation of any abnormal lesions. Photograph or video of abnormality(ies) under white light and NBI.
16216968|NCT01262027|Drug|Dovitinib|500 mg by mouth for 5 consecutive days, followed by a 2-day rest period (5 days on/2 days off schedule) for every 28 day cycle.
16216969|NCT01262014|Drug|Pazopanib|800 mg (2x400mg) pazopanib per day should be taken orally without food at least one hour before or two hours after a meal until disease progression, the development of unacceptable toxicity, noncompliance, withdrawal of consent by the patient, or investigator decision.
16216970|NCT01262001|Drug|FG-3019|Cohort 1 and Cohort 1-EX: 15 mg/kg by infusion every 3 weeks for 45 weeks in the target population (first treatment year and first extended treatment year and every 3 weeks thereafter for three additional extended treatment years).
16216971|NCT01262001|Drug|FG-3019|Cohort 2 and Cohort 2-EX: 30 mg/kg by infusion every 3 weeks for 45 weeks in the target population (first treatment year and first extended treatment year and every 3 weeks thereafter for three additional extended treatment years).
16216972|NCT01261988|Device|VIPER|Comparison of ostomy systems
16216973|NCT01261988|Device|Esteem™ Cut to Fit One Piece Closed End Pouch|Comparison of ostomy systems
16216974|NCT01261975|Procedure|Coaxial Micro-Incision Cataract Surgery|1.8 mm coaxial micro incision
16216975|NCT01261975|Procedure|Coaxial Small Incision Cataract Surgery|2.75 mm coaxial incision
16218365|NCT01251159|Other|laboratory biomarker analysis|
16216976|NCT01261962|Dietary Supplement|zinc|zinc sulfate, 35 mg twice daily for 4 months
16216977|NCT01261962|Other|Placebo|Placebo, One capsule, twice daily for 4 months
16216978|NCT01261949|Device|Combined frontal and temporal rTMS|Experimental repetitive transcranial magnetic stimulation (Alpine Biomed Mag Pro Option): 1000 stimuli of 1Hz rTMS over the right DLPFC (110% motor threshold) followed by 1000 stimuli of 1 Hz rTMS over the left temporal cortex DLPFC (110% motor threshold)
16216979|NCT01261949|Device|Temporal low frequency rTMS|Experimental repetitive transcranial magnetic stimulation (Alpine Biomed Mag Pro Option): 2000 stimuli of 1 Hz rTMS over the left temporal cortex (110% motor threshold)
16216980|NCT01261923|Drug|Alitretinoin|30 mg capsule of 9-cis-retinoic-acid (9-cis-RA)(Alitretinoin, Toctino®)
16216981|NCT01261910|Behavioral|Intensive initial education|Participants will (1) view a video, brochure, and fact sheet regarding living kidney donation, and (2) discuss the videos and materials with a transplant educator, in-person.
16216982|NCT01261897|Procedure|Adductor-Canal-Blockade with Ropivacaine|US-guided Adductor-Canal-Blockade with ropivacaine 7,5 mg/ml
16216983|NCT01261897|Procedure|Adductor-Canal-blockade with saline|US-guided Adductor-Canal-blockade with saline
16216984|NCT01261884|Behavioral|Exercise support|Group B (exercise support) will be given the ACOG pamphlet on exercise in pregnancy, a daily activity log, and a pedometer. This group will be asked to wear the pedometer for 7 consecutive days between Visits 1 and 2, and record daily activities.
16216985|NCT01261884|Behavioral|Exercise intervention|Group C (exercise intervention) will be given the ACOG pamphlet on exercise in pregnancy, a daily activity log, a pedometer, a resistance band, and a handout on specific exercises (type and frequency) to be performed. The study coordinator will demonstrate each exercise and then observe the participant perform each exercise to assure full understanding. In addition to wearing the pedometer for 7 days and completing the activity log, this group will also record compliance with the exercise regimen.
16216986|NCT01261858|Device|Kryptonite|osteoconductive biologic bone cement to be applied upon sternal closure
16216987|NCT01261832|Drug|antiplatelet therapy|Dual antiplatelet therapy is defined as combination therapy with aspirin and clopidogrel and triple antiplatelet therapy is defined as combination therapy with aspirin,clopidogrel and cilostazol.
16216988|NCT01261819|Device|cystoscopy|
16216989|NCT01261806|Behavioral|Attachment and Biobehavioral Catch-up|Enhances nurturance, following the lead, and calming behaviors
16216990|NCT01261806|Behavioral|Developmental Education for Families|Attention control: Enhances parents understanding of developmental milestones
16216991|NCT01261793|Drug|Placebo|Placebo infusions delivered weekly for 4 weeks over four 12-week treatment cycles
16216992|NCT01261793|Drug|Epratuzumab|600 mg infusions delivered weekly for a total of 4 weeks (cumulative dose 2400 mg) over four 12- week treatment cycles
16216993|NCT01261793|Drug|Epratuzumab|1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over four 12-week treatment cycles
16216994|NCT01261780|Device|MC-5A|45 minutes daily x 10 treatments (given over the course of 2 weeks)
16216995|NCT01261780|Drug|Sham device|Sham therapy daily x 45 minutes for 10 treatments (given over course of 2 weeks)
16216996|NCT01261767|Drug|anti-IL-20|Anti-IL-20 in 100mg/vial for subcutaneous (under the skin) injection
16216997|NCT01261767|Drug|placebo|Placebo for subcutaneous (under the skin) injection
16216998|NCT01261754|Radiation|99mTc MIP 1404|Subjects will be administered a single 20 (± 3) mCi intravenous (IV) injection of 99mTc MIP 1404
16216999|NCT01261754|Radiation|99mTc MIP 1405|Subjects will be administered a single 20 (± 3) mCi intravenous (IV) injection of 99mTc MIP 1405
16217000|NCT01261741|Drug|Memantine|Each subject will receive memantine 10mg tablets once daily
16217001|NCT01261741|Drug|Placebo|Each subject will receive matching placebo tablets once daily
16217002|NCT01261728|Drug|Gemcitabine and Cisplatin|Patients will receive four cycles of GC administered every 21 days. Gemcitabine 1,000 mg/m2 and Cisplatin 35 mg/m2 will be administered intravenously on days 1 and 8. A total of four cycles of therapy will be administered at 21 day intervals followed by radical nephroureterectomy or distal ureterectomy.
16217003|NCT01261715|Procedure|Dermabond- liquid skin adhesive|Dermabond- liquid skin adhesive
16217004|NCT01261702|Drug|Placebo|Normal saline IV
16217005|NCT01261702|Drug|magnesium sulphate|The magnesium group (Group M, n=16) received 50 mg/kg of magnesium sulphate infusion in 10 minutes before induction and then 15 mg/kg/hr until the end of the surgery.
16217006|NCT01261689|Drug|Ropivacaine/ Sufentanil according to local hospital protocol|according to local hospital protocol
16217007|NCT01261689|Other|Care-as usual pain treatment|Pain treatment only on request of the women in labour. Treatment is given according to local hospital protocol.
16217008|NCT01261676|Other|Implementation aids|An implementation strategy to improve outcome for women in labour will be developed depending on the outcome of the current care study and the barrier and facilitator analysis.The strategy will be executed and evaluated in a controlled before-and-after study in 12 hospitals (6 intervention, 6 control)
16217009|NCT01261663|Other|oral nutritional energy and protein enriched supplement (NOS)|
16217010|NCT01261650|Device|transcranial direct current stimulation|
16217011|NCT01261650|Device|sham treatment|
16217012|NCT01261637|Drug|Saline placebo|20ml saline
16217013|NCT01261637|Drug|Ropivicaine|0.25% ropivicaine (maximum 1.5mg/kg)
16217014|NCT01261624|Drug|Givinostat|1.0 mg/kg daily (0.5 mg/kg twice a day) in fed condition 1.5 mg/kg daily (0.75 mg/kg twice a day) in fed condition
16217015|NCT01261611|Biological|Botulinum toxin type A|I.M. (in the muscle) injection on day 1 of up to 5 treatment cycles.
16217016|NCT01261611|Biological|Botulinum toxin type A|I.M. injection on day 1 of treatment cycle 1.
16217017|NCT01261611|Drug|Placebo|I.M. injection on day 1 of treatment cycle 1.
16217018|NCT01261598|Procedure|Positron Emission Tomography|Positron Emission Tomography
16217019|NCT01261572|Drug|degarelix|periodic injection
16217020|NCT01261559|Device|Chrysalis breast displacement device|Chrysalis is a cloth device secured with velcro and buckles around the upper abdomen and chest following manual cephalad breast displacement.
16217049|NCT01261325|Drug|Brivaracetam|Daily oral dose of two equal intakes of Brivaracetam 200 mg/ day in a double-blinded way for the 12-week treatment period.
16217021|NCT01261546|Drug|Dexamethasone|"Dexamethasone 0,25mg/kg, IV, q.i.d. for 2 days.
~Cefotaxime 200 mg/kg, IV, q.d. until discharge criteria are present
~Ranitidine 5 mg/kg IV, q.d. for 2 days
~Amoxicillin/Clavulanic acid orally (80mg/kg/day) during 15 days."
16217022|NCT01261546|Drug|Placebo|"Normal saline 0,6 ml/kg, IV, q.i.d. for 2 days.
~Cefotaxime 200 mg/kg, IV, q.d. until discharge criteria are present.
~Ranitidine 5 mg/kg IV, q.d. for 2 days.
~Amoxicillin- Clavulanic acid 80mg/kg p.o., q.d. during 15 days."
16217023|NCT01261533|Device|foldable capsular vitreous body(FCVB)|FCVB with silicone oil inside is tamponaded into the vitreous cavity
16217024|NCT01261520|Behavioral|Culturally-tailored video|A 18 minute DVD made in Chinese language (i.e. Mandarin and Cantonese)
16217025|NCT01261494|Drug|GFT505 80mg|hard gelatin capsules dosed at 20mg,oral administration,4 capsules per day before breakfast
16217026|NCT01261494|Drug|Placebo|hard gelatin capsules,oral administration,4 capsules per day before breakfast
16217027|NCT01261481|Drug|Tolvaptan|Tolvaptan 15 mg administered once orally as an intact tablet.
16217028|NCT01261481|Drug|Tolvaptan|Tolvaptan 15 mg administered once via nasogastric tube.
16217029|NCT01261468|Device|Active SCS|SCS IPG activated
16217030|NCT01261468|Device|Deactivated|SCS IPG deactivated
16217031|NCT01261455|Procedure|Location of the autograft taken following pterygium excision|Following pterygium excision, a conjunctival autograft is taken from either the superior or inferior conjunctiva.
16217032|NCT01261442|Procedure|Nerve Conduction Study (NCS)|An NCS will be performed on each patient to confirm or exclude DSPN. Following this, a systematic ultrasound examination of the posterior tibial nerve will be performed for all the patients.
16217033|NCT01261429|Drug|Tasigna|"The study drug is nilotinib (Tasigna®). All patients will be administered with nilotinib 400 mg twice a day for one year. The patient will begin the treatment the day of inclusion.
~The prescribed dose should be swallowed whole with a glass of water. Doses of 400 mg should be administered twice daily approximately 12 hours apart. Patients should not eat within two hours before and one hour after taking nilotinib and need to avoid foods such as grapefruit juice which may inhibit CYP3A4 enzymes."
16217034|NCT01261416|Drug|levetiracetam|Patients will receive levetiracetam as needed for clinical and/or electrographic seizures. Need for levetiracetam will be determined by the clinical team and will NOT determined by the study protocol.
16217035|NCT01261403|Biological|PDA001|Dose escalation study: Subjects will be assigned to 1 of 2 treatment groups (1 unit or 4 units vs. vehicle control) based on the order in which they enroll in the study. Intravenous infusion will be administered on days 0 and 7. Nonresponders will be unblinded after 12 weeks of study. Non- responders on vehicle control will be re-dosed with the active PDA001 dose assigned at baseline (2 infusions, 7 days apart). Nonresponders taking active PDA001 will enter the safety follow-up portion of the study. Responders at 12 weeks will continue in the safety and efficacy follow-up portion of the study until 12 months of study. Responders will be treated for RA flare between 3-9 months of study with the active PDA001 dose assigned at baseline (2 infusions, 7 days apart).
16217036|NCT01261403|Drug|Vehicle Controlled Placebo|"Cohort Dose Level 1: 4 units vehicle controlled placebp infused on Day 0 and Day 7
~Cohort Dose Level 2: 4 units vehicle controlled placebo infused on Day 0 and Day 7"
16217037|NCT01261390|Behavioral|Conservative Medical Therapy (CMT)|All participants will meet with a research assistant who will provide 30 minutes of instruction on sleep hygiene and healthy lifestyle guidelines. Each subject's sleep routine will be reviewed with the aim to identify appropriate bed and wake times that provide a consistent schedule and allow for at least 7 hours of time in bed per night. Habits that may impact sleep, such as alcohol consumption, tobacco use, and exercise close to bedtime will be reviewed with appropriate guidance on how to minimize sleep disrupting exposures. Subjects will be provided external nasal dilator strips (Breathe Right®) and advised on how to maximize sleep time in a non-supine position using bed elevation, wedge pillows and/or objects affixed to the back of their night clothes as appropriate.
16217038|NCT01261390|Device|Sham PAP (Sham)|In addition to receiving CMT, participants in this treatment arm will receive a sham PAP unit. Sham devices look like active PAP devices, however, the exhalation port is increased and an orifice-resistor is inserted between the pump and tubing, creating a marginal pressure. A heated humidifier will be provided with this device and PAP masks will be fit and provided following the same procedures as for the active-PAP arms.
16217039|NCT01261390|Device|Active PAP with RT Support (Active-Beh)|In addition to receiving CMT, participants will receive active-PAP and meet with a PAP-specialist . The CPAP specialist would meet with the participant in person throughout the course of the study (set-up, 1-week, 1-month, 3-month, 6-month, and 9-month). Using the available data from the PAP monitor, the PAP specialist will discuss PAP use, mask leaks, and residual AHI to assist with troubleshooting. Adjustments to equipment would be performed as needed to improve adherence. It is estimated that each in-person follow-up adherence visit with the PAP-specialist would last 30 minutes.
16217040|NCT01261390|Device|Active PAP with Behavioral Modification (Active+Beh)|In addition to receiving CMT and active-PAP, participants will meet with a behavioral interventionist in addition to PAP-specialist visits. Participants also would speak with the behavioral interventionist over the course of the study (set up, 1-week, 3-week, 1-month, 2-months, 3-months, 5-months and 8-months). The duration of the first 2 behavioral intervention sessions are estimated to be 1-hour long, with subsequent 30-minutes intervention sessions. The intervention will be based on social cognitive theory and feedback concerning adherence with targeted problem solving training.
16217041|NCT01261377|Device|Bi-level positive airway pressure (BPAP)|The level of BPAP will be titrated to treat OSA as well as hypoxemia and hypercapnia. The duration of therapy will be six months.
16217042|NCT01261377|Drug|Oxygen|Oxygen will be titrated to keep resting oxygen saturation (as measured by pulse oximeter) more than 88 percent. The duration of therapy will be six months.
16217043|NCT01261377|Device|CPAP|The level of CPAP will be titrated to treat OSA. The duration of therapy will be six months.
16217044|NCT01261364|Behavioral|GeneSightRx|Multi-genetic pharmacogenomic panel
16217045|NCT01261364|Behavioral|Treatment as usual|Treatment as usual
16217046|NCT01261338|Drug|olestra|non-absorbable dietary fat
16217047|NCT01261325|Drug|Placebo|Daily oral dose of two equal intakes of placebo in a double-blinded way for the 12-week treatment period
16217048|NCT01261325|Drug|Brivaracetam|Daily oral dose of two equal intakes of Brivaracetam 100 mg/ day in a double-blinded way for the 12-week treatment period
16217050|NCT01261325|Drug|Antiepileptic drugs with market authorization available per country|
16217051|NCT01261312|Drug|SGI-110|"SGI-110 subcutaneous injection administered on Days 1-5
~SGI-110 subcutaneous injection administered on Days 1-5 and 8-12"
16217052|NCT01261312|Drug|SGI-110|"SGI-110 administered weekly on Days 1, 8 and 15
~SGI-110 administered weekly on Days 1, 4, 8, 11, 15, and 18"
16217053|NCT01261299|Drug|Carbon-14-labeled carboplatin|Patients are eligible for this study if they have non-small cell lung cancer or bladder cancer and will receive cisplatin or carboplatin-based chemotherapy for the treatment of cancer. They will receive one microdose of C-14-carboplatin approximately 4 hours before scheduled biopsy/surgery. One blood draw and a few milligrams of leftover tumor tissue will be taken for analysis of carboplatin-DNA adduct levels. The dose of carboplatin will be about 1/100th the therapeutic dose.
16217054|NCT01261286|Drug|verapamil|
16217055|NCT01261260|Drug|Uridine|1 gram tablets BID for 7 days
16217063|NCT01261234|Drug|Cilostazol or Non-Cilostazol|Cilostazol group administrate 100-200mg/day per oral, unrestricted use of other antiplatelet agents and concomitant drugs.
16217064|NCT01261182|Other|In School Feeding|The intervention provides meals consisting of 1049 kcals of energy, 32.6 gm protein, and 24.9 gm fat per child per school day and meet at least two thirds of the child's daily vitamin and mineral requirements, including 99 percent of iron requirements. SFP delivers these nutrients in the form of a fortified corn-soy porridge around mid-morning and beans and maize meal or rice at lunch.
16217065|NCT01261182|Other|Take Home Rations|The rations provided in the intervention are equal in size and composition to the food received in the in-school feeding intervention, but are provided to households once per month.
16217066|NCT01261169|Drug|Myfortic|Myfortic in uveitis
16217067|NCT01261156|Drug|E5555 100 mg and diltiazem|E5555 single 100 mg oral dose in Treatment Period 1 Day 1 and in Treatment Period 2 Day 8. Diltiazem 360 mg orally each day for 14 days (Days 1-14) in Treatment Period 2.
16217068|NCT01261156|Drug|E5555 300 mg and diltiazem|E5555 single 300 mg oral dose in Treatment Period 1 and in Treatment Period 2 Day 8. Diltiazem 360 mg orally each day for 14 days (Days 1-14) in Treatment Period 2.
16217069|NCT01261143|Drug|BK-C-0701|tablet, 8 weeks
16217070|NCT01261130|Biological|10 μg Na-GST-1/Alhydrogel|3 doses 10 μg Na-GST-1/Alhydrogel administered at 56 day intervals
16217071|NCT01261130|Biological|30 μg Na-GST-1/Alhydrogel|3 doses 30 μg Na-GST-1/Alhydrogel administered at 56 day intervals
16217072|NCT01261130|Biological|100 μg Na-GST-1/Alhydrogel|3 doses 100 μg Na-GST-1/Alhydrogel administered at 56 day intervals
16217073|NCT01261130|Biological|10 μg Na-GST-1/ Alhydrogel/GLA-AF|3 doses 10 μg Na-GST-1/ Alhydrogel/GLA-AF administered at 56 day intervals
16217074|NCT01261130|Biological|30 μg Na-GST-1/Alhydrogel/GLA-AF|3 doses 30 μg Na-GST-1/Alhydrogel/GLA-AF administered at 56 day intervals
16217075|NCT01261130|Biological|100 μg Na-GST-1/Alhydrogel/GLA-AF|3 doses 100 μg Na-GST-1/Alhydrogel/GLA-AF administered at 56 day intervals
16217076|NCT01261130|Biological|Butang® hepatitis B vaccine|3 doses Butang® hepatitis B vaccine administered at 56 day intervals
16217077|NCT01261117|Drug|oral ibuprofen|oral or iv ibuprofen in 10, 5 and 5 mg/kg/day with 24 hr intervals
16217078|NCT01261091|Procedure|Early Tracheostomy|Tracheostomy is performed as percutaneous dilatative tracheostomy by neurointensivists whenever possible. If anatomically or otherwise indicated, surgical tracheostomy is applied.
16217079|NCT01261091|Procedure|Late Tracheostomy|Tracheostomy is performed as percutaneous dilatative tracheostomy by neurointensivists whenever possible. If anatomically or otherwise indicated, surgical tracheostomy is applied.
16217080|NCT01261078|Drug|Placebo|intrathecal 8 mg of bupivacaine only
16217081|NCT01261078|Drug|epinephrine 25|intrathecal 8 mg of bupivacaine mixed with 25 mcg of epinephrine
16217082|NCT01261078|Drug|Epinephrine 50|intrathecal 8 mg of bupivacaine mixed with 50 mcg of epinephrine
16217083|NCT01261078|Drug|epinephrine 100|intrathecal 8 mg of bupivacaine mixed with 0.1 mg of epinephrine
16217084|NCT01261078|Drug|Epi 200|intrathecal bupivacaine 8 mg with 200 mcg of epinephrine
16217085|NCT01261065|Drug|carvedilol|Patients with heart failure and LVEF < 35 % were treated with maximally tolerated dose of carvedilol for a period of six months. Target dose was 25 mg bid or 37.5 mg bid if patient's baseline weight > 80 kg.
16217086|NCT01261052|Device|The Fading Memory Proportional Derivative/Adaptive Proportional Derivative Algorithm|"The APD algorithm is based largely on a program that employs the Fading Memory Proportional Derivative (FMPD) insulin and glucagon infusion algorithm. The FMPD algorithm determines insulin and glucagon delivery rates based on proportional error, defined as the difference between the current glucose level and the target level, and the derivative error, defined as the rate of change of the glucose. The fading memory designation refers to weighting recent errors more heavily than remote errors.
~The APD algorithm, like the FMPD algorithm, will determine insulin and glucagon infusion rates based on sensed glucose values and utilizes the derivative and proportional glucose error to determine delivery rates of insulin. However, the APD algorithm has a model predictive element which also leads to frequent measurement of tissue sensitivity to insulin."
16217087|NCT01261052|Device|The Adaptive Proportional Derivative Algorithm|"The APD algorithm is based largely on a program that employs the Fading Memory Proportional Derivative (FMPD) insulin and glucagon infusion algorithm. The FMPD algorithm determines insulin and glucagon delivery rates based on proportional error, defined as the difference between the current glucose level and the target level, and the derivative error, defined as the rate of change of the glucose. The fading memory designation refers to weighting recent errors more heavily than remote errors.
~The APD algorithm, like the FMPD algorithm, will determine insulin and glucagon infusion rates based on sensed glucose values and utilizes the derivative and proportional glucose error to determine delivery rates of insulin. However, the APD algorithm has a model predictive element which also leads to frequent measurement of tissue sensitivity to insulin."
16217088|NCT01261039|Radiation|UV radiation|Subjects in both groups will be exposed to light in a solar bed for approximately 10 minutes (depending on Fitzpatrick skin type test) on the first day, but only one of the solar beds wields ultraviolet rays. The other has a filter, which filters out the ultraviolet rays.
16217089|NCT01261000|Drug|Pegvisomant|Pegvisomant used as indicated
16217090|NCT01260987|Drug|Conventional photodynamic therapy|Photodynamic therapy using methyl-aminolevulinate and red light (37 J/cm2)
16217091|NCT01260987|Drug|Fractional CO2 laser assisted PDT|Pretreatment with fractional CO2 laser before methyl-aminolevulinate PDT
16217092|NCT01260974|Drug|Caspofungin|50mg/dd for 21dd, starting within 24h from Liver Transplantation.
16217093|NCT01260961|Dietary Supplement|Placebo|The volunteers will start on the 200 mg daily of the placebo and will not increase their dose during the study.
16217094|NCT01260961|Dietary Supplement|Docosahexanoic Acid|The volunteers will start on the 200 mg daily of the DHA capsule and will not increase their dose during the study.
16217095|NCT01260948|Drug|Donepezil Hydrochloride|10 mg Orally Disintegrating Tablet
16217096|NCT01260948|Drug|Aricept®|10 mg Orally Disintegrating Tablet
16217097|NCT01260935|Procedure|Laparoscopic Hill Repair|With the Hill repair, stitches are placed right where the esophagus and stomach meet and attached to muscle tissue that is fixed to the spine.
16217098|NCT01260935|Procedure|Laparoscopic Nissen Repair|With the Nissen repair, the upper part of the stomach is wrapped around the esophagus, with some anchoring of the wrap at several locations.
16217099|NCT01260922|Drug|Donepezil Hydrochloride|10 mg Orally Disintegrating Tablet
16217100|NCT01260922|Drug|Aricept®|10 mg Orally Disintegrating Tablet
16217101|NCT01260909|Device|Real-time kV/MV Prostate Imaging|The kV images will be acquired using onboard kV X-Ray imaging system existing in the clinical linear accelerator (LINAC).
16217102|NCT01260896|Drug|Venlafaxine Hydrochloride|150 mg Extended-Release Capsule
16217103|NCT01260896|Drug|Effexor® XR|150 mg Extended-Release Capsule
16217104|NCT01260883|Drug|Ketorolac Tromethamine 1 mg/kg|Ketorolac Tromethamine 1 mg/kg infusion over 10 minutes intravenous (IV) infusion. Blood sampling in for up to 12 hours after infusion for analysis of ketorolac concentrations and safety assessments.
16217105|NCT01260883|Drug|Ketorolac Tromethamine 0.5 mg/kg|Ketorolac Tromethamine 0.5 mg/kg infusion over 10 minutes intravenous (IV) infusion. Blood sampling for up to 12 hours after infusion for analysis of ketorolac concentrations and safety assessments.
16217106|NCT01260883|Drug|Placebo|Dextrose in water (D5W) infusion over 10 minutes intravenous (IV) infusion. Blood sampling for up to 12 hours after infusion for analysis of ketorolac concentrations and safety assessments.
16217107|NCT01260870|Device|Cotavance Paclitaxel Coated Balloon|DEB
16217108|NCT01260870|Device|Standard balloon angioplasty|POBA
16217109|NCT01260857|Drug|Aldazide|Aldazide 25 mg OD
16217110|NCT01260844|Drug|briakinumab|single dose briakinumab and 2 doses of CYP substrates
16217111|NCT01260831|Other|Implementation of Bedside Paediatric Early Warning System|The Bedside Paediatric Early Warning System (Bedside PEWS) is a documentation-based system of care that will replace existing documentation systems for vital signs in inpatient ward areas in hospitals randomized to implement Bedside-PEWS. Frontline staff education within each hospital will occur over a period of three months preceding a 5 week run-in implementation phase, which will be followed by hospital-wide implementation. The Bedside-PEWS documentation record will become the primary method of documentation for vital signs and related data.
16217112|NCT01260831|Other|Hospital Standard of Care|Hospitals randomized to standard care will continue with established methods of care. This will include the use of calling criteria and/or the expert model to identify children at risk. As in intervention hospitals, existing MET-RRT practices, established staffing and documentation practices will continue.
16217113|NCT01260818|Drug|Tranexamic Acid|1 g Tranexamic Acid mixed with 100ml saline are kept in wound for 2 hours before drainage is opened postoperatively
16217114|NCT01260818|Drug|normal saline|100ml saline is kept in wound for 2 hours before drainage is opened postoperatively
16217115|NCT01260805|Drug|Reference Drug|Femiane® Ethinylestradiol 0,02mg + Gestodene 0,075mg sugar coated tablets single dose
16217116|NCT01260805|Drug|Test Drug|Harmonet® Ethinylestradiol 0,02mg + Gestodene 0,075mg sugar coated tablets single dose
16217117|NCT01260792|Other|questionnaire|The teachers or the professors complete questionnaires on the child on their behavior in classes
16217118|NCT01260792|Other|Questionnaire|The parents complete a questionnaire on the behavior of their child and on their own behavior
16217119|NCT01260779|Drug|PV-10 (10% rose bengal disodium)|Intralesional injection for chemoablation of cutaneous or subcutaneous lesions
16217120|NCT01260766|Device|Oplon Active Patch|Patches are placed over acne lesion overnight. Treatment is a single treatment.
16217121|NCT01260766|Device|Placebo Patch|same as active patch
16217122|NCT01260753|Drug|UR-63325|UR-63325
16217123|NCT01260753|Drug|Fluticasone propionate nasal spray|Fluticasone propionate nasal spray
16217124|NCT01260753|Drug|Placebo|Placebo to UR 63325 and fluticasone propionate nasal spray
16217125|NCT01260727|Biological|PENNVAX-G DNA Vaccine|PENNVAX-G DNA (HIV-1 env A, C, and D, and consensus gag plasmids) vaccine; 4 mg administered IM as a total volume of 1 mL
16217126|NCT01260727|Biological|MVA-CMDR Vaccine|MVA-CMDR live attenuated modified vaccinia ankara vector (HIV-1 CM235 env/CM240 gag/pol); 1 x 10^8 plaque-forming unit (pfu) administered IM by needle and syringe as a volume of 1 mL in either deltoid
16217127|NCT01260727|Biological|Placebo PENNVAX-G Vaccine|Sodium Chloride Injection USP, 0.9%
16217128|NCT01260727|Biological|Placebo MVA-CMDR Vaccine|Sodium Chloride Injection USP, 0.9%
16217129|NCT01260714|Drug|Azacitidine|Given SC
16217130|NCT01260714|Drug|Etoposide|Given IV
16217131|NCT01260714|Other|Laboratory Biomarker Analysis|Correlative studies
16217132|NCT01260714|Drug|Mitoxantrone Hydrochloride|Given IV
16217133|NCT01260701|Drug|Akt Inhibitor MK2206|Given PO
16217134|NCT01260688|Drug|cediranib maleate|Given orally
16217135|NCT01260688|Drug|dasatinib|Given orally
16217136|NCT01260675|Drug|Buprenorphine HCl/Naloxone HCl|
16217137|NCT01260662|Drug|Propofol|1 mg/kg IV bolus followed by 0.5 mg/kg every 3 minutes as need for sedation
16218456|NCT01250470|Drug|Montanide ISA-51/Survivin Peptide Vaccine|Given SC
16217138|NCT01260662|Drug|1:1 Propofol/Ketamine|Propofol and ketamine mixed 1:1, given at 1 mg/kg IV bolus followed by 0.5 mg/kg every 3 minutes as need for sedation
16217139|NCT01260662|Drug|4:1 Propofol/Ketamine|Propofol and ketamine mixed 4:1, given at 1 mg/kg IV bolus followed by 0.5 mg/kg every 3 minutes as need for sedation
16217140|NCT01260649|Drug|ketamine|eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg) or IV Saline, followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care
16217141|NCT01260649|Other|IV Saline|eligible patients will be randomly assigned to a double-blind administration of ketamine (0.5 mg/kg) or IV Saline, followed by the routine anesthetic agent and muscle relaxant. ECT will be administered as per standard of care
16217142|NCT01260649|Procedure|ECT|ECT will be administered as per standard of care
16217143|NCT01260649|Drug|Muscle Relaxant|All participant will receive routine course of muscle relaxant with ECT as per standard of care
16217144|NCT01260649|Drug|Anesthetic Agents|All participant will receive routine course of anesthetic agents with ECT as per standard of care
16217145|NCT01260636|Drug|Gadobenate Dimeglumine|0.1 mmol/kg, single dose
16217146|NCT01260636|Drug|Gadopentetate Dimeglumine|Double dose of 0.2 mmol/kg
16217147|NCT01260623|Drug|Prednisolone and prednisone|oral, or intravenous prednisone, prednisolone, given the first time for asthma exacerbation
16217148|NCT01260610|Drug|Tenofovir|300 mg of Tenofovir daily
16217149|NCT01260610|Drug|Telbivudine|600 mg of Telbivudine daily
16217150|NCT01260610|Drug|Tenofovir plus Telbivudine|Tenofovir (300 mg daily) plus Telbivudine (600 mg daily)
16217151|NCT01260597|Behavioral|IVR intervention|If individuals report having any smoking in the previous 30 days, the IVR will deliver questions to identify barriers to quit line re-enrollment and motivational messages to promote the re-enrollment
16217152|NCT01260597|Behavioral|IVR control|If individuals report any smoking in the last 30 days the IVR will thank them for their time and the call will end
16217153|NCT01260584|Drug|Prasugrel|One 10 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken.
16217154|NCT01260584|Drug|Clopidogrel|One 75 mg film-coated, oral tablet daily x 10 days. In addition, aspirin 81 mg to 325 mg daily will be taken.
16217155|NCT01260571|Drug|Benzoyl peroxide and sulfur|topical cream, 5% benzoyl peroxide and 2% sulfur Frequency once to day Duration 24 hours
16217156|NCT01260558|Device|Sirolimus-Permanent-Polymer Eluting Stent|due randomization sirolimus-permanent-polymer eluting stent was implanted
16217157|NCT01260558|Device|Sirolimus-Polymer-free Eluting Stent|due randomization sirolimus-polymer-free eluting stent was implanted
16217158|NCT01260545|Drug|CA-18C3|2.5 mg/kg, 3.75 mg/kg IV (in the vein) on Day 1 of each 14 day cycle until the subject is no longer benefiting clinically or unacceptable toxicity occurs.
16217159|NCT01260519|Drug|Heparin|unfractionated heparin 2000 unites
16217160|NCT01260506|Drug|VB-111|
16217161|NCT01260506|Drug|Bevacizumab|Upon progression, subjects will receive a combination therapy of VB-111 and standard of care bevacizumab
16217162|NCT01260493|Other|integrated health care chain|Geriatric assessment at ED, case manager with multiprofessional team in the community, support for informal caregivers
16217163|NCT01260480|Other|[18F]-ML-10 in conjunction with PET imaging|Subjects will receive two to three intravenous (IV) doses of [18F]-ML-10. The dose for each [18F]-ML-10 dose will be 5.50 MBq/Kg or 0.15 mCi/Kg but will not exceed 500.00 MBq (13.50 mCi) per administration.
16217164|NCT01260467|Drug|memantine|10 milligrams orally twice a day
16217165|NCT01260454|Drug|Qutenza (8% capsaicin)|We will place a Qutenza (8% capsaicin) patch onto an area of normal, anesthetized skin for 60 minutes. Within 28 days, subjects will place a new treprostinil infusion site into the area of Qutenza pre-treated skin.
16217166|NCT01260441|Other|CPR Training using the Family and Friends CPR Anytime VSI Kit|Subjects will be trained using the American Heart Association's Family and Friends CPR Anytime Kit. Subjects will undergo training in-hospital and will be encouraged to take the kit home to share with their family members and friends.
16217167|NCT01260428|Device|threshold PEEP|Various set of pressures : 0, 5, 10 cm H20; pursed lips breathing
16217168|NCT01260415|Drug|Panitumumab, Oxaliplatin, 5-FU|"Panitumumab 6 mg / kg, given over 60 minutes
~Oxaliplatin 85 mg / m2 combined with leucovorin 400 mg / m2, given over 2 hours OR
~Irinotecan 180 mg / m2 , given over 90 minutes, concurrent with leucovorin 400 mg / m2, given over 90 minutes
~5FU 400 mg / m2, by bolus infusion
~5FU 2400 mg / m2, given over 46 hours"
16217169|NCT01260402|Device|Resynchronization using a transeptal approach|"Cardiac resynchronization with one in the right ventricle and one in the left ventricle via a transeptal puncture.
~Devices used for procedure : Medtronic C304 or 6227DEF, Nykanen RF Wire, RADI PressureWire"
16217170|NCT01260402|Device|Resynchronization using a coronary sinus approach|"Cardiac resynchronization with one in the right ventricle and one in the left ventricle via the coronary sinus.
~Devices used for procedure : RADI PressureWire, routine catheters chosen by operator"
16217171|NCT01260389|Behavioral|pharmaceutical care intervention|Pharmaceutical care intervention, focused at improving inhalation technique and drug adherence in patients with Chronic Obstructive Pulmonary Disease (COPD).
16217172|NCT01260376|Drug|Acipimox|Tablet Acipimox 250 mg administered 4 times previous to and during the investigation day
16217173|NCT01260363|Procedure|Femoral nerve block|Femoral nerve block ultrasound guidet with ropivacaine 20ml 2.5mg/ml
16217174|NCT01260363|Procedure|Local infiltration analgesia|Local infiltration analgesia with ropivacaine 2.5mg/ml with epfinedrine 5mikrogram/ml. 20ml at harvest site and 20ml at incisionsites.
16217175|NCT01260350|Drug|SOF|Sofosbuvir (SOF) tablets administered orally once daily
16217176|NCT01260350|Drug|RBV|Ribavirin (RBV) capsules administered orally in a divided daily dose
16217177|NCT01260350|Drug|PEG|Peginterferon alfa-2a (PEG) administered via subcutaneous injection once weekly
16217178|NCT01260350|Drug|LDV|Ledipasvir (LDV) tablets administered orally once daily
16217179|NCT01260350|Drug|GS-9669|GS-9669 tablets administered orally once daily
16217180|NCT01260350|Drug|LDV/SOF|LDV/SOF fixed-dose combination (FDC) tablet administered once daily
16217244|NCT01259804|Dietary Supplement|Peanut oral immunotherapy|Daily doses of peanut flour
16217478|NCT01258075|Drug|High-dose colesevelam|3.75 grams colesevelam hydrochloride in oral suspension
16217181|NCT01260337|Behavioral|Portion controlled diet|Participants learn skills for changing nutritional and lifestyle habits and diabetes management follow a program that includes eating a pre-packaged, portion controlled meal for weight loss in addition to attending the behavior modification groups
16217182|NCT01260337|Other|Diabetes Support and Education|The DSE groups will consist of educational sessions offered for diabetes support and education which will include sessions on diet/nutrition, exercise, foot care and living with diabetes.
16217183|NCT01260324|Other|No intervention given in this observational study|No intervention given in this observational study
16217184|NCT01260324|Other|No intervention given in this observational study|No intervention given in this observational study
16217185|NCT01260311|Drug|Fesoterodine|Any dose of Fesoterodine
16217186|NCT01260298|Device|MC1 Ultrasonic Device|Ultrasonic and zonal massage device.
16217187|NCT01260285|Drug|Vardenafil|10 mg PO once
16217188|NCT01260272|Other|Alternative Snack Comparator|Any prepackaged commercial snack is permitted as an alternative comparator snack, as long as it is 100 kcal/serving, does not contain raisins, does not contain solely fruits, and/or does not contain solely vegetables. Preferred comparator snack examples include: Keebler® Cheez-It® Crackers, Fudge Shoppe ® Grasshopper® Cookies, Fudge Shoppe ® Mini Fudge Stripes ™ Cookies, Nabisco Chips Ahoy! Baked Chocolate Chip Snacks, Honey Maid Cinnamon Roll Thin Crisps, Lorna Doone Baked Shortbread Cookie Crisps, Oreo Baked Chocolate Wafer Snacks, Pepperidge Farm® Goldfish® Baked Snack Crackers
16217189|NCT01260272|Other|Raisins|Raisins are dry grape fruits that may be eaten raw, or used in cooking, baking, and brewing. Raisins are mostly composed of carbohydrates (mostly fructose). They are also high in fiber and antioxidants, relatively high in potassium, and low in sodium.
16217190|NCT01260259|Procedure|RIPC|RIPC will be elicited in the operating room (OR) after anesthesia induction and before start of surgery. After placement of an arterial line, a tourniquet will be placed over a lower extremity. It will be inflated to 15 mmHg above systolic blood pressure for 5 minutes, and then deflated for 5 minutes. This cycle of inflation-deflation will be repeated another 3 times before surgery.
16217191|NCT01260259|Procedure|Control|In OR, after induction of general anesthesia and arterial line placement, a deflated tourniquet will be placed over the lower extremity for 40 minutes.
16217192|NCT01260246|Drug|sitagliptin|pill, 100mg/daily for 6 months
16217193|NCT01260246|Drug|placebo|placebo match for 6 months
16217194|NCT01260233|Other|Smoking cessation program|"Smoking cessation program includes:
~brief smoking cessation counselling by preadmission nurse (less than 5 minutes)
~smoking cessation brochures
~referral to the Smokers' Helpline telephone advice line, run by the Canadian Cancer Society
~free transdermal nicotine replacement therapy for 6 weeks Smokers of 10 cigarettes per day or more receive 4 weeks of nicoderm 21mg/day, 1 week of 14mg/day and 1 week of 7mg/day Smokers of less than 10 cigarettes per day receive 4 weeks of nicoderm 14mg/day and 2 weeks of 7mg/day"
16217195|NCT01260220|Procedure|Circumferential Antral Ablation|The goal is to complete ablation in all segments around the pulmonary veins until a circle of ablation lesions is created in the antrum with at least 30 seconds of ablation, 25W on the posterior surface, 30W on the anterior surface at each site, and change in the local electrogram. Entry and Exit block will be confirmed in each vein. The left superior pulmonary vein and left inferior pulmonary vein will be isolated with one circle, and the right superior and right inferior pulmonary veins will be isolated with one circle.
16217196|NCT01260220|Procedure|Segmental Antral ablation|If the patient is in atrial fibrillation, ablation will begin in the segment with the highest frequency signals in the pulmonary vein antrum. If the patient is in sinus rhythm, mapping and ablation will occur during coronary sinus pacing. Segments with the earliest signals in the Lasso catheter will be targeted, and reassessed after each ablation lesion. This will continue in a segmental fashion on the antrum until pulmonary vein isolation is achieved. Lasso should be moved between veins between lesions to assess the earliest electrogram. Entry and exit block will be confirmed at each vein.
16217197|NCT01260207|Other|IVR group|Patients in this arm will receive IVR follow-up telephone calls at 1,3,6,9 and 12 months post-discharge consisting of predetermined questions related to medication management, smoking cessation, diet, exercise and education as recommended by the ACC/AHA BPG for ACS. Upon completion of the IVR follow-up, all patients will be called by a member of the clinical research staff and asked to complete a follow-up survey.
16217198|NCT01260194|Drug|trastuzumab [Herceptin]|Loading dose of 8 mg/kg on day 1, followed by 6 mg/kg intravenous infusion every 3 weeks until disease progression in combination with standard chemotherapy
16217199|NCT01260181|Drug|Erlotinib|Erlotinib 150 mg tablet will be given orally daily.
16217200|NCT01260155|Drug|E5501|Treatment A: 40 mg new tablet formulation (1 tablet) under fasted conditions
16217201|NCT01260155|Drug|E5501|Treatment B: 20 mg old tablet formulation (2 tablets) under fasted conditions
16217202|NCT01260155|Drug|E5501|Treatment C: 40 mg new tablet formulation administered with food
16217203|NCT01260142|Drug|Fospropofol disodium, propofol|Two Treatment Periods: fospropofol disodium 6.5 mg/kg single intravenous (IV) bolus followed by propofol injectable emulsion 0.65 mg/kg IV bolus, or propofol injectable emulsion 0.65 mg/kg IV bolus followed by fospropofol disodium 6.5 mg/kg IV bolus.
16217204|NCT01260142|Drug|Fospropofol disodium, propofol|Two Treatment Periods: fospropofol disodium 10.0 mg/kg single intravenous (IV) bolus followed by propofol injectable emulsion 1.0 mg/kg IV bolus, or propofol injectable emulsion 1.0 mg/kg IV bolus followed by fospropofol disodium 10.0 mg/kg IV bolus.
16217205|NCT01260142|Drug|Fospropofol disodium, propofol|Two Treatment Periods: fospropofol disodium 15.0 mg/kg single intravenous (IV) bolus followed by propofol injectable emulsion 1.5 mg/kg IV bolus, or propofol injectable emulsion 1.5 mg/kg IV bolus followed by fospropofol disodium 15.0 mg/kg IV bolus.
16217206|NCT01260129|Drug|Silodosin|Silodosin 8 mg orally, once daily after morning meal
16217207|NCT01260129|Drug|Silodosin|Silodosin 4 mg orally, twice daily after morning and evening meal
16217208|NCT01260103|Drug|Temozolomide|Study subjects in a fasting state receive TMZ orally once a day for five consecutive days (days 1 through 5) at a starting dose of 200 mg/m2/day. Treatment cycles are repeated every 28 days following the first daily dose of TMZ from the previous cycle. In the absence of PD or unacceptable toxicity, subjects continue to receive TMZ for a maximum of 13 cycles.
16217209|NCT01260103|Drug|ANP Therapy|Escalating doses of ANP therapy are administered for 52 weeks. If the study subject has an OR or maintains SD, ANP therapy is continued.
16217210|NCT01260090|Device|Vagus nerve stimulation;|"Name of the Device:
~We will use the PMA approved version of the NCP System, including the NCP Generator (model 103), NCP Programming Wand (model 201), NCP Programming Software (model 250v7.1), NCP Lead (model 304), NCP Tunneling Tool (model 402) and the Patient Magnet (model 220).
~FDA Facility Registration Number: 1644487"
16217211|NCT01260090|Device|No stimulation|Vagus nerve stimulation
16217212|NCT01260064|Procedure|Open appendectomy|The subjects will have traditional open appendectomy procedure.
16217213|NCT01260064|Procedure|Laparoscopic appendectomy with metal endoclips|The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by metal endoclips.
16217214|NCT01260064|Procedure|Laparoscopic appendectomy with suture ligation|The subjects will have laparoscopic appendectomy in which the appendiceal stump is secured by intracorporeal suture ligation.
16217215|NCT01260025|Drug|PEDylated Recombinant Human Endostatin|The initial dose of PEDylated Recombinant Human Endostatin (M2ES) will be 7.5mg/m2.Dose Escalation to a next higher level will occur when 3 patients in the same dose level complete 28 days of continuous treatment without experiencing a dose-limiting toxicity.
16217216|NCT01260012|Dietary Supplement|Praziquantel+antioxidant suppl|Praziquantel therapy will be offered at the start, at six weeks and at 12 weeks from date of enrollment. Thereafter praziquantel therapy will be offered if subjects have demonestrable S. mansoni eggs on the subsequent six-monthly evaluations. In addition subjects will receive antioxidant supplement on daily basis for a period of one year.
16217217|NCT01260012|Other|Praziquantel + placebo 2mths then antioxidant for 10 mths|Praziquantel therapy will be offered at the start, at six weeks and at 12 weeks from date of enrollment. Thereafter praziquantel therapy will be offered if subjects have demonestrable S. mansoni eggs on the subsequent six-monthly evaluations. In addition subjects will receive placebo as a supplement for two months which will be followed by antioxidant as a supplement for the rest of the year.
16217218|NCT01260012|Dietary Supplement|Praziquantel therapy and placebo as supplement|Praziquantel at day 0, 6-weeks and at 12 weeks from start of study. Thereafter praziquantel therapy will be offered if subjects have demonestrable s.mansoni eggs on six-monthly evaluation periods. Placebo will be given as a supplement for one year.
16217219|NCT01260012|Dietary Supplement|Praziquantel+antioxidant|Praziquantel treatment will be offered at time 0, six weeks and 12 weeks from the start. Antioxidant supplement will be offered on a daily basis for a period of one year
16217220|NCT01259999|Dietary Supplement|Calogen extra strawberry|A daily dose of 3 x 30 ml Calogen extra strawberry flavour will be distributed at the same time as the medicines i.e. at 8.00, 12.00 and 20.00.
16217221|NCT01259986|Procedure|Laser treatment|Laser treatment of using 635 nm laser with a dose of 3.0 J/cm^2 to small area (2cm x 2cm) of vitiligo once to twice a week for a total of 12 weeks.
16217222|NCT01259973|Drug|Risperidone|1 single dose of 2.5mg masked in 250 mL of peach juice, for 1 day. Oral administration.
16217223|NCT01259973|Drug|Placebo|1 single dose of 2.5mL physiological serum masked in 250 mL of peach juice, for 1 day. Oral administration.
16217224|NCT01259973|Drug|Haloperidol|1 single dose of 5mg masked in 250 mL of peach juice, for 1 day. Oral administration.
16217225|NCT01259947|Drug|Lippia alba (Mill.) N. E. Brown ethanolic extract|1-2 drops per kilogram per day, PO, twice a day
16217226|NCT01259934|Drug|Interferon-alpha2b - 1 year|Induction: IFN-alpha2b, 10 MU (flat dose), SC, 5 days/week, 4 weeks Maintenance: IFN-alpha2b, 10 MU (flat dose), 3 days/week, SC, 12 months
16217227|NCT01259934|Drug|Interferon-alpha2b - 2 years|Induction: IFN-alfa2b, 10 MU (flat dose), SC, 5 days/week, 4 weeks Maintenance: IFN-alfa2b, 10 MU (flat dose), 3 days/week, SC, 24 months
16217228|NCT01259921|Behavioral|neurofeedback|Operant conditioning of the EEG provided by computer reinforcement.
16217229|NCT01259908|Procedure|Laparoscopic vs open Ygraft|Patients with aorto-iliac occlusive disease TASC type D operated with either laparoscopic aortobifemoral bypass or open aortobifemoral bypass shall be compared.
16217230|NCT01259882|Drug|PF-05089771|Subjects will receive single ascending doses of PF-05089771 or placebo to investigate the safety/tolerability and PK of PF-05089771. The PK of alternative formulations of PF-05089771 and the effect of food on PK may also be investigated.
16217231|NCT01259882|Drug|PF-05089771|Subjects will receive single ascending doses of PF-05089771 or placebo to investigate the safety/tolerability and PK of PF-05089771. The PK of alternative formulations of PF-05089771 and the effect of food on PK may also be investigated.
16217232|NCT01259882|Drug|PF-05089771|Subjects will receive single doses of PF-05089771 or placebo in a fully randomized crossover design. The investigation of the safety/tolerability and PK of PF-05089771 will occur. In addition the exploratory pharmacodynamics of PF-05089771 will be investigated using novel biomarkers.
16217233|NCT01259882|Drug|PF-05089771|Subjects will receive single doses of PF-05089771 or placebo in a fully randomized crossover design. The investigation of the safety/tolerability and PK of PF-05089771 will occur.
16217234|NCT01259882|Drug|PF-05089771|Subjects will receive single doses of PF-05089771 or placebo in a fully randomized crossover design. The investigation of the safety/tolerability and PK of PF-05089771 will occur.
16217235|NCT01259882|Drug|PF-05089771|Subjects will receive single doses of PF-05089771 or placebo in a fully randomized crossover design. The investigation of the safety/tolerability and PK of PF-05089771 will occur.
16217236|NCT01259869|Drug|PX-866|1 cycle = 8 weeks on study PX-866 - 8mg PO Daily
16217237|NCT01259856|Drug|PEGASYS|The subject will begin receiving the PEGASYS at a dose level of 45 micrograms weekly and gradually get increased to the maximum dose of 180 micrograms per week. The dose will be administered by prefilled syringes that will be injected subcutaneously. Subjects will receive therapy for up to 12 months.
16217238|NCT01259856|Drug|Hydroxyurea|Subjects will receive a 500mg tablet to be taken twice daily for up to 12 months of treatment.
16217239|NCT01259856|Drug|Aspirin|Subject will be asked to take 81 to 100mg per day for the 12 months of the study treatment.
16217240|NCT01259830|Drug|Arcoxia®120 mg|Arcoxia® over encapsulated 120 mg; Perioperatively 6 days 1 tablet (Arcoxia® 120 mg) for oral use
16217241|NCT01259830|Drug|P Tablet White Lichtenstein|P Tablet White Lichtenstein over encapsulated; Perioperatively 6 days 1 tablet for oral use
16217242|NCT01259817|Drug|PEGASYS|Patient will start at 45 micrograms per week and gradually increase to 180 micrograms per week. Pegasys will be supplied in prefilled syringes and are to be given subcutaneously.
16217243|NCT01259817|Drug|Aspirin|81 or 100 mg daily.
16217245|NCT01259791|Drug|Individual-specific statin causing myopathy|Individual-specific statin causing myopathy vs. placebo
16217246|NCT01259791|Drug|Placebo|Placebo
16217247|NCT01259765|Drug|VHH batch 203027|The active product is 165 mg of VHH batch 203027 and 835 mg maltodextrin with 0.5% (w/w) caramel colour in 10 mL ORS. The osmolality (concentration of the osmotically active substances in the solution such as sugar molecules, salts etc. ) of this solution will be around 60 mOsmol/kg. The mixture of the 165 mg of VHH batch 203027 and 835 mg maltodextrin (0.5% (w/w) caramel colour will be provided per sachet.
16217248|NCT01259765|Drug|Placebo product|The Placebo treatment consisted of 1000 mg of maltodextrine with 5% (w/w) caramel colour in 10 mL ORS.
16217249|NCT01259752|Device|compression stockings|compression stockings
16217250|NCT01259752|Other|standard non compressive stockings|standard non compressive stockings
16217251|NCT01259739|Other|Cocoa|dissolved in water twice-daily intervention
16217252|NCT01259726|Biological|VP20621|VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for seven days
16217253|NCT01259726|Biological|VP20621|VP20621 as oral liquid once daily for 7 days followed by placebo as oral liquid once daily for 7 days
16217254|NCT01259726|Other|Placebo|10 mL placebo once daily for 14 days
16217255|NCT01259726|Biological|VP20621|VP20621 as oral liquid once daily for 14 days
16217256|NCT01259713|Drug|Liposomal amphotericin B|Ambisome 5 mg/kg twice weekly administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week during induction chemotherapy
16217257|NCT01259713|Drug|Placebo|Placebo to match liposomal amphotericin B administered by IV route over 2 hours twice weekly (each dose separated alternately by 2 and 3 days each week) during induction chemotherapy
16217258|NCT01259700|Behavioral|High-risk patient standardized management package|A primary-care based high cardiovascular risk management package delivered by village doctors
16217259|NCT01259700|Behavioral|Community based salt reduction program|A community-based salt reduction program delivered mainly by community health educators
16217260|NCT01259687|Device|Non-invasive cardiac output monitoring|During the surgery the continuous monitoring of blood pressure by peripheral artery catheter and cardiac output by NICOM (non-invasive cardiac output monitoring) will be applied. In case of intraoperative hemodynamic changes (hypertension, hypotension) the patient will be treated according to the standard care by Phenylephrine, Nitroglycerine or Colloid fluid boluses. Cardiac output will be measured by NICOM just before and after each treatment of hemodynamic events that described above. Simultaneous records of ECG, arterial and plethysmographic waveforms will be made just before and after each event. Systolic blood pressure and PuTT will be measured OFFLINE from the recorded waveforms
16217261|NCT01259674|Device|AboMeg-B-09|Syrup: AboMeg-B-09 5ml to be taken 4 times a day during the entire study period
16217262|NCT01259674|Other|Placebo|Placebo syrup: 5ml to be taken 4 times a day during the entire study period
16217263|NCT01259661|Other|A longitudinal intervention|In our longitudinal intervention study, all eligible subjects will undergo a physical examination by a physician to rule out obvious secondary causes of hypertension and contraindications to exercise. Randomization will be performed by random member generation. The exercise participants will attend three sessions per week at the facility during the study period. Training intensity is initially set at heart rate equivalent to 60% and progress to 80% of each subject's maximal heart rate reserve for 30 min/day with a frequency of 3 days/wk. Facility-based exercise sessions will consist of treadmill walking.
16217264|NCT01259648|Drug|0.5 µg/kg remifentanil|0.5 µg/kg remifentanil is used during induction in addition to the classic induction protocol
16217265|NCT01259648|Drug|1.0 µg/kg remifentanil|1.0 µg/kg remifentanil is added to the classic induction anesthesia protocol
16217266|NCT01259648|Drug|NaCl|an equivalent volume (1 ml for 10 kg of weight) of 0.9% isotonic NaCl is injected in addition to the classic anesthesia induction protocol
16217267|NCT01259635|Device|Biofeedback auditory stimulation|Whenever freezing episodes occures, a metronom sound will be heard.
16217268|NCT01259622|Drug|saline|intravenous infusion
16217269|NCT01259622|Drug|K201|intravenous infusion
16217270|NCT01259609|Procedure|Pars Plana Vitrectomy|25-gauge three-port pars plana vitrectomy
16217271|NCT01259596|Behavioral|cognitive behavioral therapy|weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
16217272|NCT01259596|Behavioral|nondirective supportive therapy|weekly individual psychotherapy by telephone for 12 weeks; 4 booster sessions
16217273|NCT01259583|Procedure|CO2|CO2 insufflation
16217274|NCT01259583|Procedure|Warm water|warm water irrigation
16217275|NCT01259570|Dietary Supplement|Group 1|Skimmilk enriched with VD encapsulated in CM
16217276|NCT01259570|Dietary Supplement|Group 2|VD will be dissolved in milkfat and homogenized into skimmilk
16217277|NCT01259570|Dietary Supplement|group 3|3% fat milk wherein the VD will be in CM
16217278|NCT01259570|Dietary Supplement|Group 4|Placebo: un-enriched skimmilk.
16217279|NCT01259557|Drug|Botulinum Toxin Type A|2 times, Intra-muscular injection, Maximum dosage total 60U
16217280|NCT01259544|Drug|benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)|300 mg of powder form dissolved in one cup of tap water prior to breath test
16217281|NCT01259544|Drug|benzoyl-L-tyrosyl-[1-13C]alanine (Bz-Tyr-Ala)|300 mg of 13 C di peptide in single dose powder form dissolved in one cup of tap water.
16217282|NCT01259531|Drug|Silodosin|Silodosin will be administered during 12 weeks, 8 mg (4 mg x 2 cap) QD with morning meal.
16217283|NCT01259518|Drug|TRIN2755|In treatment schedule A (Group A), the planned starting dose to be investigated is 25 mg TriN 2755 given once followed by a recovery period of 4 weeks. Subsequent patients can only be included on a new dose level when the safety review from all patients included at the preceding dose level(s) at Day 28 after infusion (end of Cycle 1) does not indicate relevant toxicity.
16217284|NCT01259518|Drug|TRIN2755|In treatment schedule B (Group B), the starting dose to be investigated is 800mg, given once every 7 days in a 4 week cycle. Subsequent patients can only be included on a new dose level when the safety review from all patients included at the preceding dose level(s) at Day 28 after the start of the first infusion (end of Cycle 1) does not indicate relevant toxicity.
16217323|NCT01259245|Other|Tai chi + PRP|The exercise content was totally identical to PRP group except 15 minutes of 5 Sun Style Tai Chi were substituted to 15 minutes of relaxation exercise
16217285|NCT01259505|Biological|CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1|CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 peptides mixed with Montanide ISA 51 Patients will be vaccinated once a week until patients develop progressive disease or unacceptable toxicity. On each vaccination day, CDCA1，URLC10，KIF20A，DEPDC1 and MPHOSPH1 peptides (0.5, 1 or 2mg of each peptide) mixed with Montanide ISA 51 will be administered by subcutaneous injection.
16217286|NCT01259492|Drug|Placebo|Placebo Comparator: Placebo
16217287|NCT01259492|Drug|Ritalin LA 20 mg|Ritalin LA (a racemic mixture of d- and l-thre-Methylphenidate Hydrochloride (MPH), extended release hard capsules) taken orally once daily in doses of 40, 60, or 80 mg.
16217288|NCT01259492|Drug|Ritalin LA 30 mg|Ritalin LA (a racemic mixture of d- and l-thre-Methylphenidate Hydrochloride (MPH), extended release hard capsules) taken orally once daily in doses of 60, or 80 mg.
16217289|NCT01259479|Drug|Satraplatin|Orally, once daily for 5 days repeated every 28 days, dose-escalation
16217290|NCT01259466|Drug|Nicotine patch|Transdermal Nicotine Replacement Therapy - 21 mg daily for 10 weeks
16217291|NCT01259453|Biological|Vaccination to prevent hepatitis B virus infection|Standard dosing with Twinrix; comparison of standard and acceleration dosing schedule
16217292|NCT01259440|Behavioral|Video Teleconferencing Care|The core component of the VTC intervention is the frequent contact between patient and provider using a telemedicine system that allows for audio-visual communication.
16217293|NCT01259440|Behavioral|Usual Care|Consists of one week telephone call and one month clinic visit
16217294|NCT01259427|Behavioral|Ending Self Stigma (ESS)|Ending Self Stigma (ESS) is a 9-session small-group (4-8 persons) course designed to help individuals with serious mental Illness (SMI) develop skills to effectively cope with stigma and minimize the internalization of stigmatizing beliefs and stereotypes. Sessions combine in-class lecture, discussion of relevance to group members' personal experiences, review and practice of strategies and skills, and group sharing, support, and problem-solving. Each session is designed to focus on a specific strategy for addressing self-stigma.
16217295|NCT01259427|Behavioral|Health and Wellness Group|The Health and Wellness group is a 9-session small-group (4-8 persons) course designed for individuals with serious mental illness (SMI). Each session focuses on discussion of specific health and wellness related issues and education on ways to better manage health related concerns (e.g., physical activity/exercise, nutrition, managing fatigue/sleep, tobacco and other substance use, etc).
16217296|NCT01259414|Other|Solvent with specific gravity less than lipiodol|TACE with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg)dissolved in distilled water and emulsified lipiodol followed embolization with polyvinyl alcohol particles (PVA)
16217297|NCT01259414|Other|Solvent with specific gravity equivalent to lipiodol|TACE with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg)dissolved in water-soluble contrast medium and distilled water,then emulsified with lipiodol followed embolization with polyvinyl alcohol particles (PVA)
16217298|NCT01259401|Behavioral|Sleep Intervention Program|Sessions focused on: 1) sleep consolidation and sleep schedule optimization, 2) sleep hygiene education, 3) cognitive therapy, and 4) maintenance of sleep improvements and coping with future bouts of insomnia.
16217299|NCT01259401|Behavioral|Sleep Education control|During sessions, participants reviewed two educational brochures that focused on changes in sleep with age and sleep hygiene education.
16217300|NCT01259388|Drug|Lithium Carbonate|Lithium carbonate is dosed at 150 or 300 mg daily, as tolerated by study subjects, for one year's time.
16217301|NCT01259375|Drug|Amrubicin|Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously
16217302|NCT01259362|Procedure|Transcranial Magnetic Stimulation|5 Hz, 120 % motor threshold, intertrain interval 20s, number of pulses in train 50.
16217303|NCT01259362|Procedure|Transcranial Magnetic Stimulation|Cocaine addicted will receive 20 sham TMSr
16217304|NCT01259349|Procedure|one percent ultrasound power in CMICS|Co-axial MICS shall be performed in cases allocated to this arm .The ultrasound power shall be kept at one percent during the surgery.A note of effective phacotime,volume of fluid aspirated and any intraoperative complications shall be made.
16217305|NCT01259349|Procedure|40 percent ultrasound power in CMICS|Co-axial MICS shall be performed in cases allocated to this arm .The ultrasound power shall be kept at 40 percent during the surgery.A note of effective phacotime,volume of fluid aspirated and any intraoperative complications shall be made.
16217306|NCT01259336|Drug|Itraconazole|Tablet 200 mg twice daily for 6 months
16217307|NCT01259336|Drug|treatment in cavitary pulmonary aspergillosis|Anti-tussive, blood transfusion, surgical resection and bronchial artery embolisation(BAE)
16217308|NCT01259323|Biological|REGN668|Dose 1: REGN668 or placebo
16217309|NCT01259323|Biological|REGN668|Dose 2: REGN668 or placebo
16217310|NCT01259323|Biological|REGN668|Dose 3: REGN668 or placebo
16217311|NCT01259297|Drug|Aliskiren|Aliskiren 150/300 mg once daily
16217312|NCT01259297|Drug|Amlodipine|Amlodipine 5 mg
16217313|NCT01259297|Drug|Hydrochlorothiazide (HCTZ)|HCTZ 12.5/25 mg
16217314|NCT01259297|Drug|Placebo for Aliskiren|Placebo for Aliskiren 300 mg
16217315|NCT01259297|Drug|Placebo for Amlodipine|Placebo for Amlodipine
16217316|NCT01259297|Drug|Placebo for Hydrochlorothiazide (HCTZ)|Placebo for HCTZ 12.5/25 mg
16217317|NCT01259284|Drug|Atorvastatin|1 capsule by mouth every morning 5 days before surgery, and 9 days after surgery or until discharge.
16217318|NCT01259284|Dietary Supplement|Fish Oil Supplement|3 capsules by mouth in the morning and evening 5 days before surgery, and 9 days after surgery or until discharge.
16217319|NCT01259284|Other|Placebo|"Placebo group: 4 capsules by mouth every morning and 3 every evening for 5 days before surgery and 9 days after surgery or until discharge.
~Atorvastatin group: 3 capsules by mouth every morning and evening, 5 days before surgery and 9 days after surgery or until discharge.
~Fish Oil Supplement group: 1 capsule by mouth every morning 5 days before surgery and 9 days after surgery or until discharge."
16217320|NCT01259271|Device|Selective Nerve Stimulation (SNS) stimulator device|Two hours per study visit separated by a minimum of a 20 hour wash out period between stimulations.
16217321|NCT01259258|Procedure|without dye varicocelectomy|40 controls in whom no mapping technique was adopted in the period between
16217322|NCT01259258|Procedure|without dye varicocelectomy|40 controls in whom no mapping technique was adopted in the period between
16217365|NCT01258855|Biological|Aldesleukin|Given IV
16217366|NCT01258855|Other|Laboratory Biomarker Analysis|Correlative studies
16217324|NCT01259245|Other|PRP|Formal pulmonary rehabilitation program consisted of overview of COPD management, aerobic exercises, breathing control exercises, Thera-Band strengthening exercises, safety precautions for physical training and goal setting
16217325|NCT01259219|Drug|Mycobutin|"Indication and Usage:
~Mycobutin capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV Infection.
~Dosage and Directions for use:
~Mycobutin cab be administred as a single daily dose, independent of meals. In all cases Mycobutin is to be administred in combination regimens.
~Identification:
~Red-brown, self locking, hard gelatin capsule, size 0, containing a violet powder."
16217326|NCT01259193|Drug|Sorafenib and Zoledronic Acid|Sorafenib ,tablet,400mg Bid ,until patient can not tolerance Zoledronic Acid ,powder for injection,4mg per 3 week for 1 year
16217327|NCT01259180|Procedure|acupuncture treatment|twice a week, 6 weeks, 12sessions penetrating skin with stailess steel acupuncture device(diameter: 0.25-0.3mm,legth: 30-70mm) points: BL 23,BL31,BL32, BL40, BL53, GB30, SP 6 bilaterally plus Ashi. with
16217328|NCT01259180|Procedure|Sham acupunture|twice a week, 6 weeks, 12 sessions not penetrating skin with dull acupuncture device(Park Sham device :Acuprime Co. Ltd, UK) point: 1~2inches away from real acupuncture point
16217329|NCT01259141|Drug|Moxifloxacin|0.4 Qd for 7days
16217330|NCT01259141|Drug|Cephalosporins and azithromycin|cefuroxime 1.5 bid for 7 days plus azithromycin 0.5 qd for 7 days
16217331|NCT01259128|Drug|SER120 Nasal Spray 500 ng/day|SER120 Level 1
16217332|NCT01259128|Drug|SER120 nasal spray 750 ng/day|SER120 (750 ng/day)
16217333|NCT01259115|Drug|Buprenorphine transdermal patch|Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear.
16217334|NCT01259115|Drug|Ketoconazole tablet|Ketoconazole 200 mg tablets taken orally twice daily.
16217335|NCT01259115|Drug|Placebo to match ketoconazole tablet|Placebo to match ketoconazole 200 mg tablets taken orally twice daily.
16217336|NCT01259102|Drug|Buprenorphine transdermal patch|Buprenorphine 10 mcg/hour patch applied transdermally for 7-day wear.
16217337|NCT01259089|Drug|erlotinib hydrochloride|Given orally
16217338|NCT01259089|Drug|Hsp90 inhibitor AUY922|Given IV
16217339|NCT01259089|Other|laboratory biomarker analysis|Correlative studies
16217340|NCT01259089|Procedure|needle biopsy|Undergo image-guided needle biopsy (correlative studies)
16217341|NCT01259089|Genetic|mutation analysis|Correlative studies
16217342|NCT01259089|Other|pharmacological study|Correlative studies
16217343|NCT01259076|Procedure|magnetic resonance imaging|Undergo MRI at baseline and 1 year later.
16217344|NCT01259076|Procedure|digital mammography|Undergo digital mammography at baseline and 1 year later.
16217345|NCT01259076|Procedure|conventional surgery|Undergo gastric bypass surgery
16217346|NCT01259063|Drug|Everolimus and Intravesical Gemcitabine|Phase I: Everolimus will be adm as follows: Dose level 1: 5 mg every other day, Dose level 2: 5 mg daily, Dose level 3: 10 mg daily Phase II: Everolimus will be adm at 10 mg daily the dose determined in Phase I. Pts will receive a dose of 2000 mg of intravesical gemcitabine twice a week (72-96 +8 hours between doses) for 3 weeks for a total of 6 treatments in course 1. After 1 week of rest from intravesical gemcitabine, course 2 will be administered, provided the treating physician notes acceptable pt tolerance. The total number of intravesical instillations will be 12. There will be no dose modifications to gemcitabine; however, pts will be allowed to skip gemcitabine doses if needed, per the treating physician's discretion. Missed or skipped doses of gemcitabine will not be repeated. The pt will receive as many instillations as tolerable up to the maximum of 12 instillations.
16217347|NCT01259050|Drug|Zinc and Copper|Optizinc 90 mg/d Copper 1 mg
16217348|NCT01259024|Device|transarterial chemoembolization using a drug-eluting bead|Up to 2 vials of LC Beads will be administered. One 2 mL vial each of 300-500 and 500-700 um LC Beads with 37.5 mg/mL doxorubicin will be prepared and mixed with radiographic contrast. Under fluoroscopic control, the vial of 300-500 um vial will be infused, followed by the vial of 500-700 um LC Beads. If the artery does not reach stasis prior to administration of both vials, and there is residual antegrade flow in the feeding artery, it will be treated with bland embolization similar to chemoembolization.
16217349|NCT01259011|Behavioral|the SPIRIT intervention|the SPIRIT intervention (Sharing the Patient's Illness Representation to Increase Trust) to improve discussions about end-of-life care between patients and their surrogate decision makers
16217350|NCT01258998|Drug|Akt inhibitor MK2206|Given PO
16217351|NCT01258998|Other|laboratory biomarker analysis|Correlative studies
16217352|NCT01258985|Behavioral|Tai Chi|12 weeks of Tai Chi
16217353|NCT01258985|Behavioral|Physical Therapy|6 weeks of individualized Physical Therapy followed by 6 weeks of supervised Home Exercise
16217354|NCT01258972|Device|Tryton Side Branch Stent with main branch DES|Tryton Side Branch Stent
16217355|NCT01258972|Device|POBA|Balloon angioplasty
16217356|NCT01258959|Procedure|Ultrasound detection of local anesthetics spread|During the parabulbar injection the ultrasound operator experienced in ultrasound guided retrobulbar block will assess whether there is spread of local anaesthetic in the central cone just behind the sclera (yes or no). The anaesthesist performing the block will be blinded to the ultrasound visualized spread of local anaesthetic.
16217357|NCT01258933|Drug|Ofatumumab|300 mg Dose 1, then 1,000 mg weekly x 7, (treatment) then 1,000 mg every 2 months beginning on week 12
16217358|NCT01258920|Drug|Paliperidone palmitate|Paliperidone palmitate will be administered im as an initial loading dose of 150 mg eq. on Day 1 and 100 mg eq. 1 week later in the deltoid muscle, and will be administered in a flexible dose range of 25 to 150 mg eq. at 4-week intervals from Week 5 for a total of 11 injections.
16217359|NCT01258907|Drug|MLDL1278A|Single intravenous dose
16217360|NCT01258907|Drug|MLDL1278A|Repeating intravenous dose
16217361|NCT01258907|Drug|placebo|Repeating intravenous dose
16217362|NCT01258907|Drug|statin, stable dose|Repeating oral dose
16217363|NCT01258868|Drug|Celebrex|400 mg PO BID for 7 days prior to cell administration and then on days 1 through 28 of each vaccine cycle.
16217364|NCT01258868|Biological|Tumor cell vaccine|A minimum of 1x10e7 and a maximum of 1x10e8 patient tumor cells that have been exposed to 1 mcM decitabine for 6 days, exposed to 100 Gy radiation and emulsified in 0.5 ml of the ISCOMATRIX adjuvant at a concentration of 180 ISCO units/mL administered IM every 4 weeks for 6 injections; if subject shows immune response, vaccine will be given every three months from months 9 - 24
16217368|NCT01258842|Dietary Supplement|Bifidobacterium lactis HN019|B. lactis HN019 (5 billion cfu / day) sachet, consumed once per day for 12 weeks
16217369|NCT01258842|Dietary Supplement|Placebo|Placebo sachet, consumed once per day for 12 weeks
16217370|NCT01258829|Other|Non-invasive haemodynamic optimisation|Comparing the method of non-invasive haemodynamic
16217371|NCT01258829|Other|ECHO optimisation|Standard ECHO optimisation method
16217372|NCT01258816|Drug|Elacytarabine for infusion|Elacytarabine 2000 mg/m2/d will be administered as a continuous intravenous infusion (CIV) in a d 1-5 q3w schedule.
16217373|NCT01258803|Drug|Formoterol Fumarate DPI|Two inhalations of Formoterol Fumarate DPI 10 mcg administered as a single dose
16217374|NCT01258803|Drug|Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer|Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
16217375|NCT01258803|Drug|Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer|Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
16217376|NCT01258803|Drug|Placebo MDI with spacer|Two inhalations of placebo MDI administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
16217377|NCT01258803|Drug|Placebo MDI without spacer|Two inhalations of placebo MDI administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer)
16217378|NCT01258803|Drug|Mometasone Furoate DPI|Two inhalations of MF DPI 100 mcg administered as a single dose once daily at night. Used as maintenance therapy during screening and in between single doses of study drug.
16217379|NCT01258790|Device|Sham Repetitive Transcranial Magnetic Stimulation|Repetitive Transcranial Magnetic Stimulation (RTMS) is a relatively new technology that allows for targeted noninvasive stimulation of the brain. RTMS is currently FDA-cleared for the treatment of refractory depression. It is also used experimentally to treat seizures, spasticity, dystonia and other neuropsychiatric conditions. The Sham intervention uses a sham magnetic coil.
16217380|NCT01258790|Device|Active Repetitive Transcranial Magnetic Stimulation|Repetitive Transcranial Magnetic Stimulation (RTMS) is a relatively new technology that allows for targeted noninvasive stimulation of the brain. RTMS is currently FDA-cleared for the treatment of refractory depression. It is also used experimentally to treat seizures, spasticity, dystonia and other neuropsychiatric conditions. The Active intervention uses an active magnetic coil.
16217381|NCT01258777|Drug|400 mg golimumab or placebo|Single dose of 400 mg subcutaneously
16217382|NCT01258777|Drug|200 mg golimumab or placebo|Single dose of 200 mg subcutaneously
16217383|NCT01258764|Drug|Lisinopril|Lisinopril 10 mg oral, once daily for four week cycle and a 2 week cycle
16217384|NCT01258764|Drug|Hydrochlorothiazide|Hydrochlorothiazide 25 mg oral, once daily for 4 week cycle and a 2 week cycle
16217385|NCT01258751|Drug|PF-05212377|Single dose of up to 70 mg PF-05212377, delivered as .25 mg, 5 mg and/or 15 mg on study day 1
16217386|NCT01258738|Biological|etanercept|In Period 1, subjects will receive in a prefilled syringe with 1.0 ml (test article Etanercept (SC) once weekly . Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician.
16217387|NCT01258738|Drug|Background NSAID|Subject will continue to take a concomitant background non steroidal anti inflammatory drug(NSAID)as prescribed by their attending physician. The name and dose of this NSAID is the decision of the attending physician.
16217388|NCT01258738|Other|PLACEBO|In Period 1 will receive a prefilled syringe of Placebo for Etanercept Additionally they will continue to take the background non steroidal anti inflammatory drug(NSAID) in the tolerated dose agreed upon by the attending Physician.
16217389|NCT01258738|Drug|Background NSAID|Subject will continue to take a concomitant background non steroidal anti inflammatory drug(NSAID)as prescribed by attending physician (dose drug selection as tolerated and agreed upon by the attending Physician).
16217390|NCT01258725|Procedure|amnioinfusion procedure|Single/serial amnioinfusions aimed at restoring amniotic fluid volume until a normal amount (AFI≥8cm).(Every pregnant women presenting with severe (AFI<5) idiopathic (with unknown origin) oligohydramnios is treated with amnioinfusion at our Dept.)
16217391|NCT01258712|Drug|Tocilizumab + methotrexate(MTX)|Tocilizumab:8 mg/kg every4weeks,IV infusion methotrexate:10-20 mg/week
16217392|NCT01258712|Drug|Tocilizumab placebo + methotrexate(MTX)|Tocilizumab placebo:8 mg/kg every 4 weeks,IV infusion methotrexate:10-20 mg/week
16217393|NCT01258699|Drug|Thiocacid HR Tab 600mg|600mg for 1 day
16217394|NCT01258699|Drug|BK-C-0701 320mg|320mg for 1 day
16217395|NCT01258699|Drug|BK-C-0701 480mg|480mg for 1 day
16217396|NCT01258686|Drug|Silymarin|700mg thrice daily
16217397|NCT01258686|Drug|Placebo|Placebo 700mg thrice daily
16217398|NCT01258673|Drug|Fimasartan/HCTZ combination|Fimasartan/HCTZ combination 60/12.5mg 120/12.5mg
16217399|NCT01258673|Drug|Fimasartan|Fimasartan 60mg, 120mg
16217400|NCT01258660|Drug|EE 0.03 mg/DRSP 3 mg/Metafolin + folic acid placebo|Combination EE/DRSP/ Metafolin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin] given orally in a cyclic regimen for 24 weeks (6 cycles) in combination with folic acid placebo tablets (encapsulated). Each treatment cycle consisting of once daily hormone and Metafolin treatment for 21-days followed by once daily hormone free, Metafolin only regimen for 7 days. This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
16217401|NCT01258660|Drug|EE 0.03 mg/DRSP 3 mg (Yasmin) + folic acid|Yasmin [0.030 mg ethinylestradiol (EE) + 3 mg drospirenone (DRSP)] in combination with folic acid tablets 0.4 mg (encapsulated), given orally in a cyclic regimen for 24 weeks (6 cycles). Each treatment cycle providing once daily hormone and folic acid treatment for 21 days followed by once daily hormone free, folic acid only regimen for 7 days (encapsulated). This phase was followed by 20 weeks (5 cycles) folate elimination phase consisting of oral administration of Yasmin alone.
16217402|NCT01258647|Dietary Supplement|caterpillar cereal|A 30 gram portion of a cereal containing one part dried, ground caterpillar, one part corn flour and small quantities of sugar and palm oil will be evaluated by the mothers and then fed daily for seven days to infants.
16217479|NCT01258075|Drug|Low-dose colesevelam|0.625 grams colesevelam hydrochloride in oral suspension
16217403|NCT01258634|Drug|Dexrazoxane|"Preoperative Chemotherapy Courses 1, 2, 3, 4: 750mg/m2; IV over 15 minutes on day 1
~Postoperative Chemotherapy for Good Responders Courses 1 and 2: 750mg/m2 IV over 15 minutes on Day 1
~Postoperative Chemotherapy for Poor Responders Courses 2 and 4: 750mg/m2 IV over 15 minutes on Day 1"
16217404|NCT01258634|Drug|Doxorubicin|"Preoperative Chemotherapy Courses 1 and 3: 75mg/m2; IV push day 1 Courses 2 and 4: 75mg/m2; IV push day 1, hour 0
~Postoperative Chemotherapy for Good Responders Course 1: 75mg/m2; IV push day 1 Course 2: 75mg/m2; IV push day 1, hour 0
~Postoperative Chemotherapy for Poor Responders Course 2: 75mg/m2; IV push day 1 Course 4: 75mg/m2; IV push day 1, hour 0"
16217405|NCT01258634|Drug|Cisplatin|"Preoperative Chemotherapy Courses 1 and 3: 60mg/m2 daily x 2 days, in 1000 ml D5W NS + 10g/m2 mannitol
~Postoperative Chemotherapy for Good Responders Courses 1 and 2: 60mg/m2 daily x 2 days, in 1000 ml D5W NS + 10g/m2 mannitol
~Postoperative Chemotherapy for Poor Responders:
~Course 2: 60mg/m2 daily x 2 days, in 1000 ml D5W NS + 10g/m2 mannitol"
16217406|NCT01258634|Drug|G-CSF|"Preoperative Chemotherapy Courses 1, 2, 3, and 4: 5mcg/Kg; IV/SQ starting 24 hours after chemotherapy until WBC >10,000
~Postoperative Chemotherapy for Good Responders Courses 1, 2, and 3: 5mcg/Kg; IV/SQ starting 24 hours after chemotherapy until WBC >10,000
~Postoperative Chemotherapy for Poor Responders Courses 2, 4, and 5: 5mcg/Kg; IV/SQ starting 24 hours after chemotherapy until WBC >10,000"
16217407|NCT01258634|Drug|PEG-filgrastim|"Preoperative Chemotherapy Courses 1, 2, 3, and 4: 6mg; SQ starting 24 hours after chemotherapy
~Postoperative Chemotherapy for Good Responders Courses 1, 2, and 3: 6mg; SQ starting 24 hours after chemotherapy
~Postoperative Chemotherapy for Poor Responders Courses 2 and 4: 6mg; SQ starting 24 hours after chemotherapy"
16217408|NCT01258634|Drug|Etoposide|"Preoperative Chemotherapy Courses 2 and 4: 50mg/m2 on days 1, 2, 3, 4
~Postoperative Chemotherapy for Good Responders Course 2: 50mg/m2 on days 1, 2, 3, 4 Course 3: 50mg/m2 on days, 1, 2, 3, 4 Hour 0-1
~Postoperative Chemotherapy for Poor Responders Course 4: 50mg/m2 on days 1, 2, 3, 4 Course 5: 50mg/m2 on days 1, 2, 3, 4"
16217409|NCT01258634|Drug|Ifosfamide|"Preoperative Chemotherapy Courses 2 and 4: 3g/m2; IV over 1 hour Days 1, 2, 3, 4
~Postoperative Chemotherapy for Good Responders Course 2: 3g/m2; IV over 1 hour Days 1, 2, 3, 4 Course 3: 3g/m2; IV over 1 hour Days 1, 2, 3, 4
~Postoperative Chemotherapy for Poor Responders Course 4: 3g/m2; IV over 1 hour Days 1, 2, 3, 4 Course 5: 3g/m2; IV over 1 hour Days 1, 2, 3, 4"
16217410|NCT01258634|Drug|Mesna|"Preoperative Chemotherapy Courses 2 and 4: 600mg/m2, 1st dose in bag with ifosfamide, 2nd dose IV over 3 hours immediately post ifosfamide infusion, Subsequent doses - hour 5, 8, 11, 14 (IV push)
~Postoperative Chemotherapy for Good Responders Courses 2 and 3: 600mg/m2, 1st dose in bag with ifosfamide, 2nd dose IV over 3 hours immediately post ifosfamide infusion, Subsequent doses - hour 5, 8, 11, 14 (IV push)
~Postoperative Chemotherapy for Poor Responders Courses 4 and 5: 600mg/m2, 1st dose in bag with ifosfamide, 2nd dose IV over 3 hours immediately post ifosfamide infusion, Subsequent doses - hour 5, 8, 11, 14 (IV push)"
16217411|NCT01258634|Drug|Leucovorin|Postoperative Chemotherapy for Poor Responders Courses 1 and 3: 15 mg/m2/dose IV or PO every 6 hours, beginning 24 hours after start of methotrexate infusion and continuing until methotrexate level is <0.1 uM
16217412|NCT01258621|Procedure|Laparoscopy|Laparoscopic distal pancreatectomy
16217413|NCT01258608|Drug|Mapatumumab|Mapatumumab will be supplied as a lyophilized formulation in 10 mL vials containing 100 mg mapatumumab for intravenous infusion at the dose of 30 mg/kg.
16217414|NCT01258608|Drug|Placebo|Normal saline solution for intravenous infusion will be administered as placebo for mapatumumab
16217415|NCT01258608|Drug|Sorafenib|Sorafenib will be supplied as tablets, each containing 274 mg sorafenib tosylate, equivalent to 200 mg of sorafenib, to be administered 400 mg (2 x 200 mg tablets) orally twice daily.
16217416|NCT01258595|Biological|High-Dose Trivalent Inactivated Influenza Vaccine|0.5 mL Intramuscular
16217417|NCT01258595|Biological|Trivalent Inactivated Influenza Vaccine|0.5 mL, Intramuscular
16217418|NCT01258582|Procedure|Oral HIV screening|Participants will undergo oral HIV screening and, if positive, further study visits for up to 6 months
16217419|NCT01258582|Procedure|Fingerstick HIV screening|Participants will undergo fingerstick HIV screening and, if positive, further study visits for up to 6 months
16217420|NCT01258569|Drug|Entereg|Alvimopan (Entereg), an oral peripherally- acting mu-opioid receptor antagonist, is the first and only drug approved by the FDA to accelerate the time to upper and lower GI recovery in after partial large or small bowel resection surgery with primary anastomosis.
16217421|NCT01258569|Drug|Entereg|oral, 12 mg 30-300 min pre-op then BID up to 7 days (or 15 total doses)
16217422|NCT01258569|Drug|placebo|12 mg oral 30-300 min pre-op then BID up to 7 days (or 15 doses)
16217423|NCT01258556|Dietary Supplement|Yogurt supplemented with L. rhamnosus fiti|200 ml of L. rhamnosus fiti at 10*9 cfu/ml daily for 30 days.
16217424|NCT01258556|Dietary Supplement|Yogurt not supplemented with a probiotic strain.|200 ml yoghurt without L. rhamnosus fiti daily for 30 days.
16217425|NCT01258543|Other|General Osteopathic Evaluation|2 general osteopathic evaluations of approximately 1 hour in duration done consecutively on the same day with a 15 minute break between evaluations
16217426|NCT01258530|Drug|over-encapsulated oseltamivir|75 mg once
16217427|NCT01258530|Drug|oseltamivir|75 mg once
16217428|NCT01258517|Device|near infrared spectroscopy (INVOS 5100)|monitorization of cerebral oxygenation by INVOS 5100 during surfactant administration
16217429|NCT01258504|Drug|St. Johns Wort|"Administration of bosentan: 1 x 125 mg p.o. on days 1 and 20, 2 x 62.5 mg p.o. on day 2, 2 x 125 mg p.o. on days 3-19.
~Administration of SJW: 3 x 300 mg daily p.o. on days 11-19 and 2 x 300 mg on day 20"
16217430|NCT01258491|Drug|Nicotinic Acids|
16217431|NCT01258478|Other|Rehabilitation|Three weeks of outpatient, intensive physical rehabilitation before lung resection surgery.
16217432|NCT01258478|Other|Usual care|Usual care
16217433|NCT01258465|Behavioral|Pivotal Response Training|Naturalistic behavioral protocol designed to teach vocal communication.
16217434|NCT01258465|Behavioral|Picture Exchange Communication System|Pictorially-based behavioral protocol designed to teach communication to nonverbal children via pictures icons.
16217435|NCT01258452|Drug|CHF 5074|Drug is administered to subject in a fasting state
16217436|NCT01258452|Drug|CHF 5974|Drug is administered to subject after consumption of a high fat, high calorie meal
16217437|NCT01258439|Drug|raltegravir plus truvada|raltegravir 400 mg tablet with truvada 300/200 mg tablet for 24 weeks
16217438|NCT01258439|Drug|Darunavir, ritonavir, tenofovir/emtricitabine (Truvada)|Darunavir two 400mg tablets with one ritonavir 100mg capsule once daily plus Tenofovir/emtricitabine (Truvada) one 300mg/200mg tablet once daily with food for 24 weeks
16217439|NCT01258413|Procedure|Laparoscopic Radical Hysterectomy + pelvic lymphadenectomy|uterus, upper 1-2cm of vagina , parametrial tissue and uterosacral ligament + pelvic lymphadenectomy are removed by laparoscopic approach
16217440|NCT01258413|Procedure|Abdominal radical hysterectomy|uterus, upper 1-2cm of vagina , parametrial tissue and uterosacral ligament + pelvic lymphadenectomy are removed by abdominal approach
16217441|NCT01258387|Drug|Glial growth factor 2/ Neuregulin 1β3|
16217442|NCT01258387|Other|Placebo|
16217443|NCT01258374|Drug|Raltegravir|Raltegravir, 400 mg bid
16217444|NCT01258374|Drug|Darunavir|Darunavir, 800 mg QD + ritonavir 100 mg QD
16217445|NCT01258361|Procedure|echocardiography|Echocardiography is performed for all patients
16217446|NCT01258348|Drug|Drug: LY573636-sodium|"Participant specific dose based on height, weight and gender to target a specific exposure range, administered intravenously on Day 4 of a 42-day (6-week) cycle.
~Dose will be escalated to reach the maximum tolerated dose (MTD). A cohort of participants enrolled after MTD will receive albumin-tailored doses.
~Participants may continue on treatment until clinical or objective disease progression."
16217447|NCT01258348|Drug|Sunitinib|"37.5 or 50 milligrams (mg), administered orally, daily for a 42-day (6-week) cycle.
~Participants may continue on treatment until clinical or objective disease progression."
16217448|NCT01258335|Dietary Supplement|Omega 3|Omega-3-fatty acids 4 gm oral daily (Total:840mg EPA/2520mg DHA) (1:3 ratio of EPA to DHA) ( 6 capsules fatty acids)
16217449|NCT01258335|Other|Olive Oil|ii. Placebo oral daily (6 softgel capsules, each contains 1100 mg olive oil)
16217450|NCT01258322|Drug|Pioglitazone|The patients were randomized divided into 2 groups; one received no pioglitazone for lowing triglyceride, one with oral pioglitazone (Actos®, Takeda®) 15mg once daily for 12 weeks. After a four-week wash out, patients then continued with the alternate therapy.
16217451|NCT01258309|Drug|olopatadine hydrochloride /ketorolac tromethamine fixed dose combination ophthalmic solution|One drop of olopatadine hydrochloride/ketorolac tromethamine fixed dose combination ophthalmic solution administered to each eye, twice daily for 21 days.
16217452|NCT01258309|Drug|olopatadine hydrochloride 0.1% ophthalmic solution|One drop of olopatadine hydrochloride 0.1% ophthalmic solution administered to each eye, twice daily for 21 days.
16217453|NCT01258296|Drug|Fentanyl|25 mcg/hr transdermal patch
16217454|NCT01258296|Drug|Inactive patch|placebo patch (no drug)
16217455|NCT01258283|Other|Addional imaging|All patients will systematically have an 18F-FDG PET-CT (18F-fluorodeoxyglucose positron emission tomography/computed tomography) and a 123MIBG (Iodine 123 metaiodobenzylguanidine) scintigraphy
16217456|NCT01258270|Procedure|Postop Dressing|The AQUACEL® Ag Surgical Dressing is a silver impregnated, waterproof, adhesive dressing that sticks to the skin around the wound and blocks bacteria from the outside.
16217457|NCT01258270|Procedure|Postop Dressing|A standard island dressing consists of adhesive tape and gauze.
16217458|NCT01258257|Procedure|Insertion of a lumbar drain|In patients in the LD group, after insertion of the drain CSF is drained slowly and steadily at a rate of approximately 5 ml per hour. This leads to a planned daily CSF drainage of about 120 ml per day via lumbar route. To facilitate accuracy of drainage, regular drainage control every other hour and stopping in case of unwarranted excess drainage is strongly recommended by the principal investigators. In case of neurological decline suspiciously related to the lumbar drainage, the drain is closed immediately and may be gradually restarted after 12 to 24 hours, after performing a CCT scan. The drain is planned to remain in place until the control angiography on day 7 to 10 after the initial hemorrhage.
16217459|NCT01258244|Other|Audiovisual Feedback|EMTs will get audiovisual feedback on CPR technique during CPR
16217460|NCT01258218|Device|Implantation of an Accent MRI device|Implantation of an Accent MRI device
16217461|NCT01258205|Drug|AMG 139|Four dose levels of AMG 139 administered as multiple doses IV or SC in healthy volunteers (Part A) and subjects with moderate-severe Crohn's disease (Part B).
16217462|NCT01258192|Drug|albumin-bound paclitaxel plus cisplatin|neo-chemotherapy program:Albumin-bound paclitaxel:100 mg/m2, IV (in the vein) on days 1,8 of each 21 day cycle. Cisplatin 75mg/m2,IV DRIP on day 1 of each 21 day cycle.Number of Cycles: 2 cycles before operation.If it is effective ,2 cycles will be given in 6 weeks after radical resection.
16217463|NCT01258179|Other|Analysis of PSP and PAP from venous blood samples|to analyse the peri-operative expression of pancreatic stone protein in surgical patients following major abdominal surgery
16217464|NCT01258166|Procedure|Surgery or immobilization|
16217465|NCT01258153|Drug|Nepadutant oral solution|Oral administration once daily for 7 days
16217466|NCT01258153|Drug|Nepadutant oral solution|Oral administration once daily for 7 days
16217467|NCT01258153|Drug|Placebo matching Nepadutant oral solution|Oral administration once daily for 7 days
16217468|NCT01258140|Radiation|Computed tomography pulmonary angiography|CT pulmonary angiography using iodinated contrast agent
16217469|NCT01258140|Radiation|Computed tomography pulmonary angiography|CT pulmonary angiography using iodinated contrast agent
16217470|NCT01258114|Other|SPA treatment (ST)|"Drug: spa treatment soon after randomization :
~Spa treatment of 18 days. Spa treatment : the most adapted to the concerned pathology and common to all of spa resorts (mineral water drinking, bath with automatic air (bubble bathing), mud body wrapping, manual massages, water exercises ;
~nutritional counseling (french nutritional recommendations booklet) ;
~caloric restriction and physical training on demand (non mandatory)."
16217471|NCT01258114|Other|Non SPA treatment (NST)|"Drug: General practitioner (GP) counselling After randomisation Verbal and/or written advice based on the French national guidelines for a healthy life style brochure (given to the patient by the GP at baseline)"
16217472|NCT01258101|Drug|peginterferon alfa-2a [Pegasys]|180 mcg sc weekly, 24 weeks
16217473|NCT01258101|Drug|peginterferon alfa-2a [Pegasys]|180 mcg sc weekly, 16 weeks
16217474|NCT01258101|Drug|ribavirin|800 mg orally daily
16217475|NCT01258101|Drug|ribavirin|400 mg orally daily
16217476|NCT01258088|Drug|AN2728 Ointment|5mg/cm2, BID
16217477|NCT01258088|Drug|AN2728 Vehicle|5mg/cm2 BID
16217697|NCT01256398|Drug|Vincristine Sulfate|Given IV
16217480|NCT01258062|Drug|GelVac™ nasal powder H5N1 influenza vaccine.|subjects will be randomized to either 30 µg of Inactivated H5N1 Influenza Vaccine Administered in GelVac™ Nasal Powder given as two doses of 15 μg in one nostril or placebo vaccine given as two doses administered in GelVac™ Nasal Powder in one nostril
16217481|NCT01258062|Drug|Placebo|subjects will be randomized to either 30 µg of Inactivated H5N1 Influenza Vaccine Administered in GelVac™ Nasal Powder given as two doses of 15 μg in one nostril or placebo vaccine given as two doses administered in GelVac™ Nasal Powder in one nostril
16217482|NCT01258049|Drug|Artemether Sublingual Spray|Artemether sublingual spray administered at 3 mg/kg (milligrams per kilogram) at specified timepoints
16217483|NCT01258049|Drug|Quinine|Quinine administered intravenously, 20 mg/kg loading dose followed by 10 mg/kg every eight hours
16217484|NCT01258036|Radiation|HRpQCT|High Resolution peripheral Quantitative Computerized tomography
16217485|NCT01258036|Biological|Sampling|Urine and blood samples
16217486|NCT01258036|Radiation|Bone absorptiometry|DXA at the lumbar spine, hip, radius and whole body
16217487|NCT01258023|Biological|Fluad 1x|"15 µg antigen/strain:
~A/California/07/2009 (H1N1) - like strain
~A/Perth/16/2009 (H3N2) - like strain
~B/Brisbane/60/2008- like strain MF59 adjuvant 9.75µg ai 0.5ml"
16217488|NCT01258010|Drug|Tranexamic Acid|Bolus dose of 30 mg/kg of tranexamic acid followed by a continuous intravenous infusion of 16 mg/kg/h of tranexamic acid administered up to 6 hours after surgery.
16217489|NCT01258010|Drug|Placebo|Bolus dose of normal saline (NaCl 0.9%) of equivalent volume followed by a continuous intravenous infusion of NaCl 0.9% administered up to 6 hours after surgery.
16217490|NCT01257997|Biological|15N-Thymidine, 2H-Water|"Stable isotope 15N-thymidine, infused IV (15mg/hour) for 72 hours (phase 1 pilot).
~Stable isotope 2H-water, ingested by mouth once per day for 3 days (phase 1 pilot) or 28 days (phase 2 pilot)."
16217491|NCT01257984|Drug|BAY86-5300|0.02 mg EE as ß-CDC / 3 mg DRSP in a tablet form (1 tablet/day) for up to 120 days, followed by a 4-day tablet-free interval, administered with a dispenser supported by a reminder function
16217492|NCT01257984|Drug|BAY86-5300|0.02 mg EE as ß-CDC / 3 mg DRSP in a tablet form (1 tablet/day) for up to 120 days, followed by a 4-day tablet-free interval, administered with a dispenser without reminder support
16217493|NCT01257958|Drug|19 nor vitamin d|
16217494|NCT01257945|Behavioral|Aerobic Exercise|
16217495|NCT01257945|Behavioral|Flexibility and Function exercise program|
16217496|NCT01257945|Behavioral|Home exercise program|
16217497|NCT01257932|Device|Diffuse Optical Spectroscopy Imaging|Diffuse Optical Spectroscopy Imaging Breast Cancer Response to Neoadjuvant Chemotherapy
16217498|NCT01257919|Drug|Azelaic Acid Foam|Dermal application of Azelaic Acid Foam
16217499|NCT01257919|Drug|Azelaic Acid Gel|Dermal application of Azelaic Acid Gel
16217500|NCT01257906|Drug|CLIND PHOSPHATE (1.2%) AND TRETINOIN (0.025%) TOPICAL GEL|Topical Gel applied in the evening for 84 days
16217501|NCT01257906|Drug|ZIANA®|Topical Gel applied in the evening for 84 days
16217502|NCT01257906|Drug|Vehicle Control|Topical Gel applied in the evening for 84 days.
16217503|NCT01257893|Drug|Aspirin (acetylsalicylic acid)|Aspirin one 81 mg capsule per day for 10-14 consecutive days
16217504|NCT01257893|Drug|Placebo|1 placebo capsule identical in appearance and excipient to aspirin capsule per day for 10-14 consecutive days
16217505|NCT01257867|Dietary Supplement|Lithia water|Oral intake of approximately 2 litres (2L) daily for 4 weeks
16217506|NCT01257867|Dietary Supplement|Natural spring water with negligible lithium levels|Oral intake of approximately 2 litres (2L) daily for 4 weeks
16217507|NCT01257841|Drug|Leptin administration|Leptin 0.05 mg/kg sc daily in divided doses (0800, 1400, 2000, and 0200h) for four days.
16217508|NCT01257841|Behavioral|Fasting|Complete fasting, save for water and multivitamin, for four days.
16217509|NCT01257828|Drug|riluzole|50mg BID orally for 14 days prior to surgery and 28 days after the surgery
16217510|NCT01257828|Drug|Placebo medication|50mg BID orally for 14 days prior to surgery and 28 days after the surgery
16217511|NCT01257815|Drug|Ranibizumab|
16217512|NCT01257802|Drug|depot leuprolide acetate 3.75 mg|Monthly depot leuprolide acetate 3.75 mg vs placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
16217513|NCT01257802|Drug|Placebo|Monthly placebo during cyclophosphamide administration. First dose of study drug given at least 10 days before following dose of cyclophosphamide if cyclophosphamide is given in biweekly or monthly boluses
16217514|NCT01257789|Procedure|laparoscopic gastric bypass|laparoscopic gastric bypass
16217515|NCT01257776|Drug|Autologous adipose derived mesenchymal stem cells|Intra-arterial administration through a selective cannulation of target common femoral artery
16217516|NCT01257763|Device|Transdermal Microchannel Skin System|A member of the research staff will apply the study device to the subject's lateral forehead, temple and nasolabial area on randomly selected sides of the face, 3 times at each anatomical location, for a total of 9 applications. All subjects will also receive 9 adjacent applications to the central forehead, and they will self-administer 3 adjacent applications to the chin under instruction of study staff.
16217517|NCT01257763|Device|Sham device|The side not receiving application of the study device at each anatomical location will receive a comparable number of applications of a sham device.
16217518|NCT01257750|Drug|Pazopanib (5mg/ml)|Topical pazopanib, 4 times per day for 3 weeks
16217519|NCT01257737|Drug|HPN-100|Participants received individualized doses of HPN-100 orally, three times daily (TID) with meals. The initial dose was the same dose administered at the end of the HPN-100-005SE, HPN-100-007, or HPN-100-012SE studies. Dose adjustments (including frequency adjustments) were permitted as judged clinically appropriate by the investigator based on assessment of ammonia-scavenging needs (e.g., severity of the UCD defect, dietary protein intake, and urinary phenylacetylglutamine [PAGN] excretion). The maximum recommended dose of HPN-100 in participants weighing less than 20 kg was 0.53 mL/kg/day (equivalent to 600 mg/kg/day of NaPBA), and was 11.48 mL/m²/day in heavier subjects (equivalent to 13g/m²/day of NaPBA). The maximum HPN-100 dose recommended per protocol was 17.4 mL/day, which is equivalent to 20 g/day of NaPBA.
16217698|NCT01256385|Biological|Cetuximab|Given IV
16217699|NCT01256385|Other|Laboratory Biomarker Analysis|Correlative studies
16217520|NCT01257724|Other|SHARE (Synthesized HIV/AIDS Research Evidence)|"SHARE (Synthesized HIV/AIDS Research Evidence) consists of several components:
~an online searchable database of HIV-relevant systematic reviews;
~monthly email updates highlighting new reviews;
~access to user-friendly summaries produced by us or by others (when available);
~links to scientific abstracts;
~peer relevance assessments, which involves periodic requests to complete a brief assessment of how useful the information in the newly added review is with the average score posted once an assessment is completed;
~an interface for participants to leave comments in the records of systematic reviews in the database;
~links to full-text articles (when publicly available); and
~access to worksheets that help CBOs find and use research evidence"
16217521|NCT01257711|Procedure|Roux-en-Y or Billroth II|Roux-en-Y had fewer problems related to reflux of bile but a higher incidence of stasis in the Roux limb resulting in longer hospital stay. Some surgeon avoids doing Roux-en-Y is a triad of post operative symptoms including abdominal pain, vomiting and nausea called Roux-en-Y loop syndrome. Billroth II reconstruction is a simpler operation with only one anastomosis and faster operating time. This has implications while managing gastric cancer patients who may be malnourished and a simpler procedure may have lesser risk of complications and yield better outcomes. Billroth II has increased reflux associated problem like esophagitis and gastritis, risk of afferent loop and dumping syndrome. Long term nutritional outcomes are similar for both procedures.
16217522|NCT01257698|Drug|Dorzolamide 2%-timolol 0.5% topical eyedrops|Dorzolamide 2%-timolol 0.5%, 1 drop in operated eye twice daily until gas bubble completely resorbed. Patients randomized to this arm are instructed to use this drop in addition to standard post-operative eye drops.
16217523|NCT01257672|Drug|Ondansetron|ondansetron syrup (0,15 mg/Kg of body weight)
16217524|NCT01257672|Drug|Domperidone|domperidone syrup (0,5 mg/Kg of body weight)
16217525|NCT01257672|Drug|placebo|placebo
16217526|NCT01257659|Procedure|STARR rectocele repair|The STARR transanal stapling system is used to repair a rectocele.
16217527|NCT01257659|Procedure|Elevate mesh rectocele repair|A posterior Elevate mesh is placed transvaginally to repair a rectocele.
16217528|NCT01257646|Other|Gait analysis|A Gaitrite system, a goniometer, and EMG are used to record data while the patient walks 10 meters.
16217529|NCT01257633|Procedure|Transoral robot-assisted tumor resection using the da Vinci robot|Transoral robot-assisted tumor resection using the da Vinci robot
16217530|NCT01257620|Dietary Supplement|Probiotic|Bifidobacterium infantis, 2 capsules (2.0E+9 CFU/capsule) 3 times/day for a total of 1.2E+10 CFU/day for 21 days.
16217531|NCT01257607|Drug|MIM-D3 Ophthalmic Solution|28 Days, BID
16217532|NCT01257607|Drug|Placebo Ophthalmic Solution|28 Days, BID
16217533|NCT01257594|Drug|erlotinib|"For patients with no cytoreductive surgery planned, patients will receive single-agent erlotinib at a starting dose of 2000 mg on days 1 of every 7 days. For patients with cytoreductive surgery planned, patients will receive single-agent erlotinib at a starting dose of 2000 mg day 1 of every 7 days (+/- 2 days). One pre-operative dose of 2000 mg erlotinib will be administered in an open-label, unblinded manner, administered in the hospital on call to the operating room."
16217534|NCT01257594|Procedure|Cytoreductive Surgery|Standard procedure
16217535|NCT01257581|Drug|creatine|creatine monohydrate powder
16217536|NCT01257581|Drug|tamoxifen|Tamoxifen citrate capsules
16217537|NCT01257568|Device|Rejuvenate Modular Hip|Rejuvenate Modular Hip
16217538|NCT01257555|Device|Photopneumatic therapy|Use of intense pulsed light (photo) in combination with vacuum technology (pneumatic) to treat mild to moderate acne.
16217539|NCT01257542|Drug|Dextromethorphan|A single 10 mL dose of Children's Triaminic Syrup (Dextromethorphan Hydrobromide 7.5 mg per 5 mL (total dose of 15 mg)
16217540|NCT01257542|Drug|Placebo|A single 10 mL dose of matching placebo syrup
16217541|NCT01257529|Drug|Pregabalin controlled release, 330 mg, low-fat|A single oral dose of 330 mg controlled release tablet administered following a low-fat evening meal
16217542|NCT01257529|Drug|Pregabalin controlled release, 330 mg, medium-fat|A single oral dose of 330 mg controlled release tablet administered following a medium-fat evening meal
16217543|NCT01257529|Drug|Pregabalin controlled release, 330 mg, high-fat|A single oral dose of 330 mg controlled release tablet administered following a high-fat evening meal
16217544|NCT01257529|Drug|Pregabalin immediate release, 300 mg|A single oral dose of 300 mg immediate release capsule administered following a medium-fat evening meal
16217545|NCT01257516|Drug|Pregabalin immediate release, 300 mg|300 mg immediate release capsule administered twice daily for four days
16217546|NCT01257516|Drug|Pregabalin controlled release, 330 mg|Two tablets of 330 mg (total dose of 660 mg) given concurrently once daily for four days
16217547|NCT01257503|Drug|Hyland's Cold 'n Cough 4 kids|5 ml PO q4h prn cold symptoms
16217548|NCT01257503|Drug|placebo|liquid made to look like the active homeopathic remedy
16217549|NCT01257490|Behavioral|counseling vs. advice|1 session of brief physician advice to quit smoking plus bupropion (12 weeks) compared to 4 sessions of intensive counseling plus bupropion (12 weeks)
16217550|NCT01257464|Drug|Sitagliptin|100mg po one dose
16217551|NCT01257464|Drug|Placebo|Sugar pill po one dose
16217552|NCT01257451|Drug|Vildagliptin|vildagliptin 50mg bid
16217553|NCT01257451|Drug|Placebo|Placebo 50mg bid
16217554|NCT01257438|Device|Fluency Plus Endovascular Stent Graft|Treatment of in-stent restenosis
16217555|NCT01257438|Device|Percutaneous Transluminal Angioplasty only|Treatment of in-stent restenosis
16217556|NCT01257425|Drug|Triptorelin Pamoate (Pamorelin® LA 11.25 mg)|"Pamorelin® LA 11.25 mg administered as standard IM injection (= reference group) at Day 1 and Day 85.
~Triptorelin Pamoate (Pamorelin® LA 11.25 mg) applied subcutaneously (s.c.) at Day 1 and Day 85."
16217557|NCT01257412|Drug|Dapagliflozin|5mg Oral dose od
16217558|NCT01257412|Drug|Dapagliflozin|10 mg Oral dose od
16217559|NCT01257412|Drug|placebo|5/10 mg Oral dose od
16217560|NCT01257399|Drug|Asacol®|400 mg tablets
16217561|NCT01257399|Drug|Mesalazine|400mg tablets
16217562|NCT01257386|Drug|Asacol®|400mg tablets
16217563|NCT01257386|Drug|Mesalazine|400mg tablets
16217700|NCT01256385|Drug|Temsirolimus|Given IV
16217701|NCT01256372|Drug|AP214|AP214
16217702|NCT01256372|Drug|Placebo|Placebo; intravenous infusion
16218457|NCT01250470|Biological|Sargramostim|Given SC
16217564|NCT01257373|Device|Firebird 2 Cobalt-Chromium Alloyed Sirolimus-Eluting Stent|Firebird2 CoCr-alloyed sirolimus-eluting stent system is the 2nd generation of drug-eluting stent(DES). It was registered successfully on Jan. 16, 2009 in China. This stent is based with a CoCr alloyed metal platform. The length is from 13-33mm, the diameter is from 2.5mm-4.0mm.
16217565|NCT01257360|Drug|Panitumumab|Panitumumab 6 mg/kg BW will be administered IV every 2 weeks (q2w) on day -14, 1, 15, 29 (and 43, in case radiotherapy is still ongoing due to delays) of the radiotherapy.
16217566|NCT01257360|Radiation|Radiation of the pelvis|Radiation is applied at single doses of 1.8 Gy at the ICRU 50 reference point, once daily, five times a week, adding up to 28 fractions over almost 6 weeks and a total reference dose of 50.4 Gy.
16217567|NCT01257347|Behavioral|Disclosure of adherence report to clinician|During clinical visits with patients with uncontrolled hypertension, clinicians will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings. Clinicians in the intervention arm will get a brief training (<10 minutes) in the interpretation and use of the report at the time of enrollment.
16217568|NCT01257347|Device|MedSignals pillbox|(Non-experimental) Patients will be given an electronic pillbox. The device records the date and time when each compartment is opened. Adherence to each BP medication was calculated as the percent of doses taken as prescribed. Patients are informed that their adherence was recorded by the electronic pillbox and might be shared with their clinician depending on randomization.
16217569|NCT01257334|Drug|BI 10773|patients with type 2 diabetes mellitus with insufficient glycaemic control despite treatment with metformin alone or metformin in combination with a sulfonylurea
16217570|NCT01257295|Dietary Supplement|control: no fiber addition|liquid breakfast without addition of fiber
16217571|NCT01257295|Dietary Supplement|breakfast with low viscous, low gelling pectin|10g of low viscous, low gelling pectin dissolved in a liquid breakfast
16217572|NCT01257295|Dietary Supplement|high viscous, low gelling pectin|10g of high viscous, low gelling pectin dissolved in a liquid breakfast
16217573|NCT01257295|Dietary Supplement|low viscous, high gelling pectin|10g of low viscous, high gelling pectin dissolved in a liquid breakfast
16217574|NCT01257295|Dietary Supplement|high viscous, high gelling pectin|10g of high viscous, high gelling pectin dissolved in a liquid breakfast
16217575|NCT01257295|Dietary Supplement|pectin supplement|10g of high viscous, high gelling pectin provided as a dietary supplement, a liquid breakfast is served seperately
16217576|NCT01257269|Other|Observation|No interventions planned: treatment of patients at the discretion of the treating/responsible physician
16217577|NCT01257243|Drug|Syrup of oxomemazine, guaifenesin and potassium iodate|5ml each 4 hours
16217578|NCT01257243|Drug|Syrup of guaifenesin|5ml each 4 hours
16217579|NCT01257230|Drug|tiotropium Respimat low dose|IMP
16217580|NCT01257230|Drug|placebo Respimat|placebo representing comparator
16217581|NCT01257230|Drug|tiotropium Respimat high dose|IMP
16217582|NCT01257217|Device|AcrySof® IQ ReSTOR® +3.0 D Multifocal IOL Model SN6AD1|Multifocal IOL implanted for long-term use over the lifetime of the cataract patient
16217583|NCT01257217|Device|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL Model SND1TT|Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
16217584|NCT01257217|Device|Acri.LISA® 366D IOL|Aspheric diffractive IOL with +3.75 D add power implanted for long-term use over the lifetime of the cataract patient
16217585|NCT01257217|Device|Acri.LISA® 466TD Toric IOL|Aspheric diffractive IOL with +3.75 D add power and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
16217586|NCT01257204|Drug|Placebo|Tablets, oral, 0 mg, once daily, for 24 weeks
16217587|NCT01257204|Drug|Daclatasvir|Tablets, oral, 60 mg, once daily, for 12, 16, or 24 weeks
16217588|NCT01257204|Drug|Pegylated interferon alfa-2a|Solution for injection, subcutaneous injection, 180 µg/0.5 mL, once weekly, for 12, 16, or 24 weeks
16217589|NCT01257204|Drug|Ribavirin|Tablets, oral, 800 mg, twice daily, for 12, 16, or 24 weeks
16217590|NCT01257191|Drug|Carbon Black|source: commercial
16217591|NCT01257191|Drug|Diesel Exhaust Particles|source: diesel engine
16217592|NCT01257191|Drug|Fine Concentrated Ambient Particles|source: concentrated ambient air
16217593|NCT01257191|Drug|Ultrafine Concentrated Ambient Particles|source: concentrated ambient air
16217594|NCT01257191|Drug|Saline|Saline solution
16217595|NCT01257178|Drug|LY2624803|Administered orally
16217596|NCT01257165|Drug|Zopiclone|Zopiclone pill 5 or 10 mg, given orally as a single dose.
16217597|NCT01257165|Drug|Ethanol|50 mg per 70 kg body weight, given orally as a single dose
16217598|NCT01257165|Drug|Placebo pill|Placebo pill identical to zopiclone pill, given orally as a single dose
16217599|NCT01257165|Drug|Placebo drink|Placebo drink, given orally as a single dose
16217600|NCT01257139|Procedure|Dual-agent therapy or docetaxel alone or best supportive care|"ARM B: (245 patients)
~Treatment if the SGS screening test is negative:
~non epidermoid tumor:
~Carboplatin ® AUC 5 on D1 and Alimta ®(pemetrexed) 500 mg/m² D1, D1=D21 with vitamin B9 and B12 supplementation. Maximum of four 3-week cycles.
~epidermoid tumor:
~Carboplatin AUC 5 on D1 and Gemcitabin 1000 mg/m² on D1 and D8, D1=D21. Treatment if SGS screening test is positive (cf.table 1): Vulnerable subjects will receive: Taxotere ® (Docetaxel) 38 mg/m² on D1 and D8, D1=D21. Maximum of four 3-week cycles Fragile subjects are patients considered to be at a high risk of complications during chemotherapy; they will therefore receive best supportive care (BSC) with appropriate geriatric management."
16217601|NCT01257126|Drug|diclofenac potassium|
16217602|NCT01257126|Drug|nimesulide|
16217603|NCT01257113|Other|supervised exercise|This group will receive 10 classes of supervised exercise in the 6 weeks intervention. In this classes the patients will be with a physiotherapist that will adjust their home-exercise program and make sure they do the exercises in a good way. They will receive 4-6 exercises they shall do 3 times with 30 repetitions, 2 times every day. If necessary, they should also do stretching exercises
16217604|NCT01257113|Other|homebased exercises|This group will receive 1 class of supervised exercise at the beginning of the 6 weeks intervention. In this class the patients will be with a physiotherapist that will put together a home-exercise program and make sure they do the exercises in a good way. They will receive 4-6 exercises they shall do 3 times with 30 repetitions, 2 times every day. If necessary, they should also do stretching exercises
16217605|NCT01257087|Drug|Insulin|All patients will be prescribed insulin glargine once a day. The dose of the insulin will be adjusted to achieve fasting capillary glucose levels between 5-7 in the intensive group and 7-9 mmol/l in the control group.
16217606|NCT01257074|Drug|Acyclovir 50mg/g|Cream, dose 5 times daily during 5 days
16217607|NCT01257074|Drug|Penciclovir 10mg/g|Cream, dose 5 times daily during 5 days
16217608|NCT01257061|Drug|Group 1|Clemastine fumarate 1,0 mg/g + dexamethasone 0,5/g applied 2 times / day at lesion
16217609|NCT01257061|Drug|Group 2|Dexchlorpheniramine maleate 10 mg/g applied 2 times / day at lesion
16217610|NCT01257048|Drug|Formoterol Turbuhaler|9 microgram on visit 5 single dose
16217611|NCT01257048|Drug|Budesonide/Formoterol Turbuhaler|320/9 microgram twice daily during 8 weeks
16217612|NCT01257048|Drug|Formoterol Turbuhaler|9 microgram twice daily during 8 weeks
16217613|NCT01257035|Other|18F-FAZA-PET/CT|Contrast fluid injected prior to scan
16217614|NCT01257022|Behavioral|Familias Unidas|There will be 8 group sessions and 4 family visits. During the group sessions, the facilitator offers support for parents and gently corrects maladaptive interactions between parents and adolescents. During family visits, facilitators assist families in practicing skills and restructuring family interactions. The parent group sessions focus on parental investment in the adolescent's worlds (e.g., peer and school worlds), family communication, family support, behavior management/positive parenting, parental monitoring, adolescent substance use, and adolescent unsafe sex and HIV.
16217615|NCT01257009|Drug|Atorvastatin|6 weeks treatment with atorvastatin and studying the effect of atorvastatin on sympathetic activity
16217616|NCT01256996|Procedure|Air abrasion of the implant surface with a low abrasive powder|Test treatment will be performed using the low abrasive powder in a standard air-polishing unit, which will be set up according to the manufacturer's instructions. The unit will be set to a medium water and powder setting, and the powder chamber will be filled to the indicated maximum powder level before treatment to ensure reproducible treatment conditions. The jet will be directed to the periodontal pocket for 5 s per surface (vestibular, lingual, mesio and distal) for subgingival plaque removal.
16217617|NCT01256983|Behavioral|Bright Light Therapy|10000 Lux for 30 Minutes according to sleep wake rhythm
16217618|NCT01256983|Behavioral|Wait-list intervention|10000 Lux for 30 Minutes according to sleep wake rhythm
16217619|NCT01256957|Device|HEPA filter|
16217620|NCT01256905|Drug|Armodafinil|Armodafinil 150 mg
16217621|NCT01256892|Procedure|induction of labour|
16217622|NCT01256879|Drug|Drug: cimetidine|cimetidine 200mg total dose (single dose) as either CimTest-A capsules, CimTest-B capsules, sorbitol-free solution, or commercial cimetidine solution
16217623|NCT01256866|Drug|Dexmedetomidine|
16217624|NCT01256866|Drug|Midazolam|
16217625|NCT01256853|Drug|MVA Vaccine|The starting dose will be 5 x 107 plaque forming units (pfu) given by intradermal vaccination. Cohorts of three patients will receive escalating doses of the vaccine (100%, 100%, 67% and 50%). The dose escalation scheme is 5 x 107 pfu, 1 x 108 pfu, 2 x 108 pfu, 3.3 x 108 pfu, 5 x 108pfu. This will be dependant on toxicity.
16217626|NCT01256814|Behavioral|SystemCHANGE-HIV|SystemCHANGE, is based on social ecological theory and focuses on redesigning the family environment and daily routines that are linked to health behavior. This framework emphasizes context and specifies that change is best accomplished by: identifying a measurable goal, examining the system processes surrounding attainment of that goal, listing several ideas that may improve the system, engaging in a series of experiments to test the best ideas to improve the process, implementing the most successful ideas based on data from the experiments, and monitoring the system to maintain the gains. The SystemCHANGE-HIV intervention works to help participants make small environmental changes made in family daily routines that will eventually construct an environment.
16217627|NCT01256801|Biological|cytokine|interleukin 2 2 million unit every week
16217628|NCT01256788|Device|Euflexxa|4 injections of 2ml of Euflexxa
16217629|NCT01256788|Other|Saline|4 injections of 3 ml of sterile saline
16217630|NCT01256775|Drug|NCX-4016|NCX4016 800 mg b.i.d. for 6 months on top of aspirin 100 mg o.d.
16217631|NCT01256775|Drug|NCX4016 placebo|NCX4016 placebo b.i.d. for 6 months
16217632|NCT01256762|Drug|Imetelstat sodium|Imetelstat is administered at a dose of 300 mg/m2 on day one of a 21 day cycle.
16217633|NCT01256762|Drug|Bevacizumab|Bevacizumab is administered at 15 mg/kg on day one of a 21 day cycle
16217634|NCT01256762|Drug|Paclitaxel|Paclitaxel is administered at 90 mg/m2 on days one and eight of a 21 day cycle
16217635|NCT01256736|Drug|Tocilizumab|intravenously at dose of 8mg/kg over 1 hour infusion every 4weeks
16217636|NCT01256736|Drug|DMARDs|DMARDs(chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide)
16217637|NCT01256710|Device|Implantation of the Trifecta Valve|Implantation of the bioprothesis valve, Trifecta Valve
16217638|NCT01256697|Dietary Supplement|Alga Dunaliella Bardawil|9-cis Rich Powder
16217639|NCT01256697|Dietary Supplement|Alga Dunaliella Bardawill|9-cis Rich Powder
16217640|NCT01256697|Other|Sugar pill|Sugar pill
16217641|NCT01256684|Drug|Placebo|Placebo vaginal suppository
16217642|NCT01256684|Drug|DHEA|Vaginal suppository containing 0.25% (3.25 mg) DHEA; daily dosing with one suppository for 12 weeks.
16217643|NCT01256684|Drug|DHEA|Vaginal suppository containing 0.50% (6.5 mg) DHEA; daily dosing with one suppository for 12 weeks.
16217644|NCT01256671|Drug|DHEA|Vaginal suppository containing 0.5% (6.5 mg) DHEA; daily dosing with one suppository for 52 weeks.
16217645|NCT01256658|Drug|COA566|COA566 tablets or dispersible tablets twice daily during 3 days; dosage according to body weight.
16217646|NCT01256645|Other|blood transfusion|application of single units of red blood cell transfusions
16217647|NCT01256632|Drug|Ranibizumab|All study eyes will receive 0.5mg, of intravitreous monthly injections of ranibizumab, for four initial doses,(Day 0, Month 1, Month 2, and Month 3),with scheduled follow-up visits monthly for 12 months. Re-treatment after.
16217648|NCT01256619|Drug|Marvelon|The study was a clinical trial without any control group. Sixty one healthy women were included in the study. The participants had been referred to family planning clinics centers under the supervision of Tehran University of Medical Science. weight and blood pressure were measured for all participants at baseline, at the end of cycle 1, at end of cycle 2, at the end of cycle 3 and at the end of cycle 6. Blood pressure was measured on the right arm with the subject seated after 10 minutes of rest
16217649|NCT01256593|Drug|Pregabalin (Lyrica) capsule|"Lyrica® Capsules depending on the investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dosage for oral use begins at 150 mg/day of pregabalin in twice daily, and should be gradually increased to 300 mg/day over 1 week or more and should be orally administered twice daily. Dosage should be adjusted, depending on age or symptoms. However, the daily maximum dose should not be beyond 600 mg, and should be orally administered twice daily."
16217650|NCT01256580|Drug|Bevacizumab (Avastin; Genentech, Inc.)|1.25 mg bevacizumab (Avastin; Genentech, Inc.) by intravitreal injection
16217651|NCT01256580|Drug|Bevacizumab, Dexamethasone, Verteporfin Photodynamic Therapy|Intravitreal injection of 1.25 mg bevacizumab (Avastin; Genentech, Inc.) combined with reduced-fluence verteporfin PDT (Visudyne®; Novartis) and 200ug of intravitreal dexamethasone
16217652|NCT01256567|Biological|Ramucirumab|Ramucirumab administered as an intravenous (I.V.) infusion at a dose of 10 milligrams per kilogram (mg/kg) every 3 weeks.
16217653|NCT01256567|Drug|Docetaxel|Docetaxel administered by intravenous (I.V.) infusion at a dose of 75 milligrams per square meter (mg/m^2) every 3 weeks.
16217656|NCT01256541|Drug|Kristalose|The dosing regimen of Kristalose will be nine 20-gram doses (one dose every 30 minutes for 4 straight hours) taken the evening before the colonoscopy procedure.
16217657|NCT01256528|Procedure|Delayed Breast Reconstruction|Approximately 3 months after postmastectomy radiation therapy, the preserved, irradiated, and re-inflated breast skin will be used to perform the delayed breast reconstruction. During the stage 2 reconstruction, the implant or expander will be removed and the definitive reconstruction will be performed with the preserved breast skin utilizing a preference for autologous tissue or autologous tissue with an implant due to the potential for complications with implant-based reconstructions after radiation therapy (XRT).
16217658|NCT01256515|Behavioral|Health Education|CDs, techniques, advice, and group training pertaining to a healthier lifestyle. Both groups will have this intervention, but the specific type of health education training will vary between groups.
16217659|NCT01256515|Behavioral|Health Education Training|8 weeks of group training regarding health education techniques.
16217660|NCT01256502|Device|SERI® Surgical Scaffold|Breast reconstruction surgery
16217661|NCT01256489|Drug|Infliximab|The drug will be administered intravenously every month for 110 weeks (duration of the study). The initial dose of infliximab will be 5mg/kg of body weight. The dose may be adjusted up to a maximal dosing of 10mg/kg depending upon disease activity, as judged by the investigators.
16217662|NCT01256476|Drug|pitavastatin|pitavastatin 4 mg once daily (QD)
16217663|NCT01256476|Drug|pravastatin|Pravastatin 40 mg once daily (QD)
16217664|NCT01256463|Behavioral|HIV prevention intervention|
16217665|NCT01256450|Drug|Buprenorphine|buccal soluble film; applied to the buccal mucosa twice daily
16217666|NCT01256450|Drug|Placebo|buccal soluble film; applied to the buccal mucosa twice daily
16217667|NCT01256437|Drug|Threolone ointment|ointment once daily for 1 month
16217668|NCT01256437|Drug|ointment Synthomycine|ointment once daily for 1 month
16217669|NCT01256437|Drug|Aqua cream|ointment once daily for 1 month
16217670|NCT01256424|Drug|HAL 5% with illumination|Treatment with a singe dose of 2g, HAL 5% ointment followed by photoactivation
16217671|NCT01256424|Drug|HAL 1% with illumination|Treatment with a singe dose of 2g, HAL 1% ointment followed by photoactivation
16217672|NCT01256424|Drug|HAL 0.2% with illumination|Treatment with a singe dose of 2g, HAL 0.2% ointment followed by photoactivation
16217673|NCT01256424|Drug|Placebo ointment without illumination|Treatment with a singe dose of 2g placebo ointment, no photoactivation
16217674|NCT01256411|Drug|LCZ696|Participants received LCZ696 200 mg as the starting dose with optional down titration to 100 mg for tolerance and optional up titration to 400 mg for adequate blood pressure control.
16217675|NCT01256411|Drug|Amlodipine|Optional add-on of amlodipine (5-10 mg) was allowed (as applicable per local country regulations) for adequate blood pressure control.
16217676|NCT01256411|Drug|Hydrochlorothiazide (HCTZ)|Optional add-on of hydrochlorothiazide (HCTZ) (12.5-25 mg) was allowed (as applicable per local country regulations) for adequate blood pressure control.
16217677|NCT01256398|Biological|Alemtuzumab|Given IV
16217678|NCT01256398|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo peripheral blood allogeneic HCT
16217679|NCT01256398|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo peripheral blood autologous HCT
16217680|NCT01256398|Drug|Cyclophosphamide|Given IV
16217681|NCT01256398|Drug|Cytarabine|Given IV
16217682|NCT01256398|Drug|Dasatinib|Given PO
16217683|NCT01256398|Drug|Daunorubicin Hydrochloride|Given IV
16217684|NCT01256398|Drug|Dexamethasone|Given PO or IV
16217685|NCT01256398|Drug|Etoposide Phosphate|Given IV
16217686|NCT01256398|Biological|Filgrastim|Given SC
16217687|NCT01256398|Drug|Fludarabine Phosphate|Given IV
16217688|NCT01256398|Procedure|In Vitro-Treated Peripheral Blood Stem Cell Transplantation|Undergo peripheral blood autologous or allogeneic HCT
16217689|NCT01256398|Other|Laboratory Biomarker Analysis|Correlative studies
16217690|NCT01256398|Drug|Leucovorin Calcium|Given IV or PO
16217691|NCT01256398|Drug|Melphalan|Given IV
16217692|NCT01256398|Drug|Mercaptopurine|Given PO
16217693|NCT01256398|Drug|Methotrexate|Given IT, IV, or PO
16217694|NCT01256398|Biological|Pegfilgrastim|Given SC
16217695|NCT01256398|Other|Pharmacological Study|Correlative studies
16217696|NCT01256398|Drug|Tacrolimus|Given IV or PO
16217703|NCT01256359|Drug|Docetaxel and AZD6244|Docetaxel 75mg/m2 IV and AZD6244 75mg bd daily. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but AZD6244 may be continued beyond this, until disease progression.
16217704|NCT01256359|Drug|Docetaxel and placebo|Docetaxel 75mg/m2 IV and placebo given bd. Docetaxel will be administered every 3 weeks for a maximum 6 cycles, but placebo may be continued beyond this, until disease progression.
16217705|NCT01256346|Device|Apparatuses|Each baby will have both pulse oximetry leads (Massimo Radical 7) and electrocardiography leads (3M™ Red Dot™ Neonatal Limb Band Monitoring Electrodes, Pre-wired) applied. The time required for each modality to register a heart rate will be compared.
16217706|NCT01256320|Other|Classic Egg Group|consumption of 6 eggs/week (1 egg/day for 6 days with 1 day rest) of commercial classic eggs
16217707|NCT01256320|Other|Omega 3 Egg Group|consumption of 6 eggs/week (1 egg/day for 6 days with 1 day rest) of commercial Omega-3 eggs
16217708|NCT01256307|Other|training and educational program|8 weeks
16217709|NCT01256307|Other|educational program|8 weeks
16217710|NCT01256294|Drug|Generic Tacrolimus|Generic Sandoz tacrolimus supplied as capsules of 0.5 mg, 1 mg and 5 mg dose strengths.
16217711|NCT01256294|Drug|Branded Tacrolimus|Capsules supplied at dose strengths of 0.5 mg, 1 mg, and 5 mg.
16217712|NCT01256281|Procedure|Femoral Nerve Block|Patients enrolled will receive ultrasound guided FNB in addition to standard care. If subjects are experiencing pain in both lower extremities, both extremities will be blocked; if subjects are experiencing pain in one lower extremity, only the affected extremity will be blocked.
16217713|NCT01256268|Drug|Ridaforolimus|Phase 1A: Ridaforolimus 20-40 mg will be administered daily for 5 days per week (days 2-5, days 8-12, days 15-19) in the first cycle of therapy and for further cycles on days 1-5, days 8-12, days 15-19 throughout the remainder of therapy. On the day of coadministration of ridaforolimus with paclitaxel 175mg/m^2 IV and carboplatin AUC 5-6mg/ml/min on day 1 of each 3 week cycle, ridaforolimus will be dosed at the time of initiation of paclitaxel infusion. Phase 1B: as outlined in Treatment Arms.
16217714|NCT01256268|Drug|Paclitaxel|Phase 1A: Paclitaxel 175mg/m2 IV. Phase 1B: As outlined in Treatment Arms.
16217715|NCT01256268|Drug|carboplatin|Phase 1A: Carboplatin AUC 5-6mg/ml/min on day 1 of each 3 week cycle. Phase 1B: As outlined in Treatment Arms.
16217716|NCT01256242|Device|Augment Rotator Cuff|rhPDGF-BB and bovine collagen matrix
16217717|NCT01256242|Procedure|Standard Suture Repair|standard suture repair
16217718|NCT01256229|Device|cochlear implantation|This is the experimental therapy for deaf children with developmental delays, and the conventional therapy for deaf children without developmental delays.
16217719|NCT01256229|Device|hearing aids|This is the conventional therapy for deaf children with developmental delays.
16217720|NCT01256216|Device|Total Knee Replacement with Vanguard Total Knee|Patients indicated for a total knee replacement utilizing the Vanguard Total Knee System.
16217721|NCT01256203|Drug|Solar Protection Formula SPF® 60|Solar Protection Formula SPF® 60 (2 mg/cm²) will be topically applied on a randomly predetermined specific skin area on the back of each subject on four separate occasions over 3 months. The same skin area will never be exposed more than once to the sunscreen.
16217722|NCT01256203|Procedure|Photobiological testing|Photobiological testing will consist of exposing a small area of the sunscreen-protected and unprotected (control) skin areas to visible light on four separate occasions over 3 months. Light will be applied 30 minutes after application of the sunscreen. The same skin area will never be exposed more than once to light.
16217723|NCT01256190|Biological|Fibrocaps (fibrin sealant)|human thrombin and fibrinogen topical powder
16217724|NCT01256190|Device|Gelatin sponge|absorbable gelatin sponge for topical use
16217725|NCT01256177|Drug|Quetiapine Fumarate (SEROQUEL) Extended Release|Quetiapine fumarate extended release(XR) will be administered orally, once daily in the evening. The initial dose will be 50 mg. This dose will be adjusted on Day 2 to 100 mg, on Day 3 to 200 mg, and on Day 4 to 300 mg and after.
16217726|NCT01256177|Drug|Placebo|Placebo matching quetiapine extended release(XR) 50 mg, 200 mg, and 300 mg tablets will be orally administered once daily, in the evening. The initial dose will be 50 mg. This dose will be adjusted on Day 2 to 100 mg, on Day 3 to 200 mg, and on Day 4 to 300 mg and after.
16217727|NCT01256164|Device|Fibrocaps (fibrin sealant)|Fibrocaps powder (max dose 1.5g) should be applied directly to the bleeding site or to the Gelfoam and then applied to the bleeding site. Re-application of 1.5 g of Fibrocaps is allowed.
16217728|NCT01256164|Device|Gelfoam|An identified Target Bleeding Site (TBS) should be treated with application of Gelfoam followed by light manual pressure with a sterile gauze.
16217729|NCT01256151|Drug|Alprazolam tablet|1 mg single dose of alprazolam conventional tablet
16217730|NCT01256151|Drug|Alprazolam sublingual|1 mg single dose of alprazolam sublingual tablet
16217731|NCT01256112|Behavioral|Parent Supported Behavioral Intervention|Parents of participants receive training in behavioral support at home in order to facilitate lifestyle change associated with dietary choices and physical activity designed to produce gradual weight loss.
16217732|NCT01256112|Behavioral|Nutrition/Activity Education (NAE)|
16217733|NCT01256099|Behavioral|Therapist guided Internet-CBT for insomnia|An 8 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for insomnia
16217734|NCT01256099|Behavioral|Brief Internet-CBT for insomnia, without support|No support and less text, not including the CBT-methods that are presumed to be most effective to reduce Insomnia symptoms
16217735|NCT01256099|Behavioral|Therapist Guided Internet-CBT for depression|An 9 week long, structured self-help program with weekly reports to, and feedback from, a CBT therapist over the Internet. Includes traditional CBT-methods for depression. Information and methods regarding sleep difficulties removed
16217736|NCT01256086|Drug|Formatris 24µg|12µg Formoterol Novolizer#1 + 12µg Formoterol Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
16217737|NCT01256086|Drug|Formatris 12µg|12µg Formoterol Novolizer#1 + Placebo Novolizer#2 + Placebo Aerolizer#1 + Placebo Aerolizer #2
16217738|NCT01256086|Drug|Foradil P 24µg|Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + 12µg Formoterol Aerolizer #2
16217739|NCT01256086|Drug|Foradil P 12µg|Placebo Novolizer#1 + Placebo Novolizer#2 + 12µg Formoterol Aerolizer#1 + Placebo Aerolizer #2
16217740|NCT01256073|Drug|IPH2101|IPH2101 fully human anti-KIR monoclonal antibody
16217741|NCT01256060|Drug|Intranasal Oxytocin|We are selecting morning and afternoon dosing to try to influence most hours where youth are in settings with increased potential for social interaction (school, after school). Medication will be administered by the parents before school and early afternoon. All patients will receive their first dose by the study physician to educate parents and themselves on proper administration and determine safety of first dose.
16217742|NCT01256047|Dietary Supplement|Oral IMPACT|oral supplement for 5 days(1L/day) before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA
16217743|NCT01256034|Dietary Supplement|Oral IMPACT|oral supplementation for 5 days (1L/day) before surgery of a formula enriched with arginine, omega-3 fatty acids, and RNA
16217744|NCT01256021|Drug|Botulinum Toxin Type A|1 time, gastrocnemius muscles injection, dose of 4U/kg body weight in patients with hemiplegia, dose of 6U/kg body weight in patients with diplegia, Maximum dosage 200U
16217745|NCT01256008|Behavioral|CBT|The subjects will receive standardized CBT treatment regularly for 9 sessions(once per week in the first month and once half a month in the second and third months), and each session will last for about 60 minutes.The treatment includes three steps:Concept stage (the first and second sessions): establishment of therapeutic relationships with the subjects; Skills acquisition and repeat stage (the third session to the 8th session): clarification of sources of stress, patients' cognitive and behavioral response to stress. Application and complete price segment (the 9th session): return visit to test efficacy of psychological intervention.
16217746|NCT01256008|Behavioral|Clinical Management|"Clinical management is a clear contrast method of psychological therapy, which is a half-structured interview and lasting for 20-25 minutes each session. Clinical management will be assigned to both experimental group and controlled group in the first stage of intervention.
~Following are major elements:
~Talk to the subjects to find their main problems; introduce knowledge and medication knowledge about cancer and depression; subjects reporting use of drugs for cancer and depression and a variety of signs and symptoms of the reaction. Encourage patients to adhere to drug treatment and to comply with this research program; The operation of CBT and clinical management should be conducted by the same person as far as possible."
16217747|NCT01255995|Device|Capsular Tension Ring|Capsular Tension Ring
16217748|NCT01255969|Other|Exercise|Personalized exercise program
16217749|NCT01255956|Device|Rapamycin eluting stent implantation|Rapamycin eluting stent implantation for in-stent restenosis treatment
16217750|NCT01255956|Device|Paclitaxel eluting balloon catheter|Paclitaxel eluting balloon catheter for in-stent restenosis treatment
16217751|NCT01255943|Behavioral|healthcare staff processes for infection prevention|Toyota lean and positive deviance discovery and action dialogues to facilitate process improvement
16217752|NCT01255904|Drug|Chloral Hydrate|Oral chloral hydrate 50 mg/kg
16217753|NCT01255904|Drug|Dexmedetomidine|Intranasal dexmedetomidine 3 mcg/kg
16217754|NCT01255904|Other|Oral placebo|Oral saline administered
16217755|NCT01255904|Other|Intranasal placebo|Intranasal saline administered
16217756|NCT01255891|Radiation|Androgen suppression plus radiation therapy|Adjuvant androgen suppression plus radiation therapy
16217757|NCT01255878|Device|occlusal stabilization splint|
16217758|NCT01255878|Drug|Gabapentine|100 mg(1 capsule)three times per day for two months
16217759|NCT01255852|Drug|atorvastatin|Patients in atorvastatin group will received 80 mg atorvastatin daily from 3 days before the index procedure to 12 months after the procedure.
16217760|NCT01255839|Device|Double Balloon|The Double Balloon Catheter was applied (Atad 5) with 80 ml NaCl installed intrauterine above the intern orificium and 80 ml below in cervix/vagina.
16217761|NCT01255839|Drug|Minprostin|The prostaglandin 2 minprostin (3mg) was applied vaginally
16217762|NCT01255826|Procedure|Resuscitation of preterm neonates by sustained lung inflation through T piece device followed by CPAP|After oropharyngeal and nasal suctioning, if there are no signs of spontaneous breathing or breathing is insufficient and/or heart rate is below 100 bpm, the following approach will be followed:Pressure-controlled (20 cm H2O) inflation will be sustained for 15 secs, using a neonatal mask and a T-piece ventilator (NeoPuff Infant Resuscitator; Fisher & Paykel).To avoid pressure leakage, we will use a neonatal mask of appropriate size which adequately cover both the mouth and nostrils of infants. This pressure controlled inflation will be followed by CPAP at 5 Cm H2O.This procedure will be repeated a second time with a pressure of 25 cm H2O for 15 secs if breathing remained insufficient and/or the heart rate is < 100 bpm and/or the infant is cyanotic. To be followed by CPAP at 6 Cm H2O.A third puff with a pressure of 30 cm H2O for 15 secs will be used after few seconds if inadequate heart rate and respiration was not reached. This will be followed by CPAP at 7 Cm H2O.
16217763|NCT01255826|Procedure|Resuscitation of preterm neonates by intermittent bag and mask ventilation using self inflating bag.|After oropharyngeal and nasal suctioning, if there is no signs of spontaneous breathing or breathing is insufficient and/or heart rate is below 100 bpm, intermittent mask and bag ventilation will be administrated at a rate 40-60 per minute using a self-inflating bag and mask with an oxygen reservoir.
16217764|NCT01255813|Device|Stimulation (Sub-perception)|Stimulation applied below the perception threshold
16217765|NCT01255813|Device|Stimulation (Full)|Stimulation applied above the perception threshold
16217766|NCT01255813|Other|Control|No stimulation applied
16217767|NCT01255800|Drug|IPI-926 and Cetuximab|"Patients will receive Cetuximab IV every week.
~Starting on Day 15 of the first cycle, Patients will take IPI-926by mouth every day."
16217768|NCT01255787|Drug|Vortioxetine|Vortioxetine tablets
16217769|NCT01255787|Drug|Placebo|Vortioxetine placebo-matching tablets
16217770|NCT01255774|Drug|ranibizumab|An open-label, study of intravitreally administered ranibizumab
16217771|NCT01255761|Biological|Certolizumab Pegol (CZP)|"400 mg subcutaneous injection at Weeks 0, 2 and 4
~200 mg subcutaneous injection every two weeks, Week 6 through Week 52"
16217772|NCT01255748|Radiation|Proton Therapy, Photon Therapy, SRS, Brachytherapy|Outcomes Tracking
16217773|NCT01255722|Drug|iobitridol|single IV injection
16217774|NCT01255722|Drug|iopromide|Single IV injection
16217775|NCT01255722|Drug|iomeprol|Single IV injection
16217776|NCT01255709|Drug|Arm T1: Primatene Mist HFA|epinephrine inhalation aerosol, 90 mcg/inhalation, 12 inhalations over 6 minutes
16217777|NCT01255709|Drug|Arm T2: Primatene Mist HFA|epinephrine inhalation aerosol, 100 mcg/inhalation, 12 inhalations over 6 minutes
16217778|NCT01255709|Drug|Arm C: Primatene Mist (epinephrine inhalation aerosol, USP)|epinephrine inhalation aerosol, 220 mcg/inhalation, 12 inhalations over 6 minutes
16217779|NCT01255696|Biological|ALV003|
16217780|NCT01255696|Biological|ALV003 placebo|
16217781|NCT01255683|Drug|oral corticosteroid taper|This is an observational study in which patients self-select oral steroid treatment for symptoms of CRS. Drug treatments are NOT assigned in this investigation.
16217782|NCT01255670|Drug|penicillin and metronidazole in peritonsillar abscess|Peroral Penicillin: 1000 000 IU 3 times a day for 10 days Peroral metronidazole: 500 mg 3 times a day for 7 days
16217783|NCT01255657|Drug|ABT-806|ABT-806 will be administered by intravenous infusion.
16217784|NCT01255644|Drug|Valganciclovir|900 mg every 24 hours per os, day 1 through 90
16217785|NCT01255631|Device|PEMF Device|"The PEMF device we will use in this study is FDA approved for adjunctive use in the palliative treatment of post-operative pain and edema in superficial soft tissue (510(k) number: K903675). There are no side effects to use of a PEMF device. In the treatment arm, the PEMF would be automatically delivered for 15 minutes every two hours for one month. The manufacturer (Ivivi Technologies, Inc., Northvale, NJ) has already designed a lightweight, disposable device that can be placed around the patient's arm and taped in place. The patient would keep the device in place for two weeks, when they return for a followup visit and receive a fresh device to wear for an additional two weeks."
16217786|NCT01255631|Device|Sham PEMF Device|Inactive PEMF device, delivers no PMF
16217787|NCT01255618|Device|INVOS 5100|Near-infrared range and has been used in newborn infants since 1985. Fibre-optic bundles or optodes are placed either on opposite sides of the tissue being interrogated (usually a limb or the head of a young baby) to measure transmitted light, or close together to measure reflected light. Light enters through one optode and a fraction of the photons is captured by a second optode and conveyed to the measuring device. NIRS uses a frequency band between 650 nm and 1000 nm and relies on three important phenomena: (1) human tissue is relatively transparent to light in the near-infrared region of the spectrum; (2) pigmented compounds known as chromophores absorb light as it passes through biological tissue; and (3) human tissues contain substances whose absorption spectra at near-infrared wavelengths are well defined and depend on their oxygenation status.
16217788|NCT01255592|Drug|AZD5069|Oral dose bid
16217789|NCT01255592|Drug|Placebo|Oral dose bid
16217790|NCT01255579|Drug|Salmeterol Fluticasone|salmeterol 50 mcg and fluticasone 250 mcg (diskus) b.i.d.
16217791|NCT01255579|Drug|formoterol - beclometasone|formoterol 12 mcg and beclometasone 200 mcg HFA (by MDI) b.i.d.
16217792|NCT01255553|Radiation|Partial Breast Irradiation|Partial breast irradiation will be administered using a 3D conformal external beam RT technique. Two fractions of 38.5 Gy separated by at least 6 hours will be given on 5 treatment days over a period of 5 to 10 days.
16217793|NCT01255527|Drug|Bortezomib|Bortezomib i.v. 0.7, 1.0 and 1.3 mg/m²/day
16217794|NCT01255514|Drug|high dose dexamethsone|high dose dexamethasone : 40mg/day , D1-D4, D9-D12, IV or PO, repeat every 21days for 2cycles
16217795|NCT01255501|Drug|NI-0701|
16217796|NCT01255501|Drug|Placebo|
16217797|NCT01255488|Behavioral|Access to EBN-Search (without full-text manuscripts)|Family nurse practitioner access to EBN-Search without availability of full-text manuscripts.
16217798|NCT01255475|Drug|Hydralazine/amlodipine|Patients will receive drug therapy aimed to reducing blood pressure - first line drug will be hydralazine up to 100mg/day; if systolic blood pressure reduces less than 20% from baseline and remains over 100mmHg patients will further receive amlodipine up to 10mg/day
16217799|NCT01255475|Drug|Placebo|Patients will receive placebo
16217800|NCT01255462|Biological|LFG316|
16217801|NCT01255462|Biological|LFG316|
16217802|NCT01255462|Biological|LFG316|
16217803|NCT01255462|Biological|LFG316|
16217804|NCT01255449|Drug|albuterol|400 mcg by inhalation
16217805|NCT01255436|Other|SMS text reminders|Patients in the intervention arm will receive 2 text messages per week delivered via SMS on randomly chosen days and times during the 12-week study period. The aims of the messages are to remind patients to take their blood pressure medications daily, what the target blood pressure is, and the benefits of daily intake of anti-hypertensive medications.
16217806|NCT01255436|Other|Usual Care|Patients in the usual care arm will receive the care usually provided by their physicians. This consists of consultations, medical advice, and prescriptions for maintenance medications. They will not be sent any SMS text reminders from the study.
16217807|NCT01255423|Drug|Diclofenac sodium topical gel 1%|Diclofenac sodium topical gel 1%, 4 times daily
16217808|NCT01255423|Drug|Placebo|Placebo, 4 times daily
16217809|NCT01255410|Biological|10^6 PFU rHMPV-Pa vaccine|Single dose of 10^6 PFU rHMPV-Pa vaccine delivered intranasally
16217810|NCT01255410|Biological|10^5 PFU rHMPV-Pa vaccine|Single dose of 10^5 PFU rHMPV-Pa vaccine delivered intranasally
16217811|NCT01255410|Biological|Placebo Vaccine|Single dose of placebo vaccine delivered intranasally
16217812|NCT01255397|Procedure|Male Infertility Protocol|"Healthy women with a regular cycle between 28 and 35 days. For the man, an abnormal sperm exam.
~Daily US examinations from day 8 of the menstrual cycle. Excluding weekends.
~When the leading follicle is 14 mm she will be given 100 units puregon and orgalutran,once daily until the leading follicle is at least 16 mm at which point she will be given ovitrelle at 21:00.
~35 hours after Ovitrelle at 8:00 the husband will present a sperm sample for analysis. A pelvic US will be done to the wife.
~If the follicle has collapsed than IUI will be performed
~It the total motile sperm count is above 5 million sperm/ml then IUI will be done
~If the total motile sperm count is below 5 million and the follicle has not collapsed, proceed to oocyte aspiration and ICSI
~6) ICSI and embryo transfer performed on the same day. 7) Luteal support: Endometrin 100 mg twice a day following IUI\ET until 6 weeks gestation Protocol can be repeated for up to 3 cycles per couple."
16217813|NCT01255371|Drug|Lopinavir|Evaluation of second line antiretroviral regimen including boosted lopinavir
16217814|NCT01255371|Drug|Atazanavir|Evaluation of second line antiretroviral regimen including boosted atazanavir
16217815|NCT01255358|Drug|Dexamethasone|dexamethasone encapsulated in human erythrocytes. One infusion per month of about 10-15 mg of dexamethasone. The treatment covers 1 month of therapy-
16217816|NCT01255345|Other|Chronic pelvic pain|A physioterapeutic examination of abnormal muscular findings, i.e tonus, elasticitt and strength, in the pelvic area connected to female CPP.
16217817|NCT01255306|Other|Optical coherence tomography|"Optical coherence tomography will be performed in all study patients following pars plans vitrectomy and silicone oil tamponade. A fellow eye of each patient will serve as a control. Each patient enrolled in a study will receive 4 measurements:
~On 7th postoperative day
~On 30th postoperative day
~On 90th postoperative day
~On 180th postoperative day"
16217818|NCT01255306|Drug|Local medical treatment of raised intraocular pressure|"In patients with raised intraocular pressure following medications will be employed in order to control the intraocular pressure:
~Cosopt (dorzolamide hydrochloride-timolol maleate ophthalmic solution; b.i.d.) Ganfort (Bimatoprost, timolol maleate ophthalmic solution; once daily) Alphagan (Brimonidine ophthalmic solution; b.i.d.) In patients with intraocular pressure less than 27 mmHg Alphagan will be prescribed. In patients with intraocular pressure greater than 27 mmHg either Cosopt, or Ganfort will be prescribed under the discretion of treating physician. If intraocular pressure in patients treated with either Cosopt or Ganfort does not drop under 21 mmHg, Alphagan will be added."
16217819|NCT01255293|Procedure|1000 centistoke silicone oil|Patients who are enrolled in the study and have been identified to have a complex retinal detachment requiring silicone oil tamponade may be randomly assigned to receive 1000 centistoke silicone oil.
16217820|NCT01255293|Procedure|5000 centistoke silicone oil|Patients who are enrolled in the study and have been identified to have a complex retinal detachment requiring silicone oil tamponade may be randomly assigned to receive 5000 centistoke silicone oil
16217821|NCT01255280|Behavioral|Behavioral Activation Therapy and Risk Reduction Counseling (BAT-RR)|This intervention is given to patients in the experimental condition only and is comprised of 10 sessions.
16217822|NCT01255280|Behavioral|Information, Motivation, Behavioral skills change approach to sexual risk reduction|The comparison condition will only receive the two IMB risk reduction sessions.
16217823|NCT01255254|Procedure|Gingival scaling|Oral hygeine instruction and gingival scaling using hand and ultrsonic instruments.
16217824|NCT01255228|Other|Low glycemic index diet|The study expect that long-term low GI diet intervention have beneficial effects on regulate body composition of obese women
16217825|NCT01255215|Drug|Inhaled Nitric Oxide|Form: Gas (inhalational) Dose: 80 ppm Dosing schedule: Continuous Treatment period: Maximum 72 hours (may be discontinued earlier if patient recovers and no longer tolerates face mask)
16217826|NCT01255189|Device|Device: near infrared spectroscopy: INVOS 5100|NIRS device used in this study, the optical field includes a volume of tissue approximately 2 cm deep to the surface probe with a 4-mm source-detector distance, and thus, organ-specific monitoring is feasible in small patients. With informed consent, we applied NIRS probes to the forehead and the lower extremity for cerebral (rSO2C) and peripheric (rSO2P) regional oxygen saturation measurements.
16217827|NCT01255189|Device|invos 5100|near infrared spectroscopy: invos 5100
16217828|NCT01255176|Procedure|Thoracoabdominal rebalancing|In this group the infants received four handlings thoracoabdominal rebalancing, in order: 1) 5min support thoracoabdominal, in which the therapist leaned one hand on the lower chest and upper abdomen of the newborn, with some of its fingers on the ribs, pulling them gently down and keeping them in that position during inspiration, 2) more than 5 minutes of abdominal support, carried by hand in the lower abdomen of the newborn, applying light pressure during inspiration enough to be beaten by the diaphragm of the newborn and not to increase the use of accessory muscles of inspiration, 3) 5min support ileo-costal, by a slight manual pressure of the physiotherapist on the lateral chest and abdomen of the newborn, maintained throughout inspiration and 4) finally ran up 5min ginga thoracic maneuver slight manual pressure on the lower chest of newborns, directing the costal movement during expiration, now an then the other hemithorax.
16217829|NCT01255163|Drug|Exendin-4 SC|Exenatide 5 mcg or 10 mcg SC twice daily
16217830|NCT01255163|Drug|Placebo SC|Placebo SC twice daily
16217831|NCT01255137|Drug|Axitinib|5 mg tab orally twice a day with food every 28 days
16217832|NCT01255085|Dietary Supplement|yellow pea protein|Served in a tomato soup
16217833|NCT01255085|Dietary Supplement|yellow pea fiber|Served in a tomato soup
16217834|NCT01255085|Dietary Supplement|Control Tomato Soup|Served in a tomato soup
16217835|NCT01255072|Procedure|Transcranial Magnetic Stimulation|20 Sham daily sessions:25 trains, 10seconds at 5Hz, train interval of 25 seconds (time off). Target: left dorsolateral prefrontal cortex.
16217836|NCT01255072|Procedure|Repetitive Transcranial Magnetic Stimulation|20 daily sessions: each one with 25 trains of 10seconds at 5Hz, train interval of 25 seconds (time off), pulse intensity corrected based on atrophy degree by a specific correction formule. Target: left dorsolateral prefrontal cortex.
16217837|NCT01255046|Drug|Donepezil,|10mg/tab, 1 tab/day for 72 weeks
16217838|NCT01255046|Drug|STA-1|300mg/tab, 2 tab/tid for 72 weeks
16217839|NCT01255046|Drug|placebo|2 tab/tid for 72 weeks
16217840|NCT01255033|Device|Monitoring of tissular oxygenation|"Equanox: cerebral oxygenation by spectroscopy, near-infrared through forehead and noninvasive devices
~Inspectra: tissular oxygenation by spectroscopy, near-infrared through thenar and noninvasive device"
16217841|NCT01255020|Drug|α-Keto Acid with restricted protein diet|"α-Keto Acid: The daily dose of compound α-Keto Acid is 100mg/kg/d. The total daily dose will be divided into three times a day.
~Restricted Protein Diet: Diet contain protein 1.0g/kg/d"
16217842|NCT01255020|Drug|Placebo plus restricted protein diet|"placebo: The daily dose of placebo is 100mg/kg/d. The total daily dose will be divided into three times a day.
~Diet contain protein 1.0 g/kg/d."
16217843|NCT01255007|Other|MR imaging|Primovist enhanced MRI, Diffusion weighted MRI
16217844|NCT01254994|Drug|entecavir|Patients in the ETV Group were prescribed 0.5 mg entecavir following oral fasting one time per day.
16217845|NCT01254994|Drug|Traditional comprehensive medical treatment|bed rest, sufficient energy and vitamins, reduced glutathione, prostaglandin E1, hepatocyte growth factor (HGF), plasma and albumin, maintenance of water and electrolyte balance, and prevention and treatment of complications, such as infections, hepatic encephalopathy, hemorrhage, hepatorenal syndrome and ascites.
16217846|NCT01254981|Procedure|Percutaneous coronary intervention (PCI)|Implantation of coronary stent
16217847|NCT01254955|Biological|H1N1 vaccine Pandemrix|
16217848|NCT01254942|Other|B4 Clinic|Fracture Follow-Up Clinic plus Exercise Program
16217849|NCT01254942|Other|Usual Care|
16217850|NCT01254929|Device|F-18 PET bone scan|Following the intravenous administration of approximately 10 mCi F-18, subjects will undergo an F-18 PET bone scan.
16217851|NCT01254929|Device|Tc-99m bone scan|Following the intravenous administration of approximately 30mCi Tc-99m MDP, subjects will undergo a traditional bone scan on a gamma camera.
16217852|NCT01254903|Procedure|Stereotactic Radiosurgery (SSRS)|Target dose of 18 or 24 Gy to spine in single session of radiation treatment.
16217853|NCT01254890|Drug|Azacitidine|75 mg/m^2 subcutaneously (SQ) or by vein (IV) daily for 7 days per 28 day cycle.
16217854|NCT01254890|Drug|Sorafenib|Starting dose level 200 mg by mouth two times a day in a 28 day cycle. In Phase II, Sorafenib administered per MTD dose from Phase I. Drug doses separated by approximately 12 hours.
16217855|NCT01254877|Drug|ondansetron|ondansetron 0.2 mg bid, oral preparation, 16 weeks
16217856|NCT01254877|Drug|placebo ondansetron|Matching placebo will be prepared using a colorless strawberry syrup, simple syrup and flat Schweppes tonic water.
16217857|NCT01254877|Drug|Ondansetron|Ondansetron 0.8 mg bid, oral preparation, 16 weeks duration
16217858|NCT01254864|Drug|Abiraterone Acetate|1000 mg by mouth each day of a 28 day cycle.
16217859|NCT01254864|Drug|Prednisone|5 mg by mouth twice daily of a 28 day cycle.
16217860|NCT01254864|Drug|Sunitinib|37.5 mg by mouth daily for two weeks followed by a week of rest in a 28 day cycle.
16217861|NCT01254864|Drug|Dasatinib|100 mg by mouth each day of a 28 day cycle.
16217862|NCT01254851|Behavioral|goal-augmented post-operative care|Patients in the goal-augmented post-operative care group will be given a goal number of steps to take on each post-operative day following in-patient gynecologic surgery.
16217863|NCT01254838|Biological|HLA-A02 restricted HIG2|
16217864|NCT01254825|Procedure|Adductor-Canal-Block, Ropivacain|Ultrasound-guided ACB; 30 mL Ropivacain 7,5 mg/mL. Single dose.
16217865|NCT01254825|Procedure|Adductor Canal Block, Placebo (saline)|Ultrasound-guided Adductor Canal Block; 30 mL Saline. Single dose.
16217866|NCT01254799|Drug|Doxycycline|100 mg Doxycycline capsules twice daily for 5 days
16217867|NCT01254799|Drug|Placebo|Placebo capsules twice daily for 5 days
16217868|NCT01254786|Procedure|Non-dependent lung ventilation|"the dependent lung will be ventilated with conventional ventilation (OLV) a tidal volume of 6 mL/kg (predicted body weight), whereas FiO2, I: E ratio, PEEP, frequency, peak inspiratory pressures, and a flow of fresh gas will be maintained as during two-lung ventilation for 15 min.
~Then the non-dependent lung will be allowed to deflate to a CPAP of 2 cm H2O, which will be connected to the flowmeter of an oxygen cylinder with a flow rate of 5 L/min and FiO2 of 1.0 for 30 min
~Then, the non-dependent lung will be connected to a second identical ventilator, 15 min after OLV, using a FiO2 of 1.0, VT 3 mL/kg (predicted body weight), I: E ratio <0.3 and R.R 60 breaths/min for further 30 min."
16217869|NCT01254786|Procedure|Non-dependent lung ventilation|"the dependent lung will be ventilated with conventional ventilation (OLV) a tidal volume of 6 mL/kg (predicted body weight), whereas FiO2, I: E ratio, PEEP, frequency, peak inspiratory pressures, and a flow of fresh gas will be maintained as during two-lung ventilation for 15 min.
~Then, the non-dependent lung will be connected to a second identical ventilator, 15 min after OLV, using a FiO2 of 1.0, VT 3 mL/kg (predicted body weight), I: E ratio <0.3 and R.R 60 breaths/min for further 30 min.
~Then the non-dependent lung will be allowed to deflate to a CPAP of 2 cm H2O, which will be connected to the flowmeter of an oxygen cylinder with a flow rate of 5 L/min and FiO2 of 1.0 for 30 min"
16217870|NCT01254773|Drug|Experimental Bapineuzumab|Bapineuzumab 2 mg, Bapineuzumab 7 mg, Bapineuzumab 20 mg, Placebo
16217871|NCT01254760|Device|Nelfilcon A multifocal contact lens, investigational|Investigational, soft, multifocal contact lens for daily wear, daily disposable use.
16217872|NCT01254760|Device|Nelfilcon A multifocal contact lens, commercial|Commercially marketed, soft, multifocal contact lens FDA-approved for daily wear, daily disposable use.
16217873|NCT01254747|Device|Delefilcon A contact lens|Investigational silicone hydrogel, single vision contact lens for daily wear, daily disposable use
16217874|NCT01254747|Device|Lotrafilcon B contact lens (O2 OPTIX, AIR OPTIX)|Commercially marketed silicone hydrogel, single vision contact lens for daily wear, daily disposable use
16217875|NCT01254747|Device|Nelfilcon A contact lens (DAILIES AquaComfort Plus)|Commercially marketed hydrogel, single vision contact lens for daily wear, daily disposable use
16217876|NCT01254747|Device|Narafilcon A contact lens (1-DAY ACUVUE TRUEYE)|Commercially marketed (Europe) silicone hydrogel, single vision contact lens for daily wear, daily disposable use
16217877|NCT01254734|Procedure|transoral robotic surgery|Undergo transoral robotic microsurgery
16217878|NCT01254734|Other|laboratory biomarker analysis|Correlative studies
16217879|NCT01254734|Procedure|quality-of-life assessment|Ancillary studies
16217880|NCT01254721|Drug|Quetiapine fumarate|eXtended Release(XR) 50mg, 200mg, 300mg and/or 400mg tablet, oral, once daily in the evening, from assignment to the end of the study.
16217881|NCT01254721|Drug|lithium|300mg tablet, oral
16217882|NCT01254708|Drug|Ambisome ®|liposomal amphotericin B
16217883|NCT01254708|Drug|Regular standard of care medication|Drug for this group is at the physician's discretion. Patients in this group receive the standard of care medication currently implemented at the Institution. Example would be voriconazole
16217884|NCT01254695|Device|Medtronic InterStim / InterStim II|Standard stimulation (Amplitude: sensory threshold, frequency 14 Hz, Pulsewidth 210 microsec.) will be compared wiht experimental setting 1,2,3,4
16217885|NCT01254682|Device|Ostenil|Standard arthroscopy (including intra-articular injection of 5 ml scandicain (0,5%), or 5 ml bupivacain plus 5 ml suprarenin in case of post-arthroscopic treatment). Add-on treatment with Ostenil after standard arthroscopic procedure. Application twice: first injection directly after arthroscopic procedure and second injection 3 weeks post arthroscopic.
16217886|NCT01254682|Procedure|Standard arthroscopic procedure|Standard arthroscopy (including intra-articular injection of 5 ml scandicain (0,5%), or 5 ml bupivacain plus 5 ml suprarenin in case of post-arthroscopic treatment) without add-on treatment.
16217887|NCT01254669|Behavioral|BNI-brief Negotiated Interview|use of a cognitive behavioral intervention to improve uptake of HPV vaccine
16217888|NCT01254656|Drug|lersivirine|Lersivirine 500 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily
16217889|NCT01254656|Drug|lersivirine|Lersivirine 750 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily
16217890|NCT01254656|Drug|efavirenz|Efavirenz 600 mg tablets PO taken once daily + tenofovir DF 300 mg/emtricitabine 200 mg tablets PO once daily
16217891|NCT01254656|Drug|lersivirine|Lersivirine 750 mg tablets PO taken once daily + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules PO taken twice daily + 1 optimized NRTI
16217892|NCT01254656|Drug|lersivirine|Lersivirine 1000 mg PO tablets + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules PO taken twice daily + 1 optimized NRTI
16217893|NCT01254656|Drug|etravirine|Etravirine 200 mg PO tablets + darunavir 600 mg tablets/ritonavir 100 mg tablets or capsules taken twice daily + 1 optimized NRTI
16217894|NCT01254643|Biological|V503|V503 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
16217895|NCT01254630|Biological|V212|V212 viral antigen for HZ, 0.5 mL subcutaneous (SC) injection per dose, in a four dose regimen, approximately 30 days apart.
16217896|NCT01254630|Biological|Placebo|Vaccine stabilizer for V212 with no virus antigen, 0.5 mL SC injection per dose, in a four dose regimen, approximately 30 days apart.
16217897|NCT01254617|Biological|Cetuximab|Given IV
16217898|NCT01254617|Other|Laboratory Biomarker Analysis|Correlative studies
16217899|NCT01254617|Drug|Lenalidomide|Given PO
16217900|NCT01254604|Drug|Preservative-Free Tafluprost or vehicle|Preservative-free tafluprost (0.0015%) ophthalmic solution; Preservative-free vehicle ophthalmic solution (contains no active drug)
16217901|NCT01254604|Drug|Preservative-Free Timolol maleate|Preservative-free timolol maleate (0.5%) ophthalmic solution
16217902|NCT01254591|Other|18F-fluoromisonidazole|
16217903|NCT01254591|Other|fluorescence angiography|
16217904|NCT01254591|Other|laboratory biomarker analysis|
16217905|NCT01254591|Procedure|infrared thermography|
16217906|NCT01254591|Procedure|magnetic resonance imaging|
16217907|NCT01254591|Procedure|therapeutic conventional surgery|
16217908|NCT01254591|Radiation|[18F]-ML-10|
16217909|NCT01254591|Radiation|fludeoxyglucose F 18|
16217910|NCT01254591|Radiation|rubidium Rb-82|
16217911|NCT01254578|Other|Laboratory Biomarker Analysis|Correlative studies
16217912|NCT01254578|Drug|Lenalidomide|Given orally
16217913|NCT01254578|Other|Pharmacological Study|Correlative studies
16217914|NCT01254565|Drug|Etelcalcetide|Administered intravenously (IV) at the end of hemodialysis
16217915|NCT01254565|Drug|Placebo|Administered intravenously at the end of hemodialysis
16217916|NCT01254552|Drug|iobitridol|Xenetix 350 was administered at a dose up to 180 ml, according to the patient's body weight measured on the day of administration.
16217917|NCT01254552|Drug|gadoterate meglumine|Dotarem was administered at a dose of 0.1 mmol/kg body weight (0.2 ml/kg body weight)
16217918|NCT01254539|Procedure|Laminectomy and bone marrow stem cells transplantation|"Autologous bone marrow cells collection under sedation. Sixty ml are obtained and processed through a ficoll gradient.
~T3-T4 laminectomy and bone marrow ficoll separated mononuclear autologous cells intraspinal transplantation"
16217919|NCT01254539|Procedure|Intrathecal infusion of autologous bone marrow stem cells|"Autologous bone marrow cells collection under sedation. Sixty ml are obtained and processed through a ficoll gradient.
~Patients were drawn 2 ml of cerebrospinal fluid and infused 2 ml (two 1 ml syringes) of Autologous Stem Cells."
16217920|NCT01254539|Procedure|Intrathecal infusion of placebo (saline solution).|Patients were infused 2 ml of saline solution
16217921|NCT01254526|Drug|GDC-0980|Oral repeating dose
16217922|NCT01254526|Drug|bevacizumab|Intravenous repeating dose
16217923|NCT01254526|Drug|paclitaxel|Intravenous repeating dose
16217924|NCT01254513|Drug|Docetaxel every 3 weeks + Prednisone|"Docetaxel IV 60 mg/m²/d then IV 70 mg/m²/d for subsequent cycles every 3 weeks
~Prednisone 10 mg/day continuously"
16217925|NCT01254513|Drug|Docetaxel weekly+ Prednisone|"Docetaxel weekly 35 mg/m²/day at day 1 and day 8 of each cycle (J1 = J21)
~Prednisone 10 mg/day continuously"
16217926|NCT01254474|Device|Cardiac chambers mapping with MAP 4|
16217927|NCT01254461|Drug|AZD1981|100 mg per oral, twice daily for 8 days
16217928|NCT01254461|Drug|AZD1981|4x100 mg per oral, twice daily for 8 days
16217929|NCT01254461|Drug|pravastatin|40 mg, once daily at Day 1, period A and Day 8, period B
16217930|NCT01254448|Drug|TC-5619|Group 1: 25 mg TC-5619 administered once daily for 28 days. Group 2: 50-150 mg TC-5619 administered once daily for 10 days.
16217931|NCT01254448|Drug|Placebo|Group 1: matching placebo administered once daily for 28 days. Group 2: matching placebo administered once daily for 10 days.
16217932|NCT01254435|Procedure|Colonoscopy|Recording of colonoscopic extubation
16217933|NCT01254422|Biological|Live, attenuated, recombinant dengue serotypes 1, 2, 3, and 4 virus|0.5 mL (at 0, 6, and 12 months), Subcutaneous suspension
16217934|NCT01254422|Biological|Placebo: NaCl 0.9%|0.5 mL (at 0, 6, and 12 months), Subcutaneous suspension
16217935|NCT01254409|Biological|PRM-151|Intravenous PRM-151 administered over 30 minutes on study days 1, 3, 5, 8, and 15 at doses of 1.0, 5.0, or 10.0 mg/kg.
16217936|NCT01254409|Other|Placebo|Intravenous 0.9% normal saline administered over 30 minutes on study days 1, 3, 5, 8, and 15.
16217937|NCT01254396|Drug|Sildenafil|Orally Disintegrating Tablet, 50 mg, Single Dose
16217938|NCT01254396|Drug|Sildenafil|Orally Disintegrating Tablet, 50 mg, Single Dose
16217939|NCT01254383|Drug|Sildenafil Tablet|Tablet, 50 mg, Single Dose
16217940|NCT01254383|Drug|Sildenafil ODT|Orally Disintegrating Tablet, 50 mg, Single Dose
16217941|NCT01254383|Drug|Sildenafil ODT|Orally Disintegrating Tablet, 50 mg, Single Dose
16217942|NCT01254370|Drug|Latanoprost|0.005%
16217943|NCT01254370|Drug|Travatan Z|0.004%
16217944|NCT01254357|Other|Questionnaire self report|Burn specific outcome measurement and global health measurement
16217945|NCT01254344|Drug|ertapenem sodium|Ertapenem sodium 1 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision
16217946|NCT01254344|Drug|ceftriaxone sodium|Ceftriaxone sodium 2 g administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision
16217947|NCT01254344|Drug|placebo to metronidazole|Placebo (0.9% sodium chloride) administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision
16217948|NCT01254344|Drug|metronidazole|Metronidazole 500 mg administered IV as a single dose over 30 minutes within 2 hours prior to the initial surgical incision
16218100|NCT01253070|Other|Questionnaire Administration|Ancillary studies
16217949|NCT01254331|Drug|tocilizumab [RoActemra]|tocilizumab 8 mg/kg intravenous infusion every 4 weeks for a total of 6 infusions
16217950|NCT01254318|Other|Standard Care|Health-care interventions will be recorded; no additional procedures outside the standard of care will be required.
16217951|NCT01254305|Drug|Levomilnacipran ER|Drug: Levomilnacipran ER (40 -120 mg/day) Study drug is to be given orally, in capsule form, once daily for 8 weeks
16217952|NCT01254305|Drug|Paroxetine, Sertraline, Citalopram or Fluoxetine.|Paroxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Sertraline (50, 100, or 150 mg/day) to be given orally, in capsule form, once daily for 8 weeks, or Citalopram (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks or Fluoxetine (20, 40, or 60 mg/day) to be given orally, in capsule form, once daily for 8 weeks
16217953|NCT01254305|Drug|Placebo|Matching placebo capsules, oral administration, once daily dosing
16217954|NCT01254292|Drug|Levonorgestrel IUD (LCS, BAY86-5028)|LCS12 insertion will occur at randomization visit (Visit 2). Duration of study treatment is 18 months with optional extension to 36 months for subjects in this group only.
16217955|NCT01254292|Drug|Yasmin (EE30/DRSP, BAY86-5131)|Combined oral contraceptive (COC; Yasmin; 0.03 mg ethinyl estradiol and 3 mg drospirenone); Subjects will start taking COC at / on the day of visit 2 and continue taking one pill / day without any breaks for the entire study duration of 18 months.
16217956|NCT01254279|Drug|CABAZITAXEL|Pharmaceutical form: Concentrate For Solution For Infusion Route of administration: Intravenous
16217957|NCT01254266|Behavioral|inpatient hospitalization and follow up|An inpatient program and a 1-year weekly follow up that include multi-disciplinary interventions for weight reduction and maintenance.
16217958|NCT01254266|Behavioral|inpatient treatment and follow up|one month inpatient treatment followed by a year-long follow up on the inpatient unit.
16217959|NCT01254266|Procedure|bariatric surgery|bariatric surgery.
16217960|NCT01254266|Behavioral|inpatient treatment with follow up|1 month inpatient treatment followed by a year-long follow up on the inpatient unit.
16217961|NCT01254253|Device|Percutaneous coronary intervention, PCI|PCI was performed using standard techniques for CTO.
16217962|NCT01254240|Device|UVA / UVB phototherapy|UVA / UVB phototherapy
16217963|NCT01254240|Device|UVB phototherapy|UVB phototherapy
16217964|NCT01254227|Drug|Deferasirox and Deferoxamine|
16217965|NCT01254214|Behavioral|tMBSR|MBSR is an 8-week program of mindfulness meditation and gentle Hatha yoga, taught in a class of up to 30 participants. The telephone-adapted MBSR program (tMBSR) begins with a 5 hour-day workshop to introduce the techniques, followed by 6 weekly 1 ½ hour group teleconferences with the teacher to discuss the class's experiences with meditation practice, and ends with a 5 hour retreat in week 8.
16217966|NCT01254214|Behavioral|Support group|The attention control consists of a support group emphasizing communication skills and selecting resources. It includes two 90 minute in-person workshops and 6 1-hour teleconference calls. An experienced facilitator emphasizes communication skills and group support.
16217967|NCT01254188|Drug|Nilotinib|This was an open-label, single-arm, prospective, multi-center, Phase IIIb clinical study with nilotinib 300 mg bid treatment in newly diagnosed CML-CP patients not previously treated with imatinib therapy and diagnosed within 6 months of study entry. For patients insufficiently responding to nilotinib 300 mg bid, the dose may have been increased to 400 mg bid. Among patients with adverse events who had dose reduction, this study also allowed a possible re-escalation to 300 mg bid.
16217968|NCT01254175|Biological|rHPIV3cp45 Vaccine|10^5 TCID^50 of rHPIV3cp45 vaccine, delivered as nose drops
16217969|NCT01254175|Biological|Placebo Vaccine|Placebo vaccine, delivered as nose drops
16217970|NCT01254162|Drug|MTC896 Gel|0.75% w/w gel applied daily for 28 days to the forehead
16217971|NCT01254136|Drug|INCB007839 300mg BID|INCB007839 tablets (300 mg BID) in combination with trastuzumab and vinorelbine will be administered in an initial Cycle of 28 days and followed by continuous 21-day cycles subsequently. Trastuzumab will be administered in continuous 21-day cycles beginning on Day 8 of Cycle 1. Vinorelbine will be administered on a weekly schedule for a minimum of the first four cycles beginning on Cycle 1 Day 8. All drugs will be administered continuously as tolerated or until a protocol-defined stopping criteria is met.
16217972|NCT01254136|Drug|Trastuzumab|INCB007839 tablets (300 mg BID) in combination with trastuzumab and vinorelbine will be administered in an initial Cycle of 28 days and followed by continuous 21-day cycles subsequently. Trastuzumab will be administered in continuous 21-day cycles beginning on Day 8 of Cycle 1. Vinorelbine will be administered on a weekly schedule for a minimum of the first four cycles beginning on Cycle 1 Day 8. All drugs will be administered continuously as tolerated or until a protocol-defined stopping criteria is met.
16217973|NCT01254136|Drug|Vinorelbine|INCB007839 tablets (300 mg BID) in combination with trastuzumab and vinorelbine will be administered in an initial Cycle of 28 days and followed by continuous 21-day cycles subsequently. Trastuzumab will be administered in continuous 21-day cycles beginning on Day 8 of Cycle 1. Vinorelbine will be administered on a weekly schedule for a minimum of the first four cycles beginning on Cycle 1 Day 8. All drugs will be administered continuously as tolerated or until a protocol-defined stopping criteria is met.
16217974|NCT01254123|Drug|Exenatide infusion|"On arrival to our cardiac care unit (CCU) and after informed consent patients will be randomized to Exenatide infusion or Placebo infusion. Patients in the Exenatide group will immediately be treated be with Exenatide iv, 5ug bolus in 30 minutes, followed by a continuous Exenatide infusion of 20ug/ 24 hours.
~Exenatide preparation: Byetta injection pens containing 1,2 ml (concentration 0,25 mg/ml; 60 doses of 5 μg) will be obtained. 3 doses (15 μg) will be diluted in 49 ml saline and 1 ml Human Serum Albumen (Cealb 200g/L, 10ml) to get a total of 50 ml containing 15 μg exenatide (or 300 ng exenatide / ml). A 50cc syringe will be placed in a pump system that is connected with a cannula in the patient's vein. The infusionrate will be 33,3 ml/hr for the first 30 minutes, followed by an infusion rate of 2,8 ml/hr for 72 hours. New 50cc syringes will be made every 8 hours."
16217975|NCT01254123|Drug|Placebo infusion.|"On arrival to our cardiac care unit (CCU) and after informed consent patients will be randomized to Exenatide infusion or Placebo infusion. Patients in the placebo group will immediately be treated with placebo infusion.
~Placebo preparation: 49ml saline and 1ml Human Serum Albumen (Cealb 200g/L, 10ml) to get a total of 50 ml will be placed in a 50cc syringe and placed in a pump system that is connected with a cannula in the patient's vein. The infusionrate will be 33,3 ml/hr for the first 30 minutes, followed by an infusion rate of 2,8 ml/hr for 72 hours. New 50cc syringes will be made every 8 hours."
16217976|NCT01254097|Dietary Supplement|Probiotic|Probiotic capsule, 2 capsules twice daily
16217977|NCT01254084|Dietary Supplement|Gynostemma Pentaphyllum tea|6g/day per oral, twice a day in 10 weeks, 30 minutes before breakfast and dinner
16217978|NCT01254084|Dietary Supplement|Placebo tea|6g/day per oral, twice a day in 10 weeks, 30 minutes before breakfast and dinner
16217979|NCT01254071|Drug|Dutasteride (0.5mg); Tamsulosin hydrochloride (0.2mg); fixed dose combination product of duatsteride (0.5mg) and tamsulosin hydrochloride (0.2mg)|In the first dosing session, twenty-two subjects of each cohort will receive the FDC capsule (dutasteride and tamsulosin hydrochloride (0.5mg/0.2mg) and the other 22 will receive commercial capsules of dutasteride 0.5mg and commercial tablets of tamsulosin hydrochloride 0.2mg co-administered. Following a wash-out period of at least 28 days, those subjects who received the FDC capsule in session 1, will be co-administered commercial capsules of dutasteride 0.5mg and commercial tablets of tamsulosin hydrochloride 0.2mg while those who were co-administered commercial capsules of dutasteride 0.5mg and commercial tablets of tamsulosin hydrochloride 0.2mg in session 1 will receive the FDC capsule in the second dosing session.
16217980|NCT01254045|Drug|placebo|intranasal placebo (48 international units)
16217981|NCT01254045|Drug|oxytocin 24IU|intranasal oxytocin (24 international units) and intranasal placebo (24 international units)
16217982|NCT01254045|Drug|oxytocin 48IU|intranasal oxytocin (48 international units)
16217983|NCT01254019|Drug|GSK2402968 6mg/kg/week|subcutaneous
16217984|NCT01254006|Drug|forskolin, rutin and vitamins B1 and B2|
16217985|NCT01253980|Drug|Amoxicillin|Amoxicillin syrup 20-30mg/kg 8 hourly for 5 days
16217986|NCT01253980|Drug|Placebo|"Placebo suspension made of water, dextrose and glycerine with a similar taste and appearance to the active comparator.
~Dose 20-30mg/kg 8 hourly for 5 days"
16217987|NCT01253967|Procedure|Collection of stool samples|Stool samples will be tested for the presence of rotavirus and a subset of rotavirus positive samples will be genotyped.
16217988|NCT01253967|Other|Health economics questionnaire|For a subset of subjects, additional economic data will be gathered by completing a questionnaire
16217989|NCT01253941|Other|Mud bath Therapy|patients will be randomized to Mud bath Therapy ( 12 sessions) or no treatment
16217990|NCT01253928|Drug|Pioglitazone|45mg qd for 4 months
16217991|NCT01253915|Drug|Nasal Carbon Dioxide|10 sec/nostril up to 4 times to treat one migraine
16217992|NCT01253915|Drug|Placebo|10 sec/nostril up to 4 times to treat a migraine
16217993|NCT01253902|Drug|bimatoprost ophthalmic solution 0.01%|One drop of bimatoprost ophthalmic solution 0.01% administered to affected eye(s), once daily in the evening for 12 weeks.
16217994|NCT01253902|Drug|travoprost ophthalmic solution 0.004%|One drop of travoprost ophthalmic solution 0.004% administered to affected eye(s), once daily in the evening for 12 weeks.
16217995|NCT01253902|Drug|latanoprost ophthalmic solution 0.005%|One drop of latanoprost ophthalmic solution 0.005% administered to affected eye(s), once daily in the evening for 12 weeks.
16217996|NCT01253889|Drug|Glucose 25% oral solution|0.5ml of 25% glucose (26-31 weeks gestational age group) or 1.0 ml of 25% glucose (32-42 weeks gestational age group). This application can be repeated if necessary to a maximum of four times, adding up to max 2ml of 25% glucose in the 26-31 weeks gestational age group or 4ml of 25% glucose in the 32-42 weeks gestational age group.
16217997|NCT01253889|Other|Oral water|0.5ml of oral water (26-31 weeks gestational age group) or 1.0 ml of oral water (32-42 weeks gestational age group). This application can be repeated if necessary to a maximum of four times, adding up to max 2ml of oral water in the 26-31 weeks gestational age group or 4ml of oral water in the 32-42 weeks gestational age group.
16217998|NCT01253876|Dietary Supplement|soy milk, Caw's milk|
16217999|NCT01253863|Other|exploration|exploration of wound for determining damaged tissue
16218000|NCT01253837|Drug|L19TNFa|"Phase I: Sequential assignment of Patient cohorts to one of six dose levels of L19TNFa: 1.3, 2.6, 5.2, 7.8, 10.4, 13.0 µg/kg.
~Phase II: The Recommended Dose (RD) of 13.0 µg/kg of L19TNFα determined in Phase I.
~Schedule: Infusions of L19TNFα on days 1, 3 and 5 of each 21-day cycle. Patients may remain on treatment for a maximum of six 21-day cycles."
16218001|NCT01253824|Drug|NPC-01|NPC-01 contains 1mg norethisterone and 0.02mg ethinyl estradiol
16218002|NCT01253824|Drug|IKH-01|IKH-01 contains 1mg norethisterone and 0.35mg ethinyl estradiol
16218003|NCT01253811|Drug|catridecacog|Intravenous injection of a single dose of recombinant factor XIII, 35 IU/kg body weight every 4th week
16218004|NCT01253798|Other|Group training|Each session lasts 50 minutes and consists of warm-up, mobility training, strength training, balance training and endurance training. Mobility training is conducted to increase range of motion in the operated hip, strength exercises are conducted to strengthen muscles around the operated hip, balance training are conducted to improve stability around the operated hip and endurance training are conducted to increase patients' physical capacity. This is in line with current guidelines for the exercise of osteoarthritis patients.
16218005|NCT01253759|Procedure|TTT + ICG-based PDT|
16218006|NCT01253733|Behavioral|MD2ME|The goals of the MD2Me intervention include increasing disease self-efficacy, disease knowledge, and the ability to control one's disease independently. The intervention includes an 8-week web program with weekly behavioral skills, topics on how to navigate the healthcare system, lifestyle tips, a Discussion Board, and text messages.
16218007|NCT01253720|Behavioral|PACE CALL/Fit4Life|"The Fit4Life E intervention will be designed to promote weight loss and subsequent weight loss maintenance through the adoption and maintenance of improved eating, physical activity and sedentary behaviors in at risk for overweight and overweight adolescent survivors of ALL and their parent/guardian. the Fit4Life intervention will incorporate elements of the Chronic Care Model, including frequent phone and mail interactions, an initial in-person encounter to provide encouragement and initial patient-tailored counseling for obesity management, family-centered skill development to achieve healthy behavioral modification via goal setting, self-monitoring, and problem solving.
~The Fit4Life intervention includes:
~Web-based weight loss program Text and Picture messages Counseling Calls Health Coach"
16218008|NCT01253707|Drug|AMG 337|AMG 337 is a small molecule inhibitor of c-Met which is a receptor tyrosine kinase expressed on the surface of epithelial cells.
16218009|NCT01253694|Drug|injection of 0.5 mg of Intravitreal Ranibizumab|Following the sterile technique, intravitreal injection of anti-VEGF is applied
16218101|NCT01253070|Drug|Sorafenib Tosylate|Given PO
16220286|NCT01236261|Other|Non intervention|Non interventional study
16218010|NCT01253681|Drug|AMG 386, paclitaxel and carboplatin|15 mg/Kg AMG 386 IV (intravenous) weekly plus paclitaxel and carboplatin IV Q3W for 18 weeks, followed by 15mg/Kg AMG 386 IV (intravenous) weekly alone for an additional 18 months.
16218011|NCT01253668|Drug|Brivanib alaninate|Brivanib by mouth daily at a dose of 800mg.
16218012|NCT01253668|Genetic|Polymerase chain reaction|Undergo 1241-cG250 PET/CT imaging (correlative studies)
16218013|NCT01253668|Other|Iodine I 124 chimeric monoclonal antibody G250|Undergo 124I-cG250 PET/CT imaging (correlative studies)
16218014|NCT01253668|Procedure|Positron emission tomography/computed tomography|Undergo 1241-cG250 PET/CT imaging (correlative studies)
16218015|NCT01253668|Genetic|Protein expression analysis|Correlative studies
16218016|NCT01253668|Other|Immunohistochemistry|correlative studies
16218017|NCT01253655|Drug|PF-05212365|Single dose of up to 30 mg PF-05212365, delivered as 1 mg, 3 mg, and/or 5 mg on study day 1.
16218018|NCT01253642|Procedure|Biopsy of Prostate|Undergo transrectal ultrasound (TRUS) guided prostate biopsy OR image-guided (CT or ultrasound) core bone or soft tissue biopsy
16218019|NCT01253642|Drug|Docetaxel|Given IV
16218020|NCT01253642|Other|Laboratory Biomarker Analysis|Correlative studies
16218021|NCT01253642|Drug|Phenelzine Sulfate|Given PO
16218022|NCT01253629|Drug|AFQ056|AFQ056, was provided as hard gelatin capsules, 25mg and 100 mg oral dosage strengths, identical in appearance were used
16218023|NCT01253629|Drug|Placebo|Placebo medication identical in appearance to active medication was provided
16218024|NCT01253616|Device|vagus nerve stimulation (VNS)|Daily stimulation synchronized with tones at the study assigned dose (amplitude, frequency, on/off cycle and treatment period).
16218025|NCT01253603|Drug|QAW039 capsules once daily for 28 days|
16218026|NCT01253603|Drug|Placebo to QAW039 capsules once daily for 28 days|
16218027|NCT01253603|Drug|Fluticasone propionate inhaler twice daily for 28 days|
16218028|NCT01253590|Behavioral|questionnaire about the use of ECG device|Patients will be fitted with a continuous ECG monitor and blood pressure device. Data on every heart beat, including episodes of atrial fibrillation, for 4-6 weeks of continuous monitoring will be collected and transmitted wirelessly. Based on this information and blood pressure readings performed by patients in their home setting, clinicians can adjust oral coagulant dosage. Participants will attend 2 follow-up outpatient visits at the MSKCC outpatient cardiology practice upon the cardiologist's recommendation. Upon completion of the study, 4-6 weeks, a questionnaire will be sent via mail, including a pre-paid envelope, to participants to assess feasibility, acceptance, and overall experience with remote cardiac monitoring.
16218029|NCT01253577|Device|Sinus Stent with drug coating|Sinus stent coated with 370 ug of the corticosteroid mometasone furoate
16218030|NCT01253577|Device|Non Coated Sinus Stent|Sinus stent (visually identical) without drug coating
16218031|NCT01253564|Drug|RO5185426|960 mg b.i.d. orally
16218032|NCT01253551|Drug|Treatment sequence AB|Treatment A: telaprevir 750 mg every 8 hours on Days 1 to 6, with a morning dose on Day 7. Treatment B: raltegravir 400 mg twice a day on Days 1 to 10 and telaprevir 750 mg every 8 hours on Days 5 to 10, with a morning dose of raltegravir, and a morning and afternoon dose of telaprevir on Day 11.
16218033|NCT01253551|Drug|Treatment sequence BA|Treatment A: telaprevir 750 mg every 8 hours on Days 1 to 6, with a morning dose on Day 7. Treatment B: raltegravir 400 mg twice a day on Days 1 to 10 and telaprevir 750 mg every 8 hours on Days 5 to 10, with a morning dose of raltegravir, and a morning and afternoon dose of telaprevir on Day 11.
16218034|NCT01253525|Biological|Ramucirumab (IMC-1121B )|8 milligrams/kilogram (mg/kg) intravenously on Days 1 and 15 of each 28-ay cycle
16218035|NCT01253525|Drug|Paclitaxel|80 milligram/square meter (mg/m2) intravenously Days 1, 8, and 15 of each 28 day cycle
16218036|NCT01253512|Drug|THR-18|A single 0.25 or 0.5 mg/kg of THR-18 in combination with tPA treatment.
16218037|NCT01253512|Drug|Placebo|Intravenous
16218038|NCT01253499|Drug|TRx0037|75mg and 100mg tablets used to create doses of 100mg and 175mg. Active placebo 2mg and blank placebo used as comparators.
16218039|NCT01253486|Behavioral|Disease-related Expressive writing|Participants in the disease-related expressive writing condition write about their feelings about cardiac disease four times, for at least 20 minutes each time, during a two week period.
16218040|NCT01253486|Behavioral|Active Comparator: Traditional expressive writing|Participants in the traditional expressive writing condition write about their feelings about one or more stressful experiences they lived in the past, for at least 20 minutes each time, during a two week period
16218041|NCT01253486|Behavioral|Sham Comparator: Neutral writing|Participants in the neutral writing condition write about the facts about cardiac disease, for at least 20 minutes each time, during a two week period
16218042|NCT01253473|Drug|Budesonide|Inhaled budesonide twice daily plus inhaled ipratropium/albuterol combination four times daily and every 4 hours as needed
16218043|NCT01253473|Drug|budesonide/formoterol|Inhaled budesonide/formoterol (160/4.5 mcg Symbicort®) 2 puffs twice daily plus inhaled ipratropium/albuterol (Combivent®) 1 puff four times daily
16218044|NCT01253473|Drug|Ipratropium/albuterol|Inhaled ipratropium/albuterol combination 2 puffs four times daily
16218045|NCT01253460|Drug|Cyclophosphamide|250 mg/m2 by vein (IV) over 30 minutes, 2 hours following the dose of Sapacitabine on days 1, 2, and 3 of each 28 day course.
16218046|NCT01253460|Drug|Rituximab|375 mg/m2 by vein over 6 - 8 hours on day 3 of course 1 after cyclophosphamide, then at 500 mg/m2 on day 1, after cyclophosphamide for subsequent courses. Each course is 28 days.
16218047|NCT01253460|Drug|Sapacitabine|350 mg flat dose by mouth in the morning of days 1,2, and 3 of each 28 day course.
16218048|NCT01253447|Drug|Akt inhibitor MK2206|200 mg orally (PO) once weekly. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
16218049|NCT01253447|Other|laboratory biomarker analysis|Correlative studies
16218050|NCT01253434|Drug|E2022|E2022 Type A patch
16218051|NCT01253434|Drug|E2022|E2022 Type B patch
16218052|NCT01253434|Drug|E2022|E2022 Type C patch
16218053|NCT01253434|Drug|E2022|E2022 Type D patch
16218054|NCT01253434|Drug|E2022|E2022 Type E patch
16218055|NCT01253421|Drug|amisulpride|single low-dose pharmacological challenge, 50 mg amisulpride
16218056|NCT01253421|Drug|placebo|single-dose placebo capsule
16218057|NCT01253408|Drug|Dronabinol|Dronabinol is a synthetic delta-9-tetrahydrocannabinol, a nonselective cannabinoid agonist. Subjects will receive either 2.5 mg bid, or 5 mg bid, taken orally with water for 2 days.
16218058|NCT01253408|Drug|Placebo|Placebo will match study drug; taken orally with water twice per day for two days.
16218059|NCT01253395|Behavioral|Strength training|Daily supervised strength training.
16218060|NCT01253395|Behavioral|Aerobic exercise|Daily supervised aerobic exercise.
16218061|NCT01253382|Biological|ecallantide|10 - 30mg subcutaneous injection.
16218062|NCT01253369|Drug|Pazopanib|
16218063|NCT01253356|Device|IABP|Insertion of intra-aortic balloon < or = 3 hours before noncardiac surgery and maintained > or = 12-24 hours after surgery
16218064|NCT01253330|Other|Text Message Reminders|During baseline (Participant 1st Arm) or Month 3 Visit (Comparison 1st Arm), the study staff member will demonstrate for the teen how to log-on to the calendar system and set up reminders. Teens will be able to set their own reminders and add other reminders in addition to those that are asthma related.
16218065|NCT01253317|Drug|rhIGF-1|1) Multiple ascending dose (MAD) period (4 weeks): Subjects will receive escalating twice-daily doses of IGF-1 over 4 weeks (40 µg/kg, 80 µg/kg, 120 µg/kg) and then continue treatment at 120 µg/kg BID for 20 weeks should they choose to enroll in the open-label extension period.
16218066|NCT01253304|Drug|LY2189265|Subcutaneous (SC) injection
16218067|NCT01253291|Drug|LY2127399|Administered subcutaneously every 4 weeks for 48 weeks
16218068|NCT01253278|Drug|LY2393910|as capsules, administered orally once daily for two weeks
16218069|NCT01253278|Drug|Placebo|as capsules, administered orally once daily for two weeks
16218070|NCT01253265|Drug|LY2439821|Administered subcutaneously
16218071|NCT01253265|Drug|Placebo|Administered subcutaneously
16218072|NCT01253252|Radiation|[18F] Fluorodeoxyglucose PET Scan Imaging|"Positron Emission Tomography (PET) is a nuclear medicine imaging technique which produces a 3-dimensional image of functional processes in the body. The system detects pairs of gamma rays emitted indirectly by a positron-emitting radionuclide, which is introduced into the body on a biologically active molecule. Images of tracer concentration in 3-dimensional space are then reconstructed by computer analysis.
~The biologically active molecule chosen for PET is 18-fluorodeoxyglucose. The concentrations of tracer imaged then give tissue metabolic activity, in terms of regional glucose uptake.
~The dose of 18FDG that is recommended for adults in a standard exploration varies from 200 to 500 MBq according to the weight of the patient and the camera used. No allergic or other incident has been observed after several thousands of examinations."
16218073|NCT01253252|Radiation|CT scan|Computed tomography (CT) is a medical imaging method employing tomography created by computer processing. Digital geometry processing is used to generate the PET's three-dimensional space image.
16218074|NCT01253252|Biological|Blood sampling for biological investigations|A venous blood sample of a total of 30 ml for measurement of enzymes associated with the development of aneurysms (= biomarkers).
16218075|NCT01253226|Drug|LY2127399 (Tabalumab)|Administered subcutaneously
16218076|NCT01253226|Drug|Placebo|Administered subcutaneously
16218077|NCT01253213|Drug|BR55|One to two bolus (2nd bolus optional) of BR55 per patient
16218078|NCT01253200|Device|Blazer® Open-Irrigated Ablation Catheter|Blazer® Open-Irrigated Ablation Catheter
16218079|NCT01253200|Device|Control Catheter|Open-irrigated radiofrequency ablation catheters that have received FDA market approval for the treatment of type 1 atrial flutter
16218080|NCT01253187|Drug|EE 0.02 mg/DRSP 3 mg (YAZ, BAY86-5300)|Treatment group A: Single 1 film-coated tablet (Ethinylestradiol [EE] 0.02mg / Drospirenone [DRSP] 3mg) taken orally under fasting condition at intervals of at least one menstrual cycle.
16218081|NCT01253187|Drug|EE 0.02 mg/DRSP 3 mg/L-5-MTHF Ca 0.451 mg (EE20/DRSP/L-5-MTHF Ca)|Treatment group B: Single 1 film-coated tablet (Ethinylestradiol [EE] 0.02mg / Drospirenone [DRSP] 3mg / L-5-methyltetrahydrofolate [L-5-MTHF] 0.451mg) taken orally under fasting condition at intervals of at least one menstrual cycle.
16218082|NCT01253187|Drug|L-5-MTHF 0.451mg (Metafolin)|Treatment group C: Single 1 coated tablet (L-5-methyltetrahydrofolate [L-5-MTHF] 0.451mg) taken orally under fasting condition at intervals of at least one menstrual cycle.
16218083|NCT01253174|Drug|EE 0.03 mg/DRSP 3 mg (Yasmin, BAY86-5131)|single oral administration of 1 coated tablet SH T470FA (Yasmin, film-coated tablets with ethinylestradiol (EE) as free steroid), containing 0.030 mg EE + 3 mg drospirenone (DRSP)
16218084|NCT01253174|Drug|EE 0.03mg/DRSP 3mg/L-5-MTHF Ca 0.451mg (EE30/DRSP/L-5-MTHF Ca)|single oral administration of 1 coated tablet SH T04532A (film-coated tablet with ethinylestradiol (EE) as clathtrate), containing 0.030 mg EE + 3 mg drospirenone (DRSP) + 0.451 mg Metafolin
16218085|NCT01253174|Drug|L-5-MTHF Ca 0.451 mg (Metafolin)|single oral administration of 1 coated tablet SH T04532C, containing 0.451 mg Metafolin
16218086|NCT01253161|Drug|Pasireotide Long Acting Release (LAR)|Pasireotide will be administered as an intramuscular injection at the beginning of every cycle which is defined as 28 days (+/- 3 days). Study treatment should begin within 14 days following enrollment into the study and continue until disease progression, unacceptable toxicity, or withdrawal of consent.
16218087|NCT01253148|Device|TheraSphere® Yttrium-90 (Y-90) Microspheres|Y-90 is incorporated into very tiny glass beads called microspheres and is injected into the liver through the blood vessels supplying the liver.
16218088|NCT01253135|Biological|Fibrin|Topical application of fibrinogen spray, followed by thrombin spray
16218089|NCT01253135|Other|White Petrolatum|Topical application
16218090|NCT01253122|Drug|TRx0037|
16218091|NCT01253109|Device|SENSIMED Triggerfish|Contact lens-based device for continuous IOP monitoring
16218092|NCT01253096|Drug|Intratumoral injections of L19IL2|Patients will be treated with intratumoral injections of L19IL2 1-3 x weekly. The maximum cumulative dose per week is 20 MioIU. Treatment duration is up to 20 weeks.
16218093|NCT01253083|Behavioral|mobility training with dynamic body weight support|
16218094|NCT01253070|Procedure|Biopsy|Undergo biopsy
16218095|NCT01253070|Procedure|Bone Marrow Aspiration|Undergo bone marrow aspirate
16218096|NCT01253070|Drug|Cytarabine|Given IV
16218097|NCT01253070|Drug|Daunorubicin Hydrochloride|Given IV
16218098|NCT01253070|Other|Laboratory Biomarker Analysis|Correlative studies
16218099|NCT01253070|Other|Quality-of-Life Assessment|Ancillary studies
16218102|NCT01253044|Behavioral|Acceptance and Commitment Therapy|Acceptance and Commitment Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
16218103|NCT01253044|Behavioral|Present Centered Therapy|Present Centered Therapy, delivered twelve 60-minute one-on-one treatment sessions over 6-10 weeks (additional weeks are permissible if needed).
16218104|NCT01253018|Behavioral|Robot Therapy|Robot assisted arm exercise for 60 minutes progressing each month through three robot modules: wrist, planar, and alternating sessions on the wrist and planar robot 3x/week for 12 weeks.
16218105|NCT01253018|Behavioral|Transition to Task Training|Robot therapy as described for 45 minutes and 15 minutes of task specific arm exercise using the hemiparetic arm 3x/week for 12 weeks.
16218106|NCT01253005|Behavioral|Nutritional intervention|This study will investigate the effects of particle size of different triglyceride emulsions as well as the dynamics of intragastric structure formation and breakdown of the emulsions on GI function, the kinetics of the endocrine and the satiation response in healthy volunteers.
16218107|NCT01252992|Genetic|Genetic analysis|"identification of candidates genes by a differential analysis of the whole transcriptome of the peripheral leucocytes of 20 PR+ patients and 20 RP- controls, at D0, D15, M2,;
~Genetic association analysis: comparison of allelic distributions of SNPs (diallelic markers) within the candidate genes, between PR+ and PR- patients, in the whole cohort.
~One supplementary ACD tube of 5 ml à D0, D15, M2, PR+, for RNA extraction."
16218108|NCT01252992|Radiation|Body scan (CERVICO THORACO ABDOMINAL) + Cranian IRM|at day 0, Month 2, paradoxical reaction, end of treatment, read by an independent radiologist
16218109|NCT01252992|Other|Immunologic analysis|For patients included until 20 PR+ : blood puncture of 4 ACD tubes of 10 ml, 1 EDTA tube of 7,5 ml et 1 heparinate lithium tube of 7,5ml at D0, D15, M2, and M6 and at the time of an potential RP+
16218110|NCT01252992|Other|QuantiferonTB Gold test|at M0, M2, M6 and in case of PR+.
16218111|NCT01252979|Dietary Supplement|Medium-Chain Triglycerides|Subjects will take supplemental MCT oil 3 times a day for 6 months
16218112|NCT01252966|Behavioral|Cognitive Training|The computerized cognitive training intervention is a 12-week standardized course of internet-based computerized cognitive exercises designed to enhance executive cognitive function.
16218113|NCT01252966|Behavioral|Control training|The computerized control training intervention is a 12-week standardized course of internet-based deep breathing exercises which does not contain the cognitive exercises designed to enhance executive cognitive function.
16218116|NCT01252940|Drug|FTC/RPV/TDF|Emtricitabine (FTC) 200 mg/rilpivirine (RPV) 25 mg/tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg single-tablet regimen (STR) administered orally with a meal once daily (QD)
16218117|NCT01252940|Drug|PI|Protease inhibitors (PIs) included amprenavir, atazanavir, darunavir, fosamprenavir, Kaletra (lopinavir/ritonavir, coformulated), ritonavir, and saquinavir. PIs were administered according to prescribing information.
16218118|NCT01252940|Drug|RTV|Ritonavir (RTV) was administered according to prescribing information.
16218119|NCT01252940|Drug|NRTIs|NRTIs included abacavir, emtricitabine, Combivir (lamivudine/zidovudine, coformulated), Epzicom (abacavir/lamivudine, coformulated), lamivudine, stavudine, tenofovir DF, Truvada® (emtricitabine/tenofovir DF, coformulated), and zidovudine. NRTIs were administered according to prescribing information.
16218120|NCT01252927|Other|ASIST|The gatekeeper training intervention group will receive the Applied Suicide Intervention Skills Training (ASIST) workshop in addition to training as usual. ASIST is a 2-day intensive, interactive and practice-dominated course aimed at enabling people to recognize risk and learn how to intervene immediately to prevent suicide.
16218121|NCT01252914|Device|iStent Supra Stent|Implantation of one iStent Supra Stent through a small temporal clear corneal incision
16218122|NCT01252888|Device|iStents|Implantation of two iStents through a small temporal clear corneal incision
16218123|NCT01252875|Procedure|Target : 100 mg/dL (+/-10 mg/dL)|Statin +/- other lipid lowering therapy during 3 years, Target : LDL-C =100 mg/dL (+/-10 mg/dL), recording recurrent non fatal stroke, non fatal MI, and vascular death and others endpoints such as new onset diabetes, hemorrhagic strokes.
16218124|NCT01252875|Procedure|70 mg/dL|Statin +/-lipid lowering therapy during eight and a half years maximum, Target : LDL-C concentration of less than 70 mg/dL, recording recurrent of non fatal stroke, non fatal IM, and vascular death and others endpoints such as: new onset diabetes, hemorrhagic strokes.
16218125|NCT01252862|Device|iStent|Implantation of two iStents through a small temporal clear corneal incision
16218126|NCT01252849|Device|iStent|Implantation of One iStent through a small temporal clear corneal incision.
16218127|NCT01252849|Device|iStent|Implantation of Two iStents through a small temporal clear corneal incision
16218128|NCT01252849|Device|iStent|Implantation of Three iStents through a small temperal clear corneal incision
16218129|NCT01252836|Device|AWBAT-D|Application of AWBAT-D bioengineered device
16218130|NCT01252823|Device|Implantation of ILR|Subcutaneous implantation of ILR under local anesthesia
16218131|NCT01252810|Drug|GE-145|GE-145-320 mg I/mL as a single iv. administration. Comparator agent Isovue (iopamidol) 370 mg I/mL as a single iv. administration.
16218132|NCT01252797|Radiation|Stereotactic Radiosurgery (15 Gy)|"Group A will start at dose level II: 15 Gy
~Group B will start at dose level I: 12 Gy"
16218133|NCT01252797|Radiation|Stereotactic Radiosurgery (12 Gy)|Group B will start at Dose Level I: 12 Gy
16218134|NCT01252771|Other|PKM Algorithm|"The subject's serum calcium and phosphorus values will be input into PKM in order to determine the required PhosLo prescription. The prescription is determined as the number of gelcaps per day that must be taken by the subject.
~If PKM determines the number of PhosLo gelcaps per day to be greater than or equal to the subject's current prescription, then PKM will calculate the current Ca++ and phosphate balance. Furthermore, the PKM algorithm will determine the additional number of PhosLo gelcaps needed to achieve neutral phosphate (P) balance with serum P reduced to 5.5 mg/dL.
~The PKM algorithm also calculates the total P intake between dialyses and along with ePCR also calculates a Phosphorus/Protein Ratio (PPR). This ratio ranges from 8 to 14 in dialysis patients following a renal diet."
16218135|NCT01252758|Drug|albuterol sufate DPI (TBS-7) dose 1|
16218136|NCT01252758|Drug|albuterol sufate DPI (TBS-7) dose 2|
16218144|NCT01252732|Drug|Single-Dose IV Oritavancin Diphosphate|Intravenous oritavancin and IV placebo or IV vancomycin will be administered for a minimum of 7 days up to a maximum of 10 days.
16218145|NCT01252732|Drug|IV Vancomycin|Intravenous oritavancin and IV placebo or IV vancomycin will be administered for a minimum of 7 days up to a maximum of 10 days.
16218146|NCT01252719|Drug|Single-Dose IV Oritavancin Diphosphate|Intravenous oritavancin and IV placebo or IV vancomycin will be administered for a minimum of 7 days up to a maximum of 10 days.
16218147|NCT01252719|Drug|IV Vancomycin|Intravenous oritavancin and IV placebo or IV vancomycin will be administered for a minimum of 7 days up to a maximum of 10 days.
16218148|NCT01252706|Behavioral|brief intervention|limit time giving information, motivation, empathy, responsibility, self control
16218149|NCT01252693|Drug|Ozarelix|Ozarelix Loading dose of 130 mg SC at randomization will be followed by maintenance dosing of 65 mg SC at day 8, 28 and 56.
16218150|NCT01252693|Drug|Goserelin|Goserelin depot 3.6 mg at randomization will be followed by 3.6 mg SC on days 28 and 56.
16218151|NCT01252680|Biological|Healive+Healive|Hepatitis A vaccine (Healive), 250 u per dose per 0.5 millilitre. Vaccines will be administered two doses in the deltoid muscle of the arm 6 months apart
16218152|NCT01252680|Biological|Healive+Havrix|Two kinds of Hepatitis A vaccines, Healive(250 u per dose per 0.5 millilitre) and Havrix(720 ELU per dose per 0.5 millilitre). The first dose will be administered with Healive, followed by another dose of Havrix after 6 months
16218153|NCT01252680|Biological|Havrix+Havrix|Hepatitis A vaccine (Havrix), 720 ELU per dose per 0.5 millilitre. Vaccines will be administered two doses in the deltoid muscle of the arm 6 months apart
16218154|NCT01252680|Biological|Havrix+Healive|Two kinds of Hepatitis A vaccines, Healive(250 u per dose per 0.5 millilitre) and Havrix(720 ELU per dose per 0.5 millilitre). The first dose will be administered with Havrix, followed by another dose of Healive after 6 months
16218155|NCT01252667|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic hematopoietic PBSCT
16218156|NCT01252667|Drug|Clofarabine|Given IV
16218157|NCT01252667|Drug|Cyclosporine|Given PO
16218158|NCT01252667|Other|Laboratory Biomarker Analysis|Correlative studies
16218159|NCT01252667|Drug|Mycophenolate Mofetil|Given PO
16218160|NCT01252667|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo allogeneic hematopoietic PBSCT
16218161|NCT01252667|Other|Pharmacological Study|Optional correlative studies
16218162|NCT01252667|Radiation|Total-Body Irradiation|Undergo TBI
16218163|NCT01252641|Biological|SB-728-T|Each infusion will be 5-30 billion modified CD4+ T-cells
16218164|NCT01252628|Drug|PX-866 (SCCHN)|PX-866 administered at the MTD/RD in combination in patients administered weekly on a 21 day cycle.
16218165|NCT01252628|Drug|Cetuximab (SCCHN)|Cetuximab administered weekly on a 21 day cycle, as standard of care in patients.
16218166|NCT01252628|Drug|PX-866 (CRC)|PX-866 administered at the MTD/RD in combination in patients administered weekly on a 21 day cycle.
16218167|NCT01252628|Drug|Cetuximab (CRC)|Cetuximab administered weekly on a 21 day cycle in patients, as standard of care.
16218168|NCT01252615|Behavioral|patient only|education, behavioral strategies, psychological interventions
16218169|NCT01252615|Behavioral|patient and partner intervention|education, psychological support, behavioral strategies
16218170|NCT01252589|Other|HRQOL questionnaire|
16218171|NCT01252563|Drug|Amlodipine|Usual adult dosage is 2.5-5 mg of amlodipine given orally as a single daily dose. Dosage should be adjusted depending on the patient's symptoms. The dose can be raised up to 10 mg once daily for patients who show inadequate response.
16218172|NCT01252550|Dietary Supplement|Activia® (125g/pot)|Activia® (125g/pot) - dairy product containing bacterial culture Acti Regularis®
16218173|NCT01252550|Dietary Supplement|Acidified non-fermented dairy product|Acidified non-fermented dairy product (125g/pot)
16218174|NCT01252524|Drug|Placebo|Placebo tablet po TID before each meal with 8 oz of water for 6 months
16218175|NCT01252524|Drug|Calcium polycarbophil|calcium polycarbophil 625 mg po TID before each meal with 8 oz water for 6 months
16218176|NCT01252511|Procedure|RYGB for surgical treatment of severe obesity|Twenty severely obese patients who have been scheduled to receive long limb RYGB will be enrolled in the study. By randomization, 10 patients will have a biliopancreatic limb that includes 40 cm of jejunum and a Roux limb that contains 150 cm of jejunum. The other 10 patients will receive a biliopancreatic limb that contains 75 cm of jejunum and a Roux limb of 115 cm.
16218177|NCT01252459|Radiation|Radiation Therapy|Experimental intervention (Arm A): High-precision re-irradiation (stereotactic fractionated radiation therapy (SFRT) and/or image guided radiation therapy, (IGRT), total dose 39 Gy, 3 Gy/d, 5x/ week. Target volume delineation based on AA-PET: GTV = AA uptake on PET, clinical target volume (CTV) = GTV+3mm, PTV = CTV+2mm
16218178|NCT01252459|Radiation|Radiation Therapy|Control intervention (Arm B): High-precision re-irradiation (SFRT and/or IGRT), total dose 39 Gy, 3 Gy/d, 5x/ week. Target volume delineation based on T1Gd-MRI: GTV = contrast enhancement on T1Gd-MRI, CTV = GTV+3mm, PTV = CTV+2mm
16218179|NCT01252433|Other|Energy density feeding study|In a crossover study, children are served all foods 1 day a week for 3 weeks. Meal entrees will vary in energy density (100%, 85%, 75%).
16218180|NCT01252420|Drug|Enoxaparin|1.5mg/kg daily for 2 weeks
16218181|NCT01252407|Other|transcutaneous electrical nerve stimulation|Application of low frequency (10-Hz) and high frequency (100-Hz) TENS, in two different days
16218182|NCT01252381|Other|12 weeks Strength exercise training|Training 3 times a week, leg extensions and leg press
16218183|NCT01252368|Biological|hypertension|patients taking daily ACE inhibitors or sartanes
16218184|NCT01252355|Drug|Teriflunomide|"Film-coated tablet
~Oral administration"
16218185|NCT01252355|Drug|Placebo (for teriflunomide)|"Film-coated tablet
~Oral administration"
16218186|NCT01252355|Drug|Interferon-beta (IFN-beta)|"Any of the IFN-beta which are approved for marketed use in the country where the patient is enrolled.
~Administration according to the package insert."
16218187|NCT01252342|Drug|Oxytocin|10 U intramyometrial oxytocin bolus immediately after cesarian delivery, and an infusion of 20 U/L of oxytocin at 500ml/hr.
16218188|NCT01252342|Drug|Saline|10U intramyometrial normal saline bolus immediately after cesarian delivery, and an infusion of 20U/L of oxytocin at 500ml/hr.
16220375|NCT01235494|Other|polarised 3 helium|1 inhalation (= 1 litre)
16218189|NCT01252329|Procedure|elective lymph node dissection|This entails selective lymph node dissection in patients with negative lymph node exams. The nodes dissected are those that drain from the high risk cutaneous squamous cell cancer. Subsequent radiation and/or chemotherapy may be administered in a small percentage of subjects, depending on the result of the neck dissection.
16218190|NCT01252316|Other|CPR Training using the Family and Friends CPR Anytime VSI Kit|Subjects will be trained using the American Heart Association's Family and Friends CPR Anytime Kit. The subject's will undergo training in-hospital then they will be encouraged to take the kit home with them to practice CPR with their family members and friends.
16218191|NCT01252316|Other|Implementation of an In-Hospital CPR Training Model|UPHS Nurses and Volunteers will be trained in our in-hospital CPR Training Model using VSI Kits, and encouraged to implement the training program in their respective hospitals.
16218192|NCT01252303|Behavioral|Nutrisystem|Nutrisystem meal replacements for 12 weeks
16218193|NCT01252290|Drug|Lovaza™|4 capsules daily for 6 months
16218194|NCT01252277|Drug|Lovaza™|4 capsules daily for 6 months
16218195|NCT01252251|Drug|RAD001 (Everolimus) and Pasireotide (SOM230) LAR|Patients will be treated with SOM-230 (pasireotide) LAR 60mg IM once every 28 days and with RAD001 (Everolimus) 10mg PO daily. Each cycle is 28 days. An optional biopsy may be requested required after weeks of therapy. The biopsy may be performed between days 28 and 42.
16218196|NCT01252238|Drug|Aliskiren|Aliskiren 150 mg daily for 10 weeks, force titrated after initial 2 weeks.
16218197|NCT01252238|Drug|Valsartan and Aliskiren|Subject taking combination of valsartan and aliskiren.
16218198|NCT01252238|Drug|Amlodipine|Taking Amlodipine as prescribed by MD for management of high blood pressure.
16218199|NCT01252225|Drug|10 % Lidocaine|600 mg Nebulised Lidocaine ( 6 mls of 10 % Lidocaine) one-off dose
16218200|NCT01252225|Drug|10 % Lidocaine|100 mg Lidocaine ( 1 ml of 10 % Lidocaine) given as one-off throat spray.
16218201|NCT01252225|Drug|0.9% saline|6 mls of 0.9% saline nebulised followed by 1 ml of 0.9% saline as throat spray
16218202|NCT01252212|Behavioral|SMS medication adherence|SMS messages to cell phones.
16218203|NCT01252212|Behavioral|No SMS adherence reminder|In this arm, patients will be sent supportive lifestyle suggestions to their phone using SMS technology but will not be sent a reminder regarding their medication adherence.
16218204|NCT01252199|Drug|cαStx1/cαStx2|cαStx1/cαStx2 administered concomitantly at a dose of 1 mg/kg (low dose cohort) or 3 mg/kg (high dose cohort)per antibody over 1 hour + standard of care
16218205|NCT01252199|Drug|Placebo|Placebo administered over 1 hour + standard of care
16218206|NCT01252186|Drug|91-day Levonorgestrel Oral Contraceptive|91-day treatment consisting of 84 blue combination tablets containing 150 µg LNG/30 µg EE and 7 yellow tablets containing 10 µg EE.
16218207|NCT01252186|Drug|28-day Levonorgestrel Oral Contraceptive|21 combination tablets containing 150 µg LNG/30 µg EE.
16218208|NCT01252186|Drug|28-day Desogestrel Oral Contraceptive|21 combination tablets containing 150 µg DSG/30 µg EE.
16218209|NCT01252160|Drug|QUTENZA|Cutaneous patch
16218210|NCT01252147|Other|No treatment|No treatment (intervention) will be provided in this study
16218211|NCT01252134|Device|Biotrue multipurpose solution|Contact lens care solution
16218212|NCT01252134|Device|Sauflon Synergi multipurpose solution|Contact lens care solution
16218213|NCT01252134|Device|OTE Elements multipurpose solution|Contact lens care solution
16218214|NCT01252134|Device|Silicone hydrogel contact lenses (Acuvue Advance)|Commercially marketed contact lenses
16218215|NCT01252121|Other|Systane Ultra Lubricant Eye Drops|One drop in study eye, one time, during office visit.
16218216|NCT01252121|Other|Hialid 0.1 Artificial Tears Eye Drops|One drop in study eye, one time, during office visit.
16218217|NCT01252121|Other|Unisol 4 Saline Solution|One drop in study eye, one time, during office visit.
16218218|NCT01252108|Drug|SQ109|300 mg SQ109 daily for 14 days
16218219|NCT01252095|Drug|PG545|PG545 Lyophilized Powder for Subcutaneous Injection. Patients will be dosed once weekly until they exhibit disease progression, are discontinued for reasons of tolerability, or the study reaches its defined end-point. This study is a dose escalation study with doses of 25 mg to 500 mg planned.
16218220|NCT01252082|Procedure|Scaling and Rootplaning|All patients in the test group receive scaling and rootplaning under local anesthesia
16218221|NCT01252069|Drug|PGL4001, placebo, drug free period|PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets) during 3 periods each ending with a drug free period until return of menses.
16218222|NCT01252069|Drug|PGL4001, progestin, drug free period|PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of progestin Norethisterone acetate 10mg once daily (oral tablets) during 3 periods each ending with a drug free period until return of menses.
16218223|NCT01252056|Drug|Probucol|250mg,Bid
16218224|NCT01252056|Drug|Probucol and Cilostazol|50-100mg,Bid
16218225|NCT01252030|Device|physical activity monitors|physical activity monitors
16218226|NCT01252030|Other|No physical activity monitors|No physical activity monitors
16218227|NCT01252017|Drug|nilotinib|nilotinib (200mg/tab) 1 tab everyday
16218228|NCT01251991|Drug|Psyllium husks|Oral suspension, oral use, two daily dosages consisting of 5 grams each
16218229|NCT01251991|Dietary Supplement|Isolated soy protein|Oral suspension, oral use, 30 grams once per day
16218230|NCT01251991|Dietary Supplement|Isolated whey protein|Oral suspension, oral use, 30 grams once per day
16218231|NCT01251991|Other|Microcrystalline cellulose|Oral suspension, oral use, two daily dosages consisting of 5 grams each
16218232|NCT01251978|Drug|Ranibizumab 2 mg|intravitreal injections of ranibizumab once a month, times 3.
16218233|NCT01251978|Drug|0.5 mg Ranibizumab|6 intravitreal injections of 0.5 mg Ranibizumab every 2 weeks x 3 months.
16218234|NCT01251965|Drug|Ruxolitinib|"Phase I - Starting dose of 50 mg by mouth twice a day for 28 day cycle.
~Phase II - MTD reached in Phase I."
16218235|NCT01251952|Drug|Denileukin Diftitox (Ontak)|"After receiving their stem cell transplant on Day 0, participants will receive study agent via a 30 minute infusion. Participants will also receive a 30 minute infusion of study agent on Day 21.
~Follow-up visits for clinical assessment, blood draws for routine clinical laboratory studies and for immuno-correlative studies will also take place on days 42, 90, 180 and 360."
16218236|NCT01251939|Device|Near-infrared spectroscopy (NIRS)|Non-invasive monitoring device measures the quantity of reflected light photons as a function of two wavelengths, and determines the spectral absorption of the underlying tissue.
16218237|NCT01251926|Drug|EZN-2208|
16218238|NCT01251926|Drug|Bevacizumab|
16218239|NCT01251887|Dietary Supplement|Linoleic Acid|
16218240|NCT01251887|Dietary Supplement|Docosahexaenoic Acid|
16218241|NCT01251887|Dietary Supplement|Eicosapentaenoic Acid|
16218242|NCT01251874|Drug|Carboplatin|Given IV
16218243|NCT01251874|Other|Fluorothymidine F-18|Correlative studies
16218244|NCT01251874|Other|Laboratory Biomarker Analysis|Correlative studies
16218245|NCT01251874|Other|Pharmacological Study|Correlative studies
16218246|NCT01251874|Procedure|Positron Emission Tomography|Correlative studies
16218247|NCT01251874|Drug|Veliparib|Given PO
16218248|NCT01251861|Drug|Akt Inhibitor MK2206|Given PO
16218249|NCT01251861|Drug|Bicalutamide|Given PO
16218250|NCT01251861|Other|Clinical Observation|Undergo clinical observation
16218251|NCT01251861|Other|Laboratory Biomarker Analysis|Correlative studies
16218252|NCT01251848|Drug|Sitaxentan|Sitaxsentan Tablet, 100 mg, q24h (once daily) for 5 days.
16218253|NCT01251848|Drug|Ritonavir|Ritonavir Capsule, 100 mg, q12h (twice daily) for 5 days (morning dose only on Day 5).
16218254|NCT01251848|Drug|Sitaxsentan|Sitaxsentan Tablet, 100 mg, q24h (once daily) for 5 days
16218255|NCT01251848|Drug|Ritonavir|Ritonavir Capsule, 100 mg, q12h (twice daily) for 5 days
16218256|NCT01251835|Drug|Sitaxsentan alone|Days 1-5: Sitaxsentan tablet, 100 mg, q24 h (once a day)
16218257|NCT01251835|Drug|Sitaxsentan|Days 6-12: Sitaxsentan tablet, 100 mg, q24h (once a day)
16218258|NCT01251835|Drug|Rifampin|Days 6-12: Rifampin capsule, 600 mg, q24h (once a day)
16218259|NCT01251822|Drug|PEG 3350 plus electrolytes|Each sachet of PEG 3350 is dissolved in 125 mL of water. Patients receive two sachets of PEG 3350 plus electrolytes followed by two placebo tablets for the first 14 days, after which dosage adjustment is permitted, according to effect. Each patient is treated for 28 days in total.
16218260|NCT01251822|Drug|Prucalopride|"Patients less than 65 years of age receive a solution containing two sachets of reconstituted placebo followed by two prucalopride 1 mg tablets for 28 days.
~Patients more than 65 years of age receive a solution containing two sachets of reconstituted placebo followed by one prucalopride 1 mg tablet and one placebo tablet for 28 days."
16218261|NCT01251809|Drug|Oncaspar|2000 U/m2 BSA, single infusion
16218262|NCT01251809|Drug|PEG-rASNase|500, 1000 or 1500 U/m2 BSA single infusion
16218263|NCT01251796|Drug|ARQ 197 and Erlotinib|Orally twice daily administration of ARQ197 and orally once daily administration of erlotinib hydrochloride
16218264|NCT01251783|Dietary Supplement|Infant Formula|Only Infant Formula without Lactobacillus, Metlin OR Metlos
16218265|NCT01251783|Dietary Supplement|Exclusively breast milk|Children non randomized which mothers decided to feed them with exclusively breast milk
16218266|NCT01251783|Dietary Supplement|Metlin+metlos+Lactobacillus GG|A prebiotic Agave Derivated Metlin+Metlos (6g/L) + 0.3x107 UFC Lactobacillus GG
16218267|NCT01251783|Dietary Supplement|Metlin + Lactobacillus GG|A prebiotic Agave Derivated Metlin (6g/L) + 0.3x107 UFC Lactobacillus GG
16218268|NCT01251783|Dietary Supplement|Metlos + lactobacillus GG|A prebiotic Agave Derivated Metlos (6g/L) + 0.3x107 UFC Lactobacillus GG
16218269|NCT01251783|Dietary Supplement|Lactobacillus GG|An Infant Formula added with 0.3x107 UFC Lactobacillus GG with no Metlin or Metlos
16218270|NCT01251770|Drug|0.45% NaCl/dextrose 5%|Subjects in this arm will receive 0.45% NaCl/dextrose 5% intravenous (IV) maintenance fluids.Total daily fluid infusion equal to: 80 ml/kg/day for those weighing up to 10 kg, and 1500 ml/m^2 body surface.
16218271|NCT01251770|Drug|0.3% NaCl/dextrose 5%|Drug: 0.3% NaCl/dextrose 5% IV maintenance fluids. Total daily fluid infusion equal to: 80 ml/kg/day for those weighing up to 10 kg, and 1500 ml/m^2 surface.
16218272|NCT01251757|Other|Interactive Voice Recognition (IVR) phone calls|"The IVR intervention consisted of automated phone calls designed to educate participants about their medications and to assist them in refilling their prescriptions. The calls fell into two basic types: simple refill reminders and tardy calls for those who were overdue for a refill. Calls occured monthly and were triggered by dispensing information in the electronic medical record (EMR). Call features included the ability to transfer individuals to Kaiser's automated prescription refill service as well as to care managers. Although the calls were triggered by and focused on use of ACE inhibitors, ARBs and statins, they also included reminders to use aspirin, which is known to also be effective for secondary prevention in this patient population."
16218273|NCT01251757|Other|Educational mailings and follow-up for nonadherence|Participants received bimonthly educational materials by mail. In addition, patients received mailed refill reminder letters and their providers were notified electronically if the patients failed to refill in response to the automated calls. The educational mailings included personalized health information such as the participant's cholesterol and blood pressure readings, as well as tools for improving adherence such as frequently asked questions (FAQs) about their medications, a pocket-sized calendar for tracking refills with pertinent phone numbers and web site information and space for them to write their medical record number and prescription numbers.
16218274|NCT01251744|Procedure|Blood sample|Blood sample at study entry, every two months during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
16218275|NCT01251744|Procedure|Cord blood sample|Cord blood sample taken at the time of delivery.
16218276|NCT01251744|Procedure|Saliva swab|Saliva swab taken at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
16218277|NCT01251744|Procedure|Urine sampling|Approximately 10 mL of urine will be sampled at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
16218278|NCT01251744|Procedure|Vaginal swab|Vaginal swab taken at study entry, every month during pregnancy and one month after pregnancy conclusion.
16218279|NCT01251731|Drug|E5501|Treatment Group 1: 10mg E5501 as a single dose in Treatment Period 1, followed by a single dose of 40mg E5501 in Treatment Period 2, followed by a single dose of 80mg E5501 in Treatment Period 3, followed by a selected dose for the Multiple Dose reatment Period.
16218358|NCT01251172|Procedure|Hematopoietic Stem Cell Mobilization|Undergo standard mobilization
16218280|NCT01251731|Drug|E5501|Treatment Group 2: 40 mg E5501 as a single dose in Treatment Period 1, followed by a single dose of 80mg E5501 in Treatment Period 2, followed by a single dose of 10mg E5501 in Treatment Period 3, followed by a selected dose for the Multiple Dose Treatment Period.
16218281|NCT01251731|Drug|E5501|Treatment Group 3: 80mg E5501 as a single dose in Treatment Period 1, followed by a single dose of 10mg E5501 in Treatment Period 2, followed by a single dose of 40mg E5501 in Treatment Period 3, followed by a selected dose for the Multiple Dose Treatment Period.
16218282|NCT01251731|Drug|E5501|Treatment Group 4: A single dose of matching placebo in each of the three Single Dose Treatment Periods and in the Multiple Dose Treatment Period
16218283|NCT01251718|Drug|donepezil hydrochloride|Initial dose of 3 mg orally once daily. After 1-2 weeks, dosage increased to 5 mg orally once daily. After 4 or more weeks, dosage increased to 10 mg orally once daily for patients with severe dementia of Alzheimer's type. Dose reduced appropriately according to patient's symptoms.
16218284|NCT01251692|Procedure|Surgery|The corneal epithelium was debrided, and laser ablation was performed to a depth of 5 micron with an ablation zone of 7 to 9 mm, using the Technolas 217C Plano Scan excimer laser.
16218285|NCT01251679|Behavioral|Hand washing|hand washing education and material
16218286|NCT01251679|Device|Hand washing and surgical mask|hand washing education and material and paper surgical face masks
16218287|NCT01251666|Other|Colonoscopy|Colonoscopy if at least one of the faecal occult blood tests is positive (blinded to each test result)
16218288|NCT01251653|Drug|Afatinib|Maximum Tolerated Dose of Afatinib in combination with gemcitabine
16218289|NCT01251653|Drug|Afatinib|Maximum Tolerated Dose of Afatinib in combination with gemcitabine
16218290|NCT01251653|Drug|docetaxel|Maximum Tolerated Dose of Afatinib in combination with docetaxel
16218291|NCT01251653|Drug|gemcitabine|Maximum Tolerated Dose of Afatinib in combination with gemcitabine
16218292|NCT01251640|Drug|BAY86-9766+Gemcitabine|Phase I: 40 mg/day (20 mg twice daily), 60 mg/day (30 mg twice daily, 100 mg/day (50 mg bid) dependent on safety/tolerability Phase II: Recommended Phase II dose (RP2D) dependent on the results of the Phase I part of this study Route of administration: Oral, twice daily (bid) in combination with gemcitabine 1000 mg/m2 Intravenous infusion over 30 minutes weekly for seven out of eight weeks (Cycle 1); followed by 1000 mg/m2 Intravenous infusion over 30 minutes weekly for three out of four weeks (Cycle 2 and subsequent)
16218293|NCT01251627|Drug|Decitabine|Decitabine will be administered at a dose of 20 mg/m2 infused over a 1 hour period once daily for 5 consecutive days. The totale amount per course is 100 mg/m2. Cycles will be administered every 4 weeks (1 cycle of 28 days).It is recommented that patients be treated for a minimum of 4 cycles.
16218294|NCT01251614|Biological|Adalimumab|Adalimumab by subcutaneous injection every other week (eow)
16218295|NCT01251614|Drug|Methotrexate|Methotrexate 0.1 mg/kg at Week 0 and up to 0.4 mg/kg per week (maximum dose of 25 mg/week) orally.
16218296|NCT01251614|Biological|Placebo to Adalimumab|A single subcutaneous loading dose at Week 0 followed by eow dosing beginning at Week 1.
16218297|NCT01251614|Drug|Placebo to Methotrexate|Orally once a week
16218298|NCT01251601|Other|Pharmacokinetics|Up to three 12 hour PK sampling sessions, one in the second trimester, one in the third trimester and one post partum
16218299|NCT01251588|Biological|autologous cultured chondrocytes on porcine collagen membrane|Implantation received in the previous MACI00206 study
16218300|NCT01251588|Procedure|Microfracture|Arthroscopic Microfracture treatment received in the previous MACI00206 study
16218301|NCT01251575|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic peripheral blood stem cell transplant
16218302|NCT01251575|Drug|Cyclosporine|Given PO or IV
16218303|NCT01251575|Drug|Fludarabine Phosphate|Given IV
16218304|NCT01251575|Other|Laboratory Biomarker Analysis|Correlative studies
16218305|NCT01251575|Drug|Mycophenolate Mofetil|Given PO
16218306|NCT01251575|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo allogeneic peripheral blood stem cell transplant
16218307|NCT01251575|Drug|Sirolimus|Given PO
16218308|NCT01251575|Radiation|Total-Body Irradiation|Undergo total-body irradiation
16218309|NCT01251562|Drug|Sterile Compound C31510 for Injection|During the treatment period, subjects in each initial dose level cohort will have a single 4-hour IV infusion of C31510 at the assigned dose level of their particular cohort, three times per week for 26 days (on Day 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24 and 26) followed by a 28-day follow up period that will be counted from the first dose given on Day 1. In the absence of unacceptable toxicity or disease progression during the treatment period, those subjects may receive similar 28-day repeat treatment cycles of 3 times per week for up to 1 year, at the discretion of the investigator.
16218310|NCT01251549|Device|ReWalk - a motorized exoskeleton suit|The subject will wear the ReWalk suit and have training sessions for walking with the device
16218311|NCT01251536|Drug|Dose escalation of cetuximab|"Dose, frequency & treatment mode: 400 mg/m2 (loading at day 1) followed by 250 mg/m2 weekly (at day 8 and 15)
~Arm allocation at day 22:
~Patients with skin toxicity grade 0 will follow an increasing dose schedule: on days 22 and 29 they will receive 350 mg/m2 and from day 36 onwards, 500 mg/m2 weekly"
16218312|NCT01251536|Drug|Standard first line treatment with cetuximab + Folfiri|"Dose, frequency & treatment mode: 400 mg/m2 (loading at day 1) followed by 250 mg/m2 weekly (at day 8 and 15)
~Arm allocation at day 22:
~Patients with skin toxicity grade 1-4 or other significant toxicity who are not eligible for dose escalation will continue on the standard dose of cetuximab: 250 mg/m2 weekly."
16218313|NCT01251523|Behavioral|PACE|The first intervention to be tested, Physician Asthma Care Education (PACE), is a rigorously evaluated intervention for physicians that has reached hundreds of clinicians across the U.S. and also has been implemented in the United Kingdom and Australia. The efficacy trial of PACE was supported by the National Heart, Lung and Blood Institute and the effectiveness trial by the Robert Wood Johnson Foundation. PACE is now widely available to clinicians, through, among other channels, the National Asthma Education and Prevention Program (NAEPP). It is designed to enhance physician communication, counseling and therapeutics for assisting the general population of children with asthma.
16218359|NCT01251172|Procedure|In Vitro-Treated Peripheral Blood Stem Cell Transplantation|Undergo in vitro treated autologous peripheral blood stem cell transplant
16218360|NCT01251172|Other|Laboratory Biomarker Analysis|Correlative studies
16218361|NCT01251172|Drug|Melphalan|Given IV
16218314|NCT01251523|Behavioral|PACE Plus|In the PACE PLUS intervention a cultural competence component will be added to the PACE curriculum. The cultural competence component uses mini-lecture, video demonstration (video to be developed as part of this proposal), case studies and self observation tools to present the principles of cultural competence derived from the study of the literature. The component integrates into the skills taught, specific content related to working with African American and Puerto Rican families where a child has asthma.
16218315|NCT01251497|Behavioral|diabetes self-management education|
16218316|NCT01251484|Drug|BIBF1120|Tablet 200 mg twice daily until progression
16218317|NCT01251471|Drug|Escitalopram|10 mg/d; optional 20 mg/d after 2 weeks.
16218318|NCT01251458|Drug|Torisel|Torisel will be administered intravenously as an IV infusion over a 30-minute period in adult clinical studies.
16218319|NCT01251419|Other|Social Proximity and Conversion to Generic Medications|At companies where employees are predominantly union members, we will compare the efficacy of a peer information intervention using a testimonial from a union identified employee to an intervention using a testimonial with no union identification, as well as to a no-testimonial intervention.
16218320|NCT01251406|Drug|Placebo|Daily subcutaneous administration for 8 hours a day for 10 days
16218321|NCT01251406|Drug|rhNRG-1 Dose 1|Daily subcutaneous administration for 8 hours a day for 10 days
16218322|NCT01251406|Drug|rhNRG-1 Dose 2|Daily subcutaneous administration for 8 hours a day for 10 days
16218323|NCT01251393|Drug|Biperiden|Thirty volunteers will take three pills of Biperiden (6mg/day) during two months.
16218324|NCT01251393|Drug|Placebo|Thirty volunteers will take three pills of Placebo (6mg/day) during two months.
16218325|NCT01251380|Biological|Botulinum toxin type A|Intramuscular (IM) injection on day 1 of each treatment cycle.
16218326|NCT01251367|Biological|Botulinum toxin type A|I.M. (intramuscular) injection on day 1 of each treatment cycle.
16218327|NCT01251354|Drug|BN83495|1 tablet of 40 mg, oral, daily until progression or death or unacceptable toxicity develops
16218328|NCT01251341|Behavioral|Cognitive-Based Compassion Training|Eight-week training in compassion meditation, using a protocol developed by Geshe Lobsang Negi, Ph.D. of Emory University
16218329|NCT01251341|Behavioral|Mindful Attention Training|Eight week training in mindful attention, using a protocol developed by B. Alan Wallace, Ph.D.
16218330|NCT01251341|Behavioral|Adult Health Education Curriculum|Eight week training in health and wellness, using a curriculum developed specifically for this study.
16218331|NCT01251328|Procedure|General anaesthesia|general anaesthesia is performed according to the hospitals standard
16218332|NCT01251328|Procedure|Sedation|Sedation is performed according to the hospitals standard
16218333|NCT01251315|Drug|Placebo low dose|This is a prospective randomized controlled pilot study, which will include twenty-four (24) healthy individuals.The first 12 subjects (low dose) will be randomized into three sub groups. The first group will be given a single dose of placebo.
16218334|NCT01251315|Drug|N Acetyl cysteine, 600mg (low dose)|The sub-group of four subjects (low dose) will be given a single dose of 600 mg of N-Acetyl Cysteine (NAC).
16218335|NCT01251315|Drug|Proimmune 200 (FT061452) 3000mg low dose|The sub-group of four subjects (low dose) will be given a single dose of Proimmune 200 (FT061452) 3000mg low dose'
16218336|NCT01251315|Drug|Placebo (high dose)|The second sub set of 12 subjects (high dose) will be randomized into three sub groups. The first group will be given a single dose of placebo.
16218337|NCT01251315|Drug|N Acetyl cysteine, 1200mg (high dose)|N Acetyl cysteine (high dose) N-Acetyl Cysteine(NAC)1200mg (high dose) given as a single dose.
16218338|NCT01251315|Drug|FT061452, 6000mg high dose|Proimmune 200(FT061452) high dose group given 6000 mg as a single dose.
16218339|NCT01251302|Diagnostic Test|Corus CAD (ASGES)|Age/Sex/Gene Expression Score - ASGES
16218340|NCT01251276|Biological|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine given IM (intramuscular) as a single 1.0 mL (10 mcg) challenge dose on Day 1 of the Challenge Dose Study
16218341|NCT01251263|Drug|Estradiol or Placebo|Estradiol 1mg twice daily or placebo starting on the last day of OC and continuing during the HFI (total of 9 doses).
16218342|NCT01251263|Drug|Estradiol or Placebo|Estradiol 1mg will be taken twice daily starting with the last day of pills and the 4 days of the HFI(total of 9 doses)
16218343|NCT01251250|Other|laboratory biomarker analysis|Correlative studies
16218344|NCT01251250|Genetic|western blotting|Correlative studies
16218345|NCT01251250|Genetic|gene expression analysis|Correlative studies
16218346|NCT01251250|Other|pharmacological study|Correlative studies
16218347|NCT01251250|Other|flow cytometry|Correlative studies
16218348|NCT01251250|Genetic|fluorescence in situ hybridization|Correlative studies
16218349|NCT01251250|Biological|azadirachta indica|Given orally
16218350|NCT01251250|Genetic|reverse transcriptase-polymerase chain reaction|Correlative studies
16218351|NCT01251237|Drug|NRL0706|Patients receive 1 litre of NRL0706 solution followed by 0.5 litre of clear liquid during the afternoon/evening prior to colonoscopy. Patients receive 1 litre of 0706 solution followed by 0.5 litre of clear liquid during the morning of colonoscopy.
16218352|NCT01251224|Other|Integrated Pest Management|The IPM intervention will include professional mouse abatement, two HEPA filters, targeted cleaning, education about IPM, and allergen-proof mattress and pillow encasements. The intervention will be delivered at baseline to the IPM Group, and then repeated if recurrent or persistent mouse infestation is present.
16218353|NCT01251224|Other|Education|This group will receive education about mouse IPM.
16218354|NCT01251211|Drug|botulinum toxin type A|BTX A : 5 units/0.2 ml, maximum 300 units will be injected subcutaneous in the painful area ; this will be performed after randomization and within a minimum of 3 months interval depending on the duration of efficacy (maximum 6 months) Saline will be injected in the same volume in the painful area within the same frequency
16218355|NCT01251185|Device|Cardiospec|Non-invasive, low-intensity extracoporeal shockwaves at energy density of 0.99 mJ/mm2. 9 treatment sessions, 20 minutes each, over a period of 9 weeks (3 sessions on weeks 1, 5 and 9).
16218356|NCT01251172|Procedure|Autologous Hematopoietic Stem Cell Transplantation|Undergo in vitro treated autologous peripheral blood stem cell transplant
16218357|NCT01251172|Drug|Gamma-Secretase Inhibitor RO4929097|Given orally
16218362|NCT01251159|Genetic|mutation analysis|
16218366|NCT01251146|Drug|Bisoprolol|Bisoprolol will be administered at a dose of 5 milligram (mg) once daily for 2 weeks. If heart rate is less than or equal to 65 beats per minute (bpm), then the initial dose will be administered for another 2 weeks. If the heart rate remains greater than 65 bpm, then the dose will be further increased to 7.5 mg once daily for 2 weeks. After 2 weeks, if the heart rate is less than or equal to 65 bpm, the increased dose will be administered for another 2 weeks. If the heart rate is still greater than 65 bpm, then the dose will be further increased to 10 mg once daily for 2 weeks. After 2 weeks, if the heart rate is less than or equal to 65 bpm, the increased dose will be administered for another 2 weeks.
16218367|NCT01251146|Drug|Atenolol|Atenolol will be administered at a dose of 50 mg once daily for 2 weeks. If heart rate is less than or equal to 65 bpm, then the initial dose will be administered for another 2 weeks. If the heart rate remains greater than 65 bpm, then the dose will be further increased to 75 mg once daily for 2 weeks. After 2 weeks, if the heart rate is less than or equal to 65 bpm, the increased dose will be administered for another 2 weeks. If the heart rate still greater than 65 bpm, then the dose will be further increased to 100 mg once daily for 2 weeks. After 2 weeks, If the heart rate is less than or equal to 65 bpm, the increased dose will be administered for another 2 weeks.
16218368|NCT01251133|Biological|LBVH0101 (Hib vaccine)|0.5mL
16218369|NCT01251133|Biological|Hiberix™ Vaccine|0.5mL
16218370|NCT01251120|Drug|tocilizumab [RoActemra/Actemra]|8 mg/kg intravenously every 4 weeks plus background DMARDs (including methotrexate)
16218371|NCT01251120|Drug|DMARD|Non-biologic DMARDs (including methotrexate) according to current best practice
16218372|NCT01251107|Drug|Bleomycin|10 mg/m2 IV day 8 during cycles 1 to 8
16218373|NCT01251107|Drug|Etoposide|200 mg/m2 iv on days 1 to 3 during cycles 1 to 4; 100 mg/m2 iv on days 1 to 3 during cycles 5 to 8
16218374|NCT01251107|Drug|Doxorubicin|35 mg/2 iv on day 1 during cycles 1 to 4; 25 mg/m2 iv on day 1 during cycles 5 to 8
16218375|NCT01251107|Drug|Cyclophosphamide|1250 mg/m2 iv on day 1 during cycles 1 to 4; 650 mg/m2 iv on day 1 during cycles 5 to 8
16218376|NCT01251107|Drug|Vincristine|1.4 mg/m2 iv (max 2 mg) on day 8 during cycles 1 to 8
16218377|NCT01251107|Drug|Procarbazine|100 mg/m2 po from day 1 to 7 during cycles 1 to 8
16218378|NCT01251107|Drug|Prednisone|40 mg/m2 po from day 1 to 14 during cycles 1 to 8
16218379|NCT01251107|Drug|Doxorubicin|25 mg/m2 iv on days 1 and 15 in each cycle
16218380|NCT01251107|Drug|Bleomycin|10 mg/m2 iv on days 1 and 15 in each cycle
16218381|NCT01251107|Drug|Vinblastine|6 mg/m2 iv on days 1 and 15 in each cycle
16218382|NCT01251107|Drug|Dacarbazine|375 mg/m2 iv on days 1 and 15 in each cycle
16218383|NCT01251081|Other|extra high volume hemofiltration|extra high volume hemofiltration (85 mL/kg/h, EHVHF)
16218384|NCT01251081|Other|high volume hemofiltration|high volume hemofiltration (50 mL/kg/h, HVHF)
16218385|NCT01251068|Device|near infrared spectroscopy: invos 5100|duration:six hours
16218386|NCT01251068|Device|INVOS 5100|NIRS device used in this study, the optical field includes a volume of tissue approximately 2 cm deep to the surface probe with a 4-mm source-detector distance, and thus, organ-specific monitoring is feasible in small patients. With informed consent, we applied NIRS probes to the forehead and the lower extremity for cerebral (rSO2C) and peripheric (rSO2P) regional oxygen saturation measurements.
16218387|NCT01251068|Device|near infrared spectroscopy device|NIRS device used in this study, the optical field includes a volume of tissue approximately 2 cm deep to the surface probe with a 4-mm source-detector distance, and thus, organ-specific monitoring is feasible in small patients. With informed consent, we applied NIRS probes to the forehead and the lower extremity for cerebral (rSO2C) and peripheric (rSO2P) regional oxygen saturation measurements.
16218388|NCT01251055|Drug|GlyT-1 inhibitor-1|GlyT-1 inhibitor-1(500) 4# BID
16218389|NCT01251055|Drug|Placebo|starch
16218390|NCT01251042|Device|Sangvia|The Sangvia® Blood Salvage System used to collect blood intra-operatively.
16218391|NCT01251029|Drug|N-acetylcysteine|1200 mg orally; 600mg i.v.
16218392|NCT01251029|Drug|Siran (N-acetylcysteine)|
16218393|NCT01251003|Biological|Autologous cord blood|there is no minimum acceptable dose, and the maximum allowable dose will be 10x10(9)cells/kg given IV (in the vein), one time infusion
16218394|NCT01250990|Drug|Niacin|Niacin taken orally for 12 weeks at the highest tolerated dose (up to 6 grams), and at least 2 grams daily and up to the maximum approved dose. Subjects will initiate therapy with Niaspan and will advance to Niacor as tolerated.
16218395|NCT01250990|Other|Placebo|Placebo
16218396|NCT01250977|Drug|Donepezil|
16218397|NCT01250977|Drug|Placebo|
16218398|NCT01250964|Procedure|Lens insertion during cataract surgery|After cataract removal during cataract surgery, a lens needs to be injected into the eye. Both arms are routinely used but different methods for injecting the lens.
16218399|NCT01250951|Drug|Deferasirox|
16218400|NCT01250938|Behavioral|ESI - Community Outreach|This is an individualized caregiver-implemented intervention (ESI-CO) offered in 2 weekly sessions to teach caregivers how to embed strategies to support social communication skills within everyday routines, activities, and places for 3 months. Additionally, families receive 6 months (3 months during weekly home sessions and three months upon the completion of weekly home sessions) of resource support to identify local and community autism programs available for continued intervention and services.
16218401|NCT01250925|Drug|ReNu MultiPlus® MultiPurpose Solution|Contact lens care regimen
16218402|NCT01250925|Drug|OPTI-FREE® RepleniSH®|Contact Lens care regimen
16218403|NCT01250925|Drug|Clear Care®|Contact lens care regimen
16218404|NCT01250912|Drug|123I-metaiodobenzylguanidine|FDA Approved for use in Cancer patients. This use is Off Label. For the imaging study, an activity of 370 MBq (10 mCi) 123I-mIBG (GE Healthcare) will be administered intravenously, and a 10-minute planar image of the anterior thorax (128_128 matrix) will be acquired beginning 15 minutes after tracer injection.
16218405|NCT01250899|Dietary Supplement|Vitamin D|50,000 IU vitamin D3 twice weekly for 5 weeks, followed by 2000 IU daily maintenance supplementation to complete 12 weeks. At the end of the 12-week period, 25(OH)D levels will be checked. If the subject is still deficient, he/she may undergo a second period of supplementation (at the discretion of their provider) to complete a total of 24 weeks. After 24 weeks, we anticipate all subjects will be kept on daily maintenance supplementation by their primary physicians.
16220503|NCT01234584|Procedure|CPK Abutments|implants using CPK Abutments
16218406|NCT01250886|Drug|Lactated Ringer's solution|Lactated Ringer's solution is administered. The volume of fluid administration is calculated by means of Holliday and Segar formula.
16218407|NCT01250886|Drug|Normal saline solution|Normal saline solution is administered. The volume of fluid administration is calculated by means of Holliday and Segar formula.
16218408|NCT01250886|Drug|Acetate Ringer's solution|Acetate Ringer's solution is administered. The volume of fluid administration is calculated by means of Holliday and Segar formula.
16218409|NCT01250873|Drug|LY2216684|po administration
16218410|NCT01250873|Drug|Sertraline|po administration
16218411|NCT01250860|Other|Derotational manual therapy techniques in selected segments in spine|Derotational manual therapy techniques in selected segments of spine in preparation for the exercises according to the DoboMed method.
16218412|NCT01250860|Behavioral|Sham therapy|
16218413|NCT01250847|Drug|Quetiapine(Seroquel-XR) 50~800mg a day|The only ARMS subjects will be given 50~800mg Seroquel-XR once daily for total of 12 weeks.
16218414|NCT01250834|Drug|Atorvastatin|Administered orally.
16218415|NCT01250834|Biological|LY2189265|Administered subcutaneously.
16218416|NCT01250821|Drug|Menopur|"The medication used in this study is the follicle-stimulating hormone highly purified human menopausal gonadotrophin (HP-HMG), Menopur, (Ferring a/s).
~Stimulation with HP-hMG (Menopur) is started on day 2-5 of menstrual bleeding.The HP-hMG starting dose is calculated based on the nomogram predicting the threshold dose. The dose-range is from 75 IU/day to 187.5 IU/day."
16218417|NCT01250808|Drug|Bortezomib/Dexamethasone/Melphalan|"Induction therapy: The treatment will continue for 3-4 cycles and each cycle will be last 21 days.
~Bortezomib 1.3mg/m2, twice weekly for two weeks (days 1, 4, 8, and 11) of each cycle + Dexamethasone 20mg/m2, on days 1-4 of each cycle.
~Bortezomib 1.0mg/m2, twice weekly for two weeks (days 1, 4, 8, and 11) of each cycle + Dexamethasone 20mg/m2, on days 1-4 of each cycle.
~Bortezomib 1.6mg/m2, once weekly for two weeks (days 1, 8) of each cycle + Dexamethasone 20mg/m2, on days 1-4 of each cycle and on days 9-12 of the first and second cycles.
~ASCT therapy:
~Melphalan 200mg/m2 +Bortezomib 1.0mg/m2 for four times. Melphalan 200mg/m2 +Bortezomib 1.0mg/m2 for two times."
16218418|NCT01250795|Biological|HAI-05 Influenza Vaccine|injection, vaccine, twice every 3 weeks
16218419|NCT01250795|Other|Saline|
16218420|NCT01250782|Drug|Glutamine|0.5 g/kg/day of dipeptide N (2)-L-Alanyl-L-Glutamine
16218421|NCT01250782|Drug|Physiological serum|100 mL of physiological serum indistinguishable from active comparator
16218422|NCT01250769|Device|Manual Toothbrush|A standard size manual toothbrush to clean visible tooth surfaces
16218423|NCT01250769|Device|Interproximal Cleaning Device|An electronic device that combines water and air to clean between the teeth
16218424|NCT01250756|Biological|7-pneumococcal conjugate vaccine (7vPnC)|0.5 mL per dose, 4 doses
16218425|NCT01250756|Biological|diphtheria, tetanus, and acellular pertussis vaccine (DTaP)|0.5 mL per dose, 4 doses
16218426|NCT01250756|Biological|DTaP|0.5 mL per dose, 4 doses
16218427|NCT01250743|Dietary Supplement|ascorbic acid (vitamin C)|intravenous vitamin C, 25 to 100 grams, once or twice a week, for five months
16218428|NCT01250730|Drug|PF-02341066|Cohort 1: a 150 mg single dose of PF-02341066 administered as 1 x 50 mg IRT and 1 x 100 mg IRT.
16218429|NCT01250730|Drug|PF-02341066|Cohort 2: a 250 mg single dose of PF-02341066 administered as 1 x 50 mg IRT and 2 x 100 mg IRTs.
16218430|NCT01250730|Drug|PF-02341066|Cohort 3: a 400 mg single dose of PF-02341066 administered as 4 x 100 mg IRTs.
16218431|NCT01250717|Drug|Docetaxel|Given by an IV infusion over 1 hour on day 2 of a three-week cycle
16218432|NCT01250717|Drug|Dexamethasone|Orally 12 hours and 1 hour before docetaxel and again 12 hours after docetaxel
16218433|NCT01250717|Drug|Estramustine|Taken orally three times a day for 5 days for the first part of every three week cycle
16218434|NCT01250717|Drug|Zoladex|Given subcutaneously for 4 doses every three months
16218435|NCT01250717|Drug|Casodex|Taken orally once a day for 6 months
16218436|NCT01250717|Procedure|Radical Prostatectomy|after the chemo and hormonal therapy all patients have a radiacal prostatectomy
16218437|NCT01250691|Other|ward-type ICU|frequency of hospital acquired pneumonia in the ICU
16218438|NCT01250652|Drug|Levocetirizine|20 mg levocetirizine for 5 days
16218439|NCT01250652|Drug|Levocetirizine plus Hydroxyzine|24 patient will receive 15 mg Levocetirizine plus 50 mg Hydroxyzine at bad time for 5 days
16218440|NCT01250600|Behavioral|Home exercise|Daily home exercise for 3 months
16218441|NCT01250587|Drug|PDC31|This study involves the sequential administration of PDC31 to 4 cohorts of patients. The dose will be escalated in the absence of dose-limiting toxicities. PDC31 is to be administered as a 3-hour continuous infusion.
16218442|NCT01250574|Other|CD64 and Procalcitonin|Blood tests taken before and regularly after surgery or other treatment.
16218443|NCT01250574|Other|CD64 and Procalcitonin|Blood tests taken before and regularly after surgery or other treatment.
16218444|NCT01250561|Drug|Gabapentin|gabapentin 300mg/day, titrated up weekly to max tolerated dose or 3600mg/day (whichever is lower), for 4-9 weeks
16218445|NCT01250561|Drug|Valacyclovir|valacyclovir 1000mg three-times daily x 7 days
16218446|NCT01250548|Biological|apremilast|30 mg BID apremilast taken orally for the first 12 weeks followed by responders randomized to either 30 mg BID apremilast (oral) or 30 mg BID placebo (oral) for 8 weeks
16218447|NCT01250548|Other|Placebo|
16218448|NCT01250535|Drug|Warfarin|10 mg, po, single dose on day 7
16218449|NCT01250535|Drug|Placebo|po, once a day, days 1 through 14
16218450|NCT01250535|Drug|Lovastatin|40 mg, po, once a day, days 1 through 14
16218451|NCT01250509|Behavioral|Craving and Lifestyle Management through Mindfulness|A preliminary, novel intervention was developed drawing on components from Mindfulness-Based Stress Reduction (MBSR), Mindfulness-Based Cognitive Therapy (MBCT), and Mindfulness-Based Eating Awareness Training (MB-EAT). The intervention program consisted of nine 2.5-hour classes and one 7-hour silent day of guided meditation practice after class 6.
16218452|NCT01250496|Drug|Aminophylline|75 mg of intravenous aminophylline
16218453|NCT01250496|Drug|Placebo|Matching 0.9 Normal Saline (sterile salt water)administered intravenously.
16218454|NCT01250483|Other|PSA measurement, uroflowmetry, IPSS, transrectal ultrasonography|
16218455|NCT01250470|Other|Laboratory Biomarker Analysis|Correlative studies
16218458|NCT01250457|Drug|topical Timolol|topical Timolol 0.5% solution applied twice daily
16218459|NCT01250444|Other|Inspiratory Muscle Training|Breathing exercises associated to the use of a training device with predetermined pressure load, daily, 30 minutes per day, during eight weeks.
16218460|NCT01250431|Behavioral|EFT (Emotional Freedom Techniques)|10 EFT sessions
16218461|NCT01250418|Drug|Ketamine group|ketamine bolus of 0.25mg/kg followed by an infusion set at 1.5 mcg /kg/min.
16218462|NCT01250405|Drug|Cinacalcet|One sequence receives Cinacalcet 30mg /d for 7 days followed by placebo for 7 days
16218463|NCT01250405|Drug|Placebo|One sequence receives placebo for 7 days followed by Cinacalcet 30mg/d for 7 days
16218464|NCT01250392|Behavioral|The Effect of Active Choice on Nurse Visit Participation|"The goal of this project is to see if active choice will increase an individual's likelihood of participating in a nurse visit.
~The employees in our sample will schedule their nurse visit time slot via e-mail and a health service provider website. The control group will be informed via e-mail of the window of dates during which they can take part in the on-site screening and given instructions for scheduling an appointment. The treatment group, the active choice only arm, will be given the same information as the control group, but they will also be asked to make an appointment immediately, defer the scheduling decision, or decline to receive a screening. The treatment group will also receive email reminders one week before their appointment."
16218465|NCT01250379|Drug|bevacizumab [Avastin]|10 mg/ kg iv every 2 weeks or 15 mg/kg iv every 3 weeks
16218466|NCT01250379|Drug|Chemotherapy|Standard chemotherapy (doublets not allowed)
16218467|NCT01250366|Drug|INX-08189|Capsules, Oral, 9 mg, Once Daily, 7 Days
16218468|NCT01250366|Drug|INX-08189|Capsule, Oral, 25 mg, Once Daily, 7 days
16218469|NCT01250366|Drug|INX-08189|Capsules, Oral, 50 mg, Single Dose, 1 day
16218470|NCT01250366|Drug|INX-08189|Capsules, Oral, 9 mg, Once daily, 6 days
16218471|NCT01250366|Drug|INX-08189|Capsules, Oral, 50 mg, Once daily, 7 days
16218472|NCT01250366|Drug|INX-08189|Capsules, Oral, 9 mg, Once daily, 7 days
16218473|NCT01250366|Drug|INX-08189|Capsules, Oral, 100 mg, Once daily, 7 days
16218474|NCT01250366|Drug|Placebo matching with INX-08189|Capsules, Oral, 0 mg, Once daily, 7 days
16218475|NCT01250366|Drug|Ribavirin|Capsules, Oral, 1000 or 1200 mg daily (delivered in weight-adjusted am/pm divided dose), 7 days
16218476|NCT01250353|Procedure|pterygium surgery|pterygium was removed surgically
16218477|NCT01250340|Drug|Aspirin|100 mg/day for 30 days
16218478|NCT01250340|Drug|Placebo|1 cp day for 30 days
16218479|NCT01250327|Device|Melody|insertion of a pulmonic valved stent
16218480|NCT01250327|Device|bare stent|insertion of a bare metal stent
16218481|NCT01250327|Procedure|Surgery|conventional surgery methode
16218482|NCT01250314|Other|Radiology|Spine radiography, densitometry, evaluation of bone architecture and micro-architecture (computed tomography of lumbar spine and hip and peripheral micro-scanner (XREME SCANCO) at tibia and wrist).
16218483|NCT01250314|Other|Biological, biochemical and genetic samples|"*Serum calcium and phosphore evaluation, bone remodeling markers, 25-hydroxyvitamin D level assessment: Blood samples plasma (5 ml):Creatin, calcemia, phosphoremia, alkaline phosphatase, bone alkaline phosphatase, osteocalcin, CTX, 25 hydroxyvitamin D and parathormone
~Urinary samples :
~Deoxy-pyridinoline, creatinuria Fasting morning urine on a sample Calciuria, creatinuria, cortisoluria Day urine on a sample
~*Assessment of possible determinants of fractures in man
~Blood samples plasma (5 ml):
~Sexual Hormones: Estradiol, Testosterone, SHBG, LH, FSH
~Homocysteine
~IGF1
~Extraction of DNA for a genetic polymorphism study:
~Sample of 10 ml of blood on EDTA for DNA extraction.
~Tested polymorphisms will be: LRP5, CYP19 (Aromatase), COL1A1 (Collagen I),MHTFR, IGF-1,VDR vitamin D receptor
~Globally 20 ml of blood will be taken for each subject. Every biological sample for biochemical dosages and for genetic analysis will be preserved in an anonymous way."
16218484|NCT01250301|Other|De-nicotinised cigarettes + standard treatment|"Participants will receive de-nicotinised cigarettes to use as required for 2 weeks after their quit day. These cigarettes are intended to provide a replacement for the behavioural and sensory aspects of smoking without supplying nicotine.
~Participants will also receive standard NHS Stop Smoking Service treatment. This is a combination of weekly behavioural support and medication (e.g. nicotine replacement therapy/varenicline)."
16218485|NCT01250301|Other|Standard Treatment|Participants will receive standard treatment from the NHS Stop Smoking Service.
16218486|NCT01250288|Other|Personal Health Management System|BHIX and LIPIX are offering novel personal health management system to members of its community. These community members, also referred to as consumers, will include patients & their designated proxies. BHIX's system will allow patients to perform various tasks, including, but not limited to, viewing medications, medical allergies and lab results. LIPIX's system is primarily a mechanism forc consumers/patients to communicate directly with their physician through a secure messaging portal. Healthcare providers of these patients, who are affiliated with BHIX, will also be able to view the data entered by consumers in this personal health management system through the RHIO's health information exchange. Thus, the intervention of a personal health management system is being offered to both groups, however in different forms.
16218487|NCT01250275|Other|traditional canola oil|Participants (10 healthy and 10 with peripheral arterial disease) will be asked to attend a total of 5 consecutive visits (with a minimum of 6 days between visits) in a fasting state where they will be randomly assigned one food item in the form of banana bread containing 50 gm fat from traditional canola oil.
16218488|NCT01250275|Other|high oleic canola oil|Participants (10 healthy and 10 with peripheral arterial disease) will be asked to attend a total of 5 consecutive visits (with a minimum of 6 days between visits) in a fasting state where they will be randomly assigned one food item in the form of banana bread containing 50 gm fat from high oleic canola oil.
16218489|NCT01250275|Other|soybean oil|Participants (10 healthy and 10 with peripheral arterial disease) will be asked to attend a total of 5 consecutive visits (with a minimum of 6 days between visits) in a fasting state where they will be randomly assigned one food item in the form of banana bread containing 50 gm fat from soybean oil.
16218490|NCT01250275|Other|high linoleic safflower oil|Participants (10 healthy and 10 with peripheral arterial disease) will be asked to attend a total of 5 consecutive visits (with a minimum of 6 days between visits) in a fasting state where they will be randomly assigned one food item in the form of banana bread containing 50 gm fat from high linoleic safflower oil.
16218491|NCT01250275|Other|coconut oil|Participants (10 healthy and 10 with peripheral arterial disease) will be asked to attend a total of 5 consecutive visits (with a minimum of 6 days between visits) in a fasting state where they will be randomly assigned one food item in the form of banana bread containing 50 gm fat from coconut oil.
16218492|NCT01250275|Other|traditional canola oil|Participants with peripheral arterial disease (n=25) will be randomized to daily consumption of food items prepared with traditional canola oil for eight weeks.
16218493|NCT01250275|Other|safflower oil|Participants with peripheral arterial disease (n=25) will be randomized to daily consumption of foods prepared with an oil mixture representing the typical western diet
16218494|NCT01250262|Other|normal medical care and follow up|physical activity/ nutrition guidelines will be provided and reviewed with the participant as part of standard care; telephone contact will be made weekly to encourage adherence to the health guidelines
16218495|NCT01250262|Other|Isolated Lumbar Resistance Exercise Program|lumbar extension, two set of 10-15 repetitions, once a week for two weeks; lumbar extension, one set of 10-15 repetitions, three times a week, week 3 to 4 months
16218496|NCT01250262|Other|Total Body Resistance Exercise Program|exercises: leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, calf press and abdominal curl, one set of 10-12 repetitions, three time per week, week one to 4 months
16218497|NCT01250249|Biological|BCG Vaccine IP - Serum Institute of India|0.1 ml for adults and children aged 1 month and over 0.05 ml for infants under 1 month of age
16218498|NCT01250236|Drug|brimonidine 0.1%|brimonidine 0.1% eye drops twice daily
16218499|NCT01250236|Drug|placebo|sodium hyaluronate 1.8mg/ml eye drops twice daily
16218500|NCT01250210|Drug|levonorgestrel and ethinyl estradiol|pregnancy prevention
16218501|NCT01250197|Drug|AR-12286|Ophthalmic Solution
16218502|NCT01250184|Other|Physical therapy|Twelve sessions (3 per week)
16218503|NCT01250184|Drug|Lidocaine injection|blocking the Myofascial trigger point (MTP) with lidocaine injection, unique dose.
16218504|NCT01250184|Other|Lidocaine injection + physical therapy|blocking the Myofascial trigger point (MTP) with lidocaine injection plus a standarized therapeutic exercise program (twelve sessions, 3 per week)
16218505|NCT01250171|Biological|Secukinumab 10 mg/kg|Secukinumab was prepared in a sterile water solution.
16218506|NCT01250171|Biological|Canakinumab 10 mg/kg|Canakinumab was prepared in a sterile water solution.
16218507|NCT01250171|Biological|Placebo|The placebo solution for infusion contained 5% glucose.
16218508|NCT01250158|Device|Liver-PILP kit|"Device: Liver-PILP kit The Liver-PILP kit (three devices) is composed of percutaneous, disposable (single-use), catheter-based devices for targeted, isolated, organ specific (liver), drug delivery and perfusion with high dose drugs.
~The Portal Vein Device (PVD): balloon catheter to occlude the portal vein and allow aspiration through a central lumen for portal veno-venous bypass.
~The Hepatic Artery Device (HAD): balloon catheter to occlude arterial flow to the liver.
~The Vena Cava Device (VCD): catheter based device to isolate and access hepatic outflow to vena cava by creating a closed chamber in vena cava at ostia of the hepatic veins while maintaining central vena cava blood flow from lower extremities to right atrium through reduced central lumen."
16218509|NCT01250145|Drug|LY333334|Transdermal patch
16218510|NCT01250145|Drug|Placebo|Transdermal patch
16218511|NCT01250132|Other|Biological and behavioral explorations|"Blood dosages:
~biochemistry
~pituitary gland
~somatotropic axis
~corticotropic axis
~gonadotropic axis
~thyrotropic axis
~antidiuretic axis
~Questionnaires and scales (quality of life, Vineland Adaptive Behavior Scales (VABS)-II)"
16218512|NCT01250119|Drug|erlotinib [Tarceva]|150 mg daily, orally
16218513|NCT01250106|Dietary Supplement|Lactobacillus reuteri|twice daily
16218514|NCT01250093|Device|acupuncture|
16218515|NCT01250080|Dietary Supplement|Total Parenteral Nutrition with Glutamine|daily glutamine supplement of 0.35 g/kg weight as N2-L-Alanyl-L-Glutamine (0.5 g/kg/d - Dipeptiven Fresenius Kabi España) during five days.
16218516|NCT01250080|Other|Total Parenteral Nutrition without glutamine|The control group received a supplemental volume of the basic TPN solution to achieve an isocaloric an isonitrogenated formula with the study group.
16218517|NCT01250067|Procedure|Motor-related cortical potential (Procedure)|
16218518|NCT01250054|Device|Lotrafilcon B contact lens|Commercially marketed, silicone hydrogel, multifocal contact lens for daily wear use
16218519|NCT01250054|Device|Comfilcon A contact lens|Commercially marketed (Europe), silicone hydrogel, multifocal contact lens for daily wear use
16218520|NCT01250041|Procedure|continuous femoral nerve block|ultrasound guided femoral nerve catheter insertion.
16218521|NCT01250041|Procedure|continuous saphenous nerve block|ultrasound guided saphenous nerve catheter insertion
16218522|NCT01250002|Drug|Placebo|Placebo will receive the same volume of saline infusion.
16218523|NCT01250002|Drug|Lidocaine|Lidocaine administration 1.5 mg/kg bolus followed by a 2 mg/kg/hr infusion via intravenous catheter
16218524|NCT01249989|Behavioral|Sequential MBC Condition|Participants in the sequential condition will increase F/V consumption and decrease Sed behavior (weeks 1-6), then increase physical activity (weeks 7-12). Smartphones are equipped with customized real-time goal thermometers that provide objective feedback on target behaviors (FV, Sed, and PA). At the start of prescription, the FV and Sed goal thermometers are activated. During week 1-2, participants will close 1/3 of the gap between their baseline behaviors and target behaviors. During week 3-4 they will close 2/3 of the gap, and in weeks 5-6 they will achieve 100% of their goals. Participants will maintain these goals for the remainder of the 12-week intervention. At week 7, a real-time PA goal thermometer wirelessly linked to accelerometers will be activated. Similarly, in weeks 7-8 participants will be asked to close 1/3 of the gap between their baseline PA and target, in week 9-10 they will close 2/3 of the gap, and finally they will reach 100% of their PA goal in weeks 11-12.
16218525|NCT01249989|Behavioral|Simultaneous MBC Condition|Simultaneous MBC condition will target FV+, Sed- and PA+ simultaneously. Participants in the simultaneous condition will wear their accelerometers and enter diet and sedentary activity 5 days/week. All 3 goal thermometers will be activated from the outset of prescription. The goal will be to close 1/3 of the gap between their FV, Sed, and PA statuses and the targets in weeks 1-2, close 2/3 of the gap in weeks 3-4, reach their targets in weeks 5-6, and then maintain target level behavior changes for FV, Sed and PA through week 12.
16218751|NCT01248195|Drug|12-week clozapine open-label treatment|12-week clozapine open-label treatment
16218526|NCT01249989|Behavioral|Stress Management|Participants in the stress management control condition target stress, relaxation and sleep. This will serve as an attentional control condition. During the 12-week prescription period, participants will wear accelerometers, log hours slept, enter real-time information about their relaxation exercises and stress, and monitor 3 goal thermometers (sleep, relaxation, stress) to meet behavioral targets. Similarly, their goal is to close 1/3 of the gap between their baseline stress, sleep, and performance of relaxation exercises and the target criterion in weeks 1-2, close 2/3 of the gap in weeks 3-4, reach their targets in weeks 5-6, and then maintain these behavior changes through week 12.
16218527|NCT01249976|Other|blood culture|blood culture
16218528|NCT01249963|Dietary Supplement|T-Diet plus Atémpero|T-Diet plus Atémpero is a complete normocaloric and normoproteic enteral nutrition product for the dietary management of patients with mild acute pancreatitis.
16218529|NCT01249963|Dietary Supplement|AlitraQ (Abbott)|AlitraQ is a nutritional product for patients with impaired gastrointestinal function.For oral or tube nutrition. Enriched with glutamine and arginine.
16218530|NCT01249950|Other|feasibility|feasibility
16218531|NCT01249937|Drug|Ranibizumab|Intra-vitreal injections of 0.5mg/0.05 mL dosage, injected at months 0, 1, and 2. For those requiring additional injections, patients will receive monthly treatment up to a maximum of 6 months total.
16218532|NCT01249937|Drug|Triamcinolone Acetonide|Sub-tenon injection of 40mg/mL dosage at months 0 and 2 with follow up for a total of 6 months.
16218533|NCT01249924|Device|auto-titrated CPAP|Patients will be treated with auto-CPAP preoperatively for 2-3 nights preoperatively and 5 nights postoperatively during their sleep.
16218534|NCT01249924|Device|Control|Patients in this group will receive routine care, undergo sleep study on the third postoperative night and be monitored by a pulse oximeter for oxygen saturation level for 2-3 nights preoperatively and 5 nights postoperatively during their sleep.
16218535|NCT01249911|Dietary Supplement|Lreuteri|L. reuteri DSM 17938 will be given at a dose of 5 drops containing 1x108 colony-forming units (CFU) once time per day in an oil formulation delivered from a drop bottle. In the active study product, freeze-dried L. reuteri is suspended in a mixture of pharmaceutical grade medium chain triglycerides and sunflower oil together with pharmaceutical grade silicon dioxide to give the product the correct rheological properties.
16218536|NCT01249911|Other|Placebo|The placebo consists of an identical formulation except that the L. reuteri is not present
16218537|NCT01249872|Drug|GROUP A : 0 mg MORPHINE-0.1% LEVOBUPIVACAINE|Patients receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose 2 ml of normal saline, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA) of 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
16218538|NCT01249872|Drug|GROUP B : 1 mg MORPHINE- 0.1% LEVOBUPIVACAINE|Patients receive intraoperatively(45 min before the estimated end of the surgery)an epidural bolus dose of 1mg of morphine.Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA) of 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
16218539|NCT01249872|Drug|GROUP C : 2 mg MORPHINE-0.1% LEVOBUPIVACAINE|Patients receive intraoperatively (45 min before the estimated end of the surgery) a bolus dose 2 mg of morphine, epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA) of 0.1% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
16218540|NCT01249872|Drug|GROUP D : 0 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Patients receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 2 ml of normal saline epidurally. Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA) of 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
16218541|NCT01249872|Drug|GROUP E : 1 mg MORPHINE-0.2 % LEVOBUPIVACAINE|Patients receive intra-operatively (45 min before the estimated end of the surgery) a bolus dose of 1mg of morphine, epidurally.Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA) of 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
16218542|NCT01249872|Drug|GROUP F : 2 mg MORPHINE- 0.2% LEVOBUPIVACAINE|Patients receive an epidural bolus dose of 2 mg of morphine intra-operatively (45 min before the estimated end of the surgery).Postoperatively, immediately after extubation, patients receive patient controlled epidural analgesia (PCEA) of 0.2% levobupivacaine (5ml, lockout interval 10min) combined with a continuous epidural infusion of morphine 0.2 mg/h.
16218543|NCT01249846|Drug|PerioChip ®|
16218544|NCT01249833|Drug|Oseltamivir|Oseltamivir 75mg BID for 5 days
16218545|NCT01249820|Drug|anidulafungin 200 mg q48h|Day 1-15: anidulafungin 200 mg q48h IV maintenance dose (8 dosages)
16218546|NCT01249820|Drug|anidulafungin 300 mg q72h|Day 1-13: anidulafungin 300 mg q72h IV maintenance dose (5 dosages)
16218547|NCT01249794|Procedure|non invasive ventilation|continuous positive airways pressure
16218548|NCT01249742|Behavioral|Internet intervention|Our intervention, Sugarsquare, is a secured treatment environment only accessible by patients of the KDCN and members of the treatment team. Sugarsquare consists of two main sections. The first section is a semi-public setting on which adolescents can exchange experiences with their diabetes (care) through a forum and a real time chat-application. All patients and treatment team members can see all messages posted here. The second section consists of patients' individual pages with treatment overview and an application for private interaction with the treatment team. Patients can only access their own individual page; treatment team members can access pages of all patients. Sugarsquare is a secured webpage, accessible only through computers equipped with the right certificate (access device) and by using the appointed username-password combination.
16218549|NCT01249716|Dietary Supplement|individual nutritional therapy|individual nutritional therapy provided by a registered dietician by means of three follow-up home visits
16218550|NCT01249690|Drug|Bortezomib,Pirarubicin,Dexamethasone|Bortezomib:1.3mg/m2,on day 1,4,8 and 11 of each 28 day cycle; Pirarubicin:10mg,on day 1 to 4 of each 28 day cycle; Dexamethasone:20mg,on day 1 to 4 and 8 to 11 of each 28 day cycle; Number of cycles: up to 8 cycles.
16218551|NCT01249690|Drug|Thalidomide,Pirarubicin,Dexamethasone|Thalidomide:200mg/d, everyday; Pirarubicin:10mg,on day 1 to 4 of each 28 day cycle; Dexamethasone:20mg,on day 1 to 4 and 8 to 11 of each 28 day cycle; Number of cycles: up to 8 cycles.
16218552|NCT01249677|Drug|insulin glargine|14 patients with type 2 diabetes on previous metformin therapy were treated with insulin glargine, aimed to normalize fasting glycaemia.
16218553|NCT01249664|Biological|VEGF Trap-Eye (BAY86-5321)|1 intravitreal injection of the experimental drug, followed by monthly re-injections if needed
16218554|NCT01249664|Procedure|No Drug|Sham procedure NOT involving injection of any substance; patient´s eye is anesthetized and a syringe without needle gently pressed on the cornea
16218555|NCT01249651|Drug|esomeprazole 40 mg|esomeprazole 40 mg once daily, 8 weeks
16218556|NCT01249638|Drug|Capecitabine|Capecitabine:2 x 1250 mg/m2 day 1-14 followed by 1 week pause q day 21
16218557|NCT01249638|Drug|Bevacizumab|Bevacizumab: 7.5 mg/kg day 1 q day 21
16218558|NCT01249638|Drug|Capecitabine|Capecitabine: 2 x 800mg/m2 day 1-14 followed by 1 week pause q day 21
16218559|NCT01249638|Drug|Irinotecan|Irinotecan: 200 mg/m2 day 1 , q day 21
16218560|NCT01249638|Drug|Bevacizumab|Bevacizumab: 7.5 mg/kg day 1, q day 21
16218561|NCT01249625|Device|N95 Respirator|Participants in this arm will be asked to wear an N95 respirator for the extent of the 12 week study period.
16218562|NCT01249625|Device|Medical/surgical mask|Participants in this arm will be asked to wear a medical/surgical mask for the extent of the 12 week study period.
16218563|NCT01249612|Other|Thermotherapy|Knee joint icing
16218564|NCT01249612|Other|Thermotherapy|Elbow joint icing
16218565|NCT01249599|Procedure|blood sample analysis|The aim of this prospective single-center study is to evaluate endothelial function, vascular compliance, oxidative stress parameters, quality of life and platelet adhesion in patients with apical ballooning syndrome and age-matched controls.
16218566|NCT01249586|Other|E-learning|A traditional class of blindness prevention plus an additional e-learning material. The e-learning material included a PDF article about blindness prevention. This material was e-mailed one week before the traditional class.
16218567|NCT01249573|Other|fascia therapy or transcutaneous fibrolysis|fascia therapy or transcutaneous fibrolysis as treatment for an acute ankle distortion
16218568|NCT01249547|Drug|axitinib|starting dose of 5 mg twice daily for 4 consecutive weeks without interruption.
16218569|NCT01249534|Other|gastroesophageal cancer surgery|gastroesophageal cancer surgery
16218570|NCT01249521|Drug|AMG386 and bevacizumab|AMG386 10mg/kg qw iv Bevacizumab 7.5mg/kg q3w iv
16218571|NCT01249508|Other|nutrition label|
16218572|NCT01249495|Procedure|Sharp debridement|After use of local anestetics a sharp currette is used to debride slough and nonviable tissue from the ulcer surface until a healthy tissue is seen.
16218573|NCT01249469|Other|skin whitening cosmetic product|Product application: twice a day in the morning and before sleep for 8 weeks; from D1 to D55, but no application on D27 at night/ D28 in the morning and D55 at night/ D56 in the morning before visit. The product is applied on one side of the hand
16218574|NCT01249443|Drug|vorinostat|Given PO
16218575|NCT01249443|Other|diagnostic laboratory biomarker analysis|Correlative studies
16218576|NCT01249443|Other|pharmacological study|Correlative studies
16218577|NCT01249443|Drug|carboplatin|Given IV
16218578|NCT01249443|Drug|paclitaxel|Given IV
16218579|NCT01249430|Drug|Azacitidine|Given IV
16218580|NCT01249430|Drug|Cytarabine|Given IV
16218581|NCT01249430|Drug|Etoposide Phosphate|Given IV
16218582|NCT01249430|Other|Laboratory Biomarker Analysis|Correlative studies
16218583|NCT01249430|Drug|Mitoxantrone Hydrochloride|Given IV
16218584|NCT01249430|Other|Pharmacological Study|Correlative studies
16218585|NCT01249417|Biological|Botulinum toxin type A|I.M. (in the muscle) injection on day 1 of a single treatment cycle.
16218586|NCT01249417|Drug|Placebo|I.M. injection on day 1 of a single treatment cycle.
16218587|NCT01249404|Biological|Botulinum toxin type A|I.M. injection on day 1 (single treatment cycle)
16218588|NCT01249404|Drug|Placebo|I.M. injection on day 1 (single treatment cycle)
16218589|NCT01249391|Device|Splinting|Gutter thermoplastic custom-made splint for nominated joint, to be worn at night-time for consecutive nights for 3 months
16218590|NCT01249378|Other|All subjects receive three sequences of a standard breakfast|"All subjects receive three sequences of a standard breakfast containing :
~10 g non emulsified
~or 40 g non emulsified
~or 40 g finely emulsified of milk fat with stable isotope (13C triglyceride). The administration order is determined by randomized allocation. The wash-out period is three weeks. There are not diet or exercise interventions. Only, one week before and three days after, the subjects consume neither naturally enriched in 13C foods or pre/probiotics. In addition, three days before and three days after each test, the subjects receive dietary instructions"
16218591|NCT01249365|Biological|GSK580299 (Cervarix)|3-dose schedule intramuscularly vaccination
16218592|NCT01249352|Drug|Nimotuzumab|200 mg, IV Weekly IV dose for up to 26 weeks.
16218593|NCT01249352|Drug|Cisplatin|75 mg/m2, IV dose on D1 of each chemotherapy cycle, for 4 cycles, always after nimotuzumab.
16218594|NCT01249352|Drug|Fluorouracil|1,000 mg/m2, IV dose in a 24-hour continuous infusion, from D1 to D4, every chemotherapy cycle, for 4 cycles.
16218595|NCT01249352|Radiation|Radiotherapy|Radiotherapy 50.4 Gy, fractions of 1.8 Gy/day
16218596|NCT01249339|Procedure|Buccal Administration of nicotine|Oral pouch 1g, single dose. One pouch administered over 30 minutes.
16218597|NCT01249339|Procedure|Buccal Administration of nicotine|Oral pouch 1g, single dose. One pouch administered over 30 minutes.
16218598|NCT01249339|Procedure|Buccal Administration of nicotine|Oral pouch 0.5 g, single dose. One pouch administered over 30 minutes.
16218599|NCT01249339|Procedure|Buccal Administration of nicotine|Oral pouch 0.3 g, single dose. One pouch administered over 30 minutes.
16218600|NCT01249326|Other|bariatric surgery|This is a prospective longitudinal study of the effect of bariatric surgery on protein requirements and protein metabolism, and protein supplementation interest, appropriate to the digestive tract changes, for the mass and muscle function
16218601|NCT01249300|Other|No intervention|No intervention
16218602|NCT01249274|Drug|Progesterone|100mgs progesterone twice daily
16218603|NCT01249274|Other|Placebo|Matched placebo pills to be taken twice daily
16218604|NCT01249261|Drug|Risedronate|5 mg/day
16218605|NCT01249261|Drug|Placebo/Risedronate|placebo years 1-5 followed by 5 mg risedronate years 6 & 7 and no drug year 8
16218606|NCT01249248|Device|PD2i Analyzer|Analysis of heart rate variability from a standard digital ECG for 6-12 minutes
16218607|NCT01249235|Procedure|Patch or bandage contact lens|Patients will be given a patch or a bandage contact lens at the conclusion of pterygium excision surgery.
16218608|NCT01249222|Procedure|plasmapheresis|Plasmapheresis was done every 24-48 hours and continues up to five times. Blood samples were collected 30 minutes before and after each session of plasmapheresis to determine sequential changes in plasma levels of IL-1β, IL-6 and TNF-α. During each exchange session a volume of 25-30 ml/kg bodyweight of patient's plasma was exchanged with equal volume of 20% human albumin diluted with normal saline solution. Before and after plasmapheresis, prothrombin time, activated partial thromboplastin time (aPTT), platelet count and serum calcium level were checked. calcium gluconate 10% (10 ml) was administered even if patient had normal serum calcium in order to prevent hypocalcaemia due to administration of citrate. All drugs except for vasopressors were stopped during procedure.
16218609|NCT01249222|Other|plasmapheresis|plasmapheresis 5 times every 24-48 hours. the apheresis volume will be 30 ml/kg.
16218610|NCT01249209|Device|lifestyle advice|
16218611|NCT01249196|Drug|SK-PC-B70M|for dosage
16218612|NCT01249183|Biological|Concomitant administration|1 dose (0.5 mL) of VAXIGRIP and 1 dose (0.5 mL) of REPEVAX in 2 separate injections sites (1 on each arm)
16218613|NCT01249183|Biological|Separate administration|1 dose (0.5 mL) of VAXIGRIP at Day 0 and 1 dose (0.5 mL) of REPEVAX 28 days later
16218614|NCT01249170|Behavioral|First year program|Information on group that underwent new educational program
16218615|NCT01249170|Other|Control comparison|Information from group that did not undergo new first year program
16218616|NCT01249157|Device|Positron Emission Mammography (PEM) and Magnetic Resonance Imaging (MRI)|An additional 5 women will be enrolled at the beginning of the study for training purposes only and will not be included in the assessment of this study. Once the patient has had both breast MRI and PEM, the location of each site of potential breast cancer will be listed for each modality. The location of each abnormality on each imaging examination will be documented. Once the histopathologic evaluation has been performed, the pathology results will be compared to the imaging results for each modality. Furthermore, comparison of the performance of MRI and PEM will then be made with the pathological results as the truth. Comparison of the histology and biomarkers in each lesion detected by each modality will be done in order to determine if these factors affect detection by each modality.
16218617|NCT01249144|Device|Intraocular Lens (IOL)|Device for implantation in the capsular bag of the eye for visual correction of aphakia following cataract surgery.
16218618|NCT01249131|Drug|Cobimetinib|Cobimetinib 20 mg will be given orally as tablet formulation in fasted or fed state, or as capsule formulation in fasted state.
16218619|NCT01249118|Drug|GDC-0973 IV Infusion|IV infusion.
16218620|NCT01249118|Drug|GDC-0973 Oral Capsules|Oral dose.
16218621|NCT01249105|Drug|MK-2206|Taken orally once a week
16218622|NCT01249092|Drug|Pentoxifylline|Patients will take 400mg of pentoxifylline three times daily for a total duration of 6 months.
16218623|NCT01249079|Other|No intervention would be provided in this research|No intervention would be provided in this research,but need to draw blood
16218624|NCT01249040|Procedure|Physical therapy|
16218625|NCT01249040|Procedure|steroid intraarticular injection|
16218626|NCT01249027|Device|XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)|Patients who receive XIENCE V® Everolimus Eluting Coronary Stent System (EECSS)will be invited to participate in the study.
16218627|NCT01249014|Other|Warmed fluids|IV fluids warmed by a Belmont fluid warmer
16218628|NCT01249014|Other|Fluid warmer and warming blanket|Warm are blown into a Bair hugger warming blanket covering the patient
16218629|NCT01249014|Device|Belmont fluid warmer|Belmont fluid warmer used to warm fluids
16218630|NCT01249014|Device|Bair hugger warming blanket|Bair hugger warming blanket laid on body
16218631|NCT01249001|Drug|Oral Aprepitant|Subject will receive an oral suspension containing 125mg of Aprepitant
16218632|NCT01249001|Drug|Aprepitant|Subjects will receive a 125 mg Aprepitant capsule
16218633|NCT01248988|Other|Synflorix™ Data collection|Safety monitoring: recording of adverse events during using diary cards and recording of serious adverse events using the latest version of Korea's Post-Marketing Surveillance Serious Adverse Event Reporting Form.
16218634|NCT01248975|Drug|FP/SAL 250/50mcg BID|FP/SAL 250/50mcg BID
16218635|NCT01248975|Drug|GSK2190915 200mg QD (AM)|GSK2190915 200mg QD (AM)
16218636|NCT01248975|Drug|GSK2190915 100mg QD (AM)|GSK2190915 100mg QD (AM)
16218637|NCT01248975|Drug|Montelukast 10mg QD (PM)|Montelukast 10mg QD (PM)
16218638|NCT01248975|Drug|Placebo tablets (2) (AM)|Placebo tablets (2) (AM)
16218639|NCT01248975|Drug|Placebo capsule (PM)|Placebo capsule (PM)
16218640|NCT01248962|Drug|carboplatin|Carboplatin Standard 30-minute infusion. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg (or famotidine 20mg IV)IV and diphenhydramine 50mg IV before carboplatin infusion.
16218641|NCT01248962|Drug|carboplatin|Extended 3-hour infusion carboplatin. All patients will receive identical chemotherapy premedications including dexamethasone 20mg the night before and morning of infusion, montelukast 10mg once daily for three days prior to carboplatin infusion, and ranitidine 50mg IV (or famotidine 20mg IV) and diphenhydramine 50mg IV before carboplatin infusion.
16218642|NCT01248949|Drug|MEDI3617|Participants will receive MEDI3617 via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons.
16218643|NCT01248949|Drug|Bevacizumab|Participants will receive bevacizumab via IV infusion in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons.
16218644|NCT01248949|Drug|Paclitaxel|Participants will receive paclitaxel via IV infusion in each cycle until unacceptable toxicity, documented disease progression, or other reasons.
16218645|NCT01248949|Drug|Carboplatin|Participants will receive carboplatin via IV infusion in each cycle until unacceptable toxicity, documentation of disease progression, or other reasons.
16218646|NCT01248936|Drug|RO5185426|
16218647|NCT01248923|Drug|ARRY-520, KSP(Eg5) inhibitor; intravenous|Part 1: multiple dose, escalating; Part 2: multiple dose, single schedule.
16218648|NCT01248923|Drug|Bortezomib, proteasome inhibitor; intravenous or subcutaneous|Part 1: standard of care; Part 2: standard of care determined in Part 1.
16218649|NCT01248923|Drug|Dexamethasone, steroid; oral|Part 1: standard of care; Part 2: standard of care determined in Part 1.
16218650|NCT01248923|Drug|Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous|Part 1: standard of care; Part 2: standard of care.
16218651|NCT01248923|Drug|ARRY-520, KSP(Eg5) inhibitor; intravenous|Part 1: multiple dose, escalating
16218652|NCT01248923|Drug|Bortezomib, proteasome inhibitor; intravenous or subcutaneous|Part 1: standard of care
16218653|NCT01248923|Drug|Filgrastim, granulocyte-colony stimulating factor (G-CSF); subcutaneous|Part 1: standard of care
16218654|NCT01248910|Behavioral|Alpine Skiing|
16218655|NCT01248897|Other|This study is non-interventional study, so this section is not applicable.|This study is non-interventional study, so this section is not applicable.
16218656|NCT01248884|Biological|Infanrix hexa™|3 doses, intramuscular into left thigh
16218657|NCT01248884|Biological|Prevenar 13®|3 co-administered doses, intramuscular into right thigh
16218658|NCT01248884|Biological|GSK217744|3 doses, intramuscular into left thigh
16218659|NCT01248871|Drug|procedure:sevoflurane-remifentanil/sufentanil|Active Comparator
16218660|NCT01248871|Drug|volatile agent only during reperfusion|Active Comparator
16218661|NCT01248871|Drug|propofol-remifentanil/sufentanil|Active Comparator
16218662|NCT01248858|Drug|GSK2126458 and GSK1120212|GSK2126458 and GSK1120212 are experimental treatments for patients with cancer.
16218663|NCT01248845|Other|Titration of various level of assistance|Exploration of the effects on diaphragmatic electrical activity (EMG) and on respiratory pattern of various level of assistance delivered by the ventilator in intubated spontaneously breathing patients in pressure support (PS) and in Neurally Adjusted Ventilatory Assist (NAVA) by step by step increasing of the level of assistance. Flow, airway pressure, transesophageal EMG signal and transcutaneous EMG signal will be recorded.
16218664|NCT01248832|Behavioral|Telephone Counseling|"Counseling is conducted in Mandarin, Cantonese, Korean, or Vietnamese by counselors at the Helpline. The protocol used is similar to that proved efficacious. However, to make the counseling culturally appropriate for Asian language speakers, we: capitalizing on first contact, present the Helpline as a credible quit smoking program staffed by experts, avoid the term counseling since it is associated with mental illness, and assume a more authoritative role and directive counseling style. Counseling is proactive (1st call is made by smoker, then subsequent calls are made by the counselor) to help reduce attrition. Counseling includes a 30-40 minute comprehensive pre-quit session plus up to 5 shorter follow-up calls (about 10 minutes) scheduled according to the probability of relapse."
16218665|NCT01248832|Behavioral|Self-Help Materials|All subjects (both in the telephone counseling group and the materials-only group) receive self-help materials in teh appropriate language. Materials were created in-house, are written in the appropriate language, and cover the essentials of the quitting process such as motivation, physiological and emotional responses to quitting, nicotine in the body, quitting aids, quitting strategies (including those that might be culturally specific such as acupuncture or herbs), setting a quit date, planning, relapse prevention, differentiating between slips and relapse, long-term maintenance, and developing the nonsmoker self-image.
16218666|NCT01248819|Drug|Ropivacaine 60 mg|Nebulization grou received intraperitoneal instillation of saline 20 ml on the gall bladder after induction of pneumoperitoneum but before dissection of gall bladder plus intraperitoneal nebulization of ropivacaine 1% 3 ml (30 mg) the start of gall bladder dissection and again at the end of surgery just before deflation of pneumoperitoneum (total of 60 mg). The first ropivacaine nebulization was performed over 5-6 minutes using the Aeroneb Pro® device through the umbilical port while the other ports were being inserted, while second nebulization was performed before the withdrawal of the ports
16218667|NCT01248819|Drug|Ropivacaine 100 mg|Instillation group received intraperitoneal instillation of ropivacaine 0.5%, 20 ml (100 mg) on the gall bladder after induction of pneumoperitoneum but before dissection of gall bladder plus and intraperitoneal nebulization of normal saline 3 ml before the start of gall bladder dissection and again at the end of surgery just before deflation of pneumoperitoneum. The first saline nebulization was performed over 5-6 minutes using the Aeroneb Pro® device through the umbilical port while the other ports were being inserted, while second nebulization was performed before the withdrawal of the ports
16218668|NCT01248806|Radiation|Low dose CT scan|A low dose CT scan of the lungs is performed after the inclusion of the patient in the study and if negative for active disease, a CT scan if performed once per year for whole period of follow-up
16218669|NCT01248793|Drug|Placebo|Placebo subcutaneous (SC) injections at Weeks 0, 4, 8, 12, 16, and 20
16218670|NCT01248793|Drug|Golimumab|Golimumab 50 mg SC injection every 4 weeks for 48 weeks
16218671|NCT01248793|Drug|Golimumab (placebo group)|Golimumab with early escape at Week 16, 50 mg SC injections at Week 24 and every 4 weeks thereafter through Week 48
16218672|NCT01248780|Drug|Golimumab|50 mg subcutaneous (SC) injection every 4 weeks for up to 48 weeks
16218673|NCT01248780|Drug|Placebo|Placebo SC injections at Weeks 0, 4, 8, 12, 16, and Week 20 followed by golimumab 50 mg SC injections at Week 24 and every 4 weeks thereafter up to Week 48.
16218674|NCT01248780|Drug|Methotrexate (MTX)|A stable dose of MTX (oral or injectable) will be administered to participants according to the local prescribing guidelines for up to 48 weeks.
16218675|NCT01248754|Procedure|Surgical neuronavigation with 18F-DOPA PET imaging|Subjects will undergo preoperative 18F-FDOPA PET imaging, which will be used in neuronavigation software to guide resection of their high-grade glioma. Postoperative 18F-FDOPA PET imaging will be obtained to determine the extent of resection.
16218676|NCT01248741|Radiation|HDR prostate brachytherapy|"HDR prostate brachytherapy to be delivered in 2 fractions of 10 Gray as a boost combined with external beam radiotherapy"
16218677|NCT01248728|Dietary Supplement|Omega-3 Fatty Acids|Children will be administered 3.75ml of the liquid formulation of Nutra Sea HP (containing 1.5 gr of EPA+DHA). The starting dose will be 1.875ml (0.75 gr of EPA+DHA) and the dose will be doubled on week 2. The parents may choose to give this as a single dose or split it to two doses if stomach upset occurs. This formulation is double distilled and has very little fishy taste, which will make it more palatable for children and will make creating a matching placebo a simpler process.
16218752|NCT01248195|Behavioral|Psychosocial intervention|Psychosocial intervention
16218753|NCT01248143|Dietary Supplement|Green tea|9 gram per day
16218678|NCT01248728|Dietary Supplement|Placebo|Children will be administered 3.75ml of the liquid formulation of Placebo. The starting dose will be 1.875ml and the dose will be doubled on week 2. The parents may choose to give this as a single dose or split it to two doses if stomach upset occurs. This formulation is double distilled and has very little fishy taste, which will make it more palatable for children and will make creating a matching placebo a simpler process.
16218679|NCT01248715|Drug|oseltamivir|These patients will receive early (within 8-12 hours of admission, no later than 24 hours after admission) oseltamivir plus current, standard empiric antibacterial therapy based on national recommendations from the IDSA/ATS guidelines for management of hospitalized patients with CAP (2). Anti-influenza therapy will be given using oseltamivir at a dose of 75 mg twice daily. The oseltamivir dose will be adjusted in patients with renal insufficiency according to the package insert. Duration of antiviral therapy will be for a minimum of 5 days for patients with evidence of early clinical improvement and prolonged depending on clinical stability
16218680|NCT01248702|Other|Use of the ICD Critical Pathway|The critical pathway is a series of predetermined processes designed to assess a patient's eligibility for an ICD. The critical pathway will incorporate current evidence-based practice guidelines.
16218681|NCT01248689|Other|concentration profile 1|"IOP will be measured under this order of sevoflurane concentrations:
~7%, 5%, 2%, 0.5%"
16218682|NCT01248689|Other|concentration profile 2|"IOP will be measured under this order of sevoflurane concentrations:
~7%, 2%, 5%, 0.5%"
16218683|NCT01248689|Other|concentration profile 3|"IOP will be measured under this order of sevoflurane concentrations:
~7%, 0.5%, 5%, 2%"
16218684|NCT01248676|Other|Multi-language Online Patient Education Module in addition to standard Patient Teaching|"Patients are usually be given a 5-10 minute new patient teaching before their radiation therapy simulation and planning appointment and before their first radiation therapy treatment appointment. Patients will be asked to view an online patient education module before their radiation therapy simulation and planning appointment or before their first radiation therapy treatment appointment. Then patients will be asked to participate in an interview session and fill out a survey (attached). They will still receive new patient teaching from the therapists before their radiation therapy simulation and planning or radiation therapy treatment appointment."
16218685|NCT01248663|Procedure|antecolic reconstruction|see study arm description
16218686|NCT01248663|Procedure|retrocolic reconstruction|see study arm description
16218687|NCT01248650|Drug|nalfurafine hydrochloride|
16218688|NCT01248637|Drug|Pimonidazole hydrochloride|Pimonidazole is a 2-nitroimidazole that is selectively reduced and covalently binds to intracellular macromolecules in areas of hypoxia (by definition, p02 <= 10mm Hg) within normal and tumour tissue. Pimonidazole adducts can then be detected by immunolabelling techniques (microscopy, ELISA, flow cytometry etc). In this study, pimonidazole will be administered orally as a one time dose of 0.5gm/m2 24hrs prior to surgery. Since the drug has a half-life of approximately 5 hrs, this time-frame ensures low circulating levels at the time of surgery and therefore reduces the confounding effects of surgical hypoxia on tumour analysis.
16218689|NCT01248624|Behavioral|Early Palliative Care Referral|The intervention arm receives early referral to and follow-up by a symptom control and palliative care team at Princess Margaret Hospital.
16218690|NCT01248611|Drug|fentanyl|nasally, dose titrated to effect
16218691|NCT01248585|Drug|Dexamethasone|2 x 4 mg dexamethasone (dex) tablets taken once daily for 5 days
16218692|NCT01248585|Drug|Placebo|2 placebo tablets taken once daily for 5 days
16218693|NCT01248572|Device|Softec HD IOL|Posterior chamber intraocular lens intended for the replacement of the human crystalline lens following phacoemulsification cataract removal in adults over the age of 21.
16218694|NCT01248546|Procedure|Digital breast tomosynthesis|The participants included in the trial will have an additional radiation exposure for breast tomosynthesis
16218695|NCT01248520|Other|influenza and general health information|Subjects assigned to the influenza information group will receive health text messages from the time they enroll until they deliver. These messages will contain general health information as well as information regarding influenza and the importance of vaccination during pregnancy.
16218696|NCT01248520|Other|general health information|Subjects assigned to the influenza information group will receive health text messages from the time they enroll until they deliver.
16218697|NCT01248494|Drug|BEZ235|"Dose level 1: 400mg PO BID
~Dose level -1: 400mg PO in AM and 200mg PO in PM
~Dose level -2: 200mg PO BID"
16218698|NCT01248494|Drug|BKM 120|"Dose Level 1: BKM120, 100 mg PO daily
~Dose level -1: BKM120, 80 mg PO daily
~Dose Level -2: BKM120, 60 mg PO daily"
16218699|NCT01248494|Drug|Letrozole|All levels: 2.5mg/day PO
16218700|NCT01248494|Drug|BKM120|"Dose Level 1: BKM120, 100 mg PO from Mondays through Fridays, weekly
~Dose level -1: BKM120, 80 mg PO from Mondays through Fridays, weekly
~Dose Level -2: BKM120, 60 mg PO from Mondays through Fridays, weekly"
16218701|NCT01248481|Drug|Acarbose (Glucobay, BAYG5421)|Adult female and male patients are scheduled to be treated with acarbose will be enrolled after the therapy decision has been made. Physicians should consult the full prescribing information for Glucobay® before enrolling patients and familiarize themselves with the safety information in the product package label.
16218702|NCT01248468|Drug|Aspirin, acetaminophen and caffeine|2 tablets each containing Aspirin (250mg), acetaminophen (250mg) and caffeine (65mg)
16218703|NCT01248468|Drug|Sumatriptan|100 mg Sumatriptan
16218704|NCT01248468|Drug|Placebo|placebo
16218705|NCT01248455|Drug|(Anti-KIR)|Patients will receive anti-KIR(IPH2101) (1mg/kg) every other month for 6 cycles
16218706|NCT01248442|Drug|Cholecalciferol|monthly dose of 140.000 IU of cholecalciferol orally, 3 times.
16218707|NCT01248442|Drug|Placebo|Matching Placebo
16218708|NCT01248429|Biological|CPK dosage|CPK dosage during a blood sample realized at least one week after the begining of the treatment
16218709|NCT01248429|Other|Clinical exam|Examination of the patient for myalgia, cramps, medical history and concomitant medication
16218710|NCT01248416|Drug|Aromatase Inhibitor|
16218711|NCT01248416|Drug|Growth Hormone|
16218712|NCT01248416|Drug|Aromatase Inhibitor and Growth Hormone|
16218713|NCT01248403|Drug|Paclitaxel|Paclitaxel 80 mg/m2 on day 1, day 8 and day 15 of every 28-day cycle.
16218714|NCT01248403|Drug|RAD001|RAD001 10mg (2 x5 mg tablets / day) d1-d28
16218754|NCT01248143|Dietary Supplement|FPP|2 sachets twice daily
16218715|NCT01248390|Behavioral|Interactive metronome|A randomized, controlled investigation into the effects of IM training on a sample of boys with attention deficit disorder showed positive results. Compared to an active control treatment, IM training improved performance on a host of measures, including attention, motor control, language processing, reading, and parental reports of improvements in the regulation of aggressive behavior.16 It should be noted that these cognitive and behavioral functions are common symptom areas in individuals surviving TBI and are likely to be especially affected in cases of blast injury
16218716|NCT01248377|Procedure|Skin tests and ELISPOT assay|Patch test and/or intradermal test will be performed in patients as well as cytokine secretions from PBMCs will be analyzed by ELISPOT assay
16218717|NCT01248364|Drug|BI 10773|BI 10773 tablets once daily high dose
16218718|NCT01248351|Other|autologous stored platelets|Administration of autologous stored platelets
16218719|NCT01248351|Other|administration of autologous stored platelets|administration of autologous stored platelets
16218720|NCT01248351|Biological|autologous stored platelets|transfusion of autologous stored platelets
16218721|NCT01248338|Drug|metoprolol succinate|once daily 50 or 100 mg for one year
16218722|NCT01248338|Drug|Nebivolol|once daily 5 mg capsule for one year
16218723|NCT01248325|Drug|Luffa Operculate Nasal Solution 5mg/mL|The treatment will start on the first visit in which subjects will be instructed to instill in the nasal passages, 3 drops of the product by morning and 3 drops of the product at night.
16218724|NCT01248325|Drug|Saline Solution (NaCl 0,9%)|The treatment will start on the first visit in which subjects will be instructed to instill in the nasal passages, 3 drops of the product by morning and 3 drops of the product at night.
16218725|NCT01248312|Device|Sentec monitoring device|Sentec monitor applied transcutaneously to forehead
16218726|NCT01248312|Device|sentec monitor|transcutaneous monitoring
16218727|NCT01248299|Drug|FU-CDDP|"every 21 days:
~Fluoro-uracil [800 mg/m2, day 1 to day 5]
~CisPlatin [75 mg/m2, day 1 or day 2]"
16218728|NCT01248299|Drug|LV5FU2-CDDP|"every 14 days:
~Elvorin [200 mg/m2, 2h IV, day 1 and day 2]
~Fluoro-uracil [400 mg/m2 as a bolus, day 1 and day 2]
~Fluoro-uracil [600 mg/m2, 22h continous infusion, day 1 and day 2]
~CisPlatin [50 mg/m2, day 2]"
16218729|NCT01248299|Drug|FOLFOX|"every 14 days:
~Oxaliplatin [85 mg/m2 by 2h infusion, day 1]
~Fluoro-uracil [400 mg/m2 as a bolus, day 1 and day 2]
~Fluoro-uracil [600 mg/m2, by 22h continous infusion, day 1 and day 2]
~Elvorin [500 mg/m2, day 1 and day 2]"
16218730|NCT01248299|Drug|TPF|"every 21 days:
~Docetaxel [30 mg/m2, day 1 and day 8]
~CisPlatin [60 mg/m2, day 1]
~Fluoro-uracil [200 mg/m2/day by continous infusion]
~Or every 21 days:
~Docetaxel [50 mg/m2, day 1]
~CisPlatine [70 mg/m2, day 1]
~Fluoro-uracile [700 mg/m2 /day, day 1 to day 5]"
16218731|NCT01248299|Other|Best Supportive Care|See European professionnal recommendations (ESMO 2009) Exemples : antalgic treatment, nutritional support, ...
16218732|NCT01248286|Other|Whole grain rice|Whole grain rice arm (treatment arm): Subjects will be provided a supply of whole grain rice and will be asked to prepare rice items in their meal with the provided whole grain rice while participating in the study
16218733|NCT01248286|Other|Refined grain rice|Refined grain rice arm (control arm): Subjects will be provided a supply of refined grain rice and will be asked to prepare rice items in their meal with the provided refined grain rice while participating in the study
16218734|NCT01248273|Biological|Globo-H-GM2-sTn-TF-Tn-KLH conjugate, plus the immunological adjuvant QS-21|The injection will be administered subcutaneously during weeks 1, 2, 3, 7 and 19, totaling five injections over the course of the study. Three dose levels are planned: 25 mcg, 50 mcg and 100 mcg. We plan to vaccinate six patients at each dose level unless 2 dose limiting toxicities are observed, and an expansion cohort of 6 patients will be enrolled at the highest dose level achieved.
16218735|NCT01248260|Dietary Supplement|Folic Acid|4mg of higher strength folic acid once a day until delivery
16218736|NCT01248247|Drug|Erlotinib|150 mg by mouth each day of a 28 day cycle.
16218737|NCT01248247|Drug|AZD6244|100 mg by mouth daily of a 28 day cycle.
16218738|NCT01248247|Drug|MK-2206|100 mg by mouth every week of a 28 day cycle.
16218739|NCT01248247|Drug|Sorafenib|400 mg by mouth twice a day for a 28 day cycle.
16218740|NCT01248247|Drug|Erlotinib|150 mg by mouth daily of a 28 day cycle.
16218741|NCT01248247|Drug|MK-2206|135 mg by mouth every week of a 28 day cycle.
16218742|NCT01248234|Drug|propofol|Propofol 1mg/kg will be given once to put the patient to sleep for surgery.
16218743|NCT01248234|Drug|Etomidate|Etomidate 0.3mg/kg will be given once to put the patient to sleep for surgery.
16218744|NCT01248234|Drug|Propofol and Etomidate|Etomidate 0.2mg/kg plus Propofol 0.5mg/kg will be given once to put the patient to sleep for surgery.
16218745|NCT01248221|Drug|[13C]-Spirulina platensis and 99mTc sulfur colloid|The subject will consume the test meal containing 13C-Spirulina and 99mTc sulfur colloid in no more than 10 minutes. Scintigraphic image acquisition will be obtained upon completion of the meal and at 15, 30, 45, 60, 90, 120, 150, 180, and 240 minute time points. Breath samples will be collected at baseline before the test meal is started and thereafter on the same time schedule as the scintigraphic procedure.
16218746|NCT01248208|Biological|FluMist intranasal influenza vaccine|FluMist intranasal vaccine 0.2 mL will be given 0.1 mL in each nostril per manufacturer's instructions.
16218747|NCT01248208|Biological|"Intramuscular influenza injection (flu shot)"|"Subjects < 2 years or > 49 years or those with asthma symptoms or treatment within the past year will receive the intramuscular flu shot in a single injection.
~Age 6-36 months: 0.25 mL IM x 1; Age >36 months: 0.5 mL IM x 1 Boosters: All children aged 6 months-8 years who receive a seasonal influenza vaccine for the first time should be administered 2 doses. Children aged 6 months-8 years who received a seasonal vaccine for the first time during 2009-2010 but who received only 1 dose should receive 2 doses, rather than 1, during 2010-2011. In addition, for the 2010-11 influenza season, children aged 6 months-8 years who did not receive at least 1 dose of an influenza A (H1N1) 2009 monovalent vaccine should receive 2 doses of a 2010-11 seasonal influenza vaccine, regardless of previous influenza vaccination history. For all children, the second dose of a recommended 2-dose series should be administered 4 or more weeks after the initial dose."
16218748|NCT01248195|Drug|Amisulpride open label|4-week open label amisulpride treatment
16218749|NCT01248195|Drug|6-week amisulpride double blind treatment|6-week amisulpride double blind treatment
16218750|NCT01248195|Drug|6-week olanzapine double blind treatment|6-week olanzapine double blind treatment
16218755|NCT01248130|Drug|Omega-3 Fatty Acid|Children with Autism Spectrum Disorders will be randomized to receive either 1500mg (3 capsules) omega-3 fatty acids or placebo. Each 500mg capsule contains 350mg EPA and 50mg DHA. Omega-3 fatty acids dosing will be on a forced titration schedule to 3 capsules per day. All subjects will start with 1 capsule per day with an increase to 3 capsules per day by week 2. Subjects will be maintained at 3 capsules per day thereafter until the end of the trial (completion/discontinuation). During the 12 weeks of the study period, participants will be evaluated at weekly intervals during the first three weeks of the trial (baseline, weeks 1-3) and tri-weekly thereafter till the end of the trial (weeks 6, 9 and 12). At each visit, measures of safety and effectiveness will be administered and subjects will be evaluated for response and side effects to the treatment. Study medications will be prescribed under double blind conditions.
16218756|NCT01248117|Drug|ranibizumab 2.0mg|Monthly, intravitreal injection 0.05ml
16218757|NCT01248104|Drug|Tranexamic Acid|Infusion during cardiac surgery
16218758|NCT01248104|Drug|Aminocaproic Acid|Infusion during cardiac surgery
16218759|NCT01248091|Procedure|Nitroprusside Gel|10 cc nitroprusside gel
16218760|NCT01248091|Procedure|Placebo Gel|half of the subjects will receive nitroprusside gel for IUD insertion and the other half will receive a placebo gel.
16218761|NCT01248078|Drug|Keflex|2g of i.v. cefazolin singleshot administered before skin incision
16218762|NCT01248078|Drug|Keflex|2g of i.v. cefazolin singleshot administered after umbilical cord clamping
16218763|NCT01248078|Drug|saline solution|100cc administered before skin incision
16218764|NCT01248065|Drug|Vitamin D3|vitamin D (100,000 IU loading dose followed by 4,000 IU/day)
16218765|NCT01248065|Drug|Ciclesonide|Low dose inhaled corticosteroid (80 mcg/puff two puffs twice daily)
16218766|NCT01248052|Drug|LY2979165|administered orally
16218767|NCT01248052|Drug|Placebo|administered orally
16218768|NCT01248026|Other|Buttermilk|"Consumption of the 2 experimental periods
~buttermilk (45 g/d)
~placebo (45 g/d,)"
16218769|NCT01248013|Behavioral|gut focused hypnotherapy|7 session hypnotherapy protocol designed for irritable bowel syndrome
16218770|NCT01248000|Procedure|FDG-PET|PET interpretation is based on a site-to-site comparison of FDG uptake both before and after chemotherapy (qualitative approach), according to the criteria defined by Cheson (2008)
16218771|NCT01247987|Procedure|Blastocyst cryopreservation|Embryos cryopreserved at the blastocyst stage
16218772|NCT01247987|Procedure|Bipronuclear oocyte cryopreservation|Bipronuclear oocyte cryopreservation.
16218773|NCT01247974|Device|CorMatrix ECM for Pericardial Closure|Circumferential closure of the pericardium following CABG surgery using the CorMatrix ECM for Pericardial Closure
16218774|NCT01247961|Drug|Dexamethasone acetate|10 mg intravenous given as single administration with optional repeat dose after 36 hours.
16218775|NCT01247961|Other|Placebo|Normal saline
16218776|NCT01247948|Procedure|navigation assisted spine surgery|navigation assisted pedicle screw placement of spine surgery
16218777|NCT01247948|Procedure|traditional spine surgery|traditional spine surgery without navigation assist
16218778|NCT01247935|Other|Acupuncture|Electrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy
16218779|NCT01247935|Other|Transcutaneous electrical stimulation|Electrostimulation at 5 Hz in GI4, ST36, MP6, MP9 starting 20 minutes before colonoscopy
16218780|NCT01247935|Other|Control|Patients are monitored for pain and discomfort
16218781|NCT01247922|Drug|Erlotinib|continuous oral Erlotinib 85 mg/m^2 per day
16218782|NCT01247909|Drug|Ceftriaxone v penicillin and gentamicin|Ceftriaxone v the standard treatment of infant meningitis (penicillin and gentamicin). Ceftriaxone will be given at a dose of 80mg/kg once a day for at least 14 days.
16218783|NCT01247896|Drug|PF-05190457|Single Dose 2 mg
16218784|NCT01247896|Drug|PF-05190457|Single Dose 10 mg
16218785|NCT01247896|Drug|PF-05190457|Single Dose 30 mg
16218786|NCT01247896|Drug|PF-05190457|Single Dose 100 mg
16218787|NCT01247896|Drug|PF-05190457|Single Dose 300 mg
16218788|NCT01247896|Drug|PF-05190457|Single Dose 600 mg
16218789|NCT01247896|Drug|PF-05190457|Single Dose - to be determined with food
16218790|NCT01247896|Drug|PF-05190457|Single Dose - to be determined
16218791|NCT01247896|Drug|Placebo|Single Dose Placebo
16218792|NCT01247883|Drug|PF-04634817|single dose, 20mg, tablet
16218793|NCT01247883|Drug|PF-04634817|single dose, 20mg, solution
16218794|NCT01247870|Drug|Metformin|Metformin 1 g twice daily for 28-35 days
16218795|NCT01247870|Drug|Placebo|Placebo
16218796|NCT01247857|Drug|Ropivacaine 30 mg|"Intraperitoneal nebulization of ropivacaine 1% 3 ml (30 mg) before surgery and intraperitoneal nebulization of normal saline 3 ml after surgery.
~Nebulization was performed over 5-10 minutes using the Aeroneb Pro® device through the umbilical port during the insertion of the other ports, while postoperative nebulization was performed before the withdrawal of the ports."
16218797|NCT01247857|Drug|Ropivacaine 30 mg|"intraperitoneal Nebulization of normal saline 3 ml before surgery and intraperitoneal nebulization of ropivacaine 1% 3 ml (30 mg) after surgery.
~Nebulization was performed over 5-10 minutes using the Aeroneb Pro® device through the umbilical port during the insertion of the other ports, while postoperative nebulization was performed before the withdrawal of the ports."
16218798|NCT01247857|Drug|Saline|Intraperitoneal nebulization of normal saline 3 ml before and after surgery. Nebulization was performed over 5-10 minutes using the Aeroneb Pro® device through the umbilical port during the insertion of the other ports, while postoperative nebulization was performed before the withdrawal of the ports.
16218799|NCT01247844|Device|Shang Ring|The Shang Ring is a sterile device consisting of two concentric medical grade plastic rings: an inner ring with a silicone band and an outer, hinged ring. The inner ring fits inside the outer ring which will lock when snapped together. The Shang Ring comes in multiple sizes. The appropriate size is determined through use of a measuring strip. The man must return to the clinic for device removal. To remove the device, the outer ring locking mechanism is broken open using a tool that is similar to a scalpel handle. Then, a pair of special scissors, specifically designed for this purpose, is used to remove the inner ring after healing
16218800|NCT01247831|Procedure|Selective Laser Trabeculoplasty|100 spots with an energy of 0,8 mJ are applied over 360° of the trabecular meshwork of glaucoma patients with a Q-switched 532 nm frequency doubled neodymium YAG Laser.
16218801|NCT01247818|Drug|PH-10 (0.002% Rose Bengal)|PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
16218802|NCT01247818|Drug|PH-10 (0.005% Rose Bengal)|PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
16218803|NCT01247818|Drug|PH-10 (0.01% Rose Bengal)|PH-10 will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
16218804|NCT01247818|Drug|Vehicle|PH-10 vehicle will be applied daily for 28 days to skin areas affected by mild to moderate psoriasis.
16218805|NCT01247805|Drug|sildenafil citrate|Single oral dose of 1 x 20 mg IR oral tablet.
16218806|NCT01247805|Drug|Sildenafil citrate|single oral dose of 2 x 10 mg sildenafil citrate IR oral tablet.
16218807|NCT01247805|Drug|sildenafil citrate|single oral dose of 2 mL of the 10 mg/mL sildenafil citrate POS (20 mg dose).
16218808|NCT01247792|Behavioral|SOPs for decision-making and communication|Development and implementation of SOPs for timely and interdisciplinary EOL-decisionmaking and a communication strategy with relatives which addresses participants, set-up, time-points, and content
16218809|NCT01247779|Procedure|gynecologic surgery - standard coelioscopy|lymphadenectomy; hysterectomy; nerve sparing; enlarged trachelectomy; omentectomy; appendicectomy; pelvectomy
16218810|NCT01247779|Procedure|gynecologic surgery - robot assisted coelioscopy|lymphadenectomy; hysterectomy; nerve sparing; enlarged trachelectomy; omentectomy; appendicectomy; pelvectomy
16218811|NCT01247753|Behavioral|Walking group|Internet-mediated pedometer-based walking program with gradually increasing step count goals and feedback on step counts. Also includes nutritional coaching course consisting of 1 individual session with a dietician, 4 group sessions, and monthly follow-up. Oral glucose tolerance tests pre and post-intervention.
16218812|NCT01247740|Drug|NuTRIflex Lipid peri|parenteral nutrition
16218813|NCT01247740|Drug|compounded monobag|parenteral nutrition
16218814|NCT01247714|Dietary Supplement|T-Diet plus Standard|T-Diet plus Standard is a complete balanced protein and energy oral nutrition supplement, indicated for the dietary management of patients with related malnutrition.
16218815|NCT01247714|Dietary Supplement|T-Diet plus Diabet NP|T-Diet plus Diabet NP is a complete balanced oral nutrition supplement, indicated for the dietary management of diabetic patients or hyperglycemia related malnutrition.
16218816|NCT01247714|Dietary Supplement|Glucerna|GLUCERNA 1.0 CAL is a reduced-carbohydrate, modified-fat, fiber-containing formula clinically shown to blunt blood-glucose response in patients with abnormal glucose tolerance.
16218817|NCT01247714|Dietary Supplement|Novasource|Complete high protein diet for diabetic patients and hyperglycemic
16218818|NCT01247701|Drug|Busulfan|Busulfan dosing will be as follows: Patients < 12 kg: 1.1 mg/kg/dose IV every 6 hours for 16 doses total; patients > 12 kg: 0.8 mg/kg/dose IV every 6 hours for 16 doses. It will be given on Days -9, -8, -7 and -6.
16218819|NCT01247701|Drug|Cyclophosphamide|Cyclophosphamide (50 mg/kg/dose) will be given IV on Days -5, - 4, -3, and -2 over 2 hours. The total dose to be given over 4 days is 200 mg/kg.
16218820|NCT01247701|Drug|Fludarabine|Fludarabine 40 mg/m^2 will be given IV daily over 1 hour on Days -3, -2 and -1.
16218821|NCT01247701|Procedure|Cord Blood Stem Cell Infusion|The cord blood stem cells will be infused on Day 0.
16218822|NCT01247688|Drug|Cytoxan|50 mg/kg/dose will be given IV on day -5,-4, -3, -2 over 1 hour. The total dose to be given over 4 days is 200 mg/kg.
16218823|NCT01247688|Drug|Fludarabine|40mg/m2/day will be given IV over 1 hour on day -4, -3, -2
16218824|NCT01247688|Radiation|Total Body Irradiation (TBI)|1.75Gy/fraction will be given on day -9, -8, -7, -6
16218825|NCT01247688|Procedure|Cord Blood Stem Cell Infusion|The cord blood stem cells will be infused on day 0
16218826|NCT01247675|Drug|ACP-001 (TransCon hGH)|s.c., weekly injection
16218827|NCT01247675|Drug|ACP-001 (TransCon hGH)|s.c., weekly injection
16218828|NCT01247675|Drug|ACP-001 (TransCon hGH)|s.c., weekly injection
16218829|NCT01247675|Drug|Omnitrope|s.c., daily injection
16218830|NCT01247649|Device|Physical Logic Continuous Glucose Monitoring System|Patients will be monitored to assess continuous blood glucose levels using the study device (Physical Logic) and reference methods, during 2-3 clinic visits, lasting 6-8 hours each
16218831|NCT01247636|Other|Balance- training and home-exercise|Balance-training admitted at the geriatric hospital Home-exercise or advice to be generally active
16218832|NCT01247636|Other|Balance-training and home-exercise|The aim of the intervention was to enhance health-related quality of life, self-efficacy and physical function through education and exercise. The education program consisted of information given both oral and in writing regarding the benefits of physical activity. The aim was to increase the participants knowledge about the benefits of physical activity and to stimulate them to integrate physical activity into their immediate environment during daily routines. They were given an exercise-log and were advised to write down all their daily activities and exercise. The exercise program were conducted 2 times per week for 45 min per session. The content of these sessions were balance training with main focus on balance-exercises considered essential for daily living.
16218833|NCT01247623|Biological|GV1001|
16218834|NCT01247584|Genetic|DNA analysis|
16218835|NCT01247584|Genetic|mutation analysis|
16218836|NCT01247584|Genetic|polymerase chain reaction|
16218837|NCT01247584|Other|laboratory biomarker analysis|
16218838|NCT01247571|Drug|Pazopanib Hydrochloride|Given PO
16218839|NCT01247558|Other|Metanx® (a medical food)|Patient cohort compliant on Metanx® BID therapy for >120 days
16218840|NCT01247558|Other|Not treated with Metanx®|Non-treated comparative cohort
16218841|NCT01247545|Procedure|Remote ischaemic preconditioning|Blood pressure cuff placed on upper arm and inflated to 200mmHg for 5 minutes then deflated for 5 minutes - this cycle is repeated a total of 4 times.
16218842|NCT01247545|Procedure|Control|Control treatment (sham RIC) will consist of four 5-minute simulated inflations of a blood pressure cuff placed on the upper arm. The inflations will be separated by 5-minute periods when the blood pressure cuff will be deflated.
16218843|NCT01247532|Behavioral|Mindfulness-Based Stress Reduction - Cancer-Related Fatigue|7 week 2 hour class
16218844|NCT01247519|Other|Post-hospitalization care|Post-hospitalization care included telephone call contact for caring after discharge, for opening for question, and for health education.
16218982|NCT01246310|Dietary Supplement|Placebo|
16218845|NCT01247493|Drug|induction chemotherapy (fludarabine, cytarabine, idarubicin)|fludarabine, cytarabine, idarubicin
16218846|NCT01247467|Other|Breast Tumor Blocks|
16218847|NCT01247454|Behavioral|academic detailing|EHR message that encourages providers to consider ASA therapy for patients at high-risk for developing cardiovascular disease is turned off. Providers receive academic detailing.
16218848|NCT01247454|Behavioral|Electronic Health Record (EHR) prompt|EHR message that encourages providers to consider ASA therapy for patients at high-risk for developing cardiovascular disease is replaced with a message asking providers to consider terminating aspirin in patients who do not have appropriate cardiovascular disease.
16218849|NCT01247454|Behavioral|EHR prompt and patient prompt|EHR message that encourages providers to consider ASA therapy for patients at high-risk for developing cardiovascular disease is replaced with a message asking providers to consider terminating aspirin in patients who do not have appropriate cardiovascular disease. And a brief information sheet is distributed to patients prior to their visit asking them to discuss ASA therapy for primary prevention with their provider.
16218850|NCT01247441|Other|Clinical data|
16218851|NCT01247428|Device|MiStent SES|The MiStent SES is a device/drug combination comprised of two components; a stent and a drug product (sirolimus within an absorbable polymer coating).
16218852|NCT01247402|Device|drug eluting balloon angioplasty|3 microgram Paclitaxel/mm2 on balloon, 60s application
16218853|NCT01247402|Device|standard balloon angioplasty|standard balloon angioplasty
16218854|NCT01247389|Procedure|laparoscopic colectomy|Laparoscopic segmental colectomy with planned abdominal extraction site
16218855|NCT01247376|Device|Cooling and compression|Cooling and compression of the knee postoperatively with an Aircast device.
16218856|NCT01247363|Drug|LY2608204|Administered orally.
16218857|NCT01247350|Drug|LY3009104|Administered orally
16218858|NCT01247350|Drug|Placebo|Administered orally
16218859|NCT01247337|Drug|Oxaliplatin, capecitabine, gemcitabine, cetuximab|Intrahepatic oxaliplatin
16218860|NCT01247337|Drug|Oxaliplatin, capecitabine, gemcitabine cetuximab|Oxaliplatin given intravenous
16218861|NCT01247324|Drug|Interferon beta-1a|
16218862|NCT01247324|Drug|Ocrelizumab-matching placebo|
16218863|NCT01247324|Drug|Ocrelizumab|
16218864|NCT01247324|Drug|Interferon beta-1a-matching placebo|
16218865|NCT01247311|Dietary Supplement|Dietary supplement|Placebo given orally 3xweek for six months
16218866|NCT01247311|Dietary Supplement|Vitamin D|5000 IU vitamin D given orally 3xweek for six months
16218867|NCT01247311|Dietary Supplement|Vitamin D|0.5ug 1,25 vitamin D given orally 3xweek for six months
16218868|NCT01247298|Combination Product|Stereotactic Body Radiation Therapy (SBRT)|This investigational study will evaluate the combination of TACE along with high dose SBRT. TACE has been used extensively in the palliative treatment of hepatocellular carcinoma (HCC). It will be performed by the Interventional Radiologist prior to radiation therapy.
16218869|NCT01247285|Drug|Fluoxetine Hydrochloride|90 mg Capsules
16218870|NCT01247285|Drug|PROZAC WEEKLY®|90 mg Capsules
16218871|NCT01247272|Drug|Fluoxetine Hydrochloride|90 mg Capsules
16218872|NCT01247272|Drug|PROZAC WEEKLY®|90 mg Capsules
16218873|NCT01247259|Drug|Pangramin®|During a 4-week increasing-dose phase, the patients increased the daily dose from 1 to 5 drops of 1.6 STU/mL solution from day 1 to 10, 1 to 5 drops of 8 STU/mL solution from day 11 to 15, 1 to 5 drops of 40 STU/mL solution from day 16 to 20, 1 to 5 drops of 200 STU/mL solution from day 21 to 25, and 1 to 5 drops of 1000 STU/mL solution from day 26 to 30. After reaching the maintenance dose, 5 drops of 1000 STU/mL solution, the patients took the allergen three times per week during the maintenance phase.
16218874|NCT01247246|Drug|SCV-07|clinical trial material; (placebo or SCV 07) at doses of 0 (placebo), 0.1, 0.3, and 1.0 mg/kg will be administered sc
16218875|NCT01247246|Drug|Placebo|Placebo
16218876|NCT01247233|Radiation|Whole Breast Irradiation + Boost or Hypofractionated irradiation|Whole Breast Irradiation 50 Gy + Boost 16 Gy or Whole breast, either 40 Gy in 15 fractions in 3 weeks or 42.5 Gy in 16 fractions in 3 weeks
16218877|NCT01247233|Radiation|Accelerated partial breast irradiation|Tumor bed 40 Gy in 10 fractions, 2 fractions of 4 Gy per day in 5 to 7 days.
16218878|NCT01247220|Drug|Ranibizumab|Intravitreal Ranibizumab 0.5 mg
16218879|NCT01247220|Procedure|Peripheral Laser|Angiography-directed peripheral laser
16218880|NCT01247207|Drug|Ataluren|Ataluren will be administered as per the dose and schedule specified in the arm.
16218881|NCT01247194|Drug|PPI-461|capsule, oral, once daily for 3 days
16218882|NCT01247194|Drug|Placebo|capsules, oral, once daily for 3 days
16218883|NCT01247181|Other|Mobile phone text message|Weekly message with motivational content
16218884|NCT01247181|Other|Usual care|Usual care provided at clinic
16218885|NCT01247168|Drug|AZD2461|oral capsules, continuous dosing and intermittent dosing
16218886|NCT01247129|Procedure|Delay procedure of SIEA flap.|Ligating the deep inferior epigastric artery ipsilaterally to the planned raising of the SIEA flap 2 weeks prior to the reconstructive procedure.
16218887|NCT01247103|Drug|AZD4316|Single oral doses of AZD4316 suspension in the fasted state. In one group in Part A, subjects will receive a second dose of AZD4316 in the fed state (within 30 min after receiving a high fat breakfast)
16218888|NCT01247103|Drug|AZD4316|Multiple oral doses of AZD4316 suspension. It's planned that doses will be administered in the fasted state, however, if in Part A it's shown that food increases absorption of AZD4316, then doses will be administered after a meal.
16218889|NCT01247103|Other|Placebo|Placebo to match AZD4316
16218890|NCT01247090|Drug|Vasopressin - Very Low Dose|Intradialytic vasopressin (AVP) infusion. The dose is calculated based upon the individual's weight in kilograms. A kilogram is equal to 2.2 pounds. For example, a person who weighs 70 kg (or 154 pounds) would receive a dose equal to 0.15 mU * 70 kg, or 10.5 mU of AVP per minute by infusion at their thrice-weekly dialysis treatments.
16218891|NCT01247090|Drug|Vasopressin - Low Dose|Intradialytic vasopressin (AVP) infusion. The dose is calculated based upon the individual's weight in kilograms. A kilogram is equal to 2.2 pounds. For example, a person who weighs 70 kg (or 154 pounds) would receive a dose equal to 0.30 mU * 70 kg, or 21 mU of AVP per minute by infusion at their thrice-weekly dialysis treatments.
16220504|NCT01234558|Drug|GLYX-13|single IV dose
16218892|NCT01247090|Drug|Placebo Comparator|Participants in Group 3 will receive an equal volume of normal saline (placebo) infusion during their standard thrice-weekly dialysis treatments.
16218893|NCT01247077|Other|selenium|200 ug selenium once daily
16218894|NCT01247077|Other|placebo|
16218895|NCT01247064|Drug|Nebulized 3% saline|4 mL of nebulized 3% saline once
16218896|NCT01247064|Drug|Nebulized 0.9% Normal Saline|4 mL of 0.9% nebulized normal saline once
16218897|NCT01247051|Procedure|Precoating|preoperative filling of heart lung machine with patients blood
16218898|NCT01247051|Procedure|Standard priming|preoperative filling of heart lung machine with colloids
16218899|NCT01247038|Device|Metal on ceramic articulation|Metal on ceramic articulation against metal-on-metal articulation using the same Recap Acetabular cup
16218900|NCT01247038|Device|Metal-on-Metal|Metal on Metal articulation
16218901|NCT01247025|Other|No intervention|This study will not contain a specific intervention
16218902|NCT01247012|Dietary Supplement|Omegaven|Omegaven 1g/kg/day until infant receiving full enteral feeds
16218903|NCT01247012|Dietary Supplement|Lipid minimization|"1g/kg/day daily until infant receiving full enteral feeds
~IF conjugated bili rises above 100, crossover to Omegaven (1gram/kg/day)"
16218904|NCT01246999|Biological|Live attenuated Influenza vaccine|0.2 mL dose delivered through nasal spray, 0.1 ml in each nostril, 2 doses separated by 28 days
16218905|NCT01246999|Biological|Trivalent Influenza Vaccine|.25 mL given intramuscularly to children 24 to 36 months of age, 2 doses given 28 days apart, .5 mL given intramuscularly to children 37 months to 9 years of age, 2 doses given 28 day s apart.
16218906|NCT01246999|Biological|TIV followed by LAIV|TIV .25 mL given intramuscularly to children 24 to 36 months of age or .5 mL given intramuscularly to children 37 months to 9 years of age, followed by FluMist 0.2 mL delivered by nasal spray (.1 mL in each nostril)28 days later
16218907|NCT01246999|Biological|LAIV followed by TIV|LAIV .2 mL given through nasal spray (.1 mL in each nostril) Followed by TIV .25 mL given intramuscularly to children 24 to 25 months of age or .5 mL given intramuscularly to children 36 months to 9 years of age 28 days later
16218908|NCT01246986|Drug|LY2157299|Administered orally
16218909|NCT01246986|Drug|Sorafenib|Administered orally
16218910|NCT01246986|Drug|Ramucirumab|Administered IV
16218911|NCT01246973|Drug|Curcumin|4 Curcumin C3 Complex 500mg capsules (2.0 g) taken orally 3 times/day throughout course of radiation treatments plus one week
16218912|NCT01246973|Drug|Placebo|4 placebo capsules taken orally 3 times/day throughout course of radiation treatments plus one week
16218913|NCT01246960|Biological|Ramucirumab|Administered intravenously
16218914|NCT01246960|Drug|Placebo|Administered intravenously
16218915|NCT01246960|Drug|Oxaliplatin|Administered intravenously
16218916|NCT01246960|Drug|Leucovorin|Administered intravenously
16218917|NCT01246960|Drug|5-Fluorouracil|Administered intravenously
16218918|NCT01246947|Procedure|Tricuspid valve repair|Randomized to receive Tricuspid valve repair using a rigid 3-dimensional annuloplasty ring using standard techniques, during Mitral surgery.
16218919|NCT01246947|Other|Mitral surgery alone|Randomized to Mitral surgery alone
16218920|NCT01246934|Other|ASR METHOD|
16218921|NCT01246921|Drug|Fluticasone proprionate 0.05% cream|Fluticasone proprionate 0.05% cream . In each patient a representative target lesion will be selected which will be assessed by digital analysis. Patients will apply Fluticasone proprionate 0.05% cream once daily during the first 3 months. I nthe following 9 months FP will be applied in a scheme of 3 days per week
16218922|NCT01246908|Drug|Placebo|Placebo administered twice per day for six weeks.
16218923|NCT01246908|Drug|CX157 (TriRima)|One tablet administered twice per day (total daily dose of 250 mg) for six weeks.
16218924|NCT01246895|Device|Microfracture with BST-CarGel|
16218925|NCT01246895|Device|Microfracture without BST-CarGel|
16218926|NCT01246882|Behavioral|Augmented activity feedback|Feedback about walking speed and amount of physical activity will be provided 3 times per week from data acquired from wireless sensors on each ankle.
16218927|NCT01246882|Behavioral|Speed-only feedback|Feedback about walking speed will be provided 3 times per week.
16218928|NCT01246830|Radiation|Panoramic radiograph, Cephalometric radiograph|2D images that are used for orthodontic treatment planning
16218929|NCT01246830|Radiation|Cone-beam computed tomography (CBCT)|CBCT data will be used in 3D cephalometric analysis softwares
16218930|NCT01246817|Drug|Temsirolimus|temsirolimus (standard schedule: 25 mg weekly, by 1-hour i.v. infusion)
16218931|NCT01246804|Drug|raltegravir single dose|single dose 400mg raltegravir
16218932|NCT01246804|Drug|ginkgo biloba multiple dose|15 days ginkgo biloba 120mg BID
16218933|NCT01246791|Drug|NPC-01|NPC-01, contains 1mg norethisterone and 0.02mg ethinyl estradiol will be administered orally under the fasting condition
16218936|NCT01246739|Procedure|Adrenalectomy|Adrenalectomy (open or laparoscopic)
16218937|NCT01246726|Procedure|CT SCAN|Prior to radiotherapy + after radiotherapy completion
16218938|NCT01246726|Procedure|MRI scan|Prior to radiotherapy + after completion of radiotherapy
16218939|NCT01246726|Procedure|3D Ultrasound scan|Prior to radiotherapy + after completion of radiotherapy
16218940|NCT01246713|Drug|Acetaminophen liquid formulation|Subjects in this arm will receive a 15mg/kg dose of a solid acetaminophen formulation.
16218941|NCT01246713|Drug|Acetaminophen solid formulation|Subjects in this arm will receive a 15mg/kg dose of a solid acetaminophen formulation.
16218942|NCT01246700|Other|Sensory Attention Focused Exercise (SAFEx)|"Consisted of 12 weeks for SAFEx intervention, 3 times a week for an hour each session. Participants complete dynamic balance activities and a variety of seated stretches and range of motion activities. Participants are cued to focus on sensation and proprioception of limbs.
~Group A received SAFEx for 12 weeks then received no treatment for 12 weeks."
16218983|NCT01246297|Other|Pulmonary Rehabilitation|Twice weekly exercise classes with an education component. For 8 weeks.
16220283|NCT01236313|Procedure|TEE report|Information will be collected during cardiac surgery.
16218943|NCT01246700|Other|Sensory Attention Focused Exercise (SAFEx)|"Consisted of 12 weeks for SAFEx intervention, 3 times a week for an hour each session. Participants complete dynamic balance activities and a variety of seated stretches and range of motion activities. Participants are cued to focus on sensation and proprioception of limbs.
~Group B received no treatment for 12 weeks, then received SAFEx for 12 weeks."
16218944|NCT01246687|Behavioral|e-Intervention|Dietary educational programme developed using Transtheoretical Model of Change and delivered via a website specific for Type 2 Diabetes patients.
16218945|NCT01246648|Procedure|Biopsy|dental extraction and gingival epithelial biopsy
16218946|NCT01246648|Procedure|biopsy|dental extraction and gingival epithelial biopsy
16218947|NCT01246648|Procedure|Biopsy|dental extraction and gingival epithelial biopsy
16218948|NCT01246635|Device|Trufit CB (Cartilage Bone) Implant|Implantation of 5,7, 9, or 11 mm Trufit CB Implants for small cartilage lesions. A maximum of two Trufit CB plugs may be implanted.
16218949|NCT01246635|Procedure|Microfracture if the knee|Creation of small holes through subchondral bone with the goal of stimulating cartilage growth
16218950|NCT01246622|Drug|cytarabine|Given IV
16218951|NCT01246622|Drug|lenalidomide|Given PO
16218952|NCT01246596|Procedure|dental root planing|The objective of root planing, otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or dental prophylaxis is to remove or eliminate the etiologic agents which cause inflammation: dental plaque, its products and calculus,[1] thus helping to establish a periodontium that is free of disease.[2]
16218953|NCT01246596|Procedure|dental root planing|The objective of root planing, otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or dental prophylaxis is to remove or eliminate the etiologic agents which cause inflammation: dental plaque, its products and calculus, thus helping to establish a periodontium that is free of disease.
16218954|NCT01246596|Procedure|dental root planing|The objective of root planing, otherwise known as conventional periodontal therapy, non-surgical periodontal therapy, or dental prophylaxis is to remove or eliminate the etiologic agents which cause inflammation: dental plaque, its products and calculus, thus helping to establish a periodontium that is free of disease.
16218955|NCT01246583|Drug|CP-690,550 Ointment 1|2% CP-690,550 Ointment 1 twice daily for 4 weeks
16218956|NCT01246583|Drug|Vehicle 1|Vehicle 1 twice daily for 4 weeks
16218957|NCT01246583|Drug|CP-690,550 Ointment 2|2% CP-690,550 Ointment 2 twice daily for 4 weeks
16218958|NCT01246583|Drug|Vehicle 2|Vehicle 2 twice daily for 4 weeks
16218959|NCT01246570|Behavioral|Exercise training|The patients will meet for organized exercise training once monthly and also exercise testing every third month.
16218960|NCT01246570|Other|Control|The patients will receive the usual care provided by the hospitals and the community health services
16218961|NCT01246557|Drug|Lenalidomide|"Lenalidomide - Revlimid®: an analogue of thalidomide, is an immunomodulator agent with anti-angiogenic properties. The chemical name is 3-(4 ́-aminoisoindoline-1 ́ona)-1- piperidine-2,6-dione.
~REVLIMID® (lenalidomide) is available in capsules of 5 mg, 10 mg and 15 mg p.o.. Each capsule contains lenalidomide as active ingredient and the following non active ingredients: anhydrous lactose, microcrystalline cellulose, sodium croscarmellose and magnesium stearate."
16218962|NCT01246557|Drug|Dexamethasone|Dexamethasone will be administered as 20 mg/day (on days 1 to 4) for oral administration.
16218963|NCT01246518|Drug|MOB015|Arm 1; MOB015 once a day for 3 months. Arm 2; MOB015 once a day for 9 months.
16218964|NCT01246505|Device|CTO Crossing and Percutaneous transluminal angioplasty|Crossing of the CTO with the BridgePoint Medical System and subsequent treatment of the CTO via PTA (specific devices to be used for PTA at investigators' discretion)
16218965|NCT01246492|Dietary Supplement|Artificial Sweeteners|A 400mL drink sweetened with 45g glucose and artificial sweetener will be consumed orally
16218966|NCT01246479|Procedure|Blood draw|blood draw at Month 12, Month 24 and Month 36.
16218967|NCT01246479|Biological|IC51 has given in the parent study IC51-322|No more vaccinations in IC51-324 since this a study for long-term follow-up on safety and immunogenicity after vaccinations in parent study IC51-322.
16218968|NCT01246466|Device|Hybrid: AtriCure Bipolar System & EP ablation procedure|AtriCure Bipolar System plus a catheter ablation
16218969|NCT01246453|Drug|Intrapleurally Alteplase vs Intrapleurally Urokinase|Alteplase 10 mg and urokinase 100000 intrapleurally administered, once daily for three days and if necessary 6 days
16218970|NCT01246440|Drug|Catumaxomab|Catumaxomab: 4 intraperitoneal infusions of catumaxomab over 11 days administered in a period of 3 hours through an intraperitoneal catheter with the following dosage: 1) 10 µg on Day 0. 2) 20 µg on Day 3. 3) 50 µg on Day 7. 4) 200 µg on Day 10.
16218971|NCT01246427|Drug|BRN01|2 tablets every morning and every evening during 8 to 10 weeks. Each patient will receive 1 set of 5 treatment boxes (60 tablets/box).
16218972|NCT01246427|Drug|Placebo|2 tablets every morning and every evening during 8 to 10 weeks. Each patient will receive 1 set of 5 treatment boxes (60 tablets/box).
16218973|NCT01246401|Drug|Extended-Release Naltrexone|Extended-Release Naltrexone (Vivitrol), once a month by IM injection, for a total of 6 months. Dosage is 380mg
16218974|NCT01246375|Device|Dual energy X-ray absorptiometry|Device which measures bone density
16218975|NCT01246362|Drug|Control|Given placebo
16218976|NCT01246362|Drug|Etoricoxib|Given etoricoxib 120mg 24 hours preoperatively and 120mg 2 hours preoperatively
16218977|NCT01246349|Behavioral|Motivational Interviewing (Treatment Group)|Motivational interviewing (MI) can be defined as a client-centered, directive method of therapy for enhancing intrinsic motivation to change by exploring and resolving ambivalence (Miller and Rollnick, 2002). MI manifests through specific strategies, such as reflective listening, summarization, shared decision making, and agenda setting.
16218978|NCT01246349|Behavioral|Social Skills Training (Control Group)|Within the social skills training framework, advice is given to clients and sessions are focused on assigning goals for clients to work towards without specific regard for their readiness to change. The intervention is aimed at finding appropriate ways to navigate typical social situations (e.g., how to negotiate with parents).
16218979|NCT01246336|Other|collection of exhaled breath|no intervention
16218980|NCT01246323|Procedure|Spinal anesthesia with Fentanyl+ Morphine|Fentanyl 15 microgram Morphine 0.1-0.5 mg
16218981|NCT01246310|Dietary Supplement|Inositol|
16218984|NCT01246297|Other|Usual post operative care|Usual post operative care for post lung lobectomy patients for 8 weeks post discharge.
16218985|NCT01246284|Drug|Triamcinolone acetonide|Injections will be given within a 3 cm2 area of alopecia which will be divided into 4 quadrants. Three different concentrations of triamcinolone acetonide will be used: 2.5, 5, and 10 mg/ml. Each quadrant will receive injections with either triamcinolone acetonide 2.5 mg/ml, triamcinolone acetonide 5 mg/ml, triamcinolone acetonide 10 mg/ml, or normal saline as a control. Injection of 0.1 ml will be given intradermally using a 30 gauge half inch long needle attached to a 3 ml syringe. Each quadrant will receive approximately 7 injections per treatment session so the total dose of triamcinolone acetonide will be around 13 mg. Injections will be given vertically, with the beveled side of the needle directed to the opposite side and 2 mm away from the margin of the adjacent quadrant to avoid a diffusion effect. The treatment will be repeated every 4 to 6 weeks for a total of 6 treatment sessions.
16218986|NCT01246284|Other|Normal saline|
16218987|NCT01246258|Other|Vestibular evoked myogenic potentials (VEMPs)|Standard test of balance function
16218988|NCT01246258|Other|Utricular centrifugation test|Standard test of balance function
16218989|NCT01246232|Drug|Amisulpride|Clozapine augmentation with another second-generation antipsychotic, amisulpride (400mg amisulpride for the first 4 weeks, then the option of titrating up to 800mg amisulpride for the remaining 8 weeks).
16218990|NCT01246232|Drug|placebo|Clozapine augmentation with 1 capsule placebo for the first 4 weeks, then the option of titrating up to 2 capsules placebo for the remaining 8 weeks).
16218991|NCT01246219|Drug|GH treatment (Genotropin)|4 years treatment with GH
16218992|NCT01246219|Drug|1 year treatment with placebo followed by optional 3 years of GH treatment|1 year treatment with placebo followed by optional 3 years of GH treatment
16218993|NCT01246206|Drug|Tacrolimus and Thymoglobulin|"Intravenous Tacrolimus 0.03 mg/kg/d, beginning day -3, where day 0 is the day of stem cell infusion or transplant. Intravenous tacrolimus will be discontinued once the participant starts eating, and the drug will then be given orally at a dose of approximately 4 times the intravenous dose. Tacrolimus will be discontinued starting 100 days after transplant unless signs of acute and chronic GVHD develop or if severe toxicity occurs. Thymoglobulin will be given 0.5 mg/kg day-3, Thymoglobulin 1.5 mg/kg day -2, Thymoglobulin 2.5 mg/kg day -1. Thymoglobulin will be given intravenously over 6 hours."
16218994|NCT01246193|Drug|CKD-828(FDC)|Drug: Telmisartan 80mg + S-Amlodipine 2.5mg(FDC) Tablet, Oral, Once Daily
16218995|NCT01246193|Drug|Combination Therapy|"Drug: Telmisatan 80mg Tablet, Oral, Once Daily
~Drug: S-Amlodipine 2.5mg Tablet, Oral, Once Daily"
16218996|NCT01246180|Drug|Diclofenac|diclofenac 5% vs placebo (topical application) cutaneous blood flow measurement using laser Doppler
16218997|NCT01246180|Drug|Amiloride|amiloride 1mM vs placebo (intradermal injection) cutaneous blood flow measurement using laser Doppler
16218998|NCT01246167|Device|Philos|"Conservative treatment versus Philos locking plate in 2 part fracture group.
~Conservative treatment versus Philos locking plating versus Epoca prosthesis in MFF group."
16218999|NCT01246167|Device|Epoca|Conservative treatment versus Philos locking plate versus Epoca fracture prosthesis in MFF group
16219000|NCT01246167|Other|Control group|Conservative control group
16219001|NCT01246154|Other|EXERCISE TRAINING|EXERCISE TRAINING
16219002|NCT01246102|Drug|AT13387|Treatment will be administered as a 1-hour IV infusion on 2 consecutive days of every week for 3 weeks, followed by a 1-week period without drug administration.
16219003|NCT01246089|Drug|ranibizumab injection|Ranibizumab intravitreal injection of 0,5 mg ( 0.05mL)
16219004|NCT01246076|Drug|Lenalidomide|
16219005|NCT01246063|Drug|carfilzomib|
16219006|NCT01246063|Drug|pegylated liposomal doxorubicin (PLD)|
16219007|NCT01246063|Drug|Dexamethasone|
16219008|NCT01246050|Other|HF training|These are CBOC Providers who received HF Training as the active intervention. HF training includes didactic lectures, case discussions and interactive symposia, course materials including teaching material, textbooks, copies of HF clinical guidelines and patient education material for distribution, participation in HF Clinics and Inpatient Heart Failure Rounds. Providers were given access to clinical pharmacist services Including medication and disease teaching, adjustment and uptitration. There was quarterly analysis of patient compliance including individualized confidential, non-punitive feedback to providers from a set of prespecified core HF performance measures.
16219009|NCT01246050|Other|No HF training|These are control providers drawn from the same CBOCs who have not received HF training, access to clinical pharmacist medication titration services or performance feedback
16219010|NCT01246037|Drug|Bisoprolol|In the first 4 months of study, the dose of the drug will be gradually increased; the titration scheme is based on the 'farmacotherapeutisch kompas' and monitored according to the ACC/AHA/ESC guidelines. Up titration will be performed under the responsibilities of an experienced heart failure cardiologist and pulmonologist.
16219011|NCT01246024|Device|ERG|scotopic and photopic ERG
16219012|NCT01246011|Drug|Argatroban and warfarin|Subjects with the presence of heparin PF4 antibodies without signs or symptoms of HIT post CABG will be randomized to receive argatroban and warfarin or no drug for one month.
16219013|NCT01245998|Drug|Dalteparin|dalteparin 5000 I.U./24 h s.c. for 6 weeks
16219014|NCT01245998|Drug|Dalteparin|dalteparin 15000 I.U./24 h s.c. for 6 weeks
16219015|NCT01245985|Radiation|carbon ion boost|patients receive induction chemotherapy with TPF for a maximum of 3 cycles followed by radioimmunotherapy with cetuximab as intensity-modulated radiotherapy (IMRT) plus carbon ion boost
16219016|NCT01245972|Procedure|PDL Treatment|Pulsed-dye laser (PDL) treatment at one of two settings.
16219017|NCT01245959|Drug|Docetaxel, cisplatin and fluorouracil|Patients receive docetaxel (60mg/m2 on day 1), cisplatin (60mg/m2 on day 1) and fluorouracil (600mg/m2 on Days 1 to 5) every three weeks for three cycles before the radiotherapy.
16219018|NCT01245959|Radiation|Concurrent chemoradiotherapy|Patients receive radical radiotherapy and cisplatin (100mg/m2) every three weeks for three cycles during radiotherapy.
16219019|NCT01245946|Procedure|Photodynamic therapy|Photodynamic therapy: 2 sessions separated by 2 weeks of TDF with topical ALA20% for 1.5 hrs, then irradiated with red light (Waldmann lamp) at a fluence of 37 J/cm2 for 7-9 minutes. From the sixth week will begin adapalene 0.1% gel until 12 weeks
16219097|NCT01245348|Genetic|SULT4A1-1 genetic test|SULT4A1-1 haplotype result (+/-)
16219020|NCT01245946|Drug|Conventional therapy|Conventional therapy: Topical adapalene gel 0.1% at night for 12 weeks plus doxycycline 100 mg / day for 6 weeks.
16219021|NCT01245920|Biological|DFDBA + Bio-Gide Membrane|For patients in the FDBA + membrane group, a layer 4 mm thick of cancellous allograft bone (Puros Cancellous, Zimmer Dental inc., Carlsbad, CA) will be placed over the buccal bone in the area of the implant. A resorbable collagen membrane (Bio-Gide, 13 x 25 mm, Osteohealth, Shirley, NY) will be trimmed to extend 5 mm beyond the implant borders and to cover the implant head. Following membrane placement over the bone graft, the gingival flaps will be closed and sutured with 4-0 Vicryl (Ethicon Inc., Sommerville, NJ) with passive tension flap closure.
16219022|NCT01245920|Other|Non-FDBA|Patients in the non-FDBA group will have gingival flaps closed with the same suturing technique.
16219023|NCT01245907|Behavioral|Applied relaxation|Applied relaxation given by Internet during 10 weeks as a number of text-documents, audio-files and e-mail mediated support from therapists
16219024|NCT01245894|Drug|Low-dose Rosuvastatin|Rosuvastatin 5mg/day for one year
16219025|NCT01245894|Drug|High-dose Rosuvastatin|Rosuvastatin 40mg/day for one year
16219026|NCT01245881|Device|Non-ablative fractional photothermolysis laser|"Wavelength: 1,550 nm;
~Energy: 15 mJ/MTZ;
~Total coverage: 20%;
~Total density: 1,048 MTZs/cm2;
~Density per pass: 131 MTZ/cm2;
~Number of passes: 8."
16219027|NCT01245881|Other|broad-spectrum sunblock (SPF 50+)|
16219028|NCT01245868|Drug|Lidocaine|
16219029|NCT01245868|Drug|bupivacaine|
16219030|NCT01245855|Drug|lipo-PGE1|those in the PGE1 group received additional 20 micrograms/day of lipo-PGE1 intravenously, starting at least 24 hours before PCI and continuing for 5 days
16219031|NCT01245842|Other|Hand exercise program|Hand exercise program three times/week for 12 weeks. In total four group sessions, otherwise home based. Weekly telephone calls from experienced physiotherapist/occupational therapist addressing adjustments of the exercise program and encouragement of program adherence.
16219032|NCT01245829|Other|Swabbing of observation chart|The observation charts to be studied will be stored on the DMH critical care unit and all existing non-laminated white charts removed for the duration of the study period. The observation charts will thereafter be used in the normal way as defined by nursing practice; blue charts from patient admission (irrespective of time) and white charts for each 24 hour period thereafter commencing at 8 am. On placement and after 24 hours of use, a standardised section of the patient observation area will be swabbed by the data collection researcher. The standardised area is defined as the section of the chart that is most comprehensively completed during the patient episode and is therefore most likely to become contaminated through contact. Use of white charts only is required in order to standardise the length of time each chart is in place between the two points of swabbing (white charts present at 8 am have been in use for exactly 24 hours).
16219033|NCT01245816|Drug|Eflornithine plus Sulindac|Eflornithine, 250 mg tablet, two tablets (500 mg) orally once a day; Sulindac, 150 mg tablet, one tablet orally once a day
16219034|NCT01245816|Drug|Eflornithine plus Placebo|Eflornithine, 250 mg tablet, two tablets (500 mg) orally once a day; Placebo, one tablet orally once a day
16219035|NCT01245816|Drug|Sulindac plus Placebo|Sulindac, 150 mg tablet, one tablet orally once a day; Placebo, two tablets orally once a day
16219036|NCT01245803|Drug|additional rosuvastatin loading|additional rosuvastatin (10mg p.o.)is given at 18 hours and 4-6 hours before PCI
16219037|NCT01245803|Drug|placebo control|sugar pill is given 18-24hr and 4-6hr before PCI as control
16219038|NCT01245790|Drug|fostamatinib|Oral tablets, single dose
16219039|NCT01245777|Drug|ferric carboxymaltose|20 women with Restless Legs Syndrome (RLS) and iron deficiency and/ or anaemia in the third trimester of pregnancy will receive intravenous Ferric carboxymaltose in one or two single doses.
16219040|NCT01245764|Biological|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (GARDASIL™)|
16219041|NCT01245764|Biological|Placebo|
16219042|NCT01245751|Biological|Zoster Vaccine, Live|Single approximately 0.65-mL subcutaneous injection of Zoster Vaccine, Live on Day 1 of the study
16219043|NCT01245725|Drug|Tirofiban (Aggrastat)|"Tirofiban (Aggrastat) will be dosed as a 25mcg/kg i.v. bolus followed by a 0.15mcg/kg/min i.v. infusion during a percutaneous coronary intervention plus two hours after the procedure.
~Patients will receive tirofiban (Aggrastat) on a background of oral anti-platelet agent(s) and either unfractionated heparin (50U/kg and repeat dosing guided per guidelines) or bivalirudin as per local practice and physician discretion."
16219044|NCT01245725|Drug|Placebo|"Placebo will be dosed as an i.v. bolus followed by an i.v. infusion during a percutaneous coronary intervention plus two hours after the procedure.
~Patients will receive placebo on a background of oral anti-platelet agent(s) and either unfractionated heparin (50U/kg and repeat dosing guided per guidelines) or bivalirudin as per local practice and physician discretion."
16219045|NCT01245712|Radiation|Accelerated Partial Breast Irradiation|Undergo APBI delivered with proton radiation
16219046|NCT01245712|Radiation|Proton Beam Radiation Therapy|Undergo APBI delivered with proton radiation
16219047|NCT01245712|Other|Quality-of-Life Assessment|Ancillary studies
16219048|NCT01245699|Behavioral|scenario-based training, real-time audiovisual CPR feedback, and post-event debriefing|scenario-based training for CPR, real-time audiovisual CPR feedback using R Series monitor-defibrillator during treatment, and post-event debriefing
16219049|NCT01245686|Behavioral|Lifestyle and medication intervention|The Heart to Health Intervention combines and enhances two previously tested interventions to reduce CVD risk (a counselor-based intervention to improve lifestyle and a web-based intervention to improve medication adherence). The new lifestyle and medication adherence intervention (delivered alternately in a one-on-one counseling or web-format) includes a decision aid on heart disease risk and risk-reducing options, general education on lifestyle and medication adherence, tips for overcoming barriers to CHD risk reduction, and goal setting and specification of first steps.
16219050|NCT01245673|Biological|Prevnar- Pneumococcal Conjugate Vaccine (PCV)|After study enrollment, patients will receive Prevnar- Pneumococcal Conjugate Vaccine (PCV). At Day #14, Day #42, and Day #90, Day #120 and Day #150, patients will receive a booster immunization with Prevnar- Pneumococcal Conjugate Vaccine (PCV).
16219051|NCT01245673|Other|Activated/costimulated autologous T-cell|For all patients, the cells will be expanded ex vivo for up to 12 days and then prepared for infusion ~day 2 post-transplant. The target number of costimulated T-cells for infusion will be ~ 5 x 10e10 T-cells total in 100-500 mL total volume.
16219052|NCT01245673|Drug|Revlamid® (Lenalidomide)|At about day 100 post-transplant, after completion of post-transplant immunological assessments and myeloma restaging studies, patients will be eligible to receive low-dose Revlamid® (Lenalidomide) 10 mg/day for maintenance therapy (10 mg/day) until progression of myeloma or development of intolerance.
16219053|NCT01245673|Biological|MAGE-A3/GM-GSF, Hiltonol® (Poly-ICLC)|After study enrollment, patients will receive both MAGE-A3/GM-CSF [+ coinjection of 2mg of Hiltonol®(Poly-ICLC)]. At Day #14, Day #42, Day #90, Day #120 and Day #150 patients will receive an additional immunization with MAGE-A3/GM-GSF, Hiltonol® (Poly-ICLC).
16219054|NCT01245660|Drug|LAPATINIB|Lapatinib, 1250 mg per day, per os, during 3 weeks +/- 5 days.
16219055|NCT01245647|Drug|Naltrexone, 50mg, once per day for 4 months|Naltrexone: Two thirds of the total study participants will receive the medication naltrexone. Each study participant will take a single pill once a day for 4 months.
16219056|NCT01245647|Other|Sugar pill, 50mg, once per day for 4 months|Placebo: One third of the participants will receive placebo pills that look the same as the active comparator but are really just inert pills. Each study participant will take a single pill once a day for 4 months.
16219057|NCT01245634|Drug|Placebo|iv infusion every 4 weeks, 32 weeks
16219058|NCT01245634|Drug|RO4905417|20 mg/kg iv infusion every 4 weeks, 32 weeks
16219059|NCT01245621|Behavioral|Later entry group|"Advanced Practice Palliative Care Nurse Interventionist instituting a phone-based: a) Charting Your Course (CYC)-Patient Curriculum (6-session manualized); b) Creativity Optimism Planning Expert Information (COPE) Caregiver Curriculum (3 session manualized) and c) ongoing contact as determined by the Palliative Care Team assessment/plan; and
~Comprehensive Palliative Care Team Assessment & Management Plan."
16219060|NCT01245621|Behavioral|Early palliative care intervention|"Advanced Practice Palliative Care Nurse Interventionist instituting a phone-based: a) Charting Your Course (CYC)-Patient Curriculum (6-session manualized); b) Creativity Optimism Planning Expert information(COPE) Caregiver Curriculum (3 session manualized) and c) ongoing contact as determined by the Palliative Care Team assessment/plan; and
~Comprehensive Palliative Care Team Assessment & Management Plan."
16219061|NCT01245608|Drug|Polypill|Polypill taken once daily for 5 years. Each pill contains acetylsalicylic acid 81 mg, atorvastatin 20 mg, hydrochlorothiazide 12.5 mg, valsartan 40 mg
16219062|NCT01245595|Drug|Aminophylline|5 mg/kg IV bolus then 1.8 mg/kg IV Q6 hours
16219063|NCT01245595|Drug|Placebo|Normal Saline
16219064|NCT01245582|Drug|oxaliplatin (SR96669)|"Pharmaceutical form:injection
~Route of administration: intravenous"
16219065|NCT01245582|Drug|capecitabine|"Pharmaceutical form:tablet
~Route of administration: oral"
16219066|NCT01245582|Drug|sorafenib|"Pharmaceutical form:tablet
~Route of administration: oral"
16219067|NCT01245569|Drug|Foster® 100/6 µg/unit dose|"Foster® (beclomethasone dipropionate 100 µg plus formoterol 6 µg/unit dose), 2 inhalations b.i.d. (daily dose of BDP extrafine 400 µg plus FF 24 µg)."
16219068|NCT01245569|Drug|Seretide Accuhaler® 500/50 µg/actuation|Seretide® Accuhaler® (fluticasone 500 μg plus salmeterol 50 μg/actuation), 1 inhalation b.i.d. (daily dose of fluticasone 1000 μg plus salmeterol 100 μg).
16219069|NCT01245556|Drug|BMS-908662|Capsules, Oral, escalating doses starting at 25 mg, Q 12 h daily, Continuously
16219070|NCT01245556|Drug|BMS-908662|Capsules, Oral, escalating doses starting at 25 mg Q 12 h daily for 3 weeks with 3 weeks interval for 4 cycles, then Q12 h daily for 3 weeks every 12 weeks, Continuously
16219071|NCT01245556|Drug|Ipilimumab|Vial, IV, escalating doses starting at 3 mg/kg, Once every 3 weeks for 6 weeks, then once every 12 weeks, Continuously
16219072|NCT01245556|Drug|Ipilimumab|Vial, IV, escalating doses starting at 3 mg/kg, Once every 6 weeks for 4 cycles, then once every 12 weeks, Continuously
16219073|NCT01245543|Drug|AC480IV|AC480IV will be administered as an infusion using a dose escalation design.
16219074|NCT01245543|Drug|Docetaxel|Docetaxel will be administered intravenously, initially as monotherapy and subsequently in combination with docetaxel immediately following AC480IV administration.
16219075|NCT01245530|Drug|Aricept|Aricept Comparator Intervention: Drug: Aricept 5~10 mg orally every day for 24weeks
16219076|NCT01245530|Drug|INM-176|INM-176: Experimental Intervention: Drug:INM-176 600~1200 mg orally every day for 24weeks
16219077|NCT01245517|Other|Education|Dietary Phosphorus Education Program
16219078|NCT01245504|Other|Assessed for socket fit|Subjects are clinically assessed during standing to see how well computer manufactured sockets fit
16219079|NCT01245491|Other|Vibration|Whole-body vibration, 17 Hz, 1.1ms-2
16219080|NCT01245465|Other|Profermin|Medical Food (food for special medical purposes)
16219081|NCT01245452|Drug|Tocilizumab|Tocilizumab (8 mg/kg monthly from week 0 to 20)
16219082|NCT01245452|Drug|Methotrexate|MTX at a dose ranging from 10 mg/week at baseline to 20 mg/week at week 8
16219083|NCT01245439|Drug|tocilizumab [RoActemra/Actemra]|8 mg/kg intravenous infusion every 4 weeks for a total of 6 infusions
16219084|NCT01245426|Drug|GW870086 2mg|oral inhalation
16219085|NCT01245426|Drug|GW870086 4mg|oral inhalation
16219086|NCT01245426|Drug|GW870086 Placebo|oral inhalation
16219087|NCT01245426|Drug|GW870086 1mg|oral inhalation
16219088|NCT01245426|Drug|GW870086 3mg|oral inhalation
16219089|NCT01245413|Device|SenSura|Adhesive to stoma bag
16219090|NCT01245413|Device|Athena|Adhesive to stoma bag
16219091|NCT01245400|Device|Z-Lig|ACL replacement
16219092|NCT01245400|Device|allograft|ACL replacement
16219093|NCT01245387|Drug|Pegaptanib|Dosage recommendations for MACUGEN took place on the basis of the approved Summary of Product Characteristics (SmPC) and were adjusted solely according to medical practice. MACUGEN® is available as pre-filled syringe containing 0.3 mg MACUGEN® in 90 µL injection solution for intravitreal injection. Macugen injections were documented to reflect the routine clinical practice. Follow-up visits were only carried out and documented if they took place as part of the standard medical treatment for the respective case and were necessary for medical and/or therapeutic reasons.
16219094|NCT01245374|Device|Norditropin NordiFlex®|Daily administration by a subcutaneous injection (under the skin). Starting dose and frequency will be determined by the physician as part of normal clinical practice
16219095|NCT01245361|Drug|Infliximab|Infliximab 3 mg/kg wk 0,2,6
16219096|NCT01245361|Drug|sodium chloride|Group II : Placebo wk 0,2,6
16219098|NCT01245335|Device|BMAC injection|Injection of 40 ml of autologous bone marrow aspirate concentrate (BMAC injection) prepared with the SmartPReP2 BMAC System
16219099|NCT01245335|Device|Placebo injection|Injection of placebo into ischemic tissue of the lower extremity
16219100|NCT01245322|Drug|lactobacilli|women were given a seven days course of daily 2% vaginal clindamycin cream (Dalacin vaginal cream 2%, Pfizer Norway Ltd) together with oral clindamycin 300 mg BID for 7 days (Dalacin 300 mg, Pfizer Norway Ltd). Oral clindamycin treatment was also given to the patient's sexual partner.
16219101|NCT01245309|Procedure|scratching|endometrial scratching before COH in IVF
16219102|NCT01245309|Procedure|A PLACEBO PROCEDURE|A PLACEBO PROCEDURE
16219103|NCT01245296|Procedure|Timing of clamping the umbilical cord|The time passed after delivery until that the midwife stops circulation in the umbilical cord with a clamp.
16219104|NCT01245283|Other|normal activities and clinical care|Subjects will continue to participate in their normal activities and clinical care during the four month study. Telephone contact will be made weekly to encourage adherence to the knee management guidelines
16219105|NCT01245283|Other|Concentric Focused Resistance Exercise|Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
16219106|NCT01245283|Other|Eccentric Focused Resistance Exercise|Two resistance exercise sessions per week; 1 set of 10-12 repetitions of each exercise will be completed - leg press, leg curl, leg extension, chest press, seated row, overhead press, triceps dip, biceps curl, and calf press.
16219107|NCT01245270|Dietary Supplement|Bilberry capsule first, then control cap|"Male subjects aged >40 and <70 years, with type 2 diabetes controlling their diabetes by diet alone closely matched for adiposity as determined by waist circumference (n=8).
~Volunteers will be randomised double blinded into two groups (n=4 per group) and given a single capsule of either 0.47 grams of a bilberry extract (mirtoselect provided by Indena S.p.A (http://www.mirtoselect.info/) or a control capsule. Following a two week wash out period the volunteers will be asked to take a second single capsule of either of 0.47 grams of mirtoselect or a control capsule in a cross over study, the opposite of what they took the first time."
16219108|NCT01245270|Dietary Supplement|Control capsule first then bilberry cap|"Male subjects aged >40 and <70 years, with type 2 diabetes controlling their diabetes by diet alone closely matched for adiposity as determined by waist circumference (n=8).
~Volunteers will be randomised double blinded into two groups (n=4 per group) and given a single capsule of either 0.47 grams of a bilberry extract (mirtoselect provided by Indena S.p.A (http://www.mirtoselect.info/) or a control capsule. Following a two week wash out period the volunteers will be asked to take a second single capsule of either of 0.47 grams of mirtoselect or a control capsule in a cross over study, the opposite of what they took the first time."
16219109|NCT01245244|Drug|Morphine|Morphine oral mixture
16219110|NCT01245244|Other|orange juice|orange juice
16219111|NCT01245231|Genetic|protein expression analysis|
16219112|NCT01245231|Genetic|western blotting|
16219113|NCT01245231|Other|flow cytometry|
16219114|NCT01245231|Other|laboratory biomarker analysis|
16219115|NCT01245231|Other|medical chart review|
16219116|NCT01245205|Drug|Akt inhibitor MK2206|Given PO
16219117|NCT01245205|Drug|lapatinib ditosylate|Given PO
16219118|NCT01245205|Other|pharmacological study|Correlative studies
16219119|NCT01245205|Other|laboratory biomarker analysis|Correlative studies
16219120|NCT01245179|Drug|panobinostat|"Panobinostat oral capsules taken THRICE WEEKLY (Monday, Wednesday, and Friday) for 12 weeks, exploring the following dosing regimens:
~15 mg MWF 3 weeks on, 1 week off (if needed)
~15 mg MWF every week (starting dose)
~20 mg MWF 3 weeks on, 1 week off
~20 mg MWF every week"
16219121|NCT01245166|Drug|Acarbose|Acarbose 50 mg, per orem, thrice daily
16219122|NCT01245166|Drug|Metformin/Acarbose|Metformin HCl 500 mg plus Acarbose 50 mg Tablets, per orem, thrice daily
16219123|NCT01245153|Other|Rectal Balloon Training|Subjects in combined RBT and PFMT group are taught for foley catheter insertion technique. The catheter is inserted into the rectum until the lower end of the balloon is 1 cm inside from the anus. Then the balloon is blown with clean water starting at 10 cc. Then the volume is progress to 15 cc in 3rd week and 20 cc in 5th week
16219124|NCT01245153|Other|Pelvic floor muscle training (PFMT)|Standard pelvic floor muscle exercise (Pelvic floor muscle training;PFMT) is assigned for 6 weeks.
16219125|NCT01245140|Drug|alitretinoin|to receive verum (20 patients)
16219126|NCT01245140|Drug|Placebo|to receive placebo (10 patients)
16219127|NCT01245127|Drug|Ilaris|"Canakinumab 150 mg (or 2 mg/kg for patients weighing <40kg) every 8 weeks over a 6 months treatment period (i.e., weeks 0, 8, 16 and 24).
~At Day 7, patients who show an improvement, but not a clinical remission, will be given another 150 mg (or 2 mg/kg for patients weighing <40 kg) injection and continue at 300 mg (or 4 mg/kg for patients weighing <40 kg) every 8 weeks beginning at Week 8.
~Patients who show no improvement of symptoms and signs of Schnitzler's syndrome will not receive any additional canakinumab dose and will be offered corticosteroid therapy. These patients will return for a follow-up visit 2 weeks later (Day 21) for safety reasons and will be discontinued from the trial.
~If a patient flares twice during the study, physician may optionally change the dosing frequency to every 4 weeks."
16219128|NCT01245101|Drug|Raltegravir|Raltegravir 400 mg twice daily in addition to subject's antiretroviral therapy.
16219129|NCT01245101|Drug|Raltegravir|Raltegravir 400 mg twice daily in addition to subject's antiretroviral therapy.
16219130|NCT01245088|Drug|chondroitin sulfate|400 mg orally three times daily for 8 weeks
16219131|NCT01245075|Other|Deep brain stimulation|Deep brain stimulation on
16219132|NCT01245075|Other|Placebo|deep brain stimulation off
16219133|NCT01245062|Drug|GSK1120212|MEK inhibitor
16219134|NCT01245062|Drug|Chemotherapy|Investigator Choice of DTIC or paclitaxel
16219135|NCT01245049|Biological|Boostrix PolioTM|Single dose, intramuscular administration.
16219136|NCT01245049|Biological|RepevaxTM|Single dose, intramuscular administration.
16219137|NCT01245049|Biological|PriorixTM|Single dose, intramuscular or subcutaneous administration.
16219183|NCT01244711|Drug|quetiapine|Dosing will begin with Seroquel-XR 50 mg. at bedtime and will escalate weekly to Seroquel-XR 100mg., Seroquel-XR 200mg. and Seroquel-XR 300 mg depending on clinical response and side effects.
16219138|NCT01245036|Drug|Antituberculous therapy along with steroids|INH (300 mg/day) plus Rifampicin (450 mg/day if wt.<50 kg and 600 mg/day if wt. >50 kg) for six months Prednisolone 1 mg/kg/day for 6 weeks (maximum 80 mg) Prednisolone 0.75 mg/kg/day for 6 weeks (maximum 60 mg) Prednisolone 0.5 mg/kg/day for 3 months (maximum 40 mg) Prednisolone 0.25 mg/kg/day for 3 months (maximum 20 mg) Taper over the next three months Prednisolone 0.25 mg/kg EOD for 15 days Prednisolone 0.125 mg/kg EOD for 15 days Then taper by 5 mg every 15 days to complete one year
16219139|NCT01245023|Procedure|Laparoscopic adhesiolysis|Laparoscopic adhesiolysis and Sprayshield
16219140|NCT01245023|Procedure|Placebo-surgery|skin incisions without laparoscopy or related procedures
16219141|NCT01245010|Other|Water|Water and education will be provided
16219142|NCT01245010|Other|Education|Education
16219143|NCT01244997|Procedure|Dental Implant|This is designed to compare the response of the crestal bone after implants are placed whether delayed or immediately after tooth extraction in the maxilla.
16219144|NCT01244984|Drug|Fluticasone Furoate/GW642444 Inhalation Powder|Fluticasone Furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks
16219145|NCT01244984|Drug|Fluticasone Furoate Inhalation Powder|Fluticasone Furoate inhalation powder inhaled orally once daily for 52 weeks
16219146|NCT01244971|Drug|Acarbose|100mg, 3 times daily
16219147|NCT01244971|Behavioral|Exercise|Moderate combined exercise, 50 minutes 3 times per week
16219148|NCT01244971|Other|Exercise + Acarbose|See respective monotherapy description
16219149|NCT01244958|Biological|Rituximab|1000 mg Rituximab infusion
16219150|NCT01244958|Drug|Placebo|infusion of Sodium citrate, Polysorbate, Sodium chloride
16219151|NCT01244945|Dietary Supplement|L. reuteri DSM 17938|L. reuteri will be administered at 1x10^8 CFU dosage in form of tabs. In order to ensure colonization (run in), 4 tabs will be administered per os daily (4x10^8CFU/die) for 15 days. Then administration will continue with 2 tabs daily (2x10^8 CFU/die) for 90 days.
16219152|NCT01244945|Other|Placebo Group|Placebo tabs identical in form, taste and consistency to active tabs
16219153|NCT01244932|Drug|bupivacaine 0.5%|Patients will be given bupivacaine 0.5% in different doses (up-down study).
16219154|NCT01244906|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Patients will receive fludarabine, busulfan and cyclophosphamide as the conditioning regimen prior to an allo SCT. Patients will then receive 2 doses of cyclophosphamide post-transplant and utilize sirolimus and mycophenolate mofetil (in mismatched transplants) as GVHD prophylaxis.
16219155|NCT01244893|Device|Acuvue Advance Plus prePQ|silicone hydrogel contact lens manufactured prior to equipment process qualification activities.
16219156|NCT01244893|Device|Acuvue Advance Plus postPQ|silicone hydrogel contact lens manufactured after equipment process qualification activities.
16219157|NCT01244880|Other|Saline|Saline infusion for 56 minutes
16219158|NCT01244880|Drug|PF-02545920|PF-02545920 10 mg single dose
16219159|NCT01244880|Other|Ketamine|"Ketamine 0.23 mg/kg bolus over one min; and 0.58 mg/kg/hour maintenance for 56 minutes
~PF-02545920 10 mg tablet"
16219160|NCT01244880|Drug|PF-02545920|PF-02545920 10 mg tablet single dose
16219161|NCT01244880|Other|Saline|Saline infusion for 56 minutes
16219162|NCT01244880|Other|Placebo|Placebo tablet single dose
16219163|NCT01244880|Other|Ketamine|Ketamine 0.23 mg/kg bolus over one min; and 0.58 mg/kg/hour maintenance for 56 minutes
16219164|NCT01244880|Other|Placebo|Placebo tablet single dose
16219165|NCT01244867|Biological|20 micrograms dose H5 VLP|2 doses given 21 days apart of 20 micrograms of H5 VLP vaccine mixed with Alhydrogel
16219166|NCT01244867|Biological|30 micrograms dose H5 VLP|2 doses given 21 days apart of 30 micrograms of H5 VLP vaccine mixed with Alhydrogel
16219167|NCT01244867|Biological|45 micrograms dose H5 VLP|2 doses given 21 days apart of 45 micrograms of H5 VLP vaccine mixed with Alhydrogel
16219168|NCT01244867|Biological|45 micrograms non-adjuvanted H5 VLP|2 doses given 21 days apart of 45 micrograms of H5 VLP vaccine
16219169|NCT01244867|Biological|Placebo|2 doses given 21 days apart of the placebo
16219170|NCT01244854|Behavioral|Life Goals Collaborative Care|LGCC consists of 1) 10 sessions focused on CVD risk reduction through behavioral change within the context of patients' psychiatric symptoms; 2) participant goal setting in diet and exercise; 3) customized ongoing motivational interviewing (MI)-based patient contacts with a health specialist for 6 months, in addition to 4) strategies to increase provider access and support for behavioral change and medical management.
16219171|NCT01244841|Procedure|fast post MI care|All post MI investigations, treatment, start of medication, information are performed within 3 days after admittance.
16219172|NCT01244828|Drug|Asenapine|5 mg or 10 mg fast-dissolving sublingual tablets BID for up to 52 weeks
16219173|NCT01244815|Drug|asenapine|Asenapine tablets, administered sublingually twice daily at one of three dose levels (2.5 mg, 5.0 mg, or 10.0 mg)
16219174|NCT01244815|Drug|Placebo to match asenapine|Placebo tablets to match asenapine tablets, administered sublingually twice daily
16219175|NCT01244815|Drug|Rescue medication|For participants whose symptoms worsen or are not adequately controlled on assigned treatment, rescue medication may be administered during the trial in the following circumstances. For the control of agitation, anxiety, insomnia, restlessness, or akathisia and extrapyramidal symptoms (EPS) some benzodiazepines and EPS medications (i.e., anticholinergics) are allowed. Benadryl (diphenhydramine) and beta blockers are also permitted, provided that they are not taken within 8 hours of efficacy assessments.
16219176|NCT01244789|Drug|carboplatin and paclitaxel|6 courses of iv 3-weekly chemotherapy Carboplatin AUC5 Paclitaxel 175mg/m2
16219177|NCT01244789|Other|observation|active observation
16219178|NCT01244776|Device|acellular corneal matrix|Efficacy of acellular corneal matrix to restore stroma integrity and treat corneal ulcer after lamellar keratoplasty.
16219179|NCT01244763|Drug|FG-4592|Different dose levels and schedules
16219180|NCT01244750|Other|Non-Interventional|Non-Interventional
16219181|NCT01244737|Drug|[18F] FLT|[18F] FLT, intravenous, at a dose of 0.15 mCi/kg once before a PET scan
16219182|NCT01244724|Drug|Lexapro|Escitalopram will begin at 10mg. a day. Visits will occur biweekly for 12 weeks. Subjects with minimal or no response and minimal or no side effects after 4 weeks will have the dose increased to 20mg. a day. The maximum dose of escitalopram will not exceed the FDA-approved maximum dose of 20 mg per day.
16219184|NCT01244698|Drug|Cefadroxil discontinued early|All patients will receive 24 hours of IV Cefazolin (1g IV every 8 hr), as is universal practice for clean breast surgery. The interventional group will then discontinue antibiotics. Clindamycin IV 600mg every 6 hours for 24 hours will be used in penicillin allergic patients.
16219185|NCT01244698|Drug|Cefadroxil until drain removal|All patients will receive 24 hours of IV Cefazolin, as is universal practice for clean breast surgery. The control group will receive oral outpatient Cefadroxil (500mg 2 times a day) until the final drain is removed. This is the normal postoperative regimen. In case of significant penicillin allergy (defined as a history of urticaria or anaphylaxis associated with penicillin) patients will receive Clindamycin 600mg IV every 6 hours for 24 hours followed by clindamycin 300mg IV every 6 hours.
16219186|NCT01244685|Device|Deltex CardioQ Probe|Deltex CardioQ probe will be placed nasally in the operating room by the anesthesia team and fluid management will be administered via anesthesia protocol.
16219187|NCT01244672|Procedure|Ferguson|This is a modification of the Milligan-Morgan technique, whereby the incisions are totally or partially closed with absorbable running suture. A retractor is used to expose the hemorrhoidal tissue, which is then removed surgically. The remaining tissue is either sutured or is sealed through the coagulation effects of a surgical device.
16219188|NCT01244672|Procedure|THD|Transanal hemorrhoidal dearterialization will be performed using an endoscopic ultrasonic probe. Approximately 7-8 hemorrhoidal arteries will be ligated at 1, 3, 5, 7, 9, 11 o'clock position as previously described in the literature. The ligation will be performed using a vicryl suture. The ultrasonic probe locates the arterial signal.
16219189|NCT01244659|Drug|Tacrolimus from EMS|Tacrolimus initial dose of 0.2 mg/kg/day Myfortic®: 720 to 1440 mg/day Steroids: methylprednisolone: first dose 500mg, 250 mg at first day and 125mg at second day, reducing to 30mg after third day post transplantation.
16219190|NCT01244659|Drug|Prograf|Prograf initial dose of 0.2 mg/kg/day Myfortic®: 720 to 1440 mg/day Steroids: methylprednisolone: first dose 500mg, 250 mg at first day and 125mg at second day, reducing to 30mg after third day post transplantation.
16219191|NCT01244633|Drug|Ecopipam|50 or 100 mg tablets given once per day for eight weeks
16219192|NCT01244620|Drug|sitaxentan|sitaxsentan 100 mg QD for 6 days
16219193|NCT01244620|Drug|tadalafil|tadalafil 40 mg QD for 6 days
16219194|NCT01244620|Drug|sitaxsentan|sitaxsentan 100 mg QD for 6 days
16219195|NCT01244620|Drug|tadalafil|tadalafil 40 mg QD for 6 days
16219196|NCT01244620|Drug|sitaxsentan|sitaxentan 100 mg QD for 6 days
16219197|NCT01244620|Drug|sildenafil|sildenafil 20 mg TID for 6 days
16219198|NCT01244607|Drug|Placebo|single i.v. administration
16219199|NCT01244607|Drug|NI-0801|single i.v. administration
16219200|NCT01244594|Other|Cycling with functional electrical stimulation|Subjects will cycle with functional electrical stimulation for one hour, 3 times per week at Magee Rehab's outpatient center. Subjects will cycle for a total of 26 weeks (6 months).
16219201|NCT01244581|Drug|Amoxicillin-clavulanate|Amoxicillin-clavulanate 40 mg/kg/day in two daily doses for 7 days
16219202|NCT01244581|Drug|Placebo|Placebo mixture in two daily doses for 7 days
16219203|NCT01244568|Behavioral|Prostate cancer treatment DESI|DESI is a 50 minute program on treatment choices for prostate cancer that will be given out to the experimental group. The program explains several treatment options including surgery (radical prostatectomy), radiation therapy (external beam and/or brachytherapy), hormone therapy, and active surveillance and watchful waiting. The program's intended audience is men with early state prostate cancer who are trying to make a treatment decision.
16219204|NCT01244555|Other|ultrasound|Twice weekly ultrasound sessions for 6 weeks
16219205|NCT01244555|Other|massage|Twice weekly massage sessions for 6 weeks
16219206|NCT01244542|Other|unpleasant stimuli|
16219207|NCT01244529|Device|galy A Plus|galyfilcon A Plus, BC: 8.3 or 8.7
16219208|NCT01244529|Device|seno A|senofilcon A, BC:8.4 or 8.8
16219209|NCT01244529|Device|galy A|galyfilcon A , BC: 8.3 or 8.7
16219210|NCT01244516|Device|galyfilcon A, BC 8.30|galyfilcon A, BC 8.30 soft contact lens
16219211|NCT01244516|Device|lotrafilcon B, BC 8.60|lotrafilcon B, BC 8.60 soft contact lens
16219212|NCT01244516|Device|comfilcon A, BC 8.60|comfilcon A, BC 8.60 soft contact lens
16219213|NCT01244503|Drug|Sodium Octanoate Breath Test|100 mg of 13-C labeled sodium octanoate (Octanoate for short) is to be dissolved in 1 cup of tap water and administered to subject after baseline breath collection is completed.
16219214|NCT01244490|Drug|Extended-release Guanfacine Hydrochloride|Tablet, once daily, optimised dose (1mg to 7mg based on age and weight), 6-week maintenance duration on optimised dose.
16219215|NCT01244490|Drug|Atomoxetine Hydrochloride|Capsule, once daily, optimised dose (10mg to 100mg based on weight), 8-9-weeks maintenance duration on optimised dose
16219216|NCT01244490|Drug|Placebo Comparator|Placebo
16219217|NCT01244477|Behavioral|Group CPT-C|Participants will be randomly assigned to participate in CPT-C or a 12 week waitlist control group. Waitlist control subjects will participate in CPT-C after the 12 weeks.
16219218|NCT01244464|Biological|IMOVAX Polio™-Inactivated types 1, 2, and 3 poliovirus D vaccine|0.5 mL, at 2, 3, and 4 months; Intramuscular
16219219|NCT01244451|Drug|Ofatumumab|Ofatumumab will be administered at the dose of 300 mg IV D1 and 1000 mg IV D8 1st course; 1000 mg IV D1, 2nd -6th courses.
16219220|NCT01244451|Drug|Bendamustine|Bendamustine will be infused at the doses of 70 mg/m2 IV on days D1 and D2 of each course.
16219221|NCT01244438|Drug|FP-1039|FP-1039 will be administered at a dose up to 16 mg/kg intravenously over 30 minutes once a week.
16219222|NCT01244425|Drug|Fibrin Sealant (FS) VH S/D 500 s-apr|Dosage form: spray application; dosage frequency: single application
16219223|NCT01244425|Other|Manual compression|Dosage form: surgical gauze swab; dosage frequency: single application
16219224|NCT01244399|Dietary Supplement|Inositol|
16219225|NCT01244360|Dietary Supplement|resveratrol|Subject will take resveratrol supplement for 4 weeks, with optional additional 4 week treatment period.
16219226|NCT01244360|Other|Placebo Comparator: Sugar Pill|Subject will take placebo for daily for 4 weeks, with optional additional 4 week treatment period.
16219227|NCT01244347|Drug|folic acid|
16219228|NCT01244347|Drug|folic acid|
16219273|NCT01244009|Drug|MK-4827|MK-4827 will be administered daily as an oral formulation in continuous 21-day cycles.
16219229|NCT01244334|Drug|Difluprednate ophthalmic emulsion 0.05%|Difluprednate ophthalmic emulsion 0.05%: 29 days total, total of 7 drops prior to surgery, and 3 more following surgery while at the surgery center, then Q2H on day of surgery, then QID for 1 week, then BID for 1 week, then stop.
16219230|NCT01244334|Drug|Prednisolone acetate 1%|Prednisolone acetate 1% : 29 days total, total of 7 drops prior to surgery, and 3 more following surgery while at the surgery center, then Q2H on day of surgery, then QID for 1 week, then BID for 1 week, then stop.
16219231|NCT01244295|Behavioral|Complicated Grief Treatment|Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided weekly.
16219232|NCT01244295|Behavioral|Interpersonal Therapy|Standard form of interpersonal psychotherapy delivered for 16 sessions weekly.
16219233|NCT01244282|Procedure|fMRI with sensory stimulation|BOLD fMRI study with sensory stimulation followed by fMRI in the presence of increasing concentrations of ferumoxytol (Feraheme™)
16219234|NCT01244269|Drug|Methylphenidate|Methylphenidate 10mg tablets will be overencapsulated in gelatin capsules for blinding. Subjects will take 1 capsule three times daily for a total of 7 doses.
16219235|NCT01244269|Drug|Methylphenidate|Methylphenidate 20mg three times daily for a total of 7 doses.
16219236|NCT01244269|Drug|Placebo 10|Blind gelatin capsule three times daily for a total of 7 doses.
16219237|NCT01244269|Drug|Placebo 20|Blind gelatin capsule three times daily for a total of 7 doses
16219238|NCT01244256|Drug|Clotrimazole + Gentamicin + Beclomethasone|Treatment with Clotrimazole + Gentamicin + Beclomethasone
16219239|NCT01244256|Drug|Clotrimazole + Gentamicin|Treatment with Clotrimazole + Gentamicin
16219240|NCT01244243|Device|Hand & Wrist Assisting Robotic Device|Treatment occurs in 2 hour sessions, 4 times a week over 3 weeks. In each treatment session, you will sit in a chair and have your weak hand attached to a mechanical device (the robot), which will help you open and close your hand. During the treatment, different types of objects (with varying shapes, sizes, and weight) will be placed into your hand. You will be given a variety of instructions related to the grasping, feeling, or identifying of the object in your hand. Sometimes these instructions will be given from the investigator and sometimes from the computer. You will often be asked to grasp, or release, each of these objects as best you can. You will also be asked to concentrate on the object in your hand. An example of what you may be asked to do is to name the object. During other times, you will play games, using the robot to control game parts on the computer screen. At other times, you will move your hand so that the robot can measure your hand function.
16219241|NCT01244230|Drug|fexofenadine/Allegra (M016455)|"Pharmaceutical form:dry syrup formulation to be suspended in water
~Route of administration: oral"
16219242|NCT01244217|Drug|fexofenadine/Allegra (M016455)|"Pharmaceutical form:dry syrup formulation to be suspended in water
~Route of administration: oral"
16219243|NCT01244204|Dietary Supplement|Vitamin D|Daily dose of 800IU of vitamin D
16219244|NCT01244204|Dietary Supplement|Placebo|Identically appearing capsules
16219245|NCT01244191|Drug|Tivantinib|Tivantinib 720 mg daily as 3 x 120 mg oral tablets given twice a day
16219246|NCT01244191|Drug|Placebo|Tivantinib Placebo tablets given twice a day
16219247|NCT01244191|Drug|Erlotinib|Erlotinib 150 mg oral tablets, given once a day
16219248|NCT01244178|Drug|Insulin|Intravenous Hyperinsulinemic therapy
16219249|NCT01244178|Drug|Insulin|Standard Intravenous Insulin Therapy
16219250|NCT01244165|Device|Cytrix|
16219251|NCT01244165|Other|Other treatments for pelvic organ prolapse|Treatments for pelvic organ prolapse using other products (standard of care for treatment of pelvic organ prolapse)
16219252|NCT01244152|Behavioral|Intensive diabetes self-management education|18 group classes led by a dietitian and peer supporters, and weekly telephone calls by peer supporters. Intervention focus was on diet and physical activity.
16219253|NCT01244152|Behavioral|Enhanced standard diabetes education|2 3-hour diabetes education classes taught by a health educator at a local clinic
16219254|NCT01244139|Drug|BIIB033|IV infusion of 0.3, 1, 3, 10, 30, 60 or 100 mg/kg
16219255|NCT01244139|Drug|Placebo|IV infusion dummy drug
16219256|NCT01244126|Drug|Intranasal fentanyl|2mcg/kg fentanyl IN
16219257|NCT01244126|Drug|morphine IM|0.1 mg/kg morphine IM for postop pain
16219258|NCT01244126|Drug|IV morphine|0.1 mg/kg morphine IV
16219259|NCT01244113|Drug|propofol|optimization of propofol dose from 1.5 mg/kg to 2.5 mg/kg using Dixon's up and down method during MRI scanning
16219260|NCT01244100|Drug|PL2200 fasted|Fasted state
16219261|NCT01244100|Drug|PL2200 fed|Fed state
16219262|NCT01244074|Behavioral|biofeedback training|
16219263|NCT01244061|Drug|Varenicline|Varenicline 1mg twice daily
16219264|NCT01244061|Drug|Placebo|Matched placebo twice daily
16219265|NCT01244048|Dietary Supplement|n3 long chain polyunsaturated fatty acids|Group 1 (placebo) Group 2 (0.8 g n3 LC-PUFA/d in 125 g yoghurt) Group 3 (3 g n3 LC-PUFA/d in 200 g yoghurt)
16219266|NCT01244035|Drug|Treatment A|MK-8266 1.3 mg orally twice daily (BID, 1 mg in the morning and 0.3 mg 8 hours later) plus placebo to match Treatment B on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266.
16219267|NCT01244035|Drug|Treatment B|MK-8266 0.1 mg orally administered every 2 hours as frequent divided dosing (FDD, total dose of 0.9 mg) plus placebo to match Treatment A on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266.
16219268|NCT01244035|Drug|Treatment C|Placebo to match MK-8266 Treatments A and B orally daily on Days 1 through 3. On Day 4, single dose of placebo to match MK-8266.
16219269|NCT01244035|Drug|Treatment D|MK-8266 orally twice daily (1 mg in the morning and 0.4 mg 8 hours later) plus placebo to match Treatment E on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266.
16219270|NCT01244035|Drug|Treatment E|MK-8266 0.2 mg orally every 2 hours (total dose of 1.4 mg) plus placebo to match Treatment D on Days 1 through 3. On Day 4, single dose of 1 mg MK-8266.
16219271|NCT01244035|Drug|Treatment F|Placebo to match MK-8266 Treatments D and E orally daily on Days 1 through 3. On Day 4, single dose of placebo to match MK-8266.
16219272|NCT01244022|Procedure|colorectal cancer resection|Open radical resection of colorectal cancer, according to oncological principals, depending on the tumor site
16220926|NCT01231516|Drug|GSK1349572|50mg once daily
16219274|NCT01243996|Drug|Ibuprofen|Treatment with high (20-10-10 mg/kg/day)or standard dose(10-5-5 mg/kg/day) ibuprofen
16219275|NCT01243983|Drug|LX211|"Subjects will be sequentially assigned to one of the following treatment arms in a 1:1 ratio:
~Treatment Arm A: voclosporin 0.4 mg/kg p.o. b.i.d., not to exceed 40 mg p.o. b.i.d.
~Treatment Arm B: placebo p.o. b.i.d.
~Dosage Form:
~• Soft gelatin capsule
~Duration of treatment:
~• 24 weeks"
16219276|NCT01243970|Drug|Phenylephrine|"Infusion dose 50 mcg / minute. On/off regimen in response to blood pressure (BP) readings every minute. Approximative 30 minutes treatment duration. Total dose 50 mcg - 1500 mcg *
~* We will start the infusion after the spinal anaesthetic (see trial design), and while we will monitor cardiac output and BP (for 20 minutes) the surgeons will prep the patient (surgery not started yet). Birth should occur more or less 10-15 minutes after beginning surgery, so this is approximatively 30 minutes after spinal anaesthetic. It is very unlikely that the infusion will run continuously and exceed 1500 mcg."
16219277|NCT01243970|Drug|Ephedrine|"Infusion dose 4mg / minute. On/off regimen in response to blood pressure readings every minute. Approximative 30 minutes treatment duration. Total dose 4 mg - 120 mg. *
~* We will start the infusion after the spinal anaesthetic(see trial design), and while we will monitor cardiac output and BP (for 20 minutes) the surgeons will prep the patient (surgery not started yet). Birth should occur more or less 10-15 minutes after beginning surgery, so this is approximatively 30 minutes after spinal anaesthetic. It is very unlikely that the infusion will run continuously and exceed 120mg."
16219278|NCT01243957|Drug|LY2216684|LY2216684: 18 mg po QD on Days 1, 2, and 3 and Days 25-27
16219279|NCT01243957|Drug|Fluoxetine|Fluoxetine: 60 mg po QD for 7 days (Days 4-10) then 20 mg po QD for 17 days (Days 11-27)
16219280|NCT01243944|Drug|ruxolitinib tablets|Starting dose of 10 mg BID with individualized dose titration ranging from 5 mg QD to 25 mg BID based on safety and efficacy
16219281|NCT01243944|Other|Best Available Therapy (BAT)|Best Available Therapy (BAT) will be selected by the Investigator for each participant. BAT may not include experimental agents (i.e. those not approved for the treatment of any indication) as well as a limited number of other selected drugs in accordance with the protocol-defined requirements.
16219282|NCT01243931|Drug|OCT-guided laser phototherapeutic keratectomy|Preoperative measurements from the OCT are used to assist the calculation in deciding the laser depth settings for removal of anterior corneal opacities and defects in the phototherapeutic PTK procedure. The surgeon uses the OCT data to plan a range of treatment parameters to remove most of the opacity while preserving at least 250 microns of residual corneal stroma.
16219283|NCT01243918|Other|Oxygen therapy delivery systems|T-60 (minutes) : clinical examination, blood gas, electrocardiogram; T0 / First oxygen therapy delivery system: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2; T10 : blood gas; Between T0 and T60 (every 10 minutes): clinical examination, measurement of positive and expiratory pressure and FiO2; T60 / Second oxygen therapy delivery system: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2; T70 : blood gas; Between T60 and T120 (every 10 minutes): clinical examination, measurement of positive and expiratory pressure and FiO2; T120: clinical examination, blood gas, electrocardiogram, measurement of positive and expiratory pressure and FiO2
16219284|NCT01243905|Other|Family psychoeducational therapy plus TAU|Group psychoeducation every two weeks for eight weeks in addition to treatment as usual administered by physicians
16219285|NCT01243905|Other|Treatment as usual|Treatment as usual administered by physicians
16219286|NCT01243892|Device|NuSpin|Device for administration of doses of somatropin.
16219287|NCT01243892|Drug|Somatropin|Somatropin using either NuSpin or Nutropin AQ Pen, as per standard dosing.
16219288|NCT01243879|Other|Stimuli of food smell and vision|60 hours of starvation (fasting) in the presence or absence of visual and odorous food cues
16219289|NCT01243879|Other|No stimuli of food smell and vision|60 hours of starvation (fasting) in the presence or absence of visual and odorous food cues
16219290|NCT01243866|Other|comprehensive dental treatment|Early treatment children were scheduled for comprehensive dental treatment over a 2-month period (from May to June 2007). All test children had their last dental treatment visit within the last 2 weeks of the second treatment month. The follow-up survey was scheduled for each child to be approximately 6-month after their dental last visit. This step was very important to make sure that all children were examined at exactly the same interval between end of treatment and when re-examined at the follow-up examination.
16219291|NCT01243866|Other|Only emergency dental treatment|Regular treatment did not receive any dental treatment in the period when the early children were treated unless they had toothache or dental infection. In that case they were treated for the pain but did not have comprehensive dental treatment
16219292|NCT01243853|Dietary Supplement|Alpha-galactosidase|3 months intervention, daily 3 x 3 capsules alpha-galactosidase enzyme (400 GalU/capsule) or 3 x 3 capsules placebo
16219293|NCT01243827|Drug|carvedilol|carvedilol is administered after randomization at a dose of 10 mg once daily, and if needed, titrated to 15 mg and to a maximum of 20 mg to achieve a clinic BP <140/90 mmHg.
16219294|NCT01243827|Drug|bisoprolol|bisoprolol is administered after randomization at a dose of 2.5 mg once daily, and if needed, titrated to 3.75 mg and to a maximum of 5.0 mg to achieve a clinic BP <140/90 mmHg.
16219295|NCT01243814|Device|hyaluronate intra-articular injection|joint injection in ankle with hyaluronate
16219296|NCT01243814|Device|placebo injection|joint injection with saline solution for placebo
16219297|NCT01243801|Drug|Ketamine|Intravenous ketamine 0.5mg/kg(induction of anesthesia)and 0.25 mg/kg/h for 48h Epidural Ketamine 0.5 mg/kg(induction of anesthesia)and 0.25 mg/kg/h for 48h
16219298|NCT01243788|Drug|Salmeterol/Fluticasone Propionate|Salmeterol/Fluticasone 50/500ug twice daily Duration:12 weeks
16219299|NCT01243775|Drug|Belotaxel|60 mg/m2 3 weekly (day 1)
16219300|NCT01243775|Drug|Belloxa|70 mg/m2 3 weekly (day 2)
16219301|NCT01243762|Drug|dalotuzumab|Administered intravenously (IV) once weekly in 28-day cycles for a maximum of 6 months of study therapy
16219302|NCT01243762|Drug|MK-0752|Administered orally (PO) weekly in 28-day cycles for a maximum of 6 months of study therapy
16219303|NCT01243762|Drug|ridaforolimus|Administered PO daily for 5 consecutive days per week in 28-day cycles for a maximum of 6 months of study therapy
16219304|NCT01243762|Drug|MK-2206|Administered PO weekly in 28-day cycles for a maximum of 6 months of study therapy
16220927|NCT01231516|Drug|Raltegravir|400mg twice daily
16219305|NCT01243736|Drug|Combination Prep|"combination bowel preparation, which consists of:
~drinking 2-liters (8 cups) of polyethylene glycol starting at 7 p.m. the night prior to the capsule endoscopy test;
~drinking a teaspoon of simethicone 20 minutes prior to the capsule endoscopy test;
~drinking a teaspoon of metoclopramide 20 minutes prior to the capsule endoscopy test;
~lying on your right side for 30 minutes following the swallowing of the capsule endoscope."
16219306|NCT01243723|Drug|Eductyl suppository|One suppository every morning during 21 days
16219307|NCT01243723|Drug|Placebo suppository|One suppository every morning during 21 days
16219308|NCT01243710|Device|Taurolidine with heparin (500 units/ ml)|Central venous catheter will be locked (the designated volume required to fill the dead space) with taurolidine with heparin after each dialysis session. The control arm will be locked with heparin as is current practice.
16219309|NCT01243697|Drug|desogestrel|Tablets of 75 µg, once daily during 112 days
16219310|NCT01243684|Device|DTI - Diffusor Tensor Imaging|Radiology intervention
16219311|NCT01243671|Biological|Adalimumab|
16219312|NCT01243658|Drug|Oxytocin|Oxytocin
16219313|NCT01243658|Other|placebo|placebo
16219314|NCT01243645|Behavioral|biofeedback training|
16219315|NCT01243632|Drug|Prolonged 6-hr infusion of gemcitabine|Gemcitabine 250 mg/m2 in prolonged 6 hr infusion on day 1 and 8, and cisplatin at 75 mg/m2 on day 2 of 3 week cycle, for 4-6 cycles
16219316|NCT01243619|Drug|3'-deoxy-3'-(18) F-fluorothymidine|Radio-tracer for tumor imaging
16219317|NCT01243606|Behavioral|Single Diagnosis Treatment Protocol|SDPs include: Managing Social Anxiety: A CBT Approach; Mastery of Anxiety and Panic-IV; Mastery of Anxiety and Worry-II; and Obsessive-Compulsive Disorder: A CBT Approach
16219318|NCT01243606|Behavioral|Unified Protocol (UP)|The UP is designed to help patients learn how to confront and experience uncomfortable emotions and learn how to respond to their emotions in more adaptive ways. Individual treatment sessions will be conducted by experienced clinicians who will be trained in the administration of this protocol. A workbook will be provided to each patient as part of this manualized treatment. Treatment and session length of the UP will be matched to the SDPs for each principal diagnosis (see description above).
16219319|NCT01243593|Procedure|Transversus Abdominis Plane Block|A block needle will be advanced in a medial to lateral direction until the tip is visualized in the transversus abdominis plane. After negative aspiration 0.4 ml/kg of bupivacaine 0.25% with 1:200 000 epinephrine will be injected. The total dose of bupivacaine will not exceed 2 mg/kg and the total volume will not be more than 20 ml.
16219320|NCT01243593|Procedure|Standard Anesthesia|Local field infiltration with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg before skin incision.
16219321|NCT01243580|Drug|Ortho-Cyclen|Ortho-Cyclen is an oral contraceptive containing 35 µg of EE and 250 µg of norgestimate (NGM) in a 21 - 7 day regimen.
16219322|NCT01243580|Drug|AG200-15|AG200-15 is a transdermal contraceptive delivery system delivering 100 - 120 mcg of LNG and 25 - 30 mcg EE
16219323|NCT01243567|Drug|bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution|Bimatoprost 0.03%/timolol 0.5% combination ophthalmic solution (GANfort®) administered to each eye requiring treatment, once daily in the evening for 3 months.
16219324|NCT01243567|Drug|latanoprost 0.005% ophthalmic solution|Latanoprost 0.005% ophthalmic solution (Xalatan®) administered to each eye requiring treatment, once daily in the evening for 3 months.
16219325|NCT01243554|Behavioral|Exercise|Exercise training at the hospital
16219326|NCT01243541|Procedure|cryotherapy|Patients wear an Elasto-Gel cold glove and sock
16219327|NCT01243541|Other|questionnaire administration|Ancillary studies
16219328|NCT01243541|Procedure|quality-of-life assessment|Ancillary studies
16219329|NCT01243541|Procedure|management of therapy complications|In this therapeutic study, cold therapy is administered with an Elasto-Gel cold glove and sock (study device) that will be worn on your right hand and foot or your left hand and foot. The study device is a glycerine-based gel cold pack shaped like a mitten or sock with a cloth-like fabric kept at a constant temperature. The study device is not known to cause any major adverse affects and it is considered of non-significant risk. If you choose to participate in this study, you will be asked to wear a glove and sock at each paclitaxel infusion (4 treatments total). We hope the use of this study device will prevent or significantly reduce the onset and potential severity of paclitaxel-induced peripheral neuropathy and nail problems.
16219330|NCT01243541|Procedure|assessment of therapy complications|Study Treatment Assessment You will be asked permission for pictures to be taken of only your hands and feet. This is to have a visual documentation of symptom development during your treatment. This will be done at all six time points before you begin chemotherapy that day.
16219331|NCT01243528|Other|Laboratory values|Laboratory values which represent nutritional status
16219332|NCT01243515|Device|Non-Invasive Central Venous Pressure monitor|An adhesive patch (connected to the Mespere NICVP monitor) is placed on the neck of the subject, to determine if the CVP values displayed by the device correlates with CVP values obtained by physical examination (standard clinical practice)
16219333|NCT01243515|Procedure|Physical examination of jugular vein|Physicians assess CVP using the jugular vein of the subject
16219334|NCT01243502|Drug|0.01% CT327 (or placebo)|Cream (10 g) was applied at an even thickness over a test area on the back of 10 x 10 cm to give an exposure of 1000 μg/dm2.
16219335|NCT01243502|Drug|0.001% CT327 (or placebo)|Cream (10 g) was applied at an even thickness over a test area on the back of 10 x 10 cm to give an exposure of 100 μg/dm2.
16219336|NCT01243489|Other|compliance supporting measures|"Patients will be treated for a total of 12 months, 6 months without and 6 months with compliance supporting measures. Patient can choose between an information service Leben mit CML or the use of a daily diary"
16219337|NCT01243476|Drug|Lenalidomide|Treatment with Revlimid (lenalidomide), oral use, 5 mg daily during study treatment (104 weeks).
16219338|NCT01243476|Other|Placebo|Placebo, oral use, daily during study treatment (104 weeks)
16219339|NCT01243450|Drug|Tretinoin|Treatment of acne
16219340|NCT01243450|Drug|placebo|treatment of acne
16219341|NCT01243437|Drug|ciprofloxacin|"For adults and children aged > 15 years: 500 mg orally every 12 hours for 10 days or until the patient has been fever-free for 24 hours, whichever is longer;
~For children aged 8-15 years: 15 mg/kg (maximum 500 mg per dose) orally every 12 hours for 10 days or until the patient has been fever-free for 24 hours, whichever is longer."
16220978|NCT01231230|Drug|Salmeterol|50 mcg salmeterol once
16219342|NCT01243437|Drug|doxyxcycline|"For adults and children weighing 45 kg or more: 200 mg orally one time as an initial loading dose, followed by 100 mg orally every 12 hours for 10 days or until the patient has been fever-free for 24 hours, whichever is longer;
~For children weighing less than 45 kg: 4.4 mg/kg orally one time as an initial loading dose, followed by 2.2 mg/kg orally every 12 hours for 10 days or until the patient has been fever-free for 24 hours, whichever is longer."
16219343|NCT01243424|Drug|linagliptin|linagliptin tablets 5mg QD
16219344|NCT01243424|Drug|glimepiride|glimepiride over-encapsulated tablet 1-4 mg QD
16219345|NCT01243424|Drug|linagliptin placebo|linagliptin placebo
16219346|NCT01243424|Drug|glimepiride placebo|glimepiride placebo
16219347|NCT01243411|Biological|AA4500|2 injections separated by at least 24 hours but not more than 72 hours, repeated after 42 days (± 5 days) for up to 4 treatment cycles (ie, total of up to 8 injections per subject)
16219348|NCT01243398|Procedure|quality-of-life assessment|
16219349|NCT01243385|Drug|Metformin|Metformin Lifelong follow-up at a target dose of 2 x 1000 mg daily Until progression, unacceptable toxicity or refusal
16219350|NCT01243372|Genetic|mutation analysis|
16219351|NCT01243372|Other|laboratory biomarker analysis|
16219352|NCT01243359|Drug|sunitinib malate|Given PO
16219353|NCT01243359|Biological|bevacizumab|Given IV
16219354|NCT01243359|Other|pharmacological study|Correlative studies
16219355|NCT01243359|Other|laboratory biomarker analysis|Correlative studies
16219356|NCT01243359|Other|fluorine F 18 fluorothymidine|Undergo FLT PET/CT
16219357|NCT01243359|Procedure|positron emission tomography|Undergo FLT PET/CT
16219358|NCT01243359|Procedure|computed tomography|Undergo FLT PET/CT
16219359|NCT01243346|Drug|Crenolanib besylate (CP-868,596-26), Dose: 140mg BID|Highly potent inhibitor of both PDGFR receptors alpha and beta
16219360|NCT01243333|Radiation|[F-18]fluorodeoxyglucose|Undergo PET scans with [F-18]fluorodeoxyglucose
16219361|NCT01243333|Radiation|[F-18]fluorothymidine|Undergo PET scans with fluorine [F-18]fluorothymidine
16219362|NCT01243333|Procedure|Positron Emission Tomography|Undergo PET scans with 3 radiotracers (fludeoxyglucose F 18, fluorine F 18 fluorothymidine, and water O-15)
16219363|NCT01243333|Radiation|Water O-15|Undergo PET scans with water O-15 tracers
16219364|NCT01243320|Drug|10ppm Oral Silver Particle|Silver nanoparticles at 10ppm
16219365|NCT01243320|Drug|32ppm Oral Silver Particle|Silver nanoparticles at 32ppm
16219366|NCT01243307|Drug|CT327 (or placebo) followed by placebo (or CT327)|"During treatment/testing period 1, subjects will apply 0.25 g CT327 (or placebo) to 4 test fields of skin (2 on their arms and 2 on their legs) twice daily, 12 hours apart for a total of 7 applications.
~During treatment/testing period 2, subjects will apply 0.25 g placebo (or CT327) to 4 different test fields of skin (2 on their arms and 2 on their legs) twice daily, 12 hours apart for a total of 7 applications."
16219367|NCT01243294|Device|SS|New ostomy appliance (SS) is tested in 10 ± 2 days and the degree of leakage under the baseplate is measured and compared to SenSura.
16219368|NCT01243294|Device|SenSura|New ostomy appliance (SS) is tested in 10 ± 2 days and the degree of leakage under the baseplate is measured and compared to SenSura.
16219369|NCT01243281|Drug|PEG-IFN and entecavir|The patients will be randomized in approximately 1:1 ratio into one of 2 treatment regimens; to receive PEG-IFN alpha-2b (1.5 microgram/kg/week) plus entecavir (0.5 mg/day) or PEG-IFN alpha-2b (1.5 microgram/kg/week) alone for 48 weeks by using pre-generated randomization schedule.
16219370|NCT01243268|Drug|Twynsta tablet|Telmisartan and Amlodipine T40/A5, T80/A5 and T40/A10
16219371|NCT01243242|Drug|Metadoxine (MG01CI)|MG01CI 1400 mg, that will be taken daily by the patients for a duration of 6 weeks.
16219372|NCT01243216|Device|Ultrasound|Ultrasound examination of the lumbar spine. The level of the lumbar interspace will be determined by the oblique/sagittal method. The transverse method will be used to determine the best lumbar interspace and the distance from the skin to the target (epidural space or intrathecal space)
16219373|NCT01243203|Drug|Champix|Days 1 - 3: 0.5 mg once daily (1 table each day) Days 4 - 7: 0.5 mg twice daily (1 in the morning and 1 in the evening) Days 8 - 12 weeks 1.0 mg twice daily (1 in the morning and 1 in the evening)
16219374|NCT01243190|Drug|Ofatumumab|Loading first dose 300 mg by vein on Day 1 of Cycle 1; and full dose 1000 mg over 4 hours 1 time each week for 7 additional weekly doses (8 doses).
16219375|NCT01243177|Drug|Lacosamide|"Lacosamide:
~Strengths: 50 mg / 100 mg
~Form: tablets
~Dosage: total daily target dose of 200 mg, 400 mg or 600 mg. 1 dose reduction was allowed from either 600 mg to 500 mg or from 400 mg to 300 mg total daily dose
~Duration: up to 118 weeks"
16219376|NCT01243177|Drug|Carbamazepine-Controlled Release|"Carbamazepine-CR:
~Strengths: 200 mg
~Form: tablets
~Dosage: total daily target dose of 400 mg, 800 mg or 1200 mg. 1 dose reduction was allowed from either 1200 mg to 1000 mg or from 800 mg to 600 mg total daily dose
~Duration: up to 118 weeks"
16219377|NCT01243164|Other|Wheelchair Skills Training Program|The Wheelchair Skills Training Program will be administered in 2, 1 hour sessions.
16219378|NCT01243151|Biological|PF-04950615 (RN316)|Infusion every week
16219379|NCT01243151|Biological|PF-04950615 (RN316)|Infusion every week
16219380|NCT01243151|Biological|PF-04950615 (RN316)|Infusion every week
16219381|NCT01243151|Biological|PF-04950615 (RN316)|Infusion every week
16219382|NCT01243151|Biological|PF-04950615 (RN316)|Infusion every week
16219383|NCT01243125|Drug|NVC-422, 0.2%|0.2% NVC-422 (sterile), 25 ml instilled and retained in catheter for 15 min, 2x/day; 8 treatments administered over a 26 day period
16219384|NCT01243125|Drug|Sterile normal saline, 0.9%|Saline (sterile), 25 ml instilled and retained in catheter for 15 min, 2x/day; 8 treatments administered over a 26 day period
16219385|NCT01243112|Drug|1% Lidocaine with Epinephrine (1:100,000)|0.2ml Intradermal injection once.
16219386|NCT01243112|Drug|0.25% Bupivacaine with Epinephrine (1:200,000)|0.2ml Intradermal injection once.
16219387|NCT01243112|Drug|0.5% Lidocaine, 0.125 Bupivacaine, and epi (1:150,000)|0.2ml Intradermal injection once.
16219388|NCT01243112|Drug|1% Lidocaine, 0.5% Bupivacaine, and epinephrine (1:150,000)|0.2ml Intradermal injection once.
16219389|NCT01243086|Drug|Ranibizumab|Intra-vitreal injections of 0.5mg/0.05 mL dosage, injected at months 0, 1, and 2. For those requiring additional injections, patients will receive monthly treatment up to a maximum of 6 months total.
16219390|NCT01243086|Drug|OZURDEX|OZURDEX injection of 0.7mg dosage at months 0 with follow up for a total of 6 months.
16219391|NCT01243073|Drug|Imetelstat|
16219392|NCT01243060|Drug|Almorexant|100mg
16219393|NCT01243060|Drug|Almorexant|200mg
16219394|NCT01243060|Drug|Zolpidem 10mg|10mg
16219395|NCT01243060|Drug|Placebo|One-time dose of Placebo
16219396|NCT01243047|Drug|Chemotherapy|Erlotinib, Oxaliplatin, Capecitabine
16219397|NCT01243008|Drug|Application of SHB001|"Cohort 1: Application of SHB001 on the skin of right thigh
~Cohort 2:
~Application of SHB001 on the skin of right thigh
~punch biopsies of treated skin areas"
16219398|NCT01242995|Procedure|Endoscopic Retrograde Cholangiopancreatography (ERCP)with Cholangiopancreatoscopy using the thin scope|Endoscopic Retrograde Cholangiopancreatography (ERCP) with cholangiopancreatoscopy using the thin scope system.
16219399|NCT01242982|Procedure|Closed reduction and fixation with 2 pins|Closed reduction and fixation with 2 antegrade intramedullary Kirschner wires. Cast for 2 weeks. Control after 2 and 5 weeks. Thereafter a control after 3,6 and 12 months
16219400|NCT01242982|Procedure|Reduction and Plaster of Paris|Closed reduction in local anesthesia and a Plaster of Paris for max. 3 weeks. Control after 1 and 3 weeks, thereafter control after 3,6 and 12 months
16219401|NCT01242956|Behavioral|verum group|video-based training after stroke
16219402|NCT01242956|Behavioral|Placebo group|non-video group
16219403|NCT01242943|Drug|131I-L19SIP Radioimmunotherapy (RIT)|"Dosimetric evaluation with 131I-L19SIP will be performed to assess eligibility for Radioimmunotherapy.
~Phase I: Patients eligible for Radioimmunotherapy will receive escalating doses of therapeutic 131I-L19SIP administration (intravenously) at the following dosages (expressed in mCi/m2): 111, 139 and 167."
16219404|NCT01242930|Drug|Imetelstat (7.5 mg/kg)|Imetelstat 7.5 mg/kg as a 2-hour intravenous infusion (± 10 minutes) on Days 1 and 8 of a 28-day cycle; the Day 8 dose will be omitted in patients with a prior history of bone marrow or stem cell transplant.
16219405|NCT01242930|Drug|lenalidomide standard of care|Patients who are receiving lenalidomide as maintenance therapy upon enrollment as part of their treatment regimen may remain on this therapy during trial participation, provided that they have received this treatment for a minimum of 3 months and demonstrate evidence of stabilization of their response.
16219406|NCT01242930|Drug|Imetelstat (9.4 mg/kg)|Imetelstat 9.4 mg/kg as a 2-hour intravenous infusion (± 10 minutes) on Days 1 and 8 of a 28-day cycle; the Day 8 dose will be omitted in patients with a prior history of bone marrow or stem cell transplant.
16219407|NCT01242917|Drug|CCX-354-C|200mg film-coated tablets once daily for 12 weeks + Methotrexate
16219408|NCT01242917|Drug|Placebo|Placebo film-coated tablets twice daily for 12 weeks + methotrexate
16219409|NCT01242917|Drug|CCX354-C|100mg film-coated tablets twice daily for 12 weeks + methotrexate
16219410|NCT01242904|Drug|bimodal solution|200 mL of 30% glucose infused into the abdomen by the patient each morning for 6 weeks, added to the daytime dwell of approximately 2000 mL icodextrin that has been infused by the cycler
16219411|NCT01242904|Drug|icodextrin|200 mL of icodextrin infused into the abdomen by the patient each morning for 6 weeks, added to the daytime dwell of approximately 2000 mL icodextrin that has been infused by the cycler
16219412|NCT01242891|Device|EXCOR® Pediatric Ventricular Assist Device|Extracorporeal Ventricular Assist Device
16219413|NCT01242865|Behavioral|Attention and Interpretation Therapy|"Participants will receive a copy of the book, Train Your Brain Engage Your Heart Transform Your Life along with three handouts summarizing the contents of the book."
16219414|NCT01242852|Procedure|Office hysteroscopy (in combination with a 'Saline Infusion Sonography'(SIS))|Routine fertility work-up, added up with diagnostic tests. In 5 research centers the extra tests consist of SIS & hysteroscopy (HY). In the other research hospitals it consists of only a HY. The HY examination will be scheduled on Day 3-12 of a cycle. It will be performed in an outpatient setting with a vaginoscopic approach. A 5-mm diameter continuous flow hysteroscope and a 30º direction of view will be used. The uterus will be inspected methodically a endometrial biopsy obtained and the findings recorded into a standardized form. Intrauterine pathology is defined as septum, endometrial polyp, submucous myoma, adhesions & endometritis. These will be treated, using scissors, Versapoint, grasping forceps, polyp snare or antibiotics. In 5 of the research hospitals, 1 week prior to the HY, also a SIS will be performed. Via a catheter saline solution will be infused into the uterine cavity as distention media. The findings at the following sonography will be standardized recorded.
16219415|NCT01242839|Device|CACICOL20|CACICOL20 is a solution of dextran & poly(carboxymethylglucose sulphate)in physiological salt serum. CACICOL20 is presented in 0.33 mL strip. One drop is instilled at each application to impregnate cornea.
16219416|NCT01242839|Device|Placebo|It is the placebo of CACICOL20, containing dextran in physiological serum salt. It is presented, like CACICOL20, in a 0.33 mL strip. One drop is delivered at each application.
16219417|NCT01242826|Drug|biphasic insulin aspart 50|A single dose of 0.3 U/kg BIAsp 50 for subcutaneous (under the skin) injection
16219418|NCT01242813|Drug|ACZ885|
16219419|NCT01242800|Procedure|palliative surgery|Undergo standard palliative surgery
16219420|NCT01242800|Procedure|therapeutic conventional surgery|Undergo early surgery
16219421|NCT01242800|Radiation|palliative radiation therapy|Undergo standard palliative radiotherapy
16219422|NCT01242800|Radiation|radiation therapy|Undergo radiotherapy
16219423|NCT01242787|Drug|LB80380|Optimal dose of LB80380, by oral for 48 weeks (optimal dose will be chosen early 2011 based on the results of LG-BVCL007 study)
16219424|NCT01242787|Drug|Entecavir 0.5 mg|Entecavir 0.5 mg, by oral for 48 weeks
16219425|NCT01242774|Drug|Panobinostat|Oral administration of panobinostat given 3 times a week (administered on weeks 2 and 3 of a 4 week cycle) in combination with induction chemotherapy (idarubicin and cytarabine.
16219426|NCT01242748|Drug|Degarelix|The degarelix doses were administered by subcutaneous (s.c.) injections into the abdominal wall. In the main CS35 trial, a starting dose of 240 mg degarelix was administered on Day 0. One month later a maintenance dose of 480 mg was administered. This was repeated after 4, 7, and 10 months (ie a total of 5 administrations in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the degarelix treated participants continued to receive degarelix 480 mg s.c. treatment every three months.
16219649|NCT01241071|Other|myofascial treatment|myofascial release techniques of different muscles implicated in low back pain
16219427|NCT01242748|Drug|Goserelin acetate|The goserelin doses were administered by subcutaneous (s.c.) implants into the abdominal wall. In the main CS35 trial, an initial dose of 3.6 mg goserelin was administered on Day 0. One month later a subsequent dose of 10.8 mg was administered and this was repeated after 4, 7, and 10 months (ie a total of 5 implants in the main trial). In the CS35A extension trial, the participants received the same treatment as in the main trial ie the goserelin treated participants continued to receive goserelin acetate 10.8 mg s.c. implants every three months.
16219428|NCT01242735|Behavioral|Aerobic exercise|12-week moderate-intensity behavioral exercise intervention. Weekly sessions with an exercise physiologist who will also assign weekly exercise goals.
16219429|NCT01242735|Behavioral|Health and Wellness|12-week health and wellness education control. Weekly sessions about 12 different topics related to OCD, led by an OCD expert.
16219430|NCT01242722|Device|CRT-D|Cardiac pacing via a pulse generator and implanted intracardiac leads
16219431|NCT01242696|Procedure|Coronary artery stenting|Coronary artery stenting with drug eluting stents
16219432|NCT01242683|Behavioral|Vivamos Activos Fair Oaks Program|"Comparison of Case-management vs. Case-management plus Home Visits vs. Usual Primary Care.
~Case-management: Five 60 minute individual and 15 90 minute group sessions devoted to behavioral strategies to facilitate weight loss conducted by a health educator.
~Home-visits: Seven home visits provided by a community health worker to provide life-style/environmental support for behavior change to facilitate weight loss.
~Usual primary care: Usual care provided at health center that is available to participants in all three study arms."
16219433|NCT01242670|Biological|Ross River Virus Vaccine|Ross River Virus Vaccine (Formalin Treated, UV Inactivated, Vero Cell-Derived) with Aluminum Hydroxide Adjuvant
16219434|NCT01242657|Behavioral|Physical Activity Module|"Participants were provided pedometers in order to track specific Step Goals, which were defined for male or female participants. In addition, each participant recorded other forms of physical activity in a Challenge Log."
16219435|NCT01242657|Behavioral|Not On Tobacco (N-O-T) Program|Not On Tobacco (N-O-T) Program, a proven teen smoking cessation program
16219436|NCT01242644|Device|pain pump containing ropivacaine|30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100mL of ropivacaine (0.5%) administered at 4 mL/hour
16219437|NCT01242644|Device|saline pain pump with injectable medication|30mL of ropivacaine(0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected plus a pain pump containing 100-mL of normal saline administered at 4 mL/hour
16219438|NCT01242644|Drug|ropivacaine, ketorolac , morphine sulfate|30mL of ropivacaine (0.5%), 30mg of ketorolac and 8mg of morphine sulfate injected
16219439|NCT01242631|Drug|Everolimus|Everolimus 10 mg orally per day.
16219440|NCT01242618|Biological|engineered nasal cartilage graft|implantation of engineered nasal cartilage grafts in the alar lobule
16219441|NCT01242605|Drug|selumetinib|The starting dose of selumetinib will depend on the cohort. The first dose of selumetinib to be studied will be 75 mg twice daily (bd). Selumetinib will be taken every day (continuously) either once or twice a day, depending on the dose. Treatment with selumetinib may continue until disease progression.
16219442|NCT01242605|Drug|gemcitabine|gemcitabine: taken in combination with cisplatin will be given at 1000 mg/m*2 in 250 - 500 ml 0.9% saline over 30 minutes by intravenous infusion on days 1, and 8 of each 21-day cycle for eight cycles in total
16219443|NCT01242605|Drug|cisplatin|cisplatin: 25 mg/m*2 in 1000 ml 0.9% saline given over 1 hour followed by 500mls 0.9% saline over 30 minutes followed by gemcitabine on days 1, and 8 of each 21-day cycle for eight cycles in total
16219444|NCT01242592|Drug|Anti-Tuberculosis Treatment|
16219445|NCT01242579|Drug|Maraviroc/Dapivirine Gel|Vaginal gel containing 2.5g - Maraviroc 0.1%, Dapivirine 0.05%
16219446|NCT01242579|Drug|Dapivirine Vaginal Gel|Dapivirine vaginal gel containing 2.5g
16219447|NCT01242579|Drug|Maraviroc Vaginal Gel|Maraviroc vaginal gel containing 2.5g
16219448|NCT01242579|Drug|Matching Placebo Gel|Matching placebo gel containing 2.5g
16219449|NCT01242566|Drug|Temozolomide|orally 150-200 mg/m2/day for 5 consecutive days every 4 week
16219450|NCT01242527|Drug|placebo|4 capsules (1g) daily for 12 weeks
16219451|NCT01242527|Drug|omefas|2 capsules (1g) + 2 placebo daily for 12 weeks
16219452|NCT01242527|Drug|omefas|3 capsules (1g) + 1 placebo daily for 12 weeks
16219453|NCT01242527|Drug|omefas|4 capsules (1g)daily for 12 weeks
16219454|NCT01242514|Drug|Fostamatinib|Fostamatinib 100mg twice daily
16219455|NCT01242514|Drug|Fostamatinib|Fostamatinib 150mg once daily
16219456|NCT01242514|Drug|Fostamatinib|Fostamatinib 100mg once daily
16219457|NCT01242501|Behavioral|60 Minute HIV/STI risk reduction counseling.Single 60 min Social Cognitive Theory-based counseling.|Single session risk reduction counseling delivered in STI clinic settings in South Africa.
16219458|NCT01242501|Behavioral|20-Min education session|Patients receive a single 20 min education session for STI/HIV informationSingle brief HIV/STI education only session for men and women receiving sexually transmitted infection clinic services in South Africa. Includes only brief educational information on sexual risks for HIV infection in a single face-to-face counseling session.
16219459|NCT01242488|Biological|CDP6038|60 mg subcutaneously (sc) at Weeks 0, 2, 4 6, 8, and 10
16219460|NCT01242488|Biological|CDP6038|120 mg sc at Weeks 0, 2, 4 6, 8, and 10
16219461|NCT01242488|Biological|CDP6038|240 mg sc at Weeks 0, 2, 4 6, 8, and 10
16219462|NCT01242488|Biological|Tocilizumab (Actemra or RoActemra)|8 mg/kg intravenously (iv) at Weeks 0, 4 and 8
16219463|NCT01242488|Biological|CDP6038|60 mg sc at Weeks 0, 4 and 8
16219464|NCT01242488|Biological|CDP6038|240 mg sc at Weeks 0, 4 and 8
16219465|NCT01242488|Biological|CDP6038|120 mg sc at Weeks 0, 4 and 8
16219466|NCT01242488|Other|Placebo sc|0.9% Sodium chloride for injection at Weeks 0, 2, 4 6, 8, and 10
16219467|NCT01242488|Other|Placebo sc|0.9% Sodium chloride for injection at Weeks 2, 6 and 10
16219468|NCT01242488|Other|Placebo iv|0.9% Sodium chloride for injection at Weeks 0, 4 and 8
16219469|NCT01242475|Biological|C-Tb|The C-Tb agent is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearms according to a double blind randomisation scheme
16219568|NCT01241669|Drug|E5555|Drug: Oral E5555 400 mg/matching placebo, oral metformin 500 mg, iohexal 20 mL intravenous (IV), and para-aminohippuric acid (PAH) 7 mg/kg IV.
16219470|NCT01242475|Biological|2 TU Tuberculin PPD RT 23 SSI|The 2TU Tuberculin PPD RT 23 SSI agent is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearms according to a double blind randomisation scheme
16219471|NCT01242462|Procedure|Conventional Pressure Controlled SIMV|Initial ventilatory settings per clinical physician's discretion-tcCO2 & Saturation (SAT) monitoring. Adjust vent setting approximately every 15min with a goal of: SAT 88-95%, tcCO2 45-55, pH greater than or equal to 7.25. Once goals reached, ventilatory strategy will crossed over to other intervention.
16219472|NCT01242462|Other|Mid-frequency Ventilation|Ventilatory parameters include: max possible rate between 61-150 breaths/min; Shortest inspiration time (Ti) and expiration time (Te), but completed inspiration and expiration on pulmonary graphics. Stepwise weaning of PIP by 1 cm H20 to maintain tcCO2 at baseline. If measured PEEP - delivered PEEP generated is >/= to 1cm H2O, PEEP is reduced to baseline value. Adjustments will be made to PIP, then rate for pH and CO2 changes; FiO2, then PIP for FiO2 changes. Target goal blood gas parameters (same as baseline) Saturations 88-95%; tcCO2 45-55 mmHG; pH >/= 7.25. Maximum period of 2 hours. When goals met, or 2 hours in period, reverted back to SIMV at baseline settings
16219473|NCT01242449|Drug|Trastuzumab|Initial dose 8 mg/kg i.v. Subsequently, 6 mg/kg i.v. at intervals of 3 weeks
16219474|NCT01242449|Drug|Vinorelbine|Initial dose 70 mg/m2 on days 1 and 8 (capsules) If well tolerated, subsequently 90 mg/m2 on days 1 and 8. Capsule on day 1 to be taken at the hospital, and on day 8 at home.
16219475|NCT01242436|Procedure|intravenous contrast administration|"The additional burden is restricted to a WB-DWI scan before and during therapy.
~MRI is a technique based on magnetic fields and do not require the use of ionizing radiation. Because of the strong magnetic field, a few precautions should be taken. This means that all metal and magnetized objects must be removed from the patient before entering the MRI room. Patients with a pacemaker, a cardiac defibrillator or other implanted conductor/prosthesis are for this reason not eligible for the study.
~During the examination, an intravenous will be administered. In most cases, patients do not experience any discomfort and the use of this contrast agent is part of the clinical routine."
16219476|NCT01242423|Device|extracorporeal shockwave therapy|ESWT is administered as a one-off treatment on the wound surfaces within 24 hours of a 2nd degree burn trauma and immediately after an intraoperative skin graft excision procedure. A defocused sound head is orthogradely applied to the burn wound or the donor site. 100 impulses/cm² is administered at 20 seconds per cm². The defocused sound head is placed on the wound along with a sterile gel (Lavaseptgel®, Octenidingel®) and a sterile protection foil. The shockwaves deployed are not at an energy density that is painful. This single application of ESWT is followed by routine dressing using Mepitel® in combination with Polyhexanid/Octenidin®.
16219477|NCT01242410|Device|Silicon ring (Arabin Cervical Pessary)|Vaginal pessaries CE 0482 MED / CERT ISO 9003 /EN 46003
16219478|NCT01242397|Device|CRT pacing|The chronic effect of CRT pacing on the degree of MR in pts with severe-to-moderate or severe functional MR. The treatment being studied is CRT pacing therapy with standard of care LV lead placement. Patients will be randomized to CRT pacing ON vs. OFF and followed for a total of up to 8 months. This includes two 3-month crossover periods for each pacing modality (CRT ON and CRT OFF) and a 6-week washout period between these periods.
16219479|NCT01242384|Device|Device: Silicon ring (Arabin Pessary)|Placement of a silicon pessary in the vagina, around the cervix.
16219480|NCT01242371|Dietary Supplement|Probiotic Supplement|Probiotic Supplement 1 tablet by mouth daily
16219481|NCT01242371|Dietary Supplement|Identical-appearing Placebo|Probiotic identical placebo 1 tablet by mouth daily
16219482|NCT01242358|Device|Capnography|Capnographic monitoring
16219483|NCT01242358|Device|Standard monitoring|Standard monitoring
16219484|NCT01242345|Device|Capnography|Monitoring of the capnography curve for early detection of apnea
16219485|NCT01242332|Drug|Pregabalin|75 mg po 2 hrs before surgery
16219486|NCT01242319|Behavioral|HeartAge intervention|Computerized kiosk in waiting room with HeartAge risk calculator, PDA based decision support tool regarding hyperlipidemia management, website and tool box with coronary risk reduction tools for smoking cessation, diet and exercise, medication adherence
16219487|NCT01242306|Drug|intracoronary infusion of acetylcholine|Acetylcholine will be infused at a concentration of 140 microg/minute, over a period of 2 minutes, yielding estimated intracoronary concentrations of 10(-5)mol/L, with the assumption of a flow rate of 80mL/min). All infusions will be delivered at a constant rate using an infusion pump. Subsequently, in order to evaluate the endothelium-independent vasomotor response, 2mg of isosorbide dinitrate or bolus 250microg of nitroglycerine will be infused by intracoronary bolus in all subjects. The response to nitrate will be recorded 1 minute after the bolus. A 3-min period will be allowed to elapse between each drug infusion.
16219488|NCT01242293|Other|0.9% Saline with glucose 5%|intravenous hydration at a rate of 125 ml per hour during labor
16219489|NCT01242293|Other|Ringer lactate|intravenous hydration at a rate of 250 ml per hour during labor
16219490|NCT01242293|Other|Ringer lactate - Controls|intravenous hydration at a rate of 125 ml per hour during labor
16219491|NCT01242280|Device|Stent|Self-expandable esophageal stent (SX-Danis, Czesc Republic).
16219492|NCT01242280|Device|Tamponade|Sengstaken-Blakemore tube
16219493|NCT01242267|Drug|Thalidomide+Melphalan +Bortezomib+stem cell transplant|Five days prior to transplant, the patient starts thalidomide. Dose range will be from 400mg for 5 days, to 1000mg for 5 days. Thalidomide dose is increased after groups of 3 to 6 patients have been treated. 4days before the transplant and again on the day before the transplant the patient will be given bortezomib (VELCADE) intravenously at a dose of 1.6 mg/m2 (mg/m2 means that the dose will be calculated based on the patient's height and weight). 2 days before transplant the patient will be given melphalan 200 mg/m2 intravenously. Dexamethasone is given before the VELCADE and the melphalan.
16219494|NCT01242254|Biological|Intravitreal injection of KH902|0.5 mg 2.0 mg once per 4 weeks during fixed dosing phase once as needed during extended treatment phase
16219495|NCT01242241|Drug|Propofol|Each Obese child/subject in this group will receive a predetermined dose of propofol ranging from 1.0mg/kg to 4.25mg/kg to induce loss of consciousness depending on the response (presence or absence of lash reflex) of the preceding patient to his/her assigned dose (biased coin design)
16219569|NCT01241669|Drug|E5555|Drug: Oral E5555 100 mg/matching placebo, oral metformin 500 mg, iohexal 20 mL intravenous (IV), and para-aminohippuric acid (PAH) 7 mg/kg IV bolus.
16220284|NCT01236300|Device|Cellvizio needle-based Confocal Laser Endomicroscopy (nCLE) system|
16219496|NCT01242241|Drug|Propofol|This arm of patients(non-obese)will act as the control group for the obese children. Each non-obese child/subject will receive a predetermined dose of propofol from a range of 1.0mg/kg to 4.25mg/kg depending on the response of the previous patient to their assigned dose( biased coin design)
16219497|NCT01242228|Drug|ipragliflozin|oral
16219498|NCT01242228|Drug|DPP-4 inhibitor|oral
16219499|NCT01242215|Device|ipragliflozin|oral
16219500|NCT01242215|Drug|Placebo|oral
16219501|NCT01242215|Drug|Sulfonylurea|oral
16219502|NCT01242202|Drug|ipragliflozin|oral
16219503|NCT01242202|Drug|alpha glucosidase inhibitor|oral
16219504|NCT01242176|Drug|BI 10773 XX (Trial Formulation 2)|one single dose tablet in the morning
16219505|NCT01242176|Drug|BI 10773 (Final Formulation)|one single film-coated tablet in the morning
16219506|NCT01242150|Device|NCPAP by helmet|The infant helmet (Castar Starmed© Mirandola, Italy) is secured to a soft collar that adheres to the child's neck and is connected to a high flow NCPAP circuit (high fresh gas flow >40 L/min to avoid carbon dioxide rebreathing). To facilitate tolerance up to a maximum of 2 boluses of midazolam 0.1 mg/kg i.v. can be administered eventually followed by an i.v. continuous infusion rate according to OPS scale. Once the interface is positioned, a baseline Continuous Positive Airway Pressure (CPAP) level is set at 4 cm H2O and then raised in increments of 2 cm H2O every 20 min up to a maximum of 10 cm H2O. FiO2 is set to achieve a SpO2 ≥ 92%. If intolerance persisted despite sedative administration, the alternate interface can be used before considering tracheal intubation. All patients are kept in semirecumbent position.
16219507|NCT01242150|Device|NCPAP by facial mask|The size of NCPAP full face or nasal masks are chosen to be more comfortable for the infants (Respironics, Murrysville). The masks are secured by head straps while avoiding a tight fit and air leaks. A protective hydrocolloid sheet was applied over the nasal bridge (DuoDERM, ConvaTec, Deeside, UK). After a short adaptation period, it is firmly applied on the face by a pediatric head cap (Respironics, Murrysville ) to minimize air leaks. The mask is then connected to the same circuit previously described for helmet NCPAP.
16219508|NCT01242124|Procedure|side-to-side stapled esophagogastric anastomosis|20 patients of distal esophageal cancer receive side-to-side stapled esophagogastric anastomosis in Ivor-Lewis oesophagectomy
16219509|NCT01242124|Procedure|circular-stapled esophagogastric anastomosis|20 patients of distal esophageal cancer receive circular-stapled esophagogastric anastomosis in Ivor-Lewis oesophagectomy
16219510|NCT01242111|Drug|BMN 110|Patients will receive an intravenous infusion of BMN110 at 2.0mg/kg/week, over a period of approximately 4 hours per infusion, for up to 240 weeks.
16219511|NCT01242098|Drug|Fixed dose combination salmeterol / fluticasone|Branded fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist therapy
16219512|NCT01242098|Drug|Fixed-dose combination beclometasone dipropionate / formoterol|Branded fixed-dose combination inhaled corticosteroid / long-acting beta2-agonist therapy
16219513|NCT01242085|Procedure|trumatch group|these patient will have CT based customized knee instruments used for surgery
16219514|NCT01242085|Procedure|control group|these patients will have standard instrumentation used for for knee replacement
16219515|NCT01242072|Drug|palifosfamide-tris|Intravenous on days 1, 2 and 3 of each 21-day cycle for up to 4 cycles
16219516|NCT01242059|Dietary Supplement|yellow pea protein|Served in a tomato soup
16219517|NCT01242059|Other|yellow pea fiber|Served in a tomato soup
16219518|NCT01242059|Dietary Supplement|Control|Served in a tomato soup
16219519|NCT01242046|Dietary Supplement|Caffeine|400 mg of caffeine in tablet form
16219520|NCT01242046|Dietary Supplement|Placebo|Inert tablet
16219521|NCT01242033|Dietary Supplement|red raspberries|single serving of one, two or four cups red raspberries
16219522|NCT01242033|Dietary Supplement|bread controls|two slices white bread alone or with 200 mg vitamin C supplement
16219523|NCT01242020|Drug|Perflutren Lipid Microsphere Injectable Suspension|1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used
16219524|NCT01242007|Other|Supine spirometry|In addition to the current upright lung function evaluation we performed a supine spirometry
16219525|NCT01241994|Other|AASD dialysis technique|
16219526|NCT01241968|Device|Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)|Energy Density - 0.09 mJ/mm2
16219527|NCT01241968|Device|Placebo|Placebo
16219528|NCT01241955|Behavioral|video decision aid|video of CPR
16219529|NCT01241942|Device|Steen Solution™|This solution is a buffered dextran and albumin-containing extracellular perfusate with an optimal colloid osmotic pressure developed specifically for extra-corporeal perfusion of lungs. After EVLP, lungs will be cooled in the circuit to room temperature, then flushed with cold Perfadex™ and taken to UNC Hospitals (UNCH) where they will have an ex-vivo CT scan. Lungs determined suitable will be offered to consented patients at UNCH based on Lung Allocation Score. Lungs not considered for transplantation may be subjected to different experiments but are not to be a part of this research study. In summary, lungs with good and stable function during EVLP with Steen Solution™ will be transplanted into recipients as per current clinical practice.
16219530|NCT01241942|Other|Conventional Lung Transplant|No experimental procedures will be carried out. Lungs from conventional brain-dead organ donors will be used for transplant.
16219531|NCT01241929|Behavioral|video decision aid|video of CPR
16219532|NCT01241916|Device|Static-Progressive Splint|Static progressive splinting is a well-established adjunct for restoring elbow motion. Such splints apply a static stress relaxation force to the elbow tissues, which is sequentially increased, as motion is achieved.
16219533|NCT01241916|Device|Dynamic Splint|Dynamic splints are a popular alternative, and apply a constant prolonged force to the tissues as additional motion is achieved.
16219570|NCT01241656|Behavioral|DESI for home viewing|Decision support intervention is a 31 minute DVD mailed to the patients in all of the experimental groups. The program explains the function and location of the prostate and the nature of prostate cancer, including its associated mortality. Next, the program describes the different tests that are used to detect prostate cancer including the digital rectal exam, prostate specific antigen (PSA) test and prostate biopsy.
16219608|NCT01241409|Drug|Rabeprazole sodium: Treatment A|One single oral dose of 10 mg (1 x 10-mg capsule) rabeprazole to be-marketed sprinkle capsule granule formulation administered in fasted state. After the capsules are opened, the granules will be sprinkled on applesauce (1 tablespoon).
16219534|NCT01241903|Drug|rosuvastatin|Patients (n = 54) presenting acute coronary syndrome/non-ST elevation myocardial infarction who present within 8 hours of symptom-onset will be randomized to two groups to receive rosuvastatin (40 mg oral dose) or placebo at the time of presentation, in addition to standard of care (aspirin, clopidogrel, low molecular weight heparin). Blood will be collected at baseline (time of enrollment, immediately prior to drug or placebo), at 6 - 8 hours, at 18 - 24 hours, and at 30 days for analysis of platelet - leukocyte co-aggregate formation, biomarkers of platelet - leukocyte interactions, and biomarkers of myocardial necrosis. Additional samples may be collected just after revascularization, in patients undergoing PCI. The group of patients treated with rosuvastatin will be maintained on rosuvastatin 20 mg daily and the group randomized to placebo will be given rosuvastatin (20 mg oral once daily) within 48 hoursof enrollment and after planned PCI, but before hospital discharge.
16219535|NCT01241903|Drug|placebo|frequency and duration
16219536|NCT01241877|Dietary Supplement|astaxanthin|astaxanthin
16219537|NCT01241877|Dietary Supplement|placebo|placebo
16219538|NCT01241864|Biological|Allogenic islet cells (human, U. Chicago)|Human allogenic islet cells. Immunosuppression varies but may include prograf, cellcept, sirolimus, prednisone. Dosage will vary per patient based on weight. Patients will receive immunosuppression medications while islet cells are functioning.
16219539|NCT01241864|Procedure|Intraportal infusion of islet cells|Intraportal infusion of islet cell through the portal vein in the liver.
16219540|NCT01241851|Behavioral|Aerobic exercise|
16219541|NCT01241851|Behavioral|Resistance exercise|
16219542|NCT01241838|Device|Pacemaker|Routine postoperative temporary pacemaker Rate change of 65-80-95-110-125 beats/second in random order at day 3-4 after operation
16219543|NCT01241825|Other|Trident sugarless chewing gum.|Patients will be randomly divided into 2 groups, one subject group (these chew gum) and one control group (these do not chew gum). The subjects will have to chew Trident sugarless chewing gum for 20-30 minutes every 2 hours, all together 4 times at t=0 h, t=2, t=4 and t=6 h.
16219544|NCT01241825|Other|One control group (these do not chew gum).|The control group will not chew chewing gum while undergoing capsule endoscopy
16219545|NCT01241812|Behavioral|Lower limb muscle strengthening|Participants in the exercise group will receive a lower limb strengthening program consisting of 6 exercises targeting the quadriceps, hamstrings, and hip abductor groups. They will perform these exercises at home 4 times per week (3 sets of 10 repetitions per exercise). Over the course of the intervention, each participant will consult with the physiotherapist a total of 5 times (once per week in weeks: 1,2,3,5, and 8) to ensure proper performance of exercises and safe progression of resistance.
16219546|NCT01241799|Procedure|Endoscopic ultrasound guided fine needle aspiration biopsy|22 gauge fine needle aspiration biopsy of the pancreatic mass with the stylet in. Vacuum suction applied. 12 intra mass needle passes done. A new 22 gauge FNA biopsy needle with the style out is then used to biopsy the pancreatic mass. Vacuum suction applied. 12 intra mass needle masses done.
16219547|NCT01241799|Procedure|Stylet out FNA first, Stylet in FNA second|22 gauge FNA biopsy of pancreatic mass with the stylet out. Vacuum suction applied. 12 intra mass needle passes done. A new 22 gauge FNA biopsy needle with the stylet in is used to biopsy the pancreatic mass. Vacuum suction applied. 12 intra mass needle passes done.
16219548|NCT01241786|Drug|Revlimid|Lenalidomide PO daily Day 1-21. For patients with baseline calculated creatinine clearance ≥ 30 ml/min and < 60 ml/min the starting dose is 5 mg every other day (odd numbered days during Days 1-21). For patients with baseline calculated creatinine clearance ≥ 60 ml/min the starting dose is 5 mg daily on Days 1-21).
16219549|NCT01241786|Drug|Azacitidine|Azacitidine 75 mg/m2 IV or SC D 1-5
16219550|NCT01241773|Drug|raltegravir|One 400 mg tablet twice daily for 7 days
16219551|NCT01241773|Drug|TMC435 + raltegravir|Two 75 mg TMC435 capsules once daily and one 400 mg raltegravir tablet for 7 days
16219552|NCT01241773|Drug|TMC435|Two 75 mg capsules once daily for 7 days
16219553|NCT01241773|Drug|TMC435 + efavirenz|Two 75 mg TMC435 capsules + one 600 mg TMC278 tablet, once daily for 14 days
16219554|NCT01241773|Drug|TMC435|Two 75 mg capsules once daily for 14 days
16219555|NCT01241773|Drug|efavirenz|One 600 mg tablet once daily for 14 days
16219556|NCT01241760|Drug|Ribavirin|Ribavirin (RBV) 1000-1200 milligram (mg) per day (weight dependent) twice daily regimen oral tablets for 24 or 48 weeks depending on the patient's treatment response at week 4
16219557|NCT01241760|Drug|Telaprevir|1125 mg (3 oral tablets) twice a day (every 10-14 hours) for 12 weeks
16219558|NCT01241760|Drug|Pegylated interferon alfa-2a|180 microgram (µg) per week, subcutaneous injection, for 24 or 48 weeks Pegylated interferon alfa-2a 180 microgram (µg) per week subcutaneous injection for 24 or 48 weeks depending on the patient's treatment response at week 4
16219559|NCT01241760|Drug|Telaprevir|750 mg (2 oral tablets) every 8 hours for 12 weeks
16219560|NCT01241747|Behavioral|Walking Exercise|3 times per week for 3 months
16219561|NCT01241747|Behavioral|Control|Resistance training 3 times per week for 3 months
16219562|NCT01241734|Drug|Revlimid|"Stage I:
~Cohort 1: RICE + Lenalidomide 10mg days 1-7 Cohort 2: RICE + Lenalidomide 15mg days 1-7 Cohort 3: RICE + Lenalidomide 20mg days 1-7 Cohort 4: RICE + Lenalidomide 25mg days 1-7
~Stage III:
~Lenalidomide 25mg days 1-21 every 28 days"
16219563|NCT01241721|Device|Positron Emission Mammography (PEM)|Phase 1 of the study will involve imaging the breast with cancer up to 3 times over 2 hours using one half (1/2) of the standard dose of the radioactive tracer, F18FDG, for PEM imaging. If this reduced dose is equivalent to the standard dose then one quarter (1/4) dose will be tested to find the lowest effective radiation dose of tracer to see breast cancer. Phase 2 of the study will involve imaging of both breasts several times over a shorter duration using the lowest effective dose of tracer identified in the first part of the study. This will allow us to examine the reliability of PEM to identify a second unsuspected abnormality in either breast. Patients will be offered biopsy by ultrasound, MRI or PEM as clinically appropriate of lesions suspected of being cancer prior to final surgical planning.
16219564|NCT01241708|Drug|Bortezomib|Bortezomib 1.6mg/m2 on day -4 and day -1
16219565|NCT01241695|Dietary Supplement|Oral nutritional supplement, food for special medical purposes|2 servings of 200 ml per day, treatment period: 12 weeks
16219566|NCT01241695|Dietary Supplement|Oral nutritional supplement, food for special medical purposes|2 servings of 200 ml per day, treatment period: 12 weeks
16219567|NCT01241682|Biological|DC + CTX|3x 50x10e6 DC + cyclophosphamide
16219571|NCT01241656|Behavioral|DESI for viewing at Shared Medical Appointment|Shared medical appointment (SMA) sessions will be led by a mid-level provider. The sessions will begin with an introduction about the importance of making an informed decision about prostate cancer screening. The PSA decision support intervention will be shown and then, after the program, participants will be invited to ask questions or share their thoughts and feelings. At the end of the session, information on how to obtain a PSA screening test will be provided to participants. Men who decide in favor of a PSA test immediately following a SMA will be given a lab order which they can use to have the test performed.
16219572|NCT01241656|Behavioral|Option of SMA and DESI or DESI only|Shared medical appointment (SMA) sessions will be led by a mid-level provider. The sessions will begin with an introduction about the importance of making an informed decision about prostate cancer screening. The PSA decision support intervention will be shown and then, after the program, participants will be invited to ask questions or share their thoughts and feelings. At the end of the session, information on how to obtain a PSA screening test will be provided to participants. Men who decide in favor of a PSA test immediately following a SMA will be given a lab order which they can use to have the test performed.
16219573|NCT01241643|Drug|CYT107|repeated cycles of 3 injections of CYT107 at 20 µg/kg/week over 2 weeks, for a maximum of 4 cycles within 21 months and a maximum of 3 cycles within 12 months
16219574|NCT01241630|Procedure|Somatosensory reflex arch (Xiao Procedure)|Cross over surgery. Proximal part of L5 Ventral root is anastomosed to distal part of ventral root of S2 or S3 producing a somato-sensory reflex arch
16219575|NCT01241617|Device|Duet TRS|Endo GIA stapler with integrated Duet TRS
16219576|NCT01241617|Device|Endo GIA|Endo GIA stapler with Single Use Loading Units
16219577|NCT01241604|Device|BiPAP S/T|Mechanical Non-invasive Ventilation
16219578|NCT01241604|Device|BiPAP Auto SV3|Auto Servo Ventilation Device
16219579|NCT01241591|Drug|CP 690,550 5 mg|CP-690,550 5 mg orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks
16219580|NCT01241591|Drug|CP 690,550 10 mg|CP-690,550 10 mg orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks
16219581|NCT01241591|Biological|Etanercept 50 mg|Placebo orally dosed twice daily and etanercept 50 mg subcutaneously dosed twice weekly for 12 weeks
16219582|NCT01241591|Other|Placebo|Placebo orally dosed twice daily and placebo subcutaneously dosed twice weekly for 12 weeks.
16219583|NCT01241578|Behavioral|Lifestyle Counseling|Participants receive instructions for making healthy changes to their diet and physical activity habits.
16219584|NCT01241565|Device|ENDO GIA™ Stapler with TRI-STAPLE™ Technology|All patients will have surgery with ENDO GIA™ Stapler with TRI-STAPLE™ Technology
16219585|NCT01241552|Biological|MK-3415|A single IV infusion of MK-3415 (10 mg/kg of monoclonal antibody to Clostridium difficile Toxin A)
16219586|NCT01241552|Biological|MK-6072|A single infusion of MK-6072 (10 mg/kg of monoclonal antibody to Clostridium difficile Toxin B)
16219587|NCT01241552|Biological|MK-3415A|A single IV infusion of MK-3415A (10 mg/kg of monoclonal antibody to Clostridium difficile Toxin A and 10mg/kg of monoclonal antibody to Clostridium difficile Toxin B)
16219588|NCT01241552|Biological|Placebo|A single IV infusion of normal saline (0.9% sodium chloride)
16219589|NCT01241552|Drug|SOC|Standard of care (SOC) for CDI will be prescribed for 10 to 14 days and can begin on the day of study drug infusion; but the first dose must have been administered prior to or within a few hours following study drug infusion. SOC is defined as the receipt of oral metranidazole, oral vancomycin, IV metronidazole concurrent with oral vancomycin, oral fidaxomicin, or oral fidaxomicin concurrent with IV metronidazole.
16219590|NCT01241539|Drug|Dabigatran etexilate|150 mg capsule
16219591|NCT01241539|Drug|Dabigatran etexilate|75 mg capsule
16219592|NCT01241539|Drug|Dabigatran etexilate|110 mg capsule
16219593|NCT01241526|Other|Disease Management|"Individual, group and phone education sessions
~Telephone supporter follow-up
~LTOT monitoring"
16219594|NCT01241526|Other|Usual site management|"Usual education as per site protocol
~Usual follow-up as per site protocol
~LTOT monitoring"
16219595|NCT01241513|Drug|NAC|NAC provided to determine if beneficial at altitude
16219596|NCT01241513|Drug|Placebo|Placebo
16219597|NCT01241500|Drug|ON 01910.Na|The dose of ON 01910.Na will be 1800 mg/24 hr as a continuous intravenous infusion for 72 hours every other week for the first 16 weeks then every 4 weeks afterwards. Infusion bags must be changed every 24 hours and a new infusion bag must be used for each of the subsequent 24 hours until completion of the total 72-hour infusion time.
16219598|NCT01241487|Drug|valsartan/amlodipine|160/10 mg
16219599|NCT01241474|Dietary Supplement|EPAX 6000 (marine omega 3 EPA/DHA fatty acid concentrates|6 x 1g capsules per day of marine oil (contains 3g/d docosahexaenoic acid plus eicosapentaenoic acid) for a 9 month period
16219600|NCT01241474|Dietary Supplement|Maize (corn) oil|6 x 1g capsules per day for 9 months
16219601|NCT01241461|Drug|LY2584702|"Dose escalation starting at 50 milligram (mg). On Day 1, subjects will receive a single oral dose. After a two-day observation period, subjects will receive oral doses twice daily for a 28-day cycle.
~Patients may continue 28-day cycles of twice daily dosing until discontinuation criteria are met."
16219602|NCT01241448|Drug|LY2409021|Administered Orally
16219603|NCT01241448|Drug|Placebo|Administered Orally
16219604|NCT01241435|Drug|LY2216684|Administered orally
16219605|NCT01241422|Drug|JNJ 40929837|On Day 1: participants will receive 2 tablets of 50 mg JNJ 40929837 in the morning and 1 placebo capsule in the evening; from Days 2 to 6: they will receive 1 tablet of 50 mg JNJ 40929837 in the morning and 1 JNJ 40929837 50 mg tablet + 1 placebo capsule in the evening; and on Day 7: 1 tablet of 50 mg JNJ 40929837 in the morning.
16219606|NCT01241422|Drug|Placebo|On Day 1: participants will receive 2 placebo tablets in the morning and 1 placebo capsule in the evening; from Days 2 to 6: they will receive 1 placebo tablet in the morning and 1 placebo tablet + 1 placebo capsule in the evening; and on Day 7: 1 placebo tablet in the morning.
16219607|NCT01241422|Drug|Montelukast|On Day 1: participants will receive 2 placebo tablets in the morning and 1 montelukast capsule in the evening; from Days 2 to 6: they will receive 1 placebo tablet in the morning and 1 montelukast capsule + 1 placebo tablet in the evening; and on Day 7: 1 placebo tablet in the morning.
16219648|NCT01241084|Dietary Supplement|Antileukotrienes + Placebo|Montelukast (5mg/die) + 5 drops of placebo daily for 2 months
16219609|NCT01241409|Drug|Rabeprazole sodium: Treatment B|One single oral dose of 10 mg (2 x 5-mg capsules) rabeprazole Phase 3 sprinkle capsule granule formulation administered in fasted state. After the capsules are opened, the granules will be sprinkled on applesauce (1 tablespoon).
16219610|NCT01241409|Drug|Rabeprazole sodium: Treatment C|One single oral dose of 10 mg (1 x 10-mg capsule) rabeprazole to be-marketed sprinkle capsule granule formulation administered after consumption of a standardized high-fat high-caloric breakfast. After the capsules are opened, the granules will be sprinkled on applesauce (1 tablespoon).
16219611|NCT01241396|Other|Any MMY treatment|Any line of treatment for MMY
16219612|NCT01241383|Drug|Bosentan|Bosentan 62.5mg bid x 4 weeks; up-titrated to 125mg bid x 20 weeks
16219613|NCT01241357|Device|Hepatic biomagnetic susceptibility measurement|Subjects will first have an ultrasound study to determine the location of the liver and measure the distance from skin surface to the liver. Subjects will then be examined with the high Tc susceptometer to determine the amount of iron in the liver. The entire procedure will usually take one-half hour or less.
16219614|NCT01241344|Drug|Brincidofovir|"Adult subjects: 200mg BCV administered as 50mg tablets taken orally either once weekly (QW; 4 tablets) or twice weekly (BIW; 2 tablets).
~Pediatric subjects: 4mg/kg BCV (not to exceed a total single dose of 200mg) administered using a 10 mg/mL liquid formulation taken orally either QW (as 4 mg/kg) or BIW (as 2 mg/kg)."
16219615|NCT01241344|Other|Placebo|"Adult subjects: Matching placebo tablets taken orally either once weekly (QW; 4 tablets) or twice weekly (BIW; 2 tablets).
~• Pediatric subjects: Matching liquid placebo taken orally either QW (as 4 mg/kg) or BIW (as 2 mg/kg)."
16219616|NCT01241331|Drug|BLI1100|BLI110 topical cream
16219617|NCT01241331|Drug|Vehicle cream|Vehicle topical cream
16219618|NCT01241318|Drug|Chlorhexidine gluconate (4%)|Chlorhexidine is a topical antiseptic that has long been tested for safety and widely used in developed country hospitals, pre-surgical antiseptic technique, wound cleaning and disinfection. Mothers will be instructed to apply 10 ml of 4% chlorhexidine once a day following the infants bath every day from birth until three days after the cord completely separates from the infant's body.
16219619|NCT01241318|Procedure|Dry cord care|Mothers will be instructed to keep their infants' umbilical cord stumps clean and dry and to not apply any foreign substances to the cord stump.
16219620|NCT01241292|Biological|BMS-901608 (Elotuzumab) 10 mg|Injection, Intravenous, 10 mg/kg, Weekly at cycle 1 and 2, bi-weekly at cycle 3 and thereafter, Until disease progression or unacceptable toxicity became apparent
16219621|NCT01241292|Biological|BMS-901608 (Elotuzumab) 20 mg|Injection, Intravenous, 20 mg/kg, Weekly at cycle 1 and 2, bi-weekly at cycle 3 and thereafter, Until disease progression or unacceptable toxicity became apparent
16219622|NCT01241279|Device|Crystalens AO|Participants will undergo small incision cataract surgery (phacoemulsification). At the time of surgery, eligible participants will be implanted bilaterally with the Crystalens AO intraocular lens.
16219623|NCT01241279|Device|SoftPort LI61AO|Participants will undergo small incision cataract surgery (phacoemulsification). At the time of surgery, eligible participants will be implanted bilaterally with the SoftPort LI61AO intraocular lens.
16219624|NCT01241253|Other|Whole cooked beans with rice meals|Three types of bean-and-rice meals all equal to 50 grams available CHO. Control treatment was 50 grams available CHO in the form of white rice alone.
16219625|NCT01241240|Drug|bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy)|One drop of Triple Combination Therapy administered to each eye, twice daily for 12 weeks.
16219626|NCT01241240|Drug|Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution|One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for 12 weeks.
16219627|NCT01241214|Drug|ACT-129968|ACT-129968 (Dose 1, Dose 2, or Dose 3) or matching placebo administered orally twice daily
16219628|NCT01241214|Drug|ACT-129968|ACT-129968 (Dose 4) & matching placebo administered orally once daily
16219629|NCT01241214|Drug|Cetirizine|Ceterizine administered once daily
16219630|NCT01241214|Drug|Placebo|Matching placebo administered twice daily.
16219631|NCT01241201|Dietary Supplement|Priobiotic supplement VSL#3|four weeks, twice daily two sachets of VSL#3, a priobitics mixture
16219632|NCT01241188|Biological|C-Tb|The C-Tb agent is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearms according to a double blind randomisation scheme
16219633|NCT01241188|Biological|2 TU Tuberculin PPD RT 23 SSI|The 2 TU Tuberculin PPD RT 23 SSI agent is administered by the Mantoux injection technique to each volunteer in the RIGHT or LEFT forearms according to a double blind randomisation scheme
16219634|NCT01241175|Drug|Magnesium Sulfate|
16219635|NCT01241175|Drug|normal saline|
16219636|NCT01241162|Biological|Autologous dendritic cell vaccine with adjuvant|"Week 1:
~Decitabine (DAC): 10 mg/m2/day IV (Mon-Fri)
~Weeks 2 and 3:
~Vaccine: 3-5 E6 peptide pulsed DC (Mon)
~Hiltonol applied topically to vaccine site before and after vaccination"
16219637|NCT01241149|Procedure|anti-reflux surgery|Anti-reflux surgery (Laparoscopic Nissen Fundoplication)
16219638|NCT01241136|Procedure|open wide-excision pilonidal cystectomy|traditional open wide-excisional pilonidal cystectomy
16219639|NCT01241136|Procedure|minimal invasive pilonidal cystotomy|unroofing the cyst cavity and curettage the cyst
16219640|NCT01241123|Procedure|Ambulation regimen|Assistance and encouragement for at least ambulation 3 times a day
16219641|NCT01241123|Drug|Sitz-Markers|radiopaque markers to subjectively follow the return of bowel function
16219642|NCT01241123|Radiation|Daily abdominal x-rays|daily abdominal x-rays for 7 days - to follow the radiopaque markers
16219643|NCT01241123|Device|pedometers|to record the amount of ambulation
16219644|NCT01241110|Drug|Ofloxacin group A, Azitromycin group B|Group A (treated by Ofloxacin 400 mg. + Metronidazole 500mg) and Group B (a single dose of oral Azitromicine 1gr + Metronidazole 500mg) for 10 days, were compared in terms of side effects and efficacy.
16219645|NCT01241110|Drug|azitromycin|azitromicin vs ofluxacin
16219646|NCT01241097|Drug|simvastatin, combined with simvastatin ezetimibe, placebo|simvastatin 80 mg per days or simvastatin 10 mg and ezetimibe 10 mg, over a period of eight weeks, treatment consisted of tablets identical, or placebo
16219647|NCT01241084|Dietary Supplement|Antileukotrienes + Lactobacillus reuteri|Montelukast (5mg/die) + 1000000000 CFU per day (5 drops) for 2 months
16219650|NCT01241071|Other|Placebo|A manual sham intervention will be applied to different muscles implicated in low back pain
16219651|NCT01241032|Drug|Udenafil|200mg Single Oral Dose of
16219652|NCT01241032|Dietary Supplement|Alcohol|Alcohol 39g / 240ml
16219653|NCT01241019|Drug|Topiramate in newborns with hypoxic ischemic encephalopathy treated with therapeutic hypothermia|TPM 10 mg/kg once a day will be administered with an orogastric tube as enteric-coated granules mixed with water on arrival in the NICU, when the cooling will be begun (T0), once a day for the first 3 days of life, for a total of 3 doses per patient.
16219654|NCT01241006|Drug|Dexamethasone|Dexamethasone 12mg PO single dose x 1 Placebo 1 capsule PO for 4 days
16219655|NCT01241006|Drug|Prednisone|Prednisone 60mg PO q day for 5 days
16219656|NCT01240993|Behavioral|Mothers and Toddlers Program|This intervention is a short-term attachment-based parenting therapy for substance using mothers of young children that emphasizes the development of the capacity for mentalizing.
16219657|NCT01240993|Behavioral|Parent Education|PE was developed to represent parent education and support that is typically available to mothers with substance use problems who are at high risk for neglecting their young children. Mothers enrolled in PEP will meet weekly for one hour with a PE counselor who will provide assistance in solving problems related to family basic needs and a choice of pamphlets on age-related parenting topics.
16219658|NCT01240980|Drug|BMS-903452|Solution, Oral, 0.1 mg, once daily, 1 day
16219659|NCT01240980|Drug|BMS-903452|Solution, Oral, 0.6 mg, once daily, 1 day
16219660|NCT01240980|Drug|BMS-903452|Suspension, Oral, 3.0 mg, once daily, 1 day
16219661|NCT01240980|Drug|BMS-903452|Suspension, Oral, 10 mg, once daily, 1 day
16219662|NCT01240980|Drug|BMS-903452|Suspension, Oral, 30 mg, once daily, 1 day
16219663|NCT01240980|Drug|BMS-903452|Suspension, Oral, 60 mg, once daily, 1 day
16219664|NCT01240980|Drug|BMS-903452|Suspension, Oral, 120 mg, once daily, 1 day
16219665|NCT01240980|Drug|Placebo|Solution, Oral, 0 mg, once daily, 1 day
16219666|NCT01240980|Drug|Placebo|Suspension, Oral, 0 mg, once daily, 1 day
16219667|NCT01240980|Drug|BMS-903452|Suspension using crystalline form, Oral, 10 mg, once daily, 1 day
16219668|NCT01240980|Drug|BMS-903452|Suspension using crystalline form, Oral, 60 mg, once daily, 1 day
16219669|NCT01240980|Drug|Placebo|Suspension using crystalline form, Oral, 0 mg, once daily, 1 day
16219670|NCT01240980|Drug|BMS-903452|Solution, Oral, 0.6 mg, once daily, 1 day
16219671|NCT01240980|Drug|BMS-903452|Suspension, Oral, 10 mg, once daily, 1 day
16219672|NCT01240980|Drug|BMS-903452|Suspension, Oral, 120 mg, once daily, 1 day
16219673|NCT01240967|Drug|TC-5214|Oral tablets, single dose
16219674|NCT01240954|Drug|OSIRIS|OSIRIS current practice
16219675|NCT01240954|Drug|OSIRIS other concentration 1|OSIRIS new concentration 1
16219676|NCT01240954|Drug|OSIRIS other concentration 2|OSIRIS new concentration 2
16219677|NCT01240941|Drug|MK-2206|dose to be determined on the Phase 1b trial (listed under a separate NCT number)
16219678|NCT01240941|Drug|Exemestane|25 mg orally daily
16219679|NCT01240941|Drug|Goserelin|3.6 mg orally monthly
16219680|NCT01240928|Drug|MSK-2206|Level 1: MK-2206 135mg weekly
16219681|NCT01240928|Drug|Exemestane|Level 1: Exemestane - 25mg daily
16219682|NCT01240928|Drug|Goserelin|Level 1: Goserelin- 3.6mg monthly for pre-menopausal subjects only
16219683|NCT01240915|Drug|placebo|once every 7 days for 1- 3 doses
16219684|NCT01240915|Drug|MultiStem low dose|1-3 doses
16219685|NCT01240915|Drug|placebo|Single dose at week 8
16219686|NCT01240915|Drug|MultiStem low dose|Single dose at week 8
16219687|NCT01240915|Drug|placebo|Single dose Day 1
16219688|NCT01240915|Drug|MultiStem high dose|Single dose Day 1
16219689|NCT01240915|Drug|placebo|Single dose at week 8
16219690|NCT01240915|Drug|MultiStem high dose|Single dose at week 8
16219691|NCT01240915|Drug|placebo|Single dose Day 1
16219692|NCT01240915|Drug|MultiStem high dose|Single dose Day 1
16219693|NCT01240915|Drug|placebo|Single dose at week 8
16219694|NCT01240915|Drug|MultiStem high dose|Single dose at week 8
16219695|NCT01240902|Device|Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)|Medtronic CoreValve® System Transcatheter Aortic Valve Implantation (TAVI)
16219696|NCT01240902|Device|Surgical Aortic Valve Replacement (SAVR)|Surgical Aortic Valve Replacement (SAVR)
16219697|NCT01240889|Drug|Fluticasone|nasal spray
16219698|NCT01240889|Drug|Fluticason|2 sprays per day in each nostril
16219699|NCT01240876|Drug|CEP-37247|0.5-, 1-, 3-, 6-, and 12-mg doses of CEP-37247 will be administered by the transforaminal epidural route.
16219700|NCT01240876|Drug|Placebo|Matching placebo vials will be filled with the buffered solution for CEP-37247.
16219701|NCT01240863|Drug|Hydrocodone ER|"During the open-label, titration period, all participants were administered hydrocodone ER tablets at dosages of 15, 30, 45, 60, or 90 mg every 12 hours to identify a dosage deemed successful for managing their pain.
~Hydrocodone ER was taken by participants randomized to the hydrocodone ER treatment arm during the double-blind treatment period at the dose level identified during the titration period.
~Participants were instructed to take tablets with a glass of water on an empty stomach at least 1 hour before or 2 hours after eating."
16219702|NCT01240863|Drug|Placebo|"Placebo matching the active drug dose identified during the titration period was taken by participants randomized to the placebo treatment arm during the double-blind treatment period.
~Participants were instructed to take intervention with a glass of water on an empty stomach at least 1 hour before or 2 hours after eating."
16219703|NCT01240850|Drug|Methotrexate+Prednisone|Methotrexate will be added at a dose of 0.3 mg/kg/week (maximum dose, 20 mg/week, orally) to a reduced-dose prednisone regimen
16219704|NCT01240850|Drug|Prednisone|
16219705|NCT01240837|Other|Arenga Pinnata Sugar|50 g palm sugar given orally 1 time in 250 ml of water. Blood glucose measurements will then be taken at time points, 0, 15, 30, 45, 60, 90 and 120 minutes.
16219706|NCT01240837|Other|Glucose|50 g glucose given orally 3 time in 250 ml of water. Blood glucose measurements will then be taken at time points, 0, 15, 30, 45, 60, 90 and 120 minutes.
16220068|NCT01237951|Drug|Dexamethasone|8 mg IV twice a day by vein over 15 minutes Days -9 through -2 as an outpatient or inpatient.
16219707|NCT01240837|Other|Sucrose|50 g sucrose given orally 1 time in 250 ml of water. Blood glucose measurements will then be taken at time points, 0, 15, 30, 45, 60, 90 and 120 minutes.
16219708|NCT01240824|Drug|aminophylline|One of three escalating doses of aminophylline (3 mg/kg, 6 mg/kg and 9 mg/kg) administered intravesically
16219709|NCT01240811|Drug|IUD placement|Volunteer subjects who are not at risk of pregnancy because they are either surgically sterilized or heterosexually abstinent will be enrolled into the control group (no intervention). All other volunteers will be seeking an IUD for contraception and will be randomized to LNG-IUD (Mirena) or Copper IUD (ParaGard).
16219710|NCT01240811|Drug|Levonorgestrel IUD|
16219711|NCT01240811|Drug|Copper T380A IUD|
16219712|NCT01240785|Drug|metformin|metformin 1 g twice daily or maximum tolerated dose less than 2 g daily
16219713|NCT01240785|Drug|insulin|subcutaneous Neutral Protamine Hagedorn (NPH) insulin and/or rapid acting insulin analog adjusted according to plasma glucose values until delivery
16219714|NCT01240772|Device|doppler-guided arterial ligation with mucopexy|doppler-guided arterial ligation with mucopexy
16219715|NCT01240772|Device|stapled haemorrhoidopexy according to Longo|stapled haemorrhoidopexy according to Longo
16219716|NCT01240759|Drug|S-707106 Dose A|One S-707106 A tablet
16219717|NCT01240759|Drug|S-707106 Dose B|One S-707106 B tablet
16219718|NCT01240759|Drug|S-707106 Dose C|Four S-707106 4 X B tablets
16219719|NCT01240759|Drug|Placebo A tablet|Up to 4 Placebo A tablets
16219720|NCT01240759|Drug|Metformin|The standard of care dose of metformin for each patient
16219721|NCT01240746|Biological|Licensed 2010-2011 Trivalent Influenza Vaccine, No Preservative|0.25 mL (6 to 35 months) or 0.5 mL (3 to <9 years), Intramuscular
16219722|NCT01240746|Biological|Investigational Trivalent Influenza Vaccine with alternate B strain, No Preservative|0.25 mL (6 to 35 months) or 0.5 mL (3 to <9 years), Intramuscular
16219723|NCT01240746|Biological|Quadrivalent Influenza Vaccine, No Preservative|0.25 mL (6 to 35 months), or 0.5 mL(3 to <9 years), Intramuscular
16219724|NCT01240720|Drug|131I-F16SIP Radioimmunotherapy (RIT)|"Dosimetric evaluation with 131I-F16SIP or 124I-F16SIP will be performed to assess eligibility for Radioimmunotherapy.
~Patients eligible for Radioimmunotherapy will receive 55.5 mCi/m2 as established in the Phase I part of the study. A single dose of 5 to 10 mg of 131I-F16SIP will be administered intravenously (I.V)."
16219725|NCT01240707|Other|Fiberoptic bronchoscopy|Fiberoptic bronchoscopy performed to remove secretions and assess soot in central airways
16219726|NCT01240694|Drug|Lupuzor|200 mcg
16219727|NCT01240681|Procedure|FLT PET and BOLD MRI scan|Eligible consenting patients with LABC receiving neoadjuvant chemotherapy (NA CT) will undergo FLT PET, BOLD MRI, and clinical examination of the involved breast including ipsilateral axillary and supraclavicular nodes to assess the treatment response to chemotherapy (CT). The imaging studies will be performed at baseline and after the first cycle of NA CT.
16219728|NCT01240655|Drug|LCL161|
16219729|NCT01240655|Drug|Paclitaxel|
16219730|NCT01240642|Drug|ASA404|
16219731|NCT01240629|Other|laboratory biomarker analysis|Correlative study
16219732|NCT01240629|Other|questionnaire administration|Correlative study
16219733|NCT01240629|Drug|doxorubicin-GnRH agonist conjugate AEZS-108|Given IV
16219734|NCT01240590|Drug|Crolibulin|Phase I:Dose Level (DL) 1 - 13 mg/m(2) intravenous (IV),DL 2 - 13 mg/m(2) IV, DL 3 - 20 mg/m(2) IV. Phase II: 20 mg/m(2)
16219735|NCT01240590|Drug|Cisplatin|Phase I:Dose Level (DL) 1- 75 mg/m(2) intravenous (IV),DL 2 - 100 mg/m(2),DL 3 - 100 mg/m(2). Phase II: 100 mg/m(2)
16219736|NCT01240577|Drug|IPdR|
16219737|NCT01240551|Drug|F-18 NaF|All participants will undergo a static F-18 NaF PET/CT imaging session at baseline, at 4-8 months, and at 10-14 months following enrollment (3 sessions over 1-year). Half of the participants (15 in each group) will undergo two baseline F-18 NaF PET/CT imaging sessions (within 14-days of each other) in order to evaluate the reproducibility of F-18 NaF PET imaging for a total of 4 sessions over a 1-year period.
16219738|NCT01240538|Biological|wild-type reovirus|Given IV
16219739|NCT01240538|Drug|cyclophosphamide|Given PO
16219740|NCT01240538|Other|laboratory biomarker analysis|Correlative studies
16219741|NCT01240538|Other|pharmacological study|Correlative studies
16219742|NCT01240525|Other|CD4 DLI|Patients will receive CD4 DLI between day 70 to 115 post transplant
16219743|NCT01240525|Other|No DLI|Patients will not receive DLI as trial treatment
16219744|NCT01240512|Drug|Cholecalciferol|Vitamin D3 (cholecalciferol) 200 IU and 2000 IU drops will be supplied by D Drops. It is supplied as a liquid containing 400 drops/bottle with a potency of 200 IU/drop or 2000 IU/drop. The contents of the label will be in accordance with all applicable regulatory requirements. The droppers are gravity-metered to deliver a consistent drop size (dosage). Two drops (either 200 IU or 2000 IU) of Vitamin D (cholecalciferol) is to be taken orally once-daily.
16219745|NCT01240499|Other|Health-At-Every-Size (HAES)|"HAES group: 14 weekly sessions.
~Focus on general well-being and positive ways of having a healthy and satisfying lifestyle. Supported by lectures, guided self-reflection, group discussions, as well as practical exercises, this intervention aims at enhancing awareness and knowledge about biological, psychological, and sociocultural aspects of body weight.
~SS group: 14 weekly sessions.
~The objective is to reproduce a structural social support provided by the group itself. Each participant offers their support to each other. Each theme discussed in the HAES group is repeated in the SS group but the health professionals in charge of the group (dietitian & psychologist) are not counselors (as in HAES group) but only facilitators.
~Outcome measures: For all women under study."
16219746|NCT01240473|Drug|Randomized trial for treatment of kala azar in Bangladesh|dose of SAG 20 mg/kg body weight, with a maximum dose of 850 mg/day, for 28 days
16219747|NCT01240460|Drug|XL765 (SAR245409)|Supplied as 10-mg and/or 50-mg capsules
16219748|NCT01240460|Drug|XL147 (SAR245408)|Supplied as 100-mg, 150-mg and/or 200-mg tablets
16219749|NCT01240447|Biological|racotumomab|Patients will receive best support treatment and vaccination with racotumomab. The vaccination schedule is as follows: 5 doses (1mg/mL each), subcutaneously, every 2 weeks (induction period) followed by monthly vaccinations until any criteria for discontinuation are met. If disease progression occurs and a second line therapy is indicated, the patient will only be able to continue in the study if the drug indicated is docetaxel. Vaccination will not be interrupted during docetaxel administration unless criteria for vaccine discontinuation are met.
16219750|NCT01240447|Other|Best support treatment|Patients will receive best support treatment as indicated by the investigator. In case a second line therapy is indicated, docetaxel is the only drug allowed to continue in the study.
16219751|NCT01240434|Procedure|Trocar site closure|The study has 2 arms: one in which all the ST orifices are closed by suturing the external fascia of the abdominal wall with a number 1 monofilament absorbable suture (Polydioxanone) (Group A), and another in which all the orifices of the ST are left open, closing only the skin (Group B).
16219752|NCT01240421|Drug|Eribulin Mesylate|At a dose of 1.4 mg/m2 as a 2 to 5 minute intravenous bolus on Days 1 and 8 of a 21-day cycle.
16219753|NCT01240408|Drug|HOPE|10 mg lenvatinib (1x10 mg lenvatinib capsule) with food
16219754|NCT01240408|Drug|HOPE|10 mg lenvatinib (1x10 mg lenvatinib capsule) without food
16219755|NCT01240395|Behavioral|Mindfulness-based Cognitive Therapy (MBCT)|"MBCT is partly based on the mindfulness-based stress reduction program (MBSR), developed by Jon Kabat-Zinn and colleagues, and partly on cognitive therapy for depression, the latter influence particularly expressed through the aspect of decentering, meaning not accepting the content of thoughts as facts and not identifying with the thought. The MBCT programme in this study includes 2½ hours of training once a week for 9 weeks. In addition, participants are encouraged to practice at home for up to 45 min per day, 6 days a week during the entire course."
16219756|NCT01240382|Drug|3% DE-089 ophthalmic solution|
16219757|NCT01240382|Drug|0.1% sodium hyaluronate ophthalmic solution|
16219758|NCT01240356|Device|2-MHz transcranial Doppler ultrasound|2-hours of hands-free ultrasound will be insonated continuously. A brain MRI with gadolinium will be performed before and after the ultrasound.
16219759|NCT01240356|Device|2-MHz transcranial Doppler ultrasound insonation|2-hours of hands-free ultrasound delivered to in the intracranial vessels.
16219760|NCT01240330|Device|Pneumatic Compression therapy|Subject comparison analysis of femoral venous Peak Flow Velocity at rest and during compression therapy.
16219761|NCT01240304|Drug|Gemcitabine|The course of preoperative treatment in this study will consist of an alternating combination of 6mg/M² of Gemcitabine for 24 hours and 7.0 Gy (radiation) of radiation therapy. The subject will undergo one of these therapies alternating daily for a total of 10 days then the subject will be allowed to rest for 4 weeks before undergoing restaging and surgery. After surgery, the subject will then undergo the conventional chemotherapy regimen consisting of 6 cycles (1 cycle = 28 days) of 1000mg/M² of Gemcitabine over a 30 minute infusion rate.
16219762|NCT01240304|Radiation|Radiation therapy|The course of preoperative treatment in this study will consist of an alternating combination of 6mg/M² of Gemcitabine for 24 hours and 7.0 Gy (radiation) of radiation therapy. The subject will undergo one of these therapies alternating daily for a total of 10 days then the subject will be allowed to rest for 4 weeks before undergoing restaging and surgery. After surgery, the subject will then undergo the conventional chemotherapy regimen consisting of 6 cycles (1 cycle = 28 days) of 1000mg/M² of Gemcitabine over a 30 minute infusion rate.
16219763|NCT01240304|Procedure|pancreaticoduodenectomy|Surgery will be planned 28 days (+/- 3 days) after the last dose of chemotherapy. The liver and pancreas will be examined by palpation and inspection. In the absence of metastases, tumor mobilization and surgical resection will be performed with standard surgical technique.
16219764|NCT01240291|Dietary Supplement|Dipeptiven|Intravenous alanyl-glutamine (0.5 g/kg body weight; i.e. 0.35 g L-glutamine / kg body weight; continuous infusion (20-24 hr/day) via central venous access for a maximum duration of 3 weeks.
16219765|NCT01240291|Dietary Supplement|normal saline|0.5 g/kg bod weight /day, continuous infusion (20-24 hr/day) via central venous access for a maximum duration of 3 weeks
16219766|NCT01240265|Dietary Supplement|Vitamin D3|150,000 IU orally given once
16219767|NCT01240265|Dietary Supplement|Vitamin D3|5000 IU given orally daily for 28 days
16219768|NCT01240252|Drug|Human insulin|U100 Humulin at a rate of 80 mU/m^2 surface area per minute one time over 4 hours
16219769|NCT01240226|Drug|GDC-0941|Oral repeating dose
16219770|NCT01240226|Drug|GDC-0941|Oral repeating dose
16219771|NCT01240226|Drug|ketoconazole|Oral repeating dose
16219772|NCT01240213|Dietary Supplement|Vitamin D|2000 IU per day of Vitamin D
16219773|NCT01240213|Dietary Supplement|Placebo|1 Placebo per day
16219774|NCT01240200|Drug|Glargine|oral antidiabetic agents plus once daily insulin glargine via an insulin syringe
16219775|NCT01240200|Device|glargine via insulin pen|oral antidiabetic agents plus insulin glargine in a pre-filled pen
16219776|NCT01240187|Drug|perampanel|Single dose of 6 tablets 2 mg orally
16219777|NCT01240187|Drug|perampanel|Single dose of 1 tablet 12 mg orally
16219778|NCT01240174|Behavioral|Demonstration of near zero antibiotic prescribing for patients with acute bronchitis|A controlled, continuously-monitored, implementation of an EHR-integrated diagnosis and treatment algorithm for acute bronchitis in a large, diverse primary care practice.
16219779|NCT01240161|Drug|FLT-PET/CT: (3'deoxy-3'-[(18)F] fluorothymidine) PET/CT|Each patient will have 0-3 or more FLT-PET brain scans.
16219780|NCT01240148|Drug|AZD3161|Single dose, intradermal injection
16219781|NCT01240148|Drug|Lidocaine|Single dose, intradermal injection
16219782|NCT01240148|Drug|AZD3161 Placebo|
16219783|NCT01240135|Device|FID 114675A multi-purpose disinfecting solution (MPDS)|Daily regimen, 14 days: Thoroughly wet and rub each side of study contact lens for 10 seconds, rinse each side of the lens for 10 seconds, and soak contact lens for at least 6 hours.
16219784|NCT01240135|Device|renu fresh Multi-Purpose Solution (MPS)|Daily regimen, 14 days: Wet study contact lens with 3 drops and rub each side of the lens for 20 seconds, rinse each side of the lens for 5 seconds, and soak contact lens for at least 4 hours.
16219785|NCT01240135|Device|Galyfilcon A contact lenses (Acuvue Advance)|A fresh pair of contact lenses matching subject's pre-study lenses, including parameters, dispensed at the beginning of each period for daily wear, minimum 8 hours per day, 14 days.
16219786|NCT01240122|Device|Biotrue MPS|Multi-purpose contact lens care solution
16219787|NCT01240122|Device|Investigational MPS|Multi-purpose contact lens care solution
16219788|NCT01240109|Drug|Remifentanil|"propofol group : propofol effect site-TCI 2-4mcg/ml + remifentanil effect site-TCI 2-4ng/ml
~sevoflurane group: sevoflurane end-tidal concentration 0.5-1.0 MAC + remifentanil effect site-TCI 2-4ng/ml"
16219789|NCT01240096|Drug|Mirtazapine|Mirtazapine 15 mg daily
16219790|NCT01240083|Device|Thetaburst Stimulation|Thetaburst stimulation: continuous TBS over the right DLPFC, followed by intermitted TBS over the left DLPFC, each with 50 Hz, together 1200 stimuli (80% motorthreshold)
16219791|NCT01240083|Device|High frequency rTMS|Experimental high frequency rTMS ( Alpine Biomed Mag Pro Option) : 1000 stimuli of 1 Hz over the right DLPFC (110% motor threshold)followed by 1000 stimuli of 10 Hz over the left DLPFC (110% motorthreshold)
16219792|NCT01240083|Device|Placebo Stimulation|Sham Stimulation (Sham coil):right DLPFC continuous TBS, followed by left DLPFC intermitted TBS each with 50 Hz, together 1200 Stimuli, 80% motorthreshold
16219793|NCT01240070|Other|Intensive care|Intensive multi-factorial treat-to-target intervention program designed according to international guidelines
16219794|NCT01240057|Procedure|fetal endoluminal tracheal occlusion|percutaneous fetoscopy, positioning of endoluminal balloon at 27-30 weeks and whenever possible elective removal at 34 weeks
16219795|NCT01240057|Other|watchful waiting during pregnancy|pregnancy surveillance for fetal wellbeing, development of polyhydramnios and cervical shortening
16219796|NCT01240044|Procedure|Thoracoabdominal rebalancing|In this group the infants received four handlings thoracoabdominal rebalancing, in order: 1) 5min support thoracoabdominal, in which the therapist leaned one hand on the lower chest and upper abdomen of the newborn, with some of its fingers on the ribs, pulling them gently down and keeping them in that position during inspiration, 2) more than 5 minutes of abdominal support, carried by hand in the lower abdomen of the newborn, applying light pressure during inspiration enough to be beaten by the diaphragm of the newborn and not to increase the use of accessory muscles of inspiration, 3) 5min support ileo-costal, by a slight manual pressure of the physiotherapist on the lateral chest and abdomen of the newborn, maintained throughout inspiration and 4) finally ran up 5min ginga thoracic maneuver slight manual pressure on the lower chest of newborns, directing the costal movement during expiration, now an then the other hemithorax.
16219797|NCT01240044|Procedure|Physical Therapy|In this group the newborns were first submitted to the mechanical vibrator applied over a diaper, on the chest of newborns for 5 min, as follows: 1min 1min right hemithorax and the left hemithorax, both previously, followed 30 seconds in the lateral aspect of each hemithorax; more than 1min in each hemithorax in the posterior region. The mechanical vibrator was performed subsequent to manual chest compression, using light hand pressure on the chest of newborns, respecting the compliance of the chest. The chest compression was applied for 2min 2min in the right hemithorax and left-sided chest, above, and 1 minute on each side, another 2 minutes on the back of each hemithorax, totaling 10 minutes of compression. Next to chest compression, mechanical vibration was applied for 5 min in the same topographical sequence described.
16219798|NCT01240031|Other|Individualised nutritional therapy|"Nutritional therapy as based on previous results of the project on patient meal experiences and preferences (note citations below) and comprising of:
~Thorough sensory and nutrition assessment (questionnaire).
~Nutrition plan adjusted daily according to the assessment.
~Serving appetising, energy- and protein-dense meals, snacks and drinks."
16219799|NCT01240031|Other|Usual nutrition care|Nutritional therapy according to current practice and general nutrition advice.
16219800|NCT01240018|Dietary Supplement|Probiotic|Parallel, randomized, controlled 2 arms study.
16219801|NCT01240005|Biological|DCIK|Renal cell carcinoma patients were treated with three intravenous infusions of DC activated CIK cells at 1-day intervals. Clinical examinations of these patients were performed.
16219802|NCT01239992|Drug|Niacin/ Laropiprant|1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily
16219803|NCT01239966|Device|Combined ECCOR and RRT|Insertion of a membrane oxygenator (Hilite 2400 LT, Medos, Germany) within an hemofilter circuit (M150,PrismaFlex, Hospal); either upstream or downstream of the hemofilter.
16219804|NCT01239953|Device|Coronary angioplasty using the paclitaxel-eluting balloon|Balloon angioplasty
16219805|NCT01239953|Device|Coronary angioplasty using the everolimus-eluting stent|Stent implantation
16219806|NCT01239940|Device|Coronary angioplasty using the paclitaxel-eluting balloon|Balloon angioplasty
16219807|NCT01239940|Device|Coronary angioplasty using the Everolimus-eluting stent|Stent implantation
16219808|NCT01239927|Procedure|Primary sigmoid resection with end colostomy (Hartmann)|
16219809|NCT01239927|Procedure|Primary sigmoid resection and immediate anastomosis with diverting stoma (PRA)|
16219810|NCT01239888|Drug|Oxytocin|20 IU of intranasal oxytocin twice per day for 8 weeks, and a placebo (oral) for the 8 week trial
16219811|NCT01239888|Drug|Oxytocin and Tibolone|20 IU of intranasal oxytocin twice per day for 8 weeks, and 2.5mg oral tibolone for the 8 week trial
16219812|NCT01239888|Drug|Placebo|20 IU of intranasal placebo twice per day for 8 weeks, and a placebo (oral) for the 8 week trial
16219813|NCT01239875|Biological|dendritic cell vaccine therapy|Given intratumorally
16219814|NCT01239875|Procedure|cryotherapy|Undergo cryoablation
16219815|NCT01239875|Biological|pneumococcal polyvalent vaccine|Given intramuscularly
16219816|NCT01239875|Other|laboratory biomarker analysis|Correlative studies
16219817|NCT01239875|Other|immunoenzyme technique|Correlative studies
16219818|NCT01239875|Other|immunohistochemistry staining method|Correlative studies
16219819|NCT01239875|Biological|autologous dendritic cell-tumor fusion vaccine|Given intradermally
16219820|NCT01239862|Other|Autologous cell transplantation|Intrabronchial Instillation Of Bone Marrow Derived Mononuclear Cells
16219821|NCT01239849|Drug|Atorvastatin, 10mg, 20mg, 40mg|"If initial LDL cholesterol between 100~ 129mg/dl then starting dose of Atorvastatin is 10mg, 130~159 mg/dl is 20 mg, 160~220mg/dl is 40mg.
~After 4weeks treatment, if LDL cholesterol is below 100mg/dl then continue starting dose and if not reach below 100mg/dl then titration double dose.
~After 4 weeks treatment, recheck the LDL cholesterol"
16219822|NCT01239836|Behavioral|Constructivist interactive workshop on urinary incontinence|A one hour interactive group workshop aimed at contradicting commonly held beliefs and maladaptive practices about incontinence. The interactive continence workshop was designed to create cognitive dissonance and challenge these beliefs and practices, as well as to promote more effective therapeutic strategies for correcting urine leakage.
16219823|NCT01239836|Behavioral|Evidence-based self-management tool|Participants will receive a customized evidence-based risk factor modification self-management tool targeting up to 6 risk factors and associated therapeutic strategies. The six risk factors are pelvic floor muscle weakness, consumption of caffeinated drinks, obesity, constipation, vision loss and smoking.
16219824|NCT01239836|Behavioral|General health lecture|Participants will attend a lecture on general women's health issues that does not address urinary incontinence.
16219825|NCT01239823|Other|Whole Body Vibration Training|The subjects will participate in a 12-week exercise program with two sessions (1/2 hour) per week.
16219826|NCT01239823|Other|Exercise without vibration|Participants will complete the same exercises without vibration twice a week for 12 weeks (1/2 hour sessions).
16219827|NCT01239810|Drug|Hyaluronic Acid|Intraarticular injection 2ml Na-Hyaluronate (HA; MW 1.2 x 106; Ostenil, TRB Chemedica) weekly for five weeks
16219833|NCT01239784|Behavioral|Home-based neurodevelopmental rehabilitation programme|Participation in the study will require the parent and child to attend two assessment visits in addition to completing a series of parent and infant activities on a daily basis throughout the 10-week intervention period. The parent-led activities will include activities such as walking with the child, stacking blocks, rolling a ball to the child, hiding a toy under a blanket for the child to find, encouraging the child to kick a rattle while the child is lying on his/her back, or crawling or rolling in different directions.
16219834|NCT01239771|Drug|TC-5214|Tablet 1, 2, or 4 mg of TC-5213 will be given twice daily for 4 days and once on the 5th day.
16219835|NCT01239771|Drug|Placebo|Two subjects in each cohort will be given placebo.
16219836|NCT01239758|Biological|ACE-031 (Extension of cohort 1 from core study, A031-03)|ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 24 weeks.
16219837|NCT01239758|Biological|ACE-031 (Extension of cohort 2 from core study, A031-03)|Up to 1.0 mg/kg subcutaneously once every 2 weeks for 24 weeks.
16219838|NCT01239758|Biological|ACE-031 (Extension of cohort 3 from core study, A031-03)|Up to 2.5 mg/kg subcutaneously once every 4 weeks for 24 weeks.
16219839|NCT01239745|Drug|Aromasin|Aromasin® one 25 mg tablet to be taken once daily
16219840|NCT01239732|Drug|Paclitaxel|175 mg/m^2 on Day 1 every 3 weeks or at a dose of 80 mg/m^2 every week for a minimum of 4 cycles and not more than 8 cycles or until disease progression or unacceptable toxicity, whichever occurs first
16219841|NCT01239732|Drug|Bevacizumab|15 mg/kg intravenously on Day 1 of every cycle for up to 36 cycles of 3 weeks each or until disease progression or unacceptable toxicity, whichever occurs first
16219842|NCT01239732|Drug|Carboplatin|AUC 5-6 mg/ml/min on Day 1 every 3 weeks for a minimum of 4 cycles and not more than 8 cycles or until disease progression or unacceptable toxicity, whichever occurs first
16219843|NCT01239719|Drug|Dexamethasone + clemastine|Dexamethasone 0.5 mg clemastine fumarate: 01 tablet every 12 hours.
16219844|NCT01239719|Drug|Dexamethasone|Dexamethasone 0.5 mg: 01 tablet every 12 hours.
16219845|NCT01239706|Drug|NTx 265|10,000IU of hCG, every other day for three doses followed by 4000IU once daily for three days of erythropoietin
16219846|NCT01239693|Dietary Supplement|IFA|Women during pregnancy: 1 tablet of iron+ folate daily until delivery (60 mg iron + 400 ug folic acid) Women during lactation (from delivery to 6 months post-partum): 1 daily tablet of calcium (200 mg), akin to placebo Children from 6 to 18 months of age: None
16219847|NCT01239693|Dietary Supplement|MMN|Women during pregnancy: 1 tablet of multiple micronutrients daily until delivery Women during lactation (from delivery to 6 months post-partum): 1 daily tablet of multiple micronutrients Children from 6 to 18 months of age: None
16219848|NCT01239693|Dietary Supplement|LNS|Women during pregnancy: 1 sachet of LNS-P&L (20 g of LNS) daily until delivery Women during lactation (from delivery to 6 months post-partum): 1 daily sachet of LNS-P&L (20 g of LNS) Children from 6 to 18 months of age: 2 daily sachet of LNS-20gM (20 g of LNS)
16219849|NCT01239680|Drug|Glutamine|Intravenous 25 grams once over 6 hours
16219850|NCT01239680|Drug|Ringer's Lactate|Intravenous 1 liter once over 6 hours
16219851|NCT01239680|Drug|Placebo (for Glutamine)|Given Intravenously in 1 liter Lactated Ringer's
16219852|NCT01239667|Other|Individual oriented planning of the rehabilitation program for patients with heart failure|Individual oriented rehabilitation plan in collaboration with the patient followed by measuring health related quality of life and self care behavior
16219853|NCT01239654|Device|stent implantation|implantation of everolimus-eluting stent vs zotarolimus-eluting stent
16219854|NCT01239641|Procedure|High intensity focused ultrasound|The term 'high intensity focused ultrasound' means using ultrasound to causes coagulation necrosis to destroy the targeted tissue, in this case, uterine fibroids.
16219855|NCT01239563|Drug|antithymocyte globulin|Thymoglobulin 1.5mg/kg, 4 doses Thymoglobulin 6mg/kg, single dose
16219856|NCT01239563|Drug|Basiliximab|Intravenous 20mg, day 0&4
16219857|NCT01239550|Drug|Detemir|"Subjects randomized to insulin detemir treatment group will receive the basal insulin in a 3 mL. Flex Pen® containing 300 units of insulin. insulin detemir once daily administered with the evening meal (dinner) or at bedtime as add-on to their oral antihyperglycemia (see inclusion/exclusion criteria) meds throughout the 24 week treatment period. The goal of insulin therapy is to achieve near normoglycemia with a low rate of hypoglycaemic episodes.
~Insulin injections will be given subcutaneously preferably in the thigh or abdomen."
16219858|NCT01239537|Drug|Seasonal Flu vaccine|1 dose of seasonal trivalent flu vaccine (Fluarix)
16219859|NCT01239524|Procedure|denervation of thoracodorsal nerve or saving the nerve|
16219860|NCT01239511|Drug|green tea polyphenols (STA-2)|2 capsules t.i.d., after meal
16220928|NCT01231516|Drug|GSK1349572 Placebo|Inactive placebo tablet once daily
16219861|NCT01239498|Procedure|Injection of Saline + Lidocaine/Adrenaline|"All anaesthetic injections will consist of xylocaine 1% with 1:100,000 adrenaline and will be administered through a short 30 Gauge needle at a constant slow speed at multiple (6-7) sites along the upper lid by a single oculoplastic consultant.
~The experimental eyelid will receive a saline-consisted injection 0.5cc prior to the administration of the anesthetic injection.
~Injection of Saline + Lidocaine 1%"
16219862|NCT01239498|Procedure|Lidocaine/Adrenaline only|Injection of Lidocaine/Adrenaline only
16219863|NCT01239485|Drug|Irinotecan|"Chemotherapy: irinotecan, etoposide, and cytarabine daily for 5 days (on days 0, 1, 2, 3, & 4) -30 min: Atropin ivs 0 hour: irinotecan X mg/m2 in D5W 100 mL IV over 60 min 0 hour: etoposide 100 mg/m2 in x3 N/S mL IV over 60 min 12 hour: cytarabine 2,000 mg/m2 over 3 hr
~*if age ≤ 3 yrs: calculate all drugs in kg base (30kg=1m2) Irinotecan dose is escalated by 25-30% in successive cohorts. The starting irinotecan dose (level 1) is 20 mg/m2/dose on days 0 to 4."
16219864|NCT01239472|Drug|Everolimus|Replacement of tacrolimus by everolimus, 30 days after transplat. It was done after kidney biopsy (excluding acute rejection), blood and urine analysis.
16219865|NCT01239459|Drug|Teriflunomide HMR1726|"Pharmaceutical form:film coated tablet
~Route of administration: oral administration on Day 1 under fasted condition"
16219866|NCT01239459|Drug|Cholestyramine|"Pharmaceutical form:powder
~Route of administration: oral administration 3 times per day on Day 54 and 55"
16219867|NCT01239446|Other|Not relevant (there is no intervention in the present study)|Not relevant (there is no intervention in the present study)
16219868|NCT01239407|Behavioral|Culturally focused psychiatric consultation|"The consultation is comprised of 3 visits:
~1a. Psychiatric diagnostic interview, self-rated questionnaires (in-person consultation).
~1b. Intervention focused on learning about depression and how to treat it using culturally relevant resources.
~2. Follow-up visit two weeks later to go over patients' questions, homework if applicable, and patients' ability to meet the goals outlined in the first visit (in-person or phone visit).
~3. 6-month follow up: 6 months after the initial consultation, patients are asked about mental health symptoms and mental health treatment they might be receiving (phone visit unless patient requests in-person)."
16219869|NCT01239394|Drug|ofatumumab|Weekly infusion for 8 weeks
16219870|NCT01239381|Radiation|Stereotactic body radiotherapy-proton|Dose will be determined by the size and location of the tumor(s); 2-3 treatments per week for two weeks
16219871|NCT01239368|Procedure|Adoptive Immunotherapy|Th1 (type 1 T helper cells)/Tc1 (T cytotoxic cells, type 1) Rapa cell infusion will be evaluated after administration of a 7-day or 14-day course of immune depleting chemotherapy (pentostatin plus cyclophosphamide regimen).
16219872|NCT01239368|Biological|Rapamycin-Generated Autologous Th1/Tc1 Cells (modified primary human T cells)|Six Th1/Tc1 Rapa cell doses will be tested in cohorts of 1-6 subjects each: ranging from 10e(5) to 15 x 10e(6) cells/kg of body weight.
16219873|NCT01239368|Biological|Th1/Tc1 Rapa Cell Therapy|Th1/Tc1Rapa: 5 x 10e(6) cells/kg
16219874|NCT01239355|Drug|Akt Inhibitor MK2206|Given PO
16219875|NCT01239355|Other|Laboratory Biomarker Analysis|Correlative studies
16219876|NCT01239342|Drug|Akt Inhibitor MK2206|Given PO
16219877|NCT01239342|Drug|Everolimus|Given PO
16219878|NCT01239342|Other|Laboratory Biomarker Analysis|Optional correlative studies
16219879|NCT01239316|Other|Laboratory Biomarker Analysis|Correlative studies
16219880|NCT01239316|Other|Pharmacological Study|Correlative studies
16219881|NCT01239316|Drug|Vismodegib|Given PO
16219882|NCT01239303|Dietary Supplement|Citrulline|single dose
16219883|NCT01239303|Dietary Supplement|alanine|single dose
16219884|NCT01239277|Other|protein|20g protein
16219885|NCT01239277|Other|protein and carbohydrate|20g protein and 20g carbohydrate
16219886|NCT01239277|Other|protein and leucine|20g protein, 2.5g leucine
16219887|NCT01239251|Other|GlowCap device|Participants will be provided with a device called the GlowCap for a period of 30 days. The device has visual and auditory cues to help patients remember to take their medication at the same time each day. The GlowCap will be programmed to glow when it is time for each patient to take her medication. The GlowCap will initially glow bright orange for the first hour from the time the patient is scheduled to take the medication. During the second hour, the GlowCap system will play music in addition to continuing to glow. If after 2 hours the patient still has not opened the medication bottle, she will receive a phone call reminding her to take her medication.
16219888|NCT01239225|Device|Abdominal ultra-sound|
16219889|NCT01239225|Procedure|Abdominal ultrasound|
16219890|NCT01239212|Drug|levetiracetam|50 mg/kg single loading dose of IV levetiracetam
16219891|NCT01239199|Other|Measure of the exhaled NO|The exhaled NO will be measure by chemiluminescence in current ventilation by an indirect method (off-line)
16219892|NCT01239186|Other|methylation analyses on spermatozoa from infertile men|microarray analysis(www.EPIGENOMICS.com)
16219893|NCT01239173|Drug|AVLOCARDYL|A grip of 2 tablets of 20 mg each took 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI
16219894|NCT01239173|Drug|Placebo|A grip of 2 tablets of 20 mg each took 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI
16219895|NCT01239173|Drug|AVLOCARDYL|A grip of 2 tablets of 20 mg each took 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI
16219896|NCT01239173|Drug|Placebo|A grip of 2 tablets of 20 mg each took 90 min before the emotional memory reactivation and the anatomical and functional exploration in fMRI
16219897|NCT01239160|Device|Flexitouch System|"A segmental, programmable, gradient pneumatic compression device. It consists of a controller and garment set. The garments are constructed of nylon and have 27-32 chambers, depending upon garment size. The pressure setting is variable between normal and increased. The device is intended to be used for 60 minutes per day"
16219898|NCT01239160|Device|Hydroven FPR|The FH is an intermittent sequential external pneumatic compression system. The garment contains 3 compression chambers. The pressure range of the compressor device is 30-100 mmHg. It is intended to be used for 60 minutes per day.
16219899|NCT01239147|Other|Diet rich in whole grain|Ready-to-eat breakfast cereals and other cereal products, rich in whole grain
16219900|NCT01239147|Other|Refined grain|Ready-to-eat breakfast cereals and other cereal products, low in whole grain
16220929|NCT01231516|Drug|Raltegravir Placebo|Inactive placebo tablet twice daily
16219901|NCT01239134|Biological|TRX518|Humanized, Fc disabled, anti-human GITR (glucocorticoid-induced tumor necrosis factor receptor) monoclonal antibody
16219902|NCT01239121|Other|HIE-Enhanced Medication Reconciliation|Medication reconciliation enhanced by regional health information exchange, implemented by a pharmacist
16219903|NCT01239121|Other|Optimal Medication Reconciliation without HIE|Medication reconciliation implemented by a pharmacist without regional health information exchange
16219904|NCT01239108|Drug|SGI-1776|SGI-1776 will be administered orally at escalating dose levels ranging from 350 to 1600 mg/day based on the dose escalation levels of the ongoing, first-in-human study.
16219905|NCT01239095|Drug|Green Tea and Milk Thistle Supplements|Green Tea Extract: 3,200 mg per day Milk thistle extract with phosphatidylcholine: 2,700 mg per day
16219906|NCT01239082|Procedure|Colonoscopy|One time screening Colonoscopy to screen for colorectal cancer
16219907|NCT01239082|Procedure|FIT|Annual FIT testing
16219908|NCT01239069|Drug|DE-110 ophthalmic suspension high dose|ophthalmic suspension; high dose; QID
16219909|NCT01239069|Drug|DE-110 ophthalmic suspension low dose|ophthalmic suspension; low dose; QID
16219910|NCT01239069|Other|Placebo|DE-110 ophthalmic suspension vehicle;QID
16219911|NCT01239056|Procedure|Endoscopy|Endoscopic drainage of a pancreatic pseudocyst using a metal stent per medical indication.
16219912|NCT01239043|Biological|Menomune®: A, C, Y, W 135 Meningococcal Polysaccharide|0.5 mL, Subcutaneous
16219913|NCT01239043|Biological|Menactra®: Meningococcal (A, C, Y and W 135) Polysaccharide Diphtheria Toxoid Conjugate|0.5 mL, Intramuscular
16219914|NCT01239030|Drug|Methylphenidate Hydrochloride Extended Release Capsules|Biphentin Methylphenidate ER Once-A-Day Capsules
16219915|NCT01239017|Biological|REGN475|
16219916|NCT01239017|Other|Placebo|
16219917|NCT01239004|Drug|Placebo|6 tablets daily, with up to 2000 mg niacin and 325 mg aspirin daily, for 12 weeks
16219918|NCT01239004|Drug|Colesevelam|6 tablets (3750 mg total) daily, with up to 2000 mg niacin and 325 mg aspirin daily, for 12 weeks
16219919|NCT01238991|Biological|ACC-001|IM injection, dose of 3 micrograms, at Day 1, month 6, 12 and 18
16219920|NCT01238991|Biological|ACC-001|IM injection, dose of 10 micrograms, at Day 1, month 6, 12 and 18
16219921|NCT01238991|Biological|ACC-001|IM injection, dose of 30 micrograms, at Day 1, month 6, 12 and 18
16219922|NCT01238978|Drug|Vildagliptin|
16219923|NCT01238978|Drug|"Usual Care"|
16219924|NCT01238965|Drug|panobinostat|Given orally
16219925|NCT01238965|Drug|fluorouracil|Given IV
16219926|NCT01238965|Drug|leucovorin calcium|Given IV
16219927|NCT01238965|Procedure|biopsy|Correlative studies
16219928|NCT01238965|Genetic|reverse transcriptase-polymerase chain reaction|Correlative studies
16219929|NCT01238965|Genetic|western blotting|Correlative studies
16219930|NCT01238965|Other|laboratory biomarker analysis|Correlative studies
16219931|NCT01238965|Genetic|gene expression analysis|Correlative studies
16219932|NCT01238965|Genetic|RNA analysis|Correlative studies
16219933|NCT01238965|Genetic|polymorphism analysis|Correlative studies
16219934|NCT01238952|Drug|NK012 and carboplatin|NK012 and carboplatin via infusion once every 28 days
16219935|NCT01238939|Drug|NK012 and 5-FU|NK012 infusion on Day 1 of each 28 day cycle 5-FU continuous infusion on Days 1 and 15 of each 28 day cycle
16219936|NCT01238926|Dietary Supplement|PD vitamin supplementation|25 mg/day of Vitamin B6 2,000 mcg/day of Vitamin B12 5 mg/day of Folic Acid
16219937|NCT01238926|Other|PD exercise intervention|Cardiovascular training (treadmill and StairMaster), 20 min; and strength training (2 sets of 15 repetitions of 60-70% of 1 repetition maximum [RM]) using machines that provide the following motions: knee extension, knee flexion, leg press, elbow flexion, elbow extension, seated dip.
16219938|NCT01238926|Other|PD vitamin + exercise|25 mg/day of Vitamin B6 2,000 mcg/day of Vitamin B12 5 mg/day of Folic Acid Cardiovascular training (treadmill and StairMaster), 20 min; and strength training (2 sets of 15 repetitions of 60-70% of 1 repetition maximum [RM]) using machines that provide the following motions: knee extension, knee flexion, leg press, elbow flexion, elbow extension, seated dip.
16219939|NCT01238913|Procedure|Endoscopy|Endoscopic placement of an esophageal metal stent as per medical indication.
16219940|NCT01238900|Procedure|Endoscopic Retrograde Cholangiopancreatography (ERCP)|Endoscopic Retrograde Cholangiopancreatography (ERCP) with placement of metal stent in the bile duct
16219941|NCT01238887|Dietary Supplement|Microcrystalline Cellulose placebo pill|Participants will be given gelatin capsules containing the placebo (microcrystaline cellulose) and will be instructed to consume four capsules three times daily (30 minutes before breakfast, lunch, and dinner) with a glass of water. This will equal 3000 mg/day of the placebo contents. Participants will be instructed to follow this dosing regimen throughout the six week treatment period.
16219942|NCT01238887|Dietary Supplement|Garcinia cambogia-derived hydroxycitric acid (2800 mg/day)|The hydroxycitric acid treatment is derived from garcinia cambogia and is provided by the company, Glykon Technologies. In this condition, participants will receive HCA at a dosage of 2,800 mg/day in the form of gelatin capsules. Participants will be instructed to consume four capsules three times daily (30 minutes before breakfast, lunch, and dinner) with a glass of water. Participants will be instructed to follow this dosing regimen throughout the six week treatment period.
16219943|NCT01238887|Dietary Supplement|Garcinia Cambogia derived Hydroxycitric Acid|The hydroxycitric acid treatment is derived from garcinia cambogia and is provided by the company, Glykon Technologies. In this condition, participants will receive HCA at a dosage of 5,400 mg/day in the form of gelatin capsules. Participants will be instructed to consume four capsules three times daily (30 minutes before breakfast, lunch, and dinner) with a glass of water. Participants will be instructed to follow this dosing regimen throughout the six week treatment period.
16219944|NCT01238874|Device|Cardiac Resynchronization Therapy|All market-approved Medtronic CRT-D and CRT-P devices will be used in this study. All eligible devices are commercially released and will be used within their intended use per device labeling. The study may include future market-approved devices as they become commercially available. All market-approved leads may be used in the study. Epicardial leads may be used in the study.
16219945|NCT01238861|Biological|Benralizumab 2 mg|EOS+ participants received single benralizumab 2 milligram (mg) injection followed by a single placebo injection subcutaneously.
16219946|NCT01238861|Biological|Benralizumab 20 mg|EOS+ participants received single benralizumab 20 mg injection followed by a single placebo injection subcutaneously.
16219947|NCT01238861|Biological|Benralizumab 100 mg|EOS+ and EOS- participants received two benralizumab 50 mg injections subcutaneously.
16219948|NCT01238861|Other|Placebo|EOS+ and EOS- participants received two placebo injections subcutaneously.
16219949|NCT01238848|Drug|Hypertonic saline|3 cc nebulized hypertonic saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days
16219950|NCT01238848|Drug|Normal saline|3 cc nebulized normal saline + albuterol 0.25 mg/kg/day, four times a day (QID), 5 days
16219951|NCT01238835|Device|SAPIEN XT™ Transapical aortic valve replacement|Transcatheter aortic valve implantation via the transapical approach
16219952|NCT01238822|Drug|Methylphenidate|18 mg methylphenidate
16219953|NCT01238822|Drug|placebo|Placebo
16219954|NCT01238822|Drug|Methylphenidate|36 mg methylphenidate
16219955|NCT01238822|Drug|Methylphenidate|54 mg methylphenidate
16219956|NCT01238796|Drug|telavancin|Intravenous
16219957|NCT01238783|Drug|AL-15469A 0.5% and AL-6515 0.3% Ophthalmic Suspension|Topical ocular dosed 3 times per day for 3 days
16219958|NCT01238783|Drug|AL-15469A 0.5%|Topical ocular dosed 3 times per day for 3 days
16219959|NCT01238783|Drug|AL-6515 0.3%|Topical ocular dosed 3 times per day for 3 days
16219960|NCT01238783|Drug|Vehicle|Topical ocular dosed 3 times per day for 3 days
16219961|NCT01238770|Drug|Pazopanib|"Phase I Cyclophosphamid Pazopanib Dose level I 50 mg/day 400 mg/day Dose level II 50 mg/day 600 mg/day Dose level III 50 mg/day 800 mg/day
~Cyclophosphamide 50 mg daily orally Pazopanib 400, 600 or 800 mg daily orally
~Phase II:
~Cyclophosphamide 50 mg daily orally Pazopanib 400, 600 or 800 mg daily orally The dose for the phase II part of the trial will be based on the MTD of phase I."
16219962|NCT01238757|Other|Non-invasive Ventilation under Pressure Support|"Non-invasive Ventilation under Pressure Support:
~15 min with initial settings, 5 min with ETS-%%, 5 min with ETS+10%, in random order"
16219963|NCT01238757|Other|Non-Invasive ventilation under NAVA|20 min session under non-invasive ventilation with NAVA
16219964|NCT01238744|Dietary Supplement|Flaxseed drink|Drink containing flaxseed mucilage
16219965|NCT01238744|Dietary Supplement|Flaxseed drink|Drink containing flaxseed mucilage
16219966|NCT01238744|Dietary Supplement|Flaxseed tablet|Tablets containing flaxseed mucilage consumed with a control drink
16219967|NCT01238744|Dietary Supplement|Control drink|Control drink
16219968|NCT01238718|Drug|Lidocaine|lidocaine 1.5 mg/kg intravenously
16219969|NCT01238718|Drug|Placebo|normal saline
16219970|NCT01238705|Drug|Felodipine add Irbesartan|"Felodipine Sustained Release Tablets,5mg/day,AstraZeneca Pharmaceutical Co.Ltd., Registration Number: H20030415.
~Irbesartan,150mg/day, Sanofi - Aventis Pharmaceutical company, Registration Number: H20080074."
16219971|NCT01238705|Drug|Felodipine add Metoprolol|"Felodipine Sustained Release Tablets,5mg/day,AstraZeneca Pharmaceutical Co.Ltd., Registration Number: H20030415.
~Metoprolol Succinate,47.5mg/day,AstraZeneca Pharmaceutical Co.Ltd., Registration Number: J20050061."
16219972|NCT01238692|Drug|LBH589|Patients randomized to both arms will receive oral LBH589, once-a-day, at a dose of 30 mg/day, on a three times-a-week (Monday, Wednesday and Friday) schedule as part of a 3 week (21 day) treatment cycle. Day one of each cycle will be on a Monday.
16219973|NCT01238692|Drug|Rituximab|"Patients randomized to Arm B will receive IV rituximab at a dose of 375 mg/m2 in combination with oral LBH589. Rituximab should be administered on the same day as LBH589, after the patient has taken their LBH589 dose. The appropriate amount of solution should be withdrawn from the vial for the following calculation:
~Volume (mL) = BSA (m2) × dose (375 mg/m2) / concentration of reconstituted solution ml/mL (100 mg/10 mL and/or 500 mg/50 mL)."
16219974|NCT01238679|Drug|PF-04958242|Administered as specified in the treatment arm
16219975|NCT01238679|Drug|Placebo|Administered as specified in the treatment arm
16219976|NCT01238640|Drug|Code STD|"2 mg Single-dose of experimental nicotine product coded STD"
16219977|NCT01238640|Drug|Code STE|"2 mg Single-dose of experimental nicotine product coded STE"
16219978|NCT01238640|Drug|Nicorette Microtab|A comparative 2 mg Single-dose of marketed tablet
16219979|NCT01238627|Drug|Nicotine Sublingual Tablet Mint (NSTM)|A single dose of an experimental NSTM, with a 36-hour washout between visits
16219980|NCT01238627|Drug|Marketed Nicotine Tablet|A single dose of a marketed Nicotine Replacement Therapy (NRT), with a 36-hour washout between visits
16219981|NCT01238614|Other|CHICA PSF plus JIT|
16219982|NCT01238614|Other|CHICA maternal depression PSF|
16219983|NCT01238614|Other|Control|
16219984|NCT01238588|Drug|Sevelamer Carbonate (Renvela)|Patients' will be given doses of Renvela equivalent to their prior dose of calcium based phosphate binders and the dose will be titrated as necessary to achieve phosphate levels recommended by KDOQI guidelines.
16219985|NCT01238575|Other|placebo|Administered for up to 8 weeks.
16219986|NCT01238575|Drug|extended-release guanfacine|1 mg tablets; flexible dosing up to 4 mg/day for up to 16 weeks
16219987|NCT01238562|Drug|YPEG-Filgrastim|s.c, single dose of 10mcg/kg of YPEG-Filgrastim at 48hr of cycle 2, followed by daily s.c either 2.5 mcg/kg or 5 mcg/kg of filgrastim(TOPNEUTER) starting from 48hr of cycle 3 until WBC≥10,000 per cubic milliliter or ANC≥5,000 per cubic milliliter in two continuous daily tests after ANC nadir.
16219988|NCT01238562|Drug|YPEG-Filgrastim|s.c, single dose of 20mcg/kg of YPEG-Filgrastim at 48hr of cycle 2, followed by daily s.c either 2.5 mcg/kg or 5 mcg/kg of filgrastim(TOPNEUTER) starting from 48hr of cycle 3 until WBC≥10,000 per cubic milliliter or ANC≥5,000 per cubic milliliter in two continuous daily tests after ANC nadir.
16219989|NCT01238562|Drug|YPEG-Filgrastim|s.c, single dose of 30mcg/kg of YPEG-Filgrastim at 48hr of cycle 2, followed by daily s.c either 2.5 mcg/kg or 5 mcg/kg of filgrastim(TOPNEUTER) starting from 48hr of cycle 3 until WBC≥10,000 per cubic milliliter or ANC≥5,000 per cubic milliliter in two continuous daily tests after ANC nadir.
16219990|NCT01238562|Drug|YPEG-Filgrastim|s.c, single dose of 45mcg/kg of YPEG-Filgrastim at 48hr of cycle 2, followed by daily s.c either 2.5 mcg/kg or 5 mcg/kg of filgrastim(TOPNEUTER) starting from 48hr of cycle 3 until WBC≥10,000 per cubic milliliter or ANC≥5,000 per cubic milliliter in two continuous daily tests after ANC nadir
16220071|NCT01237951|Drug|Melphalan|60 mg/m^2 IV on Days -3 and -2 over 30 minutes on both days as an outpatient or inpatient.
16219991|NCT01238562|Drug|YPEG-Filgrastim|s.c, single dose of 60mcg/kg of YPEG-Filgrastim at 48hr of cycle 2, followed by daily s.c either 2.5 mcg/kg or 5 mcg/kg of filgrastim(TOPNEUTER) starting from 48hr of cycle 3 until WBC≥10,000 per cubic milliliter or ANC≥5,000 per cubic milliliter in two continuous daily tests after ANC nadir.
16219992|NCT01238536|Procedure|Epidural steroid with local anesthetic injection|Epidural steroid injectate will be 2cc of 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.
16219993|NCT01238536|Procedure|Epidural local anesthetic injection|Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.
16219994|NCT01238536|Drug|Epidural steroid injection|Epidural steroid injectate will be 2cc of .25 - 1% lidocaine followed by 1-3 cc of 40 mg/cc Kenalog (i.e. 40-120 mg Kenalog) or an equivalent steroid medication (depo-medrol 60-120 mg, betamethasone 6-12 mg or dexamethasone 8-10 mg) in an opaque syringe.
16219995|NCT01238536|Drug|Epidural local anesthetic injection|Epidural injectate will be 2cc of .25-1% lidocaine followed by 1-3cc of 1% lidocaine in an opaque syringe.
16219996|NCT01238523|Procedure|Long leg cast in full extension|Long leg cast in full extension with instructions to begin immediate weight bearing as tolerated on the injured extremity
16219997|NCT01238523|Procedure|Long leg cast with 45 degrees of flexion|Long leg cast with 45 degrees of flexion at the knee with instructions not to bear weight on the injured extremity
16219998|NCT01238510|Procedure|stent technique: Provisional fKBT|"Provisional use of fKBT only when SB flow is aggravated to TIMI0-2 after stenting for non-left main bifurcation.
~Additional stenting for SB is recommended if residual stenosis (>50% in visual) or TIMI flow grade (<TIMI 3) was seen at SB after fKBT.
~Stent type: Everolimus-eluting stent only"
16219999|NCT01238510|Procedure|stent technique: Routine fKBT|"Mandatory use of fKBT irrespective of SB flow after stenting for non-left main bifurcation. Additional stenting for SB is recommended if residual stenosis (>50% in visual) or TIMI flow grade (<TIMI 3) was seen at SB after fKBT.
~Stent type: Everolimus-eluting stent only"
16220000|NCT01238497|Device|TAVR Implantation of the Transcatheter Aortic Valve Prosthesis|Patients eligible for either transfemoral or transapical access and any of the 3 valve sizes (23, 26 or 29)
16220001|NCT01238497|Device|TAVR Implantation of the Transcatheter Aortic Valve Prosthesis|Patients eligible for transapical or transaortic access and any of the 3 valve sizes (23mm, 26mm or 29mm)
16220002|NCT01238497|Device|TAVR Implantation of the Transcatheter Aortic Valve Prosthesis|Patients eligible for transfemoral access and requiring a 29mm valve.
16220003|NCT01238484|Other|Standard of care|shoe modification home stretching exercises
16220004|NCT01238484|Device|Dynasplint|shoe modification home stretching exercises Ankle Dorsiflexion Dynasplint
16220005|NCT01238471|Drug|propranolol|2 mg per kg per day divided in 3 doses for 2-4 weeks
16220006|NCT01238471|Drug|sucrose 5%|2 ml per Kg per day divided in 3 doses for 2-4 weeks
16220007|NCT01238458|Drug|[18F]AV-45 PET amyloid binding imaging|"This study will recruit a total of 150 evaluable subjects (30 cognitively normal volunteers, and 60 MCI, and 60 AD, respectively) Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject grouping.
~Safety measurement will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events."
16220008|NCT01238419|Device|Physiotulle|Physiotulle is a non adherent dressing, composed of a polyester fabric impregnated with hydrocolloid particles (CMC) suspended in vaseline
16220009|NCT01238419|Device|URGOTUL|Urgotul is an non occlusive dressing comprising of a polyester mesh impregnated with hydrocolloid particles dispersed on a petroleum jelly matrix
16220010|NCT01238406|Device|MD-logic Artificial Pancreas (MDLAP)|Treatment with the closed loop MD-logic Artificial Pancreas(MDLAP)System
16220011|NCT01238406|Device|Standard treatment with insulin pump|Standard treatment with sensor augmented pump therapy
16220012|NCT01238393|Drug|intravitreal ranibizumab|monthly injections x3 +/- 2nd series of 3
16220013|NCT01238380|Other|patient care pathway|"Stage 1: Urinary c-peptide creatinine ratio (UCPCR); if positive progress to Stage 2.
~Stage 2: Pancreatic auto-antibodies measurement (GAD65 & IA2); if negative progress to genetic testing.
~Genetic testing for HNF1A, HNF4A, GCK. If positive, progress to Stage 3.
~Stage 3: review and potential change of diabetes treatment. Monitor success via use of three standardised health and quality of life questionnaires and Hba1c pre-treatment change and at 1, 3, 6 and 12 months post-treatment change."
16220014|NCT01238367|Drug|turoctocog alfa|Subjects will receive recombinant factor VIII (N8) at a dose of 50 +/- 5 IU/kg body weight. Intravenous administration as a single bolus injection.
16220015|NCT01238354|Behavioral|With friend|
16220016|NCT01238354|Behavioral|Without friend|
16220017|NCT01238341|Procedure|Endoscopic Retrograde Cholangiopancreatography (ERCP)|An Endoscopic Retrograde Cholangiopancreatography (ERCP) performed with an overtube in the evaluation of pancreatobiliary disease in patients with altered gastric anatomy
16220018|NCT01238328|Drug|Conditioning regimen|"For sibling full match:
~Busulfan 16 mg/kg >5year - 20 mg/kg <5year po
~Cyclophosphamide 200 mg/kg iv
~For other related full match, sibling or other related with one antigen mismatch and umbilical cord blood:
~Busulfan 16 mg/kg >5year - 20 mg/kg <5year po
~Cyclophosphamide 200 mg/kg iv
~Antithymocyte globulin (ATG) rabbit (Thymoglobulin) 10 mg/kg or ATG horse (Atgam) 40 mg/kg
~For haploidentical:
~Busulfan 16 mg/kg >5year - 20 mg/kg <5year po
~Cyclophosphamide 200 mg/kg iv
~Fludarabine 160 mg/m^2"
16220019|NCT01238328|Drug|Graft-versus-host disease (GVHD) prophylaxis|"Cyclosporin A 1.5 mg/kg/day iv from -2, then 3 mg/kg/day iv (from +7 in peripheral blood stem cell transplant (PBSCT) and +11 in Bone marrow transplantation or Umbilical Cord Blood (UCB) transplantation) then 9 mg/kg/day po
~10 mg/m^2 iv day +1 then 6 mg/m^ iv day +3 and +6 (Not for UCBT)"
16220020|NCT01238328|Procedure|Stem Cell Transplantation|"Patients undergoing Hematopoietic Stem Cell Transplantation from one of below source:
~Sibling full match
~Other related full match
~Sibling or other related with 1 mismatch antigen
~Cord Blood
~Haploidentical"
16220021|NCT01238315|Biological|HuCNS-SC|Surgery to implant human CNS stem cells
16220069|NCT01237951|Drug|Gemcitabine|1875 mg/m^2 IV (75 mg/ m2 bolus followed by 1800 mg/m^2 over 3 hours) on Day -8 and Day -3 as an outpatient or inpatient.
16220070|NCT01237951|Drug|Busulfan|"32 mg/m2 test dose with PKs as outpatient before Day -12, or as an inpatient on Day -10.
~Busulfan AUC 4,000 by vein on Days -8 to -5 as an outpatient or inpatient."
16220022|NCT01238302|Procedure|Conventional arthroscopic rotator cuff repair|"Under general anesthesia, the patient was placed in the lazy lateral decubitus position on the operating table.
~The surgical area was prepared and draped with Betadine.
~Small stab incisions were made in the creation of 4-5 portals as needed.
~A scope was explored via the arthroscopic portal into the GH joint & subacromial space.
~Repair of full thickness rotator cuff tear was done with suture anchors.
~The skin was closed with Nylon or medical staples.
~Sterile dressing was applied on surgical wound."
16220023|NCT01238302|Procedure|Arthroscopic rotator cuff repair with PRP|"Under general anesthesia, the patient was placed in the lazy lateral decubitus position on the operating table.
~The surgical area was prepared and draped with Betadine.
~Small stab incisions were made in the creation of 4-5 portals as needed.
~A scope was explored via the arthroscopic portal into the GH joint & subacromial space.
~Repair of full thickness rotator cuff tear was done with suture anchors.
~After tying sutures of the medial row, PRP gels were applied on the repair site.
~The lateral row was secured using suture anchors.
~The skin was closed with Nylon or medical staples.
~Sterile dressing was applied on surgical wound."
16220024|NCT01238289|Behavioral|Peer Education|Conduct peer education classes for 8 weeks and support groups monthly for a total of 10 months and evaluate effects on metabolic and behavior outcomes
16220025|NCT01238289|Behavioral|Control|This group continues with standard care at the community health center
16220026|NCT01238276|Drug|Cefazolin|Cefazolin is approved for clinical use for some bacterial infections. The standard routes of administration are Intramuscular (IM) and intravenous (IV). For this study, the route of administration will be delivered using the Silberg TPS, which delivers the cefazolin by subcutaneous injection followed by external ultrasonic dispersion. The concentration delivered is one gram/100 ml saline. Cefazolin can safely be given IM at the much higher concentration of 1 gram/2.5 ml of saline. The maximum dose that may be administered is 3 grams in 300 ml, which is within the approved guidelines of a daily dose. The concentration of antibiotic will be the same; only the dose may vary depending on the size of the wound or area of induration. Each subject will receive only one treatment in this study.
16220027|NCT01238276|Device|Silberg Tissue Preparation System|The TPS is FDA cleared for the subcutaneous infusion and ultrasonic dispersion of tumescent fluid excluding the parenteral delivery of drugs. Under this study, the TPS is a device to deliver cefazolin by subcutaneous injection followed by external ultrasonic dispersion. The TPS consists of a medical grade peristaltic pump that is used to infuse antibiotic solution using a sterile blunt-tipped infusion cannula into a superficial subcutaneous plane. After the cannula has been removed, high frequency external ultrasound is delivered transcutaneously over the area of infusion in order to disperse the antibiotic solution. The power density is within the range allowed for physical therapy.
16220028|NCT01238237|Drug|Superselective Intraarterial Cerebral Infusion of Cetuximab|Intraarterial Mannitol 25% 3-10 ml to open the blood brain barrier followed by Intraarterial Cetuximab single dose (starting at 100mg/m2 and escalating up to 500mg/m2)
16220029|NCT01238224|Drug|Tadalafil|This is an acute study. Tadalafil 20 mg administered prior to a meal
16220030|NCT01238211|Drug|Cytarabine|Given IV
16220031|NCT01238211|Drug|Dasatinib|Given PO
16220032|NCT01238211|Drug|Daunorubicin Hydrochloride|Given IV
16220033|NCT01238211|Other|Laboratory Biomarker Analysis|Correlative studies
16220034|NCT01238185|Drug|acetylsalicylic acid|
16220035|NCT01238185|Genetic|gene expression analysis|
16220036|NCT01238185|Genetic|protein expression analysis|
16220037|NCT01238185|Other|laboratory biomarker analysis|
16220038|NCT01238185|Other|questionnaire administration|
16220039|NCT01238185|Procedure|biopsy|
16220040|NCT01238172|Other|dietary education and counseling|
16220041|NCT01238172|Other|prostate cancer foundation booklet|
16220042|NCT01238159|Radiation|CCRT+MIDLE chemotherapy|Patients are planned to be treated with CCRT plus MIDLE chemotherapy
16220043|NCT01238146|Drug|bendamustine hydrochloride|Given IV
16220044|NCT01238146|Drug|obatoclax mesylate|Given IV
16220045|NCT01238146|Biological|rituximab|Given IV
16220046|NCT01238133|Drug|Carboplatin|Given IV
16220047|NCT01238133|Drug|Gamma-Secretase Inhibitor RO4929097|Given PO
16220048|NCT01238133|Other|Laboratory Biomarker Analysis|Correlative studies
16220049|NCT01238133|Drug|Paclitaxel|Given IV
16220050|NCT01238133|Other|Pharmacological Study|Ancillary studies
16220051|NCT01238133|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16220052|NCT01238120|Drug|Ibuprofen|200 mg BID and 8 hours apart
16220053|NCT01238120|Behavioral|Home-Based Exercise|A progressive walking and resistance band exercise program called Exercise for Cancer patient (EXCAP) for a 6 week period
16220054|NCT01238120|Drug|Placebo|200mg BID and 8 hours apart
16220055|NCT01238107|Drug|MT-102|BETA BLOCKER
16220056|NCT01238094|Drug|Simvastatin|simvastatin 40 mg qd daily until disease progression
16220057|NCT01238068|Device|gamma nail stryker|for acute unstable pertrochantric fractures the subjects will be treated randomaly with either Gamma nail device Vs Dynamic hip screw
16220058|NCT01238055|Drug|Docetaxel + Sunitinib|"Docetaxel 60 mg/m2 iv, every 3 weeks
~Sunitinib 37.5 mg qd daily, every 3 weeks"
16220059|NCT01238055|Drug|Docetaxel only|Docetaxel 60 mg/m2 iv
16220060|NCT01238042|Drug|HPPH|3mg/m2 or 4 mg/m2 at light doses of 150, 175 and 200 joules/cm
16220061|NCT01238029|Drug|Lapatinib and Capecitabine and Vinorelbine|Dose finding Study Lapatinib: 1000-1250 oral, once daily, days 1-21 Capecitabine: 1000 mg/sqm oral, bid, days 1-14 Vinorelbine 10-22,5 mg/sqm, i.v. Day 1 + 8
16220062|NCT01238016|Device|experimental|
16220063|NCT01238003|Other|Interpretation of blood test results|Interpretation of blood test results
16220064|NCT01237977|Drug|Botulinum Toxin Type A(Meditoxin®)|single administration, Day 0, 20U
16220065|NCT01237977|Drug|Botulinum Toxin Type A(Botox®)|single administration, Day 0, 20U
16220066|NCT01237964|Drug|Xiaflex (FDA approved collagenase)|0.58mg of collagenase will be diluted in saline and injected in 3 points surrounding the limiting contracture
16220067|NCT01237951|Drug|Palifermin|"60 micrograms/kg infused as an IVP (by vein) over 15-30 seconds Days -12 to -10 and Days 0 to +2 as an outpatient.
~60 micrograms/kg by vein on Days -13 to -11 and on Days 0, +1 and +2 as in inpatient."
16220119|NCT01237496|Drug|peginterferon alfa-2a [Pegasys]|180 mcg sc weekly
16220072|NCT01237951|Procedure|Stem Cell Transplant|On Day 0, stem cells returned to body by vein over 30-60 minutes.
16220073|NCT01237951|Drug|G-CSF|5 mcg/kg/day subcutaneously beginning on Day +5 and continuing until neutrophil recovery is documented.
16220074|NCT01237938|Behavioral|Low Glycemic Diet|Changing to low glycemic diet
16220075|NCT01237925|Drug|Dexchlorpheniramine 1% gel|Small amount applied over the lesion twice a day for 7 days
16220076|NCT01237925|Drug|Dexchlorpheniramine 1% cream|Small amount applied over the lesion twice a day for 7 days
16220077|NCT01237899|Drug|LY2623091|Administered orally.
16220078|NCT01237899|Drug|Placebo|Administered orally.
16220079|NCT01237899|Drug|Eplerenone|Administered orally.
16220080|NCT01237873|Drug|Ali/Amlo 150/2.5 mg|Aliskiren/Amlodipine 150/2.5 mg and 150/5.0 mg
16220081|NCT01237860|Device|NESS L300 Plus System|The patients will receive the device for daily use of six (6) weeks.
16220082|NCT01237847|Behavioral|2 Family-based problem solving phone sessions|2 family-based problem solving phone sessions to address and ameliorate barriers to adherence.
16220083|NCT01237847|Behavioral|4 Family-based problem solving phone intervention sessions|4 family-based problem solving phone sessions to address and ameliorate barriers to adherence.
16220084|NCT01237847|Behavioral|Wait list comparison group|Wait list comparison group to receive intervention at later point.
16220085|NCT01237821|Drug|BenzaClin|Topical, 1% Clindamycin/5% Benzoyl Peroxide, BID, 12 weeks
16220086|NCT01237821|Drug|Effaclar|Topical, Bid, 12 weeks
16220087|NCT01237808|Drug|Cytarabine|in all treatment cycles: Cytarabine 20 mg/day, s.c., bid, days 1-7; (total dose 280 mg).
16220088|NCT01237808|Drug|Etoposide|first treatment cycle Etoposide 50 mg/m²/day, continuously i.v., days 1-3; (total dose 150 mg/m2) treatment cycles 2 to 6 Etoposide 100 mg/day, p.o. or i.v. (over 1 hour), days 1-3; (total dose 300 mg).
16220089|NCT01237808|Drug|All-trans retinoic acid (ATRA)|in all treatment cycles: ATRA 45 mg/m²/day p.o., days 8-10, ATRA 15 mg/m²/day p.o., days 11-28, with or shortly after meals distributed on 3 doses per day.
16220090|NCT01237795|Other|Dentifrice|Dentifrices (4 formulations) used as auxiliary agents for brushing complete dentures.
16220091|NCT01237782|Drug|Denture soaking solution|Immersion of complete dentures in 200ml of a denture soaking solution for 20 minutes. Propolis solution: Spa Dent (Nissin Dental Products Inc., Kyoto, Japan).
16220092|NCT01237782|Drug|Saline solution|Immersion of complete dentures in 200ml of a placebo denture soaking solution for 20 minutes.
16220093|NCT01237769|Drug|Vitamin D3|2200 IU/day
16220094|NCT01237769|Behavioral|Lifestyle advice|Diet and exercise
16220095|NCT01237756|Device|measurement of left and right lung ventilation|Patients are ventilated after endotracheal tube placement and left and right lung ventilation if determined using electrical impedance tomography
16220096|NCT01237743|Device|Transcatheter aortic valve implantation.|Transcatheter aortic valve implantation,femoral access.
16220097|NCT01237730|Drug|cefuroxime|Use the cefuroxime as prophylaxis.
16220098|NCT01237730|Drug|Tailored antibiotic|Select the prophylactic antibiotics according to the patients oropharyngeal microorganism.
16220099|NCT01237704|Behavioral|Traditional rehabilitation (TR)|TR rehabilitation will be scheduled three 45-minute sessions per week for 4 weeks with a total of 12 sessions that include Mendelsohn manoeuvre, Shaker's exercise, Effortful swallow and Masako manoeuvre.
16220100|NCT01237704|Behavioral|Transcutaneous electrical stimulation (ES)|Subjects will receive three 45-minute sessions per week for 4 weeks with a total of 12 sessions.
16220101|NCT01237691|Behavioral|HOPE supervision|HOPE entails a warning session (Orientation Hearing) where the rules of parole are laid out and parolees are told that any violation of stated parole conditions will be sanctioned with a brief jail term (typically a few days in jail). HOPE includes regular random drug testing.
16220102|NCT01237691|Behavioral|Parole-as-usual|Parolees are supervised under standard parole supervision practice in California.
16220103|NCT01237678|Drug|IMGN901|Phase 2 regimen is IMGN901, Carboplatin, and Etoposide. IMGN901 to be given on days 1 and 8 every 21 days.
16220104|NCT01237678|Drug|Carboplatin and Etoposide|Patients assigned to Arm 2 were to receive carboplatin at the same AUC as utilized in Arm 1
16220105|NCT01237665|Drug|IXO regimen|"IXO regimen is administered as following: irinotecan 160 mg/m2 i.v. (over 60-90 minutes) with oxaliplatin 100 mg/m2 i.v. (over 120 minutes) on day 1, followed by capecitabine 950 mg/m2 PO, b.i.d. on days 2-15, every 3 weeks.
~Each cycle of IXO lasts 21 days, with the subsequent cycle to start on day 22."
16220106|NCT01237639|Other|Red blood cell Transfusion|Transfusion of Red blood cells to based on daily complete blood count
16220107|NCT01237613|Device|Artelon|Artelon Tissue Reinforcement
16220108|NCT01237600|Procedure|Cultivated limbal transplantation|Cultivated corneal epithelial stem cell transplantation. Autograft, Living related allograft, and Cadaveric allograft
16220109|NCT01237587|Drug|Duloxetine|Administered orally
16220110|NCT01237587|Drug|Placebo|Administered orally
16220111|NCT01237574|Other|Intervention according to the standard of care.|Every 6 months, patients will have clinical, biological and morphological evaluation according to the standard of care.
16220112|NCT01237561|Other|provider support tools plus spirometer|Patient Activation Tool, Provider Web-based decision support tool, academic detailing
16220113|NCT01237548|Other|Smoking Narghile for 30 min|No Other intervention will be used
16220114|NCT01237535|Drug|Luteal support with progesterone only|Luteal support with progesterone only (they will received vaginal P gel (Crinone 8% vaginal gel; Serono, Israel).Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived.If no pregnancy will be achieved patients will undergo 3 treatment cycles preferably in the same treatment group.
16220115|NCT01237535|Drug|Luteal support with estrogen + progesterone|Luteal support with estrogen + progesterone [(Crinone 8% vaginal gel; Serono, Israel) and Estrofem 4mg].Luteal support will begin after insemination and will be continued through the 12th week of gestation if the patient conceived.If no pregnancy will be achieved patients will undergo 3 treatment cycles preferably in the same treatment group.
16220116|NCT01237535|Procedure|Insemination without luteal support|Routine insemination procedure without luteal support
16220117|NCT01237522|Drug|Metformin|A single dose study with one tablet of metformin 500 mg, time frame 24 hours
16220118|NCT01237509|Device|Hypo device|
16220120|NCT01237483|Drug|Erbitux|To begin 7 days before radiotherapy, loading dose 400 mg / m² in the first week then 250 mg / m² weekly for the duration of radiotherapy (for a total of 7 doses including the loading dose)
16220121|NCT01237470|Procedure|Desarda technique|no mesh technique with undetached strip of external oblique aponeurosis placed at the floor of inguinal canal
16220122|NCT01237470|Procedure|Lichtenstein technique|hernioplasty with the usage of plain polypropylene mesh
16220123|NCT01237457|Drug|177Lu-DOTATATE|Patients will receive 200mCi dose of 177Lu Dotatate
16220124|NCT01237444|Drug|lopinavir/ritonavir plus one nucleoside|"ARM 1:
~Lopinavir/ritonavir 200mg/50mg 2 tabs bid plus 3TC 150mg x1 tab bid"
16220125|NCT01237444|Drug|lopinavir /ritonavir plus two nucleosides|"ARM 2:
~3TC 150mg x1 tab bid or FTC 200mg 1 capsule qd plus Lopinavir/ritonavir 200mg/50mg 2 tabs BID plus a second NRTI, selected at investigator's discretion, based on baseline genotype."
16220126|NCT01237431|Dietary Supplement|500ml water intake|subjects have to ingest 500ml water within 5 minutes after resting 30 minutes in supine position
16220127|NCT01237405|Drug|99mTc-EC20|Study participants underwent a one-time evaluation by FolateScan which entailed a single intravenous injection of 99mTc-EC20 (total volume of 1.0 to 2.0 ml administered over a period of 30 seconds with radioactive dose between 20 and 25 mCi). A total of three imaging scans were acquired: an early phase (at ~1 minute) SPECT/CT of both knees; a late phase (at ~60 minutes) SPECT/CT image of both knees; and a late phase (at ~80 minutes) planar image of the whole body was performed (anterior-posterior, and postero-anterior).
16220128|NCT01237392|Device|Contact ultrasonic debridement device|Cavitational ultrasound wound debridement device
16220129|NCT01237366|Behavioral|Resilient Affective Processing Therapy (RAPT)|Participants will be asked to complete 7 intervention sessions which include: 1) expressive writing exercises that focus on exploring thoughts and feelings surrounding a difficult life experience; and 2) stress management skills training to assist participants with managing any acute increases in distress that arise following the writing experience.
16220130|NCT01237353|Dietary Supplement|betaine hydrochloride|betaine hydrochloride 1500mg po x 1 on day 5
16220131|NCT01237353|Drug|Rabeprazole|rabeprazole po daily x 5 days
16220132|NCT01237340|Drug|Saizen®|Single dose of Saizen® (recombinant human growth hormone, r-hGH) solution for injection will be administered subcutaneously for 26 weeks. Dosage regimen will be in accordance with marketed formulation of Saizen® (freeze-dried formulation), based on locally approved product labeling.
16220133|NCT01237327|Drug|Megestrol acetate|Megestrol Acetate 160 mg oral tablets Qd
16220134|NCT01237327|Drug|exemestane (Aromasin)|exemestane (Aromasin) 25 mg oral tablets Qd
16220135|NCT01237301|Device|CGM Group|Using CGM unblinded for 16 weeks versus fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes.
16220136|NCT01237301|Device|SMBG Group|Fingersticks 4 to 7 times a day to evaluate which is more beneficial in type 2 diabetes. Used CGM blinded once every four weeks.
16220137|NCT01237288|Drug|Z-521|
16220138|NCT01237275|Drug|SSRI treated group|characterize in arm of a study (SSRI treated group)
16220139|NCT01237262|Drug|Adalimumab, etanercept, infliximab|"Adalimumab at a dose of 80 mg at week 0 (Baseline) and successively 40 mg every other week starting from week1 and up to week 15. Adalimumab will be administered as subcutaneous injection.
~Etanercept at a dose of 50 mg every week, as subcutaneous injection. Infliximab at a dose of 5 mg/kg at week 0 (Baseline), then at week 2 and every 8 weeks."
16220140|NCT01237249|Drug|Melphalan|
16220141|NCT01237249|Drug|Prednisone|
16220142|NCT01237249|Drug|Velcade|
16220143|NCT01237249|Drug|Revlimid|
16220144|NCT01237249|Drug|Dexamethasone|
16220145|NCT01237236|Drug|LEE011|
16220146|NCT01237223|Drug|Aliskiren/Amlodipine 150/2.5 mg|Aliskiren/amlodipine 150/2.5 mg tablet
16220147|NCT01237223|Drug|Aliskiren/amlodipine 150/5 mg|Aliskiren/amlodipine 150/5 mg tablet
16220148|NCT01237223|Drug|Aliskiren 150 mg|Aliskiren 150 mg tablet
16220149|NCT01237223|Drug|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule
16220150|NCT01237223|Drug|Placebo of Aliskiren|Aliskiren placebo tablet
16220151|NCT01237223|Drug|Placebo of Amlodipine|Amlodipine placebo capsule
16220152|NCT01237223|Drug|Placebo of Aliskiren/amlodipine 150/2.5 mg|Aliskiren/amlodipine 150/2.5 mg placebo tablet
16220153|NCT01237223|Drug|Placebo of Aliskiren/amlodipine 150/5 mg|Aliskiren/amlodipine 150/5 mg placebo tablet
16220154|NCT01237197|Drug|Exenatide|Exenatide 5 micrograms (mcg) twice per day (BID) for one month; up-titrated to 10 mcg twice per day for remainder of study.
16220155|NCT01237197|Drug|Placebo|Participants were randomized to a placebo injection for the first three months, then given open-label Exenatide for the remaining three months (Initiated at 5 mcg, twice per day, delivered by subcutaneous injection. After 1 month, exenatide was uptitrated to 10 mcg, twice per day for the remaining 2 months of the drug treatment phase).
16220156|NCT01237171|Radiation|Cesium-131 Brachytherapy Seed|85 Gray Dose
16220157|NCT01237119|Drug|Liraglutide|1.8 mg once daily, subcutaneous injection
16220158|NCT01237119|Other|Liraglutide-placebo|1.8 mg once-daily, subcutaneous injection
16220159|NCT01237106|Other|IVM|all patients in this pilot study will undergo IVM. IVM involves immature eggs being retrieved and matured in the laboratory.After maturation they are fertilized like is done in a typical IVF cycle.
16220160|NCT01237093|Other|1. Meat, no fish or soda|weight maintaining diet with meat but no fish or soda
16220161|NCT01237093|Other|2. Meat and soda, no fish|weight maintaining diet with meat and soda but no fish
16220162|NCT01237093|Other|3. Meat and fish, no soda|weight maintaining diet with meat and fish but no soda
16220163|NCT01237093|Other|4. Meat and fish and soda|weight maintaining diet with meat, fish and soda
16220164|NCT01237093|Other|5. Fish, no meat or soda|weight maintaining diet with fish but no meat or soda
16220165|NCT01237093|Other|6. Fish and soda, no meat|weight maintaining diet with fish and soda but no meat
16220166|NCT01237093|Other|7. No meat, fish or soda|weight maintaining diet with no meat, no fish, and no soda (vegetarian)
16220167|NCT01237093|Other|8. Soda, no meat or fish|weight maintaining diet with soda but no meat or fish (vegetarian + soda)
16220168|NCT01237080|Device|GlideScope|The GlideScope is an anatomically shaped, rigid, fibreoptic videolaryngoscope.
16220169|NCT01237080|Device|Fastrach|The Fastrach is an intubation laryngeal mask.
16220170|NCT01237067|Drug|Carboplatin|A phase I 3 + 3 safety run-in will optimize tablet olaparib dose (d1-7) in combination with carboplatin on day 1. The carboplatin dose through the randomized portion of the trial will be AUC4. Subsequent accrual will randomize patients to one of 2 schedules on cycle 1 with the other schedule on cycle 2. A: olaparib d1-7 > carbo d8; B: carbo d1 > olaparib d2-8. Cycle 3-8 will be schedule B. After 8 cycles of carboplatin, olaparib will be administered alone on a daily basis.
16220171|NCT01237067|Drug|Olaparib|A phase I 3 + 3 safety run-in will optimize tablet olaparib dose (d1-7) in combination with carboplatin on day 1. The carboplatin dose through the randomized portion of the trial will be AUC4. Subsequent accrual will randomize patients to one of 2 schedules on cycle 1 with the other schedule on cycle 2. A: olaparib d1-7 > carbo d8; B: carbo d1 > olaparib d2-8. Cycle 3-8 will be schedule B. After 8 cycles of carboplatin, olaparib will be administered alone on a daily basis.
16220172|NCT01237054|Drug|18-NaF PET|The patient will receive 5mCi of F-18 NaF IV (intravenous) bolus, followed by a ~20 ml saline (sodium chloride IV infusion 0.9% w/v) flush over a period of ~20 seconds. Serial dynamic imaging (2 minutes/bed position) will be obtained over a 1-hour period. The patient will be permitted an imaging break until a static PET/CT is performed beginning at 2-hours post F-18 NaF injection.
16220173|NCT01237054|Other|DCE-MRI|An FDA (Food and Drug Administration) approved gadolinium chelate (e.g. Magnevist, Berlex Laboratories, NJ, USA) will be administered intravenously at 3 cc/sec using an automated pump injector (Medrad, Pittsburgh, PA, USA).
16220174|NCT01237054|Drug|18-FDG PET/CT|The 18F-FDG injection procedure will be injected and be followed by a ~20 ml saline (sodium chloride IV infusion 0.9% w/v) flush over a period of ~20 seconds. The injection site will be evaluated pre- and post administration for any reaction (e.g. bleeding, hematoma, redness, or infection). Whole body (vertex to toes) static PET/CT imaging will be performed beginning at 1-hour, and again at 2-hours post injection.
16220175|NCT01237041|Drug|Niacin First|Niacin 500 mg po four times on one of the inpatient days, then placebo on another inpatient day
16220176|NCT01237041|Drug|Placebo First|Placebo po four times on one of the inpatient days, then Niacin 500 mg po four times on another inpatient day
16220177|NCT01237041|Drug|Dose-Establishing Study 1 Niacin 250mg|Niacin 250 mg po three times at 2 hour intervals on an inpatient day
16220178|NCT01237041|Drug|Dose-Establishing Study 1 Niacin 500mg|Niacin 500 mg po three times at 2 hour intervals on an inpatient day
16220179|NCT01237041|Drug|Dose-Establishing Study 2 Niacin 500mg|Open-Label Niacin 500mg four times at 1 hour intervals on an inpatient day
16220180|NCT01237028|Drug|Calcitriol|Calcitriol(1,25-dihydroxycholecalciferol, vitamin D3 analog)0.25 μg per day
16220181|NCT01237015|Device|Infant Flow nasal CPAP|Infant Flow nasal CPAP 5 cm H2O
16220182|NCT01236989|Procedure|anatomical liver resection|anatomical liver resection by means of IOUS-finger compression
16220183|NCT01236989|Procedure|Non-anatomical liver resection|non-anatomical liver resection
16220184|NCT01236976|Device|Therastride Treadmill System|This device supports spinal cord injured patients to stand (suspended in a harness by an overhead pulley) on the specially designed treadmill for locomotor training. It is registered with the FDA (Regulation Number 890.5380).
16220185|NCT01236976|Device|FES-assisted cycling|This intervention will be provided using a RT300 cycle (Restorative Therapies, Baltimore MD).
16220186|NCT01236976|Other|Trunk and upper and lower limb exercises|This intervention will comprise assisted and/or resisted movements aimed at facilitating and strengthening voluntary muscle activity and improving movement quality.
16220187|NCT01236976|Other|Upper body strength and fitness program|This intervention is a circuit-based exercise program incorporating resistance and cardiovascular training.
16220188|NCT01236963|Drug|Essential oils mouthrinse|Commercial mouthrinse with manufacturer's use indications
16220189|NCT01236963|Device|Dental Floss|
16220190|NCT01236950|Drug|Essential oils mouthrinse|Commercial mouthrinse with manufacturer's use indication
16220191|NCT01236950|Drug|Delmopinol mouthrinse|Commercial mouthrinse with manufacturer's use indication
16220192|NCT01236937|Device|Bellows-based breath hold device|"Bellows-Based breath hold monitoring system:
~The bellows-based breath hold system (IBC, Mayo Clinic Medical Devices, USA) contains of 2 elements; one belt which is strapped around the thorax of the patient and a voltage controlled light unit with 8 lights. Belt stretch from respiratory motion is converted into voltage readings and displayed on the light unit giving biofeedback as different lights are activated depending on the dept of the respiration. Patients are instructed to keep respiration constant at a certain dept during the second the guide needle is inserted by controlling their breath with the help of the light unit. The patient is given a brief introduction to the system as to how the lights get turned on and off due to respiration motion before the biopsy is preformed."
16220193|NCT01236924|Other|Global postural reeducation|
16220194|NCT01236911|Other|Calcium Measurement|after moderate-severe TBI (less as 24 hrs)
16220195|NCT01236898|Drug|NPC-09|NPC-09 tablet NPC-09 contains 50mg or 100mg N-acetylneuraminic acid (anhydride)
16220196|NCT01236885|Other|computer-assisted intervention|Undergo blood glucose management using Glucommander
16220197|NCT01236872|Dietary Supplement|Beetroot juice|250ml once of beetroot juice
16220198|NCT01236872|Dietary Supplement|Water|250ml once of low-nitrate mineral water
16220199|NCT01236859|Drug|Gabapentin|Neurontin®, Pfizer
16220200|NCT01236846|Dietary Supplement|Fortified Yogurt Drink|Daily intake of yogurt drink fortified (500 ml) with 1000IU vitamin D for 12 weeks
16220201|NCT01236846|Dietary Supplement|Plain Yogurt Drink|Daily intake of unfortified yogurt drink(500 ml)for 12 weeks
16220202|NCT01236833|Drug|Lactated Ringer's Solution|2.5 ml per kg every 3 hours, via nasogastric tube, orogastric tube or orally, until the infant reaches 80 ml/kg/day of milk feeding or for a maximum of 14 days
16220203|NCT01236807|Procedure|MR perfusion guidance|Coronary revascularization guided by MR perfusion imaging
16220204|NCT01236807|Procedure|FFR guidance|Coronary revascularization guided by invasive angiography and FFR
16220241|NCT01235923|Drug|three times weekly Epo|Epo 400 units/kg administered subcutaneously three times per week for a total of 4 weeks
16220242|NCT01235923|Drug|weekly Epo|Epo 1,200 units/kg administered subcutaneously once a week for a total of 4 weeks
16220285|NCT01236287|Drug|Voclosporin|Subjects will receive voclosporin capsules, twice daily to maintain a trough level > 20 ng/mL.
16220205|NCT01236794|Behavioral|Lifestyle Education Sessions and Youth Exercise Sessions|The intervention will include a ~1-2 hour weekly education session to address the following constructs: health awareness, healthy eating, physical activity, roles and responsibilities, self-esteem, self-efficacy, diabetes knowledge, communication, and peer / family relationships. In addition to the education classes youth will participate in 3 exercise sessions per week (~1-1.5 hrs) that will consist of individual and group physical activities to include both aerobic and resistance exercises. The exercise intensity will progressively increase over the 12-week intervention. Both the education and activity sessions will be delivered at the Lincoln Family YMCA.
16220206|NCT01236781|Device|Screening Tomosynthesis|Tomosynthesis imaging sets (limited tomosynthesis set and then a sequential read with the low-dose CC view added for the tomosynthesis plus set).
16220207|NCT01236781|Device|Diagnostic Tomosynthesis|Tomosynthesis imaging sets (limited tomosynthesis set and then a sequential read with the low-dose CC view added for the tomosynthesis plus set).
16220208|NCT01236768|Drug|AG200-15|"Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week patch free period."
16220209|NCT01236768|Drug|Levora|One tablet of Levora will be taken each day for a 28 day cycle.
16220210|NCT01236755|Device|single-vision glasses|Daily wear of glasses to correct vision in the first seven months of the study
16220211|NCT01236755|Device|ortho-k lenses|Nightly wear of lenses to correct vision in day time in the second seven months of the study
16220212|NCT01236742|Device|ortho-k lenses|nightly wear of orthokeratology lenses to correct vision
16220213|NCT01236742|Device|single-vision glasses|daily wear of spectacle glasses to correct vision
16220214|NCT01236716|Drug|Albumin paclitaxel plus carboplatin|Patients receive carboplatin AUC=5 q3w and nab-p 135 mg/m2 weekly for 2 weeks (on days 1 and 8 of a 21-day cycle), followed by a week of rest.
16220215|NCT01236716|Drug|Gemcitabine plus carboplatin|Patients receive carboplatin AUC=5 q3w and gemcitabine 1250 mg/m2 weekly for 2 weeks (on days 1 and 8 of a 21-day cycle), followed by a week of rest.
16220216|NCT01236690|Drug|Cinobufacin injection|Cinobufacin by Perfusion of Hepatic Artery Combining the Arterial Embolotherapy
16220217|NCT01236664|Behavioral|Memory training|The Memory at Work program is a 4-hour classroom-based workshop that is led by a professional trainer. The format of the program is experiential, with a heavy focus on discussion, self-discovery, and hands-on use of trained skills. Specific memory compensation techniques are trained. Training consists of an explanation of each technique (i.e., how and when to use it, the science behind the technique) and ample opportunities for hands-on use of the strategies.
16220218|NCT01236664|Behavioral|Control Workshop|The control workshop consists of a 4-hour program that will train techniques for successfully completing Sudoku, word, and logic puzzles. Like the experimental intervention, the control workshop will be engaging and challenging, and will involve a combination of individual and group activities.
16220219|NCT01236651|Drug|Meperidine|administer 100mg meperidine i.v during the 1st stage of labor and calculate the duration of this stage of labor
16220220|NCT01236651|Drug|Drotaverine|administer 40mg drotaverine i.v during the 1st stage of labor and calculate the duration of this stage of labor
16220221|NCT01236638|Drug|Momelotinib|Patients will continue receiving the same doses as assigned during the CCL09101 protocol; up to 400 mg once per day (QD). CYT387 will be administered orally as a single daily dose (at least 20 and no more than 28 hours apart, preferably in a fasted state at least two hours before and one hour after a meal), except for patients on the twice daily (BID) dosing regime (150 mg BID).
16220222|NCT01236599|Other|Polyethylene for thermoregulation in the preterm infant|3 groups with 30 preterm infants (PI) each one: 1) PI under radiant warmer, drying, wrapped in sterile field preheated (traditional care), 2) PI under radiant warmer, wrapped in polyethylene bag after drying, with their naked face and access to umbilical catheters or venous access, and 3) PI under radiant warmer, without drying, wrapped in polyethylene bag, with their naked face and access to umbilical catheters or venous access. Body temperature (BT) and incubator temperature (IT) were measured every 15 minutes from birth until 120 minutes of extra uterine life.
16220223|NCT01236534|Drug|Lubiprostone|24 mcg twice daily for 21 days.
16220224|NCT01236534|Drug|Placebo|matching placebo twice daily for 21 days.
16220225|NCT01236495|Drug|spinal morphine 0.3 mg|spinal morphine 0.3 mg
16220226|NCT01236495|Drug|spinal morphine 0.2 mg|spinal morphine 0.2 mg
16220227|NCT01236456|Drug|Cyclophosphamide|
16220228|NCT01236443|Drug|HPPH|3 mg/m2 IV
16220229|NCT01236404|Drug|Single Subcutaneous Dose (Part A) of PB1023 or Placebo (0.9% NaCl)|
16220230|NCT01236404|Drug|Multiple (Four Weekly) Subcutaneous Injections (Part B) of PB1023 or Placebo (0.9% NaCl)|Once weekly injections for up to four weeks
16220231|NCT01236391|Drug|PCI-32765|560 mg daily
16220232|NCT01236365|Drug|Atorvastatin|10 or 20 mg daily
16220233|NCT01236365|Drug|Atorvastatin Placebo|10 or 20 mg daily
16220234|NCT01236339|Device|TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis|TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis
16220235|NCT01236339|Procedure|LVP|Large Volume Paracentesis
16220236|NCT01236339|Device|TIPS procedure with the GORE® VIATORR® TIPS Endoprosthesis for subjects who failed LVP and crossed over to TIPS per protocol|
16220237|NCT01236144|Drug|Plerixafor|Fixed dose of Plerixafor (240mcg/kg) given by subcutaneous injection on each day of chemotherapy for up to 3 courses (depending on cohort). The three chemotherapy courses will be Daunorubicin/Clofarabine for courses 1&2 and Daunorubicin/Ara-C for course 3. Each course will last 5 days, and Plerixafor will be given for 5 days.
16220238|NCT01236144|Drug|AC220|Each cohort of patients will receive three courses of chemotherapy approximately 4 to 5 weeks apart which will comprise of Daunorubicin/Ara-C/Etoposide in Courses 1&2 and Daunorubicin/Ara-C in Course 3. Two days after the last day of each chemotherapy course, patients will receive AC220 orally for 7, 14 or 21 (depending on cohort) consecutive days. Depending on which cohort the patient enters, they will receive either 60mg, 90mg or 135mg of AC220 daily, with a provision to assess 40mg if necessary.
16220239|NCT01236144|Drug|Ganetespib|Patients will receive 3 treatments of ganetespib on days 1, 8 and 15 of each course where day 1 is the first day of the chemotherapy. The chemotherapy will be DAE/DAE/DA. Three courses of chemotherapy will be given each of which will be associated with 3 administrations of ganetespib.
16220240|NCT01235936|Drug|AKB-6548|Different dose levels
16220243|NCT01235832|Other|Avocado Diet|The avocado diet will be designed to ensure that all subjects incorporate 1 avocado (~136g) per day into a moderate fat diet. Both the Lower-Fat diet and avocado diet will be matched for SFA and dietary cholesterol, but will differ in total fat, primarily MUFA as provided by the avocado. The moderate fat plus avocado diet will provide 34% of calories from total fat, 18% calories from MUFA, and 9% calories from PUFA.
16220244|NCT01235832|Other|Lower-Fat Diet|The Lower-Fat diet will provide ~24% of calories from fat and meet the SFA and cholesterol recommendations of a Step-II diet recommended by the National Heart, Lung, and Blood Association's National Cholesterol Education Program. SFA will provide 7% of calories, and cholesterol will be less than 200mg/day. Vegetables and fruits in the Lower-Fat diet will be selected from foods that are low in antioxidants.
16220245|NCT01235832|Other|Moderate Fat Diet|This diet is designed to be the control diet for the avocado diet and will have an identical fatty acid profile. MUFA-enriched food (fats) will be substituted for avocado. The substitution foods will not contain antioxidant or cholesterol-lowering components similar to those in avocado.
16220246|NCT01235819|Drug|Insulin|Exenatide Sitagliptin
16220247|NCT01235819|Drug|Sitagliptin|Sitagliptin 100 mg per day oral
16220248|NCT01235819|Drug|Exenatide|Exenatide 10 micrograms daily twice
16220249|NCT01235793|Drug|Temozolomide|The DRBEAT regimen will be similar to RBEAM. Rituximab and Carmustine will be given Day -6. Etoposide and Cytarabine will be given on Days -5 to -2. Temozolomide will be given via divided doses over five days starting on Day -5 to Day -1. A dose escalation design, known as EWOC (Escalation with overdose control) will be used to determine the target dose of temozolomide for this study. The starting dose given over five days will begin at 250mg/m2 (cumulative total dose of 1250 mg/m2), as previous data indicates this to be a safe dose. Based on the reported Dose Limiting toxicities from the previous patients, the EWOC statistical modeling will be performed to determine the next dose level.
16220250|NCT01236625|Procedure|Adhesiolysis|Blunt or sharp dissection of adhesive tissue.
16220251|NCT01236612|Drug|Chloroquine prophylaxis|The chloroquine dose used will be 300mg for the first two days, followed by 300mg per week, for 13 weeks.
16220252|NCT01236612|Biological|Immunization|Groups 1 and 2 will be immunized with 3 times 15 bites of Pf infected mosquitoes under chloroquine prophylaxis.
16220253|NCT01236612|Biological|Plasmodium falciparum Bloodstage challenge|Groups 1 and 3 will be challenged by intravenous administration of Plasmodium falciparum infected erythrocytes.
16220254|NCT01236612|Biological|Plasmodium falciparum mosquito challenge|Groups 2 and 4 will be challenged by the bites of 5 Plasmodium falciparum infected mosquitoes.
16220255|NCT01236612|Drug|Malarone treatment|When thick smear positive, of ar day 21 after challenge, all volunteers will be treated with malarone.
16220256|NCT01236586|Drug|RO4929097|
16220257|NCT01236586|Drug|Dexamethasone|
16220258|NCT01236573|Drug|Fludarabine|Fludarabine 25 mg/m^2/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days.
16220259|NCT01236573|Drug|Cyclophosphamide|Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose 5% in water (D5W) over 1 hr.
16220260|NCT01236573|Biological|IL-12 transduced TIL|On day 0 (one to four days after the last dose of fludarabine), cells will be infused intravenously (i.v.) on the Patient Care Unit over 20 to 30 minutes.
16220261|NCT01236560|Biological|Bevacizumab|Given IV
16220262|NCT01236560|Drug|Temozolomide|Given PO
16220263|NCT01236560|Drug|Vorinostat|Given PO
16220270|NCT01236508|Radiation|PET/CT imaging with F-18 fluorodeoxyglucose|Dose of 5 MBq/kg F-18-FDG given to fasting participant. Nuclear whole body imaging starting at 3 hours post-injection. The relation of the PET/CT image results and both the number of covert brain infarcts and the extent of white matter MRI hyperintensity will be investigated.
16220271|NCT01236482|Drug|Oxytocin versus oxytocin-ergometrine|Group 1: Oxytocin 0.1 I.U./kg/hr (plain) Group 2: Oxytocin 0.1 I.U./kg/hr with ergometrine 2 mcg/kg/hr co-administered Infusion rates determined to achieve equipotential doses based on an earlier PKPD study
16220272|NCT01236469|Procedure|Echocardiogram|A prospective follow-up Study Echocardiogram will be performed, as applicable, for those subjects who do not have echo data as of January 1, 2009.
16220273|NCT01236430|Drug|Ezetimibe|Ezetimibe 10mg tablet given orally after an overnight fast (at least 10 hours).
16220274|NCT01236430|Drug|Ezetimibe/atorvastatin 10mg/10mg FDC|Ezetimibe/atorvastatin 10mg/10mg FDC tablet given orally after an overnight fast (at least 10 hours).
16220275|NCT01236430|Drug|Atorvastatin 10mg|Atorvastatin 10mg given orally after an overnight fast (at least 10 hours).
16220276|NCT01236430|Drug|Atorvastatin 80mg|Atorvastatin 80mg tablet given orally after an overnight fast (at least 10 hours).
16220277|NCT01236430|Drug|Ezetimibe/atorvastatin 10mg/80mg FDC|Ezetimibe/atorvastatin 10mg/80mg FDC tablet given orally after an overnight fast (at least 10 hours).
16220278|NCT01236417|Behavioral|Exercising block|Exercising for 8 weeks using an elastic band
16220279|NCT01236378|Drug|Sirolimus|Sirolimus, 1 mg, white, triangular tablets, daily dose, dosages of any of these medications must be stable for at least 2 weeks prior to screening and continue with no change until completion of the last PK sample collection.
16220280|NCT01236352|Drug|BMS-911543|
16220281|NCT01236326|Procedure|Laparoendoscopic single site donor nephrectomy|Patients randomized to this arm will undergo laparoendoscopic single site donor nephrectomy
16220282|NCT01236326|Procedure|Conventional laparoscopic donor nephrectomy|Patients randomized to this arm will undergo conventional laparoscopic donor nephrectomy
16220287|NCT01236248|Behavioral|Prevention|9-session computerized cognitive behavioral program that young girls and their mothers interact with on a weekly basis in the privacy of their home. Girls and their mothers will watch and interact with 10 compact disc (CD) intervention sessions to learn skills to help girls avoid substance use.
16220288|NCT01236222|Behavioral|Cycling to school|Regular cycling to school
16220289|NCT01236209|Other|Webpage|one arm having access to a webpage with information about coping with pain and relaxation exercises
16220290|NCT01236209|Other|Webpage and situation feedback|having access to the same web-page with information about coping with pain and relaxation relaxation and completing 3 diaries and receiving situational feedback for 4 weeks at home through a web enabled mobile phone.
16220291|NCT01236196|Behavioral|Telephone cognitive behavior therapy|Cognitive behavior therapy aimed at teaching pain coping skills was conducted by telephone (12 sessions over a 6-month period).
16220292|NCT01236196|Behavioral|Telephone pain education|Participants received information on the management of chronic pain during 12 telephone sessions conducted over a 6-month period).
16220293|NCT01236131|Other|no intervention|Not Applicable- no intervention
16220294|NCT01236118|Drug|LY2439821|Administered subcutaneously
16220295|NCT01236105|Drug|LY2624803|Administered orally (po), once.
16220296|NCT01236105|Other|Activated Charcoal|Administered po
16220297|NCT01236092|Other|conservative therapy - traction, vibration, exercise|10 weeks of therapy. 3 treatments per week the first 4 weeks and 2 treatments the final 6 weeks.
16220298|NCT01236079|Behavioral|Assisted referral & IVR|includes assistance in enrolling in outpatient cessation services, pharmacy orders for cessation medication, interactive voice recognition follow-up
16220299|NCT01236066|Other|Database analysis|Existing computerised administrative databases from the Australian Institute of Health and Welfare (AIHW) will be reviewed to retrieve data on all-cause gastroenteritis/ rotavirus enteritis and bronchiolitis hospitalisations of children <5 years in all the states using Rotarix from 1998 to 2009. Data from Australian Childhood Immunisation Register (ACIR) post introduction of rotavirus vaccines in the National Immunisation Program (2007 to 2009) will also be used.
16220300|NCT01236053|Drug|Gabapentin prescriptions|The exposure of interest is gabapentin use as defined by prescriptions recorded by the GPRD general practitioner (British National Formulry codes). Data on prescriptions for gabapentin will be extracted for each case and control from entry into the study cohort up to two years prior to the index date (the exposure window). A two year lagged exposure is incorporated to account for latency between cancer onset and GPRD diagnosis, and for protopathic bias (gabapentin prescription for initial pain symptoms of undiagnosed cancer). Gabapentin exposure will be parameterized as follows: (1) Ever versus never exposed; (2) Number of prescriptions; (3) Duration of exposure; and (4) Cumulative dose.
16220301|NCT01236040|Biological|GSK Biologicals' investigational vaccine GSK2590066A|Intramuscular injection, two doses
16220302|NCT01236040|Biological|GSK Biologicals' investigational vaccine GSK2592984A|Intramuscular injection, two doses
16220303|NCT01236040|Biological|GSK Biologicals' investigational vaccine GSK2340274A|Intramuscular injection, two doses
16220304|NCT01236040|Biological|GSK Biologicals' investigational vaccine GSK2340273A|Intramuscular injection, two doses
16220305|NCT01236040|Other|Placebo|Intramuscular injection, two doses
16220306|NCT01236027|Other|no intervention|not applicable-no intervention
16220307|NCT01236014|Drug|Eltrombopag|Eltrombopag & standard of care
16220308|NCT01236014|Drug|Romiplostim|Romiplostim & standard of care
16220309|NCT01236014|Drug|Placebo|Placebo & standard of care
16220310|NCT01236001|Drug|Lacosamide|
16220311|NCT01235988|Drug|Eltrombopag|Eltrombopag 50mg & standard of care
16220312|NCT01235988|Drug|Placebo|Placebo + standard of care
16220313|NCT01235975|Biological|Meningococcal vaccine GSK 134612|Intramuscular injection
16220314|NCT01235975|Biological|MencevaxACWY TM|Subcutaneous injection
16220315|NCT01235962|Drug|pazopanib|Pazopanib monohydrochloride salt was supplied as aqueous, film-coated tablets containing 200 mg of the free base. The 200 mg tablets were oval-shaped and white in color.
16220316|NCT01235962|Drug|placebo|Placebo matching pazopanib was supplied as aqueous, film-coated tablets containing 200 mg of the free base. The 200 mg tablets were oval-shaped and white in color.
16220317|NCT01235962|Drug|pazopanib|Pazopanib 600 mg daily initial dose for 8-12 weeks, dose can be escalated to 800 mg daily based on safety evaluation.
16220318|NCT01235962|Drug|placebo|placebo matching pazopanib daily initial dose for 8-12 weeks, dose can be escalated to 800 mg daily based on safety evaluation.
16220319|NCT01235949|Biological|GSK1024850A (SynflorixTM)|Intramuscular injection, 4 doses
16220320|NCT01235949|Biological|Infanrix hexa|Intramuscular injection, 3 doses
16220321|NCT01235949|Biological|Infanrix-IPV/Hib|Intramuscular injection, 1 dose
16220322|NCT01235949|Drug|Ibuprofen|Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
16220323|NCT01235949|Drug|Paracetamol|Oral administration, 3 doses in the 24 hours following vaccination with an interval of 6-8 hours between doses and with dosage based on the subject's body weight
16220324|NCT01235910|Drug|Aliskiren|Aliskiren 75 mg once daily x 2 weeks, then aliskiren 150 mg once daily x 2 weeks, if blood pressure allows
16220325|NCT01235897|Drug|MK-2206|Different dose levels of MK-2206 will studied, and co-administered with paclitaxel and trastuzumab. MK-2206 will be given orally with a starting dose of 135 mg weekly
16220326|NCT01235897|Drug|Paclitaxel|80 mg/m2 weekly - paclitaxel
16220327|NCT01235897|Drug|Trastuzumab|2 mg/kg weekly after a 1-time loading dose of 4 mg/kg - trastuzumab
16220328|NCT01235884|Dietary Supplement|Lactobacillus reuteri|1000000000 CFU per day (5 drops) for 28 days
16220329|NCT01235884|Dietary Supplement|Placebo|5 drops daily for 28 days
16220330|NCT01235871|Drug|SB1578|JAK2 Inhibitor
16220331|NCT01235871|Drug|Placebo|Control arm
16220332|NCT01235858|Procedure|wearing of sterile gowns|Anesthesiologists wearing sterile gown for epidural insertion
16220333|NCT01235858|Procedure|No gown|Anesthesiologists not wearing sterile gown for epidural insertion
16220374|NCT01235507|Drug|tocilizumab [RoActemra/Actemra]|8 m/kg (maximum 800 mg) intravenously every 4 weeks for a total of 6 infusions
16220334|NCT01235845|Biological|Biological: DC activated CIK combined with DC|"Dendritic cells pulsed With tumor lysate were injected back into the patient intradermally close to a lymph node, DC vaccinations will be given every week for a total of four vaccinations.
~DC activated CIK combined with IL-2 were injected intratumorally via an Ommaya reservoir every week for a total of two vaccinations."
16220335|NCT01235806|Radiation|MRI|MRI of the scaphoid bone fracture suspicion
16220336|NCT01235767|Other|Food|Animal-source food (ASF) supplement rich in iron, zinc, vitamin A, and vitamin B12 taken week-days at mid-morning separate from other food. Length of intervention is either from pre-pregnancy (time of registration to marry) to term or from 16 weeks gestation to term.
16220337|NCT01235754|Drug|transdermal testosterone gel 1%|300 mcg once daily transdermal testosterone gel 1%
16220338|NCT01235754|Drug|placebo gel|once daily transdermal placebo gel
16220339|NCT01235741|Drug|Pramlintide+Metreleptin|Group A: Subcutaneous Injection once a day (QD): Pramlintide 360 mcg+Metreleptin 5.0 mg for 1 week followed by Pramlintide 360 mcg+Metreleptin 5.0 mg twice a day (BID) for 15 weeks.
16220340|NCT01235741|Drug|Placebo|Group B: Subcutaneous Injection-twice a day (BID): Placebo equivalent volumes to active doses.
16220341|NCT01235728|Drug|MK-0873 2% Cream|Approximately 3 to 5 mg of MK-0873 2% cream per cm^2 of body area in 2 divided applications per day for 28 days. The maximum area for one treatment will be approximately 5% of body surface area.
16220342|NCT01235728|Drug|MK-0873 vehicle (placebo) Cream|Approximately 3 to 5 mg matching placebo to MK-0873 2% cream per cm^2 of body area in 2 divided applications per day for 28 days. The maximum area for one treatment will be approximately 5% of body surface area.
16220343|NCT01235728|Drug|Calcitriol Cream|Approximately 3 to 5 mg of Calcitriol 0.0003% (3 µg/g) per cm^2 of body area once daily for 28 days. The maximum area for one treatment will be approximately 5% of body surface area
16220344|NCT01235715|Drug|Evicel fibrin sealant|Used for hemostasis to control bleeding. It has been shown to stop bleeding in 2 minutes or less. It is a combination of a biologic activated component containing human fibrinogen and topical thrombin functioning on wet, actively bleeding tissue.
16220345|NCT01235702|Behavioral|12-week lifestyle modification|
16220346|NCT01235689|Biological|Adalimumab|If adalimumab was initiated, it was administered subcutaneously as a 160 mg induction dose the first week, followed by 80 mg 2 weeks later, followed by 40 mg every other week as a maintenance dose. The dose of adalimumab was increased from 40 mg eow to 40 mg every week in participants with an inadequate response and de-escalated to 40 mg eow in participants who met success criteria.
16220347|NCT01235689|Drug|Prednisone|The suggested regimen for participants initiating prednisone consisted of a maximum dose of prednisone 40 mg/day for 2 weeks, followed by a fixed taper for 6 weeks.
16220348|NCT01235689|Drug|Azathioprine|Participants with normal thiopurine methyltransferase (TPMT) enzyme activity could receive oral azathioprine 2.5 mg/kg/day. In participants with intermediate TPMT enzyme activity azathioprine was initiated at a dose of 1.25 mg/kg/day. The dose of azathioprine was adjusted according to abnormalities of white blood cell (WBC) count, platelet count, liver function tests (LFTs; i.e. alanine transaminase [ALT], aspartate transaminase [AST], alkaline phosphatase), lipase, blood urea nitrogen (BUN), and serum creatinine.
16220349|NCT01235676|Behavioral|diet|calorie restriction to reduce weight gain
16220350|NCT01235676|Behavioral|Exercise|Exercise to reduce weight gain
16220351|NCT01235663|Behavioral|advisory support|regular advisory support to the prolong breast-feeding period
16220352|NCT01235637|Drug|Alfentanil|"dosage form: injectable drug, opioid analgesic morphine, intravenous drug.
~Dosage: 10μg/Kg, dilution: 1 ml = volume equivalent to 66μg or 10μg/kg = 1.43μg/kg fentanyl.
~Frequency and duration: 2 bolus injection before 2 tracheal suctions at 0 and 4 hours respectively."
16220353|NCT01235637|Drug|Sufentanil|"dosage form: injectable drug, opioid analgesic morphine, intravenous drug.
~Dosage: intravenous drug to 0,15 µg/Kg : Blisters of 10 ml, box of 20. MERCK
~Frequency and duration: 2 bolus injection before 2 tracheal suctions at 0 and 4 hours respectively."
16220354|NCT01235624|Genetic|genetic analysis|
16220355|NCT01235598|Other|Placebo|Placebo provided for the first subcutaneous injection in single-use vials at Week 0 (2 vials required), then Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4 and 6, followed by Certolizumab Pegol (CZP) 200 mg every 2 weeks from Week 8 to Week 40
16220356|NCT01235598|Biological|Certolizumab Pegol (CZP) 200 mg|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
16220357|NCT01235598|Biological|Certolizumab Pegol (CZP) 400 mg|Placebo, saline solution for subcutaneous injection at Week 0 followed by Certolizumab Pegol (CZP) 400 mg at Weeks 2, 4, and 6, then Certolizumab Pegol (CZP) 200 mg 2-weekly from Week 8 to Week 40
16220358|NCT01235585|Drug|Placebo|Oral doses, once a day for 52 weeks
16220359|NCT01235585|Drug|bitopertin [RO4917838]|Oral dose level 1, once a day for 52 weeks
16220360|NCT01235585|Drug|bitopertin [RO4917838]|Oral dose level 2, once a day for 52 weeks
16220361|NCT01235572|Procedure|standard follow-up care|Undergo early discharge and standard outpatient care
16220362|NCT01235572|Other|medical chart review|Undergo early discharge and standard outpatient care
16220363|NCT01235572|Procedure|quality-of-life assessment|Ancillary studies
16220364|NCT01235559|Drug|Placebo|Oral doses, once a day for 52 weeks
16220365|NCT01235559|Drug|bitopertin [RO4917838] level 1|Oral dose level 1, once a day for 52 weeks
16220366|NCT01235559|Drug|bitopertin [RO4917838] level 2|Oral dose level 2, once a day for 52 weeks
16220367|NCT01235546|Drug|Azithromycin and standard of care|500 mg in 250 cc normal saline 1 time dose plus standard of care (cephazolin or clindamycin)
16220368|NCT01235546|Drug|Placebo and standard of care|250 cc normal saline, plus standard of care (cephazolin or clindamycin)
16220369|NCT01235533|Dietary Supplement|N-3 polyunsaturated fatty acids|Three capsules per day. Each capsule included 600mg eicosapentanoic acid (20:5n-3), 400 mg of docosahexanoic acid (22:6n-3), tertiary-butylhydroquinone 0.2 mg/g and tocopherols 2 mg/g.
16220370|NCT01235520|Drug|Placebo|Oral doses, once a day for 52 weeks
16220371|NCT01235520|Drug|RO4917838|Oral dose level 1, once a day for 52 weeks
16220372|NCT01235520|Drug|RO4917838|Oral dose level 2, once a day for 52 weeks
16220373|NCT01235507|Drug|methotrexate|stable dose as prescribed
16220376|NCT01235481|Device|Exercise DVD|Exercise DVD added to usual care during maintenance phase of pulmonary rehabilitation
16220377|NCT01235481|Behavioral|Usual Care|Usual care during maintenance phase post pulmonary rehabilitation
16220378|NCT01235468|Biological|ex vivo expansion|ex-vivo expansion of cord blood for transplantation
16220379|NCT01235455|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|250 µg, sub-cutaneously, on alternate days
16220380|NCT01235442|Drug|1=Etanercept|50 mg SC bi-weekly for 12 weeks followed by 50 mg SC weekly for 12 weeks.
16220381|NCT01235442|Drug|2=Clobetasol propionate foam|0.05% clobetasol propionate foam applied topically twice daily during two up-to-2 week courses
16220382|NCT01235429|Behavioral|Partners in Care|Participants will be offered 12 group diabetes self-management educational lessons delivered by trained community health workers.
16220383|NCT01235429|Behavioral|Partners in Care|Diabetes self-management education
16220384|NCT01235416|Drug|AMG 706|In each of these 3 planned treatment cohorts, approximately 6 evaluable subjects will be treated with gemcitabine (1000-mg/m2 intravenously over 30 minutes, once weekly starting on day 1, week 1 of cycle 1) and erlotinib (100 mg orally once daily starting on day 1, week 1 of cycle 1)
16220385|NCT01235403|Drug|Lacosamide|"Lacosamide : 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks.
~Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day.
~Taper phase if needed: 3 to 4 weeks"
16220386|NCT01235390|Dietary Supplement|Walnuts|The consumption of assigned walnuts once a day during 4 weeks
16220387|NCT01235377|Other|Favor one of two thiazides for new prescriptions & attempt target dose|Providers will be randomized to either Favor Chlorthalidone or Favor Hydrochlorothiazide for patients who are to be newly prescribed a thiazide for hypertension, whether the thiazide is 1st line or add-on therapy. Providers will have agreed to adhere to their assignment for patients for whom there is equipoise, but they are free to deviate if medically indicated for individual patients. There is no requirement to maintain the initial thiazide therapy; it is expected that the regimen may require adjustment over time. The cluster assignment is simply to favor a particular thiazide on initiation of thiazide therapy and attempt to reach the target dose.
16220388|NCT01235364|Device|Foley catheter|The Foley catheter was placed with the digital method
16220389|NCT01235364|Device|Foley catheter|The Foley catheter was placed with a speculum
16220390|NCT01235351|Drug|Clopidogrel|Clopidogrel 75 mg daily, 150 mg daily, 225 mg daily, and 300 mg daily based on genotype
16220391|NCT01235351|Drug|Clopidogrel|Clopidogrel 75 mg daily, 150 mg daily
16220392|NCT01235338|Drug|LDX + Venlafaxine XR|"Day 1-5 LDX 30mg
~Day 6-10 LDX 50mg
~Day 11-15 LDX 70mg
~Day 16-20 LDX 70mg and Venlafaxine XR 75mg daily
~Day 21-25 LDX 70mg and Venlafaxine XR 150mg daily
~Day 26-30 LDX 70mg and Venlafaxine XR 225mg daily
~Day 31-34 Venlafaxine XR 150mg daily
~Day 35-38 Venlafaxine XR 75mg daily."
16220393|NCT01235338|Drug|Venlafaxine XR + LDX|"Day 1-5 Venlafaxine XR 75mg
~Day 6-10 Venlafaxine XR 150mg
~Day 11-15 Venlafaxine XR 225mg
~Day 16-20 Venlafaxine XR 225mg and LDX 30mg daily
~Day 21-25 Venlafaxine XR and LDX 50mg daily
~Day 26-30 Venlafaxine XR 225mg and LDX 70mg daily
~Day 31-34 Venlafaxine XR 150mg
~Day 35-38 Venlafaxine XR 75mg."
16220394|NCT01235325|Dietary Supplement|phylloquinone (vitamin K1)|1000 mcg phylloquinone (vitamin K1) once daily for 12 months
16220395|NCT01235325|Dietary Supplement|placebo|placebo oil capsule
16220396|NCT01235286|Procedure|remote ischemic preconditioning|"A standardized location for microcirculatory assessment was determined on the left leg of each participant between the proximal and distal third of a drawn line between the anterior superior iliac spine and the lateral aspect of the Patella.
~The healthy subjects had to rest before starting data assessment in a horizontal position for 15 minutes. The probe was taped on the left upper leg in a standardized manner after localizing the measuring point. A blood pressure cuff was applied on the contralateral upper arm. Baseline data was assessed over 5 minutes before starting remote ischemia. Three circles of a five minute ischemia were applied at the contralateral right upper arm at suprasystolic levels. Parameters of microcirculation were assessed continuously over time. Microcirculation during the reperfusion phase was ascertained over 10 minutes after first and second remote ischemia and 15 minutes after the third remote ischemia."
16220397|NCT01235273|Drug|Growth Hormone|growth hormone administration
16220398|NCT01235273|Other|Placebo|standard placebo
16220399|NCT01235260|Other|Becaplermin nonusers|A cohort of becaplermin nonusers (ie, patients who are not treated with becaplermin but are similar in characteristics to patients in the becaplermin user cohort)
16220400|NCT01235260|Drug|Becaplermin users|A cohort of becaplermin users (ie, patients with diabetes treated with becaplermin)
16220401|NCT01235247|Behavioral|reminders vs. no reminders|Intervention providers will receive clinical reminders as part of patient care, and control group providers will not receive the reminders
16220402|NCT01235234|Drug|CF101|orally q12h
16220403|NCT01235221|Drug|BIIB041 (Fampridine-SR)|10 mg twice a day (BID) sustained-release (SR) tablets by mouth for up to 27 months (in addition to treatment in previous studies) or until the product is commercially available, whichever comes first. Doses of study treatment must be spaced at least 12 hours apart.
16220404|NCT01235208|Other|"The Dr. Fedon Lindbergs Vektcoach Treatment"|Diet and lifestyle treatment
16220405|NCT01235195|Drug|sertraline hydrochloride|50 mg capsule, single-dose
16220406|NCT01235195|Drug|sertraline hydrochloride|50 mg tablet, single-dose
16220407|NCT01235169|Device|Proximal Femoral Nail Antirotation(PFNA) with cement augmentation|
16220408|NCT01235143|Drug|Desflurane|Desflurane (not more than 1 MAC) for maintenance of anesthesia in urologic surgery
16220409|NCT01235143|Drug|Sevoflurane|Sevoflurane (not more than 1 MAC) for maintenance of anesthesia in urologic surgery
16220410|NCT01235130|Drug|OMEGA-3|600mg, 2 caps, twice a day
16220411|NCT01235130|Drug|Placebo soybean oil|600mg, 2caps twice a day
16220412|NCT01235117|Drug|azacitidine|
16220413|NCT01235117|Other|laboratory biomarker analysis|
16220414|NCT01235104|Procedure|Total nephrectomy|Total nephrectomy
16220452|NCT01234857|Drug|exemestane|Exemestane 25 mg daily (QD). Treatment will continue until disease progression. Patients may cross-over to the combination therapy after disease progression at the discretion of the investigator with Sponsor approval.
16220415|NCT01235091|Behavioral|NIDA Cooperative Agreement Standard Intervention plus HIV/STD testing|At the end of Baseline Session I, HIV pre-test counseling, per the NIDA Cooperative Agreement, was delivered, along with education about STD prevention, and biological samples were collected to test for HIV, Hepatitis C, syphilis, chlamydia and gonorrhea. At Baseline Session II, HIV post-test counseling was conducted and women were given their random group assignment.
16220416|NCT01235091|Behavioral|Standard Intervention plus Well-Woman Exam|At the end of Baseline Session I, HIV pre-test counseling, per the NIDA Cooperative Agreement, was delivered, along with education about STD prevention, and biological samples were collected to test for HIV, Hepatitis C, syphilis, chlamydia and gonorrhea. At Baseline Session II, HIV post-test counseling was conducted and women were given their random group assignment. This group was assigned to additionally receive a well-woman examination within seven days.
16220417|NCT01235091|Behavioral|Standard Intervention plus Well-Woman Exam and Peer-Delivered Intervention|At the end of Baseline Session I, HIV pre-test counseling, per the NIDA Cooperative Agreement, was delivered, along with education about STD prevention, and biological samples were collected to test for HIV, Hepatitis C, syphilis, chlamydia and gonorrhea. At Baseline Session II, HIV post-test counseling was conducted and women were given their random group assignment. This group was assigned to receive a well-woman exam within seven days along with four two-hour peer-delivered educational sessions, covering health and nutrition, stress and coping, substance abuse, and HIV/AIDS.
16220418|NCT01235078|Device|EZ-IO|powered intraosseous vascular access system
16220419|NCT01235065|Device|type of laryngoscope|Patients who require emergency rapid sequence intubation are randomized to intubation with either the direct laryngoscope or the video laryngoscope
16220420|NCT01235052|Radiation|Positon Emission Tomography using 18F-FMISO|We will introduce a pretherapy [18F]-FMISO PET-CT in the treatment planning of patients suffering of head and neck cancer and eligible to a radical treatment with curative intent, consisting of conformational radiotherapy with or without chemotherapy or associated targeted therapy. [18F]-FMISO PET-CT results will not be taken into account for the patients' management. We will test different acquisition protocols and use a wild panel of quantification parameters issued from published studies and originals 'one developed by our team enable to describe [18F]-FMISO uptake. Patients will be followed clinically and para-clinically during two years after the end of the treatment according to the edited recommendations of these tumours type and grade to analyze outcome.
16220421|NCT01235039|Drug|VIAject®25|Two vial presentation for reconstitution and single dose of 12 IU subcutaneous injection and 25 IU/mL
16220422|NCT01235039|Drug|VIAject®7|One vial presentation and single dose of 12 U for subcutaneous injection and 100 IU/mL
16220423|NCT01235039|Drug|Insulin Lispro|One vial presentation and single dose of 12 IU for subcutaneous injection and 100 IU/mL
16220424|NCT01235026|Dietary Supplement|Synbiotic|"5g of the prebiotic Oligofructose + 1 g of the probiotic Bifidobacterium animalis subsp. lactis Bb12 (4x10^10 CFU/g), twice a day, for 6 weeks."
16220425|NCT01235026|Dietary Supplement|Placebo|6g of maltodextrin, twice a day for 6 weeks.
16220426|NCT01235013|Drug|Maraviroc|150 mg of Maraviroc every 12 hours (300 mg daily) orally for 24 weeks
16220427|NCT01235000|Biological|2010-11 trivalent inactivated influenza vaccine|A single age-appropriate dose of 2010-11 trivalent inactivated influenza vaccine
16220428|NCT01234974|Drug|Pasireotide|Given as an intramuscular injection on day 1 every 28 days, 60 mg per dose
16220429|NCT01234974|Drug|Everolimus|given as an oral tablet every day on days 1-28, 10 mg per day
16220430|NCT01234961|Behavioral|Redesigning Daily Occupations|The ReDO is a 16-week group-based programme, comprising three phases. Phase I covers five weeks and has a special focus on occupational self-analysis, while Phase II, also comprising five weeks, is concentrated around goal setting and strategies for accomplishing desired changes in the patterns of everyday activities. During these ten weeks the group meets twice a week and each session lasts for 2½ hrs. Phase III consists of work placement for six weeks, if possible in relation to the woman's ordinary work but otherwise at another relevant work place. During Phase III the group meets three times (weeks two, four and six) in order to monitor the group placement. The groups are led by two licensed occupational therapists specifically trained for the ReDO programme.
16220431|NCT01234961|Other|Care as usual|The CAU group gets follow-ups by an officer at the Social Insurance Office, including contacts with the employer, but the additional support varies largely, from receiving relevant medical care, if any, to physical therapy and to more comprehensive rehabilitation programmes.
16220432|NCT01234935|Drug|dasatinib|Given orally
16220433|NCT01234935|Drug|gemcitabine hydrochloride|Given IV
16220434|NCT01234935|Other|laboratory biomarker analysis|Correlative studies
16220435|NCT01234935|Genetic|mutation analysis|Correlative studies
16220436|NCT01234935|Genetic|nucleic acid sequencing|Correlative studies
16220437|NCT01234935|Other|immunohistochemistry staining method|Correlative studies
16220438|NCT01234922|Drug|lisinopril|Given orally
16220439|NCT01234922|Drug|losartan potassium|Given orally
16220440|NCT01234922|Other|laboratory biomarker analysis|Correlative studies
16220441|NCT01234922|Drug|benazepril hydrochloride|Given orally
16220442|NCT01234922|Drug|ramipril|Given orally
16220443|NCT01234896|Drug|Nicotine Medicated Gum|Dosage Form: Gum; Dosage: 6 mg; Frequency: Once; Duration: 30 minutes
16220444|NCT01234896|Drug|4 mg Nicotine Gum|Dosage Form: Gum; Dosage: 4 mg; Frequency: Once; Duration: 30 minutes
16220445|NCT01234896|Drug|2 mg Nicotine Gum|Dosage Form: Gum; Dosage: 2 mg; Frequency: Once; Duration: 30 minutes
16220446|NCT01234896|Drug|4 mg Nicotine Lozenge|Dosage Form: Lozenge; Dosage: 4 mg; Frequency: Once; Duration: until dissolved
16220447|NCT01234883|Drug|multiple electrolyte solution|IV multiple electrolyte solution dosed as clinically indicated for rehydration
16220448|NCT01234883|Drug|saline|IV solutions dosed as clinically indicated for rehydration
16220449|NCT01234870|Drug|Gadolinium|
16220450|NCT01234870|Drug|Adenosine|
16220451|NCT01234857|Drug|ridaforolimus + dalotuzumab|Ridaforolimus 20 mg once daily (QD) five days a week, with the possibility of escalation to 30 mg once daily (QD) after the first cycle and dalotuzumab intravenous infusion 10 mg/kg once weekly (QW). Treatment will continue until disease progression.
16220501|NCT01234597|Drug|INSULIN GLULISINE (HMR1964)|Pharmaceutical form:Solution for injection Route of administration: Subcutaneous
16220453|NCT01234857|Drug|ridaforolimus|Ridaforolimus 40 mg QD five days a week. Treatment will continue until disease progression. Patients may cross-over to the combination therapy after disease progression at the discretion of the investigator with Sponsor approval. Note: the Sponsor-recommended dose of ridaforolimus when administered as a single agent is 40 mg/day, but when given in combination with dalotuzumab, it is given at 30 mg/day.
16220454|NCT01234857|Drug|dalotuzumab|Dalotuzumab intravenous infusion 10 mg/kg QW. Treatment will continue until disease progression. Patients may cross-over to the combination therapy after disease progression at the discretion of the investigator with Sponsor approval.
16220455|NCT01234844|Behavioral|care of guinea pigs|twice weekly sessions of care with guinea pigs
16220456|NCT01234844|Behavioral|guinea pigs|"twice weekly pet therapy and twice weekly usual  occupational therapy"
16220457|NCT01234831|Device|nucleic acid amplification of nasal swab; nasal swab culture|Nasal swab is performed and analyzed using nucleic acid amplification to determine the presence or absence of MRSA DNA. One nasal swab is performed each day for three consecutive days during hospitalization.
16220458|NCT01234831|Other|Nasal swab culture|Nasal swabs are obtained if the clinician caring for the patient identifies the patient as eligible to be screened for colonization. An algorithm for screening eligible patients is available electronically as part of the patient's standard medical record to the clinicians providing care.
16220459|NCT01234818|Device|Mirena (LNG-IUS)|General Name/Brand name: Mirena - Bayer ② Active ingredient: levonorgestrel 52mg ③ Description: Mirena is a hormone-releasing T-shaped intrauterine system. A removal thread is attached to a loop at the end of the vertical stem of the T-body.
16220460|NCT01234805|Procedure|yoga therapy|Participates in yoga classes and yoga at home
16220461|NCT01234805|Other|questionnaire administration|Ancillary studies
16220462|NCT01234805|Procedure|quality-of-life assessment|Ancillary studies
16220463|NCT01234792|Drug|6 mg Experimental nicotine gum|A single 6 mg dose of an experimental nicotine gum, with a 36-hour washout between visits
16220464|NCT01234792|Drug|4 mg Nicotine Gum/|A single 4 mg dose of Nicorette® gum, with a 36-hour washout between visits
16220465|NCT01234792|Drug|2 mg Nicotine Gum|A single 2 mg dose of Nicorette® gum, with a 36-hour washout between visits
16220466|NCT01234779|Drug|bitopertin [RO4917838]|10 mg orally daily, 4 weeks
16220467|NCT01234779|Drug|bitopertin [RO4917838]|30 mg orally daily, 4 weeks
16220468|NCT01234779|Drug|olanzapine|15 mg orally daily, 4 weeks
16220469|NCT01234779|Drug|placebo|orally daily, 4 weeks
16220470|NCT01234766|Drug|Bendamustine|90mg/m2, IV - Days 1 and 2 of every cycle
16220471|NCT01234766|Drug|Rituximab|375mg/m2, IV - Cycle 1 only: Day -7 (+1 day) Day 1 of every cycle
16220472|NCT01234766|Radiation|Y-90 ibritumomab|0.4mCi/kg, IV - Within 4 hours of rituximab, give over 10 minutes
16220473|NCT01234753|Other|Physician and nurse consultation|Usual care by a visit to physician at the hospital out-patient clinic and computer-based and individual education and psychosocial support by a nurse-led session.
16220474|NCT01234740|Drug|bafetinib|Given orally
16220475|NCT01234740|Procedure|microdialysis|Catheter placed intracerebrally during debulking craniotomy or stereotactic biopsy
16220476|NCT01234740|Other|pharmacological study|Correlative studies
16220477|NCT01234740|Other|liquid chromatography|Correlative studies
16220478|NCT01234740|Other|mass spectrometry|Correlative studies
16220479|NCT01234740|Other|laboratory biomarker analysis|Correlative studies
16220480|NCT01234740|Genetic|protein expression analysis|Correlative studies
16220481|NCT01234740|Genetic|western blotting|Correlative studies
16220482|NCT01234740|Other|immunohistochemistry staining method|Correlative studies
16220483|NCT01234740|Procedure|therapeutic conventional surgery|debulking craniotomy
16220484|NCT01234714|Other|Non-invasive Magnetic Resonance Imaging (MRI)|Conventional pre-operative MRI
16220485|NCT01234714|Procedure|Major liver resection|Hepatectomy of >= 3 liver segments
16220486|NCT01234701|Other|Non-invasive Magnetic Resonance Imaging (MRI)|Conventional pre-operative MRI
16220487|NCT01234701|Procedure|Liver resection|Hepatectomy with an intention to cure
16220488|NCT01234701|Other|Histopathology diagnosis of resected liver specimen|Histopathology diagnosis by expert pathologist.
16220489|NCT01234688|Other|Exercise training|Patients included in the exercise group were submitted to intra-dialytic exercise training, 3 times per week for 12 weeks.
16220490|NCT01234675|Drug|Milnacipran|50 mg twice daily
16220491|NCT01234675|Drug|Placebo|50 mg twice daily
16220492|NCT01234662|Procedure|SPA|Spinal anesthesia and opioids
16220493|NCT01234662|Procedure|CSE|CSE and epidural opioids
16220494|NCT01234662|Procedure|CSEPCEA|CSE and continuous epidural patient controlled analgesia using an epidural catheter for 24 hrs
16220495|NCT01234649|Drug|Metformin XR plus placebo|Metformin plus Placebo Metformin 500 mg qd 2 weeks 500 mg bid 2 weeks 500 mg am, 1000 mg pm- 2 weeks 1000 mg bid -98 weeks (end study) Placebo-start 1 injection SC QD step up to a max dose as tolerated
16220496|NCT01234649|Drug|Metformin XR plus liraglutide|Metformin XR-500 qd for 2 weeks, 500 mg bid 2 weeks; 500 mg am, 1000 mg pm- 2 weeks - 1000 bid final dose Liraglutide- start 0.6 mg SC QD step up to 1.2 mg to a max dose of 1.8 mg SC QD as tolerated during the 4-wk non-forced dose-escalation period ( maximum allowed dose of 1.8 mg SC QD)
16220497|NCT01234636|Dietary Supplement|Placebo oil|Placebo oil of 4g/day
16220498|NCT01234623|Other|UCS eyedrops|1 ml UCS eyedrops/day topically applied 8 times/day 1 drop/eye for 28 days
16220499|NCT01234610|Behavioral|Supervised exercise training|Patients will be asked to attend three exercise sessions per week for 12 weeks. They will exercise in groups of up to four per session and they will be supervised by an experienced exercise physiologist. Each session will comprise 5 to 10 min warm-up period (involving very light aerobic exercise and a range of gentle movements), 30 min of light-to-moderate intensity aerobic exercise (cycle-ergometry and or treadmill-walking), and a 5 to 10 min cool-down period involving low-intensity aerobic exercise and gentle stretching. The intensity of the aerobic exercise will be individualised and will be progressed gradually (if appropriate) during the course of the study.
16220500|NCT01234597|Drug|INSULIN GLARGINE (HOE901)|Pharmaceutical form: solution for injection Route of administration: subcutaneous
16220502|NCT01234584|Procedure|spk|implants using SPK Abutments
16220505|NCT01234545|Drug|activated recombinant human factor VII|Prescription is done at the discretion of the prescribing physician as part of normal clinical routine
16220506|NCT01234532|Drug|entinostat|orally
16220507|NCT01234532|Drug|anastrozole|Given PO
16220508|NCT01234532|Other|diagnostic laboratory biomarker analysis|"Correlative studies will be performed utilizing tissue and blood. A baseline tumor biopsy is done prior to study entry or archival tissue from diagnosis may be used and a representative tumor sample is submitted at time of surgery.
~Bloods are drawn for correlative sciences on day 1 and 15 of treatment prior to entinostat dosing and 30 mins post and again on day of surgery."
16220509|NCT01234532|Procedure|therapeutic conventional surgery|Lumpectomy or mastectomy will be performed follwoing day 29 of study therapy
16220510|NCT01234519|Drug|AEZS-108|128, 160, 210 or 267 mg/m2, 2-hour intravenous (IV) infusion, Day 1 of 21-day cycles , until toxicity or progression, up to 6 cycles
16220511|NCT01234519|Drug|AEZS-108 at MTD|2-hour IV infusion, Day 1 of 21-day cycles , until toxicity or progression, up to 6 cycles
16220512|NCT01234506|Dietary Supplement|secoisolariciresinol diglucoside|SDG supplementation as a packet of 0.8g/day of BeneFlax containing 300 mg SDG for 24 weeks
16220513|NCT01234493|Procedure|fixation|Syndesmosis fixation with one 3.5mm fully threaded three cortical screw
16220514|NCT01234493|Procedure|no fixation|No syndesmosis fixation.
16220515|NCT01234480|Device|BD SurePath Plus Pap test|BD SurePath Plus Pap test
16220516|NCT01234480|Device|BD SurePath Pap test|BD SurePath Plus Pap test
16220517|NCT01234480|Procedure|colposcopy with biopsy/ECC|Colposcopy with biopsy/ECC for subjects with 1)BD SurePath Pap NILM, but HPV positive, or 2) BD SurePath Plus Pap test result of ASC-US or higher 3)BD SurePath Pap ASC-US or higher
16220518|NCT01234480|Device|HPV DNA test|digene HC2 HPV DNA test
16220519|NCT01234467|Drug|Bendamustine|Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles
16220520|NCT01234467|Drug|Rituximab|Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles
16220521|NCT01234454|Drug|Risperidone|6mg/day or highest dose tolerated for 8 weeks, following 4 weeks baseline treatment of Thiothixene
16220522|NCT01234454|Drug|Olanzapine|20mg/day for 8 weeks, following 4 weeks of baseline Thiothixene.
16220523|NCT01234441|Dietary Supplement|Control|A placebo non-nutritive beverage will be administered before dialysis sessions 3 times per week.
16220524|NCT01234441|Dietary Supplement|Protein|A whey protein beverage will be administered before dialysis sessions 3 times per week.
16220525|NCT01234441|Behavioral|Protein + Exercise|A whey protein beverage will be administered before dialysis sessions 3 times per week. Patients will also exercise by stationary bicycle during dialysis sessions 3 times per week.
16220526|NCT01234428|Procedure|Laparoscopic surgery|Gastric banding
16220527|NCT01234428|Procedure|gastric banding|laparoscopic gastric banding
16220528|NCT01234415|Device|Rhinoplasty|Rhinoplasty is performed under general anaesthesia; the duration is 1 to 2 hours. The surgical approach for implantation of the biomaterial is external rhinoplasty. The incision is made at the columella (base of nose) and becomes internal for the scar to be as unobtrusive as possible. The septum skeleton is then destroyed in order to place the synthetic biomaterial. The biomaterial is remodelled in order to have a natural external aspect of the nose. The incision is closed and the wicks are put in place in the nose for 4 days. A cast and a sticker will be put in place after surgery to maintain properly the biomaterial.
16220529|NCT01234402|Biological|Ramucirumab DP|"10 mg/kg I.V.
~Day 1 of every-21-day cycle"
16220530|NCT01234402|Biological|IMC-18F1|"12 mg/kg I.V.
~Days 1 and 8 of every-21-day cycle"
16220531|NCT01234402|Drug|Capecitabine|"1000 mg/m^2 orally
~Twice a day for 14 days"
16220532|NCT01234389|Device|Electrochemical H. pylori detection method|Determination of H. pylori infection.
16220533|NCT01234389|Device|IHC|Determination of H. pylori infection.
16220534|NCT01234389|Device|C13-urea breath test|Determination of H. pylori infection.
16220535|NCT01234389|Device|HUT|Determination of H. pylori infection.
16220536|NCT01234376|Device|Confocal laser endomicroscopy|Confocal laser endomicroscopy
16220537|NCT01234363|Device|Magnetic Resonance Elastography, and Supersonic Shear Imaging|Magnetic Resonance Elastography, and Supersonic Shear Imaging
16220538|NCT01234337|Drug|Sorafenib (Nexavar, BAY43-9006)|Capecitabine was administered orally at a dose of 1,000 milligram per square meter (mg/m^2) twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Sorafenib was administered orally at a dose of 600 mg (200 mg in the morning, 400 mg in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and sorafenib dose to a total daily dose of 800 mg for that subject.
16220539|NCT01234337|Drug|Placebo|Capecitabine was administered orally at a dose of 1,000 mg/m^2 twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle. Placebo matching to sorafenib was administered orally, 3 tablets (1 tablet in the morning, 2 tablets in the evening) daily, continuously (that is, Days 1 to 21, inclusive). A treatment cycle consisted of 21 days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily and placebo dose to a total daily dose of 4 tablets (2 tablets twice daily) for that subject.
16220540|NCT01234337|Drug|Capecitabine|Capecitabine was administered orally at a dose of 1,000 milligram per square meter (mg/m^2) twice daily (12 hours apart) on Days 1 through 14 of each 21-day cycle.days. If tolerability criteria were met for a subject, capecitabine dose was escalated to 1,250 mg/m^2 twice daily,
16220541|NCT01234324|Drug|Epirubicin, Cisplatin, Capecitabine, Panitumumab|Epirubicin: 50mg/m², administered as an intravenous bolus over 10min on day 1 of each 21 day cycle; Cisplatin: 60mg/m², administered as an intravenous infusion over 4h on day 1 of each 21 day cycle; Capecitabine: 625mg/m², administered orally twice daily on each day of each 21 day cycle; Panitumumab: 9 mg/kg bodyweight, administered IV by an infusion pump through a peripheral line or catheter over 60 min +-15 min on day 1 of each 21 day cycle. Number of Cycles: 3 neoadjuvant cycles and 3 adjuvant cycles until disease progression, withdrawal of consent or unacceptable toxicity develops.
16220577|NCT01234038|Drug|ISIS EIF4E Rx|800 mg ISIS EIF4E Rx administered as a 3-hour intravenous infusion on Days 1, 8 and 15 of each 21 day cycle
16220542|NCT01234324|Drug|Epirubicin, Cisplatin, Capecitabine|Epirubicin: 50mg/m², administered as an intravenous bolus over 10min on day 1 of each 21 day cycle; Cisplatin: 60mg/m², administered as an intravenous infusion over 4h on day 1 of each 21 day cycle; Capecitabine: 625mg/m², administered orally twice daily on each day of each 21 day cycle. Number of Cycles: 3 neoadjuvant cycles and 3 adjuvant cycles until disease progression, withdrawal of consent or unacceptable toxicity develops.
16220543|NCT01234311|Drug|tasquinimod|Tasquinimod up to a maximum maintenance dose of 1 mg once daily, administrated orally (capsule)
16220544|NCT01234311|Drug|Placebo|
16220545|NCT01234298|Drug|SPD489 Low-Dose|SPD489 20, 30, or 40 mg capsules taken once-daily for up to 26 weeks
16220546|NCT01234298|Drug|SPD489 High-Dose|SPD489 50, 60, or 70 mg capsules taken once-daily for up to 26 weeks
16220547|NCT01234298|Drug|Placebo|Placebo capsule taken once-daily for up to 26 weeks
16220548|NCT01234285|Drug|heparin|intravenous heparin titrated to an aPTT of 40-50 seconds starting between 300-500 units per hour and adjusted every 6 hours based on aPTT, starting within 24 hours of ICU admission up to 6 days.
16220549|NCT01234285|Drug|heparin|intravenous heparin titrated to an aPTT of 50-60 seconds starting between 300-500 units per hour and adjusted every 6 hours based on aPTT, starting within 24 hours of ICU admission up to 6 days.
16220550|NCT01234285|Drug|heparin|intravenous heparin titrated to an aPTT of 40-45 seconds starting between 300-500 units per hour and adjusted every 6 hours based on aPTT, starting within 24 hours of ICU admission up to 6 days.
16220551|NCT01234285|Drug|heparin|5000 units subcutaneously three times a day, starting within 24 hours of ICU admission up to 6 days.
16220552|NCT01234272|Drug|morphine|ITM-IVPCA: intrathecal administration of 0.3 mg morphine before induction of general anesthesia and application of IVPCA (basal infusion: fentanyl 0.4mcg/kg/hr, bolus: 0.16mcg/kg of fentanyl with a lock out time of 15 min)
16220553|NCT01234272|Drug|Ropivacaine|PCEA: epidural administration of 5ml 0.2% ropivacaine before induction of general anesthesia and application of PCEA (basal infusion: 5ml 0.2% ropivacaine with fentanyl 0.4 mcg/kg/hr, bolus: 2ml 0.2% ropivacaine with fentanyl 0.16mcg/kg with a lockout time 15min)
16220554|NCT01234259|Device|Venus Freeze (MP2 V2 System|Facial wrinkles and temporary cellulite and circumference reduction treatments
16220555|NCT01234233|Procedure|duration of preoperative active warming|"duration of prewarming by forced air warming"
16220556|NCT01234207|Device|Standard, non-free-form, non-customized PAL spectacles|Control spectacles include several different PAL brands as selected by patients in the UC Berkeley Optometry Clinic and purchased in the Eyewear Center; after successful fitting and purchase, potential subjects were recruited for the trial.
16220557|NCT01234207|Device|Individually customized free-form surfaced PAL spectacles|Test spectacles are Zeiss Individual, free-form surfaced, and customized using the iTerminal device to account for individual back vertex distance, wrap angle and pantoscopic tilt
16220558|NCT01234194|Drug|rising remifentanil concentrations|remifentanil effect-compartment concentrations 0,1,2,3 ng/ml
16220559|NCT01234194|Drug|falling remifentanil concentrations|remifentanil effect-compartment concentrations 3, 2, 1, 0 ng/ml
16220560|NCT01234181|Procedure|Hypoxia-stressed BMSCs transplantation to cure MI|Experimental group: intracoronary injection of 10^7 BMSCs Sham Comparator: inject the same volume saline
16220561|NCT01234155|Behavioral|Exercise Training - Interval Walking|Duration: 4 months. Exercise training sessions will be performed 3-5 days/week. Sessions will consist of walking for 3 minutes at 70% VO2max followed by 3 minutes at 40% VO2max for up to 60 minutes/day.
16220562|NCT01234155|Behavioral|Exercise - Continuous Walking|Duration: 4 months. Exercise training sessions will be performed 3-5 days/week and will consist of walking for up to 60 minutes/day at 55% VO2max.
16220563|NCT01234142|Drug|varenicline free base patch|varenicline transdermal delivery system (12.0 mg payload [drug amount loaded in each patch]) will be applied to the skin once daily for 14 days
16220564|NCT01234142|Drug|varenicline free base patch|varenicline transdermal delivery system (18.0 mg payload [drug amount loaded in each patch]) will be applied to the skin once daily for 14 days
16220565|NCT01234142|Drug|placebo patch|Matched placebo transdermal delivery system will be applied to the skin once daily for 14 days
16220566|NCT01234142|Drug|varenicline free base patch|varenicline transdermal delivery system (24.0 mg payload [drug amount loaded in each patch]) will be applied to the skin once daily for 14 days
16220567|NCT01234142|Drug|placebo patch|Matched placebo transdermal delivery system will be applied to the skin once daily for 14 days
16220568|NCT01234142|Drug|varenicline free base patch|2 varenicline transdermal delivery systems (combined to achieve a maximum drug payload of 36 mg) will be applied to the skin, side by side once daily, for 14 days
16220569|NCT01234142|Drug|placebo patch|Matched placebo transdermal delivery systems will be applied to the skin, side by side, once daily for 14 days
16220570|NCT01234129|Drug|zoledronic acid|zoledronic acid, 4 mg,standard dose,at monthly interval, by 2 years
16220571|NCT01234116|Drug|emtricitabine/tenofovir disoproxil fumarate|Each health care worker will receive one of the Treatment Arms for 28 days.
16220572|NCT01234103|Behavioral|Preventing Helath Damaging Health Behaviors in Male and Female Army Recruits|Groups will be randomly assigned to the sexual/substance use prevention intervention or the comparative/control intervention focused on impro risk Involves 10 hours of didactic presentations, interactive group discussions, skills-building exercises, and topic specific videos to reduce participants' risk for and acquisition of STIs, unintended pregnancies and their associated sexual and substance use behaviors.
16220573|NCT01234077|Device|CPC M1|CPC M1
16220574|NCT01234064|Device|Anti-Embolism Graduated Pressure Stockings (by BSN-Jobst)|Apply 2 to 4 hours prior to surgery. Patient will continue to wear stockings until post-op Day 10.
16220575|NCT01234064|Device|No Graduated Compression Stockings|No stockings will be applied.
16220576|NCT01234051|Drug|Docetaxel, Oxaliplatin|"1. Treatment Schedule
~1.1. Docetaxel schedule Docetaxel 35 mg/m2 is administered on day 1 and day 8 by intravenously in 100 mL of 5% dextrose solution over 30 minutes. Dexamethasone 8mg is intravenously administered before 30 minutes, and then orally 4mg every 12 hours over 48 hours. In the event of a hypersensitivity reaction, dimethidine maleate, epinephrine, and intravenous fluids will be required.
~1.2. Oxaliplatin schedule Oxaliplatin 100 mg/m2 is given on day 1 by intravenous infusion in 500 mL of 5% dextrose solution over 120 minutes. Therapy will be repeated every 21 days."
16220578|NCT01234038|Drug|ISIS EIF4E Rx|1000 mg ISIS EIF4E Rx administered as a 3-hour intravenous infusion on Days 1, 8 and 15 of each 21 day cycle
16220579|NCT01234038|Drug|ISIS EIF4E Rx|(Dose identified in Part 1)ISIS EIF4E Rx administered as a 3-hour intravenous infusion on Days 1, 8, and 15 of each 21 day cycle
16220580|NCT01234038|Drug|Paclitaxel|200 mg/m2 administered as a 3-hour intravenous infusion on Day 1 of each 21 day cycle
16220581|NCT01234038|Drug|Carboplatin|AUC 6.0 mg/mL/min administered as a 1-hour intravenous infusion on Day 1 of each 21 day cycle
16220582|NCT01234025|Drug|ISIS EIF4E Rx|800 mg ISIS EIF4E Rx administered as a 3-hour intravenous infusion on Days 1, 8 and 15 of each 21 day cycle.
16220583|NCT01234025|Drug|ISIS EIF4E Rx|1000 mg ISIS EIF4E Rx administered as a 3-hour intravenous infusion on Days 1, 8 and 15 of each 21 day cycle.
16220584|NCT01234025|Drug|ISIS EIF4E Rx|(Dose identified in Part 1)ISIS EIF4E Rx administered as a 3-hour intravenous infusion on Days 1, 8 and 15 of each 21 day cycle.
16220585|NCT01234025|Drug|Prednisone|5 mg administered orally twice daily on days 1, 8, 15 and 22 of each cycle
16220586|NCT01234025|Drug|Docetaxel|75 mg/m2 administered as a 1-hour intravenous infusion on day 1 of each cycle
16220587|NCT01234012|Biological|IMF-001|subcutaneous injection of fixed dose IMF-001 (100 or 200 mcg) every 2 weeks.
16220588|NCT01233999|Drug|botulinum toxin A|Botulinum toxin A will be injected into participants hand total 40units
16220589|NCT01233973|Other|video decision aid|video
16220590|NCT01233960|Drug|adult human mesenchymal stem cells|PROCHYMAL will be administered IV in a total volume of 300 ml (200 million cells) at a rate of 4-6 ml/minute. Treatments will be administered on Days 42-45, Days 84-87, and Days 126-129 following first infusion in Protocol 603.
16220591|NCT01233947|Drug|AFP464|AFP464 administered as a 3-hour IV infusion on Days 1 and 8 of a 21-day cycle
16220592|NCT01233947|Drug|AFP464 + Faslodex|AFP464 administered as a 3-hour IV infusion on Days 1 and 8 of a 21-day cycles and faslodex administered per the package label
16220593|NCT01233934|Drug|Dexchlorpheniramine 1% Gel|Small amount applied over the lesion twice a day for 7 days.
16220594|NCT01233934|Drug|Dexchlorpheniramine 1% Cream|Small amount applied over the lesion twice a day for 7 days.
16220595|NCT01233921|Biological|palifermin|Given IV
16220596|NCT01233921|Other|flow cytometry|Correlative studies
16220597|NCT01233921|Other|laboratory biomarker analysis|Correlative studies
16220598|NCT01233921|Other|pharmacological study|Correlative studies
16220599|NCT01233895|Drug|AVE1642|For Part 1, AVE1642 was administered on Day 1 and then every three weeks intra-venously with the dose escalation step starting at 3 mg/kg/infusion with a classical dose escalation schema of 3+3. For Part 2, AVE1642 was administered at doses ranging from 0.5 mg/kg to 12 mg/kg
16220600|NCT01233895|Drug|Velcade|For Part 2 ONLY, fixed dose of 1.3 mg/m² administered on Days 1, 4, 8, and 11.
16220601|NCT01233882|Drug|Bosutinib|Single dose of 200 mg of bosutinib in subjects with normal renal function
16220602|NCT01233882|Drug|Bosutinib|Single dose of 200 mg of bosutinib in subjects with mild renal impairment
16220603|NCT01233882|Drug|Bosutinib|Single dose of 200 mg of bosutinib in subjects with moderate renal impairment
16220604|NCT01233882|Drug|Bosutinib|Single dose of 200 mg of bosutinib in subjects with severe renal impairment
16220605|NCT01233869|Drug|Bosutinib|Once daily oral dose of 200 mg of bosutinib
16220606|NCT01233869|Drug|Bosutinib|Once daily oral dose of 400 mg of bosutinib transitioned to 200 mg/day
16220607|NCT01233869|Drug|Placebo|Once daily oral dose of placebo
16220608|NCT01233843|Drug|carboplatin|70 mg per m2 and per day for four days. day 1; day 22; day 43
16220609|NCT01233843|Drug|5 fluorouracil|600mg per m2 per day for four days. 3 cycles day 1; day 22; day 43
16220610|NCT01233843|Radiation|radiation therapy|total dose: 70 grays. The patient receives 2 grays per day; five days a week during 7 weeks
16220611|NCT01233830|Drug|AZD2423|oral solution
16220612|NCT01233830|Drug|Placebo|oral solution
16220613|NCT01233817|Other|Progressive strength training|the systematic increase in resistance weights
16220614|NCT01233804|Other|Opting Out|Usual care is for pregnant women to sign a consent to get the influenza vaccine. The intervention is to offer a group of women the option to sign only when they refuse the influenza vaccine.
16220615|NCT01233791|Drug|Vaginal Diazepam Suppository|10mg compounded vaginal suppository
16220616|NCT01233791|Drug|Placebo Suppository|Patients will be asked to use one vaginal suppository every night for 28 days
16220617|NCT01233778|Dietary Supplement|Canola Oil|60g Canola oil daily per 3000kcal diet provided in a supplemental shake
16220618|NCT01233778|Dietary Supplement|High Oleic Acid + DHA Canola Oil|60g high oleic acid canola oil + DHA daily per 3000kcal provided in a supplemental shake
16220619|NCT01233778|Dietary Supplement|High Oleic Acid Canola Oil|60g high oleic acid canola oil daily per 3000kcal provided in a supplemental shake
16220620|NCT01233778|Dietary Supplement|Flax Oil|36g flax oil + 24g safflower oil daily per 3000kcal provided in a supplemental shake
16220621|NCT01233778|Dietary Supplement|Safflower Oil|45g safflower oil + 15g corn oil daily per 3000kcal provided in a supplemental shake
16220622|NCT01233752|Drug|morphine chlorhydrate|"The drug will be administrated by a bolus 45 minutes before the end of the surgery, with the following modalities: bolus with morphine chlorhydrate 0.15 mg/kg ± 20%. Also acetaminophene 1g and ketoprofen 160 mg (ketorolac 30mg) will be administrated during the operation.
~At the exit of the operative compartment patients will have an electronic pump (PCA) for 48h with morphine chlorhydrate to be used in boluses by 1 mg with a lock out of 5 mins, max dose 20 mg in 4 hours.
~Moreover, ketoprofen will be prescribed 160 mg x 2 per day (ketorolac 30mg x 2) (in case of allergy acetaminophene 1g x 3 daily).
~Postoperative analgesic treatment is lasting 48h for each patient (between starting of the PCA infusion (T0) and the following 48h)."
16220623|NCT01233739|Drug|Chondroitin sulfate|Administration of 2 capsules of 400 mg of chondroitin sulfate orally.
16220624|NCT01233739|Drug|Placebo|Administration of 2 capsules of placebo orally.
16220625|NCT01233726|Dietary Supplement|T-Diet plus Diabet IR|Group 1 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.
16220626|NCT01233726|Dietary Supplement|ISOSOURCE PROTEIN FIBRE|Group 2 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.
16220627|NCT01233726|Dietary Supplement|GLUCERNA SELECT|Group 3 will receive, 25 kcal / kg • day for 28 days, via gastric or transpyloric.
16220628|NCT01233713|Procedure|Hartmann's operation|Hartmann's operation is the surgical resection of the rectosigmoid colon with closure of the rectal stump and end colostomy, followed by a stoma reversal operation.
16220629|NCT01233713|Procedure|Primary anastomosis|Primary anastomosis refers to a colonic resection with primary anastomosis and covering proximal ileostomy, followed by a stoma reversal operation.
16220630|NCT01233700|Behavioral|Motivational Interviewing|Standard motivational interviewing techniques will be applied to assist subjects to consider and work to resolve any remaining concerns, doubts, or ambivalence about their decision about donating an organ to someone else.
16220631|NCT01233700|Behavioral|Healthy Lifestyles Education|Educational information will be presented to subjects in didactic form on lifestyles issues of relevance to living donors.
16220632|NCT01233687|Drug|AMG 102 and erlotinib|"Dose Level -2 Dose level -1 Dose Level 0 AMG 102 5 mg/kg 7.5 mg/kg 15 mg/kg Erlotinib 150 mg 150 mg 150 mg
~The first cohort of patients in the phase I portion will start at dose level 0 of AMG102."
16220633|NCT01233661|Other|short AVD pacing ; prior (stable) programming|short AVD pacing prior (stable) programming
16220634|NCT01233648|Other|rate control via CRT-D and AVN ablation|rate control
16220635|NCT01233648|Other|rhythm control via pharmacologic, electrical or ablative therapies|rhythm control
16220636|NCT01233635|Other|no drug|none, no drug
16220637|NCT01233635|Drug|start cozaar|start cozaar
16220638|NCT01233635|Drug|continue cozaar|continue cozaar
16220639|NCT01233622|Drug|Vildagliptin|
16220640|NCT01233622|Drug|Placebo|
16220641|NCT01233609|Drug|Valproic Acid|One to four 250mg softgels by mouth daily (dose determined by body weight)
16220642|NCT01233609|Drug|Placebo|Dosage per subject weight- same schedule as the active comparator
16220643|NCT01233596|Device|Canalicular intubation|Intubation through the inferior canaliculus performed under general anaeshesia. The tubes were removed 3-4 months after the tube placement.
16220644|NCT01233583|Drug|Dovobet, neotigason, etanercept, adalimumab. infliximab|Dovobet ointment 15g/day for 6 weeks Neotigason capsule 50mg per day (oral) for 6 weeks Enbrel 50mg twice weekly subcutaneous injection for 6 weeks Humira 80mg week 0, 40 mg week 1 then every other week therafter subcutaneous injection for 6 weeks Remicade 3 separate doses of 5mg/kg intavenous injection for 6 weeks
16220645|NCT01233570|Drug|Tacrolimus|Once daily application for 12 weeks followed by 4 weeks observation. Optional 36 week open label extension
16220646|NCT01233544|Procedure|SBRT or RFA|Patients are allocated to one of the two arms in a 1:1 randomization
16220647|NCT01233531|Behavioral|monthly cash transfer payments for attending school|In the intervention, young women and their households will be randomized in 1:1 ratio to receive monthly cash transfer payments, conditional on the young woman attending school, or to the control arm. Young women will be recruited at the beginning of grades 8 through 11 in the first year of the study.
16220648|NCT01233531|Behavioral|B--No cash transfers|No monthly cash transfers
16220649|NCT01233518|Device|FFR|Fractional flow reserve measured during cardiac catheterization
16220650|NCT01233505|Drug|veliparib|Given PO
16220651|NCT01233505|Drug|capecitabine|Given PO
16220652|NCT01233505|Drug|oxaliplatin|Given IV
16220653|NCT01233505|Other|pharmacological study|Correlative studies
16220654|NCT01233505|Other|laboratory biomarker analysis|Correlative studies
16220655|NCT01233492|Drug|boron phenylalanine|
16220656|NCT01233492|Drug|mannitol|
16220657|NCT01233492|Other|biologic sample preservation procedure|
16220658|NCT01233492|Radiation|radiation therapy treatment planning/simulation|
16220659|NCT01233479|Drug|systemic chemotherapy|
16220660|NCT01233479|Other|laboratory biomarker analysis|
16220661|NCT01233479|Procedure|therapeutic surgical procedure|
16220662|NCT01233479|Radiation|radiation therapy|
16220663|NCT01233453|Device|the everolimus eluting ® stent|stenting in coronary artery disease using the XIENCE-V®, XIENCE-Prime® or PROMUS® stent
16220664|NCT01233453|Device|the Biolimus A9 eluting NOBORI® stent|stenting in coronary artery disease using the Biolimus A9 eluting NOBORI® stent
16220665|NCT01233440|Biological|Recombinant Coagulation Factor IX Albumin Fusion Protein|Single dose of 25, 50 or 75 IU/kg of rIX-FP, given as intravenous infusion
16220666|NCT01233440|Biological|Plasma derived FIX [pdFIX]|Single dose of 50 IU/kg of reference product, given as intravenous infusion
16220667|NCT01233414|Behavioral|Parent Training|The Parent Training program will be delivered individually to the parents of study participants. Families will attend up to 13 90-minute treatment sessions over a 24-week period. Topics covered in the program include reinforcement, teaching compliance, and functional communication. The treatment sessions employ direct instruction, review of video-taped examples, practice activities, behavior rehearsal with feedback, and role-playing to accomplish specific skill acquisition. Parents will be given specific homework assignments between sessions.
16220668|NCT01233414|Other|Psychoeducational Program|The Psychoeducational program will be delivered individually to the parents of study participants. Families will attend up to 13 90-minute informational sessions over a 24-week period. The program provides an overview on a variety of topics including the complexities of a PDD diagnosis, co-occurring medical conditions, relevant aspects of child development, use of medications, treatment options for challenging behavior, nutritional issues, and complementary and alternative treatments.
16220669|NCT01233401|Other|Survey|Mothers and Other infant caregivers are surveyed at the end of the 2 week newborn well child visit about whether they chose to receive the Tdap vaccine at the pediatrician's office.
16220670|NCT01233388|Other|Text message surveillance|Text message surveillance for vaccine adverse events
16220671|NCT01233375|Drug|CO-1.01|"1250 mg/m2/day administered on Days 1, 8, and 15 in 4-week treatment cycles.
~Patients who have SD or better at the Week 8 assessment and who adequately tolerated the first 2 cycles of treatment may continue CO-1.01 at the same or an increased dose (1400 mg/m2) for Cycle 3 and subsequent cycles."
16220672|NCT01233362|Biological|Modified killed oral cholera vaccine at 14 day interval|The modified killed bivalent (O1 and O139)whole cell based oral cholera vaccine is administered orally in 2 liquid doses (without need of any buffer solution) 14 days for individuals aged 1 year and above.
16220714|NCT01233024|Dietary Supplement|Resistant starch|Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.
16220673|NCT01233362|Biological|Modified killed oral cholera vaccine at 28 day interval|The modified killed bivalent (O1 and O139)whole cell based oral cholera vaccine is administered orally in 2 liquid doses (without need of any buffer solution) 28 days for individuals aged 1 year and above; as an alternate schedule.
16220674|NCT01233349|Device|Litramine|2 tablets 3 times daily (oral consumption, 30 minutes after meal)
16220675|NCT01233349|Device|Placebo|2 tablets 3 times daily (oral consumption, 30 minutes after meal)
16220676|NCT01233297|Drug|Azithromycin|10 mg/kg peroral for 3 consecutive days
16220677|NCT01233297|Other|Placebo mixture|Placebo mixture containing no active substance.
16220678|NCT01233284|Drug|tiotropium bromide 2.5µg once daily|Efficacy and safety comparison of 3 doses of inhaled tiotropium (1.25µg, 2.5µg and 5µg) versus placebo
16220679|NCT01233284|Drug|Tiotropium matching Placebo once daily|Efficacy and safety comparison of 3 doses of inhaled tiotropium (1.25µg, 2.5µg and 5µg) versus placebo
16220680|NCT01233284|Drug|tiotropium bromide high dose once daily|Efficacy and safety comparison of 3 doses of inhaled tiotropium (1.25µg, 2.5µg and 5µg) versus placebo
16220681|NCT01233284|Drug|tiotropium bromide 1.25µg once daily|IMP
16220682|NCT01233271|Device|Space TGC|Space TGC with incorporated eMPC algorithm to establish glycaemic control with a blood glucose target range of 80-150 mg/dL (4.4-8.3 mM)
16220683|NCT01233258|Biological|rFVIII (BAY81-8973) on demand|Participants received on-demand treatment with rFVIII (BAY81-8973) assayed by CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) for 6 months and by CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) for 6 months, sequence according to randomization
16220684|NCT01233258|Biological|rFVIII (BAY81-8973) prophylaxis low-dose|Participants received low dose prophylaxis treatment at 20, 25 or 30 IU/kg twice per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.
16220685|NCT01233258|Biological|rFVIII (BAY81-8973) prophylaxis high-dose|Participants received high dose prophylaxis treatment at 30, 35 or 40 IU/kg 3 times per week with rFVIII (BAY81-8973) assayed by CS/EP for 6 months and by CS/ADJ for 6 months, sequence according to randomization.
16220686|NCT01233245|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|250 µg, sub-cutaneously, on alternate days
16220687|NCT01233232|Drug|Placebo|Oral dose bid
16220688|NCT01233232|Drug|AZD5069 50mg|Oral dose bid
16220689|NCT01233232|Drug|AZD5069 80mg|Oral dose bid
16220690|NCT01233219|Drug|morphine chlorhydrate|"The drug will be administrated by a bolus 45 minutes before the end of the surgery, with the following modalities: bolus with morphine chlorhydrate 0.15 mg/kg ± 20%. Also acetaminophene 1g and ketoprofen 160 mg (ketorolac 30mg) will be administrated during the operation.
~At the exit of the operative compartment patients will have an continuous infusion for 48h with morphine chlorhydrate 0,02 mg/kg/h.
~Moreover, a rescue dose therapy will be prescribed with ketoprofen 160 mg or ketorolac 30mg (in case of allergy acetaminophene 1g) if NRS<4 maximum x 3 daily.
~Postoperative analgesic treatment is lasting 48h for each patient (between starting of the infusion (T0) and the following 48h)."
16220691|NCT01233206|Drug|Metformin|Metformin pre-treatment and co-administration
16220692|NCT01233206|Drug|Placebo administration|Placebo pre-treatment and co-administration
16220693|NCT01233193|Behavioral|Health education, Home blood pressure monitoring|Health education (on hypertension, smoking, healthy diet, obesity, physical inactivity and adherence to antihypertensive medications and home blood pressure monitoring) . The patient will be referred to physician when needed. The patient will be followed up during 6 months.
16220694|NCT01233180|Other|Gua Sha|Single Gua Sha treatment of the neck and shoulder region
16220695|NCT01233180|Device|Thermotherapy|Single use of a mud heat pad on the neck and shoulder region
16220696|NCT01233167|Drug|clopidogrel|clopidogrel 75 mg po per day for 12 months
16220697|NCT01233167|Drug|placebo|placebo 75mg po per day for 12 months
16220698|NCT01233167|Drug|clopidogrel and placebo|clopidogrel 50mg per day for 3 months,clopidogrel 25mg per day for 3 months,then placebo 75mg per day for 6 months
16220699|NCT01233154|Dietary Supplement|probiotic|
16220700|NCT01233154|Dietary Supplement|probiotic|
16220701|NCT01233102|Drug|Conserved Therapy|Conserved Therapy
16220702|NCT01233102|Procedure|Hepatic artery infusion or Intravenous infusion|Patients with liver cirrhosis will be randomly divided into three groups. Umbilical cord MSCs will be infused to patients using interventional method via hepatic artery for one group. The catheter will be inserted to proper hepatic artery. After the catheter placement confirmed by angiography, umbilical cord MSCs will be infused slowly in 20-30 minutes. Umbilical cord MSCs will be infused intravenously slowly for 30-60 minutes in the intravenous infusion group. The control group will receive conserved therapy.
16220703|NCT01233089|Device|Lotrafilcon B contact lens, investigational|Investigational silicone hydrogel, spherical contact lens worn on a daily wear basis and replaced monthly
16220704|NCT01233089|Device|Lotrafilcon B contact lens, commercial (AIR OPTIX AQUA)|Commercially available silicone hydrogel, spherical contact lens worn on a daily wear basis and replaced monthly.
16220705|NCT01233089|Device|Lotrafilcon B multifocal contact lens, commercial (AIR OPTIX AQUA MULTIFOCAL)|Commercially available silicone hydrogel, multifocal, contact lens worn on a daily wear basis and replaced monthly.
16220706|NCT01233089|Device|Contact lens care system (ClearCare)|Commercially available, hydrogen peroxide-based system for cleaning, disinfecting, and storing contact lenses
16220707|NCT01233076|Device|Nelfilcon A contact lens|Commercially marketed, spherical contact lens for daily wear, daily disposable use
16220708|NCT01233076|Device|Narafilcon B contact lens|Commercially marketed (US), spherical contact lens for daily wear, daily disposable use
16220709|NCT01233063|Behavioral|Physical Activity and Diet Intervention via Alive2|Weekly email/web goal-setting intervention to improve physical activity and diet, with and without additional phone and mail support.
16220710|NCT01233050|Drug|2% Chlorhexidine Gluconate/70% Isopropyl Alcohol|Preoperative skin antisepsis preparation
16220711|NCT01233050|Drug|Iodine Povacrylex/74% Isopropyl Alcohol|preoperative skin antisepsis preparation
16220712|NCT01233024|Dietary Supplement|Control|Dinner bar fortified with 0g fiber; breakfast bar fortified with 0g dietary fiber.
16220713|NCT01233024|Dietary Supplement|Soluble corn fiber|Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.
16220715|NCT01233024|Dietary Supplement|Fructooligosaccharide|Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.
16220716|NCT01233024|Dietary Supplement|Inulin|Dinner bar fortified with 12g fiber; breakfast bar fortified with 11g dietary fiber.
16220717|NCT01232985|Device|RD047-26|RD047-26 emollient gel
16220718|NCT01232972|Procedure|vitrification of oocytes|eggs will be preserved via vitrification the day they are retrieved from the participant
16220719|NCT01232959|Device|Transvaginal Cholecystectomy|A small incision is made in the vagina. An endoscope (flexible lighted camera tube) is inserted into the abdomen. An endoscope is normally used to examine your stomach or colon. A very small camera is placed in your abdomen at the belly button (5 mm, ¼ inch). This helps the surgeons to remove your gallbladder through the vagina. The procedure to separate your gallbladder from your body will be assisted by instruments placed through your abdomen and instruments placed in your vagina. The surgeon will remove the gallbladder by passing it though your vagina.
16220720|NCT01232946|Drug|liraglutide|1.8mg subcutaneous qd for 3 months
16220721|NCT01232946|Drug|insulin detemir|5units subcutaneous bid titrated to fasting glucose of <130mg/dL for 3 months
16220722|NCT01232946|Drug|liraglutide plus insulin detemir|liraglutide 1.8mg subq qd plus insulin detemir 5units bid titrated to fasting blood glucose <130mg/dL for 3 months.
16220723|NCT01232933|Device|VPS System|Use of the navigational VPS system during catheter placement
16220724|NCT01232920|Drug|Methotrexate|All methotrexate doses will be taken orally once per week in a divided dose (half in the morning, half in the evening), and should be taken with food. For the first two weeks, a loading dose of 15 mg/week orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 25 mg/week until the end of follow-up or until treatment failure due to intolerability, adverse events, or of lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 20 mg per week while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 15 mg per week.
16220725|NCT01232920|Drug|Mycophenolate mofetil|Mycophenolate mofetil will be taken twice daily on an empty stomach. For the first two weeks, a loading dose of 500 mg/BID orally will be administered to assess tolerability. After two weeks, the dose will be ramped up to 1 g/BID until the end of follow-up or until treatment failure due to intolerability, adverse events, or lack of efficacy. If the study ophthalmologist decides to reduce the study treatment dose due to intolerability, the dose will be reduced to 750 mg/BID while maintaining masking. If side effects persist and the study ophthalmologist wishes to reduce the dose a second time, the dose will be reduced to 500 mg/BID.
16220726|NCT01232907|Drug|L-Carnitine|L-Carnitine, a pharmaceutical product, for the treatment of fatigue in persons with spinal cord injury will be used for this study. L-Carnitine is a nutrient normally obtained in the fat from meat. It promotes fatty acid oxidation of muscle, thereby promoting efficient energy production. Treatment with L-Carnitine has been shown to produce clinically significant improvement in fatigue in persons with multiple sclerosis (MS), cancer, and in aging populations. While the causes of fatigue in persons with SCI may be multifactorial, successful use of L-Carnitine in MS-related fatigue suggests it may have a role in SCI. Standard treatment will entail daily dosages of 1980 milligrams of L-Carnitine (three 330 mg tablets in the morning and three 330 mg tablets in the evening) for 4 weeks.
16220727|NCT01232894|Drug|Indacaterol|Indacaterol 150 µg once-daily via single-dose dry powder inhaler
16220728|NCT01232894|Drug|Long-acting beta2-agonist|Long-acting beta2-agonist (LABA) bronchodilator monotherapy via inhaler twice daily
16220729|NCT01232881|Procedure|Tumor Sample|Tumor sample submission can consist of a fresh frozen tissue sample or a formalin-fixed paraffin embedded tissue block.
16220730|NCT01232881|Procedure|Serum Sample|Serum is to be collected prior to the initiation of lonafarnib treatment and 28 days after the last dose of lonafarnib.
16220731|NCT01232868|Biological|trivalent Influenza vaccine (TIV)|0.5 ml IM as a single dose in a prefilled syringe.
16220732|NCT01232855|Genetic|protein expression analysis|
16220733|NCT01232855|Genetic|western blotting|
16220734|NCT01232855|Other|flow cytometry|
16220735|NCT01232855|Other|laboratory biomarker analysis|
16220736|NCT01232842|Genetic|cytogenetic analysis|
16220737|NCT01232842|Other|HUMARA assay|
16220738|NCT01232842|Other|fluorescence activated cell sorting|
16220739|NCT01232842|Other|laboratory biomarker analysis|
16220740|NCT01232829|Drug|gamma-secretase/Notch signalling pathway inhibitor RO4929097|Given PO
16220741|NCT01232803|Drug|Tenofovir 1% gel|Entire contents of an applicator will be inserted rectally, for a total of 8 doses.
16220742|NCT01232803|Drug|2% N-9 gel|Entire contents of an applicator will be inserted rectally, for a total of 8 doses.
16220743|NCT01232803|Drug|HEC Placebo gel|Entire contents of an applicator will be inserted rectally, for a total of 8 doses.
16220744|NCT01232790|Dietary Supplement|N-Acetylcysteine|N-acetylcysteine 1200mg bid for 3 days
16220745|NCT01232790|Drug|Placebo|Placebo
16220746|NCT01232777|Drug|Bevacizumab|A single dosage of: 0.625mg(0.025cc)or 0.75mg(0.03cc) will be given intravitreally.
16220747|NCT01232764|Other|Exposure to multi-disciplinary wound care team|"Phase 1: In Person Support (3 mths)
~Advance Practice Nurses (APNs) affiliated with Enhanced Multi-Disciplinary visit LTC facilities on a weekly basis. The APN may communicate with other members of an EMDT via telephone or online.EMDTs will collectively teach and mentor LTC facility wound care teams throughout the study.
~Phase 2: Remote Support (2-11 mths) In the second phase, EMDTs will support LTC facility staff remotely via telephone and online communication, visiting the facilities on an as needed basis only.
~All PU treatment will be based on RNAO evidence-based guidelines (updated in 2007)contextualized to the LTC setting."
16220748|NCT01232751|Dietary Supplement|Isoflavone supplement|The participants will consume 2 times 2 supplements per day, which will lead to a daily dose of 114 mg. (HPLC analysis confirmed an aglycone isoflavone content of 28.41 mg per supplement)
16220749|NCT01232738|Drug|rasagiline|rasagiline 2 mg daily for 12 months
16220750|NCT01232725|Dietary Supplement|Donor Human Milk|Donor Human Milk, obtained from the Mother's Milk of Iowa, a HMBANA milk bank
16220875|NCT01231802|Drug|Eniluracil|Eniluracil (40 mg) orally at 18:00 ± 1 hour (6:00 PM) on Days 1, 8, & 15
16220876|NCT01231802|Drug|5-Fluorouracil|5-FU (30 mg/m2) orally at 7:00 AM ± 1 hour on Days 2, 9, & 16
16220751|NCT01232712|Biological|ImMucin, hGM-CSF|"Six biweekly Intradermal or subcutaneous injections of 100 micrograms ImMucin
~After six injections, if response will not be observed, or if response will not be sufficient, Immucin dose will be escalated to 250 micrograms for six additional injections.
~In addition, each immunization, hGM-CSF with a total dose of 250 microgram will be injected."
16220752|NCT01232699|Behavioral|Internet Obesity Treatment|Participants will engage in self monitoring, will receive skills training to help cope with environmental triggers, and will receive nutrition advice.
16220753|NCT01232699|Behavioral|Internet Obesity Treatment with MI|In addition to weekly group meetings, self-monitoring through recording calorie and fat intake daily as well as exercise, participants will meet one-on-one with an MI counselor on-line in order to augment an individual's motivation to change behavior.
16220754|NCT01232699|Behavioral|Contingent MI|Participants will attend weekly behavioral internet meetings. They may or may not receive Motivational Interviewing depending on their class attendance.
16220755|NCT01232686|Other|Online disease surveillance data access|In the intervention areas we will give the study participants online access to the Snow disease surveillance system. The system will provide data about the incidents of respiratory and gastrointestinal communicable diseases in the patient population.
16220756|NCT01232673|Procedure|BMAC application in Critical Limb Ischemia|Collection of 240ml from both illiac crests, followed by gradient density centrifugation, resulting in obtaining 40ml of BMAC (Bone-Marrow Aspiration Concentrate). BMAC is subsequently administered into the ischemic limb along calf vessels.
16220757|NCT01232660|Drug|Hydroxychloroquine|Hydroxychloroquine 400mg once daily orally
16220758|NCT01232647|Drug|Phylloquinone|1.0 mg daily of vitamin K1
16220759|NCT01232647|Drug|Menatetrenone (MK4)|Menatetrenone (MK4) 45 mg daily
16220760|NCT01232647|Drug|placebo|placebo vitamin K1 and placebo MK4 given daily for 18 months
16220761|NCT01232621|Other|Physician Introduction of research personnel|Physicians will introduce Research Coordinators (RCs) by name and acknowledge patient eligibility to participate in a research study using a standardized script.
16220762|NCT01232608|Behavioral|Exercise|12 months of exercise training
16220763|NCT01232595|Drug|LFF571|
16220764|NCT01232595|Drug|Vancomycin (POC)|
16220765|NCT01232582|Device|Exablate treatment|MR guided Focused Ultrasound treatment
16220766|NCT01232569|Drug|Tocilizumab 162 mg|Tocilizumab will be supplied in a ready-to-use, single-use, pre-filled syringe. Patients and/or caregivers will be trained to administer the injection.
16220767|NCT01232569|Drug|Placebo|Placebo will be supplied in a ready-to-use, single-use, pre-filled syringe. Patients and/or caregivers will be trained to administer the injection.
16220768|NCT01232556|Drug|Inotuzumab ozogamicin|1.8 mg/m2 on day 2 every 28 days by IV infusion, 3 to 6 cycles
16220769|NCT01232556|Drug|Rituximab|375 mg/m2 on day 1 every 28 days by IV infusion, 3 to 6 cycles
16220770|NCT01232556|Drug|rituximab + gemcitabine|rituximab 375 mg/m2 on days 1, 8, 15, and 22 of cycle 1, and day 1 of cycles 2 to 6, every 28 days by IV infusion, 3 to 6 cycles; gemcitabine 1000 mg/m2 on days 1, 8, and 15 every 28 days, 3 to 6 cycles
16220771|NCT01232556|Drug|rituximab +bendamustine|rituximab 375 mg/m2 on day 1 every 28 days by IV infusion, 3 to 6 cycles; bendamustine 120 mg/m2 on days 1 and 2 by IV infusion every 28 days, 3 to 6 cycles
16220772|NCT01232543|Drug|Product 0405|Product 0405 will be administered topically, twice daily for 28 days.
16220773|NCT01232504|Drug|rhGM-CSF group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
16220774|NCT01232504|Drug|rhG-CSF+rhGM-CSF group|a combination of 2-3μg/kg/d rhGM-CSF and 2-3μg/kg/d rhG-CSF each after transplantation, started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
16220775|NCT01232504|Drug|rhG-CSF group|subcutaneous rhGM-CSF 5-7μg/kg/d , started on day 5 post-transplant and continued until recovery from neutropenia (absolute neutrophil count [ANC] > 1.5×10(9)/L for 2 consecutive days).
16220776|NCT01232491|Drug|Insulin detemir|Individually adjusted insulin detemir subcutaneously (under the skin) once daily. Subjects continue their pre-trial metformin treatment.
16220777|NCT01232491|Dietary Supplement|Dietary regimen|Subjects receive dietary consultation by a dietician at six occasions during the trial.
16220778|NCT01232478|Behavioral|Comprehensive Adherence Program (CAP)|The Comprehensive Adherence Program (CAP) consists of training in the CF My Way program (a validated problem-solving adherence promotion intervention).
16220779|NCT01232452|Drug|Pemetrexed|Administered intravenously (IV)
16220780|NCT01232452|Drug|Cisplatin|Administered IV
16220781|NCT01232452|Drug|Cixutumumab|Administered IV
16220782|NCT01232439|Drug|opioid receptor kappa antagonist|"Starting dose of 2 mg, administered orally, once.
~The potential dose range for this study is 0.2 mg to 30 mg"
16220783|NCT01232426|Procedure|Biodegradable Meniscus Arrow®|Closed reduction of the Mallet fracture and fixation with 1 biodegradable meniscus Arrow®
16220784|NCT01232426|Device|Mallet splint|Conservative treatment of the Mallet fracture with the traditional Mallet splint.
16220785|NCT01232413|Drug|Placebo|Oral
16220786|NCT01232413|Drug|ASP1941|Oral
16220787|NCT01232413|Drug|Moxifloxacin|Oral
16220788|NCT01232400|Drug|Esmolol|"The initial esmolol infusion will be 50 mcg/kg/minute IV. This will be increased by 25 mcg/kg/minute every 15 minutes until one of the following situations is reached:
~Heart rate less than 70 bpm.
~Systolic blood pressure less than 120 mmHg
~Maximum dose of esmolol of 200 mcg/kg/minute is reached."
16220789|NCT01232374|Drug|Nimotuzumab|200mg (4 bottles), once a week for 7 weeks during irradiation (week 1, week 2, week 3, week 4, week 5, week 6 and week 7). After irradiation 200mg (4 bottles), once every 4 weeks for 2 cycles (week 9 and week 13)
16220790|NCT01232374|Drug|Placebo|4 bottles placebo, once a week for 7 weeks during irradiation (week 1, week 2, week 3, week 4, week 5, week 6 and week 7). After irradiation 200mg (4 bottles), once every 4 weeks for 2 cycles (week 9 and week 13)
16220791|NCT01232374|Drug|cisplatin|cisplatin 25 mg/m2/d, d1-3, once every 4 weeks for 4 cycles (week 1, week 5, week 9 and week 13); 5-FU 600 mg/m2/d, d1-3, continuously infusion for 72 hrs,once every 4 weeks for 4 cycles (week 1, week 5, week 9 and week 13).
16220977|NCT01231230|Drug|placebo inhalation|placebo inhalation once
16220792|NCT01232374|Radiation|Radiotherapy|"A total dose of 61.2 Gy will be delivered in 34 fractions at 1.8 Gy/fraction, 5 fractions per week in 6.8 weeks.
~Placebo: 4 bottles placebo, once a week for 7 weeks during irradiation (week 1, week 2, week 3, week 4, week 5, week 6 and week 7). After irradiation 200mg (4 bottles), once every 4 weeks for 2 cycles (week 9 and week 13)"
16220793|NCT01232309|Dietary Supplement|Chitin-Glucan|3 x 500 mg capsules (tid) = 4.5 mg daily dose
16220794|NCT01232309|Dietary Supplement|Low Dose Chitin-Glucan|3 x 167 mg capsules (tid) = 1.5 g daily dose
16220795|NCT01232309|Dietary Supplement|Low Dose Chitin-Glucan + Olive Extract|3 x 167 mg capsules (tid) = 1.5 g daily dose (C-G) + 135 mg olive extract
16220796|NCT01232309|Dietary Supplement|Placebo|3 x 500 mg capsules (tid)
16220797|NCT01232296|Drug|dovitinib|500 mg p.o. o.d. 5 days on/2 days off
16220798|NCT01232296|Drug|sorafenib|400 mg p.o. b.i.d.
16220799|NCT01232283|Drug|Apremilast|Apremilast 30mg by mouth (PO) twice a day (BID) for 32 weeks
16220800|NCT01232283|Drug|Placebo|Identically matching placebo by mouth BID for first 16 weeks. Placebo participants will be switched to receive apremilast 30 mg BID at Week 16-32.
16220801|NCT01232283|Other|Topical or Phototherapy Therapy|Topical therapies such as low-potency or weak corticosteroids or phototherapies such as light therapy are added for non-responders at Week 32, (< PASI-50) and added to their treatment regimen. The decision to add these treatments during this phase can only be made at the Week 32 visit.
16220802|NCT01232270|Drug|propofol|1.1 mcg/ml for initial effect site concentration during spinal anesthesia (The effect site concentration will be changed at each subject by Dixon's up-and-down method.)
16220803|NCT01232257|Drug|N-acetylcysteine|4 gifts of N-acetylcysteine 600 mg BID
16220804|NCT01232244|Other|GLP-1 infusion|1 pmol/kg/min
16220805|NCT01232244|Other|Glucagon infusion|3ng/kg/min
16220806|NCT01232244|Other|Oxyntomodulin infusion|3 pmol/kg/min
16220807|NCT01232244|Other|GLP-1 and glucagon infusion|1 pmol/kg/min 3 ng/kg/min
16220808|NCT01232244|Other|Placebo|NaCl 9 g/L infusion
16220809|NCT01232231|Drug|pharmacological decolonization treatment|Chlorhexidine gluconate 4% body scrub and 2% shampoo daily PLUS mupirocin 2%, fusidic acid 2%, or chlorhexidine gluconate 0.2% intranasally bid PLUS trimethoprim-sulfamethoxazole 160/800mg po bid or doxycycline 100mg po bid all for 7 days
16220810|NCT01232231|Behavioral|Education|No pharmacological decolonization treatment but given education regarding personal hygiene and environmental cleaning
16220811|NCT01232218|Other|Standard education/exercises for hemiplegic shoulder pain|Each participant will receive standard education for safe positioning and movement of the painful hemiplegic shoulder. Participants will also be provided with standard stretching and strengthening exercises by and experienced Occupational Therapist who will grade the level of exercise to suit their needs. Intervention will take place 3x/week for 1 hour.
16220812|NCT01232218|Other|Three dimensional Scapular-Humeral Mobilizations|Each participant will receive standard education for safe positioning and movement of the painful hemiplegic shoulder. Participants will also be provided with stretching and strengthening exercises by and experienced Occupational Therapist who will grade the level of exercise to suit their needs. Intervention will take place 3x/week for 1 hour. Participants in this group will receive an additional scapular humeral mobilization while simultaneously performing the standard stretching/strengthening exercise protocol.
16220813|NCT01232205|Dietary Supplement|micronutrient antioxidant|Supplementation with milk enriched with vitamin and mineral, such as Cu, Zn, Mn, Fe, carotene, vitamin B6, B12, C, E, selenium, and calcium
16220814|NCT01232205|Dietary Supplement|Control|supplementation with milk
16220815|NCT01232192|Behavioral|antenatal model|"Antenatal model is consisted of integrated efforts to lower preterm delivery rate through early detection and bacterial vaginal infection treatment:
~Midwife training
~Pregnant women campaigning
~Early detection with self pH detection
~Treatment of bacterial vaginosis"
16220816|NCT01232179|Procedure|conventional prp|pan retinal photocoagulation
16220817|NCT01232179|Procedure|targeted prp|1200-1600 spot in far periphery retin, anterior equator
16220818|NCT01232166|Other|Auscultation|
16220819|NCT01232166|Other|Observation of symmetric chest movements|
16220820|NCT01232166|Other|Tube depth|
16220821|NCT01232166|Other|All three|
16220822|NCT01232153|Device|Non invasive ventilation|Non invasive ventilation
16220823|NCT01232140|Other|CRP-guided antibiotic treatment|If CRP> 50 mg/l patients with AECOPD receive antibiotic treatment, whereas in those patients with CRP =< 50 mg/l antibiotic treatment are withheld. This will be compared to the regular antibiotic treatment that has been advised by the GOLD strategy
16220824|NCT01232127|Drug|Atazanavir|Capsule, oral, 300 mg, once daily, 10 days
16220825|NCT01232127|Drug|Atazanavir|Capsule, oral, 400 mg, once daily, 7 days
16220826|NCT01232127|Drug|Ritonavir|Capsule, oral, 100 mg, once daily, 10 days
16220827|NCT01232127|Drug|Ritonavir|Capsule, oral, 100 mg, once daily, 7 days
16220828|NCT01232127|Drug|Tenofovir (TDF)|Capsule, oral, 300 mg, once daily, 10 days
16220829|NCT01232127|Drug|Tenofovir (TDF)|Capsule, oral, 300 mg, once daily, 7 days
16220830|NCT01232127|Drug|Nucleoside Reverse Transcriptase Inhibitor (NRTI)|Oral, 10 days
16220831|NCT01232127|Drug|Nucleoside Reverse Transcriptase Inhibitor (NRTI)|Oral, 7 days
16220832|NCT01232127|Drug|Famotidine (FAM)|Tablet, oral, 20 mg, twice daily, 7 days
16220833|NCT01232127|Drug|Famotidine (FAM)|Tablet, oral, 40 mg, twice daily, 7 days
16220834|NCT01232101|Device|covered or uncovered stents|Patients are randomized to covered or uncovered stent. Stent patency is monitored and compared as well as complications, efficacy and technical success.
16220835|NCT01232075|Drug|Extended letrozole regimen|"Letrozole (Femara; Novartis pharma AG, Basle, Switzerland) 2.5mg /day is administered from cycle day 1 to 9 .
~Human chorionic gonadotropin (Pregnyl; N.V. Organon, Oss, Holland) ( 10.000 IU/I.M ) is administered to trigger ovulation when at least one follicle measures more than 18mm in mean diameter .Intrauterine insemination is performed 36 - 40 hours after HCG injection .
~Starting from cycle day 9 , ultrasound scans are repeated daily to monitor follicle growth . Serum estradiol and endometrial thickness are measured on the day of HCG administration.
~Serum B-subunit HCG is measured 2 weeks after IUI to diagnose pregnancy ."
16220877|NCT01231802|Drug|Leucovorin|Leucovorin (30 mg) orally at 7:00 AM ± 2 hours on Days 2, 3, 9, 10, 16, & 17
16220836|NCT01232075|Drug|Clomiphene citrate regimen|"Clomiphene citrate(Clomid; Aventis pharma S.AE, Global Napi pharmaceuticals, Cairo, Egypt) 100 mg/day is administered from cycle day 3 to 7.
~Human chorionic gonadotropin (Pregnyl; N.V. Organon, Oss, Holland) ( 10.000 IU/I.M ) is administered to trigger ovulation when at least one follicle measures more than 18mm in mean diameter .Intrauterine insemination is performed 36 - 40 hours after HCG injection .
~Starting from cycle day 9 , ultrasound scans are repeated daily to monitor follicle growth . Serum estradiol and endometrial thickness are measured on the day of HCG administration.
~Serum B-subunit HCG is measured 2 weeks after IUI to diagnose pregnancy ."
16220837|NCT01232049|Drug|Multiple Oral Dose of|Pitavastatin 4mg
16220838|NCT01232049|Drug|Multiple Oral Dose of|Valsartan 320mg
16220839|NCT01232036|Drug|Glucophage 500mg|Single Oral Dose of
16220840|NCT01232036|Drug|HL-018 500mg|Single Oral Dose of
16220841|NCT01232036|Other|No administration of Drug|
16220842|NCT01232023|Drug|Indobufen|Single Oral Dose of
16220843|NCT01232010|Drug|Mirodenafil|50mg Single Oral Dose of
16220844|NCT01231997|Drug|Udenafil|100mg Single Oral Dose of
16220845|NCT01231984|Device|4 mm x 32G Pen Needle|During the 12 week study period, subjects use this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects follow their usual insulin regimen and there is no upper limit on total daily insulin dosage or number of injections. Subjects are advised to inject straight in when using the 4mm PN, with no pinch up.
16220846|NCT01231984|Device|8mm x 31G Pen Needle|During the 12 week study period, subjects will use this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects follow their usual insulin regimen and there is no upper limit on total daily insulin dosage or number of injections. Subjects are directed to use pinch-up when injecting in the abdomen or thigh with the 8mm PN, and no pinch-up at other injection sites.
16220847|NCT01231984|Device|12.7mm x 29G Pen Needle|During the 12 week study period, subjects will use this pen needle with their own pen device for all daily insulin injections they usually administered themselves with a pen device. Subjects follow their usual insulin regimen and there is no upper limit on total daily insulin dosage or number of injections. When using the 12.7mm PN, subjects are instructed to insert either at an angle of 45 degrees, or to pinch up and hold the pen device at a 90 degree angle (straight in).
16220848|NCT01231971|Drug|Florbetapir|Participants will receive a single bolus intravenous injection of 10 mCi (370 MBq) (+/- 10%) florbetapir F18. At approximately 50-minutes post dose, scanning will begin. An approximately 20-minute image acquisition scan will be performed.
16220849|NCT01231971|Drug|Flortaucipir|Participants will receive a single bolus intravenous injection of 10 mCi (370 MBq) flortaucipir injection followed by a saline flush. At approximately 75-minutes post dose, scanning will begin. An approximately 30-minute image acquisition scan will be performed.
16220850|NCT01231958|Behavioral|The Heart Healthy Initiative for Hispanic Adults (HIP)|This randomized controlled pilot intervention study will include 150 Hispanic adults (45-75y) in the Greater Boston area. Participants will be randomized to either the intervention or control group after completing their baseline interview. The intervention group will receive 6 months of weekly group educational sessions, Zumba fitness classes and interactions with an embodied computer agent (ECA). The fitness classes and interactions with the ECA will continue for the second 6 months of the 1 year intervention. Intervention activities will occur at community centers in the greater Boston area. Control participants will receive standard of care for the first 6 months and will be offered the full intervention (weekly group educational sessions, Zumba fitness classes and interactions with the ECA) for the second 6 months of the study. Participants will complete an interview and blood draw at baseline, 6 months, and 12 months.
16220851|NCT01231919|Drug|Akt inhibitor MK2206|Given PO
16220852|NCT01231919|Other|diagnostic laboratory biomarker analysis|Correlative studies
16220853|NCT01231919|Other|pharmacological study|Correlative studies
16220854|NCT01231906|Drug|Cyclophosphamide|Given IV
16220855|NCT01231906|Drug|Dexrazoxane|
16220856|NCT01231906|Drug|Doxorubicin Hydrochloride|Given IV
16220857|NCT01231906|Drug|Etoposide|Given IV
16220858|NCT01231906|Drug|Ifosfamide|Given IV
16220859|NCT01231906|Other|Laboratory Biomarker Analysis|Correlative studies
16220860|NCT01231906|Drug|Topotecan Hydrochloride|Given IV
16220861|NCT01231906|Drug|Vincristine Sulfate|Given IV
16220862|NCT01231893|Procedure|olfactory mucosa ensheathing cell grafting, rehabilitation|In this group patients are planned to underwent a biopsy of their own olfactory mucosa for isolation and culture of olfactory ensheathing cells and olfactory fibroblasts. The suspension of these cells will be next transplanted into the focus of spinal cord injury. Before and after surgery the patients will undergo an intense neurorehabilitation program.
16220863|NCT01231893|Other|rehabilitation|In this group the patients will not undergo any surgical procedure. They will participate in the same rehabilitation protocol that is planned for the patients from the experimental group.
16220864|NCT01231880|Drug|Four monthly IPT with dihydroartemisinin Piperaquine (DP)|Given every 4 months (once a school term)
16220865|NCT01231880|Drug|Monthly IPT using DP|Given every month
16220866|NCT01231880|Drug|Placebo given every month|No active ingredient
16220867|NCT01231854|Drug|Ciclosporin|In accordance with the current guideline concerning the use of ciclosporin in dermatology and the current guideline management of hand eczema the daily oral dosage of ciclosporin microemulsion is 2.7 to 4.0 mg/kg bodyweight (half of the total daily dosage will be administered in the morning and in the evening). To enable both body-weight adjusted treatment and double-blind treatment patients will be allocated to 2 different dosages depending on their body weight (50-74.9 kg: daily dosage 200 mg; 75-100 kg: daily dosage 300 mg).
16220868|NCT01231854|Drug|Alitretinoin|In accordance with the current guideline management of hand eczema alitretinoin will be administered orally in a constant daily dosage of 30 mg.
16220869|NCT01231841|Drug|cyclosporine|Given orally
16220870|NCT01231841|Biological|anti-thymocyte globulin|Given IV
16220871|NCT01231828|Drug|L-carnitine|L-carnitine 4g per day (4 bottles of 10ml).
16220872|NCT01231828|Drug|Lactulose|Lactulose (30-60 ml per day)
16220873|NCT01231815|Radiation|15O-H2O PET -|Assessment of coronary reserve using PET
16220874|NCT01231815|Radiation|MRI|Assessment of coronary reserve using MRI
16220878|NCT01231802|Drug|Capecitabine|Capecitabine (1000 mg/m2) twice daily (12 hr apart) for 14 consecutive days followed by 7 days off-treatment
16220879|NCT01231789|Procedure|RIPC|RIPC consisted of three 5-min cycles of right upper arm ischemia, which was induced by an automated cuff-inflator placed on the right upper arm and inflated to 200 mmHg, with an intervening 5 min of reperfusion during which the cuff was deflated
16220880|NCT01231789|Procedure|sham RIPC|Patients had a deflated cuff placed on the right upper arm for 30 min without any inflation procedure.
16220881|NCT01231776|Other|electronic acupuncture|applying a stimula on neiguang and shenmen through electronic acupuncture
16220882|NCT01231763|Other|No intervention (not applicable)|No intervention (not applicable)
16220883|NCT01231750|Drug|Capsaicin|0.1% topical cream,4cm spread over 8cm x 15cm area on skin, one time, 45 minutes prior to exercise
16220884|NCT01231750|Other|Placebo cream|cream, 4cm spread over 8cm x 15cm area of skin
16220885|NCT01231737|Drug|prulifloxacin|Prulifloxacin 1 tablet/week for 12 weeks.
16220886|NCT01231724|Device|Allstate Nasal Spray|Allstate Nasal Spray, two sprays (total 100 microliters) in each nostril.
16220887|NCT01231724|Device|Placebo Nasal Spray|2 sprays in each nostril
16220888|NCT01231711|Behavioral|Vets Prevail|"The intervention has two primary components that are both delivered over the Internet:
~The first component is a structured series of brief peer-to-peer instant messaging Chats structured around ensuring effective motivation, engagement, and completion. This component was modeled after Motivational Interviewing (MI) techniques. The peer-to-peer contact was provided by a master's level social worker, as well as by trained and certified combat veterans who completed the Vet-to-Vet counseling certificate program offered by the Depression and Bipolar Support Alliance (DBSA).
~The second component consists of six 30-minute e-Learning Lessons using standard Cognitive Behavioral Therapy (CBT) approaches to reducing depressive and anxiety symptoms and strengthening coping skills."
16220889|NCT01231698|Drug|esmolol|Strict heart rate control: esmolol at any dose to maintain heart rate between 95 and 80 bpm.
16220890|NCT01231698|Other|control|standard treatment without strict heart rate control
16220891|NCT01231685|Drug|Raltegravir|Subjects will maintain their nucleoside backbone and switch ritonavir-boosted protease inhibitor to Raltegravir 400 mg po BID for 48 weeks.
16220892|NCT01231685|Drug|Ritonavir-boosted protease inhibitor|Subjects will maintain their nucleoside backbone and remain on a ritonavir-boosted protease inhibitor at standard doses for for 48 weeks
16220893|NCT01231672|Biological|Routine biological analyses|Bilirubinemia (total and conjugated), hematology, hemogram, SOFA score
16220894|NCT01231659|Drug|Everolimus|Everolimus 10 mg (2 tablets of 5 mg) once daily
16220895|NCT01231659|Drug|Letrozole|Letrozole 2.5 mg once daily
16220896|NCT01231646|Other|No intervention|No intervention. This is a cross-sectional study.
16220897|NCT01231633|Drug|Ozurdex|Ozurdex, 0.7mg dexamethasone
16220898|NCT01231633|Drug|Avastin|Formulated as a 1.25mg/0.05ml sterile solution given by intravitreal injection monthly as needed.
16220899|NCT01231620|Drug|Zanamivir|Zanamivir aqueous solution, 10 mg/mL, will be provided as a single use, sterile clear, colorless preparation in 20 mL clear glass vials.
16220900|NCT01231620|Drug|Placebo to match zanamivir|Placebo to match IV zanamivir will be provided as a normal saline solution of a matched volume.
16220901|NCT01231620|Drug|Oseltamivir|Oseltamivir will be provided as over-encapsulated 75 mg capsules.
16220902|NCT01231620|Drug|Placebo to match oseltamivir|Placebo to match oral oseltamivir will be provided as capsules with a common excipient of appropriate quality.
16220903|NCT01231607|Drug|1mg Finasteride active|1mg finasteride active, by mouth once daily
16220904|NCT01231607|Drug|0.02mg dutasteride|0.02mg dutasteride active, by mouth once daily
16220905|NCT01231607|Drug|0.1mg dutasteride|0.1mg dutasteride active, by mouth once daily
16220906|NCT01231607|Drug|0.5mg dutasteride|0.5mg dutasteride active, by mouth once daily
16220907|NCT01231607|Drug|Finasteride placebo|finasteride placebo, by mouth once daily
16220908|NCT01231607|Drug|Dutasteride placebo|dutasteride placebo, by mouth once daily
16220909|NCT01231594|Drug|GSK2118436|Study Drug
16220910|NCT01231594|Drug|GSK1120212|Study Drug
16220911|NCT01231594|Drug|Other approved anti-cancer agent|Study Drug
16220912|NCT01231581|Drug|GSK1120212|administered orally starting on day 1 followed by a continuous daily dosing of 2.0 mg
16220913|NCT01231581|Drug|Gemcitabine|Intravenous gemcitabine infused over 30 minutes weekly for 7 weeks followed by one week of rest from treatment. Subsequent cycles will consist of 1000 mg/m2 intravenous infusion over 30 minutes on days 1, 8, and 15 followed by 1 week of rest from treatment for each 28-day treatment period.
16220914|NCT01231581|Drug|Placebo|administered orally starting on day 1 followed by a continuous daily dosing of 2.0 mg
16220915|NCT01231568|Drug|Regimen A|Two gelatin capsules containing 75 mg GSK2118436A (dosed as the mesylate salt, micronized particles, equivalent to 150 mg free base), dosed fasted
16220916|NCT01231568|Drug|Regimen B|Two gelatin capsules containing 75 mg GSK2118436A (dosed as the mesylate salt, larger, non-micronized particles, equivalent to 150 mg free base), dosed fasted
16220917|NCT01231568|Drug|Regimen C|Two Hydroxy Propyl Methyl Cellulose (HPMC) capsules containing 75 mg GSK2118436A (dosed as the mesylate salt, micronized particles, equivalent to 150 mg free base), dosed fasted
16220918|NCT01231568|Drug|Regimen D|Two HPMC capsules containing 75 mg GSK2118436A (dosed as the mesylate salt, micronized particles, equivalent to 150 mg free base), dosed with a high-fat meal
16220919|NCT01231555|Drug|GSK2248761 100 mg once daily|1x100 mg capsule plus matching placebo
16220920|NCT01231555|Drug|GSK2248761 200 mg once daily|2x100 mg capsules
16220921|NCT01231555|Drug|Efavirenz 600 mg once daily|1x600mg tablet
16220922|NCT01231542|Drug|GSK1349572|GSK1349572 is an experimental drug for the treatment of HIV. GSK1349572 is in the integrase inhibitor class. It is not yet approved by the FDA.
16220923|NCT01231542|Drug|Rifampin|Rifampin is approved by the FDA for the treatment of tuberculosis.
16220924|NCT01231542|Drug|Rifabutin|Rifabutin is approved by the FDA for the treatment of tuberculosis.
16220925|NCT01231529|Drug|GSK1349572|All subjects will receive a single dose of GSK1349572 50 mg. GSK1349572 is an experimental drug in the integrase inhibitor class being developed for the treatment of HIV infection. GSK1349572 is not approved by the FDA.
16220930|NCT01231503|Biological|GSK Biological's Investigational Malaria Vaccine 257049|3 doses, intramuscular (IM) route, in left antero-lateral thigh, as follows: 1) RTS,S Neo-10-14 Group at less than (=<) 7 days, at 10 and 14 weeks (wks) of age; 2) RTS,S Neo-10-26 Group =< 7 days, at 10 and 26 wks of age; 3) RTS,S 6-10-14 Group at 6, 10 and 14 wks of age; 4) RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 5) Engerix-B Neo/RTS,S 6-10-26 Group at 6, 10 and 26 wks of age; 6) RTS,S 10-14-26 Group at 10, 14 and 26 wks of age; 7) RTS,S 14-26-9M Group at 14 and 26 wks of age and at 9 months of age
16220931|NCT01231503|Biological|Engerix-B|1 dose, intramuscular route: left antero-lateral thigh at birth (=< 7 days of age)
16220932|NCT01231503|Biological|Tritanrix HepB Hib|3 doses, intramuscular route: right antero-lateral thigh at 6, 10 and 14 weeks of age
16220933|NCT01231503|Biological|BCG|1 dose, intradermal route, in shoulder at birth (=< 7 days of age)
16220934|NCT01231503|Biological|OPV|4 doses, orally, at birth (=< 7 days of age) and at 6, 10 and 14 weeks of age
16220935|NCT01231503|Biological|Rouvax|1 dose, intramuscular (IM) route, in left antero-lateral thigh, at 9 months of age
16220936|NCT01231490|Drug|Placebo|Placebo
16220937|NCT01231490|Drug|Naproxen|Capsule
16220938|NCT01231464|Drug|fluticasone furoate nasal spray|fluticasone furoate nasal spray 110ug, once daily
16220939|NCT01231464|Drug|placebo|placebo
16220940|NCT01231451|Drug|DMPA|All subjects will take DMPA
16220941|NCT01231438|Drug|Renvela|800mg t.i.d. over 2 weeks
16220942|NCT01231438|Drug|Etalpha|0.25ug o.d. for 2 weeks
16220943|NCT01231412|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic PBSCT
16220944|NCT01231412|Drug|Cyclosporine|Given PO or IV
16220945|NCT01231412|Drug|Fludarabine Phosphate|Given IV
16220946|NCT01231412|Drug|Mycophenolate Mofetil|Given PO
16220947|NCT01231412|Procedure|Peripheral Blood Stem Cell Transplantation|Undergo allogeneic PBSCT
16220948|NCT01231412|Drug|Sirolimus|Given PO
16220949|NCT01231412|Radiation|Total-Body Irradiation|Undergo TBI
16220950|NCT01231399|Drug|fluorouracil|Given IV
16220951|NCT01231399|Drug|leucovorin calcium|Given IV
16220952|NCT01231399|Drug|oxaliplatin|Given IV
16220953|NCT01231399|Drug|everolimus|Given orally
16220954|NCT01231399|Other|laboratory biomarker analysis|Correlative studies
16220955|NCT01231399|Other|immunohistochemistry staining method|Correlative studies
16220956|NCT01231399|Genetic|microarray analysis|Correlative studies
16220957|NCT01231373|Drug|polidocanol injectable foam, 0.125%|active placebo for blinding
16220958|NCT01231373|Drug|polidocanol injectable foam, 0.5%|0.5% polidocanol foam injection
16220959|NCT01231373|Drug|polidocanol injectable foam, 1.0%|1.0% polidocanol foam injection
16220960|NCT01231373|Drug|Vehicle|injection of vehicle comparator
16220961|NCT01231360|Other|Exercise Training|Subjects randomized to exercise training will participate in a three-month treadmill exercise program in 1-hour training sessions three times per week as previously described. After a 5-minute warm-up period, exercise is initiated at a low workload of 2 mph at 0% grade. Subjects walk until moderate claudication severity develops, and then rest until the discomfort resolves, repeating until the total exercise period is completed. The intensity of the treadmill exercise is increased as tolerated by increasing walking speed by 0.5-1 mph and/or grade by 1-2%. Subjects are encouraged to continue the walking program at home for at least 30 minutes on two separate occasions each week.
16220962|NCT01231360|Other|Normal routine|Subjects randomized to the routine activity control group will be asked to keep a log of their daily activities and return to the Vascular Research Center at weeks 4, 8, and 12 at which time they will be asked to return their log and undergo repeat treadmill testing and complete the 6 minute walk test.
16220963|NCT01231347|Drug|AMG 479|AMG 479 12 mg/kg administered intravenously on days 1 and 15 of a 28 day cycle
16220964|NCT01231347|Drug|Placebo|Placebo administered intravenously on days 1 and 15 of a 28 day cycle
16220965|NCT01231347|Drug|AMG 479|AMG 479 20mg/kg administered intravenously on days 1 and 15 of a 28 day cycle
16220966|NCT01231347|Drug|gemcitabine|gemcitabine 1000mg/m2 administered intravenously on days 1, 8 and 15 of a 28 day cycle
16220967|NCT01231334|Drug|Dapsone plus Adapalene|Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks.
16220968|NCT01231334|Drug|Clindamycin/benzoyl peroxide plus Adapalene|Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks
16220969|NCT01231321|Drug|adalimumab|Adalimumab 40 mg in 0.8 ml in pre-filled syringe for under the skin of the abdomen or the thigh injection every other week.
16220970|NCT01231308|Procedure|Roux-en-Y-Gastric Bypass|Standard laparoscopic gastric bypass. Preoperative preparation will include antibiotic prophylaxis given less than 60 minutes prior to making the first incision. Under general anesthesia with endotracheal intubation, a laparoscopic gastric bypass will be performed in the usual fashion.
16220971|NCT01231308|Behavioral|Intensive lifestyle modification and Optimal medical Therapy|Very low calorie diet consisting of 5 feedings: 2 liquid meal replacements, 2 low-calorie snacks, and 1 small meal of known caloric content. After 10% weight loss is achieved, the subjects will received individualized nutrition sessions beginning bi-weekly but extending time intervals as the weight loss progresses.
16220972|NCT01231282|Other|diffusion-weighted MRI|MRI scan without contrast administration and without radiation exposure
16220973|NCT01231269|Other|MRI|MRI scan without administration of contrast/without radiation
16220974|NCT01231256|Behavioral|Preventive health consultation|A one hour preventive health consultation, based on completed baseline questionnaire, with one or two goal setting for a better life during the next year, with discussion and registration of resources, barriers, and time scheme. And a 3 month follow up consultation.
16220975|NCT01231243|Procedure|in-office bleaching with/without light|Two clinical sessions of tooth bleaching will be performed in each patient with a 1-week interval between them. In each session, three 15-min applications of the gel will be done using one of the two concentrations under investigation. In half of the sample of each concentration, the gel will be activated with a LED/laser device for a total of 3 min, as specified by the DMC manufacturer.
16220976|NCT01231230|Drug|fluticasone|220- mcg once
16220979|NCT01231230|Drug|fluticasone/salmeterol|inhalation of 250 mcg of fluticasone combined with 50 mcg of salmeterol
16220980|NCT01231217|Other|Green tea (Camellia sinensis)|Patients are recommended to drink at least 5 cups of green tea per day
16220981|NCT01231217|Other|Coffee|Patients are recommended to drink as much coffee as they tolerate.
16220982|NCT01231204|Procedure|Placebo (normal saline) Continuous Infusion|Patients randomized to this group will receive an initial catheter placement using the standard Ultrasound-guided Technique. For the surgical procedure they will receive 15cc of 0.5%Ropivicaine. Following the surgical procedure they will receive a pain pump filled with normal saline. The normal saline infusion will continue for the 3 days following surgery. All patients will have access to other pain relievers for break-through pain. All patients will have the outcome measures assessed.
16220983|NCT01231204|Procedure|Ropivicaine 0.4% Continuous Infusion|Patients randomized to this group will receive an initial catheter placement using the standard Ultrasound-guided Technique. For the surgical procedure they will receive 15cc of 0.5%Ropivicaine. Following the surgical procedure they will receive a pain pump filled with 0.4%Ropivicaine. The 0.4%Ropivicaine infusion will continue for the 3 days following surgery. All patients will have access to other pain relievers for break-through pain. All patients will have the outcome measures assessed.
16220984|NCT01231191|Drug|Intravenous acetaminophen|Acetaminophen 1000 mg administered over 15 minutes intravenously as soon as feasible intraoperatively.
16220985|NCT01231191|Drug|Intravenous placebo|Normal saline administered over 15 minutes intravenously as soon as feasible intraoperatively.
16220986|NCT01231178|Dietary Supplement|Alginate beverage|The dosage is 3x500ml daily
16220987|NCT01231178|Dietary Supplement|Control beverage|The dosage is 3x500ml daily
16220988|NCT01231165|Drug|Amiloride|5mg/daily for 12th months
16220989|NCT01231165|Drug|Nitrates, clopidogrel, aspirin, statins|Comparative Efficacious Research
16220990|NCT01231139|Drug|Paracetamol|Intravenous paracetamol, 1 gram (100mls), administered over 30 minutes (every 4 hours for 3 days).
16220991|NCT01231139|Drug|0.9% Sodium Chloride Schedule:|Identical placebo: 100mls saline given intravenous over 30 minutes (every 4 hours for 3 days)
16220992|NCT01231126|Drug|Misoprostol|Procedures were taken for induced labor delivery with misoprostol 25mcg, by vaginal rout. The pills were administered each 6 hours in a maximum number of six.
16220993|NCT01231113|Drug|artesunate-amodiaquine|The 452 pregnant women in this arm will receive artesunate-amodiaquine tablets(artesunate 4mg/kg and amodiaquine 10mg/kg in twelve hourly doses over 3 days
16220994|NCT01231113|Drug|Dihydroartemisinin-piperaquine|a fixed-dose combination to be administered to the other 452 pregnant women in this arm at an estimated total dosing of 6.75mg/kg dihydroartemisinin and 55mg/kg piperaquine over 3 days
16220995|NCT01231100|Other|HCUE-guided care|Care directed by hand-carried ultrasound echocardiography
16220996|NCT01231074|Drug|Metformin|Metformin dosing will be done as is typical in clinical practice. Doses will be titrated at 500mg daily for one week, to a maximum dose of 1000mg twice a day as tolerated by subject.
16220997|NCT01231061|Radiation|SBRT|•24 Gy in 3 fractions to cover at least 90% of the defined target volume
16220998|NCT01231061|Radiation|Radiosurgery|16 Gy in 1 fraction to cover at least 90% of the defined target volume
16220999|NCT01231009|Drug|Corticosteroids|Intravenous Dexamethasone, 8mg three times per day tapering down for 7 days Per os dexamethasone, 2mg per day tapering down for 7 days
16221000|NCT01231009|Other|Vestibular exercises|Vestibular exercises in order to enhance vestibulo-ocular reflex for 15 days under the suspicion of physiotherapist
16221001|NCT01230996|Drug|Cisplatin|Each patient will also receive chemotherapy with a drug called cisplatin, which is given intravenously through a drip in the arm once a week during their 6 week radiotherapy treatment. Again this is standard treatment for any patient with cervix cancer.
16221002|NCT01230996|Radiation|Intensity-modulated radiation therapy|Patients in this trial will receive radiotherapy to the pelvic area with additional chemotherapy (chemoradiotherapy). This is the standard treatment for cervix cancer and will be almost identical to patients not taking part in this study. As patients in the study will be treated with IMRT, the total radiation dose will be slightly higher but without increasing the dose to normal tissue in the pelvis. This will mean the number of radiotherapy treatments that each patient receives in the study is between 27 and 30 compared with the usual 28. Each patient will undergo 6 weeks of radiotherapy treatment and must attend the radiotherapy department hospital once daily (Monday to Friday) over 6 weeks. Each treatment lasts for approximately 10 15 minutes. This is exactly the same as standard practice if patients were not participating in the trial.
16221003|NCT01230996|Procedure|Intracavitary brachytherapy|Intracavitary brachytherapy Intracavitary brachytherapy will be given towards the end of external beam radiotherapy usually weeks five and six. This is routine treatment and will be given according to local practice As is the convention patients will be reviewed weekly (more frequently if necessary) by their study doctor and will have weekly blood tests to measure full blood count and urea and electrolytes.
16221004|NCT01230983|Drug|asparaginase|Given IV
16221005|NCT01230983|Drug|cytarabine|Given IV
16221006|NCT01230983|Drug|dexrazoxane hydrochloride|Given IV
16221007|NCT01230983|Drug|doxorubicin hydrochloride|Given IV
16221008|NCT01230983|Drug|leucovorin calcium|Given IV
16221009|NCT01230983|Drug|mercaptopurine|Given orally
16221010|NCT01230983|Drug|methotrexate|Given IV
16221011|NCT01230983|Drug|prednisone|Given orally
16221012|NCT01230983|Drug|therapeutic hydrocortisone|Given IT
16221013|NCT01230983|Drug|vincristine sulfate|Given IV
16221014|NCT01230983|Radiation|radiation therapy|Radiation to cranium
16221015|NCT01230970|Drug|BN83495|40mg tablet oral daily administration from Day 1 to Day 14.
16221016|NCT01230957|Biological|Clostridium difficile toxoids A and B (Low-dose with adjuvant)|0.5 mL, Intramuscular on Days 0, 7, and 30
16221017|NCT01230957|Biological|Clostridium difficile toxoids A and B (Low-dose without adjuvant)|0.5 mL, Intramuscular on Days 0, 7, and 30
16221018|NCT01230957|Biological|Clostridium difficile toxoids A and B (high-dose with adjuvant)|0.5 mL, Intramuscular on Days 0, 7, and 30
16221019|NCT01230957|Biological|Clostridium difficile toxoids A and B (high-dose without adjuvant)|0.5 mL, Intramuscular on Days 0, 7, and 30
16221020|NCT01230957|Biological|Placebo: 0.9% normal saline|0.5 mL, Intramuscular on Days 0, 7, and 30
16221021|NCT01230957|Biological|Clostridium difficile toxoids A and B (high-dose with adjuvant)|0.5 mL, Intramuscular on Days 0, 7, and 180
16221022|NCT01230957|Biological|Clostridium difficile toxoids A and B (high-dose with adjuvant)|0.5 mL, Intramuscular on Days 0, 30, and 180
16221023|NCT01230944|Procedure|Laparoscopic Nissen fundoplication|
16221024|NCT01230944|Procedure|Open Nissen fundoplication|
16221025|NCT01230931|Device|Vitagel|Vitagel (by Stryker) is a topical surgical hemostat spray that results in coagulation. The components are as follows: autogenous blood is drawn and centrifuged to produce a sample of platelets and growth factors; this is combined with a bovine thrombin and collagen solution. When the two are applied together, it produces the hemostatic effect.
16221026|NCT01230931|Procedure|Standard of care|Standard of care for hemostasis in acetabular surgery includes electrocautery/ligation of bleeding vessels, fracture reduction and stabilization, cell-saver, lap packing.
16221027|NCT01230918|Radiation|99mTc-NC100692|"HCM and ACS subjects: 99mTc-NC100692 SPECT scan, CMR and echocardiography images will be obtained and compared.
~Normal control: 99mTc-NC100692 SPECT scan, CMR and echocardiography imaging obtained for comparison with HCM and ACS images."
16221028|NCT01230905|Radiation|PET scan and ultrasound|Nuclear rest/stress testing of the heart using N-13-ammonia paired with brachial artery ultrasound
16221029|NCT01230892|Drug|Nebivolol|10 mg PO qday
16221030|NCT01230892|Drug|Atenolol|100 mg PO qday
16221031|NCT01230879|Other|EFR and TDM|EFR : Pulmonary function test TDM : tomodensitometry
16221034|NCT01230853|Drug|Active Comparator: A|Lecanemab Single Dose Ascending Single intravenous infusions at sequentially ascending doses on Day 1 (dose levels: 0.1, 0.3, 1, 3, 10, and 15 mg/kg)
16221035|NCT01230853|Drug|Placebo Comparator B|Placebo Matching Placebo Infusion
16221036|NCT01230853|Drug|Active Comparator B|Lecanemab Multiple Dose Ascending Intravenous infusions once every 4 weeks at sequentially ascending doses (dose levels: 0.3, 1, 3, and 10 mg/kg)
16221037|NCT01230853|Drug|Placebo Comparator A|Placebo Matching Placebo Infusion
16221038|NCT01230840|Dietary Supplement|wheat dextrin|5 grams of wheat dextrin baked in cookies will be taken 3 times a day for 2 weeks
16221039|NCT01230840|Dietary Supplement|placebo|cookies not containing wheat dextrin will be taken 3 times a day for 2 weeks
16221040|NCT01230827|Drug|CNTO 148 (Golimumab)|Patients will receive subcutaneous (SC) (under the skin) injection of golimumab 30 mg per square meter every 4 weeks from Week 0 through Week 248.
16221041|NCT01230827|Drug|Placebo|Patients who have a clinical response to golimumab at Week 16 and are randomly allocated to placebo, will receive SC injection of placebo every 4 weeks from Week 16 through Week 48.
16221042|NCT01230827|Drug|Methotrexate|All patients will receive their fixed dose of commercial methotrexate (10 to 30 mg per square meter) weekly throughout the study duration.
16221043|NCT01230814|Drug|Neo-Penotran® Forte (active ingredient Metronidazole & Miconazole Nitrate)|Neo-Penotran® Forte (active ingredient Metronidazole & Miconazole Nitrate), co-formulated vaginal suppositories containing metronidazole 750 mg with miconazole 200 mg and excipients (Witepsol S 55). Witepsol S 55 is a hard fat suppository base. Such bases consist mainly of triglyceride esters of the higher saturated fatty acids along with varying proportions of mono- and diglycerides. 117 subjects receive nightly for 5 consecutive night each month.
16221044|NCT01230814|Drug|Placebo|Placebo vaginal suppositories, identical in appearance to the active product; contains Witepsol S 55, Titanium Dioxide and D+C yellow #10 with no metronidazole or miconazole.117 subjects receive nightly for 5 consecutive nights each month.
16221045|NCT01230801|Biological|BMN 701|GILT-tagged recombinant human GAA
16221046|NCT01230788|Drug|rituximab|375 mg/m2/dose on days 8, 15, 22, and 29 (diluted in NS to a final concentration of 1 mg/ml for ease of administration). (Premedicate with Acetaminophen 15 mg/kg po (max 650 mg) and Diphenhydramine 1 mg/kg IV/PO (max 50 mg)).
16221047|NCT01230775|Drug|Anagrelide retard|"Week 1:
~1x1 tablet/d of Anagrelide retard (1 tablet = 2mg; total dose = 2mg/d) will be administered in week 1.
~Week 2 Anagrelide retard: Dosing will be titrated up according to response (platelet reduction) to 4 mg/day (=2x1 tablet) in week 2.
~Week 3 - Week 4 Anagrelide retard In week 3 and 4, dose will either be increased or decreased to maintain platelets in the normal or close to normal range. The maximum dose is 4 tablets (=8mg Anagrelide) per day.
~Maintenance Phase Anagrelide retard During maintenance phase (month 2 - month 12) doses of treatment are adjusted at the highest tolerated level which is able to maintain the platelet count within the normal range."
16221048|NCT01230775|Drug|Placebo|"Week 1:
~x1 tablet/d of placebo will be administered in week 1.
~Week 2
~Placebo:
~x1 tablet/d of placebo will be administered in week 2.
~Week 3 - Week 4
~Placebo:
~In week 3 and week 4 the maximum dose is 4 tablets per day.
~Placebo:
~In order to guarantee blinding of subjects the number of placebo tablets to be taken by the subject will vary during maintenance period:
~Month 2 - month 3: 2x1 tablet/d Month 3 - month 6: 3x1 tablet/d Month 6 - month 9: 4x1 tablet/d Month 9 - month 12: 4x1 tablet/"
16221049|NCT01230762|Drug|dapoxetine|60 mg tablet once daily as needed (prn) (with a possible dose reduction to 30 mg once daily) for up to 9 months
16221050|NCT01230749|Drug|JNJ-41443532|Participants will receive JNJ-41443532 tablet(s) orally in JNJ-41443532 250 mg arm (1 X 250 mg) and JNJ-41443532 1000 mg arm (4 X 250 mg) in morning and evening, for 28 days.
16221051|NCT01230749|Drug|Pioglitazone 30 mg|Participants will receive tablet pioglitazone 30 mg orally in morning for 28 days.
16221052|NCT01230749|Drug|Placebo|Participants will receive matching placebo tablets of JNJ-41443532 and/or matching placebo tablets of pioglitazone orally as per the assigned arms.
16221053|NCT01230736|Drug|Travoprost 0.004%/Timolol 0.5% Fixed Combination eye drops solution (Duotrav®)|One drop in study eye(s) once daily for 8 weeks
16221054|NCT01230723|Device|Everolimus-Eluting-Stent|due randomization everolimus-eluting-stent will be implanted
16221055|NCT01230723|Device|Zotarolimus-Eluting-Stent|due randomization zotarolimus-eluting-stent will be implanted
16221056|NCT01230710|Drug|Erlotinib|Erlotinib was supplied as tablets.
16221057|NCT01230697|Drug|Sorafenib|Sorafenib 800mg/die oral
16221093|NCT01230385|Drug|Lersivirine|Lersivirine 750 mg QD fasted (wet granulated tablet) for 21 days
16221058|NCT01230684|Procedure|Contrast Enhanced Ultrasound (Contrast Agent: OptisonTM)|The contrast agent will be prepared using a single, 3 mL vial of Optison and 57 mL saline combined in a sterile syringe. Contrast will be set to deliver a continuous infusion at 4 mL/min, via peripheral access. In the event that the above description of the administration of Optison is not adequate for lumen flow contrast enhancement the PI or Co-I will direct the study team to proceed to the secondary administration procedure. This will be done by the following: 0.5 mL of Optison will be injected into a peripheral vein. This may be repeated for further contrast enhancement as needed. The maximum total doses should not exceed 5.0 mL in any 10 minute period nor exceed 8.7 mL in any one patient study. We will follow the insert package dose. We will not not exceed 5.0 or 10 minutes or 8.7ml per patient (this will include the 0.5mL for initial). Therefore, no more that 8.2mL will given in this second administration procedure.
16221059|NCT01230671|Other|Yoga|A 12 week yoga session will be offered to women with breast cancer.
16221060|NCT01230645|Drug|RV568|RV568 400 ug administered as nasal drops twice daily for 10 days (Day -1 to Day 8)
16221061|NCT01230645|Drug|Placebo|Placebo administered as nasal drops twice daily for 10 days (Day -1 to Day 8)
16221062|NCT01230632|Dietary Supplement|high fat overfeeding|Dietary Supplement:3 days overfeeding
16221063|NCT01230619|Drug|RV568|RV568 400 ug administered as nasal drops twice daily on Day 1, RV568 800 ug administered as nasal drops once daily on Day 2
16221064|NCT01230619|Drug|Placebo|Placebo administered as nasal drops twice daily on Day 1, Placebo administered as nasal drops once daily on Day 2
16221065|NCT01230606|Other|discharge vs. overnight stay|At six hours post-PCI,patients will be randomized to be discharged immediately or to stay overnight in the hospital for observation and discharged the following day. Randomization will occur in a 1:1 ratio. Additionally, randomization will be performed stratified by study site.
16221066|NCT01230593|Drug|Hot Compress plus Tobramycin Drops and Ointment|In addition to hot compress, Tobramycin drops will be given to the affected eye 3x/day, and Tobramycin ointment will be given at night before bed.
16221067|NCT01230593|Drug|Hot compress plus Tobramycin/Dexamethasone Drops and Ointment|In addition to hot compress, Tobramycin/Dexamethasone drops will be given to the affected eye 3x/day, and Tobramycin/Dexamethasone ointment will be given at night before bed.
16221068|NCT01230593|Other|Hot Compresses|Hot compresses 3x/day to eyelids
16221069|NCT01230580|Drug|Protease Inhibitor|Switch to a regimen comprising a single ritonavir-boosted Protease Inhibitor
16221070|NCT01230580|Drug|Standard-of-care Antiretroviral therapy|Regimen should consist of 3 drugs: 2 nucleoside reverse transcriptase inhibitors with either a non-nucleoside reverse transcriptase inhibitor or a protease inhibitor
16221071|NCT01230554|Device|Daily disposable cosmetic tint lens|Bausch & Lomb daily disposable cosmetic tint contact lens worn on a daily disposable basis for 1 week.
16221072|NCT01230541|Drug|Placebo|Daily, oral tablet
16221073|NCT01230541|Drug|Udenafil|Daily tablet
16221074|NCT01230515|Other|Individual patient interview, focus group and structured survey|
16221075|NCT01230515|Other|interview, focus group and structured survey|
16221076|NCT01230515|Other|interview, focus group and structured survey|
16221077|NCT01230515|Other|interview, focus group and structured survey|
16221078|NCT01230502|Drug|Group 1 Donor Specific Regulation (DSR) +, Mycophenolic acid (MPA) monotherapy|"Group 1 Donor Specific Regulation (DSR) +, MPA monotherapy
~Mycophenolate sodium : Myfortic therapy will be maintained at a target dose of 720mg BID.
~Tacrolimus doses will be lowered to achieve levels of 3-5 ng/ml. 6 months later, immunological monitoring will be repeated and tacrolimus will be completely discontinued if the subject remains DSR + without development of donor specific antibodies (DSA). Those who become DSR- or develop DSA will remain on a tacrolimus dose achieving levels of 3-5 ng/ml, and will not undergone any additional reduction.
~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples."
16221079|NCT01230502|Other|data and sample collection|"Group 2 : Donor specific regulation (DSR) + standard of care:
~These subjects will be maintained on standard of care immunosuppression consisting of Tacrolimus and Mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment.
~Subjects will be followed for 24 months at 6 month intervals, and will provide health information and blood samples"
16221080|NCT01230502|Other|data and sample collection|"Group 3 : Donor specific regulation (DSR) - standard of care:
~These subjects are those who were DSR negative and/or DSA positive at enrollment and therefore are not eligible for the withdrawal aspect of the study. These subjects will be maintained on standard of care immunosuppression consisting of Tacrolimus and Mycophenolate sodium (MPS) with no reduction in tacrolimus dose during the 24 months of study enrollment. These subjects will be asked to provide heath information and donate blood, exclusively for research testing, at the same 6 month intervals as those in the other two arms of the study, and will be followed for 24 months."
16221081|NCT01230489|Biological|MediHoney|In this group a Medihoney 2 x 2 will be used in place of the standard dry 2 x 2 currently used as the wound dressing. Also all indentations of the wound will be filled with Medi-Honey ointment prior to the application of the dressing.
16221082|NCT01230476|Drug|Cetuximab|Cetuximab loading dose of 400mg/m2, then weekly dose of 250mg/m2 for 12 doses; Neoadjuvant Cisplatin 75mg/m2 D1, 5FU 1000mg/m2 D2-5, for 2 cycles; Concurrent Cisplatin 30mg/m2 given with radiation 70Gy/35fraction/7weeks.
16221083|NCT01230463|Drug|Ketorolac Tromethamine|15 mg ketorolac IV as a bolus 30 minutes before closure of surgery.
16221084|NCT01230463|Drug|Ketorolac Tromethamine|30 mg ketorolac IV as a bolus 30 minutes before closure of surgery.
16221085|NCT01230450|Procedure|sub-urethral tape (TVT-O)|Tension free vaginal tape vs. single incision sub-urethral tension free vaginal tape
16221086|NCT01230450|Other|stand standard mid-urethral sling (TVT-O)|
16221087|NCT01230424|Drug|Triamcinolone Acetonide|40 mg into the study knee joint every 12 weeks for a total of 8 injections.
16221088|NCT01230424|Drug|0.9% Sodium Chloride Injection as Placebo|Sodium chloride injection will be given into the study knee once every 12 weeks for a total of 8 injections.
16221089|NCT01230411|Other|saline placebo|250 cc of placebo administered IV
16221090|NCT01230411|Drug|Ibuprofen|800 mg ibuprofen in 250 cc saline administered IV
16221091|NCT01230385|Drug|Lersivirine|Lersivirine 500 mg QD fasted (wet granulated tablet) for 21 days
16221092|NCT01230385|Drug|Lersivirine|Lersivirine 500 mg QD fed (wet granulated tablet) for 21 days
16221094|NCT01230385|Drug|Lersivirine|Lersivirine 750 mg QD fed (wet granulated tablet) for 21 days
16221095|NCT01230385|Drug|Lersivirine|Lersivirine 500 mg QD fasted (dry granulated tablet) for 21 days
16221096|NCT01230359|Dietary Supplement|Pyridoxine hydrochloride|2.5 grams per day for subjects weighing upto 27 kilos and 5 g per day for greater than 27 kgs for 12 weeks
16221097|NCT01230359|Other|Tang orange powder|2.5 grams per day for subjects weighing upto 27 kilos and 5 g per day for greater than 27 kgs for 12 weeks
16221098|NCT01230346|Other|questionnaire administration|Ancillary studies
16221099|NCT01230346|Other|survey administration|Ancillary studies
16221100|NCT01230346|Other|counseling intervention|Telephone intervention
16221101|NCT01230346|Other|educational intervention|Telephone intervention
16221102|NCT01230320|Procedure|Denture fabrication technique|"Sequence of procedures involved with the fabrication of conventional complete dentures. Examples of common procedures are:
~the reproduction of denture-bearing tissues by means of impression techniques and casts;
~the registration of maxillo-mandibular relations;
~try-in of artificial teeth and carved denture bases."
16221103|NCT01230307|Drug|Vitamin D3|Vitamin D supplementation will be an oral load of 100,000 IU then 2000 IU by mouth daily of vitamin D3 (cholecalciferol)for 6 months
16221104|NCT01230307|Drug|Placebo|A placebo loading dose will be given followed by 2 placebo tablets daily for 6 months.
16221105|NCT01230281|Other|Black bean seed coat extract|1000 mg oral daily dose for 2 weeks
16221106|NCT01230268|Other|Mulberry fruit extract|1000 mg oral daily dose for 2 weeks
16221107|NCT01230255|Procedure|Percutaneous catheter drainage|Ultrasound guided insertion of a 14 French pigtail catheter to drain free intra-peritoneal fluid or blood and thereby reduce elevated intra-abdominal pressure
16221108|NCT01230242|Device|Levonorgestrel Intrauterine Device|levonorgestrel intrauterine device insertion within ten minutes of placental delivery using a ring forceps insertion protocol
16221109|NCT01230229|Procedure|Stenting|The stent should be deployed percutaneously, appropriate stent(s) size selected based upon the angiogram. The diameter must be 1-2 mm larger than the vessel. Length is chosen to cover lesion with one stent if possible. The choice of brand will be made through random selection among those offering possibility to cover the lesion with one stent. If more than one stent is required, overlap between 0.5 and 1 cm is acceptable. Postdilatation must be performed with a PTA balloon shorter than the length and less than the diameter of the stent. An angiogram should be made to compare the pre- and post-implant minimum lumen diameters. The non-diseased artery diameters shall be measured and residual % stenosis calculated.
16221110|NCT01230229|Other|Best medical treatment|Patients randomised to conservative treatment will receive appropriate medication with target levels of cholesterol 4,5 mmol/l, LDL 2,5 mmol/l and blood pressure level of 130/80 mmHg in addition to instruction how to engage in an exercise program. Each patient will receive a 'step-meter' which has to be carried during all activity during the first month and then during one week before each follow up visit. Step-meter read-outs will be recorded during each follow up visit. Smokers will be actively advised to quit smoking.
16221111|NCT01230216|Drug|control systolic blood pressure less than 120 mmHg|use losartan to control blood pressure
16221112|NCT01230216|Drug|control systolic blood pressure less than 140 mmHg|use losartan to control blood pressure
16221113|NCT01230203|Procedure|Computed tomography scan versus color duplex ultrasound|Computed tomography scan versus color duplex ultrasound
16221114|NCT01230190|Dietary Supplement|Ecologic ® Panda II|"Probiotic strains: 3 Bifidobacteria, 3 Lactococci, 1*10^9 Colony Forming Units/g.
~Composition: rice starch, maltodextrins, bacterial strains and mix of minerals."
16221115|NCT01230190|Dietary Supplement|placebo|rice starch, maltodextrins, and mix of minerals. The placebo mixture is similar in aspect, consistency and taste as Ecologic ® Panda II (intervention).
16221116|NCT01230177|Drug|etanercept (genetical recombination)|10 to 25 mg of etanercept (genetical recombination) reconstituted in 1 mL of water for injection (JP) administered twice weekly as a subcutaneous injection or 25 to 50 mg of etanercept (genetical recombination) administered once weekly as a subcutaneous injection, are usually the recommended dose for adults.
16221117|NCT01230151|Device|GUIDE software, Version 0.1|The GUIDE software uses computer-based models to determine the spread of stimulation from DBS therapy into surrounding nuclei of the brain. The software models stimulation and is not used to program or communicate with the patient's implanted DBS System. The software was recently validated in a multi-center clinical study.
16221118|NCT01230151|Device|Clinically defined stimulation parameters|Stimulation parameters clinically determined prior to start of clinical study
16221119|NCT01230138|Drug|Placebo|Placebo tablets
16221120|NCT01230138|Drug|FP187|High daily dose of 750mg administered as 250mg TID
16221121|NCT01230138|Drug|FP187|High daily dose of 750mg administered as 375mg BID
16221122|NCT01230138|Drug|FP187|Low daily dose of 500mg FP187 administered as 250mg BID
16221123|NCT01230138|Drug|FP187|Oral tablets, up to 3 times daily for 20 weeks.
16221124|NCT01230125|Drug|Mapracorat|Instill study medication into study eye per dosing instructions for 14 days
16221125|NCT01230125|Drug|Vehicle|Instill study medication into the study eye per dosing instructions for 14 days
16221126|NCT01230099|Behavioral|Supportive Information Team Group|A minimum of two protocolized, interdisciplinary, informational support meetings led by palliative care clinicians will be arranged with family members or other patient surrogates who participate in decision-making for individual chronically critically ill patients.
16221127|NCT01230086|Device|ICD Implantation without DFT testing|Implantation
16221128|NCT01230086|Device|Upper limit of vulnerability testing|Upper limit of vulnerability testing
16221129|NCT01230086|Device|T-wave shock with induction of ventricular fibrillation|Traditional safety margin testing for defibrillation threshold
16221130|NCT01230073|Device|Home-Monitoring|Home-Monitoring
16221131|NCT01230073|Device|Follow-up by Home-Monitoring|Follow-up by Home-Monitoring
16221132|NCT01230060|Device|enVista|One-piece hydrophobic acrylic intraocular lens (IOL) implanted following cataract extraction surgery. Patients to be followed for 120-180 days following surgery.
16221133|NCT01230047|Behavioral|Psychoeducational course|Psychoeducational course on mindfulness and lifestyle interventions for depression and anxiety
16221134|NCT01230034|Drug|Ramipril|pill, 5 and 10 mg/day, od, 24 weeks
16221135|NCT01230034|Drug|Imidapril|pill, 10 and 20 mg/day, od, 24 weeks
16221136|NCT01230021|Drug|catridecacog|Intravenous injection of a single dose of recombinant factor XIII, 35 IU/kg bodyweight
16221137|NCT01230008|Radiation|no drugs|Adjuvant radiotherapy 3.5 G will be administered or not (control group) in patients with mediastinal lymphoma,treated with R-CHOP
16221138|NCT01229995|Device|dental implants - zirconia abutmetns - prefabricated abutments|
16221139|NCT01229982|Drug|Latanoprost-PPDS|Punctal Plug
16221140|NCT01229969|Other|Wii Fit Balance Games|Ski Slaloms and Table Tilt
16221141|NCT01229969|Other|NeuroCom EquiTest® System|Sensory Organization Test (SOT) and Limit of Stability (LOS).
16221142|NCT01229956|Genetic|DNA methylation analysis|
16221143|NCT01229956|Genetic|gene expression analysis|
16221144|NCT01229956|Genetic|microarray analysis|
16221145|NCT01229956|Genetic|reverse transcriptase-polymerase chain reaction|
16221146|NCT01229956|Other|laboratory biomarker analysis|
16221147|NCT01229943|Biological|Bevacizumab|Given IV
16221148|NCT01229943|Drug|Everolimus|Given PO
16221149|NCT01229943|Drug|Octreotide Acetate|Given IM
16221150|NCT01229930|Drug|carboplatin|
16221151|NCT01229930|Drug|cediranib maleate|
16221152|NCT01229930|Drug|paclitaxel|
16221153|NCT01229930|Other|laboratory biomarker analysis|
16221154|NCT01229930|Other|pharmacological study|
16221155|NCT01229930|Procedure|quality-of-life assessment|
16221156|NCT01229917|Other|Fruit juice with Lactobacillus rhamnosus GG, version 1|
16221157|NCT01229917|Other|Fruit juice with Lactobacillus rhamnosus GG, version 2|
16221158|NCT01229917|Other|Standard fruit juice|
16221159|NCT01229904|Behavioral|music therapy with guitar lessons|The treatment is a 6 week music therapy intervention. Subjects receive 1 hour individual lesson and a 1 hour group session weekly for 6 weeks. they are given a guitar following completion of the study
16221160|NCT01229891|Dietary Supplement|plain yogurt drink|daily intake of two bottle of plain yogurt drink
16221161|NCT01229891|Dietary Supplement|vitamin D fortified yogurt drink|daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D/250 mL
16221162|NCT01229891|Dietary Supplement|vitamin D-calcium yogurt drink|daily intake of two bottle of yogurt drink fortified with 500 IU vitamin D and 250 mg calcium/250 ml package
16221163|NCT01229878|Dietary Supplement|Cholecalciferol (Vitamin D)|50,000 units of cholecalciferol or a placebo pill administered once a week for 6 months
16221164|NCT01229865|Drug|VB-111|
16221165|NCT01229852|Device|DSF-rTMS|Effective Transcranial Magnetic Stimulation
16221166|NCT01229839|Other|Embolization|embolization with lipiodol and polyvinyl alcohol particles (PVA)
16221167|NCT01229839|Other|Infusion of anticancer agent|infusion with chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg ) desolved in water
16221168|NCT01229839|Other|Infusion of mixture of anticancer agent and lipiodol|infusion of mixture of lipiodol and chemotherapy drugs (EADM 50mg, lobaplatin 50mg, and MMC 6mg)dissolved in water-soluble contrast medium and distilled water
16221169|NCT01229826|Radiation|MR Elastography|MRE is performed at the end of the examination after the standard MRI protocol. A test vibration is first applied on the patient to familiarize the patient with the vibration. The MRE sequence is performed with either a body coil or a pelvic-array coil. The total acquisition time is split into four periods of suspended respiration of 16 seconds for acquisition of wave images at four phase offsets. To obtain a consistent position of the fibroid for each phase offset, patients are asked to quietly breath and remain still.
16221170|NCT01229813|Drug|bevacizumab, erlotinib|bevacizumab 7.5 mg/kg body weight every third week, erlotinib 150 mg daily
16221171|NCT01229813|Drug|bevacizumab|bevacizumab 7.5 mg/kg body weight every third week
16221172|NCT01229813|Drug|bevacizumab|bevacizumab 7.5 mg/kg body weight every third week.
16221173|NCT01229813|Drug|low dose capecitabine|capecitabine 500 mg twice daily
16221174|NCT01229800|Drug|Polyethylene glycol|Group 1 (split-dose PEG regimen; Colyte, Taejoon Pharmaceuticals, Seoul, Korea; 236g PEG, 22.74g Na2SO4, 6.74g NaHCO3, 5.86g NaCl, and 2.97g KCl) ingested 2 liters of PEG at 6 PM on the day before the procedure and the remaining 2 liters in the early morning at least 2 hours prior to the procedure. Patients were instructed to take PEG 250 ml every ten minutes. Group 2 (NaP regimen; Solin Oral, Korea Pharma., Seoul, Korea; 48g NaH2PO4 monosodium phosphate, 18g Na2HPO4 disodium phosphate) ingested 45ml NaP solution at 6 PM on the day before the procedure and remaining 45ml of NaP solution, separated temporally by minimum of 10 to 12 hours, at least 2 hours prior to the colonoscopy on the day of the procedure.
16221175|NCT01229800|Drug|Sodium phosphate(NaP) solution|Group 2 (NaP regimen; Solin Oral, Korea Pharma., Seoul, Korea; 48g NaH2PO4 monosodium phosphate, 18g Na2HPO4 disodium phosphate) ingested 45ml NaP solution at 6 PM on the day before the procedure and remaining 45ml of NaP solution, separated temporally by minimum of 10 to 12 hours, at least 2 hours prior to the colonoscopy on the day of the procedure. Patients taking NaP solution were instructed to drink a minimum 1L of clear liquids during the evening on the day before the procedure and were encouraged to consume additional clear liquids.
16221176|NCT01229774|Drug|Etoricoxib|Arcoxia 90 mg once a day in the evening day -1 and 0 and once a day in the morning days 1-7 plus on tablett of placebo every evening
16221177|NCT01229774|Drug|Diclofenac|Voltaren Resinat 75mg once a day on day -1 and 0 in the evening; twice a day (in the morning and in the evening) days 1-7
16221178|NCT01229761|Drug|cotrimoxazole prophylaxis|100mg/20mg per day (or 2.5 mL of syrup from a 200mg/40mg per 5mL suspension) from 1-6 months, followed by 200mg/40mg per day (or 5 mL of syrup from a 200mg/40mg per 5 mL suspension) from 6 to 12 months
16221179|NCT01229761|Drug|cotrimoxazole placebo|100mg/20mg per day (or 2.5 mL of syrup from a 200mg/40mg per 5mL suspension) from 1-6 months, followed by 200mg/40mg per day (or 5 mL of syrup from a 200mg/40mg per 5 mL suspension) from 6 to 12 months
16221180|NCT01229761|Behavioral|exclusive breastfeeding until 6 months of age|Breastfeeding for 6 months, followed by formula feeding for 6 month. Breastfeeding infants will be prophylaxed with maternal highly active antiretroviral therapy (HAART) (if available) or with infant nevirapine.
16221181|NCT01229761|Behavioral|breastfeeding for 12 months|Breastfeeding infants will be prophylaxed with maternal HAART (if available) or with infant nevirapine.
16221272|NCT01229111|Drug|cediranib maleate|Given PO
16221182|NCT01229748|Behavioral|Standard Care|Clients attend two 90-minute group sessions per week.Treatment lasts for three months.
16221183|NCT01229748|Behavioral|Multidimensional Family Therapy|Multidimensional Family Therapy is an outpatient family-based treatment for troubled youth (Liddle, 2002). Treatment duration is 3 months, sessions last 60-90 minutes, with an average of 2 sessions per week and additional extrafamilial work and phone contacts as needed.
16221184|NCT01229748|Behavioral|Family Motivational Interviewing Intervention|Youth and parents receive 2 FMII sessions in their homes within 72 hours of the ER incident, and youth will be linked with group treatment lasting 3 months.
16221185|NCT01229735|Drug|Levetiracetam|250 mg and 500 mg levetiracetam tablet 1000 mg/day (500 mg bid) levetiracetam (maximum to 3000 mg/day) Duration: maximum 52 weeks
16221186|NCT01229735|Drug|Topiramate|25 mg and 100 mg topiramate tablet 100 mg/day(50 mg bid) topiramate (maximum to 400 mg/day) Duration: maximum 52 weeks
16221187|NCT01229722|Device|Beeper|Beepers are handheld portable devices which can be attached to a belt. At regular intervals corresponding to the participant's preferred reminder time, they buzz for a few minutes or until the participant presses a button to stop the buzzing.
16221188|NCT01229722|Device|ARemind|ARemind will personalize reminder messages based on adherence levels and facilitate patient phone calls with social workers/adherence counselors when appropriate. It will also consist of a text-messaging or interactive voice response (IVR) or phone-based pill count remote adherence assessment module.
16221189|NCT01229709|Behavioral|Mindfulness Based Tinnitus Reduction|The Mindfulness Based Tinnitus Reduction (MBTR) program will be held for two-and-a-half hours one evening per week over 8 consecutive weeks. Participants will also complete a day-long Sunday retreat between the 6th and 7th sessions. Each participant will take part in a 30-minute private interview with the course instructor prior to beginning the program.
16221190|NCT01229696|Procedure|Catheter Placed At Bifurcation|Patients randomized to this group will receive a sciatic nerve block placed at the bifurcaton of the sciatic nerve and outcome measures will be tested.
16221191|NCT01229696|Procedure|Catheter Placed 5cm Above Bifurcation|Patients randomized to this group will receive a sciatic nerve block placed 5cm above the bifurcaton of the sciatic nerve and outcome measures will be tested.
16221192|NCT01229683|Procedure|Interscalene Nerve Block|Patients undergoing shoulder surgery will be given an Interscalene Nerve Block. The patients' strength and sensation in their hand and forearm will be tested to determine if the nerve block is affectively delivering anesthetic to the nerves that serve these areas.
16221193|NCT01229670|Other|exercise|"1.exercise(Aerobic interval training (AIT)): training with 90% of VO2 peak and 40% of VO2 peak cycle for total 30 minutes exercise time
~2.exercise(moderate continuous training (MCT)):training with 60% of VO2peak for 30 min"
16221194|NCT01229644|Drug|Crenolanib (CP-868,596)|Highly potent inhibitor of both PDGFR receptors alpha and beta
16221195|NCT01229631|Dietary Supplement|Juice plus+|Subjects in active group will be supplemented with Juice plus+ capsules (3 in the morning and 3 in the evening, for 3 months)
16221196|NCT01229631|Dietary Supplement|Placebo non active capsules|Subjects will take non-active placebo capsules (3 in the morning and 3 in the evening, for 3 months)
16221197|NCT01229618|Drug|Hyperpolarized Pyruvate (13C) injection|single hyperpolarized pyruvate IV (intravenous) injection followed by MR imaging scans (MRI and MRSI)
16221198|NCT01229605|Drug|Cyclophosphamide and docetaxel|Cyclophosphamide and docetaxel every 3 weeks as neoadjuvant chemotherapy
16221199|NCT01229592|Drug|Ethanol|Every three day lock using Ethanol(70%)in all the lumen(1ml/per lumen) of the Catheter
16221200|NCT01229592|Drug|Heparine|Every three day lock using Heparin(Fibrilin TM) 3ml in all the lumen of the Catheter
16221201|NCT01229579|Drug|Zinc Sulfate|2.5 ml Zinc supplement syrup daily containing 10 mg of elemental zinc from day 14 to 18 weeks of age.
16221202|NCT01229579|Other|Placebo|2.5 ml placebo syrup daily with containing no elemental zinc from day 14 to 18 weeks of age.
16221203|NCT01229566|Drug|AKR-963|3600mg/day in capsules of AKR-963, Placebo, or Active Comparator
16221204|NCT01229553|Drug|decolonization|The decolonization protocol for the patients will consist of two-week course of cephalexin (100 mg/kg/day divided TID) or oral T/S (20 mg/kg/day divided BID), HBW every other day for 2 weeks, and mupirocin ointment into both nares BID for 2 weeks.
16221205|NCT01229540|Genetic|genetic analyzer|
16221206|NCT01229527|Drug|Remifentanil|Patient receive a bolus of Remifentanil (0,5 mcg/Kg) before the procedure and the PCSA pump is set to inject further bolus doses of 0,5 mcg/Kg every time the patient presses its button.
16221207|NCT01229527|Drug|Remifentanil|Patient receive a bolus of Remifentanil (0,8 mcg/Kg) before the procedure and the PCSA pump is set to inject further bolus doses of 0,8 mcg/Kg every time the patient presses its button.
16221208|NCT01229527|Drug|Meperidine|Patient receive a bolus of Meperidine (0,7 mg/Kg) before the procedure and the PCSA pump with saline (sham PCSA) is connected.
16221209|NCT01229514|Other|fMRI|fMRI and a response inhibition task to examine activation patterns in the prefrontal cortex and caudate nucleus
16221210|NCT01229488|Device|Intervention|Project was withdrawn before starting. There were no interventions
16221211|NCT01229475|Procedure|Ablation with stepwise approach|Stepwise approach for repeat AF ablation
16221212|NCT01229475|Procedure|Linear ablation|Linear ablation for AF ablation
16221213|NCT01229462|Drug|brimonidine tartrate/timolol fixed combination ophthalmic solution|One drop of brimonidine tartrate/timolol fixed combination ophthalmic solution (Combigan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.
16221214|NCT01229462|Drug|brimonidine tartrate ophthalmic solution|One drop of brimonidine tartrate ophthalmic solution (Alphagan®) administered to the affected eye(s) twice daily (morning and evening) for four weeks.
16221215|NCT01229462|Drug|timolol ophthalmic solution|One drop of timolol ophthalmic solution administered to the affected eye(s) twice daily (morning and evening) for four weeks.
16221216|NCT01229462|Other|fixed combination vehicle|Fixed combination vehicle administered to the affected eye(s) twice daily (morning and evening) for four weeks.
16221217|NCT01229449|Drug|Ibuprofen/acetaminophen|One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet, single dose taken orally with 300 ml water
16221218|NCT01229449|Drug|Ibuprofen/acetaminophen (higher dose)|Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg, single dose taken orally with 300 ml water
16221273|NCT01229111|Drug|oxaliplatin|Given IV
16221219|NCT01229449|Drug|Nurofen Plus®|Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®), single dose taken orally with 300 ml water
16221220|NCT01229449|Drug|Panadeine® Extra|Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra), single dose taken orally with 300 ml water
16221221|NCT01229449|Drug|Placebo|Two placebo tablets, single dose taken orally with 300 ml water
16221222|NCT01229436|Drug|Xiapex|Xiapex 0.58 mg in diluent, 0.25 ml for MP joints and 0.20 ml for PIP joints, injection to cord over joint using either 26 or 27 gauge needle, maximum 3 injections with 30 days interval between injections to any single site, maximum 5 injections in this protocol
16221223|NCT01229423|Drug|bimatoprost 0.03%|One drop of bimatoprost 0.03% (LATISSE®) applied evenly to each upper eyelid in the evening. Treatment is once daily for up to 40 weeks.
16221224|NCT01229410|Drug|400 µg Brimonidine Tartrate Implant|400 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
16221225|NCT01229410|Drug|200 µg Brimonidine Tartrate Implant|200 µg brimonidine tartrate implant in the study eye on Day 1 (2, 4 or 8 weeks prior to undergoing a pars plana vitrectomy).
16221226|NCT01229397|Biological|Inflexal V|vaccination with Inflexal V 0.25 mL administered twice, 4 weeks apart
16221227|NCT01229397|Biological|Inflexal V|Inflexal V 0.5 mL administrated once only
16221228|NCT01229384|Device|Positive Airway Pressure nebulization|Using a device approved in pediatrics to deliver nebulized treatments of albuterol and racemic epinephrine with positive pressure
16221229|NCT01229384|Device|Standard passive nebulization of respiratory medications|Patients will receive standard passively inhaled nebulized albuterol and racemic epinephrine.
16221230|NCT01229371|Biological|Inflexal V influenza vaccine (CSL HA Antigen) 2010|Inflexal V influenza vaccine (surface antigen, inactivated, virosome, using CSL HA Antigen) 2010/2011, with intramuscular administration, containing per 0.5 mL dose: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 μg HA antigen of B/Brisbane/60/2008-like virus
16221231|NCT01229371|Biological|Inflexal V influenza vaccine (AdImmune HA antigen) 2010/2011|Inflexal V influenza vaccine (surface antigen, inactivated, virosome, using AdImmune HA antigen) 2010/2011 with intramuscular administration, containing per 0.5 mL dose: 15 μg HA antigen of A/California/7/2009 (H1N1)-like virus; 15 μg HA antigen of A/Perth/16/2009 (H3N2)-like virus; 15 μg HA antigen of B/Brisbane/60/2008-like virus
16221232|NCT01229358|Other|Surgical dressing|Acticoat Absorbant™ vs standard dry gauze as the immediate post operative dressing
16221233|NCT01229345|Drug|Breakfast & exercise|1859 kJ breakfast vs fast, exercise at 60% maximum aerobic capacity to expend 1859 kJ.
16221234|NCT01229332|Drug|Saline|Continuous 24 h administration
16221235|NCT01229332|Drug|Carbidopa|Continuous 24 h administration
16221236|NCT01229319|Drug|Cryotherapy alone to Left arm plus cryotherapy + imiquimod to Right arm|Cryotherapy alone to Left arm plus cryotherapy + imiquimod 3.75% daily x 2 weeks on and 2 weeks off and 2 weeks on to Right arm
16221237|NCT01229319|Drug|Cryotherapy alone to Left arm plus cryotherapy + imiquimod to Right arm|Cryotherapy alone to Left arm plus cryotherapy + imiquimod 3.75% daily x 2 weeks on and 2 weeks off and 2 weeks on to Right arm
16221238|NCT01229306|Procedure|Ablation|Ablation of atrial fibrillation
16221239|NCT01229293|Procedure|Articular Surface Replacement (ASR)|Articular surface replacement, DePuy, posterolateral approach used
16221240|NCT01229293|Procedure|Standard Total Hip Arthroplasty (THA)|Device: Biomet 28mm
16221241|NCT01229280|Drug|Darifenacin|Single dose 7.5 mg tablets of darifenacin
16221242|NCT01229280|Drug|Darifenacin|Single dose 7.5 mg tablets of Darifenacin
16221243|NCT01229267|Biological|V212|V212 viral antigen for HZ. Participants will receive consistency Lot 1, 2, or 3 or the High Antigen Lot.
16221244|NCT01229267|Biological|Matching placebo|Vaccine stabilizer for V212 with no virus antigen
16221245|NCT01229254|Drug|Amiodarone|Patients on Amiodarone
16221246|NCT01229254|Drug|Betrixaban 60 mg|Betrixaban 60 mg once a day with food on Day 0 through Day 25
16221247|NCT01229254|Drug|Betrixaban 90 mg|Betrixaban 90 mg once a day with food on Day 0 through Day 25
16221248|NCT01229254|Drug|Betrixaban 30 mg|Betrixaban 30 mg once a day with food on Day 0 through Day 25 with concomitant amiodarone treatment.
16221249|NCT01229241|Drug|local anesthetic|"postoperative 48h epidural continuous infusion,
~ropivacaine 0,2% (250ml)+ sufentanil 0,75mcg/ml
~levobupivacaine 0,125% (250ml)+ sufentanil 0,75mcg/ml"
16221250|NCT01229228|Drug|Naproxen Test|200-mg single dose
16221251|NCT01229228|Drug|Naproxen Test|400-mg (2 x 200-mg)
16221252|NCT01229228|Drug|Naprosyn|single dose
16221253|NCT01229228|Drug|Naprosyn|single dose
16221254|NCT01229228|Drug|Placebo|single dose
16221255|NCT01229215|Drug|FCFD4514S|Repeating intravitreal injection
16221256|NCT01229215|Drug|sham|Repeating sham injection
16221257|NCT01229202|Drug|Bevacizumab|single bevacizumab subtenon injection of 1.25 mg. at end of trabeculectomy surgery
16221258|NCT01229189|Dietary Supplement|Vitamin D|Maternal dose of 4000 IU daily for 20 weeks Neonatal dose of 400 IU daily for 24 weeks
16221259|NCT01229189|Dietary Supplement|Placebo|Placebo will be supplemented to pregnant women and their neonates in the same pattern as in intervention group.
16221260|NCT01229176|Biological|Vi-CRM197 vaccine|
16221261|NCT01229176|Biological|Vi Polysaccharide (PS) vaccine|
16221262|NCT01229176|Biological|Pneumococcal conjugate vaccine|
16221263|NCT01229163|Device|Automated Contingency Management (ACM) software|
16221264|NCT01229150|Drug|AZD6244|For KRAS mutant patients randomized to the single agent arm, AZD6244 75 mg bid (twice a day).
16221265|NCT01229150|Drug|Erlotinib|For Wild-Type KRAS patients randomized to the single agent arm, Erlotinib 150 mg qd (every day)
16221266|NCT01229150|Drug|AZD6244 + Erlotinib|For KRAS mutant patients and Wild-Type KRAS patients randomized to the combination arm (arms are stratified based on KRAS mutational status), AZD6244 150 mg qd (every day) + erl (erlotinib) mg qd.
16221267|NCT01229137|Device|SRD-1 conversion|
16221268|NCT01229124|Genetic|RNA analysis|
16221269|NCT01229124|Genetic|nucleic acid sequencing|
16221270|NCT01229124|Genetic|reverse transcriptase-polymerase chain reaction|
16221271|NCT01229124|Other|laboratory biomarker analysis|
16221274|NCT01229111|Drug|leucovorin calcium|Given IV
16221275|NCT01229111|Drug|fluorouracil|Given IV
16221276|NCT01229098|Drug|LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension)|LEO 80185 (Taclonex® Scalp topical suspension/Xamiol® gel) Topical suspension applied once daily for up to 8 weeks
16221277|NCT01229085|Drug|memotasone + salicylic acid|mometasone 0,1% + salicylic acid 5%.
16221278|NCT01229072|Biological|Heparin sodic|Heparin sodic 150UI/kg
16221279|NCT01229072|Biological|heparin liquemine|Heparin sodic 150UI/kg
16221280|NCT01229059|Dietary Supplement|Lipovenös lipid infusion|Lipid enriched infusions will be applied for 2-6 hours.
16221281|NCT01229046|Drug|Ticarcillin-clavulanic acid|5 doses of IV ticarcillin-clavulanate infants < 14 days PNA will receive 75 mg/kg Q12 infants ≥ 14 days PNA will receive 75 mg/kg Q8
16221282|NCT01229033|Procedure|Ablation|Ablation of atrial tachycardia
16221283|NCT01229033|Procedure|Cardioversion|Cardioversion of atrial tachycardia
16221284|NCT01229020|Other|Observational study - no intervention|Observational study - no intervention. Patients underwent VRI recordings and routine V/Q scan.
16221285|NCT01229007|Biological|Biostate|1 dose of 50 IU FVIII/kg body weight of Biostate administered intravenously on Day 1 in the PK component, followed by the Efficacy component for continuation of Biostate therapy, as required for a minimum of 50 exposure days.
16221286|NCT01228994|Drug|Baclofen 30 mg/day|Baclofen 30 mg/day for 8 weeks with 2 week induction and 2 week decrease
16221287|NCT01228994|Drug|placebo pill|placebo pill
16221288|NCT01228994|Drug|Baclofen 60 mg/day|baclofen 60 mg/day for 8 weeks with 2 week induction and 2 week decrease
16221289|NCT01228942|Device|COXEN analysis for chemotherapy prediction|Using the affymetrix genechip along with the COXEN algorithm the subject's treatment will be determined
16221290|NCT01228929|Other|Environmental Chamber Condition Change Intervention|For condition change studies, the chamber will operate between 65 and 85 degrees F and 25% and 80% RH with air flow turned off or set to a maximum of 3-4 m/s. For this type of study, we will have the subject acclimate to a set of environmental conditions (approximately 20-30 minutes) and take a set of measurements. Then we will change the conditions (rate of change is 3 degrees F/hour and 3% RH/hour), have the subject acclimate to these conditions (later on the same day or on another day) and take another set of measurements. The expected study length is approximately two hours for a single visit. Subjects may be asked to return for additional visits to accommodate a variety of chamber conditions (temp, humidity, airflow) within the prescribed limits above.
16221291|NCT01228916|Behavioral|Tobacco Cessation and Secondhand Smoke Reduction|Awareness raising and resources for cessation and secondhand smoke reduction
16221292|NCT01228903|Drug|Allopurinol|Xanthine oxidase inhibitor- effective at lowering uric acid levels.
16221293|NCT01228903|Other|Placebo|Placebo tablets with no active ingredient
16221294|NCT01228890|Behavioral|CATCH-IT|"The CATCH-IT 2-R intervention has a motivational (3 PCP motivational interviews at time 0, 1.5 months and 12 months and 3 coaching phone calls at 2 and 4 weeks and 18 months) and an Internet component (with separate adolescent [14 modules] and parent [5 modules] programs). This revised and expanded intervention will include a comprehensive approach to reducing modifiable risk factors and enhancing resiliency factors associated with increased or decreased risk of depression, respectively, proposed by Spence and Reinecke.148 The revised CATCH-IT Tracker will monitor time in study and deploy elements of the intervention based on time since enrollment, including computer and human elements (e.g. calls, doctor visits)."
16221295|NCT01228890|Behavioral|AMPE|The AMPE components are similar to those employed in previous primary care based quality improvement/Chronic Care Model Interventions (patient education [psycho-education described below], provider training [described in Case Finding and Recruitment], active monitoring and referral [case management, discussed under assessments], physician and nurse education and routine contact with PCP [study design rationale]). This Internet site will focus on assisting parents and adolescents in early identification of need for treatment and will also target stigma and negative attitudes toward treatment of mental disorders we have previously identified as barriers to seeking and adhering to treatment.
16221296|NCT01228877|Other|exercise|Adduction, Abduction and Squat exercise three times a week for 16 weeks
16221297|NCT01228864|Procedure|quality of life|survey
16221298|NCT01228864|Procedure|Quality of life|
16221299|NCT01228851|Other|Balance Training|Group balance training sessions three times a week for 8 weeks
16221300|NCT01228838|Drug|NGX-1998|Capsaicin topical liquid to be applied for 5 minutes one time only.
16221301|NCT01228838|Drug|Placebo Liquid|Placebo topical liquid to be applied for 5 minutes one time only.
16221302|NCT01228799|Procedure|trabeculectomy|trabeculectomy with mitomycin C 0.2mg/ml
16221303|NCT01228799|Procedure|Canaloplasty|Canaloplasty with implant of suture
16221304|NCT01228773|Behavioral|Tailored web-based care program (Health Navigation®)|When intervention group participate in the Web-based care program (Health Navigation®), they can receive various information which is related with the CRF. Web-based fatigue care program consists of 6 strategic areas (energy conservation, nutrition, exercise, sleep disturbance, pain, and distress); three areas (pain, exercise, sleep disturbance) are based on the transtheoretical model (TTM), and others (energy conservation, distress, nutrition) are based on psycho-education method or cognitive behavioral therapy. Cancer survivors who participate in the Web-based care program (Health Navigation®) will be received tailored EMS/SMS message that notify participants of the next program's news and the last program's issue.
16221305|NCT01228760|Drug|ASG-5ME|IV
16221306|NCT01228747|Drug|Levetiracetam|Oral dose at flexible increase doses: 1000 mg/day or 2000 mg/day or 3000 mg/day, twice daily, 28 weeks
16221307|NCT01228747|Drug|Placebo|Matching oral placebo tablets twice daily for 28 weeks
16221308|NCT01228734|Drug|Cetuximab|Cetuximab was administered every 7 days at an initial dose of 400 milligram per square meter (mg/m^2) at 5 milligram per minute (mg/min) and 250 mg/m^2 at 10 mg/min for subsequent infusions until progression of disease, withdrawal of consent, or unacceptable toxicity to cetuximab.
16221309|NCT01228734|Drug|Oxaliplatin|Oxaliplatin 85 mg/m^2 infusion over 120 minutes on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity.
16221310|NCT01228734|Drug|Folinic Acid|FA 200 mg/m^2 infusion over 120 minutes on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity.
16221311|NCT01228734|Drug|5Fluorouracil|5-FU as a bolus of 400 mg/m^2/day intravenously over 2-4 minutes followed by 600 mg/m^2/day infusion over 22 hours on Day 1, Day 2, and then every 2 weeks until progression of disease, withdrawal of consent, or unacceptable toxicity.
16221312|NCT01228721|Device|Spectralis® SD-OCT, Heidelberg Engineering GmbH, H|
16221313|NCT01228708|Other|Active implementation of a guideline for chronic disease|"Smoking cessation courses Remuneration to GPs for the planned follow-up and joint home visits Action card and sputum colour advice Webpage on How to live with COPD and the support the health system can provide Database with patients with COPD Feed-back from health centre to GPs, when patients have finished courses Fax from hospital to GPs, when patients with COPD is discharged Routines to recall patients for follow-ups Team audit, evaluate and adjust the strategies every 3rd month Joint home visit with GP and community nurse when a patient with COPD is discharged to plan future care Practice staff do part of follow-ups and monitoring Practice supervision with consultant in lung diseases Podcast with advice from specialists Guideline for COPD"
16221314|NCT01228695|Other|sleep study|The polysomnography (PSG) (Alice 3 System; Healthdyne, Atlanta, GA) consisted of continuous polygraphic recording from surface leads for electroencephalography, electrooculography, electromyography, electrocardiography, thermistors for nasal and oral airflow, thoracic and abdominal impedance belts for respiratory effort, pulse oximeter for oxyhemoglobin level, tracheal microphone for snoring, and sensors for leg and sleep position
16221315|NCT01228682|Drug|Tolvaptan|Samsca 15mg tablet; Samsca 30mg tablet Administration as per Samsca SmPC and medical judgement of treating physician.
16221316|NCT01228669|Drug|NNC 0172-0000-2021|Single dose injected i.v. (into a vein). Each treatment dose is assessed for safety before escalating to next dose
16221317|NCT01228669|Drug|NNC 0172-0000-2021|Single dose injected s.c. (under the skin). Each treatment dose is assessed for safety before escalating to next dose.
16221318|NCT01228669|Drug|placebo|Single dose injected i.v. and s.c. Each treatment dose is assessed for safety before escalating to next dose.
16221319|NCT01228656|Drug|mometasone furoate + salicylic acid|Dermatologic ointment applied once a day.
16221320|NCT01228656|Drug|Mometasone furoate|Dermatologic ointment applied once a day
16221321|NCT01228643|Biological|Pancreatic enzimes|- Norzyme ® (product testing) composition: 20.000USP lipase, 65.000USP of 65.000USP amylase and protease.
16221322|NCT01228643|Device|Creon ®|- Creon ® (reference product) composition: 25.000UI lipase, amylase 74.700UI 62.500UI and protease
16221323|NCT01228630|Drug|Cloratadd-D|The patients receive one pill of treatment every 12 hours ( to get up and going to bed), of a glass of water.
16221324|NCT01228630|Drug|Allegra-D|The patients receive one pill of treatment every 12 hours ( to get up and going to bed), of a glass of water.
16221325|NCT01228617|Drug|Nicotine|Following a 12-hour nicotine abstinence period, subjects receive a single 2 mg dose of their assigned nicotine replacement therapy in the morning of the treatment visit day
16221326|NCT01228617|Drug|Nicotine Gum|Following a 12-hour nicotine abstinence period, subjects will be instructed to chew the gum once every 2 seconds, for 30 minutes.
16221327|NCT01228604|Drug|methylphenidate (Ritalin®)|The scheme provides for initial dose of 0.3 mg / kg / day, with an average dose of 1mg/kg/day. The increases will be made considering the presentation of the drug (10mg), which allows increments of 5mg or 10mg, which will be made in clinical review, as the clinical symptoms, including increasing the dose until there is more room for improvement or there is presence of significant adverse effects, all the patients with indication of treatment will be assessed before the use of medication, 15 days, 30 days, 3 and 6 months after the start,
16221328|NCT01228591|Device|Acuvue Advance Plus|Silicone hydrogel contact lens.
16221329|NCT01228591|Device|Acuvue Advance|Silicone hydrogel contact lens
16221330|NCT01228578|Dietary Supplement|Multivitamin supplements B,C and E|One daily recommended dietary allowance of multivitamins B,C and E or placebo taken daily for 18 months
16221331|NCT01228565|Other|Radiotherapy + Erbitux® + placebo|3D radiotherapy 70 Gy / 7 weeks (no IRMT); Erbitux once a week, 1 week before radiotherapy and during radiotherapy ; Placebo local application, once a day, every day during the radiotherapy
16221332|NCT01228565|Other|Radiotherapy+Erbitux+OTD70DERM|3D radiotherapy 70 Gy / 7 weeks (no IRMT); Erbitux once a week, 1 week before radiotherapy and during radiotherapy ; OTD70DERM local application, once a day, every day during the radiotherapy
16221333|NCT01228552|Drug|Topical, intra-oral ketoprofen gel|Ketoprofen gel will be applied, using a cotton applicator, to the gingival mucosa at the onset of migraine. A second application may be used at 20 minutes, if necessary.
16221334|NCT01228552|Other|Placebo gel|Placebo gel will be applied, using a cotton applicator, to the gingival mucosa at the onset of migraine. A second application may be used at 20 minutes, if necessary.
16221335|NCT01228539|Behavioral|TARGET (Trauma Affect Regulation)|TARGET teaches a skill sequence for affect regulation and social/interpersonal information processing.
16221336|NCT01228539|Behavioral|Prolonged Exposure|Cognitive behavior therapy with trauma memory exposure
16221337|NCT01228526|Device|PriMatrix|
16221338|NCT01228513|Drug|ZK245186|Daily topical application
16221339|NCT01228513|Drug|Placebo (vehicle without active ingredient)|Daily topical application
16221340|NCT01228500|Device|PriMatrix|Dermal Repair Scaffold
16221341|NCT01228474|Other|Select the Number of embryos to transfer|Select the Number of embryos to transfer
16221342|NCT01228448|Procedure|PET scan|In-Room PET scan
16221343|NCT01228435|Drug|IPI-504|Given intravenously twice weekly for 2 weeks followed by 10 day off treatment
16221344|NCT01228422|Biological|Interferon alpha 2a|3MUI
16221345|NCT01228409|Drug|Acitretin 17.5 mg/day|lower dose of Acitretin to 17.5 mg/day from 25 mg/day in those experiencing retinoid-related side effects
16221346|NCT01228396|Drug|Hyperimmune caprine serum against HIV lysate|1.0ml solution for subcutaneous injection (4.5mg total protein / ml) twice weekly for 4 weeks
16221347|NCT01228383|Biological|Rabies virus-specific monoclonal antibodies|CL184 20 IU/kg intramuscularly on Day 0.
16221348|NCT01228383|Biological|human polyclonal rabies immune globulin (HRIG)|HRIG 20 IU/kg intramuscularly on Day 0.
16221349|NCT01228383|Biological|Placebo|Placebo intramuscularly on Day 0.
16221350|NCT01228383|Biological|Human diploid cell vaccine (HDCV)|Rabies vaccine (HDCV) given on Days 0, 3, 7, 14, and 28.
16221443|NCT01227759|Drug|Placebo|Placebo containing no active ingredient
16221351|NCT01228383|Biological|Purified verocell rabies vaccine (PVRV)|Rabies vaccine (PVRV) given on Days 0, 3, 7, 14, and 28.
16221352|NCT01228370|Drug|silodosin|silodosin 8mg once a day for 12 weeks
16221353|NCT01228357|Drug|SSRI treated group|Antidepressant administration of SSRI class for 12 weeks under therapeutic dose
16221354|NCT01228357|Drug|non-SSRI treated group|Antidepressant administration of non-SSRI class for 12 weeks under therapeutic dose
16221355|NCT01228344|Other|Artemether-lumefantrine|
16221356|NCT01228331|Drug|Amsacrine|one block amsacrine together with etoposide and methylprednisolone for very high risk patients
16221357|NCT01228331|Drug|Clofarabine|one block clofarabine with Asparaginase for MRD positive patients after induction
16221358|NCT01228331|Drug|Cyclophosphamide|together wit MTX and ASP in consolidation and together with cytarabine and 6-TG in reinduction
16221359|NCT01228331|Drug|Cytarabine|part of different chemotherapy blocks in consolidation and reinduction
16221360|NCT01228331|Drug|Daunorubicin hydrochloride|part of induction and reinduction therapy
16221361|NCT01228331|Drug|Dexamethasone|part of reinduction therapy
16221362|NCT01228331|Drug|Doxorubicin hydrochloride|part of reinduction therapy
16221363|NCT01228331|Drug|Etoposide phosphate|part of different chemotherapy blocks
16221364|NCT01228331|Drug|Mercaptopurine|part of different chemotherapy blocks
16221365|NCT01228331|Drug|Methotrexate|part of different chemotherapy blocks
16221366|NCT01228331|Drug|Methylprednisolone|part of different chemotherapy blocks
16221367|NCT01228331|Drug|Pegaspargase|part of different chemotherapy blocks
16221368|NCT01228331|Drug|Thioguanine|part of different chemotherapy blocks
16221369|NCT01228331|Drug|Vincristine sulfate|part of intravenous chemotherapy
16221370|NCT01228331|Radiation|Whole-brain radiation therapy|patients with initial cns involvement receive cranial irradiation
16221371|NCT01228318|Drug|Zoledronic acid|"A single dose of reclast containing 5 mg/100 mL ready-to-infuse zoledronic acid solution administered over 15-30 minutes.
~A single dose of placebo containing 220 mg mannitol and 24 mg sodium citrate in a 100 mL ready-to-infuse solution, administered over 15-30 minutes."
16221372|NCT01228305|Other|Acetaminophen|Acetaminophen will be given at a standard dose of 15 mg/kg IV every 6 hours for children >=2 years of age, 12.5mg/kg IV every 6 hours for children 29 days to <2 years of age, and 7.5mg/kg IV every 6 hours for neonates up to 28 days old for a total of 4 doses, starting shortly after intubation in the OR and before the start of CPB.
16221373|NCT01228292|Drug|Unfractionated heparin|dose 5-10 IU/kg/hrs adaptations of infusion rate upon APTT measurements during hemodialysis
16221374|NCT01228292|Drug|Citrasate|Citrasate is infused as a dialysate
16221375|NCT01228279|Other|DIANEAL|"Weeks 1 to 6 (6 weeks):
~CAPD (Continuous Ambulatory Peritoneal Dialysis)patients will receive three 4-6 hour dwells of DIANEAL during the day and one 8-10-hour dwell of DIANEAL during the night
~CCPD (Continuous Cycler Peritoneal Dialysis)patients will receive one-two 4-6 hour dwells of DIANEAL during the day and three to seven 2-4-hour dwells of DIANEAL during the night
~Weeks 7 to 18 (12 weeks):
~*same regimen as weeks 1 to 6, for both CAPD and CCPD patients"
16221376|NCT01228279|Other|EXTRANEAL|"Weeks 1 to 6 (6 weeks):
~CAPD (Continuous Ambulatory Peritoneal Dialysis)patients will receive three 4-6 hour dwells of DIANEAL during the day and one 8-10-hour dwell of DIANEAL during the night
~CCPD (Continuous Cycler Peritoneal Dialysis)patients will receive one-two 8-12-hour dwells of DIANEAL during the day and three to seven 2-4-hour dwells of DIANEAL during the night
~Weeks 7 to 18 (12 weeks):
~CAPD (Continuous Ambulatory Peritoneal Dialysis)patients will receive three 4-6 hour dwells of DIANEAL during the day and one 8-10-hour dwell of EXTRANEAL during the night
~CCPD (Continuous Cycler Peritoneal Dialysis)patients will receive one-two 8-12-hour dwells of DIANEAL during the day and one 8-12-hour dwell of EXTRANEAL during the night"
16221377|NCT01228266|Biological|autologous mesenchymal stem cells|A randomized double-blind, crossover study comparing treatment with autologous MSC vs. suspension media on patients with active MS
16221378|NCT01228253|Device|rTMS: repetitive transcranial magnetic stimulation|patients will be treated with rTMS at 10 Hz (D3 to D7 and D10-D14, 1 session / day)
16221379|NCT01228253|Device|SHAM rTMS: repetitive transcranial magnetic stimulation is off|patients will be treated with rTMS at 10 Hz (D3 to D7 and D10-D14, 1 session / day with the stimulator on off
16221380|NCT01228240|Drug|Metformin|
16221381|NCT01228227|Drug|ATORVASTATIN 80 mg|reload of Atorvastatin 80 mg before the procedure
16221382|NCT01228227|Drug|ROSUVASTATIN 40 mg|reload of rosuvastatin 40 mg before the procedure
16221383|NCT01228214|Drug|Placebo|Placebo 5mg/daily for 12 months
16221384|NCT01228214|Drug|amiloride|5mg/daily for 12 months
16221385|NCT01228201|Behavioral|Moderate continuous training|Three training sessions per week in a total of 12 weeks
16221386|NCT01228201|Behavioral|Aerobic interval training|Three training sessions per week in a total of 12 weeks
16221387|NCT01228188|Procedure|Inverted ILM Repositioning|Three port pars plana vitrectomy is performed by one surgeon (JR). Induction of PVD is initiated by active suction with the vitrectomy probe over the ONH and continued peripherally. First a 0.6-1.0mm piece of ILM surrounding the macular hole is removed. Then significant margin of ILM in macular hole circumference is released while staying connected at the base to the macularrhexis border. Excess of ILM is trimmed. Perfluorocarbon is administrated, stabilizing ILM flap and facilitating the flap repositioning. Trypan Blue is used to stain the ILM. ILM flap is pressed down over the macular hole. The procedure is ended by SF6 gas tamponade. Even in absence of cataract formation, a combined procedure is performed because of exact peripheral vitreous shaving and prevention of cataract formation.
16221388|NCT01228175|Drug|Placebo|25mg look alike riboflavin tablets to match active study medication.
16221389|NCT01228175|Drug|Varenicline|Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily
16221390|NCT01228162|Procedure|effect of muscle relaxation on muscle trauma, control group without relaxation|effect of muscle relaxation on muscle trauma, control group without relaxation
16221391|NCT01228149|Drug|Trabeculectomy with preoperative Diamox/DexaEDO treatment|Filtrating glaucoma surgery, preoperative treatment with Diamox (acetazolamide) 28 day prior surgery. DexaEDO (dexamethasone) 7 days prior surgery
16221392|NCT01228149|Drug|Trabeculectomy with preoperative Cosopt S treatment|Filtrating glaucoma surgery, preoperative treatment with Cosopt S (dorzolamide/timolol) 28 day prior surgery.
16221393|NCT01228136|Drug|Tranexamic Acid|10mg/Kg, IV (in the vein), first dose 30 minutes before surgery, second dose 8 hours after first dose, third dose 8 hours after second dose
16221394|NCT01228136|Other|normal saline solution|normal saline solution in the same volume calculated as treatment (tranexamic acid 250mg/mL, 10mg/Kg), IV (in the vein) first dose 30 minutes before surgery, second dose 8 hours after first dose, third dose 8 hours after second dose
16221395|NCT01228123|Other|RRT for acute kidney failure using the CVVH method|patients randomized to receive CVVH
16221396|NCT01228123|Other|RRT for acute kidney failure using the IHD (intermittent HD)|patients randomized to receive IHD
16221397|NCT01228110|Drug|Hydrocortison|
16221398|NCT01228110|Drug|Saline Solution|
16221399|NCT01228084|Drug|Sulforaphane|Sulforaphane given 200μmol (total daily) orally in four 50μmol capsules taken once daily from Week 1 Day 1 to Week 20 Day 7. On days when clinic visits are required patient must wait to take that day's dose until instructed to do so in clinic.
16221400|NCT01228084|Other|Laboratory biomarker analysis|Correlative studies
16221401|NCT01228084|Other|Pharmacological study|Correlative studies
16221402|NCT01228071|Drug|testosterone gel 2%|40 mg testosterone gel 2%
16221403|NCT01228058|Procedure|RapidTEG test|The RapidTEG test will be done at the study time points (3, 6, 12, 24 hours and 4 addiitonal days).
16221404|NCT01228045|Drug|Trastuzumab in Combination with TS-ONE and cisplatin|Subjects will receive treatment that combined TS-ONE, cisplatin and trastuzumab every 3 weeks in this study. This 3 weeks period of time is called a cycle. The cycle will be repeated until subject experience disease progression or unbearable toxicities or they choose to withdraw from the study. Each cycle is numbered in order.
16221405|NCT01228032|Other|Care team|The ICC will provide care for both the index cardiometabolic conditions and common acute and chronic comorbidities.
16221406|NCT01228019|Drug|Niacin (+) laropiprant|Niacin (+) laropiprant (TREDAPTIVE) prescribed according to the current local label
16221407|NCT01228006|Dietary Supplement|NatusGerin|1 capsule, 2 times a day.
16221408|NCT01228006|Other|Placebo capsules|1 capsule, 2 times a day
16221409|NCT01227993|Drug|Finasteride|
16221410|NCT01227980|Drug|Pexacerfont|300 mg, orally, once/day during week 1, 100 mg, orally, once/day during weeks 2 and 3.
16221411|NCT01227980|Drug|Placebo|300 mg, orally, once/day during week 1, 100 mg, orally, once/day during weeks 2 and 3.
16221412|NCT01227967|Drug|Amantadine, Ribavirin, Oseltamivir|Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg, three capsules of Ribavirin 200 mg for total of 600 mg, and one capsule of Amantadine 100 mg.
16221413|NCT01227967|Drug|Oseltamivir|Subjects were prescribed the medication twice daily for 5 days, and each dose consisted of one capsule of Oseltamivir 75 mg.
16221414|NCT01227954|Radiation|intensity-modulated radiation therapy|30 Gy in 10 fractions to the whole brain using intensity-modulated radiation therapy excluding the hippocampal avoidance area. Bilateral hippocampal contours manually generated on the fused planning MRI CT image set by the treating physician according to protocol-specified contouring instructions. Hippocampal avoidance regions generated by three-dimensionally expanding the hippocampal contours by 5 mm.
16221415|NCT01227941|Drug|MK-4827 + pegylated liposomal doxorubicin|Initial evaluation of a 16-day dosing schedule: A loading dose of MK-4827 will be administered orally on Days 1-2 of the cycle and a maintenance dose daily on Days 3-16. Pegylated liposomal doxorubicin 40 mg/m^2 will be administered intravenously on Day 3 of each cycle. The maintenance dose of MK-4827 will be escalated, until the maximum tolerated dose (MTD) is determined. If the maintenance dose is escalated above the loading dose, the loading dose will be escalated to a level equal to the maintenance dose, for the subsequent cycle. Other dosing schedules of MK-4827 may be explored, including 7-, 10-, 21- and 28-day schedules.
16221416|NCT01227941|Drug|MK-4827 + pegylated liposomal doxorubicin|MK-4827 will be administered according to one or two dose schedules as determined in Part A. Pegylated liposomal doxorubicin 40 mg/m^2 will be administered intravenously on Day 3 of the cycle.
16221417|NCT01227928|Drug|Pazopanib|Pazopanib 800 mg daily for 24 months
16221418|NCT01227928|Drug|Placebo comparator|Placebo 800 mg daily for 24 months
16221419|NCT01227915|Drug|Tobracort|tobramycin 0.3% + dexamethasone 1%
16221420|NCT01227915|Drug|Tobradex|tobramycin 0.3% + dexamethasone 1%
16221421|NCT01227902|Drug|Retigabine IR|Flexible dose between 300 mg/day (minimum) and 1200 mg/day (maximum).
16221422|NCT01227889|Drug|GSK2118436|150 mg twice daily
16221423|NCT01227889|Drug|Dacarbazine (DTIC)|Intravenous (IV), 1000 mg/m2 every 3 weeks until initial progression
16221424|NCT01227876|Drug|Ster|prednisolone 1% ophthalmic suspension
16221425|NCT01227876|Drug|Pred Fort|prednisolone 1% ophthalmic suspension
16221426|NCT01227863|Drug|MAXINOM®|Dexamethasone...............................................0,1% Neomicyn......................................0,35% polimixyn B...................................0,1%
16221427|NCT01227863|Drug|Maxitrol®|Dexamethasone...............................................0,1% Neomicyn......................................0,35% Polimixyn B...................................0,1%
16221428|NCT01227837|Dietary Supplement|placebo|placebo given to patients
16221429|NCT01227837|Dietary Supplement|omga3|use of omega 3
16221430|NCT01227824|Drug|GSK1349572 (dolutegravir)|GSK1349572 50 mg taken once daily with or without food
16221431|NCT01227824|Drug|raltegravir|raltegravir 400mg taken twice daily
16221432|NCT01227824|Other|GSK1349572 Placebo|GSK1349572 placebo taken once daily
16221433|NCT01227824|Other|ABC/3TC|Abacavir/Lamivudine background therapy once daily
16221434|NCT01227824|Other|TDF/FTC|Tenofovir/emtricitabine background therapy once daily
16221435|NCT01227824|Other|raltegravir Placebo|raltegravir placebo taken twice daily
16221436|NCT01227811|Drug|Darifenacin|Single oral dose Darisec(R) 15.0 mg
16221437|NCT01227811|Drug|Darifenacin|Single oral dose Enablex(R) 15 mg
16221438|NCT01227798|Drug|Interferon alfacon-1|15 mcg at fill volume of 0.5mL
16221439|NCT01227798|Drug|Placebo|Normal Saline
16221440|NCT01227785|Device|INCEPTA ICD or CRT-D|
16221441|NCT01227772|Biological|OTSGC-A24|OTSGC-A24 administered at 1 mg in weekly, 2-weekly, and 3-weekly cohorts.
16221442|NCT01227759|Drug|Drug containing the active ingredient|The topical application is performed once daily during a 12-day treatment.
16221444|NCT01227746|Procedure|Tumor biopsies|
16221445|NCT01227733|Other|Breast Tumor Blocks|
16221446|NCT01227720|Drug|Experimental Nicotine Replacement Therapy (NRT) 2 mg|2 mg Single-dose of new NRT product (NSL2L)
16221447|NCT01227720|Drug|Experimental Nicotine Replacement Therapy (NRT)|4 mg Single-dose of new NRT product
16221448|NCT01227720|Drug|Marketed Nicotine Lozenge|2 mg Single-dose of marketed lozenge
16221449|NCT01227720|Drug|Marketed Nicotine Lozenge|4 mg Single-dose of marketed lozenge
16221450|NCT01227707|Drug|bevacizumab [Avastin]|5 mg/kg intravenously every 2 weeks, 4 cycles
16221451|NCT01227707|Drug|capecitabine [Xeloda]|825 mg/m2 twice daily orally, 38 days
16221452|NCT01227707|Radiation|Radiation therapy|Total dose of 45 Gy over 38 days
16221453|NCT01227707|Procedure|Mesorectal excision|6-8 weeks after completion of neoadjuvant treatment
16221454|NCT01227707|Drug|bevacizumab [Avastin]|Post-surgery adjuvant treatment at the discretion of the investigator: 5 mg/kg iv every 2 weeks for at least 6 months
16221455|NCT01227707|Drug|5-fluorouracil|Post-surgery adjuvant therapy: bolus of 400mg/m2 iv plus iv infusion of 600 mg/m2 on Days 1 and 2 of each 2-week cycle for 6 months
16221456|NCT01227707|Drug|leucovorin|Post-surgery adjuvant treatment: 100 mg/m2 iv on Days 1 and 2 of each 2-week cycle for 6 months
16221457|NCT01227694|Other|Autologous MSC knee implantation|"Isolation and Ex-Vivo expansion of Mesenchymal stem cells (MSC) obtained from each patient's bone marrow under GMP conditions at Xcelia-División de Terapias avanzadas del Banc de Sang I Teixits. After 21 days, approximately 40 millions of autologous MSC will be implanted in the knee by articular injection."
16221458|NCT01227681|Drug|G-CSF|G-CSF(granulocyte-colony stimulating factor) is planned injected subcutaneously
16221459|NCT01227681|Drug|Placebo|Sodium Chloride (NaCl) 0.9 %
16221460|NCT01227668|Drug|Aripiprazole|Tablets, Oral, 2-15 mg, once daily, 13-42 weeks
16221461|NCT01227668|Drug|Placebo|Tablets, Oral, 0 mg, once daily, 16 weeks
16221462|NCT01227655|Drug|BIA 9-1067|Capsules will be used.
16221463|NCT01227655|Drug|Placebo|comparator
16221464|NCT01227655|Drug|Levodopa|
16221465|NCT01227655|Drug|Carbidopa|DOPA decarboxylase inhibitor (DDCI)
16221466|NCT01227655|Drug|Benserazide|DOPA decarboxylase inhibitor
16221467|NCT01227642|Other|An ultrasound-based technique to identify prostate cancer|The technique uses current ultrasound equipment already in use for prostate brachytherapy guidance.By extracting and processing the radiofrequency signal obtained from the ultrasound transducer in ways not done to create the standard B-mode ultrasound image, areas of cancer can be identified and displayed overlying the standard B-mode ultrasound image. Comparing the results with this technique to the results of prostate biopsies demonstrates a high degree of accuracy with the area under the receiver-operator characteristic curve of 0.87, a result superior to any other imaging methods.
16221468|NCT01227642|Other|pre-implant transrectal ultrasound images and planning|an ultrasound-based technique to identify cancer-containing areas within the prostate.
16221469|NCT01227642|Other|ultrasound-based cancer-specific images|ultrasound-based cancer-specific images of the prostate prior to the brachytherapy and use them to direct the dosimetry planning
16221470|NCT01227629|Drug|dabigatran with ASA|dose comparison in combination
16221471|NCT01227629|Drug|dabigatran with ASA|dose comparison in combination
16221472|NCT01227629|Drug|dabigatran with ASA|dose comparison in combination
16221473|NCT01227629|Drug|dabigatran with ASA|dose comparison in combination
16221474|NCT01227629|Drug|dabigatran with ASA|dose comparison in combination
16221475|NCT01227629|Drug|dabigatran with ASA|dose comparison in combination
16221476|NCT01227629|Drug|warfarin|comparator
16221477|NCT01227629|Drug|dabigatran without ASA|dose comparison
16221478|NCT01227629|Drug|dabigatran without ASA|dose comparison
16221479|NCT01227629|Drug|dabigatran without ASA|dose comparison
16221480|NCT01227616|Drug|Ferumoxytol|IV Ferumoxytol
16221481|NCT01227616|Drug|Iron Sucrose|IV Iron Sucrose
16221482|NCT01227603|Drug|Nifedipine-candesartan FDC (BAY 98-7106)|Single dose of 1 FDC tablet consisting of 60 mg nifedipine GITS and 32 mg candesartan
16221483|NCT01227603|Drug|Nifedipine GITS (Adalat LA, BAYA1040)|Single oral dose of 1 tablet of nifedipine GITS 60 mg
16221484|NCT01227603|Drug|Candesartan (Atacand)|Single oral dose of 32 mg (2 x 16 mg tablet) candesartan
16221485|NCT01227590|Drug|Kaletra (lopinavir/ritonavir), African Potato (hypoxis obtusa)|The baseline PK of LPV/r will be established after 14 days of taking LPV/r at a dose of 400/100 mg twice daily. This will be followed by a 7 day course of LPV/r and AP together. The AP dose to be administered will be 15 mg/kg/day of hypoxoside.
16221486|NCT01227577|Drug|Nilotinib|Nilotinib was supplied as 150 mg and 200 mg hard gelatin capsules.
16221487|NCT01227564|Biological|ACC-001 3 μg/ QS-21 50 μg|ACC-001 3 μg/ QS-21 50 μg IM on day 1, month 1, month 3, month 6, month 12, and month 18
16221488|NCT01227564|Biological|ACC-001 10 μg/ QS-21 50 μg|ACC-001 10 μg/ QS-21 50 μg IM on day 1, month 1, month 3, month 6, month 12, and month 18
16221489|NCT01227564|Other|Placebo- Phosphate buffered saline (PBS)|Phosphate buffered saline IM on day 1, month 1, month 3, month 6, month 12, and month 18
16221490|NCT01227551|Biological|Coxsackievirus A21 (CVA21)|CVA21 is a live oncolytic virus preparation derived from the non-genetically altered prototype Kuykendall strain of Coxsackievirus A21.
16221491|NCT01227538|Other|Mixed meal stimulated urinary C peptide for the assessment of residual beta cell function|Study will be designed to assess stimulated urinary C-peptide in comparison to mixed-meal stimulated plasma C-peptide response in the same individual in 30 number of patients with Type 1 diabetes.
16221492|NCT01227525|Device|Vibraject|The VibraJect clips onto the barrel of a conventional and intraligamentary dental syringe (and some disposable syringes) and vibrates the needle at a high frequency while injections are administered.
16221493|NCT01227512|Drug|tolvaptan|15 mg titrated to 30 mg then 60 mg once daily as oral tablet for up to 7 days based on response.
16221494|NCT01227512|Other|Fluid Restriction|"Placebo tablet once daily with prescribed daily fluid intake of 1500 mL, then intensifying to 2 lower volumes of fluid intake for up to 7 days based on response.
~Since all particpants were blinded to treatment, titration to stricter fluid restriction followed the same algorithm as tolvaptan, increasing both the level of fluid restriction and increasing the placebo dose"
16221495|NCT01227486|Device|Ultrasound|Ultrasound scan just proximal to the suprasternal notch during intubation and ultrasound scan of both lungs during ventilation
16221496|NCT01227473|Behavioral|Mindfulness-based diabetes prevention education group|The mindfulness-based diabetes prevention group meets for 2 ½ hours per week for eight weeks, with one 4-hour retreat between the 6th and 7th weeks, and monthly booster sessions for 6 months. During the 8-week interventions, this group receives a 30-minute health behavior presentation (based on the landmark Diabetes Prevention Program). In the mindfulness-based diabetes prevention group, the instruction will be enhanced with a modified mindfulness meditation training designed to support the behavioral-change programming.
16221497|NCT01227473|Behavioral|Conventional diabetes prevention education group|The conventional diabetes prevention education group meets for 2 ½ hours per week for eight weeks, with one 4-hour retreat between the 6th and 7th weeks, and monthly booster sessions for 6 months. During the 8-week interventions, the group receives a 30-minute health behavior presentation (based on the landmark Diabetes Prevention Program). In the conventional diabetes prevention group, the instruction will be enhanced with group exercises and discussions.
16221498|NCT01227460|Drug|Sitagliptin|pill/tablet form of 100mg each. will take one tablet a day throughout study
16221499|NCT01227460|Drug|Sugar Pill|100mg tablet once a day
16221500|NCT01227434|Drug|PD 0332991 (pre-surgery)|PD 0332991 for 7 days prior to an indicated, intended surgical resection for progression
16221501|NCT01227434|Drug|PD 0332991|PD 0332991 daily for 21 consecutive days followed by a 7 day break off therapy, repeating cycles
16221502|NCT01227434|Procedure|Resection as clinical care|Indicated, intended, surgical resection as clinical care
16221503|NCT01227421|Drug|Nitazoxanide|Tablets, 300 mg (one 300 mg tablet + 1 placebo tablet) with food twice daily for 5 days
16221504|NCT01227421|Drug|Nitazoxanide|Tablets, 600 mg (two 300 mg tablets) with food twice daily for 5 days
16221505|NCT01227421|Drug|Placebo|Tablets, (2 tablets) twice daily with food for 5 days
16221506|NCT01227408|Drug|doxorubicin, paclitaxel poliglumex, capecitabine, cyclophosphamide, methotrexate|doxorubicin 20mg/m2 weekly x 12 wks, cyclophosphamide 50 mg PO qd x 12 wks, methotrexate 2.5 mg PO bid d1,2 wkly x 12. One week later paclitaxel poliglumex 135mg/m2 IV every 3 wks plus capecitabine 825 mg/m2 PO bid x 14days x 4 cycles
16221507|NCT01227395|Drug|Azithromycin|"Inhibition of onset: Perorally administer 1200mg of azithromycin (potency) once a week to adults.
~Treatment: Perorally administer 600mg of azithromycin (potency) once a day to adults."
16221508|NCT01227382|Procedure|ERCP with cholangiopancreatoscopy|Endoscopic Retrograde Cholangiopancreatography (ERCP)with cholangiopancreatoscopy and sampling of stricture with SpyBite biopsy forceps, cytology brush and RJ3biopsy forceps
16221509|NCT01227369|Other|OPSAT-Q|A linguistically validated Korean version of OPSAT-Q
16221510|NCT01227356|Drug|imatinib and pegylated interferon|imatinib 400 mg p.o. daily pegylated interferon 50 ug s.c. weekly
16221511|NCT01227330|Behavioral|Medication adherence intervention|12-week behavioral feedback intervention to improve adherence to statin medication
16221512|NCT01227330|Behavioral|Attention-control|Health education visits that are unrelated to medications or cholesterol, provided on the same visit schedule as the intervention group
16221513|NCT01227317|Other|Prognostic value of Biomarkers|Mr pro ADM, Mr pro ANP, PCT, Copeptin and pro endothelin value to stratify the risk in SOB patients
16221514|NCT01227304|Device|PiCCO-parameter-guided volume challenge|Infusion of 7ml/kg crystalloid over 30 minutes, Performing transpulmonary thermodilutions after 0min, 15min and 30min. Recording of pulse contour cardiac index, heart rate and mean arterial pressure after 5, 10, 15, 20, 25 and 30min. Catecholamines are kept stable over the 30min period.
16221515|NCT01227291|Drug|SYL040012|SYL040012 ophthalmic drops, daily single dose administration
16221516|NCT01227278|Other|Placebo|Placebo matched to benralizumab (MEDI-563) injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
16221517|NCT01227278|Biological|Benralizumab 100 mg|Benralizumab (MEDI-563) 100 mg injection subcutaneously every 4 weeks for the first 3 doses and then every 8 weeks for the next 5 doses (Day 1, 29, 57, 113, 169, 225, 281 and 337).
16221518|NCT01227265|Drug|Preladenant|Preladenant 2 mg or 5 mg oral tablet taken twice daily
16221519|NCT01227265|Drug|Placebo|Preladenant-matching placebo oral tablet taken twice daily
16221520|NCT01227252|Drug|LY2886721|5 milligrams (mg) up to 35 mg, administered orally as capsules, daily for 14 days
16221521|NCT01227252|Drug|Placebo|Administered orally as capsules, daily for 14 days
16221522|NCT01227239|Drug|S-1|40mg/m2 orally twice a day (BID) for 5 days a week at 1st week, 2nd week, 4th week and 5th week.
16221523|NCT01227239|Drug|Oxaliplatin|40-60mg/m2/week intravenously on day 1, 8, 22 and 29.
16221524|NCT01227239|Radiation|Radiation|Total dose is 50.4Gy (1.8Gy X 28 fractions)
16221525|NCT01227226|Drug|Artificial tears|Instill one drop of artificial tears
16221526|NCT01227200|Drug|dypiron, tramadol|dypiron 4 ML, tramadol 50 mg flashtab
16221527|NCT01227187|Drug|Drotrecogin alfa activated|We plan to determine the optimal dose of Xigris needed to achieve PTT between 65 and 100 secs. The study will test different dose regimens of Xigris. The initial patients will receive Xigris dosed at an infusion rate of 12 mcg/kg/h via the pre-filter arterial drip chamber via a standard intravenous pump. The PTT will be assessed from blood samples drawn at baseline,15,30,60,120 and 180 mins. The dose of Xigris will be adjusted in the following patients if the afferent PTT rises above 100 secs (normal range 25-40 secs) or if PTT remains <65 secs. If PTT remains less than 65 secs, the dose will be increased to the second dose regiment of 18 mcg/kg/hr. The dose escalation will continue in increments of 6 mcg/kg/h to a maximum dose of 36 mcg/kg/h. Each patient will receive Xigris only once.
16221528|NCT01227174|Drug|Propofol|Procedural sedation will be achieved using propofol
16221529|NCT01227148|Other|Tightly glucose control|A continuous insulin infusion (50 IU of Actrapid HM) in 49.5 ml of 0.9 percent sodium chloride with the use of a pump was started when blood glucose level exceeded 140 mg/dl to maintain a blood glucose level of between 120 and 140 mg per deciliter. The dose of insulin was adjusted according to whole-blood glucose levels, measured at one-four-hour interval in arterial blood or arterial catheter was not available. The insulin dose was adjusted by a neuro-fuzzy method
16221566|NCT01226758|Biological|Placebo (adjuvant only)|Single subcutaneous injection of adjuvant
16221614|NCT01226511|Drug|Duloxetine|Administered orally
16221530|NCT01227148|Other|Conventional glucose control|a continuous insulin infusion was delivered when the blood glucose level exceeded 200 mg/dl and insulin level was then adjusted to maintain a blood glucose level of between 180 and 200 mg per deciliter.
16221531|NCT01227135|Drug|hydroxychloroquine|
16221532|NCT01227135|Drug|imatinib mesylate|
16221533|NCT01227135|Genetic|cytogenetic analysis|
16221534|NCT01227135|Genetic|polymerase chain reaction|
16221535|NCT01227135|Other|laboratory biomarker analysis|
16221536|NCT01227135|Other|pharmacological study|
16221537|NCT01227096|Device|Electrical acupuncture stimulation|electroacupuncture would be administered on the bilateral P6 acupoint after anesthesia induction, but prior to surgery.
16221538|NCT01227057|Behavioral|Cognitive Rehabilitation and Exposure Therapy for Compulsive Hoarding|The intervention includes cognitive remediation for deficits in executive functioning and exposure therapy for discarding/acquiring.
16221539|NCT01227057|Behavioral|Case Management|Case management
16221540|NCT01227044|Drug|Naltrexone|NTX arm will receive monthly extended release NTX doses at 380mg (4 mL), administered as an intramuscular gluteal injection at 4-week intervals.
16221541|NCT01227044|Other|Placebo + Medication Management/Medication Coaching|Placebo + Medication Management/Medication Coaching
16221542|NCT01227018|Drug|STA-9090|Given IV
16221543|NCT01227018|Radiation|Radiologic imaging|radiologic modalities used to evaluate response to treatment
16221544|NCT01227018|Procedure|blood draw|Venous blood will be drawn from those patients who give consent. Serum will be used to look for biomarkers predictive of response
16221545|NCT01227005|Biological|Transfusion of blood products|The intervention will be either a) administration of 1 unit of whole blood plus pooled products or b) administration of component therapy (red blood cells, plasma, platelets).
16221546|NCT01226992|Drug|Vancomycin|"Oral Vancomycin:
~Dose: 125 mg po qid x 2 weeks then 125 mg po bid x 1 week then 125 mg po od x 1 week then 125 mg po q every other day x 1 week then 125 mg po q every third day x 1 week then discontinue Route: oral"
16221547|NCT01226992|Biological|Fecal Transplant|Fecal slurry 50 grams stool in 500ml normal saline
16221548|NCT01226979|Radiation|High-dose endorectal brachytherapy (HDRBT)|The investigational tool being evaluated is high-dose endorectal brachytherapy (HDRBT) which is an FDA approved method to administer endoluminal radiation for low rectal cancer.
16221549|NCT01226966|Drug|liraglutide|Prescription is done at the discretion of the prescribing physician as part of normal clinical routine.
16221550|NCT01226953|Biological|Haemophilus influenzae type b (Hib) vaccine|Comparator study of two commercially available Haemophilus influenzae type b (Hib) vaccines
16221551|NCT01226927|Other|Automated intermittent bolus|Automated intermittent bolus delivery method of 0.2% ropivacaine at 5 mL every 30 minutes with a basal infusion of 0.1 mL/hr.
16221552|NCT01226914|Drug|EVICEL|EVICEL
16221553|NCT01226901|Drug|MK-4827|MK-4287, 150 mg or 300 mg capsule, orally, once daily in 21 day cycles.
16221554|NCT01226875|Procedure|SWL: Shock Wave Lithotripsy Intervention|Shock wave lithotripsy (SWL) is the most common treatment modality for kidney stones. It is a safe and non-invasive treatment performed on patients under intravenous sedation (light anesthesia) on an out-patient basis, whereby shock waves are generated by a source external to the patient's body and are then propagated into the body and focused on a kidney stone. The unique quality of SWL is in its exploitation of shock wave focusing. The Storz lithotripter is an electromagnetic lithotripter with a unique design that allows for a dual focus system with the option of either a narrow (6x28 mm) or wide (9x50 mm) focal zone, depending on the clinical situation. This is the first lithotripter on the market to allow for two different focal zones for shock wave targeting.
16221555|NCT01226849|Drug|bortezomib, rituximab, ifosphamide, etoposide, carboplatin|Rituximab 375mg/m2 day 1 Etoposide 100mg/m2 day 1-3 Carboplatin AUC (5) max 800 days 2 Ifosfamide continuous infusion + Mesna 5/m2/24hr day2 Bortezomib 1.3mg/m2 days 1,4,8,11 G-CSF (SC) recommended
16221556|NCT01226836|Other|LWWCOPD for Pulmonary Rehabilitation|As part of clinical care participants will attend a 6 week pulmonary rehabilitation programme consisting of supervised exercise and education sessions. The exercise component will be consistent with the usual pulmonary rehabilitation programme delivered at that site (BTS 2001, NICE 2004). The education sessions will be delivered using the revised LWWCOPD programme (1/week, approx. 30-45min). All health professionals will be provided with the health professionals' manual and supplementary posters for their respective education session. All participants will be provided with the revised LWWCOPD information booklet and an action plan for recognising and managing exacerbations.
16221557|NCT01226823|Drug|Ursodeoxycholic Acid|300 mg capsules 20 mg/kg body weight/day divided in three administrations per day from enrolment until delivery
16221558|NCT01226823|Drug|Placebo|300 mg capsules 20 mg/kg body weight/day divided in three administrations per day from enrolment until delivery
16221559|NCT01226797|Drug|Placebo|Take 4 capsules twice daily 12 hours apart with water. Swallow whole.
16221560|NCT01226797|Drug|PF-04136309|Take 4 capsules twice daily 12 hours apart with water. Swallow whole.
16221561|NCT01226784|Behavioral|Physcial activity|Strenght training Relaxation exercise
16221562|NCT01226771|Drug|"Ribavirin loading dose given"|PEG-IFN α-2a 180 μg/week plus loading (≥26 mg/kg/day for 2 weeks followed by ≥13 mg/kg/day) and concentration targeted (≥ 2.5 mg/L, i.e ≥ 10.25 μmol/L, as measured after 4 weeks of therapy) dosing of ribavirin and response guided treatment duration (RVR 24 weeks, non-RVR 48 weeks, pEVR consider 72 weeks), follow-up period 24 weeks
16221563|NCT01226771|Drug|"Priming dose of ribavirin given"|Standard-of-care dosing of ribavirin (≥13 mg/kg/day) without PEG-IFN for 4 weeks followed by 24-48 additional weeks of PEG-IFN α-2a 180 μg/week plus standard-of-care dosing of ribavirin (≥13 mg/kg/day) and concentration targeted (≥ 2.5 mg/L, i.e ≥ 10.25 μmol/L, as measured after 28 days after the initiation of ribavirin) dosing of ribavirin and response guided treatment duration (RVR 28 weeks, non-RVR 52 weeks, pEVR consider 76 weeks), follow-up period 24 weeks
16221564|NCT01226771|Drug|"Group C (Standard-of-Care)"|PEG-IFN α-2a 180 μg/week plus standard-of-care dosing of ribavirin (≥13 mg/kg/day without any measurement of ribavirin concentration) and response guided treatment duration (RVR 24 weeks, non-RVR 48 weeks, pEVR consider 72 weeks), follow-up period 24 weeks
16221565|NCT01226758|Biological|Influenza vaccine (FLU-v)|FLU-v (sterile lyophilised mixture of polypeptide T-cell epitope sequences) and adjuvant. Administered by single subcutaneous injection.
16221567|NCT01226745|Drug|ONO-4641|Subjects will be administered with ONO-4641 at a dose of 0.15 milligram (mg) in the core study will be administered with ONO-4641 0.15 mg in this extension study for a duration of 225 weeks.
16221568|NCT01226745|Drug|ONO-4641|Subjects will be administered with ONO-4641 at a dose of 0.10 mg in the core study will be administered with ONO-4641 0.10 mg in this extension study for a duration of 225 weeks.
16221569|NCT01226745|Drug|ONO-4641|Subjects will be administered with ONO-4641 at a dose of 0.05 mg in the core study will be administered with ONO-4641 0.05 mg in this extension study for a duration of 225 weeks.
16221570|NCT01226745|Drug|ONO-4641|Subjects will receive placebo in the core study will be administered with ONO-4641 0.15 mg in this extension study for a duration of 225 weeks.
16221571|NCT01226745|Drug|ONO-4641|Subjects will receive placebo in the core study will be administered with ONO-4641 0.10 mg in this extension study for a duration of 225 weeks.
16221572|NCT01226745|Drug|ONO-4641|Subjects will receive placebo in the core study will be administered with ONO-4641 0.05 mg in this extension study for a duration of 225 weeks.
16221573|NCT01226732|Drug|Capecitabine|Taken orally twice daily on Days 1 through 14 of 21 day cycle.
16221574|NCT01226732|Drug|Hsp90 Inhibitor AUY 922|IV infusion over 60 minutes on Days 1, 8, and 15 of each 21 day cycle
16221575|NCT01226719|Drug|Panitumumab|6 mg/kg, 60-90 minute IV infusion every 2 weeks
16221576|NCT01226719|Drug|Oxaliplatin|85 mg/m2, 2-hour IV infusion every 2 weeks
16221577|NCT01226719|Drug|Irinotecan|125 mg/m2, 1-hour IV infusion every 2 weeks
16221578|NCT01226719|Drug|Leucovorin|200 mg/m2, 2-hour IV infusion every 2 weeks
16221579|NCT01226719|Drug|5-Fluorouracil|3200 mg/m2 IV, 48-hour continuous infusion every two weeks
16221580|NCT01226706|Drug|Botulinum Toxins, Type A|Botulinum Toxins, Type A 100U injected into the detrusor at Day 1
16221581|NCT01226706|Drug|Placebos|Placebos injected into the detrusor at Day 1, followed by injection of botulinum toxin Type A 100U after 24 weeks has elapsed from previous treatment, if requested/qualified.
16221582|NCT01226693|Drug|PH-797804 material sparing tablet|oral, 6mg, single dose
16221583|NCT01226693|Drug|PH-797804 Phase2b/3 with sodium lauryl sulphate|oral, 6mg, single dose
16221584|NCT01226693|Drug|PH-797804 Phase2b/3 with sodium lauryl sulphate|oral, 6mg, single dose
16221585|NCT01226693|Drug|PH-797804 material sparing tablet|oral, 6mg, single dose
16221586|NCT01226693|Drug|PH-797804 material sparing tablet|oral, 6mg, single dose
16221587|NCT01226693|Drug|PH-797804 Phase2b/3 without sodium lauryl sulphate|oral, 6mg, single dose
16221588|NCT01226693|Drug|PH-797804 Phase2b/3 without sodium lauryl sulphate|oral, 6mg, single dose
16221589|NCT01226693|Drug|PH-797804 material sparing tablet|oral, 6mg, single dose
16221590|NCT01226693|Drug|PH-797804 Phase2b/3 without sodium lauryl sulphate|oral, 6mg, single dose
16221591|NCT01226693|Drug|PH-797804 Phase2b/3 with sodium lauryl sulphate|oral, 6mg, single dose
16221592|NCT01226693|Drug|PH-797804 Phase2b/3 with sodium lauryl sulphate|oral, 6mg, single dose
16221593|NCT01226693|Drug|PH-797804 Phase2b/3 without sodium lauryl sulphate|oral, 6mg, single dose
16221594|NCT01226680|Drug|Tasocitinib|0.005% QD for 12 weeks
16221595|NCT01226680|Drug|Tasocitinib|0.003% QD for 12 weeks
16221596|NCT01226680|Drug|vehicle for Tasocitinib|vehicle QD for 12 weeks
16221597|NCT01226667|Drug|Pregabalin|"Fixed dosing of pregabalin: Week 1: 75 mg bid. Weeks 2 - 8: 150 mg bid. Week 9 (Days 57-60 and Days 61-63): 75 mg bid.
~Flexible dosing of pregabalin: Week 1: placebo in the AM and 75 mg nightly; Week 2: placebo in the AM and 150 mg nightly.; Week 3 placebo in the a.m., 225 mg nightly; Weeks 4 - 8 placebo in the a.m., 300 mg nightly. Week 9 (Days 57-60) placebo in the a.m,, 150 mg bid nightly and Days 61-63: placebo in the a.m., and 75 mg bid nightly."
16221598|NCT01226654|Device|Magnetic Resonance Imaging|Magnetic Resonance Imaging EDSS
16221599|NCT01226641|Device|Telemedicine|CPAP treatment with telemedicine system
16221600|NCT01226641|Device|Standard care|Standard care, including CPAP
16221601|NCT01226628|Biological|CNTO 2476|
16221602|NCT01226628|Procedure|iTrack Model 275 micro catheter|CNTO 2476 will be administered subretinally using the iTRACK microcatheter in participants with visual acuity impairment. During surgery, the portion of microcatheter distal to the flexible blue hub is inserted into the subretinal space via a peripheral scleral cutdown and choroidal fistula.
16221603|NCT01226615|Drug|Chondroitin sulphate (Condrosan®)|800mg (two capsules of 400mg each) taken once a day for four months
16221604|NCT01226615|Drug|Placebo|Two placebo capsules taken once a day for four months.
16221605|NCT01226602|Drug|AZD6140|P2Y12 receptor antagonist
16221606|NCT01226602|Drug|Placebo|
16221607|NCT01226589|Procedure|MRS|
16221608|NCT01226576|Device|MRgFUS Treatment|Local treatment of prostate cancer using Magnetic Resonance Imaging guided endorectally applied focused ultrasound energy
16221609|NCT01226563|Device|IK-5001|4 mL (+/- 0.2 mL) administered through intracoronary slow bolus injection over 15 to 30 seconds at least 2 days after PCI but within 5 days of onset of symptoms.
16221610|NCT01226563|Device|Saline Solution|4 mL (+/- 0.2 mL) slow bolus, intracoronary injection of saline solution will be administered over 15 to 30 seconds at least 2 days after percutaneous coronary intervention (PCI) but within 5 days of onset of symptoms.
16221611|NCT01226550|Procedure|cytoreductive surgery and HIPEC|"The most complete cytoreductive surgery possible (ideally macroscopically complete) followed by a closed-abdomen hyperthermic intraoperative peritoneal chemotherapy (HIPEC), using a closed circuit connected to the self-regulating Cavitherm machine (EEC certified). This perfusion apparatus records temperature, flow, and pressure for 90 minutes at real temperature (42-43°C).
~The dialysate is made up of peritoneal dialysis fluid containing 0.7 mg/kg of MMC and increasing doses of irinotecan added to the dialysate the last 30 minutes of the HIPEC.
~Potentiation of irinotecan using an intravenous FUFOL perfusion at least 1hour before HIPEC (1st dose level: 10 mg/m² of folinic acid, then 200 mg/m² of 5-FU; 2nd dose level: 20 mg/m² of folinic acid, then 400 mg/m² of 5-FU)."
16221612|NCT01226537|Drug|Taurine|500 mg taurine capsules twice per day for 6 months
16221613|NCT01226524|Drug|Bu Zhong Yi Qi Tang, Zhi Xue Tang, Chuan xin lian kang yan pian mod, Tian Wang Bu xin Dan|A traditional Chinese Medicine (TCM) therapist will diagnose and prescribe the herbal remedies according to TCM principles from one of four formulations or any combination of the four formulation
16221615|NCT01226511|Drug|Placebo|Administered orally
16221616|NCT01226498|Procedure|Red blood Cells auto-transfusion|Withdrawal from 10 Healthy volunteers of one unit of red blood cells and auto-transfusion after 3 days for one arm of the study, after 40 days for the other. Participants are enrolled in both arms of the study.
16221617|NCT01226485|Drug|Taladegib|Administered IV
16221618|NCT01226472|Biological|KW-0761|In the first treatment course KW-0761 will be administered i.v. once a week for four weeks, followed by a 2-week observation period. Subsequent treatment courses are permissible for subjects demonstrating a response or maintaining stable disease and will consist of an infusion of KW-0761 every other week.
16221619|NCT01226459|Drug|5% Minoxidil Topical Foam|Dosage Form: 5% Minoxidil Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks
16221620|NCT01226459|Drug|Vehicle Topical Foam|Dosage Form: Vehicle Topical Foam applied to the scalp; Dosage: half a cap, equivalent to 1 g of foam; Frequency: once every day; Duration: 24 weeks
16221621|NCT01226446|Drug|vitamin D|Vitamin D on top of the standard treatment
16221622|NCT01226420|Drug|Alefacept|Given intravenously Days 1 and 4 of Week 1, then subcutaneously once weekly for Weeks 2-12
16221623|NCT01226407|Drug|CG200745|Multiple administration (IV) over the cycles untile MTD/LTD
16221624|NCT01226394|Procedure|laparotomy plus HIPEC|Laparotomy + HIPEC
16221625|NCT01226381|Drug|Von Frey electronic|This protocol is based on a study of the interaction setron / paracetamol at 4 different levels of plasma concentrations, by repeating the tests at set intervals, while concentrations of setrons down gradually (half-life of 8 to 10 am ) after a single administration. In addition, the interindividual variability of the effects of paracetamol will be studied, and linking with certain genetic polymorphisms reported by the subjects tested
16221626|NCT01226368|Other|Biological Sample collection|Cervix cells
16221627|NCT01226355|Device|stent|"NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System is manufactured by Medfavour (Beijing) Medical Co., Ltd.
~Firebird drug-eluting stents from MicroPort Medical (Shanghai) Co., Ltd."
16221628|NCT01226342|Device|Transcutaneous electrical muscle stimulation|On the first hospitalization day patients received lower extremity TCEMS. We used GymnaUniphy device (GymnaUniphy N.V., 2004, 3740 Bilzen, Belgium) with four surface patch electrodes applied over each lower extremity quadriceps muscle. Patients were in the supine position and were advised to relax during sessions. A prespecified program for lower extremity strength training in sessions of 25 minutes, twice a day (first training in the morning, second in the afternoon, with minimal time difference of 6 hours) was performed six days per week during the hospitalization.
16221629|NCT01226329|Behavioral|Right Question Project - Mental Health (RQP-MH)|"The RQP-MH trainings each take approximately 45 minutes to complete and are delivered approximately three weeks apart. The manualized intervention uses a Question Formulation Technique (QFT) and a Framework for Active Decision-Making (FADM). The QFT consists of asking patients to generate and revise questions to obtain more informative answers from their providers. The FADM teaches participants to identify questions that will help them consider their role in a decision, the process of decision-making, and the reasons behind a decision. All intervention sessions will be taught by a bachelors-level Care Manager."
16221630|NCT01226329|Behavioral|Pamphlet|"Participants in this group receive a handout called Managing Your Mental Health (available in Spanish and English) that provides tips on how to manage mental health through the proper maintenance of physical health and stress."
16221635|NCT01226303|Drug|ATRA|see the protocol
16221636|NCT01226303|Drug|ATRA + IDA|see the protocol
16221637|NCT01226290|Device|VizAblate System|VizAblate enables a minimally invasive procedure to visualize, target, and ablate uterine fibroids using intrauterine ultrasound and radiofrequency (RF) energy.
16221638|NCT01226277|Drug|GDC-0917|Oral repeating dose
16221639|NCT01226264|Procedure|Diffusion weighted MRI (DW- MRI)|"An MRI examination (including diffusion-weighted sequences) belongs to the standard protocol for patients with cervical uterine cancer. The additional burden is therefore restricted to an extra MRI scan during and/or early after therapy.
~MRI is a technique based on magnetic fields and do not require the use of ionizing radiation. Because of the strong magnetic field, a few precautions should be taken. This means that all metal and magnetized objects must be removed from the patient before entering the MRI room. Patients with a pacemaker, a cardiac defibrillator or other implanted conductor/prosthesis are for this reason not eligible for the study.
~During the examination, an intravenous and vaginal contrast medium will be administered. In most cases, patients do not experience any discomfort and the use of these contrast agents is part of the clinical routine."
16221640|NCT01226251|Device|In vitro chair side test|Colour evaluation of a strip
16221641|NCT01226238|Other|Online self-help|Provision of online self-help
16221642|NCT01226225|Behavioral|Aerobic interval training|Patients will enter a training program during which aerobic interval training is implemented. Three sessions per week, each lasting for 60 minutes. Total duration of the program: 3 months.
16221643|NCT01226225|Behavioral|Moderate endurance training|Patients will enter a training program during which moderate endurance training is implemented. Three sessions per week, each lasting for 60 minutes. Total duration of the program: 3 months.
16221644|NCT01226212|Dietary Supplement|Synbiotic (Synergy 1/B. longum)|Combination of a prebiotic Synergy 1 and a probiotic Bifidobacterium longum
16221645|NCT01226212|Dietary Supplement|Placebo|maltodextrose
16222042|NCT01222975|Drug|Risperidone|orally disintegrating tablets
16221646|NCT01226186|Behavioral|Nurse dispensed oral morphine.|Nurse will dispense oral morphine on request from the patient.
16221647|NCT01226186|Behavioral|Patient self medication of oral morphine.|Patients will self medicate their oral morphine pain control solution following surgery.
16221648|NCT01226173|Device|Bio-Rad Platelia Dengue NS1 Ag test|The purpose of the study is to screen blood donors for the presence of dengue NS1 antigen at the ARC in Puerto Rico region using the Bio-Rad Platelia Dengue NS1 Ag test.
16221649|NCT01226160|Procedure|Postoperative face-down posturing|Postoperative face-down posturing for 10 days after surgery.
16221650|NCT01226160|Procedure|Postoperative non-posturing group|avoid a face-up position only for 10 days after surgery
16221651|NCT01226147|Drug|Tamibarotene|4mg/day for 24 weeks.
16221652|NCT01226134|Drug|Itopride,|Itopride,50 mg capsules,thrice a day,for Four weeks
16221653|NCT01226134|Drug|Placebo|placebo capsules,thrice a day for four weeks
16221654|NCT01226121|Biological|Clostridial collagenase injectable|Finger manipulation performed 1, 2, or 4 days following collagenase injection
16221655|NCT01226108|Device|Patch|"One patch per day, Duration: three weeks, Administration: behind the ear
~--------------------------------------------------------------------------------"
16221656|NCT01226082|Device|Transcranial Direct Current Stimulation|Patients will recieve tDCS in a 5-day period of treatment
16221657|NCT01226069|Drug|Glycerine Magnesium sulphate paste|Dosage to apply adheres to the manufacturer's recommendation. Sufficient amount should cover the erythema size. Dose frequency is 12 hourly.
16221658|NCT01226069|Drug|Mucopolysaccharide polysulphate|Dosage to apply adheres to the manufacturer's recommendation. Sufficient amount should cover the erythema size. Dose frequency is 12 hourly.
16221659|NCT01226069|Other|No application|No application
16221660|NCT01226056|Drug|RAD001 in combination with sorafenib|"Phase I / Dose escalation: during the first cycle RAD001 (2.5-10 mg/day) will be administered alone, once a day, on days 1-14 to allow PK-profiling of the drug. From day 15 sorafenib administration (400-800 mg/day) twice a day will be added.
~The cycle 1 will last 6 weeks, subsequent cycles will last 4 weeks (the 2 drugs administered in combination from day 1 to day 28).
~Phase II: The drugs will be administered at the Recommended Dose and each treatment cycle will last 4 weeks."
16221661|NCT01226043|Drug|Insulin Glargine|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous"
16221662|NCT01226030|Drug|M2ES 7.5mg|M2ES 7.5mg
16221663|NCT01226030|Drug|M2ES 15mg|M2ES 15mg
16221664|NCT01226030|Drug|M2ES 30mg|M2ES 30mg
16221665|NCT01226030|Drug|M2ES 60mg|M2ES 60mg
16221666|NCT01226017|Other|Measuring oxytocin level in blood|Blood sampling and instruments measuring anxiety and stress
16221667|NCT01225991|Drug|Milnacipran|All subjects will be free of antidepressant medications or opiates, or any other medications used to treat pain for at least 2 weeks prior to initiation of dose titration. Patients will be allowed to escalate up to 100 mg a day: Day 1: 12.5 mg once a day; Days 2-3: 25 mg/day (12.5 mg twice daily); Days 4-7: 50 mg/day (25 mg twice daily); After Day 7: 100 mg/day (50 mg twice daily). The stable-dose phase will be a 10-week period during which patients will take medications at the final dose achieved (either 100 mg per day in divided doses, or the maximum tolerated dose of less than 100 mg per day).
16221668|NCT01225978|Device|GeneInsight Clinic (GIC)|"GeneInsight Clinic (GIC) is a clinical interface tool that provides genetics IT support infrastructure designed to address key genetic data and knowledge management issues.
~The GIC enables the delivery of patient specific alerts when new information is learned about a variant after it has been reported to a treating clinician. The prototype for this study shows multiple tests, Hypertrophic Cardiomyopathy test updates, hearing loss test updates and broad spectrum genotyping test updates. Our intention is to build this functionality in a scalable manner that will ultimately accommodate whole genome sequencing."
16221669|NCT01225965|Device|Ectoin Inhalation Solution|Once daily inhalation of Ectoin Inhalation Solution
16221670|NCT01225965|Device|Placebo|Once daily inhalation of Placebo Inhalation Solution
16221671|NCT01225952|Device|Crystalens AO|Bausch & Lomb model silicone multi-piece accommodating IOL.
16221672|NCT01225952|Device|ReSTOR 3.0|An aspheric multifocal IOL (Alcon Laboratories) combines the functions of an apodized diffractive region and a refractive region.
16221673|NCT01225952|Device|AMO Tecnis Multifocal|The Tecnis Multifocal foldable hydrophobic acrylic IOL, Model ZMA00 (Abbott Medical Optics), is an ultraviolet light-absorbing posterior chamber IOL.
16221674|NCT01225939|Drug|AZD8329|tablet
16221675|NCT01225939|Drug|AZD8329|Solution
16221676|NCT01225926|Device|Toric T3 - T9|Commercially available, acrylic, multifocal IOL intended to provide visual correction over the lifetime of the cataract patient
16221677|NCT01225926|Device|IQ SN60WF|Commercially available, acrylic, monofocal IOL intended to provide visual correction over the lifetime of the cataract patient
16221678|NCT01225913|Drug|fluticasone/salmeterol in all asthmatics|budesonide 80ug/formoterol 4.5ug, 2 inhalations bid X 20-60 days or fluticasone 100ug/salmeterol 50ug, 1 inhalation bid X 20-60 days
16221679|NCT01225913|Drug|budesonide/formoterol or fluticasone/salmeterol in all asthmatics|budesonide 160ug/formoterol 4.5ug, 2 inhalations bid or fluticasone 250ug/salmeterol 50ug, 1 inhalations bid
16221680|NCT01225887|Drug|Nintedanib|Given PO
16221681|NCT01225874|Drug|SC-PEG E. coli L-asparaginase|Given IM
16221682|NCT01225874|Drug|cytarabine|Given IT
16221683|NCT01225874|Drug|daunorubicin hydrochloride|Given IV
16221684|NCT01225874|Drug|dexamethasone|Given orally
16221685|NCT01225874|Drug|methotrexate|Given IT
16221686|NCT01225874|Drug|pegaspargase|Given IM
16221687|NCT01225874|Drug|prednisone|Given orally
16221688|NCT01225874|Drug|vincristine sulfate|Given IV
16221689|NCT01225835|Drug|Menotrophin|Starting on Day 2 or 3 of the menstrual cycle, 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met.
16221690|NCT01225835|Drug|Follitrophin alpha|Starting on Day 2 or 3 of the menstrual cycle, 150 IU (up to 300 IU) by subcutaneous injection once per day in the morning for up to 12 days until human chorionic gonadotropin (hCG) criteria are met.
16221848|NCT01224743|Dietary Supplement|Placebo|Placebo capsules are provided by the study sponsor and are identical in appearance to active treatments to ensure blinding.
16221691|NCT01225835|Drug|Cetrorelix|Participants self-inject subcutaneously Cetrorelix in the morning at a daily dose of 0.25 mg/day from Day 5 of gonadotrophin administration on and continue throughout the period of gonadotrophin treatment up to day 12 as a maximum. The last dose of Cetrorelix is given on the day of ovulation induction.
16221692|NCT01225835|Drug|Choriongonadotropin|10,000 IU administered by the Investigator or designated personnel in the evening of the day on which the hCG criterion is met (no later than Day 13). The criterion for hCG administration is three follicles >+17 mm diameter as shown by pelvic ultrasound examination.
16221693|NCT01225835|Drug|Progesterone|Vaginal gel progesterone is used once daily at a dose of 90 mg for a period of 30 days starting on the day of oocyte retrieval (approximately Day 14).
16221694|NCT01225822|Drug|Enoxaparin|Enoxaparin 40 mg s.c once a day for 5-10 days of treatment period
16221695|NCT01225822|Drug|BIBR 1048|50 mg b.i.d BIBR 1048 capsule twice a day for 5-10 days of treatment period
16221696|NCT01225822|Drug|BIBR 1048|150 mg b.i.d BIBR 1048 capsule twice a day for 5-10 treatment period
16221697|NCT01225822|Drug|BIBR 1048|225 mg b.i.d BIBR 1048 capsule twice a day for 5-10 treatment period
16221698|NCT01225822|Drug|BIBR 1048|300 mg q.d BIBR 1048 capsule for 5-10 treatment period
16221699|NCT01225796|Drug|Sodium bicarbonate|Sodium bicarbonate 650mg by mouth three times daily for 6 months.
16221700|NCT01225783|Other|Self measurement of limb volume +water displacement|Comparison will be made between self measurement is two types of tape measure compared with water displacement
16221701|NCT01225770|Dietary Supplement|green tea|Gargling three times daily for 90 days
16221702|NCT01225757|Device|Echocardiogram|Echocardiography will be utilized during the procedure to guide fluid management.
16221703|NCT01225744|Drug|Cetuximab|"Cetuximab will be prepared under Good Manufacturing practice (GMP) and supplied by Merck KGaA (Darmstadt, Germany) as a solution for intravenous infusion. It will be made up into 250ml with N/Saline.
~Dose administered is 400mg/m2 and will be given on day 1 and day 15 of a 28 day cycle.Cetuximab will always be administered first, i.e. the cetuximab infusion should be completed one hour before any chemotherapy begins. The cetuximab dose must always be based on the body surface area(BSA). There is no restriction for cetuximab in patients with a BSA > 2 m2 ."
16221704|NCT01225744|Drug|Irinotecan|Dose is 180mg/m2 made up into 250ml with 5% dextrose or 0.9% saline. It will be administered as a short infusion over 60-90 minutes after a 60 minute gap left after cetuximab administration. Irinotecan is administered on day 1 of the 28 day cycle.
16221705|NCT01225744|Drug|Oxaliplatin|Dose is 100mg/m2 and will be made up into 250ml with 5% dextrose. It will be administered as a short infusion over 120 minutes after the 60 minute gap left after cetuximab administration. Oxaliplatin is administered on day 15 of the 28 day cycle.
16221706|NCT01225744|Drug|UFT|UFT dose is 250mg/m2 and is given in three divided doses with calcium folate 30mg p.o. tds on days 1-21 of the 28 day cycle. The highest dose of UFT should be given in the morning if the dose cannot be divided equally.
16221707|NCT01225731|Biological|tildrakizumab|SC administration of tildrakizumab at assigned dose
16221708|NCT01225731|Drug|Placebo|SC administration of Placebo
16221709|NCT01225705|Drug|raltegravir|Patients will be randomized 1:1 to either the experimental or the active control arm
16221710|NCT01225705|Drug|Atazanavir/ritonavir|Patients will be randomized 1:1 to either the experimental or the active control arm
16221711|NCT01225692|Behavioral|Head Injury Guideline|
16221712|NCT01225679|Device|positive airway pressure, Non-invasive mechanic ventilation|"Vpap: 16 cm H2O inspiratory and 8 cm H2O expiratory pressures, 20 irpm.
~Mechanic ventilation: tidal volume of 850 ml; 16 irpm; inspiratory pressure of 40 mmHg; PEEP: 5 cm H2O."
16221713|NCT01225666|Drug|MOD-4023|liquid solution for subcutaneous injection - 30% of the cumulative weekly dose achieved with daily rhGH, Once weekly
16221714|NCT01225666|Drug|MOD-4023|liquid solution for subcutaneous injection - 45% of the cumulative weekly dose achieved with daily rhGH, Once weekly
16221715|NCT01225666|Drug|MOD-4023|liquid solution for subcutaneous injection - 100% of the cumulative weekly dose achieved with daily rhGH, Once weekly
16221716|NCT01225666|Drug|MOD-4023|liquid solution for subcutaneous injection - 100% of the cumulative weekly dose achieved with daily rhGH, every-other week (50% of the two-weekly cumulative dose)
16221717|NCT01225653|Drug|Latanoprost|Topical application
16221718|NCT01225640|Drug|PNU-100480|600 mg twice daily (BID) for 14 days
16221719|NCT01225640|Drug|PNU-100480|1200 mg once daily (QD) for 14 days
16221720|NCT01225640|Drug|RHZE|Combination tablet (RHZE) dosed by weight. Dosage strength per tablet is 150 mg Rifampicin (R)/75 mg Isoniazid (H)/400 mg Pyrazinamide (Z)/275 mg Ethambutol (E)
16221721|NCT01225627|Other|Coordinated discharge|In intervention group, a discharge coordinator contacts hospitalized patients the day after randomization. During hospitalization, discharge coordinator visits are scheduled according to patients' problems and home-care needs. At 48 hours after hospital discharge, a discharge coordinator calls patients by phone to check the process of adjustment to home environment and to inquire about additional needs patients might have. Thereafter, phone contacts are scheduled according to the patients' needs and 7-10 days after the hospital discharge a home visit is performed by discharge coordinator, respectively.
16221722|NCT01225627|Other|Control|Patients in control group will be managed by attending physician, primary care physician, and/or pneumologist in accordance with established clinical practice.
16221723|NCT01225614|Device|Bilevel pressure ventilator|Nocturnal home ventilation
16221724|NCT01225601|Behavioral|Tabacco discontinuation|Tabacco discontinuation
16221725|NCT01225575|Drug|co.don chondrosphere®|"co.don chondrosphere® are spheroids in suspension, developed from autologous chondrocytes.
~The dose in group A is 3-7 spheroids/cm2 defect, in group B 10-30 spheroids/cm2 defect and in group C 40-70 spheroids/cm2 defect"
16221726|NCT01225562|Drug|Ticagrelor 90 mg|Oral dose twice a day
16221727|NCT01225562|Drug|Ticagrelor 60 mg|Oral dose twice a day
16221728|NCT01225562|Drug|Ticagrelor Placebo|Oral dose twice a day
16221729|NCT01225549|Drug|AZD5423|Suspension for nebulisation once daily 7 days
16221730|NCT01225549|Drug|Budesonide 200 microgram|Dry powder for inhalation twice daily 7 days
16221731|NCT01225549|Drug|Placebo|Solution for nebulisation once daily 7 days
16221732|NCT01225549|Drug|Placebo|Solution for nebulisation once daily 7 days
16221733|NCT01225536|Drug|ARQ 736|Subjects in this study will receive ARQ 736 orally at dose levels specified for their respective dose cohorts. Dosing will begin at 900 mg/day (first cohort) and escalate until the recommended Phase 2 dose or maximum tolerated dose is determined. Cycles will be repeated in four-week (28-day) intervals until progression of disease, unacceptable toxicity, or another discontinuation criterion is met. In the case of toxicity, dose adjustment will be permitted.
16221734|NCT01225523|Drug|Paclitaxel; Cisplatin; 5-Fluorouracil|Two preoperative cycles with Paclitaxel 200 mg/m² d1, Cisplatin 60 mg/m² d1, 5-Fluorouracil 700 mg/m² d1-5 repeated every 3 weeks followed by resection
16221735|NCT01225523|Drug|Paclitaxel; Cisplatin; 5-Fluorouracil; Capecitabine|Two postoperative cycles with Paclitaxel 200 mg/m²/day d1, Cisplatin 60 mg/m²/day d1, 5-Fluorouracil 700 mg/m²/day d1-5 repeated every 3 weeks Among patients with no responses to preoperative chemotherapy, Capecitabine 625 mg/m² twice-daily dose as alternatives to infused 5-Fluorouracil in the postoperative chemotherapy regimen
16221736|NCT01225510|Biological|PF-04856884|PF-04856884 at a dose of 15 mg/kg/week
16221737|NCT01225510|Biological|PF-04856884|PF-04856884 at a dose of 15 mg/kg/week
16221738|NCT01225497|Procedure|Standard eccentric exercise|"Participants stand with the balls of their feet on a step. They rise up onto tip toes using both legs then transfer onto the affected leg, then slowly lower their heel below the level of the step keeping their weight-bearing limb fully straight (eccentric phase). This constitutes 1 repetition and is repeated for 3 x 15 reps.
~The previous procedure is then carried out with the knee bent during the eccentric phase of loading for 3 x 15 reps.
~All of the above is carried out twice a day as per Alfredsons protocol. Participants are encouraged as per Alfredsons procedure to continue into discomfort not severe pain."
16221739|NCT01225497|Procedure|Eccentric exercise-Experimental group|Eccentric exercise is performed the same as in the standard group. However participants in this group are encouraged to do the number of repetition they can manage so long as it is also to discomfort.
16221740|NCT01225484|Procedure|Continuous femoral nerve block + periarticular infiltration|Initial bolus of ropivacaine 5mg/ml 30mls into the femoral-nerve-catheter preoperatively. Periarticular infiltration of ropivacaine 2mg/ml 150 mls intraoperatively. Continuous perineural infusion of ropivacaine 2mg/ml at a rate of 6 mls/hr postoperatively. Rate can be adjusted to achieve optimal pain control and avoid motor blockade.
16221741|NCT01225484|Procedure|Intraarticular and periarticular ropivacaine|Periarticular infiltration of 150 mls ropivacaine 2mg/ml intraoperatively, intraarticular injection of 40 mls ropivacaine 2 mg/ml at skin closure followed by infusion of ropivacaine 2 mg/ml at a rate of 4 mls/hr delivered by an intraarticular catheter until the morning of postoperative day 3.
16221742|NCT01225471|Biological|CDCA1|CDCA1-A24-56 will be administered by subcutaneously injection once every week for 3 months thereafter once two weeks. This peptide conjugated with Montanide ISA 51 as an adjuvant.
16221743|NCT01225458|Other|shorter tests|Geriatric evaluation with MMS, GDS and ADL scoring
16221744|NCT01225458|Other|initial complete geriatric tests|evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : only at the first visit
16221745|NCT01225458|Other|follow-up complete geriatric tests|evaluation of cognitive functions, psychological functions, dependency in activities, vision, audition, mobility and nutritional status : every 6 month for 3 years
16221746|NCT01225445|Drug|Ramipril|2.5 mg daily
16221747|NCT01225432|Other|Gait Training|12 sessions, 30 minutes of walking on a treadmill with real time therapist directed feedback on gait kinematics.
16221748|NCT01225419|Drug|Plerixafor, mozobil|Subcutaneous injection of 240 µg/kg of Plerixafor (Mozobil ®, Genzyme) at 8 am the day of the cytapheresis. Determination of CD34+ cells circulating in h0 then every hour of h3 to h11. Taking by cytapheresis from the 5th hour of the injection if the rate of CD34+ is upper or equal in 10.106/l. If the rate of CD34+ in the blood does not reach 10.106/l after the first injection of plerixafor or if the first cytapheresis does not allow the collection of at least 5.106/kg CD34+ cells, the patient will be considered in failure and a conventional mobilization by G-CSF will be programmed
16221749|NCT01225406|Drug|Tenofovir|
16221750|NCT01225393|Drug|MLTA3698A|Subcutaneous repeating dose
16221751|NCT01225393|Drug|adalimumab|Subcutaneous repeating dose
16221752|NCT01225393|Drug|leflunomide|Stable dose if not on methotrexate
16221753|NCT01225393|Drug|methotrexate|Stable dose if not on leflunomide
16221754|NCT01225393|Drug|placebo|Subcutaneous repeating dose
16221755|NCT01225380|Drug|GS-9190|GS-9190 capsule, 20 mg BID, 16 or 24 weeks
16221756|NCT01225380|Drug|GS-9256|GS-9256 capsule, 150 mg BID, 16 or 24 weeks
16221757|NCT01225380|Biological|Pegasys®|peginterferon alfa-2a, (solution for injection) 180 µg/week, up to 48 weeks
16221758|NCT01225380|Drug|Copegus®|ribavirin 200 mg tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day >/= 75 kg) divided twice daily (BID), up to 48 weeks
16221759|NCT01225380|Drug|GS-9190 placebo|placebo matching GS-9190 capsule BID, 24 weeks
16221760|NCT01225380|Drug|GS-9256|GS-9256 capsule, 150 mg BID, 24 weeks
16221761|NCT01225380|Biological|Pegasys®|peginterferon alfa-2a (solution for injection) 180 µg/week, up to 48 weeks
16221762|NCT01225380|Drug|Copegus®|ribavirin 200 mg tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day >/= 75 kg) divided twice daily (BID), up to 48 weeks
16221763|NCT01225380|Drug|GS-9190 placebo|placebo matching GS-9190 capsule BID, 24 weeks
16221764|NCT01225380|Drug|GS-9256 placebo|placebo matching GS-9256 capsule BID, 24 weeks
16221765|NCT01225380|Biological|Pegasys®|peginterferon alfa-2a (solution for injection) 180 µg/week, 48 weeks
16221766|NCT01225380|Drug|Copegus®|ribavirin 200 mg tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day >/= 75 kg) divided twice daily (BID), 48 weeks
16221767|NCT01225367|Device|ultrasound doppler monitoring|Regular noninvasive chest echo monitoring
16221768|NCT01225354|Drug|Calcium hydroxylapatite|Subjects will be treated to full correction at visit 1 and, if needed, a touch-up injection at 2 weeks.
16221769|NCT01225341|Drug|onabotulinumtoxinA|Botox® is supplied in a 100 U vial and will be reconstituted with 3.3 mL of 0.9% Sodium Chloride Injection USP to yield a solution of 3 U per 0.1 mL. Study treatment will consist of an injection of Botox® (onabotulinumtoxinA) (3 U/ 0.1 mL) into the orbicularis oris muscle (8 U, .27 mL in the upper and/or lower lip, depending on the site of recurrence) using a 30G needle.
16221849|NCT01224730|Drug|perifosine|100 mg daily
16221770|NCT01225341|Other|Bacteriostatic normal saline|Study treatment will consist of an injection of bacteriostatic normal saline, into the orbicularis oris muscle (8 U, .27 mL in the upper and/or lower lip, depending on the site of recurrence) using a 30G needle.
16221771|NCT01225328|Behavioral|Behavioral activation/problem-solving (BA/PS)|Six weekly telephone sessions to train participant in BA/PS procedures
16221772|NCT01225315|Drug|Placebo|Matching placebo administered orally twice daily
16221773|NCT01225315|Drug|Setipiprant|ACT-129968 (Dose 1, Dose 2, or Dose 3) administered orally twice daily
16221774|NCT01225302|Drug|Linifanib|Low dose linifanib (once a day)
16221775|NCT01225302|Drug|Linifanib|High dose linifanib (once a day)
16221776|NCT01225302|Drug|Carboplatin|Given on Day 1 of every 21-day cycle
16221777|NCT01225302|Drug|Paclitaxel|Given on Day 1 of every 21-day cycle
16221778|NCT01225289|Dietary Supplement|Vitamin A|25000 IU/day (one capsule per day) Vitamin A for 6 months
16221779|NCT01225289|Drug|Placebo|1 capsule per day for six months
16221780|NCT01225276|Drug|NewGam 10%|Loading dose at baseline (Week 0) will be 2.0 g/kg NewGam . The maintenance doses to be infused 7 times will be 2.0 g/kg every 21 (+/-4) days.
16221781|NCT01225276|Drug|Placebo|Loading dose at baseline (Week 0) in Placebo arm will be corresponding volume of an authorised 0.9% saline solution . The maintenance doses of the 0.9% saline solution to be infused 7 times will be given every 21 (+/-4) days.
16221782|NCT01225276|Drug|NewGam 10%|Loading dose at baseline (Week 0) will be 2.0 g/kg NewGam in all three NewGam treatment arms. The maintenance doses to be infused 7 times will be 1.0 g/kg every 21 (+/-4) days.
16221783|NCT01225276|Drug|NewGam 10%|Loading dose at baseline (Week 0) will be 2.0 g/kg NewGam in all three NewGam treatment arms. The maintenance doses to be infused 7 times will be 0.4 g/kg every 21 (+/-4) days.
16221784|NCT01225263|Drug|Simvastatin|simvastatin, 20 mg, twice daily for 6 months
16221785|NCT01225263|Dietary Supplement|Vitamin D|Vitamin D3, 1000 IU, twice daily for 6 months
16221786|NCT01225263|Other|Placebo|Two placebo pills, taken twice daily for 6 months
16221787|NCT01225250|Device|Polydioxanone (PDS) plates|0.5 mm PDS Flexible Plate made of poly-p-dioxanone, an aliphatic polyester which is manufactured by polymerization of the monomer p-dioxanone. Polydioxanone is a resorbable material degraded by hydrolysis and has been successfully used for bone discontinuities and septal reconstruction.
16221788|NCT01225250|Procedure|Caudal septal extension graft performed through endonasal rhinoplasty|The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure.
16221789|NCT01225250|Procedure|Caudal septal extension graft performed through endonasal rhinoplasty|The caudal septal extension (CSE) graft is a common method used to alter tip projection, alar-columellar relationship, and nasolabial angle.5 However, it can be difficult to stabilize and straighten the CSE graft, especially when performed through an endonasal approach. Use of a polydioxanone plate would provide a scaffolding for the CSE graft and could allow for a technically easier and more predictable surgical procedure.
16221790|NCT01225237|Drug|Ramosetron|oral
16221791|NCT01225237|Drug|Placebo|oral
16221792|NCT01225224|Drug|peficitinib|oral
16221793|NCT01225224|Drug|Placebo|oral
16221794|NCT01225211|Drug|Lumacaftor|Tablet
16221795|NCT01225211|Drug|Ivacaftor|Tablet.
16221796|NCT01225211|Drug|Lumacaftor Placebo|Matching placebo tablet.
16221797|NCT01225211|Drug|Ivacaftor Placebo|Matching placebo tablet.
16221798|NCT01225198|Dietary Supplement|Multi-Vitamin/Mineral Supplement|A broad-spectrum vitamin/mineral supplement designed for children and adults with autism
16221799|NCT01225198|Other|Liquid Placebo|The placebo was formulated to look and taste like the intervention supplement. A small amount of beta-carotene was used for coloring. Natural cherry, citric acid, and a proprietary blend of natural flavors were used for flavoring to create a vitamin-like after-taste. Sucralose was used as a sweetener and the same preservatives were included (potassium sorbate, sodium benzoate).
16221800|NCT01225172|Drug|BMS-754807|Tablet, Oral, 100 mg, Daily, Until disease progression or unacceptable toxicity
16221801|NCT01225172|Drug|letrozole|Tablets, Oral, 2.5 mg, Daily, Until disease progression or unacceptable toxicity
16221802|NCT01225159|Drug|TGC|TGC used hyperinsulinaemic normoglycaemic clamp with modified glucose-insulin-potassium to control blood sugar. The insulin (HumulinTM R, Lilly pharma, Germany) was diluted with normal saline to the concentration 1 IU. mL-1 and was infused continuously throughout the operations at a fixed rate of 0.3 IU. kg-1.h-1 but the maximal rate was 20 IU/ h. A separate mixture of glucose 25% (A.N.B Laboratories, Thailand) 50 mL, potassium chloride (Nida pharma, Thailand) 20 mEq and magnesium sulfate (Atlantic, Thailand) 2 gm was infused at 0.75 mL.kg-1.h-1 and was adjusted to maintain blood glucose levels 80-150 mg/dL.
16221803|NCT01225159|Drug|Conventional glycaemic control|Conventional glycaemic control aims to control blood sugar less than 250 mg%. Insulin was given bolusly if the blood sugar more than 250 mg%.
16221804|NCT01225146|Drug|ranibizumab|Ranibizumab is formulated as a sterile solution aseptically filled in a sterile 3-mL stoppered glass vial. Each vial contains 0.5 mL of 40 mg/mL (2.0-mg dose level) ranibizumab aqueous solution.
16221805|NCT01225133|Other|Complex Ayurvedic Treatment|In the Āyurveda group treatment will be individualized according to the Āyurveda diagnosis and include manual treatments, massages, dietary advice, specific consideration of selected food items, nutritional supplements, āyurvedic lifestyle and yoga posture advice and daily self-applied knee massage.
16221806|NCT01225133|Other|Conventional Care|Patients in the conventional standard care group will receive conventional standard care for OA of the Knee which includes self care advice, pain medication and intensified physiotherapy and follows the current international guidelines for OA of the knee.
16221807|NCT01225120|Other|Gait Training|12 sessions, 30 minutes of walking on treadmill with real time therapist directed feedback on gait kinematics.
16221808|NCT01225107|Dietary Supplement|Cranberry Extract|500mg TID
16221809|NCT01225107|Drug|Inert Placebo Capsule|Inert substance, 3 times per day in capsule form
16221850|NCT01224717|Drug|PTH134|
16221851|NCT01224717|Drug|Placebo|
16221852|NCT01224717|Drug|Forsteo|
16221810|NCT01225094|Drug|curcumin|Patients will take the study medication (500 mg x 4 capsules, twice daily [BID]) for two days leading up to repair, totaling 4000 mg per day. They will take a dose (2000 mg) the morning of repair, at the same time as regular medications not held for surgery. While they are on call to the operating room, they will take another dose of 2000 mg and then another 2000 mg dose 6 hours after the repair. Final dose is administered the morning after repair.
16221811|NCT01225094|Other|placebo|The placebo will look, smell, taste, and in every way be identical to the active drug. Patients will take the study medication in the exact same manner as the curcumin regimen.
16221812|NCT01225081|Drug|ipragliflozin|oral
16221813|NCT01225081|Drug|Placebo|oral
16221814|NCT01225081|Drug|Pioglitazone|oral
16221815|NCT01225068|Drug|Milnacipran|Total of 100 mg (50 mg twice a day) for 6 weeks. Option to increase to 200 mg (100 mg twice a day) after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
16221816|NCT01225068|Drug|Placebo|2 matching pills per day for 6 weeks. Option to increase dose after two weeks of treatment. Includes gradual escalation and discontinuation for week 1 and after week 6.
16221817|NCT01225055|Drug|Teriparatide|20 ug daily over 12 months
16221818|NCT01225055|Device|vibration|10 min/day for 12 months
16221819|NCT01225042|Dietary Supplement|probiotics|Freeze-dried powder, dose 10E9 CFU twice daily for 4 weeks
16221820|NCT01225042|Dietary Supplement|placebo|placebo consisting of carrier material powder of identical appearance
16221821|NCT01225029|Other|Amount of total fluids|Term neonates receive either total fluids of 60 mL/kg/day (standard) or 40 mL/kg/day (restricted) on day of life (DOL) 1. Preterm neonates receive total fluids of 80 mL/kg/day (standard) or 60 mL/kg/day (restricted) on DOL 1. Each group receives an extra 20 mL/kg/day daily until total fluids of 150 mL/kg/day are achieved.
16221822|NCT01225016|Drug|Definity contrast agent|Thyroid ultrasound using contrast agent
16221823|NCT01224990|Procedure|Whole body diffusion MRI|These studies will be performed on a 3Tesla (T) MR system (Achieva, Philips Medical Systems). A major advantage of 3T compared to 1.5 T is the improved signal to noise ratio that allows whole-body studies to be faster and without application of external antennas, which greatly improves patient comfort.
16221824|NCT01224977|Drug|azithromycin|azithromycin 500 mg 3/week for 3 months
16221825|NCT01224964|Drug|Montelukast|Montelukast, 10 mg
16221826|NCT01224964|Drug|long acting beta2 mimetic|ICS+long acting beta2 agonist: twice daily
16221827|NCT01224951|Drug|Beclomethasone|400 microgram of beclomethasone will be given to the patients in arm 1. During the last 4 weeks, the patients will receive additional 400 microgram of Qvar.
16221828|NCT01224925|Procedure|Direct pulp capping with Dycal|Capping over carious exposure with Dycal. Dycal: covered with Fuji IX. After one week, part of the temporary filling was left under the permanent filling
16221829|NCT01224925|Procedure|Direct pulp capping|WMTA capping over exposed pulp, wet pellet, Fuji IX. After one week, the entire temporary filling was removed,the cavity was permanently restored with a composite resin material used at the study clinic.
16221830|NCT01224912|Behavioral|Cognitive Behavioral Treatment|The techniques used throughout the self-help manual are all effective in reducing insomnia: 1) Stimulus control: patients should only go to bed when sleepy, use the bed and bedroom for sleep (and sex) only, maintain a regular rising time, avoid daytime naps and get out of bed and go into another room when unable to fall asleep within 15-20 minutes (return only when sleepy). 2) progressive muscle relaxation. 3) sleep hygiene education (improving health and environmental factors that affect sleep). 3). Sleep restriction, whereby participants will stay only the time in bed that they sleep. 4) cognitive therapy to challenge and dispute incorrect and unhelpful thoughts about sleep (e.g. I must sleep at least 8 hours, otherwise I'll be a wreck tomorrow).
16221831|NCT01224899|Procedure|Left cervico-thoracic sympathetic blockade|Left cervico-thoracic sympathetic blockade by videothoracoscopic clipping under general anesthesia and single-lumen orotracheal intubation in semi-sitting position.
16221832|NCT01224886|Behavioral|Physical activity|Supervised exercise intervention
16221833|NCT01224860|Drug|Telmisartan|One week 40 mg daily, followed by fifteen weeks treatment period with 80 mg daily.
16221834|NCT01224860|Drug|Losartan|One week 50 mg daily, followed by fifteen weeks treatment period with 100 mg daily.
16221835|NCT01224847|Drug|Tetracaine|1 gtt
16221836|NCT01224847|Drug|Cocaine|1 gtt
16221837|NCT01224847|Drug|Lidocaine|Lidocaine soaked pledget
16221838|NCT01224834|Drug|Sublingual tablet of ragweed pollen allergen extract|administered once a day over 10 days
16221839|NCT01224821|Biological|Tositumomab (Anti-B1 Antibody) and Iodine-131 Tositumomab|Patients receive a dosimetric dose consisting of 450 milligrams (mg) of unlabeled tositumomab (TST, Anti-B1 Antibody) intravenously (IV) followed by 5 milliCurie (mCi) of Iodine I 131 TST IV. Serial whole body sodium iodide probe scintillation counts and whole body conjugate view gamma camera scans obtained approximately 1 hour after administration and then daily for the next 7 days were used to determine the radioactive clearance and the dose of iodine I 131 TST required to deliver a 75 centigray (cGy) therapeutic dose. The therapeutic dose was administered 7-14 days after the dosimetric dose and consisted of TST 450 mg and an activity of Iodine 131 calculated to deliver 75 cGy or 65 cGy of total body irradiation, depending on platelet count, and 35 mg TST.
16221840|NCT01224808|Biological|Biostate|Single bolus doses, administered intravenously. Frequency and dose will be determined by the Investigator based on the subjects clinical condition, previous VWF concentrate requirements, response to therapy, weight and reason for usage.
16221841|NCT01224795|Drug|Peramivir|Adults (≥ 18 years): Peramivir 600 mg, administered intravenously. Adolescents (12 to < 18 years): Peramivir 10 mg/kg (not to exceed a maximum dose of 600 mg), administered intravenously.
16221842|NCT01224795|Drug|Placebo Comparator|Placebo Peramivir, administered intravenously.
16221843|NCT01224769|Drug|bendamustine +/- rituximab|
16221844|NCT01224756|Drug|Tinoridine HCl|Tinoridine HCl 50 mg, orally, 2 capsules three times daily for up to 4 days.
16221845|NCT01224756|Drug|Placebo|Tinoridine placebo-matching capsules, orally, 2 capsules three times daily for up to 4 days.
16221846|NCT01224743|Dietary Supplement|Blend 1|Blend 1 consists of a combination of Juice Plus+® Orchard (Fruit), Garden (Vegetable), and Vineyard (Berry) blends
16221847|NCT01224743|Dietary Supplement|Blend 2|Blend 2 consists of a combination of Juice Plus+® Orchard (Fruit) and Garden (Vegetable) blends
16221855|NCT01224678|Dietary Supplement|vitamin D|Given orally
16221856|NCT01224678|Other|placebo|Given orally
16221857|NCT01224665|Procedure|therapeutic conventional surgery|Patients undergo radical cystectomy
16221858|NCT01224665|Procedure|therapeutic standard lymphadenectomy|Patients undergo standard pelvic lymphadenectomy.
16221859|NCT01224665|Procedure|therapeutic extended lymphadenectomy|Patients undergo extended pelvic lymphadenectomy
16221860|NCT01224652|Drug|Paclitaxel|Paclitaxel, 70 mg/m2 will be administered as an intravenous (IV) infusion over 1 hour on Days 1, 8 and 15 of a 28-day cycle
16221861|NCT01224652|Drug|Irinotecan|irinotecan 150 mg/m2 will be administered as an intravenous (IV) infusion over 1 hour on Days 1 and 15 of a 28-day cycle
16221862|NCT01224639|Biological|TDV - Low Dose|TDV is a tetravalent dengue vaccine comprised of four recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. Low dose contains: TDV-1: 8 x 10^3 PFU, TDV-2: 5 x 10^3 PFU, TDV-3: 1 x 10^4 PFU, and TDV-4: 2 x 10^5 PFU, total virus per dose 2.2 x 10^5 PFU
16221863|NCT01224639|Biological|TDV - High Dose|TDV is a tetravalent dengue vaccine comprised of four recombinant, live attenuated dengue virus strains: TDV-1, TDV-2, TDV-3 and TDV-4. High dose contains TDV-1: 2 x 10^4 PFU, TDV-2: 5 x 10^4 PFU, TDV-3: 1 x 10^5 PFU, and TDV-4: 3 x 10^5 PFU, total virus per dose : 4.7 x 10^5 PFU. TDV administered intradermally.
16221864|NCT01224639|Biological|Placebo|Phosphate Buffered Saline (PBS)
16221865|NCT01224626|Drug|Zyvox (linezolid)|Patients should be treated with Zyvox (linezolid) 600 mg every twelve hours.
16221866|NCT01224613|Biological|Intanza|0.1 mL of Intanza intradermally at visit # 1
16221867|NCT01224613|Biological|Intanza|0.1 mL of Intanza intradermally at visit #1
16221868|NCT01224600|Other|patients with newly diagnosed PAD (<1year)|patients with newly diagnosed PAD (<1year) symptomatic or asymptomatic, without any history of previous coronary nor cerebrovascular event, and with no previous investigation of the aorta and cervical arteries were eligible
16221869|NCT01224587|Drug|D1000078|Oral, one single dose
16221870|NCT01224587|Drug|D1000082|Oral, one single dose
16221871|NCT01224587|Drug|D1000083|Oral, one single dose
16221872|NCT01224587|Drug|D1000085|Oral, one single dose
16221873|NCT01224561|Behavioral|Lipid overnutrition|During 4 months, the daily caloric intake will be increased by about 70 g fat as butter 20 grams, 100 grams of cheese (Emmental) and 40 grams of almonds. This overnutrition corresponds to an excess of 760 kcal / day or 21,280 calories for the period and then taken to a theoretical 2.4 kg of fat (1 kg fat = 9000 kcal).
16221874|NCT01224548|Other|vegan instruction and food accessibility|weekly 1-hr instructions including vegan nutritional information and cooking instructions. vegan menu will be made available at the cafeteria
16221875|NCT01224548|Other|control|no intervention in until June 2011. The control group start vegan diet in July 2011.
16221876|NCT01224535|Dietary Supplement|Maize and Amaranth|80g porridge per day, 5 days a week, for 16 weeks (4 months)
16221877|NCT01224522|Procedure|Visionaire|Implantation of a Genesis II Total Knee by means of Visionaire patient matched cutting blocks.
16221878|NCT01224522|Procedure|Standard surgical technique|Implantation of Genesis II Total Knee system by means of standard surgical technique.
16221879|NCT01224509|Drug|Mifepristone|Administration of 200 mg of mifepristone orally 48 hours prior to a cervical biopsy and evacuation by dilatation and curettage of the endometrial cavity
16221880|NCT01224509|Other|Non-treatment|Non-treatment prior to a cervical biopsy and evacuation by dilatation and curettage of the endometrial cavity
16221881|NCT01224496|Drug|Chinese herbal concoction twice a day for 6 months|Definition of each TCM syndrome is based on TCM theory. Formulation composition is based on each defined TCM syndrome with addition or removal of herbs as indicated by the patient's manifestation
16221882|NCT01224470|Drug|Dexmedetomidine|Dexamedetomidine intravenous injection (1 ㎍/kg )
16221883|NCT01224457|Drug|Phenobarbital|phenobarbital 20mg/kg iv infusion, after 24hours of loading, 2.5mg/kg bid daily
16221884|NCT01224444|Other|standard polypectomy snare|Electrocautery snare resection of sessile colonic polyps
16221885|NCT01224431|Drug|Buffered Lidocaine J-tip|All patients were administered the J-tip and randomized to either treatment with 1% lidocaine or an equivalent amount of sterile normal saline prior to lumbar puncture. Vital signs were recorded during the procedure. Facial expressions were video recorded
16221886|NCT01224418|Drug|Tacrolimus|oral
16221887|NCT01224405|Drug|Docetaxel + LH-RH analogues|"Docetaxel will be administered at a dose of 75 mg/m2 per square meter as a 1-hour intravenous infusion on day 1 every 21 days in association to 5 mg of prednisone orally twice daily.
~In patients randomised to arms A up to 10 cycles of docetaxel will be planned in association to maintenance of LH-RH analogues administration."
16221888|NCT01224405|Drug|Docetaxel|"Docetaxel will be administered at a dose of 75 mg/m2 per square meter as a 1-hour intravenous infusion on day 1 every 21 days in association to 5 mg of prednisone orally twice daily.
~In patients randomised to arms B up to 10 cycles of docetaxel will be planned, in association to stopping LH-RH analogues."
16221889|NCT01224405|Drug|Docetaxel|Patients randomised in the arms AB1 (intermittent docetaxel) will suspend treatment after at least 4 cycles if their PSA level will be reduced >50%. Docetaxel treatment will be resumed when the serum PSA will rise by >50% from the lowest PSA level recorded and will be >10 ng/mL or when there will be other evidence of disease progression. PSA progression must to be confirmed with a second assessment after 2 weeks before deciding to resume docetaxel administration.
16221890|NCT01224405|Drug|Continuous Docetaxel|Patients randomised in the arms AB2 (continuous docetaxel) will continue treatment up to ten cycles after even if their PSA level at 4 cycles will be reduced >50% or will reach a level <4 ng/mL.
16221891|NCT01224405|Drug|Continuous Docetaxel|Patients randomised in the arms AB1(intermittent docetaxel) will continue treatment up to ten cycles even if their PSA level after 4 cycles will be reduced >50% or will reach a level <4 ng/mL.
16221892|NCT01224392|Other|Chemoradiotherapy|Radiotherapy (23 x 2 Gy) + capecitabine 825mg/m2 p.o. twice daily, excluding weekends
16221893|NCT01224392|Radiation|Radiotherapy with boost|Radiotherapy (23 x 2 Gy), with a simultaneous integrated boost up to 55.2 Gy on the primary tumor
16221894|NCT01224379|Device|Topping off system|"The intervention group will receive a topping off system (PLIF -posterior intervertebral fusion- connected with a flexible pedicle screw system above the fusion)."
16221895|NCT01224379|Device|monosegmental PLIF|The control group receives a monosegmental PLIF. This is the current standard therapy for many pathologies in the lumbar spine (e.g. Spondylolisthesis)
16221896|NCT01224366|Drug|Vildagliptin|
16221897|NCT01224366|Drug|Placebo|
16221898|NCT01224353|Drug|lipoic acid|Tablet, 600mg, for oral use, 30 min before breakfast, once daily for 6 weeks
16221899|NCT01224353|Other|Placebo|Tablet, placebo, 1-week single-blind placebo treatment then, 30 min before breakfast, once daily for 6 weeks
16221900|NCT01224340|Behavioral|lollipop|The lollipops varied in color and each color had its own flavor. The children chose between blue, green, red, orange or yellow lollipop colors. The children started to taste the lollipops approximately three to five minutes before the wound care and continued to do so during the whole session.
16221901|NCT01224340|Behavioral|serious games|The serious game chosen, Tux Racer, contented a penguin that collected fishes at the same time as it did slalom in a path.
16221902|NCT01224340|Other|control|The participants in the control group were offered standard care without any specific distraction techniques, except consolation by the acting staff.
16221903|NCT01224327|Biological|umbilical cord Mesenchymal Stem Cells|Umbilical cord mesenchymal stem cells were infused to patients using interventional method via hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography,umbilical cord MSCs were infused slowly for 15-20minutes.
16221904|NCT01224327|Drug|Conserved therapy|Oral or intravenous administration
16221905|NCT01224314|Other|Changing potassium concentration in dialysis fluids|The dialysis sessions was divided into 3 tertiles, casually modulating potassium concentration in the dialysate between the value normally used K and the two cut-off points K+1 and K-1 mmol/l
16221906|NCT01224301|Behavioral|School based flu vaccine: Low intensity|Interventions: Parents of children in Low Intensity Notification schools got less than 3 communications from schools describing influenza vaccine and the clinics, and consent forms sent home one.
16221907|NCT01224301|Behavioral|School based flu vaccine: High intensity|Interventions: Parents in high intensity schools have 3 or more communications from schools about influenza illness, influenza vaccine, and school based clinics.
16221908|NCT01224288|Procedure|Perfusion CT scan|DCE-CT scans 4 weeks prior to and 8 weeks after starting treatment on study 2010-0085.
16221909|NCT01224275|Other|group based care|Midwives is randomized and allocated to group based antenatal care. The midwives have a manual for the model of care.
16221910|NCT01224262|Biological|Fluzone® (2010/2011 Inactivated Trivalent Influenza Vaccine)|A single vaccination of Fluzone alone
16221911|NCT01224262|Biological|LIQ001 (0.45mg)|A single vaccination of 0.45 mg LIQ001
16221912|NCT01224262|Biological|LIQ001 (1.8mg)|A single vaccination of 1.8 mg LIQ001
16221913|NCT01224249|Dietary Supplement|Fish and shellfish|Intake of 1000 grams of fish and shellfish per week for six months.
16221914|NCT01224236|Drug|Iron Supplement|2 mg/kg/day elemental iron as multivitamin with iron solution
16221915|NCT01224236|Drug|control|multivitamin solution without iron
16221916|NCT01224210|Drug|Ambrisentan|Ambrisentan once-daily in the morning with or without food. The adult dose selected for this study will be 5 mg for the first 4 weeks. After the initial 4 weeks the dose will be increased to 10mg (available doses are 5, and 10 mg) based on tolerance safety. Subjects will remain on 10mg until they complete the study. Dose adjustments may be made based on side effects.
16221917|NCT01224197|Drug|TMC435|100 or 200 mg capsule, one single dose
16221918|NCT01224197|Drug|TMC435|100 or 200 mg capsule, once daily for 5 days
16221919|NCT01224184|Behavioral|Young Women's CoOp|Participants in this group will participate in three individual sessions and one group session of the young woman-focused intervention about HIV/STIs, pregnancy, alcohol and other drug use, violence, gangs and other issues. This intervention is an adaptation of the evidence-based Women's CoOp (PI: Dr. Wendee M. Wechsberg).
16221920|NCT01224184|Behavioral|Staying Healthy and Eating Well|Participants in this group will participate in three individual sessions and one group session of the nutrition intervention about healthy eating, physical activity and general wellness.
16221921|NCT01224171|Drug|vedolizumab|Vedolizumab for intravenous infusion
16221922|NCT01224171|Other|Placebo|Placebo intravenous infusion
16221923|NCT01224158|Device|Experimental Power Toothbrush|Following a placebo mouthwash phase, Subjects will be asked to brush their teeth (twice per day with the experimental toothbrush and toothpaste provided) moving to the next quadrant of the mouth at 30-second intervals.
16221924|NCT01224158|Device|Flat trimmed Manual Toothbrush|Following a placebo mouthwash phase, Subjects will be asked to brush their teeth (twice per day using the toothbrush and toothpaste provided) in their usual manner.
16221925|NCT01224145|Drug|5x5cm bupivacaine collagen sponges|
16221926|NCT01224132|Drug|probiotic ® pur|daily, four types of probiotic bacteria ( Bifidobacterium bifidity, Lactobacillus acidophilus, Lactobacillus casei and Lactobacillus salivarium) 2 bags (two billion bacteria) (probiotic ® pur) for a total of 8 (eight) weeks
16221927|NCT01224119|Device|Amplex|225 micrograms of B2A per cc of ceramic granules
16221928|NCT01224119|Procedure|Autograft bone|Bone is collected through a separate incision at the iliac crest or tibia.
16221929|NCT01224106|Drug|Gantenerumab|Participants will receive gantenerumab at 105 mg , 225 mg, or at doses up to 1200 mg SC injection q4w.
16221930|NCT01224106|Drug|Placebo|Participants will receive placebo SC injection q4w.
16221931|NCT01224093|Drug|Chemotherapy|as prescribed
16221932|NCT01224093|Drug|rituximab [MabThera/Rituxan]|as prescribed
16221933|NCT01224080|Device|Adiana placement|All patients will undergo the Adiana Tubal Occlusion procedure. This procedure will be done in an office based setting and last approximately 1 hour.
16221934|NCT01224067|Drug|Quetiapine|Adjunctive quetiapine -Participant will receive up to 300 mg/day of quetiapine for 8 weeks.
16221935|NCT01224041|Drug|Tacrolimus|oral
16221936|NCT01224028|Drug|Tacrolimus|oral
16221937|NCT01224028|Drug|Placebo|oral
16221938|NCT01224015|Drug|normal saline|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.
16221939|NCT01224015|Biological|onabotulinumtoxinA 44 U|44 units onabotulinumtoxinA (botulinum toxin type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.
16221940|NCT01224015|Biological|onabotulinumtoxinA 24 U|24 units onabotulinumtoxinA (botulinum toxin type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients may receive up to 2 treatments during the study.
16221941|NCT01223989|Other|hypocaloric diet balanced + nutrition education + ruled physical activity|
16221942|NCT01223976|Other|Tuberculin skin test and Quantiferon -TB Gold test|"TST A 2-TU dose of PPD will bevadministered by a certified technician using the Mantoux method and induration measured after 72 h.
~QFT-G test The second-generation QuantiFeron® (QIFN) whole-blood IFN assay (Cellestis) will be performed and interpreted according to the manufacturer's instructions."
16221943|NCT01223937|Drug|Desmopressin|
16221944|NCT01223937|Drug|Placebo|
16221945|NCT01223924|Other|placebo|placebo
16221946|NCT01223924|Drug|M2ES|M2ES IV 7.5mg-90mg
16221947|NCT01223911|Drug|NNC 0151-0000-0000|Multiple doses will be administered subcutaneously (under the skin), one dose once weekly during a three week period
16221948|NCT01223911|Drug|placebo|Multiple doses will be administered subcutaneously (under the skin), one dose once weekly during a three week period
16221949|NCT01223898|Drug|Tasigna|
16221950|NCT01223885|Dietary Supplement|Camel's milk|Patients with proved cow's milk allergy who have negative prick skin tests to came's milk will be administered gradually increased doses of pasteurized camel's milk at 30 minute intervals
16221951|NCT01223872|Other|interview|"Standard Interview (2-15 years from last treatment)
~Demographic data interview (pre-initial study interview)"
16221952|NCT01223872|Other|clinic visit and interview|"REACH Clinic Visit(initial or regular)
~Post-REACH Clinic Interview (3mos from initial or regular clinic visit)
~Demographic data interview(pre-initial study interview)"
16221953|NCT01223872|Other|interviews and clinic visit|"Pre-REACH Clinic Interview(2-15 yrs from last treatment)
~REACH Clinic Visit(initial or regular)
~Post-REACH Clinic Interview(1mo from initial clinic visit)
~Post-REACH Clinic Interview(3mos from initial or regular clinic visit)
~Demographic data interview(pre-initial study interview)"
16221954|NCT01223859|Procedure|Interstitial soft palate surgery|Soft palate RF surgery in local anaesthesia
16221955|NCT01223820|Drug|Capsaicin|5x nasal application in one day, 1 hour between each application
16221956|NCT01223807|Other|Diaphragmatic breathing training|The training group will participate in a diaphragmatic breathing program which will consist of three 45-min sessions each week (12 sessions totally). The program training will be individualized and supervised by the same physiotherapist. In each session, the patients will be initially instructed to perform 3 series of 10 maximally inspirations, predominantly with abdominal motion, while reducing upper rib cage motion in a supine position.
16221957|NCT01223781|Behavioral|Biofeedback-based motor learning for PD|Prior to freezing episodes, auditory stimulation is triggered
16221958|NCT01223768|Drug|Acetyl-l-Carnitine|2g per day
16221959|NCT01223768|Drug|placebo|twice per day
16221960|NCT01223755|Drug|Sirolimus|Patients will be given SRL for one year starting at the oral daily dose of 3 mg, with periodical whole blood level measurements. The daily dose will be adjusted to keep SRL concentration within 5-10 ng/ml. Drug levels will be assessed at day 7 after starting treatment and every two weeks for the first month. Subsequently SRL concentrations will be monitored at monthly intervals (or at least 5 days after drug dose adjustments) until the end of the treatment period.
16221961|NCT01223755|Drug|conventional therapy|Conventional treatment relates usually to the administration of antihypertensive drugs for patients with high blood pressure. Thus, for the present study, no major change in antihypertensive treatment should be introduced throughout the whole study period unless deemed clinically necessary (the reasons of the changes should be, however, clearly explained in the CRF). Only small changes in the doses of the ongoing treatments are recommended in order to maintain the same level of blood pressure control (target systolic/diastolic blood pressure <130/80 mmHg). This approach is aimed to minimize the confounding effect of any change in concomitant treatments on some efficacy variables (such as urinary protein excretion rate).
16221962|NCT01223742|Dietary Supplement|ACETYL-L-CARNITINE|2 g acetylcarnitine taken orally twice a day.
16221963|NCT01223742|Drug|placebo|placebo twice per day
16221964|NCT01223729|Drug|Acetyl-L-Carnitine|2 g acetyl-L carnitine twice a day
16221965|NCT01223729|Other|placebo|placebo twice per day
16221966|NCT01223716|Behavioral|Perceptual learning|Research participants will be asked to practice a visual discrimination task (e.g. position acuity, contrast sensitivity, stereoacuity etc) in our laboratory for a period of time (2 hrs/day, 5 days/week).
16221967|NCT01223716|Behavioral|Video Game|"Research participants will be asked to play off-the-shelf video games in our laboratory for a period of time (2 hrs/day, 5 days/week)."
16221968|NCT01223716|Behavioral|Crossover (Occlusion therapy + Video Game)|"Phase 1. Research participants will be required to cover the good eye during the day in order to push the brain to use the amblyopic eye (2 hrs/day, 5 days/week for 2-4 weeks).
~Phase 2. Research participants will be required to cover the good eye during the day in order to push the brain to use the amblyopic eye (2 hrs/day, 5 days/week for 2-4 weeks)."
16221969|NCT01223703|Drug|n-3 PUFAs|1.0 g gelatin capsules containing 850 to 882 mg of EPA and DHA ethyl esters in the average ratio EPA/DHA of 0.9:1.5 The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study.
16221970|NCT01223703|Drug|Placebo|1.0 g gelatin capsules containing olive oil. The treatment dose was five capsules daily for the first month followed by two capsules daily for the rest of the study
16221971|NCT01223690|Drug|Clarithromycin|1000 mg diluted into 250 ml of dextrose 5% administered intravenously within one hour of continuous infusion for four consecutive days
16221972|NCT01223690|Drug|Dextrose 5%|1000 mg diluted into 250 ml of dextrose 5% administered intravenously within one hour of continuous infusion for four consecutive days
16221973|NCT01223677|Behavioral|Rumination Focused CBT|see arms
16221974|NCT01223664|Procedure|Allogenic bone marrow stem cells transplantation|30ml allogenic bone marrow stem cells were infused to patients using interventional method via portal vein or hepatic artery as well as conserved therapy
16221975|NCT01223664|Drug|Conserved therapy|Oral or intravenous administration
16221976|NCT01223651|Procedure|two step hyperinsulinaemic glucose clamp study.|Study participants will have their blood glucose stabilized between 5 - 6 mmol/L by the delivering of a controlled rate insulin/glucose infusion. Participants will have their blood glucose level reduced by conducting a controlled two step hyperinsulinaemic glucose clamp. The clamp procedure will take a total of 120 minutes and will reduce the blood glucose level to below 3 mmol/L. During this time blood tests will be obtained for analysis, physical observations recorded and cognitive function tests performed at regular intervals. Participants will have been fitted at least 12 hours prior to the intervention with 2 real time continuous glucose monitoring systems which will remain in place for the duration of the clamp procedure, however participants will be blinded to their glucose readings.
16221977|NCT01223638|Other|Audiometry|Audiometry
16221978|NCT01223625|Drug|Rosuvastatin 5mg/day|Rosuvastatin 5mg/day
16221979|NCT01223625|Drug|Rosuvastatin 40mg/day|Rosuvastatin 40mg/day
16221980|NCT01223612|Drug|Ranibizumab|Intravitreal injection of 0.5mg in 0.05ml. One injection at baseline, 4 and 8 weeks then four-weekly as required to 44 weeks.
16221981|NCT01223612|Procedure|Modified ETDRS laser|Argon laser therapy to the macula in accordance with the modified ETDRS protocol at baseline, 12, 24 and 36 weeks.
16221982|NCT01223560|Drug|Insulin Aspart|Insulin bolus with and without carbohydrate intake.
16221983|NCT01223560|Other|Exercise|Exercise on tread mill
16221984|NCT01223560|Dietary Supplement|Carbohydrate|Carbohydrate intake
16221985|NCT01223547|Other|Education|Participants are taught the principles of carb counting
16221986|NCT01223547|Other|Education|Participants are taught the principles of carb counting and the use of the integrated glucose meter and bolus calculator.
16221987|NCT01223534|Drug|Preventive treatment with Isoniazid.|If TST positive: participant will be treated with Isoniazid 300 mg/d, for 6 months.
16221988|NCT01223534|Drug|Preventive treatment with Isoniazid|If QFT-IT positive, Isoniazid 300 mg/d, for 6 months.
16221989|NCT01223521|Device|Immediate intrauterine contraception|A Cu-IUD or LNG-IUS is inserted after abortion.
16221990|NCT01223469|Device|Contact force assisted irrigated RF ablation|radiofrequency ablation of atrial fibrillation or SVT
16221991|NCT01223443|Device|Paclitaxel eluting stent|Patients are randomized to either stenting the moderate SVG lesion with the paclitaxel stent or standard medical treatment
16221992|NCT01223430|Drug|Si-Ni-Tang/ Placebo of Si-Ni-Tang|The prescription is 2.25 grams four times a day ( 9 grams per day) for 7 days or till shock reversal( if shock reversal < 1 week). Shock reversal was defined as the discontinuation of norepinephrine or dopamine lasting for at least 24 hours.
16221993|NCT01223404|Drug|Placebo|Participants are administered a placebo patch and a placebo capsule
16221994|NCT01223404|Drug|Nicotine|Participants are administered a nicotine patch (7 mg/24 hrs) and a placebo capsule
16221995|NCT01223404|Drug|Mecamylamine|Participants are administered a placebo patch and a capsule containing 7.5 mg of mecamylamine
16221996|NCT01223391|Other|Abdominal binder|External abdominal compression sequentially applied at 20 mmHg for 3 minutes, maximal tolerable level for 1.5 minutes and comfortable level for 2 minutes.
16221997|NCT01223391|Other|No abdominal binder|Standing without abdominal binder for 3 minutes
16221998|NCT01223378|Drug|BOL-303259-X|ophthalmic solution, various concentrations, once daily (QD) 28 days
16221999|NCT01223378|Drug|Latanoprost|0.005% ophthalmic solution, QD 28 days
16222000|NCT01223365|Drug|Hydrocodone ER|Hydrocodone bitartrate extended-release tablets were administered at doses of 15, 30, 45, 60, and 90 mg orally every 12 hours. During the open-label titration period, doses were adjusted until a stable pain control was achieved. In general, the dose of hydrocodone extended release tablets could be adjusted for efficacy or tolerability, as necessary, at any time during the open-label treatment period; however, participants were required to visit the study center before increasing the dose of study drug.
16222001|NCT01223352|Drug|bosentan|32 mg quadrisected dispersible tablet. The dosage of bosentan (2 mg/Kg) was adjusted according to the patient's body weight at initiation of the study treatment. Dosage readjustment was permitted after 12 weeks of treatment.
16222002|NCT01223339|Drug|Ertugliflozin|Dose escalation of 1, 5, and 25 mg Ertugliflozin administered in the fasted state
16222003|NCT01223339|Drug|Placebo|Placebo tablets to Ertugliflozin administered in the fasted state
16222004|NCT01223339|Drug|Ertugliflozin|Ertugliflozin 25 mg tablets administered once daily in the fed state for 7 days
16222005|NCT01223339|Drug|Placebo|Placebo tablets administered once daily in the fed state for 7 days
16222006|NCT01223326|Drug|Acetylcysteine (NAC)|NAC 150 mg/Kg; and infusion of 50 mg/kg, from 30 minutes before the ischemia up to 60 minutes later to the reperfusion
16222007|NCT01223326|Drug|Saline|Na Cl 0.9% infusion
16222008|NCT01223313|Device|Woman's Condom|The Woman's Condom (WC) is an investigational device manufactured by Shanghai Dahua Medical Apparatus Corp., Ltd (Dahua). Dahua's quality management system complies with ISO9001:2000, ISO13485:2003, MDD93/42/EEC. The WC consists of a 0.03-mm-thick pliable plastic pouch that easily conforms to the shape of the vagina. It is 22.9 cm (± 0.3 cm)(9 inches ± 0.1 inch) long and has a flexible soft outer ring that is designed to hug the external genitalia. The foam shapes on the outside of the pouch cling lightly to vaginal walls, ensuring stability of the device. The insertion capsule is made from dissolvable polyvinyl alcohol (PVA) and is similar to the PVA used in C-Film (Apothecus Pharmaceutical Corporation, New York, NY). The WC is a non-lubricated device. It is supplied with water-soluble lubricant with a chemical composition similar to a commercially available lubricant used in previous studies of the WC. Women will receive instruction sheets on the use of the WC and lubricant.
16222009|NCT01223274|Device|CPAP/PEEP|Infants received 100% oxygen by facemask and continuous positive airway pressure (CPAP) or positive pressure ventilation (PPV) with positive end-expiratory pressure (PEEP), if the infant required PPV.
16222010|NCT01223274|Device|Standard management practices|Control infants were treated with 100% oxygen and no CPAP. When a control infant required PPV, no PEEP was used.
16222039|NCT01223001|Drug|Duloxetine|Duloxetine 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
16222040|NCT01223001|Drug|Sugar pill|Sugar pills 30 mg. PO daily to 120mg. PO daily for nine months in patients who have suffered a traumatic brain injury at least six months previously.
16222041|NCT01222988|Dietary Supplement|Optifast Products|Optional Optifast products offered once every other week X 6 months; then monthly.
16222011|NCT01223248|Radiation|IGIMRT using a single dose of 24 Gy|Pts in both the hypofractionated & single dose arms will receive the same following standard procedures. The only difference between the arms is the dose delivered at each treatment. 20 MSKCC pts (10 per treatment arm) will be accrued to undergo baseline DW-MRI & DCE-MRI pretreatment for both arms & 1 hour after their initial treatment for single fraction pts, & within one hour of their initial & final radiation treatment for the hypofractionated pts. Pts will be considered for this scan based on compliance to scan schedule & MRI availability for performing the scan within one hour of the planned IGRT. 24 MSKCC pts (12 per treatment arm) will be accrued for the blood collection (optional) up to 4 hours prior, 50-90 minutes after, & approximately 24 hours [MCPG2.3]after treatment for single fraction pts. For pts partaking in both sub-studies, the post-treatment blood collection may be done in a 50-120 minute window to account for scheduling conflicts with the research MRI.
16222012|NCT01223248|Radiation|IGIMRT 27 Gy in 3 fractions|Pts in both the hypofractionated & single dose arms will receive the same following standard procedures. The only difference between the arms is the dose delivered at each treatment. 20 MSKCC pts (10 per treatment arm) will be accrued to undergo baseline DW-MRI & DCE-MRI pretreatment for both arms & within 1 hour after their initial treatment for single fraction pts, & within one hour of their initial & final radiation treatment for the hypofractionated pts. Pts will be considered for this scan based on compliance to scan schedule & MRI availability for performing the scan within one hour of the planned IGRT. 24 MSKCC pts (12 per treatment arm) will be accrued for the blood collection (optional) up to 4 hours prior, 50-90 minutes after, & approximately 24 hours [MCPG2.3]after treatment for single fraction pts. For pts partaking in both sub-studies, the post-treatment blood collection may be done in a 50-120 minute window to account for scheduling conflicts with the research MRI.
16222013|NCT01223235|Biological|bevacizumab and the polyvalent vaccine-KLH conjugate + OPT-821|A maximum of 6 doses of the polyvalent-KLH vaccine and OPT-821 will be administered to each patient as per the schedule. Bevacizumab will be administered once every two weeks until week 11 and then once every three weeks according to the schedule. When the 6 vaccinations of the polyvalent-KLH vaccine +OPT821 are completed, patients may still continue to receive bevacizumab on the once every three week schedule.
16222014|NCT01223222|Drug|LTX-109|Topical administration. 3 times daily. 5 days.
16222015|NCT01223209|Drug|LTX-315|0.25-2.0 mg/ML, maximum 5 injections during 36 days.
16222016|NCT01223196|Drug|Pioglitazone|This study will examine the effect of Pioglitazone on tissue inhibitor of metalloproteinases (TIMP-3) and on TNF-alfa converting enzyme in the skeletal muscle of type 2 diabetic subjects.
16222017|NCT01223196|Drug|Placebo|Inactive placebo for comparison to Pioglitazone on tissue inhibitor of metalloproteinases (TIMP-3) and on TNF-alfa converting enzyme in the skeletal muscle of type 2 diabetic subjects.
16222018|NCT01223183|Drug|hypertonic saline (7%)|single treatment by inhalation
16222019|NCT01223183|Drug|isotonic saline|single treatment by inhalation
16222020|NCT01223170|Behavioral|Tailored content|Participants will have access to content tailored for Stage of Change, Regulatory Focus and Self-Efficacy.
16222021|NCT01223170|Behavioral|Generic Internet-based information|Access to a website with general information about Cardiovascular Disease and self-management, including diet, physical activity, smoking and medications.
16222022|NCT01223170|Behavioral|Discussion forum|Access to a discussion forum for Cardiovascular Disease Rehabilitation.
16222023|NCT01223170|Behavioral|Behavioral monitoring|Participants will be offered behavioral monitoring, based on data collected from online self-reports and from activity sensors built into mobile phones.
16222024|NCT01223157|Biological|Biological data|Height, Weight, waist circumference and systolic and diastolic blood pressure will be measured in obese and normal subjects. Blood and saliva sampling will be performed after an overnight fast, one hour and just before the beginning of the lunch and one hour after the end of the lunch. This will allow a measurement of fasting glycaemia and insulin, fasting cholesterol and triglycerides, liver profile. Endocannabinoids will be measured both in plasma and saliva at each time point. Gut hormones (Ghrelin and PYY) will be measured before, just before and after lunch in plasma.
16222025|NCT01223144|Behavioral|Iowa Gambling Task and Ekman facial recognition test|"Iowa Gambling Task: mean number of cards chosen from decks with low (A+B) and high gain (C+D).
~Ekman facial recognition test: mean number of faces correctly recognized (60 images with 6 different expressions: happiness, sadness, fear, surprise, disgust and anger)."
16222026|NCT01223131|Drug|Insulin glargine (HOE901)|"Pharmaceutical form:aqueous solution for injection
~Route of administration: Subcutaneous"
16222027|NCT01223131|Drug|NPH insulin|"Pharmaceutical form:aqueous solution for injection
~Route of administration: Subcutaneous"
16222028|NCT01223118|Procedure|Vitrification and PGD|Half of the oocytes retrieved from each patient will undergo vitrification, immediate thaw and insemination. All embryos will undergo biopsy for PGD prior to transfer.
16222029|NCT01223105|Procedure|slow freeze|Eggs will be placed in a cryo-protected solution and frozen slowly in a programable freezer
16222030|NCT01223105|Procedure|Vitrification|Eggs will be placed in a high concentration of cryo-protectant and frozen very quickly by plunging in liquid nitrogen
16222031|NCT01223079|Drug|r-hFSH|r-hFSH dose to be determined by the patient's primary doctor and adjusted according to their response
16222032|NCT01223079|Drug|r-hFSH and r-hLH|Patients will begin r-hLH at 300IU/day when there are 2 follicles greater than or equal to 14mm.
16222033|NCT01223053|Drug|Ketoprofen 10% cream|100 mg (10%) in 1 gram of topical cream applied three times per day for 7 days. Safety follow up on day 14.
16222034|NCT01223053|Drug|Placebo|Matching placebo cream containing identical constituents as the active comparator except for ketoprofen
16222035|NCT01223040|Other|SYSTANE® Balance Lubricant Eye Drops|Subjects will be dosed (bilaterally) in the office during each visit. Between visits 2 and 3, patients will dose 4 times per day for the 7 day period.
16222036|NCT01223027|Drug|Dovitinib|Dovitinib is formulated as an oral gelatin capsule of 100 mg strength and was dosed on a flat scale of 500 mg on a 5 days on/2 days off dosing schedule. Medication labels complied withthe legal requirements of each country and were printed in the local language.
16222037|NCT01223027|Drug|Sorafenib|Sorafenib is formulated as a round, oral, biconvex, red film-coated tablet that contains 200 mg of sorafenib (tosylate). Sorafenib was administered twice daily without food at least 1 hour before or 2 hours after a meal. Sorafenib was supplied according to local practice.
16222038|NCT01223014|Drug|AZD2423|AZD2423
16222043|NCT01222962|Drug|Eurartesim|Tablet containing 40 mg of Dihydroartemisinin (DHA) and 320 mg of Piperaquine phosphate (PQP). 4 Tablets a Day for body weight above 75 kg.
16222044|NCT01222949|Drug|Eurartesim|Tablet containing 40 mg of Dihydroartemisinin (DHA) and 320 mg of Piperaquine phosphate (PQP). 3 Tablets a Day for body weight comprised between 36 and 75 kg, 4 tablets for body weight above 75 kg.
16222045|NCT01222936|Drug|LBH581|25 mg/5 ml solution packaged in 6 ml type I glass vials and given as a 30 minutes infusion at the dose of 20 mg/m2 i.v., on day 1 and 8, every 21 days.
16222046|NCT01222923|Drug|Risperidone|1 mg orally disintegrating tablets
16222047|NCT01222910|Drug|Valacyclovir hydrochloride|
16222048|NCT01222897|Drug|Valacyclovir hydrochloride|
16222049|NCT01222884|Drug|Monofer|Iron isomaltoside 1000 (Monofer®) administered as 500 mg intravenous single bolus injection over approximately 2 minutes
16222050|NCT01222884|Drug|Iron sucrose|Iron sucrose is administered undiluted in doses of 100mg at baseline, 200mg at week 2 and 200 mg at week 4 as fractionated IV bolus injections according to local Summary of Product Characteristics
16222051|NCT01222871|Drug|Triamcinolone|Triamcinolone soaked nasopore dressing
16222052|NCT01222871|Drug|Saline soaked sponge|saline soaked sponge
16222053|NCT01222858|Behavioral|Diet and Activity Education|Education about behavioral modification of eating and activity habits for weight loss.
16222054|NCT01222858|Behavioral|Self-monitoring with Feedback|Participants self-monitor diet and activity behaviors, which are submitted via a website. Automated feedback on the self-monitoring record is provided to participants.
16222055|NCT01222845|Drug|Test meal|Porridge made from rolled, or pinhead oats providing 50 g of carbohydrate
16222056|NCT01222832|Drug|Bacitracin|Bacitracin soaked nasopore sponge
16222057|NCT01222819|Drug|filgrastim|5 mcg/kg (rounded to 300 mcg or 480 mcg)
16222058|NCT01222806|Device|Repetitive Transcranial Magnetic Stimulation|
16222059|NCT01222780|Drug|Marqibo|Marqibo® intravenously (IV) over 60 minutes (+ 10 minutes) every 7 days (+ 3 days) for 4 consecutive weeks (day 1, 8, 15, 22) for a 28-day treatment cycle
16222063|NCT01222715|Biological|Bevacizumab|Given IV
16222064|NCT01222715|Drug|Cyclophosphamide|Given IV
16222065|NCT01222715|Other|Laboratory Biomarker Analysis|Correlative studies
16222066|NCT01222715|Drug|Temsirolimus|Given IV
16222067|NCT01222715|Drug|Vinorelbine Tartrate|Given IV
16222068|NCT01222702|Drug|Cadazolid|Cadazolid, provided as powder (250 mg, 500 mg or 1000 mg) to be reconstituted as a suspension prior to oral administration
16222069|NCT01222702|Drug|Vancomycin|Vancomycin, provided as capsules (125 mg) for oral administration
16222070|NCT01222702|Drug|Placebo-matching cadazolid|Placebo of cadazolid powder for oral suspension
16222071|NCT01222702|Drug|Placebo-matching vancomycin|Placebo of vancomycin capsules
16222072|NCT01222689|Drug|erlotinib hydrochloride|Given PO
16222073|NCT01222689|Drug|selumetinib|Given PO
16222074|NCT01222689|Other|laboratory biomarker analysis|Correlative studies
16222075|NCT01222676|Drug|cisplatin|
16222076|NCT01222676|Drug|gemcitabine hydrochloride|
16222077|NCT01222676|Drug|sorafenib tosylate|
16222078|NCT01222676|Other|imaging biomarker analysis|
16222079|NCT01222676|Other|laboratory biomarker analysis|
16222080|NCT01222676|Procedure|computed tomography|
16222081|NCT01222676|Procedure|neoadjuvant therapy|
16222082|NCT01222676|Radiation|fludeoxyglucose F 18|
16222083|NCT01222663|Device|standard therapy|Standard therapy in the ICU including but not limited to: antibiotic therapy, nutrition, fluid challenge, vasopressors, hemodynamic monitoring, organ support in the ICU including mechanical ventilation, renal replacement therapy when appropriate
16222084|NCT01222663|Device|hemoperfusion|Extracorporeal hemoperfusion with Toraymyxin PMX-20R and conventional medical therapy in the ICU including but not limited to: antibiotic therapy, nutrition, fluid challenge, vasopressors, hemodynamic monitoring, organ support in the ICU including mechanical ventilation, renal replacement therapy when appropriate.
16222085|NCT01222650|Drug|KSO-0400|
16222086|NCT01222650|Drug|KSO-0400|
16222087|NCT01222650|Drug|Silodosin|
16222088|NCT01222650|Drug|Placebo|
16222089|NCT01222637|Drug|CetuGEX™|
16222090|NCT01222624|Drug|PankoMab-GEX™|
16222091|NCT01222611|Drug|Fosamprenavir|HAART including fosamprenavir boosted with ritonavir
16222092|NCT01222585|Drug|Metronidazole|Metronidazole will be administered intravenously to premature infants as a 15 mg/kg loading dose followed by maintenance doses of 7.5 mg/kg every 12 hours for infants with >=14 postnatal days and every 24 hours for infants <14 postnatal days.
16222093|NCT01222572|Radiation|Stereotactic boost|
16222094|NCT01222572|Radiation|Conventional RT|
16222095|NCT01222572|Drug|Etoposide|
16222096|NCT01222572|Drug|Cisplatin|
16222097|NCT01222559|Drug|co.don chondrosphere®|co.don chondrosphere® are spheroids in suspension, developed from autologous chondrocytes. The dose depends on the size of the defect, recommended dose is 10-70 spheroids/cm2 defect.
16222098|NCT01222559|Procedure|Microfracture|A procedure in which the subchondral bone is perforated to allow a bloodcloth to form new tissue.
16222099|NCT01222546|Drug|CH5132799|
16222100|NCT01222533|Drug|Tiotropium medium|Tiotropium inhalation solution medium dose
16222101|NCT01222533|Drug|Tiotropium low|Tiotropium inhalation solution low dose
16222102|NCT01222533|Drug|Tiotropium high|Tiotropium inhalation solution high dose
16222103|NCT01222533|Drug|Tiotropium 18mcg|Tiotropium inhalation powder 18mcg
16222104|NCT01222533|Drug|Tiotropium placebo|Placebo inhalation solution
16222105|NCT01222520|Drug|Telmisartan and amlodipine|Telmisartan 80 mg and amlodipine 5 mg once a daily
16222106|NCT01222520|Drug|Telmisartan|80 mg once a daily
16222107|NCT01222494|Behavioral|Behavioral Weight Loss|This intervention is a family-based, behavioral weight loss program that has been employed in studies with overweight and obese children, as well as with children who have diabetes. For the proposed study, the program has been modified to fit the needs of disruptive and behaviorally disturbed youth and their families. The modified program includes 16 weeks of weekly visits with a study interventionist, and supplemental phone contacts as needed. Phone contacts will only replace in-person visits if absolutely necessary to achieve the visit.
16222108|NCT01222494|Behavioral|Diet and Exercise Education|Participants assigned to this arm will receive monthly medically validated, individualized diet and exercise education by a trained research professional.
16222109|NCT01222468|Drug|nabilone 0.5 mg|nabilone 0.5 mg tablets od titrated to a maximum daily dose of 3mg po over an 11-week phase
16222110|NCT01222468|Drug|placebo|placebo 0.5 mg po daily, dose titrated to a maximum daily dose of 3.0mg po over an 11-week phase
16222111|NCT01222455|Drug|Fostamatinib|Oral tablets, single dose
16222112|NCT01222442|Drug|AZD3199|Single dose, oral inhalation
16222113|NCT01222442|Drug|Moxifloxacin|Single dose, oral encapsulated tablet
16222114|NCT01222442|Other|Placebo comparator|Single dose, oral inhalation
16222115|NCT01222429|Other|vegan diet|Intervention group participants will follow a low-fat vegan diet and will receive instruction on this diet through the course of the study
16222116|NCT01222429|Other|diet following ADA guidelines|participants will be given instruction on the ADA guidelines for diabetes, and will follow an individualized plan based on these guidelines
16222117|NCT01222416|Radiation|Radiopharmaceutical Administration [18F]-FDG|Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi,route IV. Time interval between administration and scanning: 60 +/- 10minutes post-injection.
16222118|NCT01222416|Radiation|Radiopharmaceutical: [18F]-FLT|Adult dose: (0.15 mCi/kg ranging from 3 to 16 mCi), route = IV, Time interval between administration and scanning: 60 +/- 10minutes post-injection.
16222119|NCT01222403|Biological|Fluad_MF59-adjuvanted trivalent influenza subunit vaccine|
16222120|NCT01222403|Biological|Vantaflu_MF59-adjuvanted trivalent influenza subunit vaccine|
16222121|NCT01222390|Device|Contour Profile Tissue Expander|The Contour Profile Tissue Expander is a tissue expander with a greater height to width ratio than traditional tissue expanders. This increased ratio allows for greater lower pole expansion, thus creating a more natural looking, ptotic breast. Additionally, the suture tabs on the back of the expander hold the expander in place and prevent malposition and displacement.
16222122|NCT01222377|Procedure|endoscopic surgery|Undergo endoscopic breast surgery
16222123|NCT01222377|Procedure|quality-of-life assessment|Ancillary studies
16222124|NCT01222364|Procedure|Standard Cord Clamping|Immediate clamping (<5 seconds) of the umbilical cord after delivery.
16222125|NCT01222364|Procedure|Delayed Cord Clamping|Clamping of the umbilical cord at 30-45 seconds after birth.
16222126|NCT01222351|Drug|BAY 94-9172 (Florbetaben)|Measure of brain amyloid load using BAY 94-9172 PET/CT
16222127|NCT01222338|Biological|V-5 immunitor|once per day dosing for 2 months
16222128|NCT01222325|Procedure|extracorporeal shockwave lithotripsy (SWL)|patients were submitted to one session SWL at a Dornier Compact Delta lithotripter under general anesthesia under supervision of an anesthesiologist and an urologist.
16222129|NCT01222312|Drug|Cisplatin|75 mg/m2, d1 every 3 weeks
16222130|NCT01222312|Drug|Oxaliplatin|85 mg/m², d1 every 2 weeks
16222131|NCT01222312|Drug|Docetaxel|75 mg/m2, d1 every 3 weeks
16222132|NCT01222312|Drug|Docetaxel|50mg/m2, d1 every 2 weeks
16222133|NCT01222299|Drug|bepotastine besilate nasal product - low dose|sterile nasal product
16222134|NCT01222299|Drug|bepotastine besilate nasal product - medium dose|sterile nasal product
16222135|NCT01222299|Drug|bepotastine besilate nasal product - high dose|sterile nasal product
16222136|NCT01222299|Drug|placebo comparator nasal product|sterile nasal product
16222137|NCT01222286|Drug|IPH2101|0.2 mg/Kg or 2mg/Kg, every 4 weeks by intravenous route over 1 hour, for 6 or up to 12 cycles
16222138|NCT01222273|Dietary Supplement|cholecalciferol (Vitamin D3)|4,000 IU of cholecalciferol (Vitamin D3) orally every day for six months
16222139|NCT01222260|Drug|Bendamustine|"Patients will start bendamustine at dose level 0 and according to CrCl on day 1 and 2 of each cycle:
~CrCl ≥ 60 mL/min: 100 mg/m2 IV on day 1 and 2 of each cycle
~CrCl 59 - 30 mL/min: 90 mg/m2 IV on day 1 and 2 of each cycle
~Available to qualifying subjects is the option to dose escalate to dose level (+)1:
~120 mg/m2 (if CrCl ≥ 60 mL/min at the time of inclusion into the study)
~100 mg/m2 (if CrCl 59-30 mL/min at the time of inclusion into the study)"
16222140|NCT01222260|Drug|Dexamethasone|40 mg orally on days 1, 8, 15, 22 of each cycle
16222141|NCT01222247|Drug|Betamethasone|The active study drug, betamethasone. 3 mg per ml betamethasone sodium phosphate 3 mg per milliliter betamethasone acetate The first dose of study drug medication will be administered at randomization as 2 ml injection; the next dose of 2 ml will be administered 24 hours later.
16222142|NCT01222247|Drug|Placebo|Similar course of identical appearing placebo: 2 mL IM injections, 24 hours apart.
16222143|NCT01222234|Drug|Cholecalciferol - CKD|Cholecalciferol tablet 50,000 IU twice weekly for 8 weeks
16222144|NCT01222234|Device|Calcitriol - CKD|Calcitriol 0.25 mcg once daily for 8 weeks
16222145|NCT01222234|Drug|Cholecalciferol - non-CKD|Cholecalciferol tablet 50,000 IU twice weekly for 8 weeks
16222146|NCT01222221|Biological|glioblastoma multiforme multipeptide vaccine IMA950|
16222147|NCT01222221|Biological|sargramostim|
16222148|NCT01222221|Drug|temozolomide|
16222149|NCT01222221|Other|laboratory biomarker analysis|
16222150|NCT01222221|Other|pharmacological study|
16222151|NCT01222221|Procedure|adjuvant therapy|
16222152|NCT01222221|Radiation|radiation therapy|
16222182|NCT01221948|Device|Deep Brain Stimulation|Rechargeable Deep Brain Stimulation System
16222183|NCT01221935|Other|Pristiq first-line treatment charts|300 charts including patients initiated on Pristiq within the past 6 months as a first-line treatment
16222264|NCT01221272|Drug|Placebo to match ranolazine|Placebo to match ranolazine administered in the same form and frequency as the active drug.
16222536|NCT01219192|Drug|M2ES|M2ES IV D1,8,15,21, every 28days a cyce.
16222153|NCT01222208|Dietary Supplement|Oral Nutrition with dextrose and pressurized whey protein|Ten (10) subjects will be randomly assigned to receive an oral nutrition regimen comprised of 50% of their REE as dextrose and 20% of their REE as pressurized whey protein. Subjects will undergo a six-hour stable isotope infusion protocol one day before surgery (to obtain baseline data) and on the first post-operative day. During both infusion protocols, subjects will be asked to carry out their assigned oral nutrition regimen. To minimize fasting during the perioperative period all subjects will receive peripheral parenteral nutrition (PPN) at the time of surgical incision until the first postoperative day.
16222154|NCT01222208|Dietary Supplement|Peripheral Parenteral Nutrition|Ten (10) subjects will be randomly assigned to receive peripheral parenteral nutrition (PPN) regimen comprised of 50% of their REE as dextrose and 20% of their REE as amino acids. Subjects will undergo a six-hour stable isotope infusion protocol one day before surgery (to obtain baseline data) and on the first post-operative day. During both infusion protocols, subjects will be asked to carry out their assigned PPN regimen. To minimize fasting during the perioperative period all subjects will receive PPN at the time of surgical incision until the first postoperative day.
16222155|NCT01222195|Drug|Lenalidomide|10 mg/day by mouth on days 1-21 of every 28 day cycle.
16222156|NCT01222195|Drug|Darbepoetin alfa|200 mcg subcutaneously every 2 weeks of a 28 cycle.
16222157|NCT01222182|Drug|atorvastatin|All patients desired to change atorvastatin 10, 20mg to an equivalent that is covered by their prescription plan. This is accomplished by either pharmacists by MD/Pharmacist practice agreement or physicians in usual practice
16222158|NCT01222169|Drug|NaCl 0,9%|Propofol 3micrgr/ml (TCI plasma concentration) and NaCl 0,9% 2min. and 10min. application
16222159|NCT01222156|Procedure|Remote magnetic navigation|Remote magnetic navigation of electrophysiology catheters to target intracardiac anatomical sites at mapping-ablation procedures in patients with cardiac arrhythmias
16222160|NCT01222156|Device|Magnetecs Catheter Guidance Control and Imaging system|Magnetecs Catheter Guidance Control and Imaging (CGCI) system
16222161|NCT01222143|Drug|NOVE-HiDAC|"NOVE-HiDAC consists of mitoxantrone, etoposide, and modified high-dose cytarabine. During induction patients will receive mitoxantrone by IV on Days 6-10, etoposide by IV on Days 6-10 and cytarabine by IV on Days 11-12.
~During consolidation patients will be receiving mitoxantrone by IV on Days 1-10 and cytarabine by IV on Days 6, 8 and 10."
16222162|NCT01222143|Drug|Nilotinib|"The dose of nilotinib will be determined according to a dose escalation design. There will be three dose levels used in the study.
~During induction, nilotinib will be given orally on Days 1-12.
~During consolidation, nilotinib will be given orally on Days 1-10."
16222163|NCT01222117|Biological|Plasmin|Plasmin prepared in 0.9% saline for injection
16222164|NCT01222117|Biological|Plasminogen Activator|Plasminogen activator used according to the Investigator's clinical judgment.
16222165|NCT01222117|Other|Placebo|Normal saline for injection at the same volume as the plasminogen activator.
16222166|NCT01222091|Drug|Propranolol|Propranolol administered intravenously, initially set to target plasma concentration of 5 ng/mL, titrated upward in 5 ng/mL intervals until a final concentration of 15 ng/mL is achieved.
16222167|NCT01222091|Drug|Placebo to Match Propranolol|
16222168|NCT01222091|Drug|Remifentanil|Remifentanil administered intravenously at a plasma concentration of 3 ng/mL.
16222169|NCT01222078|Biological|otelixizumab|Two treatment courses of otelixizumab given 6 months apart. Each treatment course will consist of 8 consecutive days of otelixizumab intravenous infusions (each given over 30 minutes).
16222170|NCT01222052|Drug|5-Fluorouracil, Epirubicin, Cyclophosphamide, Docetaxel|"Arm A 5-FU 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2 q3weeks followed by Docetaxel 100 mg/m² q3weeks
~Arm B 5-FU 500mg/m2, Epirubicin 100mg/m2, Cyclophosphamide 500mg/m2 q6weeks"
16222171|NCT01222039|Other|Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue.|"Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue. Low dose: 1 x10e6 / Kg.
~Conventional treatment:Gradually descending dosage of prednisone and cyclosporin or tacrolimus for at least 46 weeks. Starting dose: 1 mg/Kg/24 h prednisone and 3 mg/Kg/12 h cyclosporin."
16222172|NCT01222039|Other|Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue.|"Conventional treatment plus intravenous infusion of allogenic mesenchymal stem cells from adipose tissue. High dose: 3 x10e6/Kg.
~Conventional treatment:Gradually descending dosage of prednisone and cyclosporin or tacrolimus for at least 46 weeks. Starting dose: 1 mg/Kg/24 h prednisone and 3 mg/Kg/12 h cyclosporin."
16222173|NCT01222026|Drug|Strontium Ranelate + Ca/Vitamin-D|2g Strontium Ranelate once daily 1000mg Calcium 800 IE Vitamin D
16222174|NCT01222026|Drug|Placebo|Placebo 1000mg Calcium 800 IE Vitamin-D
16222175|NCT01222013|Drug|Imatinib Mesylate|patient will receive Imatinib (Glivec®), 300 mg/m²/day, per oral, in conjunction with chemotherapy, maximum dose allowed 400 mg/dia.
16222176|NCT01222000|Drug|apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side|After inclusion, the localization of test area will be decided and the side to treat with VEREGEN 10% will be randomized. Patient will be seen every week for 4 weeks for clinical evaluation of assessment criteria by an independent assessor. According to the randomisation he will apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side. If there is an improvement of at least a test zone he will enter in the follow-up period for 8 weeks.
16222177|NCT01222000|Drug|apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side|After inclusion, the localization of test area will be decided and the side to treat with VEREGEN 10% will be randomized. Patient will be seen every week for 4 weeks for clinical evaluation of assessment criteria by an independent assessor. According to the randomisation he will apply VEREGEN ® 10 % on a randomized area and the moisturizing cream of the other side. If there is an improvement of at least a test zone he will enter in the follow-up period for 8 weeks.
16222178|NCT01221987|Procedure|Cervical sampling|Cervical biopsy or excision specimen testing for human papillomavirus deoxyribose nucleic acid types
16222179|NCT01221987|Other|Data collection|Questionnaire completion
16222180|NCT01221974|Device|Essure Micro Insert|
16222181|NCT01221961|Device|Masimo Radical-7|The Masimo device will be placed on one finger of the patient. To see whether or not the hemoglobin values recorded at the same time matches between the standard clinical practice (CSMC Lab and outside Lab) and the Masimo device
16222184|NCT01221935|Other|Pristiq second-line treatment charts|800 charts including patients initiated on Pristiq within the past 6 months as a second-line treatment (following first-line treatment with a Serotonin Norepinephrine Reuptake Inhibitor (SNRI) or Selective Serotonin Reuptake Inhibitors (SSRIs)).
16222185|NCT01221935|Other|SNRI or SSRI first-line treatment charts|800 charts including patients initiated on a Serotonin Norepinephrine Reuptake Inhibitor (SNRI) or Selective Serotonin Reuptake Inhibitors (SSRIs) (excluding Pristiq) within the past 6 months as a first-line treatment.
16222186|NCT01221935|Other|SNRI or SSRI second-line treatment charts|800 charts including patients initiated on a Serotonin Norepinephrine Reuptake Inhibitor (SNRI) or Selective Serotonin Reuptake Inhibitors (SSRIs)(excluding Pristiq) within the past 6 months as a second-line treatment (following the first-line treatment with a SNRI or SSRI).
16222187|NCT01221922|Device|RevLite Q-Switched Nd:YAG Laser|Laser treatment once every 2 weeks for a total of 10 treatments.
16222188|NCT01221909|Drug|Tranexamic acid|Single dose TA 500mg or placebo will be given in DCR surgery right after the first surgical incision.
16222189|NCT01221909|Drug|saline solution|5cc saline solution
16222190|NCT01221896|Procedure|C11-Choline PET/CT|
16222191|NCT01221883|Drug|Diazepam|Single dose 10mg Diazepam tablet
16222192|NCT01221870|Drug|Tesetaxel once every 3 weeks|Tesetaxel capsules orally once every 21 days; duration of therapy not to exceed 12 months
16222193|NCT01221870|Drug|Tesetaxel once weekly|Tesetaxel capsules orally once every 7 days for 3 consecutive weeks in a 28-day cycle; duration of therapy not to exceed 12 months
16222194|NCT01221857|Drug|NiCord®|NiCord® is a cell-based product composed of umbilical cord-derived ex vivo expanded stem and progenitor cells.
16222195|NCT01221844|Dietary Supplement|Lattoglobina (Grunenthal) containing bLf|One capsule of Lattoglobina contains 100 mg of bLf. Dosage: one capsule twice a day before meals. In twin pregnancy or in severe anemia the dosage is increased to 2 capsules twice a day before meals
16222196|NCT01221844|Drug|FerroGrad by Abbott|Dosage: one tablet/day containing 540 mg of ferrous sulfate during meals
16222197|NCT01221831|Drug|estetrol, P 1 and placebo tablets|"6 treatment cycles each consisting of 28 days of oral administration as follows:
~Days 1-24: one estetrol tablet and one P1 tablet per day
~Days 25-28: two placebo tablets per day"
16222198|NCT01221831|Drug|estetrol, P2 and placebo tablets|"6 treatment cycles each consisting of 28 days of oral administration as follows:
~Days 1-24: one estetrol tablet and one P2 tablet per day
~Days 25-28: two placebo tablets per day"
16222199|NCT01221831|Drug|Estradiol valerate, dienogest and placebo tablets|"6 treatment cycles each consisting of 28 days of oral administration as follows:
~Days 1-26: one tablet of Estradiol valerate/dienogest per day
~Days 26-28: one placebo tablet per day"
16222200|NCT01221818|Drug|E6007|E6007 25mg single dose or matching placebo
16222201|NCT01221818|Drug|E6007|E6007 50mg single dose or matching placebo
16222202|NCT01221818|Drug|E6007|E6007 100mg single dose or matching placebo
16222203|NCT01221818|Drug|E6007|E6007 200mg single dose or matching placebo
16222204|NCT01221818|Drug|E6007|E6007 400mg single dose or matching placebo
16222205|NCT01221818|Drug|E6007|E6007 600 mg single dose or matching placebo
16222206|NCT01221792|Drug|Carvedilol|"Oral, twice daily dosing using 3.125 mg tablets.
~1 week titration (6.25 mg/day)prior to a 3 week flexible dosing option ranging from 6.25 mg/day to 15.625 mg/day followed by a 1 week taper (6.25 mg/day)."
16222207|NCT01221792|Drug|Placebo|Non active comparator
16222208|NCT01221779|Behavioral|Intensive language therapy|2 weeks of daily computerized naming training, daily, 3 hours
16222209|NCT01221779|Behavioral|Intensive language therapy|2 weeks of daily computerized naming training, daily, 3 hours
16222210|NCT01221753|Drug|docetaxel|
16222211|NCT01221753|Drug|cisplatin|Given intravenously on day 1 of each cycle
16222212|NCT01221753|Drug|5-FU|
16222213|NCT01221753|Radiation|IMRT|
16222214|NCT01221753|Drug|cetuximab|
16222215|NCT01221753|Drug|carboplatin|
16222216|NCT01221740|Drug|Savella|"The patients will be titrated to the maintenance dose of 50 mg BID over a 7-day period, and will be on the medication for 10 weeks.
~12.5 mg QD on day 1 12.5 mg BID on days 2 and 3 25 mg BID on days 4, 5, 6, and 7 50 mg BID beginning day 8"
16222217|NCT01221727|Drug|Denosumab|Eighteen (18) subjects will receive 1 fixed dose administration of denosumab.
16222218|NCT01221727|Drug|Midazolam|All subjects will receive two oral dose administrations of midazolam.
16222219|NCT01221701|Behavioral|In-Home Cognitive Behavioral Psychology|Adapted form of CBT that is delivered in the home setting, uniquely designed for young, low income new mothers, and is explicitly integrated with home visitation. IH-CBT is delivered by a masters level therapist. It consists of 15 weekly sessions and 1 booster session provided 1 month after the 15th session.
16222220|NCT01221688|Procedure|Axillar Sentinel lymph node biopsy|Group 2 : Patients without proven axillary involved nodes will undergo SLNB and a complete axillary level I-II lymphadenectomy only in the case of detection failure or involved SLN and a SLNB alone in the others cases. Patients of this last group will be followed 5 years in order to evaluate the risk of axillary relapse without lymphadenectomy.
16222221|NCT01221688|Procedure|SLNB and complete level I-II axillary lymphadenectomy|group 1 : patients with proven involved axillary nodes will undergo SLNB and complete level I-II axillary lymphadenectomy.
16222222|NCT01221675|Drug|Antibody TF2|preciblage with an antibody
16222223|NCT01221675|Radiation|IMP-288-Lutetium|Internal Radiation
16222224|NCT01221675|Radiation|IMP-288-Indium|Imaging
16222225|NCT01221662|Drug|Siwu Tang|Siwu Tang 3 g bid(oral) continuously two weeks
16222226|NCT01221649|Device|ICD/CRT-D|BIOTRONIK ICD family Lumax 540 and its successors
16222227|NCT01221636|Drug|Abatacept|Solution for injection, Intravenous, 750 mg, 1 day
16222228|NCT01221623|Biological|AA4500|2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
16222263|NCT01221272|Drug|Ranolazine|"One 500 mg tablet in the evening on Day 1 of the period
~One 500 mg tablet, twice daily on Days 2-3 of the period
~Two 500 mg tablets (1000 mg total), twice daily from Day 4 to the end of the period (Day 15 ± 2 days)"
16222229|NCT01221623|Biological|Placebo|2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
16222230|NCT01221610|Device|Passeo-18 Lux DRB|
16222231|NCT01221610|Device|Standard PTA (POBA)|
16222232|NCT01221597|Biological|AA4500|2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
16222233|NCT01221597|Biological|Placebo|2 injections separated by at least 24 hours but not more than 72 hours. At least 24 hours but not more than 72 hours after the 2nd injection of the treatment cycle, the investigator will model the plaque (ie, gradual, gentle stretching of the flaccid penis in the direction opposite to the curvature). Treatment may be repeated after 42 days (± 5 days) for up to 4 treatment cycles.
16222234|NCT01221571|Drug|AFM 13|Cohort escalation then expansion phase design. Starting dose 0.01 mg/kg. 4 weekly drug administrations.
16222235|NCT01221558|Dietary Supplement|lycopene|
16222236|NCT01221545|Drug|AZD1656|3 escalating dose levels are planned. Administration of the escalating doses of AZD1656 will be based on review of available safety from the previous dose.
16222237|NCT01221545|Drug|Placebo|Placebo
16222238|NCT01221532|Behavioral|SHHE Peridischarge Intervention|"Support from Hospital to Home (SHHE) Peridischarge Intervention patients will receive Usual care plus
~a visit with in-hospital registered nurse, who provides additional patient education, assesses patient's needs post-hospitalization, communicates with the medical team, and develops a personalized discharge plan;
~two phone calls from a nurse practitioner(NP)/physician assistant (PA) after discharge, in which adherence to medications, treatment plan, and access to outpatient care, and other issues identified during the hospitalization will be explored;
~the provision of a phone support line, on which an NP/PA will call patients back within 24 hours to answer questions and assist transition to outpatient care."
16222239|NCT01221519|Drug|AZD1656|3 different formulations, A, B and C of AZD1656 assessed before food intake and formulation B also after food intake
16222240|NCT01221506|Drug|Pazopanib|800 mg PO QD x 28 days
16222241|NCT01221506|Device|DCE-MRI and Quantitative Doppler Ultrasound|Contrast-enhanced MRI
16222242|NCT01221493|Procedure|Cryo biopsy|Cryoprobe, Erbe Company
16222243|NCT01221467|Device|Overnight closed-loop|The closed-loop system is purpose-built and comprises a hand-held computer containing the algorithm and communicating with the CGM device and the insulin pump.
16222244|NCT01221454|Procedure|Allogenic bone marrow stem cells transplantation|30ml allogenic bone marrow stem cells were infused to patients using interventional method via portal vein or hepatic artery as well as conserved therapy
16222245|NCT01221454|Drug|Conserved therapy|Oral or intravenous administration
16222246|NCT01221441|Biological|TissueGene-C|Single intraarticular injection at 3 x 10e7 cells
16222247|NCT01221441|Drug|Normal Saline|Single intraarticular injection of normal saline as a placebo control
16222248|NCT01221428|Biological|Umbilical Cord Mesenchymal Stem Cells|Intravenous infusion of ex vivo cultured umbilical cord mesenchymal stem cells(2*10/7),one week later,conduct intervention operation to inject mesenchymal stem cells to mesenteric artery(1*10/7).
16222249|NCT01221402|Drug|extended-release niacin (Niaspan)|Patients will be randomized in a 1:1 ratio to receive extended-release niacin (1500 - 2000 mg per day) or matching placebo that contains 50 mg of crystalline niacin (enough to cause flushing but has no effect on lipid levels).
16222250|NCT01221389|Drug|Human Plasma|Patients will receive either 2 units of AB+ plasma or 2 units of hydroxyethylated starch control solution once they are sent to the OR for emergency surgery to address etiology for hemorrhagic shock.
16222251|NCT01221376|Drug|Imatinib Mesylate|Patient will receive Imatinib Mesylate, continuous-use, 260 mg/m2/day dose, maximum allowed 400 mg, for 24 months.
16222252|NCT01221363|Behavioral|Life style intervention|Reduction of sedentary behavior through theory-based individually tailored lifestyle intervention.
16222253|NCT01221350|Dietary Supplement|Lipoic acid|Lipoic acid 600 mg dose (two 300 mg capsules) once daily in the morning. All patients continued their asthma treatments given by their primary care physician also they were allowed to use rescue medication on demand consisting in inhaled salbutamol. During basal and 8 weeks visits spirometry with bronchodilator challenge, sputum induction and quality of life questionnaires and asthma control test were performed.
16222254|NCT01221350|Dietary Supplement|Placebo|Placebo (two capsules filled with 300 mg vehicle) once daily in the morning during 60 days. All patients continued their asthma treatments given by their primary care physician also they were allowed to use rescue medication on demand consisting in inhaled salbutamol. During basal and 8 weeks visits spirometry with bronchodilator challenge, sputum induction and quality of life questionnaires and asthma control test were performed
16222255|NCT01221337|Other|heparin free haemodialysis|"Comparison of two haemodialyzers VIE 2,1 versus EVODIAL 2,2 in a strategy of heparin-free haemodialysis (HFH)."
16222256|NCT01221311|Device|Fully covered Metallic Stent|Covered Wallflex Biliary (TM)
16222257|NCT01221311|Device|Plastic Stent|Patients randomized to the PS group will be treated using a standard algorithm. Specifically, the stricture will be dilated using a passage dilator and/or dilation balloon catheter, and one or two PS will be deployed depending on the baseline characteristics of the stricture as well as the diameter of the proximal and distal bile duct (standard of care). The endoscopist will sequentially dilate and upsize the cumulative stent diameter on ensuing ERCPs, until the stricture has been obliterated using clinical and fluoroscopic criteria.
16222258|NCT01221298|Drug|ABT-450|tablets
16222259|NCT01221298|Drug|ABT-072|tablets
16222260|NCT01221298|Drug|Ribavirin|tablets
16222261|NCT01221298|Drug|Ritonavir|capsules
16222262|NCT01221285|Biological|German cockroach (Blattella germanica) allergenic extract|Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 mL of extract at a concentration of 1:20 wt/vol.
16222537|NCT01219192|Drug|M2ES|M2ES 45mg IV D1,8,15,22 28days a cycle
16222265|NCT01221272|Procedure|SPECT MPI|Gated single photon emission computed tomography (SPECT) myocardial perfusion imaging (MPI) to confirm the presence of reversible exercise-induced left ventricular perfusion defect size (PDS) performed within 12 weeks prior to baseline or at the baseline visit, and at the end-of-period 1 and end-of-period 2 visits.
16222266|NCT01221272|Behavioral|Exercise|Treadmill stress test
16222267|NCT01221259|Drug|E2212|single ascending doses ranging from 10mg to 250mg
16222268|NCT01221259|Drug|placebo|a single dose of matching placebo
16222269|NCT01221246|Drug|GM602|First 9 moderate patients (either co-treated or not co-treated) will be randomized to receive 320 mg/dose of GM602 or placebo in a 2:1 ratio, then the next 9 moderate patients (either co-treated or not co-treated) will be randomized to receive 480 mg/dose of GM602 or placebo in a 2:1 ratio. Concurrently, 18 severe patients will be randomized in the same manner. Total 12 moderate and 12 severe patients will receive GM602.
16222270|NCT01221246|Drug|Placebo Comparator|First 9 moderate patients (either co-treated or not co-treated) will be randomized to receive 320 mg/dose of GM602 or Matching Placebo (Bacteriostatic Saline) for GM602 in a 2:1 ratio, then the next 9 moderate patients (either co-treated or not co-treated) will be randomized to receive 480 mg/dose of GM602 or placebo in a 2:1 ratio. Concurrently, 18 severe patients will be randomized in the same manner. Total 6 moderate and 6 severe patients will receive placebo.
16222271|NCT01221233|Other|Neuromuscular Electrical Stimulation|"Neuromuscular Electrical Stimulation (NMES) to the low back muscles (i.e. spinal extensors) will be applied at the parameters previously used in the knee muscles at the maximal tolerable intensity, which results in a full, sustained isometric contraction of the back muscles. Pad placement will be just below the waist line, with 2, 2X2 inch pads, on either side of the spine. Participants will be positioned on their belly with 2 pillows under their stomach to level the spine and secured to a table using a belt that crosses the buttock.
~The lumbar stabilization program will include exercises targeting the back muscles in three positions: standing, prone (belly), and quadruped (hands and knees)."
16222272|NCT01221233|Other|Moist Heat|"For participants who do not receive NMES, moist heat will be applied for 15 minutes in a position of comfort for the participant.
~The lumbar stabilization program will include exercises targeting the back muscles in three positions: standing, prone (belly), and quadruped (hands and knees)."
16222273|NCT01221220|Behavioral|Standard Packard Pediatric Weight Control Program|Six-month, family-based, group, behavioral weight control program
16222274|NCT01221220|Behavioral|Standard Packard Pediatric Weight Control Program plus Home-based advising on environmental changes|Six-month, family-based, group, behavioral weight control program plus Home-based Environmental strategies intervention
16222275|NCT01221207|Device|Total Contact Cast|A total contact cast (TCC) is a special cast technique that is used to take the pressure and shear stress off the ulcer to assist in the healing.
16222276|NCT01221207|Device|Instant Total Contact Cast (ITCC)|The instant total contact cast (ITCC) is a technique that uses the removable cast walker, but secures it so it cannot be removed between clinic visits and evaluation by the subject or the physician.
16222277|NCT01221207|Device|Removable Cast Walker (RCW)|The removable cast walker (RCW) is a commercial product that is similar to a cast. It is secured with Velcro straps around the foot and leg and it is also effective at removing the pressure and shear stress on the foot.
16222278|NCT01221194|Behavioral|Standard therapy|Standard therapy consisting of education, regular foot care and protective shoes and insoles. The standard therapy group will use the stockings they normally wear.
16222279|NCT01221194|Device|PFC Stockings|A pressure and friction reducing stocking. The novelty of the PFC Sock stems from its innovative double layer structure and technological fibre composition. These simultaneously and significantly reduce both pressure and friction in a format that is practical for everyday wear with therapeutic shoes in high-risk cases.
16222280|NCT01221181|Drug|Eculizumab|Dosage/Frequency: 900 mg IV once a week for 4 weeks, 1200 mg IV week 5, then 1200 mg IV every 2 weeks through week 53.
16222281|NCT01221142|Device|"Cincinnati Sub-Zero, Blanketrol III"|
16222282|NCT01221129|Other|Acclimation|11 mg Zn/day as a controlled intake level
16222283|NCT01221129|Other|Dietary zinc depletion|< 1 mg Zn/day achieved by providing a liquified diet of defined nutrient content
16222284|NCT01221129|Other|Dietary zinc repletion|15 mg Zn/day as a daily supplement plus normal habitual diet without restriction
16222285|NCT01221116|Drug|levosimendan|levosimendan 0.1 microgram/kg/min) for 24 hours
16222286|NCT01221103|Drug|Combination of dexamethasone, ofatumumab and bendamustine|"Ofatumumab (liquid concentrate for infusion in glass vials) infused iv on day 1 at 300 mg during the first cycle, followed by infusions of 1000 mg on day 1 of each subsequent cycle
~Bendamustine (powder dissolved in sterile water) infused iv over 30-60 minutes at the dose of 120 mg/m2 (days 2,3 every 21 days) or 120 mg/m2(days 2,3 every 28) or 90 mg/m2 (days 2,3 every 28 days) depending on toxicity
~Dexamethasone administered i.v. at 40 mg (days 1,2,3,4)"
16222287|NCT01221090|Behavioral|PDA|Technological assistance
16222288|NCT01221090|Behavioral|CDSMP|6-week classes
16222289|NCT01221090|Behavioral|PDA/CDSMP|Combined technology and education
16222290|NCT01221077|Drug|OSI-906|As of 01 March 2013, OSI-906 is no longer being administered
16222291|NCT01221077|Drug|Erlotinib|Erlotinib administered orally
16222292|NCT01221077|Drug|Placebo|As of 01 March 2013, the matching placebo is no longer being administered
16222293|NCT01221064|Procedure|Early drainage removal|Drainage will be removed in postoperative day 1
16222294|NCT01221064|Procedure|Late drainage removal|Drains will be kept until daily drainage is 30ml and then removed
16222295|NCT01221051|Procedure|active management of the third stage of labor|early cord clamping, administration of oxytocin 10 IU, controlled cord traction, uterine massage after placenta expulsion
16222296|NCT01221051|Procedure|expectant management of the third stage of labor|early cord clamping, administer saline solution 2 mL i.v,wait for signs of placenta detachment, encourage the woman to push ot placenta by her own effort, uterine massage after placenta expulsion
16222297|NCT01221025|Drug|Parecoxib|The study group will receive first dose of intravenous (IV) injection of parecoxib sodium 40 mg (in a volume of 2 ml) 60 min before the anticipated end of surgery, followed 2 ml IV injection of parecoxib 40 mg will be occurred at 12, 24 and 36 h after the first dose of parecoxib.
16222376|NCT01220388|Dietary Supplement|L-lysine|L-lysine, 4,95 G at day : 0,55 G 3 times a day, orally, during meals
16222298|NCT01220999|Drug|CS-1008|CS-1008 was administered once weekly as an intravenous infusion over 30 ± 10 minutes at a dose range of 0.2 to 6 mg/kg. On Days 1 and 36, CS-1008 infusions were radiolabeled with 111^In (5-7 mCi).
16222299|NCT01220986|Procedure|Liver biopsy|0, 30, 60, 90 min post inflow-division
16222300|NCT01220973|Drug|atorvastatin calcium|
16222301|NCT01220973|Drug|celecoxib|
16222302|NCT01220973|Other|laboratory biomarker analysis|
16222303|NCT01220960|Other|art therapy|Art therapy sessions, 2 hours in duration, 1 session/week, 8 continuous weeks of sessions. Each group will be limited to eight women as space is limited.
16222304|NCT01220947|Drug|Copegus|Copegus 1000 mg or 1200 mg po daily for 24 weeks.
16222305|NCT01220947|Drug|Danoprevir|Danoprevir 50 mg BID
16222306|NCT01220947|Drug|Danoprevir|Danoprevir 100 mg BID
16222307|NCT01220947|Drug|Danoprevir|Danoprevir 200 mg BID
16222308|NCT01220947|Drug|Pegasys|Pegasys 180 microgram sc qw
16222309|NCT01220947|Drug|Ritonavir|Ritonavir 100 mg
16222310|NCT01220921|Procedure|Lumbar Discectomy|Microsurgical removal of disc that is compressing a nerve root
16222311|NCT01220921|Procedure|Single-level lumbar fusion|pedicle screws with arthrodesis as directed by surgeon. Fusion can be posterolateral, interbody, or both.
16222312|NCT01220908|Device|Lung Volume Reduction Coil (LVRC)|Implantation of Lung Volume Reduction Coil(s) (LVRC)
16222313|NCT01220908|Device|Coils|Lung Volume Reduction Coil(s)
16222314|NCT01220895|Biological|CMV-specific T-cells, single infusion following single positive CMV PCR result|"Intravenous ganciclovir 5mg/kg twice daily
~Oral valganciclovir 900mg twice daily
~Intravenous foscarnet 90 mg/kg twice daily"
16222315|NCT01220882|Radiation|Radiographic skeletal age assessment|bone age assessment from the elbow lateral radiograph
16222316|NCT01220869|Drug|Degarelix|Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).
16222317|NCT01220856|Drug|Reparixin|Reparixin + immunosuppression
16222318|NCT01220843|Drug|Placebo|dosage : 2 tablets 3 times per day corresponding taken during meals during 12 weeks
16222319|NCT01220843|Drug|Sevelamer carbonate|dosage : 2 tablets 3 times per day corresponding taken during meals during 12 weeks ( each tablet :800mg sevelamer carbonate
16222320|NCT01220830|Device|Cytotron|Exposure to RFQMR with Cytotron for 28 consecutive days for one hour daily.
16222321|NCT01220817|Drug|3 POMx capsules|3 POMx capsules daily
16222322|NCT01220817|Drug|1 POMx capsule|1 POMx capsule daily
16222323|NCT01220791|Other|In vitro fertilization treatment for infertility|IVF treatment
16222324|NCT01220778|Behavioral|Exercise|
16222325|NCT01220765|Device|Capnography|In the capnography arm, respiratory monitoring is performed with pulse oximetry and capnography. If the capnogram indicates sub-optimal ventilation and/or apnea, denoted as a flat line on the capnometer for ≥ 15 seconds, a respiratory rate ≤ 6, or a end-tidal CO2 > 50 mmHg, medical staff will intervene by arousing the patient, performing chinlift or jawthrust, abandon from giving additional propofol, or provision of oxygen. The nurse qualified in sedation management will assess capnography him/ herself.
16222326|NCT01220752|Radiation|carbon ion boost|8 fractions carbon ion (8 x 3 GyE C12) therapy followed by 25 fractions of IMRT corresponding to a total dose of approximately 74 GyE. Treatment duration is approximately 61/2-7 weeks
16222327|NCT01220739|Device|Transcranial Laser Therapy|Transcranial laser therapy is administered with the NeuroThera® Laser System (NTS) in subjects diagnosed with acute ischemic stroke. A laser system is a medical instrument that concentrates energy light on an area. Laser treatment has been used to deliver intense light energy to aid in the healing of tissues and wounds. The transcranial laser treatment procedure consists of applying the NTS laser to twenty different sites on the skull for two minutes at each site.
16222328|NCT01220726|Drug|Botox|Botox injection
16222329|NCT01220726|Drug|Placebo|Placebo injection
16222330|NCT01220713|Procedure|Hyperbaric Oxygen Therapy|1.5 atm abs oxygen equivalent of 75% oxygen (balance 25% nitrogen), 40 treatments of 60 minutes each during a time period of up to ten weeks.
16222331|NCT01220713|Procedure|Hyperbaric Oxygen Therapy|2.0 atm abs oxygen equivalent of 100% oxygen (no nitrogen), 40 treatments of 60 minutes each during a time period of up to ten weeks.
16222332|NCT01220713|Procedure|Hyperbaric Oxygen Therapy|sham--air equivalent of 10.5% oxygen (balance 89.5% nitrogen), 40 treatments of 60 minutes each during a time period of up to ten weeks.
16222333|NCT01220700|Other|Triclosane|Triclosane coated suture material
16222334|NCT01220700|Other|Control|Ordinary suture material
16222335|NCT01220687|Drug|iNO|Immediately after birth, subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
16222336|NCT01220687|Other|Nitrogen|Subjects will be randomized to receive iNO (20ppm) or nitrogen (placebo gas) with blended oxygen (starting with 0.3). Fraction of inspired oxygen will be adjusted by 0.1 increments every 15 seconds targeting pre-ductal oxygen saturation of 70-85% in the first 2 minutes of life, and then 85-93% until the end of the study period while requiring supplemental oxygen.
16222337|NCT01220674|Other|cognitive testing|computer-based cognitive assessment
16222338|NCT01220661|Drug|Cefotetan|preoperative one dose prophylactic antibiotic (2g iv, within 1 hour before skin incision)
16222339|NCT01220648|Drug|Nilotinib, interferon-alfa|
16222340|NCT01220635|Behavioral|Positive Thoughts and Actions Program|Students in the skills group will attend a 12-session (50 minutes each), 12-week program with 4-6 other students. The skills group will take place at school during school hours. Parents in the skill group will be asked to participate in two parent group workshops to take place at their child's school or other participating middle school (2-hours each). In addition, the skill group leader will conduct two individual family meetings with the student and parent(50 minutes each).
16222377|NCT01220388|Dietary Supplement|placebo|placebo, 3 times a day, orally, during meals
16222538|NCT01219192|Drug|M2ES 60mg|M2ES 60mg IV D1,8,15,22 every 28days a cycle
16222575|NCT01218958|Drug|Medisorb naltrexone 190 mg|Intramuscular (IM) injection once every 4 weeks for a total of 6 administrations.
16222341|NCT01220635|Behavioral|Individual Support Program|Students will be individually interviewed (60-90 minutes) at school to review areas of stress and support. The health professional conducting the interview will reinforce the student's strengths, and provide connections to sources of help from caring adults at home and at school. Parents will be called following the assessment to help the family locate appropriate resources if needed (e.g., tutoring resources, school counselor).
16222342|NCT01220622|Drug|Nimodipine|Administration of nimodipine 30mg tid for 6 months
16222343|NCT01220622|Drug|Placebo|Administration of placebo 30mg tid for 6 months
16222344|NCT01220609|Drug|Ixabepilone|Given IV
16222345|NCT01220609|Other|Laboratory Biomarker Analysis|Correlative studies
16222346|NCT01220596|Drug|Entecavir and Pegylated interferon α-2a Sequential Treatment Group|Entecavir/Baraclude(TM), 0.5mg, oral administration, once daily, for the first 12 weeks Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, from week 4 to 52 for 48 weeks
16222347|NCT01220596|Drug|Pegylated interferon α-2a Monotreatment Group|Pegylated interferon α-2a/Pegasys(TM), 180mcg, subcutaneous injection. once a week, for the first 48 weeks
16222348|NCT01220583|Drug|cisplatin|Given IV
16222349|NCT01220583|Radiation|3-dimensional conformal radiation therapy|Undergo radiotherapy
16222350|NCT01220583|Radiation|intensity-modulated radiation therapy|Undergo radiotherapy
16222351|NCT01220570|Drug|Ridaforolimus + Dalotuzumab|Ridaforolimus (MK-8669) once daily for 5 consecutive days per week and Dalotuzumab (MK-0646) intravenously (IV) once weekly for 2 weeks
16222352|NCT01220570|Drug|Ridaforolimus|Ridaforolimus 40 mg (once daily for 5 consecutive days per week) for 2 weeks, 10 mg enteric-coated tablets
16222353|NCT01220570|Drug|Dalotuzumab|Dalotuzumab, intravenously (IV) at 10 mg/kg/week for 2 weeks
16222354|NCT01220557|Behavioral|PRIMAS|PRIMAS is a newly developed treatment and education programme for type 1 diabetic patients. It consists of 12 lessons (duration 90 minutes each), slides for diabetes educators and patient material
16222355|NCT01220557|Behavioral|DTTP|The German DTTP (Diabetes Teaching and Treatment Programme) - The German ZI Program - is an established treatment and education programme for intensified insulin treatment consisting of 12 lessons (90 minutes duration each). Flipchart for diabetes educators and patient material.
16222356|NCT01220544|Biological|Haploidentical transplantation with donor NK cells|Pat received a myeloablative conditioning regimen with 12 Gy total-body irradiation in six single doses from day -11 to day -9, thiotepa (5mg/kg/d) on days -8 and -7, fludarabine (40mg/m2/d) from day -6 to day -3, and OKT-3 (5mg/d) from day -5 to day +3. The stem cell graft was aimed to contain > 8 x 10e6 CD34+ cells/kg and < 5 x 10e4 CD3+ cells/kg. A minimum of 1 x 10e7 CD56+CD3- NK cells/kg will be transferred on days +2.
16222357|NCT01220531|Biological|Cultured Thymus Tissue|Potential recipients of cultured thymus tissue are screened for eligibility. The thymus tissue (from an unrelated donor), the donor, and the donor's mother are screened for safety. Cultured thymus tissue is implanted under general anesthesia in the operating room. Cultured thymus tissue is placed into the subject's quadriceps. Two to three months post-implantation, if medically stable, subjects may undergo an allograft biopsy. Subjects undergo laboratory testing for approximately one-year post-implantation. At approximately year 2 post-implantation, subjects are contacted for data collection.
16222358|NCT01220531|Procedure|Blood Draw|
16222359|NCT01220531|Drug|Rabbit anti-thymocyte globulin|Three IV doses of 2 mg/kg RATGAM are given prior to implantation of cultured thymus tissue for immune suppression groups 2, 3, and 4. Each dose is given over 12 hours. RATGAM is usually given on days -5, -4, and -3 prior to implantation of cultured thymus tissue.
16222360|NCT01220531|Drug|Cyclosporine|Csa may be given every 8 or every 12 hours orally or IV before and after implantation of cultured thymus tissue for immune suppression groups 3 and 4. The Csa dose is dependent on T cell numbers and the target CSA trough levels. Csa is weaned as per protocol.
16222361|NCT01220531|Drug|Tacrolimus|If unable to tolerate cyclosporine, then FK506 is given. FK506 may be given every 8 or every 12 hours orally or IV before and after implantation of cultured thymus tissue. FK506 dose is dependent on T cell numbers and the target FK506 trough levels. FK506 is weaned as per protocol.
16222362|NCT01220531|Drug|Methylprednisolone or Prednisolone|Steroids IV or orally may be given before and/or after implantation of cultured thymus tissue. Steroid administration and dosage depends on T cell numbers. Steroids are weaned as per protocol.
16222363|NCT01220531|Drug|Mycophenolate mofetil|Mycophenolate mofetil (MMF) may be given if the T cell count remains elevated 5 days after implantation of cultured thymus tissue. If MMF is given, the dose is 15 mg/kg/dose every 8 hours IV or orally. MMF may be stopped at 35 days or continued for up to six months after implantation of cultured thymus tissue.
16222364|NCT01220518|Drug|Infliximab|Infliximab 5mg/kg is going to be administered for both arm as a 2-hour infusion per dose.
16222365|NCT01220505|Procedure|Surgery|All subjects will have spinal surgery between the levels of T1 and Ilium using the Polaris Deformity Spinal System
16222366|NCT01220492|Drug|conventional plus MSC treatment|received conventional treatment and taken i.v., once per 4 week, at a dose of 0.5*10E6 MSC/kg body for 8 weeks.
16222367|NCT01220492|Drug|conventional plus placebo treatment|received conventional treatment and taken i.v., once per 4 week, at 50 ml saline for 8 weeks.
16222368|NCT01220479|Behavioral|Exercise training program|"Exercise Diabetic and Healthy groups perform a similar training program including two exercise sessions per week, of 90 minutes each, during 9 months (excluding holidays) under supervision by physical education teachers and pediatricians. Sessions comprise various weight-bearing activities: rope skipping, jumping, ball games and gymnastics.
~Control groups are relatively inactive."
16222369|NCT01220466|Device|STAR S4IR LASIK with iDesign Aberrometer|CustomVue LASIK targeted for emmetropia
16222370|NCT01220440|Drug|Methylphenidate|Methylphenidate:10mg x 3 for one week
16222371|NCT01220440|Drug|Placebo|Placebo: 1 pill x 2 for one week, 2 pills x 2 for one week.
16222372|NCT01220440|Drug|Dextroamphetamine|Dextroamphetamine: 5mg x 2 for one week, 10mg x 2 for one week
16222373|NCT01220414|Drug|Naltrexone, then placebo|50 mg of naltrexone
16222374|NCT01220414|Drug|Placebo, then Naltrexone|sugar pill
16222375|NCT01220401|Behavioral|exposure, relaxation, and rescription therapy|veterans reporting chronic nightmares at least once per week for the past month who consent to participate will attend four consecutive weekly sessions lasting approximately two hours each. Participants will log their sleep events and associated symptoms (i.e. PTSD, depression, etc.)
16222378|NCT01220375|Drug|Vinorelbine, G-CSF, & Plerixafor|Patients 1-10 receive 35 mg/m2 vinorelbine i.v. on day 1, G-CSF divided in two daily doses from day 4 until collection of stem cells, and plerixafor as an i.v. application on day 8, at 08:00 AM, in the dose of 240 microg/kg b.w. Stem cell collection is initiated 4 hours later (at 12:00 PM) at day 8, if at least 20 X 103 of CD34+ cells / ml peripheral blood are detected.
16222379|NCT01220375|Drug|Vinorelbine and Plerixafor|Patients 11-20 receive 35 mg/m2 vinorelbine i.v. on day 1 and plerixafor as an i.v. application on day 8, at 08:00 AM, in the dose of 240 microg/kg b.w. No G-CSF will be administered. Stem cell collection is initiated 4 hours later (at 12:00 PM) at day 8, if at least 20 X 103 of CD34+ cells / ml peripheral blood are detected.
16222380|NCT01220375|Drug|G-CSF and Plerixafor|Patients 21-30 receive G-CSF divided in two daily doses from day 4 until collection of stem cells, and plerixafor as an i.v. application on day 8, at 08:00 AM, in the dose of 240 microg/kg b.w. No chemotherapy with vinorelbine will be gine on day 1. Stem cell collection is initiated 4 hours later (at 12:00 PM) at day 8, if at least 20 X 103 of CD34+ cells / ml peripheral blood are detected.
16222381|NCT01220375|Drug|Vinorelbine & Plerixafor on day when CD34 count is at least 15'000 CD34+ cells/ml of peripheral blood|Patients 31-40 receive 35 mg/m2 vinorelbine i.v. on day 1 and plerixafor as an i.v. application at 08:00 AM, on the first day on which the CD34 count has risen to at least 15'000 CD34+ cells/ml of peripheral blood. Stem cell collection is initiated 4 hours later (at 12:00 PM) on this day. No G-CSF will be administered.
16222382|NCT01220362|Drug|Bupivacain 0.125%|Bupivacain 0.125%
16222383|NCT01220362|Drug|Bupivacain 0.125%/Fentanyl 2mcg/ml|Bupivacain 0.125%/Fentanyl 2mcg/ml
16222384|NCT01220349|Device|Echocardiographic 2D strain analysis|Conventional transthoracic echocardiography with acquisitions for strain analysis by speckle tracking (2D strain)
16222385|NCT01220336|Behavioral|Health coaching by medical assistants in primary care|Patients with uncontrolled diabetes, hypertension, hyperlipidemia will receive health coaching by medical assistants working with primary care providers in the Teamlet Model [Bodenheimer 2007] for 12 months.
16222386|NCT01220323|Device|direct current stimulation|Patients will receive sham tDCS or real tDCS in a 5-day period of treatment in a randomized, sham controlled study. The participants will be divided to 2 groups of 50 each. One group will receive 5 days period of 20 min 2mA tDCS over the lt M1 and the other will receive sham stimulation. X week later the groups will switch to the other arm
16222387|NCT01220323|Device|direct current stimulation|Patients will receive sham tDCS or real tDCS in a 5-day period of treatment in a randomized, sham controlled study. The participants will be divided to 2 groups of 50 each. One group will receive 5 days period of 20 min 2mA tDCS over the lt M1 and the other will receive sham stimulation. X week later the groups will switch to the other arm
16222388|NCT01220310|Behavioral|Online diabetes workshop observation and learning sessions|We will, by self-administered pre- and post-intervention surveys, evaluate the effectiveness of the online diabetes workshop observations and learning sessions.
16222389|NCT01220297|Drug|Sirolimus|"Immunosuppressant administered orally to:
~Adults (age 14 and older), beginning on Day -3 with 12 mg loading dose, followed by 4 mg/day.
~Children < 13 years or weighing 40 kg, beginning on Day -3 with 3 mg/m² loading dose, followed by 1 mg/ m², rounded to the nearest full milligram.
~Daily dosage may be adjusted to maintain a target serum trough level of 3 to 12 ng/ml. Sirolimus dose tapering will begin at Day 100 in the absence of GvHD, with the goal of discontinuation by 6 months."
16222390|NCT01220297|Drug|Mycophenolate mofetil (MMF)|Immunosuppressant given intravenously (IV) at 15 mg/kg 3 times daily, starting on Day 0 ≥ 2 hr after the completion of the HSCT infusion. Dose of MMF will be based on actual body weight, but limited to 15 kg above ideal body weight. MMF dose tapering will begin at Day 100 in the absence of GvHD, with the goal of discontinuation by 6 months.
16222391|NCT01220297|Drug|Carmustine|For Carmustine + Etoposide + Cyclophosphamide cohort, chemotherapy administered IV on Day -6 at the lesser of 15 mg/kg or 550 mg/m².
16222392|NCT01220297|Drug|Etoposide|For Carmustine + Etoposide + Cyclophosphamide cohort, chemotherapy administered IV on Day -4 at 60 mg/kg
16222393|NCT01220297|Drug|Cyclophosphamide (Cyclo, CY)|"Cyclophosphamide is a chemotherapy agent.
~For FTBI + Cyclophosphamide cohort, administered IV on Day -3 and -2 at 60 mg/kg.
~For Carmustine + Etoposide + Cyclophosphamide cohort, administered IV on Day -2 at 100 mg/kg"
16222394|NCT01220297|Drug|FTBI|For FTBI + Cyclophosphamide cohort, administered as 1320 cGy delivered in 11 120 cGy fractions over 4 days starting on Day -7.
16222395|NCT01220284|Drug|Satraplatin in combo with vinorelbine|"Satraplatin (gelatin capsules) p.o. on days 1 to 5 (from 60 mg/m2 up to 80 mg/m2)
~Vinorelbine (soft capsules) p.o. on days 1, 8 and 15 (from 60 mg/m2 up to 80 mg/m2) The treatment is repeated every 4 weeks."
16222396|NCT01220271|Drug|LY2157299|Administered orally
16222397|NCT01220271|Drug|Radiation|Administered as approved
16222398|NCT01220271|Drug|Temozolomide|Administered orally
16222399|NCT01220258|Drug|Azithromycin ophthalmic solution, 1%|1 drop twice daily (BID) for the first 2 days and then 1 drop once daily (QD) for the remainder of treatment period (approximately 28 days total)
16222400|NCT01220245|Procedure|Heparin-bonded ePTFE endoluminal fem-pop bypass|Heparin-bonded ePTFE endoluminal femoropopliteal bypass versus surgical femoropopliteal bypass
16222401|NCT01220245|Procedure|Surgical femoro-popliteal bypass.|Surgical femoro-popliteal bypass.
16222402|NCT01220232|Drug|Abacavir/Lamivudine|Abacavir/Lamivudine 600/300 mg QD for 5 days
16222403|NCT01220232|Drug|Abacavir/Lamivudine|Abacavir/Lamivudine 600/300 mg QD for 10 days
16222404|NCT01220232|Drug|Lersivirine|Lersivirine 750 mg QD for 10 days
16222405|NCT01220219|Drug|Pregabalin controlled release, 82.5 mg|Two tablets of 82.5 mg controlled release (administered concurrently) once daily for four days.
16222406|NCT01220219|Drug|Pregabalin controlled release, 165 mg|165 mg controlled release tablet administered once daily for four days.
16222407|NCT01220219|Drug|Pregabalin immediate release, 75mg|75 mg immediate release capsule administered every 12 hours for four days
16222408|NCT01220206|Drug|Placebo|2 placebo capsules daily
16222409|NCT01220206|Drug|One POMx capsule daily|One POMx capsule, one placebo capsule daily
16222410|NCT01220206|Drug|2 POMx Capsules|2 POMx Capsules daily
16222411|NCT01220180|Drug|pregabalin (Lyrica)|Pregabalin treatment can be started with a dose of 150 mg per day. Based on individual subject response and tolerability, the dosage may be increased to 300 mg per day after 1 week. The maximum dosage of 600 mg per day may be achieved after an additional week.
16222412|NCT01220180|Drug|pregabalin (Lyrica)|"Peripheral neuropathic pain: Pregabalin treatment can be started at a dose of 150 mg per day. Based on individual subject response and tolerability, the dosage may be increased to 300 mg per day after an interval of 3 to 7 days, and if needed, to a maximum dose of 600 mg per day after an additional 7-day interval.
~Central neuropathic pain: Pregabalin treatment can be started at a dose of 150 mg per day. Based on individual subject response and tolerability, the dosage may be increased to 300 mg per day after an interval of 1 week, and if needed, to a maximum dose of 600 mg per day after an additional 1 week interval. In case that tolerability could not be shown in the targeted daily dose, dose reduction may be considered."
16222413|NCT01220180|Drug|pregabalin (Lyrica)|The recommended dose of pregabalin for fibromyalgia is 300 to 450 mg/day. Dosing should begin at 75 mg two times a day (150 mg/day) and may be increased to 150 mg two times a day (300 mg/day) within 1 week based on efficacy and tolerability. Subjects who do not experience sufficient benefit with 300 mg/day may be further increased to 225 mg two times a day (450 mg/day). Treatment with doses above 450 mg/day is not recommended.
16222414|NCT01220167|Drug|Ondansetron 8 mg ODFS without water|Single dose of Ondansetron 8 mg (ODFS) administered without water
16222415|NCT01220167|Drug|Ondansetron 8 mg ODFS with water|Single dose of Ondansetron 8 mg (ODSF) was orally administered, allowed to dissolve, swallowed with saliva, followed with water
16222416|NCT01220167|Drug|Zofran ODT (ondansetron 8 mg) without water|Single dose of Zofran ODT (containing ondansetron 8 mg) administered without water
16222417|NCT01220154|Drug|Paclitaxel|Cycle 1 Day 1, 8, 15 IV 60-80mg mg/m2 as a 1 hour infusion. For cycle 2-6 Day 1,8,15 IV 60-80 mg/m2 as 1 hour infusion. Repeat every 3 weeks times 5 cycles.
16222418|NCT01220154|Drug|Carboplatin|Intraperitoneal Day 1 cycles 1-6 AUC
16222419|NCT01220154|Drug|Bevacizumab|Bevacizumab 15 mg/kg intravenous infusion Day 1 cycles 2-6 Optional cycles 7-22 15 mg/kg intravenous infusion Day 1 every 21 days
16222420|NCT01220141|Drug|activated recombinant human factor VII|Administration of room temperature stable NovoSeven® (activated recombinant human factor VII) in dosages prescribed by the treating physician according to the product labelling text approved in his country.
16222421|NCT01220128|Biological|GSK Biologicals' recombinant WT1 Antigen-Specific Cancer Immunotherapeutic (ASCI) GSK2302024A|6 or 8 injections at 3 weeks apart, injected intramuscularly in the deltoid or lateral region of the thigh.
16222422|NCT01220128|Drug|Placebo|6 or 8 doses at 3 weeks apart of sucrose/mannitol-based formulation reconstituted with an oil-in-water emulsion, injected intramuscularly in the deltoid or lateral region of the thigh.
16222423|NCT01220128|Drug|Aromatase inhibitor|This treatment consisted of any aromatase inhibitor (e.g. letrozole or exemestane), administered intravenously in Cohort A Groups daily for either 18 (if 6 doses of WT1 ASCI/placebo) or 24 weeks (if 8 doses of WT1 ASCI/placebo).
16222424|NCT01220128|Drug|5-Fluorouracil|Administered intravenously in Cohorts A Placebo, B, C and D/E Groups: for the 6 WT1 ASCI-dose schedule 3 doses at 3 weeks apart, and for the 8 WT1 ASCI-dose schedule 4 doses at 3 weeks apart. For Cohorts A Placebo, B and C Groups, the administration was on the same day as the administration of WT1 ASCI/placebo (Day 1 of each cycle). For Cohort D/E Groups, the administration was on Day 14 of each cycle.
16222425|NCT01220128|Drug|Carboplatin AUC|Administered intravenously in Cohort C Groups in 6 doses at 3 weeks apart, on the same day as WT1 ASCI/placebo administration (Day 1 of each cycle).
16222426|NCT01220128|Drug|Cyclophosphamide|Administered intravenously in Cohorts A Placebo, B, C and D/E Groups: for the 6 WT1 ASCI-dose schedule 3 doses in Cohort C Groups and 6 doses 3 weeks apart in Cohorts A Placebo, B and D Groups, while for the 8 WT1 ASCI-dose schedule 4 doses at 3 weeks apart. For Cohorts A Placebo, B and C Groups, the administration was on the same day as the administration of WT1 ASCI/placebo (Day 1 of each cycle). For Cohort D/E Groups, the administration was on Day 14 of each cycle.
16222427|NCT01220128|Drug|Docetaxel|Administered intravenously in Cohorts A Placebo, B, C and D/E Groups: for the 6 WT1 ASCI-dose schedule 3 or 6 doses 3 weeks apart, while for the 8 WT1 ASCI-dose schedule 4 doses at 3 weeks apart. For Cohorts A Placebo, B and C Groups, the administration was on the same day as the administration of WT1 ASCI/placebo (Day 1 of each cycle). For Cohort D/E Groups, the administration was on Day 14 of each cycle.
16222428|NCT01220128|Drug|Doxorubicin|Administered intravenously in Cohorts A Placebo, B, C and D/E Groups: for the 6 WT1 ASCI-dose schedule 6 doses 3 weeks apart (Cohort C patients with this schedule did not receive this treatment), while for the 8 WT1 ASCI-dose schedule 4 doses at 3 weeks apart. For Cohorts A Placebo, B and C Groups, the administration was on the same day as the administration of WT1 ASCI/placebo (Day 1 of each cycle). For Cohort D/E Groups, the administration was on Day 14 of each cycle.
16222429|NCT01220128|Drug|Epirubicin|Administered intravenously in Cohorts A Placebo, B, C and D/E Groups: for the 6 WT1 ASCI-dose schedule 3 doses 3 weeks apart, while for the 8 WT1 ASCI-dose schedule 4 doses at 3 weeks apart. For Cohorts A Placebo, B and C Groups, the administration was on the same day as the administration of WT1 ASCI/placebo (Day 1 of each cycle). For Cohort D/E Groups, the administration was on Day 14 of each cycle.
16222430|NCT01220128|Drug|Paclitaxel|Administered intravenously in Cohorts A Placebo, B, C and D/E Groups: only in the 8 WT1 ASCI-dose schedule patients received 4 at 3 weeks apart or 12 weekly doses. For Cohorts A Placebo, B and C Groups, the administration was on the same day as the administration of WT1 ASCI/placebo (Day 1 of each cycle). For Cohort D/E Groups, the administration was on Day 14 of each cycle.
16222431|NCT01220128|Drug|Trastuzumab|Administered intravenously in Cohort C Groups: for the 6 WT1 ASCI-dose schedule 3 or 6 doses 3 weeks apart, while for the 8 WT1 ASCI-dose schedule 4 doses at 3 weeks apart. For Cohort B and C Groups, the administration was on the same day as the administration of WT1 ASCI/placebo (Day 1 of each cycle). For Cohort D/E Groups, the administration was on Day 14 of each cycle.
16222432|NCT01220102|Drug|0.1% adapalene/ 2.5% benzoyl peroxide|topical application, once per day
16222433|NCT01220089|Behavioral|Standard maintenance|Participants will receive written materials in months 7-18
16222434|NCT01220089|Behavioral|Intensified maintenance|Participants will continue with in-person counseling visits in months 7-18
16222435|NCT01220076|Drug|tamoxifen|
16222436|NCT01220063|Radiation|Radiation|10 Gy for 4 times (total 40 Gy)
16222437|NCT01220063|Drug|Irinotecan|40 mg/m² : Day 1 and day 8
16222438|NCT01220050|Drug|Paricalcitol|Paricalcitol capsules 1- 2 mcg/day/pts for 26 weeks
16222439|NCT01220050|Drug|Standard therapy|Standard therapy for hyperparathyroidism for 26 weeks
16222535|NCT01219192|Drug|M2ES|M2ES IV D1,8,15,21 every 28 days a cycle
16222440|NCT01220037|Behavioral|Adhere to a specific standardized diet for 4 days|24 h before the start of the intervention all subjects will adhere to a standardized diet for 4 days. Young subjects are randomly allocated to either a low protein diet, regular protein diet or high protein diet group. All elderly subjects will adhere to a regular protein diet comparable to the regular protein diet of the young subjects.
16222441|NCT01220024|Drug|Bupivacaine Collagen Sponge|Drug: Bupivacaine Collagen Sponge
16222442|NCT01220024|Drug|Placebo collagen Sponge|Drug: Placebo Collagen Sponge
16222443|NCT01220011|Procedure|Fetoscopic laser surgery|Fetoscopic laser surgery
16222444|NCT01219985|Other|standard and respiratory-gated PET acquisitions|"After fasting for at least 6 hours, normal glucose blood level was checked and each patient received an intravenous injection of 18F-FDG (5MBq/kg). After a 60-minute uptake phase in a quiet environment, patients underwent the PET/CT examination.
~Whole-body PET/CT (Ungated session) The Ungated acquisition consisted in a whole-body, free-breathing CT followed by standard multistep PET, used as routine clinical practice in the department.
~Respiratory-gated PET/CT (CT-based session) The CT-based method consisted in an additional single-step, 10-minute List Mode respiratory gated PET acquisition followed by an end-expiration breath-hold CT added to the end of the clinical protocol, with continuous respiratory signal recording during these examinations."
16222445|NCT01219959|Drug|Dianeal|Dianeal 1.5% dextrose, 2.5% dextrose, 4.25% dextrose
16222446|NCT01219959|Drug|Dianeal, Extraneal, Nutrineal|Dianeal 1.5% dextrose, 2.5% dextrose, 4.25% dextrose, Nutrineal 1.1% Amino Acids, Extraneal 7.5% Icodextrin
16222447|NCT01219933|Drug|methylprednisolone|starting dose >/= 1 mg and </= 20 mg orally daily, according to dose-reduction schedule
16222448|NCT01219933|Drug|tocilizumab [RoActemra/Actemra]|background therapy: 8 mg/kg iv every 4 weeks
16222449|NCT01219920|Drug|FOLFIRI|Irinotecan 180 mg/sqm on day 1 Leucovorin 100 mg/sqm on day 1 and day 2 5-fluorouracil 400 mg/sqm bolus followed by 5-fluorouracil 600 mg/sqm 22-hour continuous infusion on day 1 and day 2 Repeated every 2 weeks
16222450|NCT01219920|Drug|FOLFOXIRI|Irinotecan 165 mg/sqm on day 1 Oxaliplatin 85 mg/sqm on day 1 Leucovorin 200 mg/sqm on day 1 5-fluorouracil 3200 mg/sqm 48-hour continuous infusion starting on day 1 Repeated every 2 weeks
16222451|NCT01219907|Biological|HER-2/neu peptide vaccine|Given intradermally
16222452|NCT01219907|Drug|cyclophosphamide|Given IV
16222453|NCT01219907|Biological|ex vivo-expanded HER2-specific T cells|Given IV
16222454|NCT01219907|Other|laboratory biomarker analysis|Correlative studies
16222455|NCT01219907|Other|flow cytometry|Correlative studies
16222456|NCT01219907|Other|immunoenzyme technique|Correlative studies
16222457|NCT01219881|Drug|Desflurane|5.4 to 7.4% desflurane
16222458|NCT01219881|Drug|Sevoflurane|1.4 to 2.5% Sevoflurane
16222459|NCT01219868|Behavioral|Physician-nurse team supervision|Physician-nurse team will supervise patient's flow in the ED
16222460|NCT01219855|Drug|Cohort 1 CTAP101 Capsules- 60µg|60µg of CTAP101 capsules given once daily for 42 days.
16222461|NCT01219855|Drug|Cohort 1 CTAP101 Capsules - 90µg|90µg of CTAP101 capsules given once daily for 42 days.
16222462|NCT01219855|Drug|Cohort 1 Matching Sugar Capsule|Placebo capsules given once daily for 42 days.
16222463|NCT01219855|Drug|Cohort 2 CTAP101 Capsules - 30µg|30µg of CTAP101 capsules given once daily for 42 days.
16222464|NCT01219855|Drug|Cohort 2 Matching Sugar Capsule|Placebo capsules given once daily for 42 days.
16222465|NCT01219842|Procedure|INVASIVE (INV) treatment|Modern endovascular and/or open revascularisation according to the TASC II recommendations.
16222466|NCT01219842|Other|Best medical treatment (BMT)|Antiplatelet therapy, cilostazol and non-supervised exercise training. Smoking cessation support. Lipid-lowering therapy, diabetes and hypertension treated according to current national guidelines.
16222467|NCT01219816|Drug|Epratuzumab|Combination of chemotherapy + Epratuzumab
16222468|NCT01219816|Drug|Epratuzumab|Vincristine + Dexamethasone + Epratuzumab
16222469|NCT01219803|Drug|High Dose GGQL Decoction|The drug was a kind of decoction extracted by Chinese herbs such as Huanglian etc,5 times thick of low dose GGQL Decoction, 150ml/bag, twice in a day
16222470|NCT01219803|Drug|Mild dose GGQL Decoction|The drug was a kind of decoction extracted by Chinese herbs such as Huanglian etc,3 times thick of low dose GGQL Decoction, 150ml/bag, twice in a day
16222471|NCT01219803|Drug|Low dose GGQL Decoction|The drug was a kind of decoction extracted by Chinese herbs such as Huanglian etc, 150ml/bag, twice in a day
16222472|NCT01219803|Drug|Placebo|The placebo was a kind of decoction,which including 4.5% low dose GGQL Decoction to feel bitter taste as other drugs, 150ml/bag, twice in a day
16222473|NCT01219790|Radiation|external radiotherapy|All patients receive a total dose of 27 Gy divided into 3 fractions of 9 Gy performed at least 48 hours apart each, for a treatment to J1, J3 and J5
16222474|NCT01219790|Drug|Acide zoledronic|The administration of zoledronic acid as defined under the Authorisation on the Market.
16222475|NCT01219777|Drug|carboplatin|Carboplatin AUC 5.0 or 6.0 will be administered on day 1 during cycle 1-3. Treatment cycle consists of 21 days duration.
16222476|NCT01219777|Drug|Bevacizumab|Bevacizumab 15 mg/kg administered on Day 1 during cycle 1-3. Treatment cycle consists of 21 days duration.
16222477|NCT01219777|Drug|Paclitaxel|60-80 mg/m2 administered on Day 1, 8 & 15 during cycle 1-3. Treatment cycle consists of 21 days duration.
16222478|NCT01219764|Drug|Rabeprazole, metronidazole, Clarithromycin, Amoxicillin|"Full dose arm:Rabeprazole (20mg), metronidazole (500mg), Clarithromycin (500mg) and Amoxicillin (1000mg) twice daily for a period of 7 days.
~Half dose arm: Rabeprazole (10mg), metronidazole (250mg), Clarithromycin (250mg) and Amoxicillin (500mg) twice daily for a period of 7 days."
16222479|NCT01219751|Drug|Sunitinib|Sunitinib 50 mg D1-D28 every 6 weeks
16222480|NCT01219738|Drug|Budesonide 360ug|A single inhaled dose of 360ug budesonide from a DPI.
16222481|NCT01219738|Drug|Budesonide 720ug|A single inhaled dose of 720ug budesonide from a DPI.
16222482|NCT01219738|Drug|Budesonide 1440ug|A single dose of 1440ug of the budesonide from DPI.
16222483|NCT01219738|Drug|Budesonide720ug 4 times|720ug of budesonide will be inhaled by the subjects 4 times, separated by 30 minutes.
16222484|NCT01219738|Drug|Placebo|A single inhaled dose of placebo from a DPI.
16222485|NCT01219725|Behavioral|Exercise training|6 months of moderate intensity exercise training 3 times per week
16222486|NCT01219712|Procedure|Colloids, dobutamin, levosimendan|": The main aim of goal-directed therapy is to achieve a normal oxygen delivery to the tissues i.e. DO2 500-600ml/min/m2.
~Hb would be optimized to > 90 g/l
~SaO2 > 96%
~Stroke volume index (SVI) > 30
~Heart rate should ideally be < 80
~Stroke volume index (SVI) > 30 is achieved by repeated volume substitution in the form of 100-200 ml colloid. If, despite bolus doses of colloids, the SVI is < 30, one would have to use ionotropic drugs e.g. dobutamine or levosimendan, in order to achieve this goal"
16222487|NCT01219699|Drug|BYL719|BYL719 is an oral α-specific phosphatidylinositol-3-kinase (PI3K) inhibitor.
16222488|NCT01219699|Drug|Fulvestrant|"In adult patients with advanced solid malignancies whose tumors have an alteration (mutation or amplification) of the PIK3CA gene.
~Fulvestrant is an estrogen receptor antagonist, administered by monthly intramuscular injection"
16222489|NCT01219686|Drug|escitalopram, pindolol|escitalopram p.o., once daily, day 1-2: 10mg, days 3-42: 20mg pindolol p.o., twice daily 7.5 mg days 1-14, once daily 7.5 mg days 15-17
16222490|NCT01219686|Drug|escitalopram|escitalopram p.o., once daily. days 1-2: 10 mg, days 3-4: 20 mg, days 5-42: 30 mg
16222491|NCT01219686|Drug|escitalopram|escitalopram 20 mg, p.o., once daily. Days 1-2: 10mg, days 3-42: 20 mg
16222492|NCT01219673|Other|Placebo|1 by mouth twice a day.
16222493|NCT01219673|Drug|Armodafinil|150 mg by mouth once a day.
16222494|NCT01219673|Drug|Minocycline|100 mg by mouth twice a day.
16222495|NCT01219673|Drug|Bupropion|100 mg by mouth twice a day.
16222496|NCT01219647|Behavioral|exercise|subjects will participate in one of two forms of exercise
16222497|NCT01219647|Behavioral|stretching|subjects will particiopate in supervised stretching as described in arm description.
16222498|NCT01219621|Procedure|Symphony Dual Chamber Rate Responsive Device|Echocardiography ANP/BNP measurements
16222499|NCT01219608|Dietary Supplement|Glutamine 0.5 g/kg/day|Glutamine 0.5 g/kg/day
16222500|NCT01219608|Dietary Supplement|Glutamine 1 g/kg/day|Glutamine 1 g/kg/day
16222501|NCT01219608|Dietary Supplement|Enteral Nutrition|Ordinary Enteral Nutrition
16222502|NCT01219595|Other|Sweetened, dried cranberries|Women in Arm 1 will consume one serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for two weeks.
16222503|NCT01219595|Other|Strawberry Fruit Pieces|1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for three separate, two-week periods. Each two week period will be separated by a two-week interval.
16222504|NCT01219595|Other|Sweetened, dried cranberries|1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for three separate, two-week periods. Each two week period will be separated by a two-week interval.
16222505|NCT01219595|Other|Sweetened, dried cranberries|1 serving (1/3 cup; 42 g) of sweetened, dried cranberries each day for one 4-week period.
16222506|NCT01219595|Other|Strawberry Fruit Pieces|1 serving (1/3 cup; 42 g) of strawberry fruit pieces each day for one 4-week period.
16222507|NCT01219595|Other|Observation|Subjects in the non-UTI susceptible group will have one visit where one vaginal and one rectal swab will be collected.
16222508|NCT01219582|Drug|Glucobay M (Acarbose/Metformin, BAY81-9783)|Oral Glucobay-M 25 every 8 hours (Q8H) titrated to Glucobay-M 50 Q8H or as per investigators discretion.
16222509|NCT01219569|Drug|propofol|Propofol infusion 120 and 160 mcg/kg/min in random sequence during the operative procedure
16222510|NCT01219569|Drug|Sevoflurane|sevoflurane 1.5% and 2.5% end tidal in random sequence
16222511|NCT01219556|Drug|Olmesartan plus hydrochlorothiazide (Xirtam H, BAY98-7105)|Oral Xirtam H tablets every 24 hours (Q24H) or as per prescribing information
16222512|NCT01219543|Drug|AZD1480 Daily|Oral Dose, Capsule, Daily Dosing
16222513|NCT01219543|Drug|AZD1480 BID|Oral Dose, Capsule, BID Dosing
16222514|NCT01219517|Other|Polar body and embryo biopsy|2 polar bodies and all embryos will be biopsied prior to embryo transfer.
16222515|NCT01219465|Biological|umbilical cord mesenchymal stem cells|Transfusion of the umbilical cord mesenchymal stem cells (2 x 107 cells) intravenously.
16222516|NCT01219452|Biological|umbilical cord mesenchymal stem cells|Multiple intra muscular injection of mesenchymal stem cells derived from human umbilical cord.
16222517|NCT01219426|Other|Filling of three questionnaires|The only intervention of the study was the completion of the three questionnaires, and of a mini-questionnaire assessing gender, age, and gambling activities.
16222518|NCT01219413|Drug|Aliskiren, Perindopril|Rasilez 300 mg Prestarium 10 mg
16222519|NCT01219400|Drug|Vildagliptin|Vildagliptin (50 mg BID) given for four weeks
16222520|NCT01219348|Biological|IDO peptide vaccination|Vaccination every second week
16222521|NCT01219322|Drug|Sodium bicarbonate|single use of sodium bicarbonate and sterile water for injection 1:1 concentration 50 cc
16222522|NCT01219322|Drug|normal saline|intravenous normal saline volume equivalent to sodium bicarbonate
16222523|NCT01219309|Dietary Supplement|Omega 3/6 fatty acids|3 capsules bid orally
16222524|NCT01219309|Dietary Supplement|Placebo (olive oil)|3 capsules bid orally
16222525|NCT01219257|Biological|Anti-TNF alpha therapy|All medical treatment will be standardizes following good medical practice
16222526|NCT01219244|Behavioral|caloric restriction|6 months of caloric restriction (15 %)
16222527|NCT01219244|Behavioral|omega-3 supplementation|6 months of omega-3 supplementation
16222528|NCT01219244|Behavioral|resveratrol supplementation|6 months of resveratrol supplementation
16222529|NCT01219244|Behavioral|Placebo|6 months of placebo intake
16222530|NCT01219244|Behavioral|2nd step: intervention + physical / cognitive training|most effective dietary intervention plus physical and cognitive training
16222531|NCT01219244|Behavioral|2nd step: intervention + control|most effective dietary intervention plus control
16222532|NCT01219231|Behavioral|Exercise|6 months of aerobic exercise
16222533|NCT01219218|Device|Cardiac Extracorporeal Shockwave Therapy generator (Cardiospec)|Energy Density - 0.09 mJ/mm2
16222534|NCT01219205|Procedure|intravitreal bevacizumab|Intravitreal injections of bevacizumab were performed under sterile conditions in the operating room. a 27-gauge needle was inserted through the corneal limbus to withdraw 0.05 ml of aqueous humor and soften the globe. Then, 1.25 mg (0.05 ㎖) of bevacizumab was injected into the vitreous in the superior temporal quadrant with a 30-gauge needle that was inserted into the eye 3.5 mm from the limbus. The postoperative medications included topical antibiotics.
16222539|NCT01219179|Other|Sterile water feedings|"Control group- no intervention
~Prophylactic group will receive sterile water feeds starting at 24 hours of life if/or when their serum sodium value is ≥ 145 mEq/L. The volume of sterile water is 10mls/Kg/day based on birth weight, given via continuous infusion feed.
~The feeding will be stopped when the serum sodium value is ≤ 140 mEq/L.
~The hypernatremia group will receive sterile water feeds when their serum sodium value is ≥ 150 meq/L. The volume of sterile water is 10 mls/Kg/day based on birth weight,given via continuous infusion feed. The feeding will be stopped when the serum sodium value is ≤ 140 mEq/L."
16222540|NCT01219166|Procedure|Laparoscopic Cholecystectomy|Laparoscopic Cholecystectomy
16222541|NCT01219153|Drug|Extended high dose letrozole regimen /GnRH antagonist protocol|"Letrozole (Femara; Novertis pharma AG, Basle, Switzerland) is administered starting on cycle day one for 8 consecutive days . The dose of letrozole is 5mg /day during the first 5 days of cycle and 2.5 mg/day during the subsequent 3 days .
~Highly purified urinary FSH (HP-uFSH) (Fostimon, IBSA) 300 IU/day is started on cycle day 5 and is continued until and including the day of HCG administration. Starting from cycle day 8 , the dose of HP-uFSH is adjusted individually according to ovarian response which is monitored using transvaginal ultrasound and serum estradiol.
~GnRH antagonist (cetrorelix acetate)(Cetrotide®) 0.25 mg S.C once daily is started when the leading follicle is 14 mm in mean diameter and is continued until and including the day of HCG administration ."
16222542|NCT01219153|Drug|Short low dose letrozole regimen /GnRH antagonist protocol|"Letrozole (Femara; Novertis pharma AG, Basle, Switzerland)2.5 mg /daily is administered for 5 consecutive days starting on cycle day 3.
~Highly purified urinary FSH (HP-uFSH) (Fostimon, IBSA) 300 IU/day is started on cycle day 3 and is continued until and including the day of HCG administration. Starting from cycle day 8 , the dose of HP-uFSH is adjusted individually according to ovarian response which is monitored using transvaginal ultrasound and serum estradiol.
~GnRH antagonist (cetrorelix acetate)(Cetrotide®) 0.25 mg S.C once daily is started when the leading follicle is 14 mm in mean diameter and is continued until and including the day of HCG administration ."
16222543|NCT01219140|Dietary Supplement|2 POMx Capsules|2 POMx Capsules daily
16222544|NCT01219140|Dietary Supplement|2 placebo Capsules|2 placebo Capsules daily
16222545|NCT01219127|Other|Derma-PACE|ESWT group received derma-PACE shockwave treatment 2 x 1 wk for 3 wks for a total of 6 treatment using derma-PACE dervice (Alpharetta, GA). HBO groups received HBOT daily 5 days a week for 8 weeks or a total of 40 treatments.
16222546|NCT01219101|Drug|clomiphene citrate with ethinyl esteradiol|Clomiphene citrate is used in combination of ethinyl estradiol (0.05 mg for 5 days) for induction ovulation of polycystic ovary syndrome women undergoing intrauterine insemination
16222547|NCT01219101|Drug|clomiphene citrate with plasebo|Clomiphene citrate is used in combination of placebo (for 5 days) for induction ovulation of polycystic ovary syndrome women undergoing intrauterine insemination
16222548|NCT01219088|Drug|Bupivacaine, morphine|1.8-2.5 mL of 0.5% heavy bupivacaine for spinal anesthesia 20 mL of 0.25% bupivacaine for femoral nerve block 0.1 mg of intrathecal morphine 20 mL of 0.25% bupivacaine for periarticular infiltration
16222549|NCT01219075|Dietary Supplement|soy isoflavones|Given orally
16222550|NCT01219075|Other|placebo|Given orally
16222551|NCT01219075|Other|questionnaire administration|Ancillary studies
16222552|NCT01219075|Procedure|magnetic resonance imaging|Correlative studies
16222553|NCT01219075|Procedure|biopsy|Correlative studies
16222554|NCT01219075|Other|immunohistochemistry staining method|Correlative studies
16222555|NCT01219075|Other|laboratory biomarker analysis|Correlative studies
16222556|NCT01219075|Procedure|mammography|Correlative studies
16222557|NCT01219062|Drug|morphine|periarticular infiltration with 0.25% Bupivacaine for 20 ml.
16222558|NCT01219062|Other|control|the patients will be received spinal anesthesia with 0.5% Isobaric Bupivacaine and postoperative pain control by intravenous (IV) Patient - control Analgesia (PCA)
16222559|NCT01219062|Drug|Bupivacaine|the patients will be received spinal anesthesia and periarticular tissue infiltration with 0.25% Bupivacaine and postoperative pain control by IV PCA
16222560|NCT01219049|Drug|Tyrosine|1000 mg / day
16222561|NCT01219049|Drug|Tyrosine|2000 mg / day
16222562|NCT01219049|Drug|Placebo|Placebo daily
16222563|NCT01219036|Drug|Budesonide (directly observed)|Budesonide 1600 micrograms daily directly observed for 7 days
16222564|NCT01219023|Drug|sildenafil citrate|Subjects will be given 2 types of topical creams, one containing 1% sildenafil and one containing placebo control. Subjects will be randomized to apply sildenafil cream to either the right or left hand/foot; placebo cream will be applied to the opposite hand/foot. The cream will be supplied to subjects with proper labeling to indicate right and left application assignment. Cream will be applied to each affected hand/foot two times per day.
16222565|NCT01219010|Biological|Siltuximab|15mg/kg IV infusion every 3 weeks for 4 cycles. If applicable extended dosing of 15 mg/kg IV infusion every 4 weeks for up to 2 years.
16222566|NCT01218997|Drug|Medisorb naltrexone 380 mg|Administered via intramuscular (IM) injection once every 4 weeks for up to 1 year.
16222567|NCT01218997|Drug|Oral naltrexone 50 mg|Tablet taken orally once daily for up to 1 year
16222568|NCT01218984|Drug|Medisorb naltrexone 75 mg|Single administration via intramuscular (IM) injection.
16222569|NCT01218984|Drug|Medisorb naltrexone 150 mg|Single administration via IM injection.
16222570|NCT01218984|Drug|Medisorb naltrexone 300 mg|Single administration via IM injection.
16222571|NCT01218984|Drug|Hydromorphone (10 mg/mL)|Increasing doses of 0, 3, 4.5, and 6 mg were administered at baseline (pre-study drug administration). After study drug administration, additional hydromorphone challenge sessions consisting of administering 0, 3, 4.5, and 6 mg were administered at 1-hr intervals at each of the postdose evaluation visits. In addition, at a randomly selected evaluation visit, subjects received four 0 mg (placebo) doses at 1-hour intervals.
16222572|NCT01218984|Drug|Naloxone Challenge and Oral Naltrexone Tolerability Testing|Administered according to the instructions provided by the respective manufacturer. Testing occurred at least 7 days after the baseline hydromorphone challenge and prior to study drug administration.
16222573|NCT01218971|Drug|Medisorb naltrexone 190 mg|naltrexone for extended-release injectable suspension
16222574|NCT01218971|Drug|Medisorb naltrexone 380 mg|naltrexone for extended-release injectable suspension
16222840|NCT01217151|Other|Usual treatment|Hemodynamic monitoring based on common practice
16222576|NCT01218958|Drug|Medisorb naltrexone 380 mg|IM injection once every 4 weeks for a total of 6 administrations.
16222577|NCT01218958|Drug|Placebo matching Medisorb naltrexone 190 mg|IM injection once every 4 weeks for a total of 6 administrations.
16222578|NCT01218958|Drug|Placebo matching Medisorb naltrexone 380 mg|IM injection once every 4 weeks for a total of 6 administrations.
16222579|NCT01218945|Procedure|Cell Culture|Aim of this study is to isolate and cultivate fat-derived progenitor cells and differentiation into osteoblasts. Therefore, our research idea is to pre-engineer large synthetic bone grafts and study the vascularization process in vivo.
16222580|NCT01218932|Drug|A|Subjects in A group who receive regimen 1 of primaquine (PQ) on the first admission (visit 2) will receive regimen 2 of primaquine and chloroquine combination (PQ and CQ) on second admission (visit 3) after 1 week wash out period and will finish with regimen 3 of Chloroquine (CQ) on the third admission (visit 4) after 8 weeks wash out period.
16222581|NCT01218932|Drug|B|Subjects in B group who receive regimen 1 of primaquine ( PQ) will receive regimen 2 of chloroquine (CQ) on second admission (visit 3) after 1 week wash out period and regimen 3 of primaquine and chloroquine combination (PQ and CQ)on third admission( visit 4) with 8 week wash out period in between.
16222582|NCT01218893|Drug|Chloroquine prophylaxis|The chloroquine dose used will be 300mg for the first two days, followed by 300mg per week, for 13 weeks.
16222583|NCT01218893|Biological|Immunization|All groups will be immunised with mosquitobites. The number of infected mosquitoes differs per group, as clarified in group description.
16222584|NCT01218893|Biological|Plasmodium falciparum challenge|Exposure to the bites of 5 Plasmodium falciparum infected mosquitoes.
16222585|NCT01218893|Drug|Malarone treatment|When thick smear positive, of ar day 21 after challenge, all volunteers will be treated with malarone.
16222586|NCT01218880|Drug|M2ES 7.5mg|M2ES Dosage：7.5mg/m2
16222587|NCT01218880|Drug|M2ES 15mg|M2ES Dosage：15mg/m2
16222588|NCT01218880|Drug|M2ES 30mg|M2ES Dosage：30mg/m2
16222589|NCT01218880|Drug|M2ES 45mg|M2ES Dosage：45mg/m2
16222590|NCT01218867|Biological|Anti-VEGFR2 CAR CD8 plus PBL|Patients will receive non-myeloablative lymphodepleting preparative regimen consisting of cyclophosphamide and fludarabine followed by the administration of anti-VEGFR CAR CD8+ PBL and high dose (Arms 1-7) or low dose (Arms 8-11) aldesleukin. On day 0, cells will be infused in the Patient Care Unit over 20-30 minutes (Phase 1: 10e6- 3x10e10 cells and Phase 2: maximum tolerated dose of cells from Phase 1)
16222591|NCT01218867|Drug|Cyclophosphamide|Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml dextrose in 5% water (D5W) with mesna 15 mg/kg/day X 2 days over 1 hr
16222592|NCT01218867|Biological|Aldesleukin|Aldesleukin (based on total body weight) will be administered at a dose of 720,000 IU/kg (Arms 1-7) or 72,000 IU/kg (Arms 8-11) as an intravenous bolus over a 15 minute period approximately every eight hours (+/- 1 hour) beginning within 24 hours of the cell infusion and continuing for up to 5 days (maximum 15 doses)
16222593|NCT01218867|Drug|Fludarabine|Fludarabine 25 mg/m(2)/day intravenous piggyback (IVPB) daily over 30 minutes for 5 days
16222594|NCT01218854|Device|Needle angle measurement|The tool for measuring the needle angles will be an FDA-approved EM tracking system. At no time will the needle enter tissue that it wouldn t have otherwise entered as neither system will be used to perform the biopsies at this time.
16222595|NCT01218841|Dietary Supplement|Fish oil lipid emulsion|0.2g of fat/kg of body weight/day for 3 days during 6 continuous hours in peripheral vein.
16222596|NCT01218841|Dietary Supplement|MCT/LCT|0.2g of fat/kg of body weight/day for 3 days during 6 continuous hours in peripheral vein.
16222597|NCT01218828|Other|LVEDP -Based hydration strategy|
16222598|NCT01218828|Other|Standard hydration|
16222599|NCT01218815|Procedure|IRA stenting in culprit lesion only|stenting
16222600|NCT01218815|Procedure|IRA stenting|Complete IRA revascularization
16222601|NCT01218802|Drug|Rosuvastatin 10 mg. daily for 96 weeks|Participants will take Rosuvastatin 10 mg. daily for 96 weeks.
16222602|NCT01218802|Drug|Placebo|participants will take a sugar pill daily for 96 weeks
16222603|NCT01218789|Drug|tasimelteon|20 mg tasimelteon capsules, PO daily for 1 year
16222604|NCT01218750|Procedure|Triple therapy for diffuse diabetic macular edema|Three port pars plana vitrectomy is performed by one surgeon (JR). Induction of PVD is initiated by active suction with the vitrectomy probe over the ONH and continued peripherally. Peeling of the epimacular tissue and ILM is performed by grasping the flap of the ILM with an eckhardts forceps. Trypan Blue is used to stain the ILM. Peripheral laser endophotocoagulation is performed in cases of avascular areas based on FA, active neovascularization, peripheral retinoschisis or retinal breaks. All eyes have a 1,25 mg/0,05 ml bevacizumab injection into vitreous cavity and SF6 gas tamponade at the end of the procedure. Even of absence of cataract formation, a combined procedure is performed because of exactly peripheral vitreous shaving and prevention of cataract formation.
16222605|NCT01218737|Drug|0.3% gatifloxacin and 1.0% prednisolone acetate association|"Each patient will receive two medication bottles (eye drops) in a blinded fashion: one with the association and another with placebo. The patient must instill 01 drop of each bottle in each operated eye, with a 5-minute interval between the instillations.
~This procedure should be performed 4 times a day (QID) during the wake hours, from Day 0 (surgery day) until Day 15."
16222606|NCT01218737|Drug|isolated 0.3% gatifloxacin and 1.0% prednisolone acetate|"Each patient will receive two medication bottles (eye drops) in a blinded fashion: one with the 0.3% gatifloxacin eye drops and another with 1.0% prednisolone acetate eye drops. The patient must instill 01 drop of each bottle in each operated eye, with a 5-minute interval between the instillations.
~This procedure should be performed 4 times a day (QID) during the wake hours, from Day 0 (surgery day) until Day 15."
16222607|NCT01218724|Drug|Losartan Potassium and Hydrochlorothiazide Tablets|
16222608|NCT01218711|Drug|Losartan Potassium and Hydrochlorothiazide Tablets|
16222609|NCT01218698|Drug|Losartan Potassium Tablets|
16222610|NCT01218685|Biological|Split inactivated A/California/7/2009 (H1N1) (NYMC X-179A) VIRUS|1 full dose of 15 micrograms, IM, for volunteers 9 years of age or older; children 6 months to 2 years of age, half of the dose,IM, with 21 days interval; children 3 years old up to 8 years old, 1 full dose, IM, twice, with 21 days interval.
16222656|NCT01218451|Biological|Combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine|0.5 mL dose, subcutaneous administration in right anterolateral thigh
16222611|NCT01218672|Device|Photoselective Vaporization of the Prostate|"GreenLight XPS laser console GreenLight XPS consists of a 532 nm laser console capable of achieving power outputs between 20W and 180W. Laser technology is used to vaporize tissue for debulking prostatic hyperplasia and improvement of lower urinary tract symptoms. The 532 nm wavelength is in the visible spectrum as green light and is strongly absorbed by oxyhemoglobin.
~GreenLight XPS will be used in conjunction with the MoXy™ fiber. The fiber features a side firing mechanism delivering up to180W of 532 nm light to vaporize and coagulate the prostate tissue. The fiber is guided to the treatment site by the continuous flow cystoscope, consisting of an inner and outer sheath set, 30ْ forward oblique telescope and visual obturator."
16222612|NCT01218672|Device|Transurethral Resection of the Prostate|Monopolar and bipolar loop TURP Systems The TURP procedure requires the use of a resectoscope, camera system and irrigation fluid. The system consists of a generator unit and a wire loop with an electrical current running through the loop used to cut prostate tissue and cauterize. Prostate tissue is cut away in small pieces and removed at the end of the procedure using irrigation. There are many manufacturers of TURP systems. Any monopolar and bipolar loop system that carry the CE mark may be used for the study.
16222613|NCT01218659|Drug|migalastat hydrochloride|150-mg capsule administered orally QOD
16222614|NCT01218659|Biological|agalsidase|Agalsidase via intravenous infusion as prescribed by the participant's treating physician and in accordance with the approved prescribing information
16222615|NCT01218646|Biological|Investigational Quadrivalent Inactivated Influenza Vaccine, No Preservative|0.5 mL, Intramuscular
16222616|NCT01218646|Biological|Investigational Trivalent Inactivated Influenza Vaccine, No Preservative|0.5 mL, Intramuscular
16222617|NCT01218646|Biological|Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative|0.5 mL, Intramuscular
16222618|NCT01218646|Biological|Fluzone®: 2010-2011 Trivalent Inactivated Influenza Vaccine, No Preservative|0.5 mL, Intramuscular
16222619|NCT01218633|Drug|saline infusion|saline infused at 30ml/hour
16222620|NCT01218633|Drug|GLP-1-9,36 infusion|infused @ 1.2pmol/kg/min
16222621|NCT01218633|Drug|Exendin-9,39 at low dose|infused at 30pmol/kg/min
16222622|NCT01218633|Drug|Exendin-9,39 at high dose|infused @ 300pmol/kg/min
16222623|NCT01218620|Drug|Gamma-Secretase Inhibitor RO4929097|Given PO
16222624|NCT01218620|Drug|Ketoconazole|Given PO
16222625|NCT01218620|Drug|Rifampin|Given PO
16222626|NCT01218620|Drug|Midazolam Hydrochloride|Given IV
16222627|NCT01218620|Drug|Omeprazole|Given PO
16222628|NCT01218620|Drug|Tolbutamide|Given PO
16222629|NCT01218620|Drug|Dextromethorphan Hydrobromide|Given PO
16222630|NCT01218620|Other|Pharmacological Study|Correlative studies
16222631|NCT01218620|Other|Laboratory Biomarker Analysis|Correlative studies
16222632|NCT01218607|Drug|Bosentan|Treatment will be initiated at a dose of 62.5 mg twice daily for 4 weeks and then increased to the maintenance dose of 125 mg twice daily for 12 weeks.
16222633|NCT01218607|Drug|Placebo|Placebo will be taken twice daily for 16 weeks
16222634|NCT01218594|Drug|Endostatin|7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks
16222635|NCT01218581|Drug|received oral letrozole (2.5 mg/day)and goserelin subcutaneosly (3.6 mg/month)|
16222636|NCT01218568|Drug|Rifaximin plus lactulose|Rifaximin 400 mg three times a day Lactulose 30-60 ml in two or three divided doses.
16222637|NCT01218568|Drug|Lactulose|Lactulose 30-60 ml in two or three divided doses.
16222638|NCT01218555|Drug|Lenalidomide|Lenalidomide (10mg, 15mg, 20mg or 25mg) once daily by mouth, every day of each 28-day cycle.
16222639|NCT01218555|Drug|Everolimus|5mg or 10mg of everolimus administered once daily by mouth on a once daily continuous dosing schedule for 28 days.
16222640|NCT01218542|Radiation|Volumetric modulated arc therapy|Using volumetric modulated arc therapy to give simultaneous infield boost to gross metastatic brain lesions during whole brain radiation therapy.
16222641|NCT01218529|Drug|Lapatinib|Co-administration of lapatinib 1250mg once daily during the WBRT period (2 weeks)and then monotherapy with lapatinib 1500mg once daily for 4 weeks.
16222642|NCT01218516|Biological|Farletuzumab|"Combination Therapy: Farletuzumab 7.5 mg/kg will be administered intravenously on Cycle 1, Week 1 and Cycle 1, Week 2 (loading dose). Beginning on Cycle 2, Week 1, farletuzumab (7.5 mg/kg) will be administered intravenously on Week 1 of all additional cycles.
~Monotherapy: Farletuzumab 7.5 mg/kg will be administered intravenously on Week 1 of every 3-week cycle until disease progression."
16222643|NCT01218516|Other|Placebo|"Combination Therapy: Placebo will be administered intravenously on Cycle 1, Week 1 and Cycle 1, Week 2 (loading dose). Beginning on Cycle 2, Week 1, placebo will be administered IV on Week 1 of all additional cycles.
~Monotherapy: Placebo will be administered intravenously on Week 1 of every 3-week cycle until disease progression."
16222644|NCT01218516|Drug|Carboplatin|Carboplatin will be administered intravenously to achieve area under the serum concentration-time curve of 5 to 6 mg/mL^min [AUC5-6].
16222645|NCT01218516|Drug|Paclitaxel|Paclitaxel 200 mg/m^2 will be administered intravenously.
16222646|NCT01218516|Drug|Pemetrexed|Pemetrexed 500 mg/m^2 will be administered intravenously.
16222647|NCT01218516|Drug|Cisplatin|Cisplatin 75 mg/m^2 will be administered intravenously.
16222648|NCT01218503|Behavioral|CHOICES - obese|Standard group behavioral weight loss treatment
16222649|NCT01218490|Procedure|ovarian cancer surgery|
16222650|NCT01218477|Drug|Dasatinib|Oral tablets, 100-140 mg once daily, depending on cohort (100 mg for those with chronic myeloid leukemia [CML]-chronic phase; 140 mg for those with CML-advanced phase)
16222651|NCT01218477|Drug|BMS-833923|Oral capsules, 50-200 mg, depending on cohort (100 mg for those with CML-chronic phase; 140 mg for those with CML-advanced phase)
16222652|NCT01218464|Drug|Conventional plus MSC treatment|Participants received conventional treatment and taken i.v., once per 4 week, at a dose of 0.5*10E6 MSC/kg body for 12 weeks.
16222653|NCT01218464|Drug|Conventional plus pacebo treatment|Participants received conventional treatment and taken i.v., once per 4 week, at 50 ml saline for 12 weeks.
16222654|NCT01218451|Biological|Meningococcal group C polysaccharide conjugate vaccine|0.5 mL dose, subcutaneous administration in right anterolateral thigh
16222655|NCT01218451|Biological|Pneumococcal 13-valent conjugate vaccine|0.5 mL dose, subcutaneous administration in right anterolateral thigh
16222657|NCT01218438|Biological|Immune Globulin Intravenous (Human), 10% Solution|Intravenous infusion with IGIV, 10%
16222658|NCT01218438|Drug|Immune Globulin Subcutaneous (Human), 20% Solution|Subcutaneous infusion with IGSC, 20%
16222659|NCT01218425|Drug|Methylphenidate 40 mg|Oral dose 40 mg
16222660|NCT01218425|Drug|Levodopa/carbidopa 125 mg|oral dose, 100 mg levodopa, 25 mg carbidopa in one capsule
16222661|NCT01218425|Drug|Domperidon 10 mg|Domperidon 10 mg
16222662|NCT01218412|Behavioral|Web-based Motivational Interviewing|Participants will engage in 4 sessions of web-based motivational interviewing over the course of 4 weeks.
16222663|NCT01218399|Drug|Symbicort|
16222664|NCT01218386|Drug|Estradiol valerate|"Experimental group: estradiol valerate (Progynova, 2x2mg per day, 2mg in the morning, 2mg in the evening), orally, during 6-10 consecutive days from day 25 of the cycle onwards.
~Both groups:start rFSH (Puregon®) at a dose of 150 IU GnRH antagonist (Orgalutran®) initiation on D6 of the stimulation."
16222665|NCT01218373|Device|HOMESWEETHOME Services|Monitoring and alarm handling services. eInclusion services. Domotic services. Daily scheduler. Navigation services. Cognitive training services. Non-technology based services.
16222666|NCT01218373|Device|No HOMESWEETHOME services installed|Normal care and healthcare without HOMESWEETHOME services.
16222667|NCT01218360|Drug|Physician standard-of-care|Participants will be treated according to their physician's routine practice and the respective Summary of Product Characteristics (SmPC).
16222668|NCT01218347|Drug|Rosuvastatin|20 mg once daily for 21 days
16222669|NCT01218334|Device|12 Lead Glove|Comparison of EKG's derived from the 12 Lead Glove vs. the Gold Standard EKG machine
16222670|NCT01218321|Biological|antiepileptic treatment|White blood cells from peripheral blood samples
16222671|NCT01218308|Biological|FluLaval® Quadrivalent|One intramuscular dose for primed subjects. Two intramuscular doses for unprimed subjects.
16222672|NCT01218308|Biological|Havrix™|Two intramuscular doses for primed subjects. Three intramuscular doses for unprimed subjects.
16222673|NCT01218295|Device|Spirotiger®|training session :10 minutes twice a day X 4 weeks
16222674|NCT01218282|Behavioral|Home exercise training|20-30 min/day for at least 4 days/week
16222675|NCT01218282|Behavioral|NO Exercise Training|No intervention
16222676|NCT01218269|Device|nitinol u-clip|The U-clip is comprised of nitinol, an alloy of nickel and titanium.
16222677|NCT01218256|Other|Physical exercise training|aerobic endurance training (cycle ergometer, 60-70% heart rate reserve) hypertrophy resistance training (2sets, 10-12 repetitions, 70% of the one-repetition maximum) endurance resistance training (2 sets, 25-30 repetitions, 40% of the one-repetition maximum)
16222678|NCT01218243|Device|needle|For the acupoint group,needle on bilateral BL33 60-80mm with a 45°angle. A feeling of soreness and distension will be felt when needling into the 3rd posterior sacral foramina(S3).Needle with a 100-125 mm long needle without lifting, thrusting or rotating.An electric stimulator is put on.G6805-2 electric stimulator (produced by Shanghai Huayi Medical Instrument Co.Ltd), Sparse-dense wave,20Hz. Stop turning up the current intensity when patients could not stand. 5 times for the first two weeks and 3 times for the last two weeks, 30 min/time.The non-point group take the place 2 cun far from BL33 on the outside horizontally as the non-point and the manipulation methods are the same with those of the point group.
16222679|NCT01218230|Drug|Intravitreal Pegaptanib|Intravitreal pegaptanib, 0.3 mg, every 6 weeks for 3 injections and then PRN.
16222680|NCT01218217|Drug|SQ109|SQ109 150 mg tablet
16222681|NCT01218217|Drug|Rifampicin|Rifampicin 150 mg capsules
16222682|NCT01218204|Drug|10mg atorvastatin|10mg
16222683|NCT01218204|Drug|80mg atorvastatin|80mg
16222684|NCT01218204|Drug|GSK1292263 Placebo|Placebo
16222685|NCT01218204|Drug|100mg GSK1292263|100mg
16222686|NCT01218204|Drug|300mg GSK1292263|300mg
16222687|NCT01218204|Drug|800mg GSK1292263|800mg
16222688|NCT01218204|Drug|10mg ezetimibe|10mg
16222689|NCT01218204|Other|Washout|No interventions - washout period
16222690|NCT01218178|Drug|Sodium bicarbonate plus NAC|154 mEq/L sodium bicarbonate (infusion rate of 3 ml/Kg for 1 hour followed by 1 ml/Kg for 6 hours) plus NAC (1200 mg bid for 48 hours)
16222691|NCT01218178|Drug|Saline hydration plus NAC|0.9% saline (1 ml/Kg for 12 hours) plus NAC (1200 mg bid for 48 hours)
16222692|NCT01218165|Dietary Supplement|Probiotic drink|This group receives a probiotic drink daily for 6 week.
16222693|NCT01218165|Other|Control Group|without intervention
16222694|NCT01218126|Drug|losmapimod|comparison of different dosages of drug 2.5 mg, 7.5 mg or 15 mg
16222695|NCT01218126|Drug|placebo|placebo comparison with active
16222696|NCT01218113|Biological|GSK Biologicals HIV Vaccine 732462|2 or 3 doses according to protocol schedule
16222697|NCT01218113|Drug|Placebo|1 or 3 doses according to protocol schedule
16222698|NCT01218100|Drug|nebivolol and lisinopril (free combination)|"nebivolol 5-mg and lisinopril 10-mg (nebivolol non-trade 5-mg tablet and overencapsulated lisinopril 10-mg tablet)/QD/oral administration/up to 12 weeks
~nebivolol 20-mg and lisinopril 40-mg (nebivolol non-trade 20-mg tablet and overencapsulated lisinopril 40-mg tablet)/QD/oral administration/up to 10 weeks
~nebivolol 5-mg and lisinopril 40-mg (nebivolol non-trade 5-mg tablet and overencapsulated lisinopril 40-mg tablet)/QD/oral administration/up to 6 weeks
~nebivolol 20-mg and lisinopril 10-mg (nebivolol non-trade 20-mg tablet and overencapsulated lisinopril 10-mg tablet/QD/oral administration/up to 6 weeks"
16222699|NCT01218100|Drug|nebivolol monotherapy|"nebivolol 5-mg (non-trade 5-mg tablet)/QD/oral administration/up to 12 weeks
~nebivolol 10-mg (non-trade 10-mg tablet/QD/oral administration/for 1-week down-titration period only)
~nebivolol 20-mg (non-trade 20-mg tablet)/QD/oral administration/up to 10 weeks"
16222700|NCT01218100|Drug|lisinopril monotherapy|lisinopril 10-mg (overencapsulated 10-mg tablet)/QD/oral administration/up to 12 weeks lisinopril 40-mg (overencapsulated 40-mg tablet)/QD/oral administration/up to 10 weeks
16222701|NCT01218100|Drug|placebo|Placebo tablet, oral administration/QD/oral administration/up to 12 weeks Placebo capsule, oral administration/QD/oral administration/up to 12 weeks
16222702|NCT01218087|Device|Cranial cup device and Moldable positioner|The cranial cup device was used 12/24 hours (alternating with the moldable positioner device) and was evaluated for feasibility, safety and efficacy for preventing head shape deformity in hospitalized infants
16222744|NCT01217827|Behavioral|Clinical Reminder|
16222703|NCT01218087|Device|Moldable positioner device|This moldable positioning device was used 24/24 hours as a comparison to the cranial cup device.
16222704|NCT01218074|Device|Aggregometry+Thromboelastography|Patients undergo standard thromboelastography and subsequent aggregometry to test effectiveness of residual antiaggregation drugs. Patients found to have altered value undergo optimization with desmopressin.
16222705|NCT01218074|Device|Thromboelastography Alone|Patients undergo standard of care Thromboelastography to evaluate overall coagulation performance.
16222706|NCT01218061|Other|Pre-diabetes screening|The timing of the study is :- Screening of high metabolic risk patients based on a clinical score : Finnish Diabetes Risk Score ≥ 15- if Diabetes Risk Score ≥ 15 or if history of blood glucose between 1.10 and 1.26 g/l (impaired fasting glucose): measuring fasting glycaemia + HbA1C + lipids profile + creatinemia + liver enzymes- if fasting blood glucose between 1.10 and 1.26 g/l (=V0):* OGTT (oral glucose tolerance test) to identify subjects with impaired glucose tolerance (optional)* establishment of a serum bank to identify biomarkers (serum, genomic, proteomic) - to plan for 10 years annual follow-up (V1 to V10) with blood sample (fasting glycemia + HbA1C + lipids profile + creatinemia + liver enzymes + serum bank (not after V5)) Making a total of 11 visits (V0-V10) with 6 blood samples.
16222707|NCT01218048|Drug|Cetuximab|Pre-Surgery: IV, 400 mg/m2 day 1 then 250 mg/m2 alone days 8 and 15; Post-surgery: IV, 250 mg/m2 weekly concurrent with RT
16222708|NCT01218048|Procedure|Surgery|Surgery for tumor
16222709|NCT01218048|Radiation|Post-surgical radiation|Radiation (2 Gy/d) to min of 60 Gy + max of 66 Gy post-surgery
16222710|NCT01218048|Drug|Cisplatin or carboplatin|Cisplatin 30 mg/m2 or carboplatin AUC 1.5-2/week weekly, Concurrent with radiotherapy
16222711|NCT01218035|Drug|zoledronic acid|The patients in the active-treatment group will receive a single 5 mg dose of zoledronic acid intravenously just prior to release from the hospital (about 5th day post-surgery) as an adjunct therapy. The control group will receive a placebo (saline) infusion. All infusions will be given 100 ml in volume and infused over a period of 15 minutes with a pre- and post-infusion flush with normal saline.
16222712|NCT01218022|Drug|Losartan Potassium Tablets|
16222713|NCT01218009|Drug|Placebo Spiromax|Placebo as a dry-powder inhaled orally using the Spiromax inhaler. During the 12-week double-blind period, participants take two (2) inhalations four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.
16222714|NCT01218009|Drug|Albuterol Spiromax|"Albuterol as a dry-powder inhaled orally using the Spiromax inhaler. Each inhalation delivers 90 micrograms (mcg). During the 12-week double-blind period, participants take two (2) inhalations four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total dose of 720 micrograms per day for those paricipants randomized to the Albuterol treatment arm.
~The double-blind period is followed by a 40-week open-label period in which all study participants will take Albuterol Spiromax 90 micrograms (mcg)/inhalation as needed (PRN)."
16222715|NCT01217996|Behavioral|Computerized working memory training program (intervention)|A computer-based training program will be completed in the home. This program requires approximately 30 minutes every weekday for five weeks. The program software guides the child through eight rotating exercises each day, with increasing difficulty based on the child's level of performance. Exercises train both visuospatial and verbal WM using child-friendly activities. A research team member will serve as a coach who monitors weekly progress online and offers support through weekly phone calls with the study participants and their caregivers). Intervention participants will also partake in neuroimaging exams before and after the intervention
16222716|NCT01217996|Behavioral|Computerized working memory training program (control)|Participants randomized to the control group will not complete any intervention during the intervention time period and will not partake in neuroimaging exams. They will complete an immediate and six month post follow-up cognitive assessment. Following completion of these assessments, they will be provided the opportunity to complete the computer-based training program off study.
16222717|NCT01217970|Drug|Ibudilast|Ibudilast oral 20mg BID for 7 days
16222718|NCT01217970|Drug|Ibudilast|Ibudilast oral 50mg BID for 7 days
16222719|NCT01217970|Drug|Ibudilast|Placebo oral BID 7 days
16222720|NCT01217957|Drug|Ixazomib|Ixazomib capsules
16222721|NCT01217957|Drug|Lenalidomide|Lenalidomide capsules
16222722|NCT01217957|Drug|Dexamethasone|Dexamethasone tablets
16222723|NCT01217944|Drug|Ranibizumab|0.5 mg ranibizumab intravitreal injection
16222724|NCT01217944|Drug|Verteporfin PDT|Verteporfin (6 mg/m2) intravenous infusion
16222725|NCT01217944|Drug|Sham Ranibizumab|Empty vial to mimic the intravitreal injection
16222726|NCT01217944|Drug|Sham verteporfin PDT|Sham vPDT intravenous infusion of dextrose 5% solution followed by light application (PDT).
16222730|NCT01217918|Drug|1 mg|1 mg or placebo a material sparing tablet per day for 10 days
16222731|NCT01217918|Drug|5 mg|5 mg or placebo as material sparing tablet per day for 10 days
16222732|NCT01217918|Drug|10 mg|10 mg or placebo as a material sparing tablet per day for 10 days
16222733|NCT01217905|Drug|AZD7687|Oral suspension
16222734|NCT01217892|Drug|dapagliflozin|2.5 mg tablet, taken orally, twice daily
16222735|NCT01217892|Drug|dapagliflozin|5 mg tablet taken orally, twice daily
16222736|NCT01217892|Drug|dapagliflozin|10 mg tablet taken orally, once daily
16222737|NCT01217892|Drug|metformin|>/= 1500 mg total daily dose, tablets taken orally, twice daily
16222738|NCT01217892|Drug|placebo|placebo
16222739|NCT01217879|Drug|Telmisartan (Kinzal/Pritor, BAY68-9291)|Patients treated with telmisartan tablets under the real-life setting. Dosing regimen customised to the needs of each participating patient according to the investigators assessment
16222740|NCT01217866|Procedure|Laparoscopic assisted vaginal hysterectomy|Surgical removal of uterus vaginally
16222741|NCT01217853|Device|SENSIMED Triggerfish|Contact lens-based device for continuous intraocular pressure monitoring
16222742|NCT01217840|Drug|Drisdol (Ergocalciferol) Vitamin D2|Ergocalciferol 150,000 IU every 12 weeks for total of 24 weeks.
16222743|NCT01217840|Drug|Placebo|Placebo pill - 3 pills every 12 weeks for total of 24 weeks
16222745|NCT01217814|Drug|Sarilumab|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous"
16222746|NCT01217814|Drug|Placebo|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous"
16222747|NCT01217814|Drug|Golimumab|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous"
16222748|NCT01217814|Drug|methotrexate (MTX)|"Pharmaceutical form: tablet or solution for injection
~Route of administration: Oral (tablet) or subcutaneous, intramuscular (solution)"
16222749|NCT01217814|Drug|Folic/folinic acid|"Pharmaceutical form: tablet
~Route of administration: oral Folic/folinic acid continued according to local standard."
16222750|NCT01217801|Drug|Ondansetron (ODFS)|Ondansetron Orally Dissolving Filmstrip Ondansetron (ODFS)
16222751|NCT01217801|Drug|Ondansetron (ODT)|Ondansetron Orally Disintegrating Tablet Ondanestron (ODT)
16222752|NCT01217788|Drug|PH94B intranasal spray|Comparison of PH94B single dose intranasal spray and Placebo single dose intranasal spray
16222753|NCT01217775|Drug|PH80|PH80 intranasal spray 800 nanograms
16222754|NCT01217775|Drug|Placebo intranasal spray|Placebo intranasal spray
16222755|NCT01217762|Device|IRay|Low voltage stereotactic radiotherapy system
16222756|NCT01217749|Drug|PCI-32765|420 mg PO daily
16222757|NCT01217749|Drug|ofatumumab|per package insert as an IV infusion
16222758|NCT01217736|Drug|aliskiren|single dose, tablet
16222759|NCT01217736|Drug|placebo|single dose, tablet
16222760|NCT01217736|Drug|VTP-27999|single dose, tablet
16222761|NCT01217723|Biological|Anti-Thymocyte Globulin (Rabbit)|Thymoglobulin 0.5 mg/kg on Day -2 prior to the Transplant, 2.5 mg/kg on Day -1, and 2.5 mg/kg on the day of transplant.
16222762|NCT01217723|Other|Patients will receive a standard preparative regimen (i.e. one that does not contain Thymoglobulin)|The standard preparative regimen can be myeloablative or reduced intensity.
16222763|NCT01217710|Behavioral|Activity monitor/smartphone health coaching|Initial health coaching at enrollment will involve the collaborative creation of an action plan with personally relevant, specific actions for increasing physical activity. The short term goals will be rated for self-efficacy and modified to maximize likelihood of success. Health coaches will discuss important mediators of physical activity (e.g., self-efficacy, enjoyment, social support, problem-solving). Weekly coaching calls will involve discussion of progress toward goals and problem-solving of barriers utilizing a motivational interviewing approach. Motivational messages will also be developed and sent daily to participants via the smartphone. These messages will indicate the percentage of steps related to their daily goal.
16222764|NCT01217697|Drug|Abiraterone Acetate|Abiraterone acetate, type=equal, unit=mg, number=250, form=tablet, route=oral use, 4 tablets once daily.
16222765|NCT01217697|Drug|Prednisone\Prednisolone|Participants will receive prednisone 5 mg twice daily as oral tablet OR prednisolone 5 mg (if prednisone is not available).
16222766|NCT01217671|Biological|Kamada AAT for inhalation|Alpha-1 Antitrypsin (AAT)
16222767|NCT01217671|Other|Placebo|Placebo
16222768|NCT01217658|Behavioral|The Happiest Baby on The Block|"Those receiving the intervention will be trained in the infant soothing techniques outlined in The Happiest Baby on the Block."
16222769|NCT01217658|Behavioral|AAP Infant Colic counseling|Those receiving the control group allocation will be counseled using the American Academy of Pediatrics material for Infant Colic.
16222770|NCT01217645|Radiation|150 mg [14C] AZD6765|
16222771|NCT01217632|Drug|FG-3019|FG-3019 at a dose of 15-45 mg/kg will be administered every 3 weeks by IV infusion in a total volume of at least 250 mL in normal saline.
16222772|NCT01217632|Drug|Placebo|Placebo will be administered every 3 weeks by intravenous (IV) infusion in a total volume of at least 250 mL in normal saline.
16222773|NCT01217632|Drug|Entecavir|
16222774|NCT01217619|Drug|erlotinib|erlotinib 150mg/d continuously for 56 days
16222775|NCT01217606|Drug|bimatoprost/brimonidine tartrate/timolol ophthalmic solution (Triple Combination Therapy)|One drop of Triple Combination Therapy administered to each eye, twice daily for up to 12 months.
16222776|NCT01217606|Drug|Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution|One drop of Fixed Combination 0.2% brimonidine tartrate/0.5% timolol ophthalmic solution administered to each eye, twice daily for up to 12 months.
16222777|NCT01217593|Procedure|ultrasound|Ultrasound guidance will be used for paravertebral space localization when performing paravertebral blocks on females 25-85 having unilateral mastectomy.
16222778|NCT01217593|Procedure|predetermined distance|The predetermined distance technique will be used for paravertebral space localization when performing paravertebral blocks on females 25-85 having unilateral mastectomy.
16222779|NCT01217580|Drug|0.5% ropivacaine|20ml each side of the hip of 0.5% ropivacaine into the transverse abdominis plane after patient is brought to the recovery area after elective cesarean delivery
16222780|NCT01217580|Drug|0.9% sodium chloride|20ml each side of the hip of 0.9% sodium chloride into the transverse abdominis plane after patient is brought to the recovery area after elective cesarean delivery
16222781|NCT01217567|Procedure|Staples left, subcuticular suture right|Closure of the skin after cesarean section with staples on the left side of the wound and subcuticular suture on the right side.
16222782|NCT01217567|Procedure|Subcuticular suture left side and staples right|Closure of the skin after cesarean section with staples on the right side of the wound and subcuticular suture on the left side.
16222783|NCT01217541|Other|Education and Supervision|Implementation of Scales in the care of patients with dementia in nursing home units with focus on person-centred care. Supervision of caregivers on a regular basis.
16222784|NCT01217541|Other|Control|A control group of nursing home units that do not get any form of active intervention
16222785|NCT01217528|Device|device settings for group A|VT zone: 350ms VF zone: 280ms
16222786|NCT01217528|Device|Device settings for group B|VT zone: 320ms VF zone: 250ms
16222787|NCT01217515|Drug|Diltiazem hydrochloride 4% cream|3 times daily
16222788|NCT01217515|Drug|Diltiazem hydrochloride 2% cream|3 times daily
16222789|NCT01217515|Other|Placebo|3 times daily
16222790|NCT01217502|Behavioral|Self management program|Professional caregivers will be trained in offering a self management program to aged persons with a dual sensory impairment. Duration of the program: 6 months
16222839|NCT01217151|Device|Hemodynamic monitoring|Hemodynamic monitoring based on the NICOM device
16222791|NCT01217502|Behavioral|self management program|Learning and practicing skills necessary to carry on an active and emotionally satisfying life in the face of the dual sensory impairment
16222792|NCT01217489|Procedure|Breast scan - Electrical Impedance Mammography|Scanning of the breast on a non-invasive device, using harmless minute electrical currents
16222793|NCT01217476|Drug|Trafermin 0.01% spray|For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
16222794|NCT01217463|Drug|Trafermin 0.01% spray|For ulcers with a maximum diameter (longest axis) of less or equal to 6 cm, the daily dose of trafermin 0.01% spray is 5 puffs (30 microgram) sprayed onto the wound surface. If the maximum diameter (longest axis) of the ulcer is >6 cm, the ulcer should be sprayed in two parts, i.e. 5 puffs (30 microgram) sprayed onto each half of the wound surface
16222795|NCT01217450|Drug|selumetinib|Given orally
16222796|NCT01217450|Biological|cetuximab|Given IV
16222797|NCT01217450|Other|laboratory biomarker analysis|Correlative studies
16222798|NCT01217450|Other|pharmacological study|Correlative studies
16222799|NCT01217437|Biological|Bevacizumab|Given IV
16222800|NCT01217437|Drug|Irinotecan Hydrochloride|Given IV
16222801|NCT01217437|Drug|Temozolomide|Given PO
16222802|NCT01217424|Other|questionnaire administration|
16222803|NCT01217424|Procedure|aromatherapy and essential oils|
16222804|NCT01217424|Procedure|management of therapy complications|
16222805|NCT01217424|Procedure|massage therapy|
16222806|NCT01217424|Procedure|psychosocial assessment and care|
16222807|NCT01217424|Procedure|reflexology procedure|
16222808|NCT01217411|Drug|Gamma-secretase/Notch signalling pathway inhibitor RO4929097|Given PO
16222809|NCT01217411|Radiation|Whole-brain radiation therapy (WBRT)|Undergo WBRT
16222810|NCT01217411|Radiation|Stereotactic radiosurgery (SRS)|Undergo SRS
16222811|NCT01217411|Procedure|Cognitive assessment|Ancillary studies
16222812|NCT01217411|Other|Laboratory biomarker analysis|Correlative studies
16222813|NCT01217398|Biological|bevacizumab|
16222814|NCT01217398|Drug|temozolomide|
16222815|NCT01217398|Genetic|polymorphism analysis|
16222816|NCT01217398|Other|pharmacogenomic studies|
16222817|NCT01217385|Procedure|DOSI|Bedside DOSI images of the tissue concentrations of deoxy-hemoglobin (ctHHb), oxy-hemoglobin (ctHbO2), water (ctH2O), lipid, tissue oxygen saturation (StO2), and TOI (ctHHb x tH2O/lipid) were acquired on both breasts up to four times during neoadjuvant chemotherapy (NAC) treatment.
16222818|NCT01217372|Dietary Supplement|Lemon supplementation|60 ml of lemon juice twice daily (an amount expected to provide 6 grams or 92 mEq of citric acid per day)
16222819|NCT01217359|Drug|Interferon Alfa-2b|Patients will receive a single dose of interferon followed by serial blood draws to assess cellular responses to interferon
16222820|NCT01217346|Other|no intervention is involved in this study|no intervention is involved in this study
16222821|NCT01217333|Behavioral|In-person CP|CP is a structured interview in which a lay health worker prompts a patient to articulate questions and concerns about decision issues in preparation for a treatment discussion with a provider. The Consultation Planner (CPer) then completes and prints out a word-processed template, paraphrasing and summarizing the patient's questions and concerns. The patient takes away the printed Consultation Plan to serve as a visual aid and agenda during the meeting with the doctor. CPers are trained to avoid providing medical advice or information. Arrangements will be made for participants who do not have transportation to the CRCMC.
16222822|NCT01217333|Behavioral|Tele-CP|Participants in the Tele-CP arm will receive CP by telephone. Arrangements will be made for participants who do not have access to a telephone.
16222823|NCT01217320|Dietary Supplement|creatine|5g/d throughout 12 weeks
16222824|NCT01217320|Dietary Supplement|placebo (dextrose)|5g/d throughout 12 weeks
16222825|NCT01217307|Drug|Metformin|Metformin 500mg twice daily during 4 months
16222826|NCT01217307|Drug|Placebo|Placebo twice daily during 4 months
16222827|NCT01217294|Procedure|ultrasound guided fascia iliaca block|Spinal anaesthesia with hyperbaric bupivacaine at a dose between 10 and 15mg as deemed appropriate by the anaesthetic doctor performing the spinal injection, no spinal morphine and ultrasound guided fascia iliaca plane block using 2mg/kg levobupivacaine diluted to a total of 40ml with sterile saline.
16222828|NCT01217294|Procedure|spinal morphine|Spinal anaesthesia with hyperbaric bupivacaine 10 - 15mg as deemed appropriate by the anaesthetists performing the spinal injection, and with the addition of intrathecal morphine 100 micrograms. Sham fascia iliaca plane injection with saline.
16222829|NCT01217281|Procedure|Full Mouth Non-Surgical Periodontal Therapy|Non-surgical Periodontal Therapy provided in two sessions, one for the right half and one for the left half of the dentition. Treatment sessions are provided within one week. No antibiotics or other adjunctive medications are to be used
16222830|NCT01217268|Behavioral|Training in person centered care by supervision using video-conference|The investigators will use video-conference for supervising and training of staff members in nursing homes
16222831|NCT01217229|Drug|PLX3397|Capsules administered once or twice daily, continuous dosing. Subjects will begin with 900 mg/day, but should safety data allow in our PLX108-01 study, subject may dose at 1200 mg/day.
16222832|NCT01217216|Behavioral|Group-based Intervention|compared effects of a group-based intervention on weight loss and physical activity.
16222833|NCT01217216|Behavioral|Telephone-based Intervention|compared telephone-based intervention to weight loss and physical activity.
16222834|NCT01217203|Drug|IPH2101 combined to lenalidomide|"Dose level 1 : 0.2 mg/kg IPH2101(with Lenalidomide 10 mg/day) Dose level 2 : 0.2 mg/kg IPH2101(with Lenalidomide 25 mg/day) Dose level 3 : 1 mg/kg IPH2101(with Lenalidomide 25 mg/day) Dose level 4 : 2 mg/kg IPH2101(with Lenalidomide 25 mg/day)
~Extension cohort: 6 patients at the Maximum Tolerated Dose (MTD)"
16222835|NCT01217190|Drug|Ondansetron (ODFS)|Test Article
16222836|NCT01217190|Drug|Zofran (ODT)|Comparator
16222837|NCT01217177|Drug|everolimus|
16222838|NCT01217164|Dietary Supplement|no intervention|received enteral diet with 4.5 g / kg / day of protein and 160cal/Kg/dia
16222841|NCT01217138|Device|Epinephrine autoinjector|We used 2 epinephrine autoinjector trainers and wrapped them by a gray sticky paper. Then,modified one of the trainers by changing gray safety cap to red with an atomizer paint and placing a yellow arrow pointing to the black injection tip.We provided three-step written and visual instruction sheet to use epinephrine autoinjector in Turkish same as given on the original trainer and changed that of the second trainer according to the modifications we made. Scoring system originally devised by Sicherer et al was used. Participants successively doing all steps were accepted to demonstrate autoinjector use correctly. Participants who tackled with black tip of autoinjector in order to eject needle after removing safety cap was regarded as unsuccessful since this may cause unintentional injection of epinephrine. All participants were scored and timed separately.
16222842|NCT01217125|Drug|Sirolimus|plasma levels between 4 and 8
16222843|NCT01217112|Drug|GWP42003|100 mg capsules, PO, BD, 91 days
16222844|NCT01217112|Drug|GWP42003|5 mg capsules, PO, BD, 91 days
16222845|NCT01217112|Drug|GWP42004|5 mg capsules, PO, BD, 91 days
16222846|NCT01217112|Drug|Placebo|0 mg capsules, QDS, PO, 91 days
16222847|NCT01217099|Drug|methylprednisolone|treatment patients were iv methylprednisolone pulse azithromycin for 5 days.
16222848|NCT01217099|Drug|azithromycin|control patients were iv azithromycin for 5 days.
16222849|NCT01217086|Drug|Infliximab|Infliximab 3mg/kg is going to be administered for both arm as a 2-hour infusion per dose.
16222850|NCT01217073|Drug|Omarigliptin|Omarigliptin 0.25, 1, 1.5, 10 or 25 mg oral capsule administered once weekly. For omarigliptin 3 mg, participants received two omarigliptin 1.5 mg capsules.
16222851|NCT01217073|Drug|Placebo to omarigliptin|Matching placebo to omarigliptin 0.25, 1, 1.5, 10 or 25 mg oral capsule administered once weekly. For matching placebo to omarigliptin 3 mg, participants received two matching placebo to omarigliptin 1.5 mg capsules.
16222852|NCT01217073|Drug|Pioglitazone|Pioglitazone 15 mg oral tablet or capsule administered once daily
16222853|NCT01217073|Drug|Metformin|Metformin 500 mg oral tablet administered once or twice daily
16222854|NCT01217073|Drug|Placebo to metformin|Matching placebo to metformin oral tablet administered once daily
16222855|NCT01217060|Drug|Docetaxel|20 mg/m2 given by vein (IV) over 1 hour once a week for up to 5 1/2 weeks.
16222856|NCT01217060|Drug|5-FU|300 mg/m2 given by vein, continuously for 96 hours a week for about 5 1/2 weeks.
16222857|NCT01217060|Radiation|Radiotherapy|50.4 Gy (1.8G/Fx/day) for about 5 1/2 weeks, Monday through Friday.
16222858|NCT01217060|Procedure|Esophagectomy|Surgery to remove part of esophagus and nearby lymph nodes, approximately 8 to 10 weeks after completing chemoradiation.
16222859|NCT01217060|Drug|Dexamethasone|10 mg IV 30 minutes prior to weekly Docetaxel.
16222860|NCT01217047|Device|FES Cycling|You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. Electrodes (pads that stick to the skin) will be placed on your skin on your legs and buttock. The pads will be connected to a stimulator box through a wire. We will then start the cycle motor and stimulate your leg and buttock muscles with electric current. This will cause your legs to cycle. You will do this for 1 hour.
16222861|NCT01217047|Device|Cycling without FES|You will be seated in your own wheelchair in front of the cycle. We will place your legs onto the cycle and secure them with straps. The cycle is configured to work without FES. We will then start the cycle motor. This will cause your legs to cycle. You will do this for 1 hour.
16222862|NCT01217047|Procedure|Lumbar puncture|The study includes 2 lumbar punctures: one at the beginning of the study and one at the end. During a lumbar puncture a small needle will be inserted into the lower back and a small amount of spinal fluid will be drained (about 1 tablespoon).
16222863|NCT01217047|Behavioral|Mood assessment|"If you do not already have an account, you will be signed up with Mood24/7 (http://www.mood247.com). This is a free service that texts your mobile phone daily asking you to rate your mood on a scale of 1 (low) through 10 (high). We will not monitor your entries during the study but only at the final visit when we will get a printout of the course of your mood during the study. After completion of the study we will assist you in removing us from your Mood24/7 account and we will no longer have access to your mood reports outside of the study period."
16222864|NCT01217034|Drug|TACE with sorafenib|Sorafenib will be administrated at a dose of 400mg o.d. before the first TACE. After 2days drug rest, TACE will be conducted. Sorafenib will be resumed at a dose of 400mg o.d. from 3 days after TACE(the resumption day can be postponed until 21 days after TACE). When tolerability is confirmed at 1 week after resumption, the dose of sorafenib will be increased to 400mg b.i.d. When tumor increases, TACE will be repeated.
16222865|NCT01217034|Procedure|TACE alone|TACE will be conducted at scheduled day. When tumor increases, TACE will be repeated.
16222866|NCT01217021|Drug|[18F] MNI-558|Subjects will be injected with 5mCi, not to exceed >10% of 5mCI, of [18F]MNI-558, followed by PET imaging.
16222867|NCT01217008|Biological|GRNOPC1|One injection of 2 million GRNOPC1 cells.
16222868|NCT01216995|Biological|Dose A|ADRC Dose A
16222869|NCT01216995|Biological|Placebo|Placebo Comparator
16222870|NCT01216982|Drug|Lovaza, omega-3 fatty acid ethyl ester|Three 1g capsules/day for three months; this corresponds to a total of 2520mg EPA+DHA/day
16222871|NCT01216982|Drug|Placebo, visually identical to Lovaza|Three 1g corn oil capsules/day for three months
16222872|NCT01216956|Drug|Extended-release nicotinic acid versus placebo|Voluntary men with mixed dyslipidemia and abdominal obesity will receive extended release nicotinic acid. The dose of niaspan will be up-titrated for 3 weeks starting at 500 mg/d in order to reach 2g/d at start of week 4 dose which will be continued until the end of week 8. After a wash-out period of 3 weeks, they will receive placebo for 8 weeks. According to their randomization arm, subjects will receive either in first place placebo followed by extended release nicotinic acid or the opposite.
16222873|NCT01216943|Drug|bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution|One drop of Triple Combination Therapy (bimatoprost/brimonidine tartrate/timolol fixed combination ophthalmic solution) administered to each eye, twice daily for 12 weeks.
16222874|NCT01216930|Other|Observation|Observation
16222875|NCT01216904|Drug|nicotine patch|7 mg patches to be worn for 16 hours per day
16222876|NCT01216904|Drug|placebo|placebo patch to be worn 16 hours per day
16222967|NCT01216241|Drug|Daptomycin|8 mg/kg once daily
16223127|NCT01214993|Drug|Iohexol Injection|Iohexol is an FDA approved radiologic contrast medium
16222877|NCT01216891|Behavioral|Multi-element, team-oriented treatment|Participants will receive treatment and services based on their needs coordinated by a small team that is led by a clinical coordinator. Services that are available to the participants include social skills training, medication treatment to address symptoms, education and employment advising, and substance use treatment.
16222878|NCT01216878|Drug|losartan potassium|100 mg tablet
16222879|NCT01216865|Biological|umbilical cord mesenchymal stem cells|5*10/7 per ischemic limb
16222880|NCT01216865|Drug|Standard Therapy|Any thing directed to improve blood perfusion in the limb example.Heparin,Antiplatelet agents etc
16222881|NCT01216852|Drug|Losartan Potassium|100 mg tablet
16222882|NCT01216839|Drug|Everolimus|Everolimus will be administered every day, initial dose 5 mg/m²/day, in 28 days cycle. Maximum dose: 10 mg/day. The cycles will be repeated till progression disease or untolerable toxicity.
16222883|NCT01216826|Drug|Everolimus|Everolimus will be administered every day, initial dose 5 mg/m²/dia, in 28 days cycles. Maximum dosis: 10 mg/day. The cycles will be repeated till progression disease or untolerable toxicity.
16222884|NCT01216813|Other|informational intervention|
16222885|NCT01216813|Procedure|assessment of therapy complications|
16222886|NCT01216813|Procedure|psychosocial assessment and care|
16222887|NCT01216800|Procedure|adjuvant therapy|
16222888|NCT01216800|Procedure|assessment of therapy complications|
16222889|NCT01216800|Procedure|quality-of-life assessment|
16222890|NCT01216800|Radiation|3-dimensional conformal radiation therapy|
16222891|NCT01216800|Radiation|intensity-modulated radiation therapy|
16222892|NCT01216787|Drug|gamma-secretase/Notch signalling pathway inhibitor RO4929097|
16222893|NCT01216787|Other|pharmacological study|
16222894|NCT01216787|Procedure|therapeutic conventional surgery|
16222895|NCT01216787|Other|laboratory biomarker analysis|Correlative studies
16222896|NCT01216774|Other|Strength training|"Leg extension exercise:
~Experimental: 60 repetitions at 20-25% of 1RM, 10-12 repetitions at 40% of 1RM Active Comparator: 10-12 repetitions at 80% of 1RM Placebo Comparator: 10-12 repetitions at 40% of 1RM"
16222897|NCT01216761|Drug|Iodine tincture|Iodine tincture (2% iodine and 2% sodium iodide diluted in 50% ethanol) packaged in a single 0.67 mL Sepp applicator (Enturia, Leewood KS)
16222898|NCT01216761|Drug|Chlorhexidine gluconate|2% chlorhexidine gluconate/70% isopropyl alcohol packaged in a single 1.5 ml Frepp applicators (Enturia, Leewood KS)
16222899|NCT01216761|Drug|Povidone iodine|10% povidone iodine aqueous solution packaged in a single 0.67 Sepp applicator (Enturia, Leewood KS)
16222900|NCT01216748|Other|quiet breathing|Subjects were instructed to breath normally at room air.
16222901|NCT01216748|Other|Hypocapnic Hyperventilation|hypocapnic hyperventilation, the subjects were instructed to breathe fast and deep until their end-tidal pCO2 fell to 30 mmHg, corresponding to a systemic pH increase of about 0.1 pH units.
16222902|NCT01216748|Other|Hypercapnic Hyperventilation|For hypercapnic hyperventilation, a modification of a previously described procedure (15). While monitoring SaO2 using pulse oximetry and end-tidal CO2 by mass-spectrometry on a breath by breath basis, CO2 was bled into the inspired air to achieve an end-tidal pCO2 of at least 55 mmHg
16222903|NCT01216748|Other|eucapnic hyperventilation|For eucapnic hyperventilation, the subjects were instructed to increase their ventilation to the highest level of ventilation recorded in the previous two hyperventilation maneuvers, while CO2 was bled into the inspired air to maintain end-tidal pCO2 at 40 mmHg.
16222904|NCT01216735|Drug|Fluticasone|220 ug twice a day for 3 weeks
16222905|NCT01216735|Drug|Placebo|Placebo for 3 weeks
16222906|NCT01216722|Other|Resistance Strengthening Exercise Program|Home exercise Program. 3-4 days a week. 30 minutes a session. 12 weeks
16222907|NCT01216709|Dietary Supplement|ferrous sulfate|6.3 mg iron from iron drops and 0.3 mg iron from infant formula with no added iron (0.5 mg iron/L) for 45 days
16222908|NCT01216709|Other|iron-fortified infant formula (12.4 mg iron/L)|6.6 mg iron from iron-fortified infant formula (12.4 mg iron/L) for 45 days
16222909|NCT01216709|Other|iron-fortified infant formula (2.3 mg iron/L)|1.2 mg iron from iron-fortified infant formula (2.3 mg iron/L) for 45 days
16222910|NCT01216696|Drug|ipilimumab|Eligible patients will receive 10 mg/kg ipilimumab every 3 weeks during a 10-week induction period, followed by a radiological assessment in week 12. Patients with clinical benefit will continue with an ipilimumab administration every 3 months starting at week 24 up to week 48 until the end of the study or until disease progression, toxicities requiring discontinuation , withdrawal of consent,pregnancy, death or lost to follow up whichever occurs first.
16222911|NCT01216683|Biological|rituximab|Given IV
16222912|NCT01216683|Drug|Bendamustin|Given IV
16222913|NCT01216683|Drug|bortezomib|Given IV
16222914|NCT01216683|Drug|lenalidomide|Given orally
16222915|NCT01216670|Behavioral|remote patient's management|scheduled remote CareLink data transmission
16222916|NCT01216657|Drug|Sunitinib|50 mg oral, daily, for 4 weeks, then 2 weeks without treatment, repeat at d43
16222917|NCT01216644|Drug|5-Fluorouracil|2600 mg/m²d1 i.v. every 2 weeks
16222918|NCT01216644|Drug|Leucovorin|200 mg/m², d1, i.v., every 2 weeks
16222919|NCT01216644|Drug|Oxaliplatin|85 mg/m², d1, i.v., every 2 weeks
16222920|NCT01216644|Drug|Docetaxel|50mg/m2, d1, i.v., every 2 weeks
16222921|NCT01216644|Drug|Epirubicin|50 mg/m2, d1, i.v., every 3 weeks
16222922|NCT01216644|Drug|Cisplatin|60 mg/m², d1, i.v., every 3 weeks
16222923|NCT01216644|Drug|5-fluorouracil|200 mg/m², d1-d21, i.v., every 3 weeks
16222924|NCT01216631|Drug|methylprednisolone|intra-articular injection of methylprednisolone (80mg given at baseline only)
16222925|NCT01216631|Drug|Infliximab|intra-articular injection of 100mg infliximab given at baseline only
16222926|NCT01216631|Drug|Infliximab|intravenous infliximab at a dose of 5mg/kg (as per patient weight) given at week 0, 2, 6 and 14
16222927|NCT01216618|Device|InsuPatch|the InsuPatchTM device includes a heating pad and electronics. The heating pad is attached to an existing insulin infusion set by a simple procedure.
16222928|NCT01216605|Drug|Syntocinon 24 IU|
16222929|NCT01216605|Drug|Placebo|
16223084|NCT01215292|Drug|Dutasteride|2.5 mg PO daily, Day 3-10
16223085|NCT01215292|Drug|Anastrozole|1 mg PO daily, Day 3-10
16222930|NCT01216592|Other|COPD treatment|Patients, will be asked to continue their previous medication (GOLD guidelines) during the study. No interventional change in COPD treatment will be performed during the study.
16222931|NCT01216579|Other|mannitol (an airway challenge agent)|
16222932|NCT01216566|Device|Occiflex Device|This device is a computerized robotic platform that allows continuous mobilization of the cervical spine in a three dimensional space. The patients undergoes biweekly 20 minute therapeutic session for 6 weeks
16222933|NCT01216553|Other|Oxygen Therapy|1 lt/min oxygen via nasal cannulae intermittently for 30 minuets 4 times daily for 7 days
16222934|NCT01216527|Procedure|Neo-adjuvant Chemoradiotherapy followed by Surgery|"Radiotherapy combined with concomitant chemotherapy:
~Radiotherapy Program:External radiation with a total dose of 40.0Gy is given in 20 fractions of 2.0Gy,5 fractions a week.
~neo-chemotherapy program: Vinorelbine 25mg/m2, IV (in the vein) on day 1 and day 8 of each 21 day cycle. Cisplatin 75mg/m2,IV DRIP on day 1 of each 21 day cycle;or Cisplatin 25mg/m2,IV DRIP on day 1 to day 4 of each 21 day cycle.
~Number of cycles:two
~surgery:Mckeown Modification Surgery and total two-field lymphadenectomy"
16222935|NCT01216527|Procedure|surgery|two field lymphadenectomy
16222936|NCT01216488|Drug|Xylocaine|40 ml or 25 ml of Xylocaine injection
16222937|NCT01216475|Procedure|Femtosecond LASIK|LASIK consists of two steps: the first step involves the formation of a corneal flap and the second one is when the excimer ablation is performed in the corneal stromal bed. Femtosecond lasers (FL) have been widely used in LASIK surgery to fashion the corneal flap. The laser will cut a lamellar followed by a vertical corneal incision. We are able to produce a vertical cut since the Femtosecond laser can deliver laser pulses of 1 micron diameter at a preselected depth in the cornea, which then expands to 2 to 3 microns with the formation of a cavitation bubble. These pulses create micro-photodisruption of the corneal tissue by the formation of an expanding bubble of carbon dioxide and water, which in turn cleaves the tissue and creates a plane of separation. The flap is then removed to expose the stroma and the refractive treatment is done by the excimer laser over the denuded stroma.
16222938|NCT01216475|Procedure|Small incision lenticule extraction (SMILE)|Patient's eye will be centered and docked with the curved interface cone before application of suction fixation. First, the posterior surface of the refractive lenticule (spiral in), then the lenticule border is created. The anterior surface of the refractive lenticule (spiral out) is then formed which extended beyond the posterior lenticule diameter by 0.5mm to form the anterior flap and is followed by a rim cut. After the suction is released, a Siebel spatula is inserted under the flap near the hinge before the flap is seperated and reflected. The edge of the refractive lenticule is separated from the stromal bed with a sinsky hook and the posterior border of the lenticule gently separated with the Siebel spatula and removed through small incision.
16222939|NCT01216449|Drug|Intravenous Citalopram|Single dose of 20mg parenteral citalopram diluted in 250mL of 0.9% sodium chloride solution, infused over 30 minutes
16222940|NCT01216449|Drug|Normal Saline|Single dose of 250mL of 0.9% sodium chloride solution, infused over 30 minutes
16222941|NCT01216436|Biological|Vaccination with RNA-transfected mature autologous DC|Dendritic cells (DC) will be administered at a dose of 20 million cells by intranodal injection under ultrasound guidance. Each subject will receive a total of six vaccinations at one week intervals
16222942|NCT01216410|Drug|Metoclopramide|Prophylactic Metoclopramide 10 mg given before spinal together with prophylactic phenylephrine infusion
16222943|NCT01216410|Drug|Phenylephrine infusion|Prophylactic phenylephrine infusion after spinal and placebo antiemetics
16222944|NCT01216410|Drug|Combination Group|Metoclopramide and ondansetron prophylaxis with phenylephrine infusion
16222945|NCT01216397|Drug|Linagliptin/Metformin (standard batch)|Fixed dose combination tablet
16222946|NCT01216397|Drug|Linagliptin/Metformin (side batch)|Fixed dose combination tablet
16222947|NCT01216384|Drug|BI 671800|In the SRD part subjects will receive a single dose and in the MRD part subjects will receive a total of 14 doses.
16222948|NCT01216384|Drug|placebo|Subjects will receive according to the dose group matching number of placebo tablets
16222949|NCT01216371|Drug|Sunitinib|one-year adjuvant Treatment with Sunitinib, schematic (4:2): 4 weeks (28) 50 mg(milligram) daily, 2 weeks (14) break
16222950|NCT01216371|Drug|Placebo|one-year Treatment, schematic (4:2): 4 weeks (28) 50 mg(milligram) daily, 2 weeks (14) break,
16222951|NCT01216345|Drug|Cetuximab + Gemcitabine + Oxaliplatin|Cetuximab 500mg/m2, iv every two weeks Gemcitabine 1000mg/m2, iv every two weeks Oxaliplatin 100mg/m2, iv every two weeks
16222952|NCT01216332|Drug|High-dose trivalent inactivated influenza vaccine|0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.
16222953|NCT01216332|Drug|Standard dose trivalent inactivated influenza vaccine|0.5 mL standard dose trivalent inactivated influenza vaccine
16222954|NCT01216319|Device|Nipple reconstruction|Biodesign® Nipple Reconstruction Cylinder
16222955|NCT01216306|Behavioral|Television reduction curriculum|Students are taught the television reduction curriculum during the school day (15-30 minutes/day) 3-5 days/week over 7 weeks. Parents are invited to attend brief after-school meetings every other week to discuss reducing their children's television viewing.
16222956|NCT01216293|Drug|Dexlansoprazole|Dexlansoprazole 60 mg, capsules, orally, once daily for up to 26 weeks.
16222957|NCT01216293|Drug|Esomeprazole|Esomeprazole 40 mg, capsules, orally, once daily for up to 26 weeks.
16222958|NCT01216293|Drug|Placebo|Placebo-matching capsules, orally, once daily for up to 26 weeks.
16222959|NCT01216280|Drug|placebo capsule|2 x 10 mg placebo capsules administered orally with water, b.i.d.
16222960|NCT01216280|Drug|10 mg Natura-alpha capsule and 10 mg placebo capsule|10 mg Natura-alpha capsule and 10 mg placebo capsule administered orally with water, b.i.d.
16222961|NCT01216280|Drug|2 x 10 mg Natura-alpha capsules|2 x 10mg Natura-alpha capsules administered orally with water, b.i.d.
16222962|NCT01216267|Drug|Lansoprazole|lansoprazole 30 mg HS x 7 days
16222963|NCT01216267|Drug|lansoprazole|lanzoprazole 30 mg HS for 7 days
16222964|NCT01216254|Device|classic v high-frequency electrocoagulation|During the BCT with SLND the investigators would use two types of electrocoagulation. The steps of the operation would remain the same in both arms, nevertheless the tool used would vary.
16222965|NCT01216241|Drug|Daptomycin|8 MG/KG IV
16222966|NCT01216241|Other|Saline Placebo|50 ml normal saline once daily
16222968|NCT01216202|Radiation|Preoperative radiotherapy|"Preoperative radiotherapy (RT) was administered as either short course (5Gy x5) or long-course (2Gy x25 or 1.8 Gy x25 with or without 3 fractions of boost to the primary tumor and radiologically malignant lymph nodes) treatment with or without concomitant or sequential chemotherapy. Oncological treatment was decided at a multidisciplinary team conference.
~Testicular doses (TDs) was calculated from planning CT-scans and reported as mean cumulative testicular dose. Relative TD was calculated based in the assumption that RT regimens for rectal cancer are bioequivalent and referred to as proportion of prescribed dose absorbed by the testes."
16222969|NCT01216189|Radiation|Preoperative radiotherapy|Preoperative radiotherapy (RT) was administered as either short course (5Gy x5) or long-course (2Gy x25 or 1.8 Gy x25 with or without 3 fractions of boost to the primary tumor and radiologically malignant lymph nodes) treatment with or without concomitant or sequential chemotherapy. Oncological treatment was decided at a multidisciplinary team conference.
16222970|NCT01216176|Drug|Anastrozole|
16222971|NCT01216176|Drug|AZD0530 (saracatinib)|
16222972|NCT01216176|Drug|Placebo|
16222973|NCT01216163|Drug|Novel Ibuprofen|Single-dose of novel ibuprofen (equal to 400 mg ibuprofen)
16222974|NCT01216163|Drug|Acetaminophen|Single-dose of acetaminophen (1000mg)
16222975|NCT01216163|Drug|Placebo|Single-dose of placebo
16222976|NCT01216137|Other|Exercise: Vestibular Rehabilitation|Balance and eye movement training
16222977|NCT01216137|Other|Exercise|Bicycle ergometry and stretching
16222978|NCT01216124|Drug|docetaxel oxaliplatin|"docetaxel 75mg/m2 D1 oxaliplatin 130mg/m2 D2
~1 cycle=21 days DO*6"
16222979|NCT01216111|Drug|Paclitaxel Cisplatin|"Paclitaxel 80 mg/m2 D1，8，15 Cisplatin AUC=2 D1，8，15
~1 cycle = 28days
~PC*6"
16222980|NCT01216111|Drug|fluorouracil epirubicin cyclophosphamide and docetaxel (FEC-T)|fluorouracil 500 mg/m2, epirubicin 100 mg/m2, and cyclophosphamide 500 mg/m2 intravenously on day 1 every 21 days for three cycles followed by docetaxel 100 mg/m2 intravenously
16222981|NCT01216098|Behavioral|Doula support|A doula is a paraprofessional who provides continuous emotional and physical support to women and their families during the intrapartum period.
16222982|NCT01216085|Drug|high-dose imatinib|Study patients will receive 400 mg twice daily oral administration in the morning and the evening.
16222983|NCT01216072|Drug|Fingolimod|0.5 mg/day oral capsule
16222984|NCT01216072|Drug|Standard MS DMTs|
16222985|NCT01216059|Procedure|Text message to cell phone|Subjects will receive a daily text message reminder about their treatment for atopic dermatitis during the 6 weeks of the study
16222986|NCT01216046|Drug|VX-809|capsule, taken once daily
16222987|NCT01216046|Drug|VX-770|tablet, taken once every 12 hours
16222988|NCT01216046|Drug|VX-809 placebo|capsule, taken once daily
16222989|NCT01216046|Drug|VX-770 placebo|tablet, taken once every 12 hours
16222990|NCT01216033|Drug|111-In-ABY-025|Intravenous injection of the agent
16222991|NCT01216020|Drug|cetuximab|"Cetuximab is given according to the standard mode of administration: loading dose : 400 mg/m2 one week before the start of radiotherapy (week -1), followed by a weekly dose of 250 mg/m2 during the weeks of the treatment with radiotherapy.
~Radiotherapy: Doses: Clinical sites of disease (T e N) : total dose of 70 Gy given with a fractional dose of 2 Gy/day; prophylactic nodal volume (N) : total dose of 50 Gy given with a fractional dose of 2 Gy/day ; Treatment technique: conformal 3D. Intensity modulated radiotherapy (IMRT), also with simultaneous boost (SIB), is allowed."
16222992|NCT01216020|Drug|cisplatin (associated to radiotherapy)|"CDDP dose: 40 mg/mq in a single weekly 1-hour infusion preceded by adequate hydration, diuretics e antiemetic premedication.
~Radiotherapy: Doses: Clinical sites of disease (T e N) : total dose of 70 Gy given with a fractional dose of 2 Gy/day; prophylactic nodal volume (N) : total dose of 50 Gy given with a fractional dose of 2 Gy/day ; Treatment technique: conformal 3D. Intensity modulated radiotherapy (IMRT), also with simultaneous boost (SIB), is allowed."
16222993|NCT01216007|Drug|propofol|In the TIVA group, IV access will be obtained as per BCCH routine, with caregiver present. 2% lidocaine 1 mg/kg will be administered via IV to prevent venous pain before induction of anaesthesia with propofol, as per BCCH standard. Induction of anaesthesia will be achieved with an IV bolus of propofol 5 mg/kg and remifentanil 2.5 mcg/kg. Anaesthesia will be maintained with an infusion of propofol 200-400 mcg/kg/min and remifentanil 0.1-0.2 mcg/kg/min. Once the subject is under general anaesthesia, the anaesthesiologist will place a second IV cannula, specifically for the collection of blood samples. This cannula will not be in the same limb as the propofol infusion.
16222994|NCT01216007|Drug|sevoflurane|In the volatile anaesthesia group, induction of anaesthesia will be achieved with inhalation of sevoflurane (5-8% in O2/air). Maintenance of anaesthesia will continue with a volatile agent of the anaesthesiologist's choice.
16222995|NCT01215981|Biological|Influenza vaccine|One dose of inactivated hemagglutinins of influenza A (H1N1, H3N2) and influenza B
16222996|NCT01215981|Biological|Influenza vaccine|Two doses of inactivated hemagglutinins of influenza A (H1N1, H3N2) and influenza B
16222997|NCT01215968|Biological|LY2189265|1.5 mg administered subcutaneously
16222998|NCT01215968|Drug|Placebo|Administered subcutaneously
16222999|NCT01215955|Drug|Insulin lispro|Administered subcutaneously, up to three times daily for 24 weeks
16223000|NCT01215955|Drug|Glargine|Administered subcutaneously, dosage determined by investigator once daily for 24 weeks
16223001|NCT01215942|Drug|LY2127399|Administered Subcutaneously
16223002|NCT01215929|Drug|Dextroamphetamine|Thirty treatment-seeking methamphetamine dependent volunteers will be admitted to a residential facility and be inducted onto d-amphetamine during week 1 of the study. 15 Participants then will be randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral d-amphetamine at a dose of 30 mg twice daily for 2 weeks.
16223003|NCT01215929|Drug|Placebo|Thirty treatment-seeking methamphetamine dependent volunteers will be admitted to a residential facility in this 4-week, double-blind, placebo-controlled, clinical trial and be inducted onto d-amphetamine during week 1 of the study. 15 Participants then will be randomized by severity of methamphetamine dependence, sex, amphetamine withdrawal questionnaire score and history of Attention Deficit Hyperactivity Disorder to receive oral placebo tablets twice daily for 2 week.
16223086|NCT01215292|Drug|Placebo ketoconazole|placebo to mimic ketoconazole
16223087|NCT01215279|Drug|AZD2423|100 mg oral treatment once daily for 28 days
16223004|NCT01215916|Drug|LY573636|"Individualized dose is dependent on a patient's height, weight, and gender and is adjusted to target a specific exposure range corrected for a patient's laboratory parameters. Intravenous dosing is completed once per cycle (cycle equals either 21 or 28 days).
~Patients may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
~Patients are pretreated with folic acid [350 micrograms (µg) to 1000 µg orally, daily], Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone [4 milligrams (mg) orally, twice daily or equivalent]."
16223005|NCT01215916|Drug|Pemetrexed|"375 to 500 milligrams per square meter (mg/m^2), intravenous dosing is completed once per cycle (cycle equals either 21 or 28 days).
~Patients may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criteria are met.
~Patients are pretreated with folic acid (350 µg to 1000 µg orally, daily), Vitamin B12 (1000 µg intramuscular injection every 9 weeks), and dexamethasone (4 mg orally, twice daily or equivalent)."
16223006|NCT01215903|Dietary Supplement|Fish gelatin and omega-3 polyunsaturated fatty acid|
16223007|NCT01215903|Dietary Supplement|Omega-3 polyunsaturated fatty acid|
16223008|NCT01215890|Drug|risedronate|
16223009|NCT01215890|Drug|placebo|
16223010|NCT01215877|Drug|Tesetaxel|"Tesetaxel capsules orally once every 21 days; duration of therapy not to exceed 12 months
~In Cycle 1, a dose of 27 mg/m2 will be administered. In subsequent cycles,
~the dose will be increased to 35 mg/m2 in Cycle 2 for subjects who did not have an ANC < 1,500/mm3, a platelet count < 100,000/mm3, or a Grade 3 (or higher grade) nonhematologic adverse event considered by the Investigator to be related to protocol therapy (excluding alopecia, nausea, and vomiting) in Cycle 1. The dose is not to exceed the dose of 35 mg/m2 in any cycle subsequent to Cycle 2.
~for all other subjects, the dose administered in Cycle 1 (27 mg/m2) will be administered in all subsequent cycles."
16223011|NCT01215864|Drug|TCD-717|"Patients will receive TCD-717 at the following dose levels:
~2, 4, 7, 10, 14, 19, 25, 31, 39, 49 or 61 mg/m^2"
16223012|NCT01215851|Drug|PA-824|200 mg tablet, once daily for 14 days
16223013|NCT01215851|Drug|Pyrazinamide|Dosed by Weight
16223014|NCT01215851|Drug|TMC207|TMC207 700 mg Day 1; 500mg Day 2; 400mg Days 3-14
16223015|NCT01215851|Drug|Rifafour|Rifafour e-275
16223016|NCT01215851|Drug|Moxifloxacin|moxifloxacin 400 mg
16223017|NCT01215799|Drug|Bafetinib|Bafetinib 240 mg bid
16223018|NCT01215786|Drug|AGN-207281 ophthalmic solutions (0.1% and 0.3%); AGN-207281 vehicle ophthalmic solution (placebo)|One drop of AGN-207281 ophthalmic solutions (0.1% on Days 1-7 and 0.3% on Days 8-14) instilled to both eyes in the morning followed by one drop of AGN-207281 vehicle ophthalmic solution (placebo) instilled to both eyes in the evening for 13 days.
16223019|NCT01215786|Drug|timolol ophthalmic solution 0.5%|One drop of timolol ophthalmic solution 0.5% instilled to both eyes, in the morning for 14 days, and in the evening for 13 days
16223020|NCT01215786|Drug|AGN-207281 vehicle ophthalmic solution (Placebo)|One drop of AGN-207281 vehicle ophthalmic solution instilled to both eyes, in the morning for 14 days and in the evening for 13 days.
16223021|NCT01215773|Drug|Placebo|Matching to HEA 200 mg tablet, oral administration
16223022|NCT01215773|Drug|BI 671800|High dose oral administration
16223023|NCT01215773|Drug|BI 671800|Medium dose oral administration
16223024|NCT01215760|Other|Training with a mirror|Early sensory reeducation group, started at the first week postoperatively, using specific guidelines using the mirror training and stimulation of the contralateral side. Initially, the stimulation will be unilateral and later bilateral, after the removal of the splint in 4 weeks.
16223025|NCT01215760|Other|No mirror therapy|The classical group iniciates after 16 weeks postoperatively and follow a standard home protocol for sensory reeducation without the mirror. It begins with recognition of textures and objects, and specific rehabilitation, if any associated injuries.
16223026|NCT01215747|Drug|KIACTA (eprodisate disodium)|Orally 1 to 3 capsules (Kiacta 400 mg) twice daily and adjusted as per the Creatine Clearance (CrCl) level increases or decreases.
16223027|NCT01215747|Drug|Placebo|Orally 1 to 3 capsules (placebo) twice daily and adjusted as per the Creatine Clearance (CrCl) level increases or decreases:
16223028|NCT01215734|Biological|High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV)|0.5 ml of HD-TIV on visit 1
16223029|NCT01215734|Biological|Standard Dose Trivalent Inactivated Flu Vaccine|Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1.
16223030|NCT01215721|Drug|Vesicare|5 mg daily
16223031|NCT01215708|Drug|Tamsulosin|tamsulosin 0,4mg every night for 30 consecutive days
16223032|NCT01215695|Device|aScope (Ambu Inc. 6740 Baymeadow Drive Glen Burnie, MD)|The aScope is a flexible, disposable plastic tracheoscope that incorporates a high-resolution video camera with an LED light at its flexible tip and has attached monitor.
16223033|NCT01215695|Device|Control|pre-formed stylet provided by the manufacturer of the GlideScope® video laryngoscope
16223034|NCT01215682|Dietary Supplement|vitamin D|2000 IU/day of vitamin D3 as a once-daily dose
16223035|NCT01215682|Dietary Supplement|placebo|sweetened water
16223036|NCT01215669|Biological|IDflu™: Split virion inactivated influenza vaccine|Single dose 0.1 mL, intradermal
16223037|NCT01215669|Biological|Vaxigrip®: Split virion inactivated influenza vaccine|Single dose 0.5 mL, intramuscular
16223038|NCT01215669|Biological|IDflu™: Split virion inactivated influenza vaccine|Single dose 0.1 mL, intradermal
16223039|NCT01215669|Biological|Vaxigrip®: Split virion inactivated influenza vaccine|Single dose 0.5 mL, intramuscular
16223040|NCT01215656|Dietary Supplement|Lactobacillus fermentum|
16223041|NCT01215656|Dietary Supplement|Follow on formula without probiotics|
16223042|NCT01215643|Drug|Alisporivir|ALV 200 mg soft gel capsules administered orally
16223043|NCT01215643|Drug|Peginterferon alfa-2a|PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
16223044|NCT01215643|Drug|Ribavirin|RBV 400 mg (2 x 200 mg tablets) administered orally twice daily (BID)
16223045|NCT01215630|Behavioral|Aerobic Interval Training|One interval training session
16223088|NCT01215279|Drug|Placebo to AZD2423|Oral treatment once daily for 28 days
16223089|NCT01215266|Drug|Sorafenib|Day 3-21 2x2 800 mg(milligram) daily
16223090|NCT01215266|Drug|Placebo|Day 3-21 2x2 800 mg(milligram) daily
16223046|NCT01215617|Behavioral|Aerobic Interval training|Treadmill walking or running - 3 times per week for 3 months. The interval training session consists of 10 minutes warm up and continues with 4 x 4 minutes high intensity intervals at 90-95% of maximal heart rate. Training intensity will be supervised through the use of Polar pulse monitors and the BORG scale of subjective perceived exhaustion.
16223047|NCT01215617|Behavioral|Control|Standard medical treatment
16223048|NCT01215591|Procedure|Gradual weaning from Nasal CPAP in preterm neonates|Nasal CPAP for gradual wean group it was cycled off for 3 hours alternating with 3 hours on for first 48 hours, if successful the cycle was extended to 6 hours off and 3 hours on for the next 48 hours. If the baby tolerated this regime the prongs were removed and CPAP was kept off.
16223049|NCT01215578|Drug|Sutent|sunitinib 37.5 mg/day (per os) for 6 months
16223050|NCT01215565|Drug|Sutent|Sunitinib 50mg/day (per os) for 6 cycles duration of one cycle = 6 weeks (4 weeks of treatment over 6 weeks)
16223051|NCT01215552|Drug|HT-0712|A range of single oral dose levels will be explored, utilizing 5mg and 25mg strength capsules
16223052|NCT01215539|Drug|panitumumab|Panitumumab will be administered by IV infusion on day 1 of each 3-week cycle prior to the administration of chemotherapy. The starting panitumumab dose is 9 mg/kg. Subjects with evidence of complete response, partial response or stable disease will continue to receive the combination of chemotherapy with panitumumab until disease progression, unacceptable toxicity or withdrawal of consent.
16223053|NCT01215513|Drug|Degarelix|
16223054|NCT01215500|Radiation|Hypofractionated RT|"RT to site of metastatic disease for three fractions separated by 3 to 8 days. Doses of radiation will increase as follows in order to determine the MTD in Gy:
~For all sites the dose levels are as follows:
~8 Gy/ fraction x 3 fractions = 24 Gy
~10 Gy/fraction x 3 fractions = 30 Gy
~12 Gy/fraction x 3 fractions = 36 Gy
~14 Gy/fraction x 3 fractions = 42 Gy
~16 Gy/fraction x 3 fractions = 48 Gy
~18 Gy/fraction x 3 fractions = 52 Gy
~20 Gy/fraction x 3 fractions = 60 Gy"
16223055|NCT01215487|Procedure|Stem Cell and Mutational Assay|Laboratory blood testing
16223056|NCT01215448|Dietary Supplement|Wheatgrass juice|110 CC daily od frozen wheatgrass juice in the intervention arm
16223057|NCT01215435|Drug|biphasic insulin aspart 30|Administered subcutaneously (under the skin) once daily, before breakfast. The trial has 3 treatment phases for both treatment arms
16223058|NCT01215435|Drug|biphasic insulin aspart 30|Administered subcutaneously (under the skin) once daily, before dinner. The trial has 3 treatment phases for both treatment arms
16223059|NCT01215422|Procedure|timed intubation|timed intubation
16223060|NCT01215409|Drug|Vardenafil (Levitra, BAY38-9456)|5 mg or 10 mg or 20 mg of Vardenafil, orally when necessary for 2 months
16223061|NCT01215396|Dietary Supplement|AminoVital Amino Acid formulation|Contains minerals, vitamin C, flavour and sweetener.
16223062|NCT01215396|Dietary Supplement|Amino Vital Amino Acid formulation|Contains minerals, vitamin C, flavour and sweetener and an amino acid mixture (2.4g of AA as: leucine, isoleucine, valine, arginine and glutamine).
16223063|NCT01215396|Dietary Supplement|Amino Vital Amino Acid formulation|Contains minerals, vitamin C, flavour and sweetener and a double dose of the amino acid mixture (4.8 g of AA as: leucine, isoleucine, valine, arginine and glutamine).
16223064|NCT01215370|Other|High-fat shake with Pea protein|Shake containing 95 gram of fat, additive 30 gram pea protein
16223065|NCT01215370|Other|High-fat shake with Pea protein hydrolysate|Shake containing 95 gram of fat, additive 30 gram gluten protein hydrolysate
16223066|NCT01215370|Other|High-fat shake - Control|Shake containing 95 gram of fat, no protein additive
16223067|NCT01215370|Other|High-fat shake with Gluten protein|Shake containing 95 gram of fat, additive 30 gram gluten protein.
16223068|NCT01215370|Other|High-fat shake with Gluten protein hydrolysate|Shake containing 95 gram of fat, additive 30 gram gluten gluten hydrolysate
16223069|NCT01215357|Drug|Ecopipam|50mg tablets
16223070|NCT01215344|Drug|VELCADE|1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle
16223071|NCT01215344|Drug|Lenalidomide|25 mg by mouth on days 1-4 of each cycle
16223072|NCT01215344|Drug|Dexamethasone|20 mg the day before and the day after receiving VELCADE
16223073|NCT01215344|Drug|DVT prophylaxis|At least one asprin 81 mg per day. Other option per physician's choice
16223074|NCT01215344|Drug|Bisphosphonates|Zoledronic acid by IB or pamidronate by IV can be used as per standard of care.
16223075|NCT01215344|Drug|Liposomal doxorubicin|30 mg/m2 on day 4 of each cycle
16223076|NCT01215344|Drug|Dexamethasone|40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4
16223077|NCT01215331|Drug|Insulin|Insulins most commonly used during pregnancy by our group are rapid acting insulins and long acting human insulins (long acting analogs are not authorized in pregnancy). An ultra-fast acting insulin will be started before a meal (1, 2 or 3 meals) at 4-6 IU (according to the weight) if the glycemic value 2 hours after this meal is ≥ 6.7 mmol/L in 50% of cases. It will be increased by 2 units every 2 days until obtaining the aimed objectives. Long acting insulin will be started at 4-6 units at bedtime if the glycemic value before breakfast is ≥ 5.3 mmol/L in 50% of cases, and it will be increased by 2 units every 2 days until reaching the objective. A combination of both insulins could be necessary (maximum of 4 injections per day).
16223078|NCT01215331|Drug|Metformin, glyburide and insulin|"Metformin (tablets of 500 mg) will be started at 250 mg/day x 1 day, and increased thereafter by 250 mg per day every 3 days until obtaining an adequate glycemic control. If metformin does not prove its effect at a dose of 750 mg, or if the side effects (mainly gastric) command to slow down or not to increase the posology, glyburide will be added.
~Glyburide (tablets of 5 mg) will be started at a dose of 2.5 mg and will be increased by 2.5 mg every 3 days until obtaining an adequate glycemic control. The maximal dose in the study will bw 10 mg. It corresponds to the half of the maximal dose recommended in Canada.
~Treatment failure is defined as glycemia above the Canadian Diabetes Association therapeutic objectives in spite of maximal doses or whether the doses can not be increased because of side effects. Insulin will be added to oral hypoglycemic agents."
16223079|NCT01215318|Device|modified vaginal tampon|modified vaginal tampons versus unmodified vaginal tampons, comparing the urinary contamination
16223080|NCT01215292|Drug|Acyline|300 mcg/kg on Day 1
16223081|NCT01215292|Drug|Testosterone gel|5 gm of 1% T Gel applied transdermally for 10 days
16223082|NCT01215292|Drug|ketoconazole 400|400 mg PO daily, Days 3-10
16223083|NCT01215292|Drug|Ketoconazole 800|800 mg PO daily, Day 3-10
16223091|NCT01215253|Drug|Ranolazine|At enrollment, patients will be randomized to ranolazine or placebo. In the active drug arm each patient will be started on a 500 mg twice a day dose for one week with subsequent increase to 1000 mg twice a day at beginning of second week.
16223092|NCT01215240|Device|Peritoneal dialysis|Prophylactic peritoneal dialysis
16223093|NCT01215227|Drug|Preladenant|Daily for 40 weeks: 2, 5, or 10 mg preladenant tablet each morning; 2, 5, or 10 mg preladenant tablet each evening (approximately 8 hours after the morning dose)
16223094|NCT01215227|Drug|Rasagiline|Daily for 40 weeks: 1 mg rasagiline capsule each morning
16223095|NCT01215227|Drug|Placebo to preladenant|Placebo to match preladenant given daily for 40 weeks: placebo tablet each morning; placebo tablet each evening (approximately 8 hours after the morning dose)
16223096|NCT01215227|Drug|Placebo to rasagiline|Placebo to match rasagiline given daily for 40 weeks: placebo capsule each morning
16223097|NCT01215214|Drug|midazolam|midazolam: 3mg iv
16223098|NCT01215201|Procedure|Scaling and Root Planing|Use periodontal hand instruments (curettes) to remove plaque, bacteria, and deposits on the root's surfaces.
16223099|NCT01215201|Procedure|Diode Laser + Scaling and Root Planing|First: Periodontal hand instruments (curettes) were used to remove plaque, bacteria, and deposits on the root's surfaces (within a periodontal pocket) Then: Biolase 940 nm Ezlase diode laser was used to sterilize a periodontal pocket. Power: 0.80 Watts Wavelength: 940 nm Energy level: 0.80 Joules/second Mode of beam delivery: continuous
16223100|NCT01215188|Biological|V114 Aluminum-adjuvanted|15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.2 mcg each), serotype 6B (4.4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.
16223101|NCT01215188|Biological|V114 Non-adjuvanted|15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2 mcg each), and serotype 6B (4 mcg) in each 0.5 mL dose.
16223102|NCT01215188|Biological|Prevnar 13®|13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each), serotype 6B (4.4 mcg each) and aluminum phosphate adjuvant (125 mcg) in each 0.5. mL dose.
16223103|NCT01215175|Biological|Prevnar™|13-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F (2.2 mcg each), serotype 6B (4.4 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.
16223104|NCT01215175|Biological|V114, Aluminum Adjuvanted|15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.0 mcg each), serotype 6B (4.0 mcg) and aluminum phosphate adjuvant (125 mcg) in each 0.5 mL dose.
16223105|NCT01215175|Biological|V114, Aluminum Nonadjuvanted|15-valent pneumococcal conjugate vaccine with serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F, 33F (2.0 mcg each), serotype 6B (4.0 mcg) in each 0.5 mL dose.
16223106|NCT01215162|Radiation|Intra-operative radiation to tumor bed|IOERT is given to the tumor bed. Applicator selection should allow treatment of the tumor bed plus 1-2 cm margin. The surgical incision may need to be enlarged slightly to allow the placement of the appropriate applicator. The use of more than 1 treatment field is discouraged. In order to encompass the entire tumor bed in 1 treatment field, it may be necessary to suture the mammary parenchyma loosely so that the lateral margins of the tumor bed are brought into apposition. Electron energy used for the treatment. If the tumor bed can be flattened and encompassed by an applicator, 6 MeV electron is recommended. Use of bolus material may be considered to increase the surface dose. If the mammary parenchyma has been brought into apposition by sutures, a higher electron energy may be necessary to allow adequate dose coverage to a depth of 1.0-2.0 cm into the tumor bed. The dose of IOERT is 1000 cGy, prescribed to the 90% isodose line.
16223107|NCT01215149|Biological|Ad35-ENV vaccine|Recombinant adenovirus serotype 35 vector vaccine 5x10^10 vp, delivered IM
16223108|NCT01215149|Biological|Ad26.ENVA.01 vaccine|Recombinant adenovirus serotype 26 vector vaccine, 5x10^10 vp delivered IM
16223109|NCT01215149|Biological|Placebo Control|Colorless 10mm Tris/HCl buffer
16223110|NCT01215136|Drug|Everolimus|10 mg PO daily (continuously, without scheduled treatment interruptions). The cycle length will last 28 days. Everolimus will be dispensed on Day 1 of each cycle by the study center personnel on an outpatient basis.
16223111|NCT01215136|Drug|Everolimus|10 mg PO daily (continuously, without scheduled treatment interruptions). The cycle length will last 28 days. Everolimus will be dispensed on Day 1 of each cycle by the study center personnel on an outpatient basis.
16223112|NCT01215136|Drug|Paclitaxel|Paclitaxel 80 mg/m2 IV as a 1 hour infusion on days 1, 8, and 15, of a 28-day cycle.
16223113|NCT01215123|Drug|Bevacizumab|Participants received bevacizumab according to routine clinical practice until disease progression, unacceptable toxicity or withdrawal, along with taxane-based chemotherapy or in combination with other chemotherapy as prescribed.
16223114|NCT01215110|Drug|TMC207|
16223115|NCT01215110|Drug|Rifafour e-275 mg|
16223116|NCT01215097|Drug|Linagliptin|once a day
16223117|NCT01215097|Drug|placebo|once a day
16223118|NCT01215084|Drug|BIIB041 (Fampridine-PR)|A single 10mg dose tablet by mouth of fampridine prolonged-release (PR) for all participants
16223119|NCT01215071|Procedure|limited lymphadenectomy|Field 5 (Group external iliac rigt) Field 7 (Group external iliac left) Field 9 (obturatorical Group right) Field 11 (obturatorical Group left) Field 13 (Group internal iliac right) Field 14 (Group internal iliac left)
16223120|NCT01215071|Procedure|extended lymphadenectomy|Field 1 (paracaval right) Field 2 (interaortocaval) Field 3 (paraaortal left) Field 4 (Group iliac artery right) Field 5 (Group external iliac rigt) Field 6 (Group iliac artery left) Field 7 (Group external iliac left) Field 8 (presacral) Field 9 (obturatorical Group right) Field 10 (deep obturatorical Group right) Field 11 (obturatorical Group left) Field 12 (deep obturatorical Group left) Field 13 (Group internal iliac right) Field 14 (Group internal iliac left)
16223121|NCT01215045|Device|AcrySof ReSTOR Aspheric +4|Implantation with the AcrySof ReSTOR Aspheric +4 Multifocal Intraocular Lens (IOL)
16223122|NCT01215032|Drug|Metformin|Taken orally twice daily each 28-day cycle, for 12 cycles
16223123|NCT01215019|Drug|Mannitol|20% Mannitol, 1-5 doses as needed to control ICP
16223124|NCT01215019|Drug|NaCl|3% sodium chloride injection, 1-5 doses, as needed to control ICP
16223125|NCT01214993|Drug|GSK1349572|GSK1349572 is an experimental drug in the integrase inhibitor class of drugs to treat human immunodeficiency virus (HIV)
16223126|NCT01214993|Drug|Placebo|Placebo is a tablet with no drug in it.
16223128|NCT01214993|Drug|Para-aminohippurate infusion|Para-aminohippurate is an agent to measure effective renal plasma flow.
16223129|NCT01214980|Device|MIST Therapy|Low-frequency, non-contact ultrasound therapy provided in conjunction with standard of care treatment on a daily basis for 5 days.
16223130|NCT01214980|Other|Standard of care|Standard of care provided per site-specific protocol
16223131|NCT01214967|Behavioral|Problem Solving Education|psycho-educational intervention
16223132|NCT01214954|Other|Supervised progressive resistance training|Resistance training 2 times/week initiated within the first week after total hip replacement. The training is supervised by physiotherapists and individually progressed.
16223133|NCT01214954|Other|Control group|Standard rehabilitation consisting of home-based exercises with 2 postoperative instructions by a physiotherapist.
16223134|NCT01214941|Drug|Placebo|The subjects will be given orally placebo twice a day for 5 days prior to the study.
16223135|NCT01214941|Drug|Ticlopidine|The subjects will be given orally ticlopidine 250mg twice a day for 5 days prior to the study.
16223136|NCT01214941|Drug|Ticlopidine and itraconazole|The subjects will be given orally ticlopidine 250mg twice a day and itraconazole 200mg as a single daily dose for 5 days prior to the study.
16223137|NCT01214928|Drug|Cholecalciferol|cholecalciferol 50,000 IU po once weekly for 12 weeks
16223138|NCT01214915|Drug|Anagrelide Hydrochloride|Subjects will be started at 1.0 mg per day and titrated as necessary.
16223139|NCT01214902|Device|Constraint induced movement therapy (CIMT)|soft mitten worn on the non hemiplegic hand
16223140|NCT01214902|Behavioral|play|play which encourages the use of the hemiplegic hand
16223141|NCT01214889|Biological|PENTAXIM™: DTacP IPV//PRP~T combined vaccine|0.5 mL, intramuscular
16223142|NCT01214889|Biological|TETRAXIM™: DTacP IPV combined vaccine and ActHIB™: PRP tetanus conjugate vaccine|0.5 mL of each vaccine; intramuscular
16223143|NCT01214863|Device|T3|Implantation of the AcrySof Toric Intraocular Lens (IOL) Model SN60T3
16223144|NCT01214863|Device|T4|Implantation of the AcrySof Toric Intraocular Lens (IOL) Model SN60T4
16223145|NCT01214863|Device|T5|Implantation of the AcrySof Toric Intraocular Lens (IOL) Model SN60T5
16223146|NCT01214850|Biological|Meningococcal B Recombinant + Outer Membrane Vesicle vaccine (rMenB+OMV NZ)|
16223147|NCT01214850|Biological|MenACWY-CRM conjugate vaccine|
16223148|NCT01214850|Biological|Japanese Encephalitis vaccine|
16223149|NCT01214837|Biological|MenACWY-CRM|This group received a 3-dose primary series at 2, 4, and 6 months of age and a toddler dose at 12 months of age. Approximately half of the subjects had serum collected at Month 3, and the remainder had serum collected at Month 4.
16223150|NCT01214837|Biological|MenACWY-CRM|This group received a 2-dose primary series at 2 and 4 months of age and a toddler dose at 12 months of age.
16223151|NCT01214837|Biological|Routine Vaccines|Each 0.5 mL dose of the pneumococcal 13-valent conjugate vaccine (diphtheria CRM197 protein) is formulated to contain approximately 2.2 μg of each of Streptococcus pneumoniae serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F saccharides.
16223152|NCT01214824|Device|FreeStyle Navigator Continuous Glucose Monitoring System|Six x 5 day wears of the continuous glucose monitoring device. Two of the 6 wears will be using a masked device (1 at the start and 1 at the end of the study).
16223153|NCT01214811|Device|Mepilex Border Ag|Mepilex Border Ag may be left in place for up to seven days, depending on the condition.
16223154|NCT01214785|Behavioral|Provision of household latrines|WaterAid and local NGO partners mobilize householders in target villages to construct and use latrines in accordance with the Government of India's Total Sanitation Campaign.
16223155|NCT01214772|Drug|heparin|5000 IU subcutaneously in the day of embryo transfer until 6 week after delivery
16223156|NCT01214759|Drug|Truvada|Tenofovir 200mg/emtricitabine 300mg once a day
16223157|NCT01214759|Drug|Raltegravir|Raltegravir 400mg twice a day
16223158|NCT01214746|Drug|Placebo|1 tablet Unikalk 1 time pr day for 5 days
16223159|NCT01214746|Drug|Atorvastatin|Zarator, 80 mg pr day for 5 days
16223160|NCT01214733|Drug|tocilizumab [RoActemra/Actemra]|8 mg/kg intravenously every 4 weeks in combination with allowed DMARDs
16223161|NCT01214720|Drug|bevacizumab [Avastin]|Intervenous repeating dose
16223162|NCT01214707|Other|Exercise|Exercise during EMU stay
16223163|NCT01214694|Behavioral|Internet-based Interacting Together Everyday: Recovery After Childhood TBI (I-InTERACT)|Families in I-InTERACT will view 10 web-sessions (like chapters) and participate in 27 family meetings over the course of 24 weeks focusing on increasing positive parenting skills, reducing parenting stress, and improving child behavior problems. Meetings will be conducted in their home using a computer hook-up with a trained therapist.
16223164|NCT01214694|Behavioral|Internet-based-Interacting Together Everyday, Recovery after Childhood TBI Express (I-InTERACT Express)|Families in I-InTERACT Express will view 10 web-sessions (like chapters) and participate in 14 family meetings over the course of 7 weeks focusing on increasing positive parenting skills, reducing parenting stress, and improving child behavior problems. Meetings will be conducted in their home using a computer hook-up with a trained therapist.
16223165|NCT01214694|Behavioral|Internet Resources Comparison (IRC)|Families in the IRC group will receive computers, high speed internet access, and links to brain injury information and resources. The resources are available for families to access as often as they choose.
16223166|NCT01214681|Dietary Supplement|Maltodextrin and Amioca starch|12g Maltodextrin and 23g Amioca starch daily in divided doses for 50 days. Provided as a powder to be added to food or drink.
16223167|NCT01214681|Dietary Supplement|Hi-maize 260|23g Hi-maize 260 and 12g Maltodextrin daily in divided doses for 50 days. Provided as a powder to be added to food or drink.
16223168|NCT01214681|Dietary Supplement|Polydextrose|12g polydextrose and 23g amioca starch daily in divided doses for 50 days. Provided as a powder to be added to food or drink.
16223169|NCT01214681|Dietary Supplement|Hi-maize 260 and polydextrose|12g polydextrose and 23g Hi-maize 260 daily in divided doses for 50 days. Provided as a powder to be added to food or drink.
16223205|NCT01214317|Procedure|plasmapheresis|3 courses of plasmapheresis are performed before mitoxantrone injection in first 3 months to investigate the efficacy of plasmapheresis in comparison with the other arm that are only treated with mitoxantrone
16223432|NCT01212705|Device|Adaptive servoventilation|Background expiratory positive airway pressure with some inspiratory pressure support when needed
16223170|NCT01214668|Drug|LY573636-sodium|"Individualized dose is dependent on participant's height, weight, gender and is adjusted to target a specific exposure range corrected for a participant's laboratory parameters. Intravenous dosing is done on Day 1 of a 28-day cycle.
~Participants may continue on study drug until disease progression, unacceptable toxicity, cumulative dose of 550 milligrams per square meter (mg/m²) of liposomal doxorubicin or doxorubicin is reached, or other withdrawal criterion is met."
16223171|NCT01214668|Drug|Liposomal Doxorubicin|"40 mg/m² on Day 1, given intravenously of each 28-day cycle
~Participants may continue on study drug until disease progression, unacceptable toxicity, cumulative dose of 550 mg/m² of liposomal doxorubicin or doxorubicin is reached, or other withdrawal criterion are met."
16223172|NCT01214655|Drug|LY2523355|Administered as a 1-hour IV infusion for at least 2 cycles. Cycle length is 21 days. Participants may continue on study drug until disease progression, unacceptable toxicity, or other withdrawal criterion is met.
16223173|NCT01214642|Drug|pegfilgrastim|Administered subcutaneously
16223174|NCT01214642|Drug|LY2523355|Administered intravenously
16223175|NCT01214629|Drug|LY2523355|Administered intravenously as a 1-hour infusion on Days 1, 2, 3 of each 21-day cycle for at least 2 cycles. Participants may continue on study drug until disease progression, unacceptable toxicity or other withdrawal criterion is met. Starting dose for LY2523355 alone arm is 0.125 milligrams per meter square per day (mg/m²/day).
16223176|NCT01214629|Drug|LY2523355|Administered intravenously as a 1-hour infusion on Days 1, 2, 3 of each 21-day cycle for at least 2 cycles. Participants may continue on study drug until disease progression, unacceptable toxicity or other withdrawal criterion is met. Starting dose for LY2523355 + pegfilgrastim is 4 mg/m²/day.
16223177|NCT01214629|Drug|pegfilgrastim|6 milligrams (mg) administered subcutaneously on Day 4 of each 21-day cycle for the 2 planned cycles and for any subsequent cycles of LY2523355 received.
16223178|NCT01214616|Drug|afatinib 20mg|patient to receive afatinib low dose po daily in combination with vinorelbine iv
16223179|NCT01214616|Drug|afatinib 40mg|patient to receive afatinib high dose po daily in combination with vinorelbine iv
16223180|NCT01214616|Drug|vinorelbine IV 25 or 20mg/m2|patient to receive standard dose vinorelbine once a week for four times per cycle
16223181|NCT01214603|Drug|LY2090314|Administered intravenously
16223182|NCT01214590|Device|VascuActive device|self treatment by the patient, for 4 weeks, 3 sessions per day, approximately 30 minutes per session
16223183|NCT01214577|Drug|PEP005 (ingenol mebutate) Gel|0.015%
16223184|NCT01214564|Drug|PEP005 (ingenol mebutate) Gel|0.05%
16223185|NCT01214512|Other|blood-sample based diagnostic assay|A blood sample will be used in a Western blot and ELISA assay to determine CD24 levels
16223186|NCT01214499|Procedure|Transmyocardial revascularization (TMR) with Holmium YAG laser|Transmyocardial revascularization (TMR) is a surgical procedure that uses a laser to create channels through the myocardial, so this laser stimulates local angiogenesis and provides blood in the ischemic area.
16223187|NCT01214499|Procedure|Transmyocardial revascularization (TMR) with Holmium YAG laser plus the patient's own stem cells extracted from bone marrow.|The system called PHOENIXTM consists of a laser probe with Holmium:YAG energy capable of creating transmural channels in the myocardium. Surrounding this fibre 3 needles with side holes are arranged so that the implantation of stem cells is done on the edges of the channel and not on the channel itself. This device is capable of distributing stem cells in those channels created by the laser, carrying out both procedures simultaneously.
16223188|NCT01214486|Drug|Raltegravir|Subjects should be on RAL 400mg twice daily at least 1 week. Subjects will be asked to come to the Specialty Clinic at two different points on the same day: at either 2, 4 or 6 hours after taking the drug, and at 10 or 12 hours after taking the drug. After completion of the first part of the study, subjects whose viral load is below the limit of detection (HIV RNA < 50 copies/mL) will be asked to switch to once a day RAL dosing (i.e. 800 mg once a day). Once the a subject has taken RAL once a day for at least three consecutive days, s/he will be asked to come to the Specialty Clinic at two different points in the same day to obtain blood by venous puncture. Blood will be obtained 2 or 4 hours after the dose and at 20-24 hours after the dose.
16223189|NCT01214473|Other|Synbiotics|Lactobacillus plantarum with fructo-oligosaccharide
16223190|NCT01214473|Other|Maltodextrin|Only maltodextrin as placebo
16223191|NCT01214447|Other|No intervention|Observational study - no intervention
16223192|NCT01214434|Device|Promiseb Topical Cream|topical non steroidal cream, twice daily
16223193|NCT01214434|Other|Bland emollient|Eucerin cream twice daily
16223195|NCT01214408|Drug|Buffered pantoprazole|Buffered pantoprazole 40 mg QD
16223196|NCT01214408|Drug|Buffered pantoprazole|Buffered pantoprazole 40 mg QD
16223197|NCT01214395|Drug|5% tea tree oil nasal ointment|daily for 5 days then weekly for 6 months
16223198|NCT01214382|Drug|Sertraline|Single dose sertraline 100 mg, tablet and solution
16223199|NCT01214369|Procedure|Type of Supplementary Injection|Patients will be selected from a group who were not anesthetized following 3.6 ml block injection. Half of the randomly selected patients will receive X-tip intraosseous injection and half will receive PDL injection as a supplementary for completing the anesthesia in selected hot mandibular molar teeth.
16223200|NCT01214356|Dietary Supplement|Vitamin D3|Patients receive vitamin D 400 IU/d with calcium carbonate (1000 mg) once per day for 15 months (3 month run in phase with 12 month follow up)
16223201|NCT01214356|Dietary Supplement|Vitamin D3|Patients receive vitamin D 4000 IU/d with calcium carbonate (1000 mg) once per day for 15 months (3 month run in phase with 12 month follow up)
16223202|NCT01214343|Drug|Sorafenib with Low-dose FP|Sorafenib will be administered orally at a dose of 400 mg bid for 28 days in a cycle. Cisplatin at the dose of 20 mg/m2 will be administered at day 1 and day8, and fluorouracil at the dose of 330 mg/m2 will be administered continuously at day 1-day 5, and day8-day12 via the implanted catheter system. A cycle is defined as 28 days.
16223203|NCT01214343|Drug|Sorafenib|Sorafenib will be administered orally at a dose of 400 mg bid for 28 days in each cycle.A cycle is defined as 28 days.
16223204|NCT01214330|Device|Patient-Collected Cervical Pap Smear|Patient-Collected Cervical Papanicolaou Smear
16223206|NCT01214304|Other|Essential Lavender Oil|Aromatherapy with essential lavender oil will be initiated 5 minutes prior to the procedure and continued until the conclusion of the procedure (patient dressed and ready to leave the room). The essential lavender oil and will be administered by fan diffuser.
16223207|NCT01214304|Other|Lavender Scent|Aromatherapy with a fake lavender scent (placebo) will be initiated 5 minutes prior to the procedure and continued until the conclusion of the procedure (patient dressed and ready to leave the room). The fake lavender scent will be administered by fan diffuser.
16223208|NCT01214291|Drug|Toremifene|Toremifene 80mg daily
16223209|NCT01214278|Drug|rTG|EPA+DHA as re-esterified triglycerides (rTGs) from fish-oil; uncoated capsules (4 per day); 2016 mg n3 fatty acids daily (1008 mg EPA and 672 mg DHA)
16223210|NCT01214278|Drug|GArTG|EPA+DHA as rTGs from fish-oil in gastric acid resistant (coated) capsules (GArTG); 4 capsules per day; 2016 mg n-3 fatty acids (1008 mg EPA and 672 mg DHA)
16223211|NCT01214278|Drug|EE|EPA+DHA as ethylesters (EE) from fish-oil uncoated capsules (4 per day); 2016 mg n-3 fatty acids (1008 mg EPA and 672 mg DHA)
16223212|NCT01214278|Drug|KPL|DHA+EPA as phospholipids from krill-oil, uncoated capsules (KPL); 7 capsules per day; 2100 mg n-3 fatty acids (1050 mg EPA and 630 mg DHA)
16223213|NCT01214265|Device|EMKinetics non-invasive Magnetic neurostimulator|Patients will be treated with 12 weekly sessions of magnetic stimulation of the posterior tibial nerve at 20 hz using the EMKinetics non-invasive Magnetic neurostimulator.
16223214|NCT01214252|Device|Permacol Surgical Implant|Permacol Surgical Implant
16223215|NCT01214239|Drug|Placebo|once a day
16223216|NCT01214239|Drug|Linagliptin|once a day
16223217|NCT01214226|Drug|Pentoxifylline|400 mg prolonged-released tablets 3 time per day for 1 month.
16223218|NCT01214226|Drug|placebo|prolonged-release tablets 3 time per day for 1 month
16223219|NCT01214200|Device|Bilevel positive airway pressure (BiPAP)|This is a single arm interventional study. Hypercapnic COPD participants that meet eligibility criteria will receive high intensity non-invasive positive pressure ventilation(HINPPV). Participants will receive HINPPV via bilevel positive airway pressure (BiPAP) via a Synchrony ventilator if they require an inspiratory positive airway pressure (IPAP) less than or equal to 30 cmH2O; or the Trilogy ventilator if they require an IPAP greater than 30 cmH2O.
16223220|NCT01214187|Drug|inhaled carbon monoxide|The intervention will be inhaled CO at 100-200 ppm administered two times weekly for two hours per dose to complete 12 weeks of treatment.
16223221|NCT01214187|Other|Oxygen|Room air oxygen concentrations will be administered as placebo
16223222|NCT01214174|Drug|IBI-10090|
16223223|NCT01214161|Drug|2% lidocaine gel|"Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control group with an inert gel similar in appearance, color and consistency to the lidocaine gel.
~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
16223224|NCT01214161|Other|placebo|"Participants, after informed consent, will be randomized in a 1:1 ratio to the inert gel group or the intervention group. In the intervention group, after tenaculum placement, a Q-tip soaked in approximately 1mL of 2% lidocaine gel will be placed in the cervix up to the level of the internal cervical os. The Q-tip will be held there for 1 minute and then be removed. We will repeat the same procedure in the control/placebo group with an inert gel similar in appearance, color and consistency to the lidocaine gel.
~Both the patient and the provider will be blinded to which gel was received. The research assistant will place the gel from its labeled tube into the unlabeled sterile tube in another room."
16223225|NCT01214148|Device|ORSIRO - Drug Eluting Coronary Stent|The coronary stent is delivered to the intended implantation location by means of the fast-exchange delivery system and then expanded to its final diameter by dilating the balloon. It remains in the vessel as a permanent implant.
16223226|NCT01214122|Drug|AZD9668|60 mg orally twice daily for 11 days
16223227|NCT01214122|Drug|Warfarin|10 x 2.5 (25) mg orally once daily on day 1 and on day 14
16223228|NCT01214109|Drug|pramipexole extended release|0.375mg once per day for 5 days (cross-over), 0.75mg once per day for 5 days (up-titration), 1.5mg once per day for 5 days (cross-over)
16223229|NCT01214109|Drug|pramipexole extended release|0.375mg once per day for 5 days (cross-over), 0.75mg once per day for 5 days (up-titration), 1.5mg once per day for 5 days (cross-over)
16223230|NCT01214109|Drug|pramipexole immediate release|0.125mg three times a day for 5 days (crossover), 0.5mg three times a day for 5 days (cross over)
16223231|NCT01214109|Drug|pramipexole immediate release|0.125mg three times a day for 5 days (crossover), 0.5mg three times a day for 5 days (cross over)
16223232|NCT01214096|Drug|rhNRG-1|Subcutaneous Administration:0.6ug/kg/day for 10days
16223233|NCT01214096|Drug|rhNRG-1|Subcutaneous Administration 1.2ug/kg/day for 10 days
16223234|NCT01214096|Drug|rhNRG-1|Vein infusion:0.6ug/kg/day for 10 days
16223235|NCT01214096|Drug|placebo|Subcutaneous Administration:0.6 or 1.2ug/kg/day for 10days
16223236|NCT01214083|Drug|N-acetylcysteine + high-dose naltrexone (150 mg)|All subjects will be evaluated weekly for 12 weeks.
16223237|NCT01214083|Drug|High-dose naltrexone (150 mg) alone|All subjects will be evaluated weekly for 12 weeks.
16223238|NCT01214083|Drug|Low-dose naltrexone (50 mg) alone|All subjects will be evaluated weekly for 12 weeks.
16223239|NCT01214070|Other|Vision Restoration Therapy|Therapy that enhances the neuronal plasticity of the visual system
16223240|NCT01214070|Behavioral|NVT Eye Scanning Therapy|Therapy that trains eye and head scanning into the blind hemianoptic visual field
16223241|NCT01214070|Behavioral|Eccentric Viewing Training|Therapy that trains the person to compensate for visual field loss by learning to move the visual field loss to the position that is least likely to impact the current visual task
16223242|NCT01214070|Behavioral|Sham|Therapy that encourages subjects to do daily visual tasks at home while having no training or intended intervention benefit
16223426|NCT01212731|Radiation|Photon treatment plans|10 of the 30 subjects on Cohort 1 will receive photon treatment plans.
16223497|NCT01211977|Drug|XOMA 052|
16223243|NCT01214057|Drug|Propofol and Remifentanyl|Anesthesia will be induced with lidocaine 0.5 mg kg, propofol infusion at 250 mcg/kg/min (to reduce visual bias of propofol infusion) and total volume infused will be adjusted for an induction dose of 2-3 mg/kg before bolus of muscle relaxant, rocuronium 0.5 mg kg in both SR and PR groups. Remifentanil infusion will be started at a rate of 0.4 mcg/kg/min 1-2 minutes before the propofol infusion and a 100 ml 0.9% normal saline bag will be used to blind surgeons in the sevoflurane group. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the propofol concentration within their range (100-150 mg ml for propofol) according to the anaesthesiologist's judgement and by surgeon request. If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.
16223244|NCT01214057|Drug|Sevoflurane and Remifentanyl|Sevoflurane 1-3% will be administered in group SR, and the infusion of propofol will be stopped. After intubation remifentanil infusion will be changed to 0.2 mcg/kg/min. The target mean arterial blood pressure (MAP) will be maintained at 70-80 mm Hg by adjusting the sevoflurane concentration within their range (between 1-3 vol% for sevoflurane) according to the anaesthesiologist's judgement and by surgeon request.If this failed, the remifentanil rate will be adjusted by 0.05 mg kg min.In order to limit the amount of fluids remifentanil wil be diluted at a concentration of 4 mg in 100 ml.
16223245|NCT01214044|Drug|placebo/escitalopram|Subjects will first complete a one week, single-blind placebo lead in phase. Subjects will then receive escitalopram for 8 weeks. Subjects will receive 10 mg/day for the first 2 weeks of active treatment, and then 20 mg/day for the remaining 6 weeks of treatment. Medication will be dispensed on a weekly basis.
16223246|NCT01214031|Device|Confocal laser endomicroscopy (CLE)|Confocal laser endomicroscopy (CLE) is another novel imaging tool for enabling histopathologic diagnosis in vivo during endoscopy. Specially designed confocal endoscopes have the confocal laser microscope integrated to the distal tip of the conventional endoscope. This provide images at a cellular level that have been shown to have a high sensitivity, specificity and accuracy
16223247|NCT01214018|Other|Questionnaires and interview|Questionnaires and interview
16223248|NCT01214005|Behavioral|smoking abstinence|3 days of biologically-confirmed smoking abstinence
16223249|NCT01213992|Drug|Iron isomaltoside 1000|Single dose of 500 mg administered as a bolus undiluted over 2 min.
16223250|NCT01213992|Drug|Iron isomaltoside 1000|Single dose of 1000 mg infused over 15 min. The infusion is diluted in 100mL 0,9% sodium chloride
16223251|NCT01213979|Drug|500 mg iron isomaltoside 1000|500 mg iron isomaltoside 1000 given as a bolus injection over 2 minutes
16223252|NCT01213979|Drug|1000 mg iron isomaltoside 1000|1000 mg iron isomaltoside 1000 given as a infusion over 15 minutes
16223253|NCT01213966|Drug|OZ439|po, single dose
16223254|NCT01213940|Behavioral|pre-bariatric weight loss program|standard 6 month physician directed pre-bariatric weight loss program
16223255|NCT01213940|Procedure|bariatric surgery|bariatric surgery for weight loss
16223256|NCT01213914|Device|An FDA approved continuous renal replacement device|"70ml/kg/hr for treatment group for 48 hours with the following requirements:
~double lumen dialysis catheter should be placed in the internal jugular or femoral vein
~Anticoagulation will be determined by prescribing physician
~Use of 1.4 m2 or larger biocompatible synthetic hollow-fiber dialysis membrane that is changed every 24 hours
~Blood flow rate will be set to ensure a filtration fraction of no more than 25%
~Monitoring for electrolytes (specifically K+, Mg, Ca, and phos) during HVHF must be performed at least every 6 hours
~Replacement fluids will be bicarbonate-buffered with appropriate adjustments when citrate-anticoagulation is utilized
~All antibiotics will be dose adjusted for renal replacement therapy"
16223257|NCT01213914|Other|Control Group|Both groups will receive 'contemporary' care via consideration of the Burn-specific Sepsis Bundle adapted from the most recent Surviving Sepsis Campaign (SSC) (1) recommendations and specifically modified to our patient population
16223258|NCT01213901|Procedure|Lispro insulin|Each patient will receive 2 insulin injections in the abdomen: Once using a pinch method and once using a spread method.
16223259|NCT01213888|Drug|Trientine Hydrochloride|All participating subjects will all receive PRP (pan-retinal photocoagulation) according to present standards of care; however, subjects randomized the intervention group (trientine hydrochloride) will be on a 10-day course of oral Trientine at 1500mg administered for 7-days prior to and 3 days after the PRP sessions.
16223260|NCT01213888|Drug|Oral placebo capsules|All participating subjects will all receive PRP (pan-retinal photocoagulation) according to present standards of care; however, subjects randomized the placebo group will be on a 10-day course of oral placebo capsules at 1500mg administered for 7-days prior to and 3 days after the PRP sessions
16223261|NCT01213875|Behavioral|Home based education|There will provided education about what is heart failure, its causes, how to recognize signs and symptoms, monitoring of weight and blood pressure, the importance of compliance to treatment. Patients will be instructed about the medications; a guide to rest and exercise, sexual activity, vaccines, travel and diet will be provided. The involvement of the family will be encouraged; the contact with the team should be done when: patient observes an increase of 1 or 2 kg of weight in 2-3 days, worsening of dyspnea on effort, edema in legs / abdomen, worsening of cough, persistent vomiting, syncope,sputum with blood, fever, persistent tachycardia. In phone calls made between home visits, the compliance to treatment will be evaluated and reinforced.
16223262|NCT01213862|Behavioral|Home Based Education|There will provided education about what is heart failure, its causes, how to recognize signs and symptoms, monitoring of weight and blood pressure, the importance of compliance to treatment. Patients will be instructed about the medications; a guide to rest and exercise, sexual activity, vaccines, travel and diet will be provided. The involvement of the family will be encouraged; the contact with the team should be done when: patient observes an increase of 1 or 2 kg of weight in 2-3 days, worsening of dyspnea on effort, edema in legs / abdomen, worsening of cough, persistent vomiting, syncope, sputum with blood, fever, persistent tachycardia. In phone calls made between home visits, the compliance to treatment will be evaluated and reinforced.
16223263|NCT01213849|Drug|Fluticasone furoate 50 mcg (4 inhalations)|4 inhalations of 50 mcg strength
16223264|NCT01213849|Drug|Fluticasone furoate 100 mcg (4 inhalations)|4 inhalations of 100 mcg strength
16223265|NCT01213849|Drug|Fluticasone furoate 200 mcg (4 inhalations)|4 inhalations of 200 mcg strength
16223266|NCT01213849|Drug|Vilanterol 25 mcg (4 inhalations)|4 inhalations of 25 mcg strength
16223427|NCT01212731|Radiation|Proton Treatment Plans|20 subjects from Cohort 1 will receive proton treatment plans with malignancies involving the base of skull.
16223267|NCT01213836|Drug|Seroquel XR- quetiapine fumarate extended release|Seroquel XR dose 400-700 mg (in tablet form). The investigator established the dosing schedule for each patient depending on the patient's dose when entering the study. The patients continued on the same dose during the study as they had prior to enrolment. Dose taken once a day for 10-16 days.
16223268|NCT01213836|Drug|Seroquel IR - quetiapine fumarate|Seroquel IR dose 400-700 mg (in tablet form). The investigator established the dosing schedule for each patient depending on the patient's dose when entering the study. The patients continued on the same dose during the study as they had prior to enrolment. Dose taken twice a day for 10-16 days.
16223269|NCT01213836|Drug|Placebo matching Seroquel XR|Placebo matching Seroquel XR dose 400-700 mg (in tablet form). Dose taken once a day for 10-16 days.
16223270|NCT01213836|Drug|Placebo matching Seroquel IR|Placebo matching Seroquel IR dose 400-700 mg (in tablet form). Dose taken twice a day for 10-16 days.
16223271|NCT01213823|Other|Does not apply|This is a non-interventional study, therefore the intervention type / name do not apply
16223272|NCT01213823|Other|Does not apply|This is a non-interventional study, therefore the intervention type / name do not apply
16223273|NCT01213810|Biological|Zostavax|Biological/Vaccine
16223274|NCT01213784|Other|all antidiabetic drugs will be appliable|We expect all participants to be set on insulin during the intervention, however all types of insulin and other antidiabetics can be used goal: Hba1c lower than 7,5%
16223275|NCT01213771|Procedure|Preoperative preparation 2010|Preoperative optimisation Supportive care LEAN in patient pathways
16223276|NCT01213758|Other|Measuring liver function by PET/CT|Measuring liver function by use of FDGal and PET/CT before, 1 month and 3 months after stereotactic radiotherapy for liver tumors
16223277|NCT01213745|Other|Intervention|
16223278|NCT01213745|Other|Attention|
16223279|NCT01213745|Other|Control|
16223280|NCT01213732|Other|Isolated inferior limb perfusion|Single Melphalan bolus perfused for 60 min after 30 min of L19TNFα bolus. Intra-arterial (IA) infusion via bolus at 39˚C to 40˚C (mild hyperthermia).
16223281|NCT01213719|Dietary Supplement|creatine|20g/d throughout 10 days
16223282|NCT01213719|Dietary Supplement|betaine|2g/d throughout 10 days
16223283|NCT01213719|Dietary Supplement|dextrose|dextrose (placebo), 20 g/d throughout 10 days
16223284|NCT01213719|Dietary Supplement|creatine plus betaine|creatine (20g/d) plus betaine (2g/d) throughout 10 days
16223285|NCT01213706|Device|Whole Body Periodic Acceleration (WBPA)|Subjects will undergo to the Whole Body Periodic Acceleration platform for treatment (shaking period) for 45 min.
16223286|NCT01213706|Device|Sham WBPA|The subjects will rest for 45 minutes in the Whole Body Periodic Acceleration (WBPA) platform without movement as a control challenge.
16223287|NCT01213693|Drug|Salmeterol/Fluticasone combination|Salmeterol/Fluticasone 50/500 mcg 1 inhalation bid
16223288|NCT01213693|Drug|Salmeterol|Salmeterol 50 mcg 1 inhalation bid
16223289|NCT01213680|Drug|Monofer (iron isomaltoside 1000)|1000 mg iron isomaltoside administered as a infusion over 15 minutes
16223290|NCT01213680|Drug|Monofer|500 mg iron isomaltoside 1000 given as bolus injection over 2 minutes
16223291|NCT01213667|Drug|Ranibizumab|upload (three monthly injections), re-treatment as needed
16223292|NCT01213628|Device|humidified warmed CO2|Additional insufflation of humidified carbon dioxide (approx. 30ºC, approx. 80-100% relative humidity) via a simple humidifier (sterile water in plastic bottle) connected to a gas diffuser (Cardia Innovation AB) that is able to create a local atmosphere of 100% carbon dioxide (humidified) in the wound cavity.
16223293|NCT01213615|Device|Valve replacement|Aortic valve replacement of Hancock II Ultra porcine bioprosthesis
16223294|NCT01213576|Drug|Albendazole 400mg and ivermectin 200mcg/kg|400 mg orally given annually
16223295|NCT01213576|Drug|Albendazole and ivermectin|albendazole 800 mg and ivermectin 400mg orally given annually
16223296|NCT01213576|Drug|Albendazole 400mg and ivermectin 200mcg/kg|Albendazole 400mg and ivermectin 200mcg/kg given twice a year
16223297|NCT01213576|Drug|albendazole 800mg and ivermectin 400mcg/kg bi-annually|albendazole 800mg and ivermectin 400mcg/kg given twice a year
16223298|NCT01213563|Drug|Actrapid insulin+Gloucose|On admission to hospital all pre-operative oral antidiabetic agents and insulin are stopped and glucose monitoring is carried out every four hours at the same time as routine observations. Actrapid insulin+ Glucose is administered as per standard sliding scale (Appendix A). Just prior to discharge, total insulin administered over the previous 24 hour post-operative period is calculated. Based on the results of ward based glucose monitoring, post-operative patients can be divided in two broad categories.
16223299|NCT01213563|Drug|Actrapid insulin|On admission to hospital all pre-operative oral antidiabetic agents and insulin are stopped and glucose monitoring is carried out every four hours at the same time as routine observations. Actrapid insulin is administered as per standard sliding scales (appendix A). Just prior to discharge, total insulin administered over the previous 24 hour post-operative period is calculated. Based on the results of ward based glucose monitoring patients are discharged home on metformin 1000mg BID and/or the equivalent amount of Glargine insulin requirement in previous 24 hours prior to discharge.
16223300|NCT01213550|Drug|Chlorhexidine gluconate|
16223301|NCT01213550|Drug|Placebo mouthrinse|
16223302|NCT01213524|Behavioral|sensorimotor replacement|denicotinized cigarettes
16223303|NCT01213524|Drug|42 mg transdermal nicotine replacement|2 21-mg nicotine patches
16223304|NCT01213524|Drug|Placebo transdermal nicotine|2 placebo patches matched to 21-mg nicotine patches
16223305|NCT01213524|Other|usual brand smoking|participant smokes usual brand of cigarette
16223306|NCT01213511|Procedure|Coronary artery bypass grafting with the use of minimal extracorporeal circulation|The MECC system (Maquet Cardiopulmonary, Hirlingen, Germany) consists of a pre-connected closed CPB circuit containing a RotaFlow centrifugal pump and a Quadrox D diffusion membrane oxygenator. A flow meter and a bubble sensor are integrated in the drive unit of the centrifugal pump. The system features a tip-to-tip heparin coating (Bioline Coating, Maquet Cardiopulmonary, Hirlingen, Germany). No arterial or venous line filters are included. Initial priming volume of the system is 500 mL, while using retrograde autologous priming (RAP) the circuit could be filled in with autologous blood, thus reducing hemodilution. Since no cardiotomy suction is used, shed blood is collected with a cell-saving device (Haemonetics Corp, Braintree, MA).
16223547|NCT01211600|Other|Staples|Interrupted Ethicon Staples
16223307|NCT01213511|Procedure|Coronary artery bypass grafting under conventional extracorporeal circulation|A standard open CPB circuit is used, consisting of uncoated PVC tubing, a hard-shell venous reservoir, a microporous membrane oxygenator (Dideco, Mirandola, Italy) and a roller pump (Stöckert S3, Munich, Germany). The circuit contains a 40 μm arterial line blood filter (Dideco, Mirandola, Italy) and it is primed with 1500 mL of a balanced crystalloid/colloid solution (1000 mL of Ringer's solution, 200 mL of mannitol 20%, and 300 mL of hydroxyethyl starch 6%). Cardiotomy as well as sump sucker are integrated to the circuit.
16223308|NCT01213498|Drug|Atorvastatin|Zarator, 80 mg pr. day for 5 days
16223309|NCT01213498|Drug|Unikalk|1 tablet Unikalk pr day for 5. days
16223310|NCT01213472|Biological|GSK Biologicals' 2241658A Antigen-Specific Cancer Immunotherapeutic (ASCI)|Up to 24 intramuscular administrations
16223311|NCT01213459|Procedure|Cervical samples|Human papillomavirus detection and typing in cervical samples.
16223312|NCT01213459|Other|Data collection|Questionnaire completion
16223313|NCT01213446|Biological|Biostate|"PK component: Single bolus infusion of 80 IU VWF:RCo/kg administered intravenously on Day 1, and approximately Day 180 in Type 3 VWD subjects only.
~Efficacy component: Repeated bolus doses over 12 months as required to manage VWD condition."
16223314|NCT01213433|Drug|Artesunate-Amodiaquine|Coformulated AQ+AS by Sanofi-Aventis has been pre-qualified by WHO in 2008.It is administered once daily for three consecutive days, and it is available in three different dosages (25mg/67.5mg; 50mg/135mg; 100mg/270mg)
16223315|NCT01213420|Other|Nivea Cream for scar hydration|3 applications per day during 6 months
16223316|NCT01213420|Other|Aloë Vera FORMULA F-BC-096 for scar hydration|3 applications per day during 6 months.
16223317|NCT01213420|Other|Eucerin Calming cream for scar hydration|3 applications per day during 6 months
16223318|NCT01213420|Other|Aloë Vera with modified preservative for scar hydration|3 applications per day during 6 months
16223319|NCT01213407|Drug|Trivax, Temozolomide, Surgery, Radiotherapy|"Trivax: 5 x 10e6 dendritic cells, intranodal in 500 µl NaCl, weeks 7, 8, 9, 10, 12, 16, 20, 24, 28, 32
~Irradiation: 2 Gy per fraction once daily, five days per week (Mo-Fr), weeks 1, 2, 3, 4, 5, 6, total dose 60 Gy
~Temozolomide concomitant to radiotherapy: 75 mg/m²/day, 5 days per week (Mo-Fr), weeks 1, 2, 3, 4, 5, 6.
~Break: weeks 7, 8, 9, 10.
~Temozolomide adjuvant: 150 mg/m²/day, five days per week (Mo-Fr), week 11; 200 mg/m²/day, five days per week (Mo-Fr), weeks 15, 19, 23, 27, 31."
16223320|NCT01213407|Drug|Temozolomide, Surgery, Radiotherapy|"Irradiation: 2 Gy per fraction once daily, five days per week (Mo-Fr), weeks 1, 2, 3, 4, 5, 6, total dose 60 Gy
~Temozolomide concomitant to radiotherapy: 75 mg/m²/day, 5 days per week (Mo-Fr), weeks 1, 2, 3, 4, 5, 6
~Break: weeks 7, 8, 9, 10
~Temozolomide adjuvant: 150 mg/m²/day, five days per week (Mo-Fr), week 11; 200 mg/m²/day, five days per week (Mo-Fr), weeks 15, 19, 23, 27, 31"
16223321|NCT01213394|Drug|mycophenolate mofetil|"Introduction of CellCept or increase in the dose of CellCept to a maximum of 2 g/day. In patients not already receiving CellCept, azathioprine (AZA), enteric-coated mycophenolate sodium (EC-MPS) or sirolimus (SRL) will be discontinued and replaced by CellCept in divided doses to a maximum of 2 g/day. CNI doses will be reduced to conform to the target trough levels in the low-dose CNI arms of the ELITE-Symphony study +/- steroid dose reduction. Any CNI dose change will require measurement of CNI trough levels at 7 days post dose change +/- 3 days.
~Target CNI trough levels in the Symphony study:
~Low-dose CsA: Initial oral dose of 1-2 mg/kg bid, to achieve a target trough level of 50-100 ng/mL.
~Low-dose TAC: Initial oral dose of 0.1 mg/kg/day divided into two doses* with a target trough level of 3-7 ng/mL (*Advagraf may also be used at a dose of 0.1 mg/kg once daily with a target trough level of 3-7 ng/mL)"
16223322|NCT01213394|Other|standard immunosuppression|Current immunosuppressive therapy will be maintained throughout the study unless a change is required for safety reasons.
16223323|NCT01213381|Drug|Iniparib (SAR240550 - BSI-201)|"Pharmaceutical form:sterile aqueous solution
~Route of administration: intravenous"
16223324|NCT01213381|Drug|Gemcitabine|"Pharmaceutical form:sterile aqueous solution
~Route of administration: intravenous"
16223325|NCT01213381|Drug|Carboplatin|"Pharmaceutical form:sterile aqueous solution
~Route of administration: intravenous"
16223326|NCT01213368|Drug|DRONEDARONE (SR33589)|"Pharmaceutical form: tablets
~Route of administration: oral"
16223327|NCT01213368|Drug|placebo|"Pharmaceutical form: tablets
~Route of administration: oral"
16223328|NCT01213355|Drug|Placebo|Capsule, single dose, oral, 1 day
16223329|NCT01213355|Drug|Scopolamine|injectable subcutaneous formulation, single dose, 1 day
16223330|NCT01213355|Drug|PF-05212377|5 mg, PF-05212377, capsule, single dose, 1 day
16223331|NCT01213355|Drug|Scopolamine|injectable subcutaneous formulation, single dose, 1 day
16223332|NCT01213355|Drug|PF-05212377|20 mg, capsule PF-05212377, single dose, 1 day
16223333|NCT01213355|Drug|scopolamine|injectable subcutaneous formulation, single dose, 1 day
16223334|NCT01213355|Drug|PF-05212377|60 mg PF-05212377, capsule, single dose, 1 day
16223335|NCT01213355|Drug|scopolamine|injectable sub cutaneous formulation, single dose, 1 day
16223336|NCT01213355|Drug|Donepezil|Tablet, 10mg, single dose, 1 day
16223337|NCT01213355|Drug|Scopolamine|injectable sub cutaneous formulation, single dose, 1 day
16223338|NCT01213342|Dietary Supplement|Omega-3 Fatty Acid|"Each patient will be instructed to take 4 soft gel capsules per day (2 with the morning meal and 2 with the evening meal). They will continue this regimen for 8 weeks. The total daily amount included in 4 soft gels includes:
~EPA (Eicosapentaenoic Acid) 1300mg
~DHA (Docosahexaenoic Acid) 900 mg
~Other Omega-3's 360mg
~Total Omega 3's 2560 mg"
16223339|NCT01213342|Dietary Supplement|Soybean Soft Gels|Each patient will be instructed to take 4 soft gel capsules per day (2 with the morning meal and 2 with the evening meal. The main ingredient in the placebos is soybean oil (95.6%).
16223340|NCT01213329|Drug|Alemtuzumab|All kidney transplant recipients received one 30mg dose (IV push) of Alemtuzumab in operating room per Standard of Care.
16223341|NCT01213316|Drug|Raltegravir|Raltegravir, 400 mg, per oral (p.o.) twice daily (b.i.d.) for 48 or 144 weeks
16223342|NCT01213316|Drug|Raltegravir|Raltegravir, 400 mg, per oral (p.o.) twice daily (b.i.d.) for 96, 144, or 48 weeks
16223428|NCT01212731|Behavioral|Neurocognitive evaluation|Verbal and Visual memory; immediate attention, working memory, and processing speed; executive functions and affect and depression.
16223429|NCT01212731|Device|Advanced MRI imaging|Anatomic Imaging, Blood volume measurements, Diffusion Tensor Imaging, DTI Image Processing
16223343|NCT01213290|Device|EUS - FNA with stylet|Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) with stylet. Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) has become a useful tool in the diagnostic evaluation of gastrointestinal tract lesions as well as other accessible organ sites and has found a wide use in the management of various gastrointestinal and non-gastrointestinal lesions.
16223344|NCT01213290|Device|Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA)|Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA)without stylet. Endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) has become a useful tool in the diagnostic evaluation of gastrointestinal tract lesions as well as other accessible organ sites and has found a wide use in the management of various gastrointestinal and non-gastrointestinal lesions.
16223345|NCT01213277|Other|Fast Glycator|The subjects enrolled in this study will have a fructosamine test and blood drawn to see whether they are fast glycators
16223346|NCT01213277|Other|Control|These patients will have their blood drawn to know what the normal glycation rate is in diabetic patients
16223347|NCT01213264|Other|No neuromuscular blockade (NMB)-reversal agent used|Participants whose reversal from NMB is spontaneous (no reversal agent used)
16223348|NCT01213264|Drug|Sugammadex|"Participants receive NMB-reversal agents at the discretion of the treating physician per label according to local guidelines, in accordance with routine anesthesiology practice.
~As this is a prospective observational study designed to collect data as part of routine clinical practice, the protocol does not assign which reversal agents, if any, are to be used. This intervention is associated with a cohort that is intended to include participants who receive the NMB-reversal agent sugammadex, administered according to the local clinical practice and drug product labeling."
16223349|NCT01213264|Drug|Other NMB-Reversal Agents Used in Routine Anesthesiology Practice|"Participants receive NMB-reversal agents at the discretion of the treating physician per label according to local guidelines, in accordance with routine anesthesiology practice.
~As this is a prospective observational study designed to collect data as part of routine clinical practice, the protocol does not assign which reversal agents, if any, are to be used. This intervention is associated with a cohort that is intended to include participants who receive any NMB-reversal agent other than sugammadex, and represents multiple drugs whose use and administration may vary according to local clinical practice, product availability and product labeling."
16223350|NCT01213251|Device|Single Site Pacing|Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular lead.
16223351|NCT01213251|Device|Dual Site Pacing|Subjects will be implanted with a CRT-D that delivers pacing via the Left Ventricular and Right Ventricular lead.
16223352|NCT01213238|Drug|Oxaliplatin|140 mg/m2 by Hepatic Arterial Catheter (HAI) on day 1 of a 21 day cycle.
16223353|NCT01213238|Drug|Capecitabine|Starting dose of 500 mg/m2 by mouth twice daily, on days 1 - 14 of a 21 day cycle.
16223354|NCT01213238|Drug|Bevacizumab|10 mg/kg by vein on day 1 of a 21 day cycle.
16223355|NCT01213212|Other|Caloric restriction|Caloric restriction.
16223356|NCT01213212|Other|No intervention|"Diet ad libitum"
16223357|NCT01213199|Drug|Adapalene|Adapalene Gel 0.3%
16223358|NCT01213186|Drug|high dose of MSC|Taken i.v., at week 0, 4, 12, 24, 36 and 48, at a dose of 1.5*10E6/kg for 48 weeks.
16223359|NCT01213186|Drug|low dose of MSC treatment|Taken i.v., at week 0, 4, 12, 24, 36 and 48, at a dose of 0.5*10E6/kg for 48 weeks.
16223360|NCT01213173|Drug|Succinate Metoprolol (Betaloc ZOK®)|treatment with 47.5mg for two weeks, if tolerated and without Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3, the dosage will be titrated to 95mg and last for another 6 weeks
16223361|NCT01213173|Drug|Succinate Metoprolol (Betaloc ZOK®)|Treatment with 95mg for two weeks, and if tolerated and without bradycardia symptoms presented, Systolic blood pressure<100mmHg and heart rate <45 bpm according to 12-lead Electrocardiogram at Week 3，the dosage will be force titrated to 190mg and last for another 6 weeks
16223362|NCT01213160|Drug|AZD4547|film coated tablet, PO, twice daily
16223363|NCT01213147|Drug|clomiphene citrate|100 mg per day oral for 7 days
16223364|NCT01213147|Drug|buserelin|50 µg Subcutaneous twice a day from cycle day 2 of menstrual cycle
16223365|NCT01213121|Drug|Quetiapine|oral tablet/25-600mg per day/once a day/six weeks
16223366|NCT01213108|Behavioral|Örebro prevention program|6 presentations on alcohol-specific parenting practices to parents of 13-16 year olds youth
16223367|NCT01213108|Behavioral|Business as usual|Regular alcohol prevention activities and curricula in Swedish schools
16223368|NCT01213095|Drug|rituximab|rituximab 375mg/m2, every 8 weeks, 12 times
16223369|NCT01213082|Drug|24GyE proton and Anti-VEGF|24GyE proton beam will be administered in 2 fractions 24 hrs apart 2 to 6 weeks after intravitreal anti-VEGF therapy
16223370|NCT01213082|Drug|16GyE and anti-VEGF|16GyE of Proton Beam Irradiation will be administered in 2 fractions 24 hrs apart 2 to 6 weeks after intravitreal anti-VEGF therapy
16223371|NCT01213082|Drug|Sham Irradiation and anti-VEGF|2 Sessions of Sham Proton Beam Irradiation 24 hrs apart administered 2 to 6 weeks after intravitreal anti-VEGF therapy
16223372|NCT01213069|Other|Questionnaires|The subjects are asked to fill out a questionnaire on the personal and professional situations, organ donation legislation, what happens in everyday practice, their own experience with donating their own organs, and what position they take.
16223373|NCT01213056|Behavioral|Mindfulness Based Cognitive Therapy|Cognitive Behavioral (Active treatment condition)
16223374|NCT01213043|Biological|Prolastin-C, 60 mg/kg|60 mg/kg weekly infusion of Prolastin-C for 8 weeks
16223375|NCT01213043|Biological|Prolastin-C, 120 mg/kg|120 mg/kg weekly infusion of Prolastin-C for 8 weeks
16223376|NCT01213030|Drug|[F-18] FMISO|10 mCi [F18] HX4 and 10 mCi [F-18] FMISO within 7 days of each other regardless of sequence
16223377|NCT01213030|Drug|[F-18] HX4|10 mCi [F18] HX4 and 10 mCi [F-18] FMISO within 7 days of each other regardless of sequence
16223378|NCT01213017|Drug|certolizumab pegol|400mg at week 0, 2 and 4, followed by 200 mg every two weeks for 52 weeks
16223430|NCT01212718|Drug|FUFA|2600/500 mg/m2 i.v. 24 h via port, 1 time weekly for six weeks, than have a break for 2 weeks (=8 weeks for 1 cycle)
16223431|NCT01212718|Drug|systemic chemotherapy|CPT-11, 80 mg/m2 for 90 minutes and 5 FU/FA 2000/500 mg/m2 iv. 24h via port; 1 time weekly for six weeks, than have a break for 2 weeks
16223498|NCT01211964|Drug|LEO 22811|Oral administration of solution and tablet.
16223499|NCT01211951|Drug|KCT-0809|
16223379|NCT01213004|Procedure|respiration correlated CT scan|Thoracic malignancies (study group 1): Patients to be treated for gastro-esophageal junction (GEJ) malignancy undergo an implantation procedure of two or three radiopaque markers several days prior to treatment simulation, which are used to correct patient position at treatment. At treatment simulation, patients receive a standard CT scan followed by an RCCT scan. In cases of GEJ malignancy, oral contrast is administered prior to the standard CT scan; this is done at the treating physician's discretion. The standard CT is used to design the radiation treatment plan, where as the RCCT is used to define a volume that encompasses the motion extent of the tumor with breathing and is transferred to the standard CT.
16223380|NCT01213004|Procedure|respiration correlated CT scan|Abdominal malignancies (study group 2): Patients undergo an implantation procedure of two or three radiopaque markers several days prior to treatment simulation. At treatment simulation, patients receive a standard CT scan followed by an RCCT scan. Intravenous contrast is administered prior to the standard CT; this is done at the treating physician's discretion.
16223381|NCT01212991|Drug|Enzalutamide|Participants received enzalutamide 160 mg, administered as four 40-mg capsules, once per day by mouth. Study drug treatment continued until disease progression (evidence of radiographic progression, a skeletal-related event, or clinical progression) and the initiation of a cytotoxic chemotherapy or an investigational agent, unacceptable toxicity, or withdrawal.
16223382|NCT01212991|Drug|Placebo|Participants received placebo, administered as four capsules, once per day by mouth. Study drug treatment continued until disease progression (evidence of radiographic progression, a skeletal-related event, or clinical progression) and the initiation of a cytotoxic chemotherapy or an investigational agent, unacceptable toxicity, or withdrawal.
16223383|NCT01212978|Behavioral|Pedometer to Increase Physical Activity|The pedometer will be given to arms 2 and 3 (pedometer only and pedometer+software intervention) to help them guide their increase in physical activity.
16223384|NCT01212965|Drug|Selenium|400 μg once a day for 6 months by mouth
16223385|NCT01212952|Drug|pomalidomide|Given orally
16223386|NCT01212952|Drug|bortezomib|Given IV
16223387|NCT01212952|Drug|dexamethasone|Given orally
16223388|NCT01212952|Other|laboratory biomarker analysis|Optional correlative studies
16223389|NCT01212952|Other|gene expression analysis|Optional correlative studies
16223390|NCT01212926|Device|Echographic analysis of myocardial deformation in 2D strain|
16223391|NCT01212913|Drug|INSULIN GLARGINE|Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once daily
16223392|NCT01212913|Drug|INSULIN GLULISINE|Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once daily
16223393|NCT01212913|Drug|Insulin aspart|Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: twice daily
16223394|NCT01212900|Drug|Statins, HMG CoA|Statin therapy
16223395|NCT01212887|Biological|MFE23 scFv-expressing autologous anti-CEA MFEz T lymphocytes|
16223396|NCT01212887|Biological|aldesleukin|
16223397|NCT01212887|Drug|cyclophosphamide|
16223398|NCT01212887|Drug|fludarabine phosphate|
16223399|NCT01212887|Other|laboratory biomarker analysis|
16223400|NCT01212887|Other|pharmacological study|
16223401|NCT01212874|Drug|nitroglycerin|nitroglycerin administered as an infusion following a step up/step down protocol to treat hypertension in patients undergoing cardiac surgery.
16223402|NCT01212874|Drug|esmolol|esmolol will be administered by infusion following a step up / step down protocol to control hypertension.
16223403|NCT01212861|Device|Suprachoroidal Dissection Instrument (SDI)|The Suprachoroidal Dissection Instrument (SDI) is a manually operated, non-powered, re-usable ophthalmic surgical instrument. The SDI is designed to enter a surgically exposed Schlemm's canal and be advanced up to 90 degrees around the canal from the entry site.
16223404|NCT01212848|Device|Transcranial Magnetic Stimulation|Group 1: The treatment group will receive the following dose of repetitive TMS delivered over the left prefrontal cortex: 10 Hz, 120% Motor Threshold, 5 second pulse train, 10 second intertrain (IT) interval, 30 minutes of treatment, 6000 pulses per session; three sessions each day (18,000 stimuli) for three days for a total of 54,000 stimuli.
16223405|NCT01212848|Device|Transcranial Magnetic Stimulation - Sham Comparator|"The control group will receive an identical dosing schedule of sham repetitive TMS over three days."
16223406|NCT01212835|Procedure|Sham Comparator: no ring|Open roux-en-Y gastric bypass not banded
16223407|NCT01212835|Procedure|RYGBP-RING|Vertical Roux-en-Y banded gastric bypass
16223408|NCT01212822|Biological|bevacizumab|Given IV
16223409|NCT01212822|Drug|oxaliplatin|Given IV
16223410|NCT01212822|Drug|leucovorin calcium|Given IV
16223411|NCT01212822|Drug|fluorouracil|Given IV
16223412|NCT01212822|Procedure|therapeutic conventional surgery|Undergo surgical resection
16223413|NCT01212822|Other|laboratory biomarker analysis|Correlative studies
16223414|NCT01212809|Device|Juvéderm Ultra|Split-face injection of Juvéderm Ultra into vertical lip rhytids and radial cheek lines on one side of face
16223415|NCT01212809|Device|Cosmoderm 1|Split-face injection of Cosmoderm 1 into vertical lip rhytids and radial cheek lines on one side of face
16223416|NCT01212783|Behavioral|In-Home Cognitive Behavioral Therapy|Adapted form of CBT that is delivered in the home setting, uniquely designed for young, low income new mothers, and is explicitly integrated with home visitation. IH-CBT is delivered by a masters level therapist. It consists of 15 weekly sessions and two monthly booster sessions provided after the 15th session.
16223417|NCT01212783|Behavioral|Present-Centered Therapy|Present-Centered Therapy is a supportive psychotherapy.
16223418|NCT01212770|Drug|Apremilast 20mg|Apremilast 20 mg twice daily, orally
16223419|NCT01212770|Drug|Apremilast 30mg|Apremilast 30 mg twice daily, orally
16223420|NCT01212770|Drug|Placebo|
16223421|NCT01212757|Drug|Apremilast 20mg|Apremilast 20 mg twice daily, orally
16223422|NCT01212757|Drug|Apremilast 30mg|Apremilast 30 mg twice daily, orally
16223423|NCT01212757|Drug|Placebo + 20 mg Apremilast|Placebo + 20 mg Apremilast
16223424|NCT01212757|Drug|Placebo + 30 mg Apremilast|Placebo + 30 mg Apremilast
16223425|NCT01212744|Drug|rAvPAL-PEG|0.06 mg/kg/day, 0.1 mg/kg/day, 0.2 mg/kg/day, 0.4 mg/kg/day, 0.6 mg/kg/day, 0.8 mg/kg/day
16223500|NCT01211951|Drug|KCT-0809|
16223433|NCT01212692|Behavioral|mentally stimulating activities|The study will compare the effects of different methods of mental stimulation. The intervention involves 6 classroom-style educational sessions and 10 mental stimulation studies involving computerized memory tasks.
16223434|NCT01212679|Drug|nerve growth factor|The experimental group patients will receive NGF 20ug/d intranasally for 2 weeks.
16223435|NCT01212679|Drug|nomral saline|The Placebo Comparator group patients will receive nomral saline 20ug/d intranasally for 2 weeks.
16223436|NCT01212666|Procedure|Ropivacain|Ultrasound-guided ACB; 30 mL Ropivacain 7,5 mg/mL. Single dose.
16223437|NCT01212666|Procedure|Saline|Ultrasound-guided Adductor Canal Block; 30 mL Saline. Single dose.
16223438|NCT01212653|Drug|Simponi|Golimumab 50mg monthly
16223439|NCT01212653|Other|0.9ml sodium chloride|0.9ml sodium chloride
16223440|NCT01212627|Drug|Ridaforolimus|Ridaforolimus 20 Daily, 5 days each week, (Mon-Fri) on a 28 day cycle
16223441|NCT01212614|Procedure|MRI, non invasive 13C-breath test, 24h-intragastric / esophageal pH monitoring|MRI, non invasive 13C-breath test, 24h-intragastric/esophageal pH monitoring
16223442|NCT01212588|Drug|mifepristone|Mifepristone 600mg (3x200mg tablets) once daily for seven days
16223443|NCT01212588|Drug|Placebo|3 tablets once daily for seven days
16223444|NCT01212562|Procedure|Immunocryosurgery|Assessing the efficacy of cryosurgery during continued imiquimod application (immunocrysurgery) in the treatment of basal cell carcinoma of the skin
16223445|NCT01212549|Procedure|Immunocryosurgery|2 weeks imiquimod, cryosurgery (open spray liquid nitrogen, 2 cycles, 15 secs each), 3 more weeks imiquimod
16223446|NCT01212549|Procedure|Cryoimmunotherapy|Cryosurgery(open spray liquid nitrogen, 2 cycles, 15 secs each), followed by 5 weeks imiquimod
16223447|NCT01212536|Device|Airtraq laryngoscopy|laryngoscopy and intubation
16223448|NCT01212523|Drug|propofol and isoflurane|both drugs administered at age-related dose and titrated to effect. maximum dose of propofol 15 mg/kg/hr, maximum dose of isoflurane 1.5 MAC
16223449|NCT01212510|Other|Blood sampling|blood rate of ACE, CA19-9, circulating tumor cell, circulating tumor DNA
16223450|NCT01212497|Behavioral|Mindfulness meditation coaching|Participants interact with virtual coach to obtain instruction in mindfulness meditation and coaching support.
16223451|NCT01212484|Drug|Carbidopa|The trial will be divided into two consecutive, but independent parts. Phase 1, will address the safety and tolerability of carbidopa in patients with FD using an open-label dose titration phase followed by 4-weeks of open-label treatment. Phase 2, will address the efficacy of carbidopa for the treatment of nausea in patients with FD using a randomized, placebo controlled, double blind, 4-week cross over design.
16223452|NCT01212484|Drug|Placebo|The trial will be divided into two consecutive, but independent parts. Phase 1, will address the safety and tolerability of carbidopa in patients with FD using an open-label dose titration phase followed by 4-weeks of open-label treatment. Phase 2, will address the efficacy of carbidopa for the treatment of nausea in patients with FD using a randomized, placebo controlled, double blind, 4-week cross over design.
16223453|NCT01212471|Drug|Bromfenac Ophthalmic Solution A|sterile ophthalmic solution
16223454|NCT01212471|Drug|Bromfenac Ophthalmic Solution B|sterile ophthalmic solution
16223455|NCT01212471|Drug|Placebo Comparator|sterile ophthalmic solution
16223456|NCT01212458|Drug|Rufinamid|Effect of oral rufinamide and oxcarbazepine on nerve excitability, hyperalgesia, allodynia and flare reaction compared to placebo.
16223457|NCT01212445|Drug|PEG 3350 laxative plus electrolytes (PEG + E)/Macrogol (Movicol®, BAY81-8430)|13.125 g of PEG 3350 powder with approximately 0.6 g of electrolytes
16223458|NCT01212432|Drug|Daptomycin|Daptomycin kinetics in CRRT
16223459|NCT01212406|Drug|Vitamin D|Every month 100.000 units of vitamin D in syringe Exacta-Med Oral Dispenser during 2 years and re-evaluation after 3 years
16223460|NCT01212393|Behavioral|reminders|In the intervention group, emergency departments will be provided with poster and pocket cards and, if possible, with a computer decision support system remembering venous thromboembolism prophylactic treatment.
16223461|NCT01212380|Drug|carfilzomib|Given IV infusion lasting 30 minutes. Will be administered IV at a specified dose in mg/m2 QDx2 weekly for 3 weeks (days 1, 2, 8, 9, 15, and 16). The first and second dose will always be administered at 20 mg/m2.
16223462|NCT01212380|Other|Cytokine Assessment|TNF-α,IFN-γ,IL-6,IL-8,IL-10,and IL-1β pre-dose, completion, 30 minutes, 2 hours, 6 hours, and approximately 24 hours from initiation of therapy on days 1 and 8 of treatment. These will be assessed utilizing standard ELISA or flow cytometry methodology. Other cytokines or soluble factors may be assessed that relate to drug toxicity or response. After 6 patients are examined in each group, the time points or number of cytokines examined may be changed to decrease time points examined. Cytokines will be examined by a multiplex flow cytometry assay or ELISA. Other cytokines, chemokines, or soluble factors may be assessed on residual material not used for these studies.
16223463|NCT01212380|Other|Pharmacodynamic Studies|Based upon our preliminary data changes occuring in vivo during carfilzomib treatment will be determined and if their occurrence correlates with both clinical response and development of cytokine release. These studies will be performed from CD19 selected CLL cells at screening, pre-treatment, 4 hours, and 24 hours post-therapy on days 1 and 8 of treatment; end of therapy evaluation, and at time of relapse (in responding patients). These studies will include assessment of NF-κB (p50/p65 binding; I-κB level, P-I-κB level, select target genes), p53 (p53 nuclear levels, p53 nuclear binding, and select target genes), p73, and ER stress response. Standard Western Blot, EMSA, RT-PCR will be done to complete these studies.
16223464|NCT01212380|Other|Proteosome Inhibition Assessment|Proteosome inhibition on CLL cells will be examined at screening, pre-treatment and post-treatment (immediately after completion of drug) days 1, pre-treatment day 2, day 3 (optional), day 5 (optional),pre and post-treatment days 8, pre and post-treatment days 9, day 10 (optional),day 12 (optional), and day 15 (optional).
16223488|NCT01212133|Drug|liraglutide|Self-administered subcutaneously (under the skin) once daily at any time, independent of meals, in the abdomen, thigh or upper arm.
16223489|NCT01212120|Biological|Genetic profiling of bacterial cultures|Genetic profiling of bacterial cultures harvested from both the nose and foot lesions of patients
16223490|NCT01212107|Drug|FGF Receptor|LY2874455 administered orally.
16223491|NCT01212107|Drug|Phosphate Binders|
16223492|NCT01212094|Drug|Rituximab|
16223493|NCT01212094|Other|normal saline|normal saline
16223465|NCT01212380|Other|Pharmacogenomic Studies|Germ line DNA from a buccal swab and bone marrow fibroblasts will be obtained at baseline screening for possible examination of SNP polymorphisms that may correlate with response and toxicity to carfilzomib therapy. Tumor DNA will be derived from samples obtained at baseline for the p53 mutational studies. SNPs related to drug metabolism, response, or toxicity to therapy, cytokine release, and tumor biology may be examined. Other SNPs may be used in the future. Given the potential for contamination in the recipient, recipient DNA from a buccal swab and/or saliva will be obtained at baseline screening for examination of SNP polymorphisms that may correlate with response, toxicity, and pharmacokinetics.
16223466|NCT01212367|Biological|SCH 721015|1.0 x 10e12 viral particles on Days 1 and 4
16223467|NCT01212367|Biological|SCH 721015|3.0 x 10e11 viral particles on Days 1 and 4
16223468|NCT01212354|Radiation|Radiotherapy|7 weeks Radiation dose escalation (5 x 2.3 Gy up to 80.5 Gy total dose)
16223469|NCT01212341|Biological|Allogeneic NK cells|
16223470|NCT01212328|Other|Care Coordinator + Decision Support Software|Care coordinator + Decision Support Software (Experimental Arm): The patients will receive integrated diabetes care management consisting of current diabetes management guidelines + Non-Physician care coordinator assistance + Electronic Health Records- Decision Support Software (EHR-DSS) (The software will generate diabetes management prompts for the treating physician and reminders for clinic visits for the intervention arm patients.)
16223471|NCT01212328|Other|Usual care|Usual care (Active Comparator Arm): Patients will continue with the usual diabetes care with no care coordinator assistance and no decision support software - management prompt.
16223472|NCT01212315|Device|Triclosan coated sutures|Subcutaneous and cutaneous sutures coated with triclosan (Vicryl Plus / Monocryl Plus) are used to close the incisions after vein harvesting and sternotomy. All wounds are inspected before discharge from hospital and the patients are instructed to contact the study coordinator if any suspected infection occurs. In addition, all patients are controlled after thirty days by a nurse and contacted by telephone sixty days after surgery to assess postoperative infections by a predefined questionnaire. Infection symptoms are graded according to the Asepsis score and the CDC classification. Patient records including bacterial cultures and antibiotic treatment are collected for all patients with suspected infections.
16223473|NCT01212302|Drug|Optimizing ASA and clopidogrel treatment|"ASA 100 mg, ASA 300 mg, ASA 500 mg
~Clopidogrel 75 mg, Clopidogrel 150 mg, Ticlopidine 2x 250 mg, Prasugrel 10 mg. Intervention List:
~In the case of clopidogrel low-response, the maintenance dose was doubled (repeated loading dose followed by 150 mg daily), and when still ineffective ticlopidine or prasugrel, if available and not contraindicated, were used. ASA low-responders were treated by increasing the dose to 300 mg in a first step or to 500 mg ASA when the first modification was not sufficient."
16223474|NCT01212276|Drug|MORAb-028|Cohort 1: 0.1 mg/kg IV on study day 1 only Cohort 2: 0.2 mg/kg IV on study day 1 only Cohort 3: 0.5 mg/kg IV on study day 1 only Cohort 4: 1.0 mg/kg IV on study day 1 only
16223475|NCT01212263|Drug|Step-up HP u FSH|HP u FSH (Fostimone 75 IU ,IBSA Institut Biochimique SA-CH 6903 Lugano) in doses of 37.5 IU (half ampole) im /day statrted from second day of the cycle for 7 days ,then increased to 75 IU for another 7 days ,then to 112.5 IU (one and half ampoule) untilleading follicle mean diameter reaches 18 mm
16223476|NCT01212263|Drug|Clomiphine citrate plus low dose uFSH|Clomiphene citrate 50 mg tab oral tablets(Clomid 50 mg tablets Global Napi , Egypt) two tablets(100 mg) /day are started from the 2nd day of cycle for 5 days togeteher with 37.5 IU HP uFSH (Fostimone 75 IU IBSA)/day for 8 days and may be extended to 10-12 days until leading follicle diameter reaches 18 mm
16223477|NCT01212250|Drug|carvedilol|Carvedilol will be administered orally at a start dose of 3.125 mg twice daily. After 1 week, this will increased if systolic blood pressure does not fall below 90 mm Hg. The patient will receive the maximum tolerated dose of carvedilol with a maximum of 6.25 BD.
16223478|NCT01212250|Drug|Placebo|The placebo tablets will be identical to the carvedilol tablets. First the patients will receive placebo in the dose of 1 BD. Then depending on his tolerance it will be increased to a maximum of 2 BD.
16223479|NCT01212237|Procedure|fMRI Evaluation|Functional magnetic resonance imaging (fMRI) uses MR imaging to measure the tiny metabolic changes that take place in an active part of the brain. fMRIs are used for many reasons, for example, to determine precisely which part of the brain is handling critical functions such as thought, speech, movement and sensation, to help assess the effects of stroke, trauma or degenerative disease (such as Alzheimer's) on brain function, and to guide the planning of surgery and radiation therapy.
16223480|NCT01212211|Other|change in drug therapy|Change in drug therapy with the help of the opinion of pharmacologists : the physician would review the drug treatment of ten residents in coordination with the opinion of pharmacologists
16223481|NCT01212185|Drug|intranasal oxytocin spray|6 insufflations (24 IU of oxytocin total) given twice daily for 3 days
16223482|NCT01212185|Other|intranasal spray without oxytocin|6 insufflations (0.1 metered dose/insufflation) twice daily
16223483|NCT01212172|Device|Soprano/SHR|For the Soprano, the constant motion technique will be used with a fluence ranging between 6 J/cm2 and 10 J/cm2, 10 Hz, 20 ms pulse duration. The constant motion technique involves treating 100 cm2 areas with multiple passes until reaching the cumulative energy dose of 8 kJ. Thus, the hand piece is kept in constant motion to deliver continuous low fluence that will build up energy over time.
16223484|NCT01212172|Device|LightSheer|The LightSheer/Duet will be used with conventional single pass (stamping) of the handpiece using settings of single pulse fluence of up to 14 J/cm2 and low vacuum settings.
16223485|NCT01212159|Device|Self Monitoring Lipid Analyzer|The device is similar to a glucometer- Utilizing a lancet a small amount of blood is collected in a capillary tube and placed on a hand held monitor that records lipid values.
16223486|NCT01212146|Dietary Supplement|Lactobacillus paracasei IMPC 2.1 LMGP22043|participants will complement their usual lifestyles and dietary intakes with probiotic artichokes, enriched with the probiotic strain Lactobacillus paracasei IMPC2.1 (LMGP22043). The product contains approximately 1.20 x 10^8 CFU of live probiotic cells of Lactobacillus paracasei IMPC 2.1 LMGP22043 per gramme, which resulted in a daily dose of about 2 x 10^10 CFU.
16223487|NCT01212146|Dietary Supplement|Ordinary artichokes|Probiotic artichokes will be tested against ordinary artichokes (probiotic free) of identical shape, texture, and appearance produced by the same manufacturer. Artichokes will be put in similar packages and there will be no way to distinguish between the two products.
16223503|NCT01211938|Radiation|single-fraction radiotherapy with concomitant 5FU and Hydrea|single-fraction radiotherapy with concomitant 5FU and Hydrea
16223504|NCT01211938|Radiation|hyperfractionated radiotherapy with concomitant Cetuximab|hyperfractionated radiotherapy with concomitant Cetuximab
16223505|NCT01211925|Procedure|distal venous arterialisation|The investigators perform reverse revascularisation of the ischemic limb with arterial blood supply from patent in flow artery to the superficial dorsal venous arch.
16223506|NCT01211925|Drug|Aspirin|100 mg per day continuous
16223507|NCT01211912|Drug|Arm 1 (20 patients)|Acetaminophen 1000 mg by mouth once
16223508|NCT01211912|Drug|Arm 2 (34 patients)|Acetaminophen 1000 mg by mouth once
16223509|NCT01211873|Drug|Dotarem (gadoterate meglumine)|0.1 mmol/kg by body weight, single IV injection
16223510|NCT01211873|Drug|Magnevist (gadopentetate dimeglumine)|0.1 mmol/kg by body weight, single IV injection
16223511|NCT01211860|Drug|Diazoxide Choline Controlled-Release Tablet|DCCR 290 mg once a day for 10 days
16223512|NCT01211847|Drug|Diazoxide Choline Controlled-Release Tablet|DCCR 290 mg once a day for 126 days
16223513|NCT01211847|Drug|Placebo|Placebo matching DCCR
16223514|NCT01211834|Drug|tocilizumab|intravenously at dose of 8mg/kg over 1 hour infusion every 4weeks
16223515|NCT01211834|Drug|DMARDs|Methotrexate(MTX) and/or 1 DMARDs(chloroquine, hydroxychloroquine, parenteral gold, sulfasalazine, azathioprine, and leflunomide)
16223516|NCT01211834|Drug|Placebo|intravenously over 1 hour infusion every 4weeks
16223517|NCT01211834|Drug|DMARDs|Methotrexate(MTX) and/or 1 DMARDs
16223518|NCT01211821|Drug|metoprolol|Tablets, Oral, 200 mg, once, 1 day
16223519|NCT01211821|Drug|BMS-914392|Tablets, Oral, 60 mg, once daily, 7 days
16223520|NCT01211808|Drug|BMS-914832|Tablets, Oral, 30 mg, once, 1 day
16223521|NCT01211808|Drug|Diltiazem|Tablets, Oral, 360 mg, once daily, 10 days
16223522|NCT01211795|Drug|topical intraoral ketoprofen gel|20% ketoprofen oral gel is applied once daily by cotton swab to a branch of the trigeminal nerve on the maxillary gingival mucosa above the 2nd and 3rd molars. The swab is held in place for 2 minutes at the same time once daily.
16223523|NCT01211795|Other|Placebo Gel|An identical oral gel, without ketoprofen, or 'placebo gel' is applied using a cotton swab, once daily to a branch of the trigeminal nerve on the maxillary gingival mucosa. It is held in place for 2 minutes, once daily.
16223524|NCT01211782|Drug|caprylic triglyceride|oral, 20 gm, daily x 6 months
16223525|NCT01211782|Drug|long-chain triglyceride|oral, 14 gm, daily x 6 months
16223526|NCT01211769|Drug|Naltrexone|A pill of naltrexone chlorhydrate 50mg, associated to yellow liquid paraffin pills simulating borage seed and fish oil.
16223527|NCT01211769|Drug|PUFAs|Borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram and Fish oil 1 gram - rich in omega 3 PUFAs; associated to a pill with 50mg of talcum powder, identical to the pill of naltrexone.
16223528|NCT01211769|Drug|Placebo|A pill with 50mg of talcum powder, identical to the pill of naltrexone; associated to PUFAs Placebo pills (yellow liquid paraffin identical to the pills of borage seed and fish oil).
16223529|NCT01211769|Drug|Naltrexone + Placebo|A pill of naltrexone chlorhydrate 50mg, associated to Borage Oil (Borago officinalis L. Boraginaceae) - rich in omega 6 PUFA, dosage of 1 gram and Fish oil 1 gram - rich in omega 3 PUFAs.
16223530|NCT01211756|Drug|Oxytocin|20 IU BID for one week, followed by 40 IU BID for 3 weeks.
16223531|NCT01211756|Drug|Placebo|20 IU BID for one week, followed by 40 IU BID for 3 weeks.
16223532|NCT01211743|Other|Laparoscopic cholecystectomy|Standard 4 port laparoscopic cholecystectomy
16223533|NCT01211743|Other|Single incision laparoscopic cholecystectomy|One port placed through the umbilicus
16223534|NCT01211730|Drug|Insulin|Insulin initially as continuous infusion for first 24-48 hours followed by subcutaneous administration once subjects eating and out of intensive care unit.
16223535|NCT01211717|Dietary Supplement|Branched Chained Amino Acids|Two doses of the Branched Chained Amino Acid supplement will be taken. The first dose will be taken 35 minutes before the intended exercise, and the other dose will be taken right after completing the exercise. The amount of the Branched Chained Amino Acid supplement administered to the subjects in the experimental group will vary from one person to the other but a total dose of 1 gram of BCAA per kilogram of lean body mass will be used. This dose will be divided in half and administered at the two specified occasions. The ratio of isoleucine, leucine, and valine will be 1:2.5:1 respectively
16223536|NCT01211717|Other|Cellulose Placebo mix|The control group will also take 2 doses, 1 before the exercise, and the other after completing the exercise. This dose will be divided in half and administered at the two specified occasions.
16223537|NCT01211704|Drug|Paliperidone Palmitate|NVEGA® SUSTENNA™ or placebo in equivalent ml doses according to the following schedule: Day 1: INVEGA® SUSTENNA™ 234mg vs. placebo injection (equivalent ml); Day 8 (week 1) INVEGA® SUSTENNA™ 156mg vs. placebo injection (equivalent ml); Day 36 (week 5): INVEGA® SUSTENNA™ 117 mg vs. placebo injection (equivalent ml) ( this latter dose could range from 39mg to 156mg according to tolerability and clinical symptoms of bipolar disorder). Treatment with INVEGA® SUSTENNA™ /Placebo will last 5 weeks.
16223538|NCT01211704|Drug|Placebo|Placebo in equivalent ml doses to experimental intervention (Paliperidone Palmitate)
16223539|NCT01211691|Drug|KB004, Monoclonal Antibody|
16223540|NCT01211665|Drug|Methylprednisolone|In intravenous form (for a daily dose of 1 g/day on treatment days).
16223541|NCT01211665|Drug|Prednisolone|Oral prednisolone used as a taper, with suggested dosages starting at 80 mg and tapering to 5 mg.
16223542|NCT01211626|Drug|ANA773|ANA773 Tosylate Capsule
16223543|NCT01211626|Drug|Placebo|Matching Placebo Capsule
16223544|NCT01211613|Procedure|Manual Manipulation|Doctor of chiropractic will apply manual high-velocity low-amplitude thrust to lumbar spine of research participants.
16223545|NCT01211613|Device|Mechanically-assisted manipulation|Doctor of chiropractic will use the Activator Instrument to apply a mechanically-assisted thrust to the lumbar spine of research participants.
16223546|NCT01211613|Other|Standard Medical Care|Patients will receive an examination with a physician who is board certified in physical medicine and rehabilitation. Treatment will consist of medical monitoring of the patient's condition over 4 weeks (baseline and 2 follow up exams) and a prescription for over-the-counter anti-inflammatory medications if indicated.
16223548|NCT01211600|Other|Suture|Subcuticular continuous suture (4-0 Monocryl Plus on PS2 needle or 4-0 Vicryl Plus on FS2 or PS2 needle)
16223549|NCT01211587|Drug|safinamide|Safinamide will be provided in tablets equivalent to 50 mg in blisters. After randomization, patients receiving safinamide will take two 50 mg tablets once per day for 12 weeks (weeks 1-12). During the open label phase, patients will receive 100mg of safinamide once per day (two 50 mg tablets) for 12 weeks (weeks 13-24).
16223550|NCT01211587|Drug|placebo|Identical placebo tablets will be provided in blisters. After randomization, patients receiving placebo will take two tablets once per day for 12 weeks (weeks 1-12). During the open label phase, patients will receive 100mg of safinamide once per day (two 50 mg tablets) for 12 weeks (weeks 13-24).
16223551|NCT01211574|Behavioral|peer coach|Participants will receive behavioral weight loss treatment and be coached by a peer between treatment visits.
16223552|NCT01211574|Behavioral|mentor|Participants will receive behavioral weight loss treatment and be coached by a mentor between treatment visits.
16223553|NCT01211574|Behavioral|Professional|Participants will receive behavioral weight loss treatment and be coached by a behavioral weight loss interventionist between treatment visits.
16223554|NCT01211561|Drug|Selenium, selenomethionine|Patients will receive one 200 ug pill of Selenomethionine
16223555|NCT01211561|Drug|placebo|Patients will be given one 200 ug placebo pill each day for 6 months
16223556|NCT01211548|Other|contrast CTA of the CAP|CT coronary angiography results will be reported for all patients by adjudicators blinded to their inclusion in the study.
16223557|NCT01211535|Device|OPTI-FREE RepleniSH multipurpose solution|FDA-approved, multipurpose solution used as indicated for cleaning, rinsing, conditioning, disinfecting, and storing study contact lenses on a daily wear basis for 14 days
16223558|NCT01211535|Device|ReNu Biotrue multipurpose solution|FDA-approved, multipurpose solution used as indicated for cleaning, disinfecting, daily protein removing, and storing study contact lenses on a daily wear basis for 14 days
16223559|NCT01211535|Device|Silicone hydrogel contact lenses|Silicone hydrogel contact lenses per subject's habitual brand and prescription worn on a daily wear basis for 14 days, with either OPTI-FREE RepleniSH or ReNu Biotrue used for contact lens care
16223560|NCT01211522|Drug|Haloperidol|Haloperidol, up to 10mg q12 hours, will be administered intravenously (IV) by bolus over up to 5 minutes at concentrations of 5mg/mL. Patient will only receive IV while in the ICU.
16223561|NCT01211522|Drug|Ziprasidone|Ziprasidone, up to 20mg q12 hours, will be administered intravenously (IV) by bolus over up to 5 minutes at concentrations of 10mg/mL. Patient will only receive IV while in the ICU.
16223562|NCT01211522|Drug|Placebo|Placebo, up to 10mL q12 hours, will be administered intravenously (IV) by bolus over up to 5 minutes. Patient will only receive IV while in the ICU.
16223563|NCT01211509|Drug|Montelukast|After diagnosis of fBOS every day an oral capsule with 10 mg montelukast of placebo
16223564|NCT01211496|Behavioral|High-speed power training|High speed resistance training, 3 sessions per week for 12 weeks
16223565|NCT01211496|Behavioral|Slow-speed strength training|Slow speed resistance training, 3 sessions per week for 12 weeks
16223566|NCT01211483|Drug|U3-1287|Liquid 70 mg/mL for IV infusion at high dose or low dose
16223567|NCT01211483|Drug|Erlotinib|Tablet 150 mg for oral administration
16223568|NCT01211483|Drug|Placebo|Placebo liquid matching U3-1287 for IV infusion
16223569|NCT01211470|Drug|Daptomycin|Active Comparator: Daptomycin.
16223570|NCT01211470|Drug|PMX-30063-investigational drug|Experimental: PMX-30063
16223571|NCT01211457|Drug|sapacitabine and decitabine (Part 1 - completed)|decitabine will be administered in alternating cycles with sapacitabine
16223572|NCT01211457|Drug|sapacitabine and venetoclax (Part 2 - recruiting)|sapacitabine will be administered concomitantly with venetoclax
16223573|NCT01211444|Device|HGNS Treatment|The Apnex Hypoglossal Nerve Stimulation System (HGNS) is an implanted medical device that is designed to prevent the tongue from blocking the airway during sleep. It is fully automatic and can be implanted during a simple surgical procedure. After it is implanted, the device is programmed to meet the unique needs of each patient. The device is on when the patient is sleeping and off when the patient is awake.
16223574|NCT01211431|Drug|Reference|Intrathécale morphine is used for post-cesarean pain control
16223575|NCT01211431|Drug|Experimental|A solution including both ropivacain and diclofenac continuously delivered to the wound is used for post-cesarean pain control
16223576|NCT01211418|Behavioral|Integrative Meditation|"Stage 1: Treatment Engagement and Detoxification. Use 6 breaths/minute as near resonant-frequency.
~Stage 2: Recovery and transition by reducing craving and irritability. Wk 3: introduce 16-mins IM. Wk 4: RFB & IM as a coping tool. Wk 5: add guided imagery into IM. Wk 6: review and catch-up if miss any prior sections.
~Stage 3: Revitalization and Relapse Prevention. Wk 7: customize guided imagery. Wk 8: introduce full version of IM. Wk 9: techniques of handling random thoughts during meditation and learn to separate thoughts from action. Wk 10: how to use IM techniques to handle different relapse triggers. Wk 11: different ways to integrate IM technique into daily life. Wk 12: review, feedback, and provide local sources for more meditation practice and study."
16223577|NCT01211418|Behavioral|Supportive Counseling|"NT is a procedure in which the therapist refrains from directing the client, but instead reflects back to the client what the latter has said. NT is chosen for this study to control for non-specific effects that show to contribute to outcome such as therapeutic alliance and therapist competency.
~The protocol for the individualized NT will mirror the layout of IM therapy -12 weekly meetings, 30 minutes each. Subjects in NT group will be instructed to do Diaphragmatic Breathing (DB) exercise and will be given assigned homework (writing journal) and track progress. DB is incorporated into the NT as treatment providing non-specific effects associated with attention and homework completion."
16223578|NCT01211405|Drug|Low dose MDMA|30 mg MDMA administered p.o. once during each experimental session. Upon mutual agreement this maybe followed by a supplemental dose of 15 mg MDMA 1.5 to 2 hours later
16223579|NCT01211405|Drug|Medium dose MDMA|75 mg MDMA adminis5tered p.o. once at start of an experimental session. Upon mutual agreement, may be followed 1.5 to 2 hours later by a supplemental dose of 37.5 mg
16223580|NCT01211405|Drug|Full dose MDMA|125 mg MDMA administered p.o. at start of an experimental session. By mutual agreement, may be followed 1.5 to 2 hours later by a supplemental dose of 62.5 mg MDMA.
16223581|NCT01211405|Behavioral|Psychotherapy|Psychotherapy throughout main study
16223582|NCT01211392|Other|magnetic resonance imaging|magnetic resonance imaging is compared to dual-energy computed tomography for the detection of bone marrow changes
16223583|NCT01211379|Behavioral|FLU-FOBT Program|Primary care patients who came in for flu shots were assessed by nurses for colorectal cancer screening eligibility and offered FOBT if due.
16223584|NCT01211366|Other|Cell Saver RBCs|Use of cell saver RBCs to decrease the infusion of allogeneic PRBCs, crystalloid, and colloid in post-operative infants following CPB as needed for hemodynamic instability
16223585|NCT01211366|Other|Conventional volume infusion|Infusion of allogeneic PRBCs, crystalloid, and colloid as needed for hemodynamic instability
16223586|NCT01211353|Behavioral|Personalized Drinking Feedback|Personalized feedback about one's drinking habits
16223587|NCT01211353|Behavioral|Education-Only|Educational information about alcohol use
16223588|NCT01211340|Behavioral|ACTIVE|Assessing Caregivers for Team Intervention via Video Encounters: this intervention uses video technology to bridge geographic distance to empower hospice caregivers to participate in plan of care meetings for their patient
16223589|NCT01211327|Drug|Cyclosporine A|Cyclosporine 2% eye drops
16223590|NCT01211327|Drug|Dexamethasone|Dexamethasone 0,1% eye drops
16223591|NCT01211314|Drug|Lercanidipine/enalapril fixed combination|Lercanidipine 10 mg + enalapril 20 mg, once a day, used as a fixed combination drug. Unique dose during the study
16223592|NCT01211301|Behavioral|Food-based, Reduced Energy Diet Plan|Control participants will be provided with a 1000-kcal/d meal plan based on regular foods selected and procured by participants. Food lists, sample menus, and portion size references will be provided.
16223593|NCT01211301|Other|Medifast 5 & 1 Plan|Participants randomized to the Medifast group will enroll online in the Medifast 5 & 1 Plan. This plan consists of 5 portion-controlled, nutritionally-balanced Medifast Meals plus one Lean & Green Meal each day. Medifast Meals come in individual packets that are mixed with water and microwaved or refrigerated, and are available in a wide variety of foods and flavors. There are >70 Medifast Meal choices, and Medifast Meals may be used interchangeably, so any five Medifast Meals can be chosen for the 5 & 1 Plan. The Medifast 5 & 1 Plan provides approximately 800 to 1,000 kcal/d. The Lean & Green Meal consists of a lean meat plus salad and/or vegetables selected by the participant. Intervention participants will have online access to Medifast dietitians, Medifast trainers, a Medifast message board, and a Medifast chat room, allowing them to interact with others on the Medifast 5 & 1 Plan.
16223594|NCT01211288|Device|Astra implants|Root form OsseoSpeed TX Astra Tech Implant System
16223595|NCT01211275|Biological|axitinib|axitinib: 5 mg BID, day 2 until day 21 of each cycle; cisplatin: 75 mg/m2 day 1, every 3 weeks; pemetrexed: 500 mg/m2 day 1, every 3 weeks.
16223596|NCT01211275|Drug|chemotherapy|cisplatin: 75 mg/m2 day 1, every 3 weeks; pemetrexed: 500 mg/m2 day 1, every 3 weeks.
16223597|NCT01211262|Drug|IMCgp100|For each arm, the study will be divided into two parts: In part 1, dose escalation, the MTD or RP2D for each dosing regimen will be established. In part 2, dose expansion, a cohort of participants will be treated at the RP2D or MTD.
16223598|NCT01211249|Drug|GLPG0259 oral capsule|Two capsules, each containing 25 mg of GLPG0259 (i.e. 50 mg/day), to be given once daily; in case of adverse events the dose may be split over two administrations, or reduced to 25 mg/day (one single capsule)
16223599|NCT01211249|Drug|Placebo|Placebo capsules; two capsules to be taken in the morning, in case of adverse events the dose may be split over two administrations, or reduced to one single capsule
16223600|NCT01211249|Drug|GLPG0259 (Part B)|Capsule, dosage to be established based on results of Part A
16223601|NCT01211249|Drug|Placebo (Part B)|Capsules, dosage to be established after Part A, and matching GLPG0259 (Part B)
16223602|NCT01211236|Other|application of wound dressing made of bio-bags (vitapads) containing maggots|
16223603|NCT01211236|Other|application of classical hydrogel/alginate wound dressing|
16223604|NCT01211223|Drug|Administration of Metronidazole plus Amoxicillin|Metronidazole plus Amoxicillin after, during and after root planning
16223605|NCT01211210|Drug|fluorouracil|Drug: fluorouracil Given IV continuously Radiation: radiation therapy Given 5 days a week for 5-6 weeks
16223606|NCT01211210|Drug|fluorouracil, oxaliplatin|Drug: fluorouracil Given IV continuously Drug: oxaliplatin Given IV Radiation: radiation therapy Given 5 days a week for 5-6 weeks
16223607|NCT01211210|Drug|fluorouracil, oxaliplatin|Drug: fluorouracil Given IV continuously Drug: oxaliplatin Given IV
16223608|NCT01211197|Drug|C: BI 10773 / metformin tablet|BI 10773 / metformin fixed dose combination tablet after a high fat, high caloric meal
16223609|NCT01211197|Drug|B: BI 10773 tablet and metformin tablet|BI 10773 and metformin single tablets, administered together in fasted state
16223610|NCT01211197|Drug|A: BI 10773 / metformin tablet|BI 10773 / metformin fixed dose combination tablet in fasted state
16223611|NCT01211184|Dietary Supplement|Water administration|patients undergo hip surgery after receiving 800 ml water by mouth in the morning before the surgery.
16223612|NCT01211184|Dietary Supplement|carbohydrate drink|800 ml carbohydrate drink by mouth the evening before surgery and 400 ml carbohydrate drink by mouth 2 hours before surgery
16223613|NCT01211184|Behavioral|Fasting.|The patient is fasting from midnight before the surgery.
16223614|NCT01211171|Drug|Telmisartan (Kinzal/Pritor, BAY68-9291)|Patients treated with telmisartan tablets under the real-life setting. Dosing regimen customised to the needs of each participating patient according to the investigators assessment
16223615|NCT01211158|Drug|Ketofol|Syringes containing ketofol (mixed propofol-ketamine) will contain propofol 5mg/ml and ketamine 5 mg/ml. Patients will receive an initial intravenous dose of 0.075 millilitres per kilogram of pre-prepared medication. Patients in the propofol-ketamine group will receive 0.375 mg/kg each of ketamine and propofol as an initial bolus and 0.188 mg/kg each of ketamine and propofol as necessary until reaching deep sedation (Ramsay score = 5 or greater).
16223616|NCT01211158|Drug|Propofol alone|Propofol-only syringes will contain propofol 10 mg/ml. Patients in each group will receive an initial intravenous dose of 0.075 millilitres per kilogram of pre-prepared medication (0.75 mg/kg). One minute after the initial dose of sedative, and every minute thereafter, the attending physician will assess the patient's level of sedation using the Ramsay Sedation Scale (RSS). If the attending physician determines the level of sedation to be inadequate (RSS<5), additional study drug will be administered at a dose of 0.0375 millilitres per kilogram (0.375 mg/kg) every minute until deep sedation is achieved (RSS=5 or greater).
16223617|NCT01211145|Drug|Placebo|Placebo nasal spray
16223618|NCT01211145|Drug|Zolmitriptan|0.5 mg nasal spray
16223619|NCT01211145|Drug|Zolmitriptan|2.5 mg nasal spray
16223620|NCT01211145|Drug|Zolmitriptan|5.0 mg nasal spray
16223621|NCT01211132|Device|Cap - Transparent retractable extension device.|Attaching a Cap - Transparent retractable extension device.
16223622|NCT01211132|Device|Standard|Without attaching a transparent cap to the tip of colonoscope.
16223623|NCT01211119|Other|No PRF|Group B (n=6), implantation of PRF after partial menisectomy and suture; Group (n=6), partial menisectomy only
16223624|NCT01211106|Behavioral|Prolonged Exposure|Although almost every form of psychotherapy has been advocated for PTSD, all evidence-based psychotherapies for PTSD are CBT programs that include variants of exposure therapy (Prolonged Exposure), cognitive therapy (CT), stress inoculation training (SIT), eye movement desensitization and reprocessing (EMDR), or combinations of these procedures. Exposure therapy involves helping PTSD sufferers to gradually confront distressing trauma-related memories and reminders to facilitate successful emotional processing of the trauma memory and reduction of associated distress. Most exposure therapy programs include both imaginable confrontation with the traumatic memories and in vivo exposure to trauma reminders.
16223625|NCT01211106|Behavioral|Motivational Enhancement Therapy|Motivational Interviewing (MI) is defined as a client-centered, directive method for enhancing intrinsic motivation to change by exploring and resolving ambivalence. MI is characterized by its spirit, which is defined as collaboration with the client, evocation of the client's own perceptions, goals, and values, and respect for the client's autonomy.
16223626|NCT01211093|Procedure|High frequency whole body vibration|1 single session (10 minutes) of whole body vibration therapy at 30 Hz
16223627|NCT01211093|Procedure|Low frequency whole body vibration|1 single session of whole body vibration therapy at 20 Hz
16223628|NCT01211093|Procedure|control|1 single session of standing on the vibration platform, with no vibration signals delivered.
16223629|NCT01211080|Drug|Propranolol|Propranolol 2mg/kg/day divided to three oral doses with or without concomitant physical therapy (cryotherapy, laser)
16223630|NCT01211067|Procedure|Lichtenstein hernioplasty|"Mesh hernioplasty
~Ultrapro mesh (Ethicon, Johnson & Johnson)"
16223631|NCT01211028|Biological|Expanded autologous ASCs|Drug: Expanded autologous adipose-derived adult stroma/stem cells
16223632|NCT01211002|Radiation|radiotherapy combined with EP|Tumor vo lume is 60-66 Gy / 30-33f and the combination regimen is etoposide (50 mg/m2 day1-5, 29-33) and cisplatin (50 mg/m2 day1, 8, 29, 36) in the 1st, 4th weeks of radiotherapy for 2 courses.
16223633|NCT01211002|Drug|radiotherapy / EP combined with recombinant human endostatin|Anti-vascular targeting therapy The number of courses is 3 ~ 4 and each course last for 28 days. Recombinant human endostatin（Endostar）：15mg，d1-14, intravenous injection.
16223634|NCT01210989|Drug|Phyllanthus urinaria|Subjects meeting the inclusion and exclusion criteria will be randomized (2:1) to receive oral Hepaguard 1 g three times daily or placebo of identical appearance. At week 24, subjects receiving active Hepaguard will be randomized (1:1) to continue Hepaguard for another 24 weeks or stop treatment.
16223635|NCT01210989|Drug|Placebo|Subjects meeting the inclusion and exclusion criteria will be randomized (2:1) to receive oral Hepaguard 1 g three times daily or placebo of identical appearance.
16223636|NCT01210976|Drug|levosimendan|12 mcg/kg/10min bolus and 24 hour infusion at a rate of 0.2 mcg/kg/min
16223637|NCT01210976|Drug|placebo|nacl 0.9% coloured with thiamin in same volume and time than levosimendan
16223638|NCT01210963|Device|SENSIMED Triggerfish|Contact lens-based Sensor with recording system for continuous monitoring of IOP fluctuation
16223639|NCT01210950|Biological|cell and RPR injection|mesenchymal cells and Plasma reach Protein are injected to the callus center
16223640|NCT01210937|Procedure|CEA and TCD monitoring|All patients will receive carotid endarterectomy. During the surgery, all of them will be monitored by TCD. Record the blood flow velocity and blood pressure on specified time.
16223641|NCT01210911|Drug|gemcitabine|Gemcitabine at a dose of 1000 mg/m2 (iv, 30 minutes) will be given weekly, for 3 weeks, followed by one week without gemcitabine
16223642|NCT01210911|Drug|erlotinib|Erlotinib will be administered at a daily dose of 100 mg at least one hour before or 2 hours after the ingestion of food
16223643|NCT01210911|Drug|metformin|Metformin will be administered at a dose of 500 mg twice daily for the first week. If tolerated well, the dose will be increased up to 1000 mg twice daily in the second week.
16223644|NCT01210911|Drug|placebo|Placebo will be administered at a dose of 500 mg twice daily for the first week. If tolerated well, the dose will be increased up to 1000 mg twice daily in the second week.
16223645|NCT01210898|Biological|Adjuvanted seasonal influenza vaccine|Full or half dose of adjuvanted seasonal influenza vaccine; Full or half dose of unadjuvanted seasonal influenza vaccine
16223646|NCT01210885|Biological|Meningococcal Vaccine|MenABCWY combination vaccine containing four different rMenB formulations with MenACWY, intramuscular (IM) administration, vaccination at 0 and 2 months.
16223647|NCT01210872|Other|questionnaire administration|
16223648|NCT01210872|Procedure|quality-of-life assessment|
16223649|NCT01210872|Procedure|standard follow-up care|
16223650|NCT01210846|Drug|tivozanib|1 x 1.5 mg capsule of tivozanib orally once daily for 21 days
16223651|NCT01210833|Device|HandTutor System|Computerized system designed to evaluate and rehabilitate hand function. It is composed of a glove with special sensors detecting the movements of the wrist and the fingers, with a biofeedback software designed to evaluate and then to exercise the hand movements through supplying a variety of computer graphic patterns.
16223652|NCT01210820|Device|iFS™ Femtosecond Laser System|intrastromal arcuate cuts made with iFS™ femtosecond laser
16223653|NCT01210807|Device|One-Piece Tecnis Multifocal IOL|One-piece Tecnis Multifocal IOL, Model ZMB00, implanted lens.
16223654|NCT01210807|Device|One-Piece Tecnis monofocal IOL, Model ZCB00|Control lens: One-Piece Tecnis monofocal IOL, Model, ZCB00, implanted lens.
16223655|NCT01210781|Procedure|deep brain stimulation (DBS)|deep brain stimulation (DBS) is in itself not part of this study but a clinical indication. The study aims at documenting DBS parameters and outcome
16223656|NCT01210768|Drug|Epirubicin+Cyclophosphamide|Cyclophosphamide 600 mg/m2 infusion followed by epirubicin 90 mg/m2 infusion on Day 1 in each 21-day treatment cycle. Treatment will be repeated for 4 cycles in the EC arm.
16223657|NCT01210768|Drug|liposomal-doxorubicin+Cyclophosphamide|Cyclophosphamide 600 mg/m2 infusion followed by pegylated liposomal-doxorubicin 37.5mg/m2 infusion on Day 1 in each 21-day treatment cycle. Treatment will be repeated for 5 cycles in the LC arm.
16223658|NCT01210755|Drug|Rivaroxaban, Dabigatran|Rivaroxaban: One dose of 20mg (2 tablets of 10mg) then Dabigatran: One dose of 150mg(2 capsules of 75mg) two weeks later
16223659|NCT01210755|Drug|Dabigatran; Rivaroxaban|Dabigatran: One dose of 150mg(2 capsules of 75mg) then Rivaroxaban: One dose of 20mg (2 tablets of 10mg)two weeks later
16223660|NCT01210742|Device|Synvisc One|Single intra-articular injection of a 6 mL of Hylan G-F 20 at baseline
16223661|NCT01210742|Other|Routine management|Routine non-operative management for knee OA (NICE guidelines)
16223662|NCT01210729|Device|Solitaire FR, ev3|Placement of the stent in the occluded vessel segment, withdrawal in its unfolded state.
16223663|NCT01210716|Device|Therapeutic plasma exchange|Patients are randomized to either Therapeutic plasma exchange procedures on AMICUS or Spectra first. The second procedure (based on time interval determined by physician) will be completed on the other instrument.
16223664|NCT01210677|Drug|Prednisone|Prednisone 0.5 mg/Kg orally per day for 3 months
16223665|NCT01210664|Biological|Ex vivo Expanded Human Autologous Polyclonal Regulatory T Cells|The researchers will multiply/expand the Tregs in the laboratory using anti-CD3/anti-CD28 coated beads plus IL-2. Then, the Tregs will be infused back into the patient in a single infusion. The first cohort will receive 0.05 x10^8 cells. The second cohort will receive 0.4 x10^8 cells. The third cohort will receive 3.2 x10^8 cells. The fourth cohort will receive 26 x10^8 cells.
16223666|NCT01210651|Behavioral|Hatha Yoga Practice Group|The hatha yoga intervention was a sequence of classical yoga practices, comprised of breathing techniques, mindful body postures, and a final deep relaxation pose. The same sequence was used in all sessions. Yoga practices were broken down into component elements and taught progressively to each student in accordance with his or her ability. Participants were encouraged to remain within their range of motion or comfort. Accommodations were made for those with limitations in tolerance or flexibility for any exercise. Blocks, bolsters and other props were used to support participants in learning and holding yoga poses safely, particularly during back-bends or inverted poses. The intervention was delivered by a licensed, registered nurse, who was also a registered yoga teacher.
16223667|NCT01210651|Behavioral|Attention Control Education Group|The educational seminars taught to participants covered the history and philosophy of the main branches of yoga. Documentary films were used during the seminars to enhance lectures, and interactive dialogue was encouraged between instructor and participants. Seminars were designed to control for non-specific mood benefits of study participation, such as attention from instructors, peer interaction, time spent away from routine activities, and anticipation/interest related to mastering novel yoga-related information. Since participants would join the attention control group on a rolling basis, seminars were designed to function as stand-alone educational modules, rather than requiring presentation in a specific sequence. The instructor for the seminars was a registered yoga teacher.
16223668|NCT01210638|Drug|Oxymorphone|10 mg tablet
16223669|NCT01210625|Dietary Supplement|Nutrabiotix|Fiber supplement: 9mg or 12mg
16223670|NCT01210625|Dietary Supplement|Psyllium|12g total per day (4 capsules containing 1 gram psyllium fiber 3 times a day)
16223671|NCT01210612|Device|five-toed socks|five-toed socks usage
16223672|NCT01210599|Drug|Pamidronate|The study was a randomized, double blind, dose-escalation trial of IV pamidronate. Study participants were divided among four study phases. Each group received IV placebo or escalating doses of IV pamidronate of 30mg, 60mg, 90mg and 180mg.
16223673|NCT01210586|Behavioral|Part 2|Comparing smoking symptomatology by HRT and nicotine patch status using a 2x2 randomized design.
16223674|NCT01210573|Device|adjustment of LVAD or pacemaker|"For patients without a device: Patients start at rest for 2 minutes and will wear a face mask and breathing parameters are recorded using the SHAPE-HF system (SHAPE Medical St. Paul, MN) that measures respiratory airflow and the constituent respiratory gases, oxygen and carbon dioxide.
~For patients with a device: patients will be at rest and the adjustments of their device will be made by a study physician or device coordinator, done routinely in clinical practice. This will take up to 15 minutes and during this time; participants will wear a face mask and breathing parameters are recorded using the SHAPE-HF system (SHAPE Medical St. Paul, MN) that measures respiratory airflow and the constituent respiratory gases, oxygen and carbon dioxide."
16223675|NCT01210560|Drug|Tolvaptan MR|20 mg Tolvaptan MR capsule(morning); Placebo capsules/tablets (morning and afternoon) for 7 days
16223676|NCT01210560|Drug|Tolvaptan MR|20 mg Tolvaptan MR capsule(morning and afternoon); Placebo capsules/tablets (morning and afternoon) for 7 days
16223677|NCT01210560|Drug|Tolvaptan MR|60 mg Tolvaptan MR capsule(morning); Placebo capsules/tablets (morning and afternoon) for 7 days
16223678|NCT01210560|Drug|Tolvaptan IR|90 mg Tolvaptan IR tablet(morning); 30 mg Tolvaptan IR tablet (afternoon); Placebo capsules (morning and afternoon) for 7 days
16223679|NCT01210560|Drug|Tolvaptan MR|120 mg Tolvaptan MR capsule(morning); Placebo capsules/tablets (morning and afternoon) for 7 days
16223680|NCT01210534|Other|No intervention|No intervention
16223681|NCT01210521|Drug|Vitamin D|Vitamin D, (2000IU) will be administered orally, once a day, for one month.
16223682|NCT01210495|Drug|Axitinib (AG-013736)|Axitinib [tablet, 1 mg, 5 mg] will be given twice daily [BID] with continuous dosing; duration is approximately 3-6 months; starting dose is 5 mg BID
16223683|NCT01210495|Other|Best Supportive Care|BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life.
16223684|NCT01210495|Drug|Placebo|Placebo [tablet, 1 mg, 5 mg] will be given twice daily [BID] with continuous dosing; duration is approximately 3-6 months; starting dose is 5 mg BID
16223685|NCT01210495|Other|Best Supportive Care|BSC may include medications and supportive measures deemed necessary to palliate disease related symptoms and improve quality of life.
16223686|NCT01210482|Drug|Temsirolimus|The usual adult dosage is temsirolimus 25 mg once weekly, to be administered via gradual intravenous infusion over 30~60 minutes. The dosage is to be appropriately reduced according to patients' status.
16223687|NCT01210469|Other|Strengthening and balance exercises|The group trained for 8 weeks, with sessions of about 60 minutes, twice a week.
16223688|NCT01210469|Other|Stretching and balance exercises|The group trained for 8 weeks, with sessions of about 60 minutes, twice a week.
16223689|NCT01210456|Drug|Physiological Saline, N-Acetylcysteine and Sodium Bicarbonate|"All patients receive N-Acetylcysteine(NAC) and sodium chloride. NAC is given orally at a dose of 700mg twice daily, on the day before and on the day of administration of the contrast media, for a total of two days.
~154mEq/L of sodium chloride is given intravenously. The initial intravenous bolus is 3ml/kg per hour for 1 hour immediately before contrast injection. And then, patients receive the same fluid at 1ml/kg per hour during the contrast exposure and for 6 hours after the procedure.
~In addition, intervention arms receive sodium bicarbonate.1000mEq/L of sodium bicarbonate is given intravenously twice at a dose of 40ml immediately before the contrast exposure and immediately after the procedure."
16223690|NCT01210443|Drug|Sitaxentan|sitaxentan sodium 100 mg
16223691|NCT01210430|Drug|Losartan|Subjects will receive placebo or losartan for 4 weeks. Days 1-7, subjects will receive 12.5mg of Losartan or placebo. Days 7-14, subjects will receive 25mg of Losartan or placebo. Days 14-28, subjects will receive 50mg of Losartan or placebo.
16223692|NCT01210430|Drug|Ascorbic Acid (Vitamin C)|Subjects will receive 60mg/kg of Ascorbic Acid over 20 minutes followed by a maintenance infusion of 20mg/kg.
16223693|NCT01210430|Drug|Normal Saline|Subjects will receive 60mg/kg of normal saline over 20 minutes followed by a maintenance infusion of 20mg/kg of normal saline.
16223694|NCT01210417|Other|Non invasive monitoring|Three-lead electrocardiogram (ECG), PPG oxymetry, non-invasive blood pressure (NIBP) are registered
16223695|NCT01210404|Drug|filibuvir|Filibuvir, 600mg bid administered along with methadone on days 2-11
16223696|NCT01210391|Other|Extensively hydrolyzed whey infant formula|New hydrolyzed infant formula.
16223697|NCT01210391|Other|Extensively hydrolyzed casein infant formula|Commercially available infant formula.
16223698|NCT01210378|Drug|Nitroglycerin patch|Nitroglycerin patch
16223699|NCT01210365|Drug|Diurisa®|Furosemide 40 mg + amiloride chloride 10 mg.The patient will swallow onde tablet per day in whole form on an empty stomach with some liquid during 4 weeks.
16223700|NCT01210365|Drug|Lasix ®|One group of patients will receive furosemide 40mg .The patient will swallow the tablet in whole form on an empty stomach with some liquid.
16223701|NCT01210352|Drug|oxymorphone HCl|Comparison of different dosages of drug, 0.05mg/kg, 0.10mg/kg, 0.15mg/kg or 0.20mg/kg oral liquid oxymorphone
16223702|NCT01210339|Drug|Clopidogrel|Clopidogrel
16223703|NCT01210339|Drug|Esomeprazole/ASA|20 mg/81 mg once daily for five days (Day 5-9)
16223704|NCT01210326|Procedure|extaction|TESE (testicular sperm extraction), which is actually a surgical biopsy of the testis; or TESA (testicular sperm aspiration), which is performed by sticking a needle in the testis and aspirating fluid and tissue with negative pressure
16223705|NCT01210326|Procedure|testicular sperm extraction|testicular sperm extraction
16223706|NCT01210326|Procedure|testicular sperm aspiration|testicular sperm aspiration
16223707|NCT01210287|Drug|nucleoside analog reverse transcriptase inhibitor|tablets 100mg qd
16223708|NCT01210261|Device|Compumedics Somnilink SPAP - Auto-titrating CPAP|"Subjects will undergo the auto-titrating CPAP treatments in the Monash Sleep Centre with the test and reference devices during two nights in random order. There will be an interval of at least seven days between the two treatments to eliminate the carryover effect.
~Full polysomnographic (PSG) recording will be conducted during both treatment nights. The recorded physiological signals during PSG will include signals identical to those used during the baseline diagnostic PSG. The patients fill KSS questionnaire immediately after the PSG study.
~All PSG recordings (both treatment studies and the baseline diagnostic study) will be scored according to the AASM rules by the same sleep technician blinded to the presence and type of auto-titrating CPAP treatment."
16223709|NCT01210261|Device|Resmed Autoset S8 - Auto-titrating CPAP|"Subjects will undergo the auto-titrating CPAP treatments in the Monash Sleep Centre with the test and reference devices during two nights in random order. There will be an interval of at least seven days between the two treatments to eliminate the carry-over effect.
~Full polysomnographic (PSG) recording will be conducted during both treatment nights. The recorded physiological signals during PSG will include signals identical to those used during the baseline diagnostic PSG. The patients fill KSS questionnaire immediately after the PSG study.
~All PSG recordings (both treatment studies and the baseline diagnostic study) will be scored according to the AASM rules by the same sleep technician blinded to the presence and type of auto-titrating CPAP treatment."
16223710|NCT01210248|Other|BLOOD COLLECTION|BLOOD SAMPLE WILL BE COLLECTED FOR 3 KINDS OF TESTS
16223711|NCT01210235|Behavioral|FLU-FIT Program|In the intervention, eligible patients aged 50-75 who come in for flu shots and are due for colorectal cancer screening will be offered FIT.
16223712|NCT01210222|Biological|Trebananib|Given IV
16223713|NCT01210209|Other|genome-wide association study|
16223714|NCT01210196|Procedure|MRI|Cardiac MRI after 12 and 24 months.
16223715|NCT01210183|Drug|Dextrose intraarticularly administered|9 ml of 12.5% dextrose
16223716|NCT01210170|Drug|placebo|placebo inhalation before albuterol.
16223717|NCT01210170|Drug|mometasone 400 mcg|mometasone inhalation before albuterol.
16223718|NCT01210170|Drug|mometasone 200 mcg|200ug mometasone before albuterol.
16223719|NCT01210144|Drug|Gonal -f® [r-hFSH]|On Day 2 of the menstrual cycle, a pre-defined fixed dose of 150 International Units (IU) per day of recombinant human follicle stimulating hormone (r-hFSH) will be administered until follicles are recruited and developed.
16223720|NCT01210144|Drug|Ovitrelle® [r-hCG alfa]|Ovulation triggering will be performed using a single injection of 250 microgram (mcg) recombinant human chorionic gonadotropin (r-hCG) alfa as soon as follicles satisfy the criteria for follicular development, that is at least 3 follicles greater than (>) 16 millimeter (mm), and with estradiol (E2) > 1 microgram per liter (mcg/L) if gonadotropin releasing hormone (GnRH) agonist will be used.
16223721|NCT01210144|Drug|Gonadotropin-releasing hormone (GnRH) Agonist|To prevent premature ovulation in participants undergoing a controlled ovarian stimulation (COS), 0.1 milligram (mg) GnRH agonist daily will be given after endometrial biopsy, 7 days after the peak day of luteinizing hormone (Day LH + 7) as per summary of product characteristics (SmPC), in long agonist protocol.
16223722|NCT01210144|Drug|Gonadotropin-releasing hormone (GnRH) Antagonist|To prevent premature ovulation in participants undergoing a COS, 0.25 mg GnRH antagonist daily will be given from Day 6 of Gonal-f® stimulation treatment as per SmPC, in multi-dose antagonist protocol.
16223723|NCT01210131|Drug|[18F]HX4|Intravenous injection
16223724|NCT01210118|Behavioral|Low intensity intervention|Control group participants received a face to face low intensity intervention which lasted 5 minutes and included brief advice and the provision of a leaflet on smoking and pregnancy. This leaflet summarized the main effects of smoking during pregnancy and gave clear short messages for encouraging smoking cessation by setting up a quit date.
16223725|NCT01210118|Behavioral|Higher intensity intervention|"Experimental group participants received a higher intensity intervention, which include: 30 minutes of individualized cognitive-behavioural counselling delivered by a trained health care professional and a self-help manual especially tailored for smoking cessation during pregnancy. Counseling was based at the 5 Αs (Ask,Advise, Asses, Assist, Arrange). In addition to counselling, a self help manual especially tailored for smoking cessation during pregnancy for Greek women was provided."
16223726|NCT01210079|Drug|Gabapentin;|Gabapentin titrated to daily dose of 2400mg PO over 1 week with established dose taken daily for 5 weeks.
16223727|NCT01210079|Drug|Placebo|Placebo titrated over 1 week with established dose taken daily for 5 weeks.
16223728|NCT01210066|Drug|Fentanyl|IV fentanyl 1mcg/kg
16223729|NCT01210066|Other|Cold pressor test|Non-dominant arm submerged in ice water (0 degrees Celsius) until it is no longer tolerable but less than 5 minutes
16223730|NCT01210066|Other|Fentanyl plus cold pressor test|fentanyl IV 1mcg/kg fifteen minutes prior to cold pressor test (arm submerged in ice water until no longer tolerable but no longer than 5 minutes)
16223731|NCT01210053|Drug|malate Given orally|Patients receive oral sunitinib malate 25 mg daily in the absence of disease progression or unacceptable toxicity.
16223732|NCT01210040|Dietary Supplement|Folic Acid|2.8mg
16223733|NCT01210040|Dietary Supplement|Folic Acid and Iron|60mg Iron and 2.8mg Folic Acid
16223734|NCT01210014|Drug|zinc sulphate 220mg/day in one dosage|"patients with clinical signs and symptoms of RAS , in whom clinical diagnosis was accompanied with low level of zinc serum were selected for the study. Gender, age, medical history, symptoms, types and site, number, size, pain level, intervals, disease duration and form of treatment were recorded for all participants. Patients were randomly divided into two groups . The case group (n=7) received a single dose of zinc sulphate in the form of 220 mg capsules for 1 month ,while starch-containing placebo was administered with the same dosage and period in the control group.
~The clinical data were scored according to the size of lesions were scored subjectively.
~the symptomatology score was obtained using a visual analogue scale(VAS). All participants in both groups were examined up to 5 months in order to assess the effectiveness of the treatment. At the end of fifth month the serum zinc level was tested again."
16223735|NCT01210014|Drug|placebo: one dosage|"patients with clinical signs and symptoms of RAS , in whom clinical diagnosis was accompanied with low level of zinc serum were selected for the study. Gender, age, medical history, symptoms, types and site, number, size, pain level, intervals, disease duration and form of treatment were recorded for all participants. Patients were randomly divided into two groups . The case group (n=7) received a single dose of zinc sulphate in the form of 220 mg capsules for 1 month ,while starch-containing placebo was administered with the same dosage and period in the control group.
~The clinical data were scored according to the size of lesions were scored subjectively.
~the symptomatology score was obtained using a visual analogue scale(VAS). All participants in both groups were examined up to 5 months in order to assess the effectiveness of the treatment. At the end of fifth month the serum zinc level was tested again."
16223736|NCT01210001|Drug|Placebo|Placebo tablets matching BI 10773 low dose
16223737|NCT01210001|Drug|BI 10773|BI 10773 tablets once daily
16223738|NCT01210001|Drug|Placebo|Placebo tablets matching BI 10773 high dose
16223739|NCT01210001|Drug|Placebo|Placebo tablets matching BI 10773 high dose
16223740|NCT01210001|Drug|Placebo|Placebo tablets matching BI 10773 high dose
16223741|NCT01210001|Drug|BI 10773|BI 10773 tablets once daily
16223742|NCT01209988|Drug|tamsulosin 0.4mg|perioperative tamsulosin 0.4mg daily for three weeks
16223743|NCT01209988|Other|No medication|No medication
16223744|NCT01209975|Procedure|Selective Laser Trabeculoplasty|Patient will have selective laser trabeculoplasty as the first treatment for glaucoma. This treatment will be dictated clinically, since we do not assign the interventions.
16223745|NCT01209949|Drug|Adapalene 0.1% and Benzoyl Peroxide 2.5% gel|Apply adapalene BPO gel once daily in the evening for 12 weeks
16223746|NCT01209936|Device|D2O|All participants received deuterium oxide (D2O) and testing with the BC3 for the measurement of total body water.
16223747|NCT01209923|Device|BC1|Body composition measures taken twice at the same visit for BIA, DEXA, and hydrostatic weighing.
16223748|NCT01209910|Other|Water|Subjects in this arm will be able to drink water with some conditions.
16223749|NCT01209897|Behavioral|Smoking cessation booklet|
16223750|NCT01209871|Biological|Autologous Lymphoma Immunoglobulin-derived scFv-chemokine DNA Vaccine|Given ID
16223751|NCT01209871|Other|Laboratory Biomarker Analysis|Correlative studies
16223752|NCT01209858|Drug|Perampanel and Microgynon-30|Part A: Microgynon-30 single oral dose on Day 1 Period 1 and Day 35 Period 2; perampanel oral daily dose starting at 4 mg per day Period 2 from Days 1 through 35 and titrated weekly.
16223753|NCT01209858|Drug|Perampanel and Microgynon-30|Part B: Perampanel single oral dose of 6 mg on Day 1 Period 1 and Day 21 Period 2; Microgynon-30 orally from Day 1 through Day 21 of Period 2.
16223754|NCT01209845|Drug|ketamine|intravenous ketamine(0.2 mg/kg) over 1-2 minutes IV
16223755|NCT01209832|Drug|Tasisulam|Patient specific dose, administered intravenously, on Day 1 of a 28-day cycle. Minimum of one (1) 28-day cycle. Patients may continue to receive tasisulam until disease progression or until discontinuation criteria are met.
16223756|NCT01209832|Drug|Midazolam|1.2 milligrams (mg), administered orally once prior to the initiation of tasisulam therapy and once on Day 8 after initiation of tasisulam therapy
16223757|NCT01209806|Drug|simethicone|400 mg simethicone at 6pm night prior to colonoscopy 400 mg simethicone 4 hours before colonoscopy
16223758|NCT01209793|Biological|REGN846|5 IV cohorts (Dose 1, 2, 3, 4, 5)
16223759|NCT01209780|Biological|TIV|Investigational egg-derived trivalent subunit influenza vaccine.
16223760|NCT01209780|Biological|TIVf|US licensed trivalent inactivated subunit influenza vaccine -Fluvirin (Novartis Vaccines and Diagnostics) is approved for use in subjects ≥4 years.
16223844|NCT01209221|Drug|RO5271983 - MAD|Once or twice daily doses of RO5271983 for 14 days
16223761|NCT01209780|Biological|Comparator TIV|US licensed trivalent subunit inactivated influenza vaccine- Fluzone (Sanofi Pasteur) is approved for use in children <4 years.
16223762|NCT01209767|Device|cryolipolysis|During cryolipolysis, the system drew fat tissue into an applicator then exposed the extracted fat tissue to cold temperatures. The cold exposure caused fat cells to die, with the goal to decrease the raised areas of cellulite
16223763|NCT01209767|Procedure|Subcision|Subcision was performed by inserting a specially designed needle under the skin after local numbing medication is injected. The needle is moved in a repetitive motion parallel to the skin to separate the surface tissue from the deeper scar tissue with the goal to improve the dimpling caused by these tissues sticking together.
16223764|NCT01209767|Other|Control|
16223765|NCT01209741|Drug|telcagepant potassium|[INTERVENTION NAME: MK-0974 12MoRT] Single dose MK-0974 12MoRT (12 month aged MK-0974 capsules, stored at room temperature) 300 mg in one of three treatment periods
16223766|NCT01209741|Drug|MK-0974 5Mo5C|Single dose MK-0974 5Mo5C (5 month aged MK-0974 capsules, stored at 5 Â°C) 300 mg in one of three treatment periods
16223767|NCT01209741|Drug|MK-0974 12Mo5C|Single dose MK-0974 12Mo5C (12 month aged MK-0974 capsules, stored at 5 Â°C) 300 mg in one of three treatment periods
16223768|NCT01209728|Other|Placebo/ethanol (blinded)|Elderly participants, including primary insomnia patients and healthy subjects will be administered i.v. ethanol or placebo in a blinded manner
16223769|NCT01209715|Drug|Placebo|participants will be assigned to 3-weeks treatment of inhaled placebo twice a day
16223770|NCT01209715|Drug|Fluticasone /salmeterol|Participant will be assigned to a 3-weeks treatment with inhaled fluticasone/salmeterol or matching placebo
16223771|NCT01209702|Biological|tocilizumab|Administered intravenously (iv) every 4 weeks
16223772|NCT01209702|Drug|Placebo|Placebo to tocilizumab administered intravenously every 4 weeks
16223773|NCT01209689|Drug|Tocilizumab|
16223774|NCT01209689|Drug|Placebo|
16223775|NCT01209676|Drug|IMCgp100 injection|a monoclonal T cell receptor anti-CD3scFv fusion protein
16223776|NCT01209663|Other|Postoperative Intermediate Care|Comparison of postoperative Intermediate Care versus Ward Care.
16223777|NCT01209650|Drug|BIBW 2992|tablets
16223778|NCT01209637|Behavioral|exercise training|exercise training min. 4 times a day for at least 30 min
16223779|NCT01209637|Behavioral|Intensive exercise training|Intensive exercise training for 4 times / day incl. interval training at 95% individual threshold
16223780|NCT01209611|Procedure|Autologous bone marrow mononuclear cells|Autologous bone marrow-derived mononuclear cells, after isolated by density gradient centrifugation from bone marrow aspiration and resuspended in saline, will be transplanted subcutaneously to expanded skin. The number of infused cells will be 1x10e6/cm2.
16223781|NCT01209611|Procedure|Placebo|Patients will have mimical bone marrow aspiration under local anesthesia following with saline injection to expanded skin.
16223782|NCT01209598|Drug|Palbociclib 200mg|Schedule 2/1: Palbociclib 200mg given once daily by mouth for 14 consecutive days, followed by 7 days of rest. A cycle will be defined as 21 days.
16223783|NCT01209598|Drug|Palbociclib 125mg|"Schedule 3/1: Palbociclib 125mg given once daily by mouth for 21 consecutive days, followed by 7 days of rest. A cycle will be defined as 28 days. Following the positive results of the study, a new Expansion Cohort has been added to permit enrollment of up to 20 additional patients.
~Expansion Cohort: Dosed as per Schedule 3/1. Capsules should be taken with food."
16223784|NCT01209585|Other|Blood samples|Subjects will have visits on Days 1, 30 and 120.
16223785|NCT01209585|Other|Synovial fluid aspiration|Subjects will have visits on Days 1, 30, and 120.
16223786|NCT01209585|Other|Synovial tissue sample|Subjects will have visits on Days 1, 30, and 120.
16223787|NCT01209572|Device|calorimetric chamber|Participants stayed 26h in a calorimetric chamber. They performed a series of physical activities such as walking on a treadmill at different speeds, writing, standing, standing-sitting, stepper , rest , sleeping and eating. They also performed a power test on an ergocycle at different speeds.
16223788|NCT01209572|Device|Free living conditions|Volunteers followed the protocol of doubly labeled water to evaluate their energy expenditure during 10 days in free living conditions. For this period, their heart rate, parameters of actimetry and other parameters were recorded.
16223789|NCT01209546|Other|control group|In placebo patients were assessed and were not subjected to any respiratory physical therapy technique.
16223790|NCT01209546|Other|Flutter group|Patients have done exercise sessions with Flutter ®VRP1 for 30 minutes daily in a randomized, crossover, with four weeks of treatment with a therapy, a week of wash-out followed by four more weeks with the other modality (PEP).
16223791|NCT01209546|Other|PEP group|Patients have done exercise sessions with Flutter® VRP1 without the steel ball inside, with the closure of so many holes as necessary to produce a positive expiratory pressure equivalent to pressure achieved by patients during the performance with the ball in the Flutter®VRP1 for 30 minutes daily in a randomized, crossover, with four weeks of treatment with a therapy, a week of wash-out followed by four more weeks with the other modality (Flutter®VRP1).
16223792|NCT01209546|Other|Group Sham|Patients have done exercise sessions with Flutter ®VRP1 for 30 minutes without the ball inside daily in a randomized, crossover, with four weeks of treatment with a therapy, a week of wash-out followed by four more weeks with the other modality (PEP)
16223793|NCT01209533|Drug|Iloprost|Inhaled iloprost 2.5 or 5 micrograms four times daily for 14 days
16223794|NCT01209520|Drug|Cisplatin|Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.
16223795|NCT01209520|Drug|Carboplatin|Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.
16223796|NCT01209520|Drug|Paclitaxel|Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.
16223797|NCT01209520|Drug|Vidaza|Patient will receive 5-azacitidine at a dose of 75 mg/m2 intravenously daily on day 1-5 every 28 days for 6 cycles
16224926|NCT01200784|Drug|Nicotinamide|dosage
16223798|NCT01209520|Procedure|Tumor Specimen for Methylation Analysis|Obtained from tissue of resected NSCLC tumor.
16223799|NCT01209520|Procedure|Blood Sample for Methylation Analysis|Pre-Surgery, Post-Surgery, Post-Vidaza Therapy and during follow-up.
16223800|NCT01209520|Drug|Vinorelbine|Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.
16223801|NCT01209520|Drug|Docetaxel|Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.
16223802|NCT01209520|Drug|Pemetrexed|Patients will receive a total of 4 cycles of adjuvant chemotherapy (each cycle given every 21 days). Conventional chemotherapy will be selected at discretion of the treating physicians except on those cases in which pathologic diagnosis indicates non squamous NSCLC.
16223803|NCT01209507|Other|Chemotherapy|This study is designed only to look at the prevalence of adrenal suppression during chemotherapy. If adrenal suppression is detected, treatment will be off-study at the treating physician's discretion.
16223804|NCT01209481|Behavioral|nutritional education group action|The educational group activities will consist of two-hour group dynamics and cooking workshops once a week and for five weeks.
16223805|NCT01209468|Device|monobloc oral appliance|one piece oral appliance
16223806|NCT01209468|Device|twinblock oral appliance|two-piece oral appliance
16223807|NCT01209455|Drug|Chlorphenamine and Ranitidine|We intend to use chlorphenamine (H1 antagonist) and ranitidine (H2 antagonist).Assuming NAC causes vasodilatation with an increase in forearm blood flow, we propose to administer 5 mcg/min to ensure maximal H1 blockade. In the presence of increased forearm blood flow, we propose to administer 37.5 mcg/min.
16223808|NCT01209455|Drug|Paracetamol|Therapeutic IV administration of 1g paracetamol results in a plasma concentration of ~12 mg/l. To achieve a desired concentration of ~25 mg/l, in the presence of a forearm blood blow of 50 ml/min, we would intend to administer an IA infusion of 1.25 mg/min. To account for the presence of increased forearm blood flow, we propose to administer 4 mg/min IA paracetamol.
16223809|NCT01209455|Drug|Paracetamol|To achieve a local paracetamol concentration of ~200 mg/l, a concentration comparable to potentially hepatotoxic concentrations following paracetamol overdose, we propose to administer 30 mg/min paracetamol.
16223810|NCT01209442|Drug|Bevacizumab|Bevacizumab will be administered at 10 mg/kg on day 1 and day 15. Four to six weeks following completion of concurrent IMRT, TMZ and bevacizumab, patients will receive 6 cycles of Bevacizumab.
16223811|NCT01209442|Drug|Temozolomide|Patients will be treated with hypofractionated IMRT (60 Gy in 10 Fx) and daily temozolomide at 75 mg/m2 qd concurrent with IMRT. Four to six weeks following completion of concurrent IMRT, TMZ and bevacizumab, temozolomide will be given at 150-200 mg/m2 qd on days 1-5 of each cycle.
16223812|NCT01209442|Radiation|RT (Radiation Therapy)|Patients will be treated with hypofractionated IMRT (60 Gy in 10 Fx)
16223813|NCT01209429|Drug|GH hormone infusion|Norditropin 30 ng/kg/min
16223814|NCT01209429|Behavioral|42 hour fast|The participant will be fasting 42 hours prior to the start of the study day, drinking water is allowed
16223815|NCT01209429|Behavioral|12 hour fast|12 hour fast will be used as a control scenario to 42 hour fast
16223816|NCT01209416|Drug|Acipimox|Tablet Acipimox 250 mg administered 4 times previous to and during the investigation day
16223817|NCT01209416|Drug|Ghrelin|Ghrelin infusion 4.2 ng/kg/min throughout the investigation day
16223818|NCT01209416|Other|Placebo|placebo tablets or saline infusion
16223819|NCT01209403|Drug|Glucose-infusion|Continuous iv infusion of glucose
16223820|NCT01209403|Drug|Glucose-insulin infusion|Continuous iv infusion of glucose and shortlasting
16223821|NCT01209390|Device|Chondromimetic|"The Chondromimetic implant is intended to serve as a scaffold for cellular and tissue ingrowth in osteochrondral defect repair such as bone and/or cartilage.
~The plug consists of a chondral layer with collagen and GAG and an osseus layer with collagen, GAG, and calcium phosphate."
16223822|NCT01209377|Behavioral|standard|EMDR treatment with bilateral stimulation via eye movement
16223823|NCT01209377|Behavioral|fixed|EMDR treatment with fixed eyes
16223824|NCT01209377|Behavioral|no focus|trauma exposure without external focus
16223825|NCT01209377|Procedure|EMDR|Eye Movement Desensitization and Reprocessing (EMDR)
16223826|NCT01209364|Device|Durolane is a device, methylprednisolone in a drug|single intraarticular injection
16223827|NCT01209351|Drug|Placebo|placebo
16223828|NCT01209351|Drug|teduglutide|teduglutide 4 mg
16223829|NCT01209338|Behavioral|Health education|Health education about HPV infection, HPV vaccine and cervix cancer.
16223830|NCT01209325|Biological|quadrivalent human papillomavirus (types 6, 11, 16, 18) recombinant vaccine|
16223831|NCT01209325|Other|laboratory biomarker analysis|
16223832|NCT01209312|Other|Bolus timing and dosing|We will be altering the timing and dosages of the prescribed meal bolus.
16223833|NCT01209299|Genetic|DNA methylation analysis|
16223834|NCT01209299|Genetic|gene expression analysis|
16223835|NCT01209299|Other|laboratory biomarker analysis|
16223836|NCT01209286|Biological|Blinatumomab|Continuous intravenous infusion over four weeks per treatment cycle
16223837|NCT01209260|Device|Radiofrequency energy needle|Radiofrequency energy needle for transseptal access
16223838|NCT01209260|Device|Mechanical Needle|Mechanical needle for transseptal access
16223839|NCT01209247|Other|Nasal, rectal and pharyngeal swabs|Nasal, rectal and pharyngeal swabs were performed before, during, and one month after the end of FQ treatment.
16223842|NCT01209221|Drug|Placebo - MAD|Once or twice daily doses of matching placebo to RO5271983 for 14 days
16223843|NCT01209221|Drug|Placebo - SAD|Single dose of matching placebo to RO5271983 for up to 3 periods
16223845|NCT01209221|Drug|RO5271983 - SAD|Single dose of RO5271983 at each period (for up to 3 periods)
16223846|NCT01209208|Drug|Budesonide|9 mg per day
16223847|NCT01209208|Drug|Mesalamine|3 g per day
16223848|NCT01209208|Other|Placebo|0 g per day
16223849|NCT01209195|Drug|MM-121|increasing doses of MM-121 IV QW
16223850|NCT01209195|Drug|Paclitaxel|Paclitaxel - 80 mg/m2 IV QW
16223851|NCT01209182|Device|Testing a new device (LS BioPath TOUCH) on excised tissue|Measurements are obtained with test device on excised tissue.
16223852|NCT01209156|Drug|[18F] PBR111|Subjects will be injected with 5mCi (not to exceed a maximum of 5.5 mCi) of [18F]PBR111, followed by PET imaging.
16223853|NCT01209143|Drug|Vismodegib|Vismodegib was supplied in hard gelatin capsules.
16223854|NCT01209143|Drug|Rosiglitazone|Rosiglitazone was supplied in tablets.
16223855|NCT01209143|Drug|Norethindrone/ethinyl estradiol|Norethindrone/ethinyl estradiol was supplied in tablets.
16223856|NCT01209130|Drug|DCDT2980S|Intravenous repeating dose
16223857|NCT01209130|Drug|rituximab|Intravenous repeating dose
16223858|NCT01209117|Drug|GSK2248761 WBM Capsule|200 mg GSK2248761 WBM capsule (reference) 2 X100mg
16223859|NCT01209117|Drug|GSK2248761 WBM Tablet Formulation 1|GSK2248761 WBM Tablet 200mg manufacturing process 1
16223860|NCT01209117|Drug|GSK2248761 WBM Tablet Formulation 2|GSK2248761 WBM Tablet 200mg manufacturing process 2
16223861|NCT01209117|Drug|GSK2248761 WBM Tablet Formulation 3|GSK2248761 WBM Tablet 200mg manufacturing process 3
16223862|NCT01209117|Drug|GSK2248761 WBM Tablet|GSK2248761 WBM tablet 200mg manufacturing process 1, 2, or 3 chosen from Period 1 - 4
16223863|NCT01209104|Drug|GSK1325756|100mg of a single oral dose of GSK1325756 administered as 2 x 50mg tablets
16223864|NCT01209104|Drug|GSK1325756|100mg of a single oral dose of GSK1325756 administered as 2 x 50mg tablets
16223865|NCT01209078|Drug|GSK1322322|GSK1322322 1500mg BID
16223866|NCT01209078|Drug|Linezolid|Linezolid 600mg
16223867|NCT01209078|Drug|GSK1322322 placebo|Placebo
16223868|NCT01209078|Drug|Linezolid placebo|placebo
16223869|NCT01209065|Drug|GSK1349572|GSK1349572 is an integrase inhibitor being developed for the treatment of human immunodeficiency virus -1 infection by ViiV Healthcare. This drug is experimental and has not been approved by the Food and Drug Administration (FDA).
16223870|NCT01209065|Drug|Fosamprenavir|Fosamprenavir is a drug in the protease inhibitor class that is approved by the FDA for the treatment of HIV infection.
16223871|NCT01209065|Drug|Ritonavir|Ritonavir is a drug in the protease inhibitor class that is approved by the FDA for the treatment of HIV infection.
16223872|NCT01209052|Drug|GSK1325756|Drug will be orally administered in varying amounts over varying time periods as detailed in the 'arms' section.
16223873|NCT01209052|Other|Placebo|Placebo will be orally administered to at least 4 subjects in each treatment period of each cohort. In each sequence in each cohort, all subjects will receive one dose of placebo.
16223874|NCT01209039|Drug|GSK1144814|Multiple daily doses of GSK1144814 for 28 days
16223875|NCT01209039|Drug|GSK1144814|Multiple daily doses of GSK1144814 for 14 days
16223876|NCT01209039|Drug|GSK1144814|Multiple daily doses of GSK1144814 for 7 days (or until steady state is reached)
16223877|NCT01209026|Drug|Fluticasone furoate (200 mcg)/GW642444 (25mcg) combination|Novel dry powder inhaler
16223878|NCT01209026|Drug|Fluticasone furoate (400 mcg)/GW642444 (50mcg) combination|Novel dry powder inhaler
16223879|NCT01209026|Drug|Placebo Inhaler|Matching placebo Novel dry powder inhaler. Lactose monohydrate and magnesium stearate.
16223880|NCT01209026|Drug|Moxifloxacin 400mg|Film coated oral tablet
16223881|NCT01209026|Drug|Moxifloxacin placebo|Film coated oral tablet
16223882|NCT01209013|Device|Medlight PDT Balloon|Medlight PDT Balloon will be used once to apply the laser light treatment
16223883|NCT01209013|Procedure|Endoscopy|Endoscopy will be performed to confirm eligibility, apply photodynamic therapy, assess esophageal condition and effectiveness of the therapy
16223884|NCT01209013|Procedure|Endoscopy with biopsy|Endoscopy with collection of esophageal tissue will be performed at screening to confirm eligibility and at Week 13 (final visit) to assess effectiveness
16223885|NCT01209013|Procedure|Electrocardiogram|Resting electrocardiogram will be performed at screening (unless one has been performed within 30 days prior to screening) to measure heart function
16223886|NCT01209013|Procedure|Chest x-ray|A chest X-ray will be performed at screening (unless one has been performed within 90 days prior to screening) to provide several pictures of the chest to rule out any lung abnormalities
16223887|NCT01209013|Procedure|Blood collection|Blood samples for laboratory tests will be taken to assess the overall condition
16223888|NCT01209013|Procedure|Tissue sample collection|Esophageal tissue samples will be collected before the porfimer sodium injection and on four separate occasions after the injection (22-26 hour-, 40-50 hour-, 96-120 hour-intervals, and 13 weeks) to measure concentrations of oligomers in a subgroup of 12 patients.
16223889|NCT01209000|Procedure|Kidney Biopsy|Patients scheduled to undergo a clinically indicated kidney biopsy will be requested to consent to an additional renal core, to be set aside until all clinical care is complete.
16223890|NCT01208987|Other|Medication History was printed|
16223891|NCT01208974|Procedure|Nipple-Sparing Mastectomy|Subcutaneous Mastectomy (SCM) to be performed, preserving the nipple and areola complex, after a frozen section of the tissue underneath the nipple-areola complex is sampled and found to be negative for tumor. Performed during Week 1.
16223892|NCT01208974|Procedure|Breast Reconstruction|Immediate reconstruction of the breast will be performed (after Nipple-Sparing Mastectomy) by the plastic surgeon, type depend on surgeon's discretion and patient's desire. Performed during Week 1.
16223893|NCT01208974|Procedure|Axillary Surgery|Axillary Dissection or Sentinel Node Biopsy (SNB) will be performed at surgeon's discretion.
16223894|NCT01208974|Radiation|Prophylactic Nipple-Areolar Complex RT|Prophylactic Nipple-Areolar Complex Radiation Therapy per protocol. Administered between weeks 5 to 8.
16223962|NCT01208428|Behavioral|Religious cognitive behavioral therapy|Religious cognitive behavioral therapy is conventional cognitive behavioral therapy that includes consideration of the patient's religious beliefs in therapy. Subjects will receive ten 50-min sessions of therapy
16224009|NCT01208155|Drug|Fostamatinib|Oral tablets, 100 mg Batch 1, single dose
16223895|NCT01208961|Drug|Epanova (4 g) and Lovaza (4 g)|Single dose of Epanova (omefas), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Epanova (omefas), 4x1g capsules, taken with high-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters, 4x1g capsules, taken with high-fat meals
16223896|NCT01208961|Drug|Lovaza (4 g) and Epanova (4 g)|Single dose of Lovaza (omega-3-acid ethyl esters), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Epanova (omefas), 4x1g capsules, taken with low-fat meals, 7 day washout followed by single dose of Lovaza (omega-3-acid ethyl esters,4x1g capsules, taken with high-fat meals, 7 day washout followed by single dose ofEpanova (omefas),4x1g capsules, taken with high-fat meals
16223897|NCT01208948|Drug|1,2 dithiolane 3 valeric acid|600 mg alpha lipoic acid per day
16223898|NCT01208935|Drug|Nicotine Patch|
16223899|NCT01208935|Drug|Nicotine Gum|
16223900|NCT01208922|Drug|Rifamycin SV-MMX®|2 Rifamycin SV-MMX® 200 mg tablets and 1 placebo to ciprofloxacin capsule, b.i.d.
16223901|NCT01208922|Drug|Ciprofloxacin|1 ciprofloxacin 500 mg capsule and 2 placebos to Rifamycin SV-MMX® 200 mg tablets, b.i.d.
16223902|NCT01208909|Procedure|diagnostic 5-ALA and MRI for tumor resection|diagnostic 5-ALA and MRI for tumor resection
16223903|NCT01208896|Drug|Reduced_intensity conditioning|The conditioning regimen is composed of Fludarabine (30 mg/m2) and Cyclophosphamide (750 mg/m2), both administered intravenously at Days -5, -4, -3 with Day 0 being the day of transplantation. Rituximab will be administered intravenously at 375 mg/m2 at Day -13 and 1000 mg/m2 at Days -6, +1, +8. Tacrolimus and low-doses of methotrexate will be used for prophylaxis of GVHD.
16223904|NCT01208883|Other|repetitive per-treatment [18F]FDG-PET for treatment adaptation|repetitive per-treatment [18F]FDG-PET for treatment adaptation
16223905|NCT01208870|Behavioral|Variety Group|The intervention will consist of our traditional family based weight control intervention with elements of reducing variety of high energy dense foods for the variety group.
16223906|NCT01208870|Behavioral|Nutrition Education Control|The intervention will consist of our traditional family based weight control intervention.
16223907|NCT01208831|Drug|LDE225|
16223908|NCT01208818|Drug|Cyclophosphamide + Bortezomib + Dexamethasone regimen|"Dosing regimen (21 day-cycle):
~Bortezomib 1.3 mg/m2 I.V. on days 1, 4, 8, and 11. An interval of at least 72 hours between each administration of bortezomib is required.
~Dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12.
~Cyclophosphamide 900 mg/m2 on day 1, through a short I.V. infusion The regimen is given for 3 cycles in the absence of serious side-effect."
16223909|NCT01208818|Drug|Bortezomib +Dexamethasone regimen|"Dosing regimen (21 day-cycle):
~Bortezomib 1.3 mg/m2 I.V. on days 1, 4, 8, and 11. An interval of at least 72 hours between each administration of bortezomib is required.
~Dexamethasone 20 mg on days 1, 2, 4, 5, 8, 9, 11 and 12. The regimen is given for 3 cycles in the absence of serious side-effect."
16223910|NCT01208818|Device|HCO group|TheraliteTM dialyzer of 2.1 m2 in surface
16223911|NCT01208818|Device|conventional high-flux dialyzer|conventional high-flux dialyzer; polyacrylonitrile, polysulfone, or PMMA dialysers, with an ultrafiltration coefficient > 14 ml/min and ≥ 1.8 m2 in surface, are recommended.
16223912|NCT01208805|Behavioral|Recording spinal cord evoked potentials|Recording spinal cord evoked potentials from patients suffering from intractable pain in whom epidural electrodes have already been implanted
16223913|NCT01208792|Procedure|skin biopsy|The biopsy site (usually the forearm) will be first cleaned, and then anesthetized with pain relieving (spray, cream, or injection). The skin is then sampled using a punch that takes a core (a small cylindrical fragment of tissue from the area of interest
16223914|NCT01208792|Other|Blood Sample|a blood sample will be collected
16223915|NCT01208766|Drug|Bortezomib, Melphalan, Prednisone (VMP)|"Bortezomib _ 1.3 mg/m2 _ i.v. rapid infusion _ days 1,4,8,11,22,25,29,32
~Melphalan _ 9 mg/m² _ p.o. _ days 1-4
~Prednisone _ 60 mg/m² _ p.o. _ days 1-4"
16223916|NCT01208766|Drug|1 or 2 cycle(s) HDM (High Dose Melphalan)|"- Melphalan _ 100 mg/m² _ i.v. rapid infusion _ -3, -2*
~*Patients with renal insufficiency 100 mg/m2 only at day -3
~If a patient is randomized to receive 2 x HDM a second course of High Dose Melphalan may be administered between 2 and 3 months after the first course when the patient achieved at least PR."
16223917|NCT01208766|Drug|2 cycles of Bortezomib, Lenalidomide, Dexamethasone (VRD)|"Bortezomib _ 1.3 mg/m2 _ i.v. rapid infusion _ days 1,4,8,11
~Lenalidomide _ 25 mg _ p.o. _ days 1-21
~Dexamethasone _ 20 mg _ p.o. _ days 1,2,4,5,8,9,11,12"
16223918|NCT01208753|Drug|GLPG0555|two different aqueous formulations
16223919|NCT01208753|Drug|GLPG0555 aqueous|multiple dose, aqueous formulation, 13 days, 100 mg/day once daily, maximum dose to be determined
16223920|NCT01208753|Drug|placebo|multiple dose, aqueous formulation, 13 days days, matching ascending dose schedule
16223921|NCT01208740|Drug|Metformin|500 mg three times daily
16223922|NCT01208740|Drug|Placebo|1 pill three times daily
16223923|NCT01208727|Procedure|postconditioning|Direct postconditioning (brief repeated cycle of 4 occlusion and desocclusion of the initially occluded culprit coronary artery) after primary direct stenting.
16223924|NCT01208714|Drug|Optimal medical therapy|"Optimal medical therapy, including optimal antihypertensive therapy as defined by ESH/ESC Guidelines Mancia G. J Hypertens 2007; 25: 1105), antiplatelet and, if necessary, hypolipemic and hypoglycemic treatment.
~All patients will receive antiplatelet treatment with the same dose of aspirin (100 mg o.d.) or ticlopidine (250 mg b.i.d) if intolerant ASA, or clopidogrel (75 mg o.d.), if intolerant to ASA and ticlopidine, throughout the study period. LDL-cholesterol will be lowered to below 100 mg/dl, homocysteine if elevated will be lowered and treatment for diabetes will be optimized (HbA1c < 6.5%)."
16223925|NCT01208714|Procedure|revascularization|The patients randomized to this treatment will undergo digital scan angiography (DSA) and PTA with stenting of the renal artery. PTA will be performed at the ostium or at truncular level. Stenoses involving more distal arterial vessels will be recorded and considered for data analysis but will not be treated. The patients randomized to revascularization will continue on their antihypertensive drug regimen. The dose and number of drugs will be down-titrated with the aim of pursuing the target BP values.
16223926|NCT01208701|Drug|Atorvastatin|Zarator, 80 mg pr day for 5 days
16223927|NCT01208701|Drug|Unikalk|1 tablet Unikalk pr day for 5 days
16223928|NCT01208688|Device|FES Therapy|Treatment group received functional electrical stimulation and control group received conventional occupational therapy.
16223929|NCT01208688|Device|FES Therapy|Subjects will be divided into one of two groups: a) subjects that will be trained with neuroprosthesis for grasping and b) the control group. The control group will be administered standard occupational therapies appropriate for recovery of grasping function in SCI subjects. In group a), neuroprosthesis for grasping will be used to train subjects to reach, grasp and manipulate various objects in the activities of daily living.
16223930|NCT01208688|Other|Conventional Occupational Therapy|The conventional therapy represents control activities against which FES therapy will be assessed. Conventional occupational therapy includes : a) muscle facilitation exercises emphasizing the neurodevelopmental treatment approach;b)task-specific repetitive functional training;c)strengthening and motor control training using resistance to available arm motion to increase strength; d)stretching exercises;e)electrical stimulation applied primarily for muscle strengthening (this is not FES); and f)activities of daily living including self care where the upper limb was used as an assist if appropriate; and caregiver training. Control and treatment group will have 3 sessions per week (business days only) for 13 to 16 weeks (40 treatment sessions in total). Each session will last 60 minutes.
16223931|NCT01208662|Drug|Lenalidomide|"Oral, 25 mg/day, days 1-14 for 8 total cycles for Arm A. Oral, 25 mg/day, days 1-14 for 5 total cycles for Arm B.
~Oral, 10-15 mg/day, daily for 12 months in maintenance for Arm A and Arm B."
16223932|NCT01208662|Drug|Bortezomib|IV, days 1, 4, 8 and 11 for 8 total cycles for Arm A. IV, days 1, 4, 8 and 11 for 5 total cycles for Arm B.
16223933|NCT01208662|Drug|Dexamethasone|"Oral, days 1, 2, 4, 5, 8, 9, 11 and 12 for 8 total cycles for Arm A. Oral, days 1, 2, 4, 5, 8, 9, 11 and 12 for 5 total cycles for Arm B.
~Dose of 20 mg/day for first 3 cycles. Dose of 10 mg/day for remaining cycles."
16223934|NCT01208662|Procedure|Autologous Stem Cell Transplant|Stem cell transplant
16223935|NCT01208649|Drug|Exenatide|Exenatide; 48 weeks 10 microg injection s.c., twice daily, before the morning and evening meal with a four week wash-in phase with 5 microg injection s.c.twice daily
16223936|NCT01208584|Other|fMRI, DTI|functional magnetic resonance imaging (fMRI), MR diffusion tensor imaging (DTI)
16223937|NCT01208571|Other|"Booster session"|Motivational interview
16223938|NCT01208558|Behavioral|Diet A|"Prudent diet without grains. Written advice and 17-20 group sessions. Subjects are advised to avoid cereal grains as much as possible. Apart from that, the recommendation is to follow Nordic Nutrition Recommendations (NNR) for overweight people (www.slv.se), i.e. to eat much fruit, vegetables, fish, and to choose low-fat meat, and low-fat dairy products, and to avoid candy, ice cream, snacks, cakes, pastries, chocolate, potato chips, beer, soft drinks and juice. In order to match carbohydrate intake between the intervention arms, a high intake of potatoes, root vegetables, fruit and other carbohydrate-rich foods is recommended.
~Guideline: 200-400 g of potatoes, 300-500 g of root crops, 400-600 g of vegetables, 200-300 g of beans, peas and corn, and 600 g of fruit and berries per day."
16223939|NCT01208558|Behavioral|Diet B|Prudent diet with whole grains. Written advice and 17-20 group sessions. An exchange of regular cereal grains for whole grains is recommended. A daily intake of 7-8 portions of whole grain products is recommended, and a list of recommended cereal products (brands, names) is provided. Apart from that, the recommendation is identical to Diet A: to follow Nordic Nutrition Recommendations (NNR) for overweight people (www.slv.se; in Swedish), i.e. to eat much fruit, vegetables, fish, and to choose low-fat meat, and low-fat dairy products, and to avoid candy, ice cream, snacks, cakes, pastries, chocolate, potato chips, beer, soft drinks and juice. The goal is that carbohydrate intake, as a proportion of total energy intake, should not differ between the groups.
16223940|NCT01208558|Behavioral|Physiotherapy|Twelve physiotherapy-led, charged, 2-hour sessions of structured group training for increased cardiorespiratory fitness. A pedometer sold at the start. Physical activity on prescription (FaR) at the end.
16223941|NCT01208506|Drug|NNC0114-0000-0005|A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects.
16223942|NCT01208506|Drug|NNC0114-0000-0005|A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects. Based on safety data, a single dose of NNC0114-0000-0005 may be administered i.v. (into the vein) in subjects with RA. In addition a single dose of NNC0114-0000-0005 administered s.c. (under the skin) in healthy subjects.
16223943|NCT01208506|Drug|NNC0114-0000-0005|A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects. In addition a single dose of NNC0114-0000-0005 may be administered s.c. (under the skin) in healthy subjects based on safety data.
16223944|NCT01208506|Drug|NNC0114-0000-0005|A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects. Based on safety data, a single dose of NNC0114-0000-0005 may be administered i.v. (into the vein) in subjects with RA. In addition a single dose of NNC0114-0000-0005 may be administered s.c. (under the skin) in healthy subjects based on safety data.
16223945|NCT01208506|Drug|NNC0114-0000-0005|A single dose of NNC0114-0000-0005 administered i.v. (into the vein) in healthy subjects. Based on safety data, a single dose of NNC0114-0000-0005 may be administered i.v. (into the vein) in subjects with RA.
16223946|NCT01208506|Drug|placebo|A single dose of NNC0114-0000-0005 placebo.
16223947|NCT01208493|Other|preterm infant formula with high protein levels|minimum 3 weeks feeding until hospital discharge
16223948|NCT01208493|Other|preterm standard infant formula|minimum 3 weeks feeding until hospital discharge
16223949|NCT01208480|Drug|Avastin, docetaxel, carboplatin|Avastin, docetaxel, carboplatin
16223950|NCT01208467|Other|Laboratory Biomarker Analysis|Correlative studies
16223951|NCT01208454|Drug|Isotretinoin|Given PO
16223952|NCT01208454|Other|Laboratory Biomarker Analysis|Correlative studies
16223953|NCT01208454|Other|Pharmacological Study|Correlative studies
16223954|NCT01208454|Drug|Vorinostat|Given PO
16223955|NCT01208441|Drug|letrozole|
16223956|NCT01208441|Drug|gamma-secretase/Notch signalling pathway inhibitor RO4929097|
16223957|NCT01208441|Procedure|therapeutic conventional surgery|
16223958|NCT01208441|Procedure|breast biopsy|
16223959|NCT01208441|Other|diagnostic laboratory biomarker analysis|
16223960|NCT01208441|Other|pharmacological study|
16223961|NCT01208428|Behavioral|Conventional cognitive behavioral therapy|Conventional cognitive behavioral therapy is a standard treatment for depression. There will be ten 50-minute sessions delivered.
16224007|NCT01208168|Drug|Vehicle alone|nail lacquer, once daily, 52 weeks
16224008|NCT01208155|Drug|Fostamatinib|Oral tablets, 50 mg x 2, single dose
16223963|NCT01208415|Device|Endovascular repair for aortoiliac or iliac aneurysms.|Implantation of the Zenith® Branch Endovascular Graft-Iliac Bifurcation, the Zenith® Connection Endovascular Covered Stent/ConnectSX™ and the Zenith® Flex AAA Endovascular Graft.
16223964|NCT01208402|Drug|Esmolol|Infusion will be started at 50 mcg/kg/min for 4 minutes and titrated in increments of 50 mcg/kg/min up to a maximum of 300mcg/kg/min (maintenance dose) to maintain a heart rate between 60 and 80 beats per minute (bpm) while maintaining a minimum systolic blood pressure (SBP) of 95 mmHg during the length of surgery and up to 12 hours post-operatively.
16223965|NCT01208389|Biological|voretigene neparvovec-rzyl|One time, subretinal administration of 1.5E11 vg AAV2-hRPE65v2 vector in 300 microliters to the contralateral, previously uninjected eye.
16223966|NCT01208376|Other|Fibroscan|Fibroscan and Serum Fibrose-marker
16223967|NCT01208363|Dietary Supplement|Cowpea fortified with NaFeEDTA, in form of Toubani.|66g raw Cowpea fortified with 10 mg Fe as NaFeEDTA, in form of Toubani, a cowpea snack. Ther snack will be given to the participants 3 times per week, for six month integrated in the school feeding trial.
16223968|NCT01208350|Behavioral|No intervention|Monthly weigh-ins for 6 months without financial incentives associated with weight loss, and follow-up weigh-in at 9 months
16223969|NCT01208350|Behavioral|Group-based payout|Monthly weigh-ins for 6 months where five sequential participants, randomized to this condition, will be joined into virtual groups where individual rewards for weight loss are dependent on the weight loss of others in the group, with follow-up weigh in at 9 months
16223970|NCT01208350|Behavioral|Individual payout|Monthly weigh-ins for 6 months and if monthly goals are met, participants receive payout at the end of the month, with follow-up weigh-in at 9 months
16223971|NCT01208337|Drug|Alemtuzumab|Alemtuzumab is a monoclonal antibody directed against the CD52 antigen. A single dose of 0.3-0.4 mg/kg is given to enrolled subjects at the time of intestine transplantation, 30 minutes after premedication with acetaminophen, diphenhydramine and methylprednisolone
16223972|NCT01208324|Drug|estrogen patch|150 subjects will be enrolled in a double blind placebo controlled study where they will be randomized to receive either treatment with 17β-estradiol (Vivelle Dot® 0.10 - 0.15 mg/day) or a look-alike placebo patch for a total of approximately 8 weeks. There will be four fMRI test sequences: two test sequences one week apart prior to estrogen treatment (ET) or placebo treatment (PT), and two sequences one week apart following approximately 6-weeks of double-blind ET or PT. During each test day, all subjects will have their blood drawn at specific time intervals and undergo a battery of cognitive testing.While on the ET or PT treatment, all subjects will be instructed to change the patch every 3.5 days.
16223973|NCT01208324|Drug|Amino acids|31.5 mg of amino acids or 31.5 mg of lactose will be administered to subjects on each of their 4 test days. On 2 of the test days subjects will receive the active pills (amino acids) and on the other 2 test days subjects will receive the placebo pills (lactose).
16223974|NCT01208324|Drug|Placebo Patch|placebo
16223975|NCT01208324|Drug|Placebo pills|There are 4 test days in this study. Each test day will involve the ingestion of 70 capsules. During one of each pair of tests, the 70 capsules will contain 31.5 g of lactose (sham depletion), while during the other test they will contain a total of 31.5 g of amino acids.
16223976|NCT01208298|Device|Cold Sore Patch|All eligible subjects received CSP-Night at Screening Visit 1. Subjects were instructed to initiate therapy within approximately 1 hour of onset of their first sign or symptom. Treatment was continued until the lesion healed, or for a maximum of 10 days. All subjects were expected to return to the study center for clinical assessments within 24 hours and 48 hours after initiating treatment, and every other day thereafter, with a final visit at Day 10 or at the time of completion/ discontinuation if before Day 10.
16223977|NCT01208285|Drug|VX-770|150 mg oral tablet
16223978|NCT01208272|Behavioral|Cognitive Behavioral Therapy (CBT)|
16223979|NCT01208272|Behavioral|Interpersonal Therapy (IPT)|
16223980|NCT01208259|Behavioral|Cognitive Behavioral Therapy (CBT)|
16223981|NCT01208259|Behavioral|Interpersonal Therapy (IPT)|
16223982|NCT01208233|Drug|PF-03049423|1 mg of PF-03049423 daily for 90 days
16223983|NCT01208233|Drug|PF-03049423|3 mg of PF-03049423 daily for 90 days
16223984|NCT01208233|Drug|PF-03049423|6 mg of PF-03049423 daily for 90 days
16223985|NCT01208233|Other|Placebo|Placebo of PF-03049423 daily for 90 days
16223986|NCT01208220|Device|Negative Pressure Wound Therapy|NPWT changed 3 times weekly
16223987|NCT01208220|Biological|Collagenase Ointment|Apply TIW
16223988|NCT01208207|Drug|Part I - etoricoxib 60 mg|etoricoxib 60 mg oral tablet once daily for 6 weeks
16223989|NCT01208207|Drug|Part I - etoricoxib 90 mg|etoricoxib 90 mg oral tablet once daily for 6 weeks
16223990|NCT01208207|Drug|Part I- naproxen 1000 mg|naproxen 500 mg oral tablet twice daily for 6 weeks
16223991|NCT01208207|Drug|Part I - Placebo to naproxen 500 mg|Placebo to naproxen 500 mg oral tablet twice daily for 6 weeks
16223992|NCT01208207|Drug|Part II- etoricoxib 60 mg|etoricoxib 60 mg oral tablet once daily for 20 weeks
16223993|NCT01208207|Drug|Part II- etoricoxib 90 mg|etoricoxib 90 mg oral tablet once daily for 20 weeks
16223994|NCT01208207|Drug|Part II- naproxen 1000 mg|naproxen 500 mg oral tablet twice daily for 20 weeks
16223995|NCT01208207|Drug|Part I - Placebo to etoricoxib 60 mg|Placebo to etoricoxib 60 mg oral tablet once daily for 6 weeks.
16223996|NCT01208207|Drug|Part I - Placebo to etoricoxib 90 mg|Placebo to etoricoxib 90 mg oral tablet once daily for 6 weeks.
16223997|NCT01208207|Drug|Part II- Placebo to etoricoxib 60 mg|Placebo to etoricoxib 60 mg oral tablet once daily for 20 weeks.
16223998|NCT01208207|Drug|Part II - Placebo to etoricoxib 90 mg|Placebo to etoricoxib 90 mg oral tablet once daily for 20 weeks.
16223999|NCT01208207|Drug|Part II- Placebo to naproxen 500 mg|Placebo to naproxen 500 mg orally twice daily for 20 weeks.
16224000|NCT01208194|Drug|MGN1703|solution, 60 mg, twice a week, until progression
16224001|NCT01208194|Drug|Placebo|solution, 60 mg, twice a week, until progression
16224002|NCT01208181|Drug|Etoricoxib 60 mg|One tablet orally once daily for 6 weeks.
16224003|NCT01208181|Drug|Etoricoxib 90 mg|One tablet orally once daily for 6 weeks.
16224004|NCT01208181|Drug|Placebo to Etoricoxib 60 mg|One tablet orally once daily for 6 weeks.
16224005|NCT01208181|Drug|Placebo to Etoricoxib 90 mg|One tablet orally once daily for 6 weeks
16224006|NCT01208168|Drug|NAB001|nail lacquer, once daily, 52 weeks
16224010|NCT01208155|Drug|Fostamatinib|Oral tablets, 100 mg Batch 2, single dose
16224011|NCT01208155|Drug|Fostamatinib|Oral tablets, 100 mg Batch 3, single dose
16224012|NCT01208142|Other|standard of care treatment|weekly standardized physical therapy and daily wear of an AFO
16224013|NCT01208142|Device|Ankle Flexion Dynasplint|Weekly standardized physical therapy, daily wear of an AFO and nightly wear of the ankle flexion Dynasplint
16224014|NCT01208129|Drug|NAB001|nail lacquer, once daily, 52 weeks
16224015|NCT01208129|Drug|Placebo control|nail lacquer, once daily, 52 weeks
16224016|NCT01208116|Other|Cardiovascular events|"Coronary intervention
~Infarction
~Congestive heart failure
~Stroke
~Cardiac death"
16224017|NCT01208103|Biological|Bevacizumab|Given IV
16224018|NCT01208103|Drug|Capecitabine|Given PO
16224019|NCT01208103|Drug|Oxaliplatin|Given CVC
16224020|NCT01208090|Drug|ACT-128800|ACT-128800 (Dose 1 or Dose 2) or matching placebo administered orally once daily
16224021|NCT01208090|Drug|Placebo|ACT-128800 (Dose 1 or Dose 2) or matching placebo administered orally once daily
16224022|NCT01208064|Drug|pazopanib hydrochloride|
16224023|NCT01208064|Other|laboratory biomarker analysis|
16224024|NCT01208064|Other|pharmacogenomic studies|
16224025|NCT01208064|Other|pharmacological study|
16224026|NCT01208064|Procedure|quality-of-life assessment|
16224027|NCT01208051|Drug|Cediranib|Given PO
16224028|NCT01208051|Drug|Cediranib Maleate|Given PO
16224029|NCT01208051|Other|Laboratory Biomarker Analysis|Correlative studies
16224030|NCT01208051|Drug|Lenalidomide|Given PO
16224031|NCT01208038|Drug|Intrinsa Transdermal testosterone patch|300 microgram transdermal testosterone patch, applied twice weekly for 12 weeks
16224032|NCT01208025|Other|Magnetic Resonance Imaging (MRI), Multidetector Computed Tomography (MDCT), Ultrasonography (US), Transcranial Doppler (TCD)|3 Tesla Magnetic Resonance Imaging (MRI), Multidetector Computed Tomography (MDCT), Ultrasonography (US), Transcranial Doppler (TCD)
16224033|NCT01208012|Drug|Victoza®|Patients taking Metformin at individual dose and Liraglutide 0.6 mg once daily for the 1st week, 1.2 mg daily for another 5 weeks, 1.8 mg daily for another 6 weeks. When arrived at the dosage of 1.8 mg daily and the dose is not tolerated by the patient, the dose of Liraglutide can be decreased.Liraglutide is injected in the subcutaneous tissue once daily
16224034|NCT01207999|Procedure|Collection of cervical cancer tissue samples|Cervical samples will be tested for histopathology diagnosis and human papillomavirus DNA testing.
16224035|NCT01207999|Other|Data collection|Questionnaire completion
16224036|NCT01207986|Radiation|Low dose computed tomography (CT)|
16224037|NCT01207973|Drug|BI 113823|5 dose-groups of multiple oral doses of BI 113823
16224038|NCT01207960|Behavioral|Eye Movement Desensitization and Reprocessing (EMDR)|The intervention consists of three 90-minute sessions of individual psychotherapy. Sessions take place weekly according to a treatment manual.
16224039|NCT01207947|Drug|Vardenafil (Levitra, BAY38-9456)|Patients under daily life treatment receiving Levitra according to local drug information.
16224040|NCT01207934|Dietary Supplement|placebo|saline placebo
16224041|NCT01207934|Drug|low-dose leptin|30mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
16224042|NCT01207934|Drug|high-dose leptin|80mg per day of recombinant methionyl human (r-met hu) leptin for fourteen days
16224043|NCT01207921|Drug|Lenalidomide|
16224044|NCT01207908|Drug|IGF-1|IGF-1 will be administered once daily by subcutaneous injection every morning with breakfast. Duration 6 months.
16224045|NCT01207895|Device|PET imaging with [18F]-FLT|Up to three [18F]-FLT PET scans; one before beginning treatment, one at week three of treatment, and one at week 11, after completion of treatment but prior to surgery.
16224046|NCT01207895|Drug|[18F]-fluorodeoxythymidine|[18F]-fluorodeoxythymidine is administered intravenously approximately 60 minutes prior to the start of PET image acquisition.
16224047|NCT01207869|Biological|ucMSCs|the ucMSCs suspension(3× 106 cells per kg of the patient's weight) will be instilled through a 6 French end-hole catheter inserted into the infant's endotracheal tube
16224048|NCT01207869|Other|Normal saline|the same amount of ucMSCs suspension will be instilled through a 6 French end-hole catheter inserted into the infant's endotracheal tube
16224049|NCT01207856|Behavioral|specific cognitive rehabilitation|"Individual rehabilitation procedures will be focused on attention, executive functions, IPS and working memory. The program will be tailored to each patient cognitive status depending on the impairments identified during the initial assessment while maintaining a systematic work on attention and executive functions. A total of 50 sessions lasting one hour at a rate of 3 sessions per week for a total period of 4 months will be proposed. Sessions will include varied exercises according to complexity and presentation modality, using computerized and paper-and-pencil tasks and metacognitive training. Work will be progressive, depending on the progresses achieved (increase complexity and intensity of the exercises according to success at the previous level of exercises)."
16224050|NCT01207856|Behavioral|non specific cognitive rehabilitation|A total of 50 sessions lasting one hour at a rate of 3 sessions per week for a total period of 4 months will be proposed by group composed to 5 patients
16224051|NCT01207856|Other|no intervention|no intervention
16224052|NCT01207843|Behavioral|Imaging|CT image validation and lesion measurement, as well as comparison of different CT phases
16224053|NCT01207830|Device|Endo Bypass System|Subject is implanted with the device for up to 3 years.
16224054|NCT01207817|Other|Pupillometry|Pupillometry readings will be taken at low, intermediate and high ambient light
16224055|NCT01207804|Device|ValenTx Endo Bypass System|Patient is implanted with device and followed for 12 weeks
16224056|NCT01207791|Behavioral|screening|Brief screening to assess eligibility and collect minimal baseline data
16224057|NCT01207791|Behavioral|assessment|comprehensive substance use assessment
16224058|NCT01207791|Behavioral|referral|referral to treatment if indicated or requested
16224059|NCT01207791|Behavioral|Brief intervention|30-minute brief intervention session in ED
16224060|NCT01207791|Behavioral|booster sessions|two 15-minute booster counseling sessions conducted by telephone
16224095|NCT01207466|Device|Nelfilcon A investigational contact lens|Investigational, soft contact lens for astigmatism worn on a daily disposable basis.
16224061|NCT01207765|Drug|indium-111-ibritumomab tiuxetan|1.5mg of 111In Zevalin (containing 5 mCi of 111In) will be used for radioimaging. 111In Zevalin will be administered by a 10 minute slow IV push injection immediately following completion of the rituximab infusion. 111In Zevalin may be injected by stopping the flow from the IV bag and injecting the radiolabeled antibody directly into the IV line. A 0.22 micron filter must be on line between the drug infusion port and the patient. The line must be flushed with at least 10cc of normal saline after 111In Zevalin has been injected.
16224062|NCT01207765|Drug|90Y Zevalin|Each patient will receive a single therapeutic dose of 90Y Zevalin at a dose of 0.4 mCi/kg, capped at a maximum dose of 32 mCi. 90Y Zevalin will be administered intravenously as a slow IV push over 10 minutes. 90Y Zevalin may be directly infused by stopping the flow from the IV bag and injecting the radiolabeled antibody directly into the IV line. A 0.22 micron filter must be on line between the syringe and the infusion port. The line must be flushed with at least 10cc normal saline after 90Y Zevalin has been infused.
16224063|NCT01207752|Drug|Systane Balance|Artificial tear emulsion drop
16224064|NCT01207752|Drug|Optive Lubricant Eye Drops|Artificial tear eye drop
16224065|NCT01207739|Drug|Doxycycline|After open-label i.v. ceftriaxone 2000 mg qd via a peripheral i.v. catheter: oral Doxycycline 100 mg combined with a placebo b.i.d. for 12 weeks
16224066|NCT01207739|Drug|Clarithromycin and hydroxychloroquine|After open-label i.v. ceftriaxone 2000 mg qd via a peripheral i.v. catheter: clarithromycin 500 mg combined with hydroxychloroquine 200 mg b.i.d. for 12 weeks
16224067|NCT01207739|Drug|Placebo|After open-label i.v. ceftriaxone 2000 mg qd via a peripheral i.v. catheter: 12 weeks' course of double placebo b.i.d.
16224068|NCT01207726|Drug|Azacitidine|Given SC
16224069|NCT01207726|Drug|Entinostat|Given PO
16224070|NCT01207726|Other|Laboratory Biomarker Analysis|Correlative studies
16224071|NCT01207700|Behavioral|CHW based intervention post ACS|CHW is trained and supervised to provide interventions that could improved adherence to post ACS care
16224072|NCT01207687|Biological|bevacizumab|Given IV
16224073|NCT01207687|Other|laboratory biomarker analysis|Correlative studies
16224074|NCT01207687|Procedure|quality-of-life assessment|Ancillary studies
16224075|NCT01207674|Other|Summons of patients and filling questionnaire|The study is conducted at the same time by 7 French specialised centres. The recruitment period is comprised between April 2009 and September 2011.For the first stage of the study, an initial evaluation will be performed at the time of recruitment. It consists in an individual face-to-face interview based on standardized and semi-structured questionnaires, during approximately one and half hour, and focused mainly on gambling trajectory and severity, and on psychiatric and addictive comorbidities. The evaluation is completed by a set of self-administered questionnaires focused on cognitive distortions, temperament and character, ADHD, etc.For the second stage of the study, the cohort will be re-evaluated each year, based on the same questionnaires that for initial evaluation. Each participant will be followed-up during 5 years. The study will thus end up in September 2016.
16224076|NCT01207661|Biological|Mesenchymal Injection|Intra Articular Injection of Mesenchymal cells to the knee joint
16224077|NCT01207648|Drug|Rebif®|This is an retrospective cohort study in Pediatric participants including both children (aged less than 12 years) and adolescents (aged 12 to less than 18 years) who were exposed to Rebif® for treatment of demyelinating events (Dose regimen as per investigator's decision)
16224078|NCT01207635|Procedure|Ductal Lavage Fluid Collection|Procedure of inserting a small catheter into the ductal openings in the nipple and washing out cells from inside the duct.
16224079|NCT01207622|Drug|Atomoxetine|
16224080|NCT01207622|Drug|Placebo|
16224081|NCT01207609|Procedure|Laparoscopic Gastric Plication|The procedure is performed laparoscopic. The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3-5 cm from the pylorus and ending at the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected. At least two rows stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. A calibration tube or endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure.
16224082|NCT01207596|Drug|Hydromorphone|Oral hydromorphone extended release, once daily
16224083|NCT01207583|Other|Non-interventional observational study|Non-interventional observational study
16224084|NCT01207570|Procedure|Endermotherapy|The subjects will receive a single session of endermotherapy applied to the gastrocnemius/soleus muscle on the more affected side for 5 minutes. The treatment will be conducted by a qualified physiotherapist.
16224085|NCT01207570|Procedure|Passive manual stretching|The subjects will receive a single session of passive manual stretching of the gastrocnemius/soleus muscle on the more affected side. The treatment will be given by a qualified physiotherapist.
16224086|NCT01207557|Behavioral|Standard Education Only|50% of non-immunized personnel 4 weeks following start of campaign will be given standard education materials and tested on their confidence with their immunization decision
16224087|NCT01207557|Behavioral|Standard Education Plus OIDA|50% of non-immunized personnel 4 weeks following start of campaign will be given standard education materials and tested on their confidence with their immunization decision
16224088|NCT01207544|Behavioral|Fitball exercise|Supervised fitball exercise program session (1 hour per session, 1 session per week, for 8 consecutive weeks), supplemented by daily home exercise program.
16224089|NCT01207544|Behavioral|task-oriented motor training program|Task-oriented motor exercise program session (1 hour per session, 1 session per week, for 8 consecutive weeks), supplemented by daily home exercise program.
16224090|NCT01207518|Behavioral|Intervention Group|This group of healthcare organizations will be given the Guide, web-based tools and access to a Guide facilitator throughout the study.
16224091|NCT01207518|Behavioral|Control Group|This group will provide their immunization rates for the base and study years and will provide information on their campaign activities. No other intervention will be provided.
16224092|NCT01207505|Behavioral|Enhancing Emotion Regulation|12 week of group therapy 3 modules: 1) mindfulness, 2) emotion regulation, 3)distress tolerance
16224093|NCT01207492|Drug|nilotinib|Taken orally twice daily
16224094|NCT01207479|Device|VitalaTM|A 43 day study design has been selected in order to capture meaningful safety and performance data of the Vitala™ device when used with these moldable products.
16224096|NCT01207466|Device|Nelfilcon A commercial contact lens|Commercially marketed, soft contact lens for astigmatism worn on a daily disposable basis.
16224097|NCT01207453|Drug|Milnacipran|Milnacipran comes in 50 mg tablets and is taken orally. Participants will gradually be increased to a target dose of 50 mg twice daily.
16224098|NCT01207453|Drug|Placebo|
16224099|NCT01207440|Drug|Ponatinib|Ponatinib tablets.
16224100|NCT01207427|Drug|Placebo|
16224101|NCT01207427|Drug|ADL5945 0.1 mg|
16224102|NCT01207427|Drug|ADL5945 0.25 mg|
16224103|NCT01207414|Drug|iloperidone|Iloperidone tablets supplied at doses of 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg and 12 mg to achieve a target dose of 12-24 mg/day for 12 weeks.
16224104|NCT01207401|Drug|Lidocaine|1% Lidocaine
16224105|NCT01207388|Drug|Blinatumomab|Continuous intravenous infusion
16224106|NCT01207375|Behavioral|memory retraining exercises|Memory retraining exercises will be administered on a laptop computer twice a week for 5 weeks (10 training sessions).
16224107|NCT01207375|Behavioral|placebo control memory exercises|Placebo control memory exercises will be administered on a laptop computer twice a week for five weeks (10 placebo control sessions.
16224108|NCT01207349|Behavioral|Secondary prevention intervention trial|Close follow-up by nurses, exercise physiologist and dieteticians
16224109|NCT01207349|Behavioral|standard follow up|
16224110|NCT01207336|Device|combined transcranial direct current stimulation and electrical peripheral nerve stimulation|tDCS: 1,2 mA 13 minutes rEPNS (radial nerve): 5 Hz, 0,7 x MT
16224111|NCT01207323|Drug|MEHD7945A|MEHD7945A will be administered as specified in the individual arms.
16224112|NCT01207310|Behavioral|smoking cessation counseling|two 60-minute face-to-face treatment sessions and three 20-minute follow-up contacts at weeks 2, 3, and 9
16224113|NCT01207310|Drug|Nicotine patch|8 weeks' worth of nicotine patches
16224114|NCT01207310|Device|alphanumeric pager|therapeutic messages to be delivered for three months
16224115|NCT01207297|Drug|Tacrolimus|"The calcineurin inhibitor is widely administered for organ transplantation，which establish the current method for lupus nephritis (LN).
~20 patients with LN were self-assigned the therapy of TAC and prednisone for 12 months. The dosage was adjusted to achieve a whole blood TAC 12 h trough concentration."
16224116|NCT01207297|Drug|cyclophosphamide|20 patients with LN were self-assigned the protolcol of intravenous cyclophosphamide (750mg/m2 per month)/prednisone for six months followed by azathioprine(100mg/day)/prednisone for six months.
16224117|NCT01207284|Other|Physical Therapy|strengthening passive and active stretching balance training gait training
16224118|NCT01207271|Behavioral|Cognitive Therapy|16 sessions of cognitive therapy administered weekly by a community mental health therapist
16224119|NCT01207271|Behavioral|Supportive-Expressive Psychodynamic Therapy|16 sessions of supportive-expressive psychodynamic therapy administered weekly by a community mental health therapist
16224120|NCT01207258|Behavioral|Motivational Enhancement Therapy|20 minute manual-driven, optionally audio-recorded Motivational Enhancement Training intervention by a MI-trained therapist during their ED visit and a 10-15 minute phone booster at 7 to 10 days.
16224121|NCT01207245|Other|Tobramycin time of administration|Random allocation to time of day of administration of tobramycin
16224122|NCT01207232|Behavioral|Planning Prompt|A prompt to write down a planned date (or date and time) for getting a flu shot
16224123|NCT01207232|Behavioral|Control Condition|A basic reminder mailing prompted each subject to get their flu shot.
16224124|NCT01207219|Behavioral|Yoga therapy|3 sessions per week for 12 weeks, total 36 sessions. Each session lasts around one hour.
16224125|NCT01207219|Behavioral|Aerobic exercise|3 session per week for 12 weeks, total 36 sessions. Each session lasts around one hour.
16224126|NCT01207206|Drug|oral ketamine|"The group will be divided into two pain matched groups of 25 each. One group will receive Ketamine (K group) and the other placebo (P). Both the researchers and the patients will not know to which group they belong. Four days prior to the beginning of the research the patients will document, using an ad-hoc diary, in predetermined hours, four times a day the level (VAS) of pain, sedation and vomiting scores, and other side effects. Pain will be assessed using a Visual Analog Scale (VAS) (0-10).
~The documentation will continue throughout the research period. The Ketamine or plaecebo will also be taken in a predetermined hours to avoid an effect of diurnal disruption on pain perception"
16224127|NCT01207193|Biological|cell injection|injection of mesenchymal cells to bone cyst defect
16224128|NCT01207180|Other|Phone call follow-up|A nurse will call the patient to counsel patients on their medications and following up with their primary care provider.
16224129|NCT01207180|Other|Satisfaction survey|Patients will be given a satisfaction survey.
16224130|NCT01207180|Other|Control group --- no intervention|Control group
16224131|NCT01207128|Drug|Voriconazole, micafungin|Patients will receive either IV micafungin 100 mg or placebo equivalent daily. Intravenous (IV)Voriconazole will be administered at a loading dose of 6 mg/kg every 12 hours for the first 24 hours followed by a maintenance dose of 4 mg/kg every 12 hours. Patients may be switched to oral voriconazole 200 mg BID provided aspergillosis response is achieved and gastrointestinal functions are intact.
16224132|NCT01207115|Drug|ABT-652|ABT-652 capsules - twice daily for 8 weeks. The dose of ABT-652 will depend on the Arm
16224133|NCT01207115|Drug|Placebo|Placebo capsules - twice daily for 8 weeks
16224134|NCT01207115|Drug|Naproxen|Naproxen capsules - twice daily for 8 weeks
16224135|NCT01207102|Drug|Abraxane|Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days
16224136|NCT01207102|Drug|Carboplatin|area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days
16224137|NCT01207089|Drug|AZD8329|AZD8329 Oral Solution 20mg/ml
16224138|NCT01207089|Drug|Placebo|Placebo AZD8329 Oral Solution
16224139|NCT01207076|Biological|90Y-AHN-12|"The intervention consists of two parts.
~The dose of cold AHN-12 to achieve favorable biodistribution through imaging using 111In-AHN-12.
~Dose escalation of nonradiolabeled AHN-12:
~Dose level= -1 0.20 mg/kg, Dose level=1 0.40 mg/kg, Dose level=2 0.80 mg/kg, Dose level=3 1.20 mg/kg, Dose level=4 1.60 mg/kg, Dose level=5 2.00 mg/kg
~Phase I therapeutic dosing of cold AHN-12 at dose established plus 90Y-AHN-12.
~the starting 90Y-AHN-12 dose level will be 4 Gy with the dose escalated in increments of 4 Gy to a maximum of 20 Gy."
16224140|NCT01207063|Other|Radiotherapy and concurrent chemo-therapy|Radiotherapy and concurrent chemo-therapy
16224141|NCT01207050|Drug|Ramelteon|8mg capsule taken within one half hour of bedtime each night over the three night study period.
16224142|NCT01207050|Dietary Supplement|Placebo|Control treatment
16224143|NCT01207037|Procedure|blood samples and scintigraphy|at 3 months, 6 months, 12 months, 18 months and 24 months will allow a clinical evaluation and an additional sampling of blood of 5 mL at each visit Scintigraphy at 6 months and 18 months
16224144|NCT01207024|Other|knee MRI|knee MRI before surgery (inclusion) and one year after
16224145|NCT01207011|Drug|Amrubicin hydrocloride|AMR was administered i.v. by 35mg/m2 at day 1, 2 and 3 followed by 3 week rest as 1 course.
16224146|NCT01207011|Drug|Docetaxel|DOC was administered i.v. by 60mg/m2 at day 1 followed by 3 week rest as 1 course.
16224147|NCT01206998|Drug|Vaginal progesterone gel|Subjects will receive daily vaginal progesterone gel provided by Columbia laboratories (1.125g progesterone gel containing 90mg (8%) progesterone)
16224148|NCT01206998|Drug|Placebo vaginal gel|Subjects will receive daily placebo vaginal gel, made of an identical bioadhesive delivery system as the active drug
16224149|NCT01206985|Other|Von Frey electronic|Change in pain threshold testing mechanical stimulation (von Frey electronic)
16224150|NCT01206972|Drug|Rivaroxaban (BAY59-7939)|daily dose: 5mg/day (5mg, once daily) for 11 to 12 days (±2 days)
16224151|NCT01206972|Drug|Rivaroxaban (BAY59-7939)|daily dose: 7.5mg/day (7.5mg, once daily) for 11 to 12 days (±2 days)
16224152|NCT01206972|Drug|Rivaroxaban (BAY59-7939)|daily dose: 10mg/day (10mg, once daily) for 11 to 12 days (±2 days)
16224153|NCT01206972|Drug|Enoxaparin|daily dose: 40mg/day (20mg, twice daily) for 10 to 11 days (±2 days)
16224154|NCT01206946|Drug|Betamethasone|A single course of betamethasone (two doses of 12 mg/dose given at 24 hourly intervals)
16224155|NCT01206946|Other|Normal Saline|Two doses of 2ml of normal saline given at 24 hourly intervals
16224156|NCT01206907|Drug|oxymorphone IR|oxymorphone IR liquid
16224157|NCT01206894|Procedure|Transthoracic Ultrasound|1 transthoracic ultrasound will be performed the evening before the thoracic surgery
16224158|NCT01206881|Drug|pegylated liposomal doxorubicin|35 mg/m2, IV, day 1 every 21 days, 4 cycles
16224159|NCT01206868|Procedure|Fenestration|Fenestration of the peritoneum according to the length of the transplanted kidney
16224160|NCT01206868|Procedure|Control|Standard kidney transplantation
16224161|NCT01206855|Device|MIST Therapy|Low-frequency, non-contact ultrasound system delivering therapeutic ultrasound via a fine saline mist to the wound bed without direct contact of the device with the body.
16224162|NCT01206855|Other|Standard Postoperative Incision Care|Incision cleansing, topical creams, and dressing as needed
16224163|NCT01206842|Other|Training in Affect Recognition|A 12-session social cognitive training programming covering emotion perception and social perception administered in a group setting to up to four participants with schizophrenia at the time
16224164|NCT01206829|Behavioral|8-session CBTcourse|Hearing impaired workers voluntarily sign up for an 8 session cognitive therapy course. The study has a waiting list control group design. Participants will be randomized assigned to either an experiment group that will be offered to start on an immediate course, or a control group that will be offered the same course 12 months later.
16224165|NCT01206829|Behavioral|8 session cognitive behavioral therapy|8 sessions cognitive behavioral therapy in group
16224166|NCT01206816|Drug|BI 6727 + BIBW 2992|BI 6727 administered i.v. every 21 days + BIBW 2992 given orally once a day
16224167|NCT01206803|Drug|Ovarian stimulation in a GnRH-antagonist protocol|Long-acting FSH 150µg & daily recombinant FSH 200 IU, GnRH-antagonist 0.25mg, 5,000-10,000 IU urinary hCG, triptorelin 0.2mg, vaginal progesterone
16224168|NCT01206790|Behavioral|NET|Narrative Exposure Therapy for traumatized survivors of organized violence
16224169|NCT01206777|Drug|Rituximab|Dose 2 of Rituximab IVPB will be started at a rate of 100 mg/hr for the first 15 minutes. If tolerated, the remainder of the bag will be infused over 45 minutes.
16224170|NCT01206764|Drug|RAD001|
16224171|NCT01206751|Other|Chest imaging technique and case presentation|
16224172|NCT01206738|Behavioral|Persuasive communication|The persuasive intervention aimed to reinforce the GP's beliefs about the positive consequences of managing sore throat without prescribing antibiotics.
16224173|NCT01206738|Behavioral|Action plan|This intervention was an action plan, supporting the GP to deal with two difficult prescribing situations: 1) a distressed patient (or often distressed parent of a child patient) 2) a patient demanding an antibiotic
16224174|NCT01206738|Behavioral|General intervention|No additional information was provided; the general information was the information already available to GPs about antibiotic prescribing.
16224175|NCT01206725|Other|Exercise|"Moderate Intensity Exercise Group (ME). Exercise equivalent to the current exercise guidelines. In total 210 minutes per week of continuous moderate intensity (70% HRmax) exercise. Home based training.
~Aerobic interval training (AIT). Exercise equivalent to the current guidelines achieved through high-intensity interval training.The exercise starts with warming-up for 10-min at 70% of HRmax before performing 4x4min intervals at 90-95% of HRmax, with 3-min active recovery at 70% of HRmax between each interval, and a 5-min cool-down period, giving a total of 40-min."
16224176|NCT01206699|Drug|corticoid (altim® 1.5 ml)|Active arm : anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with corticoid (altim® 1.5 ml)
16224177|NCT01206699|Drug|physiological solution (1.5 ml)|Control arm: anesthetic bloc (1 ml of lidocaïne 1%) immediately followed with physiological solution (1.5 ml)
16224178|NCT01206686|Behavioral|Planning Prompt|Patients were prompted to write down a planned date (and in some cases time) for receiving a flu shot.
16224179|NCT01206686|Behavioral|Default Appointment|Patients were given a suggested date and time for receiving a flu shot.
16224180|NCT01206686|Behavioral|Control|Patients were provided with basic information (present in all conditions) about when and where they could receive a flu shot, but they were given no further treatment.
16224181|NCT01206673|Other|Blood sampling|One blood sampling is required for the research
16224182|NCT01206660|Drug|Desoximetasone Spray 0.25%|Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
16224183|NCT01206660|Drug|placebo|Placebo administered to affected area twice a day for 28 days
16224184|NCT01206647|Drug|Metformin and Saxagliptin|Metformin 500mg/daily titrated to 2000mg/d in 4 Weeks (continued for 20 weeks) Saxagliptin 5 mg daily over complete trial
16224185|NCT01206634|Procedure|Regenerative injection therapy|Injections of 1cc of a 15% dextrose and 0.6% lidocaine solution free of adrenaline in each of eight administration sites in the collateral ligaments and a 5 cc injection of a 20% dextrose and 0.5% lidocaine without adrenaline solution inside the knee joint.
16224186|NCT01206634|Behavioral|Exercise|the exercise program consists of 4 strengthening exercises for which participants are asked to perform 3 sets of 10 repetitions daily
16224187|NCT01206608|Drug|SKY0402 + bupivacaine HCl|Low-dose SKY0402 administered locally into one breast pocket and 75 mg bupivacaine HCl administered locally into the other breast pocket
16224188|NCT01206608|Drug|Mid-dose SKY0402 + bupivacaine HCl|Mid-dose SKY0402 administered locally into one breast pocket and 75 mg bupivacaine HCl administered locally into the other breast pocket
16224189|NCT01206595|Drug|SKY0402|Single dose of SKY0402 administered as a nerve block
16224190|NCT01206595|Drug|Bupivacaine HCl|Single dose of 125 mg administered as a nerve block
16224191|NCT01206582|Biological|Hemin|10 iv infusions for 8 weeks
16224192|NCT01206582|Biological|Albumin|10 iv infusions for 8 weeks
16224193|NCT01206569|Drug|Long-acting tacrolimus (Advagraf, Astellas Pharma)|Long-acting tacrolimus (Advagraf, Astellas Pharma) will be started at single daily dose of 0.15-0.2 mg/kg/day for 6 months.
16224194|NCT01206543|Other|Intraoperative imaging using 1.5T MRI|Intraoperative imaging and determination of degree of resection / complete tumor removal
16224195|NCT01206530|Drug|Hydroxychloroquine|Dose:600 or 800 mg Route:PO daily Treatment Administration: Daily
16224196|NCT01206530|Drug|Oxaliplatin|Dose: 85mg/m2 Route: IV infusion over 2 hours Treatment Administration: Day 1
16224197|NCT01206530|Drug|Leucovorin|Dose: 400mg/m2 Route IV infusion over 2 hours Treatment Administration: Day 1
16224198|NCT01206530|Drug|5-fluorouracil|Dose: 400mg/m2 Route: IV bolus immediately following leucovorin Treatment Administration Day 1
16224199|NCT01206530|Drug|5-fluorouracil|"Dose: 2,400mg/m2 Route: IV continuous infusion over 46 hours immediately following bolus injection.
~Treatment Administration: Days 1-2"
16224200|NCT01206530|Drug|Bevacizumab|
16224201|NCT01206517|Drug|Asenapine 2.5 mg|Asenapine tablet, sublingually (SL), 2.5 mg b.i.d. on Days 1-6 and one 2.5 mg tablet, SL, on Day 7.
16224202|NCT01206517|Drug|Asenapine 5 mg|Asenapine tablet, SL, 5 mg b.i.d. on Days 1-6 and one 5 mg tablet, SL, on Day 7.
16224203|NCT01206517|Drug|Asenapine 10 mg|Asenapine tablets, SL, in a rising dose schedule to 10 mg b.i.d. (with a single 10 mg dose on final day). For Cohorts 3b, 3c and 3d, rising dose schedule begins with asenapine 5 mg b.i.d. on Day 1 and dosing occurs through Day 8. For Cohort 3a, rising dose schedule begins with asenapine 2.5 mg b.i.d. on Day 1 and dosing occurs through Day 12.
16224204|NCT01206504|Biological|MGAWN1|Humanized monoclonal to West Nile virus. Dose=30mg/kg
16224205|NCT01206478|Drug|Amitriptyline|Amitriptyline 1 mg/kg once daily at bedtime.
16224206|NCT01206478|Drug|Placebo|Placebo (looks like study drug but has no active ingredients) once daily at bedtime.
16224207|NCT01206478|Drug|Megestrol|At Visit 2, after participating in the study for ten weeks, children will receive a prescription for the appetite stimulant megestrol. The dose each child will receive depends on their age and weight. The dose of megestrol is 6 mg/kg divided into two doses per day.
16224208|NCT01206465|Drug|pralatrexate|Given IV
16224209|NCT01206465|Drug|fluorouracil|Given IV
16224210|NCT01206465|Other|laboratory biomarker analysis|Correlative studies
16224211|NCT01206465|Genetic|DNA analysis|Correlative studies
16224212|NCT01206465|Other|high performance liquid chromatography|Correlative studies
16224213|NCT01206465|Genetic|polymerase chain reaction|Correlative studies
16224214|NCT01206465|Genetic|nucleic acid sequencing|Correlative studies
16224215|NCT01206465|Other|pharmacological study|Correlative studies
16224216|NCT01206465|Other|pharmacogenomic studies|Correlative studies
16224217|NCT01206465|Genetic|polymorphism analysis|Correlative studies
16224218|NCT01206452|Drug|Prednisone|60mg of oral prednisone 2 days before procedure, day of procedure, and 1 day after procedure
16224219|NCT01206452|Other|Placebo|60mg placebo pill given 2 days before procedure, day of procedure, and 1 day after procedure
16224220|NCT01206452|Procedure|Ablation Procedure|Atrial Fibrillation (AF) ablation
16224221|NCT01206439|Drug|nebivolol|nebivolol 5 or 10 mg oral, daily
16224222|NCT01206413|Dietary Supplement|Low glycemic index diet|
16224223|NCT01206413|Dietary Supplement|High glycemic index diet|
16224224|NCT01206413|Other|Home-based exercise intervention|
16224225|NCT01206413|Other|Non-exercisers|
16224226|NCT01206387|Drug|Desoximetasone Spray 0.25%|Desoximetasone topical spray 0.25% administered to affected area twice a day for 28 days
16224227|NCT01206387|Drug|placebo comparator|Placebo administered to affected area twice a day for 28 days
16224228|NCT01206361|Drug|XALACOM|Xalacom eye drops
16224229|NCT01206361|Drug|Duotrav|Duotrav eye drops
16224230|NCT01206361|Drug|Ganfort|Ganfort eye drops
16224231|NCT01206348|Drug|Minocycline, Clindamycin, Tretinoin, Benzoyl Peroxide|Solodyn 1 tablet, Q day Ziana Gel, topical Q am Triaz FC, topical Q night
16224232|NCT01206335|Drug|OHR/AVR118|OHR/AVR118 given subcutaneously at 4mL per day
16224233|NCT01206322|Drug|Intranasal insulin|The acute effects of a single 40-IU dose of intranasal insulin
16224234|NCT01206322|Drug|Placebo|The acute effects of intranasal sterile saline.
16224235|NCT01206296|Drug|Intraperitoneal Gemcitabine|"Standard pancreatic resection followed by heated intraoperative intraperitoneal gemcitabine 1000 mg/m2
~Adjuvant intraperitoneal gemcitabine treatments (days 1, 8 and 15 of each 4-week cycle) for 6 cycles"
16224236|NCT01206283|Procedure|Modified Lund concept|"After surgical evacuation of intracranial mass lesion and clipping of aneurysm the objectives were achieved:
~Reduction of cerebral energy metabolism with fentanyl (2-5 µg/kg/h) and thiopenthal (0.5-3 mg/kg/h);
~Maintenance of colloid osmotic pressure with administration of red cell and albumin/plasma transfusions to maintain Hb/s 125-140 g/L and Alb/s ≈40 g/L;
~Reduction of capillary hydrostatic pressure with α2-agonist clonidine (0.4-0.8 µg/kg, 1 x 4-6 iv.) and maintaining normovolaemia;
~Reduction of mean arterial pressure and neuroprotection with Nimodipine infusion 5 ml per hour for 21 days and Urapidil 200 mg /200 ml, 7-10 ml/h.
~Control of ICP, which can be in majority of patients, kept at values below 15 mmHg."
16224237|NCT01206283|Procedure|Cerebral perfusion pressure-targeted therapy|"ICP monitoring using an external ventricular drain and CSF drainage as a first measure if ICP was increased (over 15-20 mmHg);
~Maintenance of CPP over 70-80 mmHg (Triple 'H' therapy = 3L/24 hours including 1L of colloids - 5% albumin; drugs = dopamine, dobutamine);
~No hyperventilation if ICP was under 20-25 mmHg and hyperventilation as a third measure if ICP was increased;
~Osmotherapy (20% manitol, bolus 150-350 ml or 10% manitol, 50 ml/h for 10 hours and standard electrolytes [Na, Cl and K]);"
16224238|NCT01206270|Drug|Testosterone undecanoate|Testosterone undecanoate 1000mg (in 4 ml of castor oil injections) at baseline (0-week), 6-week, 18-week, 30-week
16224239|NCT01206270|Drug|Castor Oil|4 ml of Castor Oil injected at baseline (0-week), 6-week, 18-week, 30-week.
16224240|NCT01206257|Drug|Iopromide (Ultravist, BAY86-4877)|Intravenous/intraarterial digital subtraction angiography (DSA); Generally doses of up to 1.5 g iodine per kg body weight are well tolerated.
16224241|NCT01206218|Drug|FLOT Regimen|FLOT Regimen: 5-fluorouracil, Oxaliplatin, Docetaxel
16224242|NCT01206218|Drug|FLO Regimen or FLOT Regimen|FLO Regimen: 5-fluorouracil, Oxaliplatin FLOT Regimen: 5-fluorouracil, Oxaliplatin, Docetaxel
16224243|NCT01206205|Drug|Lenalidomide, Bortezomib|"Induction:
~3 cycles of 21 days of Dexamethasone : 40 mg/j, days 1, 8 et 14 Bortezomib (Velcade®) : 1,3 mg/m2/d, days 1, 4, 8, et 11 Lenalidomide (Revlimid®) :25 mg/d, days 1 to 14
~Consolidation (2 months After ASCT):
~2 cycles of 21 days of Lenalidomide (Revlimid®) 25 mg/j, days 1 à 14 Bortezomib (Velcade®) 1,3 mg/m2/d, days 1, 4, 8, et 11 Dexamethasone 40 mg/j, days 1, 8 et 14
~Maintenance Phase:
~3 to 8 weeks after consolidation. Cycle length: 28 days Lenalidomide (Revlimid®) 10 mg/d until 12 months"
16224244|NCT01206179|Biological|cell injection|Injection of mesenchymal cells in fractured zone
16224245|NCT01206166|Drug|Olimel (5.7%E / N9E)|OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.
16224246|NCT01206153|Drug|metformin|
16224247|NCT01206140|Other|Laboratory Biomarker Analysis|Correlative studies
16224248|NCT01206140|Drug|Selumetinib|Given PO
16224249|NCT01206140|Drug|Temsirolimus|Given IV
16224250|NCT01206127|Other|Postoperative positioning: Bed rest|Patients in this group should be lying down facing up 2 hours postoperatively
16224251|NCT01206127|Other|Postoperative positioning: Sitting up|Patients in this group should be sitting up in a chair 2 hours postoperative
16224252|NCT01206114|Other|Follow-up|Questionnaires, interviews, nasal/oral and serum samples, register data
16224253|NCT01206114|Other|Follow-up|Questionnaires, interviews, nasal/oral and serum samples, register data
16224254|NCT01206101|Drug|liraglutide|Dose escalation of liraglutide up to 1.2 to 1.8 mg before islet cell transplant until the planned number of transplanted subjects is complete or subject is transplanted. After islet cell transplant, subjects continue to receive the reached liraglutide dose for 52 weeks. Injected subcutaneously(under the skin) once daily.
16224255|NCT01206101|Drug|placebo|Dose escalation escalation of liraglutide up to 1.2 to 1.8 mg before islet cell transplant until the planned number of transplanted subjects is complete or subject is transplanted. After islet cell transplant, subjects continue to receive the reached liraglutide placebo dose for 52 weeks. Injected subcutaneously (under the skin) once daily.
16224256|NCT01206088|Drug|nilotinib|administration of nilotinib as 2nd line
16224257|NCT01206075|Drug|Mozobil|Previously mobilized splenectomized patients who failed to yield sufficient numbers of cells with Mozobil alone will receive low doses G-CSF subcutaneously (starting at 2.5µg/kg/day and adjusted to the degree of leukocytosis), and Mozobil at 240µg/kg starting on the 4th or 5th day of G-CSF, followed by one to three leukaphereses. Previously non-splenectomized patients who failed to yield sufficient numbers of cells with Mozobil alone will receive G-CSF at 10µg/kg/day subcutaneously for 4-7 days, and Mozobil at 240µg/kg starting on the 4th or 5th day of G-CSF, followed by one to three leukaphereses.
16224258|NCT01206075|Drug|Mozobil|Previously mobilized splenectomized patients who failed to yield sufficient numbers of cells with G-CSF in the previous study will receive low doses G-CSF subcutaneously (starting at 2.5µg/kg/day and adjusted to the degree of leukocytosis), and Mozobil at 240µg/kg starting on the 4th or 5th day of G-CSF, followed by one to three leukaphereses. Previously non-splenectomized patients who failed to yield sufficient numbers of cells with G-CSF in the previous study will receive G-CSF at 10µg/kg/day subcutaneously for 4-7 days, and Mozobil at 240µg/kg starting on the 4th or 5th day of G-CSF, followed by one to three leukaphereses.
16224259|NCT01206075|Drug|Mozobil|Up to sixteen patients (splenectomized and non-splenectomized) who were not previously mobilized will receive Mozobil at 240µg/kg for one to three days, followed by one to three leukaphereses.
16224260|NCT01206062|Drug|Intensive control of SBP|"Participants in the Intensive arm have a goal of SBP <120 mm Hg. Use of once-daily antihypertensive agents will be encouraged unless alternative frequency is indicated/necessary. One or more medications from the following classes of agents will be provided by the study for use in managing participants in both randomization groups to achieve study goals:
~Angiotension converting enzyme (ACE)-inhibitors Angiotension receptor blockers (ARBs) Direct vasodilators Thiazide-type diuretics Loop diuretics Potassium-sparing diuretics Beta-blockers Sustained-release calcium channel blockers (CCBs) Alpha1-receptor blockers Sympatholytics
~Combination products will be available, depending on cost, utility, or donations from pharmaceutical companies."
16224261|NCT01206062|Drug|Standard control of SBP|Participants in the Standard BP arm have a goal of SBP <140 mm Hg. The same medications used in the Intensive BP arm will be used for the Standard BP arm.
16224262|NCT01206049|Drug|Gemcitabine|1,000 mg/m2 on day 1 of a 2 weeks cycle
16224263|NCT01206049|Drug|Oxaliplatin|60 mg/m2 on day 1 of a 2 weeks cycle
16224264|NCT01206049|Drug|Capecitabine|1,000 mg/m2 x 2 daily on days 1-7 of a 2 weeks cycle
16224265|NCT01206049|Drug|Panitumumab|6 mg/kg on day 1 of a 2 weeks cycle
16224266|NCT01206049|Drug|Bevacizumab|10 mg/kg on day 1 of a 2 weeks cycle
16224267|NCT01206036|Drug|Docetaxel|DL 1: Docetaxel 60mg/m^2, Temsirolimus 15mg. DL 2: Docetaxel 60mg/m^2, Temsirolimus 25mg. DL 3: Docetaxel 75mg/m^2, Temsirolimus 25mg. One cycle is defined as a 3 week period (21 days) where docetaxel is given on day 1, and temsirolimus on days 1, 8 and 15.
16224268|NCT01206036|Drug|Temsirolimus|DL 1: Docetaxel 60mg/m^2, Temsirolimus 15mg. DL 2: Docetaxel 60mg/m^2, Temsirolimus 25mg. DL 3: Docetaxel 75mg/m^2, Temsirolimus 25mg. One cycle is defined as a 3 week period (21 days) where docetaxel is given on day 1, and temsirolimus on days 1, 8 and 15.
16224269|NCT01206023|Other|NA-NOSE artificial olfactory system|NA-NOSE is an artificial olfactory system that is based on nanomaterials and connected with machine learning. NA-NOSE can diagnosis diseases or disorders based on volatile biomarkers that are emitted from exhaled breath, blood, or from clinical tissue.
16224270|NCT01206010|Drug|Varenicline|Participants will increase varenicline dose by 0.5 mg twice daily every three days to a maximum of 2.5 mg twice daily. This increased dose will be continued for 3-weeks before being reduced to the standard dose of 1.0 mg twice daily.
16224271|NCT01206010|Drug|Placebo|Participants will increase placebo dose by 0.5 mg twice daily every three days to a maximum of 2.5 mg twice daily. This increased dose will be continued for 3-weeks before being reduced to the standard varenicline dose of 1.0 mg twice daily.
16224272|NCT01206010|Drug|Varenicline|All participants will receive the standard dose of Varenicline (14 weeks): 0.5 mg once daily for days 1-3, 0.5 mg twice daily for days 4-7, and then a continuation dose of 1.0 mg twice daily. In addition to this participants will use an tailored varenicline/placebo dose up to maximum of 2.5 mg twice daily for 3 weeks.
16224273|NCT01205997|Drug|Fentanyl|Ninety patients 20-60 yr old American Society of Anesthesiologists ( ASA) physical status I or II, scheduled for femur surgery under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of three groups of 30 each. The magnesium group (groupM) received bupivacaine 15mg combined with 0.5ml magnesium 10%,The fentanyl group (group F) received bupivacaine 15mg combined with0.5 ml fentanyl[25microgram] and The placebo group (group P) received bupivacaine 15mg combined with 0.5ml distilled water(intrathecally) for each three groups 5 minutes prior to surgery)
16224274|NCT01205997|Drug|placebo(distilled water)|Ninety patients 20-60 yr old American Society of Anesthesiologists ( ASA) physical status I or II, scheduled for femur surgery under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of three groups of 30 each. The magnesium group (groupM) received bupivacaine 15mg combined with 0.5ml magnesium 10%,The fentanyl group (group F) received bupivacaine 15mg combined with0.5 ml fentanyl[25microgram] and The placebo group (group P) received bupivacaine 15mg combined with 0.5ml distilled water(intrathecally) for each three groups 5 minutes prior to surgery)
16224275|NCT01205997|Drug|magnesium sulphate|Ninety patients 20-60 yr old American Society of Anesthesiologists ( ASA) physical status I or II, scheduled for femur surgery under spinal anesthesia, were studied in a prospective, double-blinded, randomized way. The patients were randomly allocated to one of three groups of 30 each. The magnesium group (groupM) received bupivacaine 15mg combined with 0.5ml magnesium 10%,The fentanyl group (group F) received bupivacaine 15mg combined with0.5 ml fentanyl[25microgram] and The placebo group (group P) received bupivacaine 15mg combined with 0.5ml distilled water(intrathecally) for each three groups 5 minutes prior to surgery)
16224276|NCT01205984|Drug|methylprednisolone|Patients enrolled in the study were given either oral amoxicillin/clavulanate (AMX/C) or metylprednisolone (MP) (group MP) or AMX/C and placebo (group P) twice daily using a random allocation chart based on a table of random numbers. Oral AMX/C was administered 45/6.4 mg/kg/d (maximum 2000/285 mg/d) for 30 days for both groups. Oral MP was administered for the first 15 days: 1 mg/kg/d (maximum 40 mg/d) for 10 days, 0.75 mg/kg/d for 2 days, 0.5 mg/kg/d for 2 days, and 0.25 mg/kg/d for 1 day. Placebo tablets contained lactose and were of same size and color as MP tablets.
16224277|NCT01205971|Behavioral|Motivational Interviewing|Motivational interviewing is delivered by trained public housing residents, every 3 months for a total of 8 sessions over 24 months.
16224278|NCT01205971|Behavioral|Dental Preventive Services|Written oral health educational materials
16224279|NCT01205958|Procedure|acupuncture|Over an three-week period, one group(n=15) gets western medicine treatment(drug medication); another group(n=15) gets oriental medicine treatment(individualized needling 2-3 times a week); the other group(n=15) gets western medicine plus oriental medicine treatment for 3 weeks
16224280|NCT01205932|Drug|Rivaroxaban (BAY59-7939)|Daily dose: 5mg/day (5mg, once daily) for 34 to 35 days (±4 days)
16224281|NCT01205932|Drug|Rivaroxaban (BAY59-7939)|Daily dose: 7.5mg/day (7.5mg, once daily) for 34 to 35 days (±4 days)
16224282|NCT01205932|Drug|Rivaroxaban (BAY59-7939)|Daily dose: 10mg/day (10mg, once daily) for 34 to 35 days (±4 days)
16224283|NCT01205932|Drug|Enoxaparin|daily dose: 40mg/day (20mg each, twice daily) for 6 to 7 days (±2 days)
16224284|NCT01205919|Behavioral|Internet-based guided self-help for tinnitus|Internet-based guided self-help for tinnitus: provided via Internet, duration of 10 weeks
16224285|NCT01205919|Other|Internet discussion forum|Tinnitus-specific internet discussion forum over 10 weeks (no therapeutic intervention)
16224286|NCT01205906|Behavioral|Internet-based guided self-help for tinnitus|Internet-based self-help for tinnitus: provided via Internet, duration of 10 weeks
16224287|NCT01205906|Behavioral|Cognitive-behavior group therapy for tinnitus|Cognitive-behavior group therapy for tinnitus: weekly group sessions of 90 minutes, duration of 10 weeks
16224288|NCT01205906|Other|Internet discussion forum|Tinnitus-specific internet discussion forum over 10 weeks (no therapeutic intervention)
16224289|NCT01205893|Device|Neovasc Reducer|Implantation of the Reducer
16224290|NCT01205893|Device|Control|Control - No device implanted
16224291|NCT01205880|Drug|Calcitriol ointment|twice daily
16224292|NCT01205880|Drug|Clobetasol spray|twice daily
16224293|NCT01205867|Drug|AZD8848|Nasal spray solution, intranasal, single ascending doses, 1.4 - 60 μg
16224294|NCT01205854|Device|Ultrasonography|Standardized ultrasonographic assessment of 32 joints, assessed for both grey scale synovitis and power doppler signal, at each visit. Dose escalations based on DAS response in combination with change in US score. All joints with US Power Doppler signal are targets for intra articular injections.
16224295|NCT01205841|Procedure|Ottawa Ankle and Foot Rules|As previously published
16224296|NCT01205841|Procedure|Buffalo Rule|As previously published
16224297|NCT01205841|Procedure|Ottawa Ankle and Foot Rules + application of a tuning fork to the distal fibula and tibia|As previously published
16224298|NCT01205841|Procedure|Thompson Test|As previously published
16224299|NCT01205841|Procedure|Palpation of the fibula|Palpation of the fibula over its entire length.
16224300|NCT01205841|Procedure|Ottawa Ankle and Foot Rules + palpation of the cuboid bone|As previously published
16224301|NCT01205841|Procedure|Ottawa Ankle and Foot Rules + palpation over the deltoid ligament|As previously published
16224302|NCT01205841|Procedure|Malleolar Zone Algorithm|As previously published
16224303|NCT01205841|Procedure|Low Risk Exam|As previously published
16224304|NCT01205841|Procedure|Bernese Ankle Rules|As previously published
16224305|NCT01205841|Procedure|Ottawa Ankle and Foot Rules + swelling of the distal fibula|As previously published
16224306|NCT01205828|Drug|Temozolomide|Temozolomide 150 mg/m2/day PO Days 1-5 every 28 days
16224307|NCT01205828|Drug|ABT-888|ABT-888 40 mg BID PO Days 1-7 every 28 days
16224308|NCT01205815|Other|Tissue and blood collection|Tissue will be obtained from a previous biopsy if available, or if unavailable, tissue will be collected from a scheduled biopsy. About3-4 teaspoons of blood will be collected.
16224309|NCT01205802|Procedure|MHV reconstruction|MHV reconstruction with PTFE or homograft
16224310|NCT01205776|Device|Percutaneous Coronary Intervention|Those patients receiving the XIENCE PRIME™ EECSS or XIENCE V® EECSS or XIENCE Xpedition™ EECSS or XIENCE PRO EECSS
16224311|NCT01205776|Procedure|CABG|Those patients receiving CABG
16224312|NCT01205750|Other|Glucose clamp|450 min hyperinsulinemic euglycemic glucose clamp, 0,5 mU / kg lean body mass / min
16224313|NCT01205737|Biological|TL011|375 mg/m2 iv every 3 weeks for 8 cycles
16224314|NCT01205737|Biological|Rituximab|375 mg/m2 iv every 3 weeks for 8 cycles
16224315|NCT01205724|Drug|turoctocog alfa pegol|Single dose (low) administered intravenously (into the vein)
16224316|NCT01205724|Drug|turoctocog alfa pegol|Single dose (medium) administered intravenously (into the vein)
16224317|NCT01205724|Drug|turoctocog alfa pegol|Single dose (high) administered intravenously (into the vein)
16224318|NCT01205711|Drug|FOLFIRI regimen|
16224319|NCT01205711|Drug|fluorouracil|
16224320|NCT01205711|Drug|irinotecan hydrochloride|
16224321|NCT01205711|Drug|leucovorin calcium|
16224322|NCT01205711|Drug|zibotentan|
16224323|NCT01205711|Other|laboratory biomarker analysis|
16224324|NCT01205711|Other|pharmacogenomic studies|
16224325|NCT01205698|Other|Nutritional drink|
16224326|NCT01205685|Drug|OSI-906|"In a pill form by mouth, twice a day (12 hours apart)
~During the safety run portion of the study
~Dose level 2 = 150 mg twice a day
~Dose level 1 = 100 mg twice a day
~Dose level -1 = 100 mg twice a day
~Dose level -2 = 100 mg twice a day"
16224327|NCT01205685|Drug|Erlotinib|"During the safety run phase of the study:
~Dose Level 2 = 100 mg/d
~Dose Level 1 = 100 mg/d
~Dose Level -1= 75 mg/d
~Dose Level -2 = 50 mg/d"
16224328|NCT01205685|Drug|Letrozole|In a pill form, by mouth, once per day at 2.5 mg/d.
16224329|NCT01205685|Drug|Goserelin|For pre-menopausal patients only. Given as an injection once a month at 3.6 mg/month.
16224330|NCT01205672|Drug|Metformin|850 mg by mouth once daily for at least 7 days, and up to 30 days before surgery.
16224331|NCT01205646|Drug|zoledronate therapy|Zometa will be administered at a dose of 4mg IV over 15 minutes. A third PET scan will be obtained within 1-2 weeks after Zometa administration. Intravenous (through a vein in the arm) infusion every four weeks. Dose will be determined by kidney function.
16224332|NCT01205646|Device|PET Scan|2 scans [about 1-2 weeks apart] will be obtained over a period of 2 weeks pretherapy to confirm reproducibility.A third PET scan will be obtained within 1-2 weeks after Zometa administration.
16224333|NCT01205633|Procedure|venous angioplasty|catheter venous angioplasty via femoral vein approach
16224334|NCT01205620|Device|ITPR|• Upon incision of the pericardium the -9 mmHg ITPR device will be applied to the patient's endotracheal tube (in the ITPR randomized group).
16224335|NCT01205620|Other|No intervention|No intervention will be performed in the control group
16224336|NCT01205607|Device|ITPR -5 mm Hg then -9 mm Hg|the ITPR will be inserted in the ventilator circuit and activated to provide either -5 mm Hg or -9 mm Hg endotracheal tube pressure (ETP) Each subject will have all measurements recorded at both -5 & -9 mm Hg
16224337|NCT01205607|Device|ITPR -9 & then -5mm Hg|the ITPR will be inserted in the ventilator circuit and activated to provide either -5 mm Hg or -9 mm Hg endotracheal tube pressure (ETP) Each subject will have all measurements recorded at both -5 & -9 mm Hg
16224338|NCT01205594|Device|ITPR|the ITPR will be inserted in the anesthesia circuit and activated to provide -10 mmHg ETP.
16224339|NCT01205581|Biological|Fluzone High Dose Vaccine|Two doses of Fluzone HD will be administered to children with leukemia, solid tumor, or HIV.
16224340|NCT01205581|Biological|Fluzone Standard Dose Vaccine|Two doses of Fluzone Standard Dose Vaccine will be administered to children with leukemia, solid tumor, or HIV.
16224341|NCT01205568|Device|Transcatheter Cutting Balloon therapy|
16224342|NCT01205568|Procedure|High Pressure Balloon Angioplasty|
16224343|NCT01205555|Device|urine LH testing|"The study group will start urine LH (LHu) testing according to the mean diameter of the leading follicle on ultrasound as per :
~13mm or less - Repeat ultrasound scan in 1-2 days 14-17mm - start urine LH testing the evening of the day of the scan 18mm or greater - do one LHu test in the afternoon of the day of the scan before HCG administration Once the patient has commenced LHu testing she will perform 2 tests per day. The tests will be performed at 7am and 7pm. LHu testing will continue until the time of HCG administration or positive uLH.If the LHu result is positive either in the morning or afternoon, the insemination will be the next morning without the administration of exogenous HCG.
~If the patient has an inconclusive LHu result, a blood LH test will be taken. If the LH blood test is negative (<8 IU\L) she will continue testing LHu. If the LH blood test is positive (≥ 8 IU\L) the insemination will be the next day."
16224344|NCT01205542|Behavioral|Training|Training of scapular function with strengthening exercises using bodyweight and elastic resistance
16224345|NCT01205542|Behavioral|Reference|Health check and advice to continue ordinary physical activity
16224346|NCT01205529|Drug|Procainamide|One time intravenous infusion of Procainamide administered over 30 minutes. Dosage is calculated as 10mg/kg based on subject's ideal body weight.
16224347|NCT01205516|Drug|Methadone|Patients in the methadone arm will be supplied with 2.5 mg tablets. The dose will consist of 1-12 tablets taken twice daily, every 12 hours (range 5-60 mg per 24 hours).
16224348|NCT01205516|Drug|Controlled Release Morphine|controlled release morphine supplied in 10 mg tablets, 1-12 tablets taken twice daily, every 12 hours (range 20-240 mg per 24 hours).
16224349|NCT01205503|Drug|Mesna|Mesna: 360 mg/m2 in 50 mL normal saline (NS) either on cycle 2 or cycle 1, day 1. Infused over 15 minutes
16224350|NCT01205503|Drug|Saline|Saline (used as a placebo) infused over the same time as mesna intervention
16224351|NCT01205503|Drug|Doxorubicin|60mg/m2 given IV over 15 minutes after receiving mesna or saline. Can allow for premedications of Ondansetron 8 mg orally, dexamethasone 12 mg orally, Aprepitant 125 mg orally.
16224352|NCT01205503|Drug|Cyclophosphamide|600 mg/m2 IV over 30 minutes. Start 6 hours after doxorubicin started.
16224353|NCT01205490|Other|head positions and spinal manipulation|Each subject will then undergo a baseline MRI in a head neutral position (0 degrees rotation). They will then be placed in head rotation (45 degrees) to the non-dominant and undergo a MRI. Maximum rotation to the side with MRI will follow. Finally, each subject will receive an upper cervical rotary manipulation to the non-dominant side with MRI immediately after. A total of 4 test conditions will be evaluated (rest, 45 degree, maximal, post-manipulation). The manipulation will be performed by an experience practitioner on a bed just outside the MRI room in supine position. A controlled impulse load will be applied and the head/neck returned to neutral position. Prior to each maneuver, the subject will be queried on their comfort, condition and willingness to continue
16224354|NCT01205477|Drug|EXPERIMENTAL|Infiltration of 40 mg of methylprednisolone acetate plus 1 mL of xylocaine and Diclofenac sodium 100 mg PO QD for 10 days
16224355|NCT01205477|Drug|PLACEBO|Infiltration of 1 mL of xylocaine and Diclofenac sodium 100 mg PO QD for 10 days
16224356|NCT01205464|Drug|Doxycycline|Doxycycline, 100 mg, 2 capsules once daily, 24 hour time interval, 21 days.
16224357|NCT01205464|Drug|Placebo|Placebo, 100 mg, 2 capsules once daily, 24 hour dosage interval, 21 days.
16224358|NCT01205451|Drug|Botulinum toxin type A|Botulinum toxin type A
16224359|NCT01205438|Drug|LY2127399|120mg administered via subcutaneous injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug
16224360|NCT01205438|Drug|Placebo every 2 weeks|Administered via subcutaneous injection for 52 weeks. A matching loading dose will also be administered at the first dose.
16224361|NCT01205438|Drug|Placebo every 4 weeks|Administered via subcutaneous injection for 52 weeks.
16224362|NCT01205425|Other|PCI on the basis of coronary angiography|Interventional cardiologist will be blinded to the images obtained by CT. The PCI procedure will be planned and performed solely on the basis of invasive coronary angiography
16224363|NCT01205425|Procedure|CT guided PCI|The results of the CT scan will be analysed by the interventional cardiologist that is to perform angiography and PCI. Based on this analysis preliminary procedural strategy is planned (stent diameters, decision on direct stenting vs. predilatation, decision on postdilation)
16224364|NCT01205412|Procedure|Endocervical samples|Endocervical samples collection during routine gynaecological examinations
16224365|NCT01205386|Device|1. CROSSER System|The Crosser system will be used to recanalize the chronic total occlusion in the SFA (superficial femoral artery). The IVUS (Intravascular Ultrasound Imaging) System will be used in the treated occlusion after the Crosser to generate real-time images of the artery.
16224366|NCT01205373|Drug|BI 671800|High dose oral drinking solution
16224367|NCT01205360|Drug|Bupivacaine-Fentanyl Mixture|Three millilitres of mixture of bupivacaine (0.125%) with fentanyl (2 µg/ml) injected through epidural catheter every 15 minutes as automated boluses.
16224368|NCT01205360|Drug|Bupivacaine-Fentanyl Mixture|Four millilitres of mixture of bupivacaine (0.125%) with fentanyl (2 µg/ml) injected through epidural catheter every 20 minutes.
16224369|NCT01205360|Drug|Bupivacaine-Fentanyl Mixture|Six millilitres of mixture of bupivacaine (0.125%) with fentanyl (2 µg/ml) injected through epidural catheter every 30 minutes.
16224370|NCT01205347|Drug|Simvastatin 80mg|Simvastatin 80mg once a day
16224371|NCT01205347|Drug|Simvastatin 10mg|Simvastatin 10mg once a day
16224372|NCT01205334|Biological|Autologous CMV-specific CTL|"CMV-specific T cells will be given by intravenous injection over 1-10 minutes through either a peripheral or a central line with a minimum 20g cannula. The expected volume will be 1-50 cc.
~At the discretion of the attending physician, subjects can receive repeat infusions of modified T cells at the same dose level as long as they do not have progressive disease (up to a maximum of 6 doses and the minimum interval between repeat infusions is 6 weeks). Infusion procedures and follow-up will be identical to those for the first infusion. Patients, who receive additional doses of CTLs will be monitored exactly like after the 1st CTL infusion."
16224373|NCT01205321|Drug|Bombesin (68Ga) labeled (BAY86-7548)|Cancer patients, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, PET/CT
16224374|NCT01205321|Drug|Bombesin (68Ga) labeled (BAY86-7548)|Healthy volunteers, single intravenous bolus injection of 140 MBq BAY86-7548 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY86-7548 in blood
16224375|NCT01205308|Dietary Supplement|Vegetable oil based margarine with plant stanol ester enrichment|3 g plant stanols/ day
16224376|NCT01205295|Other|Cognitive behavioural therapy|Cognitive behavioural therapy Psychologist Preoperative Efficacy of treatment
16224377|NCT01205282|Drug|Pioglitazone|A modified dose finding method will be used to determine safety and dose response among three dose levels (0.25mg/kg QD, 0.5mg/kg QD, and 0.75mg/kg QD). The dose has been based on the per weight maximum adult dose. Specifically, the FDA has approved 45mg as the maximum adult dose. For a 60kg adult, this is 0.75mg/kg. There will be 14 weeks of active treatment.
16224378|NCT01205282|Drug|Placebo|There will be a 2 week period of placebo run-in.
16224379|NCT01205269|Drug|AZD8683, 50 mcg|Dry powder for inhalation, single dose
16224380|NCT01205269|Drug|Placebo|Dry powder for inhalation, single dose
16224381|NCT01205269|Drug|AZD8683, 200 mcg|Dry powder for inhalation, single dose
16224382|NCT01205256|Drug|methadone|0.25mg/kg IV of racemic methadone at the induction of anesthesia.
16224383|NCT01205243|Drug|ZIAGEN®|Basically there is no treatment allocation. Subjects who would be administrated ZIAGEN® at their physician's discretion will be enrolled. Dosage regimen will be recommended according to the prescribing information. Subjects will be enrolled consecutively.
16224384|NCT01205230|Drug|pazopanib|Adenosine triphosphate (ATP)-competitive tyrosine kinase inhibitor of vascular endothelial growth factor receptor (VEGFR)-1, -2, and -3, platelet derivative growth factor receptor (PDGFR)
16224385|NCT01205217|Drug|Lapatinib|Lapatinib 1000 mg orally once daily continuously
16224386|NCT01205217|Drug|Trastuzumab|Part II (Week 13-24) Trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV Day 1 of each week
16224387|NCT01205217|Drug|Epirubicin|Part I (Week 1-12) Epirubicin 90 mg/m2 by IV infusion on Day 1 every 21 days
16224388|NCT01205217|Drug|Cyclophosphamide|Part I (Week 1-12) Cyclophosphamide 600 mg/m2 by IV infusion on Day 1 every 21 days
16224389|NCT01205217|Drug|Paclitaxel|Part II (Week 13-24) Paclitaxel 80 mg/m2 by IV infusion on Day 1 of each week
16224390|NCT01205204|Drug|Fentanyl|GROUP BF25 (CONTROL) In this group, patient will be given 2.0 mL of hyperbaric bupivacaine 0.5% with 25 mcg of fentanyl, intrathecally.
16224391|NCT01205204|Drug|Clonidine|In this group, patient will be given 2.0 mL of hyperbaric bupivacaine 0.5%with15 mcg of clonidine, intrathecally.
16224392|NCT01205204|Drug|Clonidine|In this group, patient will be given 2.0 mL of hyperbaric bupivacaine 0.5% with 30 mcg of clonidine, intrathecally.
16224393|NCT01205204|Drug|clonidine|In this group, patient will be given 2.0 mL of hyperbaric bupivacaine 0.5% with 60 mcg of clonidine, intrathecally.
16224394|NCT01205191|Behavioral|Cell-phone supported CBT|Cognitive behavioural therapy provided with all-time (ubiquitous) support by cell phone applications
16224395|NCT01205191|Behavioral|CBT with digital audio player support|Cognitive behavioural therapy provided with access to a digital audio player with self-administered materials for stress management and relaxation.
16224396|NCT01205191|Behavioral|CBT|CBT for anxiety disorders
16224397|NCT01205178|Drug|Chloroquine|The current gold standard for radical cure of P. vivax malaria in many areas of the world is chloroquine (CQ); typically 600 mg day 1, 600 mg day 2, 300 mg day 3 for clearance of the acute parasitemia. After this Tafenoquine will be given and subject will be followed up.
16224398|NCT01205178|Drug|Primaquine|Primaquine (PQ) is another 8 aminoquinoline drug available for Malaria treatment
16224399|NCT01205178|Drug|Tafenoquine|Once daily on Day 1 only. For Part B and C of this study Chloroquine will be given to treat Malaria
16224400|NCT01205165|Drug|Adefor dipivoxil|All enrolled subjects were enrolled to adefovir dipivoxil arm.
16224401|NCT01205152|Biological|asfotase alfa|
16224402|NCT01205139|Drug|TMC435|150 mg capsule once daily for 7 days
16224403|NCT01205139|Drug|TDF|300 mg tablet once daily for 7 days
16224404|NCT01205139|Drug|TMC435 + TDF|150 mg TMC435 capsule + 300 mg TDF tablet, once daily for 7 days
16224405|NCT01205139|Drug|TMC435 + TMC278|150 mg TMC435 capsule + 25 mg TMC278 tablet, once daily for 11 days
16224406|NCT01205139|Drug|TMC278|25 mg tablet once daily for 11 days
16224407|NCT01205139|Drug|TMC435|150 mg capsule once daily for 11 days
16224408|NCT01205126|Drug|Hydromorphone HCl|Hydromorphone HCl will be administered in dose of 8, 16, 24, and 32 milligram (mg), once daily for 2 to 8 days of Titration phase and 28 days of Maintenance phase. Starting dose will be based on participant's previous daily opioid dose.
16224409|NCT01205126|Drug|Oxycodone HCl CR|Oxycodone HCl will be administered in dose of 10, 20, 30 and 40 mg, twice daily for 2 to 8 days of titration phase and 28 days of maintenance phase. Starting dose will be based on participant's previous daily opioids dose.
16224410|NCT01205126|Drug|Placebo|Placebo will be administered to the participants receiving hydromorphone HCl or oxycodone HCl CR along with the study treatment to maintain necessary blinding.
16224411|NCT01205100|Behavioral|Bio-feedback|By providing on-line electromyography information of muscle activity, patients will be able to control and actively correct their muscle activity during the 15 min treatment session. Each patients will attend 3 treatment sessions.
16224412|NCT01205100|Drug|Placebo|
16224413|NCT01205087|Drug|OKT3|Oral anti-CD3 MAb will be administered at a dosage level of 0.2 or 1.0 or 5.0 mg per day for 30 days. Up of 9 patients will be treated at each dosage level, and up to additional 9 patients will receive placebo.
16224414|NCT01205074|Device|13C Methacetin Breath Test|
16224415|NCT01205074|Dietary Supplement|Grape fruit juice|
16224416|NCT01205074|Drug|Non selective beta blocker - Propranolol|
16224417|NCT01205074|Dietary Supplement|Ethanol|
16224418|NCT01205061|Device|Emervel Deep Lidocaine|20 mg/ml + 0.3% lidocaine
16224419|NCT01205061|Device|Juvederm® Ultra Plus|24 mg/ml
16224420|NCT01205048|Device|Emervel Classic Lidocaine|20 mg/ml + 0.3% lidocaine
16224421|NCT01205048|Device|Juvederm® Ultra|24mg/ml
16224422|NCT01205035|Drug|ranibizumab 2.0mg|Baseline monthly intravitreal injection of ranibizumab 2.0mg for 3 months followed by possible monthly injections up to 9 additional injections
16224423|NCT01205022|Drug|irinotecan hydrochloride|Given IV
16224424|NCT01205022|Drug|leucovorin calcium|Given IV
16224425|NCT01205022|Drug|fluorouracil|Given IV
16224426|NCT01205022|Biological|bevacizumab|Given IV
16224427|NCT01205022|Radiation|yttrium Y 90 DOTA anti-CEA monoclonal antibody M5A|Given IV
16224428|NCT01205022|Other|laboratory biomarker analysis|Correlative studies
16224429|NCT01205009|Drug|Ovitrelle|One dose of Ovitrelle 250 mcg
16224430|NCT01204996|Drug|CNTO888+DOXIL®/ Caelyx® doxorubicin HCl liposome injection|10 mg/kg CNTO 888 every 2 weeks plus DOXIL®/Caelyx® (doxorubicin HCl liposome injection) 50 mg/m2 every 4 weeks
16224431|NCT01204996|Drug|CNTO888 + gemcitabine|15 mg/kg CNTO 888 every 3 weeks plus gemcitabine 1000 mg/m2 administered on Days 1 and 8 of the 3-week cycle
16224432|NCT01204996|Drug|CNTO888 + Paclitaxel and carboplatin|15 mg/kg CNTO 888 every 3 weeks plus paclitaxel 175 mg/m2 and carboplatin dosed to AUC 6 every 3 weeks
16224433|NCT01204996|Drug|CNTO888 + docetaxel|15 mg/kg CNTO 888 every 3 weeks plus docetaxel 75 mg/m2 every 3 weeks
16224434|NCT01204957|Dietary Supplement|Seaweed and Soy Protein|5 g/d Seaweed for 6 wks, followed by 5 g/d Seaweed + Soy Protein for 1 wk
16224435|NCT01204957|Dietary Supplement|Placebo and Soy Protein|5 g/d Placebo for 6 wks, followed by 5 g/d Placebo + Soy Protein for 1 wk
16224436|NCT01204918|Drug|Riluzole|Riluzole 100mg PO
16224437|NCT01204918|Drug|placebo|placebo
16224438|NCT01204905|Drug|Raltegravir and Maraviroc in combination|"Raltegravir 400 mg tablet twice a day, ~12 hours (10 to 14 hours) apart
~Maraviroc 300 mg tablet twice a day, ~12 hours (10 to 14 hours) apart"
16224439|NCT01204892|Procedure|TAP Block|Patient will received bilateral ultrasound-guided TAP block with total of 30 ml of ropivacaine 0.5% after induction of general anesthesia
16224440|NCT01204892|Procedure|Local infiltration|20 ml of Ropivacaine 0.5% will be injected at port sites after induction of general anesthesia. 7 ml each for 10 mm ports, 3 ml each of 5 mm ports
16224441|NCT01204879|Behavioral|Contingency Management|Participants earn the chance to win prizes for the targeted behavior.
16224442|NCT01204866|Biological|Valortim and selected Components|"Valortim (Lot #10-08-001, 25 mg/mL) will be filtered through a 0.22 µm syringe filter and diluted 1:1000, 1:100, 1:10, and 1:1 in saline.
~Polysorbate 80 will be diluted in saline to the following concentrations: 0.06 mg/mL, 0.2 mg/mL, and 0.6 mg/mL.
~Mannitol (30 mg/mL) will be diluted in saline to the following concentrations: 1:1000, 1:100, 1:10, and 1:1
~Histamine (1 mg/mL), positive control
~Saline (0.9%), negative control"
16224443|NCT01204866|Drug|Valortim and Selected Components|"• It is anticipated that up to 4 subjects that received Valortim in a previous study (#0036-08-05) will participate in Stage II of the study; two of these subjects experienced adverse events while being dosed with Valortim. Subjects will each be tested percutaneously with Valortim, polysorbate 80, mannitol, histamine, and saline.
~Only one subject will be skin tested in a single day.
~The appropriate dilution for Valortim, mannitol, and polysorbate 80 will be based on the results from Stage I of this study. As was done in Stage I, Valortim will be filtered through a 0.22 µm syringe filter. Histamine (1 mg/mL) and saline (0.9%) will be used as the positive and negative controls, respectively"
16224444|NCT01204853|Drug|Sitaxentan|sitaxentan sodium 100 mg
16224445|NCT01204840|Drug|Growth Hormone|Subjects in this trial will use a 3.33mg vial (1 vial =10 IU) by daily subcutaneous injection. This will start on day 1 of the menstrual cycle preceding the stimulation phase of an IVF cycle, and will continue until the day of the human chorionic gonadotropin (hCG) trigger (approximately 5-6 weeks)
16224446|NCT01204840|Drug|Patch protocol|"Group A (n=10; control group) will receive patch protocol: 100ug estrogen patch (Estradot), Gonadotropin releasing hormone (GnRH) antagonist (Cetrotide; 0.25mg/d), gonadotropin stimulation 412 IU recombinant follicle stimulating hormone (r-FSH; Gonal F) and 150 IU of recombinant luteinizing hormone (r-LH; Luveris). With 3 or more follicles at mean diameter equal to or greater than 17mm, urinary human chorionic gonadotropin (u-hCG) 10,000 IU self-injected to complete final maturation of oocytes. Egg retrieval will occur 36 hours after hCG injection. Eggs fertilized by standard IVF or intra-cytoplasmic sperm injection (ICSI) depending on semen parameters. Embryos cultured to day 2 and the best 2-4 will be transferred back under ultrasound guidance. Surplus embryos will be frozen as per clinic protocol. Luteal support: Endometrin 100mg vaginally three times daily, starting on the day of egg retrieval and continuing until menses or positive serum beta-hCG, then stopped."
16224447|NCT01204827|Device|13C Methacetin Breath Test (BreathID)|
16224448|NCT01204801|Device|Focused Microwave Thermotherapy|Anthracycline Doxorubicin 60mg/m2 (or Epirubicin 100 mg/m2) + Standard of Care chemotherapy and drugs + Thermotherapy. Thermotherapy at first 3 chemotherapy treatments for Anthracycline chemotherapy nominally every 21±7 days plus Standard of Care chemotherapy. (A targeted tumor temperature of 44ºC (plus or minus 1.5ºC) and a targeted thermal dose of 80 equivalent treatment minutes (plus or minus 20 treatment minutes)). In the event that the targeted minimum cumulative thermal dose of 180 equivalent treatment minutes is not achieved in the first three treatments, an optional fourth thermotherapy treatment may be administered in combination with the fourth course of Anthracycline and standard of care chemotherapy. Standard of care (including breast imaging, drugs, and radiation) will be provided to all eligible subjects during and following the above study treatments.
16224449|NCT01204801|Drug|Chemotherapy (control)|Anthracycline Doxorubicin 60mg/m2 (or Epirubicin 100 mg/m2) + Standard of Care chemotherapy and drugs. Anthracycline chemotherapy nominally every 21±7 days. Standard of care (including breast imaging, drugs, and radiation) will be provided to all eligible subjects during and following the above study treatments.
16224450|NCT01204788|Procedure|Prophylactic White Cell Transfusion|Radiated white blood cell transfusions 2-3 times each week, or daily if infection develops
16224451|NCT01204788|Procedure|Therapeutic White Cell Transfusion|Radiated white blood cell transfusions daily only with infection (or persistent fever)
16224452|NCT01204775|Drug|Saxagliptin|Tablets, Oral, 2.5 mg or 5.0 mg (according to body weight category), Once Daily, 1-52 weeks
16224453|NCT01204775|Drug|Placebo (Saxagliptin)|Tablets, Oral, Once daily, 1-16 weeks
16224454|NCT01204775|Drug|Metformin IR|Tablets, Oral, 500 mg, Once Daily, 17-52 weeks
16224455|NCT01204775|Drug|Placebo (Metformin)|Tablets, Oral, Once daily, 1-16 weeks
16224456|NCT01204775|Drug|Metformin (Active Rescue)|Tablets, Oral, 500 mg, Titrated as needed, 2-52 weeks
16224457|NCT01204762|Drug|pegIFN|Syringe, Subcutaneous, 180 μg, Once Weekly, 48 weeks
16224458|NCT01204762|Drug|pegIFNα-2a|Syringe, Subcutaneous 180 μg, Once Weekly, 48 Weeks
16224459|NCT01204762|Drug|PegIFN lambda|Syringe, Subcutaneous, 180 µg, Once weekly, 48 weeks
16224460|NCT01204762|Drug|Entecavir|Tablet, Oral, 0.5 mg, Once daily, 12 weeks initial monotherapy followed by 48 weeks of combination therapy with PegIFN lambda
16224461|NCT01204749|Drug|AMG 386|Weekly Intravenous (IV) AMG 386 15 mg/kg
16224462|NCT01204749|Drug|AMG 386 Placebo|Weekly Intravenous (IV) placebo 15 mg/kg
16224463|NCT01204749|Drug|Paclitaxel|Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off)
16224464|NCT01204749|Drug|Paclitaxel|Paclitaxel 80 mg/m2 intravenous (IV) weekly (3 on/1 off)
16224465|NCT01204723|Drug|Placebo Aprepitant|Placebo Aprepitant 0 mg once daily for 5 days
16224466|NCT01204723|Drug|Active Aprepitant|Active Aprepitant 160 mg once daily for 5 days
16224467|NCT01204710|Biological|Olaratumab|15 milligrams per kilogram (mg/kg) intravenous (IV) Days 1 and 8
16224468|NCT01204710|Drug|Mitoxantrone|"Mitoxantrone 12 milligrams per square meter (mg/m²) IV Day 1
~Mitoxantrone is to be administered for up to 12 cycles (total cumulative dose of mitoxantrone is restricted to ≤144 mg/m²)"
16224469|NCT01204710|Drug|Prednisone|5 mg orally (PO) twice daily (BID) on each day
16224470|NCT01204697|Drug|docetaxel|75 mg/m2 intravenously every 3 weeks for 4 cycles
16224471|NCT01204697|Drug|erlotinib [Tarceva]|150 mg/day orally, days 2-16 each 3-week cycle for 4 cycles; 150 mg/day orally thereafter
16224472|NCT01204697|Drug|erlotinib [Tarceva]|150 mg/day orally as monotherapy
16224473|NCT01204684|Biological|autologous tumor lysate-pulsed DC vaccination|
16224474|NCT01204684|Biological|Tumor lysate-pulsed DC vaccination+0.2% resiquimod|
16224475|NCT01204684|Biological|Tumor-lysate pulsed DC vaccination +adjuvant polyICLC|
16224476|NCT01204671|Biological|Influenza vaccine GSK2321138A|One intramuscular injection
16224477|NCT01204671|Biological|FluarixTM|One intramuscular injection
16224478|NCT01204671|Biological|Influenza vaccine GSK2604409A|One intramuscular injection
16224479|NCT01204658|Biological|Pneumococcal vaccine GSK 2189242A (LD formulation 1)|Intramuscular injection
16224480|NCT01204658|Biological|Pneumococcal vaccine GSK 2189242A (HD formulation 2)|Intramuscular injection
16224481|NCT01204658|Biological|Synflorix|Intramuscular injection
16224482|NCT01204658|Biological|Prevenar 13|Intramuscular injection
16224483|NCT01204658|Biological|Infanrix Hexa (DTPa-HBV-IPV/Hib)|Intramuscular injection
16224484|NCT01204619|Behavioral|Intensive training group|an extra structured patient centric training program on PD technique and diet according to the developed training curriculum
16224485|NCT01204606|Procedure|Arthroscopic rotator cuff repair with intraoperative periarticular injection|"Under general anesthesia, the patient was placed in the lazy lateral decubitus position on the operating table.
~The surgical area was prepared and draped with Betadine.
~Small stab incisions were made in the creation of 4 or 5 portals as needed.
~A scope was explored via the arthroscopic portal into the GH joint & subacromial space.
~Repaired of rotator cuff tear was done with suture anchors.
~Mixed MMA drugs(ropivacaine 300mg;40ml, morphine 10mg;1ml, cefotetan 1g; dilution to ropivacaine, epinephrine 0.3mg;0.3ml, total volume:41.3ml) and sodium hyaluronate 20mg;2ml were injected divisionally periarticular area; intra-articular(sodium hyaluronate 20ml;2ml + 10.3ml); posterior joint capsule(10ml); subacromial space and around suprascapular nerve(11ml); anterior capsule(10ml).
~The skin was closed with Nylon or medical staples.
~Sterile dressing was applied on surgical wound.
~Peripheral intravenous PCA(Patient Controlled Analgesia) was connected."
16224486|NCT01204606|Procedure|Arthroscopic rotator cuff repair with non-injection of MMA drugs|"Under general anesthesia, the patient was placed in the lazy lateral decubitus position on the operating table.
~The surgical area was prepared and draped with Betadine.
~Small stab incisions were made in the creation of 4 or 5 portals as needed.
~A scope was explored via the arthroscopic portal into the GH joint & subacromial space.
~Repaired of rotator cuff tear was done with suture anchors.
~43.3ml of saline was injected divisionally periarticular area; intra-articular(12.3ml); posterior joint capsule(10ml); subacromial space and around suprascapular nerve(11ml); anterior capsule(10ml).
~The skin was closed with Nylon or medical staples.
~Sterile dressing was applied on surgical wound.
~Peripheral intravenous PCA(Patient Controlled Analgesia) was connected."
16224487|NCT01204593|Drug|INSULIN GLARGINE|Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: once a day at bedtime
16224488|NCT01204593|Drug|INSULIN GLULISINE|Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: three times a day, preferably just before the meal
16224489|NCT01204580|Drug|GLIMEPIRIDE + METFORMIN|Pharmaceutical form: film coated tablet Route of administration: oral Dose regimen: 1 tablet of 1/250 mg per day
16224490|NCT01204567|Other|Aerobic training|Group-based Aerobic Interval Training twice a week in 12 weeks, based on the Ulleval model. The Norwegian Ulleval Model is a group-based aerobic interval training program which is widely used in Scandinavian hospitals for patients with coronary disease. It is designed to improve physical capacity, body awareness and emotional well-being.
16224491|NCT01204554|Drug|Indocyanine green (ICG)|a water-soluble dye that binds to plasma proteins and remains in the intravascular space after intravenous injection.ICG has a normal plasma half life of 3-4 min. Dosage planned is 0 .5 mg/kg dose of ICG resolved in 5 % dextrose 2 mg /ml.
16224492|NCT01204528|Drug|Zemplar|Vitamin D receptor activator (VDRA)
16224493|NCT01204502|Biological|HSVTK retrovirally-transduced donor T lymphocytes|"HSVTK retrovirally-transduced donor T lymphocytes will be given at 1 month intervals, providing that there is no significant GVHD
~dose 1 5x104 cells/kg
~dose 2 5x105 cells/kg"
16224494|NCT01204489|Behavioral|Intensified dietary counseling at child wellfare clinics.|The intervention is completed by public health nurses who receive updating education in nutrition. A special training in a family-centred lifestyle counseling method in implemented. The nutrition intervention consists of tailored dietary counseling, information leaflets and self-evaluation card given to the families in the intervention arm. In the control clinics, public health nurses continue their usual dietary counseling.
16224495|NCT01204476|Biological|Cixutumumab|Given IV
16224496|NCT01204476|Drug|Everolimus|Given PO
16224497|NCT01204476|Other|Laboratory Biomarker Analysis|Correlative studies
16224498|NCT01204476|Drug|Octreotide Acetate|Given IM
16224499|NCT01204476|Other|Pharmacological Study|Correlative studies
16224500|NCT01204450|Drug|Temsirolimus|60-230mg/m2 weekly during each 28 day course, for up to 12 courses
16224501|NCT01204450|Drug|Valproic Acid|All patients will be given oral VPA (5 mg/kg, 3 times a day for each 28 day course, up to 12 courses
16224502|NCT01204437|Drug|Epirubicin, Cyclophosphamide|4 cycles of chemotherapy with epirubicin plus cyclophosphamide (EC) on day 1 q22
16224503|NCT01204437|Drug|Cyclophosphamide, Methotrexate, 5 FU|6 cycles CMF on days 1 and 8 q29 Cyclophosphamide (500mg/qm), Methotrexate (40 mg/qm), 5 FU (600mg/qm)
16224504|NCT01204437|Drug|Capecitabine, Nab-Paclitaxel|6 cycles of weekly nab-paclitaxel 100 mg/m2 on days 1, 8, 15 q22 with a week of rest every 6 weeks in combination with capecitabine 2000 mg/m2, days 1 - 14 orally, divided into 2 daily doses every 3 weeks for 6 cycles
16224505|NCT01204424|Device|minimal-invasive sinus floor augmentation with the DKK and SVP (JEDER Syst.)|minimal-invasive sinus floor augmentation with the DKK and SVP (JEDER Syst.)
16224506|NCT01204424|Device|minimal invasive crestal sinus lift with the JEDER Systh.|"The mucous membrane is opened from the toothless part of the maxillary crest up to the bone and the bone is scraped by a cylindrical cutter in the shape of a tunnel up to slightly underneath the maxillary sinus membrane and hydraulic pressure is being built up within the DKK. A centrally placed drill within the DKK slowly moves in the direction of the membrane. At the moment of the first minimal perforation of the remaining bone the pressurized fluid pushes the membrane back and ensures that the membrane is not perforated by the drill.
~The SVP is used to generate hydraulic vibrations, which help to further raise the membrane from the bone (principle of the percussion drill). After the maxillary sinus membrane has successfully been elevated, the working fluid is extracted and bone replacement material is introduced via the bore."
16224542|NCT01204203|Drug|Zometa|Zoledronic acid will be administered IV on the first day of a 21 day cycle at a concentration of 4 mg. The treatment will take about 30-60 minutes with the infusion lasting about 15 minutes.
16224724|NCT01202669|Other|No intervention planned, observational study only.|No intervention planned, observational study only.
16224507|NCT01204411|Drug|Artesunate-amodiaquine fixed-dose combination|"artesunate 25 mg / amodiaquine 67.5 mg: 1 tablet / day for 3 days for children with a weight of 5 kg to less than 9 kg;
~artesunate 50 mg / amodiaquine 135 mg: 1 tablet / day for 3 days for children with a weight of 9 kg to less than 18 kg;
~artesunate 100 mg / amodiaquine 270 mg: 1 tablet / day for 3 days for children with a weight of 18 kg to less than 36 kg;"
16224508|NCT01204398|Drug|telmisartan+amlodipine fixed dose combination|after 2 weeks placebo wash-out, patients will be administered Telmisartan 80mg/Amlodipine 5mg for 8 weeks.
16224509|NCT01204385|Procedure|Sample collection|Middle ear fluid and urine
16224510|NCT01204372|Drug|Gemcitabine - Trastuzumab - Erlotinib|"Treatment will be administered until disease progression, patient's refusal, unacceptable toxicity or investigator's decision.
~Gemcitabine: IV 1000 mg/m2 on D1, D8, D15, D22, D29, D36 and D43 followed by one week of rest. Subsequently on D1, D8 and D15 followed by one week of rest.
~Trastuzumab: IV once a week; 4 mg/kg over 90 min. at D1, and 2 mg/kg over 30 min. for the subsequent infusions.
~Erlotinib: oral route 100 mg/day from C1D1."
16224511|NCT01204359|Radiation|Iodine 131|iodine 131，185、370、555mBq，6 months
16224512|NCT01204346|Other|MBT|The intervention consists of twice weekly individual MBT therapy, group therapy with an MBT focus and weekly MBFT, which is MBT for families. The treatment duration will be 6-8 weeks.
16224513|NCT01204346|Other|treatment as usual|less intensive and structured psychotherapeutic program
16224514|NCT01204333|Drug|Endovascular thrombolysis|Endovascular thrombolysis consists of local application of alteplase or urokinase within the thrombosed sinuses. Standard endovascular techniques to mechanically remove clot material, such as thrombosuction, are allowed, but not mandatory.
16224515|NCT01204333|Drug|Heparin|The patients randomized to standard care will receive (or continue) either intravenous adjusted dose unfractionated heparin (aPTT value kept within 1.5 to 2.5 times the normal value), or any type of body-weight adjusted low molecular weight heparin in therapeutic dose, according to local custom and international guidelines
16224516|NCT01204320|Procedure|Paclitaxel-coated Balloon|POBA
16224517|NCT01204320|Device|Paclitaxel-eluting Stent|Stenting
16224518|NCT01204307|Drug|Docetaxel/cisplatin|The treatment schedule comprises a maximum of six 3-week treatment cycles consisting of weekly docetaxel (30 mg/m2) and cisplatin (37.5 mg/m2) for 2 consecutive weeks followed by a 1-week treatment-free period. The patients will be assessed after each cycle and a final assessment will be done after three and six cycles.
16224519|NCT01204307|Drug|Pemetrexed/cisplatin|The patients are given pemetrexed (500 mg/m2 as a 10-min intravenous infusion) and cisplatin (75 mg/m2) on day 1 every 21 days. Dexamethasone (4 mg) is administered twice daily on the day before, the day of, and the day after each dose of pemetrexed. Oral folic acid supplementation (1000 mg) is administered daily, beginning approximately 2 weeks prior to the first dose of pemetrexed and continues until 3 weeks after treatment discontinuation. A 1000 mg vitamin B12 injection is administered intramuscularly approximately 1-2 weeks before the first dose of pemetrexed and is repeated approximately every 9 weeks until 3 weeks after therapy discontinuation.
16224520|NCT01204294|Drug|Linagliptin|Linagliptin once daily
16224521|NCT01204294|Drug|Linagliptin|Linagliptin once daily
16224522|NCT01204294|Drug|Metformin|Metformin twice or three time per day
16224523|NCT01204294|Drug|Metformin|Metformin twice or three time per day
16224524|NCT01204294|Drug|Linagliptin|Linagliptin once daily
16224525|NCT01204294|Drug|Linagliptin|Linagliptin once daily
16224526|NCT01204294|Drug|Linagliptin|Linagliptin once daily
16224527|NCT01204281|Other|Mechanical ventilation mode (PAV+ vs. ACV)|Compare two ventilatory modes in the acute phase of illness
16224528|NCT01204268|Procedure|Sev-I group|Sevoflurane will be given before the cerebral artery clip as a preconditioning procedure for the coming ischemia-reperfusion injury.
16224529|NCT01204268|Procedure|Sevo continuous inhalation|Patients will receive the anesthesia with continuous inhalation of sevoflurane.
16224530|NCT01204255|Drug|lorazepam|Given topically
16224531|NCT01204255|Drug|diphenhydramine hydrochloride|Given topically
16224532|NCT01204255|Drug|haloperidol|Given topically
16224533|NCT01204255|Other|questionnaire administration|Ancillary studies
16224534|NCT01204255|Other|laboratory biomarker analysis|Correlative studies
16224535|NCT01204242|Drug|Placebo|"ALL subjects will receive lidocaine up to 1.5mg/kg IV (in the vein) as a rapid injection.
~Then the continuous IV infusion of the study medication (containing lidocaine 8 mg/ml or placebo) will be started and will continue for up to two hours in the recovery room."
16224536|NCT01204242|Drug|Lidocaine|"ALL subjects will receive lidocaine up to 1.5mg/kg IV (in the vein) as a rapid injection.
~Then the continuous IV infusion of the study medication (containing lidocaine 8 mg/ml or placebo) will be started and will continue for up to two hours in the recovery room."
16224537|NCT01204229|Behavioral|Motivational and Cognitive Intervention for Drinkers (MCID)|Integrate social anxiety/ depression and drinking intervention
16224538|NCT01204229|Behavioral|Brief Motivational Intervention (BMI)|Integrate drinking intervention
16224539|NCT01204216|Biological|re-infusion of biotin labeled cells|"Subjects will participate in experiments involving re-infusion of biotin-labeled cells in which a small volume (< 10 ml) of autologous, biotinylated erythrocytes will be re-infused to determine cell lifespan and in vivo HbA1c formation rate.
~These experiments require a series of small, precisely timed post-infusion blood samples over a period of 4 months, with each subject undergoing the procedure twice separated by an interval of at least 8 month"
16224540|NCT01204216|Biological|Re-infusion of biotin labeled cells|"Subjects will participate in experiments involving re-infusion of biotin-labeled cells in which a small volume (< 10 ml) of autologous, biotinylated erythrocytes will be re-infused to determine cell lifespan and in vivo HbA1c formation rate.
~These experiments require a series of small, precisely timed post-infusion blood samples over a period of 4 months, with each subject undergoing the procedure twice separated by an interval of at least 8 months.
~small volume (< 10 ml) of autologous, biotinylated erythrocytes will be re-infused to determine cell lifespan and in vivo HbA1c formation rate."
16224541|NCT01204216|Behavioral|Diabetes education/diabetes medication adjustment|Between the initial 3-4 month trial period and the second infusion of biotin labeled cells approximately 8 months later,subjects will receive diabetes education from a CDE. In addition,if needed, diabetes medications may be adjusted by the study endocrinologist to improve subject's glycemic control.
16224543|NCT01204190|Drug|Gestodene/EE Patch (BAY86-5016)|0.55 mg ethinyl estradiol (EE) + 2.1 mg gestodene (GSD) per patch; 3 treatment cycles; 21 days per treatment cycle, i.e. 3 x 7 days patch-wearing phase and a patch-free interval of 7 days
16224544|NCT01204190|Drug|Gestodene/EE Patch (BAY86-5016)|0.35 mg ethinyl estradiol (EE) + 0.67 mg gestodene (GSD) per patch; 3 treatment cycles; 21 days per treatment cycle, i.e. 3 x 7 days patch-wearing phase and a patch-free interval of 7 days
16224545|NCT01204190|Drug|Gestodene/EE Patch (BAY86-5016)|0.275 mg ethiny estradiol (EE) + 1.05 mg gestodene (GSD) per patch; 3 treatment cycles; 21 days per treatment cycle, i.e. 3 x 7 days patch-wearing phase and a patch-free interval of 7 days
16224546|NCT01204177|Drug|BAY86-9766 MEK Inhibitor + Sorafenib|All patients who meet the entry criteria will receive BAY86-9766 50mg (2x20mg + 1x10mg capsules) twice daily in combination with sorafenib 800 mg (2x200 mg tablets bid). During the first 3 weeks they will receive a reduced dose of sorafenib: 600 mg / daily (1x200mg tablet in the morning + 2x200mg tablets in the evening) daily. This dose will be increased to the standard dose of 800 mg (400 mg bid) if no major side effects occur. Treatment until PD or until one of the withdrawal criteria for this study is met as described in the protocol (e.g. radiological progression or clinical progression)
16224547|NCT01204164|Drug|TG02 citrate|TG02 citrate capsules given orally.
16224548|NCT01204164|Drug|Carfilzomib|Carfilzomib per PI
16224549|NCT01204164|Drug|Dexamethasone|Dexamethasone (Oral or IV)
16224550|NCT01204151|Behavioral|discrete-trial training|
16224551|NCT01204138|Drug|Apremilast|Apremilast 30mg BID
16224552|NCT01204138|Drug|Placebo|Placebo BID
16224553|NCT01204125|Drug|paclitaxel|"Pharmaceutical form:solution for infusion
~Route of administration: intravenous"
16224554|NCT01204125|Drug|Iniparib (SAR2405550 -BSI-201)|"Pharmaceutical form : solution for infusion
~Route of administration :Intravenous"
16224555|NCT01204112|Drug|Tasocitinib (CP-690,550) plus Rifampin|Period 1, Day 1: Tasocitinib (CP-690,550) 30 mg (single oral dose) as six 5 mg tablets Period 2, Day 1-7: Rifampin 600 mg (single oral dose) q24h Period 2, Day 8: Tasocitinib (CP-690,550) 30 mg (single oral dose) as six 5 mg tablets Period 2, Day 9: No treatment (discharge)
16224556|NCT01204099|Drug|Docetaxel|
16224557|NCT01204099|Drug|PX-866|
16224558|NCT01204086|Drug|Venlafaxine|The initial dose of venlafaxine was 37.5 mg once daily for 4 days titrated to 75 mg once daily, which could be increased by 75 mg in divided doses to a maximal daily dose of 225 mg.
16224559|NCT01204086|Drug|Fluoxetine|The initial dose of fluoxetine was 20 mg once daily, which could be increased by 20 mg in divided doses to a maximal daily dose of 80 mg.
16224560|NCT01204073|Drug|TAK-441|"TAK-441 will be administered as an oral tablet as follows:
~Patients enrolled in the dose escalation cohorts will receive:
~A single-dose administration on Day 1, followed by a 1-week washout period during which pharmacokinetics is assessed
~Continuous daily dosing on Days 8 through 28 in Cycle 1
~In subsequent cycles, continuous daily dosing over 21 days, repeated continuously
~Patients enrolled in the expansion cohorts will receive continuous daily dosing on Days 1 through 21 of each 21-day cycle"
16224561|NCT01204060|Other|Nasal allergen challenge|Subjects will receive a nasal spray containing an allergen to which they are allergic
16224562|NCT01204060|Other|Nasal placebo challenge|Subjects will receive a nasal spray with allergen diluent
16224563|NCT01204034|Drug|Inuvair|6 µg formoterol and 100 µg beclometasone dipropionate combination spray pMDI aerosol
16224564|NCT01204021|Behavioral|Tai Chi Chih|12 weeks of weekly classes of Tai Chi Chih
16224565|NCT01204021|Behavioral|Stress Education Control|Weekly meetings, for 2 hours for 12 weeks discussing issues related to stress education.
16224566|NCT01204008|Procedure|conservative discectomy|a smaller incision with removal of the disc fragment with little invasion of the disc
16224567|NCT01204008|Procedure|aggressive discectomy|a large open incision with aggressive removal of the disc fragments and curettage of the disc space
16224568|NCT01203995|Behavioral|Nutrition information|Brief nutrition education with take home reference materials and portion size tools
16224569|NCT01203995|Behavioral|Nutrition education and exercise training|Twice per week nutrition education and exercise class held either in-clinic or through vide-conference.
16224570|NCT01203982|Drug|Rosuvastatin|Rosuvastatin 5mg/day for one year
16224571|NCT01203982|Drug|Rosuvastatin|Rosuvastatin 40mg/day for one year
16224572|NCT01203969|Procedure|Single port laparoscopic surgery|laparoscopic surgery in which all the instrument was entered into the abdominal cavity through the single port in the umbilicus
16224573|NCT01203969|Procedure|Conventional laparoscopic surgery|laparoscopic surgery in which each of the instrument were entered into the abdominal cavity through the multiple port in multiple quadrants of abdomen
16224574|NCT01203956|Device|SmartFlex|Device used with smartflex engaged.
16224575|NCT01203956|Device|Standard|
16224576|NCT01203943|Drug|CC-930|CC-930 50 mg PO daily up to 56 weeks beginning on Day 1
16224577|NCT01203943|Other|Placebo|Placebo
16224578|NCT01203943|Drug|CC-930|CC-930 100 mg PO daily up to 56 weeks beginning on Day 1
16224579|NCT01203943|Drug|CC-930|C-930 100 mg twice daily approximately 12 hours apart up to 56 weeks beginning on Day 1
16224580|NCT01203930|Drug|Idelalisib|Idelalisib 150 mg tablets administered orally twice daily
16224581|NCT01203930|Drug|Rituximab|Rituximab 375 mg/m^2 administered intravenously once weekly x 8 weeks
16224582|NCT01203917|Drug|Gefitinib|250mg tablet oral, once daily until objective disease progression is documented or until other discontinuation criterion is met
16224583|NCT01203878|Drug|Photodynamic therapy|Administered 4 weeks after completion of imiquimod therapy
16224584|NCT01203878|Drug|Imiquimod|Imiquimod 3.75% cream, up to 2 packets, applied topically daily for two 2-week cycles separated by a no-treatment interval of 2-weeks, followed observation
16224585|NCT01203852|Drug|Metoprolol|"Metoprolol 50 mg twice daily titrated to 100 mg twice daily
~Note: due to discontinuation of the manufacture of chlorthalidone 15 mg, effective Jan 1, 2013; the starting dose of chlorthalidone will be 25 mg 4 times per week (Mon, Wed, Thur, Sat) with subsequent titration to 25 mg daily."
16224586|NCT01203852|Drug|Chlorthalidone|Chlorthalidone 25 mg 4 times per week titrated to 25 mg daily
16224641|NCT01203345|Drug|Placebo|An equal volume of 5 percent albumin solution
16224642|NCT01203332|Behavioral|Effectiveness of different strategies in HIV testing and linkage to care|HIV testing Linkage to Care
16224587|NCT01203839|Radiation|multiple beams utilizing either intensity-modulated or 3D-conformal techniques|A dose of 40 Gy will be delivered to the tumor bed plus 1.5-2 cm margin. Treatment will be delivered once daily, 5 days a week, for approximately 2 weeks. Radiation therapy will begin within a minimum of 4 weeks and a maximum of 3 months from definitive surgical procedure and 2-6 weeks after chemotherapy, if chemotherapy given first. Prior to radiation, patients will receive a lumpectomy with an assessment of axillary lymph node status (for invasive tumors only). Axillary assessment may be any combination of sentinel lymph node biopsy or axillary lymph node dissection.
16224588|NCT01203826|Biological|Asfotase Alfa|
16224589|NCT01203813|Other|Electronic Decision Support|"Physicians randomized to the intervention will receive:
~Electronic alerts during office visits for patients with chronic kidney disease
~Opportunity to enroll their patients with chronic kidney disease in a self management support outreach program"
16224590|NCT01203787|Drug|Sorafenib Standard Dosing Regimen|Sorafenib 400 mg twice daily until wk 24 or end of treatment
16224591|NCT01203787|Drug|Sorafenib Ramp-Up Regimen|200 mg daily, Day 0-Day 13 200 mg twice daily, Day 14-Day 20 600 mg daily, Day 21-Day 27 400 mg twice daily, Day 28 until end of treatment400 mg twice daily
16224592|NCT01203774|Drug|Glargine insulin|20-180 units per day
16224593|NCT01203748|Procedure|PVI + Lines ablation|Pulmonary vein antrum isolation with additional linear ablation (mitral line and roof line)
16224594|NCT01203748|Procedure|PVI|Pulmonary vein antrum isolation
16224595|NCT01203748|Procedure|PVI + CFE ablation|Pulmonary vein antrum isolation with additional complex fractionated electrogram ablation
16224596|NCT01203735|Drug|Valproic acid|800mg per day for entire period of RT
16224597|NCT01203722|Drug|Fludarabine|Fludarabine 30 mg/m2/day
16224598|NCT01203722|Drug|Cytoxan|Pre-BMT: Cytoxan 14.5 mg/kg/day administered IV; Post-Transplantation: High-dose Cytoxan 50mg/kg/day
16224599|NCT01203722|Radiation|Total Body Irradiation|400 cGy TBI administered in a single fraction
16224600|NCT01203722|Procedure|Allogeneic Blood or Marrow Transplant|
16224601|NCT01203722|Procedure|Peripheral Blood Stem Cell Transplant|
16224602|NCT01203722|Drug|Mycophenolate Mofetil|15mg/kg by mouth three times daily
16224603|NCT01203722|Drug|Sirolimus|Loading Dose: Sirolimus 6mg by mouth once; Maintenance dose: Sirolimus 2mg by mouth daily
16224604|NCT01203722|Drug|Tacrolimus|Tacrolimus 1mg intravenously, daily
16224605|NCT01203709|Drug|low dose combination of MMF and Tac|mycophenolate mofetil 500mg BID + tacrolimus 2mg BID
16224606|NCT01203696|Drug|Amlodipine|For patient with suboptimal angina control: oral 2.5-10mg daily
16224607|NCT01203696|Drug|Amlodipine|For patient with suboptimal BP control: 2.5-10mg daily po
16224608|NCT01203683|Behavioral|Active computer-based training|8 sessions across 4 weeks.
16224609|NCT01203683|Behavioral|Inert computer training|8 sessions across 4 weeks.
16224610|NCT01203670|Dietary Supplement|Phytalgic|Volunteers have to take three soft capsules per day, one in the morning and two in the evening.
16224611|NCT01203657|Behavioral|Tai Chi|Tai Chi classes, 60 minutes, 2x week
16224612|NCT01203644|Drug|SKY0402|Single dose of SKY0402 administered locally into the surgical wound.
16224613|NCT01203644|Drug|Bupivacaine HCl|Single dose of bupivacaine HCl (100 mg) administered locally into the surgical wound.
16224614|NCT01203631|Drug|NNC 0142-0000-0002|A single dose administered subcutaneously (s.c., under the skin)
16224615|NCT01203631|Drug|Placebo|A single dose administered subcutaneously (s.c., under the skin)
16224616|NCT01203618|Drug|Farletuzumab|Farletuzumab initial loading dose 5.0 mg/kg intravenous followed by 2.5 mg/kg intravenous for all subsequent doses every 2 weeks for up to 12 months.
16224617|NCT01203592|Drug|Albuterol|4 mg twice daily by mouth for adults. The dose for children 6 to 12 years is 2 mg two or three times daily; the dose for children 2 to 6 years is 0.1 mg/kg/day (maximum 2 mg) three times daily.
16224618|NCT01203566|Procedure|LESS appendectomy|See under arms description
16224619|NCT01203566|Procedure|Conventional 3-port laparoscopic appendectomy|See under arms description
16224620|NCT01203553|Procedure|Abdominal surgery|Intraoperative mesh implantation
16224621|NCT01203540|Drug|NAABAK eyedrops|
16224622|NCT01203540|Drug|Saline eyedrops|
16224623|NCT01203514|Drug|Erythropoietin|Infants received 400 U/kg Erythropoietin (Epo) 3 times weekly and a weekly intravenous infusion of 5 mg/kg iron dextran until they had an enteral intake of 60 mL/kg/d.
16224624|NCT01203514|Other|Sham Comparator|Infants in the placebo/control group received sham subcutaneous injections when intravenous access was not available.
16224625|NCT01203488|Drug|Vitamin A|5,000 IU (0.1 ml) was given on Mondays, Wednesdays, and Fridays for four weeks.
16224626|NCT01203488|Other|Sham Procedure|Control infants received a sham procedure rather than placebo injections.
16224627|NCT01203462|Other|Probiotic strain of Bifidobacterium|4 ounces (113g) of yogurt per day, for 14 days. Minimum Bifidobacterium dose of 1E+10 cfu/serving.
16224628|NCT01203462|Other|No Bifidobacterium|4 ounces (113g) of yogurt per day, for 14 days. No bifidobacterium added.
16224629|NCT01203436|Procedure|Supplemental Oxygen Management|Supplemental arm with pulse oximetry targeted at 96% to 99% saturation, for at least 2 weeks, and until both eyes were at study endpoints.
16224630|NCT01203436|Procedure|Conventional Oxygen Management|Conventional oxygen arm with pulse oximetry targeted at 89% to 94% saturation.
16224631|NCT01203397|Drug|TOPIC MUCOPOLYSACCHARIDE POLYSULFATE 5MG/G|APLIED 4 TIMES/DAY AT LESION
16224632|NCT01203384|Drug|CHF5074 1x|oral tablet, 1x, once a day in the morning for 14 days
16224633|NCT01203384|Drug|CHF5074 2x|oral tablet, 2x, once a day in the morning for 14 days
16224634|NCT01203384|Drug|CHF5074 3x|oral tablet, 3x, once a day in the morning for 14 days
16224635|NCT01203384|Drug|Placebo|oral tablet, placebo, once a day in the morning for 14 days
16224636|NCT01203371|Drug|Naftopidil|0,25 mg (2weeks) and 0,50 mg (10 weeks)
16224637|NCT01203371|Drug|Tamsulosin|0,4 mg/day
16224638|NCT01203358|Drug|Exosurf|Infants received up to four intratracheal doses of the surfactant.
16224639|NCT01203358|Drug|Survanta|Infants received up to four intratracheal doses of the surfactant.
16224640|NCT01203345|Drug|IVIG|The infants received their first dose of study drug within 24 hours of randomization.
16225778|NCT01194375|Drug|Low Strength IDP-107|Once a day for 16 weeks
16224643|NCT01203319|Biological|60mcg/1.0ml recombinant hepatitis B vaccine|to receive 60mcg/1.0ml recombinant HBV vaccines on day 0, 30 and 60
16224644|NCT01203319|Biological|30mcg/1.0ml recombinant hepatitis B vaccine|to receive 30mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60.
16224645|NCT01203319|Biological|10mcg/1.0ml recombinant hepatitis B vaccine|to receive 10mcg/1.0ml recombinant hepatitis B vaccines on day 0, 30 and 60
16224646|NCT01203306|Drug|bevacizumab + octreotide LAR + capecitabine|long acting octreotide acetate at a dose of 20 or 30 mg administered intramuscularly every 4 weeks; Bevacizumab at a dose of 5 mg/kg every 2 weeks; orally capecitabine administered at a dose of 2000 mg/daily
16224647|NCT01203293|Behavioral|Cognitive behavior based therapy|15-20 individual psychotherapy sessions
16224648|NCT01203293|Behavioral|Treatment as usual|Treatment as usual is an active comparator group in which patients are provided referrals to specialty mental health care services or can use any primary or specialty care services available to them in usual care.
16224649|NCT01203280|Other|icing massage|The intervention, ice massage, was conducted by replacing a bag of crushed ice (100 cc) inside a moistened towel and lightly rubbed over lumbosacral region for 10 minutes. The moisture towel increased the intensity of the cooling sensation more than the dry wrappings
16224650|NCT01203267|Drug|Paclitaxel, Carboplatin|Paclitaxel 80 mg/m2, carboplatin AUC of 2 mg/min/ml, given on days 1, 8 and 15 of a 28-day cycle.
16224651|NCT01203254|Drug|Colesevelam|Colesevelam 625 mg tablet; 3 times daily 2 tablets
16224652|NCT01203254|Drug|Placebo|Placebo tablet: 3 times daily 2 tablets
16224653|NCT01203241|Procedure|Pulmonary vein encircling|Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum
16224654|NCT01203241|Procedure|Pulmonary vein encircling plus roof ablation|Pulmonary vein encircling by performing continuous radiofrequency lesions surrounding each ipsilateral pulmonary vein antrum plus creation of a radiofrequency line joining contralateral superior pulmonary veins throughout the left atrial roof.
16224655|NCT01203228|Other|Reduced Intensity Conditioning|"Busilvex®:
~6.4 mg/kg IBW i. v. day -7: 0.8 mg/kg IBW x 4 (2 hour infusion every 6 hours) day -6: 0.8 mg/kg IBW x 4 (2 hour infusion every 6 hours)
~or (if i.v.-application is not available)
~Busulfan:
~8.0 mg/kg BW p. o.: day -7: 4.0 mg/kg BW day -6: 4.0 mg/kg BW
~plus:
~Fludarabine:
~5 x 30 mg/m² BS i. v.: day -7: 30 mg/m² BS day -6: 30 mg/m² BS day -5: 30 mg/m² BS day -4: 30 mg/m² BS day -3: 30 mg/m² BS"
16224656|NCT01203228|Other|Myeloablative conditioning|"Busilvex®:
~12.8 mg/kg IBW i. v.; day -9: 0.8 mg/kg IBW x 4 (2 hour infusion every 6 hours) day -8: 0.8 mg/kg IBW x 4 (2 hour infusion every 6 hours) day -7: 0.8 mg/kg IBW x 4 (2 hour infusion every 6 hours) day -6: 0.8 mg/kg IBW x 4 (2 hour infusion every 6 hours)
~or (if i.v.-application is not available):
~Busulfan:
~16.0 mg/kg BW p. o.; day -9: 4.0 mg/kg BW day -8: 4.0 mg/kg BW day -7: 4.0 mg/kg BW day -6: 4.0 mg/kg BW
~plus:
~Cyclophosphamide:
~120 mg/kg BW i. v.; day -4: 60 mg/kg BW day -3: 60 mg/kg BW"
16224657|NCT01203215|Behavioral|2 print based physical activity interventions|physical activity promotion
16224658|NCT01203202|Drug|Clomipramine|15mg and 30mg on demand
16224659|NCT01203189|Drug|ketoconazole 2% foam|Subjects in the Foam (F) group will apply ketoconazole 2% foam to the scalp twice daily for four weeks.
16224660|NCT01203189|Drug|ketoconazole 2% shampoo|Subjects in the Shampoo (S) group will wash their hair twice weekly for four weeks with ketoconazole 2% shampoo.
16224661|NCT01203176|Procedure|Hysteroscopic polypectomy|Hysteroscopy is a well established minimally invasive surgery method for diagnostic and intervention operations inside the uterine cavity. Using this method one can observe the endometrium and remove polyps.
16224662|NCT01203150|Other|Exercise|CRT will occur 3 times per week for 26 weeks. Each training session will last approximately 40-45 minutes and employ resistance training (weight lifting) and high-speed, low intensity endurance activities (arm cranking) with interposed periods of incomplete recovery (i.e., heart rate not falling to baseline).
16224663|NCT01203124|Drug|AZD8848|The subjects are dosed with a range of intranasal doses of AZD8848 on 2, 3, 4 or 7 days of the 7 days treatment period. On the other days the subjects receive placebo.
16224664|NCT01203124|Drug|Placebo|Placebo
16224665|NCT01203111|Drug|INSULIN GLARGINE|Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: once a day in the evening at bedtime
16224666|NCT01203111|Drug|INSULIN GLULISINE|Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: once a day, 0 to 15 minutes before the main meal
16224667|NCT01203098|Drug|DU-176b 15mg|DU-176b 15 mg tablets oral, once daily for 2 weeks initiated within 6 to 24 hours after surgery.
16224668|NCT01203098|Drug|DU-176b 30mg|DU-176b 30 mg tablets, oral once daily for 2 weeks initiated within 6 to 24 hours after surgery.
16224669|NCT01203098|Drug|Enoxaparin sodium 20 mg (=2000IU)|Enoxaparin sodium 20 mg (=2000IU) / 0.2ml twice daily, subcutaneous injection for 2 weeks initiated within 24 to 36 hours after surgery.
16224670|NCT01203072|Drug|DU-176b|DU-176b 5mg tablets oral, once daily for 2 weeks
16224671|NCT01203072|Drug|DU-176b|DU-176b 15mg tablets, oral once daily for 2 weeks
16224672|NCT01203072|Drug|DU-176b|DU-176b 30 mg tablets, oral, once daily for 2 weeks
16224673|NCT01203072|Drug|DU-176b|DU-176b 60 mg tablets, oral, once daily for 2 weeks
16224674|NCT01203072|Drug|Placebo|Matching placebo oral tablets, once daily for 2 weeks
16224675|NCT01203046|Drug|Ertapenem|Ertapenem 1 gr endovenous 3 or 7 days
16224676|NCT01203020|Drug|Busulfan|Busulfex 130 mg/m2 intravenous piggy back (IVPB) for 4 days (Day -6 to -3) pharmacokinetic (PK) samples for Busulfex dose adjustment drawn on Day -6
16224677|NCT01203020|Drug|Fludarabine|Fludarabine 40 mg/m2 IVPB for 4 days (Day -6 to -3)
16224678|NCT01203007|Dietary Supplement|Tailored diet|Tailored diet according to demonstrated food sensitivity, 6 months
16224679|NCT01203007|Dietary Supplement|Low antigen content diet|Low-antigen content diet for one month
16224719|NCT01202721|Drug|Telmisartan|Telmisartan or matching placebo 40 mg up-titrated to 80mg.
16224720|NCT01202708|Device|On line hemofiafiltration|hemodiafiltration with the Gambro AK 200 ULTRA
16224721|NCT01202708|Device|On line hemodiafiltration|On line hemodiafiltration with the Gambro AK 200 ULTRA System
16224722|NCT01202695|Drug|AVP-21D9|intravenously, single dose
16224723|NCT01202695|Drug|Placebo|Placebo comparator
16225779|NCT01194375|Drug|High Strength IDP-107|Once a day for 16 weeks
16224680|NCT01202994|Drug|18F-Flutemetamol|"All subjects will undergo a PET scan with 18F-PIB, within six months of also undergoing an FDG-PET scan (PET scans will occur on separate days).
~For the 18F-PIB PET scan: Approximately 185 MBq (5 mCi) of 18F-PIB will be injected intravenously and PET data collected for each subject.
~The FDG-PET scan will follow the same procedures as routine scans obtained in a clinical setting (approximately 370 MBq of 18F-FDG will be injected intravenously and PET data collected for each subject). FDG-PET data will be used to correlate metabolic changes and for anatomic co-registration of 18F-PIB images."
16224681|NCT01202968|Procedure|Transcutaneous neuro-muscular electrical stimulation|Neuro-muscular electrical stimulation with two pairs of surface electrodes was applied to submental area. One paired electrodes to be placed horizontally was attached on the anterior half of area between mandible and hyoid bone. The other was affixed to posterior half of the same area far laterally. Bipolar electrical stimulation with pulse rate of 80-Hz, duration of 700 µs and intensity to evoke visible muscle contraction was performed for 60 minutes a day until one day before extubation.
16224682|NCT01202955|Drug|Tolcapone|Day 1 100mg three times per day Day 2 - Day 7 200mg three times per day Day 8 200mg twice a day Day 9 200mg once a day Day 10 100mg once a day
16224683|NCT01202955|Drug|Placebo|Day 1 100mg three times per day Day 2 - Day 7 200mg three times per day Day 8 200mg twice a day Day 9 200mg once a day Day 10 100mg once a day
16224684|NCT01202942|Other|Quest|Participants smoke Quest cigarettes level 1 for 10 days, level 2 for 10 days, level 3 for 10 days.
16224685|NCT01202929|Procedure|High Resolution Manometry|High Resolution Manometry which uses 36 solid state sensors spaced at 1-cm intervals, positioned from the hypopharynx to the stomach.
16224686|NCT01202903|Drug|Omalizumab|The minimum dose of 0.016 mg/kg/IgE (IU/mL) omalizumab was administered every 4 weeks by subcutaneous injection.
16224687|NCT01202903|Drug|Placebo|The minimum dose of 0.016 mg/kg/IgE (IU/mL) placebo was administered every 4 weeks by subcutaneous injection.
16224688|NCT01202890|Drug|Lenalidomide, Liposomal Doxorubicin, Bevacizumab|"At the expansion phase: Revlimid 20 mg (days 1-21), Doxil 30 mg/m2 on Day 1 and Avastin 15 mg/kg on Day 1, every 3 weeks. If this regimen is not cumulatively tolerable, Avastin will be administered every other course.
~Patients will be received up to 6 cycles or disease progression, followed by Revlimid maintenance at 25 mg PO q Day for 3 weeks every 4 weeks in patients with stable disease."
16224689|NCT01202890|Drug|Revlimid, Doxil, Avastin|At the expansion phase: Revlimid 20 mg (days 1-21), Doxil 30 mg/m2 on Day 1 and Avastin 15 mg/kg on Day 1, every 3 weeks. If this regimen is not cumulatively tolerable, Avastin will be administered every other course. Patients will be received up to 6 cycles or disease progression, followed by Revlimid maintenance at 25 mg PO q Day for 3 weeks every 4 weeks in patients with stable disease.
16224690|NCT01202877|Drug|5-azacytidine|Starting dose: 75 mg/m2/d subcutaneously (SQ) or by vein (IV) on days 1-7 of a 28 day cycle.
16224691|NCT01202877|Drug|PKC412|Starting dose: 50 mg by mouth twice daily for 14 days (days 8-21), of every 28 day cycle. Starting with cycle 2, PKC412 administered continuously (daily).
16224692|NCT01202851|Other|Relaxation Program|3 times a week, 60 minute sessions for 6 weeks.
16224693|NCT01202851|Behavioral|Questionnaires|Multiple questionnaires taken before, during and after radiotherapy/exercise intervention programs during course of study.
16224694|NCT01202851|Other|Saliva Testing|4 saliva samples per day for cortisol testing for 3 days before radiation therapy begins, for 3 days in the last week of radiation therapy, for 3 days in a row 3 months after radiation therapy ended, for 3 days in a row, for 6 months after radiation therapy ended, and for 12 months after radiation therapy ended.
16224695|NCT01202838|Device|Composite Implant|Subjects receiving composite implants
16224696|NCT01202825|Drug|TMC647055|One single dose as oral solution, doses from 100 mg up to a maximum of 3000 mg increasing in sessions I through VI.
16224697|NCT01202825|Drug|Placebo|Oral solution given in session XI every 12 hours, in session XII every 12 or 8 hours. Doses and regimen will be determined based on outcome of previous sessions.
16224698|NCT01202825|Drug|TMC647055|Oral solution given in session XIII, treatment arm 1 during 10 days at a dose of 1000 mg every 12 hours.
16224699|NCT01202825|Drug|TMC647055|In sessions VIII through X, oral solution given once daily, every 12 hours or every 8 hours on 6 consecutive days. Doses are based on outcome of previous sessions.
16224700|NCT01202825|Drug|Placebo|One single dose as oral solution, selected dose ranging between 100 and 3000 mg in session VII
16224701|NCT01202825|Drug|TMC435|Oral capsule given in session XIII, in treatment arm 1 during 10 days and in treatment arm 2 during 6 days at a dose of 150 mg once daily.
16224702|NCT01202825|Drug|Placebo|One single dose as oral solution, selected dose ranging between 100 and 3000 mg in session VII
16224703|NCT01202825|Drug|TMC647055|One single dose as oral solution, selected dose ranging between 100 and 3000 mg in session VII
16224704|NCT01202825|Drug|Placebo|In sessions VIII through X, oral solution given once daily, every 12 hours or every 8 hours on 6 consecutive days. Doses are based on outcome of previous sessions.
16224705|NCT01202825|Drug|TMC647055|Oral solution given in session XI every 12 hours, in session XII every 12 or 8 hours. Doses and regimen will be determined based on outcome of previous sessions.
16224706|NCT01202812|Dietary Supplement|Omega-3 Fatty Acids: Eicosapentaenoic Acid (EPA) and Docosahexaenoic Acid (DHA)|Eicosapentaenoic Acid (EPA)/Docosahexaenoic Acid (DHA) 30mg/kg (LOVAZA capsules) given by mouth daily for 6 months.
16224707|NCT01202812|Other|Placebo Capsules|Placebo capsules given by mouth daily for 6 months.
16224708|NCT01202799|Drug|2% w/w diclofenac sodium topical gel|2% w/w diclofenac sodium topical gel
16224709|NCT01202799|Drug|1.5% w/w diclofenac sodium topical solution|1.5% w/w diclofenac sodium topical solution
16224710|NCT01202799|Drug|75 mg diclofenac sodium delayed release tablet|75 mg diclofenac sodium delayed release tablet
16224711|NCT01202773|Drug|LY2127399|Administered Subcutaneously (SC)
16224712|NCT01202773|Drug|Placebo Q4W|Administered SC
16224713|NCT01202773|Drug|Placebo Q2W|Administered SC
16224714|NCT01202760|Drug|LY2127399|
16224715|NCT01202760|Drug|Placebo|
16224716|NCT01202747|Device|LipiFlow System|In-office treatment for meibomian gland dysfunction
16224717|NCT01202734|Drug|Methylphenidate HCl|Period 1: One tablet, oral, 36 mg, once daily, single-dose on Day 1
16224718|NCT01202721|Drug|Atenolol|Atenolol or matching placebo 25 mg up-titrated to 100 mg
16224725|NCT01202656|Drug|G-CSF|One infusion of G-CSF 300 units administered by intrauterine infusion
16224726|NCT01202656|Drug|Saline|intrauterine saline infusion 1 cc
16224727|NCT01202643|Drug|G-CSF|One infusion of G-CSF 300 units administered by intrauterine infusion
16224728|NCT01202643|Drug|Saline|One intrauterine saline infusions of 1 cc
16224729|NCT01202630|Dietary Supplement|Lactobacillus acidophilus CL1285® and Lactobacillus casei|2 capsules of Lactobacillus acidophilus CL1285® and Lactobacillus casei (50 billion cfu/capsule), consumed once daily for 60 days
16224730|NCT01202630|Dietary Supplement|Placebo|2 capsules of placebo (no live cells), consumed once daily for 60 days
16224731|NCT01202591|Drug|AZD4547|Tablet oral twice daily
16224732|NCT01202591|Drug|Exemestane|Tablet oral once daily
16224733|NCT01202591|Drug|Placebo|Tablet oral twice daily
16224734|NCT01202591|Drug|Fulvestrant|A monthly intramuscular injection of a depot formulation with a loading dose 14 days after initial administration
16224735|NCT01202578|Device|tympanostomy tube|tympanostomy tube delivery system
16224736|NCT01202552|Biological|seasonal influenza vaccine|receives a single intramuscular dose of 0.5 ml of trivalent influenza vaccine, containing at least 15 microgram of hemagglutinin antigen per strain
16224737|NCT01202552|Biological|seasonal influenza vaccine|receives two-site intradermal dose of 0.1 ml each, containing at least 3 microgram of hemagglutinin antigen per strain per site and group
16224738|NCT01202552|Biological|seasonal influenza vaccine|receives two-site intradermal dose of 0.2 ml each, containing at least 6 microgram of hemagglutinin antigen per strain per site
16224739|NCT01202513|Drug|Bimatoprost 0.03% topical ophthalmic solution|
16224740|NCT01202500|Procedure|reducing treatment to 3 months|The treatment will be stopped after 3 months
16224741|NCT01202500|Procedure|registered length of treatment|The treatment procedure will follow the actual recommandation
16224742|NCT01202487|Drug|LET - Lidocaine Epinephrine Tetracaine|One time application of 3 cc of Lidocaine Epinephrine Tetracaine Solution at least 45 minutes prior to laceration repair
16224743|NCT01202474|Drug|INSULIN GLULISINE|Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: once a day
16224744|NCT01202474|Drug|INSULIN GLARGINE|Pharmaceutical form:solution for injection Route of administration: subcutaneous Dose regimen: 0-15 minutes before meal or within 20 minutes from the start of meal according to prandial plasma glucose values
16224745|NCT01202461|Procedure|Triple therapy of vitrectomy, IVTA and grid/focal laser photocoagulation|"all pars plana vitrectomy were accompanied with removal of retinal Internal limiting membrane (ILM) around fovea in round fashion with a dimension of approximately 2 disc diameters.
~IVTA was introduced at the end of surgery or on the next day (4mg in 0.1cc). Two weeks afterward, fluorescein angiography guided macular laser photocoagulation which consisted of direct photocoagulation on leaking microaneurysms and application of grid pattern laser was undertaken."
16224746|NCT01202448|Procedure|CSF analysis|The cerebrospinal fluid will be evaluated via lumbar puncture.
16224747|NCT01202435|Drug|Pregabalin controlled release, 82.5 mg|82.5 mg controlled release tablet administered once daily for four days.
16224748|NCT01202435|Drug|Pregabalin immediate release, 25 mg|25 mg immediate release capsules administered three times daily for four days
16224749|NCT01202422|Drug|Pregabalin controlled release, 165 mg|Two tablets of 165 mg controlled release (administered concurrently) once daily for four days.
16224750|NCT01202422|Drug|Pregabalin controlled release, 330 mg|330 mg controlled release tablet administered once daily for four days.
16224751|NCT01202422|Drug|Pregabalin immediate release, 150 mg|150 mg immediate release capsules administered every 12 hours for four days
16224752|NCT01202409|Drug|Panitumumab|Starting Dose Level: 9 mg/kg by vein over 60 minutes on day 1 of a 14 day cycle.
16224753|NCT01202383|Behavioral|Household-based water treatment with NADCC tablets|Study participants will be supplied with tablets and encouraged to use them for treating their water daily
16224754|NCT01202383|Behavioral|Household-based water treatment with placebo tablets|Study participants will be supplied with tablets and encouraged to use them for treating their water daily
16224755|NCT01202370|Drug|7-t-butyldimethylsilyl-10-hydroxycamptothecin|IV Over 1 hour Days 1, 4, 8, 12 & 15 of a 21 day cycle (7.5 mg/m^2).
16224756|NCT01202357|Behavioral|Community Case Management|Community case management for psychosis by designated key-worker according to specified protocol
16224757|NCT01202344|Other|Additional x-ray images|Approximately 3 additional x-ray images following angioplasty (within 1 hour)
16224758|NCT01202331|Drug|mass treatment with oral azithromycin|For baseline and follow-up surveys prior to azithromycin distribution, a stratified random sample from two age groups will be chosen: 1) 60 study participants younger than 10 years old and 2) 60 study participants aged 10 years and above. Clinical examination will be performed and conjunctival swabs will be taken from all the study participants. Nasopharyngeal swabs will be collected in each community from 15 randomly selected children among the 60 participants under age 10 who were recruited for conjunctival swabbing. Then a single dose of azithromycin will be distributed according to study design: in tablet form for adults; a weight-adjusted tablet dose for children ages 8-10; and pediatric suspension for children ages 1 - 7.
16224759|NCT01202305|Procedure|Lymph node biopsy|Inguinal lymph node biopsy
16224760|NCT01202292|Behavioral|Behavioral (e.g., Psychotherapy, Lifestyle Counseling)|Group motivational intervention consist in expert psychologist 32 monthly sessions (group intervention) on top of the diet plus exercise
16224761|NCT01202279|Drug|Guaifenesin|1200 mg guaifenesin and 120 mg pseudoephedrine HCl bid for 7 days
16224762|NCT01202279|Device|Placebo|Placebo bid for 7 days
16224763|NCT01202266|Drug|PF-05161704 or Placebo|PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner
16224764|NCT01202266|Drug|PF-05161704 or Placebo|PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner
16224765|NCT01202266|Drug|PF-05161704 or Placebo|PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner
16224766|NCT01202266|Drug|PF-05161704 or Placebo|PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner
16225780|NCT01194375|Drug|Placebo|Once a day for 16 weeks
16224767|NCT01202266|Drug|PF-05161704 or Placebo|PF-05161704 and Placebo (3:1) oral dosing Suspensions administered twice daily for 14 days immediately after breakfast and dinner or once daily for 14 days immediately after breakfast
16224768|NCT01202266|Drug|PF-05161704 or Placebo|PF-05161704 and Placebo (3:1) oral dosing Suspensions administered once daily for 14 days immediately after breakfast
16224769|NCT01202266|Drug|PF-05161704 or Placebo|PF-05161704 and Placebo (3:1) oral dosing Suspensions administered once daily for 14 days immediately after breakfast
16224770|NCT01202266|Drug|PF-05161704 or Placebo|PF-05161704 and Placebo (3:1) oral dosing Suspensions administered once daily for 14 days immediately after breakfast
16224771|NCT01202253|Drug|anidulafungin|A single 200 mg loading dose should be administered on Day 1, followed by 100 mg daily thereafter.
16224772|NCT01202240|Drug|Tasocitinib (CP-690,55) plus Ketoconazole|Period 1, Day 1: tasocitinib (CP-690,550) as a single oral 10 mg dose given as two 5 mg tablets Period 2, Days 1-2: ketoconazole as a daily single oral 400 mg (dose given as two 200 mg tablets Period 2, Day 3: ketoconazole as a single oral 400 mg dose given as two 200 mg tablets PLUS tasocitinib (CP-690,550) as a single oral 10 mg oral dose given as two 5 mg tablets Period 2, Day 4: No treatment (discharge)
16224773|NCT01202227|Drug|pregabalin|Pregabalin capsules taken twice a daily (150-600mg/day)
16224774|NCT01202214|Drug|1440115|
16224775|NCT01202214|Drug|Placebo|matching placebo
16224776|NCT01202201|Other|Database analysis|Review and collect data from database (electronic admission database or any other applicable database of the hospital)
16224777|NCT01202188|Drug|indacaterol and glycopyrronium (QVA149)|Capsules for inhalation delivered via SDDPI.
16224778|NCT01202188|Drug|glycopyrronium (NVA237)|Capsules for inhalation delivered via SDDPI.
16224779|NCT01202188|Drug|indacaterol (QAB149)|Capsules for inhalation delivered via SDDPI.
16224780|NCT01202188|Drug|tiotropium|Capsules for inhalation delivered via HandiHaler® device.
16224781|NCT01202188|Drug|placebo|Placebo to match capsules for inhalation delivered via SDDPI.
16224782|NCT01202175|Drug|Nebivolol|Oral nebivolol 2.5-5mg once daily
16224783|NCT01202162|Drug|Desflurane|Administratino of Desflurane
16224784|NCT01202162|Drug|Administration of Sevoflurane|Administration of Sevoflurane
16224785|NCT01202149|Device|Elidel (pimecrolimus cream, 1%) Hylatopic Plus Emollient Foam (non-medicated device)|
16224786|NCT01202110|Drug|Propranolol|
16224787|NCT01202097|Drug|Salmeterol/Fluticasone|
16224788|NCT01202097|Drug|Seretide|
16224789|NCT01202084|Drug|Formoterol/Fluticasone|
16224790|NCT01202084|Drug|Foraseq®|
16224791|NCT01202084|Drug|Fluticasone|
16224792|NCT01202071|Drug|Rabeprazole sodium, 5 mg Tablets|"Rabeprazole sodium Tablets, 5 mg administered for 5 days.
~Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer.
~Day 2 to Day 4: participants received a single dose with 200 mL of water >= 2 hours after the completion of breakfast."
16224793|NCT01202071|Drug|Rabeprazole sodium, 10 mg Tablets|"Rabeprazole sodium Tablets, 10 mg administered for 5 days.
~Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer.
~Day 2 to Day 4: participants received a single dose with 200 mL of water >= 2 hours after the completion of breakfast."
16224794|NCT01202071|Drug|Rabeprazole sodium, 20 mg Tablets|"Rabeprazole sodium Tablets, 20 mg administered for 5 days.
~Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer.
~Day 2 to Day 4: participants received a single dose with 200 mL of water >= 2 hours after the completion of breakfast."
16224795|NCT01202071|Drug|Rabeprazole sodium, 40 mg Tablets (two 20 mg Tablets)|"Rabeprazole sodium Tablets, 40 mg (two 20 mg Tablets) administered for 5 days.
~Day 1 and Day 5: participants received a single dose with 200 mL of water in the morning while fasting for 10 hours or longer.
~Day 2 to Day 4: participants received a single dose with 200 mL of water, >=2 hours after the completion of breakfast."
16224796|NCT01202058|Device|NEVO™ Sirolimus-eluting Coronary Stent System|"Design Original Protocol
~Intervention will consist of percutaneous coronary intervention for treatment of a single or multiple coronary lesion(s) using standard coronary intervention techniques. Intervention in this arm will include treatment with the NEVO™ Sirolimus-eluting Coronary Stent System. Subjects assigned to the IVUS sub-study population will undergo intravascular ultrasound evaluation immediately post-stenting."
16224797|NCT01202058|Device|XIENCE V®/XIENCE PRIME™/PROMUS® Everolimus-eluting Coronary Stent System)|Intervention will consist of percutaneous coronary intervention for treatment of a single or multiple coronary lesion(s) using standard coronary intervention techniques. Intervention in this arm will include treatment with the XIENCE V®/XIENCE PRIME™/PROMUS® Everolimus-eluting Coronary Stent System. Subjects assigned to the IVUS sub-study population will undergo intravascular ultrasound evaluation immediately post-stenting.
16224798|NCT01202032|Drug|Association of Bevacizumab (BVC)+ Pazopanib (PZP)|"Treatment is administered in 28-day cycles, during which patients received BVC intravenously every 2 weeks and oral PZP once daily from days 1 to 28. For the first cycle, PZP is administered alone from days 1 to 14.
~The starting dose for dose escalation is BVC at 7.5 mg/kg in combination with PZP 400 mg (level 1).
~The therapy regimens for each dose level are respectively:
~BVC 7.5 mg/kg + PZP 600 mg (level 2) BVC 10 mg/kg + PZP 600 mg (level 3) BVC 10 mg/kg + PZP 800 mg (level 4). Patients who experience grades 3 to 4 adverse events have dose adjustments to one or both drugs. Dose reductions affect in priority the administration of PZP. Doses reductions to PZP are made in 200-mg decrements and to BVC to 2.5-mg/kg decrements.
~Patients with toxicities that warrant reductions at either PZP 400 mg or BVC 7.5 mg/kg are withdrawn from the study."
16224799|NCT01202019|Other|Circuit Resistance Training (CRT)|CRT will occur 3 times per week for 26 weeks. Each session will last approximately 40-45 minutes and employ resistance training (weight lifting) and endurance activities (reciprocal arm exercise, Vita-Glide®, RehaMed International) with interposed periods of incomplete recovery (i.e., heart rate not falling to baseline).
16224800|NCT01202006|Other|Training of general practitioners in an uptitration protocol.|The general practitioners randomly allocated to the intervention group will be trained in the practical appliance of the Dutch GP's 'heart failure' guideline. They will receive detailed instructions on initiating diuretics with ACE-inhibitors and uptitration of ACE-inhibitors and beta-blockers.
16224876|NCT01201278|Drug|Insulin|Nasal insulin at a dose estimated to be equivalent to 16 IU bioavailable insulin
16224801|NCT01201967|Other|Collaborative care|Study care manager provides psychoeducation, therapy, and care coordination between patient, psychiatrist, and primary medical physicians.
16224802|NCT01201967|Other|Usual care|Patient's primary medical physician informed of mental health symptoms/diagnosis
16224803|NCT01201954|Drug|sucrose|oral sucrose solution, 24%, 0,5 ml/kg, 2 minutes before start the suctioning sterile water, 0,5 ml/kg, 2 minutes before start the suctioning
16224804|NCT01201941|Other|e-Chasqui|"The laboratory component of the PIH-EMR, termed e-Chasqui, permits web-based entry of culture and DST results at all regional and central laboratories performing these tests. In addition, the system includes applications to assess quality control, generate aggregate reports, notify health centers of new results or contaminated samples, and track enrolled patients and the status of pending laboratory tests."
16224805|NCT01201928|Drug|Comparator administered in parent trial|Comparator arm may be different for each parent trial, consisting of some sort of usual care for diabetes
16224806|NCT01201928|Drug|Technosphere Insulin Inhalation Powder|Pulmonary delivered inhaled insulin formulation containing human insulin and Technosphere Inhalation Powder (administered in parent trial)
16224807|NCT01201915|Drug|Vismodegib|Vismodegib was supplied in gelatin capsules.
16224808|NCT01201902|Biological|Adjuvanted influenza A(H1N1) vaccine|0.25ml, Intramuscular on Day 0 and 21
16224809|NCT01201902|Biological|Adjuvanted influenza A(H1N1) vaccine|0.5ml, Intramuscular on Day 0 and 21
16224810|NCT01201902|Biological|un-adjuvanted influenza A(H1N1) vaccine|0.5ml, Intramuscular on Day 0 and 21
16224811|NCT01201902|Biological|Adjuvanted influenza A(H1N1) vaccine|0.25ml, Intramuscular on Day 0 and 21
16224812|NCT01201902|Biological|Adjuvanted influenza A(H1N1) vaccine|0.5ml, Intramuscular on Day 0 and 21
16224813|NCT01201863|Drug|Androgel (Testosterone Gel)|2.5 gram stickpacks administered with starting dosage of 5g increasing to a max of 10g.
16224814|NCT01201863|Other|Placebo gel|2.5 gram stickpacks with starting dose of 5g increasing to max of 10g.
16224815|NCT01201850|Drug|Bevacizumab (Avastin®)|Once enrolled on study, patients will be treated with bevacizumab (10mg/kg) intravenously (i.v.) every 2 weeks for a total of 6 doses. An MRI will be done after the first cycle (3 doses/ 6weeks) and then again at the end of therapy.
16224816|NCT01201837|Drug|Placebo|Weekly injection
16224817|NCT01201837|Drug|CER-001|Weekly injection
16224818|NCT01201824|Procedure|intracavitary ultrasound|intracavitary ultrasound done during surgical intervention
16224819|NCT01201811|Drug|Azacitidine|Subjects will receive azacitidine 75 mg/m2/day SC for 7 days every 28 days for up to 6 cycles, unless they are discontinued from the treatment. In addition, subjects may receive best supportive care as needed, including antibiotics and transfusions, per Investigator discretion.
16224820|NCT01201798|Drug|Difluprednate 0.05% ophthalmic emulsion|1 drop in study eye, 4 times a day, for 14 days, followed by a 14-day tapering period dependent on the Investigator's determination of adequate response to treatment
16224821|NCT01201798|Drug|Prednisolone acetate 1.0% ophthalmic suspension|1 drop in study eye, 8 times a day, for 14 days, followed by a 14-day tapering period dependent on the Investigator's determination of adequate response to treatment
16224822|NCT01201785|Drug|Aspirin|After having been on aspirin 81mg/daily for at least one-week, patients switched their aspirin regimen on a weekly basis according to the following scheme: aspirin 81mg twice daily (bid) for one week; aspirin 162 mg once daily (od) for one week; aspirin 162 mg bid for one week; aspirin 325 mg od for one week. Pharmacodynamic assessments were made after each sequence (5 time-points). Afterward, patients resumed the dose of aspirin that they were on prior to entering the study.
16224823|NCT01201772|Drug|Prasugrel|Prasugrel 10mg, 30mg, or 60mg
16224824|NCT01201759|Drug|Salsalate 2grams twice a day for 30 days. Then Placebo for 30 days|Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2
16224825|NCT01201759|Drug|Placebo twice a day for 30 days. Then Salsalate 2gr BID for 30 days.|Participants will undergo randomization to either 1 month of Salsalate (4.0 g/day) or placebo. An untreated wash-in (1 month) will precede treatment (1 month), and a washout cross-over period (1 month) will follow. After the wash-in month participants will receive either Salsalate or the placebo. The last month will test effects of drug-placebo not examined in month 2.
16224826|NCT01201746|Procedure|Delayed treatment|Scaling, Root Planing and oral hygiene instruction
16224827|NCT01201746|Procedure|Periodontal therapy|Scaling, root planning and oral hygiene instructions
16224828|NCT01201733|Other|Traditional Thai massage|The participants will receive a thirty minutes session of traditional Thai massage onto the scapular region
16224829|NCT01201733|Other|Ultrasound therapy and hot pack|
16224830|NCT01201720|Procedure|Plasma exchange with albumin|Realization of 6 plasma exchange with albumin in 11 days
16224831|NCT01201707|Procedure|Angioplasty|In this procedure, a small catheter (tube) that is approximately the size of a piece of spaghetti is introduced into the vein that is narrowed based on the findings of the venogram. This catheter has a small balloon on it. That balloon is inflated across the narrowing within the vein with the goal of increasing the diameter of that vein and improving flow within that vein.
16224832|NCT01201707|Other|Observation|Patients in this arm will be diagnosed with CCSVI based on venography but will receive no intervention. They will be followed in the same manner as patients treated with angioplasty.
16224833|NCT01201694|Drug|Surface-Controlled Water Soluble Curcumin|Starting dose 100 mg by mouth two times a day of a 28 day cycle.
16224834|NCT01201694|Drug|Surface-Controlled Water Soluble Curcumin MTD|Dose will be maximum tolerated dose (MTD) from Arm 1.
16224835|NCT01201642|Drug|Prednisolone|Prednisolone as 5 mg tablets will be given as a single dose of 40 mg daily for 10 days; the dose will then be reduced by 10 mg per 5 day, with a total treatment time of 20 days.
16224877|NCT01201278|Drug|Insulin LISPRO|Subcutaneous insulin lispro 8 U
16224878|NCT01201265|Drug|Bevacizumab|15 mg/kg iv every 3 weeks
16224879|NCT01201265|Drug|Carboplatin|to an AUC = 2, on days 1 and 8 of each 3-week cycle
16224880|NCT01201265|Drug|Gemcitabine|1000 mg/m2 iv on days 1 and 8 of each 3-week cycle
16226315|NCT01190826|Drug|Placebo|Placebo administered once by inhalation
16224836|NCT01201642|Device|acupuncture|The acupuncture points used were Dicang (ST4), Jiache (ST6), Yangbai (GB14), Xiaguan (ST7), Taiyang (EX-HN5), Quanliao (SI18) and Yifeng (TE17) on the affected side, and Hegu (LI4) bilaterally. For acute stages acupuncture, shallow puncturing is used at facial acupoints and routine puncturing is used at other acupoints. For resting stage acupuncture, penetrative needling is used from Dicang (ST4) to Jiache (ST6) and from Taiyang (EX-HN5) to Quanliao (SI18) 2-3 cun, and routine puncturing is used at other acupoints. Filiform needles (33 - 49.5 mm, 0.32 mm) will be used with moderate stimulation to get an acupuncture sensation, and the needles were retained for 30 minutes, once a day, five times a week, for a total period of four weeks.
16224837|NCT01201642|Other|other treatment|common medicine or other physical treatment which are different from those 5 Arms Previously.
16224838|NCT01201629|Device|t DC stimulation|tDCS is a non-invasive, non-painful technique that modulates cortical excitability. tDCS can induce intracerebral current flow that is sufficiently large to achieve changes in cortical excitability. Thus, tDCS can be applied to humans non-invasively and painlessly to induce focal, lasting but reversible shifts of cortical excitability.
16224839|NCT01201629|Device|tDCStimulation|1 mA of tDCS will be delivered through surface electrodes (25-35 cm2) to the unaffected motor cortex for 30 min prior to a patient's scheduled OT. In the sham group patient will receive stimulation for 30 seconds only.
16224840|NCT01201616|Other|High Fat Low Carbohydrate Diet|55% total energy intake from fats, 17% from protein and 28% from carbohydrate
16224841|NCT01201616|Other|Low fat High Carbohydrate Diet|20% total energy intake from dietary fats, 17% from protein and 63% from carbohydrate
16224842|NCT01201603|Dietary Supplement|orange juice|250ml of orange juice or a sugars matched orange drink
16224843|NCT01201590|Dietary Supplement|High Flavanol Cocoa|cocoa consumed as a 24g dairy based cocoa drink mix, twice a day (mid-morning & early evening on an empty stomach), for 4 weeks.
16224844|NCT01201590|Dietary Supplement|Low Flavanol Cocoa|cocoa consumed as a 24g dairy based cocoa drink mix, twice a day (mid-morning & early evening on an empty stomach), for 4 weeks.
16224845|NCT01201577|Dietary Supplement|Bifidobacterium longum BB536|2 capsules od
16224846|NCT01201577|Dietary Supplement|Active hexose correlated compound (AHCC)|One capsule tds
16224847|NCT01201577|Dietary Supplement|Bifidobacterium longum BB536 and Active hexose correlated compound (AHCC)|One capsule tds (prebiotic) and two capsules od (probiotic)
16224848|NCT01201577|Dietary Supplement|Corn starch placebo capsule|One capsule tds and two capsules od
16224849|NCT01201577|Drug|Azithromycin|250mg od
16224850|NCT01201564|Procedure|intraperitoneal onlay mesh repair|The IPOM technique provides mesh positioning directly into the abdominal cavity onto the defect under laparoscopic control while in sublay position the mesh is placed directly behind des rectus muscle after small incision close to the belly button.
16224851|NCT01201564|Procedure|sublay mesh repair|The IPOM technique provides mesh positioning directly into the abdominal cavity onto the defect under laparoscopic control while in sublay position the mesh is placed directly behind des rectus muscle after small incision close to the belly button.
16224852|NCT01201551|Drug|Brimonidine|Week1, day2: 1 eyedrop/right eye Week2, day1: 1 eyedrop/left eye Week2, day2: 1 eyedrop/left eye
16224853|NCT01201551|Drug|Latanoprost|Week1, day1: 1 eyedrop/right eye Week1, day2: 1 eyedrop/right eye Week2, day2: 1 eyedrop/left eye
16224854|NCT01201551|Drug|Placebo|Week1, day1: 1 eyedrop/left eye Week1, day2: 2 eyedrops/left eye Week2, day1: 1 eyedrop/right eye Week2, day2: 2 eyedrops/right eye
16224855|NCT01201538|Drug|Nilotinib|
16224856|NCT01201525|Procedure|Pulsed dye laser treatment|Part 1 of the surgical scar will be treated with 4 595nm Pulsed dye laser treatments.
16224857|NCT01201525|Procedure|Control|Part 2 of the surgical scar will serve as a within patient control.
16224858|NCT01201499|Drug|Intrathecal morphine|a single dose of intrathecal morphine (ITM, 4 µcg/kg, or ~0.1-0.3 mg morphine before induction of general anesthesia, followed by postoperative patient-controlled morphine analgesia (IV-PCA) for postoperative pain.
16224859|NCT01201499|Drug|Continuous IV remifentanil|a continuous infusion of IV remifentanil supported by a single bolus of IV morphine, 0.2 mg/kg at the end of surgery, followed by IV-PCA morphine.
16224860|NCT01201434|Dietary Supplement|Bio-25 probiotic|2 tablets per day for 6 months
16224861|NCT01201382|Behavioral|IPT-AST|A school-based group prevention program that includes 2 individual pre-group sessions, 8 weekly 90 minute group sessions, an individual mid-group session and 4 booster sessions
16224862|NCT01201382|Behavioral|Group Counseling|Usual group counseling as delivered by school counselors; 1 pre-group session, 1 mid-group session, 8 90-minute group sessions, 4 booster sessions
16224863|NCT01201369|Device|Coronary Stent Cypher|The angioplasty will then be performed in a usual fashion in accordance with the operator's discretion and local protocols.
16224864|NCT01201369|Device|Coronary stent Xience|The angioplasty will then be performed in a usual fashion in accordance with the operator's discretion and local protocols
16224865|NCT01201356|Drug|Fingolimod|0.5 mg/day
16224866|NCT01201343|Drug|Interferon beta-1a|
16224867|NCT01201317|Drug|AZD2423|20 mg tablet
16224868|NCT01201317|Drug|AZD2423|150 mg tablet
16224869|NCT01201317|Drug|Placebo|Placebo
16224870|NCT01201304|Behavioral|Standard exposure|Three 60-second trials of hyperventilation, each followed by diaphragmatic breathing, cognitive reappraisal, and prolonged rest until body sensations have subsided.
16224871|NCT01201304|Behavioral|Enhanced exposure|Three 60-second trials of hyperventilation, each followed by a 15-second rest period and cognitive reappraisal.
16224872|NCT01201304|Behavioral|Intensive exposure|Minimum of eight 60-second hyperventilation trials, each followed by 15-second rest period and cognitive reappraisal. Trials continue until participants rate the probability that their most feared outcome will occur as less than 5% on a 0% to 100% scale.
16224873|NCT01201304|Behavioral|Expressive writing|Individuals randomized to the expressive writing control group will receive a rationale for why writing about emotional issues helps resolve the fear of body sensations. These participants will then be asked to spend the next 25 minutes writing about past emotional issues. Participant writings are confidential and will not be viewed by the experimenter.
16224874|NCT01201291|Other|Normobaric oxygen|Fraction of inspired oxygen
16224875|NCT01201278|Drug|Insulin|Nasal insulin at a dose estimated to be equivalent to 8 IU bioavailable insulin
16224881|NCT01201252|Procedure|Stool sampling|Stool samples will be collected, tested and genotyped for the presence of rotavirus
16224882|NCT01201239|Drug|raltegravir|RAL 400 mg twice daily plus OBT (optimized background therapy) for 48 weeks
16224883|NCT01201226|Other|Removal of half an ovary|Removal of half an ovary
16224884|NCT01201213|Drug|local anaesthetic injection|Single bolus of drug for pain relief in early labour
16224885|NCT01201187|Drug|YY-162|YY-162(Ginkgo extract 30mg+Ginseng extract 50mg) 1T/twice a day(bid) for 8weeks, po medication
16224886|NCT01201187|Drug|Placebo|Placebo 1T/twice a day(bid) for 8weeks, po medication
16224887|NCT01201174|Other|fermented papaya preparation (FPP)|Hemolysis will be assayed by suspending 3 ml of packed RBC in PBS or in the autologous plasma and overnight incubation in the presence of various concentrations of antioxidants such as fermented papaya preparation (FPP) at 37oC in humidified atmosphere of 5% CO2 in air (10). Following 5 min centrifugation at 800 rpm, the supernatants will collected for Hb determination by measuring the absorbance at 540 nm.
16224888|NCT01201161|Drug|Ranibizumab|Intravitreal injection of ranibizumab 0.05 ml (0.5 mg) one week before pars plana vitrectomy
16224889|NCT01201161|Other|Sham injection|Simulation of intravitreal injection one week before pars plana vitrectomy
16224890|NCT01201148|Device|tDCS (Eldith DC-Stimulator (CE certified))|For participants receiving intermittent tDCS or oscillating TES, one electrode will be placed over the left pF3 electrode site (overlying the left dorsolateral prefrontal cortex and identified on the scalp using an EEG cap based on the 10/20 system) and the other over the right temporal area.
16224891|NCT01201122|Drug|Mesalamine|"Dosing: The current standard of care for pediatric UC is 75mg/kg/day of mesalamine (Pentasa) and should be in multiplications of 500mg (half sachets).
~Patients will be randomized in blocks of six stratified by weight groups: 15- <30 kg, 30-40kg, >40kg.
~For body wt. 15- <20kg Arm: Once daily, 1000 mg (morning) and Placebo (0.5 sachet) (evening). Arm: Twice daily, 500mg (morning) and 500mg (evening).
~For body wt: 20- <30 kg Arm: Once daily, 1500mg (morning) and Placebo (0.5 sachet) (evening). Arm: Twice daily, 1000mg (morning) and 500mg (evening).
~For Body wt. 30- <40 kg Arm: Once daily, 2000mg (morning) and Placebo (1 sachet) (evening). Arm: Twice daily, 1000mg (morning) and 1000mg (evening).
~For body wt. ≥40 kg Arm: Once daily, 3000mg (morning) and Placebo (1.5 sachet) (evening). Arm: Twice daily, 1500mg (morning) and 1500mg (evening)."
16224892|NCT01201096|Radiation|177Lutetium|two cycles of 177Lutetium radioreceptor therapy within two month
16224893|NCT01201096|Procedure|Liver transplantation|about 9 month after finishing the receptor therapy liver transplantation takes place
16224894|NCT01201070|Drug|antithrombin III|3000 IU bolus at the time of randomization vs the study group 1000 IU after 8 h (24 h G0) 1000 IU after 16 h (8 h G1) TOTAL 5000/UI 24h
16224895|NCT01201057|Drug|0.5% SPL7013 Gel|Vaginal gel
16224896|NCT01201057|Drug|1.0% SPL7013 Gel|Vaginal gel
16224897|NCT01201057|Drug|3.0% SPL7013 Gel|Vaginal gel
16224898|NCT01201057|Other|Placebo Gel|Vaginal gel
16224899|NCT01201044|Drug|Gemcitabine, Nedaplatin, iV|Gemcitabine, Injection, 1000mg/m2, D1 & D7/ 4weeks/cycle, 2 cycles Nedaplatin, Injection, 75mg/m2, d1/4weeks/cycle, 2 cycles.
16224900|NCT01201044|Radiation|3DCRT|non-PD Patient will be treated with 3DCRT after 2 cycles of chemo.
16224901|NCT01201044|Radiation|3DCRT|non-PD Patient will be treated with 3DCRT after 2 cycles of chemo.
16224902|NCT01201044|Drug|Gemcitabine，Nedaplatin, BAI|"Drug: Gemcitabine, Nedaplatin, iV
~Gemcitabine, Injection, 1000mg/m2, D1/4weeks/cycle, 2 cycles Nedaplatin, Injection, 75mg/m2, d1/4weeks/cycle, 2 cycles. BAI"
16224903|NCT01201018|Drug|Oshadi D, Oshadi R|Oral administration
16224904|NCT01201005|Dietary Supplement|Hydroxycobalamin|Hydroxycobalamin 400 µg (Vitamin B12 depot, Nycomed Pharma ) is given as a single intramuscular injection
16224905|NCT01201005|Dietary Supplement|Sham injection|needle injection without any substance given
16224906|NCT01200992|Biological|EN3348|Induction: 6 weekly instillations. Maintenance: Monthly instillations to Month 12
16224907|NCT01200992|Biological|Mitomycin C|Induction: 6 weekly instillations. Maintenance: Monthly instillations to Month 12
16224908|NCT01200940|Other|Sucralose|sucralose will be given at doses of 68 mg (equivalent to one 12 oz soda) 170 mg (equivalent to two and one-half 12 oz sodas, and 250 mg (equal to 100% of the FDA s acceptable daily intake for a 50kg individual).
16224909|NCT01200940|Other|Aspartame|To determine the impact of sucralose and acesulfame- potassium ( aspartame) together on GLP-1 secretion, satiety, and the rate of intestinal glucose absorption. The doses of sucralose and acesulfame- potassium reflect the sweetener concentrations in the previously used Diet Rite Cola .
16224910|NCT01200940|Other|Acesulfame-Potassium|To determine the impact of sucralose and acesulfame- potassium ( aspartame) together on GLP-1 secretion, satiety, and the rate of intestinal glucose absorption. The doses of sucralose and acesulfame- potassium reflect the sweetener concentrations in the previously used Diet Rite Cola .
16224911|NCT01200940|Other|Control|360 mL of water will be drunk 10 minutes prior to a 75 g oral glucose tolerance test
16224912|NCT01200927|Other|Physical therapy|Perceptual motor therapy, comparing twice weekly to once weekly home program
16224913|NCT01200914|Device|GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface|The 'GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface' will be deployed at the brachiocephalic stenosis.
16224914|NCT01200914|Procedure|PTA alone without use of the GORE VIABAHN|Subject will receive standard of care PTA alone at the brachiocephalic stenosis without deployment of the'GORE VIABAHN® Endoprosthesis with Heparin Bioactive Surface'
16224915|NCT01200901|Drug|Quetiapine|quetiapine XR 100 - 300 mg (flexible dosing)
16224916|NCT01200875|Procedure|Ultrasound-guided platelet-rich-plasma (PRP) injection|One ultrasound-guided intratendinous or intramuscular PRP injection
16224917|NCT01200875|Procedure|Platelet-Rich Plasma (PRP)|One ultrasound-guided PRP injection
16224918|NCT01200862|Drug|Investigational new drug company code: BGS649|
16224919|NCT01200862|Drug|Placebo|
16224920|NCT01200849|Other|Enhanced Label|A prescription drug label that has simplified text, more white space and overall is more patient-friendly.
16224921|NCT01200810|Other|placebo|Given orally
16224922|NCT01200810|Drug|gamma-secretase/Notch signalling pathway inhibitor RO4929097|Given orally
16224923|NCT01200810|Drug|bicalutamide|Given orally
16224924|NCT01200797|Drug|SJG-136|Given IV
16224925|NCT01200797|Other|laboratory biomarker analysis|Correlative studies
16224927|NCT01200771|Procedure|TEP|Intravenous injection of glucose labeled Fluor 18. The patient remains fasted at least 6 hours before the start of the examination. The review lasted 1 hour, during wich the patient should not move.
16224928|NCT01200758|Drug|Rituximab SC|First cycle of rituximab IV infusion (375 mg/m^2) + 7 cycles of rituximab SC (1400 mg; rituximab induction) in administered every 3 weeks. Participants achieving at least PR entered rituximab SC (1400 mg) maintenance therapy once every 8 weeks for 24 months.
16224929|NCT01200758|Drug|Rituximab IV|Eight cycles of rituximab IV infusion (375 mg/m^2; rituximab induction) administered every 3 weeks. Participants achieving at least PR during induction, entered rituximab IV maintenance therapy (375 mg/m^2) once every 8 weeks for 24 months.
16224930|NCT01200758|Drug|Cyclophosphamide|Eight cycles of cyclophosphamide (750 mg/m^2 IV) administered every 3 weeks.
16224931|NCT01200758|Drug|Doxorubicin|Eight cycles of doxorubicin (50 mg/m^2 IV) administered every 3 weeks.
16224932|NCT01200758|Drug|Vincristine|Eight cycles of doxorubicin (1.4 mg/m^2 IV) administered every 3 weeks.
16224933|NCT01200758|Drug|Prednisone/Prednisolone|Eight cycles of prednisone/prednisolone (100 mg/day or 40 mg/m^2/day IV/orally) administered Days 1 to 5 of every 21 days cycle.
16224934|NCT01200745|Drug|Capsaicin patch|Over an four-week period, the treatment group (n=30) uses capsaicin patch (100 mcg/3cc) at the tender point of neck for 12 hours a day; the control group (n=30) receives Hydrogel patch instead of capsaicin patch.
16224935|NCT01200732|Drug|Tadalafil, placebo|20mg tablets, 2 tablets Once daily(i.e 40mg once daily) 20mg placebo 2 tablets once daily
16224936|NCT01200719|Device|transcranial alternating current stimulation (tACS)|Patients in the tACS group received a total of 15 sessions of brain stimulation. The sessions were conducted on weekdays (from Monday to Friday) for three consecutive weeks. Each session lasted 30 minutes. The alternating current stimulations were generated by a CVFT-MG201 machine. Stimulations were delivered by two U-shaped electrodes (approximately 7 cm2) fixed on the patient's left and right mastoid regions (anode or cathode varied depending on polarity of the alternating current). The frequencies (supra-slow waves: < 1 Hz; theta to gamma), levels of intensities (0 to 3mA), and density function (follows a bell-shaped curve; mean intensity ~ 2.1mA) of the current were delivered according to the manufacturer's pre-set random protocol.
16224937|NCT01200706|Drug|Amoxicillin|amoxicillin 50mg/kg/day given in two different administration schemes
16224938|NCT01200693|Device|Sirolimus eluting stent|Implantation of Sirolimus eluting stent
16224939|NCT01200693|Device|Everolimus eluting stent|Implantation of Everolimus eluting stent
16224940|NCT01200693|Device|Zotarolimus eluting stent|Implantation of Zotarolimus eluting stent
16224941|NCT01200654|Drug|Linezolid|Dosage of 600 mg discontinuous administration twice a day was about studies in safety volunteers
16224942|NCT01200641|Drug|Melatonin|"ninety patients scheduled for cataract surgery by phacoemulsification were randomly allocated to three study groups to receive melatonin 6
~mg (Group M, n = 30) , gabapentin 600mg(GroupG, n = 30)or placebo(GroupP, n=30) orally 90 minutes before retrobulbar injection( for all of three groups)."
16224943|NCT01200641|Drug|Gabapentin|"ninety patients scheduled for cataract surgery by phacoemulsification were randomly allocated to three study groups to receive melatonin 6
~mg (Group M, n = 30) , gabapentin 600mg(GroupG, n = 30)or placebo(GroupP, n=30) orally 90 minutes before retrobulbar injection( for all of three groups)."
16224944|NCT01200641|Drug|placebo|"ninety patients scheduled for cataract surgery by phacoemulsification were randomly allocated to three study groups to receive melatonin 6
~mg (Group M, n = 30) , gabapentin 600mg(GroupG, n = 30)or placebo(GroupP, n=30) orally 90 minutes before retrobulbar injection( for all of three groups)."
16224945|NCT01200628|Behavioral|DEPITAC|heteroevaluation scale by a nurse during hospitalization
16224946|NCT01200615|Behavioral|Wording of the explenation on side-effects as part of the informed consent.|Subjects will hear different versions of the description of SSRI's side-effects and the nocebo effect.
16224947|NCT01200602|Drug|megestrol acetate|Given orally in doses of either 10 mg/kg once a day or 5 mg/kg twice a day
16224948|NCT01200602|Other|clinical observation|No treatment is given.
16224949|NCT01200589|Biological|Ofatumumab|liquid concentrate for solution for infusion in glass vials containing 50 mL of solution at a concentration of 20mg/ml to provide 1000 mg per vial.
16224950|NCT01200589|Biological|Rituximab|sourced locally from commercial stock
16224951|NCT01200589|Biological|Ofatumumab|Four weekly doses of single agent ofatumumab (1000 mg), followed by ofatumumab (1000 mg) every two months for four additional doses.
16224952|NCT01200589|Biological|Rituximab|Four weekly doses of single agent rituximab (375 mg/m2), followed by rituximab (375 mg/m2) every two months for four additional doses.
16224953|NCT01200563|Device|MIST Therapy|Low-frequency, non-contact ultrasound system delivering therapeutic ultrasound via a fine saline mist to the wound bed without direct contact of the device with the body.
16224954|NCT01200563|Device|Vacuum Assisted Closure|Controlled negative pressure (vacuum) delivering negative (sub-atmospheric) pressure to the wound site applied by a tubing which decompresses a foam dressing, continuously or intermittently depending on wound type.
16224955|NCT01200563|Device|MIST Therapy and Negative Pressure Wound Therapy|MIST Therapy will be provided 3 times per week, NPWT will be provided according to the manufacturer's recommended guidelines.
16224956|NCT01200537|Drug|Estradiol|This group of patients will receive estradiol patches prior to the IVF cycle.
16224957|NCT01200537|Drug|Oral Contraceptive Pills (OCP)|This group of patients will receive OCP's prior to the IVF cycle.
16224958|NCT01200524|Drug|AZD2423|20 mg tablet
16224959|NCT01200524|Drug|AZD2423|50 mg tablet
16224960|NCT01200524|Drug|Placebo|Placebo
16224961|NCT01200511|Device|AcrySof® IQ ReSTOR® +3.0 D Multifocal Toric IOL|Multifocal IOL with extended secondary focal point and astigmatism correction implanted for long-term use over the lifetime of the cataract patient
16224962|NCT01200498|Drug|SB939|Starting dose 60 mg by mouth every other day, three times weekly for 3 weeks.
16224963|NCT01200485|Drug|Rasburicase|"Cycle 1: 3 mg/kg by vein on Day 1, plus as needed dosing (until day 5), during Cycle 1.
~Cycle 2 Arm A: 0.15 mg/kg by vein on Day 1 of Cycle 2, plus as needed dosing (until day 5), during Cycle 2."
16224964|NCT01200485|Drug|Allopurinol|Arm B: 300 mg/day by vein, as standard of care, over 30 minutes each day on days 1-5 of cycle 2 in 21 day cycle.
16224965|NCT01200472|Drug|Apremilast|Apremilast is supplied as 10 mg capsules for oral administration. After a 7-day titration phase patients will receive 20 mg PO BID apremilast.
16224966|NCT01200472|Drug|Placebo|Placebo capsules identical to apremilast
16224967|NCT01200459|Behavioral|Social/mobile weight loss promotion intervention.|Social/mobile intervention for weight loss promotion, compared to control group.
16224968|NCT01200446|Dietary Supplement|Docosahexaenoic Acid|8 docosahexaenoic acid (4.0 grams) capsules per day for 3 weeks.
16224969|NCT01200446|Dietary Supplement|Placebo Docosahexaenoic Acid|8 placebo docosahexaenoic acid (corn and soy oil blend) capsules per day for 3 weeks.
16224970|NCT01200433|Drug|dexmedetomidine|Patients assigned to dexmedetomidine will be given a mg/kg bolus over 10-20 minutes; subsequently, an infusion will be titrated to between 0.4-0.6 mcg/kg/hr to maintain an adequate level of sedation during the procedure.
16224971|NCT01200433|Drug|propofol|Patients assigned to propofol will be given an infusion dose of 50-75 µ/kg/min which will be titrated to the patient's response
16224972|NCT01200420|Drug|miravirsen|SC injection
16224973|NCT01200420|Drug|saline|SC injection
16224974|NCT01200407|Drug|Amlodipine + Olmesartan medoxomil|start dose is 5/20 mg, which can then be uptitrated to 5/40 mg up to 10/40 mg if BP goal is not reached during the 4 week follow-up
16224975|NCT01200394|Drug|PF-00489791|Tablet, 20 mg once daily for 12 weeks
16224976|NCT01200394|Drug|Placebo|Tablet, placebo once daily for 12 weeks
16224977|NCT01200381|Other|Quarterly remote follow ups and remote monitoring|Quarterly remote follow ups and remote monitoring
16224978|NCT01200381|Other|Quarterly remote follow ups + additional phone calls and remote monitoring|Quarterly remote follow ups + additional phone calls and remote monitoring
16224979|NCT01200381|Other|Quarterly in clinic follow ups and remote monitoring|Quarterly in clinic follow ups and remote monitoring
16224980|NCT01200368|Biological|13-valent pneumococcal conjugate vaccine (13vPnC)|0.5 mL per dose, 4 doses
16224981|NCT01200368|Biological|diphtheria, tetanus, and acellular pertussis vaccine (DTaP)|0.5 mL per dose, 4 doses
16224982|NCT01200368|Biological|7-valent pneumococcal conjugate vaccine (7vPnC)|0.5 mL per dose, 4 doses
16224983|NCT01200368|Biological|DTaP|0.5 mL per dose, 4 doses
16224984|NCT01200368|Biological|DTaP|0.5 mL per dose, 4 doses
16224985|NCT01200355|Drug|micafungin|Micafungin 100 mg intravenously once daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy.
16224986|NCT01200355|Drug|posaconazole|Posaconazole 400 mg orally twice daily. Randomized treatment will be initiated 24-48 h after completion of the last dose of chemotherapy.
16224987|NCT01200342|Drug|Genasense|900 mg by vein over 1 hour on Days 1, 3, and 5 of a 21 day cycle.
16224988|NCT01200342|Drug|Paclitaxel|175 mg/m^2 by vein over 3 hours on Day 3 of a 21 day cycle following Genasense.
16224989|NCT01200342|Drug|Carboplatin|"Carboplatin starting dose in mg (AUC= 6) is administered over 30 minutes IV Piggyback (IVPB). Carboplatin will be dosed after Paclitaxel dose on Day 3 every 3 weeks.
~The total dose of Carboplatin is calculated using a formula based upon a participant's glomerular filtration rate (GFR in mL/min) and Carboplatin target area under the concentration (AUC)."
16224990|NCT01200329|Drug|Gemcitabine|2775 mg/m2 by vein over about 3 hours on days -8 and -3.
16224991|NCT01200329|Drug|Busulfan|"32 mg/m2 test dose with PKs as outpatient and on day -10 as inpatient
~AUC 4,000 by vein over about 3 hours on days -8 to -5."
16224992|NCT01200329|Drug|Melphalan|60 mg/m2 by vein over about 30 minutes on days -3 and -2.
16224993|NCT01200329|Procedure|Stem Cell Transplantation|Infusion of stem cells on Day 0.
16224994|NCT01200329|Drug|Palifermin|60 mg/kg by vein over 30 seconds daily, Days -12 to -10 and Days 0 to 2.
16224995|NCT01200316|Procedure|Standard of Care|Post surgical patient to sit in a non-rocking chair for at least sixty minutes per day, and ambulating at least three times per day.
16224996|NCT01200316|Procedure|Rocking Chair Motion|Post surgical patient to rock in a rocking chair in 10-20 minute increments for at least sixty minutes per day, and ambulating at least three times per day.
16224997|NCT01200316|Behavioral|Questionnaire|Beginning on day of surgery till discharge (3-5 days)
16224998|NCT01200303|Procedure|non-cathartic CTC|non-cathartic, CAD-assisted CT Colonography
16224999|NCT01200290|Drug|LY2127399|120 milligrams (mg) administered subcutaneously every 4 weeks for 20 weeks. A loading dose of 240 mg will be given as the first dose of the study medication
16225000|NCT01200277|Procedure|percutaneous vertebroplasty|Using fluoroscopic guidance, the practitioner infiltrates the skin and subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae with 1% lidocaine and infiltrates the periosteum of the pedicles with 0.25% bupivacaine (marcaine. For the vertebroplasty procedure, 11-gauge or 13-gauge needles are passed into the central aspect of the target vertebra or vertebrae. Bone cement is prepared on the bench and injected under constant fluoroscopy into the vertebral body. Injection is stopped when the PMMA reaches to the posterior aspect of the vertebral body or leaks into an extraosseous space, such as the intervertebral disk or an epidural or paravertebral vein.
16225001|NCT01200277|Procedure|sham procedure|Using fluoroscopic guidance, the practitioner infiltrates the skin and subcutaneous tissues overlying the pedicle of the target vertebra or vertebrae with 1% lidocaine and infiltrates the periosteum of the pedicles with 0.25% bupivacaine (marcaine. During the sham intervention, verbal and physical cues, such as pressure on the patient's back, are given, and the methacrylate monomer is opened to simulate the odor associated with mixing of cement, but the needle is not placed and cement is not injected.
16225002|NCT01200264|Drug|apremilast|apremilast 10 mg tablets with dose titration to 30 mg BID for 169 days
16225003|NCT01200251|Drug|Bimatoprost eyelash gel|Bimatoprost 0.03% solution was compounded into a gel - patients used on eyelash margin once daily placing gel with a fingertip or Q-tip for 6 months
16225004|NCT01200238|Drug|STA-9090|
16225005|NCT01200212|Drug|Taxane, Avastin|Taxane (Investigator can choose between Paclitaxel (80 mg/m2 weekly or Docetaxel 75 mg/m2 day 1 q 22) + Bevacizumab (15mg/kg) i.v. day 1 q 22 Given until progression, unacceptable toxicity, patient's request or withdrawal from study
16225006|NCT01200212|Drug|Taxane, Avastin, Xeloda|Taxane (Investigator can choose between Paclitaxel (80 mg/m2 weekly or Docetaxel 75 mg/m2 day 1 q 22) + Bevacizumab (15mg/kg) i.v. day 1 q 22 + Capecitabine 1800 mg/m2 day 1-14 q22 Given until progression, unacceptable toxicity, patient's request or withdrawal from study
16225007|NCT01200186|Drug|EV/DNG (Qlaira, BAY86-5027)|At the discretion of the attending physician
16225008|NCT01200186|Drug|Progestin Only Pills|At the discretion of the attending physician
16225009|NCT01200173|Other|1-Fermented dairy product containing the probiotic Lactobacillus casei DN-114 001 (Actimel®)|
16225010|NCT01200173|Other|2-Non fermented dairy product (control)|
16225011|NCT01200160|Drug|Niacin|
16225012|NCT01200147|Procedure|Biopsy|
16225013|NCT01200147|Procedure|Dilation|
16225014|NCT01200134|Other|18F-FMISO PET-scanning|Other: 18F-FMISO PET-scanning 18F-FMISO PET-scanning: 18F-FMISO PET-scanning will be performed at the same place following the same protocol as mentioned above. However, the 20-minutes period of PET images acquisition will start 120 minutes after the 18F-FMISO bolus injection (0.05 mCi/kg).
16225015|NCT01200121|Drug|Bevacizumab|Patients will receive paracentesis as needed for symptom con¬trol. In addition, patients will receive up to 4 intraperitoneal administrations of 400 mg Bevacizumabafter paracentesis has been performed. During the 8-week treatment period, a minimum interval of 14 days will be kept between applications of the study medication.
16225016|NCT01200121|Other|Placebo|Patients will receive paracentesis as needed for symptom con¬trol. In addition, patients will receive up to 4 intraperitoneal administrations of Placebo after paracentesis has been performed. During the 8-week treatment period, a minimum interval of 14 days will be kept between applications of the study medication.
16225017|NCT01200108|Drug|Budesonide|
16225018|NCT01200108|Drug|Budesonide|
16225019|NCT01200108|Drug|Budesonide|
16225020|NCT01200069|Drug|Placebo infusion|Identically appearing placebo dose administered IV prior to ECT and subsequently on ECT treatments 2 and 3
16225021|NCT01200069|Drug|ibuprofen intravenous|IV ibuprofen 800mg/8ml given over 30 minutes prior to ECT and subsequently on ECT treatments 2 and 3
16225022|NCT01200056|Drug|Atorvastatin 10mg versus 40mg.|2 arms comparing atorvastatin 10mg daily for 6 months to atorvastatin 40mg daily for 6 months. The primary endpoint would be the 6 months VH-IVUS findings and clinical outcomes.
16225023|NCT01200043|Other|fructose restriction diet|fruits and vegetables only
16225024|NCT01200030|Behavioral|electrical stimulation with exercises|electrical stimulation with exercises
16225025|NCT01200030|Behavioral|placebo stimulation with exercises|placebo stimulation with exercises
16225026|NCT01200017|Biological|CD34+ enriched, T Cell Depleted donor stem cell product|stem cell transplant
16225027|NCT01200004|Drug|Azacitidine|75 mg/m2 subcutaneous or by vein on days 1 - 5 of a 28 day cycle.
16225028|NCT01200004|Drug|Lenalidomide|Starting dose 10 mg by mouth daily on days 1-21 of a 28 day cycle, until maximum tolerated dose (MTD) reached. MTD used for combination and expansion groups.
16225029|NCT01200004|Drug|Grifola Frondosa|3 mg/kg by mouth twice a day on days 1 - 21 of a 28 day cycle.
16225030|NCT01199978|Radiation|Fractionated proton radiation|Given daily for approximately 5.5 weeks
16225031|NCT01199965|Drug|MAP0004|1.0mg MAP0004 via inhalation at Visit 2 or 3 as per protocol
16225032|NCT01199965|Drug|IV DHE|IV DHE administered at Visit 2 or 3 as per protocol
16225033|NCT01199952|Behavioral|Treatment group: receives counseling phone call intervention|Subjects in the treatment arm will receive a phone call from a health educator to assist with contraception, 3 to 4 weeks after enrollment.
16225034|NCT01199939|Drug|Etravirine|400mg once daily orally for 48 weeks
16225035|NCT01199939|Drug|Ritonavir|100mg once daily orally for 48 weeks
16225036|NCT01199939|Drug|Darunavir|800mg once daily orally for 48 weeks
16225037|NCT01199926|Dietary Supplement|Vitamin D|4000 IU of vitamin D per day for 12 weeks.
16225038|NCT01199926|Drug|Placebo|Placebo (microcrystalline cellulose) ingestion each day for 12 weeks.
16225039|NCT01199913|Other|The intervention will be Mini-Mental Status Examination (MMSE)|A questionnaire given to the study patient before and after the anesthetic at 1, 6 and 24 hours.
16225040|NCT01199900|Drug|PF-04171327|25 mg extemporaneous preparation of oral solution predosed 8 hours prior to Oral Glucose Tolerance Test (OGTT)
16225041|NCT01199900|Drug|PF-04171327|25 mg extemporaneous preparation of oral solution predosed 12 hours prior to Oral Glucose Tolerance Test (OGTT)
16225042|NCT01199900|Drug|Prednisone|5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)
16225043|NCT01199900|Drug|PF-04171327|3 mg extemporaneous preparation of oral solution predosed at time selected from Part 1 prior to Oral Glucose Tolerance Test (OGTT)
16225044|NCT01199900|Drug|PF-04171327|10 mg extemporaneous preparation of oral solution predosed at time selected from Part 1 prior to Oral Glucose Tolerance Test (OGTT)
16225045|NCT01199900|Drug|Prednisone|5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)
16225046|NCT01199900|Drug|Prednisone|5 mg tablets predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)
16225047|NCT01199887|Drug|IW001|IW001, 0.1 mg, 0.5 mg, 1.0 mg PO daily for 24 weeks.
16225048|NCT01199874|Biological|Rotavirus vaccine|live attenuated oral rotavirus vaccine; lyophilized; 1 ml
16225049|NCT01199861|Drug|Fingolimod|Fingolimod 0.5 mg capsules for oral administration.
16225050|NCT01199861|Drug|Placebo|Matching placebo capsules for oral administration.
16225051|NCT01199861|Biological|Seasonal influenza vaccine|Commercially available injectable influenza vaccine for the 2010/11 influenza season.
16225052|NCT01199861|Biological|Tetanus toxoid vaccine|Commercially available tetanus toxoid vaccine booster injection.
16225053|NCT01199848|Dietary Supplement|Placebo|whole milk shake without strawberry powder served with the high fat/carbohydrate test meal
16225054|NCT01199848|Dietary Supplement|10G|whole milk shake with 10g strawberry powder served with the high fat/carbohydrate test meal
16225055|NCT01199848|Dietary Supplement|20G|whole milk shake with 20 strawberry powder served with the high fat/carbohydrate test meal
16225056|NCT01199848|Dietary Supplement|40G|whole milk shake with 40g strawberry powder served with the high fat/carbohydrate test meal
16225057|NCT01199848|Dietary Supplement|Placebonofiber|Placebo without Fiber
16225058|NCT01199835|Other|High Calcium intake from dairy products|High dietary intake of calcium from dairy products (~1200 mg/d)
16225117|NCT01199458|Drug|saline|The amount of saline will be equal the amount (in ml) of the study-drug (alfentanil)in order to keep it blinded.
16226961|NCT01185886|Genetic|gene expression analysis|
16225059|NCT01199822|Biological|Olaratumab|Cohort 1 10 milligrams/kilogram (mg/kg) intravenously (IV) administered on Days 1 and 8, every 3 weeks; Cohort 2 20 mg/kg IV administered every 2 weeks; Cohort 3 15 mg/kg IV administered on Days 1 and 8, every 3 weeks
16225060|NCT01199809|Drug|Placebo|multiple doses
16225061|NCT01199809|Drug|RO5310074|multiple ascending doses
16225062|NCT01199783|Drug|Daptomycin|Infusion (6 mg/kg/bodyweight) once daily
16225063|NCT01199783|Drug|Vancomycin|vancomycin once daily (effective blood-plasma concentration of 15 mg/L)
16225064|NCT01199770|Other|Control, small|control pasta, small portion
16225065|NCT01199770|Other|Experimental B, small|experimental pasta, small portion
16225066|NCT01199770|Other|Experimental pasta C, small|experimental pasta C, small portion
16225067|NCT01199770|Other|control, medium|control pasta, medium portion
16225068|NCT01199770|Other|experimental pasta B, medium|experimental pasta B, medium portion
16225069|NCT01199770|Other|experimental pasta C, medium|experimental pasta C, medium portion
16225070|NCT01199770|Other|NL|no pasta, water only
16225071|NCT01199757|Drug|Fluticasone furoate|cohort of patients receiving fluticasone furate
16225072|NCT01199757|Drug|mometasone furoate|cohort receiving mometasone furoate
16225073|NCT01199757|Drug|fluticasone propionate|cohort of patients on fluticasone propionate
16225074|NCT01199744|Drug|zanamivir|zanamivir
16225075|NCT01199731|Drug|GSK2248761 100 mg once daily|1 100mg capsule OAD plus matching placebo
16225076|NCT01199731|Drug|GSK2248761 200 mg once daily|2 100mg capsules OAD
16225077|NCT01199731|Drug|Etravirine|2 100mg tablets twice daily
16225078|NCT01199718|Drug|CX-4945|CX-4945 capsules, administered orally,as escalating doses. Dose schedule: four times daily for 21 consecutive days every 28 days.
16225079|NCT01199705|Biological|Immune Globulin Subcutaneous (Human) (SCIG)|IgPro20 is a 20% (weight per volume [w/v]) liquid formulation of human SCIG. Subjects will receive weekly infusions of IgPro20 at a weekly dosage calculated based on previous IVIG treatment.
16225080|NCT01199679|Procedure|Mucosectomy|Endoscopic mucosal resection in the upper GI tract.
16225081|NCT01199679|Procedure|Rubber Band Ligation|Endoscopically ligate esophageal varices at or above the gastroesophageal junction or to ligate internal hemorrhoids.
16225082|NCT01199666|Other|Text message|text message appointment and immunization reminders
16225083|NCT01199653|Procedure|Operative treatment|Fracture stabilization with stainless steel reconstruction plate and screws. After the operation arm is immobilized to a sling for three weeks. Pendulum movements are allowed immediately.
16225084|NCT01199653|Procedure|Non-operative treatment with arm immobilised to a sling|Arm is immobilised to a sling for three weeks. Pendulum movements are allowed immediately.
16225085|NCT01199640|Drug|MLN1202|Patients received 5 intravenous (IV) infusions of the study drug. The first 3 infusions were administered at 15-day intervals, followed by 2 infusions at 30-day intervals. Patients were randomized to receive 1 of 2 doses of MLN1202 (4mg/kg or 8mg/kg).
16225086|NCT01199627|Drug|A|"Group A: 1st dose 15mg/kg of TXA (tranexamic acid) in 100ml saline 0.9% after the completion of regional anesthesia, and before the start of surgery.
~2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after the first administration."
16225087|NCT01199627|Drug|B|"Group B: 1st dose: 10mg/kg of TXA(tranexamic acid) in 100ml 0.9% saline after the completion of regional anesthesia, and before the start of surgery.
~2nd dose: intravenous infusion over 10 minutes of 10mg/kg of TXA in 100ml saline 0.9% at three hours after the first administration."
16225088|NCT01199627|Drug|C|"Group C: 1st dose: intravenous infusion over 10 minutes in 100ml of 0.9% saline after the completion of regional anesthesia, and before the start of surgery.
~2nd dose: intravenous infusion over 10 minutes in 100ml of saline 0.9% at three hours after the first administration."
16225089|NCT01199614|Drug|open-label PTH(1-84)|open label PTH(1-84) at either 25mcg every other day, 25mcg every day, 50mcg daily, 75mcg daily, or 100mcg daily
16225090|NCT01199601|Behavioral|Concentrated postpartum counseling|Intrapartum testing and concentrated postpartum counseling for the female patient from a retrained provider focusing on correct breastfeeding practices, postpartum contraception, and infant vaccination.
16225091|NCT01199588|Drug|Nexagon® Low Dose|Weekly, topical application of Nexagon® low dose used with compression dressings.
16225092|NCT01199588|Drug|Nexagon® High Dose|Weekly, topical application of Nexagon® high dose used with compression dressings.
16225093|NCT01199588|Drug|Nexagon® Vehicle|Weekly, topical application of Nexagon® Vehicle used with compression dressings.
16225094|NCT01199575|Drug|Revlimid|
16225095|NCT01199575|Drug|Rituximab|
16225096|NCT01199562|Procedure|infection prophylaxis and management|Undergo infection prophylaxis and management
16225097|NCT01199562|Other|laboratory biomarker analysis|Correlative studies
16225098|NCT01199562|Other|flow cytometry|Correlative studies
16225099|NCT01199562|Genetic|DNA analysis|Correlative studies
16225100|NCT01199562|Genetic|RNA analysis|Correlative studies
16225101|NCT01199562|Procedure|management of therapy complications|undergo infection prophylaxis and management
16225102|NCT01199562|Drug|ganciclovir|Given IV
16225103|NCT01199562|Drug|valganciclovir|Given orally
16225104|NCT01199562|Drug|foscarnet sodium|Given orally
16225105|NCT01199562|Procedure|antiviral therapy|undergo infection prophylaxis and management
16225106|NCT01199562|Genetic|polymerase chain reaction|Correlative studies
16225107|NCT01199562|Genetic|protein expression analysis|Correlative studies
16225108|NCT01199523|Drug|Placebo|oral
16225109|NCT01199523|Drug|mirabegron|oral
16225110|NCT01199523|Drug|moxifloxacin|oral
16225111|NCT01199510|Other|FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops) plus standard of care|Patients will dose 4 times daily for 30 days with FID 112903 and follow routine standard of care post-operatively
16225112|NCT01199510|Other|Standard of Care|Post Cataract Surgery Standard of Care
16225113|NCT01199497|Drug|Group 1|fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup).
16225114|NCT01199497|Drug|Group 2|placebo
16225115|NCT01199484|Other|Cow's milk|
16225116|NCT01199458|Drug|alfentanil|20 mikrogr/kg
16225118|NCT01199445|Dietary Supplement|Triple fortified extruded tice (Fe, Zn and vitamin A)|Triple fortified extruded rice (Fe, Zn and vitamin A)will be mix at ratio of 1:50 with normal rice then give to children at school lunch meal for 60 days.
16225119|NCT01199432|Drug|5-FU（intravenous infusion）+epirubicin+cyclophosphamide|5-FU 200mg/m2 per day from day 1 to day 28 （Continuous intravenous infusion）; epirubicin 65mg/m2 per day on day 1 and day 8 and cyclophosphamide 500mg/m2 per day on day 1 and day 8 ; every 28 days as a cycle. Total four cycles is needed
16225120|NCT01199432|Drug|5-FU（intravenous bolus）+epirubicin+cyclophosphamide|5-FU 500mg/m2 per day on day 1 and day 8（intravenous bolus）; epirubicin 65mg /m2 per day on day 1 and day 8 and cyclophosphamide 500mg/m2 per day on day 1 and day 8 ; every 28 days as a cycle. Total four cycles is needed.
16225121|NCT01199432|Drug|epirubicin+cyclophosphamide|epirubicin 65mg/m2 per day on day 1 and day 8 and cyclophosphamide 500mg/m2 per day on day 1 and day 8 ; every 28 days as a cycle. Total four cycles is needed.
16225122|NCT01199419|Procedure|comparison of PCI vs. CABG in multivessel disease|invasive treatment of coronary artery disease
16225123|NCT01199406|Drug|Levobupivacaine|0.125% levobupivacaine 80 mL (100 mg) intraoperative, 20 mL subcutaneously and 60 mL intraperitoneally
16225124|NCT01199380|Behavioral|Standard Treatment|Participants will receive a standard, group smoking cessation treatment, based on the most recent clinical practice guideline for treating tobacco use from the U.S. Department of Health and Human Services. Treatment will be delivered in 8, 60-minute group sessions over an 8-week period. Patients in ST will also keep a weekly written journal throughout treatment elaborating on observations about the day's events, their thoughts, feelings, and insights about their reactions to these events as a means to equate for time spent on daily activity monitoring in the BATS condition.
16225125|NCT01199380|Behavioral|Behavioral Activation Treatment for Smoking|BATS is focused on identifying life areas, values, and daily activities to help one live according to his or her values. Treatment will be delivered in 8, 60-minute group sessions over an 8-week period.
16225126|NCT01199380|Drug|Transdermal Nicotine Patch|8 weeks of the Transdermal Nicotine Patch Nicoderm CQ at 24 hour doses of 21, 14, and 7 mg respectively depending on participant's initial level of nicotine use. Nicotine patch dose will decrease at 2 or 4 week increments also specific to the participant's initial nicotine level.
16225127|NCT01199367|Drug|KW-2450 in combination with lapatinib and letrozole|Three subjects will be assigned to each of 4 sequential cohorts. Dose escalation may proceed once at least 3 subjects have completed 30 days of study treatment. Subjects who withdraw prior to completing Day 30 for reasons other than DLT will be replaced. If a DLT is observed, additional subjects may be enrolled so that up to 6 subjects are enrolled at that dose level.
16225128|NCT01199354|Procedure|Mastectomy, preservation of the skin envelope,followed by immediate reconstruction with autologous latissimus dorsi flap.|Mastectomy, preservation of the skin envelope, removal of the nipple-areolar complex and dissection of the axillary lymph nodes followed by immediate reconstruction with autologous latissimus dorsi flap with or without prosthesis.
16225129|NCT01199341|Drug|AZD1981|100 mg per oral, twice daily for 14 days
16225130|NCT01199341|Drug|Warfarin|10 x 2.5 mg per oral, once daily at day 1 and day 15
16225131|NCT01199341|Drug|AZD1981|4 x 100 mg per oral, twice daily for 14 days
16225132|NCT01199328|Drug|Aspirin|81mg Tablet oral, once daily
16225133|NCT01199328|Drug|Esomeprazole|20 mg Tablet oral, once daily
16225134|NCT01199315|Drug|AZD1446|oral capsule, Moderate Release
16225135|NCT01199315|Drug|Placebo|oral capsule
16225136|NCT01199302|Drug|AMG 827|350 mg AMG 827 administered intraveneously at baseline, week 4, and every 4 weeks thereafter.
16225137|NCT01199289|Drug|AMG 827|210 mg AMG 827 SC
16225138|NCT01199289|Drug|Placebo|Placebo SC
16225139|NCT01199289|Drug|AMG 827|140 mg AMG 827 SC
16225140|NCT01199289|Drug|AMG 827|280 mg AMG 827 SC
16225141|NCT01199276|Drug|Xenon|Group A: xenon 60% (55%-65%)(1 MAC) in oxygen (FiO2 = 0.35-0.45)
16225142|NCT01199276|Drug|Sevoflurane|Group B: sevoflurane 1.1-1.4%(1 MAC) in oxygen (FiO2 = 0.35-0.45) and Medical air
16225143|NCT01199263|Other|Laboratory Biomarker Analysis|Correlative studies
16225144|NCT01199263|Drug|Paclitaxel|Given IV
16225145|NCT01199263|Biological|Pelareorep|Given IV
16225146|NCT01199250|Other|Laboratory Biomarker Analysis|Correlative studies
16225147|NCT01199237|Drug|Sevoflurane|Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water
16225148|NCT01199237|Drug|Desflurane|Protective airway reflexes will be tested, judged by subject's ability to swallow 20 mL water
16225149|NCT01199237|Drug|Rocuronium|
16225150|NCT01199237|Drug|Neostigmine|
16225151|NCT01199237|Drug|Glycopyrrolate|
16225152|NCT01199224|Drug|veliparib|veliparib formulation A
16225153|NCT01199224|Drug|veliparib|veliparib formulation B
16225154|NCT01199224|Drug|veliparib|veliparib formulation C
16225155|NCT01199224|Drug|veliparib|veliparib formulation C
16225156|NCT01199211|Other|Exercise training, women, marathon|Prospective study with no intervention in women who have volunteered to run a full marathon or a half-marathon. Each subject will serve as own control. Each subject will be studies at 3 stages: baseline, after at least 12 weeks of training for the marathon (we will not provide training), 6 weeks after running the marathon.
16225157|NCT01199198|Drug|Tolvaptan|Starting dose 15 mg by mouth once a day for 14 days.
16225158|NCT01199198|Drug|Placebo|Placebo by mouth once a day for 14 days.
16225159|NCT01199185|Behavioral|Smoking Cessation|All participants will receive a smoking cessation intervention via the Proactive TARGIT Quit Line. Participants will receive access to the TARGIT Smoking Cessation Handbook which will be a useful tool to guide them through the quitting process and highlight the major points reviewed in all counseling sessions. As part of TARGIT all participants will receive nicotine replacement therapy (NRT).
16225245|NCT01198548|Drug|oxaliplatin|Given IV
16225246|NCT01198548|Other|pharmacological study|Correlative studies
16225247|NCT01198535|Biological|Cetuximab|Given IV
16225248|NCT01198535|Drug|Gamma-Secretase Inhibitor RO4929097|Given PO
16225249|NCT01198535|Other|Laboratory Biomarker Analysis|Correlative studies
16225250|NCT01198535|Other|Pharmacological Study|Correlative studies
16225600|NCT01195779|Biological|GSK Bio's influenza vaccine GSK2321138A|Intramuscular injections
16225160|NCT01199185|Behavioral|Smoking Cessation plus Weight Loss|All participants will receive a smoking cessation intervention via the Proactive TARGIT Quit Line. Participants will receive access to the TARGIT Smoking Cessation Handbook which will be a useful tool to guide them through the quitting process and highlight the major points reviewed in all counseling sessions. As part of TARGIT all participants will receive nicotine replacement therapy (NRT). Participants in the Intervention Group will also receive a Behavioral Weight Loss/ Weight Gain Prevention Intervention delivered via interactive technology. The Intervention group will receive 16 weekly webinar sessions beginning 7 weeks after randomization via Cisco WebEx. The webinar sessions will present the behavioral weight loss/ weight gain prevention program. After the 16 weekly sessions, the webinar sessions will then be scheduled monthly for the next 6 months then quarterly thereafter for 12 months.
16225161|NCT01199172|Behavioral|voice hygiene|subjects will receive voice hygiene training
16225162|NCT01199172|Behavioral|VH + VP|subjects will be trained in voice hygiene and voice production training
16225163|NCT01199159|Drug|Misoprostol|400mcg misoprostol given sublingually 30 minutes before total abdominal hysterectomy
16225164|NCT01199159|Drug|Vitamin B 6|20mg vitamin B6 given sublingually 30 minutes before total abdominal hysterectomy
16225165|NCT01199146|Drug|Abiraterone acetate|Abiraterone acetate 1000 mg by mouth per day
16225166|NCT01199133|Drug|Dpte and Dfar Allergen Extracts|300 IR, once a day, for one year.
16225167|NCT01199133|Drug|placebo|once a day, for one year.
16225168|NCT01199120|Dietary Supplement|Omega 3|measure of efficacy of omega-3 fatty acids supplement on cognition and academic performance in children attending elementary school.
16225169|NCT01199107|Behavioral|Prolonged Exposure|75-90 minute weekly psychotherapy sessions x 12 weeks, focused on gradually confronting distressing trauma-related memories and reminders
16225170|NCT01199107|Behavioral|Exercise|30 minutes of moderate-intensity treadmill exercise prior to the Prolonged Exposure
16225171|NCT01199107|Behavioral|Wellness Intervention|30 minutes of wellness education prior to Prolonged Exposure
16225172|NCT01199081|Drug|Dronedarone|"Pharmaceutical form: tablet
~Route of administration: oral (together with meal)
~Dose regimen: 400 mg twice daily"
16225173|NCT01199068|Drug|CS-7017|CS-7017 from 0.25 mg to 0.50 mg twice daily
16225174|NCT01199068|Drug|Erlotinib|Erlotinib 150 mg once daily
16225175|NCT01199055|Drug|CS-7017|Drug: CS-7017 from 0.25 mg BID to 0.50 mg BID for up to 4~6 cycles (1 cycle: 3 weeks)
16225176|NCT01199055|Drug|Carboplatin|Drug: Carboplatin IV, AUC of 6 mg/mL*min, once every three weeks for up to 4~6 cycles (1 cycle: 3 weeks)
16225177|NCT01199055|Drug|Paclitaxel|Drug: Paclitaxel IV, 200mg/m^2, once every three weeks for up to 4~6 cycles (1 cycle: 3 weeks)
16225178|NCT01199042|Device|BiPAP autoSV Advanced|The sleep apnea device will be set-up in automatic mode with the settings wide open for the entire night.
16225179|NCT01199029|Drug|PF-04308515|10 mg extemporaneous preparation of oral solution predosed 8 hours prior to Oral Glucose Tolerance Test(OGTT)
16225180|NCT01199029|Drug|PF-04308515|10 mg extemporaneous preparation of oral solution predosed 12 hours prior to Oral Glucose Tolerance Test(OGTT)
16225181|NCT01199029|Drug|Prednisone|5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)
16225182|NCT01199029|Drug|PF-04308515|X mg of Pf-04308515 extemporaneous oral solution predosed at selected time from Part 1 prior to Oral Glucose Tolerance Test (OGTT)
16225183|NCT01199029|Drug|PF-04308515|Y mg of Pf-04308515 extemporaneous oral solution predosed at selected time from Part 1 prior to Oral Glucose Tolerance Test (OGTT)
16225184|NCT01199029|Drug|Prednisone|5 mg tablet predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)
16225185|NCT01199029|Drug|Prednisone|20 mg (5 mg tablets) predosed at 8 hours prior to Oral Glucose Tolerance Test (OGTT)
16225186|NCT01199016|Procedure|Tympanocentesis|To be performed as needed on children presenting with acute otitis media
16225187|NCT01199016|Procedure|Nose/throat swab|To be performed at every study visit
16225188|NCT01199016|Biological|Observational|Observational Study Only
16225189|NCT01198990|Behavioral|Group 1|Subjects will be randomized to the small change eating strategy, a physical activity goal and will receive the positive affect/self affirmation component.
16225190|NCT01198990|Behavioral|Group 2|Subjects will be randomized to the small change eating strategy and a physical activity goal.
16225191|NCT01198977|Behavioral|Brief telephone-based counseling|Brief telephone-based counseling using Motivational Interviewing and physical activity goal setting and problem solving
16225192|NCT01198977|Other|Education counseling|Mailed informational video of exercise programs
16225193|NCT01198964|Procedure|Low-level cortical stimulation|A couple of electrodes will be stimulated (at a lower level than the stimulation used for standard care) over a period of 4-12 hours based on the signals defined by the motor or language task.
16225194|NCT01198938|Other|Melatonin|Melatonin 5 mg sublingually given at 9 p.m. for 5 postoperative days or until discharge
16225195|NCT01198925|Drug|piperacillin continuous infusion|piperacillin continuous infusion
16225196|NCT01198925|Drug|piperacillin extended infusion|piperacillin extended infusion
16225197|NCT01198912|Drug|placebo|during 56 days
16225198|NCT01198912|Drug|doxycycline 100 mg|during 56 days
16225199|NCT01198899|Other|blood sampling|Blood sampling will be used.
16225200|NCT01198886|Other|Successful Aging Program|Once per week discussion on lifestyle topics important to older adults. Classes conclude with a gentle upper body stretching routine.
16225201|NCT01198886|Other|Exercise-Nutrition Program|Targeted exercise program offered 3-days per week at the study participants place of residence (senior housing facility). Other means to encourage physical activity outside of these exercise classes will be available. A nutrient-rich protein carbohydrate experimental beverage will be taken following the exercise sessions.
16225202|NCT01198873|Drug|Dronedarone|"Film-coated tablet
~Oral administration under fed conditions (during breakfast and dinner)"
16225203|NCT01198873|Drug|Placebo (for Dronedarone)|"film-coated tablet strictly identical in appearance
~Oral administration under fed conditions (during breakfast and dinner)"
16225204|NCT01198860|Drug|CTH Chronic Hepatitis B|"Drug:
~Tenofovir/ 300mg daily
~Phyllanthus Urinaria/300mg daily
~Adenosma Glutinosum/150mg daily
~Eclipta Prostrata/150mg daily
~Ascorbic Acid / 500mg daily"
16225338|NCT01197846|Drug|Placebo|Placebo
16225205|NCT01198847|Behavioral|Dietary, physical activity and sleeping|"The intervention in the present study will be delivered through sessions aiming at developing healthy lifestyle habits regarding physical activity, food intake and regular sleeping habits for parents and children. These sessions will be performed face to face by trained health care workers and carried out in the welfare centres with the parent/s. Children will not be approached directly in the present study. All families will meet with their coach/facilitator during at least 12 times (including start and final evaluation meeting) until the children reach 6 years of age (such as school age). However extra effort (as boosting sessions) will be made if growth records show an increased BMI (weight induced meetings). The parents are also encouraged to keep contact with their coach either by phone or e-mail as often as they feel needed.
~The Low intensity arm will only receive written information and no direct face to face support"
16225206|NCT01198834|Drug|MRX-7EAT|Application of up to two patches at the discretion of the investigator for up to 7 days.
16225207|NCT01198834|Drug|Placebo|Application of up to two patches at the discretion of the investigator for up to 7 days.
16225208|NCT01198834|Drug|Lidocaine|Application of up to two patches at the discretion of the investigator for up to 7 days.
16225209|NCT01198834|Drug|Etodolac|Application of up to two patches at the discretion of the investigator for up to 7 days.
16225210|NCT01198821|Drug|Sodium bicarbonate (g/kg/day)|Dose Escalation - Level 1: 0.3, Level 2: 0.5, Level 3: 0/7, Level 4: 1.0
16225211|NCT01198821|Drug|Gemcitabine (mg/m²)|Dose Escalation - Level 1: 1000, Level 2: 1000, Level 3: 1000, Level 4: 1000
16225212|NCT01198795|Drug|Escitalopram|Patients who meet eligibility criteria will receive open-label escitalopram. 10-20mg oral administration (10mg tablets) once daily for 24-weeks with a 2-week downtaper period.
16225213|NCT01198782|Other|FID 112903 (SYSTANE® ULTRA Lubricant Eye Drops)|Patients will dose 4 times daily for 4 months.
16225214|NCT01198769|Biological|Rotarix TM|Oral, 2 doses
16225215|NCT01198756|Biological|Quadrivalent seasonal influenza vaccine GSK2282512A|For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 17 years of age, single intramuscular dose.
16225216|NCT01198756|Biological|Fluarix™ VB|For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects of 9 to 17 years of age, single intramuscular dose.
16225217|NCT01198756|Biological|Fluarix™ YB|For subject 3 to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects of 9 to 17 years of age, single intramuscular dose
16225218|NCT01198756|Biological|Quadrivalent seasonal influenza vaccine GSK2282512A|Single intramuscular dose for primed subjects, two doses for unprimed subjects.
16225219|NCT01198704|Other|search of factors predicting tumor recurrence|Morphological, chronological, anatomy-pathological and molecular search
16225220|NCT01198691|Device|Insorb absorbable staples|Patients will be randomized to receive either the standard metallic staples or the Insorb absorbable staples
16225221|NCT01198691|Device|Insorb|Patients will be randomized to receive either standard metallic staples or Insorb absorbable staples
16225222|NCT01198678|Dietary Supplement|Boost Nutritional Supplement|Boost- Nutritional Supplement
16225223|NCT01198665|Drug|RAD001 (Everolimus)|Phase I Level 1: RAD001 2.5 mg PO daily D1-14 + CHOP Level 2: RAD001 5 mg PO daily D1-14 + CHOP Level 3: RAD001 7.5 mg PO daily D1-14 + CHOP Level 4: RAD001 10 mg PO daily D1-14 + CHOP CHOP every 3 weeks D1 Cytoxan 750mg/m2 + D5W 100ml MIV over 1hr D1 Doxorubicin 50mg/m2 + D5W 100ml MIV over 30mins D1 Vincristine 1.4mg/m2 (max.2mg) IV push D1-D5 Prednisolone 100mg/d PO (40-30-30) Phase II Determined dosage of RAD001 + CHOP every 3 weeks
16225224|NCT01198639|Device|manual administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform|the anesthesiologists are instructed to maintain the BIS values between 40 and 60 throughout anesthesia using target controlled infusion method
16225225|NCT01198639|Device|closed-loop administration of iv anesthetics (propofol and remifentanil) using the Toolbox platform|an algorithm is used to maintain automatically the BIS values between 40 and 60
16225226|NCT01198626|Drug|JNJ-32729463|150 mg intravenous formulation administered twice daily for at least 72 hours, followed by 250 mg oral formulation administered twice daily for a total treatment time of 7 to 14 days
16225227|NCT01198626|Drug|moxifloxacin|400 mg intravenous formulation administered once daily for at least 72 hours, followed by 400 mg oral formulation administered once daily for a total treatment time of 7 to 14 days. To maintain the blind, subjects will receive one dose of moxifloxacin and one dose of placebo daily.
16225228|NCT01198626|Drug|JNJ-32729463 (Open-Label)|Subjects may receive JNJ-32729463 intravenous formulation up to 150 mg either BID or TID followed by 250 mg oral formulation BID for a total treatment time of 7 to 14 days.
16225229|NCT01198613|Biological|ToleroMune Ragweed|Intradermal injection 1 x8 administrations 2 weeks apart
16225230|NCT01198613|Biological|Placebo|Intradermal injection, 1x8 administrations 2 weeks apart
16225231|NCT01198600|Device|Habitual contact lens|Hydrogel or silicone hydrogel contact lens per participant's habitual brand and prescription
16225232|NCT01198600|Device|Lotrafilcon B contact lens|Commercially marketed silicone hydrogel contact lens
16225233|NCT01198600|Device|Contact lens cleaning and disinfecting system (ClearCare)|Commercially marketed, hydrogen peroxide-based contact lens care system
16225234|NCT01198587|Drug|Zinc Sulfate|"For children ages 6month to 1 year, 12.5mg orally daily for 14 days mixed in 60 mL of fluid.
~For children aged 1 year and above 25mg orally daily for 14 days mixed in 60 mL of fluid."
16225235|NCT01198587|Drug|Placebo oral capsule|Effervescent oral capsules with similar taste to treatment drug Zinc Sulfate is provided to each patient randomized to the placebo arms of the study
16225236|NCT01198574|Dietary Supplement|Iron group|Ferrous fumarate, 60 mg, weekly dose
16225237|NCT01198574|Dietary Supplement|Vitamin A group|Retinol, weekly dose, 15,000 IU
16225238|NCT01198574|Dietary Supplement|Iron and vitamin A group|Ferrous fumarate, Retinol combination group, weekly dose
16225239|NCT01198574|Dietary Supplement|Placebo group|folic acid only as placebo group
16225240|NCT01198561|Device|repetitive Transcranial Magnetic Stimulation|10 times repetitive TMS, high frequency
16225241|NCT01198548|Drug|leucovorin calcium|Given IV
16225242|NCT01198548|Biological|bevacizumab|Given IV
16225243|NCT01198548|Dietary Supplement|cholecalciferol|Given PO
16225244|NCT01198548|Drug|fluorouracil|Given IV
16225251|NCT01198522|Drug|L19IL2 monoclonal antibody-cytokine fusion protein in combination with gemcitabine|"Part A) Patient cohorts will sequentially be assigned to 800 or 1,000 mg/m2 of gemcitabine. gemcitabine will be given in combination with a fixed dose of L19IL2. Part B) Patient cohorts will sequentially be assigned to 10, 15,22.5,30 or 37,5 MioIU IL2 equivalents of L19IL2. L19IL2 will be given in combination with gemcitabine at the dose recommended from Part A. Should the MTD of L19IL2 not be reached within the planned cohorts listed above, the dose of L19IL2 will be further increased following 7.5 MioIU increasing steps.
~Induction treatment: Intravenous (i.v.) infusions of L19IL2 on days 1,3,5,22,24, 26,43,45,47, followed by i.v. infusions of gemcitabine on days 1,8,15,22,29,36,43. Maintenance treatment: Patients with objective tumor responses or stable disease will receive up to 4 cycles of maintenance treatment, starting on day 57: i.v. infusions of L19IL2 on days 1 (day 57), 8,15, followed by an i.v. infusion of gemcitabine. Treatment cycles will be repeated on day 29."
16225252|NCT01198509|Drug|doxycycline|doxycycline - 100 mg twice per day, for 2 months
16225253|NCT01198509|Drug|vancomycin|vancomycin, 250 mg four times a day, for 2 weeks
16225254|NCT01198496|Drug|Losartan, Losartan and HCTZ, Amlodipine , Spironolactone|<Study drugs and treatment steps> Step 1: Losartan 50 mg in principle (other ARB is usable) Step 2: Combination drug containing losartan 50 mg and hydrochlorothiazide 12.5 mg Step 3: Combination drug containing losartan 50mg and HCTZ 12.5mg + amlodipine 5 mg Step 4: Losartan 50 mg + combination drug containing losartan 50 mg and HCTZ 12.5 mg + amlodipine 5 mg Step 5: Losartan 50 mg + combination drug containing losartan 50 mg and HCTZ 12.5 mg + amlodipine 10 mg Step 6: Losartan 50 mg + combination drug containing losartan 50 mg and HCTZ 12.5 mg + amlodipine 10 mg + spironolactone 25 mg
16225255|NCT01198483|Procedure|Combined Micro- Surgery|Microincision Cataract Surgery combined with 23-gauge/25-gauge/27 gauge Vitrectomy
16225256|NCT01198483|Procedure|Combined Small-Surgery|Smallincision cataract surgery combined with 23 gauge vitrectomy
16225257|NCT01198470|Device|TRIUMPH® Lumbar Artificial Disc|The TRIUMPH® Lumbar Artificial Disc is an articulating artificial disc inserted using a posterolateral approach to the lumbar spine.
16225258|NCT01198457|Drug|Clodronate (Bonefos, BAY94-8393)|Random group of patients in oncology clinic
16225259|NCT01198444|Drug|EE/DRSP (Yasmin Product Family)|One tablet per day, orally, 21 tablets followed by 7 days, during three consecutive cycles.
16225260|NCT01198431|Behavioral|Sleep duration|Duration of sleep per night
16225261|NCT01198418|Behavioral|Experimental|Internet-based intervention that assesses transmission risk and provides prevention messages
16225262|NCT01198405|Device|Enhanced external counterpulsation|Treatment of enhanced external counterpulsation (EECP) with a prespecified protocol on top of a guideline-driven standard medical therapy. EECP Protocol is defined as a standard session of a total of 36 hours of EECP treatment, given one hour per day, six days per week. The same session is thereafter repeated at least once every year.
16225263|NCT01198405|Drug|Guideline-driven standard medical therapy|Standard management, both pharmacological and non-pharmacological, given according to current practice guidelines at the discretion of clinicians
16225264|NCT01198392|Drug|s-1 plus cisplatin|S-1:80 mg/m2/day po twice daily on Day 1-21,cisplatin: 20mg/m2 iv on Day 1-4, repeat every 5 weeks. Number of Cycles: until progression or unacceptable toxicity develops.
16225265|NCT01198392|Drug|5-Fu plus cisplatin|"5-Fu 800 mg/m2/d CI 120h ,Cisplatin 20 mg/m2 as a 2 hour i.v. infusion(on day 1 to day 4 )repeat every 4 weeks.
~Number of Cycles: until progression or unacceptable toxicity develops."
16225266|NCT01198379|Drug|aspirin|aspirin 100 mg qd for 3 years
16225267|NCT01198379|Drug|Placebo|
16225268|NCT01198366|Biological|AERAS-402 1.5 x 10^10 vp|
16225269|NCT01198366|Biological|AERAS-402 3.0 x 10^10 vp|
16225270|NCT01198366|Biological|AERAS-402 1.0 x 10^11 vp|
16225271|NCT01198366|Biological|Placebo|
16225272|NCT01198353|Drug|Ziprasidone|100% of the past antipsychotic dose will be maintained in week 1, using flexible dosing of 0-100% during next 3 weeks and then discontinued. Ziprasidone will be maintained with flexible dosing of 40-160mg/day during the study period.
16225273|NCT01198340|Procedure|PC-FNB with basal administration of local anesthetics|Administration of 0.2% ropivacaine for femoral nerve block with 3 ml/h of basal dose, 5ml bolus by the patient, 60 minutes of lock out time.
16225274|NCT01198340|Procedure|PC-FNB without basal local anesthetics|Administration of 0.2% ropivacaine for femoral nerve block without basal dose, with 8 ml bolus by the patient, 60 minutes of lockout time.
16225275|NCT01198327|Drug|ranibizumab|Intravitreal ranibizumab, .5mg dose, PRN but not less than 21 days apart.
16225276|NCT01198327|Other|Peripheral Laser|Areas of nonperfusion identified on wide field angiograms will receive laser, if the patient is continuing to require ranibizumab injections.
16225277|NCT01198314|Procedure|immunosuppression withdrawal|tapering off immunosuppressant
16225278|NCT01198314|Procedure|continue of taking immunosuppressant|maintain immunosuppression
16225279|NCT01198288|Other|domiciliary rehabilitation|a respiratory rehabilitation programme at the patient home
16225280|NCT01198288|Other|Standard Care|As describe in the standard care arm
16225281|NCT01198275|Drug|n-3 PUFAs|1.0 g of EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid) in the average ratio EPA/DHA of 0.19:1.5, one capsule twice a day
16225282|NCT01198275|Drug|Placebo|1.0 g of olive oil,one capsule twice a day
16225283|NCT01198275|Drug|RASS inhibitors and/or RAS blockers|Patients on ACE-Is or ARBs were continued on the same agent. In those who were not on therapy, an ACE-I or an ARB was started. In all patients, an effort was made to achieve the highest tolerated dose.
16225284|NCT01198275|Drug|Amiodarone|Patients on amiodarone were continued at a maintenance dose of 200 mg daily, whereas those who were not taking amiodarone were started at a dose of 400 mg daily for 1 week and then continued on a maintenance dose of 200 mg daily.
16225285|NCT01198249|Drug|multiple dose, crossover study between single and concomitant administrations of amlodipine, losartan, and hydrochlorothiazide|amlodipine 10 mg for 9 days , losartan 100 mg for 9 days, hydrochlorothiazide (HCTZ) 25 mg for 9 days and combination of amlodipine 10 mg, losartan 100 mg and hydrochlorothiazide (HCTZ) 25 mg for 9 days, 4 way crossover study
16225339|NCT01197833|Drug|endovenous ablation+polidocanol injectable microfoam 0.125%|All components except API
16225340|NCT01197833|Drug|Endovenous ablation+polidocanol injectable microfoam 1.0%|endovenous ablation to target vein, followed by injection of polidocanol injectable foam 1.0%
16225286|NCT01198236|Drug|Itraconazole|"Itraconazole will be administered intravenously 2×200 mg/d(200mg twice a day, with 12 hours interval, and should be completed in no less than 60 minutes each time) in the first two days of treatment as a loading dose, then 200mg/d intravenously (200mg once a day with 24 hours interval and completed in no less than 60 minutes) until the end of the at-risk period.
~In transplant patients, the end of at-risk period is defined as a stable engraftment of 1*109/L neutrophil cells; in patients who have undergone chemotherapy, it is defined as the resolution of neutropenia (neutrophil cells> 0.5*109/L).
~If needed, the patients will take itraconazole solution orally after intravenous administration."
16225287|NCT01198223|Drug|garlic , nystatin|mouthwash
16225288|NCT01198210|Drug|saline|local peritonsillar infiltration of 2 ml saline,
16225289|NCT01198210|Drug|Ketamine|local peritonsillar infiltration of ketamine (0.5 mg/kg)
16225290|NCT01198210|Drug|Dexamethasone|local peritonsillar infiltration dexamethasone (0.2 mg/kg))
16225291|NCT01198210|Drug|ketamine-dexamethasone|local peritonsillar infiltration combination of ketamine0.5mg/kg-dexamethason 0.2mg/kg
16225292|NCT01198197|Drug|NOP-1A|
16225293|NCT01198184|Drug|temsirolimus|Given IV or PO
16225294|NCT01198184|Drug|gamma-secretase/Notch signalling pathway inhibitor RO4929097|Given PO
16225295|NCT01198184|Other|laboratory biomarker analysis|Correlative studies
16225296|NCT01198184|Other|pharmacological study|Correlative studies
16225297|NCT01198171|Other|Laboratory Biomarker Analysis|Correlative studies
16225298|NCT01198171|Other|Study of Socioeconomic and Demographic Variables|
16225299|NCT01198158|Biological|Bevacizumab|Given IV
16225300|NCT01198158|Drug|Everolimus|Given PO
16225301|NCT01198158|Other|Laboratory Biomarker Analysis|Correlative studies
16225302|NCT01198158|Other|Pharmacological Study|Correlative studies
16225303|NCT01198145|Drug|sulfasalazine|Given orally
16225304|NCT01198145|Other|placebo|Given orally
16225305|NCT01198132|Dietary Supplement|Cholecalciferol (Vitamin D3)|Subjects receive Cholecalciferol 100,000 IU one dose fortnightly (equivalent to a daily dose of approximately 7142 IU) for 96 weeks treatment period along with subcutaneous Rebif 44 mcg 3 times a week.
16225306|NCT01198132|Dietary Supplement|Placebo|Subjects receive matching placebo to Cholecalciferol once every two weeks orally along with subcutaneous injection of Rebif 44 mcg 3 times weekly.
16225307|NCT01198132|Drug|Rebif|Subjects receive subcutaneous injection of Rebif 44 mcg 3 times weekly.
16225308|NCT01198119|Device|Location of the suspected lesions|"The suspected lesions will be located before the excision, during the surgery.
~With traditional light
~NBI technique The images will be recorded and compared"
16225309|NCT01198119|Procedure|Biopsy|In case of suspected lesions detected by the NBI technique, this area is biopsied
16225310|NCT01198119|Procedure|Lesion excision/Surgery|In case of positive biopsy, the suspected lesions is excised
16225311|NCT01198106|Drug|scopolamine|0.6 mg
16225312|NCT01198106|Drug|cinnarizine|50 mg
16225313|NCT01198080|Biological|CD133+ cells|bone marrow derived CD133+ cells injection with core compression
16225314|NCT01198067|Drug|Pomalidomide|Given PO
16225315|NCT01198054|Drug|Lenalidomide|"Initial dose of oral lenalidomide is 10 mg/day for 28 days every 28 days, during 6 months.
~In case of response on day 169, patient will follow a treatment extension phase. The dose of lenalidomide should be the same as the last dose for initial phase, until 24 months or progression disease"
16225316|NCT01198028|Drug|Erlotinib|Given PO
16225317|NCT01198002|Drug|LY2127399|Administered Subcutaneously (SC)
16225318|NCT01198002|Drug|Placebo Q2W|Administered SC
16225319|NCT01198002|Drug|Placebo Q4W|Administered SC
16225320|NCT01198002|Drug|Methotrexate|Methotrexate is a background therapy.
16225321|NCT01197989|Device|TEPSO cloth|TEPSO stocks should be worn continuously for 4 weeks of the study and will be changed every 3 days without wearing again those already used (even after washing).
16225322|NCT01197989|Device|Standard cloth|Standard cotton stocks should be worn continuously for 4 weeks of the study and will be changed every 3 days without wearing again those already used (even after washing).
16225323|NCT01197976|Device|TEPSO cloth|TEPSO stocks should be worn continuously for 4 weeks of the study and will be changed every 3 days without wearing again those already used (even after washing).
16225324|NCT01197976|Device|Standard cloth|Standard cotton stocks should be worn continuously for 4 weeks of the study and will be changed every 3 days without wearing again those already used (even after washing).
16225325|NCT01197963|Procedure|Sleeve Gastrectomy and Ileal transposition|Laparoscopic sleeve gastrectomy with ileal transposition
16225326|NCT01197963|Dietary Supplement|dietary and medical management|dietary and medical routine management patients are currently following with an endocrinologist.
16225327|NCT01197950|Device|Manual Acupuncture|The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour.
16225328|NCT01197950|Device|Electro Acupuncture|The women will receive treatment on bilateral points, both distal points and local points and the needles will be manually stimulated to reach De Qi every ten minutes during one hour. Eight needles in the painful area (local points) will be connected to an electro-stimulator and stimulated with high frequency (80 Hz) square wave pulses (0.18-ms duration) with alternating polarity. The woman will adjust the intensity of the electrical stimulation to be just under pain threshold.
16225329|NCT01197924|Other|IRMf Bold|IRMf BOLD of the working memory
16225330|NCT01197911|Drug|aleglitazar|single oral dose
16225331|NCT01197898|Biological|Collagenase Santyl Ointment|Topical daily application
16225332|NCT01197898|Other|Placebo Comparator|Topical daily application
16225333|NCT01197885|Drug|IMAB362|Cohort 1 repeated doses of 300 mg/m2 Cohort 2 repeated doses of 600 mg/m2 Cohort 3 doses to be determined, 600mg/m2 or less
16225334|NCT01197872|Other|Preimplantation Genetic Diagnosis|Genetic testing on embryos to identify embryos that are affected by a single gene disorder (e.g. cystic fibrosis, Tay-Sachs, sickle cell anemia).
16225335|NCT01197859|Device|Definitive Contact Lens|Daily wear contact lens
16225336|NCT01197859|Device|Biofinity|Daily wear contact lens
16225337|NCT01197846|Drug|Quetiapine|quetiapine 300 mg or 600 mg
16225341|NCT01197833|Drug|Endovenous ablation+polidocanol injectable foam 2.0%|Endovenous ablation to target vein followed by injection of polidocanol injectable foam 2.0%
16225342|NCT01197820|Device|MRI|"Patients will have a regular hepatic or kidney MRI investigation; we will add our sequences on their initial protocol. At first, one thermometry sequence is performed before angular correction is achieved with the following parameters: FOV=300 mm, matrix=96*96, TE/TR=18/72 ms, 67 lines/TR, Sense factor=1.4, 5 slices (4 coronal et 1 sagittal), 30° Flip angle.
~In order to determine the main direction of motion, a set of 200 images are acquired during motion with two interleaved orthogonal slices (one coronal and one sagittal) centered on the region of interest, with the read out direction aligned with the head-feet direction. True-fisp images are acquired during 40 seconds with the following parameters: FOV=400 mm, matrix=128*109, TE/TR=1.2/2.43 ms, 60° flip angle, and 6 mm slice thickness.
~Then the tested software proposes an angular correction to minimize out of plane motion. For each set of orientations, MR thermometry is performed"
16225343|NCT01197807|Procedure|Bulb Suctioning|Bulb suctioning of the mouth then the nose immediately following delivery
16225344|NCT01197807|Procedure|Wiping|Gentle wiping of mouth then nose with a soft cloth immediately following delivery
16225345|NCT01197794|Drug|AZD1981|AZD1981 twice daily
16225346|NCT01197794|Drug|AZD1981|AZD1981 once daily
16225347|NCT01197794|Drug|Placebo|Placebo to match AZD1981
16225348|NCT01197781|Drug|FOSTAMATIN|Oral tablets - single dose
16225349|NCT01197781|Drug|Verapamil|Oral tablets - administered 3 times daily over 4 days
16225350|NCT01197768|Behavioral|Nutrition Intervention|Participants randomized to the intervention group receive a comprehensive nutrition assessment and a in-home intervention with follow-up calls from a Registered Dietician who will addresses their risk for becoming under-nourished at multiple levels.
16225351|NCT01197755|Drug|fostamatinib|fostamatinib 100 mg twice daily
16225352|NCT01197755|Drug|fostamatinib|fostamatinib 100 mg twice daily/150 mg once daily
16225353|NCT01197755|Drug|placebo|Placebo twice daily
16225354|NCT01197664|Drug|paricalcitol|Given PO
16225355|NCT01197664|Radiation|radiation therapy|Undergo radiotherapy
16225356|NCT01197664|Other|laboratory biomarker analysis|Correlative studies
16225357|NCT01197664|Drug|fluorouracil|Given PO
16225358|NCT01197625|Biological|Dendritic cell vaccine|Autologous Dendritic Cells Loaded With mRNA From Primary Prostate Cancer Tissue, hTERT and Survivin
16225359|NCT01197612|Drug|pulmicort|applied to nasal packing after surgery
16225360|NCT01197573|Drug|rTPA Treatment|Ex-vivo treatment of DCD liver or kidney with rTPA (recombinant tissue plasminogen activator)prior to implantation
16225361|NCT01197573|Other|No TPA Treatment|Standard of Care
16225362|NCT01197560|Drug|Lenalidomide|Lenalidomide 25 mg orally for 21/28 days until Diffuse Large B-Cell Lymphoma (DLBCL) progressive disease. For patients with Creatinine Clearance ≥ 30 mL/min but < 60 mL/min, lenalidomide 10 mg (max escalation is 15 mg).
16225363|NCT01197560|Drug|Gemcitabine|Suggested starting doses and regimens for Gemcitabine is 1,250 mg/m^2 intravenous (IV) administration on days 1, 8, 15 every 28 days for 6 Cycles or 1,000 mg/m^2 IV days 1 and 15 every 28 days for 6 Cycles
16225364|NCT01197560|Drug|Oxaliplatin|Suggested starting dose and regimen for Oxaliplatin is 100 mg/m^2 IV day 1 for 21 days for 6 Cycles
16225365|NCT01197560|Drug|Rituximab|Suggested starting dose for Rituximab is 375 mg/m^2 IV days 1, 8, 15, 22 during Cycle 1, and if stable disease at Week 12, also on Day 1 of Cycles 4, 6, 8, and 10 (CD20+ patients only)
16225366|NCT01197560|Drug|Etoposide|"Suggested starting doses for Etoposide are:
~100 mg/m^2 IV days 1-5 every 28 days for 6 Cycles, or 100 mg/m^2 IV days 1-3 every 28 days for 6 Cycles, or 50 mg/m^2 oral days 1-21 every 28 days for 6 Cycles, or 50 mg/m^2 oral days 1-14 every 28 days for 6 Cycles, or 50 mg/m^2 oral days 1-10 every 28 days for 6 Cycles"
16225367|NCT01197547|Device|Genesys HTA|Genesys HTA Endometrial Ablation
16225368|NCT01197534|Drug|fostamatinib|fostamatinib 100 mg twice daily
16225369|NCT01197534|Drug|fostamatinib|fostamatinib 100 mg twice daily/ 150 mg once daily
16225370|NCT01197534|Drug|placebo, fostamatinib|Placebo for 24 weeks followed by fostamatinib 100 mg twice daily.
16225371|NCT01197521|Drug|fostamatinib|fostamatinib 100 mg twice daily
16225372|NCT01197521|Drug|fostamatinib|fostamatinib 100 mg twice daily/150 mg once daily
16225373|NCT01197521|Drug|placebo, fostamatinib|Placebo for 24 weeks followed by fostamatinib 100 mg twice daily
16225374|NCT01197508|Drug|TC-5214|Twice daily for 8 weeks.
16225375|NCT01197508|Drug|Placebo|Twice daily for 8 weeks.
16225376|NCT01197495|Device|hyaluronic acid gel|Dosage per Investigator's discretion to obtain lip treatment gel; 1 touch-up treatment is allowed 14 to 30 days after initial treatment. Repeat treatment occurs at month 12. Subjects in the control group start with treatment at month 3. Maximum total volume per subject is 4.8 mL for initial and touch-up treatment combined.
16225377|NCT01197469|Drug|Tadalafil|Tadalafil 10mg once daily for 3 months
16225378|NCT01197469|Drug|Placebo|
16225379|NCT01197443|Behavioral|Parent-only Group|Parent-only group will include the same skills and techniques to promote weight loss as given to the parent + child group, but the information will be delivered only to the parent. Parent group will be compared to the parent group of the parent + child treatment arm. The focus will be on implementing skills learned to assist the child in weight management. The treatment length is set for 12 weekly meetings and bi-monthly meetings during months 4 and 5. Each group session will be 60-min including weigh-ins. Group meetings focus on behavior change, weight loss, healthy eating and activity for the overweight child and parent.
16225380|NCT01197443|Behavioral|Parent + Child Group|The treatment for participants in the parent + child group will be administered in two separate groups, one for the parents and one for the child. Treatment will include the same skills and techniques to promote weight loss as given to the parent-only group, but the information will be delivered to both the parent and child. The treatment length, session schedule, treatment content and follow-up assessments are same as the parent-only group.
16225381|NCT01197430|Other|exercise training|
16225382|NCT01197417|Drug|Intravenous Magnesium Sulfate|40 mg/kg (max 2.4 grams), infused at a concentration of 40 mg/ml (1 ml/kg, max 60 ml), every 8 hours for a total of 6 doses
16225383|NCT01197417|Drug|Normal Saline Placebo|(1 ml/kg, max 60 ml), administered every 8 hours for a total of 6 doses
16225601|NCT01195779|Biological|Fluarix™|Intramuscular injections
16225384|NCT01197404|Behavioral|Affect Management|12-session group intervention including affect management training as well as sexual health skills training.
16225385|NCT01197404|Behavioral|General Health Promotion|12-session group intervention including health information on a variety of developmentally relevant health topics.
16225386|NCT01197391|Biological|REGN728|2 Subcutaneous Cohorts (dose 1, 2)
16225387|NCT01197378|Drug|Cysteamine Bitartrate Delayed-release Capsules|"Participants who entered the trial from the RP103-03 study continued treatment with cysteamine bitartrate every 12 hours at the last dose level prescribed during their participation in that study.
~Participants not entering the trial from Study RP103-03 were started on twice a day administration of cysteamine bitartrate at a total daily RP103 dose of 70% of their pre-study total daily stable Cystagon® dose."
16225388|NCT01197365|Other|Infant formula with GOS, beta-palmitate, acidified milk|"Infant formula supplemented with functional ingredients (galacto-oligosaccharides, beta-palmitate, acidified milk.
~Infant formula with functional ingredients is in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae"
16225389|NCT01197365|Other|Standard infant formula without functional ingredients|Standard infant formula, in compliance with Directive 2006/141/CE on infant formulae and follow-on formulae, without functional ingredients
16225390|NCT01197352|Behavioral|Motivational and Normative Feedback|Weekly feedback based on their frequency and degree of at-risk drinking behavior using normative, educational and motivational feedback
16225391|NCT01197352|Behavioral|Self-Awareness|Weekly queries to raise awareness and allow self-reflection about drinking habits
16225392|NCT01197339|Behavioral|resonant voice|A 4-hr resonant voice exercise will be prescribed to subjects following vocal loading.
16225393|NCT01197339|Behavioral|voice rest|A 4-hr voice rest will be prescribed to subjects following vocal loading.
16225394|NCT01197339|Behavioral|Breathy voice|A 4-hr breathy voice exercise will be prescribed to subjects following vocal loading.
16225395|NCT01197339|Behavioral|Relaxation exercise|A 4-hr relaxation exercise will be prescribed to subjects following vocal loading.
16225396|NCT01197339|Behavioral|Resonant voice and relaxation exercise|A 4-hr resonant voice and relaxation exercise will be prescribed to subjects following vocal loading.
16225397|NCT01197326|Device|use of the MP5 EWS patient monitor|All patients on the study ward receive the same care in Groups 1 and 2. The only difference is the device used to collect the vital signs. In Group 2, the MP5 EWS spot check monitor (FDA approved and CE marked) is the vital signs collection device.
16225398|NCT01197313|Other|Home-based exercise|
16225399|NCT01197300|Drug|Zoledronic acid|intravenous infusion
16225400|NCT01197287|Drug|QAK423A|
16225401|NCT01197287|Drug|QAK423A|
16225402|NCT01197287|Drug|QAK423A|
16225403|NCT01197274|Device|Simple blood lancet|Skin prick testing with blood lancet and DuoTip is performed on the back of mite-sensitized person. Allergen(Der p)is placed in 1st and 2nd row whereas histamine is placed in 3rd row. Allergen and normal saline are placed alternately in 4th row. Block randomization were allocated subjects into 2 groups; Group1:blood lancet is performed in 1st row and DuoTip in 2nd row. Group2:DuoTip is performed in 1st row and blood lancet in 2nd row. Blood lancet is applied in 3rd and 4th row in all subjects. A technician performed device applications and another technician who is blinded to device performed all readings. Pain was assessed on a scale from 0 to 10 with 0 being no pain and 10 being the worst imaginable pain
16225404|NCT01197261|Drug|Oxycodone naloxone prolonged release tablets|2 tablets/ day
16225405|NCT01197261|Drug|Placebo tablets|2 tablets/ day
16225406|NCT01197248|Procedure|Cystocele plication|placement of sutures over the pubocervical fascia during the cystocele repair
16225407|NCT01197248|Procedure|No Plication|Avoid sutures over pubocervical fascia during cystocele plication
16225408|NCT01197235|Drug|darbepoetin-α|Infusion of darbepoetin-α 1.5 μg/kg will be performed 1 hour before angiography
16225409|NCT01197235|Drug|isotonic saline|Infusion of isotonic saline will be performed 1 hour before angiography
16225410|NCT01197222|Device|EndoClear Lens Cleaning Device|EndoClear Lens Cleaning Device is used during a laparoscopic abdominal surgery.
16225411|NCT01197209|Biological|Ad-REIC/Dkk-3|REIC (Reduced Expression in Immortalized Cells) protein is down regulated in a variety of cancer cell lines including prostate tumors. The REIC gene is identical to the Dickkopf-3 (Dkk-3) gene that is a member of the Dickkopf gene family. Ad-REIC/Dkk-3 is designed as a viral vector that delivers a DNA plasmid capable of producing intracellular REIC protein. The expression plasmid includes the full-length human cDNA sequence for REIC. The adenovirus vector is a transport mechanism to infuse the REIC/Dkk-3 plasmid into the cell providing a temporary transfusion of REIC protein.
16225412|NCT01197196|Behavioral|Behavioral Weight Loss Intervention|Participants assigned to this condition will receive an intensive group-based lifestyle program modeled after the DPP and Look AHEAD trials. Participants will attend 16 weekly sessions involving provision of behavioral goals and strategies to modify diet and exercise behaviors in order to achieve a weight loss of at least 7% of initial body weight.
16225413|NCT01197196|Other|Migraine Education|Participants assigned to this condition (Healthy Living for Migraine Relief [HLMR]) will receive basic education and didactic instruction in migraine headaches and treatments that are the standard of care. Participants will attend 4 months of weekly group lectures focused on 3 different major topic areas: 1) migraine symptomatology and pathophysiology, 2) standard abortive and preventive pharmacological treatment options, and 3) standard and alternative non-pharmacological treatment options.
16225414|NCT01197170|Drug|Anastrozole|1 mg by mouth daily of a 28 day cycle.
16225415|NCT01197170|Drug|Bevacizumab|Starting dose 10 mg by vein on day 1 of a 21 day cycle.
16225416|NCT01197170|Drug|Everolimus|Starting dose 5 mg by mouth daily for a 28 day cycle.
16225417|NCT01197170|Drug|Sorafenib|Starting dose 200 mg by mouth twice a day of a 28 day cycle.
16225418|NCT01197170|Drug|Erlotinib|Starting dose 75 mg by mouth daily for a 28 day cycle.
16225419|NCT01197157|Drug|Placebo|Group A: comprises 100 CHC patients who will receive placebo twice daily with food for an average of 12 weeks as a part of monotherapy lead-in phase followed by triple therapy, nitazoxanide 500 mg twice daily plus peginterferon alfa-2a (once weekly), and weight-based ribavirin (1000-1200 mg daily) for 48 weeks.
16225550|NCT01196234|Drug|Paclitaxel/Carboplatin|paclitaxel (175mg/m2 on day 1)/carboplatin (AUC 5 on day 1)
16225551|NCT01196208|Drug|brentuximab vedotin|Every 21 days by intravenous infusion (1.8 mg/kg)
16225420|NCT01197157|Drug|Nitazoxanide|• Group B: comprises 100 chronic hepatitis patients who will receive oral Nitazoxanide 500 mg twice daily with food for an average of 12 weeks followed by the standard of care treatment, peginterferon Alfa 2a once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses plus placebo twice daily for 48 weeks.
16225421|NCT01197144|Drug|adalimumab|Subcutaneous, 40 mg every other week for 4 weeks
16225422|NCT01197144|Drug|Placebo|Subcutaneous, every other week for 4 weeks
16225423|NCT01197118|Radiation|sequence chemoradiotherapy|"Postoperative radiotherapy regimen: Therapy plan system was formulated by Computed tomographic (CT) simulation. Radiation was delivered with 15MV photons. Radiotherapy consisted of 4500 cGy of radiation at 180 cGy per day, five days per week for five weeks, to the tumor bed, to the margins of resection or the stoma, to the regional nodes. Protection of spinal cord, heart, liver and kidney should be considered.
~Postoperative chemotherapy regimen: see arm 2"
16225424|NCT01197118|Drug|chemotherapy alone following radical resection|Postoperative chemotherapy regimen: The OLF regimen was administrated: Oxaliplatin, 130 mg/m2/day on day1, i.v. 2 h; fluorouracil, 425 mg/m2/day on day1~5, i.v.; leucovorin, 200 mg/m2/day on day 1~5, i.v.; every 21 days repeated, for 6 cycles.
16225425|NCT01197105|Biological|Use of natural product (Schinus terebinthifolius)|Mouthwash (0,3125% of schinus terebinthifolius) 10mL per day during 14 days.
16225426|NCT01197092|Dietary Supplement|Mitochondrial preparations|"Oral therapy with mitochondrial preparations based on recipes of Dr Kremer and the Tisso company:
~ProEMSan (large intestinal symbionts with 31 strains of bacteria) Pro Basan (small intestinal symbionts) ProSirtusan (Polyphenol-mix and vitamins) ProVita D3 (Vitamin D3 supplement) ProOmega (Omega 3-fatty acid preparation) ProCarnitin (Carnitine-preparation) ProSango Vital (trace element preparation)"
16225427|NCT01197092|Dietary Supplement|Infusion therapy|Infusion therapy in the form of a complex mix: 500ml-solution with trace elements, amino acids and antioxidants.
16225428|NCT01197092|Device|Webermedical device|Intravenous-Blood-Laser-Therapy: the Webermedical device will be used
16225429|NCT01197092|Behavioral|Nutritional therapy|"Nutritional therapy based on IgG-blood results. Significant antibody-formation against foodstuffs will be ascertained (in foodstuffs evaluated through the BioMedicalScreen), will be taken out of the diet - the background being the additional lowering of risk potential of those antibodies causing the so called silent inflammation (sub-clinical inflammation) -ultimately an anti-inflammatory diet will be given in the protocol. The following have special focus: gluten, cow's milk, fish, meat, nuts."
16225430|NCT01197079|Other|Survey|Self administered anonymous survey
16225431|NCT01197066|Drug|Certolizumab Pegol|Certolizumab Pegol 200mg
16225432|NCT01197053|Biological|Epicutaneous Immunotherapy|100 mcg peanut proteins (active arm) applied on the skin every 24 hrs for 6 months blinded, followed by 12 months open treatment for all patients in the active arm
16225433|NCT01197053|Biological|placebo of peanut|placebo applied on the skin every 24 hrs for 6 months blinded, followed by 12 months open treatment for all patients in the active arm
16225434|NCT01197040|Drug|Prednisone|1 mg/kg/day for 4 weeks. Then, the dose will be progressively tapered if the remission will be achieved. For patients who exhibit incomplete remission at this time, high dose steroid will be continued for 4 weeks again before the tapering.
16225435|NCT01197040|Drug|acid mycophenolic (Myfortic)|patients will receive prednisone 0.5 mg/kg/day combined with mycophenolic acid (MyforticR) 1440 mg/day. The management of steroid therapy will be identical in both groups, while MyforticR will be continued for six months
16225436|NCT01197027|Behavioral|Standard counseling|Standard HIV counseling
16225437|NCT01197014|Drug|Amlodipine plus Losartan|Amlodipine/Losartan high dose
16225438|NCT01197014|Drug|Amlodipine, Losartan|Amlodipine, Losartan
16225439|NCT01197001|Drug|Amlodipine plus Losartan|Amlodipine/Losartan low dose
16225440|NCT01197001|Drug|Amlodipine, Losartan|Amlodipine, Losartan
16225441|NCT01196988|Biological|Influenza vaccine GSK2321138A|intramuscular injections
16225442|NCT01196988|Biological|FluarixTM|intramuscular injections
16225443|NCT01196988|Biological|Influenza vaccine GSK2604409A|intramuscular injections
16225444|NCT01196975|Biological|Quadrivalent seasonal influenza vaccine GSK2282512A|Single intramuscular dose
16225445|NCT01196975|Biological|FluLavalTM-VB|Single intramuscular dose
16225446|NCT01196975|Biological|FluLavalTM-YB|Single intramuscular dose
16225447|NCT01196962|Device|Central venous catheter|Central venous catheter insertion to subclavian vein
16225448|NCT01196949|Other|Manipulative and Rehabilitative Therapy|Participants will receive 6 treatments over a 3 to 5 week time frame. A minimum of one day and maximum of 3 days between treatments. This group will receive high velocity low amplitude thrust to a minimum of 1 and maximum of 3 restricted segments within the mortise joint, subtalar joint and tarsal along with the same rehabilitation protocol as the other group.
16225449|NCT01196949|Other|Rehabilitative Therapy|Participants will receive education and training in the home exercises. This group is only required to attend the treatment facility for outcome measure readings and if they have any questions about the research protocol or check if they are performing their exercises correctly. A Theraband will be utilized for the peroneal muscle strengthening; 3 sets of 12 repetitions. Proprioception will be conducted on a Bosu Ball; 10 minutes per period. This protocol will be conducted everyday at home for the 5 week study. A diary will be required to record compliance and indicate how exercises should be performed.
16225450|NCT01196936|Drug|Tamoxifen Citrate|5 mg PO Daily
16225451|NCT01196936|Drug|Placebo|1 tablet daily
16225452|NCT01196936|Procedure|Digital mammography|Correlative studies
16225453|NCT01196936|Other|immunohistochemistry staining method|Correlative Studies
16225454|NCT01196936|Other|pharmacological study|Correlative Studies
16225455|NCT01196936|Other|laboratory biomarker analysis|Correlative Studies
16225456|NCT01196936|Genetic|protein expression analysis|correlative studies
16225457|NCT01196936|Other|pharmacogenomic studies|correlative studies
16225458|NCT01196936|Other|questionnaire administration|Ancillary studies
16225459|NCT01196936|Procedure|Fine needle aspiration|
16225460|NCT01196936|Other|Quality of Life Assessment|Ancillary Studies
16225461|NCT01196923|Device|Endoscopically Guided Ablation|Visually Guided Ablation using EAS-AC
16225462|NCT01196910|Device|treatment by HLPFC coil|"DTMS treatment will be given for 3 weeks, 5 days a week. Before each DTMS treatment, neural network excitation practice will be done using AttenGo software (AttenGo, Herzlia, Israel).
~Each treatment day: Follow-up to evaluate clinical side effects of treatment. Two additional meetings with DTMS treatment and follow-up will be held to evaluate the efficacy of treatment and side effects. The first will be four weeks after the end of the daily treatment phase; the second eight weeks after the end of the daily treatment phase."
16225463|NCT01196897|Device|WATCHMAN LAA Closure Technology (Gen 4.0)|Implantation of the WATCHMAN device into the left atrial appendage.
16225464|NCT01196871|Drug|Migalastat HCl|Oral capsules, single dose
16225465|NCT01196871|Biological|Agalsidase Beta|IV infusion, single dose
16225466|NCT01196871|Biological|Agalsidase Alfa|IV infusion, single dose
16225467|NCT01196845|Device|cPAP|Patients are randomised in 2 arms : cPAP or sham cPAP
16225468|NCT01196845|Device|cPAP|Patients are randomised in 2 arms : cPAP or Sham cPAP
16225469|NCT01196845|Device|cPAP|Patients are randomised in 2 arms : cPAP or sham cPAP
16225470|NCT01196845|Device|cPAP|Patients are randomised in 2 arms : cPAP or sham cPAP
16225471|NCT01196832|Procedure|blood sample|blood sample for fibrocytes analysis
16225472|NCT01196832|Procedure|Clinical and functional evaluation|Plethysmography, Carbon monoxide capacity of transfer , arterial gaz
16225473|NCT01196819|Device|Firehawk|Implantation of Firehawk drug eluting stent
16225474|NCT01196819|Device|Xience V|Implantation of Xience V drug eluting stent
16225475|NCT01196767|Drug|Ropivacaine (in one arm); catheterization (in both).|"Parallel study with two groups:
~ropivacaine (2 mg.mL-1), at the rate of 4 mL.hr-1 through two subcutaneous catheters lateral to the sternum, both alimented by an elastomeric pump.
~same protocol, with normal saline instead of ropivacaine."
16225476|NCT01196754|Other|sevoflurane|
16225477|NCT01196741|Drug|Paclitaxel|Paclitaxel 80 mg/m2 weekly for 6 weeks followed by a 2 week break (1 cycle), for 4 cycles initially (32 weeks). If there is evidence of on-going response after 4 cycles, 3 further cycles will be given, unless there is dose-limiting toxicity or the patient requests to discontinue treatment. If best response is stable disease after 4 cycles, treatment should be discontinued but may continue at the discretion of the Investigator.
16225478|NCT01196741|Drug|Saracatinib|Saracatinib 175 mg PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression
16225479|NCT01196741|Drug|Matched placebo|Matched placebo PO once daily, to begin 1 week prior to commencement of chemotherapy, taken continuously until progression
16225480|NCT01196728|Drug|CM3.1-AC100|SAD study with single ascending subcutaneous doses
16225481|NCT01196715|Drug|Darbepoetin alpha|Aranesp 500 mcg vials once every 2 weeks.
16225482|NCT01196715|Drug|Filgrastim|300 mcg vials twice a week, 3-4 days apart
16225483|NCT01196715|Procedure|Blood Red Cell Transfusion|Red cell transfusion support to achieve a predicted post-transfusion haemoglobin of 11.0 to 12.0 g/dl at a quantity and frequency such that the minimum haemoglobin is never below 8.0 g/dl or such that the patient is never excessively symptomatic, according to local transfusion guidelines/policy.
16225484|NCT01196689|Drug|AZD1981 100 mg twice daily for 61/2 days|100 mg tablets
16225485|NCT01196676|Drug|AZD4451|1 mg capsules, 5 mg capsules, and 25 mg capsules
16225486|NCT01196676|Drug|Placebo|1 mg capsules, 5 mg capsules, and 25 mg capsules
16225487|NCT01196663|Device|Intraoperative temperature measurement by TMS thermometer|Measurements will be taken from the patient's body using a biocompatible patch that will transfer data to the receiving unit. The patch will be sterilized before each surgery.
16225488|NCT01196663|Device|Esophageal or urinary bladder temperature measurement|Standard temperature measurement as is being measured from patients during surgery today
16225489|NCT01196650|Drug|IN 10 003 formulation A|
16225490|NCT01196650|Drug|IN 10 003 formulation B|
16225491|NCT01196650|Drug|Placebo capsules|
16225492|NCT01196624|Device|rapid TMS, EXPOSURE TO TRAUMATIC STIMULI|RAPID TMS, EXPOSURE TO TRAUMATIC STIMULI
16225493|NCT01196624|Device|rapid TMS, EXPOSURE|apid TMS, EXPOSURE
16225494|NCT01196611|Behavioral|Voice Amplification|Behavioral: Voice Amplification. Patients use VA over a course of 6 weeks Control group. No treatment over a course of 6 weeks.
16225495|NCT01196611|Behavioral|Function Voice Exercises|Function Voice Exercises Patients will receive 6 sessions of therapy over a course of 6 weeks, with one session per week.
16225496|NCT01196598|Other|Exercises|"Three individual initial sessions for learn about pelvic floor muscle localization and function; receive lifestyle advice and practice the exercises correctly.
~The control group receive only lifestyle advice.
~Followed by three months of home training with appointments each two weeks with physiotherapist."
16225497|NCT01196585|Procedure|CT-Guided pleural needle biopsy with Abrams' needle|Patients will be randomized into two groups: Group A: CT-guided Abrams' needle biopsy.
16225498|NCT01196585|Procedure|Ultrasonography guided cutting pleural needle biopsy|Patients will be randomized into two groups: Group B: Ultrasonography guided cutting-needle biopsy.
16225499|NCT01196572|Procedure|Internal Urethrotomy|surgical incision of urethral stricture using endoscopic cold knife vs. endoscopic laser
16225500|NCT01196559|Drug|Vinorelbine and Gemcitabine|Gmcitabine 1000㎎/㎡ mix in normal saline 100ml iv for 30min andVinorelbine 25㎎/㎡ mix in normal saline 50 ml iv for 5-10min on D1 and 8 every 21 days cycle
16225501|NCT01196546|Drug|vildagliptin/metformin|
16225502|NCT01196533|Device|Non invasive peripheral blood monitoring|non invasive monitoring
16225503|NCT01196507|Drug|Carvedilol|Carvedilol will be administered orally at a start dose of 3.125 mg twice daily. After 1 week, this will increased if systolic blood pressure does not fall below 90 mm Hg. The patient will receive the maximum tolerated dose of carvedilol or with a maximum of 12.5 BD.
16225504|NCT01196507|Drug|Placebo|The placebo tablets will be identical to the carvedilol tablets. First the patients will receive placebo in the dose of 1 BD. Then depending on his tolerance it will be increased to a maximum of 4 BD.
16225505|NCT01196494|Procedure|intraoperative colon lavage with primary anastomosis|Patients with obstructive left-sided colonic cancer in wich treatment in one stage procedure is intraoperative colon lavage with primary anastomosis to avoid Hartamnn´s Procedure
16225506|NCT01196481|Drug|Carvedilol+VSL#3|Tablet Carvedilol 6.25 mg BD & capsule VSL#3 1 TDS for 2 year
16225507|NCT01196481|Procedure|Endoscopic variceal ligation|In the Endoscopic Variceal Ligation arm, Endoscopic Variceal Ligation will be performed using multibander devices by senior fully trained endoscopists or under their direct supervision. Varices will be banded starting at the gastroesophageal junction moving proximally upward in a spiral fashion. Patients will undergo Endoscopic Variceal Ligation every 3-4 weeks until eradication. Eradication is defined as the absence of varices or presence of grade I esophageal varices. Following eradication, the interval for the next endoscopy will be every 3 months to look for recurrence of varices. Endoscopic Variceal Ligation sessions would be repeated for the recurrent varices if they are sufficiently large.
16225508|NCT01196468|Other|HIV test (serological or salivary)|"An HIV test will be offered to all patients accessing the healthcare setting for care of the indicator condition"
16225509|NCT01196468|Other|Interview|Demographic data will be collected for each patient consenting to an HIV test. With informed written consent, additional data will be collected from patients via focussed interview. Data comprises: previous medical history, previous health seeking behaviours, previous HIV testing history, previous viral hepatitis testing/diagnosis history, and assessment of HIV acquisition risk factors
16225510|NCT01196455|Drug|Capecitabine and Mitomycin C|"Capecitabine 1000 mg/m2 twice-daily, administered orally on day 1-14, every three weeks
~Mitomycin C 8 mg/m2 i.v. bolus, on day 1, every three weeks"
16225511|NCT01196442|Other|electrical stimulation pain therapy|Electrical stimulation pain therapy for 45 minutes on Day 1, then 30 minutes Days 2-10
16225512|NCT01196442|Other|questionnaire administration|Brief Pain Inventory questionnaire administration at baseline, weekly, then monthly for 3 months
16225513|NCT01196429|Drug|Carboplatin|Given IV
16225514|NCT01196429|Drug|Docetaxel|Given IV
16225515|NCT01196429|Other|Laboratory Biomarker Analysis|Correlative studies
16225516|NCT01196429|Drug|Paclitaxel|Given IV
16225517|NCT01196429|Drug|Temsirolimus|Given IV
16225518|NCT01196416|Drug|Cisplatin|Given IV
16225519|NCT01196416|Drug|Gamma-Secretase Inhibitor RO4929097|Given PO
16225520|NCT01196416|Other|Laboratory Biomarker Analysis|Correlative studies
16225521|NCT01196416|Other|Pharmacological Study|Correlative studies
16225522|NCT01196416|Drug|Temozolomide|Given PO
16225523|NCT01196416|Drug|Vinblastine Sulfate|Given IV
16225524|NCT01196403|Other|questionnaire administration|
16225525|NCT01196403|Procedure|quality-of-life assessment|
16225526|NCT01196403|Procedure|robot-assisted laparoscopic surgery|
16225527|NCT01196403|Procedure|therapeutic conventional surgery|
16225528|NCT01196403|Procedure|therapeutic laparoscopic surgery|
16225529|NCT01196390|Drug|Carboplatin|Given IV
16225530|NCT01196390|Other|Laboratory Biomarker Analysis|Correlative studies
16225531|NCT01196390|Drug|Paclitaxel|Given IV
16225532|NCT01196390|Other|Quality-of-Life Assessment|Ancillary studies
16225533|NCT01196390|Radiation|Radiation Therapy|Undergo radiation therapy
16225534|NCT01196390|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16225535|NCT01196390|Biological|Trastuzumab|Given IV
16225536|NCT01196377|Drug|Albuterol|Nebulized albuterol
16225537|NCT01196364|Other|Dietary Supplement: water with noncalorie sweetener|
16225538|NCT01196364|Other|Activity: With noncalorie sweetener or glucose|
16225539|NCT01196351|Other|Dietary Supplement: water with noncalorie sweetener|
16225540|NCT01196351|Other|Activity: With noncalorie sweetener or glucose|
16225541|NCT01196338|Behavioral|Early weight-bearing and range of motion exercises|"0 weeks to 2 weeks: Posterior plaster slab or cast, non-weightbearing, crutches;
~At 2 week visit to clinic: Posterior plaster slab or cast removed, staples/stitches removed placed in orthosis, with instructions to be weightbearing as tolerated. Instructions for limited range of motion to be given;
~At 2 weeks to 6 weeks: Weightbearing as tolerated in orthosis, follow range of motion instructions;
~After 6 weeks: Instructions to continue weightbearing as tolerated, wean from orthosis."
16225542|NCT01196338|Behavioral|non-weight bearing, no range of motion|"0 weeks to 2 weeks: Posterior plaster slab or cast, non-weightbearing, crutches;
~At 2 week visit to clinic: Posterior plaster slab or cast removed, staples/stitches removed, BK fibreglass cast or other orthosis applied, with instructions to continue non-weightbearing;
~At 2 weeks to 6 weeks: Ankle remains immobile and non-weightbearing;
~After 6 weeks: Begin weightbearing as tolerated. Instructions for limited range of motion to be given, and wean from orthosis."
16225543|NCT01196312|Behavioral|Anxiety sensitivity therapy|ASTH consists of 6 sessions of individual treatment, each lasting approximately 75 minutes over 3 weeks. In general, each session consists of the following components1) psychoeducation regarding the anxiety response, with a focus on increasing awareness of the ways in which the patient interprets or evaluates that response 2) assistance in developing healthy emotion regulation strategies that can be used to increase acceptance and tolerance of the anxiety response (including associated catastrophic thoughts), as well as understanding the consequences associated with avoidance or control of anxiety 3) a minimum of 3 interoceptive exercises tailored to activate feared anxiety-related sensations and 4) daily homework assignments (i.e., daily anxiety monitoring and interoceptive exercises).
16225544|NCT01196286|Behavioral|Multifamily Group Psychoeducation (MFG)|Participation in multifamily psychoeducation comprised of (i) three individual sessions with family and individual with psychosis, (ii) one psychoeducational workshop, and (iiI) twice monthly multifamily meetings to complete structured problem-solving activity
16225545|NCT01196286|Behavioral|Cognitive Remediation (CR)|Computer exercises designed to improve cognitive functioning (3hr/wk).
16225546|NCT01196273|Other|Comprehensive non invasive cardiovascular examination|"The examination includes:
~Anamnesis incl. admission form
~Physical examination
~Documentation of the medical therapy (incl. HAART)
~Electrocardiogram
~Transthoracic echocardiography
~Exercise electrocardiogram
~6 minute walk test
~Blood collection
~Questionnaire to quality of life and health economics"
16225547|NCT01196260|Drug|Capecitabine and Oxaliplatin|Capecitabine and Oxaliplatin will be under the NSCLC guideline
16225548|NCT01196247|Drug|Drug will be recommended based on IHC/Fish, CGH and Pan-XenoBank|FDA approved drugs as indicated by molecular profiling
16225549|NCT01196234|Drug|Paclitaxel/Carboplatin/Gefitinib|paclitaxel (175mg/m2 on day 1)/carboplatin (AUC 5 on day 1)/daily gefitinib 250mg/day during day 2-15
16226962|NCT01185886|Genetic|mutation analysis|
16225552|NCT01196195|Drug|Kaletra dosed once daily|Lopinavir/Ritonavir tablets. Dose = 200/50mg or 100/25mg. Frequency = once daily.
16225553|NCT01196195|Drug|kaletra dosed twice daily|Lopinavir/Ritonavir tablets. Dose = 200/50mg or 100/25mg. Frequency = twice daily.
16225554|NCT01196169|Drug|Daptomycin|One dose of Daptomycin 6 mg/Kg iv, will be infused over 30 minutes. The infusion will start no longer than one hour prior to surgical incision of primary knee or hip prosthetic joint arthroplasty.
16225555|NCT01196169|Drug|Vancomycin|Two doses of vancomycin 15 mg/Kg iv, with a maximum of 2 grams with each dose be infused over 60-120 minutes according to the dose. The first dose infusion will start no longer than one hour (if ≤ one gram), or no longer than two hours (if > one gram) prior to surgical incision of primary knee or hip prosthetic joint arthroplasty. A second similar dose will be given 12 hours after the first dose unless the patient has a creatinine clearance of < 50 ml/min. Patients with creatinine clearance of < 50 ml/min will only receive one dose.
16225556|NCT01196130|Behavioral|Cancer Symptom Questionnaire|5 minute questionnaire(s) completed at each study visit.
16225557|NCT01196130|Other|Biomarker Testing|Blood draw at each study visit for biomarker and cytokine testing.
16225558|NCT01196117|Device|14 days of placebo therapy|14 days of placebo therapy - use of guaifenesin with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation
16225559|NCT01196117|Device|14 days of CPAP therapy|14 days of continuous positive airway pressure (CPAP) therapy with salivary cortisol measurement and Epworth Sleepiness Score (ESS) documentation
16225560|NCT01196104|Drug|Technosphere® Insulin Inhalation Powder|
16225561|NCT01196104|Drug|Insulin Aspart|Usual Care
16225562|NCT01196104|Drug|Insulin Glargine|
16225563|NCT01196091|Drug|LY2127399|120 mg administered via subcutaneous (SC) injection for 52 weeks. 240 mg loading dose will be administered as the first dose of study drug.
16225564|NCT01196091|Drug|Placebo every 2 weeks|Administered via subcutaneous injection for 52 weeks. A matching loading dose of corticosteroids, NSAIDs, antimalarials, or immunosuppressants will also be administered at the first dose
16225565|NCT01196091|Drug|Placebo every 4 weeks|Administered via subcutaneous injection for 52 weeks.
16225566|NCT01196091|Drug|Standard of Care|
16225567|NCT01196078|Drug|erlotinib [Tarceva]|150 mg, orally once a day for up to 6 cycles of 21 days each
16225568|NCT01196078|Drug|vinorelbine|60 mg/m2, orally on days 1 and 8 of cycle 1, 80 mg/m2 for the other cycles
16225569|NCT01196065|Drug|RO5313534|single oral dose
16225570|NCT01196065|Drug|memantine|multiple doses to steady state
16225571|NCT01196052|Drug|Trastuzumab emtansine|Trastuzumab emtansine was provided as a single-use lyophilized formulation in a glass vial.
16225572|NCT01196039|Drug|MEMP1972A|Intravenous repeating dose
16225573|NCT01196039|Drug|placebo|Intravenous repeating dose
16225574|NCT01196026|Biological|Fluarix™|One or two intramuscular injections
16225575|NCT01196026|Biological|Havrix™ Junior|Two intramuscular injections
16225576|NCT01196013|Drug|Clofarabine|Intravenous, 30 mg/m2, 52 mg/m2
16225577|NCT01196000|Procedure|conventional laparoscopic surgery|operation using conventional laparoscopic techniques
16225578|NCT01196000|Procedure|robotic-assisted laparoscopic surgery|operation that involves use of laparoscopic assistance with robotic assistance
16225579|NCT01196000|Procedure|quality-of-life assessment|Ancillary studies
16225580|NCT01196000|Other|questionnaire administration|Ancillary studies
16225581|NCT01195974|Drug|YASMIN|YASMIN for 21 days
16225582|NCT01195974|Drug|GSK2248761|200 mg GSK2248761 taken on Days 1 - 10 or Days 12 - 21
16225583|NCT01195974|Other|Placebo|Placebo taken on Days 1 - 10 or Days 12 - 21
16225584|NCT01195948|Drug|B27PD|
16225585|NCT01195948|Drug|Placebo|Capsule with no active ingredients to mimic B27PD
16225586|NCT01195922|Drug|Sirolimus|21 evaluable subjects will take rapamycin (sirolimus) orally once per day for 21 days. Before and after dosing tumor assessments to include: photographs, CT & amp; PET scans will be done for tumor measurement.
16225587|NCT01195896|Device|New NPWT system|According clinical routine (Instruction for Use)
16225588|NCT01195883|Drug|Crystalloid|For goal directed volume management we use corrected aortic flow time (FTc) and stroke volume derived from esophageal Doppler as in previous studies. In case of hypovolemia, detected by esophageal Doppler monitoring (CardioQ, Deltex Medical Group PLC, Chichester, UK) according to a previously published algorithm, an additional fluid bolus of 250 ml of LR will be given over a period of 5 minutes.
16225589|NCT01195883|Drug|Colloid|For goal directed volume management we use corrected aortic flow time (FTc) and stroke volume derived from esophageal Doppler as in previous studies. In case of hypovolemia, detected by esophageal Doppler monitoring (CardioQ, Deltex Medical Group PLC, Chichester, UK) according to a previously published algorithm, an additional fluid bolus of 250 ml of Hydroxyethylstarch 6% 130/0.4 (Voluven®Fresenius-Kabi, Bad Homburg, Germany) will be given over a period of 5 minutes.
16225590|NCT01195844|Biological|Rotavirus Vaccine|This is an observational study evaluating hospitalizations and the medical care for the treatment of diarrhea from rotavirus infection in children < 5 years of age; however, any rotavirus vaccines used in the children presenting with rotavirus-attributed diarrhea were evaluated, as well the prevalent rotavirus serotypes in this sample for future vaccine development.
16225591|NCT01195831|Drug|Xamiol® gel|Once daily application
16225592|NCT01195831|Drug|Calcipotriol scalp solution|Twice daily application
16225593|NCT01195818|Drug|RAS Inhibitors|Clinical trial testing the effect of RAS inhibitors (Ramipril or Irbesartan)on sickle cell disease patients wit hyperfiltration and albuminuria for a six month period followed by one month wash out period. Drug will be given after the first GFR measurement on a daily basis with a full dose given after the first month.
16225594|NCT01195805|Drug|Spironolactone|1 tablet twice a day for 28 days
16225595|NCT01195805|Other|Placebo|1 tablet twice a day for 28 days
16225596|NCT01195805|Drug|Amiloride|1 tablet twice a day for 28 days
16225597|NCT01195792|Drug|GSK1521498|GSK1521498 2mg or 5mg will be given for up to 35 days and subjects will be assessed weekly
16225598|NCT01195792|Drug|Placebo|Placebo will be given for up to 35 days and subjects will be assessed weekly
16225599|NCT01195779|Biological|GSK Bio's influenza vaccine GSK2584786A, different formulations|Intramuscular injections
16225602|NCT01195766|Drug|Ofatumumab|Ofatumumab in addition with ESHAP therapy
16225603|NCT01195753|Biological|HHLivC|multiple infusion of liver cells
16225604|NCT01195740|Behavioral|Attachment Based Family Therapy|ABFT has three phases. In phase one, treatment focuses on helping the adolescent identify past and present family conflicts that have strained the attachment bond and damaged trust. Adolescents and parents are taught new communication and affect regulation skills in preparation for reparative conversations in phase two. This phase of treatment involves adolescents and parents discussing these past and present conflicts using their new communication skills. The final phase of treatment focuses on promoting adolescent autonomy (i.e., improving school productivity, finding a job, etc.). For the suicidal/depressed adolescent, this can decrease isolation and increase exposure to positive experiences. To accomplish these goals, there are five ABFT treatment tasks. Each task may take one or several sessions. Youth randomized to this condition will receive approximately 14 weeks of ABFT. One orientation meeting will occur, whenever possible, on the inpatient unit prior to discharge.
16225605|NCT01195740|Behavioral|Enhanced Usual Care|"Belmont offers the Therapeutic Bridge Program, funded by the Pew Charitable Trusts, which helps adolescents make the transition from the hospital back to home, school and community behavioral health services. The program serves as a bridge between inpatient and outpatient care during the first 90 days after discharge, linking them to supportive services. Aftercare begins at the point of intake. Several discharge planning meetings are held with the adolescent and parents during the inpatient stay. The range of services are based on the patient and families' need, and may include meeting with school personnel , conducting home visits or making referrals to other community services agencies. The main objective is to secure outpatient mental health services for the patient. These services will be enhanced by the weekly research tracking, assessment and 24-hour crisis phone line which will call into a cell phone rotated among the licensed mental health professionals on the research team."
16225606|NCT01195727|Drug|Apixaban|
16225607|NCT01195714|Drug|Ofatumumab|solution for perfusion, 1000mg per cycle, 1 cycle every 3 weeks, total 6 cycles
16225608|NCT01195688|Drug|BI 638683 or placebo|oral doses given to 6 subjects per dose group
16225609|NCT01195688|Drug|Placebo solution|oral doses given to 2 subjects per dose group
16225610|NCT01195675|Drug|BI 10773 (low)|single oral dose
16225611|NCT01195675|Drug|Moxifloxacin|single oral dose
16225612|NCT01195675|Drug|BI 10773 Placebo|2 times single dose
16225613|NCT01195675|Drug|BI 10773 (high)|single oral dose
16225614|NCT01195662|Drug|Dapagliflozin|Tablets, Oral, 10 mg, once daily, Up to 12 weeks
16225615|NCT01195662|Drug|Placebo matching Dapagliflozin|Tablets, Oral, 0 mg, once daily, Up to 12 weeks
16225616|NCT01195649|Drug|Sorafenib (Nexavar, BAY43-9006)|Patients under daily life treatment according to local drug information
16225617|NCT01195636|Drug|XPF-002|Twice daily application of XPF-002 ointment which contains 8% of the XPF-002 active ingredient
16225618|NCT01195636|Drug|Placebo|Twice daily application of Placebo ointment
16225619|NCT01195623|Procedure|preoperative duplex examination|
16225620|NCT01195623|Procedure|Preoperative duplex|
16225621|NCT01195610|Behavioral|Dietary intervention|Instruction to diet for 6 month
16225622|NCT01195597|Device|E-Cigarette 7.2 mg nicotine|"Participants were given a free e-Cigarette kit containing two rechargeable batteries, a charger, and two atomizers and instructed on how to charge, activate and use the e-Cigarette. Key troubleshooting were addressed and phone numbers were supplied for both technical and medical assistance. A full 4-weeks supply of 7.2 mg nicotine cartridges (Original cartridges; Arbi Group Srl, Milano, Italy) was also provided and participants were trained on how to load them onto the e-Cigarette's atomizer"
16225623|NCT01195571|Biological|cmv vaccine|dose escalation study of 4 towne-toledo chimera vaccines
16225624|NCT01195558|Other|Data collection on blindness and sleep problems|Data related to degree of vision impairment and sleep problems is collected through a phone or web survey
16225625|NCT01195545|Device|Veritas® Collagen Matrix|biological mesh in hernia repair
16225626|NCT01195493|Other|Essential Oils solution|(Essential oils solution, Listerine®, Johnson & Johnson) to use twice a day (2 x 20 ml) following daily mechanical oral hygiene practices
16225627|NCT01195493|Other|negative control solution|this solution would be used twice per day (2 x 20 ml) following daily home care.
16225628|NCT01195480|Genetic|donor-derived EBV-specific cytotoxic T-cells (EBV-CTL) transduced with the retroviral vector SFGalpha-CD19-CD3zeta|All patients will be treated at the same total dose level of 2 x 10^8/m2
16225629|NCT01195480|Biological|Irradiated donor-derived Lymphoblastoid Cell Line|"The initial cohort of 5 patients (regardless of arm of study) will be treated as described. If transduced CTL infusion is safe in this initial cohort and real-time DNA PCR studies demonstrate that transduced CTL are undetectable in > 50% of patients by 2 months post-infusion, the remaining 25 patients (in either arm of the study) will be treated as above but with an additional vaccination of CD19-zeta-transduced EBV-LCL infusion.
~Vaccination will consist of 3 doses of 5 x 10^6 irradiated (70Gy) donor-derived EBV-lymphoblastoid cell line used to generate CTL and will be administered subcutaneously into the thigh (volume 0.3 ml) at day -2, week 4 and 8 post-transduced CTL infusion."
16225630|NCT01195467|Drug|Truvada/Raltegravir|All subjects currently on Atripla® will switch to Truvada/Raltegravir
16225631|NCT01195454|Drug|Insulin glargine (HOE901)|"Pharmaceutical form: Lantus solution for injection
~Route of administration: subcutaneous"
16225632|NCT01195454|Drug|Insulin glargine (HOE901)|"Pharmaceutical form: New insulin glargine formulation solution for injection
~Route of administration: subcutaneous"
16225633|NCT01195428|Drug|Simvastatin|Simvastatin 40 mg daily
16225634|NCT01195428|Drug|Placebo|Placebo
16225635|NCT01195415|Drug|Gemcitabine Hydrochloride|Given IV
16225636|NCT01195415|Other|Laboratory Biomarker Analysis|Correlative studies
16225637|NCT01195415|Drug|Vismodegib|Given PO
16225638|NCT01195402|Procedure|pulmonary outpatient rehabilitation|Subjects take part in once weekly training sessions of 60 min duration. Sessions take place in local physiotherapist practice and involve simple training devices (chairs, elastic bands, balls). In addition, subjects take part in a structured and validated educational program concerning COPD (COBRA) of 8 h duration. They are offered counselling regarding nutrition (2 h), psycho-social (2 h) and social (2 h) aspects.
16225639|NCT01195389|Device|Resonator|Treatment group vs. Placebo group
16225640|NCT01195376|Drug|BEZ235|
16225641|NCT01195363|Drug|quetiapine SR|quetiapine SR, dose range 200-600mg, each night QHS for 6mos
16225642|NCT01195363|Drug|quetiapine sr placebo|quetiapine sr placebo, dose range 200-600mg, each night QHS for 6mos
16225643|NCT01195337|Behavioral|PA Prescription Plan|Exercise program and instructions.
16225644|NCT01195337|Device|Pedometer|Step monitor for individual PA progress.
16225645|NCT01195337|Behavioral|Newsletters|4 Newsletters with topics based on PA progression phases of adoption and maintenance.
16225646|NCT01195324|Drug|Canagliflozin/Warfarin|Treatment A: Tablets, oral, canagliflozin 300 mg, once daily for 12 days and canagliflozin 300 mg + warfarin 30 mg, single dose on Day 6 followed 14 days later by Treatment B: Tablets, oral, warfarin 30 mg, single dose on Day 1
16225647|NCT01195324|Drug|Canagliflozin/Warfarin|Treatment B: Tablets, oral, warfarin 30 mg, single dose on Day 1 followed 14 days later by Treatment A: Tablets, oral, canagliflozin 300 mg, once daily for 12 days and canagliflozin 300 mg + warfarin 30 mg, single dose on Day 6
16225648|NCT01195311|Drug|INCB024360|INCB024360: 25 mg and 100 mg tablets Doses will be escalated in accordance with the dosing schedule.
16225649|NCT01195298|Drug|Capecitabine and Bevacizumab|"Drugs will be administered in 3-week cycles as follows:
~Bevacizumab 15mg/kg via i.v. infusion on day 1
~Capecitabine 1000 mg/m2 tablets twice-daily, on days 1 through 14."
16225650|NCT01195285|Procedure|Single-Incision Laparoscopic Surgery cholecystectomy|Laparoscopic Cholecystectomy
16225651|NCT01195285|Procedure|Traditional Laparoscopic Cholecystectomy (TLC)|Laparoscopic Cholecystectomy
16225652|NCT01195272|Drug|tocilizumab [RoActemra/Actemra]|8 mg/kg iv every 4 weeks, 52 weeks
16225653|NCT01195259|Drug|allocation of treatment with metformin or rosiglitazone|Subjects from ADOPT that are included in this meta-analysis were randomly allocated to receive metformin or rosiglitazone. Subjects from RECORD that are included in this meta-analysis were taking one of three sulfonylureas (glibenclamide, gliclazide or glimepiride) and were randomly allocated metformin or rosiglitazone to use as add-on treament to background sulfonylurea.
16225654|NCT01195246|Biological|HEPLISAV|Intramuscular (IM) injection on Day1
16225655|NCT01195246|Biological|Engerix-B|Intramuscular (IM) injection on Day 1
16225656|NCT01195246|Biological|Fendrix|Intramuscular (IM) injection on Day 1
16225657|NCT01195233|Drug|bioxtra|spray /mouth rinse
16225658|NCT01195220|Behavioral|HIV testing|This is the current standard of care. It obtains consent for HIV vesting by a proven video, and provides rapid HIV testing on site. Informed consent video includes information about the test and its interpretation, as mandated by New York State Law. The the OraQuick ADVANCE® Rapid HIV- 1/2 Antibody Test
16225659|NCT01195220|Behavioral|STI/HIV-T|This intervention adds testing for GC and CT to HIV testing. The informed consent video will incorporate information for STIs to accompany information presented on HIV. GC and CT screening is conducted via a urine sample. The APTIMA Combo 2 Assay has been cleared by the Food and Drug Administration for sale in the US. It employs Gen-Probe's patented Transcription-Mediated Amplification (TMA) technology to detect CT and GC using urine specimens for both male and female patients. We will test urine for GC and CT at the ED visit using the hospital lab within the urban ED.
16225660|NCT01195220|Behavioral|STI/HIV-Plus|This intervention includes the combined STI/HIV testing, and adds the behavioral video that encourages safer sex and is targeted to the participants' stage of change. While patients wait for their HIV test result (20-30 minutes), patients will view these video vignettes.
16225661|NCT01195207|Biological|CNTO 3157 or placebo|0.003 mg/kg CNTO 3157 or placebo infusion
16225662|NCT01195207|Biological|CNTO 3157 or placebo|0.03 mg/kg CNTO 3157 or placebo infusion
16225663|NCT01195207|Biological|CNTO 3157 or placebo|10 mg/kg CNTO 3157 or placebo infusion
16225664|NCT01195207|Biological|CNTO 3157 or placebo|0.01 mg/kg CNTO 3157 or placebo infusion
16225665|NCT01195207|Biological|CNTO 3157 or placebo|1 mg/kg CNTO 3157 or placebo infusion
16225666|NCT01195207|Biological|CNTO 3157 or placebo|3 mg/kg CNTO 3157 or placebo infusion
16225667|NCT01195207|Biological|CNTO 3157 or placebo|0.3 mg/kg CNTO 3157 or placebo infusion
16225668|NCT01195207|Biological|CNTO 3157 or placebo|0.1 mg/kg CNTO 3157 or placebo infusion
16225669|NCT01195194|Drug|PRE-TRANSPLANT (PRE=before)|"All patients will start with Thymoglobulin 1 mg/kg before transplant followed by 0,5 mg/kg/d during the next 5 days (total accumulated 3,5 mg/kg).
~Steroids will be administered at 0,25 mg/kg/d until month 3rd, followed by 0,1 mg/kg/d thereafter.
~Mycophenolate Mofetil: Pre-transplant 2 grams iv. After transplantation 1g/12 hours, starting iv and changing to oral formulation as soon as patient starts with oral intake (targeting mycophenolic acid (MPA) C0h levels 2-5 µg/mL)."
16225670|NCT01195181|Drug|peginterferon plus ribavirin|peginterferon alfa-2a at 180ug/week (preempt syringe, sc) or peginterferon alfa-2b at 1,5 ug/kg/week (standard dose) or at 1,0 ug/kg/week (lower dose)(preempt pen, sc) for 24 or 48 week in relation to HCV genotype plus ribavirin (capsules, po) at 15mg/kg/daily combination therapy.
16225671|NCT01195155|Dietary Supplement|LC n-3 PUFA (fish oil) Supplement|4 x 1g LC n-3 PUFA (fish oil)supplement containing 1.9g EPA and DHA given daily for 6 weeks
16225672|NCT01195129|Device|MicroVention Hydrogel coil|Micro Vention Hydrogel Coils
16225673|NCT01195129|Device|Non-hydrogel coils|Cerecyte or bare platinum coils
16225674|NCT01195116|Drug|Dexmedetomidine|1 mcg/kg/hour
16225675|NCT01195116|Drug|Normal Saline|1mcg/kg/hr
16225676|NCT01195103|Drug|Fospropofol disodium|10 mg/kg bolus
16225677|NCT01195103|Drug|Fospropofol disodium|6.5 mg/kg bolus
16225678|NCT01195103|Drug|Placebo + Midazolam|Placebo bolus plus midazolam. The dose of midazolam will be based on the patient's weight: 1 mg for patients <60 kg; 1.5 mg for patients ≥60 kg to <90 kg; or 2 mg for patients ≥90 kg
16225679|NCT01195103|Drug|Fentanyl|All patients will receive a single dose of IV fentanyl (approximately 1 μg/kg not to exceed: 50 μg for patients <60 kg; 75 μg for patients ≥90 kg) five minutes prior to the initial dose of sedative.
16225680|NCT01195090|Drug|Sitagliptin|add sitagliptin100mg/d to pre-study OADs
16225681|NCT01195090|Drug|pioglitazone|add pioglitazone 30mg/d to pre-study OADs
16225727|NCT01194713|Behavioral|Sleep deprivation|subjects will undergo one night of full sleep deprivation
16225728|NCT01194700|Drug|Seretide 250(8puffs) via Evohaler actuator|8 puffs of Seretide250/Placebo via Evohaler actuator
16225781|NCT01194336|Drug|Huperzine A|dosage form: tablet dose frequency: once only
16225682|NCT01195077|Other|seaweed, spirulina, seaweed + spirulina|"Arm 1: Seaweed. Ten capsules of .5 grams per capsule for a total of 10 grams per day.
~Arm 2: Spirulina: Ten capsules of .5 grams per capsule for a total of 10 grams per day.
~Arm 3: Seaweed: (2.5 grams) plus Spirulina (2.5 grams). Ten capsules of .5 grams per capsule for a total of 10 grams per day.
~Spirulina: Ten capsules of .5 grams per capsule for a total of 10 grams per day."
16225683|NCT01195051|Other|Electronic medication reconciliation|A new, computer-based application will be used to document and prescribe outpatient medications in the inpatient setting.
16225684|NCT01195038|Biological|Recombinant Influenza HA Vaccine (H5N1)|one booster dose of 45 μg rHA derived from A/Indonesia/05/2005 strain
16225685|NCT01195025|Drug|acetated Ringers|Infusion of Ringer acetate 20 ml/kg over 30 min
16225686|NCT01195025|Drug|colloid|Infusion of starch 10 ml/kg over 30 min
16225687|NCT01195025|Drug|colloid+acetated Ringer|Infusion of combined colloid+acetated Ringer; 10 ml/kg of starch was infused between 0 and 30 min, followed by 20 ml/kg of Ringers acetate between 105 and 135 min.
16225688|NCT01195025|Device|Non-invasive hemoglobin with pulse-oximeter (SpHb)|Non-invasive hemoglobin with pulse-oximeter (SpHb) was measured in all subjects, during all infusions.
16225689|NCT01195012|Behavioral|Helping HAND (Healthy Nutrition and Activity Directions)|6-month behavioral intervention targeting 5-8 year old children and their parents to improve the child's lifestyle behaviors to improve their weight status. The families met monthly with trained Health Advisors for individual sessions in the pediatric clinic with phone calls in between visits to check on progress.
16225690|NCT01194999|Device|Pubovaginal sling procedure|The procedure involves placing a band of sling material directly under the bladder neck (ie, proximal urethra) or mid-urethra, which acts as a physical support to prevent bladder neck and urethral descent during physical activity. The sling also may augment the resting urethral closure pressure with increases in intra-abdominal pressure.
16225691|NCT01194986|Other|[11C]AZ12807110|Radioligand
16225692|NCT01194986|Drug|AZD5213|
16225693|NCT01194973|Drug|Eculizumab|All patients received open-label eculizumab administered intravenously on the following dose schedule: Induction dose - 900 mg per week for four weeks and a dose of 1200 mg one week later; Maintenance dose - 1200 mg every two weeks. Patients who received plasma exchange or infusion during the eculizumab treatment period received a supplemental dose of 600 mg within one hour before plasma infusion or within one hour after the completion of each plasma exchange.
16225694|NCT01194960|Drug|Docetaxel|Subjects will receive 10 cycles of Docetaxel alone until toxicity or progression.
16225695|NCT01194960|Drug|TroVax|Trovax on Days 1,10, 22 and then Weeks 7, 10, 13, 19, 25, 31 and 37
16225696|NCT01194947|Device|RCM imaging|RCM imaging will be performed using a commercially-available RCM (Vivascope 1500, Lucid Inc, Rochester, NY, USA) with 830-nm diode laser with emitting power less than 35 milliwatts
16225697|NCT01194934|Drug|NOX-A12|4 mg/kg daily IV for 5 days
16225698|NCT01194934|Drug|NOX-A12|2 mg/kg daily IV for 5 days
16225699|NCT01194934|Drug|Filgrastim|5 µg/kg SC daily for 5 days
16225700|NCT01194934|Drug|NOX-A12 in combination with Filgrastim|Safe and efficacious dose regimen according to results of groups A and B
16225701|NCT01194908|Drug|Decitabine, LBH589, Tamoxifen|"Dose level -1; Decitabine (IV)(D1-5): 5mg/m2; LBH589 (IV)(D1,8): 10mg/m2
~Dose level 0; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 10mg/m2
~Dose level +1; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 15mg/m2
~Dose level +2; Decitabine (IV)(D1-5): 10mg/m2; LBH589 (IV)(D1,8): 20mg/m2
~Dose level +3; Decitabine (IV)(D1-5): 15mg/m2; LBH589 (IV)(D1,8): 20mg/m2
~Dose level +4; Decitabine (IV)(D1-5): 20mg/m2; LBH589 (IV)(D1,8): 20mg/m2"
16225702|NCT01194895|Other|protective ventilation|set tidal volume of 5ml/kg during one-lung ventilation
16225703|NCT01194895|Other|conventional ventilation|keep tidal volume at 8ml/kg during one-lung ventilation
16225704|NCT01194882|Drug|HUMAN INSULIN (BIOSYNTHETIC)|Pharmaceutical form: solution for infusion Route of administration: Intraperitoneal use Dose regimen: 400 IU/ml
16225705|NCT01194882|Drug|Insuplant|"Pharmaceutical form:solution for infusion Route of administration: Intraperitoneal use
~Dose regimen:"
16225706|NCT01194869|Drug|Sorafenib|Sorafenib 400 mg twice daily throughout the study. Patients will receive this as a single-agent for the first four weeks, then in combination with cisplatin followed by paclitaxel.
16225707|NCT01194869|Drug|Cisplatin|75 mg/m² given IV
16225708|NCT01194869|Drug|Paclitaxel|175 mg/m² given IV
16225709|NCT01194856|Drug|Atazanavir/ritonavir|300 mg orally once daily with Ritonavir 100mg orally once daily for 96 weeks
16225710|NCT01194856|Drug|Efavirenz|Maintain dosage - 600 mg orally QHS for 96 weeks
16225711|NCT01194843|Drug|Ropivacaine|40 ml infiltration at the end of the hepatectomy and then continuous local infiltration of 8 ml per hour over the 4 days after the hepatectomy
16225712|NCT01194843|Drug|Physiological serum|40 ml infiltration at the end of the hepatectomy and then continuous local infiltration of 8 ml per hour over the 4 days after the hepatectomy
16225713|NCT01194830|Drug|Linagliptin|Active drug 1 tablet PO QD
16225714|NCT01194830|Drug|Placebo|1 Tablet PO QD
16225715|NCT01194817|Device|High-Flexion Knee Replacement System using Cemented Fixation|
16225716|NCT01194817|Device|High-Flexion Knee Replacement System using Cementless Fixation|
16225717|NCT01194804|Drug|Eculizumab|Each vial contains 30 mL of 10 mg/mL eculizumab; dose of 900 mg intravenous every 14 days.
16225718|NCT01194791|Drug|Lenalidomide|Lenalidomide 15 mg by mouth for 21 days followed by 7 days rest during 6 cycles
16225719|NCT01194791|Drug|Cyclophosphamide|Cyclophosphamide 300 mg/m2, on days 1 and 8 every 4 weeks during 6 cycles
16225720|NCT01194791|Drug|Dexamethasone|Oral dexamethasone 20 mg/day on days 1-4 and 9-12 given at 4-week intervals during 6 cycles
16225721|NCT01194778|Dietary Supplement|placebo|1 placebo sachet per day containing only sucrose during 12 weeks
16225722|NCT01194778|Dietary Supplement|vitamin K1|15 µg vitamin K1 per day during 12 weeks
16225723|NCT01194778|Dietary Supplement|vitamin K2|15 µg vitamin K2 per day during 12 weeks
16225724|NCT01194778|Dietary Supplement|vitamin K2|30 µg vitamin K2 per day during 12 weeks
16225725|NCT01194778|Dietary Supplement|vitamin K2|45 µg vitamin K2 per day during 12 weeks
16225726|NCT01194765|Other|Distance-based Cognitive Behavioural Therapy|Participants will engage in cognitive behavioural therapy to treat high anxiety sensitivity. Treatment will be delivered over the telephone.
16225729|NCT01194700|Drug|Seretide 250 (8 puffs)/placebo via Volumatic spacer|8 puffs of Seretide 250/placebo via volumatic spacer
16225730|NCT01194700|Drug|Seretide 250/placebo 8 puffs via Aerochamber Plus spacer|Seretide 250/placebo 8 puffs via Aerochamber Plus
16225731|NCT01194700|Drug|Seretide 250/placebo via Synchro-Breathe|Seretide 250/placebo 8puffs via breath actuated Synchro-Breathe device
16225732|NCT01194674|Drug|Microplasmin|Participants received an intravitreal injection of 125 µg in 100 µL of microplasmin at baseline.
16225733|NCT01194648|Other|questionnaire administration|
16225734|NCT01194648|Procedure|assessment of therapy complications|
16225735|NCT01194648|Procedure|high-intensity focused ultrasound ablation|
16225736|NCT01194648|Procedure|multiparametric magnetic resonance imaging|
16225737|NCT01194648|Procedure|quality-of-life assessment|
16225738|NCT01194648|Procedure|transperineal prostate biopsy|
16225739|NCT01194648|Procedure|transrectal prostate biopsy|
16225740|NCT01194635|Genetic|fluorescence in situ hybridization|
16225741|NCT01194635|Genetic|gene expression analysis|
16225742|NCT01194635|Genetic|polymerase chain reaction|
16225743|NCT01194635|Genetic|protein analysis|
16225744|NCT01194635|Genetic|protein expression analysis|
16225745|NCT01194635|Other|enzyme-linked immunosorbent assay|
16225746|NCT01194635|Other|immunohistochemistry staining method|
16225747|NCT01194635|Other|laboratory biomarker analysis|
16225748|NCT01194622|Drug|Azelastine, Fluticasone|TEST = MP29-02 = Combination product Azelastine Hydrochloride and Fluticasone Propionate nasal spray (= US formulation as used in pivotal studies)
16225749|NCT01194622|Drug|Fluticasone mono|REF = FLU mono Fluticasone Propionate nasal spray (= essentially combination product formulation without any AZE; US FLU mono formulation as used in pivotal studies)
16225750|NCT01194622|Drug|Fluticasone|COMP = Fluticasone Propionate Nasal Spray, Roxane Laboratories = FLU mono Fluticasone propionate nasal spray (= US marketed product)
16225751|NCT01194609|Biological|Immune cell|InnoLak two consecutive weeks every 3 weeks for 3 times
16225752|NCT01194609|Radiation|Low dose radiation|20cGy whole body radiation every three weeks for three times
16225753|NCT01194596|Behavioral|Smoking cessation advice|Brief but structured smoking cessation advice (according to the standards of the Tobacco Study Group of the Catalan Society of Family Medicine).
16225754|NCT01194596|Behavioral|Spirometry and smoking cessation advice|Intervention group: will be given a brief but structured smoking cessation advice (according to the standards of the Tobacco Study Group of the Catalan Society of Family Medicine) together with a detailed and structured discussion of the spirometric results.
16225755|NCT01194570|Drug|Ocrelizumab|Two IV infusions of 300 mg in each treatment cycle of double blind treatment period; two IV infusions of ocrelizumab 300 mg for Cycle 1 and single IV infusion of ocrelizumab 600 mg for subsequent cycles in OLE phase.
16225756|NCT01194570|Other|Placebo|Two IV infusions of placebo matched to ocrelizumab in each treatment cycle of double blind treatment period.
16225757|NCT01194557|Device|Rapid diagnostic test|Diagnosis of malaria using rapid diagnostic test
16225758|NCT01194557|Drug|Lumartem|Presumptive treatment of malaria/fever
16225759|NCT01194531|Device|24 Chromosome Aneuploidy Screening with Parental Support|Preimplantation Genetic Screening (PGS)
16225760|NCT01194518|Behavioral|Lifestyle Intervention Program|
16225761|NCT01194505|Other|Sciatic, femoral, obturator nerve blocks|Ultrasound guided blocks with ropivacaine
16225762|NCT01194505|Other|Sciatic nerve block, posterior lumbar plexus block|Ultrasound and neurostimulator nerve blocks with ropivacaine
16225763|NCT01194492|Radiation|Albumin transcapillary escape rate (125I-albumin)|Repeated measure by injection of 0.1 megabecquerel and 0.3 megabecquerel of 125-iodine labeled albumin before surgery and 2 days after surgery, respectively.
16225764|NCT01194479|Drug|Formoterol|Formoterol inhaler, 12mcg capsules, 4 capsules for one administration
16225765|NCT01194479|Other|Placebo|Participants in both arms received placebo on 1 of the 2 visits.
16225766|NCT01194466|Device|Transcutaneous Electrical Nerve Stimulation (TENS)|Four adhesive electrodes (1.375in x 1.375in) will be placed bilaterally on the: 1) temporomandibular joint (1/3rd of distance between ear and nose); and 2) upper neck area (2cm from spine, i.e., Cervical 1 and 2).
16225767|NCT01194453|Drug|cisplatin, dexamethasone,vitamin B12, folic acid|Patients received cisplatin 75mg/m2 plus pemetrexed 500 mg/m2 on day 1.Chemotherapy was repeated every 3 weeks for a maximum of six cycles.Patients received dexamethasone prophylaxis of 3.75mg orally twice per day on the day before, the day of, and the day after each day-1 treatment. patients received oral folic acid (1,000ug)daily and a vitamin B12 injection (1,000 ug) every 9 weeks, beginning 1 to 2 weeks before the first dose and continuing until 3 weeks after the last dose of study treatment
16225768|NCT01194453|Drug|cisplatin, gemcitabine|cisplatin 75mg/m2 on day 1 plus gemcitabine 1000 mg/m2 on days 1 and 8
16225769|NCT01194440|Drug|letrozole|Given orally
16225770|NCT01194440|Drug|zoledronic acid|Given IV
16225771|NCT01194427|Drug|Vorinostat and Tamoxifen|vorinostat 400 mg PO once daily and tamoxifen 20mg PO once daily for 14 days
16225772|NCT01194414|Drug|tocilizumab SC|Tocilizumab supplied in a single-use pre-filled syringe, with a needle safety device, delivering 162 mg/0.9 mL solution for subcutaneous injection once a week.
16225773|NCT01194414|Drug|tocilizumab IV|Tocilizumab supplied in vials as a sterile solution for 8 mg/kg intravenous infusion every 4 weeks.
16225774|NCT01194414|Drug|placebo to tocilizumab SC|Placebo tocilizumab supplied as a single-use pre-filled syringe with a needle safety device, delivering 0.9 mL sodium chloride for subcutaneous injection once a week for 24 weeks in the double-blind period.
16225775|NCT01194414|Drug|placebo to tocilizumab IV|Placebo to tocilizumab supplied as a solution in 10 mL vials containing polysorbate 80 and sucrose in water for infusion every 4 weeks for a total of 24 weeks in the double-blind period.
16225776|NCT01194414|Drug|Disease-modifying antirheumatic drugs (DMARDs)|stable dose as prescribed
16225777|NCT01194388|Device|MicroFx™ PGLA COILS|. This observational evaluation will evaluate early experience using the Axium™ MicroFx™ Detachable Coils as compared to published literature of coils with electrolytic, thermal or hydraulic detachment process or the Axium™ bare Detachable Coils arm obtained from previous evaluation conducted following the same protocol.
16225782|NCT01194336|Drug|Donepezil|dosage form: tablet dosage frequency: once only
16225783|NCT01194336|Drug|Galantamine|dosage form: tablet dosage frequency: once only
16225784|NCT01194336|Other|Placebo|dosage form: tablet dosage frequency: once only
16225785|NCT01194310|Procedure|phaco|Standard clear cornea phacoemulsification plsu intraocular lens Implantation (phaco) alone
16225786|NCT01194310|Procedure|phaco-ELT|Standard clear cornea phacoemulsification plsu intraocular lens Implantation (phaco) plus excimer laser trabeculotomy (ELT)
16225787|NCT01194310|Procedure|phaco-Trabectome|Standard clear cornea phacoemulsification plsu intraocular lens Implantation (phaco) plus Trabectome
16225788|NCT01194297|Biological|Live attenuated influenza vaccine|One dose of live attenuated influenza vaccine, according to routine immunization recommendations
16225789|NCT01194297|Biological|Inactivated influenza vaccine|One dose of inactivated influenza vaccine, according to routine immunization recommendations
16225790|NCT01194284|Drug|Mifamurtide|Mifamurtide will be prescribed to patients with high-grade osteosarcoma as part of their treatment regimen within the context of prevailing standard oncology practice. The recommended dose of mifamurtide is 2 mg/m2. Mifamurtide will be administered for 36 weeks as adjuvant therapy following surgical resection.
16225791|NCT01194271|Drug|Leuprolide Acetate|22.5 mg administered as a single intramuscular 3 month depot.
16225792|NCT01194271|Drug|Ipilimumab|10 mg/kg by vein administered as 2 single doses, 3 weeks apart after hormone therapy.
16225793|NCT01194271|Procedure|Radical Prostatectomy|Surgery to remove prostate gland approximately 4 weeks after the second dose of Ipilimumab.
16225794|NCT01194258|Drug|Insulin lispro|
16225795|NCT01194258|Drug|Insulin aspart|
16225796|NCT01194258|Drug|Recombinant human hyaluronidase PH20|
16225797|NCT01194258|Drug|Insulin glulisine|
16225798|NCT01194258|Drug|Insulin glargine|
16225799|NCT01194245|Drug|Insulin lispro|
16225800|NCT01194245|Drug|recombinant human hyaluronidase PH20|
16225801|NCT01194245|Drug|Insulin aspart|
16225802|NCT01194245|Drug|Insulin glulisine|
16225803|NCT01194245|Drug|Insulin glargine|
16225804|NCT01194232|Drug|Sildenafil|8 week course of Sildenafil administered at a dose of 1 mg / Kg three times a day with a maximum dose of 20 mg per dose.
16225805|NCT01194219|Drug|Apremilast|
16225806|NCT01194219|Drug|Placebo|Identical matching placebo
16225807|NCT01194219|Drug|Topical treatments or phototherapy|At week 32, participants considered partial responders or non-responders had the option of adding topical therapies and/or phototherapy to their treatment regimen.
16225808|NCT01194206|Radiation|stereotactic body radiation therapy|At least 3 gold standard Cyberknife fiducials will be placed in the liver w/in 6 cm of the tumor for image guidance during radiation therapy. At least 1 wk will elapse between fiducial placement and tx planning simulation to allow for fiducial settling and any migration.The full radiation tx will be given ideally in 3 consecutive days. In any case there must be a minimum of 24 hrs between fractions and all 3 fractions will be delivered w/in 14 days. The dose to at least 95% of the tumor will be 37.5 Gy total in 12.5 Gy fractions.
16225809|NCT01194193|Drug|AZD8055|Oral tablet, single dose on Day 1, followed by a 48 hour - 7 day washout and then either twice daily alternate days dosing from multiple dose day 1 onwards or twice daily dosing for 21 days from multiple dose day 1 onwards followed by 7 days no treatment. Cycles of 28 days.
16225810|NCT01194180|Biological|BCG: 100 microlitres ~ 2-8 x 105 pfu|BCG vaccination at day C (challenge day) then punch biopsy at day C+14
16225811|NCT01194180|Biological|MVA85A: 1 x 108 pfu BCG: 100 microlitres ~ 2-8 x 105 pfu|MVA85A vaccination at day C-28 followed by BCG vaccination at day C (challenge day) then biopsy at day C+14
16225812|NCT01194167|Drug|Eltrombopag|75 mg per day with possible dose escalation to 150 mg per day and 300 mg per day
16225813|NCT01194154|Drug|Methoxy polyethylene glycol-epoetin beta|Methoxy polyethylene glycol-epoetin beta 30 microgram (mcg) subcutaneous injection once monthly up to 24 months with sequential dose adjustments to 50 mcg or 75 mcg depending on change of hemoglobin values of more than 1.0 gram (g)/ deciliter (dL).
16225814|NCT01194154|Drug|Placebo|Placebo matching to Methoxy polyethylene glycol-epoetin beta subcutaneous injection once monthly up to 24 months.
16225815|NCT01194141|Behavioral|Exercise training|aerobic exercise training, 45-60 minutes, 3x/week, 12 weeks (3-months)
16225816|NCT01194128|Behavioral|Psychoeducational Support|The intervention is comprised of three modules, each of which has multiple components. Module One provides basic education about the clinical aspects of frailty as well as the organization and operating procedures of long-term care facilities. Module Two focuses on advanced care planning, and Module Three is designed to improve the emotional well-being of family caregivers. The intervention will be delivered via 11 sessions lasting approximately 90 minutes each distributed over a six-month period. All family caregivers will begin with the Basic Knowledge Module. Modules Two and Three will be delivered in alternating sessions, based on caregiver need and preference, a strategy successfully used in the REACH intervention trial.
16225817|NCT01194128|Behavioral|Information only control group|"Participants in the control group will receive a portion of the standardized packet of written information that is also provided to the treatment group. The fact sheets are relevant to the placement of a family member into a nursing home and are linked to the content areas covered in the intervention. Documents in this packet include Caregiving and Depression, End of Life Decision Making, and Taking Care of You: Self-Care for Family Caregivers from the Family Caregiver Alliance; and Family Involvement in Nursing Home Care, Problem Solving, and Residents' Rights from the National Citizen's Coalition. Also provided will be a resource guide containing local contact information."
16225818|NCT01194115|Drug|cephalexin & metronidazole|cephalexin at 500 mg per oral every 8 hours for a total of 6 doses
16225819|NCT01194115|Drug|placebo|placebo representing standard of care
16225820|NCT01194102|Behavioral|Community Based Exercise Program|Three supervised exercise sessions per week, including individual and group sessions aimed at strengthening, flexibility and cardiovascular exercise.
16225821|NCT01194102|Other|Living with Stroke Education program|Weekly 1 hour long education sessions on living with stroke, aimed at helping participants take better care of their health after a stroke.
16225822|NCT01194102|Other|YMCA membership|Participants have access to YMCA facilities along with up to 7 individual sessions with a fitness trainer.
16226963|NCT01185886|Genetic|polymorphism analysis|
16225823|NCT01194089|Drug|Nasal Nicotine Spray|Single 3 mg dose of nasal nicotine spray
16225824|NCT01194089|Drug|Nasal Normal Saline Spray|An isotonic solution of sodium chloride 0.65% in deionized water
16225825|NCT01194076|Behavioral|5-day intensive treatment|Exposure Based Cognitive Behavioral Therapy administered in 10 appointments over 5 days with an added focus on training parents to be exposure coaches
16225826|NCT01194063|Drug|Omega-3 fish oil lipid emulsion|daily intravenous administration of Omegaven fish oil emulsion
16225827|NCT01194037|Drug|recombinant variant of interferon-alpha 2b|SC, Weekly
16225828|NCT01194037|Drug|Peginterferon alfa-2a|SC Weekly
16225829|NCT01194024|Other|Standard of Care|bronchoscopy with collection of bronchioalveolar lavage specimen, blood samples, High-Resolution spiral computed tomography(CT)
16225830|NCT01194011|Behavioral|questionnaire|This research tool was a written questionnaire, did not do invasive or the subjects are exposed to physical danger on the experiment, so now there is no harm in this research and test more than minimal risk.
16225831|NCT01193998|Other|Treatment as per model probability|Patients randomized to the arm where the clinician is exposed to the model results should be treated as per the model probability (i.e. if the model probability suggests AHF the clinician should treat for AHF).
16225832|NCT01193998|Other|Treatment as per usual care|Patients randomized to the arm where the clinician is blinded to the model results will undergo diagnostic tests and receive treatment as per the clinician's judgment and usual care standards.
16225833|NCT01193985|Device|TIGR Matrix Surgical Mesh|Lichtenstein repair of inguinal hernia using TIGR Matrix Surgical Mesh
16225834|NCT01193972|Other|Decision aid|Decision aid to assist patients in making a decision about smoking during the perioperative period
16225835|NCT01193946|Dietary Supplement|dietary control|Seven dietary protein levels will be tested randomly on the 7 testing days: 0.10, 0.30, 0.60, 0.90, 1.2, 1.5, and 1.8 g∙kg-1∙d-1.
16225836|NCT01193933|Procedure|autologous HSCT|T-cell ALL patients recieve late consolidation with BEAM conditioning and stem cell support
16225837|NCT01193920|Biological|Group B Streptococcus Trivalent Vaccine - 20/20/20 μg|Subjects received two injections of 20/20/20 μg dose of Group B Streptococcus (GBS) Trivalent Vaccine with aluminum.
16225838|NCT01193920|Other|Saline solution|Subjects received two injection of saline solution.
16225839|NCT01193920|Biological|Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg|Subjects received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
16225840|NCT01193920|Biological|Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μg|Subjects received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
16225841|NCT01193920|Biological|Group B Streptococcus Trivalent Vaccine - 5/5/5 μg|Subjects received one injection of 5/5/5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
16225842|NCT01193920|Other|saline solution|Subjects received one injection of saline solution.
16225843|NCT01193907|Biological|NVGH Vi-CRM197 12.5 mcg|1 dose of 0.5 mL
16225844|NCT01193907|Biological|NVGH Vi-CRM197 5.0 mcg|1 dose of 0.5 mL
16225845|NCT01193907|Biological|NVGH Vi-CRM197 1.25 mcg|1 dose of 0.5 mL
16225846|NCT01193907|Biological|Vi-polysaccharide vaccine|1 dose of 0.5 mL containing 25 mcg of Vi polysaccharide
16225847|NCT01193894|Other|Profermin|Medical Food (food for special medical purposes)
16225848|NCT01193894|Other|Fresubin|Medical food (food for special medical purposes)
16225849|NCT01193881|Drug|Erlotinib Hydrochloride|Given PO
16225850|NCT01193881|Drug|Gamma-Secretase Inhibitor RO4929097|Given PO
16225851|NCT01193881|Other|Laboratory Biomarker Analysis|Correlative studies
16225852|NCT01193881|Other|Pharmacological Study|Correlative studies
16225853|NCT01193868|Drug|gamma-secretase/Notch signalling pathway inhibitor RO4929097|Given orally
16225854|NCT01193868|Other|laboratory biomarker analysis|Correlative studies
16225855|NCT01193868|Other|pharmacological study|Correlative studies
16225856|NCT01193855|Drug|dutasteride|
16225857|NCT01193855|Drug|gadolinium-chelate|
16225858|NCT01193855|Other|active surveillance|
16225859|NCT01193855|Procedure|diffusion-weighted magnetic resonance imaging|
16225860|NCT01193855|Procedure|functional magnetic resonance imaging|
16225861|NCT01193855|Procedure|prostate biopsy|
16225862|NCT01193855|Procedure|ultrasound imaging|
16225863|NCT01193842|Drug|Cyclophosphamide|Given IV
16225864|NCT01193842|Drug|Doxorubicin Hydrochloride|Given IV
16225865|NCT01193842|Drug|Etoposide|Given IV
16225866|NCT01193842|Other|Laboratory Biomarker Analysis|Correlative studies
16225867|NCT01193842|Other|Pharmacological Study|Correlative studies
16225868|NCT01193842|Drug|Prednisone|Given PO
16225869|NCT01193842|Biological|Rituximab|Given IV
16225870|NCT01193842|Drug|Vincristine Sulfate|Given IV
16225871|NCT01193842|Drug|Vorinostat|Given PO
16225872|NCT01193816|Drug|loxapine|Each patient may receive a maximum dosage of 900mg of Loxapine per day (drinkable solution through gastric probe) or the same volume of placebo. 2 initial administrations of 150 mg followed by potential readministration of 100 mg of loxapine. Maximum duration of treatment will be 14 days.The dosage by day is defined by patients' clinical condition, assessed with RASS score.
16225873|NCT01193816|Drug|Placebo|Placebo
16225874|NCT01193803|Procedure|Microbiological cultures and Molecular biology|"Biological/Vaccine: Microbiological cultures and Molecular Biology Bacteriological procedures: All solid specimens will be crushed using a mechanic apparatus. Direct examination and cultures will be performed according to the guidelines applied for osteoarticular infections. Cultures and subcultures will be incubated for 15 days to 3 months for Mycobacteria.
~Molecular procedures: DNA extraction will be based on Boom's method (QIAGEN kit and EZ1 BioRobot). Detections of bacteria will be performed by amplification and sequencing of the 16S rRNA gene. Some specific detections as the detection of Staphylococcus sp. and Mycobacterium tuberculosis will be added to this protocol."
16225910|NCT01193530|Other|Bright Light Therapy|30 minutes every day for 14 days. After enrollment on day 0, blinded phase of study intervention (i.e. daily bright light or red light) from day 1 to day 14+/-3, then proceed to the open label phase and receive daily bright light between day 15+/-3 and day 28+/-3.
16225875|NCT01193790|Procedure|Coblation channeling|"The combination of the energy and the fluid creates a plasma field containing highly ionized particles (coblation). The ionized particles have sufficient energy to break organic molecular bonds that can remove tissue selectively without excessive heat production and subsequent damage to the surrounding tissue. Treatment of the tonsillar crypts and tissue by coblation may decrease antigen and immune system interaction and inflammation."
16225876|NCT01193777|Drug|L-Carnitine|4 gram bolus followed by 8 gram in 1 L NS infused over 12 hours.
16225877|NCT01193777|Drug|Normal Saline|Bolus followed by 1 L NS infusion over 12 hours.
16225878|NCT01193764|Dietary Supplement|100% cocoa powder|A single-center, prospective, double blind, placebo controlled study will be conducted in which male subjects with very mild acne swallow capsules filled with either unsweetened 100% cocoa (Ghirardelli), hydrolyzed gelatin powder (Gelita), or a combination of the two, at baseline. The study team will fill the capsules with either 6 oz. of hydrolyzed gelatin, 6 oz. cocoa powder (Ghirardelli ©), or a 6 oz. combination of cocoa powder (Ghirardelli ©) and hydrolyzed gelatin, totaling 6oz using a capsule encapsulation sheet (holding 60 capsules that need to be filled each time). All subjects will ingest the same number of total capsules. Evaluations will be performed using clinical assessments 4 days and 7 days after baseline evaluations (+/- 1 days).
16225879|NCT01193764|Dietary Supplement|gelatin (Gelita)|A single-center, prospective, double blind, placebo controlled study will be conducted in which male subjects with very mild acne swallow capsules filled with either unsweetened 100% cocoa (Ghirardelli), hydrolyzed gelatin powder (Gelita), or a combination of the two, at baseline. The study team will fill the capsules with either 6 oz. of hydrolyzed gelatin, 6 oz. cocoa powder (Ghirardelli ©), or a 6 oz. combination of cocoa powder (Ghirardelli ©) and hydrolyzed gelatin, totaling 6oz using a capsule encapsulation sheet (holding 60 capsules that need to be filled each time). All subjects will ingest the same number of total capsules. Evaluations will be performed using clinical assessments 4 days and 7 days after baseline evaluations (+/- 1 days).
16225880|NCT01193738|Procedure|osteopathic compression of Pterygopalatine node|osteopathic compression of Pterygopalatine node
16225881|NCT01193725|Behavioral|Prolonged Exposure Therapy (PE)|Prolonged exposure therapy will consist of 10 treatment sessions lasting 90 - 120 minutes each, with additional between-session homework assignments.
16225882|NCT01193725|Behavioral|Virtual Reality Exposure Therapy (VRET)|Virtual Reality Exposure Therapy will consist of 10 treatment sessions lasting 90 -120 minutes with additional between-session homework assignments.
16225883|NCT01193725|Behavioral|Waitlist|This group will refrain from psychotherapy until after the completion of the 5 weeks of study participation
16225884|NCT01193712|Procedure|temporary left ventricular endocardial pacing|a temporary pacemaker lead will be introduced through the aortic valve to evaluate the effect of left ventricular endocardial pacing. Four different pacing sites (basal and apical septal, basal and apical lateral) will be investigated with measurement of LV dP/dtmax. Afterwards, the endocardial pacing lead will be removed.
16225885|NCT01193699|Drug|PEG-P-INF alpha-2b (P1101)|µg (starting with 50 µg), subcutaneously, 2-weekly administration
16225886|NCT01193686|Other|Peer Visitation|Trained Volunteers will visit OEF/OIF Veterans with Polytrauma Injuries to provide support.
16225887|NCT01193660|Biological|Umbilical Cord Blood Infusion|The subjects will be undertaken allogeneic umbilical cord blood infusion (total nucleated cells > 3x10^7/kg) intravenously under non-myeloablative immunosuppression (maintaining blood level of cyclosporine as 100-200ng/mL for 1 month).
16225888|NCT01193660|Drug|Erythropoietin Injection|Erythropoietin will be given as the schedule of twice a week for 4 weeks with the dosage of 500 IU/kg for 2 times intravenously and 250 IU/kg subcutaneously for 6 times.
16225889|NCT01193660|Other|Active Rehabilitation|All subjects should participate in active rehabilitation. They received two physical and occupational therapy sessions per day. Post discharge, each participant continued to receive rehabilitation therapy at least 3 days per week for additional 5 months.
16225890|NCT01193660|Other|Placebo Umbilical Cord Blood|Placebo Umbilical Cord Blood will be given except the Experimental arm. Placebo Umbilical Cord Blood was made using peripheral blood. Participants and Investigators maintained as blind.
16225891|NCT01193660|Other|Placebo Erythropoietin|Placebo Erythropoietin containing Normal Saline
16225892|NCT01193634|Device|VR 9250 / DR 9550 / CRT 9750|Active implantable defibrillators range
16225893|NCT01193621|Drug|haloperidol, PET|"Biodistribution study Intravenous 18F haloperidol(10 mCi) Dose injection two times before whole body PET scan
~D2-receptor occupancy study Group Doses No. of subjects 1 0.5 mg 4 2 1 mg 4 3 3 mg 4
~above doses will be administrated orally every 24 hours for 7 days."
16225894|NCT01193608|Drug|AAB-003 (PF-05236812)|0.5 mg/kg AAB-003, IV
16225895|NCT01193608|Drug|AAB-003 (PF-05236812)|1 mg/kg AAB-003, IV
16225896|NCT01193608|Drug|AAB-003 (PF-05236812)|2 mg/kg AAB-003, IV
16225897|NCT01193608|Drug|AAB-003 (PF-05236812)|4 mg/kg AAB-003, IV
16225898|NCT01193608|Drug|AAB-003 (PF-05236812)|8 mg/kg AAB-003, IV
16225899|NCT01193608|Other|Placebo|Placebo, IV
16225900|NCT01193595|Drug|Ombrabulin (AVE8062)|"Pharmaceutical form:Solution for infusion
~Route of administration: Intravenous"
16225901|NCT01193595|Drug|bevacizumab|"Pharmaceutical form:Solution for infusion
~Route of administration: Intravenous"
16225902|NCT01193582|Biological|Prevenar|"Dosage form: intramuscular injection Dosage: 0.5 ml
~Frequency:
~4 doses starting from 121 to < 212 days of age"
16225903|NCT01193582|Biological|Prevenar|"Dosage form: intramuscular injection Dosage: 0.5 ml
~Frequency:
~3 doses starting from 212 days to < 12 months of age"
16225904|NCT01193582|Biological|Prevenar|"Dosage form: intramuscular injection Dosage: 0.5 ml
~Frequency:
~2 doses starting from 12 months to < 24 months of age"
16225905|NCT01193582|Biological|Prevenar|"Dosage form: intramuscular injection Dosage: 0.5 ml
~Frequency:
~1 dose starting from 24 months to < 72 months of age"
16225906|NCT01193556|Device|PEAK PlasmaBlade TnA|The PEAK PlasmaBlade will be used for the tonsillectomy.
16225907|NCT01193556|Device|Traditional Electrosurgery with scalpel|Traditional electrosurgery for the tonsillectomy.
16225908|NCT01193543|Dietary Supplement|calanus oil|1 gram twice daily
16225909|NCT01193543|Dietary Supplement|olive oil|1 gram twice daily
16225964|NCT01193257|Drug|Prednisone|Prednisone tablets
16225965|NCT01193257|Drug|Orteronel Placebo|Orteronel placebo-matching tablets
16226964|NCT01185886|Other|biologic sample preservation procedure|
16225911|NCT01193530|Other|Dim Red Light Therapy|From day 1 to day 14+/-3, daily dim red light therapy for 30 minutes for 14 days where red light device accounts for placebo of the blinded phase of study intervention, then between day 15+/-3 and day 28+/-3 open label phase with daily bright light.
16225912|NCT01193530|Behavioral|Questionnaires|Weekly
16225913|NCT01193530|Behavioral|Study Diaries|Daily logs
16225914|NCT01193530|Device|Red Light Litebook|Control red light device produced by Litebook identical in appearance and dimensions to the bright light device, with the exception it emits at wavelength 680nm (i.e. red light) and at an intensity of 50 lux.
16225915|NCT01193530|Device|Bright Light Litebook|Bright light device consists of 60 LEDs with spectral emission peak at approximately 464nm and fluorescent phosphors which provide a broader, secondary spectral peak near 564nm. Collectively the emitted light appears white.
16225916|NCT01193517|Drug|Azacitidine|Starting dose level 75 mg/m2/day subcutaneously on Days 1-5 of a 21 day cycle.
16225917|NCT01193517|Drug|Capecitabine|1500 mg/m2/day by mouth twice daily in divided doses on Days 1-14 of a 21 day cycle.
16225918|NCT01193517|Drug|Oxaliplatin|Starting dose level 90 mg/m2 by vein on Day 2 of a 21 day cycle.
16225919|NCT01193517|Drug|Azacitidine MTD|Highest tolerable dose of combination azacitidine with CAPOX found in Phase I.
16225920|NCT01193504|Drug|Pred Forte|Pred Forte BID for 4 weeks postop
16225921|NCT01193504|Drug|Lotemax|Lotemax BID for 4 weeks postop.
16225922|NCT01193491|Drug|IPI-493|Capsules, ascending dose, multiple schedules
16225923|NCT01193478|Drug|GS-5885|tablet, oral, 3 mg once daily for 3 days
16225924|NCT01193478|Drug|Placebo|tablet, oral, once daily for 3 days
16225925|NCT01193478|Drug|GS-5885|tablet, oral, 10 mg once daily for 3 days
16225926|NCT01193478|Drug|Placebo|tablet, oral, once daily for 3 days
16225927|NCT01193478|Drug|GS-5885|tablet, oral, 30 mg once daily for 3 days
16225928|NCT01193478|Drug|Placebo|tablet, oral, once daily for 3 days
16225929|NCT01193478|Drug|GS-5885|tablet, oral, up to 90 mg once daily for 3 days
16225930|NCT01193478|Drug|Placebo|tablet, oral, once daily for 3 days
16225931|NCT01193478|Drug|GS-5885|tablet, oral, up to 90 mg once daily for 3 days
16225932|NCT01193478|Drug|Placebo|tablet, oral, once daily for 3 days
16225933|NCT01193478|Drug|GS-5885|tablet, oral, up to 90 mg once daily for 3 days
16225934|NCT01193478|Drug|Placebo|tablet, oral, once daily for 3 days
16225935|NCT01193465|Device|Datex Ohmeda excel anesthesia machine|maintain one of following fresh gas flow, 1 or 4 L/min (nitrous oxide:oxygen =1:1) during 2 hour with using Datex Ohmeda excel anesthesia machine after draping complete
16225936|NCT01193465|Device|Datex Ohmeda Avance anesthesia work-station|maintain one of following fresh gas flow, 0.5 or 1 or 4 L/min (nitrous oxide:oxygen =1:1) during 2 hour with using Datex Ohmeda Avance anesthesia machine after draping complete
16225937|NCT01193465|Device|Drager Cato anesthesia work-station|maintain one of following fresh gas flow, 0.5 or 1 or 4 L/min (nitrous oxide:oxygen =1:1) during 2 hour with using Drager Cato anesthesia work-station after draping complete
16225938|NCT01193465|Device|Drager Primus anesthesia work-station|maintain one of following fresh gas flow, 0.5 or 1 or 4 L/min (nitrous oxide:oxygen =1:1) during 2 hour with using Drager Primus anesthesia work-station after draping complete
16225939|NCT01193452|Drug|S-1, Leucovorin|"S-1 :
~The initial dosage of S-1 is determined by the body surface area:
~Surface area: 1.25-1.5 m2 : 50mg twice per day;upper than 1.5 m2 : 60mg twice per day
~Leucovorin:
~25mg twice per day po.
~The treatment is given for one week,and no chemotherapy is given for the following one week."
16225940|NCT01193452|Drug|leucovorin, 5-fluorouracil|"leucovorin: 400mg/m2 intravenous infusion d1;
~5-fluorouracil: 400mg/m2 intravenous push,d1; 2400mg/m2 continuous intravenous infusion for 46 hours
~repeat every 2 weeks"
16225941|NCT01193426|Other|Ascite liquid puncture|Ascitic fluid obtained by paracentesis
16225942|NCT01193400|Drug|Clofarabine|
16225943|NCT01193400|Drug|Cytarabine|
16225944|NCT01193387|Drug|insulin degludec|Each subject will be allocated to 2 single doses of trial product on 2 separate visits: One injection with formulation 1 and and one injection with formulation 2). Injected subcutaneously (under the skin).
16225945|NCT01193387|Drug|insulin degludec|Each subject will be allocated to 2 single doses of trial product on 2 separate visits: One injection with formulation 1 and and one injection with formulation 2). Injected subcutaneously (under the skin).
16225946|NCT01193374|Behavioral|Clinician enhanced screening and counseling prompts|PDA based health risk screening for well child issues and obesity risks
16225947|NCT01193374|Behavioral|Tailored education and motivational materials|Specific tailoring for those interested in change vs not . Two newsletters over 3 mpn.
16225948|NCT01193374|Behavioral|basic educational brochure|Booklet by ADA sent x 1.
16225949|NCT01193361|Drug|BMS-791325|Tablets, Oral, 75 mg, twice daily, 4-48 weeks depending on response
16225950|NCT01193361|Drug|BMS-791325|Tablets, Oral, 150 mg, twice daily, 4-48 weeks depending on response
16225951|NCT01193361|Drug|Placebo|Tablets, Oral, 0 mg, twice daily, 4-48 weeks depending on response
16225952|NCT01193361|Drug|Peg-interferon alfa-2a|Syringe, Subcutaneous Injection, 180 µg, once weekly, 4-48 weeks depending on response
16225953|NCT01193361|Drug|Ribavirin|Tablets, Oral, 1000 or 1200 mg based on weight, twice daily, 4-48 weeks depending on response
16225954|NCT01193348|Drug|Eculizumab|Fixed dosing is based on body weight cohorts. Adjustment of dose to accommodate patient growth is possible.
16225955|NCT01193335|Biological|13-valent pneumococcal conjugate vaccine|13-valent pneumococcal conjugate vaccine will be administered at 2, 3, 4 and 12 months of age.
16225956|NCT01193335|Biological|13-valent pneumococcal conjugate vaccine|13-valent pneumococcal conjugate vaccine will be administered at 2, 3, 4 and 12 months of age.
16225957|NCT01193296|Drug|Vildagliptin|
16225958|NCT01193296|Drug|Sitagliptin|
16225959|NCT01193283|Drug|Cyclophosphamide|30 my/kg for 4 days
16225960|NCT01193283|Drug|Cyclosporine|daily to a trough of 100 t0 200 ng/ml
16225961|NCT01193270|Drug|Vitamin E|A single intragastric dose of dl-α-tocopheryl acetate 50 IU/kg.
16225962|NCT01193270|Drug|Placebo|Sterile water in volume equal to that of the comparator drug
16225963|NCT01193257|Drug|Orteronel|Orteronel tablets
16225966|NCT01193244|Drug|Orteronel|Orteronel will be administered orally twice a day continuously throughout the study. Patients will also receive concomitant gonadotropin-releasing hormone (GnRH) analogue therapy unless they have previously undergone orchiectomy and have a testosterone concentration of <50 ng/dL.
16225967|NCT01193244|Drug|Placebo|Placebo will be administered orally twice a day continuously throughout the study. Additionally, all patients will receive concomitant gonadotropin-releasing hormone (GnRH) analogue therapy unless they have previously undergone orchiectomy and a testosterone concentration of <50 ng/dL.
16225968|NCT01193244|Drug|Prednisone|Prednisone will be administered orally twice a day continuously throughout the study. Patients will also receive concomitant gonadotropin-releasing hormone (GnRH) analogue therapy unless they have previously undergone orchiectomy and have a testosterone concentration of <50 ng/dL.
16225969|NCT01193218|Drug|Placebo (low dose)|Placebo tablets once a day
16225970|NCT01193218|Drug|Placebo (low dose)|Placebo tablets once a day
16225971|NCT01193218|Drug|Placebo (mid dose)|Placebo tablets once a day
16225972|NCT01193218|Drug|Placebo (high dose)|Placebo tablets once a day
16225973|NCT01193218|Drug|BI 10773|BI 10773 tablets low dose once a day
16225974|NCT01193218|Drug|Placebo (mid dose)|Placebo tablets once a day
16225975|NCT01193218|Drug|Placebo (high dose)|Placebo tablets once a day
16225976|NCT01193218|Drug|Placebo (high dose)|Placebo tablets once a day
16225977|NCT01193218|Drug|BI 10773|BI 10773 tablets mid-high dose once a day
16225978|NCT01193218|Drug|BI 10773|BI 10773 tablets high dose once a day
16225979|NCT01193218|Drug|Placebo (mid dose)|Placebo tablets once a day
16225980|NCT01193218|Drug|Placebo (high dose)|Placebo tablets once a day
16225981|NCT01193218|Drug|Placebo (low dose)|Placebo tablets once a day
16225982|NCT01193218|Drug|Placebo (low dose)|Placebo tablets once a day
16225983|NCT01193218|Drug|BI 10773|BI 10773 tablets mid-low dose once a day
16225984|NCT01193218|Drug|Placebo (mid dose)|Placebo tablets once a day
16225985|NCT01193205|Behavioral|Skills Training|20 weeks of Dialectical Behaviour Therapy Skills Training
16225986|NCT01193192|Other|Neevo®|"A prenatal medical food - analogous to a prenatal vitamin but containing L-methylfolate in addition to folic acid"
16225987|NCT01193192|Other|Prenatal vitamins|for inclusion in the Control Group, prenatal vitamins must have contained ≤1mg folic acid, 27 - 35mg iron, and ≤12mcg vitamin B12.
16225988|NCT01193179|Drug|OPC-262|Oral administration of tablets for 52 weeks
16225989|NCT01193166|Drug|paliperidone palmitate|78, 117, 156, or 234 mg monthly injection for 12 months
16225990|NCT01193166|Drug|risperidone|flexible dosing as prescribed by the study doctor for 12 months
16225991|NCT01193166|Drug|olanzapine|flexible dosing as prescribed by the study doctor for 12 months
16225992|NCT01193166|Drug|aripiprazole|flexible dosing as prescribed by the study doctor for 12 months
16225993|NCT01193166|Drug|haloperidole|flexible dosing as prescribed by the study doctor for 12 months
16225994|NCT01193166|Drug|quetiapine|flexible dosing as prescribed by the study doctor for 12 months
16225995|NCT01193166|Drug|perphenazine|flexible dosing as prescribed by the study doctor for 12 months
16225996|NCT01193166|Drug|paliperidone|flexible dosing as prescribed by the study doctor for 12 months
16225997|NCT01193153|Drug|Placebo|monthly by i.m. injection for 15 months
16225998|NCT01193153|Drug|paliperidone palmitate|78, 117, 156, 234 mg (50, 75, 100, or 150 mg eq.) monthly by i.m. injection for 15 months
16225999|NCT01193140|Drug|veliparib|Dose orally twice daily for 7 days, consecutively, every cycle
16226000|NCT01193140|Drug|Temozolomide|Dose orally once daily for 5 days, consecutively, every cycle
16226001|NCT01193127|Drug|OMS302 Solution|
16226002|NCT01193127|Drug|OMS302 Mydriatic Solution|
16226003|NCT01193127|Drug|OMS302 Anti-inflammatory Solution|
16226004|NCT01193127|Drug|Balanced Salt Solution (BSS) Solution|
16226005|NCT01193114|Behavioral|Ecologically Based Treatment (EBT)|Substance abuse treatment (the Community Reinforcement Approach), case management and housing.
16226006|NCT01193114|Behavioral|Treatment as Usual (TAU)|Treatment/intervention as normally provided by community service agencies that service substance abusing homeless families.
16226007|NCT01193101|Drug|LCZ696|LCZ696
16226008|NCT01193101|Drug|Placebo|matching placebo to LCZ696
16226009|NCT01193062|Drug|PF-04995274|Subjects will be randomized to receive single oral doses of 0.1 mg, 10 mg, 15mg/ 40 mg PF-04995274 or a placebo
16226010|NCT01193062|Drug|PF-04995274|Doses for cohort 2 will be decided based on an Interim analysis of data from cohort 1. The highest dose to be used in Cohort 2 not to exceed 15mg
16226011|NCT01193049|Drug|Prednisone|Prednisone (25 mg) tablets as a single oral dose on Day 1 of each study period
16226012|NCT01193049|Drug|Placebo|Matching placebo tablets as a single oral dose on Day 1 of each study period
16226013|NCT01193036|Behavioral|Part 1: Interview + Questionnaires|Questionnaires to be completed immediately after interview, which will take approximately 15 minutes.
16226014|NCT01193036|Behavioral|Part 2: Multiple Questionnaires|Questionnaires to be repeated about every 2 weeks for 1 year.
16226015|NCT01193023|Other|Pressure Support|Ventilation under pressure support
16226016|NCT01193023|Device|NAVA|Ventilation under NAVA
16226017|NCT01193010|Procedure|Computer-Assisted Surgical Planning|Using a CT reconstructing of affected distal radius and the normal contralateral limb, surgical guides for the osteotomy will be created to assist with surgical planning.
16226018|NCT01193010|Procedure|distal radius osteotomy|In this control group, the planning and surgical execution of the distal radius osteotomy will be performed as usual, without computer-assisted planning of the osteotomy.
16226019|NCT01192997|Biological|Menveo|Single dose Menveo (a MenACWY vaccine conjugated to CRM-197).
16226020|NCT01192997|Biological|MenACWY-TT|Single dose MenACWY-TT (MenACWY vaccine conjugated to Tetanus Toxoid, TT)
16226021|NCT01192984|Biological|KW-0761|Intravenously 8 times at 1-week intervals
16226022|NCT01192971|Drug|Apatinib|apatinib p.o. once daily for 4 weeks
16226073|NCT01192607|Device|Endoscopic treatment during root canal treatment|Endoscopic treatment during root canal treatment
16226023|NCT01192932|Radiation|Chest CT scan|"Supine CT scan after full inspiration. Acquisition parameters: (Topogram 35 mA 120 kV 512 mm length)
~90 quality ref mAs with care-dose ON
~120 kV
~Pitch 1.4
~Rotation time 0.33 s
~Acquired images 64 x 0.6 mm"
16226024|NCT01192906|Drug|Placebo|Oral doses, once a day for 52 weeks
16226025|NCT01192906|Drug|bitopertin [RO4917838]|Oral dose level 1, once a day for 52 weeks
16226026|NCT01192906|Drug|bitopertin [RO4917838]|Oral dose level 2, once a day for 52 weeks
16226027|NCT01192880|Drug|Placebo|Participants will receive bitopertin matching placebo once daily for 56 weeks.
16226028|NCT01192880|Drug|Bitopertin|Participants will receive 10 mg or 20 mg of bitopertin.
16226029|NCT01192880|Drug|Antipsychotics|Participants will continue to receive their stable antipsychotic regiment throughout the study. Study protocol does not specify any particular antipsychotic drug and regimen.
16226030|NCT01192867|Drug|Placebo|Placebo will be administered orally QD for 56 weeks
16226031|NCT01192867|Drug|RO4917838|RO4917838 will be administered orally at 20 or 10 mg QD for 56 weeks.
16226032|NCT01192867|Drug|Antipshychotics (Standard of Care)|Participants will continue to receive their stable antipshychotic as standard of care based on their prescription up to Week 56.
16226033|NCT01192854|Drug|Clevudine|Clevudine flexible dosages of 30 mg/day
16226034|NCT01192854|Drug|Adefovir|Adefovir flexible dosages of 10 mg/day
16226035|NCT01192841|Other|Physician uniform|Participants were given a clean uniform (scrubs) on the day of the study. They wore this for approximately 8 hours.
16226036|NCT01192828|Drug|taurine|Take Taurine for 4 1/2 days, two doses per day
16226037|NCT01192815|Drug|erlotinib hydrochloride|Given orally or via gastronomy tube
16226038|NCT01192815|Radiation|intensity-modulated radiation therapy|IMRT will be given in 35 fractions over 7 weeks. The primary tumor and involved nodes (PTV70) will receive 2 Gy per fractions, intermediate-risk areas (PTV63) will receive 1.8 Gy per fractions, and subclinical disease sites (PTV56) will receive 1.6 Gy perfraction. The total doses will thus be 70 Gy, 63 Gy and 56 Gy, respectively.
16226039|NCT01192815|Other|pharmacogenomic studies|Optional correlative studies
16226040|NCT01192815|Other|gene expression analysis|Correlative studies
16226041|NCT01192815|Radiation|3-dimensional conformal radiation therapy|"The initial target volume encompassing the gross and subclinical disease sites will receive 2.0 Gy per fraction, five fractions a week to 54 Gy in 27 fractions in 5.4 weeks. The boost volume covering gross tumor and clinically/radiologically involved nodes will receive boost irradiation for additional 16 Gy at 2.0 Gy. The primary tumor and clinically/radiologically-involved nodes will thus receive 70 Gy in 35 fractions over 7 weeks, and uninvolved upper neck nodes will receive an elective dose of 54 Gy in 5.4 weeks.
~The uninvolved lower neck nodes will receive 2.0 Gy per fraction at 3-cm depth to a total dose of 50 Gy in 25 fractions in 5.0 weeks through a matching AP or AP/PA lower neck field."
16226042|NCT01192815|Other|biopsy|Optional correlative studies
16226043|NCT01192815|Other|pharmacological study|Optional correlative studies
16226044|NCT01192815|Other|laboratory biomarker analysis|Optional correlative studies
16226045|NCT01192815|Other|questionnaire administration|Optional ancillary studies
16226046|NCT01192815|Other|enzyme-linked immunosorbent assay|Optional correlative studies
16226047|NCT01192815|Other|polymorphism analysis|Optional correlative studies
16226048|NCT01192802|Drug|albendazole|1 tablet of 400 mg of albendazole per day for three consecutive days
16226049|NCT01192802|Drug|albendazole|single 1 tablet of 400 mg of albendazole
16226050|NCT01192802|Drug|albendazole|1 tablet of 400 mg of albendazole per day for two consecutive days
16226051|NCT01192789|Drug|Amoxicillin|LHWs treat severe pneumonia with oral amoxicillin at 90 mg/kg/day.
16226052|NCT01192789|Other|Referral to Health facility|LHWs refer the severe pneumonia case to local health facility or private practitioner. In case of refused referral , treat the case with oral cotrimoxazole for 7 days.
16226053|NCT01192776|Procedure|Whole-body Cooling|Whole-body cooling using a Blanketrol II or III to reach either a target core temperature of 33.5°C or 32.0°C for a duration of either 72 hours or 120 hours.
16226054|NCT01192763|Drug|gamma-secretase/Notch signalling pathway inhibitor RO4929097|Given orally
16226055|NCT01192763|Other|laboratory biomarker analysis|Correlative studies
16226056|NCT01192763|Other|pharmacological study|Correlative studies
16226057|NCT01192763|Procedure|neoadjuvant therapy|
16226058|NCT01192763|Procedure|therapeutic conventional surgery|
16226059|NCT01192750|Other|immunohistochemistry staining method|
16226060|NCT01192750|Other|laboratory biomarker analysis|
16226061|NCT01192750|Other|medical chart review|
16226062|NCT01192724|Drug|Cilostazol|100 mg BID, for 3 months
16226063|NCT01192724|Drug|Aspirin|Aspirin 100 mg QD, for 1 year
16226064|NCT01192724|Drug|Clopidogrel|Clopidogrel 75 mg QD, for 1 year
16226065|NCT01192711|Device|Diabetes Interactive Diary (DID)|DID is both a CHO/insulin bolus calculator, an information technology and a telemedicine system based on the communication between health care professional (physician or dietitian) and patient by SMS messages.
16226066|NCT01192698|Drug|IV interferon|IV interferon 5MU during anhepatic phase
16226067|NCT01192685|Procedure|Transcranial Magnetic Stimulation (TMS)|TMS will be administered to subjects 5 days a week-typically Monday through Friday, for 6 weeks.
16226068|NCT01192685|Device|near infrared spectroscopy (NIRS)|near infrared spectroscopy (NIRS) will be used to measure the blood flow in the brain
16226069|NCT01192672|Behavioral|Expressive Writing|Subjects in the Intervention were instructed to write for 30-minute intervals for 4 consecutive days about their deepest thoughts and feelings related to their Irritable Bowel Syndrome.
16226070|NCT01192672|Behavioral|Control Writing|Subjects were asked to write about the actions they performed during the last 24 hours. They were asked not to write about their feelings or thoughts related to these actions.
16226071|NCT01192646|Behavioral|HBLSS|Home Based life saving skills training will be done in the intervention cluster while in the control group no training
16226072|NCT01192633|Drug|GVP|"Drug: gemcitabine, vincristine,cisplatin
~cisplatin 25mg/m2，ivgtt，D1, 2, 3 gemcitabine 1000mg/m2，ivgtt，30'，D1, 8 vincristine 1.4mg/m2(less than 2 mg), iv, D1 repeat every 3 weeks"
16226205|NCT01191632|Radiation|No Radiation|Control group with 0Gy
16226074|NCT01192594|Behavioral|Training in all modules including MAPP Recovery Model|50% of the case managers will complete all five modules: Disease state,psychopharmacology,symptom management, motivational interviewing and adherence, and the Milestones of Adjustment Post-Psychosis Recovery Model including the MAPP treatment guide.
16226075|NCT01192594|Behavioral|Training in all modules except MAPP Recovery Model|50% of the case managers in the study will complete only four training modules: Disease state, psychopharmacology, symptom management, and motivational interviewing and adherence. They will not complete the Milestones of Adjustment Post-Psychosis Recovery Model module.
16226076|NCT01192581|Drug|hydroxyethyl starch 130/0.4 and sodium chloride injection|routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 500mg
16226077|NCT01192581|Drug|hydroxyethyl starch 130/0.4 and sodium chloride injection|routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1000mg
16226078|NCT01192581|Drug|hydroxyethyl starch 130/0.4 and sodium chloride injection|routine treatment for brain hypoperfusion plus hydroxyethyl starch 130/0.4 and sodium chloride injection 1500mg
16226079|NCT01192568|Drug|Oxybutynin|10% Oxybutynin Chloride Topical Gel, 0.5 g, 0.75 g, and 1 g/day, administered transdermally.
16226080|NCT01192555|Biological|Neuroblastoma Vaccine (unmodified SKNLP, with gene-modified SJNB-JF-IL2 and SJNB-JF-LTN neuroblastoma cells|"1x10^7cells/m2 each of unmodified SKNLP, with gene-modified SJNB-JF-IL2 and SJNB-JF-LTN neuroblastoma cells will be given by subcutaneous injection while suspended in Ringers solution with 5% HSA in a single syringe in a volume of up to 1 ml.
~Vaccines will be given on day 0 of week 0 and then on day 0 (+ 72 hours) of weeks 2, 4, 6, 9, 12, 16, 20.
~Cells will be administered as a subcutaneous injection over 1 minute using a 21-gauge needle. Procedural pain control methods may be used per institutional protocol."
16226081|NCT01192555|Drug|Cytoxan|Metronomic oral cytoxan will start 72 hours prior to the first vaccination at a dose of 50 mg/m2/day. Cytoxan will be held on the day of vaccine administration and for the next 96 hours. After the first vaccine, patients will take 25 mg/m2/day as outlined on the roadmap.
16226082|NCT01192542|Device|galyfilcon A prototype lens|Prototype silicone hydrogel contact lens
16226083|NCT01192542|Device|enfilcon A lens|Marketed silicone hydrogel contact lens
16226084|NCT01192529|Dietary Supplement|Supressi. T-Diet plus Range|"Supressi is a complete high protein and moderated high energy oral nutrition supplement, indicated for the dietary management of patients with neurodegenerative diseases and related malnutrition.
~Experimental group patients will receive, 2 packs per day (Tetra brik aseptic)of 200 ml for 6 months."
16226085|NCT01192529|Dietary Supplement|High Protein. T-Diet plus Range|T-Diet plus High Protein is a complete high protein and moderated high energy oral nutrition supplement, indicated for the dietary management of patient with related malnutrition and with increased protein requirements.
16226086|NCT01192516|Behavioral|Tailored Activity Pacing|Therapeutic intervention will be based on a tailored approach using collected data on symptom and activity patterns of each participant.
16226087|NCT01192516|Behavioral|General Activity Pacing|Therapeutic intervention using generalized pacing instruction to manage symptoms
16226088|NCT01192503|Drug|rasagiline|1mg (2 tablets of 0.5mg) at bedtime taken by mouth for 12 weeks
16226089|NCT01192503|Drug|placebo (sugar pill)|1mg (2 tablets of 0.5mg) taken at bedtime by mouth for 12 weeks
16226090|NCT01192490|Drug|Lidocaine|5cc of 2% Lidocaine gel will be placed on the cervix and intra-cervically prior to placement of a Mirena
16226091|NCT01192490|Drug|Lubricant|KY Gel will be placed on the cervix and intra-cervically prior to placement of the Mirena
16226092|NCT01192477|Other|Ozone|All subjects will have a 3-hour exposure to clean air, a 3-hour exposure to clean air with lower ozone (0.1 ppm), and a 3-hour exposure to clean air with higher ozone (0.2 ppm). Exposures will take place at least 3 weeks apart. Order of exposure will be randomized for each subject.
16226093|NCT01192464|Drug|autologous CAR.CD30 EBV specific-CTLs|Three dose levels will be evaluated. Using the modified continual reassessment method, cohorts of size two will be enrolled at each dose level. Each patient will receive one injection.
16226094|NCT01192438|Procedure|Laser-based thermotherapy|MRI-guided transperineal placement of a laser probe into the prostate
16226095|NCT01192412|Procedure|Intervention is blood pressure management approach|1) 'Less tight' control. The dBP treatment goal is 100 mmHg. For safety, if dBP is >105 mmHg, then antihypertensive medication must be started or increased in dose. For dBP <100 mmHg, antihypertensive therapy should be decreased in dose or stopped, as appropriate. The intervention will be applied until delivery.
16226096|NCT01192412|Procedure|Intervention is blood pressure management approach.|'Tight' control. The dBP treatment goal is 85 mmHg. For safety, if dBP is <80 mmHg, then antihypertensive medication must be decreased in dose or discontinued. If dBP is >85 mmHg, then antihypertensive therapy should be started or increased in dose. The intervention will be applied until delivery.
16226097|NCT01192399|Biological|Eculizumab|
16226098|NCT01192373|Other|Metabolic substrate modulation|for high circulation free fatty acids: Heparin (250IE/hour) + intralipid (20%, 62 ml/hour).
16226099|NCT01192373|Other|metabolic substrate modulation|low circulating free acids: hyperinsulinaemic euglycemic clamp (0,8 mUkg/min) with venous blood glucose at 4,5-6,5 mM.
16226100|NCT01192360|Procedure|Phase contrast flow velocity mapping (PC)|An MRI is done using the phase contrast flow velocity mapping (PC)technique. Using PC, an imaging slice is prescribed perpendicular to the vessel's course. Within the pulmonary circulation, PC can quantify total pulmonary blood flow and the right / left distribution of the lung blood flow volume.
16226101|NCT01192360|Procedure|Dynamic contrast-enhanced magnetic resonance imaging|Dynamic contrast-enhanced magnetic resonance (DCE MR) perfusion imaging imaging is a non-invasive method to quantify regional pulmonary blood flow. A bolus of gadolinium-containing contrast medium is injected and its passage through the pulmonary circulation traced using a repetitive rapid three-dimensional (3D) T1 weighted angiography sequence.
16226102|NCT01192321|Device|Toric T3 - T9|Bilateral implantation of Alcon AcrySof Toric Intraocular Lens (IOL) models SN60T3 through SN60T9 following cataract removal.
16226103|NCT01192321|Device|Monofocal|Bilateral implantation of any monofocal Intraocular Lens (IOL) following cataract removal.
16226104|NCT01192308|Drug|Tamoxifen 40mg QD|Tamoxifen 40mg QD during 4 weeks
16226105|NCT01192295|Drug|Oxycodone HCl controlled-release tablets|Oxycodone HCl controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg - 240 mg daily) every 12 hours.
16226106|NCT01192282|Procedure|Medical / Surgical Treatment|All participants received treatment based on the morphology and distributions of lesions. For the treatment with Trichloroacetic Acid (TCA), patients were advised to attend the clinic weekly until no visible lesions seen. For electrosurgery or laser, patients were given a date for admission a day prior to surgery. Post-operatively, she remained in the ward for at least five days.
16226107|NCT01192269|Dietary Supplement|DHA (docosahexaenoic acid)|1 x 950 mg capsules per day orally, each capsule providing ~520 mg of DHA as a triglyceride. The liquid fill contains DHASCO® oil, derived from the microalgae, Schizochytrium sp., high-oleic sunflower oil, natural mixed tocopherols, ascorbyl palmitate, and rosemary extract (flavouring). The gelatin shell contains glycerin, water, and colouring (carmel, carmine, turmeric).
16226108|NCT01192243|Drug|Gefitinib|250mg qd po d3-16
16226109|NCT01192243|Drug|Pemetrexed|500mg/m2 venous infusion,D1,q3w
16226110|NCT01192243|Drug|Cisplatin or carboplatin|Cisplatin:75mg/m2, venous infusion,D1,q3w or Carboplatin: AUC 5, venous infusion, D1,q3w
16226111|NCT01192230|Drug|Endostatins|7.5mg/m2 qd *14d,q3w
16226112|NCT01192230|Drug|Docetaxel|75mg/m2 D1, q3w,4-6cycles
16226113|NCT01192217|Procedure|Modified thoracoscopic technique|Two-port thoracoscopic technique
16226114|NCT01192217|Procedure|Axillary mini-thoracotomy|Axillary mini-thoracotomy
16226115|NCT01192204|Drug|10% FBR containing bioadhesive gel|0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months
16226116|NCT01192204|Drug|placebo gel|0.5 gm applied 4 times daily to the oral premalignant lesion site for a duration of 3 months
16226117|NCT01192191|Drug|Fluticasone Furoate/GW642444 Inhalation Powder 100/25mcg|Fluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks
16226118|NCT01192191|Drug|Fluticasone Furoate/GW642444 Inhalation Powder 200/25mcg|Fluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks
16226119|NCT01192178|Drug|FLOVENT™ DISKUS™ 100 mcg BID|FLOVENT™ DISKUS™ 100 mcg, one inhalation twice daily (BID) from the DISKUS device from randomization through the end of study (week 16).
16226120|NCT01192178|Drug|ADVAIR™ DISKUS™ 100/50 mcg BID|ADVAIR™ DISKUS™ 100/50 mcg is a combination product containing a 100 mcg fluticasone propionate and a 50 mcg salmeterol. One inhalation from the DISKUS device twice daily (BID) from randomization through end of study (week 16).
16226121|NCT01192165|Drug|Trametinib (GSK1120212)|Investigational small molecule targeted therapy (MEK1/2 inhibitor)
16226122|NCT01192165|Drug|Docetaxel|Chemotherapy
16226123|NCT01192165|Drug|Erlotinib|Small molecule targeted therapy (EGFR inhibitor)
16226124|NCT01192165|Drug|Pemetrexed|Chemotherapy
16226125|NCT01192165|Drug|Carboplatin|Chemotherapy
16226126|NCT01192165|Drug|nab-Paclitaxel|Chemotherapy
16226127|NCT01192165|Drug|Cisplatin|Chemotherapy
16226128|NCT01192152|Drug|saxagliptin|Tablets, Oral, 5 mg, once daily, Single dose
16226129|NCT01192152|Drug|Glucophage XR|Tablets, Oral, 500 mg, once daily, Single dose
16226130|NCT01192152|Drug|saxagliptin + metformin XR (FDC tablet)|Tablet, Oral, (saxagliptin 5 mg)(metformin XR 1000 mg), once daily, 4 days
16226131|NCT01192139|Drug|saxagliptin|Tablets, Oral, 5 mg, once daily, Single dose
16226132|NCT01192139|Drug|metformin XR|Tablets, Oral, 500 mg. once daily, Single dose
16226133|NCT01192139|Drug|saxagliptin + metformin XR (FDC tablet)|Tablet, Oral, (saxagliptin 5 mg)(metformin XR 500 mg), once daily, Single dose
16226134|NCT01192126|Device|Bausch & Lomb new daily disposable|Test lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis.
16226135|NCT01192126|Device|Johnson & Johnson Acuvue Moist|Control lenses are to be worn for approximately one week. Lenses will be worn on a daily wear basis.
16226136|NCT01192113|Drug|Mecobalamin IV Injection|Mecobalamin injection 0.5 mg/ ml administered as an intravenous (IV) injection 3 times a week for four weeks
16226137|NCT01192113|Drug|Mecobalamin IM injection|Mecobalamin injection 0.5 mg/ ml administered as an intramuscular (IM) injection 3 times a week for four weeks
16226138|NCT01192113|Drug|Mecobalamin IV or IM injection|Mecobalamin injection 0.5 mg/ ml administered as an IM or IV injection 3 times a week for four weeks
16226139|NCT01192100|Behavioral|Breakfast Skipping|Participants will continue to skip breakfast each morning.
16226140|NCT01192100|Behavioral|Normal Protein Breakfast Meals|Participants will consume normal protein breakfast meals each morning.
16226141|NCT01192100|Behavioral|Protein-rich Breakfast Meals|Participants will consume protein-rich breakfast meals each morning.
16226142|NCT01192087|Drug|Cetuximab|cetuximab initial dose (7 days prior to RT treatment start): 400 mg/m² body surface cetuximab weekly doses (from RT treatment start throughout radiation treatment): 250 mg/m² body surface
16226143|NCT01192074|Device|Ultrasound|Preprocedure ultrasound examination of the spine
16226144|NCT01192048|Other|Blood Sample Collection|Blood sample collection for direct sequencing, microarray, single nucleotide polymorphism, whole-genome array comparative genomic hybridization DNA analyses, and/or whole exome sequencing.
16226145|NCT01192035|Drug|Efavirenz or Nevirapine|"2 NRTIs (lamivudine 150 mg bis in die - twice a day (BID) and either zidovudine 300 mg BID if hemoglobin is ≥ 8 g/L or stavudine 30 mg BID if hemoglobin is < 8 g/L) and 1 NNRTI (efavirenz 600 mg omne in die - once daily (OD) or nevirapine 200 mg OD for the first 2 weeks and after that 200 mg BID). Efavirenz will be used in all male patients according to national HIV guidelines. Pregnant patients and female patients with a child bearing potential will be treated with nevirapine if CD4+ cell count is ≤ 350 cells/mm3 with close monitoring of liver enzymes during the first 12 weeks in patients with CD4+ cell count >250 cells/mm3. Females beyond childbearing age will be treated with efavirenz."
16226146|NCT01192035|Drug|Ritonavir-boosted lopinavir|2 NRTIs (lamivudine 150 mg BID and either zidovudine 300 mg BID if hemoglobin is ≥ 8 g/L or stavudine 30 mg BID if hemoglobin is < 8 g/L) and 1 PI (ritonavir-boosted lopinavir 400/100 mg BID).
16226147|NCT01192022|Biological|TachoSil®|Intraoperative application as secondary hemostatic treatment
16226148|NCT01192022|Device|Surgicel® Original|Intraoperative application as secondary hemostatic treatment
16226149|NCT01192009|Dietary Supplement|Leucine|7.2 g of leucine during 2 weeks
16226150|NCT01192009|Dietary Supplement|Placebo|7.2 g of alanine during 2 weeks
16226151|NCT01191996|Biological|MIS416|MIS416 intravenously every week
16226152|NCT01191983|Drug|Methoxy polyethylene glycol-epoetin beta [Mircera]|Starting dose of 1.2 mcg/kg, adjusted according to Hb values, administered by subcutaneous injection Q4W
16226153|NCT01191957|Drug|Busulphan plus Cyclophosphamide|"I.V. Bu (Busilvex), 12.8 mg/kg:
~Day -9: 0.8 mg/kg/dose x 4 doses Day -8: 0.8 mg/kg/dose x 4 doses Day -7: 0.8 mg/kg/dose x 4 doses Day -6: 0.8 mg/kg/dose x 4 doses Day -5: Rest
~Followed by:
~Cyclophosphamide, 120 mg/kg iv:
~Day -4: 60 mg/kg Day -3: 60 mg/kg"
16226154|NCT01191957|Drug|Busulphan plus Fludarabine|"I.V. Bu (Busilvex), 12.8 mg/kg:
~Day -6: 0.8 mg/kg/dose x 4 doses Day -5: 0.8 mg/kg/dose x 4 doses Day -4: 0.8 mg/kg/dose x 4 doses Day -3: 0.8 mg/kg/dose x 4 doses plus:
~Fludarabine, 4 x 40 mg/m² iv:
~Day -6: 40 mg/m² Day -5: 40 mg/m² Day -4: 40 mg/m² Day -3: 40 mg/m²"
16226155|NCT01191944|Drug|pramipexole immediate release tablet|0.375mg-4.5mg(daily dose), three times a day
16226156|NCT01191944|Drug|pramipexole extended release tablet|0.375mg-4.5mg, once a day
16226157|NCT01191918|Drug|Donepezil and Lithium|Donepezil dose will be started at 5mg/d and increased to 10 mg/d in 1 week.
16226158|NCT01191918|Drug|Placebo plus Lithium|
16226159|NCT01191905|Drug|high dose CRRT|clearance of 80 mL/Kg/hr (1:1 balanced pre-dilution CVVHDF)
16226160|NCT01191905|Drug|Conventional dose CRRT|clearance of 40 mL/Kg/hr (1:1 balanced pre-dilution CVVHDF)
16226161|NCT01191892|Drug|carboplatin|
16226162|NCT01191892|Drug|gemcitabine hydrochloride|
16226163|NCT01191892|Drug|vandetanib|
16226164|NCT01191892|Drug|Placebo|Placebo of vandetanib tablet
16226165|NCT01191879|Other|Blood test|Blood test
16226166|NCT01191866|Behavioral|psychosocial intervention|The interventions will include an art therapist, a social worker and volunteer work under the supervision of a diabetes nurse. These therapies will be given to selected patients based on individual needs. We will use existing questionnaires in order to identify problematic areas and quantify quality of life
16226167|NCT01191840|Drug|Vancomycin|Duration
16226168|NCT01191840|Drug|Vancomycin|Duration
16226169|NCT01191814|Procedure|Metal stent|Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a metal stent.
16226170|NCT01191814|Procedure|Plastic stent|Patients with pancreatic cancer causing bile duct obstruction will be treated by placement of a 10Fr plastic stent.
16226171|NCT01191801|Drug|vosaroxin + cytarabine|"Vosaroxin days 1 and 4: 90 mg/m2 for induction 1; 70 mg/m2 for all other cycles
~Cytarabine 1 g/m2 daily on days 1-5 (IDAC)"
16226172|NCT01191801|Drug|placebo + cytarabine|"Placebo days 1 and 4: volume matched to vosaroxin
~Cytarabine 1 g/m2 daily on days 1-5 (IDAC)"
16226173|NCT01191788|Behavioral|Group Cognitive Behavioral Therapy|16 two hour sessions of group CBT
16226174|NCT01191788|Behavioral|Group CBT for Depression|16 of group CBT for depression delivered in 2 hour groups for up to 8 weeks by a trained substance abuse treatment counselor
16226175|NCT01191775|Drug|PNT2258|Patients will receive PNT2258 as an intravenous infusion once daily for 5 consecutive days (Days 1-5) of every 21-day cycle (3 weeks). The treatment cycle repeats every 3 weeks for up to 6 cycles in the absence of disease progression, unacceptable toxicity, or patient withdrawal from the study.
16226176|NCT01191762|Drug|sevelamer carbonate|2400 mg with each meal for 4 weeks
16226177|NCT01191762|Drug|placebo|3 tablets with each meal
16226178|NCT01191749|Drug|Alemtuzumab|10 mg by vein over 2 hours on Days 1 to 10 of a 28 day cycle.
16226179|NCT01191736|Behavioral|No training, assessed within 60 mins|Subjects receive no training in resuscitation
16226180|NCT01191736|Behavioral|Ultra-brief video; assessed in 60 mins|Subjects receive an ultra-brief (90-second) video on hands-only CPR
16226181|NCT01191736|Behavioral|Brief video; assessed in 60 mins|Subjects receive a brief (5-minute) video on hands-only CPR
16226182|NCT01191736|Behavioral|Brief video + hands-on; ass'd in 60 mins|Subjects receive a brief (5-minute) video with hands-on manikin practice
16226183|NCT01191736|Behavioral|Ultra-brief video; assessed at 2 months|Subjects see ultra-brief video (90-seconds), are assessed two months later
16226184|NCT01191736|Behavioral|Brief video; assessed 2 months later|Subjects see brief video (5 minutes), are then assessed two months later
16226185|NCT01191736|Behavioral|Brief video + hands-on; ass'd 2 ms later|Subjects see brief (5-minute) video, receive hands-on training, and are assessed two months later
16226186|NCT01191723|Drug|MAP0004|3.0mg orally inhaled MAP0004 administered in Treatment B as per protocol
16226187|NCT01191723|Drug|Inhaler Placebo|Placebo for Inhaler administered in Treatments A and C
16226188|NCT01191723|Drug|Moxifloxacin|400mg encapsulated tablet administered in Treatment A as per protocol
16226189|NCT01191723|Drug|Placebo Capsule|Placebo for Moxifloxacin administered in Treatment B and Treatment C
16226190|NCT01191710|Other|In vitro fertilization|In vitro fertilization procedure with gonadotropin induced follicular ovarian stimulation
16226191|NCT01191697|Drug|bevacizumab|Given intravenously on day 1 of each cycle beginning cycle 2
16226192|NCT01191697|Drug|trastuzumab|Given intravenously on day 1 of each treatment cycle
16226193|NCT01191697|Drug|oxaliplatin|Given intravenously on day one of each cycle beginning cycle 2
16226194|NCT01191697|Drug|capecitabine|Taken orally on days 1-14 of each cycle beginning cycle 2
16226195|NCT01191684|Other|laboratory biomarker analysis|Correlative studies
16226196|NCT01191684|Other|enzyme-linked immunosorbent assay|Correlative studies
16226197|NCT01191684|Other|flow cytometry|Correlative studies
16226198|NCT01191684|Other|immunoenzyme technique|Correlative studies
16226199|NCT01191684|Biological|modified vaccinia virus ankara vaccine expressing p53|Given SC
16226200|NCT01191645|Drug|naloxone|Injection fluid, solution 0,4 mg/kg Bolus infusion 6ug/kg at one occasion Continuous infusion 0,1 ug/kg/minute during 50 min
16226201|NCT01191645|Drug|remifentanil|Powder for injection/ infusion fluid solution, 2 mg Infusion TCI 1ng/kg 10 min ( 0,05 ug/kg/min) Infusion TCI 2ng/kg 10 min ( 0.10 ug/kg/min) Infusion TCI 3ng/kg 20 min ( 0,15 ug/kg/min)
16226202|NCT01191645|Drug|Sodium Chloride|Infusion fluid, solution 9 mg/ml ( hydrogenic solution )
16226203|NCT01191645|Drug|metoclopramide|Injection fluid, solution 5 mg/mg Iv injection 0,2 mg/kg at one occasion
16226204|NCT01191632|Radiation|one time radiation|"Radiation: one time Radiation with an intensity of
~0.5 Gy Group A 2.0 Gy Group B 5 Gy Group C Beginning on a weekday 48 hours before surgery"
16226206|NCT01191619|Procedure|McIvor retractor|The Mclvor blade- guided technique (McIvor group) involved the following steps. The PLMA was lubricated on the posterior aspect of the deflated mask with a water-based lubricant. The McIvor blade was fully inserted beneath the tongue of the patients. The tongue was lifted gently with the McIvor blade and PLMA was introduced into a space between the McIvor blade and maxillary incisors holding the bite block of the PLMA. The PLMA was advanced into the hypopharynx until definite resistance was felt and McIvor blade was removed.
16226207|NCT01191606|Procedure|the change of ventilatory mode|One lung ventilation initiated with volume controlled ventilation(OLV-VCV) with an inspired oxygen fraction (FIO2) of 1.0, a tidal volume 6 mL/kg based on PBW and respiratory rate to maintain PaCO2 between 35-45 mmHg. After 30 min, the ventilator was switched to pressure controlled ventilation and the inspiratory pressure was adjusted to obtain the tidal volume 6 mL/kg. No external positive end-expiratory pressure was applied throughout the entire study. Arterial PaO2, PaCO2, peak inspiratory pressure (Ppeak), mean inspiratory pressure (Pmean), plateau inspiratory pressure (Pplateau) were recorded at the end of each ventilaroty mode.
16226208|NCT01191606|Procedure|the change of ventilatory mode|One lung ventilation initiated with pressure controlled ventilation with an inspired oxygen fraction (FIO2) of 1.0, an inspiratory pressure provided the tidal volume 6 mL/kg based on PBW and respiratory rate to maintain PaCO2 between 35-45 mmHg. After 30 min, the ventilator was switched to VCV with a tidal volume 6 mL/kg based on PBW. No external positive end-expiratory pressure was applied throughout the entire study. Arterial PaO2, PaCO2, peak inspiratory pressure (Ppeak), mean inspiratory pressure (Pmean), plateau inspiratory pressure (Pplateau) were recorded at the end of each ventilaroty mode.
16226209|NCT01191593|Procedure|Adductor-Canal-Blockade with Ropivacaine|US-guided Adductor-Canal-Blockade with ropivacaine 7,5 mg/ml
16226210|NCT01191593|Procedure|Adductor-Canal-blockade with saline|US-guided Adductor-Canal-blockade with saline
16226211|NCT01191580|Behavioral|Interpersonal Psychotherapy|Interpersonal Psychotherapy will consist of twelve 50-minute sessions delivered within a period of 16 weeks. IPT is divided into three phases.
16226212|NCT01191580|Behavioral|Problem-Solving Therapy|Problem-Solving Therapy will also consist of 12 50-minute sessions. The goals of the PST are: 1) to assist patients to identify and link life situations related to the depression; 2) to increase the effectiveness of the patient's problem-solving attempts at coping with current problems based on an intervention carried out in a concrete, structured and, unambiguous manner.
16226213|NCT01191580|Behavioral|Brief Supportive Psychotherapy|"The treatment approach will follow the standard supportive therapy approaches used in depression and medical illness, as noted below.
~Brief Supportive Psychotherapy has a biopsychosocial perspective, recognizing contributions of genetic predisposition and neuroendocrine factors (Novalis et al., 1993, p. 257-277). Its goals are to maximize patient function during crisis, to support the patient's judgment with the therapist's reasoning skills, and to engender hope for recovery. Primary techniques and practices include reality testing; being relatively accepting of existing defenses but attempting to restructure them when appropriate; and, using self-esteem enhancing measures."
16226214|NCT01191567|Procedure|VAC treatment|wound treatment with VAC-therapy
16226215|NCT01191567|Procedure|Conventional treatment|wound treatment with conventional treatment according to the hospitals local routines
16226216|NCT01191554|Drug|Tranexamic Acid|High and low dosage. Loading dose followed by continuous infusion in operation.
16226217|NCT01191541|Drug|DNR:|DNR：45mg/m2 d1-3
16226218|NCT01191541|Drug|Ara-c|DNR+ARA-C：DNR：45mg/m2 d1-3;Ara-C :1g/m2 d1-3
16226219|NCT01191528|Device|capnostream 20, Oridian Medical 1987 ltd, Needham MA|"Oxygen blood saturation measured by a s sensor that reflects infrared light on oxygenated and deoxygenated arterial blood via a noninvasive, clip on digit sensor connected to a combination capnometer and pulse oximeter monitor.
~End-tidal Carbon dioxide (EtCO2) is measured with a noninvasive nasal cannula sampling line which calculates the EtCO2 from exhaled air. Measurements recorded at 5 second intervals."
16226220|NCT01191515|Device|Monofocal Intraocular Lenses|Monofocal Intraocular Lenses
16226221|NCT01191489|Device|High Flow Conditioned Oxygen Therapy in High Risk Patients|OptiFlow system (R) with nasal cannula.
16226222|NCT01191489|Device|Non-invasive mechanical ventilation|Bilevel pressure support through a facial mask
16226223|NCT01191489|Device|Conventional Oxygen Therapy|Conventional Oxygen Therapy with nasal cannula or Venturi facial mask.
16226224|NCT01191476|Drug|Sevoflurane Inhalational Induction and Maintenance|Sevoflurane was administered at a concentration of 8% via vital capacity induction and sevoflurane 0.8-1.5 minimum alveolar concentration (MAC) with a rate of 1 L/min fresh gas flow for maintenance.
16226225|NCT01191476|Drug|Propofol Target Controlled Infusion for Induction and Maintenance|Propofol IV 4 ug/mL was administered with target controlled infusion (TCI) for induction and propofol 3 to 6 ug/mL was administered with TCI for maintenance.
16226226|NCT01191476|Drug|Propofol Target Controlled Infusion for Induction and Sevoflurane Inhalation for Maintenance|Propofol was administered as a bolus IV dose of 1.5 mg/kg for induction at a rate of 40 mg/10 seconds. During maintenance, a sevoflurane concentration of 0.8-1.5 minimal alveolar concentration (MAC) was administered at a rate of 1 L/min fresh gas flow.
16226227|NCT01191463|Other|Mung Bean Meal|50g mung beans will be cooked to a curry with oil, spices and small amounts of vegetables.
16226228|NCT01191463|Other|Guava|A fresh Guava fruit will be provided raw (approx 100g fresh weight)
16226229|NCT01191450|Drug|Chlorthalidone 25 mg + amiloride hydrochloride 5 mg|Chlorthalidone 25 mg + amiloride hydrochloride 5 mg - one oral tablet a day in the morning during approximately 12 weeks
16226230|NCT01191450|Drug|Higroton® Laboratório Novartis|Chlortalidone 25mg - oral tablet a day in the morning during approximately 12 weeks
16226231|NCT01191424|Drug|CHF1535 NEXT DPI|FIXED COMBINATION OF BECLOMETHASONE DIPROPIONATE 100µg PLUS FORMOTEROL FUMARATE 6 µg DRY POWDER INHALER
16226232|NCT01191424|Drug|BDP DPI and formoterol DPI|FREE COMBINATION OF LICENSED BECLOMETHASONE DPI AND FORMOTEROL DPI
16226233|NCT01191411|Other|Mailed invitations for FIT test kits|Mailed invitations for the non-invasive immunochemical stool blood test will be the intervention compared to the standard care at John Peter Smith Hospital. Patients will be invited to complete a free home-based, non-invasive immunochemical stool blood test.
16226234|NCT01191411|Other|Mailed invitations for a colonoscopy|These patients will be mailed invitations to directly book a free colonoscopy, or to see a physician for free pre-operative screening at John Peter Smith Hospital.
16226235|NCT01191411|Other|Visit Based Care|Visit based standard care at John Peter Smith Hospital. Patients will continue to see their regular physician and follow the physician's recommendations as they normally would.
16226236|NCT01191398|Drug|Atropine (0.01mg/kg)|Atropine will be given at 0.01mg/kg with a minimum dosage of 0.1mg and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
16226237|NCT01191398|Drug|Glycopyrrolate (0.01mg/kg)|Glycopyrrolate will be given at 0.01mg/kg with no minimum dosage and a maximum dosage of 0.4mg. This medication will be given once by IV 30 minutes before the administration of Ketamine.
16226238|NCT01191398|Drug|Normal saline 0.9%|Normal Saline of 0.9% will be given at a volume of 2mL. This medication will be given once by IV 30 minutes before the administration of Ketamine
16226239|NCT01191385|Drug|Any treatment for unresectable HCC as chosen by the physician|Only those patient are allowed to be enrolled that receive any HCC treatment for unresectable HCC as chosen by the physician except sorafenib. During the course of the study, each treatment is allowed.
16226240|NCT01191372|Drug|placebo control|sterile saline for injection
16226241|NCT01191372|Drug|ARC19499|Anti-tissue factor pathway inhibitor (TFPI) aptamer
16226242|NCT01191359|Biological|oral immunotherapy|orally applied specific immunotherapy
16226243|NCT01191346|Other|3T MRI|3T MRI in addition to standard 1.5T MRI for treatment planning
16226244|NCT01191333|Device|rTMS|Repetitive Transcranial Magnetic Stimulation
16226245|NCT01191333|Device|Sham Device|Placebo Device that simulates active rTMS treatment
16226246|NCT01191320|Drug|Placebo|Placebo capsule 1x daily for 3 months
16226247|NCT01191320|Drug|Androxal|Capsules 12.5 mg or 25 mg 1x daily for 3 months
16226248|NCT01191294|Other|Simulation teaching session|Simulation-based, mastery learning educational intervention in visual screening for melanoma
16226249|NCT01191281|Behavioral|Diet/nutrition counsel+food aid|Patients enrolled in the experimental arm will receive dietary and nutritional assistance plus a food aid basket, specifically tailored to meet the nutritional needs of the target population.
16226250|NCT01191281|Other|Dietary/nutrition counsel|Patients enrolled in the active comparison arm will receive dietary and nutrition counseling designed to help them meet their nutrition needs, based on foods which are locally available, culturally acceptable and within their budget.
16226251|NCT01191268|Drug|Insulin Glargine|
16226252|NCT01191268|Drug|LY2189265|
16226253|NCT01191268|Drug|Insulin Lispro|
16226254|NCT01191255|Drug|ferric citrate, ca acetate, sevelamer carbonate, placebo|All intervention doses will be based on serum phosphorus levels and/or drug label requirements
16226255|NCT01191229|Device|Tecnis one-piece MF IOL|25 patients to be implanted after cataract surgery
16226256|NCT01191229|Device|Crystalens AO|25 patients that are previously implanted
16226257|NCT01191216|Drug|1-methyl-d-tryptophan|
16226258|NCT01191216|Drug|docetaxel|
16226259|NCT01191216|Other|diagnostic laboratory biomarker analysis|
16226260|NCT01191216|Other|pharmacological study|
16226261|NCT01191203|Drug|Copper IUD|Copper IUD (CuT360)
16226262|NCT01191203|Drug|Depo Medroxyprogesterone acetate|DMPA 150 mg IM q 3 months
16226263|NCT01191190|Drug|Ofatumumab/HDMP|"High dose methylprednisolone sodium succinate (HDMP) at 1gm/m2 daily as infusion for 3 consecutive days every cycle.
~Ofatumumab 300mg administered Day1 of cycle 1 followed by 12 doses of 1000mg administered based on specific schedule.
~Each patient will receive a maximum of 3 cycles (one cycle is 28 days)"
16226264|NCT01191177|Drug|Lovaza (omega-3-acid ethyl ester)|supplied as 1gram transparent soft-gelatin capsules filled with yellow oil, dosage is 1gram per kilogram of body weight per day, not exceeding 4grams per day until normalization of liver function test
16226265|NCT01191177|Dietary Supplement|Corn oil|1 gram per kilogram body weight per day, not exceeding 4 grams
16226266|NCT01191164|Procedure|Partial Breast Irradiation Utilizing Permanent Breast Seed Implant|"Target Volumes: The surgical cavity will be assessed with US & CT scans. The Clinical Target Volume (CTV) will encompass the surgical cavity plus 1 cm uniform expansion. The Planning Target Volume (PTV) will be the CTV plus 0.5 cm.
~Dose Selection/Prescription: A minimal peripheral dose of 90 Gy (same as in the OCC study) will be prescribed to the PTV. This dose is chosen as biologically equivalent, over a 2 month period, to 50Gy in 25 fractions, for α/β of 2Gy54.
~Implant Procedure and QA: This will be performed as an outpatient procedure under conscious sedation and local anesthesia, by a team with several years experience in brachytherapy and conscious sedation administration. The technique used in this pilot study will be based on the OCC technique. It is intended that two oncologists and one physicist will spend 2-3 days at the OCC to acquire detailed and firsthand knowledge of the technique and its implementation at that centre."
16226267|NCT01191138|Procedure|Infracolic gastrojejunal anastamosis|Following resection in whipples pancreaticoduodenectomy, the gastrojejunal anastamosis is done in the infracolic compartment by bringing down the stomach below the mesocolon to the left of the middle colic artery
16226268|NCT01191138|Procedure|Supracolic gastrojejunal anastamosis|Following resection in whipples pancreaticoduodenectomy, the gastrojejunal anastamosis is done in the supracolic compartment.
16226269|NCT01191125|Other|medical food with AN777|Two(220 mL)servings every day for six months
16226270|NCT01191125|Other|oral nutritional formula|Two (220 mL) servings daily for six months
16226271|NCT01191112|Other|Peptide based enteral formula|Sole source nutrition as per HCP
16226272|NCT01191099|Device|Pimonidazol|0.5gm/m2 Pimonidazol i.v. 16-24 hours before prostatectomy
16226273|NCT01191086|Drug|USL255|
16226274|NCT01191073|Device|CAD/CAM fabricated RPD's|group receiving Computer-Aided Design/Computer-Aided Manufacturing (CAD/CAM)fabricated removable partial dentures (double blind)
16226275|NCT01191073|Device|traditional fabricated RPD's|group receiving traditional fabricated dentures (double blind)
16226276|NCT01191060|Drug|Lenalidomide, Bortezomib|"Lenalidomide/Bortézomib/Dexamethasone cycles:
~Number of cycles: 8 cycles for arm A
~Cycle length
~Dosage:
~Lenalidomide: 25 mg/day on days 1-14 of each cycle
~Bortézomib: 1.3 mg/m2 on days 1, 4, 8, and 11 for 1 cycle of each cycle
~Maintenance phase (12 months):
~Cycle length: 28 days Dosage: Lenalidomide: 10 mg/day continuously for 28 days during 3 months and if the participant tolerates 10 mg/day without complication, a dose increase to 15 mg/day will be allowed"
16226314|NCT01190826|Drug|ASM-024 100 mg|Target dose of 100 mg ASM-024 administered once by inhalation
16226277|NCT01191060|Drug|Lenalidomide, Bortezomib|"Lenalidomide Bortezomib Dexamethasone cycles:
~Number of cycles: 5 cycles for arm B
~Cycle length
~Dosage:
~Lenalidomide: 25 mg/day on days 1-14 of each cycle
~Bortézomib: 1.3 mg/m2 on days 1, 4, 8, and 11 for 1 cycle of each cycle
~Maintenance phase (12 months):
~Cycle length: 28 days Dosage: Lenalidomide: 10 mg/day continuously for 28 days during 3 months and if the participant tolerates 10 mg/day without complication, a dose increase to 15 mg/day will be allowed"
16226278|NCT01191034|Drug|Vaccine MAGE-3.A1 peptide, or the NA17.A2 peptide + IL-2, IFN-α and GMCSF, Imiquimod.|"The vaccine will be either the MAGE-3.A1 peptide, or the NA17.A2 peptide, or both,matching the patient's HLA type and the gene expression of his tumor. If both antigens are expressed, then the patient will receive both peptides.
~This treatment will combine subcutaneous peritumoral injections of IL-2, IFN-α and GMCSF,as well as topical applications of imiquimod."
16226279|NCT01191021|Drug|Propofol Anesthesia|Volunteers will undergo propofol anesthesia for 90 min.
16226280|NCT01191008|Drug|Latanoprost-timolol maleate fixed combination ophthalmic solution|"Xalacom® Combination Eye Drops depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. One drop should be applied to the affected eye(s) once daily."
16226281|NCT01190995|Drug|24% Sucrose|The enrolled neonates will be administered either a sterile solution of 24 % sucrose or double distilled water orally for a period of 7 days from enrollment. At the beginning of each potentially painful procedure namely, venepuncture, venous and arterial cannulation, heel lance,orogastric tube insertion, suprapubic aspiration of urine and any other skin breaking procedure,0.5ml of solution marked with patients serial number will be administered by a prefilled syringe to the patient on the anterior aspect of the tongue , avoiding spillage , by the personnel carrying out the procedure
16226282|NCT01190995|Drug|Placebo|The patient will be enrolled into the study only after an informed written consent has been obtained from either of the parent/caregiver. At the beginning of each potentially painful procedure namely, venepuncture, venous and arterial cannulation, heel lance,orogastric tube insertion, suprapubic aspiration of urine and any other skin breaking procedure,0.5ml of solution marked with patients serial number will be administered by a prefilled syringe to the patient on the anterior aspect of the tongue , avoiding spillage , by the personnel carrying out the procedure
16226283|NCT01190982|Drug|LEP-ETU|275 mg/m2, IV (in the vein) on day 1 of each 21 day cycle, 6 Cycles or until progression or unacceptable toxicity develops.
16226284|NCT01190969|Dietary Supplement|Nutritional Supplement (Ensure Plus)|Subjects will be provided with 2 to 3 serves of Ensure Plus (complete nutritional beverages) and to be taken between meals
16226285|NCT01190943|Other|Laboratory Biomarker Analysis|Correlative studies
16226286|NCT01190930|Drug|Cyclophosphamide|Given IV
16226287|NCT01190930|Drug|Cytarabine|Given IT, IV, or SC
16226288|NCT01190930|Drug|Dexamethasone|Given orally (PO) or IV
16226289|NCT01190930|Drug|Doxorubicin Hydrochloride|Given IV
16226290|NCT01190930|Other|Laboratory Biomarker Analysis|Correlative studies
16226291|NCT01190930|Drug|Leucovorin Calcium|Given PO
16226292|NCT01190930|Drug|Mercaptopurine|Given PO
16226293|NCT01190930|Drug|Methotrexate|Given IT, PO, or IV
16226294|NCT01190930|Drug|Pegaspargase|Given IV
16226295|NCT01190930|Other|Quality-of-Life Assessment|Ancillary studies
16226296|NCT01190930|Other|Questionnaire Administration|Ancillary studies
16226297|NCT01190930|Drug|Thioguanine|Given PO
16226298|NCT01190930|Drug|Vincristine Sulfate|Given IV
16226299|NCT01190917|Behavioral|Cognitive Behavioral Therapy (CBT)|The CBT social skills curriculum is manualized and anchored in CBT strategies, such as problem identification, affective education, performance feedback, and weekly homework activities to facilitate generalization. The curriculum is a compilation of lessons targeting key social deficits in children with ASD, such as nonverbal communication, emotion recognition, and theory of mind. Structured teaching includes defining skills, breaking them down into simple, concrete steps, modeling the skill through role-play, and introducing a game or activity to practice the target skill. The approach to the parent group will be psychoeducational with a focus on reviewing target skills, rationale for teaching target skills, homework, progress or obstacles, and identifying strategies to promote generalization. Parent information handouts will be provided.
16226300|NCT01190917|Behavioral|Play Therapy|The social play group is manualized, led by a trained clinician and support staff, follows a specific routine, and contains a parent group component. Group leaders will follow participants' interests and suggestions for games. Group leaders utilize strategies such as reflective functioning statements on the child's behaviors to build emotion-focused play skills. The therapeutic setting incorporates play designed to encourage emotion-focused play including make-believe (dolls, houses), sensory (e.g. play-doh), and cooperative play (e.g. board games) toys. The approach to the parent group will be supportive rather than psychoeducational. Parents will set the agenda for discussion, facilitated by the group leader.
16226301|NCT01190891|Procedure|Manual Physical Therapy|Same as arm description
16226302|NCT01190891|Procedure|Corticosteroid Injection|Dose represents a glucocorticoid potency of 400 hydrocortisone equivalents/injection (mg).
16226303|NCT01190878|Drug|ISV-303|0.075% of bromfenac in DuraSite dosed QD
16226304|NCT01190878|Drug|ISV-303|0.075% of bromfenac in DuraSite dosed BID
16226305|NCT01190878|Drug|DuraSite Vehicle|Vehicle dosed BID
16226306|NCT01190878|Drug|Xibrom™|0.09% bromfenac dosed BID
16226307|NCT01190865|Biological|HP802-247|One dose of HP802-247 consisting off 260 mL containing keratinocytes and fibroblasts totaling 5.0 x 10.6 cells per mL, plus fibrin.
16226308|NCT01190852|Drug|Azelastine, Fluticasone|TEST = MP29-02 = Combination product Azelastine Hydrochloride and Fluticasone Propionate nasal spray
16226309|NCT01190852|Drug|Azelastine mono|REF = AZE mono Azelastine Hydrochloride nasal spray (= essentially combination product formulation without any FLU; US AZE mono formulation as used in pivotal studies)
16226310|NCT01190852|Drug|Azelastine|COMP = Astelin® Nasal Spray = AZE mono Azelastine Hydrochloride nasal spray (= US marketed product)
16226311|NCT01190839|Biological|Infliximab|Type=equal, unit=mg, number=5, form=intravenous infusion, route=intravenous use, once every 8 weeks
16226312|NCT01190839|Drug|Placebo|Type=equal, unit=mg, number=5, form=intravenous infusion, route=intravenous use, once every 8 weeks
16226313|NCT01190826|Drug|ASM-024|Target dose of 10 mg ASM-024 administered once by inhalation
16226316|NCT01190813|Drug|Levodopa/Carbidopa|Oral levodopa 0.76 mg/kg tid with carbidopa 0.17 mg/kg tid
16226317|NCT01190813|Drug|Placebo|Oral placebo tid
16226318|NCT01190813|Other|Patching|Two hours of daily patching
16226319|NCT01190787|Drug|velcade subcutaneous melphalan prednisone|"INDUCTION Velcade will be given as subcutaneous (SC) injection. Each cycle will be repeated every 28 days.
~Melphalan will be given orally. Each cycle will be repeated every 28 days. Prednisone will be given orally.Each cycle will be repeated every 28 days. MAINTENANCE Velcade will be given a SC injection. Each cycle will be repeated every 28 days."
16226320|NCT01190787|Drug|velcade cyclophosphamide prednisone|"INDUCTION Velcade will be given as subcutaneous (SC) injection. Each cycle will be repeated every 28 days.
~Cyclophosphamide will be given orally. Each cycle will be repeated every 28 days.
~Prednisone will be given orally.Each cycle will be repeated every 28 days. MAINTENANCE Velcade will be given a SC injection. Each cycle will be repeated every 28 days."
16226321|NCT01190787|Drug|velcade prednisone|"INDUCTION Velcade will be given as subcutaneous (SC) injection. Each cycle will be repeated every 28 days.
~Prednisone will be given orally.Each cycle will be repeated every 28 days. MAINTENANCE Velcade will be given a SC injection. Each cycle will be repeated every 28 days."
16226322|NCT01190774|Behavioral|Information to health provider without patient knowledge|The intervention consists of the assessment information from the MDAS questionnaire being given to the dentist via the receptionist without the knowledge of the patient
16226323|NCT01190774|Behavioral|dentist behaviour and patient expectancy|patient give information about their dental anxiety to the dentist
16226324|NCT01190761|Drug|Galantamine 4 mg Tablet, single dose|A: Experimental Subjects received Purepac Pharmaceutical, Company, U.S.A. formulated products under fed conditions
16226325|NCT01190761|Drug|Reminyl 4 mg Tablet, single dose|B: Active comparator Subjects received Janssen Pharmaceutica Products,U.S.A., formulated products under fed conditions
16226326|NCT01190748|Drug|Galantamine 4 mg Tablet, single dose|A: Experimental Subjects received Purepac Pharmaceutical, Company, U.S.A. formulated products under fasting conditions
16226327|NCT01190748|Drug|Reminyl 4 mg Tablet, single dose|B: Active comparator Subjects received Janssen Pharmaceutica Products,U.S.A., formulated products under fasting conditions
16226328|NCT01190735|Drug|Caffeine alkaloid|"The following intervention will be provided for six consecutive weeks:
~Week 1 (100 mg BID), Week 2 (200 mg BID), Week 3 (300 mg BID), Week 4 (400 mg BID), Week 5 and 6(500 mg BID). At the conclusion of the study, patients will decrease their dose by 100 mg BID every other day, until caffeine is stopped. This gradual reduction will be to prevent withdrawal symptoms. If a patient experiences a dose-limiting event, they will be terminated from the study, and will withdraw from the medication in the same manner. If dose-limiting events occur between visits, patients will be encouraged to decrease the caffeine dose back to the previously-tolerated dose until in-person assessment can be performed."
16226329|NCT01190722|Drug|etoricoxib|120 mg once daily for the 1st 6 postoperative days
16226330|NCT01190722|Drug|Diclofenac|50 mg oral 3 times daily the 1st 6 postoperative days
16226331|NCT01190709|Procedure|Dynamic Compression Plate|we made a longitudinal incision 1 cm lateral to the tibial crest, expose the fracture, and retract the muscles laterally. After determining the length of plate, we used bending instruments to contour the plate to the anatomy then threaded plate holders used to position the plate on the bone. After that we placed the drill guide at the edge of the dynamic compression unit (DCU) portion of the plate hole without applying pressure and tightening of the cortex screws results in dynamic compression. We verified the screw position with a guide wire before insertion and then inserted the locking screw.
16226332|NCT01190709|Procedure|Unreamed intramedullary nailing|we inserted the nail, without reaming, across the fracture site, with particular attention being paid to the prevention of over distraction and the achievement of cortical contact of the fracture ends. An upper diameter limit of 10 mm and a nail measuring at least 2 mm less than the diameter measured at the isthmus of the tibia on anteroposterior and lateral radiographs were stipulated.
16226333|NCT01190696|Procedure|titanium elastic nailing|we inserted titanium nail in femoral fractures retrogradely
16226334|NCT01190696|Device|Hip spica casting|we applied cast for three weeks in patients with femoral shaft fracture
16226335|NCT01190683|Drug|Cholecalciferol|60,000 IU/week for ist eight weeks followed by 60,000 IU every 15 days for four months
16226336|NCT01190683|Drug|Calcium Carbonate|two tablets of calcium carbonate daily containing 1 gm of elemental calcium for six months
16226337|NCT01190683|Drug|cholecalciferol and calcium carbonate|60,000 IU of cholecalciferol for first eight weeks and then 60,000IU for next four months along with 1 gm of elemental calcium daily for six months
16226338|NCT01190683|Other|lactose placebo|similar number of granules and tablets as active group
16226339|NCT01190683|Other|lactose granules and tablets|one sachet every week for eight weeks followed by two sachets every month along with two lactose tablets daily
16226340|NCT01190670|Drug|Tacrolimus|Oral and Intravenous
16226341|NCT01190670|Drug|ASP015K|Oral
16226342|NCT01190657|Drug|Selbex|50mg/day, 3 times/day, for 14 days
16226343|NCT01190657|Drug|Selbex|50mg/day, 3 times/day, for 56 days
16226344|NCT01190644|Drug|ACE 011|35 mg subcutaneous (SC) dose on study Day 1, Day 43, Day 85
16226345|NCT01190631|Device|Acrysof IQ (SN60WF) IOL|Acrysof IQ (SN60WF) intraocular lens implanted in the capsular bag of the eye during cataract surgery. The IOL is intended for the lifetime of the patient. Unilateral (one eye only) implantation is planned.
16226346|NCT01190592|Other|Resistance Training with Milk Supplementation in Adolescents|"On resistance training days, the RT+ milk group will receive milk (280kcals) immediately following exercise and milk at another time during the day. The RT+ juice group will receive fruit juice immediately following resistance exercise and juice again another time during the day. The RT+ water group will receive water following resistance exercise and water at another time during the day.
~On non training days, students in the RT+ milk group will receive milk. Students in the RT+ juice group will receive juice. The RT+ water group will receive water during the school day. On non-RT days, the total volume of milk, juice, or water will be split into two administration times during the school day."
16226347|NCT01190553|Drug|Amantadine|Initiation: IV amantadine 200mg/500ml * 1/d for 3 days Maintenance: IV amantadine 200mg/500ml once per 6 weeks for 6 months
16226385|NCT01190306|Device|The VEGA UV-A Illumination System|This is a portable electronic device designed to deliver a dose of UV-A light to the treatment area
16226348|NCT01190540|Behavioral|Training and supervision|On-Site-Support (OSS) service training will occur monthly for a period of 9 months. This training and supervision will support the proper utilization of newly learned clinical skills.
16226349|NCT01190540|Behavioral|Training and Supervision|On-Site-Support (OSS) service training will occur monthly for a period of 9 to 15 months. This training and supervision will support the proper utilization of newly learned clinical skills and continuous quality improvement of processes of care. For the control group, the OSS training will occur during phase 2, after a randomly assigned wait list control period.
16226350|NCT01190540|Behavioral|Integrated Management of Infectious Disease (IMID)|The IMID is a 9-month training program that begins with a three-week course at the Infectious Diseases Institute (IDI) in Kampala Uganda. After the course participants engage in 12 weeks of distance learning followed by a one-week boost course at the IDI. Then the engage in 12 more weeks of distance learning and a final one-week boost course. This intervention is offered to two clinicians (clinical officers or registered nurses or midwives) at every OSS Phase 1 and OSS Phase 2 site.
16226351|NCT01190540|Behavioral|Integrated Management of Infectious Disease (IMID)|The IMID is a 9-month training program that begins with a three-week course at the Infectious Diseases Institute (IDI) in Kampala Uganda. After the course participants engage in 12 weeks of distance learning followed by a one-week boost course at the IDI. Then the engage in 12 more weeks of distance learning and a final one-week boost course. This intervention is offered to two clinicians (clinical officers or registered nurses or midwives) at every OSS Phase 1 and OSS Phase 2 site.
16226352|NCT01190527|Radiation|FDG-PET|This study is designed to apply functional imaging, Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) before treatment and again during treatment to see if it helps predict how well the treatment works for the cancer. The standard of care for patients with stage III unresectable NSCLC is combined chemoradiotherapy. This study will seek to determine 2 year local-regional progression free survival in patients with non-small cell lung cancer (NSCLC) when an adaptive plan is applied based on repeat PET-CT imaging during the course of radiation therapy (during RT), and investigate if there is an improvement compared to those treated with conventional radiation therapy without field and/or dose modification. The investigators hypothesize that during-RT, PET-CT-based adaptive therapy will allow them to dose escalate in the majority of patients and meet the dose limits of normal structures, thus improving local tumor control without increasing toxicity.
16226353|NCT01190514|Drug|desvenlafaxine succinate sustained release|Two tablets of 25 mg, single administration, under fed condition
16226354|NCT01190514|Drug|desvenlafaxine succinate sustained release|One tablet of 50 mg, single administration, under fed condition
16226355|NCT01190514|Drug|desvenlafaxine succinate sustained release|Two tablets of 25 mg, single administration, under fast condition
16226356|NCT01190514|Drug|desvenlafaxine succinate sustained release|One tablet of 50 mg, single administration, under fast condition
16226357|NCT01190501|Device|complier device|"The procedure of use of complier has to follow the recommendations for standardization of subject conditions.
~Assessment of arterial distensibility: pulse wave velocity (PWV), aortic stiffness is assessed by PWV which is a classic index of arterial stiffness. A semi-automatic device is used to measure carotid-femoral PWV. The distance covered by the pulse wave is measured on the surface of the body and represented the distance between the 2 recording sites."
16226358|NCT01190488|Behavioral|End-of-Life / Advanced Care Decision Aid|Patients assigned to the control group will receive usual care which includes a discussion of knowledge about their medical condition as well as their goals of care. Typically, this discussion includes one physician and one advanced practice nurse however there are occasions such as weekends and during clinic time where the consult will have only one palliative care team member. This consultation typically includes a discussion of advanced directives using the five wishes document.
16226359|NCT01190488|Behavioral|Active Comparator|TAU
16226360|NCT01190475|Drug|Active treatment with a high dose of BGS649|
16226361|NCT01190475|Drug|Active treatment with a low dose of BGS649|
16226362|NCT01190475|Drug|Placebo treatment to blind study|
16226363|NCT01190462|Biological|cetuximab|
16226364|NCT01190462|Drug|simvastatin|
16226365|NCT01190462|Other|laboratory biomarker analysis|
16226366|NCT01190449|Biological|ofatumumab|Given IV
16226367|NCT01190436|Drug|Bisoprolol|Bisoprolol will be administered at an initial dose of 5 milligram (mg) once daily for 2 weeks. If the blood pressure would be greater than or equal to 130/80 mmHg after 2 weeks, then dose will be adjusted to 10 mg once daily. Total duration of study treatment will be 12 weeks.
16226368|NCT01190423|Behavioral|Family Based Therapy for young adults|Individual and Group Therapy Sessions
16226369|NCT01190410|Drug|certolizumab pegol|400 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 200 mg for subjects 20 to < 40 kg
16226370|NCT01190410|Drug|certolizumab pegol|200 mg administered subcutaneously every 4 weeks for subjects ≥ 40 kg or 100 mg for subjects 20 to < 40 kg
16226371|NCT01190397|Device|Warming goggles|
16226372|NCT01190397|Device|warm and moist compresses|
16226373|NCT01190384|Other|Couscous plus fiber|Soup with added fiber to equal Bean soup. Subjects' serving size is isocaloric to the experimental Bean soup.
16226374|NCT01190384|Dietary Supplement|Grape seed extract|300 milligrams of grape seed extract in capsule form will be consumed with the low ORAC value soup.
16226375|NCT01190384|Other|Bean Soup|Experimental soup with a high fiber content and ORAC value. The ORAC value is the Oxygen Radical Absorbance Capacity (ORAC) score which is a measure of the antioxidant levels of food and is expressed as Trolox Equivalents. The antioxidants in the soup are derived from beans.
16226376|NCT01190371|Drug|Artesunate|Oral, once daily, 7-day regimen of artesunate 2mg/kg/day
16226377|NCT01190358|Dietary Supplement|Placebo|Sugar pill containing maltodextrin.
16226378|NCT01190358|Dietary Supplement|Grape seed extract|Meganatural Gold® contains 300mg of grape seed extract.
16226379|NCT01190345|Drug|bevacizumab|Patients receive on day 1 of each cycle : bevacizumab 15 mg/kg (8 injections in total).
16226380|NCT01190345|Drug|no bevacizumab|no bevacizumab
16226381|NCT01190332|Procedure|endoscopic sphincterotomy by conventional method|
16226382|NCT01190332|Procedure|endoscopic sphincterotomy by rendezvous method|
16226383|NCT01190319|Other|Strawberry Beverage|Beverage, daily for 8 weeks, 12g freeze-dried strawberry powder
16226384|NCT01190319|Other|Placebo|Placebo beverage, 8 weeks
16226386|NCT01190306|Drug|Riboflavin|Riboflavin is a solution that will be delivered to the treatment area
16226387|NCT01190293|Drug|Maraviroc|All patients (previously on an efavirenz-based therapy) will be administered maraviroc at 600mg twice-daily for 2 weeks.
16226388|NCT01190280|Procedure|Cholecystectomy operation|Cholecystectomy after randomization
16226389|NCT01190267|Drug|asenapine|asenapine 2.5 mg or 5.0 mg sublingual tablets, administered BID
16226390|NCT01190254|Drug|asenapine 2.5 mg|asenapine 2.5 mg tablets for sublingual administration
16226391|NCT01190254|Drug|asenapine 5.0 mg|asenapine 5.0 mg tablets for sublingual administration
16226392|NCT01190254|Drug|placebo|asenapine-matched placebo tablets for sublingual administration
16226393|NCT01190241|Drug|desatinib or sunitinib or erlotinib or everolimus or lapatinib or sorafenib|The drug will be selected based on ex vivo test on the tumor tissue. The patients will be treated with the selected drug until disease progression.
16226394|NCT01190228|Biological|JE-CV Vaccine|0.5 mL (single dose), Subcutaneous
16226395|NCT01190228|Biological|Varicella Vaccine|0.5 mL (single dose), Subcutaneous
16226396|NCT01190215|Biological|FluarixTM|One Intramuscular injection
16226397|NCT01190215|Biological|HavrixTM Junior (in subjects of 15 years old or below) or HavrixTM (in subjects above 15 years old)|Two Intramuscular injections
16226398|NCT01190202|Procedure|Blood sampling|Capillary blood samples collected by finger/heel prick
16226399|NCT01190202|Procedure|Assessment of body temperature|Assessment of axial body temperature with a digital thermometer
16226400|NCT01190189|Biological|GSK580299 (Cervarix)|3-dose schedule intramuscularly vaccination
16226401|NCT01190176|Procedure|Gynaecological follow-up|Subjects will receive a gynaecological follow-up with cytology and oncogenic HPV DNA testing every 12 months, for up to a maximum of four years.
16226402|NCT01190176|Biological|Cervarix|Subjects received 3 doses of the HPV vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule in the primary study HPV-015.
16226403|NCT01190176|Biological|Placebo control|Subjects received 3 doses of the control [Al(OH)3] administered intramuscularly according to a 0, 1, 6 month vaccination schedule in the primary study HPV-015.
16226404|NCT01190163|Drug|Dinoprostone|
16226405|NCT01190163|Drug|Oxytocin|
16226406|NCT01190150|Drug|tranexamic acid|Either one or two modified-immediate release tranexamic acid tablets (0.65 g each) taken orally, administered with 240 mL of water, as a single dose, at approximately 8 AM.
16226407|NCT01190137|Dietary Supplement|Cholecalciferol (D3) or ergocalciferol (D2)|400 IU administered as 1 drop daily for 3 months
16226408|NCT01190111|Biological|Interleukin-7|20 µg/kg/week. 3 administrations, 1 per week (1 cycle) repeated cycles based on a CD4-guided response
16226409|NCT01190098|Drug|Lacosamide|"Subjects randomized to lacosamide according to the following schedule:
~Treatment Phase Week Dose Week 1 LCM 50 mg bid Week 2 LCM 100 mg bid Week 3 LCM 150 mg bid Week 4 LCM 200 mg bid"
16226410|NCT01190098|Drug|Placebo|Placebo will be packaged identically to experimental drug and titrated according to the same schedule.
16226411|NCT01190085|Drug|Ghrelin|A 1 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
16226412|NCT01190085|Drug|Ghrelin|A 3 microg/kg dose of intravenous human acetylated ghrelin was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
16226413|NCT01190085|Drug|Saline solution|Intravenous saline solution (matched placebo) was administered once approximately 10 minutes before the start of the alcohol cue-reactivity experiment.
16226414|NCT01190059|Drug|Ex vivo lung perfusion with Steen Solution™|The circuit is primed with 2,000cc Steen Solution™. At one hour of EVLP, 500 cc of circulated perfusate was removed and replenished with 500 cc of fresh perfusate. After that, 250 cc of perfusate was exchanged every hour.
16226415|NCT01190046|Behavioral|Resistance exercise training|Lower extremity resistance exercise training 3x/wk
16226416|NCT01190033|Device|Neurotome OFF|In this intervention the neurotome will be unconnected.
16226417|NCT01190033|Procedure|neurolysis|In this procedure the neurotome will be connected
16226418|NCT01190020|Drug|Lubiprostone|Colonic transit study performed and stool/symptom diaries will be reviewed. Eligible subjects will be given a lactulose breath test and randomized to Lubiprostone or placebo. Treatment group receives 24 mcg Lubiprostone twice daily and placebo group receives pills (identical in appearance to the study drug) for one month. Subjects will be asked to maintain a daily stool/symptom diary for duration of the study. In the middle of the study a research coordinator will call the subjects to take questions/concerns and record adverse events. Lactulose breath test will be repeated, constipation questionnaire filled out, colon transit study performed.
16226419|NCT01190020|Drug|Lubiprostone Control|Colonic transit study performed and stool/symptom diaries will be reviewed. Eligible subjects will be given a lactulose breath test and randomized to Lubiprostone or placebo. Treatment group receives 24 mcg Lubiprostone twice daily and placebo group receives pills (identical in appearance to the study drug) for one month. Subjects will be asked to maintain a daily stool/symptom diary for duration of the study. In the middle of the study a research coordinator will call the subjects to take questions/concerns and record adverse events. Lactulose breath test will be repeated, constipation questionnaire filled out, colon transit study performed.
16226420|NCT01190007|Drug|Caduet|One Caduet tablet will be administered once daily after breakfast, in principle, for 52 weeks
16226421|NCT01189994|Procedure|Acupuncture|Needling of acupoints, some of them receiving electrostimulation
16226422|NCT01189994|Behavioral|Orientation|Orientation sessions focusing in fibromyalgia
16226423|NCT01189981|Behavioral|Lifestyle counseling|One health conversation at baseline
16226424|NCT01189981|Behavioral|eHealth intervention|SMS based encouragements to intensive exercise
16226425|NCT01189968|Drug|Demcizumab|The 6 subjects in the first cohort will receive demcizumab 5 mg/kg once every 3 weeks; the 6 subjects in the subsequent cohort will be treated with 10 mg/kg once every 3 weeks; and the 6 subjects in the final cohort will be treated with 15 mg/kg once every 3 weeks. A Data Safety Monitoring Board (DSMB) will review the data for the 6 subjects in each dose cohort after the last subject in that cohort has been on study for 56 days and then decide whether it is safe to escalate to the next highest dose cohort. Once the dose-escalation portion of the study has been completed, 14 additional subjects will be treated at the highest dose level that the DSMB deems as safe.
16226426|NCT01189955|Procedure|HS total thyroidectomy|In the HS group, using the new harmonic scalpel device Focus (Ethicon Endo Surgery, Cincinnati, OH, USA) was used for cutting and coagulation . For closure of and division of superior and inferior arteries and veins we set the instrument at a power 2 i.e. more coagulation. And when smaller vessels like capsule veins we set it to the level 5 i.e. more cutting The superior artery and vein was divided close to the gland to avoid damage to superior laryngeal nerve. And control of any bleeding from the bed using the active blade of harmonic. Finally we insert drain.
16226427|NCT01189955|Procedure|conventional total thyroidectomy|A prophylactic antibiotic in the form of a third-generation cephalosporin was administered 2 hours before the operation. The operation was performed with the patient in the supine position under general anesthesia with endotracheal intubation. A Kocher incision, was made at the lower neck crease two finger above suprasternal notch. In the conventional group, mono- and bipolar coagulation, as well as ligatures, were allowed.
16226428|NCT01189942|Drug|OMP-21M18|The first 6 participants will receive OMP21M18 2.5 mg/kg once every other week, the next 6 participants will receive 5 mg/kg once every other week, and the final 6 participants will receive 10 mg/kg once every other week. A Data Safety Monitoring Board (DSMB) will review the data for the 6 participants in each dose level after the last participant in that group has been treated for 56 days and decide whether it is safe to move up to the next highest dose level. After confirming the optimum dose, 14 additional participants will be treated at the highest dose level that the DSMB considers safe.
16226429|NCT01189929|Drug|Demcizumab|Up to 50 subjects will be enrolled at up to 8 centers in Australia, New Zealand, and Spain. Up to 28 days (4 weeks) prior to treatment you will undergo testing to determine your eligibility to take part in this study, and then if you are enrolled in the study you will receive intravenous (in the vein) infusions of the demcizumab administered once every 2 weeks, and gemcitabine and Abraxane® administered weekly for 3 weeks, out of every 4 weeks. After 9 weeks, you will undergo assessments to determine the status of your disease. If there is no evidence of progression of your disease or if your tumor is smaller, you will continue to receive one additional infusion of demcizumab, and you will continue to receive infusions of gemcitabine and Abraxane® once weekly for 3 consecutive weeks out of every 4 weeks until it has been shown that your cancer has progressed. You will undergo assessments every 8 weeks thereafter to determine the status of your disease.
16226430|NCT01189929|Drug|Abraxane®|Abraxane® which will be administered by IV infusion at a dose of 125 mg/m2 over 30 minutes once a week for 3 weeks in a row, followed by a week of rest.
16226431|NCT01189929|Drug|Gemcitabine|Gemcitabine will be administered intravenously over 30 minutes initially at a dose of 1000 mg/m2 once a week for 3 weeks in a row, followed by a week of rest. If you develop side effects during this time period, your physician may decide to hold or reduce the dose of gemcitabine.
16226432|NCT01189916|Procedure|Endoscopically assisted Appendectomy Surgery|Using endoscopic instruments a small incision will be made in the rectum wall and the endoscope will be advanced into the insufflated peritoneal cavity. At least one laparoscopic trocars will be placed through the abdominal wall for laparoscopic instrument insertion to manipulate and cut tissue. The flexible endoscope will provide visualization of the surgical field and flexible endoscopic instruments may be used to augment surgical manipulation with the laparoscopic instruments. The appendix will be removed through the anus. Endoscopic clips, sutures or tissue anchors (TAS)will be used to close the rectal access site.
16226433|NCT01189903|Drug|Regorafenib|
16226434|NCT01189890|Drug|sitagliptin phosphate|Sitagliptin tablets, orally, at a dose of 100 mg or 50 mg QD for 30 weeks. The dose level to be administered will depend on the participant's estimated glomerular filtration rate (eGFR), calculated at Visit 3 and may be adjusted as medically indicated during the study.
16226435|NCT01189890|Drug|Glimepiride|Glimepiride tablets, orally, starting at a dose of 1 mg QD, which may be gradually increased, as needed, to maximum dose of 6 mg QD for 30 weeks. The dose may also be decreased as medically indicated during the study.
16226436|NCT01189890|Drug|Placebo to Sitagliptin|Matching placebo tablets to sitagliptin to allow for blinding.
16226437|NCT01189890|Drug|Placebo to Glimepiride|Matching placebo tablets to glimepiride to allow for blinding.
16226438|NCT01189877|Procedure|Eppendorf hypoximeter|Patients consented to the protocol will proceed to their surgery date without any change in the standard preoperative period. After arriving in the operating room, the patient will undergo intravenous general anesthesia (or spinal/epidural anesthesia) by the anesthesiologist and will receive 40% oxygen. At this time, the principal investigator (along with the assistance of the operating surgeon and a member of the Department of Medical Physics) will use the Eppendorf hypoximeter to gather pO2 measurements. We anticipate that this will add no more than fifteen minutes to the planned procedure. Once the measurements are collected, the anesthesia will be adjusted as appropriate for the surgery and the procedure will continue as usual.
16226439|NCT01189864|Drug|Ciprofloxicin or Vigamox or other.|Ciprofloxicin or Vigamox or other to be used qid till epithelialized.
16226440|NCT01189864|Drug|Nonsteroidal (Acular, Acuvail, Voltaren Xibrom, etc)|Nonsteroidal (Acular, Voltaren Xibrom, etc) qid up to 5-10 days post-op
16226441|NCT01189864|Drug|Steroid (FML, Pred Forte, Flarex, etc.)|Steroid (FML, Pred Forte, Flarex, etc.) to be used qid to qd for 1-8 weeks.
16226442|NCT01189851|Device|Intraoperative Radiotherapy|The Axxent eBx™ System utilizes a miniaturized high dose rate (HDR) X-ray source to apply radiation directly to the cancerous tumor bed and provides brachytherapy when the physician chooses to deliver intracavitary or interstitial radiation to the surgical margins following lumpectomy for breast cancer.
16226443|NCT01189825|Behavioral|Exercise|Moderate to intense cardiovascular exercise on a treadmill for 20 minutes
16226444|NCT01189812|Drug|Lithium Carbonate|300 mg one time per day for 4 weeks
16226445|NCT01189812|Drug|Placebo|Take one time daily for 4 weeks
16226446|NCT01189812|Drug|Citalopram|All patients will be administered Citalopram 20 mg to to be taken once daily, by mouth for the duration of the double-blind treatment phase (4 weeks)
16226447|NCT01189799|Behavioral|Motivational therapy|Twelve, 60 minute weekly structured manualized therapy sessions.
16226448|NCT01189799|Other|Dual Recovery Anonymous/Treatment as usual|Twelve 60 minute weekly sessions of peer led 12-step Dual Recovery Anonymous group.
16226449|NCT01189786|Device|CliniMACS CD34 Reagent system|A special machine that separates out the donor cells that have been mixed with a special protein, CD34 antibody, that binds to the stem cells from the white blood cells.
16226965|NCT01185886|Other|laboratory biomarker analysis|
16226450|NCT01189773|Drug|ibuprofen and codeine|ibuprofen: 10 mg/kg (max = 600 mg), codeine: 1 mg/kg (max = 60 mg)
16226451|NCT01189760|Biological|onabotulinumtoxinA 24 U|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart.
16226452|NCT01189760|Biological|onabotulinumtoxinA 44 U|44 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart
16226453|NCT01189760|Drug|normal saline|Normal Saline injected into bilateral Crow's Feet Line and Frown Line areas per treatment. Patients will receive two treatments 4 months apart.
16226454|NCT01189747|Biological|onabotulinumtoxinA|24 units onabotulinumtoxinA (botulinum toxin Type A) total dose injected into bilateral Crow's Feet Line areas on Day 1
16226455|NCT01189747|Drug|normal saline|Injected into bilateral Crow's Feet Line areas on Day 1
16226456|NCT01189734|Procedure|laparoscopic common bile duct exploration|
16226457|NCT01189734|Procedure|laparoscopic cholecystectomy and intraoperative endoscopic sphincterotomy|
16226458|NCT01189721|Drug|propofol, sevoflurane|"Remifentanil will be infused intraoperatively at 0.2 ㎍/㎏/min (group1 and 2) group 1 (Active Comparator, sevoflurane)will be infused propofol intraoperatively.
~group 2(Experimental, propofol) will be inhaled sevoflurane intraoperatively."
16226459|NCT01189708|Device|Ultrapro® Mesh implantation|After the aortic procedure (aortic aneurysm repair) an Ultrapro absorbable mesh will be used for the wound closure of the abdominal wall using an onlay technique.
16226460|NCT01189708|Other|Standard wound closure|Abdominal closure will be performed with standard sutures without a mesh.
16226461|NCT01189695|Drug|Ritonavir-boosted lopinavir|Lopinavir/ritonavir 200/50 mg every 12 hours
16226462|NCT01189695|Drug|optimized background regimens (OBRs)|Optimized background regimens such as NRTIs, etravirine or raltegravir
16226463|NCT01189682|Procedure|Tegaderm, Tegaderm HP, Tegaderm CHG|dressings on catheters
16226464|NCT01189669|Dietary Supplement|LC n-3 PUFA (fish oil) Supplement|4 x 1g LC n-3 PUFA (fish oil)supplement containing 1.9g EPA and DHA given daily for 6 weeks
16226465|NCT01189669|Dietary Supplement|Placebo (olive oil) supplement|4 x 1g olive oil capsules were given daily for 6 weeks
16226466|NCT01189656|Biological|HBV DNA Vaccine|HBV DNA Vaccine, 1mg/ml/syringe, formulation
16226467|NCT01189643|Drug|irinotecan, temozolomide, and bevacizumab incorporated into an existing schedule of high dose alkylator|Two cycles of the investigational combination irinotecan, temozolomide and bevacizumab- will be given followed by conventional chemotherapy with a modified P6 approach and surgical local control. Completion of modified P6 chemotherapy will be followed by a second-look surgery.
16226468|NCT01189617|Device|Formula PD-F-7619|Off-White to Beige Lotion
16226469|NCT01189604|Drug|Placebo|Infusion of placebo, same infusion rates as for arm 2
16226470|NCT01189604|Drug|ICI35,868 (propofol)|Infusion of propofol: initiation with 0.17 mg/kg for 3 minutes followed by maintenance with 25 µg/kg/minute
16226471|NCT01189604|Drug|ICI35,868 (propofol)|Infusion of propofol: initiation with 0.33 mg/kg for 3 minutes followed by maintenance with 50 µg/kg/minute
16226472|NCT01189604|Drug|ICI35,868 (propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 3 minutes followed by maintenance with 75 µg/kg/minute
16226473|NCT01189604|Drug|ICI35,868 (propofol)|Infusion of propofol: initiation with 0.8 mg/kg for 3 minutes followed by maintenance with 120 µg/kg/minute
16226474|NCT01189604|Drug|ICI35,868 (propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 1 minutes followed by maintenance with 75 µg/kg/minute
16226475|NCT01189604|Drug|ICI35,868 (propofol)|Infusion of propofol: initiation with 0.5 mg/kg for 5 minutes followed by maintenance with 75 µg/kg/minute
16226476|NCT01189591|Device|Slow-wave deprivation|Using acoustic tones to suppress slow-wave sleep
16226477|NCT01189552|Behavioral|LETS ACT Behavioral Activation Treatment|LETS ACT is based on the empirically validated Behavioral Activation Treatment for Depression (BAT-D; Lejuez, Hopko, & Hopko, 2001). Treatment includes eight sessions over a four-week period and is provided in small group format, with each group consisting of 3-5 patients.
16226478|NCT01189552|Behavioral|Nondirective Therapy (NDT)|The purpose of Nondirective Therapy (NDT) is to provide group therapy interaction, allowing for the development of a close therapeutic relationship and a safe and accepting environment to facilitate change. NDT will be conducted as outlined by Crits-Cristoph (1997). That is, the therapist will create an accepting, nonjudgmental, empathic environment to continuously direct client attention to primary feelings, and to facilitate accepting of affective experience using supportive statements, reflective listening, and empathic communications. Patients will received NDT in a small group format (3-5 participants) and will meet over the course of 4 weeks.
16226479|NCT01189526|Drug|Ranibizumab|Ranibizumab 0.5mg Ranibizumab will be administered to patients as multiple intravitreal injections.
16226480|NCT01189526|Procedure|macular laser photocoagulation|Treatment may include both focal and grid therapy using the laser and contact lens of the investigator's choice.
16226481|NCT01189513|Drug|SCH 900105|10 mg/kg by vein every week on days 1, 8 and 15 of a 30 day cycle.
16226482|NCT01189500|Drug|Tamoxifen|Period 1-Tamoxifen 40mg on study day 1.
16226483|NCT01189500|Drug|Tamoxifen and Desvenlafaxine Succinate Sustained Release|Period 2-Desvenlafaxine SR 100mg on days 1-28 with coadministration of Tamoxifen 40mg on day 7.
16226484|NCT01189487|Drug|ampicillin sodium/sulbactam sodium|ampicillin sodium/sulbactam sodium is administered 12g/day (3 g four times a day) intravenously for 3 to 14 days
16226485|NCT01189474|Device|Blephasteam|Eye lid warming goggles
16226486|NCT01189461|Drug|pegaptanib sodium|Upon enrollment, all subjects will be treated in the study eye with pegaptanib sodium 0.3 mg at the investigators' discretion based on visual acuity assessment up to a maximum of 48 weeks. The minimum dosing interval between injections will be at least 6 weeks.
16226525|NCT01189201|Drug|BI 10773/linagliptin SID|medium single dose of mono components BI 10773/linagliptin
16226526|NCT01189201|Drug|BI 10773/linagliptin FDC|medium single dose of BI 10773/linagliptin FDC (Formulation A1) after high fat, high caloric meal
16226527|NCT01189188|Procedure|Artery puncture with ultrasound guidance|Ultrasound device will be used to locate artery for puncture.
16226528|NCT01189188|Procedure|Artery puncture without ultrasound guidance|Blood drawn from radial artery according to conventional procedure, without ultrasound guidance.
16226487|NCT01189448|Drug|Pyrimethamine/Sulfadiazine|"Pyrimethamine + sulfadiazine group : Pyrimethamine 50 mg once daily orally and sulfadiazine 1g tid. orally, with supplemental folinic acid 50 mg once a week.
~Follow-up includes clinical and biological tolerance, according to usual recommendations. Monthly fetal ultrasound is performed. Prenatal diagnosis with amniocentesis is offered after 18 weeks gestation, usually 4 weeks after the maternal infection.
~Treatment is be stopped or changed in case of toxicity. If prenatal diagnosis shows fetal infection with T. gondii, management is to be determined by the clinicians with the patient. If the prenatal diagnosis is negative the treatment can be stopped in order to reduce the risk of intolerance, providing that the mother receives at least 4 weeks of therapy."
16226488|NCT01189448|Drug|Spiramycine|"Spiramycin group : spiramycin 1g tid orally Follow-up includes clinical and biological tolerance, according to usual recommendations. Monthly fetal ultrasound is performed. Prenatal diagnosis with amniocentesis is offered after 18 weeks gestation, usually 4 weeks after the maternal infection.
~Treatment is be stopped or changed in case of toxicity. If prenatal diagnosis shows fetal infection with T. gondii, management is to be determined by the clinicians with the patient. If the prenatal diagnosis is negative the treatment is continued according to usual procedures"
16226489|NCT01189435|Drug|erlotinib|After baseline evaluation, patients will initiate treatment with erlotinib 150 mg daily, or at maximum previous tolerated dose. Initial response assessment will be done during the fourth week of therapy, during the eighth week of therapy, and then every 8 weeks thereafter. Patients will continue on therapy until disease progression by RECIST.
16226490|NCT01189422|Drug|teplizumab or placebo|infusion or injection
16226491|NCT01189409|Drug|PEG then Senna|Stepped bowel protocol with PEG for 3 weeks followed by senna for 3 weeks. Both active treatments accompanied by placebo of alternate (lactose powder).
16226492|NCT01189409|Drug|Senna then PEG|Stepped bowel protocol with senna for 3 weeks followed by PEG for 3 weeks. Both active treatments accompanied by placebo of alternate (lactose powder).
16226493|NCT01189396|Drug|A006|Albuterol DPI with 180 mcg Albuterol/inhalation
16226494|NCT01189396|Drug|Placebo DPI|Placebo DPI with 0 mcg Albuterol/inhalation
16226495|NCT01189396|Drug|Proventil-HFA|Albuterol MDI with 90 mcg Albuterol/inhalation
16226496|NCT01189383|Biological|IL15-DC Vaccine|Autologous dendritic cells manufactured with GM-CSF, IL15 and loaded with melanoma/HIV peptides and KLH; then activated with LPS and CD40 Ligand. Approximately 9 x 10^6 DCs will be injected (subcutaneously)total per vaccination visit. Patients will receive four vaccinations at weeks 0, 4, 8 and 12. At each scheduled vaccination the patient will receive a total of 3 injections, i.e., 3 mL injections at each of 3 anatomical locations.Injection sites are in upper and lower extremities. Subsequent DC injections will be rotated to different locations on the upper and lower extremities.
16226497|NCT01189370|Drug|sorafenib|"Dose Level:
~400mg twice daily, continuous.
~600mg twice daily, days 1-5 of each week.
~800mg twice daily, days 1-5 of each week."
16226498|NCT01189344|Drug|Levothyroxine|600 µg of oral levothyroxine(LT4. Blood samples were collected before and after LT4 administration
16226499|NCT01189331|Device|CT coronary angiography and computational fluid dynamics|Evaluate coronary blood flow dynamics by CT coronary angiography and computational fluid dynamics
16226500|NCT01189318|Drug|Quetiapine Fumarate Extended Release|Day 1 50mg, Day 2 50mg, Day 3 150mg, Day 4~28 50~150mg (increments and deduction of 50mg are allowed)
16226501|NCT01189305|Behavioral|Behavioral Couples Therapy|Behavioral Couples Therapy
16226502|NCT01189305|Behavioral|Individual Drug Counseling|Individual Drug Counseling
16226503|NCT01189292|Drug|Dexamethasone|8mg (2ml) of dexamethasone (Mephameson®) administered intravenously preoperatively before thyroid surgery
16226504|NCT01189292|Other|NaCl 0.9%|2ml of NaCl 0.9% administered intravenously preoperatively before thyroid surgery
16226505|NCT01189279|Drug|bimatoprost Formulation A|bimatoprost Formulation A applied topically to the scalp once daily on Day 1 and Days 4-17.
16226506|NCT01189279|Drug|bimatoprost Formulation B|bimatoprost Formulation B applied topically to the scalp once daily on Day 1 and Days 4-17.
16226507|NCT01189279|Drug|bimatoprost Formulation C|bimatoprost Formulation C applied topically to the scalp once daily on Day 1 and Days 4-17.
16226512|NCT01189253|Drug|doxorubicin hydrochloride|
16226513|NCT01189253|Drug|trabectedin|
16226514|NCT01189253|Other|laboratory biomarker analysis|
16226515|NCT01189253|Procedure|quality-of-life assessment|
16226516|NCT01189240|Drug|gamma-secretase/Notch signalling pathway inhibitor RO4929097|Given orally
16226517|NCT01189240|Biological|bevacizumab|Given IV
16226518|NCT01189240|Other|laboratory biomarker analysis|Correlative studies
16226519|NCT01189240|Other|pharmacological study|Correlative studies
16226520|NCT01189227|Procedure|Postoperative chemotherapy|Patients undergo hepatic resection. Beginning 31-56 days after surgery, patients receive mFOLFOX6 or FOLFIRI chemotherapy IV on day 1 over 3 hours. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats every 2 weeks for 12 cycles.
16226521|NCT01189227|Procedure|Perioperative chemotherapy|Patients receive mFOLFOX6 or FOLFIRI chemotherapy IV over 3 hours on day 1. Patients receive an additional dose of fluorouracil over 46 hours using a portable pump. Treatment repeats for every 2 weeks for 6 cycles. Patients then undergo hepatic resection. Beginning 31-56 days after surgery, patients receive an additional 6 cycles of mFOLFOX6 or FOLFIRI chemotherapy.
16226522|NCT01189214|Drug|Memantine|Add-on of memantine or placebo treatment will proceed in a double-blinded fashion for 12 weeks after adjusted methadone dose. During the study, we will evaluate treatment response and adverse effect from multiple dimensions to elucidate the therapeutic effect of add-on memantine on addictive behaviors. It will also explore the possible advantage of this treatment on social re-adaptation and psychopathogenesis of opioid dependence.
16226523|NCT01189201|Drug|BI 10773/linagliptin|medium single dose of BI 10773/linagliptin FDC (Formulation A1)
16226524|NCT01189201|Drug|BI 10773/linagliptin|medium single dose of BI 10773/linagliptin FDC (Formulation A3)
16226966|NCT01185886|Other|pharmacogenomic studies|
16226529|NCT01189175|Drug|BI 113823 + Ketokonazole|5 days ketokonazole with single oral dose of BI 113823 on day 3
16226530|NCT01189175|Drug|BI 113823|single oral dose
16226531|NCT01189162|Device|NIMV with SLE ventilator vs HFNC via Vapotherm|Nasal respiratory support for RDS
16226532|NCT01189149|Procedure|IV fluids|Infants will be allocated to IV fluids
16226533|NCT01189149|Procedure|Naso/oro gastric tube feedings|Infants will be allocated to naso/oro gastric tube feedings
16226534|NCT01189136|Device|PTNS Active Treatment|34 gauge needle inserted 3cm above the medial ankle, and cables are connected to the PTNS stimulator device. Stimulation is provided, per manufacturer directions, over a 30-minute treatment period.
16226535|NCT01189136|Other|Sham treatment|34 gauge needle inserted 3cm above the medial ankle, but nonconductive cables are connected, so that no electrical stimulation is applied, over a 30-minute treatment period
16226536|NCT01189123|Biological|High dose influenza vaccine Sanofi-Pasteur|High dose influenza vaccine Sanofi-Pasteur at standard dosing intramuscular injection
16226537|NCT01189123|Biological|fluzone by sanofi pasteur|standard dose fluzone
16226538|NCT01189110|Device|Auriculotherapy using TENS unit Stim Flex 400A|Although the mechanism of action of auriculotherapy is not well understood, the dominant scientific theory for how traditional acupuncture procedures works has suggested possible neurophysiologic and neurochemical pathways that may explain its effectiveness for treating specific disorders
16226539|NCT01189097|Drug|Dextromethorphan|Subjects who have not used opioid for at least one week before baseline evaluation will take one-week placebo for the wash-out period first and then will be categorized into the opioid free group. The subjects of the opioid using group will be assigned randomly into the following six groups: 1) Methadone + DM 60mg; 2) Methadone + DM 120mg; 3) Methadone + Placebo; 4) Methadone + DM 60mg + motivation and cognitive behavior therapy; 5) Methadone + DM 120mg + motivation and cognitive behavior therapy; 6) Methadone + Placebo + motivation and cognitive behavior therapy. The opioid free group will be 1) DM 30mg; 2) DM 60 mg; 3) Placebo.
16226540|NCT01189097|Drug|Dextromethorphan|Subjects who have not used opioid for at least one week before baseline evaluation will take one-week placebo for the wash-out period and then randomly assigned into six groups: 1) Methadone + DM 60mg; 2) Methadone + DM 120mg; 3) Methadone + Placebo; 4) Methadone + DM 60mg + motivation and cognitive behavior therapy; 5) Methadone + DM 120mg + motivation and cognitive behavior therapy; 6) Methadone + Placebo + motivation and cognitive behavior therapy. The opioid free group will be 1) DM 30mg; 2) DM 60 mg; 3) Placebo. If the subjects of the opioid free group suffer from relapses and begin to use heroin, they will receive methadone treatment. The dosage of methadone will be increased or decreased maximal 5 mg each time as necessary.
16226541|NCT01189084|Biological|Observational|Measure anti-Amyloid-beta antibody in serum during 24-26 weeks extension period to 48 weeks (after first vaccine treatment).
16226542|NCT01189071|Drug|Darifenacin|an M3 selective anticholinergic medication. M3 muscarinic receptors are felt to be related to bladder and ureteral contractility. The ureteral and bladder spasms related to ureteral stents are felt to be due to inappropriate contractions. By using a selective M3 receptor, it is felt that there will be fewer side effects. Participants will be placed on the standard 15 mg oral daily dosage for 3 days prior to the stent being placed, day 3 being the am of the surgery.
16226543|NCT01189058|Procedure|Repetitive Transcranial Magnetic Stimulation (rTMS)|TMS can affect discrete functional ares of motor cortex offering non-invasive, painless mapping and modulation of motor systems. Inhibitory rTMS (1Hz)has been shown to safely lower motor cortex excitability in normal patients as well as adult and pediatric stroke patients. Dose is 20 minutes per day (1200 stimulations) x 10 days administered over the non-lesioned M1.
16226544|NCT01189058|Procedure|Constraint-induced movement therapy (CIMT)|CIMT uses gentle restraint of the fully functional upper extremity to promote functional gains in the affected upper extremity. CIMT is well established to be safe and is likely effective in children with hemiplegic cerebral palsy, many of whom have perinatal stroke as studied here. A custom-fitted, bivalved cast is applied and worn for >90% of waking hours for the 2 weeks of active treatment according to protocol with daily assessments for comfort.
16226545|NCT01189045|Behavioral|Aerobic Exercise Program|The AEROBIC PROGRAM will be the Experimental arm of this trial. It will be a structured, progressive aerobic training program that will be 6 months in duration. Classes will be held 3 times / week, for 1 hour / session.
16226546|NCT01189045|Behavioral|Non-aerobic Exercise Program|The BALANCE AND FLEXIBILITY (non-aerobic) PROGRAM will be the Active Comparator arm of this trial. It will be comprised of upper and lower body stretching, or balance activities, yoga- or Tai Chi-style classes. This program will be 6 months in duration. Classes will be held 3 times / week, for 1 hour / session.
16226547|NCT01189032|Drug|DE-089 ophthalmic solution|
16226548|NCT01189032|Drug|DE-089 ophthalmic solution|
16226549|NCT01189032|Drug|Placebo ophthalmic solution|
16226550|NCT01189019|Drug|ranibizumab|2mg intravitreal injection monthly
16226551|NCT01189019|Drug|ranibizumab|2mg monthly x 3 doses, then as needed based on recurrence of activity on OCT
16226552|NCT01189006|Drug|Dextromethorphan|Add-On double-blind study treatment commenced at randomization for 11 weeks while patients were continuing open-label risperidone. Randomization was immediately preceded by a one week open-label Risperidone-Only Treatment period. Patients who were receiving antipsychotics medication(s) at screen other than risperidone alone was withdrawn from previous non-risperidone medication(s) and at the same time commenced risperidone in titrating doses over a week. This Antipsychotic Switch-Over Period occurred between Screen and Risperidone-Only Treatment period. Patients remained hospitalized for at least during the Risperidone-Only treatment Period and first week of Add-On treatment Period.
16226553|NCT01188993|Combination Product|early septic shock|Each patient will be assessed by both the transpulmonary thermodilution and Transesophageal Echocardiography.
16226554|NCT01188967|Drug|GSK598809|Oral dose of 60 mg/day for a treatment period six weeks
16226555|NCT01188967|Drug|Placebo|Placebo
16226556|NCT01188954|Drug|doxycycline|50 ml/mg
16226557|NCT01188954|Other|No intervention|Normal Saline/Water
16226623|NCT01188525|Drug|10 parents drugs adminstration|A single and concomittant administration of 10 parent drugs will be performed: Acetaminophene, cafeine, dextrometorphan, digoxin, memantine,midazolam, omeprazole, repaglinide, rosuvastatine, tolbutamide.
16226624|NCT01188512|Biological|BPZE1|Individuals will be vaccinated once intranasally with the designated dose of BPZE1 Dose 2 x 0.1 mL (0.1 mL per nostril).
16226558|NCT01188941|Behavioral|Health System Navigator|Subjects will be enrolled prior to an HIV test. Following TB screening, HIV infected subjects will meet with the health systems navigator who will administer a brief strengths-based interview. During this interview the participant and navigator will identify barriers to HIV and/or TB care and the resources and strengths that will be most helpful in overcoming these barriers. The health system navigator will stay in contact with participants for the next 4 months using phone calls and SMS on a standardized schedule. During the phone contacts the health system navigator will assess where the participant is on the care pathway. If the participant has not completed a step in his/her HIV or TB care, the health system navigator will help the participant draw on strengths identified in the initial interview and overcome any obstacles hindering him/her from accessing care.
16226559|NCT01188928|Drug|Calcipotriol plus betamethasone|Topical suspension once daily for up to 8 weeks.
16226560|NCT01188928|Drug|Betamethasone-17,21-dipropionate|Topical suspension once daily for up to 8 weeks.
16226561|NCT01188928|Drug|Calcipotriene|Topical suspension once daily for up to 8 weeks.
16226562|NCT01188928|Drug|Topical suspension vehicle|Topical suspension once daily for up to 8 weeks.
16226563|NCT01188915|Procedure|intensive screening|Each year, women will have breast cancer detection based on mammography, echography and RMI. Questionaries will also be completed.
16226564|NCT01188902|Dietary Supplement|walnut|walnut consumption 48 g/d
16226565|NCT01188889|Drug|RAD001|"Dosing schedule of RAD001 for the Phase I portion:
~Regimen 1. 5.0 mg q72 hours (400 mg QD); Regimen 2. 5 mg q48 hours (400 mg QD); Regimen 3. 5.0 mg q day (400 mg QD); Regimen 4. 7.5 mg PO q day (400 mg QD."
16226566|NCT01188889|Drug|Imatinib|Imatinib will be given continuously at a fixed daily dose of 400 mg once daily.
16226567|NCT01188876|Drug|carboplatin|Given intravenously on Day 1 of each 28-day cycle
16226568|NCT01188876|Drug|pralatrexate|Given intravenously on Day 1 and Day 15 of each 28-day cycle.
16226569|NCT01188876|Drug|Folic Acid|Given orally on a daily basis starting 7 days before the first dose of pralatrexate and continuing until 30 days after the last dose of pralatrexate.
16226570|NCT01188876|Drug|Vitamin B12 Injection|Given vitamin B12 injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10 weeks after the first dose of pralatrexate.
16226571|NCT01188863|Drug|300 mg LX4211 (150 mg tablets)|Single oral dose of two 150 mg tablets LX4211
16226572|NCT01188863|Drug|300 mg LX4211 (50 mg tablets)|Single oral dose of six 50 mg tablets LX4211
16226573|NCT01188863|Drug|300 mg LX4211 (liquid)|Single 30 mL dose of liquid oral solution LX4211 (10 mg/mL)
16226574|NCT01188850|Biological|VGX-3100|DNA plasmid delivered via IM injection + electroporation using CELLECTRA device
16226575|NCT01188837|Other|Full Kinetic Chain Manipulative Therapy|"Treatment will focus on restoring knee flexion and extension by lesser grades of mobilization and patellar mobilization along with careful high velocity low amplitude axial elongation of the knee joint.
~Additionally, manipulative therapy will be applied where needed to the full kinetic chain using diversified techniques, such as HVLA manipulation or mobilization.
~This group will receive a total of 6 treatments over a 3 week period. Outcome measures will be taken at baseline, prior to the 4th treatment and at the one week follow-up. A 3 month follow-up will be done by mail, phone or email."
16226576|NCT01188837|Other|Full Kinetic Chain Rehabilitation|"Rehabilitative therapy includes exercises, focused soft tissue treatment and stretch to the knee and the full kinetic chain where needed based upon functional assessment. Also included; patient advice, education and home exercise recommendations for managing their KOA.
~This group will receive a total of 6 treatments over a 3 week period. Outcome measures will be taken at baseline, prior to the 4th treatment and at the one week follow-up. A 3 month follow-up will be done by mail, phone or email.
~The rehabilitative therapy group will be required to attend the initial treatment/training, the 4th visit and 1 week follow-up. Treatments 2, 3, 5 and 6 are considered optional; they may be done at home"
16226577|NCT01188837|Other|Full Kinetic Chain Manipulative Therapy with Rehabilitation|"This arm is a combination of the manipulative therapy arm and the rehabilitative therapy arm.
~This group receives 6 treatments over a 3 week period with a one week follow-up on site and a 3 month follow-up by mail, phone or email."
16226578|NCT01188824|Drug|Cilostazol|100 mg, bid p.o.
16226579|NCT01188824|Other|placebo|1 tablet, bid
16226580|NCT01188811|Drug|lipoic acid|1200 mg taken by mouth daily starting on day one of the study and ending on the last day of study participation.
16226581|NCT01188811|Drug|Placebo|The placebo comparator will be taken by mouth daily starting on day one of the study and ending on the last day of study participation
16226582|NCT01188798|Drug|Methotrexate|Participants will be randomized to receive either methotrexate (MTX) or pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor.
16226583|NCT01188798|Drug|Pentostatin|Participants will be randomized to receive either methotrexate (MTX) or pentostatin for graft-versus-host disease (GVHD) prophylaxis after receiving an allogeneic bone marrow transplant from an HLA-matched related or unrelated donor.
16226584|NCT01188785|Drug|siG12D LODER|"Phase 0 - subjects diagnosed with an operable adenocarcinoma of the pancreas will have 8 siG12D LODER placed in tumor. The siG12D LODER will be placed in the subject's tumor using an EUS biopsy needle.
~Phase I - subjects diagnosed with locally non-operable advanced adenocarcinoma of the pancreas. These subjects will have one of three different siG12D LODERs dose levels placed in tumor - Either 1 siG12D LODER, 2 siG12D LODERs or 8 siG12D LODERs. The siG12D LODER/s will be placed in the subject's tumor using an EUS biopsy needle."
16226585|NCT01188772|Drug|Sofosbuvir|Sofosbuvir tablets were administered orally once daily.
16226586|NCT01188772|Drug|Placebo to match sofosbuvir|Placebo tablets to match sofosbuvir were administered orally once daily.
16226587|NCT01188772|Drug|PEG|Pegylated interferon alfa-2a (PEG) 180 μg was administered once weekly by subcutaneous injection.
16226588|NCT01188772|Drug|RBV|Ribavirin (RBV) was administered as a tablet orally according to package insert dosing recommendations (Genotype 1: < 75kg = 1000 mg and ≥ 75 kg = 1200 mg; Genotype 2/3: 800 mg).
16226625|NCT01188512|Biological|Placebo|Individuals will get placebo once intranasally. Dose 2 x 0.1 mL (0.1 mL per nostril).
16226626|NCT01188499|Drug|Birinapant|
16226627|NCT01188486|Radiation|Stereotactic Body Radiation Therapy (SBRT)|Standard of care diagnostic radiotherapy procedure
16226967|NCT01185873|Drug|danoprevir|Repeated oral doses
16226589|NCT01188759|Drug|Voriconazole|"For Children aged 2-11 years and adolescents aged 12-14 years weighing <50 kg:
~Voriconazole 9 mg/kg IV load q12h x 24h, then 8 mg/kg IV q12h, with option to switch to oral voriconazole at 9 mg/kg q12h (maximum 350 mg) after 7 days.
~For adolescents aged 12-17 years, excluding 12-14-year-olds weighing <50kg:
~Voriconazole 6 mg/kg IV q12h x 24h, then 4 mg/kg IV q12h, with an option to switch to oral voriconazole at 200 mg q12h after 7 days.
~Voriconazole therapy is to be given for 6-12 weeks."
16226590|NCT01188759|Drug|Anidulafungin|"Anidulafungin 3 mg/kg IV load q24h x 24h (maximum 200 mg), then 1.5 mg/kg q24h (maximum 100 mg).
~Anidulafungin therapy is to be given for 2-4 weeks in combination with voriconazole."
16226591|NCT01188759|Drug|Voriconazole|"For Children aged 2-11 years and adolescents aged 12-14 years weighing <50 kg:
~Voriconazole 9 mg/kg IV load q12h x 24h, then 8 mg/kg IV q12h, with option to switch to oral voriconazole at 9 mg/kg q12h (maximum 350 mg) after 7 days.
~For adolescents aged 12-17 years, excluding 12-14-year-olds weighing <50kg:
~Voriconazole 6 mg/kg IV q12h x 24h, then 4 mg/kg IV q12h, with an option to switch to oral voriconazole at 200 mg q12h after 7 days.
~Voriconazole therapy is to be given for 6-12 weeks."
16226592|NCT01188746|Behavioral|McGill Quality of Life Questionnaire and the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire|Participants will be interviewed twice (if they chose to participate in the qualitative portion) and complete instruments at three time points: 1) immediately prior to the procedure, 2)within seven days after the procedure, preferably prior to discharge, and 3) three weeks after their catheter placement.
16226593|NCT01188733|Drug|Long acting octreotide 10mg|Comparison of different doses
16226594|NCT01188733|Drug|Long acting Octreotide 30mg|Comparison of drug doses
16226595|NCT01188733|Drug|Saline|Comparison of drug doses
16226596|NCT01188720|Behavioral|Physical activity|30 minutes of moderate to intense physical activity including strength training and cardiovascular activity.
16226597|NCT01188707|Drug|Belinostat and Erlotinib|"The design of the first phase is a 3 +3 phase I trial. The Belinostat dose will start at 500 mg and will be increased with 250 mg until a maximum dose of 1500 mg, administered daily in 2/3 weeks. Each patient will at the same time receive 150 mg of Erlotinib daily continously.
~When the patient is enrolled at one dose level, there will be no further dose escalation for that individual patient.
~3 patients will be treated at each dose level."
16226598|NCT01188694|Drug|Psychotherapy plus Methylene Blue, USP|This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, 260 mg of methylene blue, USP will be given.
16226599|NCT01188694|Behavioral|Psychotherapy plus Placebo|This treatment involves daily visits with a therapist for 50 to 60 minutes for a total of six sessions. At the end of each session, capsules containing the placebo will be given.
16226600|NCT01188694|Behavioral|Delayed Psychotherapy|Individuals must wait approximately five to six weeks to start treatment. They will come in for two check-in appointments before starting treatment. Treatment will consist of ten twice-weekly psychotherapy sessions (90-120 min each session).
16226601|NCT01188681|Drug|TRU-016 and bendamustine|TRU-016 at 20 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
16226602|NCT01188681|Drug|Bendamustine|Bendamustine at 70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
16226603|NCT01188681|Drug|15 mg/kg TRU-016 and bendamustine|TRU-016 at 15 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
16226604|NCT01188681|Drug|20 mg/kg TRU-016 and bendamustine|TRU-016 at 20 mg/kg, weekly by IV infusion x 2 cycles, then every 14 days x 4 cycles PLUS bendamustine (70 mg/m2 by IV infusion on Days 1 and 2 of every 28-day cycle, for 6 cycles
16226605|NCT01188668|Drug|Aripiprazole|Period 1-Aripiprazole 5mg on study day 1.
16226606|NCT01188668|Drug|Aripiprazole + desvenlafaxine succinate sustained release|Period 2-Desvenlafaxine SR 100mg on days 1-19 with coadministration of Aripiprazole 5mg on day 7.
16226607|NCT01188655|Drug|Enbrel|"The patients will be treated in accordance with the requirements of the labeling of Enbrel® in Austria. The dosage and duration of therapy is to be determined by the physician to meet the patients' individual needs for treatment.
~To record complete dosing information, initial dose will be documented at baseline and any change will be documented with date, dose and reason at the subsequent visits."
16226608|NCT01188642|Behavioral|obesity lifestyle intervention|physical activity 5 times per week + nutrition education
16226609|NCT01188629|Behavioral|Safety Training|IT intervention focuses on safety in the home.
16226610|NCT01188629|Behavioral|Personal Health Partner and Counseling (PHP+C)|The PHP intervention will have three primary functional areas: 1) pre-visit assessment and counseling; 2) EHR data exchange with clinician review; and 3) post-visit follow-up, re-assessment, and counseling.
16226611|NCT01188616|Behavioral|Telephone Linked Care-HEAT (TLC-HEAT)|A primary care intervention linked with Telephone Linked Care-HEAT (TLC-HEAT), and delivered through an electronic health record (EHR). The HEAT system will guide children in the early stages of overweight toward healthy weight management and assist the child's parent(s) and primary care provider (PCP) to support the child's efforts.
16226612|NCT01188603|Drug|flibanserin 100 mg dose every evening|all subjects receive flibanserin
16226613|NCT01188590|Device|TOSCA 500 monitor|transcutaneous ear lobe probe that monitors pulse rate, oxygen saturation and carbon dioxide levels
16226614|NCT01188577|Drug|Epinephrine Inhalation Aerosol, HFA|10 inhalations of epinephrine inhalation aerosol, 125 mcg/inhalation
16226615|NCT01188577|Drug|Epinephrine Inhalation Aerosol|Epinephrine Inhalation Aerosol, 220 mcg/ inhalation, 10 inhalations
16226616|NCT01188564|Drug|rhC1INH|One i.v. injection of rhC1INH at the dose of 50 U/kg, for patients up to 84 kg; one i.v. injection of rhC1INH at the dose of 4200U (2 vials) for patients of 84 kg body weight or greater.
16226617|NCT01188564|Drug|Placebo (Saline)|One i.v. injection of saline (NaCl 0.9% w/v), equivalent in volume to the active treatment
16226618|NCT01188551|Drug|Dexmedetomidine|dexmedetomidine (1 µg/kg) will be administered intranasally
16226619|NCT01188551|Drug|Fentanyl|fentanyl (2 µg/kg) will be administered intranasally
16226620|NCT01188551|Drug|Midazolam|Sedative given pre-op.
16226621|NCT01188538|Drug|Epiduo gel|Once daily application on the face in the evening for 12 weeks
16226622|NCT01188538|Drug|BPO|Once daily application on the face in the evening for 12 weeks
16226628|NCT01188486|Radiation|Computed Tomography (CT)|For each participant, 3 chest CT scans will be obtained, 1 before and 2 after interstitial injection of the water-soluble contrast
16226629|NCT01188486|Device|Cyberknife|Linear accelerator for producing high energy x-rays for radiation therapy.
16226630|NCT01188486|Device|Trilogy|Linear accelerator for producing high energy x-rays for radiation therapy.
16226631|NCT01188486|Device|True Beam|Linear accelerator for producing high energy x-rays for radiation therapy.
16226632|NCT01188486|Drug|Iohexol|Aqueous solution of a nonionic, water-soluble radiographic contrast medium in prefilled cartridges with a molecular weight of 821.14 (iodine content 46.36%), available at 140, 180, 240, 300, and 350 mgI/mL.
16226633|NCT01188486|Drug|Iodixanol|Aqueous solution of a nonionic, water-soluble, dimeric, isosmolar, radiographic contrast medium with a molecular weight of 1550.20 (iodine content 49.1%), available in 2 concentrations, (270 mgI/mL and 320 mgI/mL.
16226634|NCT01188473|Other|NPPV plus standard of care|Patients in the NPPV group were fitted with a nasal mask with gel seals (Comfortgel Masks, Respironics) and placed on the BiPAP Machine (Vision Bipap, Respironics). To optimize patient cooperation, the mask was initially applied manually to the patient's face. After a short adaptation period, it was firmly applied on the face by head straps to minimize air leak without causing skin injury. Pressures were initially set low for comfort and acceptance while being placed on the machine. The inspiratory positive airway pressure (IPAP) was gradually increased to 8 cm H2O in order to achieve a tidal volume of 6-9 ml/kg and the end expiratory positive airway pressure (EPAP) to 5 cm H 2O. These settings remained unchanged throughout the study period.
16226635|NCT01188460|Behavioral|Self-help manual for insomnia|Implementation of chapters of self-help manual at home, and completion of sleep diary in terms of time in bed, hours of sleep, time to fall asleep, number of awakenings, and sleep quality
16226636|NCT01188460|Behavioral|Sleep diary|
16226637|NCT01188447|Procedure|Canadian C-Spine Rule|Paramedics will apply a validated decision rule (the Canadian C-spine Rule) to determine whether or not immobilization is required for trauma patients being transported to the emergency department.
16226638|NCT01188434|Behavioral|ITSAN|integrated behavioral intervention for substance abuse, parenting skills, and basic needs
16226639|NCT01188434|Behavioral|Services as Usual|Services as usual referred by child welfare
16226640|NCT01188421|Drug|Buprenorphine/naloxone|up to 8/2 mg Sublingual (SL) per day
16226641|NCT01188421|Drug|Clonidine|up to 0.8 mg per day (oral)
16226642|NCT01188421|Drug|Tramadol ER|up to 600 mg per day
16226643|NCT01188408|Drug|Liposome Entrapped Docetaxel (LE-DT)|110 mg/m2 IV (in vein) on day 1 of each 21 day cycle, 6 cycles or until disease progression or unacceptable toxicity
16226644|NCT01188382|Procedure|CSF dynamic investigation|
16226645|NCT01188369|Drug|levosimendan|Intravenous infusion, 0,1ug/kg/min, duration 4 hours prior to operation and until the end of operation.
16226646|NCT01188369|Drug|placebo drug|Intravenous infusion, colour identical to levosimendan
16226647|NCT01188343|Biological|Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus|0.5 mL each; Subcutaneous (SC)
16226648|NCT01188343|Biological|Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus|0.5 mL each, Subcutaneous (SC)
16226649|NCT01188343|Biological|Japanese encephalitis chimeric virus: Measles, mumps, and rubella live attenuated virus|0.5 mL each, subcutaneous (SC)
16226650|NCT01188330|Behavioral|WITH Comprehensive Geriatric assessment|"Each month after randomization, a nurse practitioner will systematically review the intervention plan.
~In case of hospitalisation, the nurse will go and meet the patient and his care giver to check each point of the intervention plan. If an action has not been done, a new proposal will be made to the patient. If the patient is at home or in institution, the nurse practitioner will call the patient and /or his care giver for the same purpose"
16226651|NCT01188330|Behavioral|Conventional|no Comprehensive Geriatric assessment
16226652|NCT01188317|Drug|aleglitazar|repeated daily doses
16226653|NCT01188317|Drug|placebo|repeated daily doses
16226654|NCT01188317|Drug|ibuprofen|repeated daily doses
16226655|NCT01188304|Drug|aleglitazar|repeated daily doses
16226656|NCT01188304|Drug|aspirin|repeated daily doses
16226657|NCT01188304|Drug|placebo|repeated daily doses
16226658|NCT01188278|Drug|Imatinib|Drug being observed but not provided
16226659|NCT01188265|Drug|Valproate|
16226660|NCT01188265|Drug|Dextromethorphan 60 mg per day|VPA plus dextromethorphan 60 mg per day
16226661|NCT01188265|Drug|Placebo|VPA plus placebo
16226662|NCT01188265|Drug|Dextromethorphan 30 mg|VPA & Dextromethorphan 30 mg per day
16226663|NCT01188252|Drug|Roniciclib (BAY1000394)|Oral administration twice daily in a 3 days on / 4 days off schedule. Starting dose will be 0.3 mg corresponding to approximately 0.005 mg/kg and dose will be escalated dependent on any dose limiting toxicities.
16226664|NCT01188226|Device|Denture teeth|Denture teeth made of nano hybrid composite material
16226665|NCT01188213|Dietary Supplement|Methylsulfonylmethane (MSM)|
16226666|NCT01188200|Other|Experimental nutritional formula #M979|One two hundred and forty mL serving at test time, taken orally
16226667|NCT01188200|Other|Standard food|Standard meal prior to test time
16226668|NCT01188187|Drug|Custirsen|
16226669|NCT01188187|Drug|Docetaxel|
16226670|NCT01188187|Drug|Prednisone|
16226671|NCT01188187|Drug|Dexamethasone|Dexamethasone 8 mg by mouth twice a day for 3 days beginning one day before docetaxel administration to reduce the incidence and severity of hypersensitivity reactions and fluid retention.
16226672|NCT01188174|Drug|Clofarabine|The present protocol aims to test the strategy of an early Reduced Intensity Conditioning (RIC) allo-SCT; in combination with a sequential preparative regimen for allo-SCT (Clofarabine, Intermediate dose Ara-C chemotherapy, followed by RIC with Cyclophosphamide, IV Busulfan and ATG; and delayed prophylactic infusion of donor lymphocytes (DLI) will be able to improve the outcome of patients with primary treatment failure AML.
16226673|NCT01188161|Device|Rotating Chair|Subjects will be spun in rotating chair
16226674|NCT01188148|Drug|Memantine|5 mg per day of memantine
16226675|NCT01188148|Drug|Placebo|
16226887|NCT01186445|Drug|saline solution|3 ml of saline solution , intracoronary injection during reperfusion
16226888|NCT01186432|Drug|PDS 1.0|
16226676|NCT01188135|Behavioral|Interactive voice messaging or Interactive voice messaging + psycho ed materials|Interactive voice telephone messages reminder participants to continue to take their antidepressive medications
16226677|NCT01188122|Device|AnapnoGuard 100|Respiratory guard system during mechanical ventilation
16226678|NCT01188109|Drug|Gemcitabine|"Standard of care chemotherapy and dosage
~Dose - 1000 mg/m²
~Schedule - Days 1 and 15; Q 28 days"
16226679|NCT01188109|Drug|Cisplatin|"Dose - 50 mg/m²
~Schedule - Days 1 and 15; Q 28 days"
16226680|NCT01188096|Drug|Poly ICLC|Children will receive poly-ICLC 20 mcg/kg twice weekly IM (using Monday/Wednesday schedule if possible). The first 2 doses will be administered in the clinic under supervision.
16226681|NCT01188083|Dietary Supplement|Fructose Drink|Fructose Based beverage 8 oz
16226682|NCT01188083|Dietary Supplement|Glucose Drink|Glucose Based beverage 8 oz per drink x 3 per day x 4 weeks
16226683|NCT01188070|Behavioral|Usual Care|Educational materials
16226684|NCT01188070|Behavioral|Psycho-education|Educational group sessions
16226685|NCT01188070|Behavioral|Psycho-education plus physical exercise|Psychoeducation intervention plus an individualized exercise program
16226686|NCT01188057|Drug|ALPRAZOLAM ORALLY DISINTEGRATING TABLETS, 2.0 MG|A: Experimental Subjects received Purepac Pharmaceutical Co. formulated products under non-fasting conditions
16226687|NCT01188057|Drug|NIRAVAM TM 2 mg orally disintegrating tablets, single dose|B: Active comparator Subjects received Schwarz Pharma Inc. formulated products non-under fasting conditions
16226688|NCT01188031|Drug|ALPRAZOLAM ORALLY DISINTEGRATING TABLETS, 2.0 MG|A: Experimental Subjects received Purepac Pharmaceutical Co. formulated products under fasting conditions
16226689|NCT01188031|Drug|NIRAVAM TM 2 mg orally disintegrating tablets, single dose|B: Active comparator Subjects received Schwarz Pharma Inc. formulated products under fasting conditions
16226690|NCT01188018|Behavioral|Brief Advice (BA)|Participants in this arm will receive a single session of brief advice. A counselor will briefly discuss the risks associated with smoking.
16226691|NCT01188018|Behavioral|Motivational Interviewing (MI)|Subjects will receive 4 counseling sessions (over 18 weeks) in which their thoughts about their smoking will be discussed. Two of these counseling sessions will be performed in person (weeks 0 and 12) and the remaining two will be over the phone(weeks 6 and 18).
16226692|NCT01188018|Behavioral|Health Education (HE)|Subjects will receive 4 counseling sessions (over 18 weeks)in which they will receive educational information about the risks of smoking and the benefits of quitting. Two of these counseling sessions will be performed in person (weeks 0 and 12) and the remaining two will be over the phone (weeks 6 and 18).
16226693|NCT01188005|Device|n-CPAP|administration of continuous positive airway pressure through a nasal device
16226694|NCT01188005|Device|Oxygen supplementation|Oxygen supplementation (3L) through nasal spectacles
16226695|NCT01188005|Drug|Vitamin A, Vitamin C, Vitamin E, Allopurinol, N-Acetylcysteine|Vitamin A 50,000 IU, Vitamin C 1000 mg , Vitamin E 200 mg, Allopurinol 600 mg, N-Acetylcysteine 2 g. Duration is set for 60 days
16226696|NCT01187992|Drug|Atorvastatin|80 mg/day
16226697|NCT01187979|Behavioral|Cash incentives|Cash incentives paid to learners for reaching pre-determined milestones
16226698|NCT01187979|Behavioral|Life skills curriculum|Standard department of education lifeskills curriculum
16226699|NCT01187966|Drug|Safinamide|
16226700|NCT01187966|Drug|Safinamide|
16226701|NCT01187966|Drug|Placebo|
16226702|NCT01187953|Drug|Prograf (tacrolimus)|Administered per current product labeling
16226703|NCT01187953|Drug|LCP-Tacro|Tacrolimus, once-per-day The initial dose of 0.17 mg/kg will be administered orally in the morning (before noon) within 24 hours following transplantation. Subsequent doses will be adjusted according to whole blood tacrolimus trough levels.
16226704|NCT01187940|Behavioral|PEGASUS|PEGASUS - a psychoeducational group intervention with parallel parent and child sessions.
16226705|NCT01187927|Biological|Cervarix®|Administered according to the prescribing information in the locally approved label by the authorities.
16226706|NCT01187901|Drug|Erlotinib|Tarceva oral tablets are conventional, immediate-release tablets containing erlotinib as the hydrochloride salt. Erlotinib(75mg)will be taken once daily for six months in combination with sulindac.
16226707|NCT01187901|Drug|Sulindac|Sulindac is a non-steroidal, anti-inflammatory indene derivative designed for the treatment of arthritic conditions. For this study, sulindac (150mg) will be taken twice daily in combination with erlotinib
16226708|NCT01187901|Drug|Placebo A|Erlotinib (Tarceva) will provide a 25 mg identical placebo. This will be provided by the Division of Cancer Prevention at the NIH who will receive the drug and placebo from the manufacturer, OSI/Genentech. Dosage for Placebo A will be 75 mg a day for 6 months.
16226709|NCT01187901|Drug|Placebo B|Sulindac will be encapsulated in 150 mg doses along with an identical encapsulated Placebo B. One 150 mg capsules of Placebo B will be taken twice per day with meals (breakfast and supper).
16226710|NCT01187888|Drug|Rasagiline|tablet once daily 1 mg 1 year
16226711|NCT01187888|Drug|Sugar pill|tablet once daily one year
16226712|NCT01187875|Dietary Supplement|Placebo- Fiber free control|Dextrin control administered in a muffin treatment.
16226713|NCT01187875|Dietary Supplement|Hi-maize resistant starch 9g|9g Hi-maize resistant starch administered in a muffin treatment.
16226714|NCT01187875|Dietary Supplement|Novalose 330 resistant starch 9g|9g Novalose 330 resistant starch administered in a muffin treatment.
16226715|NCT01187875|Dietary Supplement|4.5g Hi-maize resistant starch and 4.5g Novalose 330|4.5g Hi-maize and 4.5g Novalose 330 in a muffin treatment.
16226716|NCT01187862|Drug|caffeine, efavirenz, losartan, omeprazole, metoprolol, chlorzoxazone and midazolam|
16226717|NCT01187849|Drug|Metformin|Volunteers will be given Metformin or placebo for 1 month, once daily.
16226718|NCT01187849|Drug|Placebo|Volunteers will be given Metformin or placebo for 1 month, once daily
16226719|NCT01187836|Drug|TRV120027|Dose range (starting at 0.1 mcg/kg/min) of TRV120027 administered for 14 hours.
16226720|NCT01187836|Drug|Placebo|Placebo administered for 14 hours.
16226721|NCT01187823|Device|Adaptive servo ventilation|Nocturnal use of Adaptive servo ventilation
16226722|NCT01187823|Device|Nocturnal oxygen|Nocturnal use of oxygen
16226723|NCT01187810|Drug|Fenretinide|925 mg/m2 IV continuous infusion X 5 days for 6 cycles. Dose escalation will occur on a 3X3 basis.
16226724|NCT01187810|Drug|Cytarabine|dosing depending on age - will be administed intrathecally for all CNS negative subjects on day 0 and 15 of course 1, then on day 8 of each remaining cycle for CNS negative AML. For CNS positive ALL, NHL, and AML, will be administered alone on day 0 for and in combination with methotrexate and hydrocortisone on day 8, 15, 22 of cycle 1 and repeated on day 8 of each remaining cycle
16226725|NCT01187810|Drug|Methotrexate|Dose depends on subject age - for CNS positive patients, will be given in combination with cytarabine and hydrocortisone on days 8, 15, and 22 during course 1. For courses 2-6, will be administered intrathecally on day 8 for CNS negative ALL and NHL. For patients who are CNS positive, it will be given in combination with cytarabine and hydrocortisone on day 8 of courses 2-6.
16226726|NCT01187797|Other|Emotional stimulation|Increase of the physical correlates of an emotion
16226727|NCT01187784|Behavioral|Coping Cat cognitive-behavioral therapy for anxious youth|Manualized, empirically supported CBT treatment for anxious youth
16226728|NCT01187771|Procedure|Laparoscopic Gastric Banding|Those randomized to surgery would meet with the bariatric surgeon and the dietitian during the 3 month weight management period and based on insurance requirements, would undergo LGB surgery after 3 months of weight management. PAP therapy would be utilized for the 3 week peri-operative period (1 week prior to 2 weeks post-operatively) given evidence that this might reduce peri-operative respiratory complications. Routine surgical follow-up will occur 2 weeks post-operatively and then every 4-6 weeks to assess weight loss trajectory and adjust the band as needed.
16226729|NCT01187771|Procedure|Continuous Positive Airway Pressure|Participants randomized to the CPAP arm will undergo a CPAP titration within 2 weeks of enrollment unless a split-night study was already performed as part of their diagnostic polysomnogram (PSG) providing a reliable CPAP therapeutic pressure. As soon as an appropriate pressure is identified, CPAP therapy will begin with routinely scheduled follow-up visits to maximize CPAP adherence. All participants will be offered a 12 month supervised weight loss program in addition to OSA-specific therapy.
16226730|NCT01187758|Behavioral|Workshops and focus group meetings|Multifacet intervention that includes: Guideline preparation and implementation, preparing clinic campaign, improving knowledge about Ab resistance and diagnosis of respiratory infections
16226731|NCT01187745|Other|CT Scan followed by ultrasound|A limited U/S is performed after the CT scan which is ordered by the Emergency Department physician.
16226732|NCT01187732|Device|Washing without water|The experimental intervention is 'washing without water' and consists of disposable washing cloths made of a mix of soft synthetic fibers, saturated with a no rinse, quickly vaporizing skin cleaning and caring lotion.
16226733|NCT01187719|Drug|phenytoin|phenytoin 184 mg (2 tablets of 92mg) OD at onset of labour and continue for seven days
16226734|NCT01187693|Other|shoe lift|shoe lift for balancing the heights of bilateral pelvis of participants with leg length discrepancy during standing
16226735|NCT01187680|Device|Spraygel|
16226736|NCT01187680|Device|Control|Good surgical technique, no adhesion barrier
16226737|NCT01187654|Biological|AC133|intra coronary injection of bone marrow derived AC133+ cells
16226738|NCT01187654|Biological|MNC|intra coronary injection of bone marrow derived MNC
16226739|NCT01187654|Biological|CONTROL|autologous serum injection
16226740|NCT01187628|Drug|Fosrenol (Lanthanum Carbonate, BAY77-1931)|Daily dose: 750-2250mg/day,(270-750mg each 3 times a day) for 52 weeks.
16226741|NCT01187615|Drug|Regorafenib (BAY73-4506) - sequential / Cisplatin / Pemetrexed|In Part A of this trial, regorafenib will be administered in a sequential dosing with a seven day wash out period before the next infusion of pemetrexed and cisplatin. Regorafenib will be administered at a dose of 160 mg qd from Day 2 to Day 14 followed by a 7 days break. Pharmacokinetics of regorafenib will be assessed on Day 14 of Cycle 1 and Day 1 of Cycle 2.
16226742|NCT01187615|Drug|Regorafenib (BAY73-4506) - continuous / Cisplatin / Pemetrexed|In Part B of this trial, regorafenib will be administered continuously from Day 1 to Day 21. Only in Cycle 1, regorafenib dosing will start on Day 2 in order to assess the pharmacokinetics of pemetrexed and cisplatin without concomitant regorafenib dosing. Pharmacokinetics of regorafenib will be assessed on Day 21 of Cycle 1 and on Day 1 of Cycle 2.
16226743|NCT01187589|Device|Pulsehaler|
16226744|NCT01187589|Drug|Nebulizer & Albuterol 0.5ml|Albuterol aerosolized by a nebulizer
16226745|NCT01187576|Behavioral|Multi-professional team intervention with PAR, lifestyle brochure|Multi-professional team intervention with PAR, lifestyle brochure
16226746|NCT01187576|Behavioral|Ordinary recommendations on health behaviours, lifestyle brochure|Ordinary recommendations on health behaviours, lifestyle brochure
16226747|NCT01187550|Drug|Recombinant human growth hormone (r-hGH)|Recombinant human growth hormone (r-hGH) administered at dose of 0.033 milligram/kilogram (mg/kg) body weight (0.1 International Unit [IU]/kg body weight) per day by subcutaneous injection.
16226748|NCT01187537|Procedure|Continuous Femoral Nerve Block|20mls of 0.25% Bupivacaine with 1/400,000 adrenaline (2.5mcg/ml) If catheter localized to < 1.0mA, 0.1mS with patella twitch, start Bupivacaine 0.125% 4ml/hr. If unable to get twitch through catheter in final location or twitch at current ≥ 1.0m/A, start Bupivacaine 0.125% 6ml/hr.
16226749|NCT01187511|Drug|GSK561679|Verucerfont is a corticotropin releasing hormone receptor 1 (CRF1) antagonist.
16226750|NCT01187511|Drug|Placebo|Placebo is an inactive tablet design to look exactly like GSK561679
16226751|NCT01187498|Behavioral|Behavioral training|Comprehensive behavioral training program using delayed voiding, urge suppression techniques, pelvic floor muscle training, and monitoring with bladder diaries. Treatment is implemented by a nurse practitioner in 4 clinic visits over 8 weeks.
16226752|NCT01187498|Drug|Oxybutynin chloride, extended-release|Individually titrated, extended-release oxybutynin chloride, initiated at 10 mg, fluid management handout, and monitoring with bladder diaries. Treatment is implemented by a nurse practitioner in 4 clinic visits over 8 weeks.
16226753|NCT01187485|Drug|Androderm® 2.5mg|Subjects will be asked to replace the study drug patch every 24 hours at night following the written and verbal instructions you will receive. The study drug patch should be placed over a small amount of a steroid cream on the skin to reduce irritation.
16226754|NCT01187485|Drug|Androderm® 5.0mg|Subjects will be asked to replace the study drug patch every 24 hours at night following the written and verbal instructions you will receive. The study drug patch should be placed over a small amount of a steroid cream on the skin to reduce irritation.
16226889|NCT01186419|Drug|SPD602 (FBS0701, SSP-004184)|Oral FBS0701 taken one time daily for up to 96 weeks.
16226755|NCT01187485|Drug|Androderm® 7.5mg|Subjects will be asked to replace the study drug patch every 24 hours at night following the written and verbal instructions you will receive. The study drug patch should be placed over a small amount of a steroid cream on the skin to reduce irritation.
16226756|NCT01187459|Dietary Supplement|Vitamin D|10 ug/day Vitamin D, taken for 6 months.
16226757|NCT01187459|Dietary Supplement|Vitamin D|50 ug/day Vitamin D, taken for 6 months.
16226758|NCT01187446|Radiation|Total skin electron beam therapy (TSEBT)|TSEBT is administered as 12 Gy fractionated at 2 grey (Gy)/cycle (each cycle requiring 2 days of treatment); 4 days each week; for 3 weeks.
16226759|NCT01187446|Drug|Vorinostat|Starting doses of is vorinostat 400 mg/day, continuing for 8 weeks.
16226760|NCT01187433|Biological|Live, attenuated, recombinant dengue serotype 1 , 2, 3 , and 4 virus|0.5 mL, Subcutaneous (SC)
16226761|NCT01187433|Biological|NaCl 0.9%|0.5 mL, Subcutaneous
16226762|NCT01187433|Biological|Tetanus toxoid, reduced diphtheria toxoid, acellular pertussis vaccine adsorbed|0.5 mL, Intramuscular
16226763|NCT01187433|Biological|Meningococcal A+C vaccine|0.5 mL, Intramuscular
16226764|NCT01187407|Drug|LY2216684|
16226765|NCT01187407|Drug|Placebo|
16226766|NCT01187407|Drug|SSRI|Participants should have been on their SSRI for at least 6 weeks prior and were to continue on their stable dose throughout the study
16226767|NCT01187381|Drug|Trastuzumab|Trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines
16226768|NCT01187368|Device|EVAHEART Left Ventricular Assist System (LVAS)|Three-hundred and ninety-nine (399) subjects will be enrolled and randomized in a 2:1 assignment to receive EVA2 or the comparator device, HeartMate 3.
16226769|NCT01187368|Device|HeartMate 3|Three-hundred and ninety-nine (399) subjects will be enrolled and randomized in a 2:1 assignment to receive EVA2 or the comparator device, HeartMate 3.
16226770|NCT01187355|Device|FID 114675A Multi-Purpose Disinfecting Solution (MPDS)|Investigational multi-purpose disinfecting solution used by subjects as specified in use instructions provided for the care of study contact lenses, 30 days.
16226771|NCT01187355|Device|renu fresh Multi-Purpose Solution (MPS)|Commercially available multi-purpose solution used by subjects as indicated for care of study contact lenses, 30 days.
16226772|NCT01187355|Device|Contact lenses|Contact lenses per subject's habitual brand and power worn for 30 days on a daily wear basis.
16226773|NCT01187329|Other|hyperinsulinemic normoglycemic clamp (HNC)|Prior to anesthetic induction, a baseline blood glucose value will be obtained, followed by an insulin infusion of 5 mU.Kg-1.min-1. When blood glucose is <110 mg/dL, a variable continuous infusion of glucose (dextrose 20%) supplemented with potassium (40 mEq/L) and phosphate (30 mmol/L) is administered to preserve normoglycemia (80-110 mg/dL). The glucose infusion is titrated to target glucose levels by checking blood glucose every 5 - 15 min with Accu-Check (Roche Diagnostics, Switzerland) glucose monitor. At sternal closure, insulin infusion is decreased to 1 mU/Kg/min. On admission to the ICU, insulin treatment follows the ICU protocol. The dextrose infusion is slowly weaned off over 2 - 4 hrs maintaining blood glucose > 80 mg/dL. Arterial blood glucose is measured every 30 - 60 min for 2 hrs, then, as stated in ICU protocol.
16226774|NCT01187329|Other|control group|Baseline arterial blood glucose will be obtained before anesthetic induction. Repeat measurements are performed every 30-90 min. Glucose >150 on CPB will receive insulin according to intraoperative protocol. After surgery, insulin is given according to ICU protocol. Target glucose < 180 mg/dL.
16226775|NCT01187316|Device|Transcutaneous electrical nerve stimulation|Sensors were positioned on anterior temporal and masseter muscles bilaterally, and the stimulation was used for 20 minutes at 150 Hz and 100 µs of pulse width; intensity was adjusted individually.
16226776|NCT01187316|Other|Physiotherapy|Massage and stretching of the anterior temporal and masseter muscle were performed by an experienced professional for 20 minutes.
16226777|NCT01187303|Drug|Ofatumumab|300 mg/m2 d1 week 1 1000mg/m2 d1 week 2-8
16226778|NCT01187290|Radiation|neoadjuvant chemoradiotherapy|Radiotherapy (3 weeks after last chemotherapy administration) 44 Gy in 22 fractions concomitant boost technique in 3 weeks
16226779|NCT01187277|Behavioral|conventional therapy|conventional therapy means: 50 min individual physiotherapy and 60 min individual occupational therapy per work day (5x per week)for four consecutive weeks
16226780|NCT01187277|Device|conventional plus robotic gait assisted therapy|individual physiotherapy +individual occupational therapy+ robotic gait assisted therapy
16226781|NCT01187264|Drug|Methotrexate|once weekly for a total duration of 12 weeks or earlier till patient achieves PASI 75
16226782|NCT01187238|Drug|cisplatin|in experimental arm, the eligibility patients will be received the same radiotherapy as radical radiotherapy alone group, and also will received concurrent chemotherapy with the regimen of cisplatin 40mg/m2, weekly,from week 1 to week 7
16226783|NCT01187225|Drug|Fibrinogen concentrate|In this arm, children (< 18 year-old)undergoing cardiac surgery with pump will receive fibrinogen concentrate (60 mg/Kg) if they present clinically significant bleeding associated to low levels of fibrinogen (< 1g/L) or TEG < 7 mm
16226784|NCT01187225|Drug|Cryoprecipitate|In this arm, children (< 18 year-old)undergoing cardiac surgery with pump will receive cryoprecipiate (10 ml/Kg) if they present clinically significant bleeding associated to low levels of fibrinogen (< 1g/L) or TEG < 7 mm
16226785|NCT01187212|Drug|Capecitabine/Cisplatin + Sorafenib|Capecitabine 800 mg / m² po bid (D1-14) Cisplatin 60 mg / m² IV Day 1 Sorafenib 400 mg p.o. bid continuous dosing
16226786|NCT01187212|Drug|Capecitabine/Cisplatin|Capecitabine 1000 milligram (mg) / m² po bid (D1-14) Cisplatin 80 mg / m² IV Day 1
16226787|NCT01187199|Drug|Temsirolimus|Starting dose 12.5 mg by vein given on day 1, 8, and 15 of a 21 day cycle.
16226788|NCT01187199|Drug|Bevacizumab|Starting dose 5 mg/kg given by vein on day 1 of a 21 day cycle.
16226789|NCT01187199|Drug|Paclitaxel|Starting dose 30 mg/m2 given by vein on day 1 of a 21 day cycle.
16226790|NCT01187199|Drug|Sorafenib|Starting dose 200 mg by mouth daily for a 21 day cycle.
16226791|NCT01187199|Drug|Carboplatin|Starting dose AUC 2 by vein on day 1 of a 21 day cycle.
16226792|NCT01187186|Drug|ASP1941|oral
16226890|NCT01186406|Drug|Gliadel|Patients will have 1-8 wafers of Gliadel inserted at the time of surgical resection.
16226891|NCT01186406|Radiation|Radiation Therapy|At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy.
16226793|NCT01187160|Procedure|Transoral robotic surgery (TORS)|The da Vinci® Robotic Surgical System (Intuitive Surgical, Inc., Sunnyvale, CA) is a manual image-guided surgery system that is computer enhanced rather than computer guided robotic surgery in which the surgeon programs the computer to do the surgery and the robot does the surgery (also known as a milling device). Use of the da Vinci® Robotic Surgical System in the aforementioned configuration in fact facilitates an exact translation of the surgeons hand and finger movements at the console to precise and tremor-free movements of the arms and instruments.
16226794|NCT01187147|Dietary Supplement|green tea extract|Green tea extract capsule, equivalent to 450 ml 2% Green tea containing 540mg EGCG/day
16226795|NCT01187134|Behavioral|Change Management|Hospitals have to create local change teams which are supported and trained by the study center. Local awareness of the staff is increased by PowerPoint presentations, posters, and brochures. The change teams receive monthly information about their quality indicator (duration until antimicrobial therapy). Anonymous comparison to other hospitals is possible (Benchmarking). Hospitals are visited three times a year to discuss progress of quality. In case of failure to improve, the change team is supported with specific tools for change management such as SWOT-analysis or resistance radar.
16226796|NCT01187108|Drug|N-acetylcysteine|NAC 600 mg oral once daily
16226797|NCT01187108|Drug|Acetazolamide|Acetazolamide 250 mg oral once daily
16226798|NCT01187108|Drug|Placebo pills|1 (or 2 in the placebo group) empty gel capsules
16226799|NCT01187095|Behavioral|Expressive writing|3 consecutive days of writing
16226800|NCT01187095|Behavioral|Active ctrl|Control
16226801|NCT01187082|Behavioral|bladdertraining in groups|Cognitive training in groups of 4 patients at hospital by a continence nurse in 3 sessions (1 hour)over a period of 1 month. Follow up after 1 month. During all 2 month the patient has selfinitiatied daily training with a pocket bladder schedule.
16226802|NCT01187082|Behavioral|bladdertraining individually|Cognitive training individually at hospital by a continence nurse in 3 sessions (1 hour)over a period of 1 month. Follow up after 1 month. During all 2 month the patient has selfinitiatied daily training with a pocket bladder schedule.
16226803|NCT01187069|Behavioral|Training course for practice nurses in autonomy support|An interactive course consisting of 4X4 hours education in autonomy support over a 6 months period. The main-components in the course are 1) communication skills, 2) introduction to patient work-sheets and 3) a quick up-to-date knowledge about treatment recommendations of type 2 diabetes. Furthermore, the nurses in the intervention-practices receive a half an hour support-visit 4-5 months after the end of the course.
16226804|NCT01187056|Behavioral|Training programme|2 x 2 hours of training (workshops)
16226805|NCT01187043|Drug|Proellex|1 capsule 1x/day of 1 mg(ARM1), 3 mg(ARM2), 6 mg(ARM3), 9 mg(ARM4) or 12 mg(ARM5)
16226806|NCT01187017|Drug|Cyclophosphamide|60 mg/kg
16226807|NCT01187017|Drug|Fludarabine|125 mg/m squared
16226808|NCT01186991|Drug|Onartuzumab|Onartuzumab will be administered as intravenous (IV) infusion at a dose of 10 milligrams per kilogram (mg/kg) on Day 1 and Day 15 of each 28-day cycle. The dose of onartuzumab will be based on the participant's weight at screening and will remain the same throughout the study.
16226809|NCT01186991|Drug|Bevacizumab|Bevacizumab will be administered as IV infusion at a dose of 10 mg/kg on Day 1 and Day 15 of each 28-day cycle. The dose of bevacizumab will be based on the participant's weight at screening and will remain the same throughout the study.
16226810|NCT01186991|Drug|Paclitaxel|Paclitaxel will be administered as IV infusion at a dose of 90 milligrams per meter-squared (mg/m^2) on Day 1, Day 8, and Day 15 of each 28-day cycle.
16226811|NCT01186991|Drug|Bevacizumab Placebo|Placebo matching to bevacizumab will be administered as IV infusion on Day 1 and Day 15 of each 28-day cycle.
16226812|NCT01186991|Drug|Onartuzumab Placebo|Placebo matching to onartuzumab will be administered as IV infusion on Day 1 and Day 15 of each 28-day cycle.
16226813|NCT01186978|Radiation|Radiation Therapy|1.5-2 Gy per fraction to a total dose of 19.8-20 Gy with radiation given 5 days/week
16226814|NCT01186965|Behavioral|eHealth program in the Virtual Environment (VE) platform Second Life|determine the feasibility and acceptability of an eHealth program that provides diabetes education and self-management support.
16226815|NCT01186952|Behavioral|Caloric restriction|The caloric restriction diet will follow the Canadian Diabetes Association guidelines and be nutritionally balanced with a reduced total fat as well as saturated content.
16226816|NCT01186952|Behavioral|Diet intervention and structured exercise training program|Participants will follow the diet intervention previously described and a supervised physical activity program. The supervised exercise training sessions will take place three times a week for 4 months. Each session will last 1hour and will include aerobic exercise and resistance training. The aerobic training program will be treadmills intervals exercise at 50-70 % of heart rate reserve(HRR) the first month and 85-90% of HRR from the second to the fourth month. The resistance training programme will consist of two to three sets of 12 repetitions of the following exercises: leg press, chest press, lat pulldown, shoulder press, biceps curl, triceps extension.
16226817|NCT01186939|Drug|Azacitidine|Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m^2/day.
16226818|NCT01186926|Device|HGNS Treatment|The Apnex Hypoglossal Nerve Stimulation (HGNS) System is an implanted medical device that is designed to prevent the tongue from blocking the airway during sleep. It is fully automatic and can be implanted during a simple surgical procedure. After it is implanted, the device is programmed to meet the unique needs of each patient. The device is on when the patient is sleeping, and off when the patient is awake.
16226819|NCT01186900|Procedure|ultrasound-guided needle aspiration|one time drainage at time of randomization
16226820|NCT01186887|Drug|Celecoxib|The treatment group will receive 400 mg Celecoxib p.o. preoperatively and the control group will receive a placebo between 1 and 3 hours pre-op, when other standard medications are administered. The treatment group will receive 200 mg of Celecoxib orally twice per day post operatively, for a duration of 5 days based on dosing protocols shown to be well tolerated and effective in treating pain following ambulatory surgery. The control group will receive a 5 day supply of placebo pills. Both groups will receive standard post surgical narcotic prescription (Oxycodone IR 5 - 10 mg po qid prn and acetaminophen 325 - 650 mg PO qid prn
16226968|NCT01185873|Drug|ritonavir|Repeated oral doses
16226969|NCT01185860|Drug|danoprevir|oral doses
16226821|NCT01186887|Drug|Placebo|The treatment group will receive 400 mg Celecoxib p.o. preoperatively and the control group will receive a placebo between 1 and 3 hours pre-op, when other standard medications are administered. The treatment group will receive 200 mg of Celecoxib orally twice per day post operatively, for a duration of 5 days based on dosing protocols shown to be well tolerated and effective in treating pain following ambulatory surgery. The control group will receive a 5 day supply of placebo pills. Both groups will receive standard post surgical narcotic prescription (Oxycodone IR 5 - 10 mg po qid prn and acetaminophen 325 - 650 mg PO qid prn
16226822|NCT01186861|Drug|OSI-906|Tablet administered with food and with up to 200 mL of water
16226823|NCT01186861|Drug|erlotinib|Tablet administered at least 2 hours after food with up to 200 mL of water
16226824|NCT01186861|Drug|placebo|Tablet administered at least 2 hours after food with up to 200 mL of water
16226825|NCT01186848|Device|Combination treatment|The contralateral side received the combination of micro-focused ultrasound treatment and 1550nm-fractionated laser alternatively every 2 weeks for a total of 4 treatments with site-match control area of baseline striae on each side.
16226826|NCT01186848|Device|1550-nm erbium-doped fractionated laser|Each side of thigh (or abdomen) was randomized to receive 1550nm-fractionated laser treatment every 2 weeks for a total of 4 treatments on one side.
16226827|NCT01186835|Procedure|Combination Botulinum Toxin A and Hyaluronic Acid|One side of subject's face will randomly be assigned combination treatment.
16226828|NCT01186835|Procedure|Botulinum Toxin A|Other side of subjects face with receive Botulinum Toxin A treatment alone.
16226829|NCT01186822|Device|Lung Flute|Used twice daily
16226830|NCT01186809|Biological|in vitro expanded Cytokine Induced Killer (CIK) cells|Three infusions of donor Cytokine Induced Killer (CIK) cells will be administered according to a dose escalating program, starting 3 weeks after second Donor Lymphocyte Infusions (DLI). Cytokine Induced Killer administrations will be separated by 3 weeks intervals
16226831|NCT01186796|Drug|Fulvestrant|"Secretagogue combinations are assigned in randomized double-blind order within-subject to include the following four conditions:
~(i)L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by 5 mL bolus of NS at 1000 h; (ii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH and Ghrelin (both at dose of 0.3 mcg/kg bolus i.v.) at 1000 h; (iii) L-arginine (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by GHRH (0.3 μg/kg bolus i.v.) at 1000 h; (iv) L-arginine infusion (30 gm i.v. over 30 min from 0930 h to 1000 h) followed by Ghrelin (0.3 μg/kg bolus i.v.) at 1000 h.
~**Ghrelin dosage is based on 70 kg subject.Total exposure of Ghrelin will be 42 mcg total dose for 2 subject visits (21 mcg per visit)."
16226832|NCT01186783|Drug|ivabradine|"Patients in the ivabradine treatment arm receive an additional enteral preparation (orally, via nasogastric tube or percutaneous endoscopic gastrostomy-probe) of ivabradine for 4 days.
~Day 1 and 2:
~5,0 mg ivabradine b.i.d. if heart rate ≥60bpm (acute renal failure: ≥70bpm)
~Day 3 and 4:
~5,0 mg ivabradine b.i.d. if 60bpm≥heart rate<90bpm (acute renal failure: 70bpm≥heart rate <90bpm
~7,5 mg ivabradine b.i.d. if heart rate ≥90bpm"
16226833|NCT01186770|Drug|Methylnaltrexone|Methylnaltrexone will be administered as per the dose and schedule specified in the respective arms.
16226834|NCT01186770|Drug|Placebo|Placebo matching to methylnaltrexone will be administered as per the schedule specified in the respective arms.
16226835|NCT01186757|Drug|PF-03715455|PF-03715455 1.6 mg BID
16226836|NCT01186757|Drug|PF-03715455|PF-03715455 4mg BID
16226837|NCT01186757|Drug|PF-03715455|PF-03715455 10 mg BID
16226838|NCT01186757|Drug|Placebo|Placebo
16226839|NCT01186744|Drug|CP-690,550|10 mg of CP-690,550 oral BID or placebo oral BID, as appropriate based on treatment withdrawal/retreatment design
16226840|NCT01186744|Drug|CP-690,550|10 mg oral BID
16226841|NCT01186744|Drug|CP-690,550|5 mg of CP-690,550 oral BID or Placebo oral BID, as appropriate based on treatment withdrawal/retreatment design
16226842|NCT01186744|Drug|CP-690,550|5 mg oral BID
16226843|NCT01186731|Drug|Liposome Entrapped Docetaxel (LE-DT)|110 mg/m2 (IV)in vein on day 1 of each 21 day cycle , 6 cycles, until progression or unacceptable toxicity
16226844|NCT01186705|Drug|MK-2206|Patients will receive MK-2206 orally in a once weekly dose of 200mg. There will be no dose escalation. Patients will be treated until disease progression or unacceptable side effects.
16226845|NCT01186692|Device|Melody® Transcatheter Pulmonary Valve|Transcatheter Pulmonary Valve replacement Transcatheter valve implantation into a RVOT conduit in patients with complex congenital heart defects where the conduit has become dysfunctional and where the patient needs invasive intervention.
16226846|NCT01186679|Procedure|laminectomy|surgical laminectomy with glial scar resection
16226847|NCT01186679|Procedure|Intrathecal|direct into the CSF through lumbar puncture
16226848|NCT01186666|Device|Coronary intervention using IVUS-VH & FDG PET-MDCT|All the patients will undergo percutaneous coronary intervention of culprit vessels after imaging of the entire coronary tree (culprit and non-culprit lesions) using intravascular ultrasound with radiofrequency data analysis (IVUS-VH). Before discharge, fluorodeoxyglucose positron emission tomography combined with multidetector computed tomography (FDG PET-MDCT) of the carotid arteries and the thoracic aorta, along with MDCT coronary angiography, will be performed and a blood sample will be obtained for subsequent measurements of emerging or new biomarkers.
16226849|NCT01186666|Device|Coronary intervention using IVUS-VH & FDG PET-MDCT|All the patients will undergo percutaneous coronary intervention of culprit vessels after imaging of the entire coronary tree (culprit and non-culprit lesions) using intravascular ultrasound with radiofrequency data analysis (IVUS-VH). Before discharge, fluorodeoxyglucose positron emission tomography combined with multidetector computed tomography (FDG PET-MDCT) of the carotid arteries and the thoracic aorta, along with MDCT coronary angiography, will be performed and a blood sample will be obtained for subsequent measurements of emerging or new biomarkers.
16226850|NCT01186653|Drug|budesonide / formoterol|budesonide / formoterol, 400 micrograms/9 micrograms one IH bd
16226851|NCT01186653|Drug|fluticasone/salmeterol|fluticasone/salmeterol, 250 micrograms/25 micrograms two puffs bd, dose as per NICE guidelines
16226892|NCT01186406|Drug|Avastin|"Avastin (10 mg/kg) will be given every 14 days, and will begin a minimum of 42 days post-operatively.
~Beginning two to three weeks after the last radiation therapy, but not greater than eight weeks, subjects will be treated with Avastin (10mg/m2) every 14 days."
16226970|NCT01185860|Drug|peginterferon alfa-2a [Pegasys]|180 mcg sc once weekly
16226971|NCT01185860|Drug|placebo|oral doses
16226852|NCT01186640|Drug|Fludarabine, Mitoxantrone, Cyclophosphamide and Alemtuzumab|"I. First treatment phase: Chemoimmunotherapy A-FMC
~Alemtuzumab:
~Cycle 1+2:
~10 mg s.c., days 1-3
~Cycle 3+4:
~CR: 10 mg s.c., days 1-3 PR/SD: 30 mg s.c., days 1-3 Fludarabine: 20 mg/m2 i.v., days 1-3 Mitoxantrone: 6 mg/m2 i.v., day 1 Cyclophosphamide: 200 mg/m2 i.v., days 1-3 Repeat day 29, maximum 4 cycles. II. Second treatment phase: Maintenance-treatment with 30mg Alemtuzumab s.c. The maintenance therapy will start one month after the Final Staging and will be administered monthly during the first six months plus once in month 10 and 13."
16226853|NCT01186640|Drug|Alemtuzumab|maintenance with Alemtuzumab following a induction with combined immunochemotherapy consisting of Fludarabine, cyclophosphamide, mitoxantrone and alemtuzumab
16226854|NCT01186614|Device|Automated CPR|Automated CPR utilised by paramedics to facilitate CPR during transport to hospital
16226855|NCT01186614|Device|ECMO|Insertion of peripheral VA ECMO
16226856|NCT01186614|Procedure|Coronary angiography|Coronary angiography and intervention where necessary will be performed following ECMO insertion
16226857|NCT01186614|Procedure|Therapeutic Hypothermia|Paramedic initiated hypothermia with intravenous ice cold fluid and then continued for 24 hours (33 degrees)
16226858|NCT01186601|Drug|PET tracer (BAY94-9392)|A radioactive dose of 300 MBq of the study drug with a total quantity of </= 0.1 mg will be administered as slow intravenous bolus injection over up to 60 seconds
16226859|NCT01186588|Drug|Canagliflozin|One 300-mg dose of canagliflozin on Day 1
16226860|NCT01186575|Other|Text Message|Context-sensitive text messages are sent to men after undergoing circumcision
16226861|NCT01186562|Drug|Sitagliptin|100 mg PO daily
16226862|NCT01186562|Drug|Placebo|Placebo
16226863|NCT01186549|Drug|Ephedrine 30microgram/kg|"Patients were randomly allocated to one of 5
~groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected"
16226864|NCT01186549|Drug|lidocaine0.5mg/kg -ephedrine30 micrograms/kg|"Patients were randomly allocated to one of 5
~groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected"
16226865|NCT01186549|Drug|ephedrine 70 microgram/kg|"Patients were randomly allocated to one of 5
~groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected"
16226866|NCT01186549|Drug|lidocaine 0.5mg/kg|"Patients were randomly allocated to one of 5
~groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected"
16226867|NCT01186549|Drug|normal saline 2ml|"Patients were randomly allocated to one of 5
~groups (33 patients per group): lidocaine 0.5 mg/kg(L) ,ephedrine 30micrograms/kg (E30)ephedrine 70micrograms/kg(E70),lidocaine0.5mg/kg -ephedrine30 micrograms/kg(LE) or 2ml saline (S)intravenously.participants in each group receive a single dose of the intervention treatment only.After one minute propofol 2 mg/kg into a dorsal hand vein was injected"
16226868|NCT01186536|Dietary Supplement|Whey Protein supplement|40 g/day of whey protein will be consumed in 2 doses for 9 months (Study duration)
16226869|NCT01186536|Dietary Supplement|Soy Protein Supplement|40 g/day of soy protein will be consumed in 2 doses for 9 months (Study duration)
16226870|NCT01186536|Dietary Supplement|Carbohydrate supplement|40 g/day of maltodextrin will be consumed in 2 doses for 9 months (Study duration)
16226871|NCT01186523|Other|Long Term Energy Balance|To see if there is a variance in weight loss and energy balance between men and women with similar energy expenditure over an extended period of time.
16226872|NCT01186510|Procedure|lung perfusion|see literature of proceeding
16226873|NCT01186510|Procedure|no lung perfusion|see literature of proceeding
16226874|NCT01186497|Drug|Rabeprazole sodium: Treatment E|The contents of 2 rabeprazole sprinkle capsules equivalent to 10 mg rabeprazole sodium mixed with a tablet vehicle suspension (Treatment E) on Day 1.
16226875|NCT01186497|Drug|Rabeprazole sodium: Treatment C|The contents of 2 rabeprazole sprinkle capsules equivalent to 10 mg rabeprazole sodium sprinkled on 1 tablespoon of applesauce (Treatment C) on Day 1.
16226876|NCT01186497|Drug|Rabeprazole sodium: Treatment D|The contents of 2 rabeprazole sprinkle capsules containing 10 mg rabeprazole sodium mixed with 5 mL (1 teaspoon) of formula milk (Treatment D) on Day 1.
16226877|NCT01186497|Drug|Rabeprazole sodium: Treatment A|The contents of 2 rabeprazole sprinkle capsules equivalent to 10 mg rabeprazole sodium mixed with a strawberry-flavored vehicle suspension (Treatment A) on Day 1.
16226878|NCT01186497|Drug|Rabeprazole sodium: Treatment B|The contents of 2 rabeprazole sodium sprinkle capsules equivalent to 10 mg rabeprazole sodium sprinkled on 1 tablespoon of plain yogurt (Treatment B) on Day 1.
16226879|NCT01186484|Drug|JNJ-212082|250 mg, 500 mg or 1000 mg once daily up to discontinuation for any reasons such as progression of the disease or up to the transition to extension study.
16226880|NCT01186471|Other|A643 (nicotine)|1mg oromucosal nicotine spray- three times daily during each treatment period
16226881|NCT01186471|Other|A643 (nicotine)|2mg oromucosal nicotine spray- three times daily during each treatment period
16226882|NCT01186471|Drug|placebo|placebo - three times daily during each treatment period
16226883|NCT01186458|Drug|Fludarabine|Fludarabine 25 mg/m2 IV over 30 minutes on days 1, 2, 4. Cycle = 28 days; maximum of 6 cycles of therapy.
16226884|NCT01186458|Drug|Velcade|Velcade (given after fludarabine)1.3 mg/m2 IV push over 3 to 5 seconds on days 1, 4, 8, 11. Cycle = 28 days; maximum of 6 cycles of therapy.
16226885|NCT01186458|Drug|Rituximab|Rituximab given after Velcade) 375 mg/m2 IV piggyback on day 1. Cycle = 28 days; maximum of 6 cycles of therapy.
16226886|NCT01186445|Drug|morphine chlorhydrate|1mg of morphine chlorhydrate dilute in 3ml of saline solution, intracoronary injection, just before reperfusion
16226893|NCT01186406|Drug|Temodar|At a minimum of four weeks, but not greater than eight weeks post-craniotomy, subjects will be treated with standard radiation therapy and daily Temodar (75mg/m2) for 6.5 weeks of the radiation. In addition, beginning 2-3 weeks after the last radiation therapy, but not greater than 8 weeks, patients will be treated with 5 day Temodar (200 mg/ m2).
16226894|NCT01186393|Behavioral|Control|Dietary manipulation in the free-living setting to include potatoes/potato products frequently in the diet (5-7 days / week). The control diet will be prescribed for weight maintenance.
16226895|NCT01186393|Behavioral|Low Glycemic Index|Diets will be energy-restricted (~ 500 kcal deficit /d) for weight loss, will include consumption of 5-7 potatoes/week, and will focus on Low Glycemic Index foods.
16226896|NCT01186393|Behavioral|High Glycemic Index|Diets will be energy-restricted (~ 500 kcal deficit /d) for weight loss, will include consumption of 5-7 potatoes/week, and will focus on Low Glycemic Index foods.
16226897|NCT01186380|Device|PET-512MC|Transesophageal Transducer
16226898|NCT01186367|Behavioral|Linear Aerobic Training|The 130-180 minutes/week will be achieved via either 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes per/session (± 10 minutes).
16226899|NCT01186367|Behavioral|Nonlinear Aerobic Training|The 130-180 minutes/week will be achieved via 3 to 4 individual aerobic training sessions at approximately 10 to 50 minutes/ per session (+/- 10 minutes).
16226900|NCT01186367|Behavioral|Progressive Stretching|All sessions are required to be supervised. Duration of the stretching sessions is prescribed and implemented in accordance with standard stretching and flexibility training principles. This approach will be applied to guide each participant's prescribed stretching plan, with dose and scheduling modifications made by exercise physiologists, as required.
16226901|NCT01186367|Other|Cardiopulmonary exercise test (CPET)|
16226902|NCT01186367|Other|Blood draws|Complete blood count
16226903|NCT01186354|Behavioral|Receiving results via genetic counselor|participants will receive genetic risk information for Type 2 diabetes from a board certified genetic counselor
16226904|NCT01186328|Drug|EZN-3042|Dose will be assigned at study entry. To be given as a 2 hour intravenous infusion on days -5, -2, 8, 15, 22 and 29. Dose levels: L0 (level zero): 1.5 mg/kg, L1: 2.5 mg/kg, L2: 5 mg/kg, L3: 6.5 mg/kg
16226905|NCT01186328|Drug|Cytarabine|"Given intrathecally on day -6. Patients who may have received intrathecal chemotherapy within 7 days of day 0 as part of their prior maintenance chemotherapy (e.g. before the diagnosis of relapse) or as part of the diagnostic workup will not receive this dose of IT cytarabine. If given, dose is defined by age:
~1-1.99 years: 30 mg 2-2.99 years: 50 mg
~Greater than or equal to 3 years: 70 mg.
~Cytarabine is also part of the triple intrathecal therapy given to CNS 3 patients on Days 8, 15, 22 and 29. Dose is defined by age:
~- 1.99 years: 16 mg
~- 2.99 years: 20 mg
~- 8.99 years: 24 mg
~Greater than or equal to 9 years: 30 mg"
16226906|NCT01186328|Drug|Doxorubicin|60 mg/m2/day given intravenous infusion (IV) over 15 minutes on day 1.
16226907|NCT01186328|Drug|Prednisone|40 mg/m2/day divided BID or TID given orally on days 1 through 29. For patients who are unable to tolerate prednisone orally, substitute IV methylprednisolone at 80% of the oral prednisone dose.
16226908|NCT01186328|Drug|Vincristine|1.5 mg/m2/day (maximum dose 2 mg) given intravenous push over 1 minute or infusion via mini-bag as per institutional policy on days 1, 8, 15 and 22.
16226909|NCT01186328|Drug|PEG-asparaginase|2500 IU/m2 intramuscular injection on days 2, 9, 16, 23. If available, Erwinia L-asparaginase may be substituted for pegaspargase in patients with clinically significant prior allergies to pegaspargase.
16226910|NCT01186328|Drug|Methotrexate|"Given intrathecally to patients with CNS1 or CNS2 disease at the dose defined by age below on days 15 and 36:
~1-1.99 years: 8 mg 2-2.99 years: 10 mg 3-8.99 years: 12 mg
~Greater than or equal to 9 years: 15 mg
~Given as part of the Triple intrathecal therapy to patients with CNS 3 disease at the doses defined by age below on days 8, 15, 22 and 29:
~- 1.99 years: 8 mg
~- 2.99 years: 10 mg
~- 8.99 years: 12 mg
~Greater than or equal to 9 years: 15 mg"
16226911|NCT01186328|Drug|Hydrocortisone|"Given as part of the Triple intrathecal therapy to patients with CNS 3 disease at the doses defined by age below on days 8, 15, 22 and 29:
~- 1.99 years: 8 mg
~- 2.99 years: 10 mg
~- 8.99 years: 12 mg
~Greater than or equal to 9 years: 15 mg"
16226912|NCT01186315|Behavioral|Prolonged Exposure Therapy|These treatments include repeated exposure to intrusive trauma-related memories in a safe and structured manner designed to reduce emotional arousal and facilitate processing of trauma-related memories.
16226913|NCT01186315|Behavioral|Prolonged Exposure therapy + VR/ER|The therapy includes repeated exposure to intrusive trauma-related memories in a safe and structured manner designed to reduce emotional arousal and facilitate processing of trauma-related memories and adding in virtual reality (VR)-based exposure to cues for marijuana, cocaine, heroin, cigarette, and/or alcohol use & CER used outside treatment sessions in response to VR exposure (available 24 hours per day/7 days per week) to high-risk contexts for drug use
16226914|NCT01186302|Other|Type of provider|Different types of clinicians have different types of medical training. This study tested whether midlevel providers were as safe and effective in administering medical abortion as doctors. All types of providers underwent the same training in medical abortion and used the same medical abortion regimen.
16226915|NCT01186289|Drug|atorvastatin|high dose atorvastatin therapy (80 mg/day) beginning 48 to 72-hours preoperatively and continuing until 6-weeks postoperatively
16226916|NCT01186276|Dietary Supplement|Fiber|Dietary fiber supplements to be consumed daily for 6 weeks.
16226917|NCT01186276|Dietary Supplement|Corn starch|Corn starch to be consumed daily for 6 weeks. This will serve as the control/placebo arm.
16226918|NCT01186263|Drug|MAA for diagnostic SPECT imaging|Intraarterial application of 5ml containing 500.000 particles with an activity of 150MBq.
16226919|NCT01186263|Drug|Diagnostic B20- SPECT imaging.|Intraarterial application of 5ml containing 150.000 particles with an activity of 150 MBq.
16226920|NCT01186250|Drug|Pioglitazone|15mg pioglitazone taken daily for one month, 30mg pioglitazone taken daily for another month, 45mg pioglitazone taken daily for remaining ten months
16226921|NCT01186250|Drug|Placebo|placebo taken daily for one year
16226922|NCT01186237|Procedure|Early urinary catheter removal|All patients will have foley catheters removed between 0600 and midnight of post-operative day 3 (Day 0 being the day of operation).
16226958|NCT01185925|Drug|Sildenafil|Sildenafil, 50 mg 3 times/day
16226959|NCT01185925|Drug|Placebo|Placebo
16226960|NCT01185912|Procedure|Ventricle muscle tissue samples|
16226923|NCT01186224|Drug|Plerixafor and G-CSF|"G-CSF will be given daily from day 1, which will usually be timed to fall toward the end of the working week. Plerixafor will commence on day 4 at as near to 10 PM as practicable, and also on day 5 and subsequent days (maximum of 4 total days) at a similar time of day if insufficient CD34+ cells have been collected. Stem cell harvesting will be carried out on day 5 and if necessary on days 6, 7 and 8, until the target yield of 4 x 106 CD34+ cells /kg recipient weight have been achieved.
~The daily dose of G-CSF is 300 ug for patients up to and including 60kg in weight; 480 ug for patients over 60 kg but under 96 kg, and 600 ug for patients weighing 96 kg or more. This equates to a dose of at least 5 ug/kg (maximum 8 mg/kg) for all patients up to 120 kg. The daily dose of plerixafor is 240 ug/kg if the creatinine clearance is equal to or greater than 50mls/minute; if less than this then the dose is 160 ug/kg daily."
16226924|NCT01186198|Device|MINI TREK RX 1.20 mm Coronary Dilatation Catheter|Enlarging coronary luminal diameter during percutaneous coronary intervention (PCI) procedures in subjects with ischemic heart disease due to stenotic lesions
16226925|NCT01186185|Drug|Fludrocortisone|Fludrocortisone 0.2 mg by mouth daily for 30 days
16226926|NCT01186172|Drug|Ethanol-lock therapy|Daily ethanol-lock with 70% ethanol instilled in device dead-space, leaved in place for the longest possible interval, and then discarded. For dialysis devices, it is acceptable to leave the lock in place between dialysis sessions. Lock therapy will be continued for 7 days.
16226927|NCT01186172|Drug|Antibiotic-lock|Daily antibiotic-lock according to 2009 IDSA Guidelines,instilled in device dead-space, leaved in place for the longest possible interval, and then discarded. For dialysis devices, it is acceptable to leave the lock in place between dialysis sessions. Lock therapy will be continued for 7 days.
16226928|NCT01186159|Drug|Parecoxib Sodium|40 mg Parecoxib Sodium is give to the patients intravenously (diluted with 5 ml normal saline) at 30 minutes before surgery, 20 mg Parecoxib Sodium (diluted with 5 ml normal saline) at 8 hours,20 hours,32 hours,44 hours,56 hours after surgery respectively.
16226929|NCT01186146|Drug|Aspirin monotherapy|stopping clopidogrel at 1 year after DES
16226930|NCT01186146|Drug|Aspirin,Clopidogrel|continue aspirin and clopidogrel 1year after DES
16226931|NCT01186120|Device|Biolimus A9-eluting stent|drug-eluting stent
16226932|NCT01186120|Device|Everolimus-eluting stent|drug-eluting stent
16226933|NCT01186107|Device|Endeavor Resolute stent|zotarolimus-eluting stent
16226934|NCT01186107|Device|Cypher stent|sirolimus-eluting stent
16226935|NCT01186094|Device|Cypher|Sirolimus-eluting stent
16226936|NCT01186094|Device|Endeavor Resolute|Zotarolimus-eluting Stent
16226937|NCT01186081|Radiation|Preoperative chemoradiotherapy|Preoperative chemoradiation with conventional radiotherapy (46 Gy in 23 fractions to the whole pelvis followed by a boost dose of 4 Gy in 2 fractions) and oral fluoropyrimidine (capecitabine 825 mg/m2 twice per day without weekend breaks during whole radiotherapy period)
16226938|NCT01186081|Radiation|Postoperative chemoradiotherapy|Postoperative radiotherapy with conventional radiation schedule (50 Gy in 25 fractions to the whole pelvis) and oral fluoropyrimidine (capecitabine 825 mg/m2 twice per day without weekend breaks during whole radiotherapy period)
16226939|NCT01186068|Drug|V-101|Cream QD
16226940|NCT01186068|Other|vehicle|Cream QD
16226941|NCT01186055|Behavioral|Smoking Cessation Counseling|Participants shall all receive 8 weeks (6 weeks) of group or individual counseling during their quit attempt.
16226942|NCT01186042|Other|Observational|No intervention
16226943|NCT01186029|Drug|aprepitant|Emend 40mg by mouth 30 minutes before procedure x 1
16226944|NCT01186016|Behavioral|Genetic Education Session|The intervention includes receiving education about genetics and smoking. The content is basic genetics and education about the multifactorial nature of smoking; research findings about genetic contributions to smoking, potential applications of this research for cessation treatment, and legal, ethical and social implications of future use of genotyping for cessation. All participants also receive a 5-week standard cognitive-behavioral smoking cessation intervention with 6 weeks of OTC transdermal nicotine replacement therapy.
16226945|NCT01186016|Behavioral|Nutrition Education Session|To control for an attention placebo effect, the control group will receive information about nutritional guidelines as established by the USDA and the FDA. The attention control group will be referred to as the Nutritional Education Session (NES) group. The content of NES sessions one and two are use of the USDA (MyPyramid) dietary and food safety guidelines. All participants also receive a 5-week standard cognitive-behavioral smoking cessation intervention with 6 weeks of OTC transdermal nicotine replacement therapy.
16226946|NCT01186003|Drug|Detemir|Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy
16226947|NCT01185977|Drug|Fluoxetine|one-week single-blind PBO-lead-in phase, FLX 10 mg/d for 4 days then 20 mg/d of FLX thereafter
16226948|NCT01185977|Drug|Placebo|One pill of PBO for 4 days then two pills of PBO thereafter
16226949|NCT01185964|Biological|Olaratumab|Olaratumab 15 mg/kg by intravenous transfusion (I.V.) on days 1+8 of a 21-day cycle
16226950|NCT01185964|Drug|doxorubicin|Doxorubicin 75 mg/m2 by intravenous injection on day 1 of the 21-day cycle.
16226951|NCT01185951|Drug|Polidocanol|Power-Doppler-guided extratendinous sclerosing therapy using Polidocanol 0.5% up to 2ml every 6-8 weeks
16226952|NCT01185951|Device|Focused extracorporeal shock wave therapy|Focused extracorporeal shock wave therapy using a STORZ Duolith machine 2000 Impulses 0.25mJ/mm2 every 6-8 weeks
16226953|NCT01185951|Drug|Topical NO|Topical nitroglycerine (Nitrolingualspray(R)) 2x2 hubs per day over 6 months daily on the painful tendon
16226954|NCT01185951|Behavioral|Painful eccentric training in Achilles tendinopathy|Painful eccentric training for Achilles tendinopathy on a stair single-stance with 6x15 repetitions per leg and day over at least 12 weeks
16226955|NCT01185951|Behavioral|Painful eccentric training for patella tendinopathy on 25° decline board|Painful eccentric training for patella tendinopathy on a 25° decline board single-stance with 6x15 repetitions per leg and day over at least 12 weeks
16226956|NCT01185951|Behavioral|Painful eccentric training for elbow tendinopathy using Thera-Band Flex-Bar|Painful eccentric training for elbow tendinopathy using a green coloured Thera-Band Flex-Bar with painful supination and pronation with 6x15 repetitions per day over at least 12 weeks
16226957|NCT01185938|Drug|Rosuvastatin|One oral single dose of rosuvastatin of 40 mg at admission and then 20 mg/day for 1 month.
16226972|NCT01185860|Drug|ribavirin|1000-1200mg/day po
16226973|NCT01185860|Drug|ritonavir|oral doses
16226974|NCT01185847|Drug|RO5083945|intravenously, until disease progression
16226975|NCT01185847|Drug|cisplatin|standard treatment, up to 6 cycles
16226976|NCT01185847|Drug|gemcitabine|standard treatment, up to 6 cycles
16226977|NCT01185847|Drug|pemetrexed|standard treatment, up to 6 cycles
16226978|NCT01185834|Device|Lotrafilcon A upgrade soft contact lens|Silicone hydrogel contact lens approved for daily wear and extended wear up to 30 consecutive nights.
16226979|NCT01185821|Drug|BAF312|BAF312 was supplied in film-coated tablets in strengths of 5, 4 ,2, 1, .5 and .25 mg. The actual doses taken were 10, 2, 1.25, .5 and .25 mg taken orally once a day.
16226980|NCT01185808|Biological|Vitamin D|Vitamin D 5000IU/day for 6 weeks
16226981|NCT01185795|Dietary Supplement|Cardioviva™ yogurt|L. reuteri cardioviva in yogurt, twice per day (BID), 6 weeks
16226982|NCT01185795|Dietary Supplement|Placebo yogurt|yogurt, twice per day (BID), 6 weeks
16226983|NCT01185782|Drug|Gonalef® (Follitropin alfa)|Subcutaneous administration of follitropin alfa at a dose of 75 IU/day was started on dosing Day 1 and the same daily dose was maintained for the first 7 days of the treatment period. Dose increment by 37.5 IU was permitted on dosing Day 8, Day 15 and Day 22 if the dosage increase criterion was met.
16226984|NCT01185782|Drug|Purified pituitary gonadotropin (Fertinorm-P®)|Subcutaneous administration of purified pituitary gonadotropin at a dose of 75 IU/day was started on dosing Day 1 and the same daily dose was maintained for the first 7 days of the treatment period. Dose increment by 37.5 IU was permitted on dosing Day 8, Day 15 and Day 22 if the dosage increase criterion was met.
16226985|NCT01185769|Dietary Supplement|Tocotrienol|500 mg of tocotrienol will be administered after consumption of high fat diet
16226986|NCT01185769|Dietary Supplement|Tocotrienol|500 mg of tocotrienol will be administered after consumption of low fat diet
16226987|NCT01185756|Radiation|MIBG for diagnostic purpose|All patients will undergo the diagnostic test specific to the study.
16226988|NCT01185743|Drug|olanzapine|olanzapine 10mg od + placebo od
16226989|NCT01185743|Drug|ziprasidone|ziprasidone 40mg td
16226990|NCT01185743|Drug|placebo|placebo td
16226991|NCT01185730|Procedure|Right Heart Catheterization|all patients of the all centers will have Right Heart Catheterization at the diagnosis
16226992|NCT01185704|Drug|Cetrorelix acetate|Cetrotide® 0.25 mg will be administered subcutaneously once daily from Day 1 (Day 0 of stimulation period [S0]) until r-hCG day (at least 2 follicles >=17 mm)
16226993|NCT01185704|Drug|Cetrorelix acetate|Cetrotide® 0.25 mg will be administered subcutaneously once daily from Day 7 (Day 6 of stimulation period [S6]) until r-hCG day (at least 2 follicles >=19 mm)
16226994|NCT01185704|Drug|Recombinant Human Choriogonadotropin (r-hCG)|The r-hCG will be administered subcutaneously as a single dose of 250 microgram (mcg) on r-hCG day
16226995|NCT01185704|Drug|Recombinant human follicle stimulating hormone (r-hFSH)|Recombinant human follicle stimulating hormone (r-hFSH) will be administered subcutaneously at a dose between 75 and 187.5 international unit (IU) once daily from Day 2 (Day 1 of stimulation period [S1]) until r-hCG day
16226996|NCT01185691|Device|Impella 2.5|Impella 2.5 implant in patients with acute decompensated heart failure
16226997|NCT01185678|Drug|Qlaira or Yaz (BSP products defined as Combined Oral Contraceptive) and Cerazette or Azalia (competitor's products defined as Progestogen Only Pill)|One tablet per day, orally, 28 tablets per cycle, during three consecutive cycles.
16226998|NCT01185665|Device|TENS|Transcutaneous Electrical Nerve Stimulator
16226999|NCT01185665|Device|Sham-TENS|TENS without electrical output, from the outside not different from a normal TENS
16227000|NCT01185639|Radiation|stereotactic body radiation therapy|For lung, liver, axial skeleton, and adrenal tumors a dose of either 54 Gy in 3 fxs or 5000 cGy in 5 fx using SBRT techniques
16227001|NCT01185626|Other|SCP care|
16227002|NCT01185613|Device|Therapy™ Cool Flex Ablation Catheter|"The device under evaluation is the 4mm Therapy™ Cool Flex Ablation Catheter. The Therapy™ Cool Flex catheter is a flexible tip, insulated, 7F catheter constructed of thermoplastic elastomer material and noble metal electrodes.
~The following CE Mark devices will be used in conjunction with the Therapy™ Cool Flex Ablation Catheter
~IBI-1500T11 Cardiac Ablation Generator (RF ablation generator) with software version 3.0 or higher.
~Cool Point™ Irrigation Pump
~Cool Point™ Tubing set
~Data Logger"
16227003|NCT01185600|Biological|Washed RBC|There is no pre-set dosage, frequency and duration for transfusion with washed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed washed RBC for the subject.
16227004|NCT01185600|Biological|Unwashed RBC|There is no pre-set dosage, frequency and duration for transfusion with unwashed RBC. It all depends on the conditions of patients during and after surgery. As circumstances arise, the physician will request needed unwashed RBC for the subject.
16227005|NCT01185574|Dietary Supplement|Vitamin D supplementation|Vitamin D2 50,000 IU will be administered once a week for six months.
16227006|NCT01185561|Behavioral|Psychoeducational intervention|The intervention is group therapy for depression treatment based on cognitive behavioral therapy principles developed for women with type 2 diabetes. Specifically, the intervention comprises activities including (1) Education about how dysphoric symptoms (i.e., depressive symptoms, anxiety, and anger) affect glycemic control; (2) Recognition of dysphoric symptoms; and (3) Management of dysphoric symptoms using cognitive-behavioral skills.
16227007|NCT01185548|Drug|Tolbutamide|Administered orally
16227008|NCT01185548|Drug|Tasisulam|Administered intravenously
16227009|NCT01185535|Procedure|times of topical anesthesia for glottis|topical anesthesia with pressure nebulized 2% lidocaine for glottis either two times or three times or four times
16227010|NCT01185509|Drug|trastuzumab|
16227011|NCT01185509|Drug|vinorelbine|
16227012|NCT01185470|Device|Implantation of Morphine Sulfate delivering programmable pump|Patients with chronic pain responsive to intrathecal opioid analgesia as demonstrated in a morphine trial or patients with a previous successful intrathecal opioid therapy with an implantable pump will undergo implantation of pump for intrathecal delivery of Morphine Sulfate.
16227057|NCT01185132|Radiation|accelerated partial breast irradiation - 3D-conformal planning|38.5 Gy, 10 fractions over 5 days
16227058|NCT01185132|Radiation|accelerated partial breast irradiation - IMRT planning|38.5 Gy, 10 fractions over 5 days
16227013|NCT01185444|Procedure|Hya-Joint|The Hya-Joint group received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hya-Joint, derived from Streptococcus zooepidemicus and produced by a highly purified biologic fermentation process, molecular weight 650-1200 kDa),into the target knee.
16227014|NCT01185444|Procedure|Hyalgan|The control group received 3 weekly intraarticular injections of 2 ml sodium hyaluronate (Hyalgan, extracted from chicken combs, molecular weight 500-730kDa) into the knee joints.
16227015|NCT01185431|Dietary Supplement|Ficus carica (Fig paste)|Ficus carica paste 300g/day
16227016|NCT01185431|Dietary Supplement|Placebo (Placebo paste)|Placebo composition 300g/day
16227017|NCT01185418|Drug|risperidone|
16227018|NCT01185418|Drug|aripiprazole|
16227019|NCT01185418|Drug|haloperidol|
16227020|NCT01185418|Drug|amisulpride|
16227021|NCT01185418|Drug|lactose|
16227022|NCT01185405|Other|Use of different strategy for voriconazole dosage adjustment|Patients will be randomly assigned into 2 groups: conventional adjustment group (CA group) and early adjustment group (EA group). Voriconazole plasma levels will be measured on day 1 (both peak and trough levels), day 3, day 5, day 10, and day 14 (all trough levels). For CA group patients, voriconazole dosage will be adjusted according to the trough levels of day 5 (steady-state level). Predefined dose adjustment protocol will be used (< 1 µg/ml: 50% increase, 1~5.5 µg/ml: no change, > 5.5 µg/ml: 50% decrease). For EA group patients, voriconazole dosage will be adjusted according to the each measurements of voriconazole levels from day 1. Adjusted dosage will be calculated using the NONMEN software.
16227023|NCT01185379|Dietary Supplement|Efalex active 50+|4 x 500 mg Efalax Active 50+, to be taken daily for 6 months.
16227024|NCT01185379|Dietary Supplement|DHA rich fish oil|4 x 500 mg DHA rich tuna oil to be taken daily for 6 months
16227025|NCT01185379|Dietary Supplement|Placebo|4 x 500 mg capsules to be taken daily for 6 months
16227026|NCT01185366|Drug|Everolimus|10 mg by mouth once a day.
16227027|NCT01185366|Drug|Sunitinib|50 mg by mouth daily for 4 weeks on / 2 weeks off
16227028|NCT01185353|Drug|LY3009104|Administered orally
16227029|NCT01185353|Drug|Placebo|Administered orally
16227030|NCT01185353|Drug|Methotrexate|Administered orally as background therapy
16227031|NCT01185340|Drug|LY2216684|
16227032|NCT01185340|Drug|Placebo|
16227033|NCT01185340|Drug|SSRI|Participants should have been on their SSRI for at least 6 weeks prior and were to continue on their stable dose throughout the study
16227034|NCT01185327|Behavioral|Breastfeeding|Breastfeeding
16227035|NCT01185314|Procedure|Testing for mutation status|EGFR mutation test
16227036|NCT01185301|Biological|adalimumab|Pre-filled syringe every other week
16227037|NCT01185301|Drug|methotrexate|weekly oral capsule dosing
16227038|NCT01185288|Biological|Adalimumab|Adalimumab in pre-filled syringes
16227039|NCT01185288|Drug|Methotrexate|Methotrexate capsule
16227040|NCT01185275|Device|Alair system|Bronchial thermoplasty
16227041|NCT01185262|Drug|Lenalidomida and Rituximab|"Lenalidomide: Oral use. It will be administered from day 1 to 21 of 28 days cycles in a total of 6 cycles.
~Rituximab, intravenous use. The dose will be administered at the standard (375 mg/m2 in the first cycle and 500 mg/m2 in successive cycles).
~In the first cycle Rituximab will be administered in two divided doses:100mg/m2 total on day 1 and the rest up to 375mg/m2 on day 2.
~If lenalidomide treatment starts on day 1, Rituximab will be administered, in this first cycle, on days -2 (100 mg/m2) and -1 (275 mg/m2).
~In the second and subsequent cycles, 500 mg/m2 of Rituximab will be administered on day -1."
16227042|NCT01185249|Procedure|Weigh subjects on a scale in the standing position|Subjects will stand on a scale in the mornings, and the evenings for 3 days while hospitalized.
16227043|NCT01185236|Drug|simvastatin/ezetimibe|simvastatin/ezetimibe 10/20mg once daily for 12weeks
16227044|NCT01185236|Drug|atorvastatin 20mg|atorvastatin 20mg once daily for 12weeks
16227045|NCT01185223|Drug|Valganciclovir|Valganciclovir 450mg tablet or Valganciclovir powder for oral solution 50mg/mL
16227046|NCT01185223|Drug|Ganciclovir|2x5mg/kg/d intravenous ganciclovir
16227047|NCT01185210|Dietary Supplement|Placebo|Subjects will receive placebo (mix of sugar and salt) 20 minutes before consuming fructose.
16227048|NCT01185210|Dietary Supplement|Alanine|Subjects will receive 12.5 grams of alanine 20 minutes before consuming fructose.
16227049|NCT01185210|Dietary Supplement|Alanine|Subjects will receive 25 grams of alanine 20 minutes before consuming fructose.
16227050|NCT01185197|Drug|Myfortic plus low-dose steroid|Prednisolone: 0.25 mg/kg/day for 8 weeks then 0.15 mg/kg/day for 8 weeks then 0.1 mg/kg/day for 8 weeks then off Myfortic: 720 mg b.i.d. (540 mg b.i.d. if body weight less than 60 kg) for 24 weeks then off
16227051|NCT01185197|Drug|Prednisolone|1 mg/kg/day to be tapered over a period of 24 weeks at the discretion of the attending physician
16227052|NCT01185184|Drug|CP-690,550|Single doses separated by a minimum of 72 hour washout between treatments
16227053|NCT01185171|Drug|ZD 1839 500mg|"Optional Induction chemotherapy:
~Carboplatin and paclitaxel combination will be administered for 2 cycles of 4 weeks duration each. Paclitaxel: 100 mg/m2 in 500 ml of dextrose 5% in water over 3hrs. Carboplatin: Start after completion of paclitaxel on Day 1 AUC 6 (creatinine clearance [CC] + 25). Administered in 100 ml of normal saline over 30min after completion of paclitaxel.
~Resume chemotherapy C2 on D29. ZD1839: 500mg PO QD from D1 of C1 of chemoradiotherapy, uninterrupted until disease progression. Chemotherapy should be administered during all 5 weeks of radiotherapy. P.M.:Start hydroxyurea at 500 mg PO q 12hrs × 6 days. The first daily dose of hydroxyurea on Days 1 through 5 is given 2 hours prior to the first fraction of daily radiotherapy. P.M.:Start continuous infusion of 5-FU at 600 mg/m2/day × 5D. Days 1 through 5: Radiation therapy is administered twice daily at 150 cGy ZD1839 will be administered from day 1 to 14 of every chemoradiotherapy cycle."
16227054|NCT01185158|Drug|ZD1839 (IRESSA)|ZD1839: 250mg/day po or via g-tube Q 24 hours
16227055|NCT01185145|Radiation|Breast Brachytherapy with Mammosite RTS|Treatment will be performed using high dose rate brachytherapy, starting between 2-5 days of implant, 34 Gy at 1 cm in 3.4 Gy fractions BID for 5 treatment days with typical boost dose od 10 Gy given in 2 fractions at least 6 hours apart.
16227056|NCT01185145|Radiation|Intensity Modulated Radiotherapy|Accelerated Partial Breast Irradiation using intensity modulated radiotherapy, a novel planning and delivery technique for external beam radiation
16227059|NCT01185119|Drug|native glp-1 (7-36)|During hyperglycemic clamp and GLP-1 versus placebo infusion 10 men will be CNS-PET scanned
16227060|NCT01185080|Drug|AZD8848|Nasal spray solution, intranasal, three times weekly for one month
16227061|NCT01185080|Drug|Placebo|Nasal spray solution, intranasal, three times weekly for one month
16227062|NCT01185080|Drug|AZD8848 and placebo|Nasal spray solution, intranasal, three times weekly for one month
16227063|NCT01185067|Drug|grape seed extract (MegaNatural BP, Polyphenolics, Inc.)|Subjects will be randomized in double-blind fashion to either grape seed extract (GSE) or maltodextrin placebo capsules for for 6 weeks. Patient will take 300 mg GSE/placebo twice a day for 6 weeks. Patient will have a 2 week washout period and then cross over to the opposite group for an additional 6 weeks.
16227064|NCT01185054|Other|½ strength apple juice|For each episode of diarrhea 10 ml/kg of fluid will be given and for each episode of vomiting 2 ml/kg will be given. If the child does not like the solution another fluid can be used.
16227065|NCT01185054|Other|Pediatric Electrolyte|For each episode of diarrhea 10 ml/kg of fluid will be given and for each episode of vomiting 2 ml/kg will be given. If the child does not like the solution another electrolyte maintenance fluid can be used. Fluids containing non-physiological concentrations of glucose and electrolytes (carbonated drinks, sweetened fruit juices, water) will be discouraged.
16227066|NCT01185041|Dietary Supplement|Watermelon Extract|6 weeks of watermelon extract taken in two doses of 3g each per day (6g per day)containing L-citrulline/L-arginine (4/2 g)
16227067|NCT01185028|Drug|Nitazoxanide With Pegylated Interferon And Ribavirin|Nitazoxanide 500mg po bid for 4 wks followed by peg-IFN/Ribavirin/nitazoxanide for 48 weeks
16227068|NCT01185015|Drug|Sigmart (nicorandil)|Sigmart will be administered for 2 weeks when the subject enters the secondary treatment period (Day 15 to approximately Day 28), at the dosage of 5 mg per oral tid in addition to the previous anti-anginal regimen.
16227069|NCT01185002|Other|PillCam® COLON 2 procedure using MgC boosts|Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. During the CE procedure the subjects will be required to take MgC boosts.
16227070|NCT01185002|Other|PillCam® COLON 2 procedure using Suprep boosts|Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. During the CE procedure the subjects will be required to take Suprep boosts
16227071|NCT01185002|Other|PillCam® COLON 2 procedure using reduced dose of Suprep boosts|Subjects will be instructed to perform the colon preparation procedure and follow a detailed dietary regimen prior to and during the CE procedure. During the CE procedure the subjects will be required to take reduced dose of Suprep boosts
16227072|NCT01184989|Drug|Dabigatran etexilate|once daily approved dose by EMEA and Health Canada
16227073|NCT01184976|Biological|VGX-3400|Plasmid DNA delivered via IM injection with electroporation
16227074|NCT01184963|Dietary Supplement|High protein diet|High protein diet (30% protein, 40% carbohydrate, 30% lipid)
16227075|NCT01184963|Dietary Supplement|Normal protein diet|Normal protein diet (15% protein, 55% carbohydrate, 30% lipid
16227076|NCT01184950|Other|Trainer Curriculum|
16227077|NCT01184937|Behavioral|Patient education program|"All patients receive standard care. Experimental group receive a structured patient education program based in self-care theory and pedagogical theory, build upon the the principles of the Pro-Self education program. The intervention program consist of five weekly one-to-one sessions with a transplant nurse, lasting about 40-60 minutes, starting during the first week after discharge and lasting until 7 weeks post transplantation. Education content consists of two levels: general knowledge level and individual knowledge. Each session has a specific program. In addition, academic detailing is used to describe patient's knowledge levels and for tailoring the education to individual needs."
16227078|NCT01184924|Behavioral|Evaluation of the Arthritis Foundation Tai Chi Program|The primary goal of this study is to assess the effectiveness and feasibility of the arthritis foundation (AF) Tai Chi Program for People with Arthritis. Arthritis, the most prevalent chronic condition in the US and a leading cause of disability, is characterized by chronic pain and progressive impairment of joints and soft tissues. Promoting physical activity is a key public health strategy to addressing arthritis management, but more scientific data regarding effectiveness and feasibility are need to support the promotion of the AF Tai Chi Program as an exercise intervention for people with arthritis. Participants will be randomly assigned to the intervention or delayed control arm of the study.
16227079|NCT01184911|Drug|Sulfadoxine-pyrimethamine|Sulfadoxine-pyrimethamine tablets, once
16227080|NCT01184898|Drug|Sirolimus|Sirolimus, by mouth, will be given as a 12mg loading dose followed by 8 daily doses of 4mg/day.
16227081|NCT01184898|Drug|Mitoxantrone|Mitoxantrone 8mg/m2/day IV
16227082|NCT01184898|Drug|Etoposide|100 mg/m2/day IV
16227083|NCT01184898|Drug|Cytarabine|1000mg/m2/day IV every 24 hours for 5 days
16227084|NCT01184885|Drug|Hyper-CVAD|"Cycle A: Cyclophosphamide 300mg/m2 every 12 hours on days 3-5; Vincristine 2mg/day on days 6 and 13; Doxorubicin 50mg/m2 on day 6; Decadron 40mg/ day po on days 3-6 and 13-16; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.
~Cycle B: Methotrexate 1000mg/m2 on day 3; Leucovorin 50mg every 6 hours starting 24 hours from the beginning of the MTX infusion until MTX levels are < 0.1 umol/L; Ara-C 3000mg/m2 every 12 hours on days 4 and 5; Methotrexate 12mg IT on day 4; Ara-C 100mg IT on day 9.
~Rituximab (if given) will be 375 mg/m2 on Days 3 and 13 of Cycle A and on Days 4 and 9 of cycle B, for a total of 8 doses over the first 4 courses."
16227085|NCT01184885|Drug|Sirolimus|Sirolimus loading dose of 12mg on day 1 followed by a single daily dose of 4 mg/ day on days 2 through 7 (Cycle A) and on days 2 through 6 (Cycle B)
16227086|NCT01184872|Drug|Daptomycin|"Patients with bacteremia: Daptomycin 6 mg/Kg intravenous once daily for at least 5 days and up to 28 days.
~Patients without bacteremia: Daptomycin 4 mg/Kg intravenous once daily for at least 5 days and up to 14 days."
16227087|NCT01184872|Drug|Vancomycin or Semi-Synthetic Penicillins (SSPs)|"Patients with bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 4 hours for at least 5 days and up to 28 days.
~Patients without bacteremia: Vancomycin 1 g intravenous twice daily or Semi-Synthetic Penicillins 2 g intravenous every 6 hours for at least 5 days and up to 14 days."
16227088|NCT01184859|Drug|Desmopressin|Desmopressin oral lyophilisate melt tablet, in either the 10, 25, 50, or 100 μg dosage, for sublingual administration
16227089|NCT01184859|Drug|Placebo|Placebo melt tablet for sublingual administration
16227090|NCT01184846|Biological|10% liquid formulation of human immunoglobulin|
16227091|NCT01184833|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|Patients treated with regular dose of Betaferon injections (250 micrograms subcutaneously every other day) under the routine practice setting.
16227092|NCT01184820|Biological|BAY94-9027 + Recombinant Factor VIII (Kogenate FS, BAY14-2222)|Single dose of Kogenate FS and 16 doses of BAY94-9027 given 2 times a week for 8 weeks. Both drugs to be given intravenously.
16227093|NCT01184820|Biological|BAY94-9027 + Recombinant Factor VIII (Kogenate FS, BAY14-2222))|Single dose of Kogenate FS and 9 doses of BAY94-9027 given once a week for 8 weeks. Both drugs to be given intravenously.
16227094|NCT01184807|Drug|OPB-51602|OPB-51602 at a dose of 2, 5, 10, 20, 40, 60, 80, or 100 mg/day,will be orally administered to subjects once daily for 2 weeks in each cycle of treatment in Dose Escalation Stage.A 2-day treatment-free interval will occur on Days 2 and 3 for PK sampling. Study drug administration will resume on Day 4 and continue until Day 17 in cycle 1.In Expansion stage part 1, OPB-51602 will be administered at recommend dose (4mg) for 3 weeks per cycle 9 2 weeks treatment and 1 week washout). There is also 2-day treatment free interval between Day 1 and Day 4 for PK sampling in cycle 1.In Expansion stage part 2, subject dosing will be started on Day 1 without 2-day treatment free interval and continued until Day 28 at recommend dose (4mg) first in Cycle 1. The same subjects will be treated at MTD(5mg)from cycle 2 onwards for 4 weeks per cycle.
16227095|NCT01184794|Drug|levobupivacaine|40 ml over 48 hours
16227096|NCT01184781|Device|Comparison of capsule endoscopy Pillcam II™ versus colonoscopy|On the same patient, we compare both methods (video-colonoscopy vs capsule endoscopy)
16227097|NCT01184755|Behavioral|Relaxation|Participants are instructed to use the modified device (which paces the breath at a constant 13 breaths/minute) daily for 15 minutes (timing set automatically by device).
16227098|NCT01184755|Device|RESPeRate|
16227099|NCT01184716|Other|Vitamin D fortification|Bread and milk fortified with vitamin D3
16227100|NCT01184703|Other|Low GI food|Comparison of carbohydrates in diabetic patients
16227101|NCT01184690|Procedure|Single-operator double-balloon endoscopy|Single-operator double-balloon endoscopy
16227102|NCT01184690|Procedure|dual-operator double-balloon endoscopy|dual-operator double-balloon endoscopy
16227103|NCT01184677|Device|insertion of the ProSeal LMA (PLMA)|ProSeal LMA size 3 is inserted to the patients of Group size 3.
16227104|NCT01184677|Device|insertion of the PLMA|ProSeal LMA size 4 is inserted to the patients of Group size 4.
16227105|NCT01184664|Drug|Nicotine Patch|Varenicline + nicotine patch
16227106|NCT01184664|Drug|Placebo|Varenicline + placebo patch
16227107|NCT01184664|Drug|Varenicline|All participants will receive a standard dose of varenicline (12 weeks).
16227108|NCT01184651|Behavioral|Questionnaires/Interviews|Girls answer questions about activities and interests, school, feelings about being a girl, stage of physical development, and family relationships during a home interview , provide saliva samples, and participate in phone interviews to answer questions about daily activities .
16227109|NCT01184651|Behavioral|Questionnaires/Interviews|Parents complete questionnaires about their daughter's activities, interests, and behaviors, educational goals, family demographics and relationships, grades, diagnosis and treatment of her CAH, their own activities, interests, and thoughts and feelings about being male or female. Parents answer questions during phone interviews about their daughters daily activities.
16227110|NCT01184638|Drug|Sevoflurane|1-8% sevoflurane for maintaining the whole period of general anesthesia
16227111|NCT01184638|Drug|Propofol|1-4 mg/kg/h of propofol during the whole period of general anesthesia
16227112|NCT01184625|Other|Physical Exercise|12 weeks of physical exercise.
16227113|NCT01184612|Behavioral|Motivational Interviewing; MI|"MI is a communication style defined as a collaborative, person-centred form of guiding to elicit and strengthen motivation to change. The method is based on four principles: showing empathy; developing discrepancy between the subject's current behaviour and an alternate, more desired, behaviour; reinforcing self-efficacy; and rolling with resistance to change. Client arguments for change are elicited and reinforced in an atmosphere that is empathic, collaborative and supportive of autonomy. The choice to change and the responsibility for change remain with the client."
16227114|NCT01184599|Drug|aliskiren|150 mg/day p.o.
16227115|NCT01184586|Device|Intervention - ESWT Storz Duolith high energy|Three weekly sessions of extracorporeal shockwave therapy with focussed shock waves (2000 impulses, 0,35-1,25mJ/mm2)
16227116|NCT01184586|Device|CONTROL SHAM-ESWT Storz Duolith [0.01mJ/mm2]|Three weekly sessions of sham extracorporeal shock wave (2000 impulses, 0,01mJ/mm2)
16227117|NCT01184560|Drug|Sibutramine|"○ Dosing standard Run-in period: All subjects would administer Sibutramine placebo 1 capsule (once daily) and Orlistat placebo 1 capsule (three times daily). The total dosing period is 2 weeks.
~Treatment period: The total dosing period is 12 weeks.
~Sibutramine monotherapy group: Sibutramine 1 capsule once daily + Orlistat placebo 1 capsule three times daily
~Orlistat and Sibutramine combination group: Sibutramine 1 capsule once daily + Orlistat 1 capsule three times daily"
16227118|NCT01184560|Drug|Orlistat|"○ Dosing standard Run-in period: All subjects would administer Sibutramine placebo 1 capsule (once daily) and Orlistat placebo 1 capsule (three times daily). The total dosing period is 2 weeks.
~Treatment period: The total dosing period is 12 weeks.
~Sibutramine monotherapy group: Sibutramine 1 capsule once daily + Orlistat placebo 1 capsule three times daily
~Orlistat and Sibutramine combination group: Sibutramine 1 capsule once daily + Orlistat 1 capsule three times daily"
16227119|NCT01184547|Behavioral|Combex|12 weeks of exercise with a trainer post discharge.
16227120|NCT01184547|Behavioral|Standard of Care|No exercise training received.
16227121|NCT01184534|Behavioral|Video|5 minute multimedia presentation (video)
16227122|NCT01184534|Behavioral|Questionnaires|2 questionnaires pre and post procedure taking approximately 15 minutes each to complete.
16227123|NCT01184508|Drug|Placebo|Administered orally, once daily, for 12 weeks
16227124|NCT01184508|Drug|LY2300559|300 milligrams (mg) administered orally, once daily, for 12 weeks
16227125|NCT01184495|Drug|Epoetin Alfa-BioManguinhos|Subcutaneous administration of EPO-BioManguinhos
16227126|NCT01184495|Drug|Epoetin Alfa-BioSimilar|Subcutaneous administration of EPO-BioSimilar
16227161|NCT01184105|Drug|Intervention A|A single dose of 60 mg will consist of 6 sprays of the 10 mg strength spray applied topically to cervix (2 sprays) and vaginal fornices (4 sprays)
16227127|NCT01184482|Drug|cetuximab and lapatinib|"Cetuximab: 400 mg/m2 on Day 1 then 250 mg/m2 weekly
~Lapatinib: Start once daily on Day 1. Dose escalating cohorts:
~750 mg (3 tabs)
~1000 mg (4 tabs)
~1250 mg (5 tabs)"
16227128|NCT01184456|Dietary Supplement|GanedenBC30, GBI-30, PTA-6086|1 capsule per day containing 2 billion CFU of GanedenBC30, GBI-30, PTA-6086 for 90 days.
16227129|NCT01184456|Drug|Placebo|1 capsule per day for 90 days.
16227130|NCT01184443|Drug|Olanzapine|Dosing regimen is in keeping with clinical practice. Patients will typically start oral olanzapine at 2.5mg (rarely 1.25mg) daily for 1 to 2 weeks, and if tolerated and clinically indicated, are increased to 5.0mg daily. The majority of patients will remain on a maintenance dose of 5.0mg, but more agitated patients may take 7.5mg (rarely 10.0mg) daily. Patients will be tapered off as they approach/attain their ideal body weight.
16227131|NCT01184430|Device|Pulse contour cardiac output device|Goal directed volume therapy using stroke volume variation and cardiac output to guide volume therapy and inotropic support.
16227132|NCT01184417|Drug|10 mg/kg IV phenobarbital in 100 ml saline|10 mg/kg IV phenobarbital in 100 ml saline
16227133|NCT01184417|Drug|placebo|100 m l saline
16227134|NCT01184404|Drug|Bosentan|The treatment group receives a starting dose of 62.5 mg tablet bosentan twice daily for four weeks followed by 125 mg tablet of bosentan twice daily two weeks prior to and 12 weeks after surgery.
16227135|NCT01184391|Drug|DEPAKOTE® Tablets, 500 MG|1 x 500 mg tablet, under fasting conditions
16227136|NCT01184391|Drug|DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MG|1 X 500 mg Tablet, under fasting conditions.
16227137|NCT01184378|Dietary Supplement|dairy lipids and soluble milk proteins|one month formula supplementation feces are collected during a 3 days period after 15 and 30 days of formula intake
16227138|NCT01184365|Behavioral|Energy Management Program|The program content over the four sessions is structured as follows: Session 1 is an introduction to the group, important concepts, and upcoming session topics; Session 2 further elaborates on the concepts introduced in session 1 and encourages self-reflection; Session 3 is the peer to peer contact by phone or in person to assist with problems and share tips that really worked; and Session 4 concludes the program and serves to consolidate information learned.
16227139|NCT01184365|Behavioral|Energy Management Program|The goal of the EnMP-2 is to control for group effects
16227140|NCT01184352|Device|TriReme Medical, Inc. Glider(TM) PTCA Balloon Catheter|Percutaneous Coronary Interventions performed with the Glider PTCA Balloon Catheter
16227141|NCT01184339|Device|MicroPhage S. aureus/MSSA/MRSA Blood Culture Test|"In vitro diagnostic for the Identification of S. aureus and determination of MSSA or MRSA from a positive blood culture.
~Approximately 5 hour rapid test."
16227142|NCT01184326|Drug|pazopanib|
16227143|NCT01184326|Drug|everolimus|
16227144|NCT01184313|Procedure|aortic valve surgery with CPB|elective aortic valve surgery with CPB
16227145|NCT01184300|Genetic|Point-of-care genetic screening with subsequent prasugrel administration to CYP2C19*2 carriers|Patients found to carry the CYP2C19*2 allele will receive prasugrel 10 mg daily for 1 week. Non-carriers will receive clopidogrel 75 mg daily.
16227146|NCT01184287|Drug|Ranpirnase|Cycles 3 and until patient progression, on days 1,8 and 15 in a 21 day cycle
16227147|NCT01184274|Drug|SB939|"Dose Levels for Part A
~-1 - 20mg/m2 - oral - Every other day three times/week1 for three consecutive weeks, followed by one week off-dosing
~(starting dose) 25mg/m2 - oral - Every other day three times/week1 for three consecutive weeks, followed by one week off-dosing
~- 35mg/m2 - oral - Every other day three times/week1 for three consecutive weeks, followed by one week off-dosing
~- 45mg/m2 - oral - Every other day three times/week1 for three consecutive weeks, followed by one week off-dosing
~4+ - Previous level + 10mg/m2 - oral - Every other day three times/week1 for three consecutive weeks, followed by one week off-dosing"
16227148|NCT01184261|Behavioral|behavioral intervention|8 session behavioral intervention.
16227149|NCT01184248|Behavioral|Sound stimulation|Listening to sound stimuli at the lowest audible level.
16227150|NCT01184235|Drug|Pharmacological Intervention|This study will include those anticipating or receiving any pharmacological intervention
16227151|NCT01184222|Device|great occipital nerve stimulation|"Active Comparator: Arm Active SENGO The patients will be hospitalised and managed by medication withdrawal and active GONS, surgically temporarily implanted.
~Arm sham SENGO : The patients will be hospitalised and managed by medication withdrawal and sham GONS, surgically temporarily implanted."
16227152|NCT01184196|Drug|Swab area with Betadine|A swab will be taken over the operative knee before surgical site preparation is started, after preparation has taken place, and 24 hours post-surgery.
16227153|NCT01184196|Drug|Swab area with ChloraPrep|A swab will be taken over the operative knee before surgical site preparation is started, after preparation has taken place, and 24 hours post-surgery.
16227154|NCT01184183|Procedure|Comparing Accuseal Vs. Bovine Pericardial in CEA|"Accuseal patch - The Goretex Company has since designed a new patch, the Accuseal, which is marketed as decreasing the intra-operative time (i.e, having a short hemostasis time) without affecting the perioperative stroke rate.
~Bovine Pericardial patch - The Bovine Pericardial patch has been used for nearly two decades, since the late 1990s. However, studies based on retrospective review of data in which patients received the Bovine Pericardial patch, reported the clinical outcomes post-operative stroke, death, time to hemostasis and recurrent restenosis."
16227155|NCT01184170|Behavioral|overfeeding|Subjects will begin an 8-12 week high-calorie diet intervention. They will eat an additional 1000 kcal/day for two to three months, until a moderate, approximately 5% weight gain is achieved. The recommended dietary energy intake will be 1000 kcal/d more than the subject's baseline resting energy expenditure. An individualized diet plan will be developed for each subject by the study dietitian based on estimated energy requirements, and the subject's food preferences and dietary habits.
16227156|NCT01184157|Behavioral|Home screening|
16227157|NCT01184157|Behavioral|Clinic screening|
16227158|NCT01184144|Drug|Pioglitazone|Pioglitazone, 30 mg, by mouth daily for 2 weeks
16227159|NCT01184131|Other|Mentor Training|Four 2 hour sessions of Mentor Training
16227160|NCT01184118|Drug|FP 220 mcg 2 puffs BID|The design is a prospective 16-week open-label study of inhaled FP hydrofluoroalkane-propelled metered dose inhaler (HFA-MDI), 220 mcg, 4 puffs BID in 36 ICS naive asthma subjects. This is followed by a 4-week run-out period, including FP 220 mcg 2 puffs BID for 2 weeks, then either continue FP 220 mcg 2 puffs BID or discontinue FP (as tolerated), for the remaining two weeks, with subsequent transition to clinical care.
16227162|NCT01184105|Drug|Intervention B|A dose of placebo will consist of 6 sprays of the placebo spray applied topically to cervix (2 sprays) and vaginal fornices (4 sprays)
16227163|NCT01184092|Drug|Treatment A|Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).
16227164|NCT01184092|Drug|Treatment B|Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).
16227165|NCT01184092|Drug|Treatment C|Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).
16227166|NCT01184092|Drug|Treatment A|Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).
16227167|NCT01184092|Drug|Treatment C|Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).
16227168|NCT01184092|Drug|Treatment B|Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).
16227169|NCT01184092|Drug|Treatment B|Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).
16227170|NCT01184092|Drug|Treatment C|Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).
16227171|NCT01184092|Drug|Treatment A|Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).
16227172|NCT01184092|Drug|Treatment B|Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).
16227173|NCT01184092|Drug|Treatment A|Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).
16227174|NCT01184092|Drug|Treatment C|Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).
16227175|NCT01184092|Drug|Treatment C|Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).
16227176|NCT01184092|Drug|Treatment A|Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).
16227177|NCT01184092|Drug|Treatment B|Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).
16227178|NCT01184092|Drug|Treatment C|Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg tablets (Phase 2B tablets).
16227179|NCT01184092|Drug|Treatment B|Single oral dose of 10 mg CP-690,550 -10 administered as two 5 mg immediate release filmcoated tablets (Phase 3 tablets).
16227180|NCT01184092|Drug|Treatment A|Single oral dose of 10 mg tasocitinib citrate (CP-690,550-10)administered as one 10 mg immediate release tablet (ICH -commercial image tablet).
16227181|NCT01184079|Biological|quadrivalent human papillomavirus vaccine|0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 12 months
16227182|NCT01184079|Biological|quadrivalent human papillomavirus vaccine|0.5 mL of quadrivalent HPV vaccine at enrollment, 2 months, and 6 months
16227183|NCT01184066|Behavioral|ACTS Intervention|ACTS (Attitudes, Communication, Treatment, Support) Intervention is a onetime intensive 45 minute intervention delivered by a black breast cancer survivor and utilizing video, graphics, teaching tools, and supportive testimony to encourage chemotherapy adherence.
16227184|NCT01184066|Behavioral|Usual Care|Usual Care will consist of standard therapy education by a registered nurse in the treatment center. Education and support from clinicians are offered as needed throughout the course of cancer treatment at all participating medical oncology clinics.
16227185|NCT01184053|Drug|Arsenic trioxide|Arsenic trioxide - 0.25 mg/kg/day for 5 consecutive days, every 4 weeks.
16227186|NCT01184040|Behavioral|VIP CM|Participants will receive progressively increasing CM for walking 10,000 steps per day over 4 days prior to visit as verified by the pedometer.
16227187|NCT01184027|Behavioral|nutrition /swallowing counseling|general nutrition and swalling information
16227188|NCT01184027|Behavioral|G-tube/swallowing intervention|Patient will have active swallowing intervention with an SLP
16227189|NCT01184027|Behavioral|nutrition /swallowing intervention|Patient will have active (daily) nutrition and swallowing intervention based on patients individual needs.
16227190|NCT01184014|Drug|NPH insulin plus Complete Insulin Orders|NPH dosed per study-specific algorithm which incorporates total daily dosage of steroid to determine NPH dose. Complete insulin orders include background, meal-time and correction factor.
16227191|NCT01184014|Drug|Complete Insulin Orders|3-part insulin which includes background, meal-time and correction factor
16227192|NCT01184001|Drug|Treatment A|Single dose of tasocitinib (CP-690,550) 10 mg under fed conditions.
16227193|NCT01184001|Drug|Treatment B|Single dose of tasocitinib (CP-690,550) 10 mg under fasted conditions.
16227194|NCT01184001|Drug|Treatment B|Single dose of tasocitinib (CP-690,550) 10 mg under fasted conditions.
16227195|NCT01184001|Drug|Treatment A|Single dose of tasocitinib (CP-690,550) 10 mg under fed conditions.
16227196|NCT01183962|Dietary Supplement|Vitamin D|Vitamin D 3000 IU daily
16227197|NCT01183962|Other|No medication|No intervention
16227198|NCT01183949|Drug|AT7519M|"Part A: Nine patients will receive AT7519M as an intravenous infusion on days 1, 4, 8 and 11 of a three week cycle. The starting dose of AT7519M will be 21mg/m^2/dose and will be increased to 27mg/m^2/dose during subsequent cycles in the absence of AT7519M-related toxicities.
~Part B: Amendment clarified there will be no further exploration of AT7519M as a monotherapy.
~Part C: Amendment modified dose escalation to a conventional 3 + 3 design with a maximum total of 14 patients will be treated at the maximum tolerated dose."
16227199|NCT01183949|Drug|Bortezomib|Part C will treat between 3-26 patients with a combination of bortezomib and AT7519M in a dose escalation design. The starting doses for the dose escalation are bortezomib 1 mg/m2 and AT7519M 14 mg/m2.
16227200|NCT01183936|Procedure|2-cm margin|Patients with CMM treated with a surgical safety margin of 2-cm in the surrounding skin and down to the fascia.
16227201|NCT01183936|Procedure|4-cm margin|Patients with CMM treated with a surgical safety margin of 4-cm in the surrounding skin and down to the fascia.
16227202|NCT01183923|Other|Broccoli Sprouts|Broccoli Sprouts will be eaten daily in a sandwich form during the intervention period for broccoli sprouts.
16227203|NCT01183923|Other|Alfalfa Sprouts|Alfalfa sprouts will be eaten daily in a sandwich form during the intervention period for alfalfa sprouts.
16227204|NCT01183910|Dietary Supplement|Citrus Bioflavanoid Blend|Pill Taken Twice a Day
16227205|NCT01183910|Dietary Supplement|Calcium Carbonate|Oral Tablet Taken Twice a Day
16227206|NCT01183897|Biological|3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic|"This phase II, open-label, single arm trial assesses the anti-NB activity of high-dose 3F8 (80 mg/m2/day), which is used in cycles 1-2, with return to standard 3F8 dosage (20 mg/m2/day) in subsequent cycles.Clinical results will be compared to those in the predecessor trials which used only the standard 3F8 dosage. Starting with A(6), patients no longer receive high-dose 3F8 but receive only standard dose 3F8 (20mg/m2/day) for all cycles The patients have primary refractory BM disease. Protocol treatment is through 24 months.
~Real-time quantitative RT-PCR63-65 will be used to assess MRD in BM. 13-cis-retinoic acid is started no later than after cycle 4 (i.e., after response is scored), but sooner if CR is achieved after cycles 1, 2, or 3, or if early HAMA develops."
16227207|NCT01183884|Biological|3F8/GM-CSF Immunotherapy Plus 13-Cis-Retinoic Acid|"3F8 (80 mg/m2/day), which is used in cycles 1-2, with return to standard 3F8 dosage (20 mg/m2/day) in subsequent cycles .Clinical results will be compared to those in the predecessor trials which used only the standard 3F8 dosage.
~Starting with A(6), patients no longer receive high-dose 3F8 but receive only standard dose 3F8 (20 mg/m2/day) for all cycles. The patients are in > or = to 2nd CR/VGPR and at high risk for additional relapse. Real-time quantitative RT-PCR63-65 will be used to assess MRD in BM. 13-cis-retinoic acid is started after cycle 2."
16227208|NCT01183871|Procedure|Monitoring of cerebral oxygenation|The internal jugular vein will be cannulated using ultrasound guidance in a cephalad direction, using the Seldinger J-shaped guidewire and it will be advanced only for 2-3 cm beyond the needle insertion site to avoid vascular injury to the jugular bulb. At which point the catheter is advanced until resistance is met at the jugular bulb, usually about 15 cm. The catheter is then pulled back 0.5-1.0 cm so that the catheter does not continue to abut the roof of the jugular bulb and to minimize the cephalad vascular impact with head movement, thereby reducing the risk of vascular injury. Skull x-ray will be used to confirm placement.
16227209|NCT01183858|Drug|Erlotinib [Tarceva]|Single daily oral dose
16227210|NCT01183845|Procedure|Colon Capsule Endoscopy|Ileocolonic endoscopy scheduled; then colon capsule endoscopy performed.
16227211|NCT01183819|Behavioral|Space Fortress|Space Fortress sessions 3 times a week for 12 weeks
16227212|NCT01183819|Behavioral|Aerobic Exercise|Aerobic Exercise 4 times a week for 12 weeks
16227213|NCT01183819|Behavioral|Stretching|Stretching/Toning exercise 4 times a week for 12 weeks.
16227214|NCT01183819|Behavioral|Control Games|Control games session 3 times a week for 12 weeks
16227215|NCT01183806|Drug|Rivastigmine|All patients start on a 5-cm2 rivastigmine transdermal patch and their dose is progressively increased
16227216|NCT01183806|Other|Exercise training program|Exercise training program
16227217|NCT01183793|Radiation|Barium follow-through and MR-enterography|Assessment of the lack of difference between surgical and MR enterography small bowel length measurement with a comparison sample test
16227218|NCT01183780|Biological|Ramucirumab|8 milligrams / kilogram (mg/kg) administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision
16227219|NCT01183780|Biological|Placebo|Administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision
16227220|NCT01183780|Drug|Irinotecan|180 milligrams/square meter (mg/m^2) administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision
16227221|NCT01183780|Drug|Folinic Acid|400 mg/m^2 administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision
16227222|NCT01183780|Drug|5-Fluorouracil|400 mg/m^2 bolus immediately followed by 2400 mg/m^2 continuous infusion every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision
16227223|NCT01183767|Drug|Epigallocatechin-Gallate|EGCG in a dosage of up to 10mg/kg body weight
16227224|NCT01183767|Drug|Placebo|
16227225|NCT01183728|Other|Autologous bone marrow mesenchymal stem cells (MSV)|Bone marrow collection from patient, mesenchymal cells isolation and expansion under GMP conditions following the IBGM-Valladolid protocol (MSV). Autologous MSV implantation by articular injection.
16227226|NCT01183715|Drug|PF-05161704 or placebo|PF-05161704 will be administered as an extemporaneously prepared suspension in the initially planned dose range of 1.5 mg to 300 mg. Correspondingly, placebo doses will be administered as suspension
16227227|NCT01183715|Drug|PF-05161704 or placebo|PF-05161704 will be administered as an extemporaneously prepared suspension in the initially planned dose range of 1.5 mg to 300 mg. Correspondingly, placebo doses will be administered as suspension
16227228|NCT01183702|Procedure|LASIK surgery|Participants have received LASIK surgery and their eyes are healthy.
16227229|NCT01183702|Other|No Intervention|Participant has healthy eyes not altered by LASIK surgery.
16227230|NCT01183689|Behavioral|Small Behavior Changes|"The Self-Regulation Plus Small Behavior Changes Intervention will focus on making small changes in diet and physical activity on a daily basis to prevent weight gain.
~Diet: The dietary approach used in this group is to identify small changes in what and how much participants eat each day. The general concept is that these are small, manageable changes that will produce small reductions in overall intake and can easily be made on a daily basis and maintained over time.
~Exercise: At the start of the program, participants will be given a pedometer and asked to record their current or baseline number of steps. They will then be given the goal of increasing their daily steps by 2000 steps per day over this baseline level."
16227231|NCT01183689|Behavioral|Large Behavior Changes|"The focus of this intervention group will be on periodically making large changes in diet and physical activity, with the goal of losing 5-10 pounds to buffer against the weight gain that often occurs during young adulthood.
~Diet: Individuals with a BMI of 21-24.9 kg/m2 will be encouraged to lose 5 pounds; those with a BMI of 25-30 kg/m2 will be encouraged to lose 10 pounds.
~Exercise: The Large Changes group will be instructed to gradually increase their minutes of physical activity until achieving 250 minutes per week (5 days/week with 50 minutes per day) using activities similar in intensity to brisk walking."
16227232|NCT01183676|Drug|DEPAKOTE® Tablets, 500 MG|1 x 500 mg Tablet, under fed conditions
16227233|NCT01183676|Drug|DIVALPROEX SODIUM DELAYED-RELEASE TABLETS, USP, 500 MG|1 x 500 mg Tablet, under fed conditions
16227234|NCT01183663|Drug|Lenalidomide|Starting dose 10 mg by mouth daily for 21 days of a 28 day cycle.
16227235|NCT01183663|Drug|Bevacizumab|Starting dose: 5 mg/kg by vein every 2 weeks of a 28 day cycle.
16227236|NCT01183663|Drug|Sorafenib|Starting dose: 200 mg by mouth daily for 28 a day cycle.
16227237|NCT01183663|Drug|Temsirolimus|Starting dose: 15 mg by vein every week for a 28 day cycle.
16227238|NCT01183663|Drug|Lenalidomide|Starting dose: 5 mg by mouth daily for 14 days of a 21 day cycle.
16227239|NCT01183663|Drug|Oxaliplatin|Starting dose: 65 mg/m2 by vein on day 1 of a 21 day cycle.
16227240|NCT01183663|Drug|Leucovorin|400 mg/m2 by vein on day 1 of a 21 day cycle.
16227241|NCT01183663|Drug|5-fluorouracil|400 mg/m2 by vein through ambulatory pump on days 1-2 of a 21 day cycle.
16227242|NCT01183650|Drug|Tadalafil|5 mg, administered orally, daily for 10 days
16227243|NCT01183637|Device|Kensey Nash Corp. Cartilage Repair Device|To perform the Cartilage Repair Device implantation procedure, the surgeon first removes the damaged cartilage. Then, the surgeon creates a cylindrical hole in the bone below the area of damaged cartilage. The Cartilage Repair Device is then implanted into the hole so that the surface is level with the surrounding native cartilage. The Cartilage Repair Device will then absorb blood and bone marrow from the bone to begin the healing process.
16227244|NCT01183637|Procedure|Microfracture|To perform the microfracture technique, the surgeon will first remove the damaged cartilage. Then, the surgeon will make a number of small fractures in the bone below the area of damaged cartilage. The fractures cause the bone to bleed and a clot to form over the exposed bone. Over time, the clot forms a layer of fibrocartilage over the bone.
16227245|NCT01183624|Other|Herbal Patch|1 herbal patch applied for approximately 8 hours per day for 14 days
16227246|NCT01183624|Other|Placebo Patch|Control patch with no herbal ingredients
16227247|NCT01183611|Biological|Experimental recombinant hepatitis B vaccine, HBIG|Experimental 10mcg/0.5 ml recombinant hepatitis B vaccine and 200IU HBIG
16227248|NCT01183611|Biological|Active Comparator hepatitis B vaccine|Active Comparator 10mcg/0.5 ml of recombinant hepatitis B vaccine，200IU HBIG
16227249|NCT01183611|Biological|Experimental recombinant hepatitis B vaccine|Experimental 10mcg/0.5 ml of recombinant hepatitis B vaccine
16227250|NCT01183611|Biological|Active Comparator recombinant hepatitis B vaccine.|Active Comparator 10mcg/0.5 ml of recombinant hepatitis B vaccine.
16227251|NCT01183611|Biological|Placebo Comparator recombinant hepatitis B vaccine|Placebo Comparator 10mcg/0.5 ml of recombinant hepatitis B vaccine.
16227252|NCT01183598|Drug|tocilizumab [RoActemra/Actemra]|maintenance dose
16227253|NCT01183585|Drug|RO4917838 and Rosuvastatin|multiple oral doses of RO4917838 and single oral dose of Rosuvastatin
16227254|NCT01183572|Dietary Supplement|Multivitamins, Folic Acid, and Iron|Daily oral dose containing 2500 IU Vitamin A, 1.4 mg Vitamin B1, 1.4 mg Vitamin B2, 2.6 mg Vitamin B12, 1.9 mg Vitamin B6, 18 mg Niacin, 70 mg Vitamin C, 14.9 IU Vitamin E, 30 mg elemental iron, 0.4 mg folic acid
16227255|NCT01183572|Dietary Supplement|Folic Acid and Iron|Daily oral dose of 30 mg elemental iron, 0.4 mg folic acid
16227256|NCT01183572|Dietary Supplement|Folic Acid|Daily oral dose of 0.4 mg folic acid
16227257|NCT01183559|Drug|Vandetanib|Vandetanib 100mg orally escalating to doses of 200 mg daily 7 days a week until completion of radiation therapy
16227258|NCT01183559|Drug|5 Fluorouracil (FU)|5-FU 225 mg/m2/day continuous infusion over96 hours during radiation therapy
16227259|NCT01183559|Drug|Carboplatin|Carboplatin AUC=5 days 1 and 29 during radiation therapy
16227260|NCT01183559|Drug|Paclitaxel|Paclitaxel 50 mg/m2 days 1, 8, 15, 22, 29 during radiation therapy
16227261|NCT01183559|Radiation|External Beam Radiation Therapy (RT)|External Beam Radiation Therapy(XRT)to a total dose of 4,500 centiGray (cGy) (180 cGy fractions daily) Monday through Friday for five weeks
16227262|NCT01183533|Drug|Alteplase (iv t-PA)|0.9 mg/kg (maximum of 90 mg) IV t-PA will be administered with 10% bolus given over 1 minute, the rest given as an infusion over the remaining hour.
16227263|NCT01183520|Dietary Supplement|Omega-3 fish oil provided by salmon|Eating 3 different amounts of provided salmon twice a week for four weeks
16227264|NCT01183507|Behavioral|NIA intervention|The NIA physical activity intervention is of moderate intensity and will consist of aerobic, strength, flexibility, and balance training, with a target duration of 120 minutes per week.
16227265|NCT01183507|Behavioral|TSE|The TSE intervention is also of moderate intensity and target duration of 120 minutes per week and will consist of exercises that closely mimic functional tasks, such as vacuuming, stair ascent and descent, and lifting a weighted laundry basket.
16227266|NCT01183494|Drug|FOLFIRI, Avastin, Irinotecan|Patients will be treated with the FOLFIRI regimen plus bevacizumab. Irinotecan will be administered at doses higher than the standard dose in patients with the UGT1A1*1/*1 and UGT1A1*1/*28 genotypes, while the doses of infusional 5-FU/LV and bevacizumab will remain unchanged.
16227267|NCT01183481|Drug|Aprepitant|Patients will be given a single dose of Aprepitant 125 mg on Day 0 (at least one hour before on the day of RT) followed by 80 mg of Aprepitant once daily in the mornings on Days 1 and 2 following the radiation treatment.
16227268|NCT01183481|Radiation|Palliative radiation therapy|Moderately emetogenic palliative radiation therapy (RT) will be administered to all patients on the study.
16227269|NCT01183481|Drug|Granisetron|Patients will be given a single dose of both Granisetron 2 mg orally on Day 0 (at least one hour before on the day of RT).
16227270|NCT01183468|Biological|Aralast NP 45 mg dose|- 45 mg/kg/week
16227271|NCT01183468|Biological|Aralast NP 90 mg dose|- 90 mg/kg/week
16227272|NCT01183468|Biological|Aralast NP 180 mg dose|- 180 mg/kg/week
16227273|NCT01183455|Drug|Aralast NP|Participants will receive IV infusions of Aralast NP (90mg/kg) once a week for 12 weeks.
16227274|NCT01183455|Drug|Placebo|Participants will receive IV infusions of placebo once a week for 12 weeks.
16227275|NCT01183442|Drug|vitamin D|orally administered 2800 IU of vitamin D or placebo daily
16227346|NCT01182805|Device|Echocardiography machine GE Vivid E9|Each subject will undergo echocardiography using a conventional echocardiography machine to evaluate the early diastolic mitral annular velocity (E-prime) using tissue Doppler as a standard measure of diastolic function.
16229000|NCT01170299|Radiation|selective external radiation therapy|
16227276|NCT01183429|Drug|3F8 and 13-cis-retinoic acid|3F8 is dosed at 80 mg/m2/day (cycles 1-2) or 20 mg/m2/day (cycles 3 and beyond) and infused iv over 30-90 minutes. 13-cis-retinoic acid is dosed at 160 mg/m2/day, divided into two doses, x14 days. If a dose is missed, it can be made up at the end of the cycle. It is not taken on same days as 3F8. *High-dose 3F8 will be administered only for patients enrolled on protocol from A(0) to A(7). Starting with A(8), patients receive standard dose (20mg/m2/day) during cycles 1 and 2.
16227277|NCT01183416|Drug|3F8 monoclonal antibody and 13-cis-Retinoic Acid|A cycle consists of treatment with 3F8 for 5 days. GMCSF is started 5 days in advance of each 3F8 cycle. The break between end of a cycle of 3F8/GM-CSF and start of next cycle is 2-to-4-weeks through 4 cycles; subsequent breaks are ~6-8 weeks. 13-cis-retinoic acid is started after cycle 2.
16227278|NCT01183390|Drug|Anastrozole|1 mg Tablets
16227279|NCT01183390|Drug|Anastrozole|1 mg Tablets
16227280|NCT01183364|Drug|STA-9090 (ganetespib) with Docetaxel|One treatment cycle will consist of weekly treatments for 2 weeks followed by a 1-week rest period. Treatment cycles will be repeated every 3 weeks. STA-9090 will be administered on Days 1 and 8 of each cycle and docetaxel will be administered on Day 1 of each cycle. Each agent will be administered as a separate 1-hour intravenous infusion.
16227281|NCT01183351|Behavioral|Psychosocial intervention|Multidisciplinary Intervention for challenging behavior in patients with Dementia (MID) is developed in clinical practice in nursing homes as an answer to the need of a systematic and simple tool for the nursing home health workers to meet agitation. The model is based on the theoretical framework of cognitive behavioural therapy (CBT) where human behaviour is understood as always acting under the influence of biological, social and psychological factors. The systematic and structured approach of CBT to problem solving is central and is transformed in the model to meet the specific characteristics of challenging behaviour in dementia.
16227282|NCT01183325|Device|Proceed Ventral Patch placement|Placement of a Proceed Ventral Patch for umbilical and small ventral hernias less than 3cm diameter with and without laparoscopic control
16227283|NCT01183312|Drug|Flumazenil|Sublingual flumazenil
16227284|NCT01183299|Other|Dietary salt intake|
16227285|NCT01183286|Behavioral|CFFONE|A password-protected, secure website, which can be accessed via a web capable cell phone. The website contains age appropriate medical and behavioral information, disease management tools and social networking features for adolescents and young people who have Cystic Fibrosis.
16227286|NCT01183286|Behavioral|CF website|A CF-related educational website which has some areas of CF information and services relevant to adolescents.
16227287|NCT01183273|Procedure|Microlaparoscopic gastric bypass|microlaparoscopic gastric bypass will be performed using standard of care procedure.
16227288|NCT01183273|Procedure|Laparoscopic Surgery|laparoscopic gastric bypass will be performed using standard of care procedure.
16227289|NCT01183260|Device|Trabecular Metal Revision Cup|Revision of the acetabular cup
16227290|NCT01183260|Device|Trabecular Metal Modular Cup|Revision of the acetabular cup
16227291|NCT01183247|Drug|Rapamycin|Add rapamycin de novo to tacrolimus and MMF
16227292|NCT01183247|Drug|Everolimus|Add everolimus de novo to tacrolimus and MMF
16227293|NCT01183247|Drug|Prednisone|Add prednisone de novo to tacrolimus and MMF
16227294|NCT01183234|Drug|SPD544|two 30mg capsules, single oral dose
16227295|NCT01183234|Drug|Methylphenidate hydrochloride|one 60mg capsule, single oral dose
16227296|NCT01183221|Drug|Syntocinon|One dose of 24 IU (3 sprays/nostril)
16227297|NCT01183221|Drug|Placebo|Intranasal Placebo
16227298|NCT01183208|Drug|Intervention A|A single dose of 3 mg will consist of 3 sprays of the 1 mg strength spray applied topically to cervix (1 spray) and vaginal fornices (2 sprays)
16227299|NCT01183208|Drug|Intervention B|A single dose of 30 mg will consist of 3 sprays of the 10 mg strength spray applied topically to cervix (1 spray) and vaginal fornices (2 sprays)
16227300|NCT01183208|Drug|Intervention C|A single dose of 150 mg will consist of 15 sprays of the 10 mg strength spray applied topically to cervix (5 sprays) and vaginal fornices (10 sprays)
16227301|NCT01183208|Drug|Intervention D|A dose of placebo will consist of 3 sprays of the placebo spray applied topically to cervix (1 spray) and vaginal fornices (2 sprays)
16227302|NCT01183208|Drug|Intervention E|A dose of placebo will consist of 15 sprays of the placebo spray applied topically to cervix (5 sprays) and vaginal fornices (10 sprays)
16227303|NCT01183182|Device|ActiSight Needle Guidance System|Three different groups of patients defined per lesion size
16227304|NCT01183169|Drug|Alisporivir|ALV 200 mg soft gel capsules administered orally
16227305|NCT01183169|Drug|Peginterferon alfa-2a|PEG 180 μg administered via subcutaneous (s.c.) injection once weekly
16227306|NCT01183169|Drug|Ribavirin|RBV 200 mg tablets (weight-based dose: < 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose
16227307|NCT01183169|Drug|Placebo|ALV placebo soft gel capsules administered orally
16227308|NCT01183156|Behavioral|Re-invitation letter|Re-invitation letter sent 6 weeks prior to prespecified screening colonoscopy appointment date and followed by reminder letter within 3 weeks if no response is received.
16227309|NCT01183156|Behavioral|Invitation to educational meeting|Invitation will be sent 6 weeks prior to educational meeting date and followed by a reminding letter 3 weeks later. Educational meetings will be held in a local culture developement centers and conducted by a medical team responsible for the Polish Colorectal Cancer Screening Program. The aim of the meeting is to overcome barriers to screening colonoscopy. The program of the meeting is tailored to individual needs, doubts, and concerns of the participating group as assessed using brief survey at the beginning of the meeting. The major points to be discussed are: risk and benefit of screening, colorectal cancer risk, pain and sedation, preparation to colonoscopy, consecutive stages of the procedure, comfort and embarrassment.
16227310|NCT01183143|Drug|GONAL-f®|GONAL-f® will be administered subcutaneously to subjects between Day 2 and Day 5 of their cycle with a starting dose of 75 International Units (IU) per day for subjects who undergo ovulation induction (OI)/artificial insemination (IUI) and between 150 and 225 IU per day for subjects who undergo in-vitro fertilization (IVF). For subjects who undergo OI/IUI, the dose will be increased by 37.5 IU after Day 14 up to Week 4 if no ovarian response is observed.
16227410|NCT01182272|Other|laboratory biomarker analysis|
16227411|NCT01182272|Procedure|neoadjuvant therapy|
16227412|NCT01182272|Procedure|therapeutic conventional surgery|
16227311|NCT01183130|Device|Compliance monitoring with electronic device|Electronic compliance monitoring with monitoring device (Pharma DDSi, Stora Enso) is used in control group (n=6) and device with mobile phone in intervention group (n=6). Patients in intervention group send every day the information of their medication intakes with the mobile phone to the clinic. This intervention is tested in pilot study (n=2-3) before the actual study begins.
16227312|NCT01183117|Device|SM-01|SM-01 is a self-expandable, crush recoverable stent with a diameter larger than that of the arterial lumen. The stent is indicated for use in a vessel with a diameter 1 to 2 mm smaller than the nominal stent diameter. This stent will open to the diameter of the artery and will continue to apply expanding force on the artery.
16227313|NCT01183117|Device|PTA|balloon angioplasty
16227314|NCT01183104|Drug|Sitagliptin|Starting dose for sitagliptin is 50mg per day, can be increased up to 100mg (25-50mg; estimate glomerular filtration rate (eGFR) 30=< <50).
16227315|NCT01183104|Drug|Glimepiride|Starting dose for glimepiride is 0.5mg per day, can be increased up to 6.0mg
16227316|NCT01183091|Procedure|Ablation of atrial fibrillation|Ablation of atrial fibrillation
16227317|NCT01183078|Procedure|free-hand|Free-hand technique utilizes x-rays to find screw holes.
16227318|NCT01183078|Procedure|Wand technique|Wand technique is utilized to find screw holes.
16227319|NCT01183065|Drug|Pralatrexate With Vitamin B12 and Folic Acid|Patients will be treated with 30 mg/m2 of pralatrexate intravenously once weekly for 3 weeks in a 4 week cycle with vitamin supplementation. Patients will take 1.0-1.25 mg oral folic acid on a daily basis. Folic acid should be initiated during the 10-day period preceding the first dose of pralatrexate and dosing will be continued during the full course of therapy and for 30 days after the last dose of pralatrexate. Patients will also receive a vitamin B12 (1 mg) intramuscular injection no more than 10 weeks prior to the first dose of pralatrexate and every 8-10 weeks thereafter. Subsequent vitamin B12 injections may be given the same day as treatment with pralatrexate.
16227320|NCT01183052|Other|Training|20 sessions of training
16227321|NCT01183039|Other|Training|20 sessions of training
16227322|NCT01183013|Drug|Pioglitazone 15 mg|Pioglitazone Capsules 15 mg once daily for 30 weeks followed by Pioglitazone Capsules 30 mg once daily for up to 54 weeks
16227323|NCT01183013|Drug|Pioglitazone 45 mg|Pioglitazone Capsules 30 mg once daily for 6 weeks followed by Pioglitazone Capsules 45 mg once daily for up to 78 weeks
16227324|NCT01183013|Drug|Pioglitazone 30 mg|Pioglitazone Capsules 30 mg once daily for up to 84 weeks
16227325|NCT01183013|Drug|Linagliptin 5mg / Pioglitazone 45 mg FDC|Linagliptin 5mg low dose / Pioglitazone 30 mg Tablets once daily for 6 weeks followed by Linagliptin 5mg low dose / Pioglitazone 45 mg FDC Tablets once daily for up to 78 weeks
16227326|NCT01183013|Drug|Linagliptin 5mg / Pioglitazone 30 mg FDC|Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 84 weeks
16227327|NCT01183013|Drug|Linagliptin 5mg|Linagliptin 5mg Tablets low dose once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks
16227328|NCT01183013|Drug|Linagliptin 5mg / Pioglitazone 15 mg FDC|Linagliptin 5mg low dose / Pioglitazone 15 mg FDC Tablets once daily for 30 weeks followed by Linagliptin 5mg low dose / Pioglitazone 30 mg FDC Tablets once daily for up to 54 weeks
16227329|NCT01183000|Procedure|Closure of the peritoneum at cs|Injection of 5 mg Marcaine (anesthetic solution) to the leg
16227330|NCT01182987|Behavioral|Dementia Care Management|"The SCAN Memory Program is a care management program for cognitively-impaired SCAN members and for their informal/family caregivers. The program includes collaboration between SCAN Health Plan, partnering medical groups, and community organizations.
~Program activities include: 1) telephonic-structured assessments with informal caregivers conducted by SCAN Memory Program care managers; 2) problem identification as a result of these assessments; and 3) pre-established protocols and procedures for problem resolution."
16227331|NCT01182974|Drug|paracetamol|1 gr of paracetamol PO/PZ/PR
16227332|NCT01182974|Drug|dypirone|1 gr PO/PZ/PR/IM
16227333|NCT01182961|Other|gait training|subjects will walk on a treadmill while virtual obstacles will be displayed using a head mounted device
16227334|NCT01182961|Other|gait training 2|subjects will walk on a treadmill under a progressive intensive gait protocol
16227335|NCT01182961|Other|exercise group|standard of care exercise group to improve strength and balance
16227336|NCT01182948|Behavioral|Aerobic Training|The aerobic training group will exercise on cardiovascular training equipment. The workload will be gradually increased up to 60% of the reserve heart rate. Subjects will exercise 3 times per week for 60 min in the Fitness Centre of the Exercise and Sport Science School. Training will be carried out in small groups, under the supervision of personal trainers. During the study subjects will be instructed to follow an isocaloric diet.
16227337|NCT01182948|Behavioral|Resistance Training|The resistance training group will perform different exercises on weight machines and free weights to exercise upper and lower extremity muscles. Participants will perform 8-10 different exercises each session, alternating abdominal, upper and lower extremity exercises. Subjects will exercise 3 times per week for 60 min in the Fitness Centre of the Exercise and Sport Science School. Training will be carried out in small groups, under the supervision of personal trainers. During the study subjects will be instructed to follow an isocaloric diet.
16227338|NCT01182922|Behavioral|Invitation letter|Invitation letter sent 6 weeks prior to prespecified screening colonoscopy appointment date and followed by reminder letter within 3 weeks if no response is received.
16227339|NCT01182883|Drug|IMC-A12|
16227340|NCT01182883|Drug|Temsirolimus|
16227341|NCT01182870|Drug|choleclaciferol|800-6000 IU cholecalciferol per day
16227342|NCT01182844|Dietary Supplement|Lactobacillus casei Shirota|3 bottles of Yakult(R) light per day
16227343|NCT01182831|Procedure|percutaneous fluoro guided celiac plexus neurolysis|It is percutaneous injection of neurolytic agent in and around the celiac ganglion
16227344|NCT01182831|Procedure|EUS guided neurolysis|It is injection of neurolytic agent in and around the celiac ganglion using an echo endoscope.
16227345|NCT01182805|Device|Echocardiography system Ultra DCI Model 5000|Each subject will undergo scanning using the investigational echocardiography system (Ultra DCI Model 5000)to measure Diastolic Circumferential Strain Rate during Isovolumic Relaxation (DCSR-IVR) as novel measure of diastolic function.
16227498|NCT01181609|Drug|bevacizumab [Avastin]|5 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks according to the chemotherapy regimen
16227347|NCT01182805|Device|Diastolic function assessment|Each subject will undergo standard echocardiographic measure of the mitral inflow pattern and invasive catheter-derived measure of left ventricular end-diastolic pressure to determine their diastolic function. This evaluation will be used as the gold standard for this study.
16227348|NCT01182792|Dietary Supplement|Vitamin C and E|1 month, 1g Vitamin C and 400 IE Vitamin E or Acute, 1g Vitamin C (in the offspring)
16227349|NCT01182792|Dietary Supplement|Placebo|1 month Placebo
16227350|NCT01182779|Radiation|Carbon ion|"Arm A (carbon ion therapy):
~Total dose to the PTV2 - 45 Gy E in 3 Gy E /d, 4-6 days a week, 15 fractions Total dose to the PTV1 - 63 Gy E ± 5%, further 5-7 fractions a 3 Gy E."
16227351|NCT01182779|Radiation|Protons|"Arm B (proton therapy):
~Total dose to the PTV2 - 50 to 56 Gy E in 2 Gy E /d, 4-6 days a week, 28 fractions Total dose to the PTV1 - 72 Gy E ± 5%, further 6-9 fractions a 2 Gy E."
16227352|NCT01182766|Drug|Topiramate with brief behavioral enhancement therapy|high-dose topiramate (up to 250 mg/day), or low-dose topiramate (up to 125 mg/day)
16227353|NCT01182766|Drug|Placebo with brief behavioral enhancement therapy|placebo
16227354|NCT01182753|Radiation|carbon ion therapy|"Arm A (carbon ion therapy):
~Total dose to the PTV2 - 45 Gy E in 3 Gy E /d, 4 - 6 days a week, 15 fractions Total dose to the PTV1 - 60 Gy E ± 5%, further 4 - 6 fractions a 3 Gy E."
16227355|NCT01182753|Radiation|proton therapy|"Arm B (proton therapy):
~Total dose to the PTV2 - 50 to 56 Gy E in 2 Gy E /d, 4 - 6 days a week, 25 - 28 fractions Total dose to the PTV1 - 70 Gy E ± 5%, further 6 - 10 fractions a 2 Gy E."
16227356|NCT01182727|Drug|salsalate|Salsalate will be administered in 500 mg tablets. Salsalate will be administered in two divided doses of 2 grams in the morning and 2 grams in the evening. Salsalate will be administered for a total of 6 weeks. If a participant is not able to tolerate the target dose of 4 grams per day then 500 mg reductions will be made in a stepwise fashion until tolerated or a minimum dose of 2 grams per day is achieved.
16227357|NCT01182714|Procedure|immediate removal of in-dwelling catheter|
16227358|NCT01182714|Procedure|24 hours delayed removal of catheter|
16227359|NCT01182701|Behavioral|Cognitive behavioral training|The behavioral training group will be involved six group sessions focusing on cognitive behavioral training for stress and mood management, cognitive restructuring, empowerment, values clarification, problem solving and decision making via a manualized program
16227360|NCT01182675|Drug|Transplant Conditioning with Mobilization Only|Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0 Transplant
16227361|NCT01182675|Drug|Transplant Conditioning with Mobilization and Alemtuzumab|Day -7: Alemtuzumab 0.3 mg test dose then 0.3 mg/kg IV; Day -6: Alemtuzumab 0.3 mg/kg IV; Day -5: Alemtuzumab 0.3 mg/kg IV; Day -4: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -3: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -2: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day -1: Filgrastim (G-CSF) 5 mcg/kg IV q12 hours; Day 0: Plerixafor 240 mcg/kg subcutaneous 9-12 hours prior to transplant; Day 0: Transplant
16227362|NCT01182662|Other|Human umbilical cord-derived MSCs and cyclosporin A|1.0E+6 MSC/kg, IV drop and repeat to apply in trimonthly for 2 cycle and cyclosporin A 5mg/kg po for 12 months
16227363|NCT01182662|Other|cyclosporin A|cyclosporin A 5mg/kg po for 12 months
16227364|NCT01182649|Device|coronary stent|coronary angioplasty with stent implantation
16227365|NCT01182649|Device|stent|coronary angioplasty with stent implantation
16227366|NCT01182636|Drug|Adapalene|0.1% Topical Gel
16227367|NCT01182636|Drug|Differin®|0.1% Topical Gel
16227368|NCT01182636|Drug|Placebo|Gel Base
16227369|NCT01182623|Other|Observation of surface patterns of polyps|examination of the surface patterns of polyps using FICE and indigo carmine dye spray
16227370|NCT01182610|Drug|Panitumumab|Panitumumab 9mg/kg on Days 1, 22, and 43
16227371|NCT01182610|Drug|Paclitaxel|Paclitaxel 200mg/m2 on Days 1 and 22
16227372|NCT01182610|Drug|Carboplatin|Carboplatin AUC=6 on Days 1 and 22
16227373|NCT01182610|Drug|5FU|5FU 225mg/m2/day on Days 1-15 and 22-36
16227374|NCT01182597|Drug|Pantoprazole (Pantoloc)|Pantoprazole (Pantoloc) 3.3mg/hr for 72hrs
16227375|NCT01182597|Drug|Lansoprazole (Takepron OD)|Lansoprazole (Takepron OD) 30mg q12h PO
16227376|NCT01182558|Other|Hypothenar muscle activation--maximum, voluntary, isometric|"Each subject will perform maximum, voluntary, isometric muscle activation (of the target muscle) for each of various durations (single brief muscle twitch, 2 seconds, 5 seconds, 10 seconds, and 20 seconds [two epochs of 10 seconds of muscle activation with 1-2 seconds of rest between the two epochs])."
16227377|NCT01182558|Other|Thenar muscle activation--maximum, voluntary, isometric|"Each subject will perform maximum, voluntary, isometric muscle activation (of the target muscle) for each of various durations (single brief muscle twitch, 2 seconds, 5 seconds, 10 seconds, and 20 seconds [two epochs of 10 seconds of muscle activation with 1-2 seconds of rest between the two epochs])."
16227378|NCT01182558|Other|EDB muscle activation--maximum, voluntary, isometric|"Each subject will perform maximum, voluntary, isometric muscle activation (of the target muscle) for each of various durations (single brief muscle twitch, 2 seconds, 5 seconds, 10 seconds, and 20 seconds [two epochs of 10 seconds of muscle activation with 1-2 seconds of rest between the two epochs])."
16227379|NCT01182558|Other|Relaxation of muscle|The muscle on the opposite side will be maintained at rest.
16227380|NCT01182545|Procedure|Ventilation|Mechanical ventilation was conducted in all the patients with a Datex-Ohmeda Aestiva/5 Smart Ventilator (Madison, WI) through a rebreathing circuit incorporating a CO2 absorber, a heat and moisture exchanger using volume-controlled mode with an inspiratory to expiratory ratio of 1:2.5, and positive end-expiratory pressure (PEEP) of 5 cm H2O. Plateau pressure was kept as low as possible with an upper limit of 30 cm H2O, and the absence of auto-PEEP was ensured by a drop of the expiratory flow to zero on the flow-time curve.
16227381|NCT01182532|Other|Western therapy|"Symptomatic treatment: vitamin B, vitamin C, mouth care and skin care.
~Adopting physical cooling therapy, including physical cooling paste or warm bathing, when patient's body temperature is lower than 38.5 degree Celsius;
~Using Ibuprofen suspension when patient's temperature higher than 38.5 degree Celsius;"
16227446|NCT01181973|Drug|pegvisomant|One 1-mL subcutaneous injection at 30 mg/mL. A 30-mg vial is supplied as lyophilized powder. Each vial should be reconstituted with 1 mL of Sterile Water for Injection (WFI).
16227382|NCT01182532|Drug|TCM Syndrome Differentiation and Treatment|"Lung-Spleen Damp-Heat Syndrome Symptoms: Fever, maculopapule and herpes on hand, foot and buttock; herpes on oral mucous membrane; redness in throat, salivation, tiredness, faint red tongue or reddish tongue, greasy fur, speedy pulse, red and purple fingerprint.
~Formula: Forsythia suspensa (Thunb.) vahl.(Lian Qiao), Lonicera japonica Thunb (Jin Yin Hua), Scutellaria baicalensis Georgi (Huang Qin), etc.
~Dosage: Adjusting by age and weight of patients. Decoction.
~Dampness-Heat Retention Syndrome Symptoms: High fever, dirty color of tetter, tiredness, oral ulcer, reddish tongue or deep red tongue, little saliva, yellow and greasy fur, fine and rapid pulse, deep purple fingerprint.
~Formula: Forsythia suspensa (Thunb.) vahl.(Lian Qiao), Gardenia jasminoides Ellis (rough Zhi Zi), Scutellaria baicalensis Georgi (Huang Qin), etc.
~Dosage: Adjusting by age and weight of patients. Decoction."
16227383|NCT01182532|Other|Western therapy plus TCM treatment|"Symptomatic treatment using the same treatment methods in western therapy group;
~Syndrome differentiation and treatment adopting the same methods in TCM treatment group."
16227384|NCT01182519|Behavioral|questionnaire, blood draw and urine sample|Patients will be asked to participate on a single day. After study registration they will be asked to complete the questionnaire. All participants will complete a questionnaire detailing tobacco and NSAID exposure, as well as detailing any other inflammatory conditions of the lung. Then the patient will give a single blood sample (up to 3 tubes) and a single urine sample.
16227385|NCT01182506|Behavioral|Cogmed Working Memory Training Program|"Women will be randomized to one of two 5-week rehabilitation software training programs that train working memory called Cogmed Working Memory Training Program.
~The training software will be provided to each participant. For each group, training occurs for 30 minutes a day, 5 days a week for 5 weeks. As part of the set-up, training data is uploaded to the internet at a minimum of every 3 days. This function allows the coach (in this case, the PI and RSA) to review the training. A weekly coach phone call is made to review the training results, answer questions, troubleshoot, and motivate the participant. Participants can load the software onto multiple computers to provide flexibility for them to do training at home, after work, when they are away from home."
16227386|NCT01182493|Device|Insulin Pump (Medtronic Minimed Paradigm® VEO)|The pump delivers insulin as specified by the patient
16227387|NCT01182480|Behavioral|Patient Relationship Management (PRM) Program|"Patients will be contacted through SMS text messaging under the following circumstances:
~7 days, 2 days, and 1 day before scheduled appointments. Messages will contain the date, time, and location where the appointment is scheduled. Patients will be prompted to respond with 'YES' if they are able to keep their appointment, and 'NO' if they need to reschedule. An acknowledgement of receipt will be sent in response to all patient-initiated messages.
~3 days per week to request that patients respond with fasting blood sugar measurements. An acknowledgement of receipt will be sent in response to all patient-initiated messages."
16227388|NCT01182467|Radiation|PET-CT scan|PET-CT scan performed at baseline to determine SUV-max
16227389|NCT01182441|Device|WATCHMAN Device|WATCHMAN Left Atrial Appendage Closure Technology
16227390|NCT01182441|Drug|Warfarin|Warfarin dosage prescribed by study physician to adequately maintain an INR of 2.0-3.0
16227391|NCT01182428|Device|XIENCE V®/ XIENCE PRIME™|Coronary artery placement of a XIENCE V®/ XIENCE PRIME™ Everolimus Eluting Stent System
16227392|NCT01182428|Device|CYPHER SELECT|XIENCE V® / XIENCE PRIME™ to CYPHER SELECT in female patients with de novo coronary artery lesions
16227393|NCT01182415|Procedure|Autologous stem cell transplant|Autologous stem cell transplant following high-dose chemotherapy
16227394|NCT01182415|Drug|High-dose chemotherapy|High-dose chemotherapy with rituximab, thiotepa, busulfan, and cyclosphosphamide
16227395|NCT01182402|Device|Compliance monitoring with electronic device|Patients get all their unsupervised substitution medication doses in electronic monitoring devices during the study. Daily dose of the drug is possible to get from the device in given time points and in the meantime device is locked.
16227396|NCT01182389|Procedure|Robotic VT Ablation|Robotic VT Ablation
16227397|NCT01182389|Other|Conventional Therapy|Review of ICD programming to ensure that detection and therapy will occur appropriately
16227398|NCT01182376|Drug|dronedarone|Dronedarone will be prescribed by the patient's team according to established guidelines.
16227399|NCT01182376|Drug|Placebo|Placebo will be administered by the patient's team according to established guidelines.
16227400|NCT01182363|Behavioral|Project Solve Education|Problem solving education (PSE), a brief skills-building psychotherapeutic intervention that focuses on specific daily problems, and applies to these problems a structured approach to finding and evaluating solutions, is one such problem solving approach. Problem solving education differs from other problem solving interventions in that it can be conducted by a variety of health providers, who do not have specific training as mental health clinicians. Sessions are fairly brief (approximately 30 minutes in length) and positive, sustained effects have been achieved in 6-8 sessions. Problem solving education's success is based on premise that strong problem solving abilities promote a sense of control and self-efficacy and buffer the negative effects of life stressors.
16227401|NCT01182350|Drug|Bevacizumab|
16227402|NCT01182350|Drug|Erlotinib|
16227403|NCT01182350|Drug|Temozolomide|•
16227404|NCT01182350|Radiation|Radiation|
16227405|NCT01182337|Drug|Intradiscal rhGDF-5|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. In vitro experiments have shown that rhGDF-5 can stimulate gene expression and synthesis of the extracellular matrix proteins type II collagen and aggrecan. In vivo experiments in rabbit models of disc degeneration have shown that intradiscal injections of rhGDF-5 can stimulate an increase in disc height and hydration.
16227406|NCT01182337|Drug|Vehicle control|Excipients in Intradiscal rhGDF-5, to include Trehalose, Glycine, HCl, and Water for Injection
16227407|NCT01182285|Drug|Valproic Acid|"Week 1:
~(Days 1-3): Valproic acid - 500 mg every evening (Day 4-7): Valproic acid - 500 mg twice daily (morning and evening) Weeks 2 through 10: Valproic acid 500 mg every morning and 1000 mg every evening"
16227408|NCT01182285|Drug|Liothyronine Sodium|Patients who exhibit an increased radioiodine uptake on Thyrogen scan post valproic acid therapy at week 10. Begin Cytomel for 4 weeks (25 micrograms twice a day)
16227409|NCT01182272|Drug|sorafenib tosylate|
16227413|NCT01182246|Drug|AXP107-11|"The drug substance, AXP107-11, is a crystalline form of genistein, a substance shown in literature data to target pancreatic tumor cells and also the tumor microenvironment and thus sensitizes tumors to chemotherapy. AXP107-11 is formulated in a capsule containing 2x100 mg of active substance.
~A maximum of four cohorts of three to six patients each will be treated with escalating dose levels of AXP107-11 alone (two weeks) and in combination with gemcitabine (one week).
~AXP107-11 capsules will be ingested orally twice daily (morning and evening) each day of the treatment period. In phase Ib, AXP107-11 will be administered once daily on the first treatment day (morning), followed by twice daily administrations continuously throughout the treatment period. When a minimum of six patients have been treated and evaluated on the maintenance dose (phase 1b), additional patients will be included directly into phase IIa."
16227414|NCT01182233|Radiation|Total Skeletal Irradiation|Escalating doses of TSI starting at 200cGy (escalating up to 400cGy unless maximum tolerated dose is determined in lower dose level) in cohort 1 over 5 days followed by high dose melphalan and cytoprotection followed by autologous hematopoietic stem cell transplant
16227415|NCT01182207|Drug|Drospirenone/Ethinyl Estradiol (Gianvi®)|3 mg/0.02 mg Tablets
16227416|NCT01182207|Drug|YAZ®|3 mg/0.02 mg Tablets
16227417|NCT01182194|Drug|Drospirenone/Ethinyl Estradiol (Gianvi®)|3 mg/0.02 mg Tablets
16227418|NCT01182194|Drug|YAZ®|3 mg/0.02 mg Tablets
16227419|NCT01182181|Drug|Anastrozole (Teva Pharmaceuticals USA)|1 mg Tablets
16227420|NCT01182181|Drug|Anastrozole (Arimidex®)|1 mg Tablets
16227421|NCT01182168|Drug|gemcitabine and split-dose cisplatin plus escalating doses of continuous Everolimus (RAD001)|Patients will receive gemcitabine IV and cisplatin IV on days 1 and 8. Everolimus orally will be administered continuously (one cycle = 21 days). Everolimus will be escalated at the following dose levels: 5mg every-other-day, 5mg daily, and 10mg daily. Patients will receive a total of 6 cycles of gemcitabine and cisplatin in combination with Everolimus unless disease progression or unacceptable toxicity occurs.
16227422|NCT01182155|Procedure|Exhaled Breath Sampling|Standard of care
16227423|NCT01182142|Drug|Capecitabine|1,250 mg/m2 orally twice a day, days 1-14
16227424|NCT01182129|Drug|Nicotine|Nicotine pouch, 2.2 mg, single dose, 30 minutes
16227425|NCT01182129|Drug|Nicotine|Chewing Gum, 4 mg, single dose, 30 minutes
16227426|NCT01182116|Procedure|J Pouch|Comparing J pouch, side to end coloanal surgery
16227427|NCT01182090|Procedure|Colposacropexy|In open approach the anterior vaginal wall is dissected from the bladder to expose a vaginal wall area of at least 3 x 5 cms where the mesh will be attached with four-five Polyglycolic 0 sutures. The procedure is repeated for the posterior vaginal wall, where the mesh will be attached with three-four Polyglycolic 0 sutures. The sacral promontory surface is prepared and 1 or 2 non-reabsorbable 0.0 sutures are placed into the sacral periosteum about 2 cm below the promontory. A sub-peritoneal tunnel is created through which meshes are passed avoiding traction to the sacrum. The peritoneum is closed over the meshes.
16227428|NCT01182090|Procedure|Colposacropexy|In laparoscopic approach the anterior vaginal wall is dissected from the bladder to expose a vaginal wall area of at least 3 x 5 cms where the mesh will be attached with four-five Polyglycolic 0 sutures. The procedure is repeated for the posterior vaginal wall, where the mesh will be attached with three-four Polyglycolic 0 sutures. The sacral promontory surface is prepared and 1 or 2 non-reabsorbable 0.0 sutures are placed into the sacral periosteum about 2 cm below the promontory. A sub-peritoneal tunnel is created through which meshes are passed avoiding traction to the sacrum. The peritoneum is closed over the meshes.
16227429|NCT01182077|Drug|ASP015K|Oral
16227430|NCT01182077|Drug|Midazolam|Oral
16227431|NCT01182051|Behavioral|CBT or relaxation training|8 weeks of CBT or relaxation training.
16227432|NCT01182038|Device|BirthRite birthing seat|Randomization takes place on admission to the labor ward when the participants are in active labor.Participants in this arm were to sit on the seat for 20 minute periods.After these 20 minutes, the participant should stand and mobilize during two to three contractions, before resuming the birth seat position. If progress of the descent of the fetal head was obvious the participant was not asked to mobilize.
16227433|NCT01182025|Other|Western therapy|"Symptomatic treatment: vitamin B, vitamin C, mouth care and skin care.
~Adopting physical cooling therapy, including physical cooling paste or warm bathing, when patient's body temperature is lower than 38.5 degree Celsius;
~Using Ibuprofen suspension when patient's temperature higher than 38.5 degree Celsius;"
16227434|NCT01182025|Drug|Xiyanping Injection|"Dosage for child medication:
~5-10mg/kg/d (0.2-0.4ml/kg/d) in 5% Glucose solution, IV, with speed of 20-30 drops per minute, each day; or as directed by doctor."
16227435|NCT01182025|Drug|Xiyanping Injection with western medicine|"Symptomatic treatment using the same treatment methods in western therapy group;
~Symptomatic treatment using the same treatment methods in Xiyanpin injection group."
16227436|NCT01182012|Behavioral|Lifestyle counseling|Depending on the results of cardiovascular risk factor indexes, the treatment (including drugs, if needed) may be modified or adjusted. A nurse visit will be programmed to explain the lifestyle behaviour the patient should have.
16227437|NCT01181999|Drug|rituximab|A dose of 375mg/m2 rituximab will be administered intravenously on day 1 of first to fourth R-CHOP chemotherapy and on day 1, 8, 15, 22 of each augmentation chemotherapy.
16227438|NCT01181986|Drug|Exenatide SC|Exenatide 5-10 ug sc BID/10 days
16227439|NCT01181986|Drug|Exenatide IV|50 ng/min intravenously for 45 minutes on 2 out of 3 study visits separated by 5-10 days
16227440|NCT01181986|Drug|Placebo SC|Placebo sc BID/10days
16227441|NCT01181986|Drug|Exendin-9|Primed (6,000 pM/kg), continuous (600 pM/kg) intravenous infusion for 75 minutes on 1 out of 3 study visits.
16227442|NCT01181986|Drug|Placebo IV|Intravenous infusion for 45 minutes on 1 out of 3 visits
16227443|NCT01181973|Drug|pegvisomant|One 1-mL subcutaneous injection at 30 mg/mL. A 30-mg vial is supplied as lyophilized powder. Each vial should be reconstituted with 1 mL of Sterile Water for Injection (WFI).
16227444|NCT01181973|Drug|pegvisomant|Two 1-mL subcutaneous injections at 15 mg/mL each. Two 15-mg vials are supplied as lyophilized powder. Each vial should be reconstituted with 1 mL of Sterile Water for Injection (WFI).
16227445|NCT01181973|Drug|pegvisomant|Two 1-mL subcutaneous injections at 15 mg/mL each. Two 15-mg vials are supplied as lyophilized powder. Each vial should be reconstituted with 1 mL of Sterile Water for Injection (WFI).
16227667|NCT01180426|Drug|CHR-2797|120mg once daily oral for 48 weeks
16227447|NCT01181960|Drug|Risperidone long acting injectable - New Starts|Patients who switch to Risperidone long acting injectable or receive an initial injection of Risperidone long acting injectable within the 30 days prior to enrollment will be eligible for inclusion in the Risperidone long acting injectable New Starts cohort.
16227448|NCT01181960|Drug|Risperidone long acting injectable - Continuous Users|Patients who have been on Risperidone long acting injectable for at least 6 months before baseline, with no gaps between injections of more than 30 days will be eligible for inclusion in the Risperidone long acting injectable Continuous Users cohort.
16227449|NCT01181960|Drug|Paliperidone Palmitate -New and Continuous Users|Patients newly initiating Paliperidone Palmitate or on Paliperidone Palmitate at the time of enrollment
16227450|NCT01181960|Drug|Other Antipsychotics - New Starts|Participants in the other antipsychotic cohort may be newly started on any oral or injectable antipsychotic other than Risperidone long acting injectable and Paliperidone Palmitate
16227451|NCT01181947|Device|TEVAR|Thoracic endovascular aneurysm repair
16227452|NCT01181934|Other|A643 (nicotine)|2mg oromucosal nicotine spray- three times daily during each treatment period
16227453|NCT01181934|Drug|placebo|placebo - three times daily during each treatment period
16227454|NCT01181934|Other|A643 (nicotine)|1mg oromucosal nicotine spray- three times daily during each treatment period
16227455|NCT01181921|Drug|Galantamine|Type= range, unit= mg, number= 8-24, form= capsule, route= oral use. The starting dose will be 8 mg/day for 4 weeks. Subsequently, the initial maintenance dose will be 16 mg/day for 4 weeks. Then, an increase to the maintenance dose of 24 mg/day should be considered on an individual basis after appropriate assessment.
16227456|NCT01181908|Drug|single dose|Subjects will receive a single dose of GSK1144814 or placebo.
16227457|NCT01181895|Drug|Vilanterol|Vilanterol inhalation powder inhaled orally once daily for 12 weeks
16227458|NCT01181895|Drug|Salmeterol Inhalation Powder|Salmeterol inhalation powder inhaled orally twice daily for 12 weeks
16227459|NCT01181895|Drug|Placebo Inhalation Powder NDPI|Placebo inhalation powder inhaled orally via Novel Dry Powder Inhaler
16227460|NCT01181895|Drug|Placebo Inhalation Powder Diskus|Placebo inhalation powder inhaled orally twice daily for 12 weeks
16227461|NCT01181882|Dietary Supplement|Fish Oil and Aspirin|4 grams of fish oil each day for 28 days and 81 mg aspirin
16227462|NCT01181869|Device|oxygen|oxygen therapy, ventilation for respiratory failure CPAP for sleep apnoea
16227463|NCT01181856|Biological|MVA 85A|Single injection of 1 x 108 pfu MVA85A
16227464|NCT01181830|Drug|magnesium pidolate|administration of 8.1 mmol bid of magnesium pidolate
16227465|NCT01181830|Drug|placebo|administration of 8.1 mmol bid of placebo
16227466|NCT01181817|Other|fMRI and MRS|fMRI and MRS
16227467|NCT01181804|Drug|boceprevir|Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.
16227468|NCT01181804|Drug|boceprevir|Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.
16227469|NCT01181804|Drug|boceprevir|Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.
16227470|NCT01181804|Drug|boceprevir|Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.
16227471|NCT01181791|Dietary Supplement|Lactobacillus reuteri|Lactobacillus reuteri DSM will be given at a dose of 1x108 colony forming units (CFU)/day
16227472|NCT01181791|Other|Placebo|The placebo consists of an identical formulation except that the L. reuteri is not present.
16227473|NCT01181765|Biological|Infliximab 5 mg/kg body weight infused over 2 hours|Subjects will receive IV Infusion of infliximab 5 mg/kg body weight at Week 0, Week 2, Week 6, Week 14 and Week 22 as per the approved Canadian product monograph of infliximab.
16227474|NCT01181726|Drug|Estradiol/Norethindrone acetate|1 mg/0.5 mg Tablets
16227475|NCT01181726|Drug|Activella®|1 mg/0.5 mg Tablets
16227476|NCT01181700|Drug|Treatment A|PF-00241939 300 ug using inhaler A
16227477|NCT01181700|Drug|Treatment B|PF-00241939 300 ug using inhaler A
16227478|NCT01181700|Drug|Treatment C|PF-00241939 300 ug using inhaler A
16227479|NCT01181700|Drug|Treatment D|PF-00241939 300 ug using inhaler B
16227480|NCT01181700|Drug|Treatment E|PF-00241939 300 ug using inhaler B
16227481|NCT01181700|Drug|Treatment F|PF-00241939 300 ug using inhaler B
16227482|NCT01181700|Drug|Treatment G|PF-00241939 300 ug using inhaler B
16227483|NCT01181674|Drug|insulin glargine|sc injection
16227484|NCT01181674|Drug|metformin|oral administration
16227485|NCT01181674|Drug|acarbose|oral administration
16227486|NCT01181674|Behavioral|lifestyle therapy|diet and exercise
16227487|NCT01181674|Drug|insulin glargine|sc injection
16227488|NCT01181674|Drug|metformin|oral administration
16227489|NCT01181674|Drug|acarbose|oral administration
16227490|NCT01181674|Behavioral|lifestyle therapy|diet and exercise
16227491|NCT01181674|Other|Standard glycemic care|as informed by the current clinical practice guidelines
16227492|NCT01181661|Behavioral|Full Group Contingency|This group (n = 20) will earn vouchers based only on team (n = 4) performance. Only if all members of the team submit a negative sample (CO ≤ 4 ppm), will they each earn a voucher.
16227493|NCT01181661|Behavioral|Mixed Group Contingency|This group (n = 20) will earn vouchers based on both individual and team (n = 4) performance. If an individual submits a negative sample (CO ≤ 4 ppm), s/he will earn a voucher. Additionally, bonus vouchers will be earned if all team members submit negative samples.
16227494|NCT01181648|Behavioral|questionnaire and semi-structured interviews|Survivors will be asked to complete a brief, self-administered, paper-based survey to assess quality of life, mental health and employment status following completion of therapy. Second, in a subset of 20 survivors of HPV+ oropharynx cancer, we will conduct in-depth, semi-structured, face-to-face interviews addressing the psychosocial impact of the HPV diagnosis. A follow up letter will be sent to participants who do not return their completed study questionnaires.
16227495|NCT01181635|Behavioral|Psychotherapy|Standard psychotherapy for psychiatric disorders.
16227496|NCT01181622|Drug|denufosol tetrasodium Inhalation Solution|60 mg by oral inhalation three times daily
16227497|NCT01181622|Drug|0.9% w/v sodium chloride solution|0.9% w/v sodium chloride solution by oral inhalation three times daily
16227499|NCT01181583|Behavioral|Tailored Internet-delivered CBT|"This intervention contains 8-10 text-based self-help modules in which 4 modules are fixed (the first three and the last) and the rest are prescribed following the diagnostic telephone interview. These modules contain material on panic disorder, social phobia, stress management, assertiveness training, concentration, relaxation among other things."
16227500|NCT01181583|Behavioral|Non-tailored Internet-delivered CBT|Specific text-based self-help for depression, which has previously been tested in three previous randomized trials. Anxiety symptoms will not be covered, but insomnia is included as a module together with advice on health.
16227501|NCT01181583|Behavioral|Online discussion group|Participants take part of an online discussion group which are monitored daily. New discussion topics on depression are introduced every week.
16227502|NCT01181570|Drug|Adalimumab|Patients receive adalimumab 80 mg followed by 40 mg at week 1 and 40 mg every other week (EOW) thereafter.
16227503|NCT01181570|Drug|Placebo|Patients will receive 2 injections of placebo at week 0, one injection at week 1 and one injection every other week (EOW) thereafter.
16227504|NCT01181544|Procedure|Heparin dose titration|Patients will begin the study using their currently prescribed heparin doses - both bolus and constant infusion - for three treatments to establish a baseline and provide information on inter-treatment variability in dialyzer clotting. Subsequently, the bolus and infusion rates will be titrated either upward or downward based on the Robbins-Monro process and an evaluation of dialyzer clotting during the preceding treatment. Heparin doses will be adjusted for a total of 30 dialyses.
16227505|NCT01181531|Drug|Traditional Vitamin D Therapy|Traditional vitamin D therapy (eg, calcitriol, paricalcitol, alfacalcidol, doxercalciferol), to manage secondary hyperparathyroidism (SHPT) in this study will be administered according to strategies that have been used in clinical practice and that conform to current therapeutic recommendations and available clinical practice guidelines and product labeling.
16227506|NCT01181531|Drug|Cinacalcet|Subjects randomized to treatment with cinacalcet will receive an initial oral dose of 30 mg once daily. Doses will be titrated incrementally to 60, 90,120, and 180 mg per day based upon periodic measurements of serum calcium and plasma PTH levels. Cinacalcet is formulated as light green tablets in 30, 60, and 90 mg free-based equivalents. Tablets will be 30, 60, and 90 mg, graduated in size, smallest to largest. Combinations of these 3 fixed dosage formulations will be used to achieve the 120 and 180 mg daily doses.
16227507|NCT01181505|Drug|Tolterodine|
16227508|NCT01181479|Drug|AG200-15 (cycles 1-13)|AG200-15 containing ethinyl estradiol and levonorgestrel
16227509|NCT01181479|Drug|Lessina crossover to AG200-15|Low dose oral contraceptive containing 20 mcg ethinyl estradiol and 100 mcg Levonorgestrel in 21 day regimen for 6 cycles followed by AG200-15 for 6 cycles.
16227510|NCT01181466|Device|AeriSeal System|The AeriSeal System will be Administered at 3 to 4 Pulmonary Subsegments During a Single Treatment session.
16227511|NCT01181453|Device|Dermagraft|Weekly application of Dermagraft(R) with standard care
16227512|NCT01181453|Other|Comparator|Weekly application of standard care
16227513|NCT01181440|Device|Dermagraft(R)|Weekly application of Dermagraft(R) with conventional care
16227514|NCT01181440|Other|Conventional care|Weekly application of conventional care
16227515|NCT01181427|Drug|ABT-267|See arm description
16227516|NCT01181427|Drug|Placebo|See arms description
16227517|NCT01181427|Procedure|Blood Sample Collection|See arm description
16227518|NCT01181427|Drug|Cytochrome P450 inhibitor|See arm description
16227519|NCT01181414|Procedure|Atrio ventricular junction ablation with radio-frequency|Atrioventricular junction ablation by using radiofrequency energy.
16227520|NCT01181414|Drug|Beta blocker/digoxine/amiodarone|Ventricular rate control by using drug treatment.
16227521|NCT01181401|Drug|TPF induction chemotherapy|Docetaxel 75 mg/m2 d 1 Cis-platinum 75 mg/m2 d 1 5-FU 750 mg/m2/d c.i. d 1-4 Cetuximab loading dose of 400 mg/m2 1 week prior to RTX, and 250 mg/m2 weekly x 6 concurrent to RTX
16227522|NCT01181401|Drug|TPF experimental|Docetaxel 40 mg/m2 d 1+8 Cis-platinum 40 mg/m2 d 1+8 5-FU 1500 mg/m2/24h c.i. d 1+8 every 21 day for 3 cycles 2. Antibody therapy with: cetuximab loading dose of 400 mg/m2 1 week prior to RTX, and 250 mg/m2 weekly x 6 concurrent to RTX
16227523|NCT01181401|Radiation|Standard Radiochemotherapy (HART)|Hyperfractionated accelerated radiotherapy with concurrent Cisplatin and 5-Fluorouracil chemotherapy
16227524|NCT01181388|Procedure|administration of tirofiban by thrombus aspiration catheter in infarct-related artery|a bolus of 10ug/kg tirofiban administration via thrombus aspiration catheter followed by 0.1ug/kg/min for 12 hours after PCI
16227525|NCT01181388|Procedure|administration of tirofiban by guide catheter|a bolus of 10ug/kg tirofiban administration via guide catheter followed by 0.1ug/kg/min for 12 hours after PCI
16227526|NCT01181375|Other|Tumour Biopsies and Blood Sampling|Patients who consent to the tissue part of this study will have Biopsies taken for study purposes at the same time as their routine tumour biopsies . In addition,those who consent to the blood sampling part of the study will have their samples taken assess serum biomarkers of tumour oxygenation.
16227527|NCT01181362|Procedure|Endoscopy|All patients will meet the physician at the Head and Neck centre at PMH, where they will have a topical anesthetic (lidocaine endotracheal aerosol, 10 mg/dose) sprayed into both nostrils. After allowing 5-10 minutes to let the anesthetic take effect, they will have an endoscopy procedure using a flexible scope inserted through the nostrils. The procedure will first be performed while patients are sitting up. During the procedure, patients will be asked to rate their discomfort on a 10-point scale. The endoscope will then be removed. After a short rest (15 minutes), the endoscopy procedure will be repeated with patients lying down. They will again be asked to rate their level of discomfort. After another short rest for recovery, they will meet with the physician to discuss both endoscopic procedures and to complete a questionnaire on discomfort, tolerance and acceptability
16227528|NCT01181349|Other|Neuromuscular Blocking Agent (NMBA)|While neuromuscular blockade drug(s) are involved in this study prior to actual study initiation (this is an observational study), it should be noted that the identity, combination(s), and dosages of these drugs (also referred to as general anesthesia drug[s]) are not specified in the protocol.
16227529|NCT01181349|Other|Neuromuscular Blocking Agent (NMBA)|While neuromuscular blockade drug(s) are involved in this study prior to actual study initiation (this is an observational study), it should be noted that the identity, combination(s), and dosages of these drugs (also referred to as general anesthesia drug[s]) are not specified in the protocol.
16227530|NCT01181336|Biological|Influenza vaccine (FLU-v)|Comparison of different dosages of FLU-v (sterile lyophilised mixture of polypeptide T-cell epitope sequences). Administration: A single subcutaneous injection of (Low Dose / High Dose with adjuvant / water for injection)
16227531|NCT01181336|Biological|FLU-v Control|Adjuvant only or water for injection only Administration: a single subcutaneous injection
16227532|NCT01181323|Other|Placebo|0.2 ml of Intranasal placebo study product (using sucrose phosphate placebo filled sprayers), will be administered to maternal subjects.
16227533|NCT01181323|Biological|Cold-adapted live attenuated influenza virus vaccine, trivalent|Licensed product formulated for the 2011-2012 or 2012-2013 influenza season. Standard dose LAIV (Flumist®) 0.1 ml administered to maternal subjects intranasally in each nostril for a total of 0.2 mL.
16227534|NCT01181323|Other|Placebo|0.5 ml of Sterile saline (0.9 percent Sodium Chloride for injection), administered IM to maternal subjects.
16227535|NCT01181323|Biological|Trivalent inactivated influenza vaccine|Preservative free, licensed product formulated for the 2011-2012 or 2012-2013 influenza season. Standard dose of TIV (Fluzone®) 0.5 ml administered to maternal subjects, IM in the deltoid.
16227536|NCT01181310|Drug|A: Placebo to match Donepezil and MK-3134 + Placebo to match Scopolamine|Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of placebo to match scopolamine SQ.
16227537|NCT01181310|Drug|B: Placebo to match Donepezil and MK-3134 + Scopolamine 0.5 mg|Single doses of placebo to match both donepezil and MK-3134 PO, plus a single dose of scopolamine 0.5 mg SQ.
16227538|NCT01181310|Drug|C: MK-3134 25 mg + Scopolamine 0.5 mg|A single dose of MK-3134 PO 25 mg, plus a single dose of scopolamine SQ 0.5 mg.
16227539|NCT01181310|Drug|D: Donepezil 10 mg + Scopolamine 0.5 mg|A single dose of donepezil 10 mg PO, plus a single dose of scopolamine 0.5 mg SQ.
16227540|NCT01181310|Drug|E: Combo: Donepezil 10 mg + MK-3134 25 mg + Scopolamine 0.5 mg|A combination of single doses of all active drugs: donepezil 10 mg and MK-3134 25 mg PO, plus scopolamine, SQ.
16227541|NCT01181297|Other|Extensively Hydrolyzed Formula with a Probiotic|
16227542|NCT01181297|Other|Extensively Hydrolyzed Formula without a Probiotic|
16227543|NCT01181271|Drug|Busulfan (conditioning for AUTO transplant)|0.8 mg/kg intravenous (IV) bolus every six hours (Q6H) on days -8,-7,-6,-5 (total of 14 doses). The total daily dose of busulfan will be 3.2 mg/kg on days -8,-7, and -6 and 1.6 mg/kg on day -5
16227544|NCT01181271|Drug|Etoposide (conditioning for AUTO transplant)|Etoposide 30 mg/kg IV bolus every day (QD) on day -4. The total daily dose of etoposide will be 30 mg/kg.
16227545|NCT01181271|Drug|Cyclophosphamide (conditioning for AUTO transplant)|Cyclophosphamide 60 mg/kg IV bolus QD on days -3 and -2. The total daily dose of cyclophosphamide will be 60 mg/kg.
16227546|NCT01181271|Drug|Mesna (prior to AUTO transplant)|Mesna 15 mg/kg IV bolus on days -3 and -2 infused over 15 minutes and given 15 minutes prior to cyclophosphamide administration. This is followed by Mesna given 15 mg/kg IV bolus three times daily (TID) on days -3 and -2 infused over 15 minutes at 3, 6, and 9 hours after completion of cyclophosphamide infusion. Total daily dose of Mesna should be equivalent to daily dose of cyclophosphamide. Lastly, Mesna will be given at 15 mg/kg IV bolus QD on day -1. This makes a total of 9 doses of Mesna
16227547|NCT01181271|Other|autologous (auto) peripheral blood stem cell transplantation|Infusion of autologous peripheral blood stem cells on Day 0.
16227548|NCT01181271|Drug|Neupogen|Neupogen 5 mcg/kg subcutaneous (SQ) daily starting on day +1 until absolute neutrophil count (ANC) is greater than or equal to 1000 per micro liter on two separate occasions or greater than 5000 per micro liter once
16227549|NCT01181271|Drug|Fludarabine (conditioning for ALLO Transplant)|Fludarabine 30 mg/m2/day will be administered as a bolus infusion over approximately 30 minutes for 4 days on days -5, -4, -3, -2.
16227550|NCT01181271|Drug|Busulfan (conditioning for ALLO Transplant)|Busulfan will be administered by IV infusion over approximately 3 hours on days -5, -4, -3, -2. The dose of busulfan will be 0.8 mg/kg/day
16227551|NCT01181271|Other|non-myeloablative allogeneic (allo) transplant|Donor peripheral blood stem cells (PBSC) will be infused intravenously beginning on Day 0. The minimum total CD34+ cell dose will be 2 x 10^6 CD34+cells/kg of recipient's actual body weight with a maximum dose of 8 x 10^6/kg of recipient's actual body weight
16227552|NCT01181271|Drug|Tacrolimus|Tacrolimus (FK506) will be given orally at a dose of 0.05 mg/kg orally (PO) twice a day (BID) starting day -3.
16227553|NCT01181271|Drug|Sirolimus|Sirolimus (rapamycin) will be given orally at a dose of 12 mg times one on day -3 and then the dose shall be 4 mg by mouth daily starting on day -2. The dose may then be adjusted according to serum levels at the discretion of the treating physician
16227554|NCT01181271|Drug|Methotrexate|Methotrexate will be administered once daily on days 1, 3, and 6 as an IV bolus over 15 minutes at a dose of 5 mg/m2
16227555|NCT01181258|Drug|Rituximab|375 mg/m^2 administered intravenously (IV) weekly * 4, (day -7, -1, +6, +13) pre-infusion with natural killer cells (NK)
16227556|NCT01181258|Biological|Interleukin-2|subcutaneously administered 9 million international units (IU) every other day * 6 doses over 2 weeks begin 1 to 24 hours after NK cell infusion. If weight < 45 kilograms, give IL-2 at 5 million units/m2 on same schedule.
16227557|NCT01181258|Biological|Natural killer cells|administered intravenously 1.5 to 8 * 10^7 cells/kg on Day 0 (day of NK cell infusion)
16227558|NCT01181258|Drug|Cyclophosphamide|60 mg/kg administered intravenously (IV) for 2 hours on day -5 after Fludarabine.
16227559|NCT01181258|Drug|Methylprednisolone|1 mg/kg on Days -2 through +9 as an intravenous (IV) infusion.
16227560|NCT01181258|Drug|Fludarabine|25 mg/m^2/day administered as a 1 hour IV infusion once a day for 5 doses (day -6 through day -2).
16227561|NCT01181245|Drug|FG-3019|3mg/kg IV, 10mg/kg IV, 15mg/kg IV, 25mg/kg, 35mg/kg IV, 45mg/kg IV - Biweekly, 35/17.5mg/kg, 45/22.5 mg/kg - Weekly
16227562|NCT01181232|Drug|Zolpidem MR|oral
16227563|NCT01181232|Drug|Zolpidem IR|oral
16227564|NCT01181219|Procedure|CXL without epithelial removal|UV-radiation of a Riboflavin saturated cornea without prior epithelial removal
16227565|NCT01181219|Procedure|CXL with epithelial removal|UV-radiation of a Riboflavin saturated cornea after surgical epithelial removal has been performed
16227566|NCT01181206|Procedure|Intervention Arm 1: Covering with approved abdominal 3M™ Steri-Drape™ Wound Edge Protector Intervention Arm 2: Covering with standard woven swabs|
16227567|NCT01181193|Other|Surgery|Craniotomy with total or partial removal of the brain tumor
16227568|NCT01181193|Radiation|Radiotherapy to tumour bed and/or residual tumour|60 Gy in 30 fractions over 6 weeks
16227569|NCT01181193|Drug|Temozolomide|"75 mg/m2/day for entire period of radiotherapy
~150-200 mg/m2/day for 5 days every 28 days, 6 cycles total"
16227570|NCT01181193|Drug|Vitamin D3|4000 IU started 1 week before commencing radiotherapy and discontinued immediately after completing last chemotherapy cycle
16227571|NCT01181180|Dietary Supplement|water consumption|The effect of water consumption on postural stability of old adults (65 years old and over) will be measured using RCT study design
16227572|NCT01181167|Drug|edoxaban|
16227573|NCT01181167|Drug|enoxaparin sodium|
16227574|NCT01181154|Drug|rituximab (Mabthera®)|1000 mg at day 1 and day 15
16227575|NCT01181154|Drug|Placebo|equivalent volume total
16227576|NCT01181141|Drug|DU-176b (edoxaban)|
16227577|NCT01181141|Drug|Enoxaparin sodium 20mg|
16227578|NCT01181128|Drug|Factor VIII (rFVIIIFc)|
16227579|NCT01181128|Drug|Advate®|
16227580|NCT01181115|Drug|Avonex|Interferon treatment for MS
16227581|NCT01181102|Drug|edoxaban|
16227582|NCT01181102|Drug|enoxaparin sodium|
16227583|NCT01181089|Biological|Placebo|
16227584|NCT01181089|Biological|Baminercept|
16227585|NCT01181076|Dietary Supplement|Individualized Nutrition|The patients who are able to achieve oral nutrition requirement will receive a therapeutic diet using regular foods, which is lactose-reduced and energy-enriched. The naso-jejunal tube will be inserted during the first five days after transplantation. EN will be given when oral intake discontinue. EN with an additional PN will be given if the estimated requirements by the enteral route is lower than reference values.
16227586|NCT01181063|Drug|Budesonide/formoterol 320/9 μg and 400/12 μg inhalers|Budesonide/formoterol 320/9 μg and 400/12 μg in different kind of inhalers and Symbicort Turbuhaler forte 320/9 μg. Ech subject will be randomly allocation to 4 of 5 products, a single dose administration of each product
16227587|NCT01181050|Drug|NNC0142-0002|A single dose of 4 mg NNC 0142-0000-0002/kg bodyweight. Administered subcutaneously (s.c., under the skin).
16227588|NCT01181050|Drug|placebo|A single dose of 4 mg NNC 0142-0000-0002 placebo/kg bodyweight. Administered subcutaneously (s.c., under the skin).
16227589|NCT01181024|Drug|Placebo|matching RO5303253 placebo, administered as single dose (Parts A + B) or multiple dose (Part C)
16227590|NCT01181024|Drug|RO5303253|Cohorts receiving single ascending doses
16227591|NCT01181024|Drug|RO5303253|Single dose
16227592|NCT01181024|Drug|RO5303253|Multiple doses
16227593|NCT01181011|Drug|amlodipine/telmisartan/combination|patient would take amlodipine(5mg)/telmisartan(80mg)/combination(T80+A5mg) single dose in random order, and each dosage will be separated in 21 days interval.
16227594|NCT01180998|Device|Senofilcon A Toric (AOfA)|Soft toric contact lenses for astigmatism
16227595|NCT01180998|Device|Etafilcon A Toric (1DAMfA)|Soft toric contact lenses for astigmatism
16227596|NCT01180985|Device|galyfilcon A prototype lens|silicone hydrogel contact lens
16227597|NCT01180985|Device|comfilcon A|silicone hydrogel contact lens
16227598|NCT01180959|Drug|Bevacizumab|10 mg/kg by vein once every 2 weeks on days 1 and 15 of each cycle. The first dose of bevacizumab will be given over about 90 minutes
16227599|NCT01180959|Drug|Erlotinib|150 mg by mouth once a day.
16227600|NCT01180946|Dietary Supplement|ergocalciferol|ergocalciferol (a dietary form of vitamin D). 50,000 units by mouth once a week for 16 weeks.
16227601|NCT01180946|Other|placebo pill|placebo pill once weekly for 16 weeks. At the end of the study, subjects in this arm will receive vitamin D repletion
16227602|NCT01180933|Dietary Supplement|fish oil|400 mg of DHA and 150 mg of eicosapentaenoic acid per day
16227603|NCT01180933|Dietary Supplement|folate|400 µg per day
16227604|NCT01180933|Dietary Supplement|fish oil + folate|500 mg DHA, 150 mg eicosapentaenoic acid, 400 µg MTHF per day
16227605|NCT01180933|Dietary Supplement|placebo|only vitamins and minerals as recommended, but no fish oil or folate
16227606|NCT01180894|Drug|Iron sucrose|100 mg IV TIW
16227607|NCT01180894|Drug|Placebo|
16227608|NCT01180855|Drug|Placebo|Placebo pill nightly for 42 nights.
16227609|NCT01180855|Drug|Rozerem 8mg|Rozerem 8mg pill, nightly for 42 nights
16227610|NCT01180855|Other|Rozerem 8mg in combination with Multi Component Behavior Therapy|Rozerem 8mg pill nightly for 42 nights with 4 sessions and 2 telephone calls of Multi Component Behavior Therapy.
16227611|NCT01180842|Other|Yoga treatment program|yoga program designed specifically for the patient with CF
16227612|NCT01180829|Behavioral|Personalized feedback text messages|A series of 12 text messages, each of which contains one personalized feedback item about the person's drinking.
16227613|NCT01180829|Behavioral|Consciousness raising text messages|A series of 12 text messages, each of which consists of an item designed to get the person to think about his or her drinking
16227614|NCT01180816|Drug|Super-Selective Intraarterial Intracranial Infusion of Temozolomide|A single dose of Intraarterial Mannitol to open the blood brain barrier followed by Intra-arterial Temozolomide single dose (starting at 75mg/m2 and up to 250mg/m2)
16227615|NCT01180803|Device|pulse oxygen supplementation devices|oxygen therapy delivered by systems using oxygen-saving valves
16227616|NCT01180803|Device|continuous oxygen|oxygen therapy delivered by continuous liquid oxygen devices
16227617|NCT01180790|Drug|ACH-0141625 (Sovaprevir)|200 mg oral capsule once daily
16227618|NCT01180790|Drug|ACH-0141625 (Sovaprevir)|400 mg oral capsule once daily
16227619|NCT01180790|Drug|ACH-0141625 (Sovaprevir)|800 mg oral capsule once daily
16227620|NCT01180790|Drug|Placebo|Powder in capsule once daily
16227621|NCT01180790|Drug|Pegylated Interferon alpha-2a|180 ug once a week by subcutaneous injection
16227622|NCT01180790|Drug|Ribavirin|400 mg or 600 mg (am) and 600 mg (pm) capsules taken orally twice daily
16227623|NCT01180777|Device|etafilcon A (A)|Daily wear contact lens
16227624|NCT01180777|Device|etafilcon A (B)|Daily wear contact lens
16227625|NCT01180777|Device|etafilcon A (C)|Daily wear contact lens
16227626|NCT01180764|Drug|Lovaza (Omega-3 acid ethyl esters)|1g capsules, 4 capsules po daily
16227627|NCT01180764|Drug|Placebo|Placebo matching active lovaza, 1 g capsules, 4 capsules po daily
16227628|NCT01180751|Radiation|[18F]-Fluorodeoxyglucose|With each Positron Emission Tomography/Computed Tomography (PET/CT)scan an intravenous administration of radioactive glucose (FDG)is given. This is a weight dependent dosage.
16227629|NCT01180738|Behavioral|Body weight supported treadmill training|Training will include 10 sessions over a 2 week period, each session with 30 minutes of walking on a treadmill using a body weight support system.
16227630|NCT01180738|Behavioral|Overground walking training|Training will include 10 sessions over a 2 week period, each session with 30 minutes of walking overground.
16227631|NCT01180725|Dietary Supplement|Dried Plum|
16227632|NCT01180725|Dietary Supplement|Metamucil|
16227633|NCT01180712|Dietary Supplement|Mirtoselect|"Male subjects (BMI > 30) with type 2 diabetes controlling their diabetes by diet alone or impaired glucose tolerance.
~Volunteers will be given either a total daily dose of 1.4 grams of concentrated blaeberry extract (mirtoselect provided by Indena S.p.A. (http://www.mirtoselect.info/) in a hard gelatin capsules or control capsules containing lactose administered thrice a day for 21 days."
16227634|NCT01180699|Biological|Influenza vaccine: Vaxigrip or Fluviral and Intanza|Patients will be randomized to receive either one intradermal dose of 0.1 mL or one intramuscular injection of 0.5 mL of the standard influenza vaccine in the deltoid muscle of the nondominant arm.
16227635|NCT01180686|Device|Activator IV single impulse instrument|This is a manually operated device that delivers a single thrust into the joint involved.
16227636|NCT01180686|Device|Multiple thrust Impulse adjusting instrument|A device used for delivering 12 thrusts to the involved joint of the lumbar spine.
16227637|NCT01180673|Behavioral|MINT-TLC|This intervention is based on established clinical practice guidelines for prevention and treatment of hypertension, which recommend weight loss (if overweight), limiting sodium and alcohol intake, regular physical activity, and eating a low-fat diet that is rich in fruit and vegetables. Seniors will attend weekly group classes conducted by trained research assistants for the first 12 weeks (intensive phase); followed by three individual motivational interview (MINT) sessions that will occur monthly over the next three months (extended phase); and finally each senior will receive three bi-monthly booster MINT sessions in the remaining six months (maintenance phase).
16227638|NCT01180673|Behavioral|Control Condition|"Seniors randomized to the control arm will receive a single individual brief advice session on therapeutic lifestyle changes recommended for blood pressure reduction. In addition, they will be given print versions of the NHLBI publications Your Guide to Lowering Blood Pressure; and Facts about the DASH Eating Plan. Sessions will be delivered by trained research assistants."
16227639|NCT01180660|Drug|Lidocaine Infusion|1.5 mg/kg bolus followed by an infusion of 2 mg/kg/hr throughout the intra operative period
16227640|NCT01180660|Drug|Normal Saline|Saline bolus equal to that of lidocaine in addition to continuous infusion of normal saline during the intra operative period
16227641|NCT01180647|Drug|Extended-Release Naltrexone|380mg IM XR-NTX injection one week prior to release from jail; a second XR-NTX 380mg IM injection is offered 4 weeks later (monthly).
16227642|NCT01180647|Behavioral|Motivational Enhancement Counseling|The randomized control arm receives no medication treatment and is offered brief, two-session Motivational Enhancement counseling prior to release from jail.
16227643|NCT01180634|Drug|MP-376 (Levofloxacin solution for Inhalation)|240 mg of MP-376 administered BID for 28 days
16227644|NCT01180634|Drug|Placebo|same volume and frequency as study drug
16227645|NCT01180621|Biological|Fluviral|0.25 mL Fluviral for children up to and including 35 months of age 0.50 mL Fluviral for children 36-59 months of age
16227646|NCT01180608|Other|MR Spectroscopy|"During each MR Spectroscopy session, we will measure at regions of interest (rACC, both thalami, dominant DLPC) the levels of the following biochemical substances:
~gamma-aminobutyric acid (GABA)
~glutamate (Glu)
~glutamine (Gln)
~N-acetylaspartate (NAA)
~Choline-containing compounds (Cho)
~Creatine plus phophocreatine (total creatine: Cr)
~Myo-inositiol (Ins)
~Choline (Cho)
~Glucose (Glc)
~Lactate (Lac)"
16227647|NCT01180595|Device|Trabecular Metal Modular Tibial Total Knee Component|The modular design of the Trabecular Metal Total Knee allows for increased options for physicians however, it is not clear how this modular feature will affect fixation since it may compromise some of the advantages of the original TM Monoblock tibial component.
16227648|NCT01180595|Device|Trabecular Metal Monoblock Tibial Total Knee Component|
16227649|NCT01180582|Device|Triathlon Periapatite (PA)-coated Tibial Component|Triathlon Periapatite (PA)-coated Total Knee Arthroplasty Tibial Component for uncemented fixation
16227650|NCT01180569|Drug|lenalidomide|"Patient enrollment FNA of palpable lymph node prior to escalation phase
~Escalation phase of Lenalidomide:
~Lenalidomide 5 mg daily PO x 14 days Lenalidomide 10 mg daily PO x 14 days Lenalidomide 15 mg daily PO x 14 days Week of rest FNA of palpable lymph node prior to treatment phase
~Treatment phase of Lenalidomide:
~15 mg daily PO days 1-21 out of a 28 day cycle Repeat x 6 cycles"
16227651|NCT01180556|Dietary Supplement|Probiotics|Daily oral supplementation for four weeks
16227652|NCT01180556|Dietary Supplement|Placebo|Placebo administration
16227653|NCT01180543|Device|Oplon Active Patch|Patches are placed over acne lesion overnight. Treatment is a single treatment.
16227654|NCT01180543|Device|Placebo Patch|same as active patch
16227655|NCT01180530|Device|NovoPen Echo®|Prescribed insulin treatment delivered by NovoPen Echo®
16227656|NCT01180517|Procedure|Percutaneous coronary intervention (PCI)|balloon angioplasty
16227657|NCT01180517|Procedure|PCI|balloon angioplasty
16227658|NCT01180504|Radiation|intensity-modulated whole-abdominal radiotherapy|Consolidation intensity-modulated whole-abdominal radiotherapy using helical tomotherapy to a total dose of 30 Gy in 1.5 Gy fractions
16227659|NCT01180491|Device|K101 nail solution|
16227660|NCT01180478|Device|White Light|White Light Cystoscopy
16227661|NCT01180478|Device|Narrow Band Imaging|Narrow Band Imaging
16227662|NCT01180465|Drug|LIPO-102|LIPO-102 High dose
16227663|NCT01180465|Drug|LIPO-102 Low|LIPO-102 Low dose
16227664|NCT01180465|Drug|LIPO-102, Placebo|Placebo
16227665|NCT01180452|Procedure|enteroscopy|endoscopic enteroscopy to do biopsies on jejunum
16227666|NCT01180439|Device|Adjustment of ventilator settings (device)|Decrease in pressure support, increase in respiratory back-up rate, increase in expiratory positive airway pressure (EPAP) to counteract effect of PEEPi, and adjustment of cycling (at higher percentage of peak inspiratory flow)
16227668|NCT01180413|Drug|Amlodipine|5 mg per day for 6 months as add-on to original ongoing antihypertensive treatment
16227669|NCT01180413|Drug|Ramipril|5 mg per day for the first to weeks as add-on to original ongoing antihypertensive treatment. Then upward adjustment to 10 mg per day for 6 months if no intolerable side effects are experienced.
16227670|NCT01180413|Drug|Lercanidipine|Up to 20 mg per day for 6 months as add-on to original ongoing antihypertensive treatment
16227671|NCT01180413|Drug|Losartan|Up to 100 mg per day for 6 months as add-on to original ongoing antihypertensive treatment
16227672|NCT01180400|Drug|TC-5214|Tablet, oral, twice daily for 8 weeks
16227673|NCT01180400|Drug|Placebo|Tablet, oral, twice daily for 8 weeks
16227674|NCT01180374|Drug|Cannabidiol|Active Cannabidiol 5mg.
16227675|NCT01180374|Drug|Delta-9-THC|"Active Delta-9-THC (0.035mg/Kg) given intravenously over 20 minutes. The dose of THC that you may receive is a small dose and is roughly equivalent to smoking approximately one half to one whole marijuana cigarette, or joint."
16227676|NCT01180374|Drug|Placebo|Placebo (about a quarter spoon of alcohol with no CBD).
16227677|NCT01180374|Drug|Placebo|Placebo (about a quarter spoon of alcohol with no THC) given intravenously over 20 minutes.
16227678|NCT01180348|Drug|Botulift|Application of 90 U of Botulift divided in 3 applications on each side of the face in fifteen predetermined sites in three regions of the face (front, glabellar, periocular).
16227679|NCT01180348|Drug|Botox|Application of 90 U of Botox divided in 3 applications on each side of the face in fifteen predetermined sites in three regions of the face (front, glabellar, periocular).
16227680|NCT01180335|Drug|Chemotherapy|4 cycles FEC followed by 4 cycles docetaxel
16227681|NCT01180335|Drug|Genomic driven chemotherapy|High DLD30 receive 3 months weekly paclitaxel followed by 4 FEC, patients with high TOP2A receive 4FEC then 4 docetaxel, patients with low DLD30 and low TOP2A are treated with 6 cycles of docetaxel-capecitabine.
16227682|NCT01180322|Drug|Cytarabine|"Induction therapy:100 mg/m2/day by continuous intravenous (IV) infusion on days 1-7 (total dose 700 mg/m2)
~Consolidation therapy:
~Younger adults (18 to 65 years): 3 g/m2/day by IV infusion over 3 hours every 12 hours on days 1, 2, and 3 (total dose 18 g/m2).
~Elderly patients (>65 years): 1 g/m2/day by IV infusion over 3 hours every 12 hours on days 1, 2, and 3 (total dose 6 g/m2)."
16227683|NCT01180322|Drug|Idarubicin|"First induction therapy:
~Arm A, C, D:
~12 mg/m2/day by IV push on days 1,3,5 (total dose 36 mg/m2). For elderly (>65 yrs) patients only two doses of idarubicin are foreseen on days 1+3.
~Arm B:
~12 mg/m2/day by IV push on days 6, 8 10 (total dose 36 mg/m2). For elderly (>65 yrs) patients only two doses of idarubicin are foreseen on days 6+8.
~Second induction therapy:
~Arm A, C, D:
~12 mg/m2/day by IV push on days 1 and 3 (total dose 24 mg/m2; for all age groups)
~Arm B:
~12 mg/m2/day by IV push on days 6 and 8 (total dose 24 mg/m2; for all age groups)."
16227684|NCT01180322|Drug|Etoposide|"Induction therapy:
~Arm A, C, D:
~100 mg/m²/day by 1-hour IV infusion on days 1,2,3 (total dose 300 mg/m2). On days 1 and 3 start after idarubicin push. For elderly (>65 yrs) patients only two doses of etoposide are foreseen on days 1+3.
~Arm B:
~100 mg/m²/day by 1-hour IV infusion on days 6,7,8 (total dose 300 mg/m2). On days 6 and 8 start after idarubicin push. For elderly (>65 yrs) patients only two doses of etoposide are foreseen on days 6+8."
16227685|NCT01180322|Drug|Azacitidine|"Induction therapy:
~Arm B and C:
~100 mg/m2/day by subcutaneous (SC) injection or 15-minute IV infusion on day 1 to day 5 (total dose 500 mg/m2). Azacitidine is always given prior to idarubicin and etoposide.
~Arm D:
~100 mg/m2/day by SC injection or 15-minute IV infusion on days 4-8 (total dose 500 mg/m2). Azacitidine is always given prior to idarubicin and etoposide.
~Maintenance therapy:
~Arm B, C, D:
~50 mg/m2/day by SC injection on days 1-5 (total dose 250 mg/m2) every 4 weeks. (Maintenance therapy is scheduled for a total duration of 2 years in patients with continuous CR)"
16227686|NCT01180322|Drug|Lenograstim|"Consolidation therapy:
~subcutaneously daily beginning on day 10 until neutrophil count > 0.5 x 109/l."
16227687|NCT01180296|Drug|oral micronized progesterone|oral micronized progesterone = 400 mg oral micronized progesterone nightly from 16 to 34 weeks
16227688|NCT01180296|Drug|Identical Placebo tablet|Identical Placebo tablet = placebo taking nightly from 16 to 34 weeks
16227689|NCT01180283|Drug|lodenafil carbonate|Dosage: lodenafil carbonate 80mg once a day. It should be taken between 6 and 2 hours before the sexual intercounter.
16227690|NCT01180244|Device|Noninvasive cortical electrical stimulation|Subjects will receive 22 sessions of the intervention protocol, twice per week for a total of 11 weeks. The signal stimulation used in this study utilizes amplitude modulation to shape a high frequency carrier signal, nominally greater than 10 kilohertz, into the form of one or more low frequency components, nominally less than 40 hertz. Exact protocol is set in software and is the same for all participants in the active treatment arm.
16227691|NCT01180244|Device|Sham treatment|Subjects in the placebo group will receive the exact same experience as those in the active treatment group. However, the device will not output any electrical stimulation signal.
16227692|NCT01180231|Drug|Moxonidine (Physiotens)|Subjects will be asked to take moxonidine, dosage to be determined prior to commencement by a medical doctor for 6 months duration.
16227693|NCT01180231|Other|Dietary intervention|Subjects will be asked to follow dietary plans designed by a qualified nutritionist for 6 months.
16227694|NCT01180218|Procedure|complete revascularization|-Complete revascularization : one time primary percutaneous coronary intervention (PCI) of the culprit and nonculprit lesions in patient with ST elevateion myocardial infarction (STEMI) and multivessle disease
16227695|NCT01180218|Procedure|Culprit revasularization|Culprit revascularization : PCI of only the culprit lesion and staged nonculprit PCI at a later date in patients with ST-segment elevation myocardial infarction (STEMI) and multivessel disease.
16227696|NCT01180205|Drug|Telmisartan|Telmisartan (80 mg ,Tablets, QD, p.o., 26 weeks)
16227697|NCT01180205|Drug|Amlodipine|Amlodpine 5 mg po 14 days, the forced - titration to 10 mg po for 24 weeks
16227698|NCT01180205|Drug|Olmesartan medoxomil|Olmesartan 40 mg po for 26 weeks
16227699|NCT01180205|Drug|Hydrochlorothiazide|HCT 12,5 mg po for 14 days, then 25 mg po for 24 weeks
16227700|NCT01180192|Drug|oxygen|either 8 L/minute O2 via face mask for 2 hours
16227701|NCT01180179|Drug|Lansoprazole|30mg once daily
16227702|NCT01180179|Drug|Famotidine|40mg once daily
16227703|NCT01180166|Drug|nimotuzumab|200 milligram (mg) of nimotuzumab per week during radiation period
16227704|NCT01180153|Drug|S-1 oxaliplatin|S-1 (20mg, 25mg); L-OHP (50 mg)
16227705|NCT01180140|Device|Seamguard|GORE SEAMGUARD® Bioabsorbable Staple Line Reinforcement is specifically engineered to reduce the incidence of perioperative leaks and bleeding in a variety of open and minimally invasive surgeries. Then, after six months, it is completely absorbed eliminating the risk of a prolonged inflammatory response.
16227706|NCT01180127|Dietary Supplement|Flavanol containing food product|12 weeks, 2X/day, 20g serving
16227707|NCT01180127|Behavioral|Aerobic training|4X/week, 1 hour/session at 75% maximum HR
16227708|NCT01180127|Dietary Supplement|Food product lacking flavanol|20 g serving, 2X/day, food additive lacking flavonol
16227709|NCT01180127|Behavioral|Wait list control|12 week wait list control condition during which participants abstain from aerobic exercise
16227710|NCT01180114|Behavioral|Suubi-Maka ('Hope for Families')|Each child in the SUUBI-MAKA condition receive the usual care plus asset focused services, specifically: a matched Child Development Account (CDA); twelve 1-2 hour training sessions on career planning, setting short-term and long-term career goals, and how to save money; and monthly mentorship program with young adult peers (undergraduate students) on life options and how to avoid risk behaviors. In addition, participants receive a 2:1 match for their deposits into the account. Further, participants and their adult caregivers receive specific training on microenterprise development and specifically on how to start an income-generating project using up to 50% of the matched savings. The intervention is delivered over a period of 24 months.
16227711|NCT01180114|Other|Usual Care|Each child in the control condition receives the usual services for orphaned children (counseling, school lunches, and textbooks).
16227712|NCT01180101|Behavioral|Diet and exercise|This group will follow a hypocaloric diet and supervised exercise training for 12 weeks.
16227713|NCT01180101|Procedure|Bariatric Surgery|Patients will undergo bariatric surgery
16227714|NCT01180088|Procedure|RIGHT HEPATECTOMY WITH CLASSIC APPROACH|The right portal branch and the right branch of the hepatic artery were identified, dissected and divided. Extraparenchymal ligation of pedicles for Sg4 was performed in case of extended right hepatectomy. The falciform and the right triangular ligaments were sectioned and the right liver up to the retrohepatic vena cava was totally mobilized by section and sutures of the accessory right hepatic veins. The right hepatic vein was controlled in an extrahepatic plane and encircled with a tape. At the end of parenchymal transection right hepatic vein was sectioned with endovascular stapler. The right bile duct and middle hepatic vein (in case of extended right hepatectomy) were divided intraparenchymally
16227715|NCT01180075|Drug|tenofovir/emtricitabine/efavirenz (TDF/FTC/EFV)|Patients receiving this drug for clinical care at standard dosages will be enrolled.
16227716|NCT01180075|Drug|tenofovir/emtricitabine (TDF/FTC)|Patients receiving this drug for clinical care at standard dosages will be enrolled.
16227717|NCT01180075|Drug|Atazanavir (ATV)|Patients receiving this drug for clinical care at 300mg with 100mg ritonavir daily will be enrolled.
16227718|NCT01180075|Drug|Ritonavir|Patients receiving this drug for clinical care at 100mg daily with 300mg atazanavir will be enrolled.
16227719|NCT01180075|Procedure|Phlebotomy|Multiple blood draws will be performed in the study, and vary depending on the group.
16227720|NCT01180062|Drug|Latanoprost|"Group 1 will be given a single, low dose Latanoprost SR insert that contains a daily dose of 0.5µg Latanoprost.
~Group 2 will be given two, low dose Latanoprost SR inserts that contain a combined daily dose of 1.0µg Latanoprost.
~Duration of drug release is expected to be 3-6 months.
~Group 3 will be given a single, low dose Latanoprost SR insert that contains a daily dose of 2.0µg Latanoprost."
16227721|NCT01180062|Drug|Arm 2|Group 2 will be given two, low dose Latanoprost SR inserts that contain a combined daily dose of 1.0µg Latanoprost.
16227722|NCT01180062|Drug|Latanoprost SR insert|Group 3 will be given a single, low dose Latanoprost SR insert that contains a daily dose of 2.0µg Latanoprost.
16227723|NCT01180049|Drug|temsirolimus|175mg IV once a week for first 3 weeks, followed by 75mg IV once a week until disease progression, provided that patient is tolerating treatment and getting clinical benefit
16227724|NCT01180049|Drug|temsirolimus|75mg IV once a week until until disease progression, provided that patient is tolerating treatment and getting clinical benefit
16227725|NCT01180036|Drug|Rituximab|1000 mg, I.V. on Days 1 and 15 and will be retreated at month 6 independent of cluster of differentiation (CD) 19+ B cell count
16227726|NCT01180036|Drug|Cyclosporine|Patients randomized to the Cyclosporine arm will be started at a dose of (CsA = 3.5 mg/kg/day p.o. divided into 2 doses for 12 months). Target trough CsA blood levels, as determined in whole blood by High Performance Liquid Chromatography (HPLC), are 125 to 175 ng/ml. A persistent and otherwise unexplained increase in serum creatinine >30% would prompt an approximate 25% dose reduction of CSA, aiming for a corresponding 25% reduction in CSA trough level. If with this dose reduction the creatinine does not return to within 30% of baseline levels within 3 weeks, then a second dose reduction of approximately 25% with similar reduction in CSA trough level will be used. If the creatinine does not fall to baseline values with this second dose reduction, the drug will be discontinued. At the end of 12 months, Cyclosporine will be tapered by 1/3 of the maintenance dose monthly and hence discontinued after 3 months.
16227727|NCT01180023|Procedure|Sweeping|Sweeping of membranes during digital exam
16227728|NCT01180010|Procedure|Low Dose CT|"A chest CT uses special radiographic equipment using x-rays to capture images of the chest, and with the aid of a computer, processes the images to create cross-sectional pictures or slices of the areas of interest. The images can then be printed out or examined on a monitor. The CT scanner is a large unit with a hole running directly through its center, giving the appearance of a doughnut. During the scanning, patients will lie flat on their back on a table, and they are periodically asked to hold their breath. The table will first move through the scanner to determine the correct starting position. The rest of the scans are made as the table moves more slowly through the cavity in the scanner."
16227729|NCT01179997|Device|Interventricular pacing delay optimization by using Tissue Doppler-derived displacement curves|
16227730|NCT01179997|Device|Electrocardiographic optimization of the interventricular pacing delay according to QRS width|
16227731|NCT01179984|Device|Bard® LifeStent® Vascular Stent System|Stent Implantation
16227732|NCT01179971|Dietary Supplement|Fish oil, gamma-linolenic acid|3 g/d DHA + EPA
16227733|NCT01179958|Behavioral|aerobic training|24 weeks of aerobic training, 4X/week
16227734|NCT01179958|Behavioral|stretching/toning|stretches and toning exercises designed to promote flexibility and improved core strength
16227735|NCT01179945|Other|benzoate containing test drinks|"Subjects will consume 500ml of water with 0.5 grams of sodium benzoate, followed by a solution of 75g sugar in 500ml water with 0.5 grams sodium benzoate 3 hours later.
~Each solution will be consumed over 5 minutes."
16227736|NCT01179945|Other|non sodium benzoate containing test drinks|"Subjects will consume 500ml of water followed by a solution of 75g sugar in 500ml water 3 hours later.
~Each solution will be consumed over 5 minutes."
16227737|NCT01179932|Other|No Intervention Used|Our study is observational; therefore, there is no type of intervention being used.
16227738|NCT01179919|Drug|Oseltamivir|Capsule, 75 mg by mouth for 9 doses
16227739|NCT01179906|Behavioral|Exercise training|Subjects exercise trained for 48 weeks with personal trainers at a college wellness center
16227740|NCT01179906|Behavioral|Diet modification|Exercise training using personal trainers 3 times per week. Individuals were trained at a moderate intensity
16227741|NCT01179893|Biological|IVIG|Intravenous immunoglobulin
16227742|NCT01179893|Procedure|PLEX|Plasma exchange: removal of pathogenic antibodies and constituents and replacement with albumin.
16227743|NCT01179880|Drug|E6005|Four Steps of Ointment Application: Step 1: 0.01% of E6005; Step 2: 0.03% of E6005; Step 3: 0.1% of E6005; Step 4: 0.2% of E6005.
16227744|NCT01179880|Drug|Placebo|Matching placebo for each step
16227745|NCT01179867|Other|Electronic Medication Reconciliation|"At admission the community drug list will be electronically retrieved from the public drug insurance administrative databases using a real-time interface, and the admitting team/pharmacist will verify the list, adding over-the-counter medications
~At discharge the attending physician/resident will write the discharge prescription using the discharge reconciliation module, allowing the physician to simultaneously view the validated community drug list and the hospital pharmacy drug list for the patient
~The discharge communication module will facilitate identification and transfer of information on discontinued and changed medication to the respective dispensing pharmacies and prescribing physicians along with the reasons for these changes"
16227746|NCT01179854|Drug|Remegal|Drug/ placebo
16227747|NCT01179841|Behavioral|Playgroup|The playgroup will be conducted at our center and focuses on providing an invigorating learning environment in which emerging skills/knowledge are skillfully brought to a higher level of maturity, integrated with existing abilities, and used functionally. Learning with and through peers, provides the opportunity to address abnormal peer relationships for developmental level. Providing an enriched environment with toys, structured learning, and opportunities for ongoing engagement we offer the children experiences that they would not otherwise have. Parent training sessions will focus on strategies aimed at improving child social engagement and communication. Parent education sessions will focus on topics related to autism, learning styles, interventions, and resources.
16227748|NCT01179841|Behavioral|Parent Training|The 1-2 hour individual therapeutic sessions with parent training in the home or clinic (1x every week over six months) are based on our own program which is in development. This program focuses on teaching parents how to encourage social and communication skills in their toddlers and also provides comprehensive information about development. Sessions will focus on knowledge of autism, current access to services, general knowledge of strategies used to facilitate child development, advocacy, knowledge of how to access services, and coping strategies.
16227749|NCT01179841|Behavioral|Parent Training|In the once-a-week 1 to 2 hour parent training/enrichment, we will ask parents to target specific play and care routines in which they may stimulate their child's development in the ways identified by the therapist. These stimulation times may be provided by the parents, other family members, friends, volunteers or hired assistants. Parents will be encouraged to have their child in direct skill-enhancing engagement for 1-2 hour per day. The therapist will work with the family to identify times during the day that best lend themselves to accomplishing this goal.
16227750|NCT01179828|Drug|Oxycodone 15mg|15mg single administration p.o.
16227751|NCT01179828|Drug|Clobazam|20mg single administration p.o.
16227752|NCT01179828|Drug|Imipramine|75mg single administration p.o.
16227753|NCT01179828|Drug|Tolterodine|1 mg single administration p.o.
16227754|NCT01179802|Other|Strenuous Endurance exercise|"Jungfraumarathon: Mountain-Marathon with a length of 42km and a altitude-difference of approximately 1830meters."
16227755|NCT01179789|Behavioral|Optimal Diet|a dietician will train each subject (or the caregiver) to use the personalized diet on web platform
16227756|NCT01179789|Dietary Supplement|VSL#3®|probiotic blend Product should be administrated orally, 2 capsules b.i.d. on an empty stomach (at least 30 min. before lunch and dinner) with a glass of water
16227757|NCT01179789|Dietary Supplement|AISA-5203-L|fruit extracted terpene Product should be administrated orally, the dosage depending from the body weight of the subject enrolled in the study as already stated : 1-2 pills three times a day with a meal and a large glass of water
16227758|NCT01179789|Dietary Supplement|Argan oil|Product should be administrated orally, 25 ml once daily or during the day with a meal (bread, salad …) and a large glass of water
16227759|NCT01179776|Drug|Ilomedin|Ilomedin
16227760|NCT01179776|Drug|Placebo|i.v saline
16227761|NCT01179776|Drug|Ilomedin|
16227762|NCT01179776|Drug|Ilomedin and standard low dose treatment|
16227763|NCT01179763|Other|Optical coherence tomography|Spectral domain optical coherence tomography will be conducted once when patients are enrolled.
16227764|NCT01179750|Device|Ultrasonic Coagulating Shears|comparison of operated groups between with Ultrasonic Coagulating Shears and without them.
16227765|NCT01179737|Drug|Nilotinib|Nilotinib capsules for oral administration at 50 mg, 150 mg twice a day and 300 mg (2 capsules of 150 mg) twice a day.
16227766|NCT01179737|Drug|Placebo to nilotinib|Placebo to nilotinib capsules for oral administration to match 50 mg, 150 mg and 300 mg capsules twice a day
16227767|NCT01179724|Drug|high dose proton pump inhibitor|IV loading PPI before 2hr to conduct ESD, and IV 8mg/h continuous infusion within 48hr, and then 40mg oral pantoprazole for one month
16227768|NCT01179724|Drug|H2RB|IV 50mg loading H2 receptor antagonist before 2hr to conduct ESD, and IV 13mg/h continuous infusion within 48hr, and then 300mg oral H2 receptor antagonist for one month
16227769|NCT01179711|Device|Glasses prescription|At initial visit(of study), the physician will reduce the diopter of hyperopic glasses as much as the patient can maintain their eye alignment (maximum amount 1.5D).
16227825|NCT01179282|Biological|dust mite extract or placebo|intervention will be to stop study drug or placebo
16227770|NCT01179698|Procedure|Navigation surgery|In en bloc resection, the osteotomy sites were determined by navigation guidance. For curettage, we monitored curette in real-time with navigation.
16227771|NCT01179698|Procedure|Navigation system|In en bloc resection, the osteotomy sites were determined by navigation guidance. For curettage, we monitored curette in real-time with navigation.
16227772|NCT01179685|Procedure|pleural fluid tapping|Minimally invasive technique to detect malignant pleural effusion
16227773|NCT01179672|Drug|Duloxetine|30 mg administered orally (po), QD for 1 week; 60 mg administered po, QD for remaining 11 weeks; 30 mg administered po, QD for 1 week during taper period
16227774|NCT01179672|Drug|Placebo|Administered po, QD for 12 weeks; administered po, QD for 1 week during taper period
16227775|NCT01179659|Drug|Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet|Single dose crossover BE study
16227776|NCT01179646|Drug|Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet|Single dose crossover BE study
16227777|NCT01179633|Device|OPLON active patch|
16227778|NCT01179633|Device|Sham patch|
16227779|NCT01179620|Drug|Certoparin|Certoparin
16227780|NCT01179607|Drug|M0002|
16227781|NCT01179607|Drug|Placebo|
16227782|NCT01179594|Drug|entecavir|0.5 mg orally daily, 24 weeks (weeks 12-36)
16227783|NCT01179594|Drug|peginterferon alfa-2a [Pegasys]|180 mcg sc weekly, 48 weeks
16227784|NCT01179594|Drug|peginterferon alfa-2a [Pegasys]|180 mcg sc weekly, 96 weeks
16227785|NCT01179594|Drug|placebo|orally daily, 24 weeks (weeks 12-36)
16227786|NCT01179581|Drug|GLPG0634|single ascending doses, oral solution (1 to 10 mg/dose) and capsules (10 to 200 mg/dose)
16227787|NCT01179581|Drug|placebo|single dose, oral solution or capsule (matching corresponding study medication)
16227788|NCT01179581|Drug|GLPG0634|multiple dose, capsule, 10 days
16227789|NCT01179581|Drug|placebo|multiple dose, capsule, 10 days
16227790|NCT01179568|Drug|Citalopram|16 weeks of medication provided flexibly up to 40 mg/day. Medication will be administered in a double-blind fashion.
16227791|NCT01179568|Behavioral|Complicated Grief Treatment|Complicated Grief Treatment (CGT) is a targeted psychotherapy for complicated grief. The treatment integrates principles, strategies and techniques from interpersonal psychotherapy, trauma-focused cognitive behavioral treatment and motivational interviewing. Treatment includes 16 sessions provided within 20 weeks.
16227792|NCT01179568|Other|Placebo|16 weeks of daily inactive medication. It will be administered in a double-blind fashion.
16227793|NCT01179555|Behavioral|Behavioral Activation|Baseline assessment plus 4 in-home problem solving therapy sessions.
16227794|NCT01179555|Behavioral|Supportive Therapy|Baseline assessment plus 4 in-home sessions of supportive therapy.
16227795|NCT01179529|Drug|Omalizumab (Xolair®)|
16227796|NCT01179516|Drug|Vortioxetine|Encapsulated vortioxetine immediate release tablets
16227797|NCT01179516|Drug|Placebo|Vortioxetine placebo-matching capsules
16227798|NCT01179503|Dietary Supplement|calcium|600 mg calcium carbonate twice daily (total of 1200 mg/day) for 4 months
16227799|NCT01179503|Dietary Supplement|Vitamin D plus calcium|1000 IU of vitamin D3 twice daily (for a total of 2000 IU/day) plus 600 mg calcium carbonate twice daily (for a total of 1200 mg/day)
16227800|NCT01179490|Drug|SyB L-0501|SyB L-0501 (150 mg/m2/day) will be administered by intravenous drip infusion for 60 min for 2 consecutive days and the course will be observed for the next 26 days. This is taken as one cycle and administration is repeated for 2-9 cycles (when a plateau is not reached after nine cycles, administration of up to an additional three cycles for a maximum of 12 cycles is possible).
16227801|NCT01179490|Drug|prednisolone|Prednisolone will be administered (60 mg/m2/day) orally for 4 consecutive days and the course will be observed for the next 24 days.
16227802|NCT01179477|Device|Implantation of a QuickFlex® μ Model 1258T LV Lead|Implantation of a QuickFlex® μ Model 1258T LV Pacing Lead
16227803|NCT01179464|Drug|Aminobiphosphonate|Patients will receive standard intravenous biphosphonate treatment
16227804|NCT01179464|Drug|Simvastatin|40 mg once daily
16227805|NCT01179451|Device|echocardiogram|echocardiogram
16227806|NCT01179438|Drug|Dexmedetomidine|The loading does of 0.5 mcg/kg dexmedetomidine is infused over 10 minutes. The following maintenance does of dexmedetomidine is 0.5 mcg/kg/hour.
16227807|NCT01179425|Other|Cognitive stressor|The Paced Auditory Serial Addition Task (PASAT-C), has been modified for use as a computerized laboratory-based stressor. Single digits are presented, and the patient must add each new digit to the one immediately prior to it and click on the appropriate answer. Failure to do so in the allotted time results in a noxious error sound.
16227808|NCT01179412|Drug|2% povidone-iodine|apply 4 times a day for one week
16227809|NCT01179412|Drug|2% povidone-iodine|apply 2% povidone-iodine 4 times per day for one week
16227810|NCT01179399|Drug|TAK-960|TAK-960 administered orally once a day for 21-days of a 28-day treatment cycle. A 3 + 3 dose escalation scheme will be employed.
16227811|NCT01179373|Device|TMS, H coil|TMS, H Coil, High/ Low Frequency
16227812|NCT01179360|Other|Integrated FDG PET/CT|Optimized PET/CT imaging with dedicated head-and-neck protocol
16227813|NCT01179347|Drug|tiotropium Respimat® inhaler|to evaluate safety and efficacy tiotropium delivered with Respimat® inhaler compared to placebo.
16227814|NCT01179347|Drug|Placebo Respimat® inhaler|patient to receive placebo matching active drug once daily
16227815|NCT01179334|Drug|Riociguat (Adempas, BAY63-2521)|BAY63-2521: 1 mg tid - 2,5 mg tid oral for 12 weeks.
16227816|NCT01179334|Drug|Placebo|Placebo for 12 weeks
16227817|NCT01179334|Drug|Sildenafil|Participants continued to take daily stable sildenafil background treatment according to their prescriptions.
16227818|NCT01179321|Other|Early referral to Dietitian for assessment and nutrition support|
16227819|NCT01179308|Other|General-epidural anesthesia|General anesthesia combined with epidural anesthesia
16227820|NCT01179308|Other|Balanced general anesthesia and postoperative opioids|General anesthesia alone
16227821|NCT01179295|Drug|BAY86-9766|BAY86-9766 30 mg twice a day (bid).
16227822|NCT01179295|Drug|BAY86-9766|BAY86-9766 50 mg twice a day (bid).
16227823|NCT01179295|Drug|BAY86-9766|BAY86-9766 100 mg once a day (od)
16227824|NCT01179295|Drug|BAY86-9766|BAY86-9766 60 mg once a day (od)
16227826|NCT01179269|Drug|Pazopanib plus Paclitaxel|Pazopanib daily and weekly paclitaxel IV
16227827|NCT01179256|Dietary Supplement|CURCUMIN|oral supplementation of curcumin 2000mg
16227828|NCT01179256|Other|no intervention other than stopping study|no intervention other than stopping study
16227829|NCT01179230|Other|SPECT imaging|Dipyridamole stress testing 0.57 mg/kg
16227830|NCT01179230|Other|PET imaging|Dipyridamole stress test 0.57 mg/kg with Rubidium PET images
16227831|NCT01179217|Drug|L-glutamine|0.3 g/kg of L-glutamine will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration. Mixing L-glutamine with soda or highly acidic juices (such as grapefruit juice or lemonade) is not recommended.
16227832|NCT01179217|Drug|Placebo|0.3 g/kg of placebo (100% maltodextrin) will be administered twice a day orally to each patient for 48 weeks. The dosage will be in increments of 5 grams based on weight. The upper limit for daily dose of study medication will be set at 30 grams. Patients will be given verbal and written instructions for self-administration of the study medication at the Baseline visit. The powder can be mixed with water or most non-heated beverages other than alcohol, or can be mixed with most non-heated foods such as yogurt, applesauce, or cereal for administration.
16227833|NCT01179204|Procedure|Preoperative heat stimulation|Preoperative short and long tonic heat stimulation
16227834|NCT01179191|Drug|morphine sulfate and naltrexone hydrochloride (EMBEDA)|Capsules in dose strengths ranging from 20 to 100 mg morphine sulfate with 0.8 to 4 mg of naltrexone hydrochloride taken either once or twice daily with a starting dose calculated using the total daily dose of the current opioid being converted from until a stable dose is achieved or six weeks which ever comes first.
16227835|NCT01179165|Other|Diagnostic|Diagnostic non-invasive tests:Dopplerechocardiography, cardiac MRI
16227836|NCT01179152|Drug|Budesonide turbuhaler, Budesonide+Formoterol turbuhaler|Budesonide 200 mcg turbuhaler or Budesonide+Formoterol 160mcg turbuhaler
16227837|NCT01179139|Other|Biopsy|Percutaneous 2-3 mm biopsies of middle turbinate mucosae and nasal polyps will be obtained with 5 mm Thrucut® (Smith & Nephew, Memphis, TN) biopsy forceps. Generally, 2-3 specimens will be obtained from each side as in previous studies. Healthy controls and subjects with CRS without NP will have biopsies from both middle turbinates. Subjects with CRS with NP will have two nasal polyp biopsies and one middle turbinate biopsy.
16227838|NCT01179126|Procedure|complete multivessel revascularization|After a successful primary PCI these patients will undergo complete revascularization of non-culprit lesions in a staged procedure during the index admission
16227839|NCT01179126|Procedure|stress echocardiography and revascularization if required|after successful primary PCI, this group will undergo a stress echo to evaluate the significance of non-culprit lesions. If large area of ischemia is demonstrated, the artery supplying that are will be revascularized.
16227840|NCT01179113|Drug|Esmolol|Esmolol group: Will receive 0.5 mg/kg IV bolus of esmolol during induction, and an infusion of esmolol at 0.3 mg/kg/hr intraoperatively.
16227841|NCT01179113|Drug|Saline|Loading: an equivalent volume for the Esmolol group Infusion: an equivalent volume for the Esmolol group
16227842|NCT01179100|Drug|Lidocaine|Lidocaine (10mg/ml) Loading: 1.5 mg/kg + Infusion: 0.035 mg/kg/min
16227843|NCT01179074|Procedure|oesophageal stenting with self expandable metal stent|oesophageal stent placement for high grade dysphagia in inoperable oesophageal cancer
16227844|NCT01179074|Procedure|Oesophageal stent followed by external beam radiotherapy|30 Gy in 10 fractions over 2 weeks administered in the stent followed by EBRT group
16227845|NCT01179061|Drug|Apelin|"Cardiac index will be assess in patients through the 6hr infusion, using thoracic cardiac bioimpedance. Prior to starting the infusion there will be a 30 minute run in period to achieve a stable cardiac index. Thereafter the infusion will be started, with cardiac index assess every five minutes during the first hour. For each subsequent hour participants will be free to mobilise for the thirty minute periods, with cardiac index and systemic haemodynmics assess for the following thirty minutes.
~Additionally during the first hour pulmonary artery pressure will be estimated from pulmonary artery pressures assessed with echocardiography. This will be assessed at baseline with four further measurements during the first hour of infusion.
~Participants will be asked to void prior to the study starting, thereafter all urine will be collected during the course of the study. Relevant biochemical/humoral factors will be assessed in the urine."
16227846|NCT01179061|Drug|Placebo|As per apelin arm, however we will use a saline placebo infusion. All other aspects will remain the same.
16227847|NCT01179048|Drug|liraglutide|Maximum dose of 1.8 mg liraglutide, injected subcutaneously (under the skin) once daily. Administered in addition to the subject's standard treatment
16227848|NCT01179048|Drug|placebo|Maximum dose of 1.8 mg placebo, injected subcutaneously (under the skin) once daily. Administered in addition to the subject's standard treatment
16227849|NCT01179035|Other|Transitions Clinic - parolee-targeted care|Subjects receive ongoing primary care from the Transitions Clinic versus ongoing primary care in the San Francisco Department of Public Health affiliated primary care network.
16227850|NCT01179035|Other|Expedited Primary Care|Following randomization, subjects receive ongoing primary care in the San Francisco Department of Public Health affiliated primary care network. Appointments are expedited with safety-net primary care providers.
16227851|NCT01179009|Drug|Ketamine|Controlled IV ketamine infusion (0.00225mg/kg-min. [18% (0.0125 mg/kg-min.). A subset of participants will receive ketamine maintenance injections (0.5-5 mg/kg, IM) for up to 16 weeks after 100-hour infusion.
16227852|NCT01179009|Drug|Clonidine|Participants will receive an approximately 5-day pretreatment of clonidine (max. dose 1mg/day divided doses) prior to and throughout the ketamine infusion.
16227853|NCT01179009|Drug|placebo|IV saline (i.e. placebo ketamine)
16227854|NCT01179009|Drug|Scopolamine Transdermal Product|Some participants will receive a scopolamine transdermal patch prior to and throughout their infusion/injections visits.
16227855|NCT01179009|Drug|lorazepam Injection|A subset of participants will receive lorazepam IM maintenance injections for up to 16 weeks after 100-hour infusion.
16228234|NCT01175941|Drug|Placebo control|Matched placebo - administered as a 2 g suppository, once daily for 7 days
16227856|NCT01178996|Biological|Thymosin alpha 1|Thymosin alpha 1 (Zadaxin) 1.6 mg/day, two times weekly in the morning, by subcutaneous injection for 48 weeks.
16227857|NCT01178996|Drug|Ribavirin|Ribavirin 1000 mg (<75 kg) or 1200 mg (>75 kg) daily with food divided in two doses orally for 48 weeks
16227858|NCT01178996|Biological|PEGinterferon alfa2a|180 mcg, once weekly in the evening, by subcutaneous injection for 48 weeks
16227859|NCT01178996|Drug|Placebo|Placebo
16227860|NCT01178983|Device|surface electromyography|Surface electromyography (SEMG) telebiofeedback
16227861|NCT01178983|Device|surface electromyography|conventional biofeedback
16227862|NCT01178970|Behavioral|Resistance training|
16227863|NCT01178957|Other|Hyperglycemia|Hyperglycemia with a blood glucose of 15 mmol/L
16227864|NCT01178944|Other|Laboratory Biomarker Analysis|Correlative studies
16227865|NCT01178944|Drug|Oxaliplatin|Given IV
16227866|NCT01178944|Drug|Pralatrexate|Given IV
16227867|NCT01178931|Drug|Oral dydrogesterone|oral-2x10mg
16227868|NCT01178931|Drug|Crinone 8% gel|vaginal-1x90mg
16227869|NCT01178905|Procedure|ultrashort heat inactivation|
16227870|NCT01178892|Dietary Supplement|Placebo|Three placebo gel capsules filled with vegetable oil are taken daily for a total of approximately 2 grams of vegetable oil. Each gel capsule also contains 15 IU of vitamin E, natural lemon flavoring, rosemary extract, and a small amount of non-omega-3 fish oil.
16227871|NCT01178892|Dietary Supplement|Omega-3|The study supplement, omega-3-fish oils, is taken as 3 gel capsules daily that together contain approximately 2 grams of fish oil. Each gel capsule (1/3 of the daily dose) has a total omega-3 dosage of 615 mg with two major omega-3 components of ethyl eicosapentaenoic acid (EPA; 425 mg) and docosahexaenoic acid (DHA; 100 mg). Vitamin E (15 IU), an antioxidant, is added to each gel capsule to prevent oxidation and preserve freshness. Each gel capsule also contains natural lemon oil and rosemary extract to enhance taste and freshness.
16227872|NCT01178892|Behavioral|Yoga|Yoga instruction is provided during 12 weekly 90-minute classes, designed for women without prior yoga experience. Each class includes an introductory breathing exercise, 11 to 13 gentle postures followed by deep relaxation with a visualization exercise. Study participants are expected to attend each of the 12 weekly yoga classes plus do daily 20-minute at-home practices. Classes are offered at 2 different times during the week.
16227873|NCT01178892|Behavioral|Exercise|The exercise intervention is facility-based aerobic exercise training on a treadmill, stationary bicycle or elliptical trainer performed 3 times a week for 12 weeks. The duration of each training session is determined for each woman based on the weekly total energy expenditure goal and workload required to achieve her prescribed exercise heart rate. Women train at 50-60% heart rate reserve (HRR) for the first month and then increase intensity to 60-70% HRR. To ensure that women train at their prescribed exercise heart rates, women wear Polar Heart Rate Monitors while exercising. The exercise counselor overseeing each exercise session records each participant's exercise heart rate every 5-10 minutes to document that she is in her target heart rate range.
16227874|NCT01178892|Behavioral|Usual Activity|"Women randomly assigned to the Usual Activity group will be asked to continue with their usual physical activities during the study and not make changes. At completion of the intervention, women will have the opportunity to attend a yoga class and receive the yoga booklet, CD, and DVD for home use; or receive a one-month gym membership."
16227875|NCT01178879|Behavioral|Telehealth consultation|"The consultations are structured as outpatient sessions immediately after discharge. The content of the education deals with the regular treatment, prevention of exacerbation and how to live with the illness. The aim of the counseling is to increase the patient's empowerment and competence to take action. The patients have the consultations for 7 days followed by a telephone call. Each session is organized and individualised according to the patient's wishes and needs for education and counselling.
~The equipment consists of a computer with web camera, microphone and measurement equipment. A button to contact to the nurse at the hospital, an alarm button and a volume button. The results are transferred to the hospital by a secure internet line."
16227876|NCT01178853|Drug|Warfarin|Warfarin 5 mg once daily
16227877|NCT01178853|Drug|Warfarin 5mg + Rosuvastatin 40 mg once daily (QD)|Warfarin 5mg + Rosuvastatin 40 mg once daily (QD)
16227878|NCT01178853|Drug|Warfarin 5 mg + Pitavastatin 4mg once daily (QD)|Warfarin 5 mg + Pitavastatin 4mg
16227879|NCT01178840|Device|WC then FC2|4 uses of WC followed by 4 uses of FC2
16227880|NCT01178840|Device|FC2 then WC|4 uses of WC followed by 4 uses of FC2
16227881|NCT01178827|Drug|trospium chloride|trospium chloride (60mg) once daily for 10 days
16227882|NCT01178827|Drug|oxybutynin IR|oxybutynin IR (5 mg) three times daily for 2 days
16227883|NCT01178827|Drug|oxybutynin IR placebo|oxybutynin IR placebo three times daily for 2 days
16227884|NCT01178814|Drug|Revlimid (Lenalidomide)|The starting dose will be 10 mg days 1-28 with the first dose reduction going to 5 mg days 1-28 of a 28 day cycle. Therapy will cease if there is no response after 12 weeks.
16227885|NCT01178788|Drug|17 alpha-hydroxy progesterone caproate|weekly injection of 17 P
16227886|NCT01178788|Drug|micronized Progesterone|daily administration of vaginal progesterone
16227887|NCT01178788|Procedure|Control|
16227888|NCT01178775|Behavioral|walking|use a pedometer for records steps.
16227889|NCT01178762|Drug|Azithromycin|Oral Azithromycin in the Treatment of Chlamydial Conjunctivitis
16227890|NCT01178736|Procedure|Breast Cancer Screening and Diagnosis|Clinical Breast Examination and Sonography followed by Fine needle aspiration biopsy (FNAB) of screen positive cases.
16227891|NCT01178736|Procedure|Cervical Cancer Screening and Diagnosis|Visual Inspection with Acetic acid, PAP smear or Human Papilloma Virus DNA testing followed by Cryotherapy of screen positive cases.
16227892|NCT01178736|Procedure|Ovarian Cancer Screening and Diagnosis|Transvaginal sonogram and clinical evaluation in post menopausal women with symptoms suggestive of ovarian cancer.
16227893|NCT01178736|Procedure|Endometrial Cancer Screening and Diagnosis|Transvaginal sonographic assessment of the endometrial stripe in post menopausal women with abnormal bleeding.
16227971|NCT01178021|Drug|Chloroquine/Primaquine|Chloroquine 10 mg/kg on day 0 & 1 and 5mg/kg on day 2 Primaquine (if given) 0.25mg/kg/day for 14 days
16228012|NCT01177800|Drug|Infliximab|5 mg/kg infusion given intravenously at Week 0,2,6 (induction treatment phase) and at Week 14 and 22 in maintenance phase in infliximab arm and at Week 12 and 16 in Placebo arm.
16227894|NCT01178723|Dietary Supplement|breakfast size|"The research group will receive instructions to eat a large breakfast, Dividing the total daily calories recommended to the patient to: breakfast - 1/8 of the total daily calories , lunch - 1/3 of the total daily calories and supper- 1/3 of the total daily calories.
~(the rest of the calories will be snacks between the meals) In contrast, the control group that will receive instructions to eat a small breakfast.
~Dividing the total daily calories recommended to the patient to: breakfast - 1/3 of the total daily calories , lunch - 1/4 of the total daily calories and supper- 1/4 of the total daily calories (the rest of the calories will snacks between the meals).
~The instructions will be adapted to each patient individually"
16227895|NCT01178710|Drug|Simvastatin|20 mg per day, start at 5 days before surgery and continue for one year. For some congenital heart diseases which other drugs such as digoxin, antistone, furosemide were prescribed less than half year, simvastatin will be prescribed less than half year.
16227896|NCT01178697|Drug|Bevasizumab|Intravitreal, 1.25 mg, 3 times, one month apart.
16227897|NCT01178697|Drug|Triamcinolone Acetonide|Intravitreal, 2 mg, 2 times, two months apart.
16227898|NCT01178671|Drug|Mirtazapine|Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks
16227899|NCT01178671|Drug|Sertraline|Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks
16227900|NCT01178671|Other|Sugar pill|Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks
16227901|NCT01178658|Drug|Busulfan, etoposide, cytarabine, and melphalan|Busulfan 3.2 mg/kg/d for 2 days, etoposide 400 mg/m2/d for 2 days, cytarabine 1 g/m2 for 2 days, and melphalan 140 mg/m2 for 1 day
16227902|NCT01178645|Drug|Busulfan, etoposide, cytarabine, and melphalan|Busulfan 3.2 mg/kg/d for 2 days, etoposide 400 mg/m2/d for 2 days, cytarabine 1 g/m2 for 2 days, and melphalan 140 mg/m2 for 1 day
16227903|NCT01178632|Drug|Passiflora|01 tablet Passiflora p.o., b.i.d.
16227904|NCT01178632|Drug|Valeriana officinalis|Active Comparator group will receive 01 tablet of Valeriana officinalis, p.o., b.i.d.
16227905|NCT01178593|Other|Gut-focused hypnotherapy in group sessions|weekly session (45 min) of gut focused hypnotherapy (10 sessions within 12 weeks)
16227906|NCT01178554|Behavioral|psychotherapy|Usual Care therapists could use any treatment procedures they used regularly in their clinical practice.
16227907|NCT01178554|Behavioral|evidence-based treatment|Evidence-based treatment manuals were used for anxiety (Coping Cat Manual; Kendall, 1994; Kendall et al., 1994 ), depression (Primary and Secondary Control Enhancement Training; Weisz et al., 1997, 1998), and conduct problems (Defiant Children Manual; Barkley, 1997).
16227908|NCT01178554|Behavioral|modular evidence-based treatment|Therapists used the Modular Approach to Therapy for Children with Anxiety, Depression, or Conduct Problems (MATCH-ADC; Chorpita & Weisz, 2004)
16227909|NCT01178528|Drug|ivabradine|7.5 mg bd
16227910|NCT01178528|Drug|"Drug:Carvedilol and Drug:Ivabradine"|up to 12.5/5 mg bd
16227911|NCT01178528|Drug|Carvedilol|25 mg bd
16227912|NCT01178515|Other|Modification of the content of fat in milk|Comparison of three levels of fat content in cow´s milk
16227913|NCT01178515|Other|Modification of the content of cows milk|Comparison of three levels of fat content in cows' milk
16227914|NCT01178515|Other|Modification of the fat content of cows´ milk|Comparison of three levels of fat content in cow´milk
16227915|NCT01178476|Device|Hyposafe Hypoglycaemia alarm device|An EEG based hypoglycemia alarm is tested against standard glucose measurement on the risk of severe hypoglycemia
16227916|NCT01178463|Other|Biospecimen staining|The sections will be incubated with rabbit anti GPR125 followed by Cy3-conjugated anti rabbit secondary antibodies.
16227917|NCT01178463|Other|Biospecimen staining|The sections will be incubated with rabbit anti GPR125 followed by Cy3-conjugated anti rabbit secondary antibodies.
16227918|NCT01178450|Procedure|Subtotal parathyroidectomy|The procedure of choice is subtotal parathyroidectomy if the intraoperative biopsy confirms multiglandular disease and at least 3 glands are removed leaving a remanent of one normal gland
16227919|NCT01178450|Drug|Cinacalcet|Cinacalcet is initiated at a dose of 30 mg per day PO, adjusting the dose monthly (up to 90 mg per day PO) to achieve normocalcemia
16227920|NCT01178437|Device|T-VNS® Stimulator cM02 (Transcutaneous Stimulation of the Vagus Nerve)|daily, transcutaneous, electrical stimulation of the vagus nerve by the t-VNS device for a period of 9 months
16227921|NCT01178424|Behavioral|Mindfulness Based Cognitive Therapy|Mindfulness-Based Cognitive Therapy, a manualized, group skills training program (Segal et al., 2013) that is based on an integration of aspects of cognitive therapy for depression (Beck, 1979) with components of the mindfulness-based stress reduction program (Kabat-Zinn, 1990). Patients participate in 8 weekly sessions, each of which incorporates didactic and experiential learning, along with home practice of skills taught in the program.
16227922|NCT01178424|Behavioral|Cognitive Behaviour Therapy|CBT is an evidence based depression-specific psychotherapy that examines the relationship between thinking styles and the perpetuation of mood symptoms in major depression. Patients use thought records and activity scheduling, among other tools, to record and reappraise their thinking during situations where negative affect is present, both in session and for homework.
16227923|NCT01178411|Drug|Tivantinib|Tivantinib 360 mg (3 x 120 mg tablets or capsules) twice daily by mouth.
16227924|NCT01178411|Drug|Anti-Cancer Combination Therapy|Tivantinib 360 mg twice daily in combination with other anti-cancer therapy (eg, erlotinib,sorafenib, pemetrexed, docataxel, gemcitabine, irinotecan, and/or cetuximab) at the same dose and schedule in which they were administered in the original (previous) study.
16227925|NCT01178385|Behavioral|Cognitive-behavioral therapy|Therapists will work with families for 16 weekly sessions implementing the Behavioral Interventions for Anxiety in Children with Autism (BIACA) CBT program, which is a modified version of a family CBT treatment manual for typically developing children with anxiety disorders. The BIACA intervention program is flexible in nature and employs a modular format. Despite the added flexibility of the modular format, a minimum of three sessions are spent on basic coping skills and eight are spent on in vivo exposure to ensure an adequate and comparable dose of the core elements of CBT for anxiety across cases.
16228010|NCT01177813|Drug|Placebo identical to BI10773 high dose|placebo tablets once daily
16228011|NCT01177800|Drug|Placebo|Placebo matched to infliximab given at Weeks 10, 12 and 16 in Infliximab arm and at Weeks 0, 2 and 6 in Placebo arm
16228013|NCT01177787|Device|zeltiq|Cryolipolysis had been conducted for targeted fat area on thigh for 1 hour through Zeltiq machine made in Zeltiq Aesthetics.
16227926|NCT01178385|Behavioral|Treatment as Usual|Participants randomized to this arm will be instructed to continue receiving their prior interventions as recommended by their providers (e.g., psychotherapy, social skills training, behavioral interventions, family participation in family therapy or a parenting class, or pharmacological interventions). Treatment changes (e.g., medication increase, starting psychotherapy in the community) are not prohibited and will be monitored. Thus, treatment will continue as it would in standard practice; and will be monitored through periodic study assessment.
16227927|NCT01178372|Drug|Lactulose|will receive 30-60 ml of lactulose in 2 or 3 divided doses so that patient passed 2-3 semisoft stools per day
16227928|NCT01178372|Drug|Probiotics(VSL#3)|will receive VSL#3 (110 billion CFU)three times a day
16227929|NCT01178359|Drug|nitrite|
16227930|NCT01178346|Biological|NicVAX vaccine|NicVAX vaccine given 6 times over 6 months
16227931|NCT01178346|Biological|Placebo|Placebo vaccine given 6 times over 6 months
16227932|NCT01178320|Drug|Simvastatin, simvastatin plus extended-release niacin|Participants will be enrolled in this substudy only if they are candidates for the main AIM-HIGH study (NCT00120289). Participants will be randomly assigned to simvastatin or simvastatin plus niacin as a part of the main AIM-HIGH protocol, and adjustments in simvastatin and/or niacin doses will be made as per the protocol for the main AIM-HIGH study.
16227933|NCT01178307|Behavioral|Questionnaires|10 minutes to complete 3 questionnaires for development of MDASI-GIST
16227934|NCT01178307|Behavioral|Interview|Each interview will take approximately 30 minutes.
16227935|NCT01178307|Behavioral|MDASI-GIST Questionnaire|Every 4 weeks for one year
16227936|NCT01178294|Biological|OBI-1|Intravenous infusion
16227937|NCT01178281|Drug|Pomalidomide 0.5 mg|Pomalidomide 0.5 mg capsule taken by mouth once daily. Immunomodulatory agent with demonstrated efficacy in the treatment of subjects with RBC-transfusion-dependence associated with MNP-associated myelofibrosis.
16227938|NCT01178281|Drug|Placebo|Placebo Comparator to active drug; Placebo capsule taken by mouth once daily
16227939|NCT01178281|Drug|Pomalidomide|Pomalidomide 0.5 mg capsule taken by mouth once daily.
16227940|NCT01178268|Device|XIENCE V EECSS|Patients who will receive this stent.
16227941|NCT01178268|Device|CYPHER SELECT PLUS SECSS|Patients who will receive this stent.
16227942|NCT01178255|Drug|homeopathic q-potencies|individualised homeopathic medicines
16227943|NCT01178255|Drug|Placebo|placebo
16227944|NCT01178255|Other|homeopathic case history taking type I|one special homeopathic technique for case history taking
16227945|NCT01178255|Other|homeopathic case history type II|another type of homeopathic case history taking
16227946|NCT01178242|Procedure|Salivary Gland and Labial Mucous Membrane Transplantation|"Minor salivary glands (SG) will be obtain en block from the same donor site, at the inferior or superior labial mucous membrane, above the orbicularis oris muscle to correct lubrication. The thin split thickness graft of mucous membrane will be suture to the sclera with absorbable sutures"
16227947|NCT01178229|Other|Physiotherapy|"The physiotherapeutic intervention was based on the Awareness through Movement technique. Ten sessions were planed. Each session lasted three hours.
~The children of the experimental group and their parents were guided by two physiotherapist and the sessions took place in a room rounded by mirrors.
~Each session developed as follows: presentation to the parents of the somatic awareness technique for each day; movements, games, motor tales and exercises performed by the children; in each session, a guide book with cartoons was given to the children and their parents to reinforce the exercises at home to keep a long-term result.
~All the children assisted together to all the sessions and the instructions and instruments given to the children and their parents were the same for all of them."
16227948|NCT01178216|Biological|Rituxan|Rituximab (1gm) given on day# 15. Transplanted patients will receive an additional dose of Rituximab at 3M if DSA remains or 6M if denovo DSA present.
16227949|NCT01178203|Drug|Placebo|Placebo
16227950|NCT01178203|Drug|Tramadol|Tab, 100mg in 6, 12 and 24 hours after root canal treatment
16227951|NCT01178203|Drug|Novafen|325 mg in 6, 12 and 24 hours after root canal treatment
16227952|NCT01178203|Drug|Naproxen|Tab, 500 mg in 6, 12, and 24 hours after root canal treatment
16227953|NCT01178164|Genetic|Blood sampling for biological and genetic analysis|"Clinical examination
~Blood sampling for biochemical enzymatic measures of alphagalactosidase A activity in males, and genetic analysis using direct sequencing of GLA in females."
16227954|NCT01178151|Drug|Everolimus|10mg daily orally
16227955|NCT01178138|Drug|Prazosin|Prazosin or oral placebo given before methamphetamine or iv placebo to determine effects of prazosin on methamphetamine.
16227956|NCT01178125|Drug|DR-102|
16227957|NCT01178112|Drug|Trientine|Starting dose 750 mg by mouth four times a day, two times with meals and two times without meals for 28 days.
16227958|NCT01178112|Drug|Carboplatin|Starting dose area under curve (AUC) 4 by vein over two hours on day 1, and once every 28 days.
16227959|NCT01178112|Drug|Trientine MTD|Maximum tolerated dose found in MTD Dose Escalation Group; Carboplatin PK Group A, instead of starting on Day 1 of Cycle 1, starts taking trientine daily beginning on Day 2 of Cycle 1. Trientine PK Group B, 1500 mg of trientine is given once without food on Day 21 of Cycle 1 and once without food after the completion of carboplatin on Day 1 of Cycle 2.
16227960|NCT01178112|Drug|Carboplatin MTD|Maximum tolerated dose found in MTD Dose Escalation Group
16227961|NCT01178112|Other|PK Testing|Blood samples of 4 mL at following time points: 0, 30, 60 minutes, 2, 3, 4, 6, and 24 hours.
16227962|NCT01178099|Drug|Prasugrel|Oral, daily for 12 days
16227963|NCT01178086|Drug|Rituximab|Rituximab IV
16227964|NCT01178073|Drug|ambrisentan|ambrisentan (target dose: 10mg)
16227965|NCT01178073|Drug|tadalafil|tadalafil (target dose: 40mg)
16227966|NCT01178060|Other|Personalized Heart Attack and Stroke Risk|Personalized assessment of heart attack and stroke risk based on 10yr predictors with individual risk factors.
16227967|NCT01178060|Other|Standard Education|Patients received a general handout describing risk factors for heart attack and stroke.
16227968|NCT01178047|Drug|Rasagiline|Rasagiline: 1 mg/d p.o. or Placebo one tablet p.o. once daily
16227969|NCT01178034|Genetic|Calculate warfarin dose using demographic/genetic algorithm|Age, body weight and genetic to calculate warfarin dosage
16227970|NCT01178021|Drug|Chloroquine|Chloroquine 10 mg/kg on day 0 & 1 and 5mg/kg on day 2
16227972|NCT01178008|Procedure|Active acupuncture|Active acupuncture regimen consists of electroacupuncture stimulation on cranial and body acupoints which are empirical for treating depression in term of traditional Chinese medicine theory. It is done by a registered Chinese medicine practitioner with at least 3 years experience of providing acupuncture treatment. An electric-stimulator is connected to these needles to give an electric-stimulation in a continuous wave The needles will be left for 30 min and then removed. Acupuncture treatment will consist of two sessions per week for 4 consecutive weeks.
16227973|NCT01178008|Procedure|Placebo acupuncture|Streitberger's non-invasive acupuncture needles will be applied to serve as placebo control at the same acupoints and the same stimulation modality, except that the needles only affixed on the skin with adhesive tapes instead of insertion. Since all the points used are beyond patients' vision as they lay on bed, they could not visualize the acupuncture procedure. The acupuncturist, setting, treatment frequency, and duration of the treatment course are the same as the active acupuncture group.
16227974|NCT01177995|Behavioral|Social Network Intervention|Social network leaders will communicate HIV prevention messages to members of their social networks.
16227975|NCT01177982|Behavioral|Usual RBT (t-RBT)|Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach Social Club Job Club
16227976|NCT01177982|Behavioral|Reduced RBT (r-RBT)|Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach
16227977|NCT01177982|Behavioral|Abbreviated RBT (a-RBT)|Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Recreation
16227978|NCT01177982|Behavioral|Enhanced RBT (e-RBT)|Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach Social club Job Club Recovery housing CAP housing admission Recovery sponsor
16227979|NCT01177982|Behavioral|Early compliant t-RBT|r-RBT Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach t-RBT: Social club Job club
16227980|NCT01177982|Behavioral|Early non-compliant t-RBT|t-RBT Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach Social club Job club e-RBT: Recovery housing CAP short term housing admission Recovery sponsor
16227981|NCT01177982|Behavioral|Early compliant r-RBT|a-RBT Individual therapy CBT skills modules Functional assessment Behavior contracts Behavior graphing Recreation r-RBT: Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach
16227982|NCT01177982|Behavioral|Early non-compliant r-RBT|r-RBT Individual therapy Skills modules Functional assessment Behavior contracts Behavior graphing Tangible rewards MI feedback Recreation Outreach t-RBT: Social Club Job Club
16227983|NCT01177969|Behavioral|Cognitive-Behavioral Therapy|The form of treatment will involve 16 weekly meetings of about 90 minutes each. Sessions involve both the child and parent and involve teaching youth how to cope with their anxiety through a variety of behavioral techniques.
16227984|NCT01177969|Behavioral|Wait-list|A wait-list essentially involves not receiving treatment for a specified period of time (in this case 16 weeks). No active treatment is provided; rather, the family 'waits'.
16227985|NCT01177956|Biological|Cetuximab|"The initial dose of cetuximab will be 400 milligram per square meter (mg/m^2) as an intravenous (IV) infusion over 120 minutes. Subsequent weekly doses will be 250 mg/m^2 as an IV infusion over 60 minutes.
~Chemotherapy will be continued for up to a maximum of six 3-week cycles in the absence of progressive disease (PD) or unacceptable toxicity. All subjects will receive cetuximab treatment until the occurrence of PD or unacceptable toxicity to cetuximab."
16227986|NCT01177956|Drug|Cisplatin|Subjects will receive 75 mg/m^2 cisplatin as an IV infusion over 60 minutes on day 1 of each 3-week treatment cycle.
16227987|NCT01177956|Drug|5-Fluorouracil|Subjects will receive 750 mg/m^2 per day 5-FU as a continuous IV infusion over 24 hours from day 1 to day 5 of each 3-week treatment cycle.
16227988|NCT01177943|Drug|Atomoxetine|Administered orally, once.
16227989|NCT01177917|Other|Infant Formula|
16227990|NCT01177904|Other|Cease progsterone at 5|Cease administration of progsterone at first US at 5 weeks
16227991|NCT01177904|Other|control group: progesterone 8|Control group: progesterone until 8 weeks of pregnancy
16227992|NCT01177865|Other|informational intervention|
16227993|NCT01177865|Other|questionnaire administration|
16227994|NCT01177852|Drug|diphenhydramine + dropropizine + pseudoephedrine|"Group 1: fixed dose combination of diphenhydramine + dropropizine + pseudoephedrine (Notuss® syrup).
~Posology: The medicine treat will be as follows:
~- Notuss® syrup Age: 2-5 years / Dosage: 5,0 mL Age: 6-12 years / Dosage: 10,0 ml"
16227995|NCT01177852|Drug|Dropropizine and fixed dose combination of pseudoephedrine hydrochloride + brompheniramine maleate (Dimetapp® elixir).|"Dropropizine:
~Age: 2 - 3 years / Dosage: 5,0 ml Age: 4 - 12 years / Dosage: 10,0 ml
~Pseudoephedrine hydrochloride + brompheniramine maleate:
~Age: 2 - 3 years / Dosage: 2,5 ml Age: 4 - 6 years / Dosage: 5,0 ml Age: 7 - 9 years / Dosage: 7,5 ml Age: 10 - 12 years / Dosage: 10,0 ml"
16227996|NCT01177839|Other|Screening sheets|Reviewing screening sheets
16227997|NCT01177826|Procedure|Sample collection|Stool sample
16227998|NCT01177813|Drug|Placebo identical to BI10773 high dose|placebo tablets once daily
16227999|NCT01177813|Drug|BI 10773|BI 10773 low dose tablet once daily
16228000|NCT01177813|Drug|BI 10773 open label|Patients receive BI 10773 high dose tablets open label once daily
16228001|NCT01177813|Drug|Placebo identical to BI10773 low dose|placebo tablets once daily
16228002|NCT01177813|Drug|Placebo identical to BI10773 low dose|placebo tablets once daily
16228003|NCT01177813|Drug|Placebo identical to BI10773 high dose|placebo tablets once daily
16228004|NCT01177813|Drug|Placebo identical to Sitagliptin 100mg|placebo tablets once daily
16228005|NCT01177813|Drug|Placebo identical to Sitagliptin 100mg|placebo tablets once daily
16228006|NCT01177813|Drug|BI10773|BI 10773 high dose tablets once daily
16228007|NCT01177813|Drug|Sitagliptin|Sitagliptin tablets 100 mg once daily
16228008|NCT01177813|Drug|Placebo identical to Sitagliptin 100mg|placebo tablets once daily
16228009|NCT01177813|Drug|Placebo identical to BI10773 low dose|placebo tablets once daily
16229349|NCT01167712|Drug|Carboplatin|Given IV
16228014|NCT01177787|Device|electrical stimulation|Lipolysis would be done on controlateral thigh for 30 minutes through 3000 Hz- amplitude modulated frequency.
16228015|NCT01177761|Procedure|physical exercise|Two sessions/week, 50 weeks/year over 12 years of high intensity exercise training
16228016|NCT01177735|Drug|Pomalidomide|Only enough CC-4047 for 1 cycle of therapy may be provided to the patient each cycle. Participants will receive CC-4047 4 mg/day for 21 days, every 28 days. Treatment will continue until disease recurrence or untoward toxicity.
16228017|NCT01177722|Biological|DTaP-IPV-Hep B-PRP-T Vaccine|0.5 mL, Intramuscular
16228018|NCT01177722|Biological|DTaP-IPV-Hep B-PRP-T Vaccine|0.5 mL, Intramuscular
16228019|NCT01177722|Biological|DTaP-IPV-Hep B-PRP-T Vaccine|0.5 mL, Intramuscular
16228020|NCT01177722|Biological|DTaP-Hep B-IPV vaccine|0.5 mL, Intramuscular
16228021|NCT01177709|Drug|Metformin|metformin 500- 2500 mg/day. Patient received variable doses of metformin starting at 500 mg/day and increasing up to maximum of 2500 mg/day over 3-4 weeks. Dose was titrated on tolerability and side effects, especially development of hypoglycemia. This explains why different patients received different maximum doses.
16228022|NCT01177696|Behavioral|Psychotherapeutic intervention|A psychotherapeutic intervention will be 8 sessions of 90 minutes in a pilot study groups. This intervention has been initially developed for family caregivers of patients with dementia.
16228023|NCT01177683|Drug|Bendamustine|"Phase I component:
~Bendamustine escalating cohorts to determine MTD, IV over 1 hour, Days 1 and 4"
16228024|NCT01177683|Drug|Doxorubicin|"Phase I and II components:
~Pegylated liposomal doxorubicin, 30 mg/m2 IV over 1 hour, Day 4"
16228025|NCT01177683|Drug|Bortezomib|"Phase I and II components:
~Bortezomib 1.3 mg/m2 IV bolus, Days 1, 4, 8, and 11"
16228026|NCT01177683|Drug|Bendamustine|"Phase II component:
~Bendamustine at at MTD IV over 1 hour, Days 1 and 4"
16228027|NCT01177683|Drug|Filgrastim|"Phase II component:
~Filgrastim (if defined in MTD) 5 µg/kg/day SC, starting day 6 until neutrophil recovery to ANC >1000"
16228028|NCT01177657|Procedure|Stool sampling|Stool samples collected and checked for the presence of rotavirus
16228029|NCT01177644|Drug|PDS 1.0|
16228030|NCT01177631|Procedure|Operation|Operation for clinically evaluated resectable hepatocelluar carcinoma. Compare the different expression of protein between tumor, non-tumor and tumor with vascular invasion part.
16228031|NCT01177605|Other|Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebiotics|Nutritional vanilla flavored beverage - 1) Milk-based beverage containing prebiotics 2) Milk-based beverage containing no prebiotics
16228032|NCT01177592|Device|VerifyNow, Verigene|Subjects on chronic clopidogrel will be guided by VerifyNow P2Y12 assay, whereas clopidogrel naïve subjects will be guided by Verigene CYP2C19 genotyping assay. Patients on clopidogrel maintenance and/or in the control group will also be genotyped; conversely, clopidogrel naïve subjects will have VerifyNow testing prior to discharge for additional study analysis. Patients in the guided therapy group that have a measurement of ≥ 230 PRU will be reloaded with 60mg prasugrel and receive standard maintenance dosing. Similarly, clopidogrel naïve subjects that are considered CYP2C19*2 carriers will also be reloaded with 60mg prasugrel and receive standard maintenance dosing (see flow schematic).
16228033|NCT01177579|Dietary Supplement|Copper gluconate|4 or 8 mg copper gluconate/day will be assessed for efficacy of copper repletion
16228034|NCT01177566|Drug|pimecrolimus|pimecrolimus 1% cream twice daily
16228035|NCT01177566|Device|topical medical device|Eletone cream three times daily
16228036|NCT01177553|Procedure|selective laser photocoagulation of communicating vessels|Antibiotic prophylaxis is initiated within an hour of surgery and continued every 8 hours through the first post-operative day. The use of these medications is safe in pregnancy in the doses and schedules outlined. Surgery will be performed under local anesthesia for the mother using 1% xylocaine with epinephrine at the trocar entry site, and IV sedation. The patient will undergo either SLPCV or UCO depending on her choice. Patients will remain hospitalized for 24-48 hours. All subjects will be monitored during their hospital stay. Any unanticipated adverse events or serious adverse events will be reported to the IRB according to IRB reporting requirements. Prior to discharge from the hospital an investigator will perform a post-procedure ultrasound to assess fetal status
16228037|NCT01177553|Device|Expected Management|Patients randomized to expectant management will be referred back to their referring obstetrician of perinatologist and advised to undergo weekly ultrasound examinations including Doppler studies of the umbilical artery and amniotic fluid volume. Fetal growth will be assessed every 2-4 weeks. After 24 weeks patients may undergo frequent ultrasound examinations or fetal heart rate monitoring to assess fetal well being. These ultrasounds will be performed by the patient's perinatologist or obstetrician, and will be reported to the research team on an ongoing basis throughout the pregnancy.
16228038|NCT01177540|Drug|Decitabine|5 day priming with decitabine followed by Induction Chemotherapy of ADE (daunorubicin, cytarabine, etoposide).
16228039|NCT01177540|Drug|Decitabine|Induction Chemotherapy of ADE (daunorubicin, cytarabine, etoposide) only
16228040|NCT01177514|Drug|Gabapentin|Gabapentin PO. (300MG) 1 capsule the night before surgery, q12hrs the day of surgery and q8hrs for the firt 3 postoperative days.
16228041|NCT01177514|Drug|Sugar pill|Sugar pill. One capsule given the night before surgery, q12hrs on the day of surgery and q8hrs for the first 3 postoperative days.
16228042|NCT01177501|Drug|Topotecan|Six sequential doses established in the absence of limiting toxicity, as follows : 7.5 - 8.0 - 8.5 - 9.0 - 10.0 mg/m²
16228043|NCT01177488|Behavioral|Behavioral Activation Therapeutic Exposure (BATE)|This intervention combines Behavior Activation Therapy and Exposure Therapy to treat PTSD symptoms.
16228044|NCT01177475|Other|blood samples , feces samples|After the 32nd week until the 36th week or the end of hospitalization,infants received mother's native milk or substitute.
16228045|NCT01177475|Other|blood samples, feces samples|After the 32nd week until the 36th week or the end of hospitalization,infants continued mother's native milk or received substitute.
16228046|NCT01177449|Procedure|Prolotherapy|inject normal saline and 50% glugose water with 1:1 ratial in volumn
16228047|NCT01177436|Biological|Taking of urines|Urine specimens collected by vesical catheterism just before surgery. The dosage of PCA-3 and the analyse of several prostatic markers (genes coding for androgen receptor and steroid alpha-reductase type 1 and 2) will be realized on the samples of urines.
16228427|NCT01174550|Procedure|Stress Echocardiogram|Use of standard equipment for usual-care testing
16228048|NCT01177423|Procedure|Dental anesthesia|Pulpal and periapical molar and premolar sedation is randomly managed among studied population and Pulp-tester measures anesthesia minute by minute.
16228049|NCT01177410|Drug|Placebo|placebo capsules once daily for 12 weeks
16228050|NCT01177410|Drug|Mesalamine Granules 750 mg|750 mg mesalamine granules once daily for 12 weeks
16228051|NCT01177410|Drug|Mesalamine Granules 1500 mg|1500 mg mesalamine granules once daily for 12 weeks
16228052|NCT01177397|Drug|CC-223|Part A: (closed to enrollment) Dose level starts with 7.5mg daily taken by mouth in cycles of 28 days. Level increases for different patient cohorts in 100% or 50% increments until optimal dose level is established for further study. Treatment continues for as long as patient benefits (i.e., until disease progression or unacceptable toxicity). Part B: (closed to enrollment) Optimal dose is administered in 28 day cycles until disease progression.
16228053|NCT01177384|Drug|Sitagliptin phosphate|Sitagliptin, 100 mg tablet once daily, orally for 24 weeks
16228054|NCT01177384|Drug|Comparator: Placebo|Placebo, to match sitagliptin tablet, once daily, orally for 24 weeks
16228055|NCT01177384|Drug|Acarbose|Acarbose 50 mg or 100 mg tablet, 3 times daily, orally (continuing on the stable dose established prior to screening) for 24 weeks
16228056|NCT01177384|Drug|Glimepiride|Participants not meeting specific glycemic goals during the study will use glimepiride as rescue therapy. For countries where glimepiride is not available, participants will receive a sulfonylurea marketed in that country as rescue therapy.
16228057|NCT01177371|Drug|busulfan|Given orally
16228058|NCT01177371|Drug|cyclophosphamide|Given IV
16228059|NCT01177371|Procedure|allogeneic bone marrow transplantation|Patients undergo allogeneic bone marrow transplant IV over 2-3 hours on day 0.
16228060|NCT01177371|Drug|methylprednisolone|Given IV or orally
16228061|NCT01177371|Drug|methotrexate|Given IV
16228062|NCT01177371|Drug|cyclosporine|Given IV or orally
16228063|NCT01177358|Drug|Botulinum Toxin Type A|"A vial of Botulinum Toxin A containing 100U of Botox will be reconstituted with 2mL of normal saline for a concentration of 50U/mL.
~5 units (0.1mL) of Botulinum Toxin a will be injected at midline and 1.5cm lateral to midline, bidirectionally, following a thyroidectomy or parathyroidectomy."
16228064|NCT01177358|Drug|Normal Saline|0.1mL of normal saline in a placebo vial containing 2mL of normal saline will be injected along three sites (midline and 1.5cm lateral from midline) following a thyroidectomy or parathyroidectomy.
16228065|NCT01177332|Other|exercise|2 hours cycling exercise at 50 % of maximal power output
16228066|NCT01177319|Drug|Glutathione|
16228067|NCT01177306|Drug|extended release guanfacine|1-4 mg daily. Dose determined by response of ADHD symptoms to drug and by body mass limitations
16228068|NCT01177293|Drug|Amlodipine - reference|Amlodipine capsule, 10 mg, single dose, with water
16228069|NCT01177293|Drug|Amlodipine ODT - test|Amlodipine orally disintegrating tablet (ODT), 10 mg, single dose, without water
16228070|NCT01177228|Drug|Vedolizumab|Vedolizumab for intravenous infusion
16228071|NCT01177228|Drug|Placebo|Placebo intravenous infusion
16228072|NCT01177215|Procedure|Thoracic Surgery|Wedge Resection Segmental Resection Lobectomy
16228073|NCT01177202|Biological|HAC1 Vaccine|Subjects will come to the Clinical Trials Center up to 7 days prior to each vaccine dose to have blood drawn for research assays. The first dose of vaccine will be given on Day 0 and the second dose will be given 21 days later (± 3 days). Dose escalation will be staggered by at least 7 days as shown in Figure 1. Subjects from Groups G and H will be vaccinated with each of the other 6 groups. Two subjects from group A will be immunized on study day -1. The immunizations will be performed one hour apart with close monitoring. The remaining eight subjects from Group A will be immunized on study day 0. All subsequent immunizations for each group will occur on the same day. The principal investigator and the medical monitor will review all adverse events and make a determination on whether it is safe to proceed to the next higher dosage group. The control and reference vaccine groups can be vaccinated starting anytime after screening.
16228074|NCT01177189|Dietary Supplement|Vitamins C, E, and alpha lipoic acid|Oral antioxidant cocktail or placebo to be consumed daily
16228075|NCT01177176|Other|Extended Care Management|Telephone-based care management of tobacco cessation for 3 months after hospital discharge that features 2 innovations: (1) to increase medication use, smokers receive a free refillable 30-day sample of their choice of FDA-approved smoking cessation medication (nicotine replacement, bupropion, or varenicline) at hospital discharge; (2) to increase counseling cost-effectiveness, interactive voice recognition (IVR) technology is used to make automated telephone calls to identify the smokers seeking or most likely to benefit from continued counseling after hospital discharge.
16228076|NCT01177176|Other|Standard Care|Usual care provided to hospitalized smokers during their inpatient stay, with no post-discharge care management plan
16228077|NCT01177163|Drug|Placebo|one placebo capsule once daily for 3 days immediately prior to randomization to double-blind treatment with JNJ 28431754 or placebo
16228078|NCT01177163|Drug|JNJ 28431754 300 mg/placebo|one 300-mg capsule of JNJ-28431754 or placebo twice-daily for 4 weeks
16228079|NCT01177163|Drug|JNJ 28431754 100 mg/placebo|one 100-mg capsule of JNJ-28431754 or placebo once-daily for 4 weeks
16228080|NCT01177150|Drug|JNJ-28431754/ Placebo|Part 1: One oral dose of JNJ 28431754 (10 mg to 600 mg) or matching placebo will be administered after an overnight fast of at least 10 hours .For patients who receive a previously tested dose as 2 equally divided doses, the evening dose will be administered at 10 hours after the morning dose.
16228081|NCT01177150|Drug|JNJ-28431754|Part 2: A single dose of JNJ-28431754 will be orally administered on 2 occasions (14 days apart) after an overnight fast of at least 10 hours with and without a standard meal.
16228082|NCT01177137|Device|Conventional sound generator (SG)|Conventional SGs: Tranquil model sound generators (General Hearing Instruments, Inc.) are either inside or outside-the-ear devices that generate low-level noise, which is set at or just below the patient's mixing point (i.e., the noise level that just blends with the study participant's tinnitus)
16228083|NCT01177137|Device|Placebo sound generator (placebo SG)|Tranquil model placebo sound generators (General Hearing Instruments, Inc.) are either inside or outside-the-ear devices that generate a sound different from the active devices.
16228104|NCT01176955|Drug|Benzoyl peroxide 5% gel|Topical benzoyl peroxide 5% gel, to be used once daily to the face.
16228105|NCT01176942|Dietary Supplement|Probiotic bacterium Bifidobacterium lactis|Probiotic placebo controlled intervention
16228084|NCT01177137|Behavioral|Standard of Care (SC)|The standard of care treatment will be similar to that typically provided to patients with severe tinnitus at participating military medical centers and as described in the American Speech-Language-Hearing Association (ASHA) Preferred Practice Patterns in Audiology (ASHA, 2006). Tinnitus management will be based on the patient's complaints, history, audiologic evaluation, and self-assessment. The goal of the tinnitus management is to reduce negative cognitive, affective, physical, and behavioral reactions to tinnitus and to improve the patient's well-being and quality of life. Specific treatment recommendations will be individualized to reflect the participant's concerns and abilities, as well as his or her engagement in the decision-making process regarding treatment options.
16228085|NCT01177137|Behavioral|Directive Counseling (DC)|Directive Counseling (DC): two-hour educational session during which the patient is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, provide instruction on anatomy and physiology of hearing and tinnitus, introduce the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and describe and recommend the use of ST and environmental sound in the habituation process.
16228086|NCT01177137|Behavioral|Directive Counseling (DC)|Directive Counseling (DC): two-hour educational session during which the patient is given information regarding the nature of the tinnitus problem and related problems such as hearing loss and sound intolerance; visual aids to review the audiological/tinnitus/ hyperacusis evaluation, provide instruction on anatomy and physiology of hearing and tinnitus, introduce the Jastreboff neurophysiological model of tinnitus and related concepts of habituation, and describe and recommend the use of ST and environmental sound in the habituation process.
16228087|NCT01177124|Behavioral|MBSR 6 Weeks Program|MBSR is a clinical program that provides systematic training to promote stress reduction by self-regulating arousal to stress. The goal of training is to teach participants to become more aware of their thoughts and feelings, and through meditation practice, to have the ability to step back from thoughts and feelings during stressful situations that contribute to increased emotional distress. The intervention incorporates simple yoga, sitting meditation, body scan, and walking meditation in a 6-week program (Kabat-Zinn et al. 1985; Teasdale et al. 1995).
16228088|NCT01177111|Other|Sunflower seed oil|Locally manufactured refined sunflower seed oil will be provided to pregnant women late in pregnancy and community workers will promote its daily use during massage of newborns during the first month of life
16228089|NCT01177111|Other|Mustard seed oil|Locally manufactured mustard seed oil will be provided to pregnant women late in pregnancy and community workers will promote its daily use during massage of newborns during the first month of life
16228090|NCT01177098|Drug|bimatoprost /timolol formulation A fixed combination ophthalmic solution|One drop of bimatoprost/timolol formulation A fixed combination ophthalmic solution administered in each eye every morning for 12 weeks.
16228091|NCT01177098|Drug|bimatoprost/timolol fixed combination ophthalmic solution|One drop of bimatoprost 0.03%/timolol 0.5% fixed combination ophthalmic solution (Ganfort®) administered in each eye every morning for 12 weeks.
16228092|NCT01177085|Behavioral|Weight-loss and weight-maintenance diets|Participants will be given a personalized diet plan, with or without use of mushrooms as part of the diet, at a calorie level sufficiently restricted to result in a 20 lb weight loss over a period of 6 months, followed by a weight maintenance diet for a further 6 months.
16228093|NCT01177072|Other|Cognitive Processing Therapy|12 sessions of cognitive processing therapy. Sessions are expected to be approximately one week apart. Although each counseling session is designed to be carried out one week apart for a total of 12 weeks, there are many reasons why a session will be missed. Our estimation is that a single client will require 4-5 months to complete the therapy.
16228094|NCT01177072|Other|Components-Based Intervention|This is a 'components-based' intervention include psychoeducation, relaxation, life-enhancing skills (problems solving and safety planning), exposure, and cognitive processing of life problems and traumatic events. The duration of sessions are approximately one hour), the expected frequency of treatment is weekly, and recommended number of sessions are 12.
16228095|NCT01177059|Genetic|OZ1 transduced cells|Long term follow up of previously infused OZ1 transduced cells
16228096|NCT01177033|Other|Best endovascular treatment or Best surgical treatment|Intervention type I: Best endovascular treatment (stent-protected angioplasty). Intervention type II: Best surgical treatment (femoro-popliteal bypass above the knee with autologous vein (1° choice) or a prosthetic graft (if vein is not available).
16228097|NCT01177020|Other|Biological specimen|Biological specimen taken from placenta
16228098|NCT01177007|Device|TheraSphere, Yttrium-90 glass Microspheres|Patients with unilobar disease will receive 120 ± 10% Gy (dose may be lower if clinically indicated) of TheraSphere to the affected lobe. Patients presenting with bilobar disease will have their liver assessed and the lobe presenting the highest treatment priority will receive the first treatment of TheraSphere. Assigning priority of lobes to receive treatment is based on tumor bulk, associated clinical symptoms attributed to the tumor and technical/angiographic considerations. In patients with bilobar disease where the second lobe does not require immediate treatment, or in unilobar disease where tumors develop in the untreated lobe, additional TheraSphere treatment may be administered at any subsequent time. A treatment may consist of a single 120 ± 10% Gy infusion to a lobe, or, if angiography indicates the need, the 120 ± 10% Gy dose may be split into multiple infusions per lobe to ensure delivery of a total of 120 ± 10% Gy to each treated lobe.
16228099|NCT01176994|Device|Formulations for in-vivo fixation|Formulations are comprised of non-toxic ingredients used in dermatology.
16228101|NCT01176968|Drug|Eplerenone|Maximum dose of 2x25 mg film coated tablets per day for the duration of the study (approximately 18 months maximum). Lower doses may be administered determined by blood biochemistry data.
16228102|NCT01176968|Drug|Placebo|Matching placebo tablets
16228103|NCT01176955|Behavioral|Internet survey|A weekly email link will be generated to an internet survey which questions subjects about their acne severity, compliance with the study medication, and attitudes toward acne and the study medication.
16228106|NCT01176929|Other|Usual treatment and Prevention program|"Prevention program of recurrent suicidal acts includes three interventions:
~A series of three telephone calls ( the second week , one month and three months after discharge from hospital )
~A systematic telephone contact with the referring physician
~A telephone helpline for people who made a suicide attempt and referring physicians."
16228107|NCT01176929|Other|Usual Treatment|Usual Treatment
16228112|NCT01176890|Drug|GLP-1|"1.2 pmol/kg/min GLP-1 will be infused intravenously during the four hour meal test (100 g Ny NAN1 and 1.5 g paracetamol dissolved in 300 ml water) ingested over 10 minutes.
~After four hours an ad libitum meal will be supplied"
16228113|NCT01176890|Other|Saline|"Saline (isotonic NaCl) will be infused intravenously during the four hour meal test (100 g Ny NAN1 and 1.5 g paracetamol dissolved in 300 ml water) ingested over 10 minutes.
~After four hours an ad libitum meal will be supplied"
16228114|NCT01176877|Behavioral|"Scripted lecture (educational information talk)"|This scripted lecture will be approximately 5 minutes in length and will include 3 picture examples of keloid and hypertrophic scarring as well as an opportunity to ask questions.
16228115|NCT01176864|Procedure|Double-balloon enteroscopy|Double-balloon enteroscopy
16228116|NCT01176864|Procedure|Single-balloon enteroscopy|Single-balloon enteroscopy
16228120|NCT01176825|Behavioral|cognitive-behavior therapy (CBT)|14 sessions of individual cognitive-behavior therapy. Sessions last 50-60 minutes and are held weekly. 2 optional monthly booster sessions may also be held after the end of treatment.
16228121|NCT01176799|Drug|Arm A|Doxorubicin 60mg/m2 day 1 Cyclophosphamide 600mg/m2 day1, every 3 weeks x 4 cycles
16228122|NCT01176799|Drug|Arm B|Days -13 (or -7) to day 0 (total 7 or 14 days) - oral sunitinib daily Cycle 1: day 1 - Cycle 1 AC (60/600mg/m2); days 15-21 - oral sunitinib daily Cycle 2: day 1 - Cycle 2 AC (60/600mg/m2); days 15-21 - oral sunitinib daily Cycle 3: day 1 - Cycle 3 AC (60/600mg/m2); days 15-21 - oral sunitinib daily Cycle 4: day 1 - Cycle 4 AC (60/600mg/m2)
16228123|NCT01176786|Other|Culture Swabs, Rodac Plate Cultures|Culture swab is taken when breast tissue expander is removed and when breast implant is placed in breast pocket. Rodac Plate cultures are taken after the surgical procedure of the surgeons dominant palm, forearm of gown and subject's drape closest to the breast.
16228124|NCT01176773|Device|hyaluronic acid gel|Dosage per Investigator's discretion to obtain lip treatment goal; 1 touch-up treatment is allowed 14 days after initial treatment. Maximum total volume per subject is 2.0 mL
16228125|NCT01176760|Drug|Dipeptidyl peptidase 4 (DPP 4) inhibitor|One tablet (50 mg)of DPP4 inhibitor is to be taken 12 and 1 hours before start of the oral glucose tolerance test (50 g glucose and 1.5 g paracetamol dissolved in 300 ml water)on day 3
16228126|NCT01176760|Other|oral glucose|50 g glucose dissolved in 300 ml water with 1,5 g paracetamol is to be ingested orally within the first 15 minutes.
16228128|NCT01176734|Device|tVNS-Device|Active treatment with the t-VNS device.
16228129|NCT01176721|Device|t-VNS verum|Active stimulation of the left auricle by t-VNS
16228130|NCT01176721|Device|t-VNS placebo|Sham stimulation of the left auricle with the t-VNS device
16228131|NCT01176708|Drug|dipeptidyl peptidase 4 (DPP4) inhibitor|One tablet (50 mg)of DPP4 inhibitor is to be taken 12 and 1 hours before start of the oral glucose tolerance test (50 g glucose and 1.5 g paracetamol dissolved in 300 ml water)on day 3
16228132|NCT01176708|Other|oral glucose|50 grams glucose dissolved in 300 ml water with 1.5 grams paracetamol
16228133|NCT01176708|Other|intravenous glucose|1.5 g paracetamol dissolved in 50 ml water is to be ingested orally within the first 2 minutes. Intravenous glucose is supplied in an amount to match the plasma glucose during the oral glucose tolerance test
16228134|NCT01176695|Drug|fish oil containing lipid emulsion|medium chain triglycerides, long chain triglycerides, omega-3 fatty acid containing triglycerides
16228135|NCT01176695|Drug|MCT/LCT containing lipid emulsion|medium chain triglycerides, long chain triglycerides
16228136|NCT01176669|Drug|Apatinib|Apatinib was administratered at 750 mg/d in Phase IIa. The actual average dose intensity delivered was 525 mg/d due to toxicities. So, in Phase IIb, the starting dose of apatinib will be 500mg/d. Two dose reductions will be allowed to 375 and then 250 mg/d.
16228137|NCT01176643|Other|Standard care plus Yoga|Participants will be asked to complete two yoga classes weekly over a period of eight weeks.
16228138|NCT01176617|Device|Reveal XT implantable loop recorder|All study participants will receive the Reveal XT implantable loop recorder immediately after completion of the ablation procedure.
16228139|NCT01176604|Radiation|Yttrium Y 90 Glass Microspheres|Given via catheter
16228140|NCT01176591|Drug|Placebo session 1, Aprepitant session 2|placebo in session 1, Aprepitant 80 mg in session 2, oral administration.
16228141|NCT01176591|Drug|Placebo session 1, Placebo session 2|Placebo, one per session, oral administration
16228142|NCT01176578|Other|Aerobic Exercise Training|6 months of aerobic exercise training, 3 days per week
16228143|NCT01176565|Drug|Intravenous nicardipine hydrochloride|"IV nicardipine is initiated at a rate of 5 mg/hr, is continued, and is increased by 2.5 mg/hr increments every 15 min until the target SBP or maximum dose of 15 mg/hr is reached. If SBP is above the target SBP despite infusion of the maximum nicardipine dose for 30 minutes, a second agent may be used (Labetalol 5-20 mg IV bolus every 15 min; diltiazem/urapidil in countries without labetalol) for another hour. Nicardipine infusion is decreased incrementally or is stopped if SBP falls below the desired treatment range.
~Fluid bolus for SBP still falling below 110 mmHG (millimeters of mercury) with nicardipine off is given to prevent organ hypoperfusion. Vasopressor agents are not used unless symptoms related to or possibly exacerbated by hypoperfusion are present."
16228428|NCT01174550|Procedure|Nuclear Stress Test|Use of standard equipment for usual-care testing
16228144|NCT01176552|Drug|GM-CSF, IFN alpha and IL-2|Treatment during 6 months: GM-CSF, 1 mcg/kg, 3 times per week, subcutaneously, first week of each month; IFN, 10 MIU, 3 times per week, subcutaneously, second week, and IL-2, 1 MIU, 3 tiw, intravenously, third week. Fourth week of each month was free from treatment.
16228145|NCT01176539|Device|Non-Contact Respiratory Rate Monitor|"The Non-Contact Respiratory Rate Monitor provides a measurement of respiratory rate at a single point in time for neonates, pediatrics and adults.
~The Non-Contact Respiratory Rate Monitor provides a continuous monitor, measurement, and display of the respiratory rate, respiratory patterns, depth of breath, history/events and respiratory activity of a subject for neonates, pediatrics, and adults."
16228146|NCT01176513|Drug|GE-148 (18F)|All subjects will receive an i.v. dose of GE-148 (18F) Injection at 10 mCi (370 MBq) to provide adequate image quality throughout the specified imaging period.
16228147|NCT01176500|Drug|(18)Fluciclatide|
16228148|NCT01176487|Other|questionnaire administration|
16228149|NCT01176487|Procedure|quality-of-life assessment|
16228150|NCT01176487|Radiation|3-dimensional conformal radiation therapy|
16228151|NCT01176487|Radiation|palliative radiation therapy|
16228152|NCT01176487|Radiation|whole-brain radiation therapy|
16228153|NCT01176474|Biological|NY-ESO-1 157-165 (165V)|"The vaccine contains two peptides from two different proteins (peptides are pieces that make up proteins) called gpl00 and NY-ES0-1.
~Route of Administration: When prepared as a vaccine emulsion with Montanide ISA 51 VG, the vaccine is given by deep subcutaneous injection.
~Method of Administration: The 0.5 mg vaccine emulsion dose is administered as a 1 mL injection (0.5 mg/1 mL) as a deep subcutaneous injection in the anterior thigh of the same extremity. Injections should be separated by at least 3 cm to avoid the formation of coalescent granulomas. All 4 peptides (total of 6 injections) will be administered in the same thigh and alternating thighs will be used for each subsequent treatment."
16228154|NCT01176474|Drug|Nivolumab|"Nivolumab (BMS-936558) is a fully human monoclonal antibody (HuMAb) against programmed death-1 (PD-1).
~Nivolumab will be given at the following dosages: 1, 3, or 10 mg/kg.
~Nivolumab will be administered as an i.v. infusion, using a volumetric pump with a 0.2 micron in-line filter at the protocol-specified dose(s) and rate."
16228155|NCT01176474|Biological|gp100:280-288 (288V)|"The vaccine contains two peptides from two different proteins (peptides are pieces that make up proteins) called gpl00 and NY-ES0-1.
~Route of Administration: When prepared as a vaccine emulsion with Montanide ISA 51 VG, the vaccine is given by deep subcutaneous injection.
~Method of Administration: The 0.5 mg vaccine emulsion dose is administered as a 1 mL injection (0.5 mg/1 mL) as a deep subcutaneous injection in the anterior thigh of the same extremity."
16228156|NCT01176474|Drug|Montanide ISA 51 vegetable grade (VG)|"Route of Administration: Administer peptide vaccine emulsions prepared with Montanide® ISA 51 VG by deep subcutaneous injection.
~Method of Administration: Divide peptide vaccine emulsion dose volumes of greater than 1.5 mL into 2 or more injections. Administer injections typically into the anterior thigh deep subcutaneous tissue. Perform subsequent injections in rotating sites. Use a 20 or 21 gauge needle for deep subcutaneous injection of the peptide vaccine emulsion."
16228157|NCT01176474|Drug|Ipilimumab|"Ipilimumab will be given at the following dosage: 3 mg/kg.
~Ipilimumab will be administered as an i.v. infusion, using a volumetric pump with a 0.2 micron in-line filter at the protocol-specified dose(s) and rate."
16228158|NCT01176474|Procedure|Apheresis Procedure|"Some blood will be removed from the participant's veins and processed by a machine to remove a small portion of the white cells. The rest of the blood will be returned into their veins. This procedure is called apheresis. Apheresis is done to collect cells to allow the investigators to understand how their immune system is functioning before and after receiving nivolumab and vaccine. This will be done for research purposes only. The red cells and blood clotting cells will not be permanently removed during this procedure. White blood cells will need to be removed by apheresis before participants receive the study drug."
16228159|NCT01176461|Biological|MART-1|THIS PEPTIDE REMOVED FROM STUDY ON 1/1/2013. MART-1:26-35(27L) peptide vaccine
16228160|NCT01176461|Biological|NY-ESO-1|NY-ESO-1 peptide vaccine
16228161|NCT01176461|Biological|gp100:209-217(210M)|THIS PEPTIDE REMOVED FROM STUDY ON 1/1/2013. gp100:209-217(210M) peptide vaccine
16228162|NCT01176461|Biological|gp100:280-288(288V)|gp100:280-288(288V) peptide vaccine
16228163|NCT01176461|Drug|Montanide ISA 51 VG|Administer peptide vaccine emulsions prepared with Montanide® ISA 51 VG by deep subcutaneous injection.
16228164|NCT01176461|Biological|BMS-936558|BMS-936558 is a fully human monoclonal antibody (HuMAb) against programmed death-1 (PD-1). Level 1: 1 mg/kg cohort; Level 2: 3 mg/kg cohort; Level 3: 10 mg/kg cohort; Level 4: 3 mg/kg prior ipi gr 0/1/2 cohort; Level 5: 3 mg/kg prior ipi gr 3 cohort; Level 6: 3 mg/kg BMS-936558 (no peptide vaccine; human leukocyte antigen [HLA] unrestricted)
16228165|NCT01176448|Device|Fractionated laser|Fractionated laser in the form of the Re:Pair CO2 laser manufactured by Solta Medical.
16228166|NCT01176448|Device|Dermabrasion|Diamond Fraise Dermabrasion will be performed in standard fashion down to papillary dermis.
16228167|NCT01176435|Drug|Levodopa|Solution taken orally three times a day.
16228168|NCT01176435|Drug|Levodopa|Solution taken orally three times a day.
16228169|NCT01176435|Drug|Placebo|Solution taken orally three times a day.
16228170|NCT01176422|Genetic|Blood sample|Blood samples will be collected before and after treatment completion.
16228171|NCT01176409|Drug|Valacyclovir|Valacyclovir will be used at two different dosages (1g po BID and 500mg po BID) to be used for 12 weeks. Supplied as 500mg caplets.
16228172|NCT01176409|Drug|Placebo|Placebo, supplied as caplets identical in appearance, odour and taste to valacyclovir 500mg caplets.
16228173|NCT01176396|Other|Caries prevention active intervention|"Subjects will be treated related to their caries risk:
~Low Caries Risk
~The intervention and control treatments for low caries risk are the same:
~4 bitewing radiographs dental prophylaxis Oral Hygiene instruction OTC toothpaste with fluoride (1,100 ppm F) 2x daily Periodic oral exam after 12 months Bitewings after 12 months
~Moderate Caries Risk In addition to the treatment above the intervention group receives OTC fluoride rinse as well as xylitol candies or gums.
~High Caries Risk The high caries risk level subjects will receive a prescription 5,000 ppm F toothpaste, will rinse 1 day for one week per months with a Chlorhexidine rinse to reduce the bacteria level, and receive a fluoride varnish in the dental office."
16228199|NCT01176175|Drug|Progesterone|Progesterone microspheres injectable suspension 50 mg, intramuscular weekly injection for a total of 7 doses.
16228174|NCT01176396|Other|control treatment|"Subjects will be treated related to their caries risk:
~Low Caries Risk
~The intervention and control treatments for low caries risk are the same:
~4 bitewing radiographs dental prophylaxis (if prescribed) Oral Hygiene instruction OTC toothpaste with fluoride (1,100 ppm F) as currently used by patient Periodic oral exam after 12 months Bitewings after 12 months
~Moderate Caries Risk Control group receives regular dental care (placebo rinse and gums without active ingredients allow blinding).
~High Caries Risk The control treatment group receives regular dental care (regular 1,100 ppm F toothpaste, a placebo rinse without antibacterial ingredients and placebo varnish to allow blinding)."
16228175|NCT01176383|Genetic|Respiragene test and risk score|This 12 gene test used with other data (family history, age and spirometry result) to calculate lifetime risk of lung cancer in smokers who do not quit smoking. This intervention is expected to be a motivator to quit.
16228176|NCT01176370|Device|C-Pulse™ (Implantable Counterpulsation Therapy)|Implantation of a heart assist device that provide counterpulsation without blood contact for an extended period.
16228177|NCT01176370|Device|C-Pulse™ (Implantable Counterpulsation Therapy)|Implantation and activation of counterpulsation therapy for the full duration of the study period. The device may be turned off briefly for personal hygiene, etc.
16228178|NCT01176344|Drug|Vitamin D|50,000 IU (1.25 mg) cholecalciferol capsules once monthly for 2 years
16228179|NCT01176344|Drug|Placebo|Inert placebo capsules once monthly for 2 years.
16228180|NCT01176331|Procedure|20 and 23 gauge pars plana vitrectomy|
16228181|NCT01176318|Drug|Erdosteine|capsule 300mg twice daily for 10 days
16228182|NCT01176318|Drug|Placebo|placebo capsule, twice daily for 10 days
16228183|NCT01176292|Device|Rotating Platform High-Flex Cruciate Substituting TKA|
16228184|NCT01176292|Device|Rotating Platform Cruciate Substituting TKA|
16228185|NCT01176279|Procedure|Manual and automated washing of the peripherical lines|"The extractions of the blood for the analysis of the glycaemia will be made puncturing the needless connector inserted in the distal 3-way stopcock key once an hour during 48 hours.
~Obtain 2cc of blood using the arterial blood sampling syringe connected to the proximal key. This volume of rejection is reserved in the syringe itself.
~In accordance with the current protocol of disinfection, the needless connector inserted on the distal key will be disinfected. With a disposable sterile syringe the needless connector is punctured and a minimum blood amount is obtained for the determination of the glycaemia.
~Once the sample has been obtained, the rejection volume reserved is returned to the bloodstream. This arterial blood sampling syringe is cleaned aspirating serum manually in order to wash the line.
~Additional line washing is made through the fast flow valve of the system BD DTXPlus ™."
16228186|NCT01176279|Procedure|Automated washing of the peripherical lines|"The extractions of the blood for the analysis of the glycaemia will be made puncturing the needless connector inserted in the distal 3-way stopcock key once an hour during 48 hours.
~In accordance with the current protocol of disinfection, the two needless connectors inserted on the two 3-way stopcock keys will be disinfected.
~With a disposable sterile syringe the needless connector on proximal 3-way stopcock is punctured and 2cc of blood are aspirated. This volume of rejection is reserved in the syringe itself and it is not disconnected.
~With a second disposable sterile syringe the needless connector on distal 3-way stopcock key is punctured and a minimum blood amount is obtained for the determination of the glycaemia.
~Once the sample has been obtained, the rejection volume reserved in the disposable syringe connected to the proximal 3-way stopcock is returned to the bloodstream.
~Line washing will be made through the fast flow valve of the system BD DTXPlus ™."
16228187|NCT01176266|Drug|asfotase alfa|
16228188|NCT01176253|Procedure|Blood draw|Blood draw for Type I DM patients will be taken every 4 weeks for 1 year post diagnosis/healthy volunteers will have 1 blood draw
16228189|NCT01176240|Drug|Droxidopa|100 mg and 200 mg capsules 100, 200, 300, 400, 500, 600mg TID dosing for up to 8 weeks of treatment
16228190|NCT01176240|Other|Placebo|Placebo
16228191|NCT01176227|Dietary Supplement|Kyodophilus multi-strain probiotic capsules|"The Kyo-Dophilus study product is a gelatin capsule containing three proprietary probiotic bacterial strains. The total quantity of bacteria per capsule is 1.5 billion colony forming units (1.5 x 109 cfu) and is composed of the following strains:
~Lactobacillus gasseri KS-13 1.2
~Bifidobacterium bifidum G9-1 0.15
~Bifidobacterium longum MM-2 0.15
~Subjects will be provided with two bottles containing 30 capsules each of matching placebo upon randomization. Subjects will be instructed to take one capsule with breakfast daily for the full 12 weeks duration of the trial. While one bottle contains enough capsules for the time frame between each visit, two bottles have been provided to permit a surplus in the event scheduling conflicts arise. The third bottle, providing the remainder or study capsules, will be provided at visit 2."
16228192|NCT01176227|Dietary Supplement|Kyodophilus Matching Placebo Capsules|Subjects will be provided with two bottles containing 30 capsules each of matching placebo upon randomization. Subjects will be instructed to take one capsule with breakfast daily for the full 12 weeks duration of the trial. While one bottle contains enough capsules for the time frame between each visit, two bottles have been provided to permit a surplus in the event scheduling conflicts arise. The third bottle, providing the remainder or study capsules, will be provided at visit 2.
16228193|NCT01176214|Procedure|Early tracheostomy|"Patients with supratentorial ICH who require mechanical ventilation, fulfill the inclusion criteria, and have been randomized to the treatment arm will receive an early tracheostomy within 72h after symptom onset."
16228194|NCT01176214|Procedure|Late tracheostomy|"Compared to the early tracheostomy-group, those patients who have been randomized to late tracheostomy will undergo conventional tracheostomy between day 12 - 14 if extubation fails"
16228195|NCT01176201|Drug|SLV337 suspension|400 mg experimental
16228196|NCT01176201|Drug|SLV337 capsule|5 x 200 mg immediate release capsule
16228197|NCT01176188|Other|Comfort Care|The intervention will consist of two parts: (1) A 15-20 minute period of parental soothing at the bedside comprised of calming activities which the child and parents are familiar with; (2) A quiet period will follow, in which earmuffs are applied over the child's ears to block auditory stimulation. The intervention will take place twice/24 hours, up to a maximum of 72 hours. Total time of first (daytime) intervention will be 2 hours, and of second (night-time) intervention will be 7 hours.
16228198|NCT01176188|Other|Usual care|Usual nursing care for the child in the Pediatric Intensive Care Unit, including usual parental involvement and usual exposure to unit noise levels.
16229350|NCT01167712|Procedure|Computed Tomography|Correlative studies
16228200|NCT01176175|Drug|Progesterone|Progesterone microspheres injectable suspension 100 mg, intramuscular weekly injection for a total of 7 doses.
16228201|NCT01176175|Drug|Progesterone|Progesterone microspheres injectable suspension 200 mg, intramuscular weekly injection for a total of 7 doses.
16228202|NCT01176175|Drug|Progesterone|Progesterone microspheres injectable suspension 300 mg, intramuscular weekly injection for a total of 7 doses.
16228203|NCT01176149|Behavioral|SMBG plus intensive education|
16228204|NCT01176136|Behavioral|Homework, Organization, and Planning Skills (HOPS) Intervention|HOPS is a 16 session school-based intervention. School counselors and psychologists deliver the intervention during the school day. Each session lasts 20 minutes. Initially, sessions are 2 times per week and the entire HOPS intervention is completed in 11 weeks. The study uses a waitlist control design. HOPS intervention participants (Arm 1) receive the intervention in the fall quarter of the school year and Treatment As Usual participants (Arm 2) receive the intervention in the spring quarter.
16228205|NCT01176123|Behavioral|Cognitive Behavioral Therapy for Insomnia|Cognitive Behavioral Therapy for Insomnia
16228206|NCT01176110|Device|LMA Perfect Temp|The LMA PerfecTemp™ patient warming system combines warming beneath the patient and advanced pressure reduction to combat hypothermia and decubitus ulcers. This device is used during the interventional minimal invasive valve replacement with unprecedented ease and safety
16228207|NCT01176097|Drug|AZD5658|oral suspension, escalating single doses
16228208|NCT01176097|Drug|Placebo|oral suspension,single doses
16228209|NCT01176084|Behavioral|low carbohydrate diet|
16228210|NCT01176084|Behavioral|low carbohydrate diet and exercise|
16228211|NCT01176058|Drug|Anidulafungin/Fluconazole|Anidulafungin:IV,100 mg daily preceded by an initial 200 mg dose on Day 1, 14 - 42 days Fluconazole: IV/Oral, 400mg,QD,14 - 42 days
16228212|NCT01176032|Drug|Aliskiren|Aliskiren 300 mg film coated tablets
16228213|NCT01176032|Drug|Losartan|Losartan 100 mg tablets
16228214|NCT01176032|Drug|Amlodipine|Amlodipine 5mg was given to patients who did not achieve the required blood pressure (<140/90 mmHg) after 8 weeks (visit 3)of treatment at the maximum doses of study medication in addition to the study medication in order to reach the required BP. at visit 4 (week 18) the dose of amlodipine was increased to 10mg if the required level (<140/90 mmHg) was still not achieved.
16228215|NCT01176032|Drug|Hydrochlorothiazide (HCTZ)|HCTZ 12.5mg was prescribed at visit 5 (week 26) if the required values (<140/90 mmHg) had not been reached.
16228216|NCT01176019|Device|Information about Prenatal Screening and Diagnosis|15-20 minute interactive video about prenatal screening and diagnosis given on day of recruitment.
16228225|NCT01175980|Other|Laboratory Biomarker Analysis|Correlative studies
16228226|NCT01175980|Drug|Vorinostat|Given PO
16228227|NCT01175967|Other|Palliative Performance Scale version 2 (PPSv2)|PPSv2 is arrayed on a scaled from 10 (bedbound) to 100 (full ambulation) at 10 points increment. It will be administered beginning at baseline, post surgery (at the first post-operative clinic visit), 14-21 days post chemotherapy (post cycle 3 and post cycle 6), and at the first follow-up visit
16228228|NCT01175967|Other|McCorkle Symptom Distress Scale (SDS)|A 13-item scale of SDS is used to indicate the degree of distress for a given symptom on a 5 point Likert Scale, ranging from 1 (least amount of distress) to 5 (extreme distress). This will be administered at baseline, post surgery (at the first post-operative clinic visit), 14-21 days post chemotherapy (post cycle 3 and post cycle 6), and at the first follow-up visit
16228229|NCT01175967|Other|Geriatric Assessment|This will evaluate the subject's overall geriatric status. The first part will be filled out by the study team and the second half of the assessment will be populated with information provided by the subject. This will be completed at baseline, 2 weeks post-surgery and 14-21 days after completing cycle 3 and cycle 6.
16228230|NCT01175967|Other|Medical Records Abstraction|Data collected from medical records will include information on surgical complications and chemotherapy toxicities, dose reductions, and any change in choice of chemotherapy drug. This will occur continuously throughout the study.
16228231|NCT01175954|Drug|Lacosamide|Lacosamide will be titrated starting from visit 1 for 2 weeks (50mg bid) and maintained at 100mg bid for the rest of the study period. Dose Adjustments allowed up to 400 mg/day.
16228232|NCT01175954|Drug|Lacosamide|Lacosamide will be titrated starting from visit 1 for 2 weeks (50mg bid) and maintained at 100mg bid for the rest of the study period.
16228233|NCT01175941|Drug|NRL001|10 mg NRL001 in a 2 g suppository, administered once daily for 7 days
16228235|NCT01175928|Device|Sham device|Home treatment with PCD to both legs: 2 sessions of 1 hour duration every day
16228236|NCT01175928|Device|NormaTec PCD (Peristaltic Pulse PCD)|Home treatment with PCD to both legs: 2 sessions of 1 hour duration every day
16228237|NCT01175915|Other|Western therapy|"Adopting physical cooling therapy, including physical cooling paste or warm bathing, when patient's body temperature is lower than 38.5 degree Celsius;
~Using Ibuprofen suspension when patient's temperature higher than 38.5 degree Celsius lasting for more than 2 hours;
~No specific treatment for tetter and ulcer, but Bingpeng powder, Watermelon tablet or frost for oral herpes.
~Intervention time: 3-7 days; Follow-up time: 3 days."
16228238|NCT01175915|Other|Reduning Injection|"Lifestyle counseling, vitamin supplementation if necessary, and non-use of antibiotics;
~Reduning Injection, 0.5~15ml, depending on patient's condition, IV per day, or according to the instruction;
~Using Ibuprofen suspension when patient's temperature higher than 39 degree Celsius lasting for more than 2 hours.
~Intervention time: 3-7 days; Follow-up time: 3 days."
16228239|NCT01175915|Other|Reduning Injection plus western therapy|"General treatment including lifestyle counseling, vitamin supplementation if necessary, non-use of antibiotics, and symptomatic treatment as follows;
~Symptomatic treatment by western therapy adopting the same plan in western therapy comparator group;
~Symptomatic treatment by Reduning Injection adopting the same plan in Reduning Injection experimental group.
~Intervention time: 3-7 days; Follow-up time: 3 days."
16228240|NCT01175902|Drug|dorzolamide/timolol|dorzolamide/timolol fixed combination eyedrop, 2 times a day
16228241|NCT01175902|Drug|latanoprost|compare with dorzolamide/timolol fixed combination eyedrop one time a day
16228242|NCT01175889|Device|E-Z Clean ACE Blade|The prospective assessment of the E-Z Clean ACE electrosurgical electrodes using the ACE Blade in the ACE Mode for targeted procedures such as abdominoplasty, bilateral breast reduction, bilateral breast lifts, bilateral brachioplasty, bilateral lateral thigh and buttocks lifts, or any combination thereof.
16228243|NCT01175876|Device|remote limb ischemic preconditioning|Remote limb ischemic preconditioning consisted of five 5-min cycles of right upper arm ischemia/reperfusion, which was induced by an automated cuff-inflator placed on the right upper arm which was inflated to 200 mmHg for 5mins followed by deflating the cuff for 5mins
16228244|NCT01175876|Procedure|Carotid Artery Stenting|Carotid Artery Stenting is an invasive therapy of carotid stenosis.
16228245|NCT01175863|Device|Grey scale intravascular ultrasound (Galaxy or Virtual histology-Intravascular Ultrasound)|minimal lumen area on Intravascular ultrasound
16228246|NCT01175863|Device|Pressure wire(Radi Medical Systems)|Fractional flow reserve measured by pressure wire
16228247|NCT01175850|Device|Drug-Coated Balloon (DCB)|balloon dilatation and provisional stenting with IN.PACT DCB
16228248|NCT01175850|Device|PTA Balloon: Balloon Angioplasty|balloon dilatation and provisional stenting with standard non-coated PTA balloon
16228249|NCT01175837|Other|questionnaire administration|Ancillary studies: Pre- and post-fasting side effect questionnaires
16228250|NCT01175837|Other|preventative dietary intervention|24, 36, or 48 hour fast prior to chemotherapy
16228251|NCT01175837|Other|laboratory biomarker analysis|Correlative studies
16228252|NCT01175824|Drug|Insulin Lispro Low Mixture (LM)|Participant-dependent dose, administered subcutaneously for 24 weeks
16228253|NCT01175824|Drug|Insulin Glargine|Participant-dependent dose, administered subcutaneously for 24 weeks
16228254|NCT01175824|Drug|Prandial Insulin Lispro|Participant-dependent dose, administered subcutaneously for 24 weeks
16228255|NCT01175811|Drug|Insulin Lispro Premix|Participant dependent dose, administered subcutaneously for 24 weeks
16228256|NCT01175811|Drug|Insulin Glargine|Participant dependent dose, administered subcutaneously for 24 weeks
16228257|NCT01175811|Drug|Insulin Lispro|Participant dependent dose, administered subcutaneously for 24 weeks
16228258|NCT01175798|Drug|Cholecalciferol|50,000 IU PO weekly x 6 weeks
16228259|NCT01175785|Procedure|umbilical cord blood transplantation|Undergo unmanipulated umbilical cord blood transplant
16228260|NCT01175785|Drug|fludarabine phosphate|Given IV
16228261|NCT01175785|Drug|cyclophosphamide|Given IV
16228262|NCT01175785|Biological|ex vivo-expanded cord blood progenitor cell infusion|Undergo ex-vivo expanded cryopreserved cord blood progenitor cells
16228263|NCT01175785|Radiation|total-body irradiation|Undergo TBI
16228264|NCT01175785|Drug|cyclosporine|Given IV
16228265|NCT01175785|Drug|mycophenolate mofetil|Given IV and PO
16228266|NCT01175785|Other|laboratory biomarker analysis|Correlative studies
16228267|NCT01175772|Drug|Cytophosphan, Celecoxib, Methotrexate|"Metronomic Chemotherapy as maintenance treatment for patients with Ovarian Cancer
~Cytophosphan tab 50 mg -1x1 per day, continuous
~Celecoxib tab 200 mg - 1x2 per day, continuous
~Methotrexate tab 2.5 mg - 1x2 per day, 2 days weekly"
16228268|NCT01175759|Drug|Skin test panel|"Skin testing 4 sex hormones will be performed during the luteal phase of the subject's menstrual cycle by study investigators.
~Hormones:
~Progesterone 1mmol/L
~Estradiol 1mmol/L
~Estrone 3mmol/L
~Estriol 3mmol/l
~Controls:
~Saline (NaCl) 0.9%
~Ethyl Oleate with 10% Benzyl Alcohol
~Histamine phosphate 1mg/ml (epicutaneous- prick test)"
16228269|NCT01175759|Drug|Skin test panel|"Skin testing 4 sex hormones will be performed during the luteal phase of the subject's menstrual cycle by study investigators.
~Hormones:
~Progesterone 1mmol/L
~Estradiol 1mmol/L
~Estrone 3mmol/L
~Estriol 3mmol/l
~Controls:
~Saline (NaCl) 0.9%
~Ethyl Oleate with 10% Benzyl Alcohol
~Histamine phosphate 1mg/ml (epicutaneous- prick test)"
16228270|NCT01175746|Drug|Nicardipine|
16228271|NCT01175746|Drug|remifentanil|0.1-0.5 ugkg/min during hypotensive anesthesia
16228272|NCT01175733|Drug|Panitumumab|During the first 6 weeks Panitumumab will be administered weekly in combination with radiotherapy plus gemcitabine. From week 8 and further gemcitabine will be administered as monotherapy until disease progression or unacceptable toxicity, for a maximum duration of 1 year.
16228273|NCT01175720|Procedure|Periodontal surgery to gingival recessions|Test and control technique to treat gingival recessions.
16228274|NCT01175707|Drug|Daptomycin|
16228275|NCT01175707|Drug|Vancomycin|
16228276|NCT01175694|Radiation|Interstitial multicatheter brachytherapy|Interstitial PDR- and HDR-brachytherapy up to 50 Gy-eq
16228429|NCT01174550|Procedure|Exercise Electrocardiogram|Use of standard equipment for usual-care testing
16229351|NCT01167712|Drug|Paclitaxel|Given IV
16228277|NCT01175681|Procedure|remote ischaemic preconditioning|Remote ischaemic preconditioning consisted of three 5-min cycles of right upper arm ischaemia, which was induced by an automated cuff -inflator placed on the right upper arm and inflated to 200 mm Hg, with an intervening 5 min of reperfusion during which the cuff was deflated. There was a 5- to 10-min interval between completion of the remote ischaemic preconditioning protocol and initiation of bypass.Control patients had a deflated cuff placed on the right upper arm for 30 min.
16228278|NCT01175668|Drug|Clonidine|This group of infants undergoing NAS will be treated with neonatal morphine sulfate and Clonidine as an adjunct medication to control the symptoms. Once stable Finnegan scores <8 for 24h, NMS will be weaned by 10% daily till off, then Clonidine will be weaned off in a stepwise manner. Infant will not go home on any medication for NAS. NMS will be dosed as mg/kd/day divided q3h and Clonidine will be dosed as microgm/kg/day divided q6h based upon the initial Finnegan scores.
16228279|NCT01175668|Drug|Phenobarbital|"Infants in this arm will be treated as current standard practice with NMS and Phenobarbital. NMS will be weaned by 10% daily to completely off during the hospital stay. Infants will be discharged home on Phenobarbital.
~NMS will be dosed as mg/kg/day divided q3h and Phenobarbital will be dosed as mg/kg/day divided q8h based on the Finnegan scores."
16228280|NCT01175655|Other|MSC|mesenchymal stromal cells (MSC), aiming for 2 x 106 /kg cells recipient body weight, aiming for a frequency of twice weekly for two weeks
16228281|NCT01175642|Behavioral|Cognitive Remediation|Computer-based, therapist-lead cognitive remediation
16228282|NCT01175642|Behavioral|FAST|Functional adaptive skills training. Group treatment to foster the acquisition of social and adaptive skills
16228283|NCT01175616|Drug|Creatine|Oral Creatine 5 grams daily.
16228284|NCT01175603|Behavioral|Mothers and Babies Course (Adapted for Baltimore Home Visiting Programs)|6 weekly 2-hour cognitive-behavioral intervention sessions held in group format
16228285|NCT01175590|Drug|Besivance|Ocular administration to affected eye for 7 days
16228286|NCT01175590|Drug|Vehicle|Vehicle of Besivance administered to affected eye for 7 days
16228287|NCT01175577|Dietary Supplement|Chlorophyll complex, Standard Process|One capsule, twice daily with meals for 28 days
16228288|NCT01175577|Dietary Supplement|"Betatene, sold as Full Spectrum Carotenoid Complex"|One capsule per day with meals for 28 days
16228289|NCT01175577|Other|Small carotenoid-rich meals|Single carotenoid-enriched soup or salad serving eaten daily
16228290|NCT01175577|Other|Placebo|Safflower oil-filled capsules, one twice daily with meals
16228291|NCT01175564|Drug|TC-5214|Four increasing doses levels of a single dose and two increasing dose levels of 6 days repeated dose of TC-5214 tablet
16228292|NCT01175564|Drug|Placebo|Placebo tablet, single dose and 6 days repeated dose
16228293|NCT01175538|Drug|Lactulose|In the Gp-L group, patients will receive 30-60 ml of lactulose in 2 or 3 divided doses so that patient passes 2-3 semisoft stools per day
16228294|NCT01175538|Drug|Lactulose|lactulose will be used in 30-60ml/day
16228295|NCT01175525|Drug|CROMOLYN|Cromolyn 200mg (dissolved in water) given 4 times a day
16228296|NCT01175525|Drug|sugar pill|sugar pill Dissolved in water taken 4 times daily 30 minutes prior to meals
16228297|NCT01175512|Drug|Naltrexone|4 days, counterbalanced dosing of 25mg, 50mg, placebo, placebo.
16228298|NCT01175512|Drug|Placebo|4 days, counterbalanced dosing of 25mg, 50mg, placebo, placebo.
16228299|NCT01175499|Device|Direct Rigid Endoscopy|Laryngoscopy is performed under general anesthesia with a rigid laryngoscope. Mucosal surfaces of the oropharynx, hypopharynx, and glottis (base of tongue, vallecula, epiglottis, aryepiglottic folds, arytenoids, piriform sinuses, true and false vocal cords, and esophageal inlet) are systematically visualized. Areas of irregularity are biopsied with 2mm and/or 4mm cupped forceps. Esophagoscopy and bronchoscopy will be performed per the standard of care.
16228300|NCT01175499|Device|Transnasal Flexible Endoscopy with Narrowband Imaging|Transnasal flexible endoscopy with and without narrowband imaging- additional diagnostic test. This examination is performed after topical intranasal anesthesia with 2% Pontocaine spray. A fiberoptic laryngoscope is passed into the nasal cavity to the pharynx where mucosal surfaces of the UADT can be visualized. The optics of a standard fiberoptic scope are generally considered to be inferior to direct visualization. The addition of narrowband imaging does not change the procedure, but enhances visualization of the mucosal vasculature. Biopsies are performed through a second channel in the endoscope with 1.8mm cupped forceps and will require an additional dose of topical anesthesia.
16228301|NCT01175486|Drug|Actos (Pioglitazone)|Actos 30 mg for 6 months
16228302|NCT01175486|Drug|Acarbose|Acarbose 50 mg tid for 6 months
16228303|NCT01175473|Drug|Lixisenatide (AVE0010)|Self administered by subcutaneous injections once daily 30 minutes before breakfast.
16228304|NCT01175473|Device|Pen auto-injector|
16228305|NCT01175473|Drug|Liraglutide|Self administered by subcutaneous injections once daily 30 minutes before breakfast.
16228306|NCT01175473|Device|Pre-filled pen injector|
16228307|NCT01175473|Drug|Metformin|Metformin to be continued at stable dose (1.5 gram per day) up to Week 4.
16228308|NCT01175460|Drug|S-1, Nedaplatin|nedaplatin was given at a fixed dose of 75 mg/m2 on Days 1, and s-1 on Days 1-14, repeated every 4 weeks for four cycles. The dose of s-1 was initially 60 mg/m2/day and gradually increased to determine the MTD and RD of this regimen.
16228309|NCT01175447|Drug|S-1|S-1 was administered on days 1-14 and 29-42 at the following dosages: 60, 70, and 80mg/m(2)/day
16228310|NCT01175434|Other|School-Based Medication Delivery|For children assigned to the School-Based Medication group, an asthma coordinator will send the child's primary care physician a report indicating the child's asthma symptoms, and will recommend that the child receive a preventive asthma medication at school. If the child's doctor agrees, the preventive asthma medication will be delivered to the child's school and to his/her home by a local pharmacy. The child's school nurse begin directly observed therapy of the preventive asthma medication at school, and will routinely assess the child's asthma symptoms throughout the school year.
16228311|NCT01175408|Other|Remote Blood Glucose Monitoring|The subjects enrolled in the Internet Therapeutic Intervention arm receive standard care by testing their blood glucose at least 3 times daily and visit the endocrinologist every 3 months; however, they are also asked to upload their blood glucose readings online every 2 weeks for the health practitioner to view and comment upon.
16228465|NCT01174238|Drug|Paclitaxel|Day 1 of each 21 Day cycle in combination with Carboplatin if patients on on dual therapy phase.
16228312|NCT01175408|Other|Continuous Glucose Monitoring|The use of CGMS (Sensor, receiver, transmitter) (Medtronic Diabetes) plus the uploading of results to the Internet-based software utility of CareLink Personal and generating reports that can be viewed and used at the patient's own preference. This group will not receive feedback or suggestion based on the uploaded glucose data.
16228313|NCT01175408|Other|SMBG|The SMBG patients will be told that we are testing a new meter to check the accuracy of the meter. They will be asked to test at least 3 times a day and to keep a written diary of their sugar levels. The SMBG group will not know that we are counting strips and can not know about the SMBG With Knowledge group as it may bias the frequency that they test.
16228314|NCT01175408|Other|SMBG With Knowledge|The SMBG With Knowledge patients will be given a new meter and will be asked to test at least 3 times a day and to keep a written diary of their sugar levels. We will inform this group that we are measuring the frequency of SMBG testing.
16228315|NCT01175395|Drug|IBI-20089/Lucentis|Combining a single dose of IBI-20089 (6.9 mg or 13.8 mg) intravitreal injection adjunctively with Lucentis 0.5 mg intravitreal injection at baseline and monthly intravitreal Lucentis injection PRN based on clinical and OCT results.
16228316|NCT01175382|Behavioral|Behavioral training|Behavioral treatment consists of skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, urge suppression techniques, delayed voiding, and daily bladder diaries to track increasing voiding intervals and enhance awareness of bladder habits. Training is supplemented with instructions for daily home practice between clinic visits. In addition to daytime training, nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies.
16228317|NCT01175382|Drug|Tolterodine + tamsulosin|Patients in drug therapy receive an anti-muscarinic (long acting tolterodine 4 mg daily) and an alpha blocker (tamsulosin 0.4 mg daily).
16228318|NCT01175382|Other|Combined Behavioral + Drug Therapy|Combined behavioral and drug therapy implemented in 4 clinic visits over a period of 6 weeks, followed by an additional 6 weeks of combined therapy. Behavioral treatment consists of behavioral training and includes skills and strategies for postponing urination, controlling urgency and preventing urge incontinence. This includes pelvic floor muscle training, incremental delayed voiding, and bladder diaries, supplemented with instructions for daily home practice. Nocturia is managed with fluid restriction (3 hours before bedtime and during the night) and with urge strategies. Drug therapy consists of an anti-muscarinic (sustained release tolterodine 4 mg) + an alpha blocker (tamsulosin 0.4mg daily).
16228319|NCT01175369|Behavioral|School-based Care|The intervention includes directly observed administration of preventive medications in school and a home-based ETS reduction program (for those living with one or more smokers).
16228320|NCT01175356|Drug|cyclophosphamide|Given IV
16228321|NCT01175356|Drug|topotecan hydrochloride|Given IV
16228322|NCT01175356|Drug|cisplatin|Given IV
16228323|NCT01175356|Drug|etoposide phosphate|Given IV
16228324|NCT01175356|Drug|vincristine sulfate|Given IV
16228325|NCT01175356|Drug|doxorubicin hydrochloride|Given IV
16228326|NCT01175356|Radiation|iobenguane I 131|Given IV
16228327|NCT01175356|Procedure|therapeutic conventional surgery|Undergo surgery
16228328|NCT01175356|Drug|busulfan|Given IV
16228329|NCT01175356|Drug|melphalan|Given IV
16228330|NCT01175356|Procedure|autologous hematopoietic stem cell transplantation|Undergo autologous in vitro-treated peripheral blood stem cell transplantation
16228331|NCT01175356|Procedure|in vitro-treated peripheral blood stem cell transplantation|Undergo autologous in vitro-treated peripheral blood stem cell transplantation
16228332|NCT01175356|Radiation|3-dimensional conformal radiation therapy|Undergo radiotherapy
16228333|NCT01175356|Radiation|external beam radiation therapy|Undergo radiotherapy
16228334|NCT01175356|Radiation|intensity-modulated radiation therapy|Undergo radiotherapy
16228335|NCT01175356|Drug|isotretinoin|Given PO
16228336|NCT01175356|Other|pharmacological study|Correlative studies
16228337|NCT01175356|Other|questionnaire administration|Ancillary studies
16228338|NCT01175356|Other|laboratory biomarker analysis|Correlative studies
16228339|NCT01175343|Drug|Gamma-Secretase Inhibitor RO4929097|Given PO
16228340|NCT01175343|Other|Laboratory Biomarker Analysis|Correlative studies
16228341|NCT01175330|Drug|Omega-3 fish oil emulsion (Omegaven)|Lipid emulsion (omegaven) for intravenous use, 1 ml/kg/day daily for 7 days post-surgery period (The first infusion beginning in operative period)
16228342|NCT01175330|Drug|Intralipid|Lipid emulsion (Intralipid) for intravenous use, 1 ml/kg/day daily for 7 days post-surgery period (The first infusion beginning in operative period)
16228343|NCT01175317|Procedure|Goal-directed fluid optimization|Fluid administration and optimization based on cardiac output findings during surgery and during the first 8 hours of the postoperative phase.
16228344|NCT01175317|Other|Regimen based on expertise anaesthesist|Fluid regimen based on expertise anaesthesist
16228345|NCT01175291|Drug|MK-0646|ARM A will receive FOLFOX 7 (Oxaliplatin with leucovorin + 5-Fluorouracil [5-FU] + Bevacizumab) + MK-0646 (Investigational).
16228346|NCT01175291|Drug|Placebo|ARM B will receive FOLFOX 7 (Oxaliplatin with leucovorin + 5-Fluorouracil [5-FU] + Bevacizumab) + placebo: standard of care chemotherapy plus placebo.
16228347|NCT01175278|Procedure|Vertebral Augmentation with Balloon Kyphoplasty|Two small metal tubes will be inserted through the skin into the collapsed bone. Inflatable bone tamps (balloon catheters) will be inserted through each of these two tubes into the bone. The balloons will be inflated with a liquid that can be seen on xrays (contrast) to return the bone toward its natural shape and create a cavity. The balloons will then be deflated and removed. The cavity in the bone will be filled with bone cement to stabilize the broken backbone.
16228348|NCT01175278|Other|Non-surgical Treatment|Non-surgical treatment means the institution of therapies other than cancer chemotherapy and surgical treatment aimed at alleviation of back pain and restoration of decreased function associated with the patient's VCF(s).
16228430|NCT01174537|Biological|New Castle Disease Virus|Patients will receive IV 1*10^10 EID50 (50 percent Embryo Infectious Dose. One EID50 unit is the amount of virus that will infect 50 percent of inoculated eggs) on a daily basis for a minimum of 5 days a week until disease progression for a minimum duration of 1 year.
16228431|NCT01174524|Drug|gestoden 60 mcg|gestoden 60 mcg, once a day, administered in 24/4 regimen.
16228349|NCT01175265|Other|respiratory biofeedback|In order to train effortless diaphragmatic breathing techniques the biofeedback loop starts at the sensor that measures the patient's breathing rhythm at both umbilical and abdominal level. The sensor is connected to an amplifier that converts the electrical impulses into acoustical and visual outputs. Patients were encouraged to regulate their breathing patterns at a 10-20% slower respiration rate resulting in increased tidal volumes. Furthermore, the patients were encouraged to reduce dynamic hyperinflation by completing the expiration prior to the initiation of the next breath while using pursed-lips breathing. Patients were trained to breath as comfortable as possible with predominant abdominal expansion during the inhalation and smooth abdominal contraction during exhalation.
16228350|NCT01175252|Other|Database analysis|Review and collect data from database
16228351|NCT01175239|Genetic|Single infusion of autologous CD34+ cells transduced with the self-inactivating (SIN) gammaretroviral vector pSRS11.EFS.IL2RG.pre|Single infusion of autologous CD34+ cells transduced with the self-inactivating (SIN) gammaretroviral vector pSRS11.EFS.IL2RG.pre
16228352|NCT01175226|Drug|BTA798|BTA798 twice daily
16228353|NCT01175226|Drug|Placebo|Placebo twice daily
16228354|NCT01175213|Biological|SC treatment with IGSC, 10% with rHuPH20 followed by SC/IGSC, 10% only (safety)|"Participants are to continue on the same doses and treatment intervals of IGSC, 10% adjusted for body weight, and rHuPH20 that were used for the last infusions in Study epoch 2 of Study 160603 (NCT00814320).
~After 3 infusions, participants are to change treatment to a 2-week interval, if agreed with participant and investigator.
~During this safety follow-up period, participants are treated with IGSC, 10% via the SC route. Treatment occurred once every week. The dose was the weekly equivalent of the most recent IV dose (adjusted per body weight) and multiplied by 1.37."
16228355|NCT01175213|Biological|SC treatment with IGSC, 10% with rHuPH20 followed by IV/IGSC, 10% only (safety)|"Participants are to continue on the same doses and treatment intervals of IGSC, 10% adjusted for body weight, and rHuPH20 that were used for the last infusions in Study epoch 2 of Study 160603 (NCT00814320).
~After 3 infusions, participants are to change treatment to a 2-week interval, if agreed with participant and investigator.
~During this safety follow-up period, participants are treated with IGSC, 10% via the intravenous (IV) route. Treatment occurred once every 3-4 weeks. The weekly dose equivalent was 100% of the most recent IV dose."
16228356|NCT01175213|Biological|IV treatment with IGSC, 10%|During this safety follow-up period, participants are treated with IGSC, 10% via the intravenous (IV) route.
16228357|NCT01175200|Drug|Clopidogrel|antiplatelet agent
16228358|NCT01175200|Drug|Prasugrel|antiplatelet agent
16228359|NCT01175200|Drug|Lansoprazole|proton pum inhibitor
16228360|NCT01175200|Drug|Placebo|placebo comparator similar to lansoprazole
16228361|NCT01175161|Device|Copper T380A Intrauterine Device|the Copper T380A IUD will be placed either 10 minutes to 48 hours postpartum, or 4-6 weeks postpartum.
16228362|NCT01175148|Drug|Atorvastatin calcium (Lipitor)|40 mg PO daily
16228363|NCT01175135|Drug|PF-02545920|5 mg tablet every 12 hours for 28 days
16228364|NCT01175135|Drug|PF-02545920|15 mg tablet every 12 hours for 28 days
16228365|NCT01175135|Drug|Placebo|One tablet/capsule every 12 hours for 28 days
16228366|NCT01175135|Drug|Risperidone|3 mg capsule every 12 hours for 28 days
16228367|NCT01175122|Biological|H2N3 MO 2003/AA ca Vaccine|0.2 mL of H2N3 MO 2003/AA ca vaccine delivered by an Accuspray nasal spray device on Day 0 and Day 28
16228368|NCT01175109|Drug|Imatinib + LBH589|Escalating doses of imatinib and LBH589 will be administered.
16228369|NCT01175096|Drug|RAD001 (everolimus, Afinitor®)|"RAD001 will be provided by Novartis to the study sites. RAD001 is formulated as tablets of 5 mg strength, blister-packed under aluminum foil in units of 30 tablets. The study site will dispense an adequate supply of RAD001 to the patient for self-administration at home.
~2 x 5 mg (=10 mg) RAD001 p.o., once daily, at the same time each day, One treatment cycle consists of 28 days."
16228370|NCT01175083|Biological|GSK1024850A (Synflorix)|2, 3 or 4 intramuscular injection
16228371|NCT01175083|Biological|Tritanrix-HepB/Hib|Intramuscular injection, 4 doses
16228372|NCT01175083|Biological|Polio Sabin|4 oral doses
16228373|NCT01175070|Drug|Intravitreal injection of pegaptanib sodium|Eligible participants with ischaemic diabetic macular oedema will receive an intravitreal injection of pegaptanib sodium (Macugen [TM]) 0.3mg every 6 weeks over a 30 week period.
16228374|NCT01175044|Procedure|Betadine Lavage|Following revision knee surgery, a dilute betadine lavage prior to surgical closure for 3 minutes followed by 2000 ml of sterile saline irrigation
16228375|NCT01175044|Procedure|Saline Lavage|Following revision knee surgery, 2000ml sterile saline lavage prior to closure
16228376|NCT01175031|Other|Manipulation of Positive Airway Pressure (PAP)|Positive airway pressure (PAP) will be manipulated throughout the night to induce breathing events. PAP will be set to the participant's prescribed pressure, increased until breathing events are induced , and then returned to the prescribed pressure. This cyclic pattern will continue throughout the night.
16228377|NCT01175018|Drug|Anakinra|Anakinra 100 mg s.c. daily for 14 days
16228378|NCT01175018|Drug|Placebo|0.67 ml of NaCl 0.9% solution given subcutaneously daily for 14 days
16228379|NCT01174992|Biological|Evicel|EVICEL is a human plasma derived fibrin sealant
16228380|NCT01174992|Other|Sutures only|Standard of care
16228381|NCT01174979|Drug|Caroverin|treatment with eardrops 2 times for 48 hours
16228382|NCT01174953|Drug|finasteride|"Finasteride 5 mg once daily
~Soy 4 capsules twice daily (160 mg total)"
16228383|NCT01174940|Drug|extracorporeal photopheresis|"Patients will receive 2 ECP treatments prior to the commencement of the high dose chemotherapy and then for two consecutive days every two weeks starting from post engraftment (ANC > 500) up to day 90 (total of 10 treatments). This may be given as an outpatient procedure.
~The dose of UVADEX® used to inoculate these cells will be calculated based on the treatment volume collected during the plasma/buffy coat collection process, using the following formula:
~Treatment Volume in mL X 0.017 of UVADEX® (20 mcg/ml) required for administration into the recirculation bag = Amount of UVADEX® (in mLs) required for administration into the recirculation bag.
~After the cells are inoculated with UVADEX®, the buffy coat/plasma suspension is irradiated with ultraviolet-A light and then re-infused back into the patient."
16228432|NCT01174524|Drug|ethinylestradiol 15 mcg|ethinylestradiol 15 mcg, once a day, administered in 24/4 regimen
16228682|NCT01172756|Drug|Riociguat (BAY63-2521)|1 mg single oral dose
16228384|NCT01174927|Drug|diacetylmorphine (DAM)|The heroin-dependent patients will administer either their individual dose of prescribed DAM dose or placebo (saline) through an indwelling intravenous line. Afterwards they will complete four experimental paradigms testing response inhibition, emotional processing and working memory while brain responses are measured with fMRI. Before and after the fMRI investigation cortisol samples, DAM blood levels, neurophysiological and psychological stress parameters, such as skin conductance, heart rate, anxiety, anger, and heroin craving will be measured.
16228385|NCT01174927|Other|Placebo|Saline
16228386|NCT01174914|Other|ARV's + Placebo|Patients continued ARV's plus a placebo nightly for 9 months
16228387|NCT01174914|Drug|Naltrexone|Naltrexone, Low-Dose (3mg) given once daily at bedtime for 9 months
16228388|NCT01174914|Drug|Naltrexone + ARV's|Patients were given standard ARV's plus Naltrexone (Low Dose) 3mg nightly.
16228389|NCT01174888|Drug|midostaurin|Drug midostaurin, Given orally given twice daily days 1-14
16228390|NCT01174888|Drug|Bortezomib|Bortezomib given IV on days 1, 4, 8, and 11
16228391|NCT01174888|Drug|mitoxantrone hydrochloride|Patients receive mitoxantrone hydrochloride IV over 10 minutes
16228392|NCT01174888|Drug|etoposide|Patients receive etoposide IV over 1 hour
16228393|NCT01174888|Drug|cytarabine|Patients receive cytarabine IV over 6 hours on days 1-6
16228394|NCT01174849|Drug|Synflorix|The 10-valent vaccine contains 1 µg of purified capsular polysaccharide of pneumococcal serotypes 1, 5, 6B, 7F, 9V, 14, and 23F conjugated to protein D, 3 µg of serotype 4 conjugated to protein D, 3 µg of serotype 18C conjugated to tetanus toxoid and 3 µg of serotype 19F conjugated to diphtheria toxoid.
16228395|NCT01174849|Drug|Prevenar13|"The vaccine is a ready to use homogeneous white suspension for intramuscular injection, supplied as a pre-filled syringe.
~Active ingredients
~Each 0.5 mL dose contains:
~2.2 μg of pneumococcal purified capsular polysaccharides for serotypes 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F and 23F 4.4 μg of pneumococcal purified capsular polysaccharides for serotype 6B. Each serotype is individually conjugated to non-toxic diphtheria CRM197 protein and adsorbed on aluminium phosphate (0.565 mg). CRM197 is a nontoxic variant of diphtheria toxin isolated from cultures of Corynebacterium diphtheriae strain C7 (β197) grown in a casamino acids and yeast extract-based medium."
16228396|NCT01174849|Drug|COMBO|COMBINATION SCHEDULE of vaccine 1 and vaccine 2: Synflorix (PHiD-CV) at 1,2,4 months then Prevenar13 (PCV13) at 6 months of age.
16228397|NCT01174836|Other|Educational session|Physicians will have a brief education session provided in powerpoint about the risks of CT
16228398|NCT01174823|Drug|bepotastine besilate ophthalmic solution|sterile ophthalmic solution
16228399|NCT01174823|Drug|placebo comparator ophthalmic solution|sterile ophthalmic solution
16228400|NCT01174810|Drug|Exenatide|Exenatide, 5 micrograms twice a day for 1 month and 10 micrograms twice a day for 11 months. Total duration of treatment 12 months
16228401|NCT01174784|Device|Chronic TOtAl OcclusioN CrossiNg with thE WildCat CatheTer|A Non-Randomized Study of the Avinger Wildcat™ used to Cross Chronic Total Occlusions in the Superficial Femoral and Popliteal Arteries
16228402|NCT01174732|Drug|albuterol inhalation powder|A006 albuterol inhalation powder, 120 mcg/inhalation, one inhalation
16228403|NCT01174732|Drug|albuterol inhalation powder|A006 albuterol inhalation powder, 180 mcg/inhalation, 1 inhalation
16228404|NCT01174732|Drug|albuterol inhalation powder|A006 albuterol inhalation powder, 120 mcg/inhalation, 2 inhalations
16228405|NCT01174732|Drug|albuterol inhalation powder|A006 albuterol inhalation powder, 180 mcg/inhalation, 2 inhalations
16228406|NCT01174732|Drug|Placebo|placebo, lactose inhalation carrier
16228407|NCT01174732|Drug|albuterol inhalation aerosol|albuterol inhalation aerosol, 90 mcg/inhalation, 2 inhalations
16228408|NCT01174732|Drug|albuterol inhalation aerosol|albuterol inhalation aerosol, 90 mcg/inhalation, 4 inhalations
16228409|NCT01174719|Drug|volume replacement|Hydroxyethylstarch up to 50mL/kg/24 hrs
16228410|NCT01174719|Drug|Humanalbumin 5%|Humanalbumin 5% up to 50 mL/kg/24 hours
16228411|NCT01174719|Drug|volume replacement|up 10 50mL/kg/24 hours
16228412|NCT01174706|Behavioral|Information prescriptions|One arm will receive usual care at discharge. The other three arms will receive practical assistance and/or an information prescription which will consist of written information from Medline Plus and access to a clinical informationist if subject has additional information needs.
16228413|NCT01174693|Drug|Triflusal|Dose: 150mg or 300mg capsule, 300mg bid, Mode of administration: oral, Duration: from randomization to 31 December 2014
16228414|NCT01174693|Drug|Clopidogrel|Dose: 75mg tablet, 75mg once daily, Mode of administration: oral, Duration: from randomization to 31 December 2014
16228415|NCT01174680|Procedure|cardiogoniometry|In the course of the project a cardiogoniometry will be carried out during the ambulant or residential hospitalization before the coronary angiography.
16228416|NCT01174667|Procedure|Specific massage for fascial release|Patient will receive a 3 minute massage to reduce restrictions in the lumbodorsal fascia.
16228417|NCT01174667|Other|Quiet non-instructed rest for 3 minutes|Patient will lay quietly without any instructions on how to relax.
16228418|NCT01174654|Behavioral|Contingency management|A 12-week contingency management intervention
16228419|NCT01174641|Other|trans-cranial magnetic stimulation|1 Hz trans-cranial magnetic stimulation will be applied for 20min at 60% motor threshold over the vertex
16228420|NCT01174641|Other|trans-cranial magnetic stimulation|trans-cranial magnetic stimulation will be applied at 1Hz for 20 min over the ipsilesional posterior parietal cortex of stroke patients with unilateral neglect
16228421|NCT01174602|Behavioral|Exposure Therapy for AN (AN-EX/RP)|12 Sessions, 3 times per week. 90 minute sessions. Group therapy twice per week.
16228422|NCT01174602|Behavioral|Cognitive Remediation Therapy|12 Sessions, 3 times per week. 45 minute sessions. Group therapy twice per week.
16228423|NCT01174589|Other|Strength training|to compare if there is a difference between 6 or 12 weeks of physical strength training
16228424|NCT01174576|Other|caffeinated and decaffeinated coffee|3 treatments on separate days, i.e. a standard breakfast with oral ingestion of 200 ml of either caffeinated coffee (3mg caffeine/kg body weight), decaffeinated coffee or water
16228425|NCT01174563|Drug|erlotinib [Tarceva]|150 mg orally daily, with dose-reductions to 100 mg or 50 mg orally daily according to protocol
16228426|NCT01174550|Procedure|Coronary Angiography|Use of standard equipment for usual-care testing
16228433|NCT01174511|Drug|A -1 Cool Cream,Vaselin ointment|A- 1 Cool Cream applied to flexural aspects of the upper and lower limb on the one site of patient and placebo (Vaseline ointment) applied to other site of the upper and lower limb in the itch patient. Applying the ointment will be a regular time, twice a day for 5 consecutive days
16228434|NCT01174498|Device|Cerbomed t-VNS® transcutaneous stimulation|Subjects experience a transcutaneous, electrical, vagal stimulation with the t-VNS device.
16228435|NCT01174498|Device|t-VNS Sham stimulation|t-VNS Sham stimulation
16228436|NCT01174485|Procedure|exercise|combined resistance and aerobic training
16228437|NCT01174472|Device|Percutaneous Transluminal Angioplasty (PTA)|Angioplasty performed with the use of the novel paclitaxel eluting balloons
16228438|NCT01174472|Device|Percutaneous Transluminal Angioplasty (PTA)|Angioplasty performed with the use of conventional angioplasty balloons
16228439|NCT01174446|Biological|BAX 326|"Study Part 1: Pharmacokinetic (PK) Crossover with BAX326 and BeneFIX
~Study Part 2: Open-label evaluation of prophylaxis and on-demand BAX326 only
~Study Part 3: Open-label repeat of PK evaluation (repeat Study Part 1) with BAX326 only and same study participants as Study Part 1"
16228440|NCT01174446|Biological|BeneFIX|"Study Part 1: Pharmacokinetic (PK) Crossover with BAX326 and BeneFIX.
~BeneFIX only used in Part 1 of this study.
~Study Part 2 and 3 only utilized BAX326"
16228441|NCT01174433|Device|Tryton|Percutaneous coronary intervention of a bifurcation lesion, with a Tryton bifurcation coronary stent for the side branch and a drug-eluting coronary stent for the main branch
16228442|NCT01174420|Device|Use of ologen Collagen Matrix in trabeculectomy|After trabeculectomy, place ologen Collagen Matrix on the top of the scleral flap under the conjunctiva before suturing
16228443|NCT01174420|Drug|Use of Mitomycin-C in trabeculectomy|After creating a scleral flap, a sponge with Mitomycin-C (0.02%) is applied on the scleral surface for 3 minutes. Afterwards, Mitomycin-C was rinsed out with balanced salt solution.
16228444|NCT01174407|Other|cd 35, cd21, cd55|Blood drawing/ 10ml/ once- duration of 1 day of full examination of the patient
16228445|NCT01174394|Procedure|DCEAS (Hwato®/ Dongbang®)|Upon insertion of acupuncture needles, dense cranial electro-acupuncture stimulation (DCEAS), is directly delivered on a density of cranial acupoints (in general 6-8 pairs) located on the frontal, parietal, and temporal scalp areas.
16228446|NCT01174394|Procedure|Body electro-acupuncture (Hwato®/ Dongbang®)|Both study arms received body electroacupuncture on both sides of ipsilateral limb pairs: Hegu (LI4) and Quchi (LI11) , Zusanli (ST36) and Taichong (LR3). Electrical stimulation as DCEAS is applied.
16228447|NCT01174394|Procedure|n-CEA (Strietberger®)|Streitberger's non-invasive acupuncture needles were applied to serve as sham control at the same cranial acupoints and the same stimulation modality, except that the needles only adhere to the skin instead of insertion
16228448|NCT01174394|Drug|Fluoxetine|Subjects of both study arms received orally administered SSRIs for 4 weeks in an open manner. For those who were currently under antidepressant treatment, they would continue the existing treatment regimens. For those who were not medicated at the time of trial, fluoxetine (FLX) was given at an initiate dose of 10 mg/day and escalated to an optimal dose within one week, based on individual response, but the maximum dose was set at 40 mg/day.
16228449|NCT01174381|Behavioral|lifestyle modification|Lifestyle modification for six months
16228450|NCT01174368|Biological|Cancer Macrobead placement in abdominal cavity|8 macrobeads per kilogram
16228451|NCT01174355|Drug|ND0801|Confidential
16228452|NCT01174329|Device|"Automatic neuro-electrostimulation by Saliwell Crown"|"Continuous stimulation of the lingual nerve by Saliwell Crown"
16228453|NCT01174329|Device|"Patient-regulated neuro-electrostimulation by Saliwell Crown"|"On-demand stimulation of the lingual nerveby Saliwell Crown"
16228454|NCT01174316|Device|AutoVPAP™|Automatically titrated non-invasive ventilator, with target gross alveolar ventilation, end expiratory positive pressure, and back up respiratory rate determined by the clinician based on height and weight. The NIV must be used for as many hours as possible over the 24 hour period but breaks for meals, physiotherapy and bathroom are allowed.
16228455|NCT01174316|Device|VPAPIIIST-A™|Standard non-invasive ventilator, with inspiratory and expiratory positive pressure determined by the healthcare professional. The NIV must be used for as many hours as possible over the 24 hour period but breaks for meals, physiotherapy and bathroom are allowed.
16228456|NCT01174303|Drug|insulin degludec/insulin aspart|Each subject will be randomly allocated to two single doses injected subcutaneously (under the skin) of insulin degludec/insulin aspart and biphasic insulin aspart 30 in random order.
16228457|NCT01174303|Drug|biphasic insulin aspart 30|Each subject will be randomly allocated to two single doses injected subcutaneously (under the skin) of insulin degludec/insulin aspart and biphasic insulin aspart 30 in random order.
16228458|NCT01174290|Drug|Haloperidol decanoate|"IV q6h.
~Study drug will be continued until one of the following study withdrawal/termination criteria is met:
~Delirium (ICDSC ≥ 4) develops. The diagnosis of delirium will be confirmed in all instances by the Psychiatric Consultation Service, Division of Psychiatry, Tufts Medical Center using DSM-IV criteria.
~The patient is discharged from the ICU at Tufts MC.
~10 days of study drug administration occurs.
~The subject experiences an adverse event potentially attributable to the study drug that is deemed, in the opinion of one of the physicians on the study team or the MICU team, to warrant discontinuation of therapy."
16228459|NCT01174290|Drug|Placebo|"D5W 0.2mL IV q6h
~Study drug will be continued until one of the following study withdrawal/termination criteria is met:
~Delirium (ICDSC ≥ 4) develops. The diagnosis of delirium will be confirmed in all instances by the Psychiatric Consultation Service, Division of Psychiatry, Tufts Medical Center using DSM-IV criteria.
~The patient is discharged from the ICU at Tufts MC.
~10 days of study drug administration occurs.
~The subject experiences an adverse event potentially attributable to the study drug that is deemed, in the opinion of one of the physicians on the study team or the MICU team, to warrant discontinuation of therapy."
16228460|NCT01174277|Other|Collection of blood sample|Participation involves collection of blood sample at baseline, 2, 4, 6 and 12 months regardless of whether or not patients continue on treatment.
16228461|NCT01174264|Other|Pharmacological Study|Correlative studies
16228462|NCT01174264|Drug|Vismodegib|Given PO
16228463|NCT01174238|Drug|Axitinib|5mg BID Axitinib Days 1-14 for dual therapy - 5mg BID QD for patients on monotherapy
16228464|NCT01174238|Drug|Carboplatin|Day 1 of each 21 day cycle in combination with paclitaxel if patients are in dual therapy phase
16228466|NCT01174225|Device|Flexi T 380(+) IUD|The intrauterine device is placed in the uterus immediately post-abortion. Participant is counseled that she may leave the device in for up to five years.
16228467|NCT01174225|Device|Nova T IUD|The intrauterine device is placed in the uterus immediately post-abortion. Participant is counseled that she may leave the device in for up to five years.
16228468|NCT01174212|Procedure|Prophylactic Antibiotics|Preoperative Antibiotics
16228469|NCT01174212|Procedure|Control Antibiotics|Antibiotics will be held until intraoperative cultures have been obtained.
16228470|NCT01174199|Drug|vorinostat|Given orally
16228471|NCT01174199|Drug|temsirolimus|Given IV
16228472|NCT01174199|Other|laboratory biomarker analysis|Correlative study
16228473|NCT01174199|Procedure|positron emission tomography/computed tomography|PET scan
16228474|NCT01174186|Drug|Adalimumab|Tumor Necrosis Factor (TNF) alpha inhibitor given 40 mg subcutaneously every other week except the first time where 80 mg is given
16228475|NCT01174173|Drug|Ranolazine|ranolazine 1000 mg PO BID for 3 months
16228476|NCT01174160|Drug|vernakalant hydrochloride|Patients will receive a 3 mg/kg infusion of vernakalant hydrochloride. If the patient is in atrial fibrillation (AF) or atrial flutter (AFL) 25 minutes after the start of the infusion, then a second infusion of 2 mg/kg vernakalant hydrochloride will be administered.
16228477|NCT01174160|Drug|Placebo to vernakalent hydrochloride|Patients will receive an infusion of placebo. If the patient is in atrial fibrillation (AF) or atrial flutter (AFL) 25 minutes after the start of the infusion, then a second infusion of placebo will be administered.
16228478|NCT01174134|Other|Nutritional beverage|
16228486|NCT01174082|Biological|KLH Vaccine|"Donor: 0.5 cc subcutaneously, 3 times on weeks -8, -6 and -2 prior to lymphocyte collection.
~Patient: 0.5 cc subcutaneously, 3 times immediately after infusion of donor cells (DLI), and again 4 and 8 weeks post DLI."
16228487|NCT01174082|Biological|KLH-id Vaccine|"Donor: 0.5 cc subcutaneously, 3 times on weeks -8, -6 and -2 prior to donor lymphocyte collection.
~Patient: 0.5 cc subcutaneously, 3 times immediately after infusion of donor cells (DLI), and again 4 and 8 weeks post DLI."
16228488|NCT01174082|Drug|GM-CSF|250 mcg/m2 subcutaneously daily for 4 days after each vaccine
16228489|NCT01174082|Procedure|Apheresis|Day 0 (day of lymphocyte collection) donors undergo a steady state pheresis to obtain lymphocytes.
16228490|NCT01174082|Procedure|Donor Lymphocyte Infusion (DLI)|Day 0, infusion to patient of collected donor cells.
16228491|NCT01174069|Procedure|NOTES assisted laparoscopic cholecystectomy|Surgical removal of the gallbladder using endoscopic instruments.
16228492|NCT01174056|Drug|Zileuton|600 mg tablets po QID for 5 days prior to endotoxin, stopping 24 hours after endotoxin instillation
16228493|NCT01174056|Drug|Pioglitazone placebo|Lactose filled gelatin capsule, size 00, 1 tablet po bid x 2 weeks prior to endotoxin instillation until 24 hours after endotoxin.
16228494|NCT01174056|Drug|Zileuton placebo|Placebo tablets provided by manufacturer of Zyflo CR (Cornerstone Therapeutics), 2 tablets po bid x 5 days prior to endotoxin instillation until 24 hours after endotoxin.
16228495|NCT01174056|Drug|Pioglitazone|PPAR-gamma agonist
16228496|NCT01174043|Drug|Erlotinib|Erlotinib will be administered orally at 150 mg once a day, continuously. Each cycle will be 28 days and there will be no break between the cycles.
16228497|NCT01174030|Drug|CD07805/47 Gel|CD07805/47 Gel 0.5% QD
16228498|NCT01174030|Drug|Vehicle Gel|Vehicle Gel QD
16228499|NCT01174030|Drug|CD07805/47 Gel|CD07805/47 Gel 0.18% QD
16228500|NCT01174030|Drug|CD07805/47 Gel|CD07805/47 Gel 0.18% BID
16228501|NCT01174030|Drug|Vehicle Gel|Vehicle Gel BID
16228502|NCT01174017|Radiation|Iodine 125 standard loose brachytherapy seeds|radioactivity 0.4 U per seed, prescribed dose 144 Gy
16228503|NCT01174017|Radiation|AnchorSeed Iodine 125 brachytherapy prostate implant|activity 0.4 U per seed, prescribed dose 144 Gy
16228504|NCT01174004|Drug|pimavanserin tartrate|pimavanserin tartrate, 40 mg, tablet, once daily by mouth for 6 weeks
16228505|NCT01174004|Drug|placebo|placebo, tablet, once daily by mouth for 6 weeks
16228506|NCT01173991|Behavioral|Carbohydrate counting training|Carbohydrate counting was taught during 4-5 individual sessions with a dietician and a diabetologist.
16228507|NCT01173978|Behavioral|Steroid hormone|Steroid hormone: 37,5 mg of prednisolone; High energy diet: 130 % of recommended daily energy intake; Relative physical inactivity: no exercise and at least 8 hours of rest/day
16228508|NCT01173978|Other|No intervention|
16228509|NCT01173965|Device|MEA|Microwave endometrial ablation device
16228510|NCT01173965|Device|Novasure|Bipolar impedence control system
16228511|NCT01173939|Drug|Pravastatin|5 mg/day or 10 mg/day of pravastatin will be administered orally for 36 months, with a follow-up period of one month. If the target LDL-C level is not attained after one month of treatment, the steps will be taken to reduce the LDL-C to the target level of <120 mg/dL (JASGL 2007 target level) as quickly as possible. (Maximum dose increase of pravastatin: 20 mg/day)
16228683|NCT01172756|Drug|Riociguat (BAY63-2521)|2 mg single oral dose
16228684|NCT01172756|Drug|Placebo|single oral dose
16228512|NCT01173939|Drug|Rosuvastatin|5 mg/day or 10 mg/day of rosuvastatin will be administered orally for 36 months based on the LDL-C level of the subject, with a follow-up period of one month. If the target LDL-C level is not attained after one month of treatment, the steps will be taken to reduce the LDL-C to the target level of <70 mg/dL as quickly as possible. (Maximum dose increase to rosuvastatin: 20 mg/day)
16228513|NCT01173926|Drug|insulin degludec|Each trial participant will receive one single dose of each trial product in varying order (NN5401, NN1250 and insulin aspart) on 3 separate dosing visits. The trial products will be administered subcutaneously (under the skin).
16228514|NCT01173926|Drug|insulin degludec/insulin aspart|Each trial participant will receive one single dose of each trial product in varying order (NN5401, NN1250 and insulin aspart) on 3 separate dosing visits. The trial products will be administered subcutaneously (under the skin).
16228515|NCT01173926|Drug|insulin aspart|Each trial participant will receive one single dose of each trial product in varying order (NN5401, NN1250 and insulin aspart) on 3 separate dosing visits. The trial products will be administered subcutaneously (under the skin).
16228516|NCT01173913|Drug|ModraDoc001 10mg capsules|Bi-daily administration. One cycle will last 7 days
16228517|NCT01173913|Drug|ModraDoc003 10mg tablets and ModraDoc004 10/50 mg|The patients will receive 40 mg docetaxel and 200 mg ritonavir once daily as different dosage forms (ModraDoc001 10 mg capsules, ModraDoc003 10 mg tablets and ModraDoc004 10/50 mg tablets). Patients continue in Week 4 with 80 mg docetaxel (as ModraDoc001 10 mg capsules) in combination with 100 mg ritonavir once daily in a weekly schedule until progressive disease or adverse events, which require dose modifications or discontinuation of therapy, are observed.
16228518|NCT01173913|Drug|ModraDoc006 10 mg tablet|Bi-daily administration. One cycle will last 7 days
16228519|NCT01173900|Biological|Gardasil® HPV vaccine|0.5 ml given at 0, 2, 6 months
16228520|NCT01173887|Drug|VCAP/AMP/VECP(mLSG15)|VCAP(Vincristine Sulfate, Cyclophosphamide Hydrate, Doxorubicin Hydrochloride, Prednisolone); AMP(Doxorubicin Hydrochloride, Ranimustine, Prednisolone); VECP(Vindesine Sulfate, Etoposide, Carboplatin, Prednisolone)
16228521|NCT01173887|Biological|KW-0761|VCAP/AMP/VECP(mLSG15) + KW-0761
16228522|NCT01173874|Drug|Cognitive Remediation|Cognitive remediation intervention will be administered in small group settings twice weekly for 30 sessions and will utilize computerized and verbal group training exercises to address basic skills such as auditory processing, attention, processing speed, and verbal working memory and learning, as well as intermediate and complex skills such as deductive reasoning, planning and sequencing, set shifting, and complex problem solving.
16228523|NCT01173861|Behavioral|Physical activity counseling|20-30 minutes of face-to-face physical activity counseling using motivational interviewing followed by 3 20 minute telephone counseling sessions.
16228524|NCT01173848|Drug|Ergocalciferol|1.25mg weekly for 12 weeks then once a month for 3 months. or 1.25 weekly for 4 weeks then once a month for 5 months. or 1.25 monthly for 6 months
16228525|NCT01173848|Drug|Cholecalciferol|1.25 weekly for 12 weeks then monthly for 3 months or 1.25 weekly for 4 weeks then monthly for 5 months or 1.25 monthly for 6 months
16228526|NCT01173835|Behavioral|Incentives for being tobacco free|Students who join the program will be entered into regularly scheduled drawings throughout the school year to earn incentives for being tobacco free.
16228527|NCT01173822|Other|Ultrafiltration of residual blood|The inflow line to the hemoconcentrator was connected to the sideport of the arterial filter stopcock, allowing the residual blood in the CPB circuit to be processed through the hemoconcentrator. The outflow line from the hemoconcentrator was connected to a second three way stopcock located on the cardiotomy reservoir. Blood was circulated from the venous reservoir through the hemoconcentrator and returned to the venous reservoir until the desired hematocrit was achieved. The blood was then diverted to a transfer pack until all the blood from the venous reservoir, heat exchanger, and membrane oxygenator had been filtered and hemoconcentrated. This transfer pack was given to the anesthetist for reinfusion into the patient.
16228528|NCT01173809|Drug|Amiodarone|Patient will continue taking Amiodarone before, during and after ablation (8 weeks post-ablation).
16228529|NCT01173809|Drug|Amiodarone|Amiodarone therapy will be stopped at least 5-months before ablation procedure and ablation will be performed off Amiodarone. Patients will not take Amiodarone during the blanking period (8 weeks post-ablation).
16228530|NCT01173796|Procedure|catheter ablation|perimitral flutter ablation by blocking the mitral isthmus
16228531|NCT01173796|Procedure|catheter ablation|cardioversion and repeat isolation of pulmonary veins (PV) with ablation of additional triggers
16228532|NCT01173770|Drug|ADC3680B|Escalating single doses ADC3680B or Placebo over 5 study periods
16228533|NCT01173770|Drug|ADC3680B|ADC3680B or Placebo for 7 days
16228534|NCT01173770|Drug|ADC3680B|Single doses ADC3680B over 2 study periods under fasted and fed conditions
16228535|NCT01173757|Drug|PF-04995274|Single dose of up to 5 mg PF-04995274, delivered in solution on study day 1
16228536|NCT01173744|Device|Gamma-3 Nail|Gamma-3 Nail (stryker)
16228537|NCT01173744|Device|DHS|DHS (Zimmer)
16228538|NCT01173731|Drug|AFQ056|
16228539|NCT01173718|Device|GORE® ACUSEAL Vascular Graft|Surgical implantation of the GORE® ACUSEAL Vascular Graft for Hemodialysis per the Investigator's standard of practice.
16228540|NCT01173692|Drug|Minocycline|100 mg twice daily (200 mg) by mouth , every day for 7 weeks starting first day of radiation therapy.
16228541|NCT01173692|Drug|Placebo|Twice daily by mouth, every day for 7 weeks starting at first day of radiation therapy.
16228542|NCT01173679|Drug|dasatinib|Taken orally once a day on days 1-14 of each 28-day cycle
16228543|NCT01173679|Drug|Rituximab|Given intravenously, 375 mg/m2 each cycle (dose split, given on Days 3+4 of cycle 1, variable after that).
16228544|NCT01173679|Drug|fludarabine|Given intravenously, 25 mg/m2/day, for 3 doses per cycle (Days 3-5 in cycle 1, Days 1-3 after that)
16228545|NCT01173666|Procedure|stenting angioplasty plus medical therapy|Patients will be treated by stenting angioplasty of renal artery plus medical therapy. Medical therapy is based on antihypertensive, statin or antiplatelet drugs according to clinical indications.
16228546|NCT01173666|Drug|Medical therapy|Patients will be treated by standard medical therapy. Medical therapy is based on antihypertensive, statin or antiplatelet drugs according with clinical indications.
16228547|NCT01173653|Other|Smoking Cessation|Randomly introducing patients to a Department of Health program to help them quit smoking.
16228548|NCT01173653|Other|Smoking Cessation|A simple intervention where ED patients who were motivated to quit smoking were put in direct phone contact with a trained smoking cessation counselor during their ED stay.
16228549|NCT01173640|Drug|Midazolam|2 mg oral dose
16228550|NCT01173640|Dietary Supplement|resveratrol (single dose)|1 g oral dose
16228551|NCT01173640|Dietary Supplement|resveratrol (multiple dose)|1 g oral dose for 8 days
16228552|NCT01173627|Drug|Test fentanyl citrate 400 mcg troche|Test fentanyl citrate 400 mcg troche administered as a single dose under fasted conditions
16228553|NCT01173627|Drug|Actiq 400 mcg|Actiq 400 mcg administered as a single dose under fasted conditions
16228554|NCT01173601|Drug|LY2216684|
16228555|NCT01173601|Drug|Placebo|
16228556|NCT01173601|Drug|SSRI|Participants should have been on their SSRI for at least 6 weeks prior and were to continue on their stable dose throughout the study.
16228557|NCT01173588|Other|yogurt added with bifidobacteria and soluble fiber (YBF)|Yogurt in YBF was added with 1.5 g inulin/100 g and ≥5 x 107 CFU of bifidobacterium/mL
16228558|NCT01173562|Drug|Mebendazole|Type= exact number, unit= mg, number= 500, form= chewable tablet, route= oral use. One mebendazole 500-mg chewable tablet taken on Day 1.
16228559|NCT01173549|Drug|Canagliflozin/Placebo Placebo/Canagliflozin|Part 2: 240 mL water 20 min prior to the MMTT on Day 1 of Periods 1 and 2 in each treatment sequence (1 dose of canagliflozin in Period 1 followed by 1 dose of placebo in Period 2 and then crossover to 1 dose of placebo in Period 1 followed by 1 dose of canagliflozin in Period 2).
16228560|NCT01173549|Other|no intervention|Part 1: 240 mL water 10 minutes (min) prior to the start of the MMTT on Day 1 of Periods 1 and 2. Periods 1 and 2 will be separated by 7 to 21 days.
16228561|NCT01173536|Drug|GDC-0449|Oral repeating dose
16228562|NCT01173536|Drug|moxifloxacin|Oral single dose
16228563|NCT01173536|Drug|placebo|Oral repeating dose
16228564|NCT01173523|Drug|STA-9090|
16228565|NCT01173510|Drug|Raltegravir plus Truvada|Raltegravir 400 mg twice daily plus tenofovir/emtricitabine (Truvada) one tablet once daily
16228566|NCT01173510|Drug|Atripla|Efavirenz/Emtricitabine/Tenofovir DF one tablet once daily
16228567|NCT01173497|Drug|INIPARIB + irinotecan|21 day cycle
16228568|NCT01173471|Drug|AZD4017|tablet, oral, one tablet once daily, 28 days
16228569|NCT01173471|Drug|Placebo|matching placebo tablet, oral, one tablet once daily, 28 days
16228570|NCT01173471|Drug|AZD4017|tablet, oral 2 tablets twice daily, 28 days
16228571|NCT01173471|Drug|Placebo|matching placebo tablets, oral, 2 tablets twice daily, 28 days
16228572|NCT01173432|Device|continuous positive airway pressure|an device to be used during sleep, which was a nasal mask connected to a device with pressure applied to upper airway
16228573|NCT01173419|Device|VNUS RF ClosureFAST|VNUS® RF ClosureFAST is a minimally invasive varicose vein treatment procedure that uses radiofrequency energy (electricity) to heat, collapse and seal off the targeted blood vessels.
16228574|NCT01173419|Device|VenaCure EVLT NeverTouch|Endovenous Laser Treatment (EVLT) uses laser energy, which is a highly concentrated beam of light to treat varicose veins.
16228575|NCT01173406|Behavioral|CPAP education|Standard CPAP education plus an session and one telephone follow up
16228576|NCT01173393|Procedure|PARAMEDIC COOLING|"For patients randomised to paramedic cooling:
~LMA/ Intubation and ventilation with 100% oxygen
~Measure temperature using tympanic probe and record
~Paramedic cooling using infusion of 20mL/kg cold fluid via IV during CPR
~If temperature >34.5ºC, infuse further 10mL/kg stat
~After ROSC, infuse further (max 2 litres) ice-cold saline
~If shivering occurs post resuscitation and intubated, administer midazolam 2-5mg IV and pancuronium 8 mg."
16228577|NCT01173380|Other|Soy nuts|Oil roasted soy nuts with 101 milligrams of soy isoflavones per day for 4 weeks
16228578|NCT01173380|Other|Matched food|Control food (matched for calories and macronutrients) per day for 4 weeks
16228579|NCT01173367|Other|Aggressive Fever Treatment|Patients assigned to the aggressive fever treatment protocol will receive acetaminophen 650 mg enterally every 6 hours for fever ≥ 38.3°C and external cooling will be initiated for temperatures ≥ 39.5°C. Acetaminophen and external cooling will be discontinued once core temperature is less than 38.3°C and 39.5°C respectively.
16228580|NCT01173367|Other|Permissive Fever Treatment|Patients assigned to the permissive treatment strategy will not receive anti-pyretic therapy until the temperature reaches 40.0°C at which point they will receive acetaminophen 650mg every 6 hours. External cooling will be initiated for temperatures ≥ 40.5°C. Acetaminophen and external cooling will be discontinued once core temperature is less than 40.0°C and 40.5°C respectively.
16228581|NCT01173354|Dietary Supplement|Free balanced amino acid mixture|7 g free amino acids provided as a one time bolus, including 15 g carbohydrates. As part of the total amount of essential amino acids 24% is leucine.
16228582|NCT01173354|Dietary Supplement|Free essential amino acid mixture|7 g free essential amino acids provided as a one time bolus, including 15 g carbohydrates. As part of the total amount of essential amino acids 40% is leucine.
16228583|NCT01173341|Diagnostic Test|Echocardiography|Prior to chemotherapy, prior to and after anthracyclines, every 6 weeks during trastuzumab, and yearly for up to 10 years.
16228584|NCT01173341|Other|Blood Collection|Drawn at first chemo treatment and periodically during treatment (exact schedule varies with clinically ordered treatment plan), then annually for up to 10 years. Blood is banked for future biomarker testing.
16228585|NCT01173341|Other|Symptoms Questionnaire|Survey collected at first chemotherapy, periodically during therapy (exact schedule determined by clinically ordered treatment regimen), and annually for up to 10 years.
16228586|NCT01173328|Behavioral|Pursed-lip breathing|Pursed-lip breathing involves a nasal inspiration followed by expiratory blowing against partially closed lips, avoiding forceful exhalation.
16228587|NCT01173328|Behavioral|Normal Breathing|
16228588|NCT01173315|Dietary Supplement|vitamin and mineral supplementation|Group MV: Zinc sulfate and Magnesium oxide (providing 10 mg Zn and 125 mg Mg) and vitamin C (100 mg) and vitamin E (100 mg); Group MVB: both of the above mineral and vitamin supplements plus vitamin B1 (5 mg), vitamin B2 (5 mg), vitamin B6 (5 mg), biotin (50 µg), vitamin B12 (5 µg) and folic acid (0.5 mg); Group P: starch (placebo).
16228589|NCT01173302|Biological|Rabies vaccine, manufactured by ChengDa|1 dose before the antibody is tested
16228685|NCT01172730|Device|Ultrasound scanning|Ultrasound scanning is used to define needle insertion point and depth of epidural space.
16228590|NCT01173289|Radiation|External Beam Radiotherapy|"Definition of target volume:
~Gross tumor volume (GTV) = gross tumor defined with intravenous bolus contrast administration given CT scan
~Clinical target volume (CTV) = GTV + included volumes of clinical and suspected subclinical involvement (draining lymph nodes)
~Planning target volume (PTV) = CTV + 5-10 mm of lateral, craniocaudal, and anteroposterior margins.
~Radiation dose and planning
~Total dose 65 Gy for gross tumor, 62.4 Gy for microscopic involved area, 58.5 Gy for high risk lymph node area and 52 Gy for elective lymph node area in 26 fractions during 6 weeks
~Dose prescription: 90% isodose volume of prescribed dose encompassed PTV
~The dose-volume histogram (DVH) of targets, such as GTV, CTV, and PTV, and the normal tissues, such as the esophagus, lung, contralateral normal thyroid, arytenoids, vocal cord and spinal cord, etc., was calculated."
16228591|NCT01173276|Other|Sperm Washing with Intrauterine Insemination (IUI)|For semen samples, seminal fluid will be separated from sperm using a density gradient/swim-up separation technique. The purified sperm sample will be washed, and screened for HIV RNA using sensitive real-time RT-PCR. Samples with detectable traces of HIV RNA will not be used for insemination. Samples with no detectable traces of HIV RNA will be used for a standard intrauterine insemination of the female partner.
16228592|NCT01173263|Other|BIS 70 maintained|Each patient will receive propofol sedation by continuous infusion titrated to a BIS level of 70.
16228593|NCT01173263|Other|BIS level 50|Each patient will receive propofol sedation by continuous infusion titrated to a BIS level of 50.
16228594|NCT01173263|Other|BIS 35|Each patient will receive propofol sedation by continuous infusion titrated to a BIS level of 35.
16228595|NCT01173250|Procedure|adding diverting ileostomy|
16228596|NCT01173250|Procedure|omitting diverting ileostomy|
16228597|NCT01173237|Procedure|Use tracheal intubation for surfactant therapy|Surfactant endotracheal administration after tracheal intubation
16228598|NCT01173237|Procedure|Use of Proseal laryngeal mask airway for surfactant therapy|Surfactant use by proseal laryngeal mask airway
16228599|NCT01173224|Drug|Placebo|Placebo: Cohort 1: 20mg DAS181 or placebo for 1 day (total dose of 20mg). Cohort 2: 20mg DAS181 or placebo for 10 consecutive days (total dose of 200mg). Cohort 3: 30mg DAS181 or placebo for 1 day (total dose of 30mg).
16228600|NCT01173224|Drug|DAS181|DAS181 F03: Cohort 1: 20mg DAS181 or placebo for 1 day (total dose of 20mg). Cohort 2: 20mg DAS181 or placebo for 10 consecutive days (total dose of 200mg). Cohort 3: 30mg DAS181 or placebo for 1 day (total dose of 30mg).
16228601|NCT01173211|Biological|Trivalent inactivated influenza vaccine|Three licensed 2010-2011 seasonal inactivated trivalent influenza vaccines. Single intramuscular 0.5 mL dose. Each vaccine is formulated to contain 45 micrograms (mcg) hemagglutinin (HA) per 0.5 mL dose. Thimerosal is a preservative used in some vaccines. Fluzone, Agriflu and Fluarix do not contain thimerosal. For Fluarix, the tip cap and rubber plunger of the needleless prefilled syringes contain dry natural latex rubber.
16228602|NCT01173211|Biological|Trivalent inactivated influenza vaccine|Three licensed 2010-2011 seasonal inactivated trivalent influenza vaccines. Single intramuscular 0.5 mL dose. Each vaccine is formulated to contain 45 micrograms (mcg) hemagglutinin (HA) per 0.5 mL dose. Thimerosal is a preservative used in some vaccines. Fluzone, Agriflu and Fluarix do not contain thimerosal. For Fluarix, the tip cap and rubber plunger of the needleless prefilled syringes contain dry natural latex rubber..
16228603|NCT01173211|Biological|Trivalent inactivated influenza vaccine|Three licensed 2010-2011 seasonal inactivated trivalent influenza vaccines. Single intramuscular 0.5 mL dose. Each vaccine is formulated to contain 45 micrograms (mcg) hemagglutinin (HA) per 0.5 mL dose. Thimerosal is a preservative used in some vaccines. Fluzone®, Agriflu® and Fluarix® do not contain thimerosal. For Fluarix, the tip cap and rubber plunger of the needleless prefilled syringes contain dry natural latex rubber.
16228604|NCT01173198|Device|WAVEFRONT Optimized LASIK|30 patients
16228605|NCT01173198|Device|WAVEFRONT GUIDED LASIK|30 patients
16228606|NCT01173172|Radiation|Boron Neutron Capture Therapy|Boronophenylalanine (BPA) 500 mg/kg on D1 and D30 followed by BNCT for 2 fractions (D1 and D30)
16228607|NCT01173159|Drug|Omegaven|For the first two days of treatment, subjects will receive Omegaven® at 0.5 g/kg per day to assess tolerance and will progress to a maintenance dosage of up to 1g/kg per day over 12 hours at an infusion rate of 1 g/kg/12 hours (10 ml/kg/12 hours). Dosing is based on previously described dosing of fish-oil emulsions as monotherapy noted within the literature. Omegaven® will be infused intravenously through either a central or peripheral catheter in conjunction with other parenteral nutrition containing dextrose and amino acids. Omegaven® is isotonic. It is compatible with parenteral nutrition solutions and may be co-infused via y-site.
16228608|NCT01173120|Device|Abatacept combination product (ACP)|Abatacept Solution, Subcutaneous, 125 mg/device, Weekly, 3 months
16228609|NCT01173107|Drug|colchicine|colchicine 1T tid
16228610|NCT01173094|Device|Percutaneous Transluminal Angioplasty|Before operation, take aspirin 100mg every day. During the operation, balloon is delivered by a catheter and positioned through the narrowing in the artery. Then expand the balloon against the wall of the blood vessel to provide a wider channel for blood.
16228611|NCT01173094|Device|below-knee arterial bypass|Before operation, take aspirin 100mg every day. Perform bypass to below-knee(posterior tibial，anterior tibial or peroneal)arteries, saphenous vein graft with end to side anastomoses
16228612|NCT01173081|Drug|Teriparatide|20mcg once daily for 16 weeks or until study endpoint is achieved.
16228613|NCT01173081|Drug|Placebo|matching dose of 20mcg of placebo once daily for 16 weeks or until study endpoint is achieved
16228614|NCT01173068|Drug|Ertapenem|Prescribed IV Ertapenem 1gm (or renally adjusted dose) will be administered every 24 hours. The duration of treatment will be determined by the clinician and this typically is 2 weeks, or as clinically indicated.
16228615|NCT01173055|Drug|milnacipran|Milnacipran will be given orally twice daily in tablet form at different times during the course of the study. The highest dose of milnacipran to be used in the study is 200mg/day.
16228616|NCT01173055|Drug|Placebo|Placebo will be given orally twice daily in tablet form at different times during the course of the study.
16228617|NCT01173042|Dietary Supplement|Peanuts|Shake containing 3.0oz of peanuts (including skin) + control (heavy whipping cream, glucose and chocolate syrup)
16228618|NCT01173042|Dietary Supplement|Glucose and whipping cream|An oral liquid glucose (75g) and fat (high saturated fat from 60g heavy whipping cream) load. Chocolate syrup is added for flavor.
16228720|NCT01172431|Drug|Indapamide|Indapamide SR 1.5mg qd
16228721|NCT01172431|Drug|Hydrochlorothiazide|Hydrochlorothiazide 25mg qd
16228619|NCT01173042|Dietary Supplement|Oil Blend|Shake containing an oil blend (sunflower, sesame, olive and palm oils) + control (heavy whipping cream, glucose and chocolate syrup). The amount of oil added to the control will provide an equivalent amount of fat to that provided in 3 oz (85g) of peanuts
16228620|NCT01173029|Drug|Anti-hypertensive drug treatment|Anti-hypertensive drug treatment was non-investigational. Drug regimen, including which drug and the number of drugs prescribed, was left at discretion of the physician who carried primary assistance.
16228621|NCT01173016|Drug|Laronidase|Laronidase 0.58 mg/kg intravenously (IV) once a week for a maximum of 2 years
16228622|NCT01173003|Drug|Mifepristone, misoprostol|
16228623|NCT01172990|Procedure|Immediate Invasive Management|Patients allocated to the immediate invasive strategy will be taken to the catheter lab immediately (< 90 minutes from randomisation) in accordance with local primary angioplasty policy. Angiogram +/- same sitting PCI will be performed according to local policy and guidelines
16228624|NCT01172990|Procedure|Conventional Management|Patients allocated to the conventional management group will have medical stabilisation and will undergo angiogram +/- PCI between 24 to 48 hours from randomisation according to local policy and guidelines
16228625|NCT01172964|Drug|flucytosine|Given orally
16228626|NCT01172964|Other|polymerase chain reaction|Correlative studies
16228627|NCT01172964|Other|immunohistochemistry staining method|Correlative studies
16228628|NCT01172964|Biological|gene therapy|Injected at the time of the surgery to resect the tumor
16228629|NCT01172964|Other|pharmacological study|Correlative studies
16228630|NCT01172964|Other|3-Tesla magnetic resonance imaging|Correlative studies
16228631|NCT01172964|Other|laboratory biomarker analysis|Correlative studies
16228632|NCT01172964|Procedure|therapeutic conventional surgery|Surgery to resect the tumor
16228633|NCT01172964|Biological|E. coli CD-expressing genetically modified neural stem cells|Injected at the time of the surgery to resect the tumor
16228634|NCT01172951|Other|Oral glucose tolerance test|75g anhydrous glucose powder mixed with 100mls water
16228635|NCT01172951|Other|Oral lipid tolerance test|150ml drink composed of 2 commercially available high fat products
16228636|NCT01172938|Drug|Apremilast 20mg|Apremilast 20 mg twice daily, orally
16228637|NCT01172938|Drug|Apremilast 30mg|Apremilast 30 mg twice daily, orally
16228638|NCT01172938|Drug|Placebo + 20 mg Apremilast|Placebo + 20 mg Apremilast
16228639|NCT01172938|Drug|Placebo + 30 mg Apremilast|Placebo + 30 mg Apremilast
16228640|NCT01172925|Drug|Tiotropium|Inhaler
16228641|NCT01172925|Drug|Placebo|Inhaler
16228642|NCT01172912|Biological|filgrastim|
16228643|NCT01172912|Biological|pegfilgrastim|
16228644|NCT01172912|Drug|carboplatin|
16228645|NCT01172912|Drug|cisplatin|
16228646|NCT01172912|Drug|dexamethasone|
16228647|NCT01172912|Drug|etoposide|
16228648|NCT01172912|Drug|ifosfamide|
16228649|NCT01172912|Other|high-dose chemotherapy with autologous stem cell rescue|
16228650|NCT01172912|Other|laboratory biomarker analysis|
16228651|NCT01172912|Procedure|autologous hematopoietic stem cell transplantation|
16228652|NCT01172912|Procedure|peripheral blood stem cell transplantation|
16228653|NCT01172899|Procedure|laparoscopic adjustable gastric band|Laparoscopic gastric band placement. Combined lifestyle interventions will continue after surgery.
16228654|NCT01172899|Behavioral|Combined life style interventions|Control group will receive standard therapy consisting of combined lifestyle interventions.
16228655|NCT01172873|Drug|D-cycloserine|50 mg dose of D-cycloserine administered at the end of each session of Cognitive Behavioral Therapy With Exposure and Response Prevention: twice weekly CBT/ERP of 60 minutes
16228656|NCT01172873|Behavioral|Exposure and Response Prevention (EX/RP)|Exposure and response prevention treatment. Participants complete graded exposure during twice weekly treatment sessions with therapist
16228657|NCT01172860|Device|EndoVe endoscopic electroporation|The EndoVe device enables the endoscopic treatment of gastrointestinal tumor tissues. The device is placed on the tumor tissue and an electrical pulse of less than 1msec is delivered. The tumor tissue becomes permeabilised and absorbs much greater concentrations of the drug than the surrounding healthy tissue
16228658|NCT01172847|Drug|oseltamivir [Tamiflu]|multiple oral doses
16228659|NCT01172847|Drug|rimantadine|multiple oral doses
16228660|NCT01172834|Behavioral|Health Coaching|A manual-driven group Health Coaching intervention. Once a week for 3 months.
16228661|NCT01172821|Drug|placebo|Placebo that represents BI drug
16228662|NCT01172821|Drug|placebo|Placebo that represents comparator
16228663|NCT01172821|Drug|placebo|Placebo that represents comparator
16228664|NCT01172821|Drug|tiotropium Respimat® low dose|IMP
16228665|NCT01172821|Drug|placebo|Placebo that represents BI drug
16228666|NCT01172821|Drug|tiotropium Respimat® high dose|IMP
16228667|NCT01172821|Drug|50 mcg salmeterol HFA MDI|Active comparator
16228668|NCT01172821|Drug|placebo|Placebo that represents comparator
16228669|NCT01172808|Drug|Placebo|Placebo that represents comparator
16228670|NCT01172808|Drug|tiotropium Respimat® low dose|IMP
16228671|NCT01172808|Drug|Placebo|Placebo that represents comparator
16228672|NCT01172808|Drug|Placebo|Placebo that represents comparator
16228673|NCT01172808|Drug|tiotropium Respimat® high dose|IMP
16228674|NCT01172808|Drug|50 mcg salmeterol HFA MDI|Active comparator
16228675|NCT01172808|Drug|Placebo|Placebo that represents BI drug
16228676|NCT01172808|Drug|Placebo|Placebo that represents BI drug
16228677|NCT01172795|Behavioral|Relaxation session|30 minutes relaxation session (audiotape)
16228678|NCT01172795|Behavioral|Neurocognitive test battery|the psychomotor vigilance task, span task and the stroop task on computer
16228679|NCT01172782|Drug|Hydromorphone|2.5, 5, 10 ug of hydromorphone, intrathecal injection, single injection. duration of intrathecal injection are not fully studied.
16228680|NCT01172769|Biological|Temsirolimus|"After dissolving and dilution 25 mg of temsirolimus will be administered i.v. once a week by 30 minute infusion.
~Study treatment will continue until tumor progression or unless unacceptable toxicity is encountered."
16228681|NCT01172756|Drug|Riociguat (BAY63-2521)|0.5 mg single oral dose
16228686|NCT01172717|Drug|Panitumumab|Panitumumab will be given by intravenous infusion at a dose of 9 mg/kg on day 1 of study and then every 3 weeks until progression of disease
16228687|NCT01172704|Behavioral|Skills Building - Motivational Interviewing|"SB-MI incorporates Motivational Interviewing strategies into a psycho-educational HIV risk reduction protocol to help participants identify high-risk behaviors, reduce ambivalence about these behaviors, increase motivation to change behaviors, and develop a specific plan of action for risk reduction. Consistent with MI, information gathered at baseline regarding HIV risk behaviors is systematically reviewed in a personalized way with each participant at the outset of the intervention. This is designed to engage participants in becoming active agents in the change process and to assist participants in recognizing discrepancies between their current risk behaviors and goals and values, which typically do not include HIV infection or transmitting HIV to others. Also consistent with the principles of MI, participants are empowered to choose those educational and skills-based modules which fit their personal risk profile and values."
16228688|NCT01172691|Procedure|Inhaled Nitric Oxide (iNO)|iNO or placebo will be administered at 40 ppm during the procedure starting when the Warm Ischemia Time begins - liver from ice. Stop when patient transported to ICU
16228689|NCT01172652|Drug|Ziprasidone|The minimum dose during study participation will be 40 mg/day, and the maximum dose allowed will be 160 mg/day.
16228690|NCT01172652|Drug|Placebo|Inactive control
16228691|NCT01172639|Drug|Methotrexate|Methotrexate tablet
16228692|NCT01172639|Drug|Sulfasalazine|Sulfasalazine tablet
16228693|NCT01172639|Drug|Leflunomide|Leflunomide tablet
16228694|NCT01172639|Drug|Prednisone|Prednisone tablet
16228695|NCT01172626|Drug|valproate sodium|oral administration,15-30mg/kg,daily
16228696|NCT01172626|Genetic|Polymorphism Analysis|Analysis of genetic polymorphisms of the drug metabolic enzymes involving in the deactivation and elimination of Valproate sodium
16228697|NCT01172626|Other|Pharmacokinetic analysis|laboratory analysis of concentration of Valproate sodium and 4-ene-Valproate in plasma
16228698|NCT01172600|Other|Entonox|Those randomized to Entonox will inhale the gas through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery.
16228699|NCT01172600|Other|Oxygen|Those randomized to oxygen will inhale it through a mouthpiece throughout the procedure and also continue to receive it for a total of 4 hours in the recovery.
16228700|NCT01172587|Other|Behavioral Couples Therapy|Couples participate in 12 sessions of Behavioral Couples Therapy designed to reduce substance use and increase relationship functioning.
16228701|NCT01172574|Other|Motor control exercise|Participants of the exercise group were trained to consciously co-activate the transversus abdominis, pelvic floor and thoracic erector spinae muscle, relax the lumbar multifidus and use the diaphragmatic breathing pattern. They were encouraged to activate the specific muscles of the trunk regularly during daily activities, particularly in situations where they anticipated or experienced pain such as walking, twisting, lifting low-lying objects and working with the hands in sitting or standing positions
16228702|NCT01172561|Behavioral|Lay Health Advisor Education Intervention|The individualized health education intervention consisted of an intensive, reinforced, face to face, interactive educational program. The program included an initial meeting of 45 60 minutes, followed by two telephone calls and reinforcement by a series of four postcards mailed at regular intervals and a second visit. Each woman will be enrolled in the intervention program for approximately 12 to 14 months.
16228703|NCT01172561|Behavioral|Usual Care Group|All women over age 18 encouraged to obtain Pap smears appropriate for their risk profile, the comparison arm included a low-literacy brochure to encourage women to receive screening. The brochure was designed to answer basic questions about Pap smears and provide instructions on how to obtain a Pap smear.
16228704|NCT01172548|Drug|imatinib mesylate|
16228705|NCT01172535|Drug|Lopinavir/ritonavir|Heat-stable tablets of 100 mg lopinavir, 25 mg ritonavir, or liquid formulation of 80 mg lopinavir, 20 mg ritonavir, dosed according to World Health Organization (WHO) pediatric weight band dosing guidelines
16228706|NCT01172522|Drug|Fexofenadine|Fexofenadine 1%
16228707|NCT01172522|Drug|Placebo|Placebo
16228708|NCT01172509|Drug|R-baclofen|oral R-baclofen at 0x2, 3, 10, and 25 mg
16228709|NCT01172496|Drug|treprostinil diethanolamine|Subjects will be administered a 1 mg dose of treprostinil diethanolamine as a single tablet, and treprostinil diethanolamine oral solution 0.25 mg dose every 2 hours for four doses (1 mg total).
16228710|NCT01172483|Procedure|general practice in primary care and education|education of chronic disorders in PC
16228711|NCT01172483|Other|Multimodal community program|The intervention was an 8-week programme of MMPP combined with DWR, delivered by physiotherapists in groups of 8 to 10 participants. One-hour sessions were conducted 3 times per week, consisting of DWR and an individualised MMPP of therapeutic exercises combined with education based on cognitive-behavioural principles. Each session was comprised of 30 minutes of land-based exercise followed by 20 minutes of DWR, with an additional 10 minutes of warm-up and cool-down time. Deep water running stimulates running using a flotation device in water levels over head height. During the first two weeks of the intervention, participants undertook a low-intensity adaptation interval to learn proper exercise technique. For the remaining six weeks, participants were instructed to maintain a constant speed to achieve the prescribed HRAT. If experiencing pain while exercising, participants were asked to temporarily reduce intensity and return to target HR as capable.
16228712|NCT01172470|Drug|Gemcitabine|4 doses of induction chemotherapy every 2weeks, IV (in the vein)
16228713|NCT01172470|Drug|Pemetrexed|"Induction Chemotherapy:
~4 doses of induction chemotherapy every 2weeks(Days 1, 15, 28, and 42), through an infusion for approximately 10 minutes.
~Chemoradiotherapy:
~Day 1,22, and 43through IV infusion over a period of 10 minutes"
16228714|NCT01172470|Drug|Carboplatin|"Chemoradiotherapy:
~Day 1, 22 and 4 through IV infusion over a period of 1 hour."
16228715|NCT01172457|Procedure|Epiduroscopy with oxygen therapy|Patients in this group will receive 30 mL of oxygen by epiduroscopy.
16228716|NCT01172457|Procedure|Epiduroscopy with ozone therapy|Patients in this group will receive 30 mL of ozone at a concentration of 30 mcg / ml by epiduroscopy.
16228717|NCT01172444|Drug|Mesalamine|Supporitory, Once Daily, Per Rectal for 6 Weeks
16228718|NCT01172444|Drug|Canasa|Suppository, Once Daily, Per Rectal for 6 Weeks
16228719|NCT01172444|Drug|Placebo|Suppository, Once Daily, Per Rectal for 6 Weeks
16228722|NCT01172418|Drug|Alemtuzumab|Alemtuzumab used as part of combined Induction.
16228723|NCT01172418|Drug|Daclizumab|Daclizumab used as part of combined induction.
16228724|NCT01172418|Drug|Thymoglobulin|Thymoglobulin used as part of combined induction.
16228725|NCT01172405|Drug|Ibuprofen plus caffeine|One or two tablets of ibuprofen 400 mg + caffeine 200 mg when presenting headache.
16228726|NCT01172405|Drug|Ibuprofen|One or two tablets of ibuprofen 400 mg when presenting headache.
16228727|NCT01172392|Drug|Pegylated interferon-alpha-2a|180 mcg / wk / SC from D0 to W48
16228728|NCT01172392|Drug|Nucleotidic or Nucleosidic Treatment|Analog treatment according to investigators practice
16228729|NCT01172379|Drug|E2007|"Experimental 1 Drug: E2007
~0.5 mg 1 tablet per day"
16228730|NCT01172379|Drug|E2007|"Experimental 2 Drug: E2007
~1.0 mg 1 tablet per day"
16228731|NCT01172379|Drug|E2007|"Drug: E2007
~2.0 mg 1 tablet per day"
16228732|NCT01172379|Other|Placebo Comparator|Placebo 1 tablet per day
16228733|NCT01172353|Drug|sodium bicarbonate|hydration with sodium bicarbonate 1ml/Kg/h for 6 hours
16228734|NCT01172353|Drug|saline|hydration with saline 1ml/Kg/h for 6 hours
16228735|NCT01172340|Behavioral|Behavioral and support intervention|Individual counseling session with diet and exercise recommendations, 16 weekly group sessions, 8 weeks of followup phone support
16228736|NCT01172340|Behavioral|Wait-listed control group|Controls receive the same individual counseling session as intervention group; receive mailed health information; are offered group sessions after last post-measure
16228737|NCT01172327|Behavioral|Multicomponent exercise|This intervention is a self-directed, multicomponent, exercise intervention. Participants exercise on their own and follow a progressive stepped program that occurs in the following order: cardiorespiratory exercises, flexibility exercises, strength (upper and lower body) exercises, and balance exercises. Participants also complete a daily log of their exercises and return the logs every week for 12 weeks. The active intervention phase is 12 weeks.
16228738|NCT01172327|Behavioral|Nutrition|This arm is a self-directed nutrition intervention. Participants follow a progressive stepped program that occurs in the following order: fruits, vegetables, grains, meat and beans. Participants also complete a daily log of their dietary intake and return the logs every week for 12 weeks. The active intervention lasts for 12 weeks.
16228739|NCT01172314|Dietary Supplement|EAA+LEU vs total AA|15 g as a bolus
16228740|NCT01172314|Dietary Supplement|Total AA vs EAA+LEU|15 g as a bolus
16228741|NCT01172301|Dietary Supplement|Essential amino acid intake + Leucine vs total AA supplement|7 g as bolus
16228742|NCT01172288|Drug|N-Acetylcysteine (NAC)|1 600mg capsule twice a day for 2 weeks and then 2 600mg capsules twice a day for the remaining 10 weeks of the trial.
16228743|NCT01172288|Drug|Placebo|1 600mg Capsule twice a day for two weeks then 2 600mg capsules twice a day for the remaining 10 weeks of the study. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
16228744|NCT01172275|Drug|N-Acetylcysteine|1 900mg tablet once a day for 1 week, then 1 900mg tablet twice a day for 1 week and then 1 900mg tablet three times a day for the remaining 10 weeks of the trial.
16228745|NCT01172275|Other|Placebo|1 900mg tablet once a day for 1 week, then 1 900mg tablet twice a day for 1 week and then 1 900mg tablet three times a day for the remaining 10 weeks of the trial. Children receiving placebo will be offered the active intervention after the double-blind portion of the trial.
16228746|NCT01172262|Procedure|MRI|This is an observational study, no intervention will occur.
16228747|NCT01172249|Drug|Glucosamine sulfate + chondroitin sulfate - MANTECORP|1 capsule three times daily before meals (glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg).
16228748|NCT01172249|Drug|Glucosamine sulfate + chondroitin sulfate - CONDROFLEX|1 capsule three times daily before meals (glucosamine sulfate 500 mg + sodium chondroitin sulfate 400 mg).
16228749|NCT01172236|Drug|Lactoferrin|"Experimental group: newborns (group A) will receive a daily dose of 100 mg of lactoferrin (Dicorfam® Elleffe 1''% 2C supplement containing lactoferrin) + standard therapy.
~Control group: newborns (group B) will receive only standard therapy and they will be used as controls."
16228750|NCT01172236|Drug|Lactoferrin|Experimental group: 650 newborns (group A) will receive a daily dose of 100 mg of lactoferrin (Dicorfam® Elleffe 1''% 2C supplement containing lactoferrin) + standard therapy.Control group: 650 newborns (group B) will receive only standard therapy and they will be used as controls.
16228751|NCT01172223|Drug|Myocet (Non-pegylated liposomal doxorubicin (NPLD))|60 mg/m^2 i.v. day 1 q3 weeks
16228752|NCT01172223|Drug|Paclitaxel|175 mg/m^2 i.v. day 1 q3 weeks
16228753|NCT01172223|Drug|Lapatinib (GW572016, Tykerb)|750-1500 mg/d orally daily until the day of the definitive surgery
16228754|NCT01172197|Drug|Levobupivacaine|Femoral bolus 150μM followed by femoral infusion 400μM
16228755|NCT01172197|Drug|Ropivacaine|Bolus and infusion
16228756|NCT01172184|Procedure|Cardiac catheterization|Before surgical intervention for severe mitral regurgitation, cardiac catheterization will be performed and left ventricular filling pressure will be assessed. Simultaneously, echocardiography, including left atrial distensibility, will be performed.
16228757|NCT01172171|Drug|Melatonin, N-acetyl-5-methoxytryptamine|The investigators will give the randomized patients 10 ml of 0,1 mg/ml melatonin intracoronarily and 490 ml of 0,1 mg/ml (49 mg) melatonin.
16228758|NCT01172171|Drug|Isotonic saline, Natrium chloride|The randomized patients will be given 10 ml of isotonic saline intracoronarily and 490 ml intravenously.
16228759|NCT01172145|Drug|Modafinil|100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks
16228760|NCT01172145|Drug|Placebo|100 mg in the morning for the first week and 200 mg in the morning for the remaining seven weeks
16228761|NCT01172119|Device|Biofreedom Drug Eluting Stent|Biofreedom DES with a standard dose of Biolimus A9TM
16228762|NCT01172119|Device|Biofreedom Drug Eluting Stent|Biofreedom DES with a low dose of Biolimus A9TM
16228763|NCT01172119|Device|Tuxus Liberte Drug Eluting Stent|Standard paclitaxel dose Taxus Liberte DES
16228764|NCT01172106|Behavioral|drug compliance|Mothers and their caregivers will be encouraged to comply with the given medication
16228765|NCT01172106|Behavioral|Encouragement of drug compliance|Mothers and their caregivers in the placebo comparator will receive an intervention of drug compliance encouragement
16228997|NCT01170299|Other|laboratory biomarker analysis|
16228766|NCT01172106|Behavioral|Family psychoeducation|The experimental group will receive family psychoeducation for 12 sessions
16228767|NCT01172080|Other|protocol of reminders regarding due colonoscopy|Participants receive two standardized letters followed by a phone call if they have not scheduled or completed their upcoming due colonoscopy
16228768|NCT01172067|Device|Cardiac Resynchronization Therapy|Patients will be optimized using QuickOpt (IEGM) algorithm installed on the Merlin device programmer within 2 weeks and 3 and 6 months after device implantation.
16228769|NCT01172067|Device|Optimization using echocardiography|Optimization of the AV/PV and VV delays using echocardiography
16228770|NCT01172054|Biological|VAX128|one IM injection
16228771|NCT01172054|Biological|Placebo|One IM injection
16228772|NCT01172041|Device|Real time position management system|Device to monitor respiration by using optical monitoring of a marker block placed on the abdomen of the patient.
16228773|NCT01172041|Device|LS PET/CT|PET/CT scanner for acquiring CT and PET images (3D and 4D)
16228774|NCT01172041|Drug|18-FDG|15mCi
16228775|NCT01172028|Drug|Taxotere (Docetaxel)|Taxotere is a third generation cytotoxic chemotherapy agent which is a semisynthetic taxane that inhibits cell division by promoting the rate of microtubule assembly and preventing microtubule depolymerization. It has broad antitumor activity in a range of solid tumors, and has been studied on a weekly as well as a biweekly dosing schedule.
16228776|NCT01172028|Drug|Alimta (Pemetrexed)|ALIMTA is a novel antifolate drug with three enzyme targets in the purine and pyrimidine synthetic pathway. It has broad activity in solid tumors and has been combined with a number of other chemotherapy agents. Its toxicity is modified by the use of continuous vitamin supplementation.
16228777|NCT01172015|Other|blood samples|
16228778|NCT01172002|Drug|Leflunomide|"Leflunomide, 20 mg/d, ORAL ,each day. Number of Cycles: until progression or unacceptable toxicity develops.
~Predonine, 10 mg/d, ORAL, each day. If extra renal flare occurs, the dose of predonine may be increased to 1mg/kg/day for not more than 2 weeks."
16228779|NCT01172002|Drug|Azathioprine|"Azathioprine,50-100 mg/d, ORAL ,each day . Number of Cycles: until progression or unacceptable toxicity develops.
~Predonine, 10 mg/d, ORAL, each day. If extra renal flare occurs, the dose of predonine may be increased to 1mg/kg/day for not more than 2 weeks."
16228780|NCT01171989|Biological|GSK2202083A vaccine|Intramuscular, one dose.
16228781|NCT01171989|Biological|Infanrix hexa™|Intramuscular, one dose.
16228782|NCT01171989|Biological|Menjugate™|Intramuscular, one dose.
16228783|NCT01171989|Biological|NeisVac-C™|Intramuscular, one dose.
16228784|NCT01171989|Biological|Synflorix™|Intramuscular, one dose.
16228785|NCT01171976|Drug|Ranibizumab|Ranibizumab (Lucentis®) was supplied in vials containing a dose of 0.5 mg/0.05 mL in an aqueous solution (pH 5.5) with histidine, trehalose, and polysorbate 20.
16228786|NCT01171963|Biological|GSK Biologicals' liquid human rotavirus vaccine 444563|Oral administration
16228787|NCT01171963|Biological|Placebo|Oral administration
16228788|NCT01171963|Biological|Infanrix™|Intramuscular administration
16228789|NCT01171963|Biological|Institute of Medical Biology Chinese Academy of Medical Sciences' Oral poliovirus vaccine (OPV)|Oral administration
16228790|NCT01171950|Device|CentriMag Ventricular Assist System|All patients will be treated with the CentriMag device for up to 30 days.
16228791|NCT01171937|Drug|Risperidone|children get randomized to either placebo or active risperidone
16228792|NCT01171937|Drug|Placebo|Children get randomized to either placebo or risperidone
16228793|NCT01171924|Drug|CUDC-101|CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 consecutively for 5 days on each 14 day cycle.
16228794|NCT01171924|Drug|CUDC-101|CUDC-101 administered as a 1 hour intravenous infusion at the maximum tolerated dose of 275 mg/m2 on Monday, Wednesday, Friday for three consecutive weeks of each 28 day cycle.
16228795|NCT01171911|Drug|Nicardipine , Esmolol|A loading dose of Nicardipine 10mg was at a bolus injected through vein , then continuous trans-venous titration at a speed 1ug/kg was kept. A loading dose of Esmolol 0.5mg/kg/min was at a bolus injected through vein , then continuous trans-venous titration at a speed 0.2mg/kg/min was kept.
16228796|NCT01171898|Drug|ARN-509 (Phase 1)|ARN-509 will be administered at a starting dose of 30 milligram per day (mg/day), with escalations to 60 mg, 90 mg, 120 mg, 180 mg, 240 mg, 300 mg, 390 mg, and 480 mg daily.
16228797|NCT01171898|Drug|ARN-509 (Phase 2)|ARN-509 will be administered at Maximum Tolerated Dose (MTD) and/or Recommended Phase 2 Dose (RP2D), determined in Phase 1.
16228798|NCT01171885|Drug|0.9% saline|20 ml of 0.9% saline
16228799|NCT01171885|Drug|Ropivacaine|20 ml of Ropivacaine 0.25%.
16228800|NCT01171885|Drug|Ropivacaine|20 ml of Ropivacaine 0.5%.
16228801|NCT01171859|Drug|Doxycycline + Tauroursodeoxycholic acid|doxycycline 100 mg twice a day for 12 months; tauroursodeoxycholic acid 250 mg three times a day for 12 months
16228802|NCT01171846|Other|Pelvic Floor Muscle training|"Women allocated to the intervention group will have five appointments with a specialist women's health physiotherapist (intervention physiotherapist) over 16 weeks who will prescribe a daily exercise programme and provide a Lifestyle Advice Sheet (focusing on weight loss, constipation, avoidance of heavy lifting, coughing and high-impact exercise) and relevant tailored advice (phase 1).
~Thereafter women in the intervention group will be offered Pilates-based classes, including PFMT, as maintenance (phase 2). Classes will be led by a physiotherapist who has undertaken Pilates training and will take place in six week blocks; each woman will be offered two six week blocks over a year. An exercise DVD will be provided for home use. Each woman will be offered a one-to-one review physiotherapy appointment at one and two years after randomisation."
16228803|NCT01171833|Drug|Sevoflurane|2.0 vol% prefilled in a corrugated circuit.
16228804|NCT01171833|Drug|Desflurane|6.0 vol% prefilled in a corrugated circuit.
16228805|NCT01171833|Drug|Isoflurane|1.2 vol% prefilled in a corrugated circuit.
16228806|NCT01171820|Device|TAXUS® Liberté™|Drug eluting stent implantation stent in the treatment of coronary artery disease in participants with Diabetes
16228807|NCT01171820|Device|XIENCE V® EECSS|Drug eluting stent implantation stent in the treatment of coronary artery disease in participants with Diabetes
16228808|NCT01171807|Drug|Dexamethasone 21-phosphate|6 monthly infusions of dexamethasone 21-phosphate loaded into autologous erythrocytes
16228809|NCT01171794|Drug|Ibuprofen|3 x 200mg (600mg total) x tid and one dosing on the subsequent day ( 4 doses total)
16228810|NCT01171794|Drug|Placebo|identical number of visually identical tasteless pills as ibuprofen arm
16228811|NCT01171781|Drug|cisplatin (3 weekly)|radiation with cisplatin (100mg/m2) on D1,D22,D43 and followed by adjuvant chemotherapy (3 cycles of FP)
16228812|NCT01171781|Drug|cisplatin (weekly)|radiation with 7 cycles of cisplatin (40mg/m2) on D1,8,15,22,29,36,43, and followed by adjuvant chemothrapy (FP X3)
16228813|NCT01171755|Drug|Gemcitabine TS-1|Gemcitabine (1,000mg/m2) will be administered on days 1 and 8 at every 3 weeks TS-1 will be administered orally according to body surface area (BSA) as follows : BSA<1.25 M2, 80 mg/day; 1.25 M2≤BSA<1.5 M2, 100 mg/day; 1.5 M2≤BSA, 120 mg/day for 14 consecutive days followed by a 7-day rest.
16228814|NCT01171742|Procedure|Intermittent hepatic inflow occlusion (IHIO)|Intermittent hepatic inflow occlusion (IHIO)'ll be usually performed 3 times during donor liver parenchymal resection, with each IHIO consisting of clamping of the hepatoduodenal ligament for 15 minutes, followed by reperfusion for 5 minutes.
16228815|NCT01171729|Biological|Autologous dendritic cell|Autologous dendritic cells pulsed with prostate cancer antigen and KLH
16228816|NCT01171716|Other|Meal Patterning|LP intake 3 meals and 6 meals HP intake 3 meals and 6 meals
16228817|NCT01171703|Device|femoral-popliteal bypass|Before operation, take aspirin 100mg every day. Groin and suprageniculate incision, PTFE graft with end to side anastomoses.
16228818|NCT01171703|Device|stent|Before operation, take aspirin 100mg every day. During the operation, stent is delivered by a catheter and positioned through the narrowing in the artery. The stent is then expanded against the wall of the blood vessel to provide a wider channel for blood. At last, use balloon dilate the stent.
16228819|NCT01171690|Drug|Teriparatide|The dose of teriparatide will be 20 mcg twice daily for the first week and 20 mcg daily for the second week. If hypocalcemia recurs after 2nd week, teriparatide will be continued for a 3rd week and then discontinued.
16228820|NCT01171677|Behavioral|IntenSati|"IntenSati (a blending of the words intention and sati, the Pali term for mindfulness) combines simple yet vigorous physical movements taken from yoga, martial arts, kickboxing and dance with spoken positive affirmation (e.g. I believe I will succeed, I am strong and I am confident) that are recited simultaneously with the execution of the movements. Indeed, one of the most common reports of IntenSati practitioners is the power of the spoken affirmations to stick in your head long after the workout is complete. The literature suggests that both the kind of high level aerobic exercise provided by IntenSati as well as the positive affirmations may have measurable beneficial effects on cognitive function, mood, self efficacy and self esteem."
16228821|NCT01171664|Drug|Placebo|Tablet, one BID
16228822|NCT01171664|Drug|STAHIST|STAHIST in tablet form dosed one BID
16228823|NCT01171651|Drug|JX-594 followed by sorafenib|Patients will receive a total dose of 1e9 per treatment starting with one IV dose on Day 1 and injected intratumorally in 1-5 intrahepatic tumors on Day 8 and 22. Starting on Day 25 (3 days after the final JX-594 dose) patients will initiate oral sorafenib therapy twice daily according to standard approved guidelines. An optional maintenance JX-594 dose may be given intratumorally at Week 12 (sorafenib briefly interrupted).
16228824|NCT01171638|Device|Near infrared spectroscopy (NIRS)|Non-invasive monitoring device applied on the surface of the skin that emits harmless red light to measure tissue perfusion.
16228825|NCT01171625|Device|Implantation of CEP Magna Ease Model 3300TFX|Heart Valve Surgery
16228826|NCT01171599|Behavioral|Fit4Life|As previously described, the purpose of this study is to develop a web and text message based weight loss intervention for childhood acute lymphoblastic leukemia survivors (ALL) survivor. The web and text message based intervention that is being developed will be evaluated in a separate ACS (American Cancer Society) funded trial randomized control trial. The web and text message based intervention (there are other intervention features that do not relate to the web & text based platforms that were developed as part of this NIH funded study) is a 16-week program that includes:
16228827|NCT01171586|Behavioral|mDiet|"The goals of the intervention groups (SMS-only and SMS plus phone counseling) include: 5% weight loss, 500 k/cal per day deficit through reduced caloric intake and increased energy expenditure, 12,00 steps through the use of a pedometer, and a reduction in sedentary behaviors. Participants will receive daily pushed and pulled text messages, self-monitoring tools, and brief health promotion printed or wed materials on physical activity, nutrition, or other weight loss related topics."
16228828|NCT01171573|Procedure|Venepuncture|Venepuncture - Taking blood
16228829|NCT01171560|Procedure|endotracheal intubation|The patients will be randomized to one of two groups: EZ Blocker or conventional double lume tube. After induction of anesthesia, intubation using respective device will be performed in dorsal position.
16228830|NCT01171547|Drug|Daptomycin|once daily over 5 days
16228831|NCT01171534|Device|DermaClose fasciotomy closure|The DermaClose device provides continuous expanding of the skin around the wound until it has stretched enough to allow the skin edges to be sutured closed.
16228832|NCT01171534|Device|Vessel loop|Vessel loops and staples for fasciotomy closure
16228833|NCT01171521|Device|DermaClose Group|The DermaClose external tissue expander provides continuous expanding of the skin around a wound until it has stretched enough to suture the wound edges closed.
16228834|NCT01171508|Device|Wrist-Actigraph - Octagonal Basic Motionlogger, Ambulatory monitoring Inc, New York, USA|Wrist-Actigraph to be worn on the non-dominant arm on day 0-3-17 of the study.
16228835|NCT01171508|Device|Polysomnograph - Embla A10 (Medcare, Reykjavik, Iceland)|Polysomnography on day 0-3-17 of the study. This is a portable polysomnograph with 16 digital channels for recording of electroencephalogram (EEG), electrooculograph (EOG) and electromyograph (EMG).
16228836|NCT01171508|Device|Holter monitor - Medilog AR12 (Oxford Instruments, Oxford, England)|Holter monitoring on day 0-3-17 of the study. Measurements are done by superficial skin-electrodes placed after standardised rules from the producer of the device.
16228837|NCT01171508|Procedure|Urine 6-sulphatoxymelatonin (aMT6s)|Urine sampling for measurement of the primary metabolite of melatonin - 6-sulphatoxymelatonin (aMT6s) will be done on day 0-3-17 of the study. The analysis will be done by a radioimmunoassay.
16228838|NCT01171508|Other|Karolinska Sleepiness Scale|Karolinska Sleepiness Scale to measure sleepiness will be filled out twice a day every day of the entire study period of 17 days.
16228998|NCT01170299|Procedure|gastrointestinal complications management/prevention|
16228839|NCT01171508|Other|Visual Analog Scale and 10 point-scales to measure fatigue, general well-being, subjective sleep and pain|Visual Analog Scale and 10 point-scales to measure fatigue, general well-being, subjective sleep and pain will be filled out twice a day everyday of the study period of 17 days.
16228840|NCT01171508|Other|Sleep-diary|Sleep-diary to measure subjective sleep quantity will be completed every morning and after every nap in the day.
16228841|NCT01171495|Dietary Supplement|Theragran-M; Ensure Plus|Theragran-M: One tablet daily for 6-months. Ensure Plus: One 8 fl.oz. bottle daily for 6-months. Nutritional counselling: at baseline, and at monthly follow-up visits.
16228842|NCT01171495|Dietary Supplement|Theragran-M|Theragran-M: One tablet daily for 6-months. Nutritional counselling: at baseline and at monthly follow-up visits.
16228843|NCT01171482|Drug|5-FU|15mg/kg/day continuous IV from day 1 to day 6 every 28 days.
16228844|NCT01171482|Drug|Mitomycin|4mg/day IV push from day 1 to day 4 every 28 days
16228845|NCT01171482|Drug|sorafenib|400 mg BID every 28 days
16228846|NCT01171469|Biological|Dendritic Cells|5, 10 or 15 Million dendritic cells (DCs) - administered via intradermal injections in 0.5 ml Phosphate Buffered Saline (PBS) in the shoulders near the back of the neck to facilitate trafficking of the DCs to the cervical lymph nodes.
16228847|NCT01171469|Drug|Imiquimod|Imiquimod (INN) is a prescription medication that acts as an immune response modifier. Imiquimod is marketed as 5% Aldara cream in 250 mg packets, providing a total dose of 12.5 mg per packet and sufficient to cover 20 square centimeters. The contents of ½ of a packet will be applied as a thin film to cover approximately 10 square centimeters of skin in the area of the planned vaccination.
16228848|NCT01171456|Drug|Metformin|Administration of Metformin or placebo prior to conception to prevent the onset of GDM.
16228849|NCT01171456|Drug|Placebo|Administration of Metformin or placebo prior to conception to prevent the onset of GDM.
16228850|NCT01171430|Device|Whole Body Dynamic Contrast Enhanced MRI (WB-DCE-MRI)|"3 Whole Body Dynamic Contrast Enhanced MRI:
~1 WB-DCE-MRI before induction of chemotherapy(initial MRI).
~1 WB-DCE-MRI after induction high dose therapy and before intensification of chemotherapy and auto-transplant of hematopoietic sterns cells (early MRI).
~1 WB-DCE-MRI 3 months after treatment whatever (amendment n°3) (delayed MRI)."
16228851|NCT01171391|Drug|VA106483|1 mg VA106483 on Day 3, 2 mg VA106483 on Day 5 and 4 mg VA106483 on Day 7
16228852|NCT01171391|Other|Placebo|Placebo on Day 1
16228853|NCT01171378|Drug|Ofatumumab|"1000mg vials (50ml @ 20mg/ml), or 100mg vials (5ml @20mg/ml), to be given as an Intravenous (IV) infusion.
~Ofatumumab will be infused intravenously on day 1 (300 mg), day 8 (1000 mg) and day 15 (1000mg) in the first cycle, followed by infusions every 3 weeks of 1000 mg on the first day of each cycle for a total of 6 cycles. Maintenance treatment will start 4 weeks after day 1 of cycle 6 in week 20 and consists of six infusions of ofatumumab every 8 weeks"
16228854|NCT01171365|Drug|Ciclesonide|Inhaled ciclesonide 320mcg twice daily
16228855|NCT01171365|Drug|Placebo|Matched placebo inhaler two inhalations twice daily
16228856|NCT01171352|Procedure|Transpulmonary Thermodilution|A PiCCO femoral catheter will be placed and PiCCO parameters will be obtained using transpulmonary thermodilution after continuous dialysis is ordered or just prior to initiation of intermittent dialysis, hourly until either completion of intermittent dialysis or 8 hours of continuous dialysis is completed.
16228857|NCT01171339|Other|Optimization strategy (complex intervention)|"Healthcare assistant (HCA) and computer assisted optimization of multi-medication (complex intervention) in accordance with recommended standard#
~#Recommended standard: clinical practice guideline Geriatrie of the guideline group of Hesse (part 1 and 2)"
16228858|NCT01171326|Drug|Topical Minocycline Foam FXFM244|FXFM244 - 1%, FXFM244 - 4% to be applied twice daily during 7 days
16228859|NCT01171313|Drug|XP21279 and carbidopa (experimental)|Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed XP21279 and Carbidopa
16228860|NCT01171313|Drug|Sinemet (comparator)|Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed Sinemet.
16228861|NCT01171313|Drug|Placebo for XP21279 and carbidopa|Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed placebo for XP21279 and carbidopa
16228862|NCT01171313|Drug|Placebo for Sinemet|Eligible subjects entering the study will be randomized into 1 of 4 sequences where they will be dosed placebo for Sinemet
16228863|NCT01171300|Other|18F- FDG PET scans|We aim to investigate the value of FGD-PET for evaluating response before surgery. To achieve this, the patients will undergo 3 FDG-PET scans (at moment of diagnosis (staging), during chemoradiation (early response), 1-2 weeks before surgery (restaging))
16228864|NCT01171300|Other|DW-MRI scans|We aim to investigate the value of DW-MRI for evaluating response before surgery. To achieve this, the patients will undergo 3 FDG-PET scans (at moment of diagnosis (staging), during chemoradiation (early response), 1-2 weeks before surgery (restaging))
16228865|NCT01171287|Procedure|Driving with an Aircast Walker|
16228866|NCT01171287|Procedure|Driving with a walking cast|
16228867|NCT01171287|Procedure|Driving with a running shoe|
16228868|NCT01171274|Behavioral|Hatha Yoga|"9 weeks of Hatha Yoga, designed for treating chronic neck pain, as a group intervention.
~One class of 90 minutes per week, 10 minutes training at home each day."
16228869|NCT01171274|Behavioral|Information regarding exercises and behaviour|"9 weeks of exercises practiced at home.
~Patients receive detailed information regarding appropriate exercises and behaviour for chronic neck pain patients."
16228870|NCT01171261|Behavioral|Health Games Field Trial|There were 4 arms to the intervention in the field trial of this study. Participants were randomized to one of 4 arms or exergame that were manufactured by SSD/Xavix (Shiseido Co. of Japan). Each exergame consisted of a game cartridge, the XavixPort, and game controllers (e.g., tennis racquets, boxing gloves, bowling ball, or floor mat). The XavixPort interfaces the exergame with the participant's television and contains the infrared sensors that track the movement of the game controllers. Each exergame cartridge includes multiple game modes. The four arms/exergames were: XaviX Tennis, The Jackie Chan Studio Fitness (J-MAT), XaviX Bowling, and XaviX Boxing.
16228871|NCT01171209|Drug|Interferon-beta and human leukocyte Interferon-α|One single injection of interferon(IFN)- β and one single injection of human leukocyte IFN-α (Multiferon® ) 6 MIU s.c. with 1-7 days follow-up.
16228872|NCT01171183|Drug|controlled release carvedilol|carvedilol (Coreg CR) 80 mg/day in once daily dosing for 12 weeks followed by a 2-week taper
16228873|NCT01171183|Drug|Placebo|Placebo
16228874|NCT01171170|Drug|carboplatin paclitaxel bevacizumab|paclitaxel 200 mg/m2 d1 - carboplatin AUC 6 d1 - bevacizumab 15 mg/kg d1. Cycles every 3 weeks. Paclitaxel and carboplatin 4 cycles. Bevacizumab till progression
16228875|NCT01171170|Drug|Standard treatment plus nitroglycerin|paclitaxel 200 mg/m2 d1 - carboplatin AUC 6 d1 - bevacizumab 15 mg/kg d1. Cycles every 3 weeks. Paclitaxel and carboplatin 4 cycles. Bevacizumab till progression. Plus nitroglycerin transdermal patches 25 mg per day from day -3 till +2 of First combination cycle till the last bevacizumab monotherapy cycle
16228876|NCT01171157|Other|Routine sample collection|Collection of routine nasal/throat swab samples
16228877|NCT01171144|Other|Epidemiologic Surveillance System of the Ministry of Health of Panama|Reviewing the Epidemiologic Surveillance System of the Ministry of Health of Panama
16228878|NCT01171144|Other|Mortality database of the Contraloria General de la Republica|Reviewing the Mortality database of the Contraloria General de la Republica
16228879|NCT01171144|Other|Hospital discharge records|Reviewing the hospital discharge records
16228880|NCT01171131|Other|Blood/saliva sampling|one-time blood sample (~ 1 TBS) and saliva sample (~ 1 tsp)
16228881|NCT01171118|Drug|Physostigmine|Physostigmine is a centrally acting acetylcholinesterase inhibitor that has been proposed as a treatment for sleep disordered breathing. It is currently FDA approved and used commonly by Anesthesiologists in the post anesthetic setting to reverse confusion caused by central anticholinergic medication effects.
16228882|NCT01171118|Drug|Oxygen|The administration of nasal cannula-administered oxygen at a flow rate of 2 liters/minute is commonly performed during clinical sedation practice. Thus, this experiment employed its use to compare respiratory effects of oxygen versus room air.
16228883|NCT01171118|Drug|Placebo|The administration of placebo versus physostigmine was untertaken in the same sedation conditions on the alternate day in each subject (and with both room air and oxygen)
16228884|NCT01171105|Drug|AZD5213|oral solution, multiple ascending doses
16228885|NCT01171105|Drug|Placebo to AZD5213|
16228886|NCT01171092|Drug|bortezomib and G-CSF|"Bortezomib injection:
~1.3mg/m2 11 days before and 8 days before the stem cell collection
~G-CSF injection:
~10mcg/kg on days -4 to day -1 once daily"
16228887|NCT01171079|Device|application of oxidized regenerated cellulose|
16228888|NCT01171066|Device|Tasman CPAP system|Participants will trial the Tasman CPAP system for a duration of 1 week in place of their current CPAP system.
16228889|NCT01171053|Behavioral|Internet-delivered CBT|Internet-delivered cognitive behavioral therapy with therapist support.
16228890|NCT01171053|Behavioral|Therapist support|Weekly therapist support without CBT-interventions
16228891|NCT01171040|Other|Echocardiography, including the measurements of left atrial (LA) distensibility|The LA volumes were measured at three points: 1) immediately before the mitral valve opening (maximal LV volume or Volmax); 2) at onset of the P-wave on electrocardiography (pre-atrial contraction volume or Volp); and 3) at mitral valve closure (minimal LV volume or Volmin). The LA distensibility was calculated as (Volmax - Volmin)x 100% / Volmin. The LA ejection fraction was calculated as (Volp - Volmin)x 100% / Volp. In all patients, LA volumes were indexed to body surface area (BSA).
16228892|NCT01171027|Procedure|NOTES Cholecystectomy|The transvaginal NOTES approach is accomplished by performing a posterior colpotomy. Instead of a conventional laparoscope, a flexible endoscope is used in order to provide working channels and visualization. The gallbladder is removed through the vaginal incision. The transgastric cholecystectomy requires the flexible endoscope to be placed orally. A gastrotomy is made through the stomach wall allowing the flexible endoscope to pass into the abdominal cavity. The gallbladder is removed from the abdominal cavity into the stomach and ultimately out the mouth. The goal of NOTES is to develop further so either of these approaches will not require any incisions in the abdominal wall.
16228893|NCT01171027|Procedure|Laparoscopic Cholecystectomy|This technique utilizes the introduction of a laparoscope through a 1 cm incision in the fascia in or around umbilicus. Usually three additional 0.5- 1.0 cm incisions are employed for surgical instrumentation. Once separated from its attachments, the gallbladder is usually removed through the umbilical port. Sutures are used to close the larger port sites. The most devastating complication is injury to the major bile ducts which is avoided to the extent possible (incidence .2 to less than .01%)5 by careful visualization of the ductal structures.
16228894|NCT01171014|Dietary Supplement|Bifidobacterium lactis HN019|Bifidobacterium lactis HN019, 10 billion cfu/day, once a day for 14 days
16228895|NCT01171014|Dietary Supplement|Bifidobacterium lactis HN019|Bifidobacterium lactis HN019, 1 billion cfu/day, once a day for 14 days
16228896|NCT01171014|Dietary Supplement|Placebo|Placebo, once a day for 14 days
16228897|NCT01170988|Procedure|T-Graft|T-Graft
16228898|NCT01170975|Drug|Tesetaxel 10 mg with and then without food|Treatment Period 1: Tesetaxel 10 mg in the fed state; Treatment Period 2: Tesetaxel 10 mg in the fasted state
16228899|NCT01170975|Drug|Tesetaxel 10 mg without and then with food|Treatment Period 1: Tesetaxel 10 mg in the fasted state; Treatment Period 2: Tesetaxel 10 mg in the fed state
16228900|NCT01170962|Drug|BMS-790052|Film coated tablet, Oral, 20 mg, once daily, 24 weeks
16228901|NCT01170962|Drug|BMS-790052|Film coated Tablet, Oral, 60 mg, once daily (divided dose taken BID), 48 weeks
16228902|NCT01170962|Drug|Placebo|Film coated tablet, Oral, 0mg, Once daily, 24 weeks
16228903|NCT01170962|Drug|peginterferon alfa-2a|Solution for injection, Subcutaneous injection, 180 µg, weekly, 24 or 48 weeks
16228904|NCT01170962|Drug|ribavirin|Film coated tablet, Oral, 1,000 or 1,200 mg based on weight, divided dose taken twice a day (BID), 48 weeks
16228905|NCT01170949|Drug|Miltefosine|50 or 100 or 150mg per day
16228906|NCT01170949|Drug|Placebo|Placebo
16228907|NCT01170936|Drug|canakinumab|Single dose of canakinumab 300mg s.c. injection
16228908|NCT01170923|Device|FDR-PET|FDR-PET performed after 1 cycle of chemotherapy
16228909|NCT01170923|Device|CT|CT performed after 3 cycles of chemotherapy
16228910|NCT01170910|Procedure|Static incubation|"Kidneys in this group are conserved in University of Wisconsin (eg, UW, Belzer® or Viaspan®), IGL-1, or SCOT solution before being transplanted.
~."
16228911|NCT01170910|Procedure|Pulsatile perfusion|Kidneys in this group are placed in the pulsatile perfusion machine(RM 3) within two hours and should be kept there at least 6 hours and 8 hours if possible, before being transplanted
16228912|NCT01170897|Drug|PEGPH20|PEGylated Recombinant Human Hyaluronidase
16228999|NCT01170299|Procedure|management of therapy complications|
16228913|NCT01170884|Drug|fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution; bimatoprost 0.03% ophthalmic solution|1 drop of fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution (Combigan®) taken approximately 12 hours apart, up to 2 times a day and 1 drop of bimatoprost 0.03% ophthalmic solution (Lumigan®) taken once every 24 hours.
16228914|NCT01170884|Drug|bimatoprost 0.03% ophthalmic solution; hypromellose 0.2% eyedrops|1 drop of bimatoprost 0.03% ophthalmic solution (Lumigan®) taken approximately every 24 hours; mild lubricant eyedrops (Gen Teal® Mild) for masking purposes
16228915|NCT01170871|Drug|Ixabepilone|
16228916|NCT01170871|Drug|Pemetrexed|
16228917|NCT01170858|Drug|Icodextrin PD solution|2L of Icodextrin PD solution for long-dwell one exchange per day (at least 8 hr)
16228918|NCT01170858|Drug|glucose solutions|
16228919|NCT01170845|Drug|sivelestat sodium hydrate|saline or sivelestat sodium hydrate intravenously for 7 days starting the beginning of surgery
16228920|NCT01170819|Device|Double balloon catheter|The balloons either side of the cervix are inflated with 50 ml of water. The catheter is removed after 12 hours if spontaneous expulsion has not occurred.
16228921|NCT01170819|Drug|Dinoprostone 10 mg controlled-release vaginal insert|Vaginal insert is placed in the posterior vaginal fornix for a maximum period of 24 hours.
16228922|NCT01170806|Drug|Orlistat|Capsules of 120mg of two commercial formulations of Orlistat (Lipiblock or Xenical) were taken 3 times daily for 7 dayy
16228923|NCT01170793|Behavioral|educative telephone coaching (ETC)|a 30 to 45 minutes phone call, by appointment, by the nurse
16228924|NCT01170780|Drug|Dexamethasone|single use of dexamethasone IV 8 mg/2 ml
16228925|NCT01170780|Drug|Saline|2 ml IV
16228926|NCT01170767|Drug|Avastin|Intravitreal injection of bevacizumab at a concentration of 1.25 mg per injection. One injection per month at the maximum and between 3 and 12 injection in the whole study.
16228927|NCT01170767|Drug|Lucentis|Intravitreal injection of ranibizumab at a concentration of 0.50 mg per injection. One injection per month at the maximum and between 3 and 12 injection in the whole study.
16228928|NCT01170754|Drug|PEG-3350 and Gatorade|255 grams of miralax mixed with 64 ounces gatorade for colonoscopy preparation.
16228929|NCT01170754|Drug|Golytely 4 liters|Golytely 4 liters
16228930|NCT01170741|Behavioral|Tailored Cue Cards|The proposed intervention uses education to increase knowledge and skill building to influence behavior-specific self-efficacy and outcome expectations. In addition to providing general information regarding drug use and diseases, the cue-cards include information that is designed to raise awareness regarding perceived threats (perceived susceptibility and perceived severity) related to HIV and other STIs and blood-borne infections, which increases motivation to reduce risk behaviors. The cue-cards also provide information regarding risk reduction strategies. The cue-cards also contain instructions on how to anticipate and avoid risky situations (e.g., using alcohol or drugs prior to sex). This information is augmented with an exercise that involves modeling and guided practice. This combination of information and exercises modifies outcome expectations by increasing confidence (i.e., perceived self-efficacy) that a protective action can be performed
16228931|NCT01170728|Device|Coloplast Virtue® Male Sling|The Virtue Male sling is a class II single use implantable sub-urethral, permanent, non-absorbable, support sling indicated for the surgical treatment of male stress urinary incontinence (SUI) resulting from intrinsic sphincter deficiency (ISD). The device consists of a knitted monofilament polypropylene mesh which provides surface area for supporting the bulbous urethra. The four arms are covered with polyethylene sleeves with braided polyester sutures attached at the end of the mesh arms providing proper attachment to the introducer for positioning of the sling. The single use introducer allows for implanting both the trans-obturator arms and pre-pubic arms of the mesh sling.
16228932|NCT01170715|Drug|Etanercept|self-administered for 52 weeks
16228933|NCT01170702|Drug|0.9% Normal Saline|The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
16228934|NCT01170702|Drug|0.2% Ropivacaine|The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
16228935|NCT01170702|Drug|0.5% Ropivacaine|The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
16228936|NCT01170702|Drug|0.75% Ropivacaine|The abdominal muscle layers will be located by placing the ultrasound transducer perpendicular to the coronal anatomic plane at the T-10 dermatome level in the patient's midaxillary line. Under ultrasound guidance, a 70mm or 90mm, 21 gauge blunted Stimuplex needle will be advanced from the skin until the tip reaches the fascial layer between the internal oblique and transversus abdominis. 15ml of the study drug will be injected incrementally. The needle will then be removed and the process repeated in the same manner on the patient's opposite side.
16228937|NCT01170676|Behavioral|Puff City GA|Puff City GA focuses on three areas of health behavior: 1) adherence to controller medications; 2) immediate availability of rescue medication; 3)smoking cessation/reduction.
16228938|NCT01170676|Behavioral|General Asthma Education|Students will be directed to generic public websites on asthma and smoking that contain helpful information on general asthma management.
16228939|NCT01170663|Biological|Ramucirumab (IMC-1211B) DP|8 milligrams/kilogram (mg/kg) intravenous (IV) infusion on Days 1 and 15 of every 4-week cycle
16228940|NCT01170663|Drug|Placebo|Ramucirumab placebo IV infusion on Days 1 and 15 of every 4-week cycle
16228941|NCT01170663|Drug|Paclitaxel|Paclitaxel 80 milligrams per square meter (mg/m²) IV infusion on Days 1, 8, and 15 of every 4-week cycle
16228942|NCT01170650|Drug|EC145|IV bolus on days 1,3,5 and 15,17,19 of a 4-week cycle
16228943|NCT01170650|Drug|Pegylated Liposomal Doxorubicin (PLD/Doxil®/Caelyx®)|50 mg/m2 (calculated on the basis of ideal body weight) every 4 weeks. Dose reductions permitted for toxicity.
16228944|NCT01170650|Drug|placebo|IV bolus on days 1,3,5 and 15,17,19 of a 4-week cycle
16228945|NCT01170650|Drug|EC20|During the screening period participants will receive a single intravenous administration of EC20 prior to SPECT imaging
16228946|NCT01170637|Drug|Ibuprofen|200 mg oral administration (RhinAdvil(R))
16228947|NCT01170637|Drug|Ibuprofen|200 mg oral administration (BI product)
16228948|NCT01170637|Drug|Pseudoephedrine-HCl|30 mg oral administration (BI product)
16228949|NCT01170637|Drug|Pseudoephedrine-HCl|30 mg oral administration (RhinAdvil(R))
16228950|NCT01170624|Device|ICD|Paradym CRT model 8750 - Paradym DR model 8550 - Paradym VR model 8250
16228951|NCT01170611|Device|PACEMAKER SYMPHONY 2550|
16228952|NCT01170598|Other|Exercise|After obtaining daily medical clearance, patients will be approached 4-5 days per week to perform 30-45 minutes of supervised exercise with a Canadian Society for Exercise Physiology (CSEP) - Certified Exercise Physiologist. All exercise sessions will be as tolerated, based on patient symptoms.
16228953|NCT01170585|Drug|Rosuvastatin|All patients will be uptitrated from an initial start dose of 5mg to 20mg rosuvastatin. This will be given once a day for 2 years.
16228954|NCT01170585|Drug|Placebo|Placebo
16228955|NCT01170572|Other|No intervention|No intervention
16228956|NCT01170559|Device|Implantable Loop Recorder|
16228957|NCT01170546|Other|plate-loaded kneeling leg curl with internal rotation|The participant was instructed to point toes toward medial side as knee flexing. This is an open-kinetic chain (OKC) exercise and medial hamstring was emphasized.
16228958|NCT01170546|Other|plate-loaded squat press|The subject was instructed to position his back properly against the backrest on a machine, with the feet slightly apart. He was instructed to place his feet higher on the foot plate and draw his two knees as close as possible while the knees flexed so that medial hamstring would supposedly bear more tension in the course of knee flexion. This is a closed-kinetic chain (CKC) exercise and was expected to strengthen the quadriceps and hamstring with medial hamstring emphasized.
16228959|NCT01170546|Other|plate-loaded kneeling leg curl|An open-kinetic chain (OKC) exercise was intended to strengthen the hamstring muscle without lateralization emphasized.
16228960|NCT01170533|Drug|omeprazole and pantoprazole|The clopidogrel dose will be a 600mg loading dose followed by a 75mg daily maintenance dose, starting the next day for 7 days. Omeprazole will be used at a daily dose of 40mg and pantoprazole at 80mg.
16228961|NCT01170520|Device|repetitive transcranial Stimulation|rTMS using the figure of 8 magstim for 4 weeks or 20 work days, using 100% threshold to the LDPFC 42 trains per day 4 sec pretrain inter train interval of 30 sec.
16228962|NCT01170507|Drug|vitamin D3 1000 IU orally daily for 5 months|
16228963|NCT01170507|Drug|vitamin D3 3000 IU orally daily for 5 months|
16228964|NCT01170507|Drug|vitamin D3 5000 IU orally daily for 5 months|
16228965|NCT01170507|Drug|Placebo orally daily for 5 months|
16228966|NCT01170494|Drug|ergocalciferol 2000 IU orally, daily|ergocalciferol 2000 IU orally, daily
16228967|NCT01170494|Drug|ergocalciferol 25000 IU oraly every 2 weeks|ergocalciferol 25000 IU oraly every 2 weeks
16228968|NCT01170494|Drug|ergocalciferol 50000 IU orally every 4 weeks|ergocalciferol 50000 IU orally every 4 weeks
16228969|NCT01170494|Drug|ergocal1000 IU & cholecal 1000 IU orally daily|ergocalciferol 1000 IU and cholecalciferol 1000 IU orally every day
16228970|NCT01170494|Drug|cholecalciferol 2000 IU orally daily|cholecalciferol 2000 IU orally everyday
16228971|NCT01170494|Drug|Cholecalciferol 25000 IU orally every 2 weeks|Cholecalciferol 25000 IU orally every 2 weeks
16228972|NCT01170494|Drug|Cholecalciferol 50000 orally every 4 weeks|Cholecalciferol 50000 orally every 4 weeks
16228973|NCT01170494|Drug|placebo orally everyday|placebo orally everyday
16228974|NCT01170468|Drug|Vitamin D3|Vitamin D3 5000 IU orally, daily for 2 years
16228975|NCT01170468|Drug|Placebo|Placebo orally, daily for 2 years
16228976|NCT01170455|Device|Macintosh laryngoscope|nasal intubation with macintosh laryngoscope after general anesthesia induction
16228977|NCT01170455|Device|Blind Intubation Device|nasal intubation using Blind Intubation Device after general anesthesia induction
16228978|NCT01170442|Drug|vitamin D3 2000 IU|vitamin D3 2000 IU orally, daily for 6 months
16228979|NCT01170442|Drug|vitamin D3 5000 IU|vitamin D3 5000 IU orally, daily for 6 months
16228980|NCT01170442|Drug|Placebo|placebo orally, daily for six months
16228981|NCT01170429|Drug|Procaterol hydrochloride|25µg BID for 8 weeks
16228982|NCT01170429|Drug|Meptin placebo|25µg BID for 8 weeks
16228983|NCT01170416|Other|12-lead body surface mapping|An average of 20 distinct left ventricular sites will be mapped using 12-lead body surface mapping electrodes and recorded for 15 seconds, then sent to a computer for further analysis.
16228984|NCT01170390|Drug|All participants (Aviane)|20 mcg EE/0.1 mg LNG cyclically
16228985|NCT01170390|Drug|Portia|30 mcg EE/0.15 mg LNG cyclically
16228986|NCT01170390|Drug|Aviane|20 mcg EE/0.1 mg LNG continuously dosed
16228987|NCT01170364|Drug|Sibutramine|1 week of active sibutramine (15mg)
16228988|NCT01170364|Drug|Placebo|2 weeks of placebo
16228989|NCT01170351|Drug|Cyclosporine-A|Cyclosprorine-A will be administered to patients in group-B according to a set protocol and the patients will be followed at regular intervals with appropriate checking of clinical and para-clinical data.
16228990|NCT01170338|Drug|Varenicline 100 mg by mouth twice daily|this is an active drug to help smoking cessation
16228991|NCT01170338|Drug|control|this is the placebo that will help us maintain a blinded study
16228992|NCT01170325|Drug|Divalproex Sodium|
16228993|NCT01170325|Drug|Placebo Comparator|
16228994|NCT01170312|Biological|Autologous conditioned plasma (ACP)|ACP is not a drug as the patient's own blood plasma is re-injected into the surgical site.
16228995|NCT01170312|Other|Normal saline|Normal saline injection
16228996|NCT01170299|Dietary Supplement|dietary intervention|
16229001|NCT01170286|Biological|Whole peanut extract|Four different doses of whole peanut extract expressed as micrograms (mcg) of peanut proteins (20, 100, 250, 500 mcg) and two different dosing regimen (epicutaneous application for 24 hours every 24 hours and epicutaneous application for 48 hours every 48 hours) will be tested for determination of the maximum tolerated dose during a 2-week treatment period.
16229002|NCT01170286|Biological|Placebo formulation|Matching placebo at two different dosing regimen (epicutaneous application for 24 hours every 24 hours and epicutaneous application for 48 hours every 48 hours) will be tested in parallel to the peanut proteins doses for determination of the maximum tolerated dose during a 2-week treatment period.
16229003|NCT01170273|Dietary Supplement|vitamin D|cholecalciferol
16229004|NCT01170273|Dietary Supplement|placebo|placebo tablet
16229005|NCT01170260|Behavioral|INFORMATION-ONLY SEXUAL RISK REDUCTION (INFO-ONLY)|Intervention includes presentation of STD facts, safe sex activities, condom demonstration, video about sexual decision making, group discussion
16229006|NCT01170260|Behavioral|SEXUAL PLUS ALCOHOL RISK REDUCTION (SRRI+ETOH)|Intervention includes presentation of STD/alcohol facts, safe sex activities, condom demonstration, video about alcohol/sexual decision making, group discussion
16229007|NCT01170260|Behavioral|SEXUAL + ALCOHOL + MARIJUANA RISK REDUCTION|Intervention includes presentation of STD/alcohol/marijuana facts, safe sex activities, condom demonstration, video about alcohol/marijuana/sexual decision making, group discussion
16229008|NCT01170247|Drug|Ketamine|Intranasal Ketamine (100 mg/mL)
16229009|NCT01170247|Drug|Ketamine|Intramuscular Ketamine
16229010|NCT01170234|Device|NIOX MINO® Airway Inflammation Monitor|We will measure exhaled nitric oxide of patients with eosinophilic esophagitis pre-, during and post- treatment at pre-defined time intervals.
16229011|NCT01170221|Drug|TR-701 FA|Oral TR-701 FA 200 mg once daily for six days followed by four days of placebo.
16229012|NCT01170221|Drug|Linezolid|Oral Linezolid 600 mg twice daily for 10 days
16229013|NCT01170208|Device|insulin dose software|The rationale to conduct this study is that Hygieia hypothesizes the software will effectively and safely optimize glucose control in insulin-requiring patients with type-1 and type-2 diabetes. The software was designed to provide safe insulin dosage recommendations.
16229014|NCT01170195|Dietary Supplement|Calmera-Licorice Root Extract (Licogen)|100 mg per day
16229015|NCT01170182|Drug|Omeprazole|Omeprazole Delayed Release Capsules 40 mg
16229016|NCT01170182|Device|Prilosec® 40 mg|Prilosec® 40 mg
16229017|NCT01170169|Drug|Omeprazole|Omeprazole Delayed Release Capsules 40 mg
16229018|NCT01170169|Drug|Prilosec|Prilosec® 40 mg of Merck & Co.Inc.
16229019|NCT01170156|Device|Hi-Lo Evac tube (Mallinckrodt Inc, USA) (Instilled blue dye)|The cuff pressure will be first checked and reset at 30 cm H2O if needed. Next, blue dye will be instilled just above the cuff through the lumen ending in the subglottic area of the Hi-Lo Evac tube. Then a suctioning manoeuvre will be performed with a suction pressure of - 400 mbar through a 16 French suction catheter. Thereafter, a fiberoptic bronchoscopy will be performed, looking for the presence of blue dye in the trachea and/or the bronchi.
16229020|NCT01170143|Drug|Trastuzumab QW, Trastuzumab Q3W|two arms using Trastuzumab QW vs Q3W
16229021|NCT01170130|Drug|Lidocaine 1% (sterile)|during the phacoemulsification surgery patients will be given intracamerally lidocaine 1% (0.2 ml) and the pupil size will be recorded after 90 seconds
16229022|NCT01170117|Drug|Olanzapine|Dosing of olanzapine will begin at 2.5 mg and will be titrated to a maximum dose of 10 mg. The target dose of 10 mg of olanzapine was selected because published data from studies that used this dose indicated that it was helpful to patients.
16229023|NCT01170117|Drug|Placebo|Control Group will receive placebo pill
16229024|NCT01170104|Drug|Sorafenib|Sorafenib (NEXAVAR, Bayer) will be administered after TACE continuous dosing from day 1 until progression or up to 6 cycles of TACE as an oral 400mg twice-daily without food (at least 1 hour before or 2 hours after eating).
16229025|NCT01170104|Procedure|TACE (Transcatheter arterial chemoembolization)|Sorafenib (NEXAVAR, Bayer) will be administered after TACE continuous dosing from day 1 until progression or up to 6 cycles of TACE as an oral 400mg twice-daily without food (at least 1 hour before or 2 hours after eating).
16229026|NCT01170078|Drug|Epoetin Hospira|IV dose 3 times a week.
16229027|NCT01170078|Drug|Epogen|IV dose 3 times a week
16229028|NCT01170065|Drug|BIBF 1120|Intermediate dose BIBF 1120 twice daily
16229029|NCT01170065|Drug|BIBF 1120|High dose BIBF 1120 twice daily
16229030|NCT01170065|Drug|BIBF 1120|Low dose BIBF 1120 twice daily
16229031|NCT01170065|Drug|BIBF 1120|Low dose BIBF 1120 once daily
16229032|NCT01170052|Drug|Temsirolimus|Temsirolimus 75mg i.v. day 1, 8, 15, 21 for a 28 day cycle with a maximum of 6 Cycles.
16229033|NCT01170052|Drug|Bendamustine|Bendamustin 90mg/m2 i.v. day 2 and 3 for a 28 day cycle with a maximum of 6 Cycles.
16229034|NCT01170052|Drug|Temsirolimus|Consolidation Therapy for Patients reached CR or PR with Temsirolimus 75mg weekly until progression.
16229035|NCT01170039|Drug|Lubiprostone|Lubiprostone will be given as 24 mcg orally twice a day.
16229036|NCT01170039|Drug|Placebo|A matched placebo pill will be given twice a day for 8 weeks.
16229037|NCT01170026|Behavioral|Family Check-up/ Individual MI|The 2-session intervention protocol consists of an individual motivational interview plus the Family Check-Up (Dishion & Kavanagh, 2003), a family based motivational interview. The experimental protocol provides a thorough assessment of both individual and family strengths and weaknesses with respect to substance use prevention and school attendance/performance.
16229038|NCT01170026|Behavioral|Individual and family psychoeducation|Families in PE will return for the same number of visits as the IMI and FCU sessions of the IMI/FCU condition. An interventionist will review a set of educational materials with the parents regarding teen SU use, truancy and risk behaviors and parenting a teenager. A similar set of materials will be reviewed with the adolescent
16229039|NCT01170013|Behavioral|Family Check-up|Two session motivational intervention to improve parent monitoring and communication with respect to adolescent risk behavior especially substance use
16229040|NCT01170013|Behavioral|Parent psychoeducation|Two sessions of psychoeducation for parents regarding adolescent risk behaviors. especially substance use
16229041|NCT01169974|Other|tourniquet ischemia|Recording of cutaneous blood flow on the forearm at rest before and following tourniquet ischemias of 1 , 2 & 3 minutes
16229042|NCT01169948|Radiation|Computed tomography scan|Computed tomography will be performed using a 320 multidetector computed tomography scanner and may include coronary calcium score, coronary angiography and myocardial perfusion scanning.
16229043|NCT01169935|Drug|Administration of intra-dermal Endorem|single dose, intradermal
16229044|NCT01169935|Biological|Mantoux test|single dose, intradermal
16229045|NCT01169935|Biological|Autologous Endorem-labelled mononuclear cells|single dose, intravenous
16229046|NCT01169935|Drug|Administration of Endorem|single dose, intravenous
16229047|NCT01169922|Behavioral|SEXUAL RISK REDUCTION + ALCOHOL RISK REDUCTION|2 hour 50 minute long intervention; includes presentation of STD/HIV facts, activities/games regarding safe sex, condom demonstration, video about sexual decision making, video about alcohol/sexual decision making, alcohol-related risk-reduction motivational interview, group discussion
16229048|NCT01169922|Behavioral|INFORMATION-ONLY SEXUAL RISK REDUCTION|1 hour 30 minute long intervention; includes presentation of STD/HIV facts, video about sexually transmitted diseases, review of STD/HIV facts
16229049|NCT01169909|Drug|Ranibizumab|Subtenon injections of Ranibizumab 0.5mg will be given, and repeated twice with 30 day intervals between each dose. Note, after an amendment in February 2011, this dose was increased to 2mg with the same schedule.
16229050|NCT01169883|Behavioral|Coping Peer Support|The Coping Peer Support is delivered at weekly group meetings over the 10 week active treatment phase. The Coping Peer Support consists of: group support, coping peer group problem solving, and development and recording of Coping Peer Asthma Messages. More specifically, a social worker facilitates a peer group discussion of barriers to taking their daily inhaled steroids, and ways to overcome these barriers. The social worker also facilitates peer recording of messages by the participants encouraging each other to take their daily inhaled steroid medication.
16229051|NCT01169883|Behavioral|Doctor Asthma Messages|The attention control group will receive Doctor Asthma Messages delivered during the 10 week active treatment phase. The content and number of these messages will be equivalent to those received by the intervention group. These messages are developed and recorded by an Allergist/Immunologist. The participants in the attention control group will listen to these Doctor Asthma Messages, between their favorite music tracks on their MP3 player, as they go about their day-to-day activities.
16229052|NCT01169883|Behavioral|Coping Peer Asthma Messages|The Coping Peer Asthma Messages developed and recorded by study participants for each other at the weekly coping peer group meetings will be placed on intervention group participants' MP3 players. These Coping Peer Asthma Messages will be played on their MP3 players, between their favorite music tracks, during the course of their daily routines. This infuses the coping peer support from the coping peer group meetings into the adolescents' daily routines.
16229053|NCT01169883|Behavioral|Asthma Supervision|A member of the study team meets individually with each participant at baseline to teach proper use of a peak flow meter and spacer.
16229054|NCT01169883|Behavioral|Music Tracks|Participants receive an MP3 player (iPod Shuffle) in the baseline period. Participants receives clean, radio-edited music tracks of their choice in the baseline period and 10 week active treatment period.
16229055|NCT01169870|Drug|Genexol-PM|Treatment is given in the outpatient setting. Patients receive treatment every 3 weeks up to 6 cycles.
16229056|NCT01169870|Drug|Paclitaxel|
16229057|NCT01169857|Drug|Velcade|Velcade at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle). The study will involve 3 cycles of Velcade therapy.
16229058|NCT01169844|Biological|AIN457A|
16229059|NCT01169844|Other|Other|
16229060|NCT01169831|Other|Exercise Training|2 weeks of daily aerobic exercise training
16229061|NCT01169831|Other|Exercise Cessation|Stopping all exercise for 2 weeks
16229062|NCT01169818|Drug|Insulin Glargine|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous
~Dose regimen: initial: once a day in the evening at bedtime. Titration will occur each time the middle FPG (Fasting Plasma Glucose) value is above target"
16229063|NCT01169805|Drug|Ondansetron|Ondansetron/single injection/4 mg/IV
16229064|NCT01169805|Drug|Ramosetron|Ramosetron HCl/single injection/0.3mg/IV
16229065|NCT01169805|Drug|Palonosetron|Palonosetron HCl/single injection/0.075mg/IV
16229066|NCT01169805|Drug|Normal saline inj|normal saline injection 2ml
16229067|NCT01169792|Drug|tamoxifen|
16229068|NCT01169779|Drug|Lixisenatide (AVE0010)|Self administered by subcutaneous injections once daily within the hour preceding breakfast.
16229069|NCT01169779|Drug|Placebo|Self administered by subcutaneous injections once daily within the hour preceding breakfast.
16229070|NCT01169779|Device|Pen auto-injector|
16229071|NCT01169779|Drug|Metformin|Metformin to be continued at stable dose (at least 1.0 gram per day and not more than 1.5 gram per day) up to Week 24.
16229072|NCT01169779|Drug|Sulfonylurea|Sulfonylurea if given at screening, to be continued up to Week 24. In patients with a screening HbA1c <8% the dose is decreased by 25% to 50% at randomization and then increased up to the screening dose between Week 4 and 12 as per fasting self-monitored plasma glucose (SMPG) values. In patients with a screening HbA1c >=8%, the dose is not to be changed at randomization. In any case, after Week 12, sulfonylurea is to be continued at a stable dose.
16229073|NCT01169753|Drug|Placebo|Oral tablet every morning for 2 weeks
16229074|NCT01169753|Drug|Armodafinil|Three 50 mg tablets orally every morning for 2 weeks.
16229075|NCT01169740|Procedure|Measurement of bilirubin in blood and skin color|Blood sampling and analysis, measurement of skin color by transcutaneous bilirubinometry
16229076|NCT01169714|Drug|0.1 mg PF-04995274|0.1 mg PF-04995274, qd, for 14 days or placebo
16229077|NCT01169714|Drug|1 mg PF-04995274|1 mg PF-04995274, qd, for 14 days or placebo
16229078|NCT01169714|Drug|10 mg PF-04995274|10 mg PF-04995274, qd, for 14 days or placebo
16229079|NCT01169714|Drug|15 mg PF-04995274|15 mg PF-04995274, qd, for 14 days or placebo
16229080|NCT01169714|Drug|1.0 mg PF-04995274|1.0 mg PF-04995274, qd, for 14 days or placebo
16229081|NCT01169714|Drug|15 mg PF-04995274|15 mg PF-04995274, qd, for 14 days or placebo
16229082|NCT01169701|Drug|Everolimus|Everolimus was supplied in boxes with 60 tablets. Available tablets: 1.0 mg, 0.5 mg and 0.25 mg.
16229083|NCT01169701|Drug|Tacrolimus|Tacrolimus was administrated as Prograf® or Advagraf®, but could not be changed during study.
16229215|NCT01168726|Behavioral|Personalized Normative Feedback|Personalized feedback on how one's own drinking compares to relevant norms.
16229084|NCT01169701|Drug|Mycophenolic acid (MPA)|Myfortic® (MFS) was given as 720-1440 mg/day or 360-1440 mg/day. Cell-Cept® (MMF) was given as 1000-2000 mg/day or 500-2000 mg/day.
16229085|NCT01169688|Other|Pupil dilation with phenylephrine 10% vs cyclopentolate 2%|
16229086|NCT01169675|Drug|BIBW 2992 low dose|patient receives low dose BIBW 2992 po daily on day 1 of 21 day cycle
16229087|NCT01169675|Drug|BIBW 2992 high dose|patient receives high dose BIBW 2992 po daily on day 1 of 21 day cycle
16229088|NCT01169675|Drug|pemetrexed|given intravenously on day 1 of a 21 day cycle
16229089|NCT01169675|Drug|pemetrexed|given intravenously on day 1 of a 21 day cycle
16229090|NCT01169675|Drug|BIBW 2992 high dose 6 day|patient receives high dose BIBW 2992 po daily on days 1-6 on 1 of 21 day cycle
16229091|NCT01169675|Drug|pemetrexed|given intravenously on day 1 of a 21 day cycle
16229092|NCT01169675|Drug|pemetrexed|given intravenously on day 1 of a 21 day cycle
16229093|NCT01169675|Drug|pemetrexed|given intravenously on day 1 of a 21 day cycle
16229094|NCT01169675|Drug|pemetrexed|given intravenously on day 1 of a 21 day cycle
16229095|NCT01169675|Drug|BIBW 2992 low dose 6 day|patient receives low dose BIBW 2992 po daily on days 1-6 on day 1 of 21 day cycle
16229096|NCT01169675|Drug|BIBW 2992 medium dose 6 day|patient receives medium dose BIBW 2992 po daily on day1 to 6 of a 21 day cycle
16229097|NCT01169675|Drug|BIBW 2992 medium dose|patient receives medium dose BIBW 2992 po daily on day 1 of 21 day cycle
16229098|NCT01169662|Dietary Supplement|Vegetable/fruit juice|450ml active juice, 45ml no added sugar fruit squash (for flavour)
16229099|NCT01169662|Dietary Supplement|Placebo juice|50 ml No Added Sugar fruit squash, 45 ml Pressed Apple Juice, 405ml with water.
16229100|NCT01169649|Drug|MK-2206|MK-2206 will be given orally 200 mg qw as given in the prior Ph1 clinical trial that demonstrated safety, tolerability and adequate PK/PD values at this dose. Follow-up imaging scans will be performed every 12 weeks to evaluate response. Patients must take MK-2206 orally at least 2 hours before or 2 hours after food or a meal.
16229101|NCT01169636|Drug|Panobinostat|Starting Day -6 of Cycle 1, 20 mg orally on Monday, Wednesday, and Friday during Cycles 1 and 2 (Days -6, -4, and -2 of Cycle 1 and Days 1, 3, 5, 8, 10, and 12 of Cycles 1 and 2); MTD found in Phase 1 used for same schedule in Phase 2.
16229102|NCT01169636|Drug|Ifosfamide|Day 1 of Cycles 1-3, 5 grams/m2 by vein over 24 hours.
16229103|NCT01169636|Drug|Mesna|On Day 1 of Cycles 1-3, 2 grams/m2 by vein over 12 hours.
16229104|NCT01169636|Drug|Carboplatin|On Day 1 of Cycles 1-3, Standard Dose (Target area under curve (AUC) = 5mg/ml/min) by vein over 1 hour.
16229105|NCT01169636|Drug|Etoposide|On Days 1-3 of Cycles 1-3, 100 mg/m2 by vein over 2 hours.
16229106|NCT01169636|Drug|Pegfilgrastim|Beginning Day 4 of Cycles 1-3, 6 mg under the skin.
16229107|NCT01169623|Other|Assessing the Effect Of Educational Intervention Based On Supportive Leadership Behavior on Iranian head nurses leadership performance|55 of head nurses who will participate in educational Intervention arm based on supportive leadership behaviour model
16229108|NCT01169610|Drug|Varenicline|Varenicline is an oral medication with a recommended dosage of 0.5 mg once daily for 3 days, increasing to 0.5 mg twice daily for days 4 to 7, and then to the maintenance dose of 1 mg twice daily for the remaining 23 weeks of treatment. All subjects will receive open-label varenicline in blister packs.
16229109|NCT01169597|Drug|prednisone|prednisone 12.5 mg daily po
16229110|NCT01169584|Drug|Recombinant Vaccinia GM-CSF; RAC VAC GM-CSF (JX-594)|Intratumoral Injection Dosage from 1 x 10^6 pfu/kg to 3 x 10^7 pfu/kg is administered once to 1-3 injectable tumors in pediatric patients.
16229111|NCT01169571|Drug|Dexmedetomidine|
16229112|NCT01169558|Drug|Bevacizumab|5 mg/kg bevacizumab administered intravenously every 2 weeks or 7.5 mg/kg bevacizumab administered intravenously every 3 weeks according to the standard chemotherapy regimen.
16229113|NCT01169558|Drug|Fluoropyrimidine-based Chemotherapy|Fluoropyrimidine-based chemotherapy administered according to standard of care.
16229114|NCT01169532|Drug|ridaforolimus|Given PO
16229115|NCT01169532|Drug|vorinostat|Given PO
16229116|NCT01169532|Procedure|biopsy|Optional correlative studies
16229117|NCT01169532|Other|pharmacological study|Correlative studies
16229118|NCT01169532|Other|laboratory biomarker analysis|Correlative studies
16229119|NCT01169519|Drug|Sildenafil by injection|Sildenafil 0.125mg/kg injection over 20min
16229120|NCT01169519|Drug|Sildenafil by injection|Sildenafil 0.25mg/kg injection over 20min
16229121|NCT01169519|Drug|Sildenafil by injection|Sildenafil 0.35mg/kg by injection over 20min
16229122|NCT01169519|Drug|Sildenafil by injection|Sildenafil 0.45mg/kg by injection over 20min
16229123|NCT01169506|Device|sublingual silicon capillary|Stable patients with COPD and healthy individuals were asked to open their mouth and a small butterfly silicon capillary was placed sublingually. After 15 minutes, while the mouth was closed completely and nose breathing was performed, the capillary system was connected to a capnometer and sublingual tonometric PCO2 was measured. At the same time, PETCO2 was also measured and arterial blood was drawn for pH, PO2 and PCO2 analysis
16229124|NCT01169493|Device|VVI-40|Pacing mode set to VVI-40, RV only pacing
16229125|NCT01169493|Device|RV DDD-40|ICD programmed to DDD-40, RV only pacing with aan AV interval producing QRS fusion on surface EKG.
16229126|NCT01169493|Device|BiV DDD-40|ICD programmed to BiV pacing at a lower rate of 40
16229127|NCT01169480|Behavioral|Give a massage|Participants in this arm will give a 50-minute Swedish massage to a volunteer.
16229128|NCT01169467|Drug|Standard-of-Care plus Dexmedetomidine|Subjects who are treated with dexmedetomidine (Precedex) in addition to the standard of care sedation regiment
16229129|NCT01169467|Other|Standard-of-Care|Subjects who are treated with the standard of care sedation regiment only.
16229180|NCT01169038|Drug|levaquin; ethambutol; rifampin and azithromycin.|"Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg po QD Azithromycin 500mg on day 1, then 250 mg po QD
~**Rifampin 10 mg/kg for a maximum of 600mg po QD or Rifabutin 10 mg/kg for a maximum of 300 mg po QD. **We will not use both, but either one or the other based upon if the patient is on other medications that are metabolized by the cytochrome P450 pathway."
16229216|NCT01168726|Behavioral|Alcohol Education|Educational information about harms associated with heavy drinking.
16229673|NCT01165112|Drug|Bendamustine Hydrochloride|Given IV
16229130|NCT01169428|Behavioral|Mindfulness Based Weight Loss Maintenance (MBWLM)|This mindfulness-meditation based intervention is designed to increase awareness of the factors that affect weight loss maintenance after successful weight loss. Mindfulness meditation is a technique for training awareness. The program will train subjects to increase awareness of the somatic, cognitive, affective, interpersonal and environmental factors that mediate eating and physical activity by incorporating empirically-supported and theoretically-synergized components, including: general mindfulness meditation skills, mindful and intuitive eating, appetite-satiety awareness, mindful movement and yoga, a mindful approach to exercise engagement, and training in enhancing emotion regulation and stress management skills. In addition, the MBWLM group will be supported by Maintenance Partners who are trained as Integrative Health Coaches.
16229131|NCT01169428|Behavioral|Behavioral: Standard Behavioral Weight-Loss Maintenence|Attention/Education/Support Control group, designed to control for educational content as well as nonspecific treatment factors [e.g., natural history (time), amount of time and energy spent in the intervention, attention by group leaders, social support, as well as information & education]. Like the experimental group(MBWLM), this group meet once a week for 2 hours during the 12-week intervention, and then at 4 weeks, 8 weeks, and 12 weeks post the 12 week intervention. Participants also receive the same amount of telephonic support through Maintenance Partners as the experimental group, but their Maintenance Partners employed empathic listening only rather than myriad coaching techniques.
16229132|NCT01169415|Drug|Dexamethasone acetate|Participants will receive a protracted (30 days) course of dexamethasone after surgery.
16229133|NCT01169415|Drug|Dexamethasone|Participants will receive a protracted (14 days) course of dexamethasone after surgery.
16229134|NCT01169402|Drug|Fluconazole|25mg/kg intravenously once weekly while on ECMO
16229135|NCT01169389|Procedure|Intraarticular injection|Durolane, one vial
16229136|NCT01169389|Procedure|Intra-articular injection of 0.5% Bupivacaine|
16229137|NCT01169376|Genetic|DNA analysis|
16229138|NCT01169376|Genetic|DNA methylation analysis|
16229139|NCT01169376|Genetic|RNA analysis|
16229140|NCT01169376|Genetic|comparative genomic hybridization|
16229141|NCT01169376|Genetic|mutation analysis|
16229142|NCT01169376|Genetic|polymorphism analysis|
16229143|NCT01169363|Genetic|proteomic profiling|
16229144|NCT01169363|Other|flow cytometry|
16229145|NCT01169363|Other|laboratory biomarker analysis|
16229146|NCT01169350|Radiation|fludeoxyglucose F 18|Undergo 18F FDG and 18F FMISO PET/CT scans
16229147|NCT01169350|Other|18F-fluoromisonidazole|Undergo 18F FDG and 18F FMISO PET/CT scans
16229148|NCT01169350|Procedure|positron emission tomography|Undergo 18F FDG and 18F FMISO PET/CT scans
16229149|NCT01169350|Procedure|computed tomography|Undergo 18F FDG and 18F FMISO PET/CT scans
16229150|NCT01169350|Other|laboratory biomarker analysis|Correlative studies
16229151|NCT01169337|Other|Clinical Observation|Undergo observation
16229152|NCT01169337|Drug|Lenalidomide|Given PO
16229153|NCT01169324|Other|Alteration of DBS stimulator settings|Alteration of DBS stimulator settings
16229154|NCT01169311|Device|Hemorrhoidopexy|
16229155|NCT01169298|Drug|Lenalidomide|Lenalidomide: 25mg daily on day 1-21 of each 28days cycle (1st cohort), 25 mg daily of each 28 days (2nd cohort, or 35 mg daily of each 28 days (3rd cohort)
16229156|NCT01169272|Device|CRT-SonR 9770|Active implantable defibrillator with capacity of cardiac resynchronization therapy
16229157|NCT01169259|Dietary Supplement|vitamin D3|Vitamin D3 (cholecalciferol), 2000 IU per day.
16229158|NCT01169259|Drug|omega-3 fatty acids (fish oil)|Omacor, one 1-gram capsule per day. Each capsule of Omacor contains 840 milligrams of marine omega-3 fatty acids (465 mg of eicosapentaenoic acid [EPA] and 375 mg of docosahexaenoic acid [DHA]).
16229159|NCT01169259|Dietary Supplement|Vitamin D3 placebo|Vitamin D placebo
16229160|NCT01169259|Dietary Supplement|Fish oil placebo|Fish oil placebo
16229161|NCT01169233|Device|Bright Light Box|Increased lighting used during night shifts to prevent sleepiness.
16229162|NCT01169220|Drug|Go-Lytely|Bowel cleansing agent
16229163|NCT01169220|Drug|Go Lytely|Bowel cleansing agent
16229164|NCT01169181|Device|AMES + brain stimulation|Stroke survivors with plegia of affected upper extremity receive either AMES + rTMS or AMES + tDCS.
16229165|NCT01169155|Other|Smoke Alarm Stimuli|See arm descriptions for information about the smoke alarm stimuli interventions.
16229166|NCT01169142|Dietary Supplement|Vitamin D3|50,000 units of Vitamin D3 weekly
16229167|NCT01169142|Dietary Supplement|Vitamin D3|Vitamin D3 50,000 units weekly
16229168|NCT01169129|Other|surgery|resection of brain metastases
16229169|NCT01169129|Radiation|radiosurgery|radiosurgery to brain metastases
16229170|NCT01169116|Radiation|hypofractionated stereotactic radiotherapy|hypofractionated stereotactic radiotherapy with 4 fractions of 7 Gy at the periphery of the brain metastasis with 3 mm margin.
16229171|NCT01169103|Drug|recombinant human growth hormone (rhGH)|Initial rhGH dose 0.4mg administered by subcutaneous injection daily. Dose will be increased to 0.6 mg after one week and then increased to 0.8mg after two weeks.
16229172|NCT01169103|Drug|Placebo|Placebo will be administered by daily subcutaneous injections. Sham increases will be used.
16229173|NCT01169090|Drug|SK-0403|SK-0403
16229174|NCT01169090|Drug|Placebo|Placebo
16229175|NCT01169090|Drug|Sitagliptin|Sitagliptin
16229176|NCT01169077|Drug|Placebo|Injections of normal saline to be used as control; given at Days 0, 28, and 56. Administered via electroporation, using a DNA vaccine delivery device, in the deltoid.
16229177|NCT01169077|Biological|EP-1300|Single DNA plasmid dissolved in phosphate-buffered saline (PBS). Dose levels: 0.25, 1 and 4 mg based on DNA content, administered on Days 0, 28 and 56 via electroporation using a DNA vaccine delivery device, in the deltoid.
16229178|NCT01169064|Device|Silver-containing surgical dressing|Dressing placed over surgical incision and remain for 3-5 days
16229179|NCT01169064|Device|Cloth adhesive dressing|Cloth adhesive dressing placed over surgical incision and remains for 3-5 days
16229213|NCT01168739|Dietary Supplement|Placebo|Placebo, performed on same subjects as Quercetin Arm, used to compare results between conditions
16229214|NCT01168726|Behavioral|Protective Behavioral Strategies|Personalized feedback on use of protective behavioral strategies.
16229181|NCT01169025|Drug|Ketamine|Subjects receive 0.3 mg/kg IV ketamine over 5 minutes and are evaluated every 10 minutes. Residual or recurring pain will be treated as needed with adjunctive open-label bolus dosing of IV fentanyl (1 mcg/kg) followed by repeat boluses as needed every 10 minutes during the flight. For this open-label portion of the flight, subjects are asked if they need additional pain medication every 10 minutes, unless an earlier, spontaneous request is made by the subject or the provider determines that more is needed. For the potential of rare ketamine side effects (dysphoria, anxiety, or agitation), 2 mg IV midazolam is given every 5 minutes as needed for any of these symptoms. Vital signs are measured continuously throughout the protocol. Blood pressure is measured at 5 minute intervals.
16229182|NCT01169025|Drug|Fentanyl|Subjects receive 1 mcg/kg IV fentanyl over 5 minutes. After first dose administration, subjects are evaluated every 10 minutes. Residual or recurring pain is treated as needed with adjunctive open-label bolus dosing of IV fentanyl (1 mcg/kg) followed by repeat boluses as needed every 10 minutes during the flight. For this open-label portion of the flight, flight nurses will query participants regarding their desire for additional pain medication every 10 minutes unless an earlier, spontaneous request is made by the participant or the provider determines that more is needed. Vital signs are measured continuously throughout the protocol. Blood pressure is measured at 5 minute intervals.
16229183|NCT01169012|Drug|Clofarabine|Intravenous Clofarabine (10mg/m2) Oral clofarabine (30mg/m2) Cimetidine (800mg)
16229184|NCT01168999|Other|spinal manipulation|Spinal manipulation commonly used in the treatment of low back pain and known to be effective for some individuals experiencing low back pain
16229185|NCT01168999|Other|sham spinal manipulation|Sham spinal manipulation intended to mimic the studied spinal manipulation
16229186|NCT01168999|Other|Enhanced sham spinal manipulation|"Sham spinal manipulation intended to mimic the studied spinal manipulation and provided with the instructions, The manual therapy technique you will receive has been shown to significantly reduce low back pain in some people"
16229187|NCT01168986|Other|Pulstar Multiple Impulse Therapy|Use of the PulStar Multiple Impulse Therapy (Sense Technology). A mechanical manual therapy device.
16229188|NCT01168986|Other|Exercise|Participants perform an exercise to strengthen the deep neck flexors
16229189|NCT01168973|Biological|Ramucirumab|10 milligrams per kilogram (mg/kg) administered intravenously (IV) on Day 1 of 21-day cycle until disease progression, unacceptable toxicity, or another withdrawal criterion is met
16229190|NCT01168973|Drug|Placebo (for Ramucirumab)|Administered IV on Day 1 of 21-day cycle until disease progression, unacceptable toxicity, or another withdrawal criterion is met
16229191|NCT01168973|Drug|Docetaxel|75 milligrams per square meter (mg/m^2) (60 mg/m^2 for the countries of Korea and Taiwan only with protocol amendment dated 22 May 2012) administered IV on Day 1 of 21-day cycle until disease progression, unacceptable toxicity, or another withdrawal criterion is met
16229192|NCT01168960|Behavioral|Cognitive behavioral therapy for alcohol dependence|12-session behavioral treatment that incorporates behavioral skills training targeting high-risk drinking behavior.
16229193|NCT01168947|Other|5% dextrose solution|The extracorporeal circuit of the dialysis machine will be primed and rinsed with a 5% dextrose solution instead of 0.9% saline.
16229194|NCT01168934|Drug|crizotinib|Treatment A: Intravenous dose of 50 mg crizotinib will be administered as directed.
16229195|NCT01168934|Drug|crizotinib|Treatment B: Oral dose of 250 mg crizotinib as 1 × 50-mg Immediate Release Tablet and 2 × 100-mg Immediate Release Tablets will be administered in the fasted state as directed.
16229196|NCT01168921|Drug|Eltrombopag|Starting dose 75 mg by mouth (PO) daily for 28 day cycle
16229197|NCT01168908|Drug|Sildenafil|20mg tablet three times daily
16229198|NCT01168895|Drug|Cipro Inhale (Ciprofloxacin, BAYQ3939)|32.5 mg ciprofloxacin corresponding to 50 mg Ciprofloxacin Pulmosphere inhalation powder will be given as single dose inhalation
16229199|NCT01168895|Drug|Cipro Inhale (Ciprofloxacin, BAYQ3939)|48.75 mg ciprofloxacin corresponding to 75 mg Ciprofloxacin Pulmosphere inhalation powder will be given as single dose inhalation
16229200|NCT01168882|Drug|RGB-286638|The starting dose is a flat-fixed dose of 40 mg given i.v. over 60 min, weekly x3, of a 28-days cycle (q4 weeks)
16229201|NCT01168843|Other|computerized analysis of sonographic images|Evaluation of the Symmetry between the Primary Sulci of the Two Fetal Brain Hemispheres Using 3-dimensional Ultrasound Planes
16229202|NCT01168830|Device|AMS-3.0|
16229203|NCT01168817|Drug|BAY60-4552 plus Vardenafil|Treatment with 3 tablets once daily for 4 weeks (Vardenafil 10 mg plus BAY60-4552 1.0 mg)
16229204|NCT01168817|Drug|Vardenafil|Treatment with 3 tablets once daily for 4 weeks (Vardenafil 20 mg)
16229205|NCT01168817|Drug|Placebo|Treatment with 3 tablets once daily for 4 weeks (Placebo)
16229206|NCT01168804|Drug|bendamustine plus bortezomib plus dexamethasone|Bendamustine 70 mg/m2 on days 1+4 Velcade 1.3 mg/m2 on days 1,4,8,11 Dexamethasone 20 mg on days 1,4,8 and 11 Repeated every 4 weeks
16229207|NCT01168791|Drug|doxorubicin in combination with palifosfamide-tris|"palifosfamide-tris: 150 mg/m2 3 days every 21 days for a maximum of 6 cycles.
~doxorubicin: 75 mg/m2 1 day every 21 days for a maximum of 6 cycles."
16229208|NCT01168791|Drug|doxorubicin in combination with placebo|"doxorubicin: 75 mg/m2 of doxorubicin 1 day every 21 days for a maximum of 6 cycles.
~placebo: 250 mL of normal saline 3 days every 21 days for a maximum of 6 cycles."
16229209|NCT01168778|Behavioral|Physician Workshop|Physicians that were assigned to the intervention group attended a 3.5 hour intervention workshop where they were trained in skills to communicate information about physical examination findings, treatment, and follow-up that will ultimately facilitate appropriate antibiotic prescribing and increase parent satisfaction with care.
16229210|NCT01168765|Behavioral|Tu Salud Si Cuenta Behavioral Intervention|A behavioral intervention to assess the impact of the TSSC Media Campaign intervention outreach components with two study arms. The first arm is comprised of participants enrolled in the TSSC Media Campaign(control group) and the second arm(intervention group)consisting of participants exposed to media campaign who will be exposed to additional outreach efforts by monthly visits from lay health workers.
16229211|NCT01168752|Drug|Debio 0932|"Gelatin capsules of 2 dosage strengths (25 mg or 100 mg) The maximum dose will depend on the number of dose levels necessary to determine the MTD.
~In both schedules the study treatment will be continued, until one of the study treatment discontinuation criteria is met."
16229212|NCT01168739|Dietary Supplement|Quercetin|2g/d dietary quercetin supplementation, 1g taken am; 1g taken pm
16229217|NCT01168713|Drug|Levofloxacin|"Levofloxacin once daily for 5 days:
~Levofloxacin 750 mg PO Days 1-5"
16229218|NCT01168713|Drug|CEM-101|"CEM-101 once daily for 5 days:
~CEM-101 800 mg PO Day 1
~CEM-101 400 mg PO Days 2-5"
16229219|NCT01168700|Drug|aged garlic extract|Aged garlic extract, 1.2 g per day for 12 weeks
16229220|NCT01168700|Drug|Placebo|Placebo 1.2 g per day for 12 weeks.
16229221|NCT01168687|Drug|Levetiracetam (Keppra)|"Group A: Twenty moderate to heavy social alcohol users will receive 250 mg of levetiracetam BID (500 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 500 mg of levetiracetam BID (1,000 mg/day) x 7 days.
~Group B: Twenty moderate to heavy social alcohol users will receive 500 mg levetiracetam BID (1000 mg/day) or placebo x 7 days and will be titrated to a maximum dose of 1000 mg levetiracetam BID (2,000 mg per day) x 7 days."
16229222|NCT01168687|Drug|Placebo|
16229223|NCT01168674|Drug|ziprasidone|Ziprasidone will be administered as a pill. The once-daily total daily dose will be 80-160 mg/d of ziprasidone. Dosing will begin at 20 mg BID with an escalation strategy based on target symptoms and tolerability, with a target dose range of 80-160 mg/d. Dose escalations will occur by increments of 20-40 mg weekly.
16229224|NCT01168674|Drug|Sugar pill|The once-daily total daily dose will be 80-160 mg/d of the sugar pill. Dosing will begin at 20 mg BID with an escalation strategy based on target symptoms and tolerability, with a target dose range of 80-160 mg/d. Dose escalations will occur by increments of 20-40 mg weekly.
16229225|NCT01168661|Behavioral|Yoga|Participants in this intervention arm will practice yoga (physical postures, breathing exercises, and meditation) >= 5 times a week (twice in a supervised group and the rest on their own). Additionally, participants in this arm will practice various practical skills, such as how to plan a satisfactory day using their own definition of a satisfactory day. They will follow this schedule for 20 weeks.
16229226|NCT01168661|Behavioral|Mindfulness based cog psychotherapy|Participants in this arm will attend a weekly group meeting to practice mindfulness based cognitive psychotherapy. They will also practice >= 4 time a week on their own. Additionally, participants in this arm will practice various practical skills, such as how to plan a satisfactory day using their own definition of a satisfactory day. Participants will follow this schedule for 20 weeks.
16229227|NCT01168661|Behavioral|Cognitive psychotherapy|Participants in this arm will attend a weekly group meeting to practice cognitive psychotherapy. They will also practice >= 4 time a week on their own. Additionally, participants in this arm will practice various practical skills, such as how to plan a satisfactory day using their own definition of a satisfactory day. Participants will follow this schedule for 20 weeks.
16229228|NCT01168648|Behavioral|Yoga as stress management|Yoga specially designed to reduce stress is practiced for approximately 30 minutes at least three times a week for three months, once in a group session led by a trained yoga instructor and twice or more at home. The yoga techniques used are physical postures or movements, meditation and breathing exercises. Every time they do the techniques, participants fill in a form detailing how they feel before and after and providing information on the experience of doing the exercises.
16229229|NCT01168648|Other|Rest without using any relaxation technique|The participants rest at home at least 30 minutes, at least three times a week for three months and without using any relaxation technique
16229230|NCT01168635|Behavioral|Spirometry 360 program - Virtually-delivered spirometry quality improvement program|"The Spirometry 360 program includes:
~Spirometry Fundamentals™: A basic guide to lung function testing, a computer-based training program that teaches primary care providers how to coach patients to produce high-quality spirometry tests and accurately interpret spirometric data;
~Spirometry Learning Lab: Case-based teaching of spirometry in practice guides test administrators and interpreters through clinical examples in an interactive virtual classroom setting. These sessions are led by expert clinical faculty and are archived for future reference and review;
~Spirometry Feedback: Tailored analysis of providers' spirometry testing sessions offers monthly individualized feedback reports by clinical experts on spirometry tests performed in the clinic."
16229231|NCT01168609|Procedure|Primary percutaneous coronary intervention|Primary percutaneous coronary intervention (PCI) and stenting were performed for just the culprit lesion using standard techniques and bare-metal stents in all patients. Unfractionated heparin was used for 3 days after PCI, except in some cases with contraindications, and the dose of unfractionated heparin was selected to prolong the activated partial thromboplastin time by 2-3 times. The decision to use glycoprotein IIb/IIIa inhibitors was left to the discretion of the treating physician. The measurements of LVFP were performed via a fluid-filled pig-tail catheter placed into the LV after coronary angiography if PCI was not indicated or after primary PCI.
16229232|NCT01168596|Drug|Rasagiline|"Comparison of Rasagiline versus placebo.
~Rasagiline tablet, 1 mg, 1 per day, duration is approximately 12 weeks."
16229233|NCT01168596|Drug|Placebo|Comparison of Rasagiline versus placebo. Placebo tablet, 1 per day, duration is approximately 12 weeks.
16229234|NCT01168557|Device|EIT (Electrical Impedance Tomography)|EIT measurement; concomitant to stress echocardiography (about 45 minutes) EIT measurements (1 minute) are performed at rest, at low dobutamine stress, at peak and at relaxation
16229235|NCT01168544|Dietary Supplement|loading dose Vitamin D and 50.000 IU vit D3/month|loading dose based on body weight and baseline serum 25(OH)D level + 50.000 IU vit D3/month consolidation therapy
16229236|NCT01168544|Dietary Supplement|loading dose and 25.000 IU vit D3/month|loading dose based on body weight and baseline serum 25(OH)D level + 25.000 IU vit D3/month consolidation therapy
16229237|NCT01168544|Dietary Supplement|Vitamin D 800 IU /day|800 IU vit D3/day
16229238|NCT01168531|Drug|Pregabalin|pregabalin: 300 mg/day, po, from operative day until third postoperative day.
16229239|NCT01168531|Drug|dexamethasone|Dexamethasone 16 mg, intravenous, before induction of anesthesia
16229240|NCT01168531|Drug|placebo|vitamin B complex formula
16229241|NCT01168505|Drug|ferric hydroxide saccharate|single dose of 200 mg (2 ampoules), 24-48 hours after administration of chemotherapy for a total of four doses
16229242|NCT01168492|Drug|ketamine|0.5mg/kg ketamine iv
16229243|NCT01168479|Radiation|FLAME boost|In the experimental arm patients receive in addition to the current gold standard of 77 Gy to the prostate an integrated boost to the macroscopically visible tumour to reach a total dose of 95 Gy in 35 fractions of 2.7 Gy, 5 times per week.
16229244|NCT01168479|Radiation|standard arm|The standard arm receives the current gold standard, namely 77Gy to the prostate in 35 fractions of 2.2 Gy, 5 times per week.
16229674|NCT01165112|Drug|Carboplatin|Given IV
16229245|NCT01168466|Behavioral|QEEG-based Neurofeedback Training|EEG amplitude is measured and visual and auditory rewards are given when amplitude at specific locations is modified to meet preset threshholds.
16229246|NCT01168453|Behavioral|head position change|AL-US distance measure using the ultrasound in two different head position
16229247|NCT01168440|Drug|Sunitinib|Sunitinib, 50 mg PO daily, 6 weeks courses with schedule 4/2 (4 weeks of treatment followed by 2 weeks of rest).
16229248|NCT01168427|Device|Reveal® DX or Reveal® XT Insertable Cardiac Monitor|Reveal® DX and Reveal® XT Insertable Cardiac Monitors are implantable patient-activated and automatically-activated monitoring systems that record subcutaneous ECG.
16229249|NCT01168414|Drug|Ganfort|Fixed combination of Bimatoprost and Timolol (BTFC; Ganfort (300 microgram + 5 mg/ml eyedrops solution)
16229250|NCT01168414|Drug|Duotrav|Fixed combination of Travoprost and Timolol (TTFC; Duotrav (40 micrograms + 5 mg/ml eyedrops solution)
16229251|NCT01168401|Biological|NoV GI.1/GII.4 Bivalent VLP Vaccine|"2 Doses 28 days apart Cohort A: 18-49 Years
~Cohort A1: IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (5/5 mcg)
~Cohort A2: IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (15/15 mcg)
~Cohort A3: IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (50/50 mcg)
~Cohort A4: IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (150/150 mcg)
~Cohort B: 50-64 Years IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (50/50 mcg)
~Cohort C: 65-85 Years IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (50/50 mcg)
~Cohort D: 18-49 Years IM Norovirus Bivalent GI.1/GII.4 VLP Vaccine (50/50 mcg)"
16229252|NCT01168401|Biological|Saline|Two doses 28 days apart
16229253|NCT01168375|Drug|conventional therapy plus umbilical cord serum eye drop|chloramphenicol and betamethasone eye drops every 6 hours, cycloplegic (homatropine) eye drop every 8 hours plus umbilical cord serum eye drop 20% every 4 hours
16229254|NCT01168375|Drug|conventional therapy|chloramphenicol and betamethasone eye drops every 6 hours, cycloplegic (homatropine) eye drop every 8 hours
16229255|NCT01168349|Drug|epoetin beta [NeoRecormon]|As prescribed by physician
16229256|NCT01168336|Drug|Betahistine standard formulation|betahistine 24 mg tablets
16229257|NCT01168336|Drug|Betahistine Extended Release formulation|betahistine 32 mg tablets
16229258|NCT01168336|Drug|Placebo|matching placebo
16229259|NCT01168323|Behavioral|Online spaced education|Spaced education is currently delivered via periodic emails that contain clinical case scenarios and multiple-choice questions. Upon submitting answers to each question online, clinicians receive immediate feedback and educational material. The questions are then repeated over spaced intervals of time to harness the pedagogical benefits of the spacing effect.
16229260|NCT01168310|Drug|Fluticasone Propionate/Formoterol Fumarate|Inhalation Suspension
16229261|NCT01168310|Drug|Fluticasone Propionate/Formoterol Fumarate|Inhalation Suspension
16229262|NCT01168310|Drug|Fluticasone Propionate/Formoterol Fumarate|Inhalation Suspension
16229263|NCT01168310|Drug|Fluticasone Propionate/Formoterol Fumarate|Inhalation Suspension
16229264|NCT01168310|Drug|Fluticasone Propionate/Formoterol Fumarate|Inhalation Suspension
16229265|NCT01168310|Drug|Formoterol Fumarate|Inhalation Solution
16229266|NCT01168310|Drug|Placebo|Inhalation Solution
16229267|NCT01168284|Behavioral|Coping Effectiveness Training|
16229268|NCT01168245|Device|Sham-NICE-System|sham TMS and sham cognitive training
16229269|NCT01168245|Device|NICE-System|TMS combined with cognitive training
16229270|NCT01168232|Drug|Ixabepilone|Given IV
16229271|NCT01168232|Other|Laboratory Biomarker Analysis|Correlative studies
16229272|NCT01168219|Procedure|Allogeneic Hematopoietic Stem Cell Transplantation|Undergo allogeneic hematopoietic stem cell transplantation
16229273|NCT01168219|Biological|Anti-Thymocyte Globulin|Given IV
16229274|NCT01168219|Drug|Azacitidine|Given SC or IV
16229275|NCT01168219|Drug|Busulfan|Given IV
16229276|NCT01168219|Drug|Fludarabine Phosphate|Given IV
16229277|NCT01168219|Other|Laboratory Biomarker Analysis|Correlative studies
16229278|NCT01168219|Drug|Methotrexate|Given IV
16229279|NCT01168219|Other|Pharmacological Study|Correlative studies
16229280|NCT01168219|Drug|Tacrolimus|Given PO or IV
16229281|NCT01168206|Dietary Supplement|TK3|Tritofano 160mg / Timina140mg and starch 150 mg
16229282|NCT01168206|Dietary Supplement|1 capsule, 3 times per day|Placebo
16229283|NCT01168193|Other|No intervention|
16229284|NCT01168180|Other|Traditional Thai massage|The participants will receive thirty minutes session of traditional Thai massage onto the scapular region for 9 sessions over a period of 3 weeks
16229285|NCT01168180|Other|Ultrasound therapy and hot pack|
16229286|NCT01168154|Dietary Supplement|Lactobacillus Reuterii|Lactobacillus Reuterii 10000000000 CFU per day
16229287|NCT01168154|Dietary Supplement|placebo|placebo
16229288|NCT01168141|Drug|ZD4054|10mg ZD4054 daily in tablet form
16229289|NCT01168128|Other|Tailored Change Strategy|e.g. Education, decision support tools
16229290|NCT01168063|Drug|Molecular detection of antibiotic resistance|Helico DR®, triple therapy (Proton Pomp Inhibitor (PPI), amoxicillin, clarithromycin, metronidazole)
16229291|NCT01168063|Drug|standard triple therapy (PPI, amoxicillin, clarithromycin, metronidazole)|"2 lines of treatments :
~1) PPI + Amoxicillin + Clarithromycin for 7 days
~1) PPI + Amoxicillin + Metronidazole for 14 days"
16229292|NCT01168050|Drug|Nilotinib|Nilotinib 400 mg twice per day
16229293|NCT01168037|Device|Endovascular aortic repair with branched/fenestrated stent-graft|Insertion via bilateral femoral access, stent-graft deployment under fluoroscopic guidance, complementary stenting of visceral arteries, control angiogram
16229294|NCT01168037|Procedure|Open Surgical Repair|aortic replacement with revascularization of visceral arteries
16229295|NCT01168024|Device|CINCOR™ System and contrast conservation unit (CCS-1)|Catheter based system to reduce and remove contrast media and contrast modulator to reduce contrast media
16229296|NCT01168024|Other|Standard of Care plus peri-procedural hydration|The control group will receive a peri and post-procedural hydration rate.
16229297|NCT01168011|Drug|rigosertib|Doses of rigosertib up to 700 mg twice a day or three times a day for 21 days of 21-day cycles. Treatment may continue until progression.
16229347|NCT01167725|Procedure|therapeutic conventional surgery|Patients undergo cytoreductive surgery
16229348|NCT01167712|Biological|Bevacizumab|Given IV
16229298|NCT01167985|Device|IABN|Patients with single canal teeth diagnosed with infected pulp and periapical lesion, and need root canal treatment, will be asked to participate in the study. The study group will have their canal sealed with endodontic sealer + the nanoparticles. The control group will have their canal sealed with the conventional sealer alone. The patients will be invited to 4 follow ups during which a clinical and radiological examinations will be performed.While preparing the post, a sample of the sealer will be taken to evaluation in the lab.
16229299|NCT01167985|Device|IABN|patients with molar teeth diagnosed with healthy pulp or irreversible pulpitis, and need root canal treatment, will be asked to participate in the study. After cleaning the teeth following a standard protocol, a sterile cotton wool will be placed in the pulp chamber. provisional restoration with and without nanoparticles will seal the teeth between apointments. After a month the cotton wool will be taken out and tansferred to the laboratory. The root canal treatment will continue following the standard protocol.
16229300|NCT01167985|Device|IABN|Patients with single canal teeth diagnosed with infected pulp and periapical lesion, and need root canal treatment, will be asked to participate in the study. The study group will have their canal sealed with endodontic sealer + the nanoparticles. The control group will have their canal sealed with the conventional sealer alone. The patients will be invited to 4 follow ups during which a clinical and radiological examinations will be performed.While preparing the post, a sample of the sealer will be taken to evaluation in the lab.
16229301|NCT01167959|Procedure|Roux en Y gastric bypass and lap. gastric banding|Standard RYGB and LAGB procedures
16229302|NCT01167959|Behavioral|Prodimed dietary intervention|3 months of using the prodimed diet
16229303|NCT01167946|Drug|methylprednisolone sodium succinate|Group A will receive pulse treatment for 3 consecutive days once every 2 weeks for 24 weeks. The daily dose of each pulse treatment will consist of methylprednisolone sodium succinate 15mg/kg of ideal body weight, given orally in 200 ml of fresh orange juice.
16229304|NCT01167946|Drug|methylprednisolone sodium succinate|Group B will receive 2 consecutive daily pulses every 3 weeks for 24 weeks. The daily dose of each pulse treatment will consist of methylprednisolone sodium succinate 15mg/kg of ideal body weight, given orally in 200 ml of fresh orange juice.
16229305|NCT01167946|Drug|methylprednisolone sodium succinate|Group C will receive 3 consecutive daily pulses every 3 weeks for 24 weeks. The daily dose of each pulse treatment will consist of methylprednisolone sodium succinate 15mg/kg of ideal body weight, given orally in 200 ml of fresh orange juice.
16229306|NCT01167933|Drug|Simvastatin|Simvastatin 80 mg tablets Dr. Reddy's Laboratories Ltd
16229307|NCT01167920|Other|Virtual Hypertension Clinic|In the VHC group, patients will be ask to regularly measure blood pressure with the Stabil-o-Graph so that these readings are transmitted to Virtual Hypertension Clinic. The data will be reviewed weekly and the patient will receive feedback and intervention if needed at every 2 week interval to achieve blood pressure goal. Once they reach goal, the feedback will be less intense and given at four week intervals until the end of the study.
16229308|NCT01167907|Device|0.2% ropivacaine|0.2% ropivacaine by elastomeric infusion pump at 5ml/h started within 6h of catheter placement
16229309|NCT01167907|Drug|saline|saline (control) by elastomeric infusion pump at 5ml/h started within 6h of catheter placement
16229310|NCT01167894|Drug|Simvastatin|Simvastatin 80 mg tablets Dr. Reddy's Laboratories Ltd
16229311|NCT01167881|Drug|BI 10773|Medium dose once daily
16229312|NCT01167881|Drug|Glimepiride|1-4 mg once daily
16229313|NCT01167881|Drug|Placebo|Placebo matching BI 10773
16229314|NCT01167881|Drug|Placebo|Placebo matching Glimepiride
16229315|NCT01167868|Drug|FosD|oral tablet
16229316|NCT01167868|Drug|Placebo|oral tablet
16229317|NCT01167855|Other|Asthma Education Sessions|Comprehensive asthma education sessions delivered via telemedicine.
16229318|NCT01167855|Other|Asthma Health Assessment via Telemonitoring|Each intervention participant will undergo assessment of asthma via school-based telemonitoring to measure lung function and provide a self-report of asthma symptoms.
16229319|NCT01167855|Other|Provider Treatment Prompt|A treatment prompt will be mailed to the primary care provider at baseline and 3 months.
16229320|NCT01167855|Other|School Absenteeism|Absenteeism before and after the intervention will be compared in the intervention group and also will be compared to absentee rates of the usual care group.
16229321|NCT01167855|Other|Prescription Filling Profile|Study personnel will monitor participants' prescription profiles.
16229322|NCT01167829|Drug|Oral Testosterone|Oral Testosterone: 300 mg, pills, three times daily Day 1 - 10 (total of 27 pills)
16229323|NCT01167829|Drug|Acyline|300 ug/kg injection on Day 0
16229324|NCT01167816|Drug|Vidaza|Vidaza will be administered subq daily for 5 consecutive days each 28-day cycle
16229325|NCT01167803|Drug|Desflurane|Patients undergo anesthesia using remifentanil associated with desflurane
16229326|NCT01167803|Drug|Xenon|Patients undergo anesthesia using remifentanil associated with xenon
16229327|NCT01167790|Procedure|buccal cavity examination|autofluorescence examination
16229328|NCT01167764|Drug|tranexamic acid, placebo|tranexamic acid 250mg tid for 1 months vs. placebo for 1 months
16229329|NCT01167751|Biological|MNC|Implantation of BM derived MNC
16229330|NCT01167751|Biological|AC 133|Implantation of BM derived AC133
16229331|NCT01167751|Biological|Control|Injection of cell carrier
16229332|NCT01167738|Drug|capecitabine|1250 mg/mq days 1-28 every 4 weeks
16229333|NCT01167738|Drug|cisplatin|30 mg/mq on days 1 and 15 every 4 weeks
16229334|NCT01167738|Drug|epirubicin|30 mg/mq on days 1 and 15 every 4 weeks
16229335|NCT01167738|Drug|gemcitabine|800 mg/mq on days 1 and 15 every 4 weeks
16229336|NCT01167738|Drug|metformin|2 g days 1-28 every 4 weeks
16229337|NCT01167725|Biological|bevacizumab|Given IV
16229338|NCT01167725|Biological|cetuximab|Given IV
16229339|NCT01167725|Drug|FOLFIRI regimen|Given IV
16229340|NCT01167725|Drug|FOLFOX regimen|Given IV
16229341|NCT01167725|Drug|capecitabine|Given IV
16229342|NCT01167725|Drug|fluorouracil|Given IV
16229343|NCT01167725|Drug|irinotecan hydrochloride|Given IV
16229344|NCT01167725|Drug|leucovorin calcium|Given IV
16229345|NCT01167725|Drug|mitomycin C|Given intraperitoneally
16229346|NCT01167725|Drug|oxaliplatin|Given IV
16229352|NCT01167712|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16229353|NCT01167699|Drug|Oxycodone and naloxone|Oxycodone hydrochloride and naloxone hydrochloride combination, prolonged release
16229354|NCT01167686|Dietary Supplement|Gardemont Goldtrain Plus (GT+)|Four tablets of 760 mg of GT+ administered three times a day for seven consecutive days and similar placebo tablets given to the control arm
16229355|NCT01167673|Dietary Supplement|coltect|green tea 250 mg, selenium 100 micro gram, curcumin 500 mg
16229356|NCT01167673|Dietary Supplement|Placebo|placebo
16229357|NCT01167660|Device|The Thrombo-Monitor (ThM)|Non-invasive measurement of coagulation status and comparison to standard blood coagulation tests. In healthy neonates - immediately after birth, before the administration of vitamin K. Coagulation tests will be done on an umbilical cord blood sample. In sick neonates, coagulation studies will be done according to the medical condition.
16229358|NCT01167634|Behavioral|Deposit contract with a 1:1 match|Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made.
16229359|NCT01167634|Behavioral|Deposit contract with a 2:1 match|Daily weigh-in for 24 weeks and if each daily goal met daily deposit amount is paid back with an additional matched amount twice the amount equal to deposited amount. Final weigh-in at 36 weeks with no financial incentive or deposit made.
16229360|NCT01167634|Behavioral|Deposit Contract with no match|Daily weigh-in for 24 weeks and if each daily goal met the daily deposit amount is paid back. Final weigh-in at 36 weeks with no financial incentive or deposit made.
16229361|NCT01167608|Other|No Intervention. This is a cross-sectional survey study.|No intervention.
16229362|NCT01167595|Other|PEP uP Protocol|Protocol documents (i.e. pre-printed order, algorithm for advancing feed, and algorithm for calculating rate of administering feed as per 24hour volume) and a slide presentation coupled with educational reminders (posters and bedside notices) and practice helps (tool to remind nurse to measure and report nutritional adequacy) will be made available to all nurses, in bedside manuals and/or on the local intranet.
16229363|NCT01167582|Biological|Red blood cell transfusion|Liberal versus restrictive transfusion
16229364|NCT01167569|Drug|Ascorbic Acid|Ascorbic Acid/Placebo 10mg/kg body weight X2 in Operating Room followed by Ascorbic Acid/Placebo 5mg/kg x 48 hours.
16229365|NCT01167569|Other|5 % Dextrose Water or Normal Saline|100 ml D5W or NS X 2 in operating room and then every 4 hours for 48 hours.
16229366|NCT01167556|Behavioral|Family Motivational Intervention|A intervention with provided parents 6 sessions of Interaction Skills training and 6 sessions Motivational Interviewing training.
16229367|NCT01167530|Drug|Everolimus|First phase of the study:RAD001 (everolimus) will be administered per os every Monday, one week before then during the radiotherapy and will be continued for 3.5 weeks after the end of the radiotherapy. Chemotherapy is given 4.5 weeks after the end of radiotherapy. Three patient cohorts are planned, receiving 10, 20 and 50 mg of RAD001 per week.Second phase of the study:RAD001 (everolimus) will be administered per os every day one week before then during the radiotherapy and will be continued for 3.5 weeks after the end of radiotherapy. Chemotherapy is given 4.5 weeks after the end of radiotherapy. Three patient cohorts are planned, receiving 2.5, 5 and 10 mg of RAD001 per day.The two phases of the study may be conducted independently and in parallel.
16229368|NCT01167517|Other|Instructional digital video disc (DVD)|Breast milk expression instructions provided by digital video disc at the time of hospital discharge
16229369|NCT01167504|Other|Saliva sample collection|Collection of either whole mouth saliva or parotid saliva. Whole mouth saliva is collected through stimulation by inert gum. Parotid saliva is collected by using a Lashley cup placed over the parotid duct and stimulated by a fruit sweet.
16229370|NCT01167491|Biological|Physiopathology Endpoint Classification|Blood samples will be collected during a routine medical visit.
16229371|NCT01167478|Dietary Supplement|Caffeine|After ingestion of 6 mg.kg-1 of body mass of caffeine, subjects will perform the one exercise trial.
16229372|NCT01167478|Dietary Supplement|Caffeine|6 mg/kg of body mass of caffeine will be ingested by subjects before exercise.
16229373|NCT01167465|Other|Moussik Diaper Rash Mousse|To be used as instructed
16229374|NCT01167465|Other|Desitin Creamy Ointment|To be used as instructed
16229375|NCT01167452|Drug|Sulfamethoxazole/trimethoprim|2 DS tablets of trimethoprim/sulfamethoxazole x 1 dose
16229376|NCT01167439|Procedure|Upper esophageal sphincter myotomy|Upper esophageal sphincter release operation to allow better swallowing. The intervention is done under GA and by extra-mucosal approach.
16229377|NCT01167426|Drug|Glatiramer Acetate 20 mg/0.5 mL|20 mg/1.0 mL formulation of glatiramer acetate utilizing the autoject 2 for glass syringe.
16229378|NCT01167426|Drug|Glatiramer acetate 20 mg/0.5 mL|20 mg/0.5 mL formulation of glatiramer acetate utilizing the autoject 2 20 mg/0.5 mL device.
16229379|NCT01167413|Device|Evaluation by manual Dolorimeter|Patients will be examined by a manual Dolorimeter
16229380|NCT01167413|Other|SIJ imaging|Patients will undergo imaging of the Sacroiliac joint by plain x-ray or MRI and sacroileitis will be documented
16229381|NCT01167400|Behavioral|Cybercycling|exercising on a videogame-enhanced interactive 3D stationary bicycle for 3 months, 3-5x/wk
16229382|NCT01167400|Behavioral|Traditional exercise|exercising on a traditional stationary bike for 3 months, 3-5x/wk
16229383|NCT01167387|Dietary Supplement|PREOP|a carbohydrate beverage (total carbohydrates equal to 12.6g/100 mL: 2.1 g monosaccharide, 10.0 g maltodextrine; 240 mOsm/L) in dose of 800 mL
16229384|NCT01167387|Other|water|The control group will receive plain water with the same volume and timing of treatment.
16229385|NCT01167374|Radiation|Carbon Ion Radiotherapy|Increasing Dose of Carbon Ion Radiotherapy 4 x 10 Gy E to 4 x 14 Gy E
16229386|NCT01167348|Procedure|auricular acupressure|Investigator will put a tape with a 0.5mmx0.5mm seed on the specific positions on the ear of participants of intervention group, and participants will be asked to press these specific positions 3 times a day.
16229387|NCT01167335|Drug|BGG492|
16229388|NCT01167335|Drug|Placebo|
16229389|NCT01167322|Drug|NPC-07 for oral administration|NPC-07, containing 1.5g of 5-aminolevulinic acid hydrochloride per vial, is dissolved in 50 mL of water and will be administered orally 3 hours (range 2-4 hours) prior to induction of anesthesia at a dose of 20mg/kg body weight.
16229390|NCT01167309|Drug|LEO 27847|First in patient
16229391|NCT01167296|Device|Cook balloon uterine stent|Immediately before hysteroscopic surgery, a culture tip is inserted into the uterine cavity and sent for culture. Another culture was done 30 days later, and a second-look hysteroscope is done to evaluate the healing of uterine cavity.
16229392|NCT01167283|Device|Electrostimulation|Electrostimulation: 35 Hz, 0.4 ms, 1 h; 5 times/week
16229393|NCT01167283|Device|Sham stimulation|Sham stimulation: 1 h; 5 times/week
16229394|NCT01167270|Behavioral|Child Safety Insights|A child safety intervention with messages focused on the infant's environment and interactions with parents. They will be guided by the American Academy of Pediatrics as well as the Academy's guide for health supervision, Bright Futures.
16229395|NCT01167270|Behavioral|Parenting Insights|Educational program contains messages to provide developmentally appropriate guidance to parents of infants on responsive parenting and healthy lifestyle that will prevent rapid weight gain in infancy and overweight at age 3 years.
16229396|NCT01167257|Drug|Liposome encapsulated botulinum toxin A|Liposome encapsulated BoNT-A ( mixed BOTOX 200 U/10 mL water in Liposome 80 mg/40 mL water) in single intravesical instillation, one time treatment at the treatment day
16229397|NCT01167257|Drug|Normal saline instillation|Normal saline (BoNT-A/NS) 50 mL in single intravesical instillation
16229398|NCT01167244|Drug|BMS-690514|Tablets, Oral, 200 mg, once daily, until disease progression or toxicity
16229399|NCT01167231|Drug|Acarbose (Glucobay, BAYG5421)|Patients treated with acarbose tablets under the real-life setting. Dosing regimen customised to the needs of each participating patient according to the investigators assessment
16229400|NCT01167205|Dietary Supplement|astaxanthin|astaxanthin 20mg for 12 weeks
16229401|NCT01167192|Drug|Cisplatin|
16229402|NCT01167192|Drug|Carboplatin|
16229403|NCT01167192|Radiation|Radiation therapy|
16229404|NCT01167192|Procedure|Mastectomy (recommended but not mandatory)|
16229405|NCT01167179|Behavioral|nurse-led consultation|Content of the intervention The intervention consists of structured and standardised nursing follow up consultations comprising a thorough needs assessment, supportive counseling, adequate referral to other care providers if necessary and improvement of the continuity of follow-up care. The goals of nursing follow-up care are summarised as helping patients (and often their partners too) to cope with the physical and psychosocial consequences of treatment and help them to gradually adjust to 'the life after', and into survivorship.
16229406|NCT01167166|Drug|rigosertib|The dose of rigosertib will be 2400 mg/24h as an intravenous continuous infusion over 72 or 120 hours every 2 weeks for 2 cycles then as oral capsules administered at a dose of 560 mg twice daily on a continuous basis.
16229407|NCT01167153|Drug|Valsartan/Amlodipine|Valsartan/Amlodipine 80/5mg single pill combination (SPC)
16229408|NCT01167153|Drug|Nifedipine|Nifedipine GITS (Gastro-Intestinal Therapeutic System ) 30 mg
16229409|NCT01167140|Device|Cryo-Touch II|Percutaneous treatment with the device
16229410|NCT01167127|Drug|Oxycodone hydrochloride and naloxone hydrochloride combination, prolonged release|OXN Tablet, oral, BID, flexible dose design
16229411|NCT01167114|Drug|STA-9090|Given intravenously on Day 1, 8 and 15 of each 4 week cycle.
16229412|NCT01167101|Drug|Rebamipide|Rebamipide 100mg Tid for 28days
16229413|NCT01167101|Drug|pantoprazole|pantoprazole 40mg qd for 28days
16229414|NCT01167088|Drug|Mitoquinone mesylate|2 tablets to be taken daily upon wakening, with a glass of water and at least one hour before food.
16229415|NCT01167088|Drug|Placebo|Placebo
16229416|NCT01167075|Dietary Supplement|Fresubin Original|
16229417|NCT01167075|Dietary Supplement|Intestamin plus Fresubin Original|
16229418|NCT01167062|Drug|Tamsulosin Hydrochloride OCAS 0.4 mg|One tablet OD for a maximum of 28 days
16229419|NCT01167062|Other|Placebo|One tablet OD for a maximum of 28 days
16229420|NCT01167049|Drug|CAPECITABINE|Capecitabine(Xeloda) 1000 mg/m2 bid, d1-14; q3w; Paclitaxel 80mg/m2 d1,d8; q3w; Repeat three cycles (approximately 3- months);
16229421|NCT01167036|Device|FascialEdge instrument|Stroking massage to patient tolerance over the muscle
16229422|NCT01167036|Other|Placebo electric point stimulation|Detuned electric point stimulation over the involved muscle
16229423|NCT01167023|Drug|Prasugrel|Administered orally, once daily for 30 days.
16229424|NCT01167023|Drug|Placebo|Administered orally, once daily for 30 days.
16229425|NCT01167010|Drug|Formoterol/Budesonide|formoterol and budesonide will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
16229426|NCT01167010|Drug|Foraseq|foraseq will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
16229427|NCT01167010|Drug|Alenia|Alenia will be administered at the 12/400 µg dosage, twice a da for 12 weeks.
16229428|NCT01166997|Device|EkoSonic Endovascular System|The EkoSonic Endovascular System will be used to deliver < 20 mg of rt-PA ( Actilyse) directly into the occlusive pulmonary thrombus.
16229429|NCT01166997|Drug|Unfractionated heparin|Intravenous unfractionated heparin used for anticoagulation treatment
16229430|NCT01166984|Drug|AB103|Single intravenous infusion at doses of 7.5 µg/kg, 37.5 µg/kg, 150 µg/kg, or 450 µg/kg administered over approximately 10 minutes
16229431|NCT01166984|Drug|Placebo|Single intravenous infusion of normal saline (0.9% sodium chloride) administered over approximately 10 minutes
16229432|NCT01166971|Device|ReSTOR +3|Bilateral implantation of ReSTOR +3 Intraocular Lenses (IOLs) after cataract extraction
16229433|NCT01166971|Device|Tecnis MF|Bilateral implantation of Tecnis Multifocal (MF) Intraocular Lenses (IOLs) after cataract extraction
16229434|NCT01166958|Drug|Teriparatide|Teriparatide (TPD; Forteo) is supplied as a pre-filled syringe that dispenses 20 ug. The dose is one subcutaneous injection daily. Each pre-filled injection delivery device contains sufficient TPD for a 28-day supply of 20 mcg/day.
16229435|NCT01166958|Drug|Raloxifene|Raloxifene (RLX; Evista) is supplied as a 60 mg tablet. RLX is stored at room temperature.
16229436|NCT01166945|Drug|Amoxicillin-Potassium Clavulanate Combination|All subjects will be started on treatment with 5 days of high dose amoxicillin (90mg/kg) with potassium clavulanate (6.4 mg/kg) twice daily in bottle A. The allocation to group B1 or B2 will be concealed until after the family and subject has signed the assent and consent, respectively. The maximum dose will be 2 gms twice daily. After 5 days the subjects will be randomized to either continue to receive the same dose of amoxicillin clavulanate or a look-a-like and taste-a-like placebo for the next 9 days.
16229437|NCT01166945|Drug|Placebo|After 5 days the subjects will be randomized to either continue to receive the same dose of amoxicillin clavulanate or a look-a-like and taste-a-like placebo for the next 9 days.
16229438|NCT01166932|Drug|Amoxycillin/clavulanic acid|100mg/Kg/day/10 days.
16229439|NCT01166932|Drug|ceftriaxone/oxacillin|75 mg/Kg/day/10 days.
16229440|NCT01166919|Device|Matrix Radiofrequency|Matrix Radiofrequency Treatment of Port Wine Stain Birthmarks
16229441|NCT01166906|Device|pain blocking|pain blocking
16229442|NCT01166893|Device|Modulated Imaging and Laser Speckle Imaging|wound healing
16229443|NCT01166880|Device|Laser Speckle Imaging|Laser Speckle Imaging Infant Head Blood flow
16229444|NCT01166867|Device|Photo-plethysmography monitoring|monitoring vital sign in infant
16229445|NCT01166854|Device|Diffuse Optical Spectroscopy|Diffuse Optical Spectroscopy
16229446|NCT01166841|Procedure|PSVC line clamped|A line clamp will be placed on the PSVC line while on cardiopulmonary bypass.
16229447|NCT01166828|Behavioral|TELLEPUPPS|The TELEPUPPS participants will learn self care management of PUP through a program based on a social cognitive behavioral model to reinforce problem solving and self-efficacy in preventing pressure ulcers.
16229448|NCT01166815|Dietary Supplement|Zinc sulphate|Volunteers will be randomly assigned to either receive zinc sulphate supplements (20 mg/capsule) or a placebo containing no zinc. Maltodextrin serves as the carrier. The manufacturer is Tishcon Corporation, Westbury, NY.
16229449|NCT01166815|Other|Placebo|Volunteers will be randomly assigned to either receive zinc sulphate supplements (20 mg/capsule) or a placebo containing no zinc. Maltodextrin serves as the carrier. The manufacturer is Tishcon Corporation, Westbury, NY.
16229450|NCT01166789|Drug|Lubiprostone|48ug daily taken as 24ug capsules twice per day, in morning and evening.
16229451|NCT01166789|Drug|Placebo|2 capsules daily, taken in morning and evening
16229452|NCT01166763|Drug|vitamin D3|oral capsules, 10,000 IU per week for 6 months
16229453|NCT01166750|Behavioral|CD-ROM|"Treatment Group will continue to follow their treating rheumatologist's recommendations and prescriptions. The program will contain information on the multiple components of pain (the pain puzzle) as a treatment rationale and will then teach children to use cognitive-behavioral techniques for pain management. The information will be presented via visual displays, narration, and interactive menus. Children will be able to navigate through the different lessons at their own pace and will be required to take simple quizzes to assess their learning. Various passwords and homework assignments are embedded within the program to ensure that children are going through the material."
16229454|NCT01166750|Behavioral|Wait-list Control Group|Children in the control group will continue to follow recommendations and prescriptions by their treating rheumatologist. After an 8-week wait-list control condition that involves measurement phases identical to those of the Jointstrong Treatment Group but no Jointstrong treatment, the children in the control group will enter the Jointstrong program and will then have the same immediate post-treatment measures that the Treatment Group received. The Control Group will not, however, have the Treatment Group's 12-week follow-up phase.
16229455|NCT01166737|Procedure|Tumor Debulking Surgery (surgery in recurrent ovarian disease)|Surgery for Patients with platinum-sensitive recurrent ovarian cancer with a positive AGO-score predictive for complete tumor resection
16229456|NCT01166724|Drug|Sirolimus|Tacrolimus to Sirolimus
16229457|NCT01166724|Drug|Tacrolimus|dosage per trough level
16229458|NCT01166711|Device|Coroflex Blue (BMS) followed by SeQuent Please (DEB)|"standard techniques will be used
~maximal vasodilatation after nitro application
~baseline angiography with at least two orthogonal views (showing target lesion free of foreshortening or vessel overlap)
~6 French guiding catheter at least
~target lesion will be crossed with standard guidewire
~direct stenting at the discretion of the investigator
~if pre-dilation, a commercially available balloon will be used (length not exceeding the stent to be implanted)
~full lesion coverage will be ensured (with one or more stents)
~only insert assigned stent type
~BMS needs to be fully embedded in vessel wall
~post-dilation with high pressure is required before treatment with DEB
~DEB will be inflated with nominal pressure (balloon equates to vessel diameter)
~length of DEB should exceed the BMS by 2-3 mm on each side
~if dissection, full length of dissection and optional additional stented area should be treated with additional DEB (to avoid geographic miss)"
16229459|NCT01166711|Device|Coroflex Please (DES)|"standard techniques will be used
~maximal vasodilatation after nitro application
~baseline angiography with at least two orthogonal views (showing target lesion free of foreshortening or vessel overlap)
~6 French guiding catheter at least
~target lesion will be crossed with standard guidewire
~direct stenting at the discretion of the investigator
~if pre-dilation, a commercially available balloon will be used (length not exceeding the stent to be implanted)
~full lesion coverage will be ensured (with one or more stents)
~only insert assigned stent type"
16229460|NCT01166698|Drug|AZD9819|Inhaled single doses of suspension via SPIRA nebuliser
16229461|NCT01166698|Drug|AZD9819|Inhaled multiple doses of suspension via SPIRA nebuliser, once daily for 10 (maximum 14) days
16229462|NCT01166698|Drug|Placebo|Inhaled doses of suspension via SPIRA nebuliser given either as single (Part A) or multiple doses (Part B)
16229463|NCT01166685|Device|Everolimus-eluting stent|Everolimus-eluting stent
16229464|NCT01166685|Device|Bare-metal stent|Bare metal stent
16229465|NCT01166685|Device|Biodegradable Polymer-DES|drug-eluting stent with bioabsorbable polymer
16229466|NCT01166659|Device|CyPass Micro-Stent|The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front to the back of the eye. The CyPass is implanted in the eye.
16229467|NCT01166646|Drug|Halobetasol Proprionate Lotion 0.05%|Apply 3.5 grams twice daily for 1-2 weeks
16229468|NCT01166646|Drug|Halobetasol Proprionate Cream 0.05%|Apply 3.5 grams twice daily for 1-2 weeks
16229469|NCT01166633|Drug|pitavastatin|pitavastatin 2mg per daily
16229470|NCT01166633|Drug|atorvastatin|atorvastatin 10mg per daily
16229471|NCT01166594|Drug|Bevacizumab|Intrableb injection
16229472|NCT01166594|Drug|Control|intrableb BSS injection
16229473|NCT01166568|Device|PresVIEW Scleral Implants|Subjects are implanted with the PresView Scleral Spacing Implants and followed for 24 months.
16229474|NCT01166555|Drug|PF-04236921|single subcutaneous dose
16229475|NCT01166542|Biological|REOLYSIN|3E10 TCID50, 1 hour intravenous infusion, administered on Days 1, 2, 3, 4 and 5 of a 21 day cycle
16229476|NCT01166542|Drug|Carboplatin|5 AUC mg/mL min, 30 min intravenous infusion, given on Day 1 of a 21 day cycle
16229477|NCT01166542|Drug|Paclitaxel|175 mg/m2, 3 hour intravenous infusion, given on Day 1 of a 21 day cycle
16229478|NCT01166542|Drug|Placebo|Placebo
16229479|NCT01166529|Procedure|EUS-guided Celiac Plexus Neurolysis|All patients will receive anesthesia. The linear echo-endoscope will be advanced into the proximal stomach. It will be noted whether the tumor is seen in the celiac axis, if there is flow in the celiac artery, and if the celiac ganglia are seen. The celiac ganglia will be injected directly with 10cc of 0.25% bupivicaine followed by 10cc of 98% dehydrated alcohol. If the celiac ganglia cannot be identified, the posterior and anterior aspects of celiac artery take-off will be injected in a similar manner (twice the volume). Flow in the celiac axis will be confirmed. All injections will be performed with a standard EUS injection needle made especially for CPN . Prior to injection, aspiration will be performed through the needle to ensure that no blood is aspirated.
16229480|NCT01166516|Device|Treatment with HUD IBV Valve System|Treatment involves placing one or more valves in the airways of the lung to control a prolonged air leak.
16229481|NCT01166503|Procedure|mVEP Testing|Five small sensors are placed on the head which record the brain's response to moving stripes that are displayed on a computer screen. Each eye is tested while the other eye is patched. Each recording trial lasts about 10 seconds, and several trials are done for each eye.
16229482|NCT01166503|Procedure|Stereoacuity Testing|Subjects will have their 3D perception measured using standard clinical stereo tests (Randot, Lang, Titmus).
16229483|NCT01166503|Procedure|Optokinetic nystagmus testing|Subjects will be asked to view a screen with vertical stripes moving in both leftward and rightward directions while their eye movements are recorded using a remote video-based eye tracker.
16229484|NCT01166503|Procedure|Motion detection testing|Subjects will view a computer screen that has two panels of dots on them. The subject will be required to pick which panel has a section of dots that are moving in a specific direction (ie. nasalward/temporalward).
16229485|NCT01166503|Procedure|Motion discrimination testing|Subjects will view a computer screen that has two panels of randomly moving dots on them. The subject will be required to pick which panel has a section of dots that are moving in a specific direction (ie. nasalward/temporalward).
16229486|NCT01166490|Drug|ASG-5ME|0.3-3.0 mg/kg IV on Days 1, 8, and 15 of 28-day cycles
16229487|NCT01166477|Drug|Lopinavir and ritonavir|The patients will take Kaletra (lopinavir200mg/ritonavir50mg)two tablets bid
16229488|NCT01166477|Drug|Triple therapy with ritonavir|The patients will continue to take their usual triple therapy, as established in the summary of product characteristics
16229489|NCT01166464|Behavioral|text messaging for smoking cessation|A 7-week program of daily text messages
16229490|NCT01166464|Behavioral|Generic text messages|non-smoking related text messages will be given on the same daily schedule as matches the active intervention to establish a control for contact time.
16229491|NCT01166451|Dietary Supplement|Low-iron formula|Infants randomly assigned at 6 months of age to receive low-iron formula (average 2.3 mg/L, range 1.6 - 2.4 mg/L) until 12 months of age. Low-iron formula distributed in powdered form. Project personnel visited infants' homes weekly to record measures of powdered formula used per day. Formula consumption was also verified by the number of cans given by the clinic nurse at each visit (regular pediatric visits and monthly clinic appointments until 12 months of age.)
16229492|NCT01166451|Dietary Supplement|High-iron formula|Infants randomly assigned at 6 months of age to receive high-iron formula (average 12.7 mg/L) until 12 months of age. High-iron formula distributed in powdered form. Project personnel visited infants' homes weekly to record measures of powdered formula used per day. Formula consumption was also verified by the number of cans given by the clinic nurse at each visit (regular pediatric visits and monthly clinic appointments until 12 months of age.)
16229493|NCT01166438|Drug|Botulinum toxin A (Botox A®)|A single intradetrusor injection of 100U botulinum toxin A in 10 mL plus 0.1 mL of indigo carmine administered during cytoscopy. Between 100 and 200ml of saline is instilled into the bladder prior to injection to allow adequate visualization of the entire bladder urothelium. The treating physician will inject a total of 10.1 mL of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization using disposable needles. Injections will be spread out to equally cover the posterior bladder wall and dome, but spare the bladder trigone and ureteral orifices.
16229494|NCT01166438|Drug|Solifenacin 5mg|Oral Solifenacin 5mg once a day for up to 6 months
16229495|NCT01166438|Drug|Solifenacin 10mg|Oral Solifenacin 10mg once a day for up to 4 months
16229496|NCT01166438|Drug|Trospium chloride|Oral Trospium chloride XR 60mg once a day for up to 2 months
16229497|NCT01166425|Drug|Lithium Carbonate|Participants weighing ≥ 30 kg who are randomized to receive active lithium will begin treatment at 300 mg TID at visit 1 (total dose 900 mg). Participants weighing < 30 kg who are randomized to receive active lithium will begin treatment at 300 mg BID the day after visit 1 (total dose 600 mg). Based on the participant's response and tolerability, the dose will be increased by 300mg three days after the baseline visit and at scheduled in-office visits to the maximum tolerated dose. One mid-week dose increase will be scheduled in addition to the weekly increases at the scheduled in-clinic visits. On day 3 (+/- 2 days), a dose increase of 300 mg may occur based on the results of a telephone call placed by the study investigator to the participant's parent/guardian. During the telephone call, the prescribing clinician will assess medication adherence, adverse events, and overall improvement since baseline.
16229498|NCT01166425|Drug|Placebo|Participants who are randomized to receive placebo during the Efficacy Phase will receive matching placebo capsules. Dosing will be titrated as described for active lithium.
16229499|NCT01166412|Drug|levonorgestrel patch with BMI 32 kg/m2 to <40 kg/m2|6.5mg patch daily for 11 weeks
16229500|NCT01166412|Drug|levonorgestrel patch with BMI <32 kg/m2|6.5mg patch daily for 11 weeks
16229501|NCT01166412|Drug|levonorgestrel patch with BMI 32 kg/m2 to <40 kg/m2|12.5mg patch daily for 11 weeks
16229502|NCT01166412|Drug|levonorgestrel patch with BMI <32 kg/m2|12.5mg patch daily for 11 weeks
16229503|NCT01166386|Behavioral|FANCI|comprehensive neurobehavioral sessions with therapist administrating treatment components
16229504|NCT01166386|Behavioral|FANCI|Watching DVDs chosen by participants on various topics.
16229505|NCT01166373|Behavioral|Enrollment video|Standardized video detailing the importance of long-term follow-up studies for pelvic organ prolapse prior to the informed consent process
16229506|NCT01166373|Procedure|SSLF|sacrospinous ligament fixation to suspend the vaginal apex
16229507|NCT01166373|Procedure|ULS|uterosacral ligament suspension to suspend the vaginal apex
16229508|NCT01166373|Behavioral|PMT|perioperative behavioral therapy / pelvic muscle training with formal individualized PMT program that begins two to four weeks prior to surgery and continues for three months after surgery
16229509|NCT01166373|Other|Usual Care|usual care both before and after prolapse surgery with respect to pelvic muscle training
16229510|NCT01166347|Device|HeartWare® VAS|The HeartWare® VAS is an implantable centrifugal pump that was designed to provide flows up to 10 L/min in a small device that is both lightweight and simple to use.
16229511|NCT01166347|Device|Control LVAD|Any FDA-approved LVAD for destination therapy.
16229512|NCT01166334|Behavioral|WebQuit study group|Description withheld to protect integrity of study
16229513|NCT01166334|Behavioral|WebQuit control group|Identity and description withheld to protect integrity of study
16229514|NCT01166321|Radiation|Carbon Ion Radiotherapy|Carbon Ion Boost 18 Gy E in single Fractions of 3 Gy E
16229515|NCT01166308|Radiation|Carbon Ion Radiotherapy|Carbon Ion Radiotherapy in the RD determined within the Phase I part of the Study (10 x 3Gy E to 16 x 3 Gy E)
16229516|NCT01166308|Radiation|Fractionated Stereotactic Radiotherapy (FSRT)|Standard Treatment as Re-Irradiation performed as Fractionated Stereotactic Radiotherapy (FSRT)up to 36 Gy in single doses of 2 Gy
16229517|NCT01166282|Biological|adalimumab|Adalimumab solution for subcutaneous injection.
16229518|NCT01166282|Biological|placebo for adalimumab|Placebo for adalimumab solution for subcutaneous injection.
16229519|NCT01166269|Biological|phleum pratense (grass-allergen)|6 injections of grass-allergen. Every dose will be 1000 SQ-U.
16229520|NCT01166269|Biological|phleum pratense (grass allergen)|3 injections of grass-allergen. Every dose will be 1000 SQ-U. Also 3 injections of placebo (physiological saline)
16229521|NCT01166269|Other|physiological saline|6 injections of placebo (physiological saline)in a lymph node.
16229522|NCT01166256|Device|Non-invasive ventilation|Noninvasive ventilation: The inspiratory(IPAP) and expiratory positive airways pressure (EPAP), and the levels of FiO2 is set achieve SpO2 >92% or PaO2 >65 mmHg.
16229523|NCT01166256|Device|High flow nasal cannula system|High flow nasal cannula system: FiO2 and flow rate of oxygen is set to achieve SpO2 >92% or PaO2 >65 mmHg.
16229524|NCT01166243|Biological|Fibrin Pad|Fibrin Pad is a sterile bio-absorbable combination product consisting of two constituent parts- a flexible matrix and a coating of two biological components (Human Fibrinogen and Human Thrombin).
16229525|NCT01166243|Procedure|Standard of Care|Standard of Care is a composite of techniques/methods typically used by the surgeon to control bleeding.
16229526|NCT01166217|Drug|PF-04620110|"The five treatments are:
~A) single dose of 5 mg immediate release tablets in the fasted state; B) single dose of 5 mg modified release osmotic capsule with a short duration of modified release 1 (MR1) in the fasted state; C) single dose of 5 mg modified release osmotic capsule with a long duration of modified release 2 (MR2) in the fasted state; D) single dose of 5 mg modified release osmotic capsule with a short duration of modified release 1 (MR1) in the fed state; E) single dose of 5 mg modified release osmotic capsule with a long duration of modified release 2 (MR2) in the fed state."
16229527|NCT01166204|Radiation|Radiotherapy|Radiotherapy
16229528|NCT01166191|Radiation|Radiotherapy|Radiotherapy
16229529|NCT01166178|Drug|Zoledronic Acid|Zoledronic acid 5 mg once a year via intravenous infusion
16229530|NCT01166178|Drug|Placebo|Placebo to zoledronic acid once a year via intravenous infusion
16229531|NCT01166178|Dietary Supplement|Calcium and Vitamin D combination|Calcium 500 mg and Vitamin D 400 IU combined tablet, taken orally twice a day
16229532|NCT01166165|Drug|Cholecalciferol|3 tablets of 1000 IU daily for 20 weeks
16229533|NCT01166165|Drug|Placebo|3 placebo tablets daily for 20 weeks
16229534|NCT01166152|Behavioral|social skills training|meeting once a week or biweekly to play together using toys, games, and physical exercises.
16229535|NCT01166139|Drug|Nilotinib (Tasigna)|Patients will be treated with Nilotinib 400 mg two times a day for 6 months.
16229536|NCT01166126|Drug|temsirolimus|Given IV
16229537|NCT01166126|Drug|selumetinib|Given orally
16229538|NCT01166126|Other|laboratory biomarker analysis|Correlative studies
16229539|NCT01166113|Drug|Pomalidomide, Cyclophosphamide, Prednisone|"Induction
~This multicenter phase I followed by a phase II trial will evaluate the safety and efficacy of the combination Pomalidomide-Cyclophosphamide-Prednisone (PCP) in patients (pts) with MM relapsed/refractory to lenalidomide.
~In the phase I we assess the maximum tolerated dose (MTD) of PCP in 25% of pts. The first 4 pts are given the second dose level, accrual continues with 4 pts per dose level for a maximum of 24 pts.
~The dose level associated with an updated DLT is recommended for the next patient cohort.
~Each patient is assigned to a salvage therapy including Cyclophosphamide and Prednisone (both 50 mg every other d), and Pomalidomide at one of the following doses:1 mg/d;1.5 mg/d;2 mg/d;2.5 mg/d
~In the phase II a total of 43 pts will be treated with the MTD of PCP. Pts enrolled at the MTD during the phase I will be included in the Phase II trial.
~Maintenance (each cycle repeated every 28 d, until PD) Pomalidomide: 2.5 mg/d; Prednisone: 25 mg every other d"
16229540|NCT01166100|Drug|Fluoxetine Hydrochloride|Fluoxetine Hydrocloride Delayed Release Capsules, 90 mg of Dr. Reddy's Laboratories.
16229541|NCT01166087|Drug|Fluoxetine Hydrochloride|Fluoxetine Hydrocloride Delayed-Release Capsules, 90 mg of Dr. Reddy's Laboratories.
16229542|NCT01166074|Biological|Subcutaneous IgG (SCIG)|Administered according to normal clinical practice
16229543|NCT01166061|Biological|Placebo|Solution resembling active solution but without peptides
16229544|NCT01166061|Biological|ToleroMune Grass|1 x4 administrations 4 weeks apart
16229545|NCT01166048|Drug|Duloxetine|"Patients will receive 120mg of Duloxetine for the duration of 2 weeks after a dosage titration of 2 weeks according to the following scheme: (p=placebo)
~day: 1 2 3 4 5 6 7: p-30mg p-30mg p-30mg p-30 mg p-30mg p-30mg p-60mg
~day: 8 9 10 11 12 13 14: p-60 mg p-60 mg p-60mg p-60mg p-60mg p-60mg 60-60mg"
16229546|NCT01166048|Drug|Duloxetine|2 weeks of titration of duloxetine to 120mg, (1-0-1), 2 weeks of continuation on 120mg/day.
16229586|NCT01165723|Biological|PF-04427429|Intravenous dosing of 30mg on day 1 and one other day to be determined up to day 30
16229587|NCT01165723|Biological|PF-04427429|Intravenous dosing of 30mg on day 1 and one other day to be determined up to day 30
16229547|NCT01166035|Drug|Lenalidomide|"Lenalidomide will be supplied as 5 mg, 10 mg, 15 mg, 20 mg and 25 mg capsules for oral administration.
~Prior to Cycle 1, there will be a 21 day lead in treatment period with lenalidomide monotherapy (Days -21 to -1). Combination treatment will start at Day 1. Subjects will be enrolled in cohorts of three to receive a single, oral dose of lenalidomide administered on Days 1-28. For each cohort of subjects, the decision of whether or not to dose-escalate will be made after subjects have received the first treatment cycle of study drug. Treatment will continue until the occurrence of any of the following events.
~Disease progression
~Adverse event(s) that, in the judgment of the Investigator, may cause severe or permanent harm or which rule out continuation of the treatment regimen.
~Major violation of the study protocol.
~Withdrawal of consent
~Lost to follow up
~Death
~Suspected pregnancy"
16229548|NCT01166035|Drug|Cetuximab|"Combination treatment will start at Day 1. Subjects meeting will be enrolled in cohorts of three to receive infusions of cetuximab (400 mg/m2 first infusion only, then 250 mg/m2 subsequently) administered on Days 1, 8, 15, and 22 of each 28-day cycle. Cetuximab will be supplied as Erbitux® 22 mg/ml Vial à 50 ml, Erbitux 5 mg/ml Vial à 10 ml and Erbitux 5 mg/ml Vial à 50 ml for intravenous administration.
~Treatment will continue until the occurrence of any of the following events.
~Disease progression
~Adverse event(s) that, in the judgment of the Investigator, may cause severe or permanent harm or which rule out continuation of the treatment regimen.
~Major violation of the study protocol.
~Withdrawal of consent
~Lost to follow up
~Death
~Suspected pregnancy"
16229549|NCT01166022|Other|Exercise|Muscle strengthening program using hand weights and resistance bands in combination with a home based cycle ergometry. This home-based exercise program will be performed up to 5 times weekly. Each session will consist of up to 30 minutes of cycling and 30 minutes of strengthening.
16229550|NCT01165996|Other|flow cytometry|Correlative studies
16229551|NCT01165996|Other|DNA methylation analysis|Correlative studies
16229552|NCT01165996|Other|cytogenetic analysis|Correlative studies
16229553|NCT01165996|Drug|decitabine|Given subcutaneously
16229554|NCT01165996|Genetic|microarray analysis|Correlative studies
16229555|NCT01165996|Genetic|gene expression analysis|Correlative studies
16229556|NCT01165996|Other|pharmacological study|Correlative studies
16229557|NCT01165996|Genetic|polymorphism analysis|Correlative studies
16229558|NCT01165983|Drug|Placebo|0mg tablet, taken orally for 12 weeks daily
16229559|NCT01165983|Drug|Aliskiren|150mg tablet, taken orally for 12 weeks daily
16229560|NCT01165970|Drug|Glandosane|according to the german law the sued saliva substitute is a drug (Glandosane) whereas Saliva natura is a medical product
16229561|NCT01165970|Device|Saliva natura|Saliva substitute without restriction to be used
16229562|NCT01165944|Drug|Pramlintide|Pramlintide administered pre-meal starting at 60 mcg and titrating up to 120 mcg within 4-6 weeks
16229563|NCT01165931|Drug|Riociguat (BAY63-2521)|0.1 mg intracoronary infusion through coronary guide catheter. Single dose. Sequential application after initial vasoactive bolus of Adenosine (non-study drug) and Nitroglycerin (non-study drug).
16229564|NCT01165905|Drug|ON 01910.Na|The starting dose of ON 01910.Na is 250 mg/m2 as a 24 hour intravenous (i.v.) infusion on days 1, 8 and 15 of a 28-day course. The dose of ON 01910.Na will be escalated in increments in successive cohorts (dose level (DL) 1 = 250 mg/m2, DL 2 = 650 mg/m2, DL 3 = 1050 mg/m2, DL 4= 1350 mg/m2) of new patients. A course is defined as 4 weeks in length.
16229565|NCT01165905|Drug|Gemcitabine|The dose of gemcitabine will be fixed at 1000 mg/m2 i.v. as a 30 minutes infusion on days 1, 8, and 15 every 28 days.
16229566|NCT01165892|Drug|Gadofosveset Triodium|Use of 0.03 mmol/Kg of gadofosveset trisodium (Ablavar)once with intravascular half life of up to 1 hr and optimal arterial imaging out to 20-30 minutes.
16229567|NCT01165866|Drug|Treatment 1. Metoclopramide|metoclopramide 0.3mg/kg maximum dose 10mg will be added in the burette and mixed with normal saline to make up 50cc of medication for intravenous administration.
16229568|NCT01165866|Drug|Treatment 2 Ondansetron|Single dose of Ondansetron 0.15 mg/kg
16229569|NCT01165853|Other|Glucose|25% dose at 8-week intervention assigned to subjects.
16229570|NCT01165853|Other|Fructose|25% dose at 8-week intervention assigned to subjects.
16229571|NCT01165840|Drug|Dapsone|100 mg PO x 1 dose
16229572|NCT01165814|Drug|Naproxen Tramadol|
16229573|NCT01165801|Procedure|Cataract Surgery|Fifty-four patients with cataract and non-exudative age-related macular degeneration (AMD) were randomized into an early surgery group (ES=28) with immediate cataract surgery and a control group (CO=26) where surgery was performed after six months.
16229574|NCT01165788|Procedure|Semi structured personal interview|A trained research assistant will conduct in-person, in-depth semi-structured interviews at a location of the participants choosing. Participants will be asked to discuss their experiences with cancer, focusing especially on how their cancer affected their (1) work/education (2) relationships with their family (spouse, children, parents, siblings and other relatives) (3) their other social relationships
16229575|NCT01165775|Device|Dexcom Seven Plus Continuous Glucose Monitoring System|Soft sensor for continuous glucose monitoring inserted for up to 24 hours prior to administration of betamethasone. Device to be worn for duration of hospitalization or up to 7 days total, whichever time period is shorter.
16229576|NCT01165762|Drug|Immune Tolerance|"Immune tolerance Kidney and hematopoietic cell transplantation with a conditioning regimen of total lymphoid irradiation and antithymocyte globulin followed by immunosuppressive drugs for 18 months. Immunosuppressive drugs are stopped if stable chimerism is achieved and there is no rejection of the transplant kidney.
~The IDE used in this study is the column used for hematopoietic cell sorting."
16229577|NCT01165749|Behavioral|stop exercising|
16229578|NCT01165736|Drug|PF-05186462|single intravenous infusion of 100 microgram
16229579|NCT01165736|Drug|PF-05186462|single oral administration of 100 microgram
16229580|NCT01165736|Drug|PF-05089771|single intravenous infusion of 100 microgram of PF-05089771
16229581|NCT01165736|Drug|PF-05089771|single oral administration of 100 microgram PF-05089771
16229582|NCT01165736|Drug|PF-05150122|single intravenous administration of 100 microgram PF-05150122
16229583|NCT01165736|Drug|PF-05150122|single oral administration of 100 microgram PF-05150122
16229584|NCT01165736|Drug|PF-05241328|single intravenous infusion of 100 microgram PF-05241328
16229585|NCT01165736|Drug|PF-05241328|single oral administration 100 microgram PF-05241328
16229588|NCT01165710|Other|Patients with Atrial Fibrillation (AF)|Treatment patterns of AF according to patient demographics, clinical factors, risk stratification, and geographic regions.
16229589|NCT01165697|Other|Fluorescein angiography|Fluorescein angiography once every 6 months for 3 years
16229590|NCT01165684|Drug|insulin aspart|"Insulin aspart added stepwise according to the largest meal following an evaluation of HbA1c.
~Doses individually adjusted."
16229591|NCT01165684|Drug|insulin aspart|Insulin aspart added before each main meal. Doses individually adjusted.
16229592|NCT01165684|Drug|insulin detemir|Insulin detemir as basal insulin, adminstered once daily. Doses individually adjusted.
16229593|NCT01165671|Radiation|Carbon Ion Radiotherapy|Carbon ion Radiotherapy up to 18 Gy E in 3 Gy E fractions to the macroscopic tumor
16229594|NCT01165671|Radiation|Proton Radiotherapy|Proton Radiotherapy up to 10 Gy E in 2 Gy E fractions to the macroscopic tumor
16229595|NCT01165658|Radiation|Proton Therapy|The regimen of 45 Gy in 15 fractions will be delivered as a baseline, and then the fraction size will be escalated in two different intervals of 0.5 Gy each, with the ultimate dose being 60 Gy in 4 Gy fractions.
16229596|NCT01165645|Drug|lopinavir|Given orally
16229597|NCT01165645|Drug|ritonavir|Given orally
16229598|NCT01165645|Genetic|polymerase chain reaction|Correlative studies
16229599|NCT01165645|Other|flow cytometry|Correlative studies
16229600|NCT01165645|Other|enzyme-linked immunosorbent assay|Correlative studies
16229601|NCT01165645|Other|laboratory biomarker analysis|Correlative studies
16229602|NCT01165632|Procedure|biopsy|Correlative studies
16229603|NCT01165632|Procedure|computed tomography|Undergo computed tomography
16229604|NCT01165632|Procedure|therapeutic conventional surgery|Undergo stereotactic craniotomy
16229605|NCT01165632|Radiation|radiation therapy treatment planning/simulation|Undergo radiation therapy treatment planning/simulation
16229606|NCT01165632|Radiation|radiation therapy|Undergo radiation therapy
16229607|NCT01165632|Procedure|magnetic resonance imaging|Undergo magnetic resonance imaging
16229608|NCT01165632|Procedure|positron emission tomography|Undergo positron emission tomography
16229609|NCT01165632|Drug|fluorine F 18 fluorodopa|Given IV
16229610|NCT01165606|Procedure|Chest physiotherapy|
16229611|NCT01165593|Other|There is no intervention that is a part of this study.|There is no intervention that is a part of this study. Imaging data is gathered as part of normal care.
16229612|NCT01165580|Drug|valganciclovir [Valcyte]|oral dose, Days 1 and 2
16229613|NCT01165567|Drug|sarpogrelate|sarpogrelate, 300mg/day,duration: 4 weeks
16229614|NCT01165554|Drug|[18F] Flutemetamol|Flutemetamol (18F) Injection, 111 to 370 MBq (3 to 10 mCi), single intravenous injection.
16229615|NCT01165541|Drug|Mirtazapine|mirtazapine (7.5-45mg)
16229616|NCT01165541|Drug|Quetiapine fumarate extended release (Quetiapine XR)|Quetiapine fumarate extended release 50-400mg/d
16229617|NCT01165528|Procedure|type of mechanical ventilation|patients are randomized to receive one of the two types of mechanical ventilation for ARDS
16229618|NCT01165502|Drug|CM3.1-AC100|MAD study with repeated subcutaneous (sc) doses
16229619|NCT01165502|Drug|Placebo|Placebo for compound CM3.1-AC100 s.c.
16229620|NCT01165476|Drug|Treprostinil diethanolamine|sustained release tablets. One 1mg tablet per period. Two total doses.
16229621|NCT01165463|Behavioral|SOPT basic training|10 hours of basic training
16229622|NCT01165463|Behavioral|Crossword Puzzles|Subjects train with puzzles 10 hrs in lab.
16229623|NCT01165463|Behavioral|SOPT booster training|4 hours of subsequent booster-training
16229624|NCT01165450|Drug|Nexagon|There will be 3 groups of patients with persistent epithelial defects, treated in a dose-escalation fashion from 1µg to 3µg to 10 µg. Each group will consist of 18 patients randomized to Nexagon and 6 patients randomized to placebo only.
16229625|NCT01165450|Drug|Vehicle only|There will be 3 groups of patients with persistent epithelial defects, treated in a dose-escalation fashion from 1µg to 3µg to 10 µg. Each group will consist of 18 patients randomized to Nexagon and 6 patients randomized to placebo only.
16229626|NCT01165437|Device|Blood Pressure Measurement|Systolic blood pressures will be obtained from each limb using Doppler, oscillometric, and photoplethysmographic (PPG) modalities.
16229627|NCT01165424|Drug|mometasone furoate|"MFNS 50 μg spray device
~3 to 11 years: one spray per nostril once daily (100 μg/day) in the morning.
~12 to 15 years: 2 sprays per nostril once daily (200 μg/day) in the morning."
16229628|NCT01165385|Drug|cisplatin|60, 75 or 100 mg/m2 , day 1 - 3 weekly
16229629|NCT01165385|Drug|Pazopanib|400 mg, 600 mg or 800 mg/day, daily
16229630|NCT01165372|Drug|Artesunate or dihydroartemisinin-piperaquine|artesunate 2mg/kg/day, artesunate 4mg/kg/day or dihydroartemisinin-piperaquine once daily
16229631|NCT01165359|Drug|ITX 5061|"For Part A of the study: 150 mg of ITX 5061, once a day for 3 days; 75 mg of ITX 5061, once a day for 3 days; or 25 mg of ITX 5061, once a day for 3 days.
~For Part B of the study: 150 mg of ITX 5061, once a day for 14 days; 75 mg of ITX 5061, once a day for 14 days; or 25 mg of ITX 5061, once a day for 14 days.
~For Part C of the study: 150 mg of ITX 5061, once a day for 28 days; 75 mg of ITX 5061, once a day for 28 days; or 25 mg of ITX 5061, once a day for 28 days."
16229632|NCT01165359|Drug|Placebo ITX 5061|"For Part A of the study: placebo, once a day for 3 days.
~For Part B of the study: placebo, once a day for 14 days.
~For Part C of the study: placebo, once a day for 28 days."
16229633|NCT01165346|Radiation|Fiducials|Implantation of fiducials
16229634|NCT01165346|Radiation|CyberKnife|3 fractions over 8 to 10 days, 15 Gy/fraction
16229635|NCT01165333|Drug|Cilengitide dose escalation|"Cilengitide will be administered intravenously over 60 minutes, twice a week, at a given dose.
~The Cilengitide dose (mg/m²/infusion)levels are as follows :
~240
~480
~720
~1200
~1800"
16229636|NCT01165333|Drug|Cilengitide|Patients will be treated at the recommended dose in order to confirm the recommended cilengitide dose and to carry out the exploratory investigations
16229637|NCT01165333|Radiation|Concomitant radiotherapy|1.8 Gy per fraction for a total of 54 Gy over 6 weeks, from monday to friday of the first cycle. The radiation will imperatively begin between 3 and 7hours after the end of Cilengitide infusion.
16229671|NCT01165125|Drug|ketoconazole|400mcg overencapsulated tablets
16229672|NCT01165125|Drug|ketoconazole (placebo to match)|placebo to match overencapsulated tablets
16229638|NCT01165333|Biological|Pharmacokinetic|A pharmacokinetic assessment for Cilengitide will be carried for all patients. The pharmacokinetic (PK) samples will be drawn during day 1 and day 2 of the first cycle of treatment.
16229639|NCT01165333|Biological|Pharmacogenetic|For every patient 1 blood sample will be taken before study treatment. These blood samples can be made at any hour of the day, and does not require to be taken on an empty stomach. DNA will be extracted in the Laboratory of Pharmacology.Constitutional polymorphisms of genes will be measured before the treatment initiation.
16229640|NCT01165333|Biological|Exploratory investigation|Evaluate the metabolic impact of the treatment with dynamic MRI (diffusion, perfusion, spectro), and with FDG-PETand sestamibi SPECT.
16229641|NCT01165320|Drug|Caspofungin|
16229642|NCT01165307|Drug|Estradiol 30mcg / Levonorgestrel 150mcg monophasic oral contraceptive pills|Each packet consists of a fixed dose of 30mcg estradiol and a 150mcg dose of levonorgestrel for the first 21 days of the cycle, followed by a 7 day pill free period. Subjects will be instructed to administer the pills orally, starting 5 days after the start of menstrual blood flow, continuing cyclically, thus allowing for withdrawal bleeding after the 21 day pill cycle.
16229643|NCT01165307|Drug|Naproxen sodium pills|As an alternative to oral contraceptive pills, subjects may take Naproxen 500 mg with onset of menses, then 250 mg three times daily for the duration of the menses (or maximum of five days)
16229644|NCT01165307|Device|NovaSure® Radiofrequency Endometrial Ablation|Radiofrequency endometrial ablation is performed in the outpatient surgery department. Subjects receive intravenous medication, determined by the attending anesthesiologist, sufficient to induce conscious sedation during the procedure.
16229645|NCT01165294|Drug|Placebo|An intravenous bolus will be given in 5 minutes time followed by a 1 minute break after which a continuous infusion will start. Dosage lowered every 10 minutes
16229646|NCT01165294|Drug|ketamine|An intravenous bolus of 0.1 mg/kg will be given in 5 minutes followed by a 1 minute break after which a continuous infusion will start at 0.015625 mg/kg/min.
16229647|NCT01165281|Drug|Oxycodone CR|One 5 mg to 40 mg capsule twice daily for 4 weeks.
16229648|NCT01165281|Drug|R331333 (referred to as JNS024 ER or CG5503)|One 25 mg to 200 mg capsule twice daily for 4 weeks.
16229649|NCT01165268|Drug|Dapagliflozin|Tablets, Oral, 10 mg, Once daily, 7 days
16229650|NCT01165255|Drug|3. Exposure to other antidepressants during the first trimester comparison cohort|"Exposure to other antidepressants during first trimester was classified in the original study using pharmacy claims submitted electronically to the Ingenix Research Database to indicate dispensing of other antidepressants. Infants were classified according to maternal exposure to other antidepressants during the first trimester. The first trimester was estimated as the earliest probable conception date through 91 days (13 weeks) following the latest probable conception date (based on delivery diagnosis codes). This study will refine the exposure classifications into infants born to women who were exposed only to one type of an antidepressant (other antidepressant monotherapy), or more than one type of an antidepressant (other antidepressant mono or polytherapy) during the first trimester. A woman was considered exposed if there is at least one dispensing of another antidepressant during the first trimester of pregnancy."
16229651|NCT01165255|Drug|2. Exposure to bupropion outside the first trimester comparison cohort|"Exposure to bupropion outside the first trimester was classified in the original study using pharmacy claims submitted electronically to the Ingenix Research Database to indicate a dispensing of bupropion. The comparison cohort (bupropion exposure outside the first trimester) included women whose bupropion exposure occurred at least one month before the estimated date of conception and women whose bupropion exposure occurred after the first trimester, but before delivery. This study will refine the exposure classifications into infants born to women, who were exposed only to bupropion (bupropion monotherapy), or bupropion and another type of an antidepressant (bupropion mono-or polytherapy) during the period outside the first trimester."
16229652|NCT01165255|Drug|1. Exposure to bupropion during the first trimester|"Exposure to bupropion during the first trimester was classified in the original study using pharmacy claims submitted electronically to the Ingenix Research Database to indicate a dispensing of bupropion. Infants were classified according to maternal exposure to bupropion during the first trimester. The first trimester was estimated as the earliest probable conception date through 91 days (13 weeks) following the latest probable conception date (based on delivery diagnosis codes). This study will refine the exposure classifications into infants born to women, who were exposed only to bupropion (bupropion monotherapy), or bupropion and another type of an antidepressant (bupropion mono-or polytherapy). A woman was considered exposed in the first trimester if there was at least one dispensing of bupropion during the first trimester of pregnancy."
16229653|NCT01165242|Biological|Meningococcal vaccine GSK 134612|One intramuscular injection
16229654|NCT01165242|Biological|Menactra®|One intramuscular injection
16229655|NCT01165229|Biological|Herpes Zoster Vaccine GSK1437173A|Intramuscular injection
16229656|NCT01165229|Biological|Placebo|Intramuscular injection.
16229657|NCT01165216|Drug|Ipilimumab, 3 mg|Intervenous (IV) injection, administered every 3 weeks for up to 6 cycles
16229658|NCT01165216|Drug|Ipilimumab, 10 mg|IV injection, administered every 3 weeks for up to 6 cycles
16229659|NCT01165216|Drug|Paclitaxel|IV injection, 175 mg/m^2, administered every 3 weeks for up to 6 cycles
16229660|NCT01165216|Drug|Carboplatin|IV injection, AUC=6, administered every 3 weeks for up to 6 cycles. (AUC=area under the concentration curve)
16229661|NCT01165203|Biological|Herpes Zoster Vaccine GSK1437173A|intramuscular injection
16229662|NCT01165203|Biological|Placebo|intramuscular injection
16229663|NCT01165177|Biological|Herpes Zoster Vaccine GSK1437173A|Intramuscular injection
16229664|NCT01165177|Biological|Placebo|Intramuscular injection
16229665|NCT01165164|Other|FID 115958D (lubricant eye drop)|1 drop in each eye at bedtime
16229666|NCT01165151|Behavioral|behavioral weight loss program|weekly, group-based lifestyle weight loss program
16229667|NCT01165138|Drug|Fluticasone furoate/Vilanterol Inhalation Powder|Fluticasone furoate/Vilanterol Inhalation Powder inhaled orally once daily for 12 weeks
16229668|NCT01165138|Drug|Fluticasone Furoate Inhalation Powder|Fluticasone Furoate Inhalation Powder inhaled orally once daily for 12 weeks
16229669|NCT01165138|Drug|Placebo Inhaltion Powder|Placebo Inhaltion Powder inhaled orally once daily for 12 weeks
16229670|NCT01165125|Drug|FF / GW642444|200mcg/25mcg Novel DPI
16229675|NCT01165112|Biological|Rituximab|Given IV
16229676|NCT01165112|Drug|Etoposide|Given IV
16229677|NCT01165112|Other|Laboratory Biomarker Analysis|Correlative studies
16229678|NCT01165099|Procedure|acupuncture|The description of the acupuncture, whether manual, electro or sham, is as described for each of the individual groups.
16229679|NCT01165086|Other|Incorporating vegetables into the diet to reduce energy density|The entree portion of breakfast, lunch, and dinner meals will be manipulated to be a standard energy density, a 15% reduction in energy density, or a 25% reduction in energy density.
16229680|NCT01165073|Dietary Supplement|Osmolite and B.C.A.A.|Feeding inserted into enteral tubes
16229681|NCT01165073|Dietary Supplement|Normal oral intake & supplementation if necessary|Enteral nutrition
16229682|NCT01165060|Drug|Bezafibrate|Week 0 to 12: 400 mg once daily 1 tablet. Week 13 to 24: 400 mg once daily 2 tablets.
16229683|NCT01165047|Drug|Nitric Oxide|Nitric oxide, 80 ppm in air or oxygen will be administered using the GeNO nitrosyl delivery system with a standard nasal cannula at a flow rate of 4 LPM.
16229684|NCT01165034|Other|Breathlessness Support Service|Patients randomised to the intervention group (IG) will be entered into the BSS in addition to standard best usual care. Expertise in the BSS will comprise of a palliative care consultant or specialist registrar (SpR), a respiratory medicine consultant or SpR with a specialist interest in breathlessness, a respiratory physiotherapist, an occupational therapist and a respiratory nurse specialist. Patients will see 12 health professionals per visit, and multidisciplinary team meetings will take place before and after each visit. Outpatient clinics will take place once per week. The timing of interventions and data collection has been designed to allow for short disease trajectories in patients with cancer and minimise patient burden, whilst allowing time for interventions to have the desired effect. Four weeks is considered to be the minimum length of pulmonary rehabilitation programmes that give a clinically significant benefit.
16229685|NCT01165021|Drug|Pemetrexed|500 milligram per square meter (mg/m²) administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles
16229686|NCT01165021|Drug|Cisplatin|75 mg/m² administered as an intravenous infusion on Day 1 of 21-day cycles, for 3 cycles
16229687|NCT01165021|Drug|Folic Acid|Administered orally.
16229688|NCT01165021|Drug|Vitamin B12|Administered Intramuscular injection.
16229689|NCT01165021|Drug|Dexamethasone|Administered orally.
16229690|NCT01165008|Drug|Anakinra|
16229691|NCT01164995|Drug|MK-1775 and carboplatin|Carboplatin will be administered in a dose resulting in AUC5 (i.v. 30 min) at day 1 of each cycle. Concomittantly with the start of the carboplatin infusion 225 mg of MK-1775 will be administered as an oral capsule, followed by 4 additional doses at 12 hour increments ( = 5 BID doses of MK-1775 in 2.5 days in total). One cycle will last 21 days.
16229692|NCT01164982|Device|Mepitel One|Each subject will be followed once a week for 3 weeks or until healing if that occurs earlier
16229693|NCT01164969|Drug|Antibiotics to which H. pylori can not develope resistance|Amoxicillin, metronidazole and tetracyclin as primary drugs to treat H. pylori infection in duration of 10 days.
16229694|NCT01164956|Drug|methylphenidate|
16229695|NCT01164956|Other|Placebo|
16229696|NCT01164943|Procedure|Stimulation with human FSH|Human FSH
16229697|NCT01164943|Procedure|Stimulation with recombinant FSH|Recombinant FSH
16229698|NCT01164930|Behavioral|Acceptance and Commitment Therapy|8-week ACT group
16229699|NCT01164917|Drug|AMG811|Twelve subjects will be randomized to receive AMG 811 in Period 1 and will receive AMG 811 Placebo in Period 2. The AMG 811 and AMG 811 Placebo will be administered by injection.
16229700|NCT01164917|Drug|AMG811 Placebo|8 subjects will be randomized to receive AMG 811 Placebo in Period 1 and will receive AMG 811 in Period 2. The AMG 811 Placebo and AMG 811 will be administered by injection
16229701|NCT01164904|Drug|Amg 181|Ten escalating dose levels of AMG 181 administered as single dose SC or IV, in healthy volunteers and SC subjects with mild-to-moderate ulcerative colitis.
16229702|NCT01164891|Drug|RO5185426|Continuous oral dosing b.i.d. , on Day 15 a C isotope labeled dose will be administered
16229703|NCT01164865|Device|OPTI-FREE RepleniSH multipurpose disinfecting solution|FDA-approved, multipurpose disinfecting solution used according to provided instructions for cleaning, rinsing, storing, and disinfecting study contact lenses on a daily basis, 2 weeks.
16229704|NCT01164865|Device|Clear Care contact lens care system|FDA-approved, hydrogen peroxide-based, lens care system used according to provided instructions for cleaning, disinfecting, daily protein removing, and storage of study contact lenses on a daily basis, 2 weeks.
16229705|NCT01164865|Device|Contact lenses|Contact lenses per subject's habitual brand and prescription worn every day for the duration of the study, 14 days, on a daily wear basis without scheduled replacement.
16229706|NCT01164852|Procedure|Delivery|Termination of pregnancy (delivery)after completed corticosteroids
16229707|NCT01164826|Drug|Nabumetone|Nabumetone 750 mg Tablets of Dr. Reddy's Laboratories Limited
16229708|NCT01164826|Drug|Relafen|Relafen® 750 mg Tablets of Glaxosmithkline Research Triangle Park, NC.
16229709|NCT01164813|Drug|Nabumetone|Nabumetone 750 mg Tablets of Dr. Reddy's Laboratories Limited
16229710|NCT01164813|Drug|Relafen|Relafen® 750 mg Tablets of Glaxosmithkline Research Triangle Park, NC.
16229711|NCT01164800|Drug|Trandolapril|Trandolapril 4 mg Tablets of Dr. Reddy's Laboratories Limited
16229712|NCT01164800|Drug|Mavik|Mavik® 4 mg Tablets of Abbott Laboratories, USA.
16229713|NCT01164787|Drug|Trandolapril|Trandolapril 4 mg Tablets of Dr. Reddy's Laboratories Limited
16229714|NCT01164787|Drug|Mavik|Mavik® 4 mg Tablets of Abbott Laboratories, USA.
16229715|NCT01164774|Drug|Ramipril|Ramipril 10 mg Capsules of Dr. Reddy's Laboratories Limited
16229716|NCT01164774|Drug|Altace|Altace@ 10 mg capsules of Kings Pharmaceuticals, USA
16229717|NCT01164761|Drug|Ramipril|Ramipril 10 mg Capsules of Dr. Reddy's Laboratories Limited
16229718|NCT01164761|Drug|Altace|Altace@ 10 mg capsules of Kings Pharmaceuticals, USA
16229719|NCT01164748|Radiation|Lymphoscintigraphy|in all women a lymphoscintigraphy was done to investigate drainage patterns of a previous operated breast and axilla
16229720|NCT01164735|Other|Laboratory Biomarker Analysis|Correlative studies
16229721|NCT01164722|Other|clinical observation|Patients undergo observation
16229722|NCT01164722|Device|infrared photocoagulation therapy|Anal infrared coagulator ablation
16229723|NCT01164709|Drug|bortezomib|Bortezomib i.v., day 8, 11, 15, 18; 1.3 mg/m2
16229724|NCT01164709|Drug|nelfinavir mesylate|p.o., days 1 to 21; dose level: (625), 1250, 1875, or 2500 mg, 2x/d
16229725|NCT01164696|Drug|[90]Y-ibritumomab tiuxetan (Zevalin, BAY86-5128)|Zevalin was administered according to the directives in the approved package leaflet.
16229726|NCT01164683|Behavioral|Peer-driven intervention|Trained peers with sleep apnea will be paired with the newly diagnosed patients over a 3-month period. During this time the trained peers will share experiences on coping strategies with CPAP device and equipment (promote self efficacy), share their positive experiences (motivational effects and outcome expectancies), share their knowledge of perceived vulnerabilities due to untreated sleep apnea (promote risk perception), share methods for improving efficacy of CPAP equipment and interface (patient education) and prepare their subjects for upcoming physician or respiratory therapist appointments (patient activation).
16229727|NCT01164683|Other|Usual Care|All participants will receive usual care following initiation of CPAP therapy. Visits with respiratory therapist and sleep physician wherein patients are educated about the basics of the care and operation of the device, mask and related equipment. Subsequently, their CPAP adherence is monitored and appropriate interventions such as mask change and re-education undertaken as needed.
16229728|NCT01164657|Device|"BirthRite"|Randomization takes place on admission to delivery unit, study group participants seated on the birthing seat when cervix is fully dilated.
16229729|NCT01164644|Drug|Arnica montana|Subjects will take twelve pills by mouth three times a day over four days.
16229730|NCT01164644|Drug|Placebo|Subjects will take twelve pills by mouth three times a day over four days.
16229731|NCT01164631|Device|Bioajusta X Orthodontic treatment|Oral Appliance that promotes semi-rapid maxillary expansion, while corrects tongue positioning and jaws relationship
16229732|NCT01164618|Procedure|Remote ischemic preconditioning (RIPC)|RIPC will be induced using a standard blood pressure cuff and hand anaeroid sphygmomanometer, on the right arm. The subject will be seated, the blood pressure cuff placed on the arm and inflated to a pressure of 200mmHg for 5 minutes (ischemia). The cuff will then be deflated for 5 minutes (reperfusion) completing one cycle of ischemia reperfusion. A total of 4 inflation and deflation cycles will be applied. This protocol of RIPC will be applied daily, for 10 consecutive days.
16229733|NCT01164618|Other|Exercise|Subjects will then undergo exercise daily, for 10 consecutive days. A chronic high-intensity interval exercise training protocol standardized to subjects' aerobic power (VO¬2max) will be used. Each exercise session will consist of a 5 min warm-up period followed by 4 sets of 2 min high intensity intervals interspersed with 3 min recovery periods.
16229734|NCT01164605|Drug|Raltegravir|60 tablets (30-day supply)
16229735|NCT01164592|Device|adaptive servoventilation (ASV)|Patients randomised to therapygroup should use the adaptive servoventilation (ASV) device each night at least 3 hours
16229736|NCT01164579|Drug|Tasocitinib plus Methotrexate|Tofacitinib (CP 690,550) 10 mg BID, tablets + methotrexate (MTX) 10 mg/wk to 20 mg/wk, titrated over 2 months
16229737|NCT01164579|Drug|Tofacitinib plus placebo methotrexate|Tofacitinib (CP-90,550) 10 mg BID, tablets. Placebo to match methotrexate (MTX) capsules titrated as in Treatment Arm 1.
16229738|NCT01164579|Drug|Placebo tofacitinib plus Methotrexate|Methotrexate (MTX) 10 mg/wk to 20 mg/wk, capsules, titrated over 2 months. Placebo in tablets to match tofacitinib
16229739|NCT01164566|Procedure|endoscopic procedure|
16229740|NCT01164566|Other|questionnaire administration|Ancillary studies
16229741|NCT01164553|Biological|Trivalent Inactivated Influenza Vaccine|Either a standard pediatric dose (0.25 ml) or a larger dose (0.5 ml) of Trivalent Inactivated Influenza Vaccine (TIV) (Fluzone®) administered intramuscularly (IM) in the thigh with a 25 gauge 1 inch needle. Naive cohort (enrolled over two influenza seasons (2010-11 and 2011-12)) will receive vaccine in two IM doses 28-42 days apart, Fully Primed cohort (enrolled in one influenza season (2010-11)) will receive vaccine in one IM dose.
16229742|NCT01164540|Drug|Rosuvastatin (AZD4522)|Oral dose (od) 20 mg
16229743|NCT01164540|Drug|Placebo|Oral dose (od)
16229744|NCT01164514|Biological|CPG 7909|CPG 7909 is a synthetic oligodeoxynucleotide used as an adjuvant and administered at 2 different dosages: 250 mcg and 500 mcg.
16229745|NCT01164514|Biological|J5-OMP Vaccine|J5-OMP vaccine 10 mcg to be administered with and without CpG 7909 adjuvant 250 or 500 mcg, intramuscularly on Days 0, 29 and 59.
16229746|NCT01164514|Drug|Placebo|Normal saline.
16229747|NCT01164501|Drug|BI 10773|BI 10773 tablets once daily
16229748|NCT01164501|Drug|Placebo|Placebo tablets identical to BI 10773 low dose
16229749|NCT01164501|Drug|Placebo|Placebo tablets identical to BI 10773 high dose
16229750|NCT01164501|Drug|BI 10773|BI 10773 tablets once daily
16229751|NCT01164501|Drug|Placebo|Placebo tablets identical to BI 10773 low dose
16229752|NCT01164501|Drug|Placebo|Placebo tablets identical to BI 10773 high dose
16229753|NCT01164488|Drug|danoprevir|Repeated daily doses
16229754|NCT01164488|Drug|ketoconazole|Repeated daily doses
16229755|NCT01164488|Drug|ritonavir|Repeated daily doses
16229756|NCT01164475|Drug|Granulocyte-colony stimulating factor (G-CSF)|
16229757|NCT01164475|Drug|Fixed Dose Plerixafor|
16229758|NCT01164475|Drug|Weight-Based Plerixafor|
16229759|NCT01164462|Biological|blood test: rapid finger-stick blood specimen test|
16229760|NCT01164462|Biological|blood test: conventional test|
16229761|NCT01164449|Device|Space TGC|Space TGC with incorporated eMPC algorithm to establish glycaemic control with a blood glucose target range of 80-150 mg/dL (4.4-8.3 mM)
16229762|NCT01164423|Device|Space TGC|Space TGC with incorporated eMPC algorithm to establish glycaemic control with a blood glucose target range of 80-150 mg/dL (4.4-8.3 mM)
16229763|NCT01164384|Drug|Baminercept|
16229764|NCT01164345|Drug|Plerixafor|Plerixafor (mozobil) 240 mcg/kg SC will be administered in the evening, 10 hours prior to initiation of apheresis.G-CSF will be administered in the morning at 10 mcg/kg SC for 4 days prior to apheresis.
16229765|NCT01164332|Other|NRL972|Two-hour intravenous infusion of 5 and 15 mg per hour
16229810|NCT01163994|Other|erythema migrans patients treated with doxycycline|orally, 100 mg, bid, 15 days
16229811|NCT01163981|Other|Use of ultrasound guidance in cannulation|Use of guidance with duplex ultrasound to complete cannulation of dialysis access
16229766|NCT01164319|Procedure|Circumferential PVI and subcutaneous cardiac monitor implantation|"The left atrium (LA) and PVs were explored through a transeptal approach. Real-time 3D LA maps were reconstructed by using a nonfluoroscopic navigation system (CARTO, Biosense-Webster Inc.). The ipsilateral left and right PVs were encircled in one lesion line by circumferential PV isolation. Radiofrequency energy was delivered at 43°C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and was reduced to 43°C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation speed of 17 mL/min. The endpoint of ablation was PV isolation; this was confirmed when Lasso mapping showed the disappearance of all PV potentials or the dissociation of PV potentials from LA activity.
~The ICM (Reveal XT, Medtronic Inc) was implanted the day of the ablation procedure or 1 week before.The Reveal XT was implanted in the parasternal area of the chest. The requirement for defining the exact final position was an R-wave amplitude ≥0.4 mV assessed through the Vector Check."
16229767|NCT01164306|Behavioral|LifeSkills Training|"LifeSkills Training (Botvin's) is an evidenced based substance abuse prevention program for elementary school students to learn skills to resist tobacco, alcohol, drug abuse, and violence.
~Parent LifeSkills will also be utilized. Parents are provided a parent manual and DVD to use at home with their child to reinforce what they are taught in school-based LifeSkills sessions."
16229768|NCT01164306|Behavioral|Healthy Lifestyle Behavior Choices|"The healthy lifestyle behavior choices curriculum augments the state health curriculum in the assigned study schools.
~Parents will also be given health related information by mail to parallel the information students receive in school health classes."
16229769|NCT01164306|Behavioral|NRT and Motivational Interviewing (MI)|For parent/guardian smokers who want to quit, NRT is offered in conjunction with MI.
16229770|NCT01164293|Device|Atopy patch test with food allergen|Atopy patches used with food lyophilized allergen and commercial allergen were placed on back of subjects for 48 hrs then atopy patches were taken off. Subjects should return to evaluate the reaction one day later (72 hr after applying atopy patch test)
16229771|NCT01164280|Other|Pulse Rate Change|Different pulse rate settings of the implantable neurostimulator
16229772|NCT01164267|Drug|Everolimus|Everolimus (tablets, 5 mg) is given orally at the dose of 10 mg/day from day 1 to day 28 of each cycle for up to a total of 6 cycles or until progression. Patients with CR or PR may continue treatment until PD if well tolerated
16229773|NCT01164228|Drug|Gemcitabine|Given IV
16229774|NCT01164228|Drug|Sunitinib|Given PO
16229775|NCT01164215|Drug|fluorouracil|200-400 mg/m2 intravenously, 1 -5 minutes, once every 2 weeks 2400 mg/m2 intravenously over a period of 46 hours, once every 2 weeks
16229776|NCT01164215|Drug|leucovorin|200-400 mg/m2, intravenously over a period of 2 hours, once every 2 weeks
16229777|NCT01164215|Drug|oxaliplatin|85 mg/m2, intravenously for 2 hours, once every 2 weeks
16229778|NCT01164202|Drug|sunitinib malate|placebo 3cps/days 4 weeks over 6 during 1 year
16229779|NCT01164202|Drug|Placebo|placebo 3cps/days 4 weeks over 6 during 1 year
16229780|NCT01164202|Procedure|transarterial chemoembolization|Chimioembolisation
16229781|NCT01164189|Biological|Bevacizumab|Bevacizumab (vial of 400mg/16mL) at a dose of 10 mg/kg bodyweight i.v. in 90 min on day 1 and day 14 of 4 week cycles
16229782|NCT01164189|Drug|Temozolomide|Temozolomide (250, 100, 20 and 5 mg caps) will be administered orally on day 1-5, 150-200 mg/m², and will be repeated every 4 weeks. This will be repeated for up to 12 cycles.
16229783|NCT01164176|Drug|everolimus|
16229784|NCT01164176|Other|laboratory biomarker analysis|
16229785|NCT01164163|Drug|ruxolitinib phosphate|
16229786|NCT01164163|Other|laboratory biomarker analysis|
16229787|NCT01164163|Other|pharmacological study|
16229788|NCT01164150|Radiation|45 Gy/25 fractions|Arm A 45 Gy/25 fractions pelvic radiotherapy using 3D planned technique followed by 11Gy/2 fractions vaginal vault brachytherapy
16229789|NCT01164137|Behavioral|Medication Reconciliation|A pharmacist-led home intervention conducted within 72 hours of hospital discharge aimed at correcting and identifying medication discrepancies.
16229790|NCT01164124|Dietary Supplement|Probiotic supplementation (Lactobacillus rhamnosus GG and Bifidobacterium infantis)|The probiotic regimen consisted of 500 million CFU of Lactobacillus rhamnosus GG (Culturelle, Amerifit Brand Inc.) and 500 million CFU of Bifidobacterium infantis (Align, Procter & Gamble.Inc)
16229791|NCT01164124|Other|Placebo|routine feedings
16229792|NCT01164111|Other|Preoperative resistance training|preoperative resistance training: Duration 8 weeks. Intensity: 3 sets of 80 % of 1 repetition max (1 RM) in each exercise (stated as 8-10 repetitions of the exercise). Frequency: 2 times/week. The patient follows a special training program consisting of exercises with knee and hip extension. Training intensity is followed in a personalized log-book for each patient. Sessions are conducted in small teams closely supervised by specially trained physiotherapists.
16229793|NCT01164098|Drug|Rituximab|Induction therapy
16229794|NCT01164085|Drug|Intravitreal Ketorolac|4mg of intravitreal ketorolac
16229795|NCT01164059|Drug|Olanzapine|Olanzapine 10, 15, or 20 mg / day
16229796|NCT01164059|Drug|Flupentixol|Flupentixol 6, 9, or 12 mg / day
16229797|NCT01164059|Drug|Quetiapine|Quetiapine 400, 600, or 800 mg / day
16229798|NCT01164059|Drug|Aripiprazole|Aripiprazole 10, 15, or 20 mg / day
16229799|NCT01164059|Drug|Haloperidol|Haloperidol 3, 4.5, or 6 mg / day
16229800|NCT01164046|Drug|low molecular weight heparin|weight adjusted dose of low molecular weight heparin, any type allowed if approved, 65-75% of full therapeutic dose
16229801|NCT01164046|Drug|vitamin K antagonists|Target INR between 2-3. Any type allowed, if approved for use in that country.
16229802|NCT01164033|Drug|RO5045337|single oral dose
16229803|NCT01164020|Dietary Supplement|creatine supplementation|20g/d for 7 days followed by 5g/d for 23 weeks
16229804|NCT01164020|Other|Placebo (Dextrose)|20g/d for 7 days followed by 5g/d for 23 weeks
16229805|NCT01164020|Other|Resistance training|resistance training twice a week for 24 weeks
16229806|NCT01164007|Drug|Bevacizumab|Bevacizumab will be given as 10 milligrams per kilogram (mg/kg) via intravenous (IV) infusion on Days 1 and 14 of each 28-day cycle.
16229807|NCT01164007|Drug|Dacarbazine|Dacarbazine will be given as 800 milligrams per square meter (mg/m^2) via IV infusion on Day 1 of each 28-day cycle.
16229808|NCT01163994|Drug|ceftriaxone|intravenously, 2 g, qd, 15 days
16229809|NCT01163994|Drug|doxycycline|orally, 100 mg, bid, 15 days
16229812|NCT01163968|Behavioral|MOMENTUM|The Maximizing Outcomes Needed After Percutaneous Coronary Intervention (PCI) Using Weight Management (MOMENTUM) intervention is comprised of 6 modules, totaling 52 daily sessions promoting weight reduction, and 4 coaching sessions over the duration of the 12 week MOMENTUM intervention. The MOMENTUM intervention will be delivered using telehealth methods (Viterion telehealth device will be used to deliver the module content and coaching sessions). The intervention was purposively designed to overcome access barriers by using delivery modes accessible to patients in rural settings, in their home and at times convenient to their schedule.
16229813|NCT01163955|Other|Time to fatigue|5 minutes while playing video games
16229814|NCT01163942|Drug|G-CSF|Yes/no addition of G-CSF
16229815|NCT01163942|Drug|Early retreatment with ATG|Yes/no early retreatment with ATG
16229816|NCT01163929|Drug|paclitaxel|"Paclitaxel:
~80mg/m2 IV TRO 3 hours every 28 days for 4 cycles
~Trastuzumab:
~4mg/kg IV load dose (TRO 90) minutes followed by 2 mg/kg TRO 60 minutes every week for 18 weeks
~Everolimus: 10mg PO daily 16-18 weeks"
16229817|NCT01163903|Drug|pantoprazole sodium for injection|Single 3-weekly doses of pantoprazole using the following dose escalation scheme for successive groups of patients: 80, 160, 240 and 320mg i.v. of pantoprazole to be given every 3 weeks, 30-60 (±5) minutes prior to doxorubicin. Treatment will be repeated on Day 1 of a 21-day cycle until radiographic or symptomatic progression or unacceptable toxicity or a maximum of 4 cycles (for patients who have received prior anthracyclines), and up to 8 cycles (for those with no prior exposure to anthracyclines).
16229818|NCT01163903|Drug|doxorubicin hydrochloride injection|60 mg/m2, IV, scheduled on day 1 of every 3-week interval, 30-60 (±5) minutes after pantoprazole administration.
16229819|NCT01163890|Behavioral|Work and Health Initiative|Telephone-based multi-modal intervention, consisting of: vocational coaching, cognitive-behavioral therapy strategies and care coordination strategies provided by specially-trained EAP counselors
16229820|NCT01163890|Behavioral|Usual Medical or Behavioral Intervention|Referral to treatment as usual through personal physician, mental health professional, behavioral health program, and/or Employee Assistance Program
16229821|NCT01163877|Dietary Supplement|Fe-57 orally, Fe-58 intravenously|Subjects will receive a test drink containing 3 mg Fe-57 in the form of labelled FeSO4 followed by 1 ml of an aqueous solution containing 50 μg Fe-58 as iron citrate.
16229822|NCT01163864|Behavioral|affect regulation training|8 sessions of a 1-hour long treatment intended to help women deal more effectively with negative affect; cognitive-behavioral smoking cessation intervention
16229823|NCT01163864|Behavioral|health and lifestyle|8 sessions of a 1-hour long treatment designed to help women improve their overall health; cognitive-behavioral smoking cessation intervention
16229824|NCT01163851|Biological|4 mg/kg|RN316 10 mg/ml vial sd. Infusion based on weight Infusion duration = 60 minutes.
16229825|NCT01163851|Biological|0.5 mg/kg|RN316 10 mg/ml vial sd. Infusion based on weight Infusion duration = 60 minutes.
16229826|NCT01163838|Biological|Placebo|Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
16229827|NCT01163838|Biological|1 mg/kg every 2 weeks|Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
16229828|NCT01163838|Biological|2 mg/kg every 4 weeks|Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
16229829|NCT01163838|Biological|4 mg/kg every 4 weeks|Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
16229830|NCT01163838|Biological|4 mg/kg every 8 weeks|Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
16229831|NCT01163838|Biological|8 mg/kg every 8 weeks|Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
16229832|NCT01163838|Biological|12 mg/kg every 8 weeks|Subjects will receive placebo or active treatment every 2 weeks for a total of 9 doses. Duration of IV infusion is 60 minutes. Total dose is based on subjects weight.
16229833|NCT01163825|Drug|Nerve Growth Factor|Encapsulated cell biodelivery of Nerve Growth Factor (NGF) to the basal forebrain nuclei of the brain by multiple implantable devices housing NGF-secreting human cells
16229834|NCT01163812|Procedure|Laparoscopic D2 distal gastrectomy|"Under general endotracheal anesthesia, Five or six ports are used. Lymph node dissection and ligation of vessels are carried out in the laparoscopic field. A partial omentectomy encompassing perigastric nodes is performed laparoscopically. D2 lymphadenectomy is carried out according to the guidelines of the The Japanese Research Society for Gastric Cancer for the corresponding location of the primary tumor. A 5- to 6-cm small incision is made transversely in RUQ of the abdomen. Through the incisional window, the stomach is removed from the abdominal cavity and resected. A Billroth-I gastroduodenostomy using an EEA stapler and GIA or a Billroth-II gastrojejunostomy with a hand-sewing technique is performed. The abdomen is then closed after hemostasis is achieved."
16229835|NCT01163799|Drug|Alefacept (ASP0485)|Withdrawal of calcineurin inhibitor at 30 days post-transplant. Administer Alefacept 7.5 mg post-op day 0, post-op day 2 given IV; Alefacept 15 mg SQ X 12 weeks, then monthly until Month 12.
16229836|NCT01163786|Drug|Bortezomib|Each patient will receive 2 cycles of Bortezomib. For each cycle Bortezomib wil be given once a week, 1.3mg/m2 for 4 weeks with 2 weeks between each cycle.
16229837|NCT01163773|Other|MILK|"Consumption of the 2 experimental diets
~Milk diet
~Control diet"
16229838|NCT01163760|Device|etafilcon A|daily disposable contact lens
16229839|NCT01163760|Device|ocufilcon D|daily disposable contact lens
16229840|NCT01163747|Biological|tocilizumab|Intravenous repeating dose
16229841|NCT01163747|Drug|methotrexate|A stable dose of between 7.5 and 25 mg/week, oral or parenteral.
16229842|NCT01163747|Biological|23-Valent Pneumococcal Polysaccharide Vaccine|Intramuscular or subcutaneous injection
16229843|NCT01163747|Biological|Tetanus Toxoid Adsorbed Vaccine|Intramuscular injection
16229844|NCT01163734|Drug|Ranolazine|Intravenous treatment followed oral treatment for 13 days.
16229845|NCT01163734|Other|Saline 0.9% and placebo tablet|Intravenous treatment followed by oral treatment for 13 days
16229846|NCT01163721|Drug|Ranolazine|Ranolazine ER 1000 mg (two 500 mg tablets) administered orally twice daily
16229847|NCT01163721|Drug|Placebo|Placebo to match ranolazine administered orally twice daily
16229848|NCT01163708|Device|Prophecy Technique|Navigation computerised system is used intraoperatively to correct implant the Advance knee implant. Prophecy is a pre-alignment technique where a pre-op MRI or CT scan is used to manufacture personalised cutting blocks to assist the surgeon in correct implanting the Advance knee implant intraoperatively
16229849|NCT01163708|Device|Navigation System|
16229850|NCT01163695|Behavioral|Children's development account|Children in the experimental condition (the SUUBI program) received, in addition to the usual care, an economic empowerment intervention aimed at promoting asset accumulation for families-and consisting of three major components: 1) workshops focused on asset-building and future planning; 2) a monthly mentorship program for adolescents with peer mentors on life options; and 3) a Child Development Account (CDA), dedicated to paying for secondary schooling, vocational training and/or a family small business. The CDAs were matched savings accounts, with a match rate of 2:1 as an incentive for participants to save, but with a limit on the maximum savings that could be matched (the match cap, in this case, was equivalent to $10 a month).
16229851|NCT01163682|Other|Electro-acupuncture|Subjects will be placed in prone position and acupuncture sites will be cleaned with alcohol preparation. Stainless steel disposable acupuncture needle (diameter 0.25mm) will be inserted into the skin to appropriate depth needed to elicit de qi(approximately 3-4mm). Selected acupuncture points will be attached to2 leads connected to an electro-stimulator that generates 2 Hz of mixed pulsatile intervals for a total of 30 minutes. The acupuncturist will return two times during the treatment at 10 and 20 minutes with needles in situ to check on the patients and needles. Needles not attached to the electro-stimulator will be manipulated manually to elicit de qi one time during the treatment.
16229852|NCT01163682|Other|Sham acupuncture|Will be utilizing a sham control that consists of collapsible acupuncture needle so that there is no penetration of skin. The sham needles will be place on 4 non specific body points. The elecrto-stimulator will be attached to the needles for 30 minutes but will not be turned on. The acupuncturist will return two times during the treatment at 10 and 20 minutes to check on the patient. The acupuncturist will touch the collapsible acupuncture needs to simulate the manipulation of the needles.
16229853|NCT01163656|Device|Miller Laryngoscope|Device is used to facilitate tracheal intubation.
16229854|NCT01163656|Device|Glidescope Cobalt Video Laryngoscopes|The laryngoscope design with the integration of video technology into the laryngoscope blade.
16229855|NCT01163643|Drug|0.3% BOL-303242-X ophthalmic suspension|0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks.
16229856|NCT01163643|Drug|2% BOL-303242-X ophthalmic suspension|2% BOL-303242-X ophthalmic suspension BID for 12 weeks.
16229857|NCT01163643|Drug|Placebo Comparator: Vehicle|Placebo Comparator: Vehicle BID for 12 weeks.
16229858|NCT01163643|Drug|1% BOL-303242-X ophthalmic suspension|1% BOL-303242-X ophthalmic suspension BID for 12 weeks.
16229859|NCT01163643|Drug|2% BOL-303242-X ophthalmic suspension AM|2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks.
16229860|NCT01163643|Drug|2% BOL-303242-X ophthalmic suspension PM|Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks.
16229861|NCT01163630|Drug|esomeprazole/ASA Fixed Dose Combination (FDC)|esomeprazole 20 mg/ASA 81 mg oral capsule
16229862|NCT01163617|Device|Adalimumab delivered in current syringe|Pre-filled currently approved glass syringe containing 40 mg/0.8 mL adalimumab to be injected subcutaneously
16229863|NCT01163617|Device|Adalimumab delivered in Physiolis syringe|Pre-filled Physiolis glass syringe containing 40 mg/0.8 mL adalimumab to be injected subcutaneously
16229864|NCT01163617|Device|Adalimumab delivered in current autoinjector|Pre-filled currently approved autoinjector containing 40 mg/0.8mL adalimumab to be injected subcutaneously
16229865|NCT01163617|Device|Adalimumab delivered in Physiolis autoinjector|Pre-filled Physiolis autoinjector containing 40 mg/0.8 mL adalimumab to be injected subcutaneously
16229866|NCT01163604|Drug|Argatroban|Intravenous Infusion, 20mg/day for 2 days before and 3 days after stenting, (10mg/3h, twice a day), with accompanied aspirin and clopidogrel treatment
16229867|NCT01163604|Drug|non-argatroban treated group|Patients who underwent intracranial and extracranial artery stenting were randomly chosen to receive only aspirin and clopidogrel treatment.
16229868|NCT01163565|Device|Ligasure Device|Ligasure device used to seal blood vessels during left or right side of a total thyroidectomy. Traditional method of hand ties/clips on contralateral side.
16229869|NCT01163552|Procedure|Surgical debulking and Intrathoracic Hyperthermic Chemotherapy|Surgical debulking of intrathoracic metastases will be performed, followed by perfusion of the chest with heated Cisplatin for 60 minutes.
16229870|NCT01163526|Procedure|CT perfusion|
16229871|NCT01163500|Dietary Supplement|Coenzyme Q10|coenzyme Q10 supplements 60 mg/day and 150 mg/day
16229872|NCT01163500|Other|Placebo|Placebo controlled (dextrin)
16229873|NCT01163487|Drug|Dichloroacetate|25-50mg/kg per day; oral
16229874|NCT01163487|Device|EF5|21 mg/kg; IV
16229875|NCT01163474|Other|Evaluate video clinic visit prior to Face-to-Face usual care visit|Evaluate video clinic visit prior to Face-to-Face usual care visit
16229876|NCT01163461|Behavioral|speech therapy|individuals will receive 60 hours of behavioral speech therapy
16229877|NCT01163448|Radiation|High-Dose Single-Fraction Image-Guided Radiotherapy for Men Undergoing Radical Prostatectomy|A baseline DCE-MRI will be obtained prior to the day of radiotherapy treatment. Immediately following the delivery of radiotherapy another DCE-MRI will be performed to assess for perfusion changes in the prostate resulting from irradiation. RP will be completed within 6 weeks (+ 2 weeks) of radiation and the RP specimen will be assessed for radiation treatment effect and other pathologic parameters (including surgical margin status) by a dedicated genitourinary pathologist. Following RP, participants will follow-up with their surgeon every 3 months for one year, with visits alternating between the urologist and the radiation oncologist. After the first year follow-up will occur at 6 month intervals until the patient is 3 years out from surgery.
16229878|NCT01163435|Drug|high dose dual therapy|rabeprazole 20 mg qid,amoxicillin 750 mg qid for 14 days
16229879|NCT01163435|Drug|sequential therapy|rabeprazole 20 mg, amoxicillin 1000 mg, bid for 5 days, then rabeprazole 20 mg , metronidazole 500 mg, clarithromycin 500 mg, bid for next 5 days
16229880|NCT01163435|Drug|clarithromycin-based triple therapy|rabeprazole 20 mg, amoxicillin 1000 mg, clarithromycin 500 mg, bid for 7 days
16229881|NCT01163435|Drug|levofloxacin-based triple therapy|rabeprazole 20 mg, amoxicillin 1000 mg, levofloxacin 250 mg, bid for 7 days
16229882|NCT01163422|Device|Implantation of 3-chamber pacemaker|Implantation of pacemaker with leads in right atrium, right ventricle, and coronary sinus (left ventricle) with the aim of providing right ventricular resynchronization therapy (RVRT); this is accomplished by pacing the right ventricle ahead of the left ventricle, e.g., by setting (shortening) the A-V delay between right atrium and right ventricle to an optimal level.
16229883|NCT01163409|Procedure|exercise training|exercise training comprises aerobic and strength training
16229884|NCT01163409|Procedure|acupuncture|acupuncture involves two sessions per week, during 14 weeks.
16229885|NCT01163409|Procedure|Exercise, Acupuncture and Fibromyalgia|Set of real acupuncture treatment and supervised aerobic exercise have better efficacy in pediatric patients with fibromyalgia versus treatment with sham acupuncture and supervised aerobic exercise, as well as treatment versus combination with aerobic exercise and resistance exercise the major muscle groups, both supervised versus group control, we just get guidance for physical activity.
16229886|NCT01163396|Drug|Bevacizumab|
16229887|NCT01163396|Drug|Irinotecan|
16229888|NCT01163396|Drug|Oxaliplatin|
16229889|NCT01163396|Drug|5-fluorouracil/leucovorin|
16229890|NCT01163383|Drug|131 I-Metaiodobenzylguanidine (131 I-MIBG)|131 I-MIBG 1-18mCi/kg given intravenously on day 1. Subjects may receive multiple courses every 4-8 weeks depending on the dose given.
16229891|NCT01163383|Drug|131 I-MIBG|131-I-MIBG will be infused intravenously over 60-90 minutes once per course. The dose will be determined by the treating physician.
16229892|NCT01163370|Dietary Supplement|creatine supplementation|20g/d for 7 days followed by 5g/d for 23 weeks
16229893|NCT01163370|Other|exercise training|resistance training twice a week for 24 weeks
16229894|NCT01163370|Other|placebo (dextrose)|20g/d for 7 days followed by 5g/d for 23 weeks
16229895|NCT01163357|Drug|bortezomib|Given IV
16229896|NCT01163357|Drug|fludarabine phosphate|Given IV
16229897|NCT01163357|Other|melphalan|Given IV
16229898|NCT01163357|Radiation|total marrow irradiation|Undergo TMI
16229899|NCT01163357|Drug|tacrolimus|Given IV and orally
16229900|NCT01163357|Drug|sirolimus|Given orally
16229901|NCT01163357|Procedure|peripheral blood stem cell transplantation|Undergo allogeneic PBSC transplant
16229902|NCT01163357|Other|laboratory biomarker analysis|Correlative studies
16229903|NCT01163331|Other|Singing Therapy|Singing therapy as a way to improve voice quality
16229904|NCT01163305|Drug|Chemotherapy|The majority of patients offered either oxaliplatin or irinotecan-based chemotherapy
16229905|NCT01163279|Behavioral|Real world strategy approach|The key features of the protocol are: i. Participants are actively engaged in selecting their treatment goals. The research clinician will work with the participants to identify five specific, measurable real-world goals using a standardized semi-structured interview, the Canadian Occupational Performance Measure. Three of these will be training goals, two will not be trained but evaluated post-intervention for evidence of generalization and transfer to non-trained tasks; ii. A global problem solving approach is used (Goal- Plan- Do- Check). Participants are guided by the trainer to apply this strategy to their goals.
16229906|NCT01163279|Behavioral|Psychosocial Education|The active comparator uses an information-based format and is designed to engage participants without providing any specific training techniques or strategies. During weekly sessions, participants will receive factual information on brain structure and function, age-related cognitive changes, and general brain health issues and will spend time doing non-specific cognitive exercises including crossword and Sudoku puzzles. Homework will consist of reading assignments related to the session topics.
16229907|NCT01163266|Drug|Vortioxetine|Encapsulated vortioxetine immediate release tablets
16229908|NCT01163266|Drug|Placebo|Vortioxetine placebo-matching capsules
16229909|NCT01163253|Drug|CP-690,550|5 mg oral BID
16229910|NCT01163253|Drug|CP-690,550|10 mg oral BID
16229911|NCT01163227|Drug|Placebo (single and multiple doses)|
16229912|NCT01163227|Drug|AQW051 2 mg (single and multiple doses)|
16229913|NCT01163227|Drug|AQW051 15mg (single and multiple doses)|
16229914|NCT01163227|Drug|AQW051 100mg (single dose), and 50mg (multiple doses)|
16229915|NCT01163214|Drug|Nerve Block|Regional anesthetic nerve block using an indwelling femoral nerve catheter and a single shot sciatic nerve block using 0.5% ropivacaine.
16229916|NCT01163214|Drug|Periarticular Injection|Periarticular local injection into the periarticular soft tissues at the time of knee replacement using a combination of ropivacaine, epinephrine, ketorolac, and morphine sulphate. Subjects in this arm received the injection combination based on three subject weight categories.
16229917|NCT01163201|Biological|Treg cells|Given by infusion on Day 0 after transplantation - Five doses of Treg (3 x 10^6/kg, 10 x 10^6/kg, 30 x 10^6/kg, 100 x 10^6/kg and 300 x 10^6/kg)
16229918|NCT01163201|Biological|CD3+ Teff cells|Given by infusion on Day 0 after transplantation - 5 doses of CD3+ Teff cells (3 x 10^6 cells/kg, 6 x 10^6 cells/kg, 9 x 10^6 cells/kg, 12 x 10^6 cells/kg, and 15 x 10^6 cells/kg with the latter dose representing the median number of CD3+ cells in two UCB unit grafts
16229919|NCT01163201|Drug|Fludarabine|Given intravenously on Days -8 through -6, 25 mg/m^2 over 1 hour
16229920|NCT01163201|Drug|Cyclophosphamide|Given intravenously on Day -7 and -6, 60 mg/kg
16229921|NCT01163201|Radiation|Total body irradiation|Given on Days -4 through -2, 165 cGY twice a day.
16229922|NCT01163201|Biological|Umbilical cord blood transplantation|Infusion given on day 0
16229923|NCT01163175|Other|Ruminant trans fats|"Consumption of the 4 experimental diets:
~a diet rich in ruminant TFA (8 g/day);
~a diet moderately rich in ruminant TFA (4 g/day);
~a diet rich in industrial TFA (8 g/d);
~a control diet (minimal dietary TFA of industrial and ruminant sources)."
16229924|NCT01163162|Drug|Paricalcitol|2 mcg oral Paricalcitol once per day for 7 days
16229925|NCT01163149|Drug|asfotase alfa|Cohort 1: Daily SC injections of 0.3 mg/kg asfotase alfa (total of 2.1 mg/kg/week)
16229926|NCT01163149|Drug|asfotase alfa|Cohort 2: Daily SC injections of 0.5 mg/kg Asfotase Alfa (3.5 mg/kg/week total)
16230459|NCT01158820|Drug|Midazolam load|2 mg bolus prior to bronchoscopy
16229927|NCT01163110|Dietary Supplement|Realbuild|Patient with chemotherapy induced thrombocytopenia takes RNA fragments orally to accelerate time to platelet recovery
16229928|NCT01163097|Drug|Palifermin|40 µg/kg IV bolus injections for three consecutive days
16229929|NCT01163097|Drug|Heparin|Heparin continuous IV infusion
16229930|NCT01163084|Drug|Goserelin Acetate|Given SC
16229931|NCT01163084|Other|Laboratory Biomarker Analysis|Correlative studies
16229932|NCT01163084|Drug|Leuprolide Acetate|Given IM
16229933|NCT01163084|Drug|Vismodegib|Given PO
16229934|NCT01163071|Drug|ABI-011|ABI-011
16229935|NCT01163045|Procedure|thyroidectomy|total thyroidectomy and lobectomy
16229936|NCT01163032|Drug|tasimelteon|20 mg tasimelteon capsules, PO daily for 6 months
16229937|NCT01163032|Drug|Placebo|Placebo capsules, PO daily for 6 months
16229938|NCT01163006|Other|Polydextrose and soluble gluco fibre|Polydextrose and soluble gluco fibre
16229939|NCT01162993|Procedure|Spinal Cord Stimulation|The intervention is spinal cord stimulation and will be used for 2 weeks trial stimulation. After clinical successful pain relief (≥50% relief of pain intensity on a weighted numeric rating scale (NRS) or a score of ≥6 on a seven-point Likert scale (1=very much worse; 7=very much improved) of the PGIC scale for pain and sleep) a definite spinal cord system will be implanted.
16229940|NCT01162967|Drug|Benznidazole|Standard dosage
16229941|NCT01162967|Drug|Posaconazole|
16229942|NCT01162954|Drug|DA-6034|
16229943|NCT01162954|Drug|Placebo|
16229944|NCT01162941|Other|Steroid refractory ITP|a platelet count less than 20X109/L despite of treatment with full dose of steroid (prednisolone 1mg/kg for at least 4 weeks)
16229945|NCT01162928|Drug|Nutriflex Omega special + Oxepa|3-chamber-bag combined with enteral nutrition
16229946|NCT01162928|Drug|Nutriflex Lipid special + Pulmocare|3-chamber-bag combined with enteral nutrition
16229947|NCT01162915|Biological|Autologous bone marrow-derived mesenchymal stem cells.|Intrathecal infusion of a single dose of ex vivo expanded MSC.
16229948|NCT01162902|Drug|Diltiazem treated group|Diltiazem 180mg for 9 months
16229949|NCT01162902|Drug|Bisoprolol treated group|Bisoprolol 5mg for 9 months
16229950|NCT01162902|Drug|Candesartan treated group|Candesartan 32mg for 9 months
16229951|NCT01162889|Drug|Placebo SC Injection|Single injection
16229952|NCT01162889|Drug|ATR-107 (PF-05230900) SC Injection|Single intravenous infusion, 60 minute duration
16229953|NCT01162889|Drug|ATR-107 (PF-05230900) SC Injection|Single subcutaneous injection
16229954|NCT01162889|Drug|ATR-107 (PF-05230900) SC Injection|Single subcutaneous injection
16229955|NCT01162889|Drug|ATR-107 (PF-05230900) SC Injection|Single subcutaneous injection
16229956|NCT01162889|Drug|ATR-107 (PF-05230900) SC Injection|Single subcutaneous injection
16229957|NCT01162889|Drug|ATR-107 (PF-05230900) IV Infusion|Single subcutaneous injection
16229958|NCT01162889|Drug|ATR-107 (PF-05230900) IV Infusion|Single intravenous infusion, 60 minute duration
16229959|NCT01162889|Drug|ATR-107 (PF-05230900) IV Infusion|Single intravenous infusion, 60 minute duration
16229960|NCT01162889|Drug|Placebo IV Infusion|Single intravenous infusion, 60 minute duration
16229961|NCT01162889|Drug|ATR-107 (PF-05230900) IV Infusion|Single intravenous infusion, 60 minute duration
16229962|NCT01162876|Drug|saxaglipitin|oral administration of 5 mg tablet before breakfast for 14 consecutive days
16229963|NCT01162863|Drug|Lubiprostone|lubiprostone taken either at a dose of 8 mcg orally twice daily (BID) for 28 days or 24 mcg orally once daily (QD) for 28 days
16229964|NCT01162863|Drug|Placebo|taken orally for 28 days
16229965|NCT01162863|Other|Smartpill wireless motility capsule|Ingestion of a small non-digestible capsule that measures temperature, pH and pressure of the immediate surrounds as it passes through the GI tract eventually exiting the body through the anus
16229966|NCT01162850|Dietary Supplement|Polypodium Leucotomos|Oral capsule at 240 mg taken twice a day for 12 weeks
16229967|NCT01162850|Dietary Supplement|Placebo|240 mg Placebo taken orally twice daily created by company which manufactured active ingredient
16229968|NCT01162837|Device|BEAM device|A red/blue LED device for the treatment of acne
16229969|NCT01162824|Drug|Acetylcholine|Incremental doses of 2, 20 and 100 µg of ACH will be injected into the left coronary artery (LCA) via the diagnostic catheter for 3 minutes each. After that 80 µg of ACH will be injected into the right coronary artery. Coronary angiography will be performed after each 3 minute dose period. After the test or when intolerable chest pain due to coronary spasm occurs, 0.2 mg of glyceryltrinitrate will be injected into each vessel. During the test, heart rate, blood pressure and ECG will be monitored continuously.
16229970|NCT01162824|Drug|Adenosine|Coronary blood flow velocity measurements will be performed in the mid segment of the left anterior descending artery with a 0.014-in intracoronary Doppler guidewire connected to the corresponding interface. Measurements will be obtained after the administration of nitroglycerin, at baseline and during maximal hyperaemia. Sustained intravenous administration of adenosine - an arteriolar vasodilator- will be used to induce maximal hyperaemia (140-180µg/kg/min).
16229971|NCT01162811|Behavioral|visualization together with structured behavioural attention.|visualization and relaxation exercises together with structured behavioural attention.
16229972|NCT01162798|Other|infant formula|test infant formula fed to infants until 6 months corrected gestational age
16229973|NCT01162798|Other|control infant formula|commercially available infant formula
16229974|NCT01162785|Drug|SCH 721015|Intravesical SCH 721015 (on Day 1 and 4) at a dose concentration of 3x1011particles/mL given in a 75 mL total volume. Administered into bladder through a urinary catheter, 75 mL will be instilled, left in the bladder for 1 hour, plus or minus 10 minutes. During the dwell time, subject will be repositioned from left to right, back and abdomen to maximize bladder surface exposure, approximately every 15 minutes.
16229975|NCT01162759|Behavioral|Home Blood Pressure Monitoring|Home blood pressure readings are taken at least 3 times a week, uploaded to a Microsoft Health Vault account through American Heart Association Heart360 at least 1 time per week. Patients are followed by a clinical pharmacist, with physician oversight, who will make adjustments to antihypertensive medications or suggest additional medications using national JNC VII and KPCO hypertension guidelines.
16230144|NCT01161212|Other|Physical education sessions|1 (3 hours) or 2 long PE sessions (1 hour and 30 minutes each)
16229976|NCT01162746|Drug|Intravitreal dexamethasone and intravitreal ranibizumab|"Patients will receive intravitreal dexamethasone using a special drug delivery system and same day intravitreal ranibizumab.
~Study medications are initially given at the baseline visit. At each subsequent monthly follow-up visit, ranibizumab is administered if further visual decrease or persistence of sub-/intraretinal fluid is detected in the examination. At month 3, 6, 9 and 12 further treatments with intravitreal dexamethasone in combination with intravitreal ranibizumab are given if leakage is detected in fluorescein or indocyanine green (FLA or ICG) angiography, in case of further vision decrease or persistence of sub-/intraretinal fluid in OCT."
16229977|NCT01162746|Drug|Intravitreal ranibizumab|Patients will receive intravitreal ranibizumab monotherapy (cohort 3). Study medications are initially given at the baseline visit. At each subsequent monthly follow-up visit, ranibizumab is administered if further visual deterioration or persistence of sub-/intraretinal fluid is detected in the examination
16229978|NCT01162733|Drug|Vancomycin|15mg/kg
16229979|NCT01162733|Drug|Vancomycin|30mg/kg
16229980|NCT01162720|Procedure|Long duration tourniquet|Patients randomised to this arm will have the tourniquet applied at the commencement of surgery and removed prior to wound closure.
16229981|NCT01162720|Procedure|Short duration tourniquet|Patients assigned to this arm will have the tourniquet applied during cement fixation of the prosthesis only (ie removed just prior to wound closure).
16229982|NCT01162707|Device|CardioMEMS HF Pressure Measurement System|Implant sensor into the left or right pulmonary artery. Measure pulmonary artery pressure
16229983|NCT01162694|Other|Remote Blood Glucose Monitoring|The subjects enrolled in the Internet Therapeutic Intervention arm receive standard care by testing their blood glucose at least 3 times daily and visit the endocrinologist every 3 months; however, they are also asked to upload their blood glucose readings online every 2 weeks for the health practitioner to view and comment upon.
16229984|NCT01162694|Other|Continuous Glucose Monitoring|The use of CGMS (Sensor, receiver, transmitter) (Medtronic Diabetes) plus the uploading of results to the Internet-based software utility of CareLink Personal and generating reports that can be viewed and used at the patient's own preference. This group will not receive feedback or suggestion based on the uploaded glucose data.
16229985|NCT01162681|Drug|A-623|High dose given subcutaneously once a week for up to 52 weeks
16229986|NCT01162681|Drug|A-623|Low dose given subcutaneously once a week for up to 52 weeks
16229987|NCT01162681|Drug|A-623|High dose given subcutaneously once every 4 weeks for up to 52 weeks
16229988|NCT01162681|Other|Placebo Comparator|Placebo comparator is a matched volume given subcutaneously once a week or once every 4 weeks for up to 52 weeks
16229989|NCT01162655|Behavioral|Cognitive-behavioral therapy for Insomnia (CBT)|6-week course of CBT delivered either using internet or telehealth
16229990|NCT01162642|Dietary Supplement|Green Tea|Green Tea 4 cups daily
16229991|NCT01162642|Other|Placebo|4 cups placebo tea for 6 weeks
16229992|NCT01162629|Device|Osteon bone graft|Osteon bone substitute placed to a height of 2 mm above the top of the dental implant
16229993|NCT01162616|Dietary Supplement|labeled iron solutions|labeled iron as 2 mg 58FeSO4, 57FeSO4 or 54FeSO4 per test portion (50g sorghum) 2 mg labeled iron as NaFeEDTA per test portion (50g sorghum)
16229994|NCT01162603|Device|Goldmann and Perkins applanation tonometry|IOP values will be assessed by the means of Goldmann or Perkins applanation tonometry at the following time-points: 10AM (± 1 hour), 2PM (± 1 hour), 6PM (± 1 hour), 10PM (± 1 hour), 2AM (± 1 hour) and 6AM (± 1 hour) after three months of treatment
16229995|NCT01162603|Drug|TAFLUPROST 0.0015% EYEDROPS|Tafluprost 0.0015% preservative-free ophthalmic solution
16229996|NCT01162603|Drug|LATANOPROST 0.005% EYEDROPS|Latanoprost 0.005% preservative-added ophthalmic solution
16229997|NCT01162590|Biological|Rotarix ™|Oral, single dose
16229998|NCT01162590|Biological|Placebo|Oral, single dose
16229999|NCT01162577|Behavioral|Weight Concerns|Standard Quitline plus weight coaching
16230000|NCT01162564|Device|NG-TSM|Flexible Composite Next Generation Tissue Separating Mesh
16230001|NCT01162551|Drug|Sirolimus and Methotrexate|"Single Arm Efficacy Trial:
~Sirolimus: Oral bolus on day 1, then daily oral dose days 2-28. Dose will be altered to maintain a sirolimus trough level between ≥ 8 and ≤ 13. Trough levels will be checked weekly.
~Methotrexate: Oral 20 mg/m2/week on Days 2, 9, 16, 23.
~One cycle is 28 days."
16230002|NCT01162525|Procedure|Percutaneous tibial nerve stimulation (pTNS)|A 34 gauge needle in placed close to the tibial nerve about 2-3 cm above the ankle. A self-adhesive surface electrode is placed on the skin. Needle and surface electrode are connected to an electric stimulator and the stimulating current (0 - 10 mA) is increased in 20 steps. When the patient feels a tingling sensation in the foot, stimulating current is set back for one step and the treatment is started (30 min stimulation).
16230003|NCT01162512|Behavioral|physical activity|physical activity counseling sessions will occur by telephone weekly for 2 months
16230004|NCT01162499|Drug|Exendin-(9-39)|IV infusion of exendin-(9-39) for 5 hours
16230005|NCT01162499|Other|Vehicle|Normal saline (vehicle) infusion for 5 hours at 0.06 mL/kg/hr
16230006|NCT01162486|Drug|Rifampin & midazolam|rifampin - tablet, 10 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15
16230007|NCT01162486|Drug|rifapentine & midazolam|rifapentine - tablet, 5 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15
16230008|NCT01162486|Drug|rifapentine & midazolam|rifapentine - tablet, 10 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15
16230009|NCT01162486|Drug|rifapentine & midazolam|rifapentine - tablet, 15 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15
16230010|NCT01162486|Drug|rifapentine and midazolam|rifapentine - tablet, 20 mg/kg, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15
16230011|NCT01162486|Drug|rifapentine and midazolam|rifapentine - tablet, 2.5 mg/kg lower than previously tolerated dose cohort, daily 15 days midazolam - liquid syrup, 15 mg, days 1 and 15
16230012|NCT01162473|Dietary Supplement|Milk Oral Immunotherapy|Subjects will participate in a desensitization protocol over the course of 13 weeks to reach a goal maintenance dose of 8 ounces of cow's milk. Once reaching maintenance, subjects will continue on this dose for 12 additional weeks.
16230013|NCT01162473|Drug|Milk Protein Powder|Milk protein powder will be administered in incremental doses during the desensitization protocol.
16230014|NCT01162473|Other|Food Challenge|
16230460|NCT01158820|Drug|Fentanyl load|50 µg bolus prior to bronchoscopy
16230015|NCT01162460|Drug|Eslicarbazepine acetate (BIA 2-093)|"Week 1 and 2 either 400mg/day Eslicarbazepine acetate (ESL) or 200mg/day Carbamazepine controlled release(CBZ-CR); Week 3 onwards either 800mg/day Eslicarbazepine acetate or 400mg/day CBZ-CR; this dose then to be maintained unless a subject has a seizure.
~Subjects experiencing a seizure will have their assigned treatment dose increased to ESL 1200mg/day or CBZ 800mg/day.
~Should a subject have another seizure, their assigned treatment is to be increased to ESL 1600mg/day or CBZ 1200mg/day.
~Subjects who remain seizure free for 26 weeks at any dose in an Evaluation Period will continue to receive the allocated treatment under double-blind conditions."
16230016|NCT01162421|Biological|adalimumab|Study drug will be provided to participants in Early Adalimumab arm as a sterile, preservative-free solution for subcutaneous injection, contained in a pre-filled syringe housed in a pen device (pre-filled pen). 40 mg of adalimumab will be administered subcutaneously at Baseline and then every other week for 24 months. Adalimumab may be initiated in participants in standard of care (SOC) arm after a minimum of 6 months of treatment recommended by their study doctor.
16230017|NCT01162421|Drug|Methotrexate|Participants in both arms will receive a methotrexate regimen based on local guidelines and their study doctor's judgment.
16230018|NCT01162395|Drug|AZD3514|Patients will be given AZD3514 orally as a single dose, and then multiple once daily dosing following a 5-9 day washout.
16230019|NCT01162382|Device|Transcranial Magnetic Stimulation|Four 100-second trains and then one 65-second train, with 30-second inter-train intervals, at 1 Hz and 120% of the resting motor threshold will be applied over the right dorsolateral prefrontal cortex. Subsequently, twenty-five 30-second trains, with a 30-second inter-train interval, at 10 Hz and 120% of the resting motor threshold will be applied over the left dorsolateral prefrontal cortex.
16230020|NCT01162330|Other|Screening urine and saliva tests for congenital Cytomegalovirus|With consent for the study babies who are referred for further hearing tests will have a urine and saliva sample sent to be analysed for CMV infection
16230021|NCT01162317|Other|Acupuncture|Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represents a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes.
16230022|NCT01162317|Other|Sham Acupuncture|Treatments will be performed by the PI, who is a licensed physician acupuncturist and has practiced acupuncture independently for 5 years with about 4000 patient/visit treatment history. A total of 10 acupuncture treatments represent a reasonable approach to optimal duration of treatment. Acupoint selection will be based on a combination of standardization and individualization for best treatment effects. At least 5 standardized body and auricular acupoints will be selected. Standardized sterile, disposable acupuncture needles will be applied for 20 minutes. Each sham or real acupuncture needle will be applied through a tube as sham needles have blunt tip and telescopic shaft, the visual effect and percutaneous sensation of sham needle mimic the real needle penetration.
16230023|NCT01162304|Drug|Extended Release Oxycodone|40 mg tablets one to two every 12 hours, Immediate release 5mg pills 1-2 tablets every 6 hours
16230024|NCT01162304|Drug|Immediate Release Oxycodone|IR oxycodone will be distributed to subjects in 5 mg pills and they will be instructed to take 3-4 of these pills every 4 hours
16230025|NCT01162278|Radiation|SBRT|Single fraction SBRT
16230026|NCT01162252|Behavioral|Mindfulness-Based Stress Reduction|The standardized Mindfulness-Based Stress Reduction (MBSR) program is the primary training tool used to enhance mindfulness. The eight-week-long MBSR program is designed to teach subjects how to develop their inner resources in the service of taking better care of themselves. MBSR training includes the learning and refining of a range of skills aimed at increasing relaxation and awareness of physical experiences and sensations related to physical symptoms, emotions, and thoughts. Special emphasis is placed on movement, meditation, and breathing.
16230027|NCT01162252|Behavioral|Living Well|The Living Well (LW) program involves a series of informational presentations and group discussions on a variety of topics related to the promotion of health and well-being. The 8-week program is designed to provide participants with knowledge about ways to improve their physical and emotional health as a complement to traditional medical treatments.
16230028|NCT01162239|Drug|Varenicline|All participants will receive 12 weeks of varenicline treatment at standard dosage of 1 mg bid. Participants in the Extended Relapse Prevention plus varenicline will receive varenicline for up to 40 additional weeks.
16230029|NCT01162239|Behavioral|Initial Individual counseling|Five 90 minute individual counseling sessions to occur during the first 12 weeks of initial treatment.
16230030|NCT01162239|Behavioral|Check-ins with medical staff|Monthly brief (10-15 minutes) meetings with medical staff.
16230031|NCT01162239|Behavioral|Extended Individual Counseling - Health Model|Monthly counseling sessions across a nine month period with content based on a health education model. Each session is 30-45 minutes in duration.
16230032|NCT01162239|Behavioral|Extended Individual Counseling - Relapse Prevention Model|Eleven individual counseling sessions across a nine month period with content based on a relapse prevention model. Each session is 30-45 minutes in duration.
16230033|NCT01162226|Behavioral|gait and balance training program|The intervention will be implemented via three 50-minute training sessions per week for 12 weeks. The games will be played when the subject is receiving the maximum benefit from their anti-parkinsonian medications. The control group and the intervention group will receive weekly telephone calls to inquire about medications and falls. At baseline and end of the 12 weeks, in-home testing will determine stride length and speed; standing balance eyes open and closed on flat and foam surface.
16230034|NCT01162213|Dietary Supplement|Lychee Fruit Extract|placebo or 100, 200 and 600 mg of lychee fruit extract for 2 weeks with one week washout period between treatments 2000 mg of lychee fruit extract given at a single visit
16230035|NCT01162200|Radiation|Stereotactic Body Radiation Therapy|3 dose cohorts. Patients in each dose cohort will all be treated as a single group for dose escalation. The starting dose for the dose escalation portion will be 6 Gy per fraction for 5 fractions (total dose = 30 Gy). Subsequent cohorts of patients will receive an additional 0.5 Gy per treatment (total 2.5 Gy per escalation).
16230036|NCT01162174|Dietary Supplement|Oligonol|
16230188|NCT01160874|Other|Maintenance Wakefulness Test|Sleep latency testing at 10 am, 12 am, 2 pm and 4 pm.
16230037|NCT01162148|Behavioral|Conventional or regular pulmonary rehabilitation program alone|Conventional or regular pulmonary rehabilitation program alone
16230038|NCT01162148|Device|very low load IMT (sham IMT) alone|very low load IMT (sham IMT) alone
16230039|NCT01162148|Device|Conventional or regular pulmonary rehabilitation program + targeted inspiratory resistive or threshold IMT|Conventional or regular pulmonary rehabilitation program + targeted inspiratory resistive or threshold IMT
16230040|NCT01162148|Device|Targeted inspiratory resistive or threshold IMT alone|Targeted inspiratory resistive or threshold IMT alone
16230041|NCT01162135|Drug|Digoxin|"The participants will take study drug digoxin, which is approved by FDA for the treatment of CHF, 125 or 250 mcg orally daily, titrated to the level of 0.8 - 2 ng/ml for total of 6 cycles (4 weeks/cycle). The lower dose of digoxin (such as 125 mcg/day) will be chosen if serum level reaches 0.8 ng/ml already. Patients may continue another 6 cycles if evident of clinical benefit.
~It is possible that some patients may need to receive 500 mcg per day to reach this targeted drug level. No further titration will be allowed beyond this FDA approved digoxin dose."
16230042|NCT01162122|Biological|MF59 adjuvanted trivalent subunit influenza vaccine (aTIV)|one dose 0.5 mL administered IM in the deltoid muscle of (preferably) the non-dominant arm
16230043|NCT01162122|Biological|Non-adjuvanted trivalent subunit influenza vaccine (TIV)|one 0.5 mL dose administered IM in the deltoid muscle of (preferably) the non-dominant arm
16230044|NCT01162109|Dietary Supplement|Zinc sulfate|"A group of 10 mechanically ventilated patients with severe sepsis will be randomized to receive 500mcg/kg IBW elemental zinc (IV) or placebo. The dose will be escalated by 250mcg/kg IBW every 10 subjects to ceiling dose of 1250 mcg/kg IBW or until toxicity develops.
~A group of healthy volunteers will also receive IV zinc (as a single dose) and the PK will be compared to that in patients with sepsis."
16230045|NCT01162096|Device|Haploidentical Allogeneic Transplantation|Patients undergoing reduced intensity haploidentical hematopoietic stem cell transplant from a partially matched related donor.
16230046|NCT01162070|Other|Free strategy|Free strategy followed in order to make the etiological diagnosis, which means, investigators are free to perform any examination they thought necessary.
16230047|NCT01162070|Other|Standardized strategy|Etiological diagnosis made by following a standardized two-stage strategy: first-line assessment (listed examinations and then examinations directed by the clinical or para-clinical elements of orientation) and second or third-line assessment (examinations directed by the anatomo-clinical type of uveitis).
16230048|NCT01162044|Other|Computer game|Playing with specially designed computer game while in emergency room
16230049|NCT01162031|Drug|Velcade|IV
16230050|NCT01162018|Procedure|acupuncture|The eligible women would be randomized and stratified by sleep problems to two arms: (Acupuncture Arm vs. Sham Acupuncture) with a goal of having 48 patients complete the study (we anticipate about 20% attrition rate). The study interventions will begin after patients completed their treatment. The placebo control for acupuncture will be a validated sham acupuncture control Assessments will be made with daily diaries and with weekly questionnaires. There are ten sessions each lasting approximately 20 minutes. All participants will have PSG data collected.
16230051|NCT01162018|Other|placebo|
16230052|NCT01162005|Drug|Tacrolimus|dosage : 0.1-0.2 mg/kg/day divided two target trough level : 5 - 10 ng/mL Total duration (tacrolimus) : 1 year
16230053|NCT01161992|Genetic|Genetic Analysis|Perform Genome Wide Association Studies.
16230054|NCT01161979|Drug|Zonisamide|Zonisamide capsules 100 mg
16230055|NCT01161979|Drug|Zonegran|Zonegran Capsules 100 mg of EISAI INC
16230056|NCT01161966|Drug|Zonisamide|Zonisamide capsules 100 mg
16230057|NCT01161966|Drug|Zonegran|Zonegran Capsules 100 mg of EISAI INC
16230058|NCT01161953|Genetic|Genetic Analysis|Perform Genome Wide Association Studies.
16230059|NCT01161940|Drug|Nizatidine|Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited
16230060|NCT01161940|Drug|Axid|Axid 300 mg Capsules of Reliant Pharmaceuticals, US
16230061|NCT01161927|Drug|Nizatidine|Nizatidine Capsules 300 mg of Dr.Reddy's Laboratories Limited
16230062|NCT01161927|Drug|Axid|Axid 300 mg Capsules of Reliant Pharmaceuticals, US
16230063|NCT01161914|Drug|Cerezyme®|administered by IV infusion for a dose of 60 U/kg
16230064|NCT01161914|Drug|ISU302|administered by IV infusion for a dose of 60 U/kg
16230065|NCT01161901|Procedure|blood sample|"This study's hypothesis is that patients with ARDS criteria and lobar morphology on CT scan present loss of aeration but no inflammatory pulmonary oedema, whereas patients with non lobar morphology on CT scan present both characteristics.
~The primary purpose of our protocol is to show that the patients who respond to ARDS criteria and have a lobar morphology on CT scan do not have an elevation of the biomarkers specific to the pulmonary aggression of ARDS."
16230066|NCT01161888|Drug|Imiquimod|250mg sachets to be applied at a start dose of 5 days a week. Dose will be adjusted using an algorithm according to tolerability.
16230067|NCT01161875|Device|Neurally Adjusted Ventilatory Assistance|"In ICU following abdominal aortic surgery, in extubated patient, non-invasive ventilation was performed as follows:
~facial mask with non-invasive pressure support ventilation mode to define settings for helmet ventilation
~helmet use with non-invasive pressure support ventilation mode to define adequate settings
~helmet use with neurally adjusted ventilatory assist mode, based on previous settings"
16230068|NCT01161862|Device|Bi-hormonal (insulin and glucagon) artificial pancreas|Subjects wore a bionic pancreas consisting of a continuous glucose monitor, an insulin pump and a glucagon pump
16230069|NCT01161836|Drug|Iniparib|"Solution for infusion
~60-minute intravenous infusion"
16230070|NCT01161810|Other|Routine post burn rehabilitation therapy|No testing outside of routine clinical rehabilitation will be performed
16230071|NCT01161784|Dietary Supplement|Probiotics fermented milk|80ml fermented milk containing min. 30 billion live L. casei Shirota strain, administered orally once a day for 4 weeks
16230072|NCT01161784|Dietary Supplement|Nutrient drink|80ml fermented milk without L. casei Shirota strain, administered orally once a day for 4 weeks
16230073|NCT01161771|Procedure|Cataract Surgery and Limbal relaxing incision|Cataract extraction and limbal-relaxing incisions
16230074|NCT01161758|Other|Passive cervical mobilisation|Passive cervical mobilization which involved an oscillatory grade III unilateral postero-anterior mobilization applied to the left C5/C6 segment. The mobilization consisted of 3 periods of 1 minute applications with a resting period of 1 minute in between.
16230075|NCT01161758|Other|Manual contact|Manual contact control, which involved light manual contact on the left C5/C6 segment as if to perform the treatment technique. The light manual contact consisted of 3 periods of 1 minute applications with a resting period of 1 minute in between.
16230076|NCT01161732|Procedure|Early surgery|Early surgery is performed within 2 months of randomization.
16230077|NCT01161719|Behavioral|parent training|Behavioral management skill training
16230078|NCT01161706|Other|Vegetable Juice|Participants consumed vegetable juice daily in the amount of 0, 8 or 16 fluid ounces.
16230079|NCT01161693|Device|TROOP® elevation pillow|Maternal Comfort after CSE during elective Cesarean Section in relation to adequate height of Anesthetic Block
16230080|NCT01161693|Device|TROOP® elevation pillow|designed by an American bariatric anaesthesiologist Dr Craig Troop, plastic covered foam pillow with an elevation angle of 20 degrees which can simply be placed on the operating table
16230081|NCT01161693|Device|TROOP® elevation pillow|designed by an American bariatric anaesthesiologist Dr Craig Troop, plastic covered foam pillow with an elevation angle of 20 degrees which can simply be placed on the operating table
16230082|NCT01161667|Drug|naratriptan hydrochloride|2.5 mg tablet
16230083|NCT01161654|Drug|naratriptan hydrochoride|2.5 mg tablet
16230084|NCT01161641|Drug|ODSH at 0.125 mg/kg/h|ODSH 1000 mg vials containing 20 cc of normal saline (50 mg/ml) to be prepared for 96-h IV infusion with normal saline based on subject's weight and dose assigned by Study Cohort 1 of 0.125 mg/kg/h.
16230085|NCT01161641|Drug|ODSH at 0.375 mg/kg/h|ODSH 1000 mg vials containing 20 cc of normal saline (50 mg/ml) to be prepared for 96-h IV infusion with normal saline based on subject's weight and dose assigned by Study Cohort 3 of 0.375 mg/kg/h.
16230086|NCT01161641|Drug|ODSH at 0.250 mg/kg/h|ODSH 1000 mg vials containing 20 cc of normal saline (50 mg/ml) to be prepared for 96-h IV infusion with normal saline based on subject's weight and dose assigned by Study Cohort 2 of 0.250 mg/kg/h.
16230087|NCT01161628|Drug|Rituximab|Rituximab 375 mg/m2/dose x 4 weekly doses on days 1, 8, 15 and 22 and then at 3, 6, 9 and 12 months.
16230088|NCT01161615|Drug|MRX-7EAT|Application of up to two patches for up to 7 days.
16230089|NCT01161615|Drug|Placebo|Application of up to two patches for up to 7 days.
16230090|NCT01161602|Drug|Pumosetrag|
16230091|NCT01161602|Drug|Pumosetrag|
16230092|NCT01161602|Other|Placebo|
16230093|NCT01161602|Drug|Pumosetrag|
16230094|NCT01161576|Biological|AAVrh.10CUhCLN2 vector 9.0x10^11 genome copies|The experimental drug for this second generation study has a genome identical to that used in our previous study and delivers the same gene, but instead of an AAV2 capsid (protein shell of the virus), the new vector has the capsid of AAVrh.10, a clade E AAV derived from rhesus macaque (a species of Old World monkeys). The first dose that was given to the first 6 subjects is 9.0x10^11(900,000,000,000 molecules of the drug) genome copies/subject. In regards to drug administrations, we propose to perform 2 series of 6 simultaneous administrations of vector for 75 min each. Each subject will receive the assigned dose of AAVrh.10CUhCLN2, divided among 12 locations delivered through 6 burr holes (2 locations at 2 depths through each hole), 3 burr holes per hemisphere.
16230095|NCT01161576|Biological|AAVrh.10CUhCLN2 vector 2.85x10^11 genome copies|The experimental drug for this 2nd generation study has a genome identical to that used in our previous study and delivers the same gene but instead of an AAV2 capsid (protein shell of the virus), the new vector has the capsid of AAVrh.10, a clade E AAV derived from rhesus macaque (a species of Old World monkeys). Group B will receive a dose of 2.85x10^11 genome copies (285,000,000,000 molecules of the drug). In regards to drug administration, we propose to perform 2 series of 6 simultaneous administrations of vector for 75 min each. Each subject will receive the assigned dose of AAVrh.10CUhCLN2, divided among 12 locations delivered through 6 burr holes, 3 burr holes per hemisphere.
16230096|NCT01161563|Drug|Triptorelin pamoate|Triptorelin pamoate for injectable suspension 22.5 mg administered as a single intramuscular injection in either buttock
16230097|NCT01161563|Drug|Leuprolide acetate|Leuprolide acetate for injectable suspension 45 mg administered as a single subcutaneous injection in the upper- or mid-abdominal area.
16230098|NCT01161550|Drug|Granulocyte colony-stimulating factor (G-CSF)|
16230099|NCT01161550|Drug|Cladribine|
16230100|NCT01161550|Drug|Cytarabine|
16230101|NCT01161550|Drug|All-Trans Retinoic Acid (ATRA)|
16230102|NCT01161550|Drug|Midostaurin|
16230103|NCT01161537|Drug|VX-770|Tablet.
16230104|NCT01161537|Drug|Placebo|Tablet.
16230105|NCT01161524|Drug|Perampanel|2 mg titrated up to 8-12 mg maximum; taken once daily.
16230106|NCT01161524|Drug|Placebo|Matching Placebo taken once daily.
16230107|NCT01161511|Biological|XmAb5574|Intravenous infusion of XmAb5574 administered weekly during two 28-day cycles with an additional dose being administered during the first week of Cycle 1. (Cycle 1 on Days 1, 4, 8, 15, 22; Cycle 2 on Days 1, 8, 15, 22)
16230108|NCT01161498|Biological|Talimogene Laherparepvec|Administered by intratumoral injection
16230109|NCT01161498|Radiation|Radiation|70 grays of radiation administered in 35 fractions over 7 weeks
16230110|NCT01161498|Drug|Cisplatin|Administered by intravenous infusion
16230111|NCT01161485|Behavioral|HIV Testing and Counseling|A manualized individual-level model consisting of two education and counseling sessions that structurally bracket confidential HIV antibody screening.
16230112|NCT01161485|Behavioral|Contingency Management|In voucher-based CM programs, drug users who submit urine samples that are negative for specified drugs are reinforced with vouchers. Based on operant conditioning, CM rewards those who comply with the targeted behavior and does not reward when compliance is not achieved. In this study a mid-value reinforcement CM schedule will be used in order to balance community cost concerns with the need to show comparative efficacy in reducing meth use and concomitant sex risk behaviors in a largely unstudied risk group. Participants in the CM arm will be asked to come to the study site three times a week to leave a urine sample, get the result, and will then be offered a voucher if their urine is clean and given brief verbal feedback.
16230142|NCT01161225|Behavioral|Adult-led asthma self-management program|Control group: The group attended an adult-led day camp where 2 NPs and a MD offered didactic asthma education based on the Power Breathing™ program.
16230143|NCT01161212|Other|Physical education sessions|3(60 minutes each) or 4 (45 minutes each) short sessions of physical education (PE) sessions
16230464|NCT01158820|Drug|Fentanyl demand|12.5 µg demand bolus at discretion of pulmonologist
16230113|NCT01161485|Behavioral|Strengths-based case management|Strengths-based case management (SBCM) is a specific type of case management that is based on the following principles: 1) clients are most successful when they identify and use their strengths, abilities, and assets; 2) goal-setting is guided by the clients' perceptions of their own needs; 3) the client-case manager relationship is promoted as essential; 4) a creative approach to the use of the community will lead to the discovery of needed resources; and 5) case management is conducted in the community. It differs from more traditional case management models that emphasize resource brokerage and client advocacy in its recognition that only the individual can change his/her behavior.
16230114|NCT01161472|Drug|4mg fesoterodine|4mg tablet once daily for 6 days
16230115|NCT01161472|Drug|8mg fesoterodine|4mg tablet once daily for 3 days followed by 8mg tablet once daily for 3 days
16230116|NCT01161472|Drug|alprazolam 1mg|1mg tablet once on last day of treatment period at clinic
16230117|NCT01161472|Drug|Placebo|Placebo tablet for fesoterodine once daily for 6 days and placebo tablet for alprazolam once on last day of treatment period at clinic
16230118|NCT01161459|Drug|Tripterygium wilfordii|Tripterygium wilfordii 120mg/d Prednisone 30mg/d
16230119|NCT01161459|Drug|FK506|capsule
16230120|NCT01161446|Behavioral|Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test|Participants in this arm will be given access to home HIV self-testing kits with the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use with oral fluids. They will be trained to use this device to test themselves for HIV and be able to request up to one self-testing kit per month throughout follow-up.
16230121|NCT01161446|Device|Home HIV self-testing with OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test|The device is the home HIV self-testing kit that includes the OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test for use on oral fluids. The kit itself is not the focus of this trial. As described in the Behavioral Intervention section, the intervention is having access to home self-testing for HIV.
16230122|NCT01161433|Behavioral|Virtually delivered spirometry quality improvement program|"Sites in the intervention arm receive the virtually delivered QI program.
~The program includes:
~Spirometry Fundamentals™ CD-ROM, a computer-based CD-ROM training program that teaches primary care providers and their staff techniques required to perform high-quality spirometry tests, and proper interpretation of spirometric data;
~Case-based, interactive webinars; and
~an Internet-based spirometry quality feedback reporting system."
16230123|NCT01161420|Device|Inspire Upper Airway Stimulation System|Inspire Upper Airway Stimulation System, is a permanent, implantable therapy device, which consists of three implantable components: IPG, stimulation lead, and a sensing lead. In additional the patient receives a remote to activate the therapy.
16230124|NCT01161407|Dietary Supplement|1500 mg/d elemental calcium as calcium carbonate|500 mg elemental calcium as calcium carbonate given 3 times per day with meals for a total of 1500 mg/d elemental calcium. Given for 21 days in conjunction with a controlled diet.
16230125|NCT01161407|Dietary Supplement|Placebo|Placebo for calcium carbonate in same capsule form. Given 3 times per day with meals for 21 days in conjunction with a controlled diet.
16230126|NCT01161394|Drug|Pioglitazone 15mg|
16230127|NCT01161394|Drug|pioglitazone 30mg|
16230128|NCT01161394|Drug|placebo|
16230129|NCT01161381|Device|Estimation of nonlinear indices from Polysomnography|All subjects underwent full night polysomnography. Three nonlinear indices (Largest Lyapunov Exponent, Detrended Fluctuation Analysis and Approximate Entropy) were extracted from three biosignals (airflow from a nasal cannula, thoracic movement and Oxygen saturation) providing input to a data mining application for the creation of predictive models for AHI.
16230130|NCT01161368|Drug|Lapatinib, Vinorelbine|"Lapatinib 1250mg orally once daily continuously
~plus
~Vinorelbine 20 mg/m2 intravenously (IV) once weekly [Days 1 and 8] for 2 weeks, followed by a rest week in a 3-week cycle."
16230131|NCT01161355|Drug|AZD9668|Tablets of AZD9668 and IV dose of [C14]AZD9668
16230132|NCT01161329|Other|High-Intensity Functional Exercise Programmes (HIFE)|Hife include functional exercises consisting of everyday tasks challenging leg strength, postural stability, and gait ability. All exercise shall be performed in weight-bearing positions, eg squats and walking over obstacles. HIFE are performed twice a week during 1 h. for three months in a group with 6-7 seven patients with stroke. Two physiotherapists lead the group and one physiotherapist select exercises for each participant according to their functional deficits. The exercises will be progressively increased in load and difficulty.
16230133|NCT01161316|Drug|mFOLFOX-6 + cetuximab until disease progression or early withdrawal.|"Treatment regimen:
~mFOLFOX-6, day 1, every two weeks; OXALIPLATIN 85 mg/m2; FOLINIC ACID 400 mg/m2; 5-FU 400 mg/m2 IV bolus; 5-FU 2400 mg/m2 continuous infusion for 46 hours
~Cetuximab weekly. Cetuximab 400 mg/m2 the first time the treatment is administered; 250 mg/m2 for subsequent administrations."
16230134|NCT01161316|Drug|8 cycles of mFOLFOX-6 + cetuximab, followed by cetuximab alone until disease progression or early withdrawal.|"Treatment regimen.
~mFOLFOX-6. day 1 every two weeks. OXALIPLATIN 85 mg/m2; FOLINIC ACID 400 mg/m2; 5-FU 400 mg/m2 IV bolus; 5-FU 2400 mg/m2 continuous infusion for 46 hours
~Cetuximab weekly. Cetuximab 400 mg/m2 the first time the treatment is administered; 250 mg/m2 for subsequent administrations."
16230135|NCT01161290|Behavioral|synchronous interactive audio/video telecommunication|4 weekly synchronous interactive audio/video sessions on self-care management for dyspnea provided via the Internet and free downloadable software (Skype) on patients' home computer
16230136|NCT01161277|Drug|Aripiprazole|Dose: 5-10 mg depending on subject weight
16230137|NCT01161277|Drug|Haloperidol|Dose: 1-2 mg depending on subject weight
16230138|NCT01161277|Drug|Placebo sugar pill|Dose: 1-2 pills depending on subject weight
16230139|NCT01161264|Biological|Influenza Vaccine (Surface Antigen, Inactivated) Ph.Eur, Formulation 2010/2011|Single 0.5 mL dose administered into the deltoid muscle of (preferably) the non-dominant arm on Day 1.
16230140|NCT01161238|Other|Monitored for limb volume|Subjects are monitored for limb volume change using bioimpedance analysis
16230141|NCT01161225|Behavioral|Peer-assisted asthma self-management program|Intervention group: An asthma self-management program (Power Breathing™) was implemented by trained peer leaders at an asthma day camp. The program consisted of 3 sessions (appx. 45-60 min/session): basic asthma education (pathophysiology, triggers); psychosocial issues of asthma; and asthma self-management (peak flow monitoring and medication). The program was delivered by trained peer leaders paired for each small group of 6-8 teens. Group activities involved discussion, strategic thinking, knowledge-testing games and role plays.
16230554|NCT01158053|Device|IVUS and FFR|
16230145|NCT01161199|Procedure|Leukapheresis|Blood will be taken by a needle placed in one arm and processed through a machine, which spins the blood so that the white blood cells will be separated out in the machine for purposes of this research and the rest of the blood will be returned through a needle in the other arm.
16230146|NCT01161186|Drug|nab-paclitaxel, gemcitabine, capecitabine|{nab-paclitaxel: Intravenous, 100 to 150 mg/m2 over 30 minutes once per cycle.} {gemcitabine: Intravenous, 750 to 1000 mg/m2 at 10mg/m2/minute once per cycle.} {capecitabine: oral, 500 to 1000 mg/m2 b.i.d. 7 days per cycle}
16230147|NCT01161173|Drug|Erlotinib|Erlotinib was provided in the retail versions of the product.
16230148|NCT01161160|Biological|GSK Biologicals' GSK2340274A (two different formulations)|Intramuscular injection
16230149|NCT01161160|Biological|GSK Biologicals' - GSK2340272A|Intramuscular injection
16230150|NCT01161147|Drug|Meloxicam|Meloxicam Tablets 15 mg
16230151|NCT01161134|Drug|Meloxicam|Meloxicam Tablets 15 mg
16230152|NCT01161121|Drug|adenosine|Measuring FFR and Coronary Flow Reserve after administration of IV adenosine 140 mcg/kg/min for 2 minutes.
16230153|NCT01161121|Drug|regadenoson|Measuring FFR and Coronary Flow Reserve after administration of IV regadenoson 0.4 mg over 10 seconds.
16230154|NCT01161108|Drug|Fast Release Melatonin (FR MLT)|3mg capsules of melatonin will be used. The dose of FR MLT will be 3 mg for children less than or equal to 20 kg, and 6 mg for children greater than 20 kg. The study medication will be given one hour before bedtime, once daily.
16230155|NCT01161108|Drug|Fast Release Placebo|"A matching FR MLT placebo will be compounded by the SickKids research pharmacy.
~The dose of Fast Release Placebo will be 3 mg for children less than or equal to 20 kg, and 6 mg for children greater than 20 kg. The study medication will be given one hour before bedtime, once daily."
16230156|NCT01161108|Drug|Timed Release Melatonin (TR MLT)|"3 mg capsules will be used.
~The dose of TR MLT will be will be 3 mg for children less than or equal to 20 kg, and 6 mg for children greater than 20 kg. The study medication will be given one hour before bedtime, once daily."
16230157|NCT01161108|Drug|Timed Release Placebo|"A matching TR MLT placebo will be compounded by the SickKids research pharmacy.
~The dose of Timed Release Placebo will be will be 3 mg for children less than or equal to 20 kg, and 6 mg for children greater than 20 kg. The study medication will be given one hour before bedtime, once daily."
16230158|NCT01161095|Device|LNG-IUS|Mirena (Bayer)- Levonorgestrel-Intrauterine System
16230159|NCT01161082|Drug|REGN727(SAR236553)|subcutaneous
16230160|NCT01161069|Drug|PF-03049423|PF-03049423 in oral solution, 2.5 mg, given once daily for 14 days; healthy young adult volunteers
16230161|NCT01161069|Drug|PF-03049423|PF-03049423 in oral solution, 7.5 mg, given once daily for 14 days; healthy young adult volunteers
16230162|NCT01161069|Drug|PF-03049423|PF-03049423 in oral solution, 6 mg, given once daily for 7 days, then 12 mg given once daily for 7 days; healthy young adult volunteers
16230163|NCT01161069|Drug|PF-03049423|PF-03049423 in oral solution, 3 mg, given once daily for 7 days, then 6 mg given once daily for 7 days; healthy elderly adult volunteers
16230164|NCT01161069|Drug|PF-03049423|PF-03049423 in oral solution, 5 mg, given once daily for 7 days, then 10 mg given once daily for 7 days; healthy elderly adult volunteers
16230165|NCT01161069|Drug|Placebo|Placebo in oral solution, given once daily for 14 days
16230166|NCT01161043|Device|Sensor wear|All subjects to wear sensors
16230167|NCT01161030|Dietary Supplement|Almonds|
16230168|NCT01161017|Drug|Amitriptyline|Initial dose of 12.5mg will be given for 2 days. Then, daily 25mg will be taken for additional 8 weeks
16230169|NCT01161017|Drug|Topiramate|For the first 5 days of treatment 25mg is prescribed and should be ingested in one evening dose. For another 5 days, 25g dose should be taken twice a day (morning and evening). For the next 5 days, morning dose will be 25mg; evening dose will be 50mg. For the remaining 6 weeks of treatment, a dose of 50mg twice a day will be advised
16230170|NCT01161004|Drug|Sugammadex - Nacl 9/00|"Sugammadex: 4 mg/kg when post tetanic count shows at least 1 or 2 responses; 2 mg/kg when Train of four shows at least 2 responses.
~Nacl 9/00: same volume as Sugammadex"
16230171|NCT01161004|Drug|Nacl 9/00 - sugammadex|"Nacl 9/00: same volume as Sugammadex
~Sugammadex: 4 mg/kg when post tetanic count shows at least 1 or 2 responses; 2 mg/kg when Train of four shows at least 2 responses."
16230172|NCT01160991|Procedure|Glucose clamp technique|euglycemic hyperinsulinemic clamp with target blood glucose of 90 mg/dl (5 mmol/l), followed by hyperglycemic clamp, target blood glucose of 180 mg/dl (10 mmol/l) for measurement of insulin sensitivity and insulin secretion
16230173|NCT01160991|Drug|Amisulpride|Single dose of amisulpride 200 mg p.o. given at 8:00 a.m.
16230174|NCT01160991|Drug|Olanzapine|Single dose of olanzapine 10 mg p.o. given at 8:00 a.m.
16230175|NCT01160991|Drug|Placebo|Placebo capsules are given at 8:00 a.m.
16230176|NCT01160978|Drug|Simvastatin 80mg|The transplant recipients who have received an organ from donors treated with simvastatin 80 mg.
16230177|NCT01160978|Drug|Control Rx|The transplant recipients who have received an organ from non-treated donors.
16230178|NCT01160965|Drug|0.5% levobupivacaine|15mls of a 5mg/ml solution of the local anaesthetic levobupivacaine given via the epidural catheter.
16230179|NCT01160965|Drug|0.75% Ropivacaine|15mls of a 7.5mg/ml solution of the local anaesthetic ropivacaine given via the epidural catheter.
16230180|NCT01160952|Drug|itraconazole|the two groups are defined by different treatment duration
16230181|NCT01160939|Other|low intensity exercise|exercise protocol with six stages of exercise (1. upper limbs, 2. inferiors, 3. walk 35 m, 4. ½ flight of stairs, 5. walk 200 m 6. a flight of stairs) with intensity between 2-6 metabolic equivalents
16230182|NCT01160926|Drug|AZD6244|"Dose finding trial AZD6244 cohort 1 - 50mg bd AZD6244 cohort 2 - 75mg bd
~Capsule form, given for 10 days as single agent then for 35 days in combination with standard chemoradiotherapy"
16230183|NCT01160926|Drug|Cediranib (AZD2171)|"10 days single agent dosing with Cediranib then 35 days in combination with standard chemoradiotherapy AZD2171 cohort 1 - 15mg od AZD2171 cohort 2 - 20mg od AZD2171 cohort 3 - 30mg od
~Oral tablets"
16230184|NCT01160913|Procedure|Continuous wound infusion|
16230185|NCT01160913|Procedure|Continuous wound|
16230186|NCT01160900|Procedure|Coronary angioplasty all lesions|treatment by coronary angioplasty and drug eluting stent of all lesions, adjunctive use of prasugrel and bivalirudin
16230187|NCT01160874|Other|Polysomnography|Sleep study monitoring
16230189|NCT01160874|Behavioral|Neuropsychological evaluation|Neuropsychological evaluation for cognitive functions study
16230190|NCT01160874|Other|Driving test on a simulator|Driving simulator test during wich a camera register different parameters as the position of the vehicle.
16230191|NCT01160861|Drug|MEMP1972A|Repeating ascending dose
16230192|NCT01160861|Drug|placebo|Repeating ascending dose
16230193|NCT01160848|Drug|Area cleaned with saline water and occluded with Tegaderm|
16230194|NCT01160848|Drug|Area cleaned with saline water|
16230195|NCT01160848|Drug|Area cleaned with Ethyl alcohol solution|
16230196|NCT01160848|Drug|Visonac left on the skin for 24 hours in facial area one|
16230197|NCT01160848|Drug|Visonac wiped off after one hour|
16230198|NCT01160848|Drug|Visonac left on the skin 24 hours in facial area two|
16230199|NCT01160835|Procedure|total knee arthroplastyinstruments|Quadriceps-sparing arthrotomy with side-cutting instruments
16230200|NCT01160822|Biological|Canakinumab|Intra-articular injection
16230201|NCT01160822|Drug|Placebo to canakinumab|Intra-articular injection
16230202|NCT01160822|Drug|Naproxen|Tablets for oral administration
16230203|NCT01160822|Drug|Placebo to Naproxen|Tablets for oral administration
16230204|NCT01160809|Other|Mosquito repellent|Mosquito repellent (Buzz Off jelly) every evening applied to face, neck, hands and legs
16230205|NCT01160796|Drug|placebo|1x14-day course of treatment during 4 cycles
16230206|NCT01160796|Drug|Lcr35®|1x14-day course of treatment during 4 cycles
16230207|NCT01160770|Drug|Clobazam|Clobazam will be provided in 5 mg, 10 mg and 20 mg tablets and will be dispensed in bottles as needed at each visit. Bottles may be dispensed between visits if necessary. Subjects will start at a common dose level of 0.5 mg/kg, not to exceed 40 mg/day, and must maintain the dose level for 48 hours. After the first 48 hours of the treatment period, investigators will be able to increase, decrease or maintain the subject's dose, up to an approximate maximum daily dose of 2.0 mg/kg (maximum dose of 80 mg/day).
16230208|NCT01160757|Device|ultrasound|ultrasound exposure on acute acne lesions
16230209|NCT01160744|Biological|IMC-1121B (ramucirumab)|10 milligrams/kilogram (mg/kg) once every 3 weeks beginning Day 1, Cycle 1
16230210|NCT01160744|Drug|Pemetrexed|500 milligrams/square meter (mg/m²) on Day 1 of every 21-day cycle
16230211|NCT01160744|Drug|Carboplatin (AUC 6)|Day 1 of every 21-day cycle
16230212|NCT01160744|Drug|Cisplatin|75 mg/m² intravenous (IV) on Day 1 of each 21-day cycle
16230213|NCT01160744|Drug|Gemcitabine|1000 mg/m² on Days 1 and 8 of every 21-day cycle
16230214|NCT01160744|Drug|Carboplatin (AUC 5)|Day 1 of every 21-day cycle
16230215|NCT01160731|Drug|cisplatin|
16230216|NCT01160731|Drug|etoposide phosphate|
16230217|NCT01160731|Drug|panobinostat|
16230218|NCT01160731|Other|laboratory biomarker analysis|
16230219|NCT01160731|Other|pharmacological study|
16230220|NCT01160718|Drug|fulvestrant|Arm A: Fulvestrant 500mg i.m. day 1, 15, day 1 of cycle 2, then every 28 +/- 3 days Arm B: Fulvestrant 500mg i.m. day 1, 15, day 1 of cycle 2, then every 28 +/- 3 days
16230221|NCT01160718|Drug|selumetinib|AZD6244 75 mg p.o. bid
16230222|NCT01160705|Drug|docetaxel|
16230223|NCT01160705|Genetic|RNA analysis|
16230224|NCT01160705|Genetic|reverse transcriptase-polymerase chain reaction|
16230225|NCT01160705|Other|circulating tumor cell analysis|
16230226|NCT01160705|Other|laboratory biomarker analysis|
16230227|NCT01160692|Dietary Supplement|Multivitamin/Multimineral/Ginkgo (BAY 81-2775)|Multivitamin/Multimineral/Ginkgo (BAY 81-2775), daily oral intake of film coated tablets for 3 months
16230228|NCT01160692|Other|Placebo|Daily oral intake of matching placebo tablets for 3 months
16230229|NCT01160666|Drug|Belimumab|Belimumab will be administered at 10 mg/kg at Days 0, 14, 28 and then every 28 days until week 24 for all patients and week 48 for those considered responders at week 28.
16230230|NCT01160653|Device|FES-IM|implantable Functional Electrical Stimulation
16230231|NCT01160653|Other|Cognitive training|training of impaired cognitive processes
16230232|NCT01160640|Drug|Ceftriaxone|ceftrixone 250mg IM single dose
16230233|NCT01160640|Drug|Doxycycline|Doxycycline 100 mg PO bid x 14 days
16230234|NCT01160640|Drug|Metronidazole|metronidazole 500 mg PO bid x 14 days
16230235|NCT01160640|Drug|Placebo Oral Capsule|placebo oral capsule PO bid x 14 days
16230236|NCT01160627|Other|Hydration|Saline hydration
16230237|NCT01160627|Drug|Acetylcysteine|Acetylcystein tablets for 2 days
16230238|NCT01160627|Drug|Sodium bicarbonate|Sodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours
16230239|NCT01160627|Drug|Combined Acetylcystein and Sodium Bicarbonate|Sodium bicarbonate 500 ml followed by 100 ml/hour for 5 hours combined with acetylcystein tablets for 2 days
16230240|NCT01160614|Drug|Oxycodone hydrochloride controlled-release (ORF) tablets|Oxycodone hydrochloride controlled-release (ORF) tablets (10 mg, 15 mg or 20 mg) taken every 12 hours
16230241|NCT01160601|Drug|Paclitaxel / Carboplatin|Patients will receive commercially available paclitaxel (200 mg/m2) and carboplatin (target area under the concentration-time curve [AUC] 6) on Day 1 of each 21 day cycle for up to 6 cycles.
16230242|NCT01160601|Drug|bavituximab|Patients will receive 3 mg/kg bavituximab, administered weekly until progression or toxicity.
16230243|NCT01160588|Drug|Sertraline|Oral sertraline will be started at 25 mg/day, increasing on subsequent visits to 50, 75, 100, 125, 150, and 200mg/day) Unless adverse effects become problematic, the goal is for subjects to reach 200mg/day. Dosing of sertraline is flexible, based on tolerance (absence of side effects) and clinical response.
16230244|NCT01160484|Drug|DVD-R|40 mg dexamethasone will be administered IV on Days 1, 4, 8, and 11 of each cycle. 1.0 mg/m2 Bortezomib will be administered IV over 3 to 5 seconds followed by a standard saline flush, on Days 1, 4, 8, and 11 immediately following the dexamethasone infusion. 4.0 mg/m2 PLD will be given as a 90 minute infusion on Day 1 of Cycle 1 and subsequent doses may be administered over 30 to 60 minutes on Days 4, 8 and 11 of Cycle 1 and on Days 1, 4, 8, and 11 of each subsequent cycle, following the bortezomib administration. 10 mg/day lenalidomide will be administered PO on days 1-14 of a 28-day treatment cycle, followed by a 14-day rest period, following the PLD administration.
16230461|NCT01158820|Drug|Dexmedetomidine maintenance|0.5 µg/kg/hour for the duration of bronchoscopy (58.5 minutes average)
16230245|NCT01160458|Drug|IMC-A12|20 mg/kg intravenous over 60 minutes or not to exceed 25 mg/minute once every 3 weeks (+ or -1 day cycle 3 and beyond)
16230246|NCT01160445|Drug|Zanolimumab|14 mg/kg as an intravenous infusion weekly (+/- 3 days) for 9 weeks.
16230247|NCT01160445|Drug|Aldesleukin|720,000 IU/kg every 8 hours for a maximum of 15 doses.
16230248|NCT01160432|Drug|Methadone, naloxone|Methadone 2 mg/ml in combination with naloxone 0,04 mg/ml daily according to patient's individual dose. At first open label pilot using single (individual) dosage for 2 patients. After that crossover study using methadone 2 mg/ml in combination with naloxone 0,04 mg/ml compared to methadone 2 mg/ml alone in one week's periods for four weeks.
16230249|NCT01160419|Drug|Docetaxel 50 mg/m2, 1-hour-Infusion, day 1|50 mg/m2, 1-hour-Infusion, day 1
16230250|NCT01160419|Drug|Oxaliplatin 85 mg/m², 2-hour-Infusion, day 1|85 mg/m², 2-hour-Infusion, day 1
16230251|NCT01160419|Drug|Folinic acid 200 mg/m², 1-2-hour-Infusion, day 1|200 mg/m², 1-2-hour-Infusion, day 1
16230252|NCT01160419|Drug|5-FU 2600 mg/m², 24-hour-Infusion, day 1|2600 mg/m², 24-hour-Infusion, day 1
16230253|NCT01160393|Device|Miniaturized bypass system|Compare the conventional bypass system and miniaturized bypass system of the incidence of atrial fibrillation after cardiac surgery
16230254|NCT01160380|Drug|armodafinil|Armodafinil taken at 150 mg daily. Taken as three 50 mg tablets.
16230255|NCT01160380|Drug|Placebo|Placebo taken at 150 mg daily. Taken orally as three 50 mg tablets.
16230256|NCT01160367|Other|TAILORED Patient Family Decision Making|Patient-family dyads will receive TAILORED intervention on health decision making
16230257|NCT01160367|Other|standard of care|Patient-family dyads will receive standard of care in health decision-making
16230258|NCT01160354|Drug|Plerixafor|Starting at 240 mcg/kg daily subcutaneous (SQ) injection on Days 1-5, 4-6 hours before a 1 hour (+/- 30 minutes) IV administration of Clofarabine
16230259|NCT01160354|Drug|Clofarabine|Fixed dose of 30 mg/m2/day during Induction cycle (20 mg/m2/day in consolidation cycles).
16230260|NCT01160341|Drug|Testosteron|Testosteron 250mg injection per 3-4 weeks for 6 months
16230261|NCT01160328|Drug|Leuprolide|7.5 mg - 1 month depot, 2 doses over 7 weeks
16230262|NCT01160328|Drug|Testosterone|7.5g - 1% testosterone gel, daily x 7 weeks
16230263|NCT01160315|Drug|Triptorelin|Triptorelin: intramusculAR injection every 3 months
16230264|NCT01160315|Drug|Norethisterone acetate|5 mg/day per os until during chemotherapy
16230265|NCT01160302|Drug|Microgranular Curcumin C3 Complex®|4 grams twice daily for 21-28 days
16230266|NCT01160289|Drug|LY2452473|Administered orally, once daily for 12 weeks
16230267|NCT01160289|Drug|tadalafil|Administered orally, once daily for 12 weeks
16230268|NCT01160289|Drug|placebo (tadalafil)|Administered orally, once daily for 12 weeks
16230269|NCT01160289|Drug|placebo (LY2452473)|Administered orally, once daily for 12 weeks
16230270|NCT01160276|Drug|cyclosporine+colchicine|the 14 patients of the 1st group are under cyclosporine and One pill of colchimax 1mg will be taken by all the patients at Day 3.
16230271|NCT01160276|Drug|tacrolimus|the 14 patients of the second group are under tacrolimus and One pill of colchimax 1mg will be taken by all the patients at Day 3.
16230272|NCT01160263|Drug|SPECT : 123 I-FP-CIT (DATSCAN) and 123I-ADAM|"123 I-FP-CIT (DATSCAN) : 185 MBq (5 mCi), 2,5 ml will be injected via an arm intravenous catheter.
~123I-ADAM:185 MBq,5 ml will be injected via an arm intravenous catheter."
16230273|NCT01160250|Drug|vismodegib (GDC-0449)|Oral repeating dose
16230274|NCT01160237|Biological|PandemrixTM|One dose intramuscular injection
16230275|NCT01160237|Biological|FluarixTM/ Influsplit SSW® 2010/2011|One dose intramuscular injection
16230276|NCT01160224|Drug|GW766944|Drug: GW766944 (Active Drug Treatment)
16230277|NCT01160224|Other|Placebo|This is placebo to match.
16230278|NCT01160211|Drug|lapatinib|1000 mg by mouth once a day
16230279|NCT01160211|Drug|trastuzumab|Loading dose of 8 mg/kg IV followed by the maintenance dose of 6 mg/kg IV every 3 weeks
16230280|NCT01160211|Drug|Aromatase inhibitor|Aromatase inhibitor (either letrozole, anastrozole, or exemestane) of investigator's choice given by mouth once daily
16230281|NCT01160211|Drug|lapatinib|1500 mg by mouth once daily
16230282|NCT01160198|Drug|ferrous ascorbate|100 mg elemental iron
16230283|NCT01160198|Dietary Supplement|ferrous bisglycinate chelate 1 OD|60 mg elemental iron
16230284|NCT01160198|Dietary Supplement|ferrous bisglycinate chelate 2 OD|120 mg elemental iron
16230285|NCT01160185|Drug|paclitaxel|paclitacel
16230286|NCT01160185|Drug|cisplatin|cisplatin monotherapy
16230287|NCT01160185|Drug|topotecan|topotecan
16230288|NCT01160172|Biological|Staphylococcal investigational vaccine GSK2392103A|intramuscular vaccination according to protocol schedule
16230289|NCT01160172|Biological|Staphylococcal investigational vaccine GSK2392105A|intramuscular vaccination according to protocol schedule
16230290|NCT01160172|Biological|Staphylococcal investigational vaccine GSK2392106A|intramuscular vaccination according to protocol schedule
16230291|NCT01160172|Biological|Staphylococcal investigational vaccine GSK2392019A|intramuscular vaccination according to protocol schedule
16230292|NCT01160172|Drug|Saline placebo|intramuscular vaccination according to protocol schedule
16230293|NCT01160159|Other|Tests|Arterial parameters
16230294|NCT01160159|Other|Healthy volunteers|Arterial parameters and blood test
16230295|NCT01160133|Other|Systane|Systane Lubricant Eye Drops (1-2 drops in each eye, four times per day)
16230296|NCT01160133|Other|Refresh Tears|Refresh Tears Lubricant Eye Drops (1-2 drops in each eye, four times per day)
16230297|NCT01160120|Drug|generic FDC of TDF/3TC/EFV|Patients who were on individual TDF 3TC and EFV regimen before baseline will undergo TDM at baseline. Therapeutic drug monitoring (TDM) of generic FDC of TDF/3TC/EFV will be done after 4 weeks, to ensure steady state. At baseline and week 4 safety data will be obtained. In order to assess the efficacy and the long term safety of this drug, at week 12, 24 and 48 viral load, CD4 and safety parameters will be obtained.
16230425|NCT01159093|Behavioral|Clinician Decision Support|Clinician-focused intervention includes an electronic health record-based decision support mechanism including reminders, education, audit and feedback on vaccination success.
16230462|NCT01158820|Drug|Ketamine maintenance|8 µg/kg/min for the duration of bronchoscopy (58.5 minutes average)
16230298|NCT01160107|Drug|RP followed by MPR|Induction (4 cycles):Lenalidomide 25 mg/die for 21 days followed by a 7 days rest period and Prednisone at 50 mg three times a week continuously . Consolidation (6 cycles): Melphalan 2 mg three times a week, Prednisone 50 mg three times a week, and Lenalidomide 15 mg/die for 21 days followed by a 7 days rest period. According to the results of the first stage the decisions are as follows: 1. Starting a second stage, at the same dose of lenalidomide for MPR cycles, if grade 3-4 adverse events are 25-50% and PR > 50%; 2. The study stop (if PR <40% and grade 3-4 adverse events >25-30%) 3. A new first stage may be started: - Lenalidomide 20 mg/die if grade 3-4 adverse events are < 25-30%, independently from efficacy; - Lenalidomide 10 mg/die if grade 3-4 adverse events are > 50% and PR rate > 50%. Maintenance: Lenalidomide 10 mg/day from day 1 to 21, followed by a 7-day rest period and Prednisone 25 mg three times a week.Each cycle will be repeated every 28 days, until PD.
16230299|NCT01160094|Drug|Treatment|patients treated with Lapatinib-Capecitabine after Trastuzumab Progression
16230300|NCT01160081|Other|Serum sample|Serum samples collected
16230301|NCT01160068|Drug|Metformin|Metformin Tablets 1000 mg
16230302|NCT01160068|Drug|Glucophage|Glucophage 1000 mg tablets of Bristol-Myers Squibb
16230303|NCT01160055|Procedure|Middle ear fluid and urine.|Middle ear fluid and urine collection.
16230304|NCT01160042|Drug|Metformin|Metformin Tablets 1000 mg
16230305|NCT01160042|Drug|Glucophage|Glucophage 1000 mg tablets of Bristol-Myers Squibb
16230306|NCT01160029|Drug|Nateglinide|Nateglinide Tablets 120 mg
16230307|NCT01160003|Drug|GW870086X|5mg and 8.75mg GW870086X once daily for 14 days in separate traetment periods.
16230308|NCT01160003|Drug|Placebo|placebo will be randomly inserted into one of the treatment periods following the treatment sequences outlined in the protocol.
16230309|NCT01159990|Biological|rAd5 Gag-Pol Env A/B/C|1×10^10 particle units (PU) rAd5 Gag-Pol, Env A/B/C (3:1:1:1 mixture) delivered via intramuscular injection
16230310|NCT01159990|Biological|rAd5 Gag-Pol|5×10^9 PU rAd5 Gag-Pol delivered via intramuscular injection
16230311|NCT01159977|Behavioral|Facilitated small groups|1 hour sessions every 2 weeks for small groups of 9 participants, 19 sessions over 9 months.
16230312|NCT01159977|Behavioral|Unstructured time.|1 protected hour every 2 weeks for 9 months, without small group structure.
16230313|NCT01159977|Behavioral|Usual practice|No protected time provided.
16230314|NCT01159964|Biological|Immunotherapeutic GSK2302032A, different formulations|Intramuscular administration
16230315|NCT01159951|Other|Epidemiologic Surveillance System of the Ministry of Health of Panama|Systematic review of the databases of epidemiologic surveillance system, Ministry of health, Panama
16230316|NCT01159938|Drug|Lispro|Dosage based on participants with type 2 diabetes mellitus (T2DM) normal morning insulin dose and energy content of participant's normal breakfast. Subcutaneous injection given on one occasion. Administered once on low post prandial day.
16230317|NCT01159925|Procedure|Serum sample|Serum samples collected
16230318|NCT01159912|Drug|Fluticasone propionate|Fluticasone propionate inhalation powder, 250 µg
16230319|NCT01159912|Drug|Fluticasone furoate|Fluticasone furoate inhalation powder, 100 µg
16230320|NCT01159912|Drug|Placebo|Placebo inhalation powder
16230321|NCT01159899|Procedure|Transplantation of Bone Marrow Stem Cells Activated in Knee Arthrosis|Transplantation of Activated Bone Marrow Stem Cells in Knee Arthrosis, under arthroscopy, in one-step procedure
16230322|NCT01159886|Procedure|Ileal intubation|"After confirmation of cecal intubation, patient will undergo randomization to either the left-lateral decubitus or supine position. Then terminal ileal intubation will be attempted. Partial suction and scope manoeuvres for ileal intubation will be allowed.
~Use of anti-peristalsis agents, use of biopsy forceps, as a guidewire or an ''anchor'' to facilitate the IC- valve intubation, and intubation in the retroflexed position will not be allowed."
16230323|NCT01159873|Drug|CEP-37251|up to 5 subcutaneous (sc) doses (given sequentially in cohort groups) of CEP-37251 (0.03, 0.1, 0.3, 1.0, and 3.0 mg/kg) will be studied. After all 5 sc doses have been studied, an intravenous (iv) dose of 0.3 mg/kg will be studied.
16230324|NCT01159873|Drug|Placebo|up to 5 subcutaneous (sc) doses (given sequentially in cohort groups) of Placebo (0.03, 0.1, 0.3, 1.0, and 3.0 mg/kg) will be studied. After all 5 sc doses have been studied, an intravenous (iv) placebo dose of 0.3 mg/kg will be studied.
16230325|NCT01159860|Procedure|cryosurgery|freezing of lesion with liquid nitrogen
16230326|NCT01159860|Procedure|Curettage|the lesion will be anesthetized and destroyed with a curette.
16230327|NCT01159847|Drug|sitagliptin|sitagliptin tablet,100 mg p.o. qd,2 year
16230328|NCT01159847|Drug|Insulin|
16230329|NCT01159821|Drug|31001074/paroxetine|1 tablet of 31001074 will be administered on Day 1 and Day 13. One 20-mg paroxetine tablet will be administered once daily from Days 4 through 15
16230330|NCT01159808|Drug|INX-08189|3, 25 and 100 mg capsules; oral administration, single dose
16230331|NCT01159808|Drug|Placebo|matching placebo capsules, oral administration, single dose
16230332|NCT01159782|Other|Rhinovirus infection|All subjects (asthmatic and non asthmatic healthy)will be infected with Rhinovirus 16.
16230333|NCT01159769|Drug|Olopatadine hydrochloride ophthalmic solution, 0.2% (Pataday®)|Commercially marketed ophthalmic solution for the treatment of ocular itching associated with allergic conjunctivitis
16230334|NCT01159756|Drug|Travacom|Travacom ophthalmic solution (1 drop per day)
16230335|NCT01159730|Drug|VB-201 or Placebo|
16230336|NCT01159704|Behavioral|Peer Education Model|The peer education intervention will be delivered by trained outreach workers in a group format with 8-10 indexes over five sessions spanning three weeks. The sessions will focus on knowledge of HIV transmission, self-efficacy and skills-building regarding HIV risk reduction, with an emphasis on the dissemination of such information and skills to network members.
16230337|NCT01159704|Behavioral|HIV Counseling and Education Model|"The C & E intervention is a manualized individual-level model consisting of two education and counseling sessions that structurally bracket confidential HIV antibody screening."
16230426|NCT01159093|Other|Family Decision Support and Clinician Decision Support|This will be a combination of the family-focused decision support (telephone reminder calls) and clinician-focused decision support (clinical alerts).
16230427|NCT01159093|Other|Control|Usual care
16230463|NCT01158820|Drug|Midazolam demand|0.5 mg demand bolus at discretion of pulmonologist
16230338|NCT01159678|Behavioral|online psychoeducation|"The online psychoeducation contains 12 modules which will be administered once per week over the course of three months. The content of each module is as follows:
~Important of sexuality to quality of life. & Definitions of sexual desire and arousal.
~Consideration of the predisposing, precipitating, and perpetuating factors in his/her sexual difficulties.
~Sexual beliefs.
~Mindfulness.
~Genital anatomy and physiology.
~Body Image.
~Relationship satisfaction and communication.
~Body-oriented mindfulness exercises (focusing and self-observation).
~Using Thought records.
~Mindfulness and the thought stream.
~Sexual aids to boost arousal.
~Moving on.
~In addition to these weekly modules, all participants will have access to a moderated and password-protected bulletin board to which participants can post questions and the PI will respond."
16230339|NCT01159665|Drug|ocriplasmin|125µg ocriplasmin intravitreal injection
16230340|NCT01159665|Drug|ocriplasmin|125µg ocriplasmin intravitreal injection
16230341|NCT01159665|Drug|ocriplasmin|125µg ocriplasmin intravitreal injection
16230342|NCT01159665|Drug|ocriplasmin|125µg ocriplasmin intravitreal injection
16230343|NCT01159665|Drug|ocriplasmin|125µg ocriplasmin intravitreal injection
16230344|NCT01159652|Drug|zaleplon|10 mg
16230345|NCT01159652|Drug|zolpidem extended release|12.5 mg
16230346|NCT01159652|Drug|bedtime placebo|placebo
16230347|NCT01159652|Drug|middle of the night placebo|placebo
16230348|NCT01159639|Drug|Clopidogrel|patients with inappropriate response to aspirin 300 mg after CABG, assessed by multiple electrode aggregometry are randomized to receive clopidogrel 75 mg daily dose
16230349|NCT01159626|Drug|PF-03463275|Oral single 20 mg dose as two 10mg controlled release tablets
16230350|NCT01159626|Drug|PF-03463275|Oral single 40 mg dose as four 10mg controlled release tablets
16230351|NCT01159626|Drug|PF-03463275|Oral single 60 mg dose as six 10mg controlled release tablets
16230352|NCT01159626|Drug|Placebo|Oral single dose as matching placebo
16230353|NCT01159626|Drug|PF-03463275|Oral multiple 40 mg doses as four 10mg controlled release tablets for 7 days
16230354|NCT01159626|Drug|Placebo|Oral multiple doses as matching placebo for 7 days
16230355|NCT01159613|Other|Responders|Responders
16230356|NCT01159613|Other|Non Responders|Non Responders
16230357|NCT01159600|Drug|Placebo identical to BI 10773 high dose|Placebo tablets matching BI 10773 high dose
16230358|NCT01159600|Drug|Placebo identical to BI 10773 low dose|Placebo tablets matching BI 10773 low dose
16230359|NCT01159600|Drug|BI 10773|BI 10773 tablets once daily high dose open label
16230360|NCT01159600|Drug|BI 10773|BI 10773 tablets once daily high dose
16230361|NCT01159600|Drug|Placebo identical to BI 10773 low dose|Placebo tablets matching BI 10773 low dose
16230362|NCT01159600|Drug|BI 10773|BI 10773 tablets once daily low dose
16230363|NCT01159600|Drug|Placebo identical to BI 10773 high dose|Placebo tablets matching BI 10773 high dose
16230364|NCT01159587|Drug|Recombinant Factor VIII (Kogenate FS, BAY14-2222)|Long-term secondary prophylaxis with product administered 20-30 UI /kg three times weekly
16230365|NCT01159587|Drug|Recombinant Factor VIII (Kogenate FS, BAY14-2222)|On-demand treatment with product given only for bleeding episodes
16230366|NCT01159574|Drug|dexamethasone|40mg will be given on days 1, 8, 15, 22 of a 28-day cycle
16230367|NCT01159574|Drug|clarithromycin|orally at a dose of 500 mg twice a day on days 1-28 of a 28 day cycle
16230368|NCT01159574|Drug|Pomalidomide|orally 4mg daily for days 1-21 of each 28 day cycle
16230369|NCT01159561|Biological|Western Equine Encephalitis Vaccine|Subject will be vaccinated with 0.5 mL of reconstituted WEE vaccine, inactivated, TSI-GSD 210 (Lot 3-1-92) subcutaneously in the upper outer aspect of the deltoid region.
16230370|NCT01159548|Drug|Promethazine|
16230371|NCT01159548|Drug|Promethazine|
16230372|NCT01159535|Behavioral|Mindfulness Based Relapse Prevention|The MBRP intervention comprises 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists (Bowen, et al., 2009). In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component.Group sessions include discussions of mindfulness as a means of coping with craving and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice, and homework assignments.
16230373|NCT01159535|Behavioral|Relapse Prevention|intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants)
16230374|NCT01159535|Behavioral|Treatment as Usual|All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis.
16230375|NCT01159522|Drug|SCB01A|This is an open-label, single-arm, dose-escalation, safety and tolerability study. Eligible subjects will be assigned to a SCB01A dose level at the time of study entry and scheduled to receive two treatment cycles with SCB01A for the observation of DLT. A treatment cycle is defined as a three-hour infusion of SCB01A given every 21 days. Unless any off-study criteria are met, the study period of each subject can be up to two cycles.
16230376|NCT01159509|Behavioral|sodium taste tests|The cohort group will had sodium taste tests and an interview regarding diat habits.
16230377|NCT01159496|Drug|PF-05212377 (SAM-760)|Oral capsule, once daily for 14 days 1.5 mg, 5 mg, 15 mg, 30 mg and 50 mg
16230378|NCT01159496|Drug|Placebo|Oral capsule, once daily for 14 days
16230379|NCT01159483|Drug|PF-04958242|Administered as specified in the treatment arm
16230380|NCT01159483|Drug|Placebo|Administered as specified in the treatment arm
16230381|NCT01159457|Biological|Hepatitis B vaccination (Sci-B-Vac)|A dose of 5mcg (0.5 ml) (up to 10yr old) and 10mcg (1.0 ml)(above 10yr old) of the recombinant HBV vaccine will be administered intramuscularly at zero, one and six months intervals
16230382|NCT01159457|Biological|Hepatitis B vaccination (EngerixB)|A dose of 10mcg (0.5 ml) of the recombinant HBV vaccine will be administered intramuscularly at zero, one and six months intervals
16230383|NCT01159431|Device|Trigeminal Nerve Stimulation|External stimulation of the supraorbital branch of the Trigeminal Nerve using a digital TENs unit
16230428|NCT01159080|Drug|routine dose tacrolimus and less myfortic|oral regular dose of tacrolimus + less dose of myfortic trough level of tacrolimus will be 5-10 ng/mL and oral myfortic dose will be 180-360 mg twice a day
16230384|NCT01159418|Drug|Panobinostat (LBH589), Carboplatin and Paclitaxel|"Panobinostat (LBH589) p.o. on days 1,4,8 and 11 of each cycle (20mg-45mg).Carboplatin i.v.on day 1 at a total dose corresponding to a AUC of 5 µg/ml.h. Paclitaxel as 3 hour infusion on day 1 (135 mg/m2).
~Panobinostat (LBH589) p.o. on days 1, 4, 15 and 18 of each cycle (20mg-30mg).Carboplatin i.v. on day 8 at a total dose corresponding to a AUC of 5 µg/ml.h.Paclitaxel as a 3 hour infusion on day 8 (135mg/m2-175mg/m2).
~Once the MTD is achieved:Panobinostat (LBH589) p.o. on days 1 and 4 of each cycle(20mg-30 mg). Carboplatin i.v. on day 8 at a total dose corresponding to a AUC of 5 µg/ml.h.Paclitaxel as a 3 hour infusion on day 8 (135mg/m2-175 mg/m2).
~The treatment will be repeated every three weeks until disease progression."
16230385|NCT01159405|Radiation|Radiolabeled (99mTc) GP (Glycopeptide)|one injection of Technetium Glycopeptide to yield a target activity of 20-25 mCi to be given by slow IV push (over 3-5 minutes) 5 mg, 10 mg & 20 mg of GP will be injected
16230386|NCT01159379|Drug|ertapenem|intravenous, 1 gram, once
16230387|NCT01159366|Procedure|percutaneous coronary intervention|early timing
16230388|NCT01159353|Drug|Insulin glulisine|Insulin glulisine 100 U/ml, solution for injection in vial Dose: 0.2 U/Kg Administration: single subcutaneous injection with syringe in the periumbilical abdomen within 2 minutes before the standard meal
16230389|NCT01159353|Drug|Insulin aspart|Insulin aspart: 100 U/mL, solution for injection in vial Dose: 0.2 U/Kg Administration: single subcutaneous injection with syringe in the periumbilical abdomen within 2 minutes before the standard meal
16230390|NCT01159327|Drug|Sorafenib|Sorafenib 400mg, bid(800mg/day), daily, PO
16230391|NCT01159314|Procedure|Baerveldt Device surgical Procedure|Implant surgery
16230392|NCT01159301|Drug|entinostat|Given orally (PO)
16230393|NCT01159301|Drug|sorafenib tosylate|Given PO
16230394|NCT01159301|Other|pharmacological study|Correlative studies
16230395|NCT01159301|Other|laboratory biomarker analysis|Correlative studies
16230396|NCT01159288|Biological|Dex2|"Metronomic dosage of Cyclophosphamide during 3 weeks (50mg/day orally) as reported 15, before specific treatment.
~Induction immunotherapyIntradermal injections of Dex once a week during 4 consecutive weeks.(Peptides pulsed onto DC, sources of Dex: PRS pan-DR, MAGE-3 DP04, MAGE-1 A2, MAGE-3 A2, NY-ESO-1 A2 et MART-1 A2)
~Continuation Immunotherapy: Intradermal injections of Dex every two weeks during 6 weeks."
16230397|NCT01159275|Drug|Generic LPV/r and Aluvia (pharmacokinetics)|Generic LPV/r 200/50 mg BID 12 hr PK then cross over to Pediatric Aluvia 200/50 mg BID
16230398|NCT01159275|Drug|Aluvia and Generic LPV/r (pharmacokinetics)|First Pediatric Aluvia® 200/50 mg BID, then cross over to Generic LPV/r 200/50 mg BID
16230399|NCT01159262|Drug|Midazolam|Per package insert, N-PASS (Neonatal Pain, Agitation, and Sedation Scale) scores and investigator discretion
16230400|NCT01159262|Drug|Fentanyl/Morphine|Per package insert, N-PASS scores and investigator discretion.
16230401|NCT01159262|Drug|Dexmedetomidine|
16230402|NCT01159249|Drug|Vildagliptin|
16230403|NCT01159236|Drug|Paclitaxel|80 mg/m2 by vein over about 1-2 hours once every 7 days x 12 courses.
16230404|NCT01159236|Drug|Fluorouracil|500 mg/m2 for 4 courses (once every 7 days)
16230405|NCT01159236|Drug|Doxorubicin|50 mg/m2 by vein given on day 1 and repeated once every 21 days for 4 treatments
16230406|NCT01159236|Drug|Epirubicin|100 mg/m2 by vein given on day 1 and repeated once every 21 days for 4 treatments, may be given instead of Doxorubicin in Group 1 and 2.
16230407|NCT01159236|Drug|Cyclophosphamide|500 mg/m2 by vein given on day 1 and repeated once every 21 days for 4 treatments.
16230408|NCT01159236|Drug|Bevacizumab|10 mg/kg intravenously every 2 weeks, discontinued 6 weeks before surgery (i.e. after 3rd course of FEC or FAC)
16230409|NCT01159223|Drug|ATV/r|All participants will be randomized to take ATV/r 200 mg/100 mg OD or ATV/r 300/100 mg OD. NRTIs background regimens will remain unchanged if possible. NRTIs background may include zidovudine/lamivudine, zidovudine plus ddI, ddI plus lamivudine, tenofovir plus lamivudine, tenofovir/emtricitabine, zidovudine plus tenofovir. NRTI backbone could be switched or modified due to toxicity or intolerance
16230410|NCT01159210|Biological|Prothrombin complex concentrate (coagulation factors IX, II, VII and X in combination)|Intravenous infusion; regimen is guided by the pre-treatment international normalised ratio (INR); dosage and duration of replacement therapy depend on the severity of the disorder, on the location and extent of bleeding and on the patient´s clinical condition.
16230411|NCT01159197|Behavioral|cognitive behavioral therapy|Participants who randomized into the CBT group will receive 18 30-minute tri-weekly treatment sessions of CBT during the 6-week period
16230412|NCT01159171|Drug|bevacizumab [Avastin]|5 mg/kg intravenously every 14 days
16230413|NCT01159171|Drug|capecitabine [Xeloda]|1000 mg/m2 orally b.i.d. , Days 1 - 14 of every 28-day cycle
16230414|NCT01159171|Drug|oxaliplatin|40 mg/m2 iv weekly
16230415|NCT01159158|Drug|Nateglinide|Nateglinide Tablets 120 mg
16230416|NCT01159145|Drug|D961H|Oral, capsule
16230417|NCT01159145|Drug|Omeprazole|Oral, tablet
16230418|NCT01159132|Drug|raltegravir|12 hour PK will be done on day 1 while subjects is on stable regimen with RAL 400 mg BID. After performing intensive PK, subjects will be randomized to either group A (RAL 400 mg OD) or B (RAL 800 mg OD) for 14 days and on day 15, a second 24 hour full PK will be carried out. After the intensive PK, subjects in both the groups will switched to the other dosing regimen, group A (RAL 800 mg OD) and B (RAL 400 mg OD) for another 14 days and on day 29, the third 24 hour full PK will be carried out.
16230419|NCT01159119|Drug|EUR-1066-A|Eur-1066 capsules taken daily for 28 days either during treatment period 1 or treatment period 3.
16230420|NCT01159119|Drug|Zenpep|Capsules taken for daily for 28 days during treatment period 2
16230421|NCT01159119|Drug|EUR-1066-B|Eur-1066 capsules taken daily for 28 days either during treatment period 1 or treatment period 3.
16230422|NCT01159106|Other|Pressure Support Ventilation|Spontaneous mode of ventilation whereby the patient initiates the breath and the ventilator delivers support with the preset pressure value
16230423|NCT01159106|Other|Neurally adjusted ventilatory assist (NAVA)|"Gas delivery from the mechanical ventilator is triggered, controlled and cycled by the diaphragmatic EMG signal (Edi).
~The ventilator is aware of the change in diaphragmatic EMG by the insertion of a specially designed nasogastric tube with EMG electrodes that cross the diaphragm."
16230424|NCT01159093|Behavioral|Family Decision Support|Family-focused intervention includes informational vaccine reminder telephone calls prompted by an electronic health record.
16230429|NCT01159080|Drug|reduced dose tacrolimus and conventional myfortic|low dose of tacrolimus + maximum dose of myfortic target trough level of tacrolimus should be reduced to 2-5 ng/mL for 3 months after randomization and oral MPS dose increased to 540-720mg twice a day
16230430|NCT01159067|Drug|deferasirox|Given orally
16230431|NCT01159054|Drug|Extended Release Nicotinic Acid (Niaspan)|Subjects will start on 500 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1000 mg per day of Niaspan for 4 weeks, then the dose will be increased to 1500 mg of Niaspan per day for 4 weeks, after this subjects with weight of less than 60 kg will continue at 1500 mg per day of Niaspan for another 12 weeks whereas in subjects with weight of more than 60 kg the dose will be increased to 2000 mg of Niaspan per day which will be continued for 12 weeks.
16230432|NCT01159041|Behavioral|Family Focused Treatment (FFT)|FFT is designed to specifically address the developmental needs of school-aged children and their parents through an emphasis on fostering positive and supportive parent-child interactions that scaffold the development of a positive self, to help parents provide the child additional positive feedback on his/her developmentally appropriate achievements, and to enhance family and child coping. This treatment is conducted with the child and his/her parent(s) and includes education about depression, communication training, relationship enhancement, and problem-solving.
16230433|NCT01159041|Behavioral|Individual Treatment (IP)|The goals of the treatment are to foster the therapeutic relationship, to provide a supportive and empathic setting where the child can come to better understand his/her emotions/feelings and address issues underlying current symptoms. Therapeutic goals will be addressed through reflection and clarification of feelings/emotions and understanding the child's perception of the context of depressed feelings.
16230434|NCT01159028|Drug|BP1001|Study drug (BP1001) is constituted in normal saline, administered by IV on twice weekly for 28 days.
16230435|NCT01159028|Drug|BP1001 in combination with LDAC|Study drug (BP1001) is constituted in normal saline, administered by IV twice weekly for 28 days. Low dose ara-C (LDAC) is self administered twice daily for 10 consecutive days during the 28 day cycle.
16230436|NCT01159015|Drug|KetoNaph|Ophthalmic Solution administered BID for 6 weeks
16230437|NCT01159015|Drug|Vehicle|Vehicle of KetoNaph ophthalmic solution administered bid for six weeks
16230438|NCT01159002|Device|SmartPill|Qualifying patients were assigned to the study within four days of hospital admission. They all received a gastro-duodenal tube and capsule. The motility capsule (SmartPill®) was placed into the capsule delivery device (AdvanCE™, US Endoscopy) and advanced blindly into the stomach and released
16230439|NCT01158989|Device|PillCam|Within four days of hospital admission, qualifying critically ill patients were assigned to the study and received a gastro-jejunal tube and one PillCam video telemetry capsule (Given Imaging Ltd., Yoqneam, Israel). In each critical care patient, placement of the video capsule was coupled with the placement of the medically necessary feeding tube. A flexible endoscope was inserted into the patient's mouth, and then advanced into the esophagus, stomach, and upper small intestine. The capsule was placed into a capsule delivery device and released into the distal duodenum after it had passed beyond the sight of the scope; a wire was placed to facilitate passage of the feeding tube. An abdominal X-ray was obtained to confirm feeding tube tip placement.
16230440|NCT01158976|Dietary Supplement|Docosahexanoic Acid|450 mg DHA daily beginning at 16-21 weeks gestation and continuing up to time of delivery
16230441|NCT01158976|Other|Placebo|soybean oils with strawberry flavoring
16230442|NCT01158950|Drug|Tolcapone|Drug: Tolcapone 200mg (single dose) administered at study visit
16230443|NCT01158950|Other|Placebo|Placebo (200mg) administered at study visit
16230444|NCT01158937|Drug|Meropenem Infusion|Meropenem 2g infused intravenously over 30 mins (bolus infusion) Meropenem 2g infused intravenously over 3 hours (extended infusion)
16230445|NCT01158924|Drug|Intradiscal rhGDF-5|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. In vitro experiments have shown that rhGDF-5 can stimulate gene expression and synthesis of the extracellular matrix proteins type II collagen and aggrecan. In vivo experiments in rabbit models of disc degeneration have shown that intradiscal injections of rhGDF-5 can stimulate an increase in disc height and hydration.
16230446|NCT01158898|Drug|TPI ASM8|ASM8 4mg/mL (low dose) daily for 14 days by inhalation
16230447|NCT01158898|Drug|TPI ASM8|ASM8 4mg/mL (high dose) daily for 14 days by inhalation
16230448|NCT01158898|Drug|TPI ASM8|Placebo PBS solution daily for 14 days by inhalation
16230453|NCT01158859|Drug|Pregabalin|Preoperative administration of pregabalin vs placebo 1 hour before surgery
16230454|NCT01158846|Drug|prasugrel/bivalirudin|60mg loading dose followed by 10mg or 5 mg (according to body weight or age)maintenance dose of prasugrel. Bivalirudin during the primary PCI (bolus plus infusion)
16230455|NCT01158846|Drug|clopidogrel/abciximab|600mg loading dose of clopidogrel followed by 75mg maintenance dose. Abciximab will be used during primary PCI, bolus plus infusion.
16230456|NCT01158833|Other|classification of gait in diplegic children with CP|To determine the criterion validity of the classification of the pattern of diplegic gait proposed by Ferrari et al. we correlated gait patterns with the score of the FMS.
16230457|NCT01158820|Drug|Dexmedetomidine load|Dexmedetomidine 1 µg/kg prior to bronchoscopy
16230458|NCT01158820|Drug|Ketamine load|Ketamine 30 mg bolus prior to bronchoscopy
16230465|NCT01158820|Drug|Benadryl demand|25 mg bolus after 6th and 13th demand midazolam/fentanyl bolus
16230466|NCT01158781|Behavioral|Experimental: gait, balance, arm function, cognition|12 weeks of training for balance, gait, upper limb function, and cognition, including functional electrical stimulation with surface electrodes, robotics, and motor learning
16230467|NCT01158755|Drug|Moxifloxacin|Subjects on both arms will further be randomized into receiving moxifloxacin either in standard dose (400 mg p.o.), high dose (800 mg p.o.) of moxifloxacin, or not receiving moxifloxacin (ethambutol 750 mg p.o., instead) Intervention drug will be given for 14 days, and the drug will be switched to ethambutol 750 mg p.o. (in accordance with National TB Program)
16230468|NCT01158742|Other|Glomerular Filtration Rate with Iothalamate|used to determine kidney function
16230469|NCT01158742|Other|Glomerular Filtration Rate with Iohexol|used to determine kidney function
16230470|NCT01158729|Drug|Antithrombin (Recombinant)|Single dose of antithrombin (recombinant) to be given prior to initiation of cardiopulmonary bypass. Intravenous dose determined by following formula: ATIII dose given to patient = [(1.0 Units/mL - patient's measured ATIII concentration in Units/mL) X weight (kg) X 80 mL/kg] X (1 mL/175 Units)
16230471|NCT01158729|Other|Placebo|Single dose of placebo (0.9% NaCl) to be given prior to initiation of cardiopulmonary bypass. Intravenous dose determined by following formula: Placebo dose given to patient = [(1.0 Units/mL - patient's measured ATIII concentration in Units/mL) X weight (kg) X 80 mL/kg] X (1 mL/175 Units)
16230472|NCT01158716|Other|Remote Ischemic Preconditioning|Patients are subjected to a 5-minute ischemia of the non-dominant arm with the use of a blood pressure cuff (inflated at 200mm Hg)
16230473|NCT01158703|Drug|clopidogrel|clopidogrel 75mg daily by mouth daily for 12 months
16230474|NCT01158703|Drug|sugar pill|sugar pill by mouth daily for 12 months
16230475|NCT01158703|Drug|Aspirin|aspirin 81 mg daily by mouth for 12 months ( Standard of care in both arms)
16230476|NCT01158690|Other|resource card|the intervention group receives an envelop with resource card
16230477|NCT01158690|Other|no resource card|the control group receives an envelop without resource card
16230478|NCT01158677|Procedure|Meniscectomy|patients undergoing meniscectomy will be asked to complete the KOOS-scale,Vas-scale, Tegner questionnaire, SF-36 questionnaire pre-operatively and at 3, 6 and 12 months post-operatively
16230479|NCT01158664|Device|0.6 mm tread pitch implant|0.6 mm tread pitch implant will be used
16230480|NCT01158664|Device|0.1 mm tread pitch implant|0.1 mm tread pitch implant will be used
16230481|NCT01158651|Drug|RAD001 (Everolimus)|"If you take part in this research study, you will be given a participant diary for each treatment course to help you keep track of when you take your RAD001. You will be required to bring the completed diary at each scheduled visit. A treatment course lasts 4 weeks and there will not be any breaks between courses. You may stay on study for a total of 12 courses (48 weeks).
~You will take the study medication (tablets) by mouth, once a day during each course for as long as you are participating in this study. You will also be required to take an antibiotic during treatment to prevent infection."
16230482|NCT01158638|Behavioral|Web Mediated Step Intervention|The testing of a web mediated step intervention designed to set weekly step targets, and channel participants through a series of motivational screens depending on compliance or non-compliance with set step goals.
16230483|NCT01158625|Other|Change of time of administration|Change of time of administration
16230484|NCT01158612|Drug|Growth Hormone|infusion of Growth hormone in the patella tendon.
16230485|NCT01158599|Biological|IXIARO®|IXIARO®, 0.5 ml (6 µg), intramuscular (i.m.) injection, two vaccinations, Days 0 and 28
16230486|NCT01158586|Drug|Levobupivacaine|patient control epidural analgesia using 0.2% levobupivacaine with 2ug/ml fentanyl
16230487|NCT01158560|Dietary Supplement|cholecalciferol (vitamin D3)|oral capsule, 10,000 IU/week vitamin D3 for 6-8 weeks
16230488|NCT01158560|Behavioral|Gargling|gargling with tap water, twice daily
16230489|NCT01158560|Dietary Supplement|Placebo|matched placebo for active vitamin D
16230490|NCT01158534|Drug|celecoxib|Given orally
16230491|NCT01158534|Biological|recombinant interferon alfa-2b|Given subcutaneously
16230492|NCT01158534|Other|polymerase chain reaction|Correlative studies
16230493|NCT01158534|Other|laboratory biomarker analysis|Correlative studies
16230494|NCT01158534|Other|reverse transcriptase-polymerase chain reaction|Correlative studies
16230495|NCT01158534|Other|immunologic technique|Correlative studies
16230496|NCT01158534|Other|immunohistochemistry staining method|Correlative studies
16230497|NCT01158534|Other|flow cytometry|Correlative studies
16230498|NCT01158521|Drug|pazopanib hydrochloride|Oral pazopanib hydrochloride once daily for up to 18 weeks in the absence of disease progression or unacceptable toxicity.
16230499|NCT01158521|Procedure|therapeutic conventional surgery|Patients undergo either partial or radical nephrectomy at least 7 days after completion of pazopanib hydrochloride.
16230500|NCT01158508|Procedure|Remote ischemic preconditioning|Transient lower limb ischemia will be induced by inflation of a blood pressure cuff on the thigh. Four five minute cycles of ischemia will be performed, each followed by five minutes of reperfusion with the cuff down. This procedure will be performed in four rounds, typically on post-hemorrhage days 2, 3, 6 and 9.
16230501|NCT01158495|Procedure|Intubation with a cuffed ET Tube|
16230502|NCT01158495|Procedure|CT scan Radiation|
16230503|NCT01158482|Procedure|IVC Filter Placement or Retrieval|An IVC Filter will be placed or removed using endovascular techniques.
16230504|NCT01158443|Behavioral|Behavioral Activation Therapy|8 session, manualized intervention. Homework, short-term activities and goals specified, problem solving skills.
16230505|NCT01158443|Behavioral|Supportive Counseling|8 sessions of manualized supportive counseling. Frequency and duration are designed to match the Behavioral Activation arm.
16230506|NCT01158430|Behavioral|ACT group therapy|Group therapy (ACT) in groups of 9 patients in 9 weekly 3.5-hours sessions & 1 booster session 1 month after 9th session, a total of 35.5 hours
16230507|NCT01158417|Drug|Placebo|oral
16230508|NCT01158417|Drug|Resveratrol 40 mg oral three times a day|Drug
16230509|NCT01158417|Drug|Resveratrol 500 mg oral once daily.|Resveratrol 500 mg oral once daily.
16230600|NCT01157572|Drug|Metoprolol|Patients with moderate to severe aortic valve insufficiency will be randomized to Metoprolol
16230510|NCT01158404|Drug|LY900009 - Dose Escalation Phase (Part A)|"2 milligrams (mg), 4 mg, 8 mg, 15 mg, 30 mg, 45 mg and 60mg LY900009 administered orally 3 times per week (Monday, Wednesday, Friday) for 4 weeks of a 28-day cycle.
~Participants experiencing clinical benefit may continue treatment unless discontinuation criteria are met."
16230511|NCT01158404|Drug|LY900009 - Dose Confirmation Phase (Part B)|"30 mg LY900009 orally 3 times per week (Monday, Wednesday, Friday) for 4 weeks of a 28-day cycle.
~Participants experiencing clinical benefit may continue treatment unless discontinuation criteria are met."
16230512|NCT01158391|Device|NTrainer® Intervention|
16230513|NCT01158391|Device|Control Intervention|
16230514|NCT01158378|Device|Adherus Dural Sealant|In situ polymerizing sealant
16230515|NCT01158365|Drug|LACTIC ACID (Dermacid)|Route of administration: local
16230516|NCT01158365|Drug|Glycerine Vegetal Soap Granado Traditional|Route of administration: local
16230517|NCT01158352|Dietary Supplement|Nutritional supplementation formula|Nutritional supplementation formula
16230518|NCT01158352|Dietary Supplement|Placebo Comparator|Placebo low caloric formula (Powder added to liquids or food, without added vitamins and minerals
16230519|NCT01158339|Behavioral|Arm 2: CBGT-ISE|Intervention with active performance of the feared movements during group sessions.
16230520|NCT01158339|Behavioral|Arm 1: CBGT|Intervention according to previously mentioned methods.
16230521|NCT01158326|Drug|Resfenol|"Paracetamol (acetaminophen), chlorpheniramine maleate, phenylephrine hydrochloride.
~10 ml of oral solution acetaminophen, chlorpheniramine maleate, phenylephrine hydrochloride every 6 hours for 48 hours."
16230522|NCT01158326|Other|Placebo|10 ml of oral placebo every 6 hours for 48 hours
16230523|NCT01158313|Dietary Supplement|Thickened supplement|New thickener to be mixed to liquid to obtain different viscosities such as nectar viscosity, honey viscosity, conservative spoon-thick viscosity (CST) and extreme spoon-thick viscosity (EST
16230524|NCT01158300|Drug|VEGF inhibitor PTC299|This is a dose escalation study. Study participants will receive .6 or 1.2 mg/kg orally twice daily or 1.2, 1.5, or 2.0 mg/kg orally three times daily for four consecutive weeks (a course). In the absence of unacceptable toxicity or disease progression, treatment may continue for up to 12 courses (approximately one year)
16230525|NCT01158287|Drug|sorafenib tosylate|
16230526|NCT01158287|Other|laboratory biomarker analysis|
16230527|NCT01158274|Drug|gamma-secretase/Notch signalling pathway inhibitor RO4929097|Given orally
16230528|NCT01158274|Drug|capecitabine|Given orally
16230529|NCT01158274|Other|laboratory biomarker analysis|Correlative studies
16230530|NCT01158261|Biological|EVICEL ™ Fibrin Sealant (Human)|Commercial Evicel
16230531|NCT01158248|Biological|panitumumab|
16230532|NCT01158248|Drug|cisplatin|
16230533|NCT01158248|Radiation|brachytherapy|
16230534|NCT01158248|Radiation|external beam radiation therapy|
16230535|NCT01158235|Drug|LTX-109|1%, 2% and 3% Lytixar (gel formulation). TID for 3 days.
16230536|NCT01158222|Drug|sunitinib malate|Given orally
16230537|NCT01158209|Procedure|Endocervical samples|Endocervical samples collection during routine gynaecological examinations.
16230538|NCT01158196|Device|infra-red diode laser|"laser treatment of scar after keloid excision
~laser treatment of surgery scar"
16230539|NCT01158183|Drug|BAY86-5046_Interferon-beta-1b|Electronic questionnaires
16230540|NCT01158170|Radiation|Prophylactic cranial irradiation|25GY/10fraction
16230541|NCT01158170|Drug|Erlotinib /Gefitinib|Erlotinib 150mg/d or Gefitinib 250mg/d until disease progression or intolerable toxicity
16230542|NCT01158157|Biological|ACAM2000|Percutaneous administration of a droplet (2.5µg) of ACAM2000 using a bifurcated needle.
16230543|NCT01158144|Drug|Endostar|Patients with non-resectable non-small Cell Lung Cancer will receive thoracic radiation therapy 60-66 Gy over 30-33 fractions and concurrent with Endostar 7.5 mg/m2 over 3 hours d1-14, Paclitaxel 50 mg/m2 weekly over 1 hour, Carboplatin AUC = 2 mg/mL/min over 30 min weekly. Followed by Endostar 7.5 mg/m2 d1-14,Paclitaxel 175 mg/m2 d1 and Carboplatin AUC = 5 mg/mL/min d1 every 3 weeks for 2 cycles as consolidation treatment.
16230544|NCT01158144|Drug|Paclitaxel/Carboplatin|Patients with non-resectable non-small Cell Lung Cancer will receive thoracic radiation therapy 60-66 Gy over 30-33 fractions and concurrent with Paclitaxel 50 mg/m2 weekly over 1 hour, Carboplatin AUC = 2 mg/mL/min over 30 min weekly. Followed by Paclitaxel 175 mg/m2 d1 and Carboplatin AUC = 5 mg/mL/min d1 every 3 weeks for 2 cycles as consolidation treatment.
16230545|NCT01158131|Behavioral|Balance after Baby Lifestyle Intervention Program|Participants in this intervention will receive support from a lifestyle coach and gain access to a website with online presentations that contain healthy eating and physical activity educational tips. Weekly phone conversations with the lifestyle coach, as well as logging diet and physical activity will also be required of intervention participants.
16230546|NCT01158118|Drug|Sargramostim|
16230547|NCT01158118|Drug|Plerixafor|
16230548|NCT01158105|Drug|Bortezomib|1.6 mg/m2 IV infusion on days 1, 8, 15, 22 of each 35 day cycle, for up to 6 cycles.Patients who continue to respond during the initial treatment phase with no ongoing significant adverse events will be eligible to receive up to 6 additional cycles.This maintenance dose will be administered on days 1 and 15.
16230549|NCT01158092|Device|Treatment with SInergy™ System|Lateral branch denervation using the SInergy™ System
16230550|NCT01158092|Other|Conservative Treatment|Treatment with physical therapy, chiropractic care, and medication
16230551|NCT01158079|Drug|ALN-VSP02|The dose of ALN-VSP02 will be administered at the same dose level and schedule received at the completion of the previous study
16230552|NCT01158066|Procedure|CT Cardiac|the patient will undergo cardiac CT
16230553|NCT01158053|Device|FFR and VH-IVUS|"Stable Angina(SA), Unstable Angina(UA),Non ST-segment Elevation Myocardial Infarction(NSTEMI) or ST-segment Elevation Myocardial Infarction(STEMI) >48hrs scheduled for cardiac catheterization ± PCI. All patient level inclusion and no exclusion criteria are met Signed Informed Consent
~No PCI or successful and uncomplicated PCI of all non study lesions. One or more study lesions identified.
~All lesion level inclusion criteria and no exclusion criteria are met.
~FFR followed by VH-IVUS of study lesion(s)
~Any additional PCI based on routine clinical practice and FFR/IVUS data?
~If Yes: Final IVUS with VH imaging, Clinical follow-up at hospital discharge, 30 days, 6 months, and then yearly for 3 years
~If No: Clinical follow-up at hospital discharge, 30 days, 6 months, and then yearly for 3 years"
16230555|NCT01158027|Other|gait evaluation|The children will asked to walk under different conditions: (1) walking at a self-selected speed faster and slower on the GAITRite® system and on a treadmill and while listening and to a metronomeQuoting.
16230556|NCT01158014|Procedure|Fibrin Glue, Quixil|quixil 0.1 ml
16230557|NCT01158014|Procedure|Suture|vicryl 10/0
16230558|NCT01158001|Behavioral|Prolonged exposure therapy|Twelve sessions (90 minutes each) of prolonged exposure therapy
16230559|NCT01157988|Drug|ibritumomab tiuxetan (Zevalin)|During Zevalin treatment, rituximab 250 mg/m2 will be administered with the same methods mentioned above on days 1 and 8. On day 8, within 4 hours following completion of the rituximab dose, 90Y Zevalin at a dose of 0.4 mCi/kg actual body weight for patients with a platelet count > 150,000/L and 0.3 mCi/kg actual body weight for patients with a platelet count of 100,000 - 149,000/L will be injected intravenously over a period of 10 minutes. The maximum allowable dose of 90Y Zevalin is 32 mCi regardless of the patient's body weight. 90Y Zevalin should be administered within 4 hours after radiolabeling of Zevalin with 90Y.
16230560|NCT01157975|Drug|Pioglitazone|Pioglitazone will be taken at a dose of 30 mg for up to 14 days
16230561|NCT01157975|Drug|Prednisone|Prednisone will be taken at a dose of 40 mg for up to 4 days
16230562|NCT01157962|Procedure|Lymphadenectomy in cervical cancer|Sentinel lymphadenectomy vs systematic pelvic lymphadenectomy
16230563|NCT01157949|Drug|Thymoglobulin|Study patients will receive 1.5 mg/kg/day intravenously for 5 days.
16230564|NCT01157936|Drug|Allopurinol|daily dosage
16230565|NCT01157936|Other|placebo|daily dosage
16230566|NCT01157923|Device|MD Logic Pump Advisor|Insulin pump settings (i.e., basal plan, correction factor, carbohydrate ration and insulin activity time) will be adjusted using the MD-Logic Pump Advisor
16230567|NCT01157897|Biological|VMP001|Plasmodium vivax malaria protein 001 (VMP001) with GSK Biologicals' Adjuvant System AS01B
16230568|NCT01157897|Other|P. vivax sporozoite challenge|P. vivax sporozoite challenge
16230569|NCT01157871|Drug|XRP0038 (NV1FGF)|"Pharmaceutical form:solution
~Route of administration: intramuscular"
16230570|NCT01157871|Drug|placebo|"Pharmaceutical form:solution
~Route of administration: intramuscular"
16230571|NCT01157858|Drug|Everolimus|2.5 mg every day orally
16230572|NCT01157858|Drug|Octreotide LAR|40 mg every 28 days IM
16230573|NCT01157845|Device|BreathID (Methacetin breath test)|13C-labeled methacetin (75 mg) is given to the patient by mouth in a small volume of water, and expired 13C-labeled carbon dioxide is measured from a nasal cannula.
16230574|NCT01157819|Drug|0.3% Ciprofloxacin Ear Drops|4 gtt b.i.d. for 7 days.
16230575|NCT01157819|Drug|FoamOtic Cipro|0.3% Ciprofloxacin Otic Foam, 1 application, q.d. for 7 days
16230576|NCT01157806|Radiation|short course of palliative radiotherapy|5x5 Gy + XELOX 7 days after radiotherapy
16230577|NCT01157793|Drug|r-hGH|r-hGH at a dose of 0.15-1.00 mg/day administered for 48 weeks by s.c. route
16230578|NCT01157793|Drug|r-hGH|Initially no treatment for the first 24 weeks followed by administration of r-hGH at a dose of 0.15 1.00 mg/day for the next 24 weeks, by s.c. route
16230579|NCT01157780|Drug|Lovaza (fish oil)|Patients will receive fish supplementation of 1 g/kg/day with a maximum dose of 4 g/day for a 12 week period.
16230580|NCT01157767|Other|standardized regimen of exercises, including a warm-up period, ROM arm exercises, and strength training exercises.|Module I is a group of arm movements. It consists of stretching exercises coordinated with breathing exercises to restore their physical mobility, range of motion and flexibility of shoulders. Module I is to be performed daily. In Module II the exercises are a series of copyrighted, sequential movements designed to put the body in proper alignment. It is a special series of muscle movements to help establish better body alignment, as well as increased strength and flexibility of one's arms, legs, and spine, each exercise is 4 repetitions. Module III is the walking and the resistance weight training program. The walking program is whole body exercise, multi-joint, weight-bearing, low impact and for beginners to advanced.
16230581|NCT01157754|Drug|levonorgestrel and ethynilestradiol|
16230582|NCT01157741|Behavioral|C-C|Mx as H-C plus positioning follow up in the community clinic
16230583|NCT01157741|Other|C-SF|As C-C but with additional supplementary food (SF) (C-SF)
16230584|NCT01157741|Other|As C-C with additional psychosocial stimulation (PS) (C-PS)|Giving psychosocial stimulation
16230585|NCT01157741|Other|As C-C but with both SF & PS (C-SF+PS)|Giving both SF & PS
16230586|NCT01157741|Other|H-C|Follow-up at Hospital
16230587|NCT01157715|Biological|intravitreal injection of KH902|
16230588|NCT01157702|Biological|Inactivated influenza vaccine (split virus, Vero cell-derived)|One 0.5 mL dose of inactivated influenza vaccine in a pre-filled syringe, administered by intramuscular injection into the musculus deltoideus in the upper arm
16230589|NCT01157676|Procedure|Open radical cystectomy|Standard of care removal of urinary bladder.
16230590|NCT01157676|Procedure|Robotic assisted radical cystectomy|Standard of care removal of urinary bladder using DaVinci robot.
16230591|NCT01157676|Device|DaVinci robot|DaVinci robotic surgical system.
16230592|NCT01157663|Other|Adapted balance training|during 8 weeks
16230593|NCT01157663|Other|Balance Training|Balance training with unipedal standing during 8 weeks
16230594|NCT01157650|Other|Autologous mesenchymal stem cells|"The trial is divided in three phases:
~I. - Selection: Patients evaluation for study eligibility will take place within two weeks after Informed Consent signature.
~II.- Treatment phase includes:
~Liposuction procedure to obtain adipose tissue.
~Processing and production of Autologous Mesenchymal Stem Cells from adipose tissue (ASCs)
~ASCs implant
~III.- Follow up: Study visits post-implant will take place at the 1st week (+/- 3 days), 4th week (+/- 3 days), 8th week (+/- 7 days), 12nd week (+/- 7 days), 24th week (+/- 7 days), and 1 year (+/- 7 days) after implant."
16230595|NCT01157624|Drug|oxygen|Subjects who are found to desaturate during treatment with air will be supplement with oxygen
16230596|NCT01157624|Drug|oxygen|Subjects who are found to desaturate during treatment with air will be supplement with oxygen
16230597|NCT01157611|Behavioral|Mentoring program|mentoring program group patients should register their SMBG, exercise, food intake and insulin dose on the website designed for this study and receive advices of mentors from peer group.
16230598|NCT01157598|Device|bispectral index monitoring|parameter monitoring of bispectral index
16230599|NCT01157585|Drug|paliperidone ER|8 week prospective study
16230601|NCT01157572|Drug|Placebo|Patients with moderate to severe aortic valve insufficiency will be randomized to Placebo
16230602|NCT01157559|Drug|Ziprasidone|8 week prospective study
16230603|NCT01157546|Procedure|Normal saline via TAP catheters|A bolus of normal saline (20 mL per side) followed by a continuous infusion of normal saline (7 ml/h per side. The infusions will be started after the bolus doses and continued postoperatively for 48 hours.
16230604|NCT01157546|Procedure|Lidocaine via TAP catheters|A bolus of lidocaine 1% with epinephrine 1:200 000 (20 mL per side) followed by a continuous infusion of ropivacaine 0.2% (7 mL/h per side). The infusions will be started after the bolus doses and continued postoperatively for 48 hours.
16230605|NCT01157533|Drug|Vancomycin|Loading dose 30 mg/kg via central or peripheral intravenous infusion. Subsequent doses of vancomycin (15 mg/kg) are considered standard of care.
16230606|NCT01157507|Drug|Intravesical injection of Botulinum A Toxin|One treatment, 100 U vials diluted in 10 ml normal saline
16230607|NCT01157507|Procedure|Bladder overdistension|Bladder overdistension
16230608|NCT01157507|Drug|Placebo|One single injection of placebo
16230609|NCT01157494|Other|classification of hand manipulation function|To determine the criterion validity of the classification of the pattern of manipulation proposed by Ferrari et al. we correlated hand manipulation classes with both the scores of the two standard criteria chosen (AHA and Melbourne Assessment).
16230610|NCT01157481|Drug|Conventional therapy plus nifedipine|Participants will receive 10 to 60 mg of sustained-release nifedipine once a day until December 2014
16230611|NCT01157481|Drug|Conventional therapy|Conventional therapy
16230612|NCT01157455|Procedure|Everolimus Drug Eluting Stent|Implantation
16230613|NCT01157455|Drug|Aspirin|Orally take by 300mg per day at least within 24 hours before index procedure. Orally 100mg indefinitely after the procedure as a part of dual anti-platelet therapy
16230614|NCT01157455|Drug|Clopidogrel|"A loading dose of 300mg must be given at least 6 hours prior to index procedure, or a loading dose of 75mg/d 72 hours prior to index procedure.
~75mg daily for at least 12 months after the procedure as a part of dual anti-platelet therapy."
16230615|NCT01157455|Drug|Heparin or Bivalirudin|During procedure or in-hospital, Heparin 100u/kg or Bivalirudin may be given,or follow up the standard practice of each site.
16230616|NCT01157442|Behavioral|cell phone sms text messaging|At enrollment a study nurse will send the intervention group a weekly SMS message reminding them to attend antenatal care. Starting at 36 weeks gestational age, an automated bulk SMS management system, will send the intervention group 3 SMS text messages (using non descript slogans) each week by proxy reminding them to take their nevirapine in labor. From time of delivery to 6 weeks postpartum the women will aslo receive 3 SMS messages per week reminding them to attend their 6 week checkup and 6 week infant visit.Upon receiving these messages women in the intervention group can text back if they have any concerns or questions. These women would then receive phone calls from the study nurse triaged according to the women's needs.
16230617|NCT01157429|Drug|D-cycloserine|D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol.
16230618|NCT01157429|Drug|Placebo pill|Placebo pill by mouth prior to sessions 5-12 of teh 12-session CBT protocol.
16230619|NCT01157429|Behavioral|CBT|12-session CBT protocol, called Youth PTSD Treatment.
16230620|NCT01157416|Drug|D-cycloserine|D-cycloserine 50 mg by mouth prior to sessions 5-12 of the 12-session CBT protocol.
16230621|NCT01157416|Drug|Placebo pill|Placebo pill by mouth prior to sessions 5-12 of the 12-session CBT protocol.
16230622|NCT01157416|Behavioral|CBT|12-session CBT protocol, called Youth PTSD Treatment.
16230623|NCT01157403|Biological|Autologous transplantation|Autologous transplantation of bone marrow mesenchymal stem cells (approximately 2.5 x 106 cells/kg body weight) intravenously
16230624|NCT01157390|Other|Infant formula|Name: Infant formula with high proportion of palmitic acid in the sn-2 position Dosage & frequency: Fed as need Duration: at least 3 months
16230625|NCT01157390|Other|Breast feeding|Breast feeding
16230626|NCT01157377|Drug|AGN-214868|AGN-214868 injected into the bladder.
16230627|NCT01157377|Drug|AGN-214868 placebo|AGN-214868 placebo injected into the bladder.
16230628|NCT01157364|Drug|bimatoprost 20 µg generation 2|Single dose of bimatoprost ophthalmic administered in the study eye on Day 1.
16230629|NCT01157364|Drug|bimatoprost 15 µg generation 2|Single dose of bimatoprost ophthalmic administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
16230630|NCT01157364|Drug|bimatoprost 10 µg generation 2|Single dose of bimatoprost ophthalmic 10 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
16230631|NCT01157364|Drug|bimatoprost 6 µg generation 2|Single dose of bimatoprost ophthalmic 6 µg generation 2 administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
16230632|NCT01157364|Drug|bimatoprost 15 µg generation 1|Single dose of bimatoprost ophthalmic 15 µg generation 1 administered in the study eye on Day 1.
16230633|NCT01157364|Drug|bimatoprost 10 µg generation 1|Single dose of bimatoprost ophthalmic 10 µg generation 1 administered in the study eye on Day 1.
16230634|NCT01157364|Drug|bimatoprost 0.03%|One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
16230635|NCT01157351|Drug|paliperidone|flexible dosing as prescribed by the study doctor for 15 months
16230636|NCT01157351|Drug|risperidone|flexible dosing as prescribed by the study doctor for 15 months
16230637|NCT01157351|Drug|haloperidole|flexible dosing as prescribed by the study doctor for 15 months
16230638|NCT01157351|Drug|perphenazine|flexible dosing as prescribed by the study doctor for 15 months
16230639|NCT01157351|Drug|aripiprazole|flexible dosing as prescribed by the study doctor for 15 months
16230640|NCT01157351|Drug|quetiapine|flexible dosing as prescribed by the study doctor for 15 months
16230641|NCT01157351|Drug|paliperidone palmitate|78, 117, 156, or 234 mg monthly injection for 15 months
16230642|NCT01157351|Drug|olanzapine|flexible dosing as prescribed by the study doctor for 15 months
16230643|NCT01157338|Procedure|diagnostic cardiac catheterization|coronary intervention: angiography
16230644|NCT01157338|Procedure|therapeutic cardiac catheterization|cardiac catheterization: angioplasty
16231280|NCT01152749|Drug|Nicotine Gum|Single-dose of marketed nicotine gum
16230645|NCT01157325|Procedure|Neuraxial analgesia|Neuraxial analgesia will be given at any time if the parturient requested analgesia
16230646|NCT01157325|Procedure|Non-neuraxial analgesia|No neuraxial analgesia will be given to those who will not want to an analgesia
16230647|NCT01157312|Drug|clomiphene citrate +highly purified uFSH|
16230648|NCT01157312|Drug|clomiphene citrate|
16230649|NCT01157260|Drug|Kremezin|AST-120 2g three times a day
16230650|NCT01157247|Procedure|Comparison of intravenous fentanyl and local anesthetic infiltration in pain reducing during spinal needle puncture|
16230651|NCT01157234|Drug|Nebivolol|Nebivolol 5 mg once daily, titrated to a maximum total daily dose of 40 mg to achieve a blood pressure of < 140/ 90.
16230652|NCT01157234|Drug|Metoprolol|Metoprolol 25 mg twice daily, titrated to a maximum total daily dose of 400 mg to achieve a blood pressure < 140/90.
16230653|NCT01157221|Other|a standardized physical therapy program|passive mobilization, stretching techniques, physical modalities (i.e., ultrasound, shortwave diathermy, and/or electrotherapy), and active exercises
16230654|NCT01157221|Other|EMSMTA|end-range mobilization/scapular mobilization treatment approach
16230655|NCT01157208|Other|Diet A|Subjects receive dietary counseling, food for two meals and two snacks daily, and access to a website with recipes, approved food lists, and dining out guides for a 12-week intervention.
16230656|NCT01157208|Other|Diet B|Over a 12-week intervention, subjects receive dietary counseling, food for two meals and two snacks daily, and access to a website with recipes, approved food lists, and dining out guides.
16230657|NCT01157195|Behavioral|Tele-AutoCITE|Automated, remotely-administered form of CI therapy
16230658|NCT01157195|Behavioral|CI therapy|CI therapy is a behavioral approach to physical rehabilitation that has three components: 1. intense training of the more affected arm for several hours daily for multiple consecutive days, 2. restraint of the less affected arm during training hours and afterwards during the treatment period, 3. A package of behavioral techniques designed to transfer gains from the treatment setting to daily life. In this trial, CI therapy will be administered for 3 1/2 hours per day for 10 consecutive weekdays.
16230659|NCT01157182|Drug|Estradiol/Norethindrone acetate|1/0.5 mg Tablets
16230660|NCT01157182|Drug|Activella®|1/0.5 mg Tablets
16230661|NCT01157169|Drug|Buprenorphine|8 mg Sublingual Tablets
16230662|NCT01157169|Drug|Buprenorphine|8 mg Sublingual Tablets
16230663|NCT01157156|Drug|XRP0038 (NV1FGF)|"Pharmaceutical form:solution
~Route of administration: intramuscular"
16230664|NCT01157143|Drug|XRP0038 (NV1FGF)|"Pharmaceutical form : solution
~Route of administration : intramuscular"
16230665|NCT01157130|Other|Exercise Regimen|Exercise instruction
16230666|NCT01157117|Biological|Placebo for omalizumab|Placebo for omalizumab is injected subcutaneously every 2-4 weeks for 16 months at a volume designed to match that of the verum treatment group (determined by the participant's IgE level and weight).
16230667|NCT01157117|Biological|Omalizumab|Omalizumab is injected subcutaneously every 2-4 weeks for 28 months at a dose determined by the participants IgE level and weight.
16230668|NCT01157117|Drug|Milk powder|Milk powder is ingested orally at a dosage of up to 3.84 grams of of milk protein daily from Month 4 through Month 28 if the Month 28 10 g milk OFC is failed, and through Month 30 if the Month 28 10 g milk OFC is passed.
16230669|NCT01157104|Drug|IDX320|IDX320 400 mg in tablets (8x50 mg) administered orally once daily
16230670|NCT01157104|Drug|IDX184|IDX184 100 mg in capsules (2x50 mg) administered orally once daily
16230671|NCT01157104|Drug|IDX184 placebo|IDX184 matching placebo in capsules administered orally once daily
16230672|NCT01157104|Drug|IDX320 placebo|IDX320 matching placebo in tablets administered orally once daily
16230673|NCT01157091|Drug|pazopanib hydrochloride|Given orally
16230674|NCT01157091|Other|laboratory biomarker analysis|Correlative studies
16230675|NCT01157091|Other|immunologic technique|Correlative studies
16230676|NCT01157078|Drug|TC-5214|Tablet, oral, twice daily for 8 weeks
16230677|NCT01157078|Drug|Placebo|Tablet, oral, twice daily for 8 weeks
16230678|NCT01157065|Drug|AL-78898A|Investigational treatment
16230679|NCT01157065|Drug|Ranibizumab|Anti-vascular endothelial growth factor (VEGF) treatment
16230680|NCT01157052|Other|(supplement) Calcium and Magnesium|"FOLFOX 6: Oxaliplatin (Eloxatin®): 100mg/m2 x 2hrs IV with 250ml of dextrose 5%; leucovorin 200mg/m2 with oxaliplatin; then IV bolus of 5FU 400mg/m2 and 5FU 2400mg/m2 in a 46 hr continuous IV. Each cycle is 14 days, approximately 8-12 cycles planned.
~XELOX: Oxaliplatin 130mg/m2 x 2hrs IV in 250ml of dextrose 5% on day 1; plus oral capecitabine 1000mg/m2 bid on days 1-15 3 wk cycles.
~Ca2+/Mg2: Ca++gluconate 1gr & Mg++sulfate 1g given IV pre & post cycle 1 (Arm A) or cycle 2 (Arm B)"
16230681|NCT01157039|Dietary Supplement|Glutamine|Glutamine- During the first cycle of oxaliplatin based combination therapy (mFOLFOX 6 or XELOX) no patient will receive glutamine. At cycle 2, patients will be randomized to receive for 6 days either : Glutamine 30g/day during cycle 2 and glutamine 40g/day during cycle 3 (ARM A) or glutamine 40g/day at cycle 2 and glutamine 30g/day at cycle 3 (Arm B).
16230682|NCT01157026|Dietary Supplement|Tocotrienol Rich Fraction (TRF)|Tocotrienol Rich Fraction (200mg), daily for five years
16230683|NCT01157026|Other|placebo plus tamoxifen|20mg tamoxifen daily
16230684|NCT01157013|Other|Positron emission tomography with fludeoxyglucose F 18|Patients receive fludeoxyglucose F 18 (^18FDG) IV. Beginning 1 hour later, patients undergo whole-body positron emission tomography (PET) scanning. Patients also undergo conventional radiographic staging of their disease.
16230685|NCT01157000|Drug|Canagliflozin|On Day 1, all patients will receive a single 300-mg tablet of canagliflozin with 8 ounces of water followed 105 minutes later by a 15-minute intravenous infusion dose (15 mL) of 10 mcg of 14C-canagliflozin (200 nCi).
16230686|NCT01156987|Device|Magnetic resonance imaging|"Patients and healthy volunteers will be first screened for MRI contraindications. The SWIFT MRI workflow will be performed as follows:
~an IV line is placed by nurse,
~patient is placed in the 4 T MRI scanner at CMRR,
~initial scout images and manual linear shims are adjusted,
~Pre-contrast SWIFT T1 weighted images and T1 map are obtained,
~continuous SWIFT acquisition begins immediately before contrast injection,
~contrast injection,
~continuous SWIFT acquisition continues for 12 min after contrast,
~late enhancement images may also be obtained.
~10 and 30 patients will be scanned in the first and second year, respectively. Thresholds will be set for prospective analysis. SWIFT-DCE diagnostic performance will be compared to prior FLASH-DCE methods."
16230687|NCT01156974|Behavioral|education and care guide|Patients receive education about care goals, and in-person and telephone counseling of unspecified frequency over one year to achieve goals
16230688|NCT01156974|Behavioral|education only|patients receive education about care goals
16230689|NCT01156961|Drug|bevacizumab [Avastin]|10 mg/kg iv every 2 weeks or 15 mg/kg iv every 3 weeks
16230690|NCT01156961|Drug|paclitaxel|90 mg/m2 iv days 1, 8 and 15 of every 28-day cycle or 175 mg/m2 iv day 1 of each 21-day cycle
16230691|NCT01156948|Drug|misoprostol|400ug vaginally the day before surgery
16230692|NCT01156948|Drug|oral misoprostol|400ug misoprostol orally the day before the surgery
16230693|NCT01156935|Other|Laugh Yoga|1 hour including laugh, respiratory exercises and guided imagination by a group instructor specialized in laugh yoga
16230694|NCT01156922|Drug|Rituximab|"Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart, followed by maintenance Rituximab infusions 500 mg/m2 (max 1000 mg) at 3, 6, 10, and 15 months.
~For up to 5 patients in the study, standard plasma exchange (one plasma volume, up to 5 treatments, during 1-2 weeks) will be performed 2-3 weeks prior to start of Rituximab therapy.
~Amendment: for patients with gradual improvement in CFS/ME symptoms after 12 months follow-up, but not having reached a clear response, up to 6 additional Rituximab infusions (500 mg/m2, max 1000 mg) may be given during the following 12 months period."
16230695|NCT01156909|Drug|Rituximab|"Two infusions of Rituximab 500 mg/m2 (max 1000 mg) given two weeks apart, followed by maintenance Rituximab infusions 500 mg/m2 (max 1000 mg) at 3, 6, 10, and 15 months.
~Approved amendment: for patients with gradual improvement in CFS/ME symptoms after 12 months follow-up, but not having reached a clear response, up to 6 additional Rituximab infusions (500 mg/m2, max 1000 mg) may be given during the following 12 months period."
16230696|NCT01156896|Dietary Supplement|Ferrous sulfate|Ferrous sulfate, ~1 mg Fe/kg body weight, given as a single dose in the fasting state.
16230697|NCT01156896|Dietary Supplement|Ferrous sulfate|Ferrous sulfate, ~1 mg Fe/kg body weight, given as a single dose with a standard Thai rice meal.
16230698|NCT01156896|Dietary Supplement|Ferrous sulfate|Ferrous sulfate, ~1 mg Fe/kg body weight, given as a single dose with a standard Thai rice meal with added oil.
16230699|NCT01156896|Dietary Supplement|Ferrous sulfate|Ferrous sulfate, ~0.1 mg Fe/kg body weight, given as a single dose with a standard Thai rice meal.
16230700|NCT01156883|Drug|asparaginase|
16230701|NCT01156883|Drug|cyclophosphamide|
16230702|NCT01156883|Drug|cytarabine|
16230703|NCT01156883|Drug|daunorubicin hydrochloride|
16230704|NCT01156883|Drug|dexamethasone|
16230705|NCT01156883|Drug|doxorubicin hydrochloride|
16230706|NCT01156883|Drug|ifosfamide|
16230707|NCT01156883|Drug|mercaptopurine|
16230708|NCT01156883|Drug|methotrexate|
16230709|NCT01156883|Drug|methylprednisolone|
16230710|NCT01156883|Drug|prednisone|
16230711|NCT01156883|Drug|thioguanine|
16230712|NCT01156883|Drug|vincristine sulfate|
16230713|NCT01156883|Drug|vindesine|
16230714|NCT01156870|Drug|SAR566658|"Pharmaceutical form:solution for infusion
~Route of administration: intravenous"
16230715|NCT01156857|Drug|PGL4001, placebo|PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of placebo (oral tablets).
16230716|NCT01156857|Drug|PGL4001, progestin|PGL4001 10mg once daily (oral tablets) for 3 months followed by a period of 10 days of progestin Norethisterone acetate 10mg once daily (oral tablets).
16230717|NCT01156844|Drug|Indacaterol|Indacaterol inhaled via Concept1, a single dose dry powder inhaler (SDDPI) for 16 days. Dosage and frequency varied according to randomization scheme.
16230718|NCT01156844|Drug|Placebo to Indacaterol|Placebo inhaled via Concept1, a SDDPI. Frequency varied according to randomization scheme.
16230719|NCT01156805|Other|Educational program|The intervention consisted of the promotion of healthy eating habits and physical activity by means of the educational methodology Investigation, Vision, Action and Change (IVAC). At the beginning and at the end of 1st phase of the study (2006 and 2008) the weight and height of each child was measured in situ, while the families were given a self-report physical activity questionnaire and the Krece Plus quick test
16230720|NCT01156792|Drug|FP 100|FP 100mcg BID
16230721|NCT01156792|Drug|GSK2190915 100|GSK2190915 100mg QD (AM)
16230722|NCT01156792|Drug|GSK2190915 300|GSK2190915 300mg QD (AM)
16230723|NCT01156792|Drug|montelukast|montelukast 10mg QD (PM)
16230724|NCT01156792|Drug|placebo|placebo BID
16230725|NCT01156792|Drug|FP/SAL 100/50|FP/SAL 100/50mcg BID
16230726|NCT01156779|Drug|SR-exenatide|Emulsion 0.5mg,1mg,2mg,4mg dosage (Dose-escalation) Single injection
16230727|NCT01156766|Device|- locking anterior plate|"The number of osteoporotic fractures, among which the fractures of the lower extremity of the radius (16 % of fractures seen in emergencies) is going to increase. Several surgical techniques are described in particular locking plates and intrafocal pinning techniques.
~The aim of the study is to compare (X-ray assessments and functional outcome) these two types of treatment by using a prospective, randomised multicentric analysis."
16230728|NCT01156753|Drug|CDX-011|CDX-011 (1.88 mg/kg) administered as an intravenous infusion on Day 1 of each 21 day cycle.
16230729|NCT01156753|Drug|"Investigator's Choice chemotherapy"|Any of the following single-agent chemotherapy may be given at the discretion of the investigator, with a cycle length not to exceed four weeks: Capecitabine, Vinorelbine, Gemcitabine, Docetaxel, Paclitaxel, Albumin-bound paclitaxel, Doxorubicin HCL, Liposomal doxorubicin, Ixabepilone and Eribulin.
16230730|NCT01156740|Drug|Penicillin G, Benzathine|IM BPG; 600,000 U > 27kg or 1,200,000 U <27 kg)
16230731|NCT01156740|Drug|Amoxicillin|750 mg/QD
16230732|NCT01156714|Behavioral|Treadmill training with aerobic exercise|walk on treadmill for aerobic exercise
16230733|NCT01156714|Behavioral|Memory training with computerized memory program|memory testing and training on computer program
16230734|NCT01156714|Behavioral|Combination of treadmill training and computerized memory|both exercise and cognitive computer training
16230735|NCT01156701|Drug|Receiving a prescription of Relenza for prophylaxis|Receiving a prescription of Relenza for prophylaxis
16230736|NCT01156701|Other|No prophylaxis with Relenza|No prophylaxis with Relenza
16230737|NCT01156688|Drug|Misoprostol|sublingual 800mcg misoprostol 48 hours after oral 200mg mifepristone
16230738|NCT01156688|Drug|Misoprostol|buccal misoprostol 800mcg 48 hours after oral 200mg mifepristone
16230739|NCT01156675|Device|FLEXUS(TM) Interspinous Spacer|Treatment of lumbar spinal stenosis with the FLEXUS™ Interspinous Spacer
16230740|NCT01156675|Device|XSTOP® Interspinous Spacer|Treatment of lumbar spinal stenosis with the XSTOP® Spacer
16230741|NCT01156662|Device|Endeavor resolute or Resolute integrity (Medtronic)|PCI without thrombus aspiration
16230742|NCT01156662|Device|Export Aspiration Catheter, Endeavor resolute or Resolute integrity (Medtronic)|PCI after thrombus aspiration
16230743|NCT01156649|Device|PAP therapy|Nightly use of automatic positive airway pressure delivered at therapeutic levels and to be delivered through a nasal interface device selected to maximize comfort for each child.
16230744|NCT01156649|Device|Sham PAP therapy|During sleep, the sham PAP device will administer a constant pressure of subtherapeutic air (approximately 1 cm of water) through a custom fit nasal interface chosen for the child's maximum comfort.
16230745|NCT01156636|Drug|Sildenafil|50 mg 3 times/day for 1 year
16230746|NCT01156636|Drug|Placebo|
16230747|NCT01156623|Procedure|EBUS-TBNA|All included patients received TBNA for lymph node study via a flexible ultrasonic bronchoscope with a linear scanning probe on the tip (BF-UC206F-OL8, Olympus). The curved-probe scanned parallel to the insertion direction of bronchoscope, and the obtained images were linked to the ultrasound scanner (EU-2000C, Olympus) incorporated with Doppler-flow imaging. Each lymph node greater than 5mm in short axis measured by cursors was selected for subsequent TBNA with a 22-gauge (NA-201SX-4022, Olympus) needle in a condition of real-time EBUS guidance. A cytology examination was sent for pathologist blinded for the clinical history and image result of patients. When a tissue core was obtained by TBNA, the specimen was also sent for pathology study.
16230748|NCT01156610|Behavioral|Tobacco Treatment|"Comparison of integrated cessation counseling tools with the normal standard of care.
~Both the intervention and control clinics will be provided with tools for visit-based best practices for tobacco cessation. The LMR will provide smoking status icons and tobacco treatment reminders for the primary care physicians at the time of a visit. In addition, physicians in both arms have access to decision support around medications prescribed, including bupropion and varenicline. Physicians can refer patients to tobacco cessation groups that meet periodically at each of the sites or to the Massachusetts tobacco quitline.
~Outcome Assessment: Six month IVR Call: Patients in both the intervention and control practices who have not opted-out will be called six months after completing the 12-week treatment protocol. The outcome assessment script will be largely the same for intervention and control practices (except for the questions related to satisfaction with the intervention protocol)."
16230749|NCT01156597|Drug|pioglitazone|30 mg daily for three weeks increase to 45 mg daily for 21 more weeks
16230750|NCT01156584|Biological|Toca 511 vector|Single, stereotactic, transcranial, intratumoral injection or intravenous injection
16230751|NCT01156584|Drug|Toca FC|4-6 week cycles of Toca FC. Doses evaluated from 120 mg/kg/day or 300 mg/kg/day. Duration of dosing evaluated: 6 days, 7 days or 14 days.
16230752|NCT01156571|Drug|cangrelor P2Y12 (platelet) inhibitor|
16230753|NCT01156571|Drug|Clopidogrel - 300 or 600 mg (study arm)|Over encapsulated tablets.
16230754|NCT01156571|Drug|Clopidogrel 600 mg post cangrelor|over-encapsulated clopidogrel (600 mg)
16230755|NCT01156545|Drug|BIBW 2992|BIBW 2992 40mg, once a day, oral intake, every day
16230756|NCT01156545|Drug|simvastatin|simvastatin 40mg, once a day, oral intake, every day.
16230757|NCT01156519|Other|Salivary Cortisol|"Day 1: 1st salivary cortisol at 23 hours
~Day 2: 2nd salivary cortisol at 23 hours and administration of dexamethasone (for overnight 1-mg dexamethasone suppression test)
~Day 3: serum cortisol at 8 am
~Between Day 4 and Month 3: if serum cortisol at 8 am > 18ng/mL:
~Cortisol for 24 hours
~dexamethasone suppression test (2mg/j during 2 days)
~Cortisol and ACTH cycle
~Noriodocholesterol scintigraphy"
16230758|NCT01156493|Other|Protein Hydrolyzed Premature Formula|Infants will be fed with a protein hydrolyzed premature formula until they reach full feeds
16230759|NCT01156480|Drug|hydrocortisone|Subjects in hydrocortisone group will receive 3mg/kg/day divided every 8 hours via IV route for 3 days, followed by 2mg/kg/day divided every 8 hours IV for 1 day, followed by 1.5mg/kg/day divided every 8 hours IV for 1 day, followed by 1mg/kg/day divided every 12 hours for 1 day, followed by 0.5mg/kg/day in single dose for one day. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
16230760|NCT01156480|Drug|placebo|Subjects in placebo group will receive a volume of placebo equal to the hydrocortisone group, on the same dosing schedule, with doses given every 8 hours via IV route for 3 days, followed by placebo every 8 hours IV for 1 day, followed by placebo every 8 hours IV for 1 day, followed by placebo every 12 hours for 1 day, followed by placebo in single dose for one day. The first dose of study drug will be given within 6 hours of diagnosis of NEC, once informed consent is obtained, and subjects will continue to receive study drug until all doses have been given (total of 18 doses) or consent is withdrawn.
16230761|NCT01156467|Device|Neurally adjusted ventilatory assist, i-Servo, Maquet Nordic (Solna, Sweden)|Treatment with Edi-catheter
16230762|NCT01156467|Device|Control group, ventilation with i-Servo or Stephanie|Ventilatory support is given as routinely is done in the neonatal intensive care unit, with the ventilators available. Normal nasogastric tube is used.
16230763|NCT01156454|Procedure|X-ray|surgical specimen taken to radiology and contents x-rayed
16230764|NCT01156441|Procedure|surgical mitral valve repair w/ mitral valve annuloplasty|"Mitral valve repair will be performed via median sternotomy, utilizing cardiopulmonary bypass and moderate hypothermia. The mitral valve will be approached through a left atrial incision. Following inspection of the valve, mitral valve annuloplasty will be accomplished with a complete semi-rigid annuloplasty ring. Additional techniques to address residual regurgitation will be at the discretion of the surgeon. The left atriotomy will then be closed and the patient weaned off and separated from the cardiopulmonary bypass.
~Intraoperative transesophageal echocardiography will be performed on all study volunteers."
16230765|NCT01156415|Drug|AGO178|
16230766|NCT01156415|Drug|AGO178|
16230815|NCT01156064|Device|Confocal Laser Endomicroscopy (Pentax/Optiscan)|Confocal laser endomicroscopy is performed using the Pentax/Optiscan confocal endomicroscopy and 5 ml of 10% intravenous fluorescein sodium. Photos of magnified images of the digestive mucosa are taken during the procedure.
16230767|NCT01156402|Behavioral|Healthy Families-Childhood Obesity Prevention and Oral Health|The active intervention was adapted from the We Can! parent intervention to be culturally-appropriate for Hispanic families of children ages 5-7. The tailored intervention is based on Social Cognitive Theory and Behavioral Choice Theory to provide parents and children with cognitive and behavioral skills to enable change in the target behaviors, and to encourage them to practice using these skills to strengthen their perceived competence in using these behaviors effectively.
16230768|NCT01156389|Drug|Ritonavir and pyronaridine/artesunate|100 mg ritonavir (one soft gelatin capsule twice per day over 17 days, the evening capsule on day 1 will be omitted) and pyronaridine/artesunate 180 mg/60 mg (3 to 4 tablets once per day according to weight for 3 days).
16230769|NCT01156389|Drug|pyronaridine/artesunate|Pyronaridine/artesunate 180 mg/60 mg (3 to 4 tablets once per day according to weight for 3 days).
16230770|NCT01156376|Device|Potassium Oxalate without Fluoride|1.40% Potassium Oxalate Sensitive Mouthwash without fluoride - Rinse with 10ml for 60 seconds, four times daily successively at 1 hour intervals for five days
16230771|NCT01156376|Device|Potassium Oxalate with Fluoride|1.40% Potassium Oxalate Sensitive Mouthwash with fluoride - Rinse with 20ml for 60 seconds, four times daily successively at 1 hour intervals for five days
16230772|NCT01156376|Device|Active Comparator PO-116-A|Rinse with comparator mouthwash 20ml for 30 seconds, four times daily successively at 1 hour intervals for five days
16230773|NCT01156363|Procedure|Dialysis|regular haemodialysis or peritoneal dialysis
16230774|NCT01156363|Drug|methoxy polyethylene glycol-epoetin beta [Mircera]|once monthly, subcutaneously or intravenously, for 32 weeks
16230775|NCT01156350|Drug|Busulfan - Fludarabine - TBI|This RICE NK protocol is a multicenter study of Haplo- HSCT using RIC with fludarabine (180 mg/m2), Busulfan IV (3,2 to 4,8 mg/kg/d), TBI 2 grays and CD3/CD19 graft depletion. A minimum of 8 106 CD34+ cells/kg were infused on day 0. No post grafting immunosuppression was applied if the graft contained < 2.5 x 104 CD3+ cells/kg
16230776|NCT01156324|Behavioral|Online Stress Management Group (Upliv)|Personalized online stress management program
16230777|NCT01156324|Behavioral|Control|Control group receiving routine care along with $50 gift certificate at end of cycle
16230778|NCT01156311|Drug|dimethyl fumarate|Days 1-7: 120 mg three times a day (TID) for a total daily dose of 360 mg. Day 8 to Week 24: 240 mg TID for a total daily dose of 720 mg. Drug supplied as a capsule taken orally.
16230779|NCT01156285|Other|Filling in a patient questionnaire|Filling in a patient questionnaire
16230780|NCT01156272|Device|ATS Medical 3f® Aortic Bioprosthesis, Model 1000 19mm|Replacement aortic heart valve
16230781|NCT01156259|Radiation|3D-CRT based Involved Field Radiotherapy|CT simulation, 3D-CRT or IMRT techniques, Involved Field Radiotherapy of 30Gy
16230782|NCT01156259|Radiation|3D-CRT based Involved Field Radiotherapy|CT simulation, 3D-CRT or IMRT techniques, Involved Field Radiotherapy of 40Gy
16230783|NCT01156246|Drug|Dapagliflozin/Metformin|oral fixed dose combination tablet 5 mg Dapagliflozin / 1000 mg Metformin given on day 1 at visit 2 and 3.
16230784|NCT01156233|Procedure|Anesthesia induction|Cuff palpation technique: identification of the cuff position in the trachea by palpation.
16230785|NCT01156233|Procedure|Anesthesia induction|Right mainstem intubation, identification of the tube tip position in the trachea by withdrawing the tube from the right mainstem until good quality breath sound in the left axilla are available.
16230786|NCT01156220|Drug|Furosemide|Injection, 40 mg, single dose over 5 min
16230787|NCT01156220|Drug|aminohippurate sodium|Injection, 500 mg, single dose over 5 min
16230788|NCT01156207|Drug|Aliskiren|300mg Aliskiren qd for 6 month
16230789|NCT01156194|Drug|Homeopathy 1|Arnica montana C6 and Bellis perennis C6
16230790|NCT01156194|Drug|Homeopathy 2|Arnica montana C30 and Bellis perennis C30
16230791|NCT01156194|Drug|Placebo|globule identical to true homeopathy comparators
16230792|NCT01156181|Procedure|Cervical discharge removal|Cervical discharge will be removed using a cotton swab before embryo transfer during ICSI cycles
16230793|NCT01156181|Procedure|control|Embryo transfer without any intervention
16230794|NCT01156168|Genetic|DNA analysis|
16230795|NCT01156168|Genetic|gene expression analysis|
16230796|NCT01156168|Genetic|polymorphism analysis|
16230797|NCT01156168|Genetic|protein expression analysis|
16230798|NCT01156168|Other|immunohistochemistry staining method|
16230799|NCT01156168|Other|laboratory biomarker analysis|
16230800|NCT01156155|Radiation|Digital xray of jaw and teeth|one time xray of jaw and teeth
16230801|NCT01156155|Procedure|Blood draw|Three to four tablespoons of blood drawn.
16230802|NCT01156155|Other|questionnaires|completed questionnaires regarding patient's health and functional ability.
16230803|NCT01156155|Procedure|Periodontal Examination|Periodontal examination including measurement of gum pockets with a probe. Bacterial samples taken.
16230804|NCT01156155|Other|Bilateral digital xray of hands|One time digital xray of hands
16230805|NCT01156142|Drug|doxepin hydrochloride|Oral rinse
16230806|NCT01156142|Other|placebo|Oral rinse
16230807|NCT01156129|Drug|stool softener|ducosate sodium, Milk of Magnesia, dulcolax
16230808|NCT01156129|Device|Arm B: Acupressure bracelet|Bioband
16230809|NCT01156129|Dietary Supplement|sugar free gum|Orbit
16230810|NCT01156116|Device|CPAP mask|"The subjects who are randomized to CPAP treatment will undergo an overnight CPAP titration in the laboratory, which will be performed manually by a registered technician according to American Academy of Sleep Medicine (AASM) guidelines .Subjects will be admitted in the early evening and will receive positive airway pressure education, hands on demonstration, careful mask fitting and acclimatization prior to titration. The goal during the titration will be to determine the optimal CPAP pressure setting that eliminates obstructive respiratory events, restore oxygen saturations and sleep continuity.
~________________________________________"
16230811|NCT01156116|Drug|Placebo|oral placebo tablet
16230812|NCT01156103|Behavioral|America SCORES, Bay Area|After-school program promoting physical activity via soccer 3 days/week
16230813|NCT01156077|Drug|TR-701 FA|Oral TR-701 FA 200 mg will be given as a single oral dose
16230814|NCT01156077|Drug|TR-701 FA|TR-701 FA 200 mg will be given as a single 60 minute IV infusion in 250 cc saline
16230912|NCT01155362|Biological|Human Placenta-Derived Cells PDA001 Intravenous Infusion|
16230816|NCT01156064|Device|Narrow Band Imaging/Auto Fluorescence Imaging (Olympus)|NBI/AFI endoscope offers an alternative light source involve NBI and AFI to view digestive mucosa in real time.
16230817|NCT01156051|Drug|Guanfacine extended-release tablets|Guanfacine extended-release tablets will be started at 1mg and then increased at weekly intervals to 2mg, 3mg, or 4mg as needed and as tolerated
16230818|NCT01156051|Drug|Placebo comparator|Placebo tablets identical to the experimental arm guanfacine extended-release tablets 1mg, 2mg, 3mg, 4mg, but without the active ingredient (guanfacine).
16230819|NCT01156038|Device|Atopy patch test with food allergen|Atopy patches used with food lyophilized allergen and commercial allergen were placed on back of subjects for 48 hrs then atopy patches were taken off. Subjects should return to evaluate reaction one day later(72 hrs after applying atopy patch test)
16230820|NCT01156025|Drug|GV550|Ganciclovir 1.5 mg/g, 1 drop 10 times daily at D0 and D1 and 1 drop 5 times daily from D2 to D9 + additionnal treatment (Hyabak® eye drops: 5 times daily from D10 to D30)
16230821|NCT01156025|Drug|placebo|1 drop 10 times daily at D0 and D1 and 1 drop 5 times daily from D2 to D9 + additionnal treatment (Hyabak® eye drops: 5 times daily from D10 to D30)
16230822|NCT01156012|Drug|T2345|One drop of T2345
16230823|NCT01156012|Drug|Prostaglandin|One drop
16230824|NCT01155999|Drug|T1225|one drop twice daily (morning and evening) in each eye from Day 0 to Day 2
16230825|NCT01155999|Drug|Tobramycin|1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6
16230826|NCT01155986|Drug|Lidocaine 5% medicated plaster|Topical hydrogel plaster (700mg lidocaine)
16230827|NCT01155986|Drug|Placebo topical plaster|Topical hydrogel plaster
16230828|NCT01155973|Behavioral|EDUCORE intervention|Direct exhibition of their cardiovascular risk with SCORE, visual images and documentation to the patients
16230829|NCT01155973|Other|Control group|SCORE oral information and counseling as standard practice care
16230830|NCT01155960|Drug|Anastrozole|Anastrozole Tablets 1 mg of Dr.Reddy's Laboratories Limited
16230831|NCT01155947|Drug|Anastrozole|Anastrozole Tablets 1 mg of Dr.Reddy's Laboratories Limited
16230832|NCT01155934|Drug|Risperidone Orally Disintegrating Tablets|Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited
16230833|NCT01155921|Drug|Risperidone Orally Disintegrating Tablets|Risperidone Orally Disintegrating Tablets 1 mg of Dr.Reddy's Laboratories Limited
16230834|NCT01155908|Drug|Amlodipine Besylate / Benazepril Hydrochloride|10 mg Amlodipine Besylate / 20 mg Benazepril Hydrochloride Capsules
16230835|NCT01155895|Drug|Amlodipine Besylate / Benazepril Hydrochloride|10 mg Amlodipine Besylate / 20 mg Benazepril Hydrochloride Capsules
16230836|NCT01155882|Procedure|Whipple at the Splenic Artery (WATSA)|
16230837|NCT01155869|Drug|Depot naltrexone|Depot naltrexone 380 mg. IM monthly
16230838|NCT01155869|Drug|Oral Naltrexone|Naltrexone 50 mg tablet PO daily
16230839|NCT01155856|Other|Telemedical admission and treatment in the patients´ own homes instead of conventional admission and treatment at the hospital|For this study a telemedical platform has been developed on which it is possible to treat patients in their own homes. The platform consists of a videoconference part that allows the patients to make contact to qualified medical staff and a technology part that can transfer vital indicators of the patients health condition (lung function, oxygen saturation, pulse etc.)175 patients will be included with an expected drop-out of 20 % or 35 patients. The patients will be equally recruited from two hospitals (Frederiksberg and Herlev Hospital). All patients must have an exacerbation in their COPD that requires hospitalization to be included in this study. Each patient participate in the study for 6 months after discharge with follow-up at 1, 3 and 6 months.
16230840|NCT01155817|Drug|Nilotinib|200, 400, 800, oral
16230841|NCT01155804|Behavioral|preparation of the delivery|Pregnant nulliparous women allocated to the non-interventional group will follow the routine pre-natal care. The participants of the study group will receive routine attention at the pre-natal care service and will also participate in the program of physical and educational after each routine pre-natal consultation. These activities will be organize as follow: 30 minutes of physical exercise for the prevention of pain and discomfort that may occur during pregnancy, preparation of the perineal muscles for delivery and prevention of urinary incontinence, 15 minutes for relaxation and 30 minutes for group discussion to respond to doubts that women may have and issues such as: change in posture during pregnancy and prevention of pain and discomfort; role of the perineal muscles during pregnancy, delivery and puerperium, physiology of delivery, non-pharmacological way for pain relief and breathing control during contractions of labor and delivery.
16230842|NCT01155791|Drug|Docetaxel|IV 75 mg/m2
16230843|NCT01155791|Drug|Biosyn|IV dosage varies
16230844|NCT01155791|Drug|Prednisone|5mg, orally
16230845|NCT01155778|Biological|Recombinant human heparan N-sulfatase (rhHNS)|
16230846|NCT01155765|Drug|Prasugrel|Prasugrel 10 mg/day for 15 days
16230847|NCT01155765|Drug|Clopidogrel|Clopidogrel 150 mg/day for 15 days
16230848|NCT01155752|Drug|Pulmozyme single use ampule|• Each Pulmozyme single use ampule delivers 2.5 mL (2.5 mg) of the sterile solution to the nebulizer bowl. The aqueous solution contains 1.0 mg/mL dornase alfa, 0.15 mg/mL calcium chloride dihydrate, and 8.77 mg/mL sodium chloride.
16230849|NCT01155752|Drug|placebo|identical placebo
16230850|NCT01155726|Device|Nelfilcon A contact lens|Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses inserted and removed by participant.
16230851|NCT01155726|Device|Nelfilcon A contact lens with comfort additive (DACP), unmasked|Commercially marketed, soft, hydrogel contact lens with comfort additive for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses and removed inserted by participant.
16230852|NCT01155726|Device|Nelfilcon A contact lens with comfort additive (DACP), masked|Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and packaging not visible to participant. Lenses inserted and removed by the investigator.
16230853|NCT01155726|Device|Nelfilcon A contact lens with comfort additive (DACP), partially masked|Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Lens name and manufacturer on blister pack label concealed from participant. Lenses inserted and removed by the participant.
16230913|NCT01155362|Drug|Vehice Control|
16230854|NCT01155726|Device|Etafilcon A contact lens|Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses inserted and removed by participant.
16230855|NCT01155726|Device|Etafilcon A contact lens with comfort additive (1DAVM), unmasked|Commercially marketed, soft, hydrogel contact lens with comfort additive for daily wear, daily disposable use. Blister pack label and lens packaging visible to participant. Lenses inserted and removed by participant.
16230856|NCT01155726|Device|Etafilcon A contact lens with comfort additive (1DAVM), masked|Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Blister pack label and packaging not visible to participant. Lenses inserted and removed by the investigator.
16230857|NCT01155726|Device|Etafilcon A contact lens with comfort additive (1DAVM), partially masked|Commercially marketed, soft, hydrogel contact lens for daily wear, daily disposable use. Lens name and manufacturer on blister pack label concealed from participant. Lenses inserted and removed by the participant.
16230858|NCT01155713|Drug|TKI258|
16230859|NCT01155700|Drug|omalizumab|
16230860|NCT01155661|Drug|LY2216684 (edivoxetine)|12 to 18 milligrams (mg), administered orally, once daily for 54 weeks, adjunctive to a selective serotonin reuptake inhibitor (SSRI)
16230861|NCT01155661|Drug|SSRI|Participants should have been on their SSRI for at least 6 weeks prior and were to continue on their stable dose throughout the study.
16230862|NCT01155648|Device|Chest wall compression plus increase of 10 cmH2O in inspiratory pressure during Pressure Support Ventilation for ten minutes in chest.|
16230863|NCT01155648|Device|Chest wall compression for ten minutes in chest|
16230864|NCT01155635|Drug|Carvedilol|Use of Carvedilol with any dose
16230865|NCT01155635|Drug|No Carvedilol|No use of Carvedilol
16230866|NCT01155622|Procedure|Endovascular Cooling|Infusion of <8°C cold saline followed by the implantation of the Icy 9.3F 38-cm catheter (ZOLL Medical Corporation, Chelmsford, MA) placed in the inferior vena cava through a femoral vein connected to the Thermogard XP Temperature Management System (ZOLL Medical Corporation). Cooling was set at a maximum rate with a target temperature of 32°C or 34°C according to randomization.
16230867|NCT01155609|Procedure|quality-of-life assessment|Ancillary studies
16230868|NCT01155609|Procedure|management of therapy complications|Discontinue supplement; treat symptomatically
16230869|NCT01155609|Dietary Supplement|L-lysine|Given PO
16230870|NCT01155596|Behavioral|negative pressure ventilator use|Body ventilators that assist ventilation by applying intermittent subatmospheric pressure around the thorax, abdomen, or airway and periodically expand the chest wall and inflate the lungs. They are relatively simple to operate and do not require tracheostomy. Chest cuirass is used in this study.
16230871|NCT01155583|Drug|azacitidine|Given by subcutaneous injection (SC)
16230872|NCT01155583|Drug|lenalidomide|Given orally
16230873|NCT01155583|Drug|dexamethasone|Given orally
16230874|NCT01155583|Other|DNA methylation analysis|Correlative studies
16230875|NCT01155583|Other|gene expression analysis|Correlative studies
16230876|NCT01155583|Other|bone marrow aspiration|Correlative studies
16230877|NCT01155583|Other|immunohistochemistry staining method|Correlative studies
16230878|NCT01155583|Other|reverse transcriptase-polymerase chain reaction|Correlative studies
16230879|NCT01155583|Other|flow cytometry|Correlative studies
16230880|NCT01155557|Device|Specific Strength Training|10 weeks of progressive specific strength training for neck and shoulder muscles.
16230881|NCT01155557|Behavioral|Lifestyle Counseling|10 weeks of counseling by nurse and physiotherapist in lifestyle changes.
16230882|NCT01155544|Behavioral|Behavioral Intervention|Preventing recurrence of substance use.
16230883|NCT01155531|Drug|Sertraline plus Telenzepine|oral sertraline tablets at 0, 50, 100, or 150/day plus oral telenzepine capsules at 0, 1, 2, or 3 mg/day for 7 days in each combination
16230884|NCT01155518|Drug|testosterone|intramuscular every 2 weeks
16230885|NCT01155518|Drug|clomiphene|thrice a week
16230886|NCT01155518|Drug|placebo|intramuscular saline injections every 2 weeks
16230887|NCT01155518|Drug|placebo|oral
16230888|NCT01155505|Drug|Lenalidomide (CC-5013)|CC-5013 given PO daily on D1-D14 every 21 days and Paclitaxel administered IV over 1 hour on d1 and 8 every 21 days until tumor progression or unacceptable toxicity
16230889|NCT01155479|Drug|Preladenant 2 mg tablet|Preladenant 2 mg oral tablet taken twice daily
16230890|NCT01155479|Drug|Preladenant 5 mg tablet|Preladenant 5 mg oral tablet taken twice daily
16230891|NCT01155479|Drug|Preladenant 10 mg tablet|Preladenant 10 mg oral tablet taken twice daily
16230892|NCT01155479|Drug|Rasagiline 1 mg capsule|Rasagiline 1 mg oral capsule taken once daily
16230893|NCT01155479|Drug|Placebo for Rasagiline 1 mg capsule|Placebo for rasagiline 1 mg oral capsule taken once daily
16230894|NCT01155479|Drug|Placebo for Preladenant|Placebo for preladenant 2 mg, 5 mg, or 10 mg oral tablet taken twice daily
16230895|NCT01155466|Drug|Preladenant 2 mg tablet|one 2 mg tablet orally twice daily
16230896|NCT01155466|Drug|Preladenant 5 mg tablet|one 5 mg tablet orally twice daily
16230897|NCT01155466|Drug|Preladenant 10 mg tablet|one 10 mg tablet orally twice daily
16230898|NCT01155466|Drug|Placebo to Preladenant Tablet|one tablet orally twice daily
16230899|NCT01155466|Drug|Rasagiline 1 mg capsule|one 1 mg capsule orally in AM
16230900|NCT01155466|Drug|Placebo to Rasagiline capsule|one capsule orally in AM
16230901|NCT01155453|Drug|BKM120|
16230902|NCT01155453|Drug|GSK1120212|
16230903|NCT01155440|Drug|Lidocaine|1% Lidocaine 1mg/kg/hr IV drip x 48hr
16230904|NCT01155440|Procedure|Thoracic epidural block|0.1% Epidural bupivacaine + Morphine 0.02 mg/ml drip via epidural x48 hr
16230905|NCT01155414|Other|Hydrolysate based infant formula|Infant formula ad lib
16230906|NCT01155414|Other|Investigational Infant Formula A|Investigational infant formula ad lib
16230907|NCT01155414|Other|Investigational Infant Formula B|Investigational infant formula ad lib
16230908|NCT01155388|Drug|Ferumoxytol|Experimental: Ferumoxytol
16230909|NCT01155388|Drug|Oral Iron|Active Comparator: Oral iron
16230910|NCT01155375|Drug|Ferumoxytol|Experimental: Ferumoxytol
16230911|NCT01155375|Drug|Oral Iron|Active Comparator: Oral iron
16230914|NCT01155349|Behavioral|InSight|A cognitive intervention designed to enhance speed of visual processing.
16230915|NCT01155349|Other|No contact-control group|No contact-control group.
16230916|NCT01155336|Drug|Lovaza®|Lovaza® is prescription grade EPA+DHA fish oil supplement.
16230917|NCT01155336|Drug|The placebo contained 1 gram of corn oil in each capsule.|Placebo Pill
16230918|NCT01155323|Device|etafilcon A|1-day soft contact lens
16230919|NCT01155323|Device|omafilcon A|1-day soft contact lens
16230920|NCT01155310|Drug|Helium/Oxygen 78%/22%|"The Helium/Oxygen mixture will be administered during NIV and NIV-free sessions for a maximum of 72 hours using study dedicated devices.
~Patients will then receive the Air/Oxygen mixture with usual devices."
16230921|NCT01155310|Drug|Air/Oxygen|"The Helium/Oxygen mixture will be administered during NIV and NIV-free sessions for a maximum of 72 hours using study dedicated devices.
~Patients will then receive the Air/Oxygen mixture with usual devices."
16230922|NCT01155297|Behavioral|Physical training|"The exercise program will be held three times a week and will have three stages: local and global stretching, aerobic exercise for 30 minutes ( with 50 and 60% of maximal heart rate) and strength training. The strength training will be done after assessment of one repetition maximum (1RM) and the prescription will be made with 50% load of 1RM, where the patient will hold three sets of 10-12 repetitions. Reassessments will be conducted monthly for readjustment of the charges. The duration of the training protocol will be six months.
~After completing this exercise program, patients will undergo a reassessment repeating the ET and reapplication of the SF-36, redone the collection of ADMA serum concentration."
16230923|NCT01155297|Behavioral|Stretching and metabolic exercises|At the control group will be performed stretching and metabolic exercises and will make the assessments and the reassessments after the end of the program.
16230924|NCT01155284|Drug|Sitagliptin and Lansoprazole|"Sitagliptin (dispensed as 50 mg capsules)and Lansoprazole(dispensed as 30 mg capsules) or matching placebo
~Subjects age 11-17 years at Visit 2 will take 1 capsule once daily
~Subjects age 18-45 years at Visit 2 will take 2 capsules once daily"
16230925|NCT01155284|Drug|Placebo|Sitagliptin 50mg and Lansoprazole 30 mg or matching placebo will be given daily for 12 months. Subjects age 11-17 at visit 2 will take 1 capsule daily; age 18-45 will take 2 capsules daily.
16230926|NCT01155271|Other|Rehabilitation|"12 weeks : 3 sessions per week (2 supervised sessions and 1 session at home)
~1 technical visit and 1 nursing visit every two months at home for the CPAP"
16230927|NCT01155258|Drug|temsirolimus|Given IV
16230928|NCT01155258|Drug|vinorelbine ditartrate|Given IV
16230929|NCT01155245|Drug|Forteo|Forteo pen
16230930|NCT01155232|Drug|Teriparatide|Forteo (teriparatide)pen daily for 24 months
16230931|NCT01155219|Drug|Geltim LP 1 mg/g|one drop in the conjunctival sac of each eye in the morning (84 days).
16230932|NCT01155219|Drug|Xalatan|one drop in the conjunctival sac of each eye in the morning (84 days).
16230933|NCT01155206|Drug|glucagon|glucagon 3ng/kg/min
16230934|NCT01155180|Drug|Leptin|Hormone - daily self injections for 6 months
16230935|NCT01155180|Drug|Placebo|Placebo
16230936|NCT01155167|Drug|Nitroglycerin and lidocaine|Topical Nitroglycerin and lidocaine
16230937|NCT01155167|Other|Placebo|Placebo
16230938|NCT01155154|Drug|cephalexin|500 mg (two 250 mg capsules) every 6 hours for 7 days
16230939|NCT01155154|Drug|clindamycin|300 mg of clindamycin (two 150 mg capsules) every 6 hours for 7 days
16230940|NCT01155154|Drug|placebo|Two placebo capsules every 6 hours for 7 days
16230941|NCT01155141|Drug|H.P. Acthar Gel|Patients were treated with 40 units subcutaneously (SC) weekly for 2 weeks, then dose increased to 80 units SC weekly for 2 weeks followed by 80 units SC twice weekly to complete 16 weeks of therapy.
16230942|NCT01155128|Behavioral|exercise aerobic|The intervention will consist of physical exercise sessions for approximately 60 minutes and two weekly sessions. The classes will consist of an initial part to exercises heating joint flexibility and lasting 10 minutes, a major part consists of aerobic exercise, lasting 20-30 minutes, and a piece of muscular endurance with exercises upper and lower limbs and abdomen, lasting 10-20 minutes. The intensity will be controlled through the Subjective Perception Scale Borg
16230943|NCT01155115|Procedure|Sputum Collection|Each study participant will be invited to expectorate sputum for culture, sensitivity, cytology and analysis of cytokine levels. Culture and sensitivity will be performed routinely at the beginning of a pulmonary exacerbation, as per standard of care, and will only be performed at subsequent visits if there is clinical indication. A volume of 5ml of sputum will be required at each visit for analysis. If the participant is unable to expectorate this volume of sputum, he/she will be invited to induce sputum instead as per standard protocols.
16230944|NCT01155115|Procedure|Pulmonary Function Testing|Participants will perform spirometry at each visit according to the American Thoracic Society and European Respiratory Society guidelines.
16230945|NCT01155115|Procedure|Exhaled Nitric Oxide|The investigators will measure exhaled Nitric Oxide (eNO) at each visit according to the American Thoracic Society and European Respiratory Society guidelines using a chemiluminescence analyzer. Briefly, single breath exhalation are performed in triplicate at flows of 30, 50, 100, 150, 200 and 250 ml/s and eNO is measured at the end of the exhalation. The higher the flow rate the more peripheral the airways that are being sampled.
16230946|NCT01155102|Drug|Anastrozole|1 mg tablet
16230947|NCT01155089|Drug|Anastrozole|1 mg tablet
16230948|NCT01155076|Dietary Supplement|Vitality Product|Proprietary blend of ginseng, cordyceps, and pomegranate taken twice a day for 8 weeks
16230949|NCT01155076|Dietary Supplement|Placebo|Placebo taken twice a day for 8 weeks
16230950|NCT01155063|Other|Aromasin (exemestane)|Aromasin (exemestane), tablets 25 mg, once a day
16230951|NCT01155050|Device|Tele-health Home Monitoring|Daily tele-health monitoring data will be collected from randomized participants.
16230952|NCT01155050|Behavioral|TrestleTree Telephone Coaching|Weekly or bi-weekly phone calls from TrestleTree health coaches with a focus on weight loss.
16230953|NCT01155050|Device|Tele-health Home Monitoring Plus Trestle Telephone Coaching|Daily collection of data through the tele-health home monitor and weekly or bi-weekly phone calls with a Trestletree Health Coach.
16230954|NCT01155037|Biological|Adjuvanted vaccine against H1N1 influenza virus (GSK)|Patients infected with HIV will receive 3.75 µg of an adjuvanted A H1N1 vaccine in two applications 21 days apart.
16230955|NCT01155037|Biological|Adjuvanted vaccine against H1N1 influenza virus (GSK)|Patients infected with HIV will receive 7.5 µg of an adjuvanted A H1N1 vaccine in two applications 21 days apart.
16230956|NCT01155037|Biological|Adjuvanted vaccine against H1N1 influenza virus (GSK)|Control group will receive 3.75 µg of an adjuvanted A H1N1 vaccine in one single application.
16230957|NCT01155024|Device|Traditional fabricated prosthetic socket|A prosthetic socket constructed utilizing traditional techniques. This intervention is a control and the basis for comparison.
16230958|NCT01155024|Device|Direct manufactured (DM) prosthetic socket|A prosthetic socket constructed from direct manufacturing technique. The socket will be tested under both diagnostic and definitive environments. Diagnostic testing will span several hours (4-6 hours) and definitive testing will span several months (3-6 months)
16230959|NCT01155011|Behavioral|Physical Activity|"MIPARC will focus on 3 physical activity goals:
~increasing walking behavior through gradually increasing step goals
~increasing attendance at available on-site and local aerobic, strength and flexibility classes, as well as prompting stair use,
~reducing sedentary behavior. Participants will monitor their steps with a pedometer, daily step logs and progress charts. All participants will have a gradually increasing fixed step goal for each week that will result in an total increase of 3000 steps after 3 months, which they will be supported to maintain for an additional 3 months."
16230960|NCT01155011|Behavioral|Group educational sessions|Every three weeks, participants will be required to attend a group education session, where researchers will teach behavior change strategies and allow participants to share their experiences and offer support to each other. The group sessions will follow a common format including: a group exercise (e.g. quiz), group discussion of use of behavior change strategies (e.g. overcoming barriers), and will end with a behavior change strategy instruction and goal setting component.
16230961|NCT01155011|Behavioral|Phone counseling call|"To support a tailored intervention delivery, participants will receive 4 individual phone calls (in weeks 2, 5, 8, and 11) from a trained health counselor. The phone call will follow the following format:
~health check
~step goal check
~barrier identification
~problem solving
~specific goals to achieve target step counts. Counselors will prompt participants to report any adverse events, illnesses, medication changes or counter indicative symptoms. The calls will cease during the second 3 months to allow participants to practice self help techniques while still supported by the group sessions and peer mentoring."
16230962|NCT01155011|Behavioral|Peer Mentoring|"Three peer mentors at each CCRC will be trained in intervention content and delivery, measurement support, and advocacy. The peer mentors will lead a group session once every three weeks for the 6 month intervention period and once a month for the following 6 months. The peer mentors will formulate their own ideas for these sessions but we will suggest they include group walks, group activities and trips to active locations, etc.
~The peers will help study staff to answer questions from participants and assist with study compliance and retention. They will also receive advocacy training from a non-profit advocacy organization to conduct walk audits of their CCRC and help mobilize participants to make changes to their community that will increase or improve the opportunities for physical activity."
16230963|NCT01155011|Behavioral|Policy Change|In order to increase the sustainability of the project, MIPARC will focus on addressing on-site policies and neighborhood factors that are barriers to physical activity. Peers and staff will conduct site inspections to identify these barriers (e.g. lack of facilities, limited opening hours, unsafe sidewalks, etc.) which will be prioritized and presented to CCRC management and community officials.
16230964|NCT01155011|Behavioral|Support|A binder of professionally prepared materials will be provided at the beginning of the intervention and are referred to by researchers in the group sessions and phone counseling calls. The materials provide important information to encourage knowledge, self efficacy and realistic expectations.
16230965|NCT01155011|Behavioral|Tailored environmental resources|Participants will be provided with a set of printed materials relating to the residential and neighborhood environment of their CCRC. A list of step counts for key indoor routes will be provided as well as safe walking route maps for the site an local neighborhood.
16230966|NCT01155011|Behavioral|Group educational sessions|Lectures will be delivered every three weeks to match the MIPARC intervention schedule. Sessions will include topics such as medications, foot care and nutrition. Physical activity will not e discussed in these sessions but participants will receive informational pamphlets on the benefits of physical activity.
16230967|NCT01155011|Behavioral|Health check phone call|For the first 3 months, control participants will also receive a health check phone call to match the individual attention paid to participants in the MIPARC sites.
16230968|NCT01155011|Behavioral|Pedometer|Participants will also keep the pedometer they wear during the baseline measurement week to satisfy any curiosity about the devices and the step entry criteria. They will be given instructions on its use but will not be taught the benefits of self-monitoring.
16230969|NCT01154985|Drug|Placebo capsule|3x Placebo capsules three times a day (TID) for 365 days
16230970|NCT01154985|Drug|EPA-E 300 mg capsule|2x 300 mg capsules + placebo capsule TID for 365 days
16230971|NCT01154985|Drug|EPA-E 300 mg capsule|3x 300 mg capsules TID for 365 days
16230972|NCT01154972|Procedure|Preoperative sentinel lymph node identification and marking|SLN is identified using gamma probe and ultrasound. Percutaneous wire placement carried out to mark SLN for subsequent surgical verification.
16230973|NCT01154959|Drug|Moxifloxacin, Isoniazid, Rifampicin Pyrazinamide, Ethambutol|Moxifloxacin (400mg), Isoniazid (300mg daily, 600mg thrice weekly), Rifampicin (450mg, and 600mg for patients weighing 60kg or more), Pyrazinamide (1500mg), Ethambutol (800mg)
16230974|NCT01154933|Drug|exenatide 5 mcg|exenatide 5 mcg
16230975|NCT01154933|Drug|exenatide 10 mcg|exenatide 10 mcg
16230976|NCT01154933|Drug|placebo|saline sq
16230977|NCT01154920|Drug|Paclitaxel|135 mg/m^2 weekly, Weeks 1 - 6
16230978|NCT01154920|Drug|Carboplatin|AUC of 2 weekly, Weeks 1 - 6
16230979|NCT01154920|Drug|Cetuximab|"PCC Arm: 400 mg/m^2 by vein over about 1-2 hours on Day 1; 250 mg/m^2 weeks 2 - 6.
~C-TPF Arm: 250 mg/m2 weeks 2, 4, 5, 7 and 8."
16230980|NCT01154920|Drug|Docetaxel|75 mg/m^2 by vein over 1 hour on Day 1 of each 21 day cycle for 3 cycles of induction therapy
16230981|NCT01154920|Drug|Cisplatin|100 mg/m^2 by vein over 1-3 hours on Day 1 of each 21 day cycle for 3 cycles of induction therapy
16230982|NCT01154920|Drug|Fluorouracil|700 mg/m^2 continuous infusion Days 1-4 on Day 1 of each 21 day cycle for 3 cycles of induction therapy
16231281|NCT01152736|Drug|Nicotine|2 mg Single-dose
16230983|NCT01154920|Radiation|Radiotherapy (RT)|Radiation about 2-4 weeks after induction therapy, Monday through Friday for about 7 weeks, or as recommended by the treating radiologist.
16230984|NCT01154920|Other|Chemotherapy|PCC group receives 6 and C-TPF group receives 3 chemotherapy treatment cycles. If receiving radiation + chemotherapy, weekly Cisplatin 40 mg/m^2 by vein over 1-3 hours or Carboplatin AUC 2 by vein over 1 hour beginning 2 to 3 weeks after conclusion of induction program.
16230985|NCT01154907|Drug|Praziquantel|One day, 40mg/kg standard mass Praziquantel as recommended by WHO and local authorities
16230986|NCT01154894|Other|Aravita including arachidonic acid and docosaheaenoic acid|Nine of 13 Participants were treated with 6 capsules of Aravita per day for 16-week trial, remaining 4 participants aged under 12 years received 3 capsules per day.
16230987|NCT01154881|Drug|insulin degludec|Insulin degludec (IDeg) injected s.c. (under the skin) once daily for 6 days in each treatment period. Each subject was randomly allocated to 2 out of 4 treatments.
16230988|NCT01154868|Procedure|Alveolar ridge augmentation|Under local anesthesia, full-thickness mucoperiosteal flaps will be elevated, followed by degranulation, and collection of all clinical measurements. Crestal and vertical releasing cuts will be performed using diamond-coated discs on the edentulous ridge in need of augmentation. A sequence of bone chisels and osteotomes will be used to split the alveolar ridge in half until a desirable width for implant placement is achieved. Healos® will then be inserted between both osseous plates. Fixation screws will be used as needed to stabilize the expanded alveolar ridge. Collagen barrier membranes (Ossix Plus) will be used to cover the osseous wound. Flaps will be approximated to achieve primary wound closure.
16230989|NCT01154855|Procedure|Prophylaxis ; Gross debridement for diseased patients|1 per patient at 2nd visit lasting approximately 1 hour.
16230990|NCT01154829|Drug|amisulpride|Individually dosed, according to symptoms, for a period of 6 weeks
16230991|NCT01154829|Drug|aripiprazole|Individually dosed, according to symptoms, for a period of 6 weeks
16230992|NCT01154816|Drug|Alisertib|Given orally
16230993|NCT01154816|Other|Laboratory Biomarker Analysis|Correlative studies
16230994|NCT01154816|Other|Pharmacological Study|Correlative studies
16230995|NCT01154803|Dietary Supplement|Ready to Use Therapeutic Food (RUTF)|1 sachet/day, 500 kcal and multi micronutrients (fortified high quality food(RUTF),for 2 weeks after an illness (malaria, diarrhoea, pneumonia)
16230996|NCT01154803|Dietary Supplement|Micronutrient Powder (MNP)|2 sachets / day for 14 days after an illness (diarrheoea, malaria, pneumonia)
16230997|NCT01154790|Drug|CG100649|6 subjects: study drug 2 subjects: placebo
16230998|NCT01154790|Drug|Placebo|6 subjects: study drug 2 subjects: placebo
16230999|NCT01154790|Drug|Naproxen|6 subjects: study drug 2 subjects: placebo
16231000|NCT01154777|Behavioral|Neurofeedback training|60 sessions of Neurofeedback on 6-18 year olds with Autism
16231001|NCT01154764|Drug|CG100649|I period: CG 100649 single dose 6 mg II period: Ketoconalzole + CG100649 at the same time washout period: 42 days
16231002|NCT01154764|Drug|CG100649 and ketoconazole|I period: ketoconazole 400 mg + CG100649 6 mg II period: CG 100649 single dose 6 mg washout period: 42 days
16231003|NCT01154751|Device|SUPERA Interwoven self-expanding nitinol stent|Insertion of stent at stenotic area
16231004|NCT01154738|Drug|Lidocaine|"bolus dose of lidocaine (1.5 mg.kg-1) followed by an infusion of lidocaine (2 mg.kg-1 h-1) until the end of anesthesia.
~start of the induction of anesthesia 10 minutes after the bolus dose of lidocaine"
16231005|NCT01154738|Drug|Placebo|"NaCl 9/00 (same volume as in the lidocaine group)
~start of the induction of anesthesia 10 minutes after the bolus dose of NaCl 9/00"
16231006|NCT01154725|Behavioral|Patient education and rehabilitation|Patients in the experimental group will receive specialized and optimized care by stoma care nurses. This includes one-on-one guiding during the hospitalization, guidance by telephone after discharge and participation in patient education 3 times after discharge.
16231007|NCT01154725|Behavioral|habitual patient education|habitual patient education
16231008|NCT01154712|Device|Real Deep TMS|Stimulation parameters : Dorso lateral prefrontal cortex,1HZ,600 pulses per session,15 sessions
16231009|NCT01154712|Device|Sham Deep TMS|Stimulation parameters : Dorso lateral prefrontal cortex,1HZ,600 pulses per session,15 sessions
16231010|NCT01154699|Device|Bilevel PAP (4 weeks)|Subjects will use bilevel PAP each night for 4 weeks. The pressure levels will be adjusted by the investigators to increase lung volumes during the night.
16231011|NCT01154699|Other|Usual Care (4 weeks)|Subjects will continue with their usual asthma care. Investigators will make no changes to their medications or other habits.
16231012|NCT01154699|Other|Washout Period (4 weeks)|Subjects will continue with their usual asthma care in between the Usual Care and Bilevel PAP periods. Investigators will make no changes to their medications or other habits.
16231013|NCT01154686|Behavioral|Cogmed|The Cogmed Working Memory Training Program will be used as the experimental program because of preliminary evidence indicating its effectiveness in enhancing WM and reducing behavioural symptoms of inattention/hyperactivity in children. This software-based training program was designed to improve WM abilities, particularly in children with ADHD or severe attention problems. Training is implemented with a software program (RoboMemo©). It includes a set of auditory verbal and visual-spatial WM tasks presented via computer. All tasks involve: maintenance of simultaneous mental representations of multiple stimuli, unique sequencing of stimulus order in each trial and progressive adaptation of difficulty level as a function of individual performance.
16231014|NCT01154673|Drug|raltegravir|Raltegravir 400 mg BID + Maraviroc 150mg BID in addition to standard HAART
16231015|NCT01154673|Drug|maraviroc|Raltegravir 400 mg BID + Maraviroc 150mg BID in addition to standard HAART
16231016|NCT01154673|Drug|emtricitabine 200mg /tenofovir 300mg|emtricitabine 200mg /tenofovir 300mg QD
16231017|NCT01154673|Drug|lopinavir 400 mg/ritonavir 100mg|lopinavir 400 mg/ritonavir 100mg BID
16231018|NCT01154660|Other|Tidal Volume|observation of IJV circumference and cross sectional area using ultrasonography by changing of tidal volume
16231019|NCT01154647|Drug|citalopram|intravenous
16231020|NCT01154647|Drug|1 ml 0.9 % NaCl|intravenous
16231021|NCT01154634|Drug|AZD2516, 5 mg|Capsule, oral
16231022|NCT01154634|Drug|AZD2516, 16 mg|Capsule, oral
16231023|NCT01154634|Drug|AZD2516, 40 mg|Capsule, oral
16231024|NCT01154634|Drug|Placebo|Capsule, oral
16231025|NCT01154621|Drug|AZD9742|Sterile solution, 620 mg (20 mg/mL) in 50 mL vial with a fill volume of 31 mL
16231026|NCT01154621|Drug|Placebo|Sterile 5% dextrose solution
16231027|NCT01154608|Drug|Creon|
16231028|NCT01154608|Other|No enzyme therapy|Current enzyme therapy of the patient is stopped during 7 days
16231029|NCT01154595|Dietary Supplement|Plumpy Doz(r) - Ready-to-Use Food|47g Plumpy Doz(r) per day per child
16231030|NCT01154595|Behavioral|Food-for-Training|Conditional family food supplementation (sugar, sorghum, beans, iodized salt, vegetable oil) 1800 kcal/person/day in function of attendance and participation in a sensitization program covering various themes on household, water and disease management, hygiene promotion, sanitation and dietary practices for children.
16231031|NCT01154582|Dietary Supplement|Egg snack|subject consume 4 cooked whole eggs, providing 380 kcal
16231032|NCT01154582|Dietary Supplement|Cottage cheese|Subjects consume 200 g of cottage cheese, providing 380 kcal
16231033|NCT01154569|Drug|Azithromycin|500 mg single dose
16231034|NCT01154530|Other|Chlorhexidine|Mouthwash with a 0,2 % chlorhexidine solution for 30 seconds
16231035|NCT01154504|Other|clinical treatment|The clinical treatment will be optimized to gold standard international heart failure treatment
16231036|NCT01154504|Procedure|ultrafiltration|The ultrafiltration procedure will be done on Intensive Care Unit with automatic machine and HF 1400 filter. The fluid will be removed until a increased of 10% in hematocrit or clinical improvement.
16231037|NCT01154504|Procedure|isovolumetric hemofiltration|The isovolumetric hemofiltration will be done in Intensive Care Unit for 8 hours, and will be permitted the diuretic use.The dose will be 35 ml/kg/hour and will e used automatic machine and MF1400 filter.Diuretic use will be maintained.
16231038|NCT01154491|Drug|Ferric carboxymaltose|"Ferinject®: Ferric carboxymaltose: 2 vials of 10 mL containing each 500 mg iron, diluted in 250 mL normal saline for injection. Study drug to be administered by infusion immediately after preparation.
~Placebo for erythropoietin: 1 mL normal saline for subcutaneous injection."
16231039|NCT01154491|Drug|Erythropoietin|Erythropoetin: 40,000 units subcutaneous (unique dose).
16231040|NCT01154491|Drug|Placebo|"Placebo for ferric carboxymaltose: 250 mL normal saline for intravenous administration.
~Placebo for erythropoietin: 1 mL normal saline for subcutaneous injection."
16231041|NCT01154478|Other|Diet rich in omega-3 fatty acids|fish at least 3 times per week, large leaf vegetables
16231042|NCT01154478|Other|Diet rich in polyphenols|extra virgin olive oil, green tea, berries,fruits rich in polyphenols, dark chocolate, decaffenated coffee
16231043|NCT01154478|Other|Control diet|low content of omega-3 fatty acids and polyphenols (low intake of fish, nuts and legumes,oil rich in monounsaturated fatty acids, vegetables and fruits poor in polyphenols)
16231044|NCT01154478|Other|diet rich in omega-3 and polyphenols|Fish at least 3 times x week,large leaf vegetables + extra virgin olive oil, green tea, berries,fruits rich in polyphenols, dark chocolate, decaffenated coffee
16231045|NCT01154465|Procedure|Central Venous Catheter Insertion|"The preparation of the CVC installation will follow the procedures for skin preparation of the operator, installation of sterile fields and local anaesthesia.
~The patients' skin disinfection before catheter insertion and care will follow the protocol:
~Clean the area of insertion of the catheter with a solution of 4% aqueous povidone foaming (Betadine Scrub).
~Rinse with sterile water and then drying.
~First application of 5% alcohol povidone-iodine (alcoholic Betadine) far beyond the area of insertion.
~Second application of 5% alcoholic povidone-iodine (alcoholic Betadine) by the operator after sterile draping.
~After sterilisation and puncture, the Seldinger technique is employed to insert the line: a blunt guidewire is passed through the needle, and the needle is then removed."
16231046|NCT01154465|Device|Ultrasound guidance|"The ultrasound probe will be isolated by a sterile protective plastic and the operator will mount a ramp on which the puncture syringe needle is placed.
~A sterile gel will be used in order to visualize the vein and directly puncture under ultrasound guidance following:
~- The anterior Boulanger's incision for the internal jugular vein When venous aspiration is obtained, the needle can easily be removed from the ramp and the syringe to mount the catheter following Seldinger's method."
16231047|NCT01154452|Drug|Gamma-Secretase Inhibitor RO4929097|Given PO
16231048|NCT01154452|Other|Laboratory Biomarker Analysis|Correlative studies
16231049|NCT01154452|Other|Pharmacological Study|Correlative studies
16231050|NCT01154452|Drug|Vismodegib|Given PO
16231051|NCT01154439|Drug|cytarabine|Remission induction therapy: by short i.v. infusion on days 1 and 7. Consolidation therapy: by continuous infusion on days 1-5.
16231052|NCT01154439|Drug|etoposide|Remission induction therapy: by short i.v. infusion, on days 1-7. Consolidation therapy: by short i.v. infusion, on days 1-5.
16231053|NCT01154439|Drug|everolimus|"Remission induction therapy: test dose once a day by mouth, on days 1-21 (21 days).
~Consolidation therapy: dose as defined by the cohort once a day by mouth, on days 1-10."
16231054|NCT01154439|Drug|idarubicin|Consolidation therapy: by short infusion i.c. on days 1, 3 and 5.
16231055|NCT01154439|Drug|mitoxantrone hydrochloride|Remission induction therapy: by short i.v. infusion on days 1, 3 and 5
16231056|NCT01154426|Other|Diagnostic Laboratory Biomarker Analysis|Correlative studies
16231057|NCT01154426|Drug|Gemcitabine Hydrochloride|Given IV
16231058|NCT01154426|Other|Pharmacological Study|Correlative studies
16231059|NCT01154426|Drug|Veliparib|Given orally
16231060|NCT01154413|Behavioral|Intensive education of the doctor/nursing team on the protocol|
16231061|NCT01154400|Dietary Supplement|Casein protein hydrolysates|15 g casein protein hydrolysates + 15 g maltodextrin
16231062|NCT01154400|Dietary Supplement|Whey protein hydrolysates|15 g whey protein isolate + 15 g maltodextrin
16231063|NCT01154400|Dietary Supplement|Casein protein hydrolysates + LEU|15 g casein protein hydrolysate + 2.1 g LEU (40% of EAA content) + 15 g maltodextrin
16231064|NCT01154400|Dietary Supplement|Whey protein hydrolysates + LEU|15 g whey protein isolate + 1.5 g LEU (40% of EAA content) + 15 g maltodextrion
16231065|NCT01154387|Drug|Anti-Thymocyte Globulin|1.5mg/kg IV on Day of Transplant and 1.0-1.5 mg/kg IV once daily for a minimum of 4.5mg/kg and a maximum of 7.5mg/kg total cumulative dose
16231066|NCT01154387|Drug|TOL101|Potential Therapeutic Dose (PTD)-A (0.28-56 mg to be determined in Phase 1/Part A ) IV once daily x 6-10 doses starting on Day of Transplant
16231282|NCT01152723|Drug|Nicotine|2 mg, Single Dose
16231067|NCT01154387|Drug|TOL101|Potential Therapeutic Dose (PTD)-B (0.28-56 mg to be determined in Phase 1/Part A ) IV once daily x 6-10 doses starting on Day of Transplant
16231068|NCT01154387|Drug|Steroids|IV methylprednisolone prior to first 3 doses of study drug; oral prednisone tapered to 5-10 mg over 6 months
16231069|NCT01154387|Drug|Tacrolimus|Oral administration started by 6 days post-transplantation and continued for 6 months
16231070|NCT01154387|Drug|Mycophenolate mofetil (MMF)|Oral administration started by Day 1 post-transplantation and continued for 6 months
16231071|NCT01154374|Drug|MEBO Wound Ointment|Topical application twice daily
16231072|NCT01154374|Procedure|Standard of Care (sterile saline moistened gauze)|
16231073|NCT01154361|Drug|Icatibant (subcutaneous) and plazebo (intravenous)|
16231074|NCT01154361|Drug|Cortisone + Clemastin (intravenous) and plazebo (subcutaneous)|
16231075|NCT01154348|Drug|S-707106|Tablet, taken once daily with morning meal
16231076|NCT01154348|Drug|Placebo|Placebo tablet, taken once daily with morning meal
16231077|NCT01154348|Drug|Metformin, S-707106 plus metformin|Metformin twice daily maintenance, S-707106 tablet taken once daily with morning meal with metformin dosed twice daily
16231078|NCT01154348|Drug|Metformin, placebo plus metformin|Metformin twice daily maintenance, placebo tablet taken once daily with morning meal with metformin twice daily
16231079|NCT01154335|Drug|OSI-906|Dose Level 1: 50 mg Twice a Day, cycle-28 days Dose Level 2: 100 mg Twice a Day, cycle-28 days Dose Level 2a: 100 mg Twice a Day, cycle-28 days
16231080|NCT01154335|Drug|Everolimus|Dose Level 1: 5mg Daily, cycle-28 days Dose Level 2: 10mg Daily, cycle-28 days Dose Level 2a: 5mg Daily, cycle-28 days
16231081|NCT01154322|Device|Pixi pediatric mask|The study mask is designed for use with PAP therapy to treat OSA in pediatric patients aged 2-7 years. The study mask is designed to be used in the hospital and the home environment. The study subject will use the device for up to 30 days while participating in the study.
16231082|NCT01154309|Behavioral|Group CBT for Depression and AOD Disorders|18 sessions of 2-hour group CBT
16231083|NCT01154296|Behavioral|RESPECT-2 Counseling|Specifically designed for use with the rapid HIV test, involves a brief (approximately 20-40 minute) counseling session which includes an orientation to the rapid testing procedure, an explanation of the testing window period, routes of HIV transmission and the meaning of test results, a personalized exploration of risk, the creation of a risk-reduction plan, identification of sources for support and referrals, and HIV test results.
16231084|NCT01154283|Device|Viasys® Healthcare, Pulmonetic Systems, lap-top ventilator (LTV machine)|Noninvasive positive airway pressure ventilation
16231085|NCT01154270|Radiation|carbon ion boost|8 fractions carbon ion (8 x 3 GyE C12) therapy followed by 25 fractions of IMRT corresponding to a total dose of approximately 74 GyE. Treatment duration is approximately 61/2-7 weeks
16231086|NCT01154257|Procedure|Cleaning of teeth with a toothbrush|This is a split mouth study where patients will have one side of their mouth randomised for teeth cleaning with a toothbrush. Cleaning will be twice daily from recruitment until day seven.
16231087|NCT01154257|Procedure|Cleaning of teeth with a foam swab|This is a split mouth study where patients will have one side of their mouth randomised for teeth cleaning with a foam swab. Cleaning will be twice daily from recruitment until day seven.
16231088|NCT01154244|Other|HOMA-IR|Blood sampling for HOMA-IR and HbA1C, fasting glucose, C-peptide, Lipid profile
16231089|NCT01154231|Drug|Nonacog Alfa (Genetical Recombination)|"Patients with hemophilia B (congenital blood coagulation factor IX deficiency) who are administered this drug.
~Patients with hemophilia B are either patients for whom treatment was already started with a blood coagulation factor IX product (Previously treated patients: hereinafter, PTPs) or patients who have no history of treatment with a blood coagulation factor IX product in the past and for whom treatment will be started with this drug for the first time (Previously untreated patients: hereinafter, PUPs).
~The definition of PUPs in this survey is Patients in whom the total number of days of administration of a blood coagulation factor IX product other than this drug before administration of this drug was 3 exposure days (actual number of days of administration: hereinafter, EDs) or less."
16231090|NCT01154218|Drug|crizotinib|"Treatment A (Reference 1): a 250 mg single dose of crizotinib administered in a fasted state as 1 × 50-mg IRT and 2 × 100-mg IRTs.
~Treatment B (Reference 2): a 250 mg single dose of crizotinib administered in a fasted state as 1 × 50-mg PIC and 2 × 100 mg PICs.
~Treatment C (Test for BE, Reference for Food Effect): a 250 mg single dose of crizotinib administered in a fasted state as 1 × 250-mg CIC.
~Treatment D (Test High Fat): a 250 mg single dose of crizotinib administered with a high-fat meal as 1 × 250-mg CIC"
16231091|NCT01154192|Drug|Dexamethasone|Each subject in each group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin. Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.
16231092|NCT01154192|Drug|recombinant human chorionic gonadotropin (r-hCG)|Each subject in each group will receive 1 mg of oral dexamethasone in the evening and return in the morning for an injection of 25ug of IV recombinant human chorionic gonadotropin (r-hCG). Subjects will also have blood drawn at times -0.5, 0, 0.5, and 24 hours after the injection of r-hCG for measurement of steroid hormones.
16231093|NCT01154179|Other|Hypocaloric feeding|This intervention group will be prescribed 60% of recommended (by Schofield) requirements.
16231094|NCT01154166|Drug|ReQuip PR|If subjects are still eligible at the end of the placebo run-in period they will be randomized (1:1) to receive once daily doses of ropinirole PR or identical appearing placebo tablets. Dosing will start at 2 mg ropinirole PR, or placebo equivalent. During the 24 week treatment phase, the subjects dose will be adjusted according to the recommended schedule to achieve symptomatic control. All subjects must be titrated to a minimum dose of 6 mg/day.
16231095|NCT01154166|Drug|Placebo|Placebo
16231096|NCT01154153|Drug|Placebo nasal spray|1 spray/nostril, once daily in the morning, for 8 to 24 days during the screening phase.
16231097|NCT01154153|Drug|Triamcinolone acetonide aqueous (TAA-AQ) nasal spray (NASACORT AQ)|"Treatment assignment was randomized with stratification by sex and age group (>=2 to <6, >=6 to <12 years old).
~For children who were >=2 to <6 years old, 1 spray/nostril (110 µg TAA-AQ), once daily in the morning, for 6 weeks, during the double-blind treatment phase.
~For children who were >=6 yrs to <12 years old, either 1 spray/nostril (110 µg TAA-AQ) or 2 sprays/nostril (220 µg TAA-AQ), once daily in the morning, for 6 weeks, during the double-blind treatment phase."
16231098|NCT01154153|Drug|Placebo nasal spray|"Treatment assignment was randomized with stratification by sex and age group (>=2 to <6, >=6 to <12 years old).
~For children who were >=2 to <6 years old, 1 spray/nostril, once daily in the morning, for 6 weeks, during the double-blind treatment phase.
~For children who were >= 6 yrs to <12 years old, either 1 spray/nostril or 2 sprays/nostril, once daily in the morning, for 6 weeks, during the double-blind treatment phase."
16231099|NCT01154153|Drug|Claritin® Syrup|Children's Claritin® Syrup [5 mg of loratadine per 5 mL] could be taken orally for the relief of AR symptoms throughout the study on an as needed basis, according to the Food and Drug Administration-approved manufacturer's label.
16231100|NCT01154140|Drug|treatment|crizotinib 250mg orally continuous twice daily dosing
16231101|NCT01154140|Drug|treatment|pemetrexed 500mg/m2 IV day 1 plus cisplatin 75mg/m2 IV day 1 every 21 days OR pemetrexed 500mg/m2 IV day 1 plus carboplatin AUC 5 or 6 day 1 every 21 days investigator's choice
16231102|NCT01154127|Drug|NVA237|50 μg via NEOHALER inhaler device single dose dry powder inhaler (SDDPI) once daily
16231103|NCT01154127|Drug|Placebo|Matching placebo via NEOHALER inhaler device single dose dry powder inhaler (SDDPI) once daily
16231104|NCT01154114|Drug|darapladib|darapladib 40 mg oral dose
16231105|NCT01154101|Drug|Placebo|For the placebo product, the SRT2104 drug substance will be replaced by microcrystalline cellulose (Avicel® PH 105) to match the SRT2104 investigational product.
16231106|NCT01154101|Drug|SRT2104|SRT2104 drug substance is a new chemical entity which is supplied as a fine, yellowish/amber powder. The SRT2104 investigational product is prepared by packing 250 mg of micronized SRT2104 powder with no additional additives into a size 00 opaque, hard gelatin capsule, packaged in dosing bottles containing a single daily dose.
16231107|NCT01154088|Biological|Mencevax ACWY|One dose, Subcutaneous injection
16231108|NCT01154088|Biological|GSK Biologicals' meningococcal serogroup A, C, W-135, Y tetanus toxoid conjugate investigational vaccine [GSK 134612]|One dose, Intramuscular injection
16231109|NCT01154062|Drug|Pazopanib|Pazopanib tablet
16231110|NCT01154049|Biological|sm14 antigen plus adjuvant GLA|Healthy adults will receive 3 doses of the vaccine, on days 0, 30 and 60.
16231111|NCT01154036|Drug|ezetimibe 10 mg|
16231112|NCT01154036|Drug|atorvastatin|
16231113|NCT01154036|Drug|Comparator: rosuvastatin|
16231114|NCT01154023|Behavioral|stimulus control therapy, sleep restriction therapy, multi-component treatment (stimulus control therapy, sleep restriction therapy)|Treatment was given weekly for 6 weeks. Sessions 1 - 4 were in a group format. Session 5 & 6 were delivered individually by phone.
16231115|NCT01154010|Device|PEMF|ActiPatch will be worn by patients over the eye with anterior uveitis for 8 hours/day for 7 days. Patients will also be treated with topical steroids.
16231116|NCT01154010|Device|PEMF Placebo|Patients wear the placebo device for 8 hours/day for 7 days over the eye being treated for anterior uveitis. Patients will also be treated with topical steroids.
16231117|NCT01153997|Drug|catridecacog|Single rFXIII dose (12 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.
16231118|NCT01153997|Drug|placebo|Single rFXIII placebo dose (12 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.
16231119|NCT01153997|Drug|catridecacog|Single rFXIII dose (35 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.
16231120|NCT01153997|Drug|placebo|Single rFXIII placebo dose (35 IU/kg). Administered via slow intravenous (i.v.) push at a rate not exceeding two mL per minute.
16231121|NCT01153984|Drug|Erlotinib|Erlotinib 150 mg oral doses will be administered daily.
16231122|NCT01153971|Drug|rituximab|1
16231123|NCT01153958|Drug|Colposeptine|Colposeptine will be administered transvaginally at a dose of 1 capsule every day for 12 consecutive days
16231124|NCT01153958|Drug|Metronidazole|Metronidazole will be administered orally at a dose of 400 mg twice a day for 7 days
16231125|NCT01153932|Drug|GSK2402968|Subcutaneous injection
16231126|NCT01153932|Drug|matched placebo|Subcutaneous injection
16231127|NCT01153919|Biological|romiplostim|Given subcutaneously
16231128|NCT01153919|Drug|ribavirin|Given orally
16231129|NCT01153919|Other|placebo|Given subcutaneously
16231130|NCT01153919|Biological|PEG-interferon alfa-2a|Given subcutaneously
16231131|NCT01153919|Other|laboratory biomarker analysis|Correlative studies
16231132|NCT01153906|Other|Data collection|New onset of cases for endpoints of interest in the targeted population will be identified from ambulatory and inpatient electronic administrative data and will be confirmed by blinded review of the medical record by an Endpoint Adjudication Committee (EAC) that will confirm the AID case and will assess whether the onset of disease falls within the observation period. Fibromyalgia and psoriasis, for which a high number of cases are expected, will be identified from the electronic administrative data only.
16231133|NCT01153893|Biological|Pneumococcal vaccine GSK1024850A|Intramuscular injection, 1 or 2 doses
16231134|NCT01153893|Biological|InfanrixTM|Intramuscular injection, 1dose
16231135|NCT01153880|Drug|Retapamulin|Prescription sales claim of retapamulin
16231136|NCT01153880|Drug|Co-prescription of retapamulin and topical mupirocin|Same day prescription sales claims for retapamulin and topical mupirocin
16231137|NCT01153867|Behavioral|Schema Focused Therapy|SFT is a novel treatment approach to chronic, lifelong problems that incorporates cognitive, behavioral, experiential and psychodynamic elements and techniques. In the present study participants will receive up to 75 individual sessions of SFT depending on the individual progress in therapy.
16231138|NCT01153854|Drug|Racecadotril|oral racecadotril (1.5mg./Kg./t.i.d. doe 5 days) in double blind assigned.
16231139|NCT01153854|Drug|Placebo groups|Placebo with feature color, appearance and tase similar to racecadotril t.i.d. for 5 days
16231140|NCT01153841|Biological|Synflorix™( GSK1024850A)|Intramuscular, 3 doses
16231141|NCT01153841|Biological|Infanrix hexa™|Intramuscular, 3 doses
16231142|NCT01153828|Drug|Retapamulin|Prescription for retapamulin
16231143|NCT01153828|Drug|Co-prescription of retapamulin and topical mupirocin|Same day prescriptions for retapamulin and topical mupirocin
16231144|NCT01153828|Drug|Co-prescription of retapamulin and topical fusidic acid|Same day prescription for retapamulin and fusidic acid.
16231512|NCT01150656|Genetic|western blotting|
16231145|NCT01153815|Drug|GSK1358820(Botulinum toxin type A)|"GSK1358820 (Botulinum Toxin Type A, also known as OnabotulinumtoxinA or Botox)"
16231146|NCT01153815|Drug|placebo|placebo
16231147|NCT01153802|Drug|GSK1360707 is a potent re-uptake inhibitor of the neurotransmitters dopamine, norepinephrine and serotonin|"This is an open label, adaptive design, daily dosing, non-randomized PET occupancy study in healthy adult males.A range of doses may be evaluated. The initial dose, given in the study as a single dose was 150mg GSK1360707. The remaining subjects will be dosed either as a single or split dose, as determined by the PET and tolerability data collected in the preceding subjects. The total dose will not exceed 150mg per day, the maximum total dose given in the FTIH study.If dosing is conducted as a single dose, the dose will be administered after the baseline scan, If a dosing is performed in a split dose manner, dosing will occur after the baseline scan, and up to 12 hours later. The time period between doses will be determined by emerging PET occupancy data.
~Subsequent doses, if any, will be chosen based on the observed scan results. No single dose, or total dose split over 2 dosing sessions, will exceed the maximum dose in the FTIH study."
16231148|NCT01153789|Procedure|orthoptic rehabilitation|Orthoptic rehabilitation: 12 sessions (2 sessions per week) At the end of a series of 12 sessions of orthoptic, the child will be examined and will again perform an static and dynamic oculomotor evaluation and control of postural balance.
16231149|NCT01153789|Other|Orthoptic diagnostic|postural, oculomotor and orthoptics tests
16231150|NCT01153776|Procedure|64-slice CT angiography|the sensitivity and specificity of 64-slice CT angiography for the detection of lesions at the ostia and proximal segments of the reimplanted coronary arteries
16231151|NCT01153763|Drug|GSK2118436|Subjects will receive 150 mg of GSK2118436 twice daily and continue on treatment until disease progression, death, or unacceptable adverse event.
16231152|NCT01153750|Drug|Glivec|
16231153|NCT01153737|Other|Manual therapy (MT)|Ten treatment sessions of 30 minutes of MT or TENS on alternate days were provided by primary care physical therapists. MT techniques: neuromuscular technique, postisometric stretching, spray and stretching and Jones technique.
16231154|NCT01153737|Other|TENS|Ten treatment sessions of 30 minutes of MT or TENS on alternate days were provided by primary care physical therapists. TENS electrode placement were: in the painful area, in the metamere or in the nerve´s pathway. It was applied at a frequency of 80 Hz, with ≤150 µs pulse duration and adjusted amplitude.
16231155|NCT01153724|Drug|BI 1744|10 mcg solution for oral inhalation
16231156|NCT01153724|Drug|Fluconazole|400 mg capsule
16231157|NCT01153711|Drug|BI 1744|10 mcg solution for oral inhalation
16231158|NCT01153711|Drug|BI 1744|10 mcg solution for oral inhalation
16231159|NCT01153711|Drug|Ketoconazole|400 mg tablet
16231160|NCT01153711|Drug|Ketoconazole|400 mg tablet
16231161|NCT01153698|Drug|dabigatran|anticoagulation
16231162|NCT01153685|Biological|Fluviral®|Intramuscular injection, one dose
16231163|NCT01153672|Drug|vorinostat|Given PO
16231164|NCT01153672|Other|laboratory biomarker analysis|Correlative studies
16231165|NCT01153672|Procedure|biopsy|Optional correlative studies
16231166|NCT01153672|Radiation|F-18 16 alpha-fluoroestradiol|Correlative studies
16231167|NCT01153672|Procedure|positron emission tomography|Correlative studies
16231168|NCT01153672|Drug|anastrozole|Given PO
16231169|NCT01153672|Drug|letrozole|Given PO
16231170|NCT01153672|Drug|exemestane|Given PO
16231171|NCT01153672|Genetic|gene expression analysis|Correlative studies
16231172|NCT01153659|Drug|E3810|RAB ER 50 mg capsule once per day on Days 1-5
16231173|NCT01153659|Drug|Aciphex (rabeprazole)|Aciphex (rabeprazole) 20 mg tablet once per day on Days 1-5
16231174|NCT01153659|Drug|Nexium (esomeprazole)|Nexium (esomeprazole) 40 mg capsule once per day on Days 1-5
16231175|NCT01153646|Genetic|pHIV7-shI-TAR-CCR5RZ treated CD4 cells|Single dose administration x 3 of genetically modified T-cells given at 3 infusions at 6 week intervals.
16231176|NCT01153633|Device|Prontosan Wound Irrigation Solution and Prontosan Wound Gel|"The treatment procedures (after a 1 week run-in) include:
~Cleansing the wound bed, at dressing change, with Prontosan® Wound Irrigation Solution or saline solution; a sterile gauze dressing impregnated with the Prontosan® or saline solution, depending on randomisation, will be placed on the wound in the form of a moist compress and removed after 15 minutes; the wound will be sparingly covered with Prontosan® Wound Gel or inactive gel, depending on randomisation
~Secondary dressing to be a semi occlusive dressing
~Secure the dressing to the wound with tubifast and short stretch compression system Dressings will be changed and the treatment procedure will be repeated every 3 days (+/- 1 day) when clinical, microbiological, planimetry and photographic assessments will be made. The randomised solution will also be used for removal of the dressing from the wound at the start of dressing change."
16231177|NCT01153633|Device|Normal Saline and Placebo Gel|"The treatment procedures (after a 1 week run-in) include:
~Cleansing the wound bed, at dressing change, with Prontosan® Wound Irrigation Solution or saline solution; a sterile gauze dressing impregnated with the Prontosan® or saline solution, depending on randomisation, will be placed on the wound in the form of a moist compress and removed after 15 minutes; the wound will be sparingly covered with Prontosan® Wound Gel or inactive gel, depending on randomisation
~Secondary dressing to be a semi occlusive dressing
~Secure the dressing to the wound with tubifast and short stretch compression system
~Dressings will be changed and the treatment procedure will be repeated every 3 days (+/- 1 day) when clinical, microbiological, planimetry and photographic assessments will be made. The randomised solution will also be used for removal of the dressing from the wound at the start of dressing change."
16231178|NCT01153620|Drug|Lavasept 0.04%|"Method of Administration A sterile compress will be saturated with Lavasept® 0.04% / Ringers' solution and placed on the wound.
~Dosage Lavasept® 0.04% 50 ml 50ml or as much needed to completely saturate the compress.
~Treatment Duration 60 minutes"
16231179|NCT01153620|Other|Ringer's Solution|"Method of Administration A sterile compress will be saturated with Lavasept® 0.04% / Ringers' solution and placed on the wound.
~Dosage Ringers' solution 50ml or as much needed to completely saturate the compress. Treatment Duration 60 minutes"
16231180|NCT01153607|Drug|BAY1006578|Alzheimer Disease patients: Single intravenous bolus injection of 250 MBq BAY1006578 on day one of the treatment period, PET
16231181|NCT01153607|Drug|BAY1006578|Healthy volunteers for brain imaging: Single intravenous bolus injection of 250 MBq BAY1006578 on day one of the treatment period, PET
16231182|NCT01153607|Drug|BAY1006578|Healthy volunteers for whole body imaging: Single intravenous bolus injection of 190 MBq BAY1006578, whole body PET for evaluation of effective dose, kinetics of BAY1006578 in blood
16231183|NCT01153594|Behavioral|Recovery Management Checkups (RMC)|After interviewers completed the quarterly research interview and determined participants' eligibility and need for early re-intervention, they transferred RMC participants who were eligible and in need to a Linkage Manager. Using motivational interviewing, the Linkage Manager: a) provided feedback to participants regarding their current substance use and related problems, b) discussed implications of managing addiction as a chronic condition, c) discussed treatment barriers and solutions, d) assessed and discussed level of motivation for treatment, e) scheduled treatment appointments, f) accompanied participants to treatment intake and stayed through the process, and g) implemented Engagement and Retention Protocol during the 14 days of treatment
16231184|NCT01153581|Drug|Ganirelix acetate|Ganirelix acetate: .25 ml/day by subcutaneous injection
16231185|NCT01153581|Drug|17β-Oestradiol|17 beta estradiol: 0.2 mg/day (patches)
16231186|NCT01153581|Drug|Progesterone|progesterone, 200 mg day-1 oral
16231187|NCT01153568|Dietary Supplement|Vitamin D 3|Patients will bew given a single capsule to take once daily
16231188|NCT01153568|Other|placebo|placebo tablets
16231189|NCT01153542|Drug|VX-770|In period 1, subjects will receive a single oral dose of desipramine on Day 1.
16231190|NCT01153542|Drug|VX-770|In period 2, subjects will receive 150 mg VX-770 q12h orally from the morning of Day 1 through the evening of Day 9. Subjects will receive 50 mg Desipramine as a single dose on Day 5 of period 2.
16231191|NCT01153503|Procedure|TAP block|"Group Intraoperative (at the end of surgery): Ketorolac 30 mg, IV + TAP block; TAP block
~First 24-h Postoperative: Ketorolac 30 mg q 6h + acetaminophen 650 mg q6h + IV-PCA morphine
~24-48-h Postoperative: Oral ibuprofen 800 mg q 8 h + hydrocodone/acetaminophen 5mg/500 mg 1-2 tablets q 6h, prn"
16231192|NCT01153490|Behavioral|Behavioral Intervention|Substance-related
16231193|NCT01153477|Behavioral|Telephone Monitoring and Counseling - Enhanced|Calls or in-person sessions, 1x weekly for first 8 weeks, then every other week up to a year. Step up session frequency if needed based on participants' ratio of protective and risk factors.
16231194|NCT01153464|Behavioral|Recovery Support Counseling|Telephone based recovery support provided by paraprofessionals at the City of Philadelphia's Behavioral Health Department. Calls are once weekly for 8 weeks, then step down to every other week for the remainder of the year of study participation. Call frequency can be increased as a result of a rise in risk factor/protective factor ratio.
16231195|NCT01153451|Other|Email Notification|BWH inpatient clinical information systems will automatically file all non-finalized chemistry, hematology, pathology, and radiology tests, as well as inpatient and ambulatory provider email addresses for all study patients discharged. This process will be initiated using a time stamp most proximate to actual discharge time. At midnight on every day, all tests filed at time of discharge will be updated if final results have become available. An email with all finalized and pending test results for each patient discharged will be sent to the inpatient and primary care provider at this time. For patients discharged with more than one pending test, subsequent email notification(s) will be sent out until all pending tests are finalized (no more than one email per day).
16231196|NCT01153425|Other|Virtual Bone Biopsy|MRI technology allowing generation of 3D images with considerably smaller voxel size than previous technology through the use of novel pulse sequences and advanced interpolation techniques.
16231197|NCT01153425|Drug|Teriparatide|Participants are clinically indicated for treatment.
16231198|NCT01153425|Drug|Zoledronic Acid|Participants are clinically indicated for treatment.
16231199|NCT01153412|Other|Osteopathic Manipulative Treatment|Osteopathic manipulation to determine balance and stability in elderly
16231200|NCT01153386|Drug|Treprostinil diethanolamine|Treprostinil diethanolamine sustained release oral tablets.
16231201|NCT01153373|Behavioral|Self-administered computerized assessment for tobacco, substance abuse, and alcohol use.|"All patients that give consent to participate in the study (participants) who are randomly assigned to the control condition will complete the computerized DARSSA for assessment purposes only."
16231202|NCT01153373|Behavioral|Self-Administered Computerized Assessment and Counseling for Tobacco, Alcohol, and Substance Abuse|All participants randomized to the DARSSA Intervention will be given instructions for how to complete the assessment. Once completed, the treating emergency physician will be expected to (1) give substance using patients the Patient Feedback Report, (2) recommend they review it carefully, and (3) encourage them to consider following up with the referrals.
16231203|NCT01153360|Drug|liothyronine sodium|liothyronine sodium 20ug, every 12hour (before anesthetic induction, total 4 times)
16231204|NCT01153360|Drug|placebo|vitamin B12
16231205|NCT01153347|Drug|TC-5214|Tablet, oral, twice daily for 8 weeks
16231206|NCT01153347|Drug|Placebo|Tablet, oral, twice daily for 8 weeks
16231207|NCT01153334|Drug|Early intensive rosuvastatin therapy (40 mg for 7days, starting in ER prior to primary PCI)|1. Test group: Early intensive rosuvastatin therapy - rosuvastatin 40 mg for pre-PCI loading and 7 days post PCI and 10 mg daily thereafter 2. Control group: Conventional statin therapy - Placebo for pre-PCI loading in ER and rosuvastatin 10 mg daily after primary PCI
16231208|NCT01153321|Drug|AZD2423|100mg Oral dose od
16231209|NCT01153321|Drug|AZD2423 Placebo|Oral dose od
16231210|NCT01153308|Other|Observational Study|This is an Observational study
16231211|NCT01153295|Procedure|Clinical diagnosis based on symptom criteria|The diagnosis is based on ROME III criteria, abscence of danger signals and FBC, CRP
16231212|NCT01153295|Procedure|Diagnosis of exclusion|The diagnosis is based on normal investigations involving endoscopy with biopsy, stool for ova and parasites, FBC, CRP, TSH, Ca, ALT, alanine aminotransferase; alkaline phosphatase, serum bilirubin, Screening for lactose and celiac sprue
16231213|NCT01153269|Drug|Lopinavir/Ritonavir (Kaletra)|3 capsules 2xdaily or 2 tablets 2xdaily Kaletra
16231214|NCT01153256|Drug|magnesium sulphate|The patients of group M receive 50 mg/kg of magnesium sulphate in 100 ml of isotonic saline over 10 min immediately before anaesthesia induction. After induction of anesthesia with alfentanil (10 μg/kg) and propofol (2 mg/kg), rocuronium 0.6 mg/kg is given over 5 s in a running infusion.
16231276|NCT01152775|Other|This group of patients will be exposed to multimedia|This group of patients will be exposed to multimedia
16231513|NCT01150656|Other|laboratory biomarker analysis|
16231215|NCT01153256|Drug|normal saline|Patients in the group R-0.6 receive the same volume of isotonic saline over the same period, and rocuronium 0.6 mg/kg is given after the induction of anesthesia with alfentanil (10 μg/kg) and propofol (2 mg/kg).
16231216|NCT01153256|Drug|normal saline|Patients in the group R-0.6 receive the same volume of isotonic saline over the same period, and rocuronium 0.9 mg/kg is given after the induction of anesthesia with alfentanil (10 μg/kg) and propofol (2 mg/kg).
16231217|NCT01153243|Drug|Ergocalciferol|"Active Comparator: Ergocalciferol
~The investigators will give intervention group 12 weeks of Vitamin D (ergocalciferol 50,000 units every week)"
16231218|NCT01153243|Drug|Placebo pill|The investigators will give control group 12 weeks of 1 placebo pill every week.
16231219|NCT01153217|Drug|Switch from tenofovir to abacavir|Switch from tenofovir to abacavir
16231220|NCT01153204|Behavioral|Group Psychotherapy|
16231221|NCT01153204|Other|Group Psychotherapy plus Sildenafil citrate|
16231222|NCT01153204|Drug|Sildenafil citrate|
16231223|NCT01153191|Procedure|Normal saline pressurized irrigation|same
16231224|NCT01153191|Drug|sub-q gentamicin|2mg/kg of gentamicin in 20 ml of sterile saline up to max dose of 120mg injected above the abdominal wall fascia- the length of the incision will be marked and injection made with intent being to evenly distribute the volume of injection in the subcutaneous tissues in immediate vicinity of and prior to the initial incision- analogous to the technique employed when using local anesthetic
16231225|NCT01153165|Drug|Citalopram|Participants will be commenced on Citalopram 20mgs daily. At week 4 participants will be assessed for response to treatment . If no response, dose of Citalopram will be increased to 40mgs for the remaining 8 weeks of the study. Patients who respond will remain on 20mgs for remaining 8 weeks.
16231226|NCT01153165|Drug|Placebo|Participants in the control group will receive a matched placebo. At week 4 participants will be assessed for response to treatment. If no response, dose of placebo will be increased to 40mgs for the remaining 8 weeks of the study. Patients who respond will remain on 20mgs for remaining 8 weeks.
16231227|NCT01153139|Device|Repetitive Transcranial Magnetic Stimulation (Theta Burst Stimulation, TBS)|intermittent TBS (iTBS) to the left DLPFC (600 stimuli, 80% resting motor threshold) continuous TBS (cTBS) to the right DLPFC (600 stimuli, 80% resting motor threshold)
16231228|NCT01153126|Behavioral|Comprehensive Health Enhancement Support System (CHESS.)|Half of the participating women will be randomly assigned to usual care and half will be offered a fully CHESS.
16231229|NCT01153113|Biological|hTERT mRNA DC|Subjects receive 1x107 cells per infusion administered ID at study week 1, 2, 3, 4, 5, 6 then receive 5x106 cells per infusion administered ID at study weeks 10, 14, 18, 22, 26, 30, 34, 38, 42, 46 and 50.
16231230|NCT01153113|Biological|hTERT mRNA DC|Subjects receive 1x107 cells per infusion administered ID at study week 1, 2, 3, 4, 5, 6 then receive 1x107 cells per infusion administered ID at study weeks 10, 14, 18, 22, 26, 30, 34, 38, 42, 46 and 50.
16231231|NCT01153100|Drug|Glargine|Glargine 0.25 units per kg body weight given every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy
16231232|NCT01153074|Device|Closure of bronchopleural fistula with Occlutech Figulla|Patients with bronchopleural fistulas will be submitted to a bronchoscopic procedure to deploy the cardiac septal defect occluder in the fistula traject.
16231233|NCT01153061|Device|Fistula closure with Gore Helex Septal Occluder|The occluder will be released at the tracheoesophageal fistoulous traject through endoscopic procedures
16231234|NCT01153061|Device|Gore Helex Septal Occluder|Fistula closure with endoscopic release of occluder in the fistula traject.
16231235|NCT01153048|Other|Intensification of education|The main objective is to assess impact of the establishment of involved patients (peer educators) network in Mali. Peer educators and persons targeted by the project will be recruited through Post-Test Club on diabetes (PTC). PTC will be a social support club that provides on going prevention counseling, education and support services to people who have diabetes. PTC represents an important link between patients, educators and general medical services. PTC will be defined as clubs, which are facilitated by well-trained peer educators, and will have 3 objectives: to provide social and emotional support to diabetic patients, to provide assistance in daily management and living with diabetes and to provide linkage to clinical care. To lead the sessions, in clubs, we will use a very innovative methodology for peer education: the learning nests method. To evaluate, we propose a classical randomized controlled experimental (RCT) design, with randomization at the person-level.
16231236|NCT01153035|Device|Radiofrequency Ablation|Breast conservation surgery followed by Radiofrequency Ablation of the cavity
16231237|NCT01153022|Other|joint mobilization techniques|In the experimental group, ankle joint mobilization was applied for five minutes, using grade II joint traction rhythmic oscillation (Mailland Scale) with the knee in 15° of flexion, subtalar in neutral and ankle in resting position (10º plantarflexion). During the control study, participants were placed under the same conditions as those of the experimental group but only the hands of the evaluator were placed in the foot, in the position of joint traction simulation.
16231238|NCT01153009|Drug|Vortioxetine|Encapsulated vortioxetine immediate release tablets
16231239|NCT01153009|Drug|Duloxetine|Overencapsulated duloxetine delayed-release capsules
16231240|NCT01153009|Drug|Placebo|Placebo-matching capsules
16231241|NCT01152996|Drug|Vortioxetine|Vortioxetine tablets
16231242|NCT01152983|Device|Rapid Ring|Rapid Ring is a ring-shaped device that encircles the distal phalanx of the middle finger and blocks the arterial blood to quickly and passively withdraw blood following a finger stick, and to reduce the pain of the lancet.
16231243|NCT01152957|Behavioral|CARIÑO Project|Care Attention Resources Information Nutrition & Optimism Project (CARIÑO) is a CHW intervention that will involve 4 or more (as required) home visits, 10 group sessions, and 10 follow-up phone calls per subject over a 12-month period. The primary outcome is lower HgA1C levels. The secondary outcomes are to lower LDL levels, and systolic and diastolic blood pressure, medication adherence and improved diet and exercise. CARIÑO Project will provide outreach support services to patients with poorly controlled diabetes, such as health education, lifestyle changes, home visits, follow-up phone calls, support groups, one on one counseling and coaching, and assistance with resource referrals.
16231244|NCT01152957|Behavioral|Enhanced Usual Care|Usual care plus 4 health education brochures
16231277|NCT01152775|Other|No Media|This group will not be exposed to multimedia
16231278|NCT01152762|Procedure|Standardized Respiratory Physiotherapy|Standardized Respiratory Physiotherapy during 6 months
16231245|NCT01152931|Drug|Amodiaquine + Artesunate|Intervention:the intervention in this group involves the use of standard antimalarial therapy for uncomplicated malaria based on WHO recommendation. artemisin based combination therapy will be used. amodiaquine will be administered via the oral route at a dose of 10mg/kg daily while artesunate will be administered orally at Artesunate 100mg stat, 50mg 8hrs later and 50mg bd x 3days
16231246|NCT01152931|Drug|Amodiaquine + Artesunate|Intervention:the intervention in this group involves the use of standard antimalarial therapy for uncomplicated malaria based on WHO recommendation. artemisinin based combination therapy will be used. amodiaquine will be administered via the oral route at a dose of 10mg/kg daily while artesunate will be administered orally at 100mg stat, 5omg 8hrs later and 50mg 12hrly for 3 days
16231247|NCT01152931|Drug|Lumefantrine + Artemether|Lumefantrine and artemether combination will be administered orally at a dose of 120/20mg daily for 3days
16231248|NCT01152931|Dietary Supplement|Artesunate + vitamin A|Artesunate will be administered orally at a dose of 100mg stat then 50 mg 8hrs later and 50mg 12hrly for 3days. vitamin A will be administered orally at a dose of 2000IU daily for 3 days
16231249|NCT01152931|Dietary Supplement|Artesunate + vitamin E|Artesunate will be administered orally at 100mg stat, then 50mg 8hrs after and 50mg 12hrly for 3 days. Vitamin E will be administered orally at 100mg dly for 3 days.
16231250|NCT01152931|Dietary Supplement|Artesunate + Zinc|Artesunate will be administered orally at a dose of 100mg stat then 50mg 8hrs after and 50mg 12mg 12hrly for 3 days. Zinc gluconate will be administered orally at a dose of 50mg dly for 4 days
16231251|NCT01152931|Dietary Supplement|Artesunate + selenium|Artesunate will be administered orally at 100mg stat and 8hrs later 50mg. then 50mg 12hrly for 3 days. selenium will be administered orally at a dose of 100ug dly for 4 days
16231252|NCT01152931|Dietary Supplement|Amodiaquine + vitamin A|Amodiaquine will be administered orally at a dose of 10mg/kg dly for 3days. Vitamin A will be administered orally dly at a dose of 2000IU for 4 days
16231253|NCT01152931|Dietary Supplement|Amodiaquine + Vitamin E|Amodiaquine will be administered orally at a dose of 10mg/kg dly for 3days. vitamin E will be administered orally at a dose 100mg daily for 4 days
16231254|NCT01152931|Dietary Supplement|Amodiaquine + Zinc|Amodiaquine will be administered orally at a dose of 10mg/kg dly for 3days. Zinc gluconate will be administered orally at a dose of 50mg dly for 4 days.
16231255|NCT01152931|Dietary Supplement|Amodiaquine + Selenium|Amodiaquine will be administered orally at a dose of 10mg/kg daily for 3days. Selenium will be administered orally at a dose of 100ug daily for 4 days if > 1year. 50ug daily for 4 days if < 1 year.
16231256|NCT01152931|Dietary Supplement|Artesunate + vitamin A + vitamin E|Tab Artesunate 50mg orally daily for 4 days. Vitamin A, 5000IU orally daily for 4days if < 1 year. 10,000 IU orally daily for 4 days if > 1 year.
16231257|NCT01152931|Dietary Supplement|Artesunate + Vitamin A + Zinc|Tab Artesunate 50 mg daily for 4 days. Vitamin A 5OOOIU daily for 4 days if < 1 year. 10,000IU daily for 4 days if > 1 year. All administered orally.
16231258|NCT01152931|Dietary Supplement|Artesunate + Vitamin A + Selenium|Tab Artesunate 50 mg orally, daily for 4 days. Vitamin A 5000IU orally daily for 4 days if < 1 year. 10,000IU orally daily for 4 days if > 1 year.
16231259|NCT01152931|Dietary Supplement|Artesunate + Vitamin E + Selenium|Tab Artesunate 50 mg orally daily for 4 days. Vitamin E 100 mg orally daily for 4 days. Tab selenium 100 ug orally daily for 4 days if > 1 year. 50 ug orally daily for 4 days if < 1 year.
16231260|NCT01152931|Dietary Supplement|Artesunate + Vitamin E + Zinc|Tab Artesunate administered orally at 50 mg daily for 4 days. Vitamin E 100 mg orally daily for 4 days. Tab Zinc 50 mg orally daily for 4 days if < 1 year. 25 mg orally daily for 4 days if > 1 year.
16231261|NCT01152918|Behavioral|Linkage-to-Care Component: Financial Incentive (FI)|Test sites assigned to this arm will provide coupons to all people who are found to be HIV-infected after testing and who are not already linked to HIV care. The coupons can be redeemed at a participating HIV care site for gift cards.
16231262|NCT01152918|Behavioral|Linkage-to-Care Component: Standard of Care (SOC)|Each person who receives an HIV positive test result, and is not currently in care, will be directed to HIV care sites using the site's SOC procedures.
16231263|NCT01152918|Behavioral|Viral Suppression Component: FI|HIV-infected participants who are receiving ART will be offered FIs upon the confirmation of each suppressed viral load measurement (less than 400 copies/mL).
16231264|NCT01152918|Behavioral|Viral Suppression Component: SOC|HIV-infected participants who are receiving ART will be offered support via the site's SOC procedures to attend HIV care site visits and remain adherent to their ART regimen in order to achieve and maintain viral load suppression.
16231265|NCT01152918|Behavioral|Prevention for Positives Component: Counseling and SOC|Participants will complete a computer-delivered counseling program that emphasizes HIV prevention strategies for HIV-infected people.
16231266|NCT01152918|Behavioral|Prevention for Positives Component: SOC|Participants will receive SOC from their HIV care site.
16231267|NCT01152879|Dietary Supplement|Home Parenteral Nutrition|Cancer Patients who are discharged on HPN will be monitored for quality of life, nutrition status, pain and nausea medication usage
16231268|NCT01152866|Drug|Choriogonadotropin alpha (r-hCG)|Choriogonadotropin alpha 250 μg was administered subcutaneously on the day following the last dose of follitropin alpha (Gonal-F).
16231269|NCT01152853|Drug|PF00299804|PF-00299804 will be given orally once daily at 45 mg daily. Patients will take study drug continuously, with cycles of 28 days.
16231270|NCT01152840|Drug|RAD001|"RAD001 10 mg po daily medication
~Treatments will be continued until any of the following events occur:
~progression of disease,
~the subject develops unacceptable toxicity,
~consent to participate in the study is withdrawn."
16231271|NCT01152827|Drug|RAD001|"RAD001 10 mg daily po medication.
~Treatments will be continued until any of the following events occur
~progression of disease
~the subject develops unacceptable toxicity
~consent to participate in the study is withdrawn"
16231272|NCT01152814|Biological|Seasonal flu vaccine|This phase II is performed as a multicenters study site in elderly subjects. Enrolled subjects received one single IM dose of trivalent subunit inactivated adjuvanted flu vaccine during the vaccination visit, according to the study protocol (follow-up period: till day 22)
16231273|NCT01152801|Drug|Everolimus (RAD001)|
16231274|NCT01152788|Drug|rIL-21|30 μg/kg IV Daily x 5, weeks 1, 3 and 5 every 8 weeks
16231275|NCT01152788|Drug|Dacarbazine|1000 mg/m2 IV Day 1, every 3 weeks
16231279|NCT01152749|Drug|Nicotine|Single-dose of new NRT product
16231283|NCT01152710|Drug|Capecitabine|Chemotherapy with capecitabine of 1650 mg/m2 daily dose will be administered orally, divided into two equal doses given 12 hours apart, during radiotherapy(45 Gy 1,8 Gy/fr), including weekends
16231284|NCT01152697|Drug|haloperidol decanoate|Drug is in in injectable form and will be administered approximately every four weeks through Week 25 of the study. A participant may continue on the drug after Week 25 at the discretion of his or her treating psychiatrist. Dosage is per package insert or at the discretion of the psychiatrist.
16231285|NCT01152697|Drug|haloperidol|Drug will be administered in oral form to participants not already taking oral haloperidol and then transitioned to the injectable version. Dosage and frequency is at the discretion of the psychiatrist.
16231286|NCT01152697|Behavioral|Customized Adherence Enhancement|CAE targets key areas relevant to non-adherent populations with schizophrenia or schizoaffective disorder: 1) inadequate or incorrect understanding of mental disorder; 2) lack of medication-taking routines; 3) poor communication with care providers; and 4) substance use which interferes with adherence and healthy behaviors that promote recovery. CAE is delivered based upon initial assessment of reasons for non-adherence and only those components of CAE that are determined to be indicated for that individual are delivered (psychoeducation, modified motivational interviewing, assistance with medication routines, coaching in communication with providers).
16231287|NCT01152671|Drug|Placebo|single oral dose
16231288|NCT01152671|Drug|RO5024048|single oral dose
16231289|NCT01152658|Biological|PRGF|enriched plasma fraction will be then injected to the trial group in sterile conditions under ultrasound control in the ssp gap
16231290|NCT01152658|Other|NACL|Nack 0.9 5 will be then injected to the control group group in sterile conditions under ultrasound control
16231291|NCT01152645|Drug|ARQ 197|Orally twice daily administration of ARQ 197
16231292|NCT01152632|Other|manual acupuncture|thirty minutes duration every time, five times per week for one course, a total four courses
16231293|NCT01152619|Drug|Placebo|Subcutaneous repeated dose
16231294|NCT01152619|Drug|RO4989991|Subcutaneous repeated dose
16231295|NCT01152606|Drug|trastuzumab [Herceptin]|There is no planned investigational product or a treatment regimen prescribed by this protocol. Decision about a treatment regimen will be made according to the local practice and in the best interest of individual patients.
16231296|NCT01152593|Drug|Mupirocin|Intranasal cream given to patient after confirmation of colonization
16231297|NCT01152580|Dietary Supplement|melatonin|3mg p.o. at bedtime daily
16231298|NCT01152580|Dietary Supplement|sugar pill|lactose p.o. at bedtime daily
16231299|NCT01152554|Drug|TC-5214|Tablet, oral, twice daily for 52 weeks
16231300|NCT01152554|Drug|Placebo|Tablet, oral, twice daily for 52 weeks
16231301|NCT01152541|Drug|Riboflavin/Dextran|Administration of riboflavin/dextran every 2 minutes for the duration of UV exposure
16231302|NCT01152541|Drug|Hypotonic Riboflavin|Administration of hypotonic riboflavin every 2 minutes for the duration of UV exposure.
16231303|NCT01152528|Device|VA-SENSE|The VA-SENSE contains a strip of pH indicator (color indicator) that is sensitive to the acidity level. A change in the color of the strip due to changes in the acidity level of vaginal secretions absorbed in the panty liner clearly indicates high probability of bacterial or parasitic vaginal infection. Any color change that results from contact with urine will disappear 10 minutes of drying out, and then the color of the indicator strip will fade back to the original color (yellow).
16231304|NCT01152515|Drug|Remifentanil|Control group : stopping of propofol and remifentanil infusion Remifentanil group : stopping of propofol and maintenance of remifentanil infusion
16231305|NCT01152489|Device|Device: Buzzy|"Buzzy, the vibrating cold pack, is held in place with a velcro strap or pressed by caretaker or nurse immediately prior and during immunizations. The vibration is activated and the device remains in place during the shot, moving locations if multiple shots are given. Distraction cards with pictures on one side and questions on the other are shown to the child while the caretaker asks the finding and seeking questions on the back."
16231306|NCT01152489|Device|Buzzy: sham device|The identical device without batteries or a cold pack is held in place proximal to the site with a velcro strap or pressed by parent or nurse immediately prior to immunizations. The device remains in place throughout the procedure, moving locations to complete multiple shots.
16231307|NCT01152476|Drug|remifentanil|General anesthesia is maintained witn sevoflurane and remifentanil.
16231308|NCT01152476|Drug|normal saline|General anesthesia is maintained with only sevoflurane and with normal saline instead of remifentanil
16231309|NCT01152463|Procedure|thoracic ultrasound|daily thoracic ultrasound evaluation of the chest
16231310|NCT01152450|Drug|Tiotropium 2.5 µg b.i.d|2.5 µg (two actuations of 1.25 µg) delivered via Respimat® inhaler
16231311|NCT01152450|Drug|Placebo|N/A (two actuations of placebo) delivered via Respimat® inhaler
16231312|NCT01152450|Drug|Tiotropium 5 µg q.d.|5 µg (two actuations of 2.5 µg) delivered via Respimat® inhaler
16231313|NCT01152437|Drug|BIBW 2992|Patients receive BIBW 2992 tablets once daily, and can reduce dose for adverse event management
16231314|NCT01152437|Drug|Cetuximab|Patients receive cetuximab intravenously, once a week, every week
16231315|NCT01152411|Other|Autologous bone marrow stem cells|Bone marrow stem cells; Single dose; Interventional fluoroscopy-guided injection into the renal artery.
16231316|NCT01152398|Biological|MVA-BN-HER2|experimental vaccine, subcutaneous injection q4weeks x6
16231317|NCT01152385|Drug|AZD1656|Oral tablet administered twice daily during 4 months
16231318|NCT01152385|Drug|Placebo|administered twice daily during 4 months
16231319|NCT01152372|Procedure|Insulin, glucose and staple isotopes|
16231320|NCT01152359|Behavioral|Choice|Participants are allowed to choose between a low-carbohydrate or a low-fat diet for weight loss after receiving information about these diets and their food preferences (Choice arm). Then they receive counseling on their chosen diet in a small group format. The low-carbohydrate diet limits carbohydrate intake to 20-40 grams/day initially. The low-fat diet restricts saturated fat to below 30% of daily calories and has a 500-1000 calorie deficit. Group sessions are every 2 weeks for 24 weeks then alternate with telephone calls every 2 weeks for 24 weeks. Phone calls focus on goal setting to maximize weight loss. Participants also receive counseling on behavioral techniques and physical activity. Participants in this arm have the option to switch diets at 12 weeks.
16231382|NCT01151800|Other|Using IVR to maintain ACS patients on best practice guidelines|
16231321|NCT01152359|Behavioral|Control|Participants are randomly assigned to (rather than getting to choose, as in the experimental arm) a low-carbohydrate or a low-fat diet for weight loss (Control arm). Then they receive counseling on their chosen diet in a small group format. The low-carbohydrate diet limits carbohydrate intake to 20-40 grams/day initially. The low-fat diet restricts saturated fat to below 30% of daily calories and has a 500-1000 calorie deficit. Group sessions are every 2 weeks for 24 weeks then alternate with telephone calls every 2 weeks for 24 weeks. Phone calls focus on goal setting to maximize weight loss. Participants also receive counseling on behavioral techniques and physical activity. Participants in this arm do not have the option to switch diets at 12 weeks.
16231322|NCT01152346|Drug|Azacitidine for Injection|75 mg/m2 sc injection on Day 1 of either cycle 1 or cycle 2 per randomization assignment
16231323|NCT01152346|Drug|Vidaza®|75 mg/m2 sc injection on Day 1 of either cycle 1 or cycle 2 per randomization assignment
16231324|NCT01152333|Drug|Exendin-(9-39) Acetate|Exendin (9-39) will be diluted in saline 0.9% and administered through IV infusion once for a maximum of 2.5 hours in length.
16231325|NCT01152333|Drug|Saline 0.9%|Saline will be administered through IV infusion once for a maximum of 2.5 hours in length
16231326|NCT01152320|Behavioral|Spirometry Fundamentals™ Training CD|MD-MA pairs randomized to the intervention arm of the study received 2 copies of the Spirometry Fundamentals™ CD. Included with the CDs was a letter explaining that each member of the MD-MA pair should view the CD at their convenience within the following 3 weeks. This letter included instructions on how to access the study website in order to complete an evaluation survey after viewing the CD.
16231327|NCT01152307|Behavioral|DVD/Booklet: Coping with Symptoms of Depression|DVD and booklet that provides information about treatment choices for depression symptoms
16231328|NCT01152294|Behavioral|DVD & Booklet called: Managing Menopause|DVD and booklet that provides information about treatment choices for menopause symptoms. Complete title: Managing Menopause: Choosing treatments for menopause symptoms
16231329|NCT01152281|Behavioral|Maximal Control|30 min video with stories of people with HIV. Content describes general health and emotional benefits of counseling.
16231330|NCT01152281|Behavioral|Instrumental and Empowering|Mix of Instrumental and empowering messages with stories of people living with HIV
16231331|NCT01152281|Behavioral|Minimal Control|Control messages to increase awareness of HIV risk
16231332|NCT01152281|Behavioral|Instrumental|Instrumental messages with stories of people living with HIV
16231333|NCT01152281|Behavioral|Empowering|Empowering messages with stories of people living with HIV
16231334|NCT01152255|Drug|MK6186|Panel A: 40 mg oral dose once daily for 7 days Panel B: 150 mg oral dose once daily for 7 days Panel C: Oral Dose <= 150 mg once daily for 7 days (dose level will be determined based on pharmacokinetic and pharmacodynamic results of panel A and B) Panel D: Oral Dose <= 150 mg once twice or three times daily for 7 days (dose level and dose frequency will be determined based on pharmacokinetic and pharmacodynamic results of panel A, B and C)
16231335|NCT01152255|Drug|Comparator: Placebo|Placebo tablets taken orally for seven day
16231336|NCT01152242|Drug|Isoglycemic Clamp|Isoglycemic Clamp, a procedure that includes IV infusion of short-acting Insulin (Part I) and glucose (Part I and 2)
16231337|NCT01152242|Drug|Comparator: insulin glargine|Insulin glargine at 0.4 U/kg
16231338|NCT01152216|Drug|Dimebon|20 mg orally three times daily
16231339|NCT01152203|Drug|Bendamustine|Starting dose of 70 mg/m^2 by vein on Days 1 and 2 of a 28 day cycle
16231340|NCT01152203|Drug|Bevacizumab|10 mg/kg by vein on Days 1 & 15 of every 28 day cycle
16231341|NCT01152190|Drug|Tadalafil|Administered orally, once daily for 8 weeks
16231342|NCT01152190|Drug|Placebo|Administered orally, once daily for 8 weeks
16231343|NCT01152177|Device|Electronic reminder letters|Electronic reminder letters if adherence is not obtained (up to four)
16231344|NCT01152164|Behavioral|questionnaires|Quality of life assessment using questionnaires EORTC QLQ C30 and 38 at baseline, one year and two years after the surgery of rectal cancer, treated with preoperative capecitabine based radiochemotherapy
16231345|NCT01152151|Device|Postal reminder letters|Postal reminder letters if adherence is not obtained (up to four)
16231346|NCT01152151|Device|Electronic reminder letters|Electronic reminder letters if adherence is not obtained (up to four)
16231347|NCT01152151|Device|Reminder letters|up to four reminder letters in september - december 2010
16231348|NCT01152138|Device|Open cells stent|Cobalt Chromium Stent with open cell design
16231349|NCT01152138|Device|Closed Cells Stent|Cobalt Chromium stent with closed cell design
16231350|NCT01152125|Other|Autologous bone marrow stem cells|Stem cells isolated from the patient's own bone marrow.
16231351|NCT01152112|Device|Myomectomy|Removal of fibroids and / or polyps
16231352|NCT01152099|Other|Compression Bandaging|"Group A or Control Group: ambulatory treatment is performed during one month. Specific exercises and prevention measures are taught. The tailor-made sleeve for lymphedema with gauntlet without protection at the edges and with extension to the shoulder is placed from the first four weeks of treatment. The sleeve is used during the whole day and a night interruption is allowed. Later the patient will continue domiciliary treatment realizing specific exercises for 30 minutes twice a day without fatigue carrying the lymphedema sleeve for at least 12 hours.
~If after three months of treatment a good response is not obtained an ambulatory treatment will be introduced again for one month,and this time the treatment corresponding to the group B or experimental will be applied."
16231353|NCT01152099|Other|Manual Lymph Drainage (MLD) and Compression Bandaging|"Specific exercises measures of prevention are taught. MLD is carried out followed by a daily multilayer bandage during the first four weeks. The tailor-made sleeve for lymphedema with gauntlet without protection at the edges and with extension to the shoulder is placed from the first four weeks of treatment. The sleeve is used during the whole day and a night interruption is allowed. Later the patient will continue domiciliary treatment realizing specific exercises for 30 minutes twice a day without fatigue carrying the lymphedema sleeve for at least 12 hours.
~If after three months of treatment a good response is not obtained an ambulatory treatment will be introduced again for one month, and this time the treatment corresponding to the group A or Control will be applied."
16231379|NCT01151839|Procedure|Neoadjuvant chemoradiation followed by surgery|Patient with squamous cell carcinoma of esophagus will be treated by neoadjuvant chemoradiation followed by surgery
16231380|NCT01151813|Drug|Varenicline|Varenicline, oral target dose of 1.0 mg BID, one week titration.
16231354|NCT01152086|Other|Mountain hiking in the Austrian and Bavarian Alps|"Regularly supervised physical exercise training program.
~Duration over all: 9 weeks; Frequency: 2 times per week; Duration one training-unit: 3 hours;
~Program:
~Endurance training (performed within 70-85% of the maximum heart rate)
~Short exercises before hiking (Mobilisation, Body and nature perception, ca. 5 min)
~Stretching after hiking (ca. 5 min)
~Short break at half-time (ca. 15 min)"
16231355|NCT01152073|Dietary Supplement|Placebo|Each subject will be expected to consume a twice daily drink of approximately 4 ounces per serving taken with the morning and evening meals for a total of 8 weeks. Each bottle will contain two servings.
16231356|NCT01152073|Dietary Supplement|Second Formulation|Each subject will be expected to consume a twice daily drink of approximately 4 ounces per serving taken with the morning and evening meals for a total of 8 weeks. Each bottle will contain two servings.
16231357|NCT01152073|Dietary Supplement|Third Formulation|Each subject will be expected to consume a twice daily drink of approximately 4 ounces per serving taken with the morning and evening meals for a total of 8 weeks. Each bottle will contain two servings.
16231358|NCT01152047|Drug|oxytocin|40mU/min as infusion of oxytocin
16231359|NCT01152034|Behavioral|psychoeducation group therapy|This program consists of 15 sessions of closed group, with each session lasting 120 minutes, each aims at improving four main issues: illness awareness, early detection of prodromal symptoms and recurrences, treatment adherence, and lifestyle regularity. The program will be in groups of 6-12, conducted by two experienced therapists. The structure of each session consists of 30-40 minutes talk on the topic of the day, followed by an exercise related to the issue and a discussion.
16231360|NCT01152021|Drug|Dexmedetomidine|An initial bolus of 2 mcg/kg of dexmedetomidine will be administered over 10 minutes. This bolus can be repeated up to 2 times if sedation conditions are not achieved. Once successful sedation has been achieved, a 1.5 mcg/kg/hr infusion is initiated until the MRI is complete.
16231361|NCT01152021|Drug|Propofol|An initial bolus of 1mg/kg of propofol will be administered over 1 minute. This bolus can be repeated up to 2 times if sedation conditions are not achieved. Once successful sedation has been achieved, a propofol infusion of 125 mcg/kg/min is initiated until the MRI is complete.
16231362|NCT01152008|Other|tourniquet ischemia|Recording of cutaneous blood flow on the forearm at rest and during cycle exercise 50W before and following tourniquet ischemia
16231363|NCT01151995|Other|Remote source document verification|Remote access to electronic medical records of the 5 participating sites
16231364|NCT01151995|Other|On-site source document verification|Study monitor will perform on-site source document verification during routine visit to the five participating sites
16231365|NCT01151982|Behavioral|Psychosocial Intervention|"The intervention we propose to test has 3 actives components. The first one is the fact of giving information to the GPs about the level and risk profile of depression of their patients. The second one is the transmission of this information from the GP to the patient. The third one is the interaction GP/Patient once both have the information about the risk profile of depression and the psychoeducational intervention that the GP will provide to the patient.
~We will develop psychoeducational booklet, DVDs and websites for patients included in the intervention group.
~The psychoeducative intervention will be tailored to each patient based on his/her profile, risk level and patients' risk factors.
~The GPs will receive a 20-hours training course in the intervention. Moreover, we will assume a communitarian view, considering the patient as an active agent for change (empowerment). That is, GPs and patients will work together in order to promote patients' resources."
16231366|NCT01151969|Behavioral|"New multicomponent 7H intervention"|The GPs in the intervention group will undertake an interactive workshop training session (15 hours) on the '7 hypotheses' (7H) intervention. In short, this intervention encourages GPs to select from a list of seven possible hypotheses for why the patient is a frequent attender: biological, psychological, social, family, cultural, administrative-organisational, or related to the doctor-patient relationship.
16231367|NCT01151943|Other|Transversus Abdominis Plane (TAP) Block|Bilateral injection of levobupivacaine (20 mL, 3.75 mg/mL)
16231368|NCT01151943|Other|Incisional Infiltration of Local Anesthetic|continuous administration of levobupivacaine (1,25 mg/mL,5 mL/h) during 48 hours.
16231369|NCT01151930|Drug|SCB01A|This is a companion study to the protocol SCB01A-01 intended to provide long-term continued administration to subjects that completed Protocol SCB01A-01 on a compassionate basis. It is an open-label, single-arm study of SCB01A in subjects who have completed 2 cycles of treatment under the SCB01A-01 protocol.
16231370|NCT01151904|Drug|brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution|COMBIGAN® (brimonidine 0.2%/timolol 0.5% fixed combination ophthalmic solution) administered as one drop in the morning and one drop in the evening in affected eye(s) for 12 weeks.
16231371|NCT01151904|Drug|latanoprost|Latanoprost administered in the affected eye(s) as prescribed by physician.
16231372|NCT01151878|Dietary Supplement|Glucomannan|1.26 g per sachet; 2 sachets per day for 4 weeks.
16231373|NCT01151878|Dietary Supplement|maltodextrin|prepared in sachets (1.3g); 2 sachets per day for 4 weeks
16231374|NCT01151865|Drug|Dexmedetomidine|"Dexmedetomidine will be administered intravenously as a maintenance infusion of 0.2 to 1.5 mcg/kg/hour, commencing at 0.5 mcg/kg/hour and titrated according to effect, for as long as deemed necessary by the treating physician. Specifically, the study medication may be (as recommended by the manufacturer) continued after extubation, and if discontinued may be restarted at any time up until ICU discharge. The clinician will have the option of using a loading dose of 1.0 mcg/kg IV over 20 minutes, as recommended by the manufacturer.
~Bedside nursing staff will adjust drug infusion rates as necessary, in consultation with the treating physician, aiming to achieve a Riker Sedation-Agitation Scale 20 score of 4."
16231375|NCT01151865|Drug|Saline placebo|An identical syringe containing only saline with no dexmedetomidine added will be supplied. Initial rate of infusion and subsequent adjustments will be the same as in the active comparator group.
16231376|NCT01151852|Drug|Imatinib|Patients will be randomly assigned to receive imatinib at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression, unacceptable toxicity, or withdrawal of consent.
16231377|NCT01151852|Drug|Placebo|Patients will be randomly assigned to receive placebo at a dose of 400mg/day, taken once daily with food, in the form of 100-mg tablets. The study medication will be administered until disease progression or withdrawal of consent.
16231378|NCT01151839|Procedure|Esophagectomy|Patient with squamous cell carcinoma of esophagus will be treated with surgery alone
16231383|NCT01151787|Drug|cyclobenzaprine hydrochloride|15mg daily for 3 months
16231384|NCT01151787|Drug|placebo|placebo
16231385|NCT01151761|Procedure|Stereotactic Body Radiotherapy|Standard of care
16231386|NCT01151761|Drug|Gemcitabine|100 mg/m2, IV
16231387|NCT01151761|Drug|Cisplatin|25 mg/m2, IV
16231388|NCT01151761|Drug|Carboplatin|AUC 2, based on Calvert formula, IV
16231389|NCT01151761|Drug|Capecitabine|1000 mg/m2, PO
16231390|NCT01151761|Drug|5FU|200 mg/m2
16231391|NCT01151761|Procedure|Liver transplantation|
16231392|NCT01151748|Procedure|Intra-arterial infusion of chemotherapy|
16231393|NCT01151735|Drug|C-1-esterase|1000 units of C-1-esterase inhibitor
16231394|NCT01151735|Drug|C-1-esterase|1500 units of C-1-esterase inhibitor
16231395|NCT01151735|Drug|placebo|placebo
16231396|NCT01151722|Procedure|bevacizumab injection|bevacizumab injection before vitrectomy
16231397|NCT01151722|Procedure|bevacizumab injection|bevacizumab injection after vitrectomy
16231398|NCT01151696|Drug|Atarax (Hydroxyzine)|One milligram per 10 kilogram, intramuscular use
16231399|NCT01151696|Drug|Placebo|Placebo
16231400|NCT01151683|Dietary Supplement|magnesium|Magnesium chelate, 300mg (2 capsules of 150mg) twice a day, per oral Total of 600mg per day
16231401|NCT01151683|Dietary Supplement|placebo|Two capsules of placebo per oral twice a day
16231402|NCT01151670|Drug|pioglitazone|Pioglitazone 22.5 mg daily before, during and after radiation therapy.
16231403|NCT01151670|Drug|Pioglitazone|Pioglitazone 45 mg by mouth daily before, during and after radiation therapy
16231404|NCT01151657|Dietary Supplement|Probiotics|Capsules with probiotics containing the strains : Lactobacillus paracasei ssp paracasei F19, Lactobacillus acidophilus La5 og Bifidobacterium Bb12. Dose/capsule : 2 x 109 - 10 x 109 CFU.
16231405|NCT01151657|Dietary Supplement|Placebo|Placebo capsules containing maltodextrin
16231406|NCT01151644|Biological|Anti-pandemic H1N1 influenza vaccine|inactivated, NON-adjuvanted pandemic H1N1 influenza vaccine (A/California/7/2009)
16231407|NCT01151631|Device|occipital nerve stimulation|Low occipital bilateral Quad Plus, midline to laterally directed, secured by titan anchors, connected to Versitrel. No trial stimulation. Suggested stimulation parameters: Pulse width: 450, Amplitude: protocol, Rate: 60
16231408|NCT01151618|Device|Respironics Synchrony ventilator (Non Invasive Ventilation)|Non Invasive Ventilation using forced oscillation technique (FOT)
16231409|NCT01151605|Drug|insulin|insulin to be infused at three different rates (2, 3.5 and 5 units/hour)
16231410|NCT01151605|Drug|insulin|insulin to be infused at three different rates (2, 3.5 and 5 units/hour)
16231411|NCT01151605|Drug|insulin|insulin to be infused at three different rates (2, 3.5 and 5 units/hour)
16231412|NCT01151592|Drug|Iron Sucrose|Iron Sucrose, 1000 mg cumulative dose to be administered per the US package insert.
16231413|NCT01151579|Drug|Levalbuterol|inhaled Levalbuterol 0.625 mg inhaled Levalbuterol 2.5 mg
16231414|NCT01151579|Drug|Albuterol|Nebulized albuterol 2.5mg
16231415|NCT01151553|Device|CRT Therapy|Screen for enrollment criteria, consented, echocardiogram and electrocardiogram performed, demographics reviewed, obtain blood sample, pre-operative QOL questionnaire and 6 minute hall walk
16231416|NCT01151540|Drug|Rufinamide|The target dosage is approximately 45 mg/kg/day, taken orally twice a day.
16231417|NCT01151514|Other|Nephrologist referral|Nephrologist specialty, renal replacement therapy
16231418|NCT01151501|Device|noninvasive positive pressure ventilation|Patients in whom the spontaneous breathing trial fail and in whom exclusion criteria are not present during this period were randomly allocated. Patients who are randomized to NPPV goup will be extubated and non-invasive ventilation (BiPAP Vision, Respironics Inc., Murrysville，Pennsylvania) will be delivered immediately after extubation using spontaneous/timed (S/T) mode. Expiratory positive airways pressure (PEEP) was initially set at 4 cmH2O and gradually increased to 6-8 cmH2O or more；and fraction of inspired oxygen (FiO2) was set to achieve pulse oximeter oxygen saturation (SpO2) >92% in cooperation with PEEP. On condition that tidal volume is no less than 6ml/kg，continuous positive airway pressure (CPAP) is permitted to apply，in which the adjusting procedures of CPAP and FiO2 is similar with PEEP and FiO2 in S/T mode. NPPV is terminated When patients can spontaneously breath oxygen provided by a Venturi device at FiO2≤0.35 for more than 24 hours with SpO2>92%.
16231419|NCT01151488|Other|Resistance Training|RT 3x/wk for 4 months
16231420|NCT01151449|Drug|gamma-secretase/Notch signalling pathway inhibitor RO4929097|Given orally
16231421|NCT01151449|Other|laboratory biomarker analysis|Correlative studies
16231422|NCT01151436|Device|hyaluronic acid dermal fillers|1 injection per indication and 1 touch-up injection if necessary
16231423|NCT01151423|Biological|Caplacizumab|"Subjects received a first intravenous (i.v.) bolus of 10 mg (filled at 5 mg/mL) caplacizumab via push injection within 6 hours to 15 minutes prior to the first PE on study. The first PE on study could either be the very first PE session for the current episode of aTTP (if the subject was randomized prior to the initiation of PE) or the second PE session (if the subject was randomized after a single PE session).
~The first PE on study was followed by subcutaneous (s.c.) administration of 10 mg study drug within 30 minutes after the end of the PE procedure.
~All subsequent study drug administrations were daily s.c. injections within 30 minutes after the end of the PE procedure (if applicable) or within 24 hours of the previous dose.
~Subjects received caplacizumab up to 30 days after the last PE session."
16231424|NCT01151423|Biological|Placebo|"Subjects received a first i.v. bolus of placebo via push injection within 6 hours to 15 minutes prior to the first PE on study. The first PE on study could either be the very first PE session for the current episode of aTTP (if the subject was randomized prior to the initiation of PE) or the second PE session (if the subject was randomized after a single PE session).
~The first PE on study was followed by s.c. administration of placebo within 30 minutes after the end of the PE procedure.
~All subsequent study drug administrations were daily s.c. injections within 30 minutes after the end of the PE procedure (if applicable) or within 24 hours of the previous dose.
~Subjects received placebo up to 30 days after the last PE session."
16231425|NCT01151410|Drug|Aliskiren|"Low weight patients: Starting dose 37.5 mg with optional titration to 75 and then 150 mg
~Mid weight patients: Starting dose 75 mg with optional titration to 150 and then 300 mg
~High weight patients: Starting dose 150 mg with optional titration to 300 and then 600 mg"
16231511|NCT01150656|Genetic|reverse transcriptase-polymerase chain reaction|
16231426|NCT01151410|Drug|Enalapril|"Low weight patients: Starting dose 2.5 mg with optional titration to 5 and then 10 mg
~Mid weight patients: Starting dose 5 mg with optional titration to 10 and then 20 mg
~High weight patients: Starting dose 10 mg with optional titration to 20 and then 40 mg"
16231427|NCT01151397|Drug|Peg + Vitamin D + Ribavirin|Peg+ Vitamin D+ Ribavirin for 3 months
16231428|NCT01151397|Drug|Peg + Ribavirin|Peg+ Ribavirin for 6 months
16231429|NCT01151384|Drug|LE-DT|Intravenous infusion, Upto 5 dose levels have been studied i.e. 50, 65, 85, 110 and 132 mg/m2, Every 3 weeks
16231430|NCT01151371|Device|narafilcon B contact lens|Silicone Hydrogel Daily Disposable Contact Lenses
16231431|NCT01151371|Device|nelfilcon A contact lens|Conventional Hydrogel Daily Disposable Contact Lenses
16231432|NCT01151371|Device|lotrafilcon B contact lens|Silicone Hydrogel Monthly Replacement Contact Lenses
16231433|NCT01151345|Drug|TILACEM|At 08:00 hours on day 1, CIF-BIOTEC personnel will start to administer the study drug. Each volunteer will receive a single dose of 60 mg of Diltiazem. The study drugs will be ingested with 250 mL of drinking water. Research Pharmacy personnel will inspect the volunteer's oropharynx to ensure that he/she has swallowed the tablet and record their observations in the corresponding forms.
16231434|NCT01151345|Drug|ANGIOTROFIN|At 08:00 hours on day 1, CIF-BIOTEC Pharmacy personnel will start to administer the study drug. Each volunteer will receive a single dose of 60 mg of Diltiazem. The study drugs will be ingested with 250 mL of drinking water. Research Pharmacy personnel will inspect the volunteer's oropharynx to ensure that he/she has swallowed the tablet and record their observations in the corresponding forms.
16231435|NCT01151319|Biological|ChAdV63.HIVconsv low dose.|Attenuated chimp adenovirus. 5x10^9 virus particles.
16231436|NCT01151319|Biological|ChAdV63.HIVconsv high dose.|Attenuated chimp adenovirus at 5x10^10 virus particles.
16231437|NCT01151319|Biological|pSG2.HIVconsv|DNA at 4mg per dose.
16231438|NCT01151319|Biological|MVA.HIVconsv|Attenuated poxvirus at 4x10^8 plaque forming units per dose.
16231439|NCT01151319|Other|Placebo|Phosphate buffered saline
16231440|NCT01151306|Drug|Simvastatin|Simvastatin 20mg once daily (in the evening) for 6 weeks
16231441|NCT01151306|Drug|Lactose tablet|One tablet taken each evening for 6 weeks
16231442|NCT01151280|Device|WallFlex Biliary Fully Covered Stent|Investigational device evaluated for the treatment for benign biliary strictures
16231443|NCT01151267|Other|Standard Anesthesia management for post surgical patients|The O2 flow on the anesthetic machine will be set at 15 L/min. Ventilatory assistance will be performed to maintain O2 saturation >97% and end tidal CO2 at 35-45mmHg.
16231444|NCT01151267|Device|Hypercarbic Spontaneous Hyperpnoea|Patient will be disconnected from the anesthetic circuit and connected to the resuscitation bag attached to the IH system. With O2 flow of 2 L/min patient will be gently ventilated until recovery of the spontaneous ventilation. After starting spontaneous ventilation basal O2 flow will be adjusted to keep ETCO2 in range of 50-60 mm Hg or minute ventilation of 15-17 L/min, whichever occurs first.
16231445|NCT01151254|Drug|Isoflurane/sevoflurane|Volatile for sedation in the CVICU while intubated
16231446|NCT01151254|Other|Propofol|Propofol for sedation in the CVICU
16231447|NCT01151241|Procedure|Elbow arthroscopy with infraclavicular nerve block and continuous local anesthetic infusion to day 3 post op.|Patients undergoing elbow arthroscopy surgery will receive standard anesthesia/analgesia, including infraclavicular nerve block and general anesthesia for surgery followed by infraclavicular catheter infusion of local anesthetic until day 3 after surgery.
16231448|NCT01151241|Other|Early Discharge|Patients will be discharged home on the first day after surgery, with infraclavicular catheter infusion of local anesthetic in place.
16231449|NCT01151241|Other|Normal Discharge|Patients will remain in hospital and be discharged per current discharge criteria, once the infraclavicular catheter has been removed on day 3 post op. Typical discharge occurs on day 3 or 4 post op.
16231450|NCT01151228|Other|Ultrasound examination followed by ingestion of Apple Juice prior to a second ultrasound procedure, followed by gastroscopic suctioning of stomach content.|Ultrasound scan of the stomach followed by ingestion of 0, 50, 100, 200, 300, or 400 mL of apple juice, followed by second ultrasound scan of the stomach, followed by gastroscopic suctioning of stomach content.
16231451|NCT01151215|Drug|AZD8931|Tablet, oral, bd
16231452|NCT01151215|Drug|anastrozole|Tablet, oral, od
16231453|NCT01151215|Drug|Placebo|Tablet, oral
16231454|NCT01151202|Drug|AG NPP709syrup|
16231455|NCT01151189|Biological|MVA85A/AERAS-485|Subjects received intradermal injection of MVA85A/AERAS-485 on Study Day 0, followed 6-9 months later by a booster injection of MVA85A/AERAS-485.
16231456|NCT01151189|Biological|Placebo|Subjects received an intradermal injection placebo on Study Day 0, followed 6-9 months later by a booster injection of placebo.
16231457|NCT01151176|Drug|Regular Insulin|1,8U Regular insulin/h from 180mg/dL of blood glucose increasing each hour according to capillary blood glucose. Between 100-150mg/dL keep infusion and bellow 100mg/dL stop infusion
16231458|NCT01151176|Drug|Regular Insulin|"Regular Insulin SC according to Blood Glucose(mg/dL) and Insulin Sensitive with usual dose describe and less 2U for sensitive and plus 2U for insulin resistant:
~Blood Glucose >141-180=4U ;181-220=6U; 221-260=8U; 261-300=10U;301-350=12U; 351-400=14U; > 400=16U"
16231459|NCT01150916|Procedure|BNP, SAAG, ascites total protein, echocardiography|diagnostic tests
16231460|NCT01150851|Other|caloric restriction|10 to 15% reduction in total daily calories (300 to 500 kcal reduction) from the usual daily energy consumption for 4 months duration
16231461|NCT01150851|Other|aerobic exercise|supervised physical activity for a maximum of 30-45 minutes, 3 times per week for 4 months duration
16231462|NCT01150838|Drug|propofol|Initial dose: Propofol 2 mg/kg, then dose changes separately based on the last subject in the same age group and sevo time range
16231463|NCT01150747|Drug|ceftriaxone|250mg IM once
16231464|NCT01150747|Drug|Azithromycin|1 gm once
16231465|NCT01149226|Drug|chloral hydrate|30 min before the induction of anesthesia, chloral hydrate (40 mg/kg) or placebo was administered to the children orally.
16231466|NCT01151137|Drug|Dronedarone|"Film-coated tablet
~Oral administration under fed conditions (during breakfast and dinner)"
16231467|NCT01151137|Drug|Placebo (for Dronedarone)|"film-coated tablet strictly identical in appearance
~Oral administration under fed conditions (during breakfast and dinner)"
16231468|NCT01151124|Biological|CTX0E03 neural stem cells|Single administration by surgical delivery to the damaged area of the brain
16231469|NCT01151111|Behavioral|Relaxation guided imagery|An individualized relaxation guided imagery session will be conducted. After the session patients will be given a CD with the RGI and asked to listen to it at home.
16231470|NCT01151098|Drug|Buprenorphine transdermal patch|Buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear
16231471|NCT01151085|Drug|Voriconazole|"Voriconazole Intravenous Solution 200 mg:
~Voriconazole is administered by intravenous drip infusion at the dose of 6 mg/kg twice daily on day 1 and 3 mg/kg or 4 mg/kg twice daily from day 2 onward in adults.
~Voriconazole Tablet 50 mg/ Voriconazole Tablet 200 mg:
~administration for an adult (weighing 40 kg or more) is voriconazole 300mg orally twice daily between meals for day 1 and then 150 mg or 200 mg twice daily between meals from day 2 onward.
~Depending on the symptoms or in cases where the effect is insufficient, the dosage may be increased.
~However, the maximum dose on day 1 must be 400 mg twice daily, and the maximum dose from day 2 onward must be 300 mg twice daily.
~In patients weighing less than 40 kg, voriconazole 150 mg shall be administered twice daily on day 1, and voriconazole 100 mg shall be administered twice daily from day 2 onward.
~Depending on the symptoms, the maintenance dose from day 2 onward may be increased to 150 mg twice daily."
16231472|NCT01151072|Drug|insulin degludec|Each subject was randomly allocated to five single dose administrations of NN1250 subcutaneously (under the skin) in the thigh, the abdomen (stomach) and the deltoid (shoulder), intramuscularly (into the muscle) in the thigh and intravenously (into the vein), respectively, on five separate dosing visits.
16231473|NCT01151059|Biological|Trivalent subunit inactivated flu vaccine, Formulation 2010-2011|This phase II is performed as a multicenter study site in non-elderly adult and elderly subjects. Enrolled subjects received one single IM dose of trivalent subunit inactivated flu vaccine during the vaccination visit, according to the study protocol (follow-up period: till day 22).
16231474|NCT01151046|Drug|MM-121|MM-121 (40mg/kg loading dose week 1, then 20 mg/kg weekly) administered over 60 minutes as an intravenous infusion once per week
16231475|NCT01151046|Drug|Placebo|Placebo (histidine solution) administered over 60 minutes as an intravenous infusion once per week and exemestane (25 mg) administered orally once per day
16231476|NCT01151046|Drug|Exemestane|Exemestane (25 mg) administered orally once per day
16231477|NCT01151033|Device|Drug Eluting Stent implantation|ProNOVA XR Drug Eluting Stent implantation
16231478|NCT01151020|Device|Zenith® TX2® Low Profile TAA Endovascular Graft|Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair
16231479|NCT01150994|Behavioral|Safety Assessment and Follow-up Telephone Intervention (SAFTI).|Mental health evaluation in ED, followed by Post-ED counseling
16231480|NCT01150981|Drug|Rosiglitazone|One 8mg capsule daily for 6 weeks.
16231481|NCT01150981|Drug|Placebo|One capsule daily for 6 weeks.
16231482|NCT01150968|Behavioral|End of life education|Residents will participate in one hour, case-based, interactive teaching sessions on end of life communication.
16231483|NCT01150955|Dietary Supplement|Resveratrol|500 mg three times a day for five weeks.
16231484|NCT01150955|Other|Placebo|Placebo (starch capsules) 500 mg three times a day for five weeks.
16231485|NCT01150942|Biological|JE vaccine|3 times, IM
16231486|NCT01150929|Device|P.F.C. Sigma knee arthroplasty|Randomization to either rotating platform or fixed bearing tibial plateau and polyethylene
16231487|NCT01150903|Other|no intervention|non-interventional study
16231488|NCT01150903|Other|no intervention|non-interventional study
16231489|NCT01150890|Drug|AMG 827 350 MG|350 mg AMG 827 IV (in the vein)
16231490|NCT01150890|Drug|AMG 827 210 MG|210 mg AMG 827 IV (in the vein)
16231491|NCT01150890|Drug|AMG 827 700 MG|700 mg AMG 827 IV (in the vein)
16231492|NCT01150890|Drug|Placebo|Placebo IV (in the vein)
16231493|NCT01150877|Drug|Vitamin D|We propose to study high-dose, oral vitamin D supplementation, raising serum 25-hydroxy-vitamin D (25(OH)D) concentrations to 200 -250 nmol/L, in metastatic colorectal cancer patients with safety, tolerability and survival as the main outcome measurements. The dose is not pre-set and will depend on the individual subjects' serum 25(OH)D concentration. Subjects will be supplemented for 16 months with a daily oral dose, followed by a 12 months follow-up period.
16231494|NCT01150864|Device|Airway Conditioning|Each Passive device will be changed daily. When using Active and Passive devices as well as Active-Passive devices the ventilatory circuit will be changed every 7 days.
16231495|NCT01150812|Drug|AZD8165|Oral suspension, 2 mg/mL and 20 mg/mL, single doses
16231496|NCT01150786|Dietary Supplement|Selenium Supplement|The patients in this arm took 200 microgram selenium yeast daily for 12 weeks.
16231497|NCT01150786|Other|placebo|The patients in this arm took one placebo capsule daily for 12 weeks.
16231498|NCT01150760|Drug|Alvimopan|At least 1 dose of alvimopan 12 mg during the hospitalization for bowel resection
16231499|NCT01150695|Other|Placebo|Normal saline will be administered to all subjects as a control and will be given at the same visit as the vaccine (Day 0).
16231500|NCT01150695|Biological|Undiluted Francisella tularensis live attenuated vaccine|Undiluted Francisella tularensis live attenuated vaccine [approximately 1x10^9 colony forming units (cfu)/mL] produced by Dynport Vaccine Company. Administered by scarification in the ulnar aspect of the volar surface (palm side) of the forearm midway between the wrist and the elbow.
16231501|NCT01150695|Biological|Undiluted Francisella tularensis live attenuated vaccine|Undiluted Francisella tularensis live attenuated vaccine (approximately 1x10^9 cfu/mL) in use by the United States Army Medical Research Institute of Infectious Diseases. Administered by scarification in the ulnar aspect of the volar surface (palm side) of the forearm midway between the wrist and the elbow.
16231502|NCT01150682|Genetic|RNA analysis|
16231503|NCT01150682|Genetic|reverse transcriptase-polymerase chain reaction|
16231504|NCT01150682|Other|enzyme-linked immunosorbent assay|
16231505|NCT01150682|Other|immunohistochemistry staining method|
16231506|NCT01150682|Other|laboratory biomarker analysis|
16231507|NCT01150669|Other|laboratory biomarker analysis|Samples are analyzed in laboratory studies
16231508|NCT01150656|Genetic|gene expression analysis|
16231509|NCT01150656|Genetic|microarray analysis|
16231510|NCT01150656|Genetic|protein expression analysis|
16231514|NCT01150656|Other|pharmacological study|
16231515|NCT01150643|Genetic|gene expression analysis|
16231516|NCT01150643|Genetic|microarray analysis|
16231517|NCT01150643|Genetic|polymerase chain reaction|
16231518|NCT01150643|Genetic|polymorphism analysis|
16231519|NCT01150643|Other|immunohistochemistry staining method|
16231520|NCT01150643|Other|laboratory biomarker analysis|
16231521|NCT01150630|Drug|capecitabine|1250 mg/mq/day per os for 14 days every 14 days for 6 months
16231522|NCT01150630|Drug|cisplatin|30 mg/mq every 14 days for 6 months
16231523|NCT01150630|Drug|epirubicin|30 mg/mq every 14 days for 6 months
16231524|NCT01150630|Drug|gemcitabine|ARM A: 1000 mg/mq for 3 weekly infusions every 4 weeks for 6 months ARM B and C: 800 mg/mq every 14 days for 6 months
16231525|NCT01150617|Drug|Insulin glargine plus insulin analogues|"Intensified insulin therapy: three administrations of regular insulin or short acting insulin analogues before meals combined with long-acting insulin analogue glargine in the evening. The treatment goal will be a fasting blood glucose level of 5.5 mmol/L (99 mg/dl) and a HbA1c<6.5% at the end of the follow-up.
~Standard care: treatment will be once-daily long-acting insulin and oral antidiabetic agents to achieve HbA1c levels of < 7.0% at the end of the follow-up."
16231526|NCT01150604|Behavioral|Self-help cognitive-behavioral online course|A self-help online course based on cognitive behavioral therapy for major depression.
16231527|NCT01150578|Drug|No intervention|No intervention
16231528|NCT01150565|Drug|LiRIS low dose and LiRIS high dose|Drug delivery system containing lidocaine; LiRIS (low or high dose) is inserted into bladder via cystoscopy on Day 1 and removed via cystoscopy on Day 14. Designed to release lidocaine over a 14 day period.
16231529|NCT01150539|Other|16-week exercise training program|The primary objective of the study is to investigate the effects of a 16-week exercise training program on insulin resistance and adiposity in overweight/obese women with PCOS.
16231530|NCT01150539|Other|Control Group without PCOS|A group of overweight/obese women without PCOS will be enrolled as a control group and will be studied only once at baseline to allow for comparisons between the two study populations.
16231531|NCT01150526|Dietary Supplement|CaHMB|CaHMB capsules with each capsule containing 0.8 g of HMB
16231532|NCT01150526|Dietary Supplement|HMB Free Acid Gel|HMB Free acid in a gel form with each dose supplying 0.8 g of HMB free acid
16231533|NCT01150526|Dietary Supplement|Placebo|Placebo capsules similar in size and color to the CaHMB capsules used in the study
16231534|NCT01150526|Dietary Supplement|Placebo Gel Dosage|A corn syrup based placebo with flavoring and taste similar to the HMB Free Acid Gel
16231535|NCT01150513|Drug|EC-T|four cycles of EC (epirubicin: 90 mg/m2; cyclophosphamide :600 mg/m2, day 1) followed by four cycles of T (docetaxel : 75 mg/m2 or paclitaxel 175 mg/m2, day 1)
16231536|NCT01150513|Drug|TP|six cycles of TP (docetaxel: 75 mg/m2 or paclitaxel 175 mg/m2 d1; carboplatin AUC=5, day 1)
16231537|NCT01150500|Device|MDT-4107 Zotarolimus-Eluting Coronary Stent|
16231538|NCT01150487|Procedure|bone marrow aspirations|A bone marrow aspiration from each hip bone of the patients.
16231539|NCT01150474|Drug|Belladonna and Opium Suppositories|Belladonna (16.2 mg) and opium (60 mg) suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
16231540|NCT01150474|Drug|Placebo Suppositories|Placebo suppositories administered rectally immediately following surgery and every 8 hours for 16 hours for a total of 3 doses.
16231541|NCT01150461|Drug|losartan|Losartan 50 mg b.i.d
16231542|NCT01150461|Drug|placebo|Placebo b.i.d.
16231543|NCT01150448|Drug|Paliperidone palmitate Treatment A|All patients will receive a single IM injection of 150mg eq of study drug on Day 1. Patients who tolerate 150mg eq will receive a 2nd IM injection of 150mg eq on Day 8 followed by 12 IM injections (1 every 4 weeks) of 150mg eq. All other patients will be assigned to Treatment B.
16231544|NCT01150448|Drug|Paliperidone palmitate Treatment B|Patients not tolerating Treatment A will receive a single IM injection of study drug 100mg eq at their next scheduled visit followed by injections (1 every 4 weeks) ranging from 50 to 150mg eq
16231545|NCT01150422|Other|Alternative follow-up|After mifepristone administration, women will be provided with a second semi-quantitative pregnancy test and a self-administered checklist. Women will be instructed to complete the checklist and perform the pregnancy test at home on an assigned data two weeks after mifepristone administration. On the assigned date, women will also be contacted by phone by the clinic staff. Women will be asked to confirm whether they completed the pregnancy test and checklist and asked to report on the results of both tests. Provider will review the women's responses to the checklist and confirm whether, based on the woman's responses, she should return for a follow up visit. During the follow-up phone call, women will also be asked about the satisfaction and acceptability of the alternative follow-up procedure.
16231546|NCT01150409|Drug|hydrocortisone|1) Hydrocortisone 50 mg IV every 12 hours x 4 doses (2 days), followed by Hydrocortisone 50 mg IV every 24 hours x 2 doses (2 days)
16231547|NCT01150409|Drug|Normal Saline|0.9% sodium chloride (equal volume to hydrocortisone) IV every 12 hours x 4 doses (2-days), followed by 0.9% sodium chloride (equal volume to hydrocortisone) IV every 24 hours x 2 doses (2-days)
16231548|NCT01150383|Other|Physical exercise training with supplemental oxygen|"Prior to the exercise training, an intervention-free control period with usual care is planned.
~Intervention group with oxygen supplementation: Endurance training (performed within 70-80% of the heart rate at the anaerobic threshold) as well as strength training will be performed with oxygen supplementation.
~After 6 weeks of intervention with oxygen supplementation, second intervention period will start with room air instead of oxygen supplementation (as described above)."
16231549|NCT01150383|Other|"Physical exercise training with room air supplementation"|"Prior to the exercise training, an intervention-free control period with usual care is planned.
~Intervention group with room air supplementation: Endurance training (performed within 70-80% of the heart rate at the anaerobic threshold) as well as strength training will be performed under normoxic conditions.
~After 6 weeks of intervention with room air, second intervention period will start with oxygen supplementation instead of room air (as described above)."
16231590|NCT01150058|Other|laboratory biomarker analysis|
16231591|NCT01150045|Drug|celecoxib|Patients receive celecoxib 400 mg administered by mouth, once daily.
16231687|NCT01149330|Drug|Adapalene-BPO Gel|Apply 1 gram of the investigational drug every night on whole face.
16231550|NCT01150370|Device|The PrePex a novel device for adult male circumcision|The PrePex System was designed to enable safe, effective, painless and bloodless male circumcision programs. The PrePex System includes a simple, disposable device that is easy to use and can be deployed by minimally trained healthcare professionals, without the need for sterile, hospital settings.
16231551|NCT01150357|Drug|Aliskiren (6.25/12.5/25 mg)|Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the low dose arm, participants used one or more of the 6.25 mg capsule (containing 2 minitablets) once daily to reach the body-weight stratified dose of aliskiren.
16231552|NCT01150357|Drug|Aliskiren (37.5/75/150 mg)|Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the medium dose arm, participants used one or more of the 37.5 mg capsule (containing 12 minitablets) once daily to reach the body- weight stratified dose of aliskiren.
16231553|NCT01150357|Drug|Aliskiren (150/300/600 mg)|Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the high dose arm, participants used one or more of the 150 mg capsule (containing 48 minitablets) once daily to reach the body- weight stratified dose of aliskiren.
16231554|NCT01150344|Drug|Malarone (atovaquone + proguanil combination)|4 X (250mg atovaquone + 100 mg proguanil) per os, once a day on 3 days as H0, H24 and H48.
16231555|NCT01150344|Drug|RIAMET (artemether + LUMEFANTRIN combination)|4 X (20mg artemether + 120 mg lumefantrine) per os twice a day on 3 days as H0, H8, H24, H36, H48 and H60
16231556|NCT01150331|Drug|Levetiracetam/Clonazepam|Association of two anti-epileptic drugs in first line
16231557|NCT01150331|Drug|Clonazepam/Placebo levetiracetam IV|Association of placebo to an active comparator (clonazepam)
16231558|NCT01150318|Drug|Administration of 131 iodine|100 mCi 131 iodine irradiation
16231559|NCT01150305|Biological|blood sample|Peripheral whole blood sample, 5 ml
16231560|NCT01150292|Dietary Supplement|First period DHA|400 mg DHA supplementation by day for 2 weeks during the first study period
16231561|NCT01150292|Dietary Supplement|Second period DHA|400 mg DHA supplementation by day for 2 weeks during the second study period
16231562|NCT01150266|Drug|Alteplase (tPA)|0.9mg/KG (maximum 90mg), 10% bolus over one minutes, remainder over one hour.
16231563|NCT01150253|Dietary Supplement|L. paracasei fermented milk|
16231564|NCT01150214|Procedure|DE-MRI|Using Delayed-Enhancement Magnetic Resonance Imaging (DE-MRI) to identify fibrotic and scarred cardiac tissue. DE-MRI is a non-invasive method of identifying the extent and the distribution of structural remodeling or fibrosis and scarring associated with atrial fibrillation both pre- and post-ablation.
16231565|NCT01150201|Drug|Aliskiren|For CKD treatment
16231566|NCT01150201|Drug|Losartan|Control
16231567|NCT01150188|Dietary Supplement|Amino acids|11 g amino acids two times per day for eight weeks
16231568|NCT01150188|Dietary Supplement|Placebo|Placebo of inert compounds, 11 g two times per day for eight weeks
16231569|NCT01150175|Procedure|Endomyocardial Injection of Autologous Bone Marrow Cells|Endomyocardial Injection of Autologous Bone Marrow Cells
16231570|NCT01150175|Procedure|Endomyocardial Injection of Plasma|Endomyocardial Injection of Plasma
16231571|NCT01150162|Drug|Rebamipide and Omeprazole|open label, oral route, Rebamipide, 100mg tablet t.i.d and Omeprazole 20 mg tablet B.I.D. for 8 weeks
16231572|NCT01150162|Drug|Omeprazole|open label,oral route, Omeprazole 20mg tablet, B. I.D.; alone, for 8 weeks
16231573|NCT01150149|Behavioral|No face touch|
16231574|NCT01150149|Device|Surgical face mask|
16231575|NCT01150149|Device|Surgical face mask + no face touch|
16231576|NCT01150123|Biological|Group B streptococcus (GBS) vaccine- low dose|
16231577|NCT01150123|Biological|Group B streptococcus (GBS) vaccine- High dose|
16231578|NCT01150123|Biological|Placebo- Saline|
16231579|NCT01150110|Device|resilient occlusal splints|"A resilient occlusal splints (silicone 2mm) was fabricated on the maxillary arch, using a vacuum pressing machine. The occlusal splints were adjusted to eliminate the gross interferences and to obtain occlusal stability with maximum posterior bilateral contacts.
~Patients were instructed to use the occlusal splints for 24 hours during 30 days. The use was interrupted only during meals."
16231580|NCT01150097|Drug|Tacrolimus (reduced tacrolimus)|After everolimus whole blood trough levels were confirmed to be in the target range of 3-8 ng/mL, tacrolimus tapering began, achieving a target tacrolimus whole blood trough level of 3-5 ng/mL by 3 weeks after randomization, a level which was maintained for the duration of the study.
16231581|NCT01150097|Drug|Everolimus (reduced tacrolimus)|Everolimus was started within 24 hours of randomization at a dose of 1.0 mg twice a day (bid, 2 mg daily dose). The dose was adjusted to maintain everolimus trough blood levels between 3-8 ng/mL for the duration of the study.
16231582|NCT01150097|Drug|Tacrolimus (tacrolimus elimination)|After everolimus whole blood trough levels were confirmed to be in the target range of 3-8 ng/mL, tacrolimus tapering began, achieving a target tacrolimus whole blood trough level of 3-5 ng/mL by 3 weeks after randomization. Tacrolimus elimination was started beginning at Month 4. Tacrolimus was tapered after everolimus whole blood trough levels were within the target range of 6-10 ng/mL. Tacrolimus was completely eliminated by the end of Month 4.
16231583|NCT01150097|Drug|Everolimus (tacrolimus elimination)|Everolimus was started within 24 hours of randomization at a dose of 1.0 mg twice a day (bid, 2 mg daily dose). The dose was adjusted to maintain everolimus trough blood levels between 3-8 ng/mL until Month 4; beginning with Month 4, the dose was adjusted to maintain everolimus trough blood levels between 6-10 ng/mL.
16231584|NCT01150097|Drug|Tacrolimus (tacrolimus control)|Tacrolimus trough levels were targeted to be maintained at 8-12 ng/mL until Month 4. At Month 4, tacrolimus whole blood trough levels were decreased to a target trough level of 6-10 ng/mL for the remainder of the study.
16231585|NCT01150097|Drug|Corticosteroids|For patients in all groups, corticosteroids were initiated at or prior to the time of transplantation according to local practice. Corticosteroids could be used for the duration of the study but could not be eliminated before Month 6. The corticosteroids were not specified in the protocol because they were adminsitered to the participants according to local practice as part of standard of care.
16231586|NCT01150084|Other|16-week lunchtime walking intervention|10 week group led lunchtime walks (each 30 minutes) followed by 6 weeks independent walking
16231587|NCT01150084|Other|delayed treatment|to start at week 10
16231588|NCT01150058|Genetic|western blotting|
16231589|NCT01150058|Other|flow cytometry|
16231592|NCT01150045|Drug|5-fluorouracil|Patients receive 400 mg/m^2 intravenous bolus then 2400 mg/m^2 continuous intravenous infusion over 46-48 hours.
16231593|NCT01150045|Other|placebo|Patients receive placebo administered by mouth, once daily.
16231594|NCT01150045|Drug|oxaliplatin|Patients receive 85 mg/m^2 intravenous over two hours.
16231595|NCT01150045|Drug|leucovorin|Patients receive 400 mg/m^2 intravenous over two hours.
16231596|NCT01150032|Other|Bone quality complementary exams|"realisation of following exams to evaluate fracture risk in osteopenic women:
~hip and wrist Dual energy X-ray Absorptiometry (DXA)
~wrist and shin High-Resolution peripheral Quantitative Computed-Tomography(HR-pQCT)
~hip Quantitative Computed Tomography (QCT)
~High Resolution Digital X-Ray of calcaneum using BMA(tm) system
~low-dose stereoradiography using EOS(tm) system (only for a sub-group of 60 voluntary subjects)"
16231597|NCT01150019|Other|Cross sectional study|This is not intervention study. The purpose of the study is to examine the relationship between various adipokine levels and PET imaging at the cross section setting
16231598|NCT01150006|Other|Cross sectional study|This is not intervention study. The purpose of the study is to examine the relationship between various adipokine levels and PET imaging at the cross section setting
16231599|NCT01149993|Drug|Myfortic (mycophenolic acid)|720mg twice a day for 7 days prior to transplantation
16231600|NCT01149993|Drug|Myfortic (mycophenolic acid)|720mg twice a day after transplant
16231601|NCT01149993|Drug|Thymoglobulin (anti-thymocyte globulin)|up to 25 mg will be infused into the renal artery of a donor kidney prior to transplantation into the recipient.
16231602|NCT01149993|Drug|Thymoglobulin (anti-thymocyte globulin)|standard of care for Georgetown University Hospital: 1.5 mg/kg/day infused over 6 hours.
16231603|NCT01149980|Drug|Citalopram Hydrobromide|Citalopram Hydrobromide Tablets 40 mg of Dr.Reddy's Laboratories Limited
16231604|NCT01149967|Drug|Citalopram Hydrobromide|Citalopram Hydrobromide Tablets 40 mg of Dr.Reddy's Laboratories Limited
16231605|NCT01149954|Drug|Ibuprofen|Ibuprofen 200 mg gel capsules of Dr. Reddy's Laboratories Limited
16231606|NCT01149941|Drug|Ibuprofen|Ibuprofen 200 mg gel capsules of Dr. Reddy's Laboratories Limited
16231607|NCT01149915|Drug|TH-302|TH-302 will be administered as a 30-minute intravenous infusion daily for 5 days every 21 days. Patients who successfully complete a 3-week treatment cycle without evidence of significant treatment-related toxicity or clinically significant progressive disease will continue to receive treatment for up to six cycles.
16231608|NCT01149902|Biological|Cyclophosphamide, Docetaxel, Dendritic cells, OK-432|Cyclophosphamide 50mg/day, day1-7 and 22-28 Docetaxel 30mg/m2, day6 and 27 OK-432 5KE/day, day7,14,28,35
16231609|NCT01149889|Procedure|transcranial direct current stimulation|Transcranial direct current stimulation will be applied at 2mA, 30 minutes/day, for 10 weekdays consecutively
16231610|NCT01149876|Other|Nu Skin Product|Thin layer of Nu Skin product applied to face.
16231611|NCT01149876|Other|Cosmetic instrument|Cosmetic instrument with topical Nu Skin product. Thin layer of Nu Skin product applied to face followed by galvanic, used for 3 minutes.
16231612|NCT01149876|Drug|Tretinoin cream 0.05|Thin layer of tretinoin applied to face.
16231613|NCT01149876|Other|CeraVe moisturizer|Thin layer of CeraVe applied to face.
16231614|NCT01149863|Drug|Plerixafor|Plerixafor 240 mcg/kg SC will be administered daily starting on the first day of stem cell apheresis, up to a total of 4 doses.
16231615|NCT01149850|Biological|bevacizumab|Given IV
16231616|NCT01149850|Drug|temozolomide|Given orally
16231617|NCT01149850|Other|laboratory biomarker analysis|Correlative studies
16231618|NCT01149850|Other|immunohistochemistry staining method|Correlative studies
16231619|NCT01149850|Genetic|microarray analysis|Correlative studies
16231620|NCT01149850|Genetic|DNA methylation analysis|Correlative studies
16231621|NCT01149837|Device|InnoLIA HTLV I/II Score line immunoassay|This intervention consists of testing a residual serum or plasma sample from a blood donation or donor follow-up sample using the InnoLIA HTLV I/II Score line immunoassay
16231622|NCT01149824|Drug|Salvinorin A|
16231623|NCT01149824|Drug|Placebo|
16231624|NCT01149811|Drug|Fipamezole ODT|Subjects will receive fipamezole ODT 15 mg three times daily for 1 week followed by fipamezole ODT 30 mg three times daily for 1 week, followed by a 2-week washout period. Beginning at Visit 5, subjects will receive fipamezole ODT 30 mg three times daily for 2 weeks.
16231625|NCT01149811|Drug|Fipamezole ODT Cohort 2|Subjects will receive fipamezole ODT 30 mg three times daily for 2 weeks, followed by a 2-week washout period. Beginning at Visit 5, subjects will receive fipamezole ODT 15 mg three times daily for 1 week followed by fipamezole ODT 30 mg three times daily for 1 week.
16231626|NCT01149798|Drug|Abraxane and Cisplatin combination|"Abraxane will be given at 125 mg/m2, venous infusion within 30 minutes, administered on days 1, 8 and 15.
~Cisplatin at 75mg/m2, venous infusion for 120 minutes, will be administered on day 1."
16231627|NCT01149785|Drug|crizotinib|Treatment A: a single 150-mg dose of crizotinib will be administered in the fasted state on Day 1 as 1 × 50-mg and 1 × 100-mg Immediate Release Tablets.
16231628|NCT01149785|Drug|ketoconazole|Treatment B: 200 mg twice a day (approximately 12 hrs apart) doses of ketoconazole will be administered orally on an empty stomach from Day 1 to Day 16.
16231629|NCT01149785|Drug|crizotinib|Treatment B: A single 150-mg dose of crizotinib will be administered in the fasted state on Day 4 as 1 × 50-mg and 1 × 100-mg Immediate Release Tablets.
16231630|NCT01149772|Behavioral|ACCESS|Participants received 6 treatment sessions (2 core and 4 electives). The two core modules are increasing awareness and controlling physical and emotional symptoms. After completion of the core modules the participant was able to choose elective modules from Managing Physical Health, The Power of Thoughts, Increasing Pleasant Activities, and Relaxation. Participants were required to complete the first session in person and subsequent sessions participants had the option to complete in-person or over the phone. Participants also had the option to receive 2 brief follow-up booster calls to aid in reinforcing the changes made.
16231631|NCT01149759|Drug|Cyclosporine A|5 mg/kg for first 4 weeks, followed by tapering to 1 mg/kg for 12 weeks until discontinuation at 16 weeks
16231632|NCT01149746|Drug|Tamsulosin|Test 0.4 mg Capsule
16231633|NCT01149746|Drug|Tamsulosin|Reference Listed 0.4 mg Capsule
16231634|NCT01149733|Drug|Tamsulosin|Test 0.4 mg Capsule
16231635|NCT01149733|Drug|Tamsulosin|Reference Listed 0.4 Capsule
16231636|NCT01149720|Drug|Tivantinib (ARQ 197) Capsule|Oral BID 360 mg dose (Capsule C: 6 X 60 mg) of ARQ 197 at least 1 hour before or 2 hours after a meal for 7 days
16231637|NCT01149720|Drug|Tivantinib (ARQ 197) Tablet|Oral BID 360 mg dose (Tablet: 3 x 120 mg) of ARQ 197 under fed conditions for 7 days
16231638|NCT01149720|Drug|Tivantinib (ARQ 197) Capsule D, oral|Oral BID 360 mg dose (Capsule D: 3 x 120 mg) of ARQ 197 under fed conditions in the extension phase
16231639|NCT01149707|Drug|PUR 0110 Rectal Enema 250 mg|PUR 0110 Rectal Enema 250 mg, once-daily, intrarectally
16231640|NCT01149707|Drug|PUR 0110 Rectal Enema 500 mg|PUR 0110 Rectal Enema 500 mg, once-daily, intrarectally
16231641|NCT01149707|Drug|PUR 0110 Rectal Enema 1000 mg|PUR 0110 Rectal Enema 1000 mg, once-daily, intrarectally
16231642|NCT01149707|Drug|Placebo Enema|Placebo Enema, once-daily, intrarectally
16231643|NCT01149694|Drug|PUR 0110 Rectal Enema or Placebo Enema|187.5 mg/60 g
16231644|NCT01149694|Drug|PUR 0110 Rectal Enema or Placebo Enema|375 mg/60 g
16231645|NCT01149694|Drug|PUR 0110 Rectal Enema or Placebo Enema|750 mg/60 g
16231646|NCT01149694|Drug|PUR 0110 Rectal Enema or Placebo Enema|1500 mg/60 g
16231647|NCT01149681|Drug|APLIDIN (plitidepsin)|"Aplidin® (plitidepsin) lyophilized powder and solvent for concentrate for solution for infusion. (2 mg plitidepsin vial and 4 ml ampoule).
~Plitidepsin will be administered at 5 mg/m2 intravenously diluted to a total volume of 250 ml in 0.9% saline or 5% dextrose solution on Day 1 and 15 every four weeks for a maximum period of 6 cycles."
16231648|NCT01149668|Drug|PCI-24781|Subjects enrolled in this study will receive PCI-24781 administered orally at the schedule and dosage from their prior protocol.
16231649|NCT01149655|Drug|Aripiprazole|Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg)
16231650|NCT01149655|Drug|Aripiprazole|Aripiprazole (10-mg, 15-mg, 20-mg, 25-mg or 30-mg)
16231651|NCT01149642|Dietary Supplement|Oral Impact|"The patients will benefit in each case from a similar energy supplement (either Oral Impact or placebo) during the 5 days preceding the course of chemotherapy. They will receive the supplement 3 times per day at 10am, 3pm and 5pm outside of their meals. In total, the patients will take the supplements for 15 days (3 courses of 5 days). If the patient has difficulty taking the treatment orally, it can be given via an enteral tube (nasogastric tube or percutaneous gastrostomy). All patients in the protocol will systematically receive a dietetic consultation.
~This consultation by a dietician will detect malnutrition and result in nutritional counsel if necessary (advice re. enrichment of diet, CNO without immunonutrients, artificial nutrition). Follow-up appointments with a dietician will be organised every 3 weeks to maintain adherence to the suggested dietary changes."
16231652|NCT01149642|Dietary Supplement|Placebo|The placebo is an identical formula to the Oral Impact but is not enriched with specific nutrients.
16231653|NCT01149629|Drug|Droxidopa|One capsule containing 300 mg droxidopa, given once
16231654|NCT01149629|Drug|Droxidopa|3 capsules each containing 100 mg droxidopa, give 3 times at 4 hour intervals
16231655|NCT01149629|Drug|Droxidopa|3 capsules each containing 100 mg droxidopa, given once
16231656|NCT01149616|Drug|Dexamethasone 8mg iv x1|Dexamethasone 8mg iv x1
16231657|NCT01149616|Drug|placebo|2 ml normal saline IV x1
16231658|NCT01149603|Device|HeartMate II Ventricular Assist Device|The HeartMate II Left Ventricular Assist Device has been approved by the FDA for use in bridge-to-transplant therapy and destination therapy for patients with endstage heart failure.
16231659|NCT01149590|Procedure|Computer Tomography Angiography|Computed Tomography Angiography
16231660|NCT01149577|Drug|Olanzapine|06 weeks treatment with Olanzapine in a flexible dosage schedule.
16231661|NCT01149564|Drug|iv ibuprofen|
16231662|NCT01149564|Drug|oral ibuprofen|
16231663|NCT01149538|Drug|Choline bitartrate|Choline bitartrate 500 mg. daily, administered in fruit-flavored drink mix.
16231664|NCT01149538|Dietary Supplement|Placebo for choline bitartrate|Placebo for choline bitartrate, administered daily in fruit-flavored drink mix.
16231665|NCT01149525|Drug|L-Carnitine|2g oral solution , twice per day (morning/evening), during 3 months
16231666|NCT01149525|Drug|Placebo|oral solution, twice per day (morning/evening), during 3 months
16231667|NCT01149499|Drug|Valacyclovir|1000 mg Tablet
16231668|NCT01149499|Drug|Valacyclovir|1000 mg Tablet
16231669|NCT01149486|Drug|Losartan potassium/Hydrochlorothiazide|100/25 mg Tablets
16231670|NCT01149486|Drug|Hyzaar®|100/25 mg Tablets
16231671|NCT01149473|Drug|Losartan potassium/Hydrochlorothiazide|100/25 mg Tablets
16231672|NCT01149473|Drug|Losartan potassium/Hydrochlorothiazide|100/25 mg Tablets
16231673|NCT01149460|Drug|Valacyclovir|Test 1000 mg Tablet
16231674|NCT01149460|Drug|Valacyclovir|Reference Listed Valacyclovir 1000 mg Tablet
16231675|NCT01149434|Drug|JI-101|JI-101 inhibits angiogenesis, and subsequently tumor growth, by inhibiting three receptor tyrosine kinases: VEGF Receptor Type 2 (VEGFR 2), platelet derived growth factor receptor beta (PDGFR β and Ephrin B4 (EphB4). JI-101 selectively inhibits kinases critical for all three stages of tumor angiogenesis.
16231676|NCT01149434|Drug|Everolimus|Everolimus is a signal transduction inhibitor that selectively inhibits mTOR (mammalian target of rapamycin), a key and highly conserved serine-threonine kinase, that is present in all cells and is a central regulator of protein synthesis and ultimately cell growth, cell proliferation, angiogenesis, and cell survival. mTOR is the only currently known target of everolimus (1).
16231677|NCT01149421|Drug|LY2189265|Administered as a subcutaneous injection once weekly for 26 weeks
16231678|NCT01149421|Drug|Placebo|Administered as a subcutaneous injection once weekly for 26 weeks
16231679|NCT01149408|Drug|Decitabine (Dacogen)|Decitabine; 20 mg/m2; 1 hour intravenous infusion; 1 -3 days (will be given on a 28-day cycle for up to 18 months)
16231680|NCT01149395|Drug|Dexlansoprazole|Dosage: 30 mg once per day for 4 weeks by mouth
16231681|NCT01149369|Drug|Aprepitant|Aprepitant, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
16231682|NCT01149369|Drug|Placebo|Aprepitant-placebo, 125 mg, 1 capsule, q.d. (everyday) with lunch for 4 weeks
16231683|NCT01149356|Drug|Exemestane|Given orally
16231684|NCT01149356|Drug|Gamma-Secretase Inhibitor RO4929097|Given orally
16231685|NCT01149356|Drug|Goserelin Acetate|Given subcutaneously to premenopausal patients
16231686|NCT01149343|Biological|Immunotherapeutic GSK2302025A, different formulations|Intramuscular administration
16231688|NCT01149317|Procedure|Acupuncture|Weekly acupuncture treatment for up to 14 weeks to augment usual care
16231689|NCT01149304|Drug|Pentoxifylline|Pentoxifylline is given for 8 weeks since the evening of the day of intervention with a dose of 400mg applied three times daily (morning, noon, evening).
16231690|NCT01149304|Drug|Ursodeoxycholic Acid|Ursodeoxycholic acid is administered for 8 weeks since the evening of the day of intervention. Dosage is 250mg given three times daily (morning, noon, evening).
16231691|NCT01149304|Drug|Enoxaparin|Enoxaparin with a dose of 40mg is injected subcutaneously once a day for 8 weeks since the evening of the day of intervention after the HDR-brachytherapy.
16231692|NCT01149278|Drug|maintain mean arterial pressure between 80-85 mm Hg|protocolized hemodynamic care aiming to maintain mean arterial pressure between 80-85 mm Hg
16231693|NCT01149278|Other|maintain mean arterial pressure between 65-70 mm Hg|protocolized hemodynamic care aiming to maintain mean arterial pressure between 65-70 mm Hg
16231694|NCT01149265|Behavioral|Online support group|Expressive writing involves people writing about their thoughts and feelings, often upsetting ones, for a short period of time.
16231695|NCT01149265|Behavioral|Expressive writing|Online support groups are internet forums where like-minded people give and receive both informational and emotional support.
16231696|NCT01149252|Other|Psoralait|Cream to be used as instructed.
16231697|NCT01149252|Other|Placebo cream.|Cream to be used as instructed
16231698|NCT01149213|Device|transcranial direct current stimulation|tDCS will be applied at 2mA/30 minutes, every other week during the first three months than once a month during the next three months.
16231699|NCT01149200|Drug|TC-6499|5mg enteric-coated oral hard gelatin capsule, administered twice daily
16231700|NCT01149200|Drug|Placebo|placebo as enteric-coated oral hard gelatin capsule, administered twice daily
16231701|NCT01149174|Drug|Mitomycin-C 40 mg|Intravesical instillation of Mitomycin-C
16231702|NCT01149161|Procedure|Routine central neck dissection|Level VI neck node dissection during thyroid operation
16231703|NCT01149148|Device|INVOS Somanetics Cerebral Oximeter|"Sequence of Interventions To Increase Cerebral Oxygen Saturation
~Check head and cannula position
~Increase mean arterial pressure
~Increase pump flow
~Increase systemic oxygenation
~Increase PaCO2 > 45
~Increase anesthetic depth by increasing volatile anesthetic or by administering propofol boluses
~Consider PRBC transfusion for Hct < 21%"
16231704|NCT01149148|Device|INVOS Somanetics Cerebral Oximeter|INVOS Cerebral Oximetry blinded monitoring with no deviation in surgical procedures or standard of care in anesthesia.
16231705|NCT01149135|Device|Blue enriched light with a low intensity|30 minutes in the morning, 750 lux
16231706|NCT01149135|Device|standard light treatment|standard light treatment, 30 minutes, 10 000 lux
16231707|NCT01149122|Drug|Gemcitabine/Oxaliplatin|GEMOX: (Gemcitabine 100 mg/㎡ over 100-min, Oxaliplatin 100 mg/㎡ over 2h) q (every) 2 weeks
16231708|NCT01149122|Drug|Gemcitabine/Oxaliplatin with Erlotinib (Tarceva)|GEMOX + Tarceva: (Gemcitabine 1000 mg/㎡ over 100-min, Oxaliplatin 100 mg/㎡ over 2h) q 2weeks; Tarceva 100 mg qd
16231709|NCT01149109|Drug|Temozolomide and lomustine|
16231710|NCT01149109|Drug|Temozolomide|
16231711|NCT01149096|Procedure|Bone Marrow Donation|Undergo bone marrow harvest
16231712|NCT01149096|Biological|Filgrastim|Given subcutaneously
16231713|NCT01149096|Other|Laboratory Biomarker Analysis|Optional correlative studies
16231714|NCT01149083|Drug|Carboplatin|Given IV
16231715|NCT01149083|Other|Laboratory Biomarker Analysis|Correlative studies
16231716|NCT01149083|Drug|Veliparib|Given PO
16231717|NCT01149057|Drug|tocilizumab [RoActemra/Actemra]|8 mg/kg intravenously, every 4 weeks for 96 weeks
16231718|NCT01149044|Procedure|Percutaneous Coronary Intervention with or without manual aspiration thrombectomy|
16231719|NCT01149031|Device|LOW LEVEL LASER SYSTEM|LASER DIODE CLASS 3B,OMEGA XP
16231720|NCT01149018|Drug|Tetrahydrocannabinol|Oral solution of THC in concentration of 5mg/0.2ml. Dose regimen: 5mg 2-4 times/day as tolerated.
16231721|NCT01149018|Drug|Placebo|Orally administered olive oil. Dose: 0.2ml 2-4 times a day as tolerated
16231722|NCT01149005|Drug|novorapid / humalog short acting insulin|1-4 units will be injected Subcutaneously (SC), before every main meal.
16231723|NCT01149005|Drug|Novo Rapid Insulin (Novonordisk)|Novo Rapid Insulin (Novonordisk) will be administered before each main meal 1-4 units depends on the patients weight
16231724|NCT01148992|Drug|Lofexidine|0.8mg alone and concurrent with IV cocaine infusions of 20 mg and 40 mg
16231725|NCT01148992|Drug|Placebo|0mg
16231726|NCT01148979|Drug|Lisdexamfetamine Dimesylate (Vyvanse)|Lisdexamfetamine Dimesylate (Vyvanse) capsules dose ranging from 20mg to 50 mg.
16231727|NCT01148979|Drug|Placebo|Lisdexamfetamine Dimesylate (Vyvanse)-matched placebo capsules.
16231728|NCT01148966|Drug|aminolevulinic acid|Given PO
16231729|NCT01148966|Other|laboratory biomarker analysis|Correlative studies
16231730|NCT01148966|Procedure|therapeutic conventional surgery|Standard brain tumor surgery with intra-operative frameless MRI stereotactic guidance and intra-operative ultrasound guidance
16231731|NCT01148953|Drug|ALN-TTR01|Dose levels between 0.01 and 1.0 mg/kg by intravenous (IV) infusion
16231732|NCT01148953|Drug|Sterile Normal Saline (0.9% NaCl)|Calculated volume to match active comparator
16231733|NCT01148914|Other|Inflammatory biomarkers|tTst blood samples for cardiac biomarkers at baseline, 24-hours and 3 month post-ablation
16231734|NCT01148901|Drug|Infliximab|Infliximab 5 mg/kg administered as an intravenous perfusion over a period of 2 hours at Weeks 0, 2, 6, and 14, as indicated in the Summary of Product Characteristics
16231735|NCT01148888|Drug|Magnesium|Magnesium will be administered intravenously at a dose of 50 mg/kg bolus followed by an infusion of 10 mg/kg/hr.
16231774|NCT01148511|Drug|Ranibizumab 0.5 mg|Ranibizumab was supplied as a sterile solution in sealed glass vials.
16231775|NCT01148498|Drug|solanezumab|400mg administered once intravenously
16231776|NCT01148485|Other|Nasal, throat, inguinal and skin lesions swab samples will be performed|Nasal, throat, inguinal and skin lesions swab samples will be performed
16231777|NCT01148472|Drug|Escitalopram|20mg once daily; orally
16231778|NCT01148472|Drug|Duloxetine|60mg once daily; orally
16231826|NCT01148056|Radiation|Intensity Modulated Radiation Therapy|Radiation therapy once a day for 5 days
16231736|NCT01148875|Behavioral|Mammography appointment reminders; telephone counseling|Women randomly assigned to UCR, EAPR, ELR; repeated 4 times at yearly intervals. Using claims data, supplemented by self-report, verified if women had recent mammograms. Women who remained non-adherent after reminders received Barriers-Specific Telephone Counseling Call, or an enhanced call including focus on either positive or negative consequences of getting/not getting mammograms. Prior to calls, women in each of the three phone counseling groups received priming letters to prime them to process information in the call. Priming letters should prepare women to process information from subsequent counseling calls more deeply by focusing on the positive or negative consequences of getting/not getting mammograms or on identifying and overcoming their own barriers to being screened.
16231737|NCT01148862|Device|The MiniMed Paradigm® X54 System|"The MiniMed Paradigm® X54 System: A insulin pump equipped with a number of features to actively manage the user's glucose levels. One example is the Low Glucose Suspend (LGS) feature. The LGS feature is only available when the pump is used with the subcutaneous glucose sensor for continuous glucose monitoring. To use this feature, the user will be required to select a sensor low suspend limit, or threshold, at which the LGS feature will be triggered. When this feature is selected, if the sensor glucose reading reaches the level that is equal to or less than the programmed threshold, the user receives an alert and the pump suspends."
16231738|NCT01148849|Biological|MGAH22|"MGAH22 will be administered by IV infusion once per week for 4 weeks in the following dose escalation cohorts: 0.1, 0.3, 1.0, 3.0, and 6.0 mg/kg; and once every 3 weeks in the following dose escalation cohorts: 10.0, 15.0, and 18.0 mg/kg.
~An additional cohort of up to 24 patients with breast or gastric cancer will be enrolled and treated at a dose of 15 mg/kg every three weeks."
16231739|NCT01148836|Dietary Supplement|Coenzyme Q-10 in Pulmonary Hypertension subjects|Take 100mg Co-Q for three times daily
16231740|NCT01148836|Dietary Supplement|Coenzyme Q-10 in Normal Control subjects|Take 100mg Co-Q for three times daily
16231741|NCT01148823|Other|Incisions covered for 1 day|Dressing was removed on the first postoperative day.
16231742|NCT01148823|Other|Incisions covered for 6 days|Dressing was removed on the 6th postoperative day.
16231743|NCT01148810|Drug|BAF312|
16231744|NCT01148810|Drug|Placebo|
16231745|NCT01148797|Drug|Canakinumab|
16231746|NCT01148784|Procedure|ACL reconstruction|Randomized comparison of two different allogenic tissue types, quadrupled hamstring or doubled tibialis anterior, for anterior cruciate ligament repair.
16231747|NCT01148771|Drug|ertapenem|1 gram IV bolus every 24 hours (q24h) for 3 days
16231748|NCT01148771|Drug|ertapenem|1 gram 30 minute infusion q24h for 3 days
16231749|NCT01148758|Drug|RO5323441|cohorts receiving multiple doses iv
16231750|NCT01148745|Drug|ferumoxytol|510 milligram (mg) intravenous (IV) injection (30 mg/second (sec) over 17 seconds) after at least one hour of hemodialysis (HD), second 510 mg IV injection administered at next consecutive dialysis treatment (3-5 days after first injection)
16231751|NCT01148732|Procedure|ultrasonography|a Toshiba 3.75 MHz convex ultrasonography transducer (Toshiba SSA-550A, Tochigi-ken, Japan) was placed transversely on the anterior neck just superior to the suprasternal notch and bilateral hemithorax by one of two emergency physician during emergency intubation investigators.
16231752|NCT01148719|Other|Index group|Diagnostic triage strategy includes; electrocardiography, echocardiography, spirometry and blood testing
16231753|NCT01148706|Device|ActiSight Needle Guidance System|The ActiSight™ Needle Guidance System employs a miniature video camera mounted on the needle and a reference pad attached to the skin to register the needle into the CT image space, and thus, track the needle advance towards the target. CT scans are used as needed to verify the location of the needle.
16231754|NCT01148693|Drug|gentamicin|10mg per 10ml of contrast media
16231755|NCT01148693|Drug|Placebo|Distilled water
16231756|NCT01148680|Biological|Islet Graft|Iterative injection of pancreatic islets (minimum: 250,000 IEQ / injection or 3500 IEQ / kg / injection) with a threshold required total of 11,000 IEQ / kg in 2 or 3 injections per patient)
16231757|NCT01148667|Dietary Supplement|Casein hydrolysate added with LGG|Infants drink extensively hydrolysed casein formula supplemented with LGG (ATCC 53103) 5.0 x 10 7 cfu/g to achieve a daily intake of 3.4 10 9 cfu.
16231758|NCT01148667|Dietary Supplement|Infants drink casein hydrolysate without LGG|Infants drink extensively hydrolysed casein formula without added LGG
16231759|NCT01148641|Dietary Supplement|LNS|Infants and young children will receive 10 g of LNS for test trial during 3 consecutive days (crossover design) and thereafter, 20 g per day for 14 days.
16231760|NCT01148628|Drug|RAD 001 in combination with Caelyx|RAD001 (tablets; 2.5mg) is administered daily at 5, 7.5, 10 mg. CAELYXTM (vials; 50 mg/25mL)is administered i.v.every 4 weeks at 40mg/m2. One treatment cycle is 4 weeks.
16231761|NCT01148615|Drug|Aflibercept (AVE0005)|"Pharmaceutical form: solution for infusion
~Route of administration: intravenous"
16231762|NCT01148615|Drug|Docetaxel (XRP6976)|"Pharmaceutical form: solution for infusion
~Route of administration: intravenous"
16231763|NCT01148602|Other|LED stopwatch-clock timers|"We will attach a large, in-your-face red LED stopwatch-clock timers to the patient's stretcher at the moment of ED arrival to act as a constant visual reminder to all team members (physicians, RN's, CT technologists) of the urgency of the situation."
16231764|NCT01148576|Drug|entecavir|entecavir 0.5 mg qd for 12 months
16231765|NCT01148576|Drug|entecavir|entecavir 0.5 mg qd for 12 months
16231766|NCT01148576|Drug|essentiale + entecavir|entecavir 0.5 mg qd for 12 months，Essentiale 2 tablets tid in the first 3 months and 1 tablets tid in the rest 9 months
16231767|NCT01148576|Drug|Vitamin E + entecavir|entecavir 0.5 mg qd for 12 months, Vitamin E: 100 mg bid for 12 months
16231768|NCT01148563|Device|Tele-health Monitoring|Daily tele-health monitoring data will be collected from randomized participants.
16231769|NCT01148537|Drug|Buprenorphine transdermal patch|Buprenorphine transdermal patch 5, 10, 20, and 2 * 20 mcg/h.
16231770|NCT01148537|Drug|Matching placebo transdermal patch|Placebo transdermal patch to match BTDS 5, 10, 20, and 2 * 20.
16231771|NCT01148537|Drug|Avelox (moxifloxacin hydrochloride) tablet|Moxifloxacin 400 mg tablet; 1 tablet taken orally on days 6 and 13
16231772|NCT01148524|Biological|No Vaccine|
16231773|NCT01148524|Biological|rMenB+OMV-NZ|Subjects who had received either rMenB+OMV-NZ or placebo at study month 6 in V72P10 study had a blood sample drawn for serological analyses at 18 months later (-1/+3 months).
16231779|NCT01148459|Biological|GSK Biological's Investigational Malaria Vaccine 257049|All infants enrolled to group A will receive 3 doses of the experimental vaccine. The vaccine will be administered intramuscularly.
16231780|NCT01148459|Biological|Human Diploid Cell Vaccine (HDCV) or Purified Vero Cell Rabies Vaccine (PVRV, Verorab) (Aventis Pasteur);|"To ensure consistent vaccine availability, three cell culture rabies vaccines from two manufacturers may be sourced for this trial (Aventis-Pasteur and Novartis). It will be ensured that an individual child will receive all 3 doses of cell culture rabies vaccine from the same product.
~The vaccine will be administered intramuscularly"
16231781|NCT01148459|Biological|Purified Chick Embryo Cell Culture (PCEC) Rabies Vaccine (Rabipur or equivalent) (Novartis).|"To ensure consistent vaccine availability, three cell culture rabies vaccines from two manufacturers may be sourced for this trial (Aventis-Pasteur and Novartis). It will be ensured that an individual child will receive all 3 doses of cell culture rabies vaccine from the same product.
~The vaccine will be administered intramuscularly."
16231782|NCT01148446|Drug|Cyclophosphamide|750 mg/mq IV, day 1
16231783|NCT01148446|Drug|Cyclophosphamide|50 mg/mq IV, day 1
16231784|NCT01148446|Drug|Doxorubicin|50 mg/mq IV, day1
16231785|NCT01148446|Drug|Vincristine|1,4 mg/mq (max 2 mg)IV, day 1
16231786|NCT01148446|Drug|Prednisone|75 mg/mq IV, days 1-5
16231787|NCT01148446|Drug|Prednisone|60 mg/mq IV/PO, days 1-5
16231788|NCT01148446|Drug|Epirubicin|50 mg/mq IV, day 1
16231789|NCT01148446|Drug|Vinblastine|5 mg/mq IV, day 1
16231790|NCT01148446|Drug|Rituximab|375 mg/mq IV, day 1
16231791|NCT01148446|Drug|G-CSF|300 µg tot., SC; days 7-11
16231792|NCT01148420|Drug|Medroxyprogesterone 17-Acetate|Medroxyprogesterone 20mg orally 3 times a day for 3 days
16231793|NCT01148420|Drug|medroxyprogesterone acetate|Depo Provera 150mg Intramuscular injection
16231794|NCT01148394|Other|Multimodal rehabilitation|
16231795|NCT01148368|Drug|fimasartan|single administration of fimasartan 120mg
16231796|NCT01148342|Drug|MDMA|
16231797|NCT01148342|Drug|(+/-)3,4-methylenedioxymethamphetamine Hydrochloride, MDMA HCI Capsules|0, 1.0 &amp; 1.6 mg/kg
16231798|NCT01148329|Device|Coronary stenting|The PROMUS™ Element™ Everolimus Eluting Coronary Stent System is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions. The treated lesion length should be less than the nominal stent length (8 mm, 12 mm, 16 mm, 20 mm, 24 mm, 28 mm, 32 mm, 38mm) with a reference vessel diameter of 2.25 mm - 4.0 mm.
16231799|NCT01148316|Drug|fluoxetine|drops or capsules, 10 to 80mg/Day for 14 weeks (first treatment) and as add-on to group CBT non-responders for additional 14 weeks
16231800|NCT01148316|Behavioral|Group cognitive-behavioral therapy|weekly, 2 hour sessions with one therapist and one co-therapist for 14 weeks and as add-on to fluoxetine non-responders for additional 14 weeks
16231801|NCT01148303|Drug|Etoricoxib|Subjects will take etoricoxib 90mg by mouth just before the start of the daily fast. This will be for six days. After this they will receive placebo for eight days.
16231802|NCT01148303|Drug|Etoricoxib|This arm will receive placebo just before their fast for eight days. After this they will receive etoricoxib 90mg just before their daily fast for the next six days.
16231803|NCT01148303|Drug|Placebo|Placebo
16231804|NCT01148290|Procedure|Tension free vaginal tape|Small incision sites in the vagina and suprapubically. Bilateral retropubic insertion of the sling by means of needles
16231805|NCT01148290|Procedure|Bulking agent injection|Three Periurethral injections of Bulkamid ® (Ethicon,Somerville, NJ, USA)
16231806|NCT01148277|Drug|Propofol and Remifentnyl|Intervention group (Propofol and remifentanyl): It will be administered under direct gastroenterologists' and hepatologist
16231807|NCT01148277|Drug|midazolam and fentanyl|Intervention group (Propofol and fentanyl ): It will be administered under direct gastroenterologists'and hepatologist
16231808|NCT01148277|Drug|midazolam anf fentanyl|group (Midazolam with Fentanyl): Both drugs will be administered by the gastroenterologists and/ or hepatologist and/ or anesthiologist
16231809|NCT01148264|Drug|olanzapine|1x10mg per day for three days
16231810|NCT01148264|Drug|metoclopramide|3x10mg per day for three days
16231811|NCT01148225|Drug|adalimumab|Adalimumab, pre-filled syringe, administered by SC injection
16231812|NCT01148199|Device|Self-expandable metalic stent|Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis.
16231813|NCT01148199|Device|Multiple plastic stents|Comparison of self-expandable metalic stent versus multiple plastic stents in post OLT biliary stenosis.
16231814|NCT01148186|Behavioral|knowledge transfer tool|knowledge transfer tool for empowering patients to engage in collaborative discontinuation of potentially inappropriate medication with their pharmacist and/or physician
16231815|NCT01148173|Drug|Combined systemic and intrathecal chemotherapy followed by HD-ASCT|Methotrexate Ifosfamide Cytarabine Thiotepa Liposomal cytarabine (intrathecal) Carmustine Etoposide Autologous stem cell transplantation
16231816|NCT01148160|Drug|voriconazole|intravenous, oral administration
16231817|NCT01148147|Drug|Adenosine|Intracoronary adenosine administration (180 ug for LCA and 120 ug for RCA)
16231818|NCT01148147|Drug|Placebo|Intracoronary Placebo administration
16231819|NCT01148121|Other|Skeletal Status Assessment of a Down Syndrome Population|The investigators hypothesize that the bone deficits seen in Down Syndrome patients are similar to the phenotype seen in the down syndrome mouse model (Ts65Dn).The bone turnover markers, CBC, and DXA scan results will be used to assess the skeletal status of the down syndrome patients. This data will form the basis to establish the Ts65Dn as a reasonable proxy for pathogenesis and treatment in humans.
16231820|NCT01148108|Drug|Canfosfamide HCl for injection|30 min. intravenous infusion of canfosfamide HCl (1000 mg/m2) every 2 weeks
16231821|NCT01148095|Drug|AZD2516|Oral, single, daily, 11 days
16231822|NCT01148095|Drug|Placebo|
16231823|NCT01148082|Procedure|Self administered Surveys|
16231824|NCT01148082|Procedure|Interviews|
16231825|NCT01148069|Procedure|Surgery combined with IMRT-IGRT|Patients will have surgery consisting in extensive pelvic dissection and ablation of seminal vesicles. Surgery will be followed by prolonged hormonotherapy (3 years) associated, after 2 months, with prostatic only irradiation.
16232127|NCT01145950|Drug|Enbrel|Etanercept 25mg, single dose
16231827|NCT01148043|Drug|Hydroxychloroquine|200 mg capsule, 2 capsules QD for 24 weeks.
16231828|NCT01148043|Drug|cellulose|capsule, 2 capsules QD for 24 weeks
16231829|NCT01148030|Drug|3M Skin and Nasal Antiseptic|Intra-nasal dosing
16231830|NCT01148017|Biological|Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine|
16231831|NCT01148004|Drug|Fenofibrate|
16231832|NCT01148004|Drug|Ritonavir|
16231833|NCT01148004|Drug|Lopinavir/Ritonavir|
16231834|NCT01147991|Biological|EBNA1 C-terminal/LMP2 chimeric protein-expressing recombinant modified vaccinia Ankara vaccine|
16231835|NCT01147991|Other|laboratory biomarker analysis|
16231836|NCT01147991|Other|pharmacological study|
16231837|NCT01147978|Behavioral|End of ICU stay conference|Conference with patient and proxies, senior physician and nurse regarding the ICU stay and the orientation of the patient
16231838|NCT01147965|Biological|AD5 CEA Vaccine|AD5[E1-, E2b-]-CEA Vector Vaccine
16231839|NCT01147952|Behavioral|Structured exercise training|randomised to 12 weeks of exercise training up to three times weekly. Training will be interval training with active recovery, with 3 min intervals conducted 10bpm below angina threshold.
16231840|NCT01147939|Drug|Elacytarabine|Elacytarabine 2000 mg/m2/d administered as a continuous intravenous infusion (CIV) in a d 1-5 q3w cycle.
16231841|NCT01147939|Drug|Investigator's Choice|E.g. cytarabine single agent/combinations, hypomethylating agents, best supportive care (BSC)
16231842|NCT01147926|Drug|Placebo|Placebo matched to Prucalopride tablet orally once daily.
16231843|NCT01147926|Drug|Prucalopride|Prucalopride 2 mg tablet orally once daily for subjects greater than or equal to (≥) 18 to less than (<) 65 years; 1 mg once daily orally for subjects ≥65 years, and in case of insufficient response, increased to 2 mg once daily orally at Week 2 or Week 4.
16231844|NCT01147913|Behavioral|Computerized Information-Processing Bias Retraining|The intervention consists of the presentation of three-line ambiguous scenarios via a computer program, one line at a time. A disambiguating word fragment completes the scenario (in either a positive or neutral valence, depending on the scenario), after which participants will type the first letter of the word on the keyboard to ensure they are encoding the interpretation valence. The computer will indicate if they have correctly identified the word. This is followed by a Y/N comprehension question. Each session presents 100 training scenarios.
16231845|NCT01147913|Behavioral|Attention Control Training|"Four sessions of interpretation training for filler or neutral scenarios, unrelated to themes associated with depression."
16231846|NCT01147900|Biological|Boostrix™|Intramuscular, single dose
16231847|NCT01147900|Biological|Boostrix™-US formulation|Intramuscular, single dose
16231848|NCT01147887|Drug|Drug combination/ 26489112|On Day 1 and on Day 19, a single, oral dose of a drug combination consisting of midazolam (2 mg/mL liquid), tolbutamide (a 500 mg tablet), and omeprazole (a 20 mg capsule) will be taken and on Day 4 through Day 21, a single oral dose of two 26489112 tablets will be taken.
16231849|NCT01147874|Procedure|lab draws and imaging|1 set of lab draws, imaging consists of radiographic imaging or X-ray, ultrasound and MRI
16231850|NCT01147861|Drug|GSK256073|5mg in the AM and 5mg in the PM
16231851|NCT01147861|Drug|GSK256073|10mg in the AM
16231852|NCT01147861|Drug|GSK256073|50mg in the AM
16231853|NCT01147861|Drug|GSK256073|25mg in the AM and 25mg in the PM
16231854|NCT01147861|Other|Placebo|2 placebo tablets in the AM and 2 placebo tablets in the PM
16231855|NCT01147848|Drug|Fluticasone furoate/Vilanterol Inhalation Powder|Fluticasone furoate/Vilanterol Inhalation Powder inhaled orally once daily for 24 weeks
16231856|NCT01147848|Drug|Fluticasone propionate/salmeterol Inhalation Powder|Fluticasone propionate/salmeterol Inhalation Powder inhaled orally twice daily for 24 weeks
16231857|NCT01147848|Drug|Placebo (1)|Inhalation powder inhaled orally once daily for 24 weeks
16231858|NCT01147848|Drug|Placebo (2)|Inhalation powder inhaled orally twice daily for 24 weeks
16231859|NCT01147835|Dietary Supplement|Chinese Licorice Root|Chinese Licorice Root lollipops are given to the subjects in the study group to ingest twice daily for 10 days. Then the subjects must wait 3 months, and then again ingest the lollipops twice daily for 10 days.
16231860|NCT01147822|Drug|Pazopanib|800 mg administered once daily orally continuous dosing
16231861|NCT01147822|Drug|Sunitinib|50 mg sunitinib to be administered in 6-week cycle: 50 mg orally daily for 4 weeks followed by 2 weeks off treatment
16231862|NCT01147809|Drug|Eltrombopag olamine|thrombopoietin receptor agonist
16231863|NCT01147809|Other|Placebo|Placebo tablets with no active pharmaceutical ingredient
16231864|NCT01147796|Device|computed tomography|64 slices CT with iodine injection
16231865|NCT01147796|Device|computed tomography|64 slices CT with iodine injection
16231866|NCT01147783|Other|CT, MRI|
16231867|NCT01147770|Drug|progesterone|duration
16231868|NCT01147757|Drug|remifentanil|During surgery, 3 different dose of remifentanil or placebo was infused.
16231869|NCT01147744|Drug|Fluticasone Propionate 100mcg via ACCUHALER/DISKUS|Fluticasone propionate 100mcg twice daily via ACCUHALER/DISKUS
16231870|NCT01147744|Drug|GSK2190915 100mg|GSK2190915 100mg (1 x 100mg) once daily in the morning
16231871|NCT01147744|Drug|GSK2190915 10mg|GSK2190915 10mg (1 x 10mg) once daily in the morning
16231872|NCT01147744|Drug|GSK2190915 300mg|GSK2190915 300mg (1 x 100mg, 1 x 200mg tablets) once daily in the morning
16231873|NCT01147744|Drug|GSK2190915 30mg|GSK2190915 30mg (1 x 30mg) once daily in the morning
16231874|NCT01147744|Drug|Montelukast 10mg|Montelukast 10mg (1 x 10mg capsule) once daily in the evening
16231875|NCT01147744|Drug|Placebo GSK2190915 one tablet|Placebo tablet, one tablet once daily in the morning
16231876|NCT01147744|Drug|Placebo montelukast|Placebo capsule once daily in the evening
16231877|NCT01147744|Drug|Placebo fluticasone propionate via ACCUHALER/DISKUS|Inhaled placebo twice daily via ACCUHALER/DISKUS
16231878|NCT01147744|Drug|Placebo GSK2190915 two tablets|Placebo tablet, two tablets once daily in the morning
16231879|NCT01147731|Biological|warfarin plus albiglutide|A single dose of 25mg warfarin on day 1 followed by 5 weekly doses of subcutaneous albiglutide followed by a single dose of 25mg warfarin on day 45.
16232044|NCT01146652|Drug|SAR153191 (REGN88)|"Pharmaceutical form: solution
~Route of administration: subcutaneous"
16231880|NCT01147718|Biological|digoxin plus albiglutide|A single dose of 0.5mg digoxin on Day 1 followed by 5 weekly doses of subcutaneous albiglutide, followed by a single dose of 0.5mg digoxin on Day 38.
16231881|NCT01147705|Drug|Allopurinol|Participants will be given blinded medication and asked to take one tab/day for the first six weeks (100mg strength for two weeks then 300mg strength for four weeks) followed by two tabs/day for the remaining 18 weeks
16231882|NCT01147705|Drug|Placebo|Same appearance/dosing as active drug.
16231883|NCT01147692|Biological|simvastatin plus albiglutide|A single dose of 80mg simvastatin on Day 1 followed by 5 weekly doses of subcutaneous albiglutide followed by a single dose of 80mg simvastatin on Day 38.
16231884|NCT01147666|Drug|FG-4592|Different dose levels
16231885|NCT01147666|Drug|Epoetin Alfa|Per current label instruction
16231886|NCT01147666|Drug|FG-4592|Different dose levels
16231887|NCT01147666|Other|Placebo|Inactive capsules matching appearance of FG-4592 capsules
16231888|NCT01147666|Drug|Epoetin Alfa|Per current label instruction
16231889|NCT01147653|Biological|Autologous UCB Reinfusion|Autologous umbilical cord blood (UCB) reinfusion
16231890|NCT01147653|Other|Placebo|Placebo
16231891|NCT01147640|Drug|CXA-101/ tazobactam and metronidazole|CXA-101/tazobactam (1000/500 mg q8h) plus metronidazole (500 mg q8h) administered via IV infusion
16231892|NCT01147640|Drug|meropenem plus saline placebo|meropenem IV infusion (1000 mg q8h) plus a matching saline placebo (q8h) administered via IV infusion
16231893|NCT01147627|Drug|exenatide injection|Patients in exenatide group will be treated with exenatide (Byetta®, Eli Lilly and Company) 5 µg BID for the first 4 weeks and then 10 µg BID thereafter.
16231894|NCT01147627|Drug|Mixed Protamine Zinc Recombinant Human Insulin Lispro 25R|Patients in insulin group will be treated with premixed insulin analog (Humalog Mix 25, Eli Lilly and Company). The initial insulin doses are 0.4 IU/kg per day(50% before breakfast and 50% before dinner). Insulin doses are titrated following a forced schedule according to blood glucose before breakfast and dinner.
16231895|NCT01147627|Drug|Pioglitazone|Patients in thiazolidinedione group will be treated with Pioglitazone 30mg daily as single dose. The dose will be increased to 45mg daily after 4 weeks.
16231896|NCT01147614|Behavioral|Brief Cognitive Behavioral Therapy (BCBT)|BCBT: 8-12 sessions over 16 weeks of cognitive-behavioral therapy administered by Master's-level clinicians in primary care setting
16231897|NCT01147614|Behavioral|Specialty mental health care referral (SMHC)|SMHC: specialty mental health care referrals provided
16231898|NCT01147601|Drug|topical 0.5% Timolol|topical 0.5% Timolol aqueous solution, 2-3 drops to cover the hemangioma, twice daily
16231899|NCT01147601|Drug|Control (placebo) group|Control (placebo) group
16231900|NCT01147588|Drug|lansoprazole|60 mg (2x30-mg capsule), once daily
16231901|NCT01147588|Drug|omeprazole|80 mg (2x40-mg capsule), once daily
16231902|NCT01147588|Drug|esomeprazole|40 mg (1x40-mg capsule), once daily
16231903|NCT01147588|Drug|clopidogrel|300 mg loading dose on Day 1 then 75 mg daily for 28 days
16231904|NCT01147575|Dietary Supplement|Creatine monohydrate|The patients received orally 200 mg CMH per kg body weight divided in three doses per day. Following period 1 (6 months) of supplementation and a wash-out period of 4 weeks without CMH the groups were switched for another 6 months (period 2).
16231905|NCT01147575|Dietary Supplement|Placebo|The patients received orally 200 mg Placebo per kg body weight divided in three doses per day. Following period 1 (6 months) of supplementation and a wash-out period of 4 weeks without placebo the groups were switched for another 6 months (period 2).
16231906|NCT01147562|Procedure|Collection of biospecimen|Collection of saliva, blood and tissues from subjects diagnosed with lung cancer, who are scheduled for biopsy of their lesion or surgical resection of their tumor.
16231907|NCT01147549|Drug|[C14]AZD9668|Oral Solution 60 mg Single Dose
16231908|NCT01147536|Biological|HSPPC-96|
16231909|NCT01147523|Drug|Spironolactone/Vitamin E|Spironolactone, tablets, 25 mg daily plus Vitamin E, capsules, 400 mg daily, for 52 weeks
16231910|NCT01147510|Drug|Combination of low ICS and montelukast|Two puffs of Pulmicort ® turbuhaler 200µg/puff between 7 a.m. and 10 a.m and take orally a tablet of Singulair® 10mg one time per day.
16231911|NCT01147510|Drug|Monotherapy of medium dose ICS|Two puffs of Pulmicort ® turbuhaler 200µg/puff between 7 a.m. and 10 a.m. and between 7 p.m. and 10 p.m. two times per day
16231912|NCT01147497|Drug|Misoprostol|400mcg of misoprostol taken buccally 2 hours prior to IUD insertion visit
16231913|NCT01147497|Drug|Placebo|Pill that is identical to the study drug in appearance, taste and smell, taken buccally 2 hours prior to IUD insertion visit
16231914|NCT01147484|Drug|Foretinib|foretinib, at a continuous oral daily dose of 60 mg
16231915|NCT01147471|Device|operative rib fixation|Randomized subjects will be operated upon within 72 hours of ventilation (early fixation)to stabilize the stove-in segment using a rib fixation system.
16231916|NCT01147471|Procedure|operative rib fixation surgery|
16231917|NCT01147458|Drug|PF-04191834|100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks
16231918|NCT01147458|Drug|PF-04191834 placebo|Matching PF-04191834 placebo tablets to be administered BID for two weeks
16231919|NCT01147458|Drug|Naproxen placebo|Matching naproxen placebo tablets to be administered BID for 4 weeks
16231920|NCT01147458|Drug|PF-04191834 placebo|Matching PF-04191834 placebo tablets to be administered BID for two weeks
16231921|NCT01147458|Drug|PF-04191834|100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks
16231922|NCT01147458|Drug|Naproxen placebo|Matching naproxen placebo tablets to be administered BID for 4 weeks
16231923|NCT01147458|Drug|PF-04191834|100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks
16231924|NCT01147458|Drug|Naproxen|Naproxen 500 mg tablet administered BID for a total of four weeks
16231925|NCT01147458|Drug|PF-04191834 placebo|Matching PF-04191834 placebo tablets to be administered BID for two weeks
16231926|NCT01147458|Drug|Naproxen|Naproxen 500 mg tablet administered BID for a total of four weeks
16231927|NCT01147458|Drug|PF-04191834 placebo|Matching PF-04191834 placebo tablets to be administered BID for two weeks
16231928|NCT01147458|Drug|PF-04191834|100 mg tablets of PF-04191834 to provide a 600 mg BID dose administered for two weeks
16232124|NCT01145963|Other|Experimental pasta B|experimental pasta
16231929|NCT01147445|Biological|Double Mutant Heat- Labile Toxin (dmLT)|LT(R192G/L211A), or dmLT is a derivative of wild-type enterotoxigenic Escherichia coli heat labile enterotoxin. LT(R192G/L211A) is formulated as a freeze-dried (lyophilized), white to off-white cake, containing 700 micrograms of vaccine protein in a 3 mL, multi-dose, Wheaton Serum Vial. Vaccine dosage levels: 5, 25, 50, 100 micrograms as a single, oral dose.
16231930|NCT01147432|Drug|PF-04427429|Single dose IV infusion up to 300mg
16231931|NCT01147432|Other|Capsaicin challenge|Capsaicin challenge: 110 mg (0.075% capsaicin) to be applied at pre-dose and at 2h, 5h, 8h and 24h post-dose as well as 1 week and 4 weeks post final treatment period
16231932|NCT01147432|Drug|Placebo|Placebo IV infusion (saline) to be administered during two of the three treatment periods
16231933|NCT01147432|Other|Capsaicin challenge|Capsaicin challenge: 110 mg (0.075% capsaicin) to be applied at pre-dose and at 2h, 5h, 8h and 24h post-dose as well as 1 week and 4 weeks post final treatment period
16231934|NCT01147432|Other|EMLA positive control|2g EMLA cream to be applied ONCE during study period 1
16231935|NCT01147419|Device|stent|Before operation, take aspirin 100mg every day. During the operation, stent is delivered by a catheter and positioned through the narrowing in the artery. The stent is then expanded against the wall of the blood vessel to provide a wider channel for blood. At last, use balloon dilate the stent.
16231936|NCT01147419|Device|femoral-popliteal bypass with artificial blood vessel|Before operation, take aspirin 100mg every day. Groin and suprageniculate incision, PTFE graft with end to side anastomoses.
16231937|NCT01147406|Drug|N6022|This is an injectible formulation which will be given at 5, 15 & 45 mg over 1, 3 and 9 minutes respectively, in single ascending doses.
16231938|NCT01147406|Drug|Placebo|This will be 0.9% normal saline given over 1, 3, or 9 minutes IV bolus.
16231939|NCT01147393|Drug|90Y-epratuzumab tetraxetan|The 90Y-epratuzumab treatment will begin one week after the 4th veltuzumab injection. Patients will receive unlabeled, unconjugated epratuzumab (1.5 mg/kg) that will be infused over ~30 minutes. All patients will then receive a 90Y-epratuzumab dose. Dose will be escalated by patient cohort either at 15 mCi/m2 or 20 mCi/m2. The second 90Y-epratuzumab treatment will be given at the same dose, 1 week after the first 90Y-epratuzumab dose.
16231940|NCT01147393|Biological|veltuzumab|Veltuzumab is given in 4 weekly doses, each 200 mg/m2.
16231941|NCT01147380|Biological|Liver NK cell inoculation|Liver transplant recipients will receive once liver NK cell inoculation several days after liver transplantation.
16231942|NCT01147367|Behavioral|3 month physical activity intervention|3 month physical activity intervention involving moderate intensity walking and strength training with resistance bands
16231943|NCT01147354|Dietary Supplement|selenium yeast|The patients in this arm took 200 micrograms of selenium yeast daily for 12 weeks.
16231944|NCT01147354|Other|placebo capsules|The patients in this arm took one placebo capsule daily for 12 weeks.
16231945|NCT01147341|Drug|Cimzia|prefilled 200mg Cimzia syringe SC q 2 weeks
16231946|NCT01147341|Drug|Placebo|prefilled saline syringe
16231947|NCT01147328|Other|Virtual Health Record (VHR)|Technology that enables providers to electronically access community-wide clinical data for patients who have consented to have their clinical data accessed via a web portal.
16231948|NCT01147315|Procedure|Hybrid bone substitution|The patient will be treated by hybrid bone substitution with calcium-phosphate ceramic biomaterial and autologous bone marrow after necrosis exeresis
16231949|NCT01147302|Biological|Placebo|
16231950|NCT01147302|Biological|C1 Esterase Inhibitor (Human)|
16231951|NCT01147289|Drug|Dextralgen|Dexalgen® will be administered at a dose equivalent to dexamethasone 1.5 mg, dipyrone 500 mg, and hydroxocobalamin 5 mg (one ampoule for each type) a day at a single intramuscular dose. Both drugs will be administered for 3 days, at least.
16231952|NCT01147289|Drug|Meloxicam|Meloxicam (Movatec®, Boehringer Ingelheim) will be administered as 15 mg (one ampoule) a day at a single intramuscular dose. Both drugs will be administered for 3 days, at least.
16231953|NCT01147276|Drug|Vildagliptin|Vildagliptin (50 mg BID) in four weeks
16231954|NCT01147263|Other|Evaluation of autonomic parameters|Physical examination, ECG, Loop recorder, Heart rate variability evaluation
16231955|NCT01147250|Drug|Lixisenatide (AVE0010)|Pharmaceutical form: Sterile aqueous solution; Route of administration: Subcutaneous within 1-hour before breakfast using self-injector pen device (Opticlik®). If the maintenance dose of 20 mcg was not tolerated, dose could be reduced to 15 or 10 mcg.
16231956|NCT01147250|Drug|Placebo|Pharmaceutical form: Sterile aqueous solution; Route of administration: Subcutaneous within 1-hour before breakfast.
16231957|NCT01147237|Device|Intracoronary stent implantation|Everolimus-eluting stent implantation in patients with long coronary artery disease
16231958|NCT01147224|Drug|Alvesco|This is an observational study. Therefore, the physician decides about dosage according to individual needs.
16231959|NCT01147211|Drug|MK2206|MK-2206 will be administered orally in a starting dose level of 135 mg on a schedule of Qwk in repeating 3-week treatment cycles in combination with gefitinib in continuous 21-day cycles for the duration of the study
16231960|NCT01147198|Dietary Supplement|Ready to Use Supplementary Food|Children received two Supplementary-plumpy® packages per day (184g) providing 1000 Kcal, 26g (10.4%) protein, 68g (61.2%) fat, and 100% of micronutrient requirements based on the Daily Recommended Nutrient Intake.
16231961|NCT01147198|Dietary Supplement|Premix CSB-oil treatment|Children received 2 kg of premix per week (226g CSB, 37g oil, and 23g sugar / day) providing 1277 Kcal, 40.7g protein (12.7%), 50.6g (35.7%) fat, and 100% of micronutrient according to the DRNI guidelines
16231962|NCT01147185|Device|Locomotor training using a robotic device|50min walking time, 3-5 trainings/week.
16231963|NCT01147185|Device|Locomotor training using a robotic device|25min walking time, 3-5 trainings/week.
16231964|NCT01147172|Device|Elevess|Injectable gel, 0.5mL or 1.0mL material supplied in a 1.0mL pre-filled sterile glass syringe with two 30 gauge needles
16231965|NCT01147159|Other|Extracts of allergens|Skin prick test of extracts of allergens in 4 tenfold dilutions. Assessment wheal size after 15 minutes
16231966|NCT01147146|Drug|propofol, fentanyl, atracurium|general anesthesia
16231967|NCT01147146|Drug|bupivacaine|spinal anesthesia
16231968|NCT01147146|Drug|bupivacaine, Midazolam|spinal anesthesia & sedation
16231969|NCT01147133|Drug|Plavix|1x75 mg
16231970|NCT01147133|Drug|Kardogrel|1x75 mg
16231971|NCT01147120|Behavioral|Progressive Muscle Relaxation (PMR)|Progressive Muscle Relaxation (PMR) will be recorded on PDAs integrated with EMA software and offered to patients who will be instructed in the techniques and PDA use by study coordinators. They will be instructed to practice 25 minutes/day the first two weeks, 35 minutes/day weeks 3 and 4, and 45 minutes/day weeks 5 through 12. These time periods (25/35/45 minute) were selected to allow a more gradual acclimation to PMR.
16231972|NCT01147120|Procedure|Clinical Massage Therapy (CMT)|PCPs will have the opportunity to refer patients with CLBP to local Licensed Massage Therapists (LMTs) to receive up to 10 clinical massage sessions over a 12-week period. CMT will be provided at no cost to the patients. At their first two sessions, the LMT will evaluate the patient and, with the patient, estimate the number of sessions and determine treatment goals. Based on previous literature, 10 sessions are anticipated over an average 12-week period. However, treatment will vary depending on assessment and progress. At the end of the treatment period, the patients will receive a list of all participating LMTs to facilitate patients' continued or future participation in massage therapy.
16231973|NCT01147107|Drug|Raltegravir|Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Raltegravir 400 mg twice daily
16231974|NCT01147107|Drug|Efavirenz|Emtricitabine/tenofovir DF* 200 mg/300 mg po daily + Efavirenz 600 mg po daily
16231975|NCT01147081|Biological|BEGRIVAC|126 healthy subjects enrolled to receive, in open-label manner, one dose of Begrivax (influenza vaccine)
16231976|NCT01147068|Biological|0.5mL Intramuscular Injection|0.5mL intramuscular injection on day 0 and day 21 in the deltoid muscle
16231977|NCT01147055|Drug|crizotinib|Treatment A: a single 250-mg dose of crizotinib will be administered in the fasted state on Day 1 as 1 × 50-mg and 2 × 100-mg Immediate Release Tablets.
16231978|NCT01147055|Drug|rifampin|Treatment B: 600 mg once a day doses of rifampin will be orally administered after overnight fasting from Day 1 to Day 14.
16231979|NCT01147055|Drug|crizotinib|Treatment B: A single 250-mg dose of crizotinib will be administered in the fasted state on Day 9 as 1 × 50-mg and 2 × 100-mg Immediate Release Tablets.
16231980|NCT01147042|Drug|IFN-gamma|Following a washout period subjects have a subcutaneous injection of 50 mcg per meter squared once per week, Monday, for 4 weeks, twice per week, Monday and Thursday, for 4 weeks, then thrice per week, Monday, Wednesday, Friday, for 4 weeks. Total treatment period is 12 weeks.
16231981|NCT01147029|Drug|angiogenesis inhibitor GSAO|
16231982|NCT01147029|Other|laboratory biomarker analysis|
16231983|NCT01147029|Other|pharmacological study|
16231984|NCT01147029|Procedure|dynamic contrast-enhanced magnetic resonance imaging|
16231985|NCT01147016|Biological|HER2Bi-armed activated T cells|Total of 4 of the T cell infusions intravenously over a period of 1 month.
16231986|NCT01147016|Drug|cyclophosphamide|As prescribed by physician, standard of care.
16231987|NCT01147016|Drug|doxorubicin hydrochloride|As prescribed by physician, standard of care.
16231988|NCT01147016|Drug|paclitaxel|As prescribed by physician, standard of care.
16231989|NCT01147016|Other|laboratory biomarker analysis|Immune studies will be done pre-immunotherapy, prior to the third infusion of activated T-cells, at the time of surgery, and 1 month after immunotherapy. If there are positive findings, additional optional studies will be done at 3, 6, and 12 months, if the immune studies show changes worthy of follow-up studies.
16231990|NCT01147016|Procedure|neoadjuvant therapy|As prescribed by physician, standard of care.
16231991|NCT01147016|Procedure|therapeutic conventional surgery|As recommended by physician, post immunotherapy.
16231992|NCT01147003|Drug|Investigational new drug, company code: BGG492|
16231993|NCT01147003|Drug|Placebo|
16231994|NCT01147003|Drug|Investigational new drug, company code: BGG492|
16231995|NCT01146990|Drug|ASQ-3, Bayley III, Neurologic exam|Developmental Scales of infant development - Children born to mothers who participated in the 17P-ES-003 study will be enrolled in this study and evaluated using the ASQ-3. Those meeting protocol criteria based on ASQ-3, will be evaluated using the Bayley III and have a neurologic examination.
16231996|NCT01146977|Other|HDAC chemotherapy|If he/she decides not to participate, he/she will be treated with HDAC consolidation chemotherapy, which is the current standard treatment.
16231997|NCT01146977|Other|Autologous HCT|"After achieving CR1, patient will be invited to this protocol and will be able to decide whether to join or not after listening to the information.
~If he/she decides to participate, request of health insurance support on the autologous HCT will be submitted and further processes related to autologous HCT will continue."
16231998|NCT01146964|Procedure|MSSICS|Manual super small incision cataract surgery
16231999|NCT01146964|Procedure|Phacoemulsification|cataract surgery with Phacoemulsification
16232000|NCT01146951|Drug|Rufinamide (E2080)|"Rufinamide tablets administered orally twice daily after breakfast and dinner. Treatment was divided into a Dose Titration Period (2 weeks) and a Dose Maintenance Period (10 weeks). As a general rule, the dose was increased by 1 step every 2 days until it reached the target maintenance dose determined by body weight at the start of the Observation Period.
~Target maintenance dose:
~15.0 - 30.0 kg: 1000 mg/day (5 tablets each in the morning and evening) 30.1 - 50.0 kg: 1800 mg/day (4 tablets in the morning and 5 in the evening) 50.1 - 70.0 kg: 2400 mg/day (6 tablets each in the morning and evening) >= 70.1 kg: 3200 mg/day (8 tablets each in the morning and evening)"
16232001|NCT01146951|Drug|Placebo|Rufinamide Matching Placebo tablets administered orally twice daily after breakfast and dinner for a total of 12 weeks.
16232002|NCT01146938|Drug|fimasartan|single administration of fimasartan 120mg
16232003|NCT01146938|Drug|fimasartan|single administration of fimasartan 120mg
16232004|NCT01146925|Drug|CRMD-001-Deferiprone|CRMD-001 represents unique formulations of Deferiprone. Subjects will be given one (900 mg) immediate release and two (900 mg) extended release tablets 1-3 hours prior to angiography and then every 12 hours for a total of 8 days
16232005|NCT01146925|Drug|Placebo|3 placebo tablets will be given every 12 hours for a total of 8 days, beginning 1-3 hours prior to angiography
16232006|NCT01146912|Other|Text Message|Text message vaccine reminders
16232007|NCT01146912|Other|automated call|Automated call
16232008|NCT01146899|Other|Provider Alert|Provider influenza vaccine alert
16232009|NCT01146886|Drug|Placebo to BI 135585|Part 1 - oral doses given to approximately 9 parallel groups of 8 subjects (6 on active and 2 on on placebo) on Day 1
16232125|NCT01145963|Other|Experimental pasta C|experimental pasta
16232010|NCT01146886|Drug|BI 135585|Part 1 - oral doses given to approximately 9 parallel groups of 8 subjects (6 on active and 2 on placebo) on Day 1; Part 2 - oral doses given to 12 subjects on Day 1
16232011|NCT01146873|Drug|Efavirenz (EFV)|Children are assigned to begin a EFV-based antiretroviral based regimen.
16232012|NCT01146873|Drug|Lopinavir/ritonavir (LPV/r)|Children are assigned to stay on their current LPV/r-based antiretroviral regimen.
16232013|NCT01146873|Drug|Stavudine (D4T)|Children are assigned to stay on their current antiretroviral regimen which includes D4T.
16232014|NCT01146873|Drug|Abacavir (ABC)|Children stop taking D4T and switch to ABC.
16232015|NCT01146860|Drug|BNO 1016|sugar coated tablets with dry extract (80 mg) of 5 herbal drugs; dosage: 480 mg per day (2 tablets t.i.d.) duration: 15 days
16232016|NCT01146860|Drug|Placebo|sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration 15 days
16232017|NCT01146847|Device|Space TGC|Space TGC with incorporated eMPC algorithm to establish tight glycaemic control with a blood glucose target range of 80-110 mg/dL (4.4-6.1 mM)
16232018|NCT01146834|Drug|bortezomib (Velcade)|1.3 mg/m2 IVP on days 1, 4, 8 and 11
16232019|NCT01146834|Drug|cyclophosphamide|2.0 g/m2 (day 4 for Arm A and day 1 for Arm C)
16232020|NCT01146834|Drug|G-CSF|given for ten (+/- two) consecutive days starting on day 9 at a dose of 10 micrograms/kg/day (start on day 2 for Arm C and start on Day 1 for Arm D)
16232021|NCT01146834|Drug|Plerixafor|plerixafor is given on day 4, approximately 11 hours prior to stem cell collection attempt on Day 5, plerixafor daily until stem cell collection is complete (Arm D), start on Day 12, approximately 11 hours prior to stem cell collection attempt and plerixafor daily until collection if complete (Arm E)
16232022|NCT01146821|Dietary Supplement|0.20 gm/kg fish oil|Group 2: 7 patients will receive 0.20gm/kg of ideal body weight [IBW] fish oil in addition to standard care
16232023|NCT01146821|Dietary Supplement|0.50 gm/kg fish oil|Group 3: 7 patients will receive 0.50 gm/kg of ideal body weight [IBW] fish oil in addition to standard care.
16232024|NCT01146808|Drug|Adefovir dipivoxil and hepatitis B vaccination|Adefovir 10mg po daily, or adjusted for renal function and option for Hepatitis B vaccination, double dose
16232025|NCT01146795|Drug|Carboplatin|Carboplatin will be administered at a concentration-time curve (AUC) of 5-6 (at the discretion of the physician) day 1 every 3 weeks in combination with Paclitaxel and Bevacizumab.
16232026|NCT01146795|Drug|Paclitaxel|Paclitaxel 175 mg/m2 over 3 hours day 1 every 3 weeks in combination with Carboplatin and Bevacizumab.
16232027|NCT01146795|Drug|Bevacizumab|Bevacizumab 15 mg/kg day 1 every 3 weeks in combination with Paclitaxel and Carboplatin.
16232028|NCT01146782|Device|Attune Sleep Apnea System|Console and mouthpiece sleep apnea system
16232029|NCT01146769|Other|Pelvic floor exercise|Pelvic floor strengthening exercise
16232030|NCT01146756|Drug|AZD6244|MEK inhibitor AZD6244 (Selumentinib) in combination with thoracic radiotherapy
16232031|NCT01146743|Procedure|EUS-guided gallbladder drainage|EUS-guided gallbladder drainage was performed with a linear-array echoendoscope. The initial puncture was performed at the antrum of the stomach or bulb of the duodenum and was chosen to access the gallbladder body or neck and avoid visible vessels. After removal of the needle, a 6F or 7F bougie were inserted and then removed to dilate the tract. Afterward, nasobiliary drainage tube or stent was placed.
16232032|NCT01146743|Procedure|percutaneous transhepatic gallbladder drainage|Under ultrasound guidance, needle punctured to gallbladder via percutaneous transhepatic route.
16232033|NCT01146730|Behavioral|Workcoping and IPS|Maximum 15 sessions of CBT-based counseling with workcoping as primary focus in addition to work support according to the IPS-model (individual placement and support)
16232034|NCT01146730|Behavioral|Ordinary care by GP or NAV|Ordinary care by the participants physician or the local Labour and Welfare Administration
16232035|NCT01146717|Behavioral|Exercise|Patients with mild cognitive impairment will undergo moderate intensity endurance exercise training for one year.
16232036|NCT01146717|Behavioral|Balance training|A group of patients with mild cognitive impairment will perform flexibility and balance training for one year as a control group.
16232037|NCT01146704|Dietary Supplement|Protein powder supplement, standard dosage based on 0.5 gram protein per pound of subject's lean body mass|Standard protein diet as control, based on 0.5 gram protein per pound of lean body mass, isocaloric (same number of calories) and consisting of 15% protein and 55% carbohydrate.
16232038|NCT01146704|Dietary Supplement|Protein powder supplement, High Level Protein, based on 1 gram of protein per pound of lean body mass: 25% protein and 45% carbohydrate|High level of protein diet, based on 1 gram of protein per pound of subject's lean body mass, isocaloric (same number of calories) and consisting of 30% protein and 40% carbohydrate.
16232039|NCT01146691|Other|Alternative Intensivist staffing models|During the study period, each participating ICU alternated (ABAB or BABA) between two distinct intensivist staffing formats: (i) the standard staffing model, an intensivist is responsible for care in that ICU for the entire 7 days, being present during the daytime hours, and taking call from home at night, (ii) the 24-7 in-hospital, shiftwork model, enabled by splitting each 24 hour period into two shifts. There will, as in the standard model, be a single intensivist covering the ICU during the day shifts for one week. The day shift will run 8 am to 5:30 pm on weekdays, and 8 am to 3 pm on Saturday and Sunday. The night shift intensivist will arrive and take over at 5:30 pm on weekdays, and 3 pm on weekends and remain in the hospital until 8 am.
16232040|NCT01146678|Drug|Insulin glargine HOE901|"Pharmaceutical form:solution for injection
~Route of administration: subcutaneous"
16232041|NCT01146678|Drug|Lixisenatide AVE0010|"Pharmaceutical form:solution for injection
~Route of administration: subcutaneous"
16232042|NCT01146665|Behavioral|Computer-based PAF|This intervention includes standard medical care followed by receipt of computer-based Personalized Assessment Feedback (PAF). PAF is a type of brief intervention that targets norm misperceptions, for example summarizing a person's drinking in comparison to the average male or female in the general population. Theoretically, such normative feedback corrects norm misperceptions and motivates drinkers to re-evaluate their consumption patterns.
16232043|NCT01146665|Behavioral|Computer-based Sham|This intervention includes standard medical care followed by receipt of a computer-based sham. The sham is similar in format and duration as the computer-based Personalized Assessment Feedback but will engage youth in nutrition and exercise-related questions.
16232126|NCT01145950|Drug|LBEC0101|Etanercept 25mg, single dose
16232045|NCT01146639|Radiation|DynaCT|One extra set of images with DynaCT including one extra injection of contrast medium.
16232046|NCT01146639|Drug|Iodixanol|One extra set of images with DynaCT including one extra injection of 50 ml contrast medium.
16232047|NCT01146626|Drug|Peg+ Vitamin D+ Ribavirine|Peg+ Vitamin D+ Ribavirine
16232048|NCT01146626|Drug|Peg+ Ribavirine|Peg+ Ribavirine
16232049|NCT01146613|Drug|Varenicline|0.5mg capsules x 2, 2x a day for 12 weeks
16232050|NCT01146613|Drug|Placebo|identical matched placebo x 2, 2xday, 13 weeks
16232051|NCT01146600|Drug|Clarithromycin followed by placebo|Clarithromycin 500 mg po bid for two weeks, then one week with no medication, then matched placebo po bid for two weeks.
16232052|NCT01146600|Drug|Placebo then Clarithromycin|Matched placebo po bid for two weeks, then one week with no intervention, then clarithromycin 500 mg po bid for two weeks
16232053|NCT01146587|Device|GangTrainer GT1|30 minutes of treatment on the GangTrainer GT1 and 30 minutes of Conventional Physiotherapy every workday for 8 weeks
16232054|NCT01146587|Device|Lokomat|30 minutes of treatment on the Lokomat and 30 minutes of Conventional Physiotherapy every workday for 8 weeks
16232055|NCT01146587|Other|Conventional Physiotherapy|60 minutes of Conventional Physiotherapy every workday for 8 weeks
16232056|NCT01146574|Biological|Sotatercept|Part 1: Sotatercept single dose 0.1mg/kg subcutaneous Part 2: Sotatercept starting dose groups of 0.3mg/kg, 0.5mg/kg or 0.7 mg/kg in a sequential design, dosed subcutaneously every 28 days for up to 8 doses
16232057|NCT01146574|Biological|Placebo|Placebo
16232058|NCT01146561|Biological|Tanezumab|single administration of tanezumab 20 mg sub-cutaneously
16232059|NCT01146561|Other|Placebo|single administration of placebo to match tanezumab, sub-cutaneously
16232060|NCT01146548|Drug|FLUOXETINE|20mg/d, oral administration for 6 weeks, then 40mg/d for 4 months.
16232061|NCT01146535|Drug|Interferon-alpha|150 IU lozenges bid for 5 days
16232062|NCT01146535|Drug|Oseltamivir|75 mg capsules bid for 5 days
16232063|NCT01146535|Other|maltose|200 mg maltose lozenges bid for 5 days
16232064|NCT01146522|Drug|LCQ908|
16232065|NCT01146522|Drug|Placebo|
16232066|NCT01146509|Drug|Aricept (donepezil hydrochloride)|Donepezil hydrochloride tablet: initial 5 mg/day dose was taken orally, once a day. At Week 4 visit, the dose was increased to 10 mg/day at the discretion of the investigator.
16232067|NCT01146496|Device|Ultraviolet light-resistant plastic in-ground pesticide storage container|In-ground pesticide storage container to be supplied to every household that uses pesticides in intervention villages
16232068|NCT01146483|Drug|Rosuvastatin, Pantoprazole|"Rosuvastatin, 10 mg tablets, single dose on the morning
~Concomitant drug: Pantoprazole; 40 mg tablets, 2 single doses administered 1 hour before rosuvastatin and 23 hours after rosuvastatin administration. A placebo is given on the other period as a crossover design study."
16232069|NCT01146470|Dietary Supplement|RGC|dosage of Red Grape Cells once a day, during 3 months
16232070|NCT01146470|Dietary Supplement|Placebo|dosage of Placebo once a day, during 3 months
16232071|NCT01146457|Drug|Morphine|Active dosage
16232072|NCT01146457|Drug|Saline|Saline Control
16232073|NCT01146444|Other|UV A and B irradiation|UV irradiation
16232074|NCT01146431|Drug|Inhaled anesthetics|Inhaled anaesthetic drugs (sevoflurane or desflurane) concentration will be changed on the basis of hemodynamic parameters (mean arterial pressure and heart rate greater or less than 20% compared to preoperative values).
16232075|NCT01146431|Drug|Inhaled anesthetics|Inhaled anaesthetic drugs (sevoflurane or desflurane) concentration will be changed on the basis of Bispectral Index (BIS) value which will be maintained between 40 and 50.
16232076|NCT01146418|Biological|Corifollitropin alfa|Single injection of 150 μg corifollitropin alfa administered under protocol P06029
16232077|NCT01146418|Biological|recFSH (follitropin beta)|Daily recFSH 300 IU administered under protocol P06029.
16232078|NCT01146379|Other|Intensive task-specific upper extremity rehabilitation|The experimental intervention consists of intensive task-specific upper extremity movement rehabilitation which are appropriately graded and progressed for each subject. This intervention will provide progressive training of these essential components required for upper extremity movement through repeated practice of various tasks, with the desired goal of building the subject's capacity to perform a multitude of UE functions. Subjects will participate in the intervention for eight weeks or more depending on the group they are randomized to.
16232079|NCT01146340|Radiation|Hypofractionated radiotherapy|40 Gy / 5 fractions / 29 days
16232080|NCT01146327|Drug|PF-04620110|Multiple oral doses of 5 mg of PF-04620110 will be given once daily for 2 weeks.
16232081|NCT01146327|Drug|PF-04620110|Multiple oral doses of 1.5 mg of PF-04620110 will be given twice daily for 2 weeks.
16232082|NCT01146327|Drug|PF-04620110|Multiple oral doses of 3 mg of PF-04620110 will be given once daily for 2 weeks.
16232083|NCT01146327|Drug|PF-04620110|Multiple oral doses of 2.5 mg of PF-04620110 will be given twice daily for 2 weeks.
16232084|NCT01146327|Drug|Placebo|Multiple oral doses of placebo will be given once daily for 2 weeks.
16232085|NCT01146314|Behavioral|Family Focused Lifestyle Intervention|The lifestyle intervention is a 6-month intervention study lasting 6 months. The intervention is 14 sessions and conducted by a dietician and psychologist in a group setting with each intervention session lasting 90 minutes. The sessions are conducted weekly, biweekly, and monthly over the course of 6 months.
16232086|NCT01146301|Drug|Clopidogrel|All patients will receive a loading dose of 600mg of study medication. The first group will receive 300 mg of clopidogrel and 300 mg placebo, the second group will receive 600mg of clopidogrel at least 24h before carotid stenting
16232087|NCT01146288|Drug|Furosemide first, then Acetazolamide|Two renal function studies will be performed: one before and after intravenous furosemide and the second before and after intravenous acetazolamide. Subjects will receive 300 mg of lithium carbonate at 22.00 the day before the renal function tests. A priming dose of inulin (50 mg/kg) and p-aminohippuric acid (8 mg/kg) will be administered and a 200-300 ml p.o water load will be given. Thereafter, inulin and p-aminohippuric acid will be infused continuously. After the first 60 minutes, 8 accurately timed urine collections of 30 to 40 minutes will be obtained by spontaneous voiding. After the first 4 timed urine collections, participants will receive intravenous furosemide 2 mg/5min or intravenous acetazolamide 5 mg/kg/5 min.Four other times urine collections will be performed thereafter.
16232088|NCT01146288|Drug|Acetazolamide first, then Furosemide|Two renal function studies will be performed: one before and after intravenous acetazolamide and the second before and after intravenous furosemide. Subjects will receive 300 mg of lithium carbonate at 22.00 the day before the renal function tests.A priming dose of inulin (50 mg/kg) and p-aminohippuric acid (8 mg/kg) will be administered and a 200-300 ml p.o water load will be given. Thereafter, inulin and p-aminohippuric acid will be infused continuously. After the first 60 minutes, 8 accurately timed urine collections of 30 to 40 minutes will be obtained by spontaneous voiding. After the first 4 timed urine collections, participants will receive intravenous furosemide 2 mg/5min or intravenous acetazolamide 5 mg/kg/5 min.Four other times urine collections will be performed thereafter.
16232089|NCT01146275|Radiation|Radiologial breast examination|MRI of breast, mammography and ultrasound of breast
16232090|NCT01146262|Other|cell therapy product|Patients receive for up to 5 doses of apoptotic corpse pulsed dendritic cells after CR1 ou CR2 documentation (9/10 subcutaneously and 1/10 intradermally) every week, except the last injection performed at 2 weeks from the 4th injection.
16232091|NCT01146262|Procedure|injection of the cell therapy product|Cytapheresis D0: 1st injection of the cell therapy product, J7 2nd injection of the cell therapy product, J14 third injection of the cell therapy product,J17 cutaneous biopsies, J21 fourth injection of the cell therapy product, J35 fifth injection of the cell therapy product
16232092|NCT01146249|Other|Balance assessment under sensory stimulation|Balance assessment under sensory stimulation
16232093|NCT01146236|Device|Sutures|Orthopedic surgical wounds closed with sutures
16232094|NCT01146236|Device|Staples|Orthopedic surgical wounds closed with metallic staples
16232095|NCT01146223|Other|laboratory biomarker analysis|Correlative studies
16232096|NCT01146210|Other|laboratory biomarker analysis|Correlative studies
16232097|NCT01146197|Drug|TREATMENT|Patients with received in random order 75mg/day indometacin(chronoindocid®), 10-20 mg/day amiloride and 50-150 mg /day eplerenone (Inspra ®). The three 6 weeks-periods of treatment will be followed by six weeks washout period. 3-6 weeks before the first period of treatment, a supplementation with potassium and magnesium will be orally given, and maintained at the same dose throughout the study and stoped 6 weeks after the end of the third period of treatment.
16232098|NCT01146184|Device|Flexible endoscope and Ethicon Manually Articulating Device|Using the Flexible Endoscope and the Ethicon Manually Articulating Device, removal of the gallbladder through a single incision is improved.
16232099|NCT01146171|Drug|BMS-844203 (CT-322)|Injection, IV, 1 and 2 mg/kg, Weekly, Until disease progression or unacceptable toxicity became apparent
16232100|NCT01146158|Procedure|Axillary dissection for breast carcinomas|surgery Axillary dissection
16232101|NCT01146145|Drug|Ketamine|intravenous morphine titration combined to ketamine
16232102|NCT01146132|Dietary Supplement|Conventional diet +/- wine|usual eating habits
16232103|NCT01146132|Dietary Supplement|Luxembourg variant of Mediterranean diet + physical activity +/- wine|"Walnuts, almonds, mustard and soy bean products as part of the Indo-Mediterranean diet could be recommended to ensure a variety of food constellation, as well as dark chocolate. This form of diet will be addressed to as Luxembourg variant of the Mediterranean diet"
16232104|NCT01146119|Biological|Multimeric-001, 500 mcg|Adjuvanted Multimeric-001 was administered twice with an interval of 19-23 days.
16232105|NCT01146119|Biological|Adjuvanted PBS|Adjuvanted PBS was administered twice with an interval of 19-23 days.
16232106|NCT01146119|Biological|PBS and TIV 15%|PBS (Phosphate Buffered Saline) was administered twice with an interval of 19-23 days and then 60 days later a 15% dose of commercial seasonal trivalent vaccine (season 2011) was administered.
16232107|NCT01146119|Biological|PBS and TIV 50%|PBS (Phosphate Buffered Saline) was administered twice with an interval of 19-23 days and then 60 days later a 50% dose of commercial seasonal trivalent vaccine (season 2011) was administered.
16232108|NCT01146106|Drug|Pravastatin Sodium|Pravastatin Sodium Tablets 80 mg
16232109|NCT01146093|Drug|Pravastatin Sodium|Pravastatin Sodium Tablets 80 mg
16232110|NCT01146080|Device|Promus Element|Promus Element implanted to treat coronary artery lesions.
16232111|NCT01146080|Device|Promus|Promus stent implanted to treat coronary artery lesions
16232112|NCT01146067|Drug|Rivastigmine|Rivastigmine capsules 1.5 mg
16232113|NCT01146054|Device|CyberKnife based stereotactic radiotherapy|"Initial orthogonal images will be obtained to confirm location of fiducial seeds.
~Synchrony respiratory tracking system must be used to correct for respiratory associated tumor motion. This system utilizes a series of optical diodes placed upon the patient's chest wall. While the orthogonal images are obtained, the computer generates a model correlating the position of the chest wall with the position of the internal fiducials. This model is continuously updated during treatment to correct for subtle changes in tumor location.
~Quality assurance will be performed as per standard practice at each participating institution."
16232114|NCT01146054|Drug|Gemcitabine|Treatment calculated per the needs of each patient and given at the instruction of the investigator; iv (intravenous).
16232115|NCT01146054|Drug|Fludeoxyglucose (18F) (FDG)|FDG-PET/CT scan is used in treatment planning. Treatment with 18F-FDG is calculated per the needs of each patient and given at the instruction of the investigator; iv
16232116|NCT01146041|Drug|Rivastigmine|Rivastigmine 1.5 mg Capsules
16232117|NCT01146028|Drug|Tizanidine|Tizanidine HCl Tablets 4 mg
16232118|NCT01146015|Biological|Trivalent influenza subunit vaccine Influvac|3x 15mcg HA per 0.5 ml,trivalent one injection at Day 1
16232119|NCT01146002|Drug|Guanfacine (sustained release)|Treated with study drug once screening and initial testing is completed (see protocol above)
16232120|NCT01145989|Drug|AT9283|Starting dose will be 40 mg/m2/day OR 30 mg/m2/day to be confirmed at registration. IV 24 hour continuous infusion Days 1 and 8 every three weeks
16232121|NCT01145976|Drug|Cy-ATG|"Hydration with 0.45% NaCl at 6 liters/24 hours will be started on day -5. Cy 50 mg/kg in D5W 200 ml i.v. over 1-2 hours on days -5 to -2 by pump through a central venous catheter.
~Thymoglobuline 3 mg/kg in N/S 500-800 mL (less than 0.5 mg/mL) or lymphoglobuline 15 mg/kg in N/S 500-800 mL (less than 2 mg/mL) iv daily at 8 am on days -4 to -2"
16232122|NCT01145976|Drug|Flu-ATG|Fludarabine 30 mg/m2 will be infused intravenously over 30 minutes in D5W 100 ml for 6 consecutive days (days -7 to -2) Thymoglobuline 3 mg/kg in N/S 500-800 mL (less than 0.5 mg/mL) or lymphoglobuline 15 mg/kg in N/S 500-800 mL (less than 2 mg/mL) iv daily at 8 am on days -4 to -2
16232123|NCT01145963|Other|Control pasta|control pasta
16232128|NCT01145937|Procedure|PET|Partial Endothelial Trepanation in addition to an anterior lamellar keratoplasty
16232129|NCT01145937|Procedure|DALK|Conventional DALK grafting procedure, with Big Bubble technique according to Anwar et al.
16232130|NCT01145924|Procedure|EBUS TBNF|Transbronchial needle forceps will be use with the EBUS TBNA scope
16232131|NCT01145898|Drug|(Cosopt®, prostaglandin)|We did NOT provide any intervention, we observed groups of patients already on these drugs as observers only.
16232132|NCT01145885|Drug|BI 6727|PLK-1 inhibitor
16232133|NCT01145872|Behavioral|Mindfulness Based Cognitive Therapy|
16232134|NCT01145872|Behavioral|Health Enhancement Program|
16232135|NCT01145859|Drug|Rivaroxaban (Xarelto, BAY59-7939)|Weight adjusted dose with equivalent exposure compared to 10 mg or 20 mg doses in adults
16232136|NCT01145846|Drug|Cytarabine plus Daunorubicin [Arm II (AD regimen)]|Cytarabine 200 mg/m2/day by continuous iv infusion over 24 hours daily for 7 days (D 1-7) plus Daunorubicin 90 mg/m2/day iv daily for 3 days (D 1-3)
16232137|NCT01145833|Other|Immediate Treatment Group|The immediate treatment group starts the 5-month treatment right after baseline assessment.
16232138|NCT01145833|Other|Delayed Treatment Group|The delayed treatment group does not start treatment immediately after the baseline assessment. This group serves as the control group, by not receiving any treatment for 5 months. After the 5 months, the delayed group participants are asked to come in for a second assessment that involves completion of surveys and measurement of height, weight, and physical activity level. After this assessment is completed, the delayed group participants can begin the 5-month treatment.
16232139|NCT01145820|Dietary Supplement|Juice plus|Juice Plus (2 capsules bds) for 11 weeks (10 weeks preop and 1 week postop)
16232140|NCT01145807|Drug|TDT067|Study treatment (TDT 067, Transfersome® vehicle, or non Transfersome® placebo) will be applied twice a day for 48 weeks to the great toenail and the other nails and areas surrounding the nails on the foot. Each application will consist of 5 sprays: 1 spray each to the dorsal, medial, anterior, and frontal part of the great toe and a final spray applied evenly to the nail area of the remaining 4 toes. Patients will be instructed not to wash the treated foot or bathe for at least 4 hours after product application.
16232141|NCT01145807|Drug|Placebo|Study treatment (TDT 067, Transfersome® vehicle, or non Transfersome® placebo) will be applied twice a day for 48 weeks to the great toenail and the other nails and areas surrounding the nails on the foot. Each application will consist of 5 sprays: 1 spray each to the dorsal, medial, anterior, and frontal part of the great toe and a final spray applied evenly to the nail area of the remaining 4 toes. Patients will be instructed not to wash the treated foot or bathe for at least 4 hours after product application.
16232142|NCT01145807|Drug|Transfersome|Study treatment (TDT 067, Transfersome® vehicle, or non Transfersome® placebo) will be applied twice a day for 48 weeks to the great toenail and the other nails and areas surrounding the nails on the foot. Each application will consist of 5 sprays: 1 spray each to the dorsal, medial, anterior, and frontal part of the great toe and a final spray applied evenly to the nail area of the remaining 4 toes. Patients will be instructed not to wash the treated foot or bathe for at least 4 hours after product application.
16232143|NCT01145794|Behavioral|smoking hygiene intervention|The intervention, SHI, will address SHS and quitting. It will include behavioral counseling to address health hazards of SHS for children, brief advice to quit and to adopt a no smoking policy around children and self-help materials (related to second hand smoking).
16232144|NCT01145781|Procedure|Cryotherapy|Arm 1 Single-freeze technique; 3 minutes of freeze and 5 minutes of thaw. Arm 2 Double-freeze technique: 3 minutes of freeze and 5 minutes of thaw and cycle repeated once again.
16232145|NCT01145768|Drug|TC-5214|4 mg tablet, oral, BID, group 1
16232146|NCT01145768|Drug|TC-5214|TBD tablet, oral, BID, groups 2-6
16232147|NCT01145768|Drug|Placebo|
16232148|NCT01145755|Drug|AZD2066|18 mg once daily
16232149|NCT01145755|Drug|Placebo|
16232150|NCT01145755|Drug|Duloxetine|60 mg once daily
16232151|NCT01145742|Behavioral|home health/primary care collaboration|self-management support and telemonitoring of BP and blood glucose
16232152|NCT01145729|Behavioral|Biomarker Feedback|Providing providers biomarker feedback on childhood secondhand smoke exposure
16232153|NCT01145716|Procedure|Arthroscopy, surgery|Ulno-volar wrist approach to the TFCC
16232154|NCT01145703|Dietary Supplement|RDA Vitamin D3 only|800 IU of Vitamin D3 daily for 6 months
16232155|NCT01145703|Dietary Supplement|Vitamin D2/3 Repletion only|Vitamin D repletion with 50,000 IU of Vitamin D2/3 up to 3 x week(until levels are >75 nmol/l; 6-12wks) followed by 6 months maintenance supplementation with 2000 IU Vitamin D3 and up to 1000mg Calcium daily
16232156|NCT01145703|Other|Vitamin D2/3 Repletion + AEX|Vitamin D repletion with 50,000 IU of Vitamin D2/3 up to 3 x week(until levels are >75 nmol/l; 6-12wks) followed by 6 months maintenance supplementation with 2000 IU Vitamin D3 and up to 1000mg Calcium daily plus aerobic exercise training
16232157|NCT01145703|Other|Vitamin D2/3 Repletion + RT|Vitamin D repletion with 50,000 IU of Vitamin D2/3 up to 3 x week(until levels are >75 nmol/l; 6-12wks) followed by 6 months maintenance supplementation with 2000 IU Vitamin D3 and up to 1000mg Calcium daily plus resistance training
16232158|NCT01145677|Drug|Topiramate|Topiramate 100-300 mg/day orally twice per day
16232159|NCT01145664|Drug|Herbal concentrate-granules plus western therapy|Intervention time: 7-10 days; Follow-up time: 5 days.
16232160|NCT01145664|Drug|Reduning Injection plus western therapy|Intervention time: 7-10 days; Follow-up time: 5 days.
16232161|NCT01145664|Drug|Western therapy|Intervention time: 7-10 days; Follow-up time: 5 days.
16232162|NCT01145638|Drug|iron isomaltoside 1000|intravenously as bolus or infusion, 500 mg or 1000mg up to full replacement dose
16232163|NCT01145638|Drug|iron sulphate|oral, 200 mg per day (100 mg bid),12 weeks
16232164|NCT01145625|Drug|5% Minoxidil|half a cap (equivalent to 1g) 5% Minoxidil Topical Foam applied to the scalp once daily, every day, for 52 weeks
16232165|NCT01145625|Drug|2% Minoxidil|one ml of 2% Minoxidil Topical Solution applied to the scalp two times a day, every day, for 52 weeks
16232166|NCT01145612|Drug|Losartan|Losartán dosage: 12.5 mg /day for patients < 50 Kg or 25 mg/day for patients > 50 Kg (14 days). 50 mg/day from day 15 to the end of the study. Half of dose (25 mg/day) for patients < 50 Kg
16232167|NCT01145612|Drug|Atenolol|Atenolol dosage: 12.5 mg /day for patients < 50 Kg or 25 mg/day for patients > 50 Kg (14 days). 50 mg/day from day 15 to the end of the study. Half of dose (25 mg/day) for patients < 50 Kg
16232168|NCT01145586|Drug|Lactase Oral Tablets|3 tablets/day for 42 days Take with breakfast, lunch and dinner
16232169|NCT01145573|Dietary Supplement|Calcium or Placebo|Participants are randomized to take either 1000mg of calcium or placebo from week 16 of pregnancy until delivery.
16232170|NCT01145560|Drug|AZD9773|A single loading dose following by up to 9 maintenance doses; doses to be given every 12 hours over a period of 5 days
16232171|NCT01145560|Drug|Placebo|Placebo
16232172|NCT01145547|Device|Dexcom Seven® Plus Continuous Glucose Monitoring sensor|A Dexcom Seven® Plus Continuous Glucose Monitoring sensor was inserted subcutaneously into each subject.
16232173|NCT01145534|Drug|glibenclamide|5 mg as pills, taken daily during the morning for 60 days
16232174|NCT01145534|Other|medicinal plant infusion|INfusion fo Cissus verticillata L., 1 g in 150 mL water, ingested daily for 60 days.
16232175|NCT01145508|Drug|Docetaxel|Given IV
16232176|NCT01145508|Other|Laboratory Biomarker Analysis|Correlative studies
16232177|NCT01145508|Drug|Prednisone|Given PO
16232178|NCT01145508|Biological|Recombinant Fowlpox-PSA(L155)/TRICOM Vaccine|Given SC
16232179|NCT01145508|Biological|Rilimogene Galvacirepvec|Given SC
16232180|NCT01145495|Other|Laboratory Biomarker Analysis|Correlative studies
16232181|NCT01145495|Drug|Lenalidomide|Given PO
16232182|NCT01145495|Biological|Rituximab|Given IV
16232183|NCT01145482|Drug|Insulin|20 IU of insulin was administered once daily on two occasions in either the first intervention period or second intervention period using a nasal spray bottle
16232184|NCT01145482|Other|Saline|200 micro liters of saline was administered once daily on two separate occasions in either the first intervention period or second intervention period using a nasal spray bottle
16232185|NCT01145469|Genetic|DNA analysis|
16232186|NCT01145469|Genetic|gene expression analysis|
16232187|NCT01145469|Genetic|polymorphism analysis|
16232188|NCT01145469|Other|laboratory biomarker analysis|
16232189|NCT01145469|Other|medical chart review|
16232190|NCT01145456|Drug|gamma-secretase/Notch signalling pathway inhibitor RO4929097|Given orally
16232191|NCT01145456|Drug|gemcitabine hydrochloride|Given IV
16232192|NCT01145456|Other|pharmacological study|Correlative studies
16232193|NCT01145456|Other|laboratory biomarker analysis|Correlative studies
16232194|NCT01145443|Other|Alternative Intensivist staffing models.|During the study period, each participating ICU alternated between two distinct intensivist staffing formats: (i) in the Discontinuous arm of the study, there was a weekend cross-coverage format wherein an intensivist was responsible for care for a two week or half-month block, but colleagues covered the weekends within each block, or (ii) in the Continuous arm of the study, there was an uninterrupted staffing format, wherein a single intensivist was responsible for the entire two week, or half-month, period. In each ICU the study interval was divided into three phases, so that the models alternated twice in each ICU, beginning with either the weekend cross-coverage or the uninterrupted staffing formats, the four hospitals were randomly assigned between these two patterns.
16232195|NCT01145430|Other|Laboratory Biomarker Analysis|Correlative studies
16232196|NCT01145430|Drug|Pegylated Liposomal Doxorubicin Hydrochloride|Given IV
16232197|NCT01145430|Other|Pharmacological Study|Correlative studies
16232198|NCT01145430|Drug|Veliparib|Given PO
16232199|NCT01145417|Drug|pregabalin (Lyrica)|150 mg-600 mg/day (twice daily)
16232200|NCT01145404|Drug|Lapatinib|Lapatinib (Tyverb) po 1500mg daily d1-21, new cycle will be started on day 22 until progression.
16232201|NCT01145404|Drug|Lapatinib plus capecitabine|Lapatinib po 1250mg daily d1-21; new cycle will be started on day 22 until progression
16232202|NCT01145391|Other|Active Outreach to Patients and Providers|An outreach coordinator raised patient and provider awareness of unmet Blood Pressure goals, arranged Blood Pressure-focused clinic visits, and furnished providers with treatment decision support.
16232203|NCT01145365|Procedure|Exam under anesthesia (EUA)|EUA established drainage of perianal fistulas &/or abscesses will be done before patient begins medical therapy with certolizumab (Cimzia)
16232204|NCT01145352|Drug|Etanercept (genetical recombination)|All patients who administrated ENBREL for active polyarticular juvenile idiopathic arthritis (restricted to the case of lack of effect by other treatment) during registered period (2.5 year).
16232205|NCT01145339|Drug|Lactase|1 chewable tablet of the test drug or comparative drug 30 minutes before the standard lactose dose (25 g).
16232206|NCT01145326|Drug|4% lidocaine gel application with sham microneedle device|Topical 4% lidocaine gel (LG4) applied to subject, after application of sham microneedle device (FMA).
16232207|NCT01145326|Drug|Microneedle-facilitated lidocaine application|Application of 4% lidocaine gel (LG4), after application of microneedle (FMA) device
16232208|NCT01145248|Device|double-balloon enteroscopy forceps biopsy|An endoscopic retrograde cholangiography (ERC) with a duodenoscope Olympus TFJ 160-R (Olympus Corp., Tokyo, Japan) and endoscopic sphincterotomy with an Olympus papillotome (Olympus) is performed under analgosedation . Then, the cannulation of the bile duct is performed by a pusher using a guidewire/guiding catheter. Subsequently, 2 histology samples are taken via a double-balloon enteroscopy (DBE) forceps (BF1725DF, Fujinon GmbH, Willich, Germany), which is placed under the guidance of the pusher.
16232209|NCT01145248|Device|Transpapillary brush cytology|An endoscopic retrograde cholangiography (ERC) with a duodenoscope Olympus TFJ 160-R (Olympus Corp., Tokyo, Japan) and endoscopic sphincterotomy with an Olympus papillotome (Olympus) is performed under analgosedation . The region of interest is then brushed five times in both directions to obtain cytology specimen.
16232210|NCT01145222|Drug|A. CNS 7056|Initial low dose plus supplemental doses as necessary.
16232211|NCT01145222|Drug|B. CNS 7056|Initial intermediate dose plus supplemental doses as necessary.
16232212|NCT01145222|Drug|C. CNS 7056|Initial high dose plus supplemental doses as necessary.
16232213|NCT01145222|Drug|D. Midazolam|Initial standardized dose plus supplemental doses as necessary.
16232214|NCT01145209|Drug|Fludarabine Phosphate|Given IV
16232215|NCT01145209|Biological|Ofatumumab|Given IV
16232216|NCT01145209|Drug|Cyclophosphamide|Given IV
16232302|NCT01144650|Drug|Placebo|Patients will receive either a single total dose of 250 mg placebo IV and oral dosage
16232303|NCT01144637|Biological|IMVAMUNE®|0.5 ml IMVAMUNE® vaccine containing at least 1 x 10E8 TCID50 (standard dose)
16232217|NCT01145183|Drug|Doxazosin|Doxazosin is initiated at 4 mg/wk, and titrated up to a maximum of 8 mg/day over approximately 2 weeks. Participants will be maintained on 6mg-8mg daily dosing until week 13. The subjects will undergo the discontinuation from the study medication during weeks 14 -15.
16232218|NCT01145183|Drug|Placebo|Matched placebo daily dosing
16232219|NCT01145170|Radiation|Radiotherapy|Radiotherapy will be given at the standard dose between 54 and 60 Gy for irradiation of tumors of the central nervous system.
16232220|NCT01145170|Biological|Nimotuzumab|The patients will receive the induction therapy for 12 weeks. If the patient reaches a complete, partial response (CR, PR) to the treatment or is at least evaluated as stable disease (SD) on week 12, the consolidation therapy should be initiated. The consolidation therapy will consist of the nimotuzumab administration, every 2 weeks.
16232221|NCT01145157|Device|Signature Knee Guide|Total Knee Arthroplasty performed using Signature Knee Guide
16232222|NCT01145157|Device|Conventional Instrumentation|Total Knee Arthroplasty performed using Conventional Instrumentation
16232223|NCT01145157|Device|Computer Assisted Navigation|Total Knee Arthroplasty performed using Computer Assisted Navigation
16232224|NCT01145144|Drug|dehydroepiandrosterone crystalline fine powder|
16232225|NCT01145131|Other|Intact or minced beef meat|135 gram piece of intact or minced beef meat, beef steak or minced beef resp.
16232226|NCT01145105|Procedure|neural dynamics techniques treatment|Treatment group- will receive neural mobilizations techniques, to improve movement of the sciatic nerve.
16232227|NCT01145105|Procedure|placebo treatment|Control group- will receive placebo treatment that will include mobilization to the upper limb. After the placebo treatment, these patients will receive neural mobilizations techniques.
16232228|NCT01145092|Behavioral|exercise training, endurance training|The endurance training group exercised on a cycle ergometer (90% of power output determined at the respiratory compensation point = RCP). The duration of each training unit was increased with time. The resistance group trained on 8 weight machines where the workload gradually increased every 2-3 weeks. At week 13 an additional physical examination, OGTT and spiro-ergometry for adjusting the training were performed.
16232229|NCT01145079|Device|Zotarolimus-eluting stent|Zotarolimus-eluting stent
16232230|NCT01145079|Device|Zotarolimus-eluting stent for ACS and DM|Zotarolimus-eluting stent for ACS and DM
16232231|NCT01145079|Device|Everolimus-eluting stent for long lesion|Everolimus-eluting stent for long lesion
16232232|NCT01145079|Device|Sirolimus-eluting stent for short lesion|Sirolimus-eluting stent for short lesion
16232233|NCT01145066|Drug|borage/echium oil combination|borage/echium oil combination containing 0.85g/day SDA and 1.7g/day GLA
16232234|NCT01145066|Dietary Supplement|fish oil|1.6g/day EPA and 1.08g/day DHA
16232235|NCT01145066|Dietary Supplement|corn oil|contains 4.5 g/day linoleic acid
16232236|NCT01145027|Other|Breakfast tray|The sensorial stimulus will be a breakfast meal, with excellent presentation and aroma, composed by favorite food items previously related by the individual for this meal. The meal will not be offered for immediate intake, it will be placed in front of the volunteer for perception of the smell and taste.
16232237|NCT01145014|Drug|BI 660848|2 mg oral drinking solution
16232238|NCT01145014|Drug|BI 660848|10 mg oral drinking solution
16232239|NCT01145014|Drug|BI 660848|20 mg oral drinking solution
16232240|NCT01145014|Drug|BI 660848|50 mg oral drinking solution
16232241|NCT01145014|Drug|BI 660848|100 mg oral drinking solution
16232242|NCT01145014|Drug|BI 660848|150 mg oral drinking solution
16232243|NCT01145014|Drug|BI 660848|200 mg oral drinking solution
16232244|NCT01145014|Drug|BI 660848|400 mg oral drinking solution
16232245|NCT01145014|Drug|BI 660848|600 mg oral drinking solution
16232246|NCT01145014|Drug|BI 660848|10,0 mg immediate release tablet
16232247|NCT01145014|Drug|BI 660848|50,0 mg immediate release tablet
16232248|NCT01145014|Drug|Placebo|matching placebo (oral drinking solution and IR tablets)
16232249|NCT01145001|Behavioral|Cognitive Behavioural Therapy|Weekly CBT for all subjects
16232250|NCT01145001|Behavioral|Contingency Management|incentives given for abstinence based on urine analysis
16232251|NCT01145001|Drug|Nicotine Transdermal Patch|14mg ir 21mg doses based on weight and #cigs/day
16232252|NCT01144988|Drug|Bevacizumab / Irinotecan|Bevacizumab (10mg/kg KG) Irinotecan (125 mg/ m2 or 340 mg/m2 depending on usage of EIAED)
16232253|NCT01144975|Drug|XOMA 052|Sterile solution, dose level varies by dose group and study drug administration day, SC injections administered by study personnel at time points specified in the protocol (the subject will receive a total of 8 injections)
16232254|NCT01144975|Drug|Placebo|Sterile solution, SC injections administered by study personnel (the subject will receive a total of 8 injections)
16232255|NCT01144962|Procedure|Localization, curettage of the fistulous tract and closure of the internal opening without MSC injection.|Patients will undergo surgical localization, curettage of the fistulous tract and closure of the internal opening, without injection of MSCs.
16232256|NCT01144962|Procedure|Localization, curettage of the fistulous tract and closure of the internal opening with local MSC injection.|Patients will undergo surgical localization, curettage of the fistulous tract and closure of the internal opening, with local injection of indicated dose of MSCs
16232257|NCT01144949|Drug|silodosin|one silodosin 8 mg capsule orally, once daily, with food for up to 4 weeks
16232258|NCT01144949|Drug|placebo|one placebo capsule orally, once daily, with food for up to 4 weeks
16232259|NCT01144936|Drug|VX-985 or matching placebo|low dose
16232260|NCT01144936|Drug|VX-985 or matching placebo|high dose
16232261|NCT01144936|Drug|VX-985 or matching placebo|dose TBD
16232262|NCT01144923|Other|Gabapentin and/or Nortriptyline, Physical therapy|Nortriptyline up to 125 mg po qhs, and / or Gabapentin up to 1200 mg po q8h, Physical therapy (e.g. range of motion, strengthening, therapeutic massage, TENS)
16232263|NCT01144923|Procedure|Epidural Steroid Injections (ESI)|Series of up to 3 cervical epidural steroid injections (ESI) with depo-methylprednisolone
16232264|NCT01144923|Other|Combination treatment|Series of up to 3 cervical epidural steroid injections with depo- methylprednisolone plus Nortriptyline up to 125 mg po qhs and /or Gabapentin up to 1200 mg po q8h, and Physical therapy (e.g. TENS, exercise, range of motion)
16232265|NCT01144910|Other|methacholine challenge test|"2 ml of liquid-dissolved methacholine in concentration of 16 mg/ml dosed in 5 steps of 0.01 mg, 0.1 mg, 0.4 mg, 0.8 mg, and 1.6 mg. 2 minutes after each step up an impulse oscillometry (IOS) and spirometry will be performed.
~the challenge will be stopped in case of a ≥ 20% decrease from baseline in FEV1 (PD20) and 0,2 mg Salbutamol will be given."
16232266|NCT01144910|Other|methacholine challenge test|"2 ml of liquid-dissolved methacholine in concentration of 16 mg/ml dosed in 5 steps of 0.01 mg, 0.1 mg, 0.4 mg, 0.8 mg, and 1.6 mg. 2 minutes after each step up an impulse oscillometry (IOS) and spirometry will be performed.
~the challenge will be stopped in case of a ≥ 20% decrease from baseline in FEV1 (PD20) and 0,2 mg Salbutamol will be given."
16232267|NCT01144897|Radiation|PET Acetate scan|PET Acetate scans will be done to detect prostate cancer lesions.
16232268|NCT01144897|Drug|Carbon-11 labeled Acetate|C-11 Acetate is a radiotracer used in PET scanning
16232269|NCT01144884|Other|Procedure (education and exercise)|education/exercise
16232270|NCT01144858|Other|a complete transesophageal echocardiography|All patients were evaluated by a complete transesophageal echocardiography with multiplane probes with a 7-MHz transducer before catheter ablation .LA appendage flow was obtained by placing the pulsed Doppler sample volume at the orifice of the LA appendage, after which peak flow velocities were measured and averaged within each RR interval of 10 consecutive cardiac cycles
16232271|NCT01144845|Procedure|Thoracic surgery|Thoracoscopy or anterior thoracotomy
16232272|NCT01144832|Drug|ebastine|20 milligram capsule once daily
16232273|NCT01144832|Drug|placebo capsule|one capsule once daily
16232274|NCT01144806|Behavioral|Nutrition education|Parent/care givers of children with severe malnutrition in enrolled in this group will be given nutrition education using the principles of infant and young child feeding (IYCF) and dietary diversification
16232275|NCT01144806|Dietary Supplement|RUTF|Ready to use therapeutic food (RUTF / PlumpyNut) will be provided to the parent/care givers of children with severe malnutrition in enrolled in this group
16232276|NCT01144767|Behavioral|Computer-generated advisor|Weekly sessions with a computer generated advisor who offers advice, feedback and guidance on physical activity
16232277|NCT01144767|Behavioral|Comparison control condition|Weekly/biweekly sessions with a group facilitator to receive health education and information.
16232278|NCT01144754|Drug|Rituximab|Calculated per patient
16232279|NCT01144741|Other|PTSD Checklist-Civilian (PCL-C)|Completed by patients before the interview; it is a 17-item survey listing of symptoms of posttraumatic stress disorder.
16232280|NCT01144741|Other|Modified Flanagan Quality of Life Scale|Completed by patients before the interview; it is a 16-item survey designed for use in persons with chronic illness.
16232281|NCT01144741|Other|Center for Epidemiologic Studies Depression Scale (CES-D)|Completed by patients before the interview; it is a 20-item survey that asks about depressive feelings and behaviours in the past week.
16232282|NCT01144741|Other|Functional Enquiry (or Review of Systems) Form|Completed during the interview; it is a checklist of medical problems.
16232283|NCT01144741|Other|Study of Therapeutic Outcomes and Practices in Freeman-Sheldon Syndrome (STOP-FSS) Questionnaire|The STOP Questionnaire is a guided interview form that will be used to assess diagnosis, problems, treatments, and outcomes.
16232284|NCT01144741|Other|FSRG Semi-Structured Quality of Life Interview (FSRG SSQLI)|Completed after data analysis from the existing surveys, it will be a specific quality of life interview, taking into consideration individual's total health outcome.
16232285|NCT01144741|Other|Medical Records Review|Review of medical records will be used, along with STOP-FSS Survey to assess patient histories and outcomes.
16232286|NCT01144728|Drug|GLIMEPIRIDE + METFORMIN|Pharmaceutical form: Tablet Route of administration: oral Dose regimen : fixed dose combination of glimepiride / metformin: 1/250, 2/500
16232287|NCT01144715|Device|Hand Mentor (TM) robotic stroke therapy device|The goal of the Hand Mentor ™ (TM) device is to improve Active Range of Motion in the distal musculature of the paretic limb of patients with stroke. Development of HM patient protocols are based on basic principles of motor learning: the protocols actively engage the patient in activities, progressively increase task difficulty based on patient performance, actively assist patient if necessary (i.e. patient is not passive), provide meaningful feedback at regular intervals, require sensorimotor integration and incorporate the use of tasks that that are intended to transfer to distal motor performance.
16232288|NCT01144715|Device|Home Therapy Program|Subjects in the control group will be instructed in a self administered home therapy program
16232289|NCT01144702|Drug|artesunate & mefloquine combination|A therapeutic trial of a single arm for prospective evaluation of responses of individuals with uncomplicated malaria by P. falciparum treated with combination artesunate + mefloquine for three days and monitored clinically and biochemically for 42 days.
16232290|NCT01144689|Behavioral|Mindfulness Training|8 sessions of behavioral treatment for smoking cessation
16232291|NCT01144689|Behavioral|Smoking Cessation Therapy|8 sessions of behavioral treatment for smoking cessation
16232292|NCT01144676|Drug|dapivirine|"25mg dapivirine per ring.
~The first vaginal ring will be removed on Day 28, and a new vaginal ring will be reinserted after 3 days, on day 31, for another 28 days."
16232293|NCT01144676|Drug|placebo|The first vaginal ring will be removed on Day 28, and a new vaginal ring will be reinserted after 3 days, on day 31, for another 28 days.
16232294|NCT01144676|Drug|dapivirine|"25mg dapivirine per ring.
~The first vaginal ring will be removed on day 35 and the new vaginal ring will be reinserted after 3 days, on day 38, for another 21 days. A third vaginal ring will be inserted immediately following removal of second ring on Day 59 and will be worn for 24 hours."
16232295|NCT01144676|Drug|placebo|The first vaginal ring will be removed on day 35 and the new vaginal ring will be reinserted after 3 days, on day 38, for another 21 days. A third vaginal ring will be inserted immediately following removal of second ring on Day 59 and will be worn for 24 hours.
16232296|NCT01144663|Biological|Nimenrix™|4- or 3-dose intramuscular injection
16232297|NCT01144663|Biological|Menjugate®|3-dose intramuscular injection
16232298|NCT01144663|Biological|NeisVac-CTM|3-dose intramuscular injection
16232299|NCT01144663|Biological|Infanrix™ hexa|4-dose intramuscular injection
16232300|NCT01144663|Biological|Synflorix™|4-dose intramuscular injection
16232301|NCT01144650|Drug|Dapsone|Patients will receive either a single total dose of 250 mg dapsone or placebo IV and oral dosage
16232304|NCT01144637|Other|Placebo|0.5 ml TBS
16232305|NCT01144624|Drug|AZD9773|A single loading dose followed by 9 maintenance doses; doses to be given every 12 hours over a period of 5 days
16232306|NCT01144624|Drug|Placebo|Intravenous infusion of a saline solution
16232307|NCT01144611|Drug|bIAP bolus and 8h infusion|intravenous as a bolus of bIAP (bovine intestinal alkaline phosphatase, 1000 IU) just prior to surgery followed by a 40 IU/kg bIAP infusion during the first 8 hours post surgery.
16232308|NCT01144611|Drug|placebo bolus and 8h infusion|intravenous as a bolus just prior to surgery followed by an infusion during the first 8 hours post surgery.
16232309|NCT01144585|Procedure|remote ischemic preconditioning and postconditioning|"RIPC is done before the use of CPB. It consists of 4 cycles of 5 minutes inflation of pneumatic cuff to 200 mmHg and deflation for 5 minutes. RIPoC is exactly same procedure done after CPB."
16232310|NCT01144585|Procedure|Control|This group has same pneumatic cuff during the surgery, but it is not inflated during the surgery
16232311|NCT01144559|Procedure|Continuous Infusion|Extremity randomized continuous infusion will be given a peripheral nerve block and 5cc of Ropivacaine will be administered continuously every hour by a pain pump. Outcome measures will be tested.
16232312|NCT01144559|Procedure|Bolus Administered|Extremity randomized continuous infusion will be given a peripheral nerve block and 5cc of Ropivacaine will be administered using a bolus every hour by a pain pump. Outcome measures will be tested.
16232313|NCT01144546|Procedure|passive leg raising (45 degree leg elevation for 1-2 min)|the patient's trunk was elevated 45 degrees for the first set of measurements. Then, the lower limbs were raised to a 45° angle while the patient's trunk was lowered to a supine position to measure peak CO (usually within 1-2 min)
16232314|NCT01144533|Procedure|isotonic saline injection into the glenohumeral joint|"Total volume of injection drugs: 8ml
~isotonic saline 4ml + telebrix(contrast media) 4ml
~The number of injections : only once during the study period
~Injection site : glenohumeral joint
~Material : 22-gauze spinal needle
~Anteroposterior, lateral, and axial arthrography after injection was performed to determine accuracy and patterns of the injection."
16232315|NCT01144533|Procedure|steroid injection into the glenohumeral joint|"Total volume of injection drugs: 8ml
~triamcinolone(40mg)1ml + isotonic saline 3ml + telebrix(contrast media)4ml
~The number of injections : only once during the study period
~Injection Site : glenohumeral joint
~Material : 22-gauze spinal needle
~Anteroposterior, lateral, and axial arthrography after injection was performed to determine accuracy and patterns of the injection."
16232316|NCT01144533|Procedure|sodium hyaluronate injection into the glenohumeral joint|"Total volume of injection drugs: 8ml
~sodium hyaluronate 2ml + isotonic saline 2ml + telebrix(contrast media)4ml
~The number of injections : only once during the study period
~Injection Site : glenohumeral joint
~Material : 22-gauze spinal needle
~Anteroposterior, lateral, and axial arthrography after injection was performed to determine accuracy and patterns of the injection."
16232317|NCT01144533|Procedure|steroid and hyaluronate injection into the glenohumeral joint|"Total volume of injection drugs: 8ml
~triamcinolone(40mg)1ml + sodium hyaluronate 2ml + isotonic saline 1ml + telebrix(contrast media)4ml
~The number of injections : only once during the study period
~Injection Site : glenohumeral joint
~Material : 22-gauze spinal needle
~Anteroposterior, lateral, and axial arthrography after injection was performed to determine accuracy and patterns of the injection."
16232318|NCT01144507|Procedure|Abdominal Ultrasound|To establish eligibility and/or markers regarding echo pattern types.
16232319|NCT01144507|Other|Sample collection procedures|Samples of urine, serum, plasma, and blood for DNA from children and blood for DNA from parents will be requested from participating subjects
16232320|NCT01144494|Drug|Brimonidine|One drop of brimonidine in each eye three times a day for six weeks.
16232321|NCT01144494|Drug|Artificial tears|Lubricating drops added three times a day for six weeks
16232322|NCT01144455|Drug|Gemzar (Gemcitabine)|1,000 mg/m2 administered IV over 30 minutes on Days 1, 8 and 15 of a 28-day cycle.
16232323|NCT01144455|Drug|TH-302|240 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.
16232324|NCT01144455|Drug|TH-302|340 mg/m2 of TH-302 will be administered IV over 30 minutes on Days 1, 8 and 15 of every 28-day cycle.
16232325|NCT01144442|Drug|Hyperthermic intraperitoneal chemotherapy with Carboplatin|Carboplatin at a dose of 1000mg/m^2 will be added to the perfusate once circulating levels reach 1000-1500cc/minute. The circulation of the chemotherapy impregnated perfusate will be performed for 90 minutes.
16232326|NCT01144442|Other|Isotonic saline (perfusate)|The HIPC infusion will be performed with a closed abdomen technique. The perfusate will be isotonic saline heated to 40-42° Celsius.
16232327|NCT01144442|Procedure|Surgery|"The abdominal incision will be performed in a vertical fashion extending from the supra-pubic region to around the umbilicus.
~If cytoreductive surgery is required, it will be performed at this time and proceed in standard approach."
16232328|NCT01144442|Drug|Carboplatin|The scheduled systemic chemotherapy is paclitaxel 175mg/m2 and carboplatin AUC 6 every 3 weeks for 6 total cycles.
16232329|NCT01144442|Drug|Paclitaxel|The scheduled systemic chemotherapy is paclitaxel 175mg/m2 and carboplatin AUC 6 every 3 weeks for 6 total cycles.
16232330|NCT01144429|Biological|Allergoid, allergenic extract of 100% Birch|Subcutaneous injections Build-up = 1 day: 0,1mL + 0,2mL + 0,2mL s.c. in intervals on 30 minutes; Maintenance = 5 x single injection of 0,5 mL s.c. every 4 weeks
16232331|NCT01144416|Biological|SCH 900962 / Corifollitropin alfa / Org 36286|SCH 900962 will be provided as ready-for-use prefilled syringes containing 150 μg corifollitropin alfa per 0.5 mL. On day 2 or 3 of the menstrual cycle, a single dose of 150 μg corifollitropin alfa will be administered by subcutaneous injection in the abdominal wall in the morning.
16232332|NCT01144416|Biological|RecFSH / follitropin beta|RecFSH will be provided as a ready-for-use solution in 900 IU cartridges for subcutaneous injection with the Follistim Pen. Starting on day 2 or 3 of the menstrual cycle (=Stimulation Day 1), administration of recFSH will be done in the morning by daily injections in the abdominal wall. A starting dose of 300 IU will be administered and fixed for at least 7 days.
16232333|NCT01144416|Drug|Placebo for SCH 900962|"Supplied as a pre-filled syringe containing an identical solution when
~compared to SCH 900962, however without the active ingredient corifollitropin alfa. On Day 2 or 3 of the menstrual cycle (=Stimulation Day 1), a single dose of placebo SCH 900962 is to be administered in the morning by subcutaneous injection in the abdominal wall."
16232409|NCT01143727|Drug|Santyl|Apply one 24-hr period sufficient to cover the wound.
16232334|NCT01144416|Drug|Placebo for recFSH|Supplied as identical ready-for-use solution, but without the active ingredient, in cartridges for subcutaneous injection with the Follistim Pen. Starting on day 2 or 3 of the menstrual cycle (=Stimulation Day 1), administration of placebo-recFSH will be done by daily injections in the abdominal wall in the morning for a period of 7 days.
16232335|NCT01144403|Drug|Cyclophosphamide|as prescribed, 6 cycles
16232336|NCT01144403|Drug|Fludarabine|as prescribed, 6 cycles
16232337|NCT01144403|Drug|Mitoxantrone|as prescribed, 6 cycles
16232338|NCT01144403|Drug|Rituximab|375 mg/m^2 intravenously, Day 1 of each 28-day cycle, up to 8 cycles
16232339|NCT01144390|Behavioral|cognitive behavioral therapy|cognitive behavioral therapy, one session per week and psycho-education lecture in group once per month
16232340|NCT01144390|Drug|methadone maintenance treatment|methadone maintenance treatment
16232341|NCT01144377|Drug|LY2541546|Administered subcutaneously
16232342|NCT01144377|Drug|Placebo|Administered subcutaneously
16232343|NCT01144364|Drug|rituximab [Mabthera/Rituxan]|Intravenous repeating dose
16232344|NCT01144351|Drug|ELND002|
16232345|NCT01144351|Drug|Placebo|
16232346|NCT01144338|Drug|Exenatide Once Weekly|Subcutaneous injection, 2 mg, administered once weekly.
16232347|NCT01144338|Drug|Placebo|Subcutaneous injection, matching volume of placebo, administered once weekly.
16232348|NCT01144325|Procedure|thoracoscopic esophagectomy|"In prone position group, patients are intubated with single lumen endotracheal tube. Surgeon and assistant stand on the right of the patient. A 10 mm camera port is placed 7th intercostals space in posterior axillary line, CO2 pneumothorax is created with pressure of 8mmHg. A 5 mm port is placed just posterior to the scapular tip. The last 10mm port is placed at 9th intercostals space in the scapular line for. The tumor and esophagus are dissected with cleaning of the lymph nodes along bilateral recurrent nerve.
~In controlling group, The four chest ports were similar to that described by the University of Pittsburgh group. The left two ports are used for surgical exposure, the right two ports is to divide and dissect the esophagus. The dissection is similar to that of the prone position."
16232349|NCT01144312|Drug|Fentanyl|an initial intravenous bolus of fentanyl 100 μg and infusion of fentanyl at variable rates ranging from 250 to 400 μg/hr
16232350|NCT01144299|Biological|Fluarix™/Influsplit SSW®|Single intramuscular dose on Day 0
16232351|NCT01144286|Drug|arasertaconazole nitrate|Arasertaconazole nitrate pessary, placebo pessary
16232352|NCT01144286|Drug|placebo|placebo, single dose
16232353|NCT01144273|Procedure|Transversus abdominis plane block|"This intraabdominal approach to TAP block is being used regularly by gynaecological surgeons in this hospital now.
~To be performed bilaterally before surgical wound closure by an experienced surgeon who initially undergo initial observation by investigator to ensure uniformity in technique.
~Local anaesthetic or placebo solution will be injected to TAP with blunt needle from within abdominal cavity under visual and tactile guidance at the triangle of Petit, after feeling one 'pop' through the transversus abdominis muscle to the TAP layer.
~After careful aspiration to exclude vascular puncture, 1.5mg/kg of 0.5% ropivacaine or 0.3ml/kg of 0.9% saline placebo will be injected to each side slowly while observing for signs of toxicity."
16232354|NCT01144260|Drug|bafetinib|250 mg orally twice daily. Treatment continues until clinically significant disease progression or unacceptable toxicity is documented.
16232355|NCT01144247|Drug|alloreactive CTL|cellular immunotherapy with alloCTL
16232356|NCT01144234|Behavioral|Invitation letter for male spouse|In this arm the pregnant women got an invitation letter for the spouse to attend at the next antenatal visit
16232357|NCT01144234|Behavioral|Information letter|In this arm the pregnant women got an information letter
16232358|NCT01144221|Procedure|Intramyocardial Cell therapy|Intramyocardial Cell therapy in patients with chronic ischemic heart disease after ICD CRT Implantation
16232359|NCT01144195|Drug|Panitumumab + FOLFIRI|Panitumumab will be administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks. FOLFIRI chemotherapy will be administered once every 2 weeks after the administration of Panitumumab.
16232360|NCT01144182|Behavioral|Comprehensive quality improvement program (QIP)|Comprehensive quality improvement program (QIP) that intervenes on patient, provider and system levels. The QIP will consist of 3 monthly phone calls to promote diet and medication adherence using the transtheoretical model as a behavioral framework and checklists to facilitate patients' self-monitoring of their diet, physical activity, weight and medication taking. Further, providers during the posttest phase will use checklists for inpatient and outpatient care of HF patients.
16232361|NCT01144169|Drug|Hydroxychloroquine (HC)|Subjects will receive HC orally for 14 days prior to surgery. The fixed dose of HC will be 400 mg/day in divided doses (200 mg bid). The final dose will be administered on the evening prior to nephrectomy.
16232362|NCT01144156|Drug|Treatment with Adalimumab|All patients will receive SC adalimumab 160 mg at week 0, 80 mg at week 2 and 40 mg from week 4 every 2 weeks up to 12 weeks
16232363|NCT01144143|Drug|Infliximab|the study drug will be injected into the joint through a needle
16232364|NCT01144143|Drug|Placebo|the placebo will be injected into the joint through a needle
16232365|NCT01144143|Drug|Standard of Care: Methylprednisolone acetate|Methylprednisolone acetate will be injected into the joint through a needle
16232366|NCT01144117|Drug|Erythropoietin|Erythropoietin 48000 IU given I.V. in 17 courses
16232367|NCT01144104|Behavioral|Public Service Announcement|
16232368|NCT01144104|Behavioral|Interactive Multi-Media Computer Program|
16232369|NCT01144104|Behavioral|Sleep Hygiene Video|
16232370|NCT01144091|Drug|pentoxyphylline|pentoxyphylline tablets, 400 mg per tablet, 3 times a day one day before, on the day of the procedure and for another 48 hours.
16232371|NCT01144091|Drug|placebo|placebo tablets 3 times a day one day before, on the day of the procedure and for another 48 hours.
16232372|NCT01144091|Drug|pentoxiphylline|pentoxyphylline tablets, 400 mg per tablet, 3 times a day one day before, on the day of the procedure and for another 48 hours.
16232373|NCT01144091|Drug|placebo|placebo tablets 3 times a day one day before, on the day of the procedure and for another 48 hours.
16232410|NCT01143727|Drug|Tegaderm Hydrogel|Apply once 24-hr period sufficient to cover the wound.
16232411|NCT01143714|Drug|Santyl|Apply an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
16232374|NCT01144078|Behavioral|Traditional Intensity Exercise|The exercise intensity will be set at a workload corresponding to 40% of the workload obtained at VO2peak during the baseline progressive maximal exercise tests. Based on the anticipated fitness of the participants this should to an intensity of about 3.5 METs, which is similar to walking at a moderate pace.
16232375|NCT01144078|Behavioral|High Intensity Interval Exercise|The High Intensity Interval Exercise intervention will replicate all aspects of the Traditional Intensity Exercise with the exception of exercise intensity. The High Intensity Interval Exercise protocol will involve alternating between 1-minute intervals at 100% workload obtained at VO2peak followed by 3-minute recovery intervals at 20% of workload obtained at VO2peak (average = 40% ). As many complete intervals as possible will be completed during a training session (e.g., 7 intervals can be completed in a 30 min period (7 x 4 min = 28 min), with the remaining time spent at 40% peak workload to ensure a similar work output as the Traditional Intensity Exercise.
16232376|NCT01144065|Procedure|Hair sampling for the measurement of cortisol and testosterone|Hair sampling for the measurement of cortisol and testosterone
16232377|NCT01144052|Drug|interferon beta-1b|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 month at study entry. After a wash-out period of one month, interferon-beta-1b will be administered subcutaneously every other day as indicated by the manufacturers' instructions including the stepwise up-titration scheme as recommended for treatment start. The final dose of interferon beta-1b is 250 mcg (8 million International Units [MIU])
16232378|NCT01144052|Drug|Natalizumab|Eligible patients to this study have been treated with monthly infusions of natalizumab for at least 12 months at study entry. Natalizumab continues to be administered every four weeks by intravenous infusion from the beginning of the study as indicated by the manufacturers' instructions.
16232379|NCT01144039|Drug|LG-group|
16232380|NCT01144039|Drug|HG-group|
16232381|NCT01144039|Drug|Placebo-group|
16232382|NCT01144026|Biological|TUTI-16 (0.2mg)|Two subcutaneous injections of 0.2 mg at Day 0, and Week 5.
16232383|NCT01144026|Biological|TUTI-16 (1.0 mg)|Two subcutaneous injections of 1.0 mg at Day 0, and Week 5.
16232384|NCT01144000|Drug|Daptomycin|10mg/kg/24h i.v.(intravenous) for 2-3 weeks with/or without rifampin (depending if the prosthesis is removed or not)
16232385|NCT01143987|Drug|Cinacalcet|starting with 25 mg daily dose with titration, maximum dose 100 mg daily
16232386|NCT01143974|Drug|pemetrexed plus cisplatin|pemetrexed 500mg/m2 plus cisplatin 80mg/m2 on day1 of each 21 day cycle, until progression
16232387|NCT01143961|Device|CSC100 - Verso airway access adapter CareFusion|Following randomisation patients will have a one-way valve inserted into the ventilator circuit (CSC100 - Verso airway access adapter CareFusion) prior to a non-directed bronchoalveolar lavage (NBL) being performed. Changes in regional ventilation will be recorded by electrical impedance tomography during the NBL. Recordings of ventilation will take place for upto four hours. One-way valve will stay in place until ventilator circuit is changed.
16232388|NCT01143948|Drug|Glargine & Glulisine|Basal Glargine & bolus Glulisine
16232389|NCT01143948|Drug|Regular insulin|Sliding scale regular insulin
16232390|NCT01143948|Drug|NPH & regular insulin|Basal NPH & bolus regular insulin
16232391|NCT01143909|Other|omitting FFP transfusion before an intervention|In the interventional group FFP transfusion is omitted before performing a procedure (e.g. placement of central venous catheter, tracheostomy, chest tube)
16232392|NCT01143896|Other|Depression collaborative care model|The intervention will include a stepped-care model. The 5 steps include symptom and self-management monitoring by a depression care manager (DCM) and the following: 1) watchful waiting, 2) treatment recommendations (counseling or pharmacotherapy), 3) pharmacotherapy recommended by a Clinical Pharmacist, 4) combination pharmacotherapy and specialty mental health counseling, and 5) referral to mental health. The DCM: provides education about depression and depression treatment options; assesses the patient's treatment preferences and barriers, and the patient's current depression severity and mental health comorbidity; initiates a patient self-management plan, and assess treatment adherence. The DCM uses standard alcohol screening and brief intervention. The DCM also screens for street drug use and recommends referral for to the local substance abuse treatment programs.
16232393|NCT01143883|Other|Silverlon|Silverlon dressings are gauze impregnated with silver ions
16232394|NCT01143883|Other|Standard of Care Dressing|Standard dry gauze dressing
16232395|NCT01143870|Other|"Diabetes Report Card"|"Enrolled participants will receive an individualized diabetes report card which depicts their current level of diabetes control in one of three ways--hemoglobin A1C, face, or letter grade."
16232396|NCT01143857|Drug|Varenicline|Varenicline 2.0 mg/day or Placebo
16232397|NCT01143831|Dietary Supplement|Vitamin K, 20mg|Subjects will take 20mg vitamin K by mouth in capsule form everyday for 14 continuous days.
16232398|NCT01143818|Drug|AndroGel (testosterone gel) 1%|AndroGel is topical testosterone gel 1% and is prescribed for once daily use.
16232399|NCT01143805|Drug|Tasocitinib 10 mg oral tablet|Treatment A: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of an oral tablet
16232400|NCT01143805|Drug|Tasocitinib 10 mg IV Infusion|Treatment B: Single-dose of tasocitinib (CP-690,550) (10 mg) in the form of a 30 minute intravenous infusion
16232401|NCT01143792|Behavioral|Community Reinforcement Approach (CRA) + HIV prevention|12 sessions of the CRA and 2 sessions of HIV prevention.
16232402|NCT01143792|Behavioral|Case Management + HIV Prevention|12 sessions of case management and 2 sessions of HIV prevention.
16232403|NCT01143792|Behavioral|Motivational Enhancement Therapy (MET) + HIV prevention|2 sessions of MET and 2 sessions of HIV prevention.
16232404|NCT01143779|Drug|FLT-PET|FLT-PET scan uses the FLT solution (dosage of FLT in range between 1 and 10 mCi) with imaging performed 60-90 minutes after FLT intravenous injection.
16232405|NCT01143766|Drug|Gabapentin|gabapentin 900mg PO x 1 dose, 1 hour prior to the procedure
16232406|NCT01143766|Other|Standard sedation regimen|Combination opiate and benzodiazepine will be administered to achieve moderate sedation. This is the standard of care.
16232407|NCT01143753|Drug|RO5212054|Participants will receive RO5212054 at a starting dose of 200 milligrams (mg) orally once daily in each 21 day cycle. Dose levels for escalation will be decided based on the safety assessment of previous cohort. Dose escalations in increments of 50-100 percent are planned.
16232408|NCT01143740|Drug|RO5045337|orally day 1-10 each 28-day cycle, 3 cycles
16233318|NCT01136564|Drug|Placebo|2 capsules daily
16232412|NCT01143714|Other|White Petrolatum|Apply an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.
16232413|NCT01143701|Other|ADHD Collaborative|The ADHD Collaborative intervention model includes academic detailing, quality improvement methods, and innovative tools (e.g., web portal) designed to promote and support the systematic use of the AAP guidelines.
16232414|NCT01143688|Drug|albuterol|
16232415|NCT01143688|Drug|placebo inhaler|
16232416|NCT01143688|Procedure|placebo acupuncture|
16232417|NCT01143662|Drug|Ypeginterferon alfa-2b|sc, qw, for 48 weeks.
16232418|NCT01143662|Drug|Peginterferon alfa-2a|sc, qw, for 48 weeks.
16232419|NCT01143649|Device|transcranial direct current stimulation (tDCS)|Subjects will be stimulated at 1 mA for 40 minutes.
16232420|NCT01143649|Procedure|constraint induced movement therapy (CIMT)|
16232421|NCT01143649|Device|transcranial alternating current stimulation (tACS)|Subjects will be stimulated at 15Hz for 20 minutes.
16232422|NCT01143636|Device|Transcranial Direct Current Stimulation|Chronic pain subjects will be randomized to receive either active or sham stimulation for the duration of the trial. The subject will receive 10 consecutive sessions at an intensity of 2mA with each session lasting 20 minutes. If the subject receives active stimulation the current will be applied for the full 20 minutes, while in the sham group current will only be applied for 30 seconds. In the healthy cohort, subjects will receive one session of active stimulation and one session of sham stimulation. The parameters will be the same as the pain subjects, at an intensity of 2mA for 20 minutes.
16232423|NCT01143623|Dietary Supplement|Probiotic|L. acidophilus, L. paracasei, B. lactis; 2.5 billion cfu capsule once per day
16232424|NCT01143623|Dietary Supplement|Probiotic|L. acidophilus, L. paracasei, B. lactis; 10 billion cfu capsule once per day
16232425|NCT01143623|Other|Placebo|Placebo
16232426|NCT01143610|Procedure|Newly forming bone technique for root coverage|A granulation tissue will be obtained 21-25 days after the creation of an alveolar socket and grafted to receptor site.
16232427|NCT01143610|Other|Subepithelial connective tissue graft for root coverage.|A subepithelial connective tissue graft will be used for the treatment of Miller class I or II deep recessions.
16232428|NCT01143597|Other|Arm and hand training|Individuals will receive either: somatosensory stimulation isolated or combined with a skill-based exercise protocol, or a conventional strengthening program.
16232429|NCT01143584|Drug|Cabergoline|"In the Conventional escalation group Cabergoline 0.5 mg once a week for 4 weeks and further will be incrementally dose adjusted on the basis of individual PRL values until amelioration of hyper prolactinemia @ 0.5 mg/wk every 4 weeks, till 24 weeks or until primary endpoint.
~Cabergoline will be maintained at the dose at which PRL will be first normalized till primary end point."
16232430|NCT01143584|Drug|cabergoline|"In the Rapid escalation group schedule of cabergoline dosing will be as follows:
~Begin with 0.5 mg twice a week
~mg twice a week - second week 1.5 mg twice a week - third week
~mg twice a week - fourth week
~4mg/wk would be continued for next 4 weeks. If prolactin does not normalize by 8 weeks, a repeat hike in dose of 1mg/wk will be done every 4 weekly until normalization of prolactin levels and also >50% decrease in tumor volume. Ceiling dose of Cabergoline will be 12mg/wk."
16232432|NCT01143545|Biological|Allogeneic Tumor Cell Vaccine (K562)|Subcutaneous injection monthly for 6 months
16232433|NCT01143545|Drug|Celecoxib|400 g po bid
16232434|NCT01143545|Drug|cyclophosphamide|50 mg po bid
16232435|NCT01143441|Biological|DAC-HYP|
16232436|NCT01143402|Drug|Dacarbazine|Given IV
16232437|NCT01143402|Other|Laboratory Biomarker Analysis|Correlative studies
16232438|NCT01143402|Other|Quality-of-Life Assessment|Ancillary studies
16232439|NCT01143402|Drug|Selumetinib|Given PO
16232440|NCT01143402|Drug|Temozolomide|Given PO
16232441|NCT01143389|Drug|Riboflavin|Riboflavin 0.1% eye drops are applied before and during irradiation of the cornea.
16232442|NCT01143389|Device|UVX light|UVX 365 nm wavelength light source is applied with continued application of riboflavin.
16232443|NCT01143376|Behavioral|High intensity training|high-intensity intermittent sprinting (HIIS) (8 sec sprint:12 sec rest) for 12 weeks, 4 times a week
16232444|NCT01143376|Behavioral|short springs|short duration sprints (SDS)(8 sec sprint:12 sec rest) for 12 weeks, 4 times a week
16232445|NCT01143376|Behavioral|Moderate intensity exercise|
16232446|NCT01143363|Behavioral|resting - control|
16232447|NCT01143363|Behavioral|Moderate intensity exercise|
16232448|NCT01143363|Behavioral|High intensity intermittent training|
16232449|NCT01143363|Behavioral|Short sprint|
16232450|NCT01143350|Other|Bras A (EHPAD Training and stimulation)|"EHPAD of the group of Training / Stimulation will benefit:
~after a training in behaviours to be held or in methods of stimulation aiming at the reduction of disturbances of behaviour at type of apathy. This information will be transmitted in l 'ensemble of l 'équipe of l 'EHPAD by a training officer.
~of a structuring of the activities of animation offered to the inhabitants, This information will be regrouped in chips worked out like TNM - EHPAD."
16232451|NCT01143350|Other|EHPAD Control|EHPAD of the reference group, will have their habitual functioning
16232452|NCT01143337|Drug|MP-435(dose1) + Methotrexate|MP-435 dose1 + stable weekly dose of Methotrexate
16232453|NCT01143337|Drug|Placebo + Methotrexate|Placebo + stable weekly dose of Methotrexate
16232454|NCT01143324|Device|MAST™ procedure|Single or double level instrumented fusion receiving the CD Horizon® Spinal System using PLIF or TLIF techniques via a MAST™ procedure.
16232455|NCT01143311|Genetic|Arm A|"4 distinct biopsies will be taken
~in a non UV-exposed area (inner arm)
~in a UV-exposed area (external surface of the forearm)
~in a pretumoral region (actinic keratosis)
~inside the tumor"
16232456|NCT01143298|Drug|LEO 27847 oral solution|
16232495|NCT01142999|Drug|Control group|This group will be asked NOT to use any skin moisturizers and use only soap substitutes on their infants.
16232496|NCT01142999|Drug|Aquaphor ointment|One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants.
16232926|NCT01139697|Other|Hair sampling|Hair sampling for the measurement of cortisol and testosterone
16232457|NCT01143285|Other|Early and active nutritional support.|The first nutritional consultation coincides with the 1st CT consultation. An overview of the nutritional support strategy is given, along with specific goals and the twice monthly follow-up schedule that accompanies the chemotherapy courses. The nutritionist once again goes over the various side effects of the medication. Special attention will be given to digestive side effects and their consequences on appetite levels and weight loss during treatment.A qualitative and quantitative 3-day food record will precede the 1st course of CT. This food record is given to patients during the 1st selection visit, in order to evaluate spontaneous oral food intake and dietary habits. Information from the different food groups serves as a starting point for the dietician to explain how to adapt food intake through fortification, portion control according to appetite fluctuations and the onset of side effects.
16232458|NCT01143272|Drug|Saccharomyces boulardii|Units: 500 mg per day Route of administration : Oral Use Hard-Capsule
16232459|NCT01143272|Drug|Placebo|Placebo
16232460|NCT01143259|Drug|Alvimopam|The treatment group will receive 12mg of Alvimopan by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.12 mg by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days.
16232461|NCT01143259|Drug|300 mg Polyethylene|The control group will receive 300mg of polyethylene glyco by mouth 30 to 90 minutes before surgery and twice daily till discharge or to a maximum of 7 days (15 doses, total) after surgery.
16232462|NCT01143246|Drug|Terlipressin|Blinded terlipressin reconstituted with 5 mL of sterile 0.9% sodium chloride solution for injection will be administered intravenously as a slow bolus injection over 2 minutes at a dose of 1 mg (1 vial) every 6 hours (4 mg/day).
16232463|NCT01143246|Drug|Placebo|Lyophilized mannitol reconstituted with 5 mL of sterile 0.9% sodium chloride solution administered intravenously as a slow bolus injection over 2 minutes at a dose of 1 mg (1 vial) every 6 hours (4 mg/day).
16232464|NCT01143233|Other|control formula|infants are fed a commercial hydrolyzed formula
16232465|NCT01143233|Other|intervention formula 1|formula has hydrolysed protein and a different protein content
16232466|NCT01143233|Other|intervention formula 2|formula has hydrolysed protein, different protein content and pro- and prebiotics
16232467|NCT01143233|Other|intervention formula 3|formula has hydrolysed protein, different protein content and pro- and prebiotics
16232468|NCT01143220|Other|No specific interventions|Observational investigation, only procedures according to local hospital standard.
16232469|NCT01143207|Drug|Medroxyprogesterone acetate|Injectable hormonal contraceptive
16232470|NCT01143194|Dietary Supplement|oréVida™|1 capsule 30 mg oréVida™ twice a day (one in the morning, one in the afternoon, so in total 60 mg/day)
16232471|NCT01143194|Dietary Supplement|oréVida™|1 capsule 60 mg oréVida™ twice a day (one in the morning, one in the afternoon, so in total 120mg/day)
16232472|NCT01143194|Dietary Supplement|oréVida™|1 capsule 120 mg oréVida™ in the morning, one placebo capsule in the afternoon (si in total 120 mg/day)
16232473|NCT01143194|Dietary Supplement|Placebo|1 capsule of placebo twice a day
16232474|NCT01143181|Drug|Brincidofovir|Brincidofovir (BCV) was administered orally either once or twice weekly for up to 3 months. Treatment may have been extended for an additional 3 months depending a satisfactory review of safety parameters. Subjects could not receive more than a total of 6 months of treatment with BCV without prior approval.
16232475|NCT01143168|Biological|autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells|First Transplantation: after finishing all required examines according to protocol on Day 0, ABM-MNCs + UCMSCs are transplanted through pancreas artery percutaneously; Second Transplantation: after finishing all required examines on Day 7±1, BM-MNCs UCMSCs are transplanted intravenously; Third Transplantation: after finishing all required examines on Day 14±2, BM-MNCs + UCMSCs are transplanted intravenously.
16232476|NCT01143142|Behavioral|Computer-based tailoring system|Both the intervention and control groups will use a computer-based tailoring system to respond to survey questions. The computer-based tailoring system will produce messages for a two-page educational brochure based on participants' responses to survey questions. Only the intervention group will receive this brochure.
16232477|NCT01143129|Drug|Dexamethasone|Single dose (1 mg/kg) at start of cardiac surgical procedure
16232478|NCT01143129|Drug|Placebo|Placebo solution in a comparable amount to the experimental drug (0.05 mL/kg)
16232479|NCT01143103|Device|Cough assist (Philips,respironics)|
16232480|NCT01143103|Other|Usual respiratory therapy|
16232481|NCT01143090|Drug|Lurasidone HCl|40 mg Lurasidone tablets, 40 - 120 mg per day for up to 6 months
16232482|NCT01143077|Drug|Lurasidone HCl|Lurasidone tablets, 40 mg/daily, 80 mg/daily, 120 mg/daily for 6 weeks
16232483|NCT01143064|Drug|Progesterone|Intravenous administration of 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.
16232484|NCT01143064|Drug|Lipid emulsion without progesterone|Intravenous administration equal to 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.
16232485|NCT01143051|Drug|epinephrine inhalation aerosol|Single dose 220 mcg/inhalation, 10 inhalations
16232486|NCT01143051|Drug|epinephrine inhalation aerosol|HFA propelled epinephrine inhalation aerosol, 125 mcg/inhalation, 10 inhalations
16232487|NCT01143051|Drug|epinephrine inhalation aerosol|HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation, 10 inhalations
16232488|NCT01143038|Biological|Romiplostim|Romiplostim will be administered weekly by subcutaneous injection
16232489|NCT01143025|Drug|Ropivacaine 50 mg|Preoperative nebulization of 50 mg of Ropivacaine in the peritoneal cavity
16232490|NCT01143025|Drug|Ropivacaine 100 mg|Preoperative nebulization of 100 mg of Ropivacaine in the peritoneal cavity
16232491|NCT01143025|Drug|Ropivacaine 150 mg|Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity
16232492|NCT01143012|Other|Group eczema education session|Subjects in the intervention group will participate in a group education visit to discuss topics such as subjects' general understanding and knowledge of eczema and its treatment.
16232493|NCT01143012|Other|Control group|The control group will not attend the group eczema education session.
16232494|NCT01142999|Drug|Sunflower oil|One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants.
16232927|NCT01139684|Behavioral|Repeated sprint test|
16232497|NCT01142999|Drug|Cetaphil cream|One group will be instructed to use FDA-approved moisturizers and soap substitutes on their newborn infants.
16232498|NCT01142986|Behavioral|Low intensity care|During the first 3-months (13 weeks), subjects will be scheduled to attend one individual counseling session per month. Subjects will not be required to attend any group counseling sessions during this time. After the first 3-months of care, subjects will start usual counseling care, at which time they will be required to attend one individual counseling session per week, and may be required to attend additional individual and group counseling sessions each week for missed sessions or continued use of drugs or alcohol.
16232499|NCT01142986|Behavioral|Voucher reinforcement|Subjects will receive usual counseling care during the 26 weeks of study participation.They will be required to attend one individual counseling session per week, and will be required to attend additional individual and group sessions each week for missed session or continued use of drugs or alcohol.In addition, subjects in this condition will have the opportunity to earn voucher incentives each week during the first 13 weeks of care.These incentives can be earned by taking daily methadone doses and attending all scheduled counseling sessions (individual and group).The first voucher is worth $12.00, and each voucher after that is worth an additional $13.50. Bonuses of $30.00 will be awarded for each 3 consecutive weeks of compliance.The total amount possible to earn in the study is $1329.00. Each week that the subject is not compliant,they will not earn a voucher and the value of the next voucher will be reset to $12.00.The vouchers can be used for goods and services in the community.
16232500|NCT01142960|Dietary Supplement|Starch|1350mg/day
16232501|NCT01142960|Dietary Supplement|Lycium Barbarum|1350mg/day
16232502|NCT01142947|Drug|beclomethasone dipropionate|160 mcg twice a day (320 mcg per day total)
16232503|NCT01142934|Device|Transparent adhesive dressing with an integrated gel pad containing 2% w/w chlorhexidine gluconate (CHG) (TegaDerm CHG)|The intervention is represented by the combination of the TegaDerm transparent adhesive dressing with an integrated gel pad containing 2% w/w chlorhexidine gluconate (CHG), an antiseptic agent with broad spectrum antimicrobial and antifungal activity.
16232504|NCT01142921|Device|Anti-reflux Tannenbaum biliary stent|Anti-reflux Tannenbaum biliary stent
16232505|NCT01142921|Device|Ordinary Tannenbaum biliary stent|Ordinary Tannenbaum biliary stent
16232506|NCT01142908|Behavioral|Pharmacist CVD|clinical pharmacist-administered intervention which focuses on behavioral and medication management for 12 months.
16232507|NCT01142882|Behavioral|Traditional Prevention|Participants in the traditional prevention intervention condition will complete two sessions (of approx. one hour in duration) across the course of a week, conducted by a trained HIV (and infectious disease) prevention educator; these sessions will typically be conducted in small groups of 2-4 participants but may be offered individually.
16232508|NCT01142882|Behavioral|Web-based Prevention|Participants in the web-based intervention condition will complete an interactive, web-based HIV, hepatitis and STI prevention program. Youth will be asked to complete a customized plan of approximately 2-4 hours in length using the web-based tool; participants will complete two 60-minute sessions per week until they complete their customized plan. Participants can choose to access this intervention using dedicated computer stations set up at their substance abuse treatment setting or can complete these sessions at their own home via the web.
16232509|NCT01142869|Drug|Cetuximab|The starting dose will be intravenous (IV) cetuximab 400 mg/m2 body surface area administered as a 120-minute infusion once a week . The subsequent weekly doses will be IV cetuximab 250 mg/m2 administered as a 60-minute infusion. The maximum infusion rate must not exceed 10 mg/min.
16232510|NCT01142856|Biological|autologous mesenchymal stem cells|single intrathecal dose of 10x6 cells by lumbar puncture.
16232511|NCT01142843|Drug|green propolis mouthwash|The subjects were instructed to brush their teeth as usual and to rinse with the 10mL of Mouthwash contain 5% Green Propolis, twice a day, for one minute, right after their meals in the morning and at night. The treatment was performed during three months
16232512|NCT01142804|Behavioral|Group|Walking programs with various levels of support will be administered to determine which one is most effective.
16232513|NCT01142791|Device|ExAblate|Magnetic resonance image-guided focused ultrasound (MRgFUS) for fibroid ablation
16232514|NCT01142778|Drug|Bevacizumab|Bevacizumab at a dose of 15 mg/kg will be administered as IV infusion over 90 minutes from Cycles 3-6 (1 Cycle=21 days).
16232515|NCT01142778|Drug|Docetaxel|Docetaxel at a dose of 100 mg/m^2 will be administered as IV infusion from Cycles 1-6 (1 Cycle=21 days).
16232516|NCT01142778|Drug|Trastuzumab|Trastuzumab will be administered as a loading dose of 8 mg/kg as IV infusion in Cycle 1, followed by subsequent dose of 6 mg/kg as IV infusion in Cycles 2 to 7, and during additional 11 cycles post surgery (1 Cycle=21 days).
16232517|NCT01142778|Procedure|Surgery|All participants will undergo surgery (as per investigator's discretion) after Cycle 7 and between 4 and 6 weeks after the study treatment infusion in Cycle 6 (1 Cycle=21 days).
16232518|NCT01142778|Radiation|Radiotherapy|All participants will receive radiotherapy starting about 4 to 8 weeks after surgery, and will last around 4 to 6 weeks as per site's standard practice.
16232519|NCT01142778|Drug|Hormonal Therapy|Participants who are hormone receptors positive, will receive hormonal therapy after completion of radio therapy period as per investigator's discretion and site's standard practice.
16232520|NCT01142765|Biological|AdCh63 MSP1, MVA MSP1, challenge|1 dose of AdCh63 MSP1 5 x 1010 vp intramuscularly and 1 dose MVA MSP1 2.5 x 108 pfu intramuscularly 8 weeks later (range 6-12 weeks) followed by sporozoite challenge 12-28 days later
16232521|NCT01142765|Biological|AdCh63 AMA1, MVA AMA1, challenge|1 dose of AdCh63 AMA1 5 x 1010 vp intramuscularly and 1 dose MVA AMA1 2.5 x 108 pfu intramuscularly 8 weeks later (range 6-12 weeks) followed by sporozoite challenge 12-28 days later
16232522|NCT01142765|Biological|AdCh63 AMA1, AdCh63 MSP1, MVA AMA1, MVA MSP1, challenge|1 dose of AdCh63 AMA1 5 x 1010 vp intramuscularly and 1 dose AdCh63 MSP1 5 x 1010 vp intramuscularly co-administered into separate arms followed 8 weeks later (range 6-12 weeks) by 1 dose of MVA AMA1 2.5 x 108 pfu intramuscularly and 1 dose MVA MSP1 2.5 x 108 pfu intramuscularly co-administered into separate arms (but the same arm as the corresponding AdCh63 vaccine) followed by sporozoite challenge 12-28 days later.
16232615|NCT01142128|Drug|Nexium (esomeprazole magnesium)|one 40 mg capsule per day for one month
16232616|NCT01142128|Drug|Placebo to Nexium|one capsule per day for one month
16232679|NCT01141660|Device|Laryngeal mask airway|Randomized to either Laryngeal mask airway or endotracheal tube
16232523|NCT01142765|Biological|AdCh63 MSP1, AdCh63 ME-TRAP, MVA MSP1, MVA ME-TRAP, challenge|1 dose of AdCh63 MSP1 5 x 1010 vp intramuscularly and 1 dose AdCh63 ME-TRAP 5 x 1010 vp intramuscularly co-administered into separate arms followed 8 weeks later (range 6-12 weeks) by 1 dose of MVA MSP1 2.5 x 108 pfu intramuscularly and 1 dose MVA ME-TRAP 2 x 108 pfu intramuscularly co-administered into separate arms (but the same arm as the corresponding AdCh63 vaccine) followed by sporozoite challenge 12-28 days later.
16232524|NCT01142765|Biological|Sporozoite challenge|Non-vaccinated controls for sporozoite challenge
16232525|NCT01142739|Other|Clinical variables|Demography, disease duration, treatment duration, current treatment, daily intake of levodopa, Disease stage (Hoehn and Yahr, HY), motor score (UPDRS III) and dyskinesia severity (UPDRS IV). Biological variables.
16232526|NCT01142739|Other|Clinical variables|Demography, Biological variables.
16232527|NCT01142739|Other|Clinical variables|Eye movement recordings : non-invasive infra-red camera oculometry (EyeBrain) before and after (only parkinson's disease group) levodopa(10 to 15 minute/recording)
16232528|NCT01142726|Drug|Abatacept|Injection, subcutaneous, 125 mg by syringe, once weekly, 12 months
16232529|NCT01142726|Drug|Methotrexate|Tablets, oral, 2.5 mg, once weekly, 12 months
16232530|NCT01142726|Drug|Abatacept placebo|Injection, subcutaneous, to match 125 mg by syringe, once weekly, 12 months
16232531|NCT01142726|Drug|Methotrexate placebo|Tablets, oral, to match 2.5-mg tablet, once weekly, 12 months
16232532|NCT01142713|Radiation|Patient Position During Radiotherapy|Two simulations, one in the supine position on a flat table and another in the prone position on belly board
16232533|NCT01142700|Drug|BMS-824393|Capsule, Oral, 10 mg, once daily
16232534|NCT01142700|Drug|BMS-824393|Capsule, Oral, 30 mg, once daily
16232535|NCT01142700|Drug|BMS-824393|Capsule, Oral, 100 mg, once daily
16232536|NCT01142700|Drug|Placebo|Capsule, Oral, 0 mg, once daily
16232537|NCT01142700|Drug|Peginterferon Alpha-2a|Syringe, subcutaneous 180 mcg/0.5 mL, weekly
16232538|NCT01142700|Drug|Ribavirin|Tablet, Oral, 400 or 600 mg based on weight (am) and 600 mg (pm), twice daily
16232539|NCT01142687|Dietary Supplement|dihydrocapsiate capsule|"Group 1: 1 dihydrocapsiate capsule and 2 placebo capsules three times a day within 30 minutes before breakfast, lunch and dinner.
~Group 2: 3 dihydrocapsiate capsules three times per day within 30 minutes before breakfast, lunch and dinner
~Group 3: Placebo 3 capsules three times per day within 30 minutes before breakfast, lunch and dinner"
16232540|NCT01142661|Drug|Eribulin Mesylate|Eribulin Mesylate: A dose of 1.4 mg/m^2 given intravenously on Day 1 and Day 8 of a 21 day cycle, continued until disease progression, unacceptable toxicity or death.
16232541|NCT01142648|Drug|Sugammadex|Sugammadex 200 mg iv, single dose, bolus.
16232542|NCT01142648|Drug|Neostigmine and glycopyrrolate|Neostigmine 2.5 mg and glycopyrrolate 0,5 mg, iv, single dose, bolus, diluted in 2 ml volume with saline
16232543|NCT01142635|Drug|Rocuronium bromide|Rocuronium, iv, 0,6 mg/kg diluted with saline to double volume, bolus, single dose
16232544|NCT01142635|Drug|Rocuronium bromide|Rocuronium, iv, single dose, single bolus, 1.2 mg/kg
16232545|NCT01142622|Drug|Ropivacaine nebulization|Preoperative nebulization of 150 mg of Ropivacaine in the peritoneal cavity.
16232546|NCT01142622|Drug|Ropivacaine instillation|Preoperative instillation of 150 mg of Ropivacaine in the peritoneal cavity.
16232547|NCT01142609|Behavioral|eGet|eGet individual counseling sessions from home will be scheduled weekly for 12 weeks.
16232548|NCT01142596|Drug|Asenapine|Asenapine 5 mg sublingual tablet BID, Asenapine 10 mg sublingual tablet BID
16232549|NCT01142596|Drug|Placebo|Placebo sublingual tablet BID (first 2 weeks, participants who were in placebo arm of P06124 study only)
16232550|NCT01142570|Other|Caloric Support (Group 1)|Four group 1-dose of caloric support will be calculated by Hariss-Benedict Formula measurement of Resting Energy Expenditure(REE).
16232551|NCT01142570|Other|Caloric Support (Group 2)|For group 2- dose of caloric support will be calculated by Indirect Calorimetric measurement of Resting Energy Expenditure(REE)
16232552|NCT01142570|Dietary Supplement|Protein dose of 1.1 to 1.5 grams per kilogram weight.|Patients in the first group(Group 1A) will receive caloric support calculated by the HARRISS BENEDICT equation and protein dose of 1.1 to 1.5 grams per kilogram weight.
16232553|NCT01142570|Dietary Supplement|Protein at 1.1 grams per kilogram weight.|Patients in the second group(Group 2A) will receive caloric support as measured by indirect calorimetry and will receive protein at 1.1 grams per kilogram weight.
16232554|NCT01142570|Dietary Supplement|protein at a dose of 1.5 grams per kilogram weight.|Patients in the third group (Group 3A) will receive caloric support as measured by indirect calorimetry and will receive protein at a dose of 1.5 grams per kilogram weight.
16232555|NCT01142557|Drug|Interferon beta-1a (Rebif)|A dosage of 44 µg or 22 µg interferon beta-1a (Rebif) as subcutaneous self-injection three times a week was recommended for therapy of the included, suitable MS subjects after a creep-in phase of 4 weeks.
16232556|NCT01142544|Other|Evaluation oxygenation under standard ventilator settings|Measure of PaO2 under standard FiO2-PEEP
16232557|NCT01142531|Radiation|Chest CT scan|"Supine CT scan after full inspiration. Acquisition parameters: (Topogram 35 mA 120 kV 512 mm length)
~90 quality ref mAs with care-dose ON
~120 kV
~Pitch 1.4
~Rotation time 0.33 s
~Acquired images 64 x 0.6 mm"
16232558|NCT01142518|Drug|Interferon beta 1a|Interferon beta 1a was administered at a dose of 44 μg x 3 as a subcutaneous self-injection.
16232559|NCT01142505|Drug|Mannitol|4mg once daily granules for 10 days, given orally alone or with cold or warm food from the onset of a cold or wheezing attack.
16232560|NCT01142505|Drug|Montelukast|4mg once daily granules for 10 days, given orally alone or with cold or warm food from the onset of a cold or wheezing attack
16232561|NCT01142492|Drug|Interferon beta-1a|Subjects first received Interferon beta-1a at a dose of 22 µg x3 over a period of 4 weeks. An attempt was then made to increase the dose of interferon beta-1a to 44 µg x3 as a self-administered subcutaneous (s.c.) injection. If intolerable interferon-specific side effects or problems of acceptance occured, the treatment with Rebif 22 µg three times weekly was continued.
16232562|NCT01142479|Drug|Chinese herbal medicine decoction|100 ml /Qd for 6 weeks(42 days)
16232617|NCT01142128|Drug|Viokase 16 (pancrelipase) + Nexium|Viokase 16 (pancrelipase) + Nexium capsules are given per day for one month with the addition of esomeprazole magnesium, one 40mg capsule per day for one month
16232563|NCT01142466|Drug|Interferon beta-1a (Rebif)|The dosage of IFN-beta-1a , following initial dose titration, was 44 mcg injected subcutaneously (s.c.) tiw. An auto-injector device, Rebiject, was available as an optional aid for the administration of IFN-beta-1a . IFN-beta-1a was administered, if possible, at the same time (preferably in the late afternoon or evening) on the same three days at least 48 hours apart each week.
16232564|NCT01142453|Drug|Interferon beta 1a|A dosage of 44 µg interferon beta 1a subcutaneous self-injection three times a week was recommended for therapy of the included, suitable MS subjects after a creep-in phase (depending on the respective preliminary therapy)
16232565|NCT01142440|Behavioral|behavioral intervention|"Dietary instructions
~Oral hygiene instructions: GC plaque indicator kit
~Antibacterial therapy: medident sol. one week a month, for 6 months
~Fluorides: VOCO Profluorid varnish, once every 3 month
~Restoration
~Follow ups"
16232566|NCT01142427|Other|Cytology Specimen Collection Procedure|Correlative studies
16232567|NCT01142427|Other|Laboratory Biomarker Analysis|Correlative studies
16232568|NCT01142414|Biological|panitumumab|
16232569|NCT01142414|Drug|cisplatin|
16232570|NCT01142414|Drug|fluorouracil|
16232571|NCT01142414|Other|laboratory biomarker analysis|
16232572|NCT01142414|Procedure|adjuvant therapy|
16232573|NCT01142414|Procedure|quality-of-life assessment|
16232574|NCT01142414|Radiation|3-dimensional conformal radiation therapy|
16232575|NCT01142414|Radiation|intensity-modulated radiation therapy|
16232576|NCT01142401|Drug|Bortezomib|Given IV
16232577|NCT01142401|Drug|Fulvestrant|Given IM
16232578|NCT01142401|Other|Laboratory Biomarker Analysis|Correlative studies
16232583|NCT01142362|Biological|VGX-3400X|DNA plasmids delivered via IM injection + electroporation using CELLECTRA device
16232584|NCT01142349|Behavioral|Lifestyles A|Six weekly group sessions that last about 90-120 minutes presenting cognitive behavioral therapy for pain and insomnia
16232585|NCT01142349|Behavioral|Lifestyles B|Six weekly group sessions that last about 90-120 minutes presenting cognitive behavioral therapy for pain.
16232586|NCT01142349|Behavioral|Lifestyles C|Six weekly group sessions that last about 90-120 minutes presenting osteoarthritis education.
16232587|NCT01142336|Drug|Simvastatin|Simvastatin 40mg qHS for 1 year
16232588|NCT01142336|Drug|Placebo|Placebo 1 tablet qHS for 1 year
16232589|NCT01142323|Drug|fenofibrate|160 mg po daily
16232590|NCT01142310|Drug|Lamotrigine|Lamotrigine will be initiated at 25 mg/day and upwardly titrated to a dose of 400 mg/day over 10 weeks.
16232591|NCT01142310|Drug|Placebo|
16232592|NCT01142297|Device|dental implant and modified dental implant|standard SLA surface and chemically modified surface
16232593|NCT01142284|Drug|Cilostazol, Probucol|"Treatment Group 1 (control) No cilostazol or probucol
~Treatment Group 2 (cilostazol alone) 1 tablet cilostazol 100 mg PO BID
~Treatment Group 3 (probucol alone) 1 tablet probucol 250 mg PO BID
~Treatment Group 4 (concomitant cilostazol and probucol) 1 tablet cilostazol 100 mg PO BID, and 1 tablet probucol 250 mg PO BID"
16232594|NCT01142271|Procedure|Billroth-I|Standard distal gastrectomy with D1 plus beta or D2 lymph node dissection would be performed for distal gastric cancer. After that, gastroduodenostomy should be performed by circular stapler. In addition, stapler sites were re-enforced.
16232595|NCT01142271|Procedure|Roux en Y|Standard distal gastrectomy with D1 plus beta or D2 lymph node dissection would be performed for distal gastric cancer. After that, jejunojejunostomy and gastrojejunostomy should be performed by circular staplers. In addition, stapler sites were re-enforced.
16232596|NCT01142258|Drug|Trazodone|Trazodone tablets, 50 mg, 10pm (before bedtime) for 14 days.
16232597|NCT01142258|Drug|Placebo|Inactive or inert pill which will be used as a comparator
16232598|NCT01142245|Drug|Oral esomeprazole|• Oral Esomeprazole 40mg on Day 1, 2 and Day 3 q12h
16232599|NCT01142245|Drug|Intravenous Esomeprazole|"Esomeprazole IV 80mg loading bolus
~Esomeprazole intravenous infusion 8mg/hr for 72 hours"
16232600|NCT01142232|Drug|Lenalidomide plus Melphalan during autologous stem cell transplantation|Patients will receive a fixed dose of melphalan, while the dose of lenalidomide is escalated according to the protocol defined cohorts. Lenalidomide is given on day -7 to day +2, while intravenous melphalan is given on day -2 and -1. Lenalidomide dosing will be in the morning at approximately the same time each day.
16232601|NCT01142232|Drug|Lenalidomide maintenance|Lenalidomide maintenance therapy will begin on Day +100 to Day +110 provided the protocol-defined criteria are met. The initial starting dose of lenalidomide during maintenance is 10 mg daily on Days 1-28 of each 28-day cycle.
16232602|NCT01142219|Drug|L-arginine|L-arginine was administered orally at a dose of 0.1g/kg/day during 6 months.
16232603|NCT01142219|Drug|Placebo|Mannitol was administered orally at a dose of 01 g/kg/day for six months.
16232604|NCT01142206|Behavioral|Dietary|All participants in the investigation will receive a standard 8-week behavioral obesity intervention with 8 weekly, 1 hour group counseling and education sessions. The intervention will include a reduced caloric prescription (1200-1500 kcal/day) and fat gram prescription (30% or less kcals from fat).
16232605|NCT01142206|Behavioral|Physical Activity|All participants will receive a physical activity goal of 200 minutes/week of moderate-intense physical activity.
16232606|NCT01142206|Behavioral|TV Watching + Physical Activity|The TV Watching + physical activity arm will receive a TV watching goal of watching less than 10 hours of TV/week.
16232607|NCT01142193|Drug|USL255|
16232608|NCT01142193|Drug|Placebo|
16232609|NCT01142180|Procedure|TAE|The procedure will be performed within 12 hours of endoscopic therapy. This is usually performed under conscious sedation
16232610|NCT01142180|Procedure|No TAE|No TAE procedure will be performed after endoscopic treatment
16232611|NCT01142167|Procedure|Standard Colonoscopy|Standard colonoscopy will be used during colonoscopy
16232612|NCT01142167|Procedure|Ultra-thin colonoscopy|Ultra-thin colonoscope will be used during colonoscopy
16232613|NCT01142154|Drug|Prodarsan|Prodarsan TID, oral solution, 6-8 days
16232614|NCT01142141|Other|manual therapy, kinesiotherapy|
16232618|NCT01142128|Drug|Viokase 16 + placebo to Nexium|Viokase 16 pancrelipase tablets are given per day for one month with one capsule of placebo to esomeprazole magnesium, one per day for one month
16232619|NCT01142115|Device|Intermittent catheter CP063CC|intermittent catheterisation
16232620|NCT01142115|Device|SpeediCath|intermittent catheterisation
16232621|NCT01142102|Radiation|Radiation Therapy|"A radical dose of radiotherapy to be delivered to the entire bladder volume: 64Gy in 32 fractions over 6 weeks and 2 treatment days.
~Conventional plan is used to deliver treatment for fractions 1 to 7 using a standard planning approach and a CTV to PTV margin of 1.5cm.
~Adaptive plan is used to deliver treatment for fractions 8 through 32 using the same standard techniques as for fractions 1 to 7 but using one of three specific CTV volumes,namely: small, average or large. In all these cases the CTV to PTV margin is 0.7cm. Image guidance using a treatment unit based verification CT unit (Cone Beam CT or CT on Rails)based on soft tissue delineation is used to position the treatment fields and select the plan to best cover the CTV."
16232622|NCT01142089|Drug|Placebo|Placebo (two matching tablets) orally twice daily for 3 days (72 hours).
16232623|NCT01142089|Drug|Rifamycin SV MMX|Rifamycin SV MMX® 400 mg (two 200 mg tablets) orally twice daily for 3 days (72 hours).
16232624|NCT01142076|Drug|Xinju Xiaogao Prescription|treatment group
16232625|NCT01142076|Drug|placebo|Therapeutic dose of 10%
16232626|NCT01142063|Drug|Neratinib|Tablet, a 240 mg single oral dose
16232627|NCT01142063|Drug|Neratinib|Tablet, a 240 mg single oral dose
16232628|NCT01142063|Drug|Neratinib|Tablet, a 240 mg single oral dose
16232629|NCT01142063|Drug|Neratinib|Tablet, a 240 mg single oral dose
16232630|NCT01142050|Biological|mesenchymal stem cells|1.1st transplantation: after finishing all required examines according to protocol in Day 0, ABM-MSCs are transplanted through pancreas artery percutaneously; 2. 2nd transplantation: after finishing all required examines in Day 7±1, BM-MSCs are transplanted intravenously; 3. 3rd transplantation: after finishing all required examines in Day 14±2, BM-MSCs are transplanted intravenously.
16232631|NCT01142037|Dietary Supplement|Cooked parsnips with parsley|Beginning on Day 9 participants will be given cooked parsnips with parsley at a dose of 2 grams total apiaceous vegetable/kilogram body weight for period 1, and 4 gram/kilogram body weight for period 2.
16232632|NCT01142024|Drug|Glutathione|NS 500ml + Glutathione 1.8g intravenously guttae 1-1.5ml/kg per hour,30 minutes before and during coronary angiography
16232633|NCT01142024|Drug|saline|NS 500ml intravenously guttae 1-1.5ml/kg per hour,30 minutes before and during coronary angiography
16232634|NCT01142011|Drug|Belimumab|"The first cycle of Belimumab (10mg/kg by intravenous (IV) infusion) is a loading cycle of 3 doses over 28 days (days 1, 15, 29). After the first cycle, additional cycles of belimumab (10mg/kg by intravenous (IV) infusion) will be administered every 28 ± 1 days (cycle 2 and all subsequent cycles).
~The infusion will be administered over a minimum period of 1 hour."
16232635|NCT01141998|Drug|Calcium, Dietary|400 mg calcium two times daily. From week 0 to 10 and week 14 to 52.
16232636|NCT01141998|Drug|Cholecalciferol|38 micrograms daily. Week 0-10.
16232637|NCT01141998|Radiation|UVB|Ultraviolet radiation type B administered in a tanning bed. One time weekly.
16232638|NCT01141998|Radiation|UV-filtered light.|Light from a tanning bed but a UV-filter stops all ultraviolet radiation. One time weekly.
16232639|NCT01141998|Drug|Cholecalciferol|38 micrograms daily. From week 14 to 52.
16232640|NCT01141985|Device|LenSx Laser modified disposable contact lens|Modified Disposable Contact Lens Patient Interface: Like the current disposable contact lens, a single unit is used for each procedure only once, and is then discarded. It is similarly mounted onto the distal end of the system's focusing objective and serves as a sterile barrier between the patient and the laser. In place of a separate suction ring that is used in the current contact lens, the modified contact lens has an integrated suction ring and curved applanation surface. These features result in significantly lower elevation of intraocular pressure and significantly easier application by the surgeon in preliminary testing. Identical to the current contact lens, the suction ring is applied around the patient's limbus and mild suction is applied to stabilize the eye.
16232641|NCT01141972|Dietary Supplement|Vitamin D|We will administer 100,000 IU Vitamin D3 orally as an observed 1-time bolus and then prescribe 1000 IU by mouth daily. These doses have achieved sufficiency in other populations.99, 100 We will use the level of sufficiency (≥30 ng/ml [≥75 nmol/L]) that is recommended by most experts in the field.89-91, 93, 95, 96, 101-105 We will repeat the bolus at 1 month if the target level is not achieved. The control group will receive matching placebo and a similar proportion will go through a dummy titration. All women consuming less than 800 mg/day of calcium (by dietary history) will receive 500 mg of calcium to ensure sufficiency.
16232642|NCT01141972|Other|Placebo|Current standard of practice does not dictate that otherwise healthy early menopausal women have Vitamin D levels evaluated. Women with Vitamin D levels between 10 and 29 ng/ml who receive placebo will be receiving usual care (i.e., no additional Vitamin D repletion above intake at the time of screening).
16232643|NCT01141946|Procedure|thoracic ultrasound|All patients will receive pre-operative pleural-based ultrasound during their initial consultation.
16232644|NCT01141946|Procedure|pleural aspiration|Before proceeding to pleural aspiration, a radiography of the chest will be performed in order to ascertain the presence of a pleural effusion.
16232645|NCT01141933|Other|Cognitive-existential intervention|Over the past 2 years we developed a 12-week cognitive-existential intervention consisting of 12 modules. The first three modules essentially involve cognitive and behavioral techniques proposing reinforcement of the use of active behavioral (e.g., relaxation, activation) and emotional (cognitive reframing) strategies. This content comes from classical cognitive-behavioral techniques. The next 3 modules, inspired by empirically-tested interventions further explore emotional strategies. The last six modules specifically address the existential dimension. They are adapted from logotherapy techniques, which are also empirically-based, and have been adapted to a French-Canadian culture by our team. They aim to improve meaning-based and emotional coping strategies.
16232646|NCT01141933|Other|Usual care|This group receive the usual treatment only.
16232647|NCT01141920|Behavioral|low threshold care|Low threshold care refers to a service delivery method that reduces the treatment demands for new admissions to substance abuse treatment. In the present study, participants will be scheduled to attend less counseling sessions, and will have greater access to methadone.
16233661|NCT01133925|Device|Zotarolimus eluting stent|Endeavor stents implanted in overlap
16232648|NCT01141920|Behavioral|stepped-based care|Stepped-based care is routine treatment at ATS. Participants begin a low intensity care, and are advanced to more intensive levels of care (i.e., more intensive schedules of counseling) based on urine samples and counseling adherence.
16232649|NCT01141907|Behavioral|Heart Failure Self Care Support|The intervention is aimed at preventing HF exacerbations and hospitalizations by improving self management with the support of the Home Automated Telemonitoring (HAT) system. The intervention was delivered by a RN-community health navigator (CHN) team over three months to HF patients and their caregivers in their home and via telephone and HAT system. The intervention was initiated during the index hospitalization. The RN-CHN team collaborated with participants, caregivers, and their usual source of HF care. Intervention strategies included tracking of weight and HF symptoms to provide feedback regarding self management and plan of care, enhancing medication and symptom self management, promoting HF care follow up, and promoting communication with providers.
16232650|NCT01141907|Other|Usual heart failure care|Participants assigned to usual care are treated by their usual source of HF care in the usual manner and in accordance with the American College of Cardiology/American Heart Association Guidelines for the management of HF. Usual care for HF patients admitted to Johns Hopkins Hospital also includes the following: 1) Referral to HF clinic if the patient has no usual source of care and 2) HF patient education booklet.
16232651|NCT01141894|Other|Goal directed haemodynamic treatment|Treatment by fluids and Dobutamine to attain fixed haemodynamic goal
16232652|NCT01141894|Other|Routine fluid treatment|Protocol guided fluid treatment used in the clinical routine
16232653|NCT01141881|Drug|Tissue Plasminogen Activator,bevacizumab ,follow up|25 microgram in 0.05 cc,1.25 mg in 0.05 cc,nothing
16232654|NCT01141868|Behavioral|Internet Intervention|online treatment for insomnia
16232655|NCT01141855|Drug|Champix|"Standard MIMS dosage (including period of titration) will be used. 0.5mg daily for 3 days 0.5mg b.d. for 4 days
~1mb b.d. for 70 days (full course 3 months)"
16232656|NCT01141855|Behavioral|Counselling alone|Quit SA 5A counselling over the phone. Maximum 8 calls over a 3 month period
16232657|NCT01141842|Procedure|exhalation analysis of breath sample|breath sample is presented to sniffer dog in test tube
16232658|NCT01141842|Procedure|exhalation analysis of breath sample|breath sample is presented to sniffer dog in test tube
16232659|NCT01141842|Procedure|exhalation analysis of breath sample|breath sample is presented to sniffer dog in test tube
16232660|NCT01141816|Other|Contrast-Enhanced Ultrasound|Contrast-enhanced ultrasounds of the kidney will be performed within 7 days of routine CTs or MRIs at 3, 6, 12, 18, and 24 months post-radiofrequency ablation, with Perflutren Lipid Microsphere Injectible Suspension ('Definity') as the contrast agent.
16232661|NCT01141803|Dietary Supplement|Apples|550g of apples/day
16232662|NCT01141803|Dietary Supplement|Apple pomace|22g apple pomace/day
16232663|NCT01141790|Other|Music and voice message|
16232664|NCT01141777|Dietary Supplement|Spirulina platensis|Subjects received 19g daily of supplement averagely.This was supplied as powder daily, in packs that lasted for 2weeks each. Each subject was therefore seen every two week to obtain new stock of supplements and evaluate compliance
16232665|NCT01141777|Dietary Supplement|Soya bean|Each subject received 19g of supplement on average daily. Subjects were seen every two weeks to evaluate compliance and obtain a new stock.
16232666|NCT01141764|Procedure|Positron Emission Tomography (PET) Scan|"The PET procedure consists of an intravenous injection of 18F-FDG followed by a 45-minute period of quiet resting. PET images will be acquired on an integrated PET/CT scanner.
~This process will be repeated with the stimulator on during the first PET image acquisition and off during the second PET image acquisition. On and off PET image acquisitions will be performed on two separate days."
16232667|NCT01141764|Procedure|Magnetic Resonance Imaging (MRI)|MRI will be performed on a 1.5T system, using a combination of different sequences including sagittal T1, coronal and axial T2, FLAIR and proton density and axial 3D T1 weighted images.
16232668|NCT01141764|Other|Neuropsychological Testing|"On the same day or separate visit, depending on the timing of the PET imaging, they will be required to attend one half-day session for neuropsychological testing. Patients will arrive at the Toronto Western Hospital, the stimulator will be turned off for 30 minutes prior to neuropsychological testing with testing repeated with the stimulator on."
16232669|NCT01141738|Behavioral|Caregiver Problem-Solving Intervention|Subjects will meet for two counseling sessions while their family member is hospitalized and will receive the treatment manual, which contains the content for the 10 sessions, work sheets, and handouts. The standardized content will be complemented by tailoring to the specific concerns and problems of CGs which are influenced by culture and developmental life stage as well as the stroke and other environmental and personal factors. Problems specific to stroke caregiving are emphasized. After the stroke survivor has been discharged, the counselor will contact the CG weekly by phone for 5 weeks and then bi-weekly for the next three sessions (a total of 10 sessions) at times convenient for the CG.
16232670|NCT01141738|Behavioral|Wait List Control|Subjects in the WLC condition will receive usual patient and family education. If these subjects are noted to be distressed when assessment measures are administered or during conversation, the research assistant (RA) will inform the PI or Co-PI, who will follow-up. To aid retention, a counselor who is naïve to the CPSI will call the WLC subjects in the second and fifth months post-discharge to check contact information and ask how they are doing. Access to individual or group therapy through community resources during this study will be monitored during routine data collection. Following the T3 assessment, the WLC subjects will be offered a minimal intervention (receipt of the Adapting to Stress booklet 100 and five 30 minute telephone sessions).
16232671|NCT01141725|Drug|bendamustine hydrochloride|Given IV
16232672|NCT01141725|Drug|idarubicin|Given IV
16232673|NCT01141712|Procedure|Autologous transplant|Participants will receive the BEAM conditioning regimen followed by autologous HCT.
16232674|NCT01141712|Drug|BCNU|Participants will receive BCNU 300 mg/m^2 Day -6
16232675|NCT01141712|Drug|Etoposide|Participants will receive Etoposide 100 mg/m^2 BID Days -5 to -2
16232676|NCT01141712|Drug|Cytarabine|Participants will receive Cytarabine 100 mg/m^2 BID Days -5 to -2
16232677|NCT01141712|Drug|Melphalan|Participants will receive Melphalan 140 mg/m^2 Day -1
16232678|NCT01141660|Device|Endotracheal Tube|Patients randomized to either Laryngeal Mask Airway or Endotracheal tube prior to undergoing adenotonsillectomy.
16232680|NCT01141647|Behavioral|Vocational Rehabilitation|SCI-VIP: PrOMOTE evidence-based supported employment implemented for Veterans with spinal cord injury or other available vocational services
16232681|NCT01141634|Other|Homeopathic Remedies|Homeopathic remedies prepared according to the standards as set out by Health Canada
16232682|NCT01141608|Other|Vigorous Intensity High Dose Exercise|Participants randomized to the exercise condition will begin with supervised exercise sessions 3 times per week during the 12-week acute phase of the study. Supervised sessions will be conducted as one-on-one (i.e., individual) sessions. Vigorous intensity high dose exercise will be prescribed at a dose of 12 kcal/kg/week (KKW), with intensity ranging from 70-85% maximal heart rate.
16232683|NCT01141608|Other|Health Education Intervention|Participants randomized to the health education condition will also begin with visits 3 times per week during the 12-week acute phase. The health education sessions will be conducted as one-on-one (i.e., individual) sessions. Health education sessions will consist of information on health-related topics distributed via methods such as didactics, audio and video materials, and written materials.
16232684|NCT01141595|Drug|sapropterin dihydrochloride|Patients will be instructed to take 20 mg/kg/day of Kuvan® orally dissolved in 4 - 8oz. of water or apple juice with breakfast.
16232685|NCT01141569|Drug|Gamma-Secretase Inhibitor RO4929097|Given PO
16232686|NCT01141569|Other|Laboratory Biomarker Analysis|Correlative studies
16232687|NCT01141556|Drug|Selenase|After enrollment, patients will be prospectively randomized into two groups: a placebo group without selenium and a group receiving a loading dose of selenium 4000 μg intraoperatively,followed by a daily dosage of 1000 μg until leaving the ICU (longest supplementation 13 days).
16232688|NCT01141543|Drug|Plerixafor (mozobil)|"Cohort 1: Administration of PLERIXAFOR (240mcg/kg sc) before the first dose of FLUDARABINE and BUSULFAN Cohort 2: Administration of PLERIXAFOR (240mcg/kg sc) before the first and second dose of FLUDARABINE and BUSULFAN.
~Cohort 3: Administration of PLERIXAFOR (240mcg/kg sc) before the first, second, and third dose of FLUARABINE and BUSULFAN Cohort 4: Administration of PLERIXAFOR (240mcg/kg sc) before all four doses of FLUDARABINE and BUSULFAN"
16232689|NCT01141530|Other|No intervention|Because this study is a retrospective tissue bank study, there are no subjects actively participating in this study, thus no intervention. All samples studied will be obtained through the UAMS Tissue Bank.
16232690|NCT01141517|Behavioral|Not-On-Tobacco smoking cessation program|Adolescent quit-smoking program; Not-On-Tobacco
16232691|NCT01141504|Dietary Supplement|PeakATP 250|The nutritional intervention provides for oral ingestion of 250 mg PeakATP per day
16232692|NCT01141504|Dietary Supplement|Placebo|Placebo capsules that are comparable in size and color to the active comparator for blinding purposes
16232693|NCT01141504|Dietary Supplement|PeakATP 400|The nutritional intervention provides for oral ingestion of 400 mg PeakATP per day
16232694|NCT01141504|Dietary Supplement|PeakATP 400 plus proprietary blend|The nutritional intervention provides for oral ingestion of 400 mg PeakATP per day plus a proprietary blend of additional nutrients
16232695|NCT01141491|Biological|Trivalent ganglioside vaccine|Patients will be given 10 injections of ganglioside vaccine plus adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
16232696|NCT01141491|Biological|OPT-821|Patients will be given 10 injections of adjuvant OPT-821 as a 1.0 ml subcutaneous injection in an outpatient setting at Visit Weeks 1, 2, 3, 8, 16, 28, 40, 52, 68 and 84
16232697|NCT01141478|Radiation|Proton Beam Radiotherapy|Fifteen consecutive sessions
16232698|NCT01141478|Drug|Sorafenib|400 mg po bid
16232699|NCT01141465|Drug|Fluticasone / formoterol metered dose inhaler|Prescribed at the same BDP-equivalent dose as baseline ICS
16232700|NCT01141465|Drug|Fluticasone / salmeterol dry powder inhaler|Prescribed at the same BDP-equivalent dose as baseline ICS
16232701|NCT01141465|Drug|Budesonide / formoterol dry powder inhaler|Prescribed at the same BDP-equivalent dose as baseline ICS
16232702|NCT01141465|Drug|Fluticasone / salmeterol dry powder inhaler|Prescribed at ≥twice BDP-equivalent dose as baseline ICS
16232703|NCT01141465|Drug|Fluticasone / salmeterol metred dose inhaler|Prescribed at ≥twice BDP-equivalent dose as baseline ICS
16232704|NCT01141465|Drug|BUD/FOR dry powder inhaler|Prescribed at ≥twice BDP-equivalent dose as baseline ICS
16232705|NCT01141452|Drug|Extra-fine hydrofluoroalkane beclomethasone MDI|Step-up in baseline BDP-equivalent ICS dose
16232706|NCT01141452|Drug|Chlorofluorocarbon beclomethasone metered dose inhaler|Step-up in baseline BDP-equivalent ICS dose
16232707|NCT01141452|Drug|Fluticasone propionate metred dose inhaler|Step-up in baseline BDP-equivalent ICS dose
16232708|NCT01141452|Drug|Fluticasone propionate metred dose inhaler|Initiation of ICS therapy
16232709|NCT01141452|Drug|Hydrofluoroalkane beclomethasone metred dose inhaler|Initiation of ICS therapy
16232710|NCT01141452|Drug|Chlorofluorocarbon beclomethasone dipropionate|Initiation of ICS therapy
16232711|NCT01141439|Drug|Extra-fine hydrofluoroalkane-beclomethasone dipropionate|Initiation of HFA-BDP (any dose) in steroid naive patients via MDI
16232712|NCT01141439|Drug|Extra-fine hydrofluoroalkane-beclomethasone dipropionate|An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as HFA-BDP via MDI
16232713|NCT01141439|Drug|Fluticasone propionate|An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as FP via MDI
16232714|NCT01141439|Drug|Beclomethasone dipropionate|An increase in the baseline BDP-equivalent dose of inhaled corticosteroid as CFC-BDP via MDI
16232715|NCT01141439|Drug|fluticasone propionate|Initiation of FP (any dose) via MDI in steroid naive patient
16232716|NCT01141439|Drug|Chlorofluorocarbon beclomethasone dipropionate|Initiation of CFC-BDP (any dose) via MDI in steroid naive patient
16232717|NCT01141426|Behavioral|Intensive Short-term Dynamic Psychotherapy|The ISTDP model is an emotion focused brief format of psychotherapy that helps the patients identify and address emotional factors that culminate into exacerbation of depression and perpetuation of depression. The emphasis is on awareness of emotions and how they affect the person's behavioral patterns and mood. The research protocol calls for the treatment to be delivered according to a 20-session time-limited format. The first session is an extended 2-3 hour appointment (21), then sessions are planned to occur on a weekly basis lasting 60 minutes in duration. Termination in fewer sessions is based upon agreement between therapist and patient.
16233773|NCT01133054|Procedure|revascularization|surgery or stenting
16232718|NCT01141426|Behavioral|Secondary Care Treatment as Usual|At the four secondary health care sites, treatment as usual will consist of a multidisciplinary team approach including pharmacotherapy and clinical management, supportive or structured activities focused around symptom management and in some cases, individual or group psychotherapy. Pharmacotherapy treatment strategies will be individualized regimes informed by evidence-based recommendations. TAU will not be regulated in order to get a naturalistic assessment of standard secondary care treatment delivery with the exception that trial participants not be offered a psychodynamic / psychoanalytic based psychotherapy treatment during the course of the trial. Therapeutic interventions are likely to be heterogeneous therefore the trial coordinator will document in detail the dose and approaches delivered to each participant in order to account for this heterogeneity.
16232719|NCT01141374|Other|auriculotherapy by needles|The chinese auriculotherapy is a intervention used by Chinese Traditional Medicine in order to balance the body energy and to treat several kind of diseases using semi-permanent needles in specific points of the auricular pavilion.
16232720|NCT01141374|Other|auriculotherapy by seeds|We used the three points Shenmen, Kidney, and Brain Stem with mustard seeds, 1 time per week for 8 sessions.The subjects were instructed to stimulate the points three times a day.
16232721|NCT01141361|Procedure|GPS recording(s) of walking capacity in PAD patients|Home-based GPS recording(s) of walking capacity in PAD patients. Two evaluations will be performed. The second evaluation will be performed six months after the initial assessment (test 1) and only for patients with GPS maximal walking distance below 2000 meters at test 1. It is expected that some patients at test 2 will have undergo surgery or endovascular treatment.
16232722|NCT01141348|Behavioral|Special Intervention|16 week behavioral weight loss intervention included 2 hour weekly group sessions
16232723|NCT01141348|Behavioral|Delayed Intervention|During the randomized controlled trial, the Delayed Intervention (DI) group received two newsletters with study updates and general health information. Following the trial, the DI group received a 10-week weight loss program.
16232724|NCT01141335|Device|polypropylene mesh|A Lichtenstein tension-free hernioplasty is performed using a polypropylene mesh will be fixed by sutures in Polypropylene 2/0.
16232725|NCT01141335|Device|Infinit® PTFE mesh (WL Gore)|A Lichtenstein tension-free hernioplasty is performed using a PTFE mesh will be fixed by sutures in PTFE 2/0.
16232726|NCT01141322|Drug|Ursodeoxycholic Acid|ursodeoxycholic acid 13-15 mg/kg BW/day into 3 divided doses after meal till endpoint or the 8th week.
16232727|NCT01141322|Drug|Placebo|The placebo is of the same color, size and shape as UDCA, and assumed 100 mg per tab. Patients in this group will orally intake 13-15 mg/Kg BW/day of placebo into 3 divided doses after meal as UDCA treatment group, till the endpoint or the 8th week.
16232728|NCT01141309|Drug|sorafenib with everolimus|"Treatment will be with sorafenib 400 mg orally twice a day and everolimus 5 mg orally daily. Restage every 2 cycles *Cycle = 4 weeks of treatment.
~Subjects may consent to allowing blood to be drawn for DNA. Two blue top tubes will be required. Approximately 5-6 ml will be needed. This may be done at anytime, including before, during, or after treatment. This is not required to participate in the study."
16232729|NCT01141296|Drug|fenofibrate|fenofibrate 200 mg PO daily for 1 year
16232730|NCT01141296|Drug|placebo|Placebo pill identical to active drug will be given PO once a day for 1 year
16232731|NCT01141283|Drug|Buprenorphine transdermal patch|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
16232732|NCT01141283|Drug|Buprenorphine transdermal patch|Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
16232733|NCT01141283|Drug|Buprenorphine transdermal patch|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
16232734|NCT01141270|Drug|AFOLIA|single sc injection, 225 IU
16232735|NCT01141270|Drug|Gonal-f|single sc injection, 225IU
16232736|NCT01141257|Drug|Angiocal® (PRS-050-PEG40)|Single dose of Angiocal® i.v. (intravenous) on Day 1 and further applications of Angiocal® i.v. during a repeated dosing period.
16232737|NCT01141244|Drug|temsirolimus|Given IV
16232738|NCT01141244|Drug|temozolomide|Given orally
16232739|NCT01141244|Drug|irinotecan hydrochloride|Given IV
16232740|NCT01141244|Other|laboratory biomarker analysis|Correlative studies
16232741|NCT01141218|Other|internet-based protocol and physician referral|collection and review, dna and lab biomarker analysis, gene mapping
16232742|NCT01141205|Biological|AFO-18|18 peptides representing CD8 and CD4 epitopes mainly on HIV-1 in an adjuvants (CAF01)
16232743|NCT01141205|Drug|Saline|1.2 ml saline intramuscularly
16232744|NCT01141192|Dietary Supplement|vitamin D3, cholecalciferol|1 gelcap of 50,000 IU vitamin D3 plus 2 gelcaps of 5,000 IU vitamin D3 each; a total of 60,000 IU vitamin D3 dosed four weeks apart at weeks 0, 4, 8, and 12 of the 16 week study.
16232745|NCT01141192|Dietary Supplement|Inactive comparator|The inactive comparator dose provided was identical in appearance to the active comparator but contained no vitamin D3
16232746|NCT01141179|Drug|LEO 27847|2 mL (0.1 mg) dose of oral solution
16232747|NCT01141166|Behavioral|nutritional and a rehabilitation plan.|The intervention consisted of recommendations to the subject and their primary physician, and others providers, telephone calls of a nutritional and a rehabilitation plan.
16232748|NCT01141153|Drug|Acetylsalicylic Acid + clopidogrel + acenocoumarol|"Acetylsalicylic Acid 100 mg daily + Clopidogrel 75 mg daily + Acenocoumarol dosage with INR monitoring
~Treatment : 6 weeks for bare metal stent and 12 months for drug elution stent"
16232749|NCT01141153|Drug|Acetylsalicylic Acid + clopidogrel|"Salicylic Acid, 300 mg daily + Clopidogrel 75 mg daily
~Treatment : 6 weeks for bare metal stent and 12 months for drug elution stent."
16232750|NCT01141140|Behavioral|Healthy|Favourable nutritional characteristics.
16232751|NCT01141140|Behavioral|Diet|Benefits of an ingredient/nutrient for weight management
16232752|NCT01141140|Behavioral|Unhealthy|Hedonic characteristics and less healthy ingredients.
16232753|NCT01141127|Drug|Tranexamic Acid|Comparison of two dosage regimen of Tranexamic Acid
16232754|NCT01141114|Other|Patient navigation|Letter and Colorectal Cancer Screening Brochure mailed to patients. Telephone outreach by Patient Navigators.
16232755|NCT01141114|Other|Usual care|Usual care
16232862|NCT01140165|Other|cheese|the effect of cheese intake versus butter intake on blood lipids (primarily)
16233054|NCT01138605|Drug|Darunavir|450 mg composed via oral solution or various tablets, twice daily in combination with ritonavir for body weight between 30 and 40 kg
16232756|NCT01141088|Procedure|Bilateral stent-in-stent insertion|Following negotiation of both IHD by two guidewires, inserted 1st stent to left IHD side. After deployment of the 1st stent across the hilar stricture, the remaining guide wire across the 1st stent was carefully withdrawn using an ERCP catheter without pulling it back completely. Then that guidewie was inserted under fluoroscopic guidance into the undrained right IHD through the central portion of the 1st stent. The 2nd cross-wired stent was then introduced over a guidewire through the central open mesh and then was deployed into the right IHD, so that the central portion of the 2nd stent overlapped the central portion of the 1st stent, forming a Y-shape.
16232757|NCT01141088|Procedure|Bilateral side-by-side insertion|Following the introduction of two guidewires, the first stent was pushed and deployed into the left hepatic duct as possible, and then subsequently the second stent was pushed and deployed into the right hepatic duct, using the same method. In tight stricture during a guidewire manipulation, pneumatic biliary balloon dilation prior to insertion of first stent was performed. All stents were positioned above the level of the papilla, with their distal ends at the same level as possible. The diameter of the stent used in each case (8 or 10 mm) depended on the maximum diameter of the common bile duct (CBD).
16232758|NCT01141075|Drug|Ataluren|Ataluren will be provided as a vanilla-flavored powder to be mixed with water.
16232759|NCT01141062|Device|Philips MR-guided HIFU|HIFU is the use of focused ultrasound energy to penetrate through soft tissue and causes localized high temperatures (55°C to 70°C) for a few seconds within the target producing well defined regions of protein denaturation, irreversible cell damage, and coagulative necrosis.
16232760|NCT01141049|Drug|Gabapentin|During week 1 the dosage will be increased 3 times. Days 1 and 2, participants will receive 400 mg of Gabapentin three times daily. During days 3 and 4 the dosage will be increased to 800 mg three times daily. On day 5 through 7, participants will receive a dose of 1200 mg three times daily, which will continue from week 2 through 8. During week 9 patients will be tapered off for the duration of the week.
16232761|NCT01141049|Other|Placebo|Placebo, TID
16232762|NCT01141036|Drug|propofol|Propofol will be initiated with a 30-50 mg i.v. bolus followed by repeated 10-20 mg doses at variable intervals (approximately 15 s, at the discretion of the endoscopist/nurse) until an appropriate level of sedation will be achieved.
16232763|NCT01141036|Drug|Midazolam|Midazolam (0.5-1.0 mg) will be administered in a similar fashion with incremental dosing at intervals of approximately 1-3 min until a level of sedation will be achieved
16232764|NCT01141023|Drug|DaTscan|
16232765|NCT01141010|Other|Language|Plain language without psychological intervention
16232766|NCT01141010|Other|Language|Psychological linguistic intervention will be given
16232767|NCT01140997|Drug|Ypeginterferon alfa-2b|sc, qw, for 48 weeks.
16232768|NCT01140997|Drug|Peginterferon alfa-2a|sc, qw, for 48 weeks.
16232769|NCT01140984|Drug|Methylprednisolone (Intra-arterial continuous infusion of corticosteroids)|Sedation/anesthesia of patient followed by placement of a 4F vascular sheath and a diagnostic and hepatic angiogram. Angiographic catheter tip to be placed in the proximal proper hepatic artery, secured in place externally and connected to an arterial line pressurized system which allows continuous drip infusion of methylprednisolone diluted in normal saline (600mg/m2 with maximal total dose of 100mg diluted in 480cc in normal saline administered at 20cc/hr for 24 hours).
16232770|NCT01140971|Drug|Misoprostol|Vaginal application of 25 micrograms every 6 hours until cervical ripening reach Bishop 6 or more
16232771|NCT01140971|Device|Foley|After Foley introduction, every 6 hours vaginal exam was performed. The cases on Bishop score increase or occurred spontaneous exit of catheter or spontaneous labour had been initiated are considered success.The failure was adopted if after48 hours occurred no cervical modifications.
16232772|NCT01140932|Drug|Prednisolone|12 days of corticosteroids treatment (prednisolone 37,5 mg/day)
16232773|NCT01140932|Behavioral|Lifestyle change|High calorie diet (130 % of recommended daily energy intake) and relative physical inactivity (no exercise and at least 8 hours of rest/day)
16232774|NCT01140906|Drug|Placebo|capsules, daily, orally
16232775|NCT01140906|Drug|Vortioxetine (Lu AA21004)|encapsulated tablets, daily, orally
16232776|NCT01140906|Drug|Duloxetine|encapsulated capsules, daily, orally
16232777|NCT01140893|Drug|Exenatide|"Research drug (exenatide or placebo), will begin at V0, after randomization. The initial dosage for the first month will be 5 µg SC BID. Injections can be administered at any time within the 60 minute period before the morning and evening meal.
~From V1, research drug will be titrated from 5 to 10 µg SC BID. If gastro-intestinal adverse effects occur with 10 µg SC BID, the dosage will be back-titrated to 5 µg SC BID. Thus, the higher research drug dosage tolerated will be used during the study time."
16232778|NCT01140893|Drug|Placebo|Placebo
16232779|NCT01140880|Drug|Truvada|Truvada At qualifying exposure, participants will take 28 days' worth (at one pill per day) of 200 mg emtricitabine and 300 mg tenofovir DF (Truvada).
16232780|NCT01140867|Drug|zonisamide|zonisamide 100 mg tablet
16232781|NCT01140854|Procedure|Lumbar spine surgery|(non-experimental) we do not intend to change the criteria of selection for simple lumbar spine surgery, anesthesia, or the postoperative management of the patients studied.
16232782|NCT01140854|Other|Neurologic/neuropsychometric examinations|To measure postoperative cognitive dysfunction.
16232783|NCT01140841|Drug|Fipamezole ODT|Subjects take three daily doses of Fipamezole ODT, with each dose escalating from 30 to 60, 90, 120, 150 and up to 180 mg over 8 weeks.
16232784|NCT01140841|Drug|Placebo|1 to 2 tablets three times per day to be taken according to the same schedule as the active study drug.
16232785|NCT01140828|Drug|Rabeprazole|Rabeprazole 20mg once daily
16232786|NCT01140828|Drug|Rabeprazole Placebo|one tab once daily
16232787|NCT01140815|Device|Total Knee Replacement|Smith and Nephew Total Knee Replacement
16232788|NCT01140815|Device|Deuce|Smith and Nephew Bicompartmental Knee Replacement
16232789|NCT01140763|Device|Sysmex's 5-blade lymph node cutter|"A maximum of 3 dissected sentinel lymph nodes (SLN) per subject will be included in this study. Lymph nodes will be sliced at 1 mm intervals with Sysmex's 5-blade lymph node cutter. Alternate slices will be allocated to either reference histopathology or test histopathology. Three serial sections will be cut every 200 µm (level): the 1st section per level for hematoxylin & eosin (H&E), the middle section of the 3rd level for Immunohistochemistry (IHC)(pan- cytokeratin antibody clone AE1/AE3). All other sections will be blanks in case further analysis is needed."
16232790|NCT01140737|Drug|Axitinib|Patients will take axitinib tablets 5 mg by mouth twice daily continuously. There may be one dose reduction to 3mg twice daily. A four week dosing period will be considered as 1 cycle of treatment. Axitinib treatment will be continued until disease progression, or the development of limiting toxicity.
16232791|NCT01140711|Procedure|fMRI imaging following visual stimulation of food and non-food images|"fMRI Scans will be performed in a 3 tesla MRI scanner. All subjects will be scanned for anatomical imaging without injection of contrast material. These structural images will be used to localize the functional data obtained. Functional test will include several measurements of brain activity while viewing visual stimuli.
~fMRI allows collection of information about brain activity with good spatial and temporal resolution. Protocols allow rapid assessment of regional activation in different brain regions during exposure to different visual stimuli.It provides a detailed functional map.
~Scan test protocol includes anatomical measurement - 3D FSPGE T1w sequence, Asset DTI and repeated fMRI measurements (based on echo EPI, T2 * w, BOLD sequences). Test paradigms include picture collections of various foods non-food objects similar in size, color and shape."
16232792|NCT01140698|Other|Blood sample on Guthrie paper from cord blood, and day 3 of life and before discharge|Mass spectroscopy on the blood sample that are taken as routine for the national inborn errors survey
16232793|NCT01140672|Drug|PF-04634817|Oral solution of PF-04634817 at 3 mg will be given once daily for 14 days.
16232794|NCT01140672|Drug|PF-04634817|Oral solution of PF-04634817 at 3 mg will be given once daily for 14 days.
16232795|NCT01140672|Drug|PF-04634817|Oral solution of PF-04634817 at 30 mg will be given once daily for 14 days.
16232796|NCT01140672|Drug|PF-04634817|Oral solution of PF-04634817 at 100 mg will be given once daily for 14 days.
16232797|NCT01140672|Drug|PF-04634817|Oral solution of PF-04634817 at 300 mg will be given once daily for 14 days.
16232798|NCT01140672|Drug|PF-04634817|Cohort will only be dosed if necessary. Dose selected for this cohort may be a repeat of a previous cohort or intermediate dose not to exceed 300 mg.
16232799|NCT01140659|Procedure|Video-assisted sympathectomy|All participants were randomized into two groups of 20 patients (G3 and G4) and underwent video-assisted sympathectomy, being followed for 12 months. During this period, the subjects completed a questionnaire about quality of life and carried out the measurements of sweat by VapoMeter.
16232800|NCT01140646|Drug|S-adenosyl-L-methionine disulfate p-toluene-sulfonate|Given orally
16232801|NCT01140646|Other|questionnaire administration|Ancillary studies
16232802|NCT01140646|Procedure|quality-of-life assessment|Ancillary studies
16232803|NCT01140620|Drug|ketamine|ketamine infusion to achieve plasma concentrations of 100 ng/mL. Duration approximately 3 hours
16232804|NCT01140620|Drug|risperidone|risperidone (2 mg) capsule. One dosing of 2 mg.
16232805|NCT01140620|Drug|saline|saline infusion. Duration approximately 3 hours
16232806|NCT01140620|Drug|placebo risperidone|placebo capsule to match risperidone 2 mg capsule
16232807|NCT01140607|Drug|Cabazitaxel (XRP6258)|"Pharmaceutical form:solution for infusion
~Route of administration: intravenous"
16232808|NCT01140594|Procedure|Photorefractive keratectomy|One eye undergoes wavefront-guided PRK with the Visx S4 CustomVue excimer laser.
16232809|NCT01140594|Procedure|Laser in-situ keratomileusis|One eye undergoes wavefront-guided LASIK using the Visx S4 excimer laser.
16232810|NCT01140581|Drug|DRONEDARONE|Pharmaceutical form: tablet Route of administration: oral Dose regimen: 400 mg
16232811|NCT01140568|Drug|nilotinib|400mg po (orally) BID (twice daily)
16232812|NCT01140555|Device|GYNECARE GYNOCCLUDE™|GYNECARE GYNOCCLUDE™ Doppler Guided Uterine Artery Occlusion Device
16232813|NCT01140542|Drug|Roflumilast|500µg, once daily
16232814|NCT01140529|Drug|Dexmedetomidine|Bolus and continuous infusion
16232815|NCT01140529|Drug|Haloperidol|Bolus doses
16232816|NCT01140529|Drug|Saline|Bolus and continuous infusion
16232817|NCT01140516|Drug|Trimethoprim|2mg/kg,orally until febrile UTI occurs or until completion of the study if the patients do not develop any UTI.
16232818|NCT01140516|Other|Simple Syrup|2mg/kg,orally until febrile UTI occurs or until completion of the study if the patients do not develop any UTI.
16232819|NCT01140503|Drug|Apremilast|Apremilast 20mg PO BID
16232820|NCT01140490|Procedure|Sub-total Parathyroidectomy|Sub-total Parathyroidectomy
16232821|NCT01140477|Device|Toric Accommodating Lens|Toric accommodating lens implanted after cataract extraction
16232822|NCT01140477|Device|Accommodating Lens|Accommodating lens implanted after cataract extraction
16232823|NCT01140464|Other|Collaborative care|Provision of depression care management in the primary care setting to improve delivery of evidence based treatments
16232824|NCT01140464|Other|Enhanced Usual Care|Provision of screening results to provider, teen and parent with recommendation to seek further care
16232825|NCT01140451|Drug|Ataluren|Ataluren will be provided as a vanilla-flavored powder to be mixed with water or milk.
16232826|NCT01140438|Drug|metformin+ NPH insulin|Metformin 500 mg + 500 mg + 1000 mg NPH insulin , initially 0.20 U/kg body weight.
16232827|NCT01140438|Drug|metformin + sitagliptin +/- repaglinide|Metformin 500 mg + 500 mg + 1000 mg Sitagliptin 100 mg x 1 Repaglinide 1 mg x 3
16232828|NCT01140425|Drug|PF-00232798|600 mg oral solution once daily x 7 days
16232829|NCT01140425|Drug|PF-00232798|300 mg oral solution once daily x 7 days
16232830|NCT01140425|Drug|Placebo|Oral solution once daily x 7 days
16232831|NCT01140425|Drug|Moxifloxacin|400 mg tablet single dose
16232832|NCT01140412|Drug|Maraviroc|maraviroc 300 mg BID x 5 days
16232833|NCT01140412|Drug|Fosamprenavir/ritonavir|fosamprenavir/ritonavir 700/100 mg BID x 10 days
16232834|NCT01140412|Drug|Maraviroc + Fosamprenavir/ritonavir|maraviroc 300 mg BID + fosamprenavir/ritonavir 700/100 mg BID x 10 days
16232835|NCT01140412|Drug|Maraviroc|maraviroc 300 mg QD x 5 days
16232836|NCT01140412|Drug|Fosamprenavir/ritonavir|fosamprenavir/ritonavir 1400/100 mg QD x 10 days
16232837|NCT01140412|Drug|Maraviroc + Fosamprenavir/ritonavir|maraviroc 300 mg QD + fosamprenavir/ritonavir 1400/100 mg QD x 10 days
16232838|NCT01140399|Drug|Furosemide or Furosemide and Dopamine|"Patients randomized to pharmacological treatment receive
~either intravenous diuretics at escalating doses up to 20 mg/h
~or intravenous diuretics up to 20 mg/h and dopamine infusion at a constant rate of 3 mcg/Kg/m."
16232839|NCT01140399|Device|Ultrafiltration|"All loop diuretics will be discontinued. Rate of fluid removal will be based on the extent of fluid overload as assessed by increase in body weight vs the patient's known dry weight
~less than 3 kg 200 ml/h
~more than 3 kg and less than 5 kg 300 mlh
~more than 5 kg 500 mlh
~Criteria for achievement of target UF goals are removal of > 50% and <70% of fluid excess based on the estimated increase in body weight Diuretic infusion is allowed provided that a minimum of 3 hours after the end of the UF session have elapsed, at a maximum cumulative dose of 100 mg furosemide, till start of the next UF session The use of inotropic agents is prohibited"
16232840|NCT01140373|Biological|engineered autologous T cells|Three cohorts of patients each will receive escalating doses of transduced autologous chimeric T lymphocytes at 1 x 10^7 CAR+ T cells/kg, 3 x 10^7 CAR+ T cells/kg, and 1 x 108 CAR+ T cells/kg, respectively. One patient will be initially added to the three already enrolled in cohort 1 using a new variant vector expressing the P28z CAR, and up to three patients may be added to each cohort, for a total of up to six each, in the case of Grade 3 toxicity and/or sub-optimal imaging. A 4th cohort of three patients may be added if an anti-PSMA effect is observed either immunologically or radiographically or if there is preferential targeting of the cells at a particular dose level. The dose level of the 4th cohort would be from a previously tested dose level. All patients will receive one dose of cyclophosphamide (Cy) at 300mg/m2 iv one day prior to infusion of T cells.
16232841|NCT01140373|Drug|cyclophosphamide|Three cohorts of patients each will receive escalating doses of transduced autologous chimeric T lymphocytes at 1 x 10^7 CAR+ T cells/kg, 3 x 10^7 CAR+ T cells/kg, and 1 x 10^8 CAR+ T cells/kg, respectively. One patient will be initially added to the three already enrolled in cohort 1 using a new variant vector expressing the P28z CAR, and up to three patients may be added to each cohort, for a total of up to six each, in the case of Grade 3 toxicity and/or sub-optimal imaging. A 4th cohort of three patients may be added if an anti-PSMA effect is observed either immunologically or radiographically or if there is preferential targeting of the cells at a particular dose level. The dose level of the 4th cohort would be from a previously tested dose level. All patients will receive one dose of cyclophosphamide (Cy) at 300mg/m2 iv one day prior to infusion of T cells.
16232842|NCT01140360|Drug|Gleevec|Gleevec will be dosed orally with a starting dose of 100 mg twice daily for patients with a BSA > 1.8 m2 or 55 mg/m2 twice daily for patients with BSA < 1.8 m2. For patients with a BSA > 1.8 m2 the dose will increase by increments of 100 mg bid every two weeks as tolerated up to a maximum dose of 400 mg bid. For patients with a BSA < 1.8 m2 the dose will increase by increments of 55 mg/m2 bid every two weeks as tolerated up to a maximum dose of 220 mg/m2 bid.Treatment will continue for 6 months with an option to continue for 24 months if the patient is deriving a clinical benefit.
16232843|NCT01140347|Biological|Placebo|8 mg/kg IV every 2 weeks
16232844|NCT01140347|Biological|Ramucirumab DP (IMC-1121B)|8 milligrams/kilogram (mg/kg) intravenous (IV) every 2 weeks
16232845|NCT01140347|Other|BSC|Palliative and supportive care for disease-related symptoms and toxicity associated with treatment as deemed medically necessary and appropriate in the opinion of the investigator.
16232846|NCT01140334|Behavioral|Voucher Reinforcement|Patients in this condition will be able to earn a voucher for each week that they have attended all scheduled psychiatric sessions. These sessions may include individual therapy appointments, group therapy appointments, or psychiatrist appointments. Each voucher will be worth $25, and can be exchanged for goods and services that will be purchased by a research assistant. The maximum amount of voucher earnings over the study is $300.
16232847|NCT01140334|Behavioral|Standard Control|Patients assigned to this condition will be treated at ATS for psychological problems. They will be scheduled to participate in individual therapy sessions with a psychiatrist and with their substance abuse counselor. They will also be referred to attend group therapy one time per week. No voucher incentive will be offered in this condition.
16232848|NCT01140321|Drug|Neridronate|"Neridronate is an aminobisphosfonate of third generation that has been proved in several clinical trials to have the ability to inhibit osteoclast-mediated bone resorption and it is generally well tollerated also at high doses. Thanks to these properties it has been used in the treatment of several bone disorders such as Paget's disease and Osteogenesis Imperfecta. Neridronate, given intravenously or orally (tablets), reduces both the levels of bone alcaline phosphatase and of the other markers of bone resorption activity. Recently it has been approved by the Italian Ministry of Health for the commercialization with the indication Osteogenesis Imperfecta."
16232849|NCT01140308|Drug|CoEnzyme Q10|Randomization to Treatment: Simvastatin 20mg + 600 mg CoQ10 (pill) Load Subjects for 2 weeks on Treatment (CoQ10) Eight weeks of Treatment
16232850|NCT01140308|Drug|Placebo|Randomization to Treatment: Simvastatin 20mg + Placebo 600mg Load Subjects for 2 weeks on Treatment Eight weeks of treatment
16232851|NCT01140295|Drug|polyethylene glycol, senna|"Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age >12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.
~Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days."
16232852|NCT01140282|Other|questionnaire administration|Administered within 3 days of baseline testing and at post-trial visit
16232853|NCT01140282|Procedure|quality-of-life assessment|Administered within 3 days of baseline testing and at post-trial visit
16232854|NCT01140282|Procedure|management of therapy complications|Assessed within 3 days of baseline testing and at post-trial visit
16232855|NCT01140282|Behavioral|exercise intervention|12 week exercise intervention
16232856|NCT01140269|Other|PCR test|PCR samples will test for Staphylococcus aureus (including MRSA) from wound swab and positive blood culture samples to augment treatment decisions. Serial PCR testing will follow after positive results to catalog pathogen loads over the course of treatment in a blinded fashion.
16232857|NCT01140243|Dietary Supplement|LCPUFA|premature infant formula supplemented with LCPUFA
16232858|NCT01140217|Drug|Norethindrone Acetate|Norethindrone Acetate Transdermal Delivery System
16232859|NCT01140204|Device|Implantation of a bare metal stent|Bare Metal Stent
16232860|NCT01140191|Drug|WR 279,396|Topical application of WR 279,396 cream (15% paromomycin + 0.5% gentamicin)once daily for 20 days
16232861|NCT01140178|Drug|HPPH|Given IV
16232925|NCT01139723|Drug|bevacizumab|Intravenous repeating dose
16232863|NCT01140139|Biological|HIV DNA Vaccine|0.4 mg of DNA plasmids encoding HIV env A, B, C and Rev B, gag A, B and RT mut formulated in PEI and glucose was applied topically with the DermaPrep procedure six times during cycles of 7 weeks of active HAART. Every immunization cycle was followed by four weeks of therapy interruption.
16232864|NCT01140126|Drug|Antibody UB-421|Single intravenous infusion at day 0 of a liquid dose of 1, 5, 10 or 25 mg/kg body weight.
16232865|NCT01140113|Procedure|Modified Ultrafiltration|After weaning from bypass patients had undergone to modified ultrafiltration for 15 minutes with a filtration flow at 300 ml/min
16232866|NCT01140100|Drug|propofol|
16232867|NCT01140100|Drug|thiopental,propofol|
16232868|NCT01140087|Procedure|Face Transplant|Transplantation of donor facial skin, tissue, muscle, and bone as needed
16232869|NCT01140074|Drug|Zinc Sulfate|Zinc Sulfate in sugar sirup will be given orally in dosis of 10-20 mg per day for 10 days
16232870|NCT01140061|Drug|MK-0873 Patch|MK-0873 skin patches containing 0.05%. 0.5%, or 2% MK-0873
16232871|NCT01140061|Drug|MK-0873 Cream|MK-0873 cream containing 0.05%, 0.5%, or 2% MK-0873
16232872|NCT01140061|Drug|Placebo Patch|Placebo patches matching MK-0873 0.05%, 0.5%, or 2% patches
16232873|NCT01140061|Drug|Placebo Cream|Placebo cream matching MK-0873 0.05%, 0.5%, or 2%
16232874|NCT01140061|Drug|Plain patch|Plain patch containing no MK-0873 or placebo
16232875|NCT01140035|Other|Administration of continuous insulin infusion for glycemic control in brain dead donors|As per protocol
16232876|NCT01140022|Other|CT Screening|Patients will use a kiosk module that will provide information about CT screening and assess their risk for CT. Patients choosing to get a CT screening will receive a printout instructing the provider or nurse to collect a urine sample for CT screening.
16232877|NCT01140009|Biological|Fluviral 2010/11 Tri-valent Seasonal Influenza vaccine|Vaccination of .05mL of Fluviral vaccine will be injected once at either visit 1 or 2 depending upon randomization in the deltoid muscle of the non-dominant arm
16232878|NCT01140009|Biological|Fluviral 2010/11 Tri-valent Seasonal Influenza vaccine|Vaccination of .05mL of Fluviral vaccine will be injected once at either visit 1 or 2 depending upon randomization in the deltoid muscle of the non-dominant arm
16232879|NCT01139996|Drug|Clonidine|An oral loading dose of Clonidine 0.3 mg and placement of Clonidine Transdermal system at a dose of 0.3-mg/day (Catapres TTS-3), with patch overlay, followed by a final dose of Clonidine 0.3mg after 12 hours
16232880|NCT01139996|Drug|Placebo|A placebo oral tablet and the overlay patch only and in 12 hours they will receive a second and final tablet
16232881|NCT01139983|Genetic|DNA analysis|
16232882|NCT01139983|Genetic|RNA analysis|
16232883|NCT01139983|Genetic|fluorescence in situ hybridization|
16232884|NCT01139983|Genetic|microarray analysis|
16232885|NCT01139983|Genetic|polymerase chain reaction|
16232886|NCT01139983|Genetic|reverse transcriptase-polymerase chain reaction|
16232887|NCT01139983|Other|laboratory biomarker analysis|
16232888|NCT01139970|Other|Laboratory Biomarker Analysis|Correlative studies
16232889|NCT01139970|Other|Pharmacological Study|Correlative studies
16232890|NCT01139970|Drug|Temozolomide|Given PO
16232891|NCT01139970|Drug|Veliparib|Given PO
16232892|NCT01139957|Procedure|Evaluation of Cancer Risk Factors|Ancillary studies
16232893|NCT01139957|Other|Quality-of-Life Assessment|Ancillary studies
16232894|NCT01139957|Other|Questionnaire Administration|Ancillary studies
16232895|NCT01139957|Procedure|Study of High Risk Factors|Ancillary studies
16232896|NCT01139944|Genetic|DNA methylation analysis|
16232897|NCT01139944|Genetic|polymerase chain reaction|
16232898|NCT01139944|Other|laboratory biomarker analysis|
16232899|NCT01139931|Genetic|DNA methylation analysis|
16232900|NCT01139931|Genetic|gene expression analysis|
16232901|NCT01139931|Genetic|microarray analysis|
16232902|NCT01139931|Genetic|polymorphism analysis|
16232903|NCT01139931|Other|laboratory biomarker analysis|
16232904|NCT01139905|Other|lopinavir/ritonavir|standard dose of lopinavir/ritonavir 100/25 mg tablet q 12 hour.
16232905|NCT01139892|Procedure|Surgical management|
16232906|NCT01139892|Procedure|Endovascular management|
16232907|NCT01139879|Device|P400 mattress|The P400 mattress will be placed for a period of 12 weeks.
16232908|NCT01139853|Device|Nasogastric Tube|Insertion of a 10 French Nasogastric tube prior to surgery
16232909|NCT01139840|Dietary Supplement|vitamin D2|Study Supplement
16232910|NCT01139840|Dietary Supplement|vitamin D3|Study Supplement
16232911|NCT01139814|Device|Amigo catheter robot|The Amigo Catheter System is intended to facilitate manipulation, positioning and control of a Diagnostic Catheter.
16232912|NCT01139801|Drug|Oxytocin|Foley balloon placement with intravenous low dose oxytocin administration starting 2 milliunits per minute.
16232913|NCT01139801|Drug|Misoprostol|Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement
16232914|NCT01139788|Drug|LY2624587|"6-900 mg, administered intravenously, weekly for a minimum of one (1) 28 day cycle.
~If patients are determined to be receiving benefit, study treatment may be continued for up to one (1) year (12 cycles of 28 days)."
16232915|NCT01139775|Drug|Pemetrexed|Administered intravenously as a continuous 10-minute infusion
16232916|NCT01139775|Drug|Cisplatin|Administered intravenously as a continuous 1-hour infusion
16232917|NCT01139775|Drug|LY2603618|Administered intravenously as a continuous 1-hour infusion
16232918|NCT01139762|Drug|Tadalafil|5 milligrams (mg) administered orally, once daily for 26 weeks
16232919|NCT01139762|Drug|Placebo|Administered orally, once daily for 26 weeks
16232920|NCT01139762|Drug|Finasteride|5mg administered orally, once daily for 26 weeks
16232921|NCT01139749|Drug|oral isotretinoin|capsules of 20 mg a day, every other day, for six months
16232922|NCT01139749|Drug|salicylic acid and ciclopirox olamine|Topical salicylic acid and ciclopirox olamine shampoo for scalp and face cleansing, every other day, for six months
16232923|NCT01139736|Dietary Supplement|VSL#3|IBS Patients will receive VSL#3 (450 billion lyophilized bacteria/sachet) twice daily for 4 weeks
16232924|NCT01139723|Drug|MINT1526A|Intravenous escalating dose
16232928|NCT01139671|Drug|Remifentanil|"Wisdom teeth removal under general anaesthesia is usually suitable for ambulatory surgery.
~The choice of opioid in dental day surgery is based on the need for a rapid and full recovery, as well as less morphine administration. Whether remifentanil can achieve these goals remains to be proved, especially regarding remifentanil-induced hyperalgesia, the potential prolonged Post Anesthesia Care Unit (PACU) stay, or remifentanil-induced workload for nurses."
16232929|NCT01139645|Drug|Rabeprazole or Esomeprazole or Lanzoprazole|1/3 of the patients are taking Pariet (Rabeprazole) 20 mg once daily 1/3 of the patients are taking Nexium (Esomeprazole) 40 mg once daily 1/3 of the patients are taking Lanzor (Lanzoprazole) 30 mg once daily
16232930|NCT01139606|Other|Vibration resistance training|adding vibration to a standard resistance training with free-weights and checking the effect on muscle strength development and everyday functioning of upper limbs in untrained adults.
16232931|NCT01139580|Drug|Calcipotriene Foam|Calcipotriene Foam 0.005%. All treatments will be administered to the skin twice daily (am-pm) for 8 weeks for subjects in this group
16232932|NCT01139580|Drug|Vehicle Foam|Vehicle Foam. All treatments will be administered to the skin twice daily (am-pm) for 8 weeks for subjects in this group
16232933|NCT01139541|Behavioral|Social walking intervention|In this intervention, we are interested in the impact of group dynamics on the propensity to use the Walkstations. The intervention consists of 4 levels: control, individual, pair, and group.
16232934|NCT01139528|Procedure|Bouquet pinning of the 5th metacarpal bone|The fracture is reduced under general anesthesia and 2-3 K-pins are introduced in the medullar cavity to keep the fracture in the reduced position
16232935|NCT01139515|Drug|Eletriptan commercial tablet|20 mg tablet, single dose
16232936|NCT01139515|Drug|Eletriptan commercial tablet|40 mg tablet, single dose of 1 X 40 mg
16232937|NCT01139515|Drug|Eletriptan commercial tablet|40 mg tablet, single dose of 2 X 40 mg
16232938|NCT01139515|Drug|Eletriptan commercial tablet|40 mg tablet, 1 X 40 mg given two times: the second 2 hours after the first
16232939|NCT01139502|Behavioral|Work rehabilitation based on the cognitive therapeutical model|Work rehabilitation including two weekly meetings in which participant and work consultant discuss problems interfering with work and social interaction. Home work related to these problems is assigned between the meetings.
16232940|NCT01139502|Behavioral|Work rehabilitation with the addition of cognitive training|Work rehabilitation with the addition of two hours weekly training of concentration, memory, and executive function
16232941|NCT01139489|Other|procalcitonin-guidance|If procalcitonin levels decrease to predefined levels, antibiotic therapy will be discontinued.
16232942|NCT01139463|Drug|Haloperidol or olanzapine|Haloperidol tablet - 5 mg twice daily (morning and evening) by mouth Olanzapine tablet - 5 mg twice daily (morning and evening) by mouth
16232943|NCT01139450|Drug|0417|Topical 0417 test product applied twice daily for 4 weeks
16232944|NCT01139450|Drug|Vehicle of 0417 test product|Vehicle of 0417 test product applied twice daily for 4 weeks
16232945|NCT01139450|Drug|Tacrolimus Ointment 0.03%|Reference product for 0417 test product. Apply twice daily for 4 weeks
16232946|NCT01139437|Biological|Standard Dose HPIV2 Vaccine|10^6 tissue culture infectious dose 50% (TCID50) administered intranasally in a single dose
16232947|NCT01139437|Biological|Low dose HPIV2 vaccine|10^5 TCID50 administered in a single dose
16232948|NCT01139437|Other|Placebo|Matched placebo
16232949|NCT01139424|Device|endoscopic suturing|endoscopic suturing of the anastomotic leak
16232950|NCT01139411|Behavioral|Behavioral Weight Control with Enhanced Parent Involvement|
16232951|NCT01139411|Behavioral|Behavioral Weight Control with Minimal Parent Involvement|
16232952|NCT01139398|Dietary Supplement|Limicol (plant extract)|Artichoke extract, anti-caking agents: dicalcium phosphate, calcium citrate, vegetable magnesium stearate, red yeast rice, microcrystalline cellulose, natural vitamin E, garlic extract, sugar cane policosanols, inositol hexanicotinate, vitamin B3, vitamin B2.
16232953|NCT01139385|Procedure|Harmonic scalpel|The Cholecystectomy is performed using only Harmonic Scalpel to mobilize the Cholecystis and to close the cystic duct and the cystic artery
16232954|NCT01139385|Procedure|Traditional|The cholecystectomy is performed using Harmonic Scalpel to mobilize the cholecystis and the cystic duct and the cystic artery are closed by titanium clips
16232955|NCT01139372|Other|FID 115958D (Lubricant Eye Drop)|1 drop in each eye at least twice daily
16232956|NCT01139359|Drug|darinaparsin|I.V. darinaparsin given in a dose escalation manner, once a day for 5 days per cycle.
16232957|NCT01139359|Drug|CHOP|Cyclophosphamide 750 mg/m2 IV Day 8 of each Cycle; Doxorubicin 50 mg/m2 IV Day 8 of each Cycle; Vincristine 1.4 mg/m2 IV Day 8 of each Cycle; Prednisone 100 mg oral Days 8-12 of each Cycle.
16232958|NCT01139346|Drug|darinaparsin|dose escalating, starting at 200 mg twice per day for 21 days continuous followed by a 7 day rest per cycle.
16232959|NCT01139333|Genetic|gene expression analysis|
16232960|NCT01139333|Genetic|western blotting|
16232961|NCT01139333|Other|flow cytometry|
16232962|NCT01139333|Other|laboratory biomarker analysis|
16232963|NCT01139320|Genetic|DNA analysis|
16232964|NCT01139320|Genetic|polymerase chain reaction|
16232965|NCT01139320|Other|laboratory biomarker analysis|
16232966|NCT01139320|Other|pharmacological study|
16232967|NCT01139307|Other|cell culture procedure|
16232968|NCT01139307|Other|laboratory biomarker analysis|
16232969|NCT01139294|Drug|Hylenex|1ml subcutaneous with initiation of intravenous fluids then every 24 hrs with a maximum dose of 3 injections in 72 hours
16232970|NCT01139281|Drug|Ginkgo Biloba Extract (GBE761)|The subjects were randomized and allocated in two groups: Control Group(CG) and Study Group(SG). the study group received GBE761(120mg twice a day) plus cisplatin and was guided to ingest GBE761 just before initial cisplatin dosage. The maximum cumulative cisplatin dosage was 300mg/m². They were followed up for ninety days. Comparisons were made between baseline distortion-product otoacoustic emissions measurements and those DPOAE records after maximum cumulative cisplatin dosage.
16233055|NCT01138605|Drug|Darunavir|400 mg tablet, intake of 2 tablets once daily in combination with ritonavir
16233056|NCT01138605|Drug|Ritonavir|100 mg tablet, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
16233883|NCT01132313|Drug|Ribavirin|40 weeks, according to label
16232971|NCT01139281|Drug|Placebo|The subjects were randomized and allocated in two groups: control group and study group. The control group received placebo plus cisplatin and was guided to ingest Placebo just before initial cisplatin dosage. The maximum cumulative cisplatin dosage was 300mg/m². They were followed up for ninety days. Comparisons were made between baseline distortion-product otoacoustic emissions measurements and those DPOAE records after maximum cumulative cisplatin dosage.
16232972|NCT01139255|Behavioral|Podcasting + mobile media|Use of a weight loss podcast designed with health behavior theory
16232973|NCT01139242|Behavioral|Body & Soul nutritional intervention|Pastoral and peer counseling, and church activities/menus to promote increased fruit and vegetable consumption among church members.
16232974|NCT01139242|Behavioral|Experimental: newsletters and peer counseling|Four tailored newsletters and peer counseling calls to promote CRC screening in church members who are out-of-date with screening. Four tailored newsletters and peer counseling calls to others to increase physical activity.
16232975|NCT01139229|Other|hybrid everted esophagogastric anastomosis|
16232976|NCT01139229|Other|the conventional hand-sewn anastomosis|
16232977|NCT01139229|Other|a stapled anastomosis|
16232978|NCT01139216|Drug|Daikenchuto (TU-100)|Subjects will receive 2.5g TID (7.5g/day) of TU-100. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 4 weeks.
16232979|NCT01139216|Drug|Daikenchuto (TU-100)|Subjects will receive 5g TID (15g/day) of TU-100. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 4 weeks.
16232980|NCT01139216|Drug|Placebo|Subjects will receive daily dose of TU-100 placebo. Dosage form is granule. Subject will take a daily dose divided 3 times per day for 4 weeks.
16232981|NCT01139203|Drug|lamivudine adefovir entecavir HBIG|lamivudine 100mg orally daily adefovir 10mg orally daily entecavir 0.5mg orally daily HBIG 2000 unit intravenously during the anhepatic phase,and followed 800 unit intramuscularly daily until day 14,then 400 unit intramuscularly twice weekly
16232982|NCT01139190|Drug|PL3100|Oral administration
16232983|NCT01139190|Drug|Naproxen|Oral administration
16232984|NCT01139177|Device|Stenting of atherosclerotic lesion(s)|Stenting of atherosclerotic lesions post pre-dilatation of lesion(s)
16232985|NCT01139164|Drug|Regimen A|Chronic Lymphocytic Leukemia/ Chronic Prolymphocytic Leukemia, Multiple Myeloma.
16232986|NCT01139164|Drug|Regimen B|Other malignancies not addressed in A or C
16232987|NCT01139164|Drug|Regimen C|B-Cell Lymphomas
16232988|NCT01139151|Drug|3 Day Thiarabine|Starting dose 70 mg/m^2 IV over 1 hour (±15 minutes) daily x 3
16232989|NCT01139151|Drug|5 Day Thiarabine|Starting dose 40 mg/m2 IV over 1 hour (±15 minutes) daily x 5
16232990|NCT01139138|Drug|Panitumumab|Panitumumab 6mg/kg IV every 14 days
16232991|NCT01139138|Drug|Irinotecan|Irinotecan 200mg/m2 IV every 14 days
16232992|NCT01139138|Drug|Everolimus|Everolimus daily po (dosage varies with cohort)
16232993|NCT01139125|Drug|(Cystagon) Cysteamine Bitartrate|Cysteamine Bitartrate 300mg/day to 2100mg/day over a 4 month period. Number of cycles: until progression or unacceptable toxicity develops.
16232994|NCT01139099|Behavioral|Group Psychotherapy|integrated group psychotherapy, including the interpersonal and cognitive group therapy
16232995|NCT01139060|Behavioral|organized care program for chronic or recurrent depression|
16232996|NCT01139047|Drug|metronidazole 1% gel|Apply topically once daily on one side of the face for three weeks
16232997|NCT01139047|Drug|azelaic acid 15% gel|Apply topically twice daily on the opposite side of the face for three weeks
16232998|NCT01139034|Device|Self-designed surface functional electrical stimulator|Use the self-designed surface functional electrical stimulator to improve the shoulder joint subluxation.
16232999|NCT01139021|Biological|rMenB+OMV NZ|Subjects will be assigned to a study group based on the group assignment in the parent study (follow-on subjects). In addition, one group of naïve age-matched subjects will be recruited at the same study sites. Subjects who had received 4 doses of rMenB+OMV NZ will have one visit including one blood draw. Subjects who had received two catch-up doses in V72P13E1 will receive a third dose boost and will have 3 blood samples drawn. Naïve subjects will receive two catch-up doses and have 3 blood samples drawn.
16233000|NCT01139008|Drug|metronidazole 1% gel|Apply topically on one side of the face once daily for three weeks
16233001|NCT01139008|Drug|azelaic acid 15% gel|Apply topically on the opposite side of the face twice daily for three weeks
16233002|NCT01138995|Device|Ness L300|The Ness L300 delivers functional electrical stimulation (FES), which improves gait function, stroke-specific quality of life, functionality, and safety for persons with stroke.
16233003|NCT01138995|Device|Ankle-foot orthosis|"The Control Group will walk with a usual ankle-foot orthosis (AFO)."
16233004|NCT01138982|Behavioral|Youth Mentoring program|
16233005|NCT01138969|Drug|esomeprazole|esomeprazole 20 mg qd for 6 months
16233006|NCT01138956|Drug|N-acetylcysteine|N-acetylcysteine (NAC), effervescent tablets of 600mg, tid, po, 28 days
16233007|NCT01138956|Drug|Pentavalent antimonial|Pentavalent antimonial, 20mg/kg/day, 28 days, IV
16233008|NCT01138943|Drug|Synthodont|"15 ml, tree times/day for 07 days
~Arm: Chlorhexidine alcohol-base mouthrinse"
16233009|NCT01138943|Drug|Soludent|"15ml of 01% Chlorhexidine non alcohol-based, 3 times a day for 7 days
~Arm: Experimental: non alcohol chlorhexidine mouthrinse"
16233010|NCT01138930|Drug|Berberine|1.5g daily for 3 month
16233011|NCT01138930|Drug|Placebo|placebo daily
16233012|NCT01138917|Device|ReCell and Split-thickness skin graft|The surgeon will be required to select two similar non-contiguous injury areas with both areas being at least 100cm2 and second degree depth/severity. One area will be treated using ReCell and the second using Split-thickness Skin Graft.
16233013|NCT01138904|Drug|irinotecan, oxaliplatin|"OXIR: FOLFOX -> FOLFIRI
~IROX: FOLFIRI -> FOLFOX
~FOLFOX REGIMEN
~D1 Oxaliplatin 85mg/m2 + 5DW 500ml MIV over 120min D1,D2 Leucovorin 50mg IV Push D1,D2 5-Fluorouracil 400mg/m2 IV Push D1,D2 5-Fluorouracil 600mg/m2 + 5DW 1000ml MIV over 22hr
~Every 2 weeks
~FOLFILI REGIMEN
~D1 Irinotecan 150mg/m2 + 5DW 500ml MIV over 120min D1,D2 Leucovorin 50mg IV Push D1,D2 5-Fluorouracil 400mg/m2 IV Push D1,D2 5-Fluorouracil 600mg/m2 + 5DW 1000ml MIV over 22hr
~Every 2 weeks"
16233057|NCT01138605|Drug|Darunavir|375 mg composed via oral solution or various tablets, twice daily in combination with ritonavir for body weight between 20 and 30 kg
16233058|NCT01138605|Drug|Ritonavir|Liquid formulation, 80 mg/ml, taken in combination with Darunavir
16233014|NCT01138904|Drug|oxaliplatin, irinotecan|"FOLFOX REGIMEN
~D1 Oxaliplatin 85mg/m2 + 5DW 500ml MIV over 120min D1,D2 Leucovorin 50mg IV Push D1,D2 5-Fluorouracil 400mg/m2 IV Push D1,D2 5-Fluorouracil 600mg/m2 + 5DW 1000ml MIV over 22hr
~Every 2 weeks
~FOLFILI REGIMEN
~D1 Irinotecan 150mg/m2 + 5DW 500ml MIV over 120min D1,D2 Leucovorin 50mg IV Push D1,D2 5-Fluorouracil 400mg/m2 IV Push D1,D2 5-Fluorouracil 600mg/m2 + 5DW 1000ml MIV over 22hr
~Every 2 weeks"
16233015|NCT01138878|Other|Questionnaire|Administration of written questionnaire to assess attitudes towards the introduction of routine HIV testing programmes to that healthcare setting
16233016|NCT01138878|Other|Focus Group Discussion|FGD to explore attitudes within each group towards the introduction of routine HIV screening programmes in each medical setting
16233017|NCT01138878|Other|HIV test (serum or salivary)|An HIV test offered to all 16-65 year olds (not known already to be HIV-positive) accessing the healthcare setting during the twelve week pilot period
16233018|NCT01138878|Other|Semi-structured telephone interview|Telephone interview administered to patients offered an HIV test during the pilot period
16233019|NCT01138865|Device|AutoSet Spirit--Wash--Modified-AutoSet Spirit|3 months of therapeutic CPAP (auto-titrating CPAP) followed by 3 months of non-therapeutic sham-CPAP with 1 month of wash-out in between
16233020|NCT01138865|Device|Modified-AutoSet Spirit--Wash-AutoSet Spirit|3 months of non-therapeutic sham-CPAP followed by 3 months of therapeutic CPAP (auto-titrating CPAP) with 1 month of wash-out in between
16233021|NCT01138852|Drug|Ampicillin-sulbactam|Patients were randomly assigned to receive either 1.5g of cefuroxime, or 3g of ampicillin/ sulbactam intravenously after the time the umbilical cord was clamped
16233022|NCT01138852|Drug|Cefuroxime|Patients were randomly assigned to receive either 1.5g of cefuroxime, or 3g of ampicillin/ sulbactam intravenously after the time the umbilical cord was clamped
16233023|NCT01138839|Drug|Dexamethasone|Pregnant women in the experimental group will receive 10-mg doses (2.5 cc) of dexamethasone sodium phosphate intravenously every 12 hours until delivery and 3 additional doses after delivery. Puerperal women will receive 3 10-mg doses after delivery.
16233024|NCT01138839|Drug|sterile water|Pregnant women will receive 2.5 cc of sterile water every 12 hours until delivery and 3 additional doses after delivery. Puerperal women will receive 3 doses after delivery
16233025|NCT01138826|Drug|Amlodipine - reference|10 mg tablet, single dose, with water
16233026|NCT01138826|Drug|Amlodipine ODT - test|10 mg orally disintegrating tablet (ODT), single dose, with water
16233027|NCT01138826|Drug|Amlodipine ODT - test|10 mg orally disintegrating tablet (ODT), single dose, without water
16233028|NCT01138787|Dietary Supplement|Reference spread|Single dose (30 gr) of spread, containing 2250 mg PS
16233029|NCT01138787|Dietary Supplement|Placebo spread|Single dose (30 gr) of regular light margarine
16233030|NCT01138787|Dietary Supplement|Test spread|Single dose (30 gr) of innovatively processed spread containing 2250 mg PS.
16233031|NCT01138774|Dietary Supplement|Double blind dietary intervention with EPA and lipoic acid|Placebo-controlled dietary intervention during 10 weeks. All groups will have a dietary treatment with a calorie restriction of 30 % the subject's energy expenditure at baseline, supplemented with eicosapentaenoic acid (EPA) and/or lipoic acid (LA).
16233033|NCT01138748|Radiation|hypofractionated radiation therapy|hypofractionated radiation therapy
16233034|NCT01138735|Drug|adapalene/benzoyl peroxide|daily topical application for 12 weeks
16233035|NCT01138735|Drug|Topical Gel Vehicle|daily topical application for 12 weeks
16233036|NCT01138722|Radiation|hypofractionated radiation therapy followed by surgery|hypofractionated radiation therapy followed by surgery
16233037|NCT01138709|Device|Vitala|Vitala™ Continence Control Device
16233038|NCT01138696|Other|Questionnaires|KOOS, IKDC, SF-36, Lysholm, Tegner, VAS),
16233039|NCT01138696|Other|RX|X-rays and clinical investigation of the knee 20 years after surgery
16233040|NCT01138683|Procedure|ultrafiltration|Ultrafiltration through double lumen catheter, via central vein (Vena jugularis interna or Vena femoralis, 11 French, 15 cm for right jugular or 20 cm for femoralis and jugularis left-position). Based on severity of fluid overload the cardiologist determines the ultrafiltration rate. 'Multifiltrate Fresenius' (extracorporeal blood volume 72ml) in SCUF (slow continuous ultrafiltration) modus with pediatric lines (54 ml extracorporeal volume in the AV-set) and a pediatric filter (Ultraflux® AV paed, blood volume 18ml). Heparin to maintain an APTT between 65 en 85 seconds during ultrafiltration.
16233041|NCT01138683|Drug|diuretics|Bumetanide continuous infusion to reach a prescribed negative fluid balance: dose adjustment according to the diuretic response.
16233042|NCT01138657|Biological|Adalimumab|Administered subcutaneously as an 80 mg loading dose (2 syringes) at Baseline followed by a 40 mg dose eow starting at Week 1.
16233043|NCT01138657|Drug|Prednisone|Administered orally, 60 mg/day at study entry followed by a protocol-defined mandatory taper schedule in which all participants continuing in the study were to discontinue prednisone no later than Week 15.
16233044|NCT01138657|Drug|Placebo|Administered by subcutaneous injection
16233045|NCT01138631|Device|Embryoscope|The embryoscope is an incubator with in-built photographic equipment
16233046|NCT01138618|Device|Venous blod sample|Regular venous blood sample withdrawn from the laboratory
16233047|NCT01138618|Device|CHEMPAQ|Capillary blood sample analyzed by CHEMPAQ
16233048|NCT01138605|Drug|Darunavir|600mg composed via oral solution or various tablets, twice daily in combination with ritonavir, for body weight as of 40 kg
16233049|NCT01138605|Drug|Ritonavir|Liquid formulation, 80 mg/ml, taken in combination with Darunavir
16233050|NCT01138605|Drug|Ritonavir|100 mg capsule, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
16233051|NCT01138605|Drug|Darunavir|Oral suspension 100 mg/ml, 20 mg/kg twice daily in combination with ritonavir for body weight between 10 and 20 kg
16233052|NCT01138605|Drug|Ritonavir|100 mg tablet, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
16233053|NCT01138605|Drug|Darunavir|375 mg composed via oral solution or various tablets, twice daily in combination with ritonavir for body weight between 20 and 30 kg
16233059|NCT01138605|Drug|Darunavir|450 mg composed via oral solution or various tablets, twice daily in combination with ritonavir for body weight between 30 and 40 kg
16233060|NCT01138605|Drug|Darunavir|600mg composed via oral solution or various tablets, twice daily in combination with ritonavir, for body weight as of 40 kg
16233061|NCT01138605|Drug|Ritonavir|100 mg capsule, to be taken once or twice daily in combination with Darunavir and following the Darunavir dosing schedule
16233062|NCT01138605|Drug|Ritonavir|Ritonavir powder for oral suspension 10 mg/mL taken in combination with Darunavir.
16233063|NCT01138579|Drug|FBTA05|
16233064|NCT01138553|Drug|Mifepristone|200mg capsules daily for 5-28 days
16233065|NCT01138540|Other|lateral-Trendelenburg position|lateral-Trendelenburg position of patients laying in the bed of the ICU, keeping trachea and tracheal tube horizontal, compared to the standard treatment (semirecumbent position) for the prevention of VAP
16233066|NCT01138527|Other|MRI examination|45-minute MRI examination of the prostate and surrounding tissues with T2-weighted MRI, diffusion-weighted MRI, Spectroscopic Imaging and dynamic contrast enhanced imaging
16233067|NCT01138514|Drug|Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo)|Applied to the entire face twice daily for 10 weeks
16233068|NCT01138514|Drug|Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin)|Applied to the entire face twice daily for 10 weeks
16233069|NCT01138514|Drug|Placebo|Placebo
16233070|NCT01138501|Drug|turoctocog alfa|Subjects will be treated 3 times per week or every second day with intravenous injections of turoctocog alfa. The dose range for preventive treatment is 25-60 IU/kg body weight depending on treatment regimen.
16233071|NCT01138501|Drug|turoctocog alfa|Subjects will undergo half-life evaluation of their current factor VIII product and pharmacokinetic session with turoctocog alfa before entering preventive treatment (subjects with available evaluation of terminal half-life within the last year are to be excluded from receiving factor VIII). Intravenous injections. The dose range for preventive treatment is 25-60 IU/kg body weight depending on treatment regimen.
16233072|NCT01138488|Drug|insulin degludec/insulin aspart|Insulin degludec/insulin aspart administered as a single subcutaneous injection (under the skin).
16233073|NCT01138475|Drug|Paricalcitol|1 microgram by mouth daily for 6 weeks
16233074|NCT01138475|Drug|Cholecalciferol|5000 IU (international units) by mouth daily for 6 weeks
16233075|NCT01138475|Drug|Placebo|Inactive substance, one capsule daily for 6 weeks
16233076|NCT01138462|Other|intervention|"5 days topical decolonisation including nasal mupirocin tid, chlorhexidine mouth wash tid, chlorhexidine body wash once daily.
~Daily direct resident's environmental disinfection during decolonisation."
16233077|NCT01138449|Drug|Vitamin A|Retinol palmitate (50,000 IU) and minute amounts of vitamin E in soybean oil, orally as a single dose to neonates on the day of birth or in the next 2 days of birth keeping a minimum period of 2 hours between the birth and the dosing
16233078|NCT01138436|Drug|MEBO Wound Ointment (MEBO)|Topical application once a day
16233079|NCT01138436|Procedure|Standard of Care|Application of Profore multilayer compression bandage system
16233080|NCT01138423|Drug|Aliskiren|Once daily treatment with aliskiren for 8-weeks, according to the following regiment: once daily (morning time) 150 mg during the first 2 weeks, followed by once daily (morning time) 300 mg during the remaining 6 weeks. Coincidental intake of grapefruit(juice) should be avoided. This treatment interval is followed by a one-week tapering period: 150 mg on day 1, 2, 3, 4, 5 and 7.
16233081|NCT01138423|Drug|Moxonidine|Once daily treatment with moxonidine for 8-weeks, according to the following regiment: once daily (morning time) 0.2 mg during the first 2 weeks, followed by once daily (morning time) 0.4 mg during the remaining 6 weeks. Coincidental intake of grapefruit(juice) should be avoided. This treatment interval is followed by a one-week tapering period: 0.2 mg on day 1, 2, 3, 4, 5 and 7.
16233082|NCT01138423|Drug|Hydrochlorothiazide|Once daily treatment with hydrochlorothiazide for 8-weeks, according to the following regiment: once daily (morning time) 12.5 mg during the first 2 weeks, followed by once daily (morning time) 25 mg during the remaining 6 weeks. Coincidental intake of grapefruit(juice) should be avoided. This treatment interval is followed by a one-week tapering period: 12.5 mg on day 1, 2, 3, 4, 5 and 7.
16233083|NCT01138423|Drug|Placebo (for aliskiren)|Once daily treatment with placebo tablets for 8-weeks, according to the following regiment: once daily (morning time) 1 tablet during the first 2 weeks, followed by once daily (morning time) 2 tablets during the remaining 6 weeks. Coincidental intake of grapefruit(juice) should be avoided. This treatment interval is followed by a one-week tapering period: 1 tablet on day 1, 2, 3, 4, 5 and 7.
16233084|NCT01138423|Drug|Placebo (for moxonidine and hydrochlorothiazide)|Once daily treatment with placebo capsules for 8-weeks, according to the following regiment: once daily (morning time) 1 capsule during the first 2 weeks, followed by once daily (morning time) 2 capsules during the remaining 6 weeks. Coincidental intake of grapefruit(juice) should be avoided. This treatment interval is followed by a one-week tapering period: 1 tablet on day 1, 2, 3, 4, 5 and 7.
16233085|NCT01138410|Biological|SCIB1|Aqueous solution of plasmid DNA administered by intramuscular injection using the TDS-IM electroporation device (Ichor Medical Systems, Inc.) at week 0, 3, 6, 12 and 24. Part 1 of the study will escalate through 0.4, 2.0, 4.0 and 8.0 mg dose level cohorts, each of three patients. In Part 2 of the study the 4.0 and 8.0 mg doses will be administered in the same regimen. At the discretion of the investigator, patients in both parts of the study may continue to receive SCIB1 at 3-6 month intervals for 5 years.
16233086|NCT01138397|Biological|Influenza virus vaccine (split virion, inactivated)|0.1 mL, Intradermal
16233087|NCT01138397|Biological|Influenza virus vaccine (split virion, inactivated)|0.1 mL, Intradermal
16233088|NCT01138384|Drug|Foretinib|Daily oral dosing at assigned dose beginning day 3 of cycle 1
16233089|NCT01138384|Drug|Lapatinib|Daily oral dosing at assigned dose beginning day 1 cycle 1.
16233090|NCT01138371|Procedure|LDL Apheresis|LDL Apheresis
16233091|NCT01138358|Other|medical chart review|
16233092|NCT01138358|Other|study of socioeconomic and demographic variables|
16233093|NCT01138358|Other|survey administration|
16233094|NCT01138358|Procedure|quality-of-life assessment|
16233095|NCT01138345|Genetic|gene expression analysis|blood samples will be analyzed for the expression of the p16 gene.
16233096|NCT01138345|Genetic|reverse transcriptase-polymerase chain reaction|perform reverse transcriptase-polymerase chain reaction on all blood samples.
16233097|NCT01138345|Other|laboratory biomarker analysis|perform laboratory biomarker analysis on all blood samples
16233098|NCT01138345|Other|medical chart review|perform medical chart review for all subjects
16233099|NCT01138345|Other|questionnaire administration|each cohort will be given the same questionnaire
16233100|NCT01138332|Genetic|western blotting|
16233101|NCT01138332|Other|laboratory biomarker analysis|
16233102|NCT01138319|Genetic|DNA analysis|
16233103|NCT01138319|Genetic|mutation analysis|
16233104|NCT01138319|Genetic|polymerase chain reaction|
16233105|NCT01138319|Other|laboratory biomarker analysis|
16233106|NCT01138306|Genetic|gene expression analysis|
16233107|NCT01138306|Genetic|mutation analysis|
16233108|NCT01138306|Other|flow cytometry|
16233109|NCT01138306|Other|laboratory biomarker analysis|
16233110|NCT01138293|Device|motion detection with a motion sensor|To asses physical activity and eating habits electronic health technology was used (Fraunhofer-Institute). The system consists in a motion sensor integrated in a mobile phone (DiaTrace). The system analyses kind, intensity and duration of physical activity and eating habits.
16233111|NCT01138280|Device|CWP 103H (Gambro, Sweden): a heat disinfection device|Heat disinfection can increase temperature to 95c in the RO water treatment system and then in the piping system link to dialysis machines in each hemodialysis center per night
16233112|NCT01138254|Device|WSTM TY101 FIR emitter (Far infrared therapy)|A WSTM TY101 FIR emitter (WS Far Infrared Medical Technology Co., Ltd., Taipei, Taiwan) will be used for FIR therapy. The electrified ceramic plates of this emitter generate electromagnetic waves with wavelengths in the range between 3 and 25 μm (a peak between 5 to 6 μm). The irradiating power density is 10 and 20 mili watt<mw>/cm2 when the top radiator is set at a distance between 30 and 20 cm above the skin surface respectively. In this study, the top radiator will be set at a height of 25 cm above the surface of bilateral lower legs and the treatment time will be set at 40 minutes three times weekly (TIW) for ESRD patients for 6 months.
16233113|NCT01138254|Other|no intervention|no intervention
16233114|NCT01138241|Other|Tc99mDTPA renal clearance|"Tc99mDTPA renal clearance only for 200 patients
~Plasma and urine 24 hr for creatinin, glucose, Creatinin clearance, Phosphatemia, uric acid, HCO3, protein, Microalbuminuria, ß2- microglobulinuria
~serum creatinine prior and during TDF
~TDF plasma levels ( only TDF use) using a validated high-performance liquid chromatography (HPLC)-mass method and stored PBMC for intracellular TDF levels
~stored samples (PBMC) for pharmacogenomic study of transporter gene ie Organic Acid Transporter (OAT)
~serum for cystanin C ( stored sample prior taking ARV and present time)
~intensive 24 hours pharmacokinetic study of TDF in 20 patients"
16233115|NCT01138215|Biological|VZV vaccination|Dose : 0.5 ml Route : subcutaneous injection (SC)
16233116|NCT01138202|Drug|LPV/r|LPV/r 400/100 mg BID + 2 NRTI for arm 1 (total 48 weeks) LPV/r 600/150 mg BID + 2 NRTI for arm 2 (total 48 weeks)
16233117|NCT01138189|Procedure|Wavefront-guided LASIK|Wavefront-guided LASIK in one eye using the Allegretto excimer laser
16233118|NCT01138189|Procedure|Wavefront-optimized LASIK|Wavefront-optimized LASIK in one eye using the Allegretto excimer laser
16233119|NCT01138176|Procedure|Cooling|Reduction of rectal temperature to 33.5 C
16233120|NCT01138163|Drug|Docetaxel plus bavituximab or placebo|Patients will be randomized to receive docetaxel plus placebo, docetaxel plus 1 mg/kg bavituximab, or docetaxel plus 3 mg/kg bavituximab in the Combination Therapy Period. The Combination Treatment Period for each patient will begin on Study Day 1. Docetaxel, 75 mg/m2, will be given on Day 1 of each 21 day cycle for up to 6 cycles, and placebo or the assigned dose of bavituximab will be given weekly. Docetaxel administration will occur every 21 days. All patients who complete the Combination Therapy Period (or discontinue for any reason other than disease progression or toxicity) will be eligible to enter the Monotherapy Period. Patients will continue to receive assigned blinded treatment (placebo or 1 or 3 mg/kg bavituximab) weekly until progression or toxicity.
16233121|NCT01138150|Drug|Treximet|One tablet of sumatriptan 85 mg and naproxen sodium 500 mg will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.
16233122|NCT01138150|Drug|Placebo|One tablet of a sugar pill will be given upon subject presentation with an acute migraine attack and after blood levels have been drawn.
16233123|NCT01138137|Drug|Paclitaxel|"Dose: 135mg/m2 infused IV on Day 1 of 3 week cycle
~Dose: 60mg/m2 infused IP on Day 8 of 3 week cycle
~6 treatment cycles"
16233124|NCT01138137|Drug|N-acetylcysteine|"A group of 5 subjects will be evaluated at each dose level.
~On Day 2 of each 3 week cycle, subject receives IV NAC followed by IP cisplatin.
~6 treatment cycles
~Dose escalation schema:
~Level 1: 150mg/kg
~Level 2: 300mg/kg
~Level 3: 600mg/kg
~Level 4: 800mg/kg
~Level 5: 1000mg/kg
~Level 6: 1200mg/kg"
16233125|NCT01138137|Drug|Cisplatin|"Dose: 100mg/m2 infused IP on day 2 of each 3 week cycle 60 min after the NAC infusion
~6 treatment cycles"
16233126|NCT01138124|Drug|Gabapentin prescriptions|The exposure of interest is gabapentin use as defined by prescriptions recorded by the GPRD general practitioner (British National Formulary codes). Data on prescriptions for gabapentin will be extracted for each case and control from entry into the study cohort up to the index date (the exposure window). Gabapentin exposure will be parameterized as follows: (1) Ever versus never exposed; (2) Number of prescriptions; (3) Duration of exposure; and (4) Cumulative dose. These parameterizations will also be examined with a 2 year lag time from the index date, limiting the exposure window from entry into the study cohort up to 2 years prior to the index date.
16233127|NCT01138111|Drug|Florbetaben (BAY94-9172)|single 300 megabecquerel (MBq) intravenous injection 2 mL to 10 mL, at baseline, at 12 and 24 months
16233128|NCT01138098|Biological|Engerix™-B|Intramuscular, single dose
16233129|NCT01138085|Drug|GSK1120212|MEK inhibitor
16233130|NCT01138085|Drug|GSK2141795|AKT Inhibitor
16233131|NCT01138072|Drug|GSK2248761|200mg once daily
16233132|NCT01138072|Drug|Simvastatin|20 mg Simvastatin single dose
16233133|NCT01138072|Drug|Atorvastatin|20 mg atorvastatin single dose
16233134|NCT01138072|Drug|Rosuvastatin|10 mg rosuvastatin single dose
16233180|NCT01137773|Drug|Conventional insulin treatment|All patients in the trial will have blood taken hourly for glucose analysis , regardless of their designated group. Adjustments of the insulin dose will be based on measurements of capillary blood glucose level.
16233181|NCT01137760|Dietary Supplement|Sucrose|5 g of sucrose daily for 8 weeks
16233135|NCT01138046|Drug|Lapatinib in combination with weekly paclitaxel|These subjects will receive weekly paclitaxel (80 mg/m2 IV for 3 weeks in a 4 week cycle) plus lapatinib (1500 mg once daily, starting on the second day of phase I). Subjects will receive a daily dose of lapatinib until disease progression or withdrawal from study treatment due to unacceptable toxicity or withdrawal of consent. Study completion is defined as deaths after administering study treatment for more than once. Subjects will be treated with paclitaxel for standard of 6 cycles, and may be continued at the discretion of investigators. If the subject experiences progression, an unacceptable toxicity related to paclitaxel, or termination of lapatinib therapy, paclitaxel therapy must be terminated any time of study period, even before 6 cycles of paclitaxel are given.
16233136|NCT01138033|Drug|GSK2256098|GSK2256098 is a potent focal adhesion kinase inhibitor that will be administered orally as 20, 100 or 250 mg capsules. The starting dose in Part 1 is 80 mg twice daily. The dose will continue to be increased until the maximum tolerated dose is identified.
16233137|NCT01138020|Behavioral|Cognitive Intervention|Cognitive rehabilitation treatment designed specifically to address the most common cognitive complaints in executive and memory function
16233138|NCT01138020|Behavioral|Educational intervention|Educational intervention is geared at personal management of TBI-related symptoms.
16233139|NCT01138007|Drug|323U66 SR 150 mg tablet|323U66 SR 150 mg tablet is orally administered once in the morning and/or once in the evening during the teatment phase.
16233140|NCT01138007|Drug|323U66 SR 150 mg placebo tablet|323U66 SR 150 mg placebo tablet is orally administered once in the evening and/or once in the morning during the teatment phase.
16233141|NCT01137994|Drug|Lapatinib|oral, reversible small molecule tyrosine kinase inhibitor of HER2 receptor
16233142|NCT01137994|Biological|Trastuzumab|monoclonal antibody directed to HER2 receptor
16233143|NCT01137994|Drug|Docetaxel|Taxane chemotherapy
16233144|NCT01137994|Drug|Paclitaxel|Taxane chemotherapy
16233145|NCT01137994|Drug|Vinorelbine|Vinka alkaloid
16233146|NCT01137981|Drug|Any Antiretroviral Therapy|Any exposure to an antiretroviral therapy: Abacavir, Amprenavir, Delavirdine, Fosamprenavir, Lamivudine, Maraviroc, Zidovudine, Combivir (Zidovudine+Lamivudine), Epzicom (Abacavir+Lamivudine), and/or Trizivir (Abacavir+Lamivudine+Zidovudine)
16233147|NCT01137968|Drug|imetelstat|9.4 mg/kg over a 2 hour IV infusion on Day 1 and Day 8 of each 21 day cycle until disease progression.
16233148|NCT01137968|Drug|Bevacizumab|Dosage and duration will be according to the FDA-approved bevacizumab package insert. Bevacizumab will be administered on Day 1 of each 21-day cycle.
16233149|NCT01137955|Drug|Rifaximin|Rifaximin 400mg orally three times a day for 10 days total
16233150|NCT01137955|Drug|Placebo|Placebo orally three times a day for 10 days total
16233151|NCT01137942|Drug|clarithromycin, metronidazole, proton pump inhibitor|appropriate dose of antibiotics and proton pump inhibitor
16233152|NCT01137916|Drug|Imatinib|800 mg
16233153|NCT01137903|Procedure|Conservative surgery|Osteotomy, phalangectomy, exostectomy, metatarsal head resection, articular resection, partial calcanectomy
16233154|NCT01137903|Drug|Ciprofloxacin|500 mg/ 12 hours during 90 days
16233155|NCT01137903|Drug|Amoxicillin-Potassium Clavulanate Combination|875/125 mg/12 hours during 90 days
16233156|NCT01137903|Drug|Sulfamethoxazole trimethoprim|Trimethoprim 160 mg / Sulfamethoxazole 800 mg 1/12 horas.
16233157|NCT01137890|Drug|Zonisamide|Eight capsules administered daily in split doses at 22:00 and 09:00.
16233158|NCT01137890|Drug|Placebo|capsules administered in split doses at 22:00 and 09:00.
16233159|NCT01137890|Drug|Cocaine Hydrochloride|Cocaine Challenge Sessions: Human laboratory sessions with administration of moderate doses of cocaine by the intravenous route under controlled conditions and cardiovascular monitoring.
16233160|NCT01137890|Behavioral|Neurocognitive and Performance Battery|Participants will complete tests to assess their abilities and performances on a number of tasks given by a computer or other type of equipment.
16233161|NCT01137890|Behavioral|Smoking Assessments|Participants answer questions about smoking and smoking behaviors are monitored.
16233162|NCT01137877|Other|Milk based infant formula powder|milk based infant formula ad lib
16233163|NCT01137877|Other|Investigational Infant Formula #1|Milk based infant formula ad lib
16233164|NCT01137877|Other|Investigational Infant Formula #2|Milk based infant formula powder ad lib
16233165|NCT01137877|Other|Human Milk|Human milk ad lib
16233166|NCT01137864|Other|Infectious disease specialist advice|Indication, choice, dosing and duration of antimicrobial therapy
16233167|NCT01137812|Drug|Sitagliptin 100 mg|One 100 mg capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea
16233168|NCT01137812|Drug|Canagliflozin 300 mg|One 300 mg capsule once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea
16233169|NCT01137812|Drug|Metformin|Patients will continue to take background therapy with Metformin for T2DM at maximally or near-maximally effective protocol-specified doses for the duration of the study.
16233170|NCT01137812|Drug|Sulphonylurea|Patients will continue to take background therapy with Sulphonylurea for T2DM at maximally or near-maximally effective protocol-specified doses for the duration of the study.
16233171|NCT01137799|Drug|JNJ-39393406|50mg nanosuspension (sort of liquid formulation) once daily (single dose)
16233172|NCT01137799|Drug|placebo|Once daily (single dose)
16233173|NCT01137799|Drug|JNJ-39393406|200mg nanosuspension (sort of liquid formulation) once daily (single dose)
16233174|NCT01137799|Drug|JNJ-39393406|100mg nanosuspension (sort of liquid formulation) once daily (single dose)
16233175|NCT01137799|Drug|JNJ-39393406|10mg nanosuspension (sort of liquid formulation) once daily (single dose)
16233176|NCT01137799|Drug|JNJ-39393406|30mg nanosuspension (sort of liquid formulation) once daily (single dose)
16233177|NCT01137786|Drug|Non ionic contrast media comparator|One time administration for PCI
16233178|NCT01137786|Drug|Non ionic contrast media comparator|one time administration for PCI
16233179|NCT01137773|Drug|Insulin|All patients in the trial will have blood taken hourly for glucose analysis, regardless of their designated group. Adjustments of the insulin dose will be based on measurements of capillary blood glucose level.
16233182|NCT01137760|Dietary Supplement|Galactooligosaccharide|2.5 g galactooligosaccharide plus 2.5 g sucrose daily for 8 weeks
16233183|NCT01137760|Dietary Supplement|Galactooligosaccharide|5.0 g galactooligosaccharide daily for 8 weeks
16233184|NCT01137747|Drug|Carfilzomib|
16233185|NCT01137734|Device|Adjustable Annuloplasty Ring with option to adjust off pump.|Annuloplasty device repair of mitral valve regurgitation with option to adjust device post implant off pump, to optimize correction of mitral regurgitation. Unlike conventional annuloplasty rean, the Cardinal system offers the clinician the opportunity to make adjustments after weaning from cardiopulmonary bypass. Adjustability is expected to reduce the number of patients leaving the operating room with residual regurgitation after mitral valve repair.
16233186|NCT01137734|Device|Device: Adjustable Annuloplasty Ring (with option to adjust off-pump)|Evaluate the performance and safety of the investigational adjustable annuloplasty ring device for the treatment of mitral regurgitation, with option to adjust on and off-pump.
16233187|NCT01137708|Drug|ethinyloestradiol (EE) and levonorgestrel (LN), CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN)|Period 1: 30 mcg ethinyloestradiol and 150 mcg levonorgestrel alone Period 2: 30 mcg ethinyloestradiol and 150 mcg levonorgestrel plus 30 mg CP-690,550 after 9 days of CP-690,550 at 30 mg BID
16233188|NCT01137708|Drug|CP-690,550 + ethinyloestradiol (EE) and levonorgestrel (LN), ethinyloestradiol (EE) and levonorgestrel (LN)|Period 1: 30 mcg ethinyloestradiol and 150 mcg levonorgestrel plus 30 mg CP-690,550 after 9 days of CP-690,550 at 30 mg BID Period 2: 30 mcg ethinyloestradiol and 150 mcg levonorgestrel alone
16233189|NCT01137695|Drug|Pramlintide|120 mcg SQ three times daily for 6 months.
16233190|NCT01137695|Drug|Pramlintide|360 mcg SQ three times daily for 6 months
16233191|NCT01137695|Drug|Pramlintide|120 mcg SQ three times daily for 6 months
16233192|NCT01137695|Drug|Pramlintide|360 mcg SQ three times daily for 6 months
16233193|NCT01137682|Drug|Pasireotide|"Double-blind pasireotide LAR 40 mg i.m. injection once every 28 ± 2 days for 24 weeks or
~Double-blind pasireotide LAR 60 mg i.m. injection once every 28 ± 2 days for 24 weeks"
16233194|NCT01137682|Drug|octreotide LAR 30mg|In an open-label, active control arm, continue on the same treatment with octreotide LAR 30 mg every 28 ± 2 days as received for at least 6 months prior to randomization
16233195|NCT01137682|Drug|lanreotide ATG 120mg|In an open-label, active control arm, continue on the same treatment with lanreotide ATG 120 mg every 28 ± 2 days as received for at least 6 months prior to randomization
16233196|NCT01137669|Biological|Live attenuated herpes zoster vaccine|ZOSTAVAX® (Zoster Vaccine Live) is a live attenuated vaccine provided as a single-dose, sterile, lyophilized, preservative-free frozen formulation. The vaccine will be supplied in 3-mL glass vials. Sterile diluent will be used to reconstitute study vaccine. The reconstituted vial will be gently agitated to mix thoroughly. The entire contents of the reconstituted vaccine vial (approximately 0.65 mL) will be withdrawn into a syringe. The vaccine will be administered immediately subcutaneously in the deltoid region.
16233197|NCT01137669|Other|Placebo|Placebo for Zoster Vaccine Live (ZOSTAVAX®) is sterile normal saline which will be obtained from the Fisher Repository in single-dose containers. 0.9% Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride and water for injection. The placebo will be administered subcutaneously in the deltoid region.
16233198|NCT01137656|Drug|Acetylcholine and Blood|The Acetylcholine solution will be infused intra-arterially at the dosage of 7.5 ug/min for 3 minutes, then 15ug/min for 3 minutes, then 30 ug/min for 3 minutes, after the infusion of normal saline. It will then be infused at 7.5ug/min for 3 minutes, followed by 15ug/min for 3 minutes, followed by 30 ug/min for 3 minutes after the infusion of autologous blood. This will be performed at 5-10 days and 35-42 days of blood storage time.
16233199|NCT01137643|Other|biologic sample preservation procedure|All samples collected during routine clinical care.
16233200|NCT01137643|Other|cytology specimen collection procedure|All Samples collected during routine clinical care.
16233201|NCT01137630|Drug|K40a|One tablespoon is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week.
16233202|NCT01137630|Drug|K40b|One tablespoon is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week.
16233203|NCT01137630|Drug|Placebo|One tablespoon is to be applied to affected areas of the scalp once daily for 4 weeks. Thereafter, a maintenance phase of 4 weeks is to follow with application 3 times per week.
16233204|NCT01137604|Drug|Lenvatinib|24 mg lenvatinib capsules orally, once daily continuously in 28-day cycles until disease progression, development of unacceptable toxicity or withdrawal of consent.
16233205|NCT01137604|Drug|Bevacizumab|Bevacizumab 10 mg/kg administered intravenously every 2 weeks in 28-day cycles until disease progression, development of unacceptable toxicity or withdrawal of consent.
16233206|NCT01137591|Drug|APAP and NAC combination|APAP 650mg and NAC 600mg combination oral tablet administered once
16233207|NCT01137591|Drug|APAP and Placebo|APAP 650mg and Placebo combination oral tablet administered once
16233208|NCT01137578|Procedure|Ultrasound|Ultrasounds to be performed on children with central venous catheters
16233209|NCT01137578|Drug|Magnetic Resonance Imaging with Contrast|Contrast-enhanced Magnetic Resonance Imaging (MRI) to be performed on children with central venous catheters
16233210|NCT01137578|Procedure|Magnetic Resonance Imaging without Contrast|Magnetic Resonance Imaging (MRI) to be performed on children with central venous catheters
16233211|NCT01137565|Drug|AMG 853|Single dose administration of AMG 853 or placebo in tablet form to adolescent and adult subjects with asthma
16233212|NCT01137565|Drug|Placebo|Placebo to AMG 853
16233213|NCT01137552|Drug|AMG 780|AMG 780 will be administered by IV infusion every 2 weeks
16233214|NCT01137539|Device|Gynecare TVT-SECUR system|All patients in the study will receive the Gynecare TVT-SECUR to treat stress urinary incontinence
16233215|NCT01137526|Drug|ABT-384|Subjects will take study drug once daily for 12 weeks
16233216|NCT01137526|Drug|donepezil|Subjects will take study drug once daily for 12 weeks.
16233217|NCT01137526|Drug|placebo|Subjects will take study drug once daily for 12 weeks
16233218|NCT01137513|Device|Observational Measurement of T-wave Alternans|Measurement is similar to typical EKG
16233219|NCT01137513|Device|T-wave Alternans|T-Wave Alternans will be measured in an observational fashion
16233884|NCT01132313|Drug|BI 207127|16 weeks, high dose, TID
16233220|NCT01137487|Procedure|monitoring of residual gastric volume|measurements of residual gastric volume every six hours in patients receiving early enteral feeding and mechanical ventilation
16233221|NCT01137487|Procedure|not monitoring of residual gastric volume|no measurements of residual gastric volume
16233222|NCT01137474|Drug|Dapagliflozin|Oral tablets administered as 2.5, 5, or 10 mg, once daily for up to 12 weeks
16233223|NCT01137474|Drug|Placebo-matching dapagliflozin|Oral tablets administered as 0 mg once daily for up to 12 weeks
16233224|NCT01137461|Procedure|ultrasound-guided embryo transfer|Embryo transfer in oocyte recipients
16233225|NCT01137448|Behavioral|Weight Loss|Subjects will enroll in a weight loss program and participate in weight loss counseling 6 times over the course of 6 months.
16233226|NCT01137435|Biological|ADACEL™:Adsorbed Diphtheria, Tetanus Toxoids and Component Pertussis Combined|0.5 mL, intramuscular (IM)
16233227|NCT01137396|Drug|Modafinil|Modafinil 400mg PO QDaily following up-titration for ~8weeks
16233228|NCT01137396|Behavioral|Cognitive Behavioral Therapy|Once weekly cognitive behavioral therapy for cocaine dependence
16233229|NCT01137383|Drug|Pegaferon (pegylated interferon alpha 2a) + ribavirin|pegylated interferon 180 micrograms subcutaneously weekly - ribavirin (oral, in two divided daily doses) 800 mg for genotype 2 and 3, 1000 or 1200mg (weight less than or greater than 75kg) for genotypes 1 and 4 - Duration: 24 weeks for genotype 2 and 3, 48 weeks for genotypes 1 and 4
16233230|NCT01137357|Dietary Supplement|Yoghurt with L. plantarum strain|Intake of yoghurt during 4 weeks
16233231|NCT01137357|Dietary Supplement|Yoghurt with L.casei|Intake of yoghurt during 4 weeks
16233232|NCT01137357|Dietary Supplement|Yoghurt with L. plantarum strain|Intake of yoghurt during 4 weeks
16233233|NCT01137357|Dietary Supplement|Yoghurt with L. plantarum strain|Yoghurt with L. plantarum strain
16233234|NCT01137357|Dietary Supplement|Yoghurt with L. plantarum strain|Intake of yoghurt during 4 weeks
16233235|NCT01137357|Dietary Supplement|Yoghurt|Intake of yoghurt during 4 weeks
16233236|NCT01137331|Drug|K301|Liquid- applied once daily prior to bed
16233237|NCT01137331|Drug|Placebo|Liquid- applied once daily prior to bed
16233238|NCT01137318|Behavioral|Cognitive remediation and Parent Training|Cognitive Intervention is CogMed Working Memory Training program, which is a 5-week, 5days/week computerized training program completed at home. The Parent Training is a 2.0 hour, weekly, group sessions that focus on behavioral management procedures.
16233239|NCT01137305|Other|VR- training|"Prospective randomization if 50 subjects to either three months of structured VR- training or no training; basic VR- skills assessment and a serial assessment of defined soft skills: self- efficacy, stress- coping and motivation prior to randomization; basic VR- skills measured within seven modules of the VR- simulator LapSim®: camera and instrument navigation, coordination, grasping, lifting and grasping, clip applying and diathermy cutting in different levels of difficulty- medium and hard referring to time to complete task, economy of instrument motion and tissue damage; intervention group: sessions of 45 minutes each twice a week for three months; control group: no training"
16233240|NCT01137292|Drug|voriconazole (VFEND®)|The use and dosage recommendations for voriconazole (VFEND®) will take place on the basis of the Summary of Product Characteristics (SmPC) and will be adjusted solely according to medical and therapeutic necessity. The formulation and dose will be managed by the treating physician according to the SmPC, disease and clinical situation. According to the SmPC, in the adults the treatment should be started with the loading dose of 6 mg/kg of voriconazole iv. every 12 hours (during the first 24 hrs) followed by the maintenance dose of 4 mg/kg BID. For peroral formulations, the initial dose should be depending on the weight of the patient 400 mg or 200 mg BID during the first 24 hrs, followed by the maintenance dose of 200 mg or 100 mg of voriconazole BID respectively For paediatric population (<12 years of age), there is no initial dose necessary. Depending on the formulation, the daily dosage should be in children 7 mg/kg iv. BID or 200 mg of voriconazole orally BID.
16233241|NCT01137266|Device|TENS|TENS
16233242|NCT01137253|Drug|Trimethaphan|Trimethaphan 4 mg/min IV, for the duration of the study (approximately 2 hours)
16233243|NCT01137253|Drug|Placebo|Response to intrabrachial vasodilators during IV saline infusion
16233244|NCT01137240|Procedure|gastric emptying scan|"subjects will eat a solid meal (scrambled eggs, etc) or drink liquid (water or juice) mixed with approximately 0.5 millicuries of radioactive material. A scanner/external gamma camera will be placed over the subject's stomach at 15 minute intervals for a duration of 90 minutes (monitoring the amount of radioactivity in the stomach). As the radioactively-labeled food empties from the stomach, the amount of radioactivity in the stomach decreases. The rate at which the radioactivity leaves the stomach reflects the rate at which food is emptying from the stomach. The radioisotope has a half life of approximately. 6 hours and is totally eliminated from the body within 24 hours.
~In subjects with gastroparesis, the food and the attached radioactive material remain in the stomach longer than normal (usually hours) before emptying into the small intestine. As a result, the scanner continues to show radioactivity in the area of the stomach for hours after the test meal."
16233245|NCT01137214|Device|Non-invasive positive pressure ventilator|All patients will initially be treated with CPAP for 12 weeks as part of usual clinical treatment for sleep apnea. A sleep study will be conducted after this and prior to randomization into the study. If this repeat sleep study demonstrates persistent central sleep apnea, patients will be randomized into 2 study groups. Group 1 - CPAP for 24 weeks. Group 2 - first 12 weeks CPAP (Continuous Positive Airway Pressure. Next 12 weeks - (ASV) Adaptive Servo ventilation. If the treatment is not working well at 12 weeks the participant/patients have the option of switching to the alternate treatment. Patients will be notified if they are to be switched to ASV. Participants will be asked to fill in the Epworth Sleepiness Score Questionnaire and Sleep Apnea Quality of Life Index form at 12 and 24 weeks.
16233246|NCT01137201|Procedure|Suturing of mesenteric defects|
16233247|NCT01137188|Dietary Supplement|Low calorie diet|Low calorie diet containing 800-1000 kcal/day
16233274|NCT01136980|Other|Sham placebo procedure|The Sham Procedure (control) will consist of an upper GI endoscopy that will be conducted under general anesthesia in an operating room. The surgical team will follow the same steps before, during, and after the sham procedure similar to the TIF procedure, except they will never insert the EsophyX device into the patient. The endoscope will be manipulated for 30-45 min as if the device were around it to simulate the effect of many rotations and manipulations on the esophagus.
16233885|NCT01132313|Drug|BI 207127|28 weeks, high dose, TID
16233248|NCT01137149|Behavioral|Behavioral Activation Therapy|Behavioral activation is a 12 week psychotherapeutic intervention utilizing a semi-structured format. Initial sessions focus on specific areas (Assessment and orientation, Activation, Problem Solving, Goal Setting, Overcoming Barriers, Avoidance) interspersed as needed by sessions that focus on individual issues and applications. In these sessions the therapists maintains the session structure, but can use techniques presented in earlier sessions based on their functional analysis of the particular case. Parents participate in at least two of the ATA sessions but more active parental participation can be included as needed.
16233249|NCT01137149|Behavioral|Treatment as Usual- Psychotherapy|The TAU condition will be implemented consistent with usual and customary clinical practices within the Child Psychiatry Clinic at Seattle Children's Hospital (SCH. Within the SCH system, TAU for a depressed adolescent will typically consist of an individual therapy approach with adjunct family sessions and pharmacotherapy as deemed necessary by the primary therapist. The therapeutic approach typically used is cognitive behavioral but is administered in an eclectic, non-manualized fashion. Therapists for the TAU arm of the study will be care providers currently working within the SCH system. For this phase of the study, we will draw on clinicians whose level of experience is comparable to that of the Behavioral Activation therapists.
16233250|NCT01137123|Drug|adjuvant chemotherapy|Docetaxel 75mg/m2 +Nedaplatin 75mg/m2,IV drip on day 1 of each 21 day cycle. Number of cycles: till unacceptable toxicity develops and no more than 4 cycles.
16233251|NCT01137123|Procedure|standard two field Lymphadenectomy|Standard two field lymphadenectomy is standard mediastinal lymphadenectomy which defined by the International Association of esophageal disease(ISDE) of thoracic esophageal cancer.
16233252|NCT01137123|Procedure|Total two field Lymphadenectomy|Total two field Lymphadenectomy is total mediastinal lymphadenectomy which defined by the International Association of esophageal disease(ISDE) of thoracic esophageal cancer.
16233253|NCT01137123|Procedure|three field Lymphadenectomy|Three field Lymphadenectomy includes abdominal,mediastinal and cervical lymphadenectomy.
16233254|NCT01137110|Other|Brief LEV|Levetiracetam 1000mg BID x 3 days for prophylaxis
16233255|NCT01137110|Other|Extended LEV|Levetiracetam 1000mg BID for length of hospital stay for prophylaxis
16233256|NCT01137097|Procedure|Lateral sentinel lymph node biopsy|Sentinel lymph node biopsy with radioisotope. Isotope injection and lymphoscintigraphy preoperatively
16233257|NCT01137084|Drug|solu medrol|total dose 20mg/kg, including first dose 10mg/kg, rest of drug given within one weeks after liver transplantation
16233258|NCT01137084|Drug|a steroid-free immunosuppression protocol|receive immunosuppression with Basiliximab(20mg/day,twice following transplantation) and tacrolimus(0.06/kg/d,twice a day) without steroids.
16233259|NCT01137071|Biological|Monoclonal antibody Hu3S193|"30 mg/m2 of Monoclonal antibody Hu3S193, IV as a single agent every two weeks, in a total of 12 doses (treatment period duration: 23 weeks). Anti-Lewis Y humanized monoclonal antibody designated orphan drug by the FDA on March 09, 2012 for the treatment of ovarian cancer, not yet approved for the orphan designation."
16233260|NCT01137058|Device|U-healthcare service|Public switched telephone network (PSTN)-connected glucometer with U-healthcare system.
16233261|NCT01137058|Device|SMBG group|Glucose control with self monitoring of blood glucose.
16233262|NCT01137045|Biological|SPEEDA and TRCS SPEEDA|"For modified TRC-ID regimen,0.1 ml of SPEEDA, TRCS SPEEDA or VERORAB will be given at each of two sites,intradermally on upper arms on days 0,3,7 and 28.
~For ESSEN regimen, 1 vial of SPEEDA will be given intramuscularly at upper arm on days 0,3,7,14 and 28.
~For ERIG,it would be given in a single dose 40 IU/Kg at the same time as the first dose of vaccine. ERIG will be infiltrated around and into all wounds as recommended by WHO for patients in group IV and injected intramuscular at each of both gluteal areas for participants in group III,V,VI"
16233263|NCT01137032|Drug|Pandel Cream 0.1%|A thin coat of cream will be applied and rubbed into the affected areas, as well as normal skin, twice daily for 21 days
16233264|NCT01137019|Device|Biolimus-eluting stent|The biolimus-eluting coronary stent contains a stainless steel platform on which an abluminally coated polylactic acid (PLA) biodegradable polymer is placed that eludes biolimus-A9.
16233265|NCT01137019|Device|Everolimus-eluting coronary stent|The everolimus-eluting coronary stent is a cobalt chromium platform stent with a permanent fluorinated copolymer matrix that eludes everolimus
16233266|NCT01137006|Biological|IMC-20D7S (Cohort 1A)|"5 mg/kg i.v. every 2 weeks.
~Administered every other week on Days 1 and 15 of each treatment cycle.
~If no dose-limiting toxicity (DLT) in first 3 participants or 1 DLT in 6 participants, then enrollment into Cohort 2A."
16233267|NCT01137006|Biological|IMC-20D7S (Cohort 2A)|"10 mg/kg i.v. every 2 weeks.
~Administered every other week on Days 1 and 15 of each treatment cycle.
~If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 2A, then enrollment into Cohort 3A."
16233268|NCT01137006|Biological|IMC-20D7S (Cohort 3A)|"20 mg/kg i.v. every 2 weeks.
~Administered every other week on Days 1 and 15 of each treatment cycle.
~If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 3A, then enrollment into Cohort 4A."
16233269|NCT01137006|Biological|IMC-20D7S (Cohort 4A)|"30 mg/kg i.v. every 2 weeks.
~Administered every other week on Days 1 and 15 of each treatment cycle."
16233270|NCT01137006|Biological|IMC-20D7S (Cohort 1B)|"10 mg/kg i.v. every 3 weeks.
~Administered every 3 weeks on Days 1 and 22 of each treatment cycle.
~If no dose-limiting toxicity (DLT) in first 3 participants or 1 DLT in 6 participants in Cohort 1B, then enrollment into Cohort 2B."
16233271|NCT01137006|Biological|IMC-20D7S (Cohort 2B)|"20 mg/kg i.v. every 3 weeks.
~Administered every 3 weeks on Days 1 and 22 of each treatment cycle.
~If no DLT in first 3 participants or 1 DLT in 6 participants in Cohort 2B, then enrollment into Cohort 3B."
16233272|NCT01137006|Biological|IMC-20D7S (Cohort 3B)|"30 mg/kg i.v. every 3 weeks.
~Administered every 3 weeks on Days 1 and 22 of each treatment cycle."
16233273|NCT01136980|Device|TIF Transoral Fundoplication|A novel surgical technique that creates a gastric fundoplication and restores competency of the gastroesophageal valve now exists for patients who have limited anatomic defects (small hiatal hernia). This technique is performed transorally using the EsophyX device (EndoGastric Solutions, Inc. Redmond, WA, USA) recreates a gastric fundoplication at the gastroesophageal junction by creating a flap valve at the intersection of the stomach and the esophagus by deploying polypropylene SerosaFuse fasteners (EndoGastric Solutions)
16233275|NCT01136967|Drug|Lenvatinib|Participants received lenvatinib 24 mg orally, once daily continuously in 28-day cycles until disease progression, development of unacceptable toxicity or withdrawal of consent.
16233276|NCT01136954|Drug|Zonisamide|Transition Period from Study E2090-E044-312: Placebo Open-Label Period: 1 to 8 mg/kg orally per day for approximately 59 weeks.
16233277|NCT01136941|Drug|Zileuton|Zileuton is available as a 600 mg tablet. Dosing begins at 2.4gm/day and will be increased to 3.0gm/day. Tablets will be taken twice daily for the 6 week duration of the study.
16233278|NCT01136928|Drug|American ginseng|Healthy volunteers will ge given efavirnez 600 mg daily monotherapy for 14 days followed by efavirenz 600 mg PLUS American ginseng 3000 mg daily for an additional 14 days.
16233279|NCT01136915|Drug|Iopamidol 370|one time administration for PCI
16233280|NCT01136915|Drug|Iodixanol 320|Iodixanol 320 single injection for percutaneous coronary injection
16233281|NCT01136902|Dietary Supplement|Oral Glucose Tolerance Test (OGTT)|75 g of glucose dissolved in 250 mL water.
16233282|NCT01136889|Other|PFMT|Women who have been successfully fitted with a vaginal pessary will be asked to attend five outpatient appointments over a 16 week period with a trained specialist women's health physiotherapist.
16233283|NCT01136876|Drug|Iopamidol|Iopamidol 370, one time administration for percutaneous coronary intervention
16233284|NCT01136876|Drug|Iodixanol-320|Iodixanol-320 single administration for percutaneous coronary intervention procedure
16233285|NCT01136863|Drug|Felodipine|
16233286|NCT01136863|Drug|Placebo|
16233287|NCT01136850|Drug|chloroquine, sulphadoxine pyrimethamine, LLIN|"> 50Kg: chloroquine base 150 mg 4 tablets daily for 3 days, plus sulphadoxine pyrimethamine 1500/75 mg single dose.
~< 50 Kg: chloroquine base 150 mg 3 tablets daily for 3 days, plus sulphadoxine pyrimethamine 1500/75 mg single dose.
~Given at enrolment, 14-26 weeks gestation, by mouth."
16233288|NCT01136850|Drug|azithromycin, sulphadoxine pyrimethamine, LLIN|"sulphadoxine pyrimethamine (1500 mg/75 mg as single dose) plus azithromycin (1 g twice daily for 2 days).
~Given three times by mouth at monthly intervals, commencing at between 14 and 26 weeks gestation."
16233289|NCT01136837|Other|primary pcı|
16233290|NCT01136824|Other|Questionnaires|"Subjects will be given a series of questionnaires to assess the effect of AI chemotherapy, and the possible role of tumor load, on the amount of symptoms. The extent of nausea, vomiting, fatigue, anxiety, sleep disturbance, and cognitive changes will be measured. In adjuvant chemotherapy patients, we will also assess the relationship between tumor size and amount of chemotherapy-induced symptoms. These questionnaires will involve the following assessments:
~Demographic & health Trait anxiety Quality of life Nausea Expectations Anxiety & total mood disturbance Nausea & vomiting Multiple symptoms"
16233291|NCT01136811|Device|Computer assisted surgery|"use of computer assisted surgical device in vascular surgery
~completion of the proximal (femoral) anastomosis portion of a lower extremity bypass procedure"
16233292|NCT01136798|Drug|Exenatide|Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks
16233293|NCT01136798|Drug|Placebo|Exenatide or placebo medication administered subcutaneously 5 mcg twice daily for 2 weeks, followed by 10 mcg twice daily for 4 weeks
16233294|NCT01136785|Device|active CPAP Therapy|7 days of active CPAP therapy
16233295|NCT01136785|Device|sham CPAP therapy|7 days of sham CPAP therapy
16233296|NCT01136772|Drug|haloperidol decanoate|haloperidol decanoate injections, 25-200 mg once a month
16233297|NCT01136772|Drug|paliperidone palmitate|Paliperidone palmitate injections, 39 mg - 234 mg once a month
16233300|NCT01136746|Drug|Human regular insulin|Administered subcutaneously, four times daily, according to sliding scale insulin algorithm throughout hospital study period (1 to 10 days post-randomization)
16233301|NCT01136746|Drug|Insulin lispro|Administered subcutaneously, 3 to 4 times daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)
16233302|NCT01136746|Drug|Insulin glargine|Administered subcutaneously, once daily, according to plasma glucose levels throughout hospital study period (1 to 10 days post-randomization)
16233303|NCT01136733|Drug|Lenvatinib|taken orally, once a day
16233304|NCT01136733|Drug|Everolimus|taken orally, once a day
16233305|NCT01136668|Procedure|Transversus Abdominis Plane Block|A high frequency (5-10 mHz) ultrasound probe (Sonosite Micromaxx, Licence No 12407) will be placed on the flank at the midpoint between the iliac crest and lower costal margin. The three muscle layers of external oblique, internal oblique, and transversus abdominis will be visualized. A 22G short-bevel block needle will be advanced in an anterior-to-posterior direction, in-plane with the probe, until the tip is visualized in the transversus abdominis plane. After negative aspiration, 0.4 ml/kg of bupivacaine 0.25% with 1:200,000 epinephrine will be injected. The total dose of bupivacaine will not exceed 2 mg/kg and the total volume will not be more than 20 ml.
16233306|NCT01136668|Procedure|Standard|Circumferential subcutaneous infiltration of the ostomy wound with bupivacaine 0.25% with 1:200 000 epinephrine 0.4 ml/kg by the surgeon after skin closure.
16233307|NCT01136655|Drug|80/2.25 μg Symbicort pMDI|inhalation
16233308|NCT01136655|Drug|80/4.5 μg Symbicort pMDI|inhalation
16233309|NCT01136655|Drug|Foradil Aerolizer 12 μg|inhalation
16233310|NCT01136655|Drug|40 μg budesonide HFA pMDI|inhalation
16233311|NCT01136655|Drug|placebo HFA pMDI|inhalation
16233312|NCT01136642|Drug|Nicotrol|
16233313|NCT01136603|Device|TIGR Mesh|TIGR mesh as a reconstruction material for the repair of the abdominal wall post Lipectomy, TRAM / DIEP flap.
16233314|NCT01136590|Drug|Tranexamic Acid|A 10-mg/kg dose of tranexamic acid will be administered as a bolus or as a fast, 20-minute intravenous infusion before performing the incision at the start of surgery, followed by perfusion of 2 mg/kg/hour up to the time the surgical wound is closed at completion of surgery.
16233315|NCT01136590|Drug|fisiologic serum|The placebo will be administered according to the same regimen and infusion time as the medication in the study arm (bolus or 20-minute fast infusion before the incision at the beginning of surgery followed by perfusion of 2 mg/kg/hour until closure of the surgical wound at completion of surgery)
16233316|NCT01136577|Device|Phototherapy|Phototherapy devices of ramp type placed over the incubator to treat with light in the 420-490nm range one face of the naked baby suffering jaundice.
16233317|NCT01136564|Drug|Zemplar|2 capsules of 1 microgram daily
16233319|NCT01136551|Drug|Huperzine A|Each volunteer will receive single dose of three different formulations of Huperzine A. One immediate release formulation of 0.4mg and two different controlled release formulations at same dose. Between the study phases will be a washout period of at least 21 days.
16233320|NCT01136538|Drug|Valacyclovir Hydrochloride|Valacyclovir Hydrochloride Tablets, 1000 mg of Dr. Reddy's Laboratories Limited
16233321|NCT01136525|Drug|Valacyclovir Hydrochloride|Valacyclovir Hydrochloride Tablets, 1000 mg of Dr. Reddy's Laboratories Limited
16233322|NCT01136499|Drug|LBH589 (Panobinostat®)|"40 mg MWF.
~40 mg of LBH589, orally administered on Monday, Wednesday and Friday (MWF) on a weekly schedule, until tumor progression or unacceptable toxicity."
16233323|NCT01136447|Procedure|Ultrasound|Block catheter will be introduced using ultraosound
16233324|NCT01136421|Drug|Ipratropium bromide|Patients received ipratropium bromide (IB group, 0.5 mg in 3 mL of normal saline) delivered via aerosol mask at 10 L/min driven by pressurised air. Simultaneously, patients received intravenous placebo (10 mL of normal saline). Thereafter 4 doses of nebulised IB with terbutaline are administered at 30 min intervals.
16233325|NCT01136421|Drug|Magnesium Sulfate|Patients received magnesium sulfate (MgSO4 group, 150 mg in 4 mL of normal saline)delivered via aerosol mask at 10 L/min driven by pressurised air. Simultaneously, additional magnesium sulfate is given as an intravenous bolus (1.5g in 10 ml). Patients received thereafter 4 doses of nebulized magnesium sulfate with terbutaline at 30 min intervals.
16233326|NCT01136408|Drug|Dabigatran etexilate|Dabigatran etexilate 110 mg capsule, twice a day, oral administration
16233327|NCT01136408|Drug|Dabigatran etexilate|Dabigatran etexilate 150 mg capsule, twice a day, oral administration
16233328|NCT01136408|Drug|Warfarin|Dose-adjusted warfarin based on target INR values
16233329|NCT01136395|Drug|Rituximab|375mg/m2 4 weeks before ABOi LD transplantation
16233330|NCT01136395|Procedure|living donor transplantation|living donor transplantation (ABO compatible) to be compared with deceased donor transplantation (ABO compatible) in its impact on immunological parameters of graft outcome and on viral replication (CMV, EBV, BK/JC), respectively
16233331|NCT01136395|Procedure|deceased donor transplantation|deceased donor transplantation (ABO compatible) to be compared with living donor transplantation (ABO compatible) in its impact on immunological parameters of graft outcome and on viral replication (CMV, EBV, BK virus (BKV), JC virus (JCV)), respectively
16233332|NCT01136382|Drug|budesonide|pMDI, inhalation, bid, 6 weeks
16233333|NCT01136382|Drug|placebo|pMDI, inhalation, bid, 6 weeks
16233334|NCT01136369|Device|OSNA Breast Cancer System|"For in vitro diagnostic use only.
~The OSNA Breast Cancer System is an automated semi-quantitative, in vitro diagnostic test for the rapid detection of greater than (>) 0.2 mm metastases in nodal tissue removed from sentinel lymph node biopsies of breast cancer patients. Results from the assay can be used to guide the intra-operative or post-operative decision to remove additional lymph nodes and to aid in patient staging. An assay positive + or ++ result indicates the presence of metastasis (> 0.2 mm). An assay positive ++ result predicts the presence of macrometastasis (> 2 mm).
~Post-operative histological evaluation of permanent sections of the tissue specimen, in accordance with usual diagnostic practice and using the Sysmex lymph node cutting scheme, is required."
16233335|NCT01136356|Drug|buprenorphine|parenteral buprenorphine may be administered at multiple times each day
16233336|NCT01136356|Drug|morphine|parenteral morphine may be administered multiple times each day
16233337|NCT01136343|Other|lifestyle modified project|education, counseling
16233338|NCT01136317|Drug|Omeprazole|
16233339|NCT01136317|Drug|Rabeprazole|
16233340|NCT01136317|Drug|Lactose|
16233341|NCT01136304|Drug|Imiglucerase|Imiglucerase intravenous infusions regardless of dose or schedule of administration.
16233342|NCT01136291|Other|physical exercise|"The exercise protocol was done under supervision once a week. Pregnant women have been told to do some exercise three more times during the week unsupervised and may be the protocol of exercises or walk in mild to moderate intensity.
~The exercise protocol lasted 50 minutes with 10 minutes of stretching overall, 30 minutes of exercise for muscle strengthening and 10 minutes of relaxation.
~These women also received nutrition counseling and prenatal care."
16233343|NCT01136278|Drug|3,4-Methylenedioxymethamphetamine|125 mg, single dose
16233344|NCT01136278|Drug|Clonidine|150 μg per os
16233345|NCT01136278|Drug|placebo|capsules identical to MDMA or clonidine
16233346|NCT01136252|Drug|Adalimumab|Intravitreal adalimumab injection (0,1 ml= 50 mcg) in the eye of the included patients. Patients will be followed up every week for a total of 4 weeks, and after every month until 6 months. If it is necessary, repeat the injection every month, maximum three months
16233347|NCT01136239|Drug|N-acetycysteine (600mg twice daily)|N-acetycysteine (600mg twice daily) for one year
16233348|NCT01136239|Drug|Placebo|Placebo (600mg twice daily)
16233349|NCT01136226|Drug|Eligard (TM)|Eligard (TM) 22.5 mg administered at baseline and Month 3
16233350|NCT01136213|Radiation|PET (Positron Emission Tomography) Study|5-HT1a auto-receptors will be visualized in vivo using 18F-MPPF PET study. Two PET studies will be performed, one after the intake of a single oral dose of fluoxetine and the other after placebo. The order of fluoxetine and placebo intake will be randomly assigned.
16233351|NCT01136213|Other|Brain MRI (magnetic resonance imaging)|A brain MRI (magnetic resonance imaging)will be performed the day of the first PET study.
16233352|NCT01136213|Drug|Fluoxétine / Placebo|The two PET studies will be performed, one after the intake of a single oral dose of fluoxetine and the other after placebo. The order of fluoxetine and placebo intake will be randomly assigned.
16233353|NCT01136200|Other|Infectious disease specialist advice|Indication, choice, dosing and duration of antimicrobial therapy
16233354|NCT01136187|Procedure|Access site in primary PCI|
16233355|NCT01136174|Drug|Placebo|Placebo BID for cohort 1,2,3
16233356|NCT01136174|Drug|BIBF 1120|50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively
16233357|NCT01136174|Drug|BIBF 1120|50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively
16233358|NCT01136174|Drug|BIBF 1120|50 mg, 100 mg, 150 mg BID will be used for Cohort 1, 2, and 3 respectively
16233359|NCT01136161|Biological|RUTI|dose:5 micrograms of FCMtb (Fragmented cells of M. tuberculosis); given subcutaneously twice, on days 28 and 56.
16233886|NCT01132313|Drug|BI 201335|28 weeks, QD
16233360|NCT01136161|Biological|RUTI|dose:25 micrograms of FCMtb (Fragmented cells of M. tuberculosis); given subcutaneously twice, on days 28 and 56.
16233361|NCT01136161|Biological|RUTI|dose:50 micrograms of FCMtb (Fragmented cells of M. tuberculosis); given subcutaneously twice, on days 28 and 56.
16233362|NCT01136161|Biological|RUTI Matching Placebo|Placebo of the vaccine RUTI; given subcutaneously twice, on days 28 and 56.
16233363|NCT01136148|Behavioral|A medical and mental health unit|A specialist medical and mental health unit with both physician and psychiatric medical and nursing staff, and mental health experienced therapists. Emphasis will be on early and accurate diagnosis, multidisciplinary management, rigorous communication and goal setting, discharge planning and interface with community services.
16233364|NCT01136135|Other|CARDIAC MRI|To find a non-invasive alternative (with using cardiac MRI) to invasive endomyocardial biopsies for serial detection and follow-up of cellular rejection in heart transplant in childhood.
16233365|NCT01136122|Device|CPAP Treatment|Effective CPAP treatment for one month
16233366|NCT01136096|Behavioral|Physical activity promoting intervention|"An interview with a physiotherapist
~An exercise video specially designed by this study including warm-up, aerobic, cool-down and stretching exercises, and/or a simple exerciser to use at home
~An individualized home-based exercise program based on the Health Belief Model and Transtheoretical Model
~The daily record to check their body weight, exercise mode and duration
~Proper diet, caloric intake calculation, metabolic risk factors and prevention of diabetes were taught and a guide book was provided that included all the above mentioned details
~Telephone reminders of healthy lifestyle including the ways of overcoming barriers of regular exercise every 1 to 2 weeks for 3 months, 1-2 calls a month afterwards and no calls for the last month on a tapered off schedule"
16233367|NCT01136096|Behavioral|General instruction and education|"Oral instruction and written general education information about weight control, proper diet and regular exercise in a one-page education brochure that was similar to the way used in the outpatient clinic
~Telephone reminders of healthy lifestyle every 1 to 2 weeks for 3 months, 1-2 calls a month afterwards and no calls for the last month on a tapered off schedule
~Without individualized exercise program and interview with a physiotherapist"
16233368|NCT01136083|Behavioral|Exercise training|Subjects in exercise group will undergo individualized high aerobic interval training on treadmill for 30 minutes under the supervision of an experienced physical therapist 3 times a week and home exercise twice a week with accelerometer.
16233369|NCT01136083|Other|Usual care|Subjects in control group will not undergo individualized high aerobic interval training on treadmill. They will receive usual care as normally does in hospital.
16233370|NCT01136057|Biological|Collection of Anti-Influenza A Immune Plasma|
16233371|NCT01136044|Other|septocutaneous perforator flap|Perforator flaps can be based on septocutaneous or musculocutaneous perforators. If septocutaneous perforators are present, the harvest of these flaps is more straight forward and the dissection of the pedicle is easy.
16233372|NCT01136031|Drug|Paclitaxel and irinotecan|"In phase I part, Level Paclitaxel (mg/m²) Irinotecan (mg/m²)
~100 100
~100 120
~135 120
~135 160
~every 3 week"
16233373|NCT01136018|Procedure|insertion needle via intentionally lateral direction.|evaluation of iodinated contrast flow patterns in caudal epidurography with intentional lateral caudal approach
16233374|NCT01136005|Other|dexpanthenol 5% cream|Apply at least two times a day on face, chest and upper arms during the 6 week treatment period
16233375|NCT01136005|Other|Cetomacrogol cream|Apply at least two times a day on face, chest and upper arms during the 6 week treatment period
16233376|NCT01135992|Drug|insulin degludec|Individually adjusted insulin degludec administered three times weekly with continued unchanged pre-trial OAD (oral anti-diabetic drug) treatment for 12 weeks
16233377|NCT01135992|Drug|insulin glargine|Subjects continue their pre-trial insulin glargine once daily plus OAD (oral anti-diabetic drug) treatment for four weeks before switch to insulin degludec
16233378|NCT01135966|Behavioral|Conventional resistance training program|Conventional resistance training program is followed.
16233379|NCT01135966|Behavioral|Whole body vibration resistance training program|WBV training on FITVIBE
16233380|NCT01135953|Device|Transcranial Direct Current Stimulation (tDCS)|tDCS applied to to motor cortex every weekday (5 sessions), at 2mA ,during 20 minutes.Conductive rubber electrodes (7 x 5 cm = 35 cm2) covered by sponges soaked in saline will be used, held in place by a band. The current will be gradually increased to the level of 2 mA over 30 seconds (to avoid the sensation of a flash).
16233381|NCT01135953|Device|Transcranial Direct Current Stimulation (tDCS)|tDCS applied to the motor cortex every day of the week during 20 minutes, at 1mA first session, 1.5 mA second and third sessions, and 2mA fourth and fifth sessions, during 20 minutes. Conductive rubber electrodes (7 x 5 cm = 35 cm2) covered by sponges soaked in saline will be used, held in place by a band. The current will be gradually increased over 30 seconds (to avoid the sensation of a flash).
16233382|NCT01135953|Other|Transcranial direct Stimulation (tDCS) and D-cycloserine|"Transcranial Direct Stimulation applied to the motor cortex every day of the week (5 sessions) at 2mA, during 20 minutes. Conductive rubber electrodes (7 x 5 cm = 35 cm2) covered by sponges soaked in saline will be used, held in place by a band. The current will be gradually increased to the level of 2 mA over 30 seconds (to avoid the sensation of a flash).
~D-cycloserine, administered orally (capsules), 100 mg, twice a week (Monday and Thursday), prior to the tDCS session."
16233383|NCT01135940|Device|2-octylcyanoacrylate (Dermabond) closure|Standard procedure for closure of adipose/ subcutaneous layers. The subcuticular layer will be closed with a continuous 2-0 vicryl suture which will then be followed by Dermabond closure.
16233384|NCT01135940|Device|Standard staple closure|Standard procedure for closure of adipose/ subcutaneous layers followed by staple closure
16233385|NCT01135927|Drug|insulin degludec|NN1250 (insulin degludec) injected s.c. (under the skin) once daily for 6 days
16233386|NCT01135927|Drug|insulin detemir|Insulin detemir injected s.c. (under the skin) once daily for 6 days
16233387|NCT01135914|Drug|ranibizumab|Ranibizumab 0.5 mg fixed loading dose via intravitreal injection, given once per month for 3 consecutive months (Day 1, Month 1 and Month 2). This treatment could be reapllied, depending on symptoms.
16233388|NCT01135914|Procedure|Laser|Laser photocoagulation treatment was administered on Day 1. Subsequent laser treatments could be administered if needed, in accordance with Early Treatment Diabetic Retinopathy Study (ETDRS) guidelines.
16233433|NCT01135524|Drug|Buprenorphine transdermal patch|Buprenorphine transdermal patch 5 mcg/h applied transdermally for 7-day wear.
16233389|NCT01135901|Behavioral|Behavioural change programme|The programme consists of a introductory course, organised physical activity 2-3 times a week, meetings every 3rd month with lectures and theme nights, and organising self-help groups.
16233390|NCT01135888|Device|Skin cooling devices|Cooling vest and cooling bandana
16233391|NCT01135875|Other|GBM Patients|2 teaspoons of blood will be collected during select clinic visits.
16233392|NCT01135875|Other|Normal Controls|2 teaspoons of blood will be collected once.
16233393|NCT01135862|Drug|platelets|6 packs of platelets will be administered
16233394|NCT01135836|Procedure|Pulmonary recruitment maneuver|a pulmonary recruitment maneuver consisting of five manual pulmonary inflations was performed with a maximum pressure of 60 cm H2O. The anestheiologist held the fifth positive pressure inflation for approximately 5 seconds.
16233395|NCT01135836|Procedure|Intraperitoneal normal saline|the upper part of the abdominal cavity was evenly and bilaterally filled with the 0.9% normal saline in the amount of 500 cc. We will leave the fluid in the abdominal cavity.
16233396|NCT01135836|Procedure|Control group|CO2 was removed by passive exsufflation through the port site.
16233397|NCT01135823|Procedure|Patient survey|
16233398|NCT01135810|Behavioral|Hypnosis|
16233399|NCT01135810|Behavioral|Meditation|
16233400|NCT01135784|Dietary Supplement|MIGRA-ZEN RELIEF PLUS|one 2-capsule dose per 24hrs for a total of 180 caps over 90 days
16233401|NCT01135784|Dietary Supplement|Placebo for Migrazen relief plus|2 capsule dose per 24 hours for 90 days
16233402|NCT01135771|Other|glucose and insulin IV to alter blood glucose|
16233403|NCT01135758|Drug|Ketamine|Administration of a subanaesthetic dose of Ketamine, intravenously (0.5 mg/kg)
16233404|NCT01135745|Device|Reclaim® Deep Brain Stimulation|Implant of leads in pre-defined brain area; implant of neurostimulators
16233405|NCT01135732|Procedure|brush cytology|brush cytology during ERCP
16233406|NCT01135719|Procedure|LASIK and PRK|Wavefront-guided versus wavefront-optimized LASIK or PRK.
16233407|NCT01135706|Other|No Intervention|This study does not include an intervention but is observational in nature.
16233408|NCT01135680|Drug|HPN-100|single oral dose of 9 mL HPN-100 given via syringes 3 times daily for 3 days
16233409|NCT01135680|Drug|HPN-100 or Placebo|single oral dose of 12 mL HPN-100 given via syringes 3 times daily for 3 days
16233410|NCT01135680|Drug|Placebo|single oral (by mouth) dose of 9 mL placebo given via syringes 3 times daily for 3 days
16233411|NCT01135680|Drug|Moxifloxacin|single oral 400-mg dose on study Day 3
16233412|NCT01135680|Drug|HPN-100|single oral dose of 6 mL HPN-100 and 3 mL placebo given via syringes 3 times daily for 3 days
16233413|NCT01135680|Drug|HPN-100|single oral dose of 9 mL HPN-100 given via syringes 3 times daily for 3 days
16233414|NCT01135667|Drug|clopidogrel|clopidogrel 150 mg once daily for 30 days
16233415|NCT01135667|Drug|Prasugrel 10 mg|Prasugrel 10 mg once daily for 30 days
16233416|NCT01135654|Other|Training & Tech Support for Delivery of Alcohol Screening, Brief Intervention, and Referral To Treatment|"We provide training and technical support for providers to conduct Alcohol Screening, Brief Intervention, and Referral to Treatment. The training is based on the NIAAA clinician's guide to Helping Patients Who Drink Too Much."
16233417|NCT01135641|Drug|Rituximab|Patients will receive in addition to ciclosporine A and corticosteroids (prednisone) 1 mg/kg/day, Rituximab at 375 mg/m²/infusion once a week for 4 consecutive weeks.
16233418|NCT01135641|Drug|Ciclosporine|
16233419|NCT01135641|Drug|Corticosteroids|
16233420|NCT01135628|Other|Auxiliary Treatment|Lactobacillus reuteri, 1 tablet bid, each of 100,000,000 FCU for 6 months
16233421|NCT01135628|Dietary Supplement|Hyperproteic and fiber-rich diet|Hyperproteic diet consisting in 1.5 gr/kg of protein per day Fiber-rich diet
16233422|NCT01135628|Drug|Nitazoxanide|Nitazoxanide tablets 400 mg, bid, orally for 6 months
16233423|NCT01135615|Drug|Sevelamer|The starting dose for sevelamer was 1-2 capsules (800 mg) three times a day
16233424|NCT01135615|Drug|calcium acetate|calcium acetate (1000 mg) 1 tablet three times a day
16233425|NCT01135602|Drug|Topiramate|Topiramate 50-300 mg/day Orally Twice per day
16233426|NCT01135589|Drug|Micafungin|i.v.
16233427|NCT01135576|Dietary Supplement|non-fortified fruit juices consumed as part of the usual diet|
16233428|NCT01135576|Dietary Supplement|Iron fortified fruit juice|Consumption of micronized iron pyrophosphate supplemented fruit juices as part of the usual diet
16233429|NCT01135563|Drug|Vinblastine and Sirolimus|"Patients will be enrolled to receive vinblastine and sirolimus in 28 day cycles. Using the 3+3 standard Phase1 design, vinblastine will be administered via IV push on Days 1, 8, 15, 22. The starting dose of 4 mg/m2 (Dose Level 1) is 67% of the established MTD (6 mg/m2) for this schedule in pediatrics. Dose escalation will take place in a standard 3+3 design, in which doses will increase by approximately 20 to 25% in successive 3-patient cohorts.
~Sirolimus (rapamycin) will be given by mouth (tablet or suspension) once daily throughout the cycle. Ideally patients will remain on the same dose form (tablet or suspension) for the duration of the study. All patients will be assigned a target sirolimus serum trough"
16233430|NCT01135550|Drug|High dose dexamethasone|"Subject will receive 5 mg/m2 po divided in two doses. Dexamethasone 4mg/mL solution will be compounded into a 1mg/mL dosage form.
~If symptoms are well controlled over 2 weeks time, tapering of dexamethasone can be considered. It will be at the treating physician's discretion to decide the start of the tapering of dexamethasone. The weaning schedule will be the same in both intervention arms: halving the dose once weekly (week 1, week 2) while continuing to give two doses/day, one half morning dose at week 3 and every second day at week 4."
16233431|NCT01135550|Drug|Low dose dexamethasone|"Subject will receive 1 mg/m2 po divided in two doses. Dexamethasone 4mg/mL solution will be compounded into a 1mg/mL dosage form.
~If symptoms are well controlled over 2 weeks time, tapering of dexamethasone can be considered. It will be at the treating physician's discretion to decide the start of the tapering of dexamethasone. The weaning schedule will be the same in both intervention arms: halving the dose once weekly (week 1, week 2) while continuing to give two doses/day, one half morning dose at week 3 and every second day at week 4."
16233432|NCT01135537|Biological|Thymoglobulin (rATG)|"Thymoglobulin 2.5 mg/kg of body weight IV administered daily for 3 days prior to HSCT.
~Thymoglobulin infused over a minimum of 6 hours for the first infusion and over at least 4 to 6 hours on subsequent days of therapy."
16233434|NCT01135524|Drug|Buprenorphine transdermal patch|Buprenorphine transdermal patch 10 mcg/h applied transdermally for 7-day wear.
16233435|NCT01135524|Drug|Buprenorphine transdermal patch|Buprenorphine transdermal patch 20 mcg/h applied transdermally for 7-day wear.
16233436|NCT01135511|Drug|CP-690,550 Eye drops|Ophthalmic topical solution, low dose, dosed once/day, 8 weeks
16233437|NCT01135511|Drug|CP-690,550 Eye drops|Ophthalmic topical solution, medium dose, dosed once/day, 8 weeks
16233438|NCT01135511|Drug|CP-690,550 Eye drops|Ophthalmic topical solution, high dose, dosed once/day, 8 weeks
16233439|NCT01135511|Drug|CP-690,550 Eye drops-vehicle|Ophthalmic topical solution, vehicle, dosed once/day, 8 weeks
16233440|NCT01135511|Drug|Sodium Hyaluronate|Ophthalmic topical solution, dosed 6 times/day, 8 weeks
16233441|NCT01135498|Drug|bevacizumab [Avastin]|Intravenous repeating dose
16233442|NCT01135498|Drug|eloxatin|Intravenous repeating dose
16233443|NCT01135498|Drug|capecitabine [Xeloda]|Oral repeating dose
16233444|NCT01135498|Drug|erlotinib [Tarceva]|Oral repeating dose
16233445|NCT01135472|Drug|Esomeprazole Magnesium|NEXIUM 40MG ONCE DAILY FOR 7 DAYS WITH A 2 WEEK WASHOUT PERIOD, NEXIUM 40MG TWICE DAILY WITH A 2 WEEK WASHOUT PERIOD, NEXIUM 80MG TWICE DAILY WITH A 2 WEEK WASHOUT PERIOD.
16233446|NCT01135459|Drug|Lupuzor|200 mcg.
16233447|NCT01135459|Drug|Placebo|Matching placebo was administered subcutaneously every 4 weeks for 20 weeks for a maximum of 6 doses.
16233448|NCT01135446|Drug|dapagliflozin|Oral Solution, Oral, 0.001 mg, once on Day 1 only, 2 days
16233449|NCT01135446|Drug|dapagliflozin|Oral Solution, Oral, 0.01 mg, once on Day 1 only, 2 days
16233450|NCT01135446|Drug|dapagliflozin|Oral Solution, Oral, 0.1 mg, once on Day 1 only, 2 days
16233451|NCT01135446|Drug|dapagliflozin|Tablets, Oral, 0.3 mg, once on Day 1 only, 2 days
16233452|NCT01135446|Drug|dapagliflozin|Tablets, Oral, 1 mg, once on Day 1 only, 2 days
16233453|NCT01135446|Drug|dapagliflozin|Tablets, Oral, 2.5 mg, once on Day 1 only, 2 days
16233454|NCT01135433|Drug|ipragliflozin|oral
16233455|NCT01135433|Drug|Placebo|oral
16233456|NCT01135433|Drug|metformin|oral
16233457|NCT01135420|Behavioral|Telephone Monitoring (TM) with Motivational Interviewing|Patients in the TM condition will receive an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge. The TM intervention will have a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse. The purpose of the intervention condition is to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety.
16233458|NCT01135420|Other|Usual care|All patients in the trial will receive usual care (i.e., the care they would have received in the absence of a study).
16233459|NCT01135407|Other|Recording during computerized tests|"Patients will perform more than one experimental session. In each experimental session 3 computerized tasks, which are suitable to study visual attention, decision making and motor performances will be presented. During these tests, participants have to responds the most quickly and accurately possible to the appearance on a computer display of a predetermined target stimuli, presented alone or in an array of signals.
~The computerized tests are administered in two different conditions of medication: with or without dopaminergic treatment, corresponding to two different experimental sessions."
16233460|NCT01135407|Other|Recording during computerized tests|Patients will perform more than one experimental session. In each experimental session 3 computerized tasks, which are suitable to study visual attention, decision making and motor performances will be presented. During these tests, participants have to responds the most quickly and accurately possible to the appearance on a computer display of a predetermined target stimuli, presented alone or in an array of signals. The computerized tests are administered in three different sets of electrical (without stimulation, or selective stimulation of the sensorimotor or associative/limbic part of the subthalamic nucleus) stimulation, corresponding to three different experimental sessions.
16233461|NCT01135407|Other|Recording during computerized tests|Participants will perform more than one experimental session. In each experimental session 3 computerized tasks, which are suitable to study visual attention, decision making and motor performances will be presented. During these tests, participants have to responds the most quickly and accurately possible to the appearance on a computer display of a predetermined target stimuli, presented alone or in an array of signals.The computerized tests are administered twice (in two different experimental sessions) to verify the performance repeatability.
16233462|NCT01135394|Drug|Pioglitazone|30 mg tablet once daily for 4 weeks, then increased to 45 mg once daily for an additional 8 weeks. Total dosage period is 12 weeks.
16233463|NCT01135381|Behavioral|IVR-Enhanced Care|Those randomized to e-Coach will receive initial coaching in the hospital and then will be called by the interactive voice response-supported (IVR) system at specified intervals after discharge for monitoring. Any red flags noted through the IVR monitoring system will be transmitted to the care transition coaches, who contact patients and coach them on how to address problems identified.
16233464|NCT01135368|Drug|Lansoprazole|Lansoprazole capsules
16233465|NCT01135342|Behavioral|Diet and exercise|Standardized instruction to eat less and exercise more to create an energy balance deficit to promote weight loss (16 classes)
16233466|NCT01135342|Behavioral|Cognitive Behavioral Therapy|Standardized cognitive behavioral therapy for insomnia (8 classes)
16233467|NCT01135342|Behavioral|Passion and Balance|Attention-match sessions of general interest, but unrelated to diet, exercise, or sleep (8 sessions)
16233468|NCT01135329|Drug|Fludarabine|30 mg/m^2 IV daily on Day -6 through Day -2.
16233469|NCT01135329|Drug|Busulfan|1 mg/kg PO OR 0.8 mg/kg IV four times daily on Day -6 through Day -3.
16233470|NCT01135329|Drug|Cyclophosphamide|50 mg/kg IV daily on Day +3 and Day +4.
16233471|NCT01135329|Drug|Mycophenolate Mofetil|15 mg/kg PO three times daily (max daily dose of 3g) starting on Day +5.
16233472|NCT01135329|Drug|Tacrolimus|Dosed based on drug levels; begin on Day +5 at 1 mg IV daily.
16233473|NCT01135316|Drug|Ablavar|One dose of Ablavar will be administered for use during a contrast MRI examination
16233474|NCT01135303|Device|VistaO2 device|Full night VistaO2 device monitoring synchronized with the gold standard polysomnography.
16233475|NCT01135290|Drug|Aquaphor|
16233476|NCT01135290|Drug|HP828-101|
16233477|NCT01135264|Behavioral|CBT|The CBT treatment developed by Ladouceur (Consultant) will serve as control condition (outline of published treatment manual by Ladouceur & Lachance, 2006. This treatment served as a model for the cognitive-behavioral component in CMBT and has received empirical support in two studies from Ladouceur's lab (Sylvain et al., 1997; Ladouceur et al., 2004). It places strong emphasis on cognitive correction of erroneous beliefs about gambling and also focuses on coping skills training and relapse prevention. CBT also lasts 12 weekly sessions.
16233478|NCT01135264|Behavioral|CMBT|We used the NIMH-funded R21 mechanism to develop and test the CMBT intervention (Wulfert et al., 2003, 2005; 2006). Treatment will be implemented in 12 weekly sessions (3 motivational enhancement sessions, 8 sessions of cognitive-behavioral treatment, 1 session of relapse prevention)
16233479|NCT01135251|Drug|dimiracetam|400 mg capsules for oral use to be administered twice a day for a total of 8 weeks
16233480|NCT01135251|Drug|sugar pill|capsules containing 400 mg of inert material will be orally administered twice a day, one pill for 2 weeks, 2 pills for other 2 weeks and 4 pills for the last 4 weeks.
16233481|NCT01135225|Device|PROMUS(TM) Element (TM) Stent System|The PROMUS Element Everolimus-Eluting Coronary Stent System is a device/drug combination product composed of two components: a device (coronary stent system) and a drug product (a formulation of everolimus contained in a polymer coating.
16233482|NCT01135225|Device|Evolution Stent System|The Evolution Everolimus-Eluting Monorail Coronary Stent System is a device/drug combination comprised of two regulated components: a device (coronary stent stent) and a drug product (a formulation of everolimus contained in a biodegradable polymer coating).
16233483|NCT01135212|Drug|Fimasartan 60mg|Fimasartan 60mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning.
16233484|NCT01135212|Drug|Fimasartan 120mg|Fimasartan 120mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning.
16233485|NCT01135212|Drug|Candesartan cilexetil|Candesartan 8mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning.
16233486|NCT01135199|Drug|pomalidomide (CC-4047|
16233487|NCT01135186|Drug|sapropterin dihydrochloride|sapropterin dihydrochloride: 10mg/kg/day
16233488|NCT01135173|Behavioral|Waterpipe smoking cessation|The main objective of this study is to compare two levels of intensity of a behavioral intervention for waterpipe smoking cessation, using a randomized controlled trial design. In this trial, brief motivational intervention with self-help materials will be compared with intensive behavioral counseling with four sessions, in order to test the efficacy of each of these interventions. This pilot testing will help us; 1) test the potential efficacy of the developed intervention, 2) fine-tune the intervention in terms of content and format, and 3) assess issues related to recruitment and retention. Thus, feedback from participants and intervention staff will form an essential part of this pilot study to assess the adopted approaches and suggest appropriate modifications.
16233489|NCT01135147|Behavioral|Diet|Dietary therapy and physical education
16233490|NCT01135147|Procedure|Surgery|Adenotonsillectomy along with diet and physical therapy
16233491|NCT01135134|Drug|Mometasone furoate|"The study drug is MFNS (50 μg spray device) and the dose will be:
~5 to 11 years: one spray per nostril once daily (100 μg/day as MF) in the morning for 2 weeks
~12 to 15 years: 2 sprays per nostril once daily (200 μg/day as MF) in the morning for 2 weeks"
16233492|NCT01135134|Drug|Placebo|"MF Placebo nasal spray and administration will be as follows:
~5 to 11 years: one spray per nostril once daily in the morning for 2 weeks
~12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks"
16233493|NCT01135108|Drug|Placebo|Placebo IV Infusion
16233494|NCT01135108|Drug|KAI-1678|KAI-1678 IV Infusion
16233495|NCT01135095|Radiation|low-dose imaging|"The study is designed to assess the validity of a low dose (~5mSv) Tc99m one day protocol using D-SPECT standard protocol as the comparators.
~D-SPECT cardiac scanner the D-SPECT system uses a solid-state detector, made of an alloy of Cadmium, Zinc, and Telluride, eliminating the need for thick crystals and large photomultiplier tubes. As a result, the system is significantly miniaturized, and ergonomically optimized to both user and patient"
16233496|NCT01135082|Biological|valent pneumococcal conjugated vaccine|Dosage: 0.5 ml per dose Administration: intramuscular injection Location: left deltoid area x 1 injection Frequency: depend on first dose of vaccination. If 2-6 months of age, vaccination at month 0, 2, and 4. If 7-23 months of age, vaccination at month 0 and 2. If 2-9 years of age, vaccination at month 0. If patient is HIV positive, vacciation months 0 and 2 if age is 2-9 years.
16233497|NCT01135069|Drug|Tretinoin microsphere 0.1%|Treatment of acne vulgaris
16233498|NCT01135069|Drug|Brand Retin-A Micro tretinoin microsphere gel 0.1%|Treatment of acne vulgaris
16233499|NCT01135069|Drug|placebo microsphere gel|treatment of acne vulgaris
16233500|NCT01135056|Device|SIR-Spheres|One time treatment. Dose administered based on tumour volume. Each vial is 3.0GBq.
16233501|NCT01135056|Drug|Sorafenib tosylate|Oral Tablet, 400mg B.i.d, until progression or unacceptable toxicity develops
16233502|NCT01135043|Behavioral|education by brochure|educated with the brochure that contains figure of lung/upper respiratory tract and methods of collecting sputum.
16233503|NCT01135043|Behavioral|control|patients with control group are educated about methods of collecting sputum by a physician, only in verbal explanation without brochure
16233504|NCT01135030|Procedure|Total knee|Primary Total knee
16233505|NCT01135017|Drug|Dronedarone|"Film-coated tablet
~Oral administration under fed conditions (during breakfast and dinner)"
16233506|NCT01135017|Drug|Placebo (for Dronedarone)|"Film-coated tablet strictly identical in appearance
~Oral administration under fed conditions (during breakfast and dinner)"
16233507|NCT01135004|Procedure|Thoracoscopic bullectomy|Thoracoscopic wedge resection of the diseased lung
16233508|NCT01134991|Drug|Topical Minocycline Foam FXFM244|FXFM244 - 1%, FXFM244 - 4% or Placebo to be applied twice daily during 12 weeks
16233509|NCT01134978|Behavioral|Practice Order|"Blocked order - predictable
~Random order - unpredictable"
16233510|NCT01134965|Drug|Flibanserin plus Digoxin|Flibanserin 100 mg once daily for 7 days plus Digoxin 0.5 mg as single dose
16233511|NCT01134965|Drug|Digoxin|Digoxin 0.5 mg as single dose
16233512|NCT01134952|Drug|Mycophenolate to sirolimus switch|Sirolimus given for 3 months instead of mycophenolate at a starting dose equivalent of 1 mg sirolimus equal to 1000 mg of mycophenolate.
16233887|NCT01132313|Drug|BI 201335|16 weeks, QD
16233513|NCT01134926|Drug|misoprostol|8oo mcg intravaginal, second dose after one day if there is no response
16233514|NCT01134900|Other|Pharmacy Dashboard Review and Intervention|Clinical pharmacist reviews patients on dashboard and makes intervention with providing team when necessary.
16233515|NCT01134887|Other|Informational Guide for Patients|"Veterans received a copy of the NIA guide for Talking with Your Doctor. This pamphlet was specifically developed for this purpose (updated in 2002). It has pictorials and is written at an 8th grade level."
16233516|NCT01134887|Behavioral|Video-Assisted Coaching|Physicians participated in an audiotaped intensive 30 minute, one-on-one educational intervention with PI Frankel after their first set of visits from their three participating patients, but before seeing them for follow-ups. The main goal of this video-assisted coaching session was to review and discuss the analysis of the physician's videotaped visits using the Four Habits framework, with a particular focus on improving communication about self-management.
16233517|NCT01134887|Other|Monograph for Physicians|"Primary care providers randomly assigned to the Intervention-Physicians arm of this study received a copy of the Four Habits of Highly Effective Physicians. The Four Habits provided practical evidence-based advice for improving patient-physician communication."
16233518|NCT01134887|Behavioral|Educational Coaching|an educator met with each Veteran in the intervention arm individually for 20-30 minutes to review the material in the pamphlet and develop a plan for enhancing communication about self-management of hypertension with their doctor [Coaching]. To facilitate communication change, the educator assisted the patient in setting a goal to achieve during their visit. The educator also provided telephone follow-up within 24 hours to review satisfaction and effectiveness of the visit and assess barriers and facilitators to communicating about self-management.
16233519|NCT01134887|Other|Control|"The primary care providers randomly assigned to the Control-Physicians arm did not receive any additional coaching or resources and conducted their practice as usual."
16233520|NCT01134874|Behavioral|Standard weight loss intervention|In-person weight loss sessions, dietary intake prescription of 1200-1500 kcal per day, exercise progressing to 300 minutes per week.
16233521|NCT01134874|Behavioral|Standard weight loss intervention plus technology|In-person weight loss sessions, dietary intake prescription of 1200-1500 kcal per day, exercise progressing to 300 minutes per week, plus technology to provide real-time feedback on energy expenditure, plus a website to log dietary intake.
16233522|NCT01134874|Behavioral|Technology only|One intervention telephone call per month, dietary intake prescription of 1200-1500 kcal per day, exercise progressing to 300 minutes per week, plus technology to provide real-time feedback on energy expenditure, plus a website to log dietary intake.
16233523|NCT01134861|Drug|cisplatin|100 mg/m2 i.v. over 30-60 minutes, days 1 & 29
16233524|NCT01134861|Drug|Etoposide|Oral etoposide given 50 mg b.i.d. X 10 only on RT treatment days 1-5, 8-12, 29-33, and 36-40. 75 mg/day if body surface area < 1.7 m2
16233525|NCT01134861|Drug|Vinblastine|5 mg/m2 i.v. bolus weekly first 5 weeks of RT
16233526|NCT01134861|Radiation|Radiation therapy|63 Gy/7 wks/34 daily fractions (1.8 Gy X 25 fx then 2.0 Gy X 9 fX) beginning day 50 of protocol treatment
16233527|NCT01134861|Drug|Cisplatin|50 mg/m2 i.v. over 30-60 minutes on days 1, 8, 29, and 36
16233528|NCT01134861|Radiation|Radiation therapy|63 Gy/7 wks/34 daily fractions (1.8 Gy X 25 fx then 2.0 Gy X 9 fx) beginning day 1 of protocol treatment
16233529|NCT01134861|Radiation|Radiation therapy|69.6 Gy/6 wks/58 X 1.2 Gy twice daily fractions (at least 6 hours apart) beginning day 1 of protocol therapy
16233530|NCT01134848|Drug|Morphine|10mg IM
16233531|NCT01134848|Drug|Neostigmine|1mg IM
16233532|NCT01134848|Drug|0.9% saline|0.1 ml/kg
16233533|NCT01134848|Drug|Secretin|1 unit/kg IV
16233534|NCT01134848|Drug|0.9% saline|1ml IM
16233535|NCT01134835|Other|placebo|placebo 30mg daily by mouth for 4 weeks then 45mg daily for 8 weeks
16233536|NCT01134835|Drug|IMP Pioglitozone|Pioglitazone 30mg daily by mouth for 4 weeks then 45mg daily for 8 weeks and placebo 30mg daily by mouth for 4 weeks then 45mg daily for 8 weeks.
16233537|NCT01134809|Procedure|Major abdominal surgery|All adult patients having major abdominal surgery
16233538|NCT01134783|Behavioral|CHOICES Intervention|Academic course on healthy weight behaviors followed by participation in a social networking and social support website.
16233539|NCT01134757|Biological|house dust mite and alternaria allergen bronchial challenge|2 ml of saline-dissolved lyophylised house dust mite or alternaria in concentration 5000 standard biological units (SBU/ml) The challenge is the only intervention. dosed in 6 steps of 5, 10, 20, 40, 80, and 160 SBU. 10 minutes after each step up a spirometry will be performed the challenge will be stopped in case of a ≥ 20% decrease from baseline in FEV1 (PD20) and 0,2 mg Salbutamol will be given.
16233540|NCT01134731|Drug|paliperidone|1-5 mg daily (QD)
16233541|NCT01134731|Drug|lithium|300-1500mg QD
16233542|NCT01134731|Drug|Placebo|1-5 placebo capsules
16233543|NCT01134718|Drug|TMC435 (G006)|one morning dose of 150 mg
16233544|NCT01134718|Drug|TMC435 (F021)|one morning dose of 150 mg
16233545|NCT01134718|Drug|TMC435 (G007)|one morning dose of 150 mg
16233546|NCT01134705|Drug|Beclomethasone dipropionate hydrofluoroalkane HFA Nasal Aerosol|Beclomethasone dipropionate (BDP) Hydrofluoroalkane (HFA) Nasal Aerosol
16233547|NCT01134705|Drug|Placebo Nasal Aerosol|HFA Vehicle Aerosol
16233548|NCT01134692|Drug|Propranolol, Norfloxacin, VSL#3|Propranolol: as per heart rate titration Norfloxacin: 400mg BD
16233549|NCT01134679|Behavioral|Multi-disciplinary disease management approach|Follow up with phone calls
16233550|NCT01134666|Drug|Cetuximab|FOLFOX Oxaliplatin 100 mg/ m2 day 1 Folinic Acid 400 mg/m² (racemic) or 200 mg/m² (L-form) day 1 5- FU 400 mg/m² bolus on day 1 followed by a 46-hour continuous infusion of 2,400 mg/m² day 1 FOLFIRI Irinotecan 180 mg/ m2 day 1 Folinic Acid 400 mg/m² (racemic) or 200 mg/m² (L-form) day 1 5- FU 400 mg/m² bolus on day 1 followed by a 46-hour continuous infusion of 2,400 mg/m² day 1 CETUXIMAB Cetuximab administered at loading dose of 400 mg/m2/week over 120 min followed by maintenance dose of 250 mg/m2/ week over 60 min, till disease progression or dose limiting toxicity
16233551|NCT01134653|Other|Jump Stretch|distraction with early mobilization
16233552|NCT01134627|Drug|Minocycline|Participants who are self-administering Rebif® (IFN beta-1a) 44 microgram (mcg) as subcutaneous (sc) injection thrice weekly will also receive minocycline 100 milligram (mg) tablet twice daily as an add-on therapy in accordance with clinical practice for 96 weeks.
16233553|NCT01134627|Drug|Placebo|Participants who are self-administering Rebif® (IFN beta-1a) 44 mcg as sc injection thrice weekly will also receive placebo tablets twice daily for 96 weeks.
16233554|NCT01134614|Biological|Ipilimumab|Given IV
16233555|NCT01134614|Biological|Sargramostim|Given SC
16233556|NCT01134601|Procedure|Radiation Therapy|
16233557|NCT01134601|Drug|Capecitabine|
16233558|NCT01134601|Drug|AZD6244|
16233559|NCT01134588|Other|Paper questionnaire|
16233560|NCT01134588|Other|Touch screen questionnaire|
16233561|NCT01134575|Drug|CMC-544 (Inotuzumab Ozogamycin)|"First patients > 16 years and < 16 years receive CMC-544 at a dose of 1.3 mg/m^2 by vein (IV) over 1 hour during Course 1, and 1.8 mg/m^2 IV over 1 hour during Course 2 and subsequently. In all other patients beginning dose of 1.8 mg/m^2 IV over 1 hour every 4 week cycle.
~Part 2 CMC-544 (Inotuzumab Ozogamycin) 0.8 mg/m^2 IV over 1 hour (+ 15 minutes) on Day 1, 0.5 mg/m^2 IV over 1 hour (+ 15 minutes) on Day 8, and 0.5 mg/m^2 IV over 1 hour (+ 15 minutes) on Day 15. Weekly doses can be given at + 1 day. Course may be repeated every 3 weeks. Rituximab will be given on Day 1 and CMC-544 on Day 2 of the first dose; with subsequent weekly doses, both will be given weekly, rituximab preceding CMC-544. The weekly dose of rituximab will be 375 mg/m2."
16233562|NCT01134575|Drug|Rituximab|With no improvement after 2 courses of CMC-544, addition of Rituximab dose 375 mg/m^2 IV (by vein) over 2-6 hours every 3-4 weeks.
16233563|NCT01134562|Drug|Placebo|Single IV injection.
16233564|NCT01134562|Drug|Etelcalcetide|Single IV injection. The initial dose was 5 mg and dose escalation proceeded with subsequent doses of 10 mg, 20 mg, 40 mg and 60 mg.
16233565|NCT01134549|Drug|Etelcalcetide|Administered as a single intravenous (IV) injection
16233566|NCT01134549|Drug|Placebo|Administered as a single intravenous (IV) injection
16233567|NCT01134536|Drug|Tapentadol (OS) Oral Solution|Tapentadol OS Bodyweight <20 kg: Type=4 unit=mg/mL form=oral solution route=oral use or Tapentadol OS Bodyweight >=20 kg: Type=20 unit=mg/mL form=oral solution route=oral use. Single oral dose administered once.
16233568|NCT01134523|Drug|Epirubicin, CTX, Paclitaxel|Epirubicin 90mg/m2 and CTX 600mg/m2 on day1 of each 21-day cycle, 4 cycles; followed by Paclitaxel 175mg/m2 on day1 of each 21-day cycle, 4 cycles.
16233569|NCT01134523|Drug|Epirubicin, Paclitaxel|Epirubicin 75mg/m2 on day1 and Paclitaxel 175mg/m2 on day2 of each 21-day cycle, 6 cycles.
16233570|NCT01134510|Drug|C1 Esterase Inhibitor|C1 Esterase Inhibitor 20 units/kg twice weekly x 4 weeks
16233571|NCT01134510|Drug|Placebos|NS (comparable volume as intervention) twice weekly x 4wks
16233572|NCT01134497|Drug|Placebo|The control arm will consist of up to 6 cycles of carboplatin (AUC5 q21d for 6 cycles) iv over 30 minutes on day 1, plus placebo by mouth on days 1-21 of a 21 day cycle
16233573|NCT01134497|Drug|ZD4054|The experimental arm will consist of up to 6 cycles of carboplatin (AUC5 q21d for 6 cycles) iv over 30 minutes on day 1, plus ZD4054 (10mg daily) od by mouth on days 1-21 of a 21 day cycle.
16233574|NCT01134484|Drug|Velcade|"INDUCTION THERAPY: 1.3 mg/sqm as a bolus i.v. injection on days 1, 4, 8 and 11 (3 courses, 21 days each)
~REMISSION CONSOLIDATION THERAPY: 1.3 mg/sqm as a bolus i.v. injection on days 1, 8, 15 and 22 (2 courses, 35 days each)"
16233575|NCT01134484|Drug|Thalidomide|"INDUCTION THERAPY: 100 mg/d on days 1-14, 200 mg/d on days 15-63 (in case of delay of HD-CTX , Thalidomide will be continued until the day before Cyclophosphamide as priming therapy for PBSC collection)
~AFTER PBSC COLLECTION: 100 mg/d from day after last PBSC collection until the day before first course of MEL-200
~AFTER FIRST TRANSPLANTATION: 100 mg/d from recovery of hematopoiesis until the day before the second course of MEL-200
~REMISSION CONSOLIDATION THERAPY (starting 3 months after the second autologous transplantation): 100 mg/d days 1-70"
16233576|NCT01134484|Drug|Dexamethasone|"INDUCTION THERAPY
~VTD ARM: 40 mg/d days 1-2, 4-5, 8-9 and 11-12 (3 cycles, 21 days each)
~TD ARM: 40 mg/d days 1-4 and 9-12 (3 cycles, 21 days each)
~AFTER PBSC COLLECTION: 40 mg/d for 4 days (starting the same day of resumption of Thalidomide)
~AFTER FIRST TRANSPLANTATION: 40 mg/d for 4 days (starting the same day of resumption of Thalidomide) and repeated every 28 days, for 3 months
~REMISSION CONSOLIDATION THERAPY (starting 3 months after the second autologous transplantation)
~VTD ARM: 40 mg/d days 1-2, 8-9, 15-16 and 22-23 (2 cycles, 35 days each)
~TD ARM: 40 mg/d days 14 and 20-23 (2 cycles, 35 days each)"
16233577|NCT01134484|Procedure|Peripheral Blood Stem Cell (PBSC) collection|"Cyclophosphamide (CTX): 4 g/sqm given in a single day (day 0)
~G-CSF: 10 µcg/kg/d, starting on day +2 from CTX and continuing until completion of PBSC collection"
16233578|NCT01134484|Procedure|First Autologous Transplantation|"HIGH-DOSE MELPHALAN (MEL-200): 200 mg/sqm, given as a single dose i.v. (day -2) followed by PBSC infusion 48 hours later (day 0)
~G-CSF: 5 µcg/kg daily starting from day +6 after grafting and continuing until the patient's ANC is more than 0.5x10^9/L for 3 consecutive days"
16233579|NCT01134484|Procedure|Second Autologous Transplantation|"HIGH-DOSE MELPHALAN (MEL-200): 200 mg/sqm, given as a single dose i.v. (day -2) followed by PBSC infusion 48 hours later (day 0)
~G-CSF: 5 µcg/kg daily starting from day +6 after grafting and continuing until the patient's ANC is more than 0.5x10^9/L for 3 consecutive days"
16233580|NCT01134471|Device|Ostene|applied to sternal surface
16233581|NCT01134471|Device|Bonewax|applied to sternal surface
16233582|NCT01134458|Behavioral|Web-Based Intervention|"Health Dialog Cardiac Risk Calculator
~Health Dialog's Living with Coronary Heart Disease
~Tailored intervention including health behavior modules such as smoking cessation, exercise, diet, and weight"
16233583|NCT01134445|Device|DePuy Proxima™ Hip|A short, anatomic, cementless femoral component for use in total hip arthroplasty
16233584|NCT01134432|Drug|prednisolone + mabthera|"Prednisolone: 1,5 mg/kg for two weeks with gradually reduced dosis over two months.
~Mabthera: 375 mg/m2 once a week for four weeks"
16233585|NCT01134432|Drug|Prednisolone|Prednisolone: 1,5 mg/kg for two weeks and then gradually reduced dosis over two months
16233586|NCT01134419|Other|Computerized handoff tool|Informatics tool to aid in transfer of patient care information
16233587|NCT01134419|Other|Team training|Teamwork training and revisions of handoff structure to optimize teamwork skills and verbal communications
16233588|NCT01134406|Device|Hydros Joint Therapy|Single intra-articular injection.
16233589|NCT01134406|Device|Hydros-TA Joint Therapy|Single intra-articular injection
16233590|NCT01134406|Device|Synvisc-One|Single intra-articular injection.
16233591|NCT01134393|Drug|telmisartan/amlodipine|start low dose and uptitrate to high dose on the basis of BP goal
16233592|NCT01134341|Drug|Pralatrexate Injection|"Intravenous (IV) push over 30 seconds to 5 minutes via a patent free-flowing IV line containing normal saline (0.9% sodium chloride).
~10 or 15 mg/m2, depending on cohort assignment.
~Dose reductions allowed for protocol-specified criteria.
~Administered weekly for 3 weeks of 4-week cycle (weekly for 3 weeks with one week of rest) until criteria for discontinuation per the protocol are met."
16233593|NCT01134341|Drug|Bexarotene Capsules|"150 or 300 mg orally, depending on cohort assignment. Provided as 75 mg capsules and taken with a meal.
~Dose reductions allowed for protocol-specified criteria and implemented per the Targretin® package insert.
~Administered daily until criteria for study treatment discontinuation per the protocol are met."
16233594|NCT01134341|Dietary Supplement|Vitamin B12|"1 mg intramuscular injection
~Administered within 10 weeks prior to start of study treatment, every 8-10 weeks throughout the study and for 30 days after last study treatment (dose of pralatrexate or bexarotene)."
16233595|NCT01134341|Dietary Supplement|Folic Acid|"1-1.25 mg orally
~Administered daily for at least 7 days prior to start of study treatment, throughout the study and for 30 days after last study treatment (dose of pralatrexate or bexarotene)."
16233596|NCT01134328|Drug|AC-150 Combo|1 drop in each eye for up to 14 days
16233597|NCT01134328|Drug|AC-150A 0.1%|1 drop in each eye once per day for up to 14 days
16233598|NCT01134328|Drug|AC-150B 0.005%|1 drop in each eye once per day for up to 14 days
16233599|NCT01134328|Drug|Vehicle|1 drop in each eye once per day for up to 14 days
16233600|NCT01134315|Drug|Paricalcitol|
16233601|NCT01134315|Drug|Calcitriol|
16233602|NCT01134302|Procedure|Norwood management strategy|Norwood palliation will be performed as per current clinical practice at The Hospital for Sick Children.
16233603|NCT01134302|Procedure|Hybrid Strategy|"Hybrid palliation will be performed as per current clinical practice at The Hospital for Sick Children.
~The 'Hybrid' management strategy utilizes catheter-based and non-open heart surgical procedures in the neonatal period to stabilize the neonate.10 The majority of the reconstruction is thereby deferred to 4-6 months of age, at which time the second stage procedure including an aortic arch reconstruction is performed. The third stage procedure (Fontan) is identical between Norwood and Hybrid strategies."
16233604|NCT01134289|Procedure|lumbar sympathetic block|unilateral lumbar sympathetic block at L3 level using 0.2% chirocaine under C-arm fluoroscopy
16233605|NCT01134276|Procedure|biliary drainage|biliary drainage via PTBD or ERBD/ENBD
16233606|NCT01134263|Biological|Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus|0.5 ml, Subcutaneous (SC)
16233607|NCT01134263|Biological|Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus|0.5 ml, SC
16233608|NCT01134263|Biological|Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus|0.5 ml, SC
16233609|NCT01134263|Biological|Live, attenuated, recombinant dengue serotypes 1, 2, 3, & 4 virus|0.5 ml, Subcutaneous (SC)
16233610|NCT01134263|Biological|Placebo: NaCl 0.9%|0.5 ml, SC
16233611|NCT01134250|Drug|F16IL2 in combination with paclitaxel|"Intravenous (i.v.) infusions of F16IL2 (Dose escalation: from 5 to 35 MioIU, the dose could be further increased until MTD is reached, following a pharmacokinetic-guided design) on days 1, 8, 15, 29, 36 and 43 over 60 minutes via automated device (perfusor), followed by a 1 hour i.v. infusion of paclitaxel (Dose escalation: from 60 up to 90 mg/m2) on days 1, 8, 15, 29, 36 and 43.
~Patients with objective tumor responses or stable disease will receive additional combination therapy for a maximum of 6 months, or until disease progression, unacceptable toxicity or withdrawal of consent."
16233612|NCT01134237|Drug|urokinase|intrapleural urokinase injection
16233613|NCT01134237|Drug|placebo|Normal saline as a placebo for control arm
16233614|NCT01134224|Drug|insulin degludec/insulin aspart|0.4 U/kg body weight injected subcutaneously (under the skin) once
16233615|NCT01134224|Drug|insulin degludec/insulin aspart|0.6 U/kg body weight injected subcutaneously (under the skin) once
16233616|NCT01134224|Drug|insulin degludec/insulin aspart|0.8 U/kg body weight injected subcutaneously (under the skin) once
16233617|NCT01134224|Drug|biphasic insulin aspart 30|0.4 U/kg body weight injected subcutaneously (under the skin) once
16233618|NCT01134224|Drug|biphasic insulin aspart 30|0.6 U/kg body weight injected subcutaneously (under the skin) once
16233619|NCT01134224|Drug|biphasic insulin aspart 30|0.8 U/kg body weight injected subcutaneously (under the skin) once
16233620|NCT01134211|Device|nelfilcon A|Commercially marketed, single-vision, soft contact lens for daily disposable wear
16233621|NCT01134211|Device|filcon II 3|Commercially marketed, single-vision, soft contact lens for daily disposable wear
16233622|NCT01134198|Drug|Mifepristone|Mifepristone 600mg, 3x/wk for 4 weeks
16233623|NCT01134198|Drug|placebo|placebo
16233624|NCT01134185|Drug|prucalopride|single oral dose of 2 mg prucalopride
16233625|NCT01134185|Drug|prucalopride|single oral dose of 2 mg prucalopride
16233626|NCT01134185|Drug|prucalopride|single dose of 2 mg prucalopride
16233627|NCT01134172|Behavioral|survey web-based or telephone interview|Patients will be asked to complete a questionnaire at baseline, and then one at follow up, 3-4 months after treatment completion. The patient will be contacted one and two years after the completion of their follow up questionnaire for a brief one-question survey regarding current employment status. A member of the study team will call a subset of patients who have completed both baseline and follow-up surveys to clarify responses to previous questions. Patients will be considered lost to follow- up if surveys A or C have not been completed two years from the participant's consent date (participants who enroll but do not complete survey A are not prompted for survey C). Deviations will not be filed until the end of the study, as there are opportunities over the course of study follow- up to collect previously missing information.
16233655|NCT01133964|Dietary Supplement|dairy proteins|Protein drinks with 3.5% protein. The protein source will be whey, casein or whey and casein (20:80; normal content in the milk). In the arm with water no protein will be added.
16233656|NCT01133951|Drug|OAC triple therapy|Omeprazole, 20mg, amoxicillin, 1000mg, and clarithromycin, 500mg, all twice a day for 2 weeks.
16233657|NCT01133951|Drug|Placebo|Omeprazole placebo, amoxicillin placebo, and clarithromycin placebo, all twice a day for 2 weeks.
16233658|NCT01133925|Device|Resolute Sprint|Zotarolimus Eluting Stent (Resolute Sprint) implanted in overlap
16233659|NCT01133925|Device|Sirolimus Eluting Stent|Cypher stents implanted in overlap
16233660|NCT01133925|Device|Paclitaxel Eluting Stent|Taxus stents implanted in overlap
16233628|NCT01134172|Behavioral|survey web-based or telephone interview|Patients will be asked to complete a questionnaire at baseline, and then one at follow up, 3-4 months after treatment completion. All three follow-up contact methods (email, postcard, call) contain the same question regarding current employment status with minor modifications in formatting. However, the employment question asked in all three follow-up contact methods is shown in the Postcard_Template document. Due to the recent COVID-19 pandemic study staff will be working from home. Therefore, calls will be made via MSK-approved platforms (e.g. Jabber, etc.). Participants who express concerns or request assistance related to COVID-19 will be referred to publicly available resources as needed (e.g., call 311 for access to health care or food panties, etc.) and will be noted in internal tracking logs. The data collected for these internal tracking logs will be managed through a REDCap database.
16233629|NCT01134146|Radiation|IMRT|Delivery of whole-pleura radiation doses beginning with 1) 45 Gy to low-risk region and 60-66 Gy to high-risk region; then 2) the same dosing regimen as above with a third dosing level, 50 Gy to an intermediate-dosing region. Every weekday (Monday-Friday) for up to 5 weeks, lasting about 45-60 minutes.
16233630|NCT01134133|Other|Anti-gurgling intervention|1. head of bed 30 degrees or higher, 2. swallowing evaluation-based feeding, 3. sedatives titrated to minimal effective dose.
16233631|NCT01134120|Drug|LY2784544|LY2784544 will be supplied as a capsule. The study drug will be taken by mouth daily while the patient is on study. In this study, different patients will be treated at different doses of LY2784544 until reaching the highest dose that patients can tolerate.
16233632|NCT01134107|Drug|Insulin Lispro 6 Day (6D)|Administered by infusion pump for 12 week treatment period
16233633|NCT01134107|Drug|Insulin Aspart 6 Day (6D)|Administered by infusion pump for 12 week treatment period
16233634|NCT01134094|Procedure|Open reduction internal fixation of the ankle|The specific procedure for each patient managed operatively, both in the observational study and the RCT, will be determined by the operating surgeon. Any adverse intra-operative or post-operative event will be recorded. This includes but is not limited to death, infection and neurovascular injury. Post operatively, all patients will be NWB (non weight bearing) and placed in a POP (plaster of paris) below knee cast or walking boot. Discharge from hospital will be determined by the patient walking 25m unaided by standby assistance. The treating surgeon will review the patients after 10-14 days for a wound review, removal of sutures and change of cast to a fibreglass cast or walking boot (cam walker). The patient will be WBAT (weight bearing as tolerated) for a further 4 weeks.
16233635|NCT01134094|Procedure|Non Operative|Patients who are treated non-operatively will be treated with a walking boot and allowed WBAT. Discharge from hospital will be determined by the patient walking 25m unaided by standby assistance. All patients will be reviewed between 7 and 14 days post injury with repeat x-rays by the treating surgeon.
16233636|NCT01134081|Biological|CelTx™|CelTx™ is a living bilayered cell therapy product. CelTx™ is constructed of Type I bovine collagen (extracted from bovine tendons and subsequently purified) and viable allogeneic human fibroblasts and keratinocytes isolated from human neonatal foreskin. This is applied once in the oral cavity.
16233637|NCT01134081|Procedure|Free Gingival Graft|Harvested tissue from palate
16233638|NCT01134068|Other|Evaluation of a modified DD cut-off to rule out PE|Evaluation of a modified DD cut-off to rule out PE
16233639|NCT01134055|Drug|pazopanib eye drops|A tyrosine kinase inhibitor of multiple receptors including vascular endothelial growth factor receptors and platelet-derived growth factor receptors.
16233640|NCT01134055|Drug|placebo|placebo eye drops
16233641|NCT01134055|Biological|ranibizumab intravitreal injection|Humanized recombinant monoclonal antibody fragment targeted against human vascular endothelial growth factor A
16233642|NCT01134042|Drug|Fluticasone Furoate/Vilanterol Inhalation Powder|Fluticasone furoate/Vilanterol inhalation powder inhaled orally once daily for 24 weeks
16233643|NCT01134042|Drug|Fluticasone Furoate Inhalation Powder|Fluticasone furoate inhalation powder inhaled orally once daily for 24 weeks
16233644|NCT01134042|Drug|Fluticasone Propionate Inhalation Powder|Fluticasone propionate inhalation powder inhaled orally twice daily for 24 weeks
16233645|NCT01134042|Other|Placebo Inhalation Powder 1|Placebo in novel dry powder inhaler once daily
16233646|NCT01134042|Other|Placebo Inhalation Powder 2|Placebo in Diskus inhaler twice daily
16233647|NCT01134029|Behavioral|Stepped Care|This group receives 2 years of a stepped care intervention including provider visits, health educator sessions, phone calls and mailings and availability of self management and group sessions, text messaging and a smoker's quit line.
16233648|NCT01134016|Drug|Antroquinonol|"Antroquinonol was taken orally, daily, within 15 minutes after a breakfast at the assigned dose level: 50, 100, 200, 300, 450, 600 mg/day for 4 weeks.
~Dose Level 1 (4 weeks) : 50 mg Antroquinonol; Dose Level 2 (4 weeks) : 100mg Antroquinonol; Dose Level 3 (4 weeks) : 200mg Antroquinonol; Dose Level 4 (4 weeks) : 300mg Antroquinonol; Dose Level 5 (4 weeks) : 450mg Antroquinonol; Dose Level 6 (4 weeks) : 600mg Antroquinonol.
~The accelerated phase ended when either 1 DLT or MT was observed to start standard phase. Study ended when reach the highest dose level or DLT founded."
16233649|NCT01133990|Drug|FOLIRI|The FOLFIRI regimen consists of irinotecan at 180 mg/m2 (IV infusion) on Day 1 and Day 15 of each 28-day cycle, leucovorin at 200 mg/m2 (400 mg/m2 if using d,l-racemic mixture of leucovorin) by IV infusion on Days 1 and 15 of each cycle, and 5-FU at 400 mg/m2 as an IV bolus injection followed by a total of 2400 mg/m2 by CIV infusion over 46 hours over Days 1 and 2 via an ambulatory programmable pump (the use of an ambulatory pump is optional). The 5-FU IV bolus (400 mg/m2) and CIV infusion (2400 mg/m2) over 46 hours is repeated on Days 15 and 16 of each cycle.
16233650|NCT01133990|Drug|FOLIRI plus E7820|E7820 is administered orally in tablet form once daily, every day of each 28-day treatment cycle. For the Phase Ib portion, the doses will be 40 mg/day, 70 mg/day, and 100 mg/day, and for the Phase II portion, the dose will be the MTD recommended Phase IB dose in combination with FOLFIRI, as determined during the Phase Ib portion of the study.
16233651|NCT01133990|Drug|FOLFIRI plus Bevacizumab|Bevacizumab at 5 mg/kg (IV infusion) on Days 1 and 15 of each 28-day treatment cycle
16233652|NCT01133977|Drug|Lenvatinib|Lenvatinib tablets administered orally at doses of 16 mg, 20 mg, or 22 mg, once daily continuously over 3 weeks (21 days) during each 21-day cycle
16233653|NCT01133977|Drug|Lenvatinib|Lenvatinib 20 mg (MTD/recommended Phase 2 dose as determined in Phase 1b of the study) administered once daily continuously over 3 weeks (21 days) during each 21-day cycle
16233654|NCT01133977|Drug|Dacarbazine|Dacarbazine (1000 mg/m2) infusion over 60 minutes on Day 1 of each 21-day cycle.
16233662|NCT01133912|Drug|paclitaxel, gemcitabine, lapatinib|Patients receive paclitaxel and gemcitabine intravenously (iv) on day 1 and 8, and oral lapatinib once daily. Lapatinib with fixed dose will be given once a day p.o. from day 1 without resting during each cycle. The starting doses of paclitaxel 80mg/m2 and gemcitabine 1000mg/m2 iv, on day 1 and 8, and lapatinib 1000mg p.o., daily (dose level 1) will be administered every 21 days.
16233663|NCT01133899|Dietary Supplement|guanidinoacetic acid|2.4 grams of guanidinoacetic acid
16233664|NCT01133899|Dietary Supplement|GAA-4|4.8 grams of guanidinoacetic acid
16233665|NCT01133899|Dietary Supplement|GAA-1|1.2 grams of guanidinoacetic acid
16233666|NCT01133899|Dietary Supplement|PLACEBO|celulose
16233667|NCT01133886|Drug|Decitabine|Patients will receive decitabine as a 20mg/m2 one hour intravenous infusion once daily on days 1 to 5 of a 4 week cycle.
16233668|NCT01133873|Drug|Propoxyphene napsylate (XP20C)|100 mg capsules 6 times a day in ascending doses until a maximum tolerated dose is identified
16233669|NCT01133873|Drug|Placebo|6 times a day in ascending doses until a maximum tolerated dose is identified
16233670|NCT01133860|Drug|eltrombopag|Eltrombopag, administered orally, 50 mg/daily for 21 days. Patients with platelet counts between 100 and 150x10e9/L at day 21 will continue eltrombopag 50 mg/daily for 21 additional days. Patients with platelet count lower than 100x10e9/L at day 21 will receive eltrombopag 75 mg/daily for additional 21 days. Patients with more than 150x10e9 platelets/L at day 21 will stop therapy.
16233671|NCT01133847|Drug|Methylphenidate|Appropriate dosage to be individually determined; daily for 16 weeks
16233672|NCT01133847|Behavioral|Intensive reading instruction|Individualized phonologically-based instruction delivered 4 days per week for 45 min. per day by a highly trained tutor.
16233673|NCT01133847|Behavioral|Parent Training|Nine sessions on parenting a child with ADHD
16233674|NCT01133847|Drug|Mixed Salt Amphetamine|Appropriate dosage to be individually determined; daily for 16 weeks; prescribed only if child does not show a beneficial treatment response to Concerta
16233675|NCT01133847|Drug|Atomoxetine|Appropriate dosage to be individually determined; daily for 16 weeks
16233676|NCT01133847|Drug|Guanfacine|Appropriate dosage to be individually determined; daily for 16 weeks
16233677|NCT01133821|Drug|IPSRT plus placebo (IPSRT-PLA)|"Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment.
~The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo).
~Medication Dosing
~The research pharmacy will dispense medication in the following unit-dose packs:
~Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA)"
16233678|NCT01133821|Drug|IPSRT plus quetiapine|"Subjects will be seen approximately weekly/biweekly during the 20 week acute phase. All subjects will return at weeks 36 and 52 for follow-up assessments to evaluate the enduring effects of treatment.
~The therapist will administer IPSRT and the psychiatrist will administer medication management procedures (quetiapine or placebo).
~Medication Dosing
~The research pharmacy will dispense medication in the following unit-dose packs:
~Dose A (50 mg of QUE or PLA) Dose B (100 mg of QUE or PLA) Dose C (separate packs of 50 mg and 100 mg QUE capsules or PLA) Dose D (200 mg of QUE or PLA) Dose E (separate packs of 50 mg and 200 mg QUE capsules or PLA) Dose F (separate packs of 100mg and 200mg QUE capsules or PLA)"
16233679|NCT01133795|Drug|Midodrine plus Albumin|MIdodrine 10mg tid for 12 weeks. Albumin 40g every 14 days for 12 weeks
16233680|NCT01133782|Procedure|Access to diagnostic test|Randomization to receive a result of diagostic procedure the following day.
16233681|NCT01133756|Drug|Lenvatinib|lenvatinib (as 1mg, 4mg, and 10mg tablets) was administered orally, once daily continuously for each 21-day treatment cycle.
16233682|NCT01133756|Drug|Carboplatin|Carboplatin was to be administered on Day 1 of every 21-day cycle at a dose AUC 4 over 30 minutes.
16233683|NCT01133756|Drug|Gemcitabine|Gemcitabine was to be administered on Day 1 and Day 8 of every 21-day cycle at a dose of 1000 mg/m2 over 30 minutes.
16233684|NCT01133743|Drug|Lenalidomide and Dexamethasone|Starting Lenalidomide dose 2.5 mgs or 5 mgs (based on baseline calculated creatinine clearance)PO daily on a 28 day cycle. Dose escalations will take place at the start of subsequent cycles as frequently as tolerated but not more frequently than at the start of each cycle to a target dose of 25mg daily. Oral dexamethasone at 12 mg PO daily will be administered on days 1-7, 14 and 21 of each cycle
16233685|NCT01133730|Drug|Active treatment|US-guided TFP block with 20ml 0.5% ropivacaine + 1:200 000 epinephrine
16233686|NCT01133730|Drug|Placebo Arm|US-guided TFP block with 20ml of 5% dextrose solution
16233687|NCT01133704|Biological|sipuleucel-T|
16233688|NCT01133704|Biological|APC-Placebo|
16233689|NCT01133691|Dietary Supplement|clear fluid, light breakfast|clear fluid 7 ml/kg, breakfast consisting of yoghurt, muesli, mild
16233690|NCT01133678|Drug|Everolimus|Phase II Portion (2 21-day cycles of induction therapy) Cisplatin (75 mg/m2 day 1) Paclitaxel (175 mg/m2, day 1) Cetuximab(400 mg/m2 loading dose day 1 then 250mg/m2 weekly ) Everolimus 5 mg PO daily. Following induction patients received [paclitaxel (100 mg/m2 IV weekly), 5-FU (600 mg/m2 IV day 1-5), hydroxyurea 500 mg BID PO (day 1-5), and hyperfractionated twice daily radiotherapy (150 cGy per fraction) day 1-5 of a 14 day cycle which is repeated to deliver the prescribed radiotherapy dose.
16233691|NCT01133678|Drug|Placebo|Phase II Portion (2 21-day cycles of induction therapy) Cisplatin (75 mg/m2 day 1) Paclitaxel(175 mg/m2, day 1) Cetuximab(400 mg/m2 loading dose day 1 then 250mg/m2 weekly ) Placebo PO daily. Following induction patients received [paclitaxel (100 mg/m2 IV weekly), 5-FU (600 mg/m2 IV day 1-5), hydroxyurea 500 mg BID PO (day 1-5), and hyperfractionated twice daily radiotherapy (150 cGy per fraction) day 1-5 of a 14 day cycle which is repeated to deliver the prescribed radiotherapy dose.
16233692|NCT01133665|Drug|Cetuximab and Lenalidomide|The treatment of Head and Neck Cancer with Cetuximab and Lenalidomide
16233693|NCT01133652|Device|Veinviewer|Veinviewer machine
16233694|NCT01133652|Device|Ultrasound|Ultrasound
16233695|NCT01133652|Other|Conventional technique|Conventional IV placement by nurses
16233696|NCT01133639|Drug|Ketorolac|30 mg IV dose intra-operatively followed by 10 mg orally every 8 hours for five days plus standard of care
16233697|NCT01133639|Drug|Placebo|Placebo plus standard of care
16233698|NCT01133626|Drug|Placebo Nasal Aerosol|Placebo nasal aerosol administered daily for 42 days of treatment
16233699|NCT01133626|Drug|Prednisone capsules|Prednisone 10 mg capsule taken each day on the last 7 days of treatment
16233700|NCT01133626|Drug|Placebo Prednisone Capsules|Placebo prednisone capsule taken each day on the last 7 days of treatment
16233701|NCT01133626|Drug|Beclomethasone dipropionate|Total daily dose of 320 micrograms per day of beclomethasone dipropionate (BDP) hydrofluoroalkane (HFA) applied as a nasal aerosol each morning for 42 days.
16233702|NCT01133613|Drug|Bone morphogenetic protein 7|Single intraarticular injection of BMP-7 or placebo on Day 1
16233703|NCT01133600|Drug|Cubicin|dosed at 6 mg/kg body weight intravenously every 24 hours with a reduction to 6mg/kg every other day if CrCl is <30ml/min.
16233704|NCT01133600|Drug|Vancomycin|dosed at 15mg/kg intravenously every 12 hours with adjustments for renal function.
16233705|NCT01133587|Other|wait list control|"Patient-guided admissions contract regarding patient-guided admissions starting a year after."
16233706|NCT01133587|Behavioral|admissions contract|"contract regarding patient-guided admissions starting immediately"
16233707|NCT01133574|Drug|SLV354 capsules|20 mg
16233708|NCT01133574|Drug|SLV354 capsules|60 mg
16233709|NCT01133574|Drug|SLV354 capsules|120 mg
16233710|NCT01133574|Drug|SLV354 capsules|250 mg
16233711|NCT01133574|Drug|SLV354 capsules|500 mg
16233712|NCT01133574|Drug|SLV354 capsules|750 mg
16233713|NCT01133574|Drug|SLV354 capsules|1000 mg
16233714|NCT01133574|Drug|SLV354 capsules|1250 mg
16233715|NCT01133574|Drug|Placebo capsules|placebo
16233716|NCT01133574|Drug|SLV354 capsules|low dose group 1
16233717|NCT01133574|Drug|SLV354 capsules|high dose group 1
16233718|NCT01133574|Drug|SLV354 capsules|low dose group 2
16233719|NCT01133574|Drug|SLV354 capsules|high dose group 2
16233720|NCT01133574|Drug|Placebo capsules|placebo
16233721|NCT01133561|Drug|actozone A|pioglitazone 30 mg tablet , once daily dose for 10 weeks
16233722|NCT01133561|Drug|actozone B|one tablet of vehicle without active ingredient pioglitazone
16233723|NCT01133548|Drug|Testosterone Gel 1.62%|5 grams administered using an application Site Rotation
16233724|NCT01133548|Drug|Testosterone Gel 1.62%|5 grams administered using an a combination of Application sites
16233725|NCT01133522|Biological|Evolocumab|Administered by subcutaneous injection
16233726|NCT01133522|Biological|Placebo|Administered by subcutaneous injection
16233727|NCT01133509|Drug|Gardasil|0.5ml IM for three doses, Second and third dose to be given at 2 months and 6 months
16233728|NCT01133496|Drug|Alendronate Sodium Tablets, 70 mg|Alendronate Sodium Tablets, 70 mg of Dr. Reddy's Laboratories Limited.
16233729|NCT01133483|Drug|Fexofenadine HCl + Pseudoephedrine HCl|Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's Laboratories Limited
16233730|NCT01133470|Drug|Fexofenadine HCl + Pseudoephedrine HCl|Fexofenadine HCl 180 mg + Pseudoephedrine HCl 240 mg ER Tablets of Dr. Reddy's KLaboratories Limited
16233731|NCT01133457|Drug|Finasteride|Finasteride tablets 1 mg
16233732|NCT01133444|Drug|Finasteride|Finasteride tablets 1 mg
16233733|NCT01133431|Drug|CKD-501 0.5 mg tablet, Glimepiride 4 mg tablet|From day 1 to day 4, CKD-501 0.5mg is administered daily to Group 1 patients during period 1. Then on day 5,CKD-501 0.5mg and glimepiride 4mg is co-administered to overnight-fasting Group 1 patients at period 1. After 10 day-break, period 2 will be repeated with CKD-501 placebo and glimepiride 4mg in Group 1.
16233734|NCT01133431|Drug|CKD-501 placebo tablet, Glimepiride 4 mg tablet|From day 1 to day 4, CKD-501 placebo is administered daily to Group 2 patients during period 1. Then on day 5,CKD-501 placebo and glimepiride 4mg is co-administered to overnight-fasting Group 2 patients at period 1. After 10 day-break, period 2 will be repeated with CKD-501 0.5mg and glimepiride 4mg in Group 2.
16233735|NCT01133418|Other|Computerized Progressive Attention Training|Four comprehensive training tasks were developed and programmed based on expansions and modifications of various tasks that have been extensively investigated in the attention literature and are known to reflect primary attentional functions. Each task is discussed in detail in the Research Methods (section D.6.b). Briefly, they included a Continuous Performance Task, a Conjunctive Search Task, an Orienting and Flanker Task, and a Global-Local Task. All of the tasks were modified extensively from their original neuropsychological design to make them entertaining and stimulating enough for children to enjoy. Each task began at a relatively simple level of difficulty and gradually increased in difficulty across the training as children demonstrated proficiency according to reductions in RT variability
16233736|NCT01133418|Other|Sham Comparator Cognitive Training|Same tasks at Computerized Progressive Attention Training but the tasks do not progress in difficulty
16233737|NCT01133405|Drug|LY2886721|Oral capsules
16233738|NCT01133405|Drug|Placebo|Oral capsules
16233739|NCT01133392|Drug|Insulin lispro A|20 units (U) subcutaneously (SC).
16233740|NCT01133392|Drug|Insulin lispro B|20 U subcutaneously (SC).
16233741|NCT01133379|Device|12027-019|Rinse with 10 mL for 60 seconds twice daily after brushing in your usual manner for 1 minute using at least a one-inch strip of the assigned toothpaste.
16233742|NCT01133379|Device|12027-020|Rinse with 20 mL for 60 seconds twice daily after brushing in your usual manner for 1 minute using at least a one-inch strip of the assigned toothpaste.
16233743|NCT01133379|Device|12027-021|Rinse with 10 mL for 60 seconds twice daily after brushing in your usual manner for 1 minute using at least a one-inch strip of the assigned toothpaste
16233744|NCT01133366|Drug|warfarin sodium|25 mg of warfarin oral (single dose)
16233745|NCT01133366|Drug|mipomersen sodium; warfarin sodium|200 mg of mipomersen subcutaneous (SC) (4 doses) plus a single 25 mg of warfarin oral administered with the final mipomersen SC dose
16233746|NCT01133353|Drug|Tetrabenazine MR|Modified-Release (MR) tablets containing 15 mg or 30 mg tetrabenazine, dose-escalating up to a maximum of 150 mg depending on weight, once per day for 12 weeks
16233747|NCT01133353|Drug|Placebo|1 to 5 tablets once per day depending on weight for 12 weeks
16233774|NCT01133041|Other|Observation using NBI system|NBI system can improve the patterns of mucosal surface and vascularity of colonic polyp.
16233775|NCT01133041|Other|Observation using i-Scan system|I-Scan system can improve the patterns of mucosal surface and vascularity of colonic polyp.
16233748|NCT01133340|Radiation|Radiation|No treatment intervention is planned. Patients will be scanned and treated as per department standards. The patient will have MRI at the time of their standard plan. They will then have clips inserted to mark the tumor after the standard scan is performed. The MRI and additional imaging with clips in place will be processed by 3 investigators who will contour based on the experimental image and compare this with the standard treated plan. Comparison of volumes in a blinded manner between investigators will also occur. The patients treatment will not be affected by the MRI or clip placement.
16233749|NCT01133327|Device|Carotid Artery Stenting|"The Adapt Carotid Stent System is intended to deliver a self-expanding Stent to the extra-cranial carotid arteries via a sheathed percutaneous Monorail delivery system. The Adapt Carotid Stent is a closed cell, self-expanding, rolled nitinol (nickel-titanium alloy) sheet. The stent is thin, flexible and expands to appose the vessel wall.
~The FilterWire EZ System is a temporary intravascular guide wire filtration system that is placed in the vessel distal to the lesion to be treated. It consists of either a polyurethane filter bag 1.5 cm in length or a Bionate (polycarbonate urethane) filter bag, 1.0 cm in length attached near the distal end of a 0.014 silicone coated stainless steel guide wire by means of a collapsible, self-conforming, Nitinol filter loop wire."
16233750|NCT01133301|Drug|Naltrexone|50 mg/d Naltrexone will be administrated during three weeks.
16233751|NCT01133301|Drug|Placebo|During 3 weeks of the study, Placebo will be administrated (daily)
16233752|NCT01133288|Device|Yulex gloves|Study participants will be asked to wear Yulex gloves for routine bowel and bladder care (~30 minutes per day) over a 3 month period.
16233753|NCT01133275|Drug|Prednisone|Prednisone therapy for 6 cycles (24 weeks).
16233754|NCT01133275|Drug|Lenalidomide|Lenalidomide therapy for 6 cycles (24 weeks).
16233755|NCT01133236|Dietary Supplement|Salt and fluid restriction|"I: Intervention Prescription of low-sodium diet with additional 2 g of sodium and water restriction to 800 mL/day.
~II: Control Prescription without sodium and fluid restriction."
16233756|NCT01133223|Device|Penumbra™ System|Patients assigned to the Thrombectomy arm will be conducted to the angio suite. Mechanical thrombectomy will be attempted with the use of the Penumbra™ System, and can be assisted by intraarterial thrombolysis (rTPA up to 20 mg)
16233757|NCT01133223|Drug|Recombinant tissue plasminogen activator|Patients assigned to Usual Care arm will be thrombolysed according to the NINDS protocol (rtPA 0,9 mg/kg, 10% IV bolus and remaining in the next hour, up to 90 mg)
16233758|NCT01133210|Drug|Maraviroc|dosage will be a 300mg Maraviroc pill twice a day for 12 weeks
16233759|NCT01133210|Other|placebo|subjects will be given placebo pills with instructions to take one pill twice a day for 12 weeks.
16233760|NCT01133184|Biological|Sci B vac|Sci B vac
16233761|NCT01133171|Behavioral|Nurse Alone|Patients received two in-person counseling sessions by a research nurse, approximately 3-7 months apart, in methods for controlling cardiovascular risk factors.
16233762|NCT01133171|Behavioral|Dashboard Plus Nurse|Patients receive two in-person counseling sessions, six months apart, in methods for controlling cardiovascular risk factors and were asked to use a computerized dashboard to enter values for the risk factors and observe the effects of the risk factors on the overall cardiovascular risk.
16233763|NCT01133158|Drug|Rituximab, Bendamustine, Mitoxantrone, Dexamethasone|Bendamustine: 90 mg/m2/day, days 1 and 2 of each cycle, iv Mitoxantrone: 6 mg/m2/day, day 1 of each cycle, iv Dexamethasone 20 mg / day, days 1 through 5 of each cycle, od Rituximab: 375 mg / m 2 / day, day 1 of each cycle, iv
16233764|NCT01133145|Procedure|knee joint transplantation|transplantation of a kne joint from a multi organ donor to a recipient with a severly injured knee joint
16233765|NCT01133132|Behavioral|Survivorship CHESS|Once the consent, baseline survey and one week accelerometer data is received by the UW research team subjects will be randomized to one of the two study conditions. Subjects will be notified of their randomization. Subjects randomized to the Survivorship CHESS condition will be offered training on the smartphone and the CHESS system. The project director (and site research coordinators) will provide training on the smartphone either in person or over the phone. Additionally, an online tutorial will be included in the Survivorship CHESS intervention for subjects to refer to as needed. Participants will then be asked to complete four surveys one baseline and then three follow up surveys.
16233766|NCT01133132|Other|Control|This person will receive usual care and a copy of the National Cancer Institute's Facing Forward booklet and the National Cancer Center Network cancer survivor toolbox.
16233767|NCT01133119|Drug|Standard of Care|Subjects will have femoral sheaths removed under general anesthetic but without subcutaneous infiltration of bupivacaine.
16233768|NCT01133119|Drug|Standard of Care plus bupivacaine|"Subcutaneous dose of 0.25% bupivacaine infiltrated around the entry site of the femoral artery/vein sheath, just prior to sheath removal.
~Participants will receive a dose of up to 0.8mL/kg (up to 2.0 mg/kg) of 0.25% bupivacaine, with the final amount at the discretion of the physician."
16233769|NCT01133106|Behavioral|Brief pleasurable events/behavioral therapy|"Each participant in any arm will be given an American Stroke Association article about stroke and depression, a Stroke Smart Article about caregiver depression, and a pamphlet by the Beck Institute titled Coping with Depression.
~Each participant in Arms 1 and 2 will be given their own manual for the intervention sessions. The intervention consists of one in-person orientation session and 6 weekly sessions with the following topics introducing behavioral therapy, the role of pleasant events, problem-solving skills and generalization techniques. All participants' primary care provider or stroke care provider will receive a letter informing them of their patient's participation (but not of study assignment). This letter will include recommendations for prescribing and adjusting antidepressant treatment using established guidelines adapted for treatment of medically-ill outpatients."
16233770|NCT01133106|Other|Standard care|The standard care group (Arm C, N=75) will receive standard medical treatment from their provider, including a recommendation for antidepressants. Participants or third-party payers will pay for their antidepressants, just as they would under regular care. All participants receive written materials regarding depression from the American Stroke Association, keep medication logs and receive follow-up assessment on the same time frame as the intervention groups
16233771|NCT01133080|Drug|Minocycline|minocycline 200 mg/day orally in two divided doses for the second week. From weeks 3 to weeks 5, minocycline 400 mg/day orally in two divided doses.
16233772|NCT01133080|Drug|placebo|"placebo 200 mg/day orally in two divided doses for the first week. placebo 200 mg/day orally in two divided doses for the second week.
~From weeks 3 to weeks 5, placebo 400 mg/day orally in two divided doses."
16233776|NCT01133028|Behavioral|Behavioral contingency management|Teachers will learn to use reinforcements and response cost procedures to encourage children's display of prosocial behaviors.
16233777|NCT01133028|Behavioral|Tolerance training|Teachers will be instructed in procedures to encourage the peer group to be accepting of children with ADHD.
16233778|NCT01133015|Device|Fractional flow reserve|Fractional flow reserve measured by pressure wire
16233779|NCT01133015|Device|IVUS|intravascular ultrasound
16233780|NCT01132989|Drug|Lenalidomide|Lenalidomide Starting Dose Based on Renal Function at Study Entry Baseline Calculated Creatinine Clearance (by Cockcroft-Gault) Starting Lenalidomide Dose 60 ml/min 25mg daily on Days 1-21 of each 28-day cycle 30 and < 60 ml/min 10mg daily on Days 1-21 of each 28-day cycle
16233781|NCT01132976|Behavioral|Personal Concerns Inventory|This is a pre-treatment, goal-based motivational interview which helps to patients identify their life goals, and goal-value. The interview will last approximately 2 hours and will be carried out face to face with a therapist across one or two sessions.
16233782|NCT01132976|Behavioral|Treatment as usual|No specific motivational interview
16233783|NCT01132963|Other|Outdoor Shoes|Patient will be wearing sturdy outdoor shoes to complete balance tests
16233784|NCT01132963|Other|Pillow Paw Slippers|Patient will be wearing Pillow Paws slippers to complete balance tests which are issued to patients who do not have shoes in NHS hospitals in the UK
16233785|NCT01132950|Behavioral|Motivational Interviewing|Two personalized sessions of motivational interviewing. The first one is given while the participant is in jail and the second one is given at 3 months post release.
16233786|NCT01132950|Other|Didactic Educational Counseling|Participant will watch an educational video while in jail and a second educational video at 3 months post release.
16233787|NCT01132911|Drug|Vorinostat (SAHA)|
16233788|NCT01132911|Drug|Velcade (PS-341, Bortezomib)|
16233789|NCT01132846|Other|Placebo|Participants will be randomized to receive Low dose Dopamine or placebo plus optimal diuretic or Low dose Nesiritide or placebo plus optimal diuretic.
16233790|NCT01132846|Drug|Nesiritide|"Active Comparator: Low Dose Nesiritide
~Participants randomized to the low dose nesiritide arm will receive nesiritide of 0.005 ug/kg/min or placebo during the first 72 hours in the trial."
16233791|NCT01132846|Drug|Dopamine|Participants randomized to the low dose dopamine arm will receive dopamine of 2ug/kg/min or placebo during the first 72 hours in the trial.
16233792|NCT01132833|Other|enzyme-linked immunosorbent assay|Measurement of markers of coagulation and endothelial activation
16233793|NCT01132833|Other|laboratory biomarker analysis|The PPP will be used for in vitro assays to measure TF activity, coagulation markers and markers of endothelial cell damage
16233794|NCT01132833|Other|medical chart review|The patient's clinical course with respect to development of venous thromboembolism and response to treatment will be monitored for a total of 3 months from enrollment.
16233795|NCT01132820|Drug|Cediranib Maleate|Given PO
16233796|NCT01132820|Other|Laboratory Biomarker Analysis|Correlative studies
16233797|NCT01132807|Biological|Bleomycin Sulfate|Given IV
16233798|NCT01132807|Drug|Doxorubicin Hydrochloride|Given IV
16233799|NCT01132807|Drug|Procarbazine Hydrochloride|Given PO
16233800|NCT01132807|Drug|Vinblastine Sulfate|Given IV
16233801|NCT01132807|Drug|Dacarbazine|Given IV
16233802|NCT01132807|Drug|Cyclophosphamide|Given IV
16233803|NCT01132807|Drug|Etoposide phosphate|Given IV
16233804|NCT01132807|Drug|prednisone|Given PO
16233805|NCT01132807|Drug|Radiation Therapy|Undergo radiation therapy
16233806|NCT01132807|Radiation|Fludeoxyglucose F-18|Undergo FDG PET/CT
16233807|NCT01132807|Procedure|computed tomography|Undergo FDG PET/CT
16233808|NCT01132807|Procedure|Positron Emission Tomography|Undergo FDG PET/CT
16233809|NCT01132794|Drug|Intranasal dexmedetomidine|1mcg per kg dexmedetomidine given intranasally 45 minutes before operation
16233810|NCT01132794|Drug|Placebo|Intranasal nasal saline
16233811|NCT01132781|Drug|Theophylline (Intervention Group)|200 mg twice daily of slow release theophylline
16233812|NCT01132781|Drug|Placebo (Placebo Group)|200 mg twice daily of placebo drug
16233813|NCT01132768|Drug|Atenolol|Atenolol (ATE) 50 mg and/or 100 mg tablets, oral, once daily
16233814|NCT01132768|Drug|olmesartan medoxomil|Olmesartan medoxomil (OM), 20 mg and/or 40 mg, oral, once daily
16233815|NCT01132755|Procedure|Diagnostic peritoneal lavage|The Veress needle will be inserted in the abdominal wall, at a site to be left up to the individual surgeon. Caudal traction will be applied to the abdominal wall to provide a firm abdominal wall to insert the needle through, minimizing the peritoneum from tenting down closer to visceral structures. Intraperitoneal placement of the catheter will be confirmed by injection of saline into the needle with no resistance and with the saline in the hub of the needle falling into the peritoneal cavity spontaneously. A guide wire will be placed through the Veress and utilizing the Seldinger technique, a 9Fr peritoneal catheter will be placed.
16233816|NCT01132729|Drug|Valacyclovir Hydrochloride|1000 mg caplet
16233817|NCT01132716|Drug|Valacyclovir Hydrochloride|1000 mg caplet
16233818|NCT01132703|Drug|Glyburide for Injection|Administered as specified in the Treatment Arm.
16233819|NCT01132703|Drug|Placebo|Administered as specified in the Treatment Arm.
16233820|NCT01132690|Drug|Taliglucerase alfa|Taliglucerase alfa for infusion every two weeks for 12 months
16233821|NCT01132677|Device|Hylan G-F 20 (Synvisc One)|Single IA injection of 6cc's. Injections will be administered as outlined on the company label.
16233822|NCT01132677|Drug|Methylprednisolone (Corticosteroid)|Single IA injection of 80mg of methylprednisolone acetate (1cc of solution) mixed with 5cc's of 1% lidocaine without epinephrine for a total of 6cc's. The injection will be administered as outlined on the company label.
16233823|NCT01132664|Drug|BKM120|Buparlisib (BKM120) is the investigational drug. Burparlisib was supplied as 10 mg and 50 mg hard gelatin capsules. Buparlisib was dosed on a flat scale of mg/day and not adjusted to body weight or body surface area. Buparlisib capsules were packaged in high density polyethylene bottles with a plastic child resistant closure.
16233880|NCT01132313|Drug|BI 207127|16 weeks, standard dose, BID
16233881|NCT01132313|Drug|BI 201335|24 weeks, QD
16233882|NCT01132313|Drug|Ribavirin|48 weeks, according to label
16233824|NCT01132664|Drug|Trastuzumab|Trastuzumab was used in this study according to the local regulations in each participating country. A loading dose (4 mg/kg) of trastuzumab was administered (if required as assessed by the principal Investigator based on the timing of the last trastuzumab dose prior to enrollment) on Day -7 over 90 minutes, followed by weekly intravenous infusion of 2 mg/kg maintenance doses from Day 1 of Cycle 1 (over 30 minutes if the previous infusion was well tolerated).
16233825|NCT01132664|Drug|Capecitabine|1000 mg/m2 twice a day from day 1 to Day 14 of a 21-day cycle.
16233826|NCT01132651|Other|Current standard eczema treatment and standard pillow at night|Subjects will continue with their current eczema care and use their normal pillow at night.
16233827|NCT01132651|Other|Chillow cooling pillow|Subjects will use the cooling pillow to sleep on in addition to their current eczema treatment for 2 weeks.
16233828|NCT01132638|Drug|Magnesium Pantoprazole|1 capsule daily, 40 mg, orally, 30 minutes before breakfast
16233829|NCT01132638|Drug|Magnesium Esomeprazole|1 capsule daily, 40 mg, orally, 30 minutes before breakfast
16233830|NCT01132625|Drug|AUY922|
16233831|NCT01132612|Drug|AIN457|AIN457A 150 mg powder for solution
16233832|NCT01132612|Drug|Placebo|Placebo to AIN457A 150 mg powder for solution
16233833|NCT01132599|Dietary Supplement|C-11 choline|
16233834|NCT01132599|Radiation|18F-fluoromethylcholine|
16233835|NCT01132586|Drug|Lenalidomide|Given PO
16233836|NCT01132586|Drug|Cytarabine|Given IV
16233837|NCT01132586|Drug|Idarubicin|Given IV
16233838|NCT01132586|Other|Pharmacological Study|Correlative studies
16233839|NCT01132586|Other|Laboratory Biomarker Analysis|Correlative studies
16233840|NCT01132573|Drug|entinostat|Given PO
16233841|NCT01132573|Drug|clofarabine|Given IV
16233842|NCT01132573|Other|pharmacological study|Correlative studies
16233843|NCT01132573|Other|laboratory biomarker analysis|Correlative studies
16233844|NCT01132560|Genetic|RNA analysis|
16233845|NCT01132560|Genetic|gene expression analysis|
16233846|NCT01132560|Genetic|reverse transcriptase-polymerase chain reaction|
16233847|NCT01132560|Other|laboratory biomarker analysis|
16233848|NCT01132547|Drug|cyproheptadine hydrochloride|Given orally
16233849|NCT01132547|Other|placebo|Given orally
16233850|NCT01132521|Drug|ulinastatin|Resolved 4 vials of drugs in 100ml physiological saline solution, intravenously infused for 1-2h, tid, for continuous 7 days.
16233851|NCT01132521|Drug|placebo|Resolved 4 vials of drugs in 100ml physiological saline solution, intravenously infused for 1-2h, tid, for continuous 7 days.
16233852|NCT01132508|Device|Norian Drillable Bone Void Filler|Norian Drillable Bone Void Filler is a moldable, biocompatible bone void filler with added reinforcing fibers. Norian Drillable is intended to be placed into bony voids either before or after final fixation. The material can be drilled and tapped, and screws can be placed through it at any time during the setting process. Norian Drillable is a composite, two-component, self-setting calcium phosphate bone void filler
16233853|NCT01132495|Other|Stenting plus OMT|FFR guided PCI, plus OMT
16233854|NCT01132495|Other|OMT|OMT alone
16233855|NCT01132495|Other|Standard of care|FFR > 0.80; treatment according to local practice
16233856|NCT01132482|Drug|Sildenafil|During the course of the study, patients will receive 4 weeks of therapy: 28 days of placebo orally t.i.d. or 28 days of days of sildenafil orally t.i.d. Dosing of sildenafil will be escalated after the first week (20 mg orally t.i.d for the first week, then subjects will take 40 mg orally t.i.d. for 3 weeks). Patients not tolerating dose escalation will be discontinued from the study.
16233857|NCT01132482|Drug|Placebo|Patients receiving placebo will have sham dose escalation to maintain blinding.
16233858|NCT01132469|Procedure|Endoscopic Submucosal Dissection|5-years follow-up after Endoscopic Submucosal Dissection
16233859|NCT01132456|Device|Drug eluting stent treatment|Endeavor RESOLUTE Zotarolimus-Eluting Coronary Stent Implantation
16233860|NCT01132443|Drug|Clindamycin 1%-Benzoyl Peroxide (BPO) 3% Gel,|Apply topically once daily
16233861|NCT01132430|Behavioral|Motivational interviewing|Brief MI 3x30 minute sessions within 4-6 week period
16233862|NCT01132430|Behavioral|Usual care|Standard medical care within 4-6 week period
16233863|NCT01132417|Drug|In Vitro activity of Tigecycline among key bacterial pathogens exhibiting multidrug resistance|studies in human beings in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study.
16233864|NCT01132404|Drug|Leuprorelin|Phase 2 portion of study: patients randomized to this arm will receive a subcutaneous injection of depot Leuprorelin in the abdomen once per month for up to 6 months
16233865|NCT01132404|Drug|TAK-448|"Phase 1 portion of study:
~Patients will be administered a single dose of depot formulation TAK-448 via subcutaneous abdominal injection and a single dose of placebo at a contralateral injection site
~Phase 2 portion of the study:
~Patients randomized to this arm will be administered depot formulation TAK-448 (up to 2 dose levels) via subcutaneous injection in the abdomen once per month for up to 6 months"
16233866|NCT01132391|Drug|Rectogesic® (glyceryl trinitrate 0.4% ointment)|375 mg of ointment(1,5 mg of glyceryl trinitrate ) / 12h DURING 6 MONTHS
16233867|NCT01132378|Procedure|Total knee arthroplasty|staged bilateral total knee arthroplasty (not more than 7 days between surgeries)
16233868|NCT01132365|Device|any knee joint arthroplasty device|Cohort consist of all consented patients receiving knee arthroplasty
16233869|NCT01132352|Drug|Levetiracetam|Levetiracetam Tablets, 750 mg of Dr. Reddy's Laboratories Limited
16233870|NCT01132326|Drug|Droxidopa|Oral, 100, 200, 300, 400, 500, 600 mg TID, 12 months
16233871|NCT01132313|Drug|BI 207127|28 weeks, high dose, TID
16233872|NCT01132313|Drug|BI 201335|40 weeks, QD
16233873|NCT01132313|Drug|BI 207127|4 weeks, low dose TID
16233874|NCT01132313|Drug|BI 201335|24 weeks, QD
16233875|NCT01132313|Drug|Ribavirin|16 weeks, according to label
16233876|NCT01132313|Drug|Ribavirin|28 weeks, according to label
16233877|NCT01132313|Drug|Ribavirin|28 weeks, according to label
16233878|NCT01132313|Drug|BI 207127|40 weeks, high dose, TID
16233879|NCT01132313|Drug|BI 207127|24 weeks, very high dose, BID
16233888|NCT01132313|Drug|Ribavirin|24 weeks, according to label
16233889|NCT01132313|Drug|BI 201335|24 weeks, QD
16233890|NCT01132313|Drug|BI 201335|28 weeks, QD
16233891|NCT01132313|Drug|BI 207127|24 weeks, standard dose, BID
16233892|NCT01132313|Drug|BI 201335|24 weeks, QD
16233893|NCT01132313|Drug|BI 201335|16 weeks, QD
16233894|NCT01132313|Drug|BI 207127|16 weeks, high dose, BID
16233895|NCT01132313|Drug|BI 201335|24 weeks, QD
16233896|NCT01132313|Drug|Ribavirin|16 weeks, according to label
16233897|NCT01132313|Drug|Ribavirin|16 weeks, according to label
16233898|NCT01132313|Drug|BI 207217|28 weeks, high dose BID
16233899|NCT01132313|Drug|BI 201335|16 weeks, QD
16233900|NCT01132313|Drug|BI 207127|24 weeks, high dose, TID
16233901|NCT01132313|Drug|Ribavirin|48 weeks, according to label
16233902|NCT01132313|Drug|BI 207127|4 weeks, high dose, TID
16233903|NCT01132313|Drug|BI 201335|28 weeks, QD
16233904|NCT01132313|Drug|Ribavirin|24 weeks, according to label
16233905|NCT01132313|Drug|Ribavirin|24 weeks, according to label
16233906|NCT01132300|Device|Image Guided TENS (Auto-Targeted Neurostimulation, NeMa-st)|Patients will undergo 2 treatments per week during 4 weeks using the device. During the study Patients are allowed to maintain/continue taking medications/ analgesics for pain relief prescribed to them before the study. Medication use will be recorded.
16233907|NCT01132287|Other|FID 112903|lubricant eye drop FID 112903
16233908|NCT01132274|Procedure|Radiofrequency catheter ablation|Conventional radiofrequency catheter ablation through fluoroscopic guidance of supraventricular arrhythmias.
16233909|NCT01132274|Procedure|Radiofrequency catheter ablation|Radiofrequency catheter ablation through the non-fluoroscopic EnSite NavX mapping system (St.Jude Medical, St Paul, MN, USA) guidance.
16233910|NCT01132261|Other|"brain preservation' diet"|dietetic evaluation and advice in small group for health diet
16233911|NCT01132248|Drug|Mefloquine|15mg/kg mefloquine per dose Women receive two doses: One after the first trimester of pregnancy and the second at least one month after the first dose
16233912|NCT01132248|Drug|S/P|sulfadoxine-pyrimethamine IPTp will be administered following current WHO recommendations
16233913|NCT01132235|Biological|etanercept|50mgs subcutaneous injections twice a week for 12 weeks
16233914|NCT01132222|Drug|Ibuprofen + Pseudoephedrine Hydrochloride|Ibuprofen 200 mg + Pseudoephedrine Hydrochloride 30 mg Tablets
16233915|NCT01132209|Procedure|Closure of the abdominal wall after midline incisions|Closure of the midline incision after any abdominal operation. Suturing of the fascia of the abdominal wall with two different techniques
16233916|NCT01132196|Drug|Divalproex Sodium|Divalproex Sodium DR Tablets 500 mg
16233917|NCT01132183|Drug|Divalproex Sodium|Divalproex Sodium Coated Particles in Capsules, 125 mg of Dr. Reddy's Laboratories Limited
16233918|NCT01132170|Drug|Divalproex Sodium|Divalproex Sodium DR Tablets 500 mg
16233919|NCT01132157|Drug|Desflurane|In Desflurane group, donors and their recipients will be anesthetized with desflurane and remifentanil. In contrast, in Propofol group, donors will be anesthetized with Propofol and remifentanil and recipients will be anesthetized with desflurane and remifentanil.
16233920|NCT01132157|Drug|Propofol|In Desflurane group, donors and their recipients will be anesthetized with desflurane and remifentanil. In contrast, in Propofol group, donors will be anesthetized with Propofol and remifentanil and recipients will be anesthetized with desflurane and remifentanil.
16233921|NCT01132144|Procedure|Endometrial injury|"Evaluate the position and size of the uterus by transabdominal ultrasonography, with the bladder comfortably full.
~Identify the cervix with a disposable speculum. Open one sealed opaque envelope for allocation.
~Endometrial injury:
~Slide the Pipelle de Cornier® (Laboratoires Prodimed, Neully-En-Thelle, France) gently through the cervix up to the uterine fundus. Transbadominal ultrasound might be used to confirm position.
~Draw back the piston to the end of the biopsy cannula until it locks creating a negative pressure.
~Sweep the uterine fundus slowly several times up to the internal orifice of the cervix, using regular to-and-fro movements while rotating the sampler to include the whole uterine cavity in the specimen, for 30 seconds or until participant ask for stopping."
16233922|NCT01132144|Procedure|Control group|The investigator will dry the cervix with gauze and forceps for for 30 seconds or until participant ask for stopping.
16233923|NCT01132131|Other|Delegation form|The study aims to compare the use of a delegation form to identify patient's who qualify for antibiotic treatment for suspected acute cystitis with a regular doctor's consultation. The key outcomes are lack of bacteruria and symptoms of UTI at followup times.
16233924|NCT01132118|Drug|Hydroxychloroquine|Hydroxychloroquine comes in 200 mg tablets and is taken orally. The dose provided will be based upon a calculation of 6.5 mg/kg (subject's weight), which is the dose range commonly used to treat rheumatoid arthritis and lupus. Dosages will be rounded to the nearest 100 mg.
16233925|NCT01132105|Device|Vestibular myogenic evoked potential analyzer|
16233926|NCT01132079|Drug|cream treatment|
16233927|NCT01132066|Other|tDCS|tDCS will lead to an increase in cortical excitability
16233928|NCT01132066|Other|Sham|Sham will provide identical subjective sensation as tDCS
16233929|NCT01132040|Drug|Primidone|Primidone Tablets, USP 50 mg of Dr. Reddy's Laboratories Limited
16233930|NCT01132027|Drug|Tacrolimus Capsules|Tacrolimus Capsules, 5 mg of Dr. Reddy's Laboratories Limited
16233931|NCT01132014|Biological|OCDC|OCDC,an autologous vaccine comprised of autologous dendritic cells (DC) loaded in vitro with lysate from autologous oxidized tumor cells, administered intranodally alone, or in combination with either intravenous Daclizumab, or with a combination of Daclizumab and intravenous Bevacizumab.
16233932|NCT01131988|Drug|Tacrolimus Capsules|Tacrolimus Capsules, 5 mg of Dr. Reddy's Laboratories Limited
16233933|NCT01131975|Drug|Lamotrigine|Lamotrigine Tablets (chewable, dispersible), 25 mg
16233934|NCT01131962|Procedure|Endoscopic control of hematemesis|Endoscopy is performed to diagnose the cause of hematemesis and to control it using band ligation or sclerotherapy
16233935|NCT01131949|Drug|Lamotrigine|Lamotrigine Tablets (chewable, dispersible), 25 mg
16233936|NCT01131936|Drug|Amlodipine|Amlodipine Tablets, 10 mg
16233937|NCT01131923|Drug|Amlodipine|Amlodipine Tablets, 10 mg
16234200|NCT01129661|Biological|normal saline (0.9%)|Single intravenous dose of normal saline (0.9%)
16233938|NCT01131910|Biological|TBE-vaccine|Solution of 0.5 ml for intramuscular use. Given in 2 doses separated by 1 month to healthy individuals less than 60 years old. (3 doses 0+1+3 months to those are 60 and above in Sweden)
16233939|NCT01131910|Biological|TBE-vaccine|Solution for injection 0.5 ml im. 2 or 3 doses first years, 1 dose next year
16233940|NCT01131910|Biological|Vaccination against TBE|0.5 ml im at 0 and 1 month ( less than 60 years old) or 0 and 1 and 3 months (at least 60 years old)
16233941|NCT01131897|Drug|Levetiracetam|Levetiracetam Tablets, 750 mg of Dr. Reddy's Laboratories Limited
16233942|NCT01131884|Drug|Fosamax|70mg of Bisphosphonate therapy (Fosamax) will be taken weekly for a year
16233943|NCT01131884|Drug|Placebo|Placebo is an inactive pill that will look similar to the active drug. You will not know whether you are receiving active drug or placebo.
16233944|NCT01131871|Behavioral|Standard Behavioral Weight Loss Intervention|Subjects in this group will receive our standard behavioral weight control program that is delivered in an in-person group-based format. At month 7 subjects will also be given access to a study website to monitor eating and activity behaviors, and to have electronic access to standardized intervention materials. At month 7 subjects will also receive targeted study-related text messages that otherwise would have been provided in paper format.
16233945|NCT01131871|Behavioral|Enhanced Weight Loss Intervention|Subjects in this group will participate in a weight loss intervention that includes technology enhancements. These enhancements will include the addition of intervention specific targeted and tailored text messaging and the BodyMedia Fit System® beginning at Month 7. At month 7 subjects in EWLI will also receive the same targeted study-related text messages provided to SBWP that otherwise would have been provided in paper format.
16233946|NCT01131858|Drug|Vigantol|Vigantol 4000IU/day
16233947|NCT01131858|Drug|Placebo|Placebo
16233948|NCT01131845|Drug|UT-15C SR (treprostinil diethanolamine)|Single dose, 1 mg UT-15C SR
16233949|NCT01131832|Dietary Supplement|Plant sterol|
16233950|NCT01131832|Dietary Supplement|Placebo|
16233951|NCT01131819|Device|Nintendo Wii fit ™ balance board|Nintendo Wii fit ™ balance board will be introduced for a period of at least 20 minutes but not greater than 30 minutes per day to all the subjects for a minimum of 6 times in two weeks and a maximum of 18 times in 6 weeks.
16233952|NCT01131806|Drug|fluticasone/ salmeterol 125/25 mcg/puff|fluticasone 125mcg/salmeterol 25mcg 2puffs/day x 52 weeks
16233953|NCT01131806|Drug|fluticasone/ salmeterol 250/25 mcg/puff|fluticasone 250mcg/salmeterol 25mcg 2puffs/day x 52 weeks
16233954|NCT01131793|Device|PowerAssert RF wire in crossing coronary in-stent chronic total occlusions|Radio frequency ablation of chronic total occlusions within a stent of a coronary artery using Niobe Magnetic Navigation System (MNS) and the PowerAssert Radiofrequency Guidewire
16233955|NCT01131780|Drug|Ibuprofen + Pseudoephedrine Hydrochloride|Ibuprofen 200 mg + Pseudoephedrine Hydrochloride 30 mg Tablets
16233956|NCT01131767|Drug|Naproxen Sodium & Pseudoephedrine HCl|Naproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg Extended Release Tablets
16233957|NCT01131754|Other|heparin 100U/L flushes|peripheral venous catheter flushing with 3 mL of a 100 U heparin/mL normal saline from mono-use vial (Epsodilave, Mayne Pharma, Naples, Italy) at the end of each drug infusion. Independently from the number of drug infusions, all patients will receive at least two catheter flushes every day.
16233958|NCT01131741|Drug|Epinephrine|This group receives 3 mL of 1% lidocaine containing epinephrine IV during operation.
16233959|NCT01131741|Drug|Control|This group receives 3 mL of saline IV during operation.
16233960|NCT01131728|Drug|Naproxen Sodium & Pseudoephedrine HCl|Naproxen Sodium 220 mg and Pseudoephedrine Hydrochloride 120 mg Extended Release Tablets
16233961|NCT01131702|Drug|Ranitidine|Ranitidine Tablets, 300 mg
16233962|NCT01131689|Drug|sorafenib, TS-1|D1-14 S-1 dose of level 1/2/3/4 D1-21 Sorafenib 400mg twice daily Every 3 weeks-cycle
16233963|NCT01131676|Drug|BI 10773 low dose|BI 10773 tablets once daily
16233964|NCT01131676|Drug|Placebo BI 10773 high dose|Placebo tablets identical to BI 10773
16233965|NCT01131676|Drug|BI 10773 high dose|BI 10773 tablets once daily
16233966|NCT01131676|Drug|Placebo BI 10773 low dose|Placebo tablets identical to BI 10773
16233967|NCT01131676|Drug|Placebo BI 10773 low dose|Placebo tablets identical to BI 10773
16233968|NCT01131676|Drug|Placebo BI 10773 high dose|Placebo tablets identical to BI 10773
16233969|NCT01131637|Drug|rhNRG-1|day1~day10:0.6ug/kg/day,10hours per day for vein infusion; week3~week25:0.8ug/kg/day,10minutes per time per week for vein injection
16233970|NCT01131637|Drug|placebo|day1~day10:0.6ug/kg/day,10hours per day for vein infusion; week3~week25:0.8ug/kg/day,10minutes per time per week for vein injection
16233971|NCT01131624|Drug|ferrous sulphate|200 mg iron per day in a convenient dosage schedule.
16233972|NCT01131624|Drug|Ferinject|1000-1500mg diluted only in sterile 0.9% sodium chloride, The maximum single dose of FCM that can be administered by intravenous infusion is 20 mL (1,000 mg iron) but should not exceed 15 mg of iron per kg of body weight. This means that for subjects with a bw below 66 kg a maximal dose of 500 mg iron per infusion is allowed.
16233973|NCT01131611|Behavioral|CBPT|Cognitive-Behavioral Based Physical Therapy
16233974|NCT01131611|Other|Control-Attention|Standard of Care + weekly phone calls
16233975|NCT01131585|Procedure|Active laser photocoagulation|Active laser photocoagulation procedure at baseline and reapplied if needed at intervals no shorter than 3 months from the last treatment.
16233976|NCT01131585|Drug|Sham injections|Sham intravitreal injections at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.
16233977|NCT01131585|Drug|Ranibizumab 0.5 mg|Ranibizumab 0.5 mg/0.05 ml intravitreal injection at baseline, 30, 60 and 90 days and if needed, reapplied at intervals no shorter than 28 days from last treatment.
16233978|NCT01131572|Drug|N-acetylcysteine NAC|N-acetylcysteine in the treatment of Bulimia Nervosa
16233979|NCT01131559|Drug|Lisdexamfetamine|Oral; 20-70mg/day
16233980|NCT01131559|Drug|Placebo control|Oral; 20-70mg/day
16233981|NCT01131546|Drug|Levamlodipine besylate|Once daily, 7AM - 10AM
16233982|NCT01131546|Drug|Amlodipine maleate|Once daily, 7AM - 10AM
16233983|NCT01131533|Procedure|Vitrectomy|vitrectomy following intravitreal erythropoietin
16234201|NCT01129648|Drug|Placebo|Administered daily for 21 days
16233984|NCT01131520|Behavioral|Computerized brief intervention|This is a brief computerized intervention focused on drug use of patients receiving primary care treatment in an outpatient setting. The intervention is delivered in one session.
16233985|NCT01131520|Behavioral|Counselor delivered brief intervention|This is a one session brief intervention delivered in a primary care setting that is based on motivational interviewing.
16233986|NCT01131507|Drug|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] 3,000 lipase units delayed release capsules) from open capsules mixed with a small amount of apple juice or apple sauce will be administered orally starting at the same dose as administered at the end of study PR-011 (NCT01100606), with dose increments of 3,000 lipase units. The dose will be adjusted based on participants' age and body weight. Total dose will not exceed 10,000 lipase units per kilogram (kg) of body weight per day unless clinically indicated. Total duration of study treatment will be up to 12 months.
16233987|NCT01131494|Other|Motor exercises for swallowing, breathing and phonation|This exercises aimed to increase strength and range of motion of mouth, larynx and pharynx structures. All patients made sustained vowel phonation of /a/, pushing plosive phonemes /pa/, /ta/, /ka/ in a forceful manner, suction of wet gauze, swallowing with tongue hold and modified supraglottic maneuver, in ten repetitions, ascending and descending gliding phonation of vowel /a/ and /u/, five repetitions of each vowel, and tongue rotation in oral vestibule, 3 series of 5 repetitions to each side. Patients underwent oral motor exercises twice a day, five days a week, for five weeks.
16233988|NCT01131481|Device|Intraocular lens|
16233989|NCT01131468|Drug|N-acetylcysteine|N-acetylcysteine 600 mg twice daily or vancomycine+amikacin alone
16233990|NCT01131455|Biological|Autologous Concentrated Plasma|Autologous blood products have created a growing interest for use in a number of orthopedic therapies. The healing effects of plasma are supported by growth factors released by platelets. These growth factors induce a healing process wherever they are applied. The Arthrex ACP System is a cost-effective method of concentrating growth factors for therapeutic use.
16233991|NCT01131429|Drug|Erlotinib|Erlotinib 150 mg/d per os until proven disease progression
16233992|NCT01131429|Drug|Docetaxel|Docetaxel 75mg/m2 iv day 1 every 3 weeks as second-line treatment
16233993|NCT01131429|Drug|Cisplatin|cisplatin 75mg/ m2 iv day 1 every 3 weeks as second-line treatment
16233994|NCT01131429|Drug|Docetaxel|Docetaxel 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most
16233995|NCT01131429|Drug|Cisplatin|Cisplatin 75mg/m2 iv day 1 every 3 weeks for 6 cycles at most
16233996|NCT01131429|Drug|Erlotinib|Erlotinib 150 mg/d per os as second-line treatment
16233997|NCT01131416|Behavioral|Gum chewing|Gum chewing (30 minutes in duration each time, 4 times/days at the usual time of meal, until the first flatus) in addition to conventional postoperative feeding schedule
16233998|NCT01131390|Device|Ventilator setting changes|Ventilator settings will be changed every 3 minutes as described above, simultaneously measuring respiratory mechanics and patients' comfort.
16233999|NCT01131377|Drug|acetazolamide|"If ABGA is pH ≥ 7.43 & HCO3- ≥ 26mEq/L at 7am, they will receive acetazolamide 500mg via IV q 24h.
~If ABGA is pH ≤ 7.35 at 7am, acetazolamide will skip."
16234000|NCT01131377|Drug|Saline|They will receive saline 50ml via IV q 24h.
16234001|NCT01131364|Drug|F16IL2 in combination with doxorubicin|"Intravenous (i.v.) infusions of F16IL2 (Dose escalation: from 5 up to 25 MioIU) on days 1, 8, 15, 29, 36 and 43 over 60 minutes via automated device (perfusor), followed by a 30-minute i.v. infusion of doxorubicin (Dose escalation: from 20 up to 25 mg/m2) on Days 1, 8, 15 29, 36 and 43.
~Patients with objective tumor responses or stable disease will receive repeated cycles of treatment starting on Day 56. Patients will receive additional cycles of combination therapy for a maximum of 6 months, or until disease progression, unacceptable toxicity or withdrawal of consent."
16234002|NCT01131351|Drug|OPC-67683|Dosage-500-800 mg Strength 250-400 mg Frequency b.i.d.
16234003|NCT01131325|Drug|nilotinib|All patients will receive nilotinib 300mg bid po daily. Nilotinib dose is taken every 12 hours
16234004|NCT01131312|Device|Thinprep|Pap test
16234005|NCT01131312|Device|Hybrid capture 2|Human Papillomavirus (HPV) Deoxyribonucleic Acid (DNA) Test
16234006|NCT01131312|Procedure|Colposcopy|Procedure performed by a healthcare practitioner to examine the cervix, vagina, and vulva.
16234007|NCT01131299|Other|Placebo|2 tablets PO 3 times a day for 12-14 weeks
16234008|NCT01131299|Drug|Alpha cyclodextrin|2g PO 3 times a day for 12-14 weeks
16234009|NCT01131273|Drug|methadone|12 weeks of methadone maintenance with counseling
16234010|NCT01131273|Drug|buprenorphine-naloxone (Suboxone) for 12 weeks|12 weeks of maintenance with counseling
16234011|NCT01131260|Device|fetal STAN monitor|The STAN monitor is a system for fetal surveillance that displays the FHR, the uterine activity and information resulting from the analysis of the ST segment of the fetal ECG.
16234012|NCT01131247|Drug|ofatumumab + bendamustine|Loading dose of ofatumumab at 300mg IV with subsequent doses at 100mg IV on D1 of all cycles (maximum of 6 cycles) in combination with bendamustine 90mg/m2 on day 2 of all cycles. Neulasta 6mg SQ will also be given on day 8 of cycle 1 only.
16234013|NCT01131234|Drug|Gamma-Secretase Inhibitor RO4929097|Given PO
16234014|NCT01131234|Drug|Cediranib Maleate|Given PO
16234015|NCT01131234|Other|Pharmacological Study|Correlative studies
16234016|NCT01131234|Other|Laboratory Biomarker Analysis|Correlative studies
16234017|NCT01131221|Other|laboratory biomarker analysis|
16234018|NCT01131208|Genetic|gene expression analysis|
16234019|NCT01131208|Other|laboratory biomarker analysis|
16234020|NCT01131195|Biological|bevacizumab, Paclitaxel|Bevacizumab (10 mg/kg) i.v. is given every two weeks. Paclitaxel (90 mg/m2) i.v. is given on days 1, 8, and 15 of a 4 week cycle.
16234021|NCT01131195|Biological|Bevacizumab, Cyclophosphamide, Capecitabine|Bevacizumab (10 mg/kg) i.v. is given every two weeks. Cyclophosphamide (50 mg) and capecitabine (3x 500 mg) p.o. are given daily
16234022|NCT01131182|Drug|Sitagliptin phosphate|Sitagliptin 100 mg tablet administered orally once daily over the Ramadan period.
16234023|NCT01131182|Drug|Comparator: Sulfonylurea|Sulfonylurea (glibenclamide, glimepiride, or gliclazide) administered orally daily over the Ramadan period as per physician's prescription
16234024|NCT01131182|Drug|Metformin|Participants could continue pre-study metformin as concomitant therapy during the study.
16234202|NCT01129648|Drug|Allopurinol|Administered daily for 21 days.
16234025|NCT01131169|Drug|busulfan, melphalan and fludarabine|Patients will be cytoreduced with IV busulfan, melphalan and fludarabine. Busulfan will be administered at a dose of 0.8mg/Kg q6hrs for 10 doses on days -9, -8, -7. Doses for busulfan should be adjusted according to pharmacokinetic studies. Melphalan will be administered at a dose of 70 mg/m2/day for 2 days on days -7, -6. Fludarabine will be administered at a dose of 25 mg/m2/day for 5 days on days -6, -5, -4, -3, -2. Patients will also receive rabbit anti-thymocyte globulin (ATG) to prevent immune mediated graft rejection. The ATG will be administered at a dose of 2.5 mg/Kg/day IV on days -3 and -2. Doses for busulfan, melphalan and ATG should be adjusted if patient is > 125% ideal body weight and should be calculated on adjusted ideal body weight.
16234026|NCT01131169|Drug|busulfan, melphalan and fludarabine|Patients will be cytoreduced with IV busulfan, melphalan and fludarabine. Busulfan will be administered at a dose of 0.8mg/Kg q6hrs for 10 doses on days -9, -8, -7. Doses for busulfan should be adjusted according to pharmacokinetic studies. Melphalan will be administered at a dose of 70 mg/m2/day for 2 days on days -7, -6. Fludarabine will be administered at a dose of 25 mg/m2/day for 5 days on days -6, -5, -4, -3, -2. Patients will also receive rabbit anti-thymocyte globulin (ATG) to prevent immune mediated graft rejection. The ATG will be administered at a dose of 2.5 mg/Kg/day IV on days -3 and -2. Doses for busulfan, melphalan and ATG should be adjusted if patient is > 125% ideal body weight and should be calculated on adjusted ideal body weight.
16234027|NCT01131156|Behavioral|Smoking Relapse Prevention|Mothers were given information about normal newborn behaviors using books, DVDs, and handouts that were appropriate for their baby's gestational age and were also encouraged to participate in frequent skin-to-skin holding of their babies.
16234028|NCT01131143|Behavioral|Provider Voice|A phone call with the pre-recorded doctor's voice will be made to their patients who have been pre-screened for obesity before the patient's appointments prompting the patients to ask about physical activity, nutrition, and weight loss.
16234029|NCT01131143|Behavioral|Generic Voice|A phone call with a pre-recorded neutral voice will be made to the doctor's patients who have been prescreened for obesity before their patient's appointments. The call will prompt them to ask ask their doctor about physical activity, nutrition, and weight loss.
16234030|NCT01131130|Device|Investigational contact lens|After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.
16234031|NCT01131130|Device|Acuvue Oasys Contact Lens|After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.
16234032|NCT01131130|Device|Air Optix Aqua|After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.
16234033|NCT01131104|Drug|PDE5 Inhibitors|Observational study of participants who have been prescribed phosphodiesterase type 5 (PDE5) inhibitors by their physician during routine clinical practice.
16234034|NCT01131091|Drug|SK-0403|SK-0403 400 mg
16234035|NCT01131078|Drug|Bevacizumab [Avastin]|Bevacizumab was administered as a 7.5 mg/kg intravenous infusion over 30 to 90 minutes on Day 1 of each 3 week cycle.
16234036|NCT01131078|Drug|Capecitabine|Capecitabine was administered orally at a doses of 1000 or 1250, mg/m^2 twice daily (Day 2 to 15) or as 650 mg/m^2 twice daily on Days 1 to 21.
16234037|NCT01131078|Drug|Irinotecan|Irinotecan was administered as a 240 mg/m^2 intravenous infusion over 60 minutes (Day 1) every 3 weeks.
16234038|NCT01131065|Drug|Hepatitis B immune globulin|Daily doses of 10,000 IU of intravenous hepatitis B immune globulin during the first week post-transplantation (anhepatic phase + days 1-7), followed by weekly and monthly doses of 5,000 IU during weeks 2,3, and 4 and months 2,3,4,5,6,7,8,9,10,11 and 12, respectively.
16234039|NCT01131052|Drug|Insulin Glargine|glargine once a day
16234040|NCT01131052|Drug|Insulin|sliding scale regular insulin (SSRI) given before meals and at bedtime as needed
16234041|NCT01131052|Drug|Insulin glulisine|glulisine given as needed before meals
16234042|NCT01131039|Drug|Gemcitabine/Bevacizumab|"Gemcitabine: IV, days 1,8, and every 21 days
~Bevacizumab: IV, day 1 and every 21 days until disease progression"
16234043|NCT01131026|Drug|Levofloxacin|tablet, 500 mg, once a day for ten days
16234044|NCT01131026|Drug|Amoxicillin|tablet, 1000 mg, once a day for ten days
16234045|NCT01131026|Drug|Lansoprazole|capsule, 30 mg, twice a day for ten days
16234046|NCT01131013|Drug|Placebo|Matching placebo in capsules administered as a single oral dose.
16234047|NCT01131013|Drug|375 mg CK-2017357|375 mg CK-2017357 in capsules administered as a single oral dose.
16234048|NCT01131013|Drug|500 mg CK-2017357|500 mg CK-2017357 in capsules administered as a single oral dose.
16234049|NCT01131000|Drug|Ibuprofen|Intravenous ibuprofen, 100 mg, Single-dose
16234050|NCT01131000|Drug|Ibuprofen|Intravenous ibuprofen, 200mg, single dose
16234051|NCT01131000|Drug|Ibuprofen|Intravenous ibuprofen, 400 mg, Single-dose
16234052|NCT01131000|Other|Normal Saline|Normal Saline, 100 ml, Single-dose
16234053|NCT01130987|Other|Computerized handoff tool|Computer program that facilitates accurate transmission of patient information between residents
16234054|NCT01130987|Behavioral|Team training|Training in teamwork and reorganization of handoff processes to optimize transmission of information and team care
16234055|NCT01130974|Device|Bausch & Lomb contact lens|Bausch & Lomb daily disposable cosmetic tint contact lens
16234056|NCT01130974|Device|Marketed daily disposable contact lens|Marketed daily disposable cosmetic tint contact lens
16234057|NCT01130948|Other|altitude exposure|exposure to 490m, 1700m and 2590m
16234058|NCT01130922|Drug|moxifloxacin per IV|intravenous administration of 400 mg moxifloxacin (as a 1h-infusion)
16234059|NCT01130922|Drug|moxifloxacin per os|oral administration of 400 mg moxifloxacin in a single dose
16234060|NCT01130909|Drug|AZD6765|75 mg
16234061|NCT01130909|Drug|AZD6765|150 mg
16234062|NCT01130909|Drug|Ketamine|0.5 mg/kg
16234063|NCT01130909|Drug|Placebo|125 mL sterile NaCl 0.9%
16234064|NCT01130870|Device|Sensory Threshold|Sacral nerve stimulation with amplitude (sensory threshold), Frequency 14 Hz and pulse width 210 mic.sec.
16234065|NCT01130870|Device|75% of sensory threshold - Amplitude|Sacral nerve stimulation with amplitude (75% of sensory threshold), Frequency 14 Hz and pulse width 210 mic.sec.
16234203|NCT01129648|Drug|Allopurinol|Administered daily for 21 days.
16234066|NCT01130870|Device|50% of sensory threshold - Amplitude|Sacral nerve stimulation with amplitude (50% of sensory threshold), Frequency 14 Hz and pulse width 210 mic.sec.
16234067|NCT01130844|Drug|MMX Mesalamine|30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
16234068|NCT01130844|Drug|MMX Mesalamine|60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
16234069|NCT01130844|Drug|MMX Mesalamine|100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.
16234070|NCT01130831|Drug|Lanthanum carbonate|
16234071|NCT01130818|Drug|GLPG0492|single ascending doses, oral solution (25 to max. 120 mg/intake, 10 to 200 mg/mL)
16234072|NCT01130818|Drug|placebo|single dose, oral solution
16234073|NCT01130818|Drug|GLPG0492|single dose, solid formulation, 50 mg (2*25 mg/capsule), fasting
16234074|NCT01130818|Drug|GLPG0492|single dose, solid formulation, 50 mg (2*25 mg/capsule), after high fat breakfast
16234075|NCT01130805|Drug|Pazopanib in combination with capecitabine and oxaliplatin|Capecitabine 850 mg/m2 bid on day 1-14, Oxaliplatin 130 mg/m2 IV on day 1 and Pazopanib 800 mg once in a day on day 1-21, every 3 weeks
16234076|NCT01130792|Dietary Supplement|Lactobacillus GG|10 Billion Organisms Given Mixed In Milk As Food Supplement Once Daily For Four Weeks
16234077|NCT01130792|Dietary Supplement|Inulin|Identical appearing capsules containing a powder resembling the LGG to be given as for intervention
16234078|NCT01130779|Drug|Erlotinib (TARCEVA®)|Erlotinib 150mg/day, everyday
16234079|NCT01130766|Procedure|stereotactic radiosurgery (SRS)|Stereotactic radiosurgery using γ-rays from radioactive Cobalt-60 installed in Gamma Knife (Elekta Instruments, Stockholm, Sweden)
16234080|NCT01130753|Drug|Erlotinib|Erlotinib 150mg per day for 8 weeks
16234081|NCT01130740|Behavioral|Osteoarthritis Intervention|Primary care providers receive patient-specific osteoarthritis information and treatment recommendations two times (0 and 6 months); patients receive a 12-month intervention consisting of monthly phone calls focusing on exercise, weight management, and cognitive behavioral pain management.
16234082|NCT01130727|Other|green tea extract|1.21g of green tea extract (965 mg of flavonols)
16234083|NCT01130727|Other|cocoa extract rich in polyphenols|2.14 g of cocoa extract rich in polyphenols equivalent to 965 mg of polyphenols
16234084|NCT01130727|Other|placebo|placebo
16234085|NCT01130727|Other|low polyphenol cocoa extract|placebo
16234086|NCT01130714|Behavioral|Exercise|Resistance training with resistance bands.
16234087|NCT01130701|Other|Neoadjuvant capecitabine, panitumumab and radiation|"Patients will receive six weekly doses of panitumumab (2.5mg/kg) in conjunction oral capecitabine 825 mg/m2 PO bid Mon-Friday and external beam radiation therapy. Panitumumab and oral capecitabine will begin on the first week of external beam radiotherapy and will continue throughout the course of external beam radiation therapy, and will be discontinued following the conclusion of external beam radiation therapy.
~Patients will be reevaluated for surgical resection 4-6 weeks after completion of neoadjuvant therapy.
~After surgical resection, adjuvant systemic chemotherapy with gemcitabine for six months is strongly recommended for all patients."
16234088|NCT01130688|Drug|Zileuton|Imatinib combined with Zileuton
16234089|NCT01130675|Other|caffeinated coffee|8 oz. of caffeinated cofee/breakfast&noon meal. No intervention for 2nd arm.
16234090|NCT01130662|Drug|combination therapy using decitabine and midostaurin|"Cohort 1:
~Decitabine 20mg/m2 IV daily on days 1-5 to be repeated every 28 days. Midostaurin 25mg bid days 8-21 of each cycle.
~Cohort 2:
~Decitabine 20mg/m2 IV daily on days 1-5 to be repeated every 28 days. Midostaurin 50mg bid days 8-21 of each cycle.
~Cohort 3:
~Decitabine 20mg/m2 IV daily on days 1-5 to be repeated every 28 days. Midostaurin 50mg bid x 28 days of each cycle."
16234091|NCT01130649|Device|HealthBuddy|Noninvasive device for remotely reporting health information. The device does nothing to change the health of the patient, but transmits health data that is entered by the patient directly to the physician's office. Patients will enter data on seizure frequency, medication compliance, and side effects.
16234092|NCT01130636|Drug|Oseltamivir|Lactating women who present with clinical symptoms indicative of influenza will receive immediate treatment with oseltamivir (Tamiflu® 75 mg hard capsules) at a standard dose of 75 mg twice daily.
16234093|NCT01130623|Drug|Pazopanib (GW786034)|
16234094|NCT01130597|Drug|patiromer|Active investigational drug
16234095|NCT01130597|Drug|spironolactone|
16234096|NCT01130584|Other|Pyruvate kinase isoform M2|
16234097|NCT01130571|Procedure|Xenografts and cell cultures|
16234098|NCT01130558|Other|Diabetes Management|Using electronic insulin order template for basal-bolus insulin and education
16234099|NCT01130532|Drug|Tadalafil|Administer orally
16234100|NCT01130532|Drug|Placebo|Administer orally
16234103|NCT01130506|Drug|Cytarabine|Given IV
16234104|NCT01130506|Drug|Decitabine|Given IV
16234105|NCT01130506|Other|Laboratory Biomarker Analysis|Correlative studies
16234106|NCT01130506|Other|Pharmacological Study|Correlative studies
16234107|NCT01130506|Drug|Vorinostat|Given PO
16234108|NCT01130493|Drug|IPX066|experimental product
16234109|NCT01130493|Drug|CLE|active comparator
16234110|NCT01130480|Device|Accu-Chek Integra Glucometer|
16234111|NCT01130467|Drug|methylphenidate|IR-MPH were started on a dose of 5 mg tid po, and this was increased to 10 mg tid and then to 15 mg tid as necessary. OROS-MPH was started on a dose of 18 mg qd, and this was increased to 36 mg qd and then to 54 mg qd as necessary.
16234112|NCT01130467|Drug|Atomoxetine|Atomexetine was started (weight of 70 kg or less) 0.5 mg/kg/day orally and increased after a minimum of 3 days to a target dose of 1.2 mg/kg/day. The maximum dosage is 1.4 mg/kg/day or 100 mg/day (whichever is less).
16234113|NCT01130467|Behavioral|behavioral modification|Parenting and teaching skill education
16234114|NCT01130454|Device|Universal Electrophysiological Biofeedback Treatment|one 45 minute biofeedback treatment
16234115|NCT01130454|Device|Universal Electrophysiological Biofeedback Treatment|one 45 minute placebo treatment
16234116|NCT01130441|Behavioral|psychotherapy|short problem-solving skills therapy intervention
16234204|NCT01129648|Drug|Allopurinol|Administered daily for 21 days.
16234117|NCT01130428|Device|Juvent 1000 Vibration Platform|"As a mechanical intervention, mechanical stimulation in the form of vibration will be administered to the forearm using a Juvent 1000 Vibration Platform (Juvent Medical, Inc., Lakeland, FL, USA), which is a non-medicinal product. The device produces gentle, low-magnitude mechanical signals in the form of low-amplitude vertical displacements at a high frequency.
~The intervention in the present study will be given at a fixed dosage that is defined by the intensity of vibration: frequency: 90 Hz, amplitude: 10 µm (~3.0 g). The mechanical stimulation will be administered in an intermittent fashion, as it has been shown that inserting short rest periods between loading cycles enhances the efficacy of mechanical loading [38]. Thus, the mechanical stimulation will be administered for three times 10 minutes (i.e. the vibration platform turned on), with 10-minute rest periods in between (i.e. the vibration platform turned off); the intervention will have a total duration of 50 minutes."
16234118|NCT01130376|Biological|GTU-MultiHIV B clade vaccine1mg|Dose given is 1mg/ml administered as 10 intradermal injections of 100 µl/injection distributed as 5 intradermal injections /left and right arm
16234119|NCT01130376|Drug|Interleukin-2|5 Million Units administered twice daily for 5 days by subcutaneous injection on days 7, 8, 9, 10, and 11 after first vaccination. .
16234120|NCT01130376|Drug|GM-CSF|150 ug administered subcutaneously once daily 4 hours from IL-2 injections
16234121|NCT01130376|Drug|Growth Hormone|4mg/day will be self administered by Subcutaneous injection for 5 days on days 14, 15, 16, 17 and 18 following first vaccination
16234122|NCT01130337|Drug|Capecitabine [Xeloda]|1.000 mg/m2 orally every 12 hours from day 1 to day 14 of every cycle for 6 cycles
16234123|NCT01130337|Drug|Oxaliplatin|130 mg/m2 intravenous infusion day 1 of every cycle
16234124|NCT01130337|Drug|Trastuzumab [Herceptin]|First dose 8 mg/kg, subsequent cycles 6 mg/kg, intravenously, day of every cycle for 15 cycles
16234125|NCT01130324|Drug|VIBATIV|Observational
16234126|NCT01130311|Drug|Cholecalciferol|Intramuscular injection of 600,000 units of Cholecalciferol for 2 doses given at week 0 and week 4
16234127|NCT01130311|Drug|Saline injection|normal saline, intramuscular preperation,given in 2 doses at week 0 and week 4 of trial
16234128|NCT01130298|Drug|Testosterone Gel 1.62%|5 grams
16234129|NCT01130285|Genetic|Lung Cancer Risk Test|Measurement of gene expression in normal bronchial epithelial cells obtained at time of bronchoscopy.
16234130|NCT01130272|Drug|Eluxadoline|Tablets, orally, twice daily.
16234131|NCT01130272|Drug|Placebo|Matching placebo oral tablets twice daily.
16234132|NCT01130259|Drug|iniparib|5.6 mg/kg as a 60 (±10) minutes IV infusion. Administered on Days 1, 4, 8, and 11 of each 21 day cycle.
16234133|NCT01130246|Drug|A-002, varespladib methyl|A-002 administered once daily in addition to atorvastatin and standard of care
16234134|NCT01130246|Drug|Placebo|Placebo administered once daily in addition to atorvastatin and standard of care
16234135|NCT01130233|Procedure|robotic assisted rectal resection|robotic assisted rectal resection
16234136|NCT01130233|Procedure|laparoscopic rectal resection|laparoscopic rectal resection
16234137|NCT01130220|Other|Focus Group|"A single focus group will be held until a saturation of themes has been identified."
16234138|NCT01130194|Other|Combination of treatment modalities|"Intravenous cyclophosphamide, rituximab, and vincristine day 1 and 8 of 28 day cycles for 6 cycles total.
~Oral prednisone and procarbazine day 1-14 of every 28 day cycle. Yttrium ibritumomab tiuxetan intravenous injection. Autologous stem cell transplant with intravenous BEAM (BCNU or carmustine, etoposide, ara-C or cytarabine, melphalan) chemotherapy conditioning."
16234139|NCT01130181|Drug|Cholecalciferol|loading dose of 540,000 IU of cholecalciferol via feeding tube or orally, then 5 monthly doses of 90,000 IU
16234140|NCT01130181|Drug|Placebo|Matching placebo
16234141|NCT01130168|Drug|Placebo|Placebo, capsule taken orally once daily during 4 weeks of treatment
16234142|NCT01130168|Drug|Comparator: Amlodipine|Amlodipine 10 mg, taken orally as two 5 mg capsules, single daily dose for 4 weeks
16234143|NCT01130168|Drug|Comparator: ISMN ER|ISMN ER 30 mg capsule, taken orally as single daily dose for 4 weeks
16234144|NCT01130142|Drug|IPI-926 plus gemcitabine|Daily IPI-926 (oral) at 160 mg plus gemcitabine (infusion) at 1000 mg/m2 once weekly for 3 weeks of a 28 day cycle
16234145|NCT01130142|Drug|Placebo plus gemcitabine|Daily Oral placebo/IPI-926 160 mg plus gemcitabine infusion at 1000 mg/m2 once every 3 weeks in a 28 day cycle
16234146|NCT01130129|Other|Ex-vivo treatments with flavonoids|Ex-vivo treatment of platelets with a range of flavonoids
16234147|NCT01130103|Drug|Paroxetine|Paroxetine (controlled release) 12.5-50 milligrams (mg) daily for 22 weeks
16234148|NCT01130103|Behavioral|Prolonged Exposure Therapy|Weekly for 10 weeks
16234149|NCT01130090|Device|Adjustment of back-up respiratory rate on bi-level ventilator|"3 consecutive nights in randomized order, in either S (Spontaneous) mode, ST (Spontaneous/Timed) mode with a back-up rate under spontaneous respiratory rate of the patient, or in ST (Spontaneous/Timed) mode with a back-up rate at least 2 cycles/minute above spontaneous nocturnal respiratory rate. Each assessment will include complete polysomnographic recording (sleep study) as well as SpO2, PtcCO2, pneumotachograph (flow), mask pressure, quantitative assessment of patient-ventilator synchronisation, central or obstructive apnea and hypopnea, data of built-in software, and rating of patient comfort"
16234150|NCT01130077|Biological|HLA-A2 restricted glioma antigen peptides vaccine|Vaccine given every 3 weeks
16234151|NCT01130077|Biological|Poly-ICLC|Vaccine given every 3 weeks
16234152|NCT01130064|Biological|QAX576|every 3 weeks via intravenous infusion
16234153|NCT01130064|Drug|Placebo|every 3 weeks via intravenous infusion
16234154|NCT01130051|Drug|Colchicine 0.6 mg tablet|One Colcrys® 0.6 mg intact tablet taken by mouth
16234155|NCT01130051|Drug|Colchicine 0.6 mg tablet|One Colcrys® 0.6 mg tablet crushed and sprinkled on applesauce
16234156|NCT01130025|Drug|Warfarin|Tablets. Once daily for 6 months (180 days) to maintain therapeutic international normalised ratio (INR) levels in combination with initial (5-10 days) overlapping treatment with Innohep®.
16234157|NCT01130025|Drug|Innohep®|Solution for sub-cutaneous injection, pre-filled syringes. Once daily for 6 months (180 days). 175 anti Xa IU/kg.
16234158|NCT01130012|Behavioral|Lifestyle: diet and exercise|Lifestyle: The women received counseling by a clinical nutritionist six times and by a physiotherapist six times during pregnancy.
16234205|NCT01129648|Drug|BCX4208|Administered daily for 21 days.
16234159|NCT01130012|Behavioral|Close follow-up: reporting diaries of food and exercise|Follow-up: The women received information of the results of a glucose tolerance test (OGTT), reported food records three times during pregnancy, exercise history and exercise diaries monthly.
16234160|NCT01129999|Behavioral|Cognitive-Behavioral Therapy|a cognitive-behavioral smoking cessation program; 6, weekly-held, group sessions (90 min each)
16234161|NCT01129999|Behavioral|Hypnotherapy|hypnotherapeutic smoking cessation program; 6, weekly-held, group sessions (90 min each)
16234162|NCT01129986|Device|DermaStream|Five treatment days. On each day DermaStream application for up to 4 hours of saline streaming.
16234163|NCT01129960|Drug|Eslicarbazepine acetate (BIA 2-093)|Tablets will be used.
16234164|NCT01129960|Drug|Placebo|Tablets will be used.
16234165|NCT01129947|Drug|DHEA|DHEA 25 mg tid
16234166|NCT01129934|Drug|Morphine-Promethazine|administration of intravenous morphine 0.1mg/kg and promethazine 12.5 mg in a 500 Ml 0.9% saline
16234167|NCT01129934|Drug|morphine|Administration of intravenous morphine 0.1 mg/kg
16234168|NCT01129921|Device|Percutaneous Lumbar Decompression|Fluoroscopic percutaneous lumbar decompression of the central spinal canal
16234169|NCT01129921|Device|Sham lumbar decompression|Sham fluoroscopic percutaneous lumbar decompression with no bone or tissue removal.
16234170|NCT01129895|Behavioral|Health promotion|In each intervention clinic 5 workshops on the initiation of health prevention projects in each clinic will be organized by the intervention team and than the clinic will be followed by the intervention team for 6 months.
16234171|NCT01129882|Drug|Aripiprazole|Aripiprazole IM depot - 300 mg or 400 mg
16234172|NCT01129856|Drug|Dexamethasone phosphate ophthalmic solution|Transscleral iontophoresis delivery of EGP-437 (dexamethasone phosphate formulated for ocular iontophoresis)
16234173|NCT01129856|Drug|Sodium citrate buffer solution|Sodium citrate buffer solution 100 mM
16234174|NCT01129843|Drug|Directly observed home based daily iron therapy|Directly Observed Home based Daily Iron( ferrous sulphate) therapy (DOHBIT) will be provided to the anemic women by the local village volunteers. Dose of elemental iron therapy will be 100 mg once daily for mild to moderate anemia and twice daily for severe anemia for a cumulative duration of 90 days
16234175|NCT01129830|Dietary Supplement|dehydroepiandrosterone|DHEA supplementation 25 mg tid for 3 months
16234176|NCT01129817|Other|Cognitive Functional Therapy|A novel multidimensional classification system has been developed incorporating the biopsychosocial model, which subgroups patients based on their presentation with matched interventions directed at the maladaptive cognitive, physical and lifestyle behaviours associated with the disorder. The intervention is called 'cognitive functional therapy' as it directly challenges these behaviours in a functionally specific and graduated manner.
16234177|NCT01129817|Other|Manual therapy and exercise|Patients in this group was treated with joint mobilization or manipulation techniques applied to the spine or pelvis primarily and was designed to be consistent with best current manual therapy practice in Norway. The particular dose and techniques were at the discretion of the treating therapist, based on each participant's objective and physical examination findings. In addition most of the patients in this group was given exercises or a home exercise program.
16234178|NCT01129804|Behavioral|Coping Skills Training|Patients in both treatments will be taught skills to help them keep from drinking.
16234179|NCT01129791|Behavioral|Raw Milk|Organic whole raw cow's milk, consumed daily in one sitting, at incremental doses from 4 to 24 oz. for 8 days. After a 1-week wash-out period, pasteurized cow's milk or non-dairy milk were consumed in the same fashion for another 8 days each.
16234180|NCT01129791|Behavioral|Pasteurized Milk|Organic whole pasteurized cow's milk, consumed daily in one sitting, at incremental doses from 4 to 24 oz. After a 1-week wash-out period, raw cow's milk or non-dairy milk were consumed in the same fashion for another 8 days each.
16234181|NCT01129791|Behavioral|Non-dairy milk|Unflavored soy milk, consumed daily in one sitting, at incremental doses from 4 to 24 oz. After a 1-week wash-out period, raw cow's milk or pasteurized cow's milk were consumed in the same fashion for another 8 days each.
16234182|NCT01129778|Drug|Zegerid (proton pump inhibitor)|
16234183|NCT01129778|Procedure|Bravo pH monitoring|
16234184|NCT01129765|Device|Use of an automatic nasal irrigator/aspirator|After reading the device's user manual, parents were asked to use it on their congested children to their satisfaction. During this time, a clinical observer recorded predetermined steps that needed to be performed for success as well as presence of any adverse events.
16234185|NCT01129752|Other|No intervention|there is no intervention for this study
16234186|NCT01129739|Other|Human umbilical cord-derived MSCs|1.0E+6 MSC/kg, IV drop and repeat to apply in trimonthly for 2 cycle
16234187|NCT01129739|Other|cyclosporine A (CsA)|CsA 5mg/kg po for 6 months
16234188|NCT01129726|Device|Transillumination-guided Fiberoptic Intubation|Light guided, Non-invasive
16234189|NCT01129713|Drug|Secretol|Comparing 80/80 once daily to Nexium once daily in healing erosive esophagitis.
16234190|NCT01129713|Drug|Nexium|Comparing 40 mg Nexium once daily to 80/80 Secretol once daily in healing erosive esophagitis.
16234191|NCT01129700|Radiation|Radiation: short-course preoperative chemoradiotherapy|"Drug: 5-Fluorouracil 5-Fluorouracil is administered intravenously at a dose of 400 mg/m2 once daily continuous regimen during RT(5 days).
~Radiation: Localization, simulation and immobilization Radiation dose and planning Total dose 25Gy, 5 fractions (5 Gy/day)."
16234192|NCT01129687|Procedure|Microsurgery|Patient would under to total, near-total, or subtotal resection of tumor
16234193|NCT01129687|Procedure|Stereotactic radiation therapy|Patient who has sign of growth of tumor remnant would undergo this treatment
16234194|NCT01129674|Drug|LY2140023|Administered orally, twice daily for 104 weeks
16234195|NCT01129674|Drug|Olanzapine|Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks
16234196|NCT01129674|Drug|Aripiprazole|Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks
16234197|NCT01129674|Drug|Risperidone|Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks
16234198|NCT01129674|Drug|Quetiapine|Tablets or capsules, given orally, consistent with approved labeling and local practice for 104 weeks
16234199|NCT01129661|Biological|CSL112 (reconstituted HDL)|Single escalating intravenous doses of CSL112
16234206|NCT01129648|Drug|Allopurinol|Administered daily for 21 days.
16234207|NCT01129648|Drug|Allopurinol|Administered daily for 21 days.
16234208|NCT01129648|Drug|Allopurinol|Administered daily for 21 days.
16234209|NCT01129648|Drug|BCX4208|Administered daily for 21 days.
16234210|NCT01129648|Drug|Allopurinol|Administered daily for 21 days.
16234211|NCT01129648|Drug|Allopurinol|Administered daily for 21 days.
16234212|NCT01129648|Drug|Allopurinol|Administered daily for 21 days.
16234213|NCT01129648|Drug|BCX4208|Administered daily for 21 days.
16234214|NCT01129648|Drug|Allopurinol|Administered daily for 21 days.
16234215|NCT01129648|Drug|Allopurinol|Administered daily for 21 days.
16234216|NCT01129648|Drug|Allopurinol|Administered daily for 21 days.
16234217|NCT01129648|Drug|BCX4208|Adminstered daily for 21 days
16234218|NCT01129635|Procedure|Cardiac Resynchronization Therapy (CRT) implantation|"The impedance measurement is performed during device implantation following CMR. After the RV and LV leads are inserted, secured and tested, they will be connected to the impedance monitor. Impedance recording of at least ten beats will be acquired and stored for future analysis. Each recording will be tagged with the anatomical location of the LV lead. Subsequently, the LV lead will be moved to a different location and the same procedure will be repeated until accessible coronary sinus sites are exhausted. The ultimate LV lead location is determined by the implanting electrophysiologist and is not constrained by the study protocol. Finally, the LV lead will be tested again and the rest of the implantation procedure will proceed as routine.
~Arm: CRT Candidate"
16234219|NCT01129622|Drug|letrozole|Letrozole (12.5 mg/day ) which is higher than the dose routinely used for therapeutic indications is given for a brief duration (3 successive days) aiming to promote acute aromatase inhibition suitable for pre-diagnostic regimens.
16234221|NCT01129596|Drug|donepezil hydrochloride|This is a multicenter, open-labeled, practice-based, post-marketing surveillance study. Therefore, dosing is not specified.
16234222|NCT01129583|Drug|Botulinum Toxin Type A|Injection into the biceps brachii and brachialis immediately following the initial fracture surgery
16234223|NCT01129583|Drug|Saline|Injection into the biceps brachii and brachialis immediately following the initial fracture surgery
16234224|NCT01129570|Drug|Silybin|4 dose levels of siliphos: 2, 4, 8, and 12 grams daily in three divided doses. This study will follow a standard sequential Phase I dose escalation design.
16234225|NCT01129557|Drug|Aliskiren|
16234226|NCT01129557|Drug|Valsartan|
16234227|NCT01129544|Biological|Gene transfer|Three procedures: 1) Bone marrow harvest from the patient's posterior iliac crests. 2.) Chemotherapy conditioning with Busulfan 3)One time infusion of patient's transduced bone marrow cells.
16234228|NCT01129531|Drug|AGN-214868|AGN-214868 injected into areas of postherpetic neuralgia pain for total dose per treatment.
16234229|NCT01129531|Drug|Placebo to AGN-214868|Placebo to AGN-214868 injected into areas of postherpetic neuralgia pain per treatment.
16234230|NCT01129518|Biological|Glyco-conjugate Neisseria meningitidis serogroup C (MenC) vaccine|"In order to ensure proper intramuscular injection of the study vaccines, a 23G (0.5mm in diameter) needle of at least 1 inch (2.54 cm) length will be used. All vaccines will be administered intramuscularly.
~Then MenC vaccine will administered either once (at 3 months) or twice (at 3 and 4 months) depending on treatment group to either the thigh, deltoid or a combination of the two."
16234231|NCT01129518|Biological|Routine schedule immunisations except monovalent MenC vaccine|Routine schedule immunisations will be given according to NHS guidelines.
16234232|NCT01129505|Behavioral|Nutrition & Exercise Lifestyle Intervention Program (NELIP)|"Nutrition- individualize total energy intake with a minimum of 2000 kcal/day with a restriction of not more than 33% total energy intake, total carbohydrate of 40-50% total energy intake, total fat intake of 30% of total energy intake (substituting monounsaturated fatty acids for saturated and trans-fatty acids), and approximately 30% dedicated to protein intake.
~Exercise-25 minutes of walking per session, 3-4 times per week, each subsequent week increasing by 2 mins to a maximum of 40 mins/session.
~Family-based Behavioural Treatment (FBBT) Coupled with the individualized NELIP for each woman, FBBT will be presented in 3 group sessions (including family members), focussing on strategies to make healthy lifestyle choices with behavioural strategies."
16234233|NCT01129492|Device|Low-level Laser therapy|A continuous wave (CW) diode laser device (830nm, infrared) with a beam area of 0.2827cm2 and using the punctual method, continuous emission mode, output power of de 50mW and fluence of 70J/cm2 (40 seconds at the point of application).
16234234|NCT01129479|Drug|Galantamine|Galantamine XL 8 mg for 4 weeks, followed by Galantamine XL 16 mg for subsequent 12 weeks. Taken in the morning with food for total of 12 weeks.
16234235|NCT01129479|Drug|Placebo pill|Placebo pill each morning with food for 12 weeks.
16234236|NCT01129466|Dietary Supplement|Supplement A followed by Supplement B|Supplement A (3 days of Broccosprout homogenate) will be followed at least 2 weeks later by Supplement B (3 days of Broccosprout sandwich and SFN rich tea)
16234237|NCT01129466|Dietary Supplement|Supplement B followed by Supplement A|Supplement B (Broccosprout sandwich and SFN rich tea for 3 days) followed at least 2 weeks later by 3 days of Supplement A (Broccosprout homogenate)
16234238|NCT01129453|Biological|CVD 1902, a Salmonella enterica Serovar Paratyphi A live, oral vaccine|CVD 1902 consists of ΔguaBA, ΔclpX Salmonella enterica serovar Paratyphi A vaccine strain diluted in sterile phosphate buffered saline to achieve the desired inoculum. Form: liquid. Dose: 10^6, 10^7, 10^8, or 10^9 CFU per mL. Route: oral.
16234239|NCT01129453|Other|Placebo|30 ml of buffer solution (2.0 grams of NaHCO3 dissolved in 150 ml of sterile water) without bacteria, to which food grade corn starch, USP is added, as necessary, to match the turbidity of the vaccine inoculum
16234240|NCT01129440|Device|Fluoride Varnish|Topical application of 0.25mL of fluoride varnish on each dental arch (upper and lower) at baseline and every 6 months.
16234241|NCT01129440|Device|Glass Ionomer Sealant|"Fluoroaluminosilicate glass powder and polyacrylic acid liquid are mixed together in a capsule to form the glass ionomer sealant material.
~After toothbrushing and conditioning dental surfaces with 20% polyacrylic acid for 10 seconds, pink-colored fluoride releasing glass ionomer dispensed from a capsule is applied to the occlusal (biting) surface of the molar."
16234242|NCT01129427|Drug|Clopidogrel|"Pharmaceutical form: tablet
~Route of administration: oral"
16234243|NCT01129427|Drug|Placebo|"Pharmaceutical form: matching tablet
~Route of administration: oral"
16234244|NCT01129427|Drug|Pantoprazole|"Pharmaceutical form: delayed-release tablet
~Route of administration: oral"
16234245|NCT01129414|Drug|Clopidogrel|"Pharmaceutical form: tablet
~Route of administration: oral"
16234246|NCT01129414|Drug|Placebo|"Pharmaceutical form: matching tablet
~Route of administration: oral"
16234247|NCT01129414|Drug|Omeprazole|"Pharmaceutical form: delayed-release capsule
~Route of administration: oral"
16234248|NCT01129401|Behavioral|Stonewall Project|The Stonewall Project is an outpatient substance abuse treatment program for methamphetamine-using MSM that includes individual counseling, group counseling, and visits with a psychiatrists where indicated.
16234249|NCT01129388|Drug|clopidogrel|"Pharmaceutical form: tablet
~Route of administration: oral"
16234250|NCT01129388|Drug|Placebo|"Pharmaceutical form: matching tablet
~Route of administration: oral"
16234251|NCT01129388|Drug|omeprazole|"Pharmaceutical form: delayed-release capsule
~Route of administration:oral"
16234252|NCT01129375|Drug|clopidogrel|"Pharmaceutical form: tablet
~Route of administration: oral"
16234253|NCT01129375|Drug|placebo|"Pharmaceutical form: matching tablet
~Route of administration: oral"
16234254|NCT01129375|Drug|omeprazole|"Pharmaceutical form: delayed-release capsule
~Route of administration:oral"
16234255|NCT01129362|Biological|Pentacel® (DTaP-IPV/Hib)|0.5 mL dose, Intramuscular
16234256|NCT01129362|Biological|Other Pertussis Vaccines|0.5 mL, Intramuscular
16234257|NCT01129349|Drug|Oprozomib|Oral administration of Oprozomib on Days 1-5 of a 14 day cycle
16234258|NCT01129336|Drug|Zoledronic acid|Patients with no bone metastasis (n=150) will receive Standard therapy plus Zoledronic acid administration 4 mg IV monthly during Months 1-18.
16234259|NCT01129336|Drug|Standard Therapy|Standard Therapy, including chemotherapy and hormonal therapy, was determined at the discretion of the investigator.
16234260|NCT01129323|Drug|Cyclophosphamide, Fludarabine, Rabbit ATG|Fludarabine 30mg/m2/dose IV and cyclophosphamide 10mg/kg/dose IV are given once per day from day -5 to -2. rATG 1.5 mg/kg/dose IV is given from day -4 to -1.
16234261|NCT01129310|Drug|Irinotecan-Capecitabine-Oxaliplatin|Irinotecan-160mg/m2 IV infusion over 60-90 min on Day 1 Capecitabine-1900mg/m2 daily PO in divided doses (=950mg/m2 BID) on days 2-15 Oxaliplatin- 100mg/m2 IV infusion over 2 hours Day 1
16234262|NCT01129284|Drug|ACTHAR gel|Patients will be treated with ACTHAR gel starting with 40 units given twice weekly subcutaneously for two weeks, then 80 units given twice weekly subcutaneously afterwards for a period of up to six months.
16234263|NCT01129271|Drug|clopidogrel|"Pharmaceutical form: tablet
~Route of administration: oral"
16234264|NCT01129271|Drug|Matching placebo|"Pharmaceutical form: tablet
~Route of administration: oral"
16234265|NCT01129258|Drug|PF-04991532|Subjects will be dosed wtih PF-04991532 for 14 days. The tentative dosing schedule is 30, 100, 300, 1000, and 1500 mg QD, and 150 and 500 mg BID). Doses shown may be adjusted upwards or downwards and may be adjusted to include intermediate doses. All doses will be administered as tablets (10, 50, and 150 mg strengths). In each cohort 9 subjects will receive PF-04991532 and 3 will receive placebo.
16234266|NCT01129258|Drug|Placebo|Placebo to match PF-04991532 will be provided. Subjects will be dosed for 14 days. In each cohort 9 subjects will receive PF-04991532 and 3 will receive placebo.
16234267|NCT01129245|Drug|Celebrex|400 mg PO daily intermittently based on hormone and ultrasound findings
16234268|NCT01129245|Drug|Placebo|Placebo identical to celecoxib
16234269|NCT01129232|Drug|GAD-alum|20 µg of GAD-alum injected sc after the biopsy, and repeated after one month
16234270|NCT01129232|Other|Placebo|Placebo injected after the biopsy and repeated after one month (similar to the GAD-alum-arm)
16234271|NCT01129219|Other|Strength training|Strength training for 24 weeks
16234272|NCT01129206|Drug|pralatrexate|IVP(intravenous push)over 3-5 minutes on day 1 at a dose of 120 mg/m2.
16234273|NCT01129206|Drug|docetaxel|Given Intravenous Piggyback (IVPB)as one-hour infusion at a dose of 3 mg/m2 on day 1 of a cycle. cycle defined as 14 days.
16234274|NCT01129206|Radiation|fludeoxyglucose F 18|Correlative studies
16234275|NCT01129206|Procedure|positron emission tomography|Correlative studies
16234276|NCT01129193|Other|Pharmacodynamic Studies|"Assess at baseline (pre-dose day 1 of cycle 1), approximately 24 hours after the first dose, pre-dose days 2 and 3, and pre-dose day 19 for histone acetylation of tumor cells (CLL patients) or mononuclear cells (PBMCs for lymphoma, myeloma, and solid tumor patients).
~Cytokine studies will be collected pre-dose on days 1, 2, 8, 15, 19 of cycle 1, day 1 of cycle 2, and pre-dose days 1, 8, 15 of cycle 3."
16234277|NCT01129193|Other|Fatigue Inventory|Brief Fatigue Inventory should take each patient approximately 5 minutes to fill out this survey per instance on day 1 of every cycle.
16234278|NCT01129193|Other|Pharmacogenomic studies|Baseline germ line DNA from buccal swabs will be collected for analysis of drug (AR-42) metabolism SNPs and other biologic SNPs that might predict immune or disease response to therapy. Pharmacogenetic status of key metabolizing enzymes (eg, CYP3A5, UGT1A8) and transporter proteins (SLCO1B1, ABCG2) will also be considered for their role in drug clearance in individual patients.
16234279|NCT01129193|Drug|AR-42|Administered orally three times per week (Mon, Wed, and Fri preferred) in cycles of 28 days (3 weeks of 3-times-per-week dosing followed by a 7-day off-treatment period).
16234280|NCT01129180|Drug|azacitidine|Given SC
16234281|NCT01129180|Drug|bortezomib|Given IV
16234282|NCT01129180|Procedure|Correlative studies|Correlative studies will be collected pre-treatment, day 4 , day 15, day 29(pre-cycle 2)
16234283|NCT01129154|Drug|infusions of Panitumumab|Patients will receive six infusions of Panitumumab 6 mg/kg every 2 weeks or until progression if earlier.
16234284|NCT01129141|Procedure|Tele-PTM|Telephone-based Progressive Tinnitus Management (Tele-PTM) is a novel home-based telehealth program that involves a series of seven telephone appointments, conducted at approximately 1, 2, 3, 4, and 5 weeks, and 3 and 6 months after enrollment is finalized. Telephone education was provided by the Study Psychologist at weeks 1, 3, and 5, and month 6; and by the Study Audiologist at weeks 2 and 4, and month 3.
16234337|NCT01128816|Device|Adaptive Servo Ventilation|BiPAP autoSV ADVANCED device worn nightly during sleep
16234404|NCT01128335|Drug|sotrastaurin (300 mg bid) + tacrolimus + standard of care medications|sotrastaurin (300 mg bid) + tacrolimus + standard of care medications
16234285|NCT01129141|Procedure|Wait List Control|Wait List Control subjects received Tele-PTM after completing the 6-month questionnaires. Participants assigned to Wait List Control were instructed that they could receive any available tinnitus services, and that they would receive Tele-PTM following completion of the 3- and 6-month questionnaires.
16234286|NCT01129128|Biological|Echinacea purpurea product|5 ml by mouth 3 times per day for 10 days
16234287|NCT01129128|Biological|Echinacea purpurea product|1 ml by mouth 3 times per day for 10 days
16234288|NCT01129128|Biological|Placebo|either 5 ml or 1 ml by mouth three times per day for 10 days
16234289|NCT01129115|Behavioral|Nonexercise control group|Participants randomized to the nonexercise control group will be asked to maintain their current level of physical activity during the 26-week active study period. They will perform outcome assessments and receive the same telephone checks as the exercise group at baseline, 26 and 52 weeks. The purpose of including a non-exercise control group is to allow adequate comparisons with the low, medium and high exercise dose groups on changes in cognitive and physiologic outcome measures.
16234290|NCT01129115|Behavioral|Aerobic Exercise Group 1|The 50% group will perform 75 minutes a week of moderate intensity exercise spread over 3 days.
16234291|NCT01129115|Behavioral|Aerobic Exercise Group 2|The 100% group will perform 150 minutes a week of exercise over 3 - 5 days
16234292|NCT01129115|Behavioral|Aerobic Exercise Group 3|The 150% group will perform 225 minutes a week of exercise over 4 - 5 days.
16234293|NCT01129102|Drug|NPC-01|Norethisterone 1mg, Ethinyl estradiol 0.02mg
16234294|NCT01129102|Drug|IKH-01|Norethisterone 1mg, Ethinyl estradiol 0.035mg
16234295|NCT01129102|Drug|Placebo|Placebo for NPC-01
16234296|NCT01129089|Dietary Supplement|Lipid-based nutrient supplement|Lipid-based nutrient supplement for pregnant and lactating women
16234297|NCT01129089|Dietary Supplement|Lipid-based nutrient supplement|Lipid-based nutrient supplement for infant and young children
16234298|NCT01129089|Dietary Supplement|Micronutrient powder|Micronutrient powder for infant and young children
16234299|NCT01129063|Drug|Clopidogrel|"Pharmaceutical form : tablet
~Route of administration: oral"
16234300|NCT01129050|Dietary Supplement|Fish Oil|Fish oil capsule
16234301|NCT01129050|Dietary Supplement|Flaxseed Oil|Flaxseed oil capsule
16234302|NCT01129050|Dietary Supplement|Placebo|Soybean oil capsule
16234303|NCT01129037|Other|Goal directed fluid management based on continuous monitoring of stroke volume|Baseline SV measurement, repeated volume loading (VL) with aliquots of 250 ml HES until SV increased < 10% in response to receding VL: SV is optimized, no further VL required.
16234304|NCT01129024|Drug|Lusutrombopag|tablet
16234305|NCT01129011|Drug|PN400 (VIMOVO)|PN400 tablets (Naproxen 500 mg and Esomeprazole 20 mg) twice daily (bid) taken orally.
16234306|NCT01129011|Drug|Naproxen|Naproxen 500 mg dosed twice daily (bid) orally
16234307|NCT01128998|Drug|Sorafenib|"Name: Sorafenib
~Dosage form: 200 mg / Tablet
~Dosing schedule: 200 mg bid, po, everyday, since Day 8 of Cycle 1"
16234308|NCT01128998|Drug|S-1|"Name:S-1
~Dosage form: 20 mg or 25 mg / Capsule
~Dosing schedule: 20-40 mg/m2 bid,po, 14 days on & 7 days off"
16234309|NCT01128985|Drug|Canagliflozin 50 mg|50 mg capsule once daily for 7 consecutive days from Day 1 to Day 7
16234310|NCT01128985|Drug|Canagliflozin 100 mg|100 mg capsule once daily for 7 consecutive days from Day 1 to Day 7
16234311|NCT01128985|Drug|Canagliflozin 300 mg|300 mg capsule once daily for 7 consecutive days from Day 1 to Day 7.
16234312|NCT01128985|Drug|Placebo|matching canagliflozin placebo once daily for 7 consecutive days from Day 1 to Day 7
16234313|NCT01128972|Drug|Sodium fluoride|Test fluoride toothpaste and test fluoride mouth rinse
16234314|NCT01128972|Drug|Sodium monoflurophosphate|United Kingdom marketed fluoride toothpaste
16234315|NCT01128972|Drug|Sterile water|Sterile water rinse
16234316|NCT01128959|Drug|Intravenous Carbamazepine (IV CBZ)|10 mg/mL of IV CBZ dissolved in 250 mg/mL of Captisol® (sulfobutylether-beta-cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by IV infusion every 6 hours.
16234317|NCT01128946|Drug|NaF|Fluoride toothpaste containing sodium fluoride as 1450 parts per million (ppm) F, 675 ppmF, 450 ppmF, 350ppmF.
16234318|NCT01128946|Drug|SnF|Fluoride toothpaste containing stannous fluoride (1100 ppmF)
16234319|NCT01128946|Drug|NaMFP|Fluoride toothpaste containing sodium monofluorophosphate (1000 ppmF)
16234320|NCT01128933|Procedure|Renal artery stenting|
16234321|NCT01128920|Behavioral|Skin and Needle Hygiene Intervention|Intervention incorporates psychoeducation, correction of false beliefs, counseling to counteract barriers to hygienic practices, motivational enhancement, and behavioral skills training in hygiene practices
16234322|NCT01128920|Other|No intervention - assessment-only condition|No intervention is assigned in this condition
16234323|NCT01128894|Biological|albiglutide|albiglutide weekly subcutaneous injection
16234324|NCT01128894|Drug|liraglutide|liraglutide daily subcutaneous injection, starting at 0.6mg, then up-titrating to 1.2mg then 1.8mg in accordance with prescribing information.
16234325|NCT01128881|Biological|Factor IX Concentrate (purified, virus-inactivated)|Intravenous injection/infusion; dose for prophylaxis: 20-40 IU/kg bodyweight, twice weekly (which may be adjusted to the subject´s bleeding pattern and lifestyle); dose for bleeding episodes and surgery: according to the Summary of Product Characteristics and the Product Information Leaflet of the respective country.
16234326|NCT01128868|Device|Proximal femur locking plate|Proximal femur locking plate (PF-LCP, PF-LCP Hook Plate, Periloc)
16234327|NCT01128868|Device|Intertrochanteric nail|Intertrochanteric nail (PFNA, TFN, GN)
16234328|NCT01128855|Drug|3 mg/kg GSK2402968|Weekly subcutaneous injection
16234329|NCT01128855|Drug|6 mg/kg GSK2402968|Weekly subcutaneous injection
16234330|NCT01128855|Drug|9 mg/kg GSK2402968|Weekly subcutaneous injection
16234331|NCT01128855|Drug|12 mg/kg GSK2402968|Weekly subcutaneous injection
16234332|NCT01128855|Other|Placebo|Weekly Placebo
16234333|NCT01128842|Drug|Neratinib|240 mg once daily by mouth.
16234334|NCT01128842|Drug|Capecitabine|1500 mg/m^2 twice daily by mouth.
16234335|NCT01128829|Other|Water|60 ml of water were drank 10 min before doing a OGTT
16234336|NCT01128829|Other|Sucralose|60 ml of 2 millimolar sucralose were drank 10 min before doing a OGTT
16234338|NCT01128803|Procedure|injection of the cell therapy product|Between D-15 and D-30: Cytapheresis D0: 1st injection of the cell therapy product D21: 2nd injection of the cell therapy product D42: 3rd injection of the cell therapy product and 1 injection of dendritic cells not loaded D45: cutaneous biopsies if induration > 2mm
16234339|NCT01128790|Other|Remote ischemic preconditioning|4 cycles x 5 mins upper limb blood pressure cuff inflation 20mmHg above systolic blood pressure
16234340|NCT01128790|Other|Sham Control|4 cycles x 5mins blood pressure cuff inflation to 10mmHg
16234341|NCT01128777|Behavioral|Cognitive Behavioral Group Therapy|The CBT group therapy protocol will teach adolescents coping, cognitive restructuring, and affect regulation skills to remediate skills deficits that underlie depression, anxiety, and behavior problems associated with the deployment cycle. Parents will also learn stress management and parenting skills in their own group therapy sessions that occur as the same time as the adolescent group.
16234342|NCT01128777|Behavioral|Nondirective supportive group therapy|Patient initiated discussions form the basis for the intervention for both the adolescent group and the parent group
16234343|NCT01128764|Behavioral|CBT for depression and healthy lifestyle plus exercise|CBT treatment for depressed teens will be adapted into one integrated protocol that addresses depression using CBT techniques, an exercise component, and advice regarding healthy eating.
16234344|NCT01128764|Behavioral|CBT for depression|Standard CBT treatment for depressed teens that addresses depression using CBT techniques only
16234345|NCT01128751|Procedure|Embol-X intra-aortic emboli filter|Patients in this arm receive intra-aortic filter designed to catch solid debris for neuroprotection during surgery.
16234346|NCT01128751|Procedure|DBT dynamic bubble trap|Patients in this arm receive a dynamic bubble trap to reduce gaseous micro-emboli from cardiopulmonary bypass for neuroprotection during surgery
16234347|NCT01128751|Procedure|Control group|In comparison to arm 1 and 2, patients in this arm do not receive an additional intervention during surgery
16234348|NCT01128738|Drug|GSK1358820|Onabotulinum toxin type A
16234349|NCT01128738|Drug|Placebo|Placebo
16234350|NCT01128725|Other|Alzhamyd|"The patients coming in consultation for a mnésique complaint will see each other offering the study. During a consultation, the following balance sheet will be accomplished :clinical Maintenance, collection of records and used treatments
~psycho-behaviour Valuation through Neuropsychiatric Inventory (NPI) and through Inventory Apathy
~Valuation of self-government in the activities of daily life (IADL). Further to this balance sheet, it is habitually offered on the subjects of advice (principally centered on the proposals of use of external helps for instance book memo, agenda and internal assistants medium notes-techniques and associations to keep information) and a new consultation 1 year afterwards including the same balance sheet.
~In a supplementary way in this clinical valuation, a blood sample will be accomplished at the time of inclusion and 12 months afterwards."
16234351|NCT01128712|Drug|Pregabalin|150 mg /day
16234352|NCT01128712|Drug|Pregabalin|450 mg/day
16234353|NCT01128699|Drug|Subconjunctival Avastin|Intraoperative Subconjunctival Avastin 1.25mg; single dose as an adjunct to 184 mm2 surface area Ahmed Glaucoma Valve (AGV Model FP7; New World Medical Inc., Rancho Cucamonga, California, USA)
16234354|NCT01128699|Device|Ahmed Valve implant|184 mm2 surface area Ahmed Glaucoma Valve (AGV Model FP7; New World Medical Inc., Rancho Cucamonga, California, USA)
16234355|NCT01128686|Other|No intervention|This study is retrospective chart review
16234356|NCT01128673|Device|mRI|
16234357|NCT01128647|Dietary Supplement|Fructose:glucose drink|
16234358|NCT01128647|Dietary Supplement|glucose drink|
16234359|NCT01128634|Drug|GSK573719|13 days dosing with GSK573719, once daily dosing from day 1 to 13, concurrent dosing with verapamil from day 9 to 13.
16234360|NCT01128634|Drug|GW573719/GW573719|13 days dosing with GSK573719/GW573719, once daily dosing from day 1 to 13, concurrent dosing with verapamil from day 9 to 13.
16234361|NCT01128621|Drug|GSK1292263|Tablet
16234362|NCT01128621|Drug|GSK1292263 matching placebo|Tablet
16234363|NCT01128621|Drug|Sitagliptin|Tablet
16234364|NCT01128608|Procedure|24-Hr Esohpageal pH Monitoring|There will be a 24-hr pH monitoring procedure and two 10-minute infusions each one week apart consisting of high PCO2 solution and 0.1 N HCI solution.
16234365|NCT01128608|Procedure|PCO2 Acid Perfusion and 0.1N HCI Perfusion|A small tube will be inserted through the nostril and into the esophagus. A mild CO2 solution or a mild saline solution will be administered for aprox. 10 minutes during which you will be asked questions regarding any symptoms you may experience.
16234366|NCT01128595|Drug|FF/GW642444M|
16234367|NCT01128595|Drug|GW642444M|
16234368|NCT01128595|Drug|Fluticasone Furoate|
16234369|NCT01128595|Drug|Placebo|
16234370|NCT01128582|Drug|Rozerem (ramelteon)|dosage= take 1 tablet(8 MG) 20 min. before bedtime
16234371|NCT01128582|Drug|placebo|Comparing the effect of Rozerem vs. placebo on GERD symptomatology.
16234372|NCT01128569|Drug|Fluticasone Furoate|FF
16234373|NCT01128569|Drug|FF/Vilanterol (VI; GW642444M)|FF/VI
16234374|NCT01128569|Drug|Placebo|Placebo Inhaler
16234375|NCT01128556|Drug|Bepreve|Bepreve (bepotastine besilate ophthalmic solution 1.5%) one drop in each eye twice daily
16234376|NCT01128556|Drug|Refresh Tears|Refresh Tears one drop to each eye twice daily for 7 days after the conclusion of Bepreve treatment
16234377|NCT01128543|Drug|lapatinib and Vinorelbine|Patients will receive 1250mg lapatinib once a day and vinorelbine 25mg/sqm IV Day 1and Day 8, every 3 week for 24 weeks.
16234378|NCT01128530|Drug|JNJ-32729463|250 mg tablet twice daily
16234379|NCT01128530|Drug|linezolid|600 mg tablet twice daily
16234380|NCT01128530|Drug|JNJ-32729463 placebo|1 placebo tablet twice daily
16234381|NCT01128530|Drug|linezolid placebo|1 placebo tablet, twice daily
16234400|NCT01128348|Behavioral|patient advocate|patient advocate works with patient to navigate practice and social barriers and to facilitate patient-provider communication
16234401|NCT01128335|Drug|MMF(1000mg bid) + tacrolimus + standard of care medications|MMF(1000mg bid) + tacrolimus + standard of care medications
16234402|NCT01128335|Drug|sotrastaurin (200mg bid) + tacrolimus + standard of care medications|sotrastaurin (200mg bid) + tacrolimus + standard of care medications
16234403|NCT01128335|Drug|sotrastaurin (200mg bid) + tacrolimus + standard of care medications|sotrastaurin (200mg bid) + tacrolimus + standard of care medications
16234382|NCT01128517|Behavioral|Maternal education on complementary feeding|"CF education to the mothers in intervention arm.
~Ten important key messages developed based on recommended practices (WHO/UNICEF, 2000 & 2006).
~First session --> cover the importance of breast feeding, its continuation for whole two years, hand washing, hygiene and importance of CF initiation at 6 months of age.
~Second session -->breastfeeding promotion, complementary food consistency, initial complementary food selection and age related complementary food education.
~Third session --> previous sessions recall. protein based and iron rich food encouragement.
~The control arm continue to be benefited from the lady health workers program, while breastfeeding promotion would be provided to control arm"
16234383|NCT01128517|Behavioral|Education|Maternal education on complementary food
16234384|NCT01128478|Procedure|Enteral tube feeding|Nasogastric tube feeding started within 24 h of hospital admission
16234385|NCT01128452|Drug|EVT 101|HPMC Capsule, 15 mg, once daily for 28 days
16234386|NCT01128452|Drug|Placebo|HPMC Placebo capsules, once daily for 28 days
16234387|NCT01128439|Other|No intervention|No intervention
16234388|NCT01128426|Other|No Intervention|No Intervention
16234389|NCT01128413|Device|Cheetah NICOM® PLRT|Cheetah NICOM® (non-invasive cardiac output monitoring)PLRT (passive leg raise testing) protocol: The patient while in a semi-recumbent position (legs level, torso up 45 degrees) will have 3 minutes of stroke volume and cardiac index monitoring. Following the 3 minutes, the patient will be placed in a leg raised position (torso level, legs up 45 degrees) for 3 minutes of stroke volume and cardiac index monitoring. NICOM® PLRT will be performed within 10 minutes after any fluid bolus in both arms with results blinded to the Routine Care arm. If saline locked or maintenance IV fluid rate, NICOM® PLRT will be performed every 30 minutes in both arms with results blinded to the Routine Care arm.
16234390|NCT01128413|Device|USCOM ® (Ultrasound Cardiac Output Monitor)|Patients while in the Cheetah NICOM® PLRT semi-recumbent position (legs level, torso up 45 degrees) will have simultaneous USCOM® stroke volume and cardiac index monitoring. Following the 3 minutes of Cheetah NICOM® PLRT semi-recumbent positioning, the patient will be placed in a leg raised position (torso level, legs up 45 degrees) and have simultaneous USCOM® stroke volume and cardiac index monitoring. USCOM® monitoring will be blinded to the Routine Care arm unless used as part of a provider's routine practice. USCOM® changes in SVI or CI with PLRT will be calculated after the patient leaves the ED.
16234391|NCT01128413|Device|Inferior Vena Cava (IVC) Ultrasound Collapsibility|Patients while in the Cheetah NICOM® PLRT semi-recumbent position (legs level, torso up 45 degrees) will have a simultaneous 6-12 second ultrasound recording of their IVC. These recordings will be reviewed later by an ultrasonographer and graded for volume responsiveness. The reviewing ultrasonographer will be blinded to the Cheetah NICOM® PLRT results.
16234392|NCT01128413|Behavioral|CURVES Questionnaire|The CURVES (CardiovascUlar Response & Volume Estimation in Shock) Questionnaire consists of multiple provider questions aimed at defining the presumed shock etiology and anticipated responses to interventions. This will be administered to both arms.
16234393|NCT01128413|Biological|Lactate Clearance|Lactate samples will be drawn at time 0, 1, 3, & 6 hours (or at ED departure if before 6 hours). Time 0 lactate will be revealed to the Routine Care arm and subsequent lactates revealed to the Routine Care arm only if serial lactates are part of the provider's routine practice.
16234394|NCT01128413|Biological|500ml Normal Saline Bolus|Patients randomized to the experimental arm and having a >/= 15% change in stroke volume index (SVI) or cardiac index (CI) via Cheetah NICOM®PLRT will be given a 500ml normal saline fluid bolus.
16234395|NCT01128413|Biological|Clinician Discretion Intravenous Fluid Management|Clinicians caring for patients randomized to the Routine Care arm will within 10 minutes after any fluid bolus be asked to decide via their clinical discretion if they want to re-bolus, saline lock, or place the patient on a maintenance IV fluid rate. If the patient is on a saline lock or maintenance fluid rate, clinicians will be asked every 30 minutes to decide via their clinical discretion to re-bolus, saline lock, or place the patient on a maintenance IV fluid rate.
16234396|NCT01128387|Drug|Panitumumab|dose escalating 1.5mg/kg or 2.5mg/kg weekly during radiation. Cisplatin on Days 1 and 29, Fluorouracil on Days1-4 and Days 29-32.
16234397|NCT01128374|Procedure|Periodontal Scaling and root planing|Participants will be instructed to brush their teeth using the modified Bass toothbrushing technique; the use of interproximal hygiene aids such as proximal brush or dental floss will be included. A full mouth scaling and root planning will be performed in 2 appointments (2 hours each) with the use of local anesthesia (typically 2% lidocaine with 1:100,000 epinephrine). In the control group, this treatment will be performed after all the data and samples have been collected and will encompass the last 2visits. Periodontal scaling and root planning treatment has been defined by The American Academy of Periodontology (AAP) as the standard of care for patients with periodontal disease. An ultrasonic instrument, scalers and curettes will be utilized to remove calculus and obtain a smooth root surface. The experimental subjects will be appointed 1 week later to complete the scaling and root planning procedure
16234398|NCT01128361|Behavioral|Aerobic Exercise|Participants randomized to this group will perform 150 minutes a week of aerobic exercise over 3-5days. Participants will begin exercising 3 times the first week for 20 minutes, increasing to three bouts of 25 minutes the second week. Thereafter, weekly exercise duration will be increased until their target duration of 150 minutes is achieved in week 6. Exercise trainers will assist participants in adjusting exercise routines to achieve their weekly exercise duration goals. Use of equipment, achievement of target HR and safety will be closely monitored by the trainer through the course of the study. Each subject will wear a Polar F4 heart monitor (Polar USA) for recording heart rate during each exercise session. Subjects unable to exercise continuously on the treadmill will perform intermittent training until the target duration is reached. The majority of the exercise sessions will involve walking on a treadmill.
16234399|NCT01128361|Behavioral|Stretching|This groups intervention is designed to match the aerobic exercise intervention with respect to participation and socialization. Stretching and toning has been repeatedly used as control intervention for exercise studies.The schedule and format will be identical to the aerobic conditioning group to best balance confounding variables such as attention, social interactions, and other unknown variables that might influence the results. An experienced and trained exercise instructor will run the stretching sessions three days a week at the local YMCA. We will monitor changes in heart rate with Polar F4 heart monitors (Polar USA) during the sessions to assess, and minimize, potential aerobic benefits from the intervention.
16234405|NCT01128322|Drug|S-Amlodipine, Telmisartan|
16234406|NCT01128322|Drug|S-Amlodipine|
16234409|NCT01128309|Behavioral|Stress Reduction Intervention|eight week group program, plus daily homework practice
16234410|NCT01128309|Behavioral|Active Control intervention|weekly group meetings for eight weeks, plus daily homework practice
16234411|NCT01128296|Drug|Hydroxychloroquine|Oral dosing daily starting at 48 hours before first dose of gemcitabine (starting on Day -2) and for a total of 31 days (ending on Day 29), prior to surgical resection. Capsules are available in 200 mg strengths. Daily doses are 200, 400, 600, 800, 1000, or 1200 mg, and will be administered BID for doses above 200 mg.
16234412|NCT01128296|Drug|Gemcitabine|Intravenous administration on Days 1 and 15, with the infusion given at the fixed dose rate of 10mg/m2/min (e.g. 150 min for a 1500 mg/m2 dose).
16234413|NCT01128270|Drug|Dichloroacetate environmental dose|On day 6 they receive Dichloroacetate 2.5 ug/kg orally times 1 and have pharmacokinetics.
16234414|NCT01128270|Drug|Chloral Hydrate environmental dose|Study subjects are given 1.5 ug/kg of Chloral Hydrate for 5 nights and pharmacokinetics are done on night 1 and 5.
16234415|NCT01128270|Drug|Dichloroacetate therapeutic dose|Subjects receive 25 mg/kg DCA on Day 6. Pharmacokinetics are done on nights 1 and nights 5.
16234416|NCT01128270|Drug|Chloral Hydrate therapeutic dose|Subject is given 25 mg/kg of Chloral Hydrate for five nights.
16234417|NCT01128257|Drug|alendronate|As prescribed by physician
16234418|NCT01128257|Drug|ibandronate [Bonviva/Boniva]|As prescribed by physician
16234419|NCT01128244|Dietary Supplement|Vitamin B6|Subjects will receive vitamin B6 supplementation.
16234420|NCT01128244|Procedure|Infusion of labeled serine, methionine and leucine|Subjects will be given an infusion of the stable isotope labeled amino acids, serine, methionine and leucine prior to vitamin B6 supplementation and after 28 days of B6 treatment. In addition, they will receive a special diet 2 days prior to the infusion and will have weekly weight, blood, and visits to the clinic.
16234421|NCT01128218|Drug|Tumor fluorescence|oral doses in phase 1 study of 10mg/kg, 20 mg/kg, 30 mg/kg, 40 mg/kg and 50 mg/kg
16234422|NCT01128192|Drug|pasireotide|Pasireotide 600 μg (batch number Y050DE) or 900 μg bid (batch number Y1270908) for subcutaneous injection. Placebo (batch number Y069HC) for subcutaneous injection.
16234423|NCT01128179|Drug|Lanthanum carbonate|1000 mg in chewable tablets administered three times a day (for a total of 3000 mg/day) for 12 weeks
16234424|NCT01128179|Drug|Placebo|Matching placebo chewable tablets administered 3 times a day for 12 weeks
16234425|NCT01128166|Device|COGNIS CRT-D|"Patients with existing or newly implanted COGNIS® CRT-D pulse generators (PG)are enrolled in the study. PG is modified by the download of investigational software called Sensor Research Device-1™ (SRD-1). The goal of the SRD-1 system is to collect sensor data without affecting the delivered CRT-D therapy. This is accomplished through the conversion of an implanted COGNIS PG into a SRD-1 PG by downloading investigational software. Only a market approved COGNIS model N119/N120/P107/P108 device may be converted to a SRD-1 investigational device. There will be no PG hardware changes resulting from the conversion."
16234426|NCT01128153|Drug|Saxagliptin|5 mg tablet once daily for 24 weeks to be taken orally
16234427|NCT01128153|Drug|Placebo|tablet once daily for 24 weeks to be taken orally
16234428|NCT01128140|Behavioral|Motivational Enhancement Therapy|MET, a 30-60 minute telephone session, seeks to increase motivation for change by highlighting inconsistencies between substance use behaviors and beliefs and negative consequences experienced as a result of the behaviors. The counselor will guide the participant in reviewing the Personal Feedback Report (PFR), using MI strategies to elicit the participant's reactions and foster motivation for change. The PFR will show the participant's self-reported alcohol and drug use behavior, consequences of SA, and the participant's perceived and actual descriptive norms for SA behavior. The second phase will target strengthening commitment to change. Counselors will explore with participants the pros and cons of seeking treatment. As the participant verbalizes potential benefits of learning more about treatment, the counselor will use MI skills to encourage elaboration of his/her thinking with the goal of tipping the scale toward a decision to consider taking steps toward treatment.
16234429|NCT01128140|Behavioral|Education|Participants will receive educational information on the health, psychological, social, and legal consequences of substance abuse. Included in the session will be: legal and behavioral definitions of SA, the social and legal consequences of SA, impact of SA on military duty, a review of the policies on substance use in the military, and treatment resources. The session will be conducted via the telephone and will last from 30-60 minutes. Counselors will present information in a didactic manner and will avoid the use of Motivational Interviewing skills (reflective listening, developing discrepancy, reinforcing participant statements regarding change).
16234430|NCT01128127|Behavioral|Group education, audit-feedback and computer support|"Psycho-educational group workshop: two theory-practice sessions on both evidence-based guidelines on PPI-NSAID prescription and communication and negotiation skills to deal with patients. All participants will fill out an initial questionnaire concerning prescribing patterns and barriers to appropriate prescription. All attendees will be given a reminder printed material designed to give the necessary information in a brief fashion and for maximal visual impact.
~Audit-Feedback: participants will receive, monthly and by e-mail, an individualized report with data of their own appropriate/inappropriate PPI prescriptions and avoidable costs.
~CCDSS: interactive computer program designed to assist physicians with decision making when prescribing PPI associated to NSAID. It consists in pop-up alert screens that aim to influence prescription choice according to each patient characteristics and evidence-based clinical guidelines."
16234431|NCT01128127|Behavioral|Audit-feedback and computer support|"Audit-Feedback: participants will receive, monthly and by e-mail, an individualized report with data of their own appropriate/inappropriate PPI prescriptions and avoidable costs
~CCDSS: interactive computer program designed to assist physicians with decision making when prescribing PPI associated to NSAID. It consists in pop-up alert screens that aim to influence prescription choice according to each patient characteristics and evidence-based clinical guidelines."
16234432|NCT01128127|Behavioral|Control|"Usual intervention includes:
~Compulsory attendance both to courses (10-12 hours) and to short sessions (around 30 min.) on the rational use of drugs held in groups and during working hours. Each primary care physician attends to 1-2 courses and 3-4 short sessions per year.
~Every three months, physicians receive a feedback paper with information on his/her own prescribing overall costs comparing to his/her primary care center average cost.
~Distribution of a printed booklet of recommendations, delivered personally or through mass mailings, on the prescribing of PPI-NSAID."
16234625|NCT01126450|Other|polymerase chain reaction|Correlative studies
16234433|NCT01128114|Drug|Quetiapine fumarate (Seroquel XR)|Extended Release(XR) 50 mg, 200 mg, 300 mg and/or 400 mg tablet, oral, once daily in the evening, from assignment to the end of the study.
16234434|NCT01128101|Drug|Spironolactone|The group who receive spironolactone, the dose employed will be 25 mg each other day and titrated to 25 mg daily according to potassium.
16234435|NCT01128075|Device|RebiSmart™|Electronic self-injection device (RebiSmart™) to inject Rebif®
16234436|NCT01128075|Device|RebiSmart™|Electronic self-injection device (RebiSmart™) to inject Rebif®
16234437|NCT01128049|Behavioral|Subjective Questionnaire|The team will use a one page questionnaire to obtain subjective input before the first set of measurements and after instilling the Saline drop.
16234438|NCT01128049|Procedure|Measurement with wavefront sensor (right eye, then left eye)|The wavefront instrument measures the eye's ability to create a sharp image by briefly shining a laser light from the wavefront sensor into the eye and measuring the light that bounces back through the cornea. For these measurements, subjects will sit on a chair and be instructed to place their chin in a chin rest and lean their forehead against a forehead rest. The subject will be instructed to hold his/her head steady, look in a certain direction, blink or not blink. We will obtain the measurements over a short period of up to approximately 45 seconds. We will start recording data asking the subject to either blink naturally or to hold his/her eye open for a few (up to 10) seconds, and repeat the blink and hold sequence usually for up to four times.
16234439|NCT01128049|Drug|Instill Saline Drop|One drop will be instilled in both eyes and patient will wait 5 minutes prior to repeating the questionnaire and wavefront sensor. A single drop is approximately 30 µL and will be placed into the inferior cul-de-sac while the patient looks up.
16234440|NCT01128023|Other|Myocardial perfusion imaging using Rb-82 PET or Tc-99m or Tl SPECT|Patients will undergo a clinically indicated PET Rb-82 myocardial perfusion scan for diagnosis or risk stratification of CAD. This cohort will be matched to the SPECT perfusion database.
16234441|NCT01127984|Drug|tissucol|dosage: 2 or 5 ml Frequency: 1 application Duration: 5 minutes
16234442|NCT01127984|Procedure|drainage system|application of vacuum drainage system
16234443|NCT01127958|Device|PCI with a drug-eluting balloon|PCI with a drug-eluting balloon for in-stent restenosis
16234444|NCT01127958|Device|PCI with a drug-eluting stent|PCI with a drug-eluting stent for in-stent restenosis
16234445|NCT01127945|Drug|statin|"adding atorvastatin 80mg, po on day (1 to 3) acute heart failure therapy
~acute heart failure therapy"
16234446|NCT01127932|Behavioral|Psychoeducation for substance abuse|This active control provides detailed information about substance use, suicide risk, and depression to those enrolled.
16234447|NCT01127932|Behavioral|CBT for suicide in Substance abuse|The therapeutic intervention group is designed to provide beneficial coping strategies that are helpful in dealing with both substance use and suicidal thoughts.
16234448|NCT01127919|Behavioral|Aerobic Exercise Training|40 minutes, 3 times a week for 35 weeks.
16234449|NCT01127919|Other|Cognitive Component|Provide general information about health and fitness
16234450|NCT01127906|Drug|PF-04531083 100mg|Oral PF-04531083 100mg suspension single dose
16234451|NCT01127906|Drug|PF-04531083 2000mg|Oral PF-04531083 2000mg suspension single dose
16234452|NCT01127906|Drug|Placebo suspension|Oral Placebo suspension (matched to PF-04531083 suspension)
16234453|NCT01127906|Drug|Placebo tablet|Oral Placebo tablet (matched to Oxycodone)
16234454|NCT01127906|Drug|Oxycodone 20mg|Oral Oxycodone 20mg (Oxycontin) controlled release formulation
16234455|NCT01127893|Biological|Tanezumab|Tanezumab 10 mg administered by subcutaneous injection every 8 weeks for up to 7 injections
16234456|NCT01127893|Biological|Tanezumab|Tanezumab 5 mg administered by subcutaneous injection every 8 weeks for up to 7 injections
16234457|NCT01127893|Biological|Tanezumab|Tanezumab 2.5 mg administered by subcutaneous injection every 8 weeks for up to 7 injections
16234458|NCT01127880|Drug|Ancef or Clindamycin|1 gm of Ancef or 300 mg Clindamycin for those who are penicillin allergic
16234459|NCT01127880|Drug|Placebo|.9% Normal Saline as a placebo
16234460|NCT01127867|Dietary Supplement|dietary intervention|dietary intervention
16234461|NCT01127841|Drug|Rituximab and Bendamustine|Rituximab: 375 mg/m2/day, day 1 of each cycle, iv. Bendamustine: 90 mg/m2/day, days1 and 2 fo each cycle, iv.
16234462|NCT01127828|Other|Arla Yoghurt with no probiotic|two servings of 200 ml of investigational products per day
16234463|NCT01127828|Other|Probiotic yoghurt (Cultura)|200 ml per day
16234464|NCT01127789|Device|Transcranial Direct Current Stimulation|Transcranial Direct Current Stimulation
16234465|NCT01127776|Device|APOS SYSTEM|The trial group will receive APOS walking system The control group will receive the same walking protocol as the trial group without biomechanics units
16234466|NCT01127776|Other|APOS SYSTEM without biomechanics units.|The control group will receive the same walking protocol as the trial group without biomechanics units
16234467|NCT01127763|Drug|RAD001|
16234468|NCT01127763|Drug|Carboplatin|
16234469|NCT01127750|Drug|FTY720|
16234470|NCT01127737|Behavioral|Educational Intervention|Mnemonic and a workbook used by kidney transplant recipients to assist with early early detection of SCCs.
16234471|NCT01127737|Behavioral|Placebo|Completed surveys
16234472|NCT01127724|Drug|vitamin B12 treatment|Group I- will receive sublingual vitamin B12 treatment, 1000 mcg per day for 6 months Group II- will receive sublingual vitamin B12 treatment, 100 mcg per day for 6 months Group III- will receive sublingual vitamin B12 treatment, 2000 mcg per day for 6 months
16234473|NCT01127685|Device|Smart_Step weight bearing insole|The use of a weight-bearing measuring device in determining weight-bearing deficits following Anterior Cruciate Ligament Reconstruction
16234474|NCT01127672|Biological|platelet rich plasma|"30 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP).
~Under sterile conditions, patients will receive a 3 cc PRP injection (consisting of their own PRP) with 1 cc of 2% lidocaine into the origin of the plantar fascia, administered by an orthopedic surgeon.
~This will be done using a plantar approach. A peppering technique spreading in clockwise manner will be used to achieve a more expansive zone of delivery, with a maximum of 10 passes through the fascia itself.
~The patient will be monitored for 10 minutes in clinic for adverse reactions."
16234475|NCT01127672|Drug|corticosteroid injection|"Under sterile conditions, patients will receive a 4 cc injection consisting of 2 cc Celestone Soluspan (6mg/ml) and 2 cc of 1% lidocaine into the origin of the plantar fascia, administered by an orthopedic surgeon.
~This will be done using a plantar approach. A peppering technique spreading in clockwise manner will be used to achieve a more expansive zone of delivery, with a maximum of 10 passes through the fascia itself.
~The patient will be monitored for 10 minutes in clinic for adverse reactions."
16234476|NCT01127659|Drug|testosterone|intramuscular every 2 weeks
16234477|NCT01127659|Drug|placebo|saline intramuscular every 2 weeks
16234478|NCT01127646|Drug|Atomoxetine|25-80 milligrams (mg) administered orally, once daily.
16234479|NCT01127646|Drug|Osmotic-release oral system methylphenidate|18-54 mg administered orally, once daily.
16234480|NCT01127646|Drug|Placebo|Administered orally, once daily for random nonconsecutive 6 days during 4-week treatment period.
16234481|NCT01127633|Drug|Solanezumab|400 mg of solanezumab administered once every 4 weeks by intravenous infusion (IV) for up to 8 years.
16234482|NCT01127633|Drug|Placebo|Participants were from feeder studies (LZAM or LZAN). Placebo administered intravenously every 4 weeks through Week 80.
16234483|NCT01127620|Drug|Bilastine|20 mg encapsulated tablets
16234484|NCT01127620|Drug|Cetirizine|10 mg encapsulated tablets
16234485|NCT01127620|Drug|Placebo|encapsulated tablets
16234486|NCT01127607|Drug|lisdexamfetamine|3 week with-in subject lead in phase to find optimal dose ranging from 30 mg to 70mg
16234487|NCT01127594|Drug|Temozolomide|Dose level selection will proceed according to the modified Accelerated Titration Design. The starting dose will be TMZ 200mg/m2 x 0.09 BSA for the upper extremity and 200mg/m2 x 0.18 BSA for the lower extremity. We will enroll one-patient cohorts with dose doubling between cohorts until 1st occurrence of a ≥ CTC (Common Terminology Criteria) grade 2 adverse event. At that time, the present cohort and all future cohorts will be extended to enroll 3 to 6 patients.
16234488|NCT01127581|Drug|MVI 200|Dose reservoir of 200 mcg of misoprostol in a hydrogel polymer vaginal insert within a retrieval system. The MVI 200 will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
16234489|NCT01127581|Drug|Dinoprostone Vaginal Insert (DVI)|Dose reservoir of 10 mg of dinoprostone in a hydrogel polymer vaginal insert within a retrieval system. The DVI will be kept in place for up to 24 hours or will be removed earlier if one of the following occur: onset of active labor, intrapartum adverse event necessitating discontinuation of the study drug, other reasons including maternal request.
16234490|NCT01127568|Drug|Propranolol is available in generic form as the Wyeth product under the trade name Inderal.|The study medication will consist of a dose of 2/3 mg/Kg of short-acting propranolol or placebo, followed 2 hours later by a dose of 1 mg/Kg of long-acting or placebo. The medication will be prescribed by the clinic's physician after medical check-up. A nurse will monitor blood pressure. According to, 40 mg of short-acting propranolol dose should produce a peak blood level of approximately 25 ng/ml at 2 hours, which the additional 60 mg long-acting propranolol should further increase by no more than 5ng. The decay of the blood level induced by the 40 mg short-acting dose after its 2-hour peak will outstrip the further rise induced by the 60 mg long-acting proposal dose, so that blood levels will not rise above this peak 30 ng/ml, which is within the therapeutic clinical range. If the participant tolerates the combination dose without any difficulty, during subsequent sessions, both the short- and long-acting doses will be given together immediately after memory reactivation.
16234491|NCT01127555|Drug|5-fluorouracil, leucovorin, oxaliplatin|D1 Oxaliplatin 85mg/m2 D1, 2 LV 30mg/m2 IV push D1, 2 5-FU 1500mg/m2 CIV over 24hrs Every 2 weeks
16234492|NCT01127542|Drug|Lenalidomide|Daily oral lenalidomide. Starting dose of 2.5mg daily, escalating to target dose of 10mg daily.
16234493|NCT01127529|Biological|Protein C Concentrate (Human)|Commercially available Ceprotin will be prescribed, obtained and administered by the investigator according to local standard of care.
16234494|NCT01127503|Drug|Metyrosine|Metyrosine (250 mg capsules) were to be used at all dose levels (administered as multiples of that dosing unit). The starting dose was 250 mg/day of metyrosine. Dose escalation was to be carried out weekly for 8 weeks (up to a maximum of 8 capsules/day [2000 mg/day if metyrosine]) with dosage increments of 1 capsule/day per week. Weekly dose escalation was to stop based upon the investigator's assessment of safety, but not efficacy (i.e., dose escalation was to be forced to the maximum of 8 capsules/day assuming acceptable safety and tolerability).
16234495|NCT01127503|Drug|Placebo|Placebo capsules were identically matched to Metyrosine.
16234496|NCT01127490|Drug|Duloxetine|Subjects will be titrated onto Duloxetine over one week by taking 30 mg every day for seven days. Week 2 the subject will begin to take 60 mg per day until the end of the study. If the subject wishes to stop taking Duloxetine, she will be given 30 mg per day for one week for down titration.
16234497|NCT01127490|Procedure|Skin biopsy|3 mm skin biopsies will be obtained from the dominant trapezius and the glabrous hypothenar area of the hand
16234498|NCT01127477|Drug|1: Hydroxyethyl starch 130/0.4, 6 %|1: Up to 50 ml 6 % hydroxyethyl starch 130/0.4/kg body weight administered intravenously from start of surgery (skin incision) until two hours after end of surgery.
16234499|NCT01127464|Drug|DCVax-001|Comparison of 3 different doses of DCVax-001 administered with poly-ICLC, the administration of poly-ICLC alone, or a placebo control
16234500|NCT01127464|Drug|Poly-ICLC|Comparison of 3 different doses of DCVax-001 administered with poly-ICLC, the administration of poly-ICLC alone, or a placebo control
16234501|NCT01127464|Drug|Placebo|Comparison of 3 different doses of DCVax-001 administered with poly-ICLC, the administration of poly-ICLC alone, or a placebo control
16234502|NCT01127451|Drug|Denileukin diftitox|"Test product: dose and mode of administration:
~denileukin diftitox was originally administered by intravenous infusion over 30-60 minutes according to 1 of 2 treatment arms:
~12 mcg/kg/day on Days 1 through 4 of each 21-day treatment cycle, for a total of 4 cycles (12 weeks);
~12 mcg/kg/day on Days 1, 8, and 15 of each 21-day treatment cycle, for a total of 4 cycles (12 weeks)
~ARM 2 is now closed. Patients experiencing clinical benefit (irSD, irPR, or irCR per irRC) after 4 cycles of treatment, may continue their denileukin diftitox treatment for up to 8 cycles."
16234503|NCT01127438|Drug|fospropofol disodium Subgroup 1 Lower Dose|Dose of Initial IV (Titration) Bolus 6.5mg/kg) (administered to Subgroup 1, Weight < 60 kg and Age < 65 years and ASAI and II)
16234504|NCT01127438|Drug|fospropofol disodium Subgroup 1 Approved Dose|(Dose of Initial IV (Titration) Bolus 385mg) (Administered to Subgroup 1, Weight <60 kg and Age <65 years and ASAI and II)
16234505|NCT01127438|Drug|fospropofol disodium Subgroup 2 Lower Dose|Dose of Initial IV (Titration) Bolus 4.875 mg/kg) (administered to Subgroup 2, Weight < 60 kg and Age >/=65 years and ASA 3 or 4
16234506|NCT01127438|Drug|fospropofol disodium Subgroup 2 Approved Dose|(Dose of Initial IV (Titration) Bolus 297.5mg) (Administered to Subgroup 2, Weight <60 kg and Age >/=65 years and ASA 3 or 4
16234507|NCT01127438|Drug|fospropofol disodium Subgroup 3 Lower Dose|(Dose of Initial IV (Titration) Bolus 3.9mg/kg) (Administered to Subgroup 3, Weight >/= 60 kg and Age >/= 65 years and ASA 3 or 4
16234508|NCT01127438|Drug|fospropofol disodium Subgroup 3 Approved Dose|Dose of Initial IV (Titration) Bolus 4.875 mg/kg) (Administered to Subgroup 3, Weight >/= 60 kg and Age >/= 65 years and ASA 3 or 4
16234509|NCT01127425|Procedure|laparoscopic colonic resection|Conventional surgery compared to laparoscopic sigmoid resection
16234510|NCT01127425|Procedure|laparoscopic sigmoid resection|sigmoid resection by laparoscopic surgery
16234511|NCT01127412|Behavioral|Physical activity stimulating program|
16234512|NCT01127386|Drug|Lenalidomide|25mg od, dose reduction according to toxicity
16234513|NCT01127386|Drug|Lenalidomide|start with 5mg od and increase of dosage to 10mg, 15mg or 25mg until CRP response (50% decrease)
16234514|NCT01127386|Other|basic cachexia management (prokinetics, physical activity counselling, nutritional counselling)|twice during study
16234515|NCT01127373|Radiation|Multi-Beam Intensity-Modulated Radiation Therapy|IMRT with multiple beams will be utilized to treat the breast or chest wall and axillary, supraclavicular and internal mammary lymph nodes. Treatment will be delivered once a day, 5 days a week for approximately 5 weeks. All missed radiation treatment visits will be made up. Daily set-up error will be checked prior to the delivery of every treatment.
16234516|NCT01127373|Behavioral|BreastQ questionnaire-|MSKCC Department of Surgery. For patients who received a mastectomy with or without reconstruction, the questionnaire will be administered at baseline and 5-7 months after treatment.
16234517|NCT01127360|Drug|Bevacizumab|Intravitreal injections
16234518|NCT01127360|Drug|Ranibizumab|Intravitreal injections
16234519|NCT01127321|Other|Placebo|A single double-blind dose of placebo matched to MEDI-570 subcutaneous injection on Day 1.
16234520|NCT01127321|Biological|MEDI-570 0.03 MG|A single open-label dose of MEDI-570, 0.03 milligram (mg) subcutaneous injection on Day 1.
16234521|NCT01127321|Biological|MEDI-570 0.1 MG|A single open-label dose of MEDI-570, 0.1 mg subcutaneous injection on Day 1.
16234522|NCT01127321|Biological|MEDI-570 0.3 MG|A single double-blind dose of MEDI-570, 0.3 mg subcutaneous injection on Day 1.
16234523|NCT01127321|Biological|MEDI-570 1 MG|A single double-blind dose of MEDI-570, 1 mg subcutaneous injection on Day 1.
16234524|NCT01127308|Drug|Ertugliflozin|Ertugliflozin 25 mg will be administered as a single oral suspension containing approximately 100 uCi of [14C]ertugliflozin
16234525|NCT01127295|Drug|Tamoxifen, Letrozole, Anastrozole or Exemestane|Tamoxifen 20 mg/day during 5 years Létrozole 2.5 mg/day during 5 years Anastrozole 1 mg/day during 5 years Exémestane 25 mg/day during 5 years
16234526|NCT01127282|Drug|Vitamin (vitamin A 15 mg,C 500 mg, E 400IU)|Vitamin (vitamin A 15 mg,C 500 mg, E 400IU) 1T po for 5 days in addition to anti-viral agent and antipyretics
16234527|NCT01127282|Drug|Placebo (digestive tablet)|Placebo (digestive tablet) 1T po for 5 days in addition to anti-viral agent and antipyretics
16234528|NCT01127269|Drug|INSULIN GLARGINE|Pharmaceutical form: solution for injection Route of administration: sub-cutaneous injection Dose regimen: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 ml)
16234529|NCT01127256|Drug|zonisamide|Initial dose was 100mg/day, increased by 100mg. The maximum dose was 600mg/day.
16234530|NCT01127256|Drug|carbamazepine|Initial dose was 100mg/day, increased by 200mg every 1 week to 600mg/day. The maximum dose was 1200mg/day.
16234531|NCT01127243|Procedure|day-case laparoscopic supracervical hysterectomy|patients discharged home the same day of the operation
16234532|NCT01127243|Procedure|inpatient LSH|patients discharged home the day after the operation
16234533|NCT01127217|Drug|amlodipine/losartan|amlodipine 5mg/losartan 50mg, amlodipine 10mg/losartan 50mg (+HCTZ 12.5mg)
16234534|NCT01127217|Drug|amlodipine|amlodipine 5mg, amlodipine 10mg (+ HCTZ 12.5mg)
16234535|NCT01127204|Drug|AZT-3TC-LPV/r twice a day|AZT sirup (10mg/ml): 4 mg/kg or 180 mg/m2 twice daily 3TC sirup (10mg/ml): 4 mg/kg twice daily LPV/r sirup (80/20 mg/ml): 12 mg/kg twice daily
16234536|NCT01127204|Drug|ABC-3TC-EFV once a day|ABC sirup (20mg/ml): 16 mg/kg once daily in the morning 3TC sirup (10mg/ml): 8 mg/kg once daily in the morning EFV sirup (30mg/ml): 25 mg/kg once daily in the morning before food intake
16234537|NCT01127191|Other|military equipment|Military exercise of 24 hours
16234538|NCT01127178|Drug|E7016 + TMZ|Single-Dose PK Period (single oral dose of E7016 on Day -7) in the Dose-Escalation Component; Multiple-Dose Treatment Cycles (7 days of oral E7016 + 5 days of oral TMZ) added in Cycle 1 of the Dose-Escalation Component and in Cycles 1 through 6 of the Expansion Component.
16234539|NCT01127165|Drug|zonisamide low dose group|Initial dose was 2mg/kg/day, increased after 1~2 weeks to 3~4mg/kg/day.
16234540|NCT01127165|Drug|zonisamide high dose group|Initial dose was 2mg/kg/day, increased after 2~4 weeks to 6~8mg/kg/day.
16234541|NCT01127152|Procedure|Measure of arterial pressure|Measure of arterial pressure will occur every five minutes during the thirty minutes before the relay and during the fifteen minutes after the relay.
16234542|NCT01127126|Drug|Bryophyllum pinnatum, Placebo in form of Lactose|"Comparison Bryophyllum (2100mg/d) against Placebo (2100mg/d) regarding effectivity and safety.
~Bryophyllum and Placebo are both administered for 8 weeks. Bryophyllum and Placebo are both given in form of capsules, 350mg per capsule, 2-2-2/d."
16234543|NCT01127113|Other|Infusion of investigational product|The investigational product will be delivered via intravenous infusion
16234544|NCT01127113|Other|Cardiac magnetic resonance imaging|Cardiac MRI will be performed prior to infusion of investigational product and 1, 2, 7 and 30 days after.
16234626|NCT01126450|Genetic|polymorphism analysis|Correlative studies
16234627|NCT01126437|Drug|tiotropium 18 mcg|HandiHaler
16234628|NCT01126437|Drug|tiotropium 1.25 mcg (2 actuations/day)|soft mist inhaler 2 actuations=2 puffs/day
16234545|NCT01127100|Drug|transdermal fentanyl matrix, gabapentin|"transdermal fentanyl matrix: during 1st to 6th days, 12ug/h of fentanyl matrix will be applied. During 7th to 28th days, the dosage of fentanyl matrix will be increased until the pain score decrease not more than 2 every 6 days. The maximal dosage is 100ug/h. During 29th to 56th days, the dosage will be maintained.
~Gabapentin: the 1st day, 300mg hs, the 2nd day, 300mg bid, the 3th to 4th days, 300mg tid, the 5th to 6th days, 300mg-300mg-600mg the 7th to 28 days, the dosage will be increased until the pain score decreased not more than 2 and the maximal dose is 2400mg per day. During 29th to 56th days, the dosage will be maintained."
16234546|NCT01127087|Drug|Oxazyme|"Oxazyme (registered trademark) is a non-systemic orally delivered drug composed of recombinant oxalate decarboxylase (OxDC). It is formulated to enzymatically degrade available dietary oxalate prior to its absorption.
~Dosing: 1gm Oxazyme containing approximately 1600 Units OxDC in a sachet administered BID together with lunch and dinner. Subjects were instructed to open the oxazyme sachets and either sprinkle on food or add to a glass of water or fruit juice and consume the contents with a meal twice daily."
16234547|NCT01127074|Biological|KS24.22 cells|"The first four vaccinations, which were given every two weeks, were followed by four monthly vaccinations. Additional vaccinations were permitted on request for patients who exhibited stable disease (SD).
~Immediately before administration, KS24.22 cells were thawed and lethally irradiated (200 gray). KS24.22 cells were adjusted to 107/ml in Ringer-Lactate-solution, transferred to 1 ml syringes and stored on ice until injected within a time frame of 2h. Vaccinations were given i.d. in the thigh with a total volume of 1 ml divided between two injection sites."
16234548|NCT01127061|Behavioral|Exercise training|4 months of exercise training that is custom-designed based on individual cardiopulmonary stress test data. Regimen starts at low intensity (60% of heart rate reserve) and frequency (20 minutes, 3 days per week) and increases with a goal of 70% of heart rate reserve and exercising 60 minutes 4-7 days per week.
16234549|NCT01127048|Drug|Suppositories containing Ivy leaves dry extract|Suppositories containing Ivy leaves dry extract
16234550|NCT01127048|Drug|Placebo|Suppositories containing no Ivy leaves dry extract
16234551|NCT01127035|Biological|sublingual immunotherapy|
16234552|NCT01127035|Biological|placebo|
16234553|NCT01127022|Dietary Supplement|choline chloride|Women will consume a diet providing 380 mg/d total choline plus 100 mg/d supplemental choline [from choline chloride] for a total choline intake of 480 mg/d. The choline chloride will be administered in cran-grape juice.
16234554|NCT01127022|Dietary Supplement|Choline Chloride|Women will consume a diet providing 380 mg/d total choline plus 550 mg/d supplemental choline [from choline chloride] for a total choline intake of 930 mg/d. The choline chloride will be administered in cran-grape juice.
16234555|NCT01127009|Drug|bortezomib|Given IV
16234556|NCT01127009|Drug|mitoxantrone hydrochloride|Given IV
16234557|NCT01127009|Drug|etoposide|Given IV
16234558|NCT01127009|Drug|cytarabine|Given IV
16234559|NCT01127009|Other|flow cytometry|Correlative studies
16234560|NCT01126996|Procedure|Venepuncture|"Venepuncture and blood sample collection in 2010 in a sample of children who received a single dose of a MenC conjugate vaccine at age 1-3 years 10 years earlier.
~A booster dose of a MenC conjugate vaccine (optional)."
16234561|NCT01126983|Device|Suture|Suture (2.0 Mono-filament nylon suture) will be used to secure the leads to the skin. Benzoin and Steri-strips will also be used.
16234562|NCT01126983|Device|Lead Anchor|Suture (2.0 Mono-filament Nylon suture) will be applied over the lead anchor(Lead Anchor St.Jude Medical Co, model-long, No# 1106) to the skin. Benzion and Steri-strips will also be used.
16234563|NCT01126970|Drug|Velneperit 400 mg|Velneperit 400 mg q.d.
16234564|NCT01126970|Drug|Orlistat 120 mg|Orlistat 120 mg t.i.d
16234565|NCT01126970|Drug|Orlistat Placebo|Orlistat Placebo t.i.d.
16234566|NCT01126970|Drug|Velneperit Placebo|Velneperit Placebo q.d
16234567|NCT01126970|Other|Reduced Calorie Diet|Reduced calorie diet
16234568|NCT01126957|Drug|Ketamine|Ketamine was given as a 0.5mg / Kg bolus.
16234569|NCT01126957|Drug|Placebo|Placebo given as an bolus to control group.
16234570|NCT01126957|Drug|Fentanyl|Fentanyl 0.5 - 1.5 micrograms given to both arms prior to Ketamine or placebo
16234571|NCT01126957|Drug|Propofol|Propofol given to both arms to maintain sedation throughout procedure.
16234572|NCT01126944|Device|heart mate II|left ventricular assist device
16234573|NCT01126918|Behavioral|Body Project|Participants in this intervention attend four 1-hour group meetings (one per week for four consecutive weeks) in which they complete a series of written and verbal exercises intended to increase body satisfaction.
16234574|NCT01126892|Drug|Nilotinib|
16234575|NCT01126879|Dietary Supplement|genistein|Given orally
16234576|NCT01126879|Other|placebo|Given orally
16234577|NCT01126879|Procedure|therapeutic conventional surgery|Radical prostatectomy for treatment of prostate cancer
16234578|NCT01126866|Drug|intensified chemotherapy (FOLFOXIRI/Bevacizumab)|intensified chemotherapy (FOLFOXIRI/Bevacizumab)
16234579|NCT01126853|Biological|Twinrix|Up to three intramuscular doses of 1cc of Twinrix (combined hepatitis A/B vaccine) at 0, 1, and 6 months post-enrollment
16234580|NCT01126840|Behavioral|Telephone Interview|The phone interview should take 30-45 minutes to complete.
16234581|NCT01126840|Behavioral|Questionnaire|Mailed questionnaire that contains questions about experiences living with colorectal cancer, take 45-60 minutes to complete.
16234582|NCT01126827|Behavioral|Mindfulness-Based Cognitive Behavioral Therapy or Supportive Psychotherapy|12 weekly group therapy sessions
16234583|NCT01126814|Drug|Imatinib (Gleevec)|
16234584|NCT01126801|Drug|Estradiol|Oral estradiol 1.0 mg/day for four weeks.
16234585|NCT01126801|Other|Placebo control|Placebo control matched to estradiol tablets. Daily dosing for one month.
16234586|NCT01126762|Behavioral|Dietary advice|Dietary advice regarding consumption of low mercury, high DHA fish
16234587|NCT01126762|Behavioral|Control|Advice regarding healthful diet during pregnancy, not focused on fish intake
16234588|NCT01126749|Drug|gemcitabine plus cisplatin|Eribulin Mesylate plus Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin
16234589|NCT01126749|Drug|E7389 in combination with gemcitabine plus cisplatin|Eribulin Mesylate plus Gemcitabine Plus Cisplatin Versus Gemcitabine Plus Cisplatin
16234629|NCT01126437|Drug|tiotropium 2.5 mcg (2 actuations/day)|soft mist inhaler (2 actuations=2 puffs/day)
16234590|NCT01126736|Drug|eribulin mesylate|Eribulin mesylate (eribulin; E7389) administered as a 2-5 minute intravenous (IV) bolus in one of two dosing schedules for both the Phase Ib and Phase 2 portions: either Days 1 and 8 of a 21 day cycle in ascending doses of 0.7, 1.1, or 1.4 mg/m2 or on Day 1 of the 21-day cycle at doses at ascending doses of 0.9, 1.4, or 2.0 mg/m2.
16234591|NCT01126736|Drug|pemetrexed|Pemetrexed given at a dose of 500 mg/m2 as an IV infusion on Day 1 of a 21-day cycle. Patients will also receive dexamethasone and vitamin supplements as recommended in the prescribing information for pemetrexed.
16234592|NCT01126736|Drug|Eribulin mesylate (eribulin; E7389)|Eribulin mesylate (eribulin; E7389) administered as a 2-5 minute intravenous (IV) bolus in one of two dosing schedules for both the Phase Ib and Phase 2 portions: either Days 1 and 8 of a 21 day cycle in ascending doses of 0.7, 1.1, or 1.4 mg/m2 or on Day 1 of the 21-day cycle at doses at ascending doses of 0.9, 1.4, or 2.0 mg/m2.
16234593|NCT01126723|Other|Tai Chi|The Tai Chi intervention will consist of a 12 week, instructor-led, group-based Tai Chi training program (two, one-hour sessions per week).
16234594|NCT01126723|Other|Education-Control|The Education-Control intervention consists of a 12 week, instructor-led attention control program consisting of health education and mind-body breathing exercises (two, one-hour sessions per week)
16234595|NCT01126697|Drug|Coenzyme Q10 and Lisinopril|Arm 1. Coenzyme Q10: taken once a day each morning by mouth OR Arm 2. Lisinopril: taken once a day each morning by mouth OR Arm 3. Coenzyme Q10 and lisinopril: each taken once a day in the morning by mouth OR Arm 4. Enhanced Standard Care (more doctor visits, muscle and breathing testing, and x-rays for monitoring, but no study medication).
16234596|NCT01126684|Drug|Atorvastatin|10 mg of atorvastatin once daily for six months
16234597|NCT01126684|Drug|Placebo|placebo once daily for six months
16234598|NCT01126671|Drug|Supplemental Vitamin D|Subjects were randomized to either take 200 IU of vitamin D or 1000 IU of vitamin D daily for 11 weeks and labs were compared before and after.
16234599|NCT01126658|Other|drainage of cerebrospinal fluid (CSF)|Once the ICP exceed 20-25 mmHg, 1 ml of CSF was withdrawn from EVD and the corresponding change of ICP value was recorded. The withdrawn drainage of CSF continued until the final ICP value declined to 10 mmHg.
16234600|NCT01126645|Procedure|RFA|"A max.of 2 percutaneous RFA sessions is permitted per patient with a max.of 2 liver lesions treated in each RFA session. Randomization to sorafenib or placebo is performed after completion of RFA. Percutaneous RFA is to be performed according to the manufacturer's instructions and following as far as possible routine procedures of the participating hospital. Typically, RFA will be performed under conscious sedation, general anesthesia is permitted. After local anesthesia of the site of puncture, the applicator is positioned in the center of the lesion using ultrasound-, CT- or MR-guidance. The success of ablation is to be controlled directly after RFA using ultrasound, contrast-enhanced CT, or MR imaging. If for any reason RFA is deemed incomplete within the immediate follow-up (up to 2 weeks after the initial ablation), RFA is to be repeated once (in this case, the total (max.) number of RFA sessions will be three).
~The study procedure guide will contain further instructions for RFA."
16234601|NCT01126645|Procedure|Radioembolization (SIRT)|"One SIRT prescription consists of the pre-treatment assessment followed by one or 2 treatment sessions The aim of pre-treatment assessment is to ensure delivery of the microspheres to the target. Evaluation includes a determination of the arterial location and any consequent necessity for coil-embolization of the gastroduodenal artery, right gastric artery and any other accessory arteries to prevent inadvertent administration of microspheres into the gastrointestinal tract or pancreas. In addition, parasitic extrahepatic supply should be coil-embolized.
~Patients in whom the shunt fraction indicates potential exposure to the lung to an absorbed radiation dose of more than 30 Gy should be excluded from treatment with SIR-Spheres. Patients who are randomized to receive SIRT but who are not regarded as eligible for SIRT after the pre-treatment assessment will be switched to the sorafenib only group within the palliative treatment arm."
16234602|NCT01126606|Drug|Dermacid Silver (Lactic acid)|Liquid soap, daily use
16234603|NCT01126606|Drug|Glycerine Vegetal Soap Granado Traditional|Vegetal soap, daily use
16234604|NCT01126593|Drug|0.5% bupivacaine|Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The bupivacaine will have an infusion rate of 4cc an hour.
16234605|NCT01126593|Drug|Normal Saline|The placebo group will receive the same subacromial infusion catheter however, the reservoir will be filled with 200cc of 0.9% Normal Saline.
16234606|NCT01126580|Drug|Metformin|
16234607|NCT01126580|Drug|LY2189265|
16234608|NCT01126580|Drug|Placebo (oral)|
16234609|NCT01126580|Drug|Placebo (subcutaneous)|
16234610|NCT01126567|Other|Sampling Rate|Both cohorts will have a lumbar catheter placed and CSF samples will be obtained. The only difference between the two arms will be the sampling rate of CSF. One arm will have a high sampling rate and the other will have a low sampling rate.
16234611|NCT01126541|Drug|rituximab|Arm A: 1000 mg IV (one infusion) every 2 months \nArm B: 2 x 1000 mg IV (2 infusions) every 2 months
16234612|NCT01126528|Dietary Supplement|Vitamin D3|35,000 IU per week, started at 26-29 weeks gestation, until delivery.
16234613|NCT01126528|Dietary Supplement|Placebo control|Miglyol 812, administered weekly from 26-29 weeks gestation until delivery.
16234614|NCT01126515|Procedure|Magnetic Resonance Imaging|Imaging of the brain without gadolinium will be performed with a 3 Tesla magnetic resonance (MR) System (Intera Achieva 3T; Philips Medical Systems). The protocol will include anatomical sequences, a diffusion tensor imaging sequence with fiber tracking, and auditory, visual, and motor functional magnetic resonance imaging (MRI).
16234615|NCT01126515|Procedure|Computed Tomography Angiography|Computed tomography angiography (CTA) with intravenous (IV) contrast will be performed on a 320 head computed tomography (CT) scanner, assessing brain perfusion.
16234616|NCT01126502|Drug|alvespimycin hydrochloride|Given IV
16234617|NCT01126502|Other|diagnostic laboratory biomarker analysis|
16234618|NCT01126502|Other|pharmacogenomic studies|
16234619|NCT01126502|Other|pharmacological study|
16234620|NCT01126476|Other|Proton Radiotherapy|
16234621|NCT01126463|Drug|188Re-SSS Lipiodol|Hepatic Intra-Arterial Administration of radio-active lipiodol.
16234622|NCT01126450|Drug|lenalidomide|Given orally
16234623|NCT01126450|Biological|cetuximab|Given IV
16234624|NCT01126450|Other|mutation analysis|Correlative studies
16234630|NCT01126424|Drug|Solifenacin|tablet
16234633|NCT01126411|Procedure|immunoadsorption / immunglobulin substitution|Immunoadsorption with protein-A columns on five consecutive days with subsequent human polyclonal immunoglobulin G substitution after day 5 (0,5g /kg bodyweight)
16234634|NCT01126398|Procedure|ankle or distal tibia surgery|internal fixation for ankle or distal tibia fracture
16234635|NCT01126385|Device|DensiProbe Spine|Intraoperative DensiProbe Spine measurements
16234636|NCT01126359|Drug|Lidocaine|Interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge.
16234637|NCT01126359|Drug|Placebo-Saline|Control dressing change: iv or po pain medication and injection of 0.9% normal saline retrograde up the suction tube.
16234638|NCT01126346|Behavioral|HIPEC Orientation|Introduction to SRB (survivorship resource book); Clinic Tour; Lunch with Question and Answer Session
16234639|NCT01126346|Behavioral|Consultation with Survivorship Navigator|Weekly psychosocial support via phone from Survivorship Navigator for 3 weeks prior to HIPEC; Inpatient consults occurring 3 to 4 days post-HIPEC and biweekly for 2 weeks and weekly until hospital discharge; Post-Hospital Discharge consults via phone twice per month for one month
16234640|NCT01126346|Other|Questionnaires|Questionnaires Completed at 4 time points: T1 pre-HIPEC orientation, T2 with in 1 week of orientation, T3 1 month post HIPEC and T4 3 months post HIPEC. Questionnaires include Utility of SRB, Medical Outcomes Study Health Survey, Short Form (SF-12), Center for Epidemiologic Studies-Depression Scale (CES-D), The Brief Illness Perception Questionnaire, The Distress Thermometer, The State-Trait Anxiety Inventory (STAI)
16234641|NCT01126320|Device|AnapnoGuard 100,|Respiratory guard system during mechanical ventilation with routine mechanical ventilator
16234642|NCT01126320|Device|routine mechanical ventilator|routine mechanical ventilation
16234643|NCT01126307|Drug|Verapamil|80 mg tid
16234644|NCT01126307|Drug|placebo|placebo tid
16234645|NCT01126294|Dietary Supplement|5 mg melatonin|Patients will receive 5 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.
16234646|NCT01126294|Dietary Supplement|10 mg melatonin|Patients will receive 10 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.
16234647|NCT01126294|Dietary Supplement|Placebo|Patients will receive placebo once the evening before surgery and then again at 90 minutes before surgery.
16234648|NCT01126281|Procedure|Laparoscopic Cholecystectomy|Laparoscopic cholecystectomy
16234649|NCT01126268|Drug|Retapamulin (Altabax)|Retapamulin ointment, applied topically twice daily for five days
16234650|NCT01126255|Drug|Clobetasol propionate 0.05%|Topical application, once daily about 2 g, during 12 weeks
16234651|NCT01126255|Drug|Progesterone 8%|Topical application, once daily about 2 g, during 12 weeks
16234652|NCT01126242|Device|Tape|Group I will be treated with non-elastic adhesive tape (Leukotape® Classic) around the affected ankle, applied by the 'van Unen-technique'.18 This technique is an alternative for the 'Coumans- technique'.15 The rationale of taping is to take the load off the injured tissue, to correct the biomechanics, to protect the injured part and to enhance proprioception and awareness of the injured tissue. Different materials can be used alone or in combination. The bandage material must have an adhesive layer which allows it to adhere to the skin and to itself. Since the direct stabilizing effect of a bandage lasts no longer than about half an hour, the positive effect is presumed to occur primarily through traction on the skin which stimulates muscular activity.
16234653|NCT01126242|Device|Semi rigid brace|Group II will be treated by application of a semi-rigid brace, the M-step® from Medi®. The foam gel in the pads continuously adapts to give an uninterrupted optimal fit to the constantly changing anatomical conditions, which therefore ensures a uniform compression. The ability of the foam gel pad to adapt allows one orthosis to be used for both the left and the right ankle. The pads are very light and have a soft fleecy surface. Even the edges of the outer moldings are generously padded. The M-step ankle orthosis can be quickly and securely applied by means of two Velcro fasteners; the Velcro fasteners can be detached from the outer shells and fixed individually.
16234654|NCT01126242|Device|Lace-up brace|Group III will be treated by application of a lace-up brace, the ASO brace. The ASO (Ankle Stabilizing Orthosis) fits into an athletic or street shoe. The ASO is made of thin, durable ballistic nylon - the same protective material used by law enforcement and military personnel. Support is achieved through exclusive non-stretch nylon stabilizing straps that mirror the stirrup technique of an athletic taping application. The calcaneus is captured, effectively locking the heel. The ASO ankle brace holds the ankle in a biomechanical neutral position, reducing either inversion or eversion type injuries or re-injuries.
16234655|NCT01126229|Dietary Supplement|Placebo|2 capsules of placebo daily for 12 weeks
16234656|NCT01126229|Drug|Low dose Resveratrol|2 capsules daily for 12 weeks containing 300 mg/d (combined) of resveratrol active ingredient
16234657|NCT01126229|Drug|High dose Resveratrol|2 capsules daily for 12 weeks containing 1000 mg/d (combined) of resveratrol active ingredient
16234658|NCT01126216|Drug|Paclitaxel/Cisplatin|Experimental: Paclitaxel (20mg/m^2/d) on days 2, 5, 8, 11 and 25, 30, 33, 36) and Cisplatin (20mg/m^2/d) on days 1-4 and 29-32,
16234659|NCT01126216|Radiation|Reduced RT|Experimental: 63,6 Gy accelerated hyperfractionated radiotherapy
16234660|NCT01126216|Drug|5-FU/Cisplatin|Active Comparator: 5-Fluorouracil(600mg/m^2/d) on days 1-5 and 29-33) and Cisplatin (20mg/m^2/d) on days 1-5 and 29-33
16234661|NCT01126216|Radiation|Standard RT|Active Comparator: 70,6 Gy accelerated hyperfractionated radiotherapy
16234662|NCT01126203|Procedure|SLT|All eyes will be treated using a commercially available Q-switched Nd:YAG laser (Coherent Selecta 7000, Coherent Inc., Palo Alto , CA, USA) calibrated by the manufacturer. On the day of treatment, IOP will be measured, then one drop of Apraclonidine 1% or Brimonidine 0.2% and pilocarpine 1% or 2% will be instilled. Before the patient is seated at the laser slit-lamp system a proparacaine hydrochloride drop will be instilled in the eye to be treated. A Goldmann goniolens or a Latina SLT or any other goniolens will be placed on the eye to be treated with methyl cellulose 1%. The helium-neon aiming beam is focused onto the pigmented trabecular meshwork. SLT will be performed with approximately 50 applications, a 400um spot size with energies varying from 0.8-1.2 mjoules.
16234697|NCT01125943|Drug|Nitroprusside|Intra arterial infusion
16234698|NCT01125943|Drug|Bevacizumab|Intra arterial infusion
16234738|NCT01125631|Drug|Placebo|Placebo every 8 weeks (4 doses total)
16234785|NCT01125267|Behavioral|multifamily group-standard|multifamily groups held twice a month focused on general problem solving method
16234663|NCT01126203|Procedure|ALT|All eyes will be treated using Ophthalas 532 Eyelite Laser Photocoagulator (Alcon Surgical, Dallas-Fort Worth, Texas, USA. On the day of treatment, IOP will be measured, then on the day of treatment, IOP will be measured, then one drop of Apraclonidine 1% or Brimonidine 0.2% and pilocarpine 1% will be instilled. Before the patient is seated at the laser slit-lamp system a proparacaine hydrochloride drop will be instilled in the eye to be treated. A Goldmann goniolens will be placed on the eye to be treated with methyl cellulose 1%. The aiming beam is focused onto the anterior portion of the pigmented trabecular meshwork. ALT will be performed to the superior or inferior 180 degrees with ~ 50 applications, a 50um spot size with energies varying from 400-700 mW with 0.1 second duration.
16234664|NCT01126190|Biological|Neugranin|Neugranin 40 mg administered approximately 24 hours following chemotherapy for 4 treatment cycles
16234665|NCT01126190|Biological|Pegfilgrastim|Pegfilgrastim 6 mg administered approximately 24 hours following chemotherapy for 4 treatment cycles
16234666|NCT01126190|Drug|Chemotherapy|The chemotherapy regimen for this trial consists of doxorubicin 60 mg/m2 and docetaxel 75 mg/m2 in combination
16234667|NCT01126177|Drug|Interferon beta 1a|SNG001, IFN-β1a solution for inhalation
16234668|NCT01126177|Drug|Placebo|Placebo (excipients of the SNG001 solution only)
16234669|NCT01126164|Behavioral|Parent Handbook and Peer Basics|Parent and Peer delivered interventions
16234670|NCT01126151|Behavioral|parent handbook|parent handbook
16234671|NCT01126138|Drug|Vinorelbine plus Capecitabine for 6 cycles, followed by Capecitabine|Capecitabine: 1,000 mg/m2 PO twice daily (day 1-14) Vinorelbine: 25 mg/m2 IV over 3 hours on day 1 and 8, every 3 weeks 21 days as one cycle and 6 cycles are required
16234672|NCT01126138|Drug|Docetaxel plus Capecitabine for 6 cycles, followed by Capecitabine|"Capecitabine: 1,000 mg/m2 PO twice daily (day 1-14), Docetaxel: 75 mg/m2 IV over 3 hours on day 1, every 3 weeks, 21 days as one cycle and 6 cycles are required.
~Followed by Capecitabine: 1,000 mg/m2 PO twice daily (day 1-14) 21 days as one cycle until progression or unacceptable toxicity"
16234673|NCT01126125|Dietary Supplement|Iodized oil|400 mg of iodine vs 100 mg of iodine as iodized oil
16234674|NCT01126112|Biological|Panitumumab|Panitumumab: 6 mg/Kg Q2W
16234675|NCT01126099|Drug|Prazosin|4 mg capsules twice daily for 12 weeks
16234676|NCT01126099|Drug|Placebo|Placebo capsules twice daily for 12 weeks
16234677|NCT01126086|Drug|otamixaban XRP0673|"Pharmaceutical form: solution for injection
~Route of administration: intravenous"
16234678|NCT01126073|Drug|Niacin/laropiprant|After two weeks patients, who have already been on a stable dose of a statin for at least 6 weeks, willer receive ER niacin/laropiprant in addition to the statin therapy. Patients will receive ER niacin/laropiprant 1000mg/20 mg tablet for 4 weeks, after that the dose will be increased to 2000mg/40mg tablet. The intention is that all patients receive 2000 mg/40mg dose for the rest of the study period, but should they be intolerant to the higher dose, the maximum tolerated dose will be used.
16234679|NCT01126073|Drug|Placebo|After two weeks patients, who have already been on a stable dose of a statin for at least 6 weeks, will receive placebo in addition to the statin therapy. Patients will receive 1 tablet for 4 weeks, after that the dose will be increased to 2 tablets for the rest of the study period.
16234680|NCT01126060|Drug|Usage of Fibrin sealant|Usage of 1 vial of fibrin sealant after hemostasis in total thyroidectomy with anterior compartment neck dissection
16234681|NCT01126060|Procedure|Thyroidectomy|surgical removal of bilateral thyroid glands
16234682|NCT01126047|Other|eCO testing|exhaled carbon monoxide testing measured in duplicate on each of 2 machines immediately prior to the carboxyhemoglobin blood draw and four minutes after the clinical measurement of DLCO
16234683|NCT01126034|Other|intervention letter|"Physicians in the intervention group were mailed a written feedback letter regarding their patients who were prescribed questionable metoclopramide therapy. Non-intervention providers received no letter. The letter consisted of the following components:
~The name and medical record # of the patients involved
~Information regarding the metoclopramide prescription: dates, dosage, indication recorded, and the duration of therapy
~A reminder of the adverse effect of long-term metoclopramide therapy
~A recommendation to consider having the patient undergo a trial of metoclopramide discontinuation if appropriate, and documentation of a discussion of risk and benefits of metoclopramide therapy with patients
~A request that the physician document the discontinuation trial in the electronic medical record"
16234684|NCT01126021|Behavioral|Financial incentives|Participants are eligible for incentives if they participate in at least 30 games per day.
16234685|NCT01126021|Behavioral|No incentives|Participants will be given training and access to the software to participate in mental exercises but will not be given financial incentives for participation.
16234686|NCT01126008|Drug|CCRT with weekly docetaxel & cisplatin|radiotherapy: 70Gy/35 fraction for 7 weeks chemotherapy: docetaxel 20mg/m2 and cisplatin 20mg/m2 weekly for 6 weeks
16234687|NCT01125995|Radiation|early CCRT|"patients will be received with 4 cycles of etoposide 100mg/m2 D1-3 & Cisplatin 70mg/m2 D1.
~radiotherapy start from day 1 of 1st chemotherapy cycle and complete 5250cGy/25fraction (daily one fraction, 210cGy)."
16234688|NCT01125995|Radiation|late CCRT|"patients will be received with 4 cycles of etoposide 100mg/m2 D1-3 & Cisplatin 70mg/m2 D1.
~radiotherapy start from day 1 of the third cycle of EP chemotherapy and complete 5250cGy/25fraction (daily one fraction, 210cGy)."
16234689|NCT01125982|Drug|Propofol|Continuous intravenous infusion at 3-6 µg/mL (Ce - Target Controlled Infusion) during anaesthesia to provide sleep.
16234690|NCT01125982|Drug|Desflurane|Continuous inhalation at 0.7-0.8 MAC (endtidal) during anaesthesia to provide sleep
16234691|NCT01125969|Behavioral|Incentives|Incentives will be offered for checking blood glucose each morning and for control of blood glucose (between 80-140 mg/dL).
16234692|NCT01125969|Behavioral|Education|Standard brochure about improving blood sugar control plus warnings about dangers of persistently high sugars and hypoglycemia
16234693|NCT01125969|Behavioral|Peer mentoring|Participant is assigned a peer mentor who is matched on gender, race and age and who achieved good glucose control after previously having poor glucose control.
16234694|NCT01125956|Behavioral|Assigned a peer counselor|Dyads will be given $20 per month if they have contact 4 or more times during a month.
16234695|NCT01125956|Behavioral|Financial incentives|Participants will be given $100 for reduction of HbA1c by 1 point in a 6 month period and $200 for reduction by 2 points.
16234696|NCT01125943|Drug|Acetylcholine|Intra-arterial infusion
16234699|NCT01125930|Drug|vehicle gel|Topical gel that does not contain active drug. The gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use.
16234700|NCT01125930|Drug|Atralin gel|Topical Atralin gel will be applied initially 3 times per week to the face. If no irritation seen at follow up visit, the investigator will consider increasing the frequency of use. This topical medication will not be applied more than once daily. If there is irritation, the subject will be asked to decrease frequency of use. This drug will be used for the duration of the study.
16234701|NCT01125917|Drug|Buprenorphine transdermal patch|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear.
16234702|NCT01125917|Drug|Buprenorphine transdermal patch|Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear.
16234703|NCT01125917|Drug|Buprenorphine transdermal patch|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear.
16234704|NCT01125904|Drug|crizotinib|Oral liquid. Taste assessment of new formulation. Subjects will not ingest the drug.
16234705|NCT01125891|Drug|gemcitabine|The dose of gemcitabine will be fixed at 1000 mg/m2 i.v. as a 30 minutes infusion on days 1, 8, and 15 every 28 days.
16234706|NCT01125891|Drug|ON 01910.Na|The starting dose of ON 01910.Na is 600 mg/m2 as a 2 hour intravenous (i.v.) infusion on days 1, 4, 8, 11, 15 and 18 of a 28-day course. The dose of ON 01910.Na will be escalated in increments in successive cohorts (dose level (DL) 1 = 600 mg/m2, DL 2 = 1200 mg/m2, DL 3 = 1800 mg/m2) of new patients.
16234707|NCT01125878|Dietary Supplement|Placebo|placebo
16234708|NCT01125878|Dietary Supplement|Starch composite B|fiber mixture
16234709|NCT01125878|Dietary Supplement|Starch composite C|fiber mixture
16234710|NCT01125878|Dietary Supplement|Starch composite D|fiber mixture
16234711|NCT01125865|Device|SEMS insertion|Self-expandable metallic stent will be inserted for malignant hilar obstruction.
16234712|NCT01125865|Device|DLS insertion|DoubleLayer plastic stent will be inserted for malignant hilar obstruction.
16234713|NCT01125852|Procedure|Angiographic embolization|Patients in the intervention arm receive supplementary angiographic embolization within 24 hours from the therapeutic endoscopy.
16234714|NCT01125852|Procedure|Therapeutic endoscopy|Patients are treated with standard therapeutic upper endoscopy including endoscopic combination therapy.
16234715|NCT01125813|Biological|recombinant Factor VIII|intravenous infusion of factor FVIII every other day.
16234716|NCT01125800|Drug|LDE225|LDE225/sonidegib capsules were supplied to the Investigators at dose strengths of 50 mg, 100 mg, 200 mg, and 250 mg.
16234717|NCT01125787|Drug|ofatumumab + bendamustine|Loading dose of ofatumumab at 300mg IV with subsequent doses at 100mg IV on D1 of all cycles (maximum of 6 cycles) in combination with bendamustine 90mg/m2 on day 2 of all cycles. Neulasta 6mg SQ will also be given on day 8 of cycle 1 only.
16234718|NCT01125774|Drug|Telcagepant|Telcagepant 140 mg film coated tablet for oral administration
16234719|NCT01125774|Drug|Placebo|Placebo to match telcagepant 140 mg film coated tablet for oral administration
16234720|NCT01125761|Drug|dexamethasone 0.5 mg and 1.0 mg clemastine cream|The treatment should be administered every 12 hours so that a thin layer is applied on the lesions, for 14 days.
16234721|NCT01125761|Drug|Dexamethasone 0,5 mg cream|The treatment should be administered every 12 hours so that a thin layer is applied on the lesions, for 14 days.
16234722|NCT01125748|Drug|Omalizumab|Omalizumab was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that was reconstituted with sterile water for injection.
16234723|NCT01125748|Drug|Placebo|Placebo contained the same ingredients as the omalizumab formulation, excluding omalizumab.
16234724|NCT01125748|Drug|Asthma therapies|Participants could receive 1 or more of the following medications as concomitant asthma therapy: Inhaled corticosteroids; long acting beta-agonists; zafirlukast or other leukotriene receptor antagonist; zileuton or other 5-lipoxygenase enzyme inhibitors; oral, inhaled, and/or nasal anticholinergic therapy; mast-cell stabilizers; theophyllines; chronic oral corticosteroids, defined as a minimum dose of oral prednisone of 2 to 40 mg/day or 5 to 80 mg every other day.
16234725|NCT01125735|Device|MIST Therapy|The MIST Therapy System is designed to deliver therapeutic ultrasound to the wound bed without direct contact of the device to the body (noncontact). The system generates and propels the therapeutic MIST Therapy towards the tissue. The saline solution is directed to the tip surface and is atomized through the vibration of the tip surface. This surface creates atomization of the fluid, breaking it apart into small particles of uniform size. Once the particles of fluid are released from the tip, a second phenomenon, the acoustic pressure wave, drives them toward the wound.
16234726|NCT01125735|Other|Standard of Care|Standard of Care with saline rinse using a sham device which is a nebulizer compressor designed to deliver a continuous saline mist to a skin treatment site. The saline mist generated has been designed to be comparable to that delivered by the MIST Therapy System, but without the ultrasound waves.
16234727|NCT01125722|Device|Non-invasive neurostimulation device|Active electrode patches are worn for 4 weeks, one per week, during the treatment phase of the study. The patch is placed by the investigator.
16234728|NCT01125722|Device|Non-invasive neurostimulation device|Active electrode patches are worn for 4 weeks, one per week, during the treatment phase of the study. The patch is placed by the subject.
16234729|NCT01125696|Drug|Tenofovir/lamivudine/lopinavir-ritonavir|Tenofovir/lamivudine/lopinavir-ritonavir given to mothers starting at 14-28 weeks gestation till labor/delivery and continued postpartum if maternal baseline CD4<350
16234730|NCT01125696|Drug|Zidovudine/lamivudine/lopinavir-ritonavir|Zidovudine/lamivudine/lopinavir-ritonavir given to mothers starting at 14-28 weeks gestation till labor/delivery and continued postpartum if maternal baseline CD4<350
16234731|NCT01125683|Drug|AZD1446|Capsule, oral single and multiple dose
16234732|NCT01125683|Drug|Donepezil|Capsule, oral and single dose
16234733|NCT01125683|Drug|Placebo|Capsule, oral and single dose
16234734|NCT01125670|Drug|YM150|oral
16234735|NCT01125657|Drug|YM150|oral
16234736|NCT01125644|Drug|SPK-843|SPK-843 is a semi-synthetic substance derived from Partricin A. 05 mg/Kg solution of SPK-843 in 10% intralipid will be administered i.v. in a hour for a treatment of 14 days
16234737|NCT01125631|Biological|PF-04360365 8.5 mg/kg|8.5 mg/kg every 8 weeks (4 doses total)
16234739|NCT01125618|Other|Health and development intervention package|The timing and sequence of intervention vary by site, but include improved access to seed-fertilizer to increase agricultural production; improved market and capital access; proven maternal-newborn-child health interventions delivered free of cost at the point of service; improvements to school number and quality; and access to basic infrastructure including safe water, sanitation, electricity, transport and communication.
16234740|NCT01125618|Other|Routine services|Routine services and programs currently being administered using prevailing resources, at the current pace and with established partnerships. There is no attempt to limit the introduction of new interventions or agencies into comparison sites.
16234741|NCT01125592|Device|IonCLeanse Footbath|Application of an ionic footbath for 30 minutes per week for 4 weeks
16234742|NCT01125566|Drug|BIBW 2992|patients receive BIBW 2992 tablets once daily and can reduce dose for adverse event management
16234743|NCT01125566|Drug|trastuzumab|patients receive trastuzumab 2mg/kg intravenously every week
16234744|NCT01125566|Drug|vinorelbine|patients receive vinorelbine 25mg/m² intravenously every week
16234745|NCT01125566|Drug|vinorelbine|patients receive vinorelbine 25mg/m² intravenously every week
16234746|NCT01125553|Drug|insulin degludec/insulin aspart|Each subject will be allocated to two single injections of trial product on two separate dosing visits with each of the two insulin degludec/insulin aspart formulations. The trial products will be administered as a subcutaneous injection (under the skin).
16234747|NCT01125540|Device|Acuvue (Standard Daily Disposable Contact Lens)|
16234748|NCT01125540|Device|CIBA Dailies Aquacomfort Plus (Contact Lens - enhance lubricating)|
16234749|NCT01125527|Biological|Monovalent glyco-conjugated vaccine against Haemophilus influenzae type b (Hib)|a single dose was administered
16234750|NCT01125527|Biological|Tetanus toxoid polysaccharide-conjugated vaccine against Haemophilus influenzae type b (Hib)|a single dose was administered
16234751|NCT01125514|Drug|Aliskiren 150 mg|Aliskiren 150 mg tablet
16234752|NCT01125514|Drug|Furosemide 60 mg|Furosemide 60 mg commercially-available tablets
16234753|NCT01125514|Drug|Placebo for Aliskiren|Matching placebo for aliskiren 150 mg and 300 mg
16234754|NCT01125514|Drug|Aliskiren 300 mg|Aliskiren 300 mg tablet
16234755|NCT01125501|Dietary Supplement|Protandim|The product Protandim used in this study have ingredients derived from five botanical sources [Bacopa monniera, Silybum marianum (milk thistle), Withania somnifera (Ashwagandha), Camellia sinensis (green tea), and Curcuma longa (turmeric)].
16234756|NCT01125488|Device|LNG-IUS|levonorgestrel-releasing intrauterine system (LNG-IUS) 52mg, duration 5 years
16234757|NCT01125488|Drug|GnRH agonist (triptorelin)|GnRH agonist (triptorelin 3.75 mg, sc q28day)
16234758|NCT01125475|Device|RebiSmart|Treatment with Rebif New Formulation using RebiSmart.
16234759|NCT01125462|Other|Quality of Life Questionnaire (FertiQoL)|Subjects will be administered the first internationally validated Quality of Life questionnaire (FertiQoL) to assess the quality of life of infertile subjects.
16234760|NCT01125449|Drug|Ascorbic acid (vitamin C)|Intravenous administration of up to 1.5gm/kg of ascorbic acid, twice weekly for up to 12-weeks.
16234761|NCT01125436|Dietary Supplement|Cholecalciferol|50,000 IU weekly for 6 months
16234762|NCT01125436|Dietary Supplement|Cholecalciferol|Placebo weekly for 6 months
16234763|NCT01125423|Drug|Milnacipran|Subject with Fibromyalgia will then be titrated onto milnacipran over 8 days to subject reported optimal pain control or a maximal dose of 100mg/day per package insert. Subjects will be permitted to increase or decrease their dosing at any time during the study per MD discretion in order to maintain optimal pain control.
16234764|NCT01125423|Procedure|Skin biopsy|Subjects with Fibromyalgia will have 3 mm skin biopsies obtained from the dominant trapezius and the glabrous hypothenar area of the hand.
16234765|NCT01125423|Procedure|Skin Biopsy|Control Subjects will have 3 mm skin biopsies obtained from the dominant trapezius and the glabrous hypothenar area of the hand.
16234766|NCT01125410|Drug|Dequalinium chloride|Vaginal tablet, 10mg, 1 tablet daily for 6 days
16234767|NCT01125410|Drug|Clindamycin|vaginal cream, 2%, once daily for 7 days
16234768|NCT01125397|Behavioral|LEARN group|Participants will complete a 12-week behavioral weight management intervention (the LEARN program) prior to bariatric surgery, which is the current standard clinical practice at Mayo Clinic Rochester. This involves weekly group meetings, weigh-ins, and goal setting.
16234769|NCT01125384|Other|additional swabbing|physician swabs patient's throat according to standard rules before referral of the patient to throat swabbing by nurse.
16234770|NCT01125371|Behavioral|Computerized brief alcohol intervention + IVR booster calls|1) Computerized brief alcohol intervention + IVR booster calls: Clinic-based computerized brief alcohol intervention (delivered once) followed by three booster phone calls using interactive voice response technology + text messages
16234771|NCT01125371|Behavioral|Computerized brief alcohol intervention|Computerized brief alcohol intervention: Clinic based computer delivered brief alcohol intervention delivered one time
16234772|NCT01125371|Behavioral|Attention Control|Attention Control: 20 minute attention control condition focused on dental hygiene delivered once
16234773|NCT01125358|Drug|LY2140023|Administered orally, twice daily for up to 7 weeks of treatment
16234774|NCT01125358|Drug|Placebo|Administered orally, twice daily for up to 7 weeks of treatment
16234775|NCT01125345|Procedure|Phacoemulsification|Phacoemulsification with IOL implantation in eyes undergoing bilateral cataract surgery
16234776|NCT01125332|Drug|Indirect laryngoscopy in the flexible nasofibroscope|
16234777|NCT01125332|Drug|Indirect laryngoscopy in the flexible nasofibroscope|
16234778|NCT01125319|Other|blood sample|
16234779|NCT01125306|Device|Xal-Ease|Xal-Ease device used to facilitate application of Xalatan/Xalacom eye drops.
16234780|NCT01125293|Drug|Everolimus|
16234781|NCT01125293|Drug|Rituximab|
16234782|NCT01125293|Drug|Bortezomib|
16234783|NCT01125280|Procedure|Conservative treatment versus surgical treatment|Conservative treatment: starving, nasogastric tube Surgical treatment: open laparotomy, adhesiolysis, with or without small bowel resection
16234784|NCT01125267|Behavioral|multifamily group-adherence|multifamily groups held twice a month for one year focused on improving medication adherence using techniques derived from the Theory of Planned Behavior
16234786|NCT01125254|Drug|Amlodipine|5mg po for 12 months
16234787|NCT01125241|Drug|wuling capsule|orally, three tablets each time,three times a day
16234788|NCT01125241|Drug|placebo of wuling capsule|orally, three tablets each time and three times a day
16234789|NCT01125215|Drug|0.75% capsaicin nanoparticle cream|0.75% capsaicin nanoparticle cream apply to area with neuropathic pain twice daily for 12 weeks
16234790|NCT01125215|Drug|Placebo|Identical cream base of nanoparticle apply to area with neuropathic pain twice daily for 12 weeks
16234791|NCT01125202|Behavioral|SCT-based behavioral intervention|Intervention group continues to receive routine dialysis care. The intervention duration is 16 weeks. Intervention contacts are 2x/week for weeks 0-8, weekly for weeks 9-12, and every other week for weeks 13-16. Personal digital assistant dietary records are use to provide targeted counseling and engaged the participant in problem solving around dietary issues.
16234792|NCT01125202|Behavioral|Attention Control|Attention control participants continue to receive routine dialysis care. Attention control participants view 5 computerized educational programs PowerPoint slides) that summarize the various elements of the HD diet. The 5 modules evenly over the 4-month study period.
16234793|NCT01125189|Drug|Daclatasvir|Tablets, oral, 20 mg, once daily, 12-24 weeks, depending on response
16234794|NCT01125189|Drug|Daclatasvir|Tablets, oral, 60 mg, once daily, 12-24 weeks, depending on response
16234795|NCT01125189|Drug|Placebo|Tablets, oral, 0 mg, once daily, 24 weeks
16234796|NCT01125189|Drug|peg-interferon alfa-2a|Syringe, subcutaneous Injection, 180 µg, once weekly, 24 or 48 weeks depending on response
16234797|NCT01125189|Drug|ribavirin|Tablets, oral, 1000 or 1200 mg based on weight, once daily, 24 or 48 weeks depending on response
16234798|NCT01125176|Drug|thalidomide|50 mg oral dosing every other day
16234799|NCT01125176|Drug|lenalidomide|varying oral doses every other day (max 25 mg/day)
16234800|NCT01125176|Biological|rituximab|375 mg/m2 intravenously on days 1, 8, 15, and 22 of cycle 1. Then, repeated on days 1, 8, 15, and 22 of every 6th cycle thereafter (Cycle 7, 13, 19, etc.)
16234801|NCT01125163|Dietary Supplement|Iron Supplement|multivitamin that provides 2mg/kg/day of iron given orally to infants when they are tolerating 120 ml/dg/day of preterm formula or fortified breast milk until they reach 36 weeks adjusted postmenstrual age.
16234802|NCT01125163|Dietary Supplement|multivitamin|daily oral multivitamin without iron until 36 weeks adjusted postmenstrual age
16234803|NCT01125150|Drug|Metformin|Dosage to be determined by Endocrinologist
16234804|NCT01125150|Behavioral|Dietary Modification|To be determined by Endocrinologist
16234805|NCT01125137|Procedure|Removal of Keloid|Keloid will be excised by Henry Ford Hospital Dermatologist, Dermatosurgeon or Plastic Surgeon.
16234806|NCT01125124|Drug|Silver Nitrate|Instilation of silver nitrate solution through the pleural catheter. The catheter remains closed for 1h after the procedure and is then reopened. There will be 3 different dosages, corresponding to the 3 different arms.
16234807|NCT01125111|Procedure|surgery(robot versus laparoscopy)|
16234808|NCT01125098|Other|PRO-CT values|"continue antibiotics for 10 days if a single PRO-CT value is 0.25 mcg/L or greater, that will be judged suggestive of bacterial infection
~continue antibiotics from day 3 to day 10 if one or more PRO-CT values are 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, PLUS acute respiratory failure or clinical instability
~stop antibiotics on day 3, if one or more PRO-CT values are between 0.1 to 0.25 mcg/L, indicative of possible bacterial infection, BUT the patient has not acute respiratory failure or clinical instability
~stop antibiotics if all the PRO-CT values are < 0.1 mcg/L or if there is a consistent trend to normalization of PRO-CT with the last value < 0.1 mcg/L, that will be judged suggestive of absence of bacterial infection."
16234809|NCT01125085|Radiation|131I-L19SIP Radioimmunotherapy (RIT) in Combination With Whole Brain Radiation Therapy (WBRT)|"Patients will be treated with WBRT administering a total dosage of 30 Gy in fractions of 3 Gy
~Dosimetric evaluation with 131I-L19SIP or 124I-L19SIP will be performed to assess eligibility for RIT.
~Patients eligible for RIT will receive a therapeutic dose of 131I-L19SIP.
~Total treatment duration is up to 4 weeks"
16234810|NCT01125072|Other|Echocardiography with strain analysis|Clinical routine echocardiogram with additional off line strain analysis
16234811|NCT01125059|Drug|Methadone|0.2 mg/kg methadone IV bolus
16234812|NCT01125059|Drug|Saline|3 mL saline IV bolus
16234813|NCT01125046|Biological|bevacizumab|Given IV
16234814|NCT01125033|Drug|Vitamin C & Vitamin E|The patients in this arm received one tablet of vitamin C (200 mg) and one capsule of vitamin E (400 mg) daily for 8 weeks
16234815|NCT01125033|Drug|Vitamin C|The patients in this arm received one tablet of vitamin C (200 mg) and one placebo capsule daily for 8 weeks.
16234816|NCT01125033|Drug|Vitamin E|The patients in this arm received one capsule of vitamin E (400 mg) and one placebo tablet daily for 8 weeks.
16234817|NCT01125033|Drug|Vitamin C Placebo & Vitamin E Placebo|The patients in this arm received one placebo capsule and one placebo tablet daily for 8 weeks.
16234818|NCT01125020|Drug|gemcitabine and oxaliplatin|Gemcitabine 1000mg/m2 (days l, 8) and oxaliplatin 130mg/m2 (day l) delivered as an intravenous infusion, given every 28days and repeat six times.
16234819|NCT01125020|Drug|doxorubicin, 5-Fu and cisplatin|Doxorubicin 20mg/m2 (days 1, 3), 5-Fu 300mg/m2 (days 1-5) and cisplatin 20mg/m2 (days 1-3) delivered as an intravenous infusion, given every 28days and repeat six times.
16234820|NCT01125007|Device|Two kind toothbrushes|a randomization was performed in which the participants were allocated to the following experimental procedures: Two quadrants (1 and 3 or 2 and 4) with medium toothbrush Two quadrants with soft toothbrush. All procedures were performed using the same dentifrice. Each quadrant was brushed for 30 seconds by the participant without specific instructions on the technique, under supervision of the person in charge of the randomization.
16234821|NCT01124994|Procedure|Endoscopic mucosal resection|Confocal laser endomicroscopy will be used to target endoscopic mucosal resection of Barrett's oesophagus-associated neoplasia
16234822|NCT01124981|Drug|Haemocomplettan® P|Dosing of study medication will be individually determined based on plasma fibrinogen concentrations (measured with Clauss method during the reperfusion period on CPB) and body weight. Intravenous infusion within 10 minutes.
16234823|NCT01124981|Drug|Human albumin (Placebo)|Human albumin with concentration 200g/L. The study bottles of 50 mL will be diluted with saline and will contain 2g in total. This concentration resembles the total protein load in the bottles with Haemocomplettan® P.
16234867|NCT01124682|Radiation|3-dimensional conformal radiation therapy|
16234824|NCT01124968|Other|eConsulta|It is a web specifically designed for the project where elected patients can consult virtually with their primary care physician and within 48 hours have an answer.
16234825|NCT01124955|Other|Acupuncture|The intervention group (IG) are submitted to five acupuncture sessions using Yamamoto New Scalp Acupuncture(YNSA)
16234826|NCT01124955|Other|Non-penetrating acupuncture|The placebo group (PG) are submitted to five non-penetrating acupuncture sessions using YNSA.
16234827|NCT01124942|Device|MGuard net protective coronary stent|It is a new closed-cell design stent concept. with an ultra-thin flexible polyethylene terephthalate (or Dacron) mesh sleeve, anchored to the external surface of the struts. This net (string diameter 10-22 μm) minimally affects stents' trackability and deliverability. During stent deployment, the net stretches and slides over the expanding stent struts, trapping the thromboembolic debris underneath the fiber net.
16234828|NCT01124942|Device|Bare-metal stent and manual thrombectomy device|Manual thrombectomy device as an adjunctive strategy for conventional stenting with a bare-metal stent
16234829|NCT01124929|Drug|RNTCP Category I treatment for 6 months|2H3R3Z3 E3 + 4H3R3
16234830|NCT01124929|Drug|RNTCP Category I treatment for 9months|2H3R3Z3 E3 + 7H3R3
16234831|NCT01124916|Procedure|Robotic assisted laparoscopic abdominal sacrocolpopexy|Robotic assisted laparoscopic abdominal sacrocolpopexy for surgical repair of pelvic organ prolapse.
16234832|NCT01124916|Procedure|Standard laparoscopic abdominal sacrocolpopexy|Standard laparoscopic abdominal sacrocolpopexy for surgical repair of pelvic organ prolapse.
16234833|NCT01124903|Procedure|Dehydration|Subjects were dehydrated by 2 - 7% of body mass over 3-5 hours using exercise-heat stress and fluid restriction.
16234834|NCT01124890|Device|percutaneous coronary intervention|
16234835|NCT01124877|Drug|ziprasidone oral capsules|Oral ziprasidone capsules of 20 mg, 40 mg, 60 mg, and 80 mg strength will be provided. Subjects will be dosed daily for 26 weeks using a flexible dose design with a minimal dose range of 40mg twice a day (BID) to a maximum dose range of 80 mg BID. For subjects weighing <45 kg, the doses will range from 20 mg BID to 40 mg BID.
16234836|NCT01124864|Drug|AUY922|AUY922 was supplied in individual 10 mL amber colored glass ampoules containing 10 mL of a 5 mg/mL active drug substance in 5% aqueous glucose solution. AUY922 was administered intravenously (i.v.) weekly at 70 mg/m2.
16234837|NCT01124851|Drug|ABT-652|See arm description for details
16234838|NCT01124851|Drug|Placebo|See arm description for details
16234839|NCT01124838|Drug|Adalimumab|Administered subcutaneously as an 80 mg loading dose (2 syringes) at Baseline followed by 40 mg eow starting at Week 1.
16234840|NCT01124838|Drug|Prednisone|Administered orally, 10 - 35 mg/day at study entry followed by a protocol-defined mandatory taper schedule in which all subjects continuing in the study were to discontinue prednisone no later than Week 19.
16234841|NCT01124838|Drug|Placebo|Administered by subcutaneous injection
16234842|NCT01124825|Device|IGEL|iGEL(TM) airway will be used for induction and maintenance of positive pressure ventilation
16234843|NCT01124825|Device|King airway|KING-LTS-D(TM) airway will be used for induction and maintenance of positive pressure ventilation
16234844|NCT01124812|Other|131I-L19SIP Radioimmunotherapy (RIT) in Combination With External Beam Radiotherapy (EBRT) and Concurrent Chemotherapy|"Lung tumor irradiation with a total dosage of between 60-66 Gy, fractionated in combination with the following concurrent chemotherapy options:
~Cohorts 1, 2 & 3a is composed of cisplatin i.v. 80 mg/m2 on day 1, and vinorelbine i.v. 25 mg/m2 on day 1, 8, 15 for cycle 1 & 4. For patients with significant comorbidities, the dose of vinorelbine is reduced to 12.5 mg/m2 during cycles 2 & 3. Treatment cycles will be repeated every 28 days.
~Protocol A (suggested for patients with comorbidities: Carboplatin 70 mg/m2, over 30 min iv, (Day 1-5 ) + Vinorelbine 12.5 mg/m2 as a 5-min bolus iv or short iv-infusion (Day 1, 8, 22), repeated on Day 28.
~Protocol B (suggested for patients in good clinical condition): Paclitaxel 50 mg/m2 1 hour iv (Day 1, 15, 22, 29, 36, 43, 50) + Carboplatin AUC 2, 30 min iv on (Day 1, 15, 22, 29, 36, 43, 50).
~Total treatment duration is 8-16 weeks"
16234845|NCT01124799|Drug|TMC435|one morning TMC435 dose between 75 and 150 mg and a placebo dose at noon and in the evening, for 9 days
16234846|NCT01124799|Drug|Placebo|placebo dose in the morning, at noon and in the evening, for 9 days
16234847|NCT01124799|Drug|Ciprofloxacin|one morning placebo dose and a noon and evening dose of ciprofloxacin 500 mg, for 9 days
16234848|NCT01124786|Drug|CO-1.01|1250 mg/m2 intravenous infusion weekly for 3 weeks every 4 weeks
16234849|NCT01124786|Drug|Gemcitabine|1000 mg/m2 intravenous infusion weekly for 7 weeks followed by 1 week rest, then weekly for 3 weeks every 4 weeks
16234850|NCT01124760|Drug|AZD9742|Sterile solution, 620 mg (20 mg/mL) in 50 mL vial with a fill volume of 31 mL; On Day 7, a single 150 mg IV dose, coadministered after the morning dose of ketoconazole
16234851|NCT01124760|Drug|Diltiazem|Orally, daily beginning on Day 4 for 14 consecutive days
16234852|NCT01124760|Drug|ketoconazole|200 mg, orally, every 12 hours starting on Day 4 for 10 consecutive days in which on Day 13 only the morning dose will be administered
16234853|NCT01124747|Drug|ASP1585|Oral
16234854|NCT01124747|Drug|14C-Labeled ASP1585|Oral
16234855|NCT01124734|Drug|Interleukin-2|Participants will receive IL-2 up to a maximum of 14 doses at 600,000 IU/kg
16234856|NCT01124734|Drug|Temozolomide|Participants receive temozolomide at 75 mg/m2 after completion of the second cycle of high dose IL-2. Participants take the medication at bedtime daily. Four weeks after Cycle 2 of a course, they would take it for 21 days.
16234857|NCT01124721|Behavioral|Cognitive training|Cognitive computerized training for several days per week.
16234858|NCT01124721|Behavioral|Cognitive training-placebo|Cognitive training that only minimally increases in difficulty
16234859|NCT01124708|Drug|TC-5619-238|TC-5619-238 will be provided as white, opaque gelatin capsules in strengths of 1mg, 5mg, and 25mg (as free base). Subjects will take 1mg TC-5619, 5mg TC-5619, 25mg TC-5619, or matching placebo - one capsule once daily p.o.
16234860|NCT01124708|Drug|Placebo|Placebo will be provided as white, opaque gelatin capsules in sham strengths of 1mg, 5mg, and 25mg
16234861|NCT01124695|Drug|tamoxifen citrate|
16234862|NCT01124695|Other|laboratory biomarker analysis|
16234863|NCT01124682|Procedure|diagnostic cystoscopy|
16234864|NCT01124682|Procedure|diffusion-weighted magnetic resonance imaging|
16234865|NCT01124682|Procedure|implanted fiducial-based imaging|
16234866|NCT01124682|Procedure|quality-of-life assessment|
16234868|NCT01124682|Radiation|image-guided radiation therapy|
16234869|NCT01124682|Radiation|selective external radiation therapy|
16234870|NCT01124669|Genetic|DNA analysis|
16234871|NCT01124669|Genetic|mutation analysis|
16234872|NCT01124669|Other|laboratory biomarker analysis|
16234873|NCT01124656|Drug|Pioglitazone-Azilsartan|Pioglitazone-Azilsartan (30 mg + 20 mg) or (45 mg + 20 mg), tablets, orally, once daily for up to 52 weeks.
16234874|NCT01124643|Biological|Replagal|0.2 mg/kg administered intravenously [IV] every other week
16234875|NCT01124630|Drug|CS-1008|CS-1008 will be administered IV each week. The initial/loading dose (6 mg/kg) will be administered Day 1 of Cycle 1. Maintenance doses of 2 mg/kg will be administered weekly thereafter.
16234876|NCT01124630|Drug|FOLFIRI|The FOLFIRI regimen will be administered IV at Weeks 1 and 3 of each 4 week cycle, and it will begin at Week 1 of Cycle 1. It will comprise irinotecan, 180 mg/m2 IV infusion over 30 to 120 minutes; leucovorin, 400 mg/m2 IV infusion to match the duration of the irinotecan infusion; and 5-FU, 400 mg/m2 (bolus) followed by 1200 mg/m2/day x 2 days (total 2400 mg/m2 over 46 to 48 hours continuous infusion).
16234877|NCT01124617|Drug|Tapentadol|Tapentadol hydrochloride extended-release(ER) will be administered as oral tablet at dose ranging from 25 milligram (mg) to 250 mg twice daily for 12 weeks.
16234878|NCT01124617|Drug|Placebo|Matching Placebo will be administered as oral tablet at dose ranging from 25 mg to 250 mg twice daily for 12 weeks.
16234879|NCT01124604|Drug|Tapentadol Hydrochloride|Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) will be administered orally twice daily for 12 weeks. Dose will be adjusted as per Investigator's discretion.
16234880|NCT01124604|Drug|Placebo|Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg will be administered orally twice daily for 12 weeks. Dose will be adjusted as per Investigator's discretion.
16234881|NCT01124591|Behavioral|Brief motivational intervention|two session delivered two weeks apart
16234882|NCT01124565|Drug|RT001|RT001 (Botulinum Toxin Type A Topical Gel, Dose A) at Baseline (Day 0) and Week 4 to the lateral canthal areas
16234883|NCT01124552|Drug|RT001 Botulinum toxin type A (Dose A)|RT001 Botulinum Toxin Type A (Dose A)
16234884|NCT01124552|Drug|RT001 Botulinum Toxin Type A (Dose B)|RT001 Botulinum Toxin Type A (Dose B)
16234885|NCT01124552|Other|Vehicle|Vehicle Control
16234886|NCT01124552|Drug|Placebo|Placebo Comparator
16234887|NCT01124539|Drug|AR-67 (7-t-butyldimethylsiltyl-10-hydroxy-camptothecin)|IV AR-67 administered once daily for 5 days on an every 21-day cycle
16234888|NCT01124526|Drug|Rituximab Fludarabine Cyclophosphamide|"Patients receiving from 4 to 6 cycles of chemotherapy (R F C) each 4 weeks depending on haematological tolerance:
~RITUXIMAB(R)375 mg/m2 iv,day 3 C1 and day 1 C2-C6,(total dose 375 mg/m2) FLUDARABINE(F):25 mg/m2 iv, day 1-3,(total dose 75 mg/m2) CICLOPHOSPHAMIDE(C)1000 mg/m2 iv, day 1,(total dose 1000 mg/m2)"
16234889|NCT01124513|Procedure|Induced Erythema|Study personnel will induce erythema by sequentially applying ice for approximately 2 minutes to the 2 cm^2 target region of the upper volar arm. This erythema is a reaction to the vasoconstriction caused by skin cooling. The vasoconstriction is visually monitored to determine the onset of the vascular dilation that occurs after cessation of cooling. Images with the Digital Camera, Spectrophotometer and Videodermoscope are re-taken.
16234890|NCT01124500|Drug|methylphenidate via transdermal patch compared to placebo|The participants will start with a 10mg MPH patch on day -4, the 1st day of the titration period. This will be increased up to 20mg over 4-day titration period as needed and tolerated, and continued on the optimal dose. Subjects will be seen on day 1 of the double-blind part of the study at a patient education room or the Dr.'s office and receive 10 identical patches including 5 MPH and 5 placebo patches that will be randomly assigned over the 10-day course. The patch will be placed at 9am and removed at 4pm daily for 10 days. During the 10 days, each subject will be monitored for continuous 240 hours by actigraphy based activity monitors to follow activity levels and energy expenditure.
16234891|NCT01124487|Dietary Supplement|The acute effects of dietary fat on lipid profile, insulin sensitivity and inflammatory markers|
16234892|NCT01124474|Other|goal directed therapy|Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV>12%.
16234893|NCT01124448|Biological|Lactobacillus salivarius PS2|9.5 log10 (colony-forming units), freeze-dried powder, daily for 21 days
16234894|NCT01124448|Biological|Lactobacillus salivarius PS2|9.5 log10 colony-forming units, oral route, freeze-dried powder, daily for 21 days
16234895|NCT01124435|Drug|Carboplatin plus Celecoxib|celecoxib (200 mg tablets by mouth twice daily, day 1 to 28), associated to intravenous carboplatin (area under the curve (AUC) 5 over 30 to 60 minutes, every 28 days).
16234896|NCT01124422|Drug|fluticasone propionate/salmeterol inhalation powder DISKUS 250/50|Experimental comparator consisting of inhaled corticosteroid plus long-acting beta agonist combination also known as ADVAIR DISKUS
16234897|NCT01124422|Drug|tiotropium bromide inhalation powder HandiHaler|Open-label drug also known as Spiriva HandiHaler
16234898|NCT01124409|Radiation|EPID Verification|Set up error verification and correction by EPID
16234899|NCT01124409|Radiation|CBCT verification|Setup error verification and correction by CBCT
16234900|NCT01124396|Drug|DSP-3025|
16234901|NCT01124396|Drug|Placebo|
16234902|NCT01124383|Procedure|General anesthesia|For women in the general anesthesia group, general anesthesia is induced using midazolam 1-3 mg, sufentanil 0.15-0.25 mcg/kg and propofol 1-3 mg/kg. Rocuronium 0.6 mg/kg is allowed. Anesthesia is maintained with sevoflurane titrated to maintain a blood pressure within 20% of preoperative normal and, if needed, ephedrine can be used for this purpose. Patients are ventilated in a normocapnic range with a positive end-expiratory pressure of 3 to 5 mmHg.
16234903|NCT01124383|Procedure|Local anesthesia with sedation|For women in the local anesthesia group a paracervical block is performed by the gynecologist using a total of 20 mL of 1% lidocaine intracervically at 2, 4, 7 and 10 o'clock positions and in the area of uterosacral ligaments. Once the block completed, the surgeon waits at least five minutes before performing cervical dilatation to allow for sufficient analgesia. Intravenous sedation consists of midazolam, sufentanil and propofol administered by the anesthesiologist in sufficient doses to maintain a spontaneous ventilation with a Ramsay score < 4.
16235084|NCT01122901|Other|laboratory biomarker analysis|Correlative studies
16235085|NCT01122888|Drug|Cilengitide|Given IV
16234904|NCT01124370|Device|remedē (TM) system|Implantation of the remedē (TM) system, including implantable pulse generator, stimulation lead, and (optional) sensing lead. Nightly provision of unilateral transvenous phrenic nerve therapy during sleep periods.
16234905|NCT01124357|Device|NovaSure|Bipolar radio-frequency energy ablation of the endometrium by thermal therapy under impedance control. The bipolar current generated by the device produces a tapered depth of ablation with shallower ablation in the cornual regions / lower uterine segment and a deeper ablation in the mid-body of the uterus..
16234906|NCT01124357|Device|thermachoice|ThermachoiceTM III thermal balloon ablation
16234907|NCT01124344|Drug|Placebo|Oral Solution, Oral, 0 mg, Once Daily, 14 days
16234908|NCT01124344|Drug|BMS-866949|Oral Solution, Oral, 3 mg, Once Daily, 14 days
16234909|NCT01124344|Drug|BMS-866949|Oral Solution, Oral, 10 mg, Once Daily, 14 days
16234910|NCT01124344|Drug|BMS-866949|Oral Solution, Oral, 30 mg, Once Daily, 14 days
16234911|NCT01124344|Drug|BMS-866949|Oral Solution, Oral, 45 mg, Once Daily, 14 days
16234912|NCT01124344|Drug|BMS-866949|Oral Solution, Oral, 60 mg, Once Daily, 14 days
16234913|NCT01124344|Drug|BMS-866949|Oral Solution, Oral, 90 mg, Once Daily, 14 days
16234914|NCT01124344|Drug|BMS-866949|Oral Solution, Oral, 3-60 mg, Once Daily, 14 days
16234915|NCT01124331|Procedure|Higher oxygen saturation target range (91%-95%)|higher (SpO2 91-95%) functional oxygen saturation target range from birth, or soon thereafter
16234916|NCT01124331|Procedure|Lower oxygen saturation (85%-89%)|Lower (SpO2 85%-89%)functional oxygen saturation target range from birth, or soon thereafter
16234917|NCT01124318|Drug|Lactofiltrum|Lactofiltrum (hydrolytic lignin 0.355, lactulose 0.12) 2 tablets three times a day before meals during 21 days
16234918|NCT01124318|Drug|Placebo|Placebo 2 tablets 3 times a day before meals during 21 days
16234919|NCT01124305|Device|Customized Patient Instrumentation|Custom cutting guides based on computed tomography (CT) images of the patient's leg are used to make the bone cuts and select the implant size.
16234920|NCT01124305|Device|Traditional Instrumentation|Traditional surgical instruments will be used to make bone cuts and size the components in this control group.
16234921|NCT01124292|Procedure|Tongue Piercing|Subjects brush their teeth, and then swish and spit with chlorhexidine mouthwash for 30-60s. Subjects would be placed in a semirecumbent position in a procedure chair. After marking the piercing site using a sterilized surgical marking pen the protruded tongue would be pierced. Anesthesia may be used during the piercing at the discretion of the operator and the subject. A sterilized titanium or surgical grade stainless steel piercing tongue stud would be placed in an appropriate position on the tongue to minimize complications from the piercing but also facilitate good functionality of the TDS.
16234922|NCT01124292|Device|Usability assessment|"Computer access: Subjects wear the TDS and get trained. Then they sit 1.5 m from a 22 LCD monitor. Then they use TDS to conduct several tasks using their tongues, such as clicking on target objects and navigating through on-screen maze, while the computer registers their tongue commands and measures their performance.
~Wheelchair control: Subjects wear the TDS and use it to drive an electrically powered wheelchair through an obstacle course using their tongues. The operator measured the time it takes for the subjects to drive through the course as well as the number of collisions."
16234923|NCT01124279|Drug|AMG 853|Single dose administration of AMG 853 in tablet form to healthy adult subjects
16234924|NCT01124266|Procedure|standard of care colonoscopy|Single inspection by endoscopist during colonoscopy
16234925|NCT01124266|Procedure|standard of care colonoscopy|Dual inspection by both endoscopist and nurse during colonoscopy
16234926|NCT01124253|Drug|recombinant human endostatin|recombinant human endostatin 15mg per ampul for injection 7.5mg/m2 IV (in the vein) on 1st to 14th days of a 21- day cycle, totally 4 cycles are needed
16234927|NCT01124240|Drug|Cilengitide|"Cilengitide 2000 mg flat i.v. twice weekly is administered over a period of 18 months without interruption.
~Starting one week after the initiation of Cilengitide, RTX (60 Gy, 2 Gy per fraction) with concurrent daily temozolomide (60 mg/m2 p.o.) and daily procarbazine (PCB, 50 mg p.o. if BSA < 1.7; 100 mg p.o. if BSA ≥ 1.7) is given over a period of 6 weeks (RTX Monday to Friday, both TMZ and PCB seven days a week).
~After a break of 4 weeks, adjuvant TMZ (50mg/m2 p.o in first cycle, 60 mg/m2 p.o. in subsequent cycles) and PCB (50 mg p.o. if BSA < 1.7; 100 mg p.o. if BSA ≥ 1.7) are then given daily D1 to 20. This TMZ/PCB cycle is repeated every 28 days over a total period of 6 cycles."
16234928|NCT01124227|Drug|icodextrin|2000 ml icodextrin intraperitoneally one or two times a day. Dose will be adapted clinically as in standard peritoneal dialysis.
16234929|NCT01124214|Procedure|endomicroscopy|endomicroscopy scope lens has capability to optically evaluate mucosa/submucosa as a microscope
16234930|NCT01124201|Other|Stabilization , strengthening and stretching|Interventions were conducted over 6 weeks, twice per week, lasting 30 minutes each. Sessions were supervised by the investigator, and participants were instructed to report any adverse event. Groups were instructed not to participate in any other physical program during the study. Forty-five patients were randomized into three groups namely: Segmental stabilization group (ES)(transversus abdominis and lumbar multifidus), superficial strengthening group (FS)(rectus abdominis, oblique abdominal muscles and erector spinae muscles) and stretching group (AL) (erector spinae, posterior connective tissues and ischiotibials muscles). Patients were evaluated for pain , functional disability,and ability to contract the TrA before and after the treatment.
16234931|NCT01124188|Drug|Higher-dose venlafaxine|Dosing of venlafaxine will range from 187.5-300 mg/day.
16234932|NCT01124188|Behavioral|Supportive management|Supportive management encourages participants to take the medication and manages any treatment-emergent side effects. Ten sessions will be delivered over the course of 14 weeks.
16234933|NCT01124188|Behavioral|Problem Solving Therapy for Depression and Pain|PST-DP will be delivered over the course of 10 sessions over 14 weeks. Along with teaching the participant 7 steps of problem solving, PST-DP also includes a medication support and management component.
16234934|NCT01124175|Drug|Losartan|100 mg Tablets
16234935|NCT01124175|Drug|Cozaar®|100 mg Tablets
16234936|NCT01124162|Drug|Losartan|100 mg Tablet
16234937|NCT01124162|Drug|Cozaar®|100 mg Tablet
16234938|NCT01124149|Drug|MMX mesalamine/ mesalazine|4.8g/day given QD (four 1.2g tablets) for 8 weeks, 2.4g/day given QD (two 1.2g tablets) for 12 months
16235086|NCT01122888|Other|Clinical Observation|Patients undergo a 2-week rest period
16234939|NCT01124136|Device|Neurostimulation + Medication Management (Standard of Care)|In addition to medication management, adding investigational implanted neurostimulator to heart
16234940|NCT01124136|Drug|Standard of Care (Control)|Standard of Care Therapy consists of medication management only to support heart for rhythm, anticoagulation, and rate, and comorbid symptoms, i.e. diuretics, lipid lowering.
16234941|NCT01124123|Drug|Bilastine|20 mg oral tablet
16234942|NCT01124123|Drug|Bilastine|10 mg endovenous bilastine
16234943|NCT01124110|Behavioral|Tobacco Tactics Web-Based Intervention|The Tobacco Tactics Web-Based Intervention contains website, medications, and nurse counseling.
16234944|NCT01124110|Other|1-800-QUIT-NOW Telephone Hotline|The control group receives efficacious smoking cessation treatment via the 1-800-QUIT-NOW telephone hotline. The 1-800-QUIT-NOW hotline is a national program. The first time smokers call the hotline, they receive a personal coach who assists them in setting a quit date and making an individualized quit plan. The personal coach also provides on-going support with up to five telephone coaching sessions around the caller's quit date.
16234945|NCT01124097|Drug|Eslicarbazepine acetate (BIA 2-093)|Tablets will be used.
16234946|NCT01124097|Drug|Placebo|Tablets will be used.
16234947|NCT01124071|Behavioral|Provision of 2 Korean meals per day 6 days per week|At each participant's baseline visit, participant's will have an individualised lifestyle session addressing dietary and exercise goals and techniques to achieve weight loss. Participants in the Korean diet group will pick up lunch and evening meals Monday-Friday. Raw ingredients and cooking instructions will also be provided on friday for saturday meal preparation. Ongoing lifestyle sessions will be performed weekly for participants.
16234948|NCT01124071|Behavioral|Western Diet|At each participant's baseline visit, participant's will have an individualised lifestyle session addressing dietary and exercise goals and techniques to achieve weight loss. Participants in the Western diet group will be provided with a Western recipe cookbook and food vouchers (weekly) to purchase the necessary ingredients for the Western meal preparation. Ongoing lifestyle sessions will be performed weekly for participants.
16234949|NCT01124058|Drug|warfarin|"Patients will be randomized to re-start warfarin at their maintenance dose or at a loading dose (1.5 times the maintenance dose for 3 days, then resumption of warfarin dosing as per the maintenance dose)."
16234950|NCT01124058|Drug|Warfarin|"Maintenance dose is the amount of warfarin that a patient required to maintain a therapeutic INR."
16234951|NCT01124045|Drug|Difluprednate ophthalmic emulsion, 0.05%|Topical ocular administration
16234952|NCT01124045|Drug|Prednisolone acetate ophthalmic suspension, 1.0%|Topical ocular administration
16234953|NCT01124032|Drug|methylphenidate|a capsule containing 20 mg
16234954|NCT01124006|Drug|Intradiscal rhGDF-5|The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. In vitro experiments have shown that rhGDF-5 can stimulate gene expression and synthesis of the extracellular matrix proteins type II collagen and aggrecan. In vivo experiments in rabbit models of disc degeneration have shown that intradiscal injections of rhGDF-5 can stimulate an increase in disc height and hydration.
16234955|NCT01124006|Other|Water for injection|Sterile water for injection
16234956|NCT01123993|Device|Music CD|During 4-week interventional period of each group, a researcher gives a CD to care giver and advises him/her to open the music for patient for at least 60 minutes daily, after dinner to bedtime. Meanwhile, the care giver notes the exact duration that patient actually listens to it in the calendar provided and returns the CD and document to the researcher at the end of interventional period.
16234957|NCT01123980|Drug|biphasic insulin aspart 30|Treat-to-target titration according to titration algorithm. Subcutaneous (under the skin) injection once daily.
16234958|NCT01123980|Drug|metformin|"China: Tablets, 500 mg. Min. 1500 mg/day.
~Japan: Tablets, 250 mg. Min 500 mg/day."
16234959|NCT01123980|Drug|glimepiride|"China: Tablets, 2 mg. Min. 4 mg/day.
~Japan: Tablets, 1 mg. Min. 4 mg/day."
16234960|NCT01123980|Drug|insulin glargine|Treat-to-target titration according to titration algorithm. Subcutaneous (under the skin) injection once daily.
16234961|NCT01123967|Other|proactive outreach (PRO)|a mailed invitation letter followed by telephone outreach
16234962|NCT01123967|Other|telephone counseling (TC)|free telephone counseling
16234963|NCT01123967|Other|Nicotine replacement therapy (NRT)|free nicotine replacement therapy (NRT)
16234964|NCT01123967|Other|Usual care (UC)|nicotine replacement products (patch, gum, lozenge, inhaler, and nasal spray)
16234965|NCT01123954|Biological|Seasonal flu vaccine|This phase II is performed as a monocenter study site in a population of healthy subjects aged 1 to 45 years. Enrolled subjects received one single IM dose of trivalent subunit inactivated influenza vaccine during the vaccination visit, according to the study protocol (follow-up period: 30 days)
16234966|NCT01123941|Biological|Typherix|1 dose, 0.5 mL containing 25 mcg of Vi polysaccharide
16234967|NCT01123941|Biological|NVGH Vi-CRM197|1 dose of 0.5 mL containing 25 mcg of Vi-CRM
16234968|NCT01123928|Behavioral|Video and counseling for cataract patients|Intervention includes: (1) a 5-10 min video consisting of testimony from a previous cataract patient and a doctor; (2) a 10-15 min pre-operative counseling session with a trained nurse, and (3) a 5 min post-operative counseling session with a trained nurse.
16234969|NCT01123915|Biological|Opal-HIV-Gag(c) Low Dose|
16234970|NCT01123915|Biological|Opal-HIV-Gag(c) Medium dose|
16234971|NCT01123915|Biological|Opal-HIV-Gag(c) High dose|
16234972|NCT01123915|Other|Dimethyl Sulfoxide|
16234973|NCT01123902|Device|hand-held fan|Patients are instructed to direct the hand-held fan towards the face around the central part of the face, the sides of the nose and above the upper lip. The hand-held fan has three soft rotor blades and an unfoldable rotor unit.
16234974|NCT01123902|Device|wristband|Patients are instructed to wear the wristband continually and pull it regularly at short intervals when breathless or during breathlessness attacks.
16235040|NCT01123226|Procedure|spinal manipulation|A maximum of two high velocity low amplitude spinal manipulations to one dysfunctional spine joint
16235087|NCT01122888|Other|Laboratory Biomarker Analysis|Correlative studies
16235088|NCT01122875|Drug|MFGR1877S|Intravenous repeating dose
16234975|NCT01123889|Biological|platelet rich plasma injection|45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions.
16234976|NCT01123889|Drug|corticosteroid injection|Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions.
16234977|NCT01123876|Drug|Veliparib|Subjects will be given Veliparib twice daily on Days 1-5 and 15-19 every 28 days orally
16234978|NCT01123863|Other|Brigance Preschool Screen -II|Three-year-old children with SCD who are followed at the St. Jude Children's Research Hospital Sickle Cell Center will be offered developmental screening with the Brigance Preschool Screen II during their regular clinic visits. Along with the screening test, socioeconomic data will be collected using a short questionnaire. Families will be asked to participate in this study by allowing us to collect their test results, medical information and socioeconomic data to compare with data collected from the control group. Parents who decline participation in this study will still be offered the Brigance Preschool Screen II as part of their child's clinical care.
16234979|NCT01123863|Other|Brigance Preschool Screen -II|"Children in the Control Group will be given the Brigance preschool Screen-II Screening at the daycare they attend. The STARR coordinators have selected four daycare centers that have agreed to serve as control group sites. The family will be asked not to respond or aid the child during the assessment. One parent/guardian will fill out the Socioeconomic Data Collection Form while the examiner works with the child.
~The screening requires the child to give both verbal and non-verbal responses. The examiner records responses on the Three-Year-Old Child Data Sheet for the Brigance Preschool Screen-II. After the screening is complete the examiner collects the Socioeconomic Data Collection Form from the parent and leaves the room to score the assessment and write recommendations. The examiner then returns to the clinic room to discuss the results with the parent/guardian."
16234980|NCT01123850|Device|Copios|Bone Void Filler
16234981|NCT01123837|Other|Intravenous fluid|"The treatment group will receive a 250cc bolus over 2 hrs of D5LR prior to the end of surgery and continued in the PACU. Blood glucose will be checked 3 different times using an Accu-chek monitor along with the type and number of rescue medications given at 30, 60, and 120 minutes after anesthesia and the post-op morning.
~The control group will receive a 250cc bolus over 2 hours of LR. Blood glucose will be monitored 3 times along with the type and how much of rescue medications are given at 30, 60 and 120 minutes post-op and the morning after surgery."
16234982|NCT01123837|Other|D5LR or lactated ringers|"The purpose of the study is to see if giving dextrose fluid in the veins (IV) decreases the risk of postoperative nausea and vomiting (PONV) in female urologic, gynecologic and breast outpatient surgery patients and at what blood sugar level.
~The reason for this study is that IV dextrose may decrease the incidence of PONV and the use of medications to treat PONV, while leading to sooner discharge after surgery. This can decrease overall healthcare cost and improving patient satisfaction."
16234983|NCT01123824|Drug|CLOPIDOGREL|"Pharmaceutical form: tablets
~Route of administration: oral"
16234984|NCT01123824|Drug|placebo|"Pharmaceutical form: matching tablets
~Route of administration: oral"
16234985|NCT01123811|Drug|Cetuximab IF|Cetuximab loading dose 400 mg/m² weekly dose 250 mg/m² Irinotecan 80 mg/m2 i.v. over 2 hours day 1, 8, 15, 22, 29, 36 Folinic acid 200 mg/m2 over 24 hours day 1, 8, 15, 22, 29, 36 FA will be given as sodium folinate 5-FU 1500 mg/m2 continuous infusion over 24 hours day 1, 8, 15, 22, 29, 36
16234986|NCT01123798|Device|near-infrared spectroscopy|Non-invasive monitoring device applied on the surface of the skin that emits harmless red light to measure tissue perfusion.
16234987|NCT01123785|Drug|INO-8875|eye drops for 14 days in one eye
16234988|NCT01123785|Drug|Placebo|Matched vehicle-control
16234989|NCT01123772|Drug|INO-8875|eye drops for 14 days in one eye
16234990|NCT01123772|Other|Placebo control|Matched placebo
16234991|NCT01123759|Other|Feeding low mercury fish|Subjects fed 6 oz of either tilapia (low omega-3 fish) or salmon (high omega-3 fish) for 3 months. Both fish are low in mercury
16234992|NCT01123707|Drug|Aripiprazole/Escitalopram combination therapy|Aripiprazole/Escitalopram combination therapy: 3 mg/10 mg, 3 mg/20 mg, 6 mg/10 mg, 6 mg/20 mg, 12 mg/10 mg or 12 mg/20 mg
16234993|NCT01123694|Other|Survey Study|Survey regarding quality of life
16234994|NCT01123681|Device|Choice of endotracheal tube|Types of endotracheal tube, normal cuff without sub-glottic aspiration, normal cuff with sub-glottic aspiration, Special cuff with sub-glottic aspiration
16234995|NCT01123655|Drug|APLA12|Intervention: Drug treatment will be stopped or interrupted if indicated. Medical care will be provided at no cost to the patient.
16234996|NCT01123655|Drug|Placebo|Drug treatment will be stopped or interrupted if indicated. Medical care will be provided at no cost to the patient.
16234997|NCT01123616|Procedure|abdominal wall closure|triclosan-coated (PDS-Plus) and non-coated (PDS) suture to close the abd. wall
16234998|NCT01123577|Other|Home Blood Pressure Monitor Group|Participants receive home monitors, modems, educational materials and training. Participants will send home BP readings to research database monthly and receive usual care by providers for 9 months.
16234999|NCT01123564|Drug|ranibizumab|applied monthly in the first 3 months period, and after this only if visual acuity (VA) decreases with more than 5 letters at any monthly visits
16235000|NCT01123564|Radiation|Argon laser treatment|Conventional grid pattern argon laser treatment and panretinal argon laser photocoagulation in an as needed basis.
16235001|NCT01123551|Drug|nebulized morphine|After randomization, patients will receive 10 mg of morphine (1ml) diluted in 4 ml normal saline and nebulized with 6 l/mn during 10 min. Nebulization will be repeated systematically 3 times every twenty minutes unless the patient pain was resolved (VAPS 30%). In addition, patients receive a bolus of IV placebo(5 ml normal saline . IV placebo (2 ml) will be repeated every 10 minutes if the objective of analgesia was not reached .
16235081|NCT01122901|Drug|gamma-secretase/Notch signalling pathway inhibitor RO4929097|Given PO
16235082|NCT01122901|Procedure|therapeutic conventional surgery|Undergo surgery
16235002|NCT01123551|Drug|Intravenous morphine|After randomization, patients will receive a bolus of 5 mg of IV morphine (5 ml. Then, 2mg of IV morphine (2ml) will be added every 10 minutes if the objective of analgesia was not reached (VAPS >30%). In addition, normal saline (5ml)is nebulized with 6 l/mn during 10 min and will be repeated systematically every 20 minutes unless the patient's pain was not resolved (VAPS >30%).
16235003|NCT01123538|Drug|Progesterone|200 mg/day oral micronized natural progesterone (e.g. Utrogestan® 100mg) + 0.05 mg/day transdermal (i.e. plaster) 17β-estradiol (e.g. Estraderm® 50µg) during a year
16235004|NCT01123538|Drug|Chlormadinone acetate|5 mg/day oral chlormadinone acetate (e.g. Luteran® 5mg)+ 0.05 mg/day transdermal (i.e. plaster) 17β-estradiol (e.g. Estraderm® 50µg)
16235005|NCT01123525|Drug|Adenosine|1.2 mM adenosine instead of supranormal potassium in the cardioplegic solution
16235006|NCT01123512|Device|Vertebral augmentation|Vertebral augmentation for one or two osteoporotic vertebral compression fractures
16235007|NCT01123486|Drug|hydromorphone|hydromorphone 0.02 mg/kg
16235008|NCT01123473|Drug|capecitabine|
16235009|NCT01123473|Drug|cisplatin|
16235010|NCT01123473|Drug|epirubicin hydrochloride|
16235011|NCT01123473|Drug|fluorouracil|
16235012|NCT01123473|Drug|lapatinib ditosylate|
16235013|NCT01123460|Other|enzyme-linked immunosorbent assay|
16235014|NCT01123460|Other|laboratory biomarker analysis|
16235015|NCT01123447|Procedure|Open reduction and internal fixation|Patients will undergo surgery for open reduction of the fracture and internal fixation with an LC-DC plate and screw fixation.
16235016|NCT01123447|Procedure|Closed reduction and short-arm cast|Patient will undergo a closed reduction and be placed in a short-arm (below-elbow) cast for 6 weeks.
16235017|NCT01123408|Drug|Clozapine|500 mg/day
16235018|NCT01123408|Drug|Olanzapine|20 mg/day
16235019|NCT01123408|Drug|Haloperidol|20 mg/day
16235020|NCT01123395|Drug|colchicine 0.6 mg tablet|One Colcrys® 0.6 mg intact tablet taken by mouth
16235021|NCT01123395|Drug|colchicine 0.6 mg tablet|One Colcrys® 0.6 mg tablet dissolved in apple juice
16235022|NCT01123382|Device|Intramuscular Electrical Stimulator|A sterile percutaneous IM electrode is implanted in the shoulder using a 20-gauge hypodermic needle and connected to an external cable. The exit site and electrode are covered by a bandage, but the cable extends out. After a one week stabilization period, the cable is connected to a stimulator. A self-adhesive surface electrode serves as the indifferent electrode. Stimulation intensity is set by the investigator. The prescription for daily stimulation treatment will be 6 hrs. The duty cycle and daily dose will remain constant throughout the treatment, but stimulus parameters may be adjusted by the research staff as deemed appropriate. The treatment period will be 3 weeks, after which the electrode will be removed. Total time of electrode implantation is no more than 29 days.
16235023|NCT01123382|Other|Outpatient Therapy|Subjects will receive 8 hrs of outpatient therapy over a four week period from a treating therapist, coupled with prescribed daily home exercises. The therapist will implement an individualized treatment plan consistent with the needs of the participant.
16235024|NCT01123356|Drug|Ofatumumab|"Ofatumumab 2000 mg (300 mg on first cycle) IV on day 1 for up to 6 cycles (28 day cycles)
~Treatment to be administered for up to 6 cycles"
16235025|NCT01123356|Drug|Lenalidomide|-Lenalidomide 10 mg (5 mg on first cycle) PO days 8-28 for up to 6 cycles (28 day cycles)
16235026|NCT01123343|Device|TrueVision 3D Visualization and Guidance System for MicroSurgery|Adjunct imaging tool (to the microscope oculars) that provides onscreen video guidance for alignment, orientation, and sizing during eye surgery, based on a surgeon's defined nomogram
16235027|NCT01123330|Behavioral|Motivational Interviewing|
16235028|NCT01123317|Drug|Oxytocin|Subjects will be randomly assigned to either OT-Placebo or Placebo-OT order for PET scan drug administration and will receive the first of the two intranasal doses at Pet scan 1 and the second intranasal dose of the subsequent treatment at Pet Scan 2
16235029|NCT01123304|Drug|MORAb028|1 mg MORAb-028 will be injected at either 1 mg/cm3 per day over 5 days for a total dose of 5 mg for the first cohort and 2 mg/cm3 for the second cohort. Subjects will receive MORAb-028 injections on Days: 1-5, 8-12 and 22-26.
16235030|NCT01123291|Procedure|follow-up coronary angiography|follow-up coronary angiography at 8-12 months after discharge for percutaneous coronary intervention
16235031|NCT01123291|Procedure|Clinical follow-up|no routine follow-up coronary angiography at 8-12 months after discharge for percutaneous coronary intervention
16235032|NCT01123278|Drug|Testosterone|Testosterone transdermal gel 50 mg/day (5 gr)
16235033|NCT01123278|Drug|Placebo|Placebo transdermal gel (5 gr)
16235034|NCT01123265|Drug|Methotrexate|Subjects will start Methotrexate which will be escalated from 7.5 mg weekly to 15 mg/weekly over a 3 week period.
16235035|NCT01123265|Drug|Anti-TNF|Anti-TNF to be administered per standard of care within the practice.
16235036|NCT01123252|Dietary Supplement|Lactobacillus casei Shirota (LcS)|Subjects will receive one bottle of Yakult containing the probiotic bacterium Lactobacillus casei Shirota (active drink) once daily for 4 months (16 weeks).
16235037|NCT01123252|Dietary Supplement|Placebo|Subjects will receive one bottle of a placebo milk drink, once daily for 4 months (16 weeks).
16235038|NCT01123239|Behavioral|Coached Care|"Coached Care pairs patients with linguistically and ethnically matched peer coaches, who themselves have diabetes, and have been trained to meet with patients immediately before each of their regularly scheduled medical visits to encourage active involvement in information seeking and decision-making. Using a decision tree algorithm, they help patients identify relevant questions about symptoms, barriers to self-management and treatment options to discuss with doctor. They encourage mutual decision-making about tailoring the patient's medication regimen, diet and physical activities and work with the patients to overcome barriers to communication with their doctor. After the medical visit, the coach and patient review any treatment decisions and goals for self-care."
16235039|NCT01123239|Behavioral|Standard Diabetes Education|Patients randomized to the control group will receive 20 minutes of standardized diabetes education delivered by staff research assistants. Education materials have been adapted from materials developed by the American Diabetes Association. The content of these materials includes information about the causes and complications of diabetes, as well as ways to reduce complication risks. Patients in the control arm will receive 20 minutes of standardized diabetes education before each visit
16235083|NCT01122901|Other|pharmacological study|Correlative studies
16235041|NCT01123226|Procedure|trigger point therapy|The thumb will apply firm pressure to a trigger point in the paravertebral multifidus and rotatores muscles associated with the spine joint dysfunction using the barrier approach. This will be held until the barrier releases and this will continue until the trigger point is inactivated or 3 minutes has passed.
16235042|NCT01123200|Device|Brain Computer Interface for Wheelchair Tilt Control|Patients will be given the BCI for use in-home, as long as they use the BCI at least 10 hours per week and complete monthly performance assessment sessions.
16235043|NCT01123187|Procedure|islet transplantation|Islet transplantation consisted of up to three sequential fresh islet infusions within three months. Access to the portal vein was gained under general anesthesia by percutaneous catheterisation of a peripheral portal branch under ultrasound guidance or by surgical catheterisation of a small mesenteric vein.
16235044|NCT01123174|Behavioral|ALGOS algorithm of case management|"If the subject survives one 1st SA (first attempter): he leaves the center where he was included with a chart resource (crisis card) which contains addresses of the Web sites of associations of prevention of the suicide, as well as an accessible phone number 24/24h.
~If the subject is not a first attempter : he will be recontacted on the telephone between the 10th and the 21st day following the SA. If the subject is not contacted or little observing in the plan of care, it will receive a series of postcards then regularly, with 4 recoveries: to 2, 3, 4 and 5 months after the attempt."
16235045|NCT01123161|Device|hypothermia and anti-shivering treatment|Hypothermia is induced using the Celsius Control™ System. Shivering is treated with buspirone, meperidine and surface warming
16235046|NCT01123161|Drug|Group1: IV t-PA and normothermia|Group 1 will t-PA as standard of care and normothermia
16235047|NCT01123148|Device|Using a BCI to control wheelchair tilt|Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) during each session and use a P300 based BCI to type words and control wheelchair tilt. Subjects will be asked to participate in 3 sessions.
16235048|NCT01123135|Drug|Vaginal ERT|1gm of estrogen vaginal cream [EVC] at bed time 3 times a week
16235049|NCT01123135|Drug|Placebo|Placebo
16235050|NCT01123122|Other|Strict glucose control|Blood glucose level to be maintained at 4-6 mmol/L at the time of islet transplantation until two weeks post-transplantation.
16235051|NCT01123109|Procedure|3-D Endoanal Ultrasound|The subject will be placed in the supine position with their feet in the stirrups and a drape will be used, exposing only the anus and perineum in order to introduce the probe. In order to prevent and minimize any potential discomfort, the lubricated ultrasound probe will be gently inserted into the anal canal up to the anal verge, with minimal manipulation of the probe once inserted. The scan lasts approximately two minutes and the entire exam will take no more than five minutes.
16235052|NCT01123096|Procedure|Cough Stress Test|A cough stress test is performed by using a catheter to introduce 300ml of sterile water into the bladder. The patient is then asked to stand and cough forcefully and the clinician will observe for urine loss.
16235053|NCT01123096|Other|24 Hour Pad Test|The patient will be provided with a standard number of pads in a sealed bag that have been pre-weighed. The patient will wear the pads for 24 consecutive hours then return the all the pads within the bag for weighing post usage.
16235054|NCT01123083|Biological|Otelixizumab|infusion
16235055|NCT01123083|Biological|Placebo|Infusion
16235056|NCT01123070|Biological|TL011, anti CD20, for the treatment of rheumatoid arthritis|TL011 administered by 2 infusions, 2 weeks apart
16235057|NCT01123070|Biological|MabThera infusions|MabThera, administered by 2 infusions, 2 weeks apart
16235058|NCT01123057|Procedure|riboflavin-induced collagen cross-linking treatment|"The principle of the procedure is to induce collagen crosslinking of the corneal stroma by the using riboflavin/UVA-treatment.
~The technique involves topical application of riboflavin/dextran solution onto eye after removal of corneal epithelium. After initial riboflavin application for 30 minutes, UVA light is shone onto the cornea for another 30 minutes with continued topical riboflavin application."
16235059|NCT01123057|Device|Riboflavin-UVA induced collagen cross-linking treatment for corneal ectasia|Use of riboflavin eyedrops during the procedure Use of UVA device (Peschke Meditrade)
16235060|NCT01123044|Biological|conservative|Undergo autologous transplantation of limbal epithelial cells cultured on amniotic membrane
16235061|NCT01123044|Procedure|Medical Therapy|Under usual care treatment
16235062|NCT01123031|Drug|lansoprazole|lansoprazole 30 mg four times daily for three days followed by 30 mg once daily for two months
16235063|NCT01123031|Drug|esomeprazole|esomeprazole 160 mg/day continuous infusion for three days followed by 40 mg once daily orally for two months
16235064|NCT01123018|Behavioral|Memtrax Memory screening test|Memory Screening test
16235065|NCT01123005|Procedure|PET Scan|radiation calculated per patient
16235066|NCT01123005|Drug|EF5|10 mCi, IV
16235067|NCT01123005|Drug|Carbogen|Calculated per patient
16235068|NCT01123005|Drug|Dichloroacetate|
16235069|NCT01122992|Procedure|Limbal relaxing incision|
16235070|NCT01122979|Drug|INSULIN GLARGINE|Pharmaceutical form: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 mL) Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia
16235071|NCT01122979|Drug|NPH insulin (insulin isophane)|Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia
16235072|NCT01122979|Drug|INSULIN GLULISINE|Pharmaceutical form: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 mL) Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia
16235073|NCT01122979|Drug|Regular insulin|Pharmaceutical form: solution for injection Route of administration: subcutaneous Dose regimen: dose adjusted to the patient's glycemia
16235074|NCT01122966|Drug|intraocular injections of bevacizumab|intracameral and subconjunctival injections
16235075|NCT01122953|Drug|Phenytoin|Single dose of Phenytoin 125 mg/5 ml suspension made by Laboratorios Pfizer, S.A. de C.V.
16235076|NCT01122953|Drug|Epamin|Single dose Epamin 125 mg/5 ml suspension made by McNeil LA LLC
16235077|NCT01122940|Drug|Epamin: Reference Drug|Single dose of 75 mg (10 ml in suspension) of Epamin
16235078|NCT01122940|Drug|Phenytoin: Study Drug|Single dose of 75 mg (10 ml in suspension) of Phenytoin
16235079|NCT01122927|Drug|Aripiprazole|Aripiprazole (2-mg, 5-mg, 10-mg, 15-mg, 20-mg, 25-mg or 30-mg) pill taken orally once per day
16235080|NCT01122914|Drug|Anakinra|
16235089|NCT01122862|Drug|0.12% chlorhexidine mouthrinse|commercially available 0.12% chlorhexidine mouthrinse
16235090|NCT01122862|Other|Cosmetic mouthrinse|Commerically available cosmetic mouthrinse
16235091|NCT01122862|Other|Sterile water|Sterile water
16235092|NCT01122849|Device|Prototype Nasal Dilator|Prototype nasal dilator AB2R11
16235093|NCT01122849|Device|Marketed Nasal Strip|Breathe Right Nasal Strip- Clear small/medium
16235094|NCT01122849|Device|Placebo Nasal Strip|Placebo strip
16235095|NCT01122836|Other|Massage|Therapeutic Massage
16235096|NCT01122823|Behavioral|chronic disease self-management program (online)|The online CDSMP is an internet-based program for people with 1 or more chronic conditions. It's built on self-efficacy theory, facilitated by lay leaders, and uses a curriculum emphasizing problem solving, decision making, and confidence building in weekly sessions over six weeks. It addresses generic topics and skills relevant to managing any chronic condition, including: action plans; problem solving; nutrition; exercise; fatigue; breathing; managing medications; managing stress and emotions; working with health care providers. The structure includes: 1) password-protected, interactive web-based instruction; 2) web-based bulletin board discussion groups to enable participatory learning and support; 3) and a reference book that contains the program content and supplemental information.
16235097|NCT01122810|Procedure|Coronary scanner|The ECG-gated contrast-enhanced multidetector computed tomography coronary angiography will be performed with a 64 or 256-row CT Philips, Brilliance. The contrast medium mean quantity used is 80-100 ml. The CT scan parameters, adapted to the patient's weight, include 120 kV, 800mA, 0.625 mm slice thickness, 0.42-s rotation time and 0.2 pitch. To determine X-Ray exposure, Dose Length Product (Gycm) will be measured. Reconstruction will be performed at 40 and 75 % of the cycle using ECG gating. A semi quantitative analyse of coronary narrowing will be performed blindly to coronary angiogram results by two experienced radiologists. The CT quality will be determined using a quality scale from 1 to 5. A Calcification score will also be determined. A segment analyse will be performed according to AHA classification. Only more than 1.5 mm diameter vessel segments will be analysed.
16235098|NCT01122784|Biological|rF1V vaccine (with Adjuvant)|80 mcg rF1V vaccine with adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 182
16235099|NCT01122784|Biological|rF1V vaccine (without Adjuvant)|80 mcg rF1V vaccine without adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 182
16235100|NCT01122784|Biological|rF1V vaccine (with Adjuvant)|80 mcg rF1V vaccine with adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 121
16235101|NCT01122784|Biological|rF1V vaccine (without Adjuvant)|80 mcg rF1V vaccine without adjuvant given by intramuscular (IM) injection into the arm on Study Days 0, 56 and 121
16235102|NCT01122771|Drug|Liposomal amphotericin B|Ambisome i.v. 5mg on days 1, 3 and 5
16235103|NCT01122771|Drug|liposomal amphotericin B + miltefosine|Ambisome 5mg single dose iv Oral Miltefosine 1.5-2.5 mg/kg in 1 or 2 doses a day, for 10 days (days 1-10)
16235104|NCT01122771|Drug|liposomal amphotericin B + paromomycin|Oral Miltefosine 1.5-2.5 mg/kg in 1 or 2 doses a day, for 10 days (days 1-10) + Paromomycin base 11mg/kg/day IM for 10 days (days 1-10).
16235105|NCT01122771|Drug|Miltefosine + Paromomycin|Oral Miltefosine 1.5-2.5 mg/kg in 1 or 2 doses a day, for 10 days (days 1-10) + Paromomycin base 11mg/kg/day IM for 10 days (days 1-10).
16235106|NCT01122719|Device|Drug Eluting Stent|
16235107|NCT01122706|Other|Taiji training|Taiji training during 12 weeks (twice a week for 1 hour) (Sept. 6th till Nov. 25th 2010). The first 18 sequences of a series of 37 movements of the short form Yang style Taiji will be taught. The focus will be on memorizing the series of movements, developing a regular training routine and working on body alignment and flow of the movements.
16235108|NCT01122693|Device|eZono - high-quality 2D ultrasound images|higher ultrasound frequencies, better image resolution, better post-processing and user-friendliness.
16235109|NCT01122693|Device|standard 2D ultrasound images|current standard in two-dimensional (2D) ultrasound images
16235110|NCT01122680|Drug|Tiotropium bromide|inhalation solution, dose of 1.25 mcg (2 puffs of 0.625 mcg)
16235111|NCT01122680|Drug|tiotropium bromide|inhalation solution, dose of 2.5 mcg (2 puffs of 1.25 mcg)
16235112|NCT01122680|Drug|tiotropium bromide|inhalation solution, dose of 5 mcg (2 puffs of 2.5 mcg)
16235113|NCT01122680|Drug|Placebo|placebo inhalation solution
16235114|NCT01122667|Drug|anacetrapib|single dose administration of anacetrapib (MK0859) 100 mg oral tablet
16235115|NCT01122641|Drug|Vildagliptin|Vildagliptin 50mg bid
16235116|NCT01122641|Drug|Placebo|Matched tablets
16235117|NCT01122628|Device|ORIF with DVR-A locking plate|Size, length of plate and number os screws decided by operating surgeon
16235118|NCT01122615|Drug|Sunitinib|12.5 to 50 mg orally (PO) daily x 14 days, 7 days off for 21 day cycle.
16235119|NCT01122615|Drug|Temsirolimus|6 to 25 mg intravenously (IV) over 30 minutes once weekly for 21 day cycle.
16235120|NCT01122602|Drug|Acetylsalicyclic acid (Fast acting Aspirin, BAY1019036)|Single dose of fast acting aspirin 2 x 325 mg = 650 mg total
16235121|NCT01122602|Drug|Acetylsalicyclic acid (Aspirin, BAYE4465)|Single dose of regular aspirin 2 x 325 mg = 650 mg total
16235122|NCT01122602|Drug|Placebo|Two placebo tablets
16235123|NCT01122589|Behavioral|Motivational Interviewing/CBT|6 sessions of in jail MI/CBT counseling will be administered.
16235124|NCT01122589|Other|CONcise Tapes Reviewing Obstacles to healthy Living (CONTROL)|a series of six weekly 30-45 minutes general wellness videos
16235125|NCT01122576|Device|Crystalens AO|Crystalens AO surgically implanted bilaterally. Study observation up to 180 days.
16235126|NCT01122576|Device|ReSTOR|ReSTOR surgically implanted bilaterally. Study observation up to 180 days.
16235127|NCT01122576|Device|Tecnis Multifocal IOL|Tecnis surgically implanted bilaterally. Study observation up to 180 days.
16235128|NCT01122563|Drug|Solifenacin|oral
16235129|NCT01122511|Drug|700 ug dexamethasone|Intravitreal injection of 700 ug dexamethasone into study eye
16235130|NCT01122511|Biological|ranibizumab|Intravitreal injection of ranibizumab into study eye
16235131|NCT01122511|Other|sham|Sham needle-less injection administered in the study eye
16235132|NCT01122498|Biological|BMP-655/ACS+Standard of care or Standard of care|BMP-655/ACS 0.015mg/mL
16235133|NCT01122498|Biological|BMP-655/ACS+Standard of care or Standard of care|BMP-655/ACS 0.05mg/mL
16235134|NCT01122498|Biological|BMP-655/ACS+Standard of care or Standard of care|BMP-655/ACS 0.15mg/mL or 0.025mg/mL
16235135|NCT01122485|Other|PG201|two tablets
16235136|NCT01122485|Other|Placebo|two tablets
16235137|NCT01122472|Drug|Lenalidomide|Daily for 3 weeks every 4 weeks for 24 months
16235138|NCT01122472|Drug|Placebo|Daily for 3 weeks every 4 weeks for 24 months
16235139|NCT01122459|Other|fluid administration|1.5mls/kg/hr fasting
16235140|NCT01122446|Other|Placebo comparator|"Placebo comparator day 1 and 30 in non-diabetic children with multiple islet autoantibodies.
~Post diagnosis: Two doses of 20 microgram Diamyd day 1 and 30 in children originally receiving placebo."
16235141|NCT01122446|Drug|Diamyd|"20 microgram day 1 and 30 in non-diabetic children with multiple islet autoantibodies.
~Post diagnosis: Two doses of Diamyd followed to children originally receiving Diamyd"
16235142|NCT01122433|Device|Endotracheal intubation using the C-MAC video laryngoscope|Using the C-MAC video laryngoscope for endotracheal intubation after failed direct laryngoscopy
16235143|NCT01122420|Other|Goal-Setting Tool|Access to an online health-related goal-setting tool through the MyHealthAtVanderbilt patient portal
16235144|NCT01122420|Other|Health Web Sites|Access to publicly available health-related web sites
16235145|NCT01122407|Drug|L-NMMA|L-NMMA 250 ug/Kg/min
16235146|NCT01122407|Drug|Trimethaphan|Will infuse trimethaphan for until complete autonomic blockade is achieved.
16235147|NCT01122394|Behavioral|TI|Tailored intervention based on the transtheoretical model
16235148|NCT01122394|Behavioral|AP|Attention placebo
16235149|NCT01122381|Drug|ethosuximide|ethosuximide (ESX)
16235150|NCT01122381|Other|placebo comparator|placebo
16235151|NCT01122368|Drug|micafungin|IV
16235152|NCT01122368|Drug|placebo|IV
16235153|NCT01122355|Drug|lipid modification|1) fenofibrate 160 mg po for 16 weeks, 2) niacin 500 mg po for 4 weeks, niacin 1000 mg po for 4 weeks, niacin 1500 mg po for 8 weeks
16235154|NCT01122342|Drug|Testosterone propionate|Testosterone USP micronized powder at a dose of 1mg/gr will be made into a paste with polysorbate 80 NF liquid and will be placed in an emollient cream base. A calibrated applicator will be supplied to measure out doses containing 300mcg of testosterone for daily application. The cream will be applied daily for 28 days. As above if safety and efficacy endpoints are met at this dose a lower dose (150mcg) will be used and if in tun this meets safety and efficacy endpoints a lower dose (75mcg) will be used.
16235155|NCT01122329|Dietary Supplement|caprylidene|Axona® is dosed as a 40g packet mixed into 8 oz of liquid (Ensure) for 45 days
16235156|NCT01122329|Dietary Supplement|Placebo|
16235157|NCT01122316|Drug|Metformin|3. Metformin will be started at 500 mg PO BID and pending lab values may be titrated to 1000 mg PO BID at 1 month.
16235158|NCT01122264|Drug|Tadalafil|Administered orally for 24 weeks.
16235159|NCT01122264|Drug|Sildenafil Citrate|Administered orally for 24 weeks.
16235160|NCT01122251|Drug|Lercanidipine + Valsartan|L10/V80, L20/V80, L10/V160, L20/V160
16235161|NCT01122251|Drug|Lercanidipine or Valsartan|L10, L20, V80, V160
16235162|NCT01122251|Drug|Placebo|Placebo of Lercanidipine and Valsartan
16235163|NCT01122238|Drug|Nicotine Patch|"If randomized to only the Nicotine Patch condition (and not the Nicotine Gum):
~Participants randomized to this condition will receive a 6-week supply of 14 mg patches at the initial visit. Participant will be instructed to use one patch daily for 6 weeks."
16235164|NCT01122238|Drug|Nicotine Gum|"If randomized to only the Nicotine Gum condition (and not the Nicotine Patch):
~Participants randomized to this condition will receive a 6-week supply of 2 mg gum at the initial visit. Participants will be instructed to use 10 pieces of gum daily for 6 weeks."
16235165|NCT01122238|Behavioral|Motivational Interviewing|"Participants randomized to this condition will receive an initial MI counseling session during the in-person clinic visit followed by three counseling phone calls over the 6-week intervention period (a total of four intervention contacts). The phone counseling sessions will occur during weeks 2, 4, and 6. Case managers will engage the participant in a series of motivation building exercises such as reviewing feelings and thoughts about the pros and cons of quitting and smoking, reinforcing the positives of quitting, helping to dispel myths and concerns about the negatives of quitting, and posing questions about the good aspects of smoking."
16235166|NCT01122238|Behavioral|Smoking Reduction|Participants randomized to Smoking Reduction will receive an initial counseling session during the in-person visit followed by 6 weekly phone counseling sessions over the 6-week intervention period. During the initial session, participants will be told that the goal is to reduce cigarette consumption by 50% over the course of the intervention (approximately 10% reduction per week). During the initial meeting and subsequent counseling calls, case managers will work with participants to problem-solve strategies for reduction (e.g., increasing time between cigarettes, delaying smoking, or eliminating smoking in specific situations). Participants will be asked to record information in a provided smoking log to help keep track of daily smoking patterns and as a feedback mechanism for identifying successes and challenges.
16235167|NCT01122238|Other|No Intervention|No Intervention
16235168|NCT01122238|Drug|Nicotine Patch + Nicotine Gum|"If randomized to both the Nicotine Patch and the Nicotine Gum conditions:
~Participants randomized to this condition will receive a 6-week supply of 14 mg patches and a 6-week supply of 2 mg gum at the initial visit. Participant will be instructed to use one patch daily and to use 10 pieces of gum daily for 6 weeks."
16235169|NCT01122199|Drug|RAD001 + AMG479|Escalating doses of RAD001 + AMG479. Starting cohort will be 5 mg RAD001 once daily, continuous + AMG479 12 mg/kg on Day 1 and 15 of each 28 day cycle.
16235170|NCT01122186|Behavioral|Motivational Interviewing + Cognitive Behavioral Skills Training|The first two sessions will be primarily Motivational Interviewing and begin with an introduction to the nature of treatment, emphasizing the client's autonomy, and explain that the purpose of the sessions is to explore feelings about their medication adherence, meth use, and any other issues, with the eventual goal of working towards any changes the client may wish to make. During the third session, the client will complete an individualized functional analysis of recent occasions when the client missed medication, used MA and/or other substances, and engaged in risky sex (not necessarily all at the same time). Sessions four through seven will focus on Cognitive Behavioral Skills Training for adherence, reducing or stopping meth use, reducing or stopping the combination of meth and other drug use, and avoiding risky sexual behavior. The final session emphasizes maintenance of behavior change and relapse prevention.
16235171|NCT01122186|Behavioral|Education Attention Control|"During the first two sessions participants watch the documentary Rock bottom to receive information on Crystal Methamphetamine, and the possible interactions between HIV medications and recreational substances. Sessions 3 and 4 focus on the importance of medication adherence, viral replication and mutation, and resistance. Session 5 focuses on the negative effects of several recreational substances as well as the negative effects of mixing substances. Session six discusses HIV stigma, transmission risk sexual behavior, and HIV disclosure. Session 7 revisits medication adherence, focusing on dealing with medication side effects and communicating with health care providers. The final session uses part of the documentary Meth which highlights issues of methamphetamine use through interviews with men in various stages of recovery."
16235172|NCT01122173|Device|Ablation|Atrial fibrillation ablation procedure
16235173|NCT01122160|Drug|omeprazole|omeprazole 20.6 mg tablet with berries (blackberries + strawberries)
16235174|NCT01122160|Drug|placebo|Placebo with berries (blackberries + strawberries)
16235175|NCT01122147|Drug|chamomilla tincture mouthwash|The patient is directed to mouth wash chamomilla tincture lightly three times a day,ten drops for each time,until ulcers completely heal
16235176|NCT01122147|Drug|placebo mouthwash|The patient is directed to use placebo mouthwash three times a day, ten drops for each time,until the ulcers completely heal
16235177|NCT01122134|Drug|intravenous artesunate|Intravenous artesunate in a dose of 2.4 mg/kg at start of treatment, 2.4 mg/kg 12 hours later and 2.4 mg/kg/day until the patient is able to tolerate oral therapy. The minimum duration of IV treatment will be 24 hours.
16235178|NCT01122121|Drug|Leuprorelin SR|Leuprorelin SR injection
16235179|NCT01122121|Radiation|Radiotherapy|Radiotherapy 70 +/- 4 Gy
16235180|NCT01122121|Drug|Flutamide|Flutamide tablets
16235181|NCT01122108|Drug|Cholestyramine|Cholestyramine 12 grams, one time dose
16235182|NCT01122108|Drug|Colesevelam HCl|Colesevelam HCl, 4 grams, one time dose
16235183|NCT01122082|Behavioral|food preloads|Subjects will eat in the morning during breakfast 300g cottage cheese (627kJ - 147kcal; 13.2g carbohydrate, 0.3g fat, 23g protein) plus, according to the situations, either: 90g sucrose, HCB); 6g aspartame; 40g vegetable oil; 40g paraffin oil. Therefore two breakfast will have the same energy content (2072kJ - 495kcal), as did the other two(565 kJ - 135kcal).
16235184|NCT01122069|Other|Perflutren Lipid Microsphere ultrasound contrast|Perflutren Lipid Microsphere ultrasound contrast 0.01 ml/kg administered as intravenous bolus
16235185|NCT01122056|Other|Physical exercise training|Two 2-hours long interactive training to perform safe and efficient aerobic exercise for patients with multiple sclerosis
16235186|NCT01122043|Device|Endoglide|Device
16235187|NCT01122030|Drug|Naldemedine|Tablets or solution for oral administration
16235188|NCT01122030|Drug|Placebo|Tablets or solution for oral administration
16235189|NCT01122017|Procedure|Retro-Tubercle Opening-Wedge High Tibial Osteotomy|Retro-Tubercle Opening-Wedge High Tibial Osteotomy (ROWHTO) is among the latest approaches for the treatment of varus deformity of knee.
16235190|NCT01122004|Drug|Pregabalin|
16235191|NCT01122004|Drug|Pregabalin|
16235192|NCT01121991|Drug|Recombinant Human-Luteinizing Hormone (Luveris)|Recombinant Human-Luteinizing Hormone (Luveris) was administered once daily subcutaneously at a starting dose of 150 IU per day beginning on stimulation Day 6.
16235193|NCT01121978|Procedure|Early vitrectomy|Triamcinolone acetonide assisted pars plana vitrectomy with Indocyanine green dye assisted internal limiting membrane peeling
16235194|NCT01121965|Procedure|Pars plana vitrectomy with ILM peeling|Pars plana vitrectomy with ILM peeling
16235195|NCT01121952|Other|Chiropractic (HVLA) manipulation|Single high-velocity, low-amplitude (HVLA long axis) thrust manipulation to the talo-crural joint, once a week during a three week period
16235196|NCT01121939|Drug|Bevacizumab|"15 mg/kg IV Day 1. The first dose should be administered over
~90 minutes. If no adverse reactions occur after the initial dose, the second dose should
~be administered over a minimum of 60 minutes. If no adverse reactions occur after the
~second dose, all subsequent doses should be administered over a minimum of 30
~minutes. Bevacizumab will be infused prior to pertuzumab."
16235197|NCT01121939|Drug|Pertuzumab|"840 mg IV loading dose infused over 60 minutes. The loading dose is given on Cycle 1, Day 1 or as below. Subsequent doses of pertuzumab are 420 mg IV. If the patient tolerates the initial infusion over 60 minutes, the patient may receive subsequent infusions over 30 minutes. Otherwise, pertuzumab should be infused over 60 minutes. Patients should be observed for 30 minutes after completing the pertuzumab infusion.
~If a patient misses a dose of pertuzumab for 1 cycle (i.e., 2 sequential cycles or administrations are 6 weeks or more apart), a re-loading dose (840 mg) of pertuzumab should be given. If re-loading pertuzumab is administered, subsequent doses of 420 mg will then be given every 3 weeks, starting 3 weeks later."
16235198|NCT01121939|Drug|Sandostatin LAR® Depot|30 mg will be given every 28 days by IM injection. The dose of sandostatin may be increased, at the discretion of the treating physician, if necessary to control symptoms related to tumor secretion of vasoactive peptides.
16235199|NCT01121926|Drug|Trazodone HCl|"Dosage form:
~Extended-release caplets containing 300 mg trazodone HCl and extended-release caplets containing 150 mg trazodone HCl (the 150 mg dosage form was only used for the up and down titration, and was not evaluated in the study).
~Dose regimen:
~75 mg trazodone HCl (½ x 150 mg extended-release caplet) on Days 1 and 11, 150 mg trazodone HCl (one extended-release caplet) on Days 2 and 10, 300 mg trazodone HCl (one extended-release caplet) on Days 3 to 9, each at 23:30 after a fast of at least 4 hours."
16235200|NCT01121926|Drug|Trazodone HCl|"Dosage form:
~Immediate-release tablet containing 100 mg trazodone HCl
~Dose regimen:
~100 mg trazodone HCl (one immediate-release tablet) once (at 23:30) on Days 1 and 11, 100 mg trazodone HCl (one immediate-release tablet) twice (at 23:30 and 11:30) on Days 2 and 10, 100 mg trazodone HCl (one immediate-release tablet) three times daily (at 23:30, 07:30 and 15:30) on Days 3 to 9. Evening doses were administered after a fast of at least 4 hours."
16235201|NCT01121913|Drug|Trazodone HCl|The dosage of trazodone.HCl during this treatment phase was a single oral dose of 300 mg (one CR tablet) at 07:30 (after an overnight fast of at least 10 hours) on clinic days.
16235202|NCT01121913|Drug|Trazodone HCl|The dosage of trazodone.HCl during this treatment phase was a single oral dose of 300 mg (one CR tablet) at 07:30 (after an overnight fast of at least 10 hours) on clinic days.
16235273|NCT01121406|Drug|Topotecan|Patients receive topotecan in 3 or 4 week schedule
16235691|NCT01118611|Radiation|fludeoxyglucose F 18 dynomic contrast|
16235203|NCT01121913|Drug|Trazodone HCl|The dosage of trazodone.HCl during this treatment phase was 2 oral doses of 150 mg each: one controlled-release (CR) tablet at 07:30 (after an overnight fast of at least 10 hours) and 19:30 (after a fast of at least 2 hours) on clinic days.
16235204|NCT01121913|Drug|Trazodone HCl|The dosage of trazodone.HCl during this treatment phase was three oral doses of 100 mg each: one immediate-release (IR) tablet at 07:30 (after an overnight fast of at least 10 hours), 15:30 and 23:30 (both dosages after a fast of at least 2 hours) on clinic days.
16235205|NCT01121900|Drug|Trazodone HCl|"Dosage form: Extended-release caplets containing 300 mg trazodone HCl
~Dose: 300 mg trazodone HCl extended-release caplets (one caplet) at 23:30 on Day 1 of the test product treatment period following a fasting period of at least 4 hours."
16235206|NCT01121900|Drug|Trazodone HCl|"Dosage form: Immediate-release tablets containing 100 mg trazodone HCl
~Dose: 100 mg trazodone HCl immediate-release tablets (one tablet per dosing time) at 23:30 on Day 1, at 07:30 and 15:30 on Day 2 of the reference product treatment period."
16235207|NCT01121887|Behavioral|Standard treatment|"Telephone-based smoking cessation counselling based on a combination of coaching and cognitive behavioural therapy (CBT) techniques. Counsellors are also trained in giving tailored advice regarding the use of smoking cessation aids.
~Clients are offered a choice between reactive treatment (clients initiate all contact) and proactive treatment (counsellors call back at appointed dates). Printed information material tailored to clients' needs is offered free of charge."
16235208|NCT01121887|Behavioral|Motivational Interviewing|"Telephone-based smoking cessation counselling with Motivational Interviewing added to the standard treatment protocol.
~Clients are offered a choice between reactive treatment (clients initiate all contact) and proactive treatment (counsellors call back at appointed dates). Printed information material tailored to clients' needs is offered free of charge."
16235209|NCT01121874|Procedure|Ligament reconstruction with suture fixation system|CMC arthroplasty consisting of reconstruction of the palmar oblique ligament using a suture fixation system
16235210|NCT01121874|Procedure|Ligament Reconstruction with Tendon Interposition (LRTI)|commonly performed CMC arthroplasty technique, consisting of a trapeziectomy, followed by palmar oblique ligament reconstruction using a harvested flexor tendon from the wrist.
16235211|NCT01121874|Procedure|Ligament reconstruction with suture fixation system|CMC arthroplasty consisting of reconstruction of the palmar oblique ligament using a suture fixation system, with a decreased period of immobilization from 6 weeks to 2 weeks.
16235212|NCT01121861|Procedure|Phacoemulsification with implantation of toric IOL|
16235213|NCT01121848|Drug|Leucovorin|"Pharmaceutical form:vials of 50 mg/5 mL or 500 mg/50mL Route of administration: IV
~Dose regimen:"
16235214|NCT01121848|Drug|OXALIPLATIN|"Pharmaceutical form: Lyophilized powder for injection (50 mg/vial or 100 mg/vial) or aqueous solution (50 mg/10 mL and 100 mg/20 mL) Route of administration: IV
~Dose regimen:"
16235215|NCT01121848|Drug|5-Fluorouracil|"Pharmaceutical form: vials of 5 g/100mL Route of administration: IV
~Dose regimen:"
16235216|NCT01121835|Drug|INSULIN GLARGINE|Pharmaceutical form: solution for injection Route of administration: sub-cutaneous injection Dose regimen: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 ml)
16235217|NCT01121835|Drug|INSULIN GLULISINE|Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: 100 Units/mL solution for injection in a pre-filled SoloStar pen (3 mL)
16235218|NCT01121835|Drug|PREMIXED INSULIN|"Pharmaceutical form: solution for injection Route of administration: sub-cutaneous Dose regimen: - 30% soluble insulin aspart and 70 % protamine-crystallised insulin aspart in pre-filled Flexpen for all the countries except Mexico
~25 % insulin lispro solution and 75% insulin lispro protamine in cartridges for Humapen Luxura for Mexico only"
16235219|NCT01121822|Biological|Influenza virus vaccine (split virion, inactivated)|0.5 mL, Intramuscular
16235220|NCT01121822|Biological|Influenza virus vaccine (split virion, inactivated)|0.5 mL, Intramuscular
16235221|NCT01121809|Drug|Raltegravir|Changing the dose of raltegravir from 400 mg bid to 800 mg qd
16235222|NCT01121809|Drug|Etravirine|Changing the dose of etravirine from 200 mg bid to 400 mg qd
16235223|NCT01121796|Dietary Supplement|Vitamin D|
16235224|NCT01121796|Other|Water or milk|
16235225|NCT01121796|Dietary Supplement|Vitamin D enriched milk|
16235226|NCT01121783|Other|Lactisole|A pre-infusion of lactisole solution (0.25mg/ml) is administered as a bolus (1ml/kg bodyweight)via intragastric tube. After 15 minutes a 1M glucose solution is administered as a bolus via intragastric tube.
16235227|NCT01121783|Dietary Supplement|Lactisole|A pre-infusion of lactisole solution (0.25mg/ml)is administered as a bolus (1ml/kg body weight) via intragastric tube. After 15 minutes tap water will be administered as a bolus via the intragastric tube.
16235228|NCT01121783|Dietary Supplement|Lactisole|A pre-infusion of tap water(is administered as a bolus (1ml/kg bodyweight)via intragastric tube. After 15 minutes a 1M glucose solution is administered as a bolus via intragastric tube.
16235229|NCT01121783|Dietary Supplement|Lactisole|A pre-infusion of tap water is administered as a bolus (1ml/kg bodyweight)via intragastric tube. After 15 minutes tap water is administered as a bolus via intragastric tube.
16235230|NCT01121770|Drug|fondaparinux sodium injection|1.5mg subcutaneously every day
16235231|NCT01121757|Drug|azacitidine|Azacitidine 75 mg/m2 SC or IV on days 1-5; subjects will begin Part 2 at the azacitidine dose level tolerated in Part 1a.
16235232|NCT01121757|Drug|lenalidomide|Lenalidomide dose is 15mg po per day on days 1-21; starting dose during Part 2 will depend upon how well the subject tolerated drug during Part 1.
16235233|NCT01121744|Device|Supralimus-Core™ Sirolimus eluting Coronary Stent|Supralimus-Core™ Coronary Stent System consisting of the Coronnium® coronary stent (CE approved) having Biodegradable Polymeric Matrix on a Co-Cr alloy Platform. Sirolimus Drug concentration is 1.4 µg/mm2.
16235234|NCT01121731|Drug|Interferon α-5|3 MIU or safe dose used three times a week (TIW) in alternate days in monotherapy. 29 days of treatment. Subcutaneous injection.
16235235|NCT01121731|Drug|Interferon-α5 plus Interferon-α 2b|Interferon-α5 plus Interferon-α 2b. 1.5 MIU each, or safe dose used TIW in alternate days in combined therapy. 29 days of treatment. Subcutaneous injection.
16235236|NCT01121731|Drug|Interferon α-2b (INTRON® A)|3 million IU TIW in alternate days in monotherapy. 29 days of treatment. Subcutaneous injection.
16235237|NCT01121718|Drug|ICG Intervention|NIR-guided sentinel lymph node mapping with indocyanine green (ICG)
16235238|NCT01121705|Drug|Peg Interferon alpha2b + Ribavirin|"B 1 I or II: Experimental
~variable duration of treatment group according with RVR. In case of RVR present patients will be treated for 12 weeks. Patients without RVR will be treated for 24 (B1I) or 36 (B1II)weeks: different duration of treatment for patients without RVR"
16235239|NCT01121692|Behavioral|Couples Intervention|The Couples intervention is a merged intervention of three interventions (Women CoOp, men as partners's and couples). Couples attend together for two half day workshops and work on exercises on communication and problem solving, including a commitment pledge of fidelity.
16235240|NCT01121692|Behavioral|Women's CoOp|The Women's CoOp is a gender-focused intervention discussing women's risk in relationship to HIV and also discusses issues of HIV with South African women including skills for violence prevention. During this intervention, participants will also demonstrate the proper use of male and female condoms on penile and vaginal models. They attend two half day workshops.
16235241|NCT01121692|Behavioral|Women's CoOp and Men's Intervention|The Men's CoOp is adapted from Men as Partners, the Women's CoOp and the Couples intervention and contain similar material with a concentration on gender roles and violence prevention. Men attend two half day workshops.
16235242|NCT01121666|Drug|Follitropin alfa|150IU per day subcutaneously for a maximum of 16 days
16235243|NCT01121653|Drug|Magnogene ® (magnesium)|evaluate on pain scores (neuropathic pain questionnaire and pain numeric scale) and on quality of life, the effect of oral magnesium intake on patients with neuropathic pain comparing with patients receiving placebo,. The study drug will be taken during 4 weeks.
16235244|NCT01121640|Procedure|CA125 assay on Abbott Architect i1000SR platform|Bead-based sandwich ELISA style assay
16235245|NCT01121640|Procedure|HE4 assay on Architect i1000SR platform|Bead-based sandwich ELISA style assay
16235246|NCT01121640|Procedure|Transvaginal Ultrasound|Sonogram will be obtained only if confirmatory markers are elevated. Exam is restricted to ovarian evaluation.
16235247|NCT01121627|Other|Computerized cognitive training|A 12 week computerized cognitive training at home with the Attengo™ software program.
16235248|NCT01121614|Device|LOTUS|Device used to seal blood vessel
16235249|NCT01121614|Device|Ethicon Harmonic Scalpel|
16235250|NCT01121614|Device|LigaSure bipolar vessel sealing device|
16235251|NCT01121601|Procedure|hepatic surgery of resection|after metastasis liver resection , Coseal will be administered at 4 mL by dose, administration of 1 to 3 dose in fontion of liver adherence Coseal will be administered by spray at 5 to 10 cm of liver.
16235252|NCT01121601|Procedure|hepatic surgery of resection|this is a liver metastasis resection according to liver chirurgical guidelines study drug not administered in this group
16235253|NCT01121588|Drug|Crizotinib|Crizotinib tablets, 250 mg BID, will be administered orally on a continuous dosing schedule
16235254|NCT01121575|Drug|PF-02341066|Arm 1: The starting dose will be 200 mg by mouth, twice a day of PF 02341066 in tablet form The dose of each drug in the combination [PF-02341066 and PF-00299804] will be escalated or de-escalated until the maximum tolerated combined dose is reached. Patients will then be treated with the maximum tolerated combined dose.
16235255|NCT01121575|Drug|PF-00299804|Arm 1: The starting dose will be 30 mg by mouth once a day of PF-0029804 in tablet form. The dose of each drug in the combination [PF-02341066 and PF-00299804] will be escalated or de-escalated until the maximum tolerated combined dose is reached. Patients will then be treated with the maximum tolerated combined dose.
16235256|NCT01121575|Drug|PF-02341066|Arm 2: With progressive disease the maximum tolerated combined dose of PF-02341066 (given by mouth twice a day in tablet form) and PF-00299804 (given by mouth once a day in tablet form).
16235257|NCT01121575|Drug|PF-00299804|Arm 2: The dose of 45 mg by mouth once a day of PF-00299804 in tablet form until progressive disease and then the maximum tolerated combined dose of PF-02341066 (given by mouth twice a day in tablet form) and PF-00299804 (given by mouth once a day in tablet form).
16235258|NCT01121562|Drug|Sunitinib|Sunitinib capsule will be given orally at continuous daily dosing with a dose of 37.5 mg in the morning (regardless fasting or non-fasting, One cycle will be 28days)
16235259|NCT01121549|Drug|Aromasin|25 mg daily continuously
16235260|NCT01121536|Drug|Armodafinil|Armodafinil tablets, taken orally, once daily in the morning
16235261|NCT01121523|Behavioral|Cue directed tactile stimulation|Cue-based tactile stimulation delivered to medically stable premature infants three times daily by mothers or trained NICU nurses daily for 4 consecutive weeks
16235262|NCT01121510|Device|closure device|the invasive specialist must carefully manage the difficult balance of patient anticoagulation and coagulation for stopping the bleeding at the femoral artery puncture site. the QuickClose design 9 system is designed to benefit the patients and the medical staff by improving the process. the risks to patients associated with this study are considered reasonable in comparison to the anticipated benefits to the subjects, and the scientific knowledge that can be gained from the study.
16235263|NCT01121497|Drug|Physostigmine|Intravenous bolus of physostigmine 1 mg, 3-5 minutes before completion of the colonoscopy procedure
16235264|NCT01121484|Drug|desvenlafaxine succinate sustained-release|50-mg DVS SR tablets taken orally once daily.
16235265|NCT01121484|Drug|placebo|Placebo tablets taken orally once daily.
16235266|NCT01121471|Dietary Supplement|Conjugated Linoleic Acid (CLA)|6.4 g CLA/day, capsule form, for 16 week arms
16235267|NCT01121471|Dietary Supplement|Safflower OIl|8.0g/day safflower oil
16235268|NCT01121458|Drug|Clevidipine|The clevidipine infusion is to be administered via IV infusion at a starting dose of 0.5 mg/hour. The dose may be doubled every three (3) minutes to a maximum dose of 32 mg/hr as tolerated, until a 20% reduction in PVR is achieved or until the patient experiences hypotension (SBP< 80 mmHg), hypertension (SBP>150 mmHg), tachycardia (120 beats per minute), bradycardia (<50 beats per minute), or symptoms of hypotension or ischemia (chest pain, anxiety, nausea, vomiting), allergic reaction (hives, urticaria) or other adverse event. Clevidipine infusion may be terminated at any time for a safety reason or at the investigator's discretion.
16235269|NCT01121445|Device|NeilMed nose and sinus irrigation|Saline irrigation used daily plus CPAP with heated humidification for 4 weeks
16235270|NCT01121432|Procedure|endobronchial ultrasound-guided transbronchial needle aspiration|One time for aspiration/biopsy. The duration about 1-2 hour.
16235271|NCT01121406|Drug|Paclitaxel|Patients receive paclitaxel in a 4 week schedule
16235272|NCT01121406|Drug|Gemcitabine|Patients receive gemcitabine in a 3 week schedule
16235274|NCT01121406|Drug|Pegylated liposomal doxorubicin (PLD)|Patients receive PLD in a 4 week schedule
16235275|NCT01121406|Drug|BI 6727|Patients receive BI 6727 infusion every 3 weeks
16235276|NCT01121393|Drug|Gemcitabine+Cisplatin|Gemcitabine d1,8, Cisplatin d1, 21 days as a course, up to 6 courses.
16235277|NCT01121393|Drug|BIBW 2992|starting dose is 40 mg, in the event of no or minimal drug-related adverse events after one course, the dose will be increased to 50mg. in the event of certain drug related Adverse Event (AE), dose reduction will be increments of 10 mg, with the lowest dose being 20mg.
16235278|NCT01121380|Drug|BL-1021|"BL-1021 is an orally available NCE which contains an elongated aliphatic side-chain.
~Dosage:
~Part 1 - Single Dose: 1 dose on Day 1, dosage will be 10, 20, 40 & 80 mg according the cohort Part 2 - Multiple Dosing: up to 7 once-daily administrations. Dosage will be determined according the first part results."
16235279|NCT01121380|Drug|1021|1021
16235280|NCT01121354|Drug|Cefazolin 2g for Injection USP and Dextrose Injection USP|Cefazolin 2g for Injection USP and Dextrose Injection USP in the DUPLEX® Drug Delivery System. Administration will occur three times per day (t.i.d.) over an eleven (11) day period, with nine (9) days of repeated dosing.
16235281|NCT01121354|Drug|Cefazolin 1.5g|Cefazolin 1.5g for Injection USP and Dextrose Injection USP in a pharmacy-prepared container. Administration will occur four times per day (q.i.d.) over an eleven (11) day period, with nine (9) days of repeated dosing.
16235282|NCT01121341|Procedure|Vein harvesting|Endoscopic versus conventional vein harvesting
16235283|NCT01121328|Biological|Autologous cord blood transfusion for preterm neonates|Cord blood collection after delivery of the baby. Preservation of blood in blood bank. Transfusion of blood within the first 14 postnatal days to maintain Hb level above 10gm%.
16235284|NCT01121328|Biological|Autologous cord blood transfusion|"After delivery of the baby and before placental delivery in vaginal delivery. After delivery of the baby the placental will be taken out in cesarean section. sterilization of the umbilical cord will be done. Puncture of the umbilical cord vein with the needle of blood transfusion bag will be done.
~Blood will be kept in the blood bank. Blood grouping, haematocrit and CBC will be done for the cord blood.Maternal sample will be analysed simultaneously.
~Mononuclear layer will be separated within 6 hours and transfused to the preterm neonate immediately.
~RBCs will be separated and kept till need (Hb less than 10 gm%)."
16235285|NCT01121302|Drug|AZD5213|0.1 mg, 0.3 mg, 1 mg, 2 mg, 4 mg, 8 mg, 16 mg, 32 mg oral solution, single ascending doses
16235286|NCT01121302|Drug|Placebo|
16235287|NCT01121289|Drug|NN1218|0.2 U/kg body weight injected subcutaneously (under the skin)
16235288|NCT01121289|Drug|insulin aspart|0.2 U/kg body weight injected subcutaneously (under the skin)
16235289|NCT01121289|Drug|NN1218|0.2 U/kg body weight injected subcutaneously (under the skin)
16235290|NCT01121289|Drug|NN1218|0.4 U/kg body weight injected subcutaneously (under the skin)
16235291|NCT01121289|Drug|NN1218|0.2 U/kg body weight injected subcutaneously (under the skin)
16235292|NCT01121289|Drug|NN1218|0.2 U/kg body weight injected subcutaneously (under the skin)
16235293|NCT01121276|Drug|Faster-acting insulin aspart|0.2 U/kg body weight injected subcutaneously (under the skin)
16235294|NCT01121276|Drug|insulin aspart|0.2 U/kg body weight injected subcutaneously (under the skin)
16235295|NCT01121276|Drug|Faster-acting insulin aspart|0.2 U/kg body weight injected subcutaneously (under the skin)
16235296|NCT01121276|Drug|Faster-acting insulin aspart|0.2 U/kg body weight injected subcutaneously (under the skin)
16235297|NCT01121276|Drug|Faster-acting insulin aspart|0.2 U/kg body weight injected subcutaneously (under the skin)
16235298|NCT01121250|Behavioral|Telephone Discussion Groups|Each telephone discussion group will meet 12 times during six months. The one-hour calls will be semi-structured conference calls with education, training in coping skills and cognitive restructuring, and support. A Participant Workbook will include comprehensive materials for all sessions and topics, other resources, and red flag resources - areas that may exacerbate problems, add a level of difficulty or distress, and/or indicate a need for referrals (e.g., unsafe behaviors, substance abuse, spouse abuse, PTSD, depression, traumatic brain injury).
16235299|NCT01121250|Behavioral|Education sessions|Participants will have 12 sessions (delivered using slides and telephone) that cover the same education content, without skills building or support, over six months. They will also receive the Participant Workbook.
16235300|NCT01121237|Drug|Recombinant human erythropoietin alfa (biosimilar)|Recombinant human erythropoietin alfa (biosimilar) commercially available as prescribed per treating physician
16235301|NCT01121224|Device|Bare Metal Stent|Patients receive one or more bare metal stents in the saphenous vein graft target lesion.
16235302|NCT01121224|Device|Drug-Eluting Stent|Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion.
16235303|NCT01121224|Drug|Blinded clopidogrel|For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion.
16235304|NCT01121224|Drug|Placebo|For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS.
16235305|NCT01121224|Drug|Thienopyridine (open-label)|For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
16235306|NCT01121211|Drug|Testosterone|Testosterone 300mcg transdermal patch x 24 weeks.
16235307|NCT01121211|Drug|Placebo|Placebo transdermal patch x 24 weeks
16235308|NCT01121198|Drug|ASP1941|oral
16235309|NCT01121198|Drug|placebo|oral
16235310|NCT01121185|Biological|MBL-HCV1|50 mg/kg MBL-HCV1, intravenous
16235311|NCT01121185|Other|0.9% Sodium chloride Placebo|0.9% sodium chloride, intravenous
16235312|NCT01121159|Procedure|orbital fracture repair|All patients will receive orbital fracture repair with one of the 4 specified implants
16235313|NCT01121146|Device|Total Hip Replacement|Comparison of Marathon and Enduron polyethylene
16235314|NCT01121133|Drug|navitoclax|Subjects will be dosed with Navitoclax, then dosed with Navitoclax in combination with Rifampin.
16235315|NCT01121133|Drug|Rifampin|Subjects will be dosed with Navitoclax, then, dosed with Navitoclax in combination with Rifampin.
16235316|NCT01121120|Drug|TXA127|300mcg/kg/day, administered subcutaneously for up to 28 days
16235355|NCT01120730|Drug|fluid resuscitation|fluid resuscitation with HES
16235317|NCT01121120|Drug|Placebo|300mcg/kg/day administered subcutaneously for up to 28 days
16235318|NCT01121107|Device|Left Atrial Pressure Monitoring System|Left atrial lead is placed for ambulatory monitoring of left atrial pressure
16235319|NCT01121107|Device|Patient Advisory Module|Handheld device that provides medication reminders
16235320|NCT01121081|Drug|Alga Dunaliella Bardawil|4 capsules per day, 2 in the morning 2 in the evening for 3 month
16235321|NCT01121081|Drug|Placebo|"Drug: Alga Dunaliella Bardawil
~4 capsules per day, 2 in the morning 2 in the evening for 3 month"
16235322|NCT01121068|Other|Blood samplings|About 3.5ml of blood will be drawn from the participants monthly.
16235323|NCT01121055|Drug|Lorazepam|Lorazepam 0.5mg po at night one day before FB and Lorazepam 1mg po 30min before the FB
16235324|NCT01121055|Drug|Control|Placebo 1T po at night one day before FB and placebo 1T po 30min before the FB
16235325|NCT01121042|Drug|Ondansetron|8mg per day oral capsule
16235326|NCT01121042|Drug|Placebo|daily oral capsule matched to active study medication. Made form 100% lactose powder
16235327|NCT01121029|Procedure|Autologous hematopoietic stem cell transplantation|Patients will receive a stimulation with filgrastim 10mcg/Kg per day during 4 days and cyclophosphamide 1.5g/m2 per day during 2 days and mesna 300mg/m2 i.v. in 4 hours for prophylaxis (uroprotection). Lately, the stem cells will be recollected by apheresis. After that, the patients will receive a conditioning regimen with cyclophosphamide 500mg/m2 per day during 4 days and fludarabine 30mg/m2 per day during 4 days. After the last dose of cyclophosphamide, the autologous hematopoietic stem cell transplantation will be done on day 0, by peripheral vein. Then, a standard regimen of prophylaxis with oral ciprofloxacin 500mg every 12 hours, acyclovir 400mg every 8 hours, fluconazole 100mg per day and omeprazole 20mg per day for the recovery time of each patient.
16235328|NCT01121016|Drug|Montelukast|10mg, qn, 4 weeks
16235329|NCT01121016|Other|placebo to montelukast|same appearance, flavor, weight, and size to montelukast pills, 1 pill daily, for 4 weeks
16235330|NCT01121003|Behavioral|weight maintenance, low sugar diet|
16235331|NCT01121003|Behavioral|weight maintenance, high fructose diet|
16235332|NCT01121003|Behavioral|weight maintenance, high fructose diet+ exercise|
16235333|NCT01120990|Other|Blood Pressure Measurement|All patients have their blood pressure measured simultaneously by two observers using parallel connected mercury sphygmomanometers and by a supervisor using the tested device, NISSEI DM 3000. Six sets of measurements are performed.
16235334|NCT01120964|Drug|Intravenous L-Citrulline|150mg bolus X 1 after initiation of cardiopulmonary bypass, the addition of L-citrulline at a concentration of 200 umol/L or placebo to the filtration and hemoconcentration fluid utilized during cardiopulmonary bypass in addition to a 20mg/kg bolus 30 minutes after separation from cardiopulmonary bypass immediately followed by a continuous infusion of 9mg/kg/hr IV, and ending at 48 hours continuous infusion or discharge from the PCCU.
16235335|NCT01120964|Drug|Placebo of Intravenous L-Citrulline|Placebo of Intravenous L-Citrulline given at the same prescribed times as L-Citrullne Drug
16235336|NCT01120925|Biological|MNC|2-3 X 109 cells in 20ML suspension IPV in 4 min
16235337|NCT01120925|Biological|CD133|5-15 X 106 cells in 20ML suspension IPV
16235338|NCT01120925|Biological|Control|Injection of 20 ml Normal saline via IPV
16235339|NCT01120912|Drug|Oshadi Oral Insulin|Oral insulin single administration
16235340|NCT01120899|Drug|Minocycline|Participants take 100 mg minocycline pills twice daily for 24 months.
16235341|NCT01120873|Drug|Metamin 3D|Metamin 3D is composed by red yeast rice, bitter gourd, chlorella, soy peptide and licorice extract is a commercial product designed by Uni-President enterprises corp in Taiwan
16235342|NCT01120860|Device|MRI|MRI - routine imaging sequences, designed for anatomical quantification
16235343|NCT01120834|Drug|azacytidine|"Dose level 1: azacitidine 55 mg/m2 on days 1-5
~Dose level 2: azacitidine 75 mg/m2 on days 1-5
~Dose level 3: azacitidine 55 mg/m2 on days 1-5
~Dose level 4: azacitidine 75 mg/m2 on days 1-5
~Each cycle = 28 days. Subjects may receive up to 6 cycles."
16235344|NCT01120834|Drug|vorinostat|"Dose level 1: oral vorinostat at 300 mg BID on Days 1-7.
~Dose level 2: oral vorinostat at 200 mg BID on Days 1-7.
~Dose level 3: oral vorinostat at 300 mg BID on Days 1-14.
~Dose level 4: oral vorinostat at 200 mg BID on Days 1-14.
~Each cycle = 28 days. Subjects receive up to 6 cycles."
16235345|NCT01120821|Drug|Gleevec|400 mg once daily for 12 months
16235346|NCT01120808|Procedure|Paper tape|Paper tape assigned to each participant's randomly selected foot.
16235347|NCT01120795|Drug|Pegylated interferon and ribavirin|Pegylated interferon 180 ug subcutaneous per week Ribavirin 1000-1200 mg /day for genotype 1 and 800 mg /day orally for genotype non 1 Duration: 48 weeks for genotype 1 and 24 weeks for gentoype non 1
16235348|NCT01120795|Drug|Pegylated interferon and ribavirin|Pegylated interferon 180 ug/ week subcutaneously Ribavrin 1000-1200 mg /day for genotype 1 and 800 mg/day orally for genotype 2 and 3 Treatment duration 48 weeks for genotype 1 and 24 weeks for genotypes 2 and 3
16235349|NCT01120782|Device|etafilcon A toric contact lens with new wetting agent|Investigational toric contact lens made of etafilcon A material with a new wetting agent.
16235350|NCT01120782|Device|etafilcon A toric contact lens|Marketed toric contact lens made of etafilcon A material.
16235351|NCT01120769|Drug|Acetaminophen|single dose
16235352|NCT01120769|Drug|Placebo|single dose
16235353|NCT01120756|Behavioral|Goal-oriented attentional self-regulation|This will involve 5-7 weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of home practice). In brief, the GBSM training protocol is designed to maximize the potential for improving attention regulation skills and the goal-directed functions they support, applying mindfulness-based attention regulation training to practice in redirecting attention to goal-relevant processes especially in the context of distractions is emphasized throughout training. Participants are asked to identify realistic functional goals as feasible individual and group projects, and are then trained in goal management strategies on the functional task(s) of their choice.
16235354|NCT01120756|Behavioral|Brain Health Education|Brain Health Education (EDU) will involve 5-7 weeks of training (20 hours of group training (2 hour sessions, 2 days per week), 3 hours of individual training (1 hour at the beginning, halfway through and at the end of training), and approximately 20 hours of homework). The EDU intervention involves education in health and brain injury in a classroom format, with study materials for homework.
16235356|NCT01120730|Drug|Fluid resuscitation|Fluid resuscitation in standardized fashion
16235357|NCT01120717|Drug|QVA149|capsules for inhalation, delivered by an SDDPI
16235358|NCT01120717|Drug|Placebo|capsules for inhalation, delivered by an SDDPI
16235359|NCT01120704|Drug|Short Term Combination Nicotine Replacement Therapy (patch + gum)|"IF participant smokes >10 cigs/day AND is randomized to a 8 week condition: they will be asked to take one 21 mg patch/day for 4 weeks, THEN one 14 mg patch/day for 2 weeks, THEN one patch 7mg/day for 2 weeks.Participants will also be asked to use 4-mg gum every 1-2 hours (9 pieces maximum per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment.
~IF participant smokes 5-10 cigs/day AND is randomized to the 8 week medication condition: they will be asked to take one 14 mg patch/day for 4 weeks, THEN one 7 mg patch/day for 4 weeks. Participants will also be asked to use 2-mg gum every 1-2 hours (9 pieces max per day)for 6 weeks and decrease gum use over the 2 weeks prior to medication termination until down to one gum piece every 4-8 hours by the last week of treatment."
16235360|NCT01120704|Drug|Long Term Combination Nicotine Replacement Therapy (patch + gum)|"IF the participant smokes >10 cigs/day AND is randomized to a 26 week medication condition: they will be asked to take one 21 mg patch per day for 22 weeks, THEN one 14 mg patch per day for 2 weeks, THEN one patch 7 mg patch per day for 2 weeks. Participants will also be asked to use one piece of one 4-mg- gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication termination until they are down to one gum piece every 4-8 hours by the last week of treatment.
~IF the participant smokes 5-10 cigs/day AND is randomized to a 26 week medication condition: they will be asked to take one 14 mg patch per day for 22 weeks, THEN one patch 7 mg patch per day for 4 weeks. Participants will also be asked to use one piece of 2-mg gum every 1-2 hours (9 pieces maximum per day)for 24 weeks and decrease gum use over the 2 weeks prior to medication termination until they are down to one gum piece every 4-8 hours by the last week of treatment."
16235361|NCT01120704|Behavioral|Intensive Maintenance Counseling|Participants randomized to this condition will receive eight 15-minute phone counseling sessions at Weeks 3, 4, 6, 8, 10, 14, 18 & 22. The counseling will encourage continued practice of coping skills, and avoidance of danger situations. Another emphasis will be the continued provision of social support as a means of enhancing motivation. Participants who have relapsed will receive counseling aimed at motivating and planning renewed quit attempts. Other aims are enhancing motivation, especially competence self-appraisals, providing intratreatment support, and encouraging pleasurable activities.
16235362|NCT01120704|Behavioral|Cognitive Medication Adherence Counseling (CAM)|Participants randomized to this condition will be given a brief (10 minute) session of CAM treatment at both Visits 1 and 2. CAM will include information on NRT such as the following: NRT reduces withdrawal and urges; sustained use reduces the likelihood of relapse; willpower and medication make a good combination; NRT will help a lapsing smoker reachieve abstinence. The tailored counseling component of the CAM intervention is based on brief evaluation of the smoker's beliefs, concerns, and possible misconceptions about smoking cessation medications.
16235363|NCT01120704|Behavioral|Electronic Medication Monitoring Device (the Helping Hand) + Feedback|If randomized to this condition, the case manager will give patients a computer-generated feedback sheet showing the patient's medication self-administration since the last visit. The case manager will provide problem-solving counseling regarding barriers to medication use. This problem-solving counseling intervention will be given in brief in-person sessions (three in-person sessions for those in the 8 week medication condition and five in-person sessions for those in the 26 week medication condition). Medication monitoring counseling will also occur via phone (two 10-minute sessions for those in the 8 week medication condition and four 10-minute sessions for those in the 26 week medication condition).
16235364|NCT01120704|Behavioral|Automated Adherence Prompting Phone Calls|"Participants in this condition will receive fully automated prompts with messages designed to encourage participants to take their medication.
~Adherence prompting calls will occur two times in the first week of the quit attempt, and then once a week in weeks 2, 3, 4, 5, and 7. Those in the 26-Week medication condition who are assigned to the active adherence prompting calls intervention, will receive one prompting call a week during Weeks 11, 15, 19 & 23."
16235365|NCT01120691|Drug|QVA149|QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks).
16235366|NCT01120691|Drug|NVA237|NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks).
16235367|NCT01120691|Drug|tiotropium|Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks).
16235368|NCT01120691|Drug|Salbutamol/albuterol|As needed throughout the study
16235369|NCT01120665|Drug|Estradiol valerate|estradiol valerate, 1 mg/day, orally.
16235370|NCT01120665|Other|Aerobic training|Aerobic trainin (cycleergometer, 3x/week, moderate intensity, 50 minutes)
16235371|NCT01120665|Drug|Placebo|lactose powder, corn starch, microcrystalline cellulose, and magnesium stearate
16235372|NCT01120665|Other|Control|The control group was advised to maintain their normal habits, and not to begin any physical exercise program during the study period
16235373|NCT01120652|Behavioral|Mind-Body Skills Training (MBST)|This is a behavioral intervention that blends cognitive-behavioral therapy methods, mind-body relaxation training, and mindfulness practices. MBST is provided in 8 individual sessions, each lasting approximately one hour. Ideally, sessions take place on a weekly basis, so that the intervention phase of the study lasts for approximately two months.
16235374|NCT01120652|Behavioral|Supportive Counseling (SC)|This is a behavioral intervention consisting of support and symptom monitoring but without specific skills training or provision of advice. SC is provided in 8 individual sessions, each lasting approximately one hour. Ideally, sessions take place on a weekly basis, so that the intervention phase of the study lasts for approximately two months.
16235375|NCT01120639|Drug|Temozolomide|75 mg/m²/day oral, administered concurrently with radiotherapy and as adjuvant therapy.
16235376|NCT01120639|Procedure|Stereotactic Radiosurgery (SRS)|Standard of care therapeutic radiotherapy administrated at 25, 30, 35, or 40 Gray (Gy)
16235377|NCT01120626|Drug|donepezil|donepezil (2.5 mg to 10.0 mg per day for 12 weeks)
16235378|NCT01120626|Drug|sugar pill|sugar pill (2.5 mg to 10.0 mg per day for 12 weeks)
16235379|NCT01120613|Drug|Chronotherapy|"Patients identified with nocturnal hypertension while treated with blood pressure medications will have one medication switched from daytime to night time dosing in the following preference:
~ACE or ARB
~Calcium Channel Blockers
~Alpha Blocker
~Beta Blocker
~If patient is on only one daytime BP medication, it will be switched to night time dosing. No dose adjustments will be made nor any new medications will be added. Only timing of BP medication will be changed."
16235380|NCT01120600|Drug|Odanacatib|One 50 mg tablet once weekly
16235381|NCT01120600|Drug|Placebo for Odanacatib|One 50 mg tablet once weekly
16235382|NCT01120600|Dietary Supplement|Vitamin D3|5600 IU of open-label Vitamin D3 once weekly
16235383|NCT01120600|Dietary Supplement|Calcium carbonate|Sufficient amount of open-label calcium carbonate so that daily calcium intake from both dietary and supplementary sources in approximately 1200 mg
16235384|NCT01120574|Other|Home mechanical ventilation|Home mechanical ventilation will be performed with a bilevel pressure ventilator.
16235385|NCT01120561|Drug|trastuzumab-MCC-DM1|Intravenous repeating dose
16235386|NCT01120548|Other|ventilation therapy|"The service provider will provide the patient with the ventilation device and will explain to the patient how to operate the device and how to fit the mask according to the specifications.
~There will be an oximetry recording during ventilation on the first night. After the first night, the ventilation parameters recorded by the machine and the oximetry results will be read and used to adjust the settings.
~Starting the first week and at the end of the programme, the following ventilation parameters will be collected: compliance, leaks, AHI, ventilation mode, pressures used. The threshold of length of nocturnal ventilation fixed to 3h per night on average in order to consider a compliant patient."
16235387|NCT01120535|Device|Inferior Vena Cava Filter|Inplant of filter in inferior vena cava.
16235388|NCT01120522|Device|Inferior Vena Cava Filter|Inplant of filter in inferior vena cava.
16235389|NCT01120509|Device|Inferior Vena Cava Filter|Inplant of filter in inferior vena cava.
16235390|NCT01120496|Drug|3% hypertonic saline|Moderately to severely ill infants with bronchiolitis were randomized to receive 4 mL solution containing either 3% hypertonic saline or normal saline
16235391|NCT01120496|Drug|normal saline|Moderately to severely ill infants with bronchiolitis were randomized to receive 4 mL solution containing either 3% hypertonic saline or normal saline
16235392|NCT01120470|Drug|OGX-427|OGX-427: Starting within 5 days of randomization, three loading doses at 600 mg IV within the first 10 days of initiating treatment, followed by weekly doses of 1000 mg IV
16235393|NCT01120470|Drug|Prednisone|"Control Arm:
~Prednisone: 5 mg BID orally starting within 4 days following randomization
~Experimental Arm:
~Prednisone: 5 mg BID orally starting within 4 days following randomization and at least 24 hours prior to first loading dose of OGX-427"
16235394|NCT01120457|Drug|BMS-936564 (Anti-CXCR4)|
16235395|NCT01120444|Device|BD Research Catheter with 34G x 1.5 mm needle|bolus injection of insulin given intradermal prior to standardized meal
16235396|NCT01120444|Device|Subcutaneous delivery of insulin using Disetronic Accu-Chek Rapid D infusion set|bolus delivery of insulin given subcutaneously prior to standardized meal
16235397|NCT01120431|Other|Oral rehydration fluid|Oral electrolyte solution or other clinically acceptable oral rehydration fluid, 5 to 10 mL of offered with encouragement every 5 to 10 minutes
16235398|NCT01120431|Drug|Isotonic hydration fluid and recombinant human hyaluronidase|Single subcutaneous dose of 150 U recombinant human hyaluronidase, followed by infusion pump-delivered subcutaneous isotonic hydration fluid
16235399|NCT01120418|Drug|Besifloxacin Ophthalmic Suspension 0.6%|administered 3 times a day for 5 days to one eye.
16235400|NCT01120405|Drug|Xenon|
16235401|NCT01120405|Drug|Sevoflurane|
16235402|NCT01120392|Other|treatment with Nintendo wii.|Participants Will receive treatment with Nintendo Wii over one months. These Patients Will Be subjected to mobilization of stem and stretching. Then Will Be Submitted to Nintendo wii games. Will Be Submitted This group three times a week to a treatment protocol with boxing exercises with wii sports and wii fit
16235403|NCT01120392|Other|Physical therapy conventional.|Conventional exercises used with the same goals for the group with wii
16235404|NCT01120379|Device|XIENCE V® EECSS|Single-arm study designed to evaluate XIENCE V® EECSS continued safety and effectiveness during commercial use in real world settings.
16235405|NCT01120366|Drug|Tocilizumab plus methotrexate|Tocilizumab 8mg/kg 4weeks (i.v.) plus methotrexate up to 52weeks.The dosage of MTX will be fixed at least 24 weeks from the start of the study.
16235406|NCT01120366|Drug|Tocilizumab|tocilizumab 8mg/kg/4weeks (i.v.) up to 52weeks.
16235407|NCT01120340|Drug|mesalamine|mesalamine: 1.6 g/die for ten days/month until 24 months
16235408|NCT01120340|Other|placebo|2 pills/day for ten days/month until 24 months
16235409|NCT01120327|Drug|Placebo|Placebo
16235410|NCT01120327|Drug|Amlodipine|Amlodipine
16235411|NCT01120314|Drug|OTAMIXABAN (XRP0673)|"Form: solution for injection
~Route: intravenous"
16235412|NCT01120301|Device|NeuroThera® Laser System|Transcranial delivery of laser therapy or sham (no laser therapy) to the scalp
16235413|NCT01120288|Drug|EZN-2968|
16235414|NCT01120275|Drug|gamma-secretase/Notch signalling pathway inhibitor RO4929097|Given PO
16235415|NCT01120275|Other|laboratory biomarker analysis|Correlative studies
16235416|NCT01120262|Genetic|gene expression analysis|
16235417|NCT01120262|Genetic|polymorphism analysis|
16235418|NCT01120262|Other|laboratory biomarker analysis|
16235419|NCT01120249|Drug|everolimus|Given orally
16235420|NCT01120249|Other|placebo|Given orally
16235421|NCT01120236|Drug|Bicalutamide|Given PO
16235422|NCT01120236|Biological|Cixutumumab|Given IV
16235423|NCT01120236|Drug|Goserelin Acetate|Given SC
16235424|NCT01120236|Other|Laboratory Biomarker Analysis|Correlative studies
16235425|NCT01120236|Drug|Leuprolide Acetate|Given IM
16235426|NCT01120236|Other|Pharmacological Study|Correlative studies
16235427|NCT01120223|Drug|LEO 80185 (Xamiol® gel/Taclonex® Scalp topical suspension)|Once daily application
16235428|NCT01120210|Drug|JNJ-39588146 5 ng/kg/min|1-hour infusion of JNJ-39588146 5 ng/kg/min on Day 1
16235854|NCT01117441|Drug|etoposide|see detailed protocol description
16235429|NCT01120210|Drug|JNJ-39588146 15 ng/kg/min|1-hour infusion of JNJ-39588146 15 ng/kg/min on Day 1
16235430|NCT01120210|Drug|JNJ-39588146 30 ng/kg/min|1-hour infusion of JNJ-39588146 30 ng/kg/min on Day 1
16235431|NCT01120210|Drug|Placebo|1-hour infusion of matching placebo on Day 1
16235432|NCT01120210|Drug|JNJ-39588146 5, 15, or 30 ng/kg/min|18-hour infusion of JNJ-39588146 or matching placebo on Day 1 immediately folllowing the 3-hour infusion at a dose equal to the maximum dose tolerated by that patient during the 3-hour infusion in Part 1 of the study.
16235433|NCT01120197|Other|Exercise group|Weekly exercises
16235434|NCT01120197|Other|Control Group|No Intervention, control group only
16235435|NCT01120184|Drug|docetaxel|75 mg/m2 or 100 mg/m2 intravenously every 3 weeks for a minimum of 6 cycles.
16235436|NCT01120184|Drug|paclitaxel|80 mg/m2 intravenously weekly for a minimum of 18 weeks
16235437|NCT01120184|Drug|pertuzumab|840 mg intravenously on day 1 of cycle 1 followed by 420 mg intravenously every 3 weeks in subsequent cycles
16235438|NCT01120184|Drug|pertuzumab-placebo|840 mg intravenously on day 1 of cycle 1 followed by 420 mg intravenously every 3 weeks in subsequent cycles
16235439|NCT01120184|Drug|trastuzumab [Herceptin]|trastuzumab [Herceptin] doses when administered with docetaxel: 8 mg/kg intravenously on cycle 1 followed by 6 mg/kg every 3 weeks in subsequent cycles or trastuzumab (Herceptin) doses when administered with paclitaxel: 4 mg/kg intravenously on day 1 of cycle 1 followed by 2 mg/kg weekly starting on day 8 of cycle 1.
16235440|NCT01120184|Drug|trastuzumab emtansine|3.6 mg/kg intravenously every 3 weeks
16235441|NCT01120171|Drug|Cyclophosphamide|"Cyclophosphamide (IV) 600 mg/m2 on day 1. Treatment repeats every 21 days. Primary prophylaxis with pegfilgrastim (6 mg) administered 24 hours after chemotherapy.
~Therapy will continue until maximum response,or unacceptable toxicity."
16235442|NCT01120171|Drug|Liposomal-encapsulated doxorubicin|"Liposomal-encapsulated doxorubicin (IV) 50 mg/m2 on day 1. Treatment repeats every 21 days.
~Primary prophylaxis with pegfilgrastim (6 mg) administered 24 hours after chemotherapy.
~Therapy will continue until maximum response or unacceptable toxicity."
16235443|NCT01120158|Drug|Bevacizumab|Bevacizumab (IV) 10 mg/kg on day 1 and day 15. Treatment repeats every 28 days. Therapy will continue until maximum response, disease progression or unacceptable toxicity.
16235444|NCT01120158|Drug|Paclitaxel|Paclitaxel (IV) 120 mg/m2,on day 1 and day 15. Treatment repeats every 28 days Therapy will continue until maximum response, disease progression or unacceptable toxicity.
16235445|NCT01120132|Drug|CsA high dose|Solution of Cyclosporine (high dose) administered during 28 days
16235446|NCT01120132|Drug|CsA low dose|Solution of Cyclosporine (low dose) administered during 28 days
16235447|NCT01120132|Drug|PA|Suspension of Prednisolone Acetate administered during 28 days
16235448|NCT01120132|Drug|Placebo|Placebo solution administered during 28 days
16235449|NCT01120119|Drug|Calcitriol|
16235450|NCT01120106|Drug|levosimendan|patients enrolled in this group will receive a levosimendan continuous infusion at a rate of 0.1 mcg/kg/min
16235451|NCT01120106|Drug|placebo|saline continuous infusion
16235452|NCT01120093|Drug|Aclidinium bromide 100 μg bid|Aclidinium bromide 100 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days
16235453|NCT01120093|Drug|Aclidinium bromide 200 μg bid|Aclidinium bromide 200 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days
16235454|NCT01120093|Drug|Aclidininum bromide 400 μg bid|Aclidinium bromide 400 μg twice-daily via inhalation by Eklira Genuair® inhaler: 1 puff in the morning and evening for 7 days
16235455|NCT01120093|Drug|Placebo|Placebo via inhalation in the morning and evening for 7 days
16235456|NCT01120093|Drug|Formoterol 12 μg bid|Formoterol 12 μg twice-daily via inhalation by Aerolizer® dry powder inhaler: 1 puff in the morning and evening for 7 days
16235457|NCT01120080|Behavioral|Practical Counseling|To ensure that treatment effects are not due to the longer counseling intervention and additional alcohol intervention workbook in the Alcohol Intervention plus Standard Care condition, we will provide additional smoking cessation advice that will not be specific to alcohol use and an additional smoking cessation workbook for participants in the Practical Counseling plus Standard Care condition. Consistent with the Clinical Practice Guideline Update, we will include 5 minutes of practical counseling, which has been shown empirically to be effective in improving rates of smoking cessation.
16235458|NCT01120080|Behavioral|Alcohol Intervention Counseling|The Alcohol Intervention counseling protocol will be adapted from Dr. Ockene's brief alcohol intervention protocol and Dr. Kahler's brief alcohol intervention for smokers: Feedback and discussion on the relationship between drinking and smoking, and on the potential effects of alcohol consumption on smoking cessation; an emphasis on personal Responsibility for choosing to change one's behavior; Advice to avoid or minimize drinking during the smoking cessation process; a Menu of options for carrying out a change strategy; use of Empathy by the clinician; and encouragement of Self-efficacy (i.e., confidence) for successful change.
16235459|NCT01120067|Behavioral|Intensive Treatment|Participants randomized to the Intensive Treatment condition will attend 6 bi-weekly outpatient therapy sessions conducted in an individual format of 90 minutes in duration.
16235460|NCT01120067|Behavioral|Treatment as Usual|Treatment as Usual.
16235461|NCT01120041|Behavioral|motivational interviewing counseling|Motivational interviewing counseling given during the prenatal and postpartum phases
16235462|NCT01120041|Behavioral|motivational interviewing counseling|Motivational interviewing counseling given during the prenatal phase with traditional health education given during the postpartum phase
16235463|NCT01120041|Behavioral|motivational interviewing counseling|Traditional health education given during the prenatal phase with motivational interviewing counseling given during the postpartum phase
16235464|NCT01120041|Behavioral|health education|Traditional health education given during the prenatal phase and the postpartum phase
16235465|NCT01120028|Drug|Alemtuzumab|Alemtuzumab 30 mg intravenously or subcutaneously, two doses 24 hours apart
16235466|NCT01120028|Drug|Basiliximab|20 mg intravenously, two doses 96 hours apart
16235467|NCT01120028|Drug|Sirolimus|Sirolimus: target trough levels 6-12 ng/mL for first 6-months after maintenance therapy randomization, then 5-10 ng/mL
16235468|NCT01120028|Drug|Tacrolimus|Tacrolimus: target trough levels 5-7 ng/mL after maintenance therapy randomization.
16235855|NCT01117441|Drug|ifosfamide|see detailed protocol description
16235469|NCT01120015|Drug|diacerein|Diclofenac sodium 75mg sustained release tablet once daily was given to both groups for 3 months. Capsule diacerein 50mg in study group and matched placebo in control group were given once daily for first month and twice daily for next two months with the main meals.
16235470|NCT01120002|Drug|Tamibarotene|Two Tamibarotene 2 mg or placebo tablet per day, once daily.
16235471|NCT01120002|Drug|Placebo|Two Tamibarotene 2 mg or placebo tablet per day, once daily.
16235472|NCT01119989|Dietary Supplement|Fructose+maltodextrin placebo|
16235473|NCT01119989|Dietary Supplement|amino-acid + fructose|
16235474|NCT01119976|Behavioral|Reduced calorie diet and exercise plan|Participants will receive written diet and exercise instructions to follow for the duration of the study.
16235475|NCT01119976|Behavioral|Different reduced calorie diet and exercise plan|Participants will receive written diet and exercise instructions to follow for the duration of the study.
16235476|NCT01119963|Drug|17-alpha-hydroxy-progesterone caproate, Makena®|Intramuscular (IM) injection of 17P,Makena® (250mg) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first.
16235477|NCT01119963|Drug|Castor Oil (Placebo)|IM injections of Placebo (castor oil) beginning as early as 23w0d administered weekly until 34w0d, documented fetal lung maturity at 32w0d - 33w6d, or delivery which ever comes first.
16235478|NCT01119950|Drug|NVA237 12.5 µg once daily|NVA237 12.5 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2.
16235479|NCT01119950|Drug|NVA237 25.0 µg once daily|NVA237 25.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2.
16235480|NCT01119950|Drug|NVA237 12.5 µg twice daily|NVA237 12.5 µg via dry powder inhaler twice daily for 28 days during either period 1 or during period 2.
16235481|NCT01119950|Drug|NVA237 50.0 µg once daily|NVA237 50.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2.
16235482|NCT01119950|Drug|NVA237 25.0 µg twice daily|NVA237 25.0 µg via dry powder inhaler twice daily for 28 days during either period 1 or during period 2.
16235483|NCT01119950|Drug|NVA237 100.0 µg once daily|NVA237 100.0 µg via dry powder inhaler once daily for 28 days during either period 1 or during period 2.
16235484|NCT01119950|Drug|NVA237 50.0 µg twice daily|NVA237 50.0 µg via dry powder inhaler twice daily for 28 days during either period 1 or during period 2.
16235485|NCT01119950|Drug|Placebo to NVA237 once daily|Placebo to NVA237 via dry powder inhaler once daily for 28 days during either period 1 or during period 2.
16235486|NCT01119937|Drug|NVA237|50µg capsules for inhalation, delivered via a single dose dry powder inhaler (Concept 1®)
16235487|NCT01119937|Drug|Tiotropium|18µg capsules for inhalation, delivered via HandiHaler®
16235488|NCT01119924|Drug|Smilon®|Smilon® tablet 15mg mg/day or placebo, once a day on the first week, and then for 7 consecutive weeks
16235489|NCT01119924|Drug|Placebo|Smilon® tablet 15mg mg/day or placebo, once a day on the first week, and then for 7 consecutive weeks
16235490|NCT01119911|Other|Blood sampling from peripheral venous catheter.|Venipuncture is performed on the opposite limb of the peripheral venous catheter. Within 3 minutes, a second sample is taken from existing peripheral venous catheter used for fluid administration. Intravenous fluids are then stopped for 30 seconds and a tourniquet applied proximal to the device for another 30 seconds. A 2-mL syringe is attached and 0.5 mL of blood aspirated and discarded. Thereafter, 2 mL blood is slowly drawn during about 15 seconds, into a different 2-mL syringe, to allow a gentle pumping action that may reduce vacuum in the syringe and thus hemolysis rates. Afterwards, the intravenous device is flushed with 2 mL normal saline and infusion restarted.
16235491|NCT01119898|Drug|PENNSAID Gel|2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
16235492|NCT01119898|Drug|Vehicle|2 mL applied to the front, back and sides of the knee twice a day (morning and night) for 4 weeks
16235493|NCT01119885|Drug|fentanyl matrix|Knee osteoarthritis, starting with 12mcg/h (flexible dose)
16235494|NCT01119885|Drug|fentanyl matrix|Hip osteoarthritis, starting with 12mcg/h (flexible dose)
16235495|NCT01119872|Other|Positive End-expiratory Pressure (PEEP)|"All patients were ventilated during 24 hours with low tidal volume (6-8 milliliters/kilogram of predicted body weight), plateau airway pressure limited at 35 centimeters of water, initial ventilator rate of 30 breaths/minute adjusted to maintain a pH goal of 7.30 to 7.45 to a maximum of 35 breaths/minute, fraction of inspired oxygen ensuring arterial oxygen saturation 88-95% or arterial partial pressure of oxygen of 55-80 mmHg.
~Level of Positive End-Expiratory Pressure (PEEP) applied according the 2 arms of treatment."
16235496|NCT01119859|Drug|Tocilizumab|The maximum dose was 800 mg for patients weighing more than 100 kg. Tocilizumab was infused into an arm vein over a 1-hour period.
16235497|NCT01119859|Drug|Adalimumab|
16235498|NCT01119859|Drug|Placebo to tocilizumab|
16235499|NCT01119859|Drug|Placebo to adalimumab|
16235500|NCT01119846|Drug|GSK1292263|GSK1292263 is an immediate-release round, white, film-coated tablet provided in 3 strengths, 25mg, 75mg and 200mg being developed for the treatment of type 2 diabetes.
16235501|NCT01119846|Drug|GSK1292263 matching placebo|Matching placebo to active drug GSK1292263
16235502|NCT01119846|Drug|Sitagliptin|"Sitagliptin (Januvia) 100mg tablets are beige, round, film-coated tablets with 277 on one side."
16235503|NCT01119833|Drug|GMI-1070|Intravenous GMI-1070 given twice a day during hospital stay for sickle cell pain crisis
16235504|NCT01119833|Drug|Placebo|Intravenous Placebo given twice a day during hospital stay for sickle cell pain crisis
16235505|NCT01119820|Other|Tissue Donation|Females over 18 who are scheduled to undergo elective surgery will have discarded tissue collected.
16235506|NCT01119807|Device|Intravenous access during OHCA|First attempt will be a peripheral IV in the AC. If this fails, second attempt will be a tibial IO, followed by a humeral IO when indicated.
16235507|NCT01119807|Device|Humeral IO insertion|First attempt will be a humeral IO. Second attempt should occur at the tibia if the first humeral IO fails. Subsequent attempts will be for a peripheral IV or additional IOs as determined by the paramedic.
16235508|NCT01119807|Device|TIbial IO insertion|First attempt will be a tibial IO. Second attempt should occur on the opposite tibia if the first IO fails. Subsequent attempts will be for a humeral IO or peripheral IV as selected by the paramedic.
16235856|NCT01117441|Drug|mercaptopurine|see detailed protocol description
16235509|NCT01119794|Drug|Ofatumumab and Bortezomib|Ofatumumab 1000 mg IV Cycle 1 on day 1, 8, 15 and 22 Bortezomib 1.6 mg/m2 IV Ofatumumab 1000 mg IV on day 1 maintenance phase Patients will remain until progression
16235510|NCT01119781|Drug|BIIB017(peginterferon beta-1a)|peginterferon beta-1a administered by a single subcutaneous (SC) injection using a pre-filled syringe on Day 1 at a dose of either 63 or 125 mcg depending on subpopulation assignment reflecting whether a healthy volunteer or level of renal impairment.
16235511|NCT01119768|Drug|Esomeprazole|20mg Esomeprazole once daily, 8 weeks and 24 weeks on-demand treatment
16235512|NCT01119768|Drug|Esomeprazole|20mg Esomeprazole once daily, 2 weeks and 24 weeks follow up
16235513|NCT01119742|Drug|Butenafine Hydrochloride 1%|Twice daily application for 7 days
16235514|NCT01119742|Drug|Butenafine Hydrochloride 1% B|Twice daily application for 7 days
16235515|NCT01119742|Drug|Butenafine Hydrochloride 1%|Twice daily application for 7 days
16235516|NCT01119742|Drug|Vehicle A|Twice daily application for 7 days
16235517|NCT01119742|Drug|Vehicle B|Twice daily application for 7 days
16235518|NCT01119703|Biological|Tetanus & Diphtheria booster vaccine (Td)|Tetanus & Diphtheria booster vaccine (Td), single intramuscular dose
16235519|NCT01119703|Biological|TwinrixTM [Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine]|TwinrixTM [Hepatitis A Inactivated & Hepatitis B (Recombinant) Vaccine], intramuscular, two doses of standard three dose regimen (opposite arms)
16235520|NCT01119703|Biological|Dukoral® Traveler's Diarrhea Vaccine (WC/rBS)|Dukoral® Traveler's Diarrhea Vaccine, recombinant Cholera toxin B subunit (WC/rBS), standard two oral doses per treatment regimen
16235521|NCT01119690|Dietary Supplement|Cold-pressed turnip rapeseed oil (CTPRO)|"In the dietary period of 6 to 8 weeks: CTPRO 37 ml/day.
~In the 5-hour oral glucose and fat tolerance test: glucose and CTPRO."
16235522|NCT01119690|Dietary Supplement|milk fat|"In dietary period of 6 to 8 weeks: 37.5 grams of butter.
~In the 5-hour oral glucose and fat tolerance test: glucose and cream"
16235523|NCT01119677|Drug|Avonex|Group 1 subjects will receive weekly Avonex 30 mcg (full dose) IM injections from Week 1 to Week 8. Group 2 subjects will titrate in quarter dose increments every week up to a full dose of Avonex over a 3 week period from Week 1 to Week 3 and then continue on full dose from Week 4 to Week 8. Group 3 subjects will titrate in quarter dose increments every 2 weeks up to a full dose of Avonex over a 6 week period from Week 1 to Week 6 and continue on full dose from Week 7 to Week 8
16235524|NCT01119664|Drug|SCH 721015|
16235525|NCT01119651|Drug|Tazarotene (Patch application in Challenge Phase)|There are 2 phases in this study. The induction phase will include 6 days of patch application to the subject's back. Patches will be removed daily and irradiated. Patch applications will be placed on the same sites, unless a strong reaction is observed. The induction phase will be followed by a rest period followed by the Challenge Phase which consists of a 24-hr application of 3 sets of 3 patches (Set C, Set D, and Set E) applied to naïve sites on the subject's back. Each set of patches will consist of a tazarotene foam patch, a vehicle foam patch, and a blank patch. After 24 hrs, Set D patch sites will be evaluated and irradiated with UVA/UVB light. Set C patch sites will be evaluated and irradiated with UVA, UVB light and visible light. Set E patch sites will be evaluated & will serve as nonirradiated controls. Patch sites will be evaluated 1 hr after patch removal and during follow up visits at 24 hrs, 48 hrs, and 72 hrs after removal of the final patch in Set E.
16235526|NCT01119638|Drug|Escitalopram|Patients in the escitalopram group will receive 5 mgs/d for the first week and than 10 mgs/d till completion.
16235527|NCT01119638|Drug|Risperidone|Patients in the risperidone group will receive 0.5 mgs/d for the first week and than 1.0 mg/d till completion.
16235528|NCT01119625|Biological|Pneumococcal vaccine GSK1024850A|Intramuscular injection, one dose
16235529|NCT01119625|Biological|Infanrix-IPV/Hib|Intramuscular injection, one dose
16235530|NCT01119612|Dietary Supplement|Iron|Daily oral dose of 60 mg from enrollment until delivery
16235531|NCT01119612|Other|Placebo|Daily oral dose from enrollment until delivery
16235532|NCT01119599|Radiation|3-Dimensional Conformal Radiation Therapy|Undergo 3-D conformal radiation therapy
16235533|NCT01119599|Drug|Gamma-Secretase Inhibitor RO4929097|Given PO
16235534|NCT01119599|Radiation|Intensity-Modulated Radiation Therapy|Undergo IMRT
16235535|NCT01119599|Other|Laboratory Biomarker Analysis|Correlative studies
16235536|NCT01119599|Other|Pharmacological Study|Correlative studies
16235537|NCT01119599|Drug|Temozolomide|Given PO
16235538|NCT01119599|Procedure|Therapeutic Conventional Surgery|Undergo surgery
16235539|NCT01119586|Genetic|DNA analysis|
16235540|NCT01119586|Genetic|genetic linkage analysis|
16235541|NCT01119586|Genetic|microarray analysis|
16235542|NCT01119586|Genetic|nucleic acid sequencing|
16235543|NCT01119586|Genetic|polymerase chain reaction|
16235544|NCT01119586|Genetic|polymorphism analysis|
16235545|NCT01119586|Other|laboratory biomarker analysis|
16235546|NCT01119573|Genetic|RNA analysis|
16235547|NCT01119573|Genetic|microarray analysis|
16235548|NCT01119573|Genetic|reverse transcriptase-polymerase chain reaction|
16235549|NCT01119573|Other|laboratory biomarker analysis|
16235550|NCT01119560|Other|Cytology Specimen Collection Procedure|Correlative studies
16235551|NCT01119560|Other|Laboratory Biomarker Analysis|Correlative studies
16235552|NCT01119560|Other|Questionnaire Administration|Ancillary studies
16235553|NCT01119547|Other|Exercise in a group|The patient do their individual exercise program in a group.
16235554|NCT01119547|Other|Home exercise|The patient exercise their individual program at home during 6 v.
16235555|NCT01119534|Drug|Guaiacol, eucalyptol, menthol and camphor suppository|2 times per day
16235556|NCT01119534|Drug|guaiacol suppository|2 times per day
16235557|NCT01119534|Drug|Guaifenesin syrup|4.19 mL - 4 in 4 hours
16235558|NCT01119521|Biological|BCG strain Danish|Intradermal Bacillus Calmette-Guerin (BCG) live-attenuated vaccine prepared using the Danish 1331 BCG substrain; adult dose contains 2 to 8 x 10^5 colony forming units (CFU) BCG.
16235559|NCT01119521|Drug|Isoniazid|United States Pharmacopeia 100 mg or 300 mg oral tablets [5 mg/kilogram/day (rounded up to nearest 100 mg; maximum dose 300 mg/day)].
16235616|NCT01119183|Behavioral|No intervention for this arm|No educational literature will be offered to this group
16235560|NCT01119508|Drug|Ipilimumab|Induction Phase: 10 mg/kg by vein (IV) over approximately 90 minutes on Day 1 only repeated every 3 weeks until 4 courses of therapy are given over 3 months. For the Maintenance Phase, dose repeated every 12 weeks.
16235561|NCT01119508|Drug|Temozolomide|Induction Phase, 200 mg/m^2 by mouth (PO) on Days 1 to 4, repeated every 3 weeks until 4 courses of therapy are given over 3 months. For the Maintenance Phase, dose delivered on Days 1 to 5, repeated every 4 weeks.
16235562|NCT01119482|Biological|MenAfriVac™|Children, adolescents and adults aged 1 to 29 years old will receive a single intramuscular injection of the meningococcal serogroup A conjugate vaccine .
16235563|NCT01119469|Behavioral|Psychotherapy (CT or ET)|weekly 50-minute sessions for 12 weeks
16235564|NCT01119456|Biological|IMC-RON8|"5 milligrams per kilogram (mg/kg) intravenously (IV)
~Once a week for each 4-week treatment cycle, for a total of four doses per cycle. The initial 4-week treatment cycle will be followed by a 2-week observation period.
~Cohort 1"
16235565|NCT01119456|Biological|IMC-RON8|"10 mg/kg IV
~Once a week for each 4-week treatment cycle, for a total of four doses per cycle. The initial 4-week treatment cycle will be followed by a 2-week observation period.
~Cohort 2"
16235566|NCT01119456|Biological|IMC-RON8|"15 mg/kg IV
~Once a week for each 4-week treatment cycle, for a total of four doses per cycle. The initial 4-week treatment cycle will be followed by a 2-week observation period.
~Cohort 3"
16235567|NCT01119456|Biological|IMC-RON8|"15 mg/kg IV
~Once every 2 weeks for each 4-week treatment cycle, for a total of two doses per cycle.
~Cohort 4"
16235568|NCT01119456|Biological|IMC-RON8|"20 mg/kg IV
~Once every 2 weeks for each 4-week treatment cycle, for a total of two doses per cycle.
~Cohort 5"
16235569|NCT01119456|Biological|IMC-RON8|"25 or 30 mg/kg IV
~Once every 2 weeks for each 4-week treatment cycle, for a total of two doses per cycle.
~Cohort 6"
16235570|NCT01119456|Biological|IMC-RON8|"30, 35, or 40 mg/kg IV
~Once every 2 weeks for each 4-week treatment cycle, for a total of two doses per cycle.
~Cohort 7"
16235571|NCT01119456|Biological|IMC-RON8|"20 or 25 mg/kg IV
~Once every week for each 4-week treatment cycle, for a total of four doses per cycle.
~Cohort 8"
16235572|NCT01119443|Drug|PPX ER|PPX ER 0.375mg - 1.5mg for 32 days totally
16235573|NCT01119443|Drug|PPX ER|PPX ER 0.375mg - 1.5mg for 32 days totally
16235574|NCT01119430|Drug|DU125530|20mg/twice a day
16235575|NCT01119430|Drug|Placebo|Similar pill as active comparator twice a day
16235576|NCT01119417|Drug|BQ123|Low dose day: 25 nmol/min, single IV infusion for 15 min.
16235577|NCT01119417|Drug|BQ123|Low dose day: 50 nmol/min, single IV infusion for 15 min
16235578|NCT01119417|Drug|Bq123|High dose day: 100 nmol/min, single IV infusion for 15 min.
16235579|NCT01119417|Drug|BQ123|High dose day: 300 nmol/min, single IV infusion for 15 min.
16235580|NCT01119417|Drug|Saline|2-3 IV saline infusions for 15 min each.
16235581|NCT01119391|Behavioral|There was no intervention; this was a survey only study|There was no intervention; this was a survey only study
16235582|NCT01119378|Other|Dual isotope technique|Dual isotope technique using stable isotopes
16235583|NCT01119365|Other|Bright light|Bright (1000 lux) light
16235584|NCT01119352|Drug|AZD7687|Oral suspension, once daily. Starting dose of 1mg and with up to 4 dose escalations. Totally 8 doses.
16235585|NCT01119352|Drug|Placebo|Oral suspension, once daily. Totally 8 doses
16235586|NCT01119339|Drug|LAS 41004|LAS 41004 dosage 1, once daily
16235587|NCT01119339|Drug|LAS 41004|LAS 41004 dosage 2, once daily
16235588|NCT01119339|Drug|LAS 41004|LAS 41004 dosage 3, once daily
16235589|NCT01119339|Drug|LAS 41004|LAS 41004 dosage 4, once daily
16235590|NCT01119339|Drug|LAS 41004|LAS 41004 , dosage 5, once daily
16235591|NCT01119339|Drug|LAS 41004 dosage 6|LAS 41004, dosage 6, once daily
16235592|NCT01119339|Drug|Placebo|Placebo, once daily
16235593|NCT01119339|Drug|Reference|Reference, once daily
16235594|NCT01119326|Procedure|Autologous Fat Transfer|one site will be treated with AFT For placebo treated (control) sites, an equal number of empty cannula passes will be administered using a similar technique described for the AFT.
16235595|NCT01119313|Drug|LAS 41002|LAS 41002, once daily
16235596|NCT01119313|Drug|Active|Active, once daily
16235597|NCT01119300|Other|Genotype-guided dosing algorithm|Loading and monitoring dose according to genotype-guided dosing algorithm
16235598|NCT01119300|Other|Standard care|Standard care
16235599|NCT01119287|Drug|Dexamethasone 0.1% ophthalmic suspension|Maxidex
16235600|NCT01119287|Drug|Olopatadine hydrochloride 0.1% ophthalmic solution|Patanol
16235601|NCT01119287|Other|Inactive ingredients, used as placebo|Tears Naturale II
16235602|NCT01119274|Other|Genotype-guided dosing algorithm|Loading and monitoring dose according to genotype-guided dosing algorithm
16235603|NCT01119274|Other|Non-genotype-guided dosing algorithm|Loading and monitoring dose according to non-genotype-guided dosing algorithm
16235604|NCT01119261|Other|Genotype-guided dosing algorithm|Loading and monitoring dose according to genotype-guided dosing algorithm
16235605|NCT01119261|Other|Non-genotype-guided dosing algorithm|Loading and monitoring dose according to non-genotype-guided dosing algorithm
16235606|NCT01119248|Other|axillary temperature before MRI and after the MRI|observation of body temperature changes with axillary temperature measurement with MRI compatible device
16235607|NCT01119235|Drug|PF-04531083|Dosed as a tablet in 100mg strengths. Dosage in the first cohort will be 300mg twice daily for 3 days followed by 200mg twice daily for 11 days
16235608|NCT01119235|Drug|PF-04531083|Dosed as a tablet in 100mg strengths. Dosage in this optional second cohort will be optimised based on the data arising from Cohort 1
16235609|NCT01119222|Drug|Gabapentin|Capsule, single 1200mg dose
16235610|NCT01119222|Drug|Diphenhydramine|Tablet, single 50mg dose
16235611|NCT01119222|Drug|Morphine|IV, single 10mg dose
16235612|NCT01119222|Drug|Placebo|Placebo formulations (Capsule, tablet, IV to match the active treatments and to be administered in a double-dummy fashion).
16235613|NCT01119209|Drug|Ropivacaine|Approved by the Danish Medicines Agency
16235614|NCT01119209|Drug|Saline|Approved by the Danish Medicines Agency
16235615|NCT01119196|Other|Icodextrin dialysate|use of alternate SOC dialysate
16235857|NCT01117441|Drug|methotrexate|see detailed protocol description
16235617|NCT01119183|Behavioral|ACOG education pamphlet on preeclampsia|The ACOG pamphlet on preeclampsia will be offered to this group
16235618|NCT01119183|Behavioral|Preeclampsia education tool|The newly created preeclampsia educational tool will be offered to this group
16235619|NCT01119170|Other|Starter formula|standard starter formula given from birth to 6 months of age
16235620|NCT01119170|Other|starter formula with D-lactate producing probiotics|starter formula containing probiotics given from birth to 6 months of age
16235621|NCT01119157|Biological|influenza vaccine|whole virus influenza vaccine adjuvanted with aluminium phosphate, 3 x 15 μg HA / 0.5 ml, for i.m. administration subunit influenza vaccine 3 x 15 μg HA / 0.5 ml, for i.m. administration split influenza vaccine 3 x 15 μg HA / 0.5 ml, for i.m. administration
16235622|NCT01119144|Device|Polycaprolactone / Tri-Calcium Phosphate|Orbital implant for reconstruction of the orbital walls
16235623|NCT01119144|Device|Titanium Mesh|Titanium mesh for comparison to Polycaprolactone / Tri-Calcium Phosphate (PCL / TCP) mesh
16235624|NCT01119131|Drug|Vitamin D3|Vitamin D3 at 10,000 IU a day
16235625|NCT01119131|Dietary Supplement|calcium|1000mg calcium daily
16235626|NCT01119131|Other|Placebo|A placebo pill with similar appearance to the vitamin D3 will be given to those in the placebo arm
16235627|NCT01119118|Drug|ZD4054|All patients will be treated with ZD4054 at 10 mg PO daily, repeated in four week cycles (1 cycle = 28 days). All patients will initially undergo NaF and FDG PET/CT and MRI imaging at baseline (scan#1), and then again after 4 weeks (scan#2) of ZD4054 exposure. Subsequently, ZD4054 will be held for 2 weeks followed by the final NaF and FDG-PET/CT and MRI acquisition (scan#3). After the final PET/MRI is obtained, patients will resume ZD4054 and be assessed for safety prior to each new cycle of therapy. Standard disease evaluation assessments will be conducted after cycle#3, and repeated after every third cycle (sooner if clinically indicated). Therapy will continue until radiographical/clinical disease progression or unacceptable toxicity
16235628|NCT01119105|Drug|BC-3781|BC-3781 dose 100mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
16235629|NCT01119105|Drug|BC-3781|BC-3781 dose 150mg is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
16235630|NCT01119105|Drug|Vancomycin|Vancomycin is administered as i.v. infusion every 12 h for 5 to 14 days depending on the clinical response.
16235631|NCT01119092|Other|"Sham (laying of hands) intervention"|The clinician will place his/her hands in a position to perform the AP joint mobilizations but will not actually perform them. The sham treatment will be performed 3 times and each will last a period of 60 seconds with a one minute rest in between.
16235632|NCT01119092|Other|Grade IV AP joint mobilizations|3 60-second treatments of Grade IV AP joint mobilizations of the talus during each treatment session, with a one minute rest in between each treatment.
16235633|NCT01119079|Other|Normal Saline|10ml Normal Saline instilled in the epidural space
16235634|NCT01119079|Procedure|Administration of epidural anesthesia for labor|Standard procedure
16235635|NCT01119066|Radiation|total body irradiation|dose of 1375-1500 cGy
16235636|NCT01119066|Drug|Thiotepa|5 mg/kg/day x 2 or 10 mg/kg/day x 1
16235637|NCT01119066|Drug|Cyclophosphamide|60 mg/ kg/day x 2 (or fludarabine 25mg/m2 x 5 if cyclophosphamide is contraindicated).
16235638|NCT01119066|Drug|Busulfan|0.8 mg/kg every 6 hours x 10 or 12 doses (depending on disease) with dose modified according to pharmacokinetics
16235639|NCT01119066|Drug|Melphalan|70mg/m2/day x 2
16235640|NCT01119066|Drug|Fludarabine|25mg/m2/ day x 5
16235641|NCT01119066|Drug|Clofarabine|20mg/m2/ day x 5 (or, for children <18 years of age, 30mg/m2/day x 5 if deemed suitable and with PI approval)
16235642|NCT01119066|Procedure|(CliniMACS) T-cell depleted PBSC Transplant|
16235643|NCT01119053|Device|VNS Pulse Model 102|Individual dosage within the realm of 0,25 mA - 3,5 mA. Uninterrupted stimulation of 24 h.
16235644|NCT01119053|Device|VNS Pulse Model 102|Within this branch, study participants obtain the VNS therapy after a defined space of time of 12 weeks.
16235645|NCT01119040|Procedure|Natural Orifice Translumenal Endoscopic Surgery|"Natural Orifice Translumenal Endoscopic Surgery (NOTES) procedures involve transmural passage of flexible endoscopes introduced via a natural orifice whereby permitting access to the peritoneal cavity while avoiding skin incisions. No clear indication due to a number of physiologic, microbiologic, immunologic, and technical limitations. The concept of NOTES PEG Rescue in the setting of a dislodged naïve PEG tube may spare individual patients the physiologic stress of traditional surgery while concomitantly providing a natural segue to further study the NOTES platform in the human setting. PEG Rescue may represent a unique, practical, and empowering application of the burgeoning experience of natural orifice translumenal endoscopic surgery."
16235646|NCT01119014|Drug|Aripiprazole|pill, 2,5-20 mg/day, maximum 16 weeks
16235647|NCT01119014|Drug|Quetiapine|pill, 50-600mg/day, maximum 16 weeks
16235648|NCT01119001|Device|P300 Brain Computer Interface Keyboard|Subjects will wear an EEG cap for 1-4 hours (1-2 hours typical) per session and use the brain-computer interface to operate assistive technology. Subjects will be asked to participate in 3 sessions.
16235649|NCT01118988|Behavioral|Mentorship|Subjects in this condition receive 10 sessions over 8 weeks (2 sessions for the first 2 weeks, 1 session per week for the remaining 6 weeks) with a mentor presenting information on pain self-management and coping techniques, as well as discussing concerns and feelings with the subject receiving the intervention. Information is presented on slides via internet connected home computer. Mentor-mentee interaction is conducted via telephone on a conference call line with a doctoral level psychologist monitoring call for safety of all parties.
16235650|NCT01118975|Drug|Vorinostat|"300 mg 4 days on then 3 days off
~As defined in the protocol, the dose of vorinostat was increased to 400 mg 4 days on then 3 days off in the pilot phase because the adverse event threshold was not met. In the Phase II cohort, the dose of vorinistat was 400 mg 4 days on and 3 days off."
16235651|NCT01118975|Drug|Lapatinib|1,250 mg once daily
16235686|NCT01118624|Dietary Supplement|Folic Acid|"1.0-1.25 mg orally
~Administered daily for at least 7 days prior to first dose of pralatrexate, throughout the study and for at least 30 days after the last dose of pralatrexate."
16235687|NCT01118611|Drug|Aurora B/C kinase inhibitor GSK1070916A|
16235688|NCT01118611|Other|laboratory biomarker analysis|
16235689|NCT01118611|Other|pharmacological study|
16235690|NCT01118611|Procedure|diffusion-weighted magnetic resonance imaging + PET CT|
16235652|NCT01118962|Drug|Lacosamide|Lacosamide was supplied as 50 mg and 100 mg tablets. The starting Lacosamide dose was the same dose reached by a subject at the end of SP0961 (NCT01118949). At the beginning of SP0962, the dose may be maintained, or increased or decreased by 100 mg /day, as deemed clinically appropriate to optimize tolerability and seizure reduction. Dose increases should be no faster than 100 mg/ day per week up to a maximum of 800 mg/ day. Lacosamide was administered twice daily (approx. 12 hours apart, once in the morning and once in the evening) in 2 equally divided doses for up to a 56-week Treatment Phase. The Treatment Phase was followed by a 5-week End-of-Study Phase, during which subjects had to be tapered off Lacosamide at a recommended decrease rate of 200 mg/ day per week.
16235653|NCT01118949|Drug|Lacosamide|Lacosamide is supplied as 50 mg, 100 mg, 150 mg, and 200 mg tablets. Subjects will begin a Dose-Titration Phase of Lacosamide at 100 mg/day (50 mg bid, approx. 12 hours apart, once in the morning and once in the evening) for 1 week. Three (3) weekly increases will follow until the subject reaches a dosage of 200 mg/day, 300 mg/day, or 400 mg/day, as deemed clinically appropriate. The final titration will be followed by a 6-week Maintenance Phase. Subjects who complete the Maintenance Phase have the opportunity to enroll in an open-label extension study; those who do not enroll will begin a 3-week End-of-Study Phase when Lacosamide will be tapered off gradually at a recommended rate of 200 mg/day/week.
16235654|NCT01118936|Dietary Supplement|Magnesium supplement (magnesium hydroxide/ -oxide)|3 tablets of Mablet (360 mg per tablet) daily for 12 weeks Produced by: Gunnar Kjems APS
16235655|NCT01118936|Dietary Supplement|Placebo|3 tablets of placebo daily for 12 weeks
16235656|NCT01118923|Dietary Supplement|Magnesium supplement (magnesium hydroxide/ -oxide)|3 tablets of Mablet (360 mg per tablet) daily for 12 weeks Produced by: Gunnar Kjems APS
16235657|NCT01118923|Dietary Supplement|Placebo|3 placebo-tablets daily for 12 weeks
16235658|NCT01118910|Drug|Vusion|Vusion will be applied to areas of intertrigo
16235659|NCT01118897|Radiation|Tomotherapy|"Radiotherapy 57-60 Gy in 25 fraction to PTV boost (SIBV - simultaneous integrated Boost volume) (2.3-2.4Gy/Fr)
~Concurrent chemotherapy Weekly concurrent CT schedule: Inj Gemcitabine 300 mg/m2 weekly during RT.
~Surgery: All patients will be evaluated for surgery in the joint clinic by surgeons and other treating physicians at 6-8 weeks post CT-RT. PET CT Scan will be used as the imaging modality. Patients suitable for R0 resection will be planned for surgery. Inoperable patients will be treated with palliative chemotherapy."
16235660|NCT01118884|Drug|Promethazine|Syrup ,1 mg/kg, oral , 30 minutes before dental procedure , its duration is 4-6 hours
16235661|NCT01118871|Drug|Darunavir, Ritonavir, Truvada|Darunavir 800 mg daily Ritonavir 100 mg daily Tenofovir 245 mg daily Emtricitabine 200 mg daily
16235662|NCT01118871|Drug|Darunavir, Ritonavir and Etravirine|Darunavir 800 mg daily Ritonavir 100 mg daily Etravirine 400 mg once daily
16235663|NCT01118845|Drug|SyB L-0501|"The administration of SyB L-0501 at 120 mg/m^2/day by intravenous infusion on day 2 and 3 of each 21-day cycle with up to 6 cycles. Dose modifications are permitted from 2nd cycle according to dose reduction schedule.
~SyB L-0501 60 mg/m^2, 90 mg/m^2 or 120 mg/m^2/day on Day 2 and Day 3 will be followed by 18 days of observation."
16235664|NCT01118845|Drug|Rituximab|The administration of rituximab at 375 mg/m^2/day by intravenous infusion on day 1 of each 21-day cycle with up to 6 cycles. Dose modifications are not permitted.
16235665|NCT01118819|Biological|Clostridium novyi-NT spores|Phase 1 study: It will be an escalating dose design, with no intracohort escalation. The first cohort dose will begin at 1 X 10(5) spores/kg and will escalate by tripling through 5 cohorts up to 100 x 10(5) spores/kg.
16235666|NCT01118793|Drug|Clopidogrel|150 mg dosage of Clopidogrel for 7 to 10 days.
16235667|NCT01118780|Drug|Duloxetine|Administered by mouth, daily for 10 weeks
16235668|NCT01118780|Drug|Placebo|Administered by mouth, daily for 10 weeks
16235669|NCT01118767|Other|Cell phone intervention|Participant receives short text messages, including: antiretroviral reminders, clinic appointment reminders, and preventive/educational messages
16235670|NCT01118754|Drug|DE-101 ophthalmic suspension|Ophthalmic suspention; QID
16235671|NCT01118754|Drug|DE-101 ophthalmic suspension|Ophthalmic suspension; QID
16235672|NCT01118754|Drug|DE-101 ophthalmic suspension vehicle|ophthalmic suspension vehicle; QID
16235673|NCT01118741|Drug|Disulfiram|Cohort 1: 250mg PO daily for 28 days Cohort 2: 500mg PO daily for 28 days
16235674|NCT01118728|Drug|Sarilumab|"Pharmaceutical form: solution for injection
~Route of administration: subcutaneous"
16235675|NCT01118715|Device|Compression glove|A compression glove worn during recovery from distal radius fracture
16235676|NCT01118702|Drug|Ritalin-SR|3-20mg tablets, once
16235677|NCT01118702|Drug|Concerta|one 54mg tablet, once
16235678|NCT01118702|Drug|Novo-Methylphenidate ER-C|one 54mg tablet, once
16235679|NCT01118689|Drug|MLN0128|MLN0128 administered orally once daily for 28 days
16235680|NCT01118676|Drug|cilengitide, radiochemotherapy|"Cilengitide will be administered alone as continuous infusion two weeks before the radiochemotherapy and will then be continued during radiochemotherapy (standard radiotherapy of 66 Gy, 2 Gy per daily fraction, and cisplatin and vinorelbine based chemotherapy)as continuous infusion.
~The dose levels investigated will be applied to the continuous administration of cilengitide(a maximum of 4 dose levels : 12, 18, 27 et 40 mg /hour).
~After the end of concomitant radiochemotherapy, cilengitide will be administered i.v. at a dose of 2000 mg twice weekly until the end of chemotherapy."
16235681|NCT01118663|Drug|Acetadote EF (Ethylenediaminetetraacetic Acid (EDTA) - Free)|Acetadote EF (Ethylenediaminetetraacetic Acid (EDTA) - Free) {new formulation} 200 mg/kg in 1000 ml diluent over 4 hours; then 100 mg/kg in 1000 ml diluent over 16 hours
16235682|NCT01118663|Drug|Acetadote|Acetadote [old formulation] 150 mg/kg in 200 mL diluent over 60 minutes; then Acetadote 50 mg/kg in 500 mL diluent over 4 hours; then Acetadote 100 mg/kg in 1000 mL diluent over 16 hours.
16235683|NCT01118637|Behavioral|StopPulling.com|subsidized access to an interactive self-help website for TTM
16235684|NCT01118624|Drug|Pralatrexate Injection|"Intravenous (IV) push administration over 3-5 minutes.
~Initial dose: 190 mg/m2
~Dose reductions per protocol: 150 mg/m2, 120 mg/m2, and 100 mg/m2 allowed for defined toxicities.
~Administered on days 1 and 15 of a 4-week cycle (every 2 weeks) until criteria for discontinuation per the protocol are met."
16235685|NCT01118624|Dietary Supplement|Vitamin B12|"1 mg intramuscular injection
~Administered within 10 weeks prior to first dose of pralatrexate, every 8-10 weeks throughout the study and for at least 30 days after the last dose of pralatrexate."
16235692|NCT01118598|Drug|tredaptive (nicotinic acid/ laropiprant)|tablet of nicotinic acid 1000 mg/laropiprant 20 mg one tablet of for 4 weeks followed by two tablets od for 8 weeks
16235693|NCT01118598|Drug|placebo|placebo tablet one a day for first 4 weeks followed by two a day for 8 weeks
16235694|NCT01118585|Procedure|TIF Procedure|The TIF procedure results in the creation of an esophago-gastric fundoplication extending up to 4 cm above the Z-line and 270 degrees around the esophagus.
16235695|NCT01118572|Drug|YM177|oral
16235696|NCT01118572|Drug|etodolac|oral
16235697|NCT01118572|Drug|Placebo|oral
16235698|NCT01118559|Drug|YM150|oral
16235699|NCT01118533|Device|metal reusable blades MacIntosh|laryngoscope blades
16235700|NCT01118533|Device|Single use plastic blades HEINE XP®|laryngoscope blades
16235701|NCT01118520|Drug|perindopril arginine|10mgs orally daily for the duration of the trial
16235702|NCT01118520|Drug|amlodipine 5mgs|5 mgs taken orally daily for the duration of the trial
16235703|NCT01118520|Drug|placebo|one daily
16235704|NCT01118455|Device|Vagus Nerve Stimulation (VNS) Therapy|Vagus Nerve Stimulation (VNS) Therapy is delivered by an implantable device similar to a pacemaker that sends mild stimulation to the left vagus nerve to help improve seizure control.
16235705|NCT01118455|Drug|Anti-Epileptic Drug (AED)|Subject has tried at least 2 appropriate AEDs tested to tolerance or to blood levels at upper end of the target range of which at least 2 had been tolerated at normal doses.
16235706|NCT01118429|Drug|Oxybutynin|Oxybutynin was prescribed for 12 weeks, in progressively increasing doses throughout treatment. At their first visit, the patients were given 2.5 mg of oxybutynin into be taken once a day in the evening, were instructed to increase the dose to 2.5 mg twice a day from the eighth to the 42nd day, and to contact the doctor if they experienced any side effect. After this period they were seen in a second visit, and the dose was increased to 5 mg twice a day from the 43rd to the end of the 84thday, to when a third visit was scheduled.
16235707|NCT01118429|Drug|Placebo|Oxybutyinine was prescribed for 12 weeks, in progressively increasing doses throughout treatment. At their first visit, the patients were given 2.5 mg of oxybutyn into be taken once a day in the evening, were instructed to increase the dose to 2.5 mg twice a day from the eighth to the 42nd day, and to contact the doctor if they experienced any side effect. After this period they were seen in a second visit, and the dose was increased to 5 mg twice a day from the 43rd to the end of the 84thday, to when a third visit was scheduled.
16235708|NCT01118416|Behavioral|HIV prevention intervention randomized control trial|Substance using HIV-negative young MSM who engage in sexual risk are randomized to either a motivational interviewing or an education condition to reduce sexual risk and drug use.
16235709|NCT01118403|Drug|Sultamicillin|Ampoules per 1.5 grams, three grams intravenously every 6 hours for 4 doses diluted in physiologic Sodium Chloride Solution
16235710|NCT01118390|Device|Laser Nd:YAG 1064nm|Patients with leg telangiectasias are treated with 3 sessions of Nd:YAG 1064nm, with 14 days interval
16235711|NCT01118390|Other|Sclerotherapy|Patients with leg telangiectasias are treated with 3 sessions of sclerotherapy, with 14 days interval
16235712|NCT01118377|Drug|Capecitabine|Capecitabine was supplied as film-coated tablets.
16235713|NCT01118377|Radiation|Radiation therapy|Local irradiation using conformal, volume-based delivery techniques. The nominal energy of the X-rays was ≥ 4 MV.
16235714|NCT01118364|Other|Cannabis|"a cigarette tobacco trade mark Drum with the addition of 250 mg of cannabis resin with 8% of D9THC (20 mg per cigarette)45 minutes before simulating or real driving"
16235715|NCT01118364|Other|tobacco|"a cigarette tobacco trade mark Drum 45 minutes before simulating or real driving"
16235716|NCT01118351|Drug|sunitinib malate|Given orally
16235717|NCT01118351|Other|immunohistochemistry staining method|Correlative studies
16235718|NCT01118351|Other|TdT-mediated dUTP nick end labeling assay|Correlative studies
16235719|NCT01118351|Other|light microscopy|Correlative studies
16235720|NCT01118351|Other|laboratory biomarker analysis|Correlative studies
16235721|NCT01118338|Device|Redesigned Purevision Contact Lens|Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.
16235722|NCT01118338|Device|PureVision Contact Lens|Lenses will be dispensed at screening visit, subjects will wear lenses on a daily wear basis for one month.
16235723|NCT01118325|Drug|ticagrelor|Drug oral treatment
16235724|NCT01118325|Drug|clopidogrel|Drug oral treatment
16235725|NCT01118312|Drug|Mometasone Furoate monohydrate|Intranasal mometasone, 1 spray (age < 12 yr) or 2 sprays (age >= 12 yrs) each nostril once a day for 6 months
16235726|NCT01118312|Other|Placebo|Intranasal placebo spray
16235727|NCT01118299|Device|AMPLATZER Cardiac Plug|AMPLATZER Cardiac Plug is a percutaneous transcatheter device
16235728|NCT01118286|Drug|Nifedipine (Adalat, BAYA1040)|Previously untreated hypertensive adult patients starting with combination therapy containing nifedipine or insufficiently controlled hypertensive patients receiving nifedipine as an add-on to existing non-CCB containing antihypertensive therapy. The decision of including the patient as well as decision on dosage and duration is taken by the investigator.
16235729|NCT01118273|Drug|Naproxen Sodium 440 mg (BAYH6689) / DPH 50mg|Participants received 2 tablets of Naproxen Sodium 220 mg and 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg, single dose, orally.
16235730|NCT01118273|Drug|Naproxen Sodium 440 mg (BAYH6689)|Participants received 2 tablets of Naproxen Sodium 220mg and 2 tablets of placebo, single dose, orally.
16235731|NCT01118273|Drug|Naproxen Sodium 220 mg (BAYH6689) / DPH 50mg|One dose of naproxen sodium 220 mg plus diphenhydramine 50 mg
16235732|NCT01118273|Drug|Naproxen Sodium 220 mg (BAYH6689)|Participants received 1 tablet of Naproxen Sodium 220 mg and 3 tablets of placebo, single dose, orally.
16235733|NCT01118273|Drug|DPH 50mg|Participants received 2 tablets of Diphenhydramine hydrochloride (DPH) 25 mg and 2 tablets of placebo, single dose, orally.
16235734|NCT01118273|Drug|Ibuprofen 400 mg / Diphenhydramine citrate 76 mg|Participants received 2 tablets of Advil PM (ibuprofen 200 mg and diphenhydramine citrate 38 mg) and 2 tablets of Placebo, single dose, orally.
16235735|NCT01118260|Procedure|total intravenous anaesthesia|propofol and remifentanil
16235736|NCT01118260|Procedure|spinal anaesthesia|bupivacaine and fentanyl
16235858|NCT01117441|Drug|prednisone|see detailed protocol description
16235737|NCT01118247|Procedure|Uncemented primary total hip arthroplasty|Total hip prosthesis partly coated with pure Ti with and without HA are compared in a RCT.
16235738|NCT01118234|Drug|Rituximab|Rituximab (MabThera, F. Hoffmann-La Roche Ltd., Basel, Switzerland) 375 mg/m² every 3 months for 24 months (8 infusions) or observation
16235739|NCT01118221|Behavioral|pulmonary rehabilitation|structured exercise program
16235740|NCT01118208|Other|Blister packaging medications|Dispensing prescription medications on pre-filled blister package cards.
16235741|NCT01118208|Other|Dispense as usual|Dispensing prescription medications in standard pill bottles.
16235742|NCT01118156|Other|Education|75-minute training teaching utilization of new standardized suicide nomenclature
16235743|NCT01118143|Behavioral|Tailored oral health literacy instruction|The intervention includes oral hygiene instruction tailored to the level of oral health literacy, and will include information about the outcome of the clinical examination. Providing relevant information to the participant will be in focus, and there will be given a personalized demonstration as well as guidance on how to conduct proper oral hygiene practices at home. The aim of the intervention is to improve oral hygiene and attitudes towards dental care by taking the literacy level of the participant into consideration.
16235744|NCT01118117|Device|Misago™ Self-Expanding Stent System|Transcatheter placement of an intravascular stent(s)
16235745|NCT01118104|Other|Vocational pulmonary rehabilitation|Multidisciplinary pulmonary rehabilitation with emphasis on vocational issues
16235746|NCT01118091|Biological|Aldesleukin|Aldesleukin 720,000 IU/kg IV over 15 minute every eight hours and continuing for up to 5 days (maximum of 15 doses). Patients will receive one additional cycle of aldesleukin approximately 10-14 days after completion of the first cycle of aldesleukin.
16235747|NCT01118091|Biological|CD8 enriched Young TIL|Adoptive Cell Therapy consisting of the lymphocyte depleting preparative regimen consisting of fludarabine and cyclophosphamide, followed by infusion of between 1x10^9 to 2x10^11 CD8+ enriched tumor infiltrating lymphocytes (minimum of 5 x 10^8) and the administration of high-dose aldesleukin.
16235748|NCT01118078|Genetic|DNA methylation analysis|Undergo DNA methylation analysis
16235749|NCT01118078|Genetic|gene expression analysis|Undergo gene expression analysis
16235750|NCT01118078|Genetic|microarray analysis|Undergo microarray analysis
16235751|NCT01118078|Genetic|reverse transcriptase-polymerase chain reaction|Undergo RT-PCR
16235752|NCT01118078|Other|diagnostic laboratory biomarker analysis|Correlative studies
16235753|NCT01118065|Drug|everolimus|
16235754|NCT01118052|Other|Laboratory Biomarker Analysis|Correlative studies
16235755|NCT01118052|Biological|PEG-PEI-cholesterol Lipopolymer-encased IL-12 DNA Plasmid Vector GEN-1|Given intraperitoneally
16235756|NCT01118039|Drug|sunitinib malate|
16235757|NCT01118039|Other|immunohistochemistry staining method|
16235758|NCT01118039|Other|laboratory biomarker analysis|
16235759|NCT01118039|Other|pharmacological study|
16235760|NCT01118039|Procedure|quality-of-life assessment|
16235761|NCT01118026|Drug|ABVD|doxorubicin 25 mg/m^2 IV bleomycin 10 units/m^2 IV vinblastine 6 mg/m^2 IV dacarbazine 375 mg/m^2 IV
16235762|NCT01118026|Drug|BEACOPP|bleomycin 10 units/m^2 IV on Day 8 etoposide 200 mg/m^2 IV on Days 1, 2 and 3 doxorubicin 35 mg/m^2 IV on Day 1 cyclophosphamide 1250 mg/m^2 IV on Day 1 vincristine 1.4 mg/m^2 IV on Day 8 procarbazine 100 mg/m^2 orally on Days 1-7 prednisone 40 mg/m^2 orally on Days 1-14
16235763|NCT01118026|Radiation|radiation therapy|
16235764|NCT01118013|Biological|anti-thymocyte globulin|
16235765|NCT01118013|Biological|donor lymphocytes|
16235766|NCT01118013|Biological|filgrastim|
16235767|NCT01118013|Biological|therapeutic allogeneic lymphocytes|
16235768|NCT01118013|Drug|busulfan|
16235769|NCT01118013|Drug|fludarabine phosphate|
16235770|NCT01118013|Drug|methotrexate|
16235771|NCT01118013|Drug|mycophenolate mofetil|
16235772|NCT01118013|Drug|tacrolimus|
16235773|NCT01118013|Other|reduced-intensity transplant conditioning procedure|
16235774|NCT01118013|Procedure|allogeneic hematopoietic stem cell transplantation|
16235775|NCT01118013|Procedure|peripheral blood stem cell transplantation|
16235776|NCT01118000|Procedure|limb ischemia preconditioning|limb ischemic preconditioning consists of three 5-min cycles of left upper limb ischemia induced by a blood pressure cuff placed on the left upper arm and inflated to 200 mmHg,with an intervention 5-min of reperfusion during which the cuff was deflated.
16235777|NCT01117987|Drug|Imatinib|Participants, who received imatinib 200 mg in the core study, CQTI571A2301 (NCT00902174), and completed the core study, received imatinib 200 mg every day (qd) in the extension. Participants, who were randomized to receive imatinib 400 mg in the core study and completed the core study, received imatinib 400 mg qd in the extension. Participants, who terminated early from the core study or who were randomized to placebo and completed the core study, started the extension with imatinib 200 mg qd. After 2 weeks, the dose was increased to 400 mg qd if tolerated.
16235778|NCT01117987|Drug|Placebo|To preserve the blind of the core study until the core study, CQTI571A2301 (NCT00902174), was completed, participants received a blinded study drug package containing a 70-tablet bottle of imatinib and a 70-tablet bottle of matching placebo.
16235779|NCT01117974|Procedure|liposuction of the neck|Liposuction will be performed to the surgical endpoint (skin thickness in the suctioned areas similar to that of surrounding non-treated skin).
16235780|NCT01117961|Behavioral|Lifestyle|Behavioral lifestyle intervention targeting diet and physical activity to reduce excessive gestational weight gain
16235781|NCT01117948|Drug|Lornoxicam|Lornoxicam (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
16235782|NCT01117948|Drug|Placebo|Placebo (8 mg) tablets to be taken orally two times daily (BID) for a period of 6 months.
16235783|NCT01117935|Radiation|intensity modulated external beam radiation therapy|"Low risk - 69.6 Gy in 2.4 Gy fractions to prostate
~Intermediate risk - delivered in 30 fractions with neoadjuvant and concurrent androgen deprivation therapy: 72 Gy in 2.4 Gy fractions to prostate + 60 Gy in 2 Gy fractions to seminal vesicles +/- 50.4 Gy in 1.68 Gy fractions to lymph nodes
~High risk - 30 fractions with neoadjuvant, concurrent, and long term adjuvant androgen deprivation therapy: 72 Gy in 2.4 Gy fractions to prostate + 60 Gy in 2 Gy fractions to seminal vesicles +/- 50.4 Gy at 1.68 Gy fractions to lymph nodes"
16235859|NCT01117441|Drug|thioguanine|see detailed protocol description
16235784|NCT01117922|Other|Psychological intervention|Subjects will be randomized into either usual care or interconceptional intervention groups. If the subject is randomized into the intervention group, she will receive targeted interventions to reduce one of several risk factors: smoking, depression, infectious disease burden and maternal stress, and achieving an appropriate BMI. A woman who is randomized to the intervention group may receive interventions on one, two, three, four, or five of the targeted intervention methods, depending on her needs.
16235785|NCT01117922|Other|Usual Care Group|
16235786|NCT01117909|Other|Mobilization therapy in addition to standard therapy|Subject will receive three 60-second bouts of posterior joint mobilizations applied to the ankle joint during each treatment session. Standard therapy will consist of ankle strengthening exercises with elastic bands, balance, active ROM, and 20 minutes of ice bag application, elevation and compression.
16235787|NCT01117909|Other|Sham intervention|Physical therapist will lay hands as if to perform the joint mobilization but no movement will occur.
16235788|NCT01117896|Other|Chest compression on adult and pedi manikins|Each participant will be required to perform chest compressions on all 2 manikins, one on each of 2 assigned days. Participants will be randomized to one of 2 groups differing only in the order of manikins compressed, i.e. pediatric-adult; adult-pediatric, etc.
16235789|NCT01117896|Other|Use of stepstool during chest compressions|In the additional arm of the study, a new cohort of participants will use only the adult manikin on two separate sessions. Participants will be randomized to one of two groups differing only in the use of a stepstool.
16235790|NCT01117883|Other|Application of two different sternal weights|Two separate weights (first 10% of body weight, then 20% of body weight) will be placed on the sternum and changes in central hemodynamic measurements and intrathoracic pressure will be recorded and documented.
16235791|NCT01117870|Other|Pulsed Radiofrequency|120 seconds at 42 degrees celsius
16235792|NCT01117870|Other|Placebo|Needle will be continuously stimulated at a low voltage to give a sensation of PRF application.
16235793|NCT01117857|Drug|Duloxetine|One-week placebo lead-in, followed by Duloxetine 30 mg per day for one week. After one week on 30 mg, the dosage will be increased 60 mg per day for the remaining 7 weeks of the study.
16235794|NCT01117844|Radiation|Proton Radiation|Protons have been demonstrated for medulloblastoma and prostate cancer, and comparative treatment planning using protons versus photons have shown a clear advantage to protons in terms of dose distribution.
16235795|NCT01117831|Other|Epidemiological intervention|An analysis of 600 diabetic patients in the Island of PR to evaluate metabolic control.
16235796|NCT01117818|Biological|active: AFFITOPE AD02|vaccination
16235797|NCT01117818|Biological|control: Placebo|vaccination
16235798|NCT01117805|Behavioral|Telephone counseling intervention|self-regulation telephone counseling program for African American women with asthma
16235799|NCT01117792|Device|subcutaneous implantable defibrillator (S-ICD) system|implantable defibrillator system
16235800|NCT01117779|Device|Cryoablation|Cryoablation (freezing) with Galil Medical cryoablation systems and needles under imaging guidance
16235801|NCT01117766|Drug|Pregabalin|Dose titration according to following regimen: 75mg BID for 3 days; 150mg for 4 days; 225mg BID for 4 days; 300mg BID for 17 days. Dose reduced for renally impaired patients
16235802|NCT01117766|Drug|Placebo|BID dosing for 28 days
16235803|NCT01117753|Behavioral|OutPatient Treatment for Adolescents (OPT-A)|
16235804|NCT01117753|Behavioral|Treatment As Usual|
16235805|NCT01117740|Behavioral|MDASI Questionnaire|19 question M. D. Anderson Symptom Inventory (MDASI) before pleural effusion treatment and at each follow-up visit, takes about 5 minutes to complete each time.
16235806|NCT01117727|Device|Brain Computer Interface Switch|Subjects will wear an EEG cap for 1-2 hours typical per session and use the brain computer interface to operate assistive technology. Subjects will be asked to participate in 14-20 sessions.
16235807|NCT01117714|Procedure|Integrated Staging for Early Detection of Metastases in Lung Cancer|To determine the accuracy of EBUS/EUS-guided FNA when compared with surgical mediastinoscopy/thoracoscopy
16235808|NCT01117701|Procedure|Ureteroscopy with and without safety guidewire|In study arm A - with SGW, the force measurements are made with a safety guidewire in place. In study arm B - without SGW, the force measurements are made without SGW.
16235809|NCT01117688|Procedure|Ureteroscopy with and without safety guidewire|In study arm A - with SGW, endoscopic treatment is performed with a safety guidewire in place. In study arm B - without SGW, the ureteroscopy is performed without SGW.
16235810|NCT01117675|Other|Virtual Hospital|A new home care model using a telemedicine system (Virtual Hospital) to care chronic HIV-infected patients
16235811|NCT01117675|Other|Standard of Care|Standard of Care
16235812|NCT01117662|Drug|Rituximab|Intravenous application of Rituximab 375mg/m² body surface in 250 ml NaCl 0,9 % over 4 hours
16235813|NCT01117662|Drug|Placebo|Intravenous application of placebo (NaCl 0,9 %) matching active treatment
16235814|NCT01117649|Drug|HES 10%|HES 10% dissolved in plasma adapted Ringer's solution (balanced solution).
16235815|NCT01117649|Drug|HES 6%|HES 6% dissolved in plasma adapted Ringer's solution (balanced solution)
16235816|NCT01117649|Drug|balanced electrolyte solution|plasma adapted Ringer's solution
16235817|NCT01117636|Drug|Acetylsalicylic acid (Fast release Aspirin, BAY1019036)|Single oral dose of fast release aspirin tablets 1000 mg (2 x 500 mg) with a full glass of water (240 milliliter [mL]) between 14 hours post dental surgery.
16235818|NCT01117636|Drug|Acetylsalicylic Acid (Aspirin, BAYE4465)|Single oral dose of regular aspirin tablet 1000 mg (2 x 500 mg) with a full glass of water (240 mL) between 14 hours post dental surgery.
16235819|NCT01117636|Drug|Placebo|Single oral dose of 2 placebo tablets with a full glass of water (240 mL) between 14 hours post dental surgery.
16235820|NCT01117623|Drug|Escalation cohort: Regorafenib (Stivarga, BAY73-4506) 20 mg|Participants in the dose-escalation cohort received a single 20 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 20 mg oral co-precipitate (CP) tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
16235860|NCT01117441|Drug|vincristine sulfate|see detailed protocol description
16235861|NCT01117441|Drug|vindesine|see detailed protocol description
16236542|NCT01111968|Biological|pandmeic vaccine 11|7,5µg of A/H1N1 with Al(OH)3
16235821|NCT01117623|Drug|Escalation cohort: Regorafenib (Stivarga, BAY73-4506) 40 mg|Participants in the dose-escalation cohort received a single 40 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 40 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
16235822|NCT01117623|Drug|Escalation cohort: Regorafenib (Stivarga, BAY73-4506) 100 mg|Participants in the dose-escalation cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
16235823|NCT01117623|Drug|Escalation cohort: Regorafenib (Stivarga, BAY73-4506) 120 mg|Participants in the dose-escalation cohort received a single 120 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 120 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
16235824|NCT01117623|Drug|Escalation cohort: Regorafenib (Stivarga, BAY73-4506) 140 mg|Participants in the dose-escalation cohort received a single 140 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 140 mg oral CP tablets was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
16235825|NCT01117623|Drug|HCC Child-Pugh A expansion cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh A in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
16235826|NCT01117623|Drug|HCC Child-Pugh B expansion cohort: Regorafenib 100 mg|Hepatocellular carcinoma (HCC) Participants with Child Pugh B in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
16235827|NCT01117623|Drug|NSCLC expansion cohort: Regorafenib 100 mg|Non-small cell lung cancer (NSCLC) participants in the expansion cohort received a single 100 mg oral CP tablet of regorafenib on Day 1 of Cycle 1 followed by 1 day off treatment. On Day 3, once-daily continuous dosing with 100 mg oral CP tablets of regorafenib was initiated. A cycle was defined as 21 days. For Cycle 2 and subsequent cycles, regorafenib was administered once daily continuously on a 21-day cycle.
16235828|NCT01117610|Drug|Placebo (one of medication)|patients in Group C will receive none of medication preoperatively and intraoperatively
16235829|NCT01117610|Drug|Ropivacaine (epidural injection)|patient in group I will receive epidural injection of 0.1% ropivacaine 10ml before skin incision.
16235830|NCT01117597|Radiation|low RF exposure level|Exposure with 1.5 W/kg
16235831|NCT01117597|Radiation|sham exposure|intervention with sham RF exposure
16235832|NCT01117597|Radiation|high RF exposure|intervention with high RF exposure
16235833|NCT01117584|Drug|ipragliflozin|oral tablet
16235834|NCT01117584|Drug|Placebo|oral tablet
16235835|NCT01117584|Drug|Metformin|oral tablet
16235836|NCT01117571|Device|iUni® Unicompartmental Knee Resurfacing Device|The iUni® Unicompartmental Resurfacing Device is an FDA cleared and CE Marked implant designed for patients with damage isolated to either the medial or lateral tibiofemoral compartment of the knee. The patient-specific iUni is designed from a CT scan of an individual patient's knee using a design process which interactively maps the diseased area and defines the extent of misalignment present in the knee. This process allows definition of the shape and size of the femoral and tibial components of the implant, as well as the disposable instrumentation
16235837|NCT01117545|Behavioral|EFT (Emotional Freedom Techniques)|Six sessions of EFT
16235838|NCT01117532|Behavioral|EFT (Emotional Freedom Techniques)|Four 90 minute group therapy classes of this behavioral intervention
16235839|NCT01117519|Drug|Infusion Therapy|Based on changes of stroke volume measured by transoesophageal doppler patients during elective hip surgery will achieve either a unbalanced infusion solution, maximum dose of 100 ml/kg BW, or a compound of balanced infusion solution including 50% crystalloid and 50% colloid, each: maximum dose of 50 ml/kg BW. The study medication will be administered only during surgery.
16235840|NCT01117506|Diagnostic Test|Corus CAD (ASGES)|Age/Sex/Gene Expression Score - ASGES
16235841|NCT01117493|Behavioral|Expert Patient Programme|Intervention was a disease specific Expert Patient Programme in addition to usual care. The disease specific Expert Patient Programme was delivered one session per week (lasting 2½ hours) for eight weeks and included 2 weeks disease specific education followed by 6 weeks standardised Expert Patient Programme.
16235842|NCT01117493|Behavioral|Usual care|Usual care included reviews at a specialist respiratory clinic on a three monthly basis to monitor spirometry, inflammatory blood markers and sputum microbiology. The patients were prescribed inhaled therapy and antibiotics if required, and treatment adjusted to the needs of the patient as necessary, including hospital admission.
16235843|NCT01117467|Other|Simulation scenario|Students performing their scenario will be paired, not solo
16235844|NCT01117467|Other|Simulation scenario|Students will perform their simulation scenario solo and receive feedback within the group
16235845|NCT01117454|Drug|Flecainide Acetate|oral flecainide with the dose titrated to achieve a serum level between 0.5-0.8 mcg/ml
16235846|NCT01117454|Drug|Placebo|placebo, similar in appearance to flecainide
16235847|NCT01117454|Drug|Beta blocker|Standard therapy with beta-blocker (nadolol, atenolol, metoprolol, or propranolol) continues throughout the trial.
16235848|NCT01117441|Drug|PEG-L-asparaginase|see detailed protocol description
16235849|NCT01117441|Drug|cyclophosphamide|see detailed protocol description
16235850|NCT01117441|Drug|cytarabine|see detailed protocol description
16235851|NCT01117441|Drug|daunorubicin hydrochloride|see detailed protocol description
16235852|NCT01117441|Drug|dexamethasone|see detailed protocol description
16235853|NCT01117441|Drug|doxorubicin hydrochloride|see detailed protocol description
16235862|NCT01117441|Drug|daunoxome|see detailed protocol description; only given by patients with poor MRD-response during the high risk treatment
16235863|NCT01117441|Drug|fludarabine|see detailed protocol description; only given by patients with poor MRD-response during the high risk treatment
16235864|NCT01117441|Radiation|Radiation Therapy|for eligibility for radiotherapy see detailed protocol description
16235865|NCT01117428|Drug|Sym004|"In part A, patients in all dose cohorts will continue weekly treatment with the assigned dose of Sym004 until disease progression.
~In Part B, patients will continue weekly treatment with the tolerated dose of Sym004 until disease progression.
~In Part C, patients will receive weekly doses of Sym004 at the dose level below 12 mg/kg i.e. 9 mg/kg until disease progression.
~In Part D and E, patients will receive doses of Sym004 administered every 2 weeks at dose level 12 mg/kg and 18 mg/kg, respectively until disease progression.
~In Part F, patients will receive a single loading dose of 9 mg/kg followed by weekly doses of 6 mg/kg."
16235866|NCT01117402|Radiation|Radiotherapy|"Patients will receive external radiation therapy using IMRT to pelvis. Treatment volume (CTV, vault and uninvolved pelvic nodes) will receive a dose of 50-56Gy over 25-28# and gross pelvic nodes will receive 55-62Gy over 25-28 fractions over 5 weeks. Pre RT daily MV CT imaging would be done on Tomotherapy to look and correct for any set up error or anatomic variations.
~Chemotherapy will be given weekly - cisplatin 40mg/m2 with prechemo medication. After completion of IMRT all patients will be evaluated for boost to vaginal vault with interstitial template brachytherapy to a dose of 16-20 Gy with HDR in 4-5 fractions. Patients not eligible for brachytherapy will get additional boost to vault and parametrium by EBRT to a dose of 15-20Gy in 6-8 fractions."
16235867|NCT01117376|Drug|Erythromycin|Erythromycin 250 mg intravenous Q6h for 4 doses
16235868|NCT01117376|Drug|Methylnaltrexone|Methylnaltrexone 12 mg subcutaneous Q12h for 2 doses
16235869|NCT01117363|Other|dietary intervention (rye porridge or wheat bread)|A breakfast consisting of either active (rye porridge) or control (wheat bread) is given during 2 3-wk intervention periods in a randomized cross-over design. The two dietary intervention periods are separated by a 3-4 wks wash out.
16235870|NCT01117350|Drug|Insulin glargine|100 Units/mL solution for injection in a pre-filled SoloStar pen
16235871|NCT01117350|Drug|Liraglutide|6 mg/mL solution for injection in a 3-mL pre-filled pen (18mg)
16235872|NCT01117350|Drug|Metformin|Metformin was a background treatment, mandatory for each patient randomized in the study (at the minimum dose of 1g/day). It was not supplied by the sponsor.
16235873|NCT01117337|Procedure|Mesh Fixation|Laparoscopic Total extraperitoneal repair of Inguinal hernia under Spinal Anesthesia - Mesh is not fixed to any structure
16235874|NCT01117311|Device|VNB on|The implanted Vagal Nerve Blocker will be on at the time of study.
16235875|NCT01117311|Device|VNB off|The implanted Vagal Nerve Blocker will be off at the time of study.
16235876|NCT01117298|Drug|Tadalafil|Tab Tadalafil, 20 mg alternate day for 8 weeks
16235877|NCT01117298|Drug|Placebo|Tab Placebo every alternate day for 8 weeks
16235878|NCT01117285|Other|3-day post-graduate course|"A 3-day course in using the COTiD program in clinical practice. The 3 days are not provided uninterrupted but there are at least two weeks between each day to provide time to practice with the guideline (for discussion on the 2nd day).
~The course consists of theory on the content of the guideline and its effectiveness, Practice parts of the guideline by rol playing, and discussing each others skills through watching video material."
16235879|NCT01117285|Other|Combined implementation strategy|"The combined implementation strategy provides strategies for occupational therapists (OTs), physicians, and managers.
~OTs receive:
~3-day post-graduate course
~2 extra training days: Lectures and skills practice focused on using the COTiD program and promoting the use of the program within their organization and network.
~Coaching on the job: Barriers to using the COTiD program in practice are discussed using motivational interviewing.
~Discussion platform
~Web-based registration system: Provides guidance in using the COTiD program for every individual client.
~Regional meetings: successes and difficulties in using the COTiD are discussed.
~Managers and physicians receive:
~Information on the COTiD program through a website and newsletters.
~Motivational reminders."
16235880|NCT01117246|Device|High Intensity Focused Ultrasound|HIFU is the use of focused ultrasound energy to penetrate through soft tissue and causes localized high temperatures (55°C to 70°C) for a few seconds within the target producing well defined regions of protein and nerve denaturation, irreversible cell damage, and coagulative necrosis.
16235881|NCT01117233|Drug|PF-04427429|single intravenous infusion of 10 mg PF-04427429 or placebo
16235882|NCT01117233|Drug|PF-04427429|single intravenous infusion of 30 mg PF-04427429 or placebo
16235883|NCT01117233|Drug|PF-04427429|single intravenous infusion of 100 mg PF-04427429 or placebo
16235884|NCT01117233|Drug|PF-04427429|single intravenous infusion of 300 mg PF-04427429 or placebo
16235885|NCT01117233|Drug|PF-04427429|single intravenous infusion of 1000 mg PF-04427429 or placebo
16235886|NCT01117220|Drug|Placebo|Placebo matching the oral ziprasidone capsules of 20,40, 60 and 80 mg in strength. Subjects will be dosed for 4 weeks using a flexible dose design with minimal dose range of 40 mg twice a day (BID) to maximum dose range of 80 mg BID (weight specific- < 45kg max dose 40 mg BID).
16235887|NCT01117220|Drug|Ziprasidone Oral Capsules|Oral ziprasidone capsules of 20,40, 60 and 80 mg in strength. Subjects will be dosed for 4 weeks using a flexible dose design with minimal dose range of 40 mg twice a day (BID to maximum dose range of 80 mg BID (weight specific- < 45kg max dose 40 mg BID).
16235888|NCT01117194|Device|Rehabilitation Robot for Upper Limb Dysfunction (NTUH Model One)|Use an intelligent robot to assist upper limb rehabilitation.
16235889|NCT01117181|Drug|Methylphenidate|The target dose is 20 mg per day provided as two 10 mg doses administered orally. Patients will start by taking 10 mg daily (two 5 mg over-encapsulated tablets) for three days, at which time the dose will be increased to 20 mg per day (four 5 mg over-encapsulated tablets). In the event of significant side-effects, the dose will be reduced to a minimum of 10 mg per day. The study drug will be administered for 6 weeks.
16235890|NCT01117181|Drug|placebo|Patients will start with two capsules of placebo for three days, at which time the dose will be increased to four capsules. The dose may be reduced to a minimum of two capsules per day if there appears to be significant side-effects. Placebo will be administered for 6 weeks.
16235978|NCT01116492|Other|Laparoscopic cholecystectomy|Standard 4 port laparoscopic cholecystectomy
16235979|NCT01116479|Other|Blood transfusion|Blood transfusion with packed erythrocytes
16235891|NCT01117181|Other|Psychosocial intervention|"The psychosocial intervention will consist of three components: a counseling session, the provision of education materials, and 24-hour availability for crises.
~The counseling session, in which a trained study clinician will counsel the primary caregiver, lasts approximately 20-30 minutes, and consists of the following elements:
~Review and adjustment of the patient and caregiver supportive care plans
~Emotional support and opportunity to ventilate feelings
~Counseling regarding specific caregiving skills
~Assistance with problem solving of specific issues that the caregiver brings to the sessions
~Answers for questions regarding the educational materials
~The educational materials will consist of a copy of the book The 36-Hour Day"
16235892|NCT01117129|Drug|rituximab [MabThera/Rituxan]|1000 mg by i.v. infusion on day 1 and 15
16235893|NCT01117129|Drug|placebo|i.v. infusion on day 1 and 15
16235894|NCT01117129|Drug|methotrexate|10-25 mg weekly
16235895|NCT01117129|Drug|rituximab [Mabthera/Rituxan]|1000 mg by i.v. infusion on day 1 and 15, 2nd and further cycles in patients with (group A) or without (group B) clinical response in cycle 1
16235896|NCT01117116|Drug|fluticasone propionate and salmeterol|45/4.5 two puffs twice daily
16235897|NCT01117116|Drug|budesonide and formoterol|80/4.5 two puffs twice daily
16235898|NCT01117064|Device|Neuromodulation Therapy Device (NMTD)|Subjects will have an overnight PSG using CPAP (as previously titrated) for half of the night and NMTD the other half (this order will be randomized). we will monitor NMTD's influence on Apnea Hypopnea Index (AHI), sleep architecture, arousal index, and sleep efficiency compared to the same variables during CPAP use
16235899|NCT01117064|Device|Neuromodulation Therapy Device (NMTD)|Subjects will have an overnight PSG using the NMTD. This device detects reduced airflow via a polymer sensor. When such event is detected, a short burst of sound is administered via earphones. We will determine NMTD's operating characteristics for treatment of OSA. The optimal duration of a detected apnea/hypopnea event before NMTD responds must first be determined. Additional adjustable features include sensitivity of respiratory event sensor, as well as pulse duration, frequency, and intensity of the delivered auditory tone. Since independent adjustment of each of the 4 parameters is not feasible, our screening analysis will test two variables at a time to identify which variables most effectively reduce AHI.
16235900|NCT01117064|Device|Neuromodulation Therapy Device (NMTD)|Subjects will undergo two sequential nights of PSG with NMTD to evaluate if there is any stimulus-response extinction over time.
16235901|NCT01117051|Drug|placebo|placebo
16235902|NCT01117051|Drug|prucalopride|1 or 2 mg prucalopride once daily before breakfast
16235903|NCT01117038|Drug|avanafil and enalapril|enalapril twice a day for 11 days avanafil/placebo once a day for 2 days
16235904|NCT01117038|Drug|avanafil and amlodipine|amlodipine 5mg once a day for 16 days avanafil/placebo once a day for 3 days
16235905|NCT01117025|Procedure|Circumferential PV isolation|The left atrium (LA) and pulmonary veins (PVs) are explored through a transeptal approach. Real-time 3D LA maps are reconstructed by using a nonfluoroscopic navigation system. The ipsilateral left and right PVs are encircled in one lesion line by circumferential PV isolation. Radiofrequency energy is delivered at 43°C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and is reduced to 43°C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation speed of 17 mL/min. Each lesion is ablated continuously until the local potential amplitude decreased by >80% or RF energy deliveries exceeded 40 s. The endpoint of circumferential PV isolation is PV isolation. Additional ablation lines are created by connecting the left inferior PV to the mitral annulus (mitral isthmus) and the roof of the LA between the two superior PVs. After the end of the procedure the implantable loop recorder is implanted in the parasternal area of the chest.
16235906|NCT01117025|Procedure|Circumferential PVI+renal denervation|"The procedure of AF ablation is the same like in the circumferential PV isolation.
~After AF ablation procedure, the angiogram of both renal arteries is performed via femoral access. After that the treatment catheter is introduced into each renal artery and is applied discrete, radiofrequency ablations lasting up to 2 min each and of 8 watts or less to obtain up to six ablations separated both longitudinally and rotationally within each renal artery. During ablation, the catheter system monitored tip temperature and impedance, altering radiofrequency energy delivery in response to a predetermined algorithm. After the procedure the control arterial angiogram should be done."
16235907|NCT01117012|Drug|Ivacaftor|
16235908|NCT01116999|Procedure|light guided tracheal intubation|Tracheal intubation light guided technique.
16235909|NCT01116986|Behavioral|Counseling before quit attempt|Participants randomized to this condition will have 20-minute in-person counseling sessions 1 and 3 weeks before their target quit day and a 20-minute phone counseling session 2 weeks before their target quit day. In the in-person counseling session, the case manager will address issues such as smoking reduction, withdrawal coping, environmental restrictions on smoking, intra-treatment social support, autonomous motivation, and practice quit attempts. Participants will be asked to engage in two practice quit attempts. These attempts will each last 8 hours and will be assigned (in collaboration with the smoker) to occur on one weekend day and one weekday the second and third weeks after the quit day.
16235910|NCT01116986|Behavioral|Minimal In-person counseling during quit attempt|Participants randomized to minimal in-person counseling will receive one 3-minute in-person session occurring one week before their target quit day. The clinician will also inform the participant of the sort of phone counseling follow-up that s/he will receive in 1 and 2 weeks after their quit date. (This resembles the real-world situation in which the clinician discusses the sort of follow-up intervention a patient will receive.)
16235911|NCT01116986|Behavioral|Intensive in-person counseling during the quit attempt|Participants randomized to intensive in-person counseling will receive three 20-minute face-to-face counseling sessions: one during the week before the target quit day, one on the target quit day and one during the week after the target quite day. The counseling will include intra-treatment social support and skill-based competence intervention components.
16235912|NCT01116986|Behavioral|Minimal phone counseling during the quit attempt|Participants randomized to this condition will receive minimal phone counseling consisting of one 10-minute phone counseling session on the morning of the target quit day. This session will address motivation to quit, strategies for coping with urges to smoke and use of the medication, and will provide support. Thus, all participants will get some counseling support on the quit day, which reflects the fact that initial lapses often occur on the target quit day, and quit day smoking is an important determinant of ultimate outcome.
16238006|NCT01100801|Drug|TS-1 with cisplatin|
16235913|NCT01116986|Behavioral|Intensive phone counseling during the quit attempt|Participants randomized to this condition will receive intensive phone counseling consisting of three 15-minute phone sessions (on the morning of the target quit day and on days 2 and 10 after the quit day). The content of the target quit day phone call will emphasize intra-treatment social support, skill execution and avoidance of danger situations. The quit day phone call is intended to augment any other clinician counseling received either on the phone or in person; such interventions tend to have additive effects and produce strong dose-response effects as a function of the duration of the counseling intervention.
16235914|NCT01116986|Drug|Long Term Nicotine Patch+ Nicotine Gum During Quit Attempt|"If randomized to this condition:
~After the target quit day:
~Patch:
~IF > 10 cigs/day: one 21 mg nicotine patch per day for 12 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
~IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 12 weeks, then one 7 mg for 4 weeks.
~Gum:
~IF > 24 cigs/day: ten 4 mg nicotine gum per day for 16 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine patch per day for 16 weeks."
16235915|NCT01116986|Drug|Short Term Nicotine Patch + Nicotine Gum during the quit attempt|"If randomized to this condition:
~After the target quit day:
~Patch:
~IF > 10 cigs/day: one 21 mg nicotine patch per day for 4 weeks, THEN one 14 mg nicotine patch per day for 2 weeks, THEN one 7 mg nicotine patch per day for 2 weeks.
~IF < or = 10 cigs/day: one 14 mg nicotine patch per day for 4 weeks, then one 7 mg for 4 weeks.
~Gum:
~IF > 24 cigs/day: ten 4 mg nicotine gum per day for 8 weeks. IF < or = 24 cigs/day: ten 2 mg nicotine gum per day for 8 weeks."
16235916|NCT01116986|Drug|Pre-Quit Nicotine Gum|"If randomized to only the Pre-Quit Nicotine Gum condition (and not the Pre-Quit Nicotine Patch):
~Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks before the target quit day."
16235917|NCT01116986|Drug|Pre-Quit Nicotine Patch|"If randomized to only the Pre-Quit Nicotine Patch condition (and not the Pre-Quit Nicotine Gum):
~Before quitting: Everyone will have one 14 mg nicotine patch per day for 2 weeks before the target quit day."
16235918|NCT01116986|Drug|Pre-Quit Nicotine Patch + Pre-Quit Nicotine Gum|"If randomized to both the Prequit Patch and Prequit Gum Conditions:
~Before quitting: Everyone will have ten 2 mg nicotine gum per day for 2 weeks and one 14 mg nicotine patch per day for 2 weeks before the target quit day."
16235919|NCT01116973|Other|PICC|Peripheral inserted catheter placement to take the reading
16235920|NCT01116947|Other|Meals during hemodialysis accompanied by lanthanum carbonate to control phosphorus|Based on the hypothesis that the efficacy and potency of Fosrenol enables increasing dietary protein intake and provision of meals during dialysis treatment for improving nutritional status in malnourished dialysis patients with a low serum albumin (<4.0 g/dL) while serum phosphorus can be effectively controlled with the target range of 3.5 to 5.5 mg/dL
16235921|NCT01116921|Device|Nasal continuous positive airway pressure (nCPAP)|nCPAP equipment used in the trial will be the standard hospital equipment used in the NICU.
16235922|NCT01116921|Device|Laryngeal Mask Airway (LMA) to deliver surfactant|Laryngeal Mask Airway (LMA Unique-Size 1, The Laryngeal Mask Company Limited, San Diego, CA)
16235923|NCT01116921|Drug|Surfactants, Pulmonary|Curosurf®, Chiesi USA, Inc., Cary, NC
16235924|NCT01116908|Device|LifeStraw Family|LifeStraw Family is a household water treatment technology that will be implemented in the household to improve drinking water quality
16235925|NCT01116895|Drug|LEO 22811|Oral solution
16235926|NCT01116895|Drug|Placebo|Placebo
16235927|NCT01116882|Procedure|PCI|
16235928|NCT01116856|Other|Exercise|Different groups will carry out different exercise protocols during 16 weeks under the same nutritional intervention.
16235929|NCT01116843|Drug|PF-00299804|PF-00299804 or Placebo given pre-operatively for 7 to 11 days depending on surgery schedule.
16235930|NCT01116830|Drug|Placebo|Orally daily for 6 weeks
16235931|NCT01116830|Drug|RO4917838|10 mg daily orally for 6 weeks
16235932|NCT01116830|Drug|Standard Antipsychotic Therapy|Participants will continue to receive their current antipsychotic treatment (as they are receiving at the time of screening). Protocol does not specify any particular standard antipsychotic therapy.
16235933|NCT01116817|Drug|Lumbar puncture (Lopinavir/ritonavir monotherapy)|Lumbar puncture at week 0
16235934|NCT01116817|Drug|Lumbar puncture (HAART: Lopinavir/ritonavir + 2 NRTI)|Lumbar puncture at week 0
16235935|NCT01116804|Procedure|MRI of the liver before start of treatment|MRI of the liver as classic work out of patients (CT-scan if MRI is contra-indicated)
16235936|NCT01116804|Procedure|MRI after treatment|MRI of the liver after 3 - 6 months of treatment (CT-scan if MRI is contra-indicated)
16235937|NCT01116804|Procedure|PET-scan before treatment start|PET-scan with 2 tracers is performed before treatment start
16235938|NCT01116804|Procedure|PET scan after treatment|PET-scan with 2 tracers is repeated 4 weeks following start of treatment
16235939|NCT01116791|Procedure|Cytoreductive Surgery (CRS) plus Hyperthermic Intraoperative Peritoneal Chemotherapy with Cisplatin (HIPC)|"CRS is defined as macroscopic tumour removal using surgical resection and/or local ablative therapy (LAT)
~HIPC is administered immediately after CRS"
16235940|NCT01116778|Biological|eN-Lac®|One capsule with 2x10^9 colony forming unit (cfu) LP GMNL-32, once daily, po
16235941|NCT01116778|Other|Placebo|One placebo capsule, once daily, po
16235942|NCT01116765|Other|no stimulation of the oral structure|
16235943|NCT01116765|Other|stimulation of the oral structure|
16235944|NCT01116752|Other|Active Glycemic Control Strict (80-140mg/dL) vs. Conservative (190-220mg/dL) (with or without Continuous Glucose Monitoring)|In addition to glycemic control in 2 groups, all children <1 year old and 25% of those >1 year old, will be able to receive continuous glucose monitoring via interstitial glucometry.
16235945|NCT01116739|Device|Fluoride varnish|Fluoride varnish will be administered by the COHS quarterly for 2 years.
16235946|NCT01116739|Behavioral|Oral health education|Oral health education will be provided quarterly for 2 years. It will include information about how to mitigate the known risk factors for early childhood dental caries.
16235947|NCT01116739|Other|Dental services delivered by the Indian Health Service.|
16235948|NCT01116726|Behavioral|Motivational interviewing|MI sessions will involve home visits concentrating on the mitigation of behavioral risk factors for early childhood caries. These will take place shortly after childbirth and at months 6, 12, and 18.
16235980|NCT01116466|Device|ActiGait|ActiGait - implantable drop foot stimulator
16235949|NCT01116726|Behavioral|Enhanced community services|Enhanced community services will involve the development of culturally appropriate messages related to the mitigation of behavioral risk factors for early childhood caries through public service announcements and brochures.
16235950|NCT01116713|Drug|intravenous dexamethasone|One dose of intravenous dexamethasone (8 mg) 60 minutes before skin incision.
16235951|NCT01116713|Drug|Homologated placebo.|Patients of the control group received homologated placebo 60 minutes before skin incision
16235952|NCT01116700|Drug|Dexmedetomidine|Dexmedetomidine will be administered to 2 groups: (1) Seizure disordered patients on anticonvulsants and (2) Healthy volunteers (Control group)
16235953|NCT01116687|Drug|gamma-secretase/Notch signalling pathway inhibitor RO4929097|Given orally
16235954|NCT01116687|Other|laboratory biomarker analysis|Correlative studies
16235955|NCT01116661|Drug|5-Aminolevuline Acid (ALA)|Given orally at a dose of 20 mg/kg body weight 3hrs before anesthesia prior to surgery
16235956|NCT01116648|Drug|Cediranib Maleate|Given PO
16235957|NCT01116648|Drug|Olaparib|Given PO
16235958|NCT01116635|Drug|doxorubicin, superabsorbent polymer microspheres, embolotherapy|varying doses of doxorubicin loaded onto SAP during embolization procedure. Pharmacokinetic analysis of elution profile through serum concentrations over 1 month period embolization of surgically resectable HCC with superabsorbent polymer microspheres loaded with doxorubicin from a single treatment. Phase I will follow a modified Fibonacci sequence (with pharmacokinetic analysis of serum doxorubicin) to determine mean tolerated dose (MTD), severe adverse reaction (SAE) and dose limiting toxicities (DLT) when microspheres are loaded with 25mg, 50mg, or 75mg of doxorubicin. Phase II will continue enrollment with the two highest tolerated doses. At least one month after treatment, all patients will undergo imaging and surgical resection of reference tumor, with assessment of degree of necrosis, microsphere distribution, and correlation with concentration of doxorubicin loaded onto microsphere.
16235959|NCT01116622|Drug|Bexarotene (Targretin®)|Level -I 200 mg/m2 Level I 300 mg/m2 Level II 300 mg/m2 Level III 400 mg/m2
16235960|NCT01116622|Drug|Erlotinib (Tarceva™)|Level -1 100mg Level I 100mg Level II 150mg Level III 150mg
16235961|NCT01116609|Drug|Epinephrine|unilateral leg infusion of Epinephrine 0.4 micrograms/m2/min
16235962|NCT01116596|Drug|Paracetamol|determine, in subjects aged over 70 years, the blood concentration of glutathione (GSH) and urinary loss of cysteine in the detoxification of paracetamol, when taking paracetamol treatment repeated.
16235963|NCT01116583|Drug|Gabapentin|"Preoperatively (2 hours before surgery): 4 gabapentin capsules each containing 300 mg gabapentin (total gabapentin dose 1200 mg)
~Postoperative day 1: gabapentin 300 mg x 2 (total gabapentin dose 600 mg)
~Postoperative day 2: gabapentin 300 mg x 3 (total gabapentin dose 900 mg)
~Postoperative day 3: gabapentin 300 mg x 4 (total gabapentin dose 1200 mg)
~Postoperative day 4: gabapentin 300 mg x 4 (total gabapentin dose 1200 mg)
~Postoperative day 5: gabapentin 300 mg x 4 (total gabapentin dose 1200 mg)"
16235964|NCT01116583|Drug|Placebo|"Preoperatively (2 hours before surgery): 4 placebo capsules
~Postoperative day 1: 1 placebo capsule x 2
~Postoperative day 2: 1 placebo capsule x 3
~Postoperative day 3: 1 placebo capsule x 4
~Postoperative day 4: 1 placebo capsule x 4
~Postoperative day 5: 1 placebo capsule x 4"
16235965|NCT01116570|Other|Physical training|Physical training during 24 weeks
16235966|NCT01116570|Other|Control|No intervention
16235967|NCT01116557|Device|Radiofrequency Ablation procedure|Radiofrequency Ablation procedure Application of radiofrequency energy with the THERMOCOOL® catheter used in combination with the CARTO® 3 System and the LASSO® Circular Mapping Catheter to eliminate potentials arising from the pulmonary veins.
16235968|NCT01116557|Device|Radiofrequency Ablation procedure|Application of radiofrequency energy with the Pulmonary Vein Ablation Catheter® (PVAC®) to eliminate potentials arising from the pulmonary veins.
16235969|NCT01116544|Device|AMES Therapy (assisted movement and enhanced sensation)|Each subject will receive 30 sessions of AMES therapy in the clinic. Each session will consist of 10 min of functional testing (i.e., passive motion and strength tests) followed by 30 min of grasp therapy using the AMES device. One group of subjects will receive AMES therapy only with joint torque biofeedback (without EMG feedback), and the other group will receive AMES therapy with EMG biofeedback. While all test subjects should attempt to open the hand when the grasp mechanism is opening and close the hand when the mechanism is closing, the biofeedback information provided to aid a subject will differ for the 2 subject groups.
16235970|NCT01116531|Drug|Tramadol|Initial dose of oral tramadol (depottabl Tramal retard, Orionpharma, Finland) will be 100mg once daily. If the subject is currently on opioid treatment with codeine, tramadol or buprenorphine, the opioid treatment will be stopped, and an equal dose of tramadol will be used as the initial dose. The dose will be titrated on visits V2 and V3 based on the adequacy of pain relief and tolerability. If pain intensity ≥ 4 on a numeric rating scale of 0-10 during V2 and V3 and tramadol is well tolerated, the daily dose will be increased by 100mg. The maximum daily dose of 400 mg tramadol will not be exceeded. If the subject does not tolerate the initial dose of tramadol, he/she will be dropped out of the study and replaced by another patient.
16235971|NCT01116531|Drug|Duloxetine|The initial dose of duloxetine (Cymbalta, Eli Lilly, USA) will be 30mg once daily. The dose will be titrated on V2 based on the adequacy of pain relief and tolerability. If pain intensity during V2 is < 4 on a scale of 0-10, the dose of duloxetine dose will be 30mg daily throughout the study. If pain intensity is ≥ 4 on a numeric rating scale of 0-10 and duloxetine is well tolerated, the daily dose will be increased to 60mg once daily. If the subject does not tolerate the initial dose of duloxetine, he/she will be dropped out of the study and replaced by another patient.
16235972|NCT01116531|Drug|Pregabalin|The initial dose of pregabalin (Lyrica, Pfizer, USA) will be 75mg twice a day. The dose will be titrated on V2 based on the adequacy of pain relief and tolerability. If pain intensity during V2 is < 4 on a scale of 0-10, the initial dose of pregabalin dose will be continued. If pain intensity is ≥ 4 on a numeric rating scale of 0-10 and pregabalin is well tolerated, the daily dose will be increased to 150mg twice a day. If the subject does not tolerate the initial dose of pregabalin, he/she will be dropped out of the study and replaced by another patient.
16235973|NCT01116518|Procedure|physiotherapy|
16235974|NCT01116518|Procedure|acromioplasty|
16235975|NCT01116518|Procedure|acromioplasty and rotator cuff reconstruction|
16235976|NCT01116505|Dietary Supplement|Gluten-free diet|gluten-containing cereals removed from diet
16235977|NCT01116492|Other|Single incision laparoscopic cholecystectomy|One port placed through the umbilicus
16235981|NCT01116453|Procedure|acupuncture|acupuncture on the acupoints of ST44 and ST43 of bilateral feet for 2 months, then followed-up for another 2months
16235982|NCT01116453|Procedure|usual care|usual care with medication and behavior therapy for 2 months, followed by acupuncture for additional 2 months
16235983|NCT01116440|Drug|BGS649|0.1 mg capsules for oral administration. A total dose of 3 capsules of BGS649 0.1mg will be administered at randomization, week 4, and week 8 at the study site.
16235984|NCT01116440|Drug|Placebo|Placebo matching BGS649 will be provided by Novartis as capsules for oral administration. Three capsules of placebo will be administered at randomization, week 4, and week 8 at the study site.
16235985|NCT01116427|Biological|abatacept|In core/extension phase: administered IV at weeks 0/28, 2/30, and 4/32, and then every 4 weeks until week 24/52; Dosing: less than 60 kg, 500 mg; 60-100 kg, 750 mg; or greater than 100 kg, 1 gram
16235986|NCT01116427|Drug|Placebo|In core/extension phase: administered IV at weeks 0/28, 2/30, and 4/32, and then every 4 weeks until week 24/52
16235987|NCT01116401|Drug|leuprolide|Leuprolide acetate is a widely used GnRH agonist. In this protocol, leuprolide will be administered at a dose routinely used for treatment of endometriosis and uterine fibroids in women (one 3.75-mg intramuscular injection).
16235988|NCT01116388|Other|GFCF product with GFCF diet|"Group I: will receive the test product (product free of gluten and casein) with GFCF Diet for the 1st 6-weeks.
~Group II: will receive the test product (product free of gluten and casein) with GFCF diet for the 2nd 6-weeks."
16235989|NCT01116388|Other|product containing gluten and casein (milk protein) with GFCF diet|"Group I: will receive the control product (product containing gluten and casein) with the GFCF diet for the 2nd 6-weeks.
~Group II: will receive the control product (product containing gluten and casein) with the GFCF diet for the 1st 6-weeks"
16235990|NCT01116362|Procedure|primary repair|during the first days,the nerve was conducted to repair as end to end (epi-epineurium, epi-epineurium) anastomosis. This was performed following the repair of present tendons and muscle injuries.
16235991|NCT01116362|Procedure|secondary repair|after one week,the nerve was conducted to repair as end to end (epi-epineurium, epi-epineurium) anastomosis. This was performed following the repair of present tendons and muscle injuries.
16235992|NCT01116349|Procedure|Plate and screws or nailing|Patients included in the surgical group will be divided into two subgroups according to the method of fixation chosen: plate and screws or nailing. Surgeries take place under general anesthesia and a prophylaxis antibiotic is administrated. The installation and the approach will be chosen by the surgeon according to his preferences. A thoraco brachial brace is placed on the patient at the end of the intervention and it remains in place for a period of 5 to 10 days (patient comfort). A gradual mobilization of the elbow and shoulder will be initiated by the patient at home. The addition of physical therapy will be decided by the surgeon and noted down accordingly.
16235993|NCT01116349|Device|Hanging Support System (HSS) brace|Patients included in the conservative group will be taken to a plaster room where the HSS brace will be installed by a qualified technician. Advice will be provided for the care, personal hygiene and clothing. The brace will be kept for a period of 6 to 12 weeks depending on the degree of healing of fracture. The maintenance of the proximal part (Brace) may be recommended by the surgeon. The mobilization will begin with exercises at home and whether the patient does physical therapy or not is the surgeon's choice.
16235994|NCT01116336|Drug|Erlotinib|Participants will be given erlotinib orally (dose escalation from 50 mg, 75 mg, or 100 mg daily continuously for 6 cycles (each cycle is 28 days).
16235995|NCT01116336|Dietary Supplement|Green Tea Polyphenon E|Participants will also be given PPE orally (200 mg EGCG) three times daily for 6 cycles (each cycle is 28 days). PPE capsules will be taken on a full stomach, within one hour after eating a substantial meal.
16235996|NCT01116310|Drug|Soy isoflavones (Glycine max L) and red clover extract (Trifolium pretense L)|Bottles containing 60 capsules, 53.5 mg/capsule of isoflavones
16235997|NCT01116310|Drug|Placebo|Bottles containing 60 capsules.
16235998|NCT01116297|Device|Imaging with S-FLARE imaging system|Tissue oxygenation measurements during plastic surgery using the S-FLARE system.
16235999|NCT01116284|Procedure|Revision of gastric bypass|A laparoscopic operation will be performed to decrease the size of the enlarged gastric outlet. Three 5-mm laparoscopic trocars will be placed in the upper abdomen and suture plication of the gastrojejunostomy on the medial, lateral and anterior surface of the anastomosis will be performed. The resulting anastomosis will be evaluated with intraoperative endoscopy and leak tested intraoperatively. The patients will be evaluated in the post-operative period and are expected to be discharged from the hospital within 24 hours.
16236000|NCT01116271|Drug|AZD6244|50 or 75mg, capsules, PO, BID, 28 days
16236001|NCT01116271|Drug|Irinotecan|180mg/m2, IV, Day 1& 15 of each cycle
16236002|NCT01116258|Drug|AZD5847|oral suspension, 15 days
16236003|NCT01116258|Drug|Placebo|oral suspension, 15 days
16236004|NCT01116245|Biological|ADXS11-001 (Lm-LLO-E7)|ADXS11-001 at one of three dose levels given as 3 vaccinations separated by 4 weeks with an oral antibiotic regimen subsequent to dosing.
16236005|NCT01116245|Drug|Placebo Control|3 intravenous infusions of normal saline at 28 day intervals. All infusions will be preceded by prophylactic NSAID and antihistamine, and followed 3d later with antibiotic.
16236006|NCT01116232|Biological|anti-thymocyte globulin|Infuse the first dose over a minimum of 6 hours, and subsequent doses over a minimum of 4 hours via a 0.22 micron in-line filter.
16236007|NCT01116232|Biological|rituximab|"The total dose chosen for this protocol is 28 mg/kg divided in two doses (14 mg/kg on days -7 and +3). Initial infusion: Start rate of 50 mg/hour; if there is no reaction, increase the rate by 50 mg/hour increments every 30 minutes, to a maximum rate of 400 mg/hour. Subsequent infusions: If patient did not tolerate initial infusion follow initial infusion guidelines. If patient tolerated initial infusion, start at 100 mg/hour; if there is no reaction, increase the rate by 100 mg/hour increments every 30 minutes, to a maximum rate of 400 mg/hour. Note: If a reaction occurs, slow or stop the infusion. If the reaction abates, restart infusion at 50% of the previous rate.
~In patients who tolerated the Rituximab well in the past, a rapid infusion rate can be used over 90 minutes with 20% of the dose administered in the first 30 minutes and the remaining 80% is given over 60 minutes."
16236008|NCT01116232|Drug|sirolimus|For adults, Sirolimus will be administered at 12 mg orally loading dose on day -3, followed by 4 mg orally single morning daily dose (target serum level 3-12 ng/ml by HPLC).
16238007|NCT01100801|Drug|TS-1 with oxaliplatin|
16236009|NCT01116232|Drug|tacrolimus|Tacrolimus will be administered intravenously at a dose of 0.03 mg/kg (ideal body weight) q 24h by continuous infusion starting on Day -3. Intravenous Tacrolimus will be discontinued once the patient starts eating and the drug will then be given orally at a dose of approximately 4 times the intravenous dose.
16236010|NCT01116232|Other|laboratory biomarker analysis|laboratory biomarker analysis
16236011|NCT01116232|Procedure|allogeneic hematopoietic stem cell transplantation|allogeneic hematopoietic stem cell transplantation
16236012|NCT01116232|Procedure|management of therapy complications|management of therapy complications
16236013|NCT01116232|Procedure|peripheral blood stem cell transplantation|peripheral blood stem cell transplantation
16236014|NCT01116219|Biological|bevacizumab, erlotinib|"Bevacizumab 7.5 mg/kg i.v. every 3 weeks and
~Erlotinib 150 mg p.o. daily until progression."
16236015|NCT01116219|Drug|bevacizumab, pemetrexed, cisplatin|"Induction chemotherapy with
~Bevacizumab 7.5 mg/kg i.v. and
~Pemetrexed 500 mg/m2 i.v. and
~Cisplatin* 75 mg/m2 i.v. every 3 weeks for a maximum of 4 cycles or until progression. Followed by maintenance therapy in patients without disease progression with
~Bevacizumab 7.5 mg/kg i.v. and
~Pemetrexed 500 mg/m2 i.v. every 3 weeks until progression."
16236016|NCT01116206|Drug|Prucalopride|2 mg tablet, orally once daily, for 12 weeks
16236017|NCT01116206|Drug|Placebo|1 tablet, orally once dailyfor 12 weeks
16236018|NCT01116193|Drug|Lenalidomide plus dexamethasone|Lenalidomide 25 mg p.o. once daily on days 1-21 plus Dexamethasone 40 mg p.o. once daily on days 1, 8, 15, and 22 of each 28-day cycle (4-weeks cycles) until CR achievement, progression of disease or intolerable toxicity
16236019|NCT01116180|Drug|Angiotensin II receptor antagonists (Candesartan)|Seven days of treatment with Candesartan 32 mg, capsules.
16236020|NCT01116180|Drug|Placebo|Placebo Capsule matching the active comparator. Given for 7 days once daily.
16236021|NCT01116167|Drug|Letrozole -Berberine|"Letrozole
~2.5 mg letrozole daily from day 5 of the menses for 5 days for month 1 to 3, 5.0 mg letrozole daily from day 5 of the menses for 5 days for month 4 to 6.
~Berberine
~1.5g daily for 6 month."
16236022|NCT01116167|Drug|Letrozole|"Letrozole
~2.5 mg letrozole daily from day 5 of the menses for 5 days for month 1 to 3, 5.0 mg letrozole daily from day 5 of the menses for 5 days for month 4 to 6.
~Berberine Placebo
~5 tablet tds for 6 months"
16236023|NCT01116167|Drug|Berberine|"Berberine
~1.5g daily for 6 month.
~Letrozole placebo
~1 tablet daily from day 5 of the menses for 5 days for month 1 to 3, 2 tablets daily from day 5 of the menses for 5 days for month 4 to 6."
16236024|NCT01116154|Drug|lenalidomide|Given orally
16236025|NCT01116154|Drug|vorinostat|Given orally
16236026|NCT01116154|Other|laboratory biomarker analysis|Correlative studies
16236027|NCT01116141|Drug|CH-4051|Different doses CH-4051 to be compared
16236028|NCT01116141|Drug|Methotrexate (MTX)|20 mg MTX weekly
16236029|NCT01116141|Drug|Folic Acid|1 mg folic acid daily
16236030|NCT01116128|Drug|dasatinib|100 mg QD continuously (from day 1 to day 28)
16236031|NCT01116128|Drug|melphalan|0,18 mg/Kg/day from day 1 to day 4 for 6 cycles
16236032|NCT01116128|Drug|prednisone|1,5 mg/Kg/day from day 1 to day 4 for 6 cycles
16236033|NCT01116115|Other|InFat™ based infant formula|High sn-2 palmitic acid oil based infant formula
16236034|NCT01116115|Other|Standard vegetable oil based infant formula|Standard vegetable oil based infant formula
16236035|NCT01116102|Drug|Subcutaneous HYLENEX (recombinant human hyaluronidase) and Lactated Ringer's solution|Subcutaneous administration of 150 U HYLENEX, followed by 1000 mL Lactated Ringer's solution
16236036|NCT01116089|Drug|Bramitob® administered by PARI LC® PLUS nebulizer|(tobramycin 300mg /4mL) solution administered by inhalation twice daily for 28 days
16236037|NCT01116089|Drug|Bramitob® administered by PARI eFlow® rapid electronic nebulizer|(tobramycin 300mg /4mL) solution administered by inhalation twice daily for 28 days
16236038|NCT01116076|Behavioral|Decision+ program (to improve optimal drug prescription for ARI)|DECISION+ is a multifaceted intervention program that includes: On site course and Internet-based courses (2x120 min), reminders of expected behaviours and feedback.
16236039|NCT01116063|Drug|Inhaled iloprost|Inhalation Initial: 2.5 mcg/dose; if tolerated, increase to 5 mcg/dose; administer 6 times daily
16236040|NCT01116050|Drug|Misoprostol|5 tablets of 200 microgram geach intra rectal by opaque introducer
16236041|NCT01116050|Drug|Placebo|5 tablets in opque introducer
16236042|NCT01116037|Device|ATS 3f Aortic Bioprosthesis|Equine Pericardial Bioprosthesis for replacement of diseased valve
16236043|NCT01116024|Device|ATS 3f Enable Aortic Bioprosthesis Model 6000|Replacement Aortic Heart Valve
16236044|NCT01116011|Drug|AZD7268|Capsule, Oral, BID
16236045|NCT01116011|Drug|Placebo|Capsule, Oral, BID
16236046|NCT01115998|Other|Power wheelchair|Children used power wheelchairs for one year. They continued to receive their usual early intervention services.
16236047|NCT01115998|Other|No power wheelchairs|Children in the control group did not use power wheelchairs. They continued to receive their usual early intervention services.
16236048|NCT01115985|Drug|ASP1585|oral
16236049|NCT01115985|Drug|atorvastatin|oral
16236050|NCT01115972|Drug|ASP1585|oral
16236051|NCT01115972|Drug|valsartan|oral
16236052|NCT01115959|Drug|valproic acid|treatment of 1 month dosage of 400 mg BID
16236053|NCT01115959|Drug|placebo bid|
16236054|NCT01115946|Drug|ASP1585|oral
16236055|NCT01115946|Drug|enalapril|oral
16236056|NCT01115933|Device|XIENCE PRIME SV EECSS|Patients receiving XIENCE PRIME SV EECSS
16236057|NCT01115920|Drug|MTP-131 (Bendavia™)|Single 4 hour intravenous infusion
16236058|NCT01115907|Device|Freedom SOLO Stentless Heart Valve|Freedom SOLO Stentless Heart Valve
16236059|NCT01115894|Drug|Naltrexone|100 mg oral dosage daily for 12 weeks
16236060|NCT01115894|Behavioral|Modified Behavioral Self-Control Psychotherapy|Moderation- and cognitive-behaviorally-based psychotherapy. Treatment goal of moderation of alcohol consumption. 12 weekly, 1-hour sessions.
16236061|NCT01115894|Behavioral|Brief Behavioral Compliance Enhancement Therapy|Brief supportive counseling to enhance compliance with medication and encourage goal-setting concerning alcohol consumption.
16236062|NCT01115894|Drug|Placebo|Placebo
16236063|NCT01115868|Drug|Prevascar 5ng|100uL of 5ng/100uL Prevascar per linear centimetre wound margin injected intradermally.
16236064|NCT01115868|Drug|Prevascar 25ng|• 100uL of 25ng/100uL Prevascar per linear centimetre wound margin injected intradermally.
16236065|NCT01115868|Drug|Prevascar 100ng|• 100uL of 100ng/100uL Prevascar per linear centimetre wound margin injected intradermally.
16236066|NCT01115868|Drug|Prevascar 250ng|• 100uL of 250ng/100uL Prevascar per linear centimetre wound margin injected intradermally.
16236067|NCT01115855|Drug|Eplerenone|Eplerenone 25 mg once every other day, 25mg once daily or 50 mg once daily
16236068|NCT01115855|Drug|Placebo|Placebo once daily or every once daily
16236069|NCT01115842|Drug|Vitamin D|Vitamin D 4000IU per day for 5 days
16236070|NCT01115803|Drug|LY2584702|Supplied as 25 milligrams (mg) and 100 mg capsules, administered orally for two 28-day cycles.
16236071|NCT01115803|Drug|Erlotinib|"Supplied as 25 mg, 100 mg, or 150 mg tablets, administered orally, daily for two 28-day cycles.
~Starting dose is 150mg. Doses may be decreased in 50mg increments if necessary due to toxicity."
16236072|NCT01115803|Drug|Everolimus|Supplied as 5 mg or 10 mg tablets, administered orally, daily for two 28-day cycles.
16236073|NCT01115790|Drug|Prexasertib|Prexasertib IV on day 1 of a 14 day cycle. The expected duration is 3 cycles (2 weeks each for a total of 6 weeks). Participants receiving clinical benefit may remain on study until disease progression, unacceptable toxicity or other criteria for discontinuation are met.
16236074|NCT01115777|Other|Quality of Life surveys completed at specified timepoints|Quality of Life surveys (no treatment)
16236075|NCT01115751|Drug|LY2780301|"Administered orally, daily for two 28-day cycles.
~Starting dose is 100mg. The dose will be subsequently increased to 200mg, 300mg, 400mg, 500mg, and 600mg if no dose limiting toxicity is observed at the prior dose levels. Patients who, in the opinion of the investigator, demonstrate clinical benefit may receive treatment beyond two cycles until disease progression."
16236076|NCT01115738|Drug|Prasugrel|Loading dose administered once orally and maintenance dose administered orally 24 hours after loading dose, then every 24 hours for 72 hours.
16236077|NCT01115738|Drug|Clopidogrel|Loading dose administered once orally.
16236078|NCT01115738|Drug|Placebo|Loading dose administered once orally
16236079|NCT01115725|Drug|Gonal-f® (follitropin alfa)|Gonal-f® (follitropin alfa) will be given once daily subcutaneously at a starting dose of 150-375 international unit per day (IU/day) by self-administered injection via a pen device for first 5 days. After Day 5, Gonal-f® dose will be adjusted according to the investigator's discretion until ovarian response observed.
16236080|NCT01115712|Drug|Placebo|Placebo (to match pioglitazone 30 mg) once daily
16236081|NCT01115712|Drug|Comparator: Pioglitazone|Pioglitazone 30 mg once daily
16236082|NCT01115712|Drug|Comparator: Hyperinsulinemic Euglycemic Clamp|Infusion of Glucose (20% dextrose) to achieve a glucose concentration of 90mg/dL; Infusion of Insulin at a rate of 10 mU/m2/minute from 0 to 180 minutes and at a rate of 40 mU/m2/minute from 180 to 360 minutes; Saline infusion at 60 minutes before the insulin and glucose infusions to keep the antecubital vein open.
16236083|NCT01115699|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|Active 10 Hz rTMS will be applied to the left dorsolateral prefrontal cortex (L-DLPFC) with an intensity of 120% motor threshold. The L-DLPFC location is defined as that area 5 cm anterior to the motor cortex for activation of abductor pollicis brevis. Subjects will receive a total of 3000 stimuli per session. The TMS trains are 4 seconds on and 26 seconds off for a total of 37 1/2 minutes. Treatment will occur 5 days per week for up to six weeks. Subjects will be monitored during rTMS for any side effects or adverse events.
16236084|NCT01115686|Drug|Branched-chain aminoacids|"Branched-chain aminoacids will be orally administered in the form of capsules, at the rate of a capsule for physical 7 Kilograms weighty and a day. Every capsule containing 375 milligrams of branched-chain aminoacids.
~The treatment will last 3 weeks."
16236085|NCT01115686|Drug|Placebo|"Placebo will be orally administered in the form of capsules, at the rate of a capsule for physical 7 Kilograms weighty and a day.
~The treatment will last 3 weeks."
16236086|NCT01115673|Drug|Acetaminophen|Acetaminophen Caplet - single dose
16236087|NCT01115673|Drug|Placebo Control|0 mg Caplet - single dose
16236088|NCT01115660|Behavioral|stroke education|call by medication coach 2 weeks after hospital discharge
16236089|NCT01115647|Dietary Supplement|Ready-to-Use Therapeutic Food (RUTF)|A Ready-to-Use Therapeutic Food (RUTF), locally produced in Burkina Faso. The RUSF will be nutritionally characterized by chemical analysis (macronutrients, amino acids, vitamins A, C, D, E, B12, thiamin, riboflavin, niacin, calcium, iron, zinc, copper, selenium) and will be analyzed for macronutrients and energy density. All analysis methods are either based on the Official Methods of Analysis of AOAC International or in-house validated analytical methods. The pilot production phase and Hazard Analysis of Critical Control Points (HACCP) risk inventory of the production process will be performed by a food technologist from the Department of Food safety and Food quality, Ghent University.
16236090|NCT01115647|Dietary Supplement|CBS++|CSB is a low-cost combination of a cereal and a legume sometimes fortified with micronutrients. However, it presents shortcomings such as too many anti-nutrients, suboptimal micronutrient content, high bulk and viscosity. The World Food Program has recently proposed an enhanced CSB, named CSB++, which is prepared from heat treated maize and de-hulled soya beans, sugar, dried skim milk, refined soya bean oil, vitamins and minerals.
16236091|NCT01115647|Behavioral|CCC|Child-Centred dietary Counselling (CCC). Although educational/behavioral interventions can be effective to improve child growth, there is little evidence of their effectiveness for MAM. Moreover, evidence from Africa is inexistent. Currently, the main management of MAM consists of giving nutritional advice to the caretakers, but mothers of MAM children are given the same general dietary advice as mothers of well-nourished children. A more efficient, child-centred approach is therefore proposed, by adapting the counselling to the needs of the family, developing a more child-centred approach, by providing operational recommendations for MAM children and providing an adequate follow-up post-treatment.
16236092|NCT01115634|Biological|Fibroblast|20 million cell in three injection
16236093|NCT01115634|Biological|fibroblast and gel|20 million cell in three injection plus filler
16236094|NCT01115621|Other|Glutenfree diet during the first year of life|Glutenfree diet during the first year of life
16236095|NCT01115608|Other|Pharmacist follow-up|Drug review, drug conversation and written drug information. Follow-up concerning therapeutic goals and cooperation with the patient and the patient's GP to achieve these.
16236096|NCT01115595|Biological|Intervention|Dermatophagoides pteronyssinus from ALK company
16236097|NCT01115595|Other|Control|Injection by buffer solution WITH standard allergic medication (oral antihistamine and/or topical nasal steroid)
16236098|NCT01115582|Drug|Cholic acid|"The IUPAC name for cholic acid is 3 alpha,7alpha,12 alpha-trihydroxy-5 beta-cholanoic acid. The international nonproprietary name (INN) is cholic acid.
~Each patient will be given a box containing a 1 month supply of study drug. Each bottle will contain 90 capsules; each capsule will contain either 50 or 250 mg of manufactured cholic acid depending upon the child's weight. The study drug will be taken orally, in divided doses (as determined by the investigator), for a total daily dose of 10-15 mg/kg body weight. Parents of infants and young children who are unable to swallow the TBM cholic acid capsule will be instructed to sprinkle the contents of the capsule over 1-2 teaspoons of plain applesauce and feed it to the child."
16236099|NCT01115569|Drug|Hydrocodone Bitartrate|Open-Label, Capsule Strengths 10 mg, 20 mg, 30 mg, 40 mg, 50 mg; by mouth (PO) twice a day (BID) for up to 48 weeks
16236100|NCT01115556|Drug|Ranibizumab|2.0 mg
16236101|NCT01115556|Drug|Ranibizumab|0.5 mg
16236102|NCT01115543|Drug|alfacalcidol and calcitriol|The initial dose of alfacalcidol was twice that of calcitriol.Both were adjusted to control intact PTH within the ranges of 150-300 pg/ml.
16236103|NCT01115530|Other|Resistance exercise|Lower extremity resistance exercise (leg press/knee extension) twice per week for 12 weeks
16236104|NCT01115530|Dietary Supplement|Protein and HMB (see below) supplement|Ingested twice daily for 12 weeks Active components include: Protein and B-hydroxy-B -methylbutyrate
16236105|NCT01115517|Drug|Bevacizumab|1.25 mg/mL applied one time intraoperatively using bevacizumab-soaked filter paper manually applied to bare sclera during pterygium surgery for 2 minutes, followed by copious rinsing with balanced salt solution.
16236106|NCT01115517|Drug|Mitomycin C|Mitomycin C 0.02% will be applied to bare sclera during pterygium surgery using a medication-soaked filter paper for a duration of two minutes. After medication administration, the ocular surface will be copiously irrigated with balanced salt solution.
16236107|NCT01115504|Drug|Thiamine|300 mg daily for 30 days
16236108|NCT01115491|Drug|bevacizumab [Avastin]|Bevacizumab 10 mg/kg body weight will be administered intravenously every two weeks
16236109|NCT01115491|Drug|temozolomide|Daily by the oral route (dose, 150 mg/m2) on days 1 to 7 and 15 to 21 of each cycle
16236110|NCT01115478|Dietary Supplement|Vitamin A|Daily oral dose of 2500 IU from enrollment until delivery
16236111|NCT01115478|Dietary Supplement|Zinc|Daily oral dose of 25 mg from enrollment until delivery
16236112|NCT01115478|Other|Placebo|Daily oral dose from enrollment until delivery
16236113|NCT01115465|Device|Macroplastique|Macroplastique is an injectable soft-tissue bulking agent used to treat stress urinary incontinence (SUI) primarily due to intrinsic sphincter deficiency (ISD).
16236114|NCT01115452|Drug|5% Potassium nitrate|5% potassium nitrate solution
16236115|NCT01115452|Drug|2.5% Potassium nitrate|2.5% potassium nitrate solution
16236116|NCT01115452|Other|Sterile water|Sterile water
16236117|NCT01115439|Drug|artesunate plus sulfadoxine-pyrimethamine (AS+SP)|artesunate plus sulfadoxine-pyrimethamine (AS+SP)
16236118|NCT01115426|Drug|Ramipril or losartan|Ramipril (5 mg/day) was started soon after the enrollment and continued throughout the follow-up, having Losartan (50 mg/day) as alternative.
16236119|NCT01115387|Other|Observational-1|"Multiple questionnaires detailing family history, medical history, visual symptoms, smoking, environmental and dietary exposures.
~Prospective photography of the retina to detect early ARM-related changes A saliva or blood sample for genetic testing."
16236120|NCT01115387|Other|Observational-2|"A limited number of questionnaires and prior clinical documentation from eye care professionals of eye status with respect to ARM.
~No prospective retina photographs but ongoing follow-up for reported changes in ARM status.
~A saliva or blood sample for genetic testing."
16236121|NCT01115374|Procedure|Manual lymphatic drainage|Application of manual lymphatic drainage (one session every work day during two weeks, total 10 sessions)
16236122|NCT01115374|Device|low frequency sound waves|Application of low frequency sound waves (one session every work day during two weeks, total 10 sessions)
16236123|NCT01115361|Behavioral|Family planning for postpartum women|"A.Group education sessions regarding pregnancy risk, benefits of FP, and family planning options during the postpartum period.
~B. IEC materials that deliver messages about the benefits of spacing pregnancies by at least 2 years, LAM, return to fecundity and pregnancy risk during the postpartum period and contraceptive options for postpartum women.
~C. Use of a screening tool to assess pregnancy risk for postpartum women coupled with a brief counseling message and referral to FP services.
~D.Convenient offer of FP services to women attending vaccination services for their infants."
16236124|NCT01115335|Procedure|Neonatal male circumcision|Circumcision performed on a male infant within the first month of life, using one of 3 devices
16236125|NCT01115322|Drug|Tazarotene Foam without irradiation|"Each subject will be exposed to a patch with tazarotene foam during a single, 24 hour application period.
~This patch will then be removed and those sites will serve as nonirradiated control. Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal."
16236126|NCT01115322|Drug|Tazarotene Foam with UVA and UVB irradiation|"Each subject will be exposed to a patch with tazarotene foam during a single, 24 hour application period. The patch will be removed and that site will be exposed to ultraviolet A (UVA) and to UVA/ultraviolet B (UVB) radiation wavelengths (UV only).
~Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal."
16236127|NCT01115322|Drug|Tazarotene Foam with UVA, UVB, and visible light|"Each subject will be exposed to a patch with tazarotene foam during a single, 24 hour application period. The patch will be removed and that site will be exposed to UVA, UVA/UVB, and visible light (VIS) wavelengths (UV plus VIS).
~Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal."
16236156|NCT01115140|Drug|placebo plus folic acid|Placebo 1 cp daily plus folic acid 0.4 mg daily
16236157|NCT01115140|Drug|placebo alone|placebo cp, 2 cps daily
16239416|NCT01090466|Other|pharmacological study|
16236128|NCT01115322|Drug|Vehicle Foam without irradiation|Each subject will be exposed to a patch with vehicle foam during a single, 24 hour application period. This patch will then be removed and those sites will serve as nonirradiated control. Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.
16236129|NCT01115322|Drug|Vehicle Foam with UVA and UVB irradiation|"Each subject will be exposed to a patch with vehicle foam during a single, 24 hour application period. The patch will be removed and that site will be exposed to ultraviolet A (UVA) and to UVA/ultraviolet B (UVB) radiation wavelengths (UV only).
~Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal."
16236130|NCT01115322|Drug|Vehicle Foam with UVA and UVB and visible light irradiation|"Each subject will be exposed to a patch with vehicle foam during a single, 24 hour application period. The patch will be removed and that site will be exposed to UVA, UVA/UVB, and visible light (VIS) wavelengths (UV plus VIS).
~Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal."
16236131|NCT01115322|Drug|No Treatment without irradiation|Each subject will be exposed to a blank patch during a single, 24 hour application period. This patch will then be removed and those sites will serve as nonirradiated control. Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.
16236132|NCT01115322|Drug|No Treatment with UVA and UVB irradiation|"Each subject will be exposed to a blank patch during a single, 24 hour application period. The patch will be removed and that site will be exposed to ultraviolet A (UVA) and to UVA/ultraviolet B (UVB) radiation wavelengths (UV only).
~Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal."
16236133|NCT01115322|Drug|No Treatment with UVA and UVB and visible light irradiation|"Each subject will be exposed to a blank patch during a single, 24 hour application period. The patch will be removed and that site will be exposed to UVA, UVA/UVB, and visible light (VIS) wavelengths (UV plus VIS).
~Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal."
16236134|NCT01115309|Device|XprESS Balloon Device|Sinus dilation completed with the XprESS Balloon Device with or without additional endoscopic sinus surgery procedures (dilation of the frontal recesses, maxillary ostia, and/or sphenoid sinus ostia).
16236135|NCT01115296|Dietary Supplement|L. reuteri DSM 17938 and ATCC PTA 6475|L. reuteri dose of 1x108 CFU.
16236136|NCT01115296|Other|Placebo|Placebo
16236137|NCT01115283|Behavioral|Perceptual learning|Research participants will be asked to practice a visual discrimination task (e.g. position acuity, contrast sensitivity, stereoacuity etc) in our laboratory for a period of time (2 hrs/day, 5 days/week).
16236138|NCT01115283|Behavioral|Video Games|"Research participants will be asked to play off-the-shelf video games in our laboratory for a period of time (2 hrs/day, 5 days/week)."
16236139|NCT01115283|Behavioral|Occlusion therapy|Research participants will be required to cover the good eye during the day in order to push the brain to use the amblyopic eye (2 hrs/day, 5 days/week for 2-4 weeks).
16236140|NCT01115270|Other|Non-invasive measures|assessment of cerebrovascular fluid movement
16236141|NCT01115257|Procedure|vitrectomy|The surgical technique (Group 1) included vitrectomy, with a combination of delamination and segmentation of gliotic tractional membranes using bimanual technique. Silicone oil tamponade was used in eyes with long-standing tractional retinal detachment, as deemed necessary by the surgeon, or in eyes in which a retinal break occurred during the vitrectomy.
16236142|NCT01115257|Procedure|panretinalphotocoagulation|Panretinal photocoagulation was completed according to guidelines summarized in ETDRS with extensive full subconfluent panretinal photocoagulation.
16236143|NCT01115244|Drug|Dapsone gel, 5%|ACZONE™ (dapsone) Gel, 5% will be applied to one elbow or knee, randomized at time of enrollment. Application will be topical to the same location twice daily (morning and evening) for six weeks.
16236144|NCT01115218|Procedure|Trabeculectomy|Trabeculectomy with mitomycin C
16236145|NCT01115205|Behavioral|Supervised walking|Walk training, 3 sessions per week for 4 months, under the supervision of a qualified personal trainer.
16236146|NCT01115205|Behavioral|Standard counselling procedure|Verbal and written information about the benefits of exercise and instructions aimed to encourage physical activity. In addition, one group session of counselling on these issues.
16236147|NCT01115192|Procedure|Group A|Blephacura is a solution with liposomes and used for cleaning of the eye lid to treat blepharitis
16236148|NCT01115192|Procedure|Group B|Diluted Baby Shampoo is used for cleaning of the eye lid to treat blepharitis
16236149|NCT01115179|Drug|propofol|Induction with propofol (1.5 to 2mg/kg) and maintenance of anesthesia with propofol 1% (target controlled infusion with concentration levels of 3-5 ug/ml)
16236150|NCT01115179|Drug|Intralipid 10%|Induction of anesthesia with thiopental (3-5mg/kg) and maintenance of anesthesia with isoflurane (end-expired concentration = 0.5%-2.0%) as well as the solvent of propofol 1% (Intralipid 10%; corresponding to a target-controlled infusion of propofol with concentration levels of 3-5ug/ml)
16236151|NCT01115179|Drug|Saline|Induction of anesthesia with thiopental (3-5mg/kg) and maintenance of anesthesia with isoflurane (end-expired concentration = 0.5%-2.0%)
16236152|NCT01115153|Other|prophylaxis|single doses of antibiotics before surgery in patients with gangrenous appendicitis Metronidazole 500 mg IV + amikacin 1 gr IV
16236153|NCT01115153|Other|therapy|antibiotic treatment (5 days) therapy in patients with gangrenous appendicitis metronidazole 500 mg IV three times a day + amikacin 1 gr IV per day
16236154|NCT01115140|Drug|metformin plus placebo|metformin 850 mg cp, 2 cps daily
16236155|NCT01115140|Drug|Metformin plus folic acid|metformin 850 mg cp, 2 cps daily plus folic acid 0.4 mg daily
16236158|NCT01115127|Dietary Supplement|melatonin|30 subjects will take 1 tablet per day (at night-time) containing 3 grams of melatonin for 6 months
16236159|NCT01115127|Dietary Supplement|myo-inositol|30 subjects will take 2 tablets per day containing 2 grams of myo-inositol, for 6 months.
16236160|NCT01115127|Dietary Supplement|melatonin plus myo-inositol|30 subjects will take 2 grams per day of myo-inositol and 3 grams of melatonin at night-time for 6 months
16236161|NCT01115114|Behavioral|TAU|A medical assistant will provide feedback on and educational materials describing the meaning of lab values to individuals identified as needing follow-up for metabolic syndrome, and will provide educational materials regarding healthy eating and exercise. The psychiatrist will recommend that the individual contact a primary care physician to follow-up on out of range values, and alter behaviors (over eating, being sedentary) to help improve health.
16236162|NCT01115114|Behavioral|IMBED|After identifying individuals through routine screening that need medical follow-up for metabolic syndrome, these individuals will be scheduled to see the on site primary care provider. Rapid scheduling (within 2 weeks) will be attempted. Patients will be seen by the primary care provider monthly or as needed as determined per patient. The primary care provider will prescribe medications for metabolic syndrome, discuss the patient with psychiatry staff and recommend follow-up appointments for physical problems based upon recommended guidelines and clinical judgment of necessity and urgency. Referral to a specialist will be made according to standard primary care practice guidelines. During the Metabolic Syndrome Clinic, if individuals bring up other medical conditions, they will be referred for treatment of these conditions to an outside primary care provider.
16236163|NCT01115114|Behavioral|Liaison|Patients will be seen by the MCM bi-weekly or as needed as determined per patient. The MCM will discuss findings of the labs with the patient, work to get the individual an appointment with a primary care doctor, get releases of information to discuss treatment coordination between the primary care and psychiatric teams, obtain necessary records from primary care, and communicate findings to the treating psychiatrist. The MCM will also assist the patient in getting to primary care appointments by providing bus passes or other transportation, and with obtaining medications prescribed by the primary care provider. This may necessitate enrolling the patient in specific care plans as needed.
16236164|NCT01115101|Drug|Oral Oxycodon|Patients assigned to the oral analgesia group received 20mg oxycodon at fixed intervals: 2 hours (h) and between 12h and 14h after cesarean.
16236165|NCT01115101|Drug|Piritramid|"Patients assigned to the PCA group received a single use intravenous PCA device (Vygon, Medical Products, Aachen, Germany) with a 30ml deposit of 9% sodium chloride solution containing 60mg piritramide. Bolus injection of 0.5ml was administered by the patient herself if needed, with a lock out interval of 5 minutes
~Patients assigned to the oral analgesia group received 20mg oxycodon at fixed intervals: 2 hours (h) and between 12h and 14h after cesarean. The PCA was discontinued after 24 hours or earlier if demanded."
16236166|NCT01115088|Dietary Supplement|Aspartame|The morning breakfast after a 12-h fast and consumed a standard 469 kcal breakfast consisting of cereal, milk, toast with butter, and orange juice. Tea and crackers with cream cheese sweetened with stevia Whole Foods 365 Brand, aspartame equal sweetener, or sucrose participants consumed this preload 20 min before their test lunch and dinner meals. The Test lunch meal consisted of sandwiches, potato chips, and cookies, and the test dinner meal was a self-selected buffet-type meal (I.e., Macronutrient Self-Selection Paradigm) Geiselman et al,. 1998)
16236167|NCT01115088|Dietary Supplement|Sucrose|The morning breakfast after a 12-h fast and consumed a standard 469 kcal breakfast consisting of cereal, milk, toast with butter, and orange juice. Tea and crackers with cream cheese sweetened with stevia Whole Foods 365 Brand, aspartame equal sweetener, or sucrose participants consumed this preload 20 min before their test lunch and dinner meals. The Test lunch meal consisted of sandwiches, potato chips, and cookies, and the test dinner meal was a self-selected buffet-type meal (I.e., Macronutrient Self-Selection Paradigm) Geiselman et al,. 1998)
16236168|NCT01115088|Dietary Supplement|Stevia|The morning breakfast after a 12-h fast and consumed a standard 469 kcal breakfast consisting of cereal, milk, toast with butter, and orange juice. Tea and crackers with cream cheese sweetened with stevia Whole Foods 365 Brand, aspartame equal sweetener, or sucrose participants consumed this preload 20 min before their test lunch and dinner meals. The Test lunch meal consisted of sandwiches, potato chips, and cookies, and the test dinner meal was a self-selected buffet-type meal (I.e., Macronutrient Self-Selection Paradigm) Geiselman et al,. 1998)
16236169|NCT01115075|Other|Dietary fat/intake of carbohydrate|Spontaneous intake of fat, carbohydrate, protein and alcohol each day for 17 days.
16236170|NCT01115075|Behavioral|Spontaneous oscillations of dietary fat/intake of carbohydrate in relation to energy intake.|Dietitians and senior level or graduate level dietetics students who are not restrained eaters to participate in food intake over 17 days. During this same time interval, integrated energy expenditure will be recorded using doubly-labeled water and day to day energy expenditure by accelerometer. Periodic blood sampling for leptin will be done completed at site intervals.
16236171|NCT01115062|Drug|Synera Patch|Synera Patch (lidocaine 70 mg/ tetracaine 70 mg) will be applied for 30 minutes to the venipuncture site
16236172|NCT01115062|Drug|LMX 4 Cream|LMX 4 (4% liposomal lidocaine) cream (2g) will be applied under Tegaderm for 30 minutes to the venipuncture site.
16236173|NCT01115062|Drug|Placebo Patch|A placebo patch with the same properties as the Synera patch but without lidocaine/tetracaine will be administered for 30 minutes to the venipuncture site.
16236174|NCT01115049|Drug|chlorobutanol, hexetidine|3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash
16236175|NCT01115049|Drug|Chlorhexidine|3 times per day (after breakfast, lunch and dinner) for 1 minute with 15 ml of mouthwash
16236176|NCT01115036|Drug|panobinostat|Oral panobinostat will be administered at 20mg by mouth 3 times a week one week prior to surgical resection. Within 2-6 weeks of resection, patients will resume panobinostat at 20mg 3 times per week. A cycle will be 28 days.
16236177|NCT01115023|Other|iron cooking pot|the mother was instructed to cook the family food in the iron cooking pot for the study period (60 days) as frequently in the day as possible.
16236212|NCT01114698|Drug|Venlafaxine XR|Venlafaxine XR 75 mg/day administered orally once daily as 2 capsules identical in appearance to JNJ26489112 during the first week increased to 150 mg/day during weeks 2 through 6.
16236213|NCT01114698|Drug|Placebo|Placebo: 2 capsules identical in appearance to JNJ26489112 and venlafaxine XR orally administered once daily for 6 weeks.
16239418|NCT01090453|Biological|Prevenar 13®|3 co-administered doses
16236178|NCT01115010|Device|Colonoscope stiffening device|"Colonoscopy is performed with the unassisted colonoscope (Olympus CF-100TL). The standard stiffening wire is introduced only if there is difficulty advancing the colonoscope and only after the tip has passed the splenic flexure. Difficulty is defined as failure to advance the tip of the scope after 5 minutes of trying. If difficulty is again encountered, the firm wire replaces the standard wire. Further difficulty requires removal of the firm wire and so on until cecal intubation is achieved or the procedure is abandoned."
16236179|NCT01115010|Device|Colonoscope stiffening device|"Standard stiffening wire introduced routinely on entry into transverse colon. If difficulty is encountered (as defined previously), the standard wire is removed and attempts made to advance the colonoscope without it. Further difficulty requires introduction of the firm wire and so on until cecal intubation is achieved or the procedure is abandoned."
16236180|NCT01115010|Device|Colonoscope stiffening device|"Firm stiffening wire introduced routinely on entry into transverse colon. If difficulty is encountered (as defined previously), the wire is removed and attempts made to advance the colonoscope without it. Further difficulty requires introduction of the standard wire and so on until cecal intubation is achieved or the procedure is abandoned."
16236181|NCT01114997|Drug|Lidocaine|Pre-Induction: Lidocaine Loading: 1 mg/kg After Induction:Lidocaine Infusion: 12.5-25 mcg/kg/min 0.75-1.5 mg/kg/h)
16236182|NCT01114997|Drug|Esmolol|Esmolol Pre-Induction: Loading dose 750 mcg/Kg (0.75 mg/kg) Esmolol Post Induction: Infusion dose 7.5 - 15 mcg /kg/min
16236183|NCT01114997|Drug|Lidocaine + Esmolol (Combo)|"Pre-induction: Lidocaine Loading dose(1 mg/kg) + Esmolol Loading dose(750 mcg/Kg)
~Maintenance Infusion rate after Induction:
~Lidocaine(12.5-25 mcg/kg/min) + Esmolol(7.5-15 mcg/kg/min)"
16236184|NCT01114971|Drug|Fentanyl|"Fentanyl 50 micrograms/ml boluses will be given:
~at the induction time
~at the time before surgical incision, and
~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)"
16236185|NCT01114971|Drug|Labetalol|"Labetalol 5 mg/ml boluses will be given:
~at the induction time
~at the time before surgical incision, and
~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)"
16236186|NCT01114971|Drug|Esmolol|"Esmolol 10 mg/ml boluses will be given:
~at the induction time
~at the time before surgical incision, and
~as needed to maintain hemodynamic stability during the intraoperative period (MAP within 15% of the pre-induction baseline value, and/or HR > 80 bpm)"
16236187|NCT01114958|Drug|Cisplatin, Thiosulfate|Cisplatin (150 mg/m^2) is given as an intra-arterial bolus, once, on days 2 and 9 of treatment. Thiosulfate (9 g/m^2), is given concurrently with cisplatin as an intravenous push over 15-20 minutes followed by a 6-hour intravenous infusion of thiosulfate (12 g/m^2).
16236188|NCT01114945|Device|McGrath|Intubation with the McGrath device
16236189|NCT01114945|Device|GlideScope|Intubation with the GlideScope device
16236190|NCT01114945|Device|Direct Macintosh Laryngoscopy|Intubation with Direct Macintosh Laryngoscope
16236191|NCT01114945|Device|Video-Mac|Intubation with the Video-Mac device
16236192|NCT01114919|Behavioral|Check Your Drinking (CYD)|"Internet based program of lower intensity as compared to the Alcohol Help Centre. It was designed to assesses drinking patterns, increase self-awareness of individual triggers, and set and achieve goals regarding abstinence."
16236193|NCT01114919|Behavioral|Alcohol Help Centre (AHC)|"Internet based program of higher intensity as compared to the Check Your Drinking intervention. It was designed to assesses drinking patterns, increase self-awareness of individual triggers, and set and achieve goals regarding abstinence."
16236194|NCT01114893|Drug|Travoprost 0.004%|1 drop in each eye once daily for five days, and 1 drop vehicle in each eye 7 times daily for 5 days
16236195|NCT01114893|Drug|Travoprost Vehicle|1 drop in each eye 8 times daily for 5 days
16236196|NCT01114893|Drug|Travoprost (Groups A, B and C)|1 drop in each eye 8 times daily for 5 days
16236197|NCT01114880|Biological|adalimumab|Prefilled syringe, 40 mg/0.8 mL administered subcutaneously every other week
16236198|NCT01114880|Other|placebo|Prefilled syringe, matching placebo administered subcutaneously every other week
16236199|NCT01114854|Drug|Topiramate IR|
16236200|NCT01114854|Drug|Topiramate ER|
16236201|NCT01114841|Drug|Tazarotene Foam|"Patches containing Tazarotene Foam 0.1% will be applied to randomized sites on the subject's back and will be assessed 3 times per week for 3 weeks. Patches will be removed and evaluated every 48 to 72 hours.
~There will be a 10-14 day rest period followed by a single 48-hour patch application (challenge).
~These patches will then be evaluated at 24, 48, and 72 hours.
~There may be a second rest period and a second 48-hour patch application and evaluation, if required."
16236202|NCT01114841|Drug|Vehicle Foam|"Patches containing Vehicle Foam will be applied to randomized sites on the subject's back and will be assessed 3 times per week for 3 weeks. Patches will be removed and evaluated every 48 to 72 hours.
~There will be a 10-14 day rest period followed by a single 48-hour patch application (challenge).
~These patches will then be evaluated at 24, 48, and 72 hours.
~There may be a second rest period and a second 48-hour patch application and evaluation, if required."
16236203|NCT01114828|Drug|OPC-41061|Once-daily oral administration of OPC-41061 at 3.75 mg after breakfast for 7 days
16236204|NCT01114828|Drug|OPC-41061|Once-daily oral administration of OPC-41061 at 7.5 mg after breakfast for 7 days
16236205|NCT01114802|Behavioral|Project Onward website + social network|The website will include 8 weeks of Internet-based cognitive behavioral therapy combined with discussion and support from a group of up to 8 other cancer survivors.
16236206|NCT01114802|Behavioral|Project Onward website|Access to an interactive website that provides 8 weeks of Internet-based cognitive behavioral therapy.
16236207|NCT01114789|Other|Proteolysis|protocol designed to examine the effect of obesity on muscle proteolysis in hemodialysis and control
16236208|NCT01114750|Drug|Insulin in dextran matrix capsule (and placebo)|Single dose capsule (and placebo)
16236209|NCT01114737|Drug|Sapropterin dihydrochloride|A dose of 20 mg/kg/day will be administered. Route of administration is oral (intact).
16236210|NCT01114737|Drug|Placebo|Placebo (tablet without active ingredient) is dosed once/day for the first 13 weeks of the study.
16236383|NCT01113372|Drug|Clopidogrel|Clopidogrel 75mg daily.
16236214|NCT01114698|Drug|JNJ26489112|JNJ26489112 500 mg/day orally administered once daily as 2 capsules for the first 3 weeks, then dose may be increased to 1000 mg/day by week 4.
16236215|NCT01114685|Dietary Supplement|AlgaeCal-1|Daily consumption of 7 capsules containing bone health ingredients
16236216|NCT01114685|Dietary Supplement|AlgaeCal-2|Taking 7 capsules a day for six months
16236217|NCT01114672|Drug|50,000 Units Ergocalciferol|50,000 Units oral ergocalciferol to be given once weekly
16236218|NCT01114672|Drug|Placebo|oral placebo once weekly
16236219|NCT01114646|Device|Cemented Hip Hemiarthroplasty|The cemented femoral prosthesis is a VerSys LD/Fx, Zimmer, Warsaw, IN.
16236220|NCT01114646|Device|VerSys Beaded FullCoat, Zimmer|The press-fit component is a VerSys Beaded FullCoat, Zimmer, Warsaw, IN,
16236221|NCT01114620|Biological|Arepanrix™|Intramuscular administration, one dose
16236222|NCT01114607|Drug|GSK1605786 ChemoCentryx: formulation A|ChemoCentryx formulation A will be an opaque Swedish orange body, blue coloured capsule with size zero, administered 30 minutes after standard breakfast.
16236223|NCT01114607|Drug|GSK1605786 GSK: formulation B|GSK1605786 formulation B will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
16236224|NCT01114607|Drug|GSK1605786 GSK direct-fill: formulation C|GSK1605786 formulation C will be an opaque Swedish orange body capsule with size 1, administered 30 minutes after standard breakfast.
16236225|NCT01114607|Drug|GSK1605786 GSK modified-process: formulation D|GSK1605786 formulation D will be an opaque Swedish orange body capsule with size 0, administered 30 minutes after standard breakfast.
16236226|NCT01114607|Drug|GSK1605786 GSK tablet: formulation E|GSK1605786 formulation D will be a pink coloured film coated tablet, administered 30 minutes after standard breakfast.
16236227|NCT01114581|Drug|Mucinex|Mucinex 1200mg (Guaifenesin) given as 2,600mg tablets, one time on day 1 of the study
16236228|NCT01114581|Drug|Placebo|Placebo given as 2 tablets
16236229|NCT01114568|Drug|Ertugliflozin 10 mg tablet|A single dose of 10 mg ertugliflozin administered as 2x5 mg material sparing formulation tablets.
16236230|NCT01114568|Drug|Ertugliflozin OC Fast|Formulation B) Ertugliflozin 10 mg OC Fast
16236231|NCT01114568|Drug|Ertugliflozin OC Slow|Formulation C) Ertugliflozin 10 mg OC Slow
16236232|NCT01114555|Drug|Bevacizumab, Irinotecan and Temozolomide|Patients will initially receive bevacizumab IV at 15mg/kg/dose (this is defined as Day 1 Three days later (starting day 4), they will receive concurrently, IV irinotecan at 50mg/m2/day x 5 days plus PO temozolomide 150mg/m2/day x 5 days. A second dose of bevacizumab will be administered 14 days after the first one(day 15). The treatment schedule may require minor adjustment as clinically indicated (e.g., due to PDH closure for holidays).
16236233|NCT01114542|Drug|insulin degludec|Subjects were randomised to one of three possible dose levels (low, middle or high) and to one of two treatment sequences. A treatment sequence consisted of 2 periods of each 13 days. One dose once daily. The trial products were administered subcutaneously (under the skin)
16236234|NCT01114542|Drug|insulin glargine|Subjects were randomised to one of three possible dose levels (low, middle or high) and to one of two treatment sequences. A treatment sequence consisted of 2 periods of each 13 days. One dose once daily. The trial products were administered subcutaneously (under the skin)
16236235|NCT01114529|Drug|Everolimus|Early CNI to everolimus conversion
16236236|NCT01114529|Drug|Prograf or Neoral|Active CNI-based control (Prograf or Neoral)
16236237|NCT01114516|Drug|Indomethacin and antibiotics (cefazolin or clindamycin)|q8hr dosing of po indomethacin 50mg X 24 hrs and q8 hr 1 g IV cefazolin or 600 mg IV clindamycin
16236238|NCT01114503|Drug|Otelixizumab - low dose|8 day dose rising intravenous infusions of a low dose of otelixizumab
16236239|NCT01114503|Drug|Otelixizumab - medium low dose|8 day dose rising intravenous infusions of a medium low dose of otelixizumab
16236240|NCT01114503|Drug|Otelixizumab - medium high dose|8 day dose rising intravenous infusions of a medium high dose of otelixizumab
16236241|NCT01114503|Drug|Otelixizumab - high dose|8 day dose rising intravenous infusions of a high dose of otelixizumab
16236242|NCT01114503|Drug|Otelixizumab|8 day dose rising intravenous infusions of otelixizumab administered at a dose decided upon results from Part A.
16236243|NCT01114503|Drug|Methylprednisolone|Weekly intravenous infusions of methylprednisolone administered as 500 mg per week for 6 weeks and then 250 mg per week for 6 weeks
16236244|NCT01114490|Drug|anacetrapib|single dose administration of anacetrapib (MK0859) 100 mg oral tablet
16236245|NCT01114451|Procedure|Removal of surgical skin staples|Skin staples will be removed using standard technique with subsequent placement of steri-trips
16236246|NCT01114438|Device|EndoBarrier Gastrointestinal Liner|EndoBarrier Gastrointestinal Liner is intended to remain in vitro for 12 months.
16236247|NCT01114425|Drug|raltegravir (Isentress)|raltegravir (Isentress) 400 mg bid
16236248|NCT01114425|Drug|Truvada®|
16236249|NCT01114399|Dietary Supplement|Diet and Vascular Health|One group will consume 400g of standard broccoli each week for 12weeks; the second group will consume 400g of the high glucosinolate broccoli each week for 12weeks while the third group will consume 400g of peas each week for 12weeks. The broccoli and the peas will be consumed on top of the volunteer's standard diet.
16236250|NCT01114399|Dietary Supplement|Diet and Vascular Health|One group will consume 400g of standard broccoli each week for 12weeks; the second group will consume 400g of the high glucosinolate broccoli each week for 12weeks while the third group will consume 400g of peas each week for 12weeks. The broccoli and the peas will be consumed on top of the volunteer's standard diet.
16236251|NCT01114399|Dietary Supplement|Diet and Vascular Health Study|One group will consume 400g of standard broccoli each week for 12weeks; the second group will consume 400g of the high glucosinolate broccoli each week for 12weeks while the third group will consume 400g of peas each week for 12weeks. The broccoli and the peas will be consumed on top of the volunteer's standard diet.
16236252|NCT01114386|Procedure|Lung function testing, echocardiography, blood sampling|"All patients will undergo to:
~physical examination
~6' Minute Walk test
~pulmonary function testing (spirometry + volumes and reversibility testing)
~carbon monoxide diffusing capacity (DLCO) with single-breathe technique
~ECG
~echocardiography"
16236253|NCT01114373|Drug|Melatonin|Melatonin (N-acetyl-5-methoxytryptamine) is an indoleamine compound. Subjects will receive 24mg of time release melatonin pills (3 x 8mg) to be taken orally at night for 4 weeks.
16236254|NCT01114373|Drug|Placebo|Subjects will receive placebo pills (3 pills) to be taken orally once per night for 4 weeks.
16236255|NCT01114360|Drug|Melatonin|Melatonin (N-acetyl-5-methoxytryptamine) is an indoleamine compound. Subjects will receive 8 mg time-release melatonin pills, orally, once per night for 4 weeks.
16236256|NCT01114360|Drug|Placebo|Subjects received placebo pills (3 pills of 8 mg each) to be taken orally once per night for 4 weeks.
16236257|NCT01114347|Dietary Supplement|cranberry type A pro anthocyandines|One gel capsule containing cranberry PAC (36 mg of type A pro anthocyandines: Urell, Pharmatoka) per day starting at the day of the pelvic surgery (j0) until day 10 postop (j10). The gel capsule in taken orally in the morning with a large glass of water
16236258|NCT01114347|Dietary Supplement|Placebo|One placebo gel capsule per day starting on the day of the pelvic surgery (j0) until the 10th day post-op (j10). The gel capsule is taken orally in the morning with a large glass of water. The placebo contains lactose and is conditioned in a manner to be identical in caliber and color with the experimental treatment gel capsules.
16236259|NCT01114334|Behavioral|Guideline-Based Medical Management|We used the Colorado Clinical Guidelines Collaborative treatment guideline for Major Depression. It recommends treatment options e.g. specialty mental health counseling, antidepressant treatment, physical activity, depending upon presenting symptoms severity and other factors. The assessor notifies the clinician at the baseline visit about the patient's PHQ-9 depressive symptom severity score.
16236260|NCT01114334|Behavioral|Motivational Interviewing for Depression|Intervention providers receive training to utilize Motivational Interviewing to frame discussions around depression, and to improve treatment uptake and treatment adherence for depression. Primary care providers are encouraged to apply MI to a broad conceptualization of 'treatment' including specialty mental health referral, antidepressant treatment, physical activity, and to targeting contributing factors e.g. loss of job or physical health problems.
16236261|NCT01114321|Behavioral|Protein and calorie controlled diet|Protein and calorie controlled diet Self-hypnotic relaxation
16236262|NCT01114308|Drug|Probuphine (buprenorphine implant)|Implantable formulation of buprenorphine made of buprenorphine HCl/ethylene vinyl acetate, considered a drug.
16236263|NCT01114308|Drug|placebo implant|Implant contains ethylene vinyl acetate
16236264|NCT01114308|Drug|Buprenorphine|sublingual buprenorphine/naloxone tablets
16236265|NCT01114295|Device|Capsule Endoscopy|Prior to the test, patients will be on a clear liquid diet for 24 hours and will have undergone an overnight fast. If a clear liquid diet is not possible, some patients may undergo a bowel preparation the day before the procedure. On the morning of the test, patients will swallow a video capsule with water. Clear liquids will be permitted after 2 hours, and a light meal permitted 4 hours after swallowing the capsule, if appropriate. No medications will be allowed 2 hours before the procedure and drugs that can delay gastric emptying will be avoided until the study is complete. At 8 hours after ingestion, the sensor array and recorder/battery belt pack will be disconnected and the data will be downloaded onto a computer equipped with software for image viewing. Images are sent through 8 skin electrodes to the recorder, stored and viewed on a RAPID workstation. At the end of the recording, the video is transferred to a computer for analysis.
16236266|NCT01114295|Radiation|CT Enterography|CT enterography at the Brigham and Women's hospital is performed by using intravenous iodinated contrast material (Ultravist 300) and a neutral oral-enteric contrast material containing methylcellulose (Volumen). During scanning, 150 mL of nonionic intravenous contrast medium will be administered at a rate of 3mL/sec and the imaging conducted 40 and 70 seconds after the administration of the intravenous contrast medium. All imaging will be performed on a Dual-Energy multi-detector row CT scanner, Somatom Definition (Siemens Healthcare, Forcheim, Germany). Two independent X-ray tube/detector system will be used for image acquisition. One tube operates at 140 kV and the other at 80 kV . Slice collimation will be 0.6 mm and images reconstructed at 3 mm thickness with 3 mm reconstruction intervals. Coronal and sagittal images will be reconstructed at 3 mm thickness with 3 mm increments. Images will be reviewed by a radiologist experienced in the interpretation of CT enterography.
16236267|NCT01114282|Drug|velcade|
16236268|NCT01114282|Drug|Pralatrexate|
16236269|NCT01114256|Procedure|FNA Biopsy|
16236270|NCT01114243|Device|Ultrasound imaging|
16236271|NCT01114230|Drug|AGS-16M8F|IV
16236272|NCT01114217|Drug|Ferumoxytol|IV Ferumoxytol
16236273|NCT01114204|Drug|Ferumoxytol|IV Ferumoxytol
16236274|NCT01114204|Drug|Iron Sucrose|IV Iron Sucrose
16236275|NCT01114191|Drug|ABT-869|2.5mg [5 mg days 1, 8 and 12. 17.5 mg on days 13 and after]
16236276|NCT01114191|Drug|ketoconazole|400 mg days 6-11
16236277|NCT01114178|Other|questionnaire|self completed questionnaire supervised by a technician
16236278|NCT01114165|Other|Detection of microbial DNA in blood by SeptiFast Test|The SeptiFast Test is a multiplex polymerase chain reaction (PCR) test that can detect nucleic acids from the most common pathogens (approximately 90%) responsible for hospital-associated bacteremia and takes approx. 6 hours to perform
16236279|NCT01114165|Other|Pathogen detection by blood culture|Blood culture is a conventional microbiological method of pathogen detection. Results from blood cultures are usually not available until 24 to 72 hours after sampling
16236280|NCT01114152|Drug|AZD9742|IV Formulation
16236281|NCT01114152|Drug|Placebo|IV Formulation
16236282|NCT01114139|Drug|Ferumoxytol|IV Ferumoxytol
16236283|NCT01114139|Other|Placebo|IV Placebo
16236284|NCT01114126|Drug|Neu-P11|comparison of different dosages of drug
16236285|NCT01114126|Drug|Neu-P11 placebo|comparison of different dosages
16236286|NCT01114113|Drug|pancelipase/placebo|"ZenPep 20000 units of lipase will be provided for the participant to take with a trigger meal or an identical placebo. This will only be given to those participants willing to consume 2 more identical trigger meals and will not be given for the initial baseline non-trigger and baseline trigger meal. In both of these arms, patients will also be swallowing the SmartPill Capsule."
16236287|NCT01114113|Device|SmartPill capsule|Measurement of a baseline, non-trigger meal intestinal transit by using the SmartPill capsule.
16236288|NCT01114113|Device|SmartPill capsule|"Measurement of intestinal transit of a trigger meal baseline by using the SmartPill capsule"
16236289|NCT01114113|Device|SmartPill capsule|SmartPill capsule
16236290|NCT01114100|Drug|sertraline|starting dose 25 mg for 1 week, the increasing to 50 mg, after each visit evaluation whether dosage has to be increased to maximally 150 mg
16236291|NCT01114100|Drug|placebo|patients received 1 pill, according to their complaints the number of pills was increased to maximally 3
16236292|NCT01114087|Drug|Imatinib treatment|Imatinib is a tyrosin-kinase inhibitor
16236293|NCT01114061|Device|Insupatch|Applying heat to the infusion site using the insupatch device
16236294|NCT01114048|Drug|Thalidomide, cyclophosphamide, dexamethasone, bortezomib|"Induction therapy with CTD regimen for 4 cycles Thalidomide 50-100 mg P.O. HS D 1~28 Cyclophosphamide 150 mg/m² P.O. D 1~4 Dexamethasone 20 mg/ m² IV or P.O. D 1~4, 15-18 Repeated every 28 days
~Intensification with Vel-CD regimen for 4 cycles (patients who fail to achieve more than PR after 2 cycles of CTD) Velcade 1.3 mg/m2 IV D1, 4, 8, 11 Cyclophosphamide 150 mg/m² P.O. D 1~4 Dexamethasone 20 mg/ m² IV or P.O. D1, 4, 8, 11 Repeated every 21 days
~Bactrim prophylaxis during dexamethasone administration Acyclovir prophylaxis during velcade administration Aspirin medication during thalidomide administration"
16236295|NCT01114035|Genetic|blood samples and skin biopsies|to detect mutations
16236296|NCT01114035|Genetic|Skin biopsies|to detect mutations
16236297|NCT01114022|Device|Experimental 1|oeso pharyngeal device
16236298|NCT01114022|Device|Experimental|oeso pharyngeal device
16236299|NCT01114022|Device|experimental 3|oeso pharyngeal device
16236300|NCT01114022|Device|Active comparator|oeso pharyngeal device
16236301|NCT01114009|Procedure|Lung recruitment maneuver|Lung recruitment maneuver conducted with a PEEP 35 cmH2O and peak inspiration pressure up to 50 cmH2O maintain 2 mins, then find the closing pressure (if possible), after that, PEEP is set higher 2 cmH2O above closing pressure
16236302|NCT01114009|Procedure|Lung protective strategy group|Lung protective strategy group received Lung protective strategy without recruitment maneuver
16236303|NCT01113996|Behavioral|Protein supplementation and strength training|Protein supplementation and strength training
16236304|NCT01113996|Dietary Supplement|Protein supplementation|Protein supplementation
16236305|NCT01113983|Device|Transcatheter aortic valve implantation|Transcatheter aortic valve implantation via transapical and transfemoral approach
16236306|NCT01113970|Drug|Indibulin|Indibulin given orally once a day for 5 days followed by a 9 day rest
16236307|NCT01113957|Drug|ABT-888|Arm-A subjects will be given ABT-888 on Days 1 -7 every 28 days orally
16236308|NCT01113957|Drug|pegylated liposomal doxorubicin|Arm B subjects randomized to pegylated liposomal doxorubicin on Day 1, every 28 days intravenously.
16236309|NCT01113957|Drug|temozolomide|Arm A subjects will be given temozolomide on days 1-5 every 28 days orally with ABT-888
16236310|NCT01113944|Behavioral|Program 1|
16236311|NCT01113944|Behavioral|Program 2|
16236312|NCT01113931|Drug|Doxycyline Hyclate tablet|200 mg tablet, once daily for 7 days
16236313|NCT01113931|Drug|Vibramycin (doxycyline hyclate) capsule|100 mg capsule, twice daily for 7 days, over-encapsulated
16236314|NCT01113892|Device|vascular grafts|All devices will be used to treat patients with peripheral arterial occlusive disease
16236315|NCT01113879|Behavioral|Aerobic exercise|An aerobic exercise intervention will target cardiorespiratory fitness by progressing from 50-70% of the participants' maximum heart rate.
16236316|NCT01113879|Behavioral|Stretching|Stretching will occur for 50 minutes a day, three days/week for 12 weeks.
16236317|NCT01113840|Behavioral|Exercise|Exercise classes three times per week in a controlled, supervised environment.
16236318|NCT01113840|Behavioral|Control|Control group continues daily life as prior to randomization.
16236319|NCT01113827|Dietary Supplement|Olive Extract|Capsule form ingested 1x/day for 6 weeks
16236320|NCT01113827|Dietary Supplement|Placebo|Placebo
16236321|NCT01113814|Device|FibroScan|
16236322|NCT01113814|Device|Acoustic Radiation Force Impulse (ARFI)- Imaging|
16236323|NCT01113801|Drug|LY2382770|Subcutaneous injection given monthly for 12 months
16236324|NCT01113801|Drug|Placebo|Subcutaneous injection given monthly for 12 months
16236325|NCT01113788|Device|tricuspid isthmus imaging with Cartosound|tricuspid isthmus imaging with Cartosound
16236326|NCT01113762|Device|articular surface replacement ASR, DePuy|posterolateral incision
16236327|NCT01113762|Device|ReCap/Magnum modular head, Biomet|posterolateral incision
16236328|NCT01113762|Device|Bimetric stem, mallory/head cup, 28 mm ceramic head, Biomet|posterolateral incision
16236329|NCT01113762|Device|28 mm CrCo head, Trilogy CH cup, VerSys Fiber stem,Zimmer)|posterolateral incision
16236330|NCT01113749|Other|Feeding Options in Dementia Decision Aid|Structured decision aid on feeding options in dementia care with prompting to share information in discussion with primary treating health care provider.
16236331|NCT01113736|Biological|AlloMEM™|To investigate whether the use of HPM in a temporary loop ileostomy is beneficial to patients.
16236332|NCT01113723|Device|Fiberoptic bronchoscope|Fiberoptic bronchoscope device
16236333|NCT01113723|Device|CMAC|CMAC Device
16236334|NCT01113710|Drug|Neupro®|Neupro® is the exposure/intervention of interest in this non-interventional study.
16236335|NCT01113684|Device|Implantable pulse generator (deep brain stimulator)|This study evaluates the effects of subthalamic deep brain stimulation on central and peripheral nervous system activity in patients who have already had brain stimulators placed as a matter of routine clinical care.
16236336|NCT01113671|Drug|Vitamin E (d-alpha-tocopheryl acetate)|100% natural source d-alpha-tocopheryl acetate in a soft gel cap
16236337|NCT01113671|Drug|Placebo|includes inactive Ingredients
16236338|NCT01113658|Device|SNaP Wound Care System|"The intervention is negative pressure wound therapy (NPWT) with the Spiracur SNaP Wound Care system for the treatment of a variety of acute and chronic wounds including pressure ulcers, trauma wounds, diabetic foot ulcers, venous stasis ulcers, and skin grafts.
~The Spiracur SNaP Wound Care system weighs less than 4 ounces, does not utilize an electric pump (device has no electrically powered parts), is fully disposable after use, and is designed for particularly small chronic wounds that require advanced wound care management. It delivers NPWT at a constant pressure level over several days without any required adjustments by the patient or clinician."
16236384|NCT01113346|Drug|Filtrum-STI (lignin hydrolytic)|"For children aged less than 1 y.o.: Filtrum-STI, 400mg per day (1/2 tablet 2 times a day) for 7 days.
~For children aged 1-4 y.o.: Filtrum-STI, 800mg per day (1 tablet 2 times a day) for 7 days."
16236543|NCT01111968|Biological|pandmeic vaccine 12|3,75µg of A/H1N1 with Al(OH)3
16236339|NCT01113645|Procedure|Cerebral perfusion evaluation|The patient who received a craniectomy is included in the study and an information notice given to him. All patients are evaluated by GOS (Glasgow Outcome Score) and neurocognitive tests by FAB (frontal assessment battery) and MMSE (mini mental state examination) scores 1 week prior and 6 and 24 weeks post cranioplasty. Furthermore, hemodynamic monitoring is performed by CT perfusion scan (with quantitative assessment of global and local cerebral flow) 1 week prior and 6 weeks post cranioplasty, as well as by trans-cranial Doppler 1 week prior and 6 and 24 weeks post cranioplasty.
16236340|NCT01113632|Drug|Ofatumumab|IV infusion once weekly for a total of 8 weeks. Patients will visit the study center once weekly to receive their IV infusion of ofatumumab. To reduce the possibility of infusion reactions, the first dose of ofatumumab will be administered at a dose of 300 mg. If the initial 300 mg dose of ofatumumab is well tolerated, without occurrence of any infusion-associated AEs of ≥ grade 3, subsequent doses of ofatumumab (i.e., Week 2 through Week 8) will be at a dose of 2000 mg.
16236341|NCT01113619|Drug|RP-G28 or placebo|Qualified subjects randomized to daily dosing with RP-G28 or placebo
16236342|NCT01113619|Drug|RP-G28 or placebo|Daily dosing
16236343|NCT01113606|Other|Obagi New-Derm System|
16236344|NCT01113606|Other|Standard of Care|
16236345|NCT01113593|Drug|Formoterol Fumarate|Inhalation solution
16236346|NCT01113593|Drug|Formoterol Fumarate|Inhalation solution
16236347|NCT01113593|Drug|Formoterol Fumarate|Inhalation solution
16236348|NCT01113593|Drug|Foradil Aerolizer|Dry powder inhaler
16236349|NCT01113593|Drug|Foradil Aerolizer|Dry powder inhaler
16236350|NCT01113580|Biological|CSL's 2010/2011 Formulation of Enzira® Vaccine|45 mcg of HA antigen in 0.5 mL administered by intramuscular injection into the deltoid region of the arm on Day 0
16236351|NCT01113567|Dietary Supplement|Lactose-free milk|3.5 g of lactose
16236352|NCT01113567|Dietary Supplement|Whole milk|Whole milk with 24 g lactose
16236353|NCT01113554|Other|questionnaire administration|
16236354|NCT01113554|Behavioral|exercise intervention|
16236355|NCT01113554|Procedure|quality-of-life assessment|
16236356|NCT01113554|Other|survey administration|
16236357|NCT01113554|Procedure|management of therapy complications|
16236358|NCT01113554|Procedure|psychosocial assessment and care|
16236359|NCT01113541|Drug|Ziprasidone HCL (oral)|Ziprasidone Hydrochloride 20 to 80 mg administered orally twice a day (40-160 mg total daily dose) for up to 1 year.
16236360|NCT01113528|Other|Regenerative therapy (omega 3 PUFA plus low dose aspirin)|Comparison between regenerative bone graft alone and bone graft + Omega-3 and low dose aspirin
16236361|NCT01113528|Drug|Sugar pill|3 times daily
16236362|NCT01113515|Drug|Esmolol hydrochloride|
16236363|NCT01113515|Drug|Esmolol hydrochloride|
16236364|NCT01113515|Drug|Esmolol hydrochloride|
16236365|NCT01113515|Drug|Placebo gel|
16236366|NCT01113502|Drug|Eltrombopag|Oral formulation taken daily
16236367|NCT01113489|Drug|beclomethasone dipropionate|400 mcg/1 ml b.i.d.
16236368|NCT01113489|Drug|placebo|1 ml b.i.d.
16236369|NCT01113476|Drug|Nab-paclitaxel|Starting dose of 50 mg/m^2 on Day 1, 8 + 15 every 28 days (+/- 2 days)
16236370|NCT01113476|Drug|Bevacizumab|Starting dose of 5 mg/m^2 on Day 1 + 15 every 28 days (+/- 2 days)
16236371|NCT01113476|Drug|Gemcitabine|1000 mg/kg Day 1, 8 + 15 every 28 days (+/- 2 days)
16236372|NCT01113463|Drug|TPI 287|Starting dose of 160 mg/m^2 as a 60-minute (± 10 minutes) IV infusion once every 3 weeks, (i.e., 1 cycle = 21 days).
16236373|NCT01113437|Drug|Omalizumab|"Omalizumab or placebo by subcutaneous injections, at 4 weekly or 2 weekly intervals.
~Dosage is according to manufacturer's guidance and calculated based on body weight and total serum IgE."
16236374|NCT01113437|Drug|Placebo|"Omalizumab or placebo by subcutaneous injections, at 4 weekly or 2 weekly intervals.
~Dosage is according to manufacturer's guidance and calculated based on body weight and total serum IgE."
16236375|NCT01113424|Drug|Nicotine|Single-dose of a new Nicotine Replacement Therapy (NRT) product 2 mg and 4 mg
16236376|NCT01113424|Drug|Nicorette® (Nicotine Gum)|Single-dose of marketed nicotine gum 2 mg or 4 mg
16236377|NCT01113411|Device|PHILOS™ locked plate system by Synthes Canada©|The surgery will be performed under standardized general anesthetic with a prophylactic antibiotic. The deltopectoral approach is used in all cases. The fracture will be fixed using the PHILOS locked plate system by Synthes Canada ©. Some additional osteosutures may be used. The wound is irrigated and then closed in two layers at the end of intervention. A splint thoracic brace will be installed in all patients before the end of anesthesia.
16236378|NCT01113411|Other|Early and intensive exercise program|"A thoraco brachial brace will be worn for 48 hours following the surgery and then removed for the remainder of treatment. Patients will then start the intensive rehabilitation program without physical therapy. The exercise program will be provided to the patient.
~The exercises consist of active and active assisted movements of the shoulder for a period of six weeks, limiting external rotation to 0 °. Patients are encouraged to use their affected limb for daily activities. Strengthening exercises are started the 6th week following surgery and the full program will be completed three months after surgery. Patients who wish can then continue their rehabilitation with a physiotherapist.
~The patient will complete a daily diary to validate the frequency and intensity of the exercises."
16236379|NCT01113411|Other|Standard rehabilitation program|The patient will wear the thoraco brachial brace for a period of four weeks following the surgery. It may be taken off for hygiene purposes and dressing up. After the four weeks, the patient will take the brace off permanently and begins an exercise program, writing down the frequency and intensity of the exercises. Physiotherapy is allowed for the remaining part of the three months rehabilitation program.
16236380|NCT01113398|Drug|AMG 102|AMG 102 will be administered as a continuous intravenous infusion by an infusion pump at 20 mg/kg every 2 weeks over 60 or 30 minutes.
16236381|NCT01113398|Drug|Avastin|Avastin will be administered as a continuous intravenous infusion at 10 mg/kg every 2 weeks (6-week study cycle) over 60 or 30 minutes. Avastin will be given prior to AMG 102.
16236382|NCT01113385|Drug|D-Galactose|Oral galactose will be initiated at a dose of 0.2gm/kg/dose twice daily to a maximum of 15 gm BID for a period of 4 months. The prescribed dose of D-galactose powder will be dispensed to subjects in packets, mixed with 4 ounces of water, and consumed orally.
16236385|NCT01113346|Drug|Placebo|"For children aged less than 1 y.o.: Placebo, 1/2 tablet 2 times a day for 7 days.
~For children aged 1-4 y.o.: Placebo, 1 tablet 2 times a day for 7 days."
16236386|NCT01113333|Drug|placebo|"Pharmaceutical form:injection
~Route of administration: intra-articular"
16236387|NCT01113333|Drug|SAR113945|"Pharmaceutical form:injection
~Route of administration: intra-articular"
16236388|NCT01113320|Drug|Placebo|Evaluable dose levels are 100 mg (8 days), 200 mg (10 days), and 300 mg (42 days). Intermediate dose levels are 150 mg (Study days 9-11) and 250 mg (Study days 23-25) and have a duration of three days. Safinamide and identical Placebo will be provided in tablets equivalent of 50 mg in blisters. Dosing will be achieved using appropriate multiples of these tablet strengths
16236389|NCT01113320|Drug|Safinamide|Evaluable dose levels are 100 mg (8 days), 200 mg (10 days), and 300 mg (42 days). Intermediate dose levels are 150 mg (Study days 9-11) and 250 mg (Study days 23-25) and have a duration of three days. Safinamide will be provided in tablets of 50 mg in blisters. Dosing will be achieved using appropriate multiples of these tablet strengths
16236390|NCT01113307|Biological|Activated allogeneic white blood cells|The CUREXCELL™ dosage form consists of an activated cell suspension that has been isolated, activated and purified from the peripheral blood of healthy allogeneic donors, by hypo-osmotic shock, using the MacroCure custom closed bag system.The cell suspension is superficially injected throughout the wound bed ( 0.1ml per 1 cm2 of wound bed).
16236391|NCT01113294|Procedure|catheter ablation|circumferential pulmonary vein isolation complex fractionated atrial electrograms ablation circumferential pulmonary vein isolation combined left atrial roof ablation circumferential pulmonary vein isolation combined left atrial isthmus ablation circumferential pulmonary vein isolation combined left atrial roof and isthmus ablation circumferential pulmonary vein isolation combined complex fractionated atrial electrograms ablation
16236392|NCT01113281|Biological|VPM1002 live vaccine|
16236393|NCT01113281|Biological|commercially available live vaccine BCG|
16236394|NCT01113268|Other|Cohort|Our main goal is to create a prospective cohort of 1500 patients with a first large myocardial infarction allowing us, in a second step, to identify susceptibility genes for the progression of patients towards chronic heart failure using a candidate gene/candidate pathway approach.
16236395|NCT01113255|Procedure|bench-evaluation, of three ventilators|to select in-VITRO the most appropriate ventilator for a given pathology.
16236396|NCT01113242|Other|Neuropsychological Assessment|Included patients had clinically idiopathic PD, were over 65 years old and presented with a cognitive complain. A detailed registration of clinical history (including review of motor, cognitive, and neuropsychiatric symptoms, comorbid medical conditions, and medications) and neurologic examination was performed. Exclusion criteria included other conditions than PD that could contribute substantially to the subject's motor and/or cognitive impairment, including neurologic and major psychiatric disorders ( delirium,…) affecting the cognitive functions. Patients with major cognitive impairment (i.e. Mental State Examination (MMSE) <16/30) were also excluded.). Neuropsychological assessment explores working memory, episodic memory ,verbal fluency, executive functions and visuo constructive functions.
16236397|NCT01113229|Drug|Misoprostol|two misoprostol tablets taken orally (400µg)
16236398|NCT01113203|Behavioral|Resistance training|Progressive high intensity resistance training performed twice a week for 16 weeks, and achieving in 7 exercises for the main muscles, the protocol of 4 sets of 6RM and 2 of 4RM.
16236399|NCT01113190|Behavioral|Computer-delivered Brief Intervention (CBI)|"The multimedia, interactive Computer BI (CBI) condition will be delivered using tablet computers. The content and format will be easily negotiated by participants. The proposed CBI condition will use actors with 'green screen' to deliver scripted therapist content that will be highly tailored to individual responses. 'Green screens' are standard recording formats that allow for inserting engaging background and other overlays onto recorded material. This program will be viewed on a touch screen tablet computer with audio delivered via headphones. The CBI will be designed in a therapist video-delivered interactive style, that provides tailoring options for reviewing patient goals, providing feedback regarding substance use patterns and consequences, completing a decisional balance exercise, and formulating a change plan. It requires active participation and is not a passive video that is merely viewed."
16236400|NCT01113190|Behavioral|Intervener-delivered Brief Intervention (IBI)|"IBI is a 30-minute intervention session with a master's-level clinician. The interventions will include FRAMES (Miller & Rollnick, 2002): personalized Feedback (regarding substance use, risk factors), emphasis on Responsibility for change, Advice, Menu of options, Empathic clinical behaviors, and support of Self-Efficacy regarding making changes. The interventions are designed to address the primary target behavior of drug use, and will include a tailored review of participants' goals/values, feedback regarding their present substance use patterns and consequences, developing a discrepancy between their substance use and ability to meet goals and values through a decisional balance exercise, and formulation of a change plan tailored for each participant. IBI will be highly individualized to participants' goals, values and substance use, and will will follow similar session outlines and length of delivery as the CBI sessions."
16236401|NCT01113190|Behavioral|Adapted Motivational Enhancement Therapy (AMET)|This session will have a similar general outline to the sessions conducted in the ED, including a review of participants' goals and values, and a review of their substance use and consequences, use of decisional balance exercises as indicated, and review and modification of their change plan. For the AMET intervention, the intervener (at least master's level) will conduct a single session (~30-45 minutes) in the community (HMC ED or our community research office). The therapist will be able to tailor their approach to each individual's needs and motivational state.
16236402|NCT01113190|Behavioral|Enhanced Usual Care (EUC)|The EUC group will receive brief advice to change their drug use, as well as a booklet including information on community support groups, location of substance use treatment centers, mental health services, suicide prevention hotlines, risk of injecting drugs including HIV and hepatitis and HIV prevention and testing information.
16236403|NCT01113177|Device|Distraction splint therapy|After the diagnosis of unilateral TMJ arthritis with clinical asymmetric mandibular growth deviations the JIA patients are offered treatment with a distraction splint. The appliance consists of an acrylic splint (distraction splint) covering the occlusal surfaces of the teeth in the upper or lower dental arch. The height of the splint is thereafter gradually increased every 6th to 10th weeks in order to optimize the mandible growth in the affected side and thereby reduce the overall asymmetric mandibular growth pattern(non-surgical distraction of the TMJ and mandibular condyle).
16236404|NCT01113164|Drug|Ondansetron and Sertraline|capsule 0.25mg twice a day for 21 days and capsule 100mg twice a day
16236405|NCT01113151|Dietary Supplement|Mablet (Magnesium-supplement)|3 tablets daily for 12 weeks of Mablet (360 mg magnesium hydroxide/ -oxide) Produced by: Gunnar Kjems APS
16236406|NCT01113151|Other|Placebo|3 placebo tablets daily for 12 weeks
16236407|NCT01113138|Dietary Supplement|Mablet (Magnesium-supplement)|Mablet: Magnesium hydroxide/ -oxide (360 mg/tablet) 3 tablets as a single dose Produced by: Gunnar Kjems APS
16236408|NCT01113138|Drug|Magnesium Sulfate|Solution for a single bolus-infusion, containing 2 grams of magnesium sulfate.
16236409|NCT01113125|Drug|Betamethason-17-valerate and fusidic acid|0.4 cm creme is applied and covered with a plaster (treatment under occlusion). Dosage every second or third day Treatment is started one week before removal of the central venous catheter and continued for four weeks
16236410|NCT01113125|Drug|Fusidic Acid|0.4 cm creme is applied and covered with a plaster (treatment under occlusion). Dosage every second or third day Treatment is started one week before removal of the central venous catheter and continued for four weeks
16236411|NCT01113099|Other|Academic detailing|Education of physicians by pharmacists regarding indications for statins in diabetic patients
16236412|NCT01113086|Device|Transcranial direct current stimulation|Subjects will receive a total of 10 stimulation sessions on consecutive days, Monday- Friday for a total of two weeks. During each session, 2 mA of tDCS will be applied for 20 minutes over the left or right DLPFC (active or sham).
16236413|NCT01113073|Other|ventilatory protocol|Ventilatory protocol for short period with four different tidal volumes (12 min)
16236414|NCT01113073|Other|Elastic band|Placement of an elastic band around thorax to reduce thorax compliance
16236415|NCT01113073|Other|passive leg raising test|performing the passive leg raising test
16236416|NCT01113047|Drug|Aliskiren/Amlodipine and Aliskiren/Amlodipine/HCTZ|Aliskiren 300 mg / Amlodipine 10 mg/HCTZ 12.5 mg
16236417|NCT01113034|Drug|DAS181 dry powder, formulation F02|10 mg delivered dose DAS181 in clear HPMC #3 Capsules
16236418|NCT01113034|Drug|Respitose ML006 (DMV-Fonterra)|Lactose monohydrate
16236419|NCT01113021|Device|Photon stimulation by low level laser therapy|
16236420|NCT01113008|Procedure|Remote ischemic postconditioning|Patients assigned to remote ischemic postconditioning will undergo three 5-minute cycles of ischemia using a blood-pressure cuff at 200 mmHg, placed on the non-dominant arm, interrupted twice for 5 minutes with the cuff deflated
16236421|NCT01113008|Procedure|Control group|In the control group the procedure will be limited to placing a deflated blood-pressure cuff (pressure: 0 mmHg) for 25 minutes.
16236422|NCT01112995|Dietary Supplement|Lactobacillus rhamnosus|1 pill formulation to be given once a day for 4 weeks
16236423|NCT01112995|Dietary Supplement|Sugar pill (placebo)|placebo identical to the active product will be given
16236424|NCT01112982|Other|Magnetic Resonance Imaging|An Magnetic Resonance Imaging (with and without gadolinium contrast) of index joint will be performed (T1, T2, and STIR images).
16236425|NCT01112982|Drug|Febuxostat|All subjects in the sub-study will be started on febuxostat 40mg daily at baseline. If their serum urate level is > 6.0 at months 1 or 3, then the febuxostat dose will be increased to 80mg daily.
16236426|NCT01112982|Drug|Colchicine|Colchicine will be dosed at 0.6mg by mouth BID for the first three months then 0.6mg daily from months 3 to 6, and then discontinued at month 6.
16236427|NCT01112969|Behavioral|Internet-based supportive coaching OSCAR|The Internet-based supportive coaching (OSCAR) is an scientifically based multicomponent intervention
16236428|NCT01112969|Other|Waiting-list control group (TAU)|Waiting-list control group (treatment as usual, TAU, no specific intervention)
16236429|NCT01112943|Other|Acupuncture|Acupuncture on predefined points for 20min once a week over seven weeks
16236430|NCT01112943|Other|Pulmonary Rehabilitation|a seven week pulmonary rehabilitation course
16236431|NCT01112943|Other|Pulmonary Rehabilitation|Twice a week for seven weeks. Each session lasting 2 hrs (1hr exercise and 1hr education
16236432|NCT01112917|Device|VenaTech Convertible Vena Cava Filter|Prevention of Pulmonary Embolism
16236433|NCT01112917|Procedure|Vena Cava Filter Conversion|Conversion of VenaTech Convertible filter to open configuration.
16236434|NCT01112891|Drug|Vitamin D|10 ug/day Vitamin D as part of standard pre-natal vitamin supplement, taken from 18 weeks gestation to 6 months postpartum.
16236435|NCT01112891|Drug|Vitamin D3|25 ug/day Vitamin D as part of standard pre-natal vitamin supplement, taken from 18 weeks gestation to 6 months postpartum.
16236436|NCT01112891|Drug|Vitamin D|50 ug/day Vitamin D as part of standard pre-natal vitamin supplement, taken from 18 weeks gestation to 6 months postpartum.
16236437|NCT01112878|Drug|Sugar pill|"Dosage form: capsule, by mouth
~Dosage: not applicable
~Frequency and Dosage:
~once in the preoperative holding area and once before discharge from PACU
~continuation of 1 capsule twice daily with meals, 1 to 4 days after surgery."
16236438|NCT01112878|Drug|Gabapentin|"Dosage form: capsule, by mouth
~Dosage: 600 mg
~Frequency and duration:
~once in the preoperative holding area and once before discharge from PACU
~continuation of 1 capsule twice daily with meals, 1 to 4 days after surgery."
16236439|NCT01112878|Drug|Clonidine|"Dosage form: capsule, by mouth
~Dosage: 0.2 mg
~Frequency and duration:
~once in the preoperative holding area and once before discharge from PACU
~continuation of 1 capsule twice daily with meals, 1 to 4 days after surgery."
16236440|NCT01112865|Device|Genotropin Pen|Pen provided in 5, 5.3 and 12 mg doses, Dose based on body weight, subcutaneous injection daily for 2 months while in study.
16236441|NCT01112865|Device|MARK VII pen|Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.
16236442|NCT01112865|Device|Genotropin Pen|Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.
16236443|NCT01112865|Device|MARK VII pen|Pen provided in 5, 5.3 and 12mg doses, dose based on body weight, subcutaneous injection daily for 2 months while in study.
16236444|NCT01112852|Drug|pantoloc 40 mg|pantoloc iv. infusion per day
16236445|NCT01112852|Drug|somatostatin or terlipressin|Somatostatin 6mg in 500 cc 5% dextrose, 250μg slow bolus IV infusion followed by 250μg per hour (6mg/ 24 hours) or Terlipressin 2mg bolus was instituted on enrollment followed by 1mg per 6 hours for 5 days. The use of either somatostatin or glypressin was at the discretion of doctors in charge.
16236685|NCT01110785|Drug|simvastatin|
16236446|NCT01112839|Behavioral|Less Intensive|Participants in this group would receive print materials on diet and exercise and two individual counseling sessions; one at the beginning of the study and another 6 months later.
16236447|NCT01112839|Behavioral|Intensive Group|Participants in this group would receive print materials on diet and exercise and attend group sessions that would meet weekly for the first 4 months, then every two weeks for the next 2 months, and then monthly for the next 6 months over the course of one year.
16236448|NCT01112826|Drug|Capecitabine|capecitabine 650 mg/m2 twice every day for 1 year.
16236449|NCT01112813|Drug|Lithium Carbonate|0.4-0.8 mmol/L for 2 months
16236450|NCT01112787|Drug|Tazarotene Foam|Tazarotene Foam
16236451|NCT01112787|Drug|Vehicle Foam|Vehicle Foam
16236452|NCT01112787|Drug|Sodium Laural Sulfate|Sodium Laural Sulfate
16236453|NCT01112787|Drug|Distilled Water|Distilled Water
16236454|NCT01112774|Device|Transcranial direct current stimulation|Stimulation will be applied at 2 mA for a total of 20 minutes.
16236455|NCT01112761|Device|Transcranial direct current stimulation|Each type of stimulation will be administered with a time interval of a week in between to prevent any carryover affects.
16236456|NCT01112748|Drug|Topical lidocaine patch|Topical lidocaine patch 5%; up to 3 patches to cover the area of maximum pain for 12 h a day.
16236457|NCT01112735|Biological|FS VH S/D 4 s-apr (= two-component fibrin sealant, double virus inactivated, made from pooled human plasma)|Dosage form: spray (aerosolized sealant), Dosage frequency: once (1 layer). ARTISS will be applied onto the fascia or the wound bed.
16236458|NCT01112735|Procedure|Standard of care|Standard of care
16236459|NCT01112722|Biological|Apitox, purified honeybee toxin, lyophilized in saline|intradermal injections of 0.1mg apitox in 0.1ml WFI over 12 weeks treatment period, injections twice weekly range from 1 to 20 injections
16236460|NCT01112722|Biological|histamine|imitates pain and erythema of honeybee venom
16236461|NCT01112709|Behavioral|SCT-based Resistance Training exercise program|Two supervised RT sessions per week for the first 3 months, then a self-monitored RT phase for the remainder of the study, with primarily Internet-based contact.
16236462|NCT01112709|Other|Standard Intervention with minimal contact|This is the control condition for comparison; the approach will be identical to the experimental condition, but without the theoretical components (skills to increase self efficacy for RT, self regulation for RT). Contact with the study staff will be reduced from that received by the experimental group.
16236463|NCT01112696|Device|Sensor wear|All subjects to wear sensors
16236464|NCT01112683|Drug|Memantine|The drug dosage will follow memantine's standard titration schedule (i.e., 5 mg/d week one, 5 mg/BID week two, 5 & 10 mg/d divided dose week three, 10mg/BID week four).
16236465|NCT01112683|Drug|Placebo|These are identically-looking pills to those in the Memantine Arm.
16236466|NCT01112670|Drug|Sitagliptin|sitagliptin 100 mg x 1 dose
16236467|NCT01112670|Drug|atorvastatin|atorvastatin 40 mg x 5 doses
16236468|NCT01112644|Drug|Oxycodone naloxone prolonged release tablets (OXN PR)|Different daily doses; intake every 12 hours
16236469|NCT01112644|Other|Placebo (PLA)|Different daily doses; intake every 12 hours
16236470|NCT01112579|Device|Medtronic PrimeADVANCED Neurostimulator|Heart failure therapy
16236471|NCT01112579|Device|Medtronic PrimeADVANCED Neurostimulator|Medical management
16236472|NCT01112540|Drug|Morphine|0.1 mg/kg Intravenous bolus
16236473|NCT01112527|Drug|PF-00299804|Taken orally once a day
16236474|NCT01112514|Drug|indocyanine green|Administered intravenously during endoscopic near-infrared (NIR) imaging
16236475|NCT01112488|Other|Patient Engagement Programme|Patient's Diary, Ad Hoc medical support and Ad Hoc Clinical admission, Early post discharge Home visit
16236476|NCT01112462|Drug|Paracetamol 500 mg/Phenylephrine 5 mg tablets|2 tablets to be administered orally with 240 ml of water with a 24 hour follow-up period
16236477|NCT01112462|Drug|Paracetamol 1000 mg/Phenylephrine 10 mg sachet|1 sachet dissolved in 240 ml water and administered orally with a 24 hour follow-up period
16236478|NCT01112449|Other|Placebo|no active medication
16236479|NCT01112449|Dietary Supplement|selenomethionine|200 µg/day of selenomethionine (SM)
16236480|NCT01112449|Dietary Supplement|low dose selenized-yeast|200 µg/day of SY
16236481|NCT01112449|Dietary Supplement|high dose selenized-yeast|285 µg/day of SY
16236482|NCT01112436|Drug|periarticular injection of multidrug regimen|periarticular injection of combination of ropivacaine 15 mg, epinephrine 0.3mg, cefmetazole 1000mg, ketorolac 30mg, morphine HCL 10 mg
16236483|NCT01112436|Drug|none of medication preoperatively and intraoperatively|Patients in Group C wil receive none of medication preoperatively and intraoperatively
16236484|NCT01112423|Drug|BMS-823778|Capsules, Oral, 2 mg, once daily, 28 days
16236485|NCT01112423|Drug|BMS-823778|Capsules, Oral, 10 mg, once daily, 28 days
16236486|NCT01112423|Drug|BMS-823778|Capsules, Oral, 20 mg, once daily, 28 days
16236487|NCT01112423|Drug|Placebo|Capsules, Oral, 0 mg, once daily, 28 days
16236488|NCT01112410|Other|Hypertonic saline|"Hypertonic saline (6%) nebulised twice a day for 4 weeks.
~(Randomised crossover trial)"
16236489|NCT01112410|Other|Isotonic saline|Isotonic Saline (0.9%) nebulised twice a day for 4 weeks.
16236490|NCT01112397|Drug|AZD1480|continuous daily oral capsule
16236491|NCT01112384|Drug|SB939|Given orally 3 times per week
16236492|NCT01112371|Drug|Contractubex|"Contractubex® Gel, containing 10% extractum cepae, 1% allantoin and 50/U of sodium heparin per one gram of gel.
~Active drug group: The gel will be applied twice daily (morning/evening). Approximately 2 cm of the IMP are applied onto the scar by light massage rubbing carefully until the product is worked in."
16236493|NCT01112358|Drug|r-FSH|r-FSH will be administered as specified in the arm description.
16236494|NCT01112358|Drug|r-hLH|r-hLH will be administered as specified in the arm description.
16236495|NCT01112358|Drug|Analogous GnRH antagonist|Analogous GnRH antagonist will be administered as specified in the arm description.
16236496|NCT01112358|Drug|r-hCG|r-hCG will be administered as specified in the arm description.
16236497|NCT01112358|Drug|Progesterone|Progesterone will be administered as specified in the arm description.
16236541|NCT01111968|Biological|pandemic vaccine 10|3,75 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
16236498|NCT01112332|Device|SmartStep insole|Smart StepTM is an innovative biofeedback and monitoring system designed to help clinicians effectively guide patients with compromised lower limb function due to orthopedic or neurological trauma towards optimal gait performance. It records and analyzes key gait parameters and provides instantaneous and accurate audio and visual feedback.
16236499|NCT01112319|Device|Elf care|elfcare device
16236500|NCT01112319|Other|control group|regular physiotherapy treatment
16236501|NCT01112306|Drug|ACT-293987|Tablets, twice daily
16236502|NCT01112293|Drug|GC1008|GC1008 is a human IgG4 kappa monoclonal antibody capable of neutralizing all mammalian isoforms of TGFbeta (i.e., beta1, beta 2 and beta 3). GC1008 is a high affinity antibody with dissociation constants (Kds) of 1.8 nM, 2.8 nM and 1.4 nM for TGF1,2,and 3, respectively.
16236503|NCT01112280|Device|cap-assisted chromoendoscopy|A cap (irrigation cap) is a simple plastic device that can be attached to the tip of a colonoscope before performing the colonoscopy. For chromoendoscopy, 0.09% indigocarmine was administered via irrigation cap .
16236504|NCT01112267|Drug|Tramadol HCl/acetaminophen Extended Release|Participants will receive 1 tablet containing 75 mg of tramadol HCl and 650 mg of acetaminophen, once daily on Days 1to 3, then 1 tablet twice daily on Days 4 to 7
16236505|NCT01112267|Drug|Placebo|Participants will receive 1 matching placebo tablet once daily on Days 1 to 3, then 1 tablet twice daily on Days 4 to 7
16236506|NCT01112267|Drug|Tramadol HCl/acetaminophen Extended Release|Participants will receive 1 or 2 tablets containing 75 mg of tramadol HCl and 650 mg of acetaminophen, twice daily on Days 8 to 28
16236507|NCT01112267|Drug|Placebo|Prticipants will receive 1 or 2 matching placebo tablet once daily on Days 1 to 3, then 1 tablet twice daily on Days 8 to 28
16236508|NCT01112254|Procedure|MRI±biopsy|A MRI-guided or CT-guided preoperative biopsy will be performed in case of suspicious enhancement, multiple and large lesions (more than 3 cm for from the initial lesion), which is not viewed on the mammography or breast ultrasound. The surgery type will depends on the MRI +/- ± biopsy results.
16236509|NCT01112241|Drug|albuterol plus tiotropium|Four separate doses of 100 μg of albuterol and 18 μg of tiotropium bromide. Albuterol will be given by a metered-dose inhaler connected to a valved-holding chamber and tiotropium by a dry-powder device.
16236510|NCT01112228|Procedure|Bariatric surgery|Bariatric surgery: Gastric bypass, Sleeve gastrectomy, or Gastric banding
16236511|NCT01112215|Drug|Azathioprine|Initial dose of 2-2.5 mg/kg (according to TMTP levels) for 6 months according the severity of the flare with progressive tapering if complete remission has been obtained
16236512|NCT01112215|Drug|Enteric-Coated Mycophenolate Sodium|Initial dose of 1440 mg/day for 6 months to be tapered progressively if complete remission had been obtained
16236513|NCT01112189|Procedure|Autologous transplant|Patients will be stimulated 3 days with Filgrastrim 300 micrograms per day. On the 4th day the autologous transplant of stem cells will be performed.
16236514|NCT01112189|Other|Compressed sleeve treatment|"Week 1-2: With compressed sleeve treatment.
~Week 3 -4: Without treatment.
~Week 5 - 6: With compressed sleeve treatment"
16236515|NCT01112176|Procedure|Increase in paced heart rate|The pacing rate will be increased by 10 bps at every stage
16236516|NCT01112163|Device|Enhanced external counter pulsation|While an individual is undergoing ECP, they have pneumatic stockings (also known as cuffs) on their legs and are connected to telemetry monitors that monitor their heart rate and rhythm.The cuffs should ideally inflate at the beginning of diastole and deflate at the beginning of systole. During the inflation portion of the cycle, the calf cuffs inflate first, then the lower thigh cuffs and finally the upper thigh cuffs. Inflation is controlled by a pressure monitor, and the cuffs are inflated to about 300 mmHg.
16236517|NCT01112150|Device|NormaTec Pump|Normatec Pump
16236518|NCT01112137|Drug|Clopidogrel|
16236519|NCT01112137|Drug|Clopidogrel|
16236520|NCT01112137|Drug|Clopidogrel|
16236521|NCT01112137|Drug|Clopidogrel|
16236522|NCT01112111|Drug|mode of gonadotropin administration|Low dose step-up administration Step down administration sequential administration
16236523|NCT01112098|Behavioral|Patient Pamphlet|letter informs patient of opportunity to self-schedule a DXA scan; pamphlet includes information about receiving a DXA scan
16236524|NCT01112085|Drug|Ranibizumab 0.05mg|Intravitreal injections of 0.05mg ranibizumab over 6 months then additional treatment with ranibizumab 0.05mg as needed (according to re-treatment criteria)
16236525|NCT01112085|Drug|Ranibizumab 0.5mg|Intravitreal injections of 0.5mg ranibizumab over 6 months then additional treatment with ranibizumab 0.5mg as needed (according to re-treatment criteria)
16236526|NCT01112072|Drug|Riboflavin|Corneal epithelium removed followed by riboflavin drop administration every 2 minutes for 30 minutes followed by UV light exposure with additional riboflavin administration every 2 minutes for 30 minutes. Subjects will be randomized to receive Intacs placement either immediately before CXL or 3 months before CXL.
16236527|NCT01112059|Drug|Doxycycline|100 mg twice a day for 8 days
16236528|NCT01112059|Other|placebo|placebo
16236529|NCT01112046|Procedure|Endoscopic submucosal dissection|Endoscopic treatment (performed under conscious sedation) using specific endoscopic knives
16236530|NCT01112046|Procedure|Laparoscopic resection|Surgical treatment performed under general anesthesia
16236531|NCT01112020|Device|CHG Catheter Dressing Patch|2% CHG dressing applied to 7 sites
16236532|NCT01112020|Device|Biopatch|Biopatch applied to 7 sites
16236533|NCT01112020|Device|Tegaderm CHG|Tegaderm CHG IV Securement Dressing applied to 7 sites
16236534|NCT01111994|Drug|Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel|Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel QD for 3 months
16236535|NCT01111981|Drug|Clobetasol Propionate 0.05% Emollient Foam|Clobetasol Propionate 0.05% E Foam to be applied to affected area once a day for 16 weeks
16236536|NCT01111968|Biological|pandemic vaccine 1|7,5µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
16236537|NCT01111968|Biological|pandemic vaccine 2|3,75µg of A/H1N1 with MPLA adjuvant - IB, suspension (5µg) + Al(OH)3
16236538|NCT01111968|Biological|pandemic vaccine 5|7,5µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emulsion
16236539|NCT01111968|Biological|pandemic vaccine 6|3,75µg of A/H1N1 with MPLA adjuvant - IB, emultion (5µg) + Al(OH)3 + Squalene 2% emultion
16236540|NCT01111968|Biological|pandemic vaccine 9|7,5 µg of A/H1N1 with Al(OH)3 + Squalene 2% emultion
16236544|NCT01111968|Biological|pandmic vaccine 13|15µg of A/H1N1 with no adjuvant
16236545|NCT01111968|Biological|placebo group 14|All elements of the vaccine but antigen and adjuvant
16236546|NCT01111955|Drug|BMS-823778|Capsules, Oral, 2 mg, once daily, 28 days
16236547|NCT01111955|Drug|BMS-823778|Capsules, Oral, 10 mg, once daily, 28 days
16236548|NCT01111955|Drug|BMS-823778|Capsules, Oral, 20 mg, once daily, 28 days
16236549|NCT01111955|Drug|Placebo|Capsules, Oral, 0 mg, once daily, 28 days
16236550|NCT01111955|Drug|Metformin|Capsules, Oral, ≥ 1500 mg, once daily, 28 days
16236551|NCT01111942|Other|radiation combined with weekly carboplatin|"recommended premedications: Aloxi 0.25 mg IV; Dexamethasone 20 mg IV; Fosaprepitant 115 mg IV; Aprepitant 80 mg PO; Ativan 1.0 mg IV;
~Mucositis treatment should involve local measures to maintain oral hygiene, oral nystatin or fluconazole, or valacyclovir for viral infection.
~Induction Triple Therapy Treatment with TPF:
~Docetaxel (Taxotere) 75 mg/m2 IV; Cisplatin (Platinol) 100 mg/m2 IV; 1500 cc Normal Saline w/20meq KCL, 1 gram MgSo4 IV; 5-Fluorouracil (Adrucil) 1000 mg/m2 day IV-continuous infusion over 4 days; Neulasta* 6 mg SC Day 5 (*Neupogen may be substituted at the investigator's discretion)"
16236552|NCT01111942|Procedure|conservation surgery|Following induction triple chemotherapy, subjects will be restaged by physical examination and radiological imaging. If there is an absence of unequivocal evidence for residual disease (i.e. an apparent complete response), the subject will undergo conservation surgery under general anesthesia, using a transoral approach. Minimal tissue removal through direct access. The surgical specimen will be evaluated by a pathologist in the manner standard for the institution. The presence of residual tumor will be classified as a partial response to induction triple chemotherapy and the subject will undergo concomitant chemoradiotherapy. If there is no evidence of residual disease in the surgical specimen, the subject will be followed for recurrence.
16236553|NCT01111929|Drug|Counseling for LAM+ LNG-EC|"They will be provided by the above proper LAM counseling and contraceptive counseling. Additionally, they will be provided by EC pills and advised to use these pills if one of the prerequisites of LAM expires and sexual relation with their husband had occurred before the initiation of another long term contraceptive. Each women in this group will be supplied with one packet containing two 0.75 mg Levonorgestrel EC pills and advised to swallow the two tablets as soon as possible after having sexual intercourse with their husband after the expiry of LAM. They will be informed that they should not use the method after more than 5 days of having intercourse.
~They will be also advised not to use EC pills more than once. All women who have used the EC pills need to visit the clinic within few days of use for contraception advice. All the above information will be additionally given to the patient in a small flyer."
16236554|NCT01111903|Drug|Lenalidomide|Phase II: 20 mg/day in continuous regimen Phase I: 25 mg/day 21 days/28 with carboplatine AUC 5 + caelyx 30mg/m2
16236555|NCT01111890|Drug|Azarga (brinzolamide 1% / timolol 0.5%)|Dosed twice daily at 9:00 AM and 9:00 PM for 12 weeks
16236556|NCT01111890|Drug|Cosopt (dorzolamide 2% / timolol 0.5%)|Dosed twice daily at 9:00 AM and 9:00 PM for 12 weeks
16236557|NCT01111864|Dietary Supplement|fortification with iron and micronutrients|Iron 0 or 2.5 mg; Copper 0.34 mg; 30 µg Iodine; 7 µg Selenium; 2.5 mg Zinc; 100 µg Vitamin A; Vitamin D 5 µg; 5 mg Tocopherol Equivalent; 30 µg Vitamin K1; 10.5 mg Thiamine; 0.5 mg Riboflavin; 0.5 mg Pyridoxine; 90 µg Folic Acid Anhydrous; 6 mg Niacinamide; 60 mg Vitamin C; 0.9 µg Vitamin B12
16236558|NCT01111864|Dietary Supplement|Sprinkles|Daily 12.5mg Ferrous fumarate iron with microntrient is compared to no iron with micronutrients. Duration of intervention is 4 months, 80 infants will be inclulded.
16236559|NCT01111851|Drug|Fosaprepitant 150 mg|a single intravenous infusion of 150 mg fosaprepitant dimeglumine over 20 minutes on Day 1 15 minutes after consumption of a standard light breakfast meal
16236560|NCT01111851|Drug|Aprepitant 165 mg|a single oral 165 mg aprepitant capsule 15 minutes after consumption of a standard light breakfast meal
16236561|NCT01111851|Drug|Aprepitant 250 mg|a single oral 250 mg dose achieved by administering two 125 mg aprepitant capsules 15 minutes after consumption of a standard light breakfast meal
16236562|NCT01111851|Drug|Dexamethasone (12-8-16-16 mg)|Dexamethasone 12 mg will be administered orally 30 minutes after the start of fosaprepitant dimeglumine or 30 minutes after aprepitant on Day 1; Oral doses of dexamethasone will be administered on Day 2 (8 mg), Day 3 (8 mg twice daily), and Day 4 (8 mg twice daily) with or without a meal.
16236563|NCT01111851|Drug|Dexamethasone (12-8-8-16 mg)|Dexamethasone 12 mg will be administered orally 30 minutes after after aprepitant on Day 1; Oral doses of dexamethasone will be administered on Day 2 (8 mg), Day 3 (8 mg), and Day 4 (8 mg twice daily) with or without a meal.
16236564|NCT01111851|Drug|Ondansetron|The intravenous (I.V.) infusion of ondansetron 32 mg will begin 30 minutes after the start of fosaprepitant dimeglumine or 30 minutes after aprepitant on Day 1 and will be administered as a 15-minute infusion
16236565|NCT01111851|Drug|MK0999|I.V. infusion of MK0999 containing ~100 MBq (~3 mCi) containing ≤ 5 ug of MK0999)
16236566|NCT01111838|Drug|STA-9090|Patients will be enrolled and receive 200mg/m2 of STA-9090. Patients will receive single agent STA-9090 intravenous (I.V.) infusion (an indwelling catheter may not be used) over 60 minutes weekly (three weeks on and one week off). Follow-up imaging will be performed every 8 weeks to evaluate response.
16236567|NCT01111825|Drug|Temsirolimus|"28 day treatment cycle Phase 1
~Weekly intravenously (IV) on days 1, 8, 15, and 22
~Starting dose 8 mg IV weekly (dose level 1). Three patients initially enrolled in each cohort
~Phase 2
~Dose escalation cohort - 8 mg IV weekly on Days 1, 8, 15, and 22, and then 15 mg IV weekly starting on Day 29
~HER2-amplified and Triple negative - 8 mg IV weekly on Days 1, 8, 15, and 22"
16236568|NCT01111825|Drug|Neratinib|"28 day treatment cycle
~• 240 mg orally daily"
16236569|NCT01111799|Procedure|endometrial biopsy|two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.
16236570|NCT01111799|Procedure|endometrial biopsy|two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.
16236571|NCT01111799|Procedure|natural cycle + IUI + endometrial biopsy|two endometrial biopsies will be taken with a PIPELLE catheter on days 12 and 21 of the spontaneous menstrual cycle that precedes the fertility treatment.
16236686|NCT01110785|Other|laboratory biomarker analysis|
16236732|NCT01110486|Drug|ABT-348 and docetaxel|ABT-348 dosing will begin in Cycle 2. An oral dose of ABT-348 on Day 1 and Day 8; and an IV dose of docetaxel (75 mg/m2) on Day 1 of each 21-day cycle.
16236572|NCT01111773|Drug|Heated Lidocaine and Tetracaine Patch|Patients will apply one lidocaine 70 mg and tetracaine 70 mg topical patch to the affected knee twice daily for approximately 14 days. Patches will be applied morning and evening (applications separated by approximately 8-10 hours).
16236573|NCT01111747|Procedure|Platelet-rich plasma|Intra-operative use of platelet-rich plasma in the patellar tendon after harvesting its central third for ACL reconstruction.
16236574|NCT01111747|Procedure|Control group|In this group PRP will not be added to the patellar tendon donor site at the end of ACL reconstruction.
16236575|NCT01111734|Dietary Supplement|N-Acetylcysteine|All eligible study subjects will be treated with 600mg of N-Acetylcysteine orally twice a day for 2 weeks, then the dose will be increased to 1200mg twice a day for two weeks, and to 1800mg twice a day for 4 weeks.
16236576|NCT01111734|Drug|fMRI|All eligible subjects and controls will undergo an emotional face-viewing task in our fMRI paradigm in order to focus in on the circuitry related to affect processing.
16236577|NCT01111721|Behavioral|Project POWER HIV Risk-reduction Intervention|Nine session group-based behavioral intervention for incarcerated female adults.
16236578|NCT01111721|Behavioral|NC DOC Standard of Care for STIs|Standard North Carolina Department of Correction intake STI testing and counseling.
16236579|NCT01111708|Procedure|Close Rectal Dissection - IPAA|Comparison between conventional IPAA and Close Rectal IPAA and INRA after (sub)total proctocolectomy for Ulcerative colitis
16236580|NCT01111695|Device|ApisSept|honey and ionic silver based dressing
16236581|NCT01111682|Drug|Mannitol|0.9% normal saline infusion and boluses of mannitol
16236582|NCT01111682|Drug|Hypertonic Saline|3% hypertonic saline continuous infusion, with intermittent boluses as needed
16236583|NCT01111669|Drug|Tranexamic Acid|The bolus of TA is prepared according to patient weight (10mg / kg loading dose). The patients receiving placebo will receive an infusion of normal saline of the same volume of IV solution. Patients will receive the TA or saline infusion on call to the operating room, approximately 30 minutes before onset of the operation. The patients would also receive a continuous infusion of 1mg / kg per hour or TA preparation or normal saline for the duration of the operation.
16236584|NCT01111669|Drug|Normal Saline (placebo)|The patients receiving placebo will receive an infusion of normal saline of the same volume of IV solution. Patients will receive the saline infusion on call to the operating room, approximately 30 minutes before onset of the operation. The patients would also receive a continuous infusion of saline for the duration of the operation.
16236585|NCT01111656|Drug|Interferon beta-1b group|Patients receive interferon beta-1b 250ug subcutaneously every other day
16236586|NCT01111656|Drug|Interferon beta-1b/Atorvastatin group|Patients receive interferon beta-1b 250ug subcutaneously every other day AND atorvastatin 40mg every day (oral)
16236587|NCT01111643|Device|Echocardiogram|An echocardiogram will be repeated at every step, from baseline to peak heart rate setting.
16236588|NCT01111630|Drug|recomon (Epoetin Beta)|administer once weekly
16236589|NCT01111630|Drug|recomon (Epoetin Beta)|administer three times weekly
16236590|NCT01111617|Procedure|Real-time fMRI feedback|Patients receive real-time fMRI biofeedback to modulate pain
16236591|NCT01111604|Biological|Ramucirumab|8 mg/kg IV Q2W
16236592|NCT01111604|Biological|Icrucumab|15 mg/kg IV Q2W
16236593|NCT01111604|Drug|mFOLFOX-6|"Oxaliplatin: 85 milligram per square meter (mg/m²) IV every 2 weeks (Q2W)
~FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).
~5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W"
16236594|NCT01111591|Drug|Cox2 inhibitor (Celecoxib)|From postoperative third day, administration will be started celecoxib 200mg bid for 6 months for administration group.
16236595|NCT01111578|Device|Enteral feeding tube|The esophageal and gastric pressure, measured with this new device, will be recorded and compared with those ones measured with a standard esophageal catheter
16236596|NCT01111565|Drug|Escitalopram|Escitalopram monotherapy
16236597|NCT01111565|Drug|Aripiprazole|Aripiprazole monotherapy
16236598|NCT01111565|Drug|Aripiprazole/Escitalopram combination|Aripiprazole/Escitalopram combination therapy
16236605|NCT01111526|Drug|Panobinostat (LBH589)|"Phase I Initial Treatment Plan - Intravenous (IV) Formulation: Up to 4 dose levels (DL) of LBH589 IV formulation to establish LBH589 Maximum Tolerated Dose (MTD) in acute GVHD treatment. The first 4 participants began this treatment plan, before the IV Formulation became unavailable.
~DL -1: 1.25 mg/m^2 IV; DL 1: 2.5 mg/m^2 IV; DL 2: 5 mg/m^2 IV; DL 3: 7.5 mg/m^2 IV; DL 4: 10 mg/m^2 IV.
~Phase I Revised Treatment Plan - Oral Formulation (to replace IV Formulation): Dose escalation levels for LBH589; participants treated with LBH589 by mouth (PO) 3 times a week (48 hours apart) every week for 4 weeks.
~DL -1: 5 mg PO; DL 1: 10 mg PO (starting dose level); DL 2: 15 mg PO; DL 3: 20 mg PO; DL 4: 25 mg PO.
~Phase II Treatment Plan: LBH589 PO at MTD, 3 times a week (48 hours apart) every week for 4 weeks."
16236606|NCT01111513|Drug|48-hour ropivacaine infusions|Patients receive 20 ml of ropivacaine 0.5 % pre-operation through femoral block catheter, followed by ropivacaine infusions from 0.1 % to 0.1 ml/kg/hour for 48 hours.
16236607|NCT01111513|Drug|Single dose ropivacaine|Patients receive 20 ml of ropivacaine 0.5% pre-operation
16236608|NCT01111513|Drug|Patient controlled analgesics|Patient controlled analgesics alone, no femoral block
16236609|NCT01111500|Device|Donjoy ER brace|Patients will wear an external rotation brace, the Donjoy ER brace, during treatment.
16236610|NCT01111500|Device|Thoraco brachial brace|Patients will wear an internal rotation brace, a thoraco brachial brace, during treatment.
16236611|NCT01111487|Device|Expiratory positive airway pressure (EPAP) by face mask.|Implementation of the EPAP as group pressure, 10 or 15 cmH2O, for 20 minutes then evaluated the electromyographic activity of muscles and sternocleidomastoid parasternal the tenth and twentieth minutes of your application.
16236612|NCT01111474|Other|Cyanoacrylate|3 applications of cyanoacrylate (48 hours interval) at the cervical region of the sensitive tooth
16239897|NCT01086592|Other|No intervention|Daily life activities
16236613|NCT01111474|Radiation|Laser|This process was conducted three times with an interval of 48 hours between applications, according to laser's manufacturer advice Clean Line Easy Laser - LILT®, Clean Line Easy Laser Doctor Dental Products Industry LTDA, BRA). For dentin hypersensitivity, the application of 1Joule/cm^2 is recommended for eight seconds at three points along the dental neck, using the infrared wavelength (795nm).
16236614|NCT01111461|Drug|Lenvatinib|Lenvatinib 24 mg administered orally, once daily continuously in 28-day cycles to participants with advanced endometrial cancer and disease progression following first-line chemotherapy. Participants continued to receive study drug until disease progression, development of unacceptable toxicity or withdrawal of consent. 'Treatment interruption and subsequent dose reduction' was allowed for participants who experienced lenvatinib-related toxicity.
16236615|NCT01111448|Drug|Temsirolimus|25 mg/day 1; 8; 15; 22 of each 28-day cycle as intravenous infusion over 30 min
16236616|NCT01111422|Drug|N-acetylcysteine|N-acetylcysteine (200 mg/capsule) 1200 mg/day (600 mg bid) for 6 months
16236617|NCT01111409|Device|VFIX Device|Sterile, single-use instrument capable of delivering an absorbable PDS suture anchor
16236618|NCT01111383|Drug|tobramycin|"300mg/4ml solution, via a nebuliser, over a 48-week period in a twice-daily regimen, with 6 on cycles of 4 weeks duration during the 48-week period."
16236619|NCT01111370|Device|DexCom™ G4 Continuous Glucose Monitoring System|Continuous Glucose Monitoring System
16236620|NCT01111357|Biological|Collect of 10 ml of peripheric blood for DNA extraction|After signed written consent, all patients have a clinic exam in order to assess the presence of eligibility criteria (Patient with Rheumatoid Arthritis that fulfil the ACR criteria of diagnosis)
16236621|NCT01111344|Dietary Supplement|Glizigen + Viusid|"Glizigen (spray, 60 mL bottle with applicator): Dosage commensurate with surface (up to a maximum of 10 cm2) to be treated. From 3 to 5 ambulatory applications (One nebulization corresponds to 2 short pulses).
~1 to 3.9 cm2 ______________3 daily applications
~4 to 6.9 cm2 ______________4 daily applications
~7 to 10 cm2 ______________5 daily applications Treatment will last from 5 days to 8 weeks according to clinical improvement.
~Viusid (Syrop, 500 mL flask): 12.5 ml every 8 hours for 12 weeks. Viusid syrop should be dissolved in water, fruit juice or milk before ingestion."
16236622|NCT01111344|Dietary Supplement|Placebo|"Placebo Glizipen (spray, 60 mL bottle with applicator): Dosage commensurate with surface (up to a maximum of 10 cm2) to be treated. From 3 to 5 ambulatory applications (One nebulization corresponds to 2 short pulses).
~1 to 3.9 cm2 ______________3 daily applications
~4 to 6.9 cm2 ______________4 daily applications
~7 to 10 cm2 ______________5 daily applications Treatment will last from 5 days to 8 weeks according to clinical improvement.
~Placebo Viusid (Syrop, 500 mL flask): 12.5 ml every 8 hours for 12 weeks. Viusid syrop should be dissolved in water, fruit juice or milk before ingestion."
16236623|NCT01111331|Drug|BI 10773 25 mg|25 mg BI 10773 qd for 5 days
16236624|NCT01111331|Drug|Warfarin 25 mg|25 mg Warfarin single dose
16236625|NCT01111331|Drug|BI 10773 25 mg|25 mg BI 10773 qd for 12 days
16236626|NCT01111331|Drug|Warfarin|25 mg warfarin single dose with and without 50 mg BI 10773
16236627|NCT01111318|Drug|BI 10773|2 tablets BI 10773 25 mg single dose
16236628|NCT01111305|Drug|Reslizumab|
16236629|NCT01111305|Drug|Diethylcarbamazine|
16236630|NCT01111305|Other|Placebo|
16236631|NCT01111292|Drug|Inositol|Given PO
16236632|NCT01111292|Other|Placebo|Given PO
16236633|NCT01111279|Biological|gpASIT+TM|1 subcutaneous injection every 7 days, during 29 days.
16236634|NCT01111279|Biological|gpAST+TM/adjuvant|1 subcutaneous injection every 7 days, during 29 days
16236635|NCT01111279|Biological|Placebo solution|1 subcutaneous injection every 7 days, during 29 days
16236636|NCT01111266|Device|xevonta|"Patients will be treated with 3 different sizes of xevonta (2 weeks each size) for determination of in vivo KUF following FDA Guidance for the Content of Premarket Notifications for Conventional and High Permeability Hemodialyzers. In addition blood samples will be collected for determination of removal rates of different small molecules and protein."
16236637|NCT01111253|Drug|Amoxicillin-clavulanate|"Amoxicillin-clavulanate: 4 times a day 1200 mg and switch to oral administration 3 times a day 625 mg after two days, for a total duration of 10 days.
~In case of allergy to Amoxicillin-clavulanate: intravenous administration ciprofloxacin 2 times a day 400 mg and metronidazole 3 times a day 500 mg. In case of oral administration ciprofloxacin 2 times a day 500 mg and metronidazole 3 times a day 500 mg. For a total duration of 10 days."
16236638|NCT01111227|Drug|Propofol and isoflurane|Comparison of two anesthetic drugs
16236639|NCT01111214|Other|no intervention|There is no intervention. This is a non interventional study.
16236640|NCT01111201|Behavioral|questionnaires|The intervention is a self-administered anonymous questionnaire that is voluntarily completed by the patient. Questions in Section One will cover general information about the patient including gender, age, race, country of birth, current zip code of residence, and level of education. Questions in Section Two will cover information regarding the cancer (breast/lymphoma) or transplant (allogeneic/ autologous). Questions in Section Three will cover travel history including the frequency of travel outside the United States and Canada in the last 5 years. Questions in Sections Four through Seven will obtain information about their last trip outside the United States and Canada.
16236641|NCT01111188|Drug|PD 0332991|"PD 0332991 will be given on Days 1-12 followed by 9 days of non-treatment in a 21-day cycle. Dose will depend on dose escalation schedule.
~(-3a) 50 mg (-3) 50 mg (-2)75 mg (-1)75 mg (1)100 mg (2)125 mg (3)125 mg (3a)100 mg"
16236642|NCT01111188|Drug|bortezomib|"Given as intravenous bolus on days 8, 11, 15, and 18 of 21-day cycle. Dose depends on dose-escalation schedule.
~(-3a)1.0 mg/m2 (-3) 0.7 mg/m2 (-2) 0.7 mg/m2 (-1) 1.0 mg/m2 ( 1) 1.0 mg/m2 ( 2) 1.0 mg/m2 ( 3) 1.3 mg/m2 (3a)1.3 mg/m2"
16236643|NCT01111162|Biological|H1N1 vaccination|Novartis unadjuvanted inactivated S-OIV H1N1 influenza vaccine 15 mcg administered as single-0.5mL (15mcg) injection intramuscularly into one of the subject's deltoid muscles
16236644|NCT01111149|Other|Sugar Pill|Sugar pill created and masked by the pharmacy to be used as a control.
16236645|NCT01111149|Drug|Varenicline|Subjects in the varenicline group will receive one 1mg pill/day for week 0, followed by two 1mg pills/day for the rest of the study.
16236646|NCT01111149|Drug|Bupropion HCl|in the Bupropion HCl group will receive one 150mg pill/day for week 0, followed by two 150mg pills/day for the rest of the study
16236733|NCT01110486|Drug|ABT-348|An oral dose of ABT-348, twice daily on Day 1, Day 8, and Day 15 of each 28 day cycle
16236647|NCT01111136|Behavioral|Stress intervention|To evaluate psychological stress, participants will complete the Perceived Stress Scale, Beck Depression Inventory-Fast Screen, Anxiety Sensitivity Index-III, Posttraumatic Stress Diagnostic Scale and the Depression Anxiety Stress Scales; to evaluate cognitive and behavioral aspects of emotional avoidance, participants will complete the Emotional Avoidance Questionnaire as well as the Acceptance and Action Questionnaire, Difficulties in Emotion Regulation Scale, Illness Attitudes Scale and the Five Facet Mindfulness Questionnaire; and to evaluate quality of life in regards to his/her skin condition, participants will complete the Dermatology Life Quality Index questionnaire.
16236648|NCT01111123|Drug|Lac-Hydrin lotion (ammonium lactate lotion 12%) ; UItravate ointment (halobetasol propionate ointment 0.05%)|Steroid on weekends only group
16236649|NCT01111123|Drug|Lac-Hydrin lotion (ammonium lactate lotion 12%); placebo ointment|Placebo on weekends only group
16236650|NCT01111110|Device|anti-static then static|Albuterol using static chambers
16236651|NCT01111110|Device|Static then anti-static chamber|albuterol with Static then anti-static chambers
16236652|NCT01111097|Drug|Dichloroacetate|Subjects after passing the inclusion criteria are given a dose of dichloroacetate 4mg/kg bid for thirty days. While in the clinical research center they participate in a breath test where they exhale through a straw into a glass tube. This will measure CO2. They are monitored every two weeks for side effects and return to the clinical research center for evaluation in thirty days. They undergo another breath test and if all health parameters are within normal limits they are given a month's supply of dichloroacetate. The cycles continue unless a serious adverse event occurs or the PI judges the side effects preclude another 30 days of medication
16236653|NCT01111084|Drug|Follitropin alpha (r-FSH)|The dosage and administration of follitropin alpha was according to each centre's protocol and within technical specification recommendations.
16236654|NCT01111058|Drug|Everolimus (RAD 001)|10mg of Everolimus or Placebo taken by mouth once daily for 1 year or until progression (whichever comes first).
16236655|NCT01111058|Other|Placebo|
16236656|NCT01111045|Drug|Bone morphogenetic protein 7|Comparison of different doses of the drug via single intraarticular knee injection
16236657|NCT01111045|Drug|Placebo|Placebo
16236658|NCT01111019|Drug|Recombinant human growth hormone (r-hGH)|Subjects will receive a single subcutaneous injection of recombinant human growth hormone (r-hGH) equivalent to a dose of 0.057 milligram per kilogram per day (mg/kg/day). The dose will be subsequently adjusted during the trial and subjects will be treated for at least 3 years or until near final height is reached.
16236659|NCT01111006|Device|Bidet (electronic cleansing toilet system)|The volunteers underwent rectal examinations and baseline manometry at lateral decubitus position. Subjects were then placed on a toilet with Bidet attached and manometry catheter was inserted and fixed placing the channels of the catheter at the high pressure zone (HPZ) of the anal canal. Anorectal pressures were measured before and after using the Bidet under different water pressures (4, 8, 16, 20 gram force, gf), types of water stream (narrow vs. wide), and different temperatures (24oC vs. 38oC).
16236660|NCT01110980|Other|Swallow therapy in combination with individual dietary counselling|Weekly swallowing therapy (by speech language therapist) from start of (chemo)radiation until 6 months after last (chemo)radiation. Weekly Individual dietary counselling (by dietician) form the start of (chemo) radiotherapy until 6 months after last (chemo)radiation. With close interaction between the both interventions.
16236661|NCT01110980|Other|Individual dietary counselling|Weekly Individual dietary counselling form the start of (chemo) radiotherapy until 6 months after last (chemo)radiation.
16236662|NCT01110954|Drug|PD L 506|Two different doses will be compared
16236663|NCT01110941|Drug|S-1, leucovorin, oxaliplatin|S-1(20mg、25mg), capsule, 40~60mg, Bid,p.o., day1~7； LV (25 mg), tablet, 25mg,Bid,p.o., day1~7； L-OHP (50 mg),injection 85mg/m2, day1. repeated at every 2 weeks cycle till disease progression.
16236664|NCT01110928|Drug|somatropin|Norditropin® (somatropin) prescribed at the discretion of the physician according to normal clinical practice. Safety and effectiveness data is recorded by the physician, at study initiation and every 6 months until last visit.
16236665|NCT01110915|Device|Medtronic Advisa MRI Implantable Pulse Generator (IPG)|Advisa MRI IPG is a dual chamber, multi-programmable IPG indicated to restore heart rates, improve cardiac output, prevent symptoms, or protect against arrhythmias related to cardiac impulse formation or conduction disorders. The IPG is indicated for use in patients who may benefit from rate-responsive pacing to support cardiac output during varying levels of activity and has been modified for use during an MRI exam.
16236666|NCT01110915|Device|Medtronic CapSureFix MRI™ active fixation MRI lead|The Medtronic CapSureFix MRI™ active fixation MRI lead is a transvenous, bipolar, silicone, steroid eluting and active fixation pacing lead. It is based on the commercially available Medtronic Model 5076 lead and has been modified for use in the MRI environment. The MRI lead is used for both atrial and ventricular applications.
16236667|NCT01110902|Drug|Agomelatine (AGO178C)|
16236668|NCT01110902|Drug|Placebo|
16236669|NCT01110889|Drug|Agomelatine (AGO178C)|
16236670|NCT01110889|Drug|Agomelatine (AGO178C)|
16236671|NCT01110889|Drug|Placebo|
16236672|NCT01110876|Drug|Vorinostat|"Phase I Starting Dose: 200 mg twice daily by mouth on Days 1-7, 15-21 of each 28 day cycle.
~Phase II Dose: MTD from Phase I."
16236673|NCT01110876|Drug|Erlotinib|"Phase I Starting Dose: 200 mg by mouth daily on Days 1-21 of 28 day cycle. For patients on enzyme inducing anticonvulsants (EIACs), starting dose of 400 mg.
~Phase II Dose: MTD from Phase I."
16236674|NCT01110876|Drug|Temozolomide|125 mg/m2 by mouth daily on days 1-7, 15-21 of each 28 day cycle.
16236675|NCT01110837|Other|Allergen|Allergen nasal challenge
16236676|NCT01110837|Other|Placebo challenge|Placebo nasal challenge
16236677|NCT01110824|Drug|Enalapril and carvedilol|Enalapril 2.5 to 10 mg BID Carvedilol 6.25 to 25 mg BID
16236678|NCT01110811|Procedure|Transoral Incisionless Fundoplication (TIF)|The TIF procedure results in the creation of an esophago-gastric fundoplication extending up to 4 cm above the Z-line and 270 degress around the esophagus.
16236679|NCT01110798|Other|intraoperative complication management/prevention|
16236680|NCT01110798|Procedure|assessment of therapy complications|
16236681|NCT01110798|Procedure|gastrointestinal complications management/prevention|
16236682|NCT01110798|Procedure|quality-of-life assessment|
16236683|NCT01110798|Procedure|therapeutic conventional surgery|
16236684|NCT01110785|Biological|panitumumab|
16236687|NCT01110772|Device|2-octyl cyanoacrylate [InteguSEAL®]|At operating room arrival prior to surgery, povidone-iodine is applied on the skin surface on concentric circles as recommended; after drying, the cyanoacrylate device is opened and a layer of the sealant is applied on the incision and skin site(IS100 for patients undergoing mastectomy, and IS200 for patients undergoing gynecologic or digestive tract surgeries).
16236688|NCT01110772|Device|Iodine povacrylex in isopropyl alcohol [Duraprep®, 3M]|At the operating room arrival a few minutes before the incision, cleansing and skin antisepsis is done with the prefilled device with iodine povacrylex in isopropyl alcohol as recommended by 3M.
16236689|NCT01110746|Drug|Viaject 7|100IU/mL administered subcutaneously
16236690|NCT01110746|Drug|LISPRO|100IU/mL administered subcutaneously
16236691|NCT01110720|Drug|Davunetide|Davunetide Nasal Spray 30 mg BID IN 52 weeks
16236692|NCT01110720|Drug|Placebo|Placebo Nasal Spray BID IN 52 weeks
16236693|NCT01110707|Drug|Recombinant human follicle stimulating hormone (r-hFSH)|Subjects will receive subcutaneous injection of recombinant human follicular stimulating hormone (r-hFSH) 300-450 International Units (IU) administered after pituitary desensitization according to the ovarian response with gonadotrophin-releasing hormone agonist (GnRH-a; at a dose of 0.1 milligram per day [mg/day]).
16236694|NCT01110707|Drug|Recombinant human luteinizing hormone (r-hLH)|Subjects will receive subcutaneous injection of recombinant human luteinizing hormone (r-hLH) 150 IU/day until the end of ovarian stimulation.
16236695|NCT01110681|Device|Solesta (Dextranomer in gel of stabilized non-animal hyaluronate)|
16236696|NCT01110668|Drug|Nilotinib|
16236697|NCT01110655|Other|Intravenous hypertonic Saline|Intravenous 100mL bolus of 3% saline
16236698|NCT01110655|Other|Oral hypertonic saline|Oral 100mL bolus of 3% saline
16236699|NCT01110642|Drug|Lovastatin|Topical lovastatin applied to red, rashy areas two times daily for 12 months
16236700|NCT01110629|Drug|Fosrenol (Lanthanum Carbonate, BAY77-1931)|Daily dose: 750-2250mg 3 times a dayfor 8 weeks.
16236701|NCT01110629|Drug|Placebo|daily dose: 3 tablets TID for 8 weeks.
16236702|NCT01110616|Drug|MK3134|MK3134, 25 mg tablets (5 x 5 mg capsule), orally
16236703|NCT01110616|Drug|Comparator: Lorazepam|Lorazepam, 2 mg (2 x 1 mg tablet), orally
16236704|NCT01110616|Drug|Comparator: Placebo|Placebo, to match MK3134, and placebo to match Lorazepam
16236705|NCT01110603|Drug|MK-4827|Capsules, orally, once daily, on Days 1 and 3 of each 21- or 28-day Cycle, at the assigned dose level, starting at 40 mg per dose.
16236706|NCT01110603|Drug|carboplatin|Intravenous infusion, at AUC 5, once, on Day 3 of each 21- or 28-day cycle
16236707|NCT01110603|Drug|paclitaxel|Intravenous infusion, 175 mg/m2, once, on Day 3 of each 21-day cycle
16236708|NCT01110603|Drug|liposomal doxorubicin|Intravenous infusion, 30 mg/m2, once, on Day 3 of each 28-day cycle
16236709|NCT01110590|Drug|BAY60-4552 + Vardenafil|Total dose given over 14 days: 5.25 mg BAY60-4552 + 140 mg Vardenafil
16236710|NCT01110590|Drug|BAY60-4552 + Vardenafil|Total dose given over 14 days: 21.0 mg BAY60-4552 + 140 mg Vardenafil
16236711|NCT01110590|Drug|BAY60-4552 + Vardenafil|Total dose given over 14 days: 21.0 mg BAY60-4552 + 280 mg Vardenafil
16236712|NCT01110590|Drug|Placebo|Placebo
16236713|NCT01110551|Drug|Placebo (SC)|Phosphate buffered saline administered subcutaneously.
16236714|NCT01110551|Drug|Placebo (ID)|Phosphate buffered saline administered intradermally.
16236715|NCT01110551|Biological|Modified Live Tetravalent Chimeric Dengue Vaccine (SC)|DENVax is a tetravalent dengue vaccine comprised of four recombinant, live attenuated dengue virus strains: DEN-2 PDK-53 (DENVax-2), DEN-2/1 chimera (DENVax-1), DEN-2/3 chimera (DENVax-3) and DEN-2/4 chimera (DENVax-4). The drug product is formulated in buffer and stored frozen. Low dose contains (dose volume 0.1 mL): D1: 8 x 10^3, D2: 5 x 10^3, D3: 1 x 10^4, and D4: 2 x 10^5, total virus dose [plaque forming units (PFU)]: 2.2 x 10^5. High dose contains (dose volume 0.1 mL): D1: 2 x 10^4, D2: 5 x 10^4, D3: 1 x 10^5, and D4: 3 x 10^5, total virus dose (PFU): 4.7 x 10^5. DENVax administered subcutaneously.
16236716|NCT01110551|Biological|Modified Live Tetravalent Chimeric Dengue Vaccine (ID)|DENVax is a tetravalent dengue vaccine comprised of four recombinant, live attenuated dengue virus strains: DEN-2 PDK-53 (DENVax-2), DEN-2/1 chimera (DENVax-1), DEN-2/3 chimera (DENVax-3) and DEN-2/4 chimera (DENVax-4). The drug product is formulated in buffer and stored frozen. Low dose contains (dose volume 0.1 mL): D1: 8 x 10^3, D2: 5 x 10^3, D3: 1 x 10^4, and D4: 2 x 10^5, total virus dose [plaque forming units (PFU)]: 2.2 x 10^5. High dose contains (dose volume 0.1 mL): D1: 2 x 10^4, D2: 5 x 10^4, D3: 1 x 10^5, and D4: 3 x 10^5, total virus dose (PFU): 4.7 x 10^5. DENVax administered intradermally.
16236717|NCT01110525|Drug|AZD1981|4X100 mg per oral, twice daily for 28 days
16236718|NCT01110525|Drug|Neovletta 21/28|Once daily with (21) or without (28) pause for bleeding.
16236719|NCT01110525|Drug|Placebo AZD1981|4X100 mg per oral, twice daily for 28 days
16236720|NCT01110512|Drug|Flavonid|"Diosmin (450 mg) + hesperidin (50 mg)
~1 tablet, 2 times per day."
16236721|NCT01110512|Drug|Daflon|"Diosmin (450 mg) + hesperidin (50 mg)
~1 tablet, 2 times per day"
16236722|NCT01110499|Drug|AGN-210961 Formulation 1|AGN-210961 Formulation 1 in one eye once daily for 7 days.
16236723|NCT01110499|Drug|AGN-210961 Formulation 2|AGN-210961 Formulation 2 in one eye once daily for 7 days.
16236724|NCT01110499|Drug|AGN-210961 Formulation 3|AGN-210961 Formulation 3 in one eye once daily for 7 days.
16236725|NCT01110499|Drug|AGN-210961 Formulation 4|AGN-210961 Formulation 4 in one eye once daily for 7 days.
16236726|NCT01110499|Drug|AGN-210961 Formulation 5|AGN-210961 Formulation 5 in one eye once daily for 7 days.
16236727|NCT01110499|Drug|AGN-210961 Formulation 6|AGN-210961 Formulation 6 in one eye once daily for 7 days.
16236728|NCT01110499|Drug|AGN-210961 Formulation 7|AGN-210961 Formulation 7 in both eyes once daily for 4 weeks.
16236729|NCT01110499|Drug|bimatoprost ophthalmic solution 0.03%|bimatoprost ophthalmic solution 0.03% (LUMIGAN®) in both eyes once daily for 4 weeks.
16236730|NCT01110486|Drug|ABT-348|An oral dose of ABT-348, once daily on Day 1, Day 8, and Day 15 of each 28 day cycle.
16236731|NCT01110486|Drug|ABT-348 and carboplatin|An oral dose of ABT-348 will begin in Cycle 2on Day 1 and Day 8; and an IV dose of carboplatin (AUC 5.0) on Day 1 of each 21-day cycle.
16236734|NCT01110486|Drug|ABT-348|An IV administration of ABT-348 two hour infusion on Day 1, Day 8 and Day 15 of each 28 day cycle.
16236735|NCT01110473|Drug|ABT-348|An oral dose of ABT-348, once daily on Day 1, Day 8, and Day 15 of each 28 day cycle.
16236736|NCT01110473|Drug|ABT-348|An oral dose of ABT-348, twice daily on Day 1, Day 8, and Day 15 of each 28 day cycle
16236737|NCT01110473|Drug|ABT-348 and azacitidine|An oral dose of ABT-348 on Day 1, Day 8, and Day 15 of each 28 day cycle. An IV or injection of azacitidine on Days 1-7 of each 28 day cycle.
16236738|NCT01110473|Drug|ABT-348|An intravenous dose of ABT-348, once daily on Day 1, Day 8, and Day 15 of each 28 day cycle.
16236739|NCT01110447|Drug|VSL#3|VSL#3® is made up of 4 strains of Lactobacilli (L. paracasei, L. plantarum, L. acidophilus and L. delbrueckii subsp. bulgaricus), 3 strains of Bifidobacteria (B. longum, B. infantis, B. breve) and 1 strain of Streptococcus thermophilus. Dose would be 1 sachet per day (Each sachet containing 900 Billion CFU). The duration of treatment would be for 24 weeks
16236740|NCT01110447|Other|Placebo|Placebo sachets contain corn starch. Dose: 1 sachet per day Duration of treatment: 24 weeks
16236741|NCT01110434|Drug|Topiramate|Topiramate (200 mg daily)
16236742|NCT01110434|Drug|Placebo|Placebo (daily)
16236743|NCT01110421|Drug|Cefepime placebo|Form=solution for infusion, Route=intravenous use, administered once every 8 hours infused over 30 minutes immediately before each iv infusion of doripenem for up to 14 days
16236744|NCT01110421|Drug|Cefepime|Type=once every 8 hours, Unit=mg, Number=50 mg/kg up to 2g/dose, Form=solution for infusion, Route=intravenous use. At least 3 days of iv cefepime administered every 8 hours infused over 30 minutes immediately before each iv infusion of doripenem placebo for up to 14 days
16236745|NCT01110421|Drug|Doripenem|Type=once every 8 hours infused over 60 minutes, Unit=mg, Number=20mg/kg up to 500mg/dose, Form=solution for infusion, Route=intravenous use. At least 3 days of iv doripenem administered every 8 hours immediately after each iv infusion of cefepime placebo for up to 14 days
16236746|NCT01110421|Drug|Doripenem placebo|Form=solution for infusion, Route=intravenous use, administered once every 8 hours infused over 60 minutes immediately following each iv infusion of cefepime for up to 14 days
16236747|NCT01110421|Drug|Amoxicillin/clavulanate potassium|Form=suspension or tablets, Route=oral (by mouth), may be administered at the discretion of the investigator once every 12 hours for up to 14 days following IV therapy with doripenem or cefepime.
16236748|NCT01110408|Drug|Doripenem|Type=once every 8 hours infused over 60 minutes, Unit=mg,Number=20mg/kg up to 500mg/dose, Form=solution for infusion,Route=intravenous use. At least 3 days of iv doripenem administered every 8 hours immediately after each iv infusion of cefepime placebo for up to 14 days
16236749|NCT01110408|Drug|Doripenem placebo|Form=solution for infusion, Route=intravenous use, administered once every 8 hours infused over 60 minutes immediately following each iv infusion of cefepime for up to 14 days
16236750|NCT01110408|Drug|Cefepime|Type=once every 8 hours, Unit=mg, Number=50 mg/kg up to 2g/dose, Form=solution for infusion, Route=intravenous use. At least 3 days of iv cefepime administered every 8 hours infused over 30 minutes immediately before each iv infusion of doripenem placebo for up to 14 days
16236751|NCT01110408|Drug|Cefepime placebo|Form=solution for infusion, Route=intravenous use, administered once every 8 hours infused over 30 minutes immediately before each iv infusion of doripenem for up to 14 days
16236752|NCT01110408|Drug|Amoxicillin/clavulanate potassium|Form=suspension or tablets, Route=oral (by mouth), may be administered at the discretion of the investigator once every 12 hours for up to 14 days following IV therapy with doripenem or cefepime.
16236753|NCT01110395|Diagnostic Test|MR Spectroscopy|MR spectroscopy of myocardial
16236754|NCT01110382|Drug|Doripenem|Type=once every 8 hours infused over 60 minutes, Unit=mg, Number=20mg/kg up to 500mg/dose, Form=solution for infusion, Route-intravenous use. At least 3 days of iv doripenem administered every 8 hours immediately after meropenem placebo for up to 14 days
16236755|NCT01110382|Drug|Meropenem placebo|Form=solution for infusion, Route=intravenous use, administered once every 8 hours infused over 30 minutes immediately before each iv infusion of doripenem for up to 14 days.
16236756|NCT01110382|Drug|Meropenem|Type=once every 8 hours infused over 30 minutes, Unit=mg, Number=20 mg/kg to 1 gram per dose, Form=solution for infusion, Route=intravenous use. At least 3 days of iv meropenem administered every 8 hours immediately before doripenem placebo for up to 14 days
16236757|NCT01110382|Drug|Doripenem placebo|Form=solution for infusion, Route=intravenous use, administered once every 8 hours infused over 60 minutes immediately after each iv infusion of meropenem for up to 14 days
16236758|NCT01110382|Drug|Amoxicillin/clavulanate potassium|Form=suspension or tablets, Route=oral (by mouth), may be administered at the discretion of the investigator once every 12 hours for up to 14 days following IV therapy with doripenem or meropenem.
16236759|NCT01110369|Dietary Supplement|Protein drink|Protein drink twice a day during 6 months.
16236760|NCT01110369|Other|Resistance exercise training|Resistance exercise training twice per week during 6 months.
16236761|NCT01110369|Dietary Supplement|Placebo drink|Placebo drink twice a day during 6 months.
16236762|NCT01110356|Drug|Ferinject|Ferric carboxymaltose will be provided in 2 vials of 10 mL containing each 500 mg iron, which will be diluted in 250 mL normal saline for injection. Study drug will be administered by drip infusion immediately after preparation over a minimum of 15 minutes. Placebo patients will be administered 250 mL normal saline for injection over a minimum of 15 minutes.
16236763|NCT01110356|Other|Saline|Placebo patients will be administered 250 mL normal saline for intravenous drip over a minimum of 15 minutes.
16236764|NCT01110343|Behavioral|mindfulness intervention|a 6 -week behavioral intervention lasting 1.5 hours per week with a trained parent mentor, 3 monthly booster sessions and follow-up
16236765|NCT01110343|Behavioral|Conventional parent Support Group|a 6 week behavioral program, consisting of 1.5 hour weekly sessions run by a trained parent mentor with a structured curriculum based on the strengths of support groups like emotional support, advocacy and training. There are 3 monthly booster sessions and follow-up.
16236766|NCT01110330|Drug|Placebo cream|A topical, white, homogenous cream identical in appearance to study drug applied sparingly to all affected areas of the foot (or feet), once daily (at night or in the evenings) for a total of 4 weeks.
16236767|NCT01110330|Drug|Ketoconazole 2% cream (formulation F012) (Nizoral)|A topical, white, homogenous cream containing the equivalent of 20 mg (or 2%) of ketoconazole identical in appearance to study drug applied sparingly to all affected areas of the foot (or feet), once daily (at night or in the evenings) for a total of 4 weeks.
16240034|NCT01085591|Drug|Vancomycin|
16236768|NCT01110330|Drug|Ketoconazole 2% cream (formulation F126)|A topical, white, homogenous cream containing the equivalent of 20 mg (or 2%) of ketoconazole applied sparingly to all affected areas of the foot (or feet), once daily (at night or in the evenings) for a total of 4 weeks.
16236769|NCT01110317|Drug|paliperidone palmitate 100 mg|Patients will receive a single paliperidone palmitate 100 mg equivalent injection in the gluteal or deltoid muscle on Day 1, 8, 36, and 64.
16236770|NCT01110304|Other|Conservative treatment - brace|Patients selected for this treatment will wear a light brace for pain release and analgesics will be prescribed. They can move the elbow, the wrist and the fingers immediately. After two weeks, they will begin a training program to restore shoulder motion and strength, and they will be asked to take off the brace progressively. They are allowed to start working and sporting activities when they feel comfortable.
16236771|NCT01110304|Device|Hook plate by Synthes|The patient is in a beach-chair position with injured arm slightly out of the table, on a bracket. The incision is longitudinal, from the distal third of the clavicle to the lateral border of the acromion. The deltoid is detached anteriorly to present the clavicle and the AC joint. The width of the hook depends on the depth of the acromion. The plate will always be 5 holes 3.5mm hook plate (Synthes®), left or right. The hook is inserted after visual reduction of the AC joint at the posterior border of the distal end of the clavicle, under the acromion. Reduction is then maintained by a davier and fixation with three 3,5mm cortical screws is achieved. After washing, deltoid is reinserted. CC ligaments are not directly repaired. Wound closure and bracing for two weeks.
16236772|NCT01110291|Drug|docetaxel + CEF|"Docetaxel 80 mg/m² of body surface area (BSA) will be given as an i.v. infusion during 60 minutes on day 0 in a 20-day schedule. The cycle is repeated three times.
~Three weeks after the last docetaxel regimen, all patients will receive the CEF-combination treatment. In CEF-combination cyclophosphamide will be given 600 mg/m²of BSA as an i.v. infusion during 15 - 30 minutes on day 0 in a 20-day schedule. This is followed by fluorouracil given 600 mg/m² of BSA as an i.v. infusion during 15 - 30 minutes . Epirubicin will be given 60 mg/m² of BSA as an i.v. infusion during 15 - 30 minutes. This combination therapy will be repeated three times."
16236773|NCT01110265|Behavioral|attention training|
16236774|NCT01110265|Behavioral|placebo training|
16236775|NCT01110252|Drug|Stem cells stimulation|Subcutaneous injection of 5mcg/kg of G-CSF 3 days before the procedure.
16236776|NCT01110252|Procedure|stem cells collection|pullout of 200ml of bone marrow through the puncture of the iliac crest
16236777|NCT01110252|Genetic|stem cells infusion|slow infusion through the brachial vein of 30ml of bone marrow mononuclear cells diluted in albuminous saline.
16236778|NCT01110239|Procedure|remote limb preconditioning|3 cycles of up to 10 minutes leg ischemia
16236779|NCT01110226|Drug|KML-001|"KML001 will begin given to patients first. It should be taken by mouth immediately prior to cisplatin infusion. Patients will be treated in cohorts of three beginning at 15mg. The Dose will be increased until Maximum Tolerated Dose is established.
~KML001 will be administered daily for 14 days of a 21 day cycle. Patients will have one week off."
16236780|NCT01110226|Drug|Cisplatin|Cisplatin will be given to all patients at a dose of 75 mg/m2 on day 1 of every 21 day cycle over 30 to 90 minutes through an intravenous infusion immediately after the first dose of KML-001
16236781|NCT01110213|Behavioral|Physical activity|Participants received two individually tailored phone calls and two condition specific newsletters encouraging goal setting and weighing the pros and cons for physical activity.
16236782|NCT01110213|Behavioral|Fruit and vegetable|Participants received two individually tailored phone calls and two condition specific newsletters encouraging goal setting and weighing the pros and cons for fruit and vegetable consumption.
16236783|NCT01110200|Drug|ADVAIR DISKUS 250/50 mg BID|Fluticasone propionate/salmeterol 250/50 mcg BID in the DISKUS formulation (ADVAIR DISKUS) is a combination product containing a corticosteroid and a long-acting beta2-adrenergic agonist, indicated in the US for the maintenance treatment of airflow obstruction and reducing exacerbations in patients with COPD.
16236784|NCT01110200|Drug|SEREVENT 50 mcg BID|Salmeterol xinafoate Inhalation Powder (SEREVENT DISKUS) is indicated for the long-term, twice-daily (morning and evening), administration in the maintenance treatment of bronchospasm associated with COPD (including emphysema and chronic bronchitis).
16236785|NCT01110187|Drug|lacosamide|200 mg IV over 60 minutes; these patients will then be started on a maintenance dose 100 mg, IV BID as prophylaxis administered as per pharmacy protocol consistent with acceptable standards of care for 7 days. The Lacosamide dose can be adjusted as needed if seizures occur for therapeutic effect up to 200 mg bid (400 mg/d) as a maximum dose.
16236786|NCT01110187|Drug|Fosphenytoin|20 mgPE/kg IV over 60 minutes and then will be started on a maintenance dose (5 mgPE/kg/day, rounded to nearest dose of 150 mgPE IV, BID administered as per pharmacy protocol consistent with acceptable standards of care for 7 days
16236787|NCT01110174|Diagnostic Test|HD PET/CT|imaging
16236788|NCT01110161|Device|Visceral fat mass measurement|Total body DXA measurement, Abdominal CT scan
16236789|NCT01110148|Other|video-based informed consent for skin biopsies|video-based informed consent for punch and shave biopsies
16236790|NCT01110148|Other|traditional informed consent|traditional informed consent (standard of care) from physicians for shave and punch biopsies
16236791|NCT01110135|Drug|bendamustine hydrochloride|Given IV
16236792|NCT01110135|Drug|dexamethasone|Given PO
16236793|NCT01110135|Biological|filgrastim|Given SC
16236794|NCT01110135|Procedure|leukapheresis|Given IV
16236795|NCT01110135|Other|laboratory biomarker analysis|Correlative studies
16236796|NCT01110135|Other|flow cytometry|Correlative studies
16236797|NCT01110135|Drug|etoposide|Given IV
16236798|NCT01110122|Dietary Supplement|Whey protein|20g, oral, dissolved in yoghurt-drink, after every training and match for 2 weeks
16236799|NCT01110096|Behavioral|Parent Management Training - Oregon (PMTO)|Method to help parents and caregivers manage the behavior of the children they are responsible for.
16236800|NCT01110096|Behavioral|Motivational interviewing|Communication method to facilitate behavioral change and empower the parents.
16236801|NCT01110096|Behavioral|Dynamic group therapy|Focuses on individual experiences within families and/or parents/children, and that the participants are their own experts.
16236802|NCT01110083|Drug|EMD 1204831|Subjects will receive EMD 1204831 twice a day for 21 days during each treatment cycle
16240190|NCT01084278|Drug|Colchicine|Colchicine tablets
16236803|NCT01110070|Device|ChonDux|Comparison of ChonDux plus microfracture to microfracture only
16236804|NCT01110070|Device|ChonDux|single use device
16236805|NCT01110057|Drug|Placebo|Placebo to match GW856553
16236806|NCT01110057|Drug|GS856553|GW586553 7.5mg bid
16236807|NCT01110044|Biological|251154 vaccine|Intramuscular, single dose
16236808|NCT01110044|Biological|Infanrix hexa™|Intramuscular, four doses
16236809|NCT01110044|Biological|Synflorix™|Intramuscular, four doses
16236810|NCT01110044|Biological|Rotarix™|Oral, two doses
16236811|NCT01110031|Biological|Ofatumumab|Anti-CD20 monoclonal antibody
16236812|NCT01110018|Drug|GSK573719 (SOLUTION)|20μg /mL solution for IV and Oral dosing
16236813|NCT01110018|Drug|GSK573719 (INHALATION POWDER)|500μg inhalation powder delivered via Novel Dry Powder Inhaler. GSK573719 1000μg per dose (2x 500μg strips in device).
16236814|NCT01110005|Other|D5 Lactated Ringer's Solution (D5LR)|D5LR IV fluid
16236815|NCT01110005|Other|Lactated Ringer's Solution (LR)|LR IV fluid
16236816|NCT01109992|Drug|Exercise plus Regadenoson (Lexercise)|Standard Bruce exercise stress test with regadenoson injection at maximal stress with Rubidium-82 Positron Emission Tomography
16236817|NCT01109992|Drug|Regadenoson (Lexiscan)|Regadenoson Rubidium-82 Positron Emission Tomography
16236818|NCT01109979|Drug|Estradiol+MPA|1 single pill dose daily containing estradiol 1 mg + medroxyprogesterone acetate 2.5 mg
16236819|NCT01109979|Drug|Estradiol+Drospirenone|1 single pill dose daily containing estradiol 1mg + drospirenone 0.5 mg
16236820|NCT01109966|Other|Special Medical Food|"Comparison between a standard amino acid based formula and a new amino acid based formula. Subjects with CMA will take their randomised formula for 12 months. Following completion of the intervention (12 months), subjects will transfer to an age appropriate formula and be followed-up at 24 and 36 months.
~Infants should typically consume the following amounts of formula during the study > 500mls/day up to 12 months of age > 400mls/day between 12 and 18 months of age > 300mls/day over 18 months of age."
16236821|NCT01109966|Other|Special Medical Food|"Comparison between a standard amino acid based formula and a new amino acid based formula. Subjects with CMA will take their randomised formula for 12 months. Following completion of the intervention (12 months), subjects will transfer to an age appropriate formula and be followed-up at 24 and 36 months.
~Infants should typically consume the following amounts of formula during the study > 500mls/day up to 12 months of age > 400mls/day between 12 and 18 months of age > 300mls/day over 18 months of age."
16236822|NCT01109953|Other|Breath-Hold PET/CT image set|In addition to the standard clinical PET/CT images, we will provide a breath-hold PET/CT image set, using the same PET data for both. In order to spatially match PET, and therefore improve attenuation correction in the PET images, we will acquire a Breath-Hold CT at 310 mA over the same region covered by PET. The normal-organ doses accumulated from the additional 30 mA CT. The patient's breathing signal during CT and the whole body PET will be recorded using a video camera and in house developed software. We will compare the clinical PET/CT and Breath-Hold PET/CT in regards to lesion detection, lesion volume, and SUV quantification.
16236823|NCT01109940|Biological|AIN457A|
16236824|NCT01109927|Drug|Insulin|Insulin treatment in accordance to glucose values
16236825|NCT01109914|Biological|Dukoral|"Two oral doses of Dukoral® (SBL Vaccines) will be administered (day 0 and day 14). Each dosage contains 3 ml of suspension in a vial and 5.6 g of effervescent granules in a sachet. Each dosage (3 ml) contains: A total of 100000 million bacteria of the following strains:
~Vibrio cholerae O1 Inaba, classical biotype (heat inactivated) 25x1000 million bacteria*
~Vibrio cholerae O1 Inaba, El Tor biotype (formalin inactivated) 25x1000 million bacteria*
~Vibrio cholerae O1 Ogawa, classical biotype (heat inactivated) 25x1000 million bacteria*
~Vibrio cholerae O1 Ogawa, classical biotype (formalin inactivated) 25x1000 million bacteria*
~Recombinant cholera toxin B subunit (rCTB) 1 mg (produced in V. cholerae O1 Inaba, classical biotype strain 213)"
16236826|NCT01109901|Procedure|anterior subcutaneous transposition|transposition of ulnar nerve into subcutaneous bed
16236827|NCT01109901|Procedure|Anterior submuscular transposition|transposition of ulnar nerve into muscular tissue
16236828|NCT01109888|Drug|Cetrotide|
16236829|NCT01109875|Other|blood test|Dry blood spots (DBS) analysis of a- galactosidase-A activity will be used for male patients' diagnosis. Males and females with enzymatic activity bellow the test's cut-off will be further diagnosed by gene sequencing. Since females are heterozygote and may have high residual levels of active enzyme, female patients with a- galactosidase-A activity of 30% bellow averaged normal range will also be further diagnosed by gene sequencing as described before (8).
16236830|NCT01109862|Procedure|Total hip arthroplasty|All cemented THA
16236831|NCT01109862|Procedure|Hemiarthroplasty|Cemented bipolar HAP
16236832|NCT01109849|Behavioral|behavior therapy|combination of individual and group parent training plus school consultation
16236833|NCT01109849|Drug|Extended release (ER) methylphenidate product|medication to be taken daily for duration of study unless assigned to weight promotion arm
16236834|NCT01109849|Other|monitoring|monthly weight, height and BMI checks
16236835|NCT01109849|Other|drug holiday|switch from seven day a week dosing to medication only on school days
16236836|NCT01109849|Dietary Supplement|caloric supplement|continue current ADHD regimen and add one 8oz liquid caloric supplement at night
16236837|NCT01109836|Behavioral|Motivation and lifestyle intervention|Intensive control and motivation for better compliance with medication, regular blood pressure measurements, diet changes and physical activity.
16236838|NCT01109823|Drug|intravenous administration of levofloxacin|Intravenous administration of levofloxacin is used.
16236839|NCT01109797|Behavioral|Transition Social Behavioral Intervention|"If you are assigned to the first group, you will have two all-day Saturday sessions four weeks apart on the KU campus in Lawrence. The objectives of the Saturday programs are to promote positive behavior change with respect to taking ownership of diabetes and its demands by providing transition-specific information, enabling participants to practice the life skills needed to successfully manage diabetes as an adult, and fostering peer-to-peer social networking over the 6-month period of the intervention (and beyond). You will continue to see your current provider of diabetes care outside of the parameters of this study."
16236911|NCT01109134|Drug|tirofiban intracoronary bolus-only|administer tirofiban bolus intracoronary during primary percutaneous coronary intervention with no additional maintenance infusion
16236840|NCT01109797|Behavioral|Diabetes Transition Clinic|Patients who participate in the transition clinic arm of the study will be seen six times during a six-month time period, as well as receive psychological assessment and intervention, as necessary, prior to the first clinic visit (intake) and as part of visits 2 and 4. Three of the six visits will be standard of care medical visits with either a pediatric or adult provider or both. Three will be individual or group education sessions with diabetes educators focused on transition issues such as, managing the adult health care system, talking with your care provider,and dealing with adult issues (pregnancy, genetic concerns, etc).
16236841|NCT01109784|Drug|prasugrel|prasugrel 10 mg/day
16236842|NCT01109784|Drug|clopidogrel|clopidogrel per os 150mg/day
16236843|NCT01109771|Device|permanent mesh fixation|Permanent mesh fixation will be used.
16236844|NCT01109771|Device|absorbable mesh fixation|Absorbable mesh fixation will be used.
16236845|NCT01109758|Drug|Fenofibrate|145 mg
16236846|NCT01109745|Other|PELICAN Primary Care|The intervention is the integration of the output of the Pelican instrument in daily care to guide disease management for children with asthma treated in primary care. The general practitioner can integrate the information of the Pelican instrument in their consultation and disease management decisions. The general practitioner will be trained and supported to negotiate the child's, and physicians' agendas based on the outcome of the instrument, and discuss possible interventions. All participating children of a GP will be allocated to the same treatment group (i.e., hierarchical or nested design).
16236847|NCT01109745|Other|PELICAN Secondary Care|The intervention is the integration of the output of the Pelican instrument in daily care to guide disease management for children with asthma treated in secondary care. The nurse can integrate the information of the Pelican instrument in their consultation and disease management decisions. The paediatricians will be trained and supported to negotiate the child's, and nurses' agendas based on the outcome of the instrument, and discuss possible interventions.
16236848|NCT01109732|Other|Systematic physical training with instructor|Training 3 times per week for 6 months, the first 3 months with an instructor
16236849|NCT01109706|Other|biological parameters dosage|"200 patients will be enrolled in the study (n=100 patients under statin treatment, n=100 patients without statin).
~After checking inclusion and non-inclusion criteria and obtaining informed consent from the patients. The SYNTAX score will be calculated and will allow to determine coronary analysis will be done at J1 and J4 (glucose, HbA1C, lipids, ApoA1, ApoB, sterols, plasmatic bile acids, insulinemia, creatinin clearance, hepatic function panel, CRPus and PCSK9 level assessment).
~Then, a sub-group of 30 patients will have supplementary blood analysis at 1 and 6 months after their admission, during their usual follow-up."
16236850|NCT01109693|Drug|Sertraline|Sertraline 50 mg/d or 100 mg/d for 6 more weeks
16236851|NCT01109693|Drug|Mirtazapine|Augment with or switch to mirtazapine 15-45 mg/d
16236852|NCT01109680|Drug|Neramexane|Multiple dose Neramexane followed by single dose 14C Neramexane
16236853|NCT01109654|Drug|Cetrorelix acetate and Follitropin alfa|Cetrorelix acetate given either as a single-dose regimen of 3 mg injection or as a multiple-dose regimen of 0.25 mg daily injection.Ovarian stimulation therapy with Follitropin alfa generally starts on cycle Day 2 or 3. The starting dose of Follitropin alfa is based on the Investigators' discretion
16236854|NCT01109641|Device|diagnostic electrophysiology catheter|electrical measurements through a diagnostic electrophysiology catheter
16236855|NCT01109628|Dietary Supplement|Protein drink|Twice a day during 6 months
16236856|NCT01109628|Dietary Supplement|Placebo drink|Twice a day during 6 months
16236857|NCT01109615|Drug|Pemetrexed|400 mg/m2 on day 1 of a 3 weeks cycle
16236858|NCT01109615|Drug|Gemcitabine|1000 mg/m2 intravenously on day 1 and 8 of a 3 weeks cycle
16236859|NCT01109602|Other|Yoga focused on strength, flexibility, and balance|Participants completed 8 weeks of yoga therapy. The yoga was focused on strength, flexibility, and balance therapy after stroke to impact fear of falling, balance, mobility, QoL, and blood pressure after stroke. The in-person yoga intervention included seated, standing, and floor poses. All study participants were able to complete transfers to the floor or mat table and complete all postures and breathing exercises.
16236860|NCT01109576|Behavioral|DSL Workshop|A series of 6 weekly 2 hour interactive workshops for Veterans with age-related Dual Sensory Loss that provide instruction, skills training, exercises and facilitated interaction among peers.
16236861|NCT01109563|Behavioral|Marijuana Check-Ins|The MCI, an MET intervention, will include the provision of personalized feedback with a motivational interviewing style. The focus of these sessions will be individualized to participants based on recent marijuana use and related experiences. Feedback given to participants during the MCI session will review progress toward goals as self-reported in percent days abstinent, normative data regarding marijuana use, review of reported consequences of marijuana use, review of abuse and dependence criteria reported, comparison of consequences and abuse and dependence symptoms reported over time, review of the positive outcomes from reductions in use, and review of immediate and long-term life goals and how their marijuana goal will affect these. HEs will offer particular encouragement to take advantage of CBT sessions to participants who feel they currently need treatment.
16236862|NCT01109550|Procedure|ERCP|endoscopic retrograde cholangiopancreatography transpapillary biopsies
16236863|NCT01109524|Drug|Cetuximab|Vial, Intravenous, 400mg/m², week 1, then 250mg/m², Weekly, Until Progressive Disease (PD)/ Toxicity/Pt-PI Decision
16236864|NCT01109524|Drug|Cisplatin|Vial, Intravenous, 80mg/m², Day 1 of each 21 day cycle, Maximum 6 cycles
16236865|NCT01109524|Drug|Vinorelbine|Vial, Intravenous, 25 mg/m², Day 1 and 8 of each 21 day cycle, Maximum 6 cycles
16236866|NCT01109511|Drug|naloxone|
16236867|NCT01109511|Drug|oxycodone|
16236868|NCT01109498|Genetic|Alipogene Tiparvovec (AMT-011), Human LPL [S447X]|intra muscular, 1 x E12 gc per kg body weight, injected in a single series of intramuscular injections
16236869|NCT01109498|Drug|Mycophenolate mofetil|oral, 2 g/day, day -3 till week 12
16236870|NCT01109498|Genetic|Alipogene Tiparvovec (AMT-011), Human LPL [S447X]|intra muscular, 3 x E11 gc per kg body weight, injected in a single series of intramuscular injections
16236871|NCT01109498|Drug|cyclosporine|oral, 3 mg/kg/day, day -3 till week 12
16236872|NCT01109485|Drug|Olopatadine hydrochloride ophthalmic solution 0.1%|1-2 drops 4 times per day
16236873|NCT01109472|Other|patient magazine|patient magazine individually tailored to patient's prior feedback
16236874|NCT01109459|Other|Pediatric blood pressure screening|Website presenting case-based education with tailoring based on knowledge and interactive with responses collected on line. Has a tool box for office materials to promote and encourage guideline based performance.
16236875|NCT01109459|Other|Pediatric vision screening|Website presenting case-based education about amblyopia and strabismus with tailoring based on knowledge and interactive with responses collected on line. Has a tool box for office materials to promote and encourage guideline based performance.
16236876|NCT01109446|Biological|Platelet Rich Plasma|27ml of autologous whole blood added to 3ml of ACD-A (Citrate Anticoagulant). After separation of the platelets, a high concentration of platelets (3-4ml Platelet Rich Plasma) is injected into the tendon through 7 perforations of the tendon, guided by ultrasound.
16236877|NCT01109446|Procedure|Isotonic Saline Solutions|3ml of Isotonic Saline Solution is injected into the tendon through 7 perforations of the tendon, guided by ultrasound.
16236878|NCT01109446|Drug|Triamcinolonacetonid|Triamcinolonacetonid 40mg/ml. 40mg of Triamcinolonacetonid is mixed with 2ml of Lidocaine 10mg/ml. It is injected deep into the tendon, guided by ultrasound.
16236879|NCT01109381|Drug|GT08|GT08 is the combination of omeprazole 40mg daily, lauric acid 150-300mg daily, NAC 1.2 - 2g daily
16236880|NCT01109355|Other|lung mechanics ventilatory|To perform the evaluation of lung mechanics ventilatory mode was changed to control volume with the following parameters: tidal volume (Vt) = 8ml/kg weight, peak flow (PF) = 6 x minute volume, fraction of inspired O2 (FiO2) = 40%, respiratory rate (RR) = 16 bpm, sensitivity = 1 cmH2O. The following variables were monitored: PIC, Blood Pressure (BP), heart rate (HR), peak pressure in the airways (pp.) and plateau pressure of the respiratory system (Ppl.), these values were monitored with PEEP = 5 cmH2O. PEEP employed ranged from 0 to 14 cmH2O. To eliminate a possible physiological accommodation by the progressive increase of PEEP, the range of values was determined by drawing a sealed envelope for each patient, ranging from 2 to 2 cmH2O.
16236881|NCT01109355|Other|Hemodynamic and intracranial pressure|At each value of PEEP the patient was ventilated for a period of five minutes to carry out monitoring of ICP, BP, HR, PPC and peripheral oxygen saturation (SpO2). The ICP monitoring catheter was kept closed for drainage and open for monitoring, since the arrival of the surgical block, was only open for drainage if there was an increase in ICP above 20 mmHg.
16236882|NCT01109329|Biological|HMPV challenge virus|Single dose of 10^6 plaque forming units (PFU) of recombinant HMPV small hydrophobic genes (rHMPV-SHs)
16236883|NCT01109316|Drug|Insulin lispro 2 day reservoir in-use|Insulin lispro 2 Day (L2D) administered by infusion pump for 8 week treatment period.
16236884|NCT01109316|Drug|Insulin lispro 6 day reservoir in-use|Insulin lispro 6 Day (L6D) administered by infusion pump for 8 week treatment period.
16236885|NCT01109316|Drug|Insulin aspart 6 day reservoir in-use|Insulin aspart 6 Day (A6D) administered by infusion pump for 8 week treatment period.
16236886|NCT01109303|Procedure|TightRope System- Arthrex® / Dynamic Implant|Patients are operated on using a dynamic implant, the TightRope System by Arthrex®. The ankle is immobilized in a plaster boot for 6 weeks.
16236887|NCT01109303|Procedure|Screw fixation - Synthes® / Static Implant|Patients are operated on using a static implant, the rigid four-cortices 3,5 mm screw fixation by Synthes®. The ankle is immobilized in a plaster boot for 6 weeks.
16236888|NCT01109264|Drug|Bendamustine hydrochloride injection|d1-2, i.v.gtt, 100mg/m2, 28 days per cycle, at most 6 cycles
16236889|NCT01109264|Drug|Chlorambucil|d1-d2, d15-d16, p.o., 0.4mg/kg/day, 28 days per cycle, at most 6 cycles
16236890|NCT01109251|Procedure|Auto-measure of the tension by an autotensiometer|"All hypertended patients able to realise a serie of tensional auto-measures will be invited to realise a serie of tensional auto-measures theree days before the consultation in the neurology department.
~The auto-measures will be performed according the methodology recommended by HAS."
16236891|NCT01109251|Procedure|Auto-measure of the tension by an autotensiometer|"All hypertended patients able to realise a serie of tensional auto-measures will be invited to realise a serie of tensional auto-measures theree days before the consultation in the neurology department.
~The auto-measures will be performed according the methodology recommended by HAS."
16236892|NCT01109225|Biological|blood sample|
16236893|NCT01109225|Procedure|MRI|
16236894|NCT01109225|Procedure|echocardiography|
16236895|NCT01109225|Biological|urine sample|
16236896|NCT01109225|Procedure|pulmonary echography|
16236897|NCT01109225|Procedure|vascular check|
16236898|NCT01109225|Procedure|renal echography|
16236899|NCT01109212|Drug|Bindarit|dosage form:tablet dosage:2x300 mg frequency:b.i.d duration:12 weeks
16236900|NCT01109212|Drug|Placebo|dosage form: tablet dosage: n.a. frequency: 2xplacebo b.i.d duration:12 weeks
16236901|NCT01109199|Dietary Supplement|PolyGlycopleX (PGX)|The full dose of the study intervention is 15 grams per day and total number of calories with the LCD is 1000 kcal/day.
16236902|NCT01109199|Dietary Supplement|Rice flour|The full dose of the placebo comparator is 15 grams per day and total number of calories with the LCD is 1000 kcal/day.
16236903|NCT01109186|Other|biological parameters|blood sample at M1, M2, M3; M4; M5, M6, M7, M8 and M9 after kidney transplantation
16236904|NCT01109173|Drug|Nepafenac Ophthalmic Suspension, 0.3%|Nepafenac Ophthalmic Suspension, 0.3%, one drop in affected eye once daily, for 16 days. An additional dose was administered between 30-120 minutes prior to surgery.
16236905|NCT01109173|Drug|Nepafenac Ophthalmic Suspension, 0.1%|Nepafenac Ophthalmic Suspension, 0.1%, one drop in affected eye three times daily, for 16 days
16236906|NCT01109173|Other|Nepafenac Ophthalmic Suspension 0.3% Vehicle|Nepafenac 0.3% vehicle, one drop in affected eye once daily, for 16 days. An additional dose was administered between 30-120 minutes prior to surgery.
16236907|NCT01109173|Other|NEVANAC Vehicle|Nepafenac vehicle, one drop in affected eye three times daily, for 16 days
16236908|NCT01109160|Drug|Azithromycin Dihydrate|"Add-on of study-drug (azithromycin) to 'standard of care' at diagnosis of lymphocytic bronchi(oli)tis.
~Study-drug regime: 250 mg daily for 5 days, followed by 250 mg every other day until the end of the study-period (6 months treatment)."
16236909|NCT01109147|Other|Imagery|All the subject will be submitted to an functional magnetic resonance imaging (fMRI) examination.
16236910|NCT01109147|Genetic|pharmacogenetic sampling|A pharmacogenetic sample will be done with an additional consentment.
16236950|NCT01108744|Drug|Mannitol|Mannitol 20% intravenous solution, dosed by patient's ideal body weight
16236912|NCT01109134|Drug|tirofiban intravenous bolus plus infusion|administer tirofiban bolus intravenously and maintain infusion for up to 18 hours
16236913|NCT01109121|Drug|Combination 400|Tranilast 300 mg QD; Allopurinol 400 mg QD
16236914|NCT01109121|Drug|Allopurinol|Allopurinol 400 mg, QD
16236915|NCT01109121|Drug|Combination 600|Tranilast, 300 mg QD; Allopurinol 600 mg QD
16236916|NCT01109095|Biological|HER.CAR CMV-specific CTLs|"HER2.CAR CMV-specific CTLs will be given by intravenous injection over 1-10 minutes through either a peripheral or a central line with a minimum 20g cannula. The patient will get one of the following doses:
~1 x 10^6/m^2
~3 x 10^6/m^2
~1 x 10^7/m^2
~3 x 10^7/m^2
~1 x 10^8/m^2"
16236917|NCT01109082|Procedure|posterior spine fusion|vertebrae are fused to straighten a spinal curve
16236918|NCT01109069|Drug|PCI-32765|Dose based on parent protocol
16236919|NCT01109056|Drug|cyclosporine ophthalmic emulsion 0.05%|One drop in the study eye (or eyes) administered four times daily (QID)
16236920|NCT01109056|Drug|Vehicle|One drop in the study eye (or eyes) administered four times daily (QID)
16236921|NCT01109043|Drug|Bisoprolol or bisoprolol + HCTZ|Film-coated tablets containing 5 mg or 10 mg of bisoprolol hemifumarate or film-coated tablets containing 5 mg of bisoprolol fumarate (2:1) and 12.5 mg of HCTZ were given
16236922|NCT01109030|Drug|Pioglitazone+Citalopram+Chlordiazepoxide|"Pioglitazone 15 mg every 12 hours for six weeks Citalopram 20 mg per day for week one, and then 30 mg/day for 5 consecutive weeks.
~Chlordiazepoxide 10 mg each night for first three weeks"
16236923|NCT01109030|Drug|Placebo+ Citalopram+ Chlordiazepoxide|"Placebo 1 Q12h for 6 weeks with the same shape and color as Pioglitazone. Citalopram 20 mg per day for week one, and then 30 mg/day for 5 consecutive weeks.
~Chlordiazepoxide 10 mg each night for first three weeks"
16236924|NCT01109017|Drug|somatropin|Norditropin® (somatropin) prescribed at the discretion of the physician according to normal clinical practice. Safety and effectiveness data is recorded by the physician, and a Quality of Life form is completed by the patient, at visits 1 to 5.
16236925|NCT01109004|Drug|Lenalidomide|All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive a second autologous PBSC transplant with the same conditioning regimen as the first transplant. All patients will also receive maintenance lenalidomide which will start after the second transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
16236926|NCT01109004|Drug|lenalidomide, bortezomib and dexamethasone|All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive consolidation therapy with RVD (lenalidomide 15 mg/day on Days 1-14, dexamethasone 40mg on Days 1, 8 and 15, and bortezomib 1.3mg/m2 on Days 1, 4, 8 and 11 of every 21 day cycle, patients will receive four cycles). All patients will also receive maintenance lenalidomide which will start after consolidation therapy. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
16236927|NCT01109004|Drug|Lenalidomide|All patients will undergo a first autologous peripheral blood stem cell (PBSC) transplant with high-dose melphalan (200 mg/m^2 IV) given on Day -2. Upon recovery from the first transplant patients will receive maintenance with lenalidomide (15 mg daily). Maintenance lenalidomide will start after the first autologous transplant. Maintenance therapy with lenalidomide will start at 10 mg daily for 3 months and increase to 15 mg daily. The duration of maintenance will be three years in all treatment arms.
16236928|NCT01108991|Behavioral|Physical activity self-management|This intervention includes a manual, telephone health coach calls, and automated telephone calls. The manual has 20 chapters for the active phase and 5 maintenance phase chapters. During the first 20 weeks the health coach will call patients every other week and the automated telephone calls will occur on the alternate weeks.
16236929|NCT01108991|Other|COPD education + Usual care|Six weeks of COPD self-management education plus usual care
16236930|NCT01108978|Drug|Placebo|Dehypotin® 40 mg/day or placebo, once a day, shortly after baseline for 12 consecutive weeks
16236931|NCT01108978|Drug|Dehypotin|Dehypotin® 40 mg/day or placebo, once a day, shortly after baseline for 12 consecutive weeks
16236932|NCT01108939|Drug|Antimalarial treatment|
16236933|NCT01108939|Other|Observation|
16236934|NCT01108926|Drug|Atripla®|All subjects will be administered Atripla® (tenofovir 245 mg plus emtricitabine 200 mg plus efavirenz 600 mg), one tablet orally once daily for 14 days
16236935|NCT01108913|Drug|Bimosiamose|
16236936|NCT01108913|Drug|Placebo|
16236937|NCT01108900|Drug|sildenafil|tables, 25,50,100 mg, on demand, 1 month
16236938|NCT01108874|Drug|Metaraminol|Patients will be given metaraminol every time SBP falls below baseline value.
16236939|NCT01108861|Device|GORE VIABAHN® Endoprosthesis|GORE VIABAHN® Endoprosthesis
16236940|NCT01108861|Device|Plain old balloon angioplasty|Plain old balloon angioplasty
16236941|NCT01108848|Biological|Berinert® (C1 Esterase Inhibitor)|Berinert® is marketed as a lyophilized concentrate available in a single-use vial to be reconstituted with sterile water before administration as described in the prescribing information.
16236942|NCT01108835|Other|Comprehensive care programme|"Intervention group:
~Patients will be interviewed by a respiratory nurse and given education in 1-2 sessions
~Physiotherapist assessment and training (individualized physical training programme to perform at home or a short course out-patient pulmonary rehabilitation)
~Respiratory physician assessment and optimization of treatment
~Patients will also be taught about a personalized action plan by the physician and respiratory nurse.
~Subsequent intervention: Patients will receive monthly telephone calls by a respiratory nurse for a period of 1 year to assess their conditions and also answer their queries."
16236943|NCT01108809|Drug|Telmisartan or Telmisartan and Hydrochlorthiazide|Telmisartan 80mg +/- Hydrochlorthiazide 12.5mg or 25mg
16236944|NCT01108783|Drug|Bilastine|20 mg (encapsulated) tablets QD/14 days
16236945|NCT01108783|Drug|Desloratadine|5 mg (encapsulated) tablets QD/14 days
16236946|NCT01108783|Drug|Placebo|(encapsulated) Tablets QD/14 days
16236947|NCT01108757|Drug|Bactrim|Bactrim DS BID for 3 days
16236948|NCT01108757|Other|Placebo|Corn starch capsules
16236949|NCT01108744|Drug|hypertonic saline|3% hypertonic saline, dosed by ideal patient weight
16236951|NCT01108731|Drug|Milnacipran|"Patients will take an increasing number of 12.5mg pills for the first 9 days during the ramp up period and then take one 50mg pill in the morning and one 50mg pill in the evening for the remaining 8 weeks of the study."
16236952|NCT01108731|Drug|Placebo|"Patients will take an increasing number of placebo pills for the first 9 days during the ramp up period and then take one pill in the morning and one in the evening for the remaining 8 weeks of the study."
16236953|NCT01108718|Other|Tempur-Pedic Mattress (2 months)|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the Tempur-Pedic mattress first, then the Control Mattress.
16236954|NCT01108718|Other|Control Mattress (2 months)|Female subjects, aged 18 years or older who have been diagnosed with fibromyalgia and do not possess any sleep disorder receiving the control mattress first, then the Tempur-pedic Mattress.
16236955|NCT01108705|Drug|Brivanib|Tablets, Oral, 800 mg, once daily, until disease progression or toxicity
16236956|NCT01108705|Drug|Placebo|Tablets, Oral, 0mg, once daily, until disease progression or toxicity
16236957|NCT01108692|Other|Telecardiology|"Telecardiology will be switched on for both groups. For the Active group, all data will be transmitted to the physician. For the Control group, data will not be used for patients surveillance, only events regarding implant (Elective Replacement Indication) or events regarding data transmission missing will be generated and sent to the physician.
~A retrospective analysis will be performed at the end of the study to compare the results in the two groups."
16236958|NCT01108666|Drug|Nelfinavir|Two dose levels of Nelfinavir will be evaluated in each concurrent chemotherapy group (carboplatin/paclitaxel and cisplatin/etoposide) at the RPTD does of proton beam radiotherapy: 625 and 1250 mg PO bid.
16236959|NCT01108653|Other|Usual care sick-leave management|Patients randomized to usual care. Follow up after discharge by general practitioner (GP) according to local practice.
16236960|NCT01108653|Other|Structuralised sick-leave program|Patients randomized to the structuralized program will get full time sick-leave for 2 weeks after discharge.Cardiologist will be responsible for individual adaption of each patient's sick-leave and follow-up.
16236961|NCT01108627|Drug|open-labeled inhaled corticosteroids (ICS); FORADIL® AEROLIZER®|• Drugs. The study drugs are open-labeled inhaled corticosteroids (ICS); FORADIL® AEROLIZER® and FORADIL placebo. FORADIL® AEROLIZER® consists of a capsule dosage form containing a dry powder formulation of FORADIL (formoterol fumarate) intended for oral inhalation only with the AEROLIZER Inhaler. Each clear, hard gelatin capsule contains a dry powder blend of 12 mcg of formoterol fumarate and 25 mg of lactose (which contains trace levels of milk proteins) as a carrier. Ten capsules are contained in each package, which is clearly labeled. To use the delivery system, a FORADIL capsule is placed in the well of the AEROLIZER Inhaler, and the capsule is pierced by pressing and releasing the buttons on the side of the device. The formoterol fumarate formulation is dispersed into the air stream when the patient inhales rapidly and deeply through the mouthpiece.
16236962|NCT01108627|Drug|foradil placebo|open-labeled inhaled corticosteroids (ICS); foradil placebo
16236963|NCT01108627|Drug|foradil|open-labeled inhaled corticosteroids (ICS); foradil
16236964|NCT01108614|Behavioral|Intervention|Intensive HIV psychological counseling ,Increased methadone dosage under individualized treatment principle, enhance randomized urine test, strengthen family and social support , partner notification and routine HIV testing, condom promotion, STD referral services.
16236965|NCT01108601|Drug|Ringer's Lactate (0.03% Ciprofloxacin)|For each patient, only one ear will receive the Ringer's Lactate solution. The other ear will act as a control. To ensure adequate delivery of the solution to the middle ear, a small pressure equalizing tube will be inserted under local anesthesia before commencement of chemotherapy treatment. The patient will be instructed to administer four drops of RL solution to the experimental ear twice a day during their chemotherapy treatment.
16236966|NCT01108588|Drug|Placebo (to match Aspirin)|Placebo grossly matched Aspirin 300 mg daily
16236967|NCT01108588|Drug|Aspirin|Aspirin 300 mg daily
16236968|NCT01108588|Drug|Clopidogrel|Clopidogrel 75 mg daily
16236969|NCT01108588|Drug|Comparator: Placebo (to match Clopidogrel)|Placebo (grossly matched Clopidogrel 75 mg) daily
16236970|NCT01108575|Other|IMST|inspiratory muscle strength training
16236971|NCT01108575|Other|Sham IMST|sham inspiratory muscle strength training
16236972|NCT01108562|Drug|Lidocaine|Patients in the experimental group will be receiving a Lidocaine infusion at 1.33 mg/kg/hr for 24 hours postoperatively.
16236973|NCT01108562|Other|Normal Saline|Patients in the control group will be receiving an infusion of normal saline for 24 hours postoperatively.
16236974|NCT01108549|Dietary Supplement|Ribose|Ribose 5 grams PO TID was taken daily
16236975|NCT01108536|Device|adaptive prosthetic socket|trans tibial socket with actuator zones (inflatable fluid bladders)
16236976|NCT01108523|Device|HP828-101|
16236977|NCT01108510|Drug|COBI|Cobicistat (COBI) 150 mg tablet administered orally once daily
16236978|NCT01108510|Drug|RTV|Ritonavir (RTV) 100 mg tablet administered orally once daily
16236979|NCT01108510|Drug|ATV|Atazanavir (ATV) 300 mg capsule administered orally once daily
16236980|NCT01108510|Drug|FTC/TDF|Emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg fixed-dose combination tablet administered orally once daily
16236981|NCT01108510|Drug|COBI placebo|Placebo to match COBI administered orally once daily
16236982|NCT01108510|Drug|RTV placebo|Placebo to match RTV administered orally once daily
16236983|NCT01108497|Procedure|Bone Marrow Aspiration|
16236984|NCT01108484|Behavioral|Exercise|Supervised exercise: Three 90-minutes sessions per week.
16236985|NCT01108484|Behavioral|Exercise + Diet counseling|Supervised exercise: Three 90-minutes sessions per week. Diet counseling: Counseling to balance the intake.
16236986|NCT01108484|Behavioral|Exercise + Diet counseling + psycho-emotional support|Supervised exercise: Three 90-minutes sessions per week. Diet counseling: Counseling to balance the intake. Psycho-emotional support: Weekly sessions to modify the behaviour.
16236987|NCT01108458|Drug|Pertuzumab|iv, 840 mg, 420 mg
16236988|NCT01108458|Drug|Erlotinib|PO, 150 mg
16236989|NCT01108445|Drug|Everolimus|Subjects in this treatment arm will receive everolimusRAD001 10 mg orally once daily by mouth on days 1 through 42 for each 42 day cycle.
16236990|NCT01108445|Drug|Sunitinib|50 mg daily by mouth on days 1 through 28 of each 42 day cycle.
16236991|NCT01108432|Other|Electronic Referral|Dental practices in this arm will be able to have option of making electronic patient referrals to the Decide2Quit website.
16236992|NCT01108419|Other|Fermented dairy product|
16236993|NCT01108419|Other|milk-based non-fermented dairy product|
16236994|NCT01108406|Device|Sonitus SoundBite System|Non Surgical Bone Conduction Device
16236995|NCT01108406|Device|SoundBite Hearing System|
16236996|NCT01108393|Drug|Agomelatine A|"Agomelatine 25 mg film-coated tablet
~Agomelatine 2x25mg film-coated tablet"
16236997|NCT01108393|Drug|Placebo|Placebo
16236998|NCT01108380|Procedure|Plasma pheresis, Right portal vein embolization|"Plasma pheresis : With insertin of 2 intravenous line, plasmapheresis will be done with COBE BCT Inc. It will be performed under supervision of clinical laboratorians and doctors.
~Right portal vein : Under ultrasonography guided, left portal vein be punctured. Right portal vein will be embolized by coil or gelfoam."
16236999|NCT01108341|Drug|Bendamustine hydrochloride|Bendamustine will be administered at 90 mg/m^2 as a 30-minute intravenous (iv) infusion on days 1 and 2 of each cycle.
16237000|NCT01108341|Drug|Ofatumumab|Ofatumumab will be administered at 300 mg as an iv infusion on day 1 and 1000 mg on day 8 of cycle 1 and 1000 mg on day 1 of each subsequent cycle.
16237001|NCT01108328|Dietary Supplement|PolyGlycopleX (PGX)|powder, 5 grams, 3 times per day at each main meal (breakfast, lunch and dinner) for a total of 3 days
16237002|NCT01108315|Other|Report symptoms via web or phone-based system|The participant reports their symptoms at least twice a week via the phone or web-based prototype system.
16237003|NCT01108302|Other|Oxytocin in Uniject|10 IU Oxytocin delivered intramuscularly immediately after delivery of the baby
16237004|NCT01108289|Other|Oxytocin in Uniject|10 IU Oxytocin delivered intramuscularly immediately after delivery of the baby
16237005|NCT01108276|Device|Convatec engenex negative pressure wound therapy|ConvaTec Engenex® is a negative pressure wound therapy that stimulates wound healing and promotes granulation tissue formation, removal of wound exudate and infectious materials by the application of negative pressure to wounds. It utilizes Bio-Dome™ Dressing technology to effectively control infection, drainage and odor while promoting granulation and wound healing at 75mmHg pressure.
16237006|NCT01108263|Drug|INTEGRA™ Flowable Matrix (Collagen)|INTEGRA™ Flowable Wound Matrix is an advanced 3-D porous matrix comprised of granulated cross-linked bovine tendon collagen and glycosaminoglycan. It provides a scaffold for cellular invasion and capillary growth. The collagen and glycosaminoglycan mix is hydrated with saline and applied on the wound bed.
16237007|NCT01108250|Genetic|LOC387715/HTRA1 genotyping|Genomic DNA was extracted from whole blood by standard methods. Genotyping was performed using SNP Genotyping Assays.
16237008|NCT01108237|Other|TruMatch™ Personalized Solutions|TruMatch™ Personalized Solutions is the brand name of DePuy Orthopaedics, Inc. custom patient instrumentation. TruMatch™ is a pair of custom-made cutting blocks that allow distal femoral and proximal tibial cuts to be made according to a predefined surgical plan. The inner surface of the femoral block is manufactured to match the geometry of the patient's distal femur. The inner surface of the tibial block is manufactured to match the patient's proximal tibia. The geometric data is obtained from a CT scan and a preoperative plan approved by the surgeon.
16237009|NCT01108237|Device|Total Knee Arthroplasty with Conventional Instrumentation.|Total Knee Arthroplasty (PFC Sigma System) implanted using conventional instruments, not TruMatch™ instrumentation.
16237010|NCT01108224|Behavioral|Psychosocial support|Psycho-social group intervention including patient-education for 6 h per week for 2 weeks and group therapy 2½ h for 8 weeks
16237011|NCT01108211|Device|Vibration Platform|The patients receive treatment by standing on the Vibration Platform 20 minutes a day, five days a week. The platform will deliver a vibration of 0.3g with a vertical displacement of 0.085mm at 35 Hz.
16237012|NCT01108198|Drug|Mometasone furoate cream|Study cream was applicated once per day for 4-8 weeks.
16237013|NCT01108198|Drug|moisturizing cream|study cream was applicated once per day for 4 to 8 weeks
16237014|NCT01108172|Other|Virtual Ward|A multidisciplinary team to optimize medical and social care for patients residing in their own homes
16237015|NCT01108172|Other|Usual care|The usual care provided to patients after discharge from hospital
16237016|NCT01108159|Procedure|Blood Draw|
16237017|NCT01108159|Procedure|Skin Biopsy|
16237018|NCT01108146|Drug|Arm 1 Hydrocortisone 10 mg|"Group 1: Administration of Hydrocortisone and/or Placebo in the following order:
~1 week placebo- 1 week 10 mg hydrocortisone - 1 week placebo - 1 week 30 mg hydrocortisone"
16237019|NCT01108146|Drug|Arm 2 Hydrocortisone 30 mg|"Drug: Hydrocortisone 30 mg
~Group 2: Administration of Hydrocortisone and/or Placebo in the following order:
~1 week hydrocortisone 30 mg/d- 1 week placebo - 1 week hydrocortisone 10 mg/d - 1 week placebo"
16237020|NCT01108133|Drug|10 mg HydrocortisoneHöchst|10 mg Hydrocortisone Höchst are administered one hour before fMRI scanning
16237021|NCT01108133|Drug|Dexamethasone|2 mg Dexamethasone are administered at 10 pm the day before the fMRI experiment.
16237022|NCT01108133|Drug|Placebo|Placebo
16237023|NCT01108120|Drug|continuous intra-femoral thrombolysis group|Firstly, 20 0000 u urokinase is injected to the diseased foot via catheter. Then, continuous injection of urokinase via femoral artery by a artery mini-pump (100 ml 0.9% sodium chloride + 100 0000 unit urokinase at a rate of 4 ml per hour) is taken for 7 - 9 days.
16237024|NCT01108120|Drug|Conventional therapy group|All patients receive an intravenous injection of prostaglandin E1 20 ug per day during hospitalization period.
16237025|NCT01108107|Drug|Oxaliplatin|130 mg/m2 intravenously on day 1 of a 3-weekly cycle
16237026|NCT01108107|Drug|Capecitabine|2000 mg/m2/day (tablets) on day 1 and 14 of a 3-weekly cycle
16237027|NCT01108107|Drug|Oxaliplatin|130 mg/m2 intravenously on day 1 of a 3-weekly cycle
16237028|NCT01108107|Drug|Capecitabine|2000 mg/m2/day (tablets) on day 1 and 14 of a 3-weekly cycle
16237029|NCT01108107|Biological|Panitumumab|9 mg/kg intravenously on day 1 of a 3-weekly cycle
16237030|NCT01108094|Drug|Itraconazole|"Cohort A: oral itraconazole 400 mg as 200 mg twice daily; for 1 month
~Cohort B: oral itraconazole 200 mg as 100 mg twice daily; for up to 3 months"
16237031|NCT01108081|Behavioral|Physical activity|Moderate-intensity physical activity
16237032|NCT01108081|Behavioral|Diet|Dietary weight loss
16237033|NCT01108081|Behavioral|Health education|Attention control intervention
16237034|NCT01108068|Drug|Lithium|lithium will be given for 6 months to patients with OPPG, starting at a low dose of 2.5 mg/kg daily, gradually increasing until a lithium blood level of 0.3-0.6 ng/dl is achieved.
16237035|NCT01108055|Drug|Pazopanib (GW786034)|Cycle of 28 days. Pazopanib: 800mg/day
16237036|NCT01108055|Drug|Paclitaxel|Cycle of 28 days Paclitaxel: 80mg/m2 days 1,8 and 15
16237037|NCT01108042|Drug|Taxotere, Cisplatin, 5-Fluorouracil (5-FU)|Phase 1: Intravenous infusion of 40 mg/m² Taxotere and 40 mg/m² Cisplatin followed by 24 h-infusion of 2000 mg/m² 5-FU on day 1 and day 8 every 3 weeks. If possible an escalation to 50 mg/m² Taxotere and 50 mg/m² Cisplatin can be carried out. Phase 2: Optimal dose of phase 1 will be given.
16237038|NCT01108029|Drug|memantine|2 tablets of 10 mg of memantine 1 time a day in the morning
16237039|NCT01108029|Drug|placebo|2 tablets of placebo 1 time a day in the morning
16237040|NCT01108016|Behavioral|Videoconferencing support group|
16237041|NCT01108003|Drug|broccoli sprout extract|Given orally
16237042|NCT01108003|Other|laboratory biomarker analysis|Correlative studies
16237043|NCT01108003|Other|Mango Juice|given orally
16237044|NCT01107977|Behavioral|Iyengar yoga|Iyengar yoga twice/week for 6 weeks
16237045|NCT01107964|Drug|Oral Omega-3-acid ethyl esters|1 gram capsule by mouth four times daily for 45 days
16237046|NCT01107964|Drug|Placebo corn oil capsule|1 gram by mouth 4 times daily for 45 days
16237047|NCT01107951|Drug|Rituximab and dexamethasone|"Rituximab 100mg IV days 1,8,15,22.
~Dexamethasone 40mg PO days 1-4 (four days)"
16237048|NCT01107938|Drug|10 mg ilaprazole|Two 5-mg ilaprazole tablets (Livzon Pharm Group Inc., China) together with one placebo tablet of ilaprazole and one placebo tablet of esomeprazole in a package being taken orally each morning on an empty stomach for 8 weeks
16237049|NCT01107938|Drug|15 mg ilaprazole|Three 5-mg ilaprazole tablets (Livzon Pharm Group Inc., China) together with one placebo tablet of esomeprazole in a package being taken orally each morning on an empty stomach for 8 weeks
16237050|NCT01107938|Drug|40 mg esomeprazole|One 40-mg esomeprazole tablet (AstraZeneca, Nexium) together with three 5-mg placebo tablets of ilaprazole in a package being taken orally each morning on an empty stomach for 8 weeks
16237051|NCT01107925|Drug|prasugrel|Administered orally, daily for 12 days
16237052|NCT01107925|Drug|clopidogrel|Administered orally, daily for 12 days
16237053|NCT01107912|Drug|prasugrel|administered orally, daily for 12 days
16237054|NCT01107912|Drug|clopidogrel|Administered orally, daily for 12 days
16237055|NCT01107899|Drug|clopidogrel|taken orally, day one, single dose
16237056|NCT01107899|Drug|prasugrel|taken orally, day one, single dose
16237057|NCT01107886|Drug|Saxagliptin|5 mg or 2.5 mg once daily
16237058|NCT01107886|Drug|Placebo|
16237059|NCT01107860|Device|Computed Tomography|In Group I, fifty CBCT studies will be performed. The objectives will be to illustrate the capacity of CBCT to image the breast in its entirety as compared with the gold standard mammographic exam.
16237060|NCT01107860|Device|Computed Tomography|In Group II , at least three hundred and fifty (350) study participants, who require diagnostic evaluation of the breast will undergo a breast CBCT . These subjects may be referred for biopsy as a result of a finding from a mammogram, ultrasound, MRI, or clinical exam.
16237061|NCT01107847|Procedure|low flow pressure volume manoeuvre|In all patients a standard low flow pressure volume manoeuvre is applied by a respirator with a constant gas flow of 4 l/min starting at a zero end-expiratory pressure up to a tidal volume of 2 l or until a maximum airway pressure of 35 cm H2O was reached.
16237062|NCT01107821|Device|Engenex™ pump and Bio-Dome™ Wound Dressing|Engenex™ pump and Bio-Dome™ Wound Dressing is used.
16237063|NCT01107808|Drug|Calcium and Vit D|ergocalciferol (vitamin D2) treatment 50,000 IU orally, weekly for 8 weeks calcium carbonate orally 1200mg daily
16237064|NCT01107808|Drug|Metformin, Vit D and Calcium|ergocalciferol (vitamin D2)50,000 IU orally weekly for 8 weeks calcium carbonate orally 1200mg daily Metformin ER 1000mg daily with dinner for 7 days and then increased to a final dose of 2000mg orally, daily for the remainder of the study (7 weeks)
16237065|NCT01107795|Procedure|Transoral Robotic Surgery|Base of tongue resection with transoral robotic-assisted surgery (TORS).
16237066|NCT01107782|Drug|sildenafil|50 mg TDS orally until birth
16237067|NCT01107782|Drug|placebo|50mg tid
16237068|NCT01107756|Drug|LENOGRASTIM (GRANOGYTE 34)|Pharmaceutical form: solution Route of administration: intravenous Dose regimen:recommended dosing as per Granocyte 34 package insert
16237069|NCT01107743|Drug|Amlodipine/Atorvastatin|"Amlodipine and Atorvastatin combination Tablet is indicated in following subjects for whom treatment with both amlodipine and atorvastatin is appropriate.
~Subjects with concurrent hypertension or angina pectoris and hypercholesterolemia or familial hypercholesterolemia Indications for amlodipine and atorvastatin.
~For oral use, amlodipine and atorvastatin combination tablet is given once daily. Dosage must be individualized based on dosage and administration for each individual component.
~Amlodipine
~Hypertension Usual adult dosage is 2.5-5 mg of amlodipine given orally as a single daily dose.
~Angina pectoris For oral use, the usual adult dosage is 5 mg of amlodipine once daily. Atorvastatin
~Hypercholesterolemia For oral use, the usual adult dosage is 10-20 mg of atorvastatin once daily.
~Familial hypercholesterolemia For oral use, the usual adult dosage is 10-40 mg of atorvastatin once daily."
16237070|NCT01107730|Drug|Vitamin C|VitC intravenously (2g/day [500mgX4] for 2 days prior to surgery, and postoperatively for 4 days
16237071|NCT01107730|Drug|L-Carnitine|L-Carnitine intravenously (2 gr/day [1grX2] for 2 days prior to surgery, and postoperatively for 4 days
16237072|NCT01107730|Drug|Placebo|Placebo
16237073|NCT01107717|Drug|metformin\pioglitazone\exenatide|metformin (1000 mg), pioglitazone (15 mg) and exenatide (5 microgram bid) are started and dose is up titrated to achieve HbA1c < 6.5%
16237074|NCT01107717|Drug|metformin, glyburide and glargine|subjects are started on metformin 500 mg bid and dose is up titrated and glyburide (up to 5 mg) and glargine are sequentially added to maintain HbA1c < 6.5%
16237075|NCT01107704|Behavioral|Family Support Intervention|Multifaceted family support intervention
16237076|NCT01107691|Other|Amount of resistance offered in training|to determine the impact of the volume (1 vs. 3 sets) of a progressive resistance training protocol for inducing muscular hypertrophy
16237117|NCT01107418|Drug|RO5185426|dosage d) orally twice daily, days 1-15 (morning dose)
16237077|NCT01107678|Other|Healthy Snacks and Organized Physical Activity|Children in the intervention group will receive healthy snacks, smaller portion sizes and participate in organized physical activity on a daily bais
16237078|NCT01107665|Drug|Pazopanib and Paclitaxel|Paclitaxel will be administered intravenously at a starting dose of 80mg/m2 weekly for 3 weeks followed by a 1-week rest. Pazopanib will be administered orally, in a continuous regimen, with a starting dose of 800mg daily.
16237079|NCT01107639|Biological|cetuximab|Loading dose 400 mg/m2 2h infusion Weekly: 250 mg/m2 1h infusion
16237080|NCT01107639|Drug|cisplatin|"Cisplatin 75 mg/m2 1h infusion d1, 22
~Cisplatin 25 mg/m2 1h infusion weekly x5"
16237081|NCT01107639|Drug|docetaxel|"Docetaxel 75 mg/m2 1h infusion d1, 22
~Docetaxel 20 mg/m2 1/2h infusion weekly x5"
16237082|NCT01107639|Procedure|adjuvant therapy|During the adjuvant phase, all infusions, given every two weeks, will be at a dose of 500mg/m².
16237083|NCT01107639|Procedure|neoadjuvant therapy|During the neoadjuvant phase, the first infusion of cetuximab should be at a dose of 400 mg/m² administered over a period of 2 hours and all subsequent infusions, given weekly, should be of 250 mg/m² over a period of 1 hour, unless any infusion related reaction was observed at a previous infusion. (The maximum infusion rate is 10 mg/min, corresponding to 2 mL/min ready-to-use solution.
16237084|NCT01107626|Drug|Paclitaxel|Given IV
16237085|NCT01107626|Drug|Carboplatin|Given IV
16237086|NCT01107626|Biological|Bevacizumab|Given IV
16237087|NCT01107626|Drug|Pemetrexed Disodium Heptahydrate|Given IV
16237088|NCT01107613|Other|Opinion leader educational letter|All patients will receive prednisone X 10 days and antibiotics X 5 days, as well as an opinion leader letter sent to the primary care provider outlining the needs of this patient.
16237089|NCT01107600|Procedure|Immediate implant and socket preservation|Implant placed in fresh extraction sockets as part of the same surgical procedure, and placed into occlusal loading within 48 h of implant placement. Guided bone regeneration with Biomaterial to preserve bone loss after tooth extraction.
16237090|NCT01107587|Biological|GSK Biologicals' human rotavirus vaccine 444563|Oral, two doses.
16237091|NCT01107587|Biological|Placebo|Oral, two doses.
16237092|NCT01107574|Drug|Gabapentin|Gabapentin 900 mg po HS for 6 weeks treatment per patients enrolled in the Gabapentin Arm
16237093|NCT01107574|Procedure|Osteopathic Manipulative Medicine|Based on Osteopathic Structural Examination and Tender point Examination a 30 minute treatment of Osteopathic Manipulative Medicine was applied to each patient every week for 6 weeks.
16237094|NCT01107574|Other|Gabapentin and Osteopathic Manipulative Medicine|Combination therapy of gabapentin 900 mg po HS for 6 weeks and Osteopathic Manipulative Medicine 30 minute treatment weekly for each patient based on Osteopathic Structural Examination and Tender point Examination
16237095|NCT01107561|Other|Seldinger technique|Involves blind needle insertion through the skin into the cricoid membrane followed by insertion of the guide-wire and subsequent insertion of the tube over the guidewire
16237096|NCT01107561|Device|Surgical Airway Approach|The classical open or surgical technique involves a vertical skin incision with blunt dissection and identification of the anatomy followed by incision of the cricoid membrane and tube insertion.
16237097|NCT01107548|Other|Systematic detection of vascular risk factors and subsequent evidence-based treatment|
16237098|NCT01107535|Biological|Synagis (palivizumab), monoclonal antibody for passive immunoprophylaxis against severe RSV disease administered according to usual clinical practice.|Synagis (palivizumab) administered according to usual clinical practice. After the enrollment visit, subjects will have monthly visits until they have received the complete Synagis immunization regimen of their hospital, then they will have 2 follow up visits, one of them 30 days after the fifth dose of Synagis and the other visit at one year of age.
16237099|NCT01107522|Drug|CTO|Oral administration daily for 28 day cycles; starting dose of CTO = 50 mg/m2
16237100|NCT01107522|Drug|CTO and Temodar®|"Oral administration of CTO daily for 28 day cycles, starting dose of CTO = 219 mg/m2.
~Temodar® administered orally at fixed dose of 150 mg/m2 daily for Days 1-5 in a 28 day cycle.
~Expansion Cohort of 6 patients on fixed dose of 600mg CTO/day Temodar® administered orally at fixed dose of 150 mg/m2 daily for Days 1-5 in a 28 day cycle"
16237101|NCT01107522|Drug|CTO, Temodar®, Radiation therapy|Oral administration of CTO daily for 28 day cycles; starting dose of CTO = 219 mg/m2 Temodar® administered orally at a dose of 75 mg/m2 daily during radiation therapy, then at 150mg/m2 for Days 1-5 of Cycle 1, and then up to 200 mg/m2 Days 1-5 of subsequent cycles Radiation: 3-dimensional conformal radiation therapy or, Radiation: intensity-modulated radiation therapy
16237102|NCT01107509|Drug|everolimus|10 mg/ day everolimus in the form of an oral tablet for 12 weeks leading up to nephrectomy (with a 1-week perioperative washout period) in patients with locally advanced disease and re-initiating the drug postoperatively in patients with metastatic disease for up to 24 months, or until disease progression. Dosage may be reduced at any point to 5 mg/ day in the event of any grade 3/ 4 toxicity.
16237103|NCT01107496|Drug|SPN-812|Viloxazine, oral, 300mg, tid, 6 weeks
16237104|NCT01107496|Drug|Placebo|Placebo, oral, tid, 6 weeks
16237105|NCT01107470|Drug|hFSH（Fostimon）|After down-regulation (short protocol), all patients will be stimulated with hFSH (human-derived FSH).
16237106|NCT01107470|Drug|hFSH（Fostimon）|After down-regulation (short protocol), all patients will be stimulated with hFSH (human-derived FSH).
16237107|NCT01107470|Drug|hFSH（Fostimon）|After down-regulation (long protocol), all patients will be stimulated with hFSH (human-derived FSH).
16237108|NCT01107470|Drug|hFSH（Fostimon）|After down-regulation (long protocol), all patients will be stimulated with hFSH (human-derived FSH).
16237109|NCT01107457|Biological|Ixekizumab|Administered subcutaneously
16237110|NCT01107457|Drug|Placebo|Administered subcutaneously
16237111|NCT01107444|Drug|Docetaxel|Administered intravenously
16237112|NCT01107444|Drug|LY2181308|Administered intravenously
16237113|NCT01107431|Dietary Supplement|L-Arabinose and Chromium|Consumed 70 grams of sucrose simultaneously taking a dietary supplement
16237114|NCT01107431|Dietary Supplement|Sucrose without dietary Supplement|Repeated measures on subjects taking 70 grams of sucrose along with taking a dietary supplement containing L-Arabinose and Chromium
16237115|NCT01107418|Drug|RO5185426|dosage b) orally twice daily, days 1-15 (morning dose)
16237116|NCT01107418|Drug|RO5185426|dosage c) orally twice daily, days 1-15 (morning dose)
16237118|NCT01107418|Drug|RO5185426|960 mg orally twice daily, from day 22 onward
16237119|NCT01107418|Drug|RO5185426|dosage a) orally twice daily, days 1-15 (morning dose)
16237120|NCT01107405|Drug|Loteprednol etabonate base (QD)|Loteprednol Etabonate ophthalmic base once daily dosing for 2 weeks
16237121|NCT01107405|Drug|Loteprednol etabonate base (BID)|Loteprednol etabonate ophthalmic base BID dosing for 2 weeks
16237122|NCT01107405|Drug|Loteprednol etabonate base (QID)|Loteprednol Etabonate ophthalmic base four times/day dosing for 2 week
16237123|NCT01107405|Drug|Loteprednol etabonate suspension|Loteprednol etabonate ophthalmic suspension dosed four times daily for 2 weeks.
16237124|NCT01107405|Drug|Vehicle of loteprednol etabonate|Vehicle of loteprednol etabonate ophthalmic dosed once, twice or four times daily for 2 weeks.
16237125|NCT01107392|Drug|botulinum toxin Type A|botulinum toxin Type A total dose of 200U equally divided and administered to each lateral prostatic lobe.
16237126|NCT01107392|Drug|Normal saline|Placebo (Normal saline) equally divided and administered to each lateral prostatic lobe.
16237127|NCT01107379|Device|Relieva Balloon Sinuplasty System|Sinuplasty balloon tools for dilation of sinuses in patients with chronic rhinosinusitis
16237128|NCT01107366|Procedure|lupiae technique|it's a new hybrid technique for the treatment of aortic aneurism and dissection.
16237129|NCT01107366|Procedure|lupiae technique|"LUPIAE technique
~Hybrid repair of thoracic or thoraco-abdominal aneurysms of different etiology and type A dissections with a two-stage procedure:
~surgical arch reconstruction with a Dacron multibranched surgical prothesis
~endovascular implantation of a thoracic stent graft"
16237130|NCT01107353|Drug|Imipramine Pamoate|75 mg capsule
16237131|NCT01107340|Device|AMIStem Hip System|
16237132|NCT01107327|Procedure|FDG-PET/CT|"The study is focused on two goals, both of which use a new imaging test called PET/CT. PET/CT combines a special radioactive scan with a CT scan. PET/CT is most commonly used in medical practice to evaluate cancer. Abnormal areas such as cancer light up on the PET/CT scan. However, many doctors, including us, have noticed that PET/CT also lights up in areas of blood clot formation as well. In this study, PET/CT will be used to evaluate the two goals of this project."
16237133|NCT01107314|Other|Phlebotomy|Blood draws (total 48 cc blood)
16237134|NCT01107288|Other|Music-based multitask exercises program|Subjects are entered into a 6-month Jaques-Dalcroze eurhythmics program and are followed for an additional 6 months after the intervention period. They complete assessments at baseline, 6 and 12 months. The program consists of structured 1-hour group exercises classes, conducted weekly by an experimented instructor, that include varied multitask exercises performed to the rhythm of improvised piano music, sometimes with the manipulation of objects (e.g., instruments of percussion, balls), with gradually increasing difficulty over time. Basic exercises consist of walking following the music, responding directly to changes in music's rhythmic patterns.
16237135|NCT01107288|Other|Music-based multitask exercises program|Subjects are wait-listed to receive, 6 months after randomization, the same 6-month Jaques-Dalcroze eurhythmics program as the Intervention group. They complete assessments at baseline, 6 and 12 months.
16237136|NCT01107275|Biological|rabies vaccine|intradermal vaccination
16237137|NCT01107249|Device|Boston Scientific Ultraflex or Wallstent stents|Stent used to maintain luminal patency in esophageal strictures and occlude esophageal fistulas to reduce gastric leaks, perforations and/or fistulas.
16237138|NCT01107236|Drug|IW-6118|Single dose
16237139|NCT01107236|Drug|Matching Placebo|Single dose of matching placebo for IW-6118 and/or matching placebo for naproxen sodium
16237140|NCT01107236|Drug|Naproxen Sodium|Single dose
16237141|NCT01107223|Other|Experimental: Training to antibiotic prescription|GPs assigned to the intervention group attended a two days didactic educational meeting on evidence-based guidelines for diagnosis and treatment of acute respiratory tract infection.
16237142|NCT01107223|Other|No education on antibiotic prescription rules.|GPs assigned to control group received no specific recommendations on antibiotic prescription.
16237143|NCT01107197|Dietary Supplement|Enriched nutrition formula|oral formula enriched in arginine, zinc and antioxidant oligoelements
16237144|NCT01107197|Dietary Supplement|Control formula|Isonitrogenous isocaloric oral formula
16237145|NCT01107184|Procedure|Remote ischemic conditioning|Patients will have a automated inflator cuff placed on the upper arm during surgery. The cuff will be used to induce fore arm ischemia by inflation to 200 mmHg for 3 x 5 minutes, interspersed with 5 minutes of no-inflation and thus reperfusion.
16237146|NCT01107184|Procedure|Sham|Patients will have a automated inflator cuff placed on the upper arm during surgery which will not be inflated.
16237147|NCT01107171|Drug|Tang-min-ling pills low dosage|low dosage:6g Tang-min-ling pills every time,by 3 times every day for 12 weeks.
16237148|NCT01107171|Drug|Tang-min-ling pills high dosage|high dosage:12g Tang-min-ling pills every time,by 3 times every day for 12 weeks.
16237149|NCT01107171|Drug|Placebo|Tang-min-Ling pills analogue 6g,tid,po
16237150|NCT01107158|Biological|Whole blood sampling|Whole blood sampling for SNP polymorphism analysis
16237151|NCT01107145|Drug|Mefloquine- Artesunate|Tablets of 100 mg artesunate and 220 mg mefloquine (fixed dose combination), given once daily for 3 days.
16237152|NCT01107145|Drug|Artemether-Lumefantrine|4 tablets containing 20 mg of artemether plus 120 mg of lumefantrine per tablet twice daily for three days as 2 doses 8 hours apart on the 1st day and then 2 doses 12 hours apart on the 2nd and 3rd days, administered with a fatty meal
16237153|NCT01107145|Drug|Chloroquine|Tablets containing 250 mg Chloroquine salt given as 4 tablets at once on the first day (or 10 mg/kg) followed by 3 tablets once daily for the next 2 days (or 7,5 mg/kg)
16237154|NCT01107119|Other|integrated care pathway|communication and follow-up program for integrated care
16237155|NCT01107119|Other|usual care|
16237156|NCT01107106|Drug|ellaOne® (ulipristal acetate)|one single oral dose (30 mg tablet)
16237157|NCT01107106|Drug|ellaOne® (ulipristal acetate)|one single oral dose (30 mg tablet)
16237158|NCT01107093|Drug|CDB-2914 (ulipristal acetate)|single oral dose of 30 mg
16237159|NCT01107093|Drug|Placebo|single oral dose
16237160|NCT01107067|Drug|Sustanon|250 mg/21 days
16237161|NCT01107054|Drug|PF-00610355|An orally inhaled dose of PF-00610355 450 µg on days 1 to 4
16237162|NCT01107054|Drug|PF-00610355|An orally inhaled dose of PF-00610355 1200 µg on days 1 to 4
16237163|NCT01107054|Drug|moxifloxacin|A single oral dose of moxifloxacin 400 mg on Day 4.
16237164|NCT01107054|Drug|placebo|A single oral dose of non-matched placebo on Day 4.
16237165|NCT01107041|Behavioral|Mobilyze!|Mobilyze! delivers behavioral intervention for depression via a mobile phone, interactive website, and e-mail.
16237166|NCT01107028|Other|Standard pulmonary rehabilitation program|At the assigned time, subjects will complete a six-week, outpatient pulmonary rehabilitation program at any local center that has such a program.
16237167|NCT01107015|Device|Tailored Patient Intervention|Patients select one of two mobile phone models, receive a one-year unlimited mobile phone data and phone service plan, receive the study treatment phone software and have access to the web-based individual patient portal. Given system-driven guidance on when to test blood glucose (bg) based on disease status, medication regimen, and time of poorest control. Patients enter bg data, carbohydrates consumed, diabetes medications taken and miscellaneous comments regarding diabetes self-care. Messages are sent to the patient's mobile phone giving feedback on entered data. Entered data are captured in real-time in the web-based logbook. Patients may provide their PCPs with printed copies of their logbooks and other information but physicians do not have access to the patient portal system. Patient action plans summarizing the patient-entered data and identifying possible self-management actions for improving their diabetes control are electronically sent to the patients every 2.5 months.
16237168|NCT01107015|Device|Patient-physician intervention|"Patients select one of two mobile phone models, receive a one-year unlimited mobile phone data and phone service plan, receive the study treatment phone software and have access to the web-based individual patient portal. Given system-driven guidance on when to test blood glucose (bg) based on disease status, medication regimen, and time of poorest control. Patients enter bg data, carbohydrates consumed, diabetes medications taken and miscellaneous comments regarding diabetes self-care. Messages are sent to the patient's mobile phone giving feedback on entered data. Entered data are captured in real-time in the web-based logbook. PCPs are provided access to a web portal where they may choose to review their patients' electronic logbooks. This is raw patient data that have not been analyzed."
16237169|NCT01107015|Device|Patient and PCP intervention with analyzed data|Patients select one of two mobile phone models, receive a one-year unlimited mobile phone data and phone service plan, receive the study treatment phone software and have access to the web-based individual patient portal. Given system-driven guidance on when to test blood glucose (bg) based on disease status, medication regimen, and time of poorest control. Patients enter bg data, carbohydrates consumed, diabetes medications taken and miscellaneous comments regarding diabetes self-care. Messages are sent to the patient's mobile phone giving feedback on entered data. Entered data are captured in real-time in the web-based logbook. PCPs are provided access to a secure web portal where they can see their patients' electronic logbooks. PCPs are provided with data analysis reports. The PCP is reminded that all data analysis is based on patient-entered, unvalidated data. The PCP has the option to use this information and remains responsible for all treatment decisions.
16237170|NCT01107002|Procedure|Day 5 embryo transfer group|Embryo will transfer at blastocyst stage (day 5 after ovum pick up)
16237171|NCT01106989|Drug|Heated lidocaine/tetracaine patch|Patients will be instructed to apply one heated lidocaine 70 mg and tetracaine 70 mg topical patch directly to each trigger point identified at the Screening/Baseline Visit (up to 3 trigger points). Patches will be administered for 4 hours, 2 times per day (total of 8 hours for each trigger point per day).
16237172|NCT01106963|Procedure|Tibial intramedullary nailing|Patients' operations were performed using the peritendinous approach. A medial longitudinal incision was made, with care being taken not to damage the patellar tendon or its sheath. Standard proximal and distal locking screws were used. All patients were given postoperative instructions for thigh muscle rehabilitation and the same physiotherapy was performed after IM nailing during hospitalization. Nails were removed from some of the patients with the presence of knee pain or pain at the insertion points of the locking screws, however, no nails were removed earlier than one year postoperatively. Proof of the healed bone fracture was confirmed by radiologic examination.
16237173|NCT01106950|Biological|Natural Killer Cells|Given by infusion on Day 0. The product is T cell-depleted (CD3-) and B cell-depleted (CD19). Target dose for infusion is < or = 8 x 10^7 nucleated cells/kilogram.
16237174|NCT01106950|Drug|Fludarabine|Administered as a 1 hour intravenous infusion once a day for 5 doses beginning on day -6.
16237175|NCT01106950|Drug|Cyclophosphamide|Administered as a 2 hour intravenous infusion with high volume fluid flush and mesna per institutional guidelines on day -5 and -4 one hour after fludarabine infusion. (Day -4 administration may be omitted if patient has had a transplant in the previous 4 months.)
16237176|NCT01106950|Drug|Denileukin diftitox|12 ug/kg/day will be administered on day -1 and day -2 intravenously.
16237177|NCT01106950|Procedure|Donor lymphapheresis|Day -1 before planned NK cell infusion, the donor will undergo lymphapheresis (Removal of lymphocytes from donated blood, with the remainder of the blood retransfused into the donor).
16237178|NCT01106950|Drug|IL-2|Administered after NK cell infusion, 10 million units every other day for a total of 6 doses. (Patients weighing less than 45 kilograms will receive a dose of 5 million units/m^2 every other day for 6 doses).
16237179|NCT01106924|Other|Probiotic|daily probiotic consumption
16237180|NCT01106924|Other|Placebo|daily placebo consumption
16237181|NCT01106911|Device|tomosynthesis and screening mammography|All eligible subjects will undergo both full field digital mammography and digital breast tomosynthesis.
16237182|NCT01106898|Drug|cyclophosphamide|Given IV
16237183|NCT01106898|Drug|paclitaxel|Given IV
16237184|NCT01106898|Biological|trastuzumab|Given IV
16237185|NCT01106898|Other|laboratory biomarker analysis|Correlative studies
16237186|NCT01106885|Behavioral|Medication Care Management (MCM)|"Basic physical activity counseling
~Notify PCP and facilitate initiation of antidepressants
~Medication monitoring calls at 1, 2, 4, 6, 8, 10, and 12 weeks*
~1/mo monitoring in continuation phase (mos. 4-12)*
~Report & recommendations to PCP after each patient call
~Note: *average of 10 minutes of telephone time each (series is repeated if second antidepressant trial is needed)"
16237187|NCT01106885|Behavioral|Cognitive-Behavioral Therapy (CBT)|"Notify PCP
~CBT Manual
~Weekly CBT focused counseling for 12 weeks**
~Monthly CBT in months 4-12**
~Behavioral physical activity counseling
~Report & recommendations to PCP after each patient call
~Note: **average of 50 minutes of telephone time each"
16237188|NCT01106872|Drug|Bevacizumab, Gemcitabine, Docetaxel and Valproic Acid|
16237189|NCT01106859|Drug|zopiclone|7.5 mg tablet by mouth. Zopiclone is a commonly used hypnotic in Europe that is known to impair driving in the morning 9 hours after dosing.
16237190|NCT01106859|Drug|zolpidem tartrate sublingual tablet|3.5 mg zolpidem tartrate sublingual tablet taken either 3 or 4 hours prior to driving. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.
16237191|NCT01106859|Drug|Placebo (sublingual tablet)|Placebo matching zolpidem tartrate sublingual tablet taken either 3 or 4 hours prior to driving. Participants placed the study drug under the tongue and allowed it to dissolve there for about 2 minutes, then swallowed after dissolved.
16237192|NCT01106859|Drug|Placebo|Placebo matching zopiclone
16237193|NCT01106846|Drug|Group A: Saline Group|Saline continuous infusion
16237194|NCT01106846|Drug|Group B: 1% Ketamine group|Administration of 1% ketamine intravenously.
16237195|NCT01106833|Drug|Sirolimus + calcineurin inhibitor + prednisone|"The target serum level for sirolimus is 3-12 ng/mL. The target serum level for tacrolimus is 5-10 ng/mL. The target serum level for cyclosporine is 120-200 ng/mL.
~Prednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day."
16237196|NCT01106833|Drug|Sirolimus + prednisone|"The target serum level for sirolimus is 3-12 ng/mL.
~Prednisone is administered initially as a single early morning dose of 1 mg/kg/day (or equivalent). If prednisone at a dose of 1 mg/kg/day (or equivalent) is contraindicated, patients may begin prednisone between 0.5-1 mg/kg/day."
16237197|NCT01106820|Other|Supervised progressive resistance training|Supervised progressive resistance training
16237198|NCT01106820|Other|Supervised progressive muscle relaxation training (Jacobsen method)|Supervised progressive muscle relaxation training (Jacobsen method)
16237199|NCT01106807|Drug|Epiduo vehicle gel|500 microliters of Epiduo vehicle gel on one half-face twice daily for six weeks
16237200|NCT01106807|Drug|CD07223|500 microliters of CD07223 1.5% gel on one half-face twice daily for six weeks
16237201|NCT01106807|Drug|CD07223|500 microliters of CD07223 0.5% gel on one half-face twice daily for six weeks
16237202|NCT01106807|Drug|Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel|500 microliters Epiduo Gel on one of the half-face for the morning dose
16237203|NCT01106755|Device|gait training on ground level using BWS|An A1-B-A2 system was applied in which A1 and A2 corresponded to gait training on ground level using Body Weight Support (BWS). Each training phase was performed during 45 minutes, three times a week, for six weeks.
16237204|NCT01106755|Device|gait training on ground level using BWS associated to FES|An A1-B-A2 system was applied in which B corresponded to the training associated to Functional Electrical Stimulation. Each training phase was performed during 45 minutes, three times a week, for six weeks.
16237205|NCT01106742|Dietary Supplement|AndoSan|AndoSan, 20mlx3, 12 days
16237206|NCT01106729|Dietary Supplement|Cyanidin 3 glucoside|Ingestion of 500mg of Cyanidin 3 glucoside (a naturally occurring plant pigment)
16237207|NCT01106716|Drug|Placebo|Placebo IV Infusion
16237208|NCT01106716|Drug|KAI-1678|KAI-1678 IV Infusion
16237209|NCT01106716|Drug|Lidocaine|Lidocaine
16237210|NCT01106703|Dietary Supplement|PG102, a water soluble extract from Actinidia arguta|PG102 two tables(Actinidia arguta extract:Microcrystalline cellulose(1:1)mixed powder 1120mg) twice a day for 8weeks
16237211|NCT01106703|Other|placebo|placebo two tables(equivalent dose of Microcrystalline cellulose) twice a day for 8weeks
16237212|NCT01106690|Drug|Placebo|One matching placebo capsule orally (by mouth) once daily for 26 weeks with stable doses of metformin and pioglitazone.
16237213|NCT01106690|Drug|Canagliflozin|One 100 mg or 300 mg over-encapsulated tablet orally once daily for 52 weeks with stable doses of metformin and pioglitazone.
16237214|NCT01106690|Drug|Sitagliptin|One 100 mg over-encapsulated tablet orally once daily beginning at Week 26 until Week 52 with stable doses of metformin and pioglitazone.
16237215|NCT01106690|Drug|Metformin|The patient's stable dose of metformin background therapy should be continued throughout the study.
16237216|NCT01106690|Drug|Pioglitazone|The patient's stable dose of pioglitazone background therapy should be continued throughout the study.
16237217|NCT01106677|Drug|Placebo|One matching placebo capsule orally (by mouth) once daily for 26 weeks with protocol-specified doses of metformin immediate release.
16237218|NCT01106677|Drug|Canagliflozin|One 100 mg or 300 mg over-encapsulated tablet orally once daily for 52 weeks with protocol-specified doses of metformin immediate release.
16237219|NCT01106677|Drug|Sitagliptin|One 100 mg over-encapsulated tablet orally once daily for 52 weeks (sitagliptin 100 mg arm) or once daily beginning at Week 26 until Week 52 (placebo/sitagliptin arm). Sitagliptin will be given with protocol-specified doses of metformin immediate release.
16237220|NCT01106677|Drug|Metformin immediate release|The patient's stable dose of metformin immediate release background therapy should be continued throughout the study.
16237221|NCT01106664|Drug|ONO-7746|1mg, 2mg, 4mg, 8mg, 16mg, once daily for multiple-dose study; 4mg at a single dose for food effect study.
16237222|NCT01106664|Drug|ONO-7746|1mg, 2mg, 4mg, 8mg, 16mg once daily for multiple-dose study; 4mg at a single dose for food effect study
16237223|NCT01106651|Drug|Canagliflozin 100 mg|One 100 mg over-encapsulated tablet orally (by mouth) once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.
16237224|NCT01106651|Drug|Canagliflozin 300 mg|One 300 mg over-encapsulated tablet orally (by mouth) once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.
16237225|NCT01106651|Drug|Antihyperglycemic agent(s)|Stable doses of antihyperglycemic agents (sulfonylurea agent, thiazolidinediones, dipeptidyl peptidase 4 [DPP-4] inhibitors, metformin, insulin [all types]) and their combinations (sulfonylurea agent and insulin [all types], metformin and insulin [all types], metformin and sulfonylurea, alpha glucosidase inhibitors, thiazolidinediones, dipeptidyl peptidase 4 [DPP-4]) are used as per protocol specifications.
16237226|NCT01106651|Drug|Placebo|One matching placebo capsule orally once daily for 104 weeks with/without stable doses of antihyperglycemic agent(s) taken at the time of study entry.
16237227|NCT01106638|Behavioral|Positively Smoke Free|An eight session, group therapy intervention targeting smokers living with HIV/AIDS
16237314|NCT01105975|Drug|LY2484595|Administered daily by mouth for 12 weeks
16237228|NCT01106638|Behavioral|Standard care|Advice to quit, smoking cessation brochure, and offer of nicotine patches
16237229|NCT01106625|Drug|Canagliflozin|One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
16237230|NCT01106625|Drug|Placebo|One matching placebo capsule orally once daily for 52 weeks with protocol-specified doses of metformin and sulphonylurea.
16237231|NCT01106625|Drug|Metformin|The patient's stable dose of background metformin therapy should be continued throughout the study.
16237232|NCT01106625|Drug|Sulphonylruea|The patient's stable dose of background sulphonylurea therapy should be continued throughout the study.
16237233|NCT01106612|Procedure|Coronary CT angiography|EKG-gated, computed tomography angiography of the coronary arteries during heart rate control
16237234|NCT01106612|Procedure|Myocardial perfusion imaging|Stress radionuclide myocardial perfusion imaging
16237235|NCT01106599|Drug|GDC-0623|Repeating oral dose
16237236|NCT01106586|Drug|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR administered orally once daily
16237237|NCT01106586|Drug|ATV|Atazanavir 300 mg capsule administered orally once daily
16237238|NCT01106586|Drug|Ritonavir|Ritonavir (RTV; /r) 100 mg tablet administered orally once daily
16237239|NCT01106586|Drug|FTC/TDF|FTC/TDF 200/300 mg tablet administered orally once daily
16237240|NCT01106586|Drug|Stribild Placebo|Placebo to match Stribild administered orally once daily
16237241|NCT01106586|Drug|ATV Placebo|Placebo to match ATV administered orally once daily
16237242|NCT01106586|Drug|RTV Placebo|Placebo to match RTV administered orally once daily
16237243|NCT01106586|Drug|FTC/TDF Placebo|Placebo to match FTC/TDF administered orally once daily
16237244|NCT01106560|Procedure|Minimally Invasive Anterior Approach|Anterior minimally invasive surgery (AMIS)
16237245|NCT01106560|Procedure|Standard postero-lateral approach|
16237246|NCT01106547|Drug|Methylprednisolone 125mg|Single dose 60-90 minutes preoperatively
16237247|NCT01106547|Drug|Sodium Chloride 2 ml|Single dose 60-90 min preoperatively
16237248|NCT01106534|Drug|placebo + aspirin|This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive 18 months of placebo treatment in addition to aspirin.
16237249|NCT01106534|Drug|clopidogrel + aspirin OR prasugrel + aspirin|This population consists of subjects enrolled in the study who are free from death, MI, stroke, repeat coronary revascularization, major bleeding, and ST 12 months after stent implantation and who are compliant with 12 months of dual antiplatelet therapy following stent implantation and who are subsequently randomized to receive an additional 18 months of thienopyridine (clopidogrel or prasugrel) treatment in addition to aspirin.
16237250|NCT01106534|Device|XIENCE V Everolimus Eluting Coronary Stent System (XIENCE V EECSS)|XIENCE V Everolimus Eluting Coronary Stent System assigned to both the arms.
16237252|NCT01106508|Drug|LEQ506|
16237253|NCT01106495|Device|Enhanced External Counterpulsation (EECP)|EECP one hour per day, 5 hours a week for a total of 35- 36 hours over a 7 week period
16237254|NCT01106495|Drug|Simvastatin|Simvastatin 40 mg/d for 7 weeks as the guideline- driven standard medical treatment
16237255|NCT01106482|Other|Serology blood draw|Blood draw only, no vaccine
16237256|NCT01106469|Drug|JNJ-41443532|25mg tablet once daily
16237257|NCT01106469|Drug|JNJ-41443532|250mg tablet once daily
16237258|NCT01106469|Drug|JNJ-41443532|1500mg once daily (with 250mg tablets)
16237259|NCT01106469|Drug|JNJ-41443532|100mg tablet once daily
16237260|NCT01106469|Drug|JNJ-41443532|1000mg once daily (with 250mg tablets)
16237261|NCT01106469|Drug|Placebo|Matching placebo
16237262|NCT01106469|Drug|JNJ-41443532|500mg once daily (with 250mg tablets)
16237263|NCT01106456|Behavioral|All Nations Breath of Life (ANBL)|ANBL consists of in-person group sessions and individual telephone calls. We have successfully conducted a pilot study of ANBL and have found very promising results. At six months and 12 months post baseline, all participants will be assessed for smoking status and smoking abstinence.
16237264|NCT01106456|Behavioral|Nontailored program (NT)|"The nontailored intervention includes the medicines listed above to all participants and targeted counseling delivered by non-American Indian counselors who have worked closely with the American Indian communities and respect the cultures, values, and traditions of the Indian people. Therefore, our intervention includes the current best practice recommendations for smoking cessation. At six months and 12 months post baseline, all participants will be assessed for smoking status and smoking abstinence."
16237265|NCT01106456|Drug|Pharmacotherapy|All participants in the study will be offered pharmacotherapy (e.g. Varenicline, Bupropion, or NRT)
16237266|NCT01106443|Procedure|Total Thyroidectomy + CLND|Total thyroidectomy includes removing all possible thyroid tissue. Central lymph node dissection is a neck level 6 dissection. This includes removal of all central lymphatics from carotid artery to carotid artery and hyoid to sternum/clavicle.
16237267|NCT01106443|Procedure|Total thyroidectomy - CLND|Removal of all possible thyroid tissue without dissection of neck level 6.
16237268|NCT01106443|Procedure|Hemi-thyroidectomy + CLND|Removal of one thyroid lobe and ipsilateral central lymph nodes
16237269|NCT01106443|Procedure|Hemi-thyroidectomy - CLND|Removal of one thyroid lobe only. No lymphatic dissection.
16237270|NCT01106430|Drug|Lisdexamfetamine Dimesylate|Oral 30, 50, or 70mg once-daily for 9 weeks
16237271|NCT01106430|Drug|Atomoxetine Hydrochloride|Oral 10mg to 100mg once-daily for 9 weeks
16237272|NCT01106417|Biological|NeoFuse|Single Dose NeoFuse Surgical Implantation
16237273|NCT01106417|Device|MasterGraft Granules|Single Dose MaterGraft Granules Surgical Implantation
16237315|NCT01105975|Drug|Atorvastatin|Administered daily by mouth for 12 weeks
16237316|NCT01105975|Drug|Simvastatin|Administered daily by mouth for 12 weeks
16237274|NCT01106404|Device|RestoreSensor Neurostimulation System|"Adjustments to stimulation settings are automatic when the AdaptiveStim feature of the device is turned ON and manual when the AdaptiveStim feature of the device is turned OFF."
16237275|NCT01106391|Device|"Cordis AAA stent graft system INCRAFT TM"|
16237276|NCT01106365|Device|H-coil (Repetitive deep transcranial magnetic stimulation)|Repetitive deep transcranial magnetic stimulation of prefrontal cortex or motor cortex or sham stimulation
16237277|NCT01106352|Drug|Radium-223 dichloride (Xofigo, BAY88-8223)|Alpharadin (Radium-223 dichloride) is administered intravenously as a bolus injection.
16237278|NCT01106352|Drug|Docetaxel|Docetaxel (75 mg/m^2) will be administered intravenously every 3 weeks with 5 mg prednisone twice a day continuously and pre-medication with dexamethasone. Step-down to 60 mg/m^2 is allowed as per the approved docetaxel label.
16237279|NCT01106326|Behavioral|Intervention|"Teens participating in this study will have:
~directly observed administration of their daily preventive asthma medication at school, by the school nurse, for the first 6-8 weeks of the study
~three counseling sessions with a study nurse trained in principles of motivational interviewing (MI), that are designed to enhance the teen's motivation to change health behaviors, with a focus on adherence to evidence-based preventive care guidelines (e.g.; preventive medications)."
16237280|NCT01106287|Drug|MK-0941|A single 60, 80, 100, 120 or 140 mg oral dose of MK-0941 will be administered in each period
16237281|NCT01106287|Drug|Comparator: Placebo|a single oral placebo will be administered in the designated period (Periods 1-5)
16237282|NCT01106274|Radiation|ultraviolet-A|Corneal cross linking (C3R) with riboflavin and ultraviolet-A (UVA, 370 nm, 3mW/cm2) for 30 min
16237283|NCT01106261|Procedure|Metastasectomy|Pulmonary Metastasectomy
16237284|NCT01106261|Procedure|Active monitoring|Active monitoring
16237285|NCT01106248|Drug|Eribulin Mesylate|1.4 mg/m^2 intravenous (IV) bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
16237286|NCT01106235|Biological|therapeutic autologous lymphocytes|Given IV
16237287|NCT01106235|Biological|aldesleukin|Given SC
16237288|NCT01106235|Drug|cyclophosphamide|Given IV
16237289|NCT01106235|Procedure|biopsy|Optional correlative studies
16237290|NCT01106183|Dietary Supplement|transfer factor|capsules, 2 per day by mouth for 7 weeks.
16237291|NCT01106183|Dietary Supplement|Placebo|cornstarch, 2 capsules per day by mouth.
16237292|NCT01106170|Drug|Provex CV|dietary supplement, 2 capsules per day by mouth
16237293|NCT01106170|Other|placebo|corn starch, 2 capsules per day by mouth
16237294|NCT01106157|Drug|Anti-Thymocyte Globin (ATG)|Anti-Thymocyte Globin (ATG) will be given as 0.5/mg/kg on day 1 and 2mg/kg on day 2.
16237295|NCT01106157|Drug|Placebo|Saline infusions will be given on Day 1 and Day 2 followed by placebo injections given in identical volumes in identical syringes
16237296|NCT01106157|Drug|Pegylated GCSF|6 doses of pegylated GCSF (6mg/dose) will be given subcutaneously every 2 weeks beginning after the ATG infusion.
16237297|NCT01106131|Drug|CKD-501 0.5mg|CKD-501 0.5mg, orally, 1 tablet once a day for 24weeks or 52weeks(if extension study) with metformin.
16237298|NCT01106131|Drug|Pioglitazone 15mg|Pioglitazone 15mg, orally, 1 tablet or 2 tablet(if confirmed case) once a day for 24weeks with metformin.
16237299|NCT01106118|Drug|Vardenafil (Levitra, BAY38-9456)|Patients with diagnosis of erectile dysfunction and metabolic syndrome who get vardenafil in routine treatment as prescribed by physician
16237300|NCT01106092|Biological|GSK2036874A vaccine|Intramuscular, single dose
16237301|NCT01106092|Biological|Zilbrix™/Hib vaccine|Intramuscular, single dose
16237302|NCT01106092|Biological|Poliorix™|Intramuscular, single dose
16237303|NCT01106079|Drug|Intensive management or Tight control|Those subjects randomised to the intensive management or tight control arm will be reviewed every 4 weeks (by the Principal Investigator at each site or a designated researcher) and will be treated according to a rapidly escalating regime, involving standard DMARDs and biologics. Initial therapy will be with oral methotrexate, increasing in dose rapidly over the first 8 weeks of the study. From the 12 week visit onwards, escalation of therapy in this arm will be performed if subjects do not meet the objective target of Minimal Disease Activity. Initial escalation will be to combination DMARD therapy. If patients in the tight control arm fail to meet the MDA criteria and fulfil the NICE criteria for the use of TNF blockers in psoriatic arthritis at 24 weeks, then they will be offered treatment with these medications. Therapy will continue to be modified throughout the 48 week follow-up until a state of minimal disease activity is reached.
16237304|NCT01106079|Drug|Standard management - Control group|The control group will be seen every 12 weeks in a general rheumatology clinic and will receive standard care, involving standard DMARDs and biologics as appropriate. Treatment will be prescribed as felt appropriate by the treating physicians with no set protocol and no restrictions.
16237305|NCT01106066|Drug|Oxaliplatin, S-1, radiotherapy|Radiotherapy 4000cGy/20 fractions S-1 ( )mg/m2 po bid daily during radiotherapy Oxaliplatin at four dose levels (___mg/m2 iv weekly x 4 weeks)
16237306|NCT01106053|Drug|Pramipexole|Pramipexole tablet titrated up to a maximum dosage of 0.5 mg three times daily (1.5 mg/day).
16237307|NCT01106040|Drug|Lymphoseek|The total volume of Lymphoseek injection will be between 0.1 - 1.0 mL.
16237308|NCT01106027|Drug|Eculizumab|Eculizumab 900 mg and 1200 mg, administered intravenously (IV)
16237309|NCT01106014|Drug|Selexipag|Selexipag 200 µg tablets
16237310|NCT01106014|Drug|Placebo|Placebo tablets matching selexipag
16237311|NCT01106001|Drug|Levobupivacaine|The treatment group received 150mg of levobupivicaine in 60mls of 0.9% saline. This was injected intra-operatively through the medial and anterior capsular spaces in the region of the obturator and femoral nerves and also around the short rotators and gluteus maximus in the region of the inferior and superior gluteal nerves. The timing of this was after insertion of the acetabular component. 10mls was then infiltrated around the tensor fascia lata and subcutaneously prior to closing the wound.
16237312|NCT01106001|Drug|Saline|The placebo group received 60mls of 0.9% saline injected intra-operatively through the medial and anterior capsular spaces in the region of the obturator and femoral nerves and also around the short rotators and gluteus maximus in the region of the inferior and superior gluteal nerves. The timing of this was after insertion of the acetabular component. 10mls was then infiltrated around the tensor fascia lata and subcutaneously prior to closing the wound.
16237313|NCT01105988|Other|Radiologic exams|FLT PET scan x 2 MRI scan x 2
16237317|NCT01105975|Drug|Rosuvastatin|Administered daily by mouth for 12 weeks
16237318|NCT01105975|Drug|Placebo for LY2484595|Administered daily by mouth for 12 weeks
16237319|NCT01105975|Drug|Placebo for Statins|Administered daily by mouth for 12 weeks
16237320|NCT01105949|Device|Marketed nasal strip|Marketed nasal strip
16237321|NCT01105949|Device|NexGen AB 2R11|Nasal strip prototype
16237322|NCT01105949|Device|NexGen JB Organic PET/PE|Nasal strip
16237323|NCT01105936|Drug|Paracetamol|665 mg sustained release paracetamol caplets
16237324|NCT01105936|Drug|Placebo|Placebo caplets
16237325|NCT01105923|Other|MAPLE|MAPLE is a CDS intervention within the EHR that will alert providers to problem lists gaps and present an opportunity to correct them.
16237326|NCT01105910|Other|Systane Ultra Lubricant Eye Drops|1 to 2 drops in each eye 4 times per day for 30 days
16237327|NCT01105910|Other|Sensitive Eyes Eye Drops (Bausch & Lomb)|1 to 2 drops in each eye 4 times per day for 30 days
16237328|NCT01105897|Procedure|Endometriosis surgery|Complete surgical excision of all visible endometriosis by multidisciplinary approach
16237329|NCT01105884|Procedure|Normal Saline|All the subjects in Group 1 will be treated with Normal Saline for healing of their diabetic foot ulcer
16237330|NCT01105884|Procedure|Biatin Ag (Foam)|All the subjects will be treated with Biatin Ag (Foam)
16237331|NCT01105884|Procedure|Hydrocolloid|All the subjects in this group will be treated with Hydrocolloid
16237332|NCT01105884|Procedure|Hydrogel|All the subjects in this group will be treated with Hydrogel
16237333|NCT01105884|Procedure|Ceredak|All the subjects in this group will be treated with Micro-porous Ceramic Wound Dressing
16237334|NCT01105871|Drug|naloxone|4 mg naloxone in 10 ml saline given iv bolus
16237335|NCT01105871|Drug|Placebo|10 ml of normal saline iv bolus
16237336|NCT01105832|Drug|Teriparatide|Teriparatide (Forsteo) 20 micrograms daily during four weeks
16237337|NCT01105819|Procedure|Lactobacillus plantarum 299 for oral care|The study group will be attended in the same manor but the swabs used for cleansing are soaked with carbonated water directly from freshly opened bottles. As the final part of the procedure oral mucosal surfaces are pencilled with a suspension of the probiotic bacterium Lactobacillus plantarum 299 Cultures from the oropharynx and tracheal secretions are taken at inclusion (day 1) and then on days 2,3,5,7,10,14 and 21 or before extubation if this occurs on a non-culture day
16237338|NCT01105819|Procedure|Chlorhexidine for standard oral care|"A The control group will receive the standard oral care of the department (general ICU, Lund University Hospital).
~This includes suction of secretions, brushing of teeth cleansing of the oral cavity with swabs soaked with a chlorhexidine solution. This procedure is performed twice a day. In between, suction whenever needed and cleansing with swabs soaked with carbonated bottled water is performed Cultures from the oropharynx and tracheal secretions are taken at inclusion (day 1) and then on days 2,3,5,7,10,14 and 21 or before extubation if this occurs on a non-culture day"
16237339|NCT01105806|Behavioral|(CPR) video and questionnaires|Baseline Assessments (10 mins),Intervention:CPR video or script (5 mins) Post intervention assessments (10 mins), Longitudinal chart review follow-up (6 months)
16237340|NCT01105806|Behavioral|cardiopulmonary resuscitation (CPR) narrative script and questionnaires|Baseline Assessments (10 mins),Intervention:CPR video or script (5 mins) Post intervention assessments (10 mins), Longitudinal chart review follow-up (6 months)
16237341|NCT01105793|Drug|Danazol|High dose FP1198 applied once daily to both breasts for 6 treatment cycles.
16237342|NCT01105780|Drug|Placebo|Matching placebo
16237343|NCT01105780|Drug|JNJ-41443532|250mg tablet once daily for 1 day
16237344|NCT01105767|Drug|Chlorhexidine gluconate|Self applied chlorhexidine body wash (4% chlorhexidine gluconate, Hibiclens®, Mӧlnlycke Heath Care, Norcross, Georgia) once a week to wash/cover the body (except the face and genitalia).
16237345|NCT01105767|Other|Supplemental training, education and hygiene|Supplemental SSTI education for trainees and drill sergeants included pocket cards and posters. Drill sergeants received briefings on SSTI and skin inspection/minor wound care. Trainees were instructed to take an additional 10-minute shower with soap and a wash cloth every week. They were also issued a first aid kit.
16237346|NCT01105754|Behavioral|Multifaceted Prompting Intervention MPI|"Practices assigned to the MPI group will receive a simple prompt given to the provider at the time of the visit with information regarding the child's symptoms, medication use, environmental exposures, and recommendations for guideline-based preventive care. Practices will receive brief interactive seminars, resource guides, access to free asthma education programs, and practice-level feedback regarding their performance on key outcome measures.
~Caregivers will receive a simple prompt, community resources, and a blank asthma action plan form."
16237347|NCT01105728|Procedure|Endoscopic resection|Endoscopic resection of the gastric subepithelial mass
16237348|NCT01105702|Drug|Temozolomide|
16237349|NCT01105702|Drug|Bevacizumab|
16237350|NCT01105702|Drug|Lithium Carbonate|
16237351|NCT01105702|Radiation|Radiation|
16237352|NCT01105676|Procedure|skin biopsy|Two skin biopsies will be taken one time
16237353|NCT01105663|Other|Pharmacokinetic Sampling and pharmacogenetic analysis|Pharmacogenetic and pharmacokinetic samples will be obtained from a peripheral catheter, central catheter, or venipuncture coordinated with scheduled phlebotomies. Pharmacokinetic and pharmacogenetic analyses will be performed. Pharmacodynamic data will be collected.
16237354|NCT01105650|Drug|Fludarabine|Administered intravenously, 25 mg/m^2, days -6 through -2 (5 days).
16237355|NCT01105650|Drug|Cyclophosphamide|Administered intravenously, 60 mg/kg, days -5 and -4.
16237356|NCT01105650|Drug|Cyclosporine|Administered intravenously, CsA 1.5 mg/kg for target dose range of 150-250 ng/mL day -3 through day +14
16237357|NCT01105650|Biological|Natural killer cells|Administered by infusion over less than 1 hour, no more than 8.0 x 10^7 cells/kg will be given.
16237358|NCT01105650|Drug|IL-2|Will be given subcutaneously at 9 million units 3 times a week for a total of 6 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, will be given at 5 million units/m^2 3 times per week for 6 doses).
16237359|NCT01105650|Drug|Methylprednisolone|Administered intravenously (IV) 10 mg/kg Days -2 to +4 and 1 mg/kg Days +5 to +9
16237360|NCT01105650|Drug|Methylprednisolone|Administered intravenously (IV) 1 mg/kg Days -2 to +9
16237797|NCT01102478|Drug|losartan potassium / hydrochlorothiazide|100 mg / 25 mg tablet
16237361|NCT01105650|Drug|Interleukin-2|Will be given subcutaneously at million units 3 times a week for a total of 3 doses, beginning 4 hours after NK cell infusion. (For patients weighing less than 45 kilograms, will be given at 3 million units/m^2 3 times per week for 6 doses).
16237362|NCT01105637|Behavioral|Augmented Exercise Program|12 week (3 x per week) exercise prescription
16237363|NCT01105624|Drug|azithromycin ophthalmic solution, 1%|1 drop BID for the first 2 days and then 1 drop QD for the remainder of treatment period (29 ± 1 day)
16237364|NCT01105624|Drug|Visine® for Contacts®|1-2 drops QID for the treatment period (29 ± 1 day)
16237365|NCT01105611|Drug|Raltegravir|400mg orally twice daily. Number of cycles: unless toxicity or treatment failure occurs, there will be no anticipated treatment discontinuation.
16237366|NCT01105611|Drug|Atazanavir/Ritonavir|Atazanavir 300mg orally once daily boosted with Ritonavir orally 100mg once daily. Number of cycles: unless toxicity or treatment failure occurs, there will be no anticipated treatment discontinuation.
16237367|NCT01105598|Drug|ETC-1002 or placebo|ETC-1002 (ascending dose), daily for 14 days
16237368|NCT01105598|Drug|ETC-1002 or placebo|ETC-1002 (optimized dose), daily for 28 days
16237369|NCT01105598|Drug|ETC-1002 or placebo|ETC-1002 (20 mg), daily for 14 days
16237370|NCT01105585|Device|Tecnis 1-piece Aspheric Acrylic (ZCB00) IOL|Tecnis 1-piece Aspheric Acrylic (ZCB00) intraocular lens implanted in the capsular bag during cataract surgery. The IOL is intended for the lifetime of the patient.
16237371|NCT01105585|Device|AcrySof Natural IQ (SN60WF) IOL|AcrySof Natural IQ (SN60WF) intraocular lens implanted in the capsular bag during cataract surgery. The IOL is intended for the lifetime of the patient.
16237372|NCT01105572|Device|Intel Health Guide|An Internet-connected device with member-customized protocols and response algorithms. Participants interact with the Intel HealthGuide device, receiving immediate feedback, and also transmitting blood pressure, weights and responses to questions to a site monitored by their nurse case manager.
16237373|NCT01105572|Other|Case Management|Specialized Medicare Case Managers review and coordinate services for members with multiple and complex needs with identified gaps in their care Medicare Case Management staff strives to enhance the member's quality of life, support continuity of care, facilitate provision of services in the appropriate setting and manage cost and resource allocation to promote quality, cost-effective outcomes. Specially trained Medicare Case Managers collaborate with the member, family, caregiver, member authorized representative, treating practitioner, health care provider, community services and other Aetna programs to coordinate care, with a focus on member education and maximizing quality outcomes.
16237374|NCT01105546|Drug|recombinant activated factor VII|90 µg/kg/day i.v.
16237375|NCT01105546|Drug|recombinant activated factor VII|treatment of bleeding episodes with 270 µg/kg (first/single dose) or 90 µg/kg i.v. every 2-3 hours until bleeding resolution
16237376|NCT01105533|Drug|PF-00337210|0.67mg Capsule Once Daily (Accelerated Dose Escalation) Continuous
16237377|NCT01105533|Drug|PF-00337210|1mg Capsule Once Daily (Dose Escalation) Continuous
16237378|NCT01105533|Drug|PF-00337210|2mg Capsule Once Daily (Dose Escalation) Continuous
16237379|NCT01105533|Drug|PF-00337210|4mg Capsule Once Daily (Dose Escalation) Continuous
16237380|NCT01105533|Drug|PF-00337210|6mg Capsule Once Daily (Dose Escalation) Continuous
16237381|NCT01105533|Drug|PF-00337210|9mg Capsule Once Daily (Dose Escalation) Continuous
16237382|NCT01105533|Drug|PF-00337210|8mg Capsule Once Daily (Dose Escalation) Continuous
16237383|NCT01105533|Drug|PF-00337210|4mg Capsule Twice Daily (Dose Escalation) Continuous
16237384|NCT01105533|Drug|PF-00337210|6mg Capsule Twice Daily (Dose Escalation) Continuous
16237385|NCT01105533|Drug|PF-00337210|6mg Capsule Twice Daily (Dose Expansion) Continuous
16237386|NCT01105520|Procedure|Diagnostic|SCIM Spinal Cord Independence Measure ASIA scale American Spinal Injury Association
16237387|NCT01105507|Drug|canakinumab (company code: ACZ885D)|
16237388|NCT01105494|Drug|epoetin beta [NeoRecormon]|As prescribed by physician
16237389|NCT01105481|Drug|Amisulpride add-on|At the beginning of the treatment phase (day 1), subjects in the combination treatment group will be started with adjunctive amisulpride, with a starting dose of 200 mg per day. Amisulpride is planned to increase to 400 mg/day on day 8, 600mg/day on day 15 and 800 mg/day on day 22, according to the subjects' responses and tolerability. All of the add-on amisulpride will be provided to subjects at night. To permit dose adjustment and ensure double-blind procedure, 200mg amisulpride is packed in capsules identical to those used for the placebo.
16237390|NCT01105481|Drug|Placebo add-on|For subjects randomly allocated to the placebo treatment group, they will be added with one capsule of placebo from Day 1. On Day 8, Day 15 and Day 22, the placebo will be increased to 2, 3 and 4 capsules, respectively. and adjunctive amisulpride, with a starting dose of 200 mg per day. Amisulpride is planned to increase to 400 mg/day on day 8, 600mg/day on day 15 and 800 mg/day on day 22, according to the subjects' responses and tolerability. To permit dose adjustment and ensure double-blind procedure, 200mg amisulpride is packed in capsules identical to those used for the placebo.
16237391|NCT01105468|Device|Breath Collecting Unit|Collect two breath gas samples per patient on one day before surgery
16237392|NCT01105468|Device|Breath Collecting Unit|Collect two or more breath gas samples on different days during adjuvant or neo-adjuvant therapy.
16237393|NCT01105455|Other|Nutrition education|Group nutrition classes supplemented by handouts and provision of key study foods.
16237394|NCT01105429|Drug|BMS-820132|Oral Solution, Oral, 0.3 mg, once daily, 1 day
16237395|NCT01105429|Drug|BMS-820132|Oral Solution, Oral, 1.0 mg, once daily, 1 day
16237396|NCT01105429|Drug|BMS-820132|Oral Solution, Oral, 3 mg, once daily, 1 day
16237397|NCT01105429|Drug|BMS-820132|Oral Solution, Oral, 10 mg, once daily, 1 day
16237398|NCT01105429|Drug|BMS-820132|Oral Solution, Oral, 30 mg, once daily, 1 day
16237399|NCT01105429|Drug|BMS-820132|Oral Solution, Oral , 75 mg, once daily, 1 day
16237400|NCT01105429|Drug|BMS-820132|Oral Solution, Oral, 150 mg, once daily, 1 day
16237401|NCT01105429|Drug|BMS-820132|Oral Solution, Oral, 300 mg, once daily, 1 day
16237402|NCT01105429|Drug|BMS-820132|Capsule, Oral, (TBD), once daily, 2 days
16237403|NCT01105429|Drug|Placebo|Oral Solution, Oral, 0mg, once daily, 1 day
16237404|NCT01105429|Drug|Placebo|Capsule, Oral, (TBD), once daily, 2 days
16240280|NCT01083589|Drug|Imatinib Mesylate|Oral 400 mg daily
16237405|NCT01105416|Behavioral|Brief Prevention Intervention (BPI)|Brief Prevention Intervention: Participants will receive the BPI, a brief, family-focused prevention intervention in the Pediatric ED. The session will be comprised of parent-targeted skill building directed primarily at parental monitoring and the importance of parent-adolescent communication as the precursor to successful monitoring.
16237406|NCT01105416|Behavioral|ESC|Enhanced standard care
16237407|NCT01105403|Drug|POL6326|IV infusion of POL6326 followed by apheresis to collect mobilized stem cells from peripheral blood
16237408|NCT01105390|Biological|rilotumumab|Given IV
16237409|NCT01105390|Drug|cisplatin|Given IV
16237410|NCT01105390|Drug|pemetrexed disodium|Given IV
16237411|NCT01105390|Other|laboratory biomarker analysis|Correlative studies
16237412|NCT01105377|Drug|entinostat|Given orally
16237413|NCT01105377|Drug|azacitidine|Given SC
16237414|NCT01105377|Other|laboratory biomarker analysis|Correlative studies
16237415|NCT01105364|Drug|antiangiogenesis therapy|
16237416|NCT01105364|Drug|stabilized sulphur hexafluoride microbubble-based contrast agent|
16237417|NCT01105364|Other|imaging biomarker analysis|
16237418|NCT01105364|Other|pharmacological study|
16237419|NCT01105364|Procedure|computed tomography|
16237420|NCT01105364|Procedure|magnetic resonance imaging|
16237421|NCT01105351|Dietary Supplement|folic acid plus B6 and B12|folic acid 400 µg plus vitamin B12 plus B6
16237422|NCT01105351|Dietary Supplement|folic acid|folic acid 400 µg
16237423|NCT01105338|Behavioral|Green tea drink|Green tea drink
16237424|NCT01105338|Dietary Supplement|green tea capsules|green tea capsules
16237425|NCT01105338|Other|Green tea placebo capsules|Green tea placebo capsules
16237426|NCT01105338|Dietary Supplement|Lycopene capsules|Lycopene capsules
16237427|NCT01105338|Other|Lycopene placebo capsules|Lycopene placebo capsules
16237428|NCT01105338|Other|Tomato rich diet|Tomato rich diet
16237429|NCT01105312|Drug|letrozole|
16237430|NCT01105312|Drug|panobinostat|
16237431|NCT01105312|Genetic|RNA analysis|
16237432|NCT01105312|Genetic|microarray analysis|
16237433|NCT01105312|Genetic|reverse transcriptase-polymerase chain reaction|
16237434|NCT01105312|Other|enzyme-linked immunosorbent assay|
16237435|NCT01105312|Other|immunohistochemistry staining method|
16237436|NCT01105312|Other|laboratory biomarker analysis|
16237437|NCT01105299|Drug|CJ anastrozole 1 mg tablet|
16237438|NCT01105286|Drug|Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues|Once daily application
16237439|NCT01105273|Biological|anti-thymocyte globulin|On days -3 to -1
16237440|NCT01105273|Biological|filgrastim|Beginning on day 4 and continuing until blood counts recover
16237441|NCT01105273|Drug|Fludarabine|30mg/M2 once daily IV on days -6 to -2
16237442|NCT01105273|Drug|Cyclophosphamide|60 mg/kg IV on day-3 and -2
16237443|NCT01105273|Procedure|CD3±CD19 depleted hematopoietic stem cell transplantation|Immunogenetic depletion on CliniMACS
16237444|NCT01105247|Drug|PCI-32765|420 mg daily or 840 mg daily
16237445|NCT01105234|Drug|Six different calcipotriol ointment formulations, and two currently marketed topical vitamin D analogues.|
16237446|NCT01105221|Device|Acupuncture|Participants, allocated to this group, will have twelve times of acupuncture treatment in four weeks. Seventeen acupuncture points, which are both BL2, GB14, TE23, Ex1, ST1, GB20, LI4, LI11 and single GV23, will be selected and disposable 0.20*30mm acupuncture needles(Dongbang Co., Korea) will be inserted on these points. Strong 'deqi' sensation will be induced by twisting acupuncture needles and retained for 20 minutes before removed.
16237447|NCT01105221|Drug|Refresh Plus|Participants, allocated to this group, will be offered preservative-free and single-use Refresh plus (Sodium carboxymethylcellulose). They should use artificial tear in both eyes at least once a day for four weeks.
16237448|NCT01105208|Drug|Cephalexin suspension (Optocef, BAYO5448 )|Single dose of 500 mg / 10 mL
16237449|NCT01105208|Drug|Cephalexin suspension (Keflex)|Single dose of 500 mg / 20 mL
16237450|NCT01105195|Other|DuraPrep|DuraPrep is used for skin preparation prior to surgery.
16237451|NCT01105195|Other|ChloraPrep|ChloraPrep is used for skin preparation prior to surgery.
16237452|NCT01105182|Procedure|Radiofrequency Ablation|Radiofrequency ablation is an inpatient procedure typically requiring one overnight stay in the hospital.
16237453|NCT01105169|Dietary Supplement|Magnesium glycinate|Oral administration of magnesium glycinate daily for 12 weeks
16237454|NCT01105169|Dietary Supplement|Placebo|Oral administration of identical-appearing placebo daily for 12 weeks
16237455|NCT01105156|Behavioral|VEW Questionnaire|Patient Self reported questionnaire filled in.
16237456|NCT01105143|Behavioral|multimodal lifestyle intervention|multimodal lifestyle intervention will be performed to reduce body weight
16237457|NCT01105143|Behavioral|placebo|no intervention, only follow up
16237458|NCT01105130|Other|Placebo|Given orally
16237459|NCT01105130|Drug|Oral L-Arginine|Given orally 3 capsules ArginMax and 3 Placebo capsules
16237460|NCT01105130|Drug|Oral L-Arginine|Patients will take 6 capsules of ArginMax twice daily
16237461|NCT01105117|Drug|ACT-385781A (Actelion Epoprostenol)|per Prescribing Information
16237462|NCT01105117|Drug|Flolan®|per Prescribing Information
16237463|NCT01105104|Device|MedMinder System|Participants will receive a fully activated reminder unit as well as at least one call per month from a counselor.
16237464|NCT01105104|Device|MedMinder System - deactivated|Participants will receive a one-way reminder unit that will remotely transit information on medication adherence
16237465|NCT01105091|Drug|ACT-385781A (Actelion Epoprostenol)|per Prescribing Information
16237466|NCT01105091|Drug|Flolan®|Per Prescribing Information
16237467|NCT01105078|Procedure|Flow rate|Different flow rate during cardiopulmonary bypass
16237468|NCT01105065|Drug|brimonidine 0.15%|One drop in each eye three times a day for 8 weeks.
16237469|NCT01105052|Behavioral|Self-help CBT-I|Comparison between Bibliotherapy with and without support to a wait-list control group
16237700|NCT01103297|Device|Variable Angle Distal Radius Plate ® (Surgery)|Fracture reduction with distal radius plate
16237470|NCT01105026|Device|Alveolar Bone Defect Regeneration Following Tooth Extraction|"Patients underwent surgery under local anesthesia and minimally invasive periotomy was carried out with a surgical blade. Atraumatic extraction with forceps was performed. The extraction socket was carefully curetted to remove the granulation tissue and was rinsed with a physiologic solution. To evaluate the eligibility of the surgical site, the alveolar walls integrity was checked clinically and by means of extemporaneous peri-apical radiography.
~Then, the socket was filled to the bone margin with Inion BioRestore™ (granules size 1 to 2 millimetres). Finally, single interrupted (5-0) sutures were tightened to promote the stability of grafted particles. Ten days after the surgery, sutures were removed."
16237471|NCT01105013|Drug|Clotrimazole|Apply the product in sufficient quantity to cover the affected area 2 times daily (every 12 hours) for 60 days.
16237472|NCT01104987|Drug|alendronate|One tablet of alendronate à 70 mg once a week during two years.
16237473|NCT01104961|Device|Contact lens packaging solution|These test solutions are the intervention being tested.
16237474|NCT01104961|Device|Balanced salt solution (BSS)|BSS is isotonic to the tissues of the eyes.
16237475|NCT01104948|Drug|DA-8031|
16237476|NCT01104948|Drug|Placebo|
16237477|NCT01104935|Drug|trastuzumab monotherapy|
16237478|NCT01104935|Drug|trastuzumab and chemotherapy|
16237479|NCT01104922|Other|Cetuximab and stereotactic radiosurgery|Treatments Administered: - Fractionated stereotactic radiosurgery, 8.0 Gy per fraction for 5 fractions (total: 40.0 Gy); - Cetuximab will be administered for 3 weekly doses commencing one week prior to stereotactic radiosurgery treatment as follows: * Cetuximab 400 mg / m2 day -7 (1 week prior to initiation of radiosurgery) * Cetuximab 250 mg/m2 days 0 and +8 (i.e. during the first and second week of fractionated stereotactic radiosurgery) Cetuximab will be administered at 400 mg/m2 IV over 120 minutes on day -7 (loading dose) and 250 mg/m2 IV on days 0 and 8 during the course of stereotactic radiosurgery. Administration of cetuximab may or not be the same day that a fraction of SRS is given. Infusion reactions may occurring during the administration of cetuximab and rarely post-infusion.
16237480|NCT01104909|Procedure|Clinical|Each patient will be submitted a clinical evaluation, considering signals of overload.
16237481|NCT01104909|Device|electrical bioimpedance|From electrical bioimpedance data, will be fixed a revised dry weight for each patient.
16237482|NCT01104896|Drug|Nicotine patch|One or two 15 mg nicotine patch(es) applied from 6am to 10 pm during 21 days
16237483|NCT01104896|Drug|Placebo|One or two placebo patch(es) applied from 6am to 10 pm each day for 21 days
16237484|NCT01104883|Procedure|Adductor-Canal-Blockade|US-guided Adductor-Canal-Blockade with ropivacaine 7,5 mg/ml
16237485|NCT01104883|Procedure|Adductor-Canal-blockade with saline|US-guided Adductor-Canal-blockade with saline
16237486|NCT01104870|Drug|UT-15C|oral
16237487|NCT01104857|Procedure|diaphragm muscle biopsy|Biopsy is obtained for biochemical analysis
16237488|NCT01104857|Procedure|Diaphragm muscle biopsy|Biopsy is obtained for biochemical analysis
16237489|NCT01104844|Drug|Full Dose Strength|Acetaminophen + ibuprofen, 2 tablets every 6 hours, with food for 24 hours (i.e a total of 4 x 1000/300 mg doses of study drug comprising of 8 tablets)
16237490|NCT01104844|Drug|Quarter dose strength|Investigational drug quarter dose strength (acetaminophen 125mg + ibuprofen 37.5mg) i.e. 2 tablets equating to 1/4 the dose in the standard investigational drug.
16237491|NCT01104844|Drug|Half dose strength|Investigational drug half dose strength (acetaminophen 250mg + ibuprofen 75mg) i.e. 2 tablets equating to 1/2 the dose in the standard investigational drug
16237492|NCT01104844|Drug|Acetaminophen standard dose|Acetaminophen standard dose 500mg i.e. 2 tablets equating to the same acetaminophen dose as in the standard investigational drug
16237493|NCT01104844|Drug|Ibuprofen low dose|Ibuprofen low dose 150mg tablet i.e. 2 tablets equating to the same ibuprofen dose as in the standard investigational product
16237494|NCT01104844|Drug|Ibuprofen high dose|Ibuprofen high dose 300mg i.e. 2 tablet equating to twice the ibuprofen dose as in the standard investigational drug
16237495|NCT01104844|Drug|Placebo|2 placebo tablets
16237496|NCT01104831|Device|Cryotherapy|cooled sleeve placed over fracture site.
16237497|NCT01104831|Device|Room temperature cuff|sleeve with room temperature water placed over fracture site.
16237498|NCT01104818|Behavioral|Siblings in foster care curriculum, Parent Management Training|Each year, approximately 800,000 youth are cared for in foster homes across the nation. About 70% of these youth are known to suffer from mental health and educational disabilities and frequently transition to adulthood with lifelong deficits. The majority of youth in foster care have siblings in care. It is anticipated that the proposed intervention will significantly improve key outcomes for youth in the study and will provide much needed information on best practices to help youth in foster care.
16237499|NCT01104805|Behavioral|Therapeutic Education System (TES)|Participants will received modified treatment-as-usual plus the computerized psychosocial intervention (Therapeutic Education System), including contingency management. Participants will be asked to use the self-directed TES intervention twice weekly and will be asked to complete 2 modules during each session (for a total of 4 modules per week) during the 12-week intervention. Participants will receive incentives contingent primarily upon abstinence from drugs of abuse and, secondarily, upon completion of TES modules.
16237500|NCT01104805|Behavioral|Treatment-as-Usual (TAU)|Participants in this condition will receive TAU, consisting of standard treatment offered at each collaborating CTP and will reflect the model of treatment typically provided to most individuals in outpatient, community-based substance abuse treatment settings in the U.S. These sessions will consist of a combination of group and individual counseling.
16237501|NCT01104792|Drug|Cariprazine|Cariprazine was supplied in capsules.
16237502|NCT01104779|Drug|Cariprazine|Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
16237503|NCT01104779|Drug|Placebo|Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
16237504|NCT01104766|Drug|Cariprazine|Patients who meet eligibility criteria will be administered a once daily oral dose of cariprazine for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
16237505|NCT01104766|Drug|Aripiprazole|Patients who meet eligibility criteria will be administered a once daily oral dose of aripiprazole for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
16237506|NCT01104766|Drug|Placebo|Patients who meet eligibility criteria will be administered a once daily oral dose of placebo for six weeks. Upon completion of the study or early termination, patients will undergo a two week safety follow-up period.
16237507|NCT01104740|Other|Biological sample collection|Blood (serum) sample collection
16237508|NCT01104727|Procedure|4-Ports Cholecystectomy (4PC)|a 12mmHg pneumoperitoeum is created either by a 10mm umbelical Hasson's port or by a Verress needle followed by a 10 mm umbelical port insertion; further one 10mm and two 5mm ports are placed according to the preferred technique. A straight or angulated laparoscope may be used. Laparoscopic graspers, monopolar hook, bipolar forceps, scissors and 10mm clips-applier are used. A plastic bag system might be used for gall bladder extraction if necessary. In both 10 and 12mm accesses, fascia is sutured with resorbable sutures. Skin is secured by either metallic agraffes or interrupted sutures.
16237509|NCT01104727|Procedure|Single-Port Cholecystectomy (SPC)|"a 2.5cm long skin incision around the umbilicus is performed. The subcutaneous tissue is dissected, the muscular fascia exposed and incised along the middle line (linea alba) respecting the muscular tissue. Peritoneum is identified and incised. The Single-Port device is inserted and anchored.
~In order to retract the gallbladder a transcutaneous suture is placed in the right hypocondrium with a straight needle and a monofilament thread which are passed through the fundus and knotted outside the skin. The following steps reproduce the traditional laparoscopic cholecystectomy. Each centre will be left free to use dedicated instruments and which or traditional laparoscopic ones."
16237510|NCT01104701|Drug|exenatide once weekly|subcutaneous injection, 2 mg, once a week
16237511|NCT01104701|Drug|exenatide once monthly suspension|subcutaneous injection, low dose, once a month
16237512|NCT01104701|Drug|exenatide once monthly suspension|subcutaneous injection, medium dose, once a month
16237513|NCT01104701|Drug|exenatide once monthly suspension|subcutaneous injection, high dose, once a month
16237514|NCT01104675|Drug|ENMD-2076|275 mg (or 250 mg for BSA < 1.65) per day in oral capsules in 28 day continuous cycles
16237515|NCT01104662|Drug|Vancomycin|
16237516|NCT01104662|Drug|Daptomycin|
16237517|NCT01104662|Drug|Semi-Synthetic Penicillin|
16237518|NCT01104649|Drug|riluzole|Study drug will be orally dispensed in doses of 50 mg twice daily for 12 months.
16237519|NCT01104649|Drug|Placebo comparator|Study drug will be orally dispensed in doses of 50 mg twice daily for 12 months.
16237520|NCT01104636|Drug|Varenicline|varenicline tablets prescribed as per local German SmPC for 12 weeks duration
16237521|NCT01104610|Device|Breas Vivo 40|The Vivo 40 will be used either in CPAP mode, PSV mode without Target Volume or PSV mode with Target Volume
16237522|NCT01104597|Procedure|Flow Mediated Doppler (FMD)|Non-invasive assessment of flow-mediated dilation (FMD) will be performed using brachial artery ultrasound.
16237523|NCT01104597|Drug|Nitroglycerin 0.4 mg sublingual|Nitroglycerin 0.4 mg (a small tablet that dissolves under the tongue) will be given to dilate the arteries. Images of the arm will be recorded via non-invasive flow-mediated doppler for 5 minutes to assess for endothelium dysfunction. as outlined above.
16237524|NCT01104584|Drug|Gadobutrol (Gadavist, Gadovist, BAY86-4875)|A single bolus injection of gadobutrol 1.0 M; 0.1 mmol/kg body weight
16237525|NCT01104571|Biological|trastuzumab|Trastuzumab 6mg/kg iv given on days 1 & 8 pre-surgery & one dose of 2mg/kg iv between days 15-19 post surgery
16237526|NCT01104571|Drug|lapatinib ditosylate|"Part 1: Lapatinib 1500mg/day p.o. continuously for 28 days. Should start 11 days (+2 or -1 day) before the scheduled surgery.
~Part 2: Lapatinib 1000mg/day p.o. continuously for 28 days. Should start 11 days (+2 or -1 day) before the scheduled surgery."
16237527|NCT01104571|Other|laboratory biomarker analysis|
16237528|NCT01104571|Procedure|adjuvant therapy|
16237529|NCT01104571|Procedure|neoadjuvant therapy|
16237530|NCT01104571|Procedure|therapeutic conventional surgery|therapeutic conventional surgery
16237531|NCT01104558|Drug|Bisoprolol|Bisoprolol will be given in a starting dose of 1.25 milligram (mg) once daily for two weeks and if it is well tolerated, the dose will be increased to 2.5 mg, 3.75 mg, 5 mg once daily in intervals of two weeks, 5 mg daily as a maintenance therapy. If the subject is tolerable, the dose can be increased as 10 mg/day as maximum dose.
16237532|NCT01104545|Drug|MK-3614|
16237533|NCT01104545|Drug|Comparator: Placebo|
16237534|NCT01104532|Drug|ASP1941|oral tablet
16237535|NCT01104532|Drug|sitagliptin|oral tablet
16237536|NCT01104519|Drug|Niaspan|Oral doses of 2000 mg of Niaspan once daily for 7 days.
16237537|NCT01104519|Drug|Comparator: Placebo|Oral doses of placebo once daily for 7 days.
16237538|NCT01104506|Procedure|fMRI|
16237539|NCT01104506|Procedure|mTMS|
16237540|NCT01104493|Biological|Monovalent Frozen FluMist®|Single dose of monovalent vaccine (240 subjects) by intranasal spray on Study Day 1.
16237541|NCT01104493|Other|Placebo|Single dose of placebo (60 subjects) by intranasal spray on Study Day 1
16237542|NCT01104480|Drug|Tocilizumab|Tocilizumab 8mg/kg every 2 weeks given by IV infusion
16237543|NCT01104467|Drug|Desmoteplase|1 bolus injection of desmoteplase 70 µg/kg intravenous (IV)
16237544|NCT01104467|Drug|Desmoteplase|1 bolus injection of desmoteplase 90 µg/kg (IV)
16237545|NCT01104467|Other|Placebo|1 bolus injection of placebo IV
16237546|NCT01104428|Drug|Placebo|granules, <10years,10g,Three times a day,take orally >10years,20g,Three times a day,take orally fore weeks a period,Observe 2 periods
16237547|NCT01104428|Drug|"ziying granules"|granules, <10years,10g,Three times a day,take orally >10years,20g,Three times a day,take orally fore weeks a period,Observe 2 periods
16237548|NCT01104415|Drug|Telotristat etiprate|Telotristat etiprate capsules orally three times daily.
16237549|NCT01104402|Device|Home lung function and symptom monitoring|subjects in the intervention arm will measure spirometry and CF symptoms with the use of a handheld device.
16237550|NCT01104389|Device|Fluorescence imaging|Intraoperatively acquire fluorescence images of renal tumors
16237701|NCT01103284|Drug|DiaPep277|1.0 mg dose in 0.5 mL of solution
16237702|NCT01103284|Drug|Placebo|"40 mg mannitol in 0.5 mL of solution.
~Dosing: 0, 1, 3, 6, 9, 12, 15, 18, 21, 24 months"
16237551|NCT01104376|Drug|Efavirenz|"In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered.
~In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily."
16237552|NCT01104376|Drug|voriconazole|"In phase 1 day 1 (control phase) a single 100mg dose of efavirenz will be administered.
~In phase 2 (voriconazole pretreatment phase), the subject will be pretreated with voriconazole (400mg twice daily on phase 2 day 8 and then 200mg twice daily for the next consecutive 8 days. In phase 3 (efavirenz plus voriconazole phase), the subject will receive on phase 3 day 10 100mg single dose of efavirenz along with 200mg of voriconazole twice daily."
16237553|NCT01104363|Procedure|Snow white plaster 2|Test. Plaster impression not splinted.
16237554|NCT01104363|Procedure|Primopattern LC gel + PVS|Control PVS impression
16237555|NCT01104350|Other|external radiation therapy with gemcitabine|"All patients will undergo daily image-guided radiation therapy with concurrent twice weekly gemcitabine chemotherapy. Radiation therapy will begin 2-4 weeks after restaging cystoscopy/fiducial marker placement.
~Dose level #1: 23.4 Gy/1.8 Gy × 13 fractions (total dose 68.4 Gy)
~Dose level #2: 27.0 Gy/1.8 Gy × 15 fractions (total dose 72.0 Gy)
~Dose level #3: 30.6 Gy/1.8 Gy × 17 fractions (total dose 75.6 Gy)"
16237556|NCT01104337|Drug|paracetamol|Treatment consisted of two paracetamol 500mg (Doliprane® 500mg, Sanofi-aventis, Paris, France) tablets twice a day along with two matching placebo tablets once daily
16237557|NCT01104337|Drug|paracetamol|Treatment consisted of two paracetamol 500mg (Doliprane® 500mg, Sanofi-aventis, Paris, France) tablets three times a day
16237558|NCT01104337|Drug|Placebo|Treatment consisted of two matching placebo tablets three times a day.
16237559|NCT01104311|Procedure|Aggressive BP lowering|adjust the amount and number of antihypertensive drugs to lowering of systolic blood pressure to target level
16237560|NCT01104311|Procedure|modest blood pressure lowering|adjust the amount and number of antihypertensive drugs
16237561|NCT01104298|Drug|Doxorubicin|A maximum of 6 cycles every 3 weeks of doxorubicin monotherapy 75 mg/square meter will be given in the absence of progression or not acceptable toxicity.
16237562|NCT01104298|Drug|Trabectedin|A maximum of 6 cycles every 3 weeks of the combination (Trabectedin 1,1 mg/square meter + doxorubicin 60 mg/square meter) will be given in the absence of progression or not acceptable toxicity.
16237563|NCT01104272|Device|LipoSonix (Ultrasound treatment of Subcutaneous Adipose Tissue)|Study of Adipose Tissue Treatment Using Focused Ultrasound
16237564|NCT01104259|Drug|veliparib|Given PO
16237565|NCT01104259|Drug|cisplatin|Given IV
16237566|NCT01104259|Drug|vinorelbine tartrate|Given IV
16237567|NCT01104259|Other|laboratory biomarker analysis|Correlative studies
16237568|NCT01104259|Other|pharmacological study|Correlative studies
16237569|NCT01104246|Drug|Testerone Transdermal System|Transdermal testosterone applied daily for 4 weeks
16237570|NCT01104233|Device|LAP Protector|The LAP Protector is a device that consists of two flexible rings made of superelasticity alloys covered with polyurethane polyamide, and a thin silicone rubber membrane that is attached to the outer rim of the two rings
16237571|NCT01104220|Other|Weight loss|Bariatric surgery-induced weight loss to achieve ~20%-30% reduction in initial body weight
16237572|NCT01104207|Device|repetitive transcranial magnetic stimulation (rTMS)|rTMS involves application of electromagnetic pulses through a coil to the subject's scalp. Some of the electromagnetic energy is transmitted to underlying neural tissue. The goal for this study: 1 Hz rTMS will suppress neural activity responsible for tinnitus perception.
16237573|NCT01104207|Device|placebo rTMS|placebo rTMS
16237574|NCT01104194|Dietary Supplement|omega-3 fatty acids supplements (fish oil)|1.74g eicosapentaenoic acid (EPA) and 0.25g docosahexaenoic acid (DHA)
16237575|NCT01104194|Dietary Supplement|Placebo|softgel capsules (identical in appearance to fish oil capsules) containing olive oil. 3 capsules/day, 4 weeks
16237576|NCT01104181|Device|HC2 collection kit with a swab or brush|We will sample the anal canal for cells with either a swab and swab or swab and brush to determine which is superior
16237577|NCT01104155|Drug|eribulin mesylate + erlotinib|21-day Regimen: Eribulin mesylate given at a dose of 2 mg/m2 as a 2-5 min intravenous (IV) bolus on Day 1 and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 2-16 of a 21-day cycle.
16237578|NCT01104155|Drug|eribulin mesylate + erlotinib|28-day Regimen: Eribulin mesylate given at a dose of 1.4 mg/m2 as a 2-5 min IV bolus on Days 1 and 8, and 150 mg of erlotinib given orally once daily, one hour before or two hours after the ingestion of food, on Days 15-28 of a 28-day cycle.
16237579|NCT01104142|Device|CGM|Continuous Glucose Monitoring System
16237580|NCT01104116|Radiation|[18F]-FDG PET/CT imaging|Drug: F-18 Fluoro-2-Deoxyglucose (F-18 FDG)
16237581|NCT01104103|Device|BOA(R)-Constricting IV Band|Device applied in accordance with manufacturer's instructions
16237582|NCT01104103|Device|Standard elastic constricting band|Standard therapy
16237583|NCT01104090|Device|C-MAC direct laryngoscopy|Patients assigned to this arm will be intubated using C-MAC with direct laryngoscopy first and later indirect laryngoscopy
16237584|NCT01104090|Device|C-MAC Indirect laryngoscopy|Patients for this arm will be intubated with C-MAC using indirect technique
16237585|NCT01104064|Device|real rTMS combined with constraint induced therapy|10 minutes of priming followed by 10 minutes of low-frequency is followed on the next day with constraint induced therapy. A total of 5 treatment days for each therapy is given.
16237586|NCT01104064|Device|sham rTMS combined with constraint induced therapy|10 minutes of sham priming followed by 10 minutes of sham low-frequency is followed on the next day with constraint induced therapy. A total of 5 treatment days for each therapy is given.
16237587|NCT01104038|Behavioral|EXCEL|Children in the EXCEL intervention will receive 12 weeks of supervised physical activity, guided by principles of behavior change, in the form of exergaming (technology-mediated interactive physical activity)3 times per week for 12 weeks and will also receive weekly group nutrition education sessions
16237588|NCT01104038|Behavioral|EXCEL|Participants in the EXCEL intervention will receive 12 weeks of supervised physical activity in the form of exergaming (technology-mediated physical activity). Sessions will be held 3 times per week with 60 minutes of supervised physical activity.
16237589|NCT01104038|Behavioral|Nutrition Education ONLY|Children in the nutrition education group will receive 30 minutes per week of group nutrition education in the school environment and delivered by a registered dietitian The nutrition education sessions will be identical to those provided for the EXCEL group.
16237590|NCT01104025|Drug|ATG, rabbit|ATG, rabbit (Thymoglobulin, Genzyme) will be dosed at 5 mg/kg/dose, given IV on 5 consecutive days (titrated over 4 to 8 hours).
16237591|NCT01104025|Drug|Etoposide|Etoposide will be dosed at 150mg/m2, given IV. The first dose will be given 7 days (+/- 2 days) after the first dose of ATG, and be given weekly for a total of 7 doses.
16237592|NCT01104025|Drug|Methotrexate|Intrathecal Methotrexate and hydrocortisone will be administered to CNS+ patients (CNS+ patients are those patients which have any of the following: elevated CSF (cerebral spinal fluid) protein or white count, seizures, focal or global neurologic deficit, MRI abnormalities consistent with CNS involvement by HLH.) in the following doses: age< 1 yr: 6/8mg (MTX/HC), 1-2 yrs: 8/10mg, 2-3 yrs: 10/12mg, >3 yrs: 12/15 mg. It will be administered (+/- 3 days) on day 7, 14, 21 and 42.
16237593|NCT01104025|Drug|hydrocortisone|Intrathecal Methotrexate and hydrocortisone will be administered to CNS+ patients (CNS+ patients are those patients which have any of the following: elevated CSF (cerebral spinal fluid) protein or white count, seizures, focal or global neurologic deficit, MRI abnormalities consistent with CNS involvement by HLH.) in the following doses: age< 1 yr: 6/8mg (MTX/HC), 1-2 yrs: 8/10mg, 2-3 yrs: 10/12mg, >3 yrs: 12/15 mg. It will be administered (+/- 3 days) on day 7, 14, 21 and 42.
16237594|NCT01104025|Drug|Dexamethasone|will be started with the ATG. It will be divided BID, given IV for at least 1 week before switching to PO. Dosing: 20mg/m2/day x7days, 10mg/m2/day x7days, 5mg/m2/day x14days, 2.5mg/m2/day x14days, 1.25mg/m2/day x14days.
16237595|NCT01104012|Biological|"Classification as asthmatic or rhinitis only via proteomic analysis"|Proteomic profiles are established for each patient using plasma and serum samples
16237596|NCT01104012|Biological|"Classification as asthmatic or rhinitis only according to a metacholine test"|A positive metacholine test indicating bronchial hyperresponsiveness is currently our Gold Standard for diagnosing asthma.
16237597|NCT01103986|Behavioral|Motivational/health literacy education (Test group)|"Attend a 1-hour class to learn how to use the book What to Do When Your Child Gets Sick."
16237598|NCT01103973|Behavioral|Mind/Body Program|Ten week group mind/body program
16237599|NCT01103973|Behavioral|Control|Spa gift certificates
16237600|NCT01103960|Drug|Telmisartan80mg+Amlodipine5mg|combination therapy
16237601|NCT01103960|Drug|amlodipine 5mg|monotherapy
16237602|NCT01103960|Drug|Telmisartan80mg+Amlodipine 5mg|combination therapy
16237603|NCT01103947|Device|EcoAnaesthesia facemask first|The trial facemask will be used before the standard one.
16237604|NCT01103947|Device|Portex Adult (Standard) facemask first|The standard facemask will be applied before the trial device.
16237605|NCT01103947|Device|Portex Adult (Standard) facemask second|The standard facemask will be applied after the trial device
16237606|NCT01103947|Device|EcoAnesthesia facemask second|The trial facemask will be used after the standard one.
16237607|NCT01103934|Drug|Vitamin D3|4000 IU once daily
16237608|NCT01103934|Drug|Placebo|Placebo taken once daily
16237609|NCT01103934|Drug|Fluticasone Propionate|200 mcg daily, intranasal
16237610|NCT01103921|Other|Glucose|25% dose at 2-week intervention assigned to subjects.
16237611|NCT01103921|Other|Fructose|25%, 17.5%, or 10% dose at 2-week intervention assigned to subjects.
16237612|NCT01103921|Other|High-Fructose Corn Syrup|25%, 17.5%, or 10% dose at 2-week intervention assigned to subjects.
16237613|NCT01103921|Other|No sugar (Aspartame)|0% dose at 2-week intervention assigned to subjects.
16237614|NCT01103908|Device|HCE101 Cardiopulmonary Support Monitor|Measurement of cardiac output using ultrasound dilution technology. The ultrasound dilution technology is in the HCE101 Cardiopulmonary Support Monitor.
16237615|NCT01103856|Behavioral|Patient Mentor Intervention|The first session includes an exploration of needs, barriers, and facilitators to HIV care. HIV educational materials are introduced to identify areas of need. Mentors will address concerns and possible barriers to care using their own experiences. Mentors will encourage participants to set goals related to acquisition of care following discharge and how to address possible barriers to that goal. The second session will reinforce the first session. Mentors will call the patient 5 times over the 10 weeks after discharge. These phone calls will be brief and goal centered, to either reinforce positive behavior if the patient is in care, or continue to help the patient re-engage in outpatient HIV care.
16237616|NCT01103856|Behavioral|HIV transmission risk reduction|The control intervention is a modification of the project RESPECT intervention. We will use material from sessions 1, 2, and 3 of the RESPECT enhanced counseling intervention. These interactions will include a personalized assessment of risk behaviors and changing condom use self-efficacy. The second interaction will build on material covered during the first interaction, with additional focus on condom use attitudes. The counselors will call the patient 5 times in the 10 weeks after discharge. These phone-based sessions will be brief and goal centered, to reinforce safe HIV transmission behaviors.
16237617|NCT01103843|Drug|Loading Dose Arm|Subjects who are thienopyridine naive will be randomized 1:1 to either clopidogrel 600 mg or prasugrel 60 mg loading dose at the time of PCI. A Verify Now P2Y12 platelet assay will measure platelet reactivity. Cross over to loading dose and maintenance dose of alternate medication will occur based on level of platelet reactivity.
16237618|NCT01103843|Drug|Maintenance Dose Arm|Verify Now P2Y12 platelet assay will measure platelet reactivity. Cross over to a loading dose and maintenance dose of alternate medication will occur based on level of platelet reactivity.
16237619|NCT01103830|Drug|Eurartesim™|3 or 4 tablets of Eurartesim™ (40mg Dihydroartemisinin and 320 mg Piperaquine phosphate), depending of body weight (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day 1 to Day 3
16237620|NCT01103830|Drug|Riamet®|4 tablets of Riamet® (20mg artemether/120mg lumefantrine) on Day -1 evening, 4 tablets of Riamet® bid (with an interval of 12 ± 0.5 h), in the morning and in the evening of Day 1 and Day 2, 4 tablets of Riamet® in the morning of Day 3.
16237621|NCT01103830|Other|Placebo and finally Moxifloxacin|"3 or 4 tablets of Eurartesim™ placebo, depending of body weight, (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day1 to Day 3.
~1 tablet of Izilox® (400 mg moxifloxacin) on Day 4 morning."
16237794|NCT01102504|Drug|Placebo|Placebo
16237622|NCT01103830|Drug|Eurartesim™|3 or 4 tablets of Eurartesim™ (40mg Dihydroartemisinin and 320 mg Piperaquine phosphate), depending of body weight (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day 1 to Day 3.
16237623|NCT01103830|Drug|Eurartesim™|3 or 4 tablets of Eurartesim™ (40mg Dihydroartemisinin and 320 mg Piperaquine phosphate), depending of body weight (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day 1 to Day 3.
16237624|NCT01103830|Other|Placebo and finally Moxifloxacin|"3 or 4 tablets of Eurartesim™ placebo, depending of body weight, (3 tablets for subjects weighting less than 75 kg, 4 tablets for subjects weighting 75 kg or more), once daily from Day1 to Day 3.
~1 tablet of Izilox® (400 mg moxifloxacin)on Day 4 morning."
16237625|NCT01103817|Dietary Supplement|Vitamin D|"Dosing If the 25 OH Vitamin D level at Baseline/Screening is less than 20 nmol/L then the subject will receive 2000 IU daily.
~If the 25 OH Vitamin D level at Baseline/Screening is between 20 and 37.5 nmol/L then the subject will receive 1000 IU daily."
16237626|NCT01103791|Drug|Docetaxel-PNP|Docetaxel-PNP, Polymeric Nanoparticle Formulation of Docetaxel
16237627|NCT01103778|Drug|Bortezomib (Velcade®)|Velcade® at 1.3 mg/m2, on days 1, 4, 8 and 11 (=1 cycle).
16237628|NCT01103765|Procedure|post dilatation after stent deployment|Post-dilatation with a noncompliant balloon larger 0.25mm than stent balloon.
16237629|NCT01103765|Procedure|stent deployment without post-dilatation|stent deployment without systematic post dilatation
16237630|NCT01103752|Other|no intervention, descriptive study|no intervention, descriptive study
16237631|NCT01103739|Drug|PF-04531083|PF-04531083: 100mg to be dosed twice daily as a suspension from Day 2 through Day 14 of the study.
16237632|NCT01103739|Drug|simvastatin|Simvastatin: a single 20mg tablet to be given on Days 1 and 14 of the study.
16237633|NCT01103739|Drug|PF-04531083|PF-04531083: a dose to be selected depending on results from Cohort 1 to be dosed twice daily as a suspension from Day 2 through Day 14 of the study.
16237634|NCT01103739|Drug|simvastatin|Simvastatin: a single 20mg tablet to be given on Days 1 and 14 of the study.
16237635|NCT01103726|Drug|PF-02545920|1 and 5 mg tablets, 6 mg single dose
16237636|NCT01103726|Drug|placebo|matching placebo tablets, single dose
16237637|NCT01103726|Drug|PF-02545920|1 mg tablets, 3 mg single dose
16237638|NCT01103726|Drug|PF-02545920|5 mg tablets, 15 mg single dose
16237639|NCT01103726|Drug|Placebo|matching placebo tablets, single dose
16237640|NCT01103713|Drug|Azithromycin plus chloroquine|Study drug is a fixed dose tablet of AZCQ containing 250 mg AZ and 155 mg CQ base. All subjects will be administered a 3 day course of AZCQ IPTp regimen: a single dose of 1000 mg AZ/620 mg CQ base (4 fixed dose combination tablets of AZCQ: 250mg/155mg) administered per os (PO, orally) once daily for 3 days (Days 0, 1, 2).
16237641|NCT01103687|Biological|Ad26.ENVA.01 (rAd26)|5 x 10^10 virus particles (VP) vaccine delivered intramuscularly (IM)
16237642|NCT01103687|Biological|Placebo Vaccine|Placebo vaccine delivered IM
16237643|NCT01103674|Device|Numeris®-AF Guided Coagulation System with VisiTrax®|Combined epicardial / endocardial procedure using the Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the Biosense Webster ThermoCool Catheter in conjunction with the Carto Navigation System endocardially.
16237644|NCT01103661|Device|Numeris®-AF Guided Coagulation System with VisiTrax®|Combined epicardial / endocardial procedure using the nContact Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the St. Jude Medical Therapy™ Cool Path™ Ablation Catheter endocardially.
16237645|NCT01103648|Drug|Simvastatin|Tablets of simvastatin 20 mg administered once a day for 12 weeks
16237646|NCT01103648|Drug|Ezetimibe|Tablets of ezetimibe 10 mg administered once a day for 12 weeks
16237647|NCT01103648|Drug|Combination Simvastatin plus Ezetimibe|"Simvastatin 20 mg, once a day, was administered for an additional 12-week period for the subset of individuals who took the initial monotherapy with ezetimibe 10 mg (12 week duration).
~Ezetimibe 10 mg, once a day, was administered for an additional 12-week period for the subset of individuals who took the initial monotherapy with simvastatin 20 mg (12 week duration).
~This Combination represents the experimental period of the present study."
16237648|NCT01103635|Biological|CD40 agonist monoclonal antibody CP-870,893|Given IV
16237649|NCT01103635|Biological|tremelimumab|Given IV
16237650|NCT01103635|Other|laboratory biomarker analysis|Correlative studies
16237651|NCT01103622|Drug|AZD1656|Oral tablet bd, step-wise increased dosage
16237652|NCT01103622|Drug|Digoxin|Oral tablet od on Day 4
16237653|NCT01103622|Drug|Placebo|Oral tablet bd, step-wise increased dosage
16237654|NCT01103609|Drug|Warfarin|Oral tablet od on Day 4
16237655|NCT01103609|Drug|Placebo|Oral tablet bd, stepwise increased
16237656|NCT01103609|Drug|AZD1656|Oral tablet bd, stepwise increased
16237657|NCT01103583|Drug|Hydroxyurea|500 mg/die per os for two years
16237658|NCT01103583|Other|placebo|500 mg/die per os for two years
16237659|NCT01103570|Procedure|cholecystocholangiography|a central venous pressure catheter was introduced through the anterior abdominal wall subcostally in a direction parallel to the gallbladder bed under direct vision so that it emerges close to the gall bladder. Then the catheter was advanced into the fundus of the gall bladder . The dye was prepared by diluting 20ml of 76% urografin with 20ml normal saline in a 50ml syringe
16237660|NCT01103570|Procedure|cystic duct cholangiography|Then a 14G cannula was introduced through the anterior abdominal wall subcostally, (size 4F), was introduced through this cannula. The catheter was inserted into the cystic duct no more than 1 cm, by a grasper Then a 50ml syringe with the diluted urografin dye, as above, was attached to the catheter and cholangiography was performed by slowly injecting the dye under control of C-arm image intensifier.
16237661|NCT01103557|Procedure|prophylactic selective lateral neck dissection|Level II, III, IV lymph node dissection
16237662|NCT01103531|Behavioral|Aerobic and Resistance Exercise|Aerobic and resistance exercise for 24 exercise training sessions over an 8-week period (three times weekly).
16237663|NCT01103531|Behavioral|Educational information about health topics|A counselor will meet with participants for 24 sessions (3 times/week) over an 8-week period to present and discuss information that includes topics on health and wellness, and lifestyle topics such as healthy eating, meditation, sleep hygiene, and cancer screening.
16237795|NCT01102504|Dietary Supplement|Ateronon|Tomato extract containing 28 mg lycopene/ day
16237664|NCT01103518|Drug|Ethinyl Estradiol + Cyproterone acetate|Ethinyl Estradiol (0.035mg) + Cyproterone acetate (2mg), coated tablets. Each treatment cycle consists of one tablet, once per day for 21 days followed by a 7-day rest period. A total of 4 treatment cycles will be completed during the study treatment period.
16237665|NCT01103505|Diagnostic Test|ForeseeHome AMD Monitoring Device|Earlier detection of progression from intermediate dry age-related macular degeneration to CNV between routine eye exams through home diagnostic testing with the ForeseeHome AMD Monitoring device
16237666|NCT01103492|Device|HALO90 Ablation catheter|FDA approved endoscopic device for use in coagulation of tissue in the digestive tract using radiofrequency energy.
16237667|NCT01103479|Behavioral|Physician Intervention|Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training
16237668|NCT01103479|Behavioral|Physician and Patient Intervention|Physicians at these clinics will participate in 6 training sessions over the course of 3 1/2 years; training sessions relate to colorectal cancer (CRC) screening guidelines, communication skills, and health literacy training; patients in this condition will also view an educational DVD on CRC and CRC screening
16237669|NCT01103466|Device|Atlas|Altas base plates are tested for 14 days (minimum 4 base plates) and the degree of leakage under the baseplate is measured and compared to two other types of base plates.
16237670|NCT01103466|Device|SenSura|SenSura base plates are tested for 14 days (minimum 4 base plates) and the degree of leakage under the baseplate is measured and compared to two other types of base plates.
16237671|NCT01103466|Device|Conform 2|Conform 2 base plates are tested for 14 days (minimum 4 base plates) and the degree of leakage under the baseplate is measured and compared to two other types of base plates.
16237672|NCT01103453|Behavioral|Virtual Action Planning Supermarket (VAP-S) Software|"The VAP-S simulates a supermarket with multiple aisles displaying items. Several obstacles are designed to hinder the progression of the shopper along the aisles. In addition, virtual humans populate the supermarket. The VAP-S is designed so that the user enters the supermarket behind the cart and navigates within the supermarket via the keyboard keys. He is thus able to experience the environment personally without any intermediate. The task is to purchase 7 items from a list, proceed to the cashier and pay for them.
~We propose 9 sessions of 45 minutes. The results will be analyzed to develop goals for intervention, together with the client to study his awareness of his performance of IADL and Executive functions and to enhance his motivation to participate in the intervention."
16237673|NCT01103440|Drug|Intravenous Glycoprotein inhibitor + ASA, Clopidogrel|IV Glycoprotein IIb/IIIa inhibitor bolus intra procedurally
16237674|NCT01103440|Drug|Antiplatelet Therapy (ASA, Clopidogrel)|Standard antiplatelet PCI treatment
16237675|NCT01103427|Device|Internet-based behavioral coaching|"Those in the active comparator arm will benefit from automated coaching by e-mails with advice, information and support for smoking cessation. These e-mails will be adapted to their personal profile."
16237676|NCT01103427|Device|SMS based coaching|Those in the experimental SMS based coaching arm will benefit from automated coaching by SMS with advice, information and support for smoking cessation. These SMS's will be adapted to their personal profile.
16237677|NCT01103427|Device|SMS coaching - UNN recruited|Those in the experimental SMS based coaching arm- UNN recruited - will benefit from automated coaching by SMS with advice, information and support for smoking cessation. These SMS's will be adapted to their personal profile.
16237678|NCT01103427|Device|SMS craving function - UNN recruited|Those in the experimental SMS based craving/panic function arm - will in addition to the automated coaching by SMS have a panic/craving SMS function. Thus by sending a SMS they will receive instant advise and support for smoking cessation by SMS.
16237679|NCT01103414|Drug|Mitoglitazone|50 mg capsules, once daily for 84 days
16237680|NCT01103414|Drug|Mitoglitazone|Mitoglitazone 100 mg capsules, once daily for 84 days
16237681|NCT01103414|Drug|Mitoglitazone|Mitoglitazone 150 mg capsules, once daily for 84 days
16237682|NCT01103414|Drug|Pioglitazone|Pioglitazone 45 mg, once daily for 84 days
16237683|NCT01103414|Drug|Placebo|Placebo, once daily for 84 days
16237684|NCT01103401|Drug|Drug: Tobramycin 0.3% - Dexamethasone 0.1%|one drop four times per day
16237685|NCT01103401|Drug|Drug: Tobramycin-Dexamethasone plus Ketorolac tromethamine|Tobramycin-Dexamethasone one drop four times per day and Ketorolac tromethamine one drop three times per day
16237686|NCT01103388|Drug|Rituximab|375 mg/m^2 by vein (IV) in 4 weekly doses (1 cycle) every 6 months for 4 cycles.
16237687|NCT01103375|Drug|erlotinib hydrochloride|Given PO
16237688|NCT01103375|Drug|isotretinoin|Given PO
16237689|NCT01103375|Other|laboratory biomarker analysis|Correlative study
16237690|NCT01103375|Genetic|protein expression analysis|Correlative study
16237691|NCT01103362|Drug|flibanserin|all patients will receive open-label flibanserin 100mg
16237692|NCT01103349|Drug|BI671800|Double blind randomised parallel group study to assess efficacy and tolerability of BI617800 in patients with symptomatic asthma
16237693|NCT01103349|Drug|Placebo|Patients receive placebo capsules and/or encapsulated tablets
16237694|NCT01103349|Drug|Montelukast|Double blind randomised parallel group study to assess efficacy and tolerability of BI671800 in patients with symptomatic asthma
16237695|NCT01103336|Drug|pretreatment with intravenous nicorandil vs. placebo before coronary angiography|"Nicorandil group: Pretreatment with intravenous Nicorandil (Sigmart for injection, Choongwae Pharma, Seoul) 12 mg in 0.9% saline 100 ml over 2 hours starting from 1 hour prior to coronary angiography
~Control group: Pretreatment with intravenous 0.9% saline 100 ml over 2 hours starting from 1 hour prior to coronary angiography"
16237696|NCT01103323|Drug|Regorafenib (Stivarga, BAY73-4506)|160 mg per oral once daily for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off)
16237697|NCT01103323|Drug|Placebo|matching placebo tablets for 3 weeks of every 4 week cycle (i.e., 3 weeks on, 1 week off)
16237698|NCT01103323|Other|Best Supportive Care (BSC)|BSC includes any concomitant medications or treatments: antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any other symptomatic therapy necessary to provide BSC, except other investigational anti-tumor agents or anti-neoplastic chemo/hormonal/immuno-therapy.
16237699|NCT01103310|Drug|BAY94-9392|
16237703|NCT01103271|Other|Open-label Placebo|Participants take open-label placebo pills - two twice daily for four weeks.
16237704|NCT01103258|Procedure|high ligation and stripping (surgery)|surgery consisting of high ligation in combination with long saphenous stripping
16237705|NCT01103258|Procedure|FOAM|duplex guided foam sclerotherapy
16237706|NCT01103245|Drug|Hydrochlorothiazide (HCTZ)|HCTZ 12.5mg daily
16237707|NCT01103245|Drug|Aliskiren 150 mg (ALI 150)|Aliskiren 150mg daily
16237708|NCT01103245|Drug|Spironolactone (SPL 25)|spironolactone 25mg daily
16237709|NCT01103245|Drug|Aliskiren 300 mg (ALI 300)|Aliskiren 300mg daily
16237710|NCT01103245|Drug|Spironolactone 50 mg (SPL 50)|Spironolactone 50 mg daily
16237711|NCT01103232|Procedure|Experimental group|Electrical muscle stimulation (EMS) of the right wrist flexor muscles was applied. EMS was applied for 20 minutes. Maximum current intensity tolerated was used so as to stimulate the highest possible number of motor unit. The stimulation intensity increased every five minutes during a session. Electrical stimulation was applied for thirty sessions (one session a day, five days a week for six weeks.)
16237712|NCT01103232|Procedure|Control group|Conventional mode of transcutaneous electrical nerve stimulation (TENS) was applied for the control subjects. TENS was applied for 20 minutes. The stimulus intensity was adjusted as the lowest current at which the subject felt only a slight tickling of the impulses. A visible, and palpable muscle contraction was not provided during TENS stimulation. The stimulus intensity was not changed during the first session. Subsequently, TENS was applied at same intensity in all sessions. TENS was applied for thirty sessions (one session a day, five days a week for six weeks).
16237713|NCT01103219|Dietary Supplement|Nutrition|The control (placebo) group will be fed according to the routines of the participating institutions. The intervention (active) group will receive increased supply of energy, protein, vitamin A and long-chain unsaturated fatty acids.
16237714|NCT01103206|Drug|cinacalcet|Intake of a single tablet of cinacalcet
16237715|NCT01103206|Drug|cinacalcet dose 1|PTH suppression test in primary hyperparathyroidism using cinacalcet (dose 1).
16237716|NCT01103206|Drug|cinacalcet dose 2|Parathyroid hormone suppression test in primary hyperparathyroidism using cinacalcet (dose 2).
16237717|NCT01103193|Drug|remifentanil injected|mixture of 60% nitrous oxide and 40% oxygen is administered through a face mask. In the first group the patient receives a constant concentration of sevoflurane. In this group the remifentanil concentration will be injected via an intravenous line in a step up protocol.
16237718|NCT01103193|Drug|sevoflurane in step up concentration|of 60% nitrous oxide and 40% oxygen is administered through a face mask.remifentanil is injected in a fixed rate and sevoflurane is administered in a step up concentration.
16237719|NCT01103180|Drug|Escitalopram|10-20 mg of escitalopram daily for eight weeks (10mg for the first 2 weeks, 20mg thereafter)
16237720|NCT01103167|Behavioral|control of ultrafiltration|During the interventional period, dry weight of patients will be adjusted according to the results of body composition.
16237721|NCT01103154|Drug|carvedilol|6.25mg per day, increase to 6.25mg bid
16237722|NCT01103154|Drug|nadolol + ISMN|nadolol 40-80mg ISMN 10-20mg
16237723|NCT01103141|Device|Micropuncture needle set|Groin access for vascular intervention
16237724|NCT01103141|Device|Standard gauge-18 needle set|Groin access for vascular intervention
16237725|NCT01103115|Dietary Supplement|Calcium 600mg plus Vit D 400 IU|Daily supplementation with 600mg Calcium plus 400IU Vitamin D3
16237726|NCT01103115|Dietary Supplement|Calcium 600mg plus Vit D 800 IU|Daily supplementation with 600mg Calcium plus 800IU Vitamin D3
16237727|NCT01103115|Dietary Supplement|Placebo|placebo tablets
16237728|NCT01103102|Drug|Iocide Oral Rinse|Oral Rinse; dosages vary by treatment group; once to twice daily use (depending on treatment group); 12 weeks duration
16237729|NCT01103102|Drug|Placebo|Placebo
16237730|NCT01103076|Device|Polyamide HD membrane|Single use polyamide membrane
16237731|NCT01103063|Drug|Azithromycin plus chloroquine|combination tablet of 250mg azithromycin/155 chloroquine, Once daily PO for three days per treatment. There are total 3 treatments at 4-8 weeks intervals. The first treatment course will be administered during the second trimester (14-26 weeks of gestation as confirmed by ultrasound). The last treatment course should be given to subjects prior to or during 36 weeks of gestation.
16237732|NCT01103063|Drug|sulfadoxine-pyrimethamine|Fansidar tablet (500 mg sulfadoxine /25 mg pyrimethamine), once daily, PO, single dose per treatment. There are total 3 treatments at 4-8 weeks intervals. The first treatment course will be administered during the second trimester (14-26 weeks of gestation as confirmed by ultrasound). The last treatment course should be given to subjects prior to or during 36 weeks of gestation.
16237733|NCT01103050|Drug|QAV680 + Cetirizine Placebo|
16237734|NCT01103050|Drug|QAV680 + Cetirizine|
16237735|NCT01103050|Drug|Cetirizine + QAV680 Placebo|
16237736|NCT01103050|Drug|QAV680 Placebo + Cetirizine Placebo|
16237737|NCT01103037|Drug|QAV680|QAV680 500 mg (5 x 100 mg capsules) four times per day
16237738|NCT01103037|Drug|QAV680 Placebo|Placebo to QAV680 5 capsules four times per day
16237739|NCT01103024|Biological|AIN457|
16237740|NCT01103024|Biological|AIN457|
16237741|NCT01103024|Biological|AIN457|
16237742|NCT01103024|Biological|Placebo|
16237743|NCT01103011|Drug|ND0611|Continuous delivery of ND0611
16237744|NCT01103011|Drug|ND0611|Solution of ND0611 delivered continuously
16237745|NCT01102985|Behavioral|aerobic resistance exercise|three times per week aerobic resistance exercise for 12 months
16237746|NCT01102985|Behavioral|home based health promotion|education and support to adapt national guidelines for 30 minutes physical activity most days of the week
16237747|NCT01102972|Drug|Reyataz + Norvir + Truvada|atazanavir 300mg + ritonavir 100mg + tenofovir 300mg/emtricitabine 200mg
16237748|NCT01102972|Drug|Reyataz + Epzicom|atazanavir 400mg + abacavir 600mg/lamivudine 300mg
16237749|NCT01102959|Device|Photographic Educational Material|Photographic Educational Material on Carbohydrate Counting
16237750|NCT01102946|Drug|Ranibizumab|Ranibizumab (Lucentis), intravitreal injections of 0.05ml
16237751|NCT01102946|Procedure|Panretinal Photocoagulation|Panretinal photocoagulation with green laser according to ETDRS
16237796|NCT01102491|Drug|Ramosetron|ramosetron intravenous injection, 0.3mg, 1 time/day for 2 days
16237752|NCT01102920|Behavioral|Behavioural strategies to promote physical activity and weight loss|"8-10 sessions, 2-4 booster sessions Behavioural protocol in seven steps to initiate, carry out and maintain health-enhancing physical activity and sound eating habits.
~Steps are standardized including: progressive goal setting, self-monitoring, functional behavioural analysis, skills training (basic and applied), generalization, and maintenance and relapse prevention. Content within each step is tailored to individual expectations and skills.
~Treatments are provided by a physical therapist and a dietician."
16237753|NCT01102920|Device|CPAP|CPAP-treatment as usual (during nights)
16237754|NCT01102907|Other|Liquid Breakfast|The liquid breakfast meal will contain 370 calories and will consist of fruit juices and skim milk
16237755|NCT01102907|Other|Solid Breakfast Meal|The solid breakfast will contain 370 calories and will consist of oatmeal, golden delicious apples, blueberries, skim milk, and brown sugar.
16237756|NCT01102894|Device|SmartPill|SmartPill
16237757|NCT01102881|Dietary Supplement|Glucose polymer fiber|20 grams of fiber per day split into two 10 gram doses administered as a breakfast cereal and a muffin or no-fiber breakfast cereal and muffin
16237758|NCT01102881|Dietary Supplement|Fiber made from corn starch|20 grams of fiber per day split into two 10 gram doses administered as a breakfast cereal and a muffin or no-fiber breakfast cereal and muffin
16237759|NCT01102881|Dietary Supplement|placebo|low fiber breakfast cereal and muffin
16237760|NCT01102868|Device|Needle in acupuncture point Li11|Acupuncture needle in acupuncture point Li11
16237761|NCT01102868|Device|IMS of the musculus pronator teres|Acupuncture needle in musculus pronator teres
16237762|NCT01102816|Other|Individualized acupuncture treatment|"Individualized acupuncture treatment which focuses on each patient's symptoms and conditions will be provided twice a week for 6 weeks on a non-dialysis access day or before hemodialysis at dialysis-access day. 10-20 acupuncture needles will be inserted on the body except the arteriovenous fistula-located arm(s). Electrical stimulation of acupuncture will be conducted on 4 needles and the remained needles will be manipulated manually to elicit de-qi sensation. Needle retention time will be 20 minutes.
~Routine care provided by dialysis staffs, primary physicians and other healthcare providers will be maintained.
~Patients who received acupuncture treatment will be interviewed to explore patient's perceptions and experiences of acupuncture for their pain management. (Nested-qualitative study)"
16237763|NCT01102816|Other|Routine care|Patients in this group will maintain routine care provided by their dialysis staffs, primary physicians or other healthcare providers for symptomatic care and disease management of end-stage renal disease through 6 weeks. After post-treatment evaluation, acupuncture treatment will be provided to patients who want to receive acupuncture treatment.
16237764|NCT01102803|Behavioral|Individual Cognitive Behavioral Therapy (CBT)|The aim of CBT is to help participants become more comfortable with heights situations. Participants will receive 2 sessions over two weeks of individual CBT.
16237765|NCT01102803|Drug|D-Cycloserine|D-Cycloserine
16237766|NCT01102803|Drug|Placebo|Sugar Pill
16237767|NCT01102777|Behavioral|automated internet-mediated walking program|intervention participants are encouraged to walk daily to their step-count goal while wearing a pedometer provided by the study that will measure their daily step-counts. They are also encouraged to log into their personally tailored website to upload their step counts and obtain other information about the study and progress
16237768|NCT01102777|Other|Usual Care|Control group, instructed to wear the pedometer but not provided with walking goals or instruction.
16237769|NCT01102764|Behavioral|Telemedicine|Prolonged Exposure (PE) therapy provided at patients house via telemedicine
16237770|NCT01102764|Behavioral|In Person|PE therapy delivered in person at the VAMC
16237771|NCT01102712|Device|BTVA System|Unilateral Bronchoscopic Thermal Vapor Ablation for Lung Volume Reduction
16237772|NCT01102699|Drug|Filgrastim, hrG-CSF|Single subcutaneous injection of Filgrastim (hrG-CSF) 300 microg (30 MU)
16237773|NCT01102686|Drug|Pyrimethamine|Pyrimethamine will be taken orally as a single daily dose of 25 mg/day for 4 weeks, then increasing by 25 mg per dose in three four-week steps, to a final dose of 100 mg/day
16237774|NCT01102686|Drug|Leucovorin|To eliminate or minimize potential hematologic effects of Pyrimethamine, Leucovorin is to be co-administered with Pyrimethamine at a dose level of 5 mg per day, given when Pyrimethamine is administered.
16237775|NCT01102673|Drug|PF-04991532|The tentative dosing schedule is 30, 100, 300, 600, 1200, and 2000 mg. Doses shown may be adjusted upwards or downwards and may be adjusted to include intermediate doses. All doses will be administered as extemporaneously-prepared powder in capsule (PIC) formulation.
16237776|NCT01102673|Drug|Placebo|Placebo to match PF-04991532 will be provided
16237777|NCT01102660|Drug|PH-797804|Tablet, 6 mg once daily for 2 weeks
16237778|NCT01102660|Drug|Placebo|Tablet, 0 mg once daily for 2 weeks
16237779|NCT01102660|Drug|Placebo|Tablet, 0 mg once daily for 2 weeks
16237780|NCT01102660|Drug|PH-797804|Tablet, 6 mg once daily for 2 weeks
16237781|NCT01102660|Drug|Naproxen|Tablet, 500 mg twice daily for 2 weeks
16237782|NCT01102660|Drug|Naproxen + PH-797804|Tablet, 500 mg twice daily for 2 weeks and Tablet, 6 mg once daily for 2 weeks
16237783|NCT01102660|Drug|Naproxen + PH-797804|Tablet, 500 mg twice daily for 2 weeks and Tablet, 6 mg once daily for 2 weeks
16237784|NCT01102660|Drug|Naproxen|Tablet, 500 mg twice daily for 2 weeks
16237785|NCT01102647|Dietary Supplement|phytosterol ester|1.6 g phytosterols/day for 29 days
16237786|NCT01102634|Device|Transcutaneous electrical nerve stimulation (TENS)|Application of TENS over acupuncture points
16237787|NCT01102634|Device|Transcutaneous electrical nerve stimulation (TENS)|Placebo
16237788|NCT01102608|Drug|Ifosfamide|3 cycles of Ifosfamide (12g/m2) associated to Mesna (6g/m2), in i.v infusion 6 days, every 3 weeks
16237789|NCT01102595|Drug|Temozolomide|"Temozolomide 85 mg/m2/d x 21 days every 28 days for 2 cycles.
~Temozolomide 75 mg/m2/d x 42-49 days
~Temozolomide 150 - 200 mg/m2 d1-d5 q 28d for 6 cycles."
16237790|NCT01102595|Drug|Bevacizumab|"2 cycles + bevacizumab 10 mg/kg every 15 days each two cycles.
~Bevacizumab 10 mg/kg every 15 days, three dosis."
16237791|NCT01102595|Radiation|Standard radiation therapy|42-49 days with standard radiation therapy (60 Gy): 2 Gy per day.
16237792|NCT01102517|Procedure|video-assisted thoracoscopic surgery|video-assisted thoracoscopic surgery
16237793|NCT01102517|Procedure|axillary thoracotomy|axillary thoracotomy lobectomy
16237798|NCT01102465|Drug|losartan potassium hydrochlorothiazide|100 mg / 25 mg tablet
16237799|NCT01102452|Dietary Supplement|Commercially Available Wet Noodle|Commercially Available Wet Noodle will be served as a diet equivalent to daily energy needs as judged by indirect calorimetry and of same macronutrient composition.
16237800|NCT01102452|Dietary Supplement|PPB-R-203-02 Noodle|PPB-R-203-02 Noodle is manufacture by Pharma Power Biotec Co., Ltd. The composition of PPB-R-203-02 Noodle is resistant starch (RS). By definition, resistant starch (RS) is any starch that is not digested in the small intestine but passes to the large intestine (or the colon). Therefore, resistant starch can be regarded as a component of dietary fiber. PPB-R-203-02 Noodle will be served as a diet equivalent to daily energy needs as judged by indirect calorimetry and of the same macronutrient composition.
16237801|NCT01102439|Drug|Clopidogrel|300 mg loading dose, then 75 mg daily
16237802|NCT01102439|Drug|Clopidogrel|600 mg loading dose, 150 mg daily day 2-7, then 75 mg daily
16237803|NCT01102439|Drug|Aspirin|81 mg daily
16237804|NCT01102439|Drug|Aspirin|325 mg daily
16237805|NCT01102426|Drug|Plitidepsin|plitidepsin: powder and solvent for concentrate for solution for infusion. 2 mg vial + 4 ml ampoule. 5 mg/m2 intravenously (i.v.) over three hours on Day 1 and 15 every 4 weeks. dexamethasone: 4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks at least one hour before plitidepsin infusion.
16237806|NCT01102426|Drug|Dexamethasone|4 mg tablet. 40 mg orally on Day 1, 8, 15 and 22 every four weeks.
16237807|NCT01102413|Drug|Monofer|Infusion or injections
16237808|NCT01102413|Drug|Iron Sulphate|Oral intake
16237809|NCT01102400|Drug|MEDI-575|MEDI-575 will be administered weekly or every 3 weeks as IV infusion as part of a 21-day treatment cycle. One or two doses will be selected for expansion part
16237810|NCT01102387|Drug|LAS41003|Once daily, topically
16237811|NCT01102387|Drug|LAS189962|Once daily, topically
16237812|NCT01102387|Drug|LAS189961|Once daily, topically
16237813|NCT01102374|Drug|High Dose Vitamin D|Vitamin D3 100,000 IU monthly
16237814|NCT01102374|Drug|Standard Dose Vitamin D|Vitamin D 12,000 IU monthly
16237815|NCT01102374|Drug|Placebo|Placebo monthly
16237816|NCT01102374|Dietary Supplement|Usual Care|Usual care of 0-1000 IU vitamin D daily. This is present in both study arms.
16237817|NCT01102361|Procedure|Robotic Transperineal Biopsy|Saturation biopsy for previous negative patients
16237818|NCT01102348|Other|PEP-uP Protocol|Protocol documents (i.e. pre-printed order, algorithm for advancing feed, and algorithm for calculating rate of administering feed as per 24hour volume) and a slide presentation coupled with educational reminders (posters and bedside notices) and practice helps (tool to remind nurse to measure and report nutritional adequacy) were made available to all nurses, in bedside manuals and on the local intranet
16237819|NCT01102335|Procedure|Transcatheter arterial chemoembolization (TACE)|The procedure is performed under local anaesthesia. The femoral artery at groin region is punctured for arterial access. Angiography is performed for demonstration of vascular structures before embolization.The arteries supplying the tumor are selectively catheterized, this includes the hepatic arteries or other extrahepatic collateral arteries.The chemotherapeutic agent(s) is mixed with lipiodol (an oily contrast) to enhance tumour uptake. Following delivery of the lipiodol/chemotherapy mixture, small gelfoam particles may be injected to reinforce the effect of treatment.
16237820|NCT01102335|Drug|Telbivudine|anti-HBV drug
16237821|NCT01102322|Behavioral|Quality|Factors associated with the use of lung protective ventilation strategy (LPV) in ALI/ARDS patients in ICU
16237822|NCT01102309|Device|Robot therapy (NeReBot)|Rehabilitation therapy of the affected arm with NeRebot for five weeks, five times weekly for 40 minutes, plus 80 minutes of conventional therapy
16237823|NCT01102309|Other|Conventional therapy|Conventional rehabilitation therapy of the affected arm for five weeks, five times weekly for 120 minutes
16237824|NCT01102296|Biological|Hepatitis A vaccine|2 or 3 doses of hepatitis A vaccine to HIV-infected male homosexuals and 2 doses of hepatitis A vaccine to HIV-uninfected male homosexuals.
16237825|NCT01102283|Device|Evolution(R) Colonic Stent|Palliative treatment of colonic obstruction or strictures caused by malignant neoplasms and to relieve acute large bowel obstruction prior to colectomy in patients with malignant strictures.
16237826|NCT01102270|Drug|Eszopiclone|3mg tablet once prior to sleep
16237827|NCT01102270|Drug|Placebo|1 placebo capsule prior to sleep
16237828|NCT01102257|Drug|Omega-3 EFA Supplement|"The total daily dose from the 5 capsules in treatment group will be 3.0 grams of omega-3 EFAs comprised of:
~2000 mg EPA 1000 mg DHA"
16237829|NCT01102257|Drug|Olive Oil|Placebo group will take 5 capsules a day containing 3.0 grams of olive oil
16237830|NCT01102244|Drug|Tobradex ST|tobramycin / dexamethasone ophthalmic suspension 0.3%/0.05% 1 drop 4 times daily for 14 days
16237831|NCT01102244|Drug|Azasite|azithromycin 1% 1 drop twice daily for 2 days, then once daily for 12 days
16237832|NCT01102231|Drug|Chemotherapy|Pemetrexed 500 mg/m², D1 (D1=D22, 4 cycles) Cisplatin 75 mg/m², D1 (D1=D22, 4 cycles)
16237833|NCT01102231|Drug|ERBITUX|The initial dose of cetuximab (ERBITUX) is 400 mg/m² intravenously administered over 120 minutes, followed by 11 weekly infusions at 250 mg/m² IV over 60 minutes
16237834|NCT01102231|Radiation|Radiotherapy|66 Gy (2 Gy by fraction, 5 fractions by week)
16237835|NCT01102218|Drug|Erythropoietin|Standard of Care
16237836|NCT01102218|Drug|Erythropoietin|Standard of Care
16237837|NCT01102218|Drug|Pentoxifylline|400 mg qd po for 6 months
16237838|NCT01102166|Other|Acapella with nebulization|"st Phase In this phase the jet nebulizer was connected to the branch end of the Acapella according to manufacturer's recommendations.
~The volunteer did the radio-aerosol inhalation to obtain images of the lung fields scintigraphy static during the period of 300 seconds using an array of at 256x256x16 incidence later, as that encompasses most incidence of lung volume.
~nd Phase The experimental procedure of this phase was similar to the 1st stage, but what differed was it made an adjustment by placing a pipe T between the mouthpiece and the device Acapella so that the aerosol would be inhaled not pass through the device.
~Stage 3 This stage was considered phase control since the aerosol inhalation was performed through the mouthpiece connected directly to the nebulizer as is routinely used in clinical practice as illustrated. The procedure of this phase followed the same protocol of previous phases."
16237839|NCT01102153|Device|Coolgard|invasive cooling via femoral ICY-catheter
16237840|NCT01102153|Device|ArcticSun|non-invasive surface cooling by saline-cooled thermo-vest
16237841|NCT01102140|Drug|POMx, pomegranate polyphenol extract|1000 mg orally once daily.
16237842|NCT01102140|Drug|Sugar Pill|Matching sugar pill
16237843|NCT01102127|Device|Elastography|Performance of US, elastography and FNA.
16237844|NCT01102114|Biological|NicVAX Vaccine|NicVAX vaccine given 6 times over 6 months
16237845|NCT01102114|Biological|Placebo Vaccine|Placebo vaccine given 6 times over 6 months
16237846|NCT01102101|Drug|Remifentanil|Remifentanil (Ultiva; Glaxo-Smith-Kline; Vienna, Austria) will be applied intravenously during 60 minutes through a dedicated infusion pump (TCI Alaris PK Syringe Pump, Cardinal Health, Baesweiler, Germany), with a Target Controlled Infusion (following the integrated software algorithm by Minto), reaching the initial 18ng/ml plasma concentration in 180 seconds. This corresponds to approx. 0.7 µg kg-1 min-1.
16237847|NCT01102088|Radiation|Radiation Therapy|"Simultaneous integrated boost (SIB) used in combination with a fixed dose of radiation (180 cGy in 28 fractions = 5040 Gy PTV dose). Two dose levels (210 cGy and 225 cGy each in 28 fractions) of SIB will be considered in the phase I part of the study, starting at 210 cGy in 28 daily fractions.
~For the phase II part of the study once the MTD has been achieved proton therapy will be allowed. Treatment dose will be identical to that of the photon treatment where the PTV is treated to 50.4 Gy(RBE) (RBE=1.1) while the CTV is boosted to 63 Gy(RBE) in 28 fractions."
16237848|NCT01102075|Device|Electroacupuncture|We used Electrical stimulator(STN-111,Stratek)with a frequency of 24 Hz and intensity of 0.27-1.3mA(tolerable strength), asymmetric interactive pulse with continuous stimulation by the pulse generator. The participants were given treatment twice a week for 30 minutes for 5 weeks(10 sessions) by practitioner.(n=13)
16237849|NCT01102075|Device|Sham electroacupuncture procedure|We used same electroacupuncture device, number and type of needle, duration, frequency of sessions and practitioner as for the EA treatment. Specific details are as described in the arm description.(n=13)
16237850|NCT01102062|Dietary Supplement|orange juice|
16237851|NCT01102049|Dietary Supplement|fish, beef, fruit|
16237852|NCT01102036|Other|Cultura L casei F19, acidophilus La5 , B lactis Bb 12|2 weeks consumption,250 ml/day
16237853|NCT01102036|Other|Yoghurt without probiotics|Yoghurt without probiotics
16237854|NCT01102023|Other|ordinary salt based- diet|
16237855|NCT01102010|Biological|Blood transfusion|An expanded indication for blood transfusion in the frail elderly
16237856|NCT01101997|Device|The Zeltiq System|Noninvasive cooling is applied to the treatment area with a defined cooling rate and duration.
16237857|NCT01101984|Drug|diquafosol ophthalmic solution|DE-089 topical ocular application, 6 times daily for 4 weeks.
16237858|NCT01101984|Drug|0.1% sodium hyaluronate ophthalmic solution.|0.1% HA topical ocular application, 6 times daily for 4 weeks.
16237859|NCT01101971|Other|Pelvic exam video tutorial|Bryden Magee (Meds 2010) and Dr. Robert Reid created an educational DVD © 2009 that outlines a step-by-step approach to the pelvic exam; utilizing real patient video clips and illustrations. Endorsed by the Association of Professors of Obstetrics and Gynaecology of Canada (APOG), this innovation has been shown to improve both knowledge and confidence in medical students learning these skills (Magee 2009). The video content has been posted on the Queen's streaming server and incorporated into a MEdTech community accessible to all Queen's faculty and students affiliated with the School of Medicine (in MEdTech Central see OBGYN Pelvic Exam Module under community courses).
16237860|NCT01101958|Device|Chartis System|The Chartis System provides a value that represents the quantification of the average resistance to airflow through collateral airways.
16237861|NCT01101958|Device|Endobronchial Valve (EBV) Treatment|The endobronchial valve is designed to induce target lobe volume reduction.
16237862|NCT01101945|Drug|dutogliptin|400 mg QD
16237863|NCT01101932|Drug|PF-04308515|PF-04308515 will be provided as an oral solution administered at doses of 3, 10, 30 and 100 mg. If an optional cohort is needed the dose would not exceed the established toxicokinetic exposure limits. Solution will be administered orally once daily for 14 days.
16237864|NCT01101932|Drug|Placebo|Placebo solution will be administered to those volunteers who are randomized to the placebo arm. Placebo solution will be administered orally once daily for 14 days.
16237865|NCT01101932|Drug|PF-04308515 Tablet|Tablet formulation to administer a 20 mg dose will be administered to volunteers in Part 2. The study medication will be administered orally once daily for 1 day.
16237866|NCT01101919|Drug|CP-690,550|Days 1 and 6 dose of 10 mg once daily Days 2-5 doses of 10 mg twice daily
16237867|NCT01101906|Drug|OSI-906|OSI-906 administered orally
16237868|NCT01101906|Drug|Placebo|Matching placebo administered orally
16237869|NCT01101893|Drug|Raltegravir|raltegravir 400mg q12h x 5 days (Reference Treatment)
16237870|NCT01101893|Drug|GSK2248761|GSK2248761 200mg q24h x 5 days (Reference Treatment)
16237871|NCT01101893|Drug|GSK2248761 + Raltegravir|GSK2248761 200mg q24h + raltegravir 400mg q12h x 5 days (Test Treatment)
16237872|NCT01101880|Biological|filgrastim|Given SC
16237873|NCT01101880|Drug|clofarabine|Given IV
16237874|NCT01101880|Drug|cytarabine|Given IV
16237875|NCT01101867|Drug|Aspart fixed dose|fixed dose
16237876|NCT01101867|Drug|Aspart flexible dose|dose based upon carbohydrate intake and total daily requirements
16237877|NCT01101841|Drug|Brisdelle (paroxetine mesylate)|Eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo capsules in a 1:1 ratio.
16237878|NCT01101841|Drug|Placebo capsules|Eligible subjects will be randomized to receive either Brisdelle (paroxetine mesylate) Capsules 7.5 mg or placebo capsules in a 1:1 ratio.
16237879|NCT01101815|Drug|Oral Naltrexone|50 mg/day-oral
16237880|NCT01101815|Drug|Naltrexone Implant|monthly-implant
16237881|NCT01101815|Behavioral|Group Drug Counseling Manual Driven|Given to both groups biweekly, weeks 2 - 48. Counseling will consist of three components: 1) giving advice, support and clinical management aimed to maintain abstinence; 2) adherence enhancement to encourage keeping appointments, taking ART medications as prescribed and getting treatment for associated problems; and 3) reviewing behaviors that are likely to spread HIV and other infectious diseases, and counseling on how to stop them.
16237882|NCT01101802|Drug|Mycophenolate mofetil|Arm 1 patients were given 1 gm bd mycophenolate mofetil for 8 weeks, The mycophenolate was dispensed as 500mg tablets.
16237883|NCT01101802|Drug|sugar pill|Arm 2 patients were given 2 sugar pills bd for 8 weeks
16237884|NCT01101789|Procedure|triclosan coated suture for surgical wound closure|triclosan coated suture for surgical wound closure
16237885|NCT01101789|Procedure|regular sutures for surgical wound closure|
16237886|NCT01101776|Drug|Interferon beta-1a (Rebif)|Interferon beta-1a 44 micrograms (12 MIU) given three times per week (tiw) by subcutaneous injection (SCI). Dose to be reduced to 22 micrograms (6 MIU) tiw by SCI for subjects who cannot tolerate the higher dose.
16237887|NCT01101750|Biological|Quadrivalent HPV for types 6, 11, 16 and 18|"Per standard of care, Gardasil 0.5ml IM injection on day one, month 2, and month 6.
~Serum samples on day one, month 3 and month 7."
16237888|NCT01101737|Other|Nurse-led blood pressure clinic|Blood pressure will be measured according to protocol.For patients with blood pressure above optimal targets, treatment changes will be discussed with the patient, a visiting consultant physician and the patient's GP. If they agree, the GP will intensify anti-hypertensive treatment with monthly follow up by the specialist nurse until BP targets are achieved.
16237889|NCT01101724|Behavioral|Mandated Rest, Intervention|"In addition to CDC based discharge instructions, the intervention group will receive instructions with strict activity restriction explicitly stating No return to school and No Physical Activity for the next five days. Patients and parents in the intervention group will be provided school and work excuses for the five days post-injury."
16237890|NCT01101698|Drug|Vitamin K2+10μg cholecalciferol|Pills of: 90 μg vitamin K2+10μg cholecalciferol once daily during 9 months
16237891|NCT01101698|Drug|Vitamin D|Pills of: 10μg cholecalciferol (Vitamin D)once daily during 9 months
16237892|NCT01101685|Drug|Escitalopram|7 days dosing of 10mg per day
16237893|NCT01101685|Drug|Placebo|7 days dosing at 10mg daily
16237894|NCT01101672|Procedure|Single port laparoscopic colectomy|Patients will be operated by using the technique of single port laparoscopic colectomy by surgeon with experiences and training in this procedure. Laparoscopic instruments will be inserted to perform the procedure through a multi-channel single port which is placed via transumbilical incision. The same transumbilical incision will be extended to 3-4cm for extraction of specimen.
16237895|NCT01101672|Procedure|Conventional laparoscopic colectomy|Patient will be operated by techniques of conventional laparoscopic colectomy. A 10mm subumbilical incision is made for camera port, another 2-4 small incisions (5-10mm in size) will be made for placement of ports and insertion of laparoscopic instrument. A 3-4cm abdominal incision will be made for extraction of specimen.
16237896|NCT01101659|Drug|JNJ-40411813|500 mg as 20 mL of oral suspension
16237897|NCT01101659|Drug|normal saline|single dose
16237898|NCT01101659|Drug|ketamine|20 mL of oral suspension
16237899|NCT01101659|Drug|Placebo|single dose
16237900|NCT01101646|Drug|rabeprazole sodium|four 2.5 mg capsules of the phase 3 pediatric bead formulation suspended in a strawberry flavored vehicle (taken in fasted or fed state)
16237901|NCT01101646|Drug|rabeprazole sodium|two 5-mg sachets of the phase 1 pediatric bead formulation suspended in a strawberry flavored vehicle (taken in fasted state)
16237902|NCT01101646|Drug|rabeprazole sodium|four 2.5 mg capsules of the phase 3 formulation sprinkled on 1 ounce of plain yogurt
16237903|NCT01101633|Dietary Supplement|Alginate|a 500 ml alginate beverage per meal test
16237904|NCT01101633|Dietary Supplement|Alginate|a 330 ml alginate beverage per meal test
16237905|NCT01101633|Dietary Supplement|Placebo|a 500 ml placebo beverage per meal test
16237906|NCT01101633|Dietary Supplement|Placebo|a 330 ml placebo beverage per meal test
16237907|NCT01101620|Drug|Levosimendan|
16237908|NCT01101607|Procedure|Distal Forearm Fracture Reduction|Fracture reduction
16237909|NCT01101594|Drug|hLL1-DOX (the doxorubicin conjugate of milatuzumab)|hLL1-DOX will be administered intravenously (through a vein) on days 1, 4, 8 & 11 every 21 days for up to 8 treatment cycles. 4 different dose levels of hLL1-DOX will be studied for safety and tolerability.
16237910|NCT01101581|Drug|Veltuzumab and 90Y-Epratuzumab Tetraxetan|Veltuzumab will be administered subcutaneously in phase 2. 90Y-Epratuzumab tetraxetan will be administered intravenously. Veltuzumab is given once weekly for 4 weeks. 90Y-Epratuzumab is also given at treatment weeks 2 & 3 (days 8 & 15).
16237911|NCT01101581|Drug|90Y-epratuzumab tetraxetan|
16237912|NCT01101581|Drug|veltuzumab|Veltuzumab will be administered subcutaneously on days 1, 8, 15 and 23
16237913|NCT01101568|Drug|Simvastatin|Simvastatin 40mg (single dose) on Days 1 and 10.
16237914|NCT01101568|Drug|Rosuvastatin|Rosuvastatin 10mg (single dose) on Days 3 and 12.
16237915|NCT01101568|Drug|GSK1292263|GSK1292263 300mg BID Days 6 to 14.
16237916|NCT01101555|Drug|subcutanious administration|drug will be administered subcutaneously in varying amounts over a verying time period according to details stated in the 'arms' section
16237917|NCT01101555|Other|Placebo|Placebo will be given to one member of each cohort.
16237918|NCT01101542|Biological|Cervarix.|Subjects will receive three doses of the Cervarix vaccine administered intramuscularly according to a 0, 1, 6 month vaccination schedule in routine clinical practice settings.
16237919|NCT01101542|Other|Data collection|All adverse events will be recorded by all subjects or the subject's parents/guardians using diary cards.
16237920|NCT01101529|Drug|Aprepitant (Emend)|Aprepitant will be added to the standard anti-emetic therapy. Emend is given orally, 125 mg the first day, then 80 mg daily during the chemotherapy course and 7 days after
16237921|NCT01101529|Drug|Placebo|Placebo will be administered instead of Emend
16237922|NCT01101503|Drug|Intensive multifactorial group|"Intensive multifactorial therapy and conventional multifactorial therapy will be taken for 1 year, and then take them together, and give same treatment for 10 years.
~The intensive multifactorial therapy group:
~For blood glucose control, target HbA1c >=5.5%and <=6.0%,fasting blood glucose >=5.0 mmol/L and <=6.0 mmol/L, postprandial 2 hour glucose >= 6.0 mmol/L and <= 7.8 mmol/L. The drugs include insulin, oral hypoglycemic agents.
~For blood lipids control, target LDL-C < =1.9 mmol/L, triglyceride < =1.5 mmol/L. The drugs include statin and fibrate.
~For blood pressure control, target >=120/70 mmHg and <= 130/80 mmHg. The drugs include ACE inhibitor, angiotensin II-receptor antagonist, diuretic, beta-blocker and calcium-channel blocker.
~Others, such as aspirin."
16237963|NCT01101191|Drug|Reformulated OXY (oxycodone HCl)|Reformulated OXY 80-mg tablet x 1 dose taken without food.
16238096|NCT01100177|Radiation|Radiation|Radiation therapy (60Gy) 2 Gy per day during 30 days
16237923|NCT01101503|Drug|conventional multifactorial therapy group|"Intensive multifactorial therapy and conventional multifactorial therapy will be taken for 1 year, and then take them together, and give same treatment for 10 years.
~The conventional multifactorial therapy group:
~For blood glucose control, target HbA1c >6.5%and <=7.0%,fasting blood glucose >6.0 mmol/L and <=7.0 mmol/L, postprandial 2 hour glucose > 7.8 mmol/L and <= 10.0 mmol/L. The drugs include insulin, oral hypoglycemic agents.
~For blood lipids control, target LDL-C > 1.9 mmol/L and < =2.5 mmol/L, triglyceride > 1.5 mmol/L and < = 2.5 mmol/L. The drugs include statin and fibrate.
~For blood pressure control, target >130/80 mmHg and <= 140/90 mmHg. The drugs include ACE inhibitor, angiotensin II-receptor antagonist, diuretic, beta-blocker and calcium-channel blocker.
~Others, such as aspirin."
16237924|NCT01101477|Procedure|TCI titration by different Cet.|"Induction:
~After topical xylocaine and alfentanil 5μg/kg iv 1 minute before, Cet 2.0μg/ml is started on the TCI pump ('Vial Injectomat TIVA Agilia syringe infusion pump, Fresenius Kabi, France). The sedative level will be accessed by sedation scale OAA/S every 30 seconds till OAA/S ≦3(Responds only to name called loudly). The current Ce will be set as the maintenance Cet.
~If desired OAA/S is not achieved after reaching 2.0μg/ml,Cet will be increased every 90 seconds by the regimens be assigned until OAA/S ≦3. The current Ce will be set as the maintenance Cet.
~Maintenance:
~The Cet will be increased according to the assigned regimens if:
~Patients become irritant and interfere procedures.
~Patients open eyes or talk to express uncomfortable.
~The Cet will be decreased if:
~Systolic blood pressure is less than 90mmHg;
~Mean arterial blood pressure is less than 65mmHg;
~Oxyhemoglobin saturation is less than 90 %
~with any duration."
16237925|NCT01101464|Drug|Asenapine 3x5mg followed by 1x15mg|Three 5 mg sublingual tablets (15 mg) given twice daily for 2 days followed by one 15 mg sublingual tablet given twice daily for 1.5 days
16237926|NCT01101464|Drug|Asenapine 1x15mg followed by 3x5mg|One 15 mg sublingual tablet given twice daily for 2 days followed by three 5 mg sublingual tablets (15 mg) given twice daily for 1.5 days.
16237927|NCT01101451|Drug|Cisplatin|Given IV
16237928|NCT01101451|Radiation|External Beam Radiation Therapy|Undergo radiotherapy
16237929|NCT01101451|Radiation|Intensity-Modulated Radiation Therapy|Undergo radiotherapy
16237930|NCT01101451|Other|Laboratory Biomarker Analysis|Correlative studies
16237931|NCT01101451|Other|Quality-of-Life Assessment|Ancillary studies
16237932|NCT01101451|Other|Questionnaire Administration|Ancillary studies
16237933|NCT01101438|Drug|metformin hydrochloride|Given orally
16237934|NCT01101438|Other|placebo|Given orally
16237935|NCT01101412|Drug|Edetate Calcium Disodium|Given through CVC or PVC.
16237936|NCT01101412|Drug|Ethanol|Given through CVC or PVC
16237937|NCT01101412|Drug|Trimethoprim-sulfamethoxazole|Given through CVC or PVC
16237938|NCT01101412|Other|Hypertonic Saline|Given through CVC or PVC
16237939|NCT01101399|Drug|Ferric carboxymaltose|"Subjects will receive a single dose of 1,000 mg iron as FCM infusion at baseline.
~Subjects of bw ≤66 kg will receive a single dose of 500 mg iron as FCM infusion at baseline (Week 0) and at Visit 4 (Week 2).
~Ferric carboxymaltose will be administered on the same day with chemotherapy treatment or within 24 hours before or after the chemotherapy. For subjects with bw ≤66 kg, if no chemotherapy planned for the visit 4 (Week 2), the second FCM dose should be infused independent of chemotherapy."
16237940|NCT01101386|Drug|Voriconazole|Patients will be started on voriconazole 6 mg/kg IV q12h on day 1, then 4 mg/kg IV q12h thereafter.
16237941|NCT01101360|Device|Matrix RF|Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week)
16237942|NCT01101360|Device|Matrix RF followed by Pulse Dye Laser|Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week)
16237943|NCT01101360|Device|Pulse Dye Laser followed by Matrix RF|Section of port wine stain to be treated 5 times every 5 weeks (+/- 1 week)
16237944|NCT01101347|Device|Aneurysm-Embolization System|
16237945|NCT01101334|Drug|CS-7017|CS-7017, Two 0.25mg Tablets administered twice daily
16237946|NCT01101334|Drug|erlotinib|Erlotinib; One 150mg tablet administered once daily
16237947|NCT01101321|Drug|Reformulated OXY (Totowa) (oxycodone HCl)|Reformulated OXY 80-mg tablet (Totowa) x 1 dose taken without food.
16237948|NCT01101321|Drug|Reformulated OXY (Wilson) (oxycodone HCl)|Reformulated OXY 80-mg tablet (Wilson) x 1 dose taken without food.
16237949|NCT01101308|Drug|Reformulated OXY (Totowa) (oxycodone HCl)|Reformulated OXY 10-mg tablet (Totowa) x 1 dose taken in the fasted state.
16237950|NCT01101308|Drug|Reformulated OXY (Wilson) (oxycodone HCl)|Reformulated OXY 10-mg tablet (Wilson) x 1 dose taken in the fasted state.
16237951|NCT01101282|Device|Positive expiratory pressure (PEP) mask therapy|PEP mask therapy will be performed once/day, supervised, by an experienced physiotherapist until hospital discharge or ≥ 24 hours without sputum expectoration (whichever comes first). Written instructions shall also be provided, encouraging two more independent PEP mask sessions per day. Each session will comprise up to 5 cycles of 8-10 slightly active breaths, followed by 2 huffs (FET) and 2 coughs. A target pressure of 10-20 cms H20 during the middle of expiration shall be used (monitored via a pressure manometer).
16237952|NCT01101269|Drug|ACEI or ARB|Subjects will be asked to discontinue their usual ACE inhibitor or Angiotensin Receptor Blocker (ARB) for ten days, undergo a CEU using Definity (for renal blood flow assessment) as the contrast agent, then resume their usual ACEI or ARB for ten days, then undergo another CEU using Definity as the contrast agent.
16237953|NCT01101269|Drug|Lisinopril|Subjects will be undergo a CEU using Definity (for renal blood flow assessment) as the contrast agent, then take Lisinopril 10 mg every day for 7 days, after which they will undergo another CEU using Definity as the contrast agent.
16237954|NCT01101243|Radiation|Broadband UVB|UVB dose: 1 SED every week
16237955|NCT01101243|Radiation|Broadband UVB|UVB dose: 4 SED every second week
16237956|NCT01101243|Radiation|Broadband UVB|UVB dose: 1 SED every second week
16237957|NCT01101243|Radiation|Broadband UVB|UVB dose: 1 SED every month
16237958|NCT01101243|Other|Control group|No intervention
16237959|NCT01101230|Other|Almonds|1.5 oz almonds/day
16237960|NCT01101217|Drug|Zinc Supplement|in 50 patients zinc sulfate 220 mg per day orally for 6 weeks
16237961|NCT01101217|Drug|placebo|placebo daily for 6 weeks
16237962|NCT01101204|Drug|Metformin 1000mg, simvastatin 10mg and fenofibrate 100mg|Patient will take three pill consisting of metformin 1000mg, simvastatin 10mg and fenofibrate 100mg.
16237964|NCT01101191|Drug|Original OxyContin® (OXY) (oxycodone HCl)|Original OxyContin® (OXY) 80-mg tablet x 1 dose taken without food.
16237965|NCT01101178|Drug|Reformulated OXY (oxycodone HCl)|Reformulated OXY 80-mg tablet x 1 dose taken with food.
16237966|NCT01101178|Drug|Original OxyContin® (OXY) (oxycodone HCl)|Original OxyContin® (OXY) 80-mg tablet x 1 dose taken with food.
16237967|NCT01101165|Drug|Reformulated OXY (oxycodone HCl)|Reformulated OXY 40-mg tablet x 1 dose taken without food
16237968|NCT01101165|Drug|Original OxyContin® (OXY) (oxycodone HCl)|Original OxyContin® (OXY) 40-mg tablet x 1 dose taken without food
16237969|NCT01101152|Drug|Desvenlafaxine succinate|"Tablets of 50 mg,100 mg; Dosing regimen: 50, 100, 200 mg/day; 1 week for each dose regimen;
~1 tablet a day for doses of 50 and 100mg/day, and 2 tablets of 100mg for dose of 200mg/day"
16237970|NCT01101139|Drug|Sugammadex|Sugammadex (single intravenous injection 0.25 mg/kg)
16237971|NCT01101139|Drug|Placebo|Placebo: single intravenous injection Saline 0.9%
16237972|NCT01101126|Other|Pulmonary disease management|Comprehensive pulmonary care including patient education of self-care, coordination of care, monitoring of patient adherence, providing advice in acute exacerbations
16237973|NCT01101126|Other|Usual care|Pulmonary disease is managed by the primary practitioner and a consultant pulmonologist
16237974|NCT01101113|Drug|cinacalcet|cinacalcet 25mg qd or 50 mg qd
16237975|NCT01101113|Drug|control|vit D + P binder
16237976|NCT01101100|Drug|AMG 827|210 mg SC or 140 mg SC
16237977|NCT01101087|Device|Taurolock|
16237978|NCT01101087|Other|Placebo|Injectable sodium chloride conditioned in exactly the same manner as the experimental product.
16237979|NCT01101074|Other|This is non-intervention observational study|This is non-intervention observational study
16237980|NCT01101061|Drug|Romosozumab|Administered by subcutaneous injection
16237981|NCT01101061|Drug|Placebo|Administered by subcutaneous injection
16237982|NCT01101048|Drug|Placebo|Subjects will be randomized to receive one of 3 doses of AMG 167 or equivalent volume of placebo administered at once every two-week or once every four-week dosing intervals. Postmenopausal women will receive AMG 167 in one of 3 fixed doses, while men will receive AMG 167 in one of 2 fixed doses by injection under the skin.
16237983|NCT01101048|Drug|AMG 167|Subjects will be randomized to receive one of 3 doses of AMG 167 or equivalent volume of placebo administered at once every two-week or once every four-week dosing intervals. Postmenopausal women will receive AMG 167 in one of 3 fixed doses, while men will receive AMG 167 in one of 2 fixed doses by injection under the skin.
16237984|NCT01101035|Drug|Febuxostat|Febuxostat tablets
16237985|NCT01101035|Drug|Allopurinol|Allopurinol tablets
16237986|NCT01101022|Drug|SPD489|1 capsule per day (30, 50 or 70 mg), daily throughout the double-blind treatment period (10 weeks)
16237987|NCT01101022|Other|Placebo|1 capsule per day, daily throughout the double-blind treatment period (10 weeks)
16237988|NCT01101009|Drug|Perindopril + amlodipine + if necessary, hydrochlorothiazide|Two perindopril 4 mg tablets + 1 amlodipine 10 mg tablet + placebo tablet matching the olmesartan/amlodipine tablet. All tablets are taken once daily. The duration of administration of perindopril tablets and placebo is 24 weeks. The duration of administration of amlodipine tablets is 24-26 weeks. Hydrochlorthiazide tablets 12.5 mg or 25 mg, once daily, will be added, if necessary
16237989|NCT01101009|Drug|olmesartan/amlodipine + hydrochlorothiazide, if necessary.|olmesartan/amlodipine tablets 40 mg/10 mg, + placebo tablets matching the perindopril tablet and amlodipine tablet. All tablets are taken once daily for 24 weeks. Hydrochlorthiazide tablets 12.5 mg or 25 mg, once daily, will be added, if necessary
16237990|NCT01100996|Other|control enteral nutrition|This feeding consists of 20en% fat, 16en% protein and 49en% carbohydrates
16237991|NCT01100996|Other|enriched enteral feeding|This feeding contains 46 energy percent (en%) fat, 24en% protein and 30en% carbohydrates and is enriched with phospholipids.
16237992|NCT01100957|Procedure|tracheal intubation with a single use flexible videoscope|tracheal intubation with a single use flexible videoscope
16237993|NCT01100944|Drug|PXD101with cisplatin+doxorubicin+cyclophosphamide|PXD101 will be given as a 48h continuous intravenous infusion (CIVI) starting on day 1, doxorubicin as a slow intravenous (IV) injection on days 2 and 3, cisplatin will be infused over 1 hour on day 2 and cyclophosphamide as a slow IV infusion on Day 3. Treatment will be given every 21 days for no more than 6 cycles or until disease progression. Treatment with PXD101 alone may continue until disease progression.
16237994|NCT01100931|Drug|YM155|"Phase I: Doses were given at different dose levels until the maximum tolerated dose (MTD) was reached. Dose level 1: 3.6 mg/m^2, dose level 2:5 mg/m^2 , dose level 3:6 mg/m^2, dose level 4:8 mg/m^2, dose level 5:10 mg/m^2 (MTD), dose level 6:12 mg/m^2. Doses were given by continuous intravenous infusion over 72 hours every 21 days.Three patients were enrolled at each dose level in the absence of dose limiting toxicity (DLT). A DLT is defined as adverse events occurring during the first cycle of therapy (e.g. every 21 days).
~Phase II: 10 mg/m^2 (MTD)intravenous infusion over 72 hours every 21 days."
16237995|NCT01100931|Drug|Carboplatin|Area under curve (AUC) of 6 intravenous on day 1
16237996|NCT01100931|Drug|Paclitaxel|200 mg/m^2 intravenous on day 1
16237997|NCT01100918|Device|BiV ICD|Biventricular ICD
16237998|NCT01100918|Device|ICD|Implantable Defibrillator
16237999|NCT01100905|Other|Iron-containing food product|
16238000|NCT01100892|Drug|Once-daily insulin detemir|Insulin detemir is a long-acting insulin analog. Starting dose 0.1 units/kg/day (titrated according to the results of home blood glucose monitoring).
16238001|NCT01100879|Drug|Ferric carboxymaltose|"Subjects will receive a single dose of 1,000 mg iron as FCM infusion at baseline.
~Subjects of bw ≤66 kg will receive a single dose of 500 mg iron as FCM infusion at baseline (Week 0) and at Visit 3 (Week 2).
~Ferric carboxymaltose will be administered on the same day with chemotherapy treatment or within 24 hours before or after the chemotherapy. For subjects with bw ≤66 kg, if no chemotherapy planned for the visit 4 (Week 2), the second FCM dose should be infused independent of chemotherapy."
16238002|NCT01100866|Dietary Supplement|POMELLA™ (pomegranate extract)|in a capsule form, 2 x 500mg once daily
16238003|NCT01100866|Other|Placebo|placebo capsules
16238004|NCT01100853|Drug|VIVITROL injection and VIVITROL Placebo Injection , 24 weeks|Efficacy of 24 week course of VIVITROL with counseling as compared to 24 week course of VIVITROL placebo with counseling (monthly injections)
16238005|NCT01100827|Other|EGFR mutation status in patients|
16238008|NCT01100788|Dietary Supplement|Short chain fructo-oligosaccharide (scFOS) 5 g|"Dietary Supplement: scFOS 5 g
~Novel fiber administered in two 5 g doses--the first in a beverage and the second in a solid chew."
16238009|NCT01100788|Other|Placebo|Treatment without scFOS fiber
16238010|NCT01100788|Dietary Supplement|Short chain fructooligosaccharide (scFOS) 8 g|Novel fiber administered in two 8 g doses--the first in a beverage and the second in a solid chew.
16238011|NCT01100775|Drug|Galantamine|A lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing.
16238012|NCT01100775|Drug|Placebo|Subjects will be randomly assigned to the two possible order of administration: the drug and then placebo, or the placebo and then drug. Subjects will be given a lead-in 3 days of 4mg/ twice a day of galantamine (or placebo) followed by 8 mg (or placebo) on the 4th day, the day of testing.
16238013|NCT01100762|Device|Cranial Electric Stimulation (CES)|We will follow the procedure described by several investigators as safe and effective. The participant will sit on a standard chair. Two commercially available surface electrodes will be embedded in an elastic head cup. Each electrode will be covered with a water soaked absorbent fabric. One positive (+) electrode will be placed over the primary motor cortex (M1) and pre-motor areas. One negative (-) electrode will be placed over the skin overlying the contra lateral supra-orbital region. The electrodes will be connected via 2 leads to a battery powered direct current stimulator. The stimulator will be programmed to deliver 0.975mA (peak 4mA) over 20 minutes.
16238014|NCT01100762|Device|Treadmill|The participant will walk on a treadmill for 20 minutes at the individually self-selected velocity determined at baseline.
16238015|NCT01100762|Device|CES and Treadmill|Participants will have a combined session with CES while walking on the treadmill for 20 minutes at the individually self-selected velocity determined at baseline.
16238016|NCT01100736|Drug|Bosentan|Bosentan 125mg tablets, orally, twice daily for 7 days
16238017|NCT01100736|Drug|Sitaxsentan|Sitaxsentan 100mg tablets, orally, once daily for 7 days
16238018|NCT01100736|Drug|Placebo|Placebo tablets taken twice daily, orally, for 7 days (placebo arm) or once daily for 7 days (sitaxsentan arm)
16238019|NCT01100736|Biological|Endothelin-3|5 minute local intra-arterial infusion of endothelin-3 at a rate of rate of 60 pmol/min, during forearm blood flow studies
16238020|NCT01100723|Other|Cinacalcet, active vitamin D analogue|Patients will have their mineral and bone disorders managed by the computer directed algorithm. Cinacalcet will be dose increased starting at 30 mg/day as indicated by protocol along with active vitamin D based on values of serum calcium, phosphorus and parathyroid hormone.
16238021|NCT01100684|Drug|Asimadoline|0.5 mg Asimadoline BID
16238022|NCT01100684|Drug|Placebo|Placebo
16238023|NCT01100671|Other|Cross section study|This is not intervention study. The purpose of the study is to examine the relationship of vascular inflammation assessed by 18FDG-PET and MDCT at the cross section setting
16238024|NCT01100658|Drug|Methylphenidate|1 capsule each day for 1 week, .3 mg/kg dose.
16238025|NCT01100658|Drug|Placebo|1 capsule per day for 1 week.
16238026|NCT01100645|Drug|Sominex|Passiflora incarnata L.50 mg Valeriana officinalis L.40 mg Crataegus oxyacantha L.30 mg
16238027|NCT01100645|Drug|Placebo|Excipient
16238028|NCT01100632|Dietary Supplement|Ginseng, vitamins, minerals|2 capsules per day
16238029|NCT01100632|Other|Placebo - Gelatin capsule|2 capsules per day
16238030|NCT01100619|Drug|rosiglitazone|one 4 mg dose as a tablet followed by a second 4 mg dose 3 weeks later
16238031|NCT01100619|Drug|XL184|dosed with capsules daily
16238032|NCT01100606|Drug|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple juice, will be given orally daily using a syringe nurser at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period. Total dose will not exceed 10,000 lipase units per kilogram (kg) of body weight per day.
16238033|NCT01100606|Drug|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) from open capsule, mixed with a small amount of apple sauce, will be given orally daily using a spoon at dose increments of 3,000 lipase units, for 10 days in either first treatment period or second treatment period. Total dose will not exceed 10,000 lipase units per kg of body weight per day.
16238034|NCT01100593|Procedure|length of IV catheter|Subjects will be randomized to one of two IV catheter lengths
16238035|NCT01100580|Dietary Supplement|low salt diet|Daily salt intake less than 4 g/day
16238036|NCT01100580|Dietary Supplement|water therapy|abundant intake of water with a low mineral and low sodium content (at least 2 litres in winter and 3 in summer).
16238037|NCT01100567|Device|Low-magnitude mechanical stimulation platform|Low-magnitude mechanical stimulation platform
16238038|NCT01100554|Device|Sleep endoscopy|Conscious sedation will be done under intravenous propofol infusion. The sedative level would be monitored and adjusted accord to the Bispectral Index monitor. After the adequate sedative level is achieved, a bronchoscopy (Olympus, BF) was inserted from the right nostril. The velopharynx, oropharynx, larynx, and hypopharynx obstructions were evaluated.
16238039|NCT01100541|Device|Polymeric plate|Application of the polymeric plate in the shoulder for 20 minutes after warming it for 15 minutes in hot water, initially at boiling temperature.
16238040|NCT01100528|Biological|recombinant interferon alfa-2b|Given subcutaneously (SC) 3 times a week for 24 weeks
16238041|NCT01100528|Drug|dacarbazine|Given IV on days 1 and 29
16238042|NCT01100528|Other|laboratory biomarker analysis|Correlative studies obtained prior to therapy, every 8 weeks while on therapy, and then every 6 months during follow-up
16238043|NCT01100515|Other|normobaric oxygen therapy|oxygen therapy was delivered via a full face mask at high flow to achieve 100% of inspired oxygen fraction
16238044|NCT01100515|Other|Hyperbaric oxygen therapy|Hyperbaric oxygen therapy was delivered in a hyperbaric chamber, pressurized at 2 absolute atmosphere (1 hour plateau) and the patient breathed high oxygen concentration via a full face mask followed by 4 hours of normobaric oxygen therapy
16238045|NCT01100502|Drug|brentuximab vedotin|Every 21 days by IV infusion (1.8 mg/kg)
16238046|NCT01100502|Drug|placebo|Every 21 days by IV infusion
16238047|NCT01100489|Radiation|external beam radiation therapy|External beam breast radiation therapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.
16238048|NCT01100489|Other|questionnaire administration|Ancillary studies: The patient will complete the Cosmesis /QOL form (Appendix II) and the treating physician will complete the Cosmetic Guidelines (skin assessment) form for baseline data (Appendix I).
16238049|NCT01100489|Procedure|therapeutic conventional surgery|Patients will undergo excisional biopsy or needle localization removal of the tumor. Patients with margins < 2 mm undergo re-excision of the biopsy cavity. Surgical clips should be placed at the time of tylectomy to define the excision cavities. Ideally, clips are to be placed marking the superficial, deep, right, left, inferior, and superior dimensions of the tylectomy or re-excision cavities.
16238050|NCT01100476|Device|Endovascular Diagnostic Procedures|Patients underwent a percutaneous diagnostic procedure utilizing a 5F procedural sheath in the common femoral artery
16238051|NCT01100463|Drug|Cream|Twice daily lotion to prevent HFS
16238052|NCT01100463|Drug|0.1% Uracil Cream|Twice daily lotion to prevent HFS
16238053|NCT01100450|Behavioral|Progressive Resistance Training|12-week progressive resistance training (PRT) exercise program
16238054|NCT01100437|Drug|EMBEDA™ (morphine sulfate/naltrexone hydrochloride) crush|Placebo capsules plus EMBEDA capsules crushed and mixed in solution administered orally at each patient's stable dose, given either once daily or twice daily
16238055|NCT01100437|Drug|EMBEDA™ (morphine sulfate/naltrexone hydrochloride) whole|EMBEDA capsules, administered orally and intact at each patient's stable dose, given either once daily or twice daily with 150mL placebo solution
16238056|NCT01100424|Device|Opti-Free RepleniSH|Commercially available contact lens solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.
16238057|NCT01100424|Device|ReNu MultiPlus|Commercially available contact lens solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.
16238058|NCT01100424|Device|Balafilcon A|Commercially available silicone hydrogel contact lenses removed from blister pack and soaked overnight in Opti-Free Replenish, ReNu MultiPlus, or Unisol 4, then applied to the eye and worn for 2 hours.
16238059|NCT01100424|Other|Unisol 4|Commercially available non preserved sterile saline solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.
16238060|NCT01100411|Device|Air Optix Aqua|Contact lens material: Lotrafilcon A
16238061|NCT01100411|Device|Biofinity|Contact lens material: Comfilcon A
16238062|NCT01100411|Device|Proclear|Contact lens material: Omafilcon A
16238063|NCT01100411|Device|Acuvue Oasys|Contact lens material: Senofilcon A
16238064|NCT01100411|Device|Acuvue 2|Contact lens material: Etafilcon A
16238065|NCT01100411|Device|Purevision|Contact lens material: Balafilcon A
16238066|NCT01100398|Procedure|possible liver biopsy and serum collection|All patients with a positive ultrasound for hepatic steatosis offered a liver biopsy after obtaining fasting blood work that included a complete blood count, coagulation studies, liver function tests, fasting lipid panel, glucose and insulin. Patients with a negative ultrasound for fatty liver are not referred for liver biopsy and are considered as completed study patients. Serum is also stored for adipokine and cytokine analysis. A study investigator using a 14g Bard Monopty biopsy gun performs the liver biopsy.
16238067|NCT01100385|Dietary Supplement|Ateronon|Tomato extract (lycopene) capsule, taken once daily for 56 days
16238068|NCT01100385|Dietary Supplement|Placebo|Matched placebo capsule, taken once daily for 56 days
16238069|NCT01100372|Drug|gemcitabine hydrochloride|
16238070|NCT01100372|Drug|liposome-encapsulated doxorubicin citrate|
16238071|NCT01100372|Procedure|quality-of-life assessment|
16238072|NCT01100359|Drug|carboplatin|
16238073|NCT01100359|Drug|liposome-encapsulated doxorubicin citrate|
16238074|NCT01100359|Other|laboratory biomarker analysis|
16238075|NCT01100359|Procedure|quality-of-life assessment|
16238076|NCT01100346|Drug|Gonal-f (Follitropin alpha)|A starting dose of 75 IU/day subcutaneously is maintained for a period of 7 to 14 days. The follitropin alpha dose would be subsequently increased by 37.5 IU/day at weekly intervals based on the ovarian response.
16238077|NCT01100333|Drug|Recombinant human follicle stimulating hormone (r-hFSH)|Recombinant hFSH prescribed according to prescriber's judgement
16238078|NCT01100320|Drug|Reformulated OXY (oxycodone HCl)|Reformulated OXY 40-mg tablet x 1 dose taken with food
16238079|NCT01100320|Drug|Original OxyContin® (OXY) (oxycodone HCl)|Original OxyContin® (OXY) 40-mg tablet x 1 dose taken with food
16238080|NCT01100307|Drug|pegaptanib sodium|Intravitreal injection of 0.3 mg every 6 weeks
16238081|NCT01100307|Other|sham injection|sham injection every 6 weeks
16238082|NCT01100294|Biological|Vaccination with FLUVAL P|"Vaccination with Fluval P monovalent influenza vaccine with 6 μg HA/0.5 ml active ingredient content and aluminium phosphate gel adjuvant.
~Dose: 0.25 ml (total 3 μg HA), single dose."
16238083|NCT01100281|Behavioral|Neuropsychological examination|Examination including especially concept formation
16238084|NCT01100281|Other|MRI|MRI performed in T1-weighted three dimensional sequence
16238085|NCT01100268|Drug|Methylphenidate ER|Subjects will start at 18mg/day; the dose will be increased in increments of 18mg per week to reach 72mg/day.
16238086|NCT01100255|Drug|Ketamine infusion|0.5mg/kg IV over 40 minutes
16238087|NCT01100255|Other|Saline|saline infusion
16238088|NCT01100242|Drug|Velcade and Sorafenib|Velcade will be administered intravenously; sorafenib will be self-administered on an outpatient basis. At least 2 courses will be administered to each patient unless there is early progression of disease or unacceptable toxicity. Repeated courses may be given to patients who benefit from the treatment (complete or partial remission or stabilization of disease)
16238089|NCT01100216|Other|Nicotine Lozenge|4 mg for 12 days
16238090|NCT01100216|Other|Stonewall Dissolvable Tobacco Pieces|5.6 mg nicotine pieces for 12 days
16238091|NCT01100216|Other|Camel Snus Frost|pouches, 6.2 mg nicotine, for 12 days
16238092|NCT01100216|Other|Skoal Wintergreen|Used at baseline (Days 1 and 2, 5-11) and then at every 7 day wash-out period.
16238093|NCT01100203|Drug|Eplerenone|25 mg once daily 1 week, then 50 mg once daily for another 23 weeks.
16238094|NCT01100190|Device|NUVANCE Facial Rejuvenation System|The NUVANCE™ Facial Rejuvenation System is a partially absorbable porous mesh device implant with applicator.
16238095|NCT01100177|Drug|Sunitinib|Sunitinib 37.5mg/m2/d
16238097|NCT01100164|Drug|Eszopiclone|Eszopiclone - once a day (30 minutes before lying down to sleep for a period of 4 weeks of treatment)
16238098|NCT01100164|Drug|Zopiclone|Zopiclone - once a day (30 minutes before lying down to sleep for a period of 4 weeks of treatment)
16238099|NCT01100151|Drug|RDC-1036 (ALKS 37)|Capsules for oral administration
16238100|NCT01100151|Drug|Placebo|Capsules for oral administration
16238101|NCT01100125|Drug|sitagliptin|sitagliptin 100mg once daily, orally, for 24 weeks.
16238102|NCT01100125|Drug|insulin dose increase|insulin dose increase
16238103|NCT01100112|Drug|Budesonide|One Budesonide-MMX 9 mg tablet will be taken in the morning after breakfast for 8 weeks.
16238104|NCT01100099|Dietary Supplement|Gluten challenge.|The study population consists of 50 HLA-DQ2+ patients on a gluten free diet, both celiacs and uncertain celiacs. The patients will undergo a oral gluten challenge with four slices of bread daily for three days. Before challenge blood samples will be drawn for tetramer staining of gluten-specific T-cells. The analysis is done at the Institute of Immunology at Rikshospitalet, using FACS analysis. Small intestinal biopsies will be examined for morhological changes and inflammatory gene expression. These procedures with blood samples and biopsies will be repeated after gluten challenge. Registration for clinical symptoms and personality traits will be done by standardised and validated forms. A dietist will perform an interview of the patients.
16238105|NCT01100086|Drug|Reformulated OXY (oxycodone HCl)|Reformulated OXY 10-mg tablet x 1 dose taken without food
16238106|NCT01100086|Drug|Original OxyContin® (OXY) (oxycodone HCl)|Original OxyContin® (OXY) 10-mg tablet x 1 dose taken without food
16238107|NCT01100060|Drug|azithromycin (AZ) microsphere|AZ microsphere (2000 mg) single dose on Day 1.
16238108|NCT01100060|Drug|test chloroquine (CQ) formulation|Test CQ formulation, 620 mg CQ base, single dose on Day 1.
16238109|NCT01100060|Drug|azithromycin (AZ)|AZ IR 4 x 500 mg tablets, single dose on Day 1.
16238110|NCT01100060|Drug|chloroquine (CQ)|CQ 2 x 500 mg (600 mg CQ base) tablets, single dose on Day 1
16238111|NCT01100047|Drug|AZD5069|Oral suspension
16238112|NCT01100047|Drug|Placebo|Oral suspension
16238113|NCT01100034|Drug|Etanercept|Expected duration of 24 weeks as one course
16238114|NCT01100021|Drug|Tamsulosin and avanafil|tamsulosin - 0.4mg daily for 18 days; avanafil - 200 mg 1 x 2 days
16238115|NCT01100021|Drug|Doxazosin and avanafil|doxazosin - 1 mg 1 x 1 day; 2 mg 1 x 2 days; 4 mg 1 x 4 days; 8 mg 1 x 11 days; avanafil - 200 mg 1 x 1 day
16238116|NCT01100008|Procedure|Magnetic resonance imaging (MRI)|MRI cardiac and pulmonary with gadolinium
16238117|NCT01099995|Other|Hyperbaric oxygen therapy|one dive at 2 absolute atmosphere (1-hour plateau) with 30 min time for compression and decompression - oxygen was delivered via a full face mask at high concentration to achieve a 100% inspired fraction of oxygen or via mechanical ventilation
16238118|NCT01099995|Other|hyperbaric oxygen therapy|two dives at 2 absolute atmosphere (1-hour plateau) with 30 min of compression and 30 min of decompression - oxygen being delivered via a full face mask at 100% inspired oxygen fraction or via mechanical ventilation
16238119|NCT01099969|Device|Glidescope videolaryngoscope|
16238120|NCT01099969|Device|McGrath videolaryngoscope|
16238121|NCT01099969|Device|Non-styletted Endotrol endotracheal tube (ETT)|
16238122|NCT01099969|Device|Regular endotracheal tube (ETT) with Gliderite stylet|
16238123|NCT01099943|Other|Intervention: Education, Decision Support Tools|Clinic sites randomized to the intervention group will participate in an educational intervention comprised of lectures on antimicrobial resistance and implement decision support tools to guide primary care providers in appropriate antibiotic prescribing for common infectious conditions.
16238124|NCT01099930|Other|immuno-ablation and autologous CD34 selected hematopoietic stem cell transplantation (HSCT),|"Stem Cell Mobilization with Cyclophosphamide 4.5 gm/m2 and rhGCSF 10 ug/kg/d x 10 day.
~Stem Cell Collection with Cobe Spectra Stem Cell Purification with Miltenyi CliniMACS Stem Cell Transplant Conditioning with Busulphan 9.6 mg/kg iv, Cyclophosphamide 200 mg/kg iv, rabbit ATG 5 mg/kg iv followed by CD34 selected autologous hematopoietic stem cell transplant"
16238125|NCT01099930|Other|Standard Therapy|Patient will receive standard therapy as decided upon by their treating neurologist.
16238126|NCT01099917|Drug|Maitake|"Patients will receive the oral mushroom extract 3mg/kg by mouth twice daily for 3 months. Patients will serve as their own controls, with blood counts after Maitake compared with baseline counts. Rather than a wait list control, at study entry we will obtain from MDS patient charts 2 CBC/differential/platelet values drawn within 12-24 weeks prior to starting the protocol.
~Healthy control volunteers will be recruited to this study as participants for expanding the baseline normal values for neutrophil and monocyte function as measured by the respiratory burst test."
16238127|NCT01099904|Drug|RO5024048|multiple oral doses for 5 days
16238128|NCT01099891|Drug|rhEGF|rhEGF 50 μg/ml, spray type, twice a day
16238129|NCT01099891|Drug|Placebo|Placebo, Spray type, Twice a day
16238130|NCT01099878|Device|Cycling Exercise with Functional Electrical Stimulation|The subjects were randomly assigned to the cycling group (CG) performing cycling training without electrical stimulation or the FES-cycling group (FES-CG) performing the same training with the assistance of electrical stimulation. The duration of the training program was 20 minutes. The target cycling cadence was set at 45 rpm.
16238131|NCT01099878|Device|cycling exercise|The subjects were randomly assigned to the cycling group (CG) performing cycling training without electrical stimulation or the FES-cycling group (FES-CG) performing the same training with the assistance of electrical stimulation. The duration of the training program was 20 minutes. The target cycling cadence was set at 45 rpm.
16238132|NCT01099852|Other|biological sample collection|blood sample collection urine sample cerebrospinal fluid sample
16238133|NCT01099852|Other|Quality of life Questionnaire EuroQol®|Changes in quality of life, measured with the EuroQol® questionnaire 3 and 12 weeks after the onset of dengue fever symptoms.
16238134|NCT01099852|Other|Health Assessment Questionnaire - MDHAQ and RAPID3|Questionnaire used at the 3rd month of follow up.
16238135|NCT01099852|Other|Neuropathic Pain Questionnaire (DN4)|Questionnaire used during the follow up
16238136|NCT01099839|Drug|ASP1941|oral
16238137|NCT01099839|Drug|Miglitol|oral
16238138|NCT01099826|Behavioral|Tailored counseling|education tailored to baseline beliefs by trained counselor over phone
16240545|NCT01081535|Drug|ketorolac, fentanyl|intravenous PCA
16238139|NCT01099826|Behavioral|Motivational Interview|motivational interview by trained MI counselors by phone
16238140|NCT01099774|Drug|Bimatoprost 0.03% Formulation B Ophthalmic Solution|One drop administered in each eye, every evening, for 12 weeks
16238141|NCT01099774|Drug|Bimatoprost 0.03% Ophthalmic Solution|One drop administered in each eye, every evening, for 12 weeks
16238142|NCT01099761|Biological|ACE-031 0.5 mg/kg q4wk|ACE-031 0.5 mg/kg subcutaneously once every 4 weeks for 12 weeks.
16238143|NCT01099761|Biological|ACE-031 1.0 mg/kg q2wk|ACE-031 1.0 mg/kg subcutaneously once every 2 weeks for 12 weeks.
16238144|NCT01099761|Other|Placebo|Matching volume placebo subcutaneously every 2 or 4 weeks for 12 weeks.
16238145|NCT01099748|Drug|Methadone|Methadone 50 - 150 mg QD (Day 1)
16238146|NCT01099748|Drug|Lersivirine + Methadone|Lersivirine 1000 mg QD + Methadone 50 - 150 mg QD (Days 2-11)
16238147|NCT01099722|Drug|Flutiform|inhaler 2 puffs bd daily
16238148|NCT01099722|Drug|Symbicort Turbohaler|2 puffs bd daily
16238149|NCT01099709|Drug|Reformulated OXY (oxycodone HCl)|Reformulated OXY 10-mg tablet x 1 dose taken with food.
16238150|NCT01099709|Drug|Original OxyContin® (OXY) (oxycodone HCl)|Original OxyContin® (OXY) 10-mg tablet x 1 dose taken with food.
16238151|NCT01099696|Dietary Supplement|B. infantis 35624|B. infantis 35624 in white capsules
16238152|NCT01099696|Dietary Supplement|placebo|white placebo capsules
16238153|NCT01099683|Drug|NRL001|Single rectal administration of 2 mg NRL001 in a 2 g suppository
16238154|NCT01099683|Drug|Placebo|All subjects will receive rectal suppository containing placebo
16238155|NCT01099670|Drug|NRL001|Rectal suppository Placebo
16238156|NCT01099670|Drug|Placebo|Placebo
16238157|NCT01099657|Behavioral|Virtual Reality Hypnosis for chronic pain|At the time of their clinic visit,the subject will answer pain and anxiety questionnaires before experiencing Virtual Reality Hypnosis. After VRH, the will again answer Pain and anxiety questionnaires.
16238158|NCT01099657|Behavioral|Virtual Reality Distraction for Chronic Pain|At the time of their clinic visit,the subject will answer pain and anxiety questionnaires before experiencing Virtual Reality Distraction. After VRD, the will again answer Pain and anxiety questionnaires.
16238159|NCT01099644|Biological|131 I-8H9|Patients will be administered therapeutic dose of IP 131I-8H9 per the dose escalation regimen. 131I-8H9 pharmacokinetics will be studied by serial blood draws from indwelling venous lines. 131I-8H9 biodistribution will be studied by a single gamma camera scan about 5 days after IP injection where feasible.
16238160|NCT01099631|Biological|Salmonella typhimurium|Attenuated Salmonella typhimurium (virulent strain x4550) will be given orally in escalating dose groups: Level 1 = 10^5, Level 2 = 10^6, Level 3 = 10^7, Level 4 = 10^8, Level 5 = 10^9, Level 6 = 10^10.
16238161|NCT01099618|Drug|metformin|The study subject will receive metformin (MET) 1000 mg tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period.
16238162|NCT01099618|Drug|placebo|The study subject will receive a placebo tablet once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period.
16238163|NCT01099618|Drug|Sitagliptin|The study subject will receive a sitagliptin 100mg once a day as long as the patient maintains near-normoglycemic remission (BG < 130mg/dL and A1c <7%) during the 3-year follow-up period.
16238164|NCT01099605|Device|placement of a continuous infusion pump|Each infusion pump is placed below the mucosa of the rectum. Infusion of either the drug or saline will continue for approximately 3-4 days.
16238165|NCT01099605|Device|continuous infusion pump of bupivacaine|bupivacaine 0.25% at 4ml/hr for 3 to 4 days
16238166|NCT01099592|Drug|Citalopram|All patients will take citalopram once daily. Medication will be commercial tablets of 20 mg or 40 mg. All patients will start on a half dose of 10 mg and, if there are no severe side effects, will be increased to 20 mg after 1 week, and if the HAMD-24 at 6 weeks is not < 8, the dose will increase to 40 mg.
16238167|NCT01099579|Drug|Atazanavir powder|Powder, oral, dosed by weight. Participants who weighed 5 to <10 kg received atazanavir (ATV), 150 mg, and ritonavir (RTV), 80 mg; those who weighed 10 to <15 kg received ATV, 200 mg, and RTV, 80 mg; and those who weighed 15 to <25 kg received ATV, 250 mg, and RTV, 80 mg, once per day for 48 weeks or until pediatric indication is locally approved and participant meets requirements to receive appropriate formulation.
16238168|NCT01099579|Drug|Ritonavir oral solution|Oral solution, 80 mg/mL, once per day for 48 weeks or until pediatric indication is locally approved and participant meets requirements to receive appropriate formulation.
16238169|NCT01099579|Drug|Atazanavir capsules|Capsules, oral, dosed by weight in Stage 2. Patients who reached the age of 6 years or a weight of ≥25 kg transitioned from the powder to the capsule formulation of atazanavir (ATV). Patients who weighed 15 to <20 kg received ATV, 150 mg with RTV, 100 mg; those who weighed 20 to <40 kg received ATV, 200 mg, and RTV, 100 mg; and those who weighed at least 40 kg received ATV, 300 mg with RTV, 100 mg. RTV capsules or tablets were ingested with food immediately before or after ATV intake.
16238170|NCT01099579|Drug|Ritonavir capsules|Oral, capsules, 100 mg, administered in Stage 2 with atazanavir capsules, dosed by weight.
16238171|NCT01099566|Drug|Prasugrel|Prasugrel will be given as loading dose (60mg) on the first trial day two hours prior to endotoxin infusion. Prasugrel is an orally administered prodrug that is converted in the liver by CYP to its active metabolite.
16238172|NCT01099566|Drug|Placebo|A pharmacist not otherwise involved in the trial will encapsulate pills consisting of lactose-starch. Six pills will be administered as placebo 2 hours before LPS administration on trial day 1.
16238173|NCT01099553|Other|Educational video|Instructions to view an educational video about preparing for a colonoscopy
16238174|NCT01099553|Other|Written instructions|Written instructions on preparing for a colonoscopy
16238175|NCT01099540|Drug|Pazopanib|Pazopanib 800 mg qd daily
16238176|NCT01099527|Drug|Everolimus (RAD001)|dose escalation of capecitabine, everolimus
16238177|NCT01099527|Drug|Capecitabine|dose escalation of capecitabine, everolimus
16238178|NCT01099514|Drug|Nilotinib|D1~ Nilotinib 400 mg (2 capsules) PO BID q 28 days
16238179|NCT01099501|Dietary Supplement|Oxepa (enteral nutrition formula, ABBOTT), at a dose determined by a patient's energy expenditure and tolerance of enteral feeding.|Oxepa will be administered(enteral nutrition formula, ABBOTT), at a dose determined by a patient's energy expenditure and tolerance of enteral feeding
16238180|NCT01099501|Dietary Supplement|oxepa|A dose determined by a patient's energy expenditure and tolerance of enteral feeding.
16238181|NCT01099501|Dietary Supplement|Control group|Pulmocare or Jevity (enteral nutrition formula, ABBOTT)will be administered at a dose determined by a patient's energy expenditure and tolerance of enteral feeding.
16238182|NCT01099488|Procedure|Blood withdrawal|Healthy male or female adults between, and including, 18 and 50 years of age at the time of study start, having received GSK2231392A vaccine, were enrolled for blood withdrawal, at each study visit: Day 0, Day 14 and Day 180, to support the development of CD8+ T cell immunological detection assays.
16238183|NCT01099475|Procedure|Pringle manoeuvre 15 minutes|During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 2-times 15 minutes with 5 minutes reperfusion
16238184|NCT01099475|Procedure|Pringle manoeuvre 30 minutes|During parenchymal transection, the hepatoduodenal ligament will be clamped by a rubber band for 30 minutes with 5 minutes reperfusion
16238185|NCT01099462|Drug|Ibuprofen|Ibuprofen (10mg/kg BW) will be given orally if the temperature on presentation is higher than 38.0OC according to the decision of the attending physician.
16238186|NCT01099449|Drug|calcium gluconate|Given IV
16238187|NCT01099449|Drug|magnesium sulfate|Given IV
16238188|NCT01099449|Other|placebo|Given IV
16238189|NCT01099449|Drug|oxaliplatin|
16238190|NCT01099436|Drug|cyclophosphamide|
16238191|NCT01099436|Drug|docetaxel|
16238192|NCT01099436|Drug|doxorubicin hydrochloride|
16238193|NCT01099436|Drug|zoledronic acid|
16238194|NCT01099436|Procedure|neoadjuvant therapy|
16238195|NCT01099423|Procedure|timing of surgery|
16238196|NCT01099423|Genetic|gene expression analysis|
16238197|NCT01099423|Other|biologic sample preservation procedure|
16238198|NCT01099423|Other|laboratory biomarker analysis|
16238199|NCT01099423|Procedure|therapeutic conventional surgery|
16238200|NCT01099410|Procedure|Fiberoptic bronchoscopy|"which a flexible video instrument is passed via the nose or mouth, through the vocal cords and into the lungs. During the procedure, portions of the lungs will be washed (lavaged) with a salt water solution, to collect the alveolar macrophages. This procedure involves conscious sedation, so that a driver is required on the day of the bronchoscopy. The entire procedure, including placement of an intravenous line to administer medications, local anesthetics, the bronchoscopy itself, and the recovery period, takes about 2.5-3 hours."
16238201|NCT01099410|Procedure|blood draw|Blood will be collected at the enrollment visit to test the subject to exclude disorders that would make it unsafe to perform the bronchoscopy, including severe anemia, infection, or disorders of kidney or liver function.
16238202|NCT01099410|Procedure|intravenous catheter|An intravenous catheter is placed on the day of the bronchoscopy to permit administration of sedative medications.
16238203|NCT01099397|Other|Oral glucose tolerance test|For assessment of dysglycemia, 75 grams of glucose solution by mouth at 3 PEAR study visits for all enrolled participants: baseline, single drug therapy assessment, and dual drug therapy assessment.
16238204|NCT01099384|Behavioral|Written self-help materials|Written materials to help adolescents stop tobacco use
16238205|NCT01099384|Behavioral|Group behavioral counseling|group behavioral counseling (2 day weekend program)
16238206|NCT01099371|Other|exercise|progressive resistance training
16238207|NCT01099358|Drug|Cetuximab|Administered Intravenously
16238208|NCT01099358|Drug|Cisplatin|Administered Intravenously
16238209|NCT01099358|Drug|5 - Fluorouracil|Administered Intravenously
16238210|NCT01099345|Procedure|cystometry (CMG)|recording device measuring pressures though catheters placed in bladder and rectum
16238211|NCT01099345|Procedure|polysomnography (PSG)|Recording device measuring sleep activity through electrodes attached to the subject
16238212|NCT01099332|Other|Gastro-retentive zinc cysteine tablet|Oral, one tablet, once daily with water for 6 months.
16238213|NCT01099332|Other|Tablet identical physically to active comparator containing some lactose|Oral, once daily, with water, 6 months.
16238214|NCT01099319|Dietary Supplement|Renalof|One 325 mg Renalof tablet (Orally administered) every 8 hours, for 6 months.
16238215|NCT01099319|Dietary Supplement|Placebo|One Placebo tablet (Orally administered) every 8 hours, for 6 months
16238216|NCT01099306|Other|Pharmaceutical care services|Patients' metabolic components were assessed and managed collaboratively by focused care plan designed by the clinical pharmacist and approved by the physician.Pharmacist emphasized the change in lifestyle, particularly weight loss and physical activity as a first line therapy for at least 3 months, patients were started on drug therapy when needed as recommended by clinical guidelines.
16238217|NCT01099280|Drug|SYNPITAN FORT 5 IU|A standard intravenous oxytocin was administered 6 hours after the insertion of the vaginal pessary. An initial dose of 2 mU/min was increased at 30 minute intervals by 2 mU/min to a maximum dose 32 mU/min or until four contractions in 10 minutes was achieved. Once started, oxytocin infusion was continued to delivery unless otherwise indicated. The pessary has been removed if it was still present 12 h after placement; or if worrisome FHR pattern persisted
16238218|NCT01099280|Drug|Propess,SYNPITAN FORT|a single dose sustained-released dinoprostone into the posterior vaginal fornix. A standard intravenous oxytocin was administered 6 hours after the insertion of the vaginal pessary. An initial dose of 2 mU/min was increased at 30 minute intervals by 2 mU/min to a maximum dose 32 mU/min or until four contractions in 10 minutes was achieved
16238219|NCT01099228|Other|131-I MIBG and 111-In pentetreotide|Subjects will receive 131I MIBG and 111In pentetreotide(surrogate for Y90-DOTATOC)
16238220|NCT01099228|Other|131-I MIBG and In-111 DOTATATE|131I MIBG and In-111 DOTATATE (surrogate for 177Lu DOTATATE)
16238221|NCT01099215|Biological|PVS-10200|PVS-10200 is composed of allogeneic human aortic endothelial cells cultured in a gelatin matrix.
16238222|NCT01099202|Drug|Procrit (epoetin alfa)|Starting dose 40,000 Units subcutaneously once a week during your regularly scheduled chemotherapy for up to 6 courses of chemotherapy (around 5 months).
16238223|NCT01099176|Drug|To compare monotherapies and combined therapy with each other|"Each patient received two tablets per day. Time interval between pills - 12 hours.
~In monotherapies patients received one active tablet and one placebo, in combined treatment both pills were active and in placebo group patients taken two placebo tablets"
16238224|NCT01099163|Dietary Supplement|Tonalin SG1000T FFA|
16238225|NCT01099150|Dietary Supplement|Dark chocolate enriched in flavan-3-ols and procyanidins|Acute consumption (within 15 minutes) of 60 g of chocolate containing ~900 mg of total flavan-3-ols and procyanidins.
16238226|NCT01099150|Dietary Supplement|Standard dark chocolate|Acute consumption (within 15 minutes) of 60 g of chocolate containing ~400 mg total flavan-3-ols and procyanidins.
16238227|NCT01099150|Dietary Supplement|White chocolate|Acute consumption (within 15 minutes) of 60 g of white chocolate containing no flavan-3-ols and procyanidins.
16238228|NCT01099137|Drug|Vildagliptin|Vildagliptin 50mg twice a day, orally, for 24 weeks
16238229|NCT01099137|Drug|Sulphonylurea dose-up|glimepiride dose will be increased by 50% to uncontrolled diabetic patients with glimepiride and metformin
16238230|NCT01099124|Drug|M2ES|polyethylene glycol rh recombinant endostatin
16238231|NCT01099085|Drug|Simvastatin|simvastatin 40 mg qd daily
16238232|NCT01099085|Drug|Placebo|Placebo
16238233|NCT01099072|Drug|Methylphenidate+placebo|methylphenidate at a dose of 20-30 mg/day depending on weight (20 mg/day for <30 Kg and 30 mg/day for >30 Kg)+ Placebo
16238234|NCT01099072|Drug|methylphenidate+carnitine|methylphenidate at a dose of 20-30 mg/day depending on weight (20 mg/day for <30 Kg and 30 mg/day for >30 Kg)+ Carnitine 500-1500 mg/day (depending on weight )
16238235|NCT01099059|Drug|Amantadine|Amantadine 100-150 mg depending on weight (100 mg/day for <30 Kg and 150 mg/day for >30 Kg)
16238236|NCT01099059|Drug|ritalin|ritalin at a dose of 20-30 mg/day depending on weight (20 mg/day for <30 Kg and 30 mg/day for >30 Kg)
16238237|NCT01099046|Behavioral|Lifestyle|water intake, tympanic tubing, regular sleep
16238238|NCT01099007|Behavioral|In Person|Participants in the In Person group have weekly visits for the 12 weeks to the research office. The first visit can last up to one and a half hours and each subsequent visit can last approximately one hour. Group meetings provide appropriate nutrition and physical activity information as well as behavioral change strategies. Sessions also include some light physical activity (equal to brisk walking).
16238239|NCT01099007|Behavioral|At Home|Participants in the At Home group receive a workbook from the research staff at their baseline visit that outlines an accepted nutrition and physical activity program to complete on their own.
16238240|NCT01098994|Dietary Supplement|Vitamin E|Daily administration of 400 IU natural d-alpha tocopherol acetate for 8 weeks
16238241|NCT01098994|Other|Dummy pills|Daily placebo administration for 8 weeks
16238242|NCT01098981|Device|Transcranial ultrasound as an adjunctive therapy to tPA|"tPA per approved labeling administered over 60 minutes
~Ultrasonic headframe with active insonation for 120 minutes"
16238243|NCT01098981|Drug|Standard of care tPA therapy for acute ischemic stroke|"tPA per approved labeling administered over 60 minutes
~Ultrasonic headframe with sham (inactive) insonation for 120 minutes"
16238244|NCT01098968|Behavioral|Physical activity program|School intervention program specifically designed to increase health-related physical fitness
16238245|NCT01098955|Behavioral|Acceptance and Commitment Therapy|6 x 60-minute counseling sessions delivered over a 5-week period
16238246|NCT01098955|Behavioral|Motivational and Behavioral Counseling|6 x 60-minute counseling sessions delivered over a 5-week period
16238247|NCT01098955|Drug|Varenicline|2 mg daily for 12 weeks
16238248|NCT01098916|Radiation|Home X-rays|X-rays examinations performed at home
16238249|NCT01098916|Radiation|X-rays in hospital|
16238250|NCT01098890|Drug|Tissue Plasminogen Activator|2mg tPA will be given every twelve hours for a maximum of 5 doses
16238251|NCT01098890|Drug|Placebo|Placebo will be administered every 12 hours for a maximum of 5 doses.
16238252|NCT01098877|Drug|PF-04634817 Placebo|Oral solution, placebo, single dose
16238253|NCT01098877|Drug|PF-04634817|Oral solution, 1mg, single dose
16238254|NCT01098877|Drug|PF-04634817|Oral solution, 3mg, single dose
16238255|NCT01098877|Drug|PF-04634817|Oral solution, 10mg, single dose
16238256|NCT01098877|Drug|PF-04634817|Oral solution, 30mg, single dose
16238257|NCT01098877|Drug|PF-04634817|Oral solution, 100mg, single dose
16238258|NCT01098877|Drug|PF-04634817|Oral solution, 300mg, single dose
16238259|NCT01098877|Drug|PF-04634817|Oral solution, 600mg, single dose
16238260|NCT01098877|Drug|PF-04634817|Oral solution, 900mg, single dose
16238261|NCT01098877|Drug|PF-04634817|Oral solution, up to 900mg, single dose after food
16238262|NCT01098877|Drug|PF-04634817 Placebo|Oral solution, placebo, single dose after food
16238263|NCT01098864|Device|transcranial magnetic stimulation|low frequency (1 Hz) repeated transcranial magnetic stimulation will be delivered to the dorsal lateral prefrontal cortex (DLPFC) area for a period of 15 minutes to test for effect on executive function (e.g., decision choice and subjective value). Four sessions will be conducted per subject; 2 active stimulations,(1 left DLPFC, 1 right DLPFC) and 2 sham stimulations (1 left DLPFC, 1 right DLPFC) with a minimum of 48 hours between every stimulation. Pre and post stimulations measures of cognitive and executive function will be collected and analyzed for significant differences.
16238264|NCT01098838|Drug|LCL161|
16238265|NCT01098825|Other|web-based survey|Anonymous web-based survey
16238266|NCT01098812|Device|Tecnis ZCB00 IOL (control)|Tecnis 1-piece acrylic IOL
16238267|NCT01098812|Device|Toric Intraocular lens|Toric acrylic intraocular lens with various cylinder powers
16238268|NCT01098786|Biological|Cell-derived A/H1N1 influenza HA vaccine|Single group vaccinated
16238269|NCT01098760|Drug|Sorafenib (Nexavar, BAY43-9006) Sorafenib (Nexavar, BAY43-9006) + Nerison Fatty Ointment Sorafenib (Nexavar, BAY43-9006)+Neribas Fatty Ointment|Orally taken Sorafenib tablets of 400mg (2x200mg) twice daily (bid) in a continuous schedule. - For patients in Nerisone subgroup: additionally prophylactic use of Nerisone Fatty Ointment (1 g of Nerisone contains 1 mg (0.1%) diflucortolone valerate) cream for hands and feet, twice daily for 3 weeks - For patients in Neribas subgroup: additionally prophylactic use of Neribas Fatty Ointment (non-corticosteroid containing) cream for hands and feet, twice daily for 3 weeks
16238270|NCT01098747|Drug|Novel Ibuprofen|Single-dose of novel ibuprofen (equal to 400 mg ibuprofen)
16238271|NCT01098747|Drug|Standard Ibuprofen|Single-dose of standard ibuprofen (400mg)
16238272|NCT01098747|Drug|Standard Ibuprofen|Single-dose of standard ibuprofen (400mg)
16238273|NCT01098747|Drug|Placebo|Single-dose of placebo
16240546|NCT01081483|Drug|ABT-072|See arm description for more information
16238274|NCT01098734|Drug|WBI-1001|A 12-week study to assess the efficacy, safety and tolerability of topically applied WBI-1001 creams. First 6 weeks will be double-blinded, placebo-controlled and the following 6 weeks will be double-blinded, non-placebo- controlled. After 6 weeks patients in Groups 2 and 3 will continue double-blinded treatment for a further 6 weeks, but patients in Group 1 will enter a 6-week double-blinded phase with one of the two active creams (half treated with 0.5% and half with 1.0% WBI-1001 cream). All patients treated twice daily (BID).
16238275|NCT01098721|Drug|WBI-1001|Comparison of two doses (0% and 1.0%) of the the WBI-1001 cream applied topically, twice daily for 12 weeks.
16238276|NCT01098695|Other|Ecological Family Intervention and Treatment (EcoFIT)|Includes the Family Check-Up (in-person intake, family video observations and Assessment questionnaires used to provide and tailored feedback using motivational interviewing techniques) as well as continued tailored intervention services using the Everyday Parenting Curriculum.
16238277|NCT01098656|Drug|lenalidomide|"The starting dose of lenalidomide is 25 mg orally once daily on days 1-21 of repeated 28-day cycles.
~Dosing is continued or modified based upon clinical and laboratory findings (dose reductions: 20 mg, 15 mg, 10 mg and 5 mg)"
16238278|NCT01098643|Other|computer-assisted intervention|
16238279|NCT01098643|Other|medical chart review|
16238280|NCT01098643|Other|questionnaire administration|
16238281|NCT01098643|Other|survey administration|
16238282|NCT01098630|Other|Medical Chart Review|Patients' medical record information is collected and staff complete the treatment review form
16238283|NCT01098630|Other|Questionnaire Administration|Ancillary studies
16238284|NCT01098604|Device|32mm ceramic head group|we performed THA using 32mm ceramic head in this group.
16238285|NCT01098604|Device|28mm ceramic head group|we performed THA using 28mm ceramic head in this group.
16238286|NCT01098591|Other|cell therapy|
16238287|NCT01098578|Drug|Floseal|Received 1 syringe of Floseal as treatment for posterior epistaxis.
16238288|NCT01098565|Device|Study device HFR0001|Study device will be tested for up to 2 hours prior to chronic device implant.
16238289|NCT01098539|Biological|albiglutide|albiglutide weekly subcutaneous injection + sitagliptin matching placebo
16238290|NCT01098539|Drug|sitagliptin|albiglutide matching placebo + sitagliptin (25mg, 50mg or 100mg depending on level of renal impairment)
16238291|NCT01098526|Drug|GSK1349572|GSK1349572 is an experimental drug under development for the treatment of HIV. It is in the class of integrase inhibitors.
16238292|NCT01098526|Drug|Efavirenz|Efavirenz is a drug that has been approved by the FDA for the treatment of HIV. It is in the class of non-nucleoside reverse trancriptase inhibitors.
16238293|NCT01098513|Drug|GSK1349572 formulation AP|GSK1349572 50 mg single dose fasted.
16238294|NCT01098513|Drug|GSK1349572 formulation AW|GSK1349572 formulation AW 50 mg single dose in Part A and 75 to 200 mg fasted or with moderate or high fat meal in Part B.
16238295|NCT01098513|Drug|GSK1349572 formulation AX|GSK1349572 formulation AX 50 mg in Part A and 75-200 mg fasted or with a moderate or high fat meal in Part B
16238296|NCT01098500|Drug|Tyrosine kinase inhibitors|Lapatinib, erlotinib, gefitinib, dasatinib, imatinib, nilotinib (analyzed as a class of drugs, not by individual drug)
16238297|NCT01098487|Drug|Eltrombopag olamine|Thrombopoietin receptor agonist
16238298|NCT01098474|Biological|GSK's investigational vaccine 692342|Intramuscular, 1 or 2 doses
16238299|NCT01098474|Biological|Tritanrix™ HB+Hib|Intramuscular, 3 doses
16238300|NCT01098474|Biological|Prevnar™|Intramuscular, 3 doses
16238301|NCT01098474|Biological|Polio Sabin™|Oral, 3 doses
16238302|NCT01098474|Biological|Menjugate™|Intramuscular, 3 doses
16238303|NCT01098461|Biological|albiglutide|subcutaneous injection of albiglutide
16238304|NCT01098461|Biological|placebo|subcutaneous injection of placebo to match albiglutide
16238305|NCT01098448|Other|scaling and root planing|scaling and root planing as a single therapy
16238306|NCT01098448|Drug|local tetracycline|local delivery of tetracycline fibers releasing approximately 1.7 mg/tooth in all pockets >5mm
16238307|NCT01098448|Drug|systemic metronidazole and amoxicillin|systemic metronidazole (250 mg tid x 14) and amoxicillin (500 mg bid x 14
16238308|NCT01098448|Other|surgery|periodontal surgery in residual pockets of >4mm
16238309|NCT01098448|Drug|local antibiotics and systemic metronidazole and amoxicillin|1.7 mg/tooth tetracycline fiber plus metronidazole (250 mg tid x14d)and amoxicillin (500 mg bid x 14d)
16238310|NCT01098448|Other|local tetracycline and periodontal surgery|local delivery of tetracycline fibers releasing approximately 1.7 mg/tooth in all pockets >5mm and periodontal surgery in residual pockets of >4mm
16238311|NCT01098448|Other|periodontal surgery and systemic metronidazole and amoxicillin|surgery in residual pockets >4mm and metronidazole (250mg tidx14d) and amoxicillin (500mg bidx14d)
16238312|NCT01098448|Other|surgery, local tetracycline, systemic metronidazole and amoxicillin|periodontal surgery in residual pockets >4mm, tetracycline ibers releasing approximately 1.7 mg/tooth in pockets >5mm, systemic metronidazlo (250mg tidx14d) and amoxicillin (500 mg bidx14d)
16238313|NCT01098435|Drug|RDC-0313 (ALKS 33)|Capsules for daily oral administration
16238314|NCT01098435|Drug|Placebo|Capsules containing lactose and no active drug for daily oral administration
16238315|NCT01098422|Device|Yttrium-90 Radioactive Resin Microspheres|An injectable formulation of the radioisotope yttrium-90 encapsulated in resin microspheres with potential antineoplastic activity.
16238316|NCT01098409|Drug|sodium nitrite|0.2mcg/kg/min or 1mcg/kg/min intravenous for 30minutes at 1ml/min
16238317|NCT01098409|Drug|0.9% sodium chloride|intravenous 0.9% sodium chloride over 30minutes at 1ml/min
16238318|NCT01098383|Drug|Acetyl-Choline Esterase Inhibitors and Choline supplements|"Donepezil will be used at initial dose of 2.5 mg/day (during the first two weeks), and an increased dose of 5 mg/day (from the 3rd week and on), according to the treatment protocol listed below. The tablets will be taken during breakfast.
~AChE inhibitors are considered as potent agents for clinical use in Alzheimer's and Parkinson's dementias (Wevers & Schroder, 1999) and treatment with these agents was proven to be well-tolerated, safe and effective in these populations. Cholinergic side effects are generally transient, mild and dose-related, and primarily include diarrhea, nausea, and vomiting.
~Choline tablets will be taken at daily doses of 250 mg (in children with up to 40 kg body weight) and 500 mg (in children with more than 40 kg body weight), based on half of the adult daily dose."
16238319|NCT01098383|Drug|Indistinguishable placebo tablets, matching both donepezil and choline|Indistinguishable placebo tablets, matching both donepezil and choline, will be given in the same amounts and schedules
16238320|NCT01098357|Drug|Biochaperone PDGF-BB Low dose|BioChaperone PDGF-BB low dose is applied as a spray every two days at the dose of 12.5 µg/cm2 for up to 20 weeks
16238321|NCT01098357|Drug|Biochaperone PDGF-BB High dose|BioChaperone PDGF-BB high dose is applied as a spray every two days at the dose of 25 µg/cm2 for up to 20 weeks
16238322|NCT01098357|Drug|Regranex|Regranex gel is applied once daily at the dose of 6.25 µg/cm2 for up to 20 weeks
16238323|NCT01098357|Drug|Biochaperone PDGF-BB Very Low Dose|BioChaperone PDGF-BB Very Low Dose sprayed on the wound every two days (e.g., Mondays, Wednesdays and Fridays) for 20 weeks or until complete wound healing, at the dose of 4 µg/cm²/application
16238324|NCT01098344|Drug|Notch signaling pathway inhibitor MK0752|
16238325|NCT01098344|Drug|gemcitabine hydrochloride|
16238326|NCT01098344|Other|imaging biomarker analysis|
16238327|NCT01098344|Other|laboratory biomarker analysis|
16238328|NCT01098344|Other|pharmacological study|
16238329|NCT01098331|Other|counseling intervention|
16238330|NCT01098331|Other|educational intervention|
16238331|NCT01098331|Procedure|quality-of-life assessment|
16238332|NCT01098331|Procedure|therapeutic conventional surgery|
16238333|NCT01098331|Radiation|iodine I 125|
16238334|NCT01098331|Radiation|palladium Pd 103|
16238335|NCT01098318|Dietary Supplement|Herbal extract|340-1,360 mg daily
16238336|NCT01098318|Drug|Sertraline|50-200 mg daily
16238337|NCT01098318|Other|Lactose monohydrate|1-4 capsules daily
16238338|NCT01098305|Drug|Varenicline|Participants will be randomized to receive varenicline or placebo for 12 weeks. The dosing regimen consistent with FDA guidelines will be used: Day 1-Day 3 (0.5mg once daily); Day 4-Day 7 (0.5mg twice daily); and Day 8-Day 84 (1.0mg twice daily).
16238339|NCT01098305|Behavioral|Counseling|All participants will be provided with a structured behavioral counseling program, involving 6 counseling sessions by a trained NDDTC counselor. This will be a manual-based intervention and revised as needed for cultural relevance and sensitivity by Dr. Stigler. The intervention is designed to enhance awareness of the harmful effects of smokeless tobacco, assist the person in developing skills to quit and avoid relapse, and instruct the smokeless tobacco user on medication adherence, as recommended by experts in the field.
16238340|NCT01098266|Drug|NGR-hTNF plus Best Investigator's Choice (BIC)|"NGR-hTNF: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
~Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
~Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
~Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
~Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
~Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)"
16238341|NCT01098266|Drug|Placebo plus Best Investigator's Choice (BIC)|"Placebo: 0.8 mcg/m² as 60-minute intravenous infusion every week until confirmed evidence of disease progression or unacceptable toxicity occurs.
~Best Supportive Care: antibiotics, analgesics, antiemetics, thoracentesis, pleurodesis, blood transfusions, nutritional support, and focal external-beam radiation for control of pain, cough, dyspnea, or hemoptysis
~Investigator's Choice: one of the following single-agent chemotherapy might be administered in combination:
~Doxorubicin: 60-75 mg/m2 every 3 weeks, for a maximum of 6 cycles
~Gemcitabine: 1,000-1,250 mg/m2 on days 1 and 8, every 3 weeks, for a maximum of 6 cycles
~Vinorelbine: 25 mg/m2 iv (or 60 mg/m2 per os) on days 1 and 8, every 3 weeks, for a maximum of 6 cycles (or weekly for 12 weeks)"
16238342|NCT01098253|Behavioral|Adherence Intervention|Factors affecting adherence are addressed using a problem solving process.
16238343|NCT01098240|Drug|CP-601,927|CP-601,927 1-2 mg twice per day, oral 1 mg tablets, for 6 weeks.
16238344|NCT01098240|Other|Placebo|Matching placebo tablets, taken orally, twice per day, for 6 weeks.
16238345|NCT01098201|Drug|Certolizumab|Subcutaneous administration on a monthly basis for six months
16238346|NCT01098188|Drug|LFB-R603|intravenous administration, dose-escalation study
16238347|NCT01098149|Other|BD and BVC, AFB|Some patients are randomized into the AFB, the others into the BD and BVC
16238348|NCT01098136|Other|Chiropractic|Manual treatment of musculoskeletal complaints
16238349|NCT01098136|Other|Conventional medical intervention|Medical, physiotherapy
16238350|NCT01098136|Other|Conventional and alternative intervention|Medical and alternative methods for treatment of pelvic pain syndromes
16238351|NCT01098110|Drug|Asenapine 5 mg|Asenapine 5 mg fast dissolving tablets sublingually without water twice daily, in the morning (around 8 am) and in the evening (around 8 pm), on Day 1 only or for 6 weeks.
16238352|NCT01098110|Drug|Asenapine 10 mg|Participants receive on Day 2, 10 mg BID of fast dissolving tablets sublingually without water twice daily, in the morning (around 8 am) and in the evening (around 8 pm), for 6 weeks.
16238353|NCT01098110|Drug|Placebo|A matching placebo of asenapine sublingual tablet not containing asenapine
16238354|NCT01098097|Biological|Peginterferon alpha|Peginterferon alpha given in combination with ribavirin according to local labeling guidelines
16238355|NCT01098097|Drug|Ribavirin|Ribavirin given in combination with peginterferon alpha according to local labeling guidelines
16238356|NCT01098084|Drug|Decitabine|20mg/m2/day, one hour intravenous infusion, every day during 5 days
16238357|NCT01098071|Drug|mometasone furoate nasal spray|One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months
16238358|NCT01098058|Other|CBT plus treatment as usual|16 one-hour therapy sessions taking place over 42 weeks in addition to usual medical follow-up appointments
16238359|NCT01098058|Other|Treatment as usual|Treatment as usual appointments at the Adult ADHD Service - typically one 30-minute appointment every three to six months
16238481|NCT01097096|Biological|Alum|An adjuvant (additive to increase potency ) of low, middle or high doses which was mixed with reconstituted active CAD106
16238482|NCT01097096|Biological|MF59|An adjuvant (additive to increase potency) of low, middle and high doses which was mixed with reconstituted active CAD106
16238483|NCT01097083|Drug|Coriolus Versicolor|
16238360|NCT01098032|Device|RenalGuard system|The RenalGuard™ System (PLC Medical Systems, Inc.) is a real-time measurement and real time matched fluid replacement device designed to accommodate the RenalGuard Therapy. The RenalGuard Therapy is based on the concept demonstrated by clinical data that high urine output is beneficial to patients with impaired baseline renal function who receive intravascular iodinated contrast medio (CM). The RenalGuard System seems to be ideal for the prevention of CI-AKI, by allowing an optimal urine flow rate >300 ml/h. It is known that excessive diuresis can cause dehydration which increases the risk to the kidneys from CM. The RenalGuard System should allow the patient to achieve high urine output safely by maintaining the intravascular blood volume and avoiding the risk of over-or-under-hydration.
16238361|NCT01098032|Drug|Systemic alone therapy|Patients allocated to the Systemic alone therapy group will receive 154 mEq/l of sodium bicarbonate in dextrose and H2O, according to the protocol reported by Merten et al. The initial intravenous bolus was 3 ml/kg per hour for 1 hour immediately before contrast injection. Following this, patients will receive the same fluid at a rate of 1 ml/kg per hour during contrast exposure and for 6 hours after the procedure. All patients will receive NAC (Fluimucil, Zambon Group SpA, Milan, Italy) orally at a dose of 1200 mg twice daily on the day before and on the day of administration of the contrast agent (total of 2 days)
16238362|NCT01098019|Drug|Xeomin|Patients will receive Xeomin only at Day 0.
16238363|NCT01098019|Drug|Placebo / Xeomin|Patients will receive 0.9% mL NaCl alone at Day 0. After unblinding (at week 12) patients who were randomized to placebo will receive Xeomin.
16238364|NCT01098006|Other|Blood withdrawal|A single blood sample was to be taken from all subjects at the study visit. No study-related treatment was given to the study participants.
16238365|NCT01097993|Other|1-fermented dairy product|Arm 1 - Intervention 1 (probiotics)
16238366|NCT01097993|Other|2- milk-based non-fermented dairy product (control product)|Arm 2 - Intervention 2 (control)
16238367|NCT01097980|Drug|Trazodone|50 mg/d trazodone was upwardly titrated to 100 mg/d over one week and then maintained
16238368|NCT01097980|Drug|Placebo|Placebo
16238369|NCT01097967|Other|CPAP|
16238370|NCT01097941|Biological|Live Attenuated H1N1 Influenza Vaccine|0.2 ml dose of live monovalent vaccine delivered through nasal spray, 2 doses given 28 days apart
16238371|NCT01097941|Biological|Influenza A (H1N1) 2009 Monovalent Vaccine|0.5 ml IM, 2 doses given 28 days apart
16238372|NCT01097941|Biological|Influenza A (H1N1) 2009 Monovalent Vaccine/ Influenza A (H1N1) Monovalent Vaccine Live|0.5 ml IM given X1 with 0.1 ml intranasally given 28 days later
16238373|NCT01097928|Procedure|Catheter directed debulking of Pulmonary Embolus|A catheter will be used to break up the pulmonary embolism
16238374|NCT01097902|Drug|Ibuprofen|800 mg oral one time only
16238375|NCT01097902|Drug|Placebo tablet|Placebo tablet oral one time only
16238376|NCT01097889|Dietary Supplement|Fortified blended foods, Corn Soya Bean Flour (CSB) with oil.|A daily ration equivalent of 300g CSB and 32g vegetable oil Bi-weekly distribution of premix of 4.2kg CSB with 0.5L vegetable oil. Estimated 1413 kcal, 47g protein
16238377|NCT01097889|Dietary Supplement|RUSF (ready-to-use supplementary foods) Supplementary Plumpy®|"Peanut-based fortified supplement
~One 92g sachet eaten throughout the day Bi-weekly distributions of 14 sachets 500 kcal and 13g protein"
16238378|NCT01097876|Drug|PF-04447943 25 mg|25 mg PF-04447943 BID for 7 days (period 1) 7 day washout (no drug) 7 days of 5 mg donepezil QD; 14 days 10 mg QD (Period 2) 7 days of 10 mg donepezil QD and 25 mg PF-04447943 BID (Period 3)
16238379|NCT01097876|Drug|Placebo PF|Placebo BID for 7 days (period 1) 7 day washout (no drug) 7 days of 5 mg donepezil QD; 14 days 10 mg QD (Period 2) 7 days of 10 mg donepezil QD and Placebo BID (Period 3)
16238380|NCT01097863|Device|nelfilcon A contact lens, modified inversion indicator|Investigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with modified inversion indicator
16238381|NCT01097863|Device|nelfilcon A contact lens, no inversion indicator|Investigational, nelfilcon A, toric, soft contact lens for daily disposable wear, with no inversion indicator
16238382|NCT01097863|Device|nelfilcon A contact lens, inversion indicator|Commercially marketed, nelfilcon A, toric, soft contact lens for daily disposable wear, with inversion indicator
16238383|NCT01097850|Drug|henna paste|Henna paste will be applied to either the left hand/foot or right hand/foot, along with CeraVe moisturizer to both hands/feet
16238384|NCT01097837|Other|Non-interventional|This is an observational study conducted by anonymous survey. There is no intervention.
16238385|NCT01097811|Drug|Erythromycin|250 mg orally q.i.d.
16238386|NCT01097811|Drug|Neomycin|1 g orally q.i.d.
16238387|NCT01097798|Drug|Aliviador|The study medication should be applied regimen of 8/8 hours over 2 days.
16238388|NCT01097798|Drug|Gelol|The study medication should be applied regimen of 8/8 hours over 2 days.
16238389|NCT01097785|Drug|Simvastatin|40 mg, P.O.,daily for 30 days
16238390|NCT01097785|Drug|Placebo|1 capsule daily for 30 days
16238391|NCT01097772|Device|Implant of Ovation Abdominal Stent Graft System|Single occurrence permanent implant of AAA device.
16238392|NCT01097759|Procedure|Surgery|Hemorrhoidectomy using the LigaSure sealing device or hemorrhoidopexy using the stapler
16238393|NCT01097746|Biological|Bevacizumab|Given IV
16238394|NCT01097746|Drug|Carboplatin|Given IV
16238395|NCT01097746|Drug|Paclitaxel|Given IV
16238396|NCT01097733|Other|Randomization of Pre-knowledge of CT coronary venography|
16238397|NCT01097707|Drug|LY500307|Administered orally, daily for 24 weeks
16238398|NCT01097707|Drug|Placebo|Administered orally, daily for 24 weeks
16238399|NCT01097694|Drug|Imatinib mesylate|Imatinib will be initiated at an oral dose of 200 mg (two 100 mg film-coated tables) per day during the first two weeks of treatment. If the treatment is well tolerated, an up-titration to 400 mg daily (four 100 mg film-coated tables) will occur.
16238400|NCT01097694|Drug|Placebo|Placebo
16238401|NCT01097681|Drug|ASP1941|oral
16238402|NCT01097668|Biological|ATX-MS-1467|Disease specific immune modulating treatment for multiple sclerosis
16238403|NCT01097642|Drug|Cetuximab|Cetuximab will be given at 400mg/m^2 IV over 120 minutes for its initial loading dose on day 1 of the first of four 21 day cycles. It will then be administered on a weekly basis at 250 mg/m^2 IV over 60 minutes.
16238404|NCT01097642|Drug|Ixabepilone|Ixabepilone will be given at 40mg/m^2 IV over 180 minutes on day 1 of each of four 21 day cycles.
16238405|NCT01097629|Drug|Suvorexant High Dose (HD)|Suvorexant 40 mg + placebo matching suvorexant 20 mg for participants <65 years old; Suvorexant 30 mg + placebo matching suvorexant 15 mg for participants ≥65 years old; all study drug is tablet for oral administration, taken once daily at bedtime. Participants receive this dose during the 3-month Treatment (TRT) Phase. During the 1-week double-blind (DB) Run-out (RO) following the TRT phase, participants in this study arm receive the noted suvorexant dose or placebo, in a 1:1 ratio. During the 2-week single-blind Run-in period prior to randomization all participants receive placebo to suvorexant once daily at bedtime.
16238406|NCT01097629|Drug|Suvorexant Low Dose (LD)|Suvorexant 20 mg + placebo matching suvorexant 40 mg for participants <65 years old; Suvorexant 15 mg + placebo matching suvorexant 30 mg for participants ≥65 years old; all study drug is tablet for oral administration, taken once daily at bedtime. Participants receive this dose during the 3-month TRT Phase. During the 1-week DB RO following the TRT phase, participants in this study arm receive the noted suvorexant dose or placebo, in a 1:1 ratio. During the 2-week single-blind Run-in period prior to randomization all participants receive placebo to suvorexant once daily at bedtime.
16238407|NCT01097629|Drug|Comparator: Placebo|Matching placebos to suvorexant 40 mg and 20 mg for participants <65 years old; matching placebos to suvorexant 30 mg and 15 mg for participants ≥65 years old; all study drug is tablet for oral administration, taken once daily at bedtime. Placebo is a third treatment arm for comparison to the two active (suvorexant) treatment arms during the 3-month TRT Phase. During the 1-week DB RO following the TRT phase, participants in this study arm continue to receive placebo. During the 2-week single-blind Run-in period prior to randomization all participants receive placebo to suvorexant once daily at bedtime.
16238408|NCT01097616|Drug|Suvorexant High Dose (HD)|Suvorexant 40 mg + placebo matching suvorexant 20 mg for participants <65 years old; Suvorexant 30 mg + placebo matching suvorexant 15 mg for participants ≥65 years old; all study drug is tablet for oral administration, taken once daily at bedtime. Participants receive this dose during the 3-month TRT Phase and, if applicable, the optional 3-month EXT Phase. During the 1-week double-blind (DB) Run-out (RO) following the TRT/EXT phase, participants in this study arm receive the noted suvorexant dose or placebo, in a 1:1 ratio. During the 2-week single-blind Run-in period prior to randomization all participants receive placebo to suvorexant once daily at bedtime.
16238409|NCT01097616|Drug|Suvorexant Low Dose (LD)|Suvorexant 20 mg + placebo matching suvorexant 40 mg for participants <65 years old; Suvorexant 15 mg + placebo matching suvorexant 30 mg for participants ≥65 years old; all study drug is tablet for oral administration, taken once daily at bedtime. Participants receive this dose during the 3-month TRT Phase and, if applicable, the optional 3-month EXT Phase. During the 1-week DB RO following the TRT/EXT phase, participants in this study arm receive the noted suvorexant dose or placebo, in a 1:1 ratio. During the 2-week single-blind Run-in period prior to randomization all participants receive placebo to suvorexant once daily at bedtime.
16238410|NCT01097616|Drug|Comparator: Placebo|Matching placebos to suvorexant 40 mg and 20 mg for participants <65 years old; matching placebos to suvorexant 30 mg and 15 mg for participants ≥65 years old; all study drug is tablet for oral administration, taken once daily at bedtime. Placebo is a third treatment arm for comparison to the two active (suvorexant) treatment arms during the 3-month TRT Phase and, if applicable, the optional 3-month EXT Phase. During the 1-week DB RO following the TRT/EXT phase, participants in this study arm continue to receive placebo. During the 2-week single-blind Run-in period prior to randomization all participants receive placebo to suvorexant once daily at bedtime.
16238411|NCT01097590|Device|Active TLA Gut™ column|Five consecutive treatment sessions. The therapy will be administrated every second day.
16238412|NCT01097590|Device|Placebo|Five consecutive treatment sessions. The placebo therapy will be administrated every second day.
16238413|NCT01097577|Drug|pregabalin|1 capsule (75 mg) by mouth twice daily starting two hours prior to surgery and continuing 4 days postoperatively.
16238414|NCT01097577|Drug|Placebo|1 capsule by mouth twice daily starting two hours prior to surgery and continuing 4 days postoperatively.
16238415|NCT01097564|Genetic|COL4A1 genetic testing|genetic testing
16238416|NCT01097551|Drug|Trinitrin|Trinitrin: 2 sublingual pulverisations of 0.3 mg/dose
16238417|NCT01097551|Drug|Neosynephrine 10% collyrium|Neosynephrine 10% collyrium: 2 drops
16238418|NCT01097551|Drug|Iontophoresis with acetylcholine delivery|Iontophoresis with acetylcholine delivery
16238419|NCT01097551|Device|Dynamic Vessel Analyzer|Dynamic Vessel Analyzer
16238420|NCT01097538|Other|Body-weight supported treadmill training|Patients will undergo training using the Woodway Loco-system which consists of a treadmill with an overhead pulley system connected to a support harness. BWSTT allows patients with limited mobility to safely walk upright on a treadmill with a portion of their body weight counter balanced. Three trainers will be required to assist with the BWSTT program. Two trainers will be positioned at the lower limbs to manually guide the participant through a proper gait motion and provided lower limb control. A third trainer will stand behind the participant to provide trunk support and assist with weight shifting.
16238421|NCT01097538|Other|Total body recumbent stepper training|Patients will train using the Nustep T4 (TRS 4000) which is a recumbent cross trainer that provides a full body workout in a seated position. The Nustep trainer allows patients to achieve a natural stepping motion against graded loads with bilateral reciprocal movement of the arms. Recumbent training is safe and easily accessible for patients of all ability levels with a swivel chair to aid in patient transfers. Foot straps, leg stabilizers and hand stabilizers may be used for added control and proper body alignment.
16238422|NCT01097525|Procedure|WFG PRK|
16238423|NCT01097525|Procedure|WFG LASIK|
16238424|NCT01097525|Procedure|WFO PRK|
16238425|NCT01097525|Procedure|WFO LASIK|
16238426|NCT01097512|Drug|AS703569/gemcitabine|"Gemcitabine on Days 1 and 8, AS703569 on Days 2 and 9, of a 21-day cycle. The starting dose (DL1) for AS703569 will be 10mg/m2/day. The subsequent dose levels of AS703569 will follow the dose-escalation scheme with an approximate 50% increase from DL1 to DL2, 40% from DL2 to DL3, and thereafter an approximate increase of 33% from one dose level to the next.
~Gemcitabine will be administered at the dose of 1000mg/m2 once weekly during the first two weeks of each 21-day cycle."
16238484|NCT01097070|Drug|Bevirimat|
16238485|NCT01097057|Drug|Carboplatin|Given IV
16238486|NCT01097057|Drug|Etoposide|Given IV
16238487|NCT01097057|Biological|Filgrastim|Given SC
16238488|NCT01097057|Drug|Ifosfamide|Given IV
16238489|NCT01097057|Procedure|Leukapheresis|Given through catheter
16238427|NCT01097512|Drug|AS703569/gemcitabine|"AS703569 on Days 1 and 8, gemcitabine on Days 2 and 9, of a 21-day cycle. The starting dose (DL1) for AS703569 will be 10mg/m2/day. The subsequent dose levels of AS703569 will follow the dose-escalation scheme with an approximate 50% increase from DL1 to DL2, 40% from DL2 to DL3, and thereafter an approximate increase of 33% from one dose level to the next.
~Gemcitabine will be administered at the dose of 1000mg/m2 once weekly during the first two weeks of each 21-day cycle."
16238428|NCT01097499|Device|OsseoPulse device (Light emitting diode technology)|Patients in this group will be given the LED device and will be instructed on how and when to use it. They will receive LED treatment to the surgical site preoperatively by the surgeon for 20 minutes. Then, patients in this group will apply LED at home to the surgical site postoperatively at the day of surgery and for the following 9 postoperative days.
16238429|NCT01097486|Biological|NeoFuse|Single Dose NeoFuse Surgical Implantation
16238430|NCT01097486|Procedure|Allograft|Single Dose Allograft Surgical Implantation
16238431|NCT01097473|Procedure|Exercise training|Exercise training in outpatient sport groups once weekly with a duration of 60 min each
16238432|NCT01097460|Drug|MM-111 + Herceptin|For Phase 1: Dose escalation cohorts, MM-111 and Herceptin are administered weekly or bi-weekly via IV
16238433|NCT01097434|Device|Biodegradable polymer limus-eluting stents|due randomization biodegradable polymer limus-eluting stents will be implanted
16238434|NCT01097434|Device|Permanent polymer limus-eluting stent|due randomization permanent polymer limus-eluting stent will be implanted
16238435|NCT01097421|Drug|Pramipexole Extended Release|
16238436|NCT01097408|Drug|AZD7295|Up to 650mg AZD7295 capsules per dose. To be given 2 or 3 times daily for 5 days.
16238437|NCT01097408|Drug|Placebo comparator|Placebo capsules
16238438|NCT01097395|Drug|ribavirin|Randomization to standard weight based ribavirin dosing (1000 or 1200 mg daily) or concentration-guided dosing based on first dose AUC0-12
16238439|NCT01097382|Drug|ZOLPIDEM|Pharmaceutical form: tablet Route of administration: oral Dose regimen: once daily
16238440|NCT01097356|Dietary Supplement|probiotic drinkers|HPV+, LSIL patients in this arm will drink the probiotic study drink for a period of 6 months
16238441|NCT01097343|Drug|clopidogrel 75 mg|75 mg once daily
16238442|NCT01097343|Drug|Clopidogrel 150 mg|clopidogrel 150 mg
16238443|NCT01097330|Procedure|Ablation|Catheter based radiofrequency ablation for ischemic ventricular tachycardia scheduled to occur within 4 weeks after randomization
16238444|NCT01097330|Drug|Amiodarone|Amiodarone titrated to therapeutic levels as per standard of care and maintained on a dose of at least 200 mg (300 mg recommended) once a day for the duration of the study
16238445|NCT01097317|Drug|carboplatin|
16238446|NCT01097317|Drug|vinorelbine tartrate|
16238447|NCT01097317|Other|neuromuscular electrical stimulation|
16238448|NCT01097317|Other|physiologic testing|
16238449|NCT01097317|Procedure|fatigue assessment and management|
16238450|NCT01097317|Procedure|quality-of-life assessment|
16238451|NCT01097304|Drug|Ursodiol|Given PO
16238452|NCT01097304|Other|Laboratory Biomarker Analysis|Correlative studies
16238453|NCT01097278|Dietary Supplement|cholecalciferol|Given orally
16238454|NCT01097278|Other|placebo|Given orally
16238455|NCT01097265|Drug|capecitabine|
16238456|NCT01097265|Drug|oxaliplatin|
16238457|NCT01097265|Other|active surveillance|
16238458|NCT01097265|Other|laboratory biomarker analysis|
16238459|NCT01097265|Procedure|adjuvant therapy|
16238460|NCT01097265|Procedure|lymph node mapping|
16238461|NCT01097265|Procedure|sentinel lymph node biopsy|
16238462|NCT01097252|Radiation|radiation|radiation with cisplatin 40mg/m2, 6 cycles, every week
16238463|NCT01097252|Drug|weekly cisplatin|weekly cisplatin 40mg/m2, 6 cycles
16238464|NCT01097252|Drug|tri-weekly cisplatin|cisplatin 75mg/m2, 3cycles, every 3 weeks
16238465|NCT01097239|Device|Sonablate 500 (High Intensity Focused Ultrasound (HIFU))|High Intensity Focused Ultrasound (HIFU) Delivered by the Sonablate 500 Transrectal Device
16238466|NCT01097226|Other|Apple extract delivering 70 mg epicatechin|Delivered as a flavoured water based beverage
16238467|NCT01097226|Other|Apple extract delivering 140 mg epicatechin|Delivered as a flavoured water based beverage
16238468|NCT01097226|Other|Apple granules delivering 70 mg epicatechin|Delivered as a puree
16238469|NCT01097226|Other|Water delivering no epicatechin|Delivered as flavoured water
16238470|NCT01097213|Drug|Ethanol|Intravenous infusion of 6% ethanol in half-normal saline for approximately 1 hour: The dosage is controlled by a physiologically-based pharmacokinetic (PBPK) model of alcohol distribution and elimination, developed by O'Connor and his associates at the Indiana Alcohol Research Center (IARC) (Ramchandani et al, 1999). PBPK Parameters that determine the dosage and frequency of the infusion for a specific individual are estimated by means of morphometric variables (age, height, weight and gender).
16238471|NCT01097213|Drug|Placebo - half-normal saline|Intravenous infusion of half-normal saline for approximately 1 hour: The dosage is equal to the infusion dosage estimated by the PBPK model of alcohol distribution and elimination (Ramchandani et al., 1999) for the drug - ethanol condition.
16238472|NCT01097200|Device|Elevate mesh|The correction of the prolapse can be made by this new technique.
16238473|NCT01097200|Device|Sacrocolpopexy|Attach a mesh between the vagina and the promontorium.
16238474|NCT01097174|Device|CyPass Micro-Stent|The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front into the back of they eye.
16238475|NCT01097161|Behavioral|speech therapy with the assistance of an acoustical analysis program|Two weekly speech sessions realized on individual basis for three months period
16238476|NCT01097148|Drug|Atracurium, TBW|Dose atracurium 0.5 mg/kg based on total body weight
16238477|NCT01097135|Drug|Duraprep Surgical Solution|
16238478|NCT01097122|Procedure|Forearm vibration|Mechanical loading with forearm vibration will be applied right radius in all groups
16238479|NCT01097096|Biological|CAD106|150μg and 450μg doses were reconstituted and administered via intramuscular injection
16238480|NCT01097096|Biological|Placebo|Identical placebo to CAD106 administered via intramuscular injection
16238490|NCT01097057|Drug|Plerixafor|Given SC
16238491|NCT01097057|Biological|Rituximab|Given IV
16238492|NCT01097044|Drug|Afamelanotide|One 16mg subcutaneous implant every 2 months for 6 months. (3 implants in total)
16238493|NCT01097044|Drug|Placebo|One placebo subcutaneous implant every 2 months for 6 months. (3 implants in total)
16238494|NCT01097031|Other|Infusion Intermittent|
16238495|NCT01097018|Drug|Capecitabine|1000 mg/m2 BID/ Days 1-14
16238496|NCT01097018|Drug|Perifosine|50 mg daily x 21 days
16238497|NCT01097018|Drug|Placebo|1 pill daily x 21 days
16238498|NCT01096992|Drug|Bendamustine|"Phase 1: Starting Dose of 20 mg/m2 IV on Days 1,2,3 (after fludarabine)
~Phase 2: 30 mg/m2 by vein (fixed) on Days 1,2,3 (after fludarabine)"
16238499|NCT01096992|Drug|Fludarabine|Course 1: 20 mg/m2 intravenous (IV) on Days 2,3,4 Courses 2-6: 20 mg/m2 IV, Days 1,2,3
16238500|NCT01096992|Drug|Rituximab|Course 1: 375 mg/m2 IV, Day 4 (after fludarabine) Courses 2-6: 500 mg/m2 IV, Day 1
16238501|NCT01096979|Drug|LIPO-102|subcutaneous injection
16238502|NCT01096979|Drug|Placebo|Placebo
16238503|NCT01096966|Drug|Bupivacaine TTS (Bupivacaine Patch)|Contains bupivacaine base, in a flexible and rectangular-shaped, transdermal, delivery system. Three patches applied to the lower back every 72 hours for 12 weeks.
16238504|NCT01096966|Drug|Placebo patch|Identical in size and shape to the Bupivacaine Patch. Three patches applied to the lower back every 72 hours for 12 weeks.
16238505|NCT01096953|Behavioral|Mental health care implemented by telepsychiatry|Care of 6-17 year-olds with ADHD
16238506|NCT01096953|Behavioral|Face-to-face care|Psychiatry provided for treatment of ADHD face-to-face in office
16238507|NCT01096940|Drug|AZD1656|Oral tablet, BID dose
16238508|NCT01096940|Drug|simvastatin|Oral tablet, single dose
16238509|NCT01096927|Drug|Amoxicillin and Clavulanic Acid|7 days antibiotic therapy with Amoxicillin and Clavulanic Acid, 1 gr 3 times daily PO
16238510|NCT01096914|Procedure|percutaneous radiofrequency ablation|"Procedure: Radiofrequency ablation For RFA, we used a commercially available system (Valleylab, Tyco Healthcare, Boulder, CO, USA) and a 17-gauge cool-tip needle electrode with a 3cm exposed tip. The needle is inserted percutaneously under ultrasound guidance in the HCC nodule and treatment lasts 12 minutes. For nodules larger than 3cm in diameter, 2 insertions are used. In a period of six months, treatment may be repeated for no more than three times. When, after treatment, CT or MRI show a residual nodule activity of 10% or less, percutaneous ethanol injection may be done. If the residual activity is of 50% or more transarterial chemoembolization may be used."
16238511|NCT01096914|Procedure|percutaneous laser ablation|Procedure: Laser ablation For LA, we used a commercially available system (Echolaser XVG system, Esaote El.En., Florence, Italy) and four optical fibers,inserted into the cancer through four 21-gauge needles. The treatment lasts 6 minutes. For nodules larger than 3 cm in diameter, two treatments are done. In a period of six months, treatment may be repeated for no more than three times. When, after treatment, CT or MRI show a residual nodule activity of 10% or less, percutaneous ethanol injection may be done. If the residual activity is of 50% or more transarterial chemoembolization may be used.
16238512|NCT01096901|Behavioral|Behavioral Weight loss|Intervention groups will meet weekly for 12 weeks. Weekly meetings will focus on weight loss in women age 30-45 through behavioral weight loss topics. These topics are designed with the Look AHEAD protocols.
16238513|NCT01096888|Behavioral|Enhanced WIC Program|Applying an internet based weight loss intervention to participants in the WIC program to enhance weight loss post partum.
16238514|NCT01096875|Drug|Atorvastatin|40mg/day once daily for two weeks prior to surgery
16238515|NCT01096875|Drug|Placebo|1tb/day once daily for two weeks prior to surgery
16238516|NCT01096862|Drug|peficitinib|oral
16238517|NCT01096862|Drug|Placebo|oral
16238518|NCT01096849|Drug|levofloxacin|
16238519|NCT01096849|Drug|plazomicin|
16238520|NCT01096849|Drug|placebo|
16238521|NCT01096836|Other|macronutrient and energy manipulation|
16238522|NCT01096823|Behavioral|Iyengar Yoga|Iyengar Yoga classes twice a week for six weeks
16238523|NCT01096810|Drug|TBL 12|TBL 12 will be administered orally at a dose of 2 units (20 mL each) twice a day until disease progression.
16238524|NCT01096797|Drug|Sevoflurane|"Anaesthesia induction: sevoflurane 4 to 6% by mask and IV propofol 2-6 mg/kg.
~Anaesthesia maintenance: sevoflurane 2-3 %
~Intraoperative and postoperative analgesia: IV fentanyl 1,5-2,5 mcg/kg, IV paracetamol 15 mg/kg
~Prevention of postoperative nausea and vomiting: dexamethasone 0,1 mg/kg, ondansetron 0,1 mg/kg"
16238525|NCT01096784|Drug|rhIGF-I/rhIGFBP-3|Continuous intravenous infusion
16238526|NCT01096771|Drug|ClinOleic 20%|96 hour continuous infusion.
16238527|NCT01096771|Drug|Intralipid 20%|96 hour continuous infusion.
16238528|NCT01096745|Drug|Gemcitabine, Cisplatin|D1,D8 Gemcitabine 1000mg/m2 + N/S 150cc miv over 30mins D1,D8 Cisplatin 25/m2 + N/S 150cc miv over 60mins repeated every 3weeks
16238529|NCT01096745|Drug|S-1, Cisplatin|D1-14 S-1 40mg/m2 po bid D1,D8 Cisplatin 25/m2 + N/S 150cc miv over 60mins Repeated every 3 weeks
16238530|NCT01096732|Drug|GDC-0449|Gelatine capsules of 150mg.Taken O.D. for 14 days.
16238531|NCT01096719|Behavioral|Standard Behavioral Weight Loss Intervention|12 week standard behavioral weight loss intervention including a physical activity goal and behavioral weight control strategies
16238532|NCT01096719|Behavioral|Dietary Goal: Reduction in Energy Density of Dietary Intake|Consume low ED foods (ED < 1.0) for at least 10 items consumed per day and limit high ED foods (ED > 3.0) to two items consumed per day.
16238533|NCT01096719|Behavioral|Dietary Goal: Reduction of Energy Intake|Limit energy intake to 1200 to 1500 kcals/day and < 30% kcals from fat.
16238534|NCT01096706|Drug|NO clamp|"After a 20 minute saline washout period, ascending doses of Urocortin 2, Urocortin 3 and substance P (doses as per Protocol 2) will be infused intra-arterially in the presence or the absence of the 'nitric oxide clamp' that will be commenced prior to the infusion of Urocortin 2, Urocortin 3 and substance P, and will be continued throughout the study.
~Baseline blood samples will be taken from both forearms at the start of the study for full blood count, cholesterol, glucose, renal function and t-PA and PAI-1 activity and antigen concentrations. Bilateral venous blood samples will be taken at baseline, immediately before the start of Ucn2/Ucn3 infusion and at the end of each dose of Ucn2/Ucn3 for subsequent calculation of net release of t-PA and PAI-1."
16238647|NCT01096056|Biological|Fluarix|Intramuscular administration, 1 dose
16238815|NCT01094782|Other|Acupuncture|Subjects receive 6 acupuncture treatments for neck or back pain.
16238535|NCT01096706|Drug|Saline|"After a 20 minute saline washout, incremental doses of Urocortin 2, Urocortin 3 and Substance P (in doses as per Protocol 2) will be infused in the presence of saline placebo.
~Baseline blood samples will be taken from both forearms at the start of the study for full blood count, cholesterol, glucose, renal function and t-PA and PAI-1 activity and antigen concentrations. Bilateral venous blood samples will be taken at baseline, immediately before the start of Ucn2/Ucn3 infusion and at the end of each dose of Ucn2/Ucn3 for subsequent calculation of net release of t-PA and PAI-1."
16238536|NCT01096706|Drug|Fluconazole|"After a 20 minute saline washout period, ascending doses of Urocortin 2, Urocortin 3 and substance P (doses as per Protocol 2) will be infused intra-arterially in the presence of Fluconazole (which serves to inhibit the EDHF pathway) that will be commenced prior to the infusion of Urocortin 2, Urocortin 3 and substance P, and will be continued throughout the study.
~Baseline blood samples will be taken from both forearms at the start of the study for full blood count, cholesterol, glucose, renal function, plasma Ucn 2 and 3 and t-PA and PAI-1 activity and antigen concentrations. Bilateral venous blood samples will be taken at after the top dose of Ucn2/Ucn3 infusion and before and after each dose of Substance P for subsequent calculation of plasma Ucn 2/ Ucn 3 and net release of t-PA and PAI-1."
16238537|NCT01096706|Drug|Aspirin|"Oral Aspirin (600mg stat) will be administered 30 minutes before start of the study. After a 20 minute saline washout period, ascending doses of Urocortin 2, Urocortin 3 and substance P (doses as per Protocol 2) will be infused intra-arterially in the presence of saline.
~Baseline blood samples will be taken from both forearms at the start of the study for full blood count, cholesterol, glucose, renal function, plasma Ucn 2 and 3 and t-PA and PAI-1 activity and antigen concentrations. Bilateral venous blood samples will be taken at after the top dose of Ucn2/Ucn3 infusion and before and after each dose of Substance P for subsequent calculation of plasma Ucn 2/ Ucn 3 and net release of t-PA and PAI-1."
16238538|NCT01096706|Drug|Combined|"Oral Aspirin (600mg stat) is administered 30 minutes before start of the study. After a 20 minute saline washout period, ascending doses of Urocortin 2, Urocortin 3 and substance P (doses as per Protocol 2) will be infused intra-arterially in the presence of the 'nitric oxide clamp' that will be commenced prior to the infusion of Urocortin 2, Urocortin 3 and substance P, and will be continued throughout the study. Intra-arterial Fluconazole is also commenced at the time of the Nitric oxide clamp.
~This serves to inhibit the cyclooxygenase, EDHF and NO pathways of endothelial vasodilatation.
~Blood samples are taken as per previous arms."
16238539|NCT01096693|Drug|Urocortin 2, Urocortin 3|"After a 20 minute infusion of intra arterial saline, healthy volunteers will receive ascending doses of intra arterial Urocortin 2 (3.4, 34 and 340 pmol/min to achieve estimated end-organ concentrations of 0.06, 0.6 and 6 µg/L, respectively), Urocortin 3 (3.4, 34 and 340 pmol/min to achieve estimated end-organ concentrations of 0.06, 0.6 and 6 µg/L, respectively) and Substance P (a control endothelium-dependent vasodilator that evokes endogenous t-PA release [2, 4 and 8 pmol/min]). This will be co-infused with either Astressin 2B (in one of the two doses determined from Protocol 1) or saline placebo.
~Bilateral venous blood sampling will be performed at baseline, immediately before the start and after each dose of Urocortin 2 and 3, to later estimate net release of tPA and PAI-1 and for plasma measurements of Urocortins 2 and 3."
16238540|NCT01096693|Drug|Saline placebo|"After 20 minutes of intra arterial saline infusion, incremental doses of Urocortin 2, 3 and Substance P will be administered (in doses similar to Active comparator arm), co infused with saline placebo.
~Bilateral venous blood samples will be taken at baseline, immediately before the start of Ucn2/Ucn3 infusion and at the end of each dose of Ucn2/Ucn3 for subsequent calculation of net release of t-PA and PAI-1."
16238541|NCT01096680|Drug|SPD489 20 mg|Single oral dose of 20 mg
16238542|NCT01096680|Drug|SPD489 50 mg|Single oral dose of 50 mg
16238543|NCT01096680|Drug|SPD489 70 mg|Single oral dose of 70 mg
16238544|NCT01096680|Drug|Armodafinil|Single oral dose of 250 mg
16238545|NCT01096680|Drug|Placebo|Single oral dose
16238546|NCT01096667|Drug|Placebo to Ertuglilflozin 1 or 5 mg|Placebo to ertuglilflozin tablet 1 or 5 mg once daily for 28 days
16238547|NCT01096667|Drug|Ertugliflozin 1 mg|Ertugliflozin tablet 1 mg once daily for 28 days
16238548|NCT01096667|Drug|Ertugliflozin 5 mg|Ertugliflozin tablet 5 mg once daily for 28 days
16238549|NCT01096667|Drug|Ertugliflozin 25 mg|Ertugliflozin tablet 25 mg once daily for 28 days
16238550|NCT01096667|Drug|HCTZ 12.5mg|Hydrocholorthiazide (HCTZ) 12.5 mg capsule once daily for 28 days
16238551|NCT01096667|Drug|Placebo to HCTZ|Placebo to HCTZ 12.5 mg capsule once daily for 28 days
16238552|NCT01096667|Drug|Placebo to ertuglilflozin 25 mg|Placebo to ertuglilflozin tablet 25 mg once daily for 28 days
16238553|NCT01096654|Other|Ct-scan or adrenal vein sampling|Patients will be randomized to undergo either adrenal CT-scanning or AVS (with pre-AVS adrenal CT-scanning for phlebography). The result of either of these tests will determine the course of action: adrenalectomy for adenoma or MRAs for bilateral hyperplasia.
16238554|NCT01096641|Behavioral|immediate CBT|After the baseline assessment the fatigued patients will be randomized to start immediately with Cognitive Behaviour Therapy, especially designed for fatigued cancer patients
16238555|NCT01096641|Behavioral|Delayed CBT|After the baseline assessment the fatigued patients will be randomized: this group is to be placed on a waiting list. After 6 months, a second assessment will take place in the group of fatigued patients who received CBT immediately after randomization. This assessment will include the same measurements as at baseline. The fatigued patients on the waiting list will then start with CBT.
16238556|NCT01096628|Other|Chiropractic + Exercise|"Treatment will include eight to 16 treatments provided over the 12-week period. Each treatment visit will last from 10-20 minutes and consist of manual spinal manipulation and mobilization. Light soft tissue techniques (i.e., active and passive muscle stretching, hot and cold packs, and ischemic compression of tender points) will be used as indicated to facilitate the manual therapy.
~Patients will attend 8 to 16, one-on-one, 45-minute sessions over the course of 3 months. The sessions will follow a standardized approach but will be individualized to meet the patient's needs specific to their lifestyle, fitness level, and clinical characteristics. The exercise program will be comprised of three parts: 1) education, 2) supervised exercise, and 3) home exercise."
16238557|NCT01096628|Other|Exercise|Patients will attend 8 to 16, one-on-one, 45-minute sessions over the course of 3 months. The sessions will follow a standardized approach but will be individualized to meet the patient's needs specific to their lifestyle, fitness level, and clinical characteristics. The exercise program will be comprised of three parts: 1) education, 2) supervised exercise, and 3) home exercise.
16238558|NCT01096615|Dietary Supplement|Placebo|"Description:
~- capsule size 3
~Composition of the product:
~45 mg of microcristalline cellulose,
~132 mg of maltodextrin,
~3 mg of magnesium stearate.
~Composition of the capsule:
~46 mg of hypromellose,
~1 mg of titanium dioxide.
~Packaging:
~Products are packaged in aluminium tubes of 30 capsules.
~Storage:
~The product should be stored in a fridge. Direction for use: subject should consume 1 capsule daily together with a meal, with a glass of water.
~The study products will be consumed daily for 7 weeks."
16238559|NCT01096615|Dietary Supplement|Lactobacillus paracasei LP-33|"Description:
~minimum 2.0x109 CFU of Lactobacillus paracasei LP-33
~capsule size 3 1 capsule daily together with a meal, with a glass of water."
16238560|NCT01096602|Biological|DC AML Vaccine|Group 1: 2-3 doses of the vaccine at 4 week intervals
16238561|NCT01096589|Device|3M Coban 2 (Compression System)|Nonwoven cohesive backing and foam.
16238562|NCT01096589|Device|3M Coban 2 (Compression System)|Nonwoven cohesive backing and foam.
16238563|NCT01096589|Device|3M Coban 2 (Compression System)|Nonwoven cohesive backing and foam.
16238564|NCT01096589|Device|Comprilan|Commercial short-stretch bandage (Comprilan; BSN Medical Ltd, Hull, U.K).
16238565|NCT01096576|Drug|balapiravir [RO4588161]|sequential cohorts receiving doses orally twice daily for 5 days
16238566|NCT01096576|Drug|placebo|orally twice daily for 5 days
16238567|NCT01096563|Drug|AZD9164|"Dry powder for inhalation via Turbuhaler, JSMAD. A single dose of AZD9164 on Day 1 and repeated dosing on Day 4 to day 15 (JSMAD).
~The starting dose will be 400 μg delivered dose and subsequent doses are planned to be 1000 μg and 2800 μg delivered dose."
16238568|NCT01096563|Drug|Placebo|Dry powder for inhalation via Turbuhaler, JSMAD.
16238569|NCT01096550|Behavioral|Outpatient|Buprenorphine patients receiving 2 to 8 hours of outpatient counseling.
16238570|NCT01096550|Behavioral|Intensive Outpatient|Buprenorphine patients receiving 9 or more hours of outpatient counseling.
16238571|NCT01096524|Other|Standard Physiotherapy|The Control group will complete the standard physiotherapy care pre and post-TKA surgery without NMES.
16238572|NCT01096524|Device|Kneehab|"NMES 2 x 20 minute sessions/day, 5 days/week, 6 weeks pre and 6 weeks post TKA.
~Kneehab™ (Bio-Medical Research, Ltd., Galway, Ireland) is a NMES device with Multipath™ technology, designed to activate the quadriceps muscle. Kneehab™ is a battery operated, portable, 2-channel cutaneous electrical muscle stimulator, which operates using constant current pulses to stimulate the nerves innervating the quadriceps muscle. Kneehab™, consists of a thigh wrap with anatomically shaped electrodes and a control unit. Electrodes are placed over the quadriceps muscles and the garment is wrapped around the leg above the knee. Brief electrical impulses are delivered through the skin surface adhesive electrodes."
16238573|NCT01096511|Drug|Moxifloxacin (Avelox, BAY12-8039)|The treatment with Moxifloxacin 400 mg infusion should comply with the recommendations written in the local product information. The decision about the treatment with Moxifloxacin as well as the duration of treatment is solely up to the attending physician.
16238574|NCT01096498|Drug|Levonorgestrel Emergency Pill (BAY86-5028/Opxion)|Single dose of one 0.75 mg coated tablet
16238575|NCT01096498|Drug|Levonorgestrel (Postday)|Single dose of one 0.75 mg tablet
16238576|NCT01096485|Drug|Levonorgestrel Emergency Pill (BAY86-5028/Opxion)|Single dose of 1.5 mg coated tablet
16238577|NCT01096485|Drug|Levonorgestrel (Postday)|Single dose of two 0.75 mg tablets
16238578|NCT01096472|Drug|LAS41003|Once daily
16238579|NCT01096472|Drug|LAS189961|Once daily
16238580|NCT01096472|Drug|LAS189962|Once daily
16238581|NCT01096459|Procedure|Nerve Rerouting|All subjects will receive the unilateral nerve rerouting procedure.
16238582|NCT01096446|Drug|Intravenous Fat Emulsions|Control Group: 0.5 grams/kg/day Experimental Group: 2 grams/kg/day
16238583|NCT01096433|Device|CPAP treatment|maintains upper airway patency and minimizes the obstructive events
16238584|NCT01096420|Procedure|acupuncture|"Each patient had a fixed and classic acupuncture points Ex-HN-3,BL-2,GB-20,EX-HN-5 bilaterally in their 24 sessions.
~Acupuncture consisted of 24 sessions of 30 min duration, administrated over 12 weeks (two sessions per week).
~Sterile disposable and steel needle (3210) were used .
~The needles were manipulated by rotation methods to produce a characteristic sensation know as De Qi."
16238585|NCT01096420|Drug|topiramate|"The patients were submitted to the topiramate treatment also for 12 consecutive weeks.
~The study phase consists of a 4-week titration and a 8-week maintenance period.
~All dosages of topiramate will be initiated at 25 mg/d hs and increased by 25 mg/d weekly to a maximum of 100 mg/day (or to the maximal tolerated dose).
~Study drug was administered daily in equally divided twice daily doses."
16238586|NCT01096407|Other|laboratory biomarker analysis|Collection of urine samples
16238587|NCT01096407|Other|questionnaire administration|Completion of questionnaires
16238588|NCT01096407|Procedure|assessment of therapy complications|An assessment will be completed.
16238589|NCT01096381|Other|laboratory biomarker analysis|Blood collection
16238590|NCT01096381|Other|questionnaire administration|Survey regarding baseline health and activity level.
16238591|NCT01096368|Radiation|3-Dimensional Conformal Radiation Therapy|Patients undergo conformal radiotherapy
16238592|NCT01096368|Drug|Carboplatin|Given IV
16238593|NCT01096368|Drug|Cisplatin|Given IV
16238594|NCT01096368|Other|Clinical Observation|Patients undergo observation
16238595|NCT01096368|Drug|Cyclophosphamide|Given IV
16238596|NCT01096368|Drug|Etoposide|Given IV
16238597|NCT01096368|Other|Laboratory Biomarker Analysis|Optional correlative studies
16238598|NCT01096368|Drug|Vincristine|Given IV
16238599|NCT01096355|Drug|gamma-secretase/Notch signalling pathway inhibitor RO4929097|
16238600|NCT01096355|Other|diagnostic laboratory biomarker analysis|
16238601|NCT01096355|Other|pharmacogenomic studies|
16238602|NCT01096355|Other|pharmacological study|
16238603|NCT01096342|Drug|dinaciclib|Given IV
16238604|NCT01096342|Other|laboratory biomarker analysis|Correlative studies
16238605|NCT01096329|Drug|Testosterone Spray 5% and 1%|Testosterone Spray 5% 2x90uL for 14 days Testosterone Spray 1% 2x90uL for 14 days
16238606|NCT01096329|Drug|Intrinsa® Patch and Testosterone Spray 5%|Testosterone Spray 5% 2x90uL for 14 days Intrinsa® Patch for 14 days
16238607|NCT01096329|Drug|Intrinsa® Patch and Testosterone Spray 1%|Testosterone Spray 1% 2x90uL for 14 days Intrinsa® Patch for 14 days
16238608|NCT01096316|Behavioral|Depression Care Management|The intervention is conducted by a social worker who has the role of a Depression Care Manager (DCM). First, a unique engagement session develops rapport with the DCM, providing education and identifying health concerns. DCM meets in-person and/or by phone every 1-2 weeks for 12 weeks, then monthly for the rest of the 12-month intervention. Patients choose either medication or Problem-Solving Treatment-Primary Care therapy. Depressive symptoms are assessed at each visit with the PHQ-9, as well as response to medications or to PST, with a total of 8 PST-PC sessions. Patients with inadequate response after 8 weeks to the first choice will switch or combine treatments. Providers are given extensive feedback about the patient's health care concerns.
16238609|NCT01096290|Drug|lubiprostone|24mcg BID, capsule, oral 30days
16238610|NCT01096290|Drug|Matched placebo|Twice daily for 30days, oral
16238611|NCT01096277|Drug|Sitagliptin|oral tablets 100 mg per day for two weeks
16238612|NCT01096277|Drug|Placebo|oral tablet, one per day for two weeks
16238613|NCT01096277|Other|Control|no intervention
16238614|NCT01096264|Other|SSI and SphygmoCor® evaluations|"SSI evaluation need Aixplorer vascular ultrasound machine (available in our department) with 8 MHz linear array probe applied on the carotid and femoral artery.
~SphygmoCor® evaluation used pressure captors on carotid and femoral sites to record the intra-arterial pressure wave time delay after QRS wave. After distance calculation between the two sites, Aortic PWV can be derived."
16238615|NCT01096251|Behavioral|CBT vs BST|The comparison between the CBT and BST will be assessed in a two-arm randomized controlled trial. Participants will be randomly allocated in 2 groups (CBT and BST).
16238616|NCT01096225|Biological|split-virion, H1N1 vaccine of 15 μg|split-virion inactivated S-OIV vaccine of 15 μg on day 0 and 21.
16238617|NCT01096212|Drug|original sevoflurane|Sevoflurane content: 99.9985%, compound A: 4.6 ppm, water content (sample was opened, sealed and stored for 2 weeks): 0.072% w/v
16238618|NCT01096212|Drug|generic sevoflurane|Sevoflurane content: 99.99%, compound A: 3.8 ppm, water content (sample was opened, sealed and stored for 2 weeks) : 0.044% w/v
16238619|NCT01096199|Drug|TS-ONE, Cisplatin, RAD001|
16238620|NCT01096186|Drug|IPX066 95 mg|23.75 - 95 mg CD-LD capsules
16238621|NCT01096186|Drug|IPX066 145 mg|36.25 - 145 mg CD-LD capsules
16238622|NCT01096186|Drug|IPX066 195 mg|48.75 - 195 mg CD-LD capsules
16238623|NCT01096186|Drug|IPX066 245 mg|61.25 - 245 mg CD-LD capsules
16238624|NCT01096160|Drug|MK-8226 BID, 1 mg|MK-8266 1 mg administered as oral capsules (0.7 mg + 0.3 mg), BID for 10 consecutive days. Panel A was completed prior to initiation of Panel B.
16238625|NCT01096160|Drug|MK-8266 BID, 1.8 mg|MK-8266 1.8 mg administered as oral capsules (1 mg + 0.8 mg), BID for 10 consecutive days. Panel B was completed prior to initiation of Panel C.
16238626|NCT01096160|Drug|MK-8266 TID, 1.8 mg|MK-8266 1.8 mg administered as oral capsules (0.6 mg), TID for 10 consecutive days. Panel C was completed prior to initiation of Panel D.
16238627|NCT01096160|Drug|MK-8266 TID, 2.4 mg|MK-8266 TID (Panel D), 2.4 mg administered as oral capsules (0.8 mg), TID for 10 consecutive days. Panel D was completed prior to initiation of Panel E.
16238628|NCT01096160|Drug|MK-8266 TID, 2.4 mg|MK-8266 TID (Panel E), 2.4 mg administered as oral capsules (0.8 mg), TID for 10 consecutive days. Panel E was initiated after completion of Panel D.
16238629|NCT01096160|Drug|Placebo BID (Panel A)|Placebo administered as oral capsules BID for 10 consecutive days. Panel A was completed prior to initiation of Panel B.
16238630|NCT01096160|Drug|Placebo BID (Panel B)|Placebo administered as oral capsules BID for 10 consecutive days. Panel B was completed prior to initiation of Panel C.
16238631|NCT01096160|Drug|Placebo TID (Panel C)|Placebo administered as oral capsules TID for 10 consecutive days. Panel C was completed prior to initiation of Panel D.
16238632|NCT01096160|Drug|Placebo TID (Panel D)|Placebo administered as oral capsules TID for 10 consecutive days. Panel D was completed prior to initiation of Panel E.
16238633|NCT01096160|Drug|Placebo TID (Panel E)|Placebo administered as oral capsules TID for 10 consecutive days. Panel E was initiated after completion of Panel D.
16238634|NCT01096147|Device|Spinal cord stimulation with eight polar electrode|In SCS a lead is positioned in the epidural space on the dorsal aspect of the spinal cord as to produce electrically induced paraesthesia in the painful area.
16238635|NCT01096134|Biological|HPV Vaccine (Gardasil)|"HPV Vaccine Administration: According to the CDC, Gardasil should be delivered through a series of three intra-muscular injections over a six-month period. The second and third doses should be given two and six months after the first dose. The vaccine can be administered at the same visit as other age-appropriate vaccines, such as Tdap, Td, MCV4, influenza, and hepatitis B vaccines. Providers should consider a 15-minute waiting period for vaccine recipients following vaccination.
~FDA's Approval of Gardasil (June 8, 2006) lists the following information on product Formulation: Each 0.5 mL dose of the vaccine contains:
~20 mcg of HPV 6 L1 protein 40 mcg of HPV 11 L1 protein 40 mcg of HPV 16 L1 protein 20 mcg of HPV 18 L1 protein 225 mcg aluminum (as amorphous aluminum hydroxyphosphate sulfate adjuvant) 9.56 mg of sodium chloride 0.78 mg of L-histidine 50 mcg of polysorbate 80 35 mcg of sodium borate water for injection"
16238636|NCT01096121|Drug|Enalapril|"during 1 month : 0,2 mg/kg/day
~then during 2 months (if no adverse event): 0,35 mg/kg/day
~and then during 6 months (if no adverse event): 0,5 mg/kg/day"
16238637|NCT01096121|Drug|Placebo|Glucose
16238638|NCT01096108|Behavioral|Standard contest (1 month)|Smoking abstinence, 1 prize award (month 1)
16238639|NCT01096108|Behavioral|Motivational and Problem-Solving|Counseling phone calls
16238640|NCT01096108|Behavioral|Extended Contests|Smoking abstinence, 3 contest prize awards (contests 1, 2 and 3)
16238641|NCT01096095|Drug|Placebo|Powdered placebo in sachets containing each 3g. At the start of the study, the dose will be 15g/day (five sachets).
16238642|NCT01096095|Drug|Sodium Phenylbutyrate|Powdered sodium phenylbutyrate in sachets containing each 3g. At the start of the study, the dose will be 15g/day (five sachets) and may be reduced in case of mild adverse events.
16238643|NCT01096082|Drug|Lithium Carbonate|300 mg tablets, starting dose 300 mg/day
16238644|NCT01096082|Drug|Placebo|Similar shape, color and taste and the same number of tablets from the experimental group
16238645|NCT01096056|Biological|Influenza vaccine GSK2186877A formulation 1|Intramuscular administration, 2 doses
16238646|NCT01096056|Biological|Influenza vaccine GSK2186877A formulation 2|Intramuscular administration, 1 dose
16238648|NCT01096043|Drug|Placebo|An infusion of an identically appearing solution of sugar water will be intravenously administered.
16238649|NCT01096043|Drug|Strata 1 CXL-1020|Intravenous infusion of CXL-1020, up-titrated, so that 3 different dosages are administered over 6 hours
16238650|NCT01096043|Drug|Strata 2 CXL-1020|One of 3 different dosages of CXL-1020 administered at a fixed dosage level for 6 hours.
16238651|NCT01096043|Drug|Strata 3 CXL-1020|A fixed dose level of CXL-1020 will be administered for the initial 6 hours of treatment in Strata 3 and then dosage will be altered up or downward based on the investigators observation of the patient's condition.
16238652|NCT01096030|Drug|Regorafenib (Stivarga, BAY73-4506)|160 mg oral once daily BAY 73-4506 for 3 weeks of every 4 week cycle (i.e. 3 weeks on, 1 week off)
16238653|NCT01096017|Drug|Terbutaline Turbuhaler®|0.4 mg, inhalation, single dose
16238654|NCT01096017|Drug|Salbutamol pMDI|200 μg, inhalation, single dose
16238655|NCT01096017|Other|pMDI placebo pMDI|Placebo pMDI 2 inhalations
16238656|NCT01096017|Other|Placebo Turbuhaler®|Placebo Turbuhaler 1 inhalation
16238657|NCT01096004|Drug|AZD4017|oral suspension, 1200mg, once daily, for 10 days
16238658|NCT01096004|Drug|Placebo|
16238659|NCT01095991|Drug|AZD1656|Oral tablet bd,
16238660|NCT01095991|Drug|Sitagliptin|Oral tablet od
16238661|NCT01095978|Drug|Clarithromycin (Klacid SR)|Klacid SR in a dose of 1000 mg once daily
16238662|NCT01095965|Behavioral|Nutrition education|Group education on a bi-weekly basis for eight weeks plus written education materials, followed by monthly group problem solving meetings till one year.
16238663|NCT01095952|Device|AVNS ON|Delaying the AV-node by stimulating the parasympathetic nerves innervating the AV-node with high frequency burst pacing during the refractory period of the ventricle using a standard atrial lead at a septal position.
16238664|NCT01095939|Drug|Placebo|Tablets; oral administration; once a day for 6 months. After this period of 6 months blinded treatment, the treatment will be stopped for 2 weeks. At the end of this washout period, a new renal evaluation is done. At that time, opened label treatment will be proposed to the women who still show renal alterations after a 2 weeks washout period
16238665|NCT01095939|Drug|Benazepril hydrochloride|Tablets (10 or 20 mg); oral administration; once a day for 6 months. After this period of 6 months blinded treatment, the treatment will be stopped for 2 weeks. At the end of this washout period, a new renal evaluation is done. At that time, opened label treatment will be proposed to the women who still show renal alterations after a 2 weeks washout period
16238666|NCT01095926|Drug|doxorubicin|blood sampling before, during and after doxorubicin administration
16238667|NCT01095913|Drug|Indocyanine green (ICG)|Injections performed after induction of anesthesia for surgery; 25 µg ICG/injection, with injections of 0.1 cc each to be made starting in the hand, arm, and areolar regions of the breast.
16238668|NCT01095900|Procedure|conservative lateral internal sphincterotomy|
16238669|NCT01095900|Procedure|Intra-sphincteric Botulinum-toxin injection|
16238670|NCT01095887|Drug|Eculizumab|Subjects received eculizumab intravenously at the time of transplant, on the day after transplant, then weekly for four weeks. At four weeks post transplant, anti-blood group antibody levels were determined. Subjects may have potentially received eculizumab every two weeks for one year depending on antibody levels.
16238671|NCT01095861|Device|FlexTip ETT (Parker FlexTip/GlideScope FlexTip)|FlexTip ETT used for endotracheal intubation
16238672|NCT01095861|Device|Control - standard flexible ETT (Mallinckrodt)|"Control - standard flexible ETT
~Mallinckrodt Hi-Lo cuffed tracheal tube, Catalog # 86114, Mallinckrodt, ST. Louis, MO, 63134"
16238673|NCT01095848|Biological|DPX-0907 consists of 7 tumor-specific HLA-A2-restricted peptides, a universal T Helper peptide, a polynucleotide adjuvant, a liposome and Montanide ISA51 VG|Patients will receive three deep subcutaneous injections of the vaccine three weeks apart in the upper thigh region. Patients will be followed for up to 7 months.
16238674|NCT01095835|Drug|Pegylated interferon (PEG-IFN) alfa-2a, 180 mcg|PEG-IFN alfa-2a 180 micrograms (mcg) was administered subcutaneously, once weekly from Week 0 to 48.
16238675|NCT01095835|Drug|Pegylated interferon (PEG-IFN) alfa-2a, 135 mcg|PEG-IFN alfa-2a 135 mcg was administered subcutaneously, once weekly from Week 49 to 96.
16238676|NCT01095835|Drug|Lamivudine (LAM)|Lamivudine 100 milligrams (mg) was administered orally, daily from Week 0 to 48.
16238677|NCT01095822|Drug|Aliskiren + Valsartan|Comparison of combination (aliskiren + valsartan) therapy versus valsartan alone on hemostatic indices
16238678|NCT01095809|Drug|bevacizumab|2.5mg at baseline, week 4 and 8. Beyond this initial period if needed reinjection criteria are described in protocol
16238679|NCT01095809|Drug|triamcinolone acetonide|2 mg at baseline; frequency every three months if needed. reinjection criteria are described in protocol
16238680|NCT01095796|Drug|Stribild|Stribild (EVG 150 mg/COBI 150 mg/FTC 200 mg/TDF 300 mg) STR administered orally once daily
16238681|NCT01095796|Drug|Atripla|Atripla (EFV 600 mg/FTC 200 mg/TDF 300 mg) tablet administered orally once daily prior to bedtime
16238682|NCT01095796|Drug|Stribild Placebo|Placebo to match Stribild STR administered orally once daily
16238683|NCT01095796|Drug|Atripla Placebo|Placebo to match Atripla tablet administered orally once daily prior to bedtime
16238684|NCT01095783|Procedure|physiotherapeutic intervention|Twenty repetitive exercises (30 seconds per exercise) consisting of: flexion in standing, extension in standing, flexion in lying, and extension in lying position applied three times a week for eight weeks
16238685|NCT01095783|Procedure|control|The control group receive transcutaneous electrical nerve stimulation (TENS) for 20 min at 50-100 Hz frequencies for the same time frame (Anesth Analg 2004;98:1552-6)
16238686|NCT01095770|Procedure|AF Ablation with Ablation Frontiers Technology|AF Ablation with Ablation Frontiers Technology - PVAC, TVAC and MASC.
16238687|NCT01095770|Procedure|AF Ablation with LASSO catheter|AF Ablation with traditional LASSO catheter
16238688|NCT01095770|Device|Reveal XT|Reveal XT implantable loop recorder monitored group
16238689|NCT01095770|Device|Permanent Dual Chamber Pacemaker|This group will be monitored with a dual chamber pacemaker with advanced AF monitoring capabilities.
16238690|NCT01095757|Drug|Plerixafor|240 µg/kg subcutaneous injection on the day that the absolute neutrophil count (ANC) is > 1500/mm3 and on each day of apheresis for a total of 4 aphereses or the target CD34 cell dose has been reached.
16238881|NCT01094288|Drug|Alisertib|Alisertib ECT
16238691|NCT01095731|Drug|Tiopronin|Dosage will be 1 gram, 3 times daily. Drug dosing will be initiated at time of aSAH confirmation, for a length of 14 days or at hospital discharge.
16238692|NCT01095731|Drug|Placebo|Dosage will be 1 gram, 3 times daily. Drug dosing will be initiated at time of aSAH confirmation, for a length of 14 days or at hospital discharge.
16238693|NCT01095718|Behavioral|Errorless Learning|"Errorless learning refers to the use of feedforward instruction before actions to prevent learners from making mistakes. The therapist presents steps with the following instruction and the visual cues e.g., Here are steps that you need to do to make some coffee, please repeat them.
~The therapist gives cues before the completion of each step. At each step the patient receives verbal and visual cues. Then cue cards are hidden, and the therapist asks immediately to give the answer about the step involved.
~The therapist allows the participant to try finding the solution, if the answer or action is not immediately given, the participant receives a cue, and moves to the next step.
~During cueing the patient will mostly receive verbal and visual cues and if necessary physical help."
16238694|NCT01095718|Behavioral|Modeling|"The therapist gives the same tailored baseline information for each task. The therapist issue specific information for each step. Using tailored mastery modeling, the therapist shows the steps in front of the patient. There is a special emphasis on adjusting the modeling just above the patient's abilities.
~The therapist does the steps, at the same time he/she uses verbal cues during the performance.
~Then the therapist asks immediately to the patient to do the steps."
16238695|NCT01095718|Behavioral|Trial and Error|"The therapist gives the same tailored baseline information for each task. The therapist issue specific information for each step. Using tailored mastery modeling, the therapist shows the steps in front of the patient. There is a special emphasis on adjusting the modeling just above the patient's abilities.
~The therapist does the steps, at the same time he/she uses verbal cues during the performance.
~Then the therapist asks immediately to the patient to do the steps."
16238696|NCT01095705|Procedure|Conventional procedure|Local anaesthesia (Lidocaïne)
16238697|NCT01095705|Procedure|Conventional procedure + Hypnosis|Local anaesthesia (Lidocaïne) + Hypnosis (20 minutes)
16238698|NCT01095692|Procedure|Pelvic Organ Prolapse and Suburethral TOT implantation|Procedure/Surgery: Pelvic Organ Prolapse intervention and Suburethral TOT implantation
16238699|NCT01095692|Procedure|Pelvic Organ Prolapse intervention|Procedure/Surgery: Pelvic Organ Prolapse intervention
16238700|NCT01095679|Drug|Baclofen|Breaking tablets of 10 mg of baclofen. Dosage and frequency : 5 mg 3 times a day for 3 days, then 10 mg 3 times a day for 3 days, then 15 mg 3 times a day for 3 days, then 20 mg 3 times a day for 3-5 days, then 15 mg 3 times a day for 1 day, then 10 mg 3 times a day for one day, then 5 mg 3 times a day for one day.
16238701|NCT01095679|Drug|Placebo|Breaking tablets of 10 mg of placebo. Dosage and frequency : 5 mg 3 times a day for 3 days, then 10 mg 3 times a day for 3 days, then 15 mg 3 times a day for 3 days, then 20 mg 3 times a day for 3-5 days, then 15 mg 3 times a day for 1 day, then 10 mg 3 times a day for one day, then 5 mg 3 times a day for one day.
16238702|NCT01095666|Drug|Dapagliflozin|Tablets, Oral, 5 mg, Once daily, 24 weeks
16238703|NCT01095666|Drug|Dapagliflozin|Tablets, Oral, 10 mg, Once daily, 24 weeks
16238704|NCT01095666|Drug|Metformin|Tablets, Oral, 1500-3000 mg, Twice daily, 24 weeks
16238705|NCT01095666|Drug|Dapagliflozin Placebo|Tablets, Oral, 0 mg, Once daily, 24 weeks
16238706|NCT01095666|Drug|Pioglitazone|Tablets, Oral, 15-45 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks
16238707|NCT01095653|Drug|Dapagliflozin|Tablets, Oral, 5 mg, Once daily, 24 weeks
16238708|NCT01095653|Drug|Dapagliflozin|Tablets, Oral, 10 mg, Once daily, 24 weeks
16238709|NCT01095653|Drug|Metformin|Tablets, Oral, 500-2000 mg (as needed for rescue based on protocol specific criteria), Up to 20 weeks
16238710|NCT01095653|Drug|Dapagliflozin Placebo|Tablets, Oral, 0 mg, Once daily, 24 weeks
16238711|NCT01095640|Drug|adapalene 0.3% topical gel|once a day, 84 days
16238712|NCT01095627|Other|Metacholine challenge|Exhaled breath analysis following metacholine challenge
16238713|NCT01095601|Drug|Avanafil|"Treatment A: 2x100 mg Formulation II avanafil tablet, fasted
~Treatment B: 2x100 mg Formulation II avanafil tablet, fed
~Treatment C: 2x100 mg Formulation I avanafil tablet, fasted
~Treatment D: 1x50 mg Formulation II avanafil tablet, fasted"
16238714|NCT01095588|Drug|200 mg Avanafil|2 X 100mg tablets avanafil
16238715|NCT01095588|Drug|Placebo|2 tablets
16238716|NCT01095575|Drug|normal saline 3 ml, morphine 3mg|On the day of surgery, patients were brought to the operating room (OR) where routine monitors were placed and an epidural catheter was inserted at the level of L3-4 to a distance of 10 cm. All patients received two injections via the catheter: one injection contained 3 mg morphine (MO), and the other contained normal saline (NS) of the same volume. Patients were randomized to receive either NS preoperatively and MO postoperatively or vice versa. The first injection was administered 40 minutes before initiation of surgery, and the second one was given 15 minutes after surgery ended. All epidural catheters were removed before the patients were discharged from the post-anesthesia care unit (PACU).
16238717|NCT01095562|Drug|ABT-126|ABT-126 Dose 1, ABT-126 Dose 2
16238718|NCT01095562|Drug|Placebo|Placebo
16238719|NCT01095549|Device|WSTM TY101 FIR emitter (Far infrared therapy)|A WSTM TY101 FIR emitter (WS Far Infrared Medical Technology Co., Ltd., Taipei, Taiwan) will be used for FIR therapy. The electrified ceramic plates of this emitter generate electromagnetic waves with wavelengths in the range between 3 and 25 μm (a peak between 5 to 6 μm). The irradiating power density is 10 and 20 mili watt<mw>/cm2 when the top radiator is set at a distance between 30 and 20 cm above the skin surface respectively. In this study, the top radiator will be set at a height of 25 cm above the surface of bilateral lower legs and the treatment time will be set at 40 minutes for patients on each HD section for a year.
16238720|NCT01095549|Device|Placebo device|A device without far infrared therapy
16238721|NCT01095523|Procedure|Laparotomy+ HIPEC +/- CRS|
16238722|NCT01095510|Biological|CINRYZE|
16238723|NCT01095497|Biological|CINRYZE|C1 esterase inhibitor (human)
16238724|NCT01095484|Drug|Rotigotine patch|1 patch daily for up to 48 months. Patch strength (per 24 hours): 1 mg - 8 mg based on investigator's assessment
16238725|NCT01095471|Biological|PCV13|Immunisation with the 13-valent pneumococcal conjugate vaccine (PCV13) at approximately 40 months of age.
16238814|NCT01094808|Other|Bowel preparation|Polyethylene glycol electrolyte solution bowel preparation
16238726|NCT01095458|Behavioral|Phone versus Clinic Weight Management Programs|To determine if weight loss is equivalent between individuals that complete weight loss meetings in person versus on the phone.
16238727|NCT01095445|Drug|Peginterferon alfa-2b (Pegetron) plus ribavirin (Rebetol)|Dosage Form: Pegetron - powder for solution; Rebetol - capsules Strength: Pegetron Redipen - 120 mcg per pen; Rebetol - 200 mg Route of Administration: Pegetron - subcutaneous; Rebetol - oral
16238728|NCT01095432|Procedure|PWS Testing|Partial wave spectroscopy (PWS)has been developed to allow scientists to learn about any changes to the cells that may indicate a risk of developing colon cancer.
16238729|NCT01095419|Other|Massage Therapy|After discharge from the intensive care unit to the ward during the postoperative period, patients which were randomized for 3 nights to receive intervention (Massage Therapy)which were consisted of massage of the neck, shoulders, and back. The massage was initiated with light manual compression and progressed to deep compression. The compression was performed with the inner region of the fingers, hand-shaped clamp, and friction (digital compression with the thumb) on trigger points, cervical traction, and mobilization in all planes (front, back, and sides)
16238730|NCT01095419|Other|Control|no intervention
16238731|NCT01095406|Device|S1 ventilation|Ventilation with a O2 and CO2 controller
16238732|NCT01095380|Other|Locomotor training|Locomotor training using body weight support with training on a treadmill or training over ground with differing forms of assistance for stepping
16238733|NCT01095367|Procedure|Seprafilm™|"Seprafilm™ Adhesion Barrier is an approved temporary, bioresorbable adhesion barrier to reduce the incidence, extent, and severity of adhesions in patients undergoing abdominal or pelvic laparotomy.
~Seprafilm sheets are size 5 x 6 individually-wrapped, sterile membranes. Three or more Seprafilm™ sheets will be placed in the randomized cohort."
16238734|NCT01095354|Drug|Sodium Chloride Inhalation|"Spirometry: all subjects Plethysmography and exhaled nitric oxide: >6 years Multiple Breath Washout: Tidal breathing using a facemask <9 years or mouthpiece >9 years. Wash-in phase: gas mixture containing 4% SF6, 4% He, 21% oxygen and balance nitrogen inhaled until steady state. Bias flow stopped during expiration by removal of T-piece. Wash-out phase: patient inspires room air and exhales tracer gas until SF6 reaches <0.1%.
~Bronchodilator response: Bronchodilator (Salbutamol 400 mcg) to asthma subjects, spirometry and MBW repeated after 15 minutes.
~Induced sputum in asthma subjects >10 yrs. Post-bronchodilator spirometry, subject inhales concentrations of 3, 4 and 5% hypertonic saline for 7 minutes for 3 cycles until expectorating sputum."
16238735|NCT01095341|Other|No intervention performed|
16238736|NCT01095328|Other|screening|screening for Q-fever with a single blood sampling
16238737|NCT01095315|Other|lateral positioning|the lateral position was maintained for 6 min after spinal injection before patients were turned to the supine position
16238738|NCT01095302|Drug|OMBRABULIN (AVE8062)|"Pharmaceutical form:injection solution
~Route of administration: intravenous infusion"
16238739|NCT01095302|Drug|cisplatin|"Pharmaceutical form:injection solution
~Route of administration: intravenous infusion"
16238740|NCT01095302|Drug|docetaxel|"Pharmaceutical form:injection solution
~Route of administration: intravenous infusion"
16238741|NCT01095276|Drug|Pulmozyme (nebulized dornase alpha)|nebulized dornase alpha: 2.5 mg by in-line nebulizer BID
16238742|NCT01095276|Drug|Saline|Saline packaged identically to the dornase alpha intervention unit doses and coded for blinding by the company providing the intervention drug (dornase alpha).
16238743|NCT01095263|Device|DBS|130Hz, 90us pulsewidth, 4V Amplitude
16238744|NCT01095263|Device|No Stimulation (Sham)|130Hz, 90us pulsewidth, 0V Amplitude
16238745|NCT01095250|Drug|AIN457|
16238746|NCT01095250|Drug|AIN457|
16238747|NCT01095250|Drug|AIN457|
16238748|NCT01095250|Drug|Placebo|
16238749|NCT01095237|Device|ProEndoTecc Vascular Graft|Implantation of the device as an interponate / bypass of the superficial femoral artery
16238750|NCT01095224|Biological|rAd35 Env A|1 x 10^10 particle units (PU) administered as 1 mL intramuscularly (IM) in deltoid
16238751|NCT01095224|Biological|rAd5 Env A|1 x 10^10 PU administered as 1 mL IM in deltoid
16238752|NCT01095224|Biological|rAd5 Env B|1 x 10^10 PU administered as 1 mL IM in deltoid
16238753|NCT01095211|Drug|B-vitamin complex|5 mg Folic acid, plus 1 mg cyanocobalamin and 40 mg vitamin B6) oral/ day. The placebo capsule contained 400 mg of mannitol: aerosil (99.5: 0.5). In addition, 1 mg/s.c cyanocobalamin daily
16238754|NCT01095198|Device|offer of vaginal self collection|Women assigned to the intervention group will be offered the opportunity to self collect a vaginal specimen for HPV testing. They will be sent a letter explaining that a study of self testing is being performed, and will invite her to participate in this study. The letter will state that, if the patient prefers, she can perform a vaginal self-test in addition to, or instead of Pap smear testing. Patients are told that they have the option of completing the self-test on their own or in their physician's office with the help of their physician or practice staff. The letter will be accompanied by a self collection kit consisting of: a swab and test tube, pamphlet (with written instructions and diagram outlining procedure), instructional DVD and return envelope.
16238755|NCT01095198|Other|2nd reminder letter for Pap testing|Women in both groups will receive a letter informing them that they are due for cervical screening. This is a standard letter, and is signed by the patient's individual family physicians. It will advise the patient that this is the second reminder letter that she is due for cervical cancer screening, and will invite her to phone the physician's office to obtain an appointment for Pap testing.
16238756|NCT01095185|Drug|Simvastatin|Simvastatin 20 mg for 15 days, then 40 mg until the end of the study.
16238757|NCT01095185|Drug|Placebo|Simvastatin placebo
16238758|NCT01095172|Drug|Rituximab|375mg/m^2, single dose given 2-4 weeks prior to transplantation
16238759|NCT01095172|Drug|Tacrolimus|dose calculated to give levels of 3-7ng/ml
16238760|NCT01095172|Drug|Mycophenylate mofetil|Mycophenylate mofetil 2g/day in divided doses
16238761|NCT01095172|Drug|Hydrocortisone|100mg hydrocortisone on the evening of the day of surgery and 2 further doses of hydrocortisone on day 1 post transplant.
16238762|NCT01095172|Drug|Prednisolone|Prednisolone 0.3mg/kg on day 2, 0.25mg/kg on day 3, 0.2mg/kg on day 4 and 0.16mg/kg on day 5. On day 6 they will receive 5mg prednisolone, and on day 7 none.
16238763|NCT01095172|Drug|Prednisolone|Reducing dose of prednisolone over at least 6 months. Subsequent steroid maintenance or withdrawal will be at the discretion of the patient's clinician.
16238764|NCT01095159|Device|TVT-O|Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator sling TVT-O™ (Gynecare™, USA).
16238765|NCT01095159|Device|TVT-S|Subjects of this group were submitted to surgical treatment of stress urinary incontinence with a transobturator mini-sling; TVT-Secur™ (Gynecare™, USA).
16238766|NCT01095133|Drug|Amiloride|dosage form: intraesophageal amiloride infusion dosage: liquid 1 mM amiloride concentration duration: 5 minute infusion given once frequency: 1 time
16238767|NCT01095133|Drug|Placebo|dosage form: intraesophageal saline infusion dosage: normal Saline (0.91% w/v of NaCl) duration: 5 minutes given once frequency: 1 time
16238768|NCT01095120|Drug|Tesetaxel|"For subjects in Cohort A, a flat dose of 40 mg will be administered in Cycle 1; the dose will be adjusted based on body weight. In subsequent cycles, depending on tolerability, the Cycle 1 flat dose may be increased by 5 mg in Cycle 2, and the Cycle 2 flat dose may again be increased by 5 mg in Cycle 3.
~For subjects in Cohort B, a flat dose of 50 mg will be administered in Cycle 1; the dose will be adjusted based on body weight. In subsequent cycles, depending on tolerability, the dose may be increased by 10 mg in Cycle 2.
~For subjects in Cohort C, a dose of 27 mg/m2 will be administered in Cycle 1. In subsequent cycles, depending on tolerability, the dose will be increased to 35 mg/m2 in Cycle 2."
16238769|NCT01095107|Dietary Supplement|Low fat intake|low fat intake : Intake 35-50 grams of fat per day between meals and snacks
16238770|NCT01095107|Dietary Supplement|Increased fat intake|increased fat intake : Intake > 50 grams of fat per day between meals and snacks
16238771|NCT01095094|Drug|ritonavir|Given orally
16238772|NCT01095094|Drug|lopinavir|Given orally
16238773|NCT01095081|Drug|Gadobutrol (Gadovist, BAY86-4875)|Patients requiring contrast enhanced MRI using Gadovist. Administration of Gadovist at the discretion of the attending physician.
16238774|NCT01095068|Behavioral|Physical exercise|
16238775|NCT01095055|Biological|AdCh63 AMA1|Group 1A - single dose of AdCH63 AMA1 5x10^9 vp intramuscularly Group 2A - single dose of AdCH63 AMA1 5x10^10 vp intramuscularly
16238776|NCT01095055|Biological|AdCh63 AMa1 and MVA AMA1|Group 1B - single dose of AdCH63 AMA1 5x10^9 vp intramuscularly and single dose of MVA AMA1 5x10^8 pfu 8 weeks later intramuscularly Group 2B - single dose of AdCH63 AMA1 5x10^10 vp intramuscularly and single dose of MVA AMA1 5x10^8 pfu 8 weeks later intramuscularly
16238777|NCT01095042|Behavioral|emotion|Show that the susceptibility in the stress (recording of Heart Rate Variability;viewing films;...) is more important at the person affected by digestive pathologies (SII or IBD) in forgiveness than to unhurt subjects of pathologies.
16238778|NCT01095029|Device|Medtronic InterStim II - 3058|Stimulation with optimal pacemaker settings unilateral and bilateral with standard pacemaker settings: Amplitude sensory treshold, frequency 14 Hz and impulsduration 210 μsec.
16238779|NCT01095016|Drug|Meptin swinghaler|"Dose: 10ug/puff, 2 puffs daily
~Frequency: QD (total 20ug/day)
~Treatment duration: 2 days"
16238780|NCT01095016|Drug|Berotec|"Dose: 100ug/puff, 2 puffs daily
~Frequency: QD (total 200ug/day)
~Treatment duration: 2 days"
16238781|NCT01095003|Drug|Vinflunine plus Capecitabine|"Vinflunine 280mg/m² as a 20-minute i.v. infusion on day 1 of each cycle repeated every 3 weeks
~Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks"
16238782|NCT01095003|Drug|Capecitabine|Capecitabine 825mg/m² per os twice per day for 14 consecutive days starting day 1 of each cycle repeated every 3 weeks
16238783|NCT01094990|Drug|Dexamethasone|dexamethasone 0.25 mg/kg (8 mg/m2/dose) intravenous one time
16238784|NCT01094977|Drug|Tranexamic Acid|10 mg/kg bolus with a 5 mg/kg/h infusion
16238785|NCT01094977|Drug|Tranexamic Acid|100 mg/kg bolus with a 10 mg/kg/h infusion
16238786|NCT01094977|Drug|Saline Placebo|
16238787|NCT01094964|Biological|BCG solution|
16238788|NCT01094964|Biological|recombinant interferon alfa|
16238789|NCT01094964|Drug|epirubicin hydrochloride|
16238790|NCT01094964|Drug|mitomycin C|
16238791|NCT01094964|Other|laboratory biomarker analysis|
16238792|NCT01094964|Procedure|hyperthermia treatment|
16238793|NCT01094964|Procedure|quality-of-life assessment|
16238794|NCT01094951|Behavioral|ENGAGE|During Stage 2, investigators will train Neighborhood House caseworkers to 1. provide psychoeducation that addresses client-specific barriers to evaluation and care; 2. use shared decision-making strategies to engage seniors and arrive at a decision about where and from whom to receive an evaluation and possible care; and 3. provide connections to preferred community-based mental health services.
16238795|NCT01094925|Drug|lactose|Single oral dose
16238796|NCT01094925|Drug|Gabapentin 300mg|Single oral dose of 300mg gabapentin
16238797|NCT01094925|Drug|Gabapentin 600mg|Single oral dose of 600mg gabapentin
16238798|NCT01094912|Drug|opioids|
16238799|NCT01094899|Radiation|Radiography|Radiography, microscanner, osteodensitometry
16238800|NCT01094899|Other|Urine and Blood sampling|mainly dosage of bones metabolism
16238801|NCT01094899|Other|Echography|body bones echography
16238802|NCT01094886|Drug|Rivaroxaban|10mg tablet daily, receiving the first dose within two days after admission to the subacute unit. The total duration of combined venous blood clot prevention therapy with enoxaparin and rivaroxaban may not exceed 35 days for patients with total hip replacement or 14 days with total knee replacement
16238803|NCT01094873|Biological|AdCh3NSmut|Genetic vaccines against Hepatitis C virus infection
16238804|NCT01094873|Biological|Ad6NSmut|Genetic vaccine against Hepatitis C virus infection
16238805|NCT01094860|Drug|Nelarabine|Starting dose 200 mg/m2 for 5 day continuous infusion administered via a central catheter, repeated every 28 days.
16238806|NCT01094847|Drug|DWJ1252|tablet(oral) administration following the schedule of each arm
16238807|NCT01094834|Drug|DWP05195|tablets, oral administration, multiple administration
16238808|NCT01094821|Drug|ATI-7505|3 mg three times daily for 9 days
16238809|NCT01094821|Drug|Placebo|Placebo capsule three times daily for 9 days
16238810|NCT01094821|Drug|ATI-7505|10 mg ATI-7505 three times daily for 9 days
16238811|NCT01094821|Drug|ATI-7505|20 mg ATI-7505 three times daily for 9 days
16238812|NCT01094808|Drug|Pregabalin|FDA approved medication (capsules) at 75 mg and 200 mg doses
16238813|NCT01094808|Drug|Placebo|Placebo capsules
16238816|NCT01094782|Other|Sham Acupuncture|Subjects receive 6 sham acupuncture treatments for neck or back pain.
16238817|NCT01094769|Drug|Moxonidine|Patients will receive moxonidine treatment for 12 weeks, at a dose of 0.4mg/d for the first 6 weeks of treatment followed by up-titration of the dose to 0.6 mg/d for the final 6 weeks.
16238818|NCT01094769|Drug|Placebo|lactose capsule taken once daily
16238819|NCT01094756|Dietary Supplement|meal replacements, psychotherapy, dietary education|After the screening and scan days are completed, obese subjects will begin a lifestyle intervention program that includes dietary (low-calorie diet) and behavioral education topics. Treatment will be provided in individual weekly sessions. Each hour-long session will be led by a behavioral counselor or registered dietitian in the Weight Management Center at Washington University. The behavioral program will use cognitive-behavioral techniques to foster adherence to diet prescriptions and to build a supportive environment for the participant. The program will emphasize strategies of self-monitoring and goal-setting, and will include problem-solving, overcoming high-risk situations for unhealthy eating, relapse prevention, and strategies for long-term weight maintenance. Handouts will be provided for study subjects to allow them to record the setting and reaching of dietary goals, as well as summarize the key points of the educational content.
16238820|NCT01094743|Device|galyfilcon A prototype lens|Silicone hydrogel contact lens
16238821|NCT01094743|Device|lotrafilcon B lens|Silicon Hydrogel contact lens
16238822|NCT01094730|Device|galyfilcon A prototype lens|Experimental silicone hydrogel contact lens
16238823|NCT01094730|Device|marketed galyfilcon A lens|Marketed silicone hydrogel contact lens.
16238824|NCT01094717|Drug|Acitretin 25Mg Oral Capsule|Acitretin 25 mg oral daily for 12 weeks
16238825|NCT01094717|Device|Excimer laser|Lesions on randomly assigned left or right side of body were treated with 308nm excimer laser.
16238826|NCT01094717|Drug|Tazarotene 0.1% Gel,Top|Topical tazarotene 0.1% gel was applied daily to active lesions.
16238827|NCT01094717|Device|Sham excimer laser|Lesions on randomly assigned left or right side of body were treated with sham excimer laser (opaque cover on the laser device).
16238828|NCT01094704|Drug|sodium chloride (7%)|4mL nebulized 7% sodium chloride
16238829|NCT01094691|Procedure|Renal Allograft Biopsy|A renal allograft biopsy will be performed when the urine is determined to be Haufen negative.
16238830|NCT01094678|Device|Zilver® PTX™ Stent|Stenting of the superfemoropopliteal artery.
16238831|NCT01094665|Procedure|MRI Targeted Focal Laser Thermal Therapy|A 980nm wavelength diode laser will be fired for up to 30 minutes. Temperature probes will be inserted to ensure that the local temperature does not exceed 55 degrees Celsius for more than 5 minutes.
16238832|NCT01094652|Dietary Supplement|Whole grain diet|Subjects were told to consume three different kinds of study food each day. The goal was an intake of greater than or equal to 80 g of whole grains per day.
16238833|NCT01094652|Dietary Supplement|Refined grain diet|The refined grain food products were matched as closely as possible to the foods contained in the whole grain diet. Subjects were told to consume three different kinds of study food each day.
16238834|NCT01094639|Procedure|Scaling root planing|Deep gum cleaning with local anesthesia
16238835|NCT01094639|Procedure|Supragingival Prophylaxis|Plaque removal
16238836|NCT01094626|Drug|Secretin|Subjects will each undergo an S-MRI evaluation, at a dose of 0.2 ucg/kg per exam. Secretin will be administered by IV bolus injection over 1 minute followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg.
16238837|NCT01094613|Drug|Delayed Release 6 mercaptopurine|"Delayed Release oral tablet for ileal drug delivery, 80 mg, once nightly before bedtime, for 12 weeks.
~Since the study drug must be blinded, patients randomized to this arm will receive the following: 80 mg DR-6MP: 2 active 40 mg DR-6MP tablets."
16238838|NCT01094613|Drug|6 Mercaptopurine|Oral tablet(s) to be administered once daily in the AM, for 12 weeks.Purinethol is available only as a 50 mg tablet; patients randomized to this arm will receive varying doses (dependent on baseline body weight and AE profile) throughout the study;and study drug to be blinded. Therefore, patients randomized to this arm to receive combination active Purinethol/comparable placebo. For ex: 50 mg Purinethol= 1 active 50 mg tablet, 2 comparable placebo tablets; 100 mg Purinethol = 2 active 50 mg tablets, 1 placebo tablet; 150 mg Purinethol = 3 active 50 mg tablets. Patients receiving 75 mg or 125 mg will receive alternating daily doses of 50 and 100 mg, or 100 and 150 mg, respectively, to arrive at a weekly average dose of 75 mg or 125 mg.
16238839|NCT01094600|Drug|Synthetic Human Secretin|Twelve patients will undergo S-MRCP, at a dose of 0.2 ucg/kg per exam. Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg.
16238840|NCT01094587|Procedure|Gastroschisis closure with suture|
16238841|NCT01094587|Procedure|Gastroschisis closure without suture|
16238842|NCT01094574|Drug|Alfentanil|An infusion of alfentanil 100ng/ml was administered over 3 hours using a programmable infusion pump.
16238843|NCT01094574|Drug|Propranolol|An infusion of propranolol 30ng/ml was administered over 3 hours using a programmable infusion pump.
16238844|NCT01094574|Drug|Placebo|An infusion of normal saline was administered over 3 hours using a programmable infusion pump to mimic the 2 drug arms,
16238845|NCT01094561|Drug|Synthetic Human Secretin|Subjects will each undergo a Secretin-Enhanced Magnetic Resonance Cholangiopancreatography (S-MRCP) and a Secretin-Enhanced Endoscopic Ultrasound (S-EUS) evaluation, at a dose of 0.2 ucg/kg per exam. Synthetic Human Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg.
16238846|NCT01094561|Procedure|Secretin-Enhanced Magnetic Resonance Cholangiopancreatography|
16238847|NCT01094561|Procedure|Secretin-Enhanced Endoscopic Ultrasound|
16238848|NCT01094548|Biological|Tecemotide (L-BLP25)|After receiving single low dose of cyclophosphamide, subjects will receive 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide (L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy is documented.
16238882|NCT01094288|Drug|Docetaxel|Docetaxel IV infusion
16238883|NCT01094275|Drug|Clopidogrel 75mg, Omeprazole 20mg|Clopidogrel and or Omeprazole as applicable
16239189|NCT01092143|Drug|Fluticasone placebo|double blind randomized parallel
16238849|NCT01094548|Biological|Tecemotide (L-BLP25)|After receiving multiple low dose of cyclophosphamide, subjects will receive 8 consecutive weekly subcutaneous vaccinations with 806 mcg of tecemotide (L-BLP25) at Weeks 1, 2, 3, 4, 5, 6, 7 and 8 followed by maintenance vaccinations (806 mcg of tecemotide (L-BLP25) at 6-Week intervals, commencing at Week 14, until disease progression requiring anti-tumor therapy is documented.
16238850|NCT01094548|Drug|Single low dose cyclophosphamide|An intravenous (IV) infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide will be given 3 days before the first vaccine treatment.
16238851|NCT01094548|Drug|Multiple low dose cyclophosphamide|An IV infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide will be given 3 days before the first vaccine treatment plus an intravenous dose of cyclophosphamide (300 mg/m^2, to a maximum of 600 mg) 3 days prior to the tecemotide (LBLP25) administration at week 5 of the weekly treatment phase and 3 days prior to every tecemotide (L-BLP25) administration during the treatment phase with 6-Weekly administration of tecemotide (L-BLP25), commencing at Week 14 up to a maximum treatment period of 2 years.
16238852|NCT01094535|Drug|Synthetic Human Secretin|S-MRCP has recently emerged as a widely-accepted noninvasive technique to assess morphological changes in the pancreatic ducts, as well as functional secretory capacity of the gland. Twelve patients will each undergo four Secretin-enhanced magnetic resonance cholangiopancreatography (S-MRCP) evaluations, at a dose of 0.2 ucg/kg per exam, each S-MRCP will require 16-32 ucg of secretin (12 vials). Secretin, provided by the Repligen Corporation, will be administered by IV bolus injection over 30 seconds followed by a 30 second saline flush. The maximum dose of secretin will be 18.5 ucg.
16238853|NCT01094522|Drug|Methadone|"0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of methadone may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
16238854|NCT01094522|Drug|Morphine|"0.2 mg/kg (IV) for the Initial Loading Dose; followed by PRN (as needed) doses (given by the ICU Nurses) starting at 0.035 mg/kg (IV) every 30 minutes, for postoperative pain. The PRN dose of morphine may be increased by the ICU doctors until the dose is adequate to relieve the patient's pain."
16238855|NCT01094509|Behavioral|Tai Chi|Tai Chi classes and exercises
16238856|NCT01094509|Behavioral|Guided autobiography|Autobiographical writing in class and at home
16238857|NCT01094509|Behavioral|Qigong|Qigong classes and exercises (exploratory)
16238858|NCT01094509|Behavioral|Successful aging|Seminar series on the theme of successful aging
16238859|NCT01094509|Behavioral|Combination|Combination of Tai Chi exercises and autobiographical writing
16238860|NCT01094509|Behavioral|Comparison|No assigned behavioral activity (exploratory)
16238861|NCT01094496|Biological|CDX-1307 Vaccine Regimen|CDX-1307 vaccine co-administered with immune adjuvants (GM-CSF, Poly-ICLC and Resiquimod)
16238862|NCT01094496|Drug|Chemotherapy|
16238863|NCT01094483|Drug|PN400|naproxen 500 mg/esomeprazole 20 mg oral tablet
16238864|NCT01094483|Drug|ASA|Asprin 81 mg enteric coated tablet
16238865|NCT01094483|Drug|Placebo|
16238866|NCT01094470|Device|Body weight support system on ground level|Gait training with body weight support on ground level with sessions of 45 minutes, three times a week, on alternating day during six weeks, completing a total of 18 sessions.
16238867|NCT01094457|Drug|aspirin, clopidogrel|patients in the standard group received standard dual antiplatelet therapy: aspirin 300mg/d for 30 days followed by 100mg/d indefinitely, clopidogrel 75mg/d for at least 1 year
16238868|NCT01094457|Drug|aspirin, clopidogrel, cilostazol|Firstly,all patients in this group were received aspirin 300mg/d and clopidogrel 150mg/d for 3 days. Then a platelet aggregation function test was performed. The regimen will lasted for another 27 days if patients were judged as responsive to current clopidogrel dose. Patients still with clopidogrel resistance were then randomly assigned to receive clopidogrel 75mg/d plus cilostazol 100mg, twice per day or clopidogrel 150mg/d plus cilostazol 50mg, twice per day for 27 days. At 30-day, a repeat platelet aggregation function test wil performed for all patients. Then a standard dual antiplatelet regimen with aspirin 100mg/d indefinitely and clopidogrel 75mg/d for at least 1 year will be prescribed for all patients.
16238869|NCT01094444|Other|Vitamin K3|Lotion containing 1.5 mM Vitamin K3
16238870|NCT01094418|Other|Nerve conduction studies ( NCS) of the peripheral nerves|"Standard NCS of the sural, superficial peroneal sensory nerves, peroneal, tibial motor nerves, radial and median sensory nerves, median motor nerves, F-wave studies of the Tibial and median nerves.
~NCS of the distal sensory nerves; dorsal sural Medial dorsal cutaneous and medial plantar nerves."
16238871|NCT01094405|Biological|Recombinant Epstein-Barr Virus (EBV) Vaccine|
16238872|NCT01094379|Procedure|Standard laparoscopic cholecystectomy|Laparoscopic cholecystectomy using four entry sites to the abdominal cavity
16238873|NCT01094379|Procedure|Single incision laparoscopic cholecystectomy|Laparoscopic cholecystectomy using one entry site to the abdominal cavity
16238874|NCT01094366|Procedure|Paracervical Block|Subject receives 20 mL paracervical block with 18 mL of 1% Lidocaine solution buffered with 2 mL 8.4% sodium bicarbonate for pain control.
16238875|NCT01094366|Procedure|Sham Paracervical Block|In the non-intervention group, the surgeon performs a sham PCB during which 2 mL buffered lidocaine solution are injected at the tenaculum site, after which a capped needle gently simulates the standard PCB procedure.
16238876|NCT01094353|Procedure|Mini-sling|The minisling is a new intervention therapeutic option for surgical treatment in women with stress urinary incontinence. It is made of polypropylene monofilament mesh, held between two self-anchoring polypropylene columns in a fishbone design connected to two delivering needles.
16238877|NCT01094353|Procedure|Transobturator|Transobturator sling Unitape™ is an outside-in approach therapeutic option for surgical treatment in women with stress urinary incontinence
16238878|NCT01094340|Drug|Thalidomide|fixed dose over 8 clinic visits
16238879|NCT01094314|Other|embryo culture medium|comparison between two types of embryo culture medium
16238880|NCT01094301|Device|The SPR System|The SPR System is an investigational two-staged device which delivers stimulation to the shoulder. Subjects with chronic post-stroke shoulder pain who meet eligibility criteria for the first stage (SPR Trial Stage) will receive a temporary Lead and External Stimulator. Subjects who qualify and who agreed to proceed will advance to the second stage (SPR Implant Stage) which uses an Implantable Pulse Generator (IPG) and Implantable Lead. Subjects will be followed until 36-months after IPG stimulation has been started.
16238884|NCT01094262|Drug|Oxycodone CR (standard pain medication)|Oxycodone CR: Type=exact number, unit=mg, number= 10-50, form=capsule, route=oral use and Placebo: Form=solution for injection, route=Subcutaneous use. Oxycodone CR capsule twice a day for 16 weeks and one placebo injection every 4 weeks for 16 weeks.
16238885|NCT01094262|Drug|JNJ-42160443|JNJ-42160443: Type=exact number, unit=mg, number= 3, form=solution for injection, route=Subcutaneous use and Placebo: Form=capsule, route=Oral use. One injection of JNJ-42160443 every 4 weeks and a placebo capsule twice a day for 16 weeks.
16238886|NCT01094262|Drug|JNJ-42160443|JNJ-42160443: Type=exact number, unit=mg, number= 9, form=solution for injection, route=Subcutaneous use and Placebo: Form=capsule, route=Oral use. One injection of JNJ-42160443 every 4 weeks and a placebo capsule twice a day for 16 weeks.
16238887|NCT01094262|Drug|Placebo|Form=solution for injection, route=Subcutaneous use and Form=capsule, route=Oral use. One placebo injection every 4 weeks and a placebo capsule twice a day for 16 weeks.
16238888|NCT01094249|Drug|divalproex sodium ER/paliperidone ER|Divalproex sodium ER (dose determined from the patients prescreening therapeutic dose) once daily from Day 1 through Day 7 and once daily in combination with paliperidone ER 12 mg from Day 8 through Day 12
16238889|NCT01094236|Behavioral|On the Playground behavior management program|Treatment school playground supervisors were show the CD intervention. Control school playground supervisors were given a video on playground equipment safety. All school staff subjects were assessed before the intervention and 75 days following the supervisor intervention. Students were assessed before the intervention, and then 45 days and 75 days following the supervisor intervention. School Administrators were assessed before the intervention, and then 30 and 60 days after the supervisor intervention - school administrators at treatment schools had access to a treatment binder with CDs and worksheets, while the control school administrators did not.
16238890|NCT01094223|Behavioral|Mindfulness Based Relapse Prevention|Meditation based therapy group incorporating relapse prevention skills training
16238891|NCT01094223|Behavioral|Health Education|Psychoeducation group focused on various topics pertaining to physical health
16238892|NCT01094210|Drug|Fluorides, Topical|500 ppm F and 1100 ppm F topical toothpastes comprise sodium fluoride in each.
16238893|NCT01094184|Drug|Bevacizumab|Bevacizumab will be administered at a dose of 10 mg/kg Q2W or 15 mg/kg Q3W as intravenous infusion.
16238894|NCT01094184|Drug|Paclitaxel|Paclitaxel will be administered as intravenous infusion Q1W as per discretion of the treating physician.
16238895|NCT01094184|Drug|Docetaxel|Docetaxel will be administered as intravenous infusion Q3W as per discretion of the treating physician. Protocol amendment 2 (dated 17-Feb-2011) removed the option to choose docetaxel.
16238896|NCT01094171|Biological|Poliorix TM|Intramuscular administration, 3 doses
16238897|NCT01094171|Biological|Infanrix TM|Intramuscular administration, 3 doses
16238898|NCT01094158|Drug|Aramchol|100mg/d tablets packaged in bottles given orally once a day in the morning within 10 minutes after breakfast for a total period time of 3 months
16238899|NCT01094158|Drug|Aramchol|300 mg/d tablets packaged in bottles given orally once a day in the morning within 10 minutes after breakfast for a total period time of 3 months
16238900|NCT01094158|Drug|Placebo|tablets packaged in bottles given orally once a day in the morning within approximately 10 minutes after breakfast
16238901|NCT01094145|Other|Deep brain stimulation|DBS in the Nucleus basalis Meynert
16238902|NCT01094132|Device|Multispectral Digital Colposcope (MDC)|"The MDC has 2 components: an optical probe & a multispectral colposcope. The optical wand makes use of fluorescence & reflectance spectroscopy; a light is shone on the cervix and the wand reports what it sees to a computer. Since cancer & healthy cells interact differently with light, a computer can detect abnormalities. The multispectral colposcope is based on a conventional colposcope, which is already widely used. However, it is also able to produce fluorescence & polarized reflectance images of the entire cervix. Computer analysis of these images can detect abnormalities on the cervix, defining their location and shape.
~This trial involves combined analysis of MDC data. This may lead to more effective diagnosis of cervical abnormalities. The MDC will be used with standard care for patients presenting with cervical abnormalities (as detected by a Pap test). The MDC will not be used to guide patient management decisions.
~All study subjects will receive this same intervention."
16238903|NCT01094119|Device|heated blanket|heated blanket
16238904|NCT01094119|Device|heated pad|patients will be warmed with a heated pad during surgery.
16238905|NCT01094106|Drug|Ropivacaine 0,75%|Postoperative wound infusion 2 ml/ h/ 48h
16238906|NCT01094106|Drug|NaCl 0,9%|Postoperative wound infusion 2 ml/h/48h
16238907|NCT01094093|Drug|AMG 139|Six dose levels of AMG 139 administered as a single dose SC or IV in healthy volunteers (Part A) and subjects with moderate-severe psoriasis (Part B).
16238908|NCT01094080|Other|standard infant formula|infants are fed a commercial formula
16238909|NCT01094080|Other|modified infant formula|the modified infant formula has a different protein content than the standard formula and long chain polyunsaturated fatty acids are added
16238910|NCT01094080|Other|breast milk|infants are breast fed
16238911|NCT01094067|Drug|ACT-050089|5 mg/h intravenously, Tezosentan
16238912|NCT01094067|Other|Placebo|Matching placebo
16238913|NCT01094054|Procedure|Adjustable gastric banding|Placement of adjustable gastric band - laparoscopically
16238914|NCT01094054|Behavioral|Dietary and lifestyle modification|"Dietary and lifestyle modification
~Subjects will meet with a dietitian and a psychologist on a weekly basis and consume a diet matched to that of the banding arm"
16238915|NCT01094041|Other|Gluten free diet|A 4-week gluten free diet provided
16238916|NCT01094041|Other|Gluten rich diet|A 4-week gluten rich diet is provided
16238917|NCT01094028|Drug|Oxytocin|20 IU of oxytocin diluted with 26 ml of saline.The medication was injected directly in the umbilical vein after clamping. The injection was performed with a 30-ml syringe and an 18-gauge needle around 1 to 2 cm from the introitus. The solution was injected slowly over 1 minute, and at the end of the injection, the solution was milked toward the cord insertion
16238918|NCT01094015|Drug|lidocaine-prilocaine cream|Implementation of 3 cm of lidocaine-prilocaine in the endocervical canal, 10 minutes before the intervention with a syringe without needle 5ml. Application, with a swab of the anesthetic cream ectocervix level.
16239101|NCT01092845|Drug|PF-04457845 / matched placebo|PF-04457845 4 mg tablet once daily / matched placebo
16239285|NCT01091506|Other|Placebo|Placebo once a day for 12 weeks
16238919|NCT01094015|Other|gel application for the transmission of ultrasound|3 cm of gel application for the transmission of ultrasound into the endocervical canal 10 minutes before surgery, with a 5ml syringe without needle. Application, with a swab in gel ectocervix
16238920|NCT01094002|Other|Occupational therapy intervention|"Day 1: Physical, functional, cognitive, social, and emotional assessment. Need analysis for iatrogenic prevention, retraining in BADL and IADL, technical aids, instructions in patient mobilisation techniques, and for social and occupational motivation.
~Day 2 until discharge: 45-minute sessions. Cognitive stimulation and confusional syndrome prevention, instructions to the caregivers on how to prevent complications such as immobility, delirium, falls, urinary incontinence, or pressure sores, and patient stimulation, retraining in activities of daily living.
~Day of discharge: Instruction for caregivers on managing the patient's residual deficits, assessment for technical aids, recommendations for patient increased independence in ADL, and social and occupational activities."
16238921|NCT01093989|Dietary Supplement|Ferrous Sulphate Syrup|Iron therapy will consist of a three-month course of ferrous sulphate syrup. For children with Hb ≥ 7 g/dL, each daily dose will be based on 2 mg iron/kg body weight.
16238922|NCT01093976|Drug|Dronabinol|2.5mg-15mg by mouth once a day for twelve-weeks
16238923|NCT01093963|Drug|Lisdexamfetamine|oral; 20-70mg/day
16238924|NCT01093963|Drug|Placebo|oral; 20-70mg/day
16238925|NCT01093937|Drug|varenicline|One to four 0.5 mg capsules (0.5-2.0 mg) orally per day for ten weeks.
16238926|NCT01093924|Behavioral|PILI 'Ohana 18-month weight loss maintenance|All participants will receive a 8 lesson 3-month weight loss intervention. They will then be randomized. Those continuing with the intervention will receive 17 more lessons delivered face-to-face or via DVD over 15 months for a total of 18 months. Each lesson lasts approximately 1 hour and helps participants integrate healthy eating and physical activity into their lifestyles. Participants will also be encouraged to attend 13 community activities during the last 13 months of the intervention.
16238927|NCT01093911|Biological|CDP7657|Ascending single doses of CDP7657
16238928|NCT01093911|Other|Placebo|Placebo: 0.9% sodium chloride aqueous solution
16238929|NCT01093885|Drug|Ambrisentan|"Drug is dispensed in tablet form. Ambrisentan with anti-fibrotic to assess benefit on skin
~Dosing of ambrisentan will begin at 5mg daily for the first month. Half the patients will remain at 5mg daily, while the remaining patients will be increased to a maintenance dose of 10mg daily on the fourth week."
16238930|NCT01093872|Device|Repetitive Transcranial Magnetic Stimulation (rTMS)|"Upon recruitment, all patients will undergo a 1 week treatment consisting of 5 rTMS sessions
~Repetitive TMS consists of 1000 stimulations/ day at 1 Hz and 110% of the motor threshold, for five consecutive days over the left AC."
16238931|NCT01093859|Drug|PRX-105|Sterile solution for intravenous injection
16238932|NCT01093846|Drug|AIN457|300mg every 4 weeks
16238933|NCT01093846|Drug|AIN457|300mg every 2 weeks
16238934|NCT01093846|Drug|Placebo AIN457|Placebo to AIN457
16238935|NCT01093833|Device|BD Continuous glucose monitor (BD CGM)|Continuous glucose monitoring for 12-14 hours
16238936|NCT01093833|Device|YSI Glucose Analyzer|Continuous glucose monitoring for 12-14 hours
16238937|NCT01093833|Device|Medtronic Guardian CGM|Continuous glucose monitoring for 12-14 hours
16238938|NCT01093820|Drug|methoxy-polyethyleneglycol epoetin beta|Mircera® 150μg i.v., before / during reperfusion of the infarct related coronary artery followed by Mircera® 30μg s.c. at 1 and 2 months post-MI
16238939|NCT01093807|Drug|Placebo|once daily for 10 weeks
16238940|NCT01093807|Drug|Lercanidipine|10 mg once daily for 10 weeks
16238941|NCT01093807|Drug|Lercanidipine|20 mg once daily for 10 weeks
16238942|NCT01093807|Drug|Enalapril|10 mg once daily for 10 weeks
16238943|NCT01093807|Drug|Enalapril|20 mg once daily for 10 weeks
16238944|NCT01093807|Drug|Lercanidipine + Enalapril|10/10 mg once daily for 10 weeks
16238945|NCT01093807|Drug|Lercanidipine + Enalapril|10/20 mg once daily for 10 weeks
16238946|NCT01093807|Drug|Lercanidipine + Enalapril|20/10 mg once daily for 10 weeks
16238947|NCT01093807|Drug|Lercanidipine + Enalapril|20/20 mg once daily for 10 weeks
16238948|NCT01093794|Drug|Co-administration of 50 mg sitagliptin and 500 mg metformin|Co-administration of 50 mg sitagliptin and 500 mg China-sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met500) after fasting for at least 10 hours.
16238949|NCT01093794|Drug|sitagliptin/metformin 50 mg/500 mg tablet|Single dose administration of the final marketing image (FMI) sitagliptin/metformin 50 mg/500 mg fixed-dose combination (FDC) tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours.
16238950|NCT01093794|Drug|Co-administration of 50 mg sitagliptin and 850 mg metformin|Co-administration of 50 mg sitagliptin and 850 mg China sourced metformin as individual tablets with 240 ml water on Day 1 of the relevant treatment period (Sit + Met850) after fasting for at least 10 hours.
16238951|NCT01093794|Drug|sitagliptin/metformin 50 mg/850 mg tablet|Single dose administration of the FMI sitagliptin/metformin 50 mg/850 mg FDC tablet with 240 ml water on Day 1 of the relevant treatment period (SitMet850 FDC) after fasting for at least 10 hours.
16238952|NCT01093781|Drug|Aliskiren|Aliskiren dose will begin with 150mg per day and later up-titrated to the maximum available dose of 300mg per day.
16238953|NCT01093768|Drug|Oxytocin|
16238954|NCT01093768|Drug|Vasopressin|
16238955|NCT01093755|Drug|dexlansoprazole|Intensive acid suppression with dexlansoprazole 60-90 mg/day for 6 months
16238956|NCT01093755|Drug|Omeprazole|Escalating doses of omeprazole (20-60 mg/day) for 6 months
16238957|NCT01093742|Drug|HM10560A|Subcutaneously administrate at 0 hour on Day 1
16238958|NCT01093742|Drug|Placebo|Placebo
16238959|NCT01093729|Drug|HM11260C|HM11260C 0.5mcg/kg or Placebo
16238960|NCT01093729|Drug|HM11260C|HM11260C 2mcg/kg or Placebo
16238961|NCT01093729|Drug|HM11260C|HM11260C 4mcg/kg or Placebo
16238962|NCT01093729|Drug|HM11260C|HM11260C 8mcg/kg or Placebo
16238963|NCT01093729|Drug|HM11260C|HM11260C 14mcg/kg or Placebo
16238964|NCT01093716|Device|Magstim Rapid® (rTMS)|Ten daily sessions of rTMS treatments using Magstim Rapid® device (10 Hz, 110% of the MT, 4.9 seconds per train, inter-train interval of 30 seconds, and 20 trains per session) with an air cooled figure-of-eight coil over either right or left DLPFC
16240547|NCT01081483|Drug|Placebo|See arm description for more information
16238965|NCT01093703|Other|Medication Adjustment|"Awake SBP≤135/85mmHg and patient is on once daily medications: Switch BP medications to pm period.
~Awake SBP SBP≤135/85mmHg and patient is on bid medications (e.g. metoprolol bid): Increase pm dose of the medication. If medication is already is at maximal dose or there is contraindication for increasing the dose (e.g. bradycardia), add another BP medicine in the evening time.
~Awake SBP≤135/85mmHg and patient is not on anti-hypertensive medications: Add BP medication at the pm period.
~Awake SBP>135/85mmHg: increase dose of antihypertensive medications or add more medications. All medications to be given in the evening time."
16238966|NCT01093690|Drug|metoclopramide|ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus metoclopramide 20 mg oral four times a day on day 2-5
16238967|NCT01093690|Drug|placebo|ondansetron 8 mg orally twice a day on days 2-5 and dexamethasone 8 mg orally twice a day on days 2-4 plus placebo 20 mg oral four times a day on day 2-5
16238968|NCT01093677|Drug|LIM-0705|Oral solution 750 mg LIM 0705 BID for 14 days.
16238969|NCT01093677|Drug|Placebo|Oral solution placebo BID for 14 days.
16238970|NCT01093664|Biological|AFFITOPE AD02|s.c. injection
16238971|NCT01093651|Drug|Sitagliptin|100 mg sitagliptin daily for 4-6 months
16238972|NCT01093651|Drug|Placebo|Daily placebo for 4-6 months
16238973|NCT01093638|Biological|Oral Formulation of Insulin|Oral formulation of insulin fed concomitantly with infant formula
16238974|NCT01093638|Biological|Placebo|Oral formulation of placebo fed concomitantly with infant formula
16238975|NCT01093625|Device|Narafilcon B Contact Lens|
16238976|NCT01093625|Device|Spectacles|spectacle wearers
16238977|NCT01093612|Procedure|positron emission tomography|PET images performed on a GE Discovery 16 Ste PET-CT scanner
16238978|NCT01093612|Radiation|copper Cu 64-DOTA-trastuzumab|15 mCi of Cu 64-DOTA-trastuzumab, total trastuzumab dose less than 5 mg.
16238979|NCT01093612|Procedure|Biopsy|Correlative Studies
16238980|NCT01093612|Other|Immunohistochemistry staining method|Correlative studies
16238981|NCT01093612|Other|laboratory biomarker analysis|Correlative studies
16238982|NCT01093612|Genetic|mutation analysis|Correlative studies
16238983|NCT01093599|Behavioral|Quit Line plus MTS|This provides the quit line intervention plus the Mindfulness for Smokers Intervention.
16238984|NCT01093599|Behavioral|Quit Line Only|The quit line only intervention includes phone counseling, Quit Smoking Materials and 4 weeks of nicotine patches.
16238985|NCT01093586|Procedure|double-unit umbilical cord blood transplantation|Undergo transplantation
16238986|NCT01093586|Other|cytogenetic analysis|Correlative studies
16238987|NCT01093586|Procedure|bone marrow aspiration|Correlative studies
16238988|NCT01093586|Other|fluorescence in situ hybridization|Correlative studies
16238989|NCT01093586|Drug|busulfan|Given orally
16238990|NCT01093586|Drug|cyclophosphamide|Given IV
16238991|NCT01093586|Drug|anti-thymocyte globulin|Given IV
16238992|NCT01093586|Drug|methylprednisolone|Given IV
16238993|NCT01093586|Drug|cyclosporine|Given IV
16238994|NCT01093586|Drug|mycophenolate mofetil|Given orally or IV
16238995|NCT01093586|Other|flow cytometry|Correlative studies
16238996|NCT01093586|Procedure|allogeneic hematopoietic stem cell transplantation|Undergo transplantation
16238997|NCT01093573|Drug|midostaurin|Given orally
16238998|NCT01093573|Drug|azacitidine|Given IV
16238999|NCT01093573|Other|bone marrow aspiration|Correlative study: Pretreatment bone marrow aspirates or blood [(3 ml in EDTA tube (purple top)] will be analyzed according to local institution guidelines to determine whether blasts contain wild type Flt3, ITD, or Flt 3 mutations.
16239000|NCT01093573|Other|mutation analysis|Correlative study
16239001|NCT01093573|Other|Pharmacokinetic study|Correlative study: Concentrations of unchanged midostaurin and its major metabolites, CGP52421 and CGP62221 in plasma samples will be determined using a validated liquid chromatography / mass spectrometry method.
16239002|NCT01093560|Dietary Supplement|fat feeding|Each feeding will consist of 473 mL of nonfat milk and 50 gms oil. The oil will be high in saturated fat, monounsaturated fat or polyunsaturated fat.
16239003|NCT01093547|Procedure|Blood samples|Samples taken monthly
16239004|NCT01093547|Procedure|Measure of peritoneal ultrafiltrates|Measured by the investigators intermittently and by the patients themselves on a monthly basis
16239005|NCT01093534|Drug|Placebo|Matching solifenacin placebo tablet
16239006|NCT01093534|Drug|solifenacin|Tablet for oral administration
16239007|NCT01093521|Drug|100 mg/m2 dose|5 day infusion of gallium nitrate (IV Ganite®) at a dose of 100 mg/m2/day
16239008|NCT01093521|Drug|200 mg/m2 dose|5 day infusion of gallium nitrate (IV Ganite®) at 200 mg/m2/day
16239009|NCT01093508|Drug|APD916|
16239010|NCT01093495|Device|CPAP|CPAP
16239011|NCT01093495|Device|Nasal Cannula|Nasal Cannula
16239012|NCT01093469|Drug|Atopiclair Nonsteroidal Cream|
16239013|NCT01093469|Other|Aquaphor Healing Ointment|
16239014|NCT01093469|Drug|EpiCeram|
16239015|NCT01093443|Drug|ovarian stimulation|rFSH with GnRH antagonists
16239016|NCT01093443|Drug|ovarian stimulation|GnRH antagonist, rFSH, GnRH antagonist
16239017|NCT01093430|Procedure|Anterior superior iliac spine|The position of the right and left laparoscopic port sites will be determined by palpation of the nearby anterior superior iliac spine of the pelvic bone.
16239018|NCT01093430|Procedure|Control|The position of the right and left laparoscopic port sites will be determined by visual inspection of the anterior abdominal wall.
16239019|NCT01093417|Drug|Vitamin D|Vitamin D 4000 IU will be administered to enrollees on the active comparator arm
16239020|NCT01093417|Other|Placebo|Placebo pills will be administered to enrollees in this arm
16239021|NCT01093404|Procedure|Thrombus aspiration|Aspiration of thrombus material before angioplasty
16239176|NCT01092247|Other|Nutritional intervention with the Ketogenic diet|Nutritional intervention with ketogenic diet. The Diet plan will be based on each patient individually according to his nutritional needs. Age, weight, activity levels, culture and food preferences are taken in consideration
16239177|NCT01092234|Other|Traditional ward|provision of care in a traditional unit/ward.
16240548|NCT01081457|Device|Deep brain stimulation|Comparison ON vs OFF
16239022|NCT01093391|Device|DRUG ELUTING STENT|Site preparation and percutaneous access should be performed as per standard hospital procedures.It is recommended to cross the target lesion with 0.014-inch exchange-length guide wire. The involved lesion should be predilated with appropriately sized balloons using standard techniques. It is strongly encouraged that the Investigators use similar materials and techniques throughout the study to maintain consistency and standardization of care.A stent consists of an endovascular prosthesis with a metallic mesh structure that is implanted at the site of the artery blockage via catheterization procedure. The objective of stenting is to obtain an angiographic appearance of the expanded stent only outside the limits of the target vessel filled with contrast medium.
16239023|NCT01093391|Device|BARE METAL STENT|Site preparation and percutaneous access should be performed as per standard hospital procedures.It is recommended to cross the target lesion with 0.014-inch exchange-length guide wire. The involved lesion should be predilated with appropriately sized balloons using standard techniques. It is strongly encouraged that the Investigators use similar materials and techniques throughout the study to maintain consistency and standardization of care.A stent consists of an endovascular prosthesis with a metallic mesh structure that is implanted at the site of the artery blockage via catheterization procedure. The objective of stenting is to obtain an angiographic appearance of the expanded stent only outside the limits of the target vessel filled with contrast medium.
16239024|NCT01093365|Drug|Varenicline|"0.0 mg orally twice per day for three days (placebo)
~0.5 mg orally twice per day for three days
~1.0 mg orally twice per day for three days"
16239025|NCT01093352|Procedure|Alveolar-decortication.|Following surgical exposure of the impacted tooth, the surgeon will prepare small holes (perforations) and/or grooves in the cortical bone surrounding the exposed tooth as well as in the buccal bone.
16239026|NCT01093326|Drug|Ponesimod 10 mg|Ponesimod 10 mg oral use
16239027|NCT01093326|Drug|Ponesimod 20 mg|Ponesimod 20 mg oral use
16239028|NCT01093326|Drug|Ponesimod 40 mg|Ponesimod 40 mg oral use
16239029|NCT01093313|Behavioral|Cognitive therapy|
16239030|NCT01093313|Behavioral|attention training|
16239031|NCT01093300|Device|Paclitaxel-eluting balloon catheter|
16239032|NCT01093300|Device|Everolimus-eluting stent|
16239033|NCT01093274|Drug|Sodium Picosulphate|2 Sachets
16239034|NCT01093274|Drug|Polyethylene Glycol|3 Liters solution
16239035|NCT01093261|Drug|Placebo|"Placebo:
~continuous intra venous infusion of placebo n°1 for 10 days. enteral administration of placebo n°2 for 10 days."
16239036|NCT01093261|Drug|Hydrocortisone Fludrocortisone|HYDROCORTISONE: 200 mg.day-1 for 7 days, 100 mg.day-1 on day 8 and 9, 50 mg on day-10 (continuous intravenous infusion) FLUDROCORTISONE: 50 microg.day-1 for 10 days (per os)
16239037|NCT01093235|Biological|bevacizumab|
16239038|NCT01093235|Drug|cyclophosphamide|
16239039|NCT01093235|Drug|docetaxel|
16239040|NCT01093235|Drug|epirubicin hydrochloride|
16239041|NCT01093235|Drug|fluorouracil|
16239042|NCT01093235|Procedure|assessment of therapy complications|
16239043|NCT01093235|Procedure|neoadjuvant therapy|
16239044|NCT01093235|Procedure|quality-of-life assessment|
16239045|NCT01093235|Procedure|therapeutic conventional surgery|
16239046|NCT01093222|Drug|Erlotinib Hydrochloride|Given PO
16239047|NCT01093222|Drug|Sorafenib Tosylate|Given PO
16239048|NCT01093209|Device|Interferential Laser Therapy|PROCEDURE: Interventional group: Two independents and identical probes. Energy dose per point and per probe: 5 J. Continuous emission. Treatment time:8 minutes. Sessions: 10. Frequency of the sessions: daily. Irradiation technique: handily, in contact and at 7 points over distal pathway of median nerve.Control group: Sham laser:650 nm.Scanning mode.Outpout power:1 mW.
16239049|NCT01093196|Drug|Melphalan, Prednisone, Lenalidomide|"Induction: 9 courses every 28 days - oral Lenalidomide for 21 days followed by a 7 days rest period; oral Melphalan for 4 days, followed by a 24 days rest period [different doses according to the age of patients (65-75 or >75 years old);oral Prednisone for 4 days followed by a 24 day rest period.
~Maintenance: ARM A1, B1 and C1 - oral Lenalidomide on day 1-21 followed by a 7 days rest period.
~ARM A2,B2 and C2:oral Lenalidomide on day 1-21 followed by a 7 days rest period and oral Prednisone every other day.Each cycle will be repeated every 28 days, until any sign of disease progression(PD)."
16239050|NCT01093196|Drug|Cyclophosphamide, Prednisone, Lenalidomide|Induction: 9 cycles every 28 days:Lenalidomide will be given orally at the dose of 25 mg/day for 21 days followed by a 7 days rest period (day 22 to 28;Cyclophosphamide will be given orally at the dose of 50 mg /day for 21 days followed by a 7 day rest period (days 1 to 28) in patients 65-75 years old and 50 mg every other day (days 1 to 20 followed by a 8 days rest period [day 21 to 28]) in patients older than 75 years.Prednisone will be given orally at the dose of 25 mg every other day (days 1 to 28.Each cycle will be repeated every 28 days, until any sign of disease progression(PD).
16239051|NCT01093196|Drug|Lenalidomide, dexamethasone|Induction: 9 course every 28 days-Lenalidomide will be given orally at the dose of 25 mg/day for 21 days followed by a 7 days rest period (day 22 to 28); Dexamethasone will be given orally at the dose of 40 mg on days 1, 8, 15 and 22 every 28 days in patients 65-75 years old and at the dose of 20 mg on days 1,8,15 and 22 every 28 days in patients older than 75 years. Maintenance:After 2-3 months from the completion of the last induction cycle, patients will start maintenance therapy according to physician willing and general dose-reduction rules.ARM A1, B1 and C1:Lenalidomide will be given at the dose of 10 mg/day on day 1-21 followed by a 7 days rest period. ARM A2, B2 and C2:Lenalidomide will be given at the dose of 10 mg/day on day 1-21 followed by a 7 days rest period; Prednisone will be given orally at the dose of 25 mg every other day (days 1 to 28) Each cycle will be repeated every 28 days, until any sign of disease progression (PD).
16239052|NCT01093183|Drug|lenalidomide|Given PO
16239053|NCT01093183|Drug|cyclophosphamide|Given PO
16239054|NCT01093183|Other|laboratory biomarker analysis|Correlative studies
16239055|NCT01093183|Other|questionnaire administration|Ancillary studies
16239056|NCT01093183|Other|quality-of-life assessment|Ancillary studies
16239057|NCT01093170|Drug|RNA-144101|Intravitreous administration of RNA-144101
16239178|NCT01092234|Other|Organizational change|Observational unit (new organizational unit) for organizing in-hospital care
16239179|NCT01092221|Drug|Allopurinol|Allopurinol 1 capsule 300 mg, BID
16239180|NCT01092221|Drug|Placebo|Placebo 1 capsule, 300 mg, BID
16239181|NCT01092195|Biological|Gardasil|3 separate 0.5 ml intramuscular
16239058|NCT01093157|Drug|Adrenocorticotrophic hormone ACTH|There will be two arms to the study: one arm receive 40 units and the second arm 80 units of the ACTH gel subcutaneously both given in a dose escalating frequency beginning at once every two weeks escalating to a maximum of twice per week over a total of three months exposed.An ammendment(approved by Health Canada and the UHN IRB allows an additional 1 month of the perscribed therapy of ACTH )if there is an improvement in proteinuria at the end of the 3 month exposure.
16239059|NCT01093144|Device|pelvic measurements using the LaborPro Device|pelvic measurements using the LaborPro Device,ultrasound non invasive measurements
16239060|NCT01093131|Other|Oral hydration|Oral hydration with 500 mL of water to be started 4 hours prior to contrast exposure and stopped 2 hours prior to procedure followed by oral hydration with 600 mL of water post procedure
16239061|NCT01093131|Drug|Oral sodium bicarbonate|Oral hydration with 500 mL of water to be started 4 hours prior to procedure and stopped 2 hours prior to contrast exposure, with the addition of 3.9 grams (46.4 mEq) of oral sodium bicarbonate to be given 20 minutes prior to contrast exposure followed by 1.95 grams (30.4 mEq) of oral sodium bicarbonate 2 hours and 4 hours after the initial dose
16239062|NCT01093131|Other|Intravenous Hydration|Pretreatment with a 3 mL/kg bolus of intravenous normal saline solution (154 mEq/L) over 1 hour, immediately prior to contrast exposure followed by intravenous infusion of 1ml/kg per for 6 hours after the procedure.
16239063|NCT01093131|Drug|Intravenous sodium bicarbonate|Pretreatment with a 3 mL/kg bolus of intravenous sodium bicarbonate solution (154 mEq/L) over 1 hour, immediately prior to contrast exposure followed by intravenous infusion of 1 mL/kg for 6 hours after the procedure.
16239064|NCT01093118|Drug|TMI-358|Micro implant monthly x 3
16239065|NCT01093118|Drug|MMI-467|Micro implant monthly x 3
16239066|NCT01093092|Dietary Supplement|Calcitriol|Given PO
16239067|NCT01093092|Drug|Cisplatin|Given IV
16239068|NCT01093092|Drug|Gemcitabine Hydrochloride|Given IV
16239069|NCT01093092|Other|Pharmacological Study|Correlative studies
16239070|NCT01093079|Procedure|Laparoscopic partial nephrectomy|Laparoscopic partial nephrectomy
16239071|NCT01093079|Procedure|Open partial nephrectomy|Open partial nephrectomy
16239072|NCT01093066|Drug|optimal TURB|The TURB will always try to be optically complete.
16239073|NCT01093053|Behavioral|Mind-Body Skills Groups|The mind-body skills group program teaches participants how to do meditation, guided imagery, breathing techniques, and biofeedback. These mind-body techniques are taught and practiced in small groups of 8 to 10 people and also contain an element of social support.
16239074|NCT01093053|Other|Standard Treatment|May include individual or group psychotherapy consisting of cognitive behavioral therapy or present-centered (i.e. unrelated to mindfulness) psychotherapy as well as medication management. Medications for depression, anxiety, and sleep disorders are the most commonly used in standard treatment.
16239075|NCT01093040|Drug|CAT-354|150 mg CAT-354 or placebo given SC on Day 1
16239076|NCT01093040|Drug|CAT-354|300 mg CAT-354 or placebo given SC on Day 1
16239077|NCT01093040|Drug|CAT 354|600 mg CAT-354 or placebo given SC on Day 1
16239078|NCT01093027|Other|15 - 30|The upper limb with tremor will be cooled with 15 degrees Celsius water for 10 minutes at Visit 1 and with 30 degrees Celsius water for 10 minutes at Visit 2.
16239079|NCT01093027|Other|30 - 15|The upper limb with tremor will be cooled with 30 degrees Celsius water for 10 minutes at Visit 1 and with 15 degrees Celsius water for 10 minutes at Visit 2.
16239080|NCT01093014|Behavioral|Low-force muscle stimulation|Electrical stimulation of paralyzed muscle in seated or standing to evoke non-summated, low-force contractions, using either a lab-based system or a portable system for up to 1 year.
16239081|NCT01093014|Behavioral|High-force muscle stimulation|Electrical stimulation of paralyzed muscle in seated or standing to evoke summated, high-force contractions, using either a lab-based system or a portable system for up to 1 year.
16239082|NCT01093014|Behavioral|Sequential low-force and high-force muscle stimulation|Electrical stimulation of paralyzed muscle in seated or standing to evoke non-summated, low-force contractions, followed by: 1) a 1-month washout period, then; 2) electrical stimulation to evoke summated, high-force contractions.
16239083|NCT01093001|Other|Echo|Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation.
16239084|NCT01093001|Other|Echo|Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation
16239085|NCT01093001|Other|Echo|Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation.
16239086|NCT01093001|Other|Echo|Two dimensional echocardiography will be performed to reassess Tricuspid Regurgitation.
16239087|NCT01092988|Device|Exablate 2100|MR guided focused ultrasound
16239088|NCT01092975|Drug|phenylephrine solution|Subjects will receive up to 40 dose of topical phenylephrine at the specified dose level.
16239089|NCT01092962|Drug|Cyclophosphamide|2mg/kg/day during 12 weeks (cumulative dose 148mg/kg)
16239090|NCT01092962|Drug|Mycophenolate mofetil|1200mg/m²/jour in two divided doses during 18 months
16239091|NCT01092949|Device|MRI|MRI, 45 minutes
16239092|NCT01092936|Other|Rating Scale administration|Movement Disorder Society_Unified Parkinson's Disease Rating Scale will be submitted to the patient (with the help of the caregiver) in a single visit lasting about 40 minutes.
16239093|NCT01092923|Drug|sevoflurane on air/O2|sevoflurane on air/O2
16239094|NCT01092923|Drug|sevoflurane in N2O/O2|sevoflurane in N2O/O2
16239095|NCT01092910|Device|Esteem Totally Implantable Hearing System|The Esteem System is a totally implantable hearing system designed to improve hearing in adult subjects suffering from mild to severe hearing loss that is sensorineural in origin.
16239096|NCT01092884|Dietary Supplement|Polypodium leucotomos extract|240 mg capsule of Polypodium leucotomos extract will be taken orally three times daily
16239097|NCT01092884|Other|Placebo|This placebo capsule will be taken orally three times daily
16239098|NCT01092858|Drug|Testosterone Undeconate (Nebido, BAY86-5037)|Testosterone undecanoate 1000 mg (4 ml) i.m. injection at baseline, at week 6, at week 18, at week 30 and at week 42, respectively
16239099|NCT01092858|Drug|Placebo|Matching placebo i.m. injections at baseline, at week 6, at week 18 at week 30 and at week 42, respectively
16239100|NCT01092845|Drug|PF-04457845 / matched placebo|PF-04457845 4 mg tablet once daily / matched placebo
16239102|NCT01092832|Drug|voriconazole|"Subjects 12 - <18 yrs (excluding subjects 12 - 14 yrs weighing <50kg): For IC, the loading dose is 6 mg/kg IV q12h on Day 1, followed by 4 mg/kg IV q12h thereafter. Oral therapy, if given, will be administered at a dose of 200 mg q12h. For EC, no loading dose is required, and subjects will be initiated on 3 mg/kg IV q12h. Oral therapy, if given, will be administered at a dose of 200 mg q12h.
~Subjects 2 - <12 yrs, and subjects 12 - 14 weighing <50kg: For IC, the loading dose is 9 mg/kg IV q12h on Day 1, followed by 8 mg/kg IV q12h thereafter. For EC, no loading dose is required, and subjects will be initiated on 4 mg/kg IV q12. Oral therapy, if given, will be administered at a dose of 9 mg/kg q12h (maximum initial dose of 300 mg).
~Subjects will be treated for a minimum of 14 days for invasive candidiasis/candidemia or a minimum of 7 days for esophageal candidiasis. Subjects will be treated for up to a maximum of 42 days."
16239103|NCT01092819|Other|Current standard of care for acute ischemic stroke other than IV rtPA or other IA therapies|The objective of this study is to determine the natural history of acute ischemic stroke from large vessel thromboembolism in the brain. Patients with current standard of care other than IV rtPA or IA therapies will be studied.
16239104|NCT01092806|Drug|Tacrolimus|Two different formulations of the drug is compared. The dose is adjusted according to whole blood concentrations in accordance with center protocol. Switch between the two formulations are done by a 1:1 conversion of daily dose.
16239105|NCT01092793|Dietary Supplement|Krill|
16239106|NCT01092793|Dietary Supplement|Fish oil|
16239107|NCT01092780|Drug|MK-7288|one or two 10 mg capsules, orally, single dose
16239108|NCT01092780|Drug|Placebo to MK-7288|one or two capsules, orally, single dose
16239109|NCT01092780|Drug|Modafinil|two 100 mg tablets, orally, single dose
16239110|NCT01092780|Drug|Placebo to modafinil|two 100 mg tablets, orally, single dose
16239112|NCT01092754|Procedure|MRI|contrast enhanced MRI
16239113|NCT01092754|Procedure|MRI|contrast enhanced MRI
16239114|NCT01092754|Drug|Gadoversetamide|Subjects will receive a single dose of Optimark(0.1 mmol/kg)as a bolus thru a peripheral IV line at 1-2 mL/sec followed by a saline flush during their medically necessary MRI .
16239115|NCT01092741|Drug|Gleevec|400 mg P.O. twice daily (800 mg total daily dose)
16239116|NCT01092728|Drug|Dasatinib|100 mg daily.
16239117|NCT01092728|Procedure|Surgical Resection|Complete surgical resection of tumor(s).
16239118|NCT01092715|Procedure|Spinal mobilization|Non thrust mobilization to the cervical spine
16239119|NCT01092715|Procedure|Massage|Sedative massage to cervical paraspinal muscles
16239120|NCT01092715|Procedure|Neck exercises|Range of motion exercises to include foraminal opening
16239121|NCT01092702|Drug|Varenicline|During the first week varenicline will be started at a dose of 0.5 mg once daily for days 1-3; then 0.5 mg twice daily for days 4-7. Target quit date is set at day 8. Varenicline is then continued for weeks 2-12 at a dose of 1 mg twice daily.
16239122|NCT01092689|Drug|PhiP|1 capsule of 84 micrograms; 15.6 micro-curies [14C]PhIP
16239123|NCT01092676|Drug|Ibuprofen Regular Dosing|Regular dosing
16239124|NCT01092676|Drug|PRN dosing Ibuprofen|PRN dosing Ibupofen
16239125|NCT01092663|Drug|Colesevelam HCl|Subjects will be given 3.75 g/day. Subjects will be given 3 tablets (625mg each) with breakfast and 3 tablets (625mg) with dinner for 12 weeks.
16239126|NCT01092663|Drug|Sitagliptin|Subjects will be given 100mg/day. Subjects will be given 1 tablet (100mg) with breakfast for 12 weeks.
16239127|NCT01092650|Drug|Deuterated phenanthrene|Deuterated phenanthrene 10 micrograms
16239128|NCT01092624|Drug|Solifenacin|There will be a two-week pessary run-in prior to randomization. If the subject completes the run-in period with no adverse reactions to the pessary, she will come in to the office for a randomization visit. She will be randomized to receive either 5 mg/day (one 5 mg tablet QD) of placebo or 5 mg/day (QD) of solifenacin for 12 weeks. At the end of week 6, patients will be assessed in the office. A standardized medication response questionnaire will be used to assess each subject's response to either the placebo or the solifenacin 5 mg. If the response is not adequate, the dose will be increased. Women whose symptoms have not improved since baseline will have their medication or placebo doses increased to 10 mg daily.
16239129|NCT01092624|Drug|Placebo|There will be a two-week pessary run-in prior to randomization. If the subject completes the run-in period with no adverse reactions to the pessary, she will come in to the office for a randomization visit. She will be randomized to receive either 5 mg/day (one 5 mg tablet QD) of placebo or 5 mg/day (QD) of solifenacin for 12 weeks. At the end of week 6, patients will be assessed in the office. A standardized medication response questionnaire will be used to assess each subject's response to either the placebo or the solifenacin 5 mg. If the response is not adequate, the dose will be increased. Women whose symptoms have not improved since baseline will have their medication or placebo doses increased to 10 mg daily.
16239130|NCT01092624|Device|Ring pessary with support, Cooper Surgical, Trumbell, CT Ref # MXPRS03 non-latex|There will be a two-week pessary run-in prior to randomization. If the subject completes the run-in period with no adverse reactions to the pessary, she will come in to the office for a randomization visit. She will be randomized to receive either 5 mg/day (one 5 mg tablet QD) of placebo or 5 mg/day (QD) of solifenacin for 12 weeks. At the end of week 6, patients will be assessed in the office. A standardized medication response questionnaire will be used to assess each subject's response to either the placebo or the solifenacin 5 mg. If the response is not adequate, the dose will be increased. Women whose symptoms have not improved since baseline will have their medication or placebo doses increased to 10 mg daily.
16239131|NCT01092611|Procedure|Blood collection|Once a year after Visit 1 (during a maximum of 4 years). The samples will only be taken in conjunction with, and at the same time as, planned routine blood testing using the same needle-stick.
16239132|NCT01092611|Biological|GSK HIV vaccine 732462|No vaccine will be administered during this long-term follow-up study. Vaccines were administered during the primary studies.
16239184|NCT01092169|Other|No intervention|
16239185|NCT01092156|Behavioral|Education|Education on Infant-led latching
16239186|NCT01092143|Drug|BI671800|double blind randomized parallel group study
16239187|NCT01092143|Drug|BI671800|double blind randomized parallel group study
16239188|NCT01092143|Drug|BI 671800|double blind randomized parallel
16239133|NCT01092585|Drug|Tesetaxel|"Tesetaxel capsules will be administered orally once every 21 days until the patient meets a withdrawal criterion or initiates nonstudy therapy for melanoma. The duration of protocol therapy will not exceed 12 months.
~In Cycle 1, a flat dose of 40 mg will be administered to patients of relatively normal weight. For patients who weigh at least 25% below their ideal body weight, a flat dose of 35 mg will be administered. For patients who weigh at least 25% above their ideal body weight, a flat dose of 45 mg will be administered. Dose escalation by 5 mg in Cycle 2 and an additional 5 mg in Cycle 3 is permitted provided protocol-specified criteria are met."
16239134|NCT01092572|Drug|Simvastatin|simvastatin 40 mg per day orally for 12 weeks.
16239135|NCT01092572|Drug|placebo|placebo 1 tablet once daily for 12 weeks
16239136|NCT01092559|Drug|Nitric Oxide generated by the GeNO nitrosyl delivery system|single short-term exposure to inhaled nitric oxide using the GeNO nitrosyl delivery system.
16239137|NCT01092546|Drug|[18F]Flutemetamol|All subjects will receive an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.
16239138|NCT01092533|Drug|Myfortic|Myfortic 360 mg BID (during week 1) Myfortic 720 mg BID (from week 2 on) Maintenance dose Decortin 5mg/d
16239139|NCT01092533|Drug|Decortin|Maintenance dose 5 mg/d
16239140|NCT01092520|Drug|Gabapentin|Day 1 - 5mg/kg/dose per os at bedtime then 5mg/kg/dose PO b.i.d x 1 day (Day 2) then on Day 3, 5mg/kg/dose PO t.i.d . x 19 days; after 7 days, if not at maximal effect may increase over 3 days to 10mg/kg/dose (Day 8: 5 mg/kg/dose q.am and midday, Day 9: 10mg/kg/dose b.i.d. + 5mg/kg/dose midday, Day 10: 10mg/kg/dose t.i.d.) Doses may be reduced if patient experiences intolerable side effects.
16239141|NCT01092507|Biological|Japanese encephalitis chimeric virus vaccine (JE-CV)|0.5 mL, Subcutaneous
16239142|NCT01092507|Biological|Japanese encephalitis live vaccine (SA14-14-2 vaccine) (CD.JEVAX®)|0.5 mL, Subcutaneous
16239143|NCT01092481|Drug|oxaliplatin|to confirm that first 3 months of oxaliplatin in 12 cycles of modified FOLFOX-6 or 8 cycles of CAPOX treatment is not inferior to 6 months of oxaliplatin in modified FOLFOX-6 or CAPOX treatment in terms of disease free survival in patients with stage II/III colon cancer.
16239144|NCT01092468|Procedure|Diathermy|flap dissection with conventional diathermy
16239145|NCT01092468|Procedure|Harmonic Scalpel|flap dissection using harmonic scalpel (FOCUS)
16239146|NCT01092455|Drug|Heparin N reduction|Dialysis with Citrasate, acid concentrate plus 100% of patient's standard heparin N dose; Dialysis with Citrasate acid concentrate plus 80% of patient's standard heparin N dose; Dialysis with Citrasate acid concentrate plus 66.7% of patient's standard heparin N dose.
16239147|NCT01092442|Procedure|Echocardiogram|Patients will have a yearly echocardiogram after enrollment in the study.
16239148|NCT01092416|Device|Diamondback 360 Orbital Atherectomy System|Diamondback 360 Orbital Atherectomy System. The (OAS) utilizes a diamond-coated eccentric crown that, while rotating over an atherectomy guide wire, expands the lumen diameter laterally via centrifugal forces (up to a maximum orbit diameter for a given rotational speed and crown diameter). It is a minimally invasive PCI procedure.
16239149|NCT01092403|Drug|ASM-024|ASM-024 50 mg of ASM-024 or 200 mg once daily by inhalation
16239150|NCT01092403|Drug|Placebo|Placebo once daily by inhalation
16239151|NCT01092390|Dietary Supplement|Lovaza (fish oil)|4 grams per day
16239152|NCT01092377|Dietary Supplement|DHA and EPA Fish Oil capsule|2 DHA/EPA capsules on 4 days per week containing totally 420 mg DHA and 80 mg EPA, providing an average dose of 285.7 mg n-3 fatty acids per day
16239153|NCT01092377|Dietary Supplement|Iron tablet|1 iron tablet containing 50 mg of iron as ferrous sulfate will be administered on 4 days per week, providing an average iron dose of 28.6 mg iron per day.
16239154|NCT01092377|Other|Placebo tablet|Placebo tablet will be administered on 4 days per week and will be identical in appearance to the iron tablet.
16239155|NCT01092377|Other|Placebo capsule|Placebo capsules contain medium chain triglycerides and will be identical in appearance and total fat content to the DHA/EPA capsules.
16239156|NCT01092364|Behavioral|Behavioral weight loss intervention|Behavioral lifestyle intervention for weight loss, compared to advice-only control.
16239157|NCT01092351|Drug|Nitrofurantoin|100 mg retard capsules to be taken twice daily for seven days
16239158|NCT01092338|Drug|Cholecalciferol (Vit D3)|To test two oral daily doses (4000 vs. 7000 IU) of cholecalciferol (D3) dietary supplement (capsules or liquid) over a 3-month period in 44 children, adolescents and adults with HIV/AIDS.
16239159|NCT01092325|Drug|CXL-1020|Intravenous infusion of one of 3 active dosages of CXL-1020
16239160|NCT01092325|Drug|CXL-1020|Intravenous infusion of one of 3 active dosages of CXL-1020 at dosages higher than in Cohort 1
16239161|NCT01092325|Drug|Placebo for CXL-1020 Cohort 1|A 4 hour infusion of a IV solution containing 5% Dextrose in water (Sugar Water)
16239162|NCT01092325|Drug|Placebo for CXL-1020 Cohort 2|A 4 hour infusion of a IV solution containing 5% Dextrose in water (Sugar Water)
16239163|NCT01092325|Drug|CXL-1020 Dose for Echo Cohort A|A 4 hour fixed dose of CXL-1020 which was studied in Cohort 1 or 2 which was demonstrated to be safe and well tolerated and have some anticipated hemodynamic effect
16239164|NCT01092325|Drug|CXL-1020 Doses for Echo Cohort B|A 2 hour dose level of CXL-1020 which was studied in Cohort 1 or 2 which was demonstrated to be safe and well tolerated and have some anticipated hemodynamic effect followed by another higher 2 hour dose level of CXL-1020 which was studied in Cohort 1 or 2 which was demonstrated to be safe and well tolerated and have some anticipated hemodynamic effect
16239165|NCT01092312|Procedure|Vanguard Knee System with Signature Knee Guide|Use of Signature Knee Guide
16239166|NCT01092312|Procedure|Vanguard Knee System with conventional Instruments|Vanguard Knee System with conventional Instruments
16239167|NCT01092299|Drug|AZD1446|ER Fast, 90mg, p.o. capsule
16239168|NCT01092299|Drug|AZD1446|ER Moderate, 90mg, p.o. capsule
16239169|NCT01092299|Drug|AZD1446|ER Slow, 90mg, p.o. capsule
16239170|NCT01092299|Drug|AZD1446|MR
16239171|NCT01092299|Drug|AZD1446|IR, 90 mg p.o. capsule
16239172|NCT01092299|Drug|Placebo|IR
16239173|NCT01092299|Drug|Placebo|ER/MR
16239174|NCT01092286|Other|neuromuscular warm-up|neuromuscular warm-up exercises that take 20 minutes to perform
16239175|NCT01092247|Other|Nutritional support with Standard diet|Nutritional support with Standard diet
16241677|NCT01072201|Drug|Triclosan and Fluoride|Brush twice daily
16239190|NCT01092143|Drug|Fluticasone placebo|double blind randomized parallel
16239191|NCT01092143|Drug|Fluticasone placebo|double blind randomized parallel
16239192|NCT01092143|Drug|Fluticasone placebo|double blind randomized parallel
16239193|NCT01092143|Drug|Fluticasone|double blind randomized parallel
16239194|NCT01092143|Drug|BI 671800 Placebo|double blind randomized parallel
16239195|NCT01092143|Drug|BI 671800 Placebo|double blind randomized parallel
16239196|NCT01092130|Drug|Vitamin D|2000 IU vitamin D daily, for 6 weeks
16239197|NCT01092117|Device|Ovation™ Abdominal Stent Graft System|Implant of Ovation™ Abdominal Stent Graft System
16239198|NCT01092104|Drug|TBR-652|TBR-652 25 mg
16239199|NCT01092104|Drug|TBR-652 Matching Placebo|Matching Placebo
16239200|NCT01092104|Drug|TBR-652 50 mg|TBR-652 50 mg QD for 10 days
16239201|NCT01092104|Drug|TBR-652 75 mg|TBR-652 75 mg QD for 10 days
16239202|NCT01092104|Drug|TBR-652 100 mg|TBR-652 100 mg QD for 10 days
16239203|NCT01092104|Drug|TBR-652 150 mg|TBR-652 150 mg QD for 10 days
16239204|NCT01092091|Biological|Pegylated Recombinant Human Arginase I|Weekly dose of PEG-BCT-100 for at least 8 weeks (or until disease progression) at 1600U/kg
16239205|NCT01092078|Behavioral|MINT|Motivational interviewing for lifestyle changes associated with treating hypertension
16239206|NCT01092078|Behavioral|Patient Navigation|Patient navigation for colonoscopy.
16239207|NCT01092065|Drug|AFQ056 with L-dopa|hard gelatin capsule to be taken bid for six weeks
16239208|NCT01092065|Drug|Placebo|hard gelatin capsule to be taken bid for six weeks
16239209|NCT01092052|Drug|NMS-1116354|Oral daily administration for 14 consecutive days followed by 7 days of rest
16239210|NCT01092039|Dietary Supplement|lactoferrin, L-Glutamine and beta-glucans|Subject will be given XIGO pills or placebo. two tablets to be taken by mouth 3 times per day.
16239211|NCT01092039|Dietary Supplement|Placebo Comparator|Subject will be given placebo comparator of two tablets to be taken by mouth 3 times per day.
16239212|NCT01092026|Other|cord blood transplantation|One or two cord blood transplants with co-infusion of third-party mesenchymal stem cells after pre-transplant preparative regimen
16239213|NCT01092013|Behavioral|Training on laparoscopic simulator in skills lab|Laparoscopic camera training in a skills lab following training protocol for a total of 6 hours during 3 weeks.
16239214|NCT01092013|Behavioral|Training at actual laparoscopic surgery|Assisting at 6 laparoscopic surgeries navigating the camera during 3 weeks
16239215|NCT01092013|Behavioral|Technical instruction|Technical instruction on proper handling of an angled laparoscope before randomization for 1 hour
16239216|NCT01092000|Behavioral|Monitoring|Each week participants are asked to record electronically their fruit intake, vegetable intake and minutes of physical activity.
16239217|NCT01092000|Other|Education|Monthly exercise tips handout.
16239218|NCT01091987|Behavioral|Non-pharmacological approach of insomnia|education on sleep, sleep hygiene, stimulus control, cognitive techniques
16239219|NCT01091974|Drug|armodafinil|Armodafinil P.O. daily/47 days (3-days at 50mg, then 40 days at 100mg, then 4 days at 50mg)
16239220|NCT01091974|Drug|Placebo Comparator|Placebo for 47 days
16239221|NCT01091974|Behavioral|CBT-I|Seven weekly sessions of cognitive behavioral therapy for insomnia (CBT-I)
16239223|NCT01091948|Device|Intubation with Fiberoptic laryngoscope|Subjects will be intubated with the Fiberoptic laryngoscope.
16239224|NCT01091948|Device|GlideScope® Video Laryngoscope|Patients will be intubated with the GlideScope® Video Laryngoscope.
16239225|NCT01091922|Dietary Supplement|Low flavanol cocoa beverage|23 mg of total flavanols from cocoa
16239226|NCT01091922|Dietary Supplement|High flavanol cocoa beverage|495 mg of total flavanols from cocoa
16239227|NCT01091909|Procedure|Dental extractions|All dental extractions were performed at an outpatient clinic at the USP Dental School. In addition, all extractions were performed under local anesthesia by the same experienced dentist, in accordance with the standards established by Peterson et al (2008).
16239228|NCT01091896|Drug|Bevacizumab|1.25 mg of bevacizumab (0.05 ml) 7 days before vitrectomy
16239229|NCT01091896|Drug|bevacizumab|1.25 mg of bevacizumab (0.05 ml) at the end of vitrectomy
16239230|NCT01091883|Device|Exablate treatment|MR Guided Focused Ultrasound
16239231|NCT01091883|Radiation|Radiation|External Beam Radiation
16239232|NCT01091870|Drug|Placebo|Soluble blue pigment, 3 times a day, from the third to the 14th day after subarachnoid hemorrhage.
16239233|NCT01091870|Drug|Sildenafil Citrate, 25 mg, 3 times a day.|Sildenafil Citrate 25 mg, 3 times a day (TID)from the third to the 14 day after subarachnoid hemorrhage.
16239234|NCT01091870|Drug|Sildenafil Citrate 50 mg, 3 times a day|Sildenafil Citrate 25 mg, 3 times a day (TID)from the third to the 14 day after subarachnoid hemorrhage.
16239235|NCT01091857|Behavioral|STRIDE|
16239236|NCT01091844|Procedure|Voiding Trial|After surgery, each woman will undergo a voiding trial to assess for urinary retention after surgery. This is performed on all patients undergoing surgery involving prolapse or incontinence. There are two methods commonly used to perform a voiding trial: Spontaneous Fill and Retrograde Fill techniques. Both are considered standard of care. The goal of the study is to perform both on each patient to assess their equivalency. There are no experimental interventions taking place.
16239237|NCT01091831|Drug|Cyclophosphamide|Cyclophosphamide will be given orally at the dose of 300 mg/m2 on days 1, 8, 15 for 6 cycles every 28 days
16239238|NCT01091831|Drug|Lenalidomide|Lenalidomide will be given orally at the dose of 25 mg/d for 21 days followed by a 7 days rest period (day 22 to 28)for 6 cycles every 28 days
16239239|NCT01091831|Drug|Dexamethasone|Dexamethasone will be given orally at the dose of 40 mg on days 1, 8, 15, 22 for 6 cycles every 28 days
16239240|NCT01091831|Drug|Melphalan|Melphalan will be given iv at the dose of 200 mg/m2 for 1 day followed by stem cell support. The second MEL200 was performed 120 days after the first if ≤ PR was achieved after the 1st MEL200.
16239241|NCT01091818|Drug|dexmedetomidine|Dexemedethomidine is given as major sedative drug
16239242|NCT01091818|Drug|Midazolam|Midazolam is given as major sedative drug
16239243|NCT01091792|Drug|Bevacizumab|Bevacizumab every 2 weeks 10mg/kg beginning 2 weeks after start of Radiation Therapy
16239244|NCT01091766|Drug|intravenous injection of test solution|test dose consists of 0.2 ml/kg body weight test solution of the assigned drug
16239245|NCT01091766|Drug|intravenous injection of test solution|test dose consists of 0.2 ml/kg body weight test solution of the assigned drug
16239246|NCT01091766|Drug|intravenous injection of test solution|test dose consists of 0.2 ml/kg body weight test solution of the assigned drug
16239247|NCT01091753|Drug|Valsaltan, amlodipine|nti hypertensive medication time (nocturnal administration vs morning administration
16239248|NCT01091740|Device|ZES resolute (Endeavor Resolute)|2nd generation drug eluting stent, which is coated with zotarolimus
16239249|NCT01091740|Device|EES (Xience)|2nd generation drug eluting stent, which is coated with everolimus
16239250|NCT01091727|Drug|Botulinum toxin A|Comparison of intra-detrusor injection of 300U of Botulinum toxin A versus placebo for effect on neurogenic detrusor overactivity and urinary incontinence.
16239251|NCT01091714|Dietary Supplement|Omega-3|Approximately 2400 mg of Omega-3s taken once daily by capsule, taken for the duration of the study.
16239252|NCT01091714|Dietary Supplement|Omega-3|Approximately 2240 mg of Omega-3s taken once daily by capsule, taken for the duration of the study.
16239253|NCT01091714|Dietary Supplement|Omega-3|Approximately 2332 mg of Omega-3s taken once daily by capsule, taken for the duration of the study.
16239254|NCT01091701|Biological|Ex vivo cultured adult allogenic MSCs|Single IV dose of allogenic MSCs
16239255|NCT01091701|Other|Plasmalyte-A|Single IV dose of Plasmalyte-A
16239256|NCT01091688|Behavioral|Just-in-Time information|Infants and physicians assigned to the intervention group will receive Just-in-Time information at the time of NICU discharge, by email and facsimile, and the parents will receive a copy to bring to their first clinic appointment.
16239257|NCT01091675|Drug|Etoricoxib|Etoricoxib 90 mg/day/PO during 4 weeks Positive response to the therapy (in investigator opinion): Ongoing treatment with 90 mg/day/PO until 24 weeks.
16239258|NCT01091662|Drug|Eslicarbazepine acetate 1600 mg|1600 mg once per day
16239259|NCT01091662|Drug|Eslicarbazepine acetate 1200 mg|1200 once per day
16239260|NCT01091649|Drug|ABT-450|Low dose ABT-450 / ritonavir see Arm Description for more information
16239261|NCT01091649|Drug|ritonavir|ritonavir see Arm Description for more information
16239262|NCT01091649|Drug|ABT-450|High dose ABT-450 / ritonavir See Arm Description for more information
16239263|NCT01091636|Procedure|Hyperthermic Intraperitoneal Chemotherapy|41.5 oC injected into the perfusion cisplatin (75 mg/m2)during 90min
16239264|NCT01091623|Other|training|
16239265|NCT01091623|Other|training|
16239266|NCT01091623|Other|training|
16239267|NCT01091610|Other|no intervention|purely observational retrospective study. no interventions are planned.
16239268|NCT01091597|Procedure|usual PV ablation|usual PV ablation, per above
16239269|NCT01091597|Procedure|Box isolation of pulmonary veins|as above
16239270|NCT01091584|Device|distress thermometer|to apply the distress thermometer as written in the guideline written by 'Vereniging Integrale Kankercentra' title: 'Detecteren behoefte psychosociale zorg. The distress thermometer is collected from the experimental group and then discussed by a trained nurse
16239271|NCT01091571|Drug|Dipyridamole|Oral treatment with dipyridamole 200 mg twice daily during seven consecutive days
16239272|NCT01091571|Drug|Placebo|Placebo twice daily during seven consecutive days
16239273|NCT01091571|Other|LPS|The LPS derived from E. coli O:113 2ng/kg iv will be injected in 1 minute at a dosage of 2 ng/kg body weight.
16239274|NCT01091545|Radiation|DBT and FFDM|Women in the study will once undergo both standard FFDM screening (2-views) and DBT (1 view, MLO). This will result in a doubled radiation dose compared to only 2-view FFDM, which is the standard procedure for women in the screening program.
16239275|NCT01091532|Drug|UK-396,082|"100mg given orally twice daily for 14 days
~The decision to proceed to the next higher dose will be made jointly by the Pfizer Study Team and the Investigator after careful review of available safety, tolerability and PK information from previous cohorts and dosing periods. The doses will be selected such that the predicted Cmax will not exceed 2.95 mcg/mL and/or the predicted increase in exposure will not exceed 3.5-fold that of the previously studied dose."
16239276|NCT01091532|Drug|placebo|given orally twice daily for 14 days
16239277|NCT01091532|Drug|UK-396,082|"300mg given orally twice daily for 14 days
~The decision to proceed to the next higher dose will be made jointly by the Pfizer Study Team and the Investigator after careful review of available safety, tolerability and PK information from previous cohorts and dosing periods. The doses will be selected such that the predicted Cmax will not exceed 2.95 mcg/mL and/or the predicted increase in exposure will not exceed 3.5-fold that of the previously studied dose."
16239278|NCT01091532|Drug|placebo|given orally twice daily for 14 days
16239279|NCT01091532|Drug|UK-396,082|"1000mg given orally twice daily for 14 days
~The decision to proceed to the next higher dose will be made jointly by the Pfizer Study Team and the Investigator after careful review of available safety, tolerability and PK information from previous cohorts and dosing periods. The doses will be selected such that the predicted Cmax will not exceed 2.95 mcg/mL and/or the predicted increase in exposure will not exceed 3.5-fold that of the previously studied dose."
16239280|NCT01091532|Drug|placebo|given orally twice daily for 14 days
16239281|NCT01091532|Drug|UK-396,082|"UK-396,082 given orally, once on Days 1 & 14, and twice daily on Days 3-13.
~The decision to proceed to the next higher dose will be made jointly by the Study Team and the Investigator after careful review of available safety, tolerability and PK information from previous cohorts. Dependent on the emerging safety, tolerability and PK data, Cohort 4 may be recruited to study a higher (or lower) dose of UK-396,082 in order to characterize further the safety, toleration and PK and/or to define the maximum tolerated dose. The dose in Cohort 4 will be selected such that the predicted Cmax will not exceed 46 mcg/mL and/or the predicted increase in exposure will not exceed 3.5-fold that of the previously studied dose."
16239282|NCT01091532|Drug|placebo|given orally, once on Days 1 & 14, and twice daily on Days 3-13.
16239283|NCT01091519|Other|Toviaz(fesoterodine) plus educational materials|Educational materials including the Self-Assessment Goal Achievement (SAGA) tool to support dialogue.
16239284|NCT01091519|Other|Toviaz(fesoterodine) without educational materials|No educational materials
16239286|NCT01091506|Other|L-methylfolate|L-methylfolate 15mg once a day for 12 weeks
16239287|NCT01091493|Drug|Moxifloxacin|Moxifloxacin 400 mg administered once a day for 5 days
16239288|NCT01091454|Drug|brostallicin|Given IV
16239289|NCT01091454|Drug|cisplatin|Given IV
16239290|NCT01091428|Drug|Alisertib|Alisertib tablets
16239291|NCT01091428|Drug|Paclitaxel|Paclitaxel intravenous infusion
16239292|NCT01091415|Procedure|calcium phosphate bone cement injection|volar locking plate alone versus calcium phosphate bone cement as well as volar locking plate
16239293|NCT01091402|Procedure|autologous serum skin test, serum IL-18|
16239294|NCT01091389|Procedure|Totally Thoracoscopic PV isolation|Surgery is performed through three ports bilaterally in the intercostal spaces. PVI is performed with a bipolar radiofrequency clamp and confirmed with a custom made multi-electrode probe with closely spaced (1mm) electrode terminals. Additional left atrial ablation lines are created and conduction block is verified in patients with persistent and permanent AF.
16239295|NCT01091376|Drug|Erlotinib|Erlotinib 150mg/day
16239296|NCT01091376|Radiation|Thoracic radiotherapy|60-70Gy/30-35f
16239297|NCT01091363|Behavioral|Standard|10 minute brief cessation counseling
16239298|NCT01091363|Behavioral|Deep Cultural|Deep culturally tailored cognitive behavioral therapy
16239299|NCT01091350|Device|Diprifusor (Target-controlled infusion)|Two TCI devices with different Teo and same Marsh PK model
16239300|NCT01091350|Device|Orchestra (Target-controlled infusion)|Two TCI devices with different Teo and same Marsh PK model
16239301|NCT01091337|Drug|Procaterol|"Procaterol(Meptin Air) MDI, 20 ug or 2 puffs every 20 minutes
~+ Hydrocortisone, 100 mg IV shall be given immediately at start of treatment"
16239302|NCT01091337|Drug|Salbutamol|Salbutamol(Ventolin Inhaler) MDI, 40 ug or 4 puffs every 20 minutes + Hydrocortisone, 100 mg IV shall be given immediately at start of treatment
16239303|NCT01091324|Drug|Dextromethorphan|60 mg, bid
16239304|NCT01091324|Drug|Silymarin|150 mg , tid
16239305|NCT01091324|Drug|sugar pill|placebo
16239306|NCT01091311|Device|Blephasteam|Eye lid warming goggles
16239307|NCT01091298|Biological|Live Attenuated Tetravalent (G1-G4) Bovine-Human Reassortant Rotavirus Vaccine (BRV-TV)|Single dose (0.5 mL) of the vaccine administered orally
16239308|NCT01091298|Other|Placebo|Single dose (0.5 mL) of the placebo administered orally
16239309|NCT01091285|Device|Foley Catheter|Foley Catheter 16-19 H
16239310|NCT01091285|Device|Double Balloon Catheter|Double Balloon Catheter for 16-19H
16239311|NCT01091272|Drug|PF-04995274|Planned single PO 0.15mg, 1.5mg, 15mg doses of PF-04995274 interleaved with cohort 2 such that doses escalate from 0.15 mg to 50 mg.
16239312|NCT01091272|Drug|PF-04995274|Planned single PO 0.5mg, 5mg, 50mg doses of PF-04995274, interleaved with cohort 2 such that doses escalate from 0.15 mg to 50 mg interleaved with cohort 2 such that doses escalate from 0.15 mg to 50 mg.
16239313|NCT01091272|Drug|PF-04995274|Planned single PO 120mg and 210mg doses of PF-04995274
16239314|NCT01091272|Drug|PF-04995274|single PO dose of PF-04995274; dosage to be determined by safety and pharmacokinetic data
16239315|NCT01091259|Drug|Irinotecan|
16239316|NCT01091259|Drug|Bevacizumab|
16239317|NCT01091246|Biological|Q/LAIV (MEDI3250)|10 ^7.0 ± 0.5 FFU/dose of each of 4 influenza virus strains: A/H1N1, A/H3N2, B/Yamagata, and B/Victoria
16239318|NCT01091246|Biological|FluMist/B/Yamagata|10 ^7.0 ± 0.5 FFU/dose of each of 3 influenza virus strains: A/H1N1, A/H3N2, and B/Yamagata
16239319|NCT01091246|Biological|FluMist/B/Victoria|10 ^7.0 ± 0.5 FFU/dose of each of 3 influenza virus strains: A/H1N1, A/H3N2, and B/Victoria
16239320|NCT01091233|Procedure|paracentesis|as indicated according to the treating physician (the indication for Paracentesis is not the subject of study)
16239321|NCT01091220|Biological|Certolizumab pegol|400 mg certolizumab pegol in 2 x 200 mg/mL, prefilled syringes, administered once, subcutaneously
16239322|NCT01091220|Biological|Placebo|2 x prefilled syringes containing 0.9% saline, administered once, subcutaneously
16239323|NCT01091207|Drug|Sorafenib|The patients will receive daily oral administration of sorafenib 400 mg twice daily.
16239324|NCT01091194|Other|Interval-based aerobic exercise|High intensity interval-based aerobic exercise training. Duration: 1 year. Three 8-weeks supervised periods of physical training 3 times per week. Individual training 2 times per week between these periods.
16239325|NCT01091181|Procedure|hysterotomy at cesarean|incision to open the uterus at cesarean.
16239326|NCT01091168|Drug|vinflunine|280 mg/m2 on day 1 of each cycle every 3 weeks
16239327|NCT01091168|Drug|Alkylating agent of physician choice registered in cancer|cyclophosphamide or melphalan or mitomycin C or thiotepa or cisplatin or carboplatin
16239328|NCT01091155|Device|ColonRing (Colorectal anastomosis)|Creation of a colorectal compression anastomosis
16239329|NCT01091142|Drug|NP001|Cohort 1: 0.3 mg/kg NP001(6:2 active:placebo) Cohort 2: 1.1 mg/kg NP001(6:2 active:placebo) Cohort 3: 2.1 mg/kg NP001(6:2 active:placebo) Cohort 4: 4.3 mg/kg NP001(6:2 active:placebo)
16239330|NCT01091142|Drug|Placebo|Cohort 1: placebo Cohort 2: placebo Cohort 3: placebo Cohort 4: placebo
16239331|NCT01091129|Device|miraDry System (treatment with energy)|Treatment with microwave energy delivery device as specified by manufacturer's instructions
16239332|NCT01091116|Drug|MEN16132 - 0.125 mg|Intra-articular administration of two low doses of MEN16132 at 2-week interval.
16239333|NCT01091116|Drug|MEN16132 - 0.25 mg|Intra-articular injection of two intermediate doses of MEN16132 at 2-week interval
16239334|NCT01091116|Drug|MEN16132 - 0.5 mg|Intra-articular injection of two high doses of MEN16132 at 2-week interval
16239335|NCT01091116|Drug|MEN16132 - 0.5 mg|Single intra-articular injection of one high dose of MEN16132, followed by one dose of placebo at 2-week interval
16239336|NCT01091116|Drug|Placebo|Intra-articular injection of 2 doses of Placebo control at 2-week interval
16239337|NCT01091103|Drug|Enzalutamide|
16239338|NCT01091090|Behavioral|Cognitive behavioral|Cognitive behavioral intervention for smoking cessation
16239339|NCT01091090|Behavioral|Control|Treatment as usual
16239340|NCT01091077|Dietary Supplement|Naringenin|1 gram of naringenin mixed with 16 grams of hydroxypropyl-β-cyclodextrin in 250 mL of water
16239417|NCT01090453|Biological|GSK2202083A vaccine|3 doses given at 2, 4 and 12 months of age
16239341|NCT01091064|Other|Randomization early depart|Patients will be randomized to either an early depart or for being seen by a physician.
16239342|NCT01091051|Drug|Ustekinumab|Patients randomized to ustekinumab (10 with PPPP and 10 with PPP) will receive ustekinumab at Day 0, Weeks 4 and 16 and placebo at Week 20
16239343|NCT01091051|Drug|Placebo (Soduim Chloride)|Patients randomized to placebo (10 with PPPP and 10 with PPP) will receive placebo at Weeks 0 and 4 and ustekinumab at Weeks 16 and 20
16239344|NCT01091038|Other|Basic Clinical Decision Support|The computerized physician order entry (CPOE) intervention provides physicians with a menu of medications from the formulary, default doses, and a range of potential doses for each medication. Physicians were required to enter dosage, route, and frequency for all orders. Also, CPOE ensured that all orders were legible and included the prescribing physician's signature. For a number of medications, the system displayed relevant laboratory results on the screen at the time of ordering. Other features included consequent orders, which are orders that should follow from other orders, and drug-allergy checking, drug-drug interaction checking, and drug-laboratory checking. This included checking for the most frequent drug allergies, about 80 carefully selected drug-drug interactions, and several drug-laboratory combinations
16239345|NCT01091038|Other|Routine Care|Routine Care
16239346|NCT01091025|Other|Glucose profile for 2 weeks|A study subject has an abnormal OGTT will be referred to a cystic fibrosis consultant who is not involved in the study.
16239347|NCT01091012|Drug|Sildenafil 20mg oral vs Sildenafil 10mg intravenous|2 arms to comparation: Sildenafil 20mg oral vs intravenous Sildenafil 10mg
16239348|NCT01090999|Other|long-term maintenance respiratory rehabilitation program|To determine whether a long-term maintenance program after respiratory rehabilitation (group active comparator), in contrast to the usual minimal maintenance therapy (group no intervention), improves the cost-effectiveness through: a.- maintaining long term effects in terms of effort capacity, HRQL, and reduced exacerbations b.- reducing the total cost of care to patients, largely through reduction of exacerbations.
16239349|NCT01090973|Drug|LBH589|"The LBH589 capsule(s) should be swallowed by mouth with a glass of water (8 ounces noncarbonated) in the morning. The daily dose of LBH589 should be taken at approximately the same time each day. Patients should avoid eating grapefruit, Seville (sour) orange or drinking grapefruit juice or Seville orange juice during the study.
~After 2 cycles of treatment, if patients do not demonstrate a partial response or complete response (all of the tumor is gone) to the therapy they will be removed from the study. If patients do obtain a partial (the tumor(s) have decreased in size or number but there are still tumors present) or complete response then treatment will continue until their disease progresses."
16239350|NCT01090960|Drug|GDC-0068|Oral repeating dose
16239351|NCT01090947|Device|ProtoCAD|Aquiring acoustic signals from heart patients.
16239352|NCT01090934|Device|High Resolution EEG|High Resolution EEG
16239353|NCT01090934|Device|Stereo-electroencephalography|SEEG
16239354|NCT01090921|Drug|Bortezomib|"Bortezomib will be administered at a dose of 1.6 mg/m2 IV push. Treatment will be administered once a week for four weeks followed by one week off. This 5 week period is considered a treatment cycle.
~Dexamethasone will also be administered at a dose of 40mg on the day of and day after each dose of bortezomib, with a dose reduction to 20mg on the same schedule if the patient cannot tolerate the higher dose of dexamethasone."
16239355|NCT01090908|Drug|Antibiotic|
16239356|NCT01090895|Drug|Vitamin C|Intravenous infusion of vitamin C (1 g) 10 minutes before percutaneous coronary intervention.
16239357|NCT01090895|Drug|Placebo|Intravenous infusion of placebo(saline solution) 10 minutes before percutaneous coronary intervention.
16239358|NCT01090882|Drug|Bupivocaine|20ml 0.25% at beginning of operation
16239359|NCT01090882|Drug|0.9% normal saline solution|20ml 0.9% NaCl
16239360|NCT01090869|Behavioral|12 weeks of lifestyle change|Participants were randomly assigned to a 12-week intervention in one of four groups: Training (T), energy-reduced Diet (D), Training and increased- Diet (T-iD) or Control (C). The interventions consisted of: T: increased physical activity through daily endurance training equivalent to 600 kcal/day, unchanged diet; D: sedentary lifestyle, reduced diet by 600 kcal/day primarily through reducing serving sizes and substituting energy dense with less energy dense nutrients; T-iD: increased physical activity through daily endurance training equivalent to 600 kcal/day, increased diet by 600 kcal/day primarily through increasing serving sizes and consuming energy dense nutrients; C: sedentary lifestyle and unchanged diet.
16239361|NCT01090856|Procedure|Pre-dilation side branch|Balloon pre-dilation of the side branch to facilitate the ulterior wire access.
16239362|NCT01090843|Procedure|Video capsule endoscopy (VCE)|In the context of video capsule endoscopy the patient will swallow the first capsule after successful mounting of adhesive electrodes and registering tool of both capsule products. The second capsule will be swallowed two hours later. The two capsules used in our investigation are the MiroCam® (product of IntroMedic®, Seoul, Korea) and the Enteropro EndoCapsule® (product of Olympus®, Tokyo, Japan). To reduce bias made up by the sequence of the capsules used, we will randomize the capsule positions at each examination, following a computer generated list.
16239363|NCT01090843|Device|MiroCam|In the context of video capsule endoscopy the patient will swallow the first capsule after successful mounting of adhesive electrodes and registering tool of both capsule products. The second capsule will be swallowed two hours later. The two capsules used in our investigation are the MiroCam® (product of IntroMedic®, Seoul, Korea) and the Enteropro EndoCapsule® (product of Olympus®, Tokyo, Japan). To reduce bias made up by the sequence of the capsules used, we will randomize the capsule positions at each examination, following a computer generated list.
16239364|NCT01090843|Device|Enteropro EndoCapsule|In the context of video capsule endoscopy the patient will swallow the first capsule after successful mounting of adhesive electrodes and registering tool of both capsule products. The second capsule will be swallowed two hours later. The two capsules used in our investigation are the MiroCam® (product of IntroMedic®, Seoul, Korea) and the Enteropro EndoCapsule® (product of Olympus®, Tokyo, Japan). To reduce bias made up by the sequence of the capsules used, we will randomize the capsule positions at each examination, following a computer generated list.
16239411|NCT01090492|Drug|PF-00489791|Subjects with Primary Raynaud's Phenomenon will receive placebo once a day for the first 4 week cross over period and then PF-00489791 20 mg once a day for the second 4 week cross over period
16239412|NCT01090479|Drug|2% Chlorhexidine cloth|The 2% Chlorhexidine cloth will be applied to the operative extremity the night prior and the the morning of their surgery.
16239413|NCT01090466|Drug|cisplatin|
16239365|NCT01090830|Drug|Belinostat, carboplatin, paclitaxel and bevacizumab|"Induction therapy will include 6 cycles of 5-days of medication administration followed by a 16 day rest period. Belinostat will be given once a day for 5 days total. Three dose levels will be evaluated (600mg/kg, 800 mg/kg, and 1000 mg/kg). In addition, participants will receive fixed doses of intravenous carboplatin (AUC 6), Paclitaxel (200 mg/m2), and bevacizumab (15 mg/kg) once on day 3 of each cycle. Serial disease status evaluations will be done throughout the study.
~In the absence of significant toxicity or disease progression, participants may continue with a maintenance regimen of bevacizumab and Belinostat for an additional 6 cycles. The dose of Belinostat received during maintenance will be that tolerated in the initial 6 cycles."
16239366|NCT01090817|Drug|Mesenchymal stromal cells (MSC) for infusion|MSC 2X10E6/kg recipient weight are infused over 15 minutes intravenously weekly for 4 weeks
16239367|NCT01090804|Device|BreatheMAX breathing device|secretion clearance, breathing exercise
16239368|NCT01090791|Device|Flotrac/Vigileo third generation software|Measurement of stroke volume according to the arterial pressure waveform
16239369|NCT01090791|Device|Transthoracic echocardiography|Measurement of stroke volume according to the aortic time-velocity integral
16239370|NCT01090778|Drug|Norditropin SimpleXx (growth hormone)|3mg/subject/day over two consecutive days
16239371|NCT01090765|Drug|TRC105|
16239372|NCT01090752|Drug|Pioglitazone|placebo-controlled, randomized, cross-over study was to explore the effects of pioglitazone (45 mg q.d. for 6 weeks) on the renal, hormonal and blood pressure responses to changes in sodium intake in a population prone to insulin resistance
16239373|NCT01090752|Drug|Metformin|placebo-controlled, randomized, cross-over study was to explore the effects of pioglitazone (45 mg q.d. for 6 weeks) on the renal, hormonal and blood pressure responses to changes in sodium intake in a population prone to insulin resistance
16239374|NCT01090739|Device|TOPAS Treatment for Fecal Incontinence|The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
16239375|NCT01090726|Device|Storz videolaryngoscope|Storz videolaryngoscope being used for the actual intubation
16239376|NCT01090726|Device|Airtraq|Airtraq being used for the actual intubation
16239377|NCT01090713|Drug|lisdexamfetamine|oral; 20-70mg/day
16239378|NCT01090713|Drug|Placebo control|20-70mg; oral
16239379|NCT01090700|Drug|TMC435|TMC435 150 mg daily for 7 days
16239380|NCT01090700|Drug|Escitalopram|Escitalopram 10 mg daily for 7 days
16239381|NCT01090700|Drug|TMC435 + Escitalopram|TMC435 150 mg + escitalopram 10 mg daily for 7 days
16239382|NCT01090687|Radiation|computed tomography (CT scan)|Subjects will undergo cone beam breast CT scan
16239383|NCT01090687|Device|computed tomography (CT scan)|Subjects will undergo cone beam breast CT scan
16239384|NCT01090674|Other|No intervention|We perform in all patients respiratory functional tests, thoracic x-ray, SNIF test and diaphragmatic magnetic resonance imaging.
16239385|NCT01090661|Drug|mipomersen sodium|200 mg of mipomersen intravenous (IV) (single dose)
16239386|NCT01090661|Drug|mipomersen sodium|200 mg of mipomersen subcutaneous (SC) (single dose)
16239387|NCT01090661|Drug|moxifloxacin hydrochloride (Avelox®)|400 mg of moxifloxacin intravenous (IV) single dose
16239388|NCT01090661|Drug|placebo|placebo intravenous (IV) single dose
16239389|NCT01090661|Drug|placebo|placebo subcutaneous (SC) single dose
16239390|NCT01090648|Drug|etravirine|One etravirine (ETR) 200 mg uncoated oral tablet and one etravirine (ETR) 200 mg film-coated tablet
16239391|NCT01090622|Drug|XPF-001|Oral capsule
16239392|NCT01090622|Drug|Placebo|Oral capsule
16239393|NCT01090609|Device|Stent implantation|Stent implantation
16239394|NCT01090596|Drug|Naproxen|500mg naproxen, twice daily for 7 days
16239395|NCT01090596|Drug|Placebo|1 tab,twice a day for a seven days
16239396|NCT01090583|Other|Specimen Collection|We will compare mediators from non-invasive samples (blood, urine, saliva, vaginal or cervical secretions) with traditional gold-standard invasive samples (amniotic fluid and placenta samples).
16239397|NCT01090570|Drug|PLX3397|Once-daily oral capsules
16239398|NCT01090557|Other|Collection of exhaled breath|balloon collection, via the tidal breathing techniques with uncontrolled flow rate for offline feNO measurement
16239399|NCT01090544|Device|Nasal Insufflation|Breathing therapy
16239400|NCT01090518|Behavioral|Prolonged Exposure therapy|10 weekly sessions
16239401|NCT01090518|Drug|Hydrocortisone|30mg 20 minutes prior to each PE session including imaginal exposure (8 total)
16239402|NCT01090518|Behavioral|Prolonged Exposure therapy|10 weekly sessions
16239403|NCT01090505|Drug|Drug: S-1 and oxaliplatin|Drug:S-1:80mg/m2;oxaliplatin 130mg/m2
16239404|NCT01090492|Drug|PF-00489791|Subjects with Secondary Raynaud's Phenomenon will receive PF-00489791 4 mg once a day for the first 4 week cross over period and then placebo once a day for the second 4 week cross over period
16239405|NCT01090492|Drug|PF-00489791|Subjects with Secondary Raynaud's Phenomenon will receive placebo once a day for the first 4 week cross over period and then PF-00489791 4 mg once a day for the second 4 week cross over period
16239406|NCT01090492|Drug|PF-00489791|Subjects with Secondary Raynaud's Phenomenon will receive PF-00489791 20 mg once a day for the first 4 week cross over period and then placebo once a day for the second 4 week cross over period
16239407|NCT01090492|Drug|PF-00489791|Subjects with Secondary Raynaud's Phenomenon will receive placebo once a day for the first 4 week cross over period and then PF-00489791 20 mg once a day for the second 4 week cross over period
16239408|NCT01090492|Drug|PF-00489791|Subjects with Primary Raynaud's Phenomenon will receive PF-00489791 4 mg once a day for the first 4 week cross over period and then placebo once a day for the second 4 week cross over period
16239409|NCT01090492|Drug|PF-00489791|Subjects with Primary Raynaud's Phenomenon will receive placebo once a day for the first 4 week cross over period and then PF-00489791 4 mg once a day for the second 4 week cross over period
16239410|NCT01090492|Drug|PF-00489791|Subjects with Primary Raynaud's Phenomenon will receive PF-00489791 20 mg once a day for the first 4 week cross over period and then placebo once a day for the second 4 week cross over period
16239414|NCT01090466|Drug|gemcitabine hydrochloride|
16239415|NCT01090466|Drug|temsirolimus|
16239419|NCT01090453|Biological|Infanrix hexa™|3 doses given at 2, 4 and 12 months of age
16239420|NCT01090453|Biological|Menjugate®|3 co-administered doses
16239421|NCT01090453|Biological|Rotarix™|Oral, two doses
16239422|NCT01090440|Drug|GSK1144814|This study is an open label, randomised, three-way cross-over study to evaluate the pharmacokinetics, effect of food, safety and tolerability of a new tablet formulation of GSK1144814 in healthy male and female (non-child bearing potential) subjects. Sixteen subjects will be enrolled to provide a minimum number of 12 evaluable subjects. The doses to be administered will be 100 mg and 200mg in the fasted state, and 100mg following a high fat breakfast.
16239423|NCT01090427|Drug|Ustekinumab - Half-Standard Dosage|Ustekinumab 0.375 mg/kg, 22.5 mg, or 45 mg based on body weight, administered subcutaneously (under the skin) at Weeks 0, 4, 16, 28, and 40.
16239424|NCT01090427|Drug|Ustekinumab - Standard Dosage|Ustekinumab 0.75 mg/kg, 45 mg, or 90 mg based on body weight administered subcutaneously at Weeks 0, 4, 16, 28, and 40.
16239425|NCT01090427|Other|Placebo|Placebo administered subcutaneously at Weeks 0 and 4 or at Week 12.
16239426|NCT01090414|Drug|Idelalisib|Idelalisib tablets or capsules administered orally
16239427|NCT01090401|Device|Linox smart S DX|ICD lead
16239428|NCT01090375|Other|Exercise|
16239429|NCT01090375|Other|Non Exercise|
16239430|NCT01090349|Device|Implantation of an ICD/CRT-D device|The Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy (CRT-D) device and leads are not the devices being evaluated in this investigation.
16239431|NCT01090349|Device|Merlin.NET PCN|The Merlin.Net™ PCN is a dedicated computer system that connects physicians to patients outside of the clinic setting by centralizing data from remote transmissions, implant procedures and in-clinic follow-ups into single location with easy export to Electronic Health Record (EHR) systems
16239432|NCT01090323|Drug|ICL670|Daily doses of ICL670 were taken orally 30 minutes before breakfast. The doses range from 5-40 mg/kg and were determined based on the patient's trend in serum ferritin over time during the core study (0109) and on the frequency of blood transfusions the patient received. The treatment duration was up to 4 years.
16239433|NCT01090310|Drug|AIN457|AIN457 150 mg powder for solution was provided in glass vials each containing 150 mg AIN457 as a lyophilized cake
16239434|NCT01090310|Drug|Placebo|Matching placebo to AIN457
16239435|NCT01090297|Device|S8 Spirit 2|"3 types of Continuous Positive Airway Pressure (CPAP) device: S8 Spirit 2, Somnosmart 2, Remstar Auto.
~These 3 types of CPAP can be set in both mode of pressure."
16239436|NCT01090297|Device|Somnosmart 2|"3 types of Continuous Positive Airway Pressure (CPAP) device: S8 Spirit 2, Somnosmart 2, Remstar Auto.
~These 3 types of CPAP can be set in both mode of pressure."
16239437|NCT01090297|Device|Remstar Auto|"3 types of Continuous Positive Airway Pressure (CPAP) device: S8 Spirit 2, Somnosmart 2, Remstar Auto.
~These 3 types of CPAP can be set in both mode of pressure."
16239438|NCT01090284|Device|Inguinal hernioplasty|A conventional Prosthetic Inguinal Hernioplasty (Trabucco's Technique) will be performed by using polypropylene mesh.
16239439|NCT01090271|Device|Isokinetic eccentric training|The eccentric training for the shoulder abductors was performed for 6 consecutive weeks, twice a week, on alternate days.
16239440|NCT01090258|Device|Hamilton ventilator (G5 modify to S1) Automated settings|Automated settings (respiratory rate [RR], FiO2, Insp and exp pressures) Ventilator settings automatically adjusted by the evaluated system, concerning the FiO2, the respiratory rate, the inspiratory and expiratory pressures and related settings (triggers, pressurization ramp, inspiratory/expiratory time...)
16239441|NCT01090258|Other|Hamilton ventilator (G5) protocolized settings|Mechanical ventilation settings performed by the respiratory therapists according to the local protocols
16239442|NCT01090245|Behavioral|Contingency management: voucher/monetary incentives for treatment attendance|Contingency management: Escalation with reset for non-attendance. Daily. Up to $841.50 in incentives for treatment attendance.
16239443|NCT01090245|Behavioral|Information|Attendance Information Group will receive an individual information session along with a pamphlet describing the benefits of remaining in treatment after release from prison and on the benefits of HIV prevention and testing.
16239444|NCT01090232|Other|blood samples|
16239445|NCT01090232|Other|blood samples|
16239446|NCT01090219|Procedure|two different meshes in the repair of inguinal hernias|A Lichtenstein tension-free hernia repair was accomplished by emplacing Heavy-weight versus low-weight polypropylene meshes for repair of incisional hernia, marked next to the lips with six titanium clips (LT200)
16239447|NCT01090206|Dietary Supplement|Vitamin D and calcium|Doses will be based on Vitamin D levels
16239448|NCT01090193|Procedure|Whipple operation,Hepaticojejunostomy|Whipple operation, Hepaticojejunostomy
16239449|NCT01090180|Drug|Dexamethasone|anti-inflammatory adrenocortical steroid The following dose schedule will be given: 0.15mg/kg (based on body weight) every 7 days for 4 consecutive weeks
16239450|NCT01090180|Drug|Placebo (sugar pill)|inactive
16239451|NCT01090167|Drug|clofarabine|Intravenous, 20 mg/m2, 30 mg/m2, 40 mg/m2
16239452|NCT01090154|Drug|Cimzia|Cimzia 400mg administered via two 200mg subcutaneous injections at weeks 0, 2, and 4; followed by every 4 week dosing.
16239453|NCT01090141|Drug|Micafungin|100 mg IV infusion over 1 hour
16239454|NCT01090141|Drug|Micafungin|300 mg IV infusion over 1 hour
16239455|NCT01090128|Drug|Nanoparticle Albumin Bound Paclitaxel|IV administered over 30 minutes. 100 mg/m2 on days 1 and 8
16239456|NCT01090128|Drug|doxorubicin|50 mg/m2 every 3 weeks
16239457|NCT01090128|Drug|cyclophosphamide|500 mg/m2 given every 3 weeks
16239458|NCT01090102|Drug|Mesalamine (5-aminosalicylic acid, Apriso)|"Four mesalamine capsules once daily (1.5 gram/day) for the first 12 weeks, PO(by mouth).
~Four placebo capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth)."
16239459|NCT01090102|Drug|Placebo|"Four placebo capsules once daily (1.5g/d) for the first 12 weeks, PO (by mouth).
~Four mesalamine capsules once daily (1.5g/d) for another 12 weeks, PO (by mouth)."
16239460|NCT01090089|Drug|Lenalidomide, Dexamethasone|Rd until progression or max. 5 years (Rd = lenalidomide 25 mg d1-21/28d + dexamethasone 40 mg po d1, d8, d15, d22/28d)
16239461|NCT01090089|Drug|Lenalidomide, Dexamethasone, PBSCT|Induction with 3 cycles Rd, tandem high dose melphalan (140 mg/m²) with autologous peripheral blood stem cell transplantation (PBSCT) followed by lenalidomide maintenance (10 mg/day) until progression or max. 5 years
16239462|NCT01090076|Dietary Supplement|Abound (7 g of Arginine, 7 g Glutamine and 1.2 g HMB)|Active Arm : Abound x 2 sachets/d (Each sachet provides additional 7g L-Arginine, 7g L-Glutamine, 1.2 g HMB and 79 Kcal) Placebo Arm: Abound(placebo) x 2 sachets/d
16239463|NCT01090063|Drug|Ustekinumab|Dosing will consist of a 45mg subcutaneous injection for patients weighing less than 100 kg and a 90 mg subcutaneous injection for patients whose weight is greater than 100 kg. Dosing will begin on week 0 followed by subsequent dosing on week 4 and week 16.
16239464|NCT01090050|Drug|Sumatriptan/Naproxen Sodium|Each tablet of Sumatriptan/Naproxen Sodium for oral administration contains sumatriptan 85mg / naproxen sodium 500mg. Study medication is to be administered 1 tablet per day x 30 days in Treatment Period Month 1. Study medication may be administered on up to 14 days per month in Treatment Period Months 2 and 3.
16239465|NCT01090050|Drug|Naproxen Sodium|Each tablet of Naproxen Sodium for oral administration is provided in 500mg tablet. Study medication is to be administered 1 tablet per day x 30 days in Treatment Period Month 1. Study medication may be administered on up to 14 days per month in Treatment Period Months 2 and 3.
16239466|NCT01090037|Drug|TRK-100STP high dose|
16239467|NCT01090037|Drug|TRK-100STP low dose|
16239468|NCT01090037|Drug|Placebo|
16239469|NCT01090024|Drug|BI 671800|Double blind randomised cross-over study to assess efficacy, safety and tolerability
16239470|NCT01090024|Drug|BI 671800|Double blind randomised cross-over study to assess efficacy, safety and tolerability
16239471|NCT01090024|Drug|BI 671800|Double blind randomised cross-over study to assess efficacy, safety and tolerability
16239472|NCT01090024|Drug|Placebo|Patients receive placebo capsules
16239473|NCT01090011|Drug|Cetuximab|BIBW 2992 medium dose plus high dose level of cetuximab
16239474|NCT01090011|Drug|Cetuximab|BIBW 2992 medium dose monotherapy, upon progression, cetuximab high dose is added
16239475|NCT01090011|Drug|BIBW 2992|BIBW 2992 medium dose plus high dose level of cetuximab
16239476|NCT01090011|Drug|BIBW 2992|BIBW 2992 medium dose monotherapy, upon progression, cetuximab high dose is added
16239477|NCT01089998|Drug|BAY86-9596|Healthy volunteers, single intravenous bolus injection of 200 MBq BAY 86-9596 on day one of the treatment period, whole body PET/CT for determination of effective dose, kinetics of BAY 86-9596 in blood and urine
16239478|NCT01089998|Drug|BAY86-9596|Cancer patients, single intravenous bolus injection of 300 MBq BAY 86-9596 on day one of the treatment period, PET/CT.
16239479|NCT01089998|Drug|BAY86-9596|Inflammation patients, single intravenous bolus injection of 300 MBq BAY 86-9596 on day one of the treatment period, PET/CT.
16239480|NCT01089998|Drug|Fludeoxyglucose (18F)-IBA|Subgroup of cancer patients: radiation induced inflammation. Fluordeoxyglucose (18F)-FDG PET scan will be performed approx. 4 week after radiation and compared with tracer BAY86-9596 (acc. to Amendment 4 only in the Netherlands)
16239481|NCT01089985|Drug|Autologous serum eyedrops|3 times a day for the duration of the study
16239482|NCT01089972|Device|22 gauge catheter|radial artery cannulation using 22 gauge catheter
16239483|NCT01089972|Device|20 gauge catheter|radial artery cannulation using 20 gauge catheter
16239484|NCT01089959|Drug|Esomeprazole|40 mg daily for 7 days
16239485|NCT01089959|Drug|esomeprazole|40 mg. daily, oral medication, once daily for 7 days.
16239486|NCT01089933|Procedure|Thoracic Paravertebral Block (TPVB)|The middle of the spinous process above the nerve to be blocked is located and the overlying skin marked 2.5 centimeters lateral to this. Subcutaneous lidocaine is injected and a 22 G Tuohy tipped 8 cm needle is inserted at this level and advanced to identify the transverse process. The needle is then moved caudad off the transverse process and inserted a centimeter into the paravertebral space. Five mls of 0.5% ropivacaine with 1:200,000 epinephrine is injected at each paravertebral space. Blocks adjacent to the C7-T5 spinous processes are performed. For patients randomized to the LA group: The patients are identically positioned, sedated and identical landmarks are used to perform sham paravertebral blocks via a subcutaneous saline injection of 0.5mL with a 25G needle at each level.
16239487|NCT01089933|Procedure|Local Anesthetic|At the conclusion of surgery, the surgeon will infiltrate the incision with 10 ml of saline 0.9% (TPVB group) or 0.5% ropivacaine (LA group). An axillary drain will be placed. After closure of the wound, 20 ml of saline 0.9% (TPVB group) or 0.5% ropivacaine (LA group) will be injected through the drain and the drain clamped for 30 minutes after injection.
16239488|NCT01089920|Other|Green tea|Infusion (tea bags) from commercially available green tea
16239489|NCT01089920|Other|Coffee|Soluble coffee commercially available
16239490|NCT01089855|Drug|Carbamazepine|
16239491|NCT01089842|Behavioral|Health coaching|Coaching based advice will be performed by previously trained nurses. Intervention will be directed to increase physical activity to achieve levels recommended on guidelines. Patients will receive one session per month during 6 months. Time for each session is estimated on 10 to 20 minutes. Sessions will be mostly carried out by phone, although physical attendance or internet services can also be used.
16239492|NCT01089842|Other|Usual care|Patients on control group will receive usual assistance, including physical activity counselling by their treating physician.
16239493|NCT01089829|Other|Foot examination|"Non-invasive neurological sensory testing
~Non-invasive doppler assessment of peripheral arterial system"
16239494|NCT01089816|Biological|Local/Regional Public Health Notification|For any H5 positive results, notification of the result to the site's local/regional public health authorities.
16239495|NCT01089790|Drug|Dutogliptin|400 mg tablet, once daily
16239496|NCT01089790|Drug|Sitagliptin|100 mg capsule (each capsule contains two 50-mg tablets), once daily
16239497|NCT01089777|Device|ultrasound Doppler monitoring|Ultrasound Doppler monitoring throughout the stress test
16239498|NCT01089764|Behavioral|Couplelinks.ca website|Participation in the Couplelinks.ca program, an online intervention.
16239499|NCT01089751|Drug|trospium chloride|Sanctura XR® (trospium chloride) 60 mg once daily on an empty stomach for 14 weeks
16239500|NCT01089751|Drug|placebo|Placebo once daily on an empty stomach for 14 weeks.
16239501|NCT01089738|Drug|PF-03382792 0.5mg|0.5 mg PF-03382792, qd, for 14 days or placebo
16239502|NCT01089738|Drug|PF-03382792 1.5 mg|1.5 mg PF-03382792, qd, for 14 days or placebo
16239503|NCT01089738|Drug|PF-03382792 5 mg|5 mg PF-03382792, qd, for 14 days or placebo
16239504|NCT01089738|Drug|PF-03382792 15 mg|15 mg PF-03382792, qd, for 14 days or placebo
16239505|NCT01089725|Biological|Placebo IV|1 ml of placebo administered SC and IV once every 8 weeks.
16239506|NCT01089725|Biological|Placebo SC|1 ml of placebo administered SC and IV once every 8 weeks.
16239507|NCT01089725|Biological|Tanezumab SC|1 ml tanezumab injection SC administered every 8 weeks
16239508|NCT01089725|Biological|Placebo IV|1 ml placebo administered IV every 8 weeks
16239509|NCT01089725|Biological|Tanezumab SC|1 ml tanezumab injection SC administered every 8 weeks
16239510|NCT01089725|Biological|Placebo IV|1ml placebo administered IV every 8 weeks
16239511|NCT01089725|Biological|Tanezumab SC|1 ml tanezumab injection SC administered every 8 weeks
16239512|NCT01089725|Biological|Placebo IV|1ml placebo administered IV every 8 weeks
16239513|NCT01089725|Biological|Tanezumab IV|1 ml tanezumab injection IV administered every 8 weeks
16239514|NCT01089725|Biological|Placebo SC|1ml placebo administered SC every 8 weeks
16239515|NCT01089699|Behavioral|online support group|online support group
16239516|NCT01089699|Behavioral|online support group|online support group
16239517|NCT01089699|Behavioral|home study support materials|self-study materials
16239518|NCT01089686|Procedure|Venoplasty|Venous access is obtained from the groin through the femoral vein. The catheter will be advanced into the veins in the neck and chest. Angiographic images will be taken of the extracranial venous system as well as the azygous vein. These images will be used to confirm CCSVI. Venoplasty is performed by inserting an additional catheter with a balloon at the tip. The balloon will be inflated to open the vessel. Once dilation of the vessel is confirmed, the venous sheath will be removed and manual compression applied to the groin access.
16239519|NCT01089686|Procedure|Sham procedure (non-treatment)|Venous access is obtained from the groin through the femoral vein. The catheter will be advanced into the veins in the neck and chest. Angiographic images will be taken of the extracranial venous system as well as the azygous vein. These images will be used to confirm CCSVI. Since the patient has been randomized to the non-treatment arm of the trial, the procedure will end without venoplasty. After completion of the diagnostic venogram, the venous sheath will be removed and manual compression applied to the groin access.
16239520|NCT01089673|Other|data collection|retrospective data collection
16239521|NCT01089660|Biological|Swine A/H1N1 influenza vaccine (split virion, inactivated)|0.3 mL, Intramuscular (IM)
16239522|NCT01089660|Biological|Swine A/H1N1 influenza vaccine (split virion, inactivated)|0.5 mL, Intramuscular (IM)
16239523|NCT01089647|Drug|budesonide and montelukast|budesonide aqua nasal spray 1 spray each nostril bid for 12 weeks Montelukast pill 10 mg po daily for 12 weeks
16239524|NCT01089647|Drug|Placebo|sugar pill po daily for 12 weeks salt water nasal spray 1 spray each nostril bid for 12 weeks
16239525|NCT01089621|Drug|Duloxetine|30 mg to 120 mg administered orally, daily for 12 weeks
16239526|NCT01089608|Drug|Azithromycin|"Eye drops, Dosage : 1.5%
~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
16239527|NCT01089608|Drug|Povidone|"Eye drops Single dose unit
~1 drop twice daily at Day 0, then 1 drop once daily from Day 1 to Day 6 in the morning, following by a period of 2 weeks without treatment. This therapeutic scheme will be repeat 2 times."
16239528|NCT01089595|Drug|Nilotinib|Nilotinib 400 mg po bid
16239529|NCT01089595|Drug|Nilotinib with Imatinib|Nilotinib 400 mg po BID Imatinib 400 mg po daily
16239530|NCT01089582|Other|No intervention|
16239531|NCT01089569|Drug|Exenatide|5 mcg BID (twice daily) for 1 month increasing to 10 mcg BID for the remainder of the study
16239532|NCT01089569|Drug|Insulin Glargine|.1 unit per kg to start, titrated based on Continuous Glucose Monitoring results
16239533|NCT01089556|Drug|Duloxetine|Administered orally
16239534|NCT01089556|Drug|Pregabalin|Administered orally
16239535|NCT01089556|Drug|Placebo|Administered orally, daily as a blind for duloxetine and/or pregabalin for 8 or 16 weeks
16239536|NCT01089543|Drug|Rabeprazole|Rabeprazole 10 mg tablet taken orally once daily after breakfast for 8 weeks.
16239537|NCT01089543|Drug|Rabeprazole|Rabeprazole 20 mg tablet taken orally once daily after breakfast for 8 weeks.
16239538|NCT01089543|Drug|Rabeprazole|Rabeprazole 40 mg tablet taken orally once daily after breakfast for 8 weeks.
16239539|NCT01089543|Drug|Placebo|Rabeprazole Placebo tablet taken orally once daily after breakfast for 8 weeks.
16239540|NCT01089530|Behavioral|Lifestyle intensive group|hipocaloric diet smoking cessation physical exercise
16239541|NCT01089517|Drug|E10030 plus Lucentis|once a month intravitreal injection
16239542|NCT01089517|Drug|Lucentis|10 mg/mL intravitreal injection monthly
16239543|NCT01089504|Drug|phenobarbital|Phenobarbital, 4-5 mg/kg/d, by mouth, for 4 months
16239544|NCT01089504|Drug|placebo|Matched placebo, same volume as active drug, by mouth daily for 4 months
16239545|NCT01089465|Other|Collection of the bedbugs and dermatological follow-up of the stings|Collection of the bedbugs and dermatological follow-up of the stings at J1 J7 J14 J21 J28
16239546|NCT01089452|Drug|Perindopril|Perindopril 5mg for 4 weeks, forced titration to 10mg for 8 weeks
16239547|NCT01089452|Drug|Perindopril/amlodipine|Perindopril/amlodipine 5/5mg, 10/5mg, 10/10mg: 4 weeks duration at each dose; forced titration.
16239548|NCT01089452|Drug|Olmesartan/amlodipine|Olmesartan/amlodipine 20/5mg, 40/5mg, 40/10mg: 4 weeks at each dose; forced titration.
16239549|NCT01089439|Drug|Nitric oxide by inhalation INOMAX|"Nitric oxide by inhalation INOMAX 800 ppm
~40 ppm during 24 hours then 20 ppm during 24 hours then 10 ppm during 24 hours"
16239550|NCT01089439|Drug|Placebo|placebo
16239551|NCT01089426|Drug|Omegaven™|1 g/kg/d of Omegaven until discontinuation of PN
16239552|NCT01089426|Other|Historical Controls|Standard of Care
16239553|NCT01089413|Drug|bevacizumab [Avastin]|As prescribed by physician
16239554|NCT01089387|Biological|injection of bone marrow mononucleated cells|Four different concentration of BMMNC will be tested in four groups of 3 patients. In group 5 (n=19): one cell concentration corresponding to the best dose determined by analysis of the previous groups will be tested.
16239669|NCT01088399|Drug|Somatropin (rDNA origin)|Dose, frequency and duration are at discretion of attending physician, and determined on an individual basis.
16239672|NCT01088347|Drug|cisplatin|Cisplatin 40 mg/m2 intravenously on days 8, 15, 22, 29, 36, and 45
16239555|NCT01089374|Radiation|Partial breast radiation after lumpectomy|Radiation therapy will be administered in the vicinity of the center where the surgical resection was performed. Adjuvant radiation must start within 12 weeks of breast excision or re-excision. The radiation oncologist can choose between two methods of partial breast irradiation (PBI): external beam partial breast radiation or Mammosite® brachytherapy, based on radiation oncologist and patient preference. Radiation will be administered per guidelines used in the NSABP B-39/RTOG 0413 protocol.
16239556|NCT01089361|Drug|Ketamine|The treatment group will receive 0.25mg/kg of ketamine over a period of one hour followed by a continuous infusion of ketamine at 0.1 mg/kg/hr for a further 23 hours.
16239557|NCT01089361|Drug|Normal Saline placebo|The control group will receive 0.25mg/kg of normal saline over a period of one hour followed by a continuous infusion of normal saline at 0.1 mg/kg/hr for a further 23 hours.
16239558|NCT01089348|Drug|Lactofiltrum + Metronidazole|Metronidazole 500 mg 1 tablet BID for 7 days + Lactofiltrum 2 tablets 3 times per day for 14 days per os
16239559|NCT01089348|Drug|Metronidazole|Metronidazole 500 mg 1 tablet BID for 7 days per os
16239560|NCT01089335|Procedure|Histological investigation of the SN|99m Tc- nanocolloid albumin, 10-15 MBq (volume 0.1-0.3 ml) is injected under ultrasound guidance in the thyroid tumour. Imaging (lymphoscintigraphy)with anterior and oblique projections is performed at 60 and 120 min after the injection. SN are mapped intraoperatively by a dedicated SN navigator and excised for final histology.
16239561|NCT01089322|Drug|inhaled corticosteroid plus LABA plus oral corticosteroid|formoterol plus budesonide 12/400mcg 2times/day and 6/200 mcg as needed and prednisone 40 mcg
16239562|NCT01089309|Drug|Spironolactone|Spironolactone orally, at a dose of 50 mg/day for 12 months
16239563|NCT01089296|Other|Individually customized physiotherapy|Main elements in the intervention are postural support and facilitating techniques. The intervention will be carried out twice a day over a three-week period if the infant's condition allows it. The length of each treatment session will be adjusted dependent on the infant's response and condition. Maximum treatment time is 10 minutes.
16239564|NCT01089231|Dietary Supplement|Fish oil|Dietary Supplement: fish oil capsules (6 per day) 3024 mg n-3 fatty acids daily (1512 mg EPA and 1008 mg DHA) about 3 months
16239565|NCT01089231|Dietary Supplement|Placebo (corn oil)|corn oil (6 capsules per day)
16239566|NCT01089218|Drug|oral amoxicillin/clavulanate 1g (875/125mg)|oral amoxicillin/clavulanate 1g (875/125mg) on the day of the procedure 30 minutes prior to the FB
16239567|NCT01089218|Drug|control|no intervention with the same procedure of FB
16239568|NCT01089205|Drug|Metformin|
16239569|NCT01089192|Drug|Metformin|
16239570|NCT01089179|Drug|Metformin|
16239571|NCT01089166|Drug|Metformin|
16239572|NCT01089140|Drug|Tranexamic acid 10mg/kg/hr|Tranexamic acid is a synthetic antifibrinolytic drug that competitively inhibits the lysine binding sites of plasminogen, plasmin, and tissue plasminogen activator
16239573|NCT01089140|Drug|Tranexamic acid 100 mg/kg/h infusion|Tranexamic acid is a synthetic antifibrinolytic drug that competitively inhibits the lysine binding sites of plasminogen, plasmin, and tissue plasminogen activator.
16239574|NCT01089140|Drug|Saline solution|Saline placebo
16239575|NCT01089127|Drug|Indacaterol|Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
16239576|NCT01089127|Drug|Salmeterol 50 μg|Salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.
16239577|NCT01089127|Drug|Placebo to indacaterol|Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
16239578|NCT01089127|Drug|Placebo to salmeterol|Placebo to salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.
16239582|NCT01089088|Drug|cisplatin|"Up to six 21 day chemotherapy cycles:
~Cisplatin 70mg/m2 (IV day 1) Gemcitabine 1000mg/m2 (IV days 1 & 8) Sunitinib 37.5mg (po days 2 to 15)"
16239583|NCT01089088|Drug|gemcitabine hydrochloride|"Up to six 21 day chemotherapy cycles:
~Cisplatin 70mg/m2 (IV day 1) Gemcitabine 1000mg/m2 (IV days 1 & 8) Sunitinib 37.5mg (po days 2 to 15)"
16239584|NCT01089088|Drug|sunitinib malate|"Up to six 21 day chemotherapy cycles:
~Cisplatin 70mg/m2 (IV day 1) Gemcitabine 1000mg/m2 (IV days 1 & 8) Sunitinib 37.5mg (po days 2 to 15)"
16239585|NCT01089075|Drug|Hydrocortisone|20 mg po for 7 days (2 tablets)
16239586|NCT01089075|Drug|Placebo|2 tablets po
16239587|NCT01089062|Drug|MAP0004|1.0 mg orally inhaled MAP0004 administered in Treatment B as per protocol
16239588|NCT01089062|Drug|IV Placebo (Saline)|IV Placebo (Saline) administered in Treatment B and Treatment C as per protocol
16239589|NCT01089062|Drug|Placebo Inhaler|Orally inhaled Placebo administered in Treatment A and Treatment C as per protocol.
16239590|NCT01089062|Drug|IV Dihydroergotamine Mesylate (DHE)|IV DHE administered in Treatment A as per protocol
16239591|NCT01089049|Dietary Supplement|FemMED Breast Health Formula|Two capsules daily, with meals. FemMED Breast Health Formula containing lignans.
16239592|NCT01089023|Drug|tocilizumab [RoActemra/Actemra]|8 mg/kg iv infusion, every 4 weeks for a total of 6 infusions
16239593|NCT01089010|Drug|Placebo|Matching placebo in capsules administered as a single oral dose.
16239594|NCT01089010|Drug|250 mg CK-2017357|250 mg CK-2017357 in capsules administered as a single oral dose.
16239595|NCT01089010|Drug|500 mg CK-2017357|500 mg CK-2017357 in capsules administered as a single oral dose.
16239596|NCT01088997|Drug|Milrinone Lactate|Milrinone lactate will be given first as an IV bolus over one hour at the assigned dose level, followed by a 24 hour IV infusion at the assigned dose level.
16239597|NCT01088984|Drug|Bendamustine|
16239598|NCT01088971|Dietary Supplement|Duolac7S|1 capsule two times everyday for 6 weeks
16239599|NCT01088971|Dietary Supplement|starch|1capsule two times everyday for 6 weeks
16239670|NCT01088373|Drug|Azacitidine combined to Lenalidomide|Azacitidine: 75mg/m2/d for 5 days per cycle of 28 days. Lenalidomide: 5mg/day during 14 days for cohort 1. Lenalidomide: 5mg/day during 21 days for cohort 2. Lenalidomide: 10mg/day during 21 days for cohort 3.
16239671|NCT01088347|Drug|mapatumumab|Mapatumumab (10 or 30 mg/kg) intravenously on days 1, 22, and 45. In phase 2 the MTD established in phase 1 will be used.
16239600|NCT01088958|Dietary Supplement|Micronutrient powders (Sprinkles)|"Sprinkles were developed in 1996 by Stanley Zlotkin's research group at the Hospital for Sick Children, University of Toronto as a novel approach for delivering iron and other micronutrients. They come in 1g sachets of dry powder that is then added to any home-prepared semi-solid food, intended for daily consumption by children aged 6-59 months. Formulation includes:
~Iron (Ferrous fumarate) 12.5 mg, Folic acid 150 µg, Vitamin A 375 µg, Vitamin C 35 mg, Zinc 5 mg, Vitamin B1 0.5 mg, Vitamin B2 0.5 mg, Vitamin B6 0.5 mg, Vitamin B12 0.9 µg, Vitamin D3 5 µg, Vitamin E 6.0 mg, Niacin 6.0 mg, Copper 0.6 mg, Iodine 50 µg"
16239601|NCT01088945|Behavioral|Enhanced Discharge process|Health Coaching prior to discharge, with an enhanced discharge binder to reinforce the teaching of the Health Coach
16239602|NCT01088932|Drug|SRX246|capsules
16239603|NCT01088919|Drug|ASP1941|oral tablet
16239604|NCT01088919|Drug|pioglitazone hydrochloride|oral tablet
16239605|NCT01088906|Drug|Pemetrexed/Cisplatin|Pemetrexed 500 mg/m2 IV followed by cisplatin 75 mg/m2 IV every 21 days. A cycle is 21 day.
16239606|NCT01088893|Drug|Everolimus|10mg/d) for three weeks 1 week after completion of neoadjvuant treatment and before surgery
16239607|NCT01088880|Drug|Canakinumab|
16239608|NCT01088867|Other|Acupuncture|Electroacupuncture
16239609|NCT01088854|Device|CPAP|unique session of 30-minute of continuous airway positive pressure
16239610|NCT01088841|Dietary Supplement|lactisole|lactisole (flavoring agent/sweet taste antagonist) dissolved with 75 g glucose in 300 mL tap water; administered via intragastric tube
16239611|NCT01088828|Other|Magnetic Resonance Imaging (MRI) of calf and foot|Detailed 3-D comparison of MRI scans of children with clubfoot and controls without clubfoot in utero, in untreated infants and in older children who have been treated.
16239612|NCT01088815|Drug|Gemcitabine, nab-Paclitaxel, GDC-0449|"One cycle of Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 (28 days cycle) then
~Gemcitabine 1000 mg/m2 and nab-Paclitaxel 125 mg/m2 on days 1, 8, and 15 every 28 days cycle in combination with oral GDC-0449 150 mg daily"
16239613|NCT01088802|Radiation|IMRT|Dose de-escalation (from 70 Gy to 63 Gy and from 58.1 Gy to 50.75 Gy, same number of fractions (N=35) in 7 weeks)
16239614|NCT01088802|Drug|Cisplatin|Cisplatin will be administered weekly for the first 3 weeks and the last 3 weeks of radiation. Patients will not receive chemotherapy during week 4 of treatment.
16239615|NCT01088802|Drug|Carboplatin|Carboplatin will be administered weekly during the 7 weeks of radiation. Carboplatin may be given as a substitution for cisplatin when cisplatin-related toxicities occur or when patients present with greater than grade 2 sensory or motor neuropathy, greater than 2 hearing loss, or less than 60 ml/min creatinine clearance.
16239616|NCT01088789|Biological|PANC 10.05 pcDNA-1/GM-Neo and PANC 6.03 pcDNA-1 neo vaccine.|"A pancreatic vaccine secreting a granulocyte-macrophage colony-stimulating factor(GM-CSF). The vaccine consists of equal numbers of pancreatic cancer cells (Panc 6.03)and (Panc. 10.05) into a single vaccine.
~The vaccine is administered every 6 months."
16239617|NCT01088776|Dietary Supplement|n-3 Fatty Acid supplement|"Children will be prescribed 1600-1800 mg EPA + DHA per m2 Body Surface Area, to a maximum of the upper limit of the age-appropriate range recommended by Health Canada.
~Each n-3FA gel capsule (1000 mg) will contain 400 mg EPA and 200 mg DHA derived from the oil of wild anchovies and sardines. A smaller gel capsule (500 mg; 200 mg EPA + 100 mg DHA) will be available for children unable to swallow large solid medication and a flavored liquid formulation, containing a similar proportion of EPA + DHA (2200 mg fish oil concentrate from anchovies and sardines, 750 mg EPA, 375 mg DHA per ½ teaspoon), will be available for use in toddlers and older children unable to swallow gel capsules."
16239618|NCT01088776|Dietary Supplement|Placebo|The placebo, identical in opaque appearance and citrus-flavored taste, will contain a 50:50 blend of soybean and corn oil for both gel capsule (2 sizes) and liquid formulations.
16239619|NCT01088763|Drug|gamma-secretase/Notch signalling pathway inhibitor RO4929097|Given PO
16239620|NCT01088763|Other|diagnostic laboratory biomarker analysis|Correlative studies
16239621|NCT01088763|Other|pharmacological study|Correlative studies
16239622|NCT01088763|Drug|dexamethasone|Given IV
16239623|NCT01088750|Drug|cyclophosphamide|
16239624|NCT01088750|Drug|prednisolone|
16239625|NCT01088750|Drug|vinblastine sulfate|
16239626|NCT01088750|Other|watchful waiting|
16239627|NCT01088750|Procedure|therapeutic conventional surgery|
16239628|NCT01088737|Drug|Imiquimod|Imiquimod 5% cream is applied once daily. Each patient will begin with the application 3x/week. After two weeks of treatment the inflammation response to imiquimod will be assessed. If no or only minor inflammation is detectable in the treatment area, the dosing schedule will be increased to 5x/week. After four weeks of treatment the inflammation response will be assessed again. If still no or only minor inflammation is detectable, application will be extended to daily use.
16239629|NCT01088724|Drug|fludarabine, cyclophosphamide, doxorubicin, rituximab|Fludarabine i.v.(30 mg/sqm/day,day 1,2,3); Cyclophosphamide i.v.(750 mg/sqm, day 1); Doxorubicin i.v.(30 mg/sqm, day 1); Rituximab i.v. (375 mg/sqm, day 4).
16239630|NCT01088711|Drug|Omarigliptin|Once-weekly 50 mg capsule
16239631|NCT01088711|Drug|Placebo|Once-weekly placebo capsule
16239632|NCT01088698|Radiation|UVB-311nm radiation|UVB-311nm radiation given 3 times a week to one randomized body-half
16239633|NCT01088685|Device|Experimental Blister Patch|Experimental hydrogel blister patch to be applied as needed (at least every 2 days) consecutively until blister heals
16239634|NCT01088685|Device|Marketed Pflaster|Foot Blister Patch to be applied as needed (at least every 2 days) until blister heals
16239635|NCT01088672|Procedure|Mechanical Thrombectomy|The Trevo device is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke.
16239636|NCT01088659|Drug|peginterferon alfa-2a [Pegasys]|180mcg sc weekly, 96 weeks
16239637|NCT01088659|Drug|placebo|orally daily, 96 weeks
16239638|NCT01088659|Drug|tenofovir|245mg po daily, 96 weeks
16239665|NCT01088451|Drug|Combined prandial insulin therapy (CPIT)|Combined prandial insulin therapy (CPIT) applies individual combination of rapid insulin analogue and human insulin according subject's individual estimation of the type of carbohydrates in concrete mixed-meal, based on thorough education. In this study subjects use two applicators, giving two injections before main meals as per basal-bolus therapy. Insulin aspart (Novorapid, Novo Nordisk) and human insulin (Actrapid, Novo Nordisk) are used.
16239639|NCT01088646|Device|PillCam® Express Capsule Endoscopy Delivery System|"The PillCam® Express Capsule Endoscopy Delivery System is comprised of three parts: a catheter, a syringe and the capsule holder. The catheter is passed through the accessory channel of a standard endoscope and the capsule holder is snapped on to the distal end of the device. The endoscope is used to guide the Capsule Endoscopy Delivery System to the proximal duodenum. The capsule is then released pneumatically, using an air-filled syringe attached to the proximal end of the catheter.
~Once the capsule is deployed, the endoscope is withdrawn and the capsule holder is cut off at the distal part of the device with scissors. The catheter is then retracted and discarded.
~The PillCam® Express Capsule Endoscopy Delivery System is single-use, disposable and latex-free."
16239640|NCT01088633|Other|Exhaled particle analysis|"At visit 2, the exhaled particle analysis will be performed. Subjects will be asked to breath through the device and to perform several breathing maneuvers such as deep breathing, shallow breathing, rapid breathing, slow breathing. These measurements will be repeated after 2 hours on the same day.
~Visit 3:
~After a baseline exhaled particle analysis, the subjects will inhale nebulized saline (2.5 ml of a 0.9 % NaCl-solution). Aerosol generation and transport will be recorded immediately after the end of inhalation as well as 2 hours and 4 hours after the start of inhalation using the same techniques as in visit 2."
16239641|NCT01088620|Drug|Panitumumab|"Panitumumab 9 mg/kg BW will be administered IV every 3 weeks (q3w) for a maximum of four cycles.
~In case of CR, PR or SD status at the end of the combination treatment, a panitumumab single drug treatment, consisting of 9 mg/kg BW administered every 3 weeks, will be performed until detection of disease progression."
16239642|NCT01088620|Drug|Pemetrexed|Pemetrexed 500 mg/m² will be administered IV every 3 weeks (q3w) for a maximum of four cycles.
16239643|NCT01088620|Drug|Cisplatin|Cisplatin 75 mg/m² will be administered IV every 3 weeks (q3w) for a maximum of four cycles.
16239644|NCT01088607|Drug|ursodeoxycholic acid (UDCA)|Pediatric PSC patients already receiving UDCA therapy will enter a four-phase trial consisting of baseline data collection (phase I, 4 weeks), 50% reduction in UDCA dose (phase II, 4 weeks), discontinuation of UDCA (phase III, 8 weeks) and reinstitution of therapy at a dose of 20 mg/kg/day (phase IV, 8 weeks). Surveillance and endpoint evaluation for each phase will include liver chemistries and clinical data. Comparisons will be made between baseline and the end of phase III (primary outcome) and between the end of phase III and the end of phase IV (secondary outcome). Serum cytokine biomarkers will be measured and compared between baseline and the end of phase III and between the end of phases III and IV.
16239645|NCT01088594|Drug|pioglitazone/rosiglitazone/placebo|single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg +single oral dose of placebo
16239646|NCT01088594|Drug|rosiglitazone/pioglitazone/placebo|single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg + single oral dose of placebo
16239647|NCT01088594|Drug|placebo/pioglitazone/rosiglitazone|single oral dose of placebo + single oral dose of pioglitazone 45mg + single oral dose of rosiglitazone 8mg
16239648|NCT01088594|Drug|pioglitazone/placebo/rosiglitazone|single oral dose of pioglitazone 45mg +single oral dose of placebo + single oral dose of rosiglitazone 8mg
16239649|NCT01088594|Drug|rosiglitazone/placebo/pioglitazone|single oral dose of rosiglitazone 8mg + single oral dose of placebo + single oral dose of pioglitazone 45mg
16239650|NCT01088594|Drug|placebo/rosiglitazone/pioglitazone|single oral dose of placebo + single oral dose of rosiglitazone 8mg + single oral dose of pioglitazone 45mg
16239651|NCT01088581|Drug|Adjuvant group|Adjuvant chemotherapy (5FU and cisplatin) after resection
16239652|NCT01088568|Procedure|the implantation of toric implantable collamer lens|perform the implantation of toric implantable collamer lens for both eyes
16239653|NCT01088568|Procedure|customized laser-assisted in situ keratomileusis|perform Q-factor customized laser-assisted in situ keratomileusis for both eyes
16239654|NCT01088555|Drug|Sodium thiosulfate|Oral administration of sodium thiosulfate pentahydrate 5% solution (American Regent) 10ml BID x 7 days
16239655|NCT01088542|Behavioral|Communities That Care|The Communities That Care (CTC) system provides communities training and ongoing technical assistance in a structured process for conducting prevention needs assessments using epidemiological data on levels of risk and protective factors for adolescent problem behaviors, selection of tested and effective preventive interventions shown to address community-prioritized factors, implementation of these interventions with fidelity, and evaluation of the community's progress toward its goals. The CTC system is designed to produce a plan for prevention services that is tailored to the needs of each community. CTC is installed in five phases through a manualized series of training events designed to build the capacity of communities to install and sustain the system over time.
16239656|NCT01088529|Drug|Abiraterone Acetate|1000 mg oral daily for 3 months followed by a prostatectomy.
16239657|NCT01088529|Drug|Prednisone|5 mg orally daily.
16239658|NCT01088529|Drug|LHRHa|LHRH analogue (either leuprolide or goserelin): Leuprolide is an intramuscular injection, and goserelin subcutaneous (under skin) of abdomen, given either 1 injection every 3 months or 1 injection each month for 3 months.
16239659|NCT01088516|Drug|Lopinavir/Ritonavir (200/50 mg) Tablets + Zidovudine + 3TC|Zidovudine 300mg PO BID + 3TC 150 mg PO BID + Lopinavir/Ritonavir (200/50 mg) two tablets PO BID
16239660|NCT01088503|Drug|ADP receptor inhibitors|Dosage regimen as determined by the treating physician.
16239661|NCT01088477|Other|Diagnostic intervention: Positron Emission Tomography with 16-alpha-[18-fluoro]-17betaestradiol|In patients with acquired antihormonal resistance, eligible for estrogen therapy, a FES-PET scan will be made to determine FES-PET tumor uptake (which corresponds to estrogen receptor expression levels). Immediately after the FES-PET scan, all patients will start with a standard accepted dose of 2mg estradiol TID. Therapy response will be monitored by regular follow-up. RECIST criteria and clinical benefit will be used as criteria. In case of disease progression before end of the study period, estradiol treatment will be stopped.
16239662|NCT01088464|Biological|IMC-11F8|600 milligrams (mg) intravenously, Days 1 and 8 every 3 weeks
16239663|NCT01088464|Biological|IMC-11F8|800 mg intravenously, every 2 weeks
16239664|NCT01088464|Biological|IMC-11F8|800 mg intravenously, Days 1 and 8 every 3 weeks
16239666|NCT01088438|Behavioral|Contextualization workshop|A four-hour course on contextualization.
16239667|NCT01088425|Other|Observation|"Alberta infant motor scale
~Griffiths test
~Kauffmann ABC"
16239668|NCT01088412|Drug|Somatropin (recombinant deoxyribonucleic acid [rDNA] origin)|Dose, frequency and duration at discretion of attending physician.
16239673|NCT01088347|Radiation|radiotherapy|Radiotherapy: a total dose of 45 Gy will be given in fractions of 1.8 Gy, five fractions per week (days 8-12, 15-19, 22-26, 29-33, and 36-40), by external beam irradiation by photon beam of at least 6 MV. After completing the five weeks of external beam irradiation, evaluation will take place to determine whether the boost can be given by brachytherapy. If brachytherapy is not feasible, the boost will be given by external beam irradiation to a total dose of 70.2 Gy in fractions of 1.8 Gy.
16239674|NCT01088334|Other|screening|CT-Chest/abdomen and mammography in women
16239675|NCT01088308|Procedure|High rate atrial and vetricular stimulation|The right atria and ventricle of the subject will be electrically stimulated at high rate mimicking tachycardia episodes using electrodes placed in the right atria and ventricle.
16239676|NCT01088308|Procedure|Ventricular Tachycardia induction|A programmed electrical stimulation protocol will be performed using an electrode placed in the right ventricle.
16239677|NCT01088295|Drug|Telmisartan|
16239678|NCT01088282|Procedure|Cataract surgery|Implantation of multifocal or monofocal IOL
16239679|NCT01088256|Drug|Etoricoxib|the patients get etoricoxib 90mg for 8 days. They get one pill with 90mg per day
16239680|NCT01088256|Drug|placebo|patients get one pill of placebo (sugar-pill) per day for 8 days.
16239681|NCT01088243|Drug|Mesalamine|Mesalamine (5-ASA) 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.
16239682|NCT01088243|Drug|Placebo|Sugar pill 500 mg capsules four times per day for 6 weeks in Chronic Beryllium Disease subjects.
16239683|NCT01088230|Other|Botox®|the treatment group will receive a one time injection of Botox® at the wrist flexors and pronators of the affected arm. Each subject will receive a standard dose of 150 units total, 50u each to the flexor carpi radialis and flexor carpi ulnaris, and 25u each for the pronator teres and pronator quadratus muscle groups.
16239684|NCT01088230|Other|saline solution|the control group will receive a one time injection of salt water in the flexor carpi radialis and flexor carpi ulnaris, and the pronator teres and pronator quadratus muscle groups.
16239685|NCT01088204|Procedure|laparoscopy assisted distal gastrectomy|laparoscopy assisted distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer
16239686|NCT01088204|Procedure|open distal gastrectomy|open distal gastrectomy with D2 lymph node dissection for patients with advanced gastric cancer
16239687|NCT01088191|Biological|MSB-CAR001 Combined With Hyaluronan|"Knee Injection of Biological: MSB-CAR001 Combined With Hyaluronan
~Single Injection Into the Knee Joint of Single Doses of MSB-CAR001 Combined With Hyaluronan"
16239688|NCT01088191|Drug|Hyaluronan|Hyaluronan alone
16239689|NCT01088178|Device|Levonorgestrel Intrauterine System (LNG-IUS: Mirena, Bayer)|Placement of Mirena at given intervals during the postpartum period
16239690|NCT01088165|Drug|Adalimumab treatment arm|Adalimumab: day 1: 2x40 mg s.c., day 8: 40 mg s.c., thereafter 40 mg s.c. in biweekly intervals
16239691|NCT01088165|Drug|Fumaric acid esters treatment group|"First week:FAE mite (DIMETHYL FUMARATE 30mg, ETHYL FUMARATE CALCIUM 87mg, ETHYL FUMARATE ZINC 3mg, ETHYL FUMARATE MAGNESIUM 5mg):day 1 and 2: 0-0-1, day 3 and 4: 1-0-1, day 5-7: 1-1-1).
~Week 2: FAE forte (DIMETHYL FUMARATE 120mg ETHYL, FUMARATE CALCIUM 87mg, ETHYL FUMARATE ZINC 3mg, ETHYL FUMARATE MAGNESIUM 5mg)starting with 0-0-1 capsule daily, thereafter weekly increases by on capsule until maximum daily dose 2-2-2. In the event of side effects (in particular, gastrointestinal disturbances or flushing) adaption of the dose (reduction or no increase) depending on the type and severity of the side effect will be performed. If remission occurs at a lower than the maximum dose that dose will be maintained throughout the rest of the study period."
16239692|NCT01088165|Other|Narrow band UVB radiation|"No reduction of 50% minimum of baseline psoriasis severity index by week 12: additional narrow band UVB radiation, 3x/week until the patients achieve PASI reduction of 75% or greater or over a maximum period of another 12 weeks.
~Initial dosage: Fitzpatrick skin phototype I and II: 0,4 J/cm2, III and IV: 0,6), 10% Increments after each radiation"
16239693|NCT01088152|Behavioral|Celiac school|Structured education of adult celiac patients at 10 sessions.
16239694|NCT01088152|Behavioral|Usual care of celiac disease women|Written information corresponding to that offered when seeking medical advice for well treated celiac disease in the primary care.
16239695|NCT01088139|Dietary Supplement|Protein supplementation|Ready made protein supplement drinks with approximate protein content of 18-24g per 500ml per day. Caloric content is 490 to 530Kcal depending on the brand of drink.
16239696|NCT01088126|Procedure|radiofrequency catheter ablation|radiofrequency catheter ablation, NavX system
16239697|NCT01088100|Genetic|Genotyping|Determination of 3 types of clock gene genotypes (HPER 4/4, 5/4, 5/5) on all blood samples
16239698|NCT01088087|Dietary Supplement|colostrum|colostrum, 2g, 2 times a day, for 3 weeks
16239699|NCT01088074|Device|Histoacryl Tissue Adhesive|
16239700|NCT01088074|Device|Dermabond|
16239701|NCT01088074|Device|Staples|
16239702|NCT01088074|Device|Monocryl 4-0|
16239703|NCT01088048|Drug|Idelalisib|Idelalisib tablet administered orally
16239704|NCT01088048|Drug|Rituximab|Rituximab administered intravenously
16239705|NCT01088048|Drug|Bendamustine|Bendamustine administered intravenously
16239706|NCT01088048|Drug|Ofatumumab|Ofatumumab administered intravenously
16239707|NCT01088048|Drug|Fludarabine|Fludarabine administered orally
16239708|NCT01088048|Drug|Everolimus|Everolimus administered orally twice daily until disease progression
16239709|NCT01088048|Drug|Bortezomib|Bortezomib administered as a subcutaneous injection
16239710|NCT01088048|Drug|Chlorambucil|Chlorambucil administered on Days 1-7 every 28 days to allow appropriate therapy for participants with CLL and to coordinate into a cycle period equivalent to other study treatment regimens.
16239711|NCT01088048|Drug|Lenalidomide|Lenalidomide administered orally
16239712|NCT01088035|Drug|Carboplatin|Patients will receive daily carboplatin as a radiation sensitizer prior to radiation each day.
16239713|NCT01088022|Drug|Aprepitant, Palonosetron, Dexamethasone|Aprepitant 125-mg capsule 80-mg capsule 80-mg capsule Palonosetron 0.25 mg i.v. Dexamethasone 8 mg i.v. 8 mg os 8 mg os
16239714|NCT01088022|Drug|Placebo, Palonosetron, Dexamethasone|Aprepitant 125-mg placebo capsule 80-mg placebo capsule 80-mg placebo capsule Palonosetron 0.25 mg i.v. Dexamethasone 8 mg i.v. 8 mg os 8 mg os
16239756|NCT01087762|Biological|CZP 200 mg Q2W|200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
16239715|NCT01088009|Drug|lamivudine|patients in this arm will receive oral lamivudine 100mg,daily for 24 weeks; if patients with HBV DNA higher than 1000 copies/ml at week 24, add on adefovir to week 104; otherwise, keep lamivudine monotherapy to week 104
16239716|NCT01088009|Drug|lamivudine|Patients will receive oral lamivudine 100mg,daily for 104 weeks, if HBV DNA breakthrough, add on oral adefovir 10mg daily
16239717|NCT01088009|Drug|lamivudine, adefovir|patients in this arm will receive oral lamivudine 100mg daily and adefovir 10mg for 104 weeks
16239718|NCT01087996|Biological|Auto-hMSCs|Biological: Autologous human mesenchymal stem cells (Auto-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Auto-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Auto-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Auto-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
16239719|NCT01087996|Biological|Allo-hMSCs|Biological: Allogeneic human mesenchymal stem cells (Allo-hMSCs) Participants will receive 40 million cells/mL delivered in either a dose of 0.5 mL per injection x 1 injection for a total of 0.2 x 10^8 (20 million) Allo-hMSCs, a dose of 0.5 mL per injection x 5 injections for a total of 1 x 10^8 (100 million) Allo-hMSCs, or a dose of 0.5 mL per injection x 10 injections for a total of 2 x 10^8 (200 million) Allo-hMSCs. The injections will be administered transendocardially during cardiac catheterization using the Biocardia Helical Infusion Catheter.
16239720|NCT01087983|Drug|Lapatinib|Starting oral dose of 500 mg daily for 21 day cycle.
16239721|NCT01087983|Drug|Sirolimus|Starting oral dose 1 mg daily.
16239722|NCT01087983|Drug|Metformin|Starting oral dose 1000 mg daily.
16239723|NCT01087970|Drug|Pemetrexed|Administered intravenously, for maximum of 6 cycles.
16239724|NCT01087970|Drug|Cetuximab|"Administered intravenously in combination therapy, for a maximum of 6 cycles.
~After the completion of 6 cycles, participants who have not experienced disease progression will continue on cetuximab monotherapy until disease progression."
16239725|NCT01087970|Drug|Carboplatin|Administered intravenously, for a maximum of 6 cycles
16239726|NCT01087970|Drug|Cisplatin|Administered intravenously, for a maximum of 6 cycles
16239727|NCT01087957|Device|WalkAide|Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
16239728|NCT01087957|Other|Ankle-Foot Orthosis (AFO)|Comparison of WalkAide device against Ankle-Foot Orthosis (AFO)
16239729|NCT01087944|Device|Autoinjector|Participants received Peginterferon alfa-2a 180 microgram subcutaneously once a week by autoinjector for 3 weeks.
16239730|NCT01087944|Device|Pre-filled syringe|Participants received Peginterferon alfa-2a 180 microgram subcutaneously once a week by pre-filled syringe for 3 weeks.
16239731|NCT01087931|Drug|Bupivacaine|Single application of 10ml of bupivacaine 0.5% into the iliac crest bone harvest surgical site.
16239732|NCT01087931|Other|Normal Saline|Normal saline 0.9%, 10ml, single application directly into iliac crest bone harvest surgical site.
16239733|NCT01087918|Device|RAGT|16 sessions / 4 times/week / 45 minutes Lokomat training
16239734|NCT01087918|Other|Strength Training|16 sessions / 4 times/week / 45 minutes lower extremity strength training
16239735|NCT01087905|Drug|Nicotine patch|"If > 10 cigs/day: one 21 mg nicotine patch per day
~If < or = 10 cigs/day: one 14 mg nicotine patch per day"
16239736|NCT01087905|Drug|Nicotine gum|"If < 25 cigs/day, 2 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects.
~If ≥ 25 cigs/day, 4 mg nicotine gum, at least 5 pieces of oral NRT per day (maximum of 1 piece every 1-2 hours), unless this amount of use produces nicotine toxicity effects."
16239737|NCT01087905|Behavioral|CMAC|CMAC consists of tailored cessation counseling to improve medication adherence during the counseling calls. The CMAC protocol was developed by study investigators and involved: (1) pre-quit assessment of beliefs that might undermine NRT adherence; (2) on-going medication adherence assessment by quitline Quit Coaches; and (3) tailored coaching based on the ongoing assessments.
16239738|NCT01087892|Dietary Supplement|Probiotic drink containing the live strain|Probiotic drink contains no strain
16239739|NCT01087892|Dietary Supplement|placebo probiotic|Placebo product is a sweetened flavoured, non fermented, acidified dairy drink
16239740|NCT01087879|Drug|Desogestrel-Ethinyl Estradiol contraceptive pill|150 microg Desogestrel and 20 microg Ethinyl Estradiol combination. One pill once a day for 9 weeks, continual administration.
16239741|NCT01087879|Drug|Etonogestrel-Ethinyl Estradiol vaginal ring|Etonogestrel-Ethinyl Estradiol vaginal ring, which consists of 11,7 mg etonogestrel and 2,7 mg ethinyl estradiol. It delivers 0,120 mg etonogestrel and 0,015 mg ethinyl estradiol per day. Treatment continues continual for 9 weeks and the vaginal ring is changed every three weeks.
16239742|NCT01087879|Drug|Norelgestromin-Ethinyl Estradiol contraceptive patch|A combination transdermal contraceptive patch with 6 mg of norelgestromin and 600 microg of ethinyl estradiol. It delivers 203 microg of norelgestromin and 33,9 microg ethinyl estradiol per day. A continual use of patch for 9 weeks and the patch is changed every week.
16239743|NCT01087866|Drug|Metformin|
16239744|NCT01087866|Drug|Insulin|
16239745|NCT01087853|Drug|Crystalloid|2 litres intravenous infusion in 60 minutes
16239746|NCT01087853|Drug|Colloid|1 litre intravenous infusion over 30 minutes
16239747|NCT01087840|Drug|Raltegravir|"Drug: Raltegravir tablet 400mg is taken orally, twice daily with or without food for 28 days along with Tenofovir disoproxil fumarate/emtricitabine 300mg/200mg 1 tablet taken orally once daily with or without food for 28 days.
~Arms: Raltegravir/Truvada Other Names: Isentress/Truvada"
16239748|NCT01087814|Drug|Efavirenz|Subject will take efavirenz for 5 days.
16239749|NCT01087814|Drug|Over-encapsulated efavirenz|Subject will take efavirenz that has been over-encapsulated with a gel capsule for 5 days.
16239750|NCT01087801|Drug|ChiRhoStim|Human Secretin for Injection
16239751|NCT01087801|Drug|Placebo|Saline for Injection
16239752|NCT01087788|Biological|CZP 200 mg Q2W|200 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 2 weeks (Q2W).
16239753|NCT01087788|Biological|CZP 400 mg Q4W|400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
16239754|NCT01087788|Other|Placebo|Matching Placebo to CZP injection.
16239755|NCT01087775|Behavioral|Cognitive Training|Plasticity Based Adaptive Cognitive Remediation (PACR)
16239757|NCT01087762|Biological|CZP 400 mg Q4W|400 mg subcutaneous (sc) injection of Certolizumab Pegol (CZP) every 4 weeks (Q4W).
16239758|NCT01087762|Other|Placebo|Matching Placebo to CZP injection.
16239759|NCT01087749|Drug|Propranolol|Propranolol 40mg PO will be given with 6oz of water.Blood samples will be obtained for 12 hours to determine the medication concentration in the plasma. There is no therapeutic effect on this study, since patients will receive a low single dose of the medication, and we'll assess the different pharmacokinetic parameters based on the concentrations of the medicine in plasma.
16239760|NCT01087749|Drug|Losartan|Losartan 50mg PO will be given with 6oz of water. Blood samples will be obtained for 12 hours to determine the medication concentration in the plasma. There is no therapeutic effect on this study, since patients will receive a low single dose of the medication, and we'll assess the different pharmacokinetic parameters based on the concentrations of the medicine in plasma.
16239761|NCT01087749|Drug|Eprosartan|Erythromycin 125mg PO will be given with 6oz of water. Blood samples will be obtained for 12 hours to determine the medication concentration in the plasma. There is no therapeutic effect on this study, since patients will receive a low single dose of the medication, and we'll assess the different pharmacokinetic parameters based on the concentrations of the medicine in plasma.
16239762|NCT01087736|Drug|Topiramate|After random assignment, topiramate will be titrated up over 5 weeks. Dosing begins at 25 mg per day, and increase in the second week to 25 mg twice per day; in the third week to 50 mg twice/day; in the fourth week to 75 mg twice/day; in the 5th week to 100 mg twice/day; and in weeks 6-11 increased to and maintained at 100 mg in the morning and 200 mg at night. Patients will receive the highest dose tolerated, not to exceed 300 mg per day. Adjustments are permitted throughout titration. Once maximum tolerated dosage is reached, subjects will be asked to maintain dosage for remainder of the treatment phase. Upon completing the 6 week maintenance period subjects will taper off over a 7-day period (Week 12). If subjects experience significant side effects, the dosage may be adjusted.
16239763|NCT01087736|Other|Placebo administration|Placebo pills will be prepared by the UCSF pharmacy which will be indistinguishable from the topiramate pills used in that arm. Both topiramate and placebo will then be delivered to the VA pharmacy. A consulting biostatistician will randomly assign participants to either the topiramate or placebo group. The dosing of placebo pills will follow the same regimen as outlined for the topiramate arm. In the event of a safety issue, there will be a procedure for unblinding only that participant.
16239764|NCT01087723|Drug|Bivalirudin|
16239765|NCT01087723|Drug|Heparin|
16239766|NCT01087710|Other|medical food with EPA and GLA, vitamins and minerals|1 8oz serving per day for 12 weeks
16239767|NCT01087710|Other|medical food minus EPA and GLA, antioxidant vitamins/minerals|1 8oz serving a day for 12 weeks
16239768|NCT01087697|Device|Neo-Urinary Conduit|Implantation with the autologous Neo-Urinary Conduit
16239769|NCT01087684|Procedure|Argon laser trabeculoplasty|Argon laser 600-800 mW, 0.1seconds, 50 micron spot size, 45 - 55 burns over 180 degrees of trabecular meshwork
16239770|NCT01087684|Procedure|Selective laser trabeculoplasty|Selective laser trabeculoplasty 0.7 - 0.8 mJ, 400 micron spot size, 3 nanosecond, 45 - 55 burns over 180 degrees of trabecular meshwork.
16239771|NCT01087671|Drug|tafluprost|prostaglandin analogue
16239772|NCT01087658|Drug|Glutamine|Per os
16239773|NCT01087658|Drug|Calcium and Magnesium|Intravenous
16239774|NCT01087645|Drug|NN9925 (oral)|Subjects will be randomised to receive a single dose of NN9925, at escalating dose levels. Progression to next dose will be based on safety evaluation
16239775|NCT01087645|Drug|NN9925 (i.v.)|As an active comparator, one standard dose will be given i.v. (into the vein) at one study visit
16239776|NCT01087645|Drug|placebo|Subjects will receive a single dose of placebo as a comparator to NN9925, at all dose levels
16239777|NCT01087645|Drug|NN9925 (oral)|Subjects will be randomised to receive a single dose of NN9925 in up to three different concentrations. The dose will be selected based on the results of part 1
16239778|NCT01087645|Drug|placebo|Subjects will be randomised to receive a single dose of placebo
16239779|NCT01087632|Dietary Supplement|Armolipid Plus|Armolipid Plus 1 tablet QD for 18 weeks
16239780|NCT01087619|Procedure|Parathyroid surgery|Parathyroid Surgery (regardless of surgical strategy; i.e., focused operation, unilateral- or bilateral neck exploration)
16239781|NCT01087593|Drug|17β-estradiol|Transdermal administration(50 ug daily)for a period of ten weeks with additional treatment of medroxyprogesterone (10mg daily) for the last two weeks
16239782|NCT01087580|Drug|Docetaxel and Prednisone|A) Docetaxel: 75 mg/m2 IV infusion over 1 hour on day 1 of each cycle every 21 days B) Prednisone: 10 mg orally for 21 days after each dose of docetaxel
16239783|NCT01087580|Drug|Docetaxel and Prednisone|A) Docetaxel: 75 mg/m2 IV infusion over 1 hour on day 1 of each cycle every 21 days B) Prednisone: 10 mg orally for 21 days after each dose of docetaxel
16239784|NCT01087580|Drug|Radiation Therapy|"GROUPS 1 and 2 Whole Pelvis (45 Gy) + Prostate boost (20-25 Gy) in 1.8 Gy fractions, 5 fractions/week.
~GROUPS 2 Bone metastasis (bone scan index < 1.4%): 30 Gy in 10 fractions or 35 Gy in 12 fractions.
~GROUPS 1,2 Abdominal Nodes (IF POSITIVE ON CT/MRI SCAN): 45-50 Gy in 1.8 Gy fractions, 5 fractions/week."
16239785|NCT01087567|Drug|Intensive insulin|A weight-based basal bolus insulin regimen starting with 0.1 units/kg/day of Glargine and 4 units/meal of Glulisine.
16239786|NCT01087567|Drug|Routine Care|Treatment in routine care will be based upon the 2009 ADA treatment recommendations.
16239787|NCT01087554|Drug|Sirolimus|"Escalation Phase: Sirolimus starting dose1 mg by mouth on Days 1 - 28.
~Expansion Phase starting dose: MTD from Escalation Phase."
16239788|NCT01087554|Drug|Vorinostat|"Arm A - Escalation Phase: Vorinostat starting dose 100 mg by mouth on Days 7 - 28 of Cycle 1; For all other cycles, dose of 100 mg Days 1-28.
~Expansion Phase starting dose: MTD from Escalation Phase.
~Arm B + Arm C - Escalation and Expansion Phase: Vorinostat dose 300 mg by mouth on Days 7 - 28. Rest of cycles: 300 mg by mouth on Days 1 - 28."
16239789|NCT01087554|Drug|Everolimus|"Escalation Phase: Everolimus starting dose 5 mg by mouth on Days 1 - 28.
~Expansion Phase: MTD from Escalation Phase."
16239790|NCT01087554|Drug|Temsirolimus|"Escalation Phase: Temsirolimus starting dose 12.5 mg by vein on Days 1, 8, 15, 22.
~Expansion Phase: MTD from Escalation Phase."
16239791|NCT01087541|Behavioral|Educational program 6-hour standardized|6-hour standardized program for adults ( doctors and nurses )
16239792|NCT01087528|Device|PillCam™ (Capsule Endoscopy) Colon 2 capsule|Medical Device
16239793|NCT01087515|Other|Blood donation|"In experimental part 1 to generate preclinical data 250 ml of blood will be donated at day 1 by 10 subjects to induce allergen presenting cells (APCs).
~In experimental part 2 to transfer the isolation of pDC or TREGs to a GMP (good manufacturing Practice) compliant clinical grade isolation system, leukapheresis will be performed with the blood from 5 subjects.
~In experimental part 3 for potency testing of the clinical grade isolation system of pDC or TREGs, 250 ml of blood will be collected at day 1 from 3 subjects."
16239794|NCT01087502|Drug|Glimepiride|1-4 mg daily after 12 weeks
16239795|NCT01087502|Drug|Placebo|Placebo mach to 5 mg linagliptin first 12 weeks of treatment once daily
16239796|NCT01087502|Drug|Placebo|Placebo maching Glimepiride 1-4 mg after 12 weeks of treatment
16239797|NCT01087502|Drug|Placebo|Placebo mach to 5 mg linagliptin once daily after 12 weeks
16239798|NCT01087502|Drug|Linagliptin|5 mg once daily
16239799|NCT01087489|Drug|4% lidocaine|The eye will be topically anesthetized with 0.5% proparacaine drops and 4% lidocaine drops and a 10% povidone-iodine scrub of the lids and lashes will be performed. A sterile speculum will be placed between the lids. Five percent povidone-iodine drops will then be applied over the ocular surface followed in three rounds by additional 5% povidone iodine and a sterile cotton swab soaked in sterile 4% lidocaine applied with gentle pressure to the area designated for injection in the infero-temporal quadrant.
16239800|NCT01087489|Drug|3.5% ophthalmic lidocaine gel|The eye will be topically anesthetized with 0.5% proparacaine drops and 5% povidone iodine will be placed over the eye. Two drops of preservative-free 3.5% lidocaine hydrochloride ophthalmic gel will be placed into inferior conjunctival sac. The patient will be asked to close the eye for 7 minutes. Next, a 10% povidone-iodine scrub of the lids and lashes will be performed. A sterile speculum will be placed between the lids. Five percent povidone-iodine drops will then be applied over the ocular surface and allowed to remain in contact with the eye for at least 2 minutes. The eye will then be rinsed with antibiotic drops.
16239801|NCT01087476|Drug|Doxycycline hyclate|Sub-microbial dose of Doxycycline hyclate or placebo (50 mg per day), immediately before the initiation of induction chemotherapy and daily during the following 21 days after chemotherapy.
16239802|NCT01087463|Device|Quantum|Treatment of humerus fracture (according to the mentioned indications) with the Quantum Intramedullary Nailing System.
16239803|NCT01087437|Dietary Supplement|gastrolith calcium|
16239804|NCT01087424|Drug|R mini CHOP|Prednisone 40 mg/m2 D1 D2 D3 D4 D5 Rituximab 375 mg/m2 D1 Doxorubicine 25 mg/m2 D1 Cyclophosphamide 400 mg/m2 D1 Vincristine 1 mg/m2 D1
16239805|NCT01087411|Behavioral|Motivational Interviewing|The method motivational interviewing according to Miller and Rollnik is used as an behavioral intervention to support the child and family in their own behavioral change towards a more physically active life style.
16239806|NCT01087411|Behavioral|Physical activity|Group sessions with different kinds of physical activity is arranged for the participants in the intervention program.
16239807|NCT01087411|Dietary Supplement|Supplementation with fish liver oli capsules|This group will receive capsules containing omega-3 and omega-6 fatty acids and vitamine E. The dosage is six capsules daily containing omega-3 (558 mg of eico-pentaenoic-acid, EPA, and 174 mg of docosahexaenoic acid, DHA), omega-6 (60 mg of γ-linolenic acid, GLA) plus 9.6 mg vitamin E (in natural form, d-α-tocopherol), gelatin and glycerol. Participants will be instructed to eat three capsules each morning and evening.
16239808|NCT01087411|Dietary Supplement|Placebo oil capsules|This group will receive capsules containing rape seed oil. Participants will be instructed to lead their life in the same manner as before the intervention but eat three capsules each morning and evening.
16239809|NCT01087398|Drug|Busulfan, Cyclophosphamide, Thymoglobulin, Fludarabine (Conditioning regimen)|"For sibling full match:
~Busulfan 16 mg/kg >5year - 20 mg/kg <5year po
~Cyclophosphamide 200 mg/kg iv
~For other related full match, sibling or other related with one antigen mismatch and umbilical cord blood:
~Busulfan 16 mg/kg >5year - 20 mg/kg <5year po
~Cyclophosphamide 200 mg/kg iv
~ATG rabbit (Thymoglobulin) 10 mg/kg or ATG horse (Atgam) 40 mg/kg
~For haploidentical:
~Busulfan 16 mg/kg >5year - 20 mg/kg <5year po
~Cyclophosphamide 200 mg/kg iv
~Fludarabine 160 mg/m^2"
16239810|NCT01087398|Procedure|Stem Cell Transplantation|"Patients undergoing Hematopoietic Stem Cell Transplantation from one of below source:
~Sibling full match
~Other related full match
~Sibling or other related with 1 mismatch antigen
~Cord Blood
~Haploidentical"
16239811|NCT01087398|Drug|Cyclosporin, Methotrexate (GVHD prophylaxis)|"Cyclosporin A 1.5 mg/kg/day iv from -2, then 3 mg/kg/day iv (from +7 in PBSCT and +11 in BMT or UCBT) then 9 mg/kg/day po
~10 mg/m^2 iv day +1 then 6 mg/m^ iv day +3 and +6 (Not for UCBT)"
16239812|NCT01087359|Drug|Melatonin|100 mg melatonin is tested on human endotoxaemia administrated on night and day time compared to placebo
16239817|NCT01087268|Other|questionnaire administration|
16239818|NCT01087268|Procedure|gastrointestinal complications management/prevention|
16239819|NCT01087268|Procedure|quality-of-life assessment|
16239820|NCT01087255|Device|Electronic Pillbox Monitoring System|Daily exposure for six months
16239821|NCT01087242|Drug|Tang-min Lin pill|Tang-min Lin pill 6g,tid,treat 12 weeks.
16239822|NCT01087229|Drug|equimolar oxygen-nitrous oxide mixture|Kinesitherapy is performed with a mask by which patient inhales an equimolar oxygen-nitrous oxide mixture.
16239823|NCT01087229|Drug|Placebo|Kinesitherapy is performed with a mask by which patient inhales a placebo.
16239824|NCT01087216|Device|Group Laser = Arm A|Opposite side lesions that will receive only the treatment by topical steroids and UVB phototherapy
16239825|NCT01087216|Drug|Bras B : The group control|patient to accept habitual treatment of corticoid Opposite side lesions that will receive only the treatment by topical steroids
16239826|NCT01087203|Biological|Tanezumab|20 mg subcutaneous injection every 8 weeks x 2 doses (at Baseline and week 8)
16239827|NCT01087203|Biological|placebo|Placebo to match tanezumab 20 mg subcutaneous injection every 8 weeks x 2 doses (at Baseline and week 8)
16239828|NCT01087190|Drug|Isoniazid treatment|isoniazid 300 mg po qd for 9 months
16239829|NCT01087177|Other|Exposure to practice that has been trained in Pedialink CEASE|Child has had an appointment at a practice that was trained in Pedialink CEASE at the time of the interview.
16239830|NCT01087164|Behavioral|Compliance|Parent will either receive a high or no compliance condition where each is asked to endorse the importance of prevention cervical cancer or genital warts depending on their teen's gender.
16239831|NCT01087164|Behavioral|Message sidedness|Parent will receive either a one-sided or two-sided message about the HPV vaccine
16239832|NCT01087151|Drug|ABT-263|Oral repeating dose
16239833|NCT01087151|Drug|rituximab|Intravenous repeating dose
16239834|NCT01087138|Behavioral|exercise|exercise class 3x's/week
16239835|NCT01087138|Behavioral|exercise and calcium|exercise class 3x's/week and 1500mg calcium intake
16239836|NCT01087125|Drug|No Interventions|No Interventions
16239837|NCT01087112|Behavioral|Mother-Infant Psychoanalytic tmt|Psychoanalytic sessions with mother and infant, at a median of 23 sessions 2 times weekly.
16239838|NCT01087112|Behavioral|Child Health Centre care|Nurse calls at Child Health Centres (CHC), with regular paediatric checkups. The nurse was encouraged to promote attachment and to detect postnatal depressions. Appointments with a psychiatrist or therapist or child psychiatric psychologist was initiated in 1/3 of the cases. This was registered at the end-point interview.
16239839|NCT01087099|Drug|Albendazole|Treatment with albendazole
16239840|NCT01087086|Behavioral|Crononutrition|"After the recruitment and selection of the study participants, the study will consists of a 2-month nutritional intervention (Crononutrition versus AHA) followed by second 6-month period (autonomy phase) in which the subjects of the study will continue with their ruled dietary patterns, but without any dietary or psychological support."
16239841|NCT01087086|Behavioral|American Heart Association|"After the recruitment and selection of the study participants, the study will consists of a 2-month nutritional intervention (Crononutrition versus AHA) followed by second 6-month period (autonomy phase) in which the subjects of the study will continue with their ruled dietary patterns, but without any dietary or psychological support."
16239842|NCT01087073|Behavioral|Patient Activation|Culturally tailored patient activation training classes providing education and communication strategies to empower patients to be proactive in their diabetes self-management behavior. Participants attend a 10 week interactive class. Diabetes support groups after the completion of these classes help patient maintain self-management and adherence to healthy behaviors.
16239843|NCT01087073|Behavioral|Provider Training|Provider patient-centered communication training focuses on cultural competency and communication skills training to aid in shared decision-making and tailoring treatment recommendations to the patient's cultural preferences and readiness. Providers attend 4 1-hour monthly modules and one booster workshop 3 months post-class.
16239844|NCT01087073|Behavioral|Quality Improvement|Participating clinics participate in quality improvement (QI) programs which aim to redesign clinic operations to improve care for diabetes patients. QI initiatives have included instituting group visits, patient medication cards, peer support groups, flow sheets, nurse case management, and patient registries. New initiatives include improving access and tracking of specialists visits, employing community health workers/patient navigators, coordinating care, and implementing other team-based care initiatives. Provider and clinical staff members from all six project clinics attend collaborative quarterly QI sessions with project staff to discuss improvements in QI efforts, share QI methods among clinic teams, and provide brief training sessions.
16239845|NCT01087073|Behavioral|Community Outreach|The project collaborates with many community based organizations and resources to reach out to communities at high risk for diabetes on the South Side of Chicago and facilitate diabetes education, particularly in the area of nutrition and physical activity. We provide monthly health education events, nutrition tours, and frequently participate in community-based health fairs and health promotion events. We also work to promote nutrition through the Food Rx program, which utilizes a prescription to link patients at our clinics with nutrition resources on the South Side of Chicago through a coupon that gives discounts towards healthy purchases at participating stores, and have initiated a 10-week fitness program to promote physical activity among minority patients with diabetes.
16239846|NCT01087060|Procedure|partial or radical nephrectomy|
16239847|NCT01087047|Device|Acoustic reflection method|An acoustic reflection device gives the longitudinal cross-sectional area profile along airways. It is based on the analysis of a planar acoustic wave propagating in a rigid duct connected to airway.
16239848|NCT01087034|Device|Acoustic reflection method evaluation|Evaluation of airways by acoustic relection method, with and without the bracing device
16239849|NCT01087034|Radiation|EOS™|Scoliosis and thoracic penetration index evaluation by EOS™ acquisition, with and without the bracing device
16239850|NCT01087034|Other|Non invasive respiratory muscle assessment|Non invasive respiratory muscles assessment, with and without the bracing device.
16239851|NCT01087021|Drug|Cabazitaxel (XRP6258)|"Pharmaceutical form:solution for infusion
~Route of administration: intravenous"
16239852|NCT01087008|Drug|zoledronic acid|Zoledronic acid 4 mg every 4 weeks for a total of 12 treatments
16239853|NCT01087008|Other|No treatment control|Patients doesn't receive treatment
16239854|NCT01086982|Drug|Octreotide acetate LAR|30 mg, single dose
16239855|NCT01086982|Drug|Sandostatin LAR ® (octreotide acetate LAR) 30 MG|30 mg, single dose
16239856|NCT01086969|Biological|Meningococcal Polysaccharide Diphtheria Toxoid Conjugate (Menactra®)|0.5 mL, Intramuscular
16239857|NCT01086956|Drug|epidural infusion of saline, ropivecaine, or ropivacaine and sufentanil|
16239858|NCT01086943|Device|LT2420|
16239859|NCT01086930|Device|ReJoyce Workstation|The device has two parts. A muscle-stimulator garment that incorporates a wireless-triggered stimulator cuff and an earpiece, similar to a hearing aid, that sends a radio signal to the stimulator cuff. As well as a specialised workstation known as ReJoyce, which connects to a standard computer via a USB port. This work station will allow the user to play specialised computer games focusing on hand function. The stimulator system and the ReJoyce workstation were developed by Professor Arthur Prochazka, University of Alberta, Canada and has been approved by the Canadian Standards Association.
16239860|NCT01086930|Other|Standard Care|All participants will continue to receive the same standard care for the hand and upper limb as typically provided by their rehabilitation units.
16239861|NCT01086917|Biological|PfSPZ Challenge|each volunteer to receive a single dose
16239862|NCT01086904|Biological|inactivated non adjuvanted pandemic H1N1 vaccine|two administrations at D and D21 (15 µg HA)
16239863|NCT01086891|Device|Oxygen conserving devices|Three 6MWT test will be performed at random with conventional oxygen continuous-flow,by Oxymizer Pendant and demand valve system. The percentage of patients correcting their desaturation and patients' acceptance of every method will be determinated.
16239864|NCT01086891|Device|Oxygen conserving devices|Three 6MWT test will be performed at random with conventional oxygen continuous-flow,by Oxymizer Pendant and demand valve system. The percentage of patients correcting their desaturation and patients' acceptance of every method will be determinated
16239865|NCT01086878|Drug|cotrimoxazole|"Daily oral cotrimoxazole suspension from 1 to 6 months of age at the following weight-based doses:
~less than 5kg: 100mg sulfamethoxazole, 20mg trimethoprim
~greater than 5kg: 200mg sulfamethoxazole, 40mg trimethoprim"
16239866|NCT01086865|Drug|Apetiviton BC|"Administer the recommended dosage preferably one hour before the main meal:
~Children (2 to 6 years): 2.5 mL 3 x daily. Adults (18 to 50 years): 5 mL 3 x daily. Elderly (60 to 80 years): 5 ml 3 x daily."
16239867|NCT01086852|Biological|FACTOR X|"Presurgery loading dose- The FX level of 70%-90% should be achieved.This will be calculated based on the patients weight on day of surgery and the required rise. Initial dose should not exceed 60IU/kg.
~Post surgery- FX trough levels of 50% should be achieved.
~Intravenous infusion of factor X is given at a suggested rate of 10mL/min but not exceeding more than 20mL/min."
16239868|NCT01086839|Drug|sodium chloride 6%|"one ampoule sodium chloride 6% per day
~inhalation use
~for 28 days"
16239869|NCT01086839|Drug|sodium chloride 0,9%|"one ampoule sodium chloride 0,9% per day
~inhalation use
~for 28 days"
16239870|NCT01086826|Drug|RT+CDDP/5-FU|RT=70 Gy (2 Gy x1/day, 5 days per week for 7 weeks) CDDP: 20 mg/m2/day as 30 minutes IV infusion from day 1 to day 4 5-FU: 800 mg/m2/day for 4 days Both drugs will be administered during weeks 1 and 6 of irradiation, starting from day 1 of radiotherapy.
16239871|NCT01086826|Drug|RT+CETUXIMAB|RT= 70 Gy (2 Gy x1/day, 5 days per week for 7 weeks) Cetuximab= 400 mg/m2 as first dose.Subsequent doses of 250 mg/ m2, weekly, for 7 times.
16239872|NCT01086826|Drug|INDUCTION CTx(TPF)+(RT+CDDP/5-FU)|"INDUCTION CTx(TPF):docetaxel 75 mg/m² + CDDP 80mg/m² + 5-FU 800 mg/m²/day from day 1 to day 4 will begin after the end of cisplatin infusion on day 1.Every 3 weeks.
~concomitant CTx= CDDP 20 mg/m2/day + 5-FU 800 mg/m2/day RT= 70 Gy(2 Gy x1/day, 5 days per week for 7 weeks)"
16239873|NCT01086826|Drug|INDUCTION CTx(TPF)+(RT+CETUXIMAB)|"INDUCTION CTx(TPF):docetaxel 75 mg/m² + CDDP 80mg/m² + 5-FU 800 mg/m²/day from day 1 to day 4 will begin after the end of cisplatin infusion on day 1.Every 3 weeks.
~RT= 70 Gy(2 Gy x1/day, 5 days per week for 7 weeks) CETUXIMAB= 400 mg/m2 as first dose. Subsequent doses of 250 mg/ m2, weekly, for 7 times."
16239874|NCT01086813|Drug|AZD3043|single dose/IV, bolus over 60secs - infusion over 30 mins
16239875|NCT01086800|Other|Healthy Lifestyles and Sleep Education plus PAP|Participants randomized to this arm will be educated on PAP and then use PAP for 3 months. They will also receive optimized medical preventive therapy according to current American Heart Association guidelines for prevention of CVD and sleep guidelines.
16239876|NCT01086800|Other|Healthy Lifestyles and Sleep Education plus Supplemental Oxygen|Participants randomized to this arm will be educated on nocturnal supplemental oxygen and then use oxygen for 3 months. They also will receive optimized medical preventive therapy according to current American Heart Association guidelines for prevention of CVD and sleep guidelines.
16239877|NCT01086800|Other|Healthy Lifestyles and Sleep Education|Participants randomized to this arm will receive optimized medical preventive therapy according to current American Heart Association guidelines for prevention of CVD and sleep guidelines.
16239878|NCT01086787|Other|Surgery|Patients undergoing surgery for either cardiac surgery or orthopedic surgery
16239879|NCT01086774|Other|Systane Ultra Lubricant Eye Drops|Single drop in both eyes
16239880|NCT01086761|Biological|MP0112|Single intravitreal injection of MP0112 in the study eye.
16239881|NCT01086748|Drug|Risperidone|Administered orally.
16239882|NCT01086748|Drug|Placebo|Administered orally.
16239883|NCT01086748|Drug|LY2140023|Administered orally.
16239884|NCT01086735|Biological|donor lymphocyte infusion|Donor T-cell transduction
16239885|NCT01086722|Drug|"karolinska cocktail"|"The karolinska cocktail contains dextrometorphan, caffeine, losartan and omeprazol"
16239886|NCT01086696|Drug|FPAC|Each subject will be administered 7 mCi of FPAC,over 10-20 seconds, followed by saline flush.
16239887|NCT01086683|Behavioral|Psychosocial rehabilitation course|Groups of 20 cancer survivors participated in a 6-day multi-focused, psychosocial intervention at the Dallund rehabilitation centre. The overall aim was to strengthen each individual's physical, psychological and social functioning. Sharing experiences with other cancer patients and experiencing peer-support was a central issue. The retreat combined lectures, discussions and patient group work on themes such as the treatment of cancer, psychological reactions, spirituality, sexuality and lifestyle. Participants were involved in physical activities, and the daily menu represented a healthy diet. The course was conducted by a multi-disciplinary team. Each participant produced a personal, specific 'action plan', which was intended to serve as a 'booster' after returning to daily life.
16239889|NCT01086657|Biological|VRC-AVIDNA036-00-VP|H5 DNA Vaccine
16239890|NCT01086657|Biological|Monovalent Influenza Subunit Virion (Inactive H5N1) Vaccine|Inactive H5N1 Vaccine
16239891|NCT01086631|Drug|Rituximab|
16239892|NCT01086618|Drug|systemic chemotherapy|
16239893|NCT01086618|Procedure|adjuvant therapy|
16239894|NCT01086618|Procedure|quality-of-life assessment|
16239895|NCT01086618|Procedure|therapeutic conventional surgery|
16239896|NCT01086605|Drug|pixantrone dimaleate|Given IV
16239898|NCT01086592|Other|Strong progressive strengthening exercises of lower limbs|Lower limb weight
16239899|NCT01086592|Other|Electrotherapy|Neuromuscular Electrical Nerve Stimulation
16239900|NCT01086592|Other|Electrotherapy+weights|Superimposed Neuromuscular Electric Nerve Stimulation
16239901|NCT01086579|Device|IN.PACT Falcon paclitaxel eluting balloon (Drug eluting balloon)|Coronary Artery Bypass Graft (CABG)
16239902|NCT01086579|Device|Taxus (Paclitaxel eluting stent)|Percutaneous transluminal coronary angioplasty (PTCA) with stent
16239903|NCT01086566|Biological|Influenza Virus Vaccine, Monovalent A/H5N1 A/Indonesia/05/2005|Inactivated monovalent subvirion H5N1 vaccine (HA of A/Indonesia/05/05) provided in unit-dose vials containing 0.5 mL of either 30 mcg/mL A/H5N1 HA or 180 mcg/mL A/H5N1 HA. Subjects will receive 1 of 2 dose levels of vaccine, 15 or 90 mcg.
16239904|NCT01086553|Drug|budesonide|9mg budesonide OD
16239905|NCT01086553|Drug|budesonide|3mg budesonide TID
16239906|NCT01086540|Biological|Rituximab|"Participants receive rituximab intravenous (IV) infusions, 1000 mg each, 14 days apart (Day 0 and Week 2).
~Rituximab is supplied as a sterile, clear, colorless, preservative-free liquid concentrate for intravenous (IV) administration in either 100 mg (10 mL) or 500 mg (50 mL) single-use vials, which must be diluted before administration
~Standard rituximab pre-medications will be provided in preparation for the rituximab infusions."
16239907|NCT01086540|Other|Placebo|"Participants receive placebo intravenous (IV) infusions 14 days apart (Day 0 and Week 2).
~Standard pre-medications will be provided in preparation for the infusions."
16239908|NCT01086540|Diagnostic Test|CMRI|Up to 20 participants from each treatment arm will be assessed by CMRI at Baseline and at Week 24.
16239909|NCT01086540|Drug|prednisone|Prednisone dose of 40 mg (or equivalent) by mouth administered the night before and the morning of each study drug infusion.
16239910|NCT01086540|Drug|methylprednisolone|Methylprednisolone (or equivalent corticosteroid) administered intravenously 30 minutes prior to each study drug infusion.
16239911|NCT01086540|Drug|diphenhydramine|"Diphenhydramine 50 mg (or equivalent) administered by mouth approximately thirty to sixty minutes prior to each study drug infusion.
~Dose may be repeated every four hours, as needed."
16239912|NCT01086540|Drug|acetaminophen|"Acetaminophen 650 mg (or equivalent) administered by mouth approximately thirty to sixty minutes prior to each study drug infusion.
~Dose may be repeated every four hours, as needed."
16239913|NCT01086527|Drug|10 mg tablet of montelukast (Singulair)|Fasting patients will take a single 10 mg tablet of montelukast with 240 ml of Gatorade. Eight blood samples will be drawn to assess the plasma concentration of montelukast over the subsequent 12 hours.
16239914|NCT01086514|Procedure|Dual Energy Contrast Enhanced Digital Mammography (DE CEDM)|Each patient will have: Bilateral digital mammography, Bilateral Breast MRI, Bilateral Contrast Enhanced Digital Mammography. The latter examination is the only change in patient management. An additional contrast injection is involved. Results of the DE CEDM will be compared with routine digital mammography and breast MRI. The reference standard is pathology. If surgery is to be done; every attempt will be made to perform all imaging exams within 30 days.
16239915|NCT01086488|Drug|FOSCAN|Patients will be randomised to one of two treatment groups. The first group of 26 patients will receive 0.1 mg/kg Foscan® at a drug-light interval of 48 hours (2 days). A single surface illumination light dose of 20 J/cm2 fluence rate of 50 mW at 652 nm will be used. The second reference group of 26 patients will be treated by intracavitary brachytherapy
16239916|NCT01086475|Drug|D-cycloserine|50 mg dose administered 30 minutes prior to each of the ten Social Skill Training Sessions
16239917|NCT01086475|Drug|Placebo|Placebo pill administered 30 minutes prior to each of the ten Social Skill Training Sessions
16239918|NCT01086462|Drug|GSK2239633|100 ug GSK2239633 containing approximately 10kBq [14C]-GSK2239633
16239919|NCT01086449|Biological|Herpes Zoster Vaccine GSK 1437173A|Investigational vaccine (GSK 1437173A) administered intramuscularly.
16239920|NCT01086436|Biological|Rotarix ™|Oral, single dose
16239921|NCT01086436|Biological|Placebo|Oral, single dose
16239922|NCT01086423|Biological|Infanrix-IPV/Hib™|Intramuscular, three doses
16239923|NCT01086423|Biological|Infanrix Hib™|Intramuscular, three doses
16239924|NCT01086423|Biological|Poliorix™|Intramuscular, three doses
16239925|NCT01086410|Drug|Placebo Inhalation Powder|Placebo Inhalation powder inhaled once daily for 6 weeks' treatment
16239926|NCT01086410|Drug|Fluticasone Furoate/GW642444 Inhalation Powder|Dose B inhaled once daily for 6 weeks' treatment
16239927|NCT01086410|Drug|Fluticasone Furoate/GW642444 Inhalation Powder|Dose A inhaled once daily for 6 weeks' treatment
16239928|NCT01086410|Drug|Placebo Oral Capsule|One placebo capsule taken each day on the last 7 days of the study
16239929|NCT01086410|Drug|Prednisolone Oral Capsule|Prednisolone 10mg oral capsule taken each day on the last 7 days of the study
16239930|NCT01086397|Procedure|Urine sample collection|All subjects have non-invasive urine sample collection performed
16239931|NCT01086384|Drug|Fluticasone Furoate/GW642444|Combination inhaled corticosteroid and long-acting beta2-agonist
16239932|NCT01086384|Drug|Fluticasone furoate|Inhaled corticosteroid
16239933|NCT01086371|Other|Rhythmic auditory stimulation|Recorded music with embedded beat set 10% above the subject's baseline walking cadence.
16239934|NCT01086371|Other|Walking exercise|Subjects will be walking daily for a total of 20 minutes (may be broken down to smaller time periods.
16239935|NCT01086358|Drug|Triptan|Usual prescribed triptans may include:sumatriptan, rizatriptan, naratriptan, almotriptan, eletriptan, zolmitriptan
16239936|NCT01086358|Drug|Treximet 85Mg-500Mg Tablet|Treximet is 85 mg sumatriptan plus 500 mg naproxen sodium
16239937|NCT01086345|Radiation|radiosurgery|Patients undergo radiosurgery 10-14 days after beginning bevacizumab.
16239938|NCT01086345|Biological|bevacizumab|Given IV
16239939|NCT01086345|Drug|irinotecan hydrochloride|Given IV
16239940|NCT01086332|Drug|Nelfinavir|1250 mg twice daily
16239941|NCT01086332|Drug|Gemcitabine|Escalating doses of gemcitabine during concurrent radiation and nelfinavir therapy.
16239942|NCT01086267|Drug|BMS-908662|Capsules, Oral, escalating doses starting at 25 mg, every 12 hours (Q 12 h), Continuously
16239943|NCT01086267|Drug|BMS-908662|Capsules, Oral, (TBD) mg, Q 12 h, Continuously
16239944|NCT01086267|Drug|Cetuximab|Vial, IV, 400 mg/m² loading dose followed by 250 mg/m² maintenance dose, Weekly, Continuously
16239945|NCT01086254|Drug|Iniparib|"Pharmaceutical form: solution for infusion
~Route of administration: 60-minute IV infusion"
16239946|NCT01086254|Drug|gemcitabine|"Pharmaceutical form: solution for infusion
~Route of administration: 30-minute IV infusion"
16239947|NCT01086254|Drug|cisplatin|"Pharmaceutical form: solution for infusion
~Route of administration: 1- to 4-hour IV infusion, according to the local standard"
16239948|NCT01086241|Procedure|2D Mammogram|Those patients randomized to the mammogram arm will receive a regular 2D mammogram. Compression lasts several seconds in order to obtain 4 views. The x-ray tube is programmed to obtain an arc of low dose projection images through the breast.
16239949|NCT01086241|Procedure|Tomosynthesis|Those patients randomized to the tomosynthesis arm will receive a combination of 3D and 2D screening mammogram. The additional tomosynthesis data is obtained immediately after acquisition of the 2D study, with the patient and breast remaining in the same position and compression. Compression lasts about 7 seconds longer for each of the 4 views. The x-ray tube is programmed to obtain an arc of low dose projection images through the breast.
16239950|NCT01086228|Device|XIENCE V / PROMUS stent|Patients receiving XIENCE V stent(s) or PROMUS stent(s) during their index procedure.
16239951|NCT01086176|Device|NMT (a device that can do neurostimulation and can record the response on the stimulation by Datex)|on one side, we do a post-tetanic count, on the other side we don't, after, we do train-of-four on both sides and check the difference
16239952|NCT01086163|Drug|Omacor, omega-3 fatty acids in CAD patients|Omacor 1g versus 2g daily versus placebo
16239953|NCT01086150|Procedure|Skin biopsy|Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes.
16239954|NCT01086150|Drug|Lidocaine 5% patches|Subject will apply patches to affected area QD for 12 hours then remove.
16239955|NCT01086085|Drug|Adefovir|Adefovir 10 mg po once daily for 36 weeks
16239956|NCT01086085|Drug|peginterferon alfa-2a [PEGASYS]|Early responders: PEGASYS 180 mcg sc once weekly for 48 weeks
16239957|NCT01086085|Drug|peginterferon alfa-2a [PEGASYS]|Non-early responders: PEGASYS 180 mcg sc once weekly for 48 weeks
16239958|NCT01086085|Drug|peginterferon alfa-2a [PEGASYS]|Non-early responders: PEGASYS 180 mcg sc once weekly for 96 weeks
16239959|NCT01086046|Drug|Low molecular weight heparin|"Low molecular weight heparin sodium injection 1mg/kg 2 times in 24 hour
~Low molecular weight heparin sodium injection 1mg/kg 2 times per day in 3 days."
16239960|NCT01086020|Drug|atorvastatin|Patients admitted with 20-70% coronary artery plaque identified by angiography will be treated with atorvastatin 10mg/d for two years
16239961|NCT01086020|Drug|atorvastatin plus ezetimibe|Patients admitted with 20-70% coronary artery plaque identified by angiography will be treated with atorvastatin 5mg/d and Ezetimibe 5mg/d for two years
16239962|NCT01085994|Other|Literature search|Literature search followed by systematic review and meta-analysis
16239963|NCT01085981|Drug|arginine 20%, nicotinamide .01%, niacin.1%, in LipodermPG 50%|On the first office visit the patient will have their baseline clitoral and uterine blood flow measured quantitatively by the same sonographer using the General electric Voluson 700 unit. Clitoral blood flow will be accessed utilizing the 12 megahertz linear probe. With light pressure, the probe will be applied sagittally and proximal to the clitoral hood with an angle less than 20 degrees. Peak clitoral artery systolic and end diastolic velocity will be measured and resistive index values will be recorded. Then utilizing the 7.5 megahertz vaginal probe baseline uterine artery flow measurements will also be obtained and recorded. With both GRAS cream and placebo.
16239964|NCT01085981|Drug|Topical study cream|One gram applied to clitoris by nurse then ten minutes later doppler study of clitoral blood flow
16239965|NCT01085981|Drug|GRAS cream|1 gram of active cream will be applied by nurse then 10 minutes later clitoral blood flow will be assessed by doppler studies see protocol
16239966|NCT01085968|Behavioral|PC based training|Subjects sit at a computer and type a string of numbers that appears on the screen. As performance improves (# correct), the strings of numbers get longer. They are then instructed to repeat the string from memory. Performing these key entries from memory is a test of internally generated movement initiation.
16239967|NCT01085929|Procedure|Incision and Drainage|Surgical incision of the skin surface followed by expression of purulence with or without debridement or manual exploration of abscess cavity.
16239968|NCT01085929|Procedure|Ultrasound Guided Aspiration|Ultrasound is used to identify the abscess cavity. An 18 gauge needle is introduced into the abscess cavity and manual aspiration of the abscess contents is attempted.
16239969|NCT01085903|Drug|Modafinil|200 mg once daily with morning meal for three days administered only to stroke patients
16239970|NCT01085903|Drug|Placebo|Subjects will receive a placebo designed to look like 200 mg dose of modafinil. The dose will be taken once daily with the morning meal for three days and will only be administered to stroke patients
16239971|NCT01085903|Behavioral|Baseline|Observations made at baseline before any intervention
16239972|NCT01085903|Behavioral|CPS|Submerging each participant's foot into ice water (36-44 F) for 50 seconds.
16239973|NCT01085903|Behavioral|Post CPS|20 minutes following the CPS condition.
16239974|NCT01085903|Behavioral|Follow up|Follow up testing occurred at 3 months
16239975|NCT01085890|Behavioral|Motivational interviewing|The intervention consisted of 2 group seminars with information on hypertension and related lifestyle factors and 2 follow-up visits in which blood pressure was measured and motivational interviewing took place. The motivational interviewing focused on lifestyle factors, including physical activity, stress, tobacco use, alcohol habits, and diet.
16239976|NCT01085877|Drug|estradiol, 25 mcg|Single dose of vaginal tablet containing 25 mcg estradiol (Production site A) followed by another single dose of vaginal tablet containing 25 mcg estradiol (Production site B)
16239977|NCT01085877|Drug|estradiol, 25 mcg|Single dose of vaginal tablet containing 25 mcg estradiol (Production site B) followed by another single dose of vaginal tablet containing 25 mcg estradiol (Production site A)
16239978|NCT01085851|Drug|Dexchlorpheniramine 1% lotion|Small amount applied over the lesion twice a day for 7 days
16239979|NCT01085851|Drug|Dexchlorpheniramine 1% cream|Small amount applied over the lesion twice a day for 7 days
16239980|NCT01085838|Drug|Erlotinib|Erlotinib oral capsule, 100, 150, or 300 mg/day during 12 weeks at study start
16240191|NCT01084265|Drug|Recombinant human luteinizing hormone (r-hLH)|One r-hLH (75 International Units [IU]) injection s.c. once daily.
16239981|NCT01085825|Procedure|D & C abortion|Participants will be randomized to receive their abortion using either manual vacuum aspiration or electric vacuum aspiration.
16239982|NCT01085812|Drug|Levomilnacipran ER|Drug: Levomilnacipran ER (40, 80 or 120 mg/day) Study drug is to be given orally, in capsule form, once daily.
16239983|NCT01085812|Drug|Placebo|Matching placebo to be given orally, in capsule form, once daily.
16239984|NCT01085799|Behavioral|Health Education Intervention|This is a health hygiene education strategy which encourages the pro-active role of both teachers and students and changes in attitudes and practices with the aim of keeping the level of parasite infection low, through increased knowledge.
16239985|NCT01085786|Drug|14-day sequential treatment|"14-day sequential therapy arm: esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
~14-day hybrid therapy arm: esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days"
16239986|NCT01085786|Drug|14-day hybrid treatment|esomeprazole 40 mg and amoxicillin 1 g twice daily for 7 days followed by esomeprazole 40 mg, amoxicillin 1 g, clarithromycin 500 mg and metronidazole 500 mg twice daily for 7 days
16239987|NCT01085773|Behavioral|Exercise on Prescription|The physical training consisted of both aerobic and strength training and took place in supervised groups.
16239988|NCT01085773|Behavioral|Nordic Walking|Nordic Walking is a fitness type of walking; incorporating the use of specially designed walking sticks. Nordic Walking focuses on aerobic training where the additional activity of the arms increases a person's oxygen uptake and energy expenditure.
16239989|NCT01085760|Drug|Vancomycin|Comparison of different doses of drug
16239990|NCT01085760|Drug|Vancomycin|Comparison of different doses of drug
16239991|NCT01085760|Drug|Metronidazole|Comparison of different doses of drug
16239992|NCT01085760|Drug|Metronidazole|Comparison of different doses of drug
16239993|NCT01085760|Drug|Vancomycin|Comparison of different drug doses
16239994|NCT01085734|Drug|Avastin|1.25mg intravitreally
16239995|NCT01085734|Drug|Osurdex|0.7mg intravitreally
16239996|NCT01085734|Drug|Avastin|1.25mg intravitreally
16239997|NCT01085721|Drug|Dexchlorpheniramine, pseudoephedrine, guaifenesin|5 mL (2 mg dexchlorpheniramine, 20 mg pseudoephedrine and 100 mg guaifenesin) qid for 5 days
16239998|NCT01085721|Drug|Dexchlorpheniramine|5 mL (2 mg dexchlorpheniramine) qid for 5 days
16239999|NCT01085708|Drug|rabeprazole|10 mg normal tablet
16240000|NCT01085708|Drug|rabeprazole|Type 1 granule containing rabeprazole 10 mg
16240001|NCT01085708|Drug|rabeprazole|Type 2 granules containing rabeprazole 10 mg
16240002|NCT01085708|Drug|rabeprazole|Type 3 granules containing rabeprazole 10 mg
16240003|NCT01085695|Drug|rabeprazole|10 mg normal tablet
16240004|NCT01085695|Drug|rabeprazole|Type 1 granule containing rabeprazole 10 mg
16240005|NCT01085695|Drug|rabeprazole|Type 2 granule containing rabeprazole 10 mg
16240006|NCT01085695|Drug|rabeprazole|Type 3 granule containing rabeprazole 10 mg
16240007|NCT01085682|Behavioral|Lifestyle counseling|In intervention group, counseling sessions are conducted weekly for 3 months, once per two weeks for 3 months, monthly for 18 months, and then once every two months for the remainder of the study.
16240008|NCT01085682|Behavioral|Standard care|In standard care group, counseling sessions are conducted only 6 times for 4 years
16240009|NCT01085669|Device|Microbiological analysis of retained VEPTR Implants|Implants have to be adapted every half a year, the retained implants during revision are analysed for biological colonization.
16240010|NCT01085656|Drug|OXi4503|"Two safety cohorts treating two (2) patients at a dose of 2.5 mg/m2 followed by two patients at 3.75 mg/m2 will be completed prior to beginning at the dose level of 5 mg/m2.
~Dosing of OXi4503 will be an intravenous infusion (IV) over 10 minutes on Days 1, 8, 15, and 22 of each 28 day cycle.
~Dose escalations and de-escalations of 25% will be made until the maximum tolerated dose is reached.
~Number of cycles: After Cycle 1, subjects who achieve stable disease (SD) or greater response may continue to receive additional cycles of treatment until either disease progression (defined as greater than 25% increase in leukemia myeloblasts in the bone marrow compared to baseline examination) or unacceptable toxicity due to the investigational agent."
16240011|NCT01085643|Drug|Lubiprostone|24mcg PO taken once
16240012|NCT01085643|Drug|Placebo|24mcg placebo capsule taken once
16240013|NCT01085630|Drug|pemetrexed disodium|Given IV
16240014|NCT01085630|Other|clinical observation|
16240015|NCT01085617|Biological|palifermin|
16240016|NCT01085617|Biological|rituximab|
16240017|NCT01085617|Drug|cyclophosphamide|
16240018|NCT01085617|Drug|cytarabine|
16240019|NCT01085617|Drug|daunorubicin hydrochloride|
16240020|NCT01085617|Drug|etoposide|
16240021|NCT01085617|Drug|fludarabine phosphate|
16240022|NCT01085617|Drug|imatinib mesylate|
16240023|NCT01085617|Drug|melphalan|
16240024|NCT01085617|Drug|mercaptopurine|
16240025|NCT01085617|Drug|methotrexate|
16240026|NCT01085617|Drug|nelarabine|
16240027|NCT01085617|Drug|pegaspargase|
16240028|NCT01085617|Drug|vincristine sulfate|
16240029|NCT01085617|Procedure|allogeneic hematopoietic stem cell transplantation|
16240030|NCT01085617|Radiation|total-body irradiation|
16240031|NCT01085604|Other|Core Stabilization|"The 8-week core stabilization program emphasizes use of specific local stabilizing muscles (transverse abdominis[TrA], lumbar multifidus[LM]) to restore active control and stability to the trunk. This program emphasizes training using isometric co-contractions and a progression (3 stages) based upon a motor learning paradigm.
~Stage 1: emphasizes neutral position of the spine and activation of the TrA and LM. Performance feedback is emphasized and monitored through observation and palpation.
~Stage 2: promotes maintenance the co-contraction while performing movements of the trunk and superimposing movements of the upper and lower extremities. Trunk conditioning is also emphasized (i.e., curl ups, quadruped leg/arm lifts and side support). Feedback is gradually reduced.
~Stage 3: emphasis on maintenance of the co-contraction while performing exercises on an unstable surface or during perturbation of the activity. Random practice patterns are used to enhance motor learning."
16240032|NCT01085591|Drug|CB-183,315|
16240033|NCT01085591|Drug|Placebo|
16240035|NCT01085578|Drug|CG400549/placebo|Period 1: a single oral dose of 80 mg CG400549 or placebo on Day 1 Period 2: a single oral dose of 320 mg CG400549 or placebo on Day 1 Period 3: a single oral dose of 1280 mg CG400549 or placebo on Day 1
16240036|NCT01085578|Drug|CG400549/placebo|Period 1: a single oral dose of 160 mg CG400549 or placebo on Day 1 Period 2: a single oral dose of 640 mg CG400549 or placebo on Day 1 Period 3: a single oral dose of 1920 mg CG400549 or placebo on Day 1
16240037|NCT01085578|Drug|CG400549|Period 1: a single oral dose of 640 mg CG400549 on Day 1 in the fasted state Period 2: a single oral dose of 640 mg CG400549 on Day 1 in the fed state
16240038|NCT01085565|Device|ExAblate 2100|Conformal Bone System
16240039|NCT01085552|Drug|Epoetin Beta|Epoetin Beta. A single subcutaneous dose of 50IU/kg on Day 1. The body weight recording on day -1 will be used to calculate the dosage
16240040|NCT01085526|Biological|Alutard phleum pratense subcutaneous immunotherapy|standard regimen of SCIT
16240041|NCT01085526|Drug|Alutard phl prat|
16240042|NCT01085513|Device|PillCam SB2|The disposable, ingestible PillCam SB 2 Capsule, part no. FGS-0180, is designed to acquire video images during natural propulsion through the small bowel. The capsule transmits acquired images via RF communication channel to the DataRecorder located outside the body.
16240043|NCT01085500|Behavioral|Mastery Learning TEP Curriculum|A simulation-based educational curriculum
16240044|NCT01085500|Procedure|Current Practice|The current practice of learning how to perform the TEP repair in the operating room is under direct supervision of the staff surgeon without any simulation pre-training.
16240045|NCT01085487|Drug|Levonorgestrel (Mirena, BAY86-5028)|Women using Mirena for treatment of menorrhagia
16240046|NCT01085487|Drug|Hormonal treatment|Hormonal treatment (including combined oral contraceptives or oral or injectable progestogens)
16240047|NCT01085487|Drug|Antifibrinolytic treatment|Antifibrinolytic treatment (such as tranexamic acid)
16240048|NCT01085474|Other|1|In the pilot study the objective is to compare 2 different pharmaceutical interventions (A and B) and to assess which one improves disease control, patient adherence and patient knowledge of the medication.
16240049|NCT01085474|Other|2|The best intervention used in the pilot study will be chosen and included in the main study.
16240050|NCT01085448|Other|Core Stabilization|"The 8-week program emphasizes use of specific local stabilizing muscles (transverse abdominis[TrA], lumbar multifidus[LM]) to restore active control to the trunk. Emphasis is on training isometric co-contractions and a progression (3 stages) based upon a motor learning paradigm.
~Stage 1: neutral position of the spine and activation of the TrA and LM. Performance feedback is emphasized and monitored through observation and palpation.
~Stage 2: maintenance the co-contraction while performing movements of the trunk and the upper and lower extremities. Trunk conditioning is also emphasized. Feedback is gradually reduced.
~Stage 3: maintenance of the co-contraction while performing exercises on an unstable surface or during perturbation of the activity. Random practice patterns are used to enhance motor learning."
16240051|NCT01085435|Device|S-ICD System|The S-ICD System is an implantable technology that uses a subcutaneous pulse generator and subcutaneous electrode system to treat ventricular tachyarrhythmias. The S-ICD System consists of the pulse generator, subcutaneous electrode, the programmer and electrode insertion tool.
16240052|NCT01085422|Drug|ABT-888|Subjects will be given ABT-888 on Days 1 -7 every 28 days orally and temozolomide on days 1-5 on days 1-5 every 28 days orally with ABT-888
16240053|NCT01085422|Drug|temozolomide|Subjects will be given ABT-888 40 mg twice daily on Days 1 -7 every 28 days orally and temozolomide on days 1-5 every 28 days orally with ABT-888
16240054|NCT01085383|Drug|Aripiprazole|Aripiprazole will be started at 5 mg daily and increased in a treat-to-target fashion by 5 mg steps until the primary outcome or the maximum tolerated or permitted dose of 30 mg is reached
16240055|NCT01085370|Other|Early psychological intervention|3 modules: psychoeducation, reconstruction of the trauma, coping skills
16240056|NCT01085357|Procedure|Cataract Surgery|Cataract Surgery involves the removal of the natural lens, which has become clouded (called a cataract), and insertion of an artificial lens (called an intraocular lens). This procedure is done through a small surgical incision in the eye.
16240057|NCT01085357|Device|CyPass Micro-Stent|The CyPass Micro-Stent is a small tube with a through-lumen designed to redirect aqueous fluid from the front to the back of the eye. The CyPass is implanted in the eye after completion of cataract surgery.
16240058|NCT01085344|Biological|Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS)|escalating dose prophylaxis
16240059|NCT01085344|Biological|Recombinant Factor VIII (Advate/Helixate FS/KoegenateFS)|escalating dose
16240060|NCT01085331|Drug|Pimasertib|Subjects will be administered with pimasertib orally once daily on Days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle.
16240061|NCT01085331|Drug|Placebo|Subjects will be administered with placebo orally once daily on days 1-5, 8-12, 15-19, and 22-26 of a 28 day cycle.
16240062|NCT01085331|Drug|FOLFIRI|Subjects will be administered with FOLFIRI (laevoleucovorin 200 milligram per square meter [mg/m^2] intravenous [i.v] infusion over 90 minutes or leucovorin [dl-leucovorin] 400 mg/m^2 i.v. infusion over 90 minutes; followed by irinotecan 180 mg/m^2 given as a 90-minute infusion in 500 milliliter [mL] dextrose 5%; followed by a bolus 5-fluorouracil [FU] 400 mg/m^2 and a 46-hour infusion 5-FU 2400 mg/m^2) at conventional doses on days 1 and 15 of the same 28 day cycle.
16240063|NCT01085318|Drug|Rebif|44 mcg tiw
16240064|NCT01085305|Behavioral|Parent-Child Interaction Therapy|Parents will be trained in interaction with their children in ways which foster non-hostility and cooperation in their children. By means of an ear-plug they will receive instruction on how to play and set limits for their child from their therapist who watches the interaction through a one-way mirror. Treatment is given until the parent masters these skill, which commonly takes 15-20 session of 1 hour.
16240065|NCT01085305|Behavioral|TAU|Usual treatment for behavioral disorders
16240066|NCT01085292|Drug|NOX-E36|Multiple dose 0.25 mg/kg or placebo i.v. to healthy volunteers; dosing frequency q2d
16240067|NCT01085292|Drug|NOX-E36|Multiple dose of 0.0625 mg/kg, 0.125 mg/kg, 0.25 mg/kg or placebo i.v. to patients with type 2 diabetes mellitus (ratio 3:1); dosing frequency q2d
16240068|NCT01085279|Device|Fraxel Restore, Solta Medical Inc. (Non-ablative fractional laser)|1,550 nm non-ablative fractional laser Irradiance: 15 mJ/microbeam. Coverage: 14-20%. Number of treatment sessions: 4-5
16240192|NCT01084265|Drug|Recombinant human follicle-stimulating hormone (r-hFSH)|One r-hFSH (150 IU) injection s.c. once daily.
16240069|NCT01085279|Drug|Modified Kligman's formula (Triple topical therapy)|Hydroquinone 5%, tretinoin 0.05%, triamcinolone acetonide 0.1% once a day during 15 weeks
16240070|NCT01085266|Drug|Dimebon (latrepirdine)|
16240071|NCT01085253|Other|3T and 7T MR imaging|all patients and controls will be explored using a 3T and 7T MR imaging
16240072|NCT01085240|Other|Mission Possible|The intervention focuses on leisure education, exercise and community re-integration.
16240073|NCT01085214|Other|Laboratory Biomarker Analysis|Correlative studies
16240074|NCT01085214|Drug|Selumetinib|AZD6244 (Selumetinib), 75 mg was administered orally, twice a day, continuously for 28-day cycles
16240075|NCT01085201|Drug|Lexiscan|Given as an infusion
16240076|NCT01085188|Behavioral|ACC|Weekly community based behavioral counseling and case management
16240077|NCT01085188|Behavioral|CM|Weekly community based prize drawing opportunities contingent upon completed verifiable pro-social activities and clean urine and breath alcohol test results
16240078|NCT01085188|Behavioral|UCC|recommendation made by discharge counselor upon leaving residential treatment to attend nearest outpatient clinic.
16240079|NCT01085175|Drug|LMI 1195|Single bolus intravenous injection of LMI 1195
16240080|NCT01085162|Drug|BMS747158|BMS747158 is a novel PET MPI agent labeled with Fluorine-18.
16240081|NCT01085149|Drug|Simvastatin|10 mg simvastatin, slow release in socket of extracted tooth (single application only)
16240082|NCT01085136|Drug|Investigator´s choice of chemotherapy|BIBW 2992 in a medium dose in combination with Paclitaxel to explore safety and efficacy versus investigator´s choice of chemotherapy
16240083|NCT01085136|Drug|BIBW 2992|BIBW 2992 will be given in a medium dose in combination with Paclitaxel to explore safety and efficacy versus investigator´s choice of chemotherapy
16240084|NCT01085123|Drug|Rapimelt|oral tablet , 2.5 and 5 mg, single dose. 10 mg (2x5 mg) visit 3, 5 mg visit 4, 2.5 mg visit 5.
16240085|NCT01085123|Drug|[11C]AZ10419369|solution for iv injection. Will be injected within 2 to 5 hours after administration of ZOMIG® Rapimelt
16240086|NCT01085097|Drug|laquinimod|Laquinimod 0.5 mg or 1 mg
16240087|NCT01085097|Drug|Mycophenolate Mofetil|Mycophenolate Mofetil (MMF)
16240088|NCT01085097|Drug|prednisolone/prednisone|corticosteroids
16240089|NCT01085097|Drug|Placebo|Placebo
16240090|NCT01085084|Drug|Laquinimod|Laquinimod 0.5 mg once daily for 12 weeks
16240091|NCT01085084|Drug|Laquinimod|Laquinimod 1 mg oral once daily for 12 weeks
16240092|NCT01085084|Other|Placebo|Placebo oral once daily for 12 weeks
16240093|NCT01085071|Drug|Potassium Chloride|KCl is continuously administered and titrated towards a Normal-high Potassium (4.5 mmol/L)
16240094|NCT01085071|Drug|Potassium Chloride|KCl is continuously administered and titrated towards a Normal-low Potassium (4.0 mmol/L)
16240095|NCT01085058|Drug|lenograstim|
16240096|NCT01085045|Drug|PT003 MDI|Inhaled PT003 MDI administered as two puffs BID for 7 days
16240097|NCT01085045|Drug|PT005 MDI|Inhaled PT005 MDI administered as two puffs BID for 7 days
16240098|NCT01085045|Drug|Placebo MDI|Inhaled placebo administered as two puffs BID for 7 days
16240099|NCT01085045|Drug|Tiotropium bromide 18 μg (Spiriva Handihaler®)|Inhaled tiotropium bromide 18 μg (Spiriva Handihaler®) administered QD for 7 days
16240100|NCT01085045|Drug|Formoterol Fumarate 12 μg (Foradil® Aerolizer®)|Inhaled formoterol fumarate 12 μg (Foradil® Aerolizer®) administered BID for 7 days
16240101|NCT01085045|Drug|PT001 MDI|Inhaled PT001 MDI administered as two puffs BID for 7 days
16240102|NCT01085032|Drug|Transdermal Nicotine|Subjects in the experimental group receive six weeks of nicotine patch treatment, 24 hour dose, using a step-down algorithm. Participants who smoke greater than 10 cigarettes/day receive two weeks of 21 mg patch, followed by two weeks of 14 mg patch, and then two weeks of 7 mg patch. Participants who smoke 5-9 cigarettes per day receive four weeks of 14 mg patch, followed by two weeks of 7 mg.
16240103|NCT01085032|Drug|Placebo nicotine patch|"Subjects in the placebo condition receive an inert placebo patch matched for size, shape, color, and packaging.
~The same step-down dosing algorithm as in the experimental condition is used."
16240104|NCT01085019|Dietary Supplement|Cinnamon|2.8g/day of cinnamon in capsules during 4 weeks.
16240105|NCT01085019|Dietary Supplement|Oregano|2.8g/day of oregano in capsules during 4 weeks.
16240106|NCT01085019|Dietary Supplement|Ginger|2.8g/day of ginger in capsules during 4 weeks.
16240107|NCT01085019|Dietary Supplement|Rosemary|2.8g/day of rosemary in capsules during 4 weeks.
16240108|NCT01085019|Dietary Supplement|Black pepper|2.8g/day of black pepper in capsules for 4 weeks.
16240109|NCT01085019|Dietary Supplement|Placebo|2.8 g/day of placebo in capsules (corn starch) during 4 weeks.
16240110|NCT01085006|Drug|Tranexamic acid|Tranexamic acid in cases, normal saline in controls
16240111|NCT01085006|Drug|Normal saline|Tranexamic acid in cases, normal saline in controls
16240112|NCT01084993|Drug|Bivalirudin|Standard practice: 0.75mg/kg + infusion 1.75mg/kg/h
16240113|NCT01084993|Drug|Heparin|70 U/kg
16240114|NCT01084980|Drug|Tacrolimus|tacrolimus 0.05mg/kg bid for 12 weeks corticosteroid 0.3 - 0.5mg/kg qd
16240115|NCT01084941|Behavioral|Lifestyle Intervention group|Women on the intervention group will participate in a lifestyle program based on diet and moderate physical activity implemented shortly after first recognition of pregnancy. These women will attend monthly nutrition and physical activity educational sessions, and receive booster every 2 weeks.
16240116|NCT01084941|Behavioral|Standard of Care|Patients randomized to the standard of care group will receive counseling routinely provided to all prenatal care women as recommended by the Institute of Medicine for appropriate nutrition and weight gain and ACOG guidelines for appropriate physical activity during pregnancy.
16240156|NCT01084538|Drug|Zemplar iv (paricalcitol iv)|Each patient will be treated at the physician's discretion. Zemplar (paricalcitol) will be prescribed in the usual manner in accordance with the approved Summary of Product Characteristics.
16240157|NCT01084525|Drug|OTO-104 (steroid) 3 mg|OTO-104 3 mg dose cohort, single intratympanic injection.
16240158|NCT01084525|Drug|Placebo|Placebo arm will be conducted in parallel with each OTO-104 dose cohort.
16240188|NCT01084291|Biological|Investigational Vaccine for DEN1|Subcutaneous injection in upper arm of vaccine at dose of 10 plaque-forming units (PFU)
16240275|NCT01083615|Drug|cabazitaxel|
16240117|NCT01084928|Behavioral|Lifestyle Intervention Classes|The intervention will be based on the Diabetes Prevention Program but tailored to the needs of the community based on feedback gathered in focus groups. Classes will be group-based and will use a variety of teaching techniques and group-based work to teach participants about behavior change, diet, and physical activity. Participant will be required to attend one group exercise class per week based on traditional Indian dances and other culturally appropriate activities. In order to reach their weekly exercise goal of 150 minutes or more per week, participants will also be able to attend an additional group exercise class, an organized group walk, do a culturally-tailored work out video created by the study staff, and/or exercise on their own.
16240118|NCT01084902|Drug|Latanoprost|once daily
16240119|NCT01084902|Drug|Brinzolamide|Two times daily
16240120|NCT01084889|Device|surgical mesh implantation (TiLOOP® Total 6)|The standard procedure for the surgical repair of anterior prolapse is via the obturator membrane. The surgical mesh TiLOOP® Total 6 is placed transvaginal by the aid of TiLOOP® surgical instruments to place the mesh arms.
16240121|NCT01084876|Drug|CT-P6|Administered every 3 weeks
16240122|NCT01084876|Drug|Herceptin|Administered every 3 weeks
16240123|NCT01084876|Drug|Paclitaxel|Administered every 3weeks
16240124|NCT01084863|Drug|CT-P6|CT-P6: administered every 3 weeks
16240125|NCT01084863|Drug|Herceptin|Herceptin: administered every 3 weeks
16240126|NCT01084863|Drug|Paclitaxel|Paclitaxel: administered every 3 weeks
16240127|NCT01084837|Drug|velcade|"INDUCTIoN (Cycles 1-4)
~Bortezomib 1,3 mg/m2 i.v. days 1, 4, 8 and 11 follow by 10 days without treatment
~Dexamethasone 40 mg/p.o. days 1-4 and 9-12 cycles 1-4 (Cycles of 21 days)
~For patients wich is not planned autotransplantation, add:
~Cycles 5-8
~Bortezomib 1,3 mg/m2 i.v. days 1, 4, 8 and 11 follow by 10 days without treatment
~Dexamethasone 40 mg/v.o. days 1-4 (Cycles of 21 days)
~EXTENSION TREATMENT(Cycles 9-12)
~Bortezomib 1,3 mg/m2 i.v. days 1, 8, 15 and 22
~Dexamethasone 40 mg/d v.o. days 1-4 (Every 6 weeks)"
16240128|NCT01084824|Drug|Liquid nitrogen and cantharidin|Liquid nitrogen applied to wart(s), then cantharidin 1% topical applied afterward.
16240129|NCT01084824|Drug|Liquid nitrogen and topical placebo|Liquid nitrogen applied to wart(s), then placebo vehicle applied thereafter.
16240130|NCT01084811|Procedure|biopsy|One or more biopsies from nasal mucosa will be harvested during surgery
16240131|NCT01084772|Other|VISIONAIRE Total Knee Arthroplasty|TKA will be performed with VISIONAIRE instrumentation, depending on randomization assignment.
16240132|NCT01084772|Other|Standard Total Knee Arthroplasty|TKA will be performed with standard instrumentation, depending on randomization assignment.
16240133|NCT01084759|Drug|Testosterone injection|Patients will receive an intramuscular gluteal injection with testosterone cypionate at a dose of 400 mg every month for a total of 3 injections (i.e. 3 months of therapy). This route and dose of testosterone was selected based on data demonstrating that it produces an initial supraphysiologic serum level of testosterone (i.e. > 3-5 times normal level) with eugonadal levels achieved at the end of two weeks.
16240134|NCT01084759|Drug|Etoposide|On the day of testosterone injection (i.e. day 1 of each cycle) patients will begin therapy with oral etoposide at a dose of 100 mg/day given in divided doses (one 50 mg etoposide capsule q 12 h) for 14 consecutive days. This dose was selected based on Phase II studies of the combination of oral estramustine and oral etoposide. In these trials, myelosuppression was observed when etoposide was given for 21 days out of a 28 day cycle. Therefore, to minimize toxicity, in this study etoposide will be administered for 14 days of a 28 day cycle.
16240135|NCT01084746|Behavioral|PC-based tailored intervention|Patients will receive a tailored interactive PC-based intervention at a freestanding kiosk.
16240136|NCT01084746|Behavioral|Printed educational materials|Patients will receive generic printed educational materials about CRCS in the PEC when they arrive at the Main Campus for their appointment.
16240137|NCT01084720|Drug|V0034 CR|
16240138|NCT01084707|Drug|Oral Nicotine|Oral Nicotine either self-administered or provided by study personnel within 12 hours
16240139|NCT01084707|Drug|Nicotine Lozenge|Nicotine lozenge marketed as NiQuitin™ 4 mg hourly within 12 hours
16240140|NCT01084707|Drug|Nicotine gum|Nicotine gum marketed as Nicorette® 4 mg hourly within 12 hours
16240141|NCT01084681|Device|Endovascular treatment of intracranial aneurysms|Endovascular treatment with the SILK Artery Reconstruction Device for occluding intracranial aneurysms.
16240142|NCT01084681|Device|Endovascular treatment of intracranial aneurysm with coils|Endovascular treatment with commercially available intracranial coils for occluding intracranial aneurysms.
16240143|NCT01084655|Drug|TAK-700|TAK-700 with docetaxel and prednisone on a continuous schedule.
16240144|NCT01084655|Drug|Docetaxel|TAK-700 with docetaxel and prednisone on a continuous schedule.
16240145|NCT01084655|Drug|Prednisone|TAK-700 with docetaxel and prednisone on a continuous schedule.
16240146|NCT01084603|Drug|Oral Nicotine|A new l mg oral nicotine product
16240147|NCT01084603|Drug|NiQuitinTM Nicotine Lozenge|A marketed 4 mg Nicotine lozenge
16240148|NCT01084603|Drug|Nicorette® Nicotine Gum|A marketed 4 mg Nicotine Gum
16240149|NCT01084590|Behavioral|Healthy Eating/Physical Activity|This intervention arm will include brief pediatrician counseling regarding the child's current BMI percentile status, recommendations for home environmental changes to achieve a healthy weight gain trajectory, and home safety and injury risk reduction environmental recommendations paired with a 12 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the obesity prevention home environmental strategies.
16240150|NCT01084590|Behavioral|Safety/Injury Prevention|This intervention arm will include the same brief counseling from the pediatrician paired with a 12 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the safety and injury prevention home environmental strategies.
16240151|NCT01084577|Device|AQUACEL® Ag|AQUACEL® Ag dressing for four weeks followed by AQUACEL® for the remaining 4 weeks.
16240152|NCT01084577|Device|Urgotul® Silver|Urgotul® Silver for four weeks followed by Urgotul® for the remaining 4 weeks.
16240153|NCT01084551|Drug|SPM 962|once a daily transdermal administration started at 2.25 mg/day to 4.5 mg/day for 13 weeks
16240154|NCT01084551|Drug|SPM 962|once a daily transdermal administration started at 2.25 mg/day to 6.75 mg/day for 13 weeks
16240155|NCT01084551|Drug|Placebo of SPM 962|once a daily transdermal administration for 13 weeks
16240159|NCT01084525|Drug|OTO-104 (steroid) 12 mg|Sequential dose cohort escalation to OTO-104 12 mg dose cohort will occur pending the safety evaluation of 28 day follow up safety data for the OTO-104 3 mg dose cohort. OTO-104 12mg dose cohort is also a single intratympanic injection.
16240160|NCT01084499|Drug|Femara (Sequence 1)|Participant who is assigned to the Sequence 1 first receive Femara, then a Peratra. Each treatment period is separated by a 5-week washout period.
16240161|NCT01084499|Drug|Peratra (Sequence 1)|Participant who is assigned to the Sequence 1 first receive Femara, then a Peratra. Each treatment period is separated by a 5-week washout period.
16240162|NCT01084499|Drug|Femara (Sequence 2)|Participant who is assigned to the Sequence 2 first receive Peratra, then a Femara. Each treatment period is separated by a 5-week washout period.
16240163|NCT01084499|Drug|Peratra (Sequence 2)|Participant who is assigned to the Sequence 2 first receive Peratra, then a Femara. Each treatment period is separated by a 5-week washout period.
16240164|NCT01084486|Drug|Metformin|
16240165|NCT01084473|Drug|Dexmedetomidine|The study subjects will be given a normal loading dose (1 μg/kg in 20 minutes) of dexmedetomidine (dexmedetomidine hydrochloride 100 μg/ml, Precedex® Abbott Laboratories North Chicago, IL 60064, USA) followed by continuous infusion of 0.7 μg/kg/h for 190 min. The administration of the loading dose will be started at t = -30 min (30 min prior to the administration of paracetamol and lactulose).
16240166|NCT01084473|Drug|Morphine|The study subjects will be given 0.10 mg/kg morphine hydrochloride (morphine hydrochloride 2 mg/ml, Morphin® Nycomed Austria GmbH, St. Peter Strasse 25, A-4021, Linz, Austria) in 20 minutes followed by a placebo infusion for 190 min. The administration of the morphine infusion will be started at t = -30 min (30 min prior to the administration of paracetamol and lactulose).
16240167|NCT01084473|Drug|Placebo|0.9 % NaCl will be infused.
16240168|NCT01084447|Device|inspiratory muscle training|This daily respiratory exercise was performed from the 2nd day following surgery by using a linear pressure resistance device (Threshold ® IMT - Health Scan Products; USA)was initially set at 40% of the maximal inspiratory pressure, obtained in the 2nd post-operative day, being adjusted to every new maximal inspiratory pressure measurement.
16240169|NCT01084447|Device|control group|In placebo muscular training the daily respiratory exercise was performed from the 2nd day following surgery by using a linear pressure resistance device (Threshold ® IMT - Health Scan Products; USA)no load until the 30th post-operative day.
16240170|NCT01084434|Dietary Supplement|probiotic|Bifidobacterium lactis HN019 10^9 CFU/day 1 sachet once a day for 7 weeks
16240171|NCT01084434|Dietary Supplement|prebiotic|Galactooligosaccharide 5.5 g/day 1 sachet once a day for 7 weeks
16240172|NCT01084434|Dietary Supplement|Synbiotic|(Bifidobacterium lactis 10^9 CFU + Galactooligosaccharide 5.5g) / day - 1 sachet once a day for 7 weeks
16240173|NCT01084434|Dietary Supplement|Placebo|Maltodextrin 5.5g/day - 1 sachet once a day for 7 weeks
16240174|NCT01084421|Behavioral|Computer-based parent-adolescent HIV communication|The parental intervention consists of a 60 minute computer-based program delivered in two sessions (one per week). The DVD ROM provides information about adolescent sexual risk and HIV prevention, strategies to support sexual specific communication and parent-adolescent communication in general. The computer based education program is provided in Spanish.
16240175|NCT01084408|Device|SeQuent®Please (Paclitaxel coated balloon)|PCI of de-novo lesions
16240176|NCT01084408|Device|Taxus™Liberté™ (Paclitaxel eluting stent)|PCI of de-novo lesions
16240177|NCT01084395|Behavioral|Adolescent Safer Sex Intervention|Adolescents are randomly assigned to the HIV risk-reduction intervention condition. Adolescents receive a theory-based intervention designed to reduce HIV risk-associated behavior. The intervention consists of six 50-minute modules implemented over the course of two days. The intervention is highly interactive and includes games, videos, discussion, and role-plays.
16240178|NCT01084395|Behavioral|Parent Safer Sex Communication Intervention|Parents are randomly assigned to the Safer Sex Communication Intervention. Parents learn about HIV and other consequences of unprotected sexual behavior. The intervention contains content that focuses on enhancing parent-adolescent communication.
16240179|NCT01084395|Other|Adolescent Health Promotion Control Condition|Adolescents are randomly assigned to the Health Promotion control condition. Adolescents receive an intervention aimed at significant health problems affecting Mexicans that are related, not to sexual behavior, but to other behaviors. These health problems include heart disease, certain cancers, and diabetes. Adolescents are taught that these health problems can be prevented by changing personal behaviors, primarily exercise, diet, cigarette smoking, and alcohol and drug use.
16240180|NCT01084395|Other|Parent Health Promotion Control Condition|Parents are randomly assigned to the Health Promotion control condition. Parents receive an intervention aimed at significant health problems affecting Mexicans that are related, not to sexual behavior, but to other behaviors. These health problems include heart disease, certain cancers, and diabetes. Parents will be taught that these health problems can be prevented by changing personal behaviors, primarily exercise, diet, cigarette smoking, and alcohol and drug use. The intervention also provides content that emphasizes the importance of families.
16240181|NCT01084382|Dietary Supplement|Arthrospira platensis|"Patient take 5 gram supplement per day for 12 weeks in the first phase. In the second phase the two groups receive 5 gram per day of Arthrospira platensis for 12 weeks.
~One group will so haved received Arthrospira platensis for 24 weeks."
16240182|NCT01084369|Drug|Testosterone|"NEBIDO ampoules containing a solution for injection of 1000mg/4ml of testosterone undecanoate. NEBIDO injection 1000mg/4ml will be given at baseline, 6 weeks, 18 weeks, 30 weeks, 42 and 54 weeks. Levitra will be given to those patients with erectile dysfunction for 2 weeks in addition to Nebido.
~Concomitant medication deemed necessary by the investigator as part of the routine clinical management will be permissable."
16240183|NCT01084343|Biological|MYM-V101|"Panel 1: 2 vaccinations in the muscles followed by 2 vaccinations in the nose, 10 microgram or placebo each, every 8 weeks.
~Panel 2: 2 vaccinations in the muscles followed by 2 vaccinations in the nose, 50 microgram or placebo each, every 8 weeks."
16240184|NCT01084330|Drug|AUY922|70mg/m2
16240185|NCT01084330|Drug|Docetaxel|Docetaxel 75mg/m2
16240186|NCT01084330|Drug|Irinotecan|Iriniotecan 350mg/m2
16240187|NCT01084317|Other|medical documentation and telephone interview|medical documentation analysis supplemented by telephone interview conducted with parents of the child
16240189|NCT01084291|Other|Placebo injection|Subcutaneous injection of placebo
16240193|NCT01084265|Drug|Human chorionic gonadotropin (hCG)|After adequate follicular response, ovulation induction was triggered by an injection of 10,000 IU hCG.
16240194|NCT01084252|Drug|Isatuximab SAR650984|"Pharmaceutical form: solution for infusion
~Route of administration: intravenous"
16240195|NCT01084252|Drug|Dexamethasone|"Pharmaceutical form: solution for infusion
~Route of administration: intravenous"
16240196|NCT01084252|Drug|Dexamethasone|"Pharmaceutical form: tablet
~Route of administration: oral"
16240197|NCT01084239|Radiation|Cardiac Computed Tomography|A contrast enhanced cardiac CT was performed in addition to standard evaluation. Reconstructed data sets were evaluated for the presence of coronary artery calcium, coronary atherosclerotic plaque and stenosis, LV function and incidental findings.
16240198|NCT01084226|Dietary Supplement|Rye-2008|
16240199|NCT01084213|Drug|Intermittent screening and treatment of malaria in pregnancy (IST)|Scheduled intermittent screening of study women using rapid diagnostic test and treatment of those who are RDT positive during ante-natal clinic visits in the 2nd and 3rd trimester with arthemether lumefantrine.
16240200|NCT01084213|Drug|SP-IPTp|Study women will receive at least two doses of Sulfadoxine Pyrimethamine during their pregnancy, one at each of the recommended ante-natal visits during the 2nd and 3rd trimester.
16240201|NCT01084200|Drug|Propofol for maintenance|Propofol 6-8mg/kg/h + Remifentail 0.1-0.2ug/kg/min for anesthesia maintenance
16240202|NCT01084200|Drug|Sevoflurane|Sevoflurane 0.7-1.3MAC + Remifentail 0.1-0.2ug/kg/min for anesthesia maintenance
16240203|NCT01084200|Drug|Sevoflurane+Propofol|Sevoflurane 0.7-1.3MAC + Remifentanil 0.1-0.2ug/kg/min + Propofol 2mg/kg/h for anesthesia maintenance
16240204|NCT01084187|Drug|Vardenafil|vardenafil 20 mg on demand or vardenafil daily or placebo
16240205|NCT01084174|Drug|Peanut powder|Delivered orally
16240206|NCT01084174|Drug|Peanut extract|Delivered sublingually
16240207|NCT01084174|Drug|Placebo extract|Delivered sublingually
16240208|NCT01084174|Drug|Placebo powder|Delivered orally
16240209|NCT01084161|Drug|N1539|5 mg IV once per day
16240210|NCT01084161|Drug|N1539|7.5 mg IV once per day
16240211|NCT01084161|Drug|N1539|15 mg IV once per day
16240212|NCT01084161|Drug|N1539|30 mg IV once per day
16240213|NCT01084161|Drug|placebo|IV placebo once per day
16240214|NCT01084161|Drug|Morphine|morphine 10-15 mg IV once per day
16240215|NCT01084161|Drug|N1539|60 mg IV once per day
16240216|NCT01084148|Drug|V0034CR01B|
16240217|NCT01084148|Drug|V0034CR01B vehicle|
16240218|NCT01084135|Drug|Rivastigmine|At the baseline visit (week 0), the subject will begin rivastigmine treatment at a dose of 0.75 mg bid. This dose will be continued for two weeks and then increased to 1.5 mg bid for an additional eight weeks. At the week 10 safety visit, the dose will be increased to 4.5 mg/day (3.0 mg and 1.5 mg) for an additional 10 weeks. Subjects receiving placebo will maintain the same schedule. If a subject is unable to tolerate a particular dose, the dose will be lowered to the previously tolerated dose, down to a minimum of 0.75 mg bid. If the subject is unable to tolerate the 0.75 mg bid dose he/she will be dismissed from the study.
16240219|NCT01084135|Other|Liquid Placebo|Subjects receiving placebo will maintain matched titration volume increase as treatment arm. The placebo will be matched to liquid rivastigmine in consistency and taste.
16240220|NCT01084122|Drug|Iron sucrose|Iron sucrose FERIV® (20 mg/ml). Dilution: 10 ml in 100 ml SF 0.9%. 25 ml in 15 minutes and the rest in others 15 minutes.
16240221|NCT01084109|Other|Lyophilized meat|Daily intake of one half ounce of lyophilized meat between 6-18 months of age (0.5 oz for 6-12 mo; 0.75 oz for 12-18 mo)
16240222|NCT01084109|Other|Cereal|Daily intake of an equi-caloric fortified cereal as complementary feed from 6 to 18 months.
16240223|NCT01084096|Behavioral|Increasing use of Antenatal Corticosteroids (ACS)|"Intervention clusters:
~Increasing administration of ACS to pregnant women at high risk of preterm birth (HRPB) by providing health providers with kits containing dexamethasone, syringes, and instructions. Eligible women receive four injections of 6 mg dexamethasone from the kit or regimen of choice at the site.
~Improving identification of women at HRPB by diffusing recommendations for ACS use to health care providers, training health care providers to identify signs of preterm labor and eligibility criteria for ACS use, providing reminders to healthcare providers on the use of the kits, and using a color-coded tape to measure uterine height to estimate gestational age in women at HRPB with unknown gestational age.
~Control clusters: no specific intervention for comparison. Both intervention and control clusters: Birth attendants trained in essential newborn care of LBW infants and instructed to teach mothers how to provide care to premature infants."
16240224|NCT01084083|Biological|cetuximab|Given IV
16240225|NCT01084083|Radiation|intensity-modulated radiation therapy (IMRT)|Patients undergo low-dose OR standard dose IMRT based on their clinical response to induction therapy
16240226|NCT01084083|Drug|Paclitaxel|Given IV, 90 mg/m^2 on days 1, 8 and 15
16240227|NCT01084083|Drug|Cisplatin|Given IV, 75 mg/m^2 on day 1
16240228|NCT01084070|Other|Early oral feeding|"Within 6-24 hours after surgery the nasogastric tube will be removed and liquids and soft diet at will indicated."
16240229|NCT01084070|Other|Traditional Care|They will have nasogastric tube and restriction of oral intake until the first sign of restoration of intestinal transit (first flatus or stool, whichever comes first). Since then withdrew nasogastric tube and liquid diet starts within 24 hours, then continues with soft diet.
16240230|NCT01084057|Drug|vorinostat|Given orally
16240231|NCT01084057|Drug|ixabepilone|Given IV
16240232|NCT01084057|Other|laboratory biomarker analysis|Correlative studies
16240233|NCT01084057|Other|pharmacological study|Correlative studies
16240234|NCT01084044|Drug|ulinastatin, saline solution|the ulinastatin group receiving ulinastatin (300,000 unit after anesthesia induction and another 300,000 unit during Y- graft anastomosis, n = 40), the control group receiving the same volume of saline solution(n = 40)
16240235|NCT01084031|Drug|propofol|intravenous propofol with sevoflurane inhalation induction
16240276|NCT01083615|Drug|prednisone|
16240277|NCT01083602|Drug|panobinostat|PAN 20 mg PO given TIW, weeks 1&2 of each 3-week cycle;• BTZ 1.3 mg/m2 IV push given BIW weeks 1&2 of each 3 week cycle (days 1,4,8 and 11);• Dex 20 mg PO given QIW, weeks 1&2 of each 3-week cycle (days 1,2,4,5,8,9,11 and 12)
16240278|NCT01083602|Drug|bortezomib|
16240279|NCT01083602|Drug|dexamethasone|
16240236|NCT01084018|Behavioral|soulageTAVIE|VITaPaCS consists in a 30 minute-computer-tailored preoperative session, which is animated by a virtual nurse who guides the participant through a learning process about analgesic medication intake, pain communication, and cognitive restructuring. The information and the strategies provided are specifically tailored to the participants' profile, determined by a screening questionnaire, but also by their responses in real-time during the computer session. Two postoperative clinical reinforcements of ten minutes are also provided by the treating nurse based on the flags identified through the preoperative session.
16240237|NCT01084005|Drug|linagliptin|patients receive linagliptin 5 mg tablets once daily
16240238|NCT01084005|Drug|placebo|patients receive placebo matching linagliptin 5 mg once daily
16240239|NCT01083992|Drug|Galvus (vitagliptin)|Galvus (vitagliptin)
16240240|NCT01083992|Drug|Galvus + vitamin D|Galvus + vitamin D
16240241|NCT01083979|Drug|Liposomes|Intravesical instillation
16240242|NCT01083966|Drug|Bevacizumab (Avastin)|"Super-Selective Intraarterial Intracranial Infusion of Bevacizumab in Vestibular Schwannoma
~This phase I clinical research trial will test the hypothesis that Bevacizumab can be safely used by direct intracranial superselective intraarterial infusion up to a dose of 10mg/kg to ultimately enhance survival and hearing function of patients with VS"
16240243|NCT01083953|Drug|Sevoflurane|Comparing the optimal end-tidal concentration sevoflurane and desflurane for LMA extubation
16240244|NCT01083953|Drug|Desflurane|Comparing the optimal end-tidal concentration sevoflurane and desflurane for LMA extubation
16240245|NCT01083940|Other|Computerized reminders on hypertension intensification|Reminder generated to prompt providers to intensify therapy when patient's blood pressure remains uncontrolled
16240246|NCT01083927|Procedure|Rotational Narrow Strip Conjunctival Graft|Surgical technique
16240247|NCT01083927|Procedure|Full Conjunctival Graft|Surgical technique
16240248|NCT01083901|Behavioral|Resistance training|high intensity progressive resistance exercise training
16240249|NCT01083888|Drug|roxadustat|oral
16240250|NCT01083875|Drug|amlexanox|0.5% amlexanox oral rinse; use 5 ml every 2-3 hours during the awake hours of each day (a minimum of 6 times each day). The liquid was be swirled around the mouth then to be swallowed. Repeated daily until completion of radiation therapy: approximately 7-8 weeks.
16240251|NCT01083875|Drug|Vehicle rinse|use 5 ml of the vehicle rinse every 2-3 hours during the awake hours of each day (a minimum of 6 times each day). The liquid is be swirled around the mouth then swallowed.
16240252|NCT01083862|Behavioral|Educational Intervention - Text plus DVD/VHS|"In conjunction with a scheduled clinical visit, consenting patients spent roughly 40 minutes viewing a video program developed by the Foundation for Informed Decision Making (FIMDM), describing life-style and behavior modification for patients Living with Coronary Artery Disease. They also were given a booklet on the same subject material written at a 5th grade level."
16240253|NCT01083862|Behavioral|Educational Intervention - Text Only|"In conjunction with a scheduled clinical visit, consenting patients spent roughly 40 minutes reading a booklet developed by the Foundation for Informed Decision Making (FIMDM), describing life-style and behavior modification for patients Living with Coronary Artery Disease. Subject material was written at a 5th grade level."
16240254|NCT01083823|Other|Mental health telemetry (MHT)|Use a cell phone equipped with MHT software to complete a self-report mood symptom questionnaire daily at a fixed time of day, as well as additional discretionary questionnaires following any significantly stressful events.
16240255|NCT01083810|Drug|Lopinavir/Ritonavir (Kaletra)|3 capsules 2xdaily or 2 tablets 2xdaily Kaletra
16240256|NCT01083797|Drug|Dexmedetomidine|1 μg kg-1 infused in 10 min, and thereafter maintained from 0.2 to 0.7 μg kg-1 h- 1
16240257|NCT01083797|Drug|Chloral Hydrate|Initial dose=50 mg/kg
16240258|NCT01083784|Drug|Use of prophylactic anticonvulsants (valproate, clonazepam)|start at hypothermia induction valproate : 30mg/kg iv loading - 8hr after - 6mg/kg q 8hr iv till 72hr clonazepam : 1mg po bit via L-tube till 72 hr
16240259|NCT01083784|Drug|Control group|Control group
16240260|NCT01083771|Dietary Supplement|Olive Oil|Minimum of 3 tablespoon of olive oil per day
16240261|NCT01083758|Drug|LEO 80185 (Taclonex® Scalp topical suspension/Xamiol® gel)|Topical suspension applied once daily for up to 8 weeks
16240262|NCT01083732|Drug|dabigatran etexilate|Experimental dose chosen based on age and weight
16240263|NCT01083719|Procedure|FDG-PET|Fluoro-deoxy gluocose-Positron emission tomography for delineating volumes in Glioblastoma
16240264|NCT01083706|Drug|azacitidine|Given SC or IV
16240265|NCT01083706|Other|laboratory biomarker analysis|Correlative studies
16240266|NCT01083667|Drug|Pyrimethamine|Open Label, dose escalating,
16240267|NCT01083654|Behavioral|Standard Treatment Counseling|Standard Treatment Counseling will be based on recommendations in the 2008 U.S. Public Health Service Guideline (Treating Use and Dependence) including topics on preparing to quit, nicotine addiction, coping with stressors and challenging situations, coping with withdrawal symptoms, seeking support, and relapse prevention. Counseling will be delivered in an accessible, personalized manner by Ms. Fossum (an enrolled member of the Menominee Tribe) but no American Indian culturally-appropriate treatment elements will be incorporated into the counseling. In other words, the counseling in the Standard Treatment will be similar to the kind of evidence-based counseling offered to other smokers regardless of race or ethnicity.
16240268|NCT01083654|Behavioral|Culturally-Tailored Treatment|The Culturally-Tailored Treatment consists of the Standard Treatment Counseling plus culturally-appropriate treatment elements including: discussion of the long history of sacred/traditional use of tobacco (honoring and respecting native traditions) and how it differs from use of commercial tobacco use (harming health); custom booklet on smoking and smoking cessation tailored for Menominee and other American Indian smokers; and participants will be encouraged to make their own traditional tobacco pouch (symbol of long life)
16240269|NCT01083641|Drug|Estradiol|10mg oral three times daily
16240270|NCT01083628|Behavioral|Group CBT for Depression with MoodText|Mobile phone based text messaging to inquire about mood, cognitions, and behaviors on a daily basis.
16240271|NCT01083628|Behavioral|Group CBT for Depression|Standard group CBT for depression using BRIGHT manual
16240272|NCT01083615|Drug|custirsen sodium|An antisense oligonucleotide that blocks production of clusterin
16240273|NCT01083615|Drug|isotonic, 0.9% sodium chloride|Placebo for custirsen sodium
16240274|NCT01083615|Drug|docetaxel|
16240281|NCT01083589|Drug|Docetaxel|60 mg/m2 over 1 hour intravenous infusion repeated every 21 days.
16240282|NCT01083576|Drug|WR 279,396 (15% paromomycin + 0.5% gentamicin topical cream)|topical application to CL lesions once daily for 20 days
16240283|NCT01083576|Drug|Paromomycin Alone Cream (15% paromomycin topical cream)|topical application to CL lesions once daily for 20 days
16240284|NCT01083550|Other|Decision aid exposure|Exposure to a computerized decision aid on adjuvant radioactive iodine treatment decision-making. The exposure is during one visit.
16240285|NCT01083537|Drug|Cisplatin|"1) Cisplatin administered at 60mg/m2 IV on Day 1, every 21 days for 2 cycles.
~Hesketh Level 5: 5HT3 receptor antagonist IV/po 30-60 mins pre-chemo and Dexamethasone 10-20mg po/IV 30-60 mins pre-chemo; Dexamethasone 4-8mg po BID x 3 days starting 24hours post last dose of chemo; Prochlorperazine 10mg po/IV q4-6h prn, metoclopramide 10-20mg po/iv q6h prn, haloperidol 0.5-2mg po/SC q 8-12 h prn
~Hydration: Pre-hydration 500-1000cc NS with 10Meq KCl over 2 hours; Infuse Cisplatin in 250-500cc NS over 1 hour; Post-hydration 1000cc NS + 20Meq KCl (+/- 2g MgSO4) over 1 hour"
16240286|NCT01083537|Drug|Paclitaxel|"2) Paclitaxel administered 80mg/m2 IV on Days 1, 8 and 15, every 21 days for 2 cycles.
~Suggested prophylaxis for paclitaxel-associated hypersensitivity reactions: Dexamethasone 10-20mg po/IV 30-60 mins pre-chemo; diphenydramine 25-50mg IV 30-60 minutes pre-chemo, ranitidine 50mg IV 30-60 minutes pre-chemo
~Hesketh Level 2: Prochlorperazine 10mg po/IV q4-6h prn
~Hydration: Infuse Paclitaxel in 250cc NS over 1 hour"
16240287|NCT01083524|Drug|Dichloroacetate Sodium|3 mg po bid for 28 weeks
16240288|NCT01083524|Drug|Dichloroacetate Sodium|6.25 mg po bid
16240289|NCT01083524|Drug|Dichloroacetate Sodium|12.5 mg po bid
16240290|NCT01083498|Device|Ablative fractional laser therapy|10,600 nm ablative fractional laser Irradiance: 10 mJ/microbeam. Coverage: 35-45%. Number of treatment sessions: 3
16240291|NCT01083485|Drug|Oxycodone/Naloxone PR 20/10mg or 10/5mg tablets|Oxycodone/Naloxone prolonged release 20/10mg or 10/5mg tabs twice a day (BID) for 2.5 days (total 5 dosages)or Oxycodone 20mg
16240292|NCT01083485|Drug|Oxycodone|Oxycodone 20mg or 10mg BID for 2.5 days (total 5 dosages)
16240293|NCT01083472|Device|Strattice(TM) Reconstructive Tissue Matrix|Strattice(TM) TM will be used to support the repair of abdominal wall defect
16240294|NCT01083472|Procedure|Suture/suture with absorbable mesh|Abdominal wall defect will be repaired with suture alone or absorbable mesh with suture
16240295|NCT01083446|Other|Nutritional Intervention|Cognitive and executive functions before and after standard israeli breakfast (30% of caloric value and 21 gram protein)
16240296|NCT01083446|Other|Nutritional Intervention|Cognitive and executive functions during fast
16240297|NCT01083433|Behavioral|Diabetes related psychological counseling and education|The psychology intervention is based in part on an intervention to maintain parental support for diabetes care in adolescence which was developed by Anderson and colleagues (1999). The first session will include education to parents and children regarding the importance of sharing responsibility for treatment related tasks. The second session will include a discussion of the treatment sharing plan developed at the first visit and problems that may have occurred will be discussed. The third session will include a discussion of planning for possible future problems. Visits 1, 2, and 3 will include 30 minutes of diabetes education.
16240298|NCT01083433|Device|Continuous Glucose Monitor|Patients in the intensive diabetes clinic plus CGM group will wear the iPro after the baseline visit followed by every month for 4 months.
16240299|NCT01083420|Drug|Minocycline|Minocycline 0.2% mouthwash
16240300|NCT01083420|Drug|Dexamethasone|Dexamethasone 0.01% mouthwash
16240301|NCT01083407|Drug|0.12% Chlorhexidine Digluconate|Oral care with 0.12% Chlorhexidine Digluconate and toothbrushing is realized twice a day and took about 10 minutes to complete, depending on the child's acceptance and clinical conditions.
16240302|NCT01083407|Other|Toothbrushing|Gel is applied on a toothbrush, and the teeth are cleaned in quadrants; all teeth surfaces are cleaned (vestibular, lingual, occlusal, and incisal). After each quadrant is cleaned, 10 mL of water (dispensed via a syringe) is used to rinse the quadrant and continual aspiration is used to remove all the gel and debris. After all the teeth are cleaned, the ventral surface of the tongue is brushed with posteriorto-anterior movements.
16240303|NCT01083394|Device|PTA|PTA using a conventional balloon
16240304|NCT01083394|Device|PTA with PEB|PTA using a paclitaxel eluting balloon
16240305|NCT01083394|Procedure|Percutaneous Transluminal Angioplasty (PTA)|Percutaneous transluminal angioplasty with conventional balloon or paclitaxel-eluting balloon
16240306|NCT01083381|Drug|MS14|MS14 will be administered at an oral dose of 25-50 mg/kg/day in two divided doses for three months
16240307|NCT01083381|Drug|Risperidone|The treatment group receives Risperidone 2 mg per day in the beginning which is increased by 1 mg every day until reaching 4 mg/day; this regimen will be continued for three months.
16240308|NCT01083368|Drug|temsirolimus|Given IV
16240309|NCT01083368|Biological|bevacizumab|Given IV
16240310|NCT01083368|Genetic|polymorphism analysis|Correlative studies
16240311|NCT01083368|Other|laboratory biomarker analysis|Correlative studies
16240312|NCT01083342|Drug|MTX, MVD, VIA|MTX: Methotrexate,Leucovorin MVD: Methotrexate,Vincristine,Dexamethasone VIA: VP-16 (Etoposide),Ifosfamide,Mesna, Cytarabine (ara-C)
16240313|NCT01083329|Behavioral|training|the last 8 weeks, the subjects will follow a training program calculated to optimize use of lipid
16240314|NCT01083329|Drug|nicotinic acid|Obese subjects will receive nicotinic acid or placebo for 16 weeks
16240315|NCT01083329|Drug|Placebo|Obese subjects will receive nicotinic acid or placebo for 16 weeks
16240316|NCT01083316|Drug|Bortezomib|"Induction:
~Velcade 1.3 mg/m2/dose IV Days 1, 4, 8, 11 repeated every 21 days
~Conditioning:
~Bortezomib 1.0 mg/m2/dose will be administered on Days +6, -3, +1, + 4"
16240317|NCT01083316|Drug|Dexamethasone|"Induction:
~Dexamethasone 20 mg PO/IV Days 1, 4, 8, 11 repeated every 21 days"
16240318|NCT01083316|Drug|Melphalan|"Conditioning:
~Melphalan 70-100 mg/m2/day IV on days -2 and -1"
16240319|NCT01083303|Behavioral|Weaning Preterm Infants from an incubator|Eligible infants are to be randomized by computer generated random numbers to either the study group weaned at 1500 gr. or the control group weaned at 1600 gr. Both groups were weaned to a warming bassinet.
16240320|NCT01083290|Drug|Spironolactone|single dose of one tablet; 25 mg tablet
16240321|NCT01083290|Drug|Spironolactone|single dose of one tablet; 50 mg tablet
16240322|NCT01083290|Drug|Spironolactone|single dose of one tablet; 100 mg tablet
16240323|NCT01083277|Device|variable ventilation|In variable ventilation, the tidal volume on the Puritan-Bennett 840 ventilator will be randomly varied by 40% on a breath-by-breath basis around a pre-set mean, using the variable ventilation software developed by Dr. Bela Suki and Dr. Arnab Majumdar. In conventional ventilation, the tidal volume on the Puritan-Bennett 840 ventilator will be set to equal the mean tidal volume used in variable ventilation and does not vary.
16240324|NCT01083277|Other|Conventional ventilation|tidal volume will be set as the patient's baseline tidal volume prior to study entry and will not vary.
16240325|NCT01083264|Drug|Gestodene/EE Patch (BAY86-5016)|Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: buttocks
16240326|NCT01083264|Drug|Gestodene/EE Patch (BAY86-5016)|Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: arm
16240327|NCT01083264|Drug|Gestodene/EE Patch (BAY86-5016)|Transdermal Patch, 0.55mg Ethinylestradiol + 2.1mg Gestodene, 4x7 days patch wearing period, patch-free interval of 7 days, application site: abdomen
16240328|NCT01083251|Drug|Peginterferon + Vitamin D|180 mcg/week + 400 IUX2/day
16240329|NCT01083251|Drug|Peginterferon|180 mcg/week
16240330|NCT01083251|Drug|Sebivo|Telbivudine 600 mg daily
16240331|NCT01083251|Drug|entecavir+ vitamin d|entecavir 1 mg daily+ vitamin d
16240332|NCT01083238|Drug|AZD5069|120mg single oral dose
16240333|NCT01083225|Behavioral|Client feedback|Client feedback during consultations using ORS (Outcome rating scale) and SRS (Session rating scale).
16240334|NCT01083225|Behavioral|Treatment as usual|Treatment as usual, consultations
16240335|NCT01083212|Drug|AZD1656|Single dose,oral tablet
16240336|NCT01083212|Drug|Gemfibrozil|Oral tablet bid on day 1 - 5.
16240337|NCT01083212|Drug|Placebo|Oral tablet bid on day 1-5
16240338|NCT01083199|Device|CONTINUUM™|Performance of CONTINUUM™ in facilitating the vesico-urethral anastomosis following radical prostatectomy.
16240339|NCT01083147|Device|FORESEE HOME|Home Monitoring
16240340|NCT01083108|Other|Roux-en-Y Gastric Bypass|The surgical group will be studied before and 6 days after bariatric surgery.
16240341|NCT01083108|Other|Caloric Restriction|The non-surgical group will be studied before and after receiving a hypocaloric diet for 6 days mimicking the typical postoperative diet.
16240342|NCT01083095|Biological|Sporozoite Challenge Model for Plasmodium vivax in Humans|Eighteen naïve volunteers were exposed to the bite of carrying P. vivax sporozoites. Volunteers were randomly allocated to 1 of 6 groups and exposed to different numbers of mosquito biting, for 10 min. After feeding, dissection of all mosquitoes exposed in the cage was performed, to confirm the presence of a blood meal in their midguts and sporozoites in their salivary glands. If a volunteer did not get the number of infective bites assigned for his/her group, he/she was allowed to be bitten for a new group of mosquitoes until a total of 3±1, 6±1, or 9±1 mosquito bites were achieved.
16240343|NCT01083030|Procedure|Percutaneous transluminal angioplasty (PTA)|Angioplasty of superficial femoral artery (SFA)
16240344|NCT01083017|Drug|chlorthalidone|chlorthalidone 25mg/d vs. chlorthalidone 50mg/d
16240345|NCT01083017|Behavioral|motivational intervention for non-compliant individuals|motivational interview(s) vs. repeated calls vs. no particular intervention
16240346|NCT01083017|Drug|standardized anti-hypertensive treatment|olmesartan, amlodipine, chlorthalidone, +- spironolactone
16240347|NCT01083004|Procedure|Indocyanine green|Using indocyanine green as intraoperative dye
16240348|NCT01083004|Procedure|Brilliant blue arm|Using brilliant blue as intraoperative dye
16240349|NCT01082991|Other|Preemptive Rapid Response Team intervention|Non-ICU inpatients will be randomized on admission to an RRT surveillance group or standard of care. Daily risk prediction scores will be collected for all non-ICU inpatients. Those with high scores, who have been randomized to the surveillance arm, will be included on a list of patients, updated daily, that the Rapid Response Team will receive, with instructions to evaluate and intervene, if required, without waiting for formal activation by the usual channels.
16240350|NCT01082978|Device|Electronic (USB) Portable Health File|Patients randomized to this arm of the trial will be given a USB memory device that contains the Portable Health File (PHF) software. The portable health files contained core medical data which functions as a subset of a comprehensive medical record. The portable health file is updated by the health care provider at each visit and could also be updated by patient between visits if necessary.
16240351|NCT01082978|Device|Paper Portable Health File|Patients randomized to this arm of the trial will be given the paper Portable Health File. The paper Portable Health File contains core medical and other important data which functions as a subset of a more comprehensive medical record. This paper-based portable health file is updated by health care providers at each visit. The PHF can also be updated by patient between visits.
16240352|NCT01082965|Drug|Donepezil|5 mg tablets once daily for 7 days and then 10mg on 8th day
16240353|NCT01082965|Drug|Placebo|matching placebo
16240354|NCT01082939|Drug|Fludarabine|25 mg/m^2/day IV on Days 3-5; repeated every four weeks for a total of 6 planned cycles.
16240355|NCT01082939|Drug|Cyclophosphamide|250 mg/m^2/day IV on Days 3-5; repeated every four weeks for a total of 6 planned cycles.
16240356|NCT01082939|Drug|Alemtuzumab|30 mg IV on Days 1, 3 and 5 over 2-4 hours; repeated every four weeks for a total of 6 planned cycles.
16240357|NCT01082939|Drug|Rituximab|"Cycle 1 (Week 1): 375 mg/m^2/day IV on Day 2 over 4- 6 hours
~Cycle 2 - 6 (Week 1): 500 mg/m^2/day IV on Day 2 over 4- 6 hours"
16240358|NCT01082926|Biological|therapeutic allogeneic lymphocytes|Given intratumorally
16240359|NCT01082926|Biological|aldesleukin|Given intratumorally
16240360|NCT01082926|Other|laboratory biomarker analysis|Optional correlative studies
16240361|NCT01082926|Procedure|positron emission tomography|Optional correlative studies
16240362|NCT01082913|Device|SSE|Use of SSE or not use of SSE
16240363|NCT01082900|Other|Prophylactic CPAP Administration|"EXPERIMENTAL GROUP: Babies will receive prophylactic administration of CPAP (5 cm of H2O) in the Delivery Room via T piece (Neopuff)
~CONTROL GROUP: Provision of standard care in the Delivery Room"
16240444|NCT01082198|Biological|HLA-A1-binding MAGE-1/MAGE-3 multipeptide-pulsed autologous dendritic cell vaccine|
16241678|NCT01072201|Drug|Fluoride|Brush twice daily
16240364|NCT01082887|Other|TIL-Ad-INFg|After verification of inclusion and non-inclusion criteria and after obtaining informed consent from the patients, a tumor sample will be taken for sterile production of TIL. Patients will receive intra-tumoral injections of Ad-INFg every 15 days from J-15 to M2, then every month from M3 to M11 or until disease progression. The Ad-INFg will be administered by intra-tumoral injection at a dose of 5x1010 vp (viral particles) per lesion. A maximum of 6 lesions will be treated simultaneously. They will also receive two infusion of TIL at M0 (Cycle 1) and M1 (Cycle 2) by intravenous infusion lasting 30 to 65 minutes followed by subcutaneous injections of IL2 from J1 to J5 and from J8 to J12 of each cycle.An evaluation of injected and not injected tumoral lesions including photographs will be realised at the pre-inclusion visit, J-15, M0 and every month until M12.
16240365|NCT01082874|Drug|Active Clonidine|Pre-op (goal 2-4 hours): 2 x 0.1mg oral tablets and transdermal patch (0.2 mg/day). Patch to be removed 72 hours post-op.
16240366|NCT01082874|Drug|Placebo Clonidine|Pre-op (goal 2-4 hours): 2 oral placebo tablets and transdermal placebo patch. Patch to be removed 72 hours post-op.
16240367|NCT01082874|Drug|Active ASA|Pre-op (goal 2-4 hours): 2 x 100mg oral tablets. Post-op: patients ingest one tablet a day (100 mg ASA) for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
16240368|NCT01082874|Drug|Placebo ASA|Pre-op (goal 2-4 hours): 2 oral placebo tablets. Post-op: patients ingest one placebo tablet a day for 7 days if patient was were taking ASA chronically prior to surgery or for 30 days if they were not chronically taking ASA prior to surgery
16240369|NCT01082861|Biological|Cervarix|Cervarix, HPV vaccin
16240370|NCT01082861|Biological|Engerix-B|Engerix-B, HBV vaccin
16240371|NCT01082848|Drug|aripiprazole|10 mg QD during 26 weeks
16240372|NCT01082848|Drug|placebo|QD during 26 weeks
16240373|NCT01082822|Biological|cell sheet pellets and cell sheet fragment|the denuded root surface area was calculated to determine the size of the transplanted cell sheet in the of proportion of the 2cm X 2cm cell sheet to the 1cm X 1cm denuded area
16240374|NCT01082809|Drug|Sunitinib|Sunitinib 37.5 mg orally once daily continuously, comprising a 4-week cycle
16240375|NCT01082796|Drug|Glipizide|Each subject received 5 mg glipizide extended release tablet once daily for 7 days.
16240376|NCT01082770|Device|TEGO|A bung that can be attached to the end of dialysis lines that can be directly attached to the dialysis machine with minimal handling
16240377|NCT01082770|Device|Standard|Patients in this group will have a normal 'bung' placed at the end of their dialysis line, which will need to be removed by nursing staff prior to initiation of dialysis
16240378|NCT01082744|Drug|Ropivacaine + Sufentanil|Sufentanil at 0.25 µg/ml added to ropivacaine at 2 mg/ml at a perfusion rate of 0.15 ml/kg/h for continuous paravertebral block over 48 hours
16240379|NCT01082744|Drug|Ropivacaine|Ropivacaine at 2 mg/ml at a perfusion rate of 0.15 ml/kg/h for continuous paravertebral block over 48 hours
16240380|NCT01082731|Drug|Artemether-Lumefantrine|4 tablets containing 20 mg of artemether plus 120 mg of lumefantrine per tablet twice daily for three days as 2 doses 8 hours apart on the 1st day and then 2 doses 12 hours apart on the 2nd and 3rd days, administered with a fatty meal
16240381|NCT01082731|Drug|Mefloquine- Artesunate|Tablets of 100 mg artesunate and 220 mg mefloquine (fixed dose combination), given once daily for 3 days.
16240382|NCT01082718|Drug|Mefloquine Artesunate|Mefloquine-artesunate fixed dose combination (Farmanguinhos): Artesuanto 100 mg and Mefloquine 220mg per tablet, dosed once daily for 3 days such that mefloquine dose is approximately 8mg/kg/day.
16240383|NCT01082705|Drug|artemether-lumefantrine|administered twice daily for three days as tablets containing 20 mg of artemether plus 120 mg of lumefantrine at a dosage of: 1 tablet for patients weighing 5-14 kg, 2 tablets for patients weighing 15-24 kg, 3 tablets for patients weighing 25-34 kg, 4 tablets for patients weighing 35 kg or more
16240384|NCT01082705|Drug|Dihydroartemisinin-piperaquine|once daily for 3 days as tablets containing 40 mg of dihydroartemisinin and 320 mg of piperaquine at a total dosage of 6.4 mg/kg of dihydroartemisinin and 51.2 mg/kg of piperaquine divided equally between the three days
16240385|NCT01082692|Biological|PENNVAX-B|DNA plasmids delivered via IM injection + electroporation using CELLECTRA device
16240386|NCT01082679|Drug|Methadone|daily for 12 months
16240387|NCT01082679|Drug|buprenorphine (Suboxone)|daily for 12 months
16240388|NCT01082666|Device|Continuous control of cuff pressure|Continuous control of cuff pressure using a pneumatic device (Nosten, Leved, France)
16240389|NCT01082666|Device|Manual control of cuff pressure|Manual control of cuff pressure is a routine practice in ICU patients
16240390|NCT01082653|Biological|autologous bone marrow-derived stem cells|All patients will receive a unique one-time intrathecal infusion of the cell product suspended in infusion medium.
16240391|NCT01082640|Drug|Febuxostat|Febuxostat capsules
16240392|NCT01082640|Drug|Placebo|Febuxostat placebo-matching capsules
16240393|NCT01082627|Drug|Somatostatin|250ug/h,Continuous I.V. infusion,maximal 14 days
16240394|NCT01082627|Other|common daily practice|common daily practice
16240395|NCT01082614|Device|Vigileo|Pulse contour waveform analysis derived stroke volume variation will be used to guide intraoperative fluid administration. Additional fluid boluses will be given to the patient when SVV > 12%.
16240396|NCT01082601|Procedure|Pulmonary Vein Isolation (PVI)|Subjects with clinical indication for PVI, either paroxysmal or persistent AF failing medical management with rate or rhythm control medications.
16240397|NCT01082588|Drug|Pravastatin|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
16240398|NCT01082588|Drug|Placebo|pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks
16240399|NCT01082575|Device|Oxygen Monitoring|No intervention
16240400|NCT01082562|Drug|BMS-844421|"Ready-to-use stock solution for SC and IV, Subcutaneous, 37.5 mg
~SAD: Once, 1 Day
~MAD: IV loading followed by 4 weekly doses, 29 Days"
16240401|NCT01082562|Drug|0.9% sodium chloride injection solution|"Injection solution, Subcutaneous, 37.5 mg
~SAD: Once, 1 Day
~MAD: IV loading followed by 4 weekly doses, 29 Days"
16240402|NCT01082549|Drug|gemcitabine/carboplatin|i.v.
16240403|NCT01082549|Drug|gemcitabine/carboplatin plus Iniparib|i.v.
16240404|NCT01082523|Other|Text message reminders|Subjects in this arm will receive twice daily automated text messages reminding them to apply their medications.
16240405|NCT01082510|Drug|Bacille Calmette-Guerin|The patients in the BCG maintenance therapy arm will be treated with 3 successive weekly intravesical administrations of BCG at 3, 6, 12 and 18 months after the start of BCG induction therapy. The dosage of BCG used for the BCG maintenance therapy will be the same as that used for BCG induction therapy.
16240406|NCT01082510|Drug|uracil-tegafur|The UFT maintenance therapy arm patients will be treated with the oral administration of 400 mg of UFT everyday for three years after the end of BCG induction therapy.
16240407|NCT01082497|Behavioral|Mindfulness training|A course in mindfulness based stress reduction with 8 weekly group meetings and home practice between the meetings. Each meetings last for 90 minutes. Participants get workbook and cds to support home practice.
16240408|NCT01082484|Drug|treprostinil|Cutaneous iontophoresis at 20 microA/ 100 microA during 20 min
16240409|NCT01082484|Drug|iloprost|Cutaneous iontophoresis at 20 microA/ 100 microA during 20 min
16240410|NCT01082484|Drug|NaCl 0.9%|Cutaneous iontophoresis at 20 microA/ 100 microA during 20 min
16240411|NCT01082471|Drug|Morphine 6-glucuronide|
16240412|NCT01082471|Drug|Morphine|
16240413|NCT01082458|Drug|remifentanil / lidocaine|"Remifentanil TCI group : target controlled infusion of 2.0ng/ml of remifentanil on end of surgery.
~Lidocaine IV group : Intravenous administration of 1.5mg/kg of lidocaine on end of surgery."
16240414|NCT01082445|Drug|N-acetylcysteine|600 mg, 1 tablet 3 times a day for 3 months
16240415|NCT01082445|Drug|Placebo|Placebo
16240416|NCT01082432|Other|electrically induced muscle activation|30 Hz frequency, 200 µs pulse duration, and 40% duty cycle (4 sec on, 6 sec off)
16240417|NCT01082419|Device|ARFI measurement|"ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a light apnea.
~For group A the measurement is made by a second and a third investigator during the same examination."
16240418|NCT01082419|Device|ARFI measurement|"ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a light apnea.
~For all other groups (B, C, D, E) ARFI is measured only once."
16240419|NCT01082419|Device|ARFI measurement|"ARFI values are measured during a standard liver ultrasound examination, with patient lying on his back and performing a light apnea.
~For groups F and G : ARFI is measured again after clinical healing."
16240420|NCT01082406|Drug|catridecacog|Single dose of 35 IU/kg body weight recombinant factor XIII (catridecacog) (Novo Nordisk) administered iv (into the vein) followed by a single dose of 35 IU/kg body weight recombinant factor XIII (Avecia) administered iv.
16240421|NCT01082406|Drug|recombinant factor XIII|Single dose of 35 IU/kg body weight recombinant factor XIII (Avecia) to be administered iv (into the vein) followed by a single dose of 35 IU/kg body weight recombinant factor XIII (catridecacog) (Novo Nordisk) administered iv.
16240422|NCT01082393|Drug|topical tacrolimus treatment|4 applications (day 1,day 3, day 6 and day10)
16240423|NCT01082393|Drug|topical pimecrolimus treatment|4 applications (day 1, day 3, day 6 and day 10)
16240424|NCT01082393|Drug|local mometasone furoate treatment|4 applications (day 1, day 3, day 6 and day 10)
16240425|NCT01082393|Drug|cold cream|4 applications (day 1, day 3, day 6 and day 10)
16240426|NCT01082380|Drug|PF-02341066|oral suspension, single 250 mg dose of PF 02341066 containing approximately 100 µCi of [14C]PF 02341066
16240427|NCT01082367|Drug|TOBI|TOBI (tobramycin inhaled solution)
16240428|NCT01082367|Drug|Placebo|Placebo
16240429|NCT01082354|Drug|recombinant somatropin|as per standard practice
16240430|NCT01082341|Biological|Immunization with P. vivax irradiated sporozoites|"Anopheles albimanus mosquitoes will be infected by artificial membrane feeding using blood from P. vivax infected donors. Once mosquitoes are positive will be irradiated at 15000 cGy and kept in boxes until use.
~14 Fy(+) human volunteers in the experimental group will be immunized with 1,000-2,000 P. vivax irrad-spz bites. Seven Fy(+) volunteers in the control group will be exposed to non-infected mosquito bites. Six Fy(-) volunteers will be exposed to infective mosquito bites. For the challenge both the immunized and control groups will be exposed to 3 ± 1 infective mosquito bites. Volunteers will be closely monitored post infection and will be treated with antimalarials."
16240431|NCT01082328|Drug|Kuvan®|Kuvan® (sapropterin dihydrochloride) oral solution 20 milligram per kilogram (mg/kg) will be given once daily for 28 +/- 1 days.
16240432|NCT01082315|Drug|Erbitux (Cetuximab)|In subjects with mCRC, cetuximab will be used in combination with chemotherapy or as a single agent according to the approved national label as in routine clinical practice. Cetuximab 2mg/ml will be administered intravenously via in-line filtration with an infusion pump, gravity drip or a syringe pump. For the initial dose, the recommended infusion period is 120 minutes and for the subsequent weekly doses, the recommended infusion period is 60 minutes.
16240433|NCT01082302|Drug|Polyphenon E (Veregen) 15% ointment|3 times daily application on genital and perianal warts over 7 days
16240434|NCT01082302|Other|Green Tea Beverage with defined catechin content|3 times daily oral intake over 7 days
16240435|NCT01082289|Drug|Lurasidone|
16240436|NCT01082276|Drug|Lurasidone HCl|40mg, Single-dose of lurasidone 40 mg (one 40 mg tablet) on Day 1. Daily dosing of rifampin 600 mg (two 300 mg capsules) on Days 1-8. On Day 8, subjects will also receive a single-dose of lurasidone 40 mg (one 40 mg tablet).
16240437|NCT01082263|Drug|Lurasidone HCl|Day1: 5 mg midazolam (2.5 mL of the 2 mg/mL syrup) Day6: 120 mg lurasidone (three 40 mg tablets) + 5 mg midazolam (2.5 mL of the 2 mg/mL syrup) Day 7-12: 120 mg lurasidone (three 40 mg tablets) 120 mg lurasidone (three 40 mg tablets) on Day 13 + 5 mg midazolam (2.5 mL of the 2 mg/mL syrup)
16240438|NCT01082250|Drug|Lurasidone HCl|120mg dose. 3-way cross-over for 21 days
16240439|NCT01082237|Drug|Escitalopram|Start at 5mg per day, after four days increase to 10mg per day for the duration of the study. 20 mg will be administered at week 8 if not significantly better.
16240440|NCT01082224|Drug|iodinated contrast dye|iodinated Radiocontrast dye for imaging enhancement
16240441|NCT01082224|Drug|motexafin gadolinium|motexafin gadolinium
16240442|NCT01082224|Other|Eovist-enhanced MRI|A sub-study introduces the Eovist contrast agent for MRI scans at the same time points as the parent policy-assessment trial.
16240443|NCT01082211|Radiation|3D-Conformal External Beam|Radiation was to be delivered in 2 fractions per day, each of 1.5 Gy, separated by at least six hours, given in 15 consecutive working days to a total of 30 fractions and 45 Gy. Radiation was to be prescribed to the treatment unit isocenter, positioned at the approximate center of the planning target volume.
16240445|NCT01082198|Biological|HLA-A2-binding TYR/MART-1/gp100 multipeptide-pulsed autologous dendritic cell vaccine|
16240446|NCT01082198|Biological|autologous melanoma lysate-pulsed autologous dendritic cell vaccine|
16240447|NCT01082198|Biological|autologous melanoma lysate/KLH-pulsed autologous dendritic cell vaccine|
16240448|NCT01082198|Biological|dendritic cell-idiotype-keyhole limpet hemocyanin vaccine|
16240449|NCT01082198|Other|flow cytometry|
16240450|NCT01082198|Procedure|adjuvant therapy|
16240451|NCT01082185|Device|Ovation Abdominal Stent Graft System|Endovascular implant of Abdominal Aortic Aneurysm Stent Graft
16240452|NCT01082172|Device|Implant Thoracic Stent Graft|Endovascular implant of Thoracic Aortic Aneurysm Stent Graft
16240453|NCT01082159|Procedure|lumbar decompression|The mild® devices used in this study are specialized surgical instruments intended to be used to perform percutaneous lumbar decompressive procedures for the treatment of various spinal conditions.
16240454|NCT01082146|Drug|Lurasidone|40 mg suspension, PO, for 7 days
16240455|NCT01082120|Drug|AZD1656|Tablets orally, twice daily for 10 days
16240456|NCT01082120|Drug|Pioglitazone|Tablet oral single dose for 10 days
16240457|NCT01082107|Other|Solar disinfection in transparent containers (plastic bottles)|Participants in the study drink solar disinfected (SODIS) water. Solar disinfected water is water (> 3 L) that has been placed in direct sunlight for 6 hours. Participants are expected to drink SODIS treated water for the duration of the study.
16240458|NCT01082094|Biological|ACRX-100|Three cohorts (16 total subjects) will be studied. There will be no concurrent controls. The dose will be escalated by increasing the total amount of ACRX-100 delivered per subject from low dose (n=4 subjects) to middle dose (n=6 subjects) to high dose (n=6 subjects). ACRX-100 will be injected directly into the myocardium as a single dose at multiple sites through a percutaneous, left ventricular approach using a needle injection catheter.
16240459|NCT01082081|Drug|Paracetamol 1000 mg|Paracetamol 1000 mg
16240460|NCT01082081|Drug|Paracetamol 500 mg|Paracetamol 500 mg
16240461|NCT01082081|Drug|Placebo|Placebo
16240462|NCT01082068|Drug|XL147 (SAR245408)|given orally once daily as tablets
16240463|NCT01082068|Drug|XL765 (SAR245409)|given orally twice daily as capsules
16240464|NCT01082068|Drug|letrozole (Femara)|given orally once daily as tablets
16240465|NCT01082029|Drug|Lansoprazole|The dosage of Lansoprazole will be administered based on guidelines set out by the prescription drug information outlined in the official Lansoprazole package insert and will remain the same for each patient during the 3 month period and is as follows: a) 1 to 11 years of age, weight less then or equal to 30 kg, 15 mg orally once daily. b) 1 to 11 years of age, weight greater then 30 kg, 30 mg orally once daily. c) 12 years of age and older, 15 mg orally once daily. The doses of Lansoprazole will be prepared in liquid form by the Inpatient Pharmacy at Hamilton Health Sciences.
16240466|NCT01082029|Drug|Placebo|Lactose powder in 8.4% Sodium Bicarbonate (Liquid placebo)
16240467|NCT01082016|Other|Sleep Enhancement Program (SEP)|Sleep promotion in the ICU Multifaceted tool to promote sleep in ICU patients
16240468|NCT01082003|Drug|Trental|Trental (pentoxifylline) 400 milligrams three times a day in combination with vitamin E, 400 international units orally twice daily for six months.
16240469|NCT01081990|Drug|cyclobenzaprine|Cyclobenzaprine 5 mg TID for 7 days
16240470|NCT01081977|Procedure|Early Cord Clamping|Early Umbilical Cord Clamping (Clamping of Umbilical Cord within 30 seconds of shoulder delivery of neonate)
16240471|NCT01081977|Procedure|Delayed Cord Clamping|Delayed Umbilical Cord Clamping (Clamping Umbilical Cord after 2 minutes of shoulder delivery of neonate
16240472|NCT01081964|Drug|Zabofloxacin|Zabofloxacin 400mg capsule once daily for 3 days
16240473|NCT01081964|Drug|Levofloxacin 500mg|Levofloxacin 500mg orally for 7 days
16240474|NCT01081964|Drug|Zabofloxacin 400mg|Zabofloxacin 400mg orally for 5 days
16240475|NCT01081951|Drug|olaparib|Oral dose capsule 200mg BID day 1-10 of every 21 day cycle, Oral dose capsule 400mg BID continuously after completion of combination therapy
16240476|NCT01081951|Drug|paclitaxel|175mg/m2 iv for 6 cycles (18 weeks) day 1 of 21 day cycle
16240477|NCT01081951|Drug|carboplatin|AUC6 iv for 6 cycles (18 weeks) day 1 of 21 day cycle
16240478|NCT01081951|Drug|paclitaxel|175mg/m2 iv for up to 6 cycles (18 weeks)
16240479|NCT01081951|Drug|Drug: carboplatin|AUC4 iv for up to 6 cycles (18 weeks)
16240480|NCT01081938|Drug|INSULIN GLARGINE|"Pharmaceutical form: Lantus® (100 U/ml)
~Route of administration: Subcutaneous injection with SoloStar® (3 ml) pen device.
~Dose regimen: Single daily dose of Insulin Glargine"
16240481|NCT01081938|Drug|INSULIN GLULISINE|"Pharmaceutical form: Apidra® (100 U/ml)
~Route of administration: Subcutaneous injection with SoloStar® (3 ml) pen device
~Dose regimen:
~Arm1: Every 6 hours Arm2: several daily dose according to sliding scale of Insulin Glargine"
16240482|NCT01081912|Drug|Placebo|Capsules, no active substance, shells identical to active comparator capsules
16240483|NCT01081912|Drug|Hydrocodone bitartrate|"dosage form: capsule
~Strengths 10mg, 20mg, 30mg, 40mg, 50mg"
16240484|NCT01081899|Other|The LCP-I Program|The LCP-I Program is a continuous quality Improvement Program of end-of-life care implemented by a Palliative Care Unit (PCU) in a hospital Medical Ward.
16240485|NCT01081886|Device|PEAK PlasmaBlade 4.0|The PEAK PlasmaBlade will be used for the entirety of the total knee replacement, including the skin incision.
16240486|NCT01081886|Device|Traditional Electrosurgery with scalpel|Scalpel will be used for the skin incision and traditional electrosurgery for the subcutaneous dissection.
16240487|NCT01081873|Drug|leuprolide (Lucrin/Lucrin-Tri-depot)|Subcutaneous or intramuscular administration for all participants
16240488|NCT01081847|Drug|Peptides (N,R&C) formulated in Montanide ISA 720|50 ug
16240489|NCT01081847|Drug|Peptides (N,R&C) formulated in Montanide ISA 51|50 ug
16240490|NCT01081847|Drug|Peptides (N,R&C) formulated in Montanide ISA 720|100 ug
16240491|NCT01081847|Drug|Peptides (N,R&C) formulated in Montanide ISA 51|100 ug
16240492|NCT01081847|Other|Placebo|PLacebo: Isotonic saline solution
16240493|NCT01081834|Drug|Canagliflozin|One 100 mg or 300 mg over-encapsulated tablet orally (by mouth) once daily for 52 weeks (Main Study) or 26 weeks (High Glycemic Substudy)
16240494|NCT01081834|Drug|Placebo|One matching placebo capsule orally once daily for 26 weeks (Main Study)
16240495|NCT01081834|Drug|Sitagliptin|One 100 mg over-encapsulated tablet orally once daily beginning at Week 26 until Week 52 (Main Study)
16240496|NCT01081821|Drug|single dose NJ-39758979/ matching placebo|Single oral dose of JNJ-39758979 (either 50, 100, 300, 600mg) or Placebo
16240497|NCT01081821|Drug|multi-dose JNJ-39758979 /matching placebo|JNJ-39758979 once daily oral dose for 14 days of 300 mg or Placebo
16240498|NCT01081808|Biological|EGFRBi-armed autologous activated T cells|EGFRBi-armed autologous activated T cells infused twice a week for 4 weeks for a total of 8 infusions. The doses of the armed ATC will be escalated at the dose levels of 5, 10, 20, and 40 billion armed ATC per infusion. Subcutaneous aldesleukin (300,000IU/m2/day) and Sargramostim (250 ug/m2 twice per week) both starting 3 days before the 1st infusion and ending 7 days after the last dose of armed ATC.
16240499|NCT01081795|Drug|Topiramate|In the titration period, topiramate 25-mg tablet once daily orally for 1 week, the dose will be increased by 1 tablet every week up to twice daily for a total of 4 weeks so that the total daily dose given is 50 mg or 100mg. The dose given in the final titration week will be continued for further 18 weeks (fixed dose period).
16240500|NCT01081795|Drug|Placebo|In the titration period, matching placebo tablet once daily orally for 1 week, the dose will be increased by 1 tablet every week up to twice daily for a total of 4 weeks. The dose given in the final titration week will be continued for further 18 weeks (fixed dose period).
16240501|NCT01081782|Drug|ONO-4641|0.15 mg once per day for 26 weeks
16240502|NCT01081782|Drug|ONO-4641|0.1 mg once per day for 26 weeks
16240503|NCT01081782|Drug|ONO-4641|0.05 mg once per day for 26 weeks
16240504|NCT01081782|Drug|ONO-4641 placebo|Placebo once per day for 26 weeks
16240505|NCT01081769|Drug|paliperidone palmitate injection|injection with 150 mg equivalent on Day 1, 100 mg equivalent on Day 8, 75 mg equivalent on Day 38 and flexible dosing with 25, 50, 75, 100 or 150 mg equivalent once monthly thereafter
16240506|NCT01081769|Drug|oral antipsychotics|daily treatment according to local label for maximally 24 months
16240507|NCT01081756|Drug|r-hCG|r-hCG (250 mcg) injection subcutaneously (s.c.) or intramuscularly (i.m.)
16240508|NCT01081756|Drug|Urinary-hCG|Urinary hCG (10,000 IU) injection s.c. or i.m.
16240509|NCT01081743|Other|Intervention of the social worker|Systematic home visits and regular follow-ups by phone from a social worker
16240510|NCT01081730|Biological|anti-TNF biologics|as prescribed
16240511|NCT01081730|Other|general population|non-treated cohort
16240512|NCT01081730|Biological|non-anti-TNF biologics|as prescribed
16240513|NCT01081730|Biological|ustekinumab|as prescribed
16240514|NCT01081730|Drug|systemic non-biological treatments|as prescribed
16240515|NCT01081717|Drug|systemic non-biological treatments|as prescribed
16240516|NCT01081717|Biological|anti-TNF biologics|as prescribed
16240517|NCT01081717|Biological|golimumab|as prescribed
16240518|NCT01081717|Biological|non-anti-TNF biologics|as prescribed
16240519|NCT01081717|Other|general population|non-treated cohort
16240520|NCT01081704|Drug|ustekinumab|Single dose of 45 mg subcutaneous injection
16240521|NCT01081704|Drug|ustekinumab|Single dose of 90 mg subcutaneous injection
16240522|NCT01081691|Biological|CNTO 5825|10 mg/kg single dose IV or matching placebo
16240523|NCT01081691|Biological|CNTO 5825|3 mg/kg single dose IV or matching placebo
16240524|NCT01081691|Biological|CNTO 5825|For atopic patient:10 mg/kg single IV dose or matching placebo
16240525|NCT01081691|Biological|CNTO 5825|For atopic patient: 3 mg/kg single dose SC or matching placebo
16240526|NCT01081691|Biological|CNTO 5825|0.3 mg/kg single dose IV or matching placebo
16240527|NCT01081691|Biological|CNTO 5825|0.1 mg/kg single dose Intravenously (IV) or matching placebo
16240528|NCT01081691|Biological|CNTO 5825|1 mg/kg single dose IV or matching placebo
16240529|NCT01081678|Drug|Placebo|Administered by subcutaneous (under the skin) injection
16240530|NCT01081678|Drug|Romosozumab|Administered by subcutaneous injection
16240531|NCT01081652|Drug|Micronised Progesterone|Micronised progesterone administered intravaginally once daily from the day of ET. If pregnancy was confirmed on day 14 of progesterone administration, progesterone was continued for another 45 days.
16240532|NCT01081652|Drug|Progesterone|Progesterone 60 mg administered intramuscular once daily from the day of ET. If pregnancy was confirmed on day 14 of progesterone administration, progesterone was continued for another 45 days.
16240533|NCT01081639|Drug|Follitropin alfa liquid formulation|Follitropin alfa (Gonal-f) liquid pen (300, 450 and 900 IU) was applied by subcutaneous (sc) administration. Regimen of recombinant FSH-stimulation followed the standard protocol of the IVF-center
16240534|NCT01081639|Drug|Follitropin beta liquid formulation|Follitropin beta (Puregon) liquid cartridge (300 and 600 IU) used with the Pen was applied by sc administration. Regimen of recombinant FSH-stimulation followed the standard protocol of the IVF-center
16240535|NCT01081626|Drug|Recombinant FSH (follitropin alpha)|A starting dose of 75 IU and a first adjustment on Day 14 or Day 7 of stimulation in Group I and II respectively, if no ovarian response is observed.
16240536|NCT01081613|Other|89Zr-bevacizumab PET imaging|injection 89Zr-bevacizumab and 89 Zr-bevacizumab PET scan
16240537|NCT01081600|Other|Imaging with 89Zr-trastuzumab PET|Injection with 89Zr-trastuzumab and 89Zr-trastuzumab PET scan.
16240538|NCT01081587|Procedure|Access to a Computerized Clinical Decision Support System (CCDDS)|Automatic CCDSS will alert physician for each case of malnourished using an algorithm based on age, sex, weight and size of each hospitalized children.
16240539|NCT01081587|Behavioral|Education of Healthcare workers|Education of the hospital staff to evidence-based practices in malnutrition care will be proposed in the experimental arm. Specific training will be targeted on participants according to their function.
16240540|NCT01081587|Other|Local assistance by a dietician|Assistance will be conducted locally by a local dietician. Periodic multidisciplinary meetings will be attended by the hospital staff belonging to the intervention arm, including the analysis of clinical incidents related to nutrition care.
16240541|NCT01081574|Drug|Bilastine|10 mg/qd/ 7 days.Oral dispersible tablets
16240542|NCT01081561|Drug|Riboflavin|Removal of the epithelium, riboflavin drops every 2 minutes for 30 minutes follow by UV light radiation and addition riboflavin drops every 2 minutes for 30 minutes. Some subjects will be randomized to recieve INTACS prior to treatment with riboflavin.
16240549|NCT01081444|Device|rTMS|effective and active cortical magnetic stimulations
16240550|NCT01081444|Device|Placebo rTMS|non active cortical magnetic stimulation
16240551|NCT01081431|Drug|Lenalidomide|10 mg d1-d21 of a 28-day cycle
16240552|NCT01081418|Behavioral|Assertive Community Treatment (ACT)|ACT was structured and implemented according to guidelines of the Assertive Community Treatment Association (ACTA). Team members were highly educated psychosis experts consisting of a consultant psychiatrist, a psychiatrist, two psychologists, and a nurse, all of which received training in cognitive behavioral (CBT), dynamic, and/or family psychotherapy. Study participants could use all treatment options within the integrated care program such as psychoeducation groups, social skills training, family groups, motivational addiction therapy, meta-cognitive training etc.
16240553|NCT01081405|Other|TOTAL LYMPHOID IRRADIATION|Allogeneic Hematopoietic Cell Transplantation Using a Non-myeloablative Preparative Regimen of Total Lymphoid Irradiation and Anti-Thymocyte Globulin for Patients with Hematologic Malignancies
16240554|NCT01081392|Biological|LPS|LPS 20mcg sd inhaled via nebulizer, 3 periods
16240555|NCT01081353|Drug|Acetylsalicylic Acid (Aspirin BAY1019036)|One tablet of new formula Aspirin under fasting conditions
16240556|NCT01081353|Drug|Alka Seltzer Extra Strength|One effervescent tablet under fasting conditions
16240557|NCT01081353|Drug|Aspirin Migraine|One effervescent tablet under fasting conditions
16240558|NCT01081353|Drug|Aspirin Aspro|One effervescent tablet under fasting conditions
16240559|NCT01081340|Behavioral|Social network building intervention|Group support and health education sessions weekly during third trimester and once every two weeks until 6 months postpartum
16240560|NCT01081340|Behavioral|Home visit|Three home visits during third trimester and three during postpartum period until 6 months postpartum
16240561|NCT01081314|Behavioral|Dialectical Behavior Therapy|Standard Dialectical Behavior Therapy as described in the 2 DBT treatment manuals (Linehan, 1993a,b).
16240562|NCT01081314|Behavioral|PTSD Protocol|A modified version of Prolonged Exposure therapy for PTSD
16240563|NCT01081301|Behavioral|Living with Hope Program|"The LWHP consists of the LWH film featuring caregivers of patients with advanced cancer describing their hope and a hope activity Stories of the Present. Following viewing of the video with trained research assistants (RAs), (without discussion) the RA's will instruct the subjects to take 5 minutes at the end of the day and write about their thoughts, challenges and what gave them hope over a 2 week time period. Subjects can choose to use a journal, a computer or audiotape their journals."
16240564|NCT01081288|Other|Invitation for breast screening|Invitation for breast screening to women in different age groups
16240565|NCT01081275|Behavioral|CI Therapy|CI Therapy will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks.
16240566|NCT01081275|Behavioral|CAM treatments|CAM treatments will be given for 3.5 hours per day, Monday-Friday, for 2 consecutive weeks.
16240567|NCT01081262|Biological|Bevacizumab|Given IV
16240568|NCT01081262|Drug|Capecitabine|Given PO
16240569|NCT01081262|Drug|Carboplatin|Given IV
16240570|NCT01081262|Other|Laboratory Biomarker Analysis|Correlative studies
16240571|NCT01081262|Drug|Oxaliplatin|Given IV
16240572|NCT01081262|Drug|Paclitaxel|Given IV
16240573|NCT01081262|Other|Quality-of-Life Assessment|Ancillary studies
16240574|NCT01081249|Drug|Placebo then intranasal oxytocin|Participant received intranasal placebo spray at first psychotherapy session, and received a single dose of 40 IU intranasal oxytocin at the second session.
16240575|NCT01081249|Drug|Intranasal oxytocin then placebo|Participant received a single dose of 40 IU intranasal oxytocin at the first psychotherapy session, and received a similar dose of intranasal placebo spray at the second session.
16240576|NCT01081223|Biological|Cancer vaccine plus immune adjuvant, plus activated white blood cells|Tumor tissue is used for cancer vaccine. Following vaccinations, white blood cells are collected, stimulated and expanded, and are then reinfused. The infusion is followed by a course of low-dose IL-2.
16240577|NCT01081210|Other|Ultrasound examination|Screening with bedside ultrasound examination
16240578|NCT01081197|Other|Psychiatric and somatic examinations and ,if clinical indicated, treatment|Patients referred to the clinic will be given optimal treatment for revealed psychiatric and/or somatic disease including conversational therapy, and if indicated therapeutic interventions with respect to any kind of disease.
16240579|NCT01081184|Biological|blood sample|blood sample for determination of seric and lymphocytic NT profile will be added to a standard biological analysis done for pSS follow- up
16240580|NCT01081158|Drug|Drug: SCH 900518 Biologic: Peginterferon alfa-2b(PegIntron)|"Drug: SCH 900518
~Biologic: Peginterferon alfa-2b(PegIntron)
~Period 1: Amorphous SCH 900518 800 mg or placebo TID administered as an oral suspension for 7 days .
~Period 2: Amorphous SCH 900518 800 mg or placebo TID administered as an oral suspension for 14 days in combination with 1.5 µg/kg PegIntron administered subcutaneously weekly."
16240581|NCT01081158|Drug|Drug: SCH 900518 Biologic: Peginterferon alfa-2b|"Drug: SCH 900518
~Biologic: Peginterferon alfa-2b
~Period 1: Amorphous SCH 900518 800 mg or placebo TID administered as an oral suspension for 7 days
~Period 2: Amorphous SCH 900518 800 mg or placebo TID administered as an oral suspension for 14 days in combination with 1.5 µg/kg PegIntron administered subcutaneously weekly."
16240582|NCT01081158|Drug|Drug: SCH 900518 Drug: Ritonavir (RTV) Biologic: Peginterferon alfa-2b (PegIntron)|"Drug: SCH 900518
~Drug: Ritonavir (RTV)
~Biologic: Peginterferon alfa-2b (PegIntron)
~Period 1: Amorphous SCH 900518 (400 mg) or placebo BID administered as oral suspension + ritonavir (200 mg BID) (2-100 mg oral capsules) for 7 days.
~Period 2: Amorphous SCH 900518 (400 mg) or placebo BID administered as oral suspension+ ritonavir (200 mg BID) (2-100 mg oral capsules) + PegIntron (1.5 µg/kg QW) for 14 days."
16240583|NCT01081158|Drug|Drug: SCH 900518 Drug: Ritonavir (RTV) Drug: Ritonavir (RTV) Biologic: Peginterferon alfa-2b (PegIntron)|"Drug: SCH 900518
~Drug: Ritonavir (RTV)
~Biologic: Peginterferon alfa-2b (PegIntron)
~Period 1, Amorphous SCH 900518 (400 mg) or placebo BID administered as an oral suspension + RTV (200 mg BID) oral capsules (2-100 mg capsules) for 7 days.
~Period 2, SCH 900518 (400 mg) or placebo BID as an oral suspension + RTV (200 mg BID) oral capsules (2-100 mg capsules) +PegIntron (1.5 µg/kg SC QW) for 14 days."
16240584|NCT01081145|Drug|Extended-release Guanfacine Hydrochloride|The test product will be provided as 1, 2, 3, and 4mg tablets. Subjects will be administered a once-daily dose between 1-7mg/day depending on age and weight.
16241679|NCT01072188|Device|Arginine/Calcium Carbonate|One time treatment
16240585|NCT01081145|Other|Placebo|Matching placebo will be provided as 1, 2, 3, and 4mg tablets. Subjects will be administered a once-daily dose of placebo between 1-7mg/day depending on age and weight.
16240586|NCT01081132|Drug|Extended-release Guanfacine Hydrochloride|The test product will be provided as 1, 2, 3, and 4mg tablets. Subjects will be administered a once-daily dose between 1-7mg/day depending on weight.
16240587|NCT01081132|Other|Placebo|Matching placebo will be provided as 1,2,3, and 4mg tablets. Subjects will be administered a once-daily dose of placebo between 1-7mg/day depending on weight.
16240588|NCT01081119|Behavioral|Project CHOICE|Voluntary after school program offered 1 day per week for 30 minutes
16240589|NCT01081106|Procedure|Low-Level Laser Therapy|"A LLLT device at 670 nm will be used for light application using lasers affixed in a rotating helmet apparatus. Treatment will be given twice weekly prior to commencing chemotherapy and will be administered once a week until one week after the last chemotherapy.
~administration."
16240590|NCT01081093|Procedure|additional temporary pacewire|Placement of an additional pacing wire on the left side of the heart after aortic valve replacement in patients with hypertrophic cardiomyopathy
16240591|NCT01081054|Other|Ambulatory versus hospitalisation|Patients are treated with the same antibiotic agent, the difference between the two arms is endovenous treatment for hospitalized patients for the first days till oral feeding. The ambulatory group starts directly with orally administered antibiotic treatment.
16240592|NCT01081041|Drug|Cetuximab|Administered intravenously
16240593|NCT01081041|Drug|Cisplatin|Administered intravenously
16240594|NCT01081041|Drug|Carboplatin|Administered intravenously
16240595|NCT01081041|Drug|5-Fluorouracil|Administered intravenously
16240596|NCT01081002|Drug|Lidocaine 10%|3 min before the endoscopy under propofol sedation 4 puffs of lidocaine 10% will be sprayed on the pharynx as a pharyngeal anesthesia
16240597|NCT01081002|Drug|Diluted gentian root solution|As a basis, an infusion of water (45%), ethanol (35%) and gentian root cut will be used. The gentian root infusion is approved as a natural flavor in the food industry.3 min before the endoscopy under propofol sedation 4 puffs of this gentian root infusion will be sprayed on the pharynx as a pharyngeal anesthesia
16240598|NCT01080989|Other|diagnosis, treatment and education|"Drug:
~anti-intestinal parasitic drugs:
~mebendazole 500mg one dose (For Hook worm infections, Ascariasis, Trichuriasis)
~albendazole(400 mg bid * 7days) or Ivermectin(200 mcg/kg/day * 2 days) (For Strongyloidiasis).
~Behavior:
~Education capacity building (for local health personals): promote their ability of diagnosis and education to the community and patients for the associated diseases in this study.
~Assist the trained local health personals to educate the patients and the community from the design of teaching materials and the contents."
16240599|NCT01080963|Drug|Daptomycin|one infusion of 350 mg intraoperatively after disconnection from the heart-lung machine as an add-on to standard antibiotic prophylaxis
16240600|NCT01080963|Drug|Cefuroxime|1500 mg intravenous 30min preoperatively during anesthesia and 1500 mg intravenous intraoperatively after disconnection from the heart-lung machine
16240601|NCT01080924|Device|Low frequency ultrasound spectroscopy after broncholysis|Low frequency ultrasound spectroscopy is a novel non-invasive approach to real-time diagnostics of the lungs. Low frequency ultrasound at 10 to 1000 kHz permits monitoring of the air and water contents of the human thorax.
16240602|NCT01080911|Drug|Morphine|spinal morphine 0.05 mg
16240603|NCT01080911|Drug|Morphine|spinal morphine 0.1 mg plus 0.5% heavy marcaine 3.5 ml
16240604|NCT01080898|Other|tests|color photographs, FLUORESCEIN angiography and OCT
16240605|NCT01080885|Behavioral|Busy Bodies/Better Bites|This intervention will include brief counseling from the pediatrician paired with a 6 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the healthy eating and physical activity home environmental strategies.
16240606|NCT01080885|Behavioral|Healthy Spots/Safe Tots|This intervention will include the same brief counseling from the pediatrician paired with a 6 month home-based program delivered via phone by a masters-level health behavior specialist to promote implementation of the safety and injury prevention home environmental strategies.
16240607|NCT01080872|Device|CFR|CFR will be assessed using transthoracic echocardiography with adenosine infusion.
16240608|NCT01080859|Device|OCT|Optical coherence tomography
16240609|NCT01080859|Device|OCT|Optical coherence tomography
16240610|NCT01080846|Drug|Misoprostol|600 mcg of sublingual misoprostol
16240611|NCT01080833|Device|ERCP mechanical simulator practice|Trainees will receive ERCP mechanical simulator practice in addition to routine ERCP training
16240612|NCT01080820|Drug|CMX157|One single oral dose of CMX157 will be administered and the option of receiving a single dose of 300mg Viread will be offered 4-8 weeks after the CMX157 dose.
16240613|NCT01080820|Drug|Placebo|One single oral dose of placebo will be administered and the option of receiving a single dose of 300mg Viread will be offered 4-8 weeks after the placebo dose.
16240614|NCT01080820|Drug|Viread|One single oral dose of 300mg Viread.
16240615|NCT01080807|Drug|Armodafinil|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
16240616|NCT01080807|Drug|Matching Placebo|At the baseline visit, patients who continued to meet eligibility criteria were randomly assigned (1:1) to receive either 150 mg of armodafinil or matching placebo treatment only on nights worked for 6 weeks. Study drug was taken once nightly, 30 to 60 minutes prior to the start of the night shift, on nights worked. Armodafinil treatment was titrated as follows (only on nights worked): the first dose was 50 mg (1 tablet), the second and third doses were 100 mg (2 tablets), and the fourth and subsequent doses were 150 mg (3 tablets). Placebo tablets matching armodafinil tablets were administered on the same schedule.
16240657|NCT01080508|Other|ventilation after intubation with special tube|Description of the pressure waveforms during esophageal ventilation
16240658|NCT01080495|Procedure|TEE (transesophageal echocardiography)|a TEE is performed in all study objects and all parameters (radial strain, fractional shortening and fractional area change) are analysed
16240617|NCT01080794|Device|Repetitive transcranial magnetic stimulation (rTMS)|"DLPFC Active rTMS: Each treatment will consist of 2000 stimuli (50 X 4-second trains of 40 stimuli at 10 Hz, administered every 30 seconds for 25 minutes). Stimulus intensity for the first and second trains will be 80 and 90 percent of motor evoked potential (MEP), respectively. If no adverse effects are observed following each of the first two trains, then the subsequent trains will be given at MEP threshold.
~M1 Active rTMS: Stimulation will be applied one side at a time, to the motor cortex site at 90 percent of each subject's motor threshold intensity, and at a frequency of 10 Hz with 1000 stimuli per side (25 X 8-second trains of 40 stimuli).
~Sham rTMS: Patients from all four centers randomized to receive sham treatment will undergo the same procedures used in patients receiving active rTMS."
16240618|NCT01080768|Drug|Aliskiren/amlodipine|Aliskiren/amlodipine 150/5 mg/day
16240619|NCT01080768|Drug|Amlodipine|Amlodipine 5 mg/day.
16240620|NCT01080768|Drug|Placebo to Aliskiren/amlodipine|Placebo to Aliskiren/amlodipine 150/10 mg/day
16240621|NCT01080768|Drug|Placebo to Amlodipine|Placebo to Amlodipine 5 mg/day
16240622|NCT01080742|Drug|Lodoz (Combination of bisoprolol and hydrochlorothiazide)|The investigator will decide in advance the best therapeutic strategy for each subject according to current practice, regardless of the potential participation of this subject in the study.
16240623|NCT01080729|Drug|Recombinant-follicle stimulating hormone (r-FSH)|"The dosage and administration of r-FSH will be in accordance with the PFS and current clinical practice in the centers (300 IU/0.5 ml [22 micrograms/0.5 ml]; 450 IU/0.75 ml [33 micrograms/0.75 ml]; or 900 IU/1.5 ml [66 micrograms/1.5 ml].
~The dosage and administration of recombinant-hCG (r-hCG; 250 micrograms/0.5 ml), injectable solution in a pre-filled syringe will also be in accordance with the PFS and current clinical practice in the centers (only if the doctor decides to start treatment with r-hCG)."
16240624|NCT01080716|Biological|Part 1/Arm 1 of Study: WRSS1 vaccine|Single, oral dose of WRSS1
16240625|NCT01080716|Biological|Part 1/Arm 2 of Study: Placebo vaccine|Placebo vaccine
16240626|NCT01080716|Biological|Part 2/Arm 1 of Study: S. sonnei 53G|Subject from Part 1/Arm 1 of Study are given 53G S. sonnei
16240627|NCT01080716|Biological|Part 2/Arm 2 of Study: S. sonnei 53G|10 naïve controls are given S. sonnei 53G
16240628|NCT01080703|Other|Exercise|Lower extremity resistance exercises and aerobic exercises 3 times a week in 10 week pulmonary rehabilitation program prior to lung transplant.
16240629|NCT01080690|Procedure|EGD|In this arm EGD will be performed before EUS.
16240630|NCT01080690|Procedure|EUS|In this arm EUS will be performed before EGD.
16240631|NCT01080677|Drug|caffeine/propranolol combination tablet|caffeine/propranolol combination tablet administered orally once daily
16240632|NCT01080677|Drug|placebo|placebo to match caffeine/propranolol combination tablet administered orally once daily
16240633|NCT01080664|Drug|AS703569|"Dose Escalation
~Regimen 1 - 3-47 mg/m2/day, orally once daily on days 1, 2,3 and 8, 9, 10 of a 21 day cycle:
~Number of cycles: until progression or unacceptable toxicity develops.
~Cohort Expansion
~Regimen 1 - Maximum tolerated dose from dose-escalation part or a lower dose in mg/m2/day, orally once daily on days 1, 2,3 and 8, 9, 10 of a 21 day cycle:
~Number of cycles: until progression or unacceptable toxicity develops"
16240634|NCT01080664|Drug|AS703569|"Dose Escalation Regimen 2 - 3-47 mg/m2/day, orally once daily on days 1, 2, 3, 4, 5, 6 of a 21 day cycle Number of cycles: until progression or unacceptable toxicity develops.
~Cohort Expansion Regimen 2 - Maximum tolerated dose from dose-escalation part or a lower dose in mg/m2/day, orally once daily on days 1, 2, 3, 4, 5, 6 of a 21 day cycle Number of cycles: until progression or unacceptable toxicity develops."
16240635|NCT01080651|Drug|Voriconazole|Day1: voriconazole 200 mg x 2, oral administration, Day2-7: rifampin 600 mg, once a day oral administration, Day8: voriconazole 200 mg x 2 + rifampin 600 mg, oral co-administration
16240636|NCT01080638|Drug|glycoprotein IIb/IIIa inhibitor (abciximab)|patients intracoronary bolus only group and intravenous bolus and 12-hours continuous infusion group bolus:0.25mg/kg body weight,continus 12hrs-0.125ug/kg per minute(maximum: 10ug/min)
16240637|NCT01080625|Drug|phenylephrine|100 mcg of phenylephrine (volume 10 ml) iv at the time of reperfusion
16240638|NCT01080625|Drug|epinephrine|10mcg of epinephrine (volume 10 ml) is administered iv at the time of reperfusion
16240639|NCT01080625|Drug|placebo control|10ml of normal saline is administered at the time of reperfusion
16240640|NCT01080612|Drug|330 mg pregabalin controlled release|A single dose of 330 mg controlled release tablet will be administered following a 400 to 500 calorie meal
16240641|NCT01080612|Drug|330 mg pregabalin controlled release|A single dose of 330 mg controlled release tablet will be administered following a 600 to 750 calorie meal
16240642|NCT01080612|Drug|330 mg pregabalin controlled release|A single dose of 330 mg controlled release tablet will be administered following an 800 to 1000 calorie meal
16240643|NCT01080612|Drug|300 mg pregabalin immediate release|A single dose of 300 mg immediate release capsule will be administered in the fasted state
16240644|NCT01080599|Procedure|obturator nerve block|
16240645|NCT01080586|Drug|Cyclosporine Capsules USP (Modified) 100 mg|Subjects will be administered either Test Product or Reference Product with 240ml of water according to randomization schedule
16240646|NCT01080560|Drug|Cyclosporine Capsules USP (Modified) 100 mg|Subjects will be administered either Test Product or Reference Product with 240ml of water according to randomization schedule
16240647|NCT01080547|Procedure|Laparoscopic Surgery for Colorectal Cancer|Laparoscopic surgery for colorectal cancer using STORZ laparoscope
16240648|NCT01080547|Drug|XELOX Chemotherapy|XELOX chemotherapy
16240649|NCT01080547|Drug|mFolfox6 chemotherapy|Conventional (mFolfox6) chemotherapy
16240650|NCT01080547|Other|Fast Track Perioperative Treatment|Fast track treatment during perioperation period
16240651|NCT01080547|Other|Conventional Perioperative Treatment|Conventional treatment during perioperation period
16240652|NCT01080547|Procedure|Open Surgery for Colorectal Cancer|Open surgery for colorectal cancer using conventional methods
16240653|NCT01080534|Drug|Tacrolimus 5 mg Capsule|Subjects will be administered either Test Product or Reference Product with 240 mL of water according to randomization schedule
16240654|NCT01080521|Procedure|Cognitive Assessment|Ancillary studies
16240655|NCT01080521|Other|Quality-of-Life Assessment|Ancillary studies
16240656|NCT01080508|Other|tracheal ventilation with regular tube|Description of the pressure waveforms during tracheal ventilation
16240659|NCT01080482|Drug|Tacrolimus 5 mg Capsule|Subjects will be administered either Test Product or Reference Product with 240 mL of water according to randomization schedule
16240660|NCT01080469|Drug|Tacrolimus 1 mg Capsule|Subjects will be administered either Test Product or Reference Product with 240 mL of water according to randomization schedule
16240661|NCT01080456|Drug|Tacrolimus 1 mg capsule|Subjects will be administered either Test Product or Reference Product with 240 mL of water according to randomization schedule
16240662|NCT01080443|Drug|Mycophenolate Mofetil Capsule 250 mg|Subjects will be administered either Test Product or Reference Product with 240 mL of water according to randomization schedule
16240663|NCT01080430|Other|rehabilitation maneuver|rotation in the direction of the weak vestibular response, every 3-7 days over a period of a month. Each rotation lasts about 2 minutes and a total of 3-7 rotations are used per session.
16240664|NCT01080417|Drug|Mycophenolate Mofetil Capsule 250 mg|Subjects will be administered either Test Product or Reference Product with 240 mL of water according to randomization schedule
16240665|NCT01080404|Procedure|Bariatric surgery|A standardized laparoscopic gastric bypass using Roux-en-Y technique
16240666|NCT01080404|Device|Continuous positive airway pressure|The patients are given standardized CPAP treatment according to current clinical guidelines.
16240667|NCT01080391|Drug|Dexamethasone|40 mg orally or IV on days 1, 8, 15, 22
16240668|NCT01080391|Drug|Lenalidomide|25 mg orally on days 1-21
16240669|NCT01080391|Drug|Carfilzomib|20 mg/m², 27 mg/m² intravenously
16240670|NCT01080378|Procedure|Dietary and Exercise Intervention|Participants will be enrolled into a 16 weeks weight loss programme that consists of (a) dietary interventions and (b) structured exercise sessions and (c) physical activity to achieve 7 - 10% decrease (more than 8 kg) in initial body weight in 16 weeks. They will be subjected to a caloric deficit of 40% of the subject's energy expenditure or 1000kcal, which ever it is higher. (allowance given for dietary control and physical activity).
16240671|NCT01080365|Drug|SKI-606 (Bosutinib)|500 mg commercial formulation film coated tablet, administered once daily
16240672|NCT01080365|Drug|SKI-606 (Bosutinib)|500 mg (5 ×100 mg) phase 3 formulation film coated tablets, administered orally once daily
16240673|NCT01080352|Drug|Ascorbic Acid (Vitamin C)|60grams of ascorbate given intravenous infusion in 1000ml sterile water.
16240674|NCT01080326|Device|Endoscopic Translumenal Omental Patch|The endoscope will be gently advanced through the ulcer. Irrigation with saline will proceed. Then a viable mobile piece of omentum will be identified and pulled into the ulcer. After the omentum is located in the stomach, clips will be used to fix it in place.
16240675|NCT01080313|Other|Therapy for head and neck cancer|radiotherapy and/or drug therapy including chemotherapy, biologic therapy and targeted therapy
16240676|NCT01080300|Drug|Gabapentin Extended Release|Gabapentin ER 1800mg daily
16240677|NCT01080300|Drug|Placebo|Sugar pill
16240678|NCT01080261|Device|PROMUS Element|PROMUS Element Everolimus-Eluting Coronary Stent System
16240679|NCT01080248|Drug|Gemcitabine|
16240680|NCT01080248|Drug|Pazopanib|
16240681|NCT01080235|Other|ABIM Care of Vulnerable Elderly Practice Improvement Module|The ABIM CoVE PIM is a practice-performance self-evaluation instrument. It is a web-based tool based on nationally recognized guidelines that uses chart abstraction, patient surveys, and a practice system survey in order to generate a performance report focused on a key aspects of care for vulnerable elderly.
16240682|NCT01080235|Other|Geriatric and Quality Improvement toolkit|A resource toolkit about geriatrics and quality improvement was given to both study arms.
16240683|NCT01080222|Drug|telaprevir|tablet, 1125-mg, twice daily
16240684|NCT01080222|Drug|VX-222|capsule, 100-mg, twice daily
16240685|NCT01080222|Drug|ribavirin|tablet, 1000-mg for subjects weighing <75-kg or 1200-mg for subjects weighing ≥75-kg, twice daily
16240686|NCT01080222|Biological|peginterferon-alfa-2a|subcutaneous injection, 180-mcg, once weekly
16240687|NCT01080222|Drug|VX-222|capsule, 400-mg, twice daily
16240688|NCT01080209|Drug|Brimo PS DDS®|Patients who received Brimo PS DDS® intravitreal implant in a previous study.
16240689|NCT01080209|Other|Sham|Patients who recieved sham in a previous study.
16240690|NCT01080196|Behavioral|RENEW|"RENEW will occur on a recumbent ergometer that appears like a normal stepper ergometer. While resisting the foot pedal movement the participant experiences eccentric muscle contractions about the knee and hip while performing negative work. The progression of the 3 x/week (every other day), 12 week RENEW program will be determined as a function of the rating of perceived exertion (RPE) using a target workload on the monitor. RENEW will be increased very slowly over the first 3 weeks and, subsequently, to maintain an 11-13 perceived exertion. During the formal RENEW training regimen the participants become fully acclimated to the device (week 3-4) the total RENEW load will increase weekly with no increase in their RPE."
16240691|NCT01080183|Other|Patient feedback form|patients receive a report that feeds back their patient reported measures to them prior to their clinical visit
16240692|NCT01080157|Device|SCOUT DS measurement|Non-invasive 3-5 volar forearm scan
16240693|NCT01080144|Other|Critical flicker frequency procedure|After TIPS, patients will be followed during one year and the psychometric test and Critical flicker frequency procedure will be performed every 3 months
16240694|NCT01080131|Drug|Canakinumab 150 mg|Canakinumab 150 mg was supplied in 6 mL glass vials each containing nominally 150 mg canakinumab (plus 20% overfill).
16240695|NCT01080131|Drug|Triamcinolone acetonide 40 mg|Triamcinolone acetonide 40 mg was supplied as a suspension.
16240696|NCT01080131|Drug|Placebo to canakinumab|Placebo to canakinumab was supplied in 6 mL glass vials containing placebo powder as a lyophilized cake.
16240697|NCT01080131|Drug|Placebo to triamcinolone acetonide|Placebo triamcinolone acetonide was supplied as a lipid emulsion similar in appearance to triamcinolone acetonide.
16240698|NCT01080118|Device|Airtraq|Subjects were taught with the Airtraq video laryngoscope
16240699|NCT01080118|Other|Control group, taught with a standard Macintosh laryngoscope|Subjects were taught how to use the Mackintosh blade first
16240700|NCT01080105|Behavioral|AIM Web based intervention + surveillance|The web based intervention will include 12 weeks of Internet-based cognitive behavioral therapy combined with brief telephone and email support from a coach. Surveillance will consist of monthly screening of depression symptoms and outreach from the coach should there be an increase in symptoms.
16240701|NCT01080105|Behavioral|AIM web based intervention|The web based intervention will include 12 weeks of Internet-based cognitive behavioral therapy combined with brief telephone and email support from a coach.
16240702|NCT01080105|Behavioral|Educational website|Participants will receive access to a static educational website for 12 weeks.
16240703|NCT01080092|Behavioral|breathing technique|breathing technique as a stress management technique, reinforced by biofeedback
16240704|NCT01080092|Behavioral|behavioral strategies|the control group reads a paper on the properties and components of tobacco and on behavioural strategies to cope with craving
16240705|NCT01080079|Drug|Terbinafine Hydrochloride|4% w/w Terbinafine Hydrochloride Gel
16240706|NCT01080079|Other|Purified Water|Purified Water
16240707|NCT01080066|Other|No Intervention|Subjects administered with Cetuximab, once weekly by intravenous infusion at a first dose of 400 milligram per square meter (mg/m^2) body surface area for 120 minutes infusion period and subsequently at a dose of 250 mg/m^2 for 60 minutes infusion period, will be observed. The maximum infusion rate must not exceed 10 milligram per minute (mg/min).
16240708|NCT01080027|Drug|Rebif® New Formulation|The recommended dose of Rebif® is 22 or 44 μg administered three times per week by subcutaneous injection.
16240709|NCT01079988|Drug|Cyclosporins|Starting dose 4.0 - 5.1 mg/kg/day until clinical improvement. Upon clinical improvement, cyclosporin dose to be tapered by 50% every two weeks.
16240710|NCT01079988|Drug|Retinoids|Starting dose 25 - 50 mg/day until clinical improvement. Upon clinical improvement, retinoid dose to be reduced by 50%. Thereafter, treatment to be continued for 8 weeks and then stopped.
16240711|NCT01079988|Drug|Systemic corticosteroids|Starting dose 0.25 - 0.5 mg/kg/day until clinical improvement. Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, corticosteroids to be weaned by 50% every 2 weeks.
16240712|NCT01079988|Drug|Methotrexate|Starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, methotrexate dose to be reduced by 25% every two weeks.
16240713|NCT01079988|Drug|Systemic corticosteroids/methotrexate|Upon clinical improvement, corticosteroid dose to be reduced by 50%. Thereafter, to be weaned by 50% every 2 weeks. Methotrexate starting dose 20 - 25 mg per week until clinical improvement. Upon clinical improvement, dose to be reduced by 25%. Thereafter, to be reduced by 25% every two weeks.
16240714|NCT01079962|Drug|Bisoprolol|Bisoprolol tablet will be administered orally at a dose of 5 milligram (mg) once daily in the morning for 12 weeks.
16240715|NCT01079962|Drug|Atenolol|Atenolol tablet will be administered orally at a dose of 50 mg once daily in the morning for 12 weeks.
16240716|NCT01079949|Drug|r-hLH + r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection will be administered subcutaneously once daily from stimulation Day 1(S1) at a starting dose of 300-450 International Unit (IU) and then dose adjusted depending on the ovarian response till recombinant human choriogonadotropin (r-hCG) administration day. Recombinant human luteinizing hormone (r-hLH, Luveris®, Lutropin alfa) injection will be administered subcutaneously once daily at a constant dose of 150 IU with flexible start, depending on the follicular growth (when the lead follicle is greater than 14 mm in size), along with r-hFSH treatment as a separate injection till r-hCG administration day.
16240717|NCT01079949|Drug|r-hFSH|Recombinant human follicle stimulating hormone (r-hFSH) injection will be administered subcutaneously once daily from S1 at a starting dose of 300-450 IU and then dose adjusted depending on the ovarian response till r-hCG administration day.
16240718|NCT01079949|Drug|Recombinant Human Choriogonadotropin (r-hCG)|The r-hCG will be administered as a single dose of 250-500 microgram (mcg) subcutaneously in the same day after the last dose of the GnRH antagonist.
16240719|NCT01079949|Drug|GnRH antagonist|The GnRH antagonist will be administered at a starting at a dose of 0.25 milligram (mg) subcutaneously daily in the morning when the ultrasound discovers a follicle of greater than or equal to (>=) 14 mm, and maintained until at least one follicle of >=18 mm and two additional follicles of >=16 mm with appropriate plasma estradiol levels for the number and size of the existing follicles.
16240720|NCT01079936|Drug|Lenalidomide|Beginning dose level 25 mg by mouth (PO) on Days -8 to -2
16240721|NCT01079936|Drug|Melphalan|Dose level 100 mg/m2 by vein (IV) Days -3 and -2 over 30 minutes infusion
16240722|NCT01079936|Procedure|Stem Cell Infusion|Stem cell infusion on Day 0.
16240723|NCT01079923|Dietary Supplement|Single High Dose Cholecalciferol|Age 18 to 40 years, non-pregnant, non-lactating, female subjects will receive cholecalciferol 150,000 international units orally once (Bio-tech Pharmacal 50,000 IU capsule, Fayetteville, AR).
16240724|NCT01079923|Dietary Supplement|Daily Dose Cholecalciferol|Age 18 to 40 years, non-pregnant, non-lactating, female subjects will receive cholecalciferol 5,000 IU capsule, Fayetteville, AR).
16240725|NCT01079910|Drug|isopropylmethylphenol and Fluoride|0.1% isopropylmethylphenol and 1150ppm fluoride
16240726|NCT01079910|Drug|Fluoride and Silica|NaF/Silica toothpaste containing 1150ppm fluoride
16240727|NCT01079897|Device|Atopiclair|topical applied cream, twice daily
16240728|NCT01079897|Device|EHK02-01|topical applied cream containing 7% ectoine
16240729|NCT01079884|Drug|esomeprazole 40 mg|40 mg daily for 4 weeks
16240730|NCT01079871|Other|FID 114657 (ORB Preserved Ocular Emulsion)|Patients will dose as needed throughout the day (PRN) for 4 weeks.
16240731|NCT01079858|Other|FID 114657 (ORB Preserved Ocular Emulsion)|Patients will dose as needed throughout the day (PRN) for 4 weeks.
16240732|NCT01079845|Behavioral|Nutrition Education, Dietary Counseling, and Cooking|Monthly clinic visits with a dietitian, Monthly telephone calls with a dietitian, Three cooking workshops with a chef
16240733|NCT01079832|Radiation|stereotactic radiosurgery|Radiation will be delivered in 3 fractions. The dose level will range between 500 to 800cGy per fraction at the discretion of the treating radiation oncologist
16240734|NCT01079832|Procedure|quality-of-life assessment|Ancillary studies
16240735|NCT01079819|Drug|BMS-708163|Capsule, Oral, 50 mg, once daily, 1 Day
16240736|NCT01079819|Drug|BMS-708163|Capsule, Oral, 125 mg, once daily, 14 Days
16240737|NCT01079819|Drug|Placebo|Capsule, Oral, 0 mg, One daily, 1 Day
16240738|NCT01079819|Drug|Placebo|Capsule, Oral, 0 mg, One daily, 14 Day
16240739|NCT01079806|Drug|Entecavir|Tablets/oral solution, 0.015 mg/kg up to 0.5 mg, administered orally, once daily, for 96 to144 weeks, depending on response
16241387|NCT01074359|Drug|Placebo|28 days of placebo oral capsules. Treatment taken twice daily with meals.
16240740|NCT01079806|Drug|Placebo|Tablets/oral solution, 0 mg, administered orally, once daily, for 48 to 96 weeks, depending on response
16240741|NCT01079793|Drug|ixabepilone|
16240742|NCT01079793|Procedure|adjuvant therapy|
16240743|NCT01079793|Radiation|intensity-modulated radiation therapy|
16240744|NCT01079780|Biological|cetuximab|Given IV
16240745|NCT01079780|Biological|ramucirumab|Given IV
16240746|NCT01079780|Drug|irinotecan hydrochloride|Given IV
16240747|NCT01079767|Drug|temsirolimus|
16240748|NCT01079754|Drug|Spinal morphine 0.05 mg|Patient received spinal morphine 0.05 mg
16240749|NCT01079754|Drug|Spinal morphine 0.1 mg|Patient received spinal morphine 0.1 mg
16240750|NCT01079741|Biological|NY-ESO-1 protein; Poly-ICLC; Montanide|"Phase I represents the dose-escalation component with Poly-ICLC given in combination with NY-ESO-1 and Montanide in an open-label fashion. The dose of Poly-ICLC will be increased stepwise from 0.35mg to 1.4mg while the dose of NY-ESO-1 antigen (100µg) and Montanide (1.1mL) will be held constant.
~Phase II: The doses of NY-ESO-1 and Montanide will remain the same as in Phase I; the highest tolerated Phase I dose of Poly-ICLC will become the Phase II Poly-ICLC dose. In Phase II, patients will be randomized to a subcutaneous vaccination of NY-ESO-1 protein with Poly-ICLC alone dose TBD (Arm A) or with NY-ESO-1 protein, Poly-ICLC dose TBD and Montanide (Arm B)."
16240751|NCT01079715|Drug|Propranolol|"Dosage of 0.5mg/Kg oral, every 6 hours. The study will be discontinued immediately in the presence of serious adverse effects attributable to the pharmacological actions of propranolol (severe hypotension, bradycardia or bronchospasm).
~In case such events occur in any of the 3 groups of gestational age, the study could start again with half dose (0.25mg/Kg oral, every 6 hours) after notification to the Ethics Committee.
~In case of surgery or induction of anesthesia during the administration of propranolol, the drug should be discontinued at least 24 hours before surgery.
~In cases of severe hypotension or bradycardia may be administered one or more of the following drugs:
~Atropine.
~Isoproterenol hydrochloride (isoprenaline.
~Terlipressin.
~Glucagon In case of severe bronchospasm may be used salbutamol aerosol or salbutamol + ipratropium bromide. Betamethasone could be used for aerosol or systemic (intravenous or intramuscular)."
16240752|NCT01079702|Drug|Everolimus|Everolimus, administrated twice daily at a fixed total dose of 10 mg continuously.
16240753|NCT01079702|Drug|Capecitabine|Capecitabine administered bid for 14 days followed by 7 days rest. In this study, capecitabine will be dose escalated. The first dose level of capecitabine is 500 mg/m2 twice daily.
16240754|NCT01079689|Other|needle stimulation|stimulation with acupuncture needles
16240755|NCT01079676|Drug|Filgrastim (Eurofarma)|Filgrastim will be given at the daily dose of 5 µg/kg body weight, subcutaneously. The weight considered will be the actual weight, for patients weighing up to 120 kg.
16240756|NCT01079676|Drug|Filgrastim (Granulokine, Amgen)|Granulokine will be given at the daily dose of 5 µg/kg body weight, subcutaneously. The weight considered will be the actual weight, for patients weighing up to 120 kg.
16240757|NCT01079663|Drug|Chlorhexidine 2.5 mg|
16240758|NCT01079663|Drug|Placebo chip|
16240759|NCT01079637|Procedure|Surgery with Midfoot Fusion Bolt|Surgery with Midfoot Fusion Bolt
16240760|NCT01079637|Procedure|Cast treatment|Cast treatment
16240761|NCT01079624|Other|Glucose-insulinotropic peptide, Glucagon-like peptide-1|GIP 2 and 5 pmol/kg min GLP-1 0.7 pmol/kg min
16240762|NCT01079598|Device|RF Ablation (ClosureRFS Stylet)|Bipolar energy radiofrequency ablation with RFS stylet
16240763|NCT01079585|Dietary Supplement|Nutrigal Okara - 100|
16240764|NCT01079572|Other|in-person|Follow-up appointments will be completed in-person as per usual
16240765|NCT01079572|Other|web-based|Patients who are at least 2 years following knee or hip replacement will complete a questionnaire online and routine x-rays at a PACS enabled imaging center. The patient's surgeon will receive an email from the database summarizing the patient's responses to key questions and will review the x-rays. The surgeon will determine whether the patient needs to be seen in-person.
16240766|NCT01079559|Device|Simplex™ P with Tobramycin|All patients will receive preoperative antibiotics administered within the hour prior to surgery.All patients will undergo a cemented total knee replacement (both femoral and tibial components) with the type of implant left to the discretion of the surgeon. The patella may or may not be resurfaced depending on indication and preference. All patients will receive one of the two study cements (Simplex™ P with Tobramycin or Simplex™ P) in a blinded fashion; all cement vials will be similar in size and shape and the cement will be similar in odour, color and texture. No additional antibiotics will be added to the cement. Surgeons can use their preferred cement preparation technique (i.e. manual or vacuum mixing). The use of a suction drain will depend on surgical indication and preference.
16240767|NCT01079559|Device|Simplex™ P|All patients will receive preoperative antibiotics administered within the hour prior to surgery.All patients will undergo a cemented total knee replacement (both femoral and tibial components) with the type of implant left to the discretion of the surgeon. The patella may or may not be resurfaced depending on indication and preference. All patients will receive one of the two study cements (Simplex™ P with Tobramycin or Simplex™ P) in a blinded fashion; all cement vials will be similar in size and shape and the cement will be similar in odour, color and texture. No additional antibiotics will be added to the cement. Surgeons can use their preferred cement preparation technique (i.e. manual or vacuum mixing). The use of a suction drain will depend on surgical indication and preference.
16240768|NCT01079533|Behavioral|Stepped CRCS Interventions|"In Step 1, we will evaluate a theory-based minimal cue delivered by a letter, telephone call, or automated telephone call. Persons who do not complete CRCS in Step 1 will be randomized to Step 2 using principles of Motivation Interviewing. Step 2 also will determine whether an automated approach, telephone-linked communication (TLC), is as effective as a telephone counselor in promoting initiation of CRCS. Steps 1 and 2 together will address the important issue of the dose needed to encourage completion of CRCS."
16240769|NCT01079533|Behavioral|Control|A survey-only control arm will be compared to the experimental arm to determine whether the 3 different delivery channels are equally efficacious and cost-effective.
16240770|NCT01079520|Procedure|Endobronchial ultrasound (EBUS)|Minimally invasive technique to stage lung cancers
16240771|NCT01079520|Procedure|Mediastinoscopy|Traditional surgical method to stage lung cancers
16240772|NCT01079494|Other|pharmaceutical care services|Patients treatment related problems and therapeutic needs or complains identified by clinical pharmacist and managed collaboratively by both pharmacist and the physician.
16240773|NCT01079481|Drug|taxol plus everolimus|taxol 175mg/m2 every 3 weeks plus everolimus every day. The dose of everolimus will be started from 2.5mg per day, and increasing to 5mg per day and to 10mg per day.
16240774|NCT01079455|Drug|Corticosterone|Hyaluronic acid 40 mg / 2 ml Corticosteroids 80 mg / 2 ml Bupivacaine 0.125% / 2 ml
16240775|NCT01079442|Other|Postoperative coffee|"schedule for coffee administration for the present trial was chosen as follows (starting 6 hours postoperatively):
~08:00 100mL beverage
~12:00 100mL beverage
~16:00 100mL beverage"
16240776|NCT01079442|Other|water|"The control drink consists of 100 ml warm water which is administered according a same fixed schedule as Group A starting 6 hours postoperatively:
~08:00 100mL beverage
~12:00 100mL beverage
~16:00 100mL beverage"
16240777|NCT01079429|Genetic|Genetic study of DNA copies|Gene expression profiling, DNA copy number variation
16240778|NCT01079416|Device|Capsule endoscopy, Esophagogastroduodenoscopy|
16240779|NCT01079390|Device|acupuncture|patient will receive high dose, low dose or sham acupuncture treatment.
16240780|NCT01079364|Drug|Insulin glulisine|Pharmaceutical form: boxes of 5 SoloStar® pens Route of administration: injection Dose regimen: once a day
16240781|NCT01079364|Drug|Insulin glargine|Pharmaceutical form: boxes of 5 SoloStar® pens Route of administration: injection Dose regimen: once a day
16240782|NCT01079364|Drug|Premixed insulin (Insulin Aspart 30/70 )|Pharmaceutical form:boxes of 5 FlexPens Route of administration: Injection Dose regimen: twice daily
16240783|NCT01079351|Drug|Intravenous Carbamazepine|10 mg/mL of intravenous Carbamazepine (CBZ) dissolved in 250 mg/mL of Captisol® (cyclodextrin) dosed at 70% of the patient's daily maintenance dose of oral CBZ administered after suitable dilution with D5W by intravenous infusion every 6 hours.
16240784|NCT01079338|Other|caffeine|
16240785|NCT01079325|Drug|SB-509|SB-509 60 mg, 3 treatments, and 5 months treatment period
16240786|NCT01079325|Other|Saline|
16240787|NCT01079312|Device|infusion pump|anaesthesiologist´s managed infusion of propofol 10 mg/ml at rate of 10-60ml/h during ERCP targeting to moderate sedation level
16240788|NCT01079312|Device|infusion pump for patient-controlled sedation|self-administration of propofol and remifentanil mixture with zero lockout time and without dose limit and background infusion via Arcomed,Syramed AG,Switzerland self-administration pump.
16240789|NCT01079312|Drug|propofol|Propofol 10 mg/ml solution is a short-acting, intravenously administered hypnotic agent.In propofol infusion group moderate sedation was initiated with propofol 40 mg bolus,thereafter propofol infusion was started at rate of 0.5 mg/kg/h.If the performance of ERCP become difficult infusion rate was increased gradually ad maximum rate of 9 mg/kg/h.Additional propofol boluses of 20-40 mg were available in both groups due to an anaesthesiollogist´s ´desigion.In patient-controlled sedation group propofol was used for preparation of sedative mixture.
16240790|NCT01079312|Drug|fentanyl|Fentanyl citrate 50 mcg/ml,solution for injection,is a narcotic analgesic.In propofol infusion group 0.05 mg of fentanyl was administered intravenously before initiation of sedation. Additional 0.05 mg boluses of fentanyl were given if nociceptive stimulus was anticipated.
16240791|NCT01079312|Drug|sedative mixture|Sedative mixture was prepared by adding 5 ml of remifentanil hydrochlorid solution (50 mcg/ml)to 20 ml of propofol (10 mg/ml)
16240792|NCT01079312|Drug|remifentanil hydrochlorid|Solution of remifentanil hydrochlorid (50 mcg/ml) was used for preparation of sedative mixture(see sedative mixture for details)
16240793|NCT01079299|Device|Intermittent, gradient, pneumatic compression device|lymphedema pump provides external compression in a segmental,gradient fashion
16240794|NCT01079286|Drug|Nelfinavir and temsirolimus|Nelfinavir tablets of 250mg given twice daily in an escalating dosis schedule, Temsirolimus i.v. given weekly in an escalating dosis schedule
16240795|NCT01079273|Biological|egg-derived A/H1N1 pandemic influenza vaccine|One 0.50 mL IM dose injection (7.5 µg of vaccine + 9.75 mg MF59)
16240796|NCT01079260|Dietary Supplement|Standard ONS|Standard ONS
16240797|NCT01079260|Dietary Supplement|High Energy, low volume ONS|High energy, low volume ONS
16240798|NCT01079247|Other|Restrictive transfusion threshold|maintain hemoglobin at 7-8 g/dL
16240799|NCT01079247|Other|Liberal transfusion threshold|Maintain hemoglobin at 10-11 g/dL
16240800|NCT01079234|Drug|insulin degludec|Injected subcutaneously (under the skin) once daily
16240801|NCT01079234|Drug|insulin glargine|Insulin glargine injected subcutaneously (under the skin) once daily
16240802|NCT01079234|Drug|insulin aspart|At least three daily doses at meal-time
16240803|NCT01079221|Behavioral|High intensity knee-extensor training|High intensity aerobic knee-extensor exercise training, 4x 3 minutes interval training at < 90 % of peak power, 3 days/week for 6 weeks
16240804|NCT01079208|Other|test starter infant formula|infants are fed for 6 months with this starter formula
16240805|NCT01079208|Other|test starter infant formula with synbiotics|infant are fed for 6 months with this formula
16240806|NCT01079208|Other|control standard formula|infant are fed 6 months with this formula
16240807|NCT01079169|Dietary Supplement|Cranberry capsules|Cranberry capsules, 550mg, or placebo capsules, two capsules three times daily during in-patient rehabilitation
16240808|NCT01079143|Drug|Certican®|Certican® was supplied to the participating centers by Novartis for the whole duration of the study in the form of tablets containing 0.75, 0.5 and 0.25 mg and packaged in blister packs.
16240809|NCT01079143|Drug|Neoral|Neoral® was also supplied to participating centers for the entire duration of the study in the form of soft capsules of 10 mg, 25 mg, 50 mg and 100 mg, and packaged in blister packs.
16240810|NCT01079143|Drug|Myfortic|"Myfortic ® was supplied to the participating centers for the duration of the study in the form of 180 and 360 mg gastro-resistant, film-coated tablets. Myfortic® treatment was provided to patients preoperatively or within 24 hours post-transplantation according to the practices of the center. The starting dose was generally 1,440 mg/day, in 2 daily oral fractions, administered at 12 hour intervals up to randomization. Depending on the practices of the center and for the first 6 weeks post-transplantation, a maximum daily dose of 2160 mg of Myfortic® could be administered. In the Neoral® group, the daily dose of 1440 mg was maintained throughout the study.
~In the Certican® group, the dose was halved (i.e. 720 mg/day) on introducing Certican® and maintained at 720 mg/day until the end of the study.
~An increase in the daily dose of Myfortic® (in the Certican® group) was not authorized unless this was a temporary increase that did not exceed a period of 14 consecutive days."
16240811|NCT01079143|Drug|Simulect®|The administration of Simulect® was part of the standard immunosuppressant therapy. This induction therapy was provided to patients in the form of commercial ampoules each containing 20 mg. Simulect® was administered to each patient at the dose of 20 mg on D0 and D4 post-transplantation.
16240812|NCT01079143|Drug|Corticosteroids|An intravenous steroid treatment could be administered peri or intraoperatively according to local practice at each center. Oral steroid treatment was quickly introduced (in the week following transplantation) at a daily dose of 20 mg and was then reduced and continued throughout the study at a minimum dose of 5 mg/day.
16240813|NCT01079130|Drug|Indacaterol|Once daily via Concept1, a single-dose dry powder inhaler (SDDPI) for two week. Dosage varies according to randomization scheme.
16240814|NCT01079130|Drug|Salmeterol|50 µg Salmeterol twice daily in the morning and in the evening via Diskus®, a MDDPI for 2 weeks.
16240815|NCT01079130|Drug|Placebo to Indacaterol|Placebo to Indacaterol once daily in the morning via Concept 1, a SDDPI.
16240816|NCT01079130|Drug|Placebo to Salmeterol|Placebo to Salmeterol twice daily in the morning and in the evening via Diskus®, a multi-dose dry powder inhaler (MDDPI).
16240817|NCT01079117|Drug|Sevre-Long™|The subjects will be randomised to either 10 weeks of treatment with methadone or SROM. After an adjustment phase of one week they first will be medicated for 10 weeks with the treatment to which they have been randomised. The cross-over, in which all subjects change to their opposite treatment, will serve for an additional adjustment phase of one week. After the second and new adjustment phase they are treated for 10 weeks with the newly adjusted medication. After the end of week 22 all participants continue with or switch back to SROM for another 6 month (week 23 to 47).
16240818|NCT01079117|Drug|Slow release oral morphine|
16240819|NCT01079117|Drug|Methadone|
16240820|NCT01079104|Device|Hepa Wash|"Intervention frequency: 1-10 treatments (decision of the investigator)
~Duration of intervention per patient: Treatment until recovery or death (max. 6 weeks)"
16240821|NCT01079104|Procedure|Standard Medical Therapy|Standard of care treatment
16240822|NCT01079091|Device|ADVOS (Hepa Wash)|"Intervention frequency: 1-10 treatments (decision of the investigator)
~Duration of intervention per patient: Treatment until recovery or death (max. 6 weeks)"
16240823|NCT01079091|Procedure|Standard Medical Therapy|Standard of care treatment
16240824|NCT01079078|Drug|Acetaminophen|
16240825|NCT01079065|Drug|Famotidine|Tablets
16240826|NCT01079052|Drug|Famotidine|Tablets
16240827|NCT01079013|Drug|treosulfan|12 g/m2 x 3 days
16240828|NCT01079000|Behavioral|Opinion Leader letter|The patients' PCP will be notified by fax about the ED visit and management. The Opinion Leader letter will contain a summary of the current asthma guidelines for ambulatory care (including: asthma education, long-term recommendations, smoking cessation, and action plan) signed by a local opinion leader. A review of the patient's management within a week of the ED visit will be recommended. The patient will also receive information regarding their acute exacerbation and will be told to review the current management of their disease with their PCP.
16240829|NCT01079000|Behavioral|Involvement of a care manager|The involvement of a care manager will encourage patients' to pursue follow-up, provide management review and offer brief education via telephone within a week of being discharged
16240830|NCT01079000|Behavioral|Usual care|Usual care provided to asthma patients when discharged from the ED
16240831|NCT01078987|Procedure|Plasmapheresis|A course of 5 daily treatments of plasma exchange (plasmapheresis) for one to three courses
16240832|NCT01078974|Drug|pomalidomide|Taken orally once a day
16240833|NCT01078974|Drug|dexamethasone|Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15
16240834|NCT01078974|Drug|rituximab|Given intravenously on weeks 1, 2, 3 and 4 and weeks 12, 13, 14 and 15
16240835|NCT01078961|Drug|bortezomib|Given intravenously on days 1, 8 and 15 of each 28 day cycle
16240836|NCT01078961|Drug|sorafenib|400mg taken orally twice a day
16240837|NCT01078948|Device|transcranial direct current stimulation (tDCS)|Delivery of mild current to specified brain regions.
16240838|NCT01078935|Dietary Supplement|probiotics|Each patient and volunteer will get the study medication for 6 weeks and will be evaluated twice - before enrollment and after 6 weeks of treatment. Routine clinical management will continue - with regular treatment as needed.
16240839|NCT01078935|Dietary Supplement|placebo|Each patient and volunteer will get the study medication for 6 weeks and will be evaluated twice - before enrollment and after 6 weeks of treatment. Routine clinical management will continue - with regular treatment as needed.
16240840|NCT01078922|Drug|Ofatumumab|The first dose administered of ofatumumab should be 300 mg to minimize infusion reactions. The initial rate of the first infusion of 1000 mg ofatumumab (0.3mg/ml) should be 12ml/h. If no infusion reactions occur the infusion rate should be increased every 30 minutes, to a maximum of 400 ml/h. If this schedule is followed, the infusion duration will be approximately 4.5 hours.
16240841|NCT01078909|Biological|Eicosapentaenoic Acid and Docosahexaenoic Acid (EPA + DHA)|Comparison of 4 doses of EPA+DHA on in vivo and ex vivo (monocytes) response to an inflammatory stimulus (endotoxin) following a 6 month supplementation period
16240842|NCT01078870|Drug|Lexapro|10mg/cap 1~2# QD
16240843|NCT01078870|Drug|Cymbalta|30mg/cap 30~60mg/QD
16240844|NCT01078870|Drug|Placebo|1~2#/cap QD
16240845|NCT01078857|Other|Skin biopsy|A 3-mm-diameter skin biopsy punch was taken at the lateral side of the distal leg and fixed in 4% paraformaldehyde overnight. Sections of 50 m perpendicular to the dermis were cut on a sliding microtome, quenched with 1% H2O2 in methanol, and blocked with 5% normal goat serum. Sections were incubated with rabbit antiserum to protein gene product 9.5 (PGP 9.5, UltraClone, Isle of Wight, UK, 1:1000) overnight. PGP 9.5 is a ubiquitin carboxyl hydrolase, which labels myelinated and unmyelinated nerve fibers in the peripheral nervous system. Sections were then incubated with biotinylated goat anti-rabbit immunoglobulin G (Vector, Burlingame, CA) for 1 h and the avidin-biotin complex (Vector) for another hour. The reaction product was demonstrated using chromogen SG (Vector).
16240846|NCT01078844|Drug|memantine|memantine 5-20 mg daily
16240847|NCT01078844|Drug|Placebo|Look-alike placebo
16240848|NCT01078831|Other|Bronchoscopy|Airway pressures, ventilation changes and blood gas changes are recorded in a group of intubated patients on mechanical ventilation before and after bronchoscope insertion. The registration is done immediately before a therapeutic/diagnostic bronchoscopy requested by a staff physician not involved n the study.
16240849|NCT01078818|Drug|IV trivalent saccharose hydroxide ferrous|"Preoperative Period 5-10 days 200 mg Iron iv (Venofer® )in 200cc physiologic solution /24-48h x 3 dosis +1 oral placebo /24h Postoperative Period 1-3weeks 200 mg Iron iv (Venofer® )in 200cc physiologic solution/24-48h x 3 dosis + 1 oral placebo /24h One month Follow-up
~1 month 1 oral placebo /24h"
16240850|NCT01078818|Drug|Oral ferrous fumarate|"200cc physiologic solution iv placebo /24-48h x 3 dosis + 1 oral iron tablet/24h (Ferogradumet®)
~Postoperative Period:
~200cc physiologic solution iv placebo /24-48h x 3 dosis + 1 oral iron tablet/24h (Ferogradumet®) One month Follow-up: 1 oral iron tablet/24h Ferogradumet"
16240851|NCT01078818|Drug|Oral and intravenous Placebo|Preoperative Period:1oral placebo/24h Postoperative Period:200cc physiologic solution iv placebo /24-48h x 3 dosis + 1oral placebo/24h One month Follow-up:1 oral placebo/24h
16240852|NCT01078805|Drug|FORTEO|prescribed in accordance with usual clinical practice for up to 24 months
16240853|NCT01078792|Other|CT pulmonary angio, blood tests|
16240854|NCT01078779|Drug|Chloroquine|Chloroquine phosphate 250mg capsule, two capsules daily for 7 days then 2 capsules once a week for a total treatment duration of 12 weeks
16240855|NCT01078779|Drug|Placebo|Placebo capsules, 2 capsules daily for 7 days then 2 capsules weekly for a total treatment duration of 12 weeks
16240856|NCT01078766|Other|CIMT+HABIT|The daily schedule included one hour of constraining the functional arm with intensive activation of the hemi-paretic arm and then 5 hours of various structured, intensive bimanual functional activities,
16240857|NCT01078753|Drug|Desmopressin|Desmopressin oral lyophilisate tablet, 120 μg or 240 μg, administered sublingually once a day 1½ hours before bedtime.
16240858|NCT01078753|Drug|Placebo|Placebo oral lyophilisate tablet was administered sublingually once a day 1½ hours before bedtime.
16240859|NCT01078727|Device|A custom-made constant temperature thermal stimulation system (FIRSTEK, Model-B401L, B-300, local company, Taiwan).|The subjects meeting our criteria will be randomly assigned to either the experimental group or the control group. First stage (3 months after onset), the subjects in the experimental group will receive an upper extremity Thermal Stimulation (TS) protocol for 30 minutes (3 times a week for 8 weeks). The subjects in the control group will receive a lower extremity TS protocol.
16240860|NCT01078714|Drug|bumetanide|Administration by oral route in 2 times (in the morning and evening) of 0.5 mg by taking (= 1 mg by 24 hours)
16240861|NCT01078701|Biological|GHB11L1|GHB11L1 administration by liquid nasal spray at doses of 6.0 log10, 6.5 log10 and 7.0 log10 TCID50/volunteer
16240862|NCT01078701|Biological|Placebo|SPGN buffer
16240863|NCT01078675|Drug|rosuvastatin calcium|5 mg, oral, once daily, 24 months
16240864|NCT01078675|Drug|rosuvastatin calcium|10 mg, oral, once daily, 24 months
16240865|NCT01078675|Drug|rosuvastatin calcium|20 mg, oral, once daily, 24 months
16240866|NCT01078662|Drug|olaparib|400mg (8 x 50mg capsules), oral BID until progression of the disease
16240867|NCT01078649|Drug|Debio 1143 (AT-406)|Oral Debio 1143 (AT-406) will be administered in a dose escalation study to determine the maximally tolerated dose in humans. Patients will receive Debio 1143 (AT-406) on days 1-5, and 15-19 of a 28 day cycle, or days 1-5 of a 21 day cycle, repeated until progression or unacceptable toxicity occurs.
16240868|NCT01078623|Drug|Aclidinium 200 μg / formoterol 12 μg|Aclidinium bromide 200 μg + formoterol fumarate 12 μg fixed dose combination (FDC) twice daily
16240869|NCT01078623|Drug|Placebo|Placebo control twice daily
16240870|NCT01078623|Drug|Formoterol 12 μg|Formoterol fumarate 12 μg twice daily
16240871|NCT01078623|Drug|Aclidinium 200 μg|Aclidinium bromide 200 μg twice daily
16240872|NCT01078623|Drug|Aclidinium 200 μg / Formoterol 6 μg|Aclidinium bromide 200 μg + formoterol fumarate 6 μg fixed dose combination (FDC) twice daily
16240873|NCT01078610|Biological|adalimumab (Humira)|40 mg adalimumab (Humira) every other week.
16240874|NCT01078571|Biological|adalimumab (HUMIRA®)|The primary objective of the study is to evaluate the safety and tolerability of adalimumab (HUMIRA®) treatment, administered both in monotherapy and combined therapy, in rheumatoid arthritis (RA) patients under usual practice conditions.
16240875|NCT01078545|Drug|Leuprolide acetate Depot Susp. 11.25 mg (Poland), 3.75 mg (Ukraine)|Leuprolide acetate 11.25 mg every 3 months sc or im, number of injections during the trial - 5 in Poland, Leuprolide acetate 3.75 mg every 1 month sc or im, number of injections during the trial - 12 in Ukraine.
16240876|NCT01078532|Other|SMART PHR|Patient receives an active PHR
16240877|NCT01078532|Other|usual care|Usual passive PHR
16240878|NCT01078519|Drug|Combined epidural and spinal anesthesia|Obstetrics patients will relieve spinal anesthesia with local anesthesics and opioids associated with epidural anesthesia with local anesthetics in low concentrations with opioids
16240879|NCT01078493|Device|MyCells® (injection of platelet rich plasma)|PRP contains at least 1,000,000 platelets per mm3 or 2-6 times the native concentration of whole blood at a pH of 6.5 to 6.7
16240880|NCT01078480|Procedure|Operation using a precontoured titanium plate and screws|Operation using a precontoured titanium plate and screws
16240881|NCT01078480|Procedure|Displaced midshaft fracture of the collar bone|Displaced midshaft fracture of the collar bone treated with an arm sling
16240882|NCT01078454|Drug|melphalan|Given PO
16240883|NCT01078454|Drug|dexamethasone|Given PO
16240884|NCT01078454|Drug|bortezomib|Given IV
16240885|NCT01078441|Drug|liposomal doxorubicin|Given IV
16240886|NCT01078441|Drug|bortezomib|Given subcutaneously.
16240887|NCT01078441|Drug|dexamethasone|Given orally
16240888|NCT01078441|Drug|cyclophosphamide|Given IV
16240889|NCT01078428|Other|Topical silicone gel|Topical silicone gel will be applied to the scar twice daily for a period of 8 weeks
16240890|NCT01078428|Other|Vaseline|Topical petrolatum gel will be applied to the scar twice daily for a period of 8 weeks
16240891|NCT01078415|Device|Ablation with the NanoKnife Low Energy Direct Current (LEDC) System|90 pulses of 70 microseconds each in duration will be administered per electrode pair.
16240892|NCT01078389|Drug|Febuxostat|Febuxostat capsules
16240893|NCT01078389|Drug|Placebo for Febuxostat|Febuxostat placebo-matching capsules
16240894|NCT01078376|Drug|Azilsartan medoxomil (TAK-491)|Azilsartan medoxomil 80 mg, tablets, orally, one day only
16240895|NCT01078376|Drug|Azilsartan medoxomil (TAK-491)|Azilsartan medoxomil 20 mg to 60 mg (based on participant weight), tablets, orally, one day only
16240896|NCT01078376|Drug|Azilsartan medoxomil (TAK-491)|Azilsartan medoxomil 20 mg to 60 mg (based on participant weight), tablets, orally, one day only
16240897|NCT01078376|Drug|Azilsartan medoxomil (TAK-491)|Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
16240898|NCT01078363|Drug|ramipril|Use of a ACE ( angiotension converting enzyme) inhibitors post heart Transplant for Blood pressure control.
16240899|NCT01078363|Drug|Placebo|Use of a placebo post heart Transplant for Blood pressure control.
16240900|NCT01078350|Procedure|tumor tissue aspiration|
16240901|NCT01078350|Procedure|phlebotomy|
16240902|NCT01078337|Procedure|bone marrow aspiration|
16240903|NCT01078337|Procedure|peripheral blood sampling|
16240904|NCT01078298|Drug|varenicline|varenicline tablets titrated to 1 mg BID during 1st week and then 1 mg BID for 11 weeks
16240905|NCT01078298|Drug|placebo|placebo tablets matched in appearance and dosage to varenicline tablets
16240906|NCT01078285|Behavioral|No Patient Counseling|Patients do not receive any adherence counseling, or other patient support services
16240907|NCT01078285|Behavioral|Adherence Counseling|Patients receive 3-5 minutes of adherence counseling, and other patient support services
16240908|NCT01078272|Other|Remote ischemic preconditioning|Randomized subjects are treated immediately prior to stenting with remote ischemic preconditioning consisting of 3 5 minute blood pressure cuff inflations to occlude the brachial artery in their nondominant arms, with intervening 5 minute rest periods.
16240909|NCT01078272|Other|Sham Remote Ischemic Preconditioning|Randomized subjects who are exposed immediately prior to stenting to sham remote ischemic preconditioning consisting of 3 5 minute blood pressure cuff placements without inflation on their nondominant arms, with intervening 5 minute rest periods.
16240910|NCT01078194|Device|Secondary Bypass Banding (adjustable A.M.I. Soft Gastric Band)|Secondary Placement of the A.M.I. Soft Gastric Band for laparoscopic bypass banding
16240911|NCT01078181|Procedure|gastric bypass|laparoscopic gastric bypass with circular stapled 21mm gastrojejunostomy
16240912|NCT01078168|Drug|Acitretin|30mg per day from Day 1 to Day 28
16240913|NCT01078168|Drug|Placebo|Placebo
16240914|NCT01078142|Drug|Temsirolimus, Rituximab, Bendamustin|"Phase I:
~Temsirolimus 25 - 50 - 75mg, day 1,8,15 Bendamustin 90/m2, day 1,2 Rituximab 375/m2, day 1 Phase II at established dose, repeat day 28-42 (max)"
16240915|NCT01078129|Behavioral|cognitive remediation therapy|program consisting of 14 training sessions of 4 cognitive functions (attention/concentration, topological memory, logical reasoning, executive functions)by means REHACOM® software
16240916|NCT01078129|Behavioral|non-CRT|waiting list
16240917|NCT01078051|Procedure|Cypher, xience, Endeavor, Taxus|all species of drug-eluting stent implantation
16240918|NCT01078051|Drug|optimal medical therapy|optimal medical therapy
16240919|NCT01078038|Device|Cypher|Sirolimus-eluting stent implantation
16240920|NCT01078038|Device|Xience V|Everolimus-eluting Stent implantation
16240921|NCT01078025|Procedure|Smear test vaginally, intraabdominally|Pre- and intraoperative smear tests of the vagina and douglas are performed.
16240922|NCT01078025|Procedure|Smear test vaginally, intraabdominally|Pre- and intraoperative smear tests of the vagina and douglas are performed.
16240923|NCT01078012|Behavioral|Trained counselling|
16240924|NCT01077999|Drug|Carboplatin|Carboplatin AUC = 2 , weekly.
16240925|NCT01077999|Drug|Paclitaxel|Paclitaxel 50 mg/m2, weekly
16240926|NCT01077999|Drug|panitumumab|panitumumab: 6mg/kg in weeks 1-3-5.
16240927|NCT01077999|Radiation|radiotherapy|A total dose of 41.4 Gy will be given in 23 fractions of 1.8 Gy.
16240928|NCT01077986|Drug|Capecitabine|Capecitabine will be administered for 14 days in a 3 weekly cycle, starting on day 8.
16240929|NCT01077986|Drug|Cetuximab|Cetuximab will be administered weekly, starting at day 8.
16240930|NCT01077986|Drug|Everolimus|Everolimus will be administered daily, starting on day 1.
16240931|NCT01077973|Drug|Novel Ibuprofen|Single-dose of novel ibuprofen (equal to 400 mg ibuprofen) plus placebo
16240932|NCT01077973|Drug|Standard Ibuprofen|Single-dose of standard ibuprofen (400mg) plus placebo
16240933|NCT01077973|Drug|Placebo|Single-dose of placebo
16240934|NCT01077960|Biological|Serostim|Serostim® 4 mg daily given for 12 weeks (following a prior 36-week treatment [Serono Study 24380] with Serostim® 4 mg daily given for 12 weeks, followed by 24-weeks of either Serostim® 2 mg every other day or Placebo every other day)
16240935|NCT01077947|Procedure|Functional anesthetic discography|Functional anesthetic discography will be performed to diagnose discogenic pain and to correctly identify the disc levels for the surgical treatment. Proper identification for disc levels should improve the overall results of surgery for this condition.
16240936|NCT01077947|Procedure|Provocative Discography|Provocative Discography will be performed to diagnose discogenic pain and to correctly identify the disc levels for the surgical treatment. Proper identification for disc levels should improve the overall results of surgery for this condition.
16240937|NCT01077934|Device|near-infrared spectroscopy|Non-invasive monitoring device applied on the surface of the skin that emits harmless red light to measure tissue perfusion.
16240938|NCT01077921|Drug|Propranolol|Treatment will be with a standard propranolol dose of 40 mg every 12 hrs.Each patient will participate in 6 weeks of treatment with placebo or study drug (propranolol), followed by a 2-week wash-out period and then 6 weeks of treatment with the other modality (placebo or propranolol).
16240939|NCT01077921|Drug|Placebo|Treatment will be with a standard propranolol dose of 40 mg every 12 hrs.Each patient will participate in 6 weeks of treatment with placebo or study drug (propranolol), followed by a 2-week wash-out period and then 6 weeks of treatment with the other modality (placebo or propranolol).
16240940|NCT01077908|Biological|Adoptive Cellular Therapy|CMV-specific T-cells, single infusion at 27 days post-HSCT
16240941|NCT01077908|Drug|Best available antiviral drug therapy|"Intravenous ganciclovir 5mg/kg twice daily
~Oral valganciclovir 900mg twice daily
~Intravenous foscarnet 90 mg/kg twice daily"
16240986|NCT01077596|Drug|Regular bupropion use|Regular use of bupropion is defined as use at least 4 times per week for at least 3 continuous months at least 12 months before index date.
16240987|NCT01077596|Drug|Regular SSRI (Selective serotonin reuptake inhibitors) use|Regular use of SSRI is defined as use at least 4 times per week for at least 3 continuous months at least 12 months before index date.
16240942|NCT01077895|Procedure|CVVH|"CVVH is started using following parameters:
~Blood flow is started at 150 mL/min
~Anticoagulation: none, heparin or low molecular weight heparin according to local protocols in study centers.
~In both groups: dialysis dose of 25 mL/kg body weight administered using both pre- and postdilution
~Substitution fluid temperature is started at 37°C and adjusted in function of patient body temperature (which is maintained at 35-37°C)"
16240943|NCT01077895|Procedure|ultrafiltration|"ultra filtration is started at 100 mL/h and increased according to following protocol
~Ultrafiltration is increased by 100 mL/h after 2h and subsequently by 100mL/h (until a maximum of 500mL/h) every 4h unless:
~Vasopressor or inotrope medication dose is increased by > 25% (provided mean arterial pressure remains constant at 65 mmHg or another target value specified by treating physician according to standard of care)
~When above condition is not met UF should be kept constant and a passive leg raising test or stroke volume variation measurement should be performed. If SVV > 10% or PLR is positive 100mL of albumin 20% solution or 250 mL of Hydroxyethyl Starch 130/0.4 solution is administered according to treating physician at a maximum of 4 times per 24h
~If there is no improvement after 2 colloid administration rounds, UF should be stopped for 4h and restarted at half the rate it was set at when discontinued."
16240944|NCT01077895|Procedure|ultrafiltration control group|ultrafiltration is set at 100 mL/h (and fluid administration is titrated to approach 100 mL /h)
16240945|NCT01077882|Behavioral|education on skin disease conditions|information about several skin diseases skin function recommendation on care of skin
16240946|NCT01077882|Behavioral|Stress-reduction techniques|Physical Training yoga mindfulness-based stress reduction
16240947|NCT01077882|Behavioral|Lifestyle factors and psycho-education|by dietician and psychiatrist
16240948|NCT01077882|Other|no educational program|standard care without educational program
16240949|NCT01077869|Procedure|endoscopic examination|on a weekly basis during 7 weeks
16240950|NCT01077869|Procedure|FDG-PET|once pre-radiotherapy and once 2 weeks after initiation of radiotherapy
16240951|NCT01077843|Drug|Etoricoxib|Cox-2 inhibitor
16240952|NCT01077843|Drug|Other Cox-2 inhibitors|Cox-2 inhibitor
16240953|NCT01077843|Drug|Other Non-selective NSAIDs|Non-selective NSAID
16240954|NCT01077843|Other|No anti-inflammatory treatment|No anti-inflammatory prescription
16240955|NCT01077817|Drug|Alendronate|
16240956|NCT01077817|Drug|Etidronate|
16240957|NCT01077817|Drug|Ibandronate|
16240958|NCT01077817|Drug|Risedronate|
16240959|NCT01077817|Drug|Raloxifene|
16240960|NCT01077791|Behavioral|original cognitive therapy|12 weekly sequences of an original cognitive therapy based on videos involving the learning of a better use of contextual information to infer others' intention. Group of 5 patients trained by 2 therapeutics. Comparison with a non-cognitive psychoeducational training (same organisational design).
16240961|NCT01077778|Procedure|Gadolinium-enhanced Magnetic Resonance Imaging|Gadolinium-enhanced Magnetic Resonance Imaging
16240962|NCT01077765|Device|Eutrophill|Polyacrylamide Hydrogel
16240963|NCT01077752|Drug|continuous ropivacaine preperitoneal infusion|Bolus of 20 mg after the surgery then 20 mg per hour during 48 hours
16240964|NCT01077752|Drug|intravenous lidocaine infusion|Bolus of 60 mg after the surgery then 60 mg per hour during 48 hours
16240965|NCT01077752|Drug|parenteral analgesia combining acetaminophen and morphine|parenteral analgesia combining acetaminophen and morphine
16240966|NCT01077752|Drug|NaCl|NaCl
16240967|NCT01077739|Drug|fluorouracil (5FU)|standard FOLFOX regimen
16240968|NCT01077739|Drug|leucovorin|standard FOLFOX regimen
16240969|NCT01077739|Drug|bevacizumab [Avastin]|7.5 mg/kg iv infusion every 3 weeks OR 5 mg/kg iv infusion every 2 weeks
16240970|NCT01077739|Drug|capecitabine [Xeloda]|standard XELOX regimen
16240971|NCT01077739|Drug|oxaliplatin|standard XELOX or FOLFOX regimen
16240972|NCT01077726|Drug|capecitabine [Xeloda]|1000mg/m2 po bid on days 1-14 of each 3 week cycle
16240973|NCT01077713|Drug|bevacizumab [Avastin]|7.5mg/kg iv on day 1 of each 3 week cycle
16240974|NCT01077713|Drug|cisplatin|60mg/m2 on day 1 of each 3 week cycle
16240975|NCT01077713|Drug|gemcitabine|1200mg/m2 on days 1-8 of each 3 week cycle
16240976|NCT01077713|Drug|gemcitabine|1000mg/m2 on days 1-8 of each 3 week cycle
16240977|NCT01077700|Drug|ABT-288 Low Dose|
16240978|NCT01077700|Drug|Placebo|inactive substance
16240979|NCT01077700|Drug|ABT-288 High Dose|
16240980|NCT01077661|Drug|Nebivolol|patients administrated Nebivolol according to the prescribing information
16240981|NCT01077648|Drug|Trastuzumab or Lapatinib|Anti-erbB2 therapy for breast cancer treatment will be analyzed as a class level variable; individual drugs including trastuzumab and lapatinib will also be explored as exposures if sufficient numbers of patients exist.
16240982|NCT01077635|Drug|Exposure to licensed dose of FPV (+/- 20% of 18mg/kg BID + RTV)|HIV-1 infected children currently or having ever been exposed to FPV (+/- 20% of 18mg/kg BID + RTV)
16240983|NCT01077622|Drug|ofatumumab 100 mg, 1000 mg / vial|ofatumumab , 300mg followed by 7 weekly infusions 2000 mg, followed by 4 monthly infusions 2000mg
16240984|NCT01077609|Drug|Intermittent, sub-chronic and chronic Flixonase use|Intermittent exposure episode is a series of fewer than four sequential prescriptions for Flixonase with gaps of no more than 60 days between any two. Sub-chronic use episode is a series of at least four and not more than eight sequential prescriptions for Flixonase with gaps of no more than 60 days between any two. Chronic use episode is a series of at least nine sequential prescriptions for Flixonase and gaps of no more than 60 days between any two. A span of at least 180 days must occur between the first and last prescription.
16240985|NCT01077609|Drug|Intermittent, sub-chronic and chronic use of intranasal steroids other than Flixonase|Intermittent exposure episode is a series of fewer than four sequential prescriptions for an intranasal steroid other than Flixonase with gaps of no more than 60 days between any two. Sub-chronic use episode is a series of at least four and not more than eight sequential prescriptions for an intranasal steroid other than Flixonase with gaps of no more than 60 days between any two. Chronic use episode is a series of at least nine sequential prescriptions for an intranasal steroid other than Flixonase and gaps of no more than 60 days between any two. A span of at least 180 days must occur between the first and last prescription.
16241062|NCT01076907|Other|Warm water|Warm water loading of sigmoid colon when spasms occur and waiting for them to subside.
16240988|NCT01077596|Drug|Regular TCA (Tricyclic antidepressants) use|Regular use of TCA is defined as use at least 4 times per week for at least 3 continuous months at least 12 months before index date.
16240989|NCT01077596|Drug|Regular use of any other antidepressant|"Regular use of any other antidepressants is defined as use at least 4 times per week for at least 3 continuous months at least 12 months before index date. An other antidepressant would be any antidepressant other than bupropion, a SSRI or a TCA."
16240990|NCT01077570|Drug|repaglinide|Repaglinide prescribed at the discretion of the investigator, according to local labelling, and evaluated at week 0, 8 and 16 of the study
16240991|NCT01077557|Other|No Antiretroviral (ARV) Drug Exposure|No pharmacy dispensing of an ARV drug
16240992|NCT01077557|Drug|Any Antiretroviral (ARV) Drug Exposure|Pharmacy dispensing claim for any ARV drug
16240993|NCT01077544|Drug|Nilotinib|"Nilotinib capsules were delivered in bottles with dose strengths of 50mg, 150mg and 200mg.
~Patients were administered nilotinib 230 mg/m2 (per BSA) bid, orally, rounded to the nearest 50 mg (max single dose 400 mg) for 28 days (1 cycle) for up to 12 cycles prior to protocol amendment 3 and up to 24 cycles post amendment 3. Capsules were to be swallowed whole with water. Apple sauce (puréed apple) may have been used as a vehicle for dosing where capsules were not able to be swallowed whole with water."
16240994|NCT01077531|Drug|Otelixizumab|Otelixizumab injection for intravenous infusion. Otelixizumab (GSK2136525) is a humanised, aglycosyl, non-mitogenic, anti CD3 monoclonal antibody (MAb).
16240995|NCT01077531|Drug|Matching placebo|Matching placebo for intravenous infusion
16240996|NCT01077518|Drug|Ofatumumab|Ofatumumab was a liquid concentrate solution for infusion presented in glass vials containing 50 mL of solution at a concentration of 20 mg/mL to provide 1000 mg per vial. The ofatumumab infusions were prepared in 1000 mL sterile, pyrogen-free 0.9% NaCl to yield a 1 mg/mL ofatumumab concentration infusion.
16240997|NCT01077518|Drug|Bendamustine infusion|Bendamustine 100 mg/vial, injection
16240998|NCT01077518|Drug|Ofatumumab and Bendamustine infusions (Arm A)|Up to 8 cycles of Bendamustine (90 mg/m2 Days 1 and 2, every 21 days) given in combination with 12 doses of ofatumumab (1000 mg). Ofatumumab will be given on day 1 of each cycle of bendamustine as long as patients in Arm A receive bendamustine. Once patients in Arm A complete bendamustine therapy, the remaining doses of ofatumumab will be given monthly until all 12 doses are completed.
16240999|NCT01077518|Drug|Bendamustine infusion (Arm B)|Bendamustine (120 mg/m2 Days 1 and 2, every 21 days, up to 8 cycles).
16241000|NCT01077505|Biological|albiglutide|albiglutide 50mg weekly subcutaneous injection
16241001|NCT01077505|Drug|Oral contraceptive (Brevicon)|Oral contraceptive (Brevicon)
16241002|NCT01077492|Other|Virtual Bronchoscopy Navigation|Use of dedicated virtual bronchoscopy navigation software using 4D CT-PET scan spacial data.
16241003|NCT01077479|Drug|Metformin|Metformin 1500mg nocte for 6 months
16241004|NCT01077466|Drug|Natalizumab|300 mg Natalizumab IV for every 4 week for 56 weeks (15 doses for every patient)
16241005|NCT01077453|Drug|letrozole|Given orally
16241006|NCT01077453|Other|quality-of-life assessment|Ancillary studies
16241007|NCT01077453|Other|laboratory biomarker analysis|Correlative studies
16241008|NCT01077440|Genetic|DNA analysis|DNA analysis will be performed on samples collected.
16241009|NCT01077440|Genetic|polymerase chain reaction|A polymerase chain reaction (PCR) assessment will be done on the samples collected.
16241010|NCT01077440|Other|flow cytometry|Flow cytometry will be done on the samples collected.
16241011|NCT01077440|Other|laboratory biomarker analysis|Laboratory biomarker analysis will be performed on the samples collected.
16241012|NCT01077427|Device|Gemcitabine + Cisplatin + regional hyperthermia|"Gemcitabine: 1000 mg/m² as iv-infusion on days 1 and 15 of each course (Total dose: 12 g/m²)
~Cisplatin: 25 mg/m² as iv-infusion on days 2, 3* and 16, 17* of each course (Total dose: 600 mg/m²)
~Regional hyperthermia: 60 minutes on days 2, 3*, and 16, 17* of each course
~* as an exception for medical or logistic reasons RHT and cisplatin can be applied day 4 instead of 3 and day 18 instead of 17"
16241013|NCT01077427|Drug|Gemcitabine + Capecitabine|"Gemcitabine: 1000 mg/m² as iv-infusion on days 1, 8 and 15 of each course (Total dose: 18 g/m²)
~Capecitabine: daily dose of 1660 mg/m²; administered orally for 21 days followed by 7 days' rest (one cycle) for six cycles"
16241014|NCT01077401|Drug|Ranibizumab|Intravitreal injections of ranibizumab 0.5mg dose for six monthly treatments then additional treatments with ranibizumab 0.5mg dose if the subject meets re-treatment criteria.
16241015|NCT01077401|Drug|ranibizumab|Intravitreal injections of ranibizumab 2.0 mg dose for six monthly treatments then additional treatments with ranibizumab 2.0 mg dose if the subject meets re-treatment criteria.
16241016|NCT01077388|Behavioral|Dietician electronic support|Dietitian-delivered behavioral intervention, that uses a patient shared EMR and e-communications, will be integrated into routine healthcare and will result in improved control of modifiable CVD risk.
16241017|NCT01077375|Drug|Placebo|"Placebo tablets, oral administration, twice daily for 10 weeks during randomized, double-blind treatment period. Duloxetine capsules, oral administration, 30 mg/day for 1 week after randomization to effect a duloxetine down-taper.
~Placebo tablets, twice daily for 1 week during double-blind down-taper treatment period."
16241018|NCT01077375|Drug|Milnacipran|"Milnacipran tablets, 100 to 200 mg/day, oral administration, twice daily in divided doses for 10 weeks during randomized, double-blind treatment period. Placebo capsules, 1 capsule/day administered for 1 week after randomization to maintain double-blind duloxetine down-taper.
~Milnacipran tablets, 100 to 0 mg/day, oral administration, twice daily in divided doses for 1 week during double-blind down-taper treatment period."
16241019|NCT01077362|Drug|placebo|SC injections
16241020|NCT01077362|Drug|ustekinumab 45 mg|SC injections
16241021|NCT01077362|Drug|ustekinumab 90 mg|SC injections
16241022|NCT01077349|Procedure|high volume hemofiltration|(80 ml/kg/h or a maximum of 8L/h) for 48 hours following heart surgery. Hemofiltration will be stopped after 48h if diuresis >1500 ml without diuretics and if IV infusion of catecholamines is less than 0.1 microg/kg/min of epinephrine, 0.2 microg/kg/min of norepinephrine or the sum of epinephrine + nor epinephrine/2 is less than 0.1 microg/kg/min. In other cases, hemodiafiltration (CVVHDF) will be initiated until the above objectives are reached, with equal flow rate of dialysate and reinfusion fluid, the sum of which being <35 ml/kg/h (or a maximum of 3500 ml/h).
16241063|NCT01076907|Other|Control|Air will be used instead of warm water for unsedated colonoscopy.
16241023|NCT01077349|Procedure|standard care|"extra-renal replacement therapy (CVVHDF mode, total effluent <35 ml/kg/h or a maximum of 3500 ml/h) will be initiated only if the following criteria are met:
~Serum creatinine > 350 micromol/L or increase x3.0 from pre-operative value OR
~Diuresis < 0.3 ml/kg/h for 24 hours despite adequate fluid resuscitation OR
~Or serum urea > 36 mmol/l OR
~Or life threatening hyperkalemia"
16241024|NCT01077323|Drug|exenatide|subcutaneous injection, dosing according to normal clinical practice
16241025|NCT01077323|Drug|Other antidiabetic therapies|Includes metformin, thiazolidinediones, insulins, sulfonylureas, non-sulfonylurea secretagogues, sitagliptin, and alpha-glucosidase inhibitors; In all cases, dosing according to normal clinical practice
16241026|NCT01077323|Other|No diabetes therapy|Subjects not diagnosed with diabetes
16241027|NCT01077310|Drug|Vivitrol- Intramuscular naltrexone (depot-formulation)|Subjects in this arm will receive monthly intramuscular gluteal injections of depot naltrexone 380mg (VIVITROL) for 6 months. The 1st injection will be administered prior to release from prison or jail.
16241028|NCT01077310|Drug|Placebo|Subjects in this arm will receive monthly intramuscular gluteal injections of placebo for 6 months. The 1st injection will be administered prior to release from prison or jail. Placebo will be provided by Alkermes pharmaceuticals, the manufacturer of VIVITROL. Placebo will be identical in shape and form to active drug.
16241029|NCT01077297|Drug|Tezosentan|single infusion of tezosentan 5mg/h over 30 min corresponding to 2.5 mg
16241030|NCT01077284|Drug|Febuxostat|Febuxostat capsules
16241031|NCT01077284|Drug|Allopurinol|Allopurinol capsules
16241032|NCT01077284|Drug|Placebo|Placebo-matching capsules
16241033|NCT01077245|Drug|MIYA-BM Fine Granules (CBM588)|MIYA-BM Fine Granules (CBM588)
16241034|NCT01077245|Drug|Placebo Fine Granules (without CBM588)|Placebo Fine Granules (without CBM588)
16241035|NCT01077206|Drug|Simvastatin|80mg daily versus 40mg daily, for 21 days.
16241036|NCT01077193|Procedure|Gastric Plication|"A laparoscope will be inserted to visualize the surgical area and confirm absence of injury to any surrounding organ or structure. A flexible endoscope will be passed transorally into the gastric lumen to provide insufflation.
~The greater curvature of the stomach is separated from the greater omentum using a harmonic scalpel starting approximately 3cm from the pylorus and ending at or near the angle of His. As needed, adhesions to the posterior surface of the stomach may be transected.
~At least two rows of at least five continuous stitches will be placed laparoscopically about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure, ensuring one exists after the procedure."
16241037|NCT01077180|Device|Implantation of the Rheos System|Open label
16241038|NCT01077180|Other|Standard of care medical management|Patients will continue with medical therapy for standard of care of their hypertension.
16241039|NCT01077167|Drug|Omecamtiv mecarbil|Oral dosing twice each day or three times each day, depending on the cohort assignment, of Omecamtiv mecarbil for 8 days. Omecamtiv mecarbil comes in 2 formulations: modified release and immediate release, and the formulation given will depend on the cohort assignment.
16241040|NCT01077154|Drug|Placebo|Administered subcutaneously for up to 5 years
16241041|NCT01077154|Drug|Denosumab|Administered subcutaneously for up to 5 years
16241042|NCT01077115|Procedure|Laparoscopic cholecystectomy|
16241043|NCT01077115|Procedure|Open Surgery|
16241044|NCT01077102|Other|Eccentric exercise training|The eccentric exercise training will be performed using a specially built cycle ergo meter where the pedals are driven in backward direction by an electric motor, which has to overcome the adjustable resistance of the electromagnetic brake. During eccentric cycle ergometry patients have to resist the turning pedals.
16241045|NCT01077076|Drug|Zegerid|Zegerid taken once daily for 11 days.
16241046|NCT01077076|Drug|Prilosec OTC™ Tablets|Prilosec OTC™ Tablets taken once daily for 11 days.
16241047|NCT01077076|Other|Placebo|Placebo taken once daily for 11 days.
16241048|NCT01077063|Procedure|paracentesis|surgical drainage of malignant ascites
16241049|NCT01077063|Device|Pleurx catheter|take home catheter drainage system that the subject uses himself/herself as needed.
16241050|NCT01077050|Device|SciBase III Electrical Impedance Spectrometer|SciBase III Electrical Impedance Spectrometer is based on Electrical Impedance Spectroscopy (EIS). EIS is a measure of the overall resistance within a skin tissue, at alternating currents of various frequencies. Enrolled subject will undergo skin measurements with SciBase III Electrical Impedance Spectrometer. The relevant skin lesion(s) will be excised and diagnosed as per routine treatment.
16241051|NCT01077037|Other|Decision Aid|Chest pain choice decision aid
16241052|NCT01077024|Other|Smoking-cessation treatment|Smoking cessation treatment includes four components: 1. brief weekly individual smoking-cessation counseling study weeks 1-10; 2. extended-release (XL) bupropion (300 mg/day)study weeks 1-10; 3. nicotine inhaler (6-16 cartridges per day ad libitum)during the post-quit treatment phase; 4. prize-based contingency management during the post-quit treatment phase.
16241053|NCT01077011|Other|Lubricant eye drop FID 115958D|1 drop in each eye, one time
16241054|NCT01077011|Other|GenTeal Gel|1 drop in each eye, one time
16241055|NCT01076998|Other|Lubricant eye drop FID 115958D|1 drop in each eye, one time
16241056|NCT01076998|Other|Refresh PM Ointment|1 drop in each eye, one time
16241057|NCT01076985|Drug|Lopinavir/ritonavir (Kaletra)|Lopinavir/ritonavir (LPV/r) evaluated separately in patients who were naive to previous antiretroviral treatment and those who were not.
16241058|NCT01076972|Drug|Lopinavir/ritonavir (Kaletra)|Lopinavir/ritonavir evaluated separately in patients who were naive to previous antiretroviral treatment and those who were not.
16241059|NCT01076933|Procedure|repetitive Transcranial Stimulation Magnetic (rTMS)|The motor threshold was determined in each subject once, before treatment. This was defined as the lowest stimulation intensity capable of inducing a visible movement at least five times out of 10 stimulations. The position of the right dorsolateral prefrontal cortex was defined as 5 cm anterior (in a parasagittal line) to the motor cortex. The stimulus intensity was 80% of the patient's motor threshold intensity. Treatments were given for 20 minutes per day over 10 working days.
16241060|NCT01076933|Procedure|sham rTMS|sham rTMS
16241061|NCT01076920|Genetic|Mesenchymal stem cells|60x106 MSCs Trans-endocardial intramyocardial injections (n=14-16)
16241388|NCT01074346|Drug|Interferon-β-1a|Interferon-β-1a according to the standard practice
16241064|NCT01076894|Procedure|epidural anesthesia|In the epidural group prior to the induction of general anesthesia, a thoracic epidural catheter will be was placed at the level of the TH6-TH8. 8 ml ropivacaine 1% were administered through the epidural catheter. EDA is aimed at a sensory block level from TH2 to TH10.
16241065|NCT01076894|Procedure|intercostal anesthesia|In the intercostal group, before chest closure, each 4 ml ropivacaine 0.75 % will be injected by the surgeon under direct vision into the proximal intercostal space at the level of the thoracotomy and two spaces above and below as well as 5 ml ropivacaine 0,75 % at the thoracic drainage tube exits
16241066|NCT01076881|Behavioral|exercise training|
16241067|NCT01076868|Drug|Primaquine|Primaquine x 14 days
16241068|NCT01076842|Drug|Insulin-Levemir|Levemir once daily, force titrated to reach a fasting plasma glucose of 100 mg/dl
16241069|NCT01076842|Drug|Exenatide-Bayetta|Exenatide twice daily, started at a dose of 5 mcg b.i.d. and increased to 10 mcg b.i.d. after 2 weeks if the fasting plasma glucose of 100 mg/dl is not reached. Exenatide will be administered immediately before breakfast and dinner meals. No further increase in the dose of exenatide will take place. For those who are unable to tolerate exenatide at a 10 mcg b.i.d. dose, it will be reduced to 5 mcg b.i.d. and continued until week 12.
16241070|NCT01076842|Drug|Insulin-Levemir and Exenatide-Bayetta|Patients from either Group A or Group B who have not reached the goal A1C of 6.5% will be assigned to this Group. They will receive the drug assigned to the other group in addition to the one they were originally assigned.
16241071|NCT01076842|Device|SenseWear Pro3® armband|For one-week prior to beginning the assigned medication and for one week , week 11 and week 23, the patients will wear the SenseWear Pro3® armband for collection of ancillary physiologic data
16241072|NCT01076842|Device|DexCom CGM|For one-week prior to beginning the assigned medication and for one week , week 11 and week 23, the patients will wear the DexCom CGM for collection of continuous blood glucose concentrations.
16241073|NCT01076829|Other|Spice polyphenols|spice
16241074|NCT01076816|Drug|dexmedetomidine|"dexmedetomidine will be given max 48h. In case analgosedation is still needed after stop of the dexmedetomidine infusion, the treatment is switched to conventional analgosedation regimens.
~Additional drugs are given to every inadequately sedated patient (assessed by regular Comfort scoring). In case of oversedation or adverse drug events (hypotension, bradycardia), a downtitration (or stop) of the dexmedetomidine infusion is needed."
16241075|NCT01076816|Procedure|Vital signs|systolic and diastolic blood pressure, heart rate, respiratory rate,oxygen saturation, temperature are assessed baseline and at least per hour reassessed after starting the dexmedetomidine.
16241076|NCT01076816|Procedure|blood sampling|Blood sampling for pharmacokinetic modelling is limited to a maximum of 1,8 ml/kg (in line with the EMEA guidelines on maximum blood sampling in children). Pharmacokinetic parameters and influence of covariates on these parameters will be assessed by a population pharmacokinetic approach.
16241077|NCT01076803|Drug|Lanreotide (acetate)|Deep subcutaneous injection into the upper external quadrant of the right or the left buttock.
16241078|NCT01076790|Drug|Dexmedetomidine|Dexmedetomidine infusion 1 mcg/kg in 10 minutes; thereafter 0.7 mcg/kg/h until 30 minutes has elapsed from skin incision.
16241079|NCT01076790|Drug|Saline|Saline infusion 1 mcg/kg in 10 minutes; thereafter 0.7 mcg/kg/h until 30 minutes has elapsed from skin incision.
16241080|NCT01076777|Behavioral|Physical exercise|Manualised Exercise performed in groups (5-8 participants per group). 3 sessions (á 60 minutes) per week for 12 consecutive weeks
16241081|NCT01076777|Behavioral|Cognitive-behavioral therapy|Cognitive-behavioral therapy conducted in groups (5-8 participants per group). 1 session (á 2-2.25 hours depending on group size) per week for 12 consecutive weeks
16241082|NCT01076764|Drug|Otamixaban|"Pharmaceutical form: Intravenous (IV) solution
~Route of administration: IV bolus followed by continuous IV infusion"
16241083|NCT01076764|Drug|Placebo (for Otamixaban)|"Pharmaceutical form: Intravenous (IV) solution
~Route of administration: IV bolus followed by continuous IV infusion"
16241084|NCT01076764|Drug|UFH|"Pharmaceutical form: Intravenous (IV) solution
~Route of administration: IV bolus followed by continuous IV infusion"
16241085|NCT01076764|Drug|Placebo (for UFH)|"Pharmaceutical form: Intravenous (IV) solution
~Route of administration: IV bolus followed by continuous IV infusion"
16241086|NCT01076764|Drug|Eptifibatide|"Pharmaceutical form: Intravenous (IV) solution
~Route of administration: IV bolus followed by continuous IV infusion"
16241087|NCT01076764|Drug|Placebo (for Eptifibatide)|"Pharmaceutical form: Intravenous (IV) solution
~Route of administration: IV bolus followed by continuous IV infusion"
16241088|NCT01076725|Device|Standard technique group|In the standard technique group (n = 63), the PLMA was inserted by index finger insertion technique.
16241089|NCT01076725|Device|Rotation technique group|The entire cuff of the PLMA was placed in the mouth without finger insertion in a midline approach and was rotated 90 degrees counterclockwise around the tongue. The PLMA was then advanced and rotated back until resistance was felt.
16241090|NCT01076712|Other|Physiotherapy Interventions|Physiotherapy interventions including strengthening exercise, balance training, gait training with visual cus and gait training with treadmill
16241091|NCT01076712|Other|Education Classes|Education Classes
16241092|NCT01076699|Drug|0.075 mg RVX-100|This group is taking the lowest dose of RVX-100
16241093|NCT01076699|Drug|0.125 mg RVX-100|This group is taking an average dose of RVX-100
16241094|NCT01076699|Drug|0.250 mg RVX-100|This group is taking the highest dose of RVX-100
16241095|NCT01076699|Drug|placebo|This group is taking a placebo
16241096|NCT01076686|Drug|Questionnaire and Physical Exam|A 10-question survey and a six-item physical exam were completed.
16241097|NCT01076673|Biological|Peripheral blood stem cells and hyaluronic acid injections|Peripheral blood stem cells and hyaluronic acid injections
16241098|NCT01076673|Drug|Hyaluronic Acid|Hyaluronic acid injections
16241099|NCT01076647|Drug|insulin degludec|Will be injected subcutaneously (under the skin) once daily three times weekly.
16241100|NCT01076647|Drug|insulin glargine|Will be injected subcutaneously (under the skin) once daily administered at the same time each day.
16241101|NCT01076634|Drug|insulin degludec|0.4 U/kg body weight. Injected subcutaneously (under the skin) once daily for 8 days.
16241102|NCT01076634|Drug|insulin degludec|0.4 U/kg body weight. Injected subcutaneously (under the skin) once daily for 8 days.
16241680|NCT01072188|Device|Nupro - Fluoride Free|Brush twice daily
16241103|NCT01076621|Drug|0.5 mg estradiol / 0.1 mg norethisterone acetate (NETA)|Data collection of the use of 0.5 mg estradiol and 0.1 mg norethisterone acetate (NETA) in women in connection to a daily clinical practice.
16241104|NCT01076595|Drug|Interferon beta-1b (Betaseron, BAY86-5046)|Betaferon 250 microgram
16241105|NCT01076582|Drug|EE20/DRSP (YAZ, BAY86-5300)|4 cycles of treatment / per cycle: 1 tablet (EE 0.02 mg / DRSP 3 mg) daily for 24 days followed by 1 placebo tablet daily for 4 days
16241106|NCT01076582|Drug|Ethinylestradiol (EE) and desogestrel (DSG) (Mercilon)|4 cycles of treatment / per cycle: 1 tablet (EE 0.02 mg / DSG 0.15 mg) daily for 21 days followed by 1 placebo tablet daily for 7 days
16241107|NCT01076569|Other|laboratory biomarker analysis|Correlative studies
16241108|NCT01076556|Drug|Alvocidib Hydrochloride|Given IV
16241109|NCT01076556|Drug|Cyclophosphamide|Given IV
16241110|NCT01076556|Other|Diagnostic Laboratory Biomarker Analysis|Correlative studies
16241111|NCT01076556|Other|Pharmacological Study|Correlative studies
16241112|NCT01076556|Biological|Rituximab|Given IV
16241113|NCT01076543|Other|Laboratory Biomarker Analysis|Correlative studies
16241114|NCT01076543|Drug|Lenalidomide|Given PO
16241115|NCT01076543|Drug|Temsirolimus|Given IV
16241116|NCT01076530|Drug|vorinostat|
16241117|NCT01076530|Drug|temozolomide|
16241118|NCT01076530|Other|diagnostic laboratory biomarker analysis|
16241119|NCT01076530|Other|pharmacological study|
16241120|NCT01076517|Device|Therasphere|Beta-emitting 90yttrium encapsulated in glass microspheres for intraarterial administration to the liver.
16241121|NCT01076504|Drug|Amrubicin|30 mg/m2 IV on Days 1-3 of each 3-week treatment cycle
16241122|NCT01076504|Drug|Carboplatin|AUC=5 IV, Day 1 of each 3-week treatment cycle
16241123|NCT01076504|Drug|Pegfilgrastim|6 mg SQ on Day 4 of each 3 week treatment cycle
16241124|NCT01076491|Drug|mannitol|inhaled mannitol - single doses of either 70 mg or 90 mg
16241125|NCT01076478|Drug|Cilostazol|100 mg, 200mg tablet Cilostazol
16241126|NCT01076465|Other|Disease management program|1. Educational intervention on management of heart failure and comorbidity to improve patient's knowledge of his/her disease and self-care 2) Monitoring of clinical status 3) Monitoring and improvement of therapeutic adherence.
16241127|NCT01076465|Behavioral|Usual care|Usual care
16241128|NCT01076452|Device|Bilateral Deep Brain Stimulation|The DBS site (STN or GPi) was assigned on a random basis at the time the patient enters the surgical phase of the trial.
16241129|NCT01076439|Drug|Fluticasone Furoate Nasal Spray|Fluticasone Furoate Nasal Spray: 110mcg QD
16241130|NCT01076439|Drug|Olopatadine Nasal Spray|Olopatadine Nasal Spray: 2660mcg BID
16241131|NCT01076439|Drug|Saline Nasal Spray|Placebo
16241132|NCT01076426|Drug|Pro-biotics|Pro-biotics and placebo one pack per day is given to the two group. And then evaluate the peritonitis rate and nutrition status.
16241133|NCT01076426|Dietary Supplement|Oligosaccharide|oligosaccharide one pack per day
16241134|NCT01076413|Behavioral|skill based exercise|2 times per week for 12 weeks Pre gait and gait activities
16241135|NCT01076413|Behavioral|aerobic conditioning|2 times per week for 12 weeks. aerobic conditioning exercise consisting of treadmill walking
16241136|NCT01076400|Drug|MK-1775|MK-1775 capsules are administered in sequentially rising dose levels twice daily for a total of nine doses on Days 1-5 of a 21-day cycle.
16241137|NCT01076400|Drug|Topotecan|Topotecan is administered at a dosage of 0.75 mg/m^2 by intravenous (IV) infusion over 30 minutes on Days 1-3.
16241138|NCT01076400|Drug|Cisplatin|Cisplatin is administered at a dosage of 50 mg/m^2 by IV infusion over 30 minutes on Day 1.
16241139|NCT01076400|Drug|Placebo to MK-1775|Placebo to MK-1775 capsules are administered in sequentially rising dose levels twice daily for a total of nine doses on Days 1-5 of a 21-day cycle.
16241140|NCT01076387|Procedure|open radical cystectomy|Open radical cystectomy, pelvic lymph node dissection and open urinary diversion.
16241141|NCT01076387|Procedure|robotic-assisted radical cystectomy|Robotic radical cystectomy, pelvic lymph node dissection and open urinary diversion. Robotic radical cystectomy is routinely performed by robotically trained and experienced minimally invasive surgeons.
16241142|NCT01076335|Drug|Neoadjuvant Hormonal Therapy|Monthly or quarterly LHRH Agonist Depot injection (leuprolide or goserelin acetate) for one year.
16241143|NCT01076335|Drug|Docetaxel|35 mg/m2 by vein (IV) on Day 1, 8, 15 and 22 every 6 weeks.
16241144|NCT01076322|Drug|Meptin® Swinghaler|"Meptin® Swinghaler®
~Ingredient: Procaterol HCL
~Dosage form: 10g/puff
~Dose(s): 10g
~Dosing schedule: 20g (total 20g)"
16241145|NCT01076322|Drug|Ventolin® MDI|"Ventolin® MDI
~Ingredient: Salbutamol sulfate
~Dosage form: 100g/puff
~Dose(s): 100g
~Dosing schedule: 200g (total 200g)"
16241146|NCT01076283|Drug|Baclofen|Baclofen 10mg t.i.d.
16241147|NCT01076283|Drug|Cyproheptadine|'active' placebo
16241148|NCT01076270|Drug|plerixafor|Given SC
16241149|NCT01076270|Biological|filgrastim|Given SC
16241150|NCT01076270|Procedure|peripheral blood stem cell transplantation|Infusion of peripheral blood stem cells
16241151|NCT01076270|Procedure|allogeneic hematopoietic stem cell transplantation|Infusion of hematopoietic stem cells
16241152|NCT01076257|Behavioral|Modified Constraint-induced Movement Therapy|"Home based CIT
~Restriction of the less affected limb
~Intensive practice using affected limb
~Positive experience
~Functional task (task)"
16241153|NCT01076244|Procedure|Minimally Invasive Lumbar Decompression|This minimally invasive procedure is performed under fluoroscopic image guidance through a dorsal approach to the spine. The patient is given local anesthesia and a sedative but needs to be responsive to the surgeon's questions for neurological monitoring. Under image guidance, the mild tools are inserted and positioned on the posterior spinal lamina, to the left or right of the spinous process. The tools are used to cut and remove tissue and bone from the posterior side of the lumbar spine to create a space inside the spine that can help decompress some of the spinal nerves.
16241154|NCT01076231|Radiation|proton beam radiation therapy|
16241155|NCT01076231|Drug|cisplatin|Given IV
16241156|NCT01076231|Drug|etoposide|Given IV
16241157|NCT01076231|Procedure|therapeutic conventional surgery|
16241328|NCT01074866|Device|Neurally Adjusted Ventilatory Assist|Non invasive ventilation under Neurally adjusted Ventilatory Assist
16241158|NCT01076218|Device|FreeStyle Navigator Continuous Glucose Monitoring System Version 1.5|This is not an interventional study. Subjects must maintain their own diabetes treatment regimen throughout the study duration.
16241159|NCT01076166|Drug|clarithromycin (Klacid) granules for oral suspension|clarithromycin (Klacid) Granules for Oral Suspension
16241160|NCT01076153|Drug|Clarithromycin (Klacid® MR)|Klacid MR 500mg (clarithromycin)
16241161|NCT01076140|Drug|Nebivolol|Nebivolol 5 or 10 mg tablets daily for 4 weeks. Lisinopril 20 or 40 mg daily for 4 weeks
16241162|NCT01076140|Drug|Lisinopril|Nebivolol 5 or 10 mg tablets daily for 4 weeks. Lisinopril 20 or 40 mg daily for 4 weeks
16241163|NCT01076127|Behavioral|Ketllebell training|Kettlebell training 3 x 20 min a week for 8 weeks
16241164|NCT01076127|Behavioral|Control|Receives a health examination before and after the intervention period, and are advised to stay active.
16241165|NCT01076088|Drug|Sitagliptin 50 mg|Sitagliptin 50 mg tablet twice a day, prior to the morning and evening meal, for 24 weeks.
16241166|NCT01076088|Drug|Metformin 500 mg|Metformin 500 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.
16241167|NCT01076088|Drug|Sitagliptin 100 mg|Sitagliptin 100 mg once daily for 24 weeks.
16241168|NCT01076088|Drug|Placebo|Matching placebo tablets to sitagliptin or metformin for 24 weeks.
16241169|NCT01076088|Drug|Metformin 850 mg|Metformin 850 mg tablet twice daily, prior to the morning and evening meal, for 24 weeks.
16241170|NCT01076075|Drug|Sitagliptin phosphate|Phase A (Weeks 0-24): Sitagliptin 100 mg once a day for 24 weeks; Phase B (Weeks 24-54): Sitagliptin 100 mg once a day for 30 weeks
16241171|NCT01076075|Drug|Comparator: placebo to pioglitazone|Phase B (Weeks 24-54): placebo to pioglitazone 30 mg once a day for 30 weeks
16241172|NCT01076075|Drug|Comparator: placebo to Sitagliptin|Phase A (Weeks 0-24): placebo to Sitagliptin 100 mg once a day for 24 weeks; Phase B (Weeks 24-54): placebo to Sitagliptin once a day for 30 weeks
16241173|NCT01076075|Drug|Comparator: pioglitazone|Phase B (Weeks 24-54): pioglitazone 30 mg once a day for 30 weeks
16241174|NCT01076075|Drug|Glimepiride or gliclazide|Phase A (Weeks 0-24): stable dose, as prescribed by investigator, of glimepiride or gliclazide; Phase B (Weeks 24-54): stable dose, as prescribed by investigator, of glimepiride or gliclazide
16241175|NCT01076075|Drug|Metformin|"Phase A (Weeks 0-24): stable dose, as prescribed
~by investigator, of metformin; Phase B (Weeks 24-
~54): stable dose, as prescribed by investigator, of
~metformin"
16241176|NCT01076075|Drug|Pioglitazone rescue therapy|Phase A (Weeks 0-24): participants not meeting specific glycemic goals will receive pioglitazone (open label) at a dose determined by the investigator. These participants will not initiate Phase B (Weeks 24-54) double blind pioglitazone.
16241177|NCT01076062|Procedure|Induction of Labor|If cervical foley bulb placement is possible, the foley bulb will remain in place until either spontaneously removed or after 12 hrs, whichever is earlier. If placement is not possible, cervical ripening with misoprostol 25 micrograms (mcg) per vagina every 4 hrs (max of 4 total doses) will be initiated. Cervical examination will occur every 4 hr. Repeat doses of misoprostol will be given only if foley bulb placement is not possible and/or if palpably firm uterine contractions are less than 6 in 10 min in consecutive 10 min intervals. Once placement of a cervical foley bulb can be performed, oxytocin administration will begin at 2 mIU/min and increasing by 2 mIU/min every 20 min to ensure adequate contractions (maximum oxytocin infusion rate 36 mIU/min). Adequate contractions will be defined as 7 contractions in 15 min in consecutive 15 min intervals that palpate moderate to firm. Oxytocin infusion will begin not earlier than 4 hrs after the last misoprostol dose (if given).
16241178|NCT01076049|Device|Standard of Care (SoC)|The preferred irrigation solution and method was chosen by the site's emergency department physician(s) and could vary between subjects. The type of SoC was recorded in the source document and the same solution and irrigation method were used during the initial treatment and 48-hour follow-up visits.
16241179|NCT01076049|Device|Irrisept Delivery System|"Irrisept is a manual, self-contained irrigation device capable of producing 7-8 psi of pressure for effective wound cleansing and irrigation. Irrisept contents include the Chlorhexidine Gluconate (CHG) solution, a 450 mL bottle, and Irriprobe applicator or an abscess irrigation tip. The bottle design allows users to control the pressure of the solution through manual bottle compression.
~Irrisept was recorded in the source document and used during the initial treatment and 48-hour follow-up visits."
16241180|NCT01076036|Device|CorPath 200|CorPath™ 200 robotically-assisted percutaneous coronary intervention
16241181|NCT01076036|Device|CorPath 200|CorPath PCI - robotic-assisted percutaneous coronary intervention
16241182|NCT01076010|Drug|Tivozanib|Tivozanib capsules, administered orally, on a dosing schedule of 3 weeks of treatment (beginning on Day 1) followed by 1 week off treatment. One cycle was defined as 4 weeks of treatment.
16241183|NCT01076010|Drug|Sorafenib|Sorafenib tablets, 400 mg twice daily, administered orally for 4 weeks (1 cycle = 4 weeks). One cycle was defined as 4 weeks of treatment. Cycles were repeated every 4 weeks.
16241184|NCT01075997|Device|cell phone delivered tele-educational|This group will receive a cell phone and cell phone service for 1 year. This group will receive a daily video reminders and tips for the first 6 months of the study. For the second 6 months this group will be seen by their providers at least every 3 months, but the video reminders and and tips will no longer be sent. The group will be instructed on how to use the cell phone.
16241185|NCT01075997|Device|cell phone|This group will receive a cell phone and cell phone service for 1 year. For the second 6 months this group will be seen by their providers at least every 3 months. The group will be instructed on how to use the cell phone.The group will be asked to check blood sugar on a schedule determined by your provider. The groups will have blood sugars downloaded from from the glucometer by your provider at every visit and reviewed.
16241186|NCT01075984|Drug|Posaconazole|
16241187|NCT01075984|Drug|Dextrose 5% in water|
16241188|NCT01075971|Drug|Buprenorphine hydrochloride marketed sublingual tablet (Subutex)|8 mg or 16 mg daily, sublingual route on Days 1 and 2
16241189|NCT01075971|Drug|Buprenorphine hydrochloride fast dissolving tablet (FDT)|8 mg or 16 mg daily, sublingual route on Days 3, 4, and 5
16241190|NCT01075945|Drug|Dihydroartemisinin- piperaquine|three tablets per day
16241191|NCT01075945|Drug|artemether- lumefantrine|twenty tablet in eight doses
16241329|NCT01074853|Drug|propranolol|10mg twice daily escalated to 80mg once daily
16241330|NCT01074853|Drug|placebo|Matched placebo
16241192|NCT01075932|Dietary Supplement|DHA-rich fish oil|Either 1 g or 2 g DHA-rich fish oil taken daily for 12 weeks. Participants in the 1 g group will also consume 1 g olive oil placebo capsules per day to maintain double blind.
16241193|NCT01075932|Dietary Supplement|Placebo|2 g placebo (olive oil) taken daily for 12 weeks
16241194|NCT01075919|Dietary Supplement|n-3 PUFAs|1 g DHA-rich fish oil taken daily for 12 weeks
16241195|NCT01075919|Dietary Supplement|Placebo|1 g olive oil taken daily for 12 weeks
16241196|NCT01075919|Dietary Supplement|n-3 PUFAs|1 g EPA-rich fish oil taken daily for 12 weeks
16241197|NCT01075906|Drug|colchicine sprinkle capsules|0.3 mg
16241198|NCT01075906|Drug|colchicine sprinkle capsules|0.3 mg
16241199|NCT01075880|Drug|Rebif (Interferon beta-1a)|The treatment to be administered is interferon beta-1a on prescription, used as per SmPC, i.e. both doses 22 and 44 mcg s.c. tiw, and the titration pack 8.8 mcg and 22 mcg s.c. tiw when initiating the therapy.
16241200|NCT01075854|Drug|Gonal-F (Follitropin alfa)|Follitropin alfa FbM solution for injection in a prefilled pen is available in three strengths: 300 IU/0.5 ml (22 µg/0.5 ml), 450 IU/0.75 ml (33 µg/0.75 ml) and 900 IU/1.5 ml (66 µg/1.5 ml). The starting dose is usually recommended to be between 150 and 300 IU. The dose is then adjusted according to the ovarian response.
16241201|NCT01075841|Drug|Cetuximab|Subjects who are eligible for Erbitux treatment according to the indication in the national label of Erbitux (i.e. where Erbitux is used in combination with platinum-based therapy for the treatment of subjects with recurrent and/or metastatic SCCHN) according to the approved national label as in routine clinical practice under the supervision of an investigator experienced in the use of antineoplastic medicinal products.
16241202|NCT01075828|Drug|Cetuximab|Subjects will be treated according to the national label of cetuximab in combination with radiation therapy.
16241203|NCT01075815|Drug|Recombinant human luteinizing hormone (rhLH)|
16241204|NCT01075815|Drug|Recombinant follicle-stimulating hormone (rFSH)|
16241205|NCT01075802|Drug|Tamoxifen|Dose escalation
16241206|NCT01075789|Drug|Lignocaine|Lignocaine 10% solution administered intra nasally plus lignocaine 2% solution administered orally.
16241207|NCT01075789|Drug|Placebo|Viscous, coloured, sucrose flavoured gel solution to match xylocaine viscous in appearance, normal saline administered intranasally to the nasal turbinates and nasopharynx.
16241208|NCT01075776|Drug|C-type natriuretic peptide (CNP)|360 pmol/min for 15 minutes intra-arterially
16241209|NCT01075776|Drug|Saline|Sodium Chloride 0.9% intra-arterially 0.5ml/min
16241210|NCT01075776|Drug|Acetylcholine|2 stepped infusions for a total 9min per limb, totalling 1.05micromoles per limb
16241211|NCT01075763|Drug|Interferon beta-1a|Interferon (IFN) beta-1a [Rebif® 22 microgram (mcg), three times per week (tiw)] administered subcutaneously (sc)
16241212|NCT01075763|Drug|Placebo|The inactive substance (placebo) looks the same as Interferon beta-1a (Rebif®), and is given the same way
16241213|NCT01075724|Device|Patient Warming with Forced Air|Forced Air warming via BairHugger
16241214|NCT01075724|Device|Resistive Warming|Resistive Warming via HotDog device
16241215|NCT01075711|Drug|Prednisone|According to SPC
16241216|NCT01075698|Drug|Non-ARB (standard therapy)|Blood pressure lowering therapy except ARB
16241217|NCT01075698|Drug|ARB (Telmisartan)|Telmisartan 20-80 mg/day
16241218|NCT01075685|Behavioral|interactive online programme to reduce alcohol consumption|"The programme includes several steps:
~personalized feedback on alcohol consumption and related risks
~reviewing motivations and fears regarding drinking reduction
~analyse of drinking habits
~reduction goal setting
~follow-up tools (alcohol diary, craving scales, well-being scales)
~a final screen allowing participants to monitor their progress through graphs and automatically adapted comments."
16241219|NCT01075685|Behavioral|Minimum information|"This intervention includes:
~information about hazardous drinking
~an alcohol diary"
16241220|NCT01075672|Behavioral|Cognitive behavioral therapy (CBT)|The participant will then undergo a structured clinical interview with a supervised psychology intern/fellow, which will take approximately 1-3 hours over the course of 1-3 sessions. The initial assessment will be followed by up to 24 sessions of cognitive behavioral therapy tailored to their particular diagnosis (most diagnoses/problems require approximately 12 sessions, some require fewer, others require more). The length of treatment will depend on the primary diagnosis/ problem and the complexity and severity of the case. The clinician and patient will agree on a treatment plan after the initial evaluation, targeting a particular mental health or health related behavioral problem with Cognitive Behavioral Therapy. This treatment plan will include an agreed upon number of treatment sessions (up to 24).
16241221|NCT01075659|Drug|Nicotine|Two single doses of experimental Nicotine Replacement Therapy (NRT) 2 mg, with five hours between treatments. Seven hours duration of total follow-up period
16241222|NCT01075659|Drug|Nicotine|Two single doses of Nicotine Lozenge 2 mg, with five hours between treatments. Seven hours duration of total follow-up period.
16241223|NCT01075659|Drug|Nicotine|Two single doses of Nicotine Lozenge 4 mg, with five hours between treatments. Seven hours duration of total follow-up period.
16241224|NCT01075646|Drug|ropivacaine|"Laparotomy of colorectal surgery: 10 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 5ml/h.
~Laparoscopy of colorectal surgery: 5 ml bolus ropivacaine 0,75% + infusion with elastomeric pump with ropivacaine 0,38% at a 2 ml/h.
~Hepatic surgery: 10 ml de ropivacaine 0,45% + infusion with elastomeric pump with ropivacaine 0,23 at a 5ml/h."
16241225|NCT01075646|Drug|saline solution|"Laparotomy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h.
~Laparoscopy of colorectal surgery: 10 ml bolus saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 2 ml/h.
~Hepatic surgery: 10 ml de saline solution 0.9% + infusion with elastomeric pump with saline solution 0.9% at a 5ml/h"
16241226|NCT01075633|Procedure|Immunochemical fecal occult blood test And colonoscopy if test is positive|Annual (3 rounds), without diet restriction, 1 stool sample. Positive cut-off level: 50 ng/ml.
16241227|NCT01075633|Procedure|Colonoscopy with sedation|Colonoscopy with sedation
16241228|NCT01075620|Device|PFC-Sigma RP|Posterior stabilizing rotating platform total knee components
16241229|NCT01075620|Device|LPS RP|non-posterior stabilized rotating platform design
16241331|NCT01074840|Other|Peanut flour|Peanut-allergic subjects will be given peanut flour in increasing amounts.
16241230|NCT01075581|Drug|Epinephrin (Intranasal injection)|A total of 8 mL of epinephrine 1:100,000 will be injected in the lateral nasal wall, followed by placement of cotton pledgets (soaked in 1 mL epinephrine 1:1,000) in the nasal cavity when required.
16241231|NCT01075581|Drug|Epinephrin (Topical administration)|An intranasal injection of saline solution, followed by placement of cotton pledgets (soaked in 1 mL epinephrine 1:1,000) in the nasal cavity when required.
16241232|NCT01075568|Dietary Supplement|Nutrigal Okara - 100|
16241233|NCT01075555|Drug|pravastatin sodium|
16241234|NCT01075555|Drug|sorafenib tosylate|
16241235|NCT01075542|Device|AcrySof Toric intraocular lens, model SN60TT|The lens is made of foldable acrylic material and is implanted in the capsular bag
16241236|NCT01075542|Device|AcrySof Monofocal IOL, model SN60AT|The lens is made of foldable acrylic material and is implanted in the capsular bag
16241237|NCT01075529|Drug|fluoxetine|fluoxetine 20 mg/d
16241238|NCT01075503|Procedure|brachial plexus block|0.5% Ropivacaine 40ml
16241239|NCT01075490|Drug|clonidine|addition of 1 µg/kg of clonidine to bupivacaine 1 mg/kg as spinal anesthesia
16241240|NCT01075490|Drug|clonidine|equivalent volume of saline added to bupivacaine, 1 mg/kg as spinal anesthesia
16241241|NCT01075477|Drug|rituximab [Mabthera/Rituxan]|As prescribed by physician
16241242|NCT01075464|Drug|MEGF0444A|Intravenous escalating dose
16241243|NCT01075464|Drug|bevacizumab|Intravenous repeating dose
16241244|NCT01075464|Drug|paclitaxel|Intravenous repeating dose
16241245|NCT01075438|Biological|Prevenar® (7-valent pneumococcal conjugate vaccine)|"Pneumococcal vaccines (conjugate and polysaccharide)
~Intramuscular Injections: 2 doses of 7-valent pneumococcal conjugate vaccine 8 weeks apart and 1 dose of pneumococcal polysaccharide vaccine 8 weeks later"
16241246|NCT01075438|Biological|Pneumovax® (pneumococcal polysaccharide vaccine)|"Pneumococcal vaccines (conjugate and polysaccharide)
~Intramuscular Injections: 2 doses of 7-valent pneumococcal conjugate vaccine 8 weeks apart and 1 dose of pneumococcal polysaccharide vaccine 8 weeks later"
16241247|NCT01075425|Drug|bortezomib|Given IV
16241248|NCT01075425|Drug|belinostat|Given IV
16241249|NCT01075425|Other|laboratory biomarker analysis|Correlative studies
16241250|NCT01075425|Genetic|western blotting|Correlative studies
16241251|NCT01075425|Other|pharmacological study|Correlative studies
16241252|NCT01075425|Other|flow cytometry|Correlative studies
16241253|NCT01075412|Drug|[F18]Fluorothymidine|FLT PET scan 5 mCi (+/- 10%)
16241254|NCT01075399|Drug|[F 18]HX4|Approximately forty (40) patients who have diagnosis confirmed by histopathological examination of tumor tissue from head/neck, lung, liver, rectal or cervical cancers and will receive chemotherapy, radiation therapy or chemoradiotherapy, will be imaged under PET/CT with [F 18]HX4
16241255|NCT01075347|Other|autologous serum|with postoperative 20% autologous serum diluted with preservative-free artificial tear application bi-hourly during waking hours
16241256|NCT01075347|Other|Non-autologous serum|without postoperative 20% autologous serum diluted with preservative-free artificial tear application bi-hourly during waking hours
16241257|NCT01075334|Dietary Supplement|Porimore - A Carnitine based food supplement|A daily dose of 2 grams L-carnitine, 1 gr acetyl L-carnitine, 500mg Vitamin C, 400 IU vitamin E, 60 mg Q10, 30mg Zinc Picolinate, 500mcg Folic Acid, 200 Mcg Selenium, 100 MCG Vitamin B12.
16241258|NCT01075334|Dietary Supplement|Zinc and Folate Supplementation|500 Mcg Folic acid, 30-60 mg Zinc tablets/ day
16241259|NCT01075321|Drug|everolimus|Given orally
16241260|NCT01075321|Drug|lenalidomide|Given orally
16241261|NCT01075321|Other|laboratory biomarker analysis|Correlative studies
16241262|NCT01075321|Genetic|polymorphism analysis|Correlative studies
16241263|NCT01075321|Other|immunohistochemistry staining method|Optional correlative studies
16241264|NCT01075321|Genetic|microarray analysis|Optional correlative studies
16241265|NCT01075321|Genetic|fluorescence in situ hybridization|Optional correlative studies
16241266|NCT01075308|Drug|HDAC inhibitor SB939|SB939 given orally every other day 3 times a week (i.e. Monday /Wednesday /Friday, or Tuesday /Thursday / Saturday) for 3 consecutive weeks followed by one week off-dosing. A treatment cycle is 4 weeks (28 days).
16241267|NCT01075295|Behavioral|Behavioural Intervention for the Prevention of Weight Gain|"The intervention consists of four steps:
~STEP 1 (Watchful Waiting): Measurement of body weight and Waist Circumference at the start (1 visit). Subjects that have a weight gain greater then or equal to 2% of their baseline weight will progress to Step 2
~STEP 2 (Self monitoring): Self-monitoring of daily weight, daily food intake & physical activity (1 visit) Subjects that have a weight gain greater then or equal to 2% (from STEP 2) will progress to Step 3
~STEP 3 (Nutrition & Exercise Counseling): Counseling for nutrition and physical activity (4 visits; 2 in-clinic, 2 telephone) Subjects that have a weight gain greater then or equal to 2% (from STEP 3) will progress to Step 4
~STEP 4 (Intensive): Intensive behavioral training geared towards reducing caloric intake (4 in-clinic visits)"
16241268|NCT01075295|Other|TAU|Treatment as provided by individuals' existing healthcare providers
16241269|NCT01075282|Drug|Insulin Glargine|
16241270|NCT01075282|Drug|LY2189265|
16241271|NCT01075282|Drug|Metformin|
16241272|NCT01075282|Drug|Glimepiride|
16241273|NCT01075256|Device|5% calcium sodium phosphosilicate toothpaste|Low concentration calcium sodium phosphosilicate tubule occlusion agent
16241274|NCT01075256|Device|7.5% calcium sodium phosphosilicate toothpaste|High concentration calcium sodium phosphosilicate tubule occlusion agent
16241275|NCT01075256|Device|Placebo toothpaste|Placebo toothpaste
16241276|NCT01075243|Drug|Paracetamol 1000 mg|Paracetamol 1000mg
16241277|NCT01075243|Drug|Paracetamol 650 mg|Paracetamol 650 mg
16241278|NCT01075243|Drug|Placebo|Placebo
16241279|NCT01075230|Procedure|Total knee arthroplasty|Subject will undergo total knee arthroplasty according to established surgeon / hospital protocol.
16241280|NCT01075217|Drug|iopamidol|Participants received at least one intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
16241332|NCT01074827|Other|Strength training and treadmill training|Eight weeks of intensive strength training or treadmill training
16241281|NCT01075217|Drug|iodixanol|Participants received at least one intraarterial injection in one of the following 3 locations: aortic bifurcation (total volume 15-20 mL), iliac arteries (total volume 10-12 mL), or superficial femoral artery (total volume 8-12 mL to view only thigh, 10-15 mL to view calf as well, 20 mL for full runoff to foot).
16241282|NCT01075204|Drug|clarithromycin modified release 500 mg|clarithromycin modified release 500 mg for 7 days
16241283|NCT01075165|Other|silicone spray|application of silicone spray to predefined area qd 12 weeks
16241284|NCT01075165|Other|saline spray|application of saline spray to predefined area qd 12 weeks
16241285|NCT01075152|Drug|efavirenz|Treatment strategy of when to initiate first line HIV therapy after cryptococcal meningitis diagnosis.
16241286|NCT01075152|Biological|nucleoside|Treatment strategy of when to initiate first line HIV therapy after cryptococcal meningitis diagnosis.
16241287|NCT01075139|Behavioral|Brief Motivational Intervention|30 minute one-on-one meeting
16241288|NCT01075139|Behavioral|Educational information|Educational handouts/brochures
16241289|NCT01075126|Drug|Depakote|
16241290|NCT01075126|Drug|Lithium|
16241291|NCT01075113|Drug|sorafenib tosylate|Given orally
16241292|NCT01075113|Drug|vorinostat|Given orally
16241293|NCT01075100|Drug|Ixabepilone|20 mg/m2 on Days 1 and 8
16241294|NCT01075100|Drug|Carboplatin|carboplatin AUC=2.5 on Days 1 and 8
16241295|NCT01075087|Drug|Placebo|Bilateral TAP block using sterile normal saline.
16241296|NCT01075087|Drug|(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.|(study group) will receive a bilateral TAP block using 20 cc of 0.5% ropivacaine on each side.
16241297|NCT01075074|Procedure|Transversus abdominis plane block|A regional block performed in the transversus abdominis plane of the abdomen, used to provide anesthesia and analgesia for the abdominal region.
16241298|NCT01075061|Other|healthy volunteers|morphological and functional brain MRI; transcranial magnetic stimulation
16241299|NCT01075061|Other|Kallmann|morphological and functional brain MRI; transcranial magnetic stimulation
16241300|NCT01075061|Other|Congenital Mirror Movement|morphological and functional brain MRI; transcranial magnetic stimulation
16241301|NCT01075048|Drug|Tivantinib|ARQ 197 is supplied as a 120-mg capsule, administered twice daily at the dose determined in the Phase 1 portion of the study. Administered until disease progression, unacceptable toxicity or other discontinuation criteria is met.
16241302|NCT01075048|Drug|Placebo|Placebo to match ARQ 197, administered twice daily. Administered until disease progression, unacceptable toxicity or other discontinuation criteria is met.
16241303|NCT01075048|Drug|Cetuximab|Cetuximab 500 mg/ m^2 intravenous infusion over 120 minutes at the first cycle, then over 60-minutes at subsequent cycles. Administered on Day 1 and Day 15 of each 28 day cycle. Administered until disease progression, unacceptable toxicity or other discontinuation criteria is met.
16241304|NCT01075048|Drug|Irinotecan|60 minutes after cetuximab, Irinotecan 180 mg/m^2 intravenous infusion over 30 - 90 minutes. Administered on Day 1 and Day 15 of each 28 day cycle. Administered until disease progression, unacceptable toxicity or other discontinuation criteria is met.
16241305|NCT01075022|Drug|Colecalciferol (Vitamin D3) 300.000 UI|Colecalciferol (Vitamin D3) 300.000 UI Capsule, Single Dose
16241306|NCT01075022|Drug|Placebo|Placebo Capsule, Single Dose
16241307|NCT01074996|Drug|S-1|40-60mg bid , days 1-14, every 3 weeks
16241308|NCT01074996|Drug|S-1 plus Leucovorin|S-1 40-60mg bid, days 1-14 , every 3 weeks Leucovorin 25mg bid , days 1-14 , every 3 weeks
16241309|NCT01074970|Drug|Cisplatin|Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles
16241310|NCT01074970|Drug|Rucaparib|Rucaparib 24mg C1,30mg C2-4, D1,2,3 every 21 days for 4 cycles
16241311|NCT01074970|Drug|Cisplatin|Cisplatin 75 mg/m2 IV infusion over 60 minutes, D1 every 21 days for 4 cycles
16241312|NCT01074957|Device|Incentive Spirometry|Incentive Spirometry (IS) has been used extensively in postoperative period and consists of spontaneous deep breaths through a device which provides a visual feedback to maintain a maximum insuflation
16241313|NCT01074957|Device|Breath-Stacking Technique|An one-way valve device to promote the summation of successive inspiratory volumes while expiration was avoided
16241314|NCT01074957|Other|Exercise|Patients were taught huffing (forced expiration while the glottis is opened), supported cough (with patient's hands placed on the sternotomy incision) and mobilization, including active limb exercises, sit out of bed and deambulation (starting on the third postoperative day).
16241315|NCT01074944|Drug|Eliglustat tartrate|Oral Capsule in 50 mg or 100 mg dosages
16241316|NCT01074931|Drug|Lopinavir/ritonavir (Kaletra)|"Lopinavir/ritonavir(LPV/r) is an HIV protease inhibitor (PI) that is co-formulated with lopinavir and ritonavir. Lopinavir is an inhibitor of the HIV-1 and HIV-2 proteases. As co-formulated in LPV/r, ritonavir inhibits the CYP3A-mediated metabolism of lopinavir, thereby providing increased plasma levels of lopinavir.
~The assignment of the patient to a lopinavir/ritonavir - containing regimen is not decided in advance by this protocol but falls within current practice and the prescription of lopinavir/ritonavir is clearly separated from the decision to include the patient in this study."
16241317|NCT01074918|Drug|Potassium, Magnesium, Citrate|Potassium MAgnesium Citrate - 30 mEq potassium, 15 mEq Magnesium, 45 mEq Citrate in a powder mixture twice a day, mixed with a glass of water.
16241318|NCT01074918|Drug|Potassium Chloride|Potassium Chloride
16241319|NCT01074905|Drug|Artesunate|2 mg/kg/day as single daily dose given for 5 days; maximum dose range is 1.6 to 2.4 mg/kg/day or a total of 8 to 12 mg/kg.
16241320|NCT01074905|Drug|Chloroquine|25 mg base/kg given in divided doses (10,10,5) over 3 days; Absolute range 20-30 mg/kg.
16241321|NCT01074905|Drug|Chloroquine/Primaquine|Chloroquine 3 days and Primaquine 14 days
16241322|NCT01074892|Drug|Provera (medroxyprogesterone/progestin)|10 mg tablet, 1 tablet per day taken 10 days per month Duration is 6 months
16241323|NCT01074892|Drug|Provera (medroxyprogesterone)|10 mg per oral tablet. One tablet per day for 6 months
16241324|NCT01074892|Device|Mirena (levonorgestrel)|Inserted in the uterine cavity and kept in situ for 6 months
16241325|NCT01074879|Dietary Supplement|Whey protein|Dietary supplement after training
16241326|NCT01074879|Dietary Supplement|Milk protein|Dietary supplement after training
16241327|NCT01074879|Dietary Supplement|Carbohydrates|Dietary supplement after training
16241333|NCT01074814|Drug|(will be assigned based on molecular profile and RPMA)|treatment will be assigned based on IHC< FISH, DNA microarray and RPMA results
16241334|NCT01074801|Other|Closed-loop insulin delivery|Basal subcutaneous insulin delivery to be adjusted at 15min cycles according to the computer-based algorithm advice.
16241335|NCT01074801|Other|Standard insulin pump treatment|Subcutaneous insulin delivery to be performed based on subjects' standard treatment
16241336|NCT01074788|Behavioral|mind body therapy|mind-body therapy includes guided imagery, relaxation techniques, mediation and touch therapy.
16241337|NCT01074775|Biological|Gut infection challenge with M bovis|Oral delivery of 100mg viable M bovis (approximately 10,000,000 viable bacilli) in 5mL 1.5% sodium glutamate solution on three occasions on days 0, 28 and 49
16241338|NCT01074762|Behavioral|Structured personal care|General practitioners (GPs) were recommended to perform regular follow up every three months and an annual screening for diabetic complications. The GP was requested to define, together with the patient, the best possible goals for blood glucose concentration, glycated haemoglobin (HbA1c), diastolic blood pressure, and lipids within three predefined categories. At each quarterly consultation, the GP was asked to compare the achievements with the goal and consider changing either goal or treatment accordingly. The doctors received annual descriptive feedback reports on individual patients. The GPs were introduced to possible solutions to therapeutic problems through clinical guidelines supported by an annual half day seminar. Patient leaflets were produced for the doctor to hand out.
16241339|NCT01074749|Device|Accent Pacemaker|Implantation of pacemaker
16241340|NCT01074723|Dietary Supplement|b-cryptoxanthin and phytosterols|Fruit juices containing b-cryptoxanthin (ca. 1 mg), phytosterols (ca 1.7g) or both will be consumed for 4 weeks with a 4-week washout in between.
16241341|NCT01074710|Drug|[2-13C] uracil|po, in the form of semi-solid meal, granules, once a period
16241342|NCT01074710|Drug|[2-13C] uracil, placebo|po, in the form of semi-solid meal, granules, once a period
16241343|NCT01074697|Drug|Fosaprepitant dimeglumine|Addition of fosaprepitant dimeglumine 150 mg IV single dose weekly (before chemotherapy) to dexamethasone and palonosetron.
16241344|NCT01074697|Drug|Placebo|Saline water
16241345|NCT01074671|Device|CG Future Annuloplasty Ring/Band|A CG Future Annuloplasty Ring or Band will be implanted, following standard care
16241346|NCT01074658|Device|Medtronic CoreValve System|Transcatheter Aortic Valve Implantation of the Medtronic CoreValve System
16241347|NCT01074645|Drug|Tenofovir disoproxil fumarate (TDF)|Tenofovir 300mg/day for 3 month
16241348|NCT01074632|Drug|Lurasidone HCl|
16241349|NCT01074619|Drug|Memantine|5 mg the first week, then 10 mg the second week, 15 mg the third week and finally 20 mg the fourth week until the end of the study (t0 + 1 year)
16241350|NCT01074619|Drug|Placebo|5 mg the first week, then 10 mg the second week, 15 mg the third week and finally 20 mg the fourth week until the end of the study (t0 + 1 year)
16241351|NCT01074606|Device|AcrySof Toric Intraocular Lens|Implantation of the AcrySof Toric Intraocular Lens (IOL)
16241352|NCT01074593|Biological|Interferon beta-1a|12.000UI - single dose
16241353|NCT01074593|Biological|Interferon beta-1a|12.000UI - Single dose
16241354|NCT01074567|Drug|DMSO cocktail|intra-vesical: DMSO 50% in 50 cc water for injection 10 cc heparin 5000 IU hydrocortisone 100 mg bupivacaine 0.125%
16241355|NCT01074554|Drug|Antibiotic Regimen|Levaquin 750 mg loading on day 1, then 500 mg po QD Ethambutol 15-25 mg/kg for a maximum of 1200mg QD Azithromycin 500mg on day 1, then 250 mg po QD Rifampin 5-10 mg/kg for a maximum of 300mg po QD All four drugs are given concomitanly
16241356|NCT01074554|Drug|Placebo Regimen|lactose control tablets; one for each antibiotic with equivalent pills
16241357|NCT01074541|Radiation|UVB|0.375 SED x 4 in a week
16241358|NCT01074541|Radiation|UVB|0.75 SED x 4 in a week
16241359|NCT01074541|Radiation|UVB|1.5 SED x 4 in a week
16241360|NCT01074541|Radiation|UVB|3.0 SED x 4 in a week
16241361|NCT01074528|Behavioral|mindfulness based stress reduction program|8-week mindfulness training program
16241362|NCT01074502|Drug|apremilast|apremilast 20 mgs orally twice a day for 12 weeks
16241363|NCT01074476|Dietary Supplement|Glucosamine sulphate|750mg glucosamine sulphate (oral tablets), twice per day for 3 months
16241364|NCT01074476|Other|Placebo|Placebo tablets, twice per day for 3 months
16241365|NCT01074463|Drug|Pramipexole Dihydrochloride|0.25 mg Tablet
16241366|NCT01074463|Drug|Pramipexole Dihydrochloride|0.25 mg Tablet
16241367|NCT01074450|Drug|Pramipexole Dihydrochloride|0.25 mg Tablet
16241368|NCT01074450|Drug|Pramipexole Dihydrochloride|0.25 mg Tablet
16241369|NCT01074437|Drug|Prednisolone (Corticosteroid)|Oral liquid prednisolone. Dose: 1-2mg/kg/day for 7 days, and then dose will be slowly reduced and then stopped after 3 weeks.
16241370|NCT01074437|Drug|Propranolol|Oral liquid propranolol will be dosed Oral liquid propranolol will be dosed at 2 mg/kg/day.
16241371|NCT01074437|Drug|Placebo|Liquid placebo will be given during the two month treatment trial.
16241372|NCT01074424|Genetic|proteomic profiling|
16241373|NCT01074424|Other|laboratory biomarker analysis|
16241374|NCT01074411|Drug|Bortezomib|Given IP
16241375|NCT01074411|Drug|Carboplatin|Given IP
16241376|NCT01074411|Other|Laboratory Biomarker Analysis|Correlative studies
16241377|NCT01074411|Other|Pharmacological Study|Correlative studies
16241378|NCT01074398|Genetic|gene expression analysis|
16241379|NCT01074398|Genetic|polymorphism analysis|
16241380|NCT01074398|Genetic|protein expression analysis|
16241381|NCT01074398|Other|immunohistochemistry staining method|
16241382|NCT01074398|Other|laboratory biomarker analysis|
16241383|NCT01074385|Behavioral|Dignity Therapy|Dignity therapy is a psychotherapeutic intervention developed to address psychosocial and existential distress among terminally ill patients. Basically, it invites patients to discuss topics that matter most or how they want to be remembered. This interview is recorded and then edited and returned to the patient to be used for further reflection or for sharing with loved ones.
16241384|NCT01074372|Drug|REGN727|4 cohorts (dose 1, 2, 3, 4)
16241385|NCT01074372|Drug|Placebo|4 cohorts (dose 1, 2, 3, 4)
16241386|NCT01074359|Drug|A0001 (alpha-tocopherolquinone)|28 days (1.5 g total daily dose) oral A0001 capsules. Treatment taken twice daily with meals.
16241389|NCT01074333|Drug|Cetuximab|In subjects with mCRC, cetuximab will be used in combination with chemotherapy or as a single agent according to the approved national label as in routine clinical practice. The initial dose of Erbitux is 400 mg/m2 body surface area and the subsequent weekly doses are 250 mg/m2 each administered i.v. via in-line filtration with an infusion pump, gravity drip, or a syringe pump. The recommended infusion period for the initial dose is 120 minutes and for the subsequent weekly doses is 60 minutes with the maximum infusion rate not exceeding 5 ml/min.
16241390|NCT01074320|Other|Other|Observational study
16241391|NCT01074307|Drug|Low Dose Bisoprolol|Bisoprolol tablet (Concor) will be administered orally at a starting dose of 1.25 milligram (mg) once daily for 2 weeks. The dose will be further escalated from 1.25 mg to 2.5 mg once daily after 2 weeks and will be administered up to 26 weeks, only if the previous administered dose is well tolerated. If the subject could not tolerate the increased dose, then the last tolerated dose will be maintained up to 26 weeks.
16241392|NCT01074307|Drug|High Dose Bisoprolol|Bisoprolol tablet (Concor) will be administered orally at a starting dose of 3.75 mg once daily for 2 weeks. The dose will be subsequently increased to 5 mg, 7.5 mg, or 10 mg once daily every two weeks and will be administered up to 26 weeks, only if the previous administered dose is well tolerated. If the subject could not tolerate the increased dose, then the last tolerated dose will be maintained up to 26 weeks.
16241393|NCT01074294|Drug|OPDC-34712 + Stimulant Therapy|Tablets, Oral, 0.25 or 1.0 mg OPDC-34712 and FDA approved stimulant therapy
16241394|NCT01074294|Drug|Placebo + Stimulant Therapy|Placebo plus a FDA approved stimulant therapy
16241395|NCT01074281|Drug|Enalapril maleate (10 mg) + nitrendipine (20 mg)|The drug was administered as per the Summary of Product Characteristics (SPC)
16241396|NCT01074268|Drug|insulin degludec|Injected s.c. (under the skin) once daily. Dose was individually adjusted.
16241397|NCT01074268|Drug|insulin detemir|Injected s.c. (under the skin) once daily or twice daily (BID). Dose was individually adjusted.
16241398|NCT01074268|Drug|insulin aspart|Injected s.c. (under the skin) as mealtime insulin. Dose was individually adjusted.
16241399|NCT01074255|Drug|EMEND|EMEND (Aprepitant,125 mg oral capsules) is administered 1 hour prior to chemotherapy on treatment Day 1. EMEND (80 mg) is administered on the morning of Days 2 and 3. EMEND is concomitantly administered with a regimen of a corticosteroid and a 5-HT3 antagonist.
16241400|NCT01074229|Drug|Placebo|placebo injection
16241401|NCT01074229|Drug|Drug .5% Ropivacaine|.5% ropivacaine 20 mls on each side of abdomen
16241402|NCT01074229|Drug|20 cc of 0.25% ropivacaine|Will receive a bilateral TAP block using 20 cc of 0.25% ropivacaine
16241403|NCT01074216|Drug|vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units)|Patients will be given vitamin D repletion with Cholecalciferol (vitamin D3 50,000 International Units) three times per week until the target vitamin D level of 40 ng/ml is achieved, and vitamin D3 maintenance initiated at 2,000 International Units daily thereafter.
16241404|NCT01074203|Drug|Nitazoxanide|"Drug administration: The drug will be available through the research pharmacy. Patients will receive 1000mg (2 tablets) oral NTZ or an equivalent dose of NTZ suspension 1500mg (75mL) according to the schedule below.
~Dose timing Dose Schedule Interval Dose Pre-transplant(on admission) 1000mg oral Once Total 1 dose Pre-transplant (delayed surgery >12 hours) 1000mg oral Every 12 hrs Variable Post operative dose 1000mg oral/ nasogastric tube Every 12 hrs Total 6 doses
~All attempts will be made to administer the tablet form of the medication, given the higher area under the curve that is achieved. If needed, the suspension formulation will be used. Since the suspension form has 70% bioavailability, the suspension dose administered will be 1.5 grams every 12 hours until the tablet form can be given."
16241405|NCT01074190|Drug|Group 1|A basal infusion rate for the PCEA will be set at 8 mL/h with patient administered boluses of 8 mL every 10 minutes and a one hour limit of 32 mL. Breakthrough pain in all groups will be managed using anesthesiologist administered boluses of bupivacaine 1.25 mg/mL without fentanyl.
16241406|NCT01074190|Drug|Group 2|A basal infusion rate for the PCEA will be set at 8 mL/h with patient administered boluses of 8 mL every 10 minutes and a one hour limit of 32 mL. Breakthrough pain in all groups will be managed using anesthesiologist administered boluses of bupivacaine 1.25 mg/mL without fentanyl.
16241407|NCT01074190|Drug|Group 3|A basal infusion rate for the PCEA will be set at 8 mL/h with patient administered boluses of 8 mL every 10 minutes and a one hour limit of 32 mL. Breakthrough pain in all groups will be managed using anesthesiologist administered boluses of bupivacaine 1.25 mg/mL without fentanyl.
16241408|NCT01074177|Drug|BIBW 2992|Taken orally once a day
16241409|NCT01074164|Other|Standard-of-care treatment for AD|Subjects will receive standard of care treatment for atopic dermatitis, including moisturizers and topical corticosteroids, per their dermatologist.
16241410|NCT01074164|Device|Accu-patch pellet|The accu-patch pellets will be applied to the LI11 pressure point, located on the left arm lateral to the antecubital fossae, for 10 minutes, 3 times a week for 1 month.
16241411|NCT01074151|Drug|duloxetine|any exposure to duloxetine that occurred during pregnancy
16241412|NCT01074138|Drug|KX2-391|KX2-391 will be administered as a 40 mg oral dosing solution, twice daily, for 6 28-day cycles.
16241413|NCT01074125|Drug|ferric citrate|1, 6, or 8 g/day taken within 1 hour of meals or snacks daily for 28 days
16241414|NCT01074112|Device|EFAST exam|Ultrasound of the heart, morisons pouch, pelvis, spleen and both lungs
16241415|NCT01074112|Device|Pelvic Ultrasound|Ultrasound view of the pelvis. including the bladder and uterus
16241416|NCT01074112|Procedure|Ultrasound Guided Vascular Access|Use of the ultrasound machine to identify a usable vein and guide the needle into the vein. After cannulation ultrasound is used to determine correct placement and identify extravasation.
16241417|NCT01074112|Device|Focused Ultrasound Scan|Use of ultrasound to identify and measure structures in the abdomen, thorax, retroperitoneum, or other necessary places.
16241418|NCT01074112|Device|Cardiac Ultrasound|Ultrasound views of the heart
16241419|NCT01074099|Biological|BMAC|Injection of BMAC into ischemic myocardium during CABG
16241420|NCT01074099|Procedure|CABG only|Control subjects will undergo CABG surgery without BMAC injection
16241421|NCT01074086|Drug|RAD 001|RAD 001 in steps of 3 patients from 10mg in day 1 and day 7 to 50 mg
16241501|NCT01073540|Drug|Cephalexin suspension (Optocef, BAYO5448)|Single dose of 500 mg / 10 mL
16241502|NCT01073540|Drug|Cephalexin suspension (Keflex)|Single dose of 500 mg / 20 mL
16241422|NCT01074073|Drug|Lurasidone HCl|"lurasidone HCl 40 mg tablets administered orally as three tablets (120 mg) once a day (QD).
~Lithium 300 mg capsules administered orally as two capsules (600 mg) twice a day (BID).
~On dosing days, breakfast will be served 30 minutes prior to the planned dosing time. Patients must consume the breakfast within 30 minutes or less. Dosing will take place 30 minutes after the start of breakfast."
16241423|NCT01074060|Drug|plerixafor|Given IV
16241424|NCT01074060|Biological|filgrastim|Given SC
16241425|NCT01074060|Drug|cyclophosphamide|Given IV
16241426|NCT01074060|Procedure|autologous hematopoietic stem cell transplantation|autologous hematopoietic stem cell transplantation
16241427|NCT01074060|Other|laboratory biomarker analysis|Correlative studies
16241428|NCT01074047|Drug|Azacitidine|75 mg/m^2 subcutaneous (SC) daily for 7 days for 28 day cycles until disease progression or unacceptable toxicity
16241429|NCT01074047|Drug|Conventional Care Regimen|"Physician pre-selects prior to randomization from one of the following:
~Intensive chemotherapy (cytarabine 100-200 mg/m^2 continuous intravenous infusion for 7 days + anthracycline IV x 3 days) + Best Supportive Care; induction with up to 2 consolidation cycles
~Low-dose cytarabine 20 mg subcutaneous (SC) twice a day (BID) for 10 days, for 28 day cycles + BSC; until disease progression or unacceptable toxicity
~Best Supportive Care only; until study end"
16241430|NCT01074034|Device|AV Therapy Assessment-B301 investigational device|Atrial and ventricular tachyarrhythmia therapy delivered by the B301 investigational device
16241431|NCT01074021|Drug|Nimotuzumab|"Nimotuzumab:(200mg/w,weekly, 7-8 weeks, one week before radiotherapy)
~Radiotherapy:
~IMRT: Nasopharynx: GTV 66-78. 2Gy,CTV1 60-64Gy,CTV2 54-60Gy.30-34 times, 2.20-2.30Gy/time,once a day, 5 days/w, 6-7 weeks. Neck: lymph node positive, GTVn 60-70Gy, once a day, 5 days/w, 6-7weeks; lymph node negative, CTVn50-55Gy, once a day, 5 days/w, 6-7 weeks.
~CRT: Nasopharynx, 70-(76-80)Gy, 35-(38-40)times, 2Gy/time, once a day, 5 days/w, 6-8weeks. If disease residual when radiotherapy finished could increase the dose appropriate. Neck: lymph node positive, 64-70 Gy, 32-35 times, 2 Gy/time, once a day, 5 days/w, 6-7 weeks; lymph node negative, 50-56 Gy, 25-28 times,2 Gy/time, once a day, 5 days/w, 5-6weeks cisplatin
~Chemotherapy:
~Cisplatin (100 mg/m2,1 time/21d, 3 times，on days 2, 23, 44 during the radiotherapy)"
16241432|NCT01074021|Drug|placebo plus chemoradiotherapy|"Placebo treatment:4 bottles/w,weekly, 7-8 weeks, one week before radiotherapy
~Radiotherapy:
~IMRT: Nasopharynx: GTV 66-78. 2Gy,CTV1 60-64Gy,CTV2 54-60Gy.30-34 times, 2.20-2.30Gy/time,once a day, 5 days/w, 6-7 weeks. Neck: lymph node positive, GTVn 60-70Gy, once a day, 5 days/w, 6-7weeks; lymph node negative, CTVn50-55Gy, once a day, 5 days/w, 6-7 weeks.
~CRT: Nasopharynx, 70-(76-80)Gy, 35-(38-40)times, 2Gy/time, once a day, 5 days/w, 6-8weeks. If disease residual when radiotherapy finished could increase the dose appropriate. Neck: lymph node positive, 64-70 Gy, 32-35 times, 2 Gy/time, once a day, 5 days/w, 6-7 weeks; lymph node negative, 50-56 Gy, 25-28 times,2 Gy/time, once a day, 5 days/w, 5-6weeks cisplatin
~Chemotherapy: Cisplatin (100 mg/m2,1 time/21d, 3 times，on days 2, 23, 44 during the radiotherapy)"
16241433|NCT01074008|Drug|ABT-450|50 mg capsules co-administered with ritonavir
16241434|NCT01074008|Drug|ABT-072|50 mg tablet
16241435|NCT01074008|Drug|ABT-333|400 mg tablet
16241436|NCT01074008|Drug|Ritonavir|100 mg capsules co-administered with ABT-450
16241437|NCT01074008|Drug|Peginterferon alpha-2a|Syringe, 180 µg/0.5 mL for subcutaneous injections
16241438|NCT01074008|Drug|Ribavirin|200 mg tablet dosed at 1000 or 1200 mg daily divided twice a day
16241439|NCT01074008|Other|Placebo|Matching placebo for ABT-450/r, ABT-072, or ABT-333 monotherapy at each dose level
16241440|NCT01073995|Drug|Kenalog and Sensorcaine|Kenalog: 40 mg/ml Sensorcaine 0.25%: 1cc
16241441|NCT01073982|Dietary Supplement|tart cultivar Montmorency cherry juice|21 ounces of experimental or placebo juice, consumed daily for 21 days.
16241442|NCT01073969|Other|wheat bran extract|Comparison of control cereal (containing no added wheat bran extract)to two test cereals containing different amounts of added wheat bran extract
16241443|NCT01073969|Other|control wheat bran extract|Comparison of control cereal (containing no added wheat bran extract) to two test cereals containing different amounts of added wheat bran extract
16241444|NCT01073956|Procedure|Medium-wave 448 kHz therapy|0.5 MHz radiofrequency for 10 minutes. At SPS insertion and bicipital groove
16241445|NCT01073956|Procedure|Ultrasonic therapy|Pulsed 1 MHz ultrasound at 2 W/cm2 for 10 minutes. At SPS insertion and bicipital-groove
16241446|NCT01073956|Procedure|Inactive electrotherapy|Inactive electrotherapy, inactive head, dosage 0 W/cm2 for 10 minutes. At SPS insertion and bicipital groove.
16241447|NCT01073943|Drug|PicoPrep|PicoPrep (sodium picosulfate, magnesium oxide and citric acid) powder for oral solution consisted of 2 pouches of powder administered in a divided dose. Each PicoPrep pouch was reconstituted by mixing the contents in a cup with 5 ounces of cold water. Subjects randomized to the PicoPrep group will begin treatment (1st sachet) one day before colonoscopy between 4:00 and 6:00 PM, and will complete the treatment (2nd sachet) at least 6 hours later, between 10:00 PM and 12:00 AM. Subjects will consume approximately (5) 8 oz. glasses of clear liquids following the first sachet administration in the afternoon and (3) 8 oz. glasses of clear liquids following the second sachet administration in the evening, one day before colonoscopy.
16241448|NCT01073943|Drug|HalfLytely|HalfLytely contains polyethylene glycol electrolyte solution (PEG-EL), sodium chloride, sodium bicarbonate and potassium chloride. The day prior to the colonoscopy procedure and after the first bowel movement or after 6 hours following administration of the bisacodyl tablets, whichever occurred first, subjects were to drink the 2 liter HalfLytely at a rate of one 8-ounce glass every 10 minutes. The entire solution was to be consumed.
16241449|NCT01073943|Drug|bisacodyl|Two 5 mg bisacodyl tablets were taken in the afternoon on the day prior to the colonoscopy procedure.
16241450|NCT01073930|Drug|PicoPrep|PICOPREP (sodium picosulfate, magnesium oxide and citric acid) powder for oral solution consisted of 2 pouches of powder administered in a divided dose. Each PICOPREP pouch was reconstituted by mixing the contents in a cup with 5 ounces of cold water. The first pouch was taken between 5:00 PM and 9:00 PM the evening prior to the colonoscopy procedure. Subjects were to consume five (5) 8-ounce glasses of clear liquids over the next few hours. The second pouch was taken approximately 5 hours before but no more than 9 hours prior to the colonoscopy procedure. Subjects were to consume three (3) 8-ounce glasses of clear liquids.
16241503|NCT01073527|Drug|hypertonic saline-salbutamol combination|hypertonic saline 5% with 0.5cc salbutamol
16241504|NCT01073527|Drug|Normal saline-salbutamol combination|normal saline - 4cc with salbutamol 0.5cc
16241451|NCT01073930|Drug|HalfLytely|HalfLytely contains polyethylene glycol electrolyte solution (PEG-EL), sodium chloride, sodium bicarbonate and potassium chloride. The day prior to the colonoscopy procedure and after the first bowel movement or after 6 hours following administration of the bisacodyl tablets, whichever occurred first, subjects were to drink the 2 liter HalfLytely at a rate of one 8-ounce glass every 10 minutes. The entire solution was to be consumed.
16241452|NCT01073930|Drug|bisacodyl|Two 5 mg bisacodyl tablets were taken in the afternoon on the day prior to the colonoscopy procedure.
16241453|NCT01073917|Other|Spontaneous Breathing|
16241454|NCT01073917|Other|Pressure Controlled Ventilation|
16241455|NCT01073917|Other|Pressure Support Ventilation|
16241456|NCT01073904|Drug|Levonorgestrel Emergency Pill (BAY86-5028)|Single dose of 1.5 mg coated tablet
16241457|NCT01073904|Drug|Postinor 2|Single dose of 1.5 mg tablet
16241458|NCT01073891|Drug|Moxifloxacin (Avelox, BAY12-8039)|Single oral dose of moxifloxacin (Avelox, BAY12-8039) IR (immediate release) tablet 400 mg under fasting conditions
16241459|NCT01073891|Drug|Moxifloxacin (BAY12-8039)|Single oral dose of moxifloxacin (BAY12-8039) oral suspension 400 mg under fasting conditions
16241460|NCT01073891|Drug|Moxifloxacin (BAY12-8039)|Single oral dose of moxifloxacin (BAY12-8039) oral suspension 400 mg under fed conditions
16241461|NCT01073878|Device|Athena Pelvic Muscle Trainer|The Athena PMT is a vaginally inserted electrical stimulator that induces the pelvic floor muscles to contract and relax, similar to Kegel exercises intended to strengthen the pelvic floor muscles.
16241462|NCT01073865|Drug|ZD9393 (Zoladex) 10.8 mg|10.8 mg (goserelin acetate): one subcutaneous depot injection once every 12 weeks (± 7 days).
16241463|NCT01073865|Drug|ZD9393 (Zoladex) 3.6 mg|3.6 mg (goserelin acetate): one subcutaneous depot injection once every 4 weeks (± 7 days).
16241464|NCT01073852|Drug|Placebo|Placebo pill, 1 pill orally twice daily for 9 weeks.
16241465|NCT01073852|Drug|Hydroxychloroquine|Patients will be taking hydroxychloroquine 200mg orally twice/daily.
16241466|NCT01073839|Drug|Cisplatin and Gemcitabine|Cisplatin 25 mg/m2 days 1 and 8; next cycle starting day 22. Gemcitabine 1000 mg/m2 days 1 and 8; next cycle starting day 22. Total of 8 cycles.
16241467|NCT01073826|Behavioral|Sport|
16241468|NCT01073826|Drug|Tocilizumab|
16241469|NCT01073826|Drug|Sitagliptin|
16241470|NCT01073813|Drug|Minocycline|100mg twice daily
16241471|NCT01073800|Drug|atorvastatin 80 mg per os daily|atorvastatin 80 mg per os daily
16241472|NCT01073800|Drug|placebo|placebo
16241473|NCT01073787|Drug|Normal saline|10 ml/kg of normal saline will be administered over 30 minutes
16241474|NCT01073774|Behavioral|Side by side|
16241475|NCT01073774|Behavioral|couples control condition|
16241476|NCT01073761|Drug|darunavir/ritonavir then atazanavir/ritonavir|"Phase 1: Oral darunavir/ritonavir 800/100 mg once daily for 10 days
~Phase 2: Oral atazanavir/ritonavir 300/100 mg once daily for 10 days"
16241477|NCT01073748|Drug|paracetamol|single dose of paracetamol 15mg/kg.
16241478|NCT01073722|Device|Placement of double lumen tube for one-lung ventilation|The gold standard for lung isolation is the use of a double lumen tube (DLT). A DLT is a bifurcated tube with a bronchial and a tracheal lumen.
16241479|NCT01073722|Device|Placement of EZ- Blocker for one-lung ventilation|Bronchial blockers are balloon-tipped semi-rigid catheters. Different types are available. They are not easy to put in position and frequently dislocates during repositioning of the patient or during surgical manipulation. To solve these problems, a novel type of bronchus blocker, i.e. the EZ- Blocker® is developed. The EZB is also a semi-rigid catheter but it has two distal extensions, both with an inflatable cuff and a central lumen. These improvements owe to the fact that the blocker anchors itself on the carina with the two extensions.
16241480|NCT01073709|Drug|Acetaminophen|
16241481|NCT01073696|Drug|granisetron IV|IV
16241482|NCT01073696|Drug|granisetron patch|patch
16241483|NCT01073683|Procedure|laryngoscopy|Treatment of advanced larynx cancer with induction TPF, in order to decide between chemoradiation and laryngeal preservation surgery
16241484|NCT01073683|Drug|Taxotere (Docetaxel), Cisplatin, 5FU|Taxotere 75 mg/m2 D1, Cisplatin 75 mg/m2 D1, 5FU 750 mg/m2 D1-4
16241485|NCT01073670|Drug|Indomethacin|Indomethacin was given via suppository at time of induction for anesthesia (2 x 50 mg) followed by one 50 mg suppository at 6, 12, 18 and 24 hours following cardiac bypass surgery.
16241486|NCT01073670|Drug|Acetaminophen & Indomethacin|Subjects were given a loading dose of acetaminophen (1300 mg) and indomethacin (50 mg)by suppository at the time of induction for anesthesia and then given 650mg acetaminophen + 25 mg indomethacin at 6, 12, 18 and 24 hours following cardiac bypass surgery.
16241487|NCT01073670|Drug|Acetaminophen|Subjects were given a loading dose of 2600 mg of acetaminophen (via suppository) at time of induction for anesthesia then given 1300mg at 6, 12, 18 and 24 hours following cardiac bypass surgery.
16241488|NCT01073657|Other|Supported Education|Rehabilitation counseling using peers to achieve educational goals
16241489|NCT01073657|Other|General Peer Support|Matched peer support for any personal goal other than education
16241490|NCT01073644|Drug|Sunitinib malate|sunitinib 50 mg, 4 weeks on, 2 weeks off
16241491|NCT01073631|Drug|voriconazole tablet|200 mg PO bid (orally, twice a day)
16241492|NCT01073618|Drug|voriconazole IV|6 mg/kg iv q 12 hours (loading) then maintenance
16241493|NCT01073605|Drug|Genotonorm|0.7 IU/kg/week or 0.03 mg/kg/day, daily subcutaneous injection
16241494|NCT01073605|Drug|Genotonorm|1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection
16241495|NCT01073605|Drug|Genotonorm|1.4 IU/kg/week or 0.06 mg/kg/day, daily subcutaneous injection Intermittent treatment (6 months with treatment and 6 months without)
16241496|NCT01073579|Drug|Sabril®|"Infantile Spasms (IS): Initiate therapy at 50 mg/kg/day twice daily increasing total daily dose per instructions to a maximum of 150 mg/kg/day.
~Refractory Complex Partial Seizures (rCPS) in Adults: Initiate therapy at 500 mg twice daily, increasing total daily dose per instructions. The recommended dose is 1.5 grams twice daily."
16241497|NCT01073566|Device|Finesse|Finesse Insulin Delivery Patch
16241498|NCT01073566|Device|Pen/Syringe (Usual injection device)|Pen/Syringe
16241499|NCT01073553|Drug|Cephalexin capsules (Optocef, BAYO5448 )|Single dose of 500 mg (One 500 mg capsule)
16241500|NCT01073553|Drug|Cephalexin capsules (Keflex)|Single dose of 500 mg (Two 250 mg capsules)
16241505|NCT01073501|Drug|Pregabalin|Pregabalin 25 mg (Lyrica; Pfizer, Germany) or placebo will be administered orally daily at the end of hemodialysis sessions in dialysis patients or every evening in non dialysis CKD patients. The dose will be increased up to 50 mg if no improvement of pruritus will be established at the end of first week of the study
16241506|NCT01073501|Drug|Placebo|Pregabalin 25 mg (Lyrica; Pfizer, Germany) or placebo will be administered orally daily at the end of hemodialysis sessions in dialysis patients or every evening in non dialysis CKD patients. The dose will be increased up to 50 mg if no improvement of pruritus will be established at the end of first week of the study
16241507|NCT01073488|Behavioral|Community Mobilization, HBLSS and facility improvement|Mobilization of the community, with special emphasis on pregnant women and their families, to identify resources and solutions to improve maternal and neonatal mortality, home-based life savings skills (HBLSS) for community birth attendants and facility improvement activities.
16241508|NCT01073475|Other|There is no intervention associated with this study.|There is no intervention associated with this study
16241509|NCT01073449|Procedure|In-hospital follow-up of cardiac device|Electrical measures taken during normal follow-up and clinical status of the patient
16241510|NCT01073436|Other|Discontinuation of therapy|Patients with chronic-phase chronic myeloid leukemia (CP-CML) previously treated with interferon-alpha (IFN) and presently on a tyrosine kinase inhibitor (TKI) (imatinib mesylate, dasatinib, or nilotinib) with achievement of a complete cytogenetic and at least a major molecular remission.
16241511|NCT01073423|Behavioral|Music Therapy|1-hour music therapy sessions, administered in group format 3 times per week for 8 weeks.
16241512|NCT01073423|Behavioral|Yoga|1-hour yoga sessions administered in group format 3 times per week for 8 weeks
16241513|NCT01073397|Behavioral|Yoga|Integral Yoga class (90 minutes per class), Once weekly for 10 weeks
16241514|NCT01073384|Drug|SGX201 (delayed release beclomethasone 17,21-dipropionate)|Delayed release beclomethasone 17,21-dipropionate before the first administration of radiation therapy continuing for 7 days after the end of radiation therapy.
16241515|NCT01073371|Drug|Prilocaine|1.8mL infiltration of liposome-encapsulated 3% prilocaine, 3% plain prilocaine or 3% prilocaine with 0,03IU/mL felypressin in the buccal sulcus of the maxillary right canine
16241516|NCT01073358|Procedure|Routine hilar lymphadenectomy|Hilar lymphadenectomy is performed before actual resection of the colorectal liver metastases
16241517|NCT01073345|Procedure|Portal venous pressure|Portal venous pressure is measured by invasive means using an arterial canula
16241518|NCT01073345|Procedure|Portal venous flow|Portal venous flow is measures using a noninvasive method (Doppler flow meter)
16241519|NCT01073345|Procedure|Hepatic artery flow|Hepatic artery flow will be measured using a noninvasive method (Doppler flow meter)
16241520|NCT01073332|Dietary Supplement|Arginine antioxidant supplements|The proprietary supplement Niteworks® was manufactured by Herbalife International Inc. (Century City, California, USA). Each serving contained 5.2g L-arginine in a proprietary blend with L-citrulline, 500mg ascorbic acid, 400IU vitamin E, 400ug folic acid, 300mg L-taurine, and 10mg alpha lipoic acid in a lemon-flavored powder form. One serving of supplement powder was mixed with 8 oz of water, administered at bedtime based on the rationale that nitric oxide levels are lowest during sleep due to inactivity, lack of food and low blood pressure.
16241521|NCT01073332|Dietary Supplement|Placebo|The placebo group received a powder with all active ingredients replaced with M-100 maltodextrin.
16241522|NCT01073319|Other|Placebo|Administration of placebo pill
16241523|NCT01073319|Drug|Rivastigmine|Participants will be randomized to rivastigmine (1.5 mg bid) for 6 days of each phase.
16241524|NCT01073319|Drug|Rivastigmine|Participants will be randomized to rivastigmine (3 mg bid) for 6 days of each phase.
16241525|NCT01073306|Biological|Investigational Vaccine for Dengue Virus Subtype 2|Subcutaneous injection in upper arm of vaccine at dose of 10 plaque-forming units (PFU)
16241526|NCT01073306|Other|Placebo|Subcutaneous injection of placebo
16241527|NCT01073293|Biological|V503 Vaccine|V503 (Multivalent HPV L1 VLP vaccine) given as a 0.5 mL intramuscular injection at Day 1, Month 2, and Month 6
16241528|NCT01073293|Biological|REPEVAX™ (Concomitant)|REPEVAX™ given as a single 0.5 mL intramuscular injection at Day 1
16241529|NCT01073293|Biological|REPEVAX™ (Non-concomitant)|REPEVAX™ given as a single 0.5 mL intramuscular injection at Month 1
16241530|NCT01073280|Procedure|cerebral flexible endoscopy|The investigators will make a burrhole in the precoronal suture introducing the flexible endoscope taking a cerebral and a basal meningeal biopsy
16241531|NCT01073267|Radiation|TSEBT|Total skin electron beam therapy (TSEBT) to a total dose of 12 Gray (TSEBT 12 Gy), low-dose radiation to the skin 4-5 days a week for 3 weeks.
16241532|NCT01073241|Procedure|transurethral ventral wall of urethra-preserving enucleation of prostate|The patients' ventral wall of the prostate urethra was preserved and enucleation of prostate was performed for the left hyperplasia in the envelop.
16241533|NCT01073241|Procedure|transurethral prostatic resection|The patients' prostate was resected with the conventional Nesbit TURP
16241534|NCT01073228|Drug|EVP-6124|
16241535|NCT01073228|Drug|Placebo|
16241536|NCT01073215|Behavioral|Family-Based Lifestyle Modification|The Self-Guided condition will receive the same manual content and recommendations for eating and physical activity as the Group Condition. Since this approach is primarily home-based, participants in this condition will also receive additional tips and guidelines to assist the family in following the program at home. There will be 6 visits with the health coach at weeks 01, 04, 08, 24, 40, and 52. Participants will receive 2 phone calls from health coach at weeks 16 and 32. Parents and teens will be encouraged to hold weekly meetings at home to discuss program goals and progress.
16241537|NCT01073215|Behavioral|Family-Based Lifestyle Modification Program|"The Group condition will consist of a comprehensive family based lifestyle modification program of 23 visits (8 weekly, 8 bi-weekly, 7 monthly).
~Intervention visits include a combination of 17 group sessions and 6 individual meetings with health coach. There will be 7 phone calls two weeks after each monthly visit. Adolescents and their parents attend concurrent group meetings. The content of the sessions will include topics related to nutrition, physical activity, and behavior modification for weight management."
16241538|NCT01073202|Drug|ursodeoxycholic acid|13-15mg/kg/day, 250mg/capsule, given twice per day, within the first 4 weeks after liver transplantation
16242039|NCT01069237|Device|OPTI-FREE RepleniSH|Multi-Purpose Solution for soft contact lenses
16241539|NCT01073202|Drug|identical-appearing placebo|13-15mg/kg/day, 250mg/capsule, given twice per day, within the first 4 weeks after liver transplantation
16241540|NCT01073189|Drug|Intra-Renal Fenoldopam|Placement of an intra-renal catheter for infusion of fenoldopam mesylate
16241541|NCT01073189|Drug|Furosemide|Patients randomized to the Diuretic Control group will receive intravenous furosemide as an active control
16241542|NCT01073176|Other|TEAMS (Training Attention Executive and Motor Skills)|Training Executive, Attention and Motor Skills (TEAMS) is a new research program for preschool children with Attention-Deficit/Hyperactivity Disorder (ADHD) that attempts to use game-like activities and physical exercise to promote the growth of neural processes that underlie the core features of the disorder (e.g., hyperactivity, impulsivity) as well as associated areas of difficulty (e.g., socialization, motor skills). These activities are implemented at home and in supervised playgroups at no cost to families and are coupled with extensive parental education about ADHD symptoms and associated impairments.
16241543|NCT01073163|Drug|Bendamustine|Bendamustine at 90 mg/m^2 IV on Days 1 and 2 of a 28-day cycle.
16241544|NCT01073163|Drug|Rituximab|Rituximab at 375 mg/m^2 IV on Day 1 of a 28-day cycle.
16241545|NCT01073150|Drug|Tea Tree Oil|Tea Tree Oil shampoo 0.25% and ointment 5% daily and Tea Tree Oil oily solution 50% once a week for six weeks
16241546|NCT01073124|Procedure|Saline Load Test|Intraarticular injection of dilute methylene blue dye (1 ml per 500 ml normal saline) or normal saline into the knee joint through a lateral suprapatellar injection site. Maximum injection of 180 ml.
16241547|NCT01073111|Device|zotarolimus-eluting stent (ENDEAVOR®)|zotarolimus-eluting stent
16241548|NCT01073111|Device|sirolimus-eluting stents (CYPHER SELECT® PLUS)|sirolimus-eluting stents
16241549|NCT01073111|Device|everolimus-eluting stents (PROMUS®)|everolimus-eluting stents
16241550|NCT01073098|Other|Vascular occlusion test|Reperfusion slope after vascular occlusion test
16241551|NCT01073085|Behavioral|"Web-based automated coaching by e-mails"|
16241552|NCT01073085|Behavioral|Self-help guide|
16241553|NCT01073072|Procedure|Conventional technique|Conventional technique to repair potentially contaminated incisional or abdominal wall hernias
16241554|NCT01073072|Procedure|Technique Tutomesh®|Technique of abdominal wall reconstruction or hernia repair strengthened by Tutomesh® in potentially contaminated environment.
16241555|NCT01073059|Drug|Valproic acid and Ertapenem|
16241556|NCT01073046|Device|Naso-Gastric/Jejunal Tube|Silastic Naso-Gastric/Jejunal Tube (Rusch® distributed by Teleflex Medical Srl)
16241557|NCT01073033|Dietary Supplement|milk supplement 1|milk supplement with probiotics
16241558|NCT01073033|Dietary Supplement|milk supplement 2|milk supplement without probiotics
16241559|NCT01073020|Device|Allergan Adjustable Gastric Band Surgery|
16241560|NCT01073020|Other|Intensive Medical Diabetes & Weight Management (Why WAIT) - Band Group|Intensive Medical Diabetes & Weight Management (Why WAIT) - Band Group
16241561|NCT01073020|Procedure|Roux-en-Y Gastric Bypass (RYGB) Surgery|
16241562|NCT01073020|Other|Intensive Medical Diabetes & Weight Management (Why WAIT) - Bypass Group|Intensive Medical Diabetes & Weight Management (Why WAIT) - Bypass Group
16241563|NCT01073007|Drug|Simvastatin|Simvastatin 40 mgrs daily for three months.
16241564|NCT01072994|Dietary Supplement|Fish Oil|Differential proportional doses of DHA versus DHA and EPA
16241565|NCT01072981|Biological|HyperAcute-Pancreas Immunotherapy|Up to 18 immunizations of 300 million immunotherapy cells
16241566|NCT01072981|Drug|Gemcitabine|Gemcitabine 1000 mg/m2/day once a week for 3 weeks
16241567|NCT01072981|Radiation|5FU Chemoradiation|5FU 200-250 mg/m2/day over 5 1/2 weeks with radiation.
16241568|NCT01072968|Drug|BF2.649|1 capsule per day in the morning before the breakfast
16241569|NCT01072968|Drug|Placebo|1 capsule per day in the morning before the breakfast
16241570|NCT01072955|Biological|Bovine Heparin|5.000UI/mL bottle with 5mL
16241571|NCT01072955|Biological|Porcine heparin|5000 USP Heparin Units / mL vial with 10 mL vial
16241572|NCT01072942|Drug|Ciprofloxacin (Cipro InhaIe, BAYQ3939)|Ciprofloxacin Inhale 50 and 75 mg 2 times a day (BID) for 10 days
16241573|NCT01072942|Drug|Placebo|Placebo TID for 10 days
16241574|NCT01072929|Drug|Armodafinil|Doses of either 150mg/day or 200 mg/day in tablet form taken orally, once daily in the morning.
16241575|NCT01072929|Drug|Placebo|Matching Placebo, also in tablet form taken orally, once daily in the morning.
16241576|NCT01072890|Drug|Temsirolimus, Pazopanib|Patients will be treated on an outpatient basis with both temsirolimus and pazopanib. All patients will receive temsirolimus intravenously (IV) weekly days 1, 8, 15, and 22. Patients will receive oral pazopanib on a daily basis starting day 1. Treatment will be administered on 28 day cycles. Patients will be in this study for a minimum of 8 weeks or 2 cycles.
16241577|NCT01072877|Drug|Polidocanol injectable foam (PEM)|Injection of Polidocanol injectable foam
16241578|NCT01072877|Drug|Placebo Vehicle|Placebo vehicle
16241579|NCT01072864|Other|Walnuts|Consumption of 5 g of walnuts.
16241580|NCT01072864|Other|Walnuts|Consumption of 20 g of walnuts.
16241581|NCT01072864|Other|Walnuts|Consumption of 30 g of walnuts.
16241582|NCT01072864|Other|Walnuts|Consumption of 40 g of walnuts.
16241583|NCT01072851|Behavioral|Multimedia Education|A four minute exposure to an educational video with controlled content on the importance of colorectal cancer screening and explaining the processes and procedures.
16241584|NCT01072851|Behavioral|Print Media|Exposure to a printed brochure with controlled content on the importance of colorectal cancer screening and explaining the processes and procedures.
16241585|NCT01072851|Behavioral|Usual and customary waiting room process|No specialized educational intervention to promote colorectal cancer screening or to explain the process
16241586|NCT01072838|Radiation|APBI (Dose Escalation)|"Accelerated, hypofractionated partial breast radiotherapy.
~3 dose schemes followed for 6 months each."
16241587|NCT01072838|Device|Contura MLB Breast Brachytherapy Catheter|
16241588|NCT01072825|Other|questionnaires|a descriptive questionnaire, SF-36, , bone questionnaires, Baecke physical activity questionnaire, voice evaluation
16241667|NCT01072279|Other|Tubaramure (Burundi)|Different combinations of family food rations, individual food rations, micronutrient supplements and behavior change communication to encourage optimal and age-appropriate infant and child feeding practices
16241589|NCT01072825|Biological|blood sampling|LFT (AST, ALT), CRP, creatinine, glucose, Total Cholesterol, Triglycerides, HDL-CH, LDL-CH, 25OH vitamin D, PSA if> 45 years, Hematocrit, testosterone, sex hormone-binding globulin, free testosterone , oestradiol, prolactin, luteinizing hormone, TSH, androgeengevoeligheids test (CAG RL), oral glucose tolerance test
16241590|NCT01072825|Other|clinical evaluation|height, weight, blood pressure, chestcircumference, waist circumference, grip strength, measuring 2 ° and 4 ° finger, and Ferriman Gallwey score
16241591|NCT01072825|Other|Dermatology evaluation|Evaluation of the hair pattern, using the Leeds acne classification scale, acne scars through ECCA scale (échelle d'évaluation clinique des cicatrices d'acné), androgenetic alopecia, and sebummetrie
16241592|NCT01072825|Other|Bone evaluation|PQCT scanner, BMD assessment
16241593|NCT01072812|Drug|Posiphen® tartrate capsules|Capsules administered (240 mg/day) for 10 days Capsules administered (160 mg/day) for 10 days
16241594|NCT01072799|Biological|Placebo|Two doses (Day 1 and Day 22); 0.5mL
16241595|NCT01072799|Biological|A/H1N1 2009 Influenza VLP Vaccine|Two doses (Day 1 & Day 22); 0.5mL
16241596|NCT01072786|Biological|TetraVax-DV Vaccine-Admixture 1|One subcutaneous injection of a recombinant live attenuated TetraVax-DV vaccine, admixture 1 (10^3 PFU of rDEN1Δ30, 10^3 PFU of rDEN2/4Δ30[ME], 10^3 PFU of rDEN3-3´D4Δ30, 10^3 PFU of rDEN4Δ30)
16241597|NCT01072786|Biological|TetraVax-DV Vaccine-Admixture 2|One subcutaneous injection of a recombinant live attenuated TetraVax-DV vaccine, admixture 2 (10^3 PFU of rDEN1Δ30, 10^3 PFU of rDEN2/4Δ30[ME], 10^3 PFU of rDEN3-3´D4Δ30, 10^3 PFU of rDEN4Δ30-200,201)
16241598|NCT01072786|Biological|TetraVax-DV Vaccine-Admixture 3|One subcutaneous injection of a recombinant live attenuated TetraVax-DV vaccine, admixture 3 (10^3 PFU of rDEN1Δ30, 10^3 PFU of rDEN2/4Δ30[ME], 10^3 PFU of rDEN3Δ30/31-7164, 10^3 PFU of rDEN4Δ30)
16241599|NCT01072786|Biological|TetraVax-DV Vaccine-Admixture 4|One subcutaneous injection of a recombinant live attenuated TetraVax-DV vaccine, admixture 4 (10^3 PFU of rDEN1Δ30, 10^3 PFU of rDEN2/4Δ30[ME], 10^3 PFU of rDEN3Δ30/31-7164, 10^3 PFU of rDEN4Δ30-200,201)
16241600|NCT01072786|Biological|Placebo|One subcutaneous injection of a placebo containing vaccine diluent but no actual vaccine
16241601|NCT01072786|Biological|TetraVax-DV Vaccine-Admixture 5|One subcutaneous injection of a recombinant live attenuated TetraVax-DV vaccine, admixture 5 (10^3 PFU of rDEN1Δ30, 10^4 PFU of rDEN2/4Δ30(ME), 10^3 PFU of rDEN3Δ30/31-7164, and 10^3 PFU of rDEN4Δ30)
16241602|NCT01072773|Drug|bortezomib|1.3 mg/m^2, by IV on days 1, 8 and 15 every 28 days
16241603|NCT01072773|Drug|cyclophosphamide|300 mg/m^2, orally, on days 1, 8, 15 & 22 every 28 days.
16241604|NCT01072773|Drug|dexamethasone|40 mg, orally, on days 1, 8, 15 & 22 every 28 days
16241605|NCT01072760|Procedure|K wire|Mallet finger treatment
16241606|NCT01072747|Biological|bovine heparin|5.000UI/mL bottle with 5mL
16241607|NCT01072747|Biological|Porcine heparin|5000 USP Heparin Units / mL vial with 10 mL vial
16241608|NCT01072734|Drug|Vaccine|Influenza vaccine
16241609|NCT01072721|Other|Elastometry|Fibrosis detection with FIBROSCANN
16241610|NCT01072708|Other|Prospective cohort with an annual follow-up|"Annualfollow-up including :
~oral glucose tolerance test
~dietary survey
~biological evaluation
~bacteriological and respiratory measures
~dual-energy x-ray absorptiometry
~physical activity survey"
16241611|NCT01072695|Drug|GS-9256|75 mg BID x 28 days
16241612|NCT01072695|Drug|GS-9190|40 mg BID x 28 days
16241613|NCT01072695|Drug|Ribavirin|1000-1200 mg/day given BID
16241614|NCT01072695|Drug|Peginterferon alfa-2a|180 ug q week
16241615|NCT01072682|Device|Selective cytopheretic device (SCD)|The selective cytopheretic device (SCD) is comprised of tubing, connectors and a hemofilter cartridge. The device is connected in series to a commercially available Continuous Renal Replacement Therapy (CRRT) device. Blood from the CRRT circuit is diverted after the CRRT hemofilter through to the extra capillary space (ECS) of the SCD. Blood circulates through this space and is returned to the patient via the venous return line of the CRRT circuit. Regional citrate anticoagulation is used for the entire CRRT and SCD blood circuits.
16241616|NCT01072669|Drug|ambrisentan|Subjects will receive ambrisentan 5 mg orally once daily or identical placebo pills for the first 4 weeks and then increased to ambrisentan 10mg once daily[if the lower dose is tolerated] or identical placebo pills for the rest of the study. They will be instructed to take the 5mg/pink pills for 4 weeks and then switch to 10mg /red pills unless they are having any drug related side effects or concerns. There will be no routine visit planned at 4 weeks to assess drug tolerance unless a complication arises. Adherence to treatment will be assessed by pill counting at each follow up visit. Follow up digital blood flow measurements will be obtained with LDPI at 1 week and at 3 months, where the same protocol (as that in the initial visit) will be followed.
16241617|NCT01072656|Device|Deep Brain Stimulation for Thalamic Pain Syndrome|Patients will be randomized in a 1:1 ratio to one of two groups: the Treatment Group (active stimulation and programmed to the settings found to be optimal during the titration phase) and the Control Group (sham stimulation - IPG is set to ON but the voltage is set to 0V). In order to prevent too many patients from being randomized to ON or to sham early in the study, we will use, for the first 4 patients, randomization blocks of four or six. In this fashion, the first four consecutive patients will have two patients randomized to the Treatment Group and two patients in the Control Group. In the same fashion, the final six patients will have three patients randomized to the treatment group and three patients to the control group.
16241618|NCT01072643|Drug|Dexmedetomidine|This is a single center, dose escalation study of Dexmedetomidine in pediatric subjects with pulmonary hypertension (PVR>4WU) undergoing hemodynamic cardiac catheterization and vasoreactivity drug testing. Cohorts of 8 evaluable subjects will receive dose level 1, dose level 2, or dose level 3 of Dexmedetomidine.
16241619|NCT01072630|Drug|Armodafinil|Doses of either 150mg/day or 200 mg/day in tablet form taken orally, once daily in the morning.
16241620|NCT01072630|Drug|Placebo|Matching Placebo, also in tablet form taken orally, once daily in the morning.
16241668|NCT01072279|Other|Procomida (Guatemala)|Different combinations of family food rations, individual food rations, micronutrient supplements and behavior change communication to encourage optimal and age-appropriate infant and child feeding practices
16241669|NCT01072266|Drug|INCB028060|10 mg and 50 mg capsules will be provided and dosed per the dosing schedule.
16241670|NCT01072253|Procedure|eye amputation|
16241671|NCT01072240|Drug|rituximab [Mabthera/Rituxan]|As prescribed by physician
16241621|NCT01072617|Device|Transcranial magnetic stimulation via MagPro x100 device|"Participants will receive 10 repetitive transcranial magnetic stimulation sessions to the vermis of cerebellum using the MagPro x100 TMS device. These 10 rTMS sessions will be administered from Monday to Friday in five days, twice a day with a minimum of 4-hour gap between the sessions. Repetitive TMS will be applied with the intermittent theta burst pattern (iTBS). These parameters are known to cause excitation in brain activity.
~Anatomically precise localization of rTMS will be achieved using a frameless stereotactic system."
16241622|NCT01072604|Drug|Acetylsalicylic acid (Aspirin, BAY1019036)|One oral dose of new formula Aspirin Prototype 1 under fasting conditions
16241623|NCT01072604|Drug|Acetylsalicylic acid (Aspirin, BAY1019036)|One oral dose of new formula Aspirin Prototype 2 under fasting conditions
16241624|NCT01072604|Drug|Acetylsalicylic acid (Aspirin, BAYE4465)|One oral dose of Aspirin Plain Tablet under fasting conditions
16241625|NCT01072604|Drug|Acetylsalicylic acid (Aspirin, BAYE4465)|One oral dose of Aspirin Dry Granules under fasting conditions
16241626|NCT01072591|Drug|MEDI-578|intravenous infusion, once
16241627|NCT01072591|Drug|Placebo for MEDI-578|Intravenous infusion, once
16241628|NCT01072578|Drug|Dapagliflozin|Dapagliflozin tablets 5 mg, Oral Twice daily dose for 5 days (total daily dose 10 mg)
16241629|NCT01072578|Drug|Dapagliflozin|Dapagliflozin tablets, 10 mg, Oral, once daily dose for 5 days
16241630|NCT01072565|Other|SMBG to guide clinical decisions|The investigator will base clinical decisions on A1c and modal day analysis of SMBG.
16241631|NCT01072565|Other|SMBG and CGM|The investigator will base clinical decisions on A1c, modal day analysis of SMBG and CGM data.
16241632|NCT01072539|Drug|tigecycline|As prescribed by physician in usual clinical practice
16241633|NCT01072526|Drug|Euphrasia-based homeopathic therapy|ophthalmic solution; 1 drop both eyes twice daily
16241634|NCT01072526|Drug|Cyclosporin solution|Cyclosporin solution; 1 drop both eyes twice daily
16241635|NCT01072513|Other|Semen analysis|Semen analysis before and after proton radiation therapy.
16241636|NCT01072500|Behavioral|Physical Activity|The physical activity intervention consists primarily of walking at moderate intensity, lower extremity resistance exercises, balance exercises, stretching and behavioral counseling.
16241637|NCT01072500|Behavioral|Successful Aging|The successful aging intervention consists of health education seminars regarding health-related matters and upper extremity stretching exercises.
16241638|NCT01072487|Procedure|Capnography|Monitoring of the capnography curve for early detection of apnea
16241639|NCT01072474|Procedure|Capnography|Capnographic monitoring
16241640|NCT01072474|Procedure|Standard monitoring|Standard monitoring
16241641|NCT01072461|Behavioral|HAS Training|Robotically measured and facilitated training of the hemiparetic hand and arm in isolation, in a three dimensional haptically rendered virtual environment.
16241642|NCT01072461|Behavioral|HAT training|Robotically measured and facilitated training of the hemiparetic hand and arm as an integrated functional unit, in a three dimensional haptically rendered virtual environment
16241643|NCT01072461|Behavioral|Bimanual Training|Robotically measured and facilitated training of the hemiparetic hand and non-hemiparetic hand together, in a three dimensional haptically rendered virtual environment
16241644|NCT01072448|Drug|Indacaterol 75 μg|Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
16241645|NCT01072448|Drug|Placebo to indacaterol|Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
16241646|NCT01072435|Device|Patient-controlled sedation|Administration of short-acting anesthetic propofol via self-administration device.Single bolus-dose 1ml(10mg)of propofol,lockout time 0sec.,no background infusion or dose-limit.
16241647|NCT01072435|Device|Target-controlled infusion|Anaesthesiologist´s managed target-controlled infusion of short-acting anesthetic propofol
16241648|NCT01072422|Behavioral|smoking cessation|Use of trying to quit smoking instrument and quit smoking advice
16241649|NCT01072409|Device|Nucleus 5 Cochlear implant|Cochlear implant surgery
16241650|NCT01072409|Device|Cochlear implantation|Implantation
16241651|NCT01072396|Drug|Tiotropium|double blind randomized crossover
16241652|NCT01072396|Drug|Placebo|inhalation powder capsule identical to those containing tiotropium bromide inhalation powder
16241653|NCT01072383|Drug|BT061|administration of BT061 either intravenous or subcutaneous
16241654|NCT01072383|Drug|placebo treatment|administration of the end formulation buffer of BT061 without active ingredient, either subcutaneous or intravenous
16241655|NCT01072370|Biological|Cord Blood Infusion|red-cell depleted, mononuclear cell enriched cord blood unit prepared for infusion
16241656|NCT01072370|Biological|Intravenous Sham|intravenous infusion of 5% dextrose, ¼ normal saline solution
16241657|NCT01072357|Drug|Avastin® (bevacizumab)|One time subconjunctival injection of 0.1 mL (2.5 mg) bevacizumab followed by topical treatment with 1% solution bevacizumab four times a day for four weeks.
16241658|NCT01072357|Drug|0.9% NaCl & Refresh Liquigel|One-time subconjunctival injection of 0.1mL 0.9% NaCl followed by topical treatment with Refresh Liquigel four times a day for four weeks
16241659|NCT01072344|Drug|Chamomile (Matricaria recutita)|500 mg 3 times daily
16241660|NCT01072331|Drug|MP-513|MP-513 10 mg, once a day, for 4 weeks
16241661|NCT01072331|Drug|MP-513|MP-513 20 mg, once a day, for 4 weeks
16241662|NCT01072331|Drug|Placebo of MP-513|MP-513 placebo, once a day, for 4 weeks
16241663|NCT01072318|Drug|Letrozole|Letrozole 2.5mg
16241664|NCT01072305|Device|Intermittent pneumatic compression (IPC)|Intermittent pneumatic compression (sequential compression) using a cuff consisting of 12 chambers inflated sequentially from forefoot to groin with decremental inflation pressures (60-38 mmHg), pressure release after complete inflation, and reinflation after 4 seconds pause. ICP cuffs are covered with a frame and drapes for blinding purpose.
16241665|NCT01072305|Device|IPC - placebo|ICP cuffs are placed next to/between legs and covered with a frame and drapes for blinding purpose. IPC device is run fom induction of general anesthesia to closure of the skin.
16241666|NCT01072292|Behavioral|CBT-I|CBT-I is a six week program designed to improve sleep quality in people with COPD.
16241672|NCT01072227|Procedure|Sample Collection|Tissue
16241681|NCT01072175|Drug|GSK2118436|GSK2118436 is a potent and selective inhibitor of BRAF kinase activity with a mode of action consistent with adenosine triphosphate-competitive inhibition.
16241682|NCT01072175|Drug|GSK1120212|GSK1120212 is a potent and highly selective inhibitor of MEK1/2 activation and kinase activity.
16241683|NCT01072162|Drug|Eltrombopag|25 mg tablet
16241684|NCT01072162|Drug|Eltrombopag|25 mg powder for oral suspension
16241685|NCT01072149|Drug|Fluticasone Furoate (FF)/GW642444 Inhalation Powder|Inhaled Corticosteroid (ICS)/ Long Acting Beta Agonist(LABA) for COPD
16241686|NCT01072149|Device|placebo|placebo
16241687|NCT01072136|Other|Placebo|Capsule will be filled with lactose and be identical in appearance to the capsule with the active ingredient.
16241688|NCT01072136|Drug|Azithromycin|Single dose will consist of 2 over-encapsulated capsules (500 mg each) administered orally.
16241689|NCT01072136|Drug|Cefixime|Single dose will consist of 1 over-encapsulated capsule (400 mg) administered orally.
16241690|NCT01072123|Other|Quest for the Code|interactive asthma-based computer program
16241691|NCT01072110|Procedure|Colonoscopy|Patients will undergo colonoscopy for evaluation of their symptoms.
16241692|NCT01072110|Procedure|Confocal Laser Endomicroscopy|Patients will undergo CLE during their endoscopy. Findings will be compared to group 1.
16241693|NCT01072097|Drug|Atorvastatin|Atorvastatin 20mg/day for 6 months
16241694|NCT01072097|Drug|Placebo|Placebo for 6 months
16241695|NCT01072071|Drug|furosemide|"Loading dose: 0,5mg/kg Start continuous infusion at a dose of 0,1mg/kg/h and titrate according to diuretic response.
~Target value for diuresis = (amount of fluids administered at inclusion/kg/h) + 0.5mL/kg/h If safety check is satisfactory: increase target diuresis with 1mL/kg/h per 4h to a maximum of (amount of fluids administered at inclusion/kg/h) + 2.5mL/kg/h Maximal dose of furosemide: 0.3mg/kg/h Safety check every 4h. Furosemide is administered for 24h. If safety checks are satisfactory, additional periods of 24 can be added up to a maximum of 72h."
16241696|NCT01072058|Drug|TNF blockers (infliximab, adalimumab, etanercept)|Subjects enrolled, who were eligible to anti-TNF therapy, were evaluated by echocardiography (conventional and tissue doppler imaging)and biomarkers (NT-proBNP and troponin T)at baseline. Then, they were treated with adalimumab 40mg subcutaneously every 2 weeks or infliximab 3 or 5mg/Kg (0, 2 and 6 weeks and thereafter every 8 weeks)or etanercept 50mg subcutaneously every week. And they were re-evaluated with 6, 12, 18 and 24 months from first dose of the TNF blocker .
16241697|NCT01072045|Drug|Propranolol|Oral propranolol, at a dose of 2mg/kg/day, divided in 2 doses, for initial 60 days
16241698|NCT01072045|Drug|Prednisone|Oral prednisone, at a dose of 2mg/kg/day, divided in 2 doses, for initial 60 days
16241699|NCT01072032|Device|Anklebot (Ankle Robot)|Impedance controlled ankle robot provides assistance as needed for participants to perform ankle movements while playing a video game, is used to assist stroke patients to enhance motor recovery
16241700|NCT01072019|Other|Instrument|Randomization to instrumentation to be used for primary total knee replacement; either standard knee cutting guides or MRI generated patient specific custom cutting guides.
16241701|NCT01071993|Drug|placebo|pre-treatment with placebo (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
16241702|NCT01071993|Drug|atorvastatin|pre-treatment with atorvastatin (80 mg 12 hours prior to the procedure and 40 mg pre-procedure)
16241703|NCT01071980|Other|Work Place Adjusted Intelligent Physical Exercise Reducing Musculoskeletal Pain in Shoulder and Neck|Participants will be randomized at the cluster level to a control group or 20 weeks of specific resistance training for 3 x 20 min a week
16241704|NCT01071967|Other|Community-based nurse care management|The community-based nurse care management program developed by Health Quality Partners uses nurses working in the community to provide the following integrated set of services to older adults with chronic illness over the long term in order to prevent avoidable complications of their diseases and aging; geriatric assessment, care coordination, health education, self-management coaching, weight management, physical activity, gait and balance training, medication adherence, care transition support, ongoing monitoring and symptom detection, collaborative problem solving with patients, families and health care providers.
16241705|NCT01071954|Biological|Romiplostim|Administered by subcutaneous injection once a week.
16241706|NCT01071941|Biological|administration of rRp450 into the hepatic artery|Administration of rRp450 into the hepatic artery either as a single infusion, or as four infusions administered every one to two weeks.
16241707|NCT01071928|Drug|Docetaxel|Docetaxel IV 75 mg/m2 over approximately 60 minutes on Day 1
16241708|NCT01071928|Drug|ASA404|ASA404 (given after Docetaxel)IV 1800 mg/m2 over approximately 20 minutes on Day 1
16241709|NCT01071915|Drug|Degarelix 240/80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent maintenance doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections at 28 day intervals from day 28 to day 168.
16241710|NCT01071902|Drug|Moxidex otic solution|4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
16241711|NCT01071902|Drug|Moxifloxacin otic solution|4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
16241712|NCT01071902|Other|Vehicle|4 drops into the infected ear(s) twice daily (morning and evening) for 7 days
16241713|NCT01071902|Device|Tympanostomy tubes|Tubes surgically inserted through the ear drum for the treatment of recurrent otitis media in children
16241714|NCT01071889|Drug|Flumazenil|Flumazenil- 0.4 mg per 100 µl in a sublingual spray administration
16241715|NCT01071889|Drug|Placebo|Placebo - only excipients with no API
16241716|NCT01071876|Drug|BF2.649|1 capsule in the morning before breakfast
16241717|NCT01071876|Drug|Placebo|1 capsule in the morning before breakfast
16241718|NCT01071850|Drug|ipragliflozin|oral tablet
16241719|NCT01071850|Drug|Metformin|oral tablet
16241720|NCT01071850|Drug|Placebo|oral tablet
16241721|NCT01071837|Drug|APG101|400mg weekly as intravenous infusion
16241722|NCT01071837|Procedure|Blood drawing|Blood drawings, e.g. for safety labs, abdominal ultrasound, ECG. Re-Irradiation is not considered a study procedure, but standard of care (inclusion criterion)
16241723|NCT01071824|Procedure|Transverse coloplasty pouch (Long limb)|Transverse coloplasty pouch with long limb
16242040|NCT01069237|Device|Clear Care|Lens Care Solution for contact lenses
16241724|NCT01071824|Procedure|Transverse coloplasty pouch (Short limb)|Transverse coloplasty pouch with short limb
16241725|NCT01071811|Behavioral|Pedometer-based intervention|The participants were randomly assigned to either a pedometer group or a control group by drawing a sealed envelope with a unique randomizing number. The participants in the pedometer group received a pedometer (Yamax Digi-Walker SW-200), a book with a pedometer program(18), a handout with a summary of the pedometer program, and a calendar for registration of daily steps. During the trial period they were asked to reset the pedometer every morning and to wear it during the entire day. In the evening they should take the pedometer off and register the accumulated steps in the calendar. After three, six, and nine weeks, the participants in the pedometer group got a mail to encourage them to keep using the pedometer and follow the program.
16241726|NCT01071798|Drug|Rituximab|As prescribed by physician
16241727|NCT01071785|Dietary Supplement|guar gum|guar gum 10g/day for six weeks
16241728|NCT01071772|Drug|insulin|There will be used individual intravenous insulin (actrapid) infusion to prevent non-intended hyperglycemia.
16241729|NCT01071720|Drug|CKD-501 1mg|This study is randomized, balanced, single-dose, two treatment (fed versus fasting), two-period, two sequence crossover design to assess the effects of food on pharmacokinetics profile.
16241730|NCT01071694|Drug|Interferon beta 1-b (Betaferon/Betaseron, BAY86-5046)|Patients receiving Betaferon according to routine clinical practice
16241731|NCT01071681|Drug|Telmisartan (Kinzal/Pritor, BAY68-9291)|Patients under daily life treatment receiving Pritor according to local drug information.
16241732|NCT01071655|Drug|BVZ+XELOX or BVZ+XELIRI or BVZ+FUIRI or BVZ+FUOX|"BVZ + XELOX. Bevacizumab 7,5 mg/kg day 1; capecitabine 1000 mg/m2/12 h days 1-14; oxaliplatin 130 mg/m2 day 1
~BVZ + XELIRI. Bevacizumab 7,5 mg/kg day 1; Capecitabine 800 mg/m2/12 h days 1-14; Irinotecan 200 mg/m2 day 1
~BVZ + FUIRI. Bevacizumab 5 mg/kg biweekly; 5-FU 2.250 mg/m2 weekly; Irinotecan 80 mg/m2 weekly
~BVZ + FUOX. Bevacizumab 5 mg/kg biweekly; 5-FU 2.250 mg/m2 weekly; Oxaliplatin 85 mg/m2 biweekly"
16241733|NCT01071655|Drug|BVZ+XELOX|BVZ + XELOX. Bevacizumab 7,5 mg/kg day 1; capecitabine 1000 mg/m2/12 h days 1-14; oxaliplatin 130 mg/m2 day 1
16241734|NCT01071642|Drug|stop ace-i/arb 24 h before procedure and restarted 24 hours after the procedure|ACE/ARB stopped 24 hours prior to the procedure and restarted 24 hours after the procedure
16241735|NCT01071642|Drug|ACE/ARB stopped 24 hours before procedure and start immediately after|ACE/ARB stopped 24 hours prior to the procedure and restarted immediately after the procedure
16241736|NCT01071629|Other|Exercise training|Interval training (30 sec 50% of peak Work Rate achieved at the steep ramp test/60 sec recovery no exercise) for 40 min in the interval training group
16241737|NCT01071629|Other|Exercise training|Interval training (30 sec 50% of peak Work Rate achieved at the steep ramp test/60 sec recovery no exercise) for 20 min and Strength training of the quadriceps, hamstrings, muscles of the shoulder and biceps brachialis for 20 min 3 times per week for 36 sessions
16241738|NCT01071616|Drug|Cannabis Cigarette|
16241739|NCT01071564|Drug|Gamma-Secretase Inhibitor RO4929097|Given PO
16241740|NCT01071564|Other|Laboratory Biomarker Analysis|Correlative studies
16241741|NCT01071564|Other|Pharmacogenomic Study|Correlative studies
16241742|NCT01071564|Other|Pharmacological Study|Correlative studies
16241743|NCT01071564|Drug|Vismodegib|Given PO
16241744|NCT01071551|Behavioral|Life-style intervention|"The Nutrition Enrichment and Healthy Living Model (NEHLM) is an Integrative model covering variety of lifestyle issues such as nutrition, dental care, and physical activity. The model will be applied to kindergartens and a sample of their parents. Children participating will be given 10 lessons in nutrition, 5 lessons in dental-care and 20 physical activity lessons. Parents for children in this group will be given 2 nutrition-education meetings and a meeting with a dental clinician.2 additional meetings will be held for parents and children together, one in nutrition and one in dental-care."
16241745|NCT01071551|Behavioral|Physical activity only|Children allocated to this group will attend 20 physical activity classes.
16241746|NCT01071538|Drug|Buprenorphine|Sublingual buprenorphine 0.2 mg will be used for the first week. The dose will be increased by 0.2 mg/week based on safety and clinical response up to a maximal dose of 1.6 mg/day.
16241747|NCT01071525|Drug|Niacin\Laropiprant|Hypercholesterolemic patients with low HDL will receive Niacin\Laropiprant
16241748|NCT01071512|Drug|Tysabri|Infuse TYSABRI® 300 mg in 100 mL 0.9% Sodium Chloride Injection, USP over approximately one hour. After the infusion is complete, flush with 0.9% Sodium Chloride Injection, USP. Tysabri will be infused every four weeks.
16241749|NCT01071499|Drug|Morphine|One dose of morphine (0.1 mg/kg)
16241750|NCT01071499|Drug|Morphine|One dose of morphine (0.2 mg/kg)
16241751|NCT01071499|Drug|Morphine|One dose of morphine (0.3 mg/kg)
16241752|NCT01071486|Drug|Hematological Stem Cell Transplantation|Oral or Intravenous Busulfan as part of the preparative protocol for transplantation
16241753|NCT01071473|Other|12 Week Exercise Intervention|Trial of a 12-week period of combined endurance and resistance training in survivors of childhood cancer who were treated with doxorubicin and/or daunorubicin and have impaired cardiac function.
16241754|NCT01071460|Device|FlexStent Femoropopliteal Self-Expanding Stent System|"Peri-procedural management will be no different to routine SFA/Popliteal Artery intervention Standard medical therapy
~Procedural techniques will be identical to routine protocols for SFA/Popliteal Artery stenting. technique suggested:
~Contralateral retrograde common femoral cross-over access or antegrade access
~Target lower limb arteries fully imaged angiogram. with measurement of SFA/Popliteal Artery target lesion length and normal vessel diameter immediately above and below target lesion
~Pre-stenting balloon dilatation of target lesion in all total occlusions and critical stenosis
~Deployment of an appropriately sized FlexStent® to cover target lesion
~Post-stent balloon dilate stent using a semi-compliant angioplasty balloon to enable accurate post-dilatation of stent to target diameter
~Post stenting angiography assessing target lesion parameters, run-off vessel patency and complications"
16241755|NCT01071447|Other|Nurse-led clinic vs rheumatologist-led clinic|The subjects are seeing a rheumatology nurse (experimental arm)instead of a rheumatologist (active comparator arm) after six months. Subjects in both arms are seeing a rheumatologist after 12 months and have the possibility to contact the rheumatology nurse.
16241756|NCT01071434|Procedure|MR Imaging|
16241867|NCT01070602|Procedure|anterior (more central) corneal paracentesis incision|3 corneal paracentesis incisions will be located 1 mm anterior to the limbus.
16241757|NCT01071421|Device|abbreviated polysomnography|Both groups will be studied with in-hospital respiratory polygraphy during the sleep. The group A will be studied with another respiratory polygraphy in the home one month after the resolution of CAP. Some questionnaires to measure the sleepiness (Epworth test), FOSQ test, in-home sleepiness questionnaire and symptoms questionary will be obtained in Group A and B
16241758|NCT01071408|Other|Stroke prevention care program|Stroke prevention care program consists of group clinics, telephone coordination of care, and tracking of care through registries in the first 7 months after stroke or TIA presentation. A nurse practitioner will follow algorithms to adjust medications and to motivate patients to improve lifestyle habits.
16241759|NCT01071395|Drug|Amantadine|Amantadine hydrochloride 300mg daily in three divided doses
16241760|NCT01071395|Drug|Placebo|Sugar pill given 3 times daily
16241761|NCT01071369|Drug|Xylocaine|0.5% Xylocaine
16241762|NCT01071369|Drug|Xylocaine and Celestone|non-particulate Celestone
16241763|NCT01071356|Behavioral|Intensive MI|Weekly individual therapy sessions over 9 weeks (Intensive MI condition) consisting of supportive and directive interventions. The control condition consists on a single session of MI and nutritional education.
16241764|NCT01071356|Behavioral|Single session MI|Comparator arm that includes 1.5 hours of MI, 8 hours of nutrition classes and outpatient substance abuse treatment
16241765|NCT01071343|Device|Transcutaneous electrical muscle stimulation|After randomization of the quadriceps muscles TEMS is applied on the intervention side for 7 consecutive days, 60 minutes per day.
16241766|NCT01071317|Drug|Naproxen|Naproxen 500mg PO bid prn headache
16241767|NCT01071317|Drug|Sumatriptan|100mg po q day prn headache
16241768|NCT01071317|Behavioral|Migraine education|Educational program available through NIH/ national library of medicine/ X-plain
16241769|NCT01071317|Behavioral|Reenforcement of diagnosis|Patient advised has migraine headache and how the headache meets migraine criteria
16241770|NCT01071317|Other|Typical care|Care to be determined by attending physician
16241771|NCT01071304|Drug|Midazolam|A single oral dose of midazolam 2 mg (1 mL of 2 mg/mL syrup) was given on Day -2 and Day 5.
16241772|NCT01071304|Drug|Ridaforolimus|Ridaforolimus 40 mg (4 x 10 mg tablets) oral once daily on Days 1 through 5.
16241773|NCT01071291|Drug|Niaspan|Niaspan™
16241774|NCT01071291|Drug|Comparator: Placebo|Placebo
16241775|NCT01071265|Procedure|Remote Ischemic Preconditioning|Occlusion of leg blood flow using a pneumatic tourniquet on the thigh. Tourniquets are inflated to 300 mmHg for 5 minutes followed by deflation for 5 minutes then repeated for a total of 3 inflations.
16241776|NCT01071265|Procedure|Sham|Sham procedure. A pneumatic tourniquet is placed on an upper arm and/or thigh but not inflated.
16241777|NCT01071252|Drug|AIN457|
16241778|NCT01071252|Drug|Placebo|
16241779|NCT01071239|Device|CliniMACs device|Donor Peripheral blood progenitor cells will use CD34+ selection with the use of the CliniMACs device
16241780|NCT01071239|Drug|Busulfan|Chemotherapy administered as a part of the HSCT conditioning regimen.
16241781|NCT01071239|Drug|Fludarabine|Chemotherapy administered as a part of the HSCT conditioning regimen.
16241782|NCT01071239|Drug|Cyclophosphamide|Chemotherapy administered as a part of the HSCT conditioning regimen.
16241783|NCT01071239|Drug|ATG|Chemotherapy administered as a part of the HSCT conditioning regimen.
16241787|NCT01071200|Drug|Recombinant human Follicle Stimulating Hormone (r-hFSH) and Recombinant human Luteinizing Hormone (r-hLH)|One r-hFSH and one r-hLH injection subcutaneously (s.c.) once daily during the treatment phase from Day 8 of stimulation until injection of human chorionic gonadotropin (hCG) or cancellation of the treatment cycle.
16241788|NCT01071200|Drug|r-hFSH|One r-hFSH injection s.c. once daily during the treatment phase from Day 8 of stimulation until injection of hCG or cancellation of the treatment cycle.
16241789|NCT01071187|Drug|Varenicline|Varenicline 0,5mg daily on day 1-3, Varenicline 1mg daily on day 4-7 and Varenicline 2mg on day 8-84.
16241790|NCT01071187|Drug|Placebo|Placebo
16241791|NCT01071174|Other|Dapivirine|Vaginal ring containing 25mg dapivirine; One ring inserted every 28 days for 84 days (3 rings total)
16241792|NCT01071174|Other|Placebo|Vaginal Ring containing no drug substance
16241793|NCT01071161|Drug|azithromycin|azithromycin, tablets, during 12 weeks, three times a week, 250mg
16241794|NCT01071161|Drug|placebo|placebo
16241795|NCT01071135|Drug|Quetiapine XR|Quetiapine XR (Seroquel Prolong®) extended-release tablets à 50 mg und 200 mg. Seroquel Prolong® should be administered as the only neuroleptics preferably once daily, preferably in the evening. The recommended initial dose is 200 mg/day. Patients should be titrated within a dose range of 400 - 800 mg/day depending on the response and tolerance of the individual patient. Dose increases can be made at intervals as short as 1 day and in increments of up to 200 mg/day. Seroquel Prolong® tablets should be swallowed whole and not split, chewed or crushed.
16241796|NCT01071122|Drug|Nifedipine (Adalat, BAYA1040) and Valsartan|Combination treatment with nifedipine GITS 30mg and valsartan 80mg, Once daily
16241797|NCT01071122|Drug|Nifedipine (Adalat, BAYA1040)|Nifedipine 60mg, Once daily
16241798|NCT01071122|Drug|Valsartan|Valsartan 160mg, Once daily
16241799|NCT01071109|Procedure|Therapeutic Massage|Therapeutic Massage--subjects randomized to this group will receive weekly, one-hour therapeutic massage
16241800|NCT01071096|Drug|OnabotulinumtoxinA|"Minimum dose of 155 U OnabotulinumtoxinA Purified Neurotoxin Complex administered at 31 fixed-site, fixed-dose injections across seven specific head/neck muscle areas. Subjects will continue to monitor headache symptoms with a headache diary and collect saliva samples as instructed.
~At investigator's discretion, additional 40 U OnabotulinumtoxinA Purified Neurotoxin Complex may be administered unilaterally or bilaterally, using follow-the-pain paradigm."
16241868|NCT01070576|Other|no intervention|no intervention
16241869|NCT01070563|Other|Transcranial doppler|A TCD is performed on all cerebral arteries (mean cerebral arteries, anterior cerebral arteries, basilar trunk, vertebral arteries and carotid arteries) until a flow pattern compatible with brain death is found
16241801|NCT01071096|Drug|Saline|"155 U Saline administered at 31 fixed-site, fixed-dose injections across seven specific head/neck muscle areas. Subjects will continue to monitor headache using a headache diary and collect saliva samples as instructed.
~At investigator's discretion, additional Saline may be administered unilaterally or bilaterally, using follow-the-pain paradigm."
16241802|NCT01071083|Drug|natalizumab|300 mg intravenous every 4 weeks
16241803|NCT01071083|Drug|interferon beta 1-a|30 ug intramuscular once per week
16241804|NCT01071083|Drug|methylprednisolone|1000 mg intravenous every 4 weeks
16241805|NCT01071083|Other|IV placebo|placebo intravenous every 4 weeks
16241806|NCT01071083|Drug|glatiramer acetate|20 mg subcutaneous once daily
16241807|NCT01071070|Drug|paricalcitol|Initiation dosing based on 2 approved package inserts , followed by a dose adjusted by limited chemistry test value. See Arm Description for additional details.
16241808|NCT01071057|Drug|Naloxone|Basal infusion of 20µg/kg/hour, bolus dose of 20µg /kg, lockout of 5 minutes with hourly maximum not to exceed 150µg /kg/hr, maximum 6 bolus doses. Subject pain relief will be assessed and documented by nursing staff and supervised by the Acute Pain Service (APS). Morphine will be titrated to subject need according to APS PCA protocol.
16241809|NCT01071057|Drug|Saline/Morphine|Basal infusion of 20µg/kg/hour, bolus dose of 20µg /kg, lockout of 5 minutes with hourly maximum not to exceed 150µg /kg/hr, maximum 6 bolus doses. Subject pain relief will be assessed and documented by nursing staff and supervised by the Acute Pain Service (APS). Morphine will be titrated to subject need according to APS PCA protocol.
16241810|NCT01071044|Drug|Lisdexamfetamine Dimesylate|Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the investigator.
16241811|NCT01071044|Drug|"Placebo 30, 50 or 70 mg"|Will be randomly assigned to one of two treatment arms in a 1:1 ratio of either LDX or placebo for 6 weeks. Subjects will be started with a single pill containing 30mg of LDX or comparable placebo, depending on the treatment assignment. At the week 2 visit, the dose will be increased to 50 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the Investigator. At the week 4 visit, the dose will be increased to 70 mg (or comparable placebo) if the patient exhibits no significant adverse effects as judged by the investigator.
16241812|NCT01071031|Biological|HIV-v (Low Dose)|"Low Dose HIV-v (a sterile lyophilised mixture of polypeptide T-cell epitope sequences) with water for injection or adjuvant
~Administration: A single subcutaneous injection"
16241813|NCT01071031|Biological|HIV-v (High Dose)|"High Dose HIV-v (a sterile lyophilised mixture of polypeptide T-cell epitope sequences with water for injection or adjuvant
~Administration: A single subcutaneous injection"
16241814|NCT01071031|Biological|HIV-v (Control)|"Adjuvant only or Water for injection only
~Administration: A single subcutaneous injection"
16241815|NCT01071018|Drug|MK2206 every other day|Dose escalation study: MK2206 will be administered as an oral formulation in rising dose levels of 45 mg and 60 mg, once daily every other day in repeating 4 week cycles.
16241816|NCT01071018|Drug|MK2206 once weekly|Dose escalation study: MK2206 will be administered as an oral formulation in rising dose levels of 135 mg and 200 mg, once weekly in repeating 4 week cycles.
16241817|NCT01071005|Drug|Lorelin Depot Bergamo|Lorelin Depot Bergamo, 3,75 mg, single dose.
16241818|NCT01071005|Drug|Lupron Depot - Abbott|Lupron Depot 3,75 mg, single dose.
16241819|NCT01070979|Drug|Estradiol acetate|Tablet containing 0.9 mg E3A, daily oral administration.
16241820|NCT01070979|Drug|Estradiol|Tablet containing 1 mg estradiol, daily oral administration.
16241821|NCT01070979|Drug|Conjugated equine estrogens|Tablet containing 0.625 mg CEE, daily oral administration.
16241822|NCT01070940|Drug|NG-monomethyl-L-arginine (L-NMMA)|3 mg/kg IV priming dose + 2 mg/kg/hr IV infusion for 1 hour
16241823|NCT01070940|Drug|NG-monomethyl-L-arginine (L-NMMA)|6 mg/kg IV priming dose + 4 mg/kg/hr IV infusion for 1 hour
16241824|NCT01070940|Drug|NG-monomethyl-L-arginine (L-NMMA)|4.5 mg/kg IV priming dose + 3 mg/kg/hr IV infusion for 1 hour
16241825|NCT01070940|Drug|Placebo|Isotonic saline solution IV priming dose + IV infusion for 1 hour
16241826|NCT01070927|Drug|RO4929097|80mg po daily, 3 days on 4 days off schedule
16241827|NCT01070927|Drug|RO4929097|recommended phaseII dose, orally once daily, 3 days on 4 days off schedule
16241828|NCT01070888|Drug|Budesonide/Formoterol|Budesonide/Formoterol 160/4.5, 2 puff twice daily for 2 weeks
16241829|NCT01070888|Drug|Budesonide|Budesonide 180mcg, 2 puffs twice daily for 2 weeks
16241830|NCT01070875|Drug|Variation of heparin dose|Study subjects will be randomized to receive unfractionated heparin 5000 U subcutaneous two times a day.
16241831|NCT01070875|Drug|Variation of heparin dose|Study subjects will be randomized to receive heparin 5000 U subcutaneous three times a day.
16241832|NCT01070862|Drug|Thalidomide, Dexamethasone|Thalidomide 200 mg/d for 3 months, Dexamethasone 40 mg/d D1-D4 and D14-D17 for 28d-3 cycles
16241833|NCT01070862|Drug|Vincristin , Adriamycin, Dexamethasone = VAD|Vincristin 0.4 mg/d continUous IV infusion D1-D4, Adriamycin 9 mg/m2 continuous IV infusion D1-D4, Dexamethasone 40 mg/d oral D1-D4 and D15-D18 for 2 first cycles, D1-D4 for the 3d cycle
16241834|NCT01070862|Drug|Thalidomide, melphalan, endoxan, dexamethasone (MCDex-Thal)|Thalidomide : 200 mg/d at bedtime for 3 months , melphalan: 6 mg/m2 oral D1-D4, endoxan 600 mg/m2 IV D1, dexamethasone 40 mg/d oral D1-D4 for 28-d 4 cycles
16241835|NCT01070862|Drug|melphalan, endoxan, dexamethasone (MCDex)|melphalan: 6 mg/m2 oral D1-D4, endoxan 600 mg/m2 IV D1, dexamethasone 40 mg/d oral D1-D4 for 28-d 4 cycles
16241836|NCT01070862|Drug|Thalidomide, Dexamethasone|Thalidomide 200 mg/d on every other 3 months Dexamethasone 40 mg/d D1-D4, D30-D34,D60-D64, D90-D94
16241870|NCT01070550|Drug|Peginterferon alfa-2a (Pegasys®)|Peginterferon (PEG-IFN) alfa-2a Peginterferon/ribavirin treatment period as prescribed by treating physician (e.g. 24 or 48 weeks) and treatment-free follow-up period of 24 weeks.
16241871|NCT01070537|Device|Bonfils fiberscope intubation|
16241872|NCT01070524|Drug|CHF 5188 pMDI|CHF 5188: fixed combination budesonide/carmoterol
16242128|NCT01068600|Drug|Placebo to indacaterol|Once daily via SDDPI
16241837|NCT01070849|Other|educational booklet|"Participants will receive an educational booklet and the advice to return to normal activities as soon as possible from their rehabilitation practitioner in their dismissal examination. As educational booklet the German version of the back book of Burton et al. was chosen. This booklet provides information about the new approach to back pain, causes of back pain, dealing with an attack of back pain, risk factors for development of chronic back pain and the role of activity. All information that is provided is in accordance with actual scientific knowledge and is based on a bio-psycho-social model of back pain like described in Waddell."
16241838|NCT01070849|Other|IRENA|Participants will be introduced into the normal IRENA program (in German: Intensivierte Rehabilitationsnachsorge), which is usual care in Germany. Every patient will be assigned to a certified aftercare facility near their residential area. Aftercare practitioners and patients can compile an individual therapeutic package from certain appointed therapeutic services. Predominantly resistance training, gymnastics, aquatic exercise, back school and recreation exercises are prescribed by the physicians for aftercare. Most therapies are carried out in open access groups of at least 6 patients without being specific for medical indication. In the IRENA program it is possible to pass the intended 24 exercise sessions with different frequency per week. Usually participants do two or three exercise sessions per week with duration of 90 to 120 minutes per session. Every aftercare facility offers certain therapy combinations at different days in week.
16241839|NCT01070849|Other|RÜCKGEWINN|For long term sustainability and the enhancement of intensity of the rehabilitation process this investigational aftercare intervention shows formal and didactic divergences from standard programmes in rehabilitation aftercare. Three important areas for multidimensional interventions are targeted: attitude and behaviour change concerning back pain, guidance to health enhancing physical activity, improvement of health related physical fitness. Every 90 minutes taking exercise session contains parts for mediation of knowledge, for behavioural modulation and for physical exercises and interlocks them in the mediation process. To take the time into account that is necessary for the process of behavioural change RÜCKGEWINN is planned for duration of six months in one session weekly for 26 weeks.
16241840|NCT01070836|Drug|natalizumab|Administered as specified in the treatment arm
16241841|NCT01070823|Drug|Tysabri® (natalizumab)|Prescribed according to the TYSABRI Outreach: United Commitment to Health (TOUCH) Prescribing Program
16241842|NCT01070810|Drug|D5W|Dextrose 5%
16241843|NCT01070810|Drug|Thiamine|Thiamine 200mg in 50ml D5W
16241844|NCT01070797|Biological|Multi-virus Specific T cells|"Subjects will receive Multivirus specific T cells on one of the following dose levels:
~Level One: 5 x 10^6 rCTLs/m2
~Level Two: 1 x 10^7 rCTLs/m2
~Level Three: 2 x 10^7 rCTLs/m2
~Level Four: 5 x 10^7 rCTLs/m2
~If a patient has a partial response (as defined by a 50% fall in viral load) or receives medication (such as steroids) which may affect the persistence or function of the infused CTL they are eligible to receive up to 2 additional doses at the same initial dose. The minimum time between additional doses is 28 days."
16241845|NCT01070784|Drug|Symbicort Turbuhaler (Budesonide/formoterol)|2 x 160/4.5 microgram, inhalation, bid, 52 weeks
16241846|NCT01070784|Drug|Drug: any available COPD treatment; investigator to decide|According to investigator decision, 52 weeks, Standard COPD treatment according to investigator decision
16241847|NCT01070771|Device|Radi pressure wire (pressure wire assessment)|Intracoronary insertion of pressure wire at the time of diagnostic angiography.
16241848|NCT01070758|Drug|Lanreotide autogel|The dose of Lan-ATG will be calculated according to the surface area of the patient. The dose used in adults is usually 60 mg injection once a month, and we will adapt the patient's dose according to the body surface area and also according to the daily dose of Octreotide used with the pump. The starting dose will be 40 mg/m².
16241849|NCT01070745|Drug|Indomethacin|Three doses of intravenous (IV) indomethacin at 0.2 mg/kg/dose given over 30 minutes, at intervals of 12 hours
16241850|NCT01070745|Drug|Ibuprofen|10 mg/kg infused over 30 minutes, followed by two doses of 5mg/kg each at 24 hour intervals
16241851|NCT01070732|Drug|Paracetamol|All patients will receive one single dose of 1000mg paracetamol. If considered mandatory by the attending physician, similar doses may be administered latter for a maximum period of five days. The maximum allowed daily dose is 3000mg. If the attending physician believes that after the administration of at least of three doses the desired analgesic or antipyretic effect is not achieved, he may administer any other compound in his will.
16241852|NCT01070706|Drug|Paclitaxel,Gemcitabine,Sunitinib|"To determine the MTD, only DLT occurring during the first cycle of treatment will be considered. And MTD is defined as the dose level at which at least one-third of patients experience a DLT during their first treatment course. The recommended dose level for the subsequent phase II study is defined as the preceding dose level before the MTD is attained.
~If MTD is not reached, the recommended initial dose of the phase II part will be at the dose of paclitaxel 80 mg/m2 and gemcitabine 1200 mg/m2 (days 1, 8) with sunitinib 37.5 mg qd D2-D15."
16241853|NCT01070693|Procedure|Open mesh inguinal hernia repair|Inguinal hernia repair either with the bilayer mesh or the Lichtenstein technique
16241854|NCT01070693|Device|Prolene Hernia System|Prolene Hernia System
16241855|NCT01070693|Procedure|Lichtenstein technique|Lichtenstein technique
16241856|NCT01070680|Drug|Precedex|mkg/ml,continuous infusion at rate 0.7 µg/kg/h
16241857|NCT01070680|Drug|sodium chlorid 0,9%|continuous intravenous infusion
16241858|NCT01070667|Drug|Dronedarone|400mg orally once per day for 3 months
16241859|NCT01070667|Drug|Placebo|1 tablet once per day for 3 months. The tablet will appear identical to the active dronedarone tablet.
16241860|NCT01070654|Procedure|40/30 recruitment manoeuvre|The ventilator will be switched to the continuous positive airway pressure (CPAP) mode and the pressure will be increased to 40 cmH20 for 30 seconds.
16241861|NCT01070654|Device|continuous positive airway pressure (CPAP)|continuous positive airway pressure (CPAP)
16241862|NCT01070641|Drug|Carvedilol|Carvedilol 12.5mg QD
16241863|NCT01070641|Procedure|Esophageal variceal band ligation|Each patient will undergo for variceal band ligation after 3 weeks till the eradication of varices
16241864|NCT01070628|Drug|Stalevo (levodopa/ carbidopa/ entacapone)|150mg, 125 mg, 100mg, 75mg of levodopa q.i.d. in 3.5 h interval
16241865|NCT01070628|Drug|Sinemet (levodopa/carbidopa)|150 or 100 mg levodopa q.i.d. in 3.5 hr interval
16241866|NCT01070615|Drug|Prucalopride|
16241873|NCT01070524|Drug|Budesonide extrafine pMDI|Budesonide extrafine pMDI
16241874|NCT01070524|Drug|Seretide(r) Evohaler(r)|Seretide(r) Evohaler(r): fixed combination fluticasone/salmeterol
16241875|NCT01070511|Drug|Tadalafil|Tadalafil will be administered orally on two consecutive days. The first dose-10 mg- will be administered the afternoon before the study. The second dose -20 mg-will be administered the morning of the study.
16241876|NCT01070511|Drug|Placebo|A placebo pill will be administered orally on two consecutive days. The first pill will be administered the afternoon before the study. The second pill will be administered the morning of the study.
16241877|NCT01070498|Drug|Trichuris suis ova (TSO)|Subjects will receive TSO every other week for 3 months. The dose will depend on the age of the subject and vary between 100 and 2500 eggs. TSO will be administered orally as a suspension in single dose vials prepared by Ovamed GmbH, a company not directly involved in the study.
16241878|NCT01070485|Drug|Radium-223 chloride (BAY88-8223)|The required volume of study drug to be administered to a patient was calculated using the patient's body weight (50 kBq/kg b.w.).
16241879|NCT01070472|Drug|Misoprostol|titrated oral misoprostol solution
16241880|NCT01070459|Behavioral|Aerobic exercise group|The patients continue their regular therapy in the rehabilitation center. They participate in a 12-week programme of aerobic training 30 minutes/session, using a leg cycle bike. Patients will be trained three times a week. The heartrate will vary from 50 tot 75% of their predicted heart rate. Each patient will be provided with an progressive exercise prescription based on 50-75% of their predicted maximum heartrate. Throughout the training sessions the heart rate will be monitored continuously with a polar pulse rate. Within these 12 week exercise programme four information sessions will be offered to patients and relatives about risk factors of stroke, usefulness of an active lifestyle and healthy eating.
16241881|NCT01070459|Behavioral|Control group|The patients continue their regular therapy in the rehabilitation center. They participate in a 12-week programme of passive mobilisation of the hemiplegic knee, using a continuous passive motion device. Patients will be trained three times a week, 30 minutes/session.
16241882|NCT01070459|Behavioral|Follow-up first aerobic exercise group|The experimental aerobic exercise will be divided in two groups at random after the 12 weeks aerobic exercise programme. The first group will get feedback on how to train further their aerobic capacity within the following 9 months. The second group will not undergo the feedback programme.
16241883|NCT01070459|Behavioral|Follow-up control group|No intervention will be offered in a period of 9 months after the passive mobilisation programme
16241884|NCT01070459|Behavioral|Follow-up second aerobic exercise group|The experimental aerobic exercise will be divided in two groups at random after the 12 weeks aerobic exercise programme. The second group will not undergo the feedback programme. This group will be measured but not treated with an intervention programme
16241885|NCT01070446|Dietary Supplement|Vitamin: Choline Bitartrate (2-hydroxyethyl) trimethylammonium salt 1:1|This is a prospective, repeated measures study involving children with Cystic Fibrosis. Children will be assessed (1) before starting the choline supplement, (2) after taking the supplement for 6 months and after the supplement has been discontinued for 3 months.
16241886|NCT01070433|Drug|MEBO Wound Ointment (MEBO)|Topical application twice a day
16241887|NCT01070433|Other|Standard of Care|Topical application twice a day
16241888|NCT01070420|Other|FFR via central venous line|Patients with intermediate coronary artery stenosis were consecutively enrolled. FFR was measured by a standard intravenous (IV) adenosine infusion (140 μg•min-1•kg-1) via Rt central femoral vein.
16241889|NCT01070420|Other|FFR via peripheral venous line|Patients with intermediate coronary artery stenosis were consecutively enrolled. FFR was measured by a standard intravenous (IV) adenosine infusion (140 μg•min-1•kg-1) via continuous peripheral vein.
16241890|NCT01070407|Biological|Ad6NSmut; AdCh3NSmut|2 doses Ad6NSmut 5 x 10^8vp at weeks 0 and 4 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 24.
16241891|NCT01070407|Biological|Ad6NSmut; AdCh3NSmut|2 doses Ad6NSmut 5 x 10^9vp at weeks 0 and 4 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 24.
16241892|NCT01070407|Biological|Ad6NSmut; AdCh3NSmut|2 doses Ad6NSmut 2.5 x 10^10vp at weeks 0 and 4 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 24.
16241893|NCT01070407|Biological|AdCh3NSmut; Ad6NSmut|2 doses AdCh3NSmut 5 x 10^8vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 24.
16241894|NCT01070407|Biological|AdCh3NSmut; Ad6NSmut|2 doses AdCh3NSmut 5 x 10^9vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 24.
16241895|NCT01070407|Biological|AdCh3NSmut; Ad6NSmut|2 doses AdCh3NSmut 2.5 x 10^10vp at weeks 0 and 4 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 24.
16241896|NCT01070407|Biological|Ad6NSmut; AdCh3NSmut|1 dose Ad6NSmut 2.5 x 10^10vp at week 0 and 1 dose AdCh3NSmut 2.5 x 10^10vp at week 8.
16241897|NCT01070407|Biological|AdCh3NSmut; Ad6NSmut|1 dose AdCh3NSmut 2.5 x 10^10vp at week 0 and 1 dose Ad6NSmut 2.5 x 10^10vp at week 8.
16241898|NCT01070407|Biological|AdCh3NSmut; Ad6NSmut|1 dose AdCh3NSmut 7.5 x 10^10vp at week 0 and 1 dose Ad6NSmut 7.5 x 10^10vp at week 8.
16241899|NCT01070394|Drug|LDX Treatment|30 mg, 50mg, or 70 mg. Oral capsule, once a day, for 12 weeks.
16241900|NCT01070381|Device|nelfilcon A contact lens|Commercially marketed, toric, soft contact lens for daily disposable wear
16241901|NCT01070381|Device|ocufilcon D contact lens|Commercially marketed, toric, soft contact lens for daily disposable wear
16241902|NCT01070368|Other|Commercial extract and in-house wheat extract|Patients with a history of wheat allergy underwent two skin test extracts, and open challenge with wheat. A blood test for specific IgE was performed in the same time.
16241903|NCT01070355|Drug|Eicosapentaenoic acid free fatty acid|An enteric-coated preparation of 99% pure omega-3 polyunsaturated fatty acid (PUFA) eicosapentaenoic acid as the free fatty acid. 500mg capsules, 2 taken twice daily for 2-6 weeks before liver resection.
16241904|NCT01070355|Drug|Placebo|2 capsules taken twice daily for 2-6 weeks before liver resection.
16241905|NCT01070342|Device|Spacelabs 90217|Comparison of the two ways to measure blood pressure: using the ambulatory blood pressure device (Spacelabs 90217) versus the standard method of measuring blood pressure is done by using a stethoscope and a blood pressure cuff.
16241906|NCT01070329|Drug|Duloxetine|Participants received 30 milligrams (mg) duloxetine once daily (QD) by mouth (po) for 1 week, followed by 60 mg QD po for 7 weeks. Participants were given the option to take duloxetine 30 mg QD, po for a 2-week taper phase.
16241907|NCT01070329|Drug|Placebo|Participants received placebo QD, po for 8 weeks, followed by placebo QD, po during the 2-week taper phase.
16241908|NCT01070316|Drug|Everolimus|Everolimus is available in tablet form. The starting dose will be 5 mg/m2/day, rounded to the nearest 2.5 mg/dose, to be taken daily. After two weeks, serum trough level will be measured and dose adjusted according to the following algorithm If Blood trough level is less than 2.5 ng/ml than increase dose by 5 mg/m2/day; If Blood trough level is 2.5-5.0 ng/ml than increase dose by 2.5 mg/m2/day; If Blood trough level is 5.1-10.0 ng/ml than increase dose by 0 mg/m2/day (no change); If Blood trough level is 10.1-15.0 ng/ml than decrease dose by 2.5 mg/m2/day
16241909|NCT01070303|Biological|Adalimumab 40 mg eow or ew|Adalimumab 40 mg by subcutaneous injection every other week or every week
16241910|NCT01070290|Drug|ARQ 197|120 mg capsule administered twice daily
16241911|NCT01070290|Drug|Oxaliplatin, capecitabine or irinotecan|Investigator's choice or oxaliplatin, capecitabine or irinotecan
16241912|NCT01070277|Drug|Tinidazole and Albendazole|Tinidazole 2 gr/daily for 2 days followed by Albendazole 400mg X2 /day for 7 days
16241913|NCT01070277|Drug|Placebo control|"2 placebo pills X2 /day for 2 days followed by
~1 placebo Pill X2 / day for 7 days"
16241914|NCT01070264|Dietary Supplement|Noni Juice|This was an open label three-month intervention pilot study. Data were collected by pre and post intervention survey as well as laboratory testing. Inclusion criteria were: adults of both sexes aged 40 to 75, with a diagnosis of OA on the hip or knee by their primary care physician, not on prescription medicine for OA, and who were willing to drink 3 oz of TNJ a day
16241915|NCT01070251|Behavioral|Participatory parent-focused intervention|Parent workshops and internet-based support to establish healthy physical activity routines, added to existing state-sponsored PA program
16241916|NCT01070251|Behavioral|State-sponsored PA program|Preschool children receive twice a week 60 minutes of physical activity lessons over 6 months by an external gym trainer
16241917|NCT01070238|Dietary Supplement|Isomaltulose|
16241918|NCT01070225|Drug|Hydrocortisone/ Placebo and Propranolol|Hydrocortisone 400mcg Propranolol 10mg or 20 mg
16241919|NCT01070212|Other|soft gum|. Participants will either chew nothing or chew one of the two gum varieties (flavorless soft or hard) at a constant rate (determined by a metronome) for 15 minutes while sipping apple juice through a straw. Appetite will be measured continuously via a slide potentiometer attached to a 100mm gLMS scale. The juice will provide 10% of the participants estimated daily energy requirement (i.e., equal to 1-2 servings of most commercial snacks). It will also contain 10g of lactulose (a soluble, non-absorbable carbohydrate used to assess gastric transit time via analyses of breath hydrogen) and acetaminophen (a marker for gastric emptying).
16241920|NCT01070212|Other|firm gum|. Participants will either chew nothing or chew one of the two gum varieties (flavorless soft or hard) at a constant rate (determined by a metronome) for 15 minutes while sipping apple juice through a straw. Appetite will be measured continuously via a slide potentiometer attached to a 100mm gLMS scale. The juice will provide 10% of the participants estimated daily energy requirement (i.e., equal to 1-2 servings of most commercial snacks). It will also contain 10g of lactulose (a soluble, non-absorbable carbohydrate used to assess gastric transit time via analyses of breath hydrogen) and acetaminophen (a marker for gastric emptying).
16241921|NCT01070212|Other|no gum|. Participants will either chew nothing or chew one of the two gum varieties (flavorless soft or hard) at a constant rate (determined by a metronome) for 15 minutes while sipping apple juice through a straw. Appetite will be measured continuously via a slide potentiometer attached to a 100mm gLMS scale. The juice will provide 10% of the participants estimated daily energy requirement (i.e., equal to 1-2 servings of most commercial snacks). It will also contain 10g of lactulose (a soluble, non-absorbable carbohydrate used to assess gastric transit time via analyses of breath hydrogen) and acetaminophen (a marker for gastric emptying).
16241922|NCT01070199|Behavioral|liquid to liquid|"• One test session will involve presentation of a glass of clear cherry-flavored unthickened beverage (Kool-Aid, Kraft Foods Inc., White Plains, NY). This session will be referred to as the Liquid to Liquid session as the participants will be consuming a liquid and be told that the consistency in their stomach will be a liquid."
16241923|NCT01070199|Behavioral|liquid to solid|This session involves a solution of calcium chloride and a solution of sodium alginate. The participant will be instructed to pour the cherry-flavored beverage/alginate solution into the calcium chloride. The result is a solid mass. They are allowed to examine the solution to confirm the solid texture and consistency.Participants will be told that this same reaction will occur in their stomach when the session's beverage is consumed due to the effect of gastric acid on the solution. But, the participant will be consuming the same cherry-flavored beverage as in the 1st session. Thus, they will believe that their GI tract will be challenged with a solid mass, but in reality, the challenge is the same (i.e., liquid).Therefore, the only difference between the test sessions is expectation.
16241924|NCT01070199|Behavioral|solid to liquid|"• This session will involve the same dense gelatin cubes previously described, but participants will be told that the solid cubes will turn to liquid when they come into contact with the acid in their stomach. This trial will be known as Solid to Liquid. A demonstration of the Solid to Solid and Solid to Liquid phases will be shown to the participant before they consume the load. Both phases exhibited by placing two cubes into separate containers filled with similar looking clear liquids. The Solid to Solid phase container will contain cold water so the cube stays in solid form. The Solid to Liquid phase container will contain hot water that will quickly dissolve the cube into a liquid form."
16241925|NCT01070199|Behavioral|solid to solid|"Participants will be presented with dense gelatin cubes. These 1 x 1 x 1 cubes will have a solid appearance and require mastication, but is isocaloric to the beverage. However, after mastication and gastric processing, the solid rapidly breaks down into a clear fluid.However, participants will be informed that the cubes will remain the same solid consistency in their stomach. The masticatory process and stimulus form will be standardized through the use of a metronome. Participants will be required to chew the solid cube at a fixed rate prior to swallowing. Thus, adding to the cognitive impression that they are eating a solid when essentially the GI challenge will be similar to the beverage."
16241926|NCT01070186|Drug|Sunitinib|50mg/day for 4 weeks
16241927|NCT01070186|Other|Tumor biopsy|Conducted prior to administration of sunitinib therapy
16241928|NCT01070186|Procedure|Nephrectomy|Nephrectomy 2-4 weeks after last dose of Sunitinib
16241929|NCT01070186|Other|Biomarkers|"Biomarker evaluation of blood prior to treatment, after 4 weeks of Sunitinib administration, and every three months for a year after surgery.
~Biomarker evaluation of tissue prior to 4 week administration of Sunitinib"
16241930|NCT01070160|Drug|Endometrin (progesterone 100mg vaginal inserts)|once a day, 6-8 days as specified (prior to each EMBx)
16241931|NCT01070160|Drug|Metformin|per clinical care guidelines
16241932|NCT01070147|Other|Computerized Asthma Management System|The intervention group's clinicians will receive prompts via the computerized management system to prompt them for scoring, assessments, and disposition decisions.
16241933|NCT01070134|Behavioral|Mindfulness-based Behavioural Therapy (MIBT)|"The MIBT treatment consists of weekly individual MIBT therapy (45-50 min.), together with weekly mindfulness-skills training group (1.5 hours).
~The treatment is based on the cognitive model of depression, but will, based on concrete problems, draw from alternative cognitive techniques in order to treat personality-related problems and will use elements from mindfulness."
16241934|NCT01070134|Behavioral|PT (psychodynamic therapy)|"The PT treatment consists of weekly individual PT therapy (45-50 min.), together with weekly PT group therapy (1.5 hours).
~The main elements of PT are the free-flowing, non-therapist guided dialogue, based on classic psychoanalytical free association. Basically, the role of the therapist is to set ground rules and organise the time, place and duration, to maintain a proper tone, and ultimately to ensure that a therapeutic process takes place using relevant interventions."
16241935|NCT01070108|Drug|Ketamine|group receiving one injection (25 mg) of ketamine (K1) intramuscularly (IM) at 3-4 hours before surgery or placebo (saline 0.9%, NS)
16241936|NCT01070108|Drug|ketamine|ketamine at 11-12 hours (10 mg) and 3-4 hours (25 mg) before surgery (K2), with a corresponding NS group
16241937|NCT01070108|Drug|ketamine|ketamine injected IM 17-18, 11-12, and 3-4 hours before surgery (5, 10 and 25 mg, respectively) (K3), and the second group received NS
16241938|NCT01070095|Other|Electronic Asthma Action Plan System|The electronic asthma action plan system consists of a tablet device in the physician waiting room which participants use to complete a simple questionnaire, a computerized clinical decision support system which then processes these data to produce a set of asthma care recommendations for the clinician, and finally, a printable asthma action plan that is given to patients, along with the URL for an asthma education website.
16241939|NCT01070069|Device|PEVAR (ProGlide closure)|Percutaneous EVAR facilitated by the ProGlide closure device
16241940|NCT01070069|Device|SEVAR (IntuiTrak)|Standard vascular exposure for access prior to EVAR
16241941|NCT01070069|Device|PEVAR (Prostar XL closure)|Percutaneous EVAR facilitated by the Prostar XL closure device
16241942|NCT01070056|Behavioral|Therapeutic Lifestyle Changes (MINT-TLC)|This intervention is based on established clinical practice guidelines for prevention and treatment of hypertension(HTN), which recommends weight loss (if overweight), limiting sodium and alcohol intake, regular physical activity, reducing alcohol intake, and eating a low-fat diet that is rich in fruit and vegetables. MINT-TLC will be conducted by trained research personnel. Patients will attend 10 classes over 12 weeks (intensive phase) followed by individual monthly MINT sessions for 3 months (maintenance phase). We chose the intervention schedules to pattern after the methodology of therapeutic lifestyle interventions with proven efficacy in hypertensive patients, specifically, Trial of Nonpharmacologic Approaches in Elderly Hypertensives (TONE) and PREMIER trials.
16241943|NCT01070056|Behavioral|Usual Care|Patients randomized to the Usual Care (UC) condition will receive standard hypertension (HTN) treatment recommendations as determined by their physicians. In addition, they will receive a 30-minute individual counseling session on therapeutic lifestyle modification, similar to PREMIER. We feel obligated ethically to provide this minimal intervention to patients in the UC group given that counseling on TLC is a standard recommendation for treatment of hypertension. To match the MINT-TLC group for content of intervention material, those in the UC group will receive print versions of the intervention materials.
16241944|NCT01070043|Drug|Amlodipine 5mg/Valsartan 80 mg|Combination therapy of Amlodipine/Valsartan 5mg/80mg one dosage daily with one single tablet size for 8 weeks.
16241945|NCT01070043|Drug|Valsartan|"For run-in period, Valsartan 80 mg daily in one dosage with one single tablet size for 4 weeks.
~Monotherapy for double blind treatment period in one dosage (Valsartan 160mg) daily with one single tablet size for 8 weeks"
16241946|NCT01070030|Drug|Aliskiren/Amlodipine (150/5 mg/day, 300/10 mg/day) , Aliskiren/Amlodipine/Hydrochlorothiazide (300/10/12.5 mg/day, 300/10/25 mg/day)|The patients were asked for 2 week run-in phase with atenolol 50 mg qd(once a day), followed by 4 schedule visits with 4-week interval until patient achieved BP goal. The maximum follow up was 16-week treatment. At visit 2, the patients started receiving Aliskiren/Amlodipine (150/5mg per day) for 4 weeks. At visit 3, if the patients did not achieve blood pressure (BP) goal, patients were up titrated to Aliskiren/Amlodipine (300/10 mg/day) for 4 weeks. At visit 4, if the patients did not achieve BP goal, HCT 12.5 mg/day was added to Aliskiren/Amlodipine/HCT (300/10/12.5 mg/day) for 4 weeks. Finally at visit 5, if the patients did not achieve BP goal, HCT was up titrated to Aliskiren/Amlodipine/HCT (300/10/25 mg/day) for 4 weeks until visit 6. Once the patients achieved BP goal at any visit, they completed the study.
16241947|NCT01070017|Other|DOT-HAART|For 8 months, DOT-HAART of all doses in the participant's home or alternate location. DOT worker ensures that HIV medications are taken as indicated and witnesses ingestion of all medications including other medications prescribed by physician. The worker will be trained to identify, triage and notify providers of any psychosocial and medical problems/complications. Transition to self-administration begins in months 9-12 when DOT will be tapered and greater participation of treatment supporter to prepare patients for self-administration.
16241948|NCT01070004|Other|Real driving situation|Continuous blue light exposure during driving compared to effects of coffee (2*200 mg of caffeine) and coffee placebo on 4h night-time real driving situation. Inside this arm, each volunteer will be randomly allocated and will all receive : continuous blue light exposure, coffee and coffee placebo at each driving session with at least 1 week between each condition.
16241949|NCT01070004|Other|Driving simulator|15 minutes of physical activity at a low intensity before driving compared to effects of coffee (2*200 mg of caffeine) and coffee placebo on 4h night-time driving simulator. Inside this arm, each volunteer will be randomly allocated and will all receive : 15 minutes of physical activity, coffee and coffee placebo at each driving session with at least 1 week between each condition.
16241950|NCT01069991|Behavioral|Patient education group|Patient education delivered to high school students with persistent asthma in group and individual sessions. Academic detailing was also provided to the students' primary care providers.
16241951|NCT01069991|Behavioral|Wait list control group|No intervention was provided for this group until the one year study period was completed, and then the patient education intervention was provided.
16241952|NCT01069965|Drug|BGP-15 100 mg QD|Two 50 mg BGP-15 capsules by mouth in the morning; and two Placebo capsules by mouth in the evening
16241953|NCT01069965|Drug|BGP-15 100 mg BID|One 100 mg BGP-15 capsule by mouth in the morning; and one 100 mg BGP-15 capsule by mouth in the evening
16241954|NCT01069965|Drug|Placebo BID|Two Placebo capsules by mouth in the morning; and two Placebo capsules by mouth in the evening
16241955|NCT01069965|Drug|BGP-15 200 mg QD|Two 100 mg BGP-15 capsule by mouth in the morning; and two Placebo capsule by mouth in the evening
16241956|NCT01069965|Drug|BGP-15 200 mg BID|Two 100 mg BGP-15 capsules by mouth in the morning; and two 100 mg BGP-15 capsules by mouth in the evening
16241957|NCT01069965|Drug|BGP-15 400 mg QD|Two 200 mg BGP-15 capsules by mouth in the morning; and two Placebo capsules by mouth in the evening
16241958|NCT01069952|Device|Deep Brain Stimulation System|In DBS, thin wires are used to carry electric current to the parts of the brain involved in depression symptoms. These wires are implanted surgically and are attached to battery operated stimulators usually implanted in the chest. The study doctor will adjust the settings of the electrical stimulation to optimize treatment for each participant.
16241959|NCT01069939|Drug|Esomeprazole|20mg, capsule, 72 weeks
16241960|NCT01069939|Drug|Placebo|Placebo, capsule, 72 weeks
16241961|NCT01069926|Drug|AZD1656|Single dose oral tablet
16241962|NCT01069913|Drug|BG00012|"Sequence 1: Oral 240 mg BG00012 Standard Formulation & Following 7 day washout period, 240 mg BG00012 API.
~Sequence 2: 240 mg BG00012 API & Following 7 day washout period, 240 mg BG00012 Standard Formulation."
16241963|NCT01069900|Drug|Moxifloxacin (Avelox, BAY12-8039)|For subjects 12 to less than (<) 18 years of age and weighing at least 45 kilograms (kg), the dose of moxifloxacin will be 400 milligrams (mg), once daily (OD). Subjects 12 to < 18 years of age and weighing less than 45 kg, the dose of moxifloxacin will be 4 mg/kg twice daily (BID), every 12 hours (q12h), not exceeding 400 mg/day. Subjects 6 to < 12 years of age the dose of moxifloxacin will be 4mg/kg, q12h, not exceeding 400 mg/day. Subjects 2 to less than 6 years of age the dose of moxifloxacin will be 5mg/kg, q12h, not exceeding 400 mg/day. Subjects 3 months to less than 2 years of age the dose of moxifloxacin will be 6mg/kg q12h IV, not exceeding 400 mg/day. Subjects who were switched from IV to PO therapy, 400 mg or 50 mg moxifloxacin tablets were provided.
16241964|NCT01069900|Drug|Ertapenem|For subjects 13 to <18 years of age, the dosage of ertapenem was 1 gram (g) OD. For subjects 3 months to < 13 years of age, the dosage was 15 mg/kg q12h not to exceed 1 g/day.
16241965|NCT01069900|Drug|Amoxicillin/Clavulanate|Subjects 2 years to < 18 years of age who were switched from IV to PO therapy receive amoxicillin/clavulanate suspension. The dosage of clavulanate was 3.2 mg/kg q12h. (maximum dose of clavulanate was 125 mg q12h). The dosage of amoxicillin was 22.5 mg q12h (a maximum dose of 875 mg amoxicillin q12h must not be exceeded).
16241966|NCT01069900|Drug|Moxifloxacin placebo|Sterile 0.9% sodium chloride solution intended for IV use was used as the placebo for IV moxifloxacin. Tablets containing inactive ingredients were used as the placebo for PO moxifloxacin 400 mg and 50 mg tablets.
16241967|NCT01069900|Drug|Ertapenem placebo|Sterile 0.9% sodium chloride solution intended for IV use was used as the placebo for IV ertapenem.
16241968|NCT01069900|Drug|Amoxicillin/Clavulanate placebo|Suspension containing inactive ingredients was used as the placebo for PO amoxicillin/clavulanate suspension.
16241969|NCT01069874|Dietary Supplement|Cholecalciferol (Vitamin D/Vigantol oil)|Cholecalciferol will be administered as 2-monthly oral bolus doses of Vigantol oil over a period of one year
16241970|NCT01069874|Dietary Supplement|Miglyol oil|Miglyol oil will be administered as 2-monthly oral bolus doses of Miglyol oil over a period of one year
16241971|NCT01069861|Drug|sildanefil|Intravenous sildenafil citrate will be administered as a loading dose of 0.1 mg/kg given over 30 minutes. This will be followed by a maintenance treatment consisting of an intravenous infusion of 0.03 mg/kg/hr. The duration of the infusion will be determined by the need of the individual patient, but will be reviewed at Day 7 if still ongoing, and will not continue past Day 14.
16241972|NCT01069848|Device|Vedera KXS|One treatment session with Vedera KXS
16241973|NCT01069822|Drug|AZD6765|IV solution
16241974|NCT01069822|Drug|midazolam|
16241975|NCT01069809|Biological|AGS-004|HIV-1 Immune Therapy
16241976|NCT01069809|Biological|Placebo|Inactive Placebo Injection
16241977|NCT01069796|Drug|Paclitaxel|80 mg/m² weekly
16241978|NCT01069796|Drug|Bevacizumab|10 mg/kg d1 d15
16241979|NCT01069796|Drug|Capecitabine|800 mg/m² p.o. twice a day, D1 to D5 week 1, 2 & 3
16241980|NCT01069783|Drug|A3309|A3309 in two different dosage levels
16241981|NCT01069783|Drug|A3309|A3309 in two different dosage levels for the duration of the study
16241982|NCT01069783|Drug|Placebo|Placebo comparator once daily for the duration of the trial
16241983|NCT01069770|Drug|Sunitinib|50mg daily(4 weeks on & 2 weeks off), 2 cycles, until progression or unacceptable toxicity develops
16241984|NCT01069757|Drug|ARQ 197 and Erlotinib|Orally twice daily administration of ARQ 197 and orally once daily administration of erlotinib hydrochloride
16241985|NCT01069705|Drug|Tobramycin inhalation powder|Tobramycin dry powder for inhalation in capsules administered by the T-326 inhaler.
16241986|NCT01069692|Drug|SBR759A|SBR759A 6g daily
16241987|NCT01069692|Drug|SBR759A|Placebo Comparator 0g daily
16241988|NCT01069692|Drug|SBR759A|SBR759A 3g daily
16241989|NCT01069692|Drug|SBR759A|9g daily
16241990|NCT01069692|Drug|SBR759A|12g daily
16241991|NCT01069653|Biological|HLA-A*2402-restricted CDCA1 and KIF20A peptides|Escalating doses of every peptide will be administered by subcutaneous injection on days 1, 8, 15 and 22 of each treatment cycle. Planned doses of peptides are 1.0mg, 2.0mg and 3.0mg.
16241992|NCT01069640|Biological|HLA-A*0201 or HLA-A*0206-restricted URLC10 peptides|Escalating doses of every peptide will be administered by subcutaneous injection on days 1, 8, 15 and 22 of each treatment cycle. Planned doses of peptides are 1.0mg, 2.0mg and 3.0mg.
16241993|NCT01069627|Drug|bevacizumab [Avastin]|15 mg/kg intravenously on day 1 of every 3 week cycle
16241994|NCT01069627|Drug|fotemustine|100 mg/m² intravenously on Days 1, 8, and 15, followed by 4 weeks of rest, then every 21 days up to 4 to 6 cycles
16241995|NCT01069614|Device|TopClosure 3S System|
16241996|NCT01069601|Biological|Focetria (2x H1N1 vaccine with MF59 adjuvants)|7,5µg H1N1sw monovalent vaccine with MF59 adjuvants; two doses 3 weeks apart
16241997|NCT01069575|Biological|HLA-A*2402restricted URLC10, CDCA1, and KIF20A peptides|Escalating doses of every peptide will be administered by subcutaneous injection on days 1, 8, 15 and 22 of each treatment cycle. Planned doses of peptides are 1.0mg, 2.0mg and 3.0mg.
16241998|NCT01069562|Other|Conventional control|The isoflurane administration to deliver anesthesia will be done conventionally through a Tec 7 vaporiser to maintain the bispectral index at 50.
16241999|NCT01069562|Other|Closed loop control|The isoflurane administration to maintain anesthesia will be by infusion to the anesthesia circuit using syringe pump (injection technique). The rate of delivery of isoflurane will be regulated by computer that uses a control algorithm.
16242000|NCT01069536|Drug|metoclopramide 10 mg|
16242001|NCT01069523|Drug|Guanfacine Extended Release|Guanfacine is an alpha-2A agonist which is given one a day. the dose range is 1-4 mg. It is a tablet.
16242002|NCT01069523|Drug|Placebo|Table that match the 1 mg Guanfacine Extended Release Tablet. They are dosed once a day.
16242003|NCT01069510|Drug|Spironolactone 25mg|Spironolactone 25 mg daily for 12 months
16242004|NCT01069510|Other|Placebo|Placebo daily for 12 months
16242005|NCT01069497|Other|Prevention of infections program|"The intervention mainly involves implementing urinary, respiratory and gastrointestinal infection prevention measures. Study nursing home medical coordinators will be in charge of training their own teams. For this, they will be provided with:
~a slide-show of recommendations (commented by an expert),
~recommendations guides (on paper and on computer) to be shown to their teams. Means will be provided to the intervention nursing homes : Hydro-alcoholic solutions, disinfectant detergent-impregnated tissues, mouth care kits, tec."
16242006|NCT01069484|Other|Postpartum pelvic floor muscle training|Beyond a customary leaflet and thorough initial instruction on how to contract the PFM correctly, the training participants will attend one weekly supervised exercise class led by an experienced physiotherapist, and perform daily training at home. The intervention starts 6-8 weeks postpartum and last for 4 months. General principles for strength training are followed: 3 sets of 8-12 contractions close to maximum (Bø 1990, Haskell 2007). Emphasis will be on progression in force development. The participants are provided with a DVD of the program (www.corewellness.co.uk). At week 4 during the intervention, the PFM strength will be assessed for each participant. Training adherence at home will be recorded in a training diary, whereas the physical therapist will record group session adherence.
16242007|NCT01069471|Biological|Shigella vaccine|Two intramuscular injections of bioconjugate vaccine will be administrated at D0 and D60.
16242008|NCT01069458|Other|The high protein diet group and the low fat diet group|The High Protein Diet Group was advised to have 25 energy percent from protein, 55 energy percent from fat, 20 energy percent from carbohydrate in the diet and the Low Fat Diet Group was advised to have 30 energy percent from fat, 20 energy percent from protein, 50 energy percent from carbohydrate in the diet.
16242009|NCT01069445|Dietary Supplement|VSL#3® probiotic blend|Product should be administrated orally, 2 capsules b.i.d. on an empty stomach (at least 30 min. before lunch and dinner) with a glass of water
16242010|NCT01069445|Dietary Supplement|AISA-5203-L fruit extracted terpene|Product should be administrated orally, the dosage depending from the body weight of the subject enrolled in the study as already stated : 1-2 pills three times a day with a meal and a large glass of water
16242011|NCT01069445|Dietary Supplement|Argan oil|Product should be administrated orally, 25 ml once daily or during the day with a meal (bread, salad …) and a large glass of water
16242012|NCT01069445|Behavioral|Optimal Diet|a dietician will train each subject (or the caregiver) to use the personalized diet on web platform.
16242013|NCT01069432|Other|No Intervention|No Intervention
16242014|NCT01069393|Other|DAFNE course (Timing of delivery of education)|Education delivered over one day a week for 5 consecutive weeks, as opposed to 5 consecutive days over 1 week.
16242015|NCT01069367|Biological|Emulsion, Cell Culture-based, influenza HA vaccine H1N1|Cell-derived A/H1N1 influenza HA vaccine (0.25 mL as injection volume)
16242016|NCT01069354|Device|Radiesse® Injectable Dermal Filler with Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier with 3% lidocaine hydrochloride (HCl)
16242017|NCT01069354|Device|Radiesse® Injectable Dermal Filler without Lidocaine|Calcium hydroxylapatite particles suspended in an aqueous-based gel carrier without 3% lidocaine hydrochloride (HCl)
16242018|NCT01069341|Drug|Ranibizumab|Intravitreally administered 0.5mg ranibizumab, 3 doses administered monthly.
16242019|NCT01069328|Drug|Nexavar (Sorafenib, BAY43-9006)|Sorafenib 200 mg orally BID interrupted dosing
16242020|NCT01069328|Drug|Nexavar (Sorafenib, BAY43-9006)|Sorafenib 400 mg orally BID interrupted dosing
16242021|NCT01069328|Drug|Bevacizumab|Bevacizumab 2.5 mg/kg intravenously
16242022|NCT01069328|Drug|Bevacizumab|Bevacizumab 5 mg/kg intravenously
16242023|NCT01069328|Drug|Bevacizumab|Bevacizumab 7.5 mg/kg intravenously
16242024|NCT01069328|Drug|Bevacizumab|Bevacizumab 10 mg/kg intravenously
16242025|NCT01069328|Drug|Paclitaxel|Paclitaxel 200 mg/m² intravenously
16242026|NCT01069328|Drug|Carboplatin|Carboplatin AUC 6 intravenously
16242027|NCT01069315|Procedure|Type of fluid lavage solution|Comparison of castile soap solution vs. normal saline solution.
16242028|NCT01069315|Procedure|Type of fluid lavage pressure|Comparison of low pressure vs. high pressure.
16242029|NCT01069302|Drug|Clopidogrel|Clopidogrel loading 600mg and maintenance 150mg for 7days
16242030|NCT01069302|Drug|Clopidogrel|Clopidogrel loading 600mg and maintenance 75mg for 7days
16242031|NCT01069302|Drug|Clopidogrel|Clopidogrel loading 300mg and maintenance 150mg for 7days
16242032|NCT01069302|Drug|Clopidogrel|Clopidogrel loading 300mg and maintenance 75mg for 7days
16242033|NCT01069289|Drug|Budesonide/formoterol (Symbicort Turbuhaler)|2x160/4.5 microgram, inhalation, twice daily, 12 weeks
16242034|NCT01069289|Drug|Formoterol (Oxis Turbuhaler)|2 X 4.5 microgram, inhalation, twice daily, 12 weeks
16242035|NCT01069276|Other|No intervention in this study|No intervention in this study
16242036|NCT01069263|Other|Hyperbaric Oxygen Therapy|60 treatments (12 weeks - 5 days a week) of hyperbaric (pressure of 2 atmospheres) with 100% oxygen inhalation.
16242037|NCT01069263|Drug|DMSO|50 mls of 50% DMSO instilled once a week to the urinary bladder for 12 consecutive weeks.
16242038|NCT01069250|Other|There are no interventions in this study|
16243452|NCT01058083|Drug|BMS-770767|Active, Oral, 50 mg BID, Daily, 28 days
16242041|NCT01069198|Drug|Albendazole, Iron, Zinc and Vitamin A|single oral dose of 200,000 IU Vitamin A at baseline and after six months, 35 mg and 65 oral elemental iron for subject aged <5 and >=5 years respectively everyday for two months starting from enrollment; 10 mg oral zinc for 10 consecutive days each month for 6 months; and a single 400 mg oral dose of albendazole at 3-months' intervals.
16242042|NCT01069198|Other|Placebo|Placebo
16242043|NCT01069185|Procedure|Necessity endotracheal suctioning|Endotracheal suctioning depends on clinical manifestations
16242044|NCT01069185|Procedure|Routine endotracheal suctioning|Endotracheal suctioning every two hours
16242045|NCT01069172|Device|FS Laser Surgery|The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery to perform capsulotomy, lens segmentation, and lens softening, which are all part of cataract surgery when this femtosecond laser is used.
16242046|NCT01069172|Procedure|CCC Surgery|Subjects will receive the standard of care for CCC and U/S cataract surgery to facilitate removal of the crystalline lens. CCC is a procedure that is part of cataract surgery.
16242047|NCT01069159|Drug|Propranolol Hydrochloride|The protocol of the study requires that two doses of propranolol (regular propranolol 40 mg followed two hours later by long-acting propranolol 60 mg) or placebo be given at the first visit, to be taken within one hour of the reactivation of the traumatic memory. Subjects will be randomized in a 1:1 ratio to either Propranolol treatment or placebo.
16242048|NCT01069159|Drug|Placebo|The protocol of the study requires that two doses of placebo be given at the first visit, to be taken within one hour of the reactivation of the traumatic memory. Half of the subjects (33) will be randomized to receive placebo.
16242049|NCT01069146|Procedure|Mild therapeutic hypothermia induction|Mild Therapeutic hypothermia was induced immediately after patient inclusion. Patients were cooled between 32 and 34°c (33 ± 1°C; 90 and 93°F) for 36 hours, using the automatic mode of an external water cooling blanket (Meditherm II®, Gaymar, Orchard Park, NY, USA). The machine constantly compares actual patient temperature (measured by a rectal probe) with the set point, and automatically adjusts the blanket water temperature so that the desired patient temperature is achieved. The target temperature was to be reached within eight hour following inclusion. Rewarming was only passive (blanket switched off), and paralytic agents were to be stopped when the body temperature reached back 36°C (97°F).
16242050|NCT01069133|Drug|Rifaximin|550mg BID open-label
16242051|NCT01069133|Drug|rifaximin|550mg PO BID
16242052|NCT01069120|Drug|Proellex|2, 25 mg capsules once per day
16242053|NCT01069120|Drug|Proellex|1, 25 mg capsule once per day
16242054|NCT01069107|Other|Cottage Hospital Care|Care at a cottage hospital compared with care at a general hospital
16242055|NCT01069094|Drug|Progenta|12.5 mg, administered as a once daily oral dose for 90 days.
16242056|NCT01069094|Drug|Progenta|25 mg, administered as a once daily oral dose for 90 days.
16242057|NCT01069094|Drug|Progenta|50 mg, administered as a once daily oral dose for 90 days.
16242058|NCT01069094|Drug|Lucron Depot|3.75 mg IM monthly
16242059|NCT01069094|Drug|Placebo|Administered as a once daily oral dose for 90 days.
16242060|NCT01069081|Drug|Arm C|Docetaxel and cisplatin chemotherapy combined with high dose PPI. Docetaxel 75mg/m2 intravenous d1, cisplatin 75mg/m2 intravenous d1,repeated every 3 weeks.Each patient is designed to receive no more than 6 cycles of chemotherapy.PPI 200mg p.o. d1-3 every week for 66 weeks.
16242061|NCT01069081|Drug|Arm B|Docetaxel and cisplatin chemotherapy combined with lower dose PPI. Docetaxel 75mg/m2 intravenous d1, cisplatin 75mg/m2 intravenous d1,repeated every 3 weeks.Each patient is designed to receive no more than 6 cycles of chemotherapy.PPI 160mg p.o. d1-3 every week for 66 weeks.
16242062|NCT01069081|Drug|Arm A|Docetaxel and cisplatin chemotherapy. Docetaxel 75mg/m2 intravenous d1, cisplatin 75mg/m2 intravenous d1,repeated every 3 weeks.Each patient is designed to receive no more than 6 cycles of chemotherapy.
16242063|NCT01069055|Other|Sterile Saline|Group I: 100 ml intravenous saline infusion as placebo 30 minitues before the surgery.
16242064|NCT01069055|Drug|Intravenous lornoxicam|Group II: 8 mg intravenous lornoxicam infusion in 100 ml saline 30 minitues before the surgery.
16242065|NCT01069055|Drug|Intravenous paracetamol|Group III: 1 g intravenous paracetamol infusion in 100 ml saline 30 minitues before the surgery.
16242066|NCT01069042|Drug|Enalapril|All subjects will initially receive 10mg of enalapril and be gradually titrated up to 20mg with blood pressure tolerance for 6 months.
16242067|NCT01069016|Procedure|Sacral nerve modulation|For one week the sacral nerve is continuously stimulated by an external pulse generator. Strength of stimulation can be adjusted by the patient.
16242068|NCT01069016|Procedure|Pudendal nerve stimulation|For one week the pudendal nerve is continuously stimulated by an external pulse generator. Strength of stimulation can be adjusted by the patient.
16242069|NCT01069003|Drug|Placebo Arm|Placebo and ASA (75 mg - 325 mg)
16242070|NCT01069003|Drug|Thienopyridine Therapy|Prasugrel 5 or 10 mg or Clopidogrel 75 mg plus ASA (75 mg - 325 mg)
16242071|NCT01069003|Device|Surveillance Arm|Non randomized arm to understand clinical outcomes in a commercial setting
16242072|NCT01068977|Drug|bevacizumab|Repeating intravenous dose
16242073|NCT01068977|Drug|MetMAb|Repeating escalating intravenous dose
16242074|NCT01068977|Drug|MetMAb|Repeating intravenous dose
16242075|NCT01068964|Drug|0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution|One drop from each bottle, administered once daily in the evening for 4 weeks Bottle 1: 0.03% Bimatoprost/0.5% Timolol Ophthalmic Solution Bottle 2: Vehicle Ophthalmic Solution
16242076|NCT01068964|Drug|0.03% Bimatoprost Ophthalmic Solution and 0.5% Timolol Ophthalmic Solution|One drop from each bottle, administered once daily in the evening for 4 weeks Bottle 1: 0.03% Bimatoprost Ophthalmic Solution Bottle 2: 0.5% Timolol Ophthalmic Solution
16242077|NCT01068951|Biological|Mesenchymal stem cells|Autologous transplantation of the patients own mesenchymal stem cells (approximately 2 x 106 cells/kg body weight) intravenously.
16242078|NCT01068938|Device|three different perimeters: HFA, Octopus, MATRIX|visual fields
16242079|NCT01068925|Drug|GSK1349572|"GSK1349572 QD x 5 days
~TPV/RTV 500/200mg BID x 7 days
~GSK1349572 50mg QD and TPV/RTV 500/200mg BID x 5 days"
16242080|NCT01068912|Drug|Favipiravir|1000 mg favipiravir BID x 1 day, and 400 mg favipiravir BID x 4 days
16242081|NCT01068912|Drug|Favipiravir|High-dose favipiravir regimen: 1200 mg favipiravir BID x 1 day, and 800 mg favipiravir BID x 4 days
16242082|NCT01068912|Drug|Placebo comparator|Placebo BID x 1 day, and Placebo BID x 4 days
16242083|NCT01068886|Procedure|External pancreatic stent|stent through pancreatic anastomosis
16242084|NCT01068873|Drug|lopinavir/ritonavir plus maraviroc|Lopinavir/ritonavir 400 mg/100 mg two tablets twice daily with Maraviroc 150 mg one tablet twice daily will be administered for 48 weeks to participants meeting entry criteria.
16242085|NCT01068860|Drug|Canakinumab 150 mg|Single subcutaneous injection of Canakinumab 150 mg.
16242086|NCT01068860|Drug|Placebo to Canakinumab|Single subcutaneous injection of Placebo to Canakinumab.
16242087|NCT01068847|Drug|2-4 of the drugs listed below|Cycloserine: 500, 675, 750 mg oral capsules may possibly given. Naloxone: 0.15mg/70Kg or 0.2mg/70kg I.M. injection may possibly be given. Nifedipine: 10, 20 mg oral capsules may possibly be given. Placebo (sugar pill or microcrystalline cellulose): oral capsules may be given. Saline: I.M. injection may possibly be given. Tizanidine: 4, 8, 12 mg oral capsules may possibly be given. Verapamil: 30, 60, 120 mg oral capsules may possibly be given.
16242088|NCT01068834|Genetic|KIF6 genetic test|KIF6 carrier status with interpretation sheet provided to subject
16242089|NCT01068821|Other|Gel pad|A gel pad (mattress) (approximately 3cm thick) is placed under the patient on top of the usual operating room mattress, directly in contact with patient's skin from buttocks to shoulders with the patient in dorsal lithotomy position under general anesthesia. Time in Trendelenburg's position and time operating are both recorded. The position of two bony landmarks (left anterior superior iliac spine and left acromioclavicular joint) are marked before Trendelenburg's position (30 to 45 degrees below horizontal) and immediately after returning the patient to horizontal position.
16242090|NCT01068821|Other|Egg crate foam mattress|An egg-crate foam mattress (approximately 5cm thick) is placed under the patient on top of the usual operating room mattress, directly in contact with patient's skin from buttocks to shoulders with the patient in dorsal lithotomy position under general anesthesia. Time in Trendelenburg's position and time operating are both recorded. The position of two bony landmarks (left anterior superior iliac spine and left acromioclavicular joint) are marked before Trendelenburg's position (30 to 45 degrees below horizontal) and immediately after returning the patient to horizontal position.
16242091|NCT01068808|Procedure|skin prick test|skin prick test to aeroallergen
16242092|NCT01068795|Drug|enoxaparin|enoxaparin dosage will be adjusted according to anti-factor Xa plasma levels
16242093|NCT01068782|Drug|XL184|given orally as capsules
16242094|NCT01068769|Drug|regorafenib|Taken orally, once a day in the morning for 3 weeks followed by a one week rest period
16242095|NCT01068756|Drug|Dapagliflozin|Tablets, Oral, 10 mg, 2 single oral 10 mg doses, 2 days
16242096|NCT01068756|Drug|Rifampin|Capsules, Oral, 600 mg, Once daily on days 4 to 11, 8 days
16242097|NCT01068743|Drug|saxagliptin|Tablets, Oral, 2.5 mg, once daily, single dose
16242098|NCT01068743|Drug|metformin|Tablets, Oral, 850 mg, once daily, single dose
16242099|NCT01068743|Drug|saxagliptin + metformin (FDC tablet)|Tablet, oral, (saxagliptin 2.5 mg) (metformin 850 mg), once daily, single dose
16242100|NCT01068730|Drug|metformin (Diabex)|Tablets, Oral, 500 mg, Once daily, single dose
16242101|NCT01068730|Drug|metformin (Glucophage™)|Tablets, Oral, 500 mg, Once Daily, single dose
16242102|NCT01068730|Drug|metformin (Glucophage™)|Tablets, Oral, 1000 mg, Once daily, single dose
16242103|NCT01068730|Drug|metformin (Diabex)|Tablets, Oral, 1000 mg, Once daily, single dose
16242104|NCT01068717|Drug|Saxagliptin, 2.5 mg + Metformin, 500 mg (fasted state)|Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week
16242105|NCT01068717|Drug|Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fasted state)|Tablets, oral, 2.5-mg saxagliptin/500-mg metformin fixed-dose combination (FDC), once daily, 1 week
16242106|NCT01068717|Drug|Saxagliptin, 2.5 mg + Metformin, 500 mg (fed state)|Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin, once daily, 1 week
16242107|NCT01068717|Drug|Saxagliptin, 2.5 mg /Metformin, 500 mg FDC (fed state)|Tablets, oral, 2.5-mg saxagliptin and 500-mg metformin FDC, once daily, 1 week
16242108|NCT01068704|Drug|BMS-690514|Tablets, Oral, 200 mg, once daily, ~ 12 months depending on response
16242109|NCT01068704|Drug|Lapatinib|Tablets, Oral, 1500 mg, once daily, ~ 12 months depending on response
16242110|NCT01068704|Drug|Letrozole|Tablets, Oral, 2.5 mg, once daily, ~ 12 months depending on response
16242111|NCT01068691|Procedure|Ambulatory blood pressure monitoring (to evaluate the level of blood pressure)|"Ambulatory blood pressure monitoring (to evaluate the level of blood pressure)
~Blood pressure
~Obstructive sleep apnea syndrome (OSAS)
~Carotid-to-femoral pulse wave velocity (PWV)
~Biological parameters"
16242112|NCT01068678|Drug|insulin degludec|Injected subcutaneously (under the skin) three times weekly. Dose was individually adjusted.
16242113|NCT01068678|Drug|insulin glargine|Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.
16242114|NCT01068665|Drug|insulin degludec|Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.
16242115|NCT01068665|Drug|insulin glargine|Injected subcutaneously (under the skin) once daily. Dose was individually adjusted.
16242116|NCT01068652|Drug|insulin detemir|Initial dose of 0.1 U/kg once daily, injected s.c. (under the skin).
16242117|NCT01068652|Drug|insulin aspart|Pending evaluation of HbA1c every 3 months, insulin aspart was added to the insulin detemir treatment (up to three does daily, injected s.c. (under the skin)
16242118|NCT01068652|Drug|biphasic insulin aspart 30|Initial dose of 0.1 U/kg once daily, injected s.c. (under the skin). Pending evaluation of HbA1c every 3 months, the dose will intensified up to 3 doses daily
16242119|NCT01068652|Drug|metformin|1000-2000 mg/day in combination with insulin treatment
16242120|NCT01068639|Behavioral|No treatment given|No treatment given to study participants, only behaviorial patterns with respect to treatment compliance is observed.
16242121|NCT01068626|Drug|Rosuvastatin|10 mg once daily
16242122|NCT01068626|Drug|Placebo for rosuvastatin|once daily
16242123|NCT01068613|Drug|QAX028|QAX028 60 mcg via inhalation device
16242124|NCT01068613|Drug|QAX028|QAX028 20 mcg via inhalation device
16242125|NCT01068613|Drug|Tiotropium|Tiotropium via inhalation device
16242126|NCT01068613|Drug|Placebo|Placebo to QAX028 via inhalation device
16242127|NCT01068600|Drug|Indacaterol|Once daily via single-dose dry powder inhaler (SDDPI)
16242129|NCT01068587|Drug|MET/VEGFR2 inhibitor Foretinib|"PhaseI and Phase II Arm A:
~Foretinib PO daily dosing starting cycle 1 day 15 and erlotinib PO daily dosing starting cycle 1 day 1. Recommended Phase II dose to be determine in Phase I."
16242130|NCT01068587|Drug|erlotinib hydrochloride|erlotinib PO daily dosing starting cycle 1 day 1. Recommended Phase II dose to be determine in Phase I.
16242131|NCT01068587|Other|laboratory biomarker analysis|Tumour markers alone cannot be used to assess objective tumour response. If markers are initially above the upper normal limit, however, they must normalize for a patient to be considered in complete response
16242132|NCT01068574|Other|BASIC Score (Observational)|The BASIC Score will be assessed by a study staff, but there are no interventions.
16242133|NCT01068561|Biological|intravitreal injection of autologous bone marrow stem cells|One intravitreal injection of a 0.1-ml cell suspension containing around 10x106 bone marrow mononuclear stem cells(BMMSC). All treatments were performed by a single retinal specialist using topical proparacaine drops under sterile conditions (eyelid speculum and povidone-iodine). Autologous BMMSC were injected into the vitreous cavity using a 27 gauge needle inserted through the inferotemporal pars plana 3.0 - 3.5 mm posterior to the limbus. After the injection, central retinal artery perfusion was confirmed with indirect ophthalmoscopy. Patients were instructed to instill one drop of 0.3% ciprofloxacin into the injected eye four times daily for 1 week after the procedure.
16242134|NCT01068548|Other|reminder|computer based reminder to change patients from IV to oral antibiotics based on evidence based clinical practice guidelines
16242135|NCT01068522|Device|Parenchymal Intracranial pressure monitor|Treatment based on readings from Parenchymal intracranial pressure monitor.
16242136|NCT01068522|Other|Treatment based on clinical and imaging observations|Treatment based on clinical and imaging observations.
16242137|NCT01068509|Biological|Cvac|Cvac consists of autologous dendritic cells (DCs) incubated with the antigen, mannosylated fusion protein (M-FP), to target the DCs to the specific mucin 1 antigen.
16242138|NCT01068483|Drug|BKM120|
16242139|NCT01068444|Drug|Pioglitazone|"Name: GLITOS（Pioglitazone）
~Dosage form: Tablets
~Dose(s): 30mg
~Dosing schedule: QD
~Duration: 6 months"
16242140|NCT01068444|Drug|placebo|placebo 30 mg/d for 6 months
16242141|NCT01068431|Other|bandaging with trico as active controller|In general non-elastic bandaging is the compression treatment in lymphedema
16242142|NCT01068418|Dietary Supplement|Vitamin D (cholecalciferol)|cholecalciferol 15,000 IU daily for 30 days
16242143|NCT01068405|Drug|Methotrexate|Methotrexate: 10mg/week administered in one time, the same day each week (every monday for example)during 12 months
16242144|NCT01068405|Drug|Placebo|Placebo:10mg/week administered in one time, the same day each week (every monday for example)during 12 months
16242145|NCT01068392|Drug|Oxaliplatin, Prednisolone|"OXALIPLATIN+PREDNISOLONE (OX-P)
~D1 Oxaliplatin 130mg/m2 + 5DW 500ml MIV over 2hr
~D1-5 Prednisolone 40-30-30 mg/day P.O
~every 3 weeks"
16242146|NCT01068379|Procedure|criopexy|he cryopexy was performed by placement of a normal spherical probe under the bucklings, around the break. The number of cryo applications was limited in number of 3. Freezing was stopped at the beginning of retinal whitening.
16242147|NCT01068379|Procedure|laser|Laser-retinopexy was performed after proper positioning the patients; laser energy was delivered by depressing a foot pedal. Short burn duration (0.1 seconds) and low (300-miliWatts) power settings were used initially, and both the burn duration and power were gradually increased as determined by observation.
16242148|NCT01068353|Biological|Etanercept|50 mg given as a once weekly subcutaneous injection
16242149|NCT01068353|Other|Placebo|Placebo injection given once weekly
16242150|NCT01068327|Drug|gemcitabine hydrochloride|Given IV
16242151|NCT01068327|Drug|leucovorin calcium|Given IV
16242152|NCT01068327|Drug|fluorouracil|Given IV
16242153|NCT01068327|Drug|nelfinavir mesylate|Given PO
16242154|NCT01068327|Radiation|stereotactic body radiation therapy|Undergo radiotherapy
16242155|NCT01068327|Radiation|hypofractionated radiation therapy|Undergo radiotherapy
16242156|NCT01068327|Procedure|therapeutic conventional surgery|Undergo surgery
16242157|NCT01068314|Other|Repetitive arm exercise|After baseline testing and randomization, subjects in this group are instructed to perform repetitive handgrip exercise with an upper arm compression band until arm fatigue occurs. After resting 1 minute this exercise is repeated 9 times daily for 6 weeks.
16242158|NCT01068301|Drug|Plerixafor|Plerixafor in combination with fludarabine, thiotepa and melphalan as a conditioning regimen for patients undergoing a second allogeneic transplant procedure (bone marrow or peripheral blood). A traditional 3+3 phase I design will be employed during this study, where dose escalations are planned in groups of 3 participants. No intra-participant escalation will be allowed and dose escalation will not be considered until toxicity information is available from at least 3 evaluable participants at the current dose level.Plerixafor will be given intravenously (IV) rather than subcutaneously (SQ) to minimize discomfort associated with repeated daily injections (up to 3) to the pediatric population of this study.
16242159|NCT01068288|Procedure|Laparoscopic or open appendectomy|
16242160|NCT01068288|Procedure|Expectant Management|"A consult to Interventional Radiology will be made at the time of admission to determine whether percutaneous drainage is feasible, and if it is the abscess will be drained by Interventional Radiology. Ultrasound and/or CT scan will be used to follow the abscess collections and/or phlegmons and guide the removal of drains.
~For patients with a fecalith on imaging, a laparoscopic interval appendectomy will be performed 6-12 weeks following discharge from hospital. For those without a fecalith on imaging, a decision will be made by the family, with the guidance of the surgeon, whether or not to undergo a laparoscopic interval appendectomy."
16242161|NCT01068275|Procedure|lumbar plexus catheter|lumbar plexus catheter with 0.2% ropivacaine at 0.15 ml/kg/hr (max 10 ml/hr)
16242162|NCT01068275|Procedure|femoral nerve catheter|femoral nerve catheter with 0.2% ropivacaine at 0.15 ml/kg/hr (max 10 ml/hr)
16242163|NCT01068275|Procedure|single-shot femoral block|single-shot femoral block with 0.2% ropivacaine 0.3 ml/kg (max 20 ml)
16242164|NCT01068262|Drug|Odanacatib|Oral doses of Odanacatib 50 mg administered once weekly for 4 consecutive weeks
16242165|NCT01068262|Drug|Comparator: Placebo|Oral Placebo tablet administered once weekly for 4 consecutive weeks
16242166|NCT01068249|Drug|Letrozole|2.5 mg daily by mouth every day, at same time as Everolimus.
16242167|NCT01068249|Drug|RAD001 (Everolimus)|10 mg by mouth daily
16242168|NCT01068236|Behavioral|Healthy lifestyle managment|Exercise, yoga, food diaries, provider consultation
16242169|NCT01068223|Drug|A:JNJ-39758979/Placebo #1|Single oral dose of JNJ-39758979 600 mg and Placebo
16242170|NCT01068223|Drug|C:Cetirizine/JNJ-39758979 Matching Placebo|JNJ-39758979 Matching Placebo and Placebo #2
16242171|NCT01068223|Drug|B: JNJ-39758979 Matching Placebo /Placebo #2|A single dose of 2 different Placebos
16242174|NCT01068197|Behavioral|Low Glycemic Load Die